相关申请的交叉引用Cross References to Related Applications
本非临时性专利申请为根据35U.S.C.§120的2011年4月29日提交的名称为“Tissue Thickness Compensator For A Surgical Stapler Comprising An AdjustableAnvil”的美国专利申请序列号13/097,891的部分继续申请,该美国专利申请为根据35U.S.C.§120的2010年9月30日提交的名称为“Selectively Orientable ImplantableFastener Cartridge”的美国专利申请序列号12/894,377的部分继续申请,上述专利申请的全部公开内容据此以引用方式并入本文。This nonprovisional patent application is a continuation-in-part of U.S. Patent Application Serial No. 13/097,891, filed April 29, 2011, entitled "Tissue Thickness Compensator For A Surgical Stapler Comprising An Adjustable Anvil," pursuant to 35 U.S.C. §120, This U.S. patent application is a continuation-in-part of U.S. patent application Serial No. 12/894,377, filed September 30, 2010, entitled "Selectively Orientable Implantable Fastener Cartridge," under 35 U.S.C. This is incorporated herein by reference.
背景技术Background technique
本发明涉及外科器械,并且在各种实施例中,本发明涉及被设计成用于切割和缝合组织的外科切割和缝合器械及其钉仓。The present invention relates to surgical instruments, and in various embodiments, the present invention relates to surgical cutting and stapling instruments and staple cartridges thereof designed for cutting and stapling tissue.
发明内容Contents of the invention
以下是受权利要求书保护或可能受权利要求书保护的本发明实施例的不完全列表。The following is a non-exhaustive list of embodiments of the invention that are claimed or that may be claimed.
1.一种组织厚度补偿件,包括:1. A tissue thickness compensator, comprising:
第一层,所述第一层包括被密封地包围在不透水材料中的第一生物相容性材料;和a first layer comprising a first biocompatible material hermetically enclosed in a water-impermeable material; and
第二层,所述第二层包括具有至少一个封装件的第二生物相容性材料;a second layer comprising a second biocompatible material having at least one encapsulation;
其中第一生物相容性材料在与流体接触时膨胀。Wherein the first biocompatible material expands upon contact with a fluid.
2.根据实施例1的组织厚度补偿件,包括具有第三生物相容性材料的第三层,其中所述第一层在所述第二层和第三层中间。2. The tissue thickness compensator of embodiment 1, comprising a third layer having a third biocompatible material, wherein said first layer is intermediate said second and third layers.
3.根据实施例2的组织厚度补偿件,其中所述第一层和第二层中的每一者包括组织接触表面。3. The tissue thickness compensator of embodiment 2, wherein each of the first and second layers comprises a tissue contacting surface.
4.根据实施例2或实施例3的组织厚度补偿件,其中所述第一生物相容性材料、第二生物相容性材料和第三生物相容性材料独立地选自白蛋白、藻酸盐、碳水化合物、酪蛋白、纤维素、甲壳质、脱乙酰壳多糖、胶原、血液、葡聚糖、弹性蛋白、血纤维蛋白、纤维蛋白原、明胶、肝素、透明质酸、角蛋白、蛋白质、血清、淀粉、聚(乳酸)、聚(乙醇酸)、聚(羟基丁酸酯)、聚(膦嗪)、聚酯、聚乙二醇、聚亚烷基氧化物、聚丙烯酰胺、聚碳酸酯、聚甲基丙烯酸羟乙酯、聚(乙烯吡咯烷酮)、聚乙烯醇、聚(己内酯)、聚(二氧杂环己酮)、聚丙烯酸、聚乙酸酯、聚丙烯、甘油、聚(氨基酸)、共聚(醚-酯)、聚亚烷基草酸酯、聚酰胺、聚(亚氨基碳酸酯)、聚氧杂酯、聚原酸酯、聚磷腈、或上述物质的组合。4. The tissue thickness compensator according to embodiment 2 or embodiment 3, wherein said first biocompatible material, second biocompatible material and third biocompatible material are independently selected from albumin, alginic acid Salt, carbohydrates, casein, cellulose, chitin, chitosan, collagen, blood, dextran, elastin, fibrin, fibrinogen, gelatin, heparin, hyaluronic acid, keratin, protein , serum, starch, poly(lactic acid), poly(glycolic acid), poly(hydroxybutyrate), poly(phosphazine), polyester, polyethylene glycol, polyalkylene oxide, polyacrylamide, poly Carbonate, poly(hydroxyethyl methacrylate), poly(vinylpyrrolidone), polyvinyl alcohol, poly(caprolactone), poly(dioxanone), polyacrylic acid, polyacetate, polypropylene, glycerin , poly(amino acid), copoly(ether-ester), polyalkylene oxalate, polyamide, poly(iminocarbonate), polyoxaester, polyorthoester, polyphosphazene, or any of the foregoing combination.
5.根据前述实施例中任一项的组织厚度补偿件,其中所述第一生物相容性材料包括干燥水凝胶。5. The tissue thickness compensator according to any one of the preceding embodiments, wherein said first biocompatible material comprises a dry hydrogel.
6.根据实施例5的组织厚度补偿件,其中所述水凝胶包括选自下列的化合物:亚烷基氧化物、多糖、酯、脂族酯、原酸酯、磷酸酯、碳酸酯、聚氨基甲酸酯、醚、酰胺、酚醛树脂、或上述物质的组合。6. The tissue thickness compensator according to embodiment 5, wherein said hydrogel comprises a compound selected from the group consisting of alkylene oxides, polysaccharides, esters, aliphatic esters, orthoesters, phosphate esters, carbonates, poly Urethanes, ethers, amides, phenolic resins, or combinations thereof.
7.根据前述实施例中任一项的组织厚度补偿件,其中所述第一生物相容性材料是水溶胀性的组合物。7. The tissue thickness compensator according to any one of the preceding embodiments, wherein said first biocompatible material is a water-swellable composition.
8.根据前述实施例中任一项的组织厚度补偿件,其中所述流体包括水、盐水溶液、或体液。8. The tissue thickness compensator according to any one of the preceding embodiments, wherein the fluid comprises water, saline solution, or bodily fluid.
9.根据前述实施例中任一项的组织厚度补偿件,其中当所述不透水材料破裂时,所述第一生物相容性材料接触所述流体。9. A tissue thickness compensator according to any one of the preceding embodiments, wherein said first biocompatible material contacts said fluid when said water impermeable material ruptures.
10.根据前述实施例中任一项的组织厚度补偿件,其中不透水材料包括聚(乳酸)、聚(乙醇酸)、聚(羟基丁酸酯)、聚(膦嗪)、聚酯、聚乙二醇、聚亚烷基氧化物、聚丙烯酰胺、聚碳酸酯、聚甲基丙烯酸羟乙酯、聚(乙烯吡咯烷酮)、聚乙烯醇、聚(己内酯)、聚(二氧杂环己酮)、聚丙烯酸、聚乙酸酯、聚丙烯、甘油、聚(氨基酸)、共聚(醚-酯)、聚亚烷基草酸酯、聚酰胺、聚(亚氨基碳酸酯)、聚氧杂酯、聚原酸酯、聚磷腈,或上述物质的组合。10. The tissue thickness compensator according to any one of the preceding embodiments, wherein the water-impermeable material comprises poly(lactic acid), poly(glycolic acid), poly(hydroxybutyrate), poly(phosphazine), polyester, poly Ethylene glycol, polyalkylene oxide, polyacrylamide, polycarbonate, poly(hydroxyethylmethacrylate), poly(vinylpyrrolidone), polyvinyl alcohol, poly(caprolactone), poly(dioxane hexanone), polyacrylic acid, polyacetate, polypropylene, glycerol, poly(amino acid), copoly(ether-ester), polyalkylene oxalate, polyamide, poly(iminocarbonate), polyoxygen Heteroesters, polyorthoesters, polyphosphazenes, or combinations thereof.
11.根据根据前述实施例中任一项的组织厚度补偿件,其中所述至少一个封装件包括至少一种被封装组分,该被封装组分包括止血剂、抗炎剂、抗生素、抗微生物剂、抗粘合剂、抗凝剂、药物、药物活性剂、或上述物质的组合。11. The tissue thickness compensator according to any one of the preceding embodiments, wherein said at least one package comprises at least one encapsulated component comprising a hemostatic agent, an anti-inflammatory agent, an antibiotic, an antimicrobial agents, anti-adhesives, anticoagulants, drugs, pharmaceutically active agents, or combinations thereof.
12.根据根据实施例11的组织厚度补偿件,其中所述至少一种被封装组分包括抗微生物剂,所述抗微生物剂包括三氯生、氯已定或其盐、银或其盐、铵或其盐、铜或其盐、铁或其盐、锌或其盐、或上述物质的组合。12. The tissue thickness compensator according to embodiment 11, wherein said at least one encapsulated component comprises an antimicrobial agent comprising triclosan, chlorhexidine or a salt thereof, silver or a salt thereof, Ammonium or its salts, copper or its salts, iron or its salts, zinc or its salts, or combinations thereof.
13.根据前述实施例中任一项的组织厚度补偿件,其中所述至少一个封装件包括管,所述管包括聚乙醇酸、聚乳酸、聚二氧杂环己酮、聚羟基链烷酸酯、聚卡普隆、聚已内酯、或上述物质的组合。13. The tissue thickness compensator according to any one of the preceding embodiments, wherein said at least one enclosure comprises a tube comprising polyglycolic acid, polylactic acid, polydioxanone, polyhydroxyalkanoic acid ester, polycapron, polycaprolactone, or a combination of the above.
14.根据前述实施例中任一项的组织厚度补偿件,其中所述至少一个封装件在体内降解。14. The tissue thickness compensator according to any one of the preceding embodiments, wherein said at least one encapsulation degrades in vivo.
15.一种制品,所述制品选自缝合设备的砧座和用于缝合设备的钉仓,所述制品包括实施例1的组织厚度补偿件。15. An article selected from the group consisting of an anvil for a suturing device and a staple cartridge for a suturing device, the article comprising the tissue thickness compensator of embodiment 1.
16.一种组织厚度补偿件,其包括:16. A tissue thickness compensator comprising:
内层,所述内层包括浸渍有止血剂、抗炎剂、抗生素、抗微生物剂、抗粘合剂、抗凝剂、药物、和药物活性剂中的至少一者的水凝胶;和an inner layer comprising a hydrogel impregnated with at least one of a hemostat, an anti-inflammatory, an antibiotic, an antimicrobial, an anti-adhesive, an anti-coagulant, a drug, and a pharmaceutically active agent; and
外层,所述外层包括密封地包围所述内层的不透水材料;an outer layer comprising a water-impermeable material sealingly surrounding the inner layer;
其中所述水凝胶在与水、盐水溶液和体液中的至少一者接触时膨胀。wherein the hydrogel swells upon contact with at least one of water, saline solution, and bodily fluid.
17.根据实施例16的组织厚度补偿件,其中当不透水材料破裂时,所述水凝胶接触水、盐水溶液、或体液,并且其中当所述不透水材料破裂时,止血剂、抗炎剂、抗生素、抗微生物剂、抗粘合剂、抗凝剂、药物和药物活性剂中的至少一者被释放。17. The tissue thickness compensator according to embodiment 16, wherein when the water-impermeable material ruptures, the hydrogel contacts water, saline solution, or bodily fluids, and wherein when the water-impermeable material ruptures, the hemostatic, anti-inflammatory At least one of agents, antibiotics, antimicrobials, anti-adhesives, anticoagulants, drugs, and pharmaceutically active agents is released.
18.一种由包括生物相容性材料的内层和包括密封地包围所述内层的不透水材料的外层制备组织厚度补偿件的方法,该方法包括:18. A method of making a tissue thickness compensator from an inner layer comprising a biocompatible material and an outer layer comprising a water-impermeable material sealingly surrounding said inner layer, the method comprising:
用止血剂、抗炎剂、抗生素、抗微生物剂、抗粘合剂、抗凝剂、药物和药物活性剂中的至少一者浸渍内层;impregnating the inner layer with at least one of a hemostatic agent, an anti-inflammatory agent, an antibiotic, an antimicrobial agent, an anti-adhesive agent, an anti-coagulant, a drug, and a pharmaceutically active agent;
其中生物相容性材料在接触水、盐水溶液和体液中的至少一者时膨胀。wherein the biocompatible material swells upon contact with at least one of water, saline solution, and bodily fluid.
19.实施例18的方法,还包括:19. The method of embodiment 18, further comprising:
使所述不透水材料破裂;以及rupture the impermeable material; and
使所述生物相容性材料与水、盐水溶液和体液中的至少一者接触,以使所述组织厚度补偿件膨胀。The biocompatible material is contacted with at least one of water, saline solution, and bodily fluid to expand the tissue thickness compensator.
附图说明Description of drawings
通过结合附图来参考本发明实施例的以下说明,本发明的特征及优点及其获取方法将会变得更加明显,并可更好地理解发明本身,其中:By referring to the following description of the embodiments of the present invention in conjunction with the accompanying drawings, the features and advantages of the present invention and methods of obtaining them will become more apparent, and the invention itself can be better understood, wherein:
图1是外科器械实施例的剖视图;Figure 1 is a cross-sectional view of a surgical instrument embodiment;
图1A是植入式钉仓的一个实施例的透视图;Figure 1A is a perspective view of one embodiment of an implantable staple cartridge;
图1B-图1E示出了用植入式钉仓夹持和缝合组织的端部执行器的多个部分;1B-1E illustrate portions of an end effector for clamping and stapling tissue with an implantable staple cartridge;
图2是联接到外科器械的一部分的另一个端部执行器的局部横截面侧视图,其中端部执行器支撑外科钉仓并且其砧座处于打开位置;2 is a partial cross-sectional side view of another end effector coupled to a portion of a surgical instrument, wherein the end effector supports a surgical staple cartridge and its anvil is in an open position;
图3是图2所示的端部执行器处于闭合位置的另一局部横截面侧视图;3 is another partial cross-sectional side view of the end effector shown in FIG. 2 in a closed position;
图4是图2和图3所示的端部执行器在刀杆开始穿过端部执行器推进时另一局部横截面侧视图;4 is another partial cross-sectional side view of the end effector shown in FIGS. 2 and 3 as the knife bar begins to advance through the end effector;
图5是图2至图4所示的端部执行器在刀杆被部分地推进穿过其中时的另一局部横截面侧视图;5 is another partial cross-sectional side view of the end effector shown in FIGS. 2-4 with the knife bar partially advanced therethrough;
图6A-图6D描绘根据至少一个实施例定位在可塌缩钉仓体内的外科钉的变形;6A-6D depict deformation of a surgical staple positioned within a collapsible staple cartridge body, according to at least one embodiment;
图7A为示出定位在可压溃钉仓体中的钉的示意图;Figure 7A is a schematic diagram showing a staple positioned in a crushable staple cartridge body;
图7B为示出图7A的可压溃钉仓体被砧座压溃的示意图;7B is a schematic diagram showing the crushable staple cartridge body of FIG. 7A being crushed by an anvil;
图7C为示出图7A的可压溃钉仓体被砧座进一步压溃的示意图;7C is a schematic diagram showing the crushable staple cartridge body of FIG. 7A being further crushed by the anvil;
图7D为示出图7A的钉处于完全成形构型并且图7A的可压溃钉仓处于完全压溃条件的示意图;7D is a schematic diagram showing the staple of FIG. 7A in a fully formed configuration and the crushable staple cartridge of FIG. 7A in a fully crushed condition;
图8为根据至少一个实施例的钉仓的顶视图,该钉仓包括嵌入可塌缩钉仓体中的钉;8 is a top view of a staple cartridge including staples embedded in a collapsible staple cartridge body in accordance with at least one embodiment;
图9为图8的钉仓的正视图;Fig. 9 is a front view of the staple cartridge of Fig. 8;
图10为可压缩钉仓的另选的实施例的分解透视图,该可压缩钉仓中包括钉和用于抵靠砧座来驱动钉的系统;10 is an exploded perspective view of an alternative embodiment of a compressible staple cartridge including staples and a system for driving the staples against an anvil;
图10A为图10的钉仓的另选的实施例的局部剖视图;10A is a partial cross-sectional view of an alternative embodiment of the staple cartridge of FIG. 10;
图11为图10的钉仓的剖面图;Fig. 11 is a sectional view of the staple cartridge of Fig. 10;
图12为能够横贯图10的钉仓并使钉朝砧座运动的滑动件的正视图;Figure 12 is a front view of a slider capable of traversing the staple cartridge of Figure 10 and moving the staples toward the anvil;
图13为可由图12的滑动件朝向砧座提升的钉驱动器的示意图;Figure 13 is a schematic view of a staple driver that can be lifted toward the anvil by the slide of Figure 12;
图14是根据本发明的至少一个实施例的钉仓的透视图,钉仓包括与外科缝合器械一起使用的刚性支撑部分和可压缩的组织厚度补偿件;14 is a perspective view of a staple cartridge including a rigid support portion and a compressible tissue thickness compensator for use with a surgical stapling instrument in accordance with at least one embodiment of the present invention;
图15是图14的钉仓的局部分解图;Figure 15 is a partial exploded view of the staple cartridge of Figure 14;
图16是图14的钉仓的完全分解图;Figure 16 is a fully exploded view of the staple cartridge of Figure 14;
图17是图14的钉仓的另一个分解图,该钉仓没有覆盖组织厚度补偿件的包裹物;17 is another exploded view of the staple cartridge of FIG. 14 without the wrap covering the tissue thickness compensator;
图18是图14的钉仓的仓体或支撑部分的透视图;18 is a perspective view of the cartridge body or support portion of the staple cartridge of FIG. 14;
图19是滑动件的顶部透视图,该滑动件能够在图14的钉仓内运动,以从钉仓部署钉;19 is a top perspective view of a sled movable within the staple cartridge of FIG. 14 to deploy staples from the staple cartridge;
图20是图19的滑动件的底部透视图;Figure 20 is a bottom perspective view of the slider of Figure 19;
图21是图19的滑动件的正视图;Figure 21 is a front view of the slider of Figure 19;
图22是驱动器的顶部透视图,该驱动器能够支撑一个或多个钉,并被图19的滑动件向上抬起以将钉从钉仓射出;Figure 22 is a top perspective view of a driver capable of supporting one or more staples and lifted upward by the slide of Figure 19 to eject the staples from the staple cartridge;
图23是图22的驱动器的底部透视图;Figure 23 is a bottom perspective view of the driver of Figure 22;
图24是能够至少部分地围绕钉仓的可压缩组织厚度补偿件的包裹物;24 is a wrap capable of at least partially surrounding a compressible tissue thickness compensator of a staple cartridge;
图25是钉仓的局部剖视图,钉仓包括刚性支撑部分和可压缩的组织厚度补偿件,示出了钉在第一序列期间从未击发位置运动到击发位置;25 is a partial cross-sectional view of a staple cartridge including a rigid support portion and a compressible tissue thickness compensator, showing movement of the staples from an unfired position to a fired position during a first sequence;
图26是图25的钉仓的正视图;Figure 26 is a front view of the staple cartridge of Figure 25;
图27是图25的钉仓的细部正视图;Figure 27 is a detailed front view of the staple cartridge of Figure 25;
图28是图25的钉仓的剖面端视图;Figure 28 is a cross-sectional end view of the staple cartridge of Figure 25;
图29是图25的钉仓的底视图;Figure 29 is a bottom view of the staple cartridge of Figure 25;
图30是图25的钉仓的细部底视图;Figure 30 is a detailed bottom view of the staple cartridge of Figure 25;
图31是钉仓和处于闭合位置的砧座的纵向剖面图,钉仓包括刚性支撑部分和可压缩的组织厚度补偿件,示出了钉在第一序列期间从未击发位置运动到击发位置;31 is a longitudinal cross-sectional view of a staple cartridge and an anvil in a closed position, the staple cartridge including a rigid support portion and a compressible tissue thickness compensator, showing movement of the staples from an unfired position to a fired position during a first sequence;
图32是图31的砧座和钉仓的另一个剖面图,示出了当击发序列完成之后处于打开位置的砧座;32 is another cross-sectional view of the anvil and staple cartridge of FIG. 31, showing the anvil in an open position after the firing sequence is complete;
图33是图31的钉仓的局部细部图,示出了处于未击发位置的钉;Figure 33 is a partial detail view of the staple cartridge of Figure 31, showing the staples in an unfired position;
图34是钉仓的剖面正视图,该钉仓包括刚性支撑部分和可压缩的组织厚度补偿件,示出了处于未击发位置的钉;34 is a cross-sectional front view of a staple cartridge including a rigid support portion and a compressible tissue thickness compensator, showing the staples in an unfired position;
图35是图34的钉仓的细部图;Figure 35 is a detailed view of the staple cartridge of Figure 34;
图36是钉仓和处于打开位置的砧座的正视图,钉仓包括刚性支撑部分和可压缩的组织厚度补偿件,示出了处于未击发位置的钉;36 is a front view of a staple cartridge and an anvil in an open position, the staple cartridge including a rigid support portion and a compressible tissue thickness compensator, showing the staples in an unfired position;
图37是钉仓和处于闭合位置的砧座的正视图,钉仓包括刚性支撑部分和可压缩的组织厚度补偿件,示出了处于未击发位置的钉以及被捕获在砧座和组织厚度补偿件之间的组织;37 is a front view of a staple cartridge and anvil in a closed position, the staple cartridge including a rigid support portion and a compressible tissue thickness compensator, showing the staples in an unfired position and captured on the anvil and tissue thickness compensator organization between pieces;
图38是图37的砧座和钉仓的细部图;Figure 38 is a detailed view of the anvil and staple cartridge of Figure 37;
图39是钉仓和处于闭合位置的砧座的正视图,钉仓包括刚性支撑部分和可压缩的组织厚度补偿件,示出了处于未击发位置的钉,示出了被定位在砧座和钉仓之间的较厚的组织;39 is a front view of a staple cartridge and an anvil in a closed position, the staple cartridge including a rigid support portion and a compressible tissue thickness compensator, shown in an unfired position, showing the staples positioned on the anvil and Thicker tissue between staple cartridges;
图40是图39的砧座和钉仓的细部图;Figure 40 is a detailed view of the anvil and staple cartridge of Figure 39;
图41是图39的砧座和钉仓的正视图,示出了被定位在砧座和钉仓之间的具有不同厚度的组织;Fig. 41 is a front view of the anvil and staple cartridge of Fig. 39, showing tissue having different thicknesses positioned between the anvil and the staple cartridge;
图42是图39的砧座和钉仓的细部图,如图41所示;Figure 42 is a detailed view of the anvil block and the staple cartridge of Figure 39, as shown in Figure 41;
图43是示出了对被捕获在不同钉内的不同组织厚度进行补偿的组织厚度补偿件的示意图;43 is a schematic diagram illustrating a tissue thickness compensator compensating for different tissue thicknesses captured within different staples;
图44是示出了组织厚度补偿件向被钉线横切的一根或多根血管施加压缩压力的示意图;44 is a schematic diagram illustrating the application of compressive pressure by a tissue thickness compensator to one or more blood vessels transected by a staple wire;
图45是示出了其中一个或多个钉未恰当成形的情况的示意图;Figure 45 is a schematic diagram illustrating a situation where one or more staples are not properly formed;
图46是示出了可补偿未恰当成形钉的组织厚度补偿件的示意图;46 is a schematic diagram showing a tissue thickness compensator that can compensate for improperly formed staples;
图47是示出了被定位在多个钉线相交的组织区域中的组织厚度补偿件的示意图;47 is a schematic diagram showing a tissue thickness compensator positioned in a tissue region where multiple staple lines intersect;
图48是示出了被捕获在钉内的组织的示意图;Figure 48 is a schematic diagram showing tissue captured within a staple;
图49是示出了被捕获在钉内的组织和组织厚度补偿件的示意图;49 is a schematic diagram showing tissue and tissue thickness compensator captured within a staple;
图50是示出了被捕获在钉内的组织的示意图;Figure 50 is a schematic diagram showing tissue captured within a staple;
图51是示出了被捕获在钉内的厚组织和组织厚度补偿件的示意图;Figure 51 is a schematic diagram showing thick tissue and tissue thickness compensator captured within a staple;
图52是示出了被捕获在钉内的薄组织和组织厚度补偿件的示意图;52 is a schematic diagram showing thin tissue and tissue thickness compensator captured within a staple;
图53是示出了被捕获在钉内的组织厚度补偿件以及具有中间厚度的组织的示意图;53 is a schematic diagram showing a tissue thickness compensator captured within a staple and tissue having an intermediate thickness;
图54是示出了被捕获在钉内的组织厚度补偿件以及具有另一中间厚度的组织的示意图;54 is a schematic diagram showing a tissue thickness compensator captured within a staple and tissue having another intermediate thickness;
图55是示出了被捕获在钉内的厚组织和组织厚度补偿件的示意图;55 is a schematic diagram showing thick tissue and tissue thickness compensator captured within a staple;
图56是外科缝合器械的端部执行器的局部剖面图,示出了处于回缩、未击发位置的击发杆和钉击发滑动件;56 is a partial cross-sectional view of an end effector of a surgical stapling instrument showing the firing bar and staple firing sled in a retracted, unfired position;
图57是图56的端部执行器的另一个局部剖面图,示出了处于局部推进位置的击发杆和钉击发滑动件;57 is another partial cross-sectional view of the end effector of FIG. 56, showing the firing rod and nail firing sled in a partially advanced position;
图58是图56的端部执行器的剖面图,示出了处于完全推进或击发位置的击发杆;Figure 58 is a cross-sectional view of the end effector of Figure 56, showing the firing rod in a fully advanced or fired position;
图59是图56的端部执行器的剖面图,示出了在被击发后处于回缩位置的击发杆以及留在其完全击发位置的钉击发滑动件;59 is a cross-sectional view of the end effector of FIG. 56 showing the firing rod in the retracted position after being fired and the nail firing sled remaining in its fully fired position;
图60是图59的处于回缩位置的击发杆的细部图;Figure 60 is a detail view of the firing rod of Figure 59 in the retracted position;
图61是根据至少一个实施例的在外科器械的端部执行器中的组织厚度补偿件的透视图;61 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument in accordance with at least one embodiment;
图62是图61的组织厚度补偿件的非织造材料的细部图;62 is a detail view of the nonwoven material of the tissue thickness compensator of FIG. 61;
图63是示出抵靠组织被植入并且从端部执行器释放的图61的组织厚度补偿件的正视图;63 is an elevation view showing the tissue thickness compensator of FIG. 61 implanted against tissue and released from the end effector;
图64是根据至少一个实施例的组织厚度补偿件的非织造材料的细部图;Figure 64 is a detail view of the nonwoven material of a tissue thickness compensator according to at least one embodiment;
图65是根据至少一个实施例示出了无规取向的卷曲纤维的集群的示意图;Figure 65 is a schematic diagram showing clusters of randomly oriented crimped fibers, according to at least one embodiment;
图66是根据至少一个实施例示出了无规取向的卷曲纤维的集群的示意图;Figure 66 is a schematic diagram showing clusters of randomly oriented crimped fibers, according to at least one embodiment;
图67是根据至少一个实施例示出了卷曲纤维的构造的示意图;Figure 67 is a schematic diagram illustrating the configuration of crimped fibers, according to at least one embodiment;
图68是根据至少一个实施例示出了卷曲纤维的构造的示意图;Figure 68 is a schematic diagram illustrating the configuration of crimped fibers, according to at least one embodiment;
图69是根据至少一个实施例示出了卷曲纤维的构造的示意图;Figure 69 is a schematic diagram illustrating the configuration of crimped fibers, according to at least one embodiment;
图70是根据至少一个实施例的组织厚度补偿件中的盘绕纤维的平面剖视图;Figure 70 is a cross-sectional plan view of coiled fibers in a tissue thickness compensator according to at least one embodiment;
图70A是图70的盘绕纤维的平面剖视图;Figure 70A is a planar cross-sectional view of the coiled fiber of Figure 70;
图70B是图70的组织厚度补偿件的剖面细部图;70B is a cross-sectional detail view of the tissue thickness compensator of FIG. 70;
图71是根据至少一个实施例的在外科器械的端部执行器中的组织厚度补偿件的透视图;71 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument in accordance with at least one embodiment;
图72是示出图71的组织厚度补偿件的变形的示意图;Figure 72 is a schematic diagram illustrating deformation of the tissue thickness compensator of Figure 71;
图73是根据至少一个实施例的组织厚度补偿件的织造缝合线的示意图,其示出了处于加载构型中的织造缝合线;73 is a schematic illustration of a woven suture of a tissue thickness compensator showing the woven suture in a loaded configuration, according to at least one embodiment;
图74是图73的织造缝合线的示意图,其示出了处于释放构型的织造缝合线;Figure 74 is a schematic illustration of the woven suture of Figure 73, showing the woven suture in a released configuration;
图75是外科器械的端部执行器中具有图73的织造缝合线的组织厚度补偿件的平面图;75 is a plan view of a tissue thickness compensator with the woven suture of FIG. 73 in an end effector of a surgical instrument;
图76是根据至少一个实施例的在外科器械的端部执行器中的组织厚度补偿件的透视图;76 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument in accordance with at least one embodiment;
图77是图76的组织厚度补偿件的局部平面图;Figure 77 is a partial plan view of the tissue thickness compensator of Figure 76;
图78是图61的端部执行器和组织厚度补偿件的紧固件仓组件的分解图;78 is an exploded view of the fastener cartridge assembly of the end effector and tissue thickness compensator of FIG. 61;
图79是图78的紧固件仓组件的局部剖视图,其示出了未击发、部分击发以及击发的紧固件;79 is a partial cross-sectional view of the fastener cartridge assembly of FIG. 78 showing unfired, partially fired, and fired fasteners;
图80是图78的紧固件仓组件的正视图,其示出了驱动器击发紧固件从紧固件仓组件的钉腔进入到组织厚度补偿件;80 is a front view of the fastener cartridge assembly of FIG. 78 showing the driver firing fasteners from the staple cavities of the fastener cartridge assembly into the tissue thickness compensator;
图81是图80的紧固件仓组件的细部图;Figure 81 is a detail view of the fastener cartridge assembly of Figure 80;
图82是图61的组织厚度补偿件以及捕获在击发紧固件内的组织的正视图;82 is a front view of the tissue thickness compensator of FIG. 61 and tissue captured within the fired fastener;
图83是图61的组织厚度补偿件以及捕获在击发紧固件内的组织的正视图;83 is a front view of the tissue thickness compensator of FIG. 61 and tissue captured within the fired fastener;
图84是根据至少一个实施例的在外科器械的端部执行器中的组织厚度补偿件的透视图;84 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument in accordance with at least one embodiment;
图85是示出图84的组织厚度补偿件的可变形管的变形的示意图;85 is a schematic diagram illustrating deformation of the deformable tube of the tissue thickness compensator of FIG. 84;
图86是图84的组织厚度补偿件的可变形管的细部图;86 is a detail view of the deformable tube of the tissue thickness compensator of FIG. 84;
图87是根据至少一个实施例示出组织厚度补偿件的可变形管的变形的示意图;Figure 87 is a schematic diagram illustrating deformation of a deformable tube of a tissue thickness compensator, according to at least one embodiment;
图88是根据至少一个实施例的组织厚度补偿件的正视图,该组织厚度补偿件包括抵靠组织植入的管状元件;88 is an elevational view of a tissue thickness compensator comprising a tubular element implanted against tissue, according to at least one embodiment;
图89是根据至少一个实施例的组织厚度补偿件的正视图,该组织厚度补偿件包括抵靠组织植入的管状元件;89 is an elevational view of a tissue thickness compensator comprising a tubular element implanted against tissue, according to at least one embodiment;
图90是根据至少一个实施例的包括管状晶格的可变形管的局部透视图;Figure 90 is a partial perspective view of a deformable tube comprising a tubular lattice, according to at least one embodiment;
图91是图90的可变形管的管状股线的正视图。91 is a front view of a tubular strand of the deformable tube of FIG. 90. FIG.
图92是图90的可变形管的正视图;Figure 92 is a front view of the deformable tube of Figure 90;
图93是根据各种实施例的用于图90的可变形管的多个管状股线的正视图;Figure 93 is a front view of a plurality of tubular strands for the deformable tube of Figure 90, according to various embodiments;
图94是抵靠组织植入的图90的管状晶格的正视图;Figure 94 is a front view of the tubular lattice of Figure 90 implanted against tissue;
图95是根据至少一个实施例的可变形管的局部透视图;Figure 95 is a partial perspective view of a deformable tube according to at least one embodiment;
图96是根据至少一个实施例的可变形管的局部透视图;Figure 96 is a partial perspective view of a deformable tube according to at least one embodiment;
图97是根据至少一个实施例的可变形管的局部透视图;Figure 97 is a partial perspective view of a deformable tube according to at least one embodiment;
图98是图97的可变形管的正视图;Figure 98 is a front view of the deformable tube of Figure 97;
图99是根据至少一个实施例的可变形管的局部透视图;Figure 99 is a partial perspective view of a deformable tube according to at least one embodiment;
图100是根据至少一个实施例的可变形管的局部透视图;Figure 100 is a partial perspective view of a deformable tube according to at least one embodiment;
图101是根据至少一个实施例的可变形管的局部透视图;Figure 101 is a partial perspective view of a deformable tube according to at least one embodiment;
图102是根据至少一个实施例的组织厚度补偿件的透视图,该组织厚度补偿件定位在外科器械的端部执行器中;102 is a perspective view of a tissue thickness compensator positioned in an end effector of a surgical instrument in accordance with at least one embodiment;
图103是图102的组织厚度补偿件的管状元件的正视图;103 is a front view of the tubular element of the tissue thickness compensator of FIG. 102;
图104是图102的组织厚度补偿件和端部执行器的正剖视图,其示出了处于未夹紧构型的端部执行器;104 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 102, showing the end effector in an unclamped configuration;
图105是图102的组织厚度补偿件和端部执行器的正剖视图,其示出了处于夹紧和击发构型的端部执行器;105 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 102, showing the end effector in a clamped and fired configuration;
图106是根据至少一个实施例的组织厚度补偿件的正剖视图,该组织厚度补偿件定位在外科器械的端部执行器中;106 is an elevational cross-sectional view of a tissue thickness compensator positioned in an end effector of a surgical instrument in accordance with at least one embodiment;
图107是图106的组织厚度补偿件和端部执行器的正剖视图,其示出了处于夹紧和击发构型的端部执行器;107 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 106, showing the end effector in a clamped and fired configuration;
图108是根据至少一个实施例的在外科器械的端部执行器中的组织厚度补偿件的正剖视图;108 is an elevational cross-sectional view of a tissue thickness compensator in an end effector of a surgical instrument in accordance with at least one embodiment;
图109是根据至少一个实施例的组织厚度补偿件的正剖视图,该组织厚度补偿件定位在外科器械的端部执行器中;109 is an elevational cross-sectional view of a tissue thickness compensator positioned in an end effector of a surgical instrument in accordance with at least one embodiment;
图110是图109的组织厚度补偿件和端部执行器的正剖视图,其示出了处于夹紧和击发构型的端部执行器;Figure 110 is an elevational cross-sectional view of the tissue thickness compensator and end effector of Figure 109, showing the end effector in a clamped and fired configuration;
图111是根据至少一个实施例的组织厚度补偿件的透视图,该组织厚度补偿件定位在外科器械的端部执行器中;111 is a perspective view of a tissue thickness compensator positioned in an end effector of a surgical instrument, according to at least one embodiment;
图112是根据至少一个实施例的组织厚度补偿件的正剖视图,该组织厚度补偿件定位在外科器械的端部执行器中;112 is an elevational cross-sectional view of a tissue thickness compensator positioned in an end effector of a surgical instrument in accordance with at least one embodiment;
图113是根据至少一个实施例的组织厚度补偿件的正剖视图,该组织厚度补偿件定位在外科器械的端部执行器中;113 is an elevational cross-sectional view of a tissue thickness compensator positioned in an end effector of a surgical instrument in accordance with at least one embodiment;
图114是根据至少一个实施例的组织厚度补偿件的正剖视图,该组织厚度补偿件定位在外科器械的端部执行器中;114 is an elevational cross-sectional view of a tissue thickness compensator positioned in an end effector of a surgical instrument in accordance with at least one embodiment;
图115是根据至少一个实施例的组织厚度补偿件的正剖视图,该组织厚度补偿件定位在外科器械的端部执行器中;115 is an elevational cross-sectional view of a tissue thickness compensator positioned in an end effector of a surgical instrument in accordance with at least one embodiment;
图116是根据至少一个实施例的组织厚度补偿件的局部平面图,该组织厚度补偿件定位在外科器械的端部执行器中;116 is a partial plan view of a tissue thickness compensator positioned in an end effector of a surgical instrument in accordance with at least one embodiment;
图117是根据至少一个实施例的组织厚度补偿件的局部平面图,该组织厚度补偿件定位在外科器械的端部执行器中;117 is a partial plan view of a tissue thickness compensator positioned in an end effector of a surgical instrument in accordance with at least one embodiment;
图118是图116的组织厚度补偿件和端部执行器的局部正剖视图,其示出了处于未夹紧构型的端部执行器;118 is a partial front cross-sectional view of the tissue thickness compensator and end effector of FIG. 116, showing the end effector in an unclamped configuration;
图119是图116的组织厚度补偿件和端部执行器的局部正剖视图,其示出了处于夹紧构型的端部执行器;119 is a partial front cross-sectional view of the tissue thickness compensator and end effector of FIG. 116, showing the end effector in a clamped configuration;
图120是根据至少一个实施例的在外科器械的端部执行器中的组织厚度补偿件的透视图;Figure 120 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument in accordance with at least one embodiment;
图121是图120的组织厚度补偿件和端部执行器的正视图;Figure 121 is a front view of the tissue thickness compensator and end effector of Figure 120;
图122是图120的组织厚度补偿件和端部执行器的透视图,其示出了朝向夹紧构型运动的端部执行器的砧座;122 is a perspective view of the tissue thickness compensator and end effector of FIG. 120 showing the anvil of the end effector moved toward the clamped configuration;
图123是图120的组织厚度补偿件和端部执行器的正视图,其示出了处于夹紧构型的端部执行器;123 is a front view of the tissue thickness compensator and end effector of FIG. 120, showing the end effector in a clamped configuration;
图124是处于未变形构型的图120的组织厚度补偿件的管状元件的正剖视图;124 is an elevational cross-sectional view of the tubular element of the tissue thickness compensator of FIG. 120 in an undeformed configuration;
图125是处于变形构型的图120的组织厚度补偿件的管状元件的正剖视图;125 is an elevational cross-sectional view of the tubular element of the tissue thickness compensator of FIG. 120 in a deformed configuration;
图126是根据至少一个实施例的在外科器械的端部执行器中的组织厚度补偿件的透视图;126 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument in accordance with at least one embodiment;
图127是图126的组织厚度补偿件和端部执行器的正剖视图,其示出了处于夹紧构型的端部执行器;127 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 126, showing the end effector in a clamped configuration;
图128是图126的组织厚度补偿件和端部执行器的正剖视图,其示出了处于击发和部分未夹紧构型的端部执行器;128 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 126, showing the end effector in a fired and partially unclamped configuration;
图129是根据至少一个实施例的组织厚度补偿件的透视图,该组织厚度补偿件定位在外科器械的端部执行器中;129 is a perspective view of a tissue thickness compensator positioned in an end effector of a surgical instrument in accordance with at least one embodiment;
图130是根据至少一个实施例的组织厚度补偿件的正剖视图,该组织厚度补偿件固定到外科器械端部执行器的砧座;130 is an elevational cross-sectional view of a tissue thickness compensator secured to an anvil of a surgical instrument end effector in accordance with at least one embodiment;
图131是图130的组织厚度补偿件和端部执行器的正剖视图,其示出了处于夹紧构型的端部执行器;131 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 130, showing the end effector in a clamped configuration;
图132是图130的组织厚度补偿件和端部执行器的正剖视图,其示出了处于击发和部分未夹紧构型的端部执行器;132 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 130, showing the end effector in a fired and partially unclamped configuration;
图133是图132的组织厚度补偿件和端部执行器的细部图;Figure 133 is a detail view of the tissue thickness compensator and end effector of Figure 132;
图134是根据至少一个实施例的夹紧在外科器械的端部执行器中的组织厚度补偿件的正剖视图,其示出了通过钉击发滑动件部署钉;134 is an elevational cross-sectional view of a tissue thickness compensator clamped in an end effector of a surgical instrument showing deployment of staples by the staple firing sled, in accordance with at least one embodiment;
图135是图134的组织厚度补偿件和端部执行器的正剖视图,其示出了处于夹紧构型的端部执行器;135 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 134, showing the end effector in a clamped configuration;
图136是图134的组织厚度补偿件和端部执行器的正剖视图,其示出了处于击发构型的端部执行器;136 is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 134, showing the end effector in a fired configuration;
图137是根据至少一个实施例的在外科器械的端部执行器中的组织厚度补偿件的透视图;137 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument in accordance with at least one embodiment;
图138是图137的组织厚度补偿件的管状元件的透视图;138 is a perspective view of a tubular element of the tissue thickness compensator of FIG. 137;
图139是在第一末端和第二末端之间被切断的图138的管状元件的透视图;Figure 139 is a perspective view of the tubular element of Figure 138 cut away between the first end and the second end;
图140是图137的组织厚度补偿件的透视图,其示出了切断组织厚度补偿件的切割元件以及接合组织厚度补偿件的钉;FIG. 140 is a perspective view of the tissue thickness compensator of FIG. 137 showing cutting elements severing the tissue thickness compensator and staples engaging the tissue thickness compensator;
图141是根据至少一个实施例的能够制成图137的组织厚度补偿件的框架的透视图;141 is a perspective view of a frame from which the tissue thickness compensator of FIG. 137 can be made, according to at least one embodiment;
图142是图141的框架的正剖视图,其示出了在框架中固化的图137的组织厚度补偿件;Figure 142 is an elevational cross-sectional view of the frame of Figure 141 showing the tissue thickness compensator of Figure 137 cured in the frame;
图143是从图142的框架移除并且被制备用于由至少一个切割器械进行修剪的组织厚度补偿件的正剖视图;143 is an elevational cross-sectional view of a tissue thickness compensator removed from the frame of FIG. 142 and prepared for trimming by at least one cutting instrument;
图144是在至少一个切割器械对组织厚度补偿件进行修剪之后的图143的组织厚度补偿件的正剖视图;144 is an elevational cross-sectional view of the tissue thickness compensator of FIG. 143 after at least one cutting instrument has trimmed the tissue thickness compensator;
图145是在图142的框架中形成的组织厚度补偿件的正剖视图,其示出了具有各种横截面几何形状的可切断管;Fig. 145 is an elevational cross-sectional view of a tissue thickness compensator formed in the frame of Fig. 142, showing severable tubes having various cross-sectional geometries;
图146是根据至少一个实施例的在外科器械的端部执行器中的组织厚度补偿件的透视图;Figure 146 is a perspective view of a tissue thickness compensator in an end effector of a surgical instrument in accordance with at least one embodiment;
图147是根据至少一个实施例的图146的组织厚度补偿件的细部图;Figure 147 is a detail view of the tissue thickness compensator of Figure 146, according to at least one embodiment;
图148是根据至少一个实施例的组织厚度补偿件的局部透视图;Figure 148 is a partial perspective view of a tissue thickness compensator according to at least one embodiment;
图149是根据至少一个实施例的组织厚度补偿件的局部透视图;Figure 149 is a partial perspective view of a tissue thickness compensator according to at least one embodiment;
图150A是图146的组织厚度补偿件和端部执行器的正剖视图,其示出了处于未夹紧构型的端部执行器;150A is an elevational cross-sectional view of the tissue thickness compensator and end effector of FIG. 146, showing the end effector in an unclamped configuration;
图150B是图146的组织厚度补偿件和端部执行器的正剖视图,其示出了处于夹紧构型的端部执行器;Figure 150B is an elevational cross-sectional view of the tissue thickness compensator and end effector of Figure 146, showing the end effector in a clamped configuration;
图150C是图146的组织厚度补偿件和端部执行器的正剖视图,其示出了处于夹紧和击发构型的端部执行器;Figure 150C is an elevational cross-sectional view of the tissue thickness compensator and end effector of Figure 146, showing the end effector in a clamped and fired configuration;
图150D是捕获在击发钉中的图146的组织厚度补偿件的正剖视图;150D is an elevational cross-sectional view of the tissue thickness compensator of FIG. 146 captured in a fired staple;
图150E是捕获在击发钉中的图146的组织厚度补偿件的正剖视图,其示出了组织厚度补偿件的进一步膨胀;150E is an elevational cross-sectional view of the tissue thickness compensator of FIG. 146 captured in a fired staple showing further expansion of the tissue thickness compensator;
图151是根据至少一个实施例的在外科器械的端部执行器中的组织厚度补偿件的透视剖视图;151 is a perspective cross-sectional view of a tissue thickness compensator in an end effector of a surgical instrument in accordance with at least one embodiment;
图152是捕获在击发钉中的图151的组织厚度补偿件的局部正视图;152 is a partial front view of the tissue thickness compensator of FIG. 151 captured in a fired staple;
图153是图151的组织厚度补偿件的可变形管的正视图;153 is a front view of the deformable tube of the tissue thickness compensator of FIG. 151;
图154是根据至少一个实施例的可变形管的正视图;Figure 154 is a front view of a deformable tube in accordance with at least one embodiment;
图155是图151的组织厚度补偿件的透视剖视图;155 is a perspective cutaway view of the tissue thickness compensator of FIG. 151;
图156是根据至少一个实施例的在外科器械的端部执行器中的组织厚度补偿件的透视剖视图;156 is a perspective cross-sectional view of a tissue thickness compensator in an end effector of a surgical instrument in accordance with at least one embodiment;
图157是根据至少一个实施例的组织厚度补偿件的透视图;Figure 157 is a perspective view of a tissue thickness compensator according to at least one embodiment;
图158是图157的组织厚度补偿件的局部正剖视图,其示出了与组织以及与组织厚度补偿件接合的紧固件;Fig. 158 is a partial front cross-sectional view of the tissue thickness compensator of Fig. 157, showing fasteners engaged with tissue and with the tissue thickness compensator;
图159是根据至少一个实施例的组织厚度补偿件的透视剖视图;Figure 159 is a perspective cross-sectional view of a tissue thickness compensator according to at least one embodiment;
图160是根据至少一个实施例的组织厚度补偿件的正视图;Figure 160 is a front view of a tissue thickness compensator according to at least one embodiment;
图161是根据至少一个实施例的组织厚度补偿件的正视图;Figure 161 is a front view of a tissue thickness compensator according to at least one embodiment;
图162是根据至少一个实施例的组织厚度补偿件的正视图,该组织厚度补偿件定位在外科器械的圆形端部执行器中;162 is a front view of a tissue thickness compensator positioned in a circular end effector of a surgical instrument, according to at least one embodiment;
图163是根据至少一个实施例的组织厚度补偿件的正视图;Figure 163 is a front view of a tissue thickness compensator according to at least one embodiment;
图164是根据至少一个实施例的组织厚度补偿件的正视图;Figure 164 is a front view of a tissue thickness compensator according to at least one embodiment;
图165是根据至少一个实施例的组织厚度补偿件的正视图;Figure 165 is a front view of a tissue thickness compensator according to at least one embodiment;
图166是根据至少一个实施例的组织厚度补偿件的正视图;Figure 166 is a front view of a tissue thickness compensator according to at least one embodiment;
图167是根据至少一个实施例的组织厚度补偿件的正视图;Figure 167 is a front view of a tissue thickness compensator according to at least one embodiment;
图168是根据至少一个实施例的组织厚度补偿件的局部透视图;Figure 168 is a partial perspective view of a tissue thickness compensator according to at least one embodiment;
图169是根据至少一个实施例的组织厚度补偿件的局部透视图,该组织厚度补偿件定位在外科器械的端部执行器中;169 is a partial perspective view of a tissue thickness compensator positioned in an end effector of a surgical instrument in accordance with at least one embodiment;
图170是根据至少一个实施例的组织厚度补偿件的局部透视图,该组织厚度补偿件具有定位在其孔中的紧固件;Figure 170 is a partial perspective view of a tissue thickness compensator having fasteners positioned in holes thereof in accordance with at least one embodiment;
图171是图169的组织厚度补偿件的局部透视图,其示出了处于未变形构型的组织厚度补偿件;Figure 171 is a partial perspective view of the tissue thickness compensator of Figure 169, showing the tissue thickness compensator in an undeformed configuration;
图172是图169的组织厚度补偿件的局部透视图,其示出了处于部分变形构型的组织厚度补偿件;Figure 172 is a partial perspective view of the tissue thickness compensator of Figure 169, showing the tissue thickness compensator in a partially deformed configuration;
图173是图169的组织厚度补偿件的局部透视图,其示出了处于变形构型的组织厚度补偿件;Figure 173 is a partial perspective view of the tissue thickness compensator of Figure 169, showing the tissue thickness compensator in a deformed configuration;
图174是根据至少一个实施例的组织厚度补偿件的透视图;Figure 174 is a perspective view of a tissue thickness compensator according to at least one embodiment;
图175是根据至少一个实施例的包括砧座和钉仓的缝合器械的端部执行器的透视图;Figure 175 is a perspective view of an end effector of a stapling instrument including an anvil and a staple cartridge in accordance with at least one embodiment;
图176是图175的端部执行器的剖视图,其示出了定位在钉仓内的处于未击发状态的钉以及包括处于未刺穿状态的密封容器的组织厚度补偿件,其中为了说明的目的,容器被示为其部分被移除;176 is a cross-sectional view of the end effector of FIG. 175 showing the staples positioned within the staple cartridge in an unfired state and a tissue thickness compensator including a sealed container in an unpierced state, wherein for purposes of illustration , the container is shown with its parts removed;
图177是图175的端部执行器的剖视图,其示出了处于至少部分击发状态的图176的钉以及处于至少部分刺穿状态的容器;177 is a cross-sectional view of the end effector of FIG. 175 showing the staple of FIG. 176 in an at least partially fired condition and the container in an at least partially pierced condition;
图178是根据至少一个实施例的包括砧座和钉仓的缝合器械的端部执行器的透视图;Figure 178 is a perspective view of an end effector of a stapling instrument including an anvil and a staple cartridge in accordance with at least one embodiment;
图179是图178的端部执行器的剖视图,其示出了定位在钉仓内的处于未击发状态的钉以及定位在钉仓的组织厚度补偿件内的处于未刺穿状态的密封容器,其中为了说明的目的,容器被示为其部分被移除;179 is a cross-sectional view of the end effector of FIG. 178 showing staples positioned within a staple cartridge in an unfired condition and a sealed container positioned within a tissue thickness compensator of the staple cartridge in an unpunctured condition, wherein the container is shown with parts removed for illustrative purposes;
图180是图178的端部执行器的剖视图,其示出了处于至少部分击发状态的图179的钉以及钉仓中的处于至少部分刺穿状态的容器;Fig. 180 is a cross-sectional view of the end effector of Fig. 178 showing the staple of Fig. 179 in an at least partially fired state and a container in the staple cartridge in an at least partially pierced state;
图181是根据至少一个另选的实施例的包括砧座和附接到砧座的密封容器的缝合器械的端部执行器的透视图,其中为了说明的目的,容器被示为其部分被移除;181 is a perspective view of an end effector of a suturing instrument including an anvil and a sealed container attached to the anvil, wherein the container is shown partially removed for purposes of illustration, according to at least one alternative embodiment. remove;
图182是图181的端部执行器的剖视图,其示出了至少部分地从钉仓击发的钉以及附接到砧座的处于至少部分刺穿状态的容器;182 is a cross-sectional view of the end effector of FIG. 181 showing the staples at least partially fired from the staple cartridge and the container attached to the anvil in an at least partially pierced state;
图183是附接到以膨胀状态示出的图181的砧座的容器的剖视图;Figure 183 is a cross-sectional view of the container attached to the anvil of Figure 181 shown in an expanded state;
图184是附接到以膨胀状态示出的图183的砧座的容器的细部图;Figure 184 is a detail view of the container attached to the anvil of Figure 183 shown in an expanded state;
图185示出了在横向于钉线的方向上延伸的容器;Figure 185 shows a container extending in a direction transverse to the staple line;
图186示出了在横向于钉线的方向上延伸的多个容器;Figure 186 shows a plurality of containers extending in a direction transverse to the staple line;
图187是根据各种实施例的钉仓的剖视图;Figure 187 is a cross-sectional view of a staple cartridge according to various embodiments;
图188是处于植入条件下的图187的局部剖视图;Figure 188 is a partial cross-sectional view of Figure 187 in an implanted condition;
图189A是组织厚度补偿件在膨胀之前的局部透视图;Figure 189A is a partial perspective view of a tissue thickness compensator prior to expansion;
图189B是图189的组织厚度补偿件在膨胀期间的局部透视图;Figure 189B is a partial perspective view of the tissue thickness compensator of Figure 189 during expansion;
图190是根据各种实施例的包含流体溶胀性组合物的组织厚度补偿件的局部透视图;Figure 190 is a partial perspective view of a tissue thickness compensator comprising a fluid-swellable composition, according to various embodiments;
图191是根据各种实施例的被定位成与组织厚度补偿件相邻的组织的剖视图;Figure 191 is a cross-sectional view of tissue positioned adjacent a tissue thickness compensator, according to various embodiments;
图192是在钉仓已被击发后的图191的局部剖视图;Figure 192 is a partial cross-sectional view of Figure 191 after the staple cartridge has been fired;
图193是示出与组织相邻植入的图191的组织厚度补偿件的示意图;193 is a schematic diagram showing the tissue thickness compensator of FIG. 191 implanted adjacent to tissue;
图194是根据各种实施例的组织厚度补偿件的局部透视图;Figure 194 is a partial perspective view of a tissue thickness compensator according to various embodiments;
图195是能够接收图194的组织厚度补偿件的钳口的透视图;Figure 195 is a perspective view of jaws capable of receiving the tissue thickness compensator of Figure 194;
图196是钉仓的局部剖视图,其示出了从钉仓部署的钉;196 is a partial cross-sectional view of a staple cartridge showing staples deployed from the staple cartridge;
图197是定位在一次性加载单元的执行器内的上部组织厚度补偿件和下部组织厚度补偿件的透视图;197 is a perspective view of an upper tissue thickness compensator and a lower tissue thickness compensator positioned within an actuator of a disposable loading unit;
图198A是根据各种实施例的在模具中制造的图197的下部组织厚度补偿件的剖视图;198A is a cross-sectional view of the lower tissue thickness compensator of FIG. 197 fabricated in a mold, according to various embodiments;
图198B是根据各种实施例的在模具中制造的三层组织厚度补偿件的剖视图;Figure 198B is a cross-sectional view of a three-layer tissue thickness compensator fabricated in a mold, according to various embodiments;
图199是根据各种实施例的砧座的剖视图,该砧座包括包含增强材料的组织厚度补偿件;Figure 199 is a cross-sectional view of an anvil comprising a tissue thickness compensator comprising reinforcing material, according to various embodiments;
图200是根据各种实施例的组织的剖视图,该组织定位在上部组织厚度补偿件与下部组织厚度补偿件中间;Figure 200 is a cross-sectional view of tissue positioned intermediate an upper tissue thickness compensator and a lower tissue thickness compensator, according to various embodiments;
图201是图200的剖视图,其示出了从钉仓部署的钉;Figure 201 is a cross-sectional view of Figure 200 showing the staples deployed from the staple cartridge;
图202是在钉仓已被击发后图200的剖视图;Figure 202 is a cross-sectional view of Figure 200 after the staple cartridge has been fired;
图203A示出了根据各种实施例的针,该针能够将流体递送至附接到钉仓的组织厚度补偿件;Figure 203A illustrates a needle capable of delivering fluid to a tissue thickness compensator attached to a staple cartridge, according to various embodiments;
图203B是包括组织厚度补偿件的钉仓的剖视图,该组织厚度补偿件能够接收图203A的针;203B is a cross-sectional view of a staple cartridge including a tissue thickness compensator capable of receiving the needle of FIG. 203A;
图204示出了根据各种实施例的制造组织厚度补偿件的方法;Figure 204 illustrates a method of manufacturing a tissue thickness compensator according to various embodiments;
图205是根据各种实施例的形成膨胀的厚度补偿件的示意图和方法;Figure 205 is a schematic diagram and method of forming an expanded thickness compensator according to various embodiments;
图206示出了包含水凝胶前体的胶束;以及Figure 206 shows micelles comprising hydrogel precursors; and
图207是根据各种实施例的外科器械的示意图,该外科器械包括组织厚度补偿件以及可递送至组织厚度补偿件的流体;207 is a schematic illustration of a surgical instrument comprising a tissue thickness compensator and a fluid deliverable to the tissue thickness compensator, according to various embodiments;
图208是根据至少一个实施例的组织厚度补偿件的局部透视图,该组织厚度补偿件固定到外科器械的端部执行器的砧座。208 is a partial perspective view of a tissue thickness compensator secured to an anvil of an end effector of a surgical instrument in accordance with at least one embodiment.
图209是图208的组织厚度补偿件的管状元件的透视图。209 is a perspective view of a tubular element of the tissue thickness compensator of FIG. 208. FIG.
图210是图209的管状元件的透视图,其示出了被切为两半并且在每一半内使亲水性物质流体接触的管状元件。Figure 210 is a perspective view of the tubular element of Figure 209 showing the tubular element cut in half and having a hydrophilic substance in fluid contact within each half.
图211是图210的切断管状元件的一半的透视图,其示出了切断管状元件的膨胀。Figure 211 is a perspective view of one half of the severed tubular element of Figure 210 showing expansion of the severed tubular element.
贯穿多个视图,对应的参考符号指示对应的部件。本文示出的范例以一种形式示出了本发明的某些实施例,并且不应将此类范例理解为以任何方式限制本发明的范围。Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set forth herein illustrate certain embodiments of the invention in one form, and such exemplifications should not be construed as limiting the scope of the invention in any way.
具体实施方式detailed description
本申请的申请人还拥有以下的美国专利申请,这些专利申请以引用的方式各自完全并入本文:The applicant of the present application also owns the following U.S. patent applications, each of which is fully incorporated herein by reference:
名称为“SURGICAL INSTRUMENTS WITH RECONFIGURABLE SHAFT SEGMENTS”的美国专利申请序列号12/894,311(代理人案卷号END6734USNP/100058);U.S. Patent Application Serial No. 12/894,311, entitled "SURGICAL INSTRUMENTS WITH RECONFIGURABLE SHAFT SEGMENTS" (Attorney Docket No. END6734USNP/100058);
名称为“SURGICAL STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGEDSTAPLES AND SURGICAL STAPLING INSTRUMENTS WITH COMMON STAPLE-FORMING POCKETS”的美国专利申请序列号12/894,340(代理人案卷号END6735USNP/100059);U.S. Patent Application Serial No. 12/894,340 (Attorney Docket No. END6735USNP/100059), entitled "SURGICAL STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGEDSTAPLES AND SURGICAL STAPLING INSTRUMENTS WITH COMMON STAPLE-FORMING POCKETS";
名称为“JAW CLOSURE ARRANGEMENTS FOR SURGICAL INSTRUMENTS”的美国专利申请序列号12/894,327(代理人案卷号END6736USNP/100060);U.S. Patent Application Serial No. 12/894,327, entitled "JAW CLOSURE ARRANGEMENTS FOR SURGICAL INSTRUMENTS" (Attorney Docket No. END6736USNP/100060);
名称为“SURGICAL CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE ANDDISTINCT FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS”的美国专利申请序列号12/894,351(代理人案卷号END6839USNP/100524);U.S. Patent Application Serial No. 12/894,351, entitled "SURGICAL CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE ANDDISTINCT FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS" (Attorney Docket No. END6839USNP/100524);
名称为“IMPLANTABLE FASTENER CARTRIDGE HAVING A NON-UNIFORMARRANGEMENT”的美国专利申请序列号12/894,338(代理人案卷号END6840USNP/100525);U.S. Patent Application Serial No. 12/894,338, entitled "IMPLANTABLE FASTENER CARTRIDGE HAVING A NON-UNIFOR MARRANGEMENT" (Attorney Docket No. END6840USNP/100525);
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISING A SUPPORT RETAINER”的美国专利申请序列号12/894,369(代理人案卷号END6841USNP/100526);U.S. Patent Application Serial No. 12/894,369, entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING A SUPPORT RETAINER" (Attorney Docket No. END6841USNP/100526);
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS”的美国专利申请序列号12/894,312(代理人案卷号END6842USNP/100527);U.S. Patent Application Serial No. 12/894,312, entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS" (Attorney Docket No. END6842USNP/100527);
名称为“SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE”的美国专利申请序列号12/894,377(代理人案卷号END6843USNP/100528);U.S. Patent Application Serial No. 12/894,377, entitled "SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE" (Attorney Docket No. END6843USNP/100528);
名称为“SURGICAL STAPLING INSTRUMENT WITH COMPACT ARTICULATION CONTROLARRANGEMENT”的美国专利申请序列号12/894,339(代理人案卷号END6847USNP/100532);U.S. Patent Application Serial No. 12/894,339 (Attorney Docket No. END6847USNP/100532), entitled "SURGICAL STAPLING INSTRUMENT WITH COMPACT ARTICULATION CONTROLARRANGEMENT";
名称为“SURGICAL STAPLING INSTRUMENT WITH A VARIABLE STAPLE FORMINGSYSTEM”的美国专利申请序列号12/894,360(代理人案卷号END6848USNP/100533);U.S. Patent Application Serial No. 12/894,360 (Attorney Docket No. END6848USNP/100533) entitled "SURGICAL STAPLING INSTRUMENT WITH A VARIABLE STAPLE FORMING SYSTEM";
名称为“SURGICAL STAPLING INSTRUMENT WITH INTERCHANGEABLE STAPLECARTRIDGE ARRANGEMENTS”的美国专利申请序列号12/894,322(代理人案卷号END6849USNP/100534);U.S. Patent Application Serial No. 12/894,322, entitled "SURGICAL STAPLING INSTRUMENT WITH INTERCHANGEABLE STAPLECARTRIDGE ARRANGEMENTS" (Attorney Docket No. END6849USNP/100534);
名称为“SURGICAL STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURESAND SURGICAL STAPLING INSTRUMENTS WITH SYSTEMS FOR PREVENTING ACTUATIONMOTIONS WHEN A CARTRIDGE IS NOT PRESENT”的美国专利申请序列号12/894,350(代理人案卷号END6855USNP/100540);U.S. Patent Application Serial No. 12/894,350, entitled "SURGICAL STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES AND SURGICAL STAPLING INSTRUMENTS WITH SYSTEMS FOR PREVENTING ACTUATIONMOTIONS WHEN A CARTRIDGE IS NOT PRESENT" (Attorney Docket No. END1855NP0/)
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISING BIOABSORBABLELAYERS”的美国专利申请序列号12/894,383(代理人案卷号END6856USNP/100541);U.S. Patent Application Serial No. 12/894,383 (Attorney Docket No. END6856USNP/100541), entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING BIOABSORBABLELAYERS";
名称为“COMPRESSIBLE FASTENER CARTRIDGE”的美国专利申请序列号12/894,389(代理人案卷号END6857USNP/100542);U.S. Patent Application Serial No. 12/894,389, entitled "COMPRESSIBLE FASTENER CARTRIDGE" (Attorney Docket No. END6857USNP/100542);
名称为“FASTENERS SUPPORTED BY A FASTENER CARTRIDGE SUPPORT”的美国专利申请序列号12/894,345(代理人案卷号END6858USNP/100543);U.S. Patent Application Serial No. 12/894,345, entitled "FASTENERS SUPPORTED BY A FASTENER CARTRIDGE SUPPORT" (Attorney Docket No. END6858USNP/100543);
名称为“COLLAPSIBLE FASTENER CARTRIDGE”的美国专利申请序列号12/894,306(代理人案卷号END6859USNP/100544);U.S. Patent Application Serial No. 12/894,306 (Attorney Docket No. END6859USNP/100544) entitled "COLLAPSIBLE FASTENER CARTRIDGE";
名称为“FASTENER SYSTEM COMPRISING A PLURALITY OF CONNECTED RETENTIONMATRIX ELEMENTS”的美国专利申请序列号12/894,318(代理人案卷号END6860USNP/100546);U.S. Patent Application Serial No. 12/894,318, entitled "FASTENER SYSTEM COMPRISING A PLURALITY OF CONNECTED RETENTIONMATRIX ELEMENTS" (Attorney Docket No. END6860USNP/100546);
名称为“FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENTMATRIX”的美国专利申请序列号12/894,330(代理人案卷号END6861USNP/100547);U.S. Patent Application Serial No. 12/894,330, entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENTMATRIX" (Attorney Docket No. END6861USNP/100547);
名称为“FASTENER SYSTEM COMPRISING A RETENTION MATRIX”的美国专利申请序列号12/894,361(代理人案卷号END6862USNP/100548);U.S. Patent Application Serial No. 12/894,361, entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX" (Attorney Docket No. END6862USNP/100548);
名称为“FASTENING INSTRUMENT FOR DEPLOYING A FASTENER SYSTEMCOMPRISING A RETENTION MATRIX”的美国专利申请序列号12/894,367(代理人案卷号END6863USNP/100549);U.S. Patent Application Serial No. 12/894,367, entitled "FASTENING INSTRUMENT FOR DEPLOYING A FASTENER SYSTEMCOMPRISING A RETENTION MATRIX" (Attorney Docket No. END6863USNP/100549);
名称为“FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND A COVER”的美国专利申请序列号12/894,388(代理人案卷号END6864USNP/100550);U.S. Patent Application Serial No. 12/894,388, entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND A COVER" (Attorney Docket No. END6864USNP/100550);
名称为“FASTENER SYSTEM COMPRISING A PLURALITY OF FASTENER CARTRIDGES”的美国专利申请序列号12/894,376(代理人案卷号END6865USNP/100551);U.S. Patent Application Serial No. 12/894,376, entitled "FASTENER SYSTEM COMPRISING A PLURALITY OF FASTENER CARTRIDGES" (Attorney Docket No. END6865USNP/100551);
名称为“SURGICAL STAPLER ANVIL COMPRISING A PLURALITY OF FORMINGPOCKETS”的美国专利申请序列号13/097,865(代理人案卷号END6735USCIP1/100059CIP1);U.S. Patent Application Serial No. 13/097,865 (Attorney Docket No. END6735USCIP1/100059CIP1) entitled "SURGICAL STAPLER ANVIL COMPRISING A PLURALITY OF FORMINGPOCKETS";
名称为“TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER”的美国专利申请序列号13/097,936(代理人案卷号END6736USCIP1/100060CIP1);U.S. Patent Application Serial No. 13/097,936 (Attorney Docket No. END6736USCIP1/100060CIP1) entitled "TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER";
名称为“STAPLE CARTRIDGE COMPRISING A VARIABLE THICKNESS COMPRESSIBLEPORTION”的美国专利申请序列号13/097,954(代理人案卷号END6840USCIP1/100525CIP1);U.S. Patent Application Serial No. 13/097,954 (Attorney Docket No. END6840USCIP1/100525CIP1) entitled "STAPLE CARTRIDGE COMPRISING A VARIABLE THICKNESS COMPRESSIBLEPORTION";
名称为“STAPLE CARTRIDGE COMPRISING STAPLES POSITIONED WITHIN ACOMPRESSIBLE PORTION THEREOF”的美国专利申请序列号13/097,856(代理人案卷号END6841USCIP1/100526CIP1);U.S. Patent Application Serial No. 13/097,856 (Attorney Docket No. END6841USCIP1/100526CIP1) entitled "STAPLE CARTRIDGE COMPRISING STAPLES POSITIONED WITHIN ACOMPRESSIBLE PORTTION THEREOF";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING DETACHABLE PORTIONS”的美国专利申请序列号13/097,928(代理人案卷号END6842USCIP1/100527CIP1);U.S. Patent Application Serial No. 13/097,928 (Attorney Docket No. END6842USCIP1/100527CIP1) entitled "TISSUE THICKNESS COMPENSATOR COMPRISING DETACHABLE PORTIONS";
名称为“TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER COMPRISINGAN ADJUSTABLE ANVIL”的美国专利申请序列号13/097,891(代理人案卷号END6843USCIP1/100528CIP1);U.S. Patent Application Serial No. 13/097,891 (Attorney Docket No. END6843USCIP1/100528CIP1) entitled "TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER COMPRISINGAN ADJUSTABLE ANVIL";
名称为“STAPLE CARTRIDGE COMPRISING AN ADJUSTABLE DISTAL PORTION”的美国专利申请序列号13/097,948(代理人案卷号END6847USCIP1/100532CIP1);U.S. Patent Application Serial No. 13/097,948, entitled "STAPLE CARTRIDGE COMPRISING AN ADJUSTABLE DISTAL PORTION" (Attorney Docket No. END6847USCIP1/100532CIP1);
名称为“COMPRESSIBLE STAPLE CARTRIDGE ASSEMBLY”的美国专利申请序列号13/097,907(代理人案卷号END6848USCIP1/100533CIP1);U.S. Patent Application Serial No. 13/097,907 (Attorney Docket No. END6848USCIP1/100533CIP1), entitled "COMPRESSIBLE STAPLE CARTRIDGE ASSEMBLY";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING PORTIONS HAVINGDIFFERENT PROPERTIES”的美国专利申请序列号13/097,861(代理人案卷号END6849USCIP1/100534CIP1);U.S. Patent Application Serial No. 13/097,861 (Attorney Docket No. END6849USCIP1/100534CIP1) entitled "TISSUE THICKNESS COMPENSATOR COMPRISING PORTIONS HAVING DIFFERENT PROPERTIES";
名称为“STAPLE CARTRIDGE LOADING ASSEMBLY”的美国专利申请序列号13/097,869(代理人案卷号END6855USCIP1/100540CIP1);U.S. Patent Application Serial No. 13/097,869 (Attorney Docket No. END6855USCIP1/100540CIP1) entitled "STAPLE CARTRIDGE LOADING ASSEMBLY";
名称为“COMPRESSIBLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS”的美国专利申请序列号13/097,917(代理人案卷号END6856USCIP1/100541CIP1);U.S. Patent Application Serial No. 13/097,917, entitled "COMPRESSIBLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS" (Attorney Docket No. END6856USCIP1/100541CIP1);
名称为“STAPLE CARTRIDGE COMPRISING A RELEASABLE PORTION”的美国专利申请序列号13/097,873(代理人案卷号END6857USCIP1/100542CIP1);U.S. Patent Application Serial No. 13/097,873, entitled "STAPLE CARTRIDGE COMPRISING A RELEASABLE PORTION" (Attorney Docket No. END6857USCIP1/100542CIP1);
名称为“STAPLE CARTRIDGE COMPRISING COMPRESSIBLE DISTORTION RESISTANTCOMPONENTS”的美国专利申请序列号13/097,938(代理人案卷号END6858USCIP1/100543CIP1);U.S. Patent Application Serial No. 13/097,938 (Attorney Docket No. END6858USCIP1/100543CIP1) entitled "STAPLE CARTRIDGE COMPRISING COMPRESSIBLE DISTORTION RESISTANT COMPONENTS";
名称为“STAPLE CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR”的美国专利申请序列号13/097,924(代理人案卷号END6859USCIP1/100544CIP1);U.S. Patent Application Serial No. 13/097,924 (Attorney Docket No. END6859USCIP1/100544CIP1) entitled "STAPLE CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR";
名称为“SURGICAL STAPLER WITH FLOATING ANVIL”的美国专利申请序列号13/242,029(代理人案卷号END6841USCIP2/100526CIP2);U.S. Patent Application Serial No. 13/242,029 (Attorney Docket No. END6841USCIP2/100526CIP2) entitled "SURGICAL STAPLER WITH FLOATING ANVIL";
名称为“CURVED END EFFECTOR FOR A STAPLING INSTRUMENT”的美国专利申请序列号13/242,066(代理人案卷号END6841USCIP3/100526CIP3);U.S. Patent Application Serial No. 13/242,066, entitled "CURVED END EFFECTOR FOR A STAPLING INSTRUMENT" (Attorney Docket No. END6841USCIP3/100526CIP3);
名称为“STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK”的美国专利申请序列号13/242,086(代理人案卷号END7020USNP/110374);U.S. Patent Application Serial No. 13/242,086 (Attorney Docket No. END7020USNP/110374), entitled "STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK";
名称为“STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGEMENT”的美国专利申请序列号13/241,912(代理人案卷号END7019USNP/110375);U.S. Patent Application Serial No. 13/241,912 (Attorney Docket No. END7019USNP/110375), entitled "STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGEMENT";
名称为“SURGICAL STAPLER WITH STATIONARY STAPLE DRIVERS”的美国专利申请序列号13/241,922(代理人案卷号END7013USNP/110377);U.S. Patent Application Serial No. 13/241,922, entitled "SURGICAL STAPLER WITH STATIONARY STAPLE DRIVERS" (Attorney Docket No. END7013USNP/110377);
名称为“SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATINGMULTIPLE ACTUATION MOTIONS”的美国专利申请序列号13/241,637(代理人案卷号END6888USNP3/110378);以及U.S. Patent Application Serial No. 13/241,637 (Attorney Docket No. END6888USNP3/110378), entitled "SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATING MULTIPLE ACTUATION MOTIONS"; and
名称为“SURGICAL INSTRUMENT WITH SELECTIVELY ARTICULATABLE ENDEFFECTOR”的美国专利申请序列号13/241,629(代理人案卷号END6888USNP2/110379)。US Patent Application Serial No. 13/241,629 (Attorney Docket No. END6888USNP2/110379) entitled "SURGICAL INSTRUMENT WITH SELECTIVELY ARTICULATABLE ENDEFFECTOR."
本申请的申请人还拥有以下的美国专利申请,这些专利申请与本申请同一天提交,并且每个专利申请均全文引入本文以供参考:The applicant of the present application also owns the following U.S. patent applications, which were filed on the same date as this application, each of which is incorporated herein by reference in its entirety:
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OFCAPSULES”的美国专利申请序列号_______________(代理人案卷号END6864USCIP1/100550CIP1);US Patent Application Serial No. _______________ (Attorney Docket No. END6864USCIP1/100550CIP1) entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OFCAPSULES";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF LAYERS”的美国专利申请序列号_______________(代理人案卷号END6864USCIP2/100550CIP2);U.S. Patent Application Serial No. _______________ (Attorney Docket No. END6864USCIP2/100550CIP2) entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF LAYERS";
名称为“EXPANDABLE TISSUE THICKNESS COMPENSATOR”的美国专利申请序列号_______________(代理人卷号END6843USCIP2/100528CIP2)。US Patent Application Serial No. _______________ (Attorney Docket END6843USCIP2/100528CIP2) entitled "EXPANDABLE TISSUE THICKNESS COMPENSATOR."
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING A RESERVOIR”的美国专利申请序列号_______________(代理人案卷号END6843USCIP3/100528CIP3);US Patent Application Serial No. _______________ (Attorney Docket No. END6843USCIP3/100528CIP3) entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A RESERVOIR";
名称为“RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESS COMPENSATOR”的美国专利申请序列号_______________(代理人案卷号END6843USCIP4/100528CIP4);US Patent Application Serial No. _______________ (Attorney Docket No. END6843USCIP4/100528CIP4) entitled "RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESS COMPENSATOR";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING ATLEAST ONEMEDICAMENT”的美国专利申请序列号_______________(代理人案卷号END6843USCIP5/100528CIP5);U.S. Patent Application Serial No. _______________ (Attorney Docket No. END6843USCIP5/100528CIP5) entitled "TISSUE THICKNESS COMPENSATOR COMPRISING ATLEAST ONEMEDICAMENT";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING FIBERS TO PRODUCE ARESILIENT LOAD”的美国专利申请序列号_______________(代理人案卷号END6843USCIP7/100528CIP7);U.S. Patent Application Serial No. _______________ entitled "TISSUE THICKNESS COMPENSATOR COMPRISING FIBERS TO PRODUCE ARESILIENT LOAD" (Attorney Docket No. END6843USCIP7/100528CIP7);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING STRUCTURE TO PRODUCE ARESILIENT LOAD”的美国专利申请序列号_______________(代理人案卷号END6843USCIP8/100528CIP8);U.S. Patent Application Serial No. _______________ (Attorney Docket No. END6843USCIP8/100528CIP8) entitled "TISSUE THICKNESS COMPENSATOR COMPRISING STRUCTURE TO PRODUCE ARESILIENT LOAD";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING RESILIENT MEMBERS”的美国专利申请序列号_______________(代理人案卷号END6843USCIP9/100528CIP9);U.S. Patent Application Serial No. _______________ (Attorney Docket No. END6843USCIP9/100528CIP9) entitled "TISSUE THICKNESS COMPENSATOR COMPRISING RESILIENT MEMBERS";
名称为“METHODS FOR FORMING TISSUE THICKNESS COMPENSATOR ARRANGEMENTSFOR SURGICAL STAPLERS”的美国专利申请序列号_______________(代理人案卷号END6843USCIP10/100528CP10);U.S. Patent Application Serial No. _______________ (Attorney Docket No. END6843USCIP10/100528CP10) entitled "METHODS FOR FORMING TISSUE THICKNESS COMPENSATOR ARRANGEMENTSFOR SURGICAL STAPLERS";
名称为“TISSUE THICKNESS COMPENSATORS”的美国专利申请序列号_______________(代理人案卷号END6843USCIP11/100528CP11);US Patent Application Serial No. _______________ (Attorney Docket No. END6843USCIP11/100528CP11) entitled "TISSUE THICKNESS COMPENSATORS";
名称为“LAYERED TISSUE THICKNESS COMPENSATOR”的美国专利申请序列号_______________(代理人案卷号END6843USCIP12/100528CP12);US Patent Application Serial No. _______________ (Attorney Docket No. END6843USCIP12/100528CP12) entitled "LAYERED TISSUE THICKNESS COMPENSATOR";
名称为“TISSUE THICKNESS COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS”的美国专利申请序列号_______________(代理人案卷号END6843USCIP13/100528CP13);US Patent Application Serial No. _______________ (Attorney Docket No. END6843USCIP13/100528CP13) entitled "TISSUE THICKNESS COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING CAPSULES DEFINING ALOW PRESSURE ENVIRONMENT”的美国专利申请序列号_______________(代理人案卷号END7100USNP/110601);U.S. Patent Application Serial No. _______________ (Attorney Docket No. END7100USNP/110601) entitled "TISSUE THICKNESS COMPENSATOR COMPRISING CAPSULES DEFINING ALOW PRESSURE ENVIRONMENT";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISED OF A PLURALITY OFMATERIALS”的美国专利申请序列号_______________(代理人案卷号END7101USNP/110602);U.S. Patent Application Serial No. _______________ (Attorney Docket No. END7101USNP/110602) entitled "TISSUE THICKNESS COMPENSATOR COMPRISED OF A PLURALITY OFMATERIALS";
名称为“MOVABLE MEMBER FOR USE WITH A TISSUE THICKNESS COMPENSATOR”的美国专利申请序列号_______________(代理人案卷号END7107USNP/110603);U.S. Patent Application Serial No. _______________ entitled "MOVABLE MEMBER FOR USE WITH A TISSUE THICKNESS COMPENSATOR" (Attorney Docket No. END7107USNP/110603);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OFMEDICAMENTS”的美国专利申请序列号_______________(代理人案卷号END7102USNP/110604);U.S. Patent Application Serial No. _______________, entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OFMEDICAMENTS" (Attorney Docket No. END7102USNP/110604);
名称为“TISSUE THICKNESS COMPENSATOR AND METHOD FOR MAKING THE SAME”的美国专利申请序列号_______________(代理人案卷号END7103USNP/110605);US Patent Application Serial No. _______________ (Attorney Docket No. END7103USNP/110605) entitled "TISSUE THICKNESS COMPENSATOR AND METHOD FOR MAKING THE SAME";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING CHANNELS”的美国专利申请序列号_______________(代理人案卷号END7104USNP/110606);US Patent Application Serial No. _______________ (Attorney Docket No. END7104USNP/110606) entitled "TISSUE THICKNESS COMPENSATOR COMPRISING CHANNELS";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING TISSUE INGROWTHFEATURES”的美国专利申请序列号_______________(代理人案卷号END7105USNP/110607);以及U.S. Patent Application Serial No. _______________, entitled "TISSUE THICKNESS COMPENSATOR COMPRISING TISSUE INGROWTHFEATURES" (Attorney Docket No. END7105USNP/110607); and
名称为“DEVICES AND METHODS FOR ATTACHING TISSUE THICKNESSCOMPENSATING MATERIALS TO SURGICAL STAPLING INSTRUMENTS”的美国专利申请序列号_______________(代理人案卷号END7106USNP/110608)。U.S. Patent Application Serial No. _______________ (Attorney Docket No. END7106USNP/110608) entitled "DEVICES AND METHODS FOR ATTACHING TISSUE THICKNESSCOMPENSATING MATERIALS TO SURGICAL STAPLING INSTRUMENTS."
现在将描述某些示例性实施例,以从整体上理解本文所公开的装置和方法的结构、功能、制造和用途。这些实施例的一个或多个实例在附图中示出。本领域的普通技术人员应当理解,本文具体描述并且示出于附图中的装置和方法均为非限制的示例性实施例。就一个示例性实施例进行图解说明或描述的特征,可与其他实施例的特征进行组合。此类修改和变型包括在本发明的范围内。Certain exemplary embodiments will now be described to provide an overall understanding of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art should understand that the devices and methods specifically described herein and shown in the accompanying drawings are non-limiting exemplary embodiments. Features illustrated or described with respect to one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are included within the scope of the present invention.
可采用本文所公开或受权利要求书保护的用于制造、形成或以其他的方式生产制品或产品的方法中的任何一者来制造、形成或以其他的方式生产所考虑的制品或产品的全部或部分,并且在采用此类方法制造、形成或以其他的方式生产所考虑的制品或产品的部分的情况下,可以任何方式生产制品或产品的其余部分,包括通过采用本文所公开和受权利要求书保护的用于制造、形成或以其他的方式生产制品或产品的其他方法中的任何一者,并且可以任何方式组合如此生产的各个部分。相似地,本文所公开或受权利要求书保护的任何制品或产品均可单独存在,或与如此公开的与其相容的任何其他制品或产品结合存在或作为其整体部分存在。因此,可将结合一种制品、产品或方法所示或所述的特定特征、结构或特性全部或部分与一种或多种其他相容制品、产品或方法的特征或特性无限制地组合。此类修改和变型包括在本发明的范围内。The article or product under consideration may be manufactured, formed or otherwise produced by any of the methods disclosed or claimed herein for making, forming or otherwise producing the article or product in whole or in part, and where such methods are used to manufacture, form or otherwise produce a portion of the article or product under consideration, the remainder of the article or product may be produced in any way, including by employing the Any of the other methods of making, forming, or otherwise producing an article or product claimed, and the parts so produced may be combined in any way. Similarly, any article or product disclosed or claimed herein may exist alone, in combination with or as an integral part of any other article or product so disclosed or with which it is compatible. Thus, a particular feature, structure or characteristic shown or described in connection with one article, product or method may be combined in whole or in part with one or more features or characteristics of another compatible article, product or method without limitation. Such modifications and variations are included within the scope of the present invention.
参照特定附图或以其他方式,在本文所公开的本发明的特定实施例或者某些制品、产品或方法可包括某些结构、特性或特征的情况下,读者应当理解,这表示那些结构、特性或特征结构可以任何相容组合体现在所考虑的制品、产品或方法中。具体地讲,多个任选结构、特性或特征的此类公开内容应当理解为另外以组合形式公开所有那些结构、特性或特征,但作为彼此另选形式所公开的结构、特性或特征的情况除外。在此类结构、特性或特征作为彼此另选形式所公开的情况下,这应当理解为将那些另选形式公开作为用于彼此的替换。Where particular embodiments of the invention disclosed herein, or certain articles, products, or methods, may include certain structures, features or characteristics, with reference to particular drawings or otherwise, the reader should understand that it is meant to represent those structures, The properties or characteristics may be embodied in any compatible combination in the contemplated article, product or method. In particular, such disclosure of a plurality of optional structures, properties or features should be understood as the case where all of those structures, properties or features are additionally disclosed in combination, but as alternatives to each other. except. Where such structures, properties or characteristics are disclosed as alternatives to one another, it should be understood that those alternatives are disclosed as replacements for each other.
本文所用术语“近侧”和“远侧”是相对于操纵外科器械的柄部部分的临床医生而言的。术语“近侧”是指最靠近临床医生的部分,术语“远侧”是指远离临床医生的部分。还应当理解,为简洁和清楚起见,本文可以结合附图使用诸如“竖直”、“水平”、“上”和“下”之类的空间术语。然而,外科器械在许多方向和位置中使用,并且这些术语并非限制性的和/或绝对的。The terms "proximal" and "distal" are used herein with respect to a clinician manipulating the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion remote from the clinician. It should also be understood that spatial terms such as "vertical," "horizontal," "upper," and "lower" may be used herein in connection with the drawings for the sake of brevity and clarity. However, surgical instruments are used in many orientations and positions, and these terms are not limiting and/or absolute.
提供了各种示例性装置和方法以执行腹腔镜式和微创外科手术操作。然而,读者将易于理解,本文所公开的各种方法和装置可用于许多外科手术操作和应用(包括与开放式外科手术操作相结合的应用)中。继续参阅本具体实施方式,读者将进一步理解,本文所公开的各种器械可以任何方式插入体内,诸如通过自然腔道、通过形成于组织中的切口或穿刺孔等。器械的工作部分或端部执行器部分可被直接插入患者体内或可通过具有工作通道的进入装置而插入,外科器械的端部执行器和细长轴可通过所述工作通道而推进。Various exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, the reader will readily appreciate that the various methods and devices disclosed herein can be used in many surgical procedures and applications, including applications in conjunction with open surgical procedures. Continuing to read the detailed description, the reader will further understand that the various devices disclosed herein can be inserted into the body in any way, such as through a natural orifice, through an incision or a puncture hole formed in a tissue, and the like. The working or end effector portion of the instrument may be inserted directly into the patient or may be inserted through an access device having a working channel through which the end effector and elongated shaft of the surgical instrument may be advanced.
转到附图,其中在多个视图中,类似的数字表示类似的组件,图1示出了能够实践若干独特益处的外科器械10。外科缝合器械10被设计成用于操纵和/或致动可操作地附接到外科缝合器械10的各种形式及尺寸的端部执行器12。在图1-图1E中,例如端部执行器12包括细长通道14,该细长通道形成端部执行器12的下钳口13。细长通道14能够支撑“可植入的”钉仓30并且还可动地支撑用作端部执行器12的上钳口15的砧座20。Turning to the drawings, wherein like numerals represent like components throughout the several views, FIG. 1 illustrates a surgical instrument 10 that enables several unique benefits to be practiced. The surgical stapling instrument 10 is designed to manipulate and/or actuate various forms and sizes of end effectors 12 operably attached to the surgical stapling instrument 10 . In FIGS. 1-1E , for example, the end effector 12 includes an elongated channel 14 forming a lower jaw 13 of the end effector 12 . The elongated channel 14 is capable of supporting an “implantable” staple cartridge 30 and also movably supports an anvil 20 that serves as the upper jaw 15 of the end effector 12 .
细长通道14可由例如300&400系列、17-4&17-7不锈钢、钛等制成,并可形成有间隔侧壁16。砧座20例如可由300&400系列17-4&17-7不锈钢、钛等加工而成,并可具有钉成形下表面,所述钉成形下表面总体被标示为22且其中形成有多个钉成形凹坑23。参见图1B-1E。另外,砧座20具有从砧座20向近侧突起的分为两部分的滑道组件24。砧座销26从滑道组件24的每一横侧突起,以接收在细长通道14的侧壁16中的对应狭槽或开口18中,从而有利于将砧座销26可动地或枢转地附接到所述对应狭槽或开口18。The elongated channel 14 may be made of, for example, 300 & 400 series, 17-4 & 17-7 stainless steel, titanium, etc., and may be formed with spacer sidewalls 16 . The anvil 20 may be machined, for example, from 300 & 400 series 17-4 & 17-7 stainless steel, titanium, etc., and may have a staple forming lower surface generally designated 22 and having a plurality of staple forming pockets 23 formed therein . See Figures 1B-1E. Additionally, the anvil 20 has a bifurcated slideway assembly 24 protruding proximally from the anvil 20 . Anvil pin 26 protrudes from each lateral side of slideway assembly 24 to be received in a corresponding slot or opening 18 in side wall 16 of elongate channel 14 to facilitate moving or pivoting anvil pin 26. Rotatingly attached to said corresponding slot or opening 18.
各种形式的植入式钉仓可与本文所公开的外科器械一起使用。以下将更详细地论述特定的钉仓构型和构造。然而,在图1A中,示出了植入式钉仓30。钉仓30具有主体部分31,该主体部分由可压缩的止血材料(诸如氧化再生纤维素(“ORC”)或可生物吸收的泡沫)构成,其中支撑有多行未成形的金属钉32。为防止钉受影响并且防止止血材料在引入和定位过程期间被活化,整个仓可涂覆有或包裹有可生物降解的膜38,诸如以商标出售的六环酮膜或聚甘油癸二酸酯(PGS)膜或由PGA(聚乙醇酸,以商标Vicryl出售)、PCL(聚己内酯)、PLA或PLLA(聚乳酸)、PHA(聚羟基链烷酸酯)、PGCL(聚卡普隆25,以商标Monocryl出售)或PGA、PCL、PLA、PDS的复合物形成的其他可生物降解的膜,所述膜只有在破裂时才可渗透。钉仓30的本体31的尺寸被设定成可移除地支撑在如图所示的细长通道14内,使得当砧座20被驱动至与钉仓30形成接触时,其中的每一钉32均与对应的钉成形凹坑23对齐。Various forms of implantable staple cartridges can be used with the surgical instruments disclosed herein. Specific staple cartridge configurations and configurations are discussed in more detail below. In FIG. 1A , however, an implantable staple cartridge 30 is shown. Staple cartridge 30 has a body portion 31 constructed of a compressible hemostatic material, such as oxidized regenerated cellulose ("ORC") or bioabsorbable foam, in which rows of unformed metal staples 32 are supported. To prevent the staples from being affected and to prevent the hemostatic material from being activated during the introduction and positioning process, the entire cartridge can be coated or wrapped with a biodegradable membrane 38, such as under the trademark Hexacyclic ketone membranes or polyglyceryl sebacate (PGS) membranes are sold or made of PGA (polyglycolic acid, sold under the trademark Vicryl), PCL (polycaprolactone), PLA or PLLA (polylactic acid), PHA (poly Hydroxyalkanoate), PGCL (polycapron 25, sold under the trademark Monocryl) or other biodegradable membranes formed from complexes of PGA, PCL, PLA, PDS which are only permeable when ruptured . The body 31 of the staple cartridge 30 is sized to be removably supported within the elongated channel 14 as shown so that when the anvil 20 is driven into contact with the staple cartridge 30, each staple therein 32 are each aligned with a corresponding staple forming pocket 23.
在使用中,一旦端部执行器12邻近靶组织定位,端部执行器12便被操纵以将靶组织捕获或夹紧在钉仓30的上表面36与砧座20的钉成形表面22之间。钉32通过如下方式成形:使砧座20在基本上平行于细长通道14的路径中运动,以使钉成形表面22且更具体地使其中的钉成形凹坑23基本上同时接触钉仓30的顶面36。随着砧座20继续移动至钉仓30中,钉32的腿部34在砧座20中接触对应的钉成形凹坑23,钉成形凹坑23用于使钉腿34弯曲以使钉32成形为“B形”。砧座20朝细长通道14的进一步运动将进一步压缩钉32并使其成形为期望的最终成形高度“FF”。In use, once the end effector 12 is positioned adjacent to the target tissue, the end effector 12 is manipulated to capture or clamp the target tissue between the upper surface 36 of the staple cartridge 30 and the staple forming surface 22 of the anvil 20 . The staples 32 are formed by moving the anvil 20 in a path substantially parallel to the elongated channel 14 so that the staple forming surfaces 22, and more specifically the staple forming pockets 23 therein, contact the staple cartridge 30 substantially simultaneously. 36 of the top surface. As the anvil 20 continues to move into the staple cartridge 30, the legs 34 of the staples 32 contact corresponding staple forming pockets 23 in the anvil 20 for bending the staple legs 34 to form the staples 32. For "B shape". Further movement of the anvil 20 toward the elongated channel 14 will further compress and form the staples 32 to the desired final formed height "FF".
上述钉成形过程大体描述于图1B-1E中。例如,图1B示出端部执行器12,其中靶组织“T”位于砧座20与可植入钉仓30的顶面36之间。图1C示出砧座20的初始夹紧位置,其中砧座20已被合拢至靶组织“T”上,以将靶组织“T”夹紧于砧座20与钉仓30的顶面36之间。图1D示出初始钉成形,其中砧座20已开始压缩钉仓30,使得钉32的腿部34开始通过砧座20中的钉成形凹坑23而成形。图1E示出穿过靶组织“T”而处于最终成形状态的钉32,为清晰起见已移除砧座20。一旦钉32成形并紧固至靶组织“T”,外科医生便使砧座20运动至打开位置,以在自患者撤出端部执行器12时使仓体31及钉32能够保持附连到靶组织。当两个钳口13、15共同夹紧时,端部执行器12使所有的钉同时成形。其余“被压溃的”本体材料31用作止血剂(ORC)及钉线增强剂(PGA、PDS、或任何上述其他膜组合物38)。此外,由于钉32在成形期间不必离开仓体31,因此钉32在成形期间变为畸形的可能性被最小化。如本文所用,术语“植入式”是指除钉之外,支撑钉的仓体材料也将被保持在患者体内并可最终被患者身体吸收。此类植入式钉仓区别于先前的钉仓结构,该先前的钉仓构造在其已被击发之后仍然完整地定位在端部执行器内。The staple forming process described above is generally depicted in Figures 1B-1E. For example, FIG. 1B shows end effector 12 with target tissue “T” positioned between anvil 20 and top surface 36 of implantable staple cartridge 30 . 1C shows the initial clamped position of the anvil 20, wherein the anvil 20 has been closed onto the target tissue "T" to clamp the target tissue "T" between the anvil 20 and the top surface 36 of the staple cartridge 30 between. FIG. 1D shows initial staple formation where the anvil 20 has begun to compress the staple cartridge 30 such that the legs 34 of the staples 32 begin to form through the staple forming pockets 23 in the anvil 20 . Figure IE shows staples 32 in their final formed state through target tissue "T" with anvil 20 removed for clarity. Once the staples 32 are formed and secured to the target tissue "T", the surgeon moves the anvil 20 to the open position to enable the cartridge body 31 and staples 32 to remain attached to the end effector 12 when withdrawing from the patient. target tissue. When the two jaws 13, 15 are clamped together, the end effector 12 forms all the staples simultaneously. The remaining "crushed" body material 31 acts as a hemostat (ORC) and staple line enhancer (PGA, PDS, or any of the other film compositions 38 described above). Furthermore, since the staples 32 do not have to exit the cartridge body 31 during forming, the likelihood of the staples 32 becoming misshapen during forming is minimized. As used herein, the term "implantable" means that in addition to the staples, the cartridge body material supporting the staples will also be retained within the patient's body and can eventually be absorbed by the patient's body. Such implantable staple cartridges are distinguished from previous staple cartridge configurations that remain fully positioned within the end effector after they have been fired.
在各种具体实施中,端部执行器12能够联接到从柄部组件100突起的细长轴组件40。端部执行器12(在闭合时)和伸长轴组件40可具有相似的横截面形状,并且其尺寸被设定成以另一种进入器械形式操作地穿过套管针管或工作通道。如本文所用,术语“可操作地穿过”是指端部执行器及细长轴组件的至少一部分可通过通道或管开口插入或可穿过通道或管开口,并可视需要在通道或管开口中对其进行操纵以完成外科缝合手术。当处于闭合位置时,端部执行器12的钳口13和15可为端部执行器提供大体圆形的横截面形状以利于其穿过圆形的通路/开口。然而,可设想本发明的端部执行器以及细长轴组件设有其他横截面形状,从而可以其他方式穿过具有非圆形横截面形状的进入通路和开口。因此,闭合的端部执行器的横截面的总体尺寸将与端部执行器将穿过的通道或开口的尺寸相关。因此,一个端部执行器例如可被称为“5mm”端部执行器,此是指其能够可操作地穿过直径至少为大约5mm的开口。In various implementations, the end effector 12 can be coupled to an elongated shaft assembly 40 protruding from the handle assembly 100 . The end effector 12 (when closed) and the elongated shaft assembly 40 may have similar cross-sectional shapes and be sized to operatively pass through a trocar tube or working channel as another access instrument. As used herein, the term "operably passed through" means that the end effector and at least a portion of the elongated shaft assembly can be inserted or passed through a channel or tube opening and optionally in the channel or tube opening. It is manipulated through the opening to complete the surgical closure. When in the closed position, the jaws 13 and 15 of the end effector 12 may provide the end effector with a generally circular cross-sectional shape to facilitate its passage through the circular passageway/opening. However, other cross-sectional shapes are contemplated for end effectors and elongated shaft assemblies of the present invention so that access passages and openings having non-circular cross-sectional shapes can be passed through in other ways. Thus, the overall size of the cross-section of the closed end effector will be related to the size of the channel or opening through which the end effector will pass. Thus, an end effector, for example, may be referred to as a "5 mm" end effector, meaning that it is capable of operatively passing through an opening that is at least about 5 mm in diameter.
细长轴组件40可具有与处于闭合位置的端部执行器12的外径基本相等的外径。例如,5mm端部执行器可联接到具有5mm横截面直径的细长轴组件40。然而,继续参阅本具体实施方式,将显而易见的是,本发明可有效地结合不同尺寸的端部执行器使用。例如,10mm端部执行器可附接到具有5mm横截面直径的细长轴。相反,对于其中提供10mm或更大的进入开口或通道的应用而言,细长轴组件40可具有10mm(或更大)的横截面直径,但也能够致动5mm或10mm端部执行器。因此,外轴40的外径可与附接到外轴40的闭合的端部执行器12的外径相同或不同。The elongated shaft assembly 40 may have an outer diameter substantially equal to the outer diameter of the end effector 12 in the closed position. For example, a 5 mm end effector may be coupled to an elongated shaft assembly 40 having a 5 mm cross-sectional diameter. However, with continued reference to the detailed description, it will become apparent that the present invention may be effectively used with end effectors of different sizes. For example, a 10mm end effector may be attached to an elongated shaft with a 5mm cross-sectional diameter. Conversely, for applications where an access opening or passageway of 10mm or greater is provided, the elongated shaft assembly 40 may have a cross-sectional diameter of 10mm (or greater), but is also capable of actuating a 5mm or 10mm end effector. Accordingly, the outer diameter of the outer shaft 40 may be the same as or different from the outer diameter of the closed end effector 12 attached to the outer shaft 40 .
如图所示,细长轴组件40从柄部组件100大体上沿着直线向远侧延伸,以限定纵向轴线A-A。例如,细长轴组件40可为约9-16英寸(229-406mm)长。然而,细长轴组件40可以其他长度提供,或者细长轴组件中可具有接头或以其他方式能够有利于端部执行器12相对于轴或柄部组件的其他部分进行关节运动,如下文将更详细地讨论。细长轴组件40包括脊构件50,该脊构件从柄部组件100延伸到端部执行器12。端部执行器12的细长通道14的近侧末端具有从其突起的一对保持耳轴17,该对保持耳轴的尺寸被设定成接收在脊构件50的远侧末端中所提供的对应的耳轴开口或支架52中,以使端部执行器12能够可移除地联接细长轴组件40。脊构件50可由例如6061或7075铝、不锈钢、钛等制成。As shown, elongated shaft assembly 40 extends distally from handle assembly 100 generally along a straight line to define longitudinal axis A-A. For example, the elongated shaft assembly 40 may be approximately 9-16 inches (229-406 mm) long. However, the elongated shaft assembly 40 may be provided in other lengths, or may have joints therein or otherwise be capable of facilitating articulation of the end effector 12 relative to the shaft or other portion of the handle assembly, as described below. discussed in more detail. Elongated shaft assembly 40 includes a spine member 50 that extends from handle assembly 100 to end effector 12 . The proximal end of the elongated channel 14 of the end effector 12 has a pair of retaining trunnions 17 projecting therefrom, the pair of retaining trunnions 17 being dimensioned to receive the trunnions provided in the distal end of the spine member 50. Corresponding trunnion openings or brackets 52 are provided to enable end effector 12 to be removably coupled to elongate shaft assembly 40 . Spine member 50 may be made of, for example, 6061 or 7075 aluminum, stainless steel, titanium, or the like.
柄部组件100包括手枪抓握型外壳,该手枪抓握型外壳可出于组装目的而被制成两个或更多个部分。例如,如图所示的柄部组件100包括由聚合物或塑性材料模塑或以其他的方式制成的、并被设计成配合在一起的右手壳体构件102和左手壳体构件(未示出)。可通过在其中模塑或以其他的方式形成的按扣特征结构、栓、和承窝、和/或通过粘合剂、螺钉等而将此类壳体构件附接到一起。脊构件50具有近侧末端54,在该近侧末端上形成有凸缘56。凸缘56能够被旋转地支撑在沟槽106中,该沟槽由从壳体构件102、104中的每一者向内突起的配合肋108形成。这种结构有利于脊构件50附接到柄部组件100,同时使脊构件50能够相对于柄部组件100沿360°路径绕纵向轴线A-A旋转。The handle assembly 100 includes a pistol grip type housing that may be made in two or more parts for assembly purposes. For example, the handle assembly 100 as shown includes a right-hand housing member 102 and a left-hand housing member (not shown) molded or otherwise made from a polymer or plastic material and designed to fit together. out). Such housing components may be attached together by snap features, pegs, and sockets molded or otherwise formed therein, and/or by adhesives, screws, and the like. The spine member 50 has a proximal end 54 on which a flange 56 is formed. The flange 56 is rotatably supported in a groove 106 formed by mating ribs 108 projecting inwardly from each of the housing members 102 , 104 . This configuration facilitates attachment of spine member 50 to handle assembly 100 while enabling spine member 50 to rotate relative to handle assembly 100 along a 360° path about longitudinal axis A-A.
如在图1中可进一步看出,脊构件50穿过安装轴衬60并由安装轴衬60支撑,该安装轴衬60可旋转地附连到柄部组件100。安装轴衬60具有近侧凸缘62和远侧凸缘64,该近侧凸缘和远侧凸缘限定旋转沟槽65,该旋转沟槽能够将柄部组件100的前缘部分101可旋转地接收在其间。这种结构使安装轴衬60能够相对于柄部组件100绕纵向轴线A-A旋转。脊构件50通过脊销66不可旋转地销接至安装轴衬60。另外,旋转旋钮70附接到安装轴衬60。例如,旋钮70具有中空安装凸缘部72,该中空安装凸缘部的尺寸被设定成将安装轴衬60的一部分接收在其中。旋钮70可由例如玻璃或碳填充尼龙、聚碳酸酯、等制成,并且也通过脊销66附连到安装轴衬60。另外,向内突起的保留凸缘74形成于安装凸缘部72上并能够延伸至形成于安装轴衬60中的径向沟槽68中。因此,外科医生可通过抓紧旋转旋钮70并使其相对于柄部组件100旋转,而使脊构件50(及附接到脊构件50的端部执行器12)围绕纵向轴线A-A沿360°路径旋转。As can further be seen in FIG. 1 , spine member 50 passes through and is supported by mounting bushing 60 , which is rotatably attached to handle assembly 100 . The mounting bushing 60 has a proximal flange 62 and a distal flange 64 that define a rotational groove 65 that enables the leading edge portion 101 of the handle assembly 100 to be rotatable. received in between. This configuration enables the mounting bushing 60 to rotate relative to the handle assembly 100 about the longitudinal axis AA. The spine member 50 is non-rotatably pinned to the mounting bushing 60 by a spine pin 66 . Additionally, a rotary knob 70 is attached to the mounting bushing 60 . For example, the knob 70 has a hollow mounting flange portion 72 sized to receive a portion of the mounting bushing 60 therein. Knob 70 may be made of, for example, glass or carbon filled nylon, polycarbonate, etc., and is also attached to the mounting bushing 60 by a spine pin 66. Additionally, an inwardly projecting retention flange 74 is formed on the mounting flange portion 72 and is capable of extending into the radial groove 68 formed in the mounting bushing 60 . Thus, the surgeon can rotate the spine member 50 (and the end effector 12 attached to the spine member 50) along a 360° path about the longitudinal axis AA by grasping the rotation knob 70 and rotating it relative to the handle assembly 100 .
砧座20由砧座弹簧21和/或另一个偏置构造保持在打开位置。通过大体被标记为109的击发系统,砧座20可从打开位置选择性地运动到各种闭合或夹紧位置以及击发位置。击发系统109包括“击发构件”110,其包括中空击发管110。中空击发管110可在脊构件50上轴向地运动,因此形成细长轴组件40的外部。击发管110可由聚合物或其他合适的材料制成,并具有附接到击发系统109的击发轭114的近侧末端。例如,击发轭114可模压到击发管110的近侧末端。然而,也可采用其他紧固件构造。Anvil 20 is held in the open position by anvil spring 21 and/or another biasing formation. Anvil 20 is selectively movable from an open position to various closed or clamped and fired positions by a firing system generally designated 109 . The firing system 109 includes a “firing member” 110 that includes a hollow firing tube 110 . Hollow firing tube 110 is axially movable on spine member 50 , thus forming the exterior of elongated shaft assembly 40 . Firing tube 110 may be fabricated from a polymer or other suitable material and has a proximal end that is attached to firing yoke 114 of firing system 109 . For example, firing yoke 114 may be molded to the proximal end of firing tube 110 . However, other fastener configurations may also be used.
如在图1中可看出,击发轭114能够可旋转地支撑在支撑衬圈120中,该支撑衬圈能够在柄部组件100中轴向运动。支撑衬圈120具有一对侧向延伸的翅片,该对翅片的尺寸设定成可滑动地接收在形成于左手壳体构件和右手壳体构件中的翅片狭槽内。因此,支撑衬圈120可在柄部外壳100中轴向滑动,同时使击发轭114及击发管110能够相对于支撑衬圈120围绕纵向轴线A-A旋转。根据本发明,穿过击发管110提供纵向狭槽,以使脊销66能够穿过纵向狭槽延伸至脊构件50中,同时有利于击发管110在脊构件50上轴向行进。As can be seen in FIG. 1 , firing yoke 114 can be rotatably supported in a support collar 120 that can move axially within handle assembly 100 . The support collar 120 has a pair of laterally extending fins sized to be slidably received within fin slots formed in the left and right hand housing members. Accordingly, the support collar 120 is axially slidable within the handle housing 100 while enabling the firing yoke 114 and firing tube 110 to rotate relative to the support collar 120 about the longitudinal axis A-A. In accordance with the present invention, a longitudinal slot is provided through firing tube 110 to enable spine pin 66 to extend through the longitudinal slot into spine member 50 while facilitating axial travel of firing tube 110 over spine member 50 .
击发系统109还包括击发触发器130,该击发触发器用于控制击发管110在脊构件50上的轴向移动。参见图1。击发管110的此种沿远侧方向运动至与砧座20进行击发相互作用的轴向运动在本文中被称为“击发运动”。如在图1中可看出,击发触发器130通过枢轴销132可活动地或可枢转地联接到柄部组件100。采用扭转弹簧135来偏置击发触发器130远离柄部组件100的手枪式握把部107而到达未致动的“打开”或起始位置。如在图1中可看出,击发触发器130具有上部134,该上部可运动地附接(销接)到击发链节136,该击发链节可运动地附接(销接)到支撑衬圈120。因此,击发触发器130从起始位置(图1)朝相邻柄部组件100的手枪式握把部分107的结束位置的击发触发器130的运动将使击发轭114和击发管110在远侧方向“DD”中运动。击发触发器130远离柄部组件100的手枪式握把部107的运动(在扭转弹簧135的偏置下)将使得击发轭114和击发管110在脊构件50上沿近侧方向“PD”运动。The firing system 109 also includes a firing trigger 130 for controlling the axial movement of the firing tube 110 on the spine member 50 . See Figure 1. This axial movement of the firing tube 110 in the distal direction into firing interaction with the anvil 20 is referred to herein as "firing motion." As can be seen in FIG. 1 , firing trigger 130 is movably or pivotally coupled to handle assembly 100 by pivot pin 132 . A torsion spring 135 is employed to bias the firing trigger 130 away from the pistol grip portion 107 of the handle assembly 100 to an unactuated "open" or home position. As can be seen in FIG. 1 , the firing trigger 130 has an upper portion 134 that is movably attached (pinned) to a firing link 136 that is movably attached (pinned) to the support bushing. Circle 120. Accordingly, movement of the firing trigger 130 from the starting position ( FIG. 1 ) toward the finishing position of the pistol grip portion 107 of the adjacent handle assembly 100 will cause the firing yoke 114 and firing tube 110 to be positioned distally. Movement in direction "DD". Movement of the firing trigger 130 away from the pistol grip portion 107 of the handle assembly 100 (under the bias of the torsion spring 135) will cause the firing yoke 114 and firing tube 110 to move on the spine member 50 in the proximal direction “PD” .
本发明可与不同尺寸和构型的植入式钉仓一起使用。例如,当结合第一击发衔接子140使用时,外科器械10可与支撑植入式钉仓30的约20mm长(或以其他长度)的5mm端部执行器12一起使用。这种端部执行器尺寸可尤其非常适用于例如实现相对精细的解剖及血管处理。然而,如下文所更详细所述,例如也可通过将第一击发衔接子140更换为第二击发衔接子而将外科器械10与其他尺寸的端部执行器和钉仓结合使用。作为另外的另选形式,细长轴组件40能够附接到仅一种形式或尺寸的端部执行器。The present invention can be used with implantable staple cartridges of different sizes and configurations. For example, when used in conjunction with first firing adapter 140 , surgical instrument 10 may be used with a 5 mm end effector 12 that is about 20 mm long (or otherwise long) that supports implantable staple cartridge 30 . Such an end effector size may be particularly well-suited for, for example, achieving relatively fine dissections and vascular treatments. However, as described in more detail below, surgical instrument 10 may also be used with other sized end effectors and staple cartridges, for example by replacing first firing adapter 140 with a second firing adapter. As a further alternative, the elongate shaft assembly 40 can be attached to only one form or size of end effector.
现在将阐释一种将端部执行器12可取出地联接到脊构件50的方法。通过将细长通道14上的保持耳轴17插入脊构件50中的耳轴支架52中来开始联接过程。随后,外科医生将击发触发器130朝向外壳组件100的手枪式握把107推进,以将击发管110和第一击发衔接子140向远侧推进到细长通道14的近侧末端部分47之上,从而将耳轴17保持在其各自的支架52中。在耳轴17上方的第一击发衔接子140的此类位置在此称为“联接位置”。本发明也可具有端部执行器锁定组件,用于在端部执行器12附接到脊构件50之后将击发触发器130锁定就位。One method of removably coupling end effector 12 to spine member 50 will now be explained. The coupling process begins by inserting the retaining trunnion 17 on the elongated channel 14 into the trunnion bracket 52 in the spine member 50 . Subsequently, the surgeon advances the firing trigger 130 toward the pistol grip 107 of the housing assembly 100 to advance the firing tube 110 and the first firing adapter 140 distally over the proximal end portion 47 of the elongated channel 14 , thereby retaining the trunnions 17 in their respective brackets 52 . Such a position of the first firing adapter 140 above the trunnion 17 is referred to herein as a "coupling position". The present invention may also have an end effector locking assembly for locking the firing trigger 130 in place after the end effector 12 is attached to the spine member 50 .
更具体地讲,端部执行器锁定组件160的一个实施例包括保持销162,该保持销被可运动地支撑在击发触发器130的上部134中。如上所述,击发管110必须首先向远侧被推进至联接位置,其中第一击发衔接子140将端部执行器12的保持耳轴17保持在脊构件50中的耳轴支架52中。外科医生通过从起始位置朝手枪式握把107牵拉击发触发器130而将击发衔接子140向远侧推进到所述联接位置。当击发触发器130被首先致动时,保持销162向远侧运动,直到击发管110将第一击发衔接子140推进到联接位置,此时保持销162被偏置到形成于壳体构件中的锁定腔164中。任选地,当保持销162进入锁定腔164中时,销162可发出可听见的“咔嗒”声或其他声音,而且为外科医生提供端部执行器12已被“锁定”到脊构件50上的触觉指示。另外,只要不有意地将保留销162偏置出锁定腔164,外科医生便不会无意间致动击发触发器130以开始使端部执行器12中的钉32成形。相似地,如果外科医生释放处于联接位置的击发触发器130,则保留销162会使击发触发器130保持在该位置,以防止击发触发器130返回至起始位置并因此从脊构件50释放端部执行器12。More specifically, one embodiment of the end effector lock assembly 160 includes a retaining pin 162 movably supported in the upper portion 134 of the firing trigger 130 . As described above, the firing tube 110 must first be advanced distally to the coupled position wherein the first firing adapter 140 retains the retaining trunnion 17 of the end effector 12 in the trunnion bracket 52 in the spine member 50 . The surgeon advances the firing adapter 140 distally to the coupled position by pulling the firing trigger 130 from the starting position toward the pistol grip 107 . When the firing trigger 130 is first actuated, the retaining pin 162 moves distally until the firing tube 110 advances the first firing adapter 140 to the coupled position, at which point the retaining pin 162 is biased into the housing member. in the locking cavity 164 of the Optionally, when the retaining pin 162 enters the locking cavity 164, the pin 162 can emit an audible "click" or other sound and provide the surgeon with an indication that the end effector 12 has been "locked" to the spine member 50. tactile indication on the Additionally, as long as the retention pin 162 is not intentionally biased out of the locking cavity 164 , the surgeon cannot inadvertently actuate the firing trigger 130 to begin forming the staples 32 in the end effector 12 . Similarly, if the surgeon releases the firing trigger 130 in the coupled position, the retention pin 162 will keep the firing trigger 130 in this position, preventing the firing trigger 130 from returning to the starting position and thus releasing the end from the spine member 50 Department actuator 12.
本发明还可包括击发系统锁定按钮137,该击发系统锁定按钮以能够枢转的方式附接到柄部组件100。在一种形式中,击发系统锁定按钮137具有在其远侧末端上形成的闩锁138,该闩锁被取向成当击发释放按钮处于第一闩锁位置时闩锁138接合击发轭114。如在图1中可看出,闩锁弹簧139用于将击发系统锁定按钮137偏置到第一闩锁位置。在各种情况下,闩锁138用于在以下点处接合击发轭114:在该点处,脊构件50上的击发轭114的位置对应于其中第一击发衔接子140即将朝远侧推进到砧座20上的夹紧滑道28上的点。应当理解,随着第一击发衔接子140沿轴向向夹紧滑道28上推进,砧座20将沿路径运动,使得钉成形表面部22基本上平行于钉仓30的顶面36。The present invention may also include a firing system lock button 137 that is pivotally attached to the handle assembly 100 . In one form, the firing system lockout button 137 has a latch 138 formed on its distal end oriented so that the latch 138 engages the firing yoke 114 when the firing release button is in the first latched position. As can be seen in FIG. 1 , a latch spring 139 is used to bias the firing system lock button 137 to the first latched position. In each case, the latch 138 is used to engage the firing yoke 114 at the point at which the position of the firing yoke 114 on the spine member 50 corresponds to where the first firing adapter 140 is about to be advanced distally. Point on clamping slide 28 on anvil 20 . It should be appreciated that as the first firing adapter 140 is advanced axially up the clamping sled 28 , the anvil 20 will move along a path such that the staple forming surface portion 22 is substantially parallel to the top surface 36 of the staple cartridge 30 .
在端部执行器12联接到脊构件50之后,通过首先压下击发系统锁定按钮137而开始钉成形过程,以使击发轭114能够在脊构件50上进一步朝远侧运动并最终将砧座20压缩至钉仓30中。在压下击发系统锁定按钮137之后,外科医生继续朝手枪式握把107致动击发触发器130,从而将第一钉衬圈140的驱动到对应的钉成形滑道29上,以迫使砧座20与钉仓30中的钉32成形接触。击发系统锁定按钮137防止在外科医生准备好开始钉成形过程之前无意地使钉32成形。在此类实施例中,外科医生必须在击发触发器130可被进一步致动之前压下击发系统锁定按钮137以开始钉成形过程。After the end effector 12 is coupled to the spine member 50, the staple forming process is initiated by first depressing the firing system lock button 137 to enable the firing yoke 114 to move further distally on the spine member 50 and eventually the anvil 20 Compressed into the staple cartridge 30. After depressing the firing system lock button 137, the surgeon proceeds to actuate the firing trigger 130 toward the pistol grip 107, thereby driving the first staple collar 140 onto the corresponding staple forming slide 29 to force the anvil 20 is in forming contact with the staples 32 in the staple cartridge 30. The firing system lockout button 137 prevents inadvertent forming of the staples 32 until the surgeon is ready to begin the staple forming process. In such embodiments, the surgeon must depress the firing system lockout button 137 to begin the staple forming process before the firing trigger 130 can be further actuated.
外科器械10可根据需要而仅用作组织缝合装置。然而,本发明也可包括组织切割系统,该组织切割系统大体被标记为170。在至少一种形式中,组织切割系统170包括刀构件172,可通过致动刀行进触发器200将该刀构件选择性地从邻近侧末端部执行器12的近侧末端的未致动位置推进到致动位置。刀构件172被可动地支撑在脊构件50内,并附接到刀杆180或以其他的方式从刀杆180突起。刀构件172可由例如具有大于38HRC(洛氏硬度C级)的硬度的420或440不锈钢制成,并可具有形成于其远侧末端174上的组织切割刀刃176,并能够可滑动地延伸穿过砧座20中的狭槽以及在钉仓30中居中设置的狭槽33,以切穿夹紧于端部执行器12中的组织。刀杆180延伸穿过脊构件50并且具有与刀传送装置传动交接的近侧末端部分,该刀传送装置可操作地附接到刀行进触发器200。刀行进触发器200附接到枢轴销132,使得其可在无需致动击发触发器130的情况下进行枢转或以其他的方式被致动。根据本发明,第一刀齿轮192也附接到枢轴销132,使得刀行进触发器200的致动也使第一刀齿轮192枢转。第一刀齿轮192与柄部壳体100之间附接有击发返回弹簧202,以将刀推进触发器200偏置到起始位置或未致动位置。Surgical instrument 10 may be used only as a tissue stapling device if desired. However, the present invention may also include a tissue cutting system, generally designated 170 . In at least one form, tissue cutting system 170 includes knife member 172 that can be selectively advanced from an unactuated position adjacent the proximal end of side tip effector 12 by actuating knife advancement trigger 200 . to the actuated position. Knife member 172 is movably supported within spine member 50 and is attached to or otherwise protrudes from knife bar 180 . Knife member 172 can be made of, for example, 420 or 440 stainless steel having a hardness greater than 38 HRC (Rockwell C scale), and can have a tissue cutting edge 176 formed on its distal tip 174 and can slidably extend through A slot in anvil 20 and a slot 33 centrally located in cartridge 30 to cut through tissue clamped in end effector 12 . Knife bar 180 extends through spine member 50 and has a proximal end portion in driving interface with a knife transport that is operably attached to knife advance trigger 200 . Knife travel trigger 200 is attached to pivot pin 132 such that it can pivot or otherwise be actuated without actuating firing trigger 130 . According to the present invention, first knife gear 192 is also attached to pivot pin 132 such that actuation of knife travel trigger 200 also pivots first knife gear 192 . A firing return spring 202 is attached between the first knife gear 192 and the handle housing 100 to bias the knife advancement trigger 200 to a home or unactuated position.
刀传送装置还包括第二刀齿轮194,该第二刀齿轮可旋转地支撑在第二齿轮轴上并与第一刀齿轮192啮合。第二刀齿轮194与支撑在第三齿轮轴上的第三刀齿轮196啮合。第四刀齿轮198也被支撑在第三齿轮轴195上。第四刀齿轮198能够传动接合在刀杆180的近侧末端上的一系列环形齿轮齿或环。因此,这种结构使第四刀齿轮198能够沿远侧方向“DD”或近侧方向“PD”轴向地驱动刀杆180,同时使击发杆180相对于第四刀齿轮198绕纵向轴线A-A旋转。因此,外科医生可通过朝柄部组件100的手枪式握把107牵拉刀推进触发器200而使击发杆180轴向地推进并最终朝远侧推动刀构件172。The knife transmission device also includes a second knife gear 194 rotatably supported on the second gear shaft and meshed with the first knife gear 192 . The second knife gear 194 meshes with a third knife gear 196 supported on the third gear shaft. The fourth cutter gear 198 is also supported on the third gear shaft 195 . The fourth knife gear 198 can drivingly engage a series of ring gear teeth or rings on the proximal end of the knife bar 180 . Thus, this configuration enables the fourth knife gear 198 to axially drive the knife bar 180 in either the distal direction "DD" or the proximal direction "PD", while simultaneously orienting the firing rod 180 about the longitudinal axis A-A relative to the fourth knife gear 198. rotate. Accordingly, the surgeon may axially advance the firing rod 180 and ultimately the knife member 172 distally by pulling the knife advancement trigger 200 toward the pistol grip 107 of the handle assembly 100 .
本发明还包括刀锁定系统210,该刀锁定系统防止刀构件172的推进,除非击发触发器130已被牵拉至完全击发位置。因此,这种结构将防止刀推进系统170的激活,除非钉已首先被击发或成形于组织中。如在图1中可看出,刀锁定系统210的各种具体实施包括刀锁定杆211,该刀锁定杆211被枢转地支撑在柄部组件100的手枪式握把部107中。刀锁定杆211具有激活端212,当击发触发器130处于完全击发位置时,激活端212能够被击发触发器130接合。另外,刀锁定杆211在其另一端上具有保持吊钩214,该保持吊钩能够以吊钩方式接合第一切割齿轮192上的闩锁杆216。采用刀锁定弹簧218来将刀锁定杆211偏置到“锁定”位置。在该“锁定”位置中,保持吊钩214保持与闩锁杆216接合,从而防止刀推进触发器200的致动,除非击发触发器130处于完全击发位置。The present invention also includes a knife locking system 210 that prevents advancement of the knife member 172 unless the firing trigger 130 has been pulled to the fully fired position. Thus, this configuration will prevent activation of the knife advancement system 170 unless the staples have first been fired or formed into the tissue. As can be seen in FIG. 1 , various implementations of the knife locking system 210 include a knife locking bar 211 pivotally supported in the pistol grip portion 107 of the handle assembly 100 . The knife locking lever 211 has an activating end 212 that can be engaged by the firing trigger 130 when the firing trigger 130 is in the fully fired position. In addition, the knife locking lever 211 has a retaining hook 214 on its other end which is capable of hooking into a latch lever 216 on the first cutting gear 192 . A knife lock spring 218 is employed to bias the knife lock lever 211 to the "locked" position. In this "locked" position, the retaining hook 214 remains engaged with the latch bar 216, thereby preventing actuation of the knife advancing trigger 200 unless the firing trigger 130 is in the fully fired position.
在钉被“击发”(成形)至靶组织中之后,外科医生可压下击发触发器释放按钮167,以使击发触发器130能够在扭转弹簧135的偏置作用下返回至起始位置,从而使砧座20能够在弹簧21的偏置作用下偏置到打开位置。当处于打开位置时,外科医生可撤出端部执行器12而留下可植入的钉仓30和钉32。在其中端部执行器穿过通道、工作通道等而被插入的应用中,外科医生将通过激活击发触发器130而使砧座20返回至闭合位置,以使端部执行器12能够通过所述通道或工作通道被撤出。然而,如果外科医生想要在击发钉之后切割靶组织,则外科医生以上述方式激活刀行进触发器200,以驱动刀杆172穿过靶组织到达端部执行器的端部。随后,外科医生可释放刀行进触发器200,以使击发返回弹簧202能够使击发传送装置将刀杆172返回至起始(未致动)位置。一旦刀杆172返回至起始位置,外科医生便可打开端部执行器钳口13、15,以将植入式仓30释放于患者体内并随后从患者体内撤出端部执行器12。因此,此类外科器械有利于使用可通过相对较小的工作通道和通道而被插入的小的植入式钉仓,同时为外科医生提供如下选择:在不切割组织的情况下击发钉、或视需要在击发钉之后还切割组织。After the staples have been "fired" (formed) into the target tissue, the surgeon can depress the firing trigger release button 167 to allow the firing trigger 130 to return to the starting position under the bias of the torsion spring 135, thereby The anvil 20 is enabled to be biased to the open position under the bias of the spring 21 . When in the open position, the surgeon can withdraw end effector 12 leaving implantable staple cartridge 30 and staples 32 behind. In applications where the end effector is inserted through a channel, working channel, etc., the surgeon will return the anvil 20 to the closed position by activating the firing trigger 130 to enable the end effector 12 to pass through the Channel or working channel is withdrawn. However, if the surgeon wants to cut the target tissue after firing the staples, the surgeon activates the knife travel trigger 200 in the manner described above to drive the knife bar 172 through the target tissue to the end of the end effector. Subsequently, the surgeon may release the knife travel trigger 200 to enable the firing return spring 202 to enable the firing delivery mechanism to return the knife bar 172 to the home (non-actuated) position. Once the knife bar 172 is returned to the starting position, the surgeon can open the end effector jaws 13, 15 to release the implantable cartridge 30 in the patient and subsequently withdraw the end effector 12 from the patient. Accordingly, such surgical instruments facilitate the use of small implantable staple cartridges that can be inserted through relatively small working channels and channels, while providing the surgeon with the option of firing the staples without cutting tissue, or Tissue is also cut if desired after firing the staples.
本发明的各种独特和新型实施例采用可压缩的钉仓,所述可压缩的钉仓支撑处于基本上固定位置以用于被砧座成形接触的钉。将砧座驱动到未成形钉中,其中例如所达到的钉成形的程度取决于砧座被驱动到钉中多远。此类构造使得外科医生能够调节施加至钉的成形或击发压力的量,从而改变钉的最终成形高度。在本发明的其他实施例中,外科缝合构造可采用钉驱动元件,该钉驱动元件可将钉朝向砧座抬起。这些在下文中有更详细的描述。Various unique and novel embodiments of the present invention employ compressible staple cartridges that support staples in a substantially fixed position for forming contact by an anvil. The anvil is driven into the unformed staple, wherein eg the degree of staple formation achieved depends on how far the anvil is driven into the staple. Such configurations enable the surgeon to adjust the amount of forming or firing pressure applied to the staples, thereby varying the final formed height of the staples. In other embodiments of the invention, surgical stapling configurations may employ staple driving elements that lift the staples toward the anvil. These are described in more detail below.
任选地,参照上文,施加到可移动砧座的击发动作的量取决于击发触发器的致动的程度。例如,如果外科医生想要获得仅部分成形的钉,则仅需朝手枪式握把107部分地向内压下击发触发器。要想获得更多的钉成形,外科医生仅需进一步压紧击发触发器,使得砧座被进一步驱动以与钉进行成形接触。如本文所用,术语“成形接触”是指钉成形表面或钉成形凹坑已接触钉腿的末端并已开始将腿部成形或弯曲至成形位置。钉成形的程度是指钉腿被折叠的程度且最终是指上文所提及的钉的成形高度。本领域中的普通技术人员将进一步理解,因为在对砧座20施加击发运动时,砧座20是以与钉仓基本上平行的关系进行运动,所以钉基本上同时成形并具有基本上相同的成形高度。Optionally, referring to above, the amount of firing action applied to the movable anvil depends on the degree of actuation of the firing trigger. For example, if the surgeon wishes to obtain only partially formed staples, the firing trigger only needs to be partially depressed inwardly towards the pistol grip 107 . To achieve more staple formation, the surgeon simply depresses the firing trigger further, causing the anvil to be driven further into forming contact with the staples. As used herein, the term "formed contact" means that a staple forming surface or staple forming pocket has contacted the end of a staple leg and has begun to form or bend the leg into a formed position. The degree of staple formation refers to the extent to which the staple legs are folded and ultimately the above-mentioned formed height of the staple. Those of ordinary skill in the art will further appreciate that because the anvil 20 moves in a substantially parallel relationship with the staple cartridge when the firing motion is applied to the anvil 20, the staples are formed substantially simultaneously and have substantially the same Forming height.
图2和图3示出了可供选择的端部执行器12”,除以下能够容纳刀杆172’的不同点之外,端部执行器12”类似于上述端部执行器12’。刀杆172’联接到刀杆180或自刀杆180突起,并且除此之外以上文中关于刀杆172所述的方式进行操作。然而,在此实施例中,刀杆172’足够长以横贯端部执行器12”的整个长度,因此端部执行器12”中未采用单独的远侧刀构件。刀杆172’上形成有上横向构件173’和下横向构件175’。上横向构件173’被取向成可滑动地横贯砧座20”中对应的细长狭槽250,并且下横向构件175’被取向成横贯端部执行器12”的细长通道14”中的细长狭槽252。砧座20”中也设置有脱离狭槽(未示出),使得当刀杆172’被驱动至端部执行器12”内的结束位置时,上横向构件173’穿过对应的狭槽而下落,以使砧座20”能够运动至打开位置,从而与所缝合和切割的组织脱离。砧座20”可除此之外与上述砧座20相同,并且细长通道14”可除此之外与上述细长通道14相同。Figures 2 and 3 illustrate an alternative end effector 12", which is similar to the end effector 12' described above except for the following difference in that it can accommodate a knife bar 172'. Knife bar 172' is coupled to or projects from knife bar 180 and otherwise operates in the manner described above with respect to knife bar 172. However, in this embodiment, the knife bar 172' is long enough to traverse the entire length of the end effector 12", so a separate distal knife member is not employed in the end effector 12". Formed on the knife bar 172' are an upper cross member 173' and a lower cross member 175'. The upper cross member 173' is oriented to slidably traverse a corresponding elongated slot 250 in the anvil 20", and the lower cross member 175' is oriented to traverse the elongated slot 250 in the elongated channel 14" of the end effector 12". Long slot 252. An escape slot (not shown) is also provided in the anvil 20" so that when the knife bar 172' is driven to the end position within the end effector 12", the upper cross member 173' passes The corresponding slots drop down to enable the anvil 20" to move to the open position, thereby disengaging from the stapled and cut tissue. The anvil 20" may otherwise be identical to the anvil 20 described above, and the elongated channel 14" may be otherwise identical to the elongated channel 14 described above.
在这些实施例中,砧座20”由弹簧或其他打开结构(未示出)偏置到完全打开位置(图2)。砧座20”通过击发衔接子150以上述方式进行的轴向行进而在打开位置与完全夹紧位置之间运动。一旦击发衔接子150推进至完全夹紧位置(图3),外科医生便可随后以上述方式朝远侧推进刀杆172”。如果外科医生想要将端部执行器用作抓紧装置来操纵组织,则可将击发衔接子朝近侧运动,以允许砧座20”远离细长通道14”运动,如图4中的虚线所示。在此实施例中,档刀杆172”朝远侧运动时,上横向构件173’和下横向构件175’同时拉动砧座20”和细长通道14”,以在刀杆172”穿过端部执行器12”朝远侧推进时达到实现期望的钉成形。参见图5。因此,在此实施例中,钉成形是与组织切割同时发生,但钉本身可在刀杆172”朝远侧被驱动时依序成形。In these embodiments, anvil 20" is biased by a spring or other opening structure (not shown) to the fully open position (FIG. 2). Anvil 20" is activated by axial travel of firing adapter 150 in the manner described above. Movement between open and fully clamped positions. Once the firing adapter 150 is advanced to the fully clamped position (FIG. 3), the surgeon can then advance the knife bar 172" distally in the manner described above. If the surgeon wishes to use the end effector as a grasping device to manipulate tissue, The firing adapter can then be moved proximally to allow the anvil 20" to move away from the elongated channel 14", as shown in phantom in Figure 4. In this embodiment, when the stop bar 172" moves distally , the upper cross member 173' and the lower cross member 175' simultaneously pull the anvil 20" and the elongated channel 14" to achieve the desired staple formation as the knife bar 172" is advanced distally through the end effector 12" . See Figure 5. Thus, in this embodiment, staple forming occurs simultaneously with tissue cutting, but the staples themselves can be sequentially formed as the knife bar 172" is driven distally.
本发明的各种外科钉仓及外科器械的独特且新型的特征使所述钉仓中的钉能够排列成一或多条线性或非线性的线。细长狭槽的每个侧上可提供多条这种钉线,所述细长狭槽居中地设置在钉仓内,以用于接收穿过所述细长狭槽的组织切割构件。在一种排列方式中,例如成一条线的钉可大体上平行于位于相邻钉线中的钉但与其偏离。作为另外的另选形式,一条或多条钉线可本质上为非线性的。也就是说,钉线中的至少一个钉的基部可沿基本上与同一钉线中的其他钉的基部横切的轴线延伸。例如,细长狭槽的每一侧上的钉线可具有锯齿形外观。The unique and novel features of the various surgical staple cartridges and surgical instruments of the present invention enable the staples in the cartridges to be aligned in one or more linear or non-linear lines. A plurality of such staple wires may be provided on each side of an elongated slot centrally disposed within the staple cartridge for receiving a tissue cutting member therethrough. In one arrangement, for example, staples in a line may be generally parallel to but offset from staples in an adjacent staple line. As a further alternative, the one or more staple lines may be non-linear in nature. That is, the base of at least one staple in the staple line can extend along an axis that is substantially transverse to the bases of other staples in the same staple line. For example, the staple lines on each side of the elongated slot may have a zigzag appearance.
根据本发明,钉仓可包括仓体和储存于仓体中的多个钉。在使用中,可将钉仓引入手术部位中并将其定位在所处理的组织的侧上。另外,可将钉成形砧座定位在组织的相对侧上。砧座可由第一钳口携载并且钉仓可由第二钳口携载,其中第一钳口和/或第二钳口可朝另一钳口运动。一旦钉仓及砧座相对于组织被定位,则可从钉仓本体中射出钉,使得钉可刺穿组织并接触钉成形砧座。一旦从钉仓本体中部署钉,则可从手术部位移除钉仓本体。钉仓或钉仓的至少一部分中可植入有钉。例如,如下文所更详细地描述,钉仓可包括仓体,当砧座从打开位置运动到闭合位置时,该仓体可被砧座压缩、压碎和/或塌缩。当仓体被压缩、压溃和/或塌缩时,位于仓体中的钉可通过砧座而变形。作为另外一种选择,用于支撑钉仓的钳口可朝砧座运动至闭合位置。在两种情形的任一种中,当钉至少部分地定位在仓体内时,钉可变形。在一些情况下,钉可不从钉仓中射出,而在其他情况下,钉可与仓体的一部分一起从钉仓中被射出。According to the present invention, a staple cartridge may include a cartridge body and a plurality of staples stored in the cartridge body. In use, the staple cartridge can be introduced into the surgical site and positioned on the side of the treated tissue. Additionally, the staple forming anvils can be positioned on opposite sides of the tissue. The anvil can be carried by the first jaw and the staple cartridge can be carried by the second jaw, wherein the first jaw and/or the second jaw can be moved toward the other jaw. Once the staple cartridge and anvil are positioned relative to the tissue, the staples can be ejected from the staple cartridge body such that the staples can pierce the tissue and contact the staple forming anvil. Once the staples are deployed from the cartridge body, the cartridge body can be removed from the surgical site. The staple cartridge or at least a portion of the staple cartridge may have staples implanted therein. For example, as described in more detail below, a staple cartridge can include a cartridge body that can be compressed, crushed, and/or collapsed by the anvil as the anvil moves from an open position to a closed position. When the cartridge body is compressed, crushed and/or collapsed, the staples located in the cartridge body can be deformed by the anvil. Alternatively, the jaws for supporting the staple cartridge are movable toward the anvil to a closed position. In either case, the staples may deform when they are at least partially positioned within the cartridge body. In some cases, the staples may not be ejected from the staple cartridge, while in other cases, the staples may be ejected from the staple cartridge with a portion of the cartridge body.
现在参见图6A-图6D,可压缩钉仓(诸如钉仓1000)例如可包括可压缩、植入式仓体1010,以及此外定位于可压缩仓体1010中的多个钉1020,但图6A-图6D仅示出一个钉1020。图6A示出由钉仓支撑件或钉仓通道1030支撑的钉仓1000,其中钉仓1000被示出为处于未压缩条件。在这种未压缩条件中,砧座1040可接触或不接触组织T。在使用中,砧座1040可从打开位置运动至接触组织T,如图6B所示,并将组织T抵靠仓体1010定位。即使砧座1040可将组织T抵靠钉仓体1010的组织接触表面1019定位,然而再次参见图6B,钉仓体1010此时可受到极少的(如果有的话)压缩力或压力,并且钉1020可保持在未成形或未击发条件下。如图6A和图6B所示,钉仓体1010可包括一个或多个层,并且钉1020的钉腿1021可穿过这些层向上延伸。仓体1010可包括第一层1011、第二层1012、第三层1013和第四层1014,其中第二层1012可定位在第一层1011与第三层1013中间,其中第三层1013可定位在第二层1012与第四层1014中间。例如,钉1020的基部1022可定位在第四层1014中的腔体1015中,并且钉腿1021可从基部1022向上延伸并且穿过第四层1014、第三层1013和第二层1012。任选地,每个可变形腿1021可包括顶端,诸如锋利的顶端1023,例如当钉仓1000处于未压缩条件时,该锋利的顶端可定位在第二层1012中。例如,顶端1023可不延伸至和/或穿过第一层1011,其中当钉仓1000处于未压缩条件时,顶端1023可不突起穿过组织接触表面1019。当钉仓处于未压缩条件时,锋利的顶端1023可定位在第三层1013和/或任何其他合适的层中。作为另外一种选择,钉仓的仓体可具有任何合适的层数目,例如少于四层或多于四层。Referring now to FIGS. 6A-6D , a compressible staple cartridge, such as staple cartridge 1000, for example, can include a compressible, implantable cartridge body 1010, and furthermore a plurality of staples 1020 positioned within the compressible cartridge body 1010, but FIG. 6A - Figure 6D shows only one staple 1020. Figure 6A illustrates a staple cartridge 1000 supported by a cartridge support or cartridge channel 1030, wherein the staple cartridge 1000 is shown in an uncompressed condition. In this uncompressed condition, the anvil 1040 may or may not be in contact with the tissue T. In use, the anvil 1040 is movable from the open position to contact tissue T, as shown in FIG. 6B , and position the tissue T against the cartridge body 1010 . Even though the anvil 1040 can position the tissue T against the tissue contacting surface 1019 of the staple cartridge body 1010, yet referring again to FIG. Staples 1020 can remain in an unformed or unfired condition. As shown in FIGS. 6A and 6B , the staple cartridge body 1010 can include one or more layers, and the staple legs 1021 of the staples 1020 can extend upwardly through the layers. The cartridge body 1010 may include a first layer 1011, a second layer 1012, a third layer 1013, and a fourth layer 1014, wherein the second layer 1012 may be positioned intermediate the first layer 1011 and the third layer 1013, wherein the third layer 1013 may be It is located between the second layer 1012 and the fourth layer 1014 . For example, bases 1022 of staples 1020 can be positioned in cavities 1015 in fourth layer 1014 , and staple legs 1021 can extend upwardly from bases 1022 and through fourth layer 1014 , third layer 1013 , and second layer 1012 . Optionally, each deformable leg 1021 can include a tip, such as a sharp tip 1023, which can be positioned in second layer 1012, for example, when staple cartridge 1000 is in an uncompressed condition. For example, apex 1023 may not extend to and/or pass through first layer 1011, wherein apex 1023 may not protrude through tissue contacting surface 1019 when staple cartridge 1000 is in an uncompressed condition. The sharpened tip 1023 can be positioned in the third layer 1013 and/or any other suitable layer when the staple cartridge is in an uncompressed condition. Alternatively, the cartridge body of the staple cartridge can have any suitable number of layers, such as less than four layers or more than four layers.
任选地,如下文所更详细地描述,第一层1011可由支撑物材料和/或塑性材料(诸如聚二氧杂环己酮(PDS)和/或聚乙醇酸(PGA))构成,并且第二层1012可由可生物吸收的泡沫材料和/或可压缩止血材料(诸如氧化再生纤维素(ORC))构成。任选地,第一层1011、第二层1012、第三层1013和第四层1014中的一者或多者可将钉1020保持在钉仓体1010内,并且另外可使钉1020保持相互对齐。第三层1013可由支撑物材料或相当不可压缩的或非弹性材料构成,该材料能够将钉1020的钉腿1021相对于彼此保持在适当位置。此外,位于第三层1013的相对两侧上的第二层1012和第四层1014可稳定或减少钉1020的运动,即使第二层1012和第四层1014可包含可压缩的泡沫或弹性材料。钉腿1021的钉顶端1023可至少部分地嵌入第一层1011中。例如,第一层1011和第三层1013能够可协作地并且稳固地将钉腿1021保持在适当位置。第一层1011和第三层1013可分别由例如可生物吸收材料(诸如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚二氧杂环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL和/或PCL的复合物)的薄片构成,并且第二层1012和第四层1014可分别由至少一种止血材料或止血剂构成。Optionally, as described in more detail below, the first layer 1011 may be comprised of a support material and/or a plastic material such as polydioxanone (PDS) and/or polyglycolic acid (PGA), and The second layer 1012 may be composed of a bioabsorbable foam material and/or a compressible hemostatic material such as oxidized regenerated cellulose (ORC). Optionally, one or more of first layer 1011, second layer 1012, third layer 1013, and fourth layer 1014 can retain staples 1020 within staple cartridge body 1010, and can additionally retain staples 1020 relative to each other. align. The third layer 1013 may be composed of a strut material or a relatively incompressible or non-elastic material capable of holding the staple legs 1021 of the staples 1020 in place relative to each other. Additionally, the second layer 1012 and fourth layer 1014 on opposite sides of the third layer 1013 can stabilize or reduce movement of the staples 1020, even though the second layer 1012 and fourth layer 1014 may comprise compressible foam or elastic materials . The staple tips 1023 of the staple legs 1021 can be at least partially embedded in the first layer 1011 . For example, first layer 1011 and third layer 1013 can cooperatively and securely hold staple legs 1021 in place. The first layer 1011 and the third layer 1013 may respectively be made of, for example, a bioabsorbable material such as polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone (PDS) sold under the trade name Vicryl , polyhydroxyalkanoate (PHA), polycapron 25 (PGCL) sold under the tradename Monocryl, polycaprolactone (PCL), and/or PGA, PLA, PDS, PHA, PGCL, and/or PCL composite), and the second layer 1012 and the fourth layer 1014 may each be composed of at least one hemostatic material or hemostatic agent.
尽管第一层1011可为可压缩的,然而第二层1012可基本上比第一层1011更可压缩。例如,第二层1012的可压缩性可为第一层1011的约两倍、约三倍、约四倍、约五倍和/或约十倍。换言之,针对给定的力,第二层1012的压缩程度可为第一层1011的约两倍、约三倍、约四倍、约五倍、和/或约十倍。第二层1012的可压缩性例如可在第一层1011的大约两倍与大约十倍之间。第二层1012可包括限定于其中的多个气隙,其中第二层1012中的气隙的量和/或尺寸可被控制以提供第二层1012的期望可压缩性。与上文相似,尽管第三层1013可为可压缩的,然而第四层1014能够比第三层1013基本上更具可压缩性。例如,第四层1014的可压缩性可为第三层1013的约两倍、约三倍、约四倍、约五倍、和/或约十倍。换言之,针对给定的力,第四层1014的压缩程度可为第三层1013的约两倍、约三倍、约四倍、约五倍、和/或约十倍。第四层1014的可压缩性可在第三层1013的大约两倍与大约十倍之间。第四层1014可包括限定于其中的多个气隙,其中第四层1014中的气隙的量和/或尺寸可被控制以便提供第四层1014的期望可压缩性。在各种情形中,可通过压缩率(即,层针对给定大小的力所压缩的距离)来表达仓体或仓体层的可压缩性。例如,与具有较低压缩率的层相比,具有高压缩率的层针对施加至该层的给定大小的压缩力将压缩更大的距离。如此而言,第二层1012可比第一层1011具有更高的压缩率;相似地,第四层1014可比第三层1013具有更高的压缩率。第二层1012和第四层1014可由相同的材料构成并且可具有相同的压缩率。第二层1012和第四层1014可由具有不同压缩率的材料构成。相似地,第一层1011和第三层1013可包含相同的材料并可具有相同的压缩率。第一层1011和第三层1013可由具有不同压缩率的材料构成。While the first layer 1011 may be compressible, the second layer 1012 may be substantially more compressible than the first layer 1011 . For example, the second layer 1012 may be about two times, about three times, about four times, about five times, and/or about ten times as compressible as the first layer 1011. In other words, for a given force, the second layer 1012 may be about two times, about three times, about four times, about five times, and/or about ten times as compressed as the first layer 1011. The compressibility of the second layer 1012 may be, for example, between about twice and about ten times that of the first layer 1011 . The second layer 1012 can include a plurality of air gaps defined therein, wherein the amount and/or size of the air gaps in the second layer 1012 can be controlled to provide a desired compressibility of the second layer 1012 . Similar to above, while third layer 1013 may be compressible, fourth layer 1014 can be substantially more compressible than third layer 1013 . For example, the fourth layer 1014 may be about two times, about three times, about four times, about five times, and/or about ten times as compressible as the third layer 1013 . In other words, fourth layer 1014 may be about two times, about three times, about four times, about five times, and/or about ten times more compressible than third layer 1013 for a given force. The compressibility of the fourth layer 1014 may be between about two times and about ten times that of the third layer 1013 . The fourth layer 1014 may include a plurality of air gaps defined therein, wherein the amount and/or size of the air gaps in the fourth layer 1014 may be controlled in order to provide a desired compressibility of the fourth layer 1014 . In various cases, the compressibility of a cartridge body or a layer of a cartridge body can be expressed in terms of compressibility (ie, the distance a layer compresses for a given magnitude of force). For example, a layer with a high compressibility will compress a greater distance for a given amount of compressive force applied to the layer than a layer with a lower compressibility. As such, the second layer 1012 may have a higher compressibility than the first layer 1011 ; similarly, the fourth layer 1014 may have a higher compressibility than the third layer 1013 . The second layer 1012 and the fourth layer 1014 may be composed of the same material and may have the same compressibility. The second layer 1012 and the fourth layer 1014 may be composed of materials having different compressibility. Similarly, the first layer 1011 and the third layer 1013 may comprise the same material and may have the same compressibility. The first layer 1011 and the third layer 1013 may be composed of materials having different compressibility.
当砧座1040朝其闭合位置运动时,砧座1040可接触组织T并对组织T和钉仓1000施加压缩力,如图6C所示。在这种情形中,砧座1040可朝钉仓支撑件1030向下推动仓体1010的顶面或组织接触表面1019。钉仓支撑件1030可包括仓支撑表面1031,其能够在钉仓1000被压缩于仓支撑表面1031与砧座1040的组织接触表面1041之间时支撑钉仓1000。由于砧座1040所施加的压力,仓体1010可被压缩且砧座1040可接触钉1020。更具体地讲,仓体1010的压缩和组织接触表面1019的向下运动可使钉腿1021的顶端1023刺穿仓体1010的第一层1011、刺穿组织T并且进入砧座1040中的成形凹坑1042中。当仓体1010被砧座1040进一步压缩时,顶端1023可接触限定成形凹坑1042的壁,并且因此腿1021可向内变形或卷曲,例如如图6C所示。随着钉腿1021发生变形,同样如图6C所示,钉1020的基部1022可接触钉仓支撑件1030或由钉仓支撑件1030支撑。任选地,如下文更详细地描述,钉仓支撑件1030可包括多个支撑结构,诸如钉支撑沟槽、狭槽或槽1032,例如所述多个支撑结构能够在钉1020被变形时支撑钉1020或至少钉1020的基部1022。同样如图6C所示,第四层1014中的腔体1015可由于施加到钉仓体1010的压缩力而塌缩。除腔1015之外,钉仓本体1010还可包括一个或多个空隙(例如空隙1016),例如所述一个或多个空隙中可定位有或未定位有钉的一部分,所述一个或多个空隙能够允许仓体1010塌缩。腔体1015和/或空隙1016能够塌缩,使得限定腔体和/或壁的壁向下偏转并接触仓支撑表面1031和/或接触仓体1010的定位于腔体和/或空隙下方的层。As the anvil 1040 moves toward its closed position, the anvil 1040 can contact the tissue T and apply a compressive force to the tissue T and the staple cartridge 1000, as shown in FIG. 6C. In this case, the anvil 1040 can push the top surface or tissue contacting surface 1019 of the cartridge body 1010 downward toward the staple cartridge buttress 1030 . The staple cartridge support 1030 can include a cartridge support surface 1031 configured to support the staple cartridge 1000 when the staple cartridge 1000 is compressed between the cartridge support surface 1031 and the tissue contacting surface 1041 of the anvil 1040 . Due to the pressure exerted by the anvil 1040 , the cartridge body 1010 can be compressed and the anvil 1040 can contact the staples 1020 . More specifically, compression of the cartridge body 1010 and downward movement of the tissue contacting surface 1019 can cause the tips 1023 of the staple legs 1021 to pierce the first layer 1011 of the cartridge body 1010, penetrate the tissue T, and enter the formed shape in the anvil 1040. In the pit 1042. When the cartridge body 1010 is further compressed by the anvil 1040, the top end 1023 can contact the walls defining the forming pocket 1042, and thus the legs 1021 can deform or curl inwardly, such as shown in FIG. 6C. As the staple legs 1021 are deformed, the bases 1022 of the staples 1020 can contact or be supported by the cartridge support 1030 , also as shown in FIG. 6C . Optionally, as described in more detail below, the staple cartridge support 1030 can include a plurality of support structures, such as staple support grooves, slots, or grooves 1032, for example, capable of supporting the staples 1020 as they are deformed. The staple 1020 or at least the base 1022 of the staple 1020 . As also shown in FIG. 6C , the cavities 1015 in the fourth layer 1014 can collapse due to the compressive force applied to the cartridge body 1010 . In addition to cavity 1015, staple cartridge body 1010 may also include one or more voids (e.g., void 1016), such as a portion of which may or may not be positioned with a staple, the one or more voids. The void can allow the cartridge body 1010 to collapse. The cavity 1015 and/or void 1016 can be collapsed such that the walls defining the cavity and/or walls deflect downward and contact the cartridge support surface 1031 and/or contact a layer of the cartridge body 1010 positioned below the cavity and/or void .
在比较图6B和图6C时,显然,第二层1012和第四层1014已基本上被砧座1040所施加的压缩压力压缩。也可注意,第一层1011和第三层1013也被压缩。当砧座1040运动至其闭合位置时,砧座1040可通过朝钉仓支撑件1030向下推动组织接触表面1019而继续进一步压缩仓体1010。随着仓体1010被进一步压缩,砧座1040可使钉1020变形到其完全成形形状,如图6D所示。参见图6D,每个钉1020的腿1021可朝每个钉1020的基部1022向下变形,以便将组织T、第一层1011、第二层1012、第三层1013和第四层1014的至少一部分捕获在可变形腿1021与基部1022之间。在比较图6C和图6D时,更显然,第二层1012和第四层1014已基本上被砧座1040所施加的压缩压力进一步压缩。在比较图6C和图6D时也可注意到,第一层1011和第三层1013也已被进一步压缩。在钉1020被完全或至少充分地成形之后,砧座1040可远离组织T而被抬起,并且钉仓支撑件1030可远离和/或脱离钉仓1000运动。如图6D所示,作为以上所述的结果,仓体1010可植入有钉1020。在各种实施例中,被植入的仓体1010可沿钉线支撑组织。在一些情况下,植入的仓体1010中包含的止血剂和/或任何其他适合的治疗药物可随着时间推移来处理组织。如上所述的止血剂可减少缝合和/或切割的组织出血,同时键合剂或组织粘合剂可随着时间推移为组织提供强度。所植入的仓体1010可由诸如ORC(氧化再生纤维素)、细胞外蛋白(诸如胶原)、以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚二氧杂环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL和/或PCL的复合物的材料构成。在某些情形中,仓体1010可包括能够减小手术部位感染的可能性的抗生和/或抗菌材料,例如胶体银和/或三氯生。When comparing FIGS. 6B and 6C , it is apparent that the second layer 1012 and the fourth layer 1014 have been substantially compressed by the compressive pressure applied by the anvil 1040 . It may also be noted that the first layer 1011 and the third layer 1013 are also compressed. As the anvil 1040 moves to its closed position, the anvil 1040 can continue to further compress the cartridge body 1010 by pushing the tissue contacting surface 1019 downward toward the staple cartridge buttress 1030 . As the cartridge body 1010 is further compressed, the anvil 1040 can deform the staples 1020 to their fully formed shape, as shown in Figure 6D. Referring to FIG. 6D , the legs 1021 of each staple 1020 can be deformed downward toward the base 1022 of each staple 1020 so as to deform at least A portion is captured between the deformable leg 1021 and the base 1022 . When comparing FIGS. 6C and 6D , it is more apparent that the second layer 1012 and the fourth layer 1014 have been substantially further compressed by the compressive pressure applied by the anvil 1040 . It can also be noticed when comparing Figures 6C and 6D that the first layer 1011 and the third layer 1013 have also been further compressed. After staples 1020 are fully, or at least sufficiently, formed, anvil 1040 can be lifted away from tissue T and cartridge buttress 1030 can be moved away from and/or out of staple cartridge 1000 . As shown in Figure 6D, the cartridge body 1010 may be implanted with staples 1020 as a result of the above. In various embodiments, the implanted cartridge body 1010 can support tissue along the staple line. In some cases, the hemostatic agent and/or any other suitable therapeutic agent contained within the implanted cartridge body 1010 can treat the tissue over time. A hemostat as described above can reduce bleeding from sutured and/or cut tissue, while a bonding agent or tissue adhesive can provide strength to the tissue over time. The implanted cartridge body 1010 can be made of materials such as ORC (oxidized regenerated cellulose), extracellular proteins such as collagen, polyglycolic acid (PGA) sold under the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxa Cyclohexanone (PDS), polyhydroxyalkanoate (PHA), polycapron 25 (PGCL) sold under the tradename Monocryl, polycaprolactone (PCL), and/or PGA, PLA, PDS, PHA , PGCL and/or PCL composite materials. In some cases, the cartridge body 1010 may include antimicrobial and/or antimicrobial materials, such as colloidal silver and/or triclosan, that can reduce the likelihood of surgical site infection.
仓体1010的层可相互连接。例如,可利用至少一种粘合剂(诸如血纤维蛋白和/或蛋白水凝胶)将第二层1012粘附至第一层1011,将第三层1013粘附至第二层1012,并且将第四层1014粘附至第三层1013。尽管未示出,但仓体1010的层可通过联锁机械特征结构连接在一起。例如,第一层1011和第二层1012可各自包括相对应的联锁特征结构,诸如榫槽结构和/或燕尾榫结构。相似地,第二层1012和第三层1013可各自包括相对应的联锁特征结构,同时第三层1013和第四层1014可各自包括相对应的联锁特征结构。尽管未示出,但钉仓1000可包括例如一个或多个铆钉,该一个或多个铆钉可延伸穿过仓体1010的一个或多个层。例如,每个铆钉可包括邻近第一层1011定位的第一末端或头部以及邻近第四层1014而定位的第二头部,该第四层可被组装到铆钉的第二末端或由铆钉的第二末端形成。例如,由于仓体1010的可压缩性质,铆钉可压缩仓体1010,使得铆钉的头部可相对于仓体1010的组织接触表面1019和/或底部表面1018凹陷。例如,铆钉可由可生物吸收的材料(诸如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚二氧杂环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL和/或PCL的复合物)构成。除通过仓体1010中所容纳的钉1020之外,仓体1010的层可不彼此连接。例如,钉腿1021与仓体1010之间的摩擦接合例如可将仓体1010的层保持在一起,并且一旦钉成形,则所述层可被捕获在钉1020中。钉腿1021的至少一部分可包括可以增大钉1020与仓体1010之间的摩擦力的粗糙化表面或粗糙涂层。The layers of the cartridge body 1010 may be interconnected. For example, the second layer 1012 may be adhered to the first layer 1011, the third layer 1013 may be adhered to the second layer 1012 using at least one adhesive such as fibrin and/or protein hydrogel, and The fourth layer 1014 is adhered to the third layer 1013 . Although not shown, the layers of the cartridge body 1010 may be joined together by interlocking mechanical features. For example, the first layer 1011 and the second layer 1012 may each include corresponding interlocking features, such as a tongue and groove arrangement and/or a dovetail arrangement. Similarly, second layer 1012 and third layer 1013 can each include corresponding interlocking features, while third layer 1013 and fourth layer 1014 can each include corresponding interlocking features. Although not shown, staple cartridge 1000 may include, for example, one or more rivets that may extend through one or more layers of cartridge body 1010 . For example, each rivet can include a first end or head positioned adjacent to the first layer 1011 and a second head positioned adjacent to the fourth layer 1014, which can be assembled to the second end of the rivet or formed by the rivet. The second end is formed. For example, due to the compressible nature of the cartridge body 1010 , the rivet can compress the cartridge body 1010 such that the head of the rivet can be recessed relative to the tissue contacting surface 1019 and/or the bottom surface 1018 of the cartridge body 1010 . For example, rivets can be made of bioabsorbable materials such as polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate ( PHA), polycapron 25 (PGCL), polycaprolactone (PCL), and/or complexes of PGA, PLA, PDS, PHA, PGCL, and/or PCL sold under the tradename Monocryl). The layers of the cartridge body 1010 may not be connected to each other except through the staples 1020 contained in the cartridge body 1010 . For example, frictional engagement between the staple legs 1021 and the cartridge body 1010 can hold the layers of the cartridge body 1010 together, for example, and the layers can be captured in the staple 1020 once the staple is formed. At least a portion of the staple legs 1021 can include a roughened surface or rough coating that can increase friction between the staples 1020 and the cartridge body 1010 .
如上所述,外科器械可包括第一钳口和第二钳口,第一钳口包括钉仓支撑件1030,第二钳口包括砧座1040。任选地,如下文所更详细描述,钉仓1000可包括一个或多个保持结构,该一个或多个保持结构能够接合钉仓支撑件1030,并且因此将钉仓1000可释放地保持到钉仓支撑件1030。例如,可通过至少一种粘合剂(诸如,血纤维蛋白和/或蛋白水凝胶)将钉仓1000粘附到钉仓支撑件1030。在使用中,在至少一种情形中,尤其是在腹腔镜式和/或内窥镜式手术中,例如第二钳口可运动至与第一钳口相对的闭合位置,使得第一钳口和第二钳口可通过套管针而被插入手术部位中。例如,套管针可限定约5mm的孔或插管,第一钳口和第二钳口可通过其而被插入。第二钳口可运动至处于打开位置与闭合位置之间的部分闭合位置,该部分闭合位置可允许第一钳口和第二钳口穿过套管针被插入,而无需使钉仓体1010中所容纳的钉1020变形。例如,当第二钳口处于其部分闭合的中间位置时,砧座1040可不对钉仓体1010施加压缩力,而当第二钳口处于其部分闭合的中间位置时,砧座1040可压缩钉仓体1010。尽管当砧座1040处于这种中间位置时可压缩钉仓本体1010,然而砧座1040可不完全地压缩钉仓本体1010,以使砧座1040接触钉1020和/或使得钉1020被砧座1040变形。一旦第一钳口和第二钳口通过套管针而被插入手术部位中,则第二钳口可被再次打开,并且砧座1040及钉仓1000可如上所述相对于靶组织进行定位。As noted above, the surgical instrument can include a first jaw including the cartridge buttress 1030 and a second jaw including the anvil 1040 . Optionally, as described in more detail below, the staple cartridge 1000 can include one or more retaining structures capable of engaging the staple cartridge support 1030 and thus releasably retaining the staple cartridge 1000 to the staple Cartridge support 1030. For example, cartridge 1000 can be adhered to cartridge buttress 1030 by at least one adhesive, such as fibrin and/or protein hydrogel. In use, in at least one instance, especially laparoscopic and/or endoscopic surgery, for example the second jaw is moveable to a closed position opposite the first jaw such that the first jaw and the second jaw can be inserted through the trocar into the surgical site. For example, the trocar may define an approximately 5 mm hole or cannula through which the first and second jaws may be inserted. The second jaw is movable to a partially closed position between an open position and a closed position, which allows the first and second jaws to be inserted through the trocar without requiring the staple cartridge body 1010 to be inserted. The nails 1020 contained in the deformed. For example, when the second jaw is in its partially closed intermediate position, the anvil 1040 can exert no compressive force on the staple cartridge body 1010, and when the second jaw is in its partially closed intermediate position, the anvil 1040 can compress the staples. Warehouse body 1010. Although the staple cartridge body 1010 may be compressed when the anvil 1040 is in such an intermediate position, the anvil 1040 may not completely compress the staple cartridge body 1010 such that the anvil 1040 contacts the staples 1020 and/or causes the staples 1020 to be deformed by the anvil 1040 . Once the first and second jaws have been inserted through the trocar into the surgical site, the second jaw can be opened again and the anvil 1040 and staple cartridge 1000 can be positioned relative to the target tissue as described above.
现在参见图7A-图7D,外科缝合器的端部执行器可包括定位于砧座1140与钉仓支撑件1130中间的植入式钉仓1100。与上文相似,砧座1140可包括组织接触表面1141,钉仓1100可包括组织接触表面1119,并且钉仓支撑件1130可包括能够支撑钉仓1100的支撑表面1131。参见图7A,可利用砧座1140将组织T抵靠钉仓1100的组织接触表面1119定位而不使钉仓1100变形,并且当砧座1140处于这种位置时,组织接触表面1141可被定位成与钉仓支撑表面1131相距距离1101a,并且组织接触表面1119可被定位成与钉仓支撑表面1131相距距离1102a。然后,当砧座1140朝钉仓支撑件1130运动时,现在参见图7B,砧座1140可向下推动钉仓1100的顶部表面或组织接触表面1119,并压缩仓体1110的第一层1111和第二层1112。随着层1111和层1112被压缩,再次参见图7B,第二层1112可被压溃,并且钉1120的腿1121可刺穿第一层1111并进入到组织T中。例如,钉1120可至少部分地定位在第二层1112中的钉腔或空隙1115中,并且当第二层1112被压缩时,钉腔1115可塌缩并因此允许第二层1112围绕钉1120塌缩。第二层1112可包括盖部分1116,该盖部分可延伸于钉腔1115之上并包围或至少部分地包围钉腔1115。图7B示出了被向下压溃至钉腔1115中的盖部分1116。第二层1112可包括一个或多个弱化部分,其可有利于第二层1112的塌缩。任选地,此类弱化部分可包括例如能够有利于仓体1110的可控塌缩的划痕、穿孔和/或薄的横截面。第一层1111可包括能够有利于钉腿1121穿透第一层1111的一个或多个弱化部分。任选地,此类弱化部分可包括例如能够与钉腿1121对齐或至少基本上对齐的划痕、穿孔和/或薄的横截面。Referring now to FIGS. 7A-7D , an end effector of a surgical stapler can include an implantable staple cartridge 1100 positioned intermediate an anvil 1140 and a cartridge buttress 1130 . Similar to the above, the anvil 1140 can include a tissue contacting surface 1141 , the staple cartridge 1100 can include a tissue contacting surface 1119 , and the staple cartridge buttress 1130 can include a support surface 1131 capable of supporting the staple cartridge 1100 . 7A, anvil 1140 can be utilized to position tissue T against tissue contacting surface 1119 of staple cartridge 1100 without deforming staple cartridge 1100, and when anvil 1140 is in this position, tissue contacting surface 1141 can be positioned to A distance 1101 a from the cartridge supporting surface 1131 and a tissue contacting surface 1119 can be positioned a distance 1102 a from the cartridge supporting surface 1131 . Then, as the anvil 1140 moves toward the staple cartridge buttress 1130, referring now to FIG. Second floor 1112. As layers 1111 and 1112 are compressed, referring again to FIG. 7B , second layer 1112 can be crushed and legs 1121 of staples 1120 can pierce first layer 1111 and into tissue T. FIG. For example, staples 1120 can be positioned at least partially in staple cavities or voids 1115 in second layer 1112, and when second layer 1112 is compressed, staple cavities 1115 can collapse and thus allow second layer 1112 to collapse around staples 1120 shrink. The second layer 1112 can include a cover portion 1116 that can extend over and surround, or at least partially surround, the staple cavities 1115 . FIG. 7B shows cover portion 1116 being crushed down into staple cavity 1115 . Second layer 1112 may include one or more weakened portions that may facilitate collapse of second layer 1112 . Optionally, such weakened portions may include, for example, score marks, perforations, and/or thin cross-sections that can facilitate controlled collapse of the cartridge body 1110 . The first layer 1111 can include one or more weakened portions that can facilitate penetration of the staple legs 1121 through the first layer 1111 . Optionally, such weakened portions may include, for example, scores, perforations, and/or thinned cross-sections capable of aligning, or at least substantially aligning, with staple legs 1121 .
再次参见图7A,当砧座1140处于部分闭合的未击发位置时,砧座1140可被定位成与仓支撑表面1131相距距离1101a,使得其间限定有间隙。此间隙可由具有钉仓高度1102a的钉仓1100及组织T填充。随着砧座1140向下运动以压缩钉仓1100,再次参见图7B,组织接触表面1141与仓支撑表面1131之间的距离可由短于距离1101a的距离1101b限定。在各种情形中,砧座1140的组织接触表面1141与仓支撑表面1131之间的由距离1101b限定的间隙可大于原始的未变形的钉仓高度1102a。现在参见图7C,当砧座1140运动至更靠近仓支撑表面1131时,第二层1112可继续塌缩并且钉腿1121与成形凹坑1142之间的距离可减小。相似地,组织接触表面1141与仓支撑表面1131之间的距离可减小到距离1101c,该距离可大于、等于或小于原始的未变形仓高度1102a。现在参见图7D,砧座1140可运动至最终的击发位置,其中钉1120已完全成形或至少成形至期望高度。在这种位置中,砧座1140的组织接触表面1141可与仓支撑表面1131相距距离1101d,其中距离1101d可短于原始的未变形仓高度1102a。同样如图7D所示,钉腔1115可完全或至少基本上塌缩,并且钉1120可完全或至少基本上被塌缩的第二层1112围绕。在各种情形中,砧座1140可随后远离钉仓1100运动。一旦砧座1140从钉仓1100脱离,则仓体1110可例如至少部分地再次膨胀于各种位置(即,相邻的钉1120之间的位置)中。压溃的仓体1110可能并不回弹性地再次膨胀。成形的钉1120和另外定位在相邻的钉1120之间的仓体1110可对组织T施加压力或压缩力,这可提供各种治疗益处。Referring again to FIG. 7A , when the anvil 1140 is in the partially closed unfired position, the anvil 1140 can be positioned a distance 1101a from the cartridge support surface 1131 such that a gap is defined therebetween. This gap can be filled by a staple cartridge 1100 having a cartridge height 1102a and tissue T. As the anvil 1140 moves downward to compress the staple cartridge 1100, referring again to FIG. 7B, the distance between the tissue-contacting surface 1141 and the cartridge-supporting surface 1131 can be defined by a distance 1101b that is shorter than distance 1101a. In various circumstances, the gap defined by the distance 1101b between the tissue contacting surface 1141 of the anvil 1140 and the cartridge support surface 1131 can be greater than the original undeformed staple cartridge height 1102a. Referring now to FIG. 7C , as the anvil 1140 is moved closer to the cartridge support surface 1131 , the second layer 1112 can continue to collapse and the distance between the staple legs 1121 and the forming pockets 1142 can decrease. Similarly, the distance between the tissue contacting surface 1141 and the cartridge support surface 1131 can be reduced to a distance 1101c, which can be greater than, equal to, or less than the original undeformed cartridge height 1102a. Referring now to FIG. 7D , the anvil 1140 can be moved to a final fired position in which the staples 1120 are fully formed, or at least formed to a desired height. In such a position, the tissue contacting surface 1141 of the anvil 1140 can be a distance 1101d from the cartridge support surface 1131, where the distance 1101d can be shorter than the original undeformed cartridge height 1102a. As also shown in FIG. 7D , the staple cavities 1115 can be completely or at least substantially collapsed, and the staples 1120 can be completely or at least substantially surrounded by the collapsed second layer 1112 . In various circumstances, anvil 1140 can then be moved away from staple cartridge 1100 . Once the anvil 1140 is disengaged from the staple cartridge 1100, the cartridge body 1110 can, for example, at least partially re-expand in various positions (ie, positions between adjacent staples 1120). A collapsed cartridge body 1110 may not re-expand resiliently. The shaped staples 1120 and the cartridge body 1110 otherwise positioned between adjacent staples 1120 can apply a compressive or compressive force to the tissue T, which can provide various therapeutic benefits.
如上所述,再次参见图7A,每个钉1120可包括自其延伸的钉腿1121。尽管钉1120被绘示为包括两个钉腿1121,然而也可利用可包括一个钉腿或作为另外一种选择包括超过两个钉腿(例如三个钉腿或四个钉腿)的各种钉。如图7A所示,每个钉腿1121均可嵌入到仓体1110的第二层1112中,使得钉1120被固定于第二层1112中。钉1120可被插入仓体1110中的钉腔1115中,使得钉腿1121的顶端1123在基部1122之前进入腔体1115中。在顶端1123被插入腔体1115之后,顶端1123可被按压到盖部分1116中并切割第二层1112。钉1120可被坐置到第二层1112中的足够深度处,使得钉1120相对于第二层1112不运动或至少基本上不运动。钉1120可被坐置到第二层1112中的足够深度处,使得基部1122被定位或嵌入钉腔1115中。作为另外一种选择,基部1122可不被定位或嵌入第二层1112中。再次参见图7A,基部1122可在仓体1110的底部表面1118下方延伸。基部1122可承靠于仓支撑表面1130上或直接抵靠仓支撑表面1130定位。仓支撑表面1130可包括从其延伸和/或限定在其中的支撑结构,例如,钉1120的基部1122可被定位在例如钉仓支撑件1130中的一个或多个支撑沟槽、狭槽或槽1132中或由该一个或多个支撑沟槽、狭槽或槽1132支撑,如下文将更详细地描述。As noted above, referring again to FIG. 7A , each staple 1120 can include a staple leg 1121 extending therefrom. Although staples 1120 are shown as including two legs 1121, various staples that may include one leg or alternatively include more than two legs (e.g., three legs or four legs) may also be utilized. nail. As shown in FIG. 7A , each staple leg 1121 can be embedded into the second layer 1112 of the cartridge body 1110 such that the staples 1120 are secured in the second layer 1112 . Staples 1120 can be inserted into staple cavities 1115 in cartridge body 1110 such that tips 1123 of staple legs 1121 enter cavities 1115 before bases 1122 . After tip 1123 is inserted into cavity 1115 , tip 1123 may be pressed into cap portion 1116 and cut second layer 1112 . The staples 1120 can be seated to a sufficient depth into the second layer 1112 such that the staples 1120 do not move, or at least substantially do not, relative to the second layer 1112 . The staples 1120 can be seated to a sufficient depth into the second layer 1112 such that the bases 1122 are positioned or embedded in the staple cavities 1115 . Alternatively, the base 1122 may not be positioned or embedded in the second layer 1112 . Referring again to FIG. 7A , the base 1122 can extend below the bottom surface 1118 of the cartridge body 1110 . The base 1122 can rest on or be positioned directly against the cartridge support surface 1130 . The cartridge support surface 1130 can include support structures extending therefrom and/or defined therein, for example, the bases 1122 of the staples 1120 can be positioned in one or more support grooves, slots or slots in the staple cartridge support 1130, for example 1132 is supported in or by the one or more support grooves, slots or grooves 1132, as will be described in more detail below.
现在参见图8和图9,钉仓(诸如钉仓1200)例如可包括可压缩的植入式仓体1210,该仓体包括外层1211和内层1212。与上文相似,钉仓1200可包括位于仓体1210内的多个钉1220。任选地,每个钉1220均可包括基部1222以及从其延伸的一个或多个钉腿1221。例如,钉腿1221可插入内层1212中并被坐置到例如使钉1220的基部1222邻接和/或邻近内层1212的底部表面1218定位的深度。在图8和图9中,内层1212不包括能够接收钉1220的一部分的钉腔,而作为另外一种选择,内层1212可包括此类钉腔。对上文进行进一步描述,内层1212可由能够允许仓体1210在对其施加压缩负载时塌缩的可压缩材料(诸如可生物吸收的泡沫和/或氧化再生纤维素(ORC))构成。内层1212可由例如包含聚乳酸(PLA)和/或聚乙醇酸(PGA)的冻干泡沫构成。ORC可以商品名Surgicel商购获得并且可包括松散的织造织物(像外科海绵一样)、松散的纤维(像棉球一样)和/或泡沫。内层1212可由其中包含和/或上面涂覆有药物(诸如冷冻干燥的凝血酶和/或血纤维蛋白)的材料构成,该药物例如可被患者体内的流体水活化和/或活化。例如,冷冻干燥的凝血酶和/或血纤维蛋白可保持在例如Vicryl(PGA)基质上。然而,在某些情况下,例如当钉仓1200被插入患者体内的手术部位中时,可活化的药物可被无意地活化。再次参见图8和图9,外层1211可由不透水的或至少基本上不透水的材料构成,使得液体不接触或至少基本上不接触内层1212,直到仓体1210已被压缩并且钉腿已穿透外层1211之后和/或外层1211已被以一些方式切割之后。例如,外层1211可由支撑物材料和/或塑性材料(诸如聚二氧杂环己酮(PDS)和/或聚乙醇酸(PGA))构成。外层1211可包括环绕内层1212和钉1220的包裹物。更具体地讲,钉1220可被插入内层1212和外层1211中并围绕包括内层1212和钉1220的子组件而被包裹并随后被密封。Referring now to FIGS. 8 and 9 , a staple cartridge, such as staple cartridge 1200 , for example, can include a compressible implantable cartridge body 1210 that includes an outer layer 1211 and an inner layer 1212 . Similar to the above, staple cartridge 1200 may include a plurality of staples 1220 within cartridge body 1210 . Optionally, each staple 1220 can include a base 1222 and one or more staple legs 1221 extending therefrom. For example, staple legs 1221 may be inserted into inner layer 1212 and seated to a depth such that bases 1222 of staples 1220 abut and/or are positioned adjacent bottom surface 1218 of inner layer 1212 . In FIGS. 8 and 9 , inner layer 1212 does not include staple cavities capable of receiving a portion of staples 1220 , while alternatively inner layer 1212 may include such staple cavities. Further to the above, the inner layer 1212 can be constructed of a compressible material capable of allowing the cartridge body 1210 to collapse when a compressive load is applied thereto, such as bioabsorbable foam and/or oxidized regenerated cellulose (ORC). The inner layer 1212 may be composed of, for example, a lyophilized foam comprising polylactic acid (PLA) and/or polyglycolic acid (PGA). ORCs are commercially available under the tradename Surgicel and may comprise loose woven fabric (like a surgical sponge), loose fibers (like cotton balls), and/or foam. The inner layer 1212 may be constructed of a material containing and/or coated thereon with a drug, such as freeze-dried thrombin and/or fibrin, that is activated and/or activated, for example, by fluid water in the patient's body. For example, lyophilized thrombin and/or fibrin can be maintained on a matrix such as Vicryl (PGA). However, under certain circumstances, such as when staple cartridge 1200 is inserted into a surgical site in a patient, the activatable drug may be unintentionally activated. Referring again to FIGS. 8 and 9 , the outer layer 1211 can be constructed of a water-impermeable or at least substantially water-impermeable material such that liquids do not contact or at least substantially do not contact the inner layer 1212 until the cartridge body 1210 has been compressed and the staple legs have been compressed. After the outer layer 1211 has been penetrated and/or after the outer layer 1211 has been cut in some way. For example, the outer layer 1211 may be composed of a support material and/or a plastic material such as polydioxanone (PDS) and/or polyglycolic acid (PGA). Outer layer 1211 may include a wrap surrounding inner layer 1212 and staples 1220 . More specifically, staples 1220 may be inserted into inner layer 1212 and outer layer 1211 and wrapped and then sealed around the subassembly including inner layer 1212 and staples 1220 .
如本文所述,当砧座运动到闭合位置时,钉仓的钉可由砧座完全成形。作为另外一种选择,现在参见图10-图13,诸如钉仓4100的钉仓的钉例如可通过当砧座运动到闭合位置时的砧座,以及另外通过使钉朝闭合的砧座运动的钉驱动器系统而变形。钉仓4100可包括可压缩的仓体4110,可压缩的仓体4110可例如由泡沫材料以及至少部分地位于可压缩仓体4110内的多个钉4120构成。钉驱动器系统可包括驱动器夹持器4160、定位在驱动器夹持器4160内的多个钉驱动器4162、以及钉仓盘4180,该钉仓盘能够将钉驱动器4162保持在驱动器夹持器4160中。例如,钉驱动器4162可定位在驱动器夹持器4160中的一个或多个狭槽4163内,其中狭槽4163的侧壁可帮助朝砧座向上引导钉驱动器4162。钉4120可由钉驱动器4162支撑在狭槽4163内,其中当钉4120和钉驱动器4162处于其未击发位置时,钉4120可完全定位在狭槽4163中。作为另外一种选择,当钉4120和钉驱动器4162处于其未击发位置时,钉4120的至少一部分可穿过狭槽4163的开口端4161向上延伸。例如,现在主要参见图11,钉4120的基部可被定位在驱动器夹持器4160内,并且钉4120的顶端可嵌入可压缩仓体4110内。钉4120的大约三分之一的高度可定位在驱动器夹持器4160内,并且钉4120的大约三分之二的高度可定位在仓体4110内。参见图10A,例如钉仓4100还可包括围绕仓体4110和驱动器夹持器4160的不透水包裹物或膜4111。As described herein, the staples of the staple cartridge can be fully formed by the anvil when the anvil is moved to the closed position. Alternatively, referring now to FIGS. 10-13 , the staples of a staple cartridge such as staple cartridge 4100 may, for example, pass through the anvil when the anvil moves to the closed position, and additionally by moving the staples toward the closed anvil. deformed by the nail driver system. The staple cartridge 4100 can include a compressible cartridge body 4110 which can be constructed, for example, from a foam material and a plurality of staples 4120 positioned at least partially within the compressible cartridge body 4110 . The staple driver system can include a driver holder 4160, a plurality of staple drivers 4162 positioned within the driver holder 4160, and a staple cartridge tray 4180 configured to retain the staple drivers 4162 in the driver holder 4160. For example, the staple drivers 4162 can be positioned within one or more slots 4163 in the driver holder 4160, wherein the sidewalls of the slots 4163 can help guide the staple drivers 4162 upwardly toward the anvil. Staples 4120 can be supported within slots 4163 by staple drivers 4162, wherein staples 4120 can be fully positioned in slots 4163 when staples 4120 and staple drivers 4162 are in their unfired positions. Alternatively, at least a portion of the staples 4120 can extend upwardly through the open ends 4161 of the slots 4163 when the staples 4120 and staple drivers 4162 are in their unfired positions. For example, referring primarily now to FIG. 11 , the bases of the staples 4120 can be positioned within the driver holder 4160 and the tips of the staples 4120 can be embedded within the compressible cartridge body 4110 . About one-third of the height of the staples 4120 can be positioned within the driver holder 4160 , and about two-thirds of the height of the staples 4120 can be positioned within the cartridge body 4110 . Referring to FIG. 10A , for example, staple cartridge 4100 can also include a water-impermeable wrap or membrane 4111 surrounding cartridge body 4110 and driver holder 4160 .
在使用中,例如,钉仓4100可位于钉仓通道内,并且砧座可朝钉仓4100运动到闭合位置。当砧座运动至其闭合位置时,砧座可接触并压缩可压缩的仓体4110。当砧座处于其闭合位置时,砧座可不接触钉4120。当砧座运动至其闭合位置时,砧座可接触钉4120的腿并且至少部分地使钉4120变形。在两种情形中的任一情形中,钉仓4100还可包括一个或多个橇4170,所述一个或多个橇可在钉仓4100内沿纵向推进,使得橇4170可随后接合钉驱动器4162并使钉驱动器4162及钉4120朝砧座运动。滑动件4170可在钉仓盘4180与钉驱动器4162之间滑动。在砧座的闭合已使钉4120的成形过程开始的情况下,钉4120朝砧座向上运动可完成成形过程并使钉4120变形至其完全成形的高度或至少期望的高度。在砧座的闭合未使钉4120变形的情况下,钉4120朝砧座向上运动可开始并完成成形过程并且使钉4120变形至其完全成形的高度或至少期望的高度。滑动件4170可从钉仓4100的近侧末端推进到钉仓4100的远侧末端,使得在定位于钉仓4100的远侧末端中的钉4120完全成形之前,定位于钉仓4100的近侧末端中的钉4120完全成形。参见图12,滑动件4170可各自包括至少一个成角度的或倾斜的表面4711,其能够在钉驱动器4162下方滑动并如图13所示提升钉驱动器4162。In use, for example, the staple cartridge 4100 can be positioned within the staple cartridge channel and the anvil can be moved toward the staple cartridge 4100 to the closed position. When the anvil is moved to its closed position, the anvil can contact and compress the compressible cartridge body 4110. The anvil may not contact the staples 4120 when the anvil is in its closed position. When the anvil is moved to its closed position, the anvil can contact the legs of the staples 4120 and at least partially deform the staples 4120. In either case, the staple cartridge 4100 can also include one or more sleds 4170 that can be advanced longitudinally within the staple cartridge 4100 such that the sleds 4170 can subsequently engage the staple drivers 4162 And the staple drivers 4162 and staples 4120 are moved toward the anvil. Slider 4170 is slidable between staple cartridge tray 4180 and staple drivers 4162 . Where the closing of the anvil has initiated the forming process of the staples 4120, upward movement of the staples 4120 toward the anvil can complete the forming process and deform the staples 4120 to their fully formed height, or at least a desired height. Without the closure of the anvil deforming the staples 4120, upward movement of the staples 4120 toward the anvil can initiate and complete the forming process and deform the staples 4120 to their fully formed height, or at least a desired height. The sled 4170 can be advanced from the proximal end of the staple cartridge 4100 to the distal end of the staple cartridge 4100 such that the staples 4120 positioned in the distal end of the staple cartridge 4100 are positioned at the proximal end of the staple cartridge 4100 before they are fully formed. The staples 4120 in are fully formed. Referring to FIG. 12 , sliders 4170 can each include at least one angled or sloped surface 4711 that can slide under staple drivers 4162 and lift staple drivers 4162 as shown in FIG. 13 .
对上文进行进一步描述,钉4120可被成形,以便将组织T的至少一部分和钉仓4100的可压缩仓体4110的至少一部分捕获在其中。在钉4120成形之后,外科缝合器的砧座及钉仓通道4130可远离已植入的钉仓4100运动。在各种情形中,仓盘4180可以固定方式接合钉仓通道4130,其中作为结果,当钉仓通道4130被拉离已植入的仓体4110时,仓盘4180可自可压缩的仓体4110拆卸。再次参见图10,仓盘4180可包括相对的侧壁4181,仓体4110能够可移除地定位在该相对的侧壁4181之间。例如,可压缩仓体4110可被压缩于侧壁4181之间,使得在使用期间仓体4110能够可移除地保持在其间,并且当仓盘4180被拉离时,仓体4110从仓盘4180可释放地脱离。例如,驱动器夹持器4160可连接到仓盘4180,使得当仓盘4180从手术部位移除时,驱动器保持器4160、驱动器4162和/或滑动件4170可保持在仓盘4180中。驱动器4162可从驱动器夹持器4160射出并且留在手术部位中。例如,驱动器4162可由可生物吸收的材料(诸如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚二氧杂环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL和/或PCL的复合物)构成。驱动器4162可附接到钉4120,使得驱动器4162部署有钉4120。例如,每个驱动器4162可包括例如能够接收钉4120的基部的槽,其中所述槽能够以压力配合方式和/或搭扣配合方式接收钉基部。Further to the above, the staples 4120 can be shaped to capture at least a portion of the tissue T and at least a portion of the compressible cartridge body 4110 of the staple cartridge 4100 therein. After staples 4120 are formed, the anvil of the surgical stapler and cartridge channel 4130 can be moved away from the implanted staple cartridge 4100 . In various circumstances, the cartridge tray 4180 can engage the staple cartridge channel 4130 in a fixed manner, wherein as a result, the cartridge tray 4180 can be disengaged from the compressible cartridge body 4110 when the staple cartridge channel 4130 is pulled away from the implanted cartridge body 4110 Disassemble. Referring again to FIG. 10 , the cartridge tray 4180 can include opposing side walls 4181 between which the cartridge body 4110 can be removably positioned. For example, the compressible cartridge body 4110 can be compressed between the side walls 4181 so that the cartridge body 4110 can be removably retained therebetween during use and when the cartridge tray 4180 is pulled away, the cartridge body 4110 is removed from the cartridge tray 4180. Releasably disengaged. For example, driver holder 4160 can be coupled to cartridge tray 4180 such that driver holder 4160, driver 4162, and/or slide 4170 can remain in cartridge tray 4180 when cartridge tray 4180 is removed from the surgical site. The driver 4162 can be ejected from the driver holder 4160 and left in the surgical site. For example, the driver 4162 can be made of a bioabsorbable material such as polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate, sold under the trade name Vicryl. (PHA), polycapron 25 (PGCL), polycaprolactone (PCL), and/or complexes of PGA, PLA, PDS, PHA, PGCL, and/or PCL sold under the tradename Monocryl). Driver 4162 can be attached to staple 4120 such that driver 4162 deploys staple 4120 . For example, each driver 4162 can include, for example, a slot configured to receive the base of a staple 4120, wherein the slot can receive the base of the staple in a press-fit and/or snap-fit manner.
对上文进行进一步描述,驱动器夹持器4160和/或滑动件4170可从仓盘4180射出。例如,滑动件4170可在仓盘4180与驱动器夹持器4160之间滑动,使得当滑动件4170推进以向上驱动钉驱动器4162和钉4120时,滑动件4170也可使驱动器夹持器4160向上运动到仓盘4180之外。例如,驱动器夹持器4160和/或滑动件4170可由可生物吸收的材料(诸如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚二氧杂环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL和/或PCL的复合物)构成。滑动件4170可整体地形成和/或附接到驱动棒或切割构件,所述驱动棒或切割构件穿过钉仓4100而推动滑动件4170。在这种情况下,滑动件4170可不从仓盘4180射出并且可与外科缝合器保持在一起,而在其中滑动件4170未附接到驱动棒的其他情况下,滑动件4170可留在手术部位中。在任何情形中,对上文进行进一步描述,仓体4110的可压缩性可容许在外科缝合器的端部执行器中使用较厚的钉仓,这是因为当缝合器的砧座闭合时,仓体4110可压缩或收缩。作为在砧座闭合时钉被至少部分地变形的结果,可使用较高的钉(诸如具有大约0.18"钉高度的钉),例如其中大约0.12"的钉高度可被定位在可压缩层4110中,并且其中可压缩层4110可具有大约0.14"的未压缩高度。Further to the above, the driver holder 4160 and/or the slide 4170 can be ejected from the cartridge tray 4180 . For example, the slider 4170 can slide between the cartridge tray 4180 and the driver holder 4160 such that when the slider 4170 is advanced to drive the staple drivers 4162 and the staples 4120 upward, the slider 4170 can also move the driver holder 4160 upwardly To warehouse 4180 outside. For example, the driver holder 4160 and/or slide 4170 may be made of a bioabsorbable material such as polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone ( PDS), polyhydroxyalkanoate (PHA), polycapron 25 (PGCL) sold under the tradename Monocryl, polycaprolactone (PCL), and/or PGA, PLA, PDS, PHA, PGCL and/or or a complex of PCL). The sled 4170 can be integrally formed and/or attached to a drive bar or cutting member that pushes the sled 4170 through the staple cartridge 4100 . In this case, the sled 4170 may not be ejected from the cartridge tray 4180 and may remain with the surgical stapler, whereas in other cases where the sled 4170 is not attached to the drive rod, the sled 4170 may remain at the surgical site middle. In any event, further to the above, the compressibility of the cartridge body 4110 can allow the use of thicker staple cartridges in the end effector of a surgical stapler because when the anvil of the stapler is closed, Cartridge body 4110 is compressible or collapsible. As a result of the staples being at least partially deformed when the anvil is closed, taller staples (such as staples having a staple height of about 0.18" can be used, for example, where a staple height of about 0.12" can be positioned in the compressible layer 4110 , and wherein the compressible layer 4110 can have an uncompressed height of about 0.14".
如本文所述,钉仓可在其中包括多个钉。任选地,此类钉可由被变形为基本上U形构型并具有两个钉腿的金属线材构成。可设想出其中钉可包括不同构型(诸如被接合在一起并具有三个或更多个钉腿的两个或更多个线材)的另选形式。用于形成钉的一个或多个线材可包括圆的或至少基本上圆的横截面。钉线材可包括任何其他合适的横截面,诸如正方形和/或矩形的横截面。钉可由塑料线材构成。钉可由涂覆有塑料的金属线材构成。根据本发明,除钉之外或作为钉的替代,仓可包括任何适合类型的紧固件。例如,这种紧固件可包括可枢转的臂,所述臂在被砧座接合时会被折叠。可使用两部分的紧固件。例如,钉仓可包括多个第一紧固件部,并且砧座可包括多个第二紧固件部;当砧座抵靠钉仓而被压缩时,第二紧固件部连接到第一紧固件部。如上所述,可在钉仓内推进滑动件或驱动器以便完成钉的成形过程。可在砧座内推进滑动件或驱动器,以便使一个或多个成形构件向下运动至与相对的钉仓和钉或定位在钉仓中的紧固件接合。As described herein, a staple cartridge can include a plurality of staples therein. Optionally, such staples may be constructed of metal wire deformed into a substantially U-shaped configuration with two staple legs. Alternatives are envisioned where the staple may comprise a different configuration, such as two or more wires joined together and having three or more staple legs. The one or more wires used to form the staple may comprise a round or at least substantially round cross-section. The staple wire may comprise any other suitable cross-section, such as a square and/or rectangular cross-section. The nails may consist of plastic wire. The nails may consist of metal wires coated with plastic. In accordance with the present invention, the cartridge may comprise any suitable type of fastener in addition to or instead of staples. For example, such fasteners may include pivotable arms that fold when engaged by the anvil. Two-part fasteners may be used. For example, the staple cartridge can include a plurality of first fastener portions, and the anvil can include a plurality of second fastener portions; when the anvil is compressed against the staple cartridge, the second fastener portions are connected to the first fastener portions. A fastener part. As noted above, the sled or driver can be advanced within the staple cartridge to complete the staple forming process. A slide or driver can be advanced within the anvil to move the one or more forming members downward into engagement with the opposing staple cartridge and staples or fasteners positioned in the staple cartridge.
如本文所述,钉仓可包括储存于其中的四个钉行。所述四个钉行可被设置成两个内侧钉行和两个外侧钉行。例如,内侧钉行和外侧钉行可被定位在钉仓内的切割构件或刀狭槽的第一侧上;相似地,内侧钉行和外侧钉行可被定位在切割构件或刀狭槽的第二侧上。钉仓可不包括切割构件狭槽;然而,作为钉仓狭槽的替代,这种钉仓可包括能够由切割构件切割的指定部分。相似地,可将内侧钉行布置在钉仓内,使得其与切割构件狭槽等距地或至少基本上等距地间隔开。相似地,可将各外侧钉排设置在钉仓内,使得其与切割构件狭槽等距地或至少基本上等距地间隔开。根据本发明,钉仓可包括储存在钉仓内的多于或少于四个钉行。钉仓可包括六个钉行。例如,钉仓可在切割构件狭槽的第一侧上包括三个钉行,并且在切割构件狭槽的第二侧上包括三个钉行。钉仓可包括奇数个钉行。例如,钉仓可在切割构件狭槽的第一侧上包括两个钉排,并且在切割构件狭槽的第二侧上包括三个钉排。钉排可包括具有相同或至少基本上相同的未成形钉高度的钉。作为另外一种选择,一个或多个钉行可包括具有与其他钉不同的未成形钉高度的钉。例如,切割构件狭槽的第一侧上的钉可具有第一未成形高度,并且切割构件狭槽的第二侧上的钉可具有第二未成形高度,该第二未成形高度不同于第一高度。As described herein, a staple cartridge can include four rows of staples stored therein. The four staple rows may be arranged as two inner staple rows and two outer staple rows. For example, the inner row of staples and the outer row of staples can be positioned on a first side of a cutting member or knife slot in the staple cartridge; on the second side. A staple cartridge may not include a cutting member slot; however, instead of a staple cartridge slot, such a staple cartridge may include a designated portion capable of being cut by the cutting member. Similarly, the inner rows of staples can be arranged within the staple cartridge such that they are spaced equidistantly, or at least substantially equidistantly, from the cutting member slots. Similarly, each outer row of staples can be positioned within the staple cartridge such that it is spaced equidistantly, or at least substantially equidistantly, from the cutting member slot. According to the present invention, a staple cartridge may include more or less than four rows of staples stored within the staple cartridge. The staple cartridge may include six staple rows. For example, the staple cartridge can include three rows of staples on a first side of the cutting member slot and three rows of staples on a second side of the cutting member slot. A staple cartridge may include an odd number of rows of staples. For example, the staple cartridge can include two rows of staples on a first side of the cutting member slot and three rows of staples on a second side of the cutting member slot. The rows of staples may comprise staples having the same, or at least substantially the same, unformed staple height. Alternatively, one or more rows of staples may include staples having a different unformed staple height than the other staples. For example, the staples on a first side of the cutting member slot can have a first unformed height, and the staples on a second side of the cutting member slot can have a second unformed height that is different from the first unformed height. a height.
任选地,如上所述,钉仓可包括仓体,该仓体包括多个限定在其中的钉腔。仓体可包括平台和顶部平台表面,其中每个钉腔可限定平台表面中的开口。还如上所述,钉可被定位在每个钉腔内,使得钉被储存在仓体内直到其从仓体被射出。在从仓体被射出之前,钉可被容纳在仓体内,使得钉不突起到平台表面上方。在此类情况下,当钉被定位在平台表面下方时,可减小钉被损坏和/或过早接触目标组织的可能性。在各种情况下,钉可在未击发位置和击发位置之间运动,在未击发位置中,其不从仓体突起,在击发位置中,其已从仓体露出并可接触被定位在钉仓对面的砧座。砧座和/或限定于砧座内的成形凹坑可被定位成距平台表面上方预定距离,使得当钉从仓体被部署时,钉变形至预定的成形高度。在一些情况下,被捕获在砧座和钉仓之间的组织的厚度可变化,因此,较厚的组织可被捕获在某些钉内而较薄的组织可被捕获在某些其他钉内。在任一种情况下,由钉施加到组织的夹紧压力或力例如可因钉而异,或在钉行的一端上的钉和钉行的另一端上的钉之间变化。在某些情况下,可控制砧座和钉仓平台之间的间隙,使得钉在每个钉内施加某一最小的夹紧压力。然而在一些此类情况下,在不同的钉内的夹紧压力的显著变化可能仍然存在。外科缝合器械在2008年6月3日公布的美国专利7,380,696中有所公开,该专利的全部公开内容以引用方式并入本文。用于外科缝合和切断器械的例证性多行程柄部在共同未决以及共同拥有的名称为“SURGICAL STAPLING INSTRUMENT INCORPORATING A MULTISTROKE FIRING POSITIONINDICATOR AND RETRACTION MECHANISM”的美国专利申请序列号10/374,026中进行了更详细的描述,该专利申请的公开内容据此全文以引用方式并入。符合本发明的其他应用可结合单击发行程,诸如在共同未决以及共同拥有的名称为“SURGICAL STAPLING INSTRUMENTHAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS”美国专利申请序列号10/441,632中所描述的,该专利申请的公开内容据此全文以引用方式并入。Optionally, as described above, the staple cartridge may include a cartridge body including a plurality of staple cavities defined therein. The cartridge body can include a deck and a top deck surface, wherein each staple cavity can define an opening in the deck surface. As also described above, staples can be positioned within each staple cavity such that the staples are stored within the cartridge body until they are ejected from the cartridge body. The staples may be contained within the cartridge body prior to being ejected from the cartridge body such that the staples do not protrude above the deck surface. In such cases, when the staples are positioned below the deck surface, the likelihood of the staples being damaged and/or prematurely contacting the target tissue can be reduced. In each case, the staple is movable between an unfired position, in which it does not protrude from the cartridge body, and a fired position, in which it has emerged from the cartridge body and is accessible to be positioned on the staple. The anvil opposite the bin. The anvil and/or forming pockets defined within the anvil may be positioned a predetermined distance above the deck surface such that when the staples are deployed from the cartridge body, the staples deform to a predetermined formed height. In some cases, the thickness of the tissue captured between the anvil and the staple cartridge can vary, so that thicker tissue can be captured within some staples and thinner tissue can be captured within certain other staples . In either case, the clamping pressure or force applied to the tissue by the staples may vary, for example, from staple to staple, or between staples on one end of a row of staples and staples on the other end of a row of staples. In some cases, the gap between the anvil and the cartridge deck can be controlled such that the staples exert some minimum clamping pressure within each staple. In some such cases, however, significant variation in clamping pressure within different staples may still exist. Surgical stapling instruments are disclosed in US Patent 7,380,696, issued June 3, 2008, the entire disclosure of which is incorporated herein by reference. An illustrative multi-stroke handle for a surgical stapling and severing instrument is modified in co-pending and commonly owned U.S. Patent Application Serial No. 10/374,026, entitled "SURGICAL STAPLING INSTRUMENT INCORPORATING A MULTISTROKE FIRING POSITION INDICATOR AND RETRACTION MECHANISM." detailed description, the disclosure of this patent application is hereby incorporated by reference in its entirety. Other applications consistent with the present invention may incorporate single-shot triggering, such as that described in co-pending and commonly owned U.S. Patent Application Serial No. The disclosure of the application is hereby incorporated by reference in its entirety.
如本文所述,钉仓可包括如下装置:该装置用于对捕获在被从钉仓部署的钉内的组织的厚度进行补偿。参见图14,钉仓(诸如钉仓10000)例如可包括刚性的第一部分(诸如支撑部分10010)以及可压缩的第二部分(诸如组织厚度补偿件10020)。首先参见图16,支撑部分10010可包括仓体、顶部平台表面10011和多个钉腔10012,其中类似于上文所述,每个钉腔10012可限定平台表面10011中的开口。钉10030例如可被可移除地定位在每个钉腔10012中。例如,每个钉10030可包括基部10031以及从基部10031延伸的一个或多个腿10032。在钉10030被部署之前,还如下文更详细所述,钉10030的基部10031可由定位在支撑部分10010内的钉驱动器支撑,并且同时,钉10030的腿10032可至少被部分容纳在钉腔10012内。钉10030可在未击发位置和击发位置之间被部署,使得腿10032运动穿过组织厚度补偿件10020,穿透组织厚度补偿件10020的顶部表面,穿透组织T,并且接触被定位在钉仓10000对面的砧座。当腿10032抵靠砧座变形时,每个钉10030的腿10032可捕获组织厚度补偿件10020的一部分以及每个钉10030内的组织T的一部分,并且将压缩力施加到组织。对上文进行进一步描述,可使每个钉10030的腿10032向下朝钉的基部10031变形,以形成钉截留区域10039,在该钉截留区域,组织T和组织厚度补偿件10020可被捕获。在各种情况下,钉截留区域10039可被限定在已变形的腿10032的内表面和基部10031的内表面之间。钉截留区域的尺寸可取决于若干因素,例如腿的长度、腿的直径、基部的宽度、和/或例如腿变形的程度。As described herein, a staple cartridge may include means for compensating for the thickness of tissue trapped within staples deployed from the staple cartridge. 14, a staple cartridge, such as staple cartridge 10000, for example, can include a rigid first portion, such as support portion 10010, and a compressible second portion, such as tissue thickness compensator 10020. Referring first to FIG. 16 , the support portion 10010 can include a cartridge body, a top deck surface 10011 and a plurality of staple cavities 10012 , wherein each staple cavity 10012 can define an opening in the deck surface 10011 similar to that described above. Staples 10030 can be removably positioned within each staple cavity 10012, for example. For example, each staple 10030 can include a base 10031 and one or more legs 10032 extending from the base 10031 . Prior to the staples 10030 being deployed, as also described in more detail below, the bases 10031 of the staples 10030 can be supported by staple drivers positioned within the support portion 10010 and, at the same time, the legs 10032 of the staples 10030 can be at least partially received within the staple cavities 10012 . The staples 10030 can be deployed between an unfired position and a fired position such that the legs 10032 move through the tissue thickness compensator 10020, penetrate the top surface of the tissue thickness compensator 10020, penetrate the tissue T, and contact is positioned at the staple cartridge. 10000 opposite the anvil. When the legs 10032 are deformed against the anvil, the legs 10032 of each staple 10030 can capture a portion of the tissue thickness compensator 10020 and a portion of the tissue T within each staple 10030 and apply a compressive force to the tissue. Further to the above, the legs 10032 of each staple 10030 can be deformed downwardly toward the base 10031 of the staple to form a staple entrapment region 10039 where the tissue T and tissue thickness compensator 10020 can be captured. In various circumstances, a staple entrapment region 10039 can be defined between the inner surface of the deformed leg 10032 and the inner surface of the base 10031 . The size of the staple entrapment area may depend on several factors, such as the length of the legs, the diameter of the legs, the width of the base, and/or the degree of deformation of the legs, for example.
以前,外科医生常常需要针对要缝合的组织选择具有适当钉高度的合适的钉。例如,外科医生可选择高的钉与厚组织一起使用以及选择低的钉与薄组织一起使用。然而在一些情况下,正被缝合的组织不具有一致的厚度,因此,一些钉无法实现期望的击发构型。例如,图48示出了用于薄组织中的高的钉。现在参见图49,当组织厚度补偿件(诸如组织厚度补偿件10020)例如与薄组织一起使用时,例如较大的钉可成形为期望的击发构型。Previously, surgeons often needed to select the proper staple with the proper staple height for the tissue to be stapled. For example, a surgeon may select tall staples for use with thick tissue and low staples for use with thin tissue. In some cases, however, the tissue being stapled does not have a consistent thickness and, therefore, some staples fail to achieve the desired firing configuration. For example, Figure 48 shows tall staples used in thin tissue. Referring now to FIG. 49, when a tissue thickness compensator, such as tissue thickness compensator 10020, is used, for example, with thin tissue, larger staples, for example, can be shaped into a desired firing configuration.
由于组织厚度补偿件的压缩率,组织厚度补偿件可对捕获在每个钉内的组织的厚度进行补偿。更具体地讲,现在参见图43和图44,组织厚度补偿件(诸如组织厚度补偿件10020)例如可根据钉截留区域10039内容纳的组织的厚度和/或类型来占据每个钉10030的钉截留区域10039的较大和/或较小的部分。例如,在较厚的组织T被捕获在钉10030内的情况下,如果较薄的组织T被捕获在钉10030内,则组织厚度补偿件10020可占据钉截留区域10039的较大部分。相应地,相较于较薄的组织T被捕获在钉10030内的情况,如果较厚的组织T被捕获在钉10030内,则组织厚度补偿件10020可占据钉截留区域10039的较小部分。这样,组织厚度补偿件可补偿较薄组织和/或较厚组织,并确保压缩力被施加到组织,而不论或至少基本上不论被捕获在钉内的组织厚度如何。除了上文所述之外,组织厚度补偿件10020可对被捕获在不同钉10030内的不同类型或不同压缩率的组织进行补偿。现在参见图44,组织厚度补偿件10020可将压缩力施加到可包括血管V的血管组织T,并因此限制血液流过不太可压缩的血管V,但是仍然将期望的压缩力施加到周围的组织T。在各种情况下,对上文进行进一步描述,组织厚度补偿件10020还可补偿已变形的钉。参见图45,各种钉10030的变形可导致限定在此类钉内的较大的钉截留区域10039。由于组织厚度补偿件10020的回弹力,现在参见图46,即使被限定在这种已变形钉10030内的钉截留区域10039可被扩大,定位在已变形钉10030内的组织厚度补偿件10020仍然可将足够的压缩压力施加到组织T。在各种情况下,位于相邻钉10030中间的组织厚度补偿件10020可被已变形钉10030周围的适当成形的钉10030抵靠组织T偏置,并因此将压缩压力施加到例如围绕和/或被捕获在已变形钉10030内的组织。在各种情况下,组织厚度补偿件可补偿不同的组织密度,所述不同的组织密度可例如由于钙化、纤维区域、和/或先前已缝合或处理的组织而产生。Due to the compressibility of the tissue thickness compensator, the tissue thickness compensator can compensate for the thickness of the tissue captured within each staple. More specifically, referring now to FIGS. 43 and 44 , a tissue thickness compensator, such as tissue thickness compensator 10020 , can occupy the staples of each staple 10030 , for example, depending on the thickness and/or type of tissue received within staple entrapment region 10039 . Larger and/or smaller portions of the entrapment area 10039. For example, where thicker tissue T is captured within the staples 10030, the tissue thickness compensator 10020 can occupy a greater portion of the staple entrapment area 10039 if thinner tissue T is captured within the staples 10030. Accordingly, the tissue thickness compensator 10020 may occupy a smaller portion of the staple entrapment area 10039 if thicker tissue T is captured within the staple 10030 than if thinner tissue T is captured within the staple 10030 . In this manner, the tissue thickness compensator can compensate for thinner tissue and/or thicker tissue and ensure that compressive forces are applied to the tissue regardless, or at least substantially regardless, of the thickness of the tissue captured within the staples. In addition to the above, the tissue thickness compensator 10020 can compensate for different types or different rates of compression of tissue captured within different staples 10030 . Referring now to FIG. 44, a tissue thickness compensator 10020 can apply a compressive force to vascular tissue T, which can include a blood vessel V, and thus restrict blood flow through the less compressible blood vessel V, but still apply a desired compressive force to the surrounding Organization T. In various circumstances, further to the above, the tissue thickness compensator 10020 can also compensate for deformed staples. Referring to Fig. 45, deformation of various staples 10030 can result in larger staple entrapment regions 10039 defined within such staples. Due to the resiliency of the tissue thickness compensator 10020, referring now to FIG. 46, even though the staple entrapment region 10039 defined within such a deformed staple 10030 can be enlarged, the tissue thickness compensator 10020 positioned within the deformed staple 10030 can still Sufficient compressive pressure is applied to the tissue T. In various instances, the tissue thickness compensator 10020 intermediate adjacent staples 10030 can be biased against the tissue T by suitably shaped staples 10030 around the deformed staples 10030 and thus apply compressive pressure, for example, around and/or Tissue captured within deformed staples 10030. In various cases, the tissue thickness compensator can compensate for different tissue densities that can result, for example, from calcifications, fibrous regions, and/or previously sutured or treated tissue.
根据本发明,固定的或不可改变的组织间隙可被限定在支撑部分和砧座之间,因此不论被捕获在钉内的组织的厚度为何均可使钉变形至预定的高度。当组织厚度补偿件用于此类情况时,组织厚度补偿件可适应被捕获在砧座和支撑部分钉仓之间的组织,并且由于组织厚度补偿件的回弹力,组织厚度补偿件可将附加的压缩压力施加到组织。现在参见图50-图55,钉10030已成形为预定义的高度H。参照图50,组织厚度补偿件未被使用,并且组织T占据了整个钉截留区域10039。参照图57,组织厚度补偿件10020的一部分已被捕获在钉10030内,已将组织T压缩,并且已占据钉截留区域10039的至少一部分。现在参见图52,薄组织T已被捕获在钉10030内。在该实施例中,被压缩的组织T具有大约2/9H的高度,并且被压缩的组织厚度补偿件10020具有例如大约7/9H的高度。现在参见图53,具有中间厚度的组织T已被捕获在钉10030内。在该实施例中,被压缩的组织T具有大约4/9H的高度,并且被压缩的组织厚度补偿件10020具有例如大约5/9H的高度。现在参见图54,具有中间厚度的组织T已被捕获在钉10030内。在该实施例中,被压缩的组织T具有大约2/3H的高度,并且被压缩的组织厚度补偿件10020具有例如大约1/3H的高度。现在参见图53,厚组织T已被捕获在钉10030内。在该实施例中,被压缩的组织T具有大约8/9H的高度,并且被压缩的组织厚度补偿件10020具有例如大约1/9H的高度。在各种情况下,组织厚度补偿件可包括压缩高度,该压缩高度包括:例如大约10%的钉截留高度、大约20%的钉截留高度、大约30%的钉截留高度、大约40%的钉截留高度、大约50%的钉截留高度、大约60%的钉截留高度、大约70%的钉截留高度、大约80%的钉截留高度、和/或大约90%的钉截留高度。According to the present invention, a fixed or unchangeable tissue gap can be defined between the support portion and the anvil, thereby deforming the staple to a predetermined height regardless of the thickness of the tissue captured within the staple. When a tissue thickness compensator is used in such situations, the tissue thickness compensator can accommodate the tissue captured between the anvil and the support portion of the cartridge, and due to the resiliency of the tissue thickness compensator, the tissue thickness compensator can hold the additional of compressive pressure applied to the tissue. Referring now to FIGS. 50-55 , the staples 10030 have been formed to a predefined height H. As shown in FIG. Referring to FIG. 50 , the tissue thickness compensator is not used and tissue T occupies the entire staple entrapment area 10039 . Referring to FIG. 57 , a portion of the tissue thickness compensator 10020 has been captured within the staples 10030 , has compressed the tissue T, and has occupied at least a portion of the staple entrapment region 10039 . Referring now to FIG. 52 , thin tissue T has been captured within staples 10030 . In this embodiment, the compressed tissue T has a height of about 2/9H, and the compressed tissue thickness compensator 10020 has a height of, for example, about 7/9H. Referring now to FIG. 53 , tissue T having an intermediate thickness has been captured within staples 10030 . In this embodiment, the compressed tissue T has a height of about 4/9H, and the compressed tissue thickness compensator 10020 has a height of, for example, about 5/9H. Referring now to FIG. 54 , tissue T having an intermediate thickness has been captured within staples 10030 . In this embodiment, the compressed tissue T has a height of about 2/3H, and the compressed tissue thickness compensator 10020 has a height of, for example, about 1/3H. Referring now to FIG. 53 , thick tissue T has been captured within staples 10030 . In this embodiment, the compressed tissue T has a height of about 8/9H, and the compressed tissue thickness compensator 10020 has a height of, for example, about 1/9H. In various cases, the tissue thickness compensator can comprise a compressed height comprising, for example, about 10% staple entrapment height, about 20% staple entrapment height, about 30% staple entrapment height, about 40% staple entrapment height Staple retention height, approximately 50% staple retention height, approximately 60% staple retention height, approximately 70% staple retention height, approximately 80% staple retention height, and/or approximately 90% staple retention height.
钉10030可包括任何合适的未成形高度。钉10030可包括例如介于大约2mm和大约4.8mm之间的未成形高度。钉10030可包括例如大约2.0mm、大约2.5mm、大约3.0mm、大约3.4mm、大约3.5mm、大约3.8mm、大约4.0mm、大约4.1mm、和/或大约4.8mm的未成形高度。钉可变形至的高度H可由支撑部分10010的平台表面10011和相对的砧座之间的距离来决定。平台表面10011和砧座的组织接触表面之间的距离可例如为大约0.097"。高度H还可由限定在砧座内的成形凹坑的深度决定。成形凹坑例如可具有从组织接触表面测量的深度。任选地,如下文更详细所述,钉仓10000还可包括钉驱动器,该钉驱动器可将钉10030朝砧座抬起,并且将钉抬起或“过度驱动”到平台表面10011上方。在这种情况下,钉10030的成形高度H还可由钉10030被过度驱动的距离来决定。例如,钉10030可被过度驱动例如大约.028",并且可导致钉10030被成形为例如大约0.189"的高度。钉10030可被成形为例如大约0.8mm、大约1.0mm、大约1.5mm、大约1.8mm、大约2.0mm、和/或大约2.25mm的高度。钉可被成形为例如介于大约2.25mm和大约3.0mm之间的高度。对上文进行进一步描述,钉的钉截留区域的高度可由钉的成形高度以及包括钉的线材的宽度和直径所决定。钉10030的钉截留区域10039的高度可包括钉的成形高度H减去线材的两个直径宽度。钉线可包括例如大约0.0089"的直径。钉线可包括例如介于大约0.0069"和大约0.0119"之间的直径。例如,钉10030的成形高度H可为大约0.189",并且钉线直径可为大约0.0089",从而例如产生大约0.171"的钉截留高度。Staples 10030 can comprise any suitable unformed height. Staples 10030 can include, for example, an unformed height of between about 2 mm and about 4.8 mm. The staples 10030 can include, for example, an unformed height of about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.4 mm, about 3.5 mm, about 3.8 mm, about 4.0 mm, about 4.1 mm, and/or about 4.8 mm. The height H to which the staples can be deformed can be determined by the distance between the deck surface 10011 of the support portion 10010 and the opposing anvil. The distance between the platform surface 10011 and the tissue-contacting surface of the anvil can be, for example, about 0.097". The height H can also be determined by the depth of the forming pocket defined in the anvil. The forming pocket, for example, can have a diameter measured from the tissue-contacting surface. Depth. Optionally, as described in more detail below, the staple cartridge 10000 can also include a staple driver that can lift the staples 10030 toward the anvil and lift or "overdrive" the staples above the deck surface 10011 In this case, the formed height H of the staples 10030 can also be determined by the distance by which the staples 10030 are overdriven. For example, the staples 10030 can be overdriven, for example, by about .028", and can result in the staples 10030 being formed, for example, by about 0.189" The height of ". Staple 10030 can be shaped as, for example, about 0.8 mm, about 1.0 mm, about 1.5 mm, about 1.8 mm, about 2.0 mm, and/or about 2.25 mm in height. Staples can be shaped, for example, between about 2.25" A height between mm and about 3.0 mm. Further to the above, the height of the staple entrapment region of the staple may be determined by the formed height of the staple and the width and diameter of the wire comprising the staple. The height of the staple entrapment region 10039 of the staple 10030 The formed height H of the staple can be included minus the two diameter widths of the wire. The staple wire can include a diameter of, for example, approximately 0.0089". The staple line can comprise, for example, a diameter between about 0.0069" and about 0.0119". For example, the formed height H of the staples 10030 can be about 0.189", and the staple wire diameter can be about 0.0089", resulting in a staple retention height of about 0.171", for example.
对上文进行进一步描述,组织厚度补偿件可包括未压缩的或预部署的高度,并且能够变形为多个压缩高度中的一个。组织厚度补偿件可包括例如大约0.125"的未压缩高度。组织厚度的补偿件可包括例如大于等于大约0.080"的未压缩高度。组织厚度补偿件可包括未压缩的或预部署的高度,该高度大于钉的未击发高度。组织厚度补偿件的未压缩的或预部署的高度可比钉的未击发高度例如高大约10%、高大约20%、高大约30%、高大约40%、高大约50%、高大约60%、高大约70%、高大约80%、高大约90%、和/或高大约100%。组织厚度补偿件的未压缩的或预部署的高度可比钉的未击发高度高例如至多大约100%。组织厚度补偿件的未压缩的或预部署的高度可比钉的未击发高度高例如超过100%。组织厚度补偿件可包括等于钉的未击发高度的未压缩高度。组织厚度补偿件可包括小于钉的未击发高度的未压缩高度。组织厚度补偿件的未压缩的或预部署的高度可比钉的未击发高度例如低大约10%、低大约20%、低大约30%、低大约40%、低大约50%、低大约60%、低大约70%、低大约80%、和/或低大约90%。可压缩的第二部分可包括未压缩高度,该未压缩高度高于正被缝合的组织T的未压缩高度。组织厚度补偿件可包括未压缩高度,该未压缩高度等于正被缝合的组织T的未压缩高度。组织厚度补偿件可包括未压缩高度,该未压缩高度低于正被缝合的组织T的未压缩高度。Further to the above, the tissue thickness compensator may comprise an uncompressed or pre-deployed height and be deformable to one of a plurality of compressed heights. The tissue thickness compensator can include, for example, an uncompressed height of about 0.125". The tissue thickness compensator can include, for example, an uncompressed height of about 0.080" or greater. The tissue thickness compensator can include an uncompressed or pre-deployed height that is greater than the unfired height of the staples. The uncompressed or pre-deployed height of the tissue thickness compensator may be about 10%, about 20% higher, about 30% higher, about 40% higher, about 50% higher, about 60% higher, for example, than the unfired height of the staples. About 70% higher, about 80% higher, about 90% higher, and/or about 100% higher. The uncompressed or pre-deployed height of the tissue thickness compensator may be, for example, up to about 100% higher than the unfired height of the staples. The uncompressed or pre-deployed height of the tissue thickness compensator may be greater than, for example, more than 100% of the unfired height of the staples. The tissue thickness compensator can include an uncompressed height equal to the unfired height of the staples. The tissue thickness compensator can include an uncompressed height that is less than the unfired height of the staples. The uncompressed or pre-deployed height of the tissue thickness compensator may be, for example, about 10%, about 20% lower, about 30% lower, about 40% lower, about 50% lower, about 60% lower, or about 60% lower than the unfired height of the staples. About 70% lower, about 80% lower, and/or about 90% lower. The compressible second portion may include an uncompressed height that is higher than the uncompressed height of the tissue T being stapled. The tissue thickness compensator may include an uncompressed height equal to the uncompressed height of the tissue T being stapled. The tissue thickness compensator may include an uncompressed height that is lower than the uncompressed height of the tissue T being stapled.
如上所述,不论是厚组织还是薄组织被捕获在钉内,组织厚度补偿件均可在多个成形钉内被压缩。例如,可使钉线或钉行内的钉变形,使得每个钉的钉截留区域包括例如大约2.0mm的高度,其中组织T和组织厚度补偿件可被压缩到该高度内。在某些情况下,组织T可包括在钉截留区域内的大约1.75mm的压缩高度,而组织厚度补偿件可包括在钉截留区域内的大约0.25mm的压缩高度,从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情况下,组织T可包括在钉截留区域内的大约1.50mm的压缩高度,而组织厚度补偿件可包括在钉截留区域内的大约0.50mm的压缩高度,从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情况下,组织T可包括在钉截留区域内的大约1.25mm的压缩高度,而组织厚度补偿件可包括在钉截留区域内的大约0.75mm的压缩高度,从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情况下,组织T可包括在钉截留区域内的大约1.0mm的压缩高度,而组织厚度补偿件可包括在钉截留区域内的大约1.0mm的压缩高度,从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情况下,组织T可包括在钉截留区域内的大约0.75mm的压缩高度,而组织厚度补偿件可包括在钉截留区域内的大约1.25mm的压缩高度,从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情况下,组织T可包括在钉截留区域内的大约1.50mm的压缩高度,而组织厚度补偿件可包括在钉截留区域内的大约0.50mm的压缩高度,从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情况下,组织T可包括在钉截留区域内的大约0.25mm的压缩高度,而组织厚度补偿件可包括在钉截留区域内的大约1.75mm的压缩高度,从而得到总计为例如大约2.0mm的钉截留区域高度。As noted above, the tissue thickness compensator can be compressed within a plurality of formed staples regardless of whether thick or thin tissue is captured within the staples. For example, the staples within a staple line or row can be deformed such that the staple entrapment region of each staple includes a height of, for example, about 2.0 mm into which the tissue T and tissue thickness compensator can be compressed. In some cases, the tissue T can include a compressed height of about 1.75 mm in the staple entrapment region, and the tissue thickness compensator can include a compressed height of about 0.25 mm in the staple entrapment region, resulting in a total of, for example, about 2.0 mm. The height of the nail entrapment zone in mm. In some cases, the tissue T can include a compressed height of about 1.50 mm in the staple entrapment region, and the tissue thickness compensator can include a compressed height of about 0.50 mm in the staple entrapment region, resulting in a total of, for example, about 2.0 mm. The height of the nail entrapment zone in mm. In some cases, the tissue T can include a compressed height of about 1.25 mm in the staple entrapment region, and the tissue thickness compensator can include a compressed height of about 0.75 mm in the staple entrapment region, resulting in a total of, for example, about 2.0 mm. The height of the nail entrapment zone in mm. In some cases, the tissue T can include a compressed height of about 1.0 mm in the staple entrapment region, and the tissue thickness compensator can include a compressed height of about 1.0 mm in the staple entrapment region, resulting in a total of, for example, about 2.0 mm. The height of the nail entrapment zone in mm. In some cases, the tissue T can include a compressed height of about 0.75 mm in the staple entrapment region, and the tissue thickness compensator can include a compressed height of about 1.25 mm in the staple entrapment region, resulting in a total of, for example, about 2.0 mm. The height of the nail entrapment zone in mm. In some cases, the tissue T can include a compressed height of about 1.50 mm in the staple entrapment region, and the tissue thickness compensator can include a compressed height of about 0.50 mm in the staple entrapment region, resulting in a total of, for example, about 2.0 mm. The height of the nail entrapment zone in mm. In some cases, the tissue T can include a compressed height of about 0.25 mm in the staple entrapment region, and the tissue thickness compensator can include a compressed height of about 1.75 mm in the staple entrapment region, resulting in a total of, for example, about 2.0 mm. The height of the nail entrapment zone in mm.
对上文进行进一步描述,组织厚度补偿件可包括小于钉的击发高度的未压缩高度。组织厚度补偿件可包括等于钉的击发高度的未压缩高度。组织厚度补偿件可包括高于钉的击发高度的未压缩高度。例如,组织厚度补偿件的未压缩高度可包括例如如下厚度:该厚度为成形钉高度的大约110%、成形钉高度的大约120%、成形钉高度的大约130%、成形钉高度的大约140%、成形钉高度的大约150%、成形钉高度的大约160%、成形钉高度的大约170%、成形钉高度的大约180%、成形钉高度的大约190%、和/或成形钉高度的大约200%。组织厚度补偿件可包括未压缩高度,该高度为钉的击发高度的两倍以上。组织厚度补偿件可包括压缩高度,该高度为例如成形钉高度的大约85%至大约150%。任选地,如上所述,组织厚度补偿件可被压缩成介于未压缩厚度和压缩厚度之间。组织厚度补偿件的压缩厚度可例如为其未压缩厚度的大约10%、其未压缩厚度的大约20%、其未压缩厚度的大约30%、其未压缩厚度的大约40%、其未压缩厚度的大约50%、其未压缩厚度的大约60%、其未压缩厚度的大约70%、其未压缩厚度的大约80%、和/或其未压缩厚度的大约90%。组织厚度补偿件的未压缩厚度可例如比其压缩厚度厚大约两倍、大约十倍、大约五十倍、和/或大约一百倍。组织厚度补偿件的压缩厚度可介于其未压缩厚度的大约60%至大约99%。组织厚度补偿件的未压缩厚度可比其压缩厚度厚至少50%。组织厚度补偿件的未压缩厚度可比其压缩厚度厚至多一百倍。可压缩的第二部分可为弹性的,或至少部分弹性的,并且可将组织T抵靠钉的变形腿偏置。例如,可压缩的第二部分可在组织T和钉的基部之间弹性膨胀,以便抵靠钉的腿推动组织T。如下文将进一步详细讨论,组织厚度补偿件可被定位在组织T和变形的钉腿中间。在各种情况下,由于上文所述,组织厚度补偿件能够消除钉截留区域内的任何间隙。Further to the above, the tissue thickness compensator may comprise an uncompressed height that is less than the fired height of the staples. The tissue thickness compensator can include an uncompressed height equal to the fired height of the staples. The tissue thickness compensator can include an uncompressed height above the fired height of the staples. For example, the uncompressed height of the tissue thickness compensator can include, for example, a thickness of about 110% of the height of the formed staples, about 120% of the height of the formed staples, about 130% of the height of the formed staples, about 140% of the height of the formed staples , about 150% of the height of the formed staples, about 160% of the height of the formed staples, about 170% of the height of the formed staples, about 180% of the height of the formed staples, about 190% of the height of the formed staples, and/or about 200% of the height of the formed staples %. The tissue thickness compensator can include an uncompressed height that is more than twice the fired height of the staples. The tissue thickness compensator can include a compressed height that is, for example, about 85% to about 150% of the height of the formed staples. Optionally, as described above, the tissue thickness compensator can be compressed between an uncompressed thickness and a compressed thickness. The compressed thickness of the tissue thickness compensator can be, for example, about 10% of its uncompressed thickness, about 20% of its uncompressed thickness, about 30% of its uncompressed thickness, about 40% of its uncompressed thickness, about about 50% of its uncompressed thickness, about 60% of its uncompressed thickness, about 70% of its uncompressed thickness, about 80% of its uncompressed thickness, and/or about 90% of its uncompressed thickness. The uncompressed thickness of the tissue thickness compensator can be, for example, about two times, about ten times, about fifty times, and/or about one hundred times thicker than its compressed thickness. The compressed thickness of the tissue thickness compensator may be between about 60% and about 99% of its uncompressed thickness. The uncompressed thickness of the tissue thickness compensator can be at least 50% thicker than its compressed thickness. The uncompressed thickness of the tissue thickness compensator may be up to one hundred times thicker than its compressed thickness. The compressible second portion may be elastic, or at least partially elastic, and may bias the tissue T against the deformed legs of the staples. For example, the compressible second portion can elastically expand between the tissue T and the base of the staple so as to push the tissue T against the legs of the staple. As will be discussed in further detail below, the tissue thickness compensator can be positioned intermediate the tissue T and the deformed staple legs. In each case, due to the above, the tissue thickness compensator is able to eliminate any gaps in the staple entrapment area.
组织厚度补偿件可包含特征在于以下特性中的一者或多者的材料:例如,生物相容性、生物吸收性、生物再吸收性、生物耐久性、生物降解性、可压缩性、流体可吸收性、溶胀性、自膨胀性、生物活性、药物性、药物活性、抗粘合性、止血性、抗生素性、抗菌性、抗病毒性、营养性、粘附性、渗透性、亲水性和/或疏水性。根据本发明,包括砧座和钉仓的外科器械可包括与砧座和/或钉仓相关联的组织厚度补偿件,其包含止血剂(诸如血纤维蛋白和凝血酶)、抗生素(诸如doxycpl)和药物(诸如基质金属蛋白酶(MMPs))中的至少一者。The tissue thickness compensator may comprise a material characterized by one or more of the following properties: e.g., biocompatibility, bioabsorbability, bioresorbability, biodurability, biodegradability, compressibility, fluid Absorption, swelling, self-expansion, bioactivity, drug, drug activity, anti-adhesion, hemostatic, antibiotic, antibacterial, antiviral, nutritional, adhesive, penetrative, hydrophilic and/or hydrophobicity. In accordance with the present invention, a surgical instrument comprising an anvil and a staple cartridge may include a tissue thickness compensator associated with the anvil and/or staple cartridge comprising hemostatic agents such as fibrin and thrombin, antibiotics such as doxycpl and at least one of drugs such as matrix metalloproteinases (MMPs).
组织厚度补偿件可包括合成和/或非合成材料。组织厚度补偿件可包括聚合物组合物,所述聚合物组合物包括一种或多种合成聚合物和/或一种或多种非合成聚合物。合成聚合物可包括合成的可吸收聚合物和/或合成的非可吸收聚合物。聚合物组合物可包括例如生物相容性泡沫。生物相容性泡沫可包括例如多孔的开孔泡沫和/或多孔的闭孔泡沫。生物相容性泡沫可具有均匀的孔形态或可具有梯度孔形态(即,在一个方向在整个泡沫厚度上,小孔尺寸逐渐增加变成大孔)。聚合物组合物可包括多孔支架、多孔基质、凝胶基质、水凝胶基质、溶液基质、丝状基质、管状基质、复合基质、膜基质、生物稳定聚合物和可生物降解的聚合物中的一种或多种、以及它们的组合。例如,组织厚度补偿件可包括通过丝状基质增强的泡沫,或可包括具有附加的水凝胶层的泡沫,该附加的水凝胶层在体液存在下膨胀,以在组织上进一步提供压缩。根据本发明,组织厚度补偿件还可由材料和/或第二层或第三层上的涂层构成,该涂层在体液的存在下膨胀,以在组织上进一步提供压缩。此类层可为水凝胶,该水凝胶可为合成的和/或天然源材料,并且例如可为生物耐用的和/或可生物降解的。组织厚度补偿件可包括微凝胶或纳米凝胶。水凝胶可包括来自碳水化合物的微凝胶和/或纳米凝胶。可使用能提供附加柔韧性、刚度、和/或强度的纤维非织造材料或纤维网眼类型元件来增强组织厚度补偿件。根据本发明,组织厚度补偿件具有多孔形态,该多孔形态表现出梯度结构,例如在一个表面上的小孔以及在另一个表面上的较大的孔。此类形态对于组织生长或止血行为而言更为理想。此外,梯度还可与变化的生物吸收剖面相组合。短期吸收剖面可为优选的,以解决止血问题,而长期吸收剖面可解决无渗漏情况下使组织更好愈合的问题。The tissue thickness compensator may comprise synthetic and/or non-synthetic materials. The tissue thickness compensator may comprise a polymer composition comprising one or more synthetic polymers and/or one or more non-synthetic polymers. Synthetic polymers may include synthetic absorbable polymers and/or synthetic non-absorbable polymers. A polymer composition can include, for example, a biocompatible foam. Biocompatible foams may include, for example, porous open-cell foams and/or porous closed-cell foams. Biocompatible foams may have a uniform cell morphology or may have a gradient cell morphology (ie, gradually increasing in size from small cells to large cells in one direction throughout the thickness of the foam). The polymer composition may include porous scaffolds, porous matrices, gel matrices, hydrogel matrices, solution matrices, filamentous matrices, tubular matrices, composite matrices, membrane matrices, biostable polymers, and biodegradable polymers. One or more, and combinations thereof. For example, a tissue thickness compensator may comprise a foam reinforced by a filamentary matrix, or may comprise a foam with an additional layer of hydrogel that expands in the presence of bodily fluids to provide further compression on the tissue. According to the invention, the tissue thickness compensator may also consist of a material and/or a coating on the second or third layer which expands in the presence of bodily fluids to provide further compression on the tissue. Such a layer may be a hydrogel, which may be of synthetic and/or natural origin material, and may, for example, be biodurable and/or biodegradable. The tissue thickness compensator may comprise microgels or nanogels. Hydrogels may include microgels and/or nanogels derived from carbohydrates. The tissue thickness compensator may be reinforced with fibrous nonwoven or fibrous mesh type elements that provide additional flexibility, stiffness, and/or strength. According to the invention, the tissue thickness compensator has a porous morphology exhibiting a gradient structure, eg small pores on one surface and larger pores on the other surface. Such morphology is more ideal for tissue growth or hemostatic behavior. Furthermore, gradients can also be combined with varying bioabsorption profiles. A short-term absorption profile may be preferred to address hemostasis, while a long-term absorption profile may address better tissue healing without leakage.
非合成材料的示例包括但不限于冻干多糖、糖蛋白、牛心包膜、胶原、明胶、血纤维蛋白、纤维蛋白原、弹性蛋白、蛋白聚糖、角蛋白、白蛋白、羟乙基纤维素、纤维素、氧化纤维素、氧化再生纤维素(ORC)、羟丙基纤维素、羧乙基纤维素、羧甲基纤维素、甲壳质、脱乙酰壳多糖、酪蛋白、藻酸盐以及它们的组合。Examples of non-synthetic materials include, but are not limited to, lyophilized polysaccharides, glycoproteins, bovine pericardium, collagen, gelatin, fibrin, fibrinogen, elastin, proteoglycans, keratin, albumin, hydroxyethyl cellulose cellulose, oxidized cellulose, oxidized regenerated cellulose (ORC), hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, chitin, chitosan, casein, alginate and their combination.
合成可吸收材料的示例包括但不限于聚(乳酸)(PLA)、聚(L-乳酸)(PLLA)、聚已内酯(PCL)、聚乙醇酸(PGA)、聚(三亚甲基碳酸酯)(TMC)、聚对苯二甲酸乙二醇酯(PET)、聚羟基链烷酸酯(PHA)、乙交酯和ε-己内酯(PGCL)的共聚物、乙交酯和三亚甲基碳酸酯的共聚物、聚(癸二酸甘油酯)(PGS)、聚(二氧杂环己酮)(PDS)、聚酯、聚(原酸酯)、聚含氧酸酯、聚醚酯、聚碳酸酯、聚酰胺酯、聚酸酐、多糖、聚(酯-酰胺)、酪氨酸基聚芳酯、聚胺、酪氨酸基聚亚氨碳酸酯、酪氨酸基聚碳酸酯、聚(D,L-丙交酯-氨基甲酸酯)、聚(羟基丁酸酯)、聚(B-羟基丁酸酯)、聚(E-己内酯)、聚乙二醇(PEG)、聚[二(羧基苯氧基)磷腈]、聚(氨基酸)、拟聚(氨基酸)、可吸收聚氨酯、聚(膦嗪)、聚磷腈、聚氧化烯、聚丙烯酰胺、聚甲基丙烯酸羟乙酯、聚乙烯吡咯烷酮、聚乙烯醇、聚(己内酯)、聚丙烯酸、聚乙酸酯、聚丙烯、脂族聚酯、甘油、共聚(醚-酯)、聚草酸亚烷基二醇酯、聚酰胺、聚(亚氨基碳酸酯)、聚草酸亚烷基二醇酯以及它们的组合。聚酯可选自聚丙交酯、聚乙交酯、三亚甲基碳酸酯、聚二氧杂环己酮、聚己内酯、聚丁烯酯、以及它们的组合。Examples of synthetic absorbable materials include, but are not limited to, poly(lactic acid) (PLA), poly(L-lactic acid) (PLLA), polycaprolactone (PCL), polyglycolic acid (PGA), poly(trimethylene carbonate ) (TMC), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), copolymers of glycolide and ε-caprolactone (PGCL), glycolide and trimethylene Copolymers of carbonates, poly(glyceryl sebacate) (PGS), poly(dioxanone) (PDS), polyesters, poly(orthoesters), polyoxoesters, polyethers Esters, polycarbonates, polyesteramides, polyanhydrides, polysaccharides, poly(ester-amides), tyrosine-based polyarylates, polyamines, tyrosine-based polyimidocarbonates, tyrosine-based polycarbonates , poly(D,L-lactide-urethane), poly(hydroxybutyrate), poly(B-hydroxybutyrate), poly(E-caprolactone), polyethylene glycol (PEG ), poly[bis(carboxyphenoxy)phosphazene], poly(amino acid), pseudopoly(amino acid), absorbable polyurethane, poly(phosphazine), polyphosphazene, polyoxyalkylene, polyacrylamide, polyformazine hydroxyethyl acrylate, polyvinylpyrrolidone, polyvinyl alcohol, poly(caprolactone), polyacrylic acid, polyacetate, polypropylene, aliphatic polyester, glycerin, copoly(ether-ester), polyalkylene oxalate glycol esters, polyamides, poly(iminocarbonates), polyalkylene oxalates, and combinations thereof. The polyester may be selected from polylactide, polyglycolide, trimethylene carbonate, polydioxanone, polycaprolactone, polybutenyl ester, and combinations thereof.
合成的可吸收聚合物可包括例如可以商标名称VICRYL(polyglactic 910)从Ethicon,Inc.商购获得的90/10聚(乙交酯-L-丙交酯)共聚物、可以商标名称DEXON从American Cyanamid Co.商购获得的聚乙交酯、可以商标名称PDS从Ethicon,Inc.商购获得的聚二氧杂环己酮、可以商标名称MAXON从American Cyanamid Co.商购获得的聚(乙交酯-三亚甲基碳酸酯)无规嵌段共聚物、可以商标名称MONOCRYL从Ethicon公司商购获得的75/25聚(乙交酯-ε-己内酯-poliglecaprolactone 25)共聚物中的一种或多种。Synthetic absorbable polymers can include, for example, 90/10 poly(glycolide-L-lactide) copolymer commercially available under the trade name VICRYL (polyglactic 910) from Ethicon, Inc., available under the trade name DEXON from American Polyglycolide commercially available from Cyanamid Co., polydioxanone commercially available under the trade name PDS from Ethicon, Inc., poly(glycolide) commercially available under the trade name MAXON from American Cyanamid Co. Ester-trimethylene carbonate) random block copolymer, one of the 75/25 poly(glycolide-ε-caprolactone-poliglecaprolactone 25) copolymers commercially available from Ethicon Corporation under the trade name MONOCRYL or more.
合成的非可吸收材料包括但不限于聚氨酯、聚丙烯(PP)、聚乙烯(PE)、聚碳酸酯、聚酰胺,z诸如尼龙、聚氯乙烯(PVC)、聚甲基丙烯酸甲酯(PMMA)、聚苯乙烯(PS)、聚酯、聚醚醚酮(PEEK)、聚四氟乙烯(PTFE)、聚三氟氯乙烯(PTFCE)、聚氟乙烯(PVF)、氟化乙烯丙烯(FEP)、聚缩醛、聚砜、硅、以及它们的组合。合成的非可吸收聚合物可包括但不限于泡沫弹性体和多孔弹性体,例如硅氧烷、聚异戊二烯和橡胶。合成聚合物可包括膨胀的聚四氟乙烯(ePTFE),可以商标名称GORE-TEX软组织片从W.L.Gore&Associates,Inc.商购获得;以及共聚醚酯聚氨酯泡沫,其以商品名称NASOPORE从Polyganics商购获得。Synthetic nonabsorbable materials include, but are not limited to, polyurethane, polypropylene (PP), polyethylene (PE), polycarbonate, polyamides, such as nylon, polyvinyl chloride (PVC), polymethylmethacrylate (PMMA) ), polystyrene (PS), polyester, polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE), polytrifluorochloroethylene (PTFCE), polyvinyl fluoride (PVF), fluorinated ethylene propylene (FEP ), polyacetal, polysulfone, silicon, and combinations thereof. Synthetic non-absorbable polymers may include, but are not limited to, foamed and cellular elastomers such as silicones, polyisoprenes, and rubbers. Synthetic polymers can include expanded polytetrafluoroethylene (ePTFE), commercially available under the tradename GORE-TEX Soft Tissue Sheets from W.L. Gore & Associates, Inc.; and copolyetherester polyurethane foam, commercially available under the tradename NASOPORE from Polyganics .
聚合物组合物可包括例如按重量计大约50%到大约90%的PLLA的聚合物组合物,以及按重量计大约50%到大约10%的PCL的聚合物组合物。聚合物组合物可包括例如按重量计大约70%的PLLA,以及按重量计大约30%的PCL。聚合物组合物可包括例如按重量计大约55%到大约85%的PGA的聚合物组合物,以及按重量计15%到45%的PCL的聚合物组合物。聚合物组合物可包括例如按重量计大约65%的PGA,以及按重量计大约35%的PCL。聚合物组合物可包括例如按重量计大约90%到大约95%的PGA的聚合物组合物,以及按重量计大约5%到大约10%的PLA的聚合物组合物。The polymer composition may include, for example, a polymer composition of about 50% to about 90% by weight of PLLA, and a polymer composition of about 50% to about 10% by weight of PCL. The polymer composition may include, for example, about 70% by weight of PLLA, and about 30% by weight of PCL. The polymer composition may include, for example, a polymer composition of about 55% to about 85% by weight of PGA, and a polymer composition of 15% to 45% by weight of PCL. The polymer composition may include, for example, about 65% by weight of PGA, and about 35% by weight of PCL. The polymer composition may include, for example, a polymer composition of about 90% to about 95% by weight of PGA, and a polymer composition of about 5% to about 10% by weight of PLA.
合成的可吸收聚合物可包括可生物吸收的、生物相容性弹性体共聚物。合适的生物可吸收的、生物相容的弹性体共聚物包括但不限于ε-己内酯和乙交酯的共聚物(ε-己内酯与乙交酯的摩尔比优选地为约30:70至约70:30,优选地为35:65至约65:35,并且更优选地为45:55至35:65);ε-己内酯和丙交酯(包括L-丙交酯、D-丙交酯、它们的共混物或乳酸共聚物)的弹性体共聚物(ε-己内酯与丙交酯的摩尔比优选地为约35:65至约65:35,并且更优选地为45:55至30:70);对二氧杂环己酮(1,4-二氧杂环己烷-2-酮)和丙交酯(包括L-丙交酯、D-丙交酯和乳酸)的弹性体共聚物(对二氧杂环己酮与丙交酯的摩尔比优选地为约40:60至约60:40);ε-己内酯和对二氧杂环己酮的弹性体共聚物(ε-己内酯与对二氧杂环己酮的摩尔比优选地为约30:70至约70:30);对二氧杂环己酮和三亚甲基碳酸酯的弹性体共聚物(对二氧杂环己酮与三亚甲基碳酸酯的摩尔比优选为约30:70至约70:30);三亚甲基碳酸酯和乙交酯的弹性体共聚物(三亚甲基碳酸酯与乙交酯的摩尔比优选为约30:70至约70:30);三亚甲基碳酸酯和丙交酯(包括L-丙交酯、D-丙交酯、它们的共混物或乳酸共聚物)的弹性体共聚物(三亚甲基碳酸酯与丙交酯的摩尔比优选为约30:70至约70:30);以及它们的共混物。弹性体共聚物可为乙交酯和ε-己内酯的共聚物。作为另外一种选择,弹性体共聚物为丙交酯和ε-己内酯的共聚物。Synthetic absorbable polymers may include bioabsorbable, biocompatible elastomeric copolymers. Suitable bioabsorbable, biocompatible elastomeric copolymers include, but are not limited to, copolymers of ε-caprolactone and glycolide (the molar ratio of ε-caprolactone to glycolide is preferably about 30: 70 to about 70:30, preferably 35:65 to about 65:35, and more preferably 45:55 to 35:65); ε-caprolactone and lactide (including L-lactide, Elastomeric copolymers of D-lactide, their blends, or lactic acid copolymers) (the molar ratio of ε-caprolactone to lactide is preferably from about 35:65 to about 65:35, and more preferably 45:55 to 30:70); for dioxanone (1,4-dioxan-2-one) and lactide (including L-lactide, D-lactide ester and lactic acid) (the molar ratio of p-dioxanone to lactide is preferably from about 40:60 to about 60:40); ε-caprolactone and p-dioxanone Elastomeric copolymers of ketones (the molar ratio of ε-caprolactone to p-dioxanone is preferably from about 30:70 to about 70:30); p-dioxanone and trimethylene carbonate (The molar ratio of dioxanone to trimethylene carbonate is preferably from about 30:70 to about 70:30); Elastomeric copolymers of trimethylene carbonate and glycolide ( The molar ratio of trimethylene carbonate to glycolide is preferably from about 30:70 to about 70:30); trimethylene carbonate and lactide (including L-lactide, D-lactide, their blends or lactic acid copolymers) (the molar ratio of trimethylene carbonate to lactide is preferably from about 30:70 to about 70:30); and blends thereof. The elastomeric copolymer may be a copolymer of glycolide and ε-caprolactone. Alternatively, the elastomeric copolymer is a copolymer of lactide and ε-caprolactone.
公布于1995年11月21日的名称为“ELASTOMERIC MEDICAL DEVICE”的美国专利5,468,253以及公布于2001年12月4日的名称为“FOAM BUTTRESS FOR STAPLING APPARATUS”的美国专利6,325,810的公开内容据此各自全文以引用方式并入本文。The disclosures of U.S. Patent 5,468,253, issued November 21, 1995, entitled "ELASTOMERIC MEDICAL DEVICE," and U.S. Patent 6,325,810, issued December 4, 2001, entitled "FOAM BUTTRESS FOR STAPLING APPARATUS," are hereby incorporated by reference in their entirety Incorporated herein by reference.
组织厚度补偿件可包含乳化剂。乳化剂的示例可包括但不限于水溶性聚合物,诸如聚乙烯醇(PVA)、乙烯吡咯烷酮(PVP)、聚乙二醇(PEG)、聚丙二醇(PPG)、普流罗尼(PLURONICS)、吐温(TWEENS)、多糖以及它们的组合。The tissue thickness compensator may contain an emulsifier. Examples of emulsifiers may include, but are not limited to, water-soluble polymers such as polyvinyl alcohol (PVA), vinylpyrrolidone (PVP), polyethylene glycol (PEG), polypropylene glycol (PPG), PLURONICS, TWEENS, polysaccharides and combinations thereof.
组织厚度补偿件可包含表面活性剂。The tissue thickness compensator may contain a surfactant.
表面活性剂的示例可包括但不限于聚丙烯酸、甲基化酶、甲基纤维素、乙基纤维素、丙基纤维素、羟基乙基纤维素、羧基甲基纤维素、聚氧乙烯十六烷基醚、聚氧乙烯月桂基醚、聚氧乙烯辛基醚、聚氧乙烯辛基苯基醚、聚氧乙烯油基醚、聚氧乙烯脱水山梨糖醇单月桂酸酯、聚氧乙烯硬脂基醚、聚氧乙烯壬基苯基醚、二烷基苯氧基聚(乙烯氧基)乙醇、和泊洛沙姆。Examples of surfactants may include, but are not limited to, polyacrylic acid, methylase, methylcellulose, ethylcellulose, propylcellulose, hydroxyethylcellulose, carboxymethylcellulose, polyoxyethylene cetyl Alkyl ether, polyoxyethylene lauryl ether, polyoxyethylene octyl ether, polyoxyethylene octylphenyl ether, polyoxyethylene oleyl ether, polyoxyethylene sorbitan monolaurate, polyoxyethylene hard Fatty ethers, polyoxyethylene nonylphenyl ethers, dialkylphenoxypoly(ethyleneoxy)ethanols, and poloxamers.
聚合物组合物可包括药物活性剂。聚合物组合物可释放治疗有效量的药物活性剂。当聚合物组合物被解吸/吸收时药物活性剂可被释放。药物活性剂可被释放到流体诸如流经聚合物组合物之上或穿过聚合物组合物的血液中。药物活性剂的示例可包括但不限于止血剂和药物,诸如血纤维蛋白、凝血酶和氧化再生纤维素(ORC);抗炎药物,诸如双氯芬酸、阿司匹林、萘普生、舒林酸和氢化可的松;抗生素和抗微生物药物或制剂,诸如三氯生、离子银、氨苄青霉素、庆大霉素、多粘菌素B、氯霉素;以及抗癌剂,诸如顺铂、丝裂霉素、阿霉素。The polymer composition may include a pharmaceutically active agent. The polymer composition releases a therapeutically effective amount of a pharmaceutically active agent. The pharmaceutically active agent can be released when the polymer composition is desorbed/absorbed. The pharmaceutically active agent can be released into a fluid such as blood flowing over or through the polymer composition. Examples of pharmaceutically active agents may include, but are not limited to, hemostatic agents and drugs such as fibrin, thrombin, and oxidized regenerated cellulose (ORC); anti-inflammatory drugs such as diclofenac, aspirin, naproxen, sulindac, and hydrocortisone; antibiotics and antimicrobial drugs or agents such as triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, chloramphenicol; and anticancer agents such as cisplatin, mitomycin ,Adriamycin.
聚合物组合物可包括止血材料。组织厚度补偿件可包含止血材料,其包括聚(乳酸)、聚(乙醇酸)、聚(羟基丁酸酯)、聚(己内酯)、聚(二氧杂环己酮)、聚氧化烯、共聚(醚-酯)、胶原、明胶、凝血酶、血纤维蛋白、纤维蛋白原、纤粘蛋白、弹性蛋白、白蛋白、血红蛋白、卵清蛋白、多糖、透明质酸、硫酸软骨素、羟乙基淀粉、羟乙基纤维素、纤维素、氧化纤维素、羟丙基纤维素、羧乙基纤维素、羧甲基纤维素、甲壳质、脱乙酰壳多糖、琼脂糖、麦芽糖、麦芽糖糊精、海藻酸盐、凝血因子、甲基丙烯酸盐、聚氨酯、丙烯酸酯、血小板激动剂、血管收缩剂、矾、钙、RGD肽、蛋白质、鱼精蛋白硫酸盐、ε-氨基己酸、硫酸铁、碱式硫酸铁、氯化铁、锌、氯化锌、氯化铝、硫酸铝、醋酸铝、高锰酸盐、单宁酸、骨蜡、聚乙二醇、岩藻聚糖以及它们的组合。组织厚度补偿件的特征可在于止血特性。The polymer composition may include a hemostatic material. The tissue thickness compensator may comprise hemostatic materials including poly(lactic acid), poly(glycolic acid), poly(hydroxybutyrate), poly(caprolactone), poly(dioxanone), polyoxyalkylene , copoly(ether-ester), collagen, gelatin, thrombin, fibrin, fibrinogen, fibronectin, elastin, albumin, hemoglobin, ovalbumin, polysaccharide, hyaluronic acid, chondroitin sulfate, hydroxyl Ethyl starch, hydroxyethyl cellulose, cellulose, oxidized cellulose, hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, chitin, chitosan, agarose, maltose, maltose paste Alginate, alginate, coagulation factor, methacrylate, polyurethane, acrylate, platelet agonist, vasoconstrictor, alum, calcium, RGD peptide, protein, protamine sulfate, ε-aminocaproic acid, iron sulfate , basic ferric sulfate, ferric chloride, zinc, zinc chloride, aluminum chloride, aluminum sulfate, aluminum acetate, permanganate, tannic acid, bone wax, polyethylene glycol, fucoidan and their combination. The tissue thickness compensator may be characterized by hemostatic properties.
组织厚度补偿件的聚合物组合物的特征在于例如百分孔隙率、孔尺寸、和/或硬度。聚合物组合物可具有例如按体积计大约30%到大约99%的百分孔隙率。聚合物组合物可具有例如按体积计大约60%到大约98%的百分孔隙率。聚合物组合物可具有例如按体积计大约85%到大约97%的百分孔隙率。聚合物组合物可包括例如按重量计大约70%的PLLA和按重量计大约30%的PCL,并且可包括例如按体积计大约90%的孔隙率。例如,因此聚合物组合物将包括按体积计大约10%的共聚物。聚合物组合物可包括例如按重量计大约65%的PGA和按重量计大约35%的PCL,并且可具有例如按体积计大约93%到按体积计大约95%的百分孔隙率。聚合物组合物可包括按体积计大于85%的孔隙率。聚合物组合物可具有例如大约5微米到大约2000微米的孔尺寸。聚合物组合物可具有例如介于大约10微米到大约100微米之间的孔尺寸。例如,聚合物组合物可例如包括PGA和PCL的共聚物。聚合物组合物可具有例如介于大约100微米到大约1000微米之间的孔尺寸。例如,聚合物组合物可例如包括PLLA和PCL的共聚物。The polymer composition of the tissue thickness compensator is characterized, for example, by percent porosity, pore size, and/or hardness. The polymer composition can have a percent porosity of, for example, from about 30% to about 99% by volume. The polymer composition can have a percent porosity of, for example, from about 60% to about 98% by volume. The polymer composition can have a percent porosity of, for example, from about 85% to about 97% by volume. The polymer composition may include, for example, about 70% by weight of PLLA and about 30% by weight of PCL, and may include, for example, about 90% by volume of porosity. For example, the polymer composition would thus comprise approximately 10% by volume of copolymer. The polymer composition may include, for example, about 65% by weight of PGA and about 35% by weight of PCL, and may have a percent porosity, for example, of about 93% by volume to about 95% by volume. The polymer composition may include a porosity greater than 85% by volume. The polymer composition can have a pore size, for example, from about 5 microns to about 2000 microns. The polymer composition can have, for example, a pore size between about 10 microns and about 100 microns. For example, the polymer composition may, for example, include a copolymer of PGA and PCL. The polymer composition can have, for example, a pore size between about 100 microns and about 1000 microns. For example, the polymer composition may eg comprise a copolymer of PLLA and PCL.
根据某些方面,聚合物组合物的硬度可以肖氏硬度表示,该肖氏硬度可被定义为诸如由肖氏硬度计所测定的对材料的永久凹痕的耐受性。为了评估给定材料的硬度计值,根据名称为“Standard Test Method for Rubber Property-Durometer Hardness”的ASTM程序D2240-00,用硬度计压头脚将压力施加至材料,其全文以引用的方式并入本文。可将硬度计压头脚施用到材料并持续足够的一段时间,诸如15秒,例如,其中读数从合适的标度读取。根据所用的标度类型,当压头脚完全穿透材料时,可获得读数0,并且当材料未被穿透时,可获得读数100。该读数无量纲。可例如根据ASTMD2240-00根据任何合适的标度诸如A类和/或OO类标度来决定硬度计。组织厚度补偿件的聚合物组合物可具有大约4A到大约16A的肖氏A硬度值,该肖氏A硬度值例如在大约45OO到大约65OO的肖氏OO范围。例如,聚合物组合物可包括例如PLLA/PCL共聚物或PGA/PCL共聚物。组织厚度补偿件的聚合物组合物可具有小于15A的肖氏A硬度值。组织厚度补偿件的聚合物组合物可具有小于10A的肖氏A硬度值。组织厚度补偿件的聚合物组合物可具有小于5A的肖氏A硬度值。聚合物材料可具有例如大约35OO到大约75OO的肖氏OO组合物值。According to certain aspects, the hardness of the polymer composition may be expressed in Shore hardness, which may be defined as the resistance to permanent dent of a material such as measured by a Shore durometer. To evaluate the durometer value for a given material, pressure is applied to the material with a durometer foot in accordance with ASTM procedure D2240-00 entitled "Standard Test Method for Rubber Property—Durometer Hardness," the entirety of which is incorporated by reference herein. into this article. The durometer foot may be applied to the material for a sufficient period of time, such as 15 seconds, for example, where the reading is taken from an appropriate scale. Depending on the type of scale used, a reading of 0 is obtained when the indenter foot has completely penetrated the material, and a reading of 100 is obtained when the material has not been penetrated. This reading is dimensionless. Durometers may be determined according to any suitable scale, such as the Type A and/or Type 00 scales, eg, according to ASTM D2240-00. The polymer composition of the tissue thickness compensator may have a Shore A hardness value of about 4A to about 16A, for example in the Shore OO range of about 45OO to about 65OO. For example, the polymer composition may include, for example, a PLLA/PCL copolymer or a PGA/PCL copolymer. The polymer composition of the tissue thickness compensator may have a Shore A hardness value of less than 15A. The polymer composition of the tissue thickness compensator may have a Shore A hardness value of less than 10A. The polymer composition of the tissue thickness compensator may have a Shore A hardness value of less than 5A. The polymeric material may have a Shore OO composition value of, for example, from about 3500 to about 7500.
聚合物组合物可具有上述识别出的特性中的至少两种。聚合物组合物可具有上述识别出的特性中的至少三种。聚合物组合物可具有例如按体积计85%到97%的孔隙率、5微米到2000微米的孔尺寸、和4A到16A的肖氏A硬度值以及45OO到65OO的肖氏OO硬度值。聚合物组合物可包括70重量%的PLLA的聚合物组合物以及30重量%的PCL的聚合物组合物;所述聚合物组合物具有例如按体积计90%的孔隙率、100微米到1000微米的孔尺寸和4A到16A的肖氏A硬度值以及45OO到65OO的肖氏OO硬度值。聚合物组合物可包括65重量%的PGA的聚合物组合物以及35重量%的PCL的聚合物组合物;所述聚合物组合物具有例如按体积计从93%到95%的孔隙率、10微米到100微米的孔尺寸和4A到16A的肖氏A硬度值以及45OO到65OO的肖氏OO硬度值。A polymer composition may have at least two of the above-identified properties. A polymer composition may have at least three of the above-identified properties. The polymer composition may have, for example, a porosity by volume of 85% to 97%, a pore size of 5 microns to 2000 microns, and a Shore A hardness value of 4A to 16A and a Shore OO hardness value of 4500 to 6500. The polymer composition may comprise a polymer composition of 70% by weight of PLLA and a polymer composition of 30% by weight of PCL; The hole size and the Shore A hardness value of 4A to 16A and the Shore OO hardness value of 45OO to 65OO. The polymer composition may comprise a polymer composition of 65% by weight of PGA and a polymer composition of 35% by weight of PCL; Micron to 100 micron pore sizes and Shore A hardness values from 4A to 16A and Shore OO hardness values from 45OO to 65OO.
组织厚度补偿件可包括膨胀的材料。如上所述,组织厚度补偿件可包含在未压缩或部署时膨胀的压缩材料。组织厚度补偿件可包括原位形成的自膨胀材料。组织厚度补偿件可包括至少一个前体,该前体可被选择以在与其他一个或多个前体、水和/或体液中的至少一者接触时自发地交联参见图205,第一前体可接触一个或多个其他前体以形成可膨胀的和/或溶胀性的组织厚度补偿件。组织厚度补偿件可包括例如流体溶胀性的组合物,诸如水溶胀性的组合物。组织厚度补偿件可包括包含水的凝胶。The tissue thickness compensator may include an expanded material. As noted above, the tissue thickness compensator may comprise a compressed material that expands when uncompressed or when deployed. The tissue thickness compensator may include a self-expanding material formed in situ. The tissue thickness compensator can comprise at least one precursor which can be selected to spontaneously cross-link upon contact with at least one of the other precursor(s), water and/or bodily fluids. See FIG. 205, first The precursor may be contacted with one or more other precursors to form an expandable and/or swellable tissue thickness compensator. The tissue thickness compensator may comprise, for example, a fluid-swellable composition, such as a water-swellable composition. The tissue thickness compensator may comprise a gel comprising water.
参见图189A和图189B,例如,组织厚度补偿件70000可包括至少一个水凝胶前体70010,该水凝胶前体70010被选择以在原位和/或体内形成水凝胶,从而使组织厚度补偿件70000膨胀。图189A示出了包括封装件的组织厚度补偿件70000,该封装件在膨胀之前包括第一水凝胶前体70010A和第二水凝胶前体70010B。如图189A所示,第一水凝胶前体70010A和第二水凝胶前体70010B在相同的封装件中可物理地彼此分隔开。第一封装件可包括第一水凝胶前体70010A,并且第二封装件可包括第二水凝胶前体70010B。图189B示出了当水凝胶在原位和/或体内形成时厚度组织补偿件70000的膨胀。如图189B所示,封装件可破裂,并且第一水凝胶前体70010A可接触第二水凝胶前体70010B以形成水凝胶70020。水凝胶可包括可膨胀的材料。例如,水凝胶可膨胀长达72小时。189A and 189B, for example, a tissue thickness compensator 70000 can include at least one hydrogel precursor 70010 selected to form a hydrogel in situ and/or in vivo such that tissue The thickness compensator 70000 expands. Figure 189A shows a tissue thickness compensator 70000 comprising an encapsulation comprising a first hydrogel precursor 70010A and a second hydrogel precursor 70010B prior to expansion. As shown in Figure 189A, the first hydrogel precursor 70010A and the second hydrogel precursor 70010B can be physically separated from each other within the same package. The first package can include a first hydrogel precursor 70010A, and the second package can include a second hydrogel precursor 70010B. Figure 189B illustrates expansion of the thickness tissue compensator 70000 as the hydrogel forms in situ and/or in vivo. As shown in FIG. 189B , the encapsulation can be ruptured, and the first hydrogel precursor 70010A can contact the second hydrogel precursor 70010B to form a hydrogel 70020 . Hydrogels can include swellable materials. For example, hydrogels can swell for up to 72 hours.
组织厚度补偿件可包括可生物降解的泡沫,该可生物降解的泡沫具有包含嵌入其中的干燥水凝胶颗粒或颗粒剂的封装件。不希望受限于任何特定理论,泡沫中的封装件可通过接触水凝胶前体的水性溶液和生物相容性材料的有机溶液而形成,从而形成泡沫。如图206所示,水性溶液和有机溶液可形成胶束。水性溶液和有机溶液可被干燥以封装泡沫内的干燥水凝胶颗粒或颗粒剂。例如,水凝胶前体(诸如亲水性聚合物)可溶解于水以形成胶束的分散体。水性溶液可接触包含聚(乙醇酸)和聚己内酯的二氧杂环己烷的有机溶液。水性溶液和有机溶液可被冻干从而形成具有分散其中的干燥水凝胶颗粒或颗粒剂的生物可降解的泡沫。不希望受限于任何特定理论,据信,胶束形成具有分散在泡沫结构内的干燥水凝胶颗粒或颗粒剂的封装件。该封装件可破裂,并且干燥水凝胶颗粒或颗粒剂可接触流体(诸如体液)并膨胀。The tissue thickness compensator may comprise a biodegradable foam having an enclosure containing dry hydrogel particles or granules embedded therein. Without wishing to be bound by any particular theory, the encapsulation in the foam may be formed by contacting an aqueous solution of the hydrogel precursor and an organic solution of the biocompatible material, thereby forming the foam. As shown in Figure 206, aqueous and organic solutions can form micelles. Aqueous and organic solutions can be dried to encapsulate dried hydrogel particles or granules within the foam. For example, hydrogel precursors such as hydrophilic polymers can be dissolved in water to form a dispersion of micelles. The aqueous solution may be contacted with an organic solution of dioxane comprising poly(glycolic acid) and polycaprolactone. Aqueous and organic solutions can be lyophilized to form biodegradable foams having dried hydrogel particles or granules dispersed therein. Without wishing to be bound by any particular theory, it is believed that the micelles form encapsulates with dry hydrogel particles or granules dispersed within the foam structure. The package can be ruptured and the dry hydrogel particle or granules can come into contact with a fluid (such as bodily fluid) and swell.
例如,组织厚度补偿件在接触活化剂(诸如流体)时可膨胀。参见图190,例如,组织厚度补偿件70050可包括溶胀性材料,诸如水凝胶,所述溶胀性材料例如在接触流体70055(诸如体液、盐水溶液、水和/或活化剂)时膨胀。体液的示例可包括但不限于血液、血浆、腹膜液、脑脊髓液、尿液、淋巴液、滑液、玻璃体液、唾液、胃肠腔内容物、胆汁、和/或气体(例如CO2)。组织厚度补偿件70050在组织厚度补偿件70050吸收流体时可膨胀。又如,组织厚度补偿件70050可包括非交联水凝胶,该非交联水凝胶在接触包括交联剂的活化剂70055时膨胀以形成交联水凝胶。组织厚度补偿件在接触活化剂时可膨胀。组织厚度补偿件可从接触开始膨胀或溶胀长达72小时,诸如从24小时到72小时,长达24小时、长达48小时以及长达72小时,从而例如为组织提供连续增大的压力和/或压缩。如图190所示,在流体70055接触组织厚度补偿件70050之后,组织厚度补偿件70050的初始厚度可小于膨胀厚度。For example, a tissue thickness compensator can expand when exposed to an active agent, such as a fluid. Referring to Fig. 190, for example, a tissue thickness compensator 70050 can comprise a swellable material, such as a hydrogel, that swells, for example, upon contact with a fluid 70055, such as bodily fluids, saline solution, water, and/or an active agent. Examples of bodily fluids may include, but are not limited to, blood, plasma, peritoneal fluid, cerebrospinal fluid, urine, lymph, synovial fluid, vitreous humor, saliva, gastrointestinal luminal contents, bile, and/or gases (eg,CO2 ) . The tissue thickness compensator 70050 is expandable when the tissue thickness compensator 70050 absorbs fluid. As another example, the tissue thickness compensator 70050 can comprise a non-crosslinked hydrogel that swells to form a crosslinked hydrogel when contacted with an activating agent 70055 comprising a crosslinking agent. The tissue thickness compensator is expandable when exposed to an activating agent. The tissue thickness compensator may expand or swell for up to 72 hours from contact, such as from 24 hours to 72 hours, up to 24 hours, up to 48 hours, and up to 72 hours, for example, to provide continuously increasing pressure and pressure to the tissue. /or compression. As shown in FIG. 190, after the fluid 70055 contacts the tissue thickness compensator 70050, the initial thickness of the tissue thickness compensator 70050 can be less than the expanded thickness.
参见图187和图188a,钉仓70100可包括组织厚度补偿件70105和各自包括钉腿70112的多个钉70110。如图187所示,组织厚度补偿件70105可具有小于钉70110的击发高度的初始厚度或压缩高度。组织厚度补偿件70100能够在与流体70102(诸如体液、盐水溶液和/或活化剂)接触时原位和/或在体内膨胀,从而例如抵靠钉70110的腿70112推动组织T。如图188所示,组织厚度补偿件70100可在接触流体70102时膨胀和/或溶胀。组织厚度补偿件70105可补偿在每个钉70110内捕获的组织T的厚度。如图188所示,组织厚度补偿件70105可具有小于钉70110的击发高度的膨胀厚度或未压缩高度。Referring to FIGS. 187 and 188a , a staple cartridge 70100 can include a tissue thickness compensator 70105 and a plurality of staples 70110 each including a staple leg 70112 . As shown in FIG. 187 , the tissue thickness compensator 70105 can have an initial thickness or compressed height that is less than the fired height of the staples 70110 . Tissue thickness compensator 70100 is capable of expanding in situ and/or in vivo upon contact with fluid 70102 , such as bodily fluids, saline solution, and/or activating agents, thereby pushing tissue T against legs 70112 of staples 70110 , for example. As shown in FIG. 188 , tissue thickness compensator 70100 can expand and/or swell upon contact with fluid 70102 . Tissue thickness compensator 70105 can compensate for the thickness of tissue T captured within each staple 70110. As shown in FIG. 188 , the tissue thickness compensator 70105 can have an expanded thickness or uncompressed height that is less than the fired height of the staples 70110 .
任选地,如上所述,组织厚度补偿件可包括初始厚度和膨胀厚度。组织厚度补偿件的初始厚度可为例如,其膨胀厚度的大约0.001%、其膨胀厚度的大约0.01%、其膨胀厚度的大约0.1%、其膨胀厚度的大约1%、其膨胀厚度的大约10%、其膨胀厚度的大约20%、其膨胀厚度的大约30%、其膨胀厚度的大约40%、其膨胀厚度的大约50%、其膨胀厚度的大约60%、其膨胀厚度的大约70%、其膨胀厚度的大约80%、和/或其膨胀厚度的大约90%。组织厚度补偿件的膨胀厚度可比其初始厚度厚例如约2倍、约5倍、约10倍、约50倍、约100倍、约200倍、约300倍、约400倍、约500倍、约600倍、约700倍、约800倍、约900倍和/或约1000倍。组织厚度补偿件的初始厚度可高达其膨胀厚度的1%、高达其膨胀厚度的5%、高达其膨胀厚度的10%和高达其膨胀厚度的50%。组织厚度补偿件的膨胀厚度可比其初始厚度厚至少50%、比其初始厚度厚至少100%、比其初始厚度厚至少300%以及比其初始厚度厚至少500%。如上所述,在各种情况下,作为以上所述的结果,组织厚度补偿件能够消除钉截留区域内的任何间隙。Optionally, as described above, the tissue thickness compensator may include an initial thickness and an expanded thickness. The initial thickness of the tissue thickness compensator can be, for example, about 0.001% of its expanded thickness, about 0.01% of its expanded thickness, about 0.1% of its expanded thickness, about 1% of its expanded thickness, about 10% of its expanded thickness , about 20% of its expanded thickness, about 30% of its expanded thickness, about 40% of its expanded thickness, about 50% of its expanded thickness, about 60% of its expanded thickness, about 70% of its expanded thickness, its about 80% of its expanded thickness, and/or about 90% of its expanded thickness. The expanded thickness of the tissue thickness compensator can be thicker than its original thickness, e.g., about 2 times, about 5 times, about 10 times, about 50 times, about 100 times, about 200 times, about 300 times, about 400 times, about 500 times, about 600 times, about 700 times, about 800 times, about 900 times and/or about 1000 times. The initial thickness of the tissue thickness compensator can be up to 1% of its expanded thickness, up to 5% of its expanded thickness, up to 10% of its expanded thickness, and up to 50% of its expanded thickness. The expanded thickness of the tissue thickness compensator may be at least 50% thicker, at least 100% thicker, at least 300% thicker, and at least 500% thicker than its original thickness. As noted above, in each case, the tissue thickness compensator is able to eliminate any gaps in the staple entrapment region as a result of the above.
如上所述,组织厚度补偿件可包括水凝胶。水凝胶可包括均聚物水凝胶、共聚物水凝胶、多元聚合物水凝胶、互穿聚合物水凝胶以及它们的组合。水凝胶可包括微凝胶、纳米凝胶以及它们的组合。水凝胶可大体包括能够吸收和/或保留流体的亲水性聚合物网络。水凝胶可包括非交联的水凝胶、交联的水凝胶以及它们的组合。水凝胶可包括化学交联剂、物理交联剂、疏水片段和/或水不溶解的片段。水凝胶可通过聚合反应、小分子交联和/或聚合物-聚合物交联来化学地交联。水凝胶可通过离子相互作用、疏水相互作用、氢键结合相互作用、立体络合和/或超分子化学来物理地交联。由于交联剂、疏水片段和/或水不溶解的片段,水凝胶可基本上为不溶解的,但由于吸收和/或保持流体,水凝胶可膨胀和/或溶胀。前体可与内源性材料和/或组织交联。As noted above, the tissue thickness compensator may comprise a hydrogel. Hydrogels may include homopolymer hydrogels, copolymer hydrogels, multipolymer hydrogels, interpenetrating polymer hydrogels, and combinations thereof. Hydrogels can include microgels, nanogels, and combinations thereof. Hydrogels can generally include a network of hydrophilic polymers capable of absorbing and/or retaining fluids. Hydrogels can include non-crosslinked hydrogels, crosslinked hydrogels, and combinations thereof. Hydrogels may include chemical cross-linkers, physical cross-linkers, hydrophobic segments and/or water-insoluble segments. Hydrogels can be chemically crosslinked by polymerization, small molecule crosslinking, and/or polymer-polymer crosslinking. Hydrogels can be physically crosslinked through ionic interactions, hydrophobic interactions, hydrogen bonding interactions, stereocomplexation, and/or supramolecular chemistry. The hydrogel may be substantially insoluble due to the cross-linking agent, hydrophobic segments, and/or water-insoluble segments, but may swell and/or swell as a result of absorbing and/or retaining fluid. Precursors can be cross-linked with endogenous materials and/or tissues.
水凝胶可包括环境敏感性水凝胶(ESH)。ESH可包括具有与环境条件相关的流体溶胀性特性的材料。环境条件可包括但不限于在手术部位的物理条件、生物条件和/或化学条件。例如,响应于温度、pH、电场、离子强度、酶和/或化学反应、电和/或磁刺激,以及其他生理的和环境的变量,水凝胶可溶胀或收缩。ESH可包括多官能的丙烯酸酯、甲基丙烯酸羟乙酯(HEMA)、弹性体丙烯酸酯和相关的单体。Hydrogels may include environmentally sensitive hydrogels (ESH). ESH can include materials that have fluid-swellability properties that are related to environmental conditions. Environmental conditions may include, but are not limited to, physical, biological, and/or chemical conditions at the surgical site. For example, hydrogels can swell or shrink in response to temperature, pH, electric fields, ionic strength, enzymatic and/or chemical reactions, electrical and/or magnetic stimuli, and other physiological and environmental variables. ESH can include multifunctional acrylates, hydroxyethyl methacrylate (HEMA), elastomeric acrylates, and related monomers.
包括水凝胶的组织厚度补偿件可包括上述非合成材料和合成材料中的至少一者。水凝胶可包括合成水凝胶和/或非合成水凝胶。组织厚度补偿件可包括多个层。多个层可包括多孔层和/或无孔层。例如,组织厚度补偿件可包括无孔层和多孔层。又如,组织厚度补偿件可包括第一无孔层和第二无孔层中间的多孔层。又如,组织厚度补偿件可包括第一多孔层和第二多孔层中间的无孔层。无孔层和多孔层可以相对于钉仓和/或砧座的表面按任何顺序定位。A tissue thickness compensator comprising a hydrogel may comprise at least one of the non-synthetic and synthetic materials described above. Hydrogels may include synthetic hydrogels and/or non-synthetic hydrogels. The tissue thickness compensator can include multiple layers. Multiple layers may include porous layers and/or non-porous layers. For example, a tissue thickness compensator can include a non-porous layer and a porous layer. As another example, the tissue thickness compensator can include a porous layer intermediate the first non-porous layer and the second non-porous layer. As another example, the tissue thickness compensator may include a non-porous layer intermediate the first porous layer and the second porous layer. The non-porous layer and the porous layer can be positioned in any order relative to the surface of the staple cartridge and/or anvil.
非合成材料的示例可包括但不限于白蛋白、藻酸盐、碳水化合物、酪蛋白、纤维素、甲壳质、脱乙酰壳多糖、胶原、血液、葡聚糖、弹性蛋白、血纤维蛋白、纤维蛋白原、明胶、肝素、透明质酸、角蛋白、蛋白质、血清和淀粉。纤维素可包括羟乙基纤维素、氧化纤维素、氧化再生纤维素(ORC)、羟丙基纤维素、羧乙基纤维素、羧甲基纤维素以及它们的组合。胶原可包括牛心包膜。碳水化合物可包括多糖,诸如冻干多糖。蛋白质可包括糖蛋白、蛋白聚糖以及它们的组合。Examples of non-synthetic materials may include, but are not limited to, albumin, alginate, carbohydrates, casein, cellulose, chitin, chitosan, collagen, blood, dextran, elastin, fibrin, fiber Proteinogen, gelatin, heparin, hyaluronic acid, keratin, protein, serum and starch. Cellulose may include hydroxyethyl cellulose, oxidized cellulose, oxidized regenerated cellulose (ORC), hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, and combinations thereof. Collagen may include bovine pericardium. Carbohydrates may include polysaccharides, such as lyophilized polysaccharides. Proteins can include glycoproteins, proteoglycans, and combinations thereof.
合成材料的示例可包括但不限于聚(乳酸)、聚(乙醇酸)、聚(羟基丁酸酯)、聚(膦嗪)、聚酯、聚乙二醇、聚环氧乙烷、聚环氧乙烷-聚环氧丙烷共聚物、共聚环氧乙烷、聚氧化烯、聚丙烯酰胺、聚甲基丙烯酸羟乙酯、聚(乙烯吡咯烷酮)、聚乙烯醇、聚(己内酯)、聚(二氧杂环己酮)、聚丙烯酸、聚乙酸酯、聚丙烯、脂族聚酯、甘油、聚(氨基酸)、共聚(醚-酯)、聚草酸亚烷基二醇酯、聚酰胺、聚(亚氨基碳酸酯)、聚含氧酸酯、聚原酸酯、聚磷腈以及它们的组合。可使用常规的方法合成地制备上述非合成材料,例如合成透明质酸。Examples of synthetic materials may include, but are not limited to, poly(lactic acid), poly(glycolic acid), poly(hydroxybutyrate), poly(phosphazine), polyester, polyethylene glycol, polyethylene oxide, polycyclic Ethylene oxide-polypropylene oxide copolymer, polyethylene oxide, polyoxyalkylene, polyacrylamide, polyhydroxyethyl methacrylate, poly(vinylpyrrolidone), polyvinyl alcohol, poly(caprolactone), Poly(dioxanone), polyacrylic acid, polyacetate, polypropylene, aliphatic polyester, glycerin, poly(amino acid), copoly(ether-ester), polyalkylene oxalate, poly Amides, poly(iminocarbonates), polyoxyesters, polyorthoesters, polyphosphazenes, and combinations thereof. The non-synthetic materials described above can be prepared synthetically using conventional methods, such as synthetic hyaluronic acid.
水凝胶可由一个或多个水凝胶前体制成。前体可包括单体和/或大分子单体。水凝胶前体可包括亲电体官能团和/或亲核体亲电体官能团。一般来讲,亲电体可与亲核体反应以形成化学键。本文中使用的术语“官能团”是指能够彼此反应以形成化学键的亲电基团或亲核基团。亲电官能团的示例可包括但不限于N-羟基琥珀酰亚胺(“NHS”)、磺基琥珀酰亚胺、羰基二咪唑、磺酰氯、芳基卤化物、磺基琥珀酯、N-羟基琥珀酰亚胺酯、琥珀酰亚胺酯,诸如琥珀酰亚胺琥珀酸酯和/或琥珀酰亚胺丙酸酯、异腈酸酯、硫氰酸酯、碳化二亚胺、苯并三唑碳酸酯、环氧化合物、醛、马来酰亚胺、亚氨酸酯、它们的组合等等。亲电官能团可包括琥珀酰亚胺酯。亲核官能团的示例可包括但不限于-NH2、-SH、-OH、-PH2和-CO-NH-NH2。Hydrogels can be made from one or more hydrogel precursors. Precursors may include monomers and/or macromers. The hydrogel precursor may include electrophile functional groups and/or nucleophile electrophile functional groups. In general, electrophiles can react with nucleophiles to form chemical bonds. The term "functional group" as used herein refers to electrophilic or nucleophilic groups capable of reacting with each other to form chemical bonds. Examples of electrophilic functional groups may include, but are not limited to, N-hydroxysuccinimide ("NHS"), sulfosuccinimide, carbonyldiimidazole, sulfonyl chloride, aryl halide, sulfosuccinate, N-hydroxy Succinimidyl esters, succinimidyl esters such as succinimidyl succinate and/or succinimidyl propionate, isocyanates, thiocyanates, carbodiimides, benzotriazoles Carbonates, epoxies, aldehydes, maleimides, imidates, combinations thereof, and the like. Electrophilic functional groups may include succinimidyl esters. Examples of nucleophilic functional groups may include, but are not limited to,-NH2 , -SH, -OH, -PH2, and -CO-NH-NH2 .
水凝胶可由单个前体或多个前体形成。水凝胶可由第一前体和第二前体形成。第一水凝胶前体和第二水凝胶前体在接触时可原位或在体内形成水凝胶。水凝胶前体一般可指聚合物、官能团、大分子、小分子和/或能够参与反应以形成水凝胶的交联剂。前体可包括例如均匀溶液、不均匀的或在适当溶剂中相分离的溶液,诸如水或缓冲液。缓冲液的pH可为例如约8至约12,诸如约8.2至约9。缓冲液的示例可包括但不限于硼酸盐缓冲液。前体可在乳液中。根据本发明,第一前体可与第二前体反应以形成水凝胶。第一前体可在与第二前体接触时自发地交联。根据本发明,第一前体上的第一组亲电官能团可与第二前体上的第二组亲核官能团反应。当前体混合在允许反应的环境中时(例如,当与pH、温度和/或溶剂相关时),官能团可彼此反应以形成共价键。在前体中的至少一些与不止一个其他的前体反应时,前体可成为交联的。Hydrogels can be formed from a single precursor or from multiple precursors. A hydrogel can be formed from a first precursor and a second precursor. The first hydrogel precursor and the second hydrogel precursor can form a hydrogel in situ or in vivo upon contact. Hydrogel precursors may generally refer to polymers, functional groups, macromolecules, small molecules, and/or crosslinkers capable of participating in reactions to form hydrogels. Precursors may include, for example, homogeneous solutions, heterogeneous or phase-separated solutions in suitable solvents, such as water or buffers. The pH of the buffer may be, for example, from about 8 to about 12, such as from about 8.2 to about 9. Examples of buffers may include, but are not limited to, borate buffers. The precursor may be in an emulsion. According to the present invention, a first precursor can be reacted with a second precursor to form a hydrogel. The first precursor may spontaneously crosslink upon contact with the second precursor. According to the invention, a first set of electrophilic functional groups on a first precursor can react with a second set of nucleophilic functional groups on a second precursor. Functional groups can react with each other to form covalent bonds when the precursors are mixed in an environment that allows the reaction (eg, as related to pH, temperature, and/or solvent). Precursors may become crosslinked when at least some of the precursors react with more than one other precursor.
组织厚度补偿件可包括至少一个单体,所述单体选自3-磺丙基丙烯酸钾盐(“KSPA”)、丙烯酸钠(“NaA”)、N-(三(羟基甲基)甲基)丙烯酰胺(“三丙烯酰基”)和2-丙烯酰胺-2-甲基-1-丙烷磺酸(AMPS)。组织厚度补偿件可包括共聚物,该共聚物包括两个或多个选自KSPA、NaA、三丙烯酰基、AMPS的单体。组织厚度补偿件可包括来源于KSPA、NaA、三丙烯酰基、AMPS的均聚物。组织厚度补偿件可包括可与其共聚的亲水性改性单体。亲水性改性单体可包括甲基丙烯酸甲酯、丙烯酸丁酯、丙烯酸环己酯、苯乙烯、苯乙烯磺酸。The tissue thickness compensator may comprise at least one monomer selected from the group consisting of potassium 3-sulfopropylacrylate ("KSPA"), sodium acrylate ("NaA"), N-(tris(hydroxymethyl)methyl) ) acrylamide ("triacryloyl") and 2-acrylamide-2-methyl-1-propanesulfonic acid (AMPS). The tissue thickness compensator may comprise a copolymer comprising two or more monomers selected from KSPA, NaA, triacryloyl, AMPS. The tissue thickness compensator may comprise homopolymers derived from KSPA, NaA, triacryloyl, AMPS. The tissue thickness compensator may include a hydrophilic modifying monomer copolymerizable therewith. The hydrophilic modifying monomer may include methyl methacrylate, butyl acrylate, cyclohexyl acrylate, styrene, styrene sulfonic acid.
组织厚度补偿件可包括交联剂。交联剂可包括低分子量二或聚乙烯交联剂,诸如乙二醇二丙烯酸酯或二甲基丙烯酸酯、二、三或四乙烯基-乙二醇二丙烯酸酯或二甲基丙烯酸酯、烯丙基(甲基)丙烯酸酯、C2-C8-亚烷基二丙烯酸酯或二甲基丙烯酸酯、二乙烯醚、二乙烯砜、二和三乙烯基苯、三羟甲基丙烷三丙烯酸酯或三甲基丙烯酸酯、季戊四醇四丙烯酸酯或四甲基丙烯酸酯、双酚A二丙烯酸酯或二甲基丙烯酸酯、亚甲基双丙烯酰胺或二甲基丙烯酰胺、乙烯双丙烯酰胺或乙烯二甲基丙烯酰胺、邻苯二甲酸三烯丙酯或邻苯二甲酸二烯丙酯。交联剂可包括N,N'-亚甲基双丙烯酰胺(“MBAA”)。The tissue thickness compensator can include a cross-linking agent. Cross-linking agents may include low molecular weight di- or polyethylene cross-linking agents such as ethylene glycol diacrylate or dimethacrylate, di-, tri- or tetraethylene-ethylene glycol diacrylate or dimethacrylate, Allyl (meth)acrylate, C2 -C8 -alkylene diacrylate or dimethacrylate, divinyl ether, divinylsulfone, di- and trivinylbenzene, trimethylolpropanetri Acrylate or Trimethacrylate, Pentaerythritol Tetraacrylate or Tetramethacrylate, Bisphenol A Diacrylate or Dimethacrylate, Methylenebisacrylamide or Dimethacrylamide, Ethylenebisacrylamide or Ethylene Dimethacrylamide, Triallyl Phthalate, or Diallyl Phthalate. The crosslinking agent may include N,N'-methylenebisacrylamide ("MBAA").
组织厚度补偿件可包括丙烯酸酯和/或甲基丙烯酸酯官能水凝胶、生物相容性光引发剂、烷基-氰基丙烯酸酯、异氰酸酯官能大分子单体中的至少一者、任选地包括胺官能大分子单体、琥珀酰亚胺酯官能大分子单体、任选地包括胺和/或巯基官能大分子单体、环氧基官能大分子单体、任选地包括胺官能大分子单体、蛋白质和/或多肽和醛交联剂的混合物、京尼平(Genipin)和水可溶解的碳化二亚胺、阴离子多糖和多价阳离子。The tissue thickness compensator may comprise at least one of an acrylate and/or methacrylate functional hydrogel, a biocompatible photoinitiator, an alkyl-cyanoacrylate, an isocyanate functional macromer, optionally optionally including amine functional macromers, succinimidyl ester functional macromers, optionally including amine and/or mercapto functional macromers, epoxy functional macromers, optionally including amine functional Mixtures of macromers, proteins and/or peptides and aldehyde crosslinkers, Genipin and water soluble carbodiimides, anionic polysaccharides and polyvalent cations.
组织厚度补偿件可包括不饱和的有机酸单体、丙烯酸取代醇和/或丙烯酰胺。组织厚度补偿件可包括甲基丙烯酸、丙烯酸、甘油丙烯酸酯、甘油甲基丙烯酸酯、2-羟基乙基甲基丙烯酸酯、2-丙烯酸羟乙酯、2-(二甲基氨基乙基)甲基丙烯酸酯、N-乙烯基吡咯烷酮、甲基丙烯酰胺和/或N,N-二甲基丙烯酰胺聚(甲基丙烯酸)。The tissue thickness compensator may include unsaturated organic acid monomers, acrylic substituted alcohols, and/or acrylamide. Tissue thickness compensators may include methacrylic acid, acrylic acid, glycerol acrylate, glycerol methacrylate, 2-hydroxyethyl methacrylate, 2-hydroxyethyl acrylate, 2-(dimethylaminoethyl)methacrylate acrylate, N-vinylpyrrolidone, methacrylamide and/or N,N-dimethylacrylamide poly(methacrylic acid).
组织厚度补偿件可包括增强材料。增强材料可包括以上所述的非合成材料和合成材料中的至少一者。增强材料可包括胶原、明胶、血纤维蛋白、纤维蛋白原、弹性蛋白、角蛋白、白蛋白、羟乙基纤维素、纤维素、氧化纤维素、羟丙基纤维素、羧乙基纤维素、羧甲基纤维素、甲壳质、脱乙酰壳多糖、藻酸盐、聚(乳酸)、聚(乙醇酸)、聚(羟基丁酸酯)、聚(膦嗪)、聚酯、聚乙二醇、聚氧化烯、聚丙烯酰胺、聚甲基丙烯酸羟乙酯、聚乙烯吡咯烷酮、聚乙烯醇、聚(己内酯)、聚(二氧杂环己酮)、聚丙烯酸、聚乙酸酯、聚已内酯、聚丙烯、脂族聚酯、甘油、聚(氨基酸)、共聚(醚-酯)、聚草酸亚烷基二醇酯、聚酰胺、聚(亚氨基碳酸酯)、聚草酸亚烷基二醇酯、聚含氧酸酯、聚原酸酯、聚磷腈以及它们的组合。The tissue thickness compensator may include reinforcing material. The reinforcing material may include at least one of the non-synthetic and synthetic materials described above. Reinforcing materials may include collagen, gelatin, fibrin, fibrinogen, elastin, keratin, albumin, hydroxyethyl cellulose, cellulose, oxidized cellulose, hydroxypropyl cellulose, carboxyethyl cellulose, Carboxymethylcellulose, chitin, chitosan, alginate, poly(lactic acid), poly(glycolic acid), poly(hydroxybutyrate), poly(phospharazine), polyester, polyethylene glycol , polyoxyalkylene, polyacrylamide, polyhydroxyethylmethacrylate, polyvinylpyrrolidone, polyvinyl alcohol, poly(caprolactone), poly(dioxanone), polyacrylic acid, polyacetate, Polycaprolactone, polypropylene, aliphatic polyester, glycerin, poly(amino acid), copoly(ether-ester), polyalkylene oxalate, polyamide, poly(iminocarbonate), polyoxalate Alkyl glycol esters, polyoxyesters, polyorthoesters, polyphosphazenes, and combinations thereof.
组织厚度补偿件可包括包含增强材料的层。组织厚度补偿件的多孔层和/或无孔层可包括增强材料。例如,多孔层可包括增强材料并且无孔层可不包括增强材料。增强层可包括第一无孔层和第二无孔层中间的内层。增强层可包括组织厚度补偿件的外层。增强层可包括组织厚度补偿件的外表面。The tissue thickness compensator may include a layer comprising a reinforcing material. The porous and/or non-porous layers of the tissue thickness compensator may include reinforcing materials. For example, a porous layer may include reinforcement material and a non-porous layer may not include reinforcement material. The reinforcement layer may include an inner layer intermediate the first non-porous layer and the second non-porous layer. The reinforcement layer may comprise the outer layer of the tissue thickness compensator. The reinforcement layer may comprise the outer surface of the tissue thickness compensator.
增强材料可包括网片、单丝、复丝编织物、纤维、垫、毡、颗粒和/或粉剂。增强材料可结合到组织厚度补偿件的层中。增强材料可结合到无孔层和多孔层中的至少一者中。可使用常规技术(诸如针织、编织、梭织和/针织或来形成包括增强材料的网片)。Reinforcing materials may include meshes, monofilaments, multifilament braids, fibers, mats, felts, granules and/or powders. Reinforcing material may be incorporated into the layers of the tissue thickness compensator. A reinforcing material may be incorporated into at least one of the non-porous layer and the porous layer. Conventional techniques such as knitting, weaving, weaving and/or knitting to form the mesh including the reinforcing material may be used.
根据本发明,多个增强材料可以随机方向和/或共同方向取向。共同方向可为例如平行于钉线和垂直于钉线中的一种。例如,单丝和/或复丝编织物可以随机方向和/或共同方向取向。单丝和复丝编织物可与无孔层和/或多孔层相关联。组织厚度补偿件可包括多个在无孔层内以随机方向取向的多个增强纤维。组织厚度补偿件可包括多个在无孔层内以共同方向取向的多个增强纤维。According to the invention, a plurality of reinforcing materials may be oriented in random directions and/or in a common direction. The common direction can be, for example, one of parallel to the staple line and perpendicular to the staple line. For example, monofilament and/or multifilament braids can be oriented in random directions and/or in a common direction. Monofilament and multifilament braids can be associated with non-porous and/or porous layers. The tissue thickness compensator may include a plurality of reinforcing fibers oriented in random directions within the non-porous layer. The tissue thickness compensator may include a plurality of reinforcing fibers oriented in a common direction within the non-porous layer.
参见图199,砧座70300可包括组织厚度补偿件70305,该组织厚度补偿件70305包括密封地封装增强层70310的第一无孔层70307和第二无孔层70309。增强层70310可包括水凝胶,该水凝胶包括嵌入其中的ORC颗粒或纤维,并且无孔层可包括ORC。如图199所示,组织厚度补偿件70305能够适形于砧座70300的轮廓。组织厚度补偿件70305的内层可适形于砧座70300的内表面,其包括形成凹坑70301。Referring to FIG. 199 , an anvil 70300 can include a tissue thickness compensator 70305 that includes a first non-porous layer 70307 and a second non-porous layer 70309 that hermetically encapsulates a reinforcement layer 70310 . The reinforcement layer 70310 may comprise a hydrogel comprising ORC particles or fibers embedded therein, and the non-porous layer may comprise ORC. As shown in FIG. 199 , the tissue thickness compensator 70305 can conform to the contour of the anvil 70300 . The inner layer of the tissue thickness compensator 70305 can conform to the inner surface of the anvil 70300, including forming dimples 70301.
纤维可形成非织造材料,诸如垫和毡。纤维可具有任何适当的长度,例如从0.1mm到100mm和0.4mm到50mm。增强材料可被研磨成粉末。粉末可具有例如从10微米到1厘米的粒度。粉末可结合到组织厚度补偿件中。Fibers can be formed into nonwoven materials such as mats and felts. The fibers may be of any suitable length, for example from 0.1mm to 100mm and 0.4mm to 50mm. Reinforcement materials can be ground into powders. The powder may have a particle size, for example, from 10 microns to 1 centimeter. Powder can be incorporated into the tissue thickness compensator.
组织厚度补偿件可原位形成。水凝胶可原位形成。组织厚度补偿件可通过共价离子和/或疏水键原位形成。物理(非共价)交联可由络合、氢键合、去溶剂化、范德瓦尔斯相互作用、离子键合以及它们的组合引起。化学(共价)交联可通过多个机制中的任一个来实现,所述机制包括:自由基聚合反应、缩聚反应、阴离子或阳离子聚合反应、逐步增长聚合反应、亲电体-亲核体反应以及它们的组合。The tissue thickness compensator can be formed in situ. Hydrogels can be formed in situ. Tissue thickness compensators can be formed in situ by covalent ionic and/or hydrophobic bonds. Physical (non-covalent) crosslinking can result from complexation, hydrogen bonding, desolvation, van der Waals interactions, ionic bonding, and combinations thereof. Chemical (covalent) crosslinking can be achieved by any of a number of mechanisms including: free radical polymerization, polycondensation, anionic or cationic polymerization, step-growth polymerization, electrophile-nucleophile reactions and their combinations.
任选地,组织厚度补偿件的原位形成可包括使两个或更多个前体反应,所述前体被物理地隔开直到原位接触和/或对环境条件作出反应,从而彼此反应以形成水凝胶。原位可聚合的聚合物可由前体制备,所述前体可反应以在手术部位形成聚合物。组织厚度补偿件可通过前体在原位的交联反应形成。前体可包括能够引发用于原位组织厚度补偿件的形成的聚合反应的引发剂。组织厚度补偿件可包括在形成交联水凝胶的应用时可被激活的前体。组织厚度补偿件的原位形成可包括激发至少一个前体以形成化学键,从而形成组织厚度补偿件。任选地,激活可通过在手术部位物理条件、生物条件和/或化学条件的改变来实现,所述条件改变包括但不限于温度、pH、电场、离子强度、酶和/或化学反应、电和/或磁刺激,以及其他生理的和环境变量。前体可接触主体外部并且引入手术部位。Optionally, in situ formation of the tissue thickness compensator may include reacting two or more precursors that are physically separated until contacted in situ and/or are responsive to environmental conditions to react with each other to form hydrogels. In situ polymerizable polymers can be prepared from precursors that can react to form polymers at the surgical site. The tissue thickness compensator can be formed by an in situ cross-linking reaction of the precursors. The precursor may include an initiator capable of initiating a polymerization reaction for formation of the in situ tissue thickness compensator. The tissue thickness compensator can include precursors that can be activated upon application to form a cross-linked hydrogel. Forming the tissue thickness compensator in situ may include exciting at least one precursor to form a chemical bond, thereby forming the tissue thickness compensator. Optionally, activation can be achieved by changes in physical, biological and/or chemical conditions at the surgical site, including but not limited to temperature, pH, electric field, ionic strength, enzymatic and/or chemical reactions, electrical and/or magnetic stimulation, and other physiological and environmental variables. The precursor can contact the exterior of the body and be introduced into the surgical site.
组织厚度补偿件包括能够储存其中至少一个组分的一个或多个封装件或单元。封装件能够储存其中的水凝胶前体。封装件能够储存例如其中的两种组分。封装件能够储存其中的第一水凝胶前体和第二水凝胶前体。第一封装件能够储存其中的第一水凝胶前体,并且第二封装件能够储存其中的第二水凝胶前体。如上所述,封装件可与钉腿对齐或至少基本上对齐从而在钉腿接触封装件时刺穿封装件和/或以其他的方式使封装件破裂。当部署钉时,该封装件可被压缩、压溃、塌缩和/或以其他的方式破裂。封装件破裂之后,储存其中的组分可流出封装件。储存其中的组分可接触其他组分、组织厚度补偿件的层和/或组织。其他的组分可来自相同或不同的封装件,在组织厚度补偿件的层中提供和/或通过临床医生提供至手术部位。作为以上所述的结果,储存在封装件内的组分可提供组织厚度补偿件的膨胀和/或溶胀。The tissue thickness compensator includes one or more enclosures or cells capable of storing at least one component therein. The enclosure is capable of storing the hydrogel precursor therein. The package is capable of storing, for example, two components therein. The enclosure is capable of storing the first hydrogel precursor and the second hydrogel precursor therein. The first enclosure is capable of storing a first hydrogel precursor therein, and the second enclosure is capable of storing a second hydrogel precursor therein. As noted above, the package may be aligned, or at least substantially aligned, with the staple legs to pierce and/or otherwise rupture the package when the staple legs contact the package. The package may be compressed, crushed, collapsed and/or otherwise ruptured when the staples are deployed. Following rupture of the enclosure, the components stored therein may flow out of the enclosure. Components stored therein may contact other components, layers of the tissue thickness compensator and/or tissue. Additional components may be from the same or different packages, provided in layers of the tissue thickness compensator and/or provided to the surgical site by the clinician. As a result of the above, the components stored within the enclosure may provide expansion and/or swelling of the tissue thickness compensator.
组织厚度补偿件可包括包含封装件的层。封装件可包括与层相关联的空隙、凹坑、圆顶、管以及它们的组合。该封装件可包括层中的空隙。层可包括能够附接到彼此的两个层,其中封装件可限定于两个层之间。封装件可包括层表面上的圆顶。例如,封装件的至少一部分可被定位在从层向上延伸的圆顶内。封装件可包括在层内形成的凹坑。封装件的第一部分可包括圆顶,而封装件的第二部分可包括凹坑。封装件可包括在层内嵌入的管。管可包括本文所述的非合成材料和/或合成材料,诸如PLA。组织厚度补偿件可包括可生物吸收的泡沫,诸如ORC,所述可生物吸收的泡沫包括嵌入其中的PLA管,并且该管可封装例如水凝胶。封装件可包括互相不连接的分立单元。封装件中的一个或多个可经由延伸穿过层的一个或多个通路、导管、和/或通道而相互流体连通。A tissue thickness compensator may include a layer comprising an encapsulation. The enclosure may include voids, dimples, domes, tubes, and combinations thereof associated with the layers. The encapsulation may include voids in the layers. A layer may comprise two layers attachable to each other, wherein an encapsulation may be defined between the two layers. The encapsulation may include domes on the surface of the layers. For example, at least a portion of the enclosure may be positioned within a dome extending upwardly from the layer. The encapsulation may include recesses formed in the layers. The first portion of the enclosure may include domes and the second portion of the enclosure may include dimples. The enclosure may include tubes embedded within layers. The tube may comprise non-synthetic and/or synthetic materials as described herein, such as PLA. The tissue thickness compensator may comprise a bioabsorbable foam, such as ORC, that includes a tube of PLA embedded therein, and the tube may encapsulate, for example, a hydrogel. A package may include discrete units that are not connected to each other. One or more of the enclosures may be in fluid communication with each other via one or more vias, conduits, and/or channels extending through the layers.
来自封装件的组分的释放率可由以下所述来控制:例如组织厚度补偿件的厚度、组织厚度补偿件的组成部分、组分的尺寸、组分的亲水性、和/或在组分中的物理的和/或化学相互作用、组织厚度补偿件的组成部分、和/或外科器械。层可包括一个或多个薄段或弱化部分(诸如局部穿孔),例如所述一个或多个薄段或弱化部分可有利于切割层并使封装件破裂。局部穿孔可以不完全延伸穿过层,而在一些情况下,穿孔可完全延伸穿过层。The release rate of the components from the package can be controlled by, for example, the thickness of the tissue thickness compensator, the constituent parts of the tissue thickness compensator, the size of the components, the hydrophilicity of the components, and/or the Physical and/or chemical interactions in, components of tissue thickness compensators, and/or surgical instruments. A layer may include one or more thin sections or weakened portions (such as localized perforations), which may facilitate cutting of the layer and rupture of the encapsulation, for example. Partial perforations may not extend completely through the layer, while in some cases the perforations may extend completely through the layer.
参见图194和图195,组织厚度补偿件70150可包括包含封装件70154的外层70152A和内层70152B。封装件可包含第一被封装组分和第二被封装组分。封装件可独立地包括第一被封装组分和第二被封装组分中的一者。第一被封装组分可与第二被封装组分分开。外层70152A可包括组织接触表面。内层70152B可包括器械接触表面。器械接触表面70152B可以可释放地附接到砧座70156。外层70152A可附接到内层70152B以在外层70152A和内层70152B之间限定空隙。如图194所示,每个封装件70154可包括在内层70152B的器械接触表面上的圆顶。该圆顶可包括局部穿孔以通过钉腿和封装件的破裂促进切割层。如图195所示,砧座70156可包括多个形成凹坑行70158,其中封装件70154的圆顶可与成形凹坑70158对齐。组织接触表面可包括没有圆顶的平坦表面。组织接触表面可包括一个或多个封装件,诸如从其延伸的封装件70154。Referring to FIGS. 194 and 195 , a tissue thickness compensator 70150 can include an outer layer 70152A comprising an encapsulation 70154 and an inner layer 70152B. The package may comprise a first encapsulated component and a second encapsulated component. The package may independently include one of the first encapsulated component and the second encapsulated component. The first encapsulated component can be separated from the second encapsulated component. The outer layer 70152A can include a tissue contacting surface. The inner layer 70152B can include an instrument contacting surface. The instrument contacting surface 70152B can be releasably attached to the anvil 70156. The outer layer 70152A can be attached to the inner layer 70152B to define a void between the outer layer 70152A and the inner layer 70152B. As shown in FIG. 194, each enclosure 70154 can include a dome on the instrument-contacting surface of the inner layer 70152B. The dome may include partial perforations to facilitate cutting of the layer through rupture of the staple legs and package. As shown in FIG. 195 , the anvil 70156 can include a plurality of rows of forming dimples 70158 , wherein the domes of the enclosures 70154 can be aligned with the forming dimples 70158 . The tissue contacting surface may comprise a flat surface without domes. The tissue contacting surface may include one or more enclosures, such as enclosure 70154 extending therefrom.
任选地,砧座可包括组织厚度补偿件,所述组织厚度补偿件包括含具有至少一个微球颗粒的被封装组分。组织厚度补偿件可包括包含第一被封装组分和第二被封装组分的封装件。组织厚度补偿件可包括包含第一微球颗粒和第二微球颗粒的封装件。Optionally, the anvil may include a tissue thickness compensator comprising an encapsulated component having at least one microspheroidal particle. The tissue thickness compensator can include an enclosure comprising a first encapsulated component and a second encapsulated component. The tissue thickness compensator can include an encapsulation comprising first microspherical particles and second microspherical particles.
参见图196,缝合设备可包括砧座70180和钉仓(示于其他附图中)。钉仓的钉70190可在砧座70180移动进入闭合位置时通过砧座70180变形和/或通过将钉70190向闭合砧座70180移动的钉驱动器系统70192变形。钉的腿70194可接触砧座70180,使得钉70190至少部分地变形。砧座70180可包括组织厚度补偿件70182,其包括外层70183A、内层70183B。组织厚度补偿件70182可包括第一被封装组分和第二被封装组分。封装件210185可对齐或至少基本上对齐,使得当钉腿70194穿过组织T和外层70183A而被推动时,钉腿70194可刺穿封装件70185和/或以其他的方式使封装件70185破裂。如图196所示,钉70190C处于完全击发位置,钉70190B处于正被击发的过程中,并且钉70190A处于其未击发位置。钉70190C和70190B的腿已经移动穿过组织T、外层70183A和组织厚度补偿件70182的内层70183B,并且已接触定位在钉仓对面的砧座70180。封装件70185破裂以后,被封装组分可流出并且彼此接触例如体液和/或组织T。被封装组分可反应以形成反应产物(诸如水凝胶),以例如在组织T和钉的基部之间膨胀并且抵靠钉的腿推动组织T。在各种情况下,由于上文所述,组织厚度补偿件能够消除钉截留区域内的任何间隙。Referring to Fig. 196, a stapling apparatus can include an anvil 70180 and a staple cartridge (shown in other figures). The staples 70190 of the staple cartridge can be deformed by the anvil 70180 as the anvil 70180 is moved into the closed position and/or by a staple driver system 70192 that moves the staples 70190 toward the closed anvil 70180. The legs 70194 of the staples can contact the anvil 70180 such that the staples 70190 are at least partially deformed. The anvil 70180 can include a tissue thickness compensator 70182 that includes an outer layer 70183A, an inner layer 70183B. The tissue thickness compensator 70182 can include a first encapsulated component and a second encapsulated component. Encapsulation 210185 can be aligned or at least substantially aligned such that when staple legs 70194 are pushed through tissue T and outer layer 70183A, staple legs 70194 can pierce encapsulation 70185 and/or otherwise rupture encapsulation 70185 . As shown in FIG. 196, staple 70190C is in a fully fired position, staple 70190B is in the process of being fired, and staple 70190A is in its unfired position. The legs of staples 70190C and 70190B have moved through tissue T, outer layer 70183A, and inner layer 70183B of tissue thickness compensator 70182, and have contacted anvil 70180 positioned opposite the staple cartridge. Upon rupture of the enclosure 70185, the encapsulated components may flow out and come into contact with each other, for example bodily fluids and/or tissue T. The encapsulated components can react to form a reaction product, such as a hydrogel, to swell, for example, between the tissue T and the base of the staple and push the tissue T against the legs of the staple. In each case, due to the above, the tissue thickness compensator is able to eliminate any gaps in the staple entrapment area.
组织厚度补偿件可适于与外科器械一起使用。如上所述,组织厚度补偿件可与钉仓和/或砧座相关联。组织厚度补偿件可构造成适于配合钉仓和/或砧座的任何形状、尺寸和/或维度。如本文所述,组织厚度补偿件可以可释放地附接到钉仓和/或砧座。在缝合过程之前以及在缝合过程期间,组织厚度补偿件可以能够保持组织厚度补偿件与钉仓和/或砧座接触的任何机械的和/或化学的方式附接到钉仓和/或砧座。在钉刺穿组织厚度补偿件以后,可从钉仓和/或砧座中移除或释放组织厚度补偿件。当钉仓和/或砧座移动远离组织厚度补偿件时,可从钉仓和/或砧座中移除或释放组织厚度补偿件。A tissue thickness compensator may be adapted for use with a surgical instrument. As noted above, a tissue thickness compensator can be associated with the staple cartridge and/or the anvil. The tissue thickness compensator can be configured to fit any shape, size and/or dimension of the staple cartridge and/or anvil. As described herein, the tissue thickness compensator can be releasably attachable to the staple cartridge and/or the anvil. The tissue thickness compensator may be attached to the staple cartridge and/or the anvil by any mechanical and/or chemical means capable of maintaining the tissue thickness compensator in contact with the staple cartridge and/or the anvil prior to and during the stapling procedure . After the staples have pierced the tissue thickness compensator, the tissue thickness compensator can be removed or released from the staple cartridge and/or the anvil. The tissue thickness compensator can be removed or released from the staple cartridge and/or the anvil as the staple cartridge and/or the anvil are moved away from the tissue thickness compensator.
参见图191-图193,任何缝合设备70118可包括砧座70120和包括击发构件70124、多个钉70128、刀刃70129和组织厚度补偿件70130的钉仓70122。组织厚度补偿件70130可包含至少一种被封装组分。当组织厚度补偿件被压缩、缝合和/或切割时,被封装组分可破散。参见图192,例如,钉70128可部署在未击发位置和击发位置之间,使得钉腿移动穿过组织厚度补偿件70130,穿透组织厚度补偿件70130的底部表面和顶部表面,穿透组织T,并且接触被定位在钉仓70118对面的砧座70120。被封装组分可互相反应,与嵌入和分散在组织厚度补偿件中的亲水性粉末反应和/或与体液反应以使组织厚度补偿件70130膨胀或溶胀。当腿抵靠砧座变形时,每个钉的腿能够捕获组织厚度补偿件70130的一部分和每个钉70128内的组织T的一部分并且对组织T施加压缩力。如图192和图193所示,组织厚度补偿件70130可补偿在每个钉70128内捕获的组织T的厚度。Referring to FIGS. 191-193 , any of the stapling devices 70118 can include an anvil 70120 and a staple cartridge 70122 including a firing member 70124 , a plurality of staples 70128 , a blade 70129 and a tissue thickness compensator 70130 . The tissue thickness compensator 70130 can comprise at least one encapsulated component. When the tissue thickness compensator is compressed, stitched and/or cut, the encapsulated components may break apart. 192, for example, the staples 70128 can be deployed between an unfired position and a fired position such that the staple legs move through the tissue thickness compensator 70130, penetrate the bottom surface and the top surface of the tissue thickness compensator 70130, penetrate the tissue T , and contact the anvil block 70120 positioned opposite the staple cartridge 70118. The encapsulated components can react with each other, with the hydrophilic powder embedded and dispersed in the tissue thickness compensator and/or with bodily fluids to expand or swell the tissue thickness compensator 70130. The legs of each staple can capture a portion of the tissue thickness compensator 70130 and a portion of the tissue T within each staple 70128 and apply a compressive force to the tissue T when the legs are deformed against the anvil. As shown in FIGS. 192 and 193 , tissue thickness compensator 70130 can compensate for the thickness of tissue T captured within each staple 70128 .
参见图197,外科器械70200可包括砧座70205和钉仓70215,所述砧座70205包括上部组织厚度补偿件70210,所述钉仓70215包括具有外层70220和内层70225的下部组织厚度补偿件。上部组织厚度补偿件70210可被定位在目标组织的第一侧上,而下部组织厚度补偿件可被定位在组织的第二侧上。上部组织厚度补偿件70210可包括ORC,下部组织厚度补偿件的外层可包括具有嵌入其中的ORC颗粒的水凝胶,并且下部组织厚度补偿件的内层可包括例如ORC。197, a surgical instrument 70200 can include an anvil 70205 including an upper tissue thickness compensator 70210 and a staple cartridge 70215 including a lower tissue thickness compensator having an outer layer 70220 and an inner layer 70225 . The upper tissue thickness compensator 70210 can be positioned on a first side of the target tissue, while the lower tissue thickness compensator can be positioned on a second side of the tissue. The upper tissue thickness compensator 70210 can comprise ORC, the outer layer of the lower tissue thickness compensator can comprise a hydrogel with ORC particles embedded therein, and the inner layer of the lower tissue thickness compensator can comprise ORC, for example.
参见图200-图202,外科器械70400可包括钉仓70405和砧座70410。钉仓70405可包括组织厚度补偿件70415,其包括可生物吸收的泡沫。可生物吸收的泡沫可包括封装件,其包含被封装组分70420。可生物吸收的泡沫可包括ORC,并且被封装组分可包含例如药物。砧座70410的组织厚度补偿件70415可包括内层70425和外层70430。内层70425可包括可生物吸收的泡沫,并且外层70430可包括例如任选地包括增强材料的水凝胶。在示例性击发序列期间,首先参见图201,滑动件70435可首先接触钉70440A并且开始将钉向上抬起。当滑动件70435朝更远侧被进一步推进时,滑动件70435可开始将钉70440B-D以及任何其他后续钉以相继顺序抬起。滑动件70435可向上驱动钉70440,使得钉的腿接触相对砧座70410并且变形成所需的形状。参照图201示出的击发序列,钉70440A-钉70440C已被移动到它们的完全击发位置,钉70440D处于正被击发的过程中,而钉70420E仍然处于其未击发位置。在示例性击发序列期间,被封装组分70470可通过钉腿而破散。被封装组分70420可来自围绕钉腿的封装件以接触组织T。在各种情况下,组织厚度补偿件额外的压缩可将额外的药物挤出封装件。该药物可立即治疗组织并且可减小组织出血。Referring to FIGS. 200-202 , a surgical instrument 70400 can include a staple cartridge 70405 and an anvil 70410 . The staple cartridge 70405 can include a tissue thickness compensator 70415 comprising bioabsorbable foam. The bioabsorbable foam can include an enclosure comprising encapsulated components 70420. The bioabsorbable foam can include an ORC, and the encapsulated components can include, for example, a drug. The tissue thickness compensator 70415 of the anvil 70410 can include an inner layer 70425 and an outer layer 70430. The inner layer 70425 can comprise a bioabsorbable foam, and the outer layer 70430 can comprise, for example, a hydrogel optionally comprising a reinforcing material. During an exemplary firing sequence, referring first to FIG. 201 , the sled 70435 can first contact the staple 70440A and begin lifting the staple upward. As the sled 70435 is advanced further more distally, the sled 70435 can begin to lift the staples 70440B-D and any other subsequent staples in sequential order. The slider 70435 can drive the staple 70440 upward so that the legs of the staple contact the opposing anvil 70410 and deform into the desired shape. Referring to the firing sequence shown in FIG. 201 , staples 70440A-70440C have been moved to their fully fired positions, staples 70440D are in the process of being fired, and staples 70420E are still in their unfired positions. During an exemplary firing sequence, the encapsulated components 70470 can be broken apart by the staple legs. Encapsulated component 70420 may come in contact with tissue T from an enclosure surrounding the staple legs. In each case, additional compression of the tissue thickness compensator can force additional drug out of the enclosure. The drug treats the tissue immediately and reduces bleeding into the tissue.
在各种情况下,外科医生或其他的临床医生可将流体递送到组织厚度补偿件中以制造包括在其中储存和/或吸收的至少一种药物的组织厚度补偿件。根据本发明,钉仓和/或砧座可包括能够提供通向组织厚度补偿件入口的端口。参见图203,钉仓70500可包括例如在其远侧末端的端口70505。端口70505能够接收针70510,诸如示于图203A中的有孔针。临床医生可将针70510通过端口70505插入到组织厚度补偿件70515中,从而将流体递送至组织厚度补偿件70515。流体可包括例如药物和水凝胶前体。如上所述,当组织厚度补偿件破裂和/或压缩时,流体可从组织厚度补偿件释放到组织。例如,当组织厚度补偿件70515进行生物降解时,药物可从组织厚度补偿件70515中释放。In various circumstances, a surgeon or other clinician may deliver a fluid into the tissue thickness compensator to manufacture the tissue thickness compensator including at least one drug stored and/or absorbed therein. According to the present invention, the staple cartridge and/or the anvil may include a port capable of providing access to the tissue thickness compensator. Referring to Fig. 203, a staple cartridge 70500 can include a port 70505, for example, at a distal end thereof. Port 70505 is capable of receiving a needle 70510, such as the holed needle shown in Figure 203A. A clinician can insert a needle 70510 into the tissue thickness compensator 70515 through the port 70505, thereby delivering fluid to the tissue thickness compensator 70515. Fluids may include, for example, drugs and hydrogel precursors. As described above, when the tissue thickness compensator ruptures and/or compresses, fluid can be released from the tissue thickness compensator to the tissue. For example, a drug can be released from the tissue thickness compensator 70515 as the tissue thickness compensator 70515 biodegrades.
现在参见图14,钉仓(诸如钉仓10000)例如可包括支撑部分10010和可压缩的组织厚度补偿件10020。现在参见图16-图18,支撑部分10010可包括平台表面10011和限定在支撑部分10010中的多个钉腔10012。每个钉腔10012的尺寸例如可设定成并能够在其中可移除地储存钉,诸如钉10030。钉仓10000还可包括多个钉驱动器10040,当钉10030和钉驱动器10040处于其未击发位置时,每个钉驱动器能够支撑钉腔10012内的一个或多个钉10030。例如,首先参见图22和图23,每个钉驱动器10040可包括例如一个或多个支架或槽10041,该支架或槽能够支撑钉并限制钉10030和钉驱动器10040之间的相对运动。再次参见图16,钉仓10000还可包括钉击发滑动件10050;该钉击发滑动件可从钉仓的近侧末端10001运动到钉仓的远侧末端10002,以便依次将钉驱动器10040和钉10030从其未击发位置向被定位在钉仓10000对面的砧座抬起。首先参见图16和图18,每个钉10030可包括基部10031和从基部10031延伸的一个或多个腿10032,其中每个钉可为例如基本U形和基本V形中的至少一者。钉10030能够使得当钉10030处于其未击发位置时,钉腿10032的顶端相对于支撑部分10010的平台表面10011凹陷。钉10030能够使得当钉10030处于其未击发位置时,钉腿10032的顶端相对于支撑部分10010的平台表面10011齐平。钉10030能够使得当钉10030处于其未击发位置时,钉腿10032的顶端或钉腿10032的至少某部分延伸到支撑部分10010的平台表面10011上方。在这种情况下,当钉10030处于其未击发位置时,钉腿10032可延伸到进入并被嵌入到组织厚度补偿件10020中。例如,钉腿10032可例如延伸到平台表面10011上方大约0.075"。钉腿10032可例如延伸到平台表面10011上方大约0.025"和大约0.125"之间的距离。对上文进行进一步描述,组织厚度补偿件10020可包括例如大约0.08"和大约0.125"之间的未压缩厚度。Referring now to FIG. 14 , a staple cartridge, such as staple cartridge 10000 , for example, can include a support portion 10010 and a compressible tissue thickness compensator 10020 . Referring now to FIGS. 16-18 , the support portion 10010 can include a deck surface 10011 and a plurality of staple cavities 10012 defined in the support portion 10010 . Each staple cavity 10012, for example, can be sized and capable of removably storing a staple, such as staple 10030, therein. The staple cartridge 10000 can also include a plurality of staple drivers 10040, each staple driver capable of supporting one or more staples 10030 within the staple cavity 10012 when the staples 10030 and staple drivers 10040 are in their unfired positions. For example, referring first to FIGS. 22 and 23 , each staple driver 10040 can include, for example, one or more brackets or slots 10041 configured to support the staples and limit relative movement between the staples 10030 and the staple drivers 10040 . Referring again to FIG. 16 , the staple cartridge 10000 can also include a staple firing sled 10050; the staple firing sled can be moved from the proximal end 10001 of the staple cartridge to the distal end 10002 of the staple cartridge to sequentially drive the staple drivers 10040 and the staples 10030 The anvil is positioned opposite the staple cartridge 10000 from its unfired position to lift. Referring first to FIGS. 16 and 18 , each staple 10030 can include a base 10031 and one or more legs 10032 extending from the base 10031 , wherein each staple can be at least one of, for example, substantially U-shaped and substantially V-shaped. The staples 10030 are capable of being such that the top ends of the staple legs 10032 are recessed relative to the deck surface 10011 of the support portion 10010 when the staples 10030 are in their unfired position. The staples 10030 are capable of being such that the top ends of the staple legs 10032 are flush with respect to the deck surface 10011 of the support portion 10010 when the staples 10030 are in their unfired position. The staples 10030 can be configured such that the top ends of the staple legs 10032 or at least some portion of the staple legs 10032 extend above the deck surface 10011 of the support portion 10010 when the staples 10030 are in their unfired position. In this case, the staple legs 10032 can extend into and be embedded into the tissue thickness compensator 10020 when the staples 10030 are in their unfired positions. For example, staple legs 10032 can extend, for example, to approximately 0.075" above deck surface 10011. Staple legs 10032 can extend, for example, to a distance between approximately 0.025" and approximately 0.125" above deck surface 10011. Further to the above, tissue thickness compensation The piece 10020 can comprise, for example, an uncompressed thickness of between about 0.08" and about 0.125".
在使用中,对上文进行进一步描述并首先参见图31,砧座诸如砧座10060例如可运动到与钉仓10000相对的闭合位置。如下文更详细所述,砧座10060可将组织抵靠组织厚度补偿件10020定位以及例如将组织厚度补偿件10020压向支撑部分10010的平台表面10011。一旦砧座10060已被恰当定位,则可部署钉10030,同样如图31所示。任选地,如上所述,钉击发滑动件10050可从钉仓10000的近侧末端10001向远侧末端10002移动,如图32所示。当滑动件10050被推进时,滑动件10050可接触钉驱动器10040并在钉腔10012内将钉驱动器10040向上抬起。滑动件10050和钉驱动器10040可各自包括一个或多个斜坡或倾斜表面,该一个或多个斜坡或倾斜表面可协作以使钉驱动器10040从其未击发位置向上运动。例如,参见图19-图23,每个钉驱动器10040可包括至少一个倾斜表面10042,并且滑动件10050可包括一个或多个倾斜表面10052,其能够使得当滑动件10050在钉仓内朝远侧被推进时,倾斜表面10052在倾斜表面10042下滑动。当钉驱动器10040在其各自的钉腔10012内被向上抬起时,钉驱动器10040可将钉10030向上抬起,使得钉10030可通过钉平台10011中的开口从其钉腔10012中露出。在示例性击发序列期间,首先参见图25-图27,滑动件10050可首先接触钉10030a并且开始将钉10030a向上抬起。当滑动件10050朝远侧被进一步推进时,滑动件10050可开始将钉10030b、10030c、10030d、10030e和10030f以及任何其他后续钉按顺序抬起。如图27所示,滑动件10050可将钉10030向上驱动,使得与相对的砧座接触的钉的腿10032变形至期望的形状,并且从支撑部分10010被射出。在各种情况下,作为击发序列的一部分,滑动件10030可同时将多个钉向上运动。参照图27所示的击发序列,钉10030a和10030b已运动至其完全击发位置并且从支撑部分10010被射出,钉10030c和10030d处于被击发的过程中并且被至少部分地容纳在支撑部分10010内,并且钉10030e和10030f仍然处于其未击发位置。In use, as further described above and referring initially to FIG. 31 , an anvil such as anvil 10060 , for example, can be moved to a closed position opposite staple cartridge 10000 . As described in more detail below, the anvil 10060 can position tissue against the tissue thickness compensator 10020 and press the tissue thickness compensator 10020 against the deck surface 10011 of the support portion 10010, for example. Once the anvil 10060 has been properly positioned, the staples 10030 can be deployed, also as shown in FIG. 31 . Optionally, as described above, the staple firing sled 10050 is movable from the proximal end 10001 to the distal end 10002 of the staple cartridge 10000, as shown in FIG. 32 . When the sled 10050 is advanced, the sled 10050 can contact the staple drivers 10040 and lift the staple drivers 10040 upward within the staple cavities 10012. The sled 10050 and the staple drivers 10040 can each include one or more ramps or inclined surfaces that can cooperate to move the staple drivers 10040 upwardly from their unfired positions. For example, referring to FIGS. 19-23 , each staple driver 10040 can include at least one angled surface 10042, and the sled 10050 can include one or more angled surfaces 10052 that enable When pushed, the sloped surface 10052 slides under the sloped surface 10042 . As the staple drivers 10040 are lifted upwardly within their respective staple cavities 10012, the staple drivers 10040 can lift the staples 10030 upwardly such that the staples 10030 can emerge from their staple cavities 10012 through openings in the staple platform 10011. During an exemplary firing sequence, referring first to FIGS. 25-27 , the sled 10050 can first contact the staple 10030a and begin lifting the staple 10030a upward. As the sled 10050 is advanced further distally, the sled 10050 can begin to lift the staples 10030b, 10030c, 10030d, 10030e, and 10030f and any other subsequent staples in sequence. As shown in FIG. 27 , the sled 10050 can drive the staples 10030 upward so that the legs 10032 of the staples in contact with the opposing anvil deform to the desired shape and are ejected from the support portion 10010 . In various instances, the sled 10030 can move multiple staples upward simultaneously as part of a firing sequence. Referring to the firing sequence shown in FIG. 27, staples 10030a and 10030b have been moved to their fully fired positions and ejected from support portion 10010, staples 10030c and 10030d are in the process of being fired and are at least partially contained within support portion 10010, And staples 10030e and 10030f are still in their unfired positions.
如上所述并参见图33,当钉10030处于其未击发位置时,钉10030的钉腿10032可延伸到支撑部分10010的平台表面10011上方。进一步参照图27所示的该击发序列,钉10030e和10030f示出为处于其未击发位置,并且其钉腿10032延伸到平台表面10011上方并且延伸到组织厚度补偿件10020中。当钉10030处于其未击发位置时,钉腿10032的顶端或钉腿10032的任何其他部分可能不凸穿组织厚度补偿件10020的顶部组织接触表面10021。如图27所示,当钉10030从其未击发位置运动到其击发位置时,钉腿的顶端可凸穿组织接触表面10032。钉腿10032的顶端可包括能够切割和穿透组织厚度补偿件10020的锋利的顶端。组织厚度补偿件10020可包括多个孔,所述多个孔能够接收钉腿10032并且允许钉腿10032相对于组织厚度补偿件10020滑动。支撑部分10010还可包括从平台表面10011延伸的多个引导件10013。引导件10013可被定位成邻近平台表面10011的钉腔开口,使得钉腿10032可至少部分地由引导件10013支撑。引导件10013可被定位在钉腔开口的近侧末端和/或远侧末端处。根据本发明,第一引导件10013可被定位在每个钉腔开口的第一末端,并且第二引导件10013可被定位在每个钉腔开口的第二末端,使得每个第一引导件10013可支撑钉10030的第一钉腿10032,并且每个第二引导件10013可支撑钉的第二钉腿10032。参见图33,每个引导件10013可包括沟槽或狭槽,诸如沟槽10016,例如钉腿10032可被滑动地接收在该沟槽10016中。任选地,每个引导件10013可包括可从平台表面10011延伸并可延伸到组织厚度补偿件10020中的防滑钉、突起、和/或长钉。如下文更详细所述,防滑钉、突起、和/或长钉可减小组织厚度补偿件10020和支撑部分10010之间的相对运动。钉腿10032的顶端可被定位在引导件10013中并且当钉10030处于其未击发位置时可不延伸到引导件10013的顶部表面上方。例如,引导件10013可限定引导高度,并且当钉10030处于其未击发位置时可不延伸到该引导高度上方。As noted above and referring to FIG. 33 , the legs 10032 of the staples 10030 can extend above the deck surface 10011 of the support portion 10010 when the staples 10030 are in their unfired positions. With further reference to this firing sequence shown in FIG. 27 , staples 10030 e and 10030 f are shown in their unfired positions with their staple legs 10032 extending above deck surface 10011 and into tissue thickness compensator 10020 . The top ends of the staple legs 10032 or any other portion of the staple legs 10032 may not protrude through the top tissue contacting surface 10021 of the tissue thickness compensator 10020 when the staples 10030 are in their unfired positions. As shown in FIG. 27, the tips of the staple legs can protrude through the tissue contacting surface 10032 when the staples 10030 are moved from their unfired positions to their fired positions. The tips of the staple legs 10032 can include sharp tips capable of cutting and penetrating the tissue thickness compensator 10020 . The tissue thickness compensator 10020 can include a plurality of apertures configured to receive the staple legs 10032 and allow the staple legs 10032 to slide relative to the tissue thickness compensator 10020 . The support portion 10010 may also include a plurality of guides 10013 extending from the platform surface 10011 . The guides 10013 can be positioned adjacent to the staple cavity openings of the deck surface 10011 such that the staple legs 10032 can be at least partially supported by the guides 10013 . The guide 10013 can be positioned at the proximal end and/or the distal end of the staple cavity opening. According to the present invention, the first guide 10013 can be positioned at the first end of each staple cavity opening, and the second guide 10013 can be positioned at the second end of each staple cavity opening such that each first guide 10013 can support a first staple leg 10032 of a staple 10030 and each second guide 10013 can support a second staple leg 10032 of a staple. Referring to Fig. 33, each guide 10013 can include a groove or slot, such as a groove 10016, into which a staple leg 10032 can be slidably received, for example. Optionally, each guide 10013 can include a cleat, protrusion, and/or spike extendable from the deck surface 10011 and into the tissue thickness compensator 10020 . As described in more detail below, the cleats, protrusions, and/or spikes can reduce relative movement between the tissue thickness compensator 10020 and the support portion 10010 . The top ends of the staple legs 10032 can be positioned in the guides 10013 and may not extend above the top surface of the guides 10013 when the staples 10030 are in their unfired positions. For example, the guides 10013 can define a guide height and may not extend above the guide height when the staples 10030 are in their unfired positions.
根据本发明,组织厚度补偿件(诸如组织厚度补偿件10020)例如可由单个材料片构成。组织厚度补偿件可包括连续材料片,该连续材料片可覆盖支撑部分10010的整个顶部平台表面10011,或作为另外一种选择,覆盖小于整个平台表面10011。材料片可覆盖支撑部分10010中的钉腔开口,然而作为另外一种选择,材料片可包括可与钉腔开口对齐的或至少部分对齐的开口。根据本发明,组织厚度补偿件可由多层材料构成。现在参见图15,组织厚度补偿件可包括可压缩芯和围绕可压缩芯的包裹物。包裹物10022能够将可压缩芯可释放地保持到支撑部分10010。例如,支撑部分10010可包括例如从其延伸的一个或多个突出部,诸如突出部10014(图18),该突出部可被接收在一个或多个孔和/或狭槽内,诸如限定在包裹物10022中的孔10024内。突出部10014和孔10024能够使得突出部10014可将包裹物10022保持到支撑部分10010。突出部10014的端部可例如通过热熔处理而变形,以便扩大突出部10014的端部,并且因此限制包裹物10022和支撑部分10010之间的相对运动。包裹物10022可包括一个或多个穿孔10025,其可有利于将包裹物10022从支撑部分10010释放,如图15所示。现在参见图24,组织厚度补偿件可包括包裹物10222,该包裹物包括多个孔10223,其中孔10223可与支撑部分10010中的钉腔开口对齐或至少部分对齐。组织厚度补偿件的芯还可包括与包裹物10222中的孔10223对齐或至少部分对齐的孔。作为另外一种选择,组织厚度补偿件的芯可包括连续主体并且可延伸到孔10223的下面,使得连续主体覆盖平台表面10011中的钉腔开口。In accordance with the present invention, a tissue thickness compensator, such as tissue thickness compensator 10020, for example, can be constructed from a single sheet of material. The tissue thickness compensator may comprise a continuous sheet of material that may cover the entire top deck surface 10011 of the support portion 10010 , or alternatively less than the entire deck surface 10011 . The sheet of material may cover the staple cavity openings in the support portion 10010, however alternatively the sheet of material may include openings that may be aligned, or at least partially aligned, with the staple cavity openings. According to the present invention, the tissue thickness compensator may consist of multiple layers of material. Referring now to FIG. 15, a tissue thickness compensator may include a compressible core and a wrap surrounding the compressible core. The wrap 10022 is capable of releasably retaining the compressible core to the support portion 10010 . For example, support portion 10010 can include, for example, extending therefrom one or more protrusions, such as protrusion 10014 ( FIG. 18 ), which can be received within one or more holes and/or slots, such as defined in In the hole 10024 in the wrapping 10022. The protrusion 10014 and hole 10024 enable the protrusion 10014 to retain the wrap 10022 to the support portion 10010 . The ends of the protrusions 10014 may be deformed, such as by heat staking, so as to enlarge the ends of the protrusions 10014 and thereby limit relative movement between the wrap 10022 and the support portion 10010 . The wrap 10022 can include one or more perforations 10025, which can facilitate releasing the wrap 10022 from the support portion 10010, as shown in FIG. 15 . Referring now to FIG. 24 , the tissue thickness compensator can include a wrap 10222 that includes a plurality of holes 10223 , wherein the holes 10223 can be aligned, or at least partially aligned, with the staple cavity openings in the support portion 10010 . The core of the tissue thickness compensator may also include holes aligned, or at least partially aligned, with the holes 10223 in the wrap 10222. Alternatively, the core of the tissue thickness compensator may comprise a continuous body and may extend below the holes 10223 such that the continuous body covers the staple cavity openings in the deck surface 10011.
任选地,如上所述,组织厚度补偿件可包括用于将可压缩芯可释放地保持到支撑部分10010的包裹物。例如,参见图16,钉仓还可包括保持器夹具10026,该保持器夹具能够抑制包裹物和可压缩芯过早地与支撑部分10010分离。任选地,每个保持器夹具10026可包括能够接收从支撑部分10010延伸的突出部10014的孔10028,使得保持器夹具10026可被保持到支撑部分10010。保持器夹具10026可各自包括至少一个平底部分10027,该平底部分可延伸到支撑部分10010的下面并在支撑部分10010内支撑并保持钉驱动器10040。如上所述,组织厚度补偿件可通过钉10030可移除地附接至支撑部分10010。更具体地讲,还如上所述,当钉10030处于其未击发位置时,钉10030的腿可延伸到组织厚度补偿件10020中,并因此将组织厚度补偿件10020可释放地保持到支撑部分10010。钉10030的腿可与其相应的钉腔10012的侧壁接触,其中,由于钉腿10032和侧壁之间的摩擦,钉10030和组织厚度补偿件10020可被保持在适当位置,直到钉10030从钉仓10000被部署。当钉10030被部署后,组织厚度补偿件10020可被捕获在钉10030内并且抵靠缝合的组织T被保持。当砧座随后运动到打开位置以释放组织T时,支撑部分10010可运动远离已固定至组织的组织厚度补偿件10020。可使用粘合剂以将组织厚度补偿件10020可移除地保持到支撑部分10010。可使用两部分粘合剂,其中,粘合剂的第一部分可被放置到平台表面10011上,并且粘合剂的第二部分可被放置到组织厚度补偿件10020上,使得当组织厚度补偿件10020紧贴平台表面10011放置时,第一部分可接触第二部分以启用粘合剂并将组织厚度补偿件10020可分离地结合至支撑部分10010。任选地,可使用任何其他合适的方法将组织厚度补偿件可分离地保持到钉仓的支撑部分。Optionally, the tissue thickness compensator may include a wrap for releasably retaining the compressible core to the support portion 10010, as described above. For example, referring to FIG. 16 , the staple cartridge can also include a retainer clip 10026 that can inhibit premature separation of the wrap and compressible core from the support portion 10010 . Optionally, each retainer clip 10026 can include an aperture 10028 configured to receive a protrusion 10014 extending from the support portion 10010 such that the retainer clip 10026 can be retained to the support portion 10010 . Retainer clips 10026 can each include at least one flat bottom portion 10027 that can extend below support portion 10010 and support and retain staple drivers 10040 within support portion 10010 . As described above, the tissue thickness compensator can be removably attached to the support portion 10010 by the staples 10030 . More particularly, as also described above, when the staples 10030 are in their unfired positions, the legs of the staples 10030 can extend into the tissue thickness compensator 10020 and thereby releasably retain the tissue thickness compensator 10020 to the support portion 10010 . The legs of the staples 10030 can be in contact with the sidewalls of their respective staple cavities 10012, wherein the staples 10030 and the tissue thickness compensator 10020 can be held in place due to friction between the staple legs 10032 and the sidewalls until the staples 10030 are released from the staples. Pod 10000 is deployed. The tissue thickness compensator 10020 can be captured within the staple 10030 and held against the stapled tissue T after the staple 10030 is deployed. When the anvil is subsequently moved to the open position to release the tissue T, the support portion 10010 can be moved away from the tissue thickness compensator 10020 secured to the tissue. An adhesive may be used to removably retain the tissue thickness compensator 10020 to the support portion 10010. A two-part adhesive can be used, wherein a first part of the adhesive can be placed on the deck surface 10011 and a second part of the adhesive can be placed on the tissue thickness compensator 10020 such that when the tissue thickness compensator When 10020 is placed against deck surface 10011 , the first portion can contact the second portion to activate the adhesive and detachably couple tissue thickness compensator 10020 to support portion 10010 . Optionally, any other suitable method may be used to detachably retain the tissue thickness compensator to the support portion of the staple cartridge.
对上文进行进一步描述,滑动件10050可从近侧末端10001被推进到远侧末端10002以完全部署被容纳在钉仓10000内的所有钉10030。现在参见图56-图60,滑动件10050可在支撑部分10010内的纵向腔体10016中由击发构件或外科缝合器的刀杆10052朝远侧推进。在使用中,钉仓10000可被插入外科缝合器的钳口中的钉仓通道内,例如钉仓通道10070内,并且击发构件10052可被推进到与滑动件10050接触,如图56所示。当滑动件10050由击发构件10052朝远侧推进时,滑动件10050可接触最近侧的钉驱动器或驱动器10040,并且将钉10030从仓体10010击发或射出,如上所述。如图56所示,击发构件10052还可包括切割刃10053,当钉10030被击发时,该切割刃可通过支撑部分10010中的刀狭槽朝远侧被推进。根据本发明,相应的刀狭槽可延伸穿过被定位在钉仓10000对面的砧座,使得切割刃10053可在砧座和支撑部分10010之间延伸并切割定位在其间的组织和组织厚度补偿件。在各种情况下,滑动件10050可由击发构件10052朝远侧推进,直到滑动件10050到达钉仓10000的远侧末端10002,如图58所示。此时,击发构件10052可朝近侧回缩。滑动件10050可随击发构件10052朝近侧回缩,但是现在参见图59,当击发构件10052回缩时,滑动件10050可被留在钉仓10000的远侧末端10002中。一旦击发构件10052已充分回缩,砧座可被再次打开,组织厚度补偿件10020可与支撑部分10010分离,并且已耗尽钉仓10000的剩余的非植入部分,包括支撑部分10010,可从钉仓通道10070中被移除。Further to the above, the sled 10050 can be advanced from the proximal end 10001 to the distal end 10002 to fully deploy all of the staples 10030 contained within the staple cartridge 10000 . Referring now to FIGS. 56-60 , the sled 10050 can be advanced distally within the longitudinal cavity 10016 within the support portion 10010 by a firing member or a knife bar 10052 of a surgical stapler. In use, staple cartridge 10000 can be inserted into a staple cartridge channel in the jaws of a surgical stapler, such as staple cartridge channel 10070, and firing member 10052 can be advanced into contact with sled 10050, as shown in FIG. When the sled 10050 is advanced distally by the firing member 10052, the sled 10050 can contact the proximal-most staple driver or driver 10040 and fire or eject the staples 10030 from the cartridge body 10010, as described above. As shown in FIG. 56, the firing member 10052 can also include a cutting edge 10053 that can be advanced distally through the knife slot in the support portion 10010 when the staples 10030 are fired. According to the present invention, a corresponding knife slot can extend through an anvil positioned opposite the staple cartridge 10000 such that the cutting edge 10053 can extend between the anvil and the support portion 10010 and cut tissue and tissue thickness compensation positioned therebetween. pieces. In various circumstances, the sled 10050 can be advanced distally by the firing member 10052 until the sled 10050 reaches the distal end 10002 of the staple cartridge 10000, as shown in FIG. 58 . At this point, the firing member 10052 can be retracted proximally. The sled 10050 can be retracted proximally with the firing member 10052, but referring now to FIG. 59, the sled 10050 can be left in the distal end 10002 of the staple cartridge 10000 when the firing member 10052 is retracted. Once the firing member 10052 has been sufficiently retracted, the anvil can be opened again, the tissue thickness compensator 10020 can be separated from the support portion 10010, and the remaining non-implanted portion of the depleted staple cartridge 10000, including the support portion 10010, can be removed from The staple cartridge channel 10070 is removed.
当已耗尽钉仓10000已从钉仓通道中被移除后,对上文进行进一步描述,新的钉仓10000或任何其他合适的钉仓可被插入钉仓通道10070中。对上文进行进一步描述,钉仓通道10070、击发构件10052、和/或钉仓10000可包括协作结构,该协作结构可在新的未击发钉仓10000没有被定位在钉仓通道10070中时防止击发构件10052再次或随后朝远侧被推进。更具体地讲,再次参见图56,当击发构件10052被推进到与滑动件10050接触时,并且当滑动件10050处于其近侧未击发位置时,击发构件10052的支撑鼻部10055可被定位在滑动件10050上的支撑凸缘10056上和/或之上,使得击发构件10052被保持在足够向上的位置,以防止从击发构件10052延伸的锁或横梁10054落入被限定在钉仓通道内的锁凹槽中。由于锁10054不会落入锁凹槽时,在此类情况下,当击发构件10052被推进时,锁10054可不邻接锁凹槽的远侧侧壁10057。当击发构件10052将滑动件10050朝远侧推动时,击发构件10052可由于靠在支撑凸缘10056上的支撑鼻部10055而被支撑在其向上击发位置。当击发构件10052相对于滑动件10050回缩时,如上所述并如图59所示,当支撑鼻部10055不再靠在滑动件10050的支撑凸缘10056上时,击发构件10052可从其向上位置下落。例如,外科钉可包括能够将击发构件10052偏置到其向下位置的弹簧10058和/或任何其他合适的偏置元件。一旦击发构件10052已完全回缩,如图60所示,击发构件10052不能再次穿过用尽的钉仓10000朝远侧被推进。更具体地讲,当此时处于操作顺序的滑动件10050已被留在钉仓10000的远侧末端10002处时,击发构件10052不能被滑动件10050保持在其上部位置。因此,如上所述,如果击发构件10052在没有替换钉仓的情况下被再次推进,则锁横梁10054将接触锁凹槽的侧壁10057,这将防止击发构件10052再次朝远侧被推进到钉仓10000中。换句话讲,一旦用尽的钉仓10000已被新的钉仓替换,新的钉仓将具有近侧定位的滑动件10050,该近侧定位的滑动件可将击发构件10052保持在其向上位置,并且使击发构件10052再次朝远侧被推进。After the spent staple cartridge 10000 has been removed from the staple cartridge channel, further to the above, a new staple cartridge 10000 or any other suitable staple cartridge can be inserted into the staple cartridge channel 10070. Further to the above, the staple cartridge channel 10070, the firing member 10052, and/or the staple cartridge 10000 can include cooperating structures that prevent a new unfired staple cartridge 10000 from being positioned in the staple cartridge channel 10070. The firing member 10052 is again or subsequently advanced distally. More specifically, referring again to FIG. 56, when the firing member 10052 is advanced into contact with the sled 10050, and when the sled 10050 is in its proximal unfired position, the support nose 10055 of the firing member 10052 can be positioned at On and/or over the support flange 10056 on the sled 10050 such that the firing member 10052 is held in a sufficiently upward position to prevent the lock or beam 10054 extending from the firing member 10052 from falling into the lock defined in the staple cartridge channel. in the lock groove. Since the lock 10054 does not fall into the lock groove, in such cases the lock 10054 may not abut the distal sidewall 10057 of the lock groove when the firing member 10052 is advanced. As the firing member 10052 pushes the sled 10050 distally, the firing member 10052 can be supported in its upward firing position due to the support nose 10055 resting on the support flange 10056 . When the firing member 10052 is retracted relative to the slide 10050, as described above and as shown in FIG. location drop. For example, the surgical staple may include a spring 10058 and/or any other suitable biasing element capable of biasing the firing member 10052 to its downward position. Once the firing member 10052 has been fully retracted, as shown in FIG. 60 , the firing member 10052 cannot be advanced distally through the spent staple cartridge 10000 again. More specifically, the firing member 10052 cannot be held in its upper position by the sled 10050 when the sled 10050 in the operating sequence has been left at the distal end 10002 of the staple cartridge 10000 at this time. Therefore, as described above, if the firing member 10052 is advanced again without replacing the staple cartridge, the lock beam 10054 will contact the sidewall 10057 of the lock groove, which will prevent the firing member 10052 from being advanced further distally into the staples. The warehouse is 10000. In other words, once the spent staple cartridge 10000 has been replaced by a new staple cartridge, the new staple cartridge will have a proximally positioned slide 10050 that can hold the firing member 10052 upward position, and the firing member 10052 is advanced distally again.
如上所述,滑动件10050能够将钉驱动器10040在第一未击发位置和第二击发位置之间运动,以便将钉10030从支撑部分10010中射出。在钉10030已从支撑部分10010被射出以后,钉驱动器10040可被容纳在钉腔10012内。支撑部分10010可包括能够阻止钉驱动器10040从钉腔10012中射出或掉出的一个或多个保持结构。作为另外一种选择,滑动件10050能够将钉驱动器10040从具有钉10030的支撑部分10010中射出。例如,钉驱动器10040可由例如可生物吸收的和/或生物相容性材料构成,诸如聚醚酰亚胺(Ultem)。钉驱动器可附接到钉10030。例如,钉驱动器可被模塑在每个钉10030的基部之上和/或周围,使得驱动器与钉一体形成。2006年9月29日提交的名称为“SURGICAL STAPLES HAVING COMPRESSIBLE ORCRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FORDEPLOYING THE SAME”美国专利申请序列号11/541,123全文以引用方式并入本文。As described above, the sled 10050 is configured to move the staple drivers 10040 between the first unfired position and the second fired position in order to eject the staples 10030 from the support portion 10010. After the staples 10030 have been ejected from the support portion 10010, the staple drivers 10040 can be received within the staple cavities 10012. Support portion 10010 can include one or more retaining structures capable of preventing staple drivers 10040 from being ejected or dropped out of staple cavities 10012 . Alternatively, the slider 10050 is capable of ejecting the staple drivers 10040 from the support portion 10010 with the staples 10030 thereon. For example, staple drivers 10040 can be constructed of, for example, bioabsorbable and/or biocompatible materials, such as polyetherimide (Ultem). Staple drivers can be attached to the staples 10030. For example, a staple driver can be molded on and/or around the base of each staple 10030 such that the driver is integrally formed with the staple. U.S. Patent Application Serial No. 11/541,123, filed September 29, 2006, entitled "SURGICAL STAPLES HAVING COMPRESSIBLE ORCRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FORDEPLOYING THE SAME," is hereby incorporated by reference in its entirety.
如上所述,外科缝合器械可包括能够接收钉仓的钉仓通道、可旋转地联接到钉仓通道的砧座、和包括刀刃的击发构件,该击发构件可相对于砧座和钉仓通道运动。在使用中,钉仓可被定位在钉仓通道内,并且当钉仓被至少部分地消耗后,钉仓可从钉仓通道移除并被新的钉仓替换。例如,外科缝合器械的钉仓通道、砧座、和/或击发构件可与替换钉仓一起被重复使用。作为另外一种选择,钉仓可包括一次性加载单元组件的一部分,该一次性加载单元组件例如可包括钉仓通道、砧座、和/或击发构件,这些可作为替换一次性加载单元组件的一部分随钉仓一起被替换。某些一次性加载单元组件公开于2008年2月15日提交的名称为“END EFFECTOR COUPLING ARRANGEMENTS FOR A SURGICAL CUTTING AND STAPLINGINSTRUMENT”的美国专利申请序列号12/031,817中,该专利申请的全部公开内容以引用方式并入本文。As described above, a surgical stapling instrument may include a staple cartridge channel configured to receive a staple cartridge, an anvil rotatably coupled to the staple cartridge channel, and a firing member including a blade movable relative to the anvil and the staple cartridge channel . In use, a staple cartridge can be positioned within the staple cartridge channel, and when the staple cartridge is at least partially consumed, the staple cartridge can be removed from the staple cartridge channel and replaced with a new staple cartridge. For example, the staple cartridge channel, anvil, and/or firing member of a surgical stapling instrument may be reused with a replacement staple cartridge. Alternatively, the staple cartridge may comprise a portion of a disposable loading unit assembly, which may include, for example, a staple cartridge channel, an anvil, and/or a firing member, which may serve as part of a replacement disposable loading unit assembly. A part is replaced with the staple cartridge. Certain disposable loading unit assemblies are disclosed in U.S. Patent Application Serial No. 12/031,817, entitled "END EFFECTOR COUPLING ARRANGEMENTS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT," filed February 15, 2008, the entire disclosure of which is set forth in Incorporated herein by reference.
组织厚度补偿件可包括可挤出、可浇铸和/或可模塑的组合物,其包括本文所述的合成材料和/或非合成材料中的至少一种。组织厚度补偿件可包括具有两层或更多层的膜或片。组织厚度补偿件可使用常规方法获得,例如混合、共混、组合、喷涂、芯吸、溶剂蒸发、浸渍、刷涂、气相沉淀、挤出、压延、浇铸、模塑等等。挤出时,开口可以包括至少一个开口的模具的形式为露出的挤出物赋予形状。压延时,开口可包括两个辊之间的辊隙。常规的模塑方法可包括但不限于吹塑、注塑、泡沫注射、压塑、热成形、挤出、发泡挤出、薄膜吹塑、压延、旋压、溶剂熔接,涂布方法诸如浸涂和旋涂、溶液流延和薄膜铸塑、增塑溶胶加工(包括刮刀涂布、辊涂和浇铸),以及它们的组合。注塑时,开口可包括喷嘴和/或通道/流道和/或模具腔体和特征结构。压塑时,组合物可定位在模具腔体内,加热到合适的温度,并通过在相对高压下受到压缩而成形。浇铸时,组合物可包含液体或浆液,其注入或以其他的方式提供到模具或物体的里面、上面和/或周围,以复制模具或物体的特征结构。浇铸后,组合物可被干燥、冷却和/或固化以形成固体。The tissue thickness compensator may comprise an extrudable, castable and/or moldable composition comprising at least one of the synthetic and/or non-synthetic materials described herein. The tissue thickness compensator may comprise a film or sheet having two or more layers. The tissue thickness compensator can be obtained using conventional methods such as mixing, blending, combining, spraying, wicking, solvent evaporation, dipping, brushing, vapor deposition, extrusion, calendering, casting, molding, and the like. Upon extrusion, the opening may be in the form of a die comprising at least one opening to impart shape to the exposed extrudate. When calendering, the opening may comprise a nip between two rolls. Conventional molding methods may include, but are not limited to, blow molding, injection molding, foam injection, compression molding, thermoforming, extrusion, foam extrusion, film blowing, calendering, spinning, solvent welding, coating methods such as dip coating and spin coating, solution casting and film casting, plastisol processing (including knife coating, roll coating and casting), and combinations thereof. In injection molding, openings may include nozzles and/or channels/runners and/or mold cavities and features. In compression molding, a composition may be positioned within a mold cavity, heated to a suitable temperature, and shaped by being compressed under relatively high pressure. When casting, the composition may comprise a liquid or slurry that is poured or otherwise provided into, onto and/or around a mold or object to replicate the features of the mold or object. After casting, the composition can be dried, cooled and/or solidified to form a solid.
根据本发明,制造组织厚度补偿件的方法可大体包括:提供组织厚度补偿件组合物,液化组合物以使其可流动,以及将熔融、半熔融或塑性状态的组合物形成为具有期望厚度的层和/或膜。参见图198A,组织厚度补偿件可通过以下步骤制成:在水性溶液中溶解水凝胶前体,在其中分散生物相容性颗粒和/或纤维,提供其中具有生物相容性颗粒的模具,将溶液提供到模具中,使活化剂和溶液接触,以及固化溶液以形成组织厚度补偿件,该组织厚度补偿件包括包含生物相容性颗粒的外层和包含嵌入其中的生物相容性颗粒的内层。如198图A所示,可将生物相容性层70250提供在模具70260的底部,接着可将其中设置有生物相容性颗粒70257的水凝胶前体70255的水性溶液提供至模具70260,并且可将水性溶液固化以形成组织厚度补偿件,该组织厚度补偿件具有包含生物相容性材料(诸如ORC)的第一层,以及包含其中设置有生物相容性纤维(诸如ORC纤维)的水凝胶的第二层。组织厚度补偿件可包括泡沫,所述泡沫包括含生物相容性颗粒的外层和含嵌入其中的生物相容性颗粒的内层。组织厚度补偿件可通过以下步骤制造:在水中溶解藻酸钠,在其中分散ORC颗粒,提供其中具有ORC颗粒的模具,将溶液倒入模具,喷涂或注入氯化钙以接触溶液,从而引发藻酸钠的交联,冷冻干燥水凝胶以形成组织厚度补偿件,其包括包含ORC的外层和包含嵌入于其中的水凝胶和ORC颗粒的内层。According to the present invention, a method of making a tissue thickness compensator may generally include providing a tissue thickness compensator composition, liquefying the composition to render it flowable, and forming the composition in a molten, semi-molten, or plastic state into a tissue having a desired thickness. layer and/or film. Referring to Figure 198A, a tissue thickness compensator can be made by dissolving a hydrogel precursor in an aqueous solution, dispersing biocompatible particles and/or fibers therein, providing a mold with the biocompatible particles therein, providing the solution into the mold, contacting the activating agent with the solution, and curing the solution to form a tissue thickness compensator comprising an outer layer comprising biocompatible particles and an outer layer comprising biocompatible particles embedded therein. inner layer. As shown in Figure A of 198, a biocompatible layer 70250 can be provided at the bottom of a mold 70260, then an aqueous solution of a hydrogel precursor 70255 with biocompatible particles 70257 disposed therein can be provided to the mold 70260, and The aqueous solution can be cured to form a tissue thickness compensator having a first layer comprising a biocompatible material such as ORC, and a layer comprising water with biocompatible fibers such as ORC fibers disposed therein. The second layer of gel. The tissue thickness compensator may comprise a foam comprising an outer layer comprising biocompatible particles and an inner layer comprising biocompatible particles embedded therein. The tissue thickness compensator can be manufactured by dissolving sodium alginate in water, dispersing ORC particles in it, providing a mold with ORC particles in it, pouring the solution into the mold, spraying or injecting calcium chloride to contact the solution, thereby initiating algae The cross-linked, freeze-dried hydrogel to form a tissue thickness compensator comprising an outer layer comprising ORC and an inner layer comprising hydrogel and ORC particles embedded therein.
参见图198B,制造三层组织厚度补偿件的方法可大体包括:在第一水性溶液中溶解第一水凝胶前体,在第一水性溶液中分散生物相容性颗粒和/或纤维,提供其中具有生物相容性颗粒的第一层70250的模具70260,将第一水性溶液提供到模具中,使活化剂和第一水性溶液接触,固化第一水性溶液以形成第二层70255,在第二水性溶液中溶解第二水凝胶前体,将第二水性溶液提供到模具中,固化第二水性溶液以形成第三层70265。三层组织厚度补偿件可通过以下方法制造:在水中溶解藻酸钠以形成第一水性溶液,在第一水性溶液中分散ORC颗粒,提供其中具有ORC颗粒的第一层的模具,将第一水性溶液倒入模具中,喷涂或注入氯化钙以接触第一水性溶液,从而引发藻酸钠的交联,冷冻干燥第一水性溶液以形成包括具有嵌入其中的ORC颗粒的水凝胶的第二层,在水中溶解藻酸钠以形成第二水性溶液,将第二水性溶液倒入模具中,喷涂或注入氯化钙以接触第二水性溶液,从而引发藻酸钠的交联,冷冻干燥第二水性溶液以形成包括水凝胶的第三层。Referring to FIG. 198B , a method of making a three-layer tissue thickness compensator can generally include dissolving a first hydrogel precursor in a first aqueous solution, dispersing biocompatible particles and/or fibers in the first aqueous solution, providing A mold 70260 having a first layer 70250 of biocompatible particles therein, providing a first aqueous solution into the mold, contacting the activating agent with the first aqueous solution, curing the first aqueous solution to form a second layer 70255, at The second hydrogel precursor is dissolved in the aqueous solution, the second aqueous solution is provided into the mold, and the second aqueous solution is cured to form the third layer 70265. A three-layer tissue thickness compensator can be fabricated by dissolving sodium alginate in water to form a first aqueous solution, dispersing ORC particles in the first aqueous solution, providing a mold with the first layer of ORC particles therein, placing the first The aqueous solution is poured into the mold, calcium chloride is sprayed or injected to contact the first aqueous solution, thereby initiating cross-linking of the sodium alginate, and the first aqueous solution is lyophilized to form a second aqueous gel comprising a hydrogel with ORC particles embedded therein. Two layers, dissolving sodium alginate in water to form a second aqueous solution, pouring the second aqueous solution into the mold, spraying or injecting calcium chloride to contact the second aqueous solution, thereby initiating cross-linking of the sodium alginate, freeze drying A second aqueous solution to form a third layer comprising a hydrogel.
根据本发明,制造包含至少一种储存和/或吸收于其中的药物的组织厚度补偿件的方法可大体包括提供组织厚度补偿件,以及使组织厚度补偿件和药物接触以将药物保留在组织厚度补偿件中。制造包含抗菌剂材料的组织厚度补偿件的方法可包括提供水凝胶,干燥水凝胶,在硝酸银水溶液中溶胀水凝胶,使水凝胶和氯化钠溶液接触,从而形成具有抗菌特性的组织厚度补偿件。组织厚度补偿件可包括分散在其中的银。According to the present invention, a method of making a tissue thickness compensator comprising at least one drug stored and/or absorbed therein may generally comprise providing the tissue thickness compensator, and contacting the tissue thickness compensator with the drug to retain the drug in the tissue thickness in compensation. A method of making a tissue thickness compensator comprising an antimicrobial material may comprise providing a hydrogel, drying the hydrogel, swelling the hydrogel in an aqueous solution of silver nitrate, contacting the hydrogel with a sodium chloride solution, thereby forming a tissue having antimicrobial properties. tissue thickness compensator. The tissue thickness compensator may include silver dispersed therein.
参见图204,制造组织厚度补偿件的方法可包括共挤出法和/或粘合法。例如,组织厚度补偿件70550可包括层合体,所述层合体包括第一层70555和以密封的方式包围包含水凝胶的内层70565的第二层70560。水凝胶可包括例如干膜、干泡沫、粉末和/或颗粒剂。水凝胶可包括超吸收性材料,例如聚乙烯吡咯烷酮、羧甲基纤维素、聚硫丙基丙烯酸酯。可通过将第一层和第二层的原材料分别从料斗给料于挤出机,然后提供第一层和第二层来顺序制造第一层和/或第二层。可将内层70565的原材料加入挤出机料斗。原材料可在升高的温度下在挤出机中分散混合和复合。随着原材料在开口处离开模具70570,内层70565可沉积到第一层70555的表面上。组织厚度补偿件可包括泡沫、膜、粉末和/或颗粒。第一层70555和第二层70560可以面对面定位。第二层70560可通过辊70575与第一层70555面对面对齐。第一层70555可附着到第二层70560,其中第一层70555和第二层70560可物理截留内层70565。层可以例如在光压、常规热轧粘合工艺和/或通过使用粘合剂接合在一起,以形成组织厚度补偿件70550。如图78所示,第一层70555和第二层70560可以通过例如利用槽轧辊70580的轧制过程接合在一起。任选地,作为以上所述的结果,可通过能共同形成外层或屏障的第一层70555和第二层70560容纳和/或密封内层70565。外层可阻止或减少内层70565接触水分,直至外层破裂。Referring to Fig. 204, methods of making a tissue thickness compensator may include coextrusion and/or bonding. For example, the tissue thickness compensator 70550 can comprise a laminate comprising a first layer 70555 and a second layer 70560 surrounding in a sealing manner an inner layer 70565 comprising a hydrogel. Hydrogels may include, for example, dry films, dry foams, powders and/or granules. Hydrogels may include superabsorbent materials such as polyvinylpyrrolidone, carboxymethylcellulose, polythiopropylacrylate. The first layer and/or the second layer may be manufactured sequentially by feeding raw materials for the first layer and the second layer from a hopper to the extruder, respectively, and then providing the first layer and the second layer. Raw materials for the inner layer 70565 can be fed into the extruder hopper. Raw materials can be dispersively mixed and compounded in an extruder at elevated temperatures. An inner layer 70565 may be deposited onto the surface of the first layer 70555 as the raw material exits the mold 70570 at the opening. Tissue thickness compensators may include foams, films, powders and/or granules. The first layer 70555 and the second layer 70560 can be positioned face-to-face. The second layer 70560 can be aligned face-to-face with the first layer 70555 by rollers 70575 . The first layer 70555 can be attached to the second layer 70560, wherein the first layer 70555 and the second layer 70560 can physically trap the inner layer 70565. The layers can be bonded together to form the tissue thickness compensator 70550, eg, in photopressing, a conventional calender bonding process, and/or through the use of adhesives. As shown in FIG. 78 , the first layer 70555 and the second layer 70560 may be joined together by a rolling process, for example, using grooved rolls 70580 . Optionally, as a result of the above, the inner layer 70565 can be contained and/or sealed by the first layer 70555 and the second layer 70560, which together can form an outer layer or barrier. The outer layer blocks or reduces the inner layer 70565's exposure to moisture until the outer layer ruptures.
参见图61,外科器械10的端部执行器12(图1)能够接收紧固件仓组件,诸如钉仓20000。如图61所示,钉仓20000能够配合在端部执行器12的钳口20070的钉仓通道20072中。作为另外一种选择,钉仓20000可与端部执行器12成一整体,使得钉仓20000和端部执行器12形成为单个单元构造。钉仓20000可包括例如第一主体部分,诸如刚性支撑部分20010。钉仓20000还可包括例如第二主体部分,诸如可压缩部分或组织厚度补偿件20020。作为另外一种选择,组织厚度补偿件20020可不包括钉仓20000的整体部分,但可相对于端部执行器12以其他方式定位。例如,组织厚度补偿件20020可被固定到端部执行器12的砧座20060或可以其他方式保持在端部执行器12中。参见图78,钉仓还可包括保持器夹具20126,其能够抑制组织厚度补偿件20020过早地从支撑部分20010分离。读者将会知道,本文所述的组织厚度补偿件可安装在多种端部执行器中或以其他的方式与多种端部执行器接合,并且这些在本发明的范围内。Referring to FIG. 61 , end effector 12 ( FIG. 1 ) of surgical instrument 10 is capable of receiving a fastener cartridge assembly, such as staple cartridge 20000 . As shown in FIG. 61 , the staple cartridge 20000 is configured to fit within the staple cartridge channel 20072 of the jaw 20070 of the end effector 12 . Alternatively, staple cartridge 20000 may be integral with end effector 12 such that staple cartridge 20000 and end effector 12 are formed as a single unit configuration. Staple cartridge 20000 can include a first body portion, such as rigid support portion 20010, for example. The staple cartridge 20000 can also include a second body portion, such as a compressible portion or tissue thickness compensator 20020, for example. Alternatively, tissue thickness compensator 20020 may not comprise an integral part of staple cartridge 20000 , but may be otherwise positioned relative to end effector 12 . For example, tissue thickness compensator 20020 may be secured to anvil 20060 of end effector 12 or may be otherwise retained within end effector 12 . Referring to FIG. 78 , the staple cartridge can also include a retainer clip 20126 that can inhibit premature separation of the tissue thickness compensator 20020 from the support portion 20010 . The reader will appreciate that the tissue thickness compensators described herein may be mounted in or otherwise engaged with a variety of end effectors and that such are within the scope of the present invention.
类似于本文所述的组织厚度补偿件,现在参见图78,组织厚度补偿件20020可从外科端部执行器12释放或与其脱离。例如,钉仓20000的刚性支撑部分20010可保持与端部执行器钳口20070的紧固件仓通道20072接合,而组织厚度补偿件20020从刚性支撑部分20010中脱离。在将钉20030(图78-图83)从刚性支撑部分2010中的钉腔20012部署后,组织厚度补偿件20020可从端部执行器12释放。钉20030可从钉腔20012击发,使得钉20030接合组织厚度补偿件20020。另外,一般参见图63、图82和图83,钉20030可捕获组织厚度补偿件20020的一部分连同缝合的组织T。组织厚度补偿件20020可为可变形的,并且捕获在击发钉20030内的组织厚度补偿件20020的部分可被压缩。类似于本文所述的组织厚度补偿件,组织厚度补偿件20020可补偿不同厚度、压缩性和/或密度的捕获于每个钉20030内的组织T。此外,也如本文所述,组织厚度补偿件20020可补偿变形钉20030产生的间隙。Similar to the tissue thickness compensators described herein, referring now to FIG. 78 , the tissue thickness compensator 20020 is releasable or detachable from the surgical end effector 12 . For example, the rigid support portion 20010 of the staple cartridge 20000 can remain engaged with the fastener cartridge channel 20072 of the end effector jaw 20070 while the tissue thickness compensator 20020 is disengaged from the rigid support portion 20010 . After staples 20030 ( FIGS. 78-83 ) are deployed from staple cavities 20012 in rigid support portion 2010 , tissue thickness compensator 20020 can be released from end effector 12 . Staples 20030 can be fired from staple cavities 20012 such that staples 20030 engage tissue thickness compensator 20020 . Additionally, referring generally to FIGS. 63 , 82 , and 83 , the staples 20030 can capture a portion of the tissue thickness compensator 20020 along with the stapled tissue T. The tissue thickness compensator 20020 can be deformable, and the portion of the tissue thickness compensator 20020 captured within the fired staples 20030 can be compressed. Similar to the tissue thickness compensators described herein, the tissue thickness compensator 20020 can compensate for tissue T captured within each staple 20030 of varying thickness, compressibility, and/or density. Additionally, tissue thickness compensator 20020 can compensate for gaps created by deformable staples 20030, also as described herein.
组织厚度补偿件20020可在未压缩高度和压缩高度之间压缩。参见图78,组织厚度补偿件20020可具有顶部表面20021和底部表面20022。组织厚度补偿件的高度可以是顶部表面20021和底部表面20022之间的距离。当向组织厚度补偿件20020施加最小力或不施加力时,即当组织厚度补偿件20020没有被压缩时,组织厚度补偿件20020的未压缩高度可以是顶部表面20021和底部表面20022之间的距离。例如当向组织厚度补偿件20020施加力,诸如当击发钉20030捕获组织厚度补偿件20020的一部分时,组织厚度补偿件20020的压缩高度可以是顶部表面20021和底部表面20022之间的距离。组织厚度补偿件20020可具有远侧末端20025和近侧末端20026。如图78所示,组织厚度补偿件20020的未压缩高度可在组织厚度补偿件20020的远侧末端20025和近侧末端20026之间为均一的。作为另外一种选择,未压缩高度可在远侧末端20025和近侧末端20026之间变化。例如,组织厚度补偿件20020的顶部表面20021和/或底部表面20022相对于其他部分可成角和/或阶梯式,使得未压缩高度在近侧末端20026和远侧末端20025之间变化。组织厚度补偿件20020的未压缩高度可例如为约0.08英寸。作为另外一种选择,组织厚度补偿件20020的未压缩高度可例如在约0.025英寸和约0.10英寸之间变化。The tissue thickness compensator 20020 is compressible between an uncompressed height and a compressed height. Referring to FIG. 78 , a tissue thickness compensator 20020 can have a top surface 20021 and a bottom surface 20022 . The height of the tissue thickness compensator can be the distance between the top surface 20021 and the bottom surface 20022. The uncompressed height of the tissue thickness compensator 20020 may be the distance between the top surface 20021 and the bottom surface 20022 when minimal or no force is applied to the tissue thickness compensator 20020, i.e., when the tissue thickness compensator 20020 is not compressed . For example, the compressed height of the tissue thickness compensator 20020 can be the distance between the top surface 20021 and the bottom surface 20022 when a force is applied to the tissue thickness compensator 20020, such as when the staples 20030 are fired to capture a portion of the tissue thickness compensator 20020. The tissue thickness compensator 20020 can have a distal end 20025 and a proximal end 20026 . As shown in FIG. 78 , the uncompressed height of the tissue thickness compensator 20020 can be uniform between the distal end 20025 and the proximal end 20026 of the tissue thickness compensator 20020 . Alternatively, the uncompressed height may vary between the distal tip 20025 and the proximal tip 20026. For example, the top surface 20021 and/or the bottom surface 20022 of the tissue thickness compensator 20020 can be angled and/or stepped relative to other portions such that the uncompressed height varies between the proximal end 20026 and the distal end 20025. The uncompressed height of the tissue thickness compensator 20020 can be, for example, about 0.08 inches. Alternatively, the uncompressed height of the tissue thickness compensator 20020 can vary, for example, between about 0.025 inches and about 0.10 inches.
如本文更详细的描述,组织厚度补偿件20020可在其近侧末端20026和远侧末端20025之间压缩至不同的压缩高度。作为另外一种选择,组织厚度补偿件20020可在其整个长度下均匀地压缩。组织厚度补偿件20020的压缩高度可取决于例如端部执行器12的几何形状、组织厚度补偿件20020的特性、接合的组织T和/或钉20030。组织厚度补偿件20020的压缩高度可与端部执行器12中的组织间隙有关。任选地,例如,当砧座20060朝钉仓20000夹紧时,组织间隙可被限定在钉仓20000的顶部平台表面20011(图78)和砧座20060的组织接触表面20061(图61)之间。组织间隙可例如为约0.025英寸或为约0.100英寸。组织间隙可例如为约0.750毫米或为约3.500毫米。组织厚度补偿件20020的压缩高度可例如等于或基本上等于组织间隙。当组织T定位在端部执行器12的组织间隙内时,组织厚度补偿件的压缩高度可减少,以便适应组织T。例如当组织间隙为约0.750毫米时,组织厚度补偿件的压缩高度可为约0.500毫米。例如,当组织间隙为约3.500毫米时,组织厚度补偿件20020的压缩高度可为约2.5mm。此外,组织厚度补偿件20020可包括最小压缩高度。例如,组织厚度补偿件20020的最小压缩高度可为约0.250毫米。限定在钉仓的平台表面和砧座的组织接触表面之间的组织间隙可例如等于或至少基本等于组织厚度补偿件的未压缩高度。As described in greater detail herein, the tissue thickness compensator 20020 is compressible between its proximal end 20026 and distal end 20025 to different compression heights. Alternatively, the tissue thickness compensator 20020 can be compressed uniformly throughout its length. The compressed height of the tissue thickness compensator 20020 may depend on, for example, the geometry of the end effector 12, the characteristics of the tissue thickness compensator 20020, the engaged tissue T, and/or the staples 20030. The compressed height of the tissue thickness compensator 20020 can be related to the tissue gap in the end effector 12 . Optionally, for example, when the anvil 20060 is clamped toward the staple cartridge 20000, a tissue gap can be defined between the top deck surface 20011 of the staple cartridge 20000 (FIG. 78) and the tissue contacting surface 20061 of the anvil 20060 (FIG. 61 ). between. The tissue gap can be, for example, about 0.025 inches or about 0.100 inches. The tissue gap can be, for example, about 0.750 millimeters or about 3.500 millimeters. The compressed height of the tissue thickness compensator 20020 can be, for example, equal or substantially equal to the tissue gap. As tissue T is positioned within the tissue gap of end effector 12, the compressed height of the tissue thickness compensator may decrease to accommodate tissue T. For example, when the tissue gap is about 0.750 mm, the compressed height of the tissue thickness compensator may be about 0.500 mm. For example, when the tissue gap is about 3.500 mm, the compressed height of the tissue thickness compensator 20020 can be about 2.5 mm. Additionally, the tissue thickness compensator 20020 can comprise a minimum compressed height. For example, the minimum compressed height of the tissue thickness compensator 20020 can be about 0.250 mm. The tissue gap defined between the deck surface of the staple cartridge and the tissue-contacting surface of the anvil can, for example, be equal to, or at least substantially equal to, the uncompressed height of the tissue thickness compensator.
主要参见图62,组织厚度补偿件20020可包括包含纤维20082的纤维非织造材料20080。组织厚度补偿件20020可包括毡或类似毡的材料。非织造材料20080中的纤维20082可通过本领域中已知的任何方法紧固在一起,包括但不限于针刺法、热粘合、水缠结、超声图案粘合、化学粘合和熔喷粘合。此外,非织造材料20080的层可通过机械、加热或化学方法紧固在一起以形成组织厚度补偿件20020。如本文更详细的描述,纤维的非织造材料20080可以是可压缩的,其可使组织厚度补偿件20020可压缩。组织厚度补偿件20020也可包括未压缩部分。例如,组织厚度补偿件20020可包括可压缩的非织造材料20080和未压缩部分。Referring primarily to FIG. 62 , the tissue thickness compensator 20020 can comprise a fibrous nonwoven material 20080 comprising fibers 20082 . Tissue thickness compensator 20020 may comprise felt or a felt-like material. The fibers 20082 in the nonwoven 20080 can be secured together by any method known in the art, including but not limited to needling, thermal bonding, hydroentanglement, ultrasonic pattern bonding, chemical bonding, and meltblowing bonding. Additionally, the layers of nonwoven material 20080 can be fastened together mechanically, thermally, or chemically to form tissue thickness compensator 20020 . As described in greater detail herein, the fibrous nonwoven material 20080 can be compressible, which can render the tissue thickness compensator 20020 compressible. The tissue thickness compensator 20020 can also include an uncompressed portion. For example, the tissue thickness compensator 20020 can comprise a compressible nonwoven material 20080 and an uncompressed portion.
仍主要参见图62,非织造材料20080可包括多个纤维20082。非织造材料20080中的至少一些纤维20082可以是卷曲纤维20086。卷曲纤维20086在非织造材料20080内可为例如卷曲的、扭曲的、盘绕的、弯曲的、变形的、螺旋形的、环绕的和/或弓形的。如本文更详细的描述,卷曲纤维20086可由任何合适的形状形成,使得卷曲纤维20086的变形产生弹簧负载力或恢复力。卷曲纤维20086可通过热成型以形成盘绕或基本上线圈状的形状。卷曲纤维20086可由非卷曲纤维20084形成。例如,非卷曲纤维20084可缠绕在受热的芯轴周围以形成基本上线圈状的形状。Still referring primarily to FIG. 62 , the nonwoven material 20080 can include a plurality of fibers 20082 . At least some of the fibers 20082 in the nonwoven 20080 can be crimped fibers 20086. The crimped fibers 20086 may be, for example, crimped, twisted, coiled, curved, deformed, helical, looped, and/or arcuate within the nonwoven material 20080. As described in greater detail herein, the crimped fibers 20086 may be formed from any suitable shape such that deformation of the crimped fibers 20086 produces a spring-loaded or restoring force. The crimped fibers 20086 can be thermoformed to form a coiled or substantially coiled shape. The crimped fibers 20086 can be formed from uncrimped fibers 20084. For example, non-crimped fibers 20084 can be wrapped around a heated mandrel to form a substantially coil-like shape.
组织厚度补偿件20020可包括均一化可吸收的聚合物基体。均一化可吸收的聚合物基体可包括例如泡沫、凝胶和/或膜。此外,多个纤维20082可分散于整个均一化可吸收的聚合物基体中。均一化可吸收的聚合物基体中的至少一些纤维20082可以是例如卷曲纤维20086。如本文更详细地描述,组织厚度补偿件2002的均一化可吸收的聚合物基体可以是可压缩的。The tissue thickness compensator 20020 can comprise a uniform absorbable polymer matrix. Uniform absorbable polymer matrices may include, for example, foams, gels and/or films. Additionally, a plurality of fibers 20082 can be dispersed throughout the uniform absorbable polymer matrix. At least some of the fibers 20082 in the uniform absorbable polymer matrix can be crimped fibers 20086, for example. As described in greater detail herein, the uniform absorbable polymer matrix of tissue thickness compensator 2002 may be compressible.
参见图65和图66,卷曲纤维20086可无规分散于整个非织造材料20080的至少一部分中。例如,卷曲纤维20086可无规分散于整个非织造材料20080中,使得非织造材料20080的一部分比非织造材料20080的其他部分包括更多卷曲纤维20086。此外,卷曲纤维20086可聚集在非织造材料20080中的例如纤维集群20085a、20085b、20085c、20085d和20085e中。卷曲纤维20086的形状可在非织造材料20080的制造期间引起纤维20086的缠结;卷曲纤维20086的缠结继而可引起纤维集群20085a、20085b、20085c、20085d和20085e的形成。除此之外或作为另外一种选择,卷曲纤维20086可在整个非织造材料20080中无规取向。例如,参见图62,第一卷曲纤维20086a可沿第一方向取向,第二卷曲纤维20086b可沿第二方向取向,并且第三卷曲纤维20086c可沿第三方向取向。Referring to FIGS. 65 and 66 , the crimped fibers 20086 can be randomly dispersed throughout at least a portion of the nonwoven material 20080 . For example, the crimped fibers 20086 can be randomly dispersed throughout the nonwoven material 20080 such that a portion of the nonwoven material 20080 includes more crimped fibers 20086 than other portions of the nonwoven material 20080. Additionally, the crimped fibers 20086 can be gathered in the nonwoven material 20080 in, for example, fiber clusters 20085a, 20085b, 20085c, 20085d, and 20085e. The shape of the crimped fibers 20086 can cause entanglement of the fibers 20086 during manufacture of the nonwoven material 20080; entanglement of the crimped fibers 20086 can in turn cause the formation of fiber clusters 20085a, 20085b, 20085c, 20085d, and 20085e. Additionally or alternatively, the crimped fibers 20086 can be randomly oriented throughout the nonwoven 20080. For example, referring to FIG. 62, first crimped fibers 20086a can be oriented in a first direction, second crimped fibers 20086b can be oriented in a second direction, and third crimped fibers 20086c can be oriented in a third direction.
卷曲纤维20086可系统地分布和/或布置于整个非织造材料20080的至少一部分。例如,现在参见图67,卷曲纤维20186可被定位在构造20185中,其中多个卷曲纤维20186a沿第一方向布置,而另外的多个卷曲纤维20186b沿第二方向布置。卷曲纤维20186可以重叠,使得他们相互缠结或互连。卷曲纤维20186可系统性布置,使得卷曲纤维20186a基本上平行于另一个卷曲纤维20186a。另一个卷曲纤维20186b可基本上横向于一些卷曲纤维20186a。任选地,卷曲纤维20186a可基本上与第一轴线Y对齐,并且卷曲纤维20186b可基本上与第二轴线X对齐。例如,第一轴线Y可垂直或基本上垂直于第二轴线X。The crimped fibers 20086 can be systematically distributed and/or arranged throughout at least a portion of the nonwoven material 20080. For example, referring now to FIG. 67, the crimped fibers 20186 can be positioned in a configuration 20185 with a plurality of crimped fibers 20186a arranged in a first direction and an additional plurality of crimped fibers 20186b arranged in a second direction. The crimped fibers 20186 can overlap such that they intertwine or interconnect. The crimped fibers 20186 can be arranged systematically such that one crimped fiber 20186a is substantially parallel to another crimped fiber 20186a. Another crimped fiber 20186b can be substantially transverse to some of the crimped fibers 20186a. Optionally, the crimped fibers 20186a can be substantially aligned with the first axis Y, and the crimped fibers 20186b can be substantially aligned with the second axis X. For example, the first axis Y may be perpendicular or substantially perpendicular to the second axis X.
主要参见图68,卷曲纤维20286可可被布置成构造20285。每个卷曲纤维20286可包括限定在卷曲纤维20286的第一末端20287和第二末端20289之间的纵向轴线。卷曲纤维20286可系统地分布在非织造材料20080中,使得一个卷曲纤维20286的第一末端20287定位在相邻于另一个卷曲纤维20286的第二末端20289的位置。作为另外一种选择,现在参见图69,纤维构造20385可包括例如沿第一方向取向的第一卷曲纤维20386a,沿第二方向取向的第二卷曲纤维20386b,以及沿第三方向取向的第三卷曲纤维20386c。根据本发明,卷曲纤维20286的单个图案或构造可在整个非织造材料20080中重复。卷曲纤维可在整个非织造材料20080中以不同图案布置。作为另外的另选形式,非织造材料20080可包括至少一个卷曲纤维图案,以及多个无规取向和/或无规分布的卷曲纤维。Referring primarily to FIG. 68 , crimped fibers 20286 may be arranged in configuration 20285 . Each crimped fiber 20286 can include a longitudinal axis defined between a first end 20287 and a second end 20289 of the crimped fiber 20286 . The crimped fibers 20286 can be distributed systematically in the nonwoven material 20080 such that a first end 20287 of one crimped fiber 20286 is positioned adjacent to a second end 20289 of another crimped fiber 20286 . Alternatively, referring now to FIG. 69, the fibrous construct 20385 can include, for example, first crimped fibers 20386a oriented in a first direction, second crimped fibers 20386b oriented in a second direction, and third crimped fibers 20386b oriented in a third direction. Curly Fiber 20386c. A single pattern or configuration of crimped fibers 20286 can be repeated throughout the nonwoven material 20080 in accordance with the present invention. The crimped fibers can be arranged in different patterns throughout the nonwoven 20080. As a further alternative, the nonwoven material 20080 can include at least one pattern of crimped fibers, and a plurality of randomly oriented and/or randomly distributed crimped fibers.
再次参见图62,非织造材料20080中的多个纤维20082可包括至少一些非卷曲纤维20084。非织造材料20080中的非卷曲纤维20084和卷曲纤维20086可缠结或互连。卷曲纤维20086与非卷曲纤维20084的比率可例如为约25:1。作为另外一种选择,卷曲纤维20086与非卷曲纤维20084的比率可例如为约1:25。作为另外一种选择,卷曲纤维20086与非卷曲纤维20084的比率可例如为约1:1。如本文更详细地描述,当非织造材料20080已变形,非织造材料20080的每单位体积中卷曲纤维20086的数量可影响非织造材料20080产生的恢复力。如本文同样更详细地描述,非织造材料20080产生的恢复力还可取决于例如非织造材料20080中卷曲纤维20086和非卷曲纤维20084的材料、形状、大小、位置和/或取向。Referring again to FIG. 62 , the plurality of fibers 20082 in the nonwoven material 20080 can include at least some uncrimped fibers 20084 . The uncrimped fibers 20084 and crimped fibers 20086 in the nonwoven material 20080 can be entangled or interconnected. The ratio of crimped fibers 20086 to non-crimped fibers 20084 can be, for example, about 25:1. Alternatively, the ratio of crimped fibers 20086 to non-crimped fibers 20084 may be, for example, about 1:25. Alternatively, the ratio of crimped fibers 20086 to non-crimped fibers 20084 may be, for example, about 1:1. As described in greater detail herein, the number of crimped fibers 20086 per unit volume of the nonwoven material 20080 can affect the restoring force that the nonwoven material 20080 produces when the nonwoven material 20080 has been deformed. As also described in greater detail herein, the restorative force produced by the nonwoven material 20080 can also depend on, for example, the material, shape, size, location and/or orientation of the crimped fibers 20086 and uncrimped fibers 20084 in the nonwoven material 20080.
非织造材料20080的纤维20082可包含聚合物组合物。纤维20082的聚合物组合物可包含不可吸收的聚合物、可吸收的聚合物或它们的组合。可吸收的聚合物可包括可生物吸收的、生物相容性弹性体聚合物。此外,纤维20082的聚合物组合物可包括合成聚合物、非合成聚合物或它们的组合。合成聚合物的示例包括但不限于聚乙醇酸(PGA)、聚(乳酸)(PLA)、聚己内酯(PCL)、聚二氧杂环己酮(PDO)和它们的共聚物。例如,纤维20082可包括90/10聚(乙交酯-L-丙交酯)共聚物,例如该共聚物可以商标名称VICRYL(polyglactic 910)从Ethicon,Inc.商购获得。非合成聚合物的示例包括但不限于冻干多聚糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和氧化再生纤维素(ORC)。任选地,类似于本文所述的组织厚度补偿件中的聚合物组合物,纤维20082的聚合物组合物可包括量不同(例如按重量百分比计)的可吸收的聚合物、不可吸收的聚合物、合成聚合物和/或非合成聚合物。The fibers 20082 of the nonwoven 20080 can comprise a polymer composition. The polymer composition of fibers 20082 may comprise non-absorbable polymers, absorbable polymers, or combinations thereof. Absorbable polymers can include bioabsorbable, biocompatible elastomeric polymers. Additionally, the polymer composition of fibers 20082 can include synthetic polymers, non-synthetic polymers, or combinations thereof. Examples of synthetic polymers include, but are not limited to, polyglycolic acid (PGA), poly(lactic acid) (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. For example, fiber 20082 can comprise a 90/10 poly(glycolide-L-lactide) copolymer, such as is commercially available from Ethicon, Inc. under the trade designation VICRYL (polyglactic 910). Examples of non-synthetic polymers include, but are not limited to, lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and oxidized regenerated cellulose (ORC). Optionally, the polymer composition of the fibers 20082 can include absorbable polymers, nonabsorbable polymers, substances, synthetic polymers and/or non-synthetic polymers.
非织造材料20080的卷曲纤维20086可包括第一聚合物组合物,而非织造材料20080的非卷曲纤维20084可包括不同的聚合物组合物。例如,卷曲纤维20086可包括合成聚合物,诸如90/10聚(乙交酯-L-丙交酯),而非卷曲纤维20084可包括非合成聚合物,诸如氧化再生纤维素。作为另外一种选择,卷曲纤维20086和非卷曲纤维20084可包括相同的聚合物组合物。The crimped fibers 20086 of the nonwoven material 20080 can comprise a first polymer composition, while the uncrimped fibers 20084 of the nonwoven material 20080 can comprise a different polymer composition. For example, crimped fibers 20086 may comprise a synthetic polymer, such as 90/10 poly(glycolide-L-lactide), while uncrimped fibers 20084 may comprise a non-synthetic polymer, such as oxidized regenerated cellulose. Alternatively, the crimped fibers 20086 and the uncrimped fibers 20084 can comprise the same polymer composition.
如本文所述,卷曲纤维20086和非卷曲纤维20084可以通过例如针刺法、热粘合、水缠结、超声图案粘合、化学粘合和熔喷粘合紧固在一起。包括合成纤维例如“VICRYL(polyglactic 910)”的卷曲纤维20086,以及包括氧化再生纤维素的非卷曲纤维20084可通过针刺在一起形成非织造材料20080。非织造材料20080可包括例如为约5%至50%(按重量计)的卷曲“VICRYL(polyglactic 910)”纤维20086,以及为约5%至50%(按重量计)的非卷曲氧化再生纤维素(ORC)纤维20084。例如当非织造材料20080接触组织T时,非卷曲ORC纤维20084可迅速与组织中的血浆反应以形成凝胶状块。凝胶状ORC块的形成可瞬时或几乎瞬时地与组织接触。此外,在凝胶状ORC块形成之后,卷曲的“VICRYL(polyglactic 910)”纤维20086可仍然分布于整个非织造材料20080。例如,卷曲纤维20086可悬浮在凝胶状ORC块中。由于凝胶状ORC块可生物吸收,卷曲“VICRYL(polyglactic910)”纤维20086可在邻近组织上施加回弹力,如本文更详细地描述。此外,组织可开始在“VICRYL(polyglactic 910)”纤维和/或成形钉30030的周围愈合,也如本文更详细地描述。As described herein, the crimped fibers 20086 and uncrimped fibers 20084 can be secured together by, for example, needling, thermal bonding, hydroentanglement, ultrasonic pattern bonding, chemical bonding, and melt blown bonding. The crimped fibers 20086 comprising synthetic fibers such as "VICRYL (polyglactic 910)" and the uncrimped fibers 20084 comprising oxidized regenerated cellulose can be needle punched together to form the nonwoven 20080. The nonwoven material 20080 can comprise, for example, about 5% to 50% (by weight) of crimped "VICRYL (polyglactic 910)" fibers 20086, and about 5% to 50% (by weight) of non-crimped oxidized regenerated fibers (ORC) Fiber 20084. For example, when the nonwoven material 20080 contacts tissue T, the non-crimped ORC fibers 20084 can quickly react with blood plasma in the tissue to form a gel-like mass. The formation of gelatinous ORC masses can be in contact with tissue instantaneously or nearly instantaneously. Additionally, the crimped "VICRYL (polyglactic 910)" fibers 20086 may remain distributed throughout the nonwoven 20080 after the gelatinous ORC mass is formed. For example, crimped fibers 20086 can be suspended in a gelatinous ORC mass. Since the gelatinous ORC mass is bioabsorbable, the coiled "VICRYL (polyglactic 910)" fibers 20086 can exert a resilient force on adjacent tissue, as described in more detail herein. In addition, tissue can begin to heal around the "VICRYL (polyglactic 910)" fibers and/or formed staples 30030, also as described in greater detail herein.
主要参见图78-图81,钉仓20000的支撑部分20010可包括仓体20017、顶部平台表面20011和多个钉腔20012。每个钉腔20012可限定平台表面20011中的开口。钉20030可被可移除地定位在钉腔20012中。根据本发明,单个钉20030设置在每个钉腔20012内。主要参见图82和图83,并且类似于本文所述的钉,每个钉20030可包括具有第一末端20035和第二末端20036的基部20031。钉腿20032可从基部20031的第一末端20035延伸,而另一个钉腿20032可从基部20031的第二末端20036延伸。再次参见图78-图81,在部署钉20030之前,每个钉20030的基部20031可由钉驱动器20040支撑,该钉驱动器定位在钉仓20000的刚性支撑部分20010内。另外,在部署钉20030之前,每个钉20030的腿20032可至少部分地包含在钉腔20012内。Referring primarily to FIGS. 78-81 , the support portion 20010 of the staple cartridge 20000 can include a cartridge body 20017 , a top deck surface 20011 and a plurality of staple cavities 20012 . Each staple cavity 20012 can define an opening in the deck surface 20011. Staples 20030 can be removably positioned within staple cavities 20012 . A single staple 20030 is disposed within each staple cavity 20012 in accordance with the present invention. Referring primarily to FIGS. 82 and 83 , and similar to the staples described herein, each staple 20030 can include a base 20031 having a first end 20035 and a second end 20036 . A staple leg 20032 can extend from a first end 20035 of the base 20031 , while another staple leg 20032 can extend from a second end 20036 of the base 20031 . Referring again to FIGS. 78-81 , prior to deployment of the staples 20030 , the base 20031 of each staple 20030 can be supported by a staple driver 20040 positioned within the rigid support portion 20010 of the staple cartridge 20000 . Additionally, the legs 20032 of each staple 20030 can be at least partially contained within the staple cavity 20012 prior to deployment of the staples 20030 .
钉20030可被部署在初始位置与击发位置之间。例如,主要参见图81,钉20030可处于初始位置(钉20030e、20030f)、部分击发或中间位置(钉20030c、20030d)或击发位置(钉20030a、20030b)。驱动器20040可以驱动处于初始位置和击发位置之间的钉。例如,每个钉20030的基部20031可由驱动器20040支持。钉(例如图80中的钉20030e、20030f)的腿20032可被定位在钉腔20012内。当击发构件或钉击发滑动件20050从钉仓20000的近侧末端20001向远侧末端20002平移时,滑动件20050上的倾斜表面20051可接触驱动器20040上的倾斜表面20042,以部署定位在所接触驱动器20040之上的钉20030。钉20030可被部署在初始位置和击发位置之间,使得腿20032运动穿过组织厚度补偿件20020的非织造材料20080,穿透组织厚度补偿件20020的顶部表面20021,穿透组织T,以及接触定位在端部执行器12中钉腔20000对面的砧座20060(图61)。钉腿20032可针对于砧座20060变形,每个钉20030的腿20032可捕获非织造材料20080的一部分和组织T的一部分。The staples 20030 can be deployed between an initial position and a fired position. For example, referring primarily to FIG. 81 , staples 20030 can be in an initial position (staples 20030e, 20030f), a partially fired or intermediate position (staples 20030c, 20030d) or a fired position (staples 20030a, 20030b). The driver 20040 can drive the staples between the initial position and the fired position. For example, the base 20031 of each staple 20030 can be supported by a driver 20040 . Legs 20032 of staples (eg, staples 20030e, 20030f in FIG. 80 ) can be positioned within staple cavities 20012 . As the firing member or staple firing sled 20050 translates from the proximal end 20001 to the distal end 20002 of the staple cartridge 20000, the ramped surface 20051 on the sled 20050 can contact the ramped surface 20042 on the driver 20040 to deploy positioned on the contacted Nail 20030 over driver 20040. The staples 20030 can be deployed between the initial position and the fired position such that the legs 20032 move through the nonwoven material 20080 of the tissue thickness compensator 20020, penetrate the top surface 20021 of the tissue thickness compensator 20020, penetrate the tissue T, and contact Anvil 20060 is positioned opposite staple cavity 20000 in end effector 12 (FIG. 61). Staple legs 20032 are deformable against anvil 20060 and legs 20032 of each staple 20030 can capture a portion of nonwoven material 20080 and a portion of tissue T.
在击发构型(图82和图83)中,每个钉20030可向组织T和捕获在钉20030内的组织厚度补偿件20020施加压缩力。主要参见图80和图81,每个钉20030的腿20032可以朝钉20030的基部20031向下变形,以形成钉截留区域20039。钉截留区域20039可为组织T和组织厚度补偿件20020可被击发钉20030所捕获的区域。在各种情况下,钉截留区域20039可限定在已变形的腿20032的内表面和钉20030的基部20031的内表面之间。钉20030的截留区域20039的尺寸可取决于若干因素,例如腿的长度、腿的直径、基部的宽度和/或腿变形的程度。In the fired configuration ( FIGS. 82 and 83 ), each staple 20030 can apply a compressive force to the tissue T and the tissue thickness compensator 20020 captured within the staple 20030 . Referring primarily to FIGS. 80 and 81 , the legs 20032 of each staple 20030 can be deformed downward toward the base 20031 of the staple 20030 to form a staple entrapment region 20039 . The staple entrapment region 20039 can be the region where the tissue T and the tissue thickness compensator 20020 can be captured by the fired staples 20030 . In various circumstances, a staple entrapment region 20039 can be defined between the inner surface of the deformed leg 20032 and the inner surface of the base 20031 of the staple 20030 . The size of the entrapment area 20039 of the staple 20030 can depend on several factors, such as the length of the leg, the diameter of the leg, the width of the base, and/or the degree of deformation of the leg.
任选地,当非织造材料20080被捕获于钉截留区域20039时,非织造材料20080的被捕获部分可被压缩。捕获于钉截留区域20039内的非织造材料20080的压缩高度可根据相同钉截留区域20039内的组织T而在钉仓20000内变化。例如,在组织T较薄的情况下,钉截留区域20039可具有更多给予非织造材料20080的空间,因此,非织造材料20080被压缩的程度可能不像组织T较厚时其将被压缩的那样大。例如在组织T较厚的情况下,非织造材料20080可被压缩的更多,以适应较厚的组织T。例如,参见图82,非织造材料20080可例如在第一钉截留区域20039a内压缩至第一高度,在第二钉截留区域20039b内压缩至第二高度,在第三钉截留区域20039c内压缩至第三高度,在第四钉截留区域20039d内压缩至第四高度,并且在第五钉截留区域20039e内压缩至第五高度。相似地,如图83所示,非织造材料20080可在第一钉截留区域20039a内压缩至第一高度,在第二钉截留区域20039b内压缩至第二高度,在第三钉截留区域20039c内压缩至第三高度,并且在第四钉截留区域20039d内压缩至第四高度。作为另外一种选择,非织造材料20080的压缩高度可在整个钉仓20010内为均一的。Optionally, when the nonwoven material 20080 is captured in the staple entrapment region 20039, the captured portion of the nonwoven material 20080 can be compressed. The compressed height of the nonwoven material 20080 captured within the staple entrapment region 20039 can vary within the staple cartridge 20000 depending on the tissue T within the same staple entrapment region 20039 . For example, where the tissue T is thinner, the staple entrapment region 20039 may have more room to give the nonwoven 20080, and thus, the nonwoven 20080 may not be compressed as much as it would be if the tissue T were thicker. that big. For example, where the tissue T is thicker, the nonwoven material 20080 can be compressed more to accommodate the thicker tissue T. For example, referring to FIG. 82, the nonwoven material 20080 can be compressed to a first height within a first staple entrapment region 20039a, to a second height within a second staple entrapment region 20039b, and to a height within a third staple entrapment region 20039c, for example, with reference to FIG. A third height, compressed to a fourth height within the fourth staple entrapment region 20039d, and compressed to a fifth height within the fifth staple entrapment region 20039e. Similarly, as shown in FIG. 83, the nonwoven material 20080 can be compressed to a first height within a first staple entrapment region 20039a, to a second height within a second staple entrapment region 20039b, and to a second height within a third staple entrapment region 20039c. Compressed to a third height, and compressed to a fourth height within the fourth staple entrapment region 20039d. Alternatively, the compressed height of the nonwoven material 20080 can be uniform throughout the staple cartridge 20010.
任选地,所施加的力可将非织造材料20080从初始未压缩构型运动至压缩构型。此外,非织造材料20080可具有弹性,使得非织造材料20080被压缩时可产生回弹力或恢复力。变形时,该非织造材料20080可试图从压缩或变形的构型中回弹。当非织造材料20080试图回弹时,其可在也被捕获于钉截留区域30039内的组织上施加回弹力或恢复力,如本文更详细地描述。当施加的力被随后移除时,恢复力可使非织造材料从压缩的构型中回弹。非织造材料20080可回弹至初始未压缩构型或可回弹至基本上类似于初始未压缩构型的构型。非织造材料20080的变形可为弹性的。非织造材料的变形可为部分弹性和部分塑性的。Optionally, the applied force can move the nonwoven material 20080 from an initial uncompressed configuration to a compressed configuration. Additionally, the nonwoven material 20080 can be elastic such that the nonwoven material 20080 can generate a resilient or restoring force when compressed. When deformed, the nonwoven material 20080 can attempt to rebound from the compressed or deformed configuration. As the nonwoven material 20080 attempts to spring back, it can exert a resilient or restoring force on tissue that is also captured within the staple entrapment region 30039, as described in greater detail herein. The restoring force can cause the nonwoven to rebound from the compressed configuration when the applied force is subsequently removed. The nonwoven material 20080 can rebound to an original uncompressed configuration or can rebound to a configuration substantially similar to the original uncompressed configuration. The deformation of the nonwoven material 20080 can be elastic. The deformation of the nonwoven can be partially elastic and partially plastic.
当非织造材料20080的一部分被压缩在钉截留区域20039中时,非织造补偿件20039内的该部分中的卷曲纤维20086还可以压缩或以其他的方式变形。卷曲纤维20086的变形量可与非织造材料20080的被捕获部分的压缩量相对应。例如,参见图63,非织造材料20080可被部署的钉20030捕获。非织造材料20080被所部署的钉20030压缩得越多,卷曲纤维20086的平均变形就可越大。此外,非织造材料20080被所部署的钉压缩得越少,卷曲纤维20086的平均变形就可越小。相似地,参见图82和图83,在其中非织造材料20080被压缩越多的钉截留区域20039d中,钉截留区域20039d内的卷曲纤维20086可通常变形得越多。此外,在钉截留区域20039a内,非织造材料20080被压缩得越少,钉截留区域20039a内的卷曲纤维20086可通常变形得越少。When a portion of the nonwoven material 20080 is compressed in the staple entrapment region 20039, the crimped fibers 20086 in that portion within the nonwoven compensator 20039 may also compress or otherwise deform. The amount of deformation of the crimped fibers 20086 may correspond to the amount of compression of the captured portion of the nonwoven material 20080. For example, referring to FIG. 63 , nonwoven material 20080 can be captured by deployed staples 20030 . The more the nonwoven material 20080 is compressed by the deployed staples 20030, the greater the average deformation of the crimped fibers 20086 can be. Furthermore, the less the nonwoven material 20080 is compressed by the deployed staples, the less the average deformation of the crimped fibers 20086 can be. Similarly, referring to FIGS. 82 and 83 , in the staple entrapment region 20039d where the nonwoven material 20080 is more compressed, the crimped fibers 20086 within the staple entrapment region 20039d may generally be more deformed. Furthermore, the less the nonwoven material 20080 is compressed within the staple entrapment region 20039a, the less the crimped fibers 20086 within the staple entrapment region 20039a can generally deform.
非织造材料20080从变形的构型回弹的能力,即,非织造材料20080的回弹力,可取决于非织造材料20080内卷曲纤维20086的回弹力。卷曲纤维20086可有回弹力地变形。卷曲纤维20086的变形可为部分弹性和部分塑性的。任选地,每个卷曲纤维20086的压缩可使被压缩的卷曲纤维20086产生回弹力或恢复力。例如,当纤维20086试图从其压缩构型中回弹的时候,被压缩的卷曲纤维20086可产生恢复力。纤维20086可试图恢复到其初始未压缩构型或基本上类似于其构型的构型。卷曲纤维20086可试图部分恢复到其初始构型。任选地,非织造材料20080内卷曲纤维20086的仅一部分可具有弹性。当卷曲纤维20086包含线性弹性材料时,被压缩的卷曲纤维20086的恢复力可取决于例如卷曲纤维20086被压缩的数量和卷曲纤维20086的弹簧劲度系数。卷曲纤维20086的弹簧劲度系数可至少取决于例如卷曲纤维20086的取向、材料、形状和/或尺寸。The ability of the nonwoven 20080 to rebound from a deformed configuration, ie, the resilience of the nonwoven 20080 , may depend on the resilience of the crimped fibers 20086 within the nonwoven 20080 . The crimped fibers 20086 are resiliently deformable. The deformation of the crimped fibers 20086 can be partially elastic and partially plastic. Optionally, the compression of each crimped fiber 20086 can impart a resilient or restoring force to the compressed crimped fiber 20086. For example, the compressed crimped fibers 20086 can generate a restoring force when the fibers 20086 attempt to rebound from their compressed configuration. Fiber 20086 may attempt to return to its original uncompressed configuration or a configuration substantially similar to its configuration. The crimped fibers 20086 may attempt to partially return to their original configuration. Optionally, only a portion of the crimped fibers 20086 within the nonwoven 20080 may be elastic. When the crimped fibers 20086 comprise a linear elastic material, the restoring force of the compressed crimped fibers 20086 may depend on, for example, the amount the crimped fibers 20086 are compressed and the spring rate of the crimped fibers 20086. The spring rate of the crimped fibers 20086 can depend at least on the orientation, material, shape, and/or size of the crimped fibers 20086, for example.
非织造材料20080内的卷曲纤维20086可包括均一的弹簧劲度系数。作为另外一种选择,非织造材料20080内的卷曲纤维20086的弹簧劲度系数可以是变化的。当具有大弹簧劲度系数的卷曲纤维20086被极大地压缩时,卷曲纤维20086可产生大的恢复力。当具有同样大的弹簧劲度系数的卷曲纤维20086被压缩得较少时,卷曲纤维20086可产生更小的恢复力。由非织造材料20080内的压缩的卷曲纤维20086产生的恢复力的总和可产生在组织厚度补偿件20020的整个非织造材料20080上的合并恢复力。非织造材料20080可在被捕获在具有压缩的非织造材料20080的击发钉20030内的组织T上施加合并恢复力。The crimped fibers 20086 within the nonwoven material 20080 can include a uniform spring rate. Alternatively, the spring rate of the crimped fibers 20086 within the nonwoven material 20080 may vary. When the crimped fiber 20086 with a large spring rate is greatly compressed, the crimped fiber 20086 can generate a large restoring force. When the crimped fiber 20086 with the same large spring rate is compressed less, the crimped fiber 20086 can produce less restoring force. The sum of the restoring forces produced by the compressed crimped fibers 20086 within the nonwoven material 20080 can produce a combined restoring force across the entire nonwoven material 20080 of the tissue thickness compensator 20020 . The nonwoven material 20080 can exert a combined restorative force on the tissue T captured within the fired staples 20030 with the nonwoven material 20080 compressed.
此外,每单位体积非织造材料20080的卷曲纤维20086的数量可影响非织造材料20080的弹簧劲度系数。例如,当每单位体积非织造材料20080的卷曲纤维20086的数量较少时,非织造材料20080中的回弹力可较低;例如,当每单位体积非织造材料20080的卷曲纤维20086的数量较多时,非织造材料20080中的回弹力可较高;例如,当每单位体积非织造材料20080的卷曲纤维20086的数量更多时,非织造材料20080中的回弹力可更高。当非织造材料20080的回弹力较低时,例如当每单位体积非织造材料20080的卷曲纤维20086的数量较低时,由组织厚度补偿件20020施加在所捕获的组织T上的合并恢复力也可较小。当非织造材料20080的回弹力较高时,例如当每单位体积非织造材料20080的卷曲纤维20086的数量较高时,由组织厚度补偿件20020施加在所捕获的组织T上的恢复力总和也可较高。Additionally, the number of crimped fibers 20086 per unit volume of nonwoven material 20080 can affect the spring rate of nonwoven material 20080. For example, when the number of crimped fibers 20086 per unit volume of nonwoven material 20080 is low, the resiliency in nonwoven material 20080 can be lower; for example, when the number of crimped fibers 20086 per unit volume of nonwoven material 20080 is high , the resiliency in the nonwoven 20080 can be higher; for example, the resiliency in the nonwoven 20080 can be higher when the number of crimped fibers 20086 per unit volume of the nonwoven 20080 is greater. When the resiliency of the nonwoven material 20080 is low, for example, when the number of crimped fibers 20086 per unit volume of the nonwoven material 20080 is low, the combined restoring force exerted by the tissue thickness compensator 20020 on the captured tissue T may also be smaller. When the resilience of the nonwoven material 20080 is high, for example, when the number of crimped fibers 20086 per unit volume of the nonwoven material 20080 is high, the sum of the restoring forces exerted by the tissue thickness compensator 20020 on the captured tissue T also increases. Can be higher.
主要参见图64,组织厚度补偿件20020’的非织造材料20080’可包括治疗剂20088,诸如药物和/或药物活性剂。非织造材料20080’可释放治疗有效量的治疗剂20088。例如,当非织造材料20080’被吸收时,治疗剂20088可被释放。治疗剂20088可被释放到流经非织造材料20080’之上或穿过非织造材料20080’的流体,诸如血液。治疗剂20088的示例可包含但不限于止血剂和药物,诸如血纤维蛋白、凝血酶和/或氧化再生纤维素(ORC);抗炎药物,诸如双氯芬酸、阿司匹林、萘普生、舒林酸和/或氢化可的松;抗生素和抗微生物药物或制剂,诸如三氯生、离子银、氨苄青霉素、庆大霉素、多粘菌素B、和/或氯霉素;和/或抗癌剂,诸如顺铂、丝裂霉素和/或阿霉素。治疗剂20088可包含生物制剂,诸如干细胞。非织造材料20080’的纤维20082可包含治疗剂20088。作为另外一种选择,治疗剂20088可添加至非织造材料20080’或以其他的方式整合到组织厚度补偿件20020’内。Referring primarily to Fig. 64, the nonwoven material 20080' of the tissue thickness compensator 20020' can include a therapeutic agent 20088, such as a drug and/or a pharmaceutically active agent. The nonwoven material 20080' can release a therapeutically effective amount of a therapeutic agent 20088. For example, the therapeutic agent 20088 can be released when the nonwoven material 20080' is absorbed. The therapeutic agent 20088 may be released into a fluid, such as blood, flowing over or through the nonwoven material 20080'. Examples of therapeutic agents 20088 may include, but are not limited to, hemostatic agents and drugs such as fibrin, thrombin, and/or oxidized regenerated cellulose (ORC); anti-inflammatory drugs such as diclofenac, aspirin, naproxen, sulindac, and and/or hydrocortisone; antibiotic and antimicrobial drugs or agents such as triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, and/or chloramphenicol; and/or anticancer agents , such as cisplatin, mitomycin and/or doxorubicin. Therapeutics 20088 may comprise biological agents, such as stem cells. The fibers 20082 of the nonwoven 20080' can comprise a therapeutic agent 20088. Alternatively, the therapeutic agent 20088 may be added to the nonwoven material 20080' or otherwise incorporated into the tissue thickness compensator 20020'.
主要参见图70-图70B,用于端部执行器12(图61)的组织厚度补偿件20520可包括多个弹簧或盘绕纤维20586。与本文所述的卷曲纤维20086类似,盘绕纤维20586在组织厚度补偿件20520内可为(例如)卷曲的、扭曲的、盘绕的、弯曲的、变形的、螺旋形的、环绕的和/或弓形的。盘绕纤维20586可缠绕在芯轴周围以形成盘绕或基本上线圈状的形状。盘绕纤维20586可在整个组织厚度补偿件20520上无规取向和/或无规分布。作为另外一种选择,盘绕纤维20586可在整个组织厚度补偿件20520上系统性布置和/或不均一分布。例如,参见图70,盘绕纤维20586可包括盘绕纤维20586的第一末端20587与第二末端20589之间的纵向轴线。组织厚度补偿件20520中的盘绕纤维20520的纵向轴线可平行或基本上平行。每个盘绕纤维20520的第一末端20587可沿着组织厚度补偿件20520的第一纵向侧20523定位并且每个盘绕纤维20586的第二末端20589可沿着组织厚度补偿件20520的第二纵向侧20524定位。在此类构造中,盘绕纤维20586可侧向地横贯组织厚度补偿件。作为另外一种选择,盘绕纤维20586可纵向或对角地横贯组织厚度补偿件20520。Referring primarily to FIGS. 70-70B , the tissue thickness compensator 20520 for the end effector 12 ( FIG. 61 ) can include a plurality of springs or coiled fibers 20586 . Similar to the coiled fibers 20086 described herein, the coiled fibers 20586 can be, for example, coiled, twisted, coiled, curved, deformed, helical, looped, and/or arcuate within the tissue thickness compensator 20520 of. Coiled fibers 20586 may be wrapped around a mandrel to form a coiled or substantially coiled shape. The coiled fibers 20586 can be randomly oriented and/or randomly distributed throughout the tissue thickness compensator 20520 . Alternatively, coiled fibers 20586 may be systematically arranged and/or non-uniformly distributed throughout tissue thickness compensator 20520 . For example, referring to FIG. 70 , the coiled fibers 20586 can include a longitudinal axis between a first end 20587 and a second end 20589 of the coiled fibers 20586 . The longitudinal axes of the coiled fibers 20520 in the tissue thickness compensator 20520 can be parallel or substantially parallel. The first end 20587 of each coiled fiber 20520 can be positioned along the first longitudinal side 20523 of the tissue thickness compensator 20520 and the second end 20589 of each coiled fiber 20586 can be positioned along the second longitudinal side 20524 of the tissue thickness compensator 20520 position. In such configurations, the coiled fibers 20586 can laterally traverse the tissue thickness compensator. Alternatively, coiled fibers 20586 may traverse tissue thickness compensator 20520 longitudinally or diagonally.
任选地,与本文所述的卷曲纤维20086类似,盘绕纤维20586可包含聚合物组合物。卷曲纤维20586可至少部分地具有弹性,使得卷曲纤维20586的变形产生恢复力。盘绕纤维20586的聚合物组合物可包含例如聚己内酯(PCL),使得盘绕纤维20586在叶绿素溶剂中为不可溶的。参见图70A,弹簧或盘绕纤维20520可保持在补偿材料20580中。补偿材料20580可将盘绕纤维20586保持在加载位置,使得盘绕纤维20586对补偿材料20580施加弹簧负载在补偿材料20580内施加弹簧负载。补偿材料20580可将盘绕纤维20586保持在中立位置,在该情况下盘绕纤维20586不会对补偿材料20580施加弹簧负载或在补偿材料20580内施加弹簧负载。补偿材料20580可为可生物吸收的,并且在一些情况下,可包含泡沫,诸如聚乙醇酸(PGA)泡沫。此外,补偿材料20580在例如叶绿素溶剂中可为可溶的。组织厚度补偿件可包括例如含有聚己内酯(PCL)的盘绕纤维20586和含有聚乙醇酸(PGA)泡沫的补偿材料20580,使得盘绕纤维20520在叶绿素溶剂中为不可溶的,而补偿材料20580在叶绿素溶剂中为可溶的。补偿材料20580可至少部分地具有弹性,使得补偿材料20580的压缩产生恢复力。此外,参见图70B,组织厚度补偿件20520的补偿材料20580可包含治疗剂20588,诸如干细胞。当补偿材料20580被吸收时补偿材料20580可释放治疗有效量的治疗剂20588。Optionally, the coiled fibers 20586 can comprise a polymeric composition similar to the coiled fibers 20086 described herein. The crimped fibers 20586 can be at least partially elastic such that deformation of the crimped fibers 20586 produces a restoring force. The polymer composition of the coiled fibers 20586 may comprise, for example, polycaprolactone (PCL), such that the coiled fibers 20586 are insoluble in chlorophyll solvents. Referring to FIG. 70A , spring or coiled fibers 20520 may be retained in compensating material 20580 . The compensation material 20580 can hold the coiled fibers 20586 in a loaded position such that the coiled fibers 20586 apply a spring load to the compensation material 20580 and apply a spring load within the compensation material 20580 . The compensation material 20580 can hold the coiled fibers 20586 in a neutral position, where the coiled fibers 20586 do not apply a spring load to or within the compensation material 20580 . Compensation material 20580 may be bioabsorbable and, in some cases, may comprise foam, such as polyglycolic acid (PGA) foam. Additionally, compensation material 20580 may be soluble in, for example, a chlorophyll solvent. The tissue thickness compensator may comprise, for example, coiled fibers 20586 comprising polycaprolactone (PCL) and a compensating material 20580 comprising polyglycolic acid (PGA) foam such that the coiled fibers 20520 are insoluble in chlorophyll solvents while the compensating material 20580 It is soluble in chlorophyll solvent. The compensation material 20580 can be at least partially elastic such that compression of the compensation material 20580 produces a restoring force. In addition, referring to Fig. 70B, the compensation material 20580 of the tissue thickness compensator 20520 may comprise a therapeutic agent 20588, such as stem cells. The compensation material 20580 can release a therapeutically effective amount of the therapeutic agent 20588 when the compensation material 20580 is absorbed.
与本文所述的组织厚度补偿件20020类似,组织厚度补偿件20520可以是可压缩的。例如,当钉20030(图78-图81)被从初始位置部署到击发位置时,钉20030可接合组织厚度补偿件20520的一部分。根据本发明,钉20030可捕获组织厚度补偿件20520的一部分和相邻组织T。钉20030可向组织厚度补偿件20520的被捕获部分和组织T施加压缩力,使得组织厚度补偿件20520被从未压缩高度压缩至压缩高度。组织厚度补偿件20520的压缩可导致其中的盘绕纤维20586的对应变形。如本文更详细地描述,每个盘绕纤维20586的变形均可产生恢复力,该恢复力可取决于盘绕纤维的回弹力,例如,盘绕纤维20586的变形量和/或盘绕纤维20586的弹簧劲度系数。盘绕纤维20586的弹簧劲度系数可至少取决于例如盘绕纤维20586的取向、材料、形状和/或尺寸。组织厚度补偿件20520中盘绕纤维20586的变形可在整个组织厚度补偿件20520上产生恢复力。组织厚度补偿件20520可对击发钉20030中的被捕获组织T施加由变形的盘绕纤维20586和/或弹性补偿材料20586产生的恢复力总和。Similar to tissue thickness compensator 20020 described herein, tissue thickness compensator 20520 can be compressible. For example, the staples 20030 ( FIGS. 78-81 ) can engage a portion of the tissue thickness compensator 20520 when the staples 20030 ( FIGS. 78-81 ) are deployed from an initial position to a fired position. Staples 20030 can capture a portion of tissue thickness compensator 20520 and adjacent tissue T in accordance with the present invention. The staples 20030 can apply a compressive force to the captured portion of the tissue thickness compensator 20520 and the tissue T such that the tissue thickness compensator 20520 is compressed from an uncompressed height to a compressed height. Compression of the tissue thickness compensator 20520 can cause a corresponding deformation of the coiled fibers 20586 therein. As described in greater detail herein, deformation of each coiled fiber 20586 can produce a restoring force that can depend on the resiliency of the coiled fiber, for example, the amount of deformation of the coiled fiber 20586 and/or the spring rate of the coiled fiber 20586 coefficient. The spring rate of the coiled fibers 20586 can depend at least on the orientation, material, shape and/or size of the coiled fibers 20586, for example. Deformation of the coiled fibers 20586 in the tissue thickness compensator 20520 can generate a restoring force across the tissue thickness compensator 20520 . The tissue thickness compensator 20520 can apply the sum of the restoring forces produced by the deformed coiled fibers 20586 and/or the elastic compensating material 20586 to the captured tissue T in the fired staples 20030 .
主要参见图71和图72,用于端部执行器12的组织厚度补偿件20620可包括多个弹簧线圈20686。与本文所述的卷曲纤维20086和盘绕纤维20586类似,弹簧线圈20686在组织厚度补偿件20620内可为(例如)卷曲的、扭曲的、盘绕的、弯曲的、变形的、螺旋形的、环绕的和/或弓形的。任选地,与本文所述的纤维和线圈类似,弹簧线圈20686可包含聚合物组合物。此外,弹簧线圈20686可至少部分地具有弹性,使得弹簧线圈20686的变形产生恢复力。弹簧线圈20686可包括第一末端20687、第二末端20689和两者间的纵向轴线。参见图71,弹簧线圈20686的第一末端20686可定位在组织厚度补偿件的近侧末端20626处或附近,并且相同弹簧线圈20686的第二末端20689可定位在组织厚度补偿件20620的远侧末端20625处或附近,使得例如弹簧线圈20686纵向地横贯组织厚度补偿件20620。作为另外一种选择,盘绕纤维20686可侧向地或对角地横贯组织厚度补偿件20620。Referring primarily to FIGS. 71 and 72 , the tissue thickness compensator 20620 for the end effector 12 can include a plurality of spring coils 20686 . Similar to the crimped fibers 20086 and coiled fibers 20586 described herein, the spring coils 20686 can be, for example, crimped, twisted, coiled, bent, deformed, helical, looped within the tissue thickness compensator 20620 and/or arcuate. Optionally, spring coils 20686 may comprise a polymeric composition similar to the fibers and coils described herein. Additionally, the spring coil 20686 can be at least partially resilient such that deformation of the spring coil 20686 produces a restoring force. The spring coil 20686 can include a first end 20687, a second end 20689 and a longitudinal axis therebetween. Referring to FIG. 71 , a first end 20686 of a spring coil 20686 can be positioned at or near a proximal end 20626 of the tissue thickness compensator, and a second end 20689 of the same spring coil 20686 can be positioned at a distal end of the tissue thickness compensator 20620 20625 such that, for example, spring coil 20686 traverses longitudinally across tissue thickness compensator 20620. Alternatively, coiled fibers 20686 may traverse tissue thickness compensator 20620 laterally or diagonally.
组织厚度补偿件20620可包括外膜20680,该外膜20680至少部分地围绕至少一个弹簧线圈20686。参见图71,外膜20680可围绕组织厚度补偿件20620中的多个弹簧线圈20686的周边延伸。作为另外一种选择,外膜20680可完全封装组织厚度补偿件20620中的弹簧线圈20686或至少一个弹簧线圈20686。外膜20680可将弹簧线圈20686保持在端部执行器12中。外膜20680可将弹簧线圈20686保持在加载位置,使得弹簧线圈20686产生弹簧负载并且对外膜20680施加回弹力。作为另外一种选择,外膜20680可将弹簧线圈20686保持在中立位置。组织厚度补偿件20620还可包含填充材料20624。填充材料20624可由外膜20680保持在弹簧线圈20686内和/或周围。填充材料20624可包含治疗剂20688,类似于本文所述的治疗剂。此外,填充材料20624可支撑组织厚度补偿件20620内的弹簧线圈20686。填充材料20624可以是可压缩的并且至少部分地具有弹性,使得填充材料20624有助于由组织厚度补偿件20620产生的回弹力或恢复力,如本文更详细地描述。Tissue thickness compensator 20620 can include an outer membrane 20680 at least partially surrounding at least one spring coil 20686 . Referring to FIG. 71 , an adventitia 20680 can extend around the perimeter of a plurality of spring coils 20686 in a tissue thickness compensator 20620 . Alternatively, the outer membrane 20680 may completely encapsulate the spring coils 20686 or at least one spring coil 20686 in the tissue thickness compensator 20620 . The outer membrane 20680 can retain the spring coil 20686 in the end effector 12 . The outer membrane 20680 can hold the spring coil 20686 in the loaded position such that the spring coil 20686 creates a spring load and exerts a resilient force on the outer membrane 20680. Alternatively, the outer membrane 20680 can hold the spring coil 20686 in a neutral position. The tissue thickness compensator 20620 may also comprise a filler material 20624. Fill material 20624 may be retained within and/or around spring coils 20686 by outer membrane 20680 . The filler material 20624 can comprise a therapeutic agent 20688, similar to the therapeutic agents described herein. Additionally, the filler material 20624 can support the spring coils 20686 within the tissue thickness compensator 20620 . The filler material 20624 can be compressible and at least partially elastic, such that the filler material 20624 contributes to a resilient or restoring force generated by the tissue thickness compensator 20620, as described in greater detail herein.
与本文所述的组织厚度补偿件类似,组织厚度补偿件20620可以是可压缩的。当钉20030(图78-图81)被从初始位置部署到击发位置时,钉20030可接合组织厚度补偿件20620的一部分。任选地,每个钉20030可捕获组织厚度补偿件20620的一部分连同相邻组织T。钉20030可向组织厚度补偿件20620的被捕获部分和被捕获组织T施加压缩力,使得组织厚度补偿件20620被压缩在未压缩高度和压缩高度之间。组织厚度补偿件20620的压缩可导致保持在其中的弹簧线圈20686的对应变形(图72)。如本文更详细地描述,每个弹簧线圈20686的变形均可产生恢复力,该恢复力取决于弹簧线圈20686的回弹力,例如,弹簧线圈20686的变形量和/或弹簧线圈20686的弹簧劲度系数。弹簧线圈20686的弹簧劲度系数可至少取决于例如弹簧线圈20686的材料、形状和/或尺寸。此外,根据填充材料20624和外膜20680的回弹力,填充材料20624和/或外膜20680的压缩还可产生恢复力。至少由组织厚度补偿件20620中的变形弹簧线圈20686、填充材料20624和/或外膜20680产生的恢复力的总和可在整个组织厚度补偿件20620上产生恢复力。组织厚度补偿件20620可对击发钉20030中的被捕获组织T施加由变形弹簧线圈20686产生的恢复力总和。Similar to the tissue thickness compensators described herein, the tissue thickness compensator 20620 can be compressible. The staples 20030 ( FIGS. 78-81 ) can engage a portion of the tissue thickness compensator 20620 when the staples 20030 ( FIGS. 78-81 ) are deployed from an initial position to a fired position. Optionally, each staple 20030 can capture a portion of the tissue thickness compensator 20620 along with adjacent tissue T. The staples 20030 can apply a compressive force to the captured portion of the tissue thickness compensator 20620 and the captured tissue T such that the tissue thickness compensator 20620 is compressed between an uncompressed height and a compressed height. Compression of the tissue thickness compensator 20620 can cause a corresponding deformation of the spring coils 20686 retained therein (FIG. 72). As described in greater detail herein, deformation of each spring coil 20686 can produce a restoring force that depends on the resilience of the spring coil 20686, for example, the amount of deformation of the spring coil 20686 and/or the spring stiffness of the spring coil 20686 coefficient. The spring rate of the spring coil 20686 can depend at least on the material, shape and/or size of the spring coil 20686, for example. Additionally, compression of the filler material 20624 and/or the outer membrane 20680 may also generate a restoring force based on the resilience of the filler material 20624 and the outer membrane 20680 . At least the sum of the restoring forces generated by the deformed spring coils 20686 , the filler material 20624 , and/or the outer membrane 20680 in the tissue thickness compensator 20620 can generate a restoring force across the entire tissue thickness compensator 20620 . The tissue thickness compensator 20620 can apply the sum of the restoring forces generated by the deformed spring coils 20686 to the captured tissue T in the fired staples 20030 .
任选地,主要参见图73-图75,用于端部执行器12的组织厚度补偿件20720可包括多个弹簧线圈20786。与本文所述的盘绕纤维和弹簧类似,弹簧线圈20786在组织厚度补偿件20720内可为(例如)卷曲的、扭曲的、盘绕的、弯曲的、变形的、螺旋形的、环绕的和/或弓形的。弹簧线圈20786可至少部分地具有弹性,使得弹簧线圈20786的变形产生恢复力。此外,弹簧线圈20786可包括第一末端20787、第二末端20789和两者间的纵向轴线。主要参见图75,弹簧线圈20786的第一末端20787可定位在组织厚度补偿件20720的近侧末端20726处或附近,并且弹簧线圈20786的第二末端20789可定位在组织厚度补偿件20720的远侧末端20725处或附近,使得弹簧线圈20786纵向地横贯组织厚度补偿件20720。弹簧线圈20786可在组织厚度补偿件20720中沿两个平行行纵向延伸。组织厚度补偿件20720可定位在端部执行器12中,使得滑动件20050(图61)或切割元件20052可沿着平行行的弹簧线圈20786之间的狭槽20015平移。作为另外一种选择,弹簧线圈20786可侧向地或对角地横贯组织厚度补偿件20720。Optionally, referring primarily to FIGS. 73-75 , the tissue thickness compensator 20720 for the end effector 12 can include a plurality of spring coils 20786 . Similar to the coiled fibers and springs described herein, the spring coils 20786 can be, for example, coiled, twisted, coiled, bent, deformed, helical, looped, and/or within the tissue thickness compensator 20720 arched. The spring coils 20786 can be at least partially resilient such that deformation of the spring coils 20786 produces a restoring force. Additionally, the spring coil 20786 can include a first end 20787, a second end 20789, and a longitudinal axis therebetween. Referring primarily to FIG. 75 , the first end 20787 of the spring coil 20786 can be positioned at or near the proximal end 20726 of the tissue thickness compensator 20720 and the second end 20789 of the spring coil 20786 can be positioned distal to the tissue thickness compensator 20720 At or near the end 20725 such that the spring coil 20786 traverses the tissue thickness compensator 20720 longitudinally. Spring coils 20786 can extend longitudinally within tissue thickness compensator 20720 in two parallel rows. Tissue thickness compensator 20720 can be positioned in end effector 12 such that sled 20050 ( FIG. 61 ) or cutting element 20052 can translate along slot 20015 between parallel rows of spring coils 20786 . Alternatively, spring coils 20786 may traverse tissue thickness compensator 20720 laterally or diagonally.
再次参见图75,弹簧线圈20786可保持或嵌入补偿材料20780中。补偿材料20780可为可生物吸收的,并且在一些情况下,可包含泡沫,诸如聚乙醇酸(PGA)泡沫。补偿材料20780可具有弹性,使得补偿材料20780的变形产生回弹力。补偿材料20780在例如叶绿素溶剂中可为可溶的。例如,组织厚度补偿件可例如包括含有聚己内酯(PCL)的弹簧线圈20786和含有聚乙醇酸(PGA)泡沫的补偿材料20780,使得弹簧线圈20786在叶绿素溶剂中为不可溶的,而补偿材料20780在叶绿素溶剂中为可溶的。补偿材料20780可至少部分地具有弹性,使得补偿材料20780的变形产生弹簧负载或恢复力。Referring again to FIG. 75 , spring coils 20786 may be retained or embedded in compensating material 20780 . Compensation material 20780 may be bioabsorbable, and in some cases, may comprise foam, such as polyglycolic acid (PGA) foam. The compensating material 20780 may be elastic such that deformation of the compensating material 20780 produces a resilient force. The compensation material 20780 may be soluble in, for example, a chlorophyll solvent. For example, the tissue thickness compensator can include, for example, a spring coil 20786 comprising polycaprolactone (PCL) and a compensating material 20780 comprising polyglycolic acid (PGA) foam, such that the spring coil 20786 is insoluble in a chlorophyll solvent while compensating Material 20780 is soluble in chlorophyll solvent. The compensation material 20780 can be at least partially elastic such that deformation of the compensation material 20780 creates a spring load or restoring force.
组织厚度补偿件20720可包括交织线20790,其可在平行行的弹簧线圈20786之间延伸。例如,参见图75,第一交织线20790可对角地横贯两个平行行的弹簧线圈20786,并且第二交织线20790还可对角地横贯两个平行行的弹簧线圈20786。第一和第二交织线20790可交叉。交织线20790可沿着组织厚度补偿件20720的长度多次交叉。交织线20790可将弹簧线圈20786保持在加载构型中,使得弹簧线圈20786被保持在组织厚度补偿件20720中的基本平坦位置。横贯组织厚度补偿件20720的交织线20790可直接附接到弹簧线圈20786。作为另外一种选择,交织线20790可经由支撑件20792联接到弹簧线圈20786,该支撑件20792沿着弹簧线圈20786的纵向轴线延伸穿过每个弹簧线圈20786。Tissue thickness compensator 20720 can include interwoven wires 20790 that can extend between parallel rows of spring coils 20786 . For example, referring to FIG. 75 , a first interweaving wire 20790 may traverse diagonally across two parallel rows of spring coils 20786 and a second interweaving wire 20790 may also diagonally traverse two parallel rows of spring coils 20786 . The first and second interweaving lines 20790 may intersect. The interweaving wires 20790 may cross along the length of the tissue thickness compensator 20720 multiple times. Braided wire 20790 can maintain spring coil 20786 in a loaded configuration such that spring coil 20786 is maintained in a substantially flat position within tissue thickness compensator 20720 . The interwoven wires 20790 traversing the tissue thickness compensator 20720 can be attached directly to the spring coils 20786. Alternatively, the interwoven wire 20790 may be coupled to the spring coils 20786 via a support 20792 that extends through each spring coil 20786 along the longitudinal axis of the spring coils 20786 .
如本文更详细地描述,钉仓20000可包括狭槽20015,其能够接收包括切割元件20052的平移滑动件20050(图61)。当滑动件20050沿着狭槽20015平移时,滑动件20050可将钉20030从钉仓20000中的紧固件腔20012中射出,并且切割元件20052可同时或几乎同时切断组织T。再次参见图75,当切割元件20052平移时,其还可切断在组织厚度补偿件20720中的平行行弹簧线圈20786之间交叉的交织线20790。当交织线20790被切断时,每个弹簧线圈20786可从其加载构型被释放,使得每个弹簧线圈20786从组织厚度补偿件20720中加载的基本平坦位置恢复至膨胀位置。任选地,当弹簧线圈20786膨胀时,围绕弹簧线圈20786的补偿材料20780也可膨胀。As described in greater detail herein, the staple cartridge 20000 can include a slot 20015 configured to receive a translating sled 20050 ( FIG. 61 ) that includes a cutting element 20052 . As the sled 20050 translates along the slot 20015, the sled 20050 can eject the staples 20030 from the fastener cavities 20012 in the staple cartridge 20000 and the cutting elements 20052 can simultaneously or nearly simultaneously sever the tissue T. Referring again to FIG. 75 , when the cutting element 20052 translates, it can also sever the interwoven wires 20790 that cross between parallel rows of spring coils 20786 in the tissue thickness compensator 20720 . When the interwoven strands 20790 are severed, each spring coil 20786 can be released from its loaded configuration such that each spring coil 20786 returns to an expanded position from a loaded substantially flat position in the tissue thickness compensator 20720 . Optionally, when the spring coil 20786 expands, the compensating material 20780 surrounding the spring coil 20786 may also expand.
任选地,当钉20030(图78-图81)被从初始位置部署到击发位置时,钉20030可接合组织厚度补偿件20720的一部分,并且组织厚度补偿件20720可在钉20030内膨胀或尝试膨胀,并且可向组织T施加压缩力。任选地,至少一个钉20030可捕获组织厚度补偿件20720的一部分连同相邻组织T。钉20030可向组织厚度补偿件20720的被捕获部分以及被捕获组织T施加压缩力,使得组织厚度补偿件20720被压缩在未压缩高度和压缩高度之间。组织厚度补偿件20720的压缩可导致弹簧线圈20786和保持在其中的补偿材料20780的对应变形。如本文更详细地描述,每个弹簧线圈20786的变形均可产生恢复力,该恢复力可取决于弹簧线圈的回弹力,例如,弹簧线圈20786的变形量和/或弹簧线圈20786的弹簧劲度系数。弹簧线圈20786的弹簧劲度系数可至少取决于例如弹簧线圈20786的取向、材料、形状和/或尺寸。由组织厚度补偿件20720中的至少变形弹簧线圈20786和/或补偿材料30380产生的恢复力的总和可在整个组织厚度补偿件20720上产生恢复力。组织厚度补偿件20720可对被捕获组织T和击发钉20030施加由组织厚度补偿件20720中的变形弹簧线圈20786产生的恢复力总和。Optionally, when the staples 20030 ( FIGS. 78-81 ) are deployed from the initial position to the fired position, the staples 20030 can engage a portion of the tissue thickness compensator 20720 and the tissue thickness compensator 20720 can expand or try to expand within the staples 20030 expands and can apply a compressive force to the tissue T. Optionally, at least one staple 20030 can capture a portion of the tissue thickness compensator 20720 along with adjacent tissue T. The staples 20030 can apply a compressive force to the captured portion of the tissue thickness compensator 20720 and the captured tissue T such that the tissue thickness compensator 20720 is compressed between an uncompressed height and a compressed height. Compression of the tissue thickness compensator 20720 can cause a corresponding deformation of the spring coils 20786 and the compensating material 20780 retained therein. As described in greater detail herein, deformation of each spring coil 20786 can produce a restoring force that can depend on the resilience of the spring coil, for example, the amount of deformation of the spring coil 20786 and/or the spring stiffness of the spring coil 20786 coefficient. The spring rate of the spring coil 20786 can depend at least on the orientation, material, shape and/or size of the spring coil 20786, for example. The sum of the restoring forces generated by at least the deformable spring coils 20786 and/or the compensating material 30380 in the tissue thickness compensator 20720 can generate a restoring force across the entire tissue thickness compensator 20720 . The tissue thickness compensator 20720 can apply the sum of the restoring forces generated by the deformed spring coils 20786 in the tissue thickness compensator 20720 to the captured tissue T and the fired staples 20030 .
任选地,主要参见图76和图77,用于外科端部执行器12的组织厚度补偿件20820可包括弹簧线圈20886。与本文所述的纤维和线圈类似,弹簧线圈20886在组织厚度补偿件20820内可为(例如)卷曲的、扭曲的、盘绕的、弯曲的、变形的、螺旋形的、环绕的和/或弓形的。弹簧线圈20886可包含聚合物组合物并且可至少部分地具有弹性,使得弹簧线圈20886的变形产生回弹力。此外,弹簧线圈20886可包括第一末端20887和第二末端20889。参见图76,第一末端20887可定位在组织厚度补偿件20820的近侧末端20826处或附近,并且第二末端20889可定位在组织厚度补偿件20820的远侧末端20825处或附近。弹簧线圈20886可从组织厚度补偿件20820的近侧末端20825缠绕或弯折到远侧末端20826。Optionally, referring primarily to FIGS. 76 and 77 , the tissue thickness compensator 20820 for the surgical end effector 12 can include a spring coil 20886 . Similar to the fibers and coils described herein, the spring coils 20886 can be, for example, crimped, twisted, coiled, curved, deformed, helical, looped, and/or arcuate within the tissue thickness compensator 20820 of. The spring coils 20886 can comprise a polymer composition and can be at least partially elastic such that deformation of the spring coils 20886 produces a resilient force. Additionally, the spring coil 20886 can include a first end 20887 and a second end 20889 . Referring to FIG. 76 , the first end 20887 can be positioned at or near the proximal end 20826 of the tissue thickness compensator 20820 and the second end 20889 can be positioned at or near the distal end 20825 of the tissue thickness compensator 20820 . The spring coil 20886 can be wound or bent from the proximal end 20825 to the distal end 20826 of the tissue thickness compensator 20820.
再次参见图76,弹簧线圈20886可保持或嵌入补偿材料20880中。补偿材料20880可为可生物吸收的,并且在一些情况下,可包含泡沫,诸如聚乙醇酸(PGA)泡沫。补偿材料20880在例如叶绿素溶剂中可为可溶的。组织厚度补偿件可例如包括含有聚己内酯(PCL)的弹簧线圈20886和含有聚乙醇酸(PGA)泡沫的补偿材料20880,使得弹簧线圈20886在叶绿素溶剂中为不可溶的,而补偿材料20880在叶绿素溶剂中为可溶的。补偿材料20880可至少部分地具有弹性,使得补偿材料20880的变形产生弹簧负载或恢复力。Referring again to FIG. 76 , spring coils 20886 may be retained or embedded in compensating material 20880 . Compensation material 20880 may be bioabsorbable and, in some cases, may comprise foam, such as polyglycolic acid (PGA) foam. The compensation material 20880 may be soluble in, for example, a chlorophyll solvent. The tissue thickness compensator may, for example, comprise a spring coil 20886 comprising polycaprolactone (PCL) and a compensating material 20880 comprising polyglycolic acid (PGA) foam such that the spring coil 20886 is insoluble in chlorophyll solvents and the compensating material 20880 It is soluble in chlorophyll solvent. The compensation material 20880 can be at least partially elastic such that deformation of the compensation material 20880 creates a spring load or restoring force.
与本文所述的组织厚度补偿件类似,例如,组织厚度补偿件20820可以是可压缩的。组织厚度补偿件20820的压缩可导致保持或嵌入组织厚度补偿件20820中的补偿材料20880中的弹簧线圈20886的至少一部分变形。如本文更详细地描述,弹簧线圈20886的变形可产生恢复力,该恢复力可取决于例如弹簧线圈20886的回弹力、弹簧线圈20886的变形量和/或弹簧线圈20886的弹簧劲度系数。由变形弹簧线圈20886和/或变形补偿材料20880产生的恢复力的总和可在整个组织厚度补偿件20820上产生恢复力。组织厚度补偿件20820可对击发钉20030中的被捕获组织T施加恢复力总和。Similar to the tissue thickness compensators described herein, for example, the tissue thickness compensator 20820 can be compressible. Compression of the tissue thickness compensator 20820 can cause deformation of at least a portion of the spring coils 20886 retained or embedded in the compensating material 20880 within the tissue thickness compensator 20820 . As described in greater detail herein, deformation of the spring coil 20886 can generate a restoring force that can depend on, for example, the springback force of the spring coil 20886, the amount of deformation of the spring coil 20886, and/or the spring rate of the spring coil 20886. The sum of the restoring forces generated by the deformed spring coils 20886 and/or the deformed compensating material 20880 can generate a restoring force across the entire tissue thickness compensator 20820. The tissue thickness compensator 20820 can apply a sum of restoring forces to the captured tissue T in the fired staples 20030 .
现在参见图84,外科端部执行器12可包括具有至少一个管状元件30080的组织厚度补偿件30020。组织厚度补偿件30020可保持在外科端部执行器12中。如本文更详细地描述,可部署端部执行器12中的紧固件,使得紧固件运动至击发位置并且使组织厚度补偿件30020中的管状元件30080的至少一部分变形。读者将会知道,包括如本文所述的至少一个管状元件的组织厚度补偿件可安装在多种外科端部执行器中或以其他的方式与多种外科端部执行器接合,并且这些在本发明的范围内。Referring now to FIG. 84 , the surgical end effector 12 can include a tissue thickness compensator 30020 having at least one tubular element 30080 . Tissue thickness compensator 30020 can be retained in surgical end effector 12 . As described in greater detail herein, fasteners in end effector 12 may be deployed such that the fasteners move to the fired position and deform at least a portion of tubular element 30080 in tissue thickness compensator 30020 . The reader will appreciate that a tissue thickness compensator comprising at least one tubular element as described herein may be installed in or otherwise engaged with a variety of surgical end effectors, and that these are discussed in this within the scope of the invention.
任选地,仍参见图84,组织厚度补偿件30020可相对于端部执行器12的砧座30060定位。作为另外一种选择,组织厚度补偿件30020可相对于端部执行器12的紧固件仓组件(诸如钉仓30000)定位。钉仓30000能够配合在端部执行器12的钳口30070的仓通道30072中。例如,组织厚度补偿件30020能够可释放地固定到钉仓30000。组织厚度补偿件30020的管状元件30080可邻近钉仓30000的刚性支撑部分30010的顶部平台表面30011而定位。管状元件30080可通过粘合剂或通过包裹物(与本文所述的包裹物中的至少一者类似)(例如,图16)固定到顶部平台表面30011。组织厚度补偿件30020可与包括钉仓30000的组件成一整体,使得钉仓30000和组织厚度补偿件30020形成为单个单元构造。例如,钉仓30000可包括例如第一主体部分,诸如刚性支撑部分30010,和第二主体部分,诸如组织厚度补偿件30020。Optionally, still referring to FIG. 84 , tissue thickness compensator 30020 can be positioned relative to anvil 30060 of end effector 12 . Alternatively, tissue thickness compensator 30020 may be positioned relative to a fastener cartridge assembly of end effector 12, such as staple cartridge 30000. The staple cartridge 30000 is configured to fit within the cartridge channel 30072 of the jaw 30070 of the end effector 12 . For example, tissue thickness compensator 30020 can be releasably secured to staple cartridge 30000. Tubular element 30080 of tissue thickness compensator 30020 can be positioned adjacent top deck surface 30011 of rigid support portion 30010 of staple cartridge 30000 . Tubular member 30080 may be secured to top deck surface 30011 by adhesive or by a wrap (similar to at least one of the wraps described herein) (eg, FIG. 16 ). Tissue thickness compensator 30020 can be integral with an assembly including staple cartridge 30000 such that staple cartridge 30000 and tissue thickness compensator 30020 are formed as a single unit configuration. For example, staple cartridge 30000 can include a first body portion, such as rigid support portion 30010 , and a second body portion, such as tissue thickness compensator 30020 , for example.
参见图84-图86,组织厚度补偿件30020中的管状元件30080可包括细长部分30082,该细长部分30082具有至少部分地延伸穿过其中的至少一个管腔30084。主要参见图86,管状元件30080的细长部分30082可包括织造或编织股线30090,如本文更详细地描述。作为另外一种选择,细长部分30082可包括实心结构,诸如聚合物挤出物,而不是织造股线30090。管状元件30080的细长部分30082可包括厚度。细长部分30082的厚度可在其整个长度内并且围绕其直径为基本上均匀的;在其他情况下,该厚度可以变化。细长部分30082可为细长的,使得例如细长部分30082的长度大于细长部分30082的直径。细长部分可包括例如大约1.20英寸至大约2.60英寸的长度和大约0.10英寸至大约0.15英寸的直径。管状元件20080的长度可为例如大约1.40英寸,并且管状元件20080的直径可为例如大约0.125英寸。此外,细长部分30082可限定例如基本上圆形的或椭圆的横截面形状。作为另外一种选择,横截面形状可包括多边形形状,诸如三角形、六边形和/或八边形。再次参见图84,管状元件30080可包括第一远侧末端30083和第二近侧末端30085。细长部分30082的横截面形状可在第一末端30083和/或第二末端30085处变窄,其中管状元件30080的至少一个端部30083、30085可闭合和/或密封。作为另外一种选择,管腔30084可继续穿过管状元件30080的远侧末端30083、30085,使得端部30083、30085为开放的。84-86, the tubular member 30080 in the tissue thickness compensator 30020 can include an elongated portion 30082 having at least one lumen 30084 extending at least partially therethrough. Referring primarily to FIG. 86, the elongated portion 30082 of the tubular member 30080 can comprise woven or braided strands 30090, as described in greater detail herein. Alternatively, elongated portion 30082 may comprise a solid structure, such as a polymer extrusion, rather than woven strands 30090 . The elongated portion 30082 of the tubular element 30080 can include a thickness. The thickness of the elongated portion 30082 can be substantially uniform throughout its length and around its diameter; in other cases, the thickness can vary. The elongated portion 30082 can be elongated such that, for example, the length of the elongated portion 30082 is greater than the diameter of the elongated portion 30082 . The elongated portion can include, for example, a length of about 1.20 inches to about 2.60 inches and a diameter of about 0.10 inches to about 0.15 inches. The length of the tubular element 20080 can be, for example, about 1.40 inches, and the diameter of the tubular element 20080 can be, for example, about 0.125 inches. Additionally, elongate portion 30082 can define a substantially circular or elliptical cross-sectional shape, for example. Alternatively, the cross-sectional shape may include polygonal shapes, such as triangles, hexagons, and/or octagons. Referring again to FIG. 84 , the tubular element 30080 can include a first distal end 30083 and a second proximal end 30085 . The cross-sectional shape of the elongated portion 30082 can narrow at a first end 30083 and/or a second end 30085, wherein at least one end 30083, 30085 of the tubular element 30080 can be closed and/or sealed. Alternatively, the lumen 30084 may continue through the distal ends 30083, 30085 of the tubular element 30080 such that the ends 30083, 30085 are open.
管状元件30080可包括至少部分地延伸穿过细长部分30084的单个中心管腔30084。管腔30084可延伸穿过细长部分30084的整个长度。作为另外的另选形式,管状元件30080可包括延伸穿过其中的多个管腔30084。延伸穿过管状元件30080的管腔30084可为圆形、半圆形、楔形和/或它们的组合。根据本发明,管状元件30080还可包括支撑纤维网,其可在管腔30084内形成例如改性的“T”或“X”形状。管状元件30080内的尺寸、管腔和/或支撑纤维网可限定管状元件30080的横截面形状。管状元件30080的横截面形状在其整个长度内可为一致的,或作为另外一种选择,管状元件30080的横截面形状可沿着其长度以变化。如本文更详细地描述,管状元件30080的横截面形状可影响管状元件30080的可压缩性和回弹力。The tubular element 30080 can include a single central lumen 30084 extending at least partially through the elongated portion 30084 . The lumen 30084 can extend through the entire length of the elongated portion 30084. As a further alternative, the tubular member 30080 may include a plurality of lumens 30084 extending therethrough. The lumen 30084 extending through the tubular element 30080 can be circular, semi-circular, wedge-shaped, and/or combinations thereof. Tubular member 30080 may also include a supportive web that may form, for example, a modified "T" or "X" shape within lumen 30084 in accordance with the present invention. The dimensions, lumen, and/or supportive web within tubular element 30080 can define the cross-sectional shape of tubular element 30080 . The cross-sectional shape of the tubular element 30080 can be consistent throughout its length, or alternatively, the cross-sectional shape of the tubular element 30080 can vary along its length. As described in greater detail herein, the cross-sectional shape of the tubular element 30080 can affect the compressibility and resiliency of the tubular element 30080 .
管状元件30080可包括垂直直径和水平直径;其尺寸可根据端部执行器12中的管状元件30080的构造、端部执行器12的尺寸(包括端部执行器12的组织间隙)、和钉截留区域30039的预期几何形状来选择。例如,管状元件30080的垂直直径可与成形钉的预期高度有关。在此类情况下,可选择管状元件30080的垂直直径,使得当管状元件30080被捕获在成形钉30030内时,垂直直径可减小大约5%至大约20%。例如,垂直直径为大约0.100英寸的管状元件30080可用于预期成形高度为大约0.080英寸至大约0.095英寸的钉。因此,当管状元件30080被捕获在成形钉30030内时,即使在其中未捕获任何组织T,管状元件30080的垂直直径也可减小大约5%至大约20%。当组织T被捕获在成形钉30030内时,管状元件30080的压缩甚至可更大。垂直直径在管状元件30080的整个长度内可为均一的,或作为另外一种选择,垂直直径可沿其长度变化。Tubular member 30080 can include a vertical diameter and a horizontal diameter; its size can be based on the configuration of tubular member 30080 in end effector 12, the size of end effector 12 (including the tissue gap of end effector 12), and staple entrapment The expected geometry of the region 30039 is selected. For example, the vertical diameter of the tubular element 30080 can be related to the desired height of the formed staples. In such cases, the vertical diameter of the tubular elements 30080 can be selected such that when the tubular elements 30080 are captured within the forming staples 30030, the vertical diameter can be reduced by about 5% to about 20%. For example, a tubular member 30080 having a vertical diameter of about 0.100 inches may be used for staples having an expected formed height of about 0.080 inches to about 0.095 inches. Accordingly, when the tubular elements 30080 are captured within the formed staples 30030, the vertical diameter of the tubular elements 30080 may be reduced by about 5% to about 20%, even though no tissue T is captured therein. When the tissue T is captured within the formed staples 30030, the compression of the tubular elements 30080 can be even greater. The vertical diameter may be uniform throughout the length of the tubular element 30080, or alternatively, the vertical diameter may vary along its length.
当管状元件30080处于未变形或回弹构型时,管状元件30080的水平直径可大于、等于或小于管状元件30080的垂直直径。例如,参见图85,水平直径可比垂直直径大例如大约三倍。例如,水平直径可为大约0.400英寸并且垂直直径可为大约0.125英寸。作为另外一种选择,现在参见图87,当管状元件31080处于未变形或回弹构型时,管状元件31080的水平直径可等于或基本上等于管状元件31080的垂直直径。例如,水平直径可为大约0.125英寸并且垂直直径也可为大约0.125英寸。管状元件30080可包括大约0.125英寸的垂直直径、大约0.400英寸的水平直径和大约1.400英寸的长度。如本文更详细地描述,当将力A施加于管状元件30080和/或31080时,管状元件可变形,使得横截面几何形状(包括水平和垂直直径)可变化。The horizontal diameter of the tubular element 30080 can be greater than, equal to, or smaller than the vertical diameter of the tubular element 30080 when the tubular element 30080 is in the undeformed or resilient configuration. For example, referring to Fig. 85, the horizontal diameter may be larger, eg, about three times, than the vertical diameter. For example, the horizontal diameter may be about 0.400 inches and the vertical diameter may be about 0.125 inches. Alternatively, referring now to Fig. 87, the horizontal diameter of the tubular element 31080 may be equal or substantially equal to the vertical diameter of the tubular element 31080 when the tubular element 31080 is in the undeformed or resilient configuration. For example, the horizontal diameter may be about 0.125 inches and the vertical diameter may also be about 0.125 inches. Tubular member 30080 can include a vertical diameter of approximately 0.125 inches, a horizontal diameter of approximately 0.400 inches, and a length of approximately 1.400 inches. As described in greater detail herein, when a force A is applied to tubular elements 30080 and/or 31080, the tubular elements can be deformed such that the cross-sectional geometry (including horizontal and vertical diameters) can vary.
再次参见图84-图86,组织厚度补偿件30020中的管状元件30080可为可变形的。整个管状元件30080可为可变形的。例如,管状元件30080可从细长部分30082的近侧末端30083至远侧末端30085并且围绕其整个周长可为可变形的。作为另外一种选择,管状元件30080的仅一部分可为可变形的。例如,细长部分30082的仅中间长度和/或管状元件30080的周长的仅一部分可为可变形的。Referring again to FIGS. 84-86 , the tubular element 30080 in the tissue thickness compensator 30020 can be deformable. The entire tubular element 30080 may be deformable. For example, the tubular element 30080 can be deformable from the proximal end 30083 to the distal end 30085 of the elongated portion 30082 and around its entire perimeter. Alternatively, only a portion of the tubular element 30080 may be deformable. For example, only an intermediate length of the elongated portion 30082 and/or only a portion of the circumference of the tubular element 30080 may be deformable.
当将压缩力施加于管状元件30080的细长部分30082上的接触点时,接触点可偏移,这可改变管状元件30080的横截面尺寸。例如,再次参见图85,管状元件30080可包括细长部分30082上的顶部顶点30086和底部顶点30088。在初始未变形构型中,管状元件30080可包括未变形横截面尺寸,包括顶部顶点30086与底部顶点30088之间的未变形垂直直径。当将压缩力A施加于顶部顶点30086时,管状元件30080可运动至变形构型。在变形构型中,管30080的横截面尺寸可改变。例如,管30086可包括顶部顶点30086与底部顶点30088之间的变形垂直直径,该变形垂直直径可小于未变形垂直直径。参见图87,例如,当管状元件30080从未变形构型运动至变形构型时,变形管30080的水平直径可被加长。变形管30080的变形横截面尺寸可至少取决于所施加力A的位置、角取向和/或大小。如本文更详细地描述,管状元件30080的变形可产生回弹力或恢复力,其可取决于管状元件30080的回弹力。When a compressive force is applied to the contact point on the elongate portion 30082 of the tubular member 30080, the contact point may deflect, which may change the cross-sectional dimension of the tubular member 30080. For example, referring again to FIG. 85 , the tubular member 30080 can include a top apex 30086 and a bottom apex 30088 on the elongated portion 30082 . In the initial undeformed configuration, the tubular element 30080 can include an undeformed cross-sectional dimension including an undeformed vertical diameter between a top apex 30086 and a bottom apex 30088 . When a compressive force A is applied to the top apex 30086, the tubular element 30080 is moveable to the deformed configuration. In the deformed configuration, the cross-sectional dimension of the tube 30080 may change. For example, the tube 30086 can include a deformed vertical diameter between the top apex 30086 and the bottom apex 30088, which can be smaller than the undeformed vertical diameter. Referring to Fig. 87, for example, the horizontal diameter of the deformed tube 30080 can be lengthened when the tubular element 30080 is moved from an undeformed configuration to a deformed configuration. The deformed cross-sectional dimension of the deformed tube 30080 may depend at least on the location, angular orientation, and/or magnitude of the applied force A. As described in greater detail herein, deformation of the tubular element 30080 can generate a resilient or restoring force, which can depend on the resilient force of the tubular element 30080 .
仍参见图85,管状元件30080在被压缩时可产生回弹力或恢复力。在此类情况下,如本文所述,当将力A施加于管状元件30080的细长部分30082上的接触点时,管状元件30080可从初始未变形构型运动至变形构型。当移除所施加的力A时,变形管30080可从变形构型回弹。变形管30080可回弹至初始未变形构型或可回弹至与初始未变形构型基本上类似的构型。管状元件30080从变形构型回弹的能力与管状元件30080的回弹力相关。Still referring to FIG. 85, the tubular element 30080 can generate a resilient or restoring force when compressed. In such cases, the tubular element 30080 can move from an initial, undeformed configuration to a deformed configuration when a force A is applied to a contact point on the elongate portion 30082 of the tubular element 30080, as described herein. When the applied force A is removed, the deformable tube 30080 can spring back from the deformed configuration. The deformed tube 30080 is resilient to an original undeformed configuration or is resilient to a configuration substantially similar to the initial undeformed configuration. The ability of the tubular element 30080 to rebound from the deformed configuration is related to the resilience of the tubular element 30080.
再次参见图85,管状元件30080可施加回弹力或恢复力。当例如通过钉30030(图88和图89)对管状元件30080施加所施加的力A时,可由管状元件30080产生恢复力,如本文更详细地描述。所施加的力A可改变管状元件30080的横截面尺寸。此外,在线性弹性材料中,管状元件30080的每个变形部分的恢复力可取决于管状元件30080的变形尺寸和管状元件30080的该部分的弹簧劲度系数。管状元件30080的弹簧劲度系数可至少取决于例如管状元件30080的取向、材料、横截面几何形状和/或尺寸。组织厚度补偿件30020中的管状元件30080可包括均一的弹簧劲度系数。作为另外一种选择,弹簧劲度系数可沿着管状元件30080的长度和/或围绕管状元件30080的直径变化。当具有第一弹簧劲度系数的管状元件30080的一部分被极大地压缩时,管状元件30080可产生较大恢复力。当具有相同第一弹簧劲度系数的管状元件30080的一部分被压缩得较少时,管状元件30080可产生较小恢复力。Referring again to FIG. 85, the tubular element 30080 can exert a resilient or restoring force. When an applied force A is applied to the tubular element 30080, such as by the staples 30030 (FIGS. 88 and 89), a restoring force can be generated by the tubular element 30080, as described in greater detail herein. The applied force A can change the cross-sectional dimension of the tubular element 30080. Furthermore, in a linear elastic material, the restoring force of each deformed portion of the tubular element 30080 may depend on the deformed dimension of the tubular element 30080 and the spring rate of that portion of the tubular element 30080. The spring rate of the tubular element 30080 can depend at least on the orientation, material, cross-sectional geometry and/or dimensions of the tubular element 30080, for example. The tubular element 30080 in the tissue thickness compensator 30020 can comprise a uniform spring rate. Alternatively, the spring rate may vary along the length of the tubular element 30080 and/or around the diameter of the tubular element 30080. When a portion of the tubular element 30080 having the first spring rate is greatly compressed, the tubular element 30080 can generate a large restoring force. The tubular element 30080 can generate less restoring force when a portion of the tubular element 30080 having the same first spring rate is compressed less.
再次参见图84,组织厚度补偿件30020中的管状元件30080可包含聚合物组合物。管状元件30080的细长部分30082可包含该聚合物组合物。此外,该聚合物组合物可包含至少部分弹性材料,使得管状元件30080的变形产生恢复力。该聚合物组合物可包含例如不可吸收的聚合物、可吸收的聚合物或它们的组合。合成聚合物的示例包括但不限于聚乙醇酸(PGA)、聚(乳酸)(PLA)、聚己内酯(PCL)、聚二氧杂环己酮(PDO)和它们的共聚物。例如,可吸收的聚合物可包括可生物吸收的生物相容性弹性体聚合物。此外,管状元件30080的聚合物组合物可包括合成聚合物、非合成聚合物或它们的组合。任选地,类似于本文在别处所述的聚合物组合物,管状元件30080的聚合物组合物可包括量不同(例如按重量百分比计)的可吸收的聚合物、不可吸收的聚合物、合成聚合物和/或非合成聚合物。Referring again to FIG. 84, the tubular element 30080 in the tissue thickness compensator 30020 can comprise a polymeric composition. The elongated portion 30082 of the tubular member 30080 can comprise the polymer composition. Additionally, the polymer composition may comprise at least partially an elastic material such that deformation of the tubular member 30080 produces a restoring force. The polymer composition may comprise, for example, a non-absorbable polymer, an absorbable polymer, or combinations thereof. Examples of synthetic polymers include, but are not limited to, polyglycolic acid (PGA), poly(lactic acid) (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. For example, absorbable polymers can include bioabsorbable biocompatible elastomeric polymers. Additionally, the polymer composition of tubular member 30080 can include synthetic polymers, non-synthetic polymers, or combinations thereof. Optionally, similar to the polymer compositions described elsewhere herein, the polymer composition of tubular member 30080 may include absorbable polymers, nonabsorbable polymers, synthetic polymers and/or non-synthetic polymers.
参见图84和图85,管状元件30080例如可包含治疗剂30098,诸如药物活性剂或药物。治疗剂30098可保持在管状元件30080的管腔30084中。细长部分30082可封装或部分封装治疗剂30098。除此之外或作为另外一种选择,细长部分30082的聚合物组合物可包含治疗剂30098。管状元件30080可释放治疗有效量的治疗剂30098。可在管状元件30080被吸收时释放治疗剂30098。例如,治疗剂30098可释放到流经管状元件30080上或穿过管状元件30080的流体,诸如血液。作为另外的另选形式,例如当钉30030(图88和图89)刺穿管状元件30080和/或当钉击发滑动件30050上的切割元件30052(图84)切割管状元件30080的一部分时,可释放治疗剂30098。治疗剂30098的示例可包括但不限于止血剂和药物,诸如,血纤维蛋白、凝血酶和/或氧化再生纤维素(ORC);抗炎剂药物,诸如双氯芬酸、阿司匹林、萘普生、舒林酸和/或氢化可的松;抗生素和抗微生物药物或抗微生物剂,诸如三氯生、离子银、氨苄青霉素、庆大霉素、多粘菌素B和/或氯霉素;抗癌剂,诸如顺铂、丝裂霉素和/或阿霉素;和/或生物制剂,诸如干细胞。Referring to Figures 84 and 85, the tubular member 30080 can comprise a therapeutic agent 30098, such as a pharmaceutically active agent or drug, for example. The therapeutic agent 30098 can be retained within the lumen 30084 of the tubular member 30080. Elongate portion 30082 can encapsulate or partially encapsulate therapeutic agent 30098. Additionally or alternatively, the polymer composition of the elongated portion 30082 may comprise a therapeutic agent 30098. The tubular element 30080 can release a therapeutically effective amount of a therapeutic agent 30098. The therapeutic agent 30098 can be released as the tubular element 30080 is absorbed. For example, therapeutic agent 30098 may be released into fluid, such as blood, flowing over or through tubular element 30080 . As a further alternative, for example, when the staple 30030 ( FIGS. 88 and 89 ) pierces the tubular element 30080 and/or when the cutting element 30052 ( FIG. 84 ) on the staple firing slide 30050 cuts a portion of the tubular element 30080 , the Release therapeutic agent 30098. Examples of therapeutic agents 30098 may include, but are not limited to, hemostatic agents and drugs such as fibrin, thrombin, and/or oxidized regenerated cellulose (ORC); anti-inflammatory agent drugs such as diclofenac, aspirin, naproxen, sulindac acid and/or hydrocortisone; antibiotics and antimicrobial drugs or antimicrobial agents such as triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, and/or chloramphenicol; anticancer agents , such as cisplatin, mitomycin, and/or doxorubicin; and/or biological agents, such as stem cells.
再次参见图84、图88和图89,例如紧固件(诸如钉30030)可从钉仓30000被部署,使得钉30030接合组织厚度补偿件30020并且对其中的管状元件32080施加力A。如本文所述,对管状元件30080施加力A可导致管状元件30080变形。与本文所述的端部执行器12类似,钉仓30000的刚性支撑部分30010可包括仓体30017、平台表面30011以及其中的多个钉腔30012。每个钉腔30012可限定平台表面30011中的开口并且钉30030能够可移除地定位在钉腔30012中(图104)。主要参见图88和图89,每个钉30030可包括基部30031以及从基部30031延伸的两个钉腿30032。在部署钉30030之前,每个钉30030的基部30031可由定位在钉仓30000的刚性支撑部分30010内的钉驱动器30040(图104)支撑。另外在部署钉30030之前,每个钉30030的腿30032可至少部分地包含在钉腔30012(图104)内。Referring again to FIGS. 84 , 88 and 89 , for example, fasteners such as staples 30030 can be deployed from staple cartridge 30000 such that staples 30030 engage tissue thickness compensator 30020 and apply force A to tubular element 32080 therein. As described herein, applying a force A to the tubular element 30080 can cause the tubular element 30080 to deform. Similar to the end effector 12 described herein, the rigid support portion 30010 of the staple cartridge 30000 can include a cartridge body 30017, a deck surface 30011, and a plurality of staple cavities 30012 therein. Each staple cavity 30012 can define an opening in the deck surface 30011 and a staple 30030 can be removably positionable in the staple cavity 30012 ( FIG. 104 ). Referring primarily to FIGS. 88 and 89 , each staple 30030 can include a base 30031 and two staple legs 30032 extending from the base 30031 . Before the staples 30030 are deployed, the base 30031 of each staple 30030 can be supported by a staple driver 30040 ( FIG. 104 ) positioned within the rigid support portion 30010 of the staple cartridge 30000 . Additionally prior to deployment of the staples 30030, the legs 30032 of each staple 30030 can be at least partially contained within the staple cavity 30012 (FIG. 104).
任选地,如本文更详细地描述,钉30030可被部署在初始位置与击发位置之间。例如,钉击发滑动件30050可接合驱动器30040(图104)以使至少一个钉30030在初始位置与击发位置之间运动。主要参见图88,钉30030可运动至击发位置,其中钉30030的腿30032接合组织厚度补偿件32020的管状元件32080、穿透组织T并且接触与外科端部执行器12中的钉仓30000相对而定位的砧座30060(图104)。砧座30060中的钉成形凹坑30062可使钉腿30032弯曲,使得被击发钉30030捕获管状元件32080的一部分以及钉截留区域30039中的组织T的一部分。如本文更详细地描述,当钉30030在初始位置与击发位置之间运动时,至少一个钉腿30032可刺穿组织厚度补偿件32020的管状元件32080。作为另外一种选择,钉腿30032可围绕管状元件32080的周边运动,使得钉腿30032避免刺穿管状元件32080。与本文所述的紧固件类似,每个钉30030的腿30032可朝钉30030的基部30031向下变形以在两者间形成钉截留区域30039。钉截留区域30039可为其中组织T和组织厚度补偿件32020的一部分可由击发钉30030捕获的区域。在击发位置中,每个钉30030可向组织T以及被捕获在钉30030的钉截留区域30039内的组织厚度补偿件32020施加压缩力。Optionally, as described in greater detail herein, the staples 30030 can be deployed between the initial position and the fired position. For example, a staple firing sled 30050 can engage a driver 30040 (FIG. 104) to move at least one staple 30030 between an initial position and a fired position. Referring primarily to FIG. 88 , staples 30030 are movable to a fired position wherein legs 30032 of staples 30030 engage tubular elements 32080 of tissue thickness compensator 32020 , penetrate tissue T, and contact staple cartridge 30000 in surgical end effector 12 against Positioned anvil 30060 (FIG. 104). The staple forming pockets 30062 in the anvil 30060 can bend the staple legs 30032 such that the fired staples 30030 capture a portion of the tubular element 32080 and a portion of the tissue T in the staple entrapment region 30039 . As described in greater detail herein, at least one staple leg 30032 can pierce tubular element 32080 of tissue thickness compensator 32020 as staple 30030 is moved between an initial position and a fired position. Alternatively, the staple legs 30032 can be moved about the periphery of the tubular member 32080 such that the staple legs 30032 avoid piercing the tubular member 32080. Similar to the fasteners described herein, the legs 30032 of each staple 30030 are deformable downwardly toward the base 30031 of the staple 30030 to form a staple entrapment region 30039 therebetween. The staple entrapment region 30039 can be a region where the tissue T and a portion of the tissue thickness compensator 32020 can be captured by the fired staples 30030 . In the fired position, each staple 30030 can apply a compressive force to the tissue T and the tissue thickness compensator 32020 captured within the staple entrapment region 30039 of the staple 30030 .
仍参见图88,当管状元件32080被捕获在钉截留区域30039中时,管状元件32080的被捕获部分可变形,如本文所述。此外,管状元件32080可根据例如被捕获在该相同钉截留区域30039中的组织T的厚度、可压缩性和/或密度而变形至不同钉截留区域30039中的不同变形构型。组织厚度补偿件32080中的管状元件32080可纵向延伸穿过连续的钉截留区域30039。在此类构造中,管状元件32080可沿着一行击发钉30030变形至每个钉截留区域30039中的不同变形构型。现在参见图89,组织厚度补偿件33020中的管状元件33080可沿着一行击发钉30030侧向地布置在钉截留区域30039中。管状元件33080可由柔性外壳33210保持。在此类构造中,管状元件33080和柔性外壳33210可变形至每个钉截留区域30039中的不同变形构型。例如,在组织T较薄的情况下,管状元件33080可压缩得较少,并且在组织T较厚的情况下,管状元件33080可压缩得较多以适应较厚组织T。作为另外一种选择,管状元件33080的变形尺寸在组织厚度补偿件33020的整个长度和/或宽度范围内可为均一的。Still referring to FIG. 88, when the tubular element 32080 is captured in the staple entrapment region 30039, the captured portion of the tubular element 32080 can deform, as described herein. Furthermore, the tubular element 32080 can be deformed into different deformed configurations in different staple entrapment regions 30039 depending on, for example, the thickness, compressibility, and/or density of tissue T captured in that same staple entrapment region 30039 . The tubular element 32080 in the tissue thickness compensator 32080 can extend longitudinally through the continuous staple entrapment region 30039. In such configurations, the tubular element 32080 is deformable along a row of fired staples 30030 to a different deformed configuration in each staple entrapment region 30039 . Referring now to FIG. 89 , a tubular element 33080 in a tissue thickness compensator 33020 can be disposed laterally along a row of fired staples 30030 in a staple entrapment region 30039 . Tubular element 33080 may be retained by flexible housing 33210 . In such configurations, tubular element 33080 and flexible housing 33210 are deformable to different deformed configurations in each staple entrapment region 30039 . For example, where the tissue T is thinner, the tubular element 33080 can compress less, and where the tissue T is thicker, the tubular element 33080 can compress more to accommodate the thicker tissue T. Alternatively, the deformed dimension of the tubular element 33080 may be uniform throughout the length and/or width of the tissue thickness compensator 33020.
参见图90-图92,组织厚度补偿件34020中的管状元件34080可包括多个股线34090。主要参见图90,股线34090可被织造或编织到形成管状元件34080的管状晶格34092内。由股线34090形成的管状晶格34092可为基本上中空的。管状元件34080的股线34090可为实心股线、管状股线和/或另一种其他合适形状。例如,参见图91,管状晶格34092的单个股线34090可为管。参见图93,股线34090可包括延伸穿过其中的至少一个管腔34094。管腔34094的数量、几何形状和/或尺寸可确定股线34090的横截面形状。例如,股线34090可包括圆形管腔、半圆形管腔、楔形管腔和/或它们的组合。根据本发明,股线34090还可包括支撑纤维网34096,其可形成例如改性的“T”或“X”形状。至少股线34090的直径、延伸穿过其中的管腔和支撑纤维网可表征股线34090的横截面形状。如本文更详细地描述,每一股线34090的横截面形状可影响由股线34090产生的回弹力或恢复力以及由管状元件34080产生的对应回弹力或恢复力。Referring to FIGS. 90-92 , the tubular element 34080 in the tissue thickness compensator 34020 can comprise a plurality of strands 34090 . Referring primarily to FIG. 90 , strands 34090 may be woven or braided into tubular lattice 34092 forming tubular element 34080 . The tubular lattice 34092 formed from the strands 34090 can be substantially hollow. The strands 34090 of the tubular element 34080 can be solid strands, tubular strands, and/or another other suitable shape. For example, referring to FIG. 91 , the individual strands 34090 of the tubular lattice 34092 can be tubes. Referring to Fig. 93, the strand 34090 can include at least one lumen 34094 extending therethrough. The number, geometry and/or size of the lumens 34094 can determine the cross-sectional shape of the strands 34090. For example, the strands 34090 can include circular lumens, semi-circular lumens, wedge-shaped lumens, and/or combinations thereof. According to the present invention, the strand 34090 can also include a support web 34096, which can be formed into a modified "T" or "X" shape, for example. At least the diameter of the strand 34090, the lumen extending therethrough, and the supporting web can characterize the cross-sectional shape of the strand 34090. As described in greater detail herein, the cross-sectional shape of each strand 34090 can affect the resilient or restoring force produced by the strand 34090 and the corresponding resilient or restoring force produced by the tubular element 34080 .
参见图94,股线34090的管状晶格34092可为可变形的。管状晶格34092可产生或有助于管状元件34080的可变形性和/或回弹力。例如,管状晶格34092的股线34090可织造在一起,使得股线34090能够相对于彼此滑动和/或弯曲。当对管状元件34080的细长部分34082施加力时,其中的股线34090可滑动和/或弯曲,使得管状晶格34092运动至变形构型。例如,仍参见图94,钉30030可压缩管状晶格34092和被捕获在钉截留区域34039中的组织T,这可导致管状晶格34092的股线34090相对于彼此滑动和/或弯曲。当管状晶格34092被压缩至变形构型时,管状晶格34092的顶部顶点34086可朝管状晶格34092的底部顶点34088运动,以便适应钉截留区域30039中的被捕获组织T。在各种情况下,被捕获在击发钉30030中的管状晶格34092将试图重新获得其未变形构型并且可向被捕获的组织T施加恢复力。此外,定位在钉截留区域30039之间(即,未捕获在击发钉30030内)的管状晶格34092的部分还可由于钉截留区域30039内的管状晶格34092的相邻部分的变形而变形。在管状晶格34092变形的情况下,管状晶格34092可试图从变形构型回弹或部分地回弹。任选地,管状晶格34092的部分可回弹至其初始构型并且管状晶格34092的其他部分仅可部分地回弹和/或保持完全压缩。Referring to Fig. 94, the tubular lattice 34092 of the strands 34090 can be deformable. The tubular lattice 34092 can create or contribute to the deformability and/or resiliency of the tubular element 34080. For example, the strands 34090 of the tubular lattice 34092 can be woven together such that the strands 34090 can slide and/or bend relative to each other. When a force is applied to the elongate portion 34082 of the tubular member 34080, the strands 34090 therein can slide and/or bend, causing the tubular lattice 34092 to move into the deformed configuration. For example, still referring to FIG. 94, the staples 30030 can compress the tubular lattice 34092 and tissue T trapped in the staple entrapment regions 34039, which can cause the strands 34090 of the tubular lattice 34092 to slide and/or bend relative to each other. When the tubular lattice 34092 is compressed into the deformed configuration, the top apex 34086 of the tubular lattice 34092 can move towards the bottom apex 34088 of the tubular lattice 34092 in order to accommodate the captured tissue T in the staple entrapment region 30039 . Under various circumstances, the tubular lattice 34092 captured in the fired staple 30030 will attempt to regain its undeformed configuration and can apply a restorative force to the captured tissue T. Furthermore, portions of the tubular lattice 34092 positioned between the staple entrapment regions 30039 (ie, not trapped within the fired staples 30030 ) may also deform due to deformation of adjacent portions of the tubular lattice 34092 within the staple entrapment regions 30039 . Where tubular lattice 34092 is deformed, tubular lattice 34092 may attempt to spring back or partially spring back from the deformed configuration. Optionally, portions of the tubular lattice 34092 may rebound to their original configuration and other portions of the tubular lattice 34092 may only partially rebound and/or remain fully compressed.
与本文的管状元件的描述类似,每一股线34090还可为可变形的。此外,股线34090的变形可产生恢复力,该恢复力取决于每一股线34090的回弹力。主要参见图91和图92,管状晶格34092的每一股线34090可为管状。作为另外一种选择,管状晶格34092的每一股线34090可为实心。作为另外的另选形式,管状晶格30092可包括至少一个管状股线34090、至少一个实心股线34090、至少一个“X”或“T”形状股线34090和/或它们的组合。Similar to the description of the tubular elements herein, each strand 34090 may also be deformable. In addition, the deformation of the strands 34090 can create a restoring force that depends on the resilience of each strand 34090. Referring primarily to Figures 91 and 92, each strand 34090 of the tubular lattice 34092 can be tubular. Alternatively, each strand 34090 of the tubular lattice 34092 may be solid. As a further alternative, the tubular lattice 30092 may comprise at least one tubular strand 34090, at least one solid strand 34090, at least one "X" or "T" shaped strand 34090, and/or combinations thereof.
管状元件34080中的股线34090可包含聚合物组合物。股线34090的聚合物组合物可包含不可吸收的聚合物、可吸收的聚合物或它们的组合。合成聚合物的示例包括但不限于聚乙醇酸(PGA)、聚(乳酸)(PLA)、聚己内酯(PCL)、聚二氧杂环己酮(PDO)和它们的共聚物。例如,可吸收的聚合物可包括可生物吸收的生物相容性弹性体聚合物。此外,股线34090的聚合物组合物可包括合成聚合物、非合成聚合物和/或它们的组合。任选地,类似于本文在别处所述的聚合物组合物,股线34090的聚合物组合物可包括量不同(例如按重量百分比计)的可吸收的聚合物、不可吸收的聚合物、合成聚合物和/或非合成聚合物。The strands 34090 in the tubular member 34080 can comprise a polymer composition. The polymer composition of Strand 34090 may comprise non-absorbable polymers, absorbable polymers, or combinations thereof. Examples of synthetic polymers include, but are not limited to, polyglycolic acid (PGA), poly(lactic acid) (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. For example, absorbable polymers can include bioabsorbable biocompatible elastomeric polymers. Additionally, the polymer composition of strand 34090 can include synthetic polymers, non-synthetic polymers, and/or combinations thereof. Optionally, similar to the polymer compositions described elsewhere herein, the polymer composition of strand 34090 may include absorbable polymers, nonabsorbable polymers, synthetic polymers and/or non-synthetic polymers.
管状元件34080中的股线34090还可包含例如治疗剂34098(图91),诸如药物活性剂或药物。股线34090可释放治疗有效量的治疗剂34098。可在管状股线34090被吸收时释放治疗剂34098。例如,治疗剂30098可释放到流经股线34090之上或穿过股线34090的流体,诸如血液。作为另外的另选形式,例如当钉30030刺穿股线34090和/或当钉击发滑动件30050上的切割元件30052(图84)切割管状晶格34092的一部分时,可释放治疗剂34098。治疗剂34098的示例可包括但不限于止血剂和药物,诸如血纤维蛋白、凝血酶和/或氧化再生纤维素(ORC);抗炎药物,诸如双氯芬酸、阿司匹林、萘普生、舒林酸和/或氢化可的松;抗生素和抗微生物药物或制剂,诸如三氯生、离子银、氨苄青霉素、庆大霉素、多粘菌素B和/或氯霉素;抗癌剂,诸如顺铂、丝裂霉素和/或阿霉素;和/或生物制剂,诸如干细胞。The strands 34090 in the tubular member 34080 may also comprise, for example, a therapeutic agent 34098 (FIG. 91), such as a pharmaceutically active agent or drug. The strand 34090 can release a therapeutically effective amount of the therapeutic agent 34098. The therapeutic agent 34098 can be released as the tubular strand 34090 is absorbed. For example, the therapeutic agent 30098 can be released into fluid, such as blood, flowing over or through the strand 34090. As a further alternative, the therapeutic agent 34098 may be released, for example, when the staples 30030 pierce the strands 34090 and/or when the cutting elements 30052 ( FIG. 84 ) on the staple firing sled 30050 cut a portion of the tubular lattice 34092 . Examples of therapeutic agents 34098 may include, but are not limited to, hemostatic agents and drugs such as fibrin, thrombin, and/or oxidized regenerated cellulose (ORC); anti-inflammatory drugs such as diclofenac, aspirin, naproxen, sulindac, and and/or hydrocortisone; antibiotic and antimicrobial drugs or agents such as triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, and/or chloramphenicol; anticancer agents such as cisplatin , mitomycin, and/or doxorubicin; and/or biological agents, such as stem cells.
参见图95和图96,管状元件35080可包括股线35090的多个层35100。管状元件35080可包括管状晶格35092的多个层35100。参见图95,管状元件35080可包括例如股线35090的第一层35100a和第二层35100b。现在参见图96,组织厚度补偿件35120的管状元件35180可包括例如股线35090的第三层35100c。此外,管状元件35180中的不同层35100可包含不同材料。每个层35100a、35100b、35100c可为可生物吸收的,其中每个层35100a、35100b、35100c可包含不同的聚合物组合物。例如,第一层35100a可包括第一聚合物组合物;第二层35100b可包括第二聚合物组合物;并且第三层35100c可包括第三聚合物组合物。在此类情况下,管状元件35180的层35100a、35100b、35100c可按不同速率被生物吸收。例如,第一层35100a可快速吸收,第二层35100b可比第一层35100a更慢吸收,并且第三层35100c可比第一层35100a和/或第二层35100b更慢吸收。作为另外一种选择,第一层35100a可缓慢吸收,第二层35100b可比第一层35100a更快吸收,并且第三层35100c可比第一层35100a和/或第二层35100b更快吸收。Referring to FIGS. 95 and 96 , the tubular element 35080 can include multiple layers 35100 of strands 35090 . Tubular element 35080 may include multiple layers 35100 of tubular lattice 35092 . Referring to FIG. 95 , the tubular element 35080 can include a first layer 35100a and a second layer 35100b of strands 35090, for example. Referring now to FIG. 96 , the tubular element 35180 of the tissue thickness compensator 35120 can include a third layer 35100c such as strands 35090 . Additionally, different layers 35100 in tubular element 35180 may comprise different materials. Each layer 35100a, 35100b, 35100c can be bioabsorbable, wherein each layer 35100a, 35100b, 35100c can comprise a different polymer composition. For example, the first layer 35100a can include a first polymer composition; the second layer 35100b can include a second polymer composition; and the third layer 35100c can include a third polymer composition. In such cases, the layers 35100a, 35100b, 35100c of the tubular element 35180 may be bioabsorbed at different rates. For example, the first layer 35100a can absorb quickly, the second layer 35100b can absorb more slowly than the first layer 35100a, and the third layer 35100c can absorb more slowly than the first layer 35100a and/or the second layer 35100b. Alternatively, the first layer 35100a can absorb slowly, the second layer 35100b can absorb faster than the first layer 35100a, and the third layer 35100c can absorb faster than the first layer 35100a and/or the second layer 35100b.
与本文所述的股线34090类似,管状元件35180中的股线35090可包含药物35098。再次参见图95,为了控制药物35098的洗脱或释放,包含药物35098a的股线35090的第一层35100a可按第一速率被生物吸收,并且包含药物30098b的股线35090的第二层35100b可按第二速率被生物吸收。例如,第一层35100a可快速吸收以允许药物35098a快速初始释放,并且第二层35100b可较慢吸收以允许药物30098b受控释放。第一层30100a的股线35090中的药物35098a可不同于第二层35100b的股线35090中的药物35098b。例如,第一层35100a中的股线35090可包含氧化再生纤维素(ORC)并且第二层35100b中的股线35090可包含溶液,该溶液包含透明质酸。在此类情况下,第一层35100a的初始吸收可释放氧化再生纤维素以帮助控制出血,而第二层35100b的后续吸收可释放包含透明质酸的溶液以帮助抑制组织附着。作为另外一种选择,层35100a、35100b可包含相同药物35098a、35098b。例如,再次参见图96,层35100a、35100b和35100c中的股线35090可包含抗癌剂,诸如顺铂。此外,第一层35100a可快速吸收以允许顺铂快速初始释放,第二层35100b可较慢吸收以允许顺铂受控释放,并且第三层35100c可最慢吸收以允许顺铂的更延长的受控释放。Similar to the strands 34090 described herein, the strands 35090 in the tubular member 35180 can contain a drug 35098. Referring again to FIG. 95, in order to control the elution or release of the drug 35098, the first layer 35100a of the strands 35090 comprising the drug 35098a can be bioabsorbed at a first rate and the second layer 35100b of the strands 35090 comprising the drug 30098b can be bioabsorbed at a first rate. Bioabsorbed at the second rate. For example, the first layer 35100a can absorb quickly to allow for a quick initial release of the drug 35098a, and the second layer 35100b can absorb more slowly to allow for a controlled release of the drug 30098b. The drug 35098a in the strands 35090 of the first layer 30100a can be different than the drug 35098b in the strands 35090 of the second layer 35100b. For example, the strands 35090 in the first layer 35100a can comprise oxidized regenerated cellulose (ORC) and the strands 35090 in the second layer 35100b can comprise a solution comprising hyaluronic acid. In such cases, initial absorption of the first layer 35100a can release oxidized regenerated cellulose to help control bleeding, while subsequent absorption of the second layer 35100b can release a solution comprising hyaluronic acid to help inhibit tissue attachment. Alternatively, layers 35100a, 35100b may comprise the same drug 35098a, 35098b. For example, referring again to FIG. 96, strands 35090 in layers 35100a, 35100b, and 35100c may comprise an anti-cancer agent, such as cisplatin. In addition, the first layer 35100a can absorb quickly to allow for a quick initial release of cisplatin, the second layer 35100b can absorb more slowly to allow for a controlled release of cisplatin, and the third layer 35100c can absorb most slowly to allow for a more prolonged release of cisplatin. Controlled release.
参见图97和图98,组织厚度补偿件36020可包含重叠注塑材料36024。重叠注塑材料36024可形成于管状元件36080外侧、管状元件36080内侧或者管状元件36080内侧和外侧两者。参见图97,重叠注塑材料36024可同时在管状元件36080内侧和外侧共挤出,并且管状元件36080可包括股线36090的管状晶格36092。与本文所述的聚合物组合物类似,重叠注塑材料36024可包括例如聚乙醇酸(PGA)、聚(乳酸)(PLA)和/或任何其他合适的可生物吸收的生物相容性弹性体聚合物。此外,重叠注塑材料36024可为无孔的,使得重叠注塑材料36024形成管状元件36080中的流体不可透过的层。重叠注塑材料36024可限定穿过其中的管腔36084。Referring to FIGS. 97 and 98 , the tissue thickness compensator 36020 can comprise an overmolding material 36024 . The overmolding material 36024 can be formed on the outside of the tubular element 36080 , the inside of the tubular element 36080 , or both the inside and the outside of the tubular element 36080 . Referring to FIG. 97 , the overmolded material 36024 can be coextruded both inside and outside the tubular element 36080 , and the tubular element 36080 can include a tubular lattice 36092 of strands 36090 . Similar to the polymer compositions described herein, the overmolding material 36024 can include, for example, polyglycolic acid (PGA), poly(lactic acid) (PLA), and/or any other suitable bioabsorbable, biocompatible elastomeric polymer thing. Furthermore, the overmold material 36024 can be non-porous such that the overmold material 36024 forms a fluid impermeable layer in the tubular element 36080 . The overmolding material 36024 can define a lumen 36084 therethrough.
如上文进一步讨论,管状元件36080和/管状晶格36092中的股线36090可包含治疗剂36098。仍参见图97和图98,无孔重叠注塑材料36024可在内部管腔36084a内包含药物36098。作为另外一种选择或除此之外,无孔重叠注塑材料36024可在中间管腔36084b内包含药物36098,诸如包含含有药物的股线36090的管状晶格36092的中间管腔36084b。与上述类似,管状元件36080可相对于钉腔30012和钉仓30000中的切割元件30052而定位(图84)。钉30030的部署和/或切割元件30052的平移能够刺穿或使无孔重叠注塑材料36024破裂,使得可从管腔30084释放被容纳在管状元件30080的至少一个管腔36084中的药物36098。参见图99,管状元件37080可包括无孔膜37110。无孔膜37110可至少部分地围绕管状晶格37092或管状晶格30092的第一层37100a和第二层37100b以提供与本文所述的重叠注塑材料36024类似的流体不可透过的覆盖物。As discussed further above, the tubular elements 36080 and/or the strands 36090 in the tubular lattice 36092 can comprise a therapeutic agent 36098. Still referring to FIGS. 97 and 98, the non-porous overmold material 36024 can contain a drug 36098 within the interior lumen 36084a. Alternatively or in addition, the non-porous overmold material 36024 may contain the drug 36098 within the intermediate lumen 36084b, such as the intermediate lumen 36084b of the tubular lattice 36092 containing the drug-containing strands 36090. Similar to the above, the tubular member 36080 can be positioned relative to the staple cavity 30012 and the cutting member 30052 in the staple cartridge 30000 (FIG. 84). Deployment of the staples 30030 and/or translation of the cutting element 30052 can pierce or rupture the non-porous overmolding material 36024 such that the drug 36098 contained in at least one lumen 36084 of the tubular element 30080 can be released from the lumen 30084 . Referring to FIG. 99 , the tubular member 37080 can comprise a non-porous membrane 37110. The non-porous membrane 37110 can at least partially surround the tubular lattice 37092 or the first layer 37100a and the second layer 37100b of the tubular lattice 30092 to provide a fluid impermeable cover similar to the overmolding material 36024 described herein.
如本文所述,管状元件可包含可生物吸收的材料、治疗剂、多个股线、管状晶格、管状晶格的层、重叠注塑材料、无孔膜或其组合中的至少一者。例如,参见图100,管状元件38080可包含重叠注塑材料38024和穿过管状元件38080的中心管腔38084而定位的多个股线38090。股线38090可包含治疗剂38098。作为另外一种选择,例如,参见图101,管状元件39080可包含例如重叠注塑材料39024和定位在管状元件39080的中心管腔39084中的治疗剂39098。任选地,管状元件39080和重叠注塑材料39024中的至少一者可包含流体治疗剂39098。As described herein, the tubular element may comprise at least one of a bioabsorbable material, a therapeutic agent, a plurality of strands, a tubular lattice, layers of tubular lattices, an overmolded material, a non-porous film, or combinations thereof. For example, referring to FIG. 100 , a tubular element 38080 can comprise an overmolded material 38024 and a plurality of strands 38090 positioned through a central lumen 38084 of the tubular element 38080 . The strand 38090 can comprise a therapeutic agent 38098. Alternatively, see, eg, FIG. Optionally, at least one of the tubular element 39080 and the overmolding material 39024 can comprise a fluid therapeutic agent 39098.
主要再次参见图84,管状元件30080可相对于钉仓30000的刚性支撑部分30010而定位。管状元件30080可邻近刚性支撑部分30010纵向定位。管状元件30080可基本上平行于或与刚性支撑部分30010中的纵向狭槽或腔体30015对齐。管状元件30080可与纵向狭槽30015对齐,使得管状元件30080的一部分与纵向狭槽30015的一部分重叠。在此类情况下,钉击发滑动件30050上的切割元件30052可在切割刃30052沿着纵向狭槽30015平移时切断管状元件30080的一部分。作为另外一种选择,管状元件30080可纵向定位在纵向狭槽30015的第一侧或第二侧上。作为另外的另选形式,管状元件30080可相对于钉仓30000的刚性支撑部分30010而定位,使得管状元件30080侧向地或对角地横贯刚性支撑部分30010的至少一部分。Referring again primarily to FIG. 84 , tubular member 30080 can be positioned relative to rigid support portion 30010 of staple cartridge 30000 . Tubular element 30080 may be positioned longitudinally adjacent rigid support portion 30010 . The tubular element 30080 can be substantially parallel to or aligned with the longitudinal slot or cavity 30015 in the rigid support portion 30010 . The tubular element 30080 can be aligned with the longitudinal slot 30015 such that a portion of the tubular element 30080 overlaps a portion of the longitudinal slot 30015 . In such cases, the cutting element 30052 on the staple firing sled 30050 can sever a portion of the tubular element 30080 as the cutting edge 30052 translates along the longitudinal slot 30015 . Alternatively, the tubular member 30080 may be positioned longitudinally on either the first side or the second side of the longitudinal slot 30015 . As a further alternative, the tubular element 30080 can be positioned relative to the rigid support portion 30010 of the staple cartridge 30000 such that the tubular element 30080 laterally or diagonally traverses at least a portion of the rigid support portion 30010 .
参见例如图102,组织厚度补偿件40020可包括多个管状元件40080。管状元件40080可包含例如不同的长度、横截面形状和/或材料。此外,管状元件40080可相对于钉仓30000的刚性支撑部分40010而定位,使得管状元件40080的管状轴线彼此平行。管状元件40080的管状轴线可纵向对齐,使得第一管状元件40080被定位在另一个管状元件40080内。作为另外一种选择,平行管状元件40080可纵向地横贯例如钉仓30000。作为另外的另选形式,平行管状元件40080可侧向地或对角地横贯钉仓30000。作为另外一种选择,非平行管状元件40080可相对于彼此成角度取向,使得其管状轴线彼此相交和/或不平行。Referring to, eg, FIG. 102 , a tissue thickness compensator 40020 can include a plurality of tubular elements 40080 . Tubular element 40080 can comprise, for example, different lengths, cross-sectional shapes, and/or materials. Additionally, the tubular elements 40080 can be positioned relative to the rigid support portion 40010 of the staple cartridge 30000 such that the tubular axes of the tubular elements 40080 are parallel to each other. The tubular axes of the tubular elements 40080 can be longitudinally aligned such that a first tubular element 40080 is positioned within another tubular element 40080 . Alternatively, parallel tubular elements 40080 can longitudinally traverse, for example, staple cartridge 30000 . As a further alternative, the parallel tubular elements 40080 can traverse the staple cartridge 30000 laterally or diagonally. Alternatively, the non-parallel tubular elements 40080 may be oriented at an angle relative to each other such that their tubular axes intersect each other and/or are not parallel.
参见图102-图105,组织厚度补偿件40020可具有两个管状元件40080;第一管状元件40080a可纵向地定位在刚性支撑部分30010中的纵向狭槽30015的第一侧上,而第二管状元件40080b可纵向地定位在纵向狭槽30015的第二侧上。每个管状元件40080可包括股线40090的管状晶格40092。钉仓30000可包括总共六行钉腔30012,其中例如三行钉腔30012定位在纵向狭槽30015的每一侧上。在此类情况下,可能不需要平移钉击发滑动件30050上的切割刃30052切断管状元件40080的一部分。102-105, the tissue thickness compensator 40020 can have two tubular elements 40080; the first tubular element 40080a can be positioned longitudinally on a first side of the longitudinal slot 30015 in the rigid support portion 30010, while the second tubular Element 40080b can be positioned longitudinally on a second side of longitudinal slot 30015 . Each tubular element 40080 may comprise a tubular lattice 40092 of strands 40090 . The staple cartridge 30000 can include a total of six rows of staple cavities 30012 with, for example, three rows of staple cavities 30012 positioned on each side of the longitudinal slot 30015. In such cases, it may not be necessary to translate the cutting edge 30052 on the staple firing sled 30050 to sever a portion of the tubular element 40080 .
相似地,现在参见图106-图107,组织厚度补偿件41020可包括纵向布置在钉仓30000中的两个管状元件41080a、41080b。与上述类似,来自三行钉腔30012中的钉30030可接合一个管状元件41080a并且来自不同的三行钉腔30012中的钉30030可接合另一个管状元件41080b。仍参见图106-图107,被部署的钉30030可在横跨管状元件40080的横截面的不同位置处接合管状元件40080。如本文所述,由管状元件41080施加的回弹力弹性和对应恢复力可取决于管状元件41080的横截面形状等等。定位在位于管状元件41080的弧形部分处或附近的钉截留区域30039中的钉30030可比定位在非弧形部分附近的钉截留区域30039中的钉30030经受更大恢复力。相似地,定位在管状元件41080的非弧形部分中的钉截留区域30039中的钉30030可经受比由定位在管状元件30080的弧形部分处或附近的钉30030所体验的恢复力更小的恢复力。换句话讲,由于沿着此类部分的钉30030可能会捕获较大数量的弹性材料,管状元件41080的弧形部分可比管状元件41080的非弧形部分具有更大弹簧劲度系数。任选地,因此,主要参见图107,由组织厚度补偿件41020产生的恢复力可在管状元件30080a中的钉30030a和30030c附近更大并且在钉30030b附近更小。相应地,由组织厚度补偿件41020产生的恢复力可在管状元件30080b中的钉30030d和30030f附近比钉30030e附近更大。Similarly, referring now to FIGS. 106-107 , a tissue thickness compensator 41020 can include two tubular elements 41080 a , 41080 b disposed longitudinally within the staple cartridge 30000 . Similar to the above, staples 30030 from three rows of staple cavities 30012 can engage one tubular element 41080a and staples 30030 from a different three rows of staple cavities 30012 can engage another tubular element 41080b. Still referring to FIGS. 106-107 , the deployed staples 30030 can engage the tubular element 40080 at various locations across the cross-section of the tubular element 40080 . As described herein, the resilient force and corresponding restoring force exerted by the tubular element 41080 may depend on the cross-sectional shape of the tubular element 41080, among other things. Staples 30030 positioned in the staple entrapment region 30039 at or near the arcuate portion of the tubular element 41080 can experience greater restoring forces than staples 30030 positioned in the staple entrapment region 30039 near the non-arc portion. Similarly, a staple 30030 positioned in a staple entrapment region 30039 in a non-arcuate portion of the tubular element 41080 may experience less restoring force than experienced by a staple 30030 positioned at or near an arcuate portion of the tubular element 30080. Resilience. In other words, arcuate portions of tubular element 41080 may have a greater spring rate than non-arcuate portions of tubular element 41080 due to the likely capture of a greater amount of elastic material by the staples 30030 along such portions. Optionally, therefore, referring primarily to FIG. 107 , the restoring force produced by the tissue thickness compensator 41020 may be greater near the staples 30030a and 30030c in the tubular element 30080a and less near the staple 30030b. Accordingly, the restoring force generated by the tissue thickness compensator 41020 may be greater in the tubular element 30080b in the vicinity of the staples 30030d and 30030f than in the vicinity of the staple 30030e.
再次参见图102-图105,可选择包括管状晶格40092的股线40090的横截面几何形状,以便提供由管状晶格40092施加的所需回弹力弹性和对应恢复力。例如,再次参见图103,定位在管状元件40080的弧形部分中的股线40090a可包括X形状横截面,而定位在管状元件40080的非弧形部分中的股线40090b可包括管状横截面。包括不同横截面几何形状的股线40090a和40090b可织造在一起以形成管状晶格40092。作为另外一种选择,股线40090a和40090b可用例如粘合剂附接到彼此。参见图104和图105,管状元件40080中的股线40090的不同横截面几何形状可使横跨钉仓30000的钉截留区域30039中经受的恢复力最佳化。可选择特定横截面几何形状,使得横跨钉仓的钉截留区域30039中的回弹常数基本上平衡或相等。Referring again to FIGS. 102-105 , the cross-sectional geometry of the strands 40090 comprising the tubular lattice 40092 can be selected so as to provide the desired springback elasticity and corresponding restoring force exerted by the tubular lattice 40092 . For example, referring again to FIG. 103 , strands 40090a positioned in the arcuate portion of the tubular element 40080 can comprise an X-shaped cross-section, while strands 40090b positioned in the non-arcuate portion of the tubular element 40080 can comprise a tubular cross-section. Strands 40090a and 40090b comprising different cross-sectional geometries can be woven together to form tubular lattice 40092. Alternatively, strands 40090a and 40090b may be attached to each other with, for example, an adhesive. Referring to FIGS. 104 and 105 , different cross-sectional geometries of the strands 40090 in the tubular element 40080 can optimize the restoring forces experienced in the staple entrapment region 30039 across the staple cartridge 30000 . The particular cross-sectional geometry can be selected such that the spring constants in the staple entrapment region 30039 across the staple cartridge are substantially balanced or equal.
参见图108,组织厚度补偿件41120的管状元件41080a、41080b可通过邻接部分41126紧固在一起。尽管平移切割元件30052能够在管状元件41080a与41080b之间通过,但可能需要切割元件30052切断邻接部分41126的至少一部分。邻接部分41126可包含软性材料,诸如泡沫或凝胶,其容易被平移切割元件30052切断。邻接部分41026可将组织厚度补偿件41120可释放地固定到外科端部执行器12。邻接部分41126可固定到刚性支撑部分30010的顶部平台表面30011,使得在从外科端部执行器12释放管状元件41080a、41080b之后邻接部分41126仍保持在外科端部执行器12中。Referring to FIG. 108 , the tubular elements 41080 a , 41080 b of the tissue thickness compensator 41120 can be fastened together by abutment portions 41126 . While translating cutting element 30052 is able to pass between tubular elements 41080a and 41080b, it may be desirable for cutting element 30052 to sever at least a portion of adjoining portion 41126. The abutment portion 41126 may comprise a soft material, such as foam or gel, that is easily severed by the translating cutting element 30052 . The abutment portion 41026 can releasably secure the tissue thickness compensator 41120 to the surgical end effector 12 . The abutment portion 41126 can be secured to the top deck surface 30011 of the rigid support portion 30010 such that the abutment portion 41126 remains in the surgical end effector 12 after the tubular elements 41080a, 41080b are released from the surgical end effector 12 .
参见图109-图110,组织厚度补偿件42020可包括多个管状元件42080,使得例如管状元件42080的数量与钉仓30000中的钉腔30012的行数相同。钉仓30000可包括六行钉腔30012并且组织厚度补偿件42020可包括六个管状元件42080。每个管状元件42080可与一行钉腔30012基本上对齐。当钉30030被从一行钉腔30012射出时,来自该行的每个钉30030可刺穿相同管状元件42080(图110)。一个管42080的变形可对相邻管42080的变形具有极小的影响或没有影响。因此,管状元件42080可在横跨钉仓30030宽度的钉截留区域30039中施加基本上离散和定制的回弹力。在从多行钉腔30012击发的钉30030接合相同管状元件35080(图107)的情况下,管状元件35080的变形可较少定制。例如,管状元件35080在第一行中的钉截留区域30039中的变形可影响该管状元件35080在另一行中的钉截留区域30039中的变形。平移切割刃30052可避免切断管状元件42080。作为另外一种选择,参见图111,组织厚度补偿件43020可包括六个以上的管状元件43080,诸如七个管状元件44080。此外,管状元件43080可对称或非对称布置在端部执行器12中。当奇数个管状元件43080纵向并且对称布置在端部执行器12中时,平移切割元件30052能够切断覆盖在纵向通道30015上的中间管状元件。Referring to FIGS. 109-110 , the tissue thickness compensator 42020 can include a plurality of tubular elements 42080 such that, for example, the number of tubular elements 42080 is the same as the number of rows of staple cavities 30012 in the staple cartridge 30000 . The staple cartridge 30000 can include six rows of staple cavities 30012 and the tissue thickness compensator 42020 can include six tubular elements 42080 . Each tubular element 42080 can be substantially aligned with a row of staple cavities 30012 . When staples 30030 are fired from a row of staple cavities 30012, each staple 30030 from that row can pierce the same tubular element 42080 (FIG. 110). Deformation of one tube 42080 may have little or no effect on deformation of an adjacent tube 42080 . Accordingly, the tubular element 42080 can exert a substantially discrete and tailored resilient force in the staple entrapment region 30039 across the width of the staple cartridge 30030. Where staples 30030 fired from multiple rows of staple cavities 30012 engage the same tubular element 35080 ( FIG. 107 ), deformation of the tubular element 35080 can be less customized. For example, deformation of a tubular element 35080 in a staple entrapment region 30039 in a first row can affect deformation of that tubular element 35080 in a staple entrapment region 30039 in another row. Translating the cutting edge 30052 avoids severing the tubular element 42080. Alternatively, referring to FIG. 111 , the tissue thickness compensator 43020 may include more than six tubular elements 43080 , such as seven tubular elements 44080 . Additionally, the tubular element 43080 may be arranged symmetrically or asymmetrically within the end effector 12 . When an odd number of tubular elements 43080 are longitudinally and symmetrically arranged in the end effector 12, the translating cutting element 30052 is capable of severing the intermediate tubular elements overlying the longitudinal channel 30015.
参见图112,组织厚度补偿件44020可包括中心管状元件44080b,其至少部分地与钉仓30000的刚性支撑部分33010中的纵向狭槽30015对齐。组织厚度补偿件44020还可包括位于纵向狭槽30015一侧上的至少一个周边管状元件44080a、44080c。例如,组织厚度补偿件44020可包括三个管状元件44080:第一周边管状元件44080a可纵向定位在钉仓30000的纵向狭槽30015的第一侧上,中心管状元件44080b可基本上定位在纵向狭槽30015上方和/或与纵向狭槽30015对齐,并且第二周边管状元件44080c可纵向定位在纵向狭槽30015的第二侧上。中心管状元件44080b可包括相对于垂直直径为基本上伸长的水平直径。中心管状元件44080b和/或任何其他管状元件可与多行钉腔30012重叠。仍参见图112,例如,中心管状元件44080b可与钉腔30012的四个钉行重叠并且每个周边管状元件44080a、44080c可与单行钉腔30012重叠。作为另外一种选择,中心管状元件44080b可例如与少于四行钉腔30012重叠,例如,两行钉腔30012。此外,周边管状元件44080a、44080c可与不止一行钉腔30012重叠,诸如两行钉腔30012。现在参见图113,组织厚度补偿件44120的中心管状元件44180b可在中心管状元件44180b的管腔44184中包含治疗剂44198。任选地,中心管状元件44180b和/或至少一个周边管状元件44080a、44080c可包含治疗剂44198和/或任何其他合适的治疗剂。Referring to FIG. 112 , the tissue thickness compensator 44020 can include a central tubular member 44080b at least partially aligned with the longitudinal slot 30015 in the rigid support portion 33010 of the staple cartridge 30000 . The tissue thickness compensator 44020 may also include at least one peripheral tubular element 44080a, 44080c on one side of the longitudinal slot 30015. For example, the tissue thickness compensator 44020 can include three tubular elements 44080: a first peripheral tubular element 44080a can be positioned longitudinally on a first side of the longitudinal slot 30015 of the staple cartridge 30000, a central tubular element 44080b can be positioned substantially on the longitudinal slot The slot 30015 is above and/or aligned with the longitudinal slot 30015 and the second peripheral tubular element 44080c can be positioned longitudinally on a second side of the longitudinal slot 30015. The central tubular element 44080b can include a substantially elongated horizontal diameter relative to the vertical diameter. The central tubular element 44080b and/or any other tubular elements can overlap the rows of staple cavities 30012. Still referring to FIG. 112 , for example, the central tubular element 44080b can overlap four staple rows of staple cavities 30012 and each peripheral tubular element 44080a , 44080c can overlap a single row of staple cavities 30012 . Alternatively, the central tubular element 44080b can overlap, for example, less than four rows of staple cavities 30012 , eg, two rows of staple cavities 30012 . Additionally, the peripheral tubular elements 44080a, 44080c may overlap more than one row of staple cavities 30012, such as two rows of staple cavities 30012. Referring now to FIG. 113, the central tubular element 44180b of the tissue thickness compensator 44120 can contain a therapeutic agent 44198 within the lumen 44184 of the central tubular element 44180b. Optionally, the central tubular element 44180b and/or at least one peripheral tubular element 44080a, 44080c may comprise a therapeutic agent 44198 and/or any other suitable therapeutic agent.
参见图114,组织厚度补偿件44220可包括外壳44224,该外壳可与本文所述的重叠注塑材料32024类似。外壳44224将多个管状元件44080在端部执行器12中保持就位。外壳44224可与管状元件44080共挤出。管状元件44080可包括股线44090的管状晶格44092。类似于本文在别处所述的聚合物组合物,外壳44224可例如包含聚乙醇酸(PGA)、聚(乳酸)(PLA)和/或任何其他合适的可生物吸收的生物相容性弹性体聚合物。此外,外壳44224可为无孔的,使得外壳44224例如在组织厚度补偿件44220内形成流体不可透过的层。如本文进一步讨论,管状元件44080和/或管状晶格44092中的股线44090可包含治疗剂44098。无孔的外壳44224可在组织厚度补偿件内包含治疗剂44098。如本文所述,管状元件44080可相对于钉腔30012和切割元件30052被定位在钉仓30000内。钉30030的部署和/或切割元件30052的平移能够刺穿无孔的外壳44224或使其破裂,使得其中包含的治疗剂44198可从组织厚度补偿件44020中释放。Referring to Fig. 114, a tissue thickness compensator 44220 can include a housing 44224, which can be similar to the overmolding material 32024 described herein. Housing 44224 holds plurality of tubular elements 44080 in place within end effector 12 . Housing 44224 may be co-extruded with tubular member 44080. The tubular element 44080 may comprise a tubular lattice 44092 of strands 44090 . Similar to the polymer compositions described elsewhere herein, the shell 44224 may, for example, comprise polyglycolic acid (PGA), poly(lactic acid) (PLA), and/or any other suitable bioabsorbable, biocompatible elastomeric polymer things. Additionally, the housing 44224 can be non-porous such that the housing 44224 forms a fluid-impermeable layer within the tissue thickness compensator 44220, for example. As discussed further herein, the tubular elements 44080 and/or the strands 44090 in the tubular lattice 44092 can comprise a therapeutic agent 44098. The non-porous housing 44224 can contain a therapeutic agent 44098 within the tissue thickness compensator. Tubular element 44080 can be positioned within staple cartridge 30000 relative to staple cavity 30012 and cutting element 30052 as described herein. Deployment of staples 30030 and/or translation of cutting elements 30052 can pierce or rupture non-porous housing 44224 such that therapeutic agent 44198 contained therein can be released from tissue thickness compensator 44020.
参见图115,组织厚度补偿件44320可包括中心管状元件44380b,该中心管状元件包括管状晶格44392。管状晶格44392可具有非织造部分或间隙44381,所述非织造部分或间隙基本上与刚性支撑部分30010的纵向狭槽30015对齐。在这种情况下,管状元件44380b的管状晶格44092的织造部分不与纵向狭槽30015重叠。因此,平移钉击发滑动件30052上的切割元件30052可沿纵向狭槽30015平移而不切断管状晶格44392的织造部分的重叠。虽然邻近管状元件44380b中的间隙44381定位的钉30030c和30030d可从管状晶格44392结构接收较少的支撑,但另外的特征结构可为这些钉30030提供支撑和/或在其钉截留区域30039中提供另外的恢复力。例如,如本文更详细地描述,另外的管状元件、支撑带、弹簧和/或支柱材料可例如被定位在间隙44381附近的内部和外部管状元件44380b中的至少一者处。Referring to FIG. 115 , a tissue thickness compensator 44320 can include a central tubular element 44380b that includes a tubular lattice 44392 . Tubular lattice 44392 may have nonwoven portions or gaps 44381 that are substantially aligned with longitudinal slots 30015 of rigid support portion 30010 . In this case, the woven portion of the tubular lattice 44092 of the tubular element 44380b does not overlap the longitudinal slot 30015 . Thus, the cutting element 30052 on the translating staple firing sled 30052 can translate along the longitudinal slot 30015 without severing the overlap of the woven portion of the tubular lattice 44392. While the staples 30030c and 30030d positioned adjacent to the gap 44381 in the tubular element 44380b may receive less support from the tubular lattice 44392 structure, additional features may provide support for these staples 30030 and/or in their staple entrapment regions 30039 Provides additional resilience. For example, additional tubular elements, support straps, springs, and/or strut material may be positioned, for example, at at least one of the inner and outer tubular elements 44380b proximate gap 44381, as described in greater detail herein.
现在参见图116-图119,组织厚度补偿件45020可包括侧向地横贯钉仓30000的多个管状元件45080。管状元件45080可被定位成垂直于钉腔30012的行和/或钉仓30000的刚性支撑部分30010的纵向轴线。参见图116,管状元件45080可以横贯钉仓30000中的纵向狭槽30015,使得钉击发滑动件30050上的切割元件30052能够在钉击发滑动件30050沿纵向狭槽30015平移时切断管状元件45080。作为另外一种选择,现在参见图117,组织厚度补偿件46020可包括两组侧向地横贯的管状元件46080。第一组侧向地横贯的管状元件46080a可定位在纵向狭槽30015的第一侧上,第二组侧向地横贯的管状元件46080b可定位在纵向狭槽30015的第二侧上。在此类构造中,切割元件30052能够在两组管状元件46080之间穿过,而不切断管状元件46080的一部分。作为另外一种选择,当至少一个其他管状元件46080并未横贯纵向狭槽30015并且未被切割元件30052切断时,切割元件30052可以切断横贯纵向狭槽30015的至少一个管状元件46080。Referring now to FIGS. 116-119 , a tissue thickness compensator 45020 can comprise a plurality of tubular elements 45080 that laterally traverse the staple cartridge 30000 . The tubular elements 45080 can be positioned perpendicular to the rows of staple cavities 30012 and/or the longitudinal axis of the rigid support portion 30010 of the staple cartridge 30000. 116, the tubular element 45080 can traverse the longitudinal slot 30015 in the staple cartridge 30000 such that the cutting element 30052 on the staple firing sled 30050 can sever the tubular element 45080 as the staple firing sled 30050 translates along the longitudinal slot 30015. Alternatively, referring now to FIG. 117 , the tissue thickness compensator 46020 may comprise two sets of laterally traversing tubular elements 46080 . A first set of laterally traversing tubular elements 46080a can be positioned on a first side of the longitudinal slot 30015 and a second set of laterally traversing tubular elements 46080b can be positioned on a second side of the longitudinal slot 30015 . In such configurations, the cutting element 30052 can be passed between the two sets of tubular elements 46080 without severing a portion of the tubular elements 46080 . Alternatively, cutting element 30052 may sever at least one tubular element 46080 traversing longitudinal slot 30015 when at least one other tubular element 46080 does not traverse longitudinal slot 30015 and is not severed by cutting element 30052 .
当管状元件45080侧向地横贯钉仓30000时,参见图118和图119,钉30030可接合每个钉截留区域30039中的至少一个管状元件45080。在此类构造中,每个管状元件45080可沿钉仓30000的长度提供离散的恢复力。例如,主要参见图119,与在组织更薄处的组织厚度补偿件45020的远侧末端附近定位的管状元件45080相比,在组织更厚处的组织厚度补偿件45020的近侧末端附近定位的管状元件45080可被极大地压缩。因此,与可由更靠近组织厚度补偿件45020的远侧末端定位的管状元件46080产生的恢复力相比,更靠近组织厚度补偿件45020的近侧末端定位的管状元件45080可提供更大的恢复力。此外,仍参见图119,一个管45080的变形对于相邻管45080的变形可具有极小的影响或没有影响。因此,管状元件45080可在沿钉仓30030的长度的钉截留区域30039中施加基本上离散和定制的回弹力。在从单行钉腔30012中击发的多个钉30030接合相同管状元件35080的情况下,管状元件35080的变形可较少定制。例如,一个钉截留区域30039中的管状元件35080的变形可影响该管状元件35080在另一个钉截留区域30039中的变形。As the tubular elements 45080 laterally traverse the staple cartridge 30000, see FIGS. In such configurations, each tubular element 45080 can provide a discrete restoring force along the length of the staple cartridge 30000. For example, referring primarily to FIG. 119 , a tubular element 45080 positioned near the proximal end of the tissue thickness compensator 45020 where the tissue is thicker compared to a tubular element 45080 positioned near the distal end of the tissue thickness compensator 45020 where the tissue is thinner The tubular element 45080 can be greatly compressed. Accordingly, the tubular element 45080 positioned closer to the proximal end of the tissue thickness compensator 45020 can provide a greater restoring force than can be produced by the tubular element 46080 positioned closer to the distal end of the tissue thickness compensator 45020 . Furthermore, still referring to FIG. 119 , the deformation of one tube 45080 may have little or no effect on the deformation of an adjacent tube 45080 . Accordingly, the tubular element 45080 can exert a substantially discrete and tailored resilient force in the staple entrapment region 30039 along the length of the staple cartridge 30030. Where multiple staples 30030 fired from a single row of staple cavities 30012 engage the same tubular element 35080, deformation of the tubular element 35080 can be less customized. For example, deformation of a tubular element 35080 in one staple entrapment region 30039 can affect deformation of the tubular element 35080 in another staple entrapment region 30039 .
作为另外的另选形式,参见图120-图125,组织厚度补偿件47020的管状元件47080可对角地横贯钉仓30000。管状元件47080可以横贯钉仓30000中的纵向狭槽30015,使得钉击发滑动件30050上的切割元件30052能够在钉击发滑动件30052沿纵向狭槽30015平移时切断对角地横贯的管状元件47080。作为另外一种选择,组织厚度补偿件47020可包括两组对角地横贯的管状元件47080。第一组对角地横贯的管状元件47080可定位在纵向狭槽30015的第一侧上,第二组对角地横贯的管状元件47080可定位在纵向狭槽30015的第二侧上。在此类构造中,切割元件30052可在两组管状元件47080之间穿过,并且可以不切断任何管状元件47080。As a further alternative, referring to FIGS. 120-125 , the tubular element 47080 of the tissue thickness compensator 47020 can traverse the staple cartridge 30000 diagonally. The tubular elements 47080 can traverse the longitudinal slots 30015 in the staple cartridge 30000 such that the cutting elements 30052 on the staple firing sled 30050 can sever the diagonally traversing tubular elements 47080 as the staple firing sleds 30052 translate along the longitudinal slots 30015. Alternatively, the tissue thickness compensator 47020 may comprise two sets of tubular elements 47080 that traverse diagonally. A first set of diagonally traversing tubular elements 47080 can be positioned on a first side of the longitudinal slot 30015 and a second set of diagonally traversing tubular elements 47080 can be positioned on a second side of the longitudinal slot 30015 . In such configurations, the cutting element 30052 can be passed between the two sets of tubular elements 47080 and none of the tubular elements 47080 can be severed.
仍然参见图120-图123,对角地横贯的管状元件47080可以定位在钉仓30000内,使得间隙限定在管状元件47080之间。当诸如通过在成形钉30030的钉截留区域30039内捕获的组织T向相邻管状元件47080施加压缩力时,相邻管状元件之间的间隙可为管状元件47080的水平膨胀提供空间。管状元件47080可通过材料膜或材料片47024横跨间隙连接。材料片可定位在刚性支撑部分30010的平台表面30011和/或管状元件47080的组织接触侧中的至少一者上。Still referring to FIGS. 120-123 , the diagonally traversing tubular elements 47080 can be positioned within the staple cartridge 30000 such that a gap is defined between the tubular elements 47080 . The gap between adjacent tubular elements 47080 may provide room for horizontal expansion of tubular elements 47080 when a compressive force is applied to adjacent tubular elements 47080 , such as by tissue T captured within staple entrapment regions 30039 of formed staples 30030 . The tubular element 47080 may be connected across the gap by a film or sheet of material 47024 . The sheet of material can be positioned on at least one of the deck surface 30011 of the rigid support portion 30010 and/or the tissue contacting side of the tubular element 47080 .
参见图124和图125,至少一个对角地横贯的管状元件47080可相对于钉腔30012定位在钉仓30000内,使得管状元件47080定位在从多行钉腔30012部署的钉30030的腿30032之间。当钉30030从初始位置运动到击发位置时,如本文更详细地描述,钉腿30032可保持定位在管状元件47080周围。此外,例如,钉可以变形,使得钉腿30032围绕管状元件47080的周边包裹。在此类构造中,钉30030能够运动到击发或成形位置,而不刺穿管状元件47080。钉腿30032围绕管状元件47080的运动可防止无意地释放保持在其中的治疗剂47098。每个管状元件47080相对于钉仓30000的纵向狭槽30015的所选择的角取向可取决于钉腔30012在钉仓30000中的位置。例如,管状元件47080可相对于钉仓30000的纵向狭槽30015成约四十五(45)度角定位。作为另外一种选择,管状元件47080可例如相对于钉仓30000的纵向狭槽30015成十五(15)至七十五(75)度角定位。124 and 125 , at least one diagonally traversing tubular element 47080 can be positioned within staple cartridge 30000 relative to staple cavities 30012 such that tubular element 47080 is positioned between legs 30032 of staples 30030 deployed from rows of staple cavities 30012 . As the staples 30030 are moved from the initial position to the fired position, as described in greater detail herein, the staple legs 30032 can remain positioned about the tubular member 47080. Also, for example, the staples can be deformed such that the staple legs 30032 wrap around the perimeter of the tubular member 47080. In such configurations, the staples 30030 can be moved to the fired or formed position without piercing the tubular element 47080. Movement of the staple legs 30032 about the tubular member 47080 prevents inadvertent release of the therapeutic agent 47098 held therein. The selected angular orientation of each tubular element 47080 relative to the longitudinal slot 30015 of the staple cartridge 30000 can depend on the position of the staple cavity 30012 within the staple cartridge 30000 . For example, tubular element 47080 can be positioned at an angle of about forty-five (45) degrees relative to longitudinal slot 30015 of staple cartridge 30000 . Alternatively, the tubular element 47080 can be positioned at an angle of fifteen (15) to seventy-five (75) degrees relative to the longitudinal slot 30015 of the staple cartridge 30000, for example.
类似于本公开通篇的描述,组织厚度补偿件中的多个管状元件可通过例如粘合剂、包裹物、带材、重叠注塑材料、补偿材料和/或任何其他合适的连接粘合剂或结构来连接。参见图126-图128,柔性外壳48024可围绕或封装组织厚度补偿件48020中的管状元件48080。柔性外壳48024可限制端部执行器12中的管状元件48080,并且可使每个管状元件48080保持就位,诸如与一行钉腔30012纵向对齐。例如,组织厚度补偿件48020可包括六个管状元件48080。柔性外壳48024可为充分可变形的和有弹性的,以限制其中包裹的管状元件48020,同时允许管状元件48080的变形和回弹。此外,柔性外壳48024可绷紧地围绕管状元件48080,并且可在管状元件48080变形和/或回弹时保持与管状元件的绷紧接合。Similar to that described throughout this disclosure, the plurality of tubular elements in a tissue thickness compensator may be joined by, for example, adhesives, wraps, tapes, overmolded materials, compensating materials, and/or any other suitable adhesive or structure to connect. Referring to FIGS. 126-128 , a flexible shell 48024 can surround or encapsulate a tubular element 48080 in a tissue thickness compensator 48020 . The flexible housing 48024 can confine the tubular elements 48080 in the end effector 12 and can hold each tubular element 48080 in place, such as longitudinally aligned with a row of staple cavities 30012 . For example, tissue thickness compensator 48020 can include six tubular elements 48080 . The flexible shell 48024 may be sufficiently deformable and resilient to constrain the tubular element 48020 encased therein while allowing deformation and springback of the tubular element 48080. In addition, the flexible shell 48024 can fit tautly around the tubular member 48080 and can remain in taut engagement with the tubular member 48080 as the tubular member 48080 deforms and/or springs back.
参见图127,在部署钉30030之前,砧座30060可向下枢转或旋转,以压缩砧座30060和钉仓30000之间的组织厚度补偿件48020和组织T。组织厚度补偿件48020的压缩可包括柔性外壳48024和其中管状元件48020的对应压缩。当管状元件48020变形时,柔性外壳48024可相似地变形。管状元件48020可在钉仓30000的整个宽度上均匀地压缩,并且柔性外壳48024可经历在整个管状元件48080上的相似均匀压缩。参见图128,当砧座30060在已从钉仓30000部署钉30030之后打开时,管状元件48080可从压缩构型回弹或部分地回弹(图127)。根据本发明,管状元件48080可以回弹,使得管状元件48080返回到其初始未变形构型。管状元件48080可以部分地回弹,使得管状元件48080部分地返回到其初始未变形构型。例如,管状元件48080的变形可为部分弹性和部分塑性的。当管状元件48080回弹时,柔性外壳48024可保持与每个管状元件48080绷紧接合。管状元件48080和柔性外壳48024可以回弹至这样的程度,所述程度使管状元件48080和组织T填充钉截留区域30039,同时管状元件48080在其中的组织T上施加适当的恢复力。参见图129,在其他情况下,包括六个保持在柔性外壳48124中的管状元件48180的组织厚度补偿件48120可例如被定位在端部执行器12的砧座30060上。Referring to FIG. 127 , prior to deployment of staples 30030 , anvil 30060 can be pivoted or rotated downward to compress tissue thickness compensator 48020 and tissue T between anvil 30060 and staple cartridge 30000 . Compression of the tissue thickness compensator 48020 can include corresponding compression of the flexible shell 48024 and the tubular element 48020 therein. When the tubular element 48020 is deformed, the flexible shell 48024 can be similarly deformed. Tubular element 48020 can compress uniformly across the width of staple cartridge 30000 , and flexible housing 48024 can experience similar uniform compression across tubular element 48080 . 128, when the anvil 30060 is opened after the staples 30030 have been deployed from the staple cartridge 30000, the tubular elements 48080 can rebound or partially rebound from the compressed configuration (FIG. 127). In accordance with the present invention, the tubular element 48080 can spring back such that the tubular element 48080 returns to its original, undeformed configuration. The tubular element 48080 can partially spring back such that the tubular element 48080 partially returns to its original, undeformed configuration. For example, the deformation of the tubular element 48080 can be partially elastic and partially plastic. The flexible shell 48024 can remain in taut engagement with each tubular element 48080 as the tubular element 48080 springs back. The tubular element 48080 and flexible housing 48024 can rebound to an extent that the tubular element 48080 and tissue T fill the staple entrapment area 30039 while the tubular element 48080 exerts an appropriate restoring force on the tissue T therein. Referring to FIG. 129 , in other cases, a tissue thickness compensator 48120 comprising six tubular elements 48180 held in a flexible housing 48124 can be positioned on an anvil 30060 of an end effector 12 , for example.
参见图130-图133,组织厚度补偿件49020可包括管状元件49080,该管状元件沿砧座30060的纵向轴线纵向定位。组织厚度补偿件49020可通过可压缩的补偿材料49024被固定到端部执行器12的砧座30060。此外,可压缩的补偿材料49024可以围绕或封装管状元件49080。类似于本文的描述,管状元件49080可包括至少一种治疗剂49098,该治疗剂可通过以下方式释放:吸收组织厚度补偿件49020的各种组分、通过由钉仓30000击发的钉30030和/或切割元件30052刺穿管状元件49080。Referring to FIGS. 130-133 , the tissue thickness compensator 49020 can include a tubular member 49080 positioned longitudinally along the longitudinal axis of the anvil 30060 . The tissue thickness compensator 49020 can be secured to the anvil 30060 of the end effector 12 by a compressible compensating material 49024 . Additionally, a compressible compensating material 49024 may surround or encapsulate the tubular element 49080. Similar to that described herein, the tubular element 49080 can include at least one therapeutic agent 49098 that can be released by absorbing various components of the tissue thickness compensator 49020, by the staples 30030 fired by the staple cartridge 30000, and/or Or cutting element 30052 pierces tubular element 49080.
参见图131,钉仓30000可包括定位在钉腔30012中的钉30030,其中在部署钉30030之前,砧座30060和附接于其上的组织厚度补偿件49020可以朝钉仓30000枢转并且压缩捕获在两者间的组织T。组织厚度补偿件49020的管状元件49080可通过枢转砧座30060沿钉仓30000的长度均匀地变形(图131)。参见图132和图133,钉击发滑动件30050可沿钉仓30000中的纵向狭槽30015平移并且接合定位在钉腔30010中的钉30030下方的每个驱动器30040,其中每个接合的驱动器30040可从钉腔30012中击发或射出钉30030。当砧座30060释放组织T和组织厚度补偿件49020上的压力时,组织厚度补偿件49020(包括管状元件49080和可压缩的补偿材料49024)可从压缩构型(图131)回弹或部分地回弹至回弹构型(图132和图133)。管状元件49080和可压缩的补偿材料49024可回弹至这样的程度,所述程度使组织厚度补偿件49020和组织T填充钉截留区域30039,同时组织厚度补偿件49020将恢复力施加在被捕获的组织T上。131 , staple cartridge 30000 can include staples 30030 positioned in staple cavities 30012, wherein prior to deployment of staples 30030, anvil 30060 and tissue thickness compensator 49020 attached thereto can be pivoted toward staple cartridge 30000 and compressed Capture the tissue T in between. Tubular member 49080 of tissue thickness compensator 49020 can be deformed uniformly along the length of staple cartridge 30000 by pivoting anvil 30060 (FIG. 131). 132 and 133 , staple firing sled 30050 can translate along longitudinal slot 30015 in staple cartridge 30000 and engage each driver 30040 positioned below staple 30030 in staple cavity 30010 , wherein each engaged driver 30040 can The staples 30030 are fired or ejected from the staple cavities 30012. When the anvil 30060 releases the pressure on the tissue T and the tissue thickness compensator 49020, the tissue thickness compensator 49020 (comprising the tubular element 49080 and the compressible compensating material 49024) can rebound or partially Rebound to the rebound configuration (FIGS. 132 and 133). Tubular element 49080 and compressible compensating material 49024 can rebound to such an extent that tissue thickness compensator 49020 and tissue T fill staple entrapment region 30039 while tissue thickness compensator 49020 applies a restoring force to the captured Organization T.
参见图124-图126,两个组织厚度补偿件50020a、50020b可被定位在外科器械的端部执行器12中。例如,第一组织厚度补偿件50020a可以附接到下钳口30070中的钉仓30000,并且第二组织厚度补偿件50020b可以附接到砧座30060。第一组织厚度补偿件50020a可包括多个管状元件50080,该多个管状元件被纵向地布置和保持在第一补偿材料50024a中。至少一个管状元件50080可包含治疗剂50098,类似于本文所述的治疗剂。第一补偿材料50024a可为可变形的或大体刚性的。此外,第一补偿材料50024a可使管状元件50080相对于钉通道30000保持就位。例如,第一补偿材料50024a可使每个管状元件50080保持与一行钉腔30012纵向对齐。第二组织厚度补偿件50020b可包含第一补偿材料50024a、第二补偿材料50024b和/或第三补偿材料50024c。第二补偿材料50024b和第三补偿材料50024c可为可变形的或大体刚性的。124-126, two tissue thickness compensators 50020a, 50020b can be positioned in the end effector 12 of the surgical instrument. For example, a first tissue thickness compensator 50020a can be attached to the staple cartridge 30000 in the lower jaw 30070 and a second tissue thickness compensator 50020b can be attached to the anvil 30060. The first tissue thickness compensator 50020a can include a plurality of tubular elements 50080 longitudinally arranged and retained within the first compensating material 50024a. At least one tubular element 50080 can contain a therapeutic agent 50098, similar to the therapeutic agents described herein. The first compensating material 50024a can be deformable or substantially rigid. Additionally, the first compensating material 50024a can hold the tubular member 50080 in place relative to the staple channel 30000. For example, the first compensating material 50024a can maintain each tubular element 50080 in longitudinal alignment with the row of staple cavities 30012 . The second tissue thickness compensator 50020b can comprise a first compensating material 50024a, a second compensating material 50024b, and/or a third compensating material 50024c. The second compensation material 50024b and the third compensation material 50024c may be deformable or substantially rigid.
砧座30060可以枢转并且将压缩力施加到组织厚度补偿件50020a、50020b和砧座30060与钉仓30000之间的组织T。在一些情况下,第一组织厚度补偿件50020a和第二组织厚度补偿件50020b均不是可压缩的。作为另外一种选择,第一组织厚度补偿件50020a和/或第二组织厚度补偿件50020b中的至少一个组件可为可压缩的。现在参见图135和图136,当钉30030从钉仓30000中被击发时,每个钉30030可以刺穿保持在第一组织厚度补偿件50020a中的管状元件50080。如图135所示,保持在管状元件50080中的治疗剂50098可在钉30030刺穿管状元件50080时释放。在释放时,治疗剂50098可以涂覆钉腿30032和围绕击发钉30030的组织T。当钉30030从钉仓30000中被击发时,钉30030也可刺穿第二组织厚度补偿件50020b。Anvil 30060 can pivot and apply a compressive force to tissue thickness compensator 50020a, 50020b and tissue T between anvil 30060 and staple cartridge 30000. In some cases, neither the first tissue thickness compensator 50020a nor the second tissue thickness compensator 50020b is compressible. Alternatively, at least one component of the first tissue thickness compensator 50020a and/or the second tissue thickness compensator 50020b can be compressible. Referring now to FIGS. 135 and 136, when the staples 30030 are fired from the staple cartridge 30000, each staple 30030 can pierce the tubular element 50080 retained in the first tissue thickness compensator 50020a. As shown in FIG. 135 , the therapeutic agent 50098 retained in the tubular element 50080 can be released when the staple 30030 pierces the tubular element 50080 . Upon release, the therapeutic agent 50098 can coat the staple legs 30032 and the tissue T surrounding the fired staples 30030. When the staples 30030 are fired from the staple cartridge 30000, the staples 30030 can also pierce the second tissue thickness compensator 50020b.
参见图137-图140,组织厚度补偿件51020可包括侧向地横贯组织厚度补偿件51020的至少一个管状元件51080。例如,参见图137,组织厚度补偿件51020可相对于钉仓30000定位,使得侧向地横贯的管状元件51080的第一末端51083可被定位在钉仓30000的第一纵向侧附近,并且侧向地横贯的管状元件51080的第二末端51085可被定位在钉仓30000的第二纵向侧附近。例如,管状元件51080可包括胶囊状形状。如图138所示,管状元件51080可在第一末端51083和第二末端51085之间被穿孔,并且在一些情况下,管状元件51080可在管状元件51080的中心51087处或附近被穿孔。例如,管状元件51080可包含聚合物组合物,诸如可生物吸收的生物相容性弹性体聚合物。此外,再次参见图137,组织厚度补偿件51020可包括多个侧向地横贯的管状元件51080。例如,十三个管状元件51080可被侧向地布置在组织厚度补偿件51020中。Referring to FIGS. 137-140 , the tissue thickness compensator 51020 can include at least one tubular element 51080 laterally traversing the tissue thickness compensator 51020 . For example, referring to FIG. 137 , the tissue thickness compensator 51020 can be positioned relative to the staple cartridge 30000 such that the first end 51083 of the laterally traversing tubular member 51080 can be positioned near the first longitudinal side of the staple cartridge 30000 and laterally The second end 51085 of the transverse tubular element 51080 can be positioned adjacent the second longitudinal side of the staple cartridge 30000. For example, tubular element 51080 can comprise a capsule-like shape. As shown in FIG. 138 , tubular element 51080 can be perforated between first end 51083 and second end 51085 , and in some cases, tubular element 51080 can be perforated at or near center 51087 of tubular element 51080 . For example, tubular element 51080 may comprise a polymer composition, such as a bioabsorbable biocompatible elastomeric polymer. In addition, referring again to FIG. 137 , the tissue thickness compensator 51020 can include a plurality of laterally traversing tubular elements 51080 . For example, thirteen tubular elements 51080 can be disposed laterally within tissue thickness compensator 51020 .
再次参见图137,组织厚度补偿件51020还可包括至少部分地围绕管状元件51080的补偿材料51024。补偿材料51024可包含可生物吸收的聚合物,诸如冻干多糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和/或氧化再生纤维素(ORC)。补偿材料51024可使管状元件51080在组织厚度补偿件51020中保持就位。此外,补偿材料51024可被固定到钉仓30000的刚性支撑部分30010的顶部平台表面30011,使得补偿材料51020牢固地定位在端部执行器12中。补偿材料51024可包含至少一种药物51098。Referring again to FIG. 137 , the tissue thickness compensator 51020 can also include a compensating material 51024 at least partially surrounding the tubular element 51080 . The compensation material 51024 may comprise bioabsorbable polymers such as lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and/or oxidized regenerated cellulose (ORC). The compensating material 51024 can hold the tubular element 51080 in place within the tissue thickness compensator 51020 . Additionally, compensating material 51024 can be secured to top deck surface 30011 of rigid support portion 30010 of staple cartridge 30000 such that compensating material 51020 is securely positioned within end effector 12 . Compensation material 51024 can comprise at least one drug 51098.
仍然参见图137,侧向定位的管状元件51080可相对于平移切割元件30052定位,使得切割元件30052能够切断管状元件51080。切割元件30052可在其中的穿孔处或附近切断管状元件51080。当管状元件51080被切为两半时,管状元件51080的被切断部分能够溶胀或膨胀,如图139所示。例如,管状元件51080可包含亲水性物质51099,该亲水性物质可在管状元件51080被切断时释放和/或暴露。此外,当亲水性物质51099接触组织T中的体液时,亲水性物质51099可以吸引所述流体,这可导致管状元件51080溶胀或膨胀。当管状元件51080膨胀时,围绕管状元件51080的补偿材料51024可以偏移或调整以适应溶胀的管状元件51080。例如,当补偿材料51024包含明胶时,所述明胶可以偏移以适应溶胀的管状元件51080。现在参见图140,管状元件51080的膨胀和补偿材料51024的偏移可导致组织厚度补偿件51020的对应膨胀。Still referring to FIG. 137 , the laterally positioned tubular element 51080 can be positioned relative to the translating cutting element 30052 such that the cutting element 30052 can sever the tubular element 51080 . Cutting element 30052 can sever tubular element 51080 at or near a perforation therein. When the tubular element 51080 is cut in half, the severed portion of the tubular element 51080 is capable of swelling or expanding, as shown in FIG. 139 . For example, the tubular element 51080 can contain a hydrophilic substance 51099 that can be released and/or exposed when the tubular element 51080 is severed. Additionally, when hydrophilic substance 51099 contacts bodily fluid in tissue T, hydrophilic substance 51099 can attract the fluid, which can cause tubular element 51080 to swell or expand. As the tubular element 51080 expands, the compensating material 51024 surrounding the tubular element 51080 can shift or adjust to accommodate the swollen tubular element 51080 . For example, when compensating material 51024 comprises gelatin, the gelatin may deflect to accommodate swollen tubular member 51080 . Referring now to FIG. 140 , expansion of the tubular element 51080 and deflection of the compensating material 51024 can result in a corresponding expansion of the tissue thickness compensator 51020 .
类似于本公开通篇所讨论的其他组织厚度补偿件,组织厚度补偿件51020可通过所施加的力变形或压缩。此外,组织厚度补偿件51020可为充分有弹性的,使得其在通过所施加的力变形时产生回弹力,并且可随后在移除所施加的力时回弹或部分地回弹。任选地,当组织厚度补偿件51020在钉截留区域30039中被捕获时,钉30030可使组织厚度补偿件51020变形。例如,钉30030可使在击发钉30030内捕获的组织厚度补偿件51020的管状元件51080和/或补偿材料51024变形。任选地,组织厚度补偿件51020的未捕获部分也可因钉截留区域30039中的变形而变形。在变形时,组织厚度补偿件51020可试图从变形构型中回弹。任选地,此类回弹可发生在管状元件51080的亲水性膨胀之前、管状元件51080的亲水性膨胀的同时,和/或管状元件51080的亲水性膨胀之后。当组织厚度补偿件51020试图回弹时,其可在也被捕获于钉截留区域30039中的组织上施加恢复力,如本文更详细地描述。Similar to the other tissue thickness compensators discussed throughout this disclosure, the tissue thickness compensator 51020 can be deformed or compressed by an applied force. Additionally, the tissue thickness compensator 51020 can be sufficiently elastic such that it develops a resilient force when deformed by an applied force, and can subsequently spring back or partially spring back when the applied force is removed. Optionally, the staples 30030 can deform the tissue thickness compensator 51020 when the tissue thickness compensator 51020 is captured in the staple entrapment region 30039 . For example, the staples 30030 can deform the tubular element 51080 and/or compensating material 51024 of the tissue thickness compensator 51020 captured within the fired staples 30030 . Optionally, non-captured portions of tissue thickness compensator 51020 may also be deformed by deformation in staple entrapment region 30039. When deformed, the tissue thickness compensator 51020 can attempt to spring back from the deformed configuration. Optionally, such rebound can occur prior to the hydrophilic expansion of the tubular element 51080 , concurrently with the hydrophilic expansion of the tubular element 51080 , and/or after the hydrophilic expansion of the tubular element 51080 . When the tissue thickness compensator 51020 attempts to spring back, it can exert a restoring force on tissue that is also captured in the staple entrapment region 30039, as described in greater detail herein.
任选地,组织厚度补偿件51020中管状元件51080和/或补偿材料51024中的至少一者可包含治疗剂51098。当包含治疗剂51098的管状元件51080被切断时,包含在管状元件51080内的治疗剂51098可被释放。此外,当补偿材料51024包含治疗剂51098时,治疗剂51098可在可生物吸收的补偿材料51024被吸收时释放。组织厚度补偿件51020可提供治疗剂51098的快速初始释放,之后是治疗剂51098的受控释放。例如,当包含治疗剂51098的管状元件51080被切断时,组织厚度补偿件51020可沿切割线提供从管状元件51080到组织T的治疗剂51098的快速初始释放。此外,当包含治疗剂51098的可生物吸收的补偿材料51024被吸收时,组织厚度补偿件51020可提供治疗剂51098的延长的受控释放。在治疗剂51098流入补偿材料51024之前,治疗剂51098中的至少一些可在管状元件51080中保持较短的一段时间。作为另外一种选择,治疗剂51098中的至少一些可保持在管状元件51080中直到管状元件51080被吸收。从管状元件51080中释放的治疗剂51098和补偿材料51024可以是相同的。作为另外一种选择,例如管状元件51080和补偿材料51024可包含不同的治疗剂或不同的治疗剂组合。Optionally, at least one of the tubular element 51080 and/or the compensating material 51024 in the tissue thickness compensator 51020 can comprise a therapeutic agent 51098. When the tubular member 51080 containing the therapeutic agent 51098 is severed, the therapeutic agent 51098 contained within the tubular member 51080 can be released. Additionally, when the compensation material 51024 includes a therapeutic agent 51098, the therapeutic agent 51098 can be released when the bioabsorbable compensation material 51024 is absorbed. The tissue thickness compensator 51020 can provide a quick initial release of the therapeutic agent 51098 followed by a controlled release of the therapeutic agent 51098. For example, when the tubular element 51080 containing the therapeutic agent 51098 is severed, the tissue thickness compensator 51020 can provide a rapid initial release of the therapeutic agent 51098 from the tubular element 51080 to the tissue T along the cut line. In addition, the tissue thickness compensator 51020 can provide extended controlled release of the therapeutic agent 51098 as the bioabsorbable compensating material 51024 comprising the therapeutic agent 51098 is absorbed. At least some of the therapeutic agent 51098 can remain in the tubular element 51080 for a short period of time before the therapeutic agent 51098 flows into the compensating material 51024 . Alternatively, at least some of the therapeutic agent 51098 can remain in the tubular element 51080 until the tubular element 51080 is absorbed. The therapeutic agent 51098 and compensating material 51024 released from the tubular element 51080 can be the same. Alternatively, for example, tubular element 51080 and compensating material 51024 may comprise different therapeutic agents or different combinations of therapeutic agents.
仍然参见图140,端部执行器12可几乎同时或快速相继地切割组织T和击发钉30030进入切断的组织T中。在这种情况下,钉30030可在切割元件30052已切断邻近组织T的管状元件51080之后立即被部署在组织T中。换句话讲,钉30030可在管状元件51080的溶胀以及组织厚度补偿件51020的膨胀之后立即接合组织厚度补偿件51020,或与其同时进行。在钉30030已被击发进入组织T中之后,组织厚度补偿件51020可继续增大或膨胀。在部署钉30030时,钉30030能够刺穿管状元件51080。在这种情况下,仍保持在被切断的管状元件51080中的治疗剂51098可从管状元件51080中释放,并且在一些情况下可覆盖击发钉30030的腿30031。Still referring to FIG. 140 , the end effector 12 can cut the tissue T and fire the staples 30030 into the severed tissue T substantially simultaneously or in rapid succession. In such instances, the staples 30030 can be deployed in the tissue T immediately after the cutting elements 30052 have severed the tubular element 51080 adjacent the tissue T. In other words, staples 30030 can engage tissue thickness compensator 51020 immediately after swelling of tubular element 51080 and expansion of tissue thickness compensator 51020, or concurrently therewith. After the staples 30030 have been fired into the tissue T, the tissue thickness compensator 51020 can continue to grow or expand. Upon deployment of the staples 30030, the staples 30030 are capable of piercing the tubular element 51080. In such a case, the therapeutic agent 51098 still retained in the severed tubular member 51080 can be released from the tubular member 51080 and, in some cases, can cover the legs 30031 of the firing pins 30030.
参见图141,组织厚度补偿件51020可例如通过模塑技术制造。根据本发明,框架或模具51120可包括第一纵向侧51122和第二纵向侧51124。每个纵向侧51124可包括一个或多个凹口51130,所述一个或多个凹口可各自能够接收管状元件51080的第一末端50183或第二末端50185。管状元件51080的第一末端50183可被定位在第一纵向侧51122上的第一凹口51130a中,并且管状元件51080的第二末端50183可被定位在第二纵向侧51124上的第二凹口51130b中,使得管状元件51080侧向地横贯框架51120。凹口51180可包括半圆形沟槽,该半圆形沟槽可以牢固地贴合其中管状元件51080的第一末端50183或第二末端50185。第一凹口51130a可被定位成直接在第二凹口51130b的对面,并且管状元件51080可被定位成垂直于或至少基本上垂直于框架51120的纵向轴线。作为另外一种选择,第一凹口51130a可从第二凹口51130b偏移,使得管状元件51080相对于框架51120的纵向轴线成角度定位。作为另外的另选形式,至少一个管状元件51080可被纵向定位在框架51120内,使得管状元件在框架51120的横向侧51126、51128之间延伸。此外,例如,至少一个管状元件可成角度地定位在框架的横向侧51126、51128上的两个凹口之间,和/或横向侧51126上的凹口与纵向侧51124上的凹口之间的框架内。框架51120可包括支撑凸缘51136,该支撑凸缘可支撑定位在框架51120内的管状元件51080。Referring to Fig. 141, the tissue thickness compensator 51020 can be manufactured, for example, by molding techniques. According to the present invention, the frame or mold 51120 may include a first longitudinal side 51122 and a second longitudinal side 51124 . Each longitudinal side 51124 can include one or more notches 51130 that can each be configured to receive either the first end 50183 or the second end 50185 of the tubular element 51080 . The first end 50183 of the tubular element 51080 can be positioned in the first notch 51130a on the first longitudinal side 51122 and the second end 50183 of the tubular element 51080 can be positioned in the second notch on the second longitudinal side 51124 51130b, such that the tubular member 51080 traverses the frame 51120 laterally. The notch 51180 can include a semicircular groove that can securely fit either the first end 50183 or the second end 50185 of the tubular member 51080 therein. The first notch 51130a can be positioned directly across from the second notch 51130b, and the tubular member 51080 can be positioned perpendicular, or at least substantially perpendicular, to the longitudinal axis of the frame 51120. Alternatively, the first notch 51130a may be offset from the second notch 51130b such that the tubular member 51080 is positioned at an angle relative to the longitudinal axis of the frame 51120 . As a further alternative, at least one tubular element 51080 may be positioned longitudinally within frame 51120 such that the tubular element extends between lateral sides 51126 , 51128 of frame 51120 . Also, for example, at least one tubular element may be positioned angularly between two notches on the lateral sides 51126, 51128 of the frame, and/or between a notch on the lateral side 51126 and a notch on the longitudinal side 51124 within the framework. The frame 51120 can include a support flange 51136 that can support the tubular element 51080 positioned within the frame 51120 .
例如,框架51120可包括凹口51130以容纳十二个管状元件51080。框架凹口51130可被管状元件51080填充,而作为另外一种选择,并非所有凹口51130均可被填充。任选地,至少一个管状元件51080可定位在框架51120内。至少一半凹口51130可以接收管状元件51080。一旦管状元件51080被定位在框架51120内,补偿材料51024即可被添加到框架51120。在被添加到框架51120时,补偿材料51024可为流体的。例如,补偿材料51024可被倾注到框架51120内并且可围绕定位于其中的管状元件51080流动。参见图142,流动的补偿材料51024可围绕由框架51120中的凹口51130支撑的管状元件51080流动。在补偿材料51024固化,或至少充分地固化后,现在参见图143,可将包含补偿材料51024和管状元件51080的组织厚度补偿件51020从框架51120中移除。可对组织厚度补偿件51020进行修剪。例如,可将多余的补偿材料51024从组织厚度补偿件51020中移除,使得补偿材料的纵向侧为基本上平坦的。此外,参见图144,管状元件51080的第一末端50183和第二末端50185可被压在一起,或使其闭合以密封管状元件51080。可在将管状元件51080放置在框架51120中之前使所述端部闭合。作为另外一种选择,修剪过程可横切端部51083、51085并且热堆积过程可用于密封和/或闭合管状元件51080的端部51083、51085。For example, frame 51120 may include recesses 51130 to accommodate twelve tubular elements 51080 . Frame notches 51130 may be filled by tubular elements 51080, while alternatively not all notches 51130 may be filled. Optionally, at least one tubular element 51080 can be positioned within frame 51120 . At least half of the notch 51130 can receive the tubular element 51080 . Once the tubular element 51080 is positioned within the frame 51120, compensating material 51024 can be added to the frame 51120. When added to frame 51120, compensation material 51024 may be fluid. For example, compensating material 51024 can be poured into frame 51120 and can flow around tubular element 51080 positioned therein. Referring to FIG. 142 , the flowing compensating material 51024 can flow around the tubular element 51080 supported by the notch 51130 in the frame 51120 . After the compensating material 51024 is cured, or at least sufficiently cured, referring now to FIG. 143 , the tissue thickness compensator 51020 comprising the compensating material 51024 and the tubular elements 51080 can be removed from the frame 51120 . The tissue thickness compensator 51020 can be trimmed. For example, excess compensating material 51024 can be removed from tissue thickness compensator 51020 such that the longitudinal sides of the compensating material are substantially flat. Additionally, referring to FIG. 144 , the first end 50183 and the second end 50185 of the tubular member 51080 can be pressed together, or otherwise closed, to seal the tubular member 51080 . The ends may be closed prior to placing the tubular element 51080 in the frame 51120 . Alternatively, a trimming process may transect the ends 51083 , 51085 and a heat deposition process may be used to seal and/or close the ends 51083 , 51085 of the tubular element 51080 .
再次参见图141,刚性销51127可被定位在每个管状元件51080内。例如,刚性销51127可延伸穿过管状元件51080的纵向管腔。刚性销51127可延伸超过每个管状元件51080,使得刚性销51127可被定位在框架51120中的凹口51130内。例如,在具有刚性销51127的实施例中,当补偿材料51204被倾注到框架51120内并且当流动的补偿材料51024围绕管状元件51080流动时,刚性销51127可支撑管状元件51080。一旦补偿材料51024固化、硬化和/或冻干,或充分地固化、硬化和/或冻干,即可将组织厚度补偿件51020从框架51120中移除,并且可将刚性销51127从管状元件51080的纵向管腔中移除。然后可使用例如药物填充管状元件51080。在用药物填充管状元件51080之后,可对例如包括管状元件51080的端部51083、51085的组织厚度补偿件51020进行修剪。组织厚度补偿件51020可例如被冲切,和/或例如通过热和/或压力密封。Referring again to FIG. 141 , a rigid pin 51127 can be positioned within each tubular element 51080 . For example, rigid pin 51127 can extend through the longitudinal lumen of tubular element 51080. Rigid pin 51127 can extend beyond each tubular element 51080 such that rigid pin 51127 can be positioned within notch 51130 in frame 51120 . For example, in embodiments having rigid pins 51127, rigid pins 51127 may support tubular element 51080 as compensating material 51204 is poured into frame 51120 and as flowing compensating material 51024 flows around tubular element 51080. Once the compensating material 51024 is cured, hardened and/or lyophilized, or sufficiently cured, hardened and/or lyophilized, the tissue thickness compensator 51020 can be removed from the frame 51120 and the rigid pin 51127 can be removed from the tubular element 51080 removed from the longitudinal lumen. Tubular element 51080 may then be filled with, for example, a drug. After filling the tubular element 51080 with drug, the tissue thickness compensator 51020 , for example including the ends 51083 , 51085 of the tubular element 51080 , can be trimmed. The tissue thickness compensator 51020 can be die cut, for example, and/or sealed, for example, by heat and/or pressure.
如本文所述,组织厚度补偿件52020可包括多个管状元件51080。现在参见图145,管状元件51080可包括不同的材料特性、尺寸和几何形状。例如,第一管状元件51080a可包含第一厚度和第一材料,并且第二管状元件51080b可包含第二厚度和第二材料。任选地,组织厚度补偿件52020中的至少两个管状元件51080可包含相同的材料。作为另外一种选择,组织厚度补偿件5202中的每个管状元件51080可包含不同的材料。相似地,组织厚度补偿件52020中的至少两个管状元件51080可包括相同的几何形状。作为另外一种选择,组织厚度补偿件52020中的每个管状元件51080可包括不同的几何形状。Tissue thickness compensator 52020 can include a plurality of tubular elements 51080, as described herein. Referring now to FIG. 145, the tubular member 51080 can comprise different material properties, sizes and geometries. For example, a first tubular element 51080a can comprise a first thickness and a first material, and a second tubular element 51080b can comprise a second thickness and a second material. Optionally, at least two tubular elements 51080 in tissue thickness compensator 52020 can comprise the same material. Alternatively, each tubular element 51080 in tissue thickness compensator 5202 may comprise a different material. Similarly, at least two tubular elements 51080 in tissue thickness compensator 52020 can comprise the same geometry. Alternatively, each tubular element 51080 in the tissue thickness compensator 52020 can comprise a different geometry.
现在参见图208-图211,组织厚度补偿件51220可包括侧向地横贯组织厚度补偿件51220的至少一个管状元件51280。参见图208,组织厚度补偿件51220可相对于端部执行器12的砧座30060定位。例如,组织厚度补偿件51220可被固定到端部执行器12的砧座30060的固定表面30061。主要参见图209,例如,管状元件51280可包括胶囊状形状。例如,管状元件51280可包含聚合物组合物,诸如可生物吸收的生物相容性弹性体聚合物。Referring now to FIGS. 208-211 , the tissue thickness compensator 51220 can include at least one tubular element 51280 laterally traversing the tissue thickness compensator 51220 . Referring to FIG. 208 , the tissue thickness compensator 51220 can be positioned relative to the anvil 30060 of the end effector 12 . For example, tissue thickness compensator 51220 may be secured to fixation surface 30061 of anvil 30060 of end effector 12 . Referring primarily to FIG. 209, for example, tubular element 51280 can comprise a capsule-like shape. For example, tubular element 51280 can comprise a polymer composition, such as a bioabsorbable biocompatible elastomeric polymer.
再次参见图208,组织厚度补偿件51220还可包含至少部分地围绕管状元件51280的补偿材料51224。例如,补偿材料51224可包含可生物吸收的聚合物,诸如冻干多糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和/或氧化再生纤维素(ORC)。与上文类似,补偿材料51024可使管状元件51280在组织厚度补偿件51220中保持就位。此外,补偿材料51224可被固定到砧座30060的固定表面30061,使得补偿材料51220牢固地定位在端部执行器12中。补偿材料51224可包含至少一种药物。Referring again to FIG. 208 , the tissue thickness compensator 51220 can further comprise a compensating material 51224 at least partially surrounding the tubular element 51280 . For example, the compensation material 51224 may comprise bioabsorbable polymers such as lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and/or oxidized regenerated cellulose (ORC). Similar to the above, the compensating material 51024 can hold the tubular element 51280 in place within the tissue thickness compensator 51220 . Additionally, the compensating material 51224 can be secured to the securing surface 30061 of the anvil 30060 such that the compensating material 51220 is securely positioned within the end effector 12 . The compensation material 51224 can comprise at least one drug.
仍然参见图208,侧向定位的管状元件51280可相对于平移滑动件30250上的切割元件30252定位,使得可平移的切割元件30252能够切断管状元件51280。例如,切割元件30252可在每个管状元件51280中心处或附近切断管状元件51280。当管状元件51280被切为两半时,管状元件51280的被切断部分能够溶胀或膨胀,如图208所示。主要参见图210,管状元件51280可包含亲水性物质51099,该亲水性物质可在管状元件51280被切断时释放和/或暴露。此外,现在参见图211,当亲水性物质51099接触组织T中的体液时,亲水性物质51099可以吸引所述流体,这可导致管状元件51280溶胀或膨胀。当管状元件51280膨胀时,围绕管状元件51280的补偿材料51224可以偏移或调整以适应溶胀的管状元件51280。例如,当补偿材料51224包含明胶时,所述明胶可以偏移以适应溶胀的管状元件51280。再次参见图208,管状元件51280的膨胀和补偿材料51224的偏移可导致组织厚度补偿件51220的对应膨胀。Still referring to FIG. 208 , the laterally positioned tubular element 51280 can be positioned relative to the cutting element 30252 on the translating slide 30250 such that the translatable cutting element 30252 can sever the tubular element 51280 . For example, cutting element 30252 can sever tubular elements 51280 at or near the center of each tubular element 51280 . When the tubular element 51280 is cut in half, the severed portion of the tubular element 51280 is capable of swelling or expanding, as shown in FIG. 208 . Referring primarily to FIG. 210, the tubular member 51280 can contain a hydrophilic substance 51099 that can be released and/or exposed when the tubular member 51280 is severed. In addition, referring now to FIG. 211 , when hydrophilic substance 51099 contacts bodily fluid in tissue T, hydrophilic substance 51099 can attract the fluid, which can cause tubular element 51280 to swell or expand. As the tubular element 51280 expands, the compensating material 51224 surrounding the tubular element 51280 can shift or adjust to accommodate the swollen tubular element 51280 . For example, when compensating material 51224 comprises gelatin, the gelatin may deflect to accommodate swollen tubular member 51280 . Referring again to FIG. 208 , expansion of the tubular element 51280 and deflection of the compensating material 51224 can result in a corresponding expansion of the tissue thickness compensator 51220 .
类似于本公开通篇所讨论的其他组织厚度补偿件,组织厚度补偿件51220可通过所施加的力变形或压缩。此外,组织厚度补偿件51220可为充分有弹性的,使得其在通过所施加的力变形时产生回弹力,并且可随后在移除所施加的力时回弹或部分地回弹。任选地,当组织厚度补偿件51220被捕获在钉截留区域30039(图88)中时,钉30030可使组织厚度补偿件51220变形。例如,钉30030可使在击发钉30030内捕获的组织厚度补偿件51220的管状元件51280和/或补偿材料51224变形。任选地,组织厚度补偿件51220的未捕获部分也可因钉截留区域30039中的变形而变形。在变形时,组织厚度补偿件51220可试图从变形构型中回弹。任选地,此类回弹可发生在管状元件51280的亲水性膨胀之前、管状元件51280的亲水性膨胀的同时,和/或管状元件51280的亲水性膨胀之后。当组织厚度补偿件51220试图回弹时,其可在也被捕获于钉截留区域30039中的组织上施加恢复力,如本文更详细地描述。Similar to other tissue thickness compensators discussed throughout this disclosure, tissue thickness compensator 51220 can be deformed or compressed by applied force. Additionally, the tissue thickness compensator 51220 can be sufficiently elastic such that it develops a resilient force when deformed by an applied force, and can subsequently rebound or partially rebound when the applied force is removed. Optionally, the staples 30030 can deform the tissue thickness compensator 51220 when the tissue thickness compensator 51220 is captured in the staple entrapment region 30039 (FIG. 88). For example, the staples 30030 can deform the tubular element 51280 and/or compensating material 51224 of the tissue thickness compensator 51220 captured within the fired staples 30030 . Optionally, non-captured portions of tissue thickness compensator 51220 may also be deformed by deformation in staple entrapment region 30039. When deformed, the tissue thickness compensator 51220 can attempt to spring back from the deformed configuration. Optionally, such rebound can occur prior to the hydrophilic expansion of the tubular element 51280 , concurrently with the hydrophilic expansion of the tubular element 51280 , and/or after the hydrophilic expansion of the tubular element 51280 . When the tissue thickness compensator 51220 attempts to spring back, it can exert a restorative force on tissue that is also captured in the staple entrapment region 30039, as described in greater detail herein.
参见图146-图149,组织厚度补偿件52020可包括侧向地横贯组织厚度补偿件52020(类似于本文所述的至少一个组织厚度补偿件)的一个或多个管状元件52080。组织厚度补偿件52020可包括多个侧向地横贯的管状元件52080。组织厚度补偿件52020还可包括一个或多个材料片52024,该材料片保持或保留组织厚度补偿件52020中的至少一个管状元件52080。一个或多个材料片52024可被定位在管状元件52080的上方和/或下方,并且可牢固地保持组织厚度补偿件52020中的每个管状元件52080。主要参见图146,组织厚度补偿件可包括第一材料片52024a和第二材料片52024b。管状元件52080可被定位在第一材料片52024a和第二材料片52024b之间。此外,仍然参见图146,材料片52024b可被固定到钉仓30000的刚性支撑部分的顶部平台表面30011,使得组织厚度补偿件52020牢固地定位在端部执行器12中。作为另外一种选择,一个或多个材料片52024可被固定到砧座30060或以其他的方式保持在端部执行器12中。146-149, the tissue thickness compensator 52020 can comprise one or more tubular elements 52080 laterally traversing the tissue thickness compensator 52020 (similar to at least one tissue thickness compensator described herein). The tissue thickness compensator 52020 can include a plurality of laterally traversing tubular elements 52080 . The tissue thickness compensator 52020 can also include one or more sheets of material 52024 that hold or retain at least one tubular element 52080 of the tissue thickness compensator 52020 . One or more sheets of material 52024 can be positioned above and/or below the tubular elements 52080 and can securely hold each tubular element 52080 in the tissue thickness compensator 52020 . Referring primarily to FIG. 146, the tissue thickness compensator can include a first sheet of material 52024a and a second sheet of material 52024b. The tubular element 52080 can be positioned between the first piece of material 52024a and the second piece of material 52024b. In addition, still referring to FIG. 146 , a sheet of material 52024b can be secured to the top deck surface 30011 of the rigid support portion of the staple cartridge 30000 such that the tissue thickness compensator 52020 is securely positioned within the end effector 12 . Alternatively, one or more pieces of material 52024 may be secured to anvil 30060 or otherwise retained in end effector 12 .
主要参见图147,组织厚度补偿件52020可为多孔的和/或可渗透的。例如,材料片52024可包括多个孔52026。孔52026可为基本上圆形的。孔52036在材料片52024中可为可见的。作为另外一种选择,孔52036可为微观的。仍然参见图147,管状元件52080也可包括多个孔52026。参见图148,组织厚度补偿件52120可包括材料片52124,该材料片包括多个非圆形的孔52126。例如,孔52126可包括菱形和/或开槽形状。作为另外一种选择,参见图149,组织厚度补偿件52220可包括管状元件52280,该管状元件包括可渗透的管状晶格52292。例如,材料片52224可包含可生物吸收的生物相容性弹性体聚合物并且可包含药物。Referring primarily to FIG. 147, the tissue thickness compensator 52020 can be porous and/or permeable. For example, sheet of material 52024 may include a plurality of apertures 52026 . Aperture 52026 may be substantially circular. Holes 52036 may be visible in sheet of material 52024 . Alternatively, the pores 52036 may be microscopic. Still referring to FIG. 147 , the tubular element 52080 can also include a plurality of apertures 52026 . Referring to FIG. 148 , a tissue thickness compensator 52120 can include a sheet of material 52124 including a plurality of non-circular apertures 52126 . For example, apertures 52126 may comprise diamond and/or slotted shapes. Alternatively, referring to FIG. 149 , the tissue thickness compensator 52220 can comprise a tubular element 52280 comprising a permeable tubular lattice 52292 . For example, the sheet of material 52224 may comprise a bioabsorbable biocompatible elastomeric polymer and may comprise a drug.
至少一个管状元件52080能够溶胀或膨胀,如图150A-图150D所示。例如,参见图150A,管状元件52080可被定位在组织厚度补偿件52020中的第一材料片52024a和第二材料片52024b中间。当组织厚度补偿件52020接触组织T时,如图150B所示,组织厚度补偿件52020可以膨胀。例如,管状元件52080可包含在暴露于组织T之内和/或之上的流体时膨胀的亲水性物质52099。此外,材料片52024和管状元件52080可为可渗透的,如本文所述,使得来自组织T的流体可渗透组织厚度补偿件52020从而允许流体接触管状元件52080内的亲水性物质52099。当管状元件52080膨胀时,围绕管状元件52080的材料片52024可以偏移或调整以适应溶胀的管状元件52080。类似于本公开通篇所讨论的各种组织厚度补偿件,膨胀的组织厚度补偿件52020可通过所施加的力(诸如通过击发钉施加的压缩力)变形或压缩,如图150C所示。此外,组织厚度补偿件52020可为充分有弹性的,使得其在通过所施加的力变形时产生回弹力,并且可随后在移除所施加的力时回弹。现在参见图150D和图150E,组织厚度补偿件52020可在不同钉截留区域30039中回弹至不同的构型,以合适地适应被捕获的组织T。At least one tubular element 52080 is capable of swelling or expanding, as shown in FIGS. 150A-150D . For example, referring to FIG. 150A , a tubular element 52080 can be positioned in a tissue thickness compensator 52020 intermediate a first sheet of material 52024a and a second sheet of material 52024b. When the tissue thickness compensator 52020 contacts the tissue T, as shown in Figure 150B, the tissue thickness compensator 52020 can expand. For example, tubular element 52080 may comprise a hydrophilic substance 52099 that swells upon exposure to fluid in and/or on tissue T. Additionally, the sheet of material 52024 and tubular element 52080 may be permeable, as described herein, such that fluid from the tissue T is permeable to the tissue thickness compensator 52020 thereby allowing fluid to contact the hydrophilic substance 52099 within the tubular element 52080 . As the tubular element 52080 expands, the sheet of material 52024 surrounding the tubular element 52080 can shift or adjust to accommodate the swollen tubular element 52080 . Similar to the various tissue thickness compensators discussed throughout this disclosure, the expanded tissue thickness compensator 52020 can be deformed or compressed by an applied force, such as a compressive force applied by firing staples, as shown in Figure 150C. Additionally, the tissue thickness compensator 52020 can be sufficiently elastic such that it develops a resilient force when deformed by an applied force, and can subsequently spring back when the applied force is removed. Referring now to FIGS. 150D and 150E , the tissue thickness compensator 52020 can spring back to different configurations in different staple entrapment regions 30039 to suitably accommodate the captured tissue T.
参见图151-图156,组织厚度补偿件53020可包括多个竖直定位的管状元件53080。任选地,每个管状元件53080可包括管状轴线,该管状轴线基本上垂直于钉仓30000的刚性支撑部分30010的顶部平台表面30011。此外,每个管状元件53080的第一末端可例如邻近顶部平台表面30011定位。管状元件53080可例如为可变形的并且可包含弹性体聚合物。任选地,如图152所示,管状元件53080可在被缝合的组织T捕获在钉截留区域30039中时被压缩。管状元件53080可包含弹性材料,使得当管状元件53080试图从变形构型回弹时,管状元件53080的变形产生恢复力。管状元件53080的变形可为至少部分弹性和至少部分塑性的。管状元件53080能够在所施加的力下充当弹簧,并且能够不扣紧。参见图153,管状元件53080可为基本上圆柱形。参见图154,管状元件53180可包括扣紧区域53112。当向管状元件53180施加压缩力时,其能够在扣紧区域53112处扣紧或变形。管状元件53180可以弹性地和/或塑性地变形,然后被设计为在预先选择的扣紧力下在扣紧区域53112处突然扣紧。Referring to FIGS. 151-156 , a tissue thickness compensator 53020 can comprise a plurality of vertically positioned tubular elements 53080 . Optionally, each tubular element 53080 can include a tubular axis that is substantially perpendicular to the top deck surface 30011 of the rigid support portion 30010 of the staple cartridge 30000. Additionally, the first end of each tubular element 53080 can be positioned adjacent to the top deck surface 30011, for example. The tubular element 53080 may, for example, be deformable and may comprise an elastomeric polymer. Optionally, as shown in FIG. 152 , the tubular element 53080 can be compressed when the stapled tissue T is captured in the staple entrapment region 30039 . The tubular element 53080 may comprise a resilient material such that deformation of the tubular element 53080 produces a restoring force when the tubular element 53080 attempts to rebound from the deformed configuration. The deformation of the tubular element 53080 can be at least partially elastic and at least partially plastic. The tubular element 53080 can act as a spring under applied force and can be unfastened. Referring to Fig. 153, the tubular member 53080 can be substantially cylindrical. Referring to FIG. 154 , the tubular element 53180 can include a fastening region 53112 . When a compressive force is applied to the tubular element 53180, it is capable of fastening or deforming at the fastening region 53112. The tubular element 53180 can be elastically and/or plastically deformed and then designed to snap fasten at a fastening region 53112 under a preselected fastening force.
主要参见图155,第一管状元件53080可被定位在钉腔30012的第一末端处,并且另一个管状元件53080可被定位在钉腔30012的第二末端处。如图153所示,管状元件53080可包括延伸穿过其中的管腔53084。再次参见图152,当钉30030从初始位置运动到击发位置时,每个钉腿30032能够穿过每个管状元件53080的管腔53084。作为另外一种选择,主要参见图156,竖直定位的管状元件54080可被布置在组织厚度补偿件54020中,使得管状元件54080彼此邻接或接触。换句话讲,管状元件54080可被群集或集中在一起。管状元件54080可系统地被布置在组织厚度补偿件54020中;然而,在其他情况下,管状元件54080可以被随机布置。Referring primarily to FIG. 155 , a first tubular element 53080 can be positioned at a first end of the staple cavity 30012 and another tubular element 53080 can be positioned at a second end of the staple cavity 30012 . As shown in FIG. 153, the tubular member 53080 can include a lumen 53084 extending therethrough. Referring again to FIG. 152, each staple leg 30032 can pass through the lumen 53084 of each tubular element 53080 as the staples 30030 are moved from the initial position to the fired position. Alternatively, referring primarily to FIG. 156, the vertically positioned tubular elements 54080 may be disposed within the tissue thickness compensator 54020 such that the tubular elements 54080 abut or contact each other. In other words, the tubular elements 54080 can be clustered or gathered together. The tubular elements 54080 can be systematically arranged in the tissue thickness compensator 54020; however, in other cases, the tubular elements 54080 can be randomly arranged.
再次参见图151、图155和图156,组织厚度补偿件53020也可包括材料片53024,该材料片使管状元件53080保持或保留在组织厚度补偿件53020中。材料片53024可被定位在管状元件53080的上方和/或下方,并且可牢固地保持组织厚度补偿件53020中的每个管状元件53080。组织厚度补偿件53020可包括第一和第二材料片53024。管状元件53080可被定位在第一和第二材料片53024之间。另外,材料片53024可被固定到钉仓30000的刚性支撑部分的顶部平台表面30011,使得组织厚度补偿件53020牢固地定位在端部执行器12中。作为另外一种选择,材料片53024可被固定到砧座30060或以其他的方式保持在端部执行器12中。材料片53024可为充分可变形的,使得材料片53024在组织厚度补偿件内的弹簧55080变形时变形。Referring again to FIGS. 151 , 155 and 156 , the tissue thickness compensator 53020 can also include a sheet of material 53024 that retains or retains the tubular element 53080 within the tissue thickness compensator 53020 . Sheets of material 53024 can be positioned above and/or below tubular elements 53080 and can securely hold each tubular element 53080 in tissue thickness compensator 53020 . Tissue thickness compensator 53020 can include first and second sheets 53024 of material. The tubular element 53080 can be positioned between the first and second sheets of material 53024 . Additionally, the sheet of material 53024 can be secured to the top deck surface 30011 of the rigid support portion of the staple cartridge 30000 such that the tissue thickness compensator 53020 is securely positioned within the end effector 12 . Alternatively, the piece of material 53024 may be secured to the anvil 30060 or otherwise retained in the end effector 12 . The sheet of material 53024 may be sufficiently deformable such that the sheet of material 53024 deforms when the spring 55080 within the tissue thickness compensator deforms.
参见图157和图158,组织厚度补偿件55020可包括至少一个弹簧55080,所述弹簧是充分有弹性的,使得其能够在变形时产生回弹力。主要参见图157,组织厚度补偿件55020可包括多个弹簧55080,诸如三行弹簧55080。弹簧55080可被系统地和/或无规地布置在组织厚度补偿件55020中。例如,弹簧55080可包含弹性体聚合物。弹簧55080的形状可允许其变形。弹簧55080可从初始构型变形至变形构型。例如,当组织厚度补偿件55020的一部分被捕获在钉截留区域30039中时,钉截留区域30039之内和/或周围的弹簧55080可以变形。例如,弹簧55080可在针对击发钉30030施加的压缩力下扣紧或塌缩,并且弹簧55080可产生恢复力,所述恢复力取决于变形弹簧55080的弹簧劲度系数和/或弹簧55080的变形量。弹簧55080可在由击发钉30030施加的压缩力下充当海绵。另外,弹簧55080可包含补偿材料,如本公开通篇更详细地描述。Referring to Figures 157 and 158, the tissue thickness compensator 55020 can include at least one spring 55080 that is sufficiently resilient such that it can generate a resilient force when deformed. Referring primarily to FIG. 157 , the tissue thickness compensator 55020 can include a plurality of springs 55080 , such as three rows of springs 55080 . Springs 55080 can be systematically and/or randomly arranged within tissue thickness compensator 55020. For example, spring 55080 may comprise an elastomeric polymer. The shape of the spring 55080 allows it to deform. The spring 55080 is deformable from an initial configuration to a deformed configuration. For example, when a portion of the tissue thickness compensator 55020 is captured in the staple entrapment region 30039, the spring 55080 in and/or around the staple entrapment region 30039 can deform. For example, the spring 55080 can buckle or collapse under a compressive force applied against the firing pin 30030, and the spring 55080 can generate a restoring force that depends on the spring rate of the deforming spring 55080 and/or the deformation of the spring 55080 quantity. The spring 55080 can act as a sponge under the compressive force applied by the firing spike 30030. Additionally, the spring 55080 may comprise compensating material, as described in more detail throughout this disclosure.
组织厚度补偿件55020还可包含一个或多个材料片55024,该材料片保持或保留组织厚度补偿件55020中的至少一个弹簧55080。材料片55024可被定位在弹簧55080的上方和/或下方,并且可牢固地保持组织厚度补偿件55020中的弹簧55080。组织厚度补偿件55020可包括第一材料片55024a和第二材料片55024b。管状元件52080可被定位在第一材料片55024a和第二材料片55024b之间。主要参见图158,组织厚度补偿件55020还可包括第三材料片55024c,该第三材料片邻近第一材料片55024a或第二材料片55024b定位。任选地,至少一个材料片55024可被固定到钉仓30000的刚性支撑部分的顶部平台表面30011,使得组织厚度补偿件55020牢固地定位在端部执行器12中。作为另外一种选择,至少一个材料片55024可被固定到砧座30060或以其他的方式保持在端部执行器12中。The tissue thickness compensator 55020 can also include one or more sheets of material 55024 that hold or retain at least one spring 55080 in the tissue thickness compensator 55020 . The sheet of material 55024 can be positioned above and/or below the spring 55080 and can securely retain the spring 55080 in the tissue thickness compensator 55020 . The tissue thickness compensator 55020 can include a first sheet of material 55024a and a second sheet of material 55024b. The tubular element 52080 can be positioned between the first piece of material 55024a and the second piece of material 55024b. Referring primarily to FIG. 158, the tissue thickness compensator 55020 can also include a third piece of material 55024c positioned adjacent to either the first piece of material 55024a or the second piece of material 55024b. Optionally, at least one sheet of material 55024 can be secured to the top deck surface 30011 of the rigid support portion of the staple cartridge 30000 such that the tissue thickness compensator 55020 is securely positioned within the end effector 12 . Alternatively, at least one piece of material 55024 may be secured to anvil 30060 or otherwise retained in end effector 12 .
现在参见图158,当钉30030从钉仓30000中被击发时(图156),钉30030可以接合组织厚度补偿件55020。击发钉30030可以将组织T和组织厚度补偿件55020的一部分捕获在钉截留区域30039中。弹簧55080可为可变形的,使得组织厚度补偿件55020在被击发钉30030捕获时压缩。弹簧55080可被定位在组织厚度补偿件55020中的击发钉30030之间。作为另外一种选择,可在钉截留区域30039内捕获至少一个弹簧55080。Referring now to FIG. 158 , the staples 30030 can engage the tissue thickness compensator 55020 when the staples 30030 are fired from the staple cartridge 30000 ( FIG. 156 ). Firing the staples 30030 can capture the tissue T and a portion of the tissue thickness compensator 55020 in the staple entrapment region 30039. Spring 55080 may be deformable such that tissue thickness compensator 55020 compresses when captured by fired staples 30030 . The spring 55080 can be positioned between the fired staples 30030 in the tissue thickness compensator 55020 . Alternatively, at least one spring 55080 may be captured within the staple entrapment region 30039.
参见图159,组织厚度补偿件60020可包括至少两个补偿层60022。组织厚度补偿件60020可包括多个补偿层60022,该多个补偿层可在彼此的顶部叠堆、并排定位,或它们的组合。如本文更详细地描述,组织厚度补偿件60020的补偿层60022可包括例如不同的几何形状和/或材料特性。此外,如本文更详细地描述,凹坑和/或通道可存在于相邻叠堆的补偿层60022之间。例如,组织厚度补偿件62020可包括六个补偿层62022a、62022b、62022c、62022d、62022e、62022f,所述六个补偿层可在彼此的顶部相邻叠堆(图174)。Referring to FIG. 159 , a tissue thickness compensator 60020 can include at least two compensation layers 60022 . The tissue thickness compensator 60020 can include a plurality of compensation layers 60022 that can be stacked on top of each other, positioned side by side, or a combination thereof. As described in greater detail herein, the compensation layers 60022 of the tissue thickness compensator 60020 can include, for example, different geometries and/or material properties. Additionally, as described in greater detail herein, pits and/or channels may exist between adjacent stacks of compensation layers 60022 . For example, a tissue thickness compensator 62020 can include six compensation layers 62022a, 62022b, 62022c, 62022d, 62022e, 62022f that can be stacked adjacently on top of each other (FIG. 174).
参见图160、图161和图163-图168,组织厚度补偿件可包括第一补偿层60122a和第二补偿层60122b。第一补偿层60122a可在第二补偿层60122b的顶部相邻叠堆。相邻叠堆的补偿层60122可由分离间隙或凹坑60132隔开。主要参见图160,组织厚度补偿件60120也可包括定位在第一补偿层60122a和第二补偿层60122b之间的至少一个悬臂梁或支撑件60124。支撑件60124能够相对于第二补偿层60122b来定位第一补偿层60122a,使得补偿层60122由分离间隙60132隔开。如本文更详细地描述,支撑件60124和/或补偿层60122a、60122b的变形例如可减小分离间隙60132。160, 161, and 163-168, the tissue thickness compensator can include a first compensation layer 60122a and a second compensation layer 60122b. The first compensation layer 60122a may be adjacently stacked on top of the second compensation layer 60122b. Adjacent stacks of compensation layers 60122 may be separated by separation gaps or pits 60132 . Referring primarily to FIG. 160, the tissue thickness compensator 60120 can also include at least one cantilever beam or support 60124 positioned between the first compensation layer 60122a and the second compensation layer 60122b. The support 60124 is capable of positioning the first compensation layer 60122a relative to the second compensation layer 60122b such that the compensation layers 60122 are separated by a separation gap 60132 . As described in greater detail herein, deformation of the support 60124 and/or compensating layers 60122a, 60122b, for example, can reduce the separation gap 60132.
组织厚度补偿件的支撑梁可包括多个几何形状和尺寸。例如,支撑梁可为简单的I形梁、居中的单弯支撑梁60124(图160)、偏心的单弯支撑梁60224(图161)、椭圆支撑梁60324(图163)、多弯支撑梁60424(图164),和/或对称的双悬臂支撑梁60524(图165)。此外,现在参见图160、图166和图167,例如,支撑梁60624可薄于至少一个补偿层60122(图166),支撑梁60724可厚于至少一个补偿层60122(图167),和/或支撑梁60124可为与至少一个补偿层60122(图160)基本上相同的厚度。支撑梁60124的材料、几何形状和/或尺寸例如可影响组织厚度补偿件60120的可变形性和回弹力弹性。The support beams of the tissue thickness compensator can include a variety of geometries and sizes. For example, the support beam can be a simple I-shaped beam, a centered single-bend support beam 60124 (FIG. 160), an eccentric single-bend support beam 60224 (FIG. 161), an elliptical support beam 60324 (FIG. 163), a multi-bend support beam 60424 (FIG. 164), and/or symmetrical double cantilever support beams 60524 (FIG. 165). In addition, referring now to FIGS. 160, 166, and 167, for example, the support beams 60624 can be thinner than the at least one compensation layer 60122 (FIG. 166), the support beams 60724 can be thicker than the at least one compensation layer 60122 (FIG. 167), and/or The support beams 60124 can be substantially the same thickness as the at least one compensation layer 60122 (FIG. 160). The material, geometry, and/or dimensions of the support beams 60124 can affect the deformability and resiliency of the tissue thickness compensator 60120, for example.
仍然参见图160,例如,组织厚度补偿件60120的补偿层60122和支撑梁60124可包含不同的材料,诸如结构化材料、生物材料和/或电气材料。例如,至少一个补偿层60122可包含聚合物组合物。聚合物组合物可包含至少部分弹性的材料,使得补偿层60122和/或支撑梁60124的变形可产生回弹力。补偿层60122的聚合物组合物可包含不可吸收的聚合物、可吸收的聚合物或它们的组合。例如,可吸收的聚合物可包括可生物吸收的生物相容性弹性体聚合物。此外,补偿层60122的聚合物组合物可包括合成聚合物、非合成聚合物或它们的组合。合成聚合物的示例包括但不限于聚乙醇酸(PGA)、聚(乳酸)(PLA)、聚己内酯(PCL)、聚二氧杂环己酮(PDO)和它们的共聚物。非合成聚合物的示例包括但不限于多糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和氧化再生纤维素(ORC)。任选地,类似于本文在别处所述的聚合物组合物,补偿层60122的聚合物组合物可包含量不同(例如按重量百分比计)的可吸收的聚合物、不可吸收的聚合物、合成聚合物和或非合成聚合物。任选地,组织厚度补偿件60120中的每个补偿层60022可包含不同的聚合物组合物,或作为另外一种选择,至少两个补偿层60122可包含相同的聚合物组合物。Still referring to FIG. 160, for example, the compensation layer 60122 and the support beams 60124 of the tissue thickness compensator 60120 can comprise different materials, such as structured materials, biological materials, and/or electrical materials. For example, at least one compensation layer 60122 may comprise a polymer composition. The polymer composition may comprise an at least partially elastic material such that deformation of the compensating layer 60122 and/or support beams 60124 may generate a resilient force. The polymer composition of the compensation layer 60122 may comprise non-absorbable polymers, absorbable polymers, or combinations thereof. For example, absorbable polymers can include bioabsorbable biocompatible elastomeric polymers. Additionally, the polymer composition of the compensation layer 60122 can include synthetic polymers, non-synthetic polymers, or combinations thereof. Examples of synthetic polymers include, but are not limited to, polyglycolic acid (PGA), poly(lactic acid) (PLA), polycaprolactone (PCL), polydioxanone (PDO), and copolymers thereof. Examples of non-synthetic polymers include, but are not limited to, polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and oxidized regenerated cellulose (ORC). Optionally, similar to the polymer compositions described elsewhere herein, the polymer composition of the compensation layer 60122 may comprise absorbable polymers, nonabsorbable polymers, synthetic Polymers and or non-synthetic polymers. Optionally, each compensation layer 60022 in the tissue thickness compensator 60120 can comprise a different polymer composition, or alternatively, at least two compensation layers 60122 can comprise the same polymer composition.
再次参见图159,例如,至少一个补偿层60022可包含治疗剂60098,诸如药物或药物活性剂。补偿层60022可释放治疗有效量的治疗剂60098。治疗剂60098可在补偿层60022被吸收时释放。治疗剂60098的示例可包括但不限于止血剂和药物,诸如,血纤维蛋白、凝血酶和/或氧化再生纤维素(ORC);抗炎剂药物,诸如双氯芬酸、阿司匹林、萘普生、舒林酸和/或氢化可的松;抗生素和抗微生物药物或抗微生物剂,诸如三氯生、离子银、氨苄青霉素、庆大霉素、多粘菌素B、和/或氯霉素;和/或抗癌剂,诸如顺铂、丝裂霉素和/或阿霉素。例如,治疗剂60098可包含生物制剂,诸如干细胞。任选地,组织厚度补偿件60020中的每个补偿层60022可包含不同的治疗剂60098,或作为另外一种选择,至少两个补偿层60022可包含相同的治疗剂60098。例如,包含治疗剂60098(诸如生物制剂)的补偿层60022例如可包裹在两个结构化补偿层60022之间,所述两个结构化补偿层包含聚合物组合物,诸如聚乙醇酸(PGA)泡沫。根据本发明,补偿层60022可还包含例如导电材料,诸如铜。Referring again to FIG. 159, for example, at least one compensation layer 60022 can comprise a therapeutic agent 60098, such as a drug or pharmaceutically active agent. The compensation layer 60022 can release a therapeutically effective amount of the therapeutic agent 60098. The therapeutic agent 60098 can be released when the compensation layer 60022 is absorbed. Examples of therapeutic agents 60098 may include, but are not limited to, hemostatic agents and drugs such as fibrin, thrombin, and/or oxidized regenerated cellulose (ORC); anti-inflammatory agent drugs such as diclofenac, aspirin, naproxen, sulindac acid and/or hydrocortisone; antibiotics and antimicrobials or antimicrobial agents such as triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, and/or chloramphenicol; and/or or anticancer agents such as cisplatin, mitomycin and/or doxorubicin. For example, Therapeutic Agent 60098 may comprise a biological agent, such as stem cells. Optionally, each compensation layer 60022 in the tissue thickness compensator 60020 can comprise a different therapeutic agent 60098, or alternatively at least two compensation layers 60022 can comprise the same therapeutic agent 60098. For example, a compensation layer 60022 comprising a therapeutic agent 60098, such as a biologic, can be wrapped, for example, between two structured compensation layers 60022 comprising a polymer composition such as polyglycolic acid (PGA) Foam. According to the invention, the compensation layer 60022 may also comprise, for example, a conductive material such as copper.
再次参见图174,组织厚度补偿件62020中的补偿层62022可具有不同的几何形状。当层62022相邻地定位在组织厚度补偿件62020中时,补偿层62022可在层62022之间形成至少一个三维导管62032。例如,当包括通道的第二补偿层62022b被定位在基本上平坦的第三补偿层62022c的上方时,第三补偿层62022c的通道和平坦表面可限定两者间的三维导管62032a。相似地,例如,当包括通道的第五补偿层62022e被定位在包括对应通道的第四补偿层62022d的下方时,所述通道可形成由邻近叠堆的补偿层62022d、62022e中的通道限定的三维导管62032b。当流体流过组织厚度补偿件62020时,导管62032可以引导治疗剂和/或体液。Referring again to FIG. 174, the compensation layer 62022 in the tissue thickness compensator 62020 can have different geometries. When the layers 62022 are adjacently positioned in the tissue thickness compensator 62020, the compensating layers 62022 can form at least one three-dimensional conduit 62032 between the layers 62022. For example, when a second compensation layer 62022b including channels is positioned over a third substantially planar compensation layer 62022c, the channels and planar surface of the third compensation layer 62022c can define a three-dimensional conduit 62032a therebetween. Similarly, for example, when a fifth compensation layer 62022e comprising a channel is positioned below a fourth compensation layer 62022d comprising a corresponding channel, the channel may form a channel defined by channels in adjacent stacked compensation layers 62022d, 62022e. 3D Catheter 62032b. Conduit 62032 may direct therapeutic agents and/or bodily fluids as fluid flows through tissue thickness compensator 62020 .
参见图170,组织厚度补偿件61020可包括补偿层61022,诸如层60122a和21022b,所述层能够接收从钉仓20000(图169)中部署的钉30030。当钉30030从初始位置运动到击发位置时,至少一个补偿层61022的几何形状可将钉腿30032引导至击发位置。任选地,至少一个补偿层61022可包括延伸穿过其中的孔61030,其中孔61030可被布置为在钉30030从钉仓20000(图169)中被击发时接收已部署钉30030的钉腿30032,如本文更详细地描述。作为另外一种选择,再次参见图174,例如,钉腿30032可以刺穿至少一个补偿层,诸如补偿层62022f,并且可通过孔62030被接收在至少一个补偿层中,诸如补偿层62022a。Referring to Fig. 170, the tissue thickness compensator 61020 can include compensating layers 61022, such as layers 60122a and 21022b, which are configured to receive the staples 30030 deployed from the staple cartridge 20000 (Fig. 169). As the staples 30030 are moved from the initial position to the fired position, the geometry of the at least one compensating layer 61022 can guide the staple legs 30032 to the fired position. Optionally, the at least one compensation layer 61022 can include holes 61030 extending therethrough, wherein the holes 61030 can be arranged to receive the staple legs 30032 of the deployed staples 30030 when the staples 30030 are fired from the staple cartridge 20000 ( FIG. 169 ) , as described in more detail herein. Alternatively, referring again to FIG. 174, for example, staple legs 30032 can pierce at least one compensation layer, such as compensation layer 62022f, and can be received in at least one compensation layer, such as compensation layer 62022a, through holes 62030.
主要参见图170,组织厚度补偿件60120可包括补偿层61022a、61022b中的一者上的至少一个支撑插片61026。支撑插片61026可突起进入限定在相邻补偿层之间的分离间隙61032,诸如第一补偿层61020a和第二补偿层61020b之间的间隙61032。支撑插片61026可从第一补偿层61022a的纵向侧突起。此外,支撑插片61026可沿纵向侧的长度延伸或仅沿其一部分延伸。任选地,至少一个支撑插片61026可从补偿层61022a、61022b的两个纵向侧突起。另外,相邻定位的补偿层61022a、61022b可包括对应的支撑插片60126,使得从第一补偿层60122a延伸的支撑插片60126可至少部分地与从第二补偿层60122b延伸的支撑插片60126对齐。再次参见图168,组织厚度补偿件60820可包括位于相邻补偿层60122a、60122b之间的限制器板60828。例如,限制器板60828可定位在限定于第一补偿层60122a和第二补偿层60122b之间的间隙60132中。如本文更详细地描述,支撑插片61026和/或限制器板60828可控制支撑件60124和/或补偿层60122a、60122b的变形和/或偏转。Referring primarily to FIG. 170, the tissue thickness compensator 60120 can include at least one support tab 61026 on one of the compensating layers 61022a, 61022b. The support tabs 61026 can protrude into separation gaps 61032 defined between adjacent compensation layers, such as the gap 61032 between the first compensation layer 61020a and the second compensation layer 61020b. The support tabs 61026 can protrude from the longitudinal sides of the first compensation layer 61022a. Additionally, the support tabs 61026 may extend along the length of the longitudinal sides or along only a portion thereof. Optionally, at least one support tab 61026 can protrude from both longitudinal sides of the compensation layer 61022a, 61022b. Additionally, adjacently positioned compensation layers 61022a, 61022b can include corresponding support tabs 60126 such that support tabs 60126 extending from a first compensation layer 60122a can at least partially align with support tabs 60126 extending from a second compensation layer 60122b. align. Referring again to FIG. 168, the tissue thickness compensator 60820 can include a restrictor plate 60828 positioned between adjacent compensating layers 60122a, 60122b. For example, the restrictor plate 60828 can be positioned in the gap 60132 defined between the first compensation layer 60122a and the second compensation layer 60122b. As described in greater detail herein, the support tabs 61026 and/or the limiter plates 60828 can control deformation and/or deflection of the supports 60124 and/or compensating layers 60122a, 60122b.
如本文所述,组织厚度补偿件60020的补偿层60022可包含不同的材料、几何形状和/或尺寸。此类组织厚度补偿件60020可通过多种制造技术组装。主要参见图159,组织厚度补偿件60022可通过平版印刷、立体光刻(SLA)或丝网印刷工艺来制造。例如,立体光刻制造工艺可形成组织厚度补偿件60020,其中每个补偿层60022包含不同的材料和/或几何形特征结构。例如,立体光刻机中的紫外光可绘制第一补偿层60022的几何形状,使得包含第一材料、几何形状和/或尺寸的第一补偿层60022通过紫外光固化。紫外光可随后绘制第二补偿层60022的几何形状,使得包含第二材料、几何形状和/或尺寸的第二补偿层60022通过紫外光固化。根据本发明,立体光刻机可以在彼此顶部上绘制补偿层60022、并排绘制补偿层60022、或以它们的组合绘制补偿层60022。此外,补偿层60022可被绘制为使得凹坑60132存在于相邻的补偿层60022之间。由于立体光刻机可形成具有独特的几何形状的非常薄的层,因此由立体光刻工艺制造的组织厚度补偿件60020可包括非常复杂的三维几何形状。As described herein, the compensation layers 60022 of the tissue thickness compensator 60020 can comprise different materials, geometries, and/or dimensions. Such tissue thickness compensators 60020 can be assembled by a variety of manufacturing techniques. Referring primarily to FIG. 159, the tissue thickness compensator 60022 can be fabricated by lithography, stereolithography (SLA), or screen printing processes. For example, a stereolithographic fabrication process can form a tissue thickness compensator 60020 in which each compensation layer 60022 comprises different materials and/or geometrical features. For example, ultraviolet light in a stereolithography machine can map the geometry of the first compensation layer 60022 such that the first compensation layer 60022 comprising a first material, geometry and/or size is cured by ultraviolet light. The UV light can then map the geometry of the second compensation layer 60022 such that the second compensation layer 60022 comprising a second material, geometry and/or size is cured by the UV light. According to the present invention, the stereolithography machine can draw the compensation layers 60022 on top of each other, side by side, or a combination thereof. In addition, the compensation layers 60022 may be drawn such that pits 60132 exist between adjacent compensation layers 60022 . Since a stereolithography machine can form very thin layers with unique geometries, the tissue thickness compensator 60020 fabricated by the stereolithography process can include very complex three-dimensional geometries.
参见图169,组织厚度补偿件60920可定位在外科器械10的端部执行器12中(图1)。组织厚度补偿件60920可相对于端部执行器12的钉仓20000定位。例如,组织厚度补偿件60920可以可释放地固定到钉仓20000。组织厚度补偿件60920的至少一个补偿层60922可邻近钉仓20000的顶部平台表面20011(图79)定位。例如,第二补偿层60922b可通过粘合剂或通过包裹物(与本文所述的包裹物中的至少一者类似)(图16)固定到顶部平台表面20011。组织厚度补偿件60920可与钉仓20000成一整体,使得钉仓20000和组织厚度补偿件60920形成为单个单元构造。例如,钉仓20000可包括第一主体部分,诸如刚性支撑部分20010(图79),和第二主体部分,诸如组织厚度补偿件60920。Referring to FIG. 169, a tissue thickness compensator 60920 can be positioned within the end effector 12 of the surgical instrument 10 (FIG. 1). The tissue thickness compensator 60920 can be positioned relative to the staple cartridge 20000 of the end effector 12 . For example, tissue thickness compensator 60920 can be releasably secured to staple cartridge 20000. At least one compensation layer 60922 of the tissue thickness compensator 60920 can be positioned adjacent to the top deck surface 20011 of the staple cartridge 20000 ( FIG. 79 ). For example, the second compensation layer 60922b may be secured to the top deck surface 20011 by an adhesive or by a wrap (similar to at least one of the wraps described herein) ( FIG. 16 ). The tissue thickness compensator 60920 can be integral with the staple cartridge 20000 such that the staple cartridge 20000 and the tissue thickness compensator 60920 are formed as a single unit configuration. For example, staple cartridge 20000 can include a first body portion, such as rigid support portion 20010 ( FIG. 79 ), and a second body portion, such as tissue thickness compensator 60920 .
仍然参见图169,组织厚度补偿件60920可包括第一补偿件部分60920a和第二补偿件部分60920b。第一补偿件部分60920a可定位在钉仓20000的第一纵向侧上,并且第二补偿件部分60920b可定位在钉仓20000的第二纵向侧上。任选地,当组织厚度补偿件60920相对于钉仓20000定位时,刚性支撑部分20010(图78)中的纵向狭槽20015(图78)可在第一补偿件部分60920a和第二补偿件部分60920b之间延伸。例如,当钉击发滑动件20050(图78)上的切割元件20052平移穿过端部执行器12时,切割元件20052可穿过第一补偿件部分60920a和第二补偿件部分60920b之间的纵向狭槽20015,而不切断组织厚度补偿件60920的一部分。作为另外一种选择,切割元件20052能够切断组织厚度补偿件60920的一部分。Still referring to FIG. 169, the tissue thickness compensator 60920 can include a first compensator portion 60920a and a second compensator portion 60920b. The first compensator portion 60920a can be positioned on a first longitudinal side of the staple cartridge 20000 and the second compensator portion 60920b can be positioned on a second longitudinal side of the staple cartridge 20000 . Optionally, when the tissue thickness compensator 60920 is positioned relative to the staple cartridge 20000, the longitudinal slot 20015 (FIG. 78) in the rigid support portion 20010 (FIG. 78) can be positioned between the first compensator portion 60920a and the second compensator portion. 60920b extends between. For example, when the cutting element 20052 on the staple firing sled 20050 (FIG. 78) is translated through the end effector 12, the cutting element 20052 can pass through the longitudinal direction between the first compensator portion 60920a and the second compensator portion 60920b. slot 20015 without cutting a portion of the tissue thickness compensator 60920. Alternatively, cutting element 20052 can sever a portion of tissue thickness compensator 60920 .
现在参见图162,组织厚度补偿件63020能够适配在圆形外科器械的端部执行器12’中。组织厚度补偿件62030可包括圆形的第一补偿层63022a和圆形的第二补偿层63022b。第二补偿层63022b可定位在圆形钉仓20000’的圆形顶部平台表面20011’上,其中第二补偿层63022b可包括对应于平台表面20011’的几何形状的几何形状。例如,平台表面20011’可包括阶梯部分,并且第二补偿层63022b可包括对应的阶梯部分。组织厚度补偿件还可包括,例如,围绕组织厚度补偿件63020延伸的至少一个支撑件63024和/或支撑插片63026。Referring now to FIG. 162, a tissue thickness compensator 63020 can be fitted within the end effector 12' of a circular surgical instrument. The tissue thickness compensator 62030 can include a circular first compensation layer 63022a and a circular second compensation layer 63022b. A second compensation layer 63022b can be positioned on the circular top deck surface 20011' of the circular staple cartridge 20000', wherein the second compensation layer 63022b can include a geometry corresponding to the geometry of the deck surface 20011'. For example, the mesa surface 20011' may include a stepped portion, and the second compensation layer 63022b may include a corresponding stepped portion. The tissue thickness compensator can also include, for example, at least one support member 63024 and/or support tabs 63026 extending around the tissue thickness compensator 63020 .
再次参见图170,击发钉30030能够接合组织厚度补偿件60920。如本公开通篇所述的那样,击发钉30030可捕获组织厚度补偿件60920的一部分和组织T,并且将压缩力施加到组织厚度补偿件60920。另外,主要参见图171-图173,组织厚度补偿件60920可为可变形的。任选地,如本文所述,第一补偿层60920a可通过分离间隙60932与第二补偿层60920b分开。参见图171,在压缩组织厚度补偿件60920之前,间隙60932可包括第一距离。当例如通过击发钉30030(图170)将压缩力A施加到组织厚度补偿件60920和组织T时,支撑件60924能够变形。现在参见图172,单弯曲支撑梁60924可在压缩力A下弯曲,使得第一补偿层60920a和第二补偿层60920b之间的分离间隙60932减小到第二距离。主要参见图173,第一补偿层60922a和第二补偿层60922b也可在压缩力A下变形。支撑插片60926可以控制补偿层60920的变形。例如,支撑插片60926可以通过在补偿层60920彼此接触时支撑其纵向侧而防止补偿层60920的过度弯曲。支撑插片60926也能够在压缩力A下弯曲或成弓形。除此之外或作为另外一种选择,当补偿层60920和/或支撑插片60926接触限制器板60128时,在本文中更详细描述的限制器板60128(图168)可以限制补偿层60920的变形。Referring again to FIG. 170 , the fired staples 30030 can be configured to engage the tissue thickness compensator 60920 . As described throughout this disclosure, the fired staples 30030 can capture a portion of the tissue thickness compensator 60920 and the tissue T and apply a compressive force to the tissue thickness compensator 60920 . Additionally, referring primarily to FIGS. 171-173 , the tissue thickness compensator 60920 can be deformable. Optionally, the first compensation layer 60920a can be separated from the second compensation layer 60920b by a separation gap 60932 as described herein. Referring to FIG. 171 , prior to compressing the tissue thickness compensator 60920 , the gap 60932 can comprise a first distance. When a compressive force A is applied to the tissue thickness compensator 60920 and the tissue T, eg, by firing the staples 30030 (FIG. 170), the struts 60924 are capable of deforming. Referring now to FIG. 172, the single bend support beam 60924 can bend under a compressive force A such that the separation gap 60932 between the first compensation layer 60920a and the second compensation layer 60920b is reduced to a second distance. Referring primarily to FIG. 173, the first compensation layer 60922a and the second compensation layer 60922b are also deformable under compressive force A. The support tabs 60926 can control the deformation of the compensation layer 60920 . For example, the support tabs 60926 can prevent excessive bending of the compensation layers 60920 by supporting the longitudinal sides of the compensation layers 60920 when they contact each other. Support tab 60926 is also capable of bending or bowing under compressive force A. Additionally or alternatively, the limiter plate 60128 ( FIG. 168 ), described in greater detail herein, can limit the movement of the compensation layer 60920 when the compensation layer 60920 and/or the support tab 60926 contacts the limiter plate 60128 . out of shape.
此外,类似于本文所述的各种组织厚度补偿件,组织厚度补偿件60920可在变形时产生回弹力或恢复力。变形的组织厚度补偿件产生的恢复力可至少部分地取决于组织厚度补偿件60920的取向、尺寸、材料和/或几何形状,以及因所施加的力而变形的组织厚度补偿件60920的量。此外,组织厚度补偿件60920的至少一部分可具有弹性,使得组织厚度补偿件60920在通过击发钉30030变形时产生弹簧负载或恢复力。支撑件60924可包括弹性材料和/或至少一个补偿层60922可包括弹性材料,使得组织厚度补偿件60920具有弹性。In addition, similar to the various tissue thickness compensators described herein, the tissue thickness compensator 60920 can generate a resilient or restoring force when deformed. The restoring force produced by the deformed tissue thickness compensator may depend, at least in part, on the orientation, size, material, and/or geometry of the tissue thickness compensator 60920, as well as the amount of the tissue thickness compensator 60920 deformed by the applied force. Additionally, at least a portion of the tissue thickness compensator 60920 can be resilient such that the tissue thickness compensator 60920 generates a spring load or restoring force when deformed by firing the staples 30030 . The support 60924 can comprise an elastic material and/or the at least one compensating layer 60922 can comprise an elastic material such that the tissue thickness compensator 60920 is elastic.
现在参见图175,外科缝合器械的端部执行器可包括第一钳口和第二钳口,其中第一钳口和第二钳口中的至少一者能够相对于彼此移动。例如,端部执行器可具有包括钉仓通道19070的第一钳口和包括砧座19060的第二钳口,其中砧座19060可朝向和/或远离钉仓通道19070枢转。钉仓通道19070能够接收钉仓19000,例如,其可以可移除地保持在钉仓通道19070中。钉仓19000可包括仓体19010和组织厚度补偿件19020,其中组织厚度补偿件19020可以可移除地附接到仓体19010。现在参见图176,仓体19010可包括多个钉腔19012和定位在每个钉腔19012中的钉19030。另外,钉19030可由定位在仓体19010内的钉驱动器19040支撑,其中滑动件和/或击发构件例如可被推进穿过钉仓19000以向上提升钉腔19012内的钉驱动器19040,如图177所示,并且从钉腔19012中射出钉19030。Referring now to FIG. 175, an end effector of a surgical stapling instrument can include a first jaw and a second jaw, wherein at least one of the first jaw and the second jaw is movable relative to each other. For example, an end effector can have a first jaw including a staple cartridge channel 19070 and a second jaw including an anvil 19060 , wherein the anvil 19060 can pivot toward and/or away from the staple cartridge channel 19070 . The staple cartridge channel 19070 is capable of receiving a staple cartridge 19000 , which may be removably retained therein, for example. The staple cartridge 19000 can include a cartridge body 19010 and a tissue thickness compensator 19020 , wherein the tissue thickness compensator 19020 can be removably attached to the cartridge body 19010 . Referring now to FIG. 176 , a cartridge body 19010 can include a plurality of staple cavities 19012 and a staple 19030 positioned in each staple cavity 19012 . Additionally, the staples 19030 can be supported by staple drivers 19040 positioned within the cartridge body 19010, wherein a sled and/or firing member can be advanced through the staple cartridge 19000, for example, to lift the staple drivers 19040 upwardly within the staple cavity 19012, as shown in FIG. 177 shown, and the staples 19030 are ejected from the staple cavities 19012.
主要参见图175和图176,组织厚度补偿件19020可包括弹性构件19022和封装弹性构件19022的容器19024。容器19024可被密封并且可以限定包含内部气体的腔体,该内部气体具有不同于周围大气压强的压强。内部气体的压强可以大于周围大气的压强,而作为另外一种选择,内部气体的压强可以小于周围大气的压强。在其中容器19024包含小于周围大气压强的压强的实施例中,容器19024的侧壁可以包围真空。在这种情况下,所述真空可以导致容器19024变形、塌缩和/或平化,其中定位在容器19024内的弹性构件19022可被弹性压缩在容器19024内。当在容器19024上抽取真空时,弹性构件19022可以向下偏转或变形并且可在压缩或真空密封状态下通过容器19024的侧壁保持就位。Referring primarily to FIGS. 175 and 176 , a tissue thickness compensator 19020 can include a resilient member 19022 and a container 19024 enclosing the resilient member 19022 . The container 19024 can be sealed and can define a cavity containing an internal gas having a pressure different from the surrounding atmospheric pressure. The pressure of the internal gas may be greater than the pressure of the surrounding atmosphere, or alternatively the pressure of the internal gas may be less than the pressure of the surrounding atmosphere. In embodiments where the container 19024 contains a pressure less than the surrounding atmospheric pressure, the side walls of the container 19024 may enclose a vacuum. In such a case, the vacuum may cause deformation, collapse, and/or flattening of the container 19024 , wherein the resilient member 19022 positioned within the container 19024 may be elastically compressed within the container 19024 . When a vacuum is drawn on the container 19024, the resilient member 19022 can deflect or deform downward and can be held in place by the sidewall of the container 19024 in a compressed or vacuum-tight state.
弹性构件19022和容器19024由生物相容性材料构成。任选地,例如,弹性构件19022和/或容器19024可由可生物吸收的材料(诸如PLLA、PGA和/或PCL)构成。弹性构件19022可由弹性材料构成。弹性构件19022也可包括结构化弹性。例如,弹性构件19022可为中空管的形式。Resilient member 19022 and container 19024 are constructed of a biocompatible material. Optionally, elastic member 19022 and/or container 19024 may be constructed of a bioabsorbable material such as PLLA, PGA, and/or PCL, for example. The elastic member 19022 can be composed of an elastic material. The elastic member 19022 can also include structural elastic. For example, elastic member 19022 may be in the form of a hollow tube.
对上文进行进一步描述,组织厚度补偿件19020可以抵靠或邻近仓体19010的平台表面19011定位。现在参见图177,当钉19030至少部分地被击发时,钉19030的腿可以刺穿容器19024或使其破裂。容器19024可包括中心部分19026,该中心部分可定位在仓体19010的切割狭槽19016的上方,使得当切割构件19080推进至切割定位在钉仓19000和砧座19060之间的组织T时,切割构件19080也可切割容器19024的中心部分19026,从而刺穿容器19024或使其破裂。在任一种情况下,一旦容器19024已经破裂,则容器19024内的内部气体可与围绕组织厚度补偿件19020的大气取得平衡,并且允许弹性构件19022弹性膨胀,以重新获取或至少部分地重新获取其未变形和/或未平化的构型。在这种情况下,弹性构件19022可将偏置力施加到被捕获在变形的钉19020内的组织T。更具体地讲,在通过限定在砧座19060中的凹坑19062的成形表面变形之后,钉19030的腿可以将组织T和弹性构件19022的至少一部分捕获在钉19030内,使得当容器19024破裂时,组织厚度补偿件19020可以补偿被捕获在钉19030内的组织T的厚度。例如,当被捕获在钉19030内的组织T较薄时,被捕获在该钉19030内的弹性构件19022可以膨胀以填充钉19030内的间隙,并且将足够的压缩力施加到组织T。相应地,当被捕获在钉19030内的组织T较厚时,被捕获在该钉19030内的弹性构件19022可保持压缩以为钉19030内的较厚组织让出空间,并且同样,将足够的压缩力施加到组织T。Further to the above, the tissue thickness compensator 19020 can be positioned against or adjacent to the deck surface 19011 of the cartridge body 19010 . Referring now to FIG. 177, when the staples 19030 are at least partially fired, the legs of the staples 19030 can pierce or rupture the container 19024. Receptacle 19024 can include a central portion 19026 that can be positioned over cutting slot 19016 of cartridge body 19010 such that when cutting member 19080 is advanced to cut tissue T positioned between staple cartridge 19000 and anvil 19060, the cutting Member 19080 may also cut central portion 19026 of container 19024, thereby piercing or rupturing container 19024. In either case, once the container 19024 has ruptured, the internal gas within the container 19024 can equilibrate with the atmosphere surrounding the tissue thickness compensator 19020 and allow the resilient member 19022 to elastically expand to recapture, or at least partially recapture, its Undeformed and/or unflattened configuration. In such instances, the resilient members 19022 can apply a biasing force to the tissue T captured within the deformed staples 19020 . More specifically, the legs of the staples 19030 can capture the tissue T and at least a portion of the resilient member 19022 within the staples 19030 after being deformed by the forming surface of the dimples 19062 defined in the anvil 19060 such that when the container 19024 ruptures , the tissue thickness compensator 19020 can compensate for the thickness of tissue T captured within the staples 19030 . For example, when the tissue T captured within the staple 19030 is thin, the resilient member 19022 captured within the staple 19030 can expand to fill the gap within the staple 19030 and apply a sufficient compressive force to the tissue T. Accordingly, when the tissue T captured within the staple 19030 is thicker, the resilient member 19022 captured within the staple 19030 can remain compressed to make room for the thicker tissue within the staple 19030 and, likewise, compress sufficiently A force is applied to the tissue T.
当容器19024被刺穿时,如上所述,弹性构件19022可以试图膨胀以弹性返回到其初始构型。在某些情况下,已被捕获在钉19030内的弹性构件19022的一部分可能无法返回到其初始未变形形状。在这种情况下,弹性构件19022可包括弹簧,该弹簧可将压缩力施加到被捕获在钉19030内的组织T。根据本发明,弹性构件19022可以模拟线性弹簧,其中由弹性构件19022施加的压缩力与量或距离线性成比例,其中弹性构件19022保持在钉19030内偏转。作为另外一种选择,弹性构件19022可以模拟非线性弹簧,其中由弹性构件19022施加的压缩力不与量或距离线性成比例,其中弹性构件19022保持在钉19030内偏转。When the container 19024 is pierced, the resilient member 19022 may attempt to expand to resiliently return to its original configuration, as described above. In some instances, a portion of resilient member 19022 that has been captured within staple 19030 may fail to return to its original, undeformed shape. In this case, the resilient member 19022 can comprise a spring that can apply a compressive force to the tissue T captured within the staple 19030 . In accordance with the present invention, the elastic member 19022 may emulate a linear spring, wherein the compressive force exerted by the elastic member 19022 is linearly proportional to the amount or distance that the elastic member 19022 remains deflected within the staple 19030 . Alternatively, the elastic member 19022 may emulate a non-linear spring, where the compressive force exerted by the elastic member 19022 is not linearly proportional to the amount or distance in which the elastic member 19022 remains deflected within the staple 19030 .
主要参见图178和图179,钉仓19200可包括组织厚度补偿件19220,该组织厚度补偿件可在其中包括一个或多个密封的容器19222。容器19222中的每一个可被密封并且可包含内部气体。密封容器19222内的内部气体的压强可以超过大气压强,而密封容器19222内的内部气体的压强可以低于大气压强。在容器19222内的内部气体的压强低于大气压强的情况下,容器19222可被描述为包含真空。任选地,例如,一个或多个容器19222可被包裹或包含在外护套、箱、包裹物和/或膜19224中,其中组织厚度补偿件19220可被定位在仓体19010的平台表面19011上方。例如,每个容器19222可由具有圆形或至少基本上圆形横截面(例如,具有闭合端和开口端)的管制成。可在管的开口端上抽取真空,并且当在管内达到足够的真空时,开口端可被闭合和密封。例如,管可由例如聚合物材料构成,其中管的开口端可被热熔以闭合和密封该开口端。在任何情况下,每个容器19222内的真空可以向内牵拉管的侧壁并且使管弹性变形和/或平化。容器19222被示出为在图179中处于至少部分平化的状态。Referring primarily to FIGS. 178 and 179 , a staple cartridge 19200 can include a tissue thickness compensator 19220 that can include one or more sealed containers 19222 therein. Each of the containers 19222 may be sealed and may contain an internal gas. The pressure of the gas inside the sealed container 19222 may exceed atmospheric pressure, while the pressure of the gas inside the sealed container 19222 may be lower than atmospheric pressure. Where the pressure of the internal gas within the vessel 19222 is below atmospheric pressure, the vessel 19222 may be described as containing a vacuum. Optionally, for example, one or more containers 19222 can be wrapped or contained in an outer sheath, box, wrap and/or membrane 19224, wherein the tissue thickness compensator 19220 can be positioned above the deck surface 19011 of the cartridge body 19010 . For example, each container 19222 can be fabricated from a tube having a circular or at least substantially circular cross-section (eg, having a closed end and an open end). A vacuum can be drawn on the open end of the tube, and when a sufficient vacuum is achieved within the tube, the open end can be closed and sealed. For example, the tube may be constructed of, for example, a polymeric material, wherein the open end of the tube may be heat fused to close and seal the open end. In any event, the vacuum within each container 19222 can pull the sidewalls of the tube inward and elastically deform and/or flatten the tube. Container 19222 is shown in FIG. 179 in an at least partially flattened state.
当钉19030处于其未击发位置时,如图179所示,钉19030的顶端可被定位在组织厚度补偿件19220下方。例如,钉19030可被定位在其各自的钉腔19012内,使得钉19030不与容器19222接触,直到钉19030从图179所示的未击发位置运动到图180所示的其击发位置。组织厚度补偿件19220的包裹物19224可以保护容器19220不被钉19030过早地刺穿。现在参见图180,当钉19030被至少部分地击发时,钉19030的腿可以刺穿容器19222或使其破裂。在这种情况下,容器19222内的内部气体可与容器19222周围的大气取得平衡,并且弹性膨胀以重新获取、或至少部分地重新获取其未变形的和/或未平化的构型。在这种情况下,被刺穿的容器19222可将偏置力施加到被捕获在变形的钉19030内的组织。更具体地讲,在通过限定在砧座19060中的凹坑19062的成形表面变形之后,钉19030的腿可以将组织T和容器19222的至少一部分捕获在钉19030内,使得当容器19222破裂时,容器19222可以补偿被捕获在钉19030内的组织T的厚度。例如,当被捕获在钉19030内的组织T较薄时,被捕获在该钉19030内的容器19222可以膨胀以填充钉19030内的间隙,并且同时将足够的压缩力施加到组织T。相应地,当被捕获在钉19030内的组织T较厚时,被捕获在该钉19030内的容器19222可保持压缩以为钉19030内的较厚组织让出空间,并且同时将足够的压缩力施加到组织T。When the staples 19030 are in their unfired positions, as shown in FIG. 179 , the tips of the staples 19030 can be positioned below the tissue thickness compensator 19220 . For example, the staples 19030 can be positioned within their respective staple cavities 19012 such that the staples 19030 do not contact the receptacle 19222 until the staples 19030 are moved from their unfired position shown in FIG. 179 to their fired position shown in FIG. 180 . The wrapping 19224 of the tissue thickness compensator 19220 can protect the container 19220 from being prematurely pierced by the staples 19030. Referring now to FIG. 180, when the staples 19030 are at least partially fired, the legs of the staples 19030 can pierce or rupture the container 19222. In such a case, the internal gas within the container 19222 may equilibrate with the atmosphere surrounding the container 19222 and elastically expand to regain, or at least partially regain, its undeformed and/or unflattened configuration. In this case, the pierced container 19222 can apply a biasing force to tissue captured within the deformed staple 19030 . More specifically, the legs of the staples 19030 can capture the tissue T and at least a portion of the container 19222 within the staples 19030 after being deformed by the forming surface of the recess 19062 defined in the anvil 19060 such that when the container 19222 ruptures, Receptacles 19222 can compensate for the thickness of tissue T captured within staples 19030. For example, when the tissue T captured within the staple 19030 is thin, the receptacle 19222 captured within the staple 19030 can expand to fill the gap within the staple 19030 while applying sufficient compressive force to the tissue T. Accordingly, when the tissue T captured within the staple 19030 is thicker, the receptacle 19222 captured within the staple 19030 can remain compressed to make room for the thicker tissue within the staple 19030 while applying sufficient compressive force to organization T.
当容器19222被刺穿时,如上所述,容器19222可以试图膨胀以弹性返回到其初始构型。容器19222的已被捕获在钉19030内的部分可能无法返回到其初始未变形形状。在这种情况下,容器19222可包括弹簧,该弹簧可将压缩力施加到被捕获在钉19030内的组织T。根据本发明,容器19222可以模拟线性弹簧,其中由容器19222施加的压缩力与量或距离线性成比例,其中容器19222保持在钉19030内偏转。作为另外一种选择,容器19222可以模拟非线性弹簧,其中由容器19222施加的压缩力不与量或距离线性成比例,其中容器19222保持在钉19030内偏转。容器19222在其处于其密封构型下时可为中空的和空的。作为另外一种选择,容器19222中的每一个可限定腔体,并且还可包括其中包含的至少一种药物。例如,容器19222可包含至少一种药物,该至少一种药物可被释放和/或生物吸收。When the container 19222 is pierced, as described above, the container 19222 may attempt to expand to resiliently return to its original configuration. Portions of the container 19222 that have been captured within the staples 19030 may not return to their original, undeformed shape. In such cases, the receptacle 19222 can include a spring that can apply a compressive force to the tissue T captured within the staples 19030 . In accordance with the present invention, the container 19222 may emulate a linear spring, wherein the compressive force exerted by the container 19222 is linearly proportional to the amount or distance that the container 19222 remains deflected within the peg 19030 . Alternatively, the container 19222 may emulate a non-linear spring, where the compressive force exerted by the container 19222 is not linearly proportional to the amount or distance in which the container 19222 remains deflected within the staple 19030 . The container 19222 can be hollow and empty when it is in its sealed configuration. Alternatively, each of containers 19222 can define a cavity, and can also include at least one medicament contained therein. For example, container 19222 can contain at least one drug that can be released and/or bioabsorbed.
可以任何合适的方式来布置组织厚度补偿件19220的容器19222。如图178所示,限定在仓体19010中的钉腔19012,和定位在钉腔19012中的钉19030可成行布置。如图所示,例如,钉腔19012可被布置成六个纵向线性的行;然而,可利用钉腔19012的任何合适布置方式。还如图178所示,组织厚度补偿件19220可包括六个容器19222,其中容器19222中的每一个可与一行钉腔19012对齐,或定位在其上方。一行钉腔19012内的钉19030中的每一个能够刺穿相同的容器19222。在某些情况下,钉19030的钉腿中的一些可不刺穿定位在其上的容器19222;然而,在容器19222限定连续内腔的情况下,例如,可通过钉19030中的至少一个充分地刺穿腔体,以便允许内腔气体的压力与容器19222周围的大气压力取得平衡。现在参见图185,组织厚度补偿件例如可包括容器,诸如容器19222’,其可沿横向于钉线19030的方向延伸。例如,容器19222’可横跨多个钉行延伸。现在参见图186,组织厚度补偿件19220”可包括多个容器19222”,其沿垂直于或至少基本上垂直于钉线19030的方向延伸。例如,容器19222”的一些可被钉19030刺穿,而另一些可以不被钉19030刺穿。例如,容器19222”可以横跨或穿过切割路径延伸,其中切割构件可横切容器19222”并使其破裂。The receptacle 19222 of the tissue thickness compensator 19220 may be arranged in any suitable manner. As shown in FIG. 178, the staple cavities 19012 defined in the cartridge body 19010, and the staples 19030 positioned in the staple cavities 19012 can be arranged in rows. As shown, for example, the staple cavities 19012 can be arranged in six longitudinal linear rows; however, any suitable arrangement of the staple cavities 19012 can be utilized. As also shown in FIG. 178 , the tissue thickness compensator 19220 can include six receptacles 19222 , wherein each of the receptacles 19222 can be aligned with, or positioned over, a row of staple cavities 19012 . Each of the staples 19030 within a row of staple cavities 19012 can pierce the same receptacle 19222. In some cases, some of the staple legs of the staples 19030 may not pierce the container 19222 positioned thereon; The lumen is pierced to allow the pressure of the lumen gas to equilibrate with the atmospheric pressure surrounding the container 19222. Referring now to FIG. 185, a tissue thickness compensator can include, for example, a container, such as container 19222', that can extend in a direction transverse to staple line 19030. For example, the container 19222' can extend across multiple staple rows. Referring now to FIG. 186 , a tissue thickness compensator 19220 ″ can include a plurality of receptacles 19222 ″ extending in a direction perpendicular, or at least substantially perpendicular, to staple line 19030 . For example, some of the containers 19222" may be pierced by the staples 19030, while others may not be pierced by the staples 19030. For example, the containers 19222" may extend across or through a cutting path, wherein the cutting member may traverse the containers 19222" and make it crack.
任选地,如上所述,例如,组织厚度补偿件诸如组织厚度补偿件19220例如可以包括多个密封容器,诸如容器19222。还如上所述,密封容器19222的每一个可包括独立的内部气体。容器19222可具有不同的内部压力。例如,第一容器19222可包括具有第一压力的内部真空,并且第二容器19222可包括具有第二不同压力的内部真空。例如,容器19222的变形或平化量可取决于其中包含的内部气体的真空压力。例如,与具有较小真空的容器19222相比,具有较大真空的容器19222可以变形或平化更大的量。容器的腔体可被分段为两个或更多个独立的密封腔体,其中每个独立的密封腔体可包括独立的内部气体。例如,钉行中的一些钉可例如能够和布置为刺穿限定在容器中的第一腔体,同时钉行中的其他钉可能够和布置为刺穿限定在容器中的第二腔体。在这种情况下,尤其是在其中钉行中的钉从钉行的一端被顺序击发到另一端的实施例中,如上所述,腔体中的一者可在另一个腔体破裂时保持完整并且可维持其内部气体。例如,第一腔体可具有内部气体,其具有第一真空压力,并且第二腔体可具有内部气体,其具有第二不同真空压力。根据本发明,保持完整的腔体可维持其内部压力,直到容器被生物吸收,从而形成定时压力释放。Optionally, a tissue thickness compensator such as tissue thickness compensator 19220 can include a plurality of sealed containers, such as container 19222, for example, as described above. As also described above, each of the sealed containers 19222 may include an independent internal gas. The container 19222 can have different internal pressures. For example, a first container 19222 can include an internal vacuum at a first pressure, and a second container 19222 can include an internal vacuum at a second, different pressure. For example, the amount of deformation or flattening of the container 19222 may depend on the vacuum pressure of the internal gas contained therein. For example, a container 19222 with a greater vacuum may deform or flatten a greater amount than a container 19222 with a smaller vacuum. The cavity of the container may be segmented into two or more separate sealed cavities, where each separate sealed cavity may contain a separate internal gas. For example, some staples in a row of staples may, for example, be capable and arranged to pierce a first cavity defined in the container, while other staples in the row of staples may be capable and arranged to pierce a second cavity defined in the receptacle. In this case, especially in embodiments where the staples in the row are sequentially fired from one end of the row to the other, as described above, one of the cavities may remain open when the other cavity ruptures. Intact and capable of maintaining its internal gas. For example, a first cavity may have an internal gas with a first vacuum pressure, and a second cavity may have an internal gas with a second, different vacuum pressure. According to the present invention, keeping the cavity intact maintains its internal pressure until the container is bioabsorbed, thereby creating a timed pressure release.
现在参见图181和图182,组织厚度补偿件诸如组织厚度补偿件19120例如可附接到砧座19160。与上文类似,组织厚度补偿件19120可包括容器19124和定位于其中的多个弹性构件19122。还与上文类似,容器19124可限定包含内部气体的腔体,该内部气体具有小于或大于组织厚度补偿件19120周围的大气压强的压强。在容器19124内的内部气体包含真空的情况下,容器19124和定位于其中的弹性构件19122可以通过容器19124中的真空与容器19124外部的大气压强之间的压强差而变形、塌缩和/或平化。在使用中,砧座19160可以运动到闭合位置,其中砧座相对于钉仓19100定位,并且其中容器19124上的组织接合表面19121可以接合定位在组织厚度补偿件19120和钉仓19100中间的组织T。在使用中,击发构件19080可以朝远侧推进以击发钉19030,如上所述,并且同时切割组织T。组织厚度补偿件19120还可包括中间部分19126,该中间部分可与限定在砧座19160中的切割狭槽对齐,其中当击发构件19080朝远侧推进穿过组织厚度补偿件19120时,击发构件19080可以刺穿容器19124或使其破裂。另外,与上文类似,击发构件19080可以向上提升钉驱动器19040并且击发钉19030,使得钉19030可以接触砧座19160并且变形到其变形构型,如图183所示。当钉19030被击发时,钉19030可以刺穿组织T然后刺穿容器19124或使其破裂,使得定位在容器19124内的弹性构件19122可以至少部分地膨胀,如上所述。Referring now to FIGS. 181 and 182 , a tissue thickness compensator such as tissue thickness compensator 19120 , for example, can be attached to anvil 19160 . Similar to the above, the tissue thickness compensator 19120 can include a container 19124 and a plurality of elastic members 19122 positioned therein. Also similar to the above, the container 19124 can define a cavity containing an internal gas having a pressure that is less than or greater than the atmospheric pressure surrounding the tissue thickness compensator 19120 . Where the internal gas within the container 19124 contains a vacuum, the container 19124 and the resilient member 19122 positioned therein may be deformed, collapsed, and/or Flatten. In use, the anvil 19160 can be moved to a closed position wherein the anvil is positioned relative to the staple cartridge 19100 and wherein the tissue engaging surface 19121 on the receptacle 19124 can engage tissue T positioned intermediate the tissue thickness compensator 19120 and the staple cartridge 19100 . In use, the firing member 19080 can be advanced distally to fire the staples 19030, as described above, and cut the tissue T simultaneously. The tissue thickness compensator 19120 can also include an intermediate portion 19126 that can be aligned with a cutting slot defined in the anvil 19160, wherein when the firing member 19080 is advanced distally through the tissue thickness compensator 19120, the firing member 19080 The container 19124 can be pierced or ruptured. Additionally, similar to the above, the firing member 19080 can lift the staple drivers 19040 upward and fire the staples 19030 such that the staples 19030 can contact the anvil 19160 and deform to their deformed configuration, as shown in FIG. 183 . When the staples 19030 are fired, the staples 19030 can pierce the tissue T and then the receptacle 19124 or rupture such that the resilient member 19122 positioned within the receptacle 19124 can at least partially expand, as described above.
对上文进行进一步描述,组织厚度补偿件可由生物相容性材料构成。生物相容性材料(诸如泡沫)可包括增粘剂、表面活性剂、填充剂、交联剂、颜料、染料、抗氧化剂和其他稳定剂和/或它们的组合,以为材料提供所需特性。生物相容性泡沫可包括表面活性剂。表面活性剂可被施加到材料表面和/或被分散在材料内。不希望受限于任何特定理论,施加到生物相容性材料的表面活性剂可以降低接触材料的流体的表面张力。例如,表面活性剂可以降低接触材料的水的表面张力,以加速水渗入材料。水可以充当催化剂。表面活性剂可以提高材料的亲水性。Further to the above, the tissue thickness compensator may be constructed of a biocompatible material. Biocompatible materials such as foams may include tackifiers, surfactants, fillers, crosslinkers, pigments, dyes, antioxidants and other stabilizers and/or combinations thereof to provide the material with desired properties. Biocompatible foams may include surfactants. Surfactants may be applied to the surface of the material and/or dispersed within the material. Without wishing to be bound by any particular theory, a surfactant applied to a biocompatible material can lower the surface tension of fluids that contact the material. For example, surfactants can lower the surface tension of water contacting a material to speed water penetration into the material. Water can act as a catalyst. Surfactants can increase the hydrophilicity of materials.
表面活性剂可包括阴离子表面活性剂、阳离子表面活性剂和/或非离子表面活性剂。表面活性剂的示例包括但不限于聚丙烯酸、纤维素甲醚(methalose)、甲基纤维素、乙基纤维素、丙基纤维素、羟乙基纤维素、羧甲基纤维素、聚氧乙烯十六烷基醚、聚氧乙烯月桂基醚、聚氧乙烯辛基醚、聚氧乙烯辛基苯基醚、聚氧乙烯油基醚、聚氧乙烯脱水山梨糖醇单月桂酸酯、聚氧乙烯硬脂基醚、聚氧乙烯壬基苯基醚、二烷基苯氧基聚(乙烯氧基)乙醇和泊洛沙姆,以及它们的组合。表面活性剂可包括聚乙二醇和聚丙二醇的共聚物。表面活性剂可包括磷脂表面活性剂。磷脂表面活性剂可提供抗菌稳定性和/或将其他材料分散在生物相容性材料中。组织厚度补偿件可包含至少一种药物。组织厚度补偿件可包含本文所述的天然材料、非合成材料、和/或合成材料中的一者或多者。组织厚度补偿件可包括生物相容性泡沫,所述生物相容性泡沫包括明胶、胶原、透明质酸、氧化再生纤维素、聚乙醇酸、聚己内酯、聚乳酸、聚二氧杂环己酮、聚羟基链烷酸酯、聚卡普隆和它们的组合。组织厚度补偿件可包括膜,所述膜包含至少一种药物。组织厚度补偿件可包括生物降解膜,所述生物降解膜包含至少一种药物。药物可包括液体、凝胶和/或粉末。药物可包括抗癌剂,诸如顺铂、丝裂霉素和/或阿霉素。Surfactants may include anionic surfactants, cationic surfactants and/or nonionic surfactants. Examples of surfactants include, but are not limited to, polyacrylic acid, cellulose methyl ether (methalose), methylcellulose, ethylcellulose, propylcellulose, hydroxyethylcellulose, carboxymethylcellulose, polyoxyethylene Cetyl ether, polyoxyethylene lauryl ether, polyoxyethylene octyl ether, polyoxyethylene octylphenyl ether, polyoxyethylene oleyl ether, polyoxyethylene sorbitan monolaurate, polyoxyethylene Vinyl stearyl ether, polyoxyethylene nonylphenyl ether, dialkylphenoxypoly(ethyleneoxy)ethanol, and poloxamers, and combinations thereof. Surfactants may include copolymers of polyethylene glycol and polypropylene glycol. Surfactants may include phospholipid surfactants. Phospholipid surfactants can provide antimicrobial stability and/or disperse other materials in biocompatible materials. The tissue thickness compensator may contain at least one drug. The tissue thickness compensator may comprise one or more of the natural materials, non-synthetic materials, and/or synthetic materials described herein. The tissue thickness compensator may comprise biocompatible foams including gelatin, collagen, hyaluronic acid, oxidized regenerated cellulose, polyglycolic acid, polycaprolactone, polylactic acid, polydioxane Hexanone, polyhydroxyalkanoate, polycapron and combinations thereof. The tissue thickness compensator may include a membrane comprising at least one drug. The tissue thickness compensator may comprise a biodegradable film comprising at least one drug. Medications may include liquids, gels, and/or powders. Drugs may include anticancer agents such as cisplatin, mitomycin and/or doxorubicin.
组织厚度补偿件可包含生物降解材料,以在生物降解材料降解时提供至少一种药物的受控洗脱。当生物降解材料接触活化剂诸如活化液时,生物降解材料可以降解,可以分解,或丢失结构完整性。例如,活化液可包括盐水溶液或任何其他电解质溶液。生物降解材料可借助常规技术来接触活化液,所述技术包括但不限于喷涂、浸渍和/或刷涂。在使用中,例如,外科医生可将包括组织厚度补偿件(其包含至少一种药物)的端部执行器和/或钉仓浸入活化液中,所述活化液包括盐溶液,诸如氯化钠、氯化钙、和/或氯化钾。组织厚度补偿件可在组织厚度补偿件降解时释放药物。药物从组织厚度补偿件的洗脱的特征可在于快速初始洗脱率和慢速持续洗脱率。The tissue thickness compensator may comprise a biodegradable material to provide controlled elution of the at least one drug as the biodegradable material degrades. The biodegradable material can degrade, can disintegrate, or lose structural integrity when it contacts an activating agent, such as an activation solution. For example, the activation solution may include saline solution or any other electrolyte solution. The biodegradable material can be contacted with the activation solution by conventional techniques including, but not limited to, spraying, dipping, and/or brushing. In use, for example, the surgeon may immerse the end effector and/or the staple cartridge including the tissue thickness compensator (which contains at least one drug) in an activation solution comprising a saline solution such as sodium chloride , calcium chloride, and/or potassium chloride. The tissue thickness compensator releases the drug when the tissue thickness compensator degrades. Elution of drug from the tissue thickness compensator can be characterized by a fast initial elution rate and a slow sustained elution rate.
根据本发明,组织厚度补偿件例如可由可包含氧化剂的生物相容性材料组成。氧化剂可为有机过氧化物和/或无机过氧化物。氧化剂的示例可包括但不限于过氧化氢、过氧化脲、过氧化钙和过氧化镁,以及过碳酸钠。氧化剂可包括过氧基氧化剂和次卤酸盐基氧化剂,诸如过氧化氢、次氯酸、次氯酸盐、hypocodites、以及过碳酸盐。氧化剂可包括碱金属氯酸盐、次氯酸盐和过硼酸盐,诸如亚氯酸钠、次氯酸钠和过硼酸钠。氧化剂可包括钒酸盐。氧化剂可包括抗坏血酸。氧化剂可包括活性氧发生器。根据本发明,组织支架可包含生物相容性材料,所述生物相容性材料包含氧化剂。According to the invention, the tissue thickness compensator may for example consist of a biocompatible material which may contain an oxidizing agent. The oxidizing agent may be an organic peroxide and/or an inorganic peroxide. Examples of oxidizing agents may include, but are not limited to, hydrogen peroxide, carbamide peroxide, calcium and magnesium peroxide, and sodium percarbonate. Oxidizing agents may include peroxyl and hypohalite-based oxidizing agents, such as hydrogen peroxide, hypochlorous acid, hypochlorites, hypocodites, and percarbonates. Oxidizing agents may include alkali metal chlorates, hypochlorites, and perborates, such as sodium chlorite, hypochlorite, and perborate. The oxidizing agent may include vanadate. Oxidizing agents may include ascorbic acid. The oxidizing agent may include an active oxygen generator. According to the invention, the tissue scaffold may comprise a biocompatible material comprising an oxidizing agent.
生物相容性材料可包括液体、凝胶和/或粉末。例如,氧化剂可包括微粒和/或纳米颗粒。例如,氧化剂可以研磨成微粒和/或纳米颗粒。可通过将氧化剂悬浮在聚合物溶液中而使氧化剂结合到生物相容性材料中。氧化剂可在冻干工艺期间结合到生物相容性材料中。冻干之后,氧化剂可附接到生物相容性材料的细胞壁,以在接触时与组织相互作用。氧化剂不能化学键合到生物相容性材料。过碳酸盐干粉可以嵌入在生物相容性泡沫内,以通过缓慢释放氧提供长效生物效应。过碳酸盐干粉可以嵌入在非织造结构中的聚合物纤维内,以通过缓慢释放氧提供长效生物效应。生物相容性材料可包括氧化剂和药物,诸如强力霉素和抗坏血酸。Biocompatible materials may include liquids, gels and/or powders. For example, oxidizing agents may include microparticles and/or nanoparticles. For example, the oxidizing agent can be ground into microparticles and/or nanoparticles. The oxidizing agent can be incorporated into the biocompatible material by suspending the oxidizing agent in a polymer solution. Oxidizing agents can be incorporated into the biocompatible material during the lyophilization process. After lyophilization, the oxidizing agent can attach to the cell walls of the biocompatible material to interact with the tissue upon contact. Oxidizing agents cannot chemically bond to biocompatible materials. Dry percarbonate powders can be embedded within biocompatible foams to provide long-lasting biological effects through the slow release of oxygen. Dry percarbonate powders can be embedded within polymer fibers in nonwoven structures to provide long-lasting biological effects through slow release of oxygen. Biocompatible materials may include oxidizing agents and drugs such as doxycycline and ascorbic acid.
生物相容性材料可包括快速释放氧化剂和/或慢速持续释放氧化剂。氧化剂从生物相容性材料的洗脱的特征可在于快速初始洗脱率和慢速持续洗脱率。当氧化剂接触体液(诸如水)时,氧化剂可生成氧气。体液的示例可包括但不限于血液、血浆、腹膜液、脑脊髓液、尿液、淋巴液、滑液、玻璃体液、唾液、胃肠腔内容物和/或胆汁。不希望受限于任何特定理论,氧化剂可以减少细胞死亡,增强组织活力和/或维持可在切割和/或缝合过程中被破坏的组织到组织的机械强度。生物相容性材料可包括至少一个微粒和/或纳米颗粒。生物相容性材料可包括本文所述的天然材料、非合成材料和合成材料中的一者或多者。生物相容性材料可包括平均直径为约10nm至约100nm和/或约10μm至约100μm,诸如45-50nm和/或45-50μm的颗粒。生物相容性材料可包括生物相容性泡沫,所述生物相容性泡沫包括嵌入其中的至少一个微粒和/或纳米颗粒。微粒和/或纳米颗粒不能化学键合到生物相容性材料。微粒和/或纳米颗粒可以提供药物的受控释放。微粒和/或纳米颗粒可包含至少一种药物。例如,微粒和/或纳米颗粒可包含止血剂、抗微生物剂和/或氧化剂。组织厚度补偿件可包括生物相容性泡沫,所述生物相容性泡沫包含止血剂(其包括氧化再生纤维素)、抗微生物剂(其包括强力霉素和/或庆大霉素)和/或氧化剂(其包括percarbant)。例如,微粒和/或纳米颗粒可提供最多至三天的药物的受控释放。The biocompatible material may include a rapid release oxidant and/or a slow sustained release oxidant. Elution of the oxidizing agent from the biocompatible material can be characterized by a fast initial elution rate and a slow sustained elution rate. When the oxidizing agent contacts bodily fluids, such as water, the oxidizing agent can generate oxygen. Examples of bodily fluids may include, but are not limited to, blood, plasma, peritoneal fluid, cerebrospinal fluid, urine, lymph, synovial fluid, vitreous humor, saliva, gastrointestinal luminal contents, and/or bile. Without wishing to be bound by any particular theory, oxidizing agents may reduce cell death, enhance tissue viability and/or maintain tissue-to-tissue mechanical strength that may be damaged during cutting and/or stapling. The biocompatible material may comprise at least one microparticle and/or nanoparticle. Biocompatible materials may include one or more of the natural, non-synthetic, and synthetic materials described herein. The biocompatible material may comprise particles having an average diameter of about 10 nm to about 100 nm and/or about 10 μm to about 100 μm, such as 45-50 nm and/or 45-50 μm. The biocompatible material may include a biocompatible foam including at least one microparticle and/or nanoparticle embedded therein. Microparticles and/or nanoparticles cannot be chemically bonded to biocompatible materials. Microparticles and/or nanoparticles can provide controlled release of drugs. Microparticles and/or nanoparticles may contain at least one drug. For example, microparticles and/or nanoparticles may contain hemostatic agents, antimicrobial agents, and/or oxidizing agents. The tissue thickness compensator may comprise a biocompatible foam comprising a hemostatic agent including oxidized regenerated cellulose, an antimicrobial agent including doxycycline and/or gentamicin, and/or or oxidizing agents (which include percarbant). For example, microparticles and/or nanoparticles can provide controlled release of drug for up to three days.
微粒和/或纳米颗粒可在制造过程中嵌入在生物相容性材料中。例如,生物相容性聚合物(诸如PGA/PCL)可以接触溶剂(诸如二氧杂环己烷)以形成混合物。可以研磨生物相容性聚合物以形成颗粒。具有或不具有ORC颗粒的干颗粒可与混合物接触以形成混悬剂。该混悬剂可被冻干以形成生物相容性泡沫,该生物相容性泡沫包括具有嵌入其中的干颗粒和/或ORC颗粒的PGA/PCL。Microparticles and/or nanoparticles can be embedded in biocompatible materials during the manufacturing process. For example, a biocompatible polymer such as PGA/PCL can be contacted with a solvent such as dioxane to form a mixture. Biocompatible polymers can be milled to form particles. Dry particles, with or without ORC particles, can be contacted with the mixture to form a suspension. The suspension can be lyophilized to form a biocompatible foam comprising PGA/PCL with dry particles and/or ORC particles embedded therein.
例如,本文所公开的组织厚度补偿件或层可由可吸收的聚合物构成。例如,组织厚度补偿件可由以下物质构成:泡沫、膜、纤维织造材料、纤维非织造PGA、PGA/PCL(聚(乙醇酸-共-己内酯))、PLA/PCL(聚(乳酸-共-聚己内酯))、PLLA/PCL、PGA/TMC(聚(乙醇酸-共-三亚甲基碳酸酯))、PDS、PEPBO或其他可吸收的聚氨酯、聚酯、聚碳酸酯、聚原酸酯、聚酸酐、聚酯酰胺、和/或聚含氧酸酯。根据本发明,组织厚度补偿件可由例如PGA/PLA(聚(乙醇酸-共-乳酸))和/或PDS/PLA(聚(对二氧杂环己酮-共-乳酸))构成。根据本发明,组织厚度补偿件可由例如有机材料构成。例如,组织厚度补偿件可由羧甲基纤维素、藻酸钠、交联透明质酸、和/或氧化再生纤维素构成。根据本发明,组织厚度补偿件可包括范围为3-7肖氏A(30-50肖氏OO)的硬度计,其中最大刚度为例如15肖氏A(65肖氏OO)。组织厚度补偿件可例如在3磅力负载下经受40%的压缩,在6磅力负载下经受60%的压缩,和/或在20磅力负载下经受80%的压缩。一种或多种气体(诸如空气、氮气、二氧化碳和/或氧气)例如可鼓入和/或包含在组织厚度补偿件内。组织厚度补偿件可在其中包含构成组织厚度补偿件的小珠,所述小珠包括介于约50%和约75%之间的材料刚度。For example, the tissue thickness compensators or layers disclosed herein can be composed of absorbable polymers. For example, the tissue thickness compensator can be constructed of the following: foam, film, fibrous woven material, fibrous nonwoven PGA, PGA/PCL (poly(glycolic acid-co-caprolactone)), PLA/PCL (poly(lactic acid-co-caprolactone) -polycaprolactone)), PLLA/PCL, PGA/TMC (poly(glycolic acid-co-trimethylene carbonate)), PDS, PEPBO or other resorbable polyurethane, polyester, polycarbonate, polyarethane esters, polyanhydrides, polyesteramides, and/or polyoxyesters. According to the invention, the tissue thickness compensator can consist of, for example, PGA/PLA (poly(glycolic acid-co-lactic acid)) and/or PDS/PLA (poly(p-dioxanone-co-lactic acid)). According to the invention, the tissue thickness compensator can consist, for example, of an organic material. For example, the tissue thickness compensator can be composed of carboxymethyl cellulose, sodium alginate, cross-linked hyaluronic acid, and/or oxidized regenerated cellulose. According to the present invention, the tissue thickness compensator may comprise a durometer in the range of 3-7 Shore A (30-50 Shore OO), with a maximum stiffness of eg 15 Shore A (65 Shore OO). The tissue thickness compensator may, for example, experience 40% compression under a 3 lbf load, 60% compression under a 6 lbf load, and/or 80% compression under a 20 lbf load. One or more gases, such as air, nitrogen, carbon dioxide, and/or oxygen, for example, may be bubbled into and/or contained within the tissue thickness compensator. The tissue thickness compensator may contain therein beads comprising between about 50% and about 75% of the material stiffness comprising the tissue thickness compensator.
根据本发明,组织厚度补偿件可包含例如透明质酸、营养成分、血纤维蛋白、凝血酶、富含血小板的血浆、柳氮磺胺吡啶(–5ASA+磺胺吡啶重氮键)-前体药物–结肠细菌(偶氮还原酶)、氨水杨酸(具有用于延迟释放的不同前体药物配置的5ASA)、(5ASA+尤特奇-S包衣–pH>7(包衣溶解))、(5ASA+乙基纤维素包衣–基于时间/pH的缓慢释放)、(5ASA+尤特奇-L包衣–pH>6)、奥沙拉嗪(5ASA+5ASA–结肠细菌(偶氮还原酶))、巴柳氮(5ASA+4氨基苯甲酰-B-丙氨酸)-结肠细菌(偶氮还原酶))、造粒美沙拉嗪、Lialda(美沙拉嗪的延缓和缓释配方)、HMPL-004(本草混合物,HMPL-004(可抑制TNF-α、白介素-1β和核-κB的活化的草本植物混合物)、CCX282-B(干扰T淋巴细胞进入肠粘膜的口服趋化因子受体拮抗剂)、利福昔明(非可吸收性广谱抗生素)、英夫利昔单抗、小鼠嵌合抗体(直接针对TNF-α的单克隆抗体,其被批准用于减轻对常规治疗反应不足的患有中度/重度管腔和瘘管型克罗恩病的成人/儿童患者的体征/症状和维持临床缓解)、阿达木单抗、人总IgG1(抗TNF-α的单克隆抗体,其被批准用于减轻克罗恩病的体征/症状,以及用于诱导和维持对常规治疗反应不足,或成为不耐受英夫利昔单抗的患有中度/重度活动性克罗恩病的成人患者的临床缓解)、赛妥珠单抗、人源化抗TNF FAB’(连接到聚乙二醇的单克隆抗体片段,其被批准用于减轻克罗恩病的体征/症状,以及用于诱导和维持对常规治疗反应不足的患有中度/重度疾病的成年患者的反应)、那他珠单抗、第一非TNF-α抑制剂(批准用于克罗恩病的生物化合物)、人源化单克隆IgG4抗体(直接针对α-4整联蛋白,获得FDA批准用于诱导和维持证实有炎症且对常规克罗恩治疗和TNF-α抑制剂反应不足或无法耐受常规克罗恩治疗和TNF-α抑制剂的患有中度/重度疾病的患者的临床反应和缓解)、可能给定有英夫利昔单抗的伴随免疫调节剂、硫唑嘌呤6-巯嘌呤(嘌呤合成抑制剂–前体药物)、甲氨蝶呤(结合二氢叶酸还原酶(DHFR)酶,其参与四氢叶酸的合成,抑制所有嘌呤的合成)、别嘌呤醇和硫嘌呤治疗、PPI、用于抑酸以保护愈合线的H2、艰难梭菌(C-Diff)–甲硝哒唑、万古霉素(粪便易位处理;益生菌;腔内正常菌群复育)、和/或利福昔明(细菌过度生长处理(尤其是肝性脑病);在胃肠道中不吸收而对腔内细菌起作用)。According to the present invention, the tissue thickness compensator may comprise, for example, hyaluronic acid, nutrients, fibrin, thrombin, platelet-rich plasma, sulfasalazine ( – 5ASA + sulfapyridine diazo bond)-prodrugs – colonic bacteria (azoreductase), aminosalicylic acid (5ASA with different prodrug configurations for delayed release), (5ASA+ Eudragit-S coating – pH>7 (coating dissolved)), (5ASA+Ethylcellulose coating – slow release based on time/pH), (5ASA+ Eudragit-L Coating – pH>6), Osalazine (5ASA+5ASA – Colonic Bacteria (Azoreductase)), Balsalazide (5ASA+4-aminobenzoyl-B-alanine )-colon bacteria (azoreductase)), granulated mesalamine, Lialda (delayed and sustained-release formulation of mesalamine), HMPL-004 (herbal mixture, HMPL-004 (can inhibit TNF-α, interleukin- 1β and nuclear-κB activated herbal mixture), CCX282-B (an oral chemokine receptor antagonist that interferes with T lymphocyte entry into the intestinal mucosa), rifaximin (a non-absorbable broad-spectrum antibiotic), Inf Liximab, a mouse chimeric antibody (a monoclonal antibody directed against TNF-alpha, approved for the relief of severe luminal and fistula Crohn's disease in adults with /signs/symptoms and maintenance of clinical remission in pediatric patients), adalimumab, human total IgG1 (monoclonal antibody against TNF-α, which is approved for the reduction of signs/symptoms of Crohn's disease, and for induction and maintenance of clinical remission in adult patients with moderately/severely active Crohn's disease who do not respond to conventional therapy or become intolerant to infliximab), certolizumab, humanized anti-TNF FAB' (monoclonal antibody fragment linked to polyethylene glycol, which is approved for the relief of signs/symptoms of Crohn's disease, and for the induction and maintenance of response in adult patients), natalizumab, first non-TNF-α inhibitor (biologic compound approved for Crohn’s disease), humanized monoclonal IgG4 antibody (directly targeting α-4 integrin, FDA-approved for the induction and maintenance of moderate/severe disease in patients with proven inflammation who have had an inadequate response to or are intolerant to conventional Crohn's therapy and TNF-α inhibitors patient’s clinical response and remission), may be given concomitant immunomodulators with infliximab, azathioprine 6-mercaptopurine (purine synthesis inhibitor – prodrug), methotrexate (conjugated dihydrofolate Reductase (DHFR) enzyme, which is involved in the synthesis of tetrahydrofolate, inhibits the synthesis of all purines), allopurinol and thiopurine therapy, PPI, H2 for acid suppression to protect the healing line, Clostridium difficile (C-Diff) – Metronidazole, vancomycin (management of fecal translocation; probiotics; reinstatement of normal luminal flora), and/or rifaximin (management of bacterial overgrowth (especially hepatic encephalopathy); It is not absorbed in the tract but acts on the bacteria in the cavity).
如本文所述,例如,组织厚度补偿件可以补偿被捕获在从钉仓中射出的和/或包含在钉线内的钉内的组织的厚度的变化。换句话讲,钉线内的某些钉可以捕获组织的较厚部分,而钉线内的其他钉可以捕获组织的较薄部分。在这种情况下,组织厚度补偿件可在钉内呈现不同高度或厚度,并将压缩力施加到被捕获在钉内的组织而不论被捕获组织是厚还是薄。根据本发明,组织厚度补偿件可补偿组织硬度的变化。例如,钉线内的某些钉可以捕获组织的高度可压缩部分,而钉线内的其他钉可以捕获组织的可压缩性更小部分。在这种情况下,例如,组织厚度补偿件能够在钉(其已捕获具有较低可压缩性的组织)内呈现较小高度或较高硬度,并且相应地,能够在钉(其已捕获具有较高可压缩性的组织)内呈现较大高度或较低硬度。在任何情况下,例如,无论组织厚度补偿件是否补偿组织厚度的变化和/或组织硬度的变化,其均可被称为“组织补偿件”和/或“补偿件”。As described herein, for example, a tissue thickness compensator can compensate for variations in the thickness of tissue captured within staples fired from a staple cartridge and/or contained within a staple line. In other words, some staples within the staple line can capture thicker portions of tissue, while other staples within the staple line can capture thinner portions of tissue. In this case, the tissue thickness compensator can assume different heights or thicknesses within the staple and apply a compressive force to tissue captured within the staple regardless of whether the captured tissue is thick or thin. According to the present invention, the tissue thickness compensator compensates for changes in tissue stiffness. For example, some staples within the staple line can capture highly compressible portions of tissue, while other staples within the staple line can capture less compressible portions of tissue. In this case, for example, the tissue thickness compensator can exhibit a smaller height or higher stiffness within the staple (which has captured tissue with less compressibility), and correspondingly, can Tissues with higher compressibility) exhibit greater height or less stiffness. In any event, for example, a tissue thickness compensator may be referred to as a "tissue compensator" and/or a "compensator" regardless of whether it compensates for changes in tissue thickness and/or changes in tissue stiffness.
可将本发明所公开的装置设计为单次使用后即进行处理,或者可将它们设计为可多次使用。然而,在任一种情况下,所述装置均可被修复,以在至少一次使用后再次使用。修复可包括如下步骤的任意组合:拆卸所述装置、然后清洗或替换特定部件以及随后重新装配。特别是,所述装置可被拆卸,而且可以任意组合选择性地替换或取出所述装置的任意数目的特定部件或部分。清洗和/或替换特定部件之后,所述装置可以在修复设施处、或者在即将进行外科手术前由手术团队重新装配以便随后使用。本领域的技术人员将了解到,装置的修复可利用多种用于拆卸、清洗/替换和重新装配的技术。这些技术的使用以及所得的被修复装置均在本发明的范围内。The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning may include any combination of disassembly of the device, followed by cleaning or replacement of certain parts, and subsequent reassembly. In particular, the device may be disassembled and any number of specific components or parts of the device may be selectively replaced or removed in any combination. After cleaning and/or replacement of certain components, the device may be reassembled for subsequent use at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of these techniques and the resulting repaired devices are within the scope of the present invention.
优选的是,本文所述的本发明将在手术前得以处理。首先,获取新的或用过的器械,并在必要时对器械进行清洁。然后对器械进行消毒。在一种消毒技术中,将所述器械置于闭合并密封的容器中,例如塑料或TYVEK袋中。然后将容器和器械置于能够穿透所述容器的辐射场内,例如γ辐射、x-射线或高能电子。辐射将器械上和容器中的细菌杀死。然后将消毒后的器械储存在无菌容器中。该密封容器将器械保持无菌,直到在医疗设施中打开该容器为止。Preferably, the invention described herein will be treated prior to surgery. First, obtain new or used instruments and, if necessary, clean them. The instruments are then sterilized. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument are then placed in a field of radiation capable of penetrating the container, such as gamma radiation, x-rays, or high energy electrons. Irradiation kills bacteria on instruments and in containers. The sterilized instruments are then stored in sterile containers. The sealed container keeps the instrument sterile until the container is opened in the medical facility.
以引用方式全文或部分地并入本文的任何专利、专利公开或其他公开材料均仅在所并入的材料不与本发明所述的现有定义、陈述或其他公开材料相冲突的范围内并入本文。由此,在必要的程度下,本文所明确阐述的公开内容将取代以引用方式并入本文的任何相冲突的材料。任何据称为以引用方式并入本文但与本文所述的现有定义、陈述或其他公开材料相冲突的任何材料或其部分将仅在所并入的材料和现有的公开材料之间不产生冲突的程度下并入本文。Any patent, patent publication, or other published material incorporated herein by reference, in whole or in part, is only to the extent that the incorporated material does not conflict with an existing definition, statement, or other disclosed material set forth herein. into this article. Accordingly, to the extent necessary, the disclosure as expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is purportedly incorporated herein by reference but that conflicts with existing definitions, statements, or other disclosed material set forth herein will be solely between the incorporated material and the existing disclosed material. Incorporated herein to the extent conflict arises.
尽管已经将本发明作为示例性设计进行了描述,但还可以在本公开的精神和范围内对本发明进行另外的修改。因此本专利申请旨在涵盖采用本发明一般原理的任何变型、用途或适应型式。此外,本专利申请旨在涵盖本发明所属领域中出自已知或惯有实践范围内的背离本公开的型式。While this invention has been described as an exemplary design, further modifications can be made to the present invention within the spirit and scope of this disclosure. This patent application is therefore intended to cover any variations, uses or adaptations of the general principles of the invention. Furthermore, this patent application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US13/433,141US10123798B2 (en) | 2010-09-30 | 2012-03-28 | Tissue thickness compensator comprising controlled release and expansion |
| US13/433,141 | 2012-03-28 | ||
| PCT/US2013/034004WO2013148767A1 (en) | 2012-03-28 | 2013-03-27 | Tissue thickness compensator comprising controlled release and expansion |
| Publication Number | Publication Date |
|---|---|
| CN104349800A CN104349800A (en) | 2015-02-11 |
| CN104349800Btrue CN104349800B (en) | 2017-11-10 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201380028028.XAActiveCN104349800B (en) | 2012-03-28 | 2013-03-27 | Tissue thickness compensation part including controlled release and expansion |
| Country | Link |
|---|---|
| JP (1) | JP6320989B2 (en) |
| CN (1) | CN104349800B (en) |
| MX (1) | MX373516B (en) |
| RU (1) | RU2637167C2 (en) |
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| JP6320989B2 (en) | 2018-05-09 |
| CN104349800A (en) | 2015-02-11 |
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| RU2637167C2 (en) | 2017-11-30 |
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| SE01 | Entry into force of request for substantive examination | ||
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