背景技术Background technique
本发明涉及外科器械，并且在各种布置中，涉及被设计成缝合和切割组织的外科缝合和切割器械及其钉仓。The present invention relates to surgical instruments and, in various arrangements, to surgical stapling and cutting instruments and cartridges thereof designed to staple and cut tissue.
附图说明Description of drawings
通过结合附图来参考本发明实施方案的以下说明，本发明的特征和优点以及实现这些特征和优点的方式将会变得更加明显，并且可更好地理解发明本身，其中：The features and advantages of the present invention, and the manner of achieving them, will become more apparent, and the invention itself can be better understood, by reference to the following description of embodiments of the invention, taken in conjunction with the accompanying drawings, in which:
图1为具有柄部部分的外科缝合和切断器械的左前透视图；Figure 1 is a left front perspective view of a surgical stapling and cutting instrument having a handle portion;
图2为图1的外科缝合和切断器械的两件式刀和击发杆(“E形梁”)的透视图；Figure 2 is a perspective view of the two-piece knife and firing bar ("E-beam") of the surgical stapling and severing instrument of Figure 1;
图3为钉施用组件的钉仓的楔形滑动件的透视图；3 is a perspective view of a wedge sled of a staple cartridge of the staple applying assembly;
图4为钉仓和处于闭合位置的砧座的纵向剖面图，该钉仓包括刚性支撑部分和可压缩组织厚度补偿件，示出了钉在第一序列期间从未击发位置运动到击发位置；4 is a longitudinal cross-sectional view of a staple cartridge, including a rigid support portion and a compressible tissue thickness compensator, and an anvil in a closed position, showing movement of the staples from an unfired position to a fired position during a first sequence;
图5为图4的砧座和钉仓的另一个剖面图，示出了完成击发序列后处于打开位置的砧座；5 is another cross-sectional view of the anvil and staple cartridge of FIG. 4, showing the anvil in an open position after completion of the firing sequence;
图6为组织厚度补偿件和钉仓组件的分解透视图；6 is an exploded perspective view of a tissue thickness compensator and a staple cartridge assembly;
图7为图6的钉仓组件的局部剖视图，示出定位在钉仓体的钉腔中且部分嵌入组织厚度补偿件中的未击发的钉；7 is a partial cross-sectional view of the staple cartridge assembly of FIG. 6, showing unfired staples positioned in the staple cavities of the staple cartridge body and partially embedded in the tissue thickness compensator;
图8为图6的钉仓组件的局部剖视图，示出从钉仓体的钉腔射出且抵靠砧座成形的击发的钉，并且进一步示出组织厚度补偿件和捕获在所成形的钉的钉截留区域内的组织；8 is a partial cross-sectional view of the staple cartridge assembly of FIG. 6, showing the fired staples ejected from the staple cavities of the staple cartridge body and formed against the anvil, and further illustrating the tissue thickness compensator and captured in the formed staples Tissue within the staple entrapment zone;
图9为外科紧固器械的端部执行器的局部透视图，其中一些部分移除而示出，并且其他部分以横截面示出；此外，端部执行器的切割构件被示为处于部分推进位置；Figure 9 is a partial perspective view of the end effector of the surgical fastening instrument, with some parts shown removed and other parts shown in cross-section; furthermore, the cutting member of the end effector is shown in partial advancement Location;
图10为图9的端部执行器的局部剖面端视图，其中示出患者组织捕获在端部执行器的砧座和组织厚度补偿件之间；此外，可移除地储存在端部执行器的仓体内的钉被示为处于未击发位置并且端部执行器的切割构件被示为处于靠近组织厚度补偿件的未推进位置；10 is a partial cross-sectional end view of the end effector of FIG. 9 showing patient tissue captured between an anvil of the end effector and a tissue thickness compensator; furthermore, removably stored in the end effector The staples within the cartridge are shown in an unfired position and the cutting member of the end effector is shown in an unadvanced position proximate to the tissue thickness compensator;
图11为图9的端部执行器的局部剖面端视图，其中示出钉处于击发位置并且切割构件处于部分推进位置，其中患者组织已被至少部分地横切；11 is a partial cross-sectional end view of the end effector of FIG. 9, showing the staples in a fired position and the cutting member in a partially advanced position, wherein patient tissue has been at least partially transected;
图12为图9的端部执行器的局部剖面端视图，其中示出钉处于击发位置并且切割构件处于推进位置，其中组织厚度补偿件的至少一部分已被切割构件横切；12 is a partial cross-sectional end view of the end effector of FIG. 9, showing the staples in the fired position and the cutting member in the advanced position, wherein at least a portion of the tissue thickness compensator has been transected by the cutting member;
图13为包括组织厚度补偿件的紧固件仓的透视图；13 is a perspective view of a fastener cartridge including a tissue thickness compensator;
图14为图13的组织厚度补偿件的剖视图，示出相对于组织厚度补偿件的近侧端部定位的切割构件；14 is a cross-sectional view of the tissue thickness compensator of FIG. 13 showing the cutting member positioned relative to the proximal end of the tissue thickness compensator;
图15为组织厚度补偿件组件的分解图；Figure 15 is an exploded view of the tissue thickness compensator assembly;
图16为组织厚度补偿件组件层的透视图；16 is a perspective view of the layers of a tissue thickness compensator assembly;
图17为图15的组织厚度补偿件组件的剖视图；17 is a cross-sectional view of the tissue thickness compensator assembly of FIG. 15;
图18为组装的组织厚度补偿件组件以及用于组装其的模具的剖面透视图；18 is a cutaway perspective view of the assembled tissue thickness compensator assembly and the mold used to assemble it;
图19为图18的组装的组织厚度补偿件组件的透视图；19 is a perspective view of the assembled tissue thickness compensator assembly of FIG. 18;
图20为组织厚度补偿件组件以及用于组装其的模具的透视图；20 is a perspective view of a tissue thickness compensator assembly and a mold for assembling it;
图21为组织厚度补偿件组件以及用于组装其的模具的透视图；21 is a perspective view of a tissue thickness compensator assembly and a mold for assembling it;
图22为图21的组织厚度补偿件组件以及图21的用于组装其的模具的剖面透视图；22 is a cutaway perspective view of the tissue thickness compensator assembly of FIG. 21 and the mold of FIG. 21 for assembling it;
图23为包括组织厚度补偿件的端部执行器的透视图；23 is a perspective view of an end effector including a tissue thickness compensator;
图24为图23的端部执行器和组织厚度补偿件以及修改组织厚度补偿件的修改构件的透视图；24 is a perspective view of the end effector and tissue thickness compensator of FIG. 23 and modification components to modify the tissue thickness compensator;
图25为图23的包括图24的修改的组织厚度补偿件的端部执行器的透视图；25 is a perspective view of the end effector of FIG. 23 including the modified tissue thickness compensator of FIG. 24;
图26为组织厚度补偿件的剖面透视图；26 is a cutaway perspective view of a tissue thickness compensator;
图27为用于修改图26的组织厚度补偿件的模具的剖面透视图；27 is a cutaway perspective view of a mold for modifying the tissue thickness compensator of FIG. 26;
图28为图26的在由图27的模具修改之后的组织厚度补偿件的剖面透视图；28 is a cutaway perspective view of the tissue thickness compensator of FIG. 26 after modification by the mold of FIG. 27;
图29为组织厚度补偿件的剖面透视图；29 is a cutaway perspective view of a tissue thickness compensator;
图30为用于修改图29的组织厚度补偿件的模具的剖面透视图；30 is a cutaway perspective view of a mold for modifying the tissue thickness compensator of FIG. 29;
图31为图29的在由图30的模具修改之后的组织厚度补偿件的剖面透视图；31 is a cutaway perspective view of the tissue thickness compensator of FIG. 29 after modification from the mold of FIG. 30;
图32为组织厚度补偿件的剖面透视图；Figure 32 is a cutaway perspective view of a tissue thickness compensator;
图33为用于修改图32的组织厚度补偿件的模具的剖面透视图；33 is a cutaway perspective view of a mold for modifying the tissue thickness compensator of FIG. 32;
图34为图32的在由图33的模具修改之后的组织厚度补偿件的剖面透视图；34 is a cutaway perspective view of the tissue thickness compensator of FIG. 32 after modification by the mold of FIG. 33;
图35为包括第一高度的组织厚度补偿件的剖面透视图；35 is a cutaway perspective view of a tissue thickness compensator comprising a first height;
图36为图35的在修改以将第一高度改变为第二高度的组织厚度补偿件的剖面透视图；36 is a cutaway perspective view of the tissue thickness compensator of FIG. 35 modified to change the first height to a second height;
图37为用于修改图35的组织厚度补偿件的模具的剖视图；37 is a cross-sectional view of a mold for modifying the tissue thickness compensator of FIG. 35;
图38为组织厚度补偿件的剖面透视图；38 is a cutaway perspective view of a tissue thickness compensator;
图39为图38的在修改之后的组织厚度补偿件的剖面透视图；39 is a cutaway perspective view of the tissue thickness compensator of FIG. 38 after modification;
图40为示出压缩力对组织厚度补偿件的弹性比率的影响的曲线图；40 is a graph showing the effect of compressive force on the elasticity ratio of a tissue thickness compensator;
图41为组织厚度补偿件的剖面透视图；Figure 41 is a cutaway perspective view of a tissue thickness compensator;
图42为用于修改图41的组织厚度补偿件的空间创建器的剖面透视图；42 is a cutaway perspective view of a space creator for modifying the tissue thickness compensator of FIG. 41;
图43为图41的在由图42的空间创建器修改之后的组织厚度补偿件的剖面透视图；43 is a cutaway perspective view of the tissue thickness compensator of FIG. 41 after modification by the space creator of FIG. 42;
图44为根据至少一个实施方案的与包括击发构件的外科器械一起使用的紧固件仓的局部剖视正视图，其中部分移除而示出；44 is an elevational view, partially cut away, of a fastener cartridge for use with a surgical instrument including a firing member, shown with portions removed, according to at least one embodiment;
图45为局部剖视正视图，示出正从紧固件仓移除的图44的紧固件仓的组织厚度补偿件和示为处于锁定状态的图44的击发构件；45 is a partial cut-away front view showing the tissue thickness compensator of the fastener cartridge of FIG. 44 being removed from the fastener cartridge and the firing member of FIG. 44 shown in a locked state;
图46为图45的组织厚度补偿件的局部透视图；46 is a partial perspective view of the tissue thickness compensator of FIG. 45;
图47为根据至少一个实施方案的组织厚度补偿件的局部透视图；Figure 47 is a partial perspective view of a tissue thickness compensator according to at least one embodiment;
图48为包括具有图47的组织厚度补偿件的紧固件仓、滑动件以及由滑动件支撑的击发构件的外科器械的端部执行器的局部剖视正视图，其中部分移除而示出；48 is a partial cut-away front view of an end effector of a surgical instrument including a fastener cartridge having the tissue thickness compensator of FIG. 47, a sled, and a firing member supported by the sled, shown partially removed ;
图49为图48的端部执行器的局部剖视正视图，示出处于部分击发位置的击发构件；49 is a partial cutaway front view of the end effector of FIG. 48, showing the firing member in a partially fired position;
图50为图48的端部执行器的局部剖视正视图，示出从紧固件仓移除的组织厚度补偿件和处于锁定状态中的击发构件；50 is a partial cutaway front view of the end effector of FIG. 48 showing the tissue thickness compensator removed from the fastener cartridge and the firing member in a locked state;
图51为根据至少一个实施方案的紧固件仓的局部透视图，其中部分移除而示出；51 is a partial perspective view, with parts removed, of a fastener cartridge according to at least one embodiment;
图52为图51的紧固件仓的滑动件的透视图；Figure 52 is a perspective view of the slider of the fastener cartridge of Figure 51;
图53为图51的紧固件仓的局部透视图；Figure 53 is a partial perspective view of the fastener cartridge of Figure 51;
图54为根据至少一个实施方案的滑动件的正视图；Figure 54 is a front view of a slider according to at least one embodiment;
图55为根据至少一个实施方案的被示为处于未锁定构型的滑动件的透视图；Figure 55 is a perspective view of the slider shown in an unlocked configuration, according to at least one embodiment;
图56为图55的被示为处于锁定构型的滑动件的透视图；Figure 56 is a perspective view of the slider of Figure 55 shown in a locked configuration;
图57为图55的定位在紧固件仓内的滑动件的局部剖视正视图，示出处于其未锁定构型的滑动件，由滑动件支撑的击发构件，以及与滑动件接合的紧固件仓的组织厚度补偿件；57 is a partial cut-away front view of the slide of FIG. 55 positioned within the fastener cartridge, showing the slide in its unlocked configuration, the firing member supported by the slide, and the fastener engaged with the slide. Tissue thickness compensator for firmware compartment;
图58为图57的正从图57的紧固件仓移除的组织厚度补偿件的局部剖视正视图，该紧固件仓将图55的滑动件置于其锁定构型并且将图57的击发构件置于锁定状态；58 is a partial cutaway elevational view of the tissue thickness compensator of FIG. 57 being removed from the fastener cartridge of FIG. 57 with the slider of FIG. 55 in its locked configuration and the fastener cartridge of FIG. 57 The firing member is placed in a locked state;
图59为根据至少一个实施方案的定位在紧固件仓的近侧端部处的滑动件的局部剖视正视图，其中部分移除而示出；59 is a partial cutaway elevational view, partially removed, of a slider positioned at the proximal end of the fastener cartridge according to at least one embodiment;
图60为图59的被示为处于紧固件仓的远侧端部处的滑动件的局部剖视正视图；FIG. 60 is a partial cut-away front view of the slider of FIG. 59 shown at the distal end of the fastener cartridge;
图61是根据至少一个实施方案的滑动件的透视图；Figure 61 is a perspective view of a slider according to at least one embodiment;
图62为示出根据至少一个实施方案的包括多个倒钩的钉的图示，其中钉被示为处于未成形构型和变形构型中；Figure 62 is a diagram illustrating a staple comprising a plurality of barbs, wherein the staple is shown in an unformed configuration and a deformed configuration, according to at least one embodiment;
图63为根据至少一个实施方案的包括多个倒钩的钉的正视图，其中钉定位在处于未击发位置的钉腔内；63 is an elevational view of a staple comprising a plurality of barbs, wherein the staple is positioned within the staple cavity in an unfired position, according to at least one embodiment;
图64为根据至少一个实施方案的包括多个倒钩的钉的正视图；64 is an elevational view of a staple comprising a plurality of barbs, according to at least one embodiment;
图65为根据至少一个实施方案的包括多个倒钩的钉的正视图；65 is an elevational view of a staple comprising a plurality of barbs, according to at least one embodiment;
图66为根据至少一个实施方案的包括多个倒钩的钉的正视图；66 is an elevational view of a staple comprising a plurality of barbs, according to at least one embodiment;
图67为根据至少一个实施方案的包括多个倒钩的钉的正视图；67 is an elevational view of a staple comprising a plurality of barbs, according to at least one embodiment;
图68为根据至少一个实施方案的包括多个倒钩的钉的正视图，其中钉定位在处于未击发位置的钉腔内；68 is an elevational view of a staple comprising a plurality of barbs, wherein the staple is positioned within the staple cavity in an unfired position, according to at least one embodiment;
图69为图68的钉和钉腔的平面图；Figure 69 is a plan view of the staple and staple cavity of Figure 68;
图70为根据至少一个实施方案的带倒钩的钉腿的局部透视图；Figure 70 is a partial perspective view of a barbed staple leg according to at least one embodiment;
图71为图68的钉的带倒钩的钉腿的局部透视图；Figure 71 is a partial perspective view of a barbed staple leg of the staple of Figure 68;
图71A为图71的带倒钩的钉腿的剖视平面图；Figure 71A is a cutaway plan view of the barbed staple leg of Figure 71;
图72为根据至少一个实施方案的带倒钩的钉腿的局部透视图；并且72 is a partial perspective view of a barbed staple leg according to at least one embodiment; and
图73为根据至少一个实施方案的带倒钩的钉腿的局部透视图。73 is a partial perspective view of a barbed staple leg according to at least one embodiment.
具体实施方式detailed description
本申请的申请人还拥有以下鉴定的美国专利申请，这些美国专利申请各自以引用方式各自整体并入本文：The applicant of the present application also owns the following identified U.S. patent applications, each of which is incorporated herein by reference in its entirety:
名称为“SURGICAL INSTRUMENTS WITH RECONFIGURABLE SHAFT SEGMENTS”的美国专利申请序列号12/894,311(现为美国专利公布2012/0080496)；US Patent Application Serial No. 12/894,311 entitled "SURGICAL INSTRUMENTS WITH RECONFIGURABLE SHAFT SEGMENTS" (now US Patent Publication 2012/0080496);
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(现为美国专利公布2012/0080482)；U.S. Patent Application Serial No. 12/894,340 (now U.S. Patent Publication 2012/0080482), 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(现为美国专利公布2012/0080499)；U.S. Patent Application Serial No. 12/894,327, entitled "JAW CLOSURE ARRANGEMENTS FOR SURGICAL INSTRUMENTS" (now U.S. Patent Publication 2012/0080499);
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(现为美国专利公布2012/0080502)；U.S. Patent Application Serial No. 12/894,351, entitled "SURGICAL CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE ANDDISTINCT FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS" (now U.S. Patent Publication 2012/0080502);
名称为“IMPLANTABLE FASTENER CARTRIDGE HAVING A NON-UNIFORMARRANGEMENT”的美国专利申请序列号12/894,338(现为美国专利公布2012/0080481)；US Patent Application Serial No. 12/894,338, entitled "IMPLANTABLE FASTENER CARTRIDGE HAVING A NON-UNIFOR MARRANGEMENT" (now US Patent Publication 2012/0080481);
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISING A SUPPORT RETAINER”的美国专利申请序列号12/894,369(现为美国专利公布2012/0080344)；U.S. Patent Application Serial No. 12/894,369, entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING A SUPPORT RETAINER" (now U.S. Patent Publication 2012/0080344);
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS”的美国专利申请序列号12/894,312(现为美国专利公布2012/0080479)；US Patent Application Serial No. 12/894,312, entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS" (now US Patent Publication 2012/0080479);
名称为“SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE”的美国专利申请序列号12/894,377(现为美国专利8,393,514)；US Patent Application Serial No. 12/894,377 (now US Patent 8,393,514), entitled "SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE";
名称为“SURGICAL STAPLING INSTRUMENT WITH COMPACT ARTICULATION CONTROLARRANGEMENT”的美国专利申请序列号12/894,339(现为美国专利公布2012/0080500)；US Patent Application Serial No. 12/894,339 (now US Patent Publication 2012/0080500) 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(现为美国专利公布2012/0080484)；US Patent Application Serial No. 12/894,360 (now US Patent Publication 2012/0080484) 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(现为美国专利公布2012/0080501)；US Patent Application Serial No. 12/894,322 (now US Patent Publication 2012/0080501), entitled "SURGICAL STAPLING INSTRUMENT WITH INTERCHANGEABLE STAPLECARTRIDGE ARRANGEMENTS";
名称为“SURGICAL STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES”的美国专利申请序列号12/894,350(现为美国专利公布2012/0080478)；US Patent Application Serial No. 12/894,350 (now US Patent Publication 2012/0080478), entitled "SURGICAL STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES";
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISING BIOABSORBABLELAYERS”的美国专利申请序列号12/894,383(现为美国专利公布2012/0080345)；US Patent Application Serial No. 12/894,383 (now US Patent Publication 2012/0080345) 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(现为美国专利公布2012/0080335)；US Patent Application Serial No. 12/894,389 (now US Patent Publication 2012/0080335), entitled "COMPRESSIBLE FASTENER CARTRIDGE";
名称为“FASTENERS SUPPORTED BY A FASTENER CARTRIDGE SUPPORT”的美国专利申请序列号12/894,345(现为美国专利公布2012/0080483)；U.S. Patent Application Serial No. 12/894,345, entitled "FASTENERS SUPPORTED BY A FASTENER CARTRIDGE SUPPORT" (now U.S. Patent Publication 2012/0080483);
名称为“COLLAPSIBLE FASTENER CARTRIDGE”的美国专利申请序列号12/894,306(现为美国专利公布2012/0080332)；US Patent Application Serial No. 12/894,306 (now US Patent Publication 2012/0080332), 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(现为美国专利公布2012/0080480)；U.S. Patent Application Serial No. 12/894,318, entitled "FASTENER SYSTEM COMPRISING A PLURALITY OF CONNECTED RETENTIONMATRIX ELEMENTS" (now U.S. Patent Publication 2012/0080480);
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(现为美国专利公布2012/0080503)；U.S. Patent Application Serial No. 12/894,330, entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENTMATRIX" (now U.S. Patent Publication 2012/0080503);
名称为“FASTENER SYSTEM COMPRISING A RETENTION MATRIX”的美国专利申请序列号12/894,361(现为美国专利8,529,600)；U.S. Patent Application Serial No. 12/894,361, entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX" (now U.S. Patent 8,529,600);
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(现为美国专利公布2012/0080485)；U.S. Patent Application Serial No. 12/894,367, entitled "FASTENING INSTRUMENT FOR DEPLOYING A FASTENER SYSTEMCOMPRISING A RETENTION MATRIX" (now U.S. Patent Publication 2012/0080485);
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(现为美国专利8,474,677)；U.S. Patent Application Serial No. 12/894,388, entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND A COVER" (now U.S. Patent 8,474,677);
名称为“FASTENER SYSTEM COMPRISING A PLURALITY OF FASTENER CARTRIDGES”的美国专利申请序列号12/894,376(现为美国专利公布2012/0080486)；U.S. Patent Application Serial No. 12/894,376, entitled "FASTENER SYSTEM COMPRISING A PLURALITY OF FASTENER CARTRIDGES" (now U.S. Patent Publication 2012/0080486);
名称为“SURGICAL STAPLER ANVIL COMPRISING A PLURALITY OF FORMINGPOCKETS”的美国专利申请序列号13/097,865(现为美国专利公布2012/0080488)；US Patent Application Serial No. 13/097,865 (now US Patent Publication 2012/0080488) 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(现为美国专利公布2012/0080339)；US Patent Application Serial No. 13/097,936 (now US Patent Publication 2012/0080339), 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(现为美国专利公布2012/0080340)；U.S. Patent Application Serial No. 13/097,954 (now U.S. Patent Publication 2012/0080340), 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(现为美国专利公布2012/0080336)；US Patent Application Serial No. 13/097,856 (now US Patent Publication 2012/0080336), 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(现为美国专利公布2012/0080490)；US Patent Application Serial No. 13/097,928 (now US Patent Publication 2012/0080490) 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(现为美国专利公布2012/0080489)；US Patent Application Serial No. 13/097,891 (now US Patent Publication 2012/0080489) 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(现为美国专利公布2012/0083836)；US Patent Application Serial No. 13/097,948 (now US Patent Publication 2012/0083836), entitled "STAPLE CARTRIDGE COMPRISING AN ADJUSTABLE DISTAL PORTION";
名称为“COMPRESSIBLE STAPLE CARTRIDGE ASSEMBLY”的美国专利申请序列号13/097,907(现为美国专利公布2012/0080338)；US Patent Application Serial No. 13/097,907 (now US Patent Publication 2012/0080338), 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(现为美国专利公布2012/0080337)；US Patent Application Serial No. 13/097,861 (now US Patent Publication 2012/0080337) 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(现为美国专利公布2012/0160721)；U.S. Patent Application Serial No. 13/097,869 (now U.S. Patent Publication 2012/0160721), 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(现为美国专利公布2012/0083834)；US Patent Application Serial No. 13/097,917, entitled "COMPRESSIBLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS" (now US Patent Publication 2012/0083834);
名称为“STAPLE CARTRIDGE COMPRISING A RELEASABLE PORTION”的美国专利申请序列号13/097,873(现为美国专利公布2012/0083833)；U.S. Patent Application Serial No. 13/097,873, entitled "STAPLE CARTRIDGE COMPRISING A RELEASABLE PORTION" (now U.S. Patent Publication 2012/0083833);
名称为“STAPLE CARTRIDGE COMPRISING COMPRESSIBLE DISTORTION RESISTANTCOMPONENTS”的美国专利申请序列号13/097,938(现为美国专利公布2012/0080491)；US Patent Application Serial No. 13/097,938 (now US Patent Publication 2012/0080491), 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(现为美国专利公布2012/0083835)；US Patent Application Serial No. 13/097,924 (now US Patent Publication 2012/0083835), 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(现为美国专利公布2012/0080493)；US Patent Application Serial No. 13/242,029 (now US Patent Publication 2012/0080493), 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(现为美国专利公布2012/0080498)；U.S. Patent Application Serial No. 13/242,066, entitled "CURVED END EFFECTOR FOR A STAPLING INSTRUMENT" (now U.S. Patent Publication 2012/0080498);
名称为“STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK”的美国专利申请序列号13/242,086(现为美国专利公布2013/0075450)；US Patent Application Serial No. 13/242,086 (now US Patent Publication 2013/0075450), 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(现为美国专利公布2013/0075448)；US Patent Application Serial No. 13/241,912 (now US Patent Publication 2013/0075448), 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(现为美国专利公布2013/0075449)；US Patent Application Serial No. 13/241,922 entitled "SURGICAL STAPLER WITH STATIONARY STAPLE DRIVERS" (now US Patent Publication 2013/0075449);
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(现为美国专利公布2012/0074201)；US Patent Application Serial No. 13/241,637 (now US Patent Publication 2012/0074201) entitled "SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATING MULTIPLE ACTUATION MOTIONS";
名称为“SURGICAL INSTRUMENT WITH SELECTIVELY ARTICULATABLE ENDEFFECTOR”的美国专利申请序列号13/241,629(现为美国专利公布2012/0074200)；US Patent Application Serial No. 13/241,629 (now US Patent Publication 2012/0074200) entitled "SURGICAL INSTRUMENT WITH SELECTIVELY ARTICULATABLE ENDEFFECTOR";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OFCAPSULES”的美国专利申请序列号13/433,096(现为美国专利公布2012/0241496)；US Patent Application Serial No. 13/433,096 (now US Patent Publication 2012/0241496), 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13/433,103(现为美国专利公布2012/0241498)；US Patent Application Serial No. 13/433,103 (now US Patent Publication 2012/0241498) 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13/433,098(现为美国专利公布2012/0241491)；US Patent Application Serial No. 13/433,098 (now US Patent Publication 2012/0241491), entitled "EXPANDABLE TISSUE THICKNESS COMPENSATOR";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING A RESERVOIR”的美国专利申请序列号13/433,102(现为美国专利公布2012/0241497)；US Patent Application Serial No. 13/433,102 (now US Patent Publication 2012/0241497), 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13/433,114(现为美国专利公布2012/0241499)；US Patent Application Serial No. 13/433,114 (now US Patent Publication 2012/0241499), entitled "RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESS COMPENSATOR";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING AT LEAST ONEMEDICAMENT”的美国专利申请序列号13/433,136(现为美国专利公布2012/0241492)；US Patent Application Serial No. 13/433,136 (now US Patent Publication 2012/0241492) entitled "TISSUE THICKNESS COMPENSATOR COMPRISING AT LEAST ONEMEDICAMENT";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING CONTROLLED RELEASE ANDEXPANSION”的美国专利申请序列号13/433,141(现为美国专利公布2012/0241493)；US Patent Application Serial No. 13/433,141 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING CONTROLLED RELEASE ANDEXPANSION" (now US Patent Publication 2012/0241493);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING FIBERS TO PRODUCE ARESILIENT LOAD”的美国专利申请序列号13/433,144(现为美国专利公布2012/0241500)；US Patent Application Serial No. 13/433,144 (now US Patent Publication 2012/0241500), entitled "TISSUE THICKNESS COMPENSATOR COMPRISING FIBERS TO PRODUCE ARESILIENT LOAD";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING STRUCTURE TO PRODUCE ARESILIENT LOAD”的美国专利申请序列号13/433,148(现为美国专利公布2012/0241501)；US Patent Application Serial No. 13/433,148 (now US Patent Publication 2012/0241501) 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13/433,155(现为美国专利公布2012/0241502)；US Patent Application Serial No. 13/433,155 (now US Patent Publication 2012/0241502) 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13/433,163(现为美国专利公布2012/0248169)；U.S. Patent Application Serial No. 13/433,163 (now U.S. Patent Publication 2012/0248169) 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13/433,167(现为美国专利公布2012/0241503)；US Patent Application Serial No. 13/433,167 (now US Patent Publication 2012/0241503) entitled "TISSUE THICKNESS COMPENSATORS";
名称为“LAYERED TISSUE THICKNESS COMPENSATOR”的美国专利申请序列号13/433,175(现为美国专利公布2012/0253298)；US Patent Application Serial No. 13/433,175 (now US Patent Publication 2012/0253298) 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13/433,179(现为美国专利公布2012/0241505)；US Patent Application Serial No. 13/433,179 (now US Patent Publication 2012/0241505) entitled "TISSUE THICKNESS COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS";
名称为“ADHESIVE FILM LAMINATE”的美国专利申请序列号13/763,028(现为美国专利公布2013/0146643)；US Patent Application Serial No. 13/763,028 (now US Patent Publication 2013/0146643), entitled "ADHESIVE FILM LAMINATE";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING CAPSULES DEFINING ALOW PRESSURE ENVIRONMENT”的美国专利申请序列号13/433,115(现为美国专利公布2013/0256372)；US Patent Application Serial No. 13/433,115 (now US Patent Publication 2013/0256372) 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13/433,118(现为美国专利公布2013/0256365)；U.S. Patent Application Serial No. 13/433,118 (now U.S. Patent Publication 2013/0256365) 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13/433,135(现为美国专利公布2013/0256382)；US Patent Application Serial No. 13/433,135 (now US Patent Publication 2013/0256382) entitled "MOVABLE MEMBER FOR USE WITH A TISSUE THICKNESS COMPENSATOR";
名称为“TISSUE THICKNESS COMPENSATOR AND METHOD FOR MAKING THE SAME”的美国专利申请序列号13/433,140(现为美国专利公布2013/0256368)；US Patent Application Serial No. 13/433,140 (now US Patent Publication 2013/0256368) entitled "TISSUE THICKNESS COMPENSATOR AND METHOD FOR MAKING THE SAME";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OFMEDICAMENTS”的美国专利申请序列号13/433,129(现为美国专利公布2013/0256367)；US Patent Application Serial No. 13/433,129 (now US Patent Publication 2013/0256367) entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OFMEDICAMENTS";
名称为“STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMEDSTAPLE HEIGHTS”的美国专利申请序列号11/216,562(现为美国专利7,669,746)；U.S. Patent Application Serial No. 11/216,562, entitled "STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMEDSTAPLE HEIGHTS" (now U.S. Patent 7,669,746);
名称为“SURGICAL STAPLING DEVICE WITH ANVIL HAVING STAPLE FORMINGPOCKETS OF VARYING DEPTHS”的美国专利申请序列号11/714,049(现为美国专利公布2007/0194082)；U.S. Patent Application Serial No. 11/714,049 (now U.S. Patent Publication 2007/0194082) entitled "SURGICAL STAPLING DEVICE WITH ANVIL HAVING STAPLE FORMINGPOCKETS OF VARYING DEPTHS";
名称为“SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVINGDIFFERENT LENGTHS”的美国专利申请序列号11/711,979(现为美国专利8,317,070)；US Patent Application Serial No. 11/711,979 (now US Patent 8,317,070) entitled "SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS";
名称为“SURGICAL STAPLING DEVICE WITH STAPLE DRIVERS OF DIFFERENTHEIGHT”的美国专利申请序列号11/711,975(现为美国专利公布2007/0194079)；US Patent Application Serial No. 11/711,975 (now US Patent Publication 2007/0194079), entitled "SURGICAL STAPLING DEVICE WITH STAPLE DRIVERS OF DIFFERENTHEIGHT";
名称为“SURGICAL STAPLING DEVICE WITH STAPLE DRIVER THAT SUPPORTSMULTIPLE WIRE DIAMETER STAPLES”的美国专利申请序列号11/711,977(现为美国专利7,673,781)；US Patent Application Serial No. 11/711,977 (now US Patent 7,673,781) entitled "SURGICAL STAPLING DEVICE WITH STAPLE DRIVER THAT SUPPORTSMULTIPLE WIRE DIAMETER STAPLES";
名称为“SURGICAL STAPLING DEVICE WITH MULTIPLE STACKED ACTUATOR WEDGECAMS FOR DRIVING STAPLE DRIVERS”的美国专利申请序列号11/712,315(现为美国专利7,500,979)；US Patent Application Serial No. 11/712,315 (now US Patent 7,500,979) entitled "SURGICAL STAPLING DEVICE WITH MULTIPLE STACKED ACTUATOR WEDGECAMS FOR DRIVING STAPLE DRIVERS";
名称为“STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMEDSTAPLE HEIGHTS”的美国专利申请序列号12/038,939(现为美国专利7,934,630)；US Patent Application Serial No. 12/038,939 (now US Patent 7,934,630), entitled "STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMEDSTAPLE HEIGHTS";
名称为“SURGICAL STAPLING SYSTEMS THAT PRODUCE FORMED STAPLES HAVINGDIFFERENT LENGTHS”的美国专利申请序列号13/020,263(现为美国专利公布2011/0147434)；US Patent Application Serial No. 13/020,263 (now US Patent Publication 2011/0147434) entitled "SURGICAL STAPLING SYSTEMS THAT PRODUCE FORMED STAPLES HAVINGDIFFERENT LENGTHS";
名称为“ROBOTICALLY-CONTROLLED SURGICAL STAPLING DEVICES THAT PRODUCEFORMED STAPLES HAVING DIFFERENT LENGTHS”的美国专利申请序列号13/118,278(现为美国专利公布2011/0290851)；U.S. Patent Application Serial No. 13/118,278 (now U.S. Patent Publication 2011/0290851) entitled "ROBOTICALLY-CONTROLLED SURGICAL STAPLING DEVICES THAT PRODUCEFORMED STAPLES HAVING DIFFERENT LENGTHS";
名称为“ROBOTICALLY-CONTROLLED CABLE-BASED SURGICAL END EFFECTORS”的美国专利申请序列号13/369,629(现为美国专利公布2012/0138660)；US Patent Application Serial No. 13/369,629 (now US Patent Publication 2012/0138660), entitled "ROBOTICALLY-CONTROLLED CABLE-BASED SURGICAL END EFFECTORS";
名称为“SURGICAL STAPLING DEVICES FOR FORMING STAPLES WITH DIFFERENTFORMED HEIGHTS”的美国专利申请序列号12/695,359(现为美国专利8,464,923)；US Patent Application Serial No. 12/695,359 (now US Patent 8,464,923), entitled "SURGICAL STAPLING DEVICES FOR FORMING STAPLES WITH DIFFERENTFORMED HEIGHTS";
名称为“STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMEDSTAPLE HEIGHTS”的美国专利申请序列号13/072,923(现为美国专利8,567,656)；US Patent Application Serial No. 13/072,923 (now US Patent 8,567,656), entitled "STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMEDSTAPLE HEIGHTS";
名称为“LAYER OF MATERIAL FOR A SURGICAL END EFFECTOR”的美国专利申请序列号13/766,325(现为美国专利公布2013/0256380)；U.S. Patent Application Serial No. 13/766,325 (now U.S. Patent Publication 2013/0256380), entitled "LAYER OF MATERIAL FOR A SURGICAL END EFFECTOR";
名称为“ANVIL LAYER ATTACHED TO A PROXIMAL END OF AN END EFFECTOR”的美国专利申请序列号13/763,078(现为美国专利公布2013/0256383)；US Patent Application Serial No. 13/763,078 (now US Patent Publication 2013/0256383), entitled "ANVIL LAYER ATTACHED TO A PROXIMAL END OF AN END EFFECTOR";
名称为“LAYER COMPRISING DEPLOYABLE ATTACHMENT MEMBERS”的美国专利申请序列号13/763,094(现为美国专利公布2013/0256377)；US Patent Application Serial No. 13/763,094 (now US Patent Publication 2013/0256377), entitled "LAYER COMPRISING DEPLOYABLE ATTACHMENT MEMBERS";
名称为“END EFFECTOR COMPRISING A DISTAL TISSUE ABUTMENT MEMBER”的美国专利申请序列号13/763,106(现为美国专利公布2013/0256378)；US Patent Application Serial No. 13/763,106, entitled "END EFFECTOR COMPRISING A DISTAL TISSUE ABUTMENT MEMBER" (now US Patent Publication 2013/0256378);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING CHANNELS”的美国专利申请序列号13/433,147(现为美国专利公布2013/0256369)；US Patent Application Serial No. 13/433,147 (now US Patent Publication 2013/0256369) entitled "TISSUE THICKNESS COMPENSATOR COMPRISING CHANNELS";
名称为“SURGICAL STAPLING CARTRIDGE WITH LAYER RETENTION FEATURES”的美国专利申请序列号13/763,112(现为美国专利公布2013/0256379)；US Patent Application Serial No. 13/763,112 entitled "SURGICAL STAPLING CARTRIDGE WITH LAYER RETENTION FEATURES" (now US Patent Publication 2013/0256379);
名称为“ACTUATOR FOR RELEASING A TISSUE THICKNESS COMPENSATOR FROM AFASTENER CARTRIDGE”的美国专利申请序列号13/763,035(现为美国专利公布2013/0214030)；U.S. Patent Application Serial No. 13/763,035 (now U.S. Patent Publication 2013/0214030) entitled "ACTUATOR FOR RELEASING A TISSUE THICKNESS COMPENSATOR FROM AFASTENER CARTRIDGE";
名称为“RELEASABLE TISSUE THICKNESS COMPENSATOR AND FASTENER CARTRIDGEHAVING THE SAME”的美国专利申请序列号13/763,042(现为美国专利公布2013/0221063)；US Patent Application Serial No. 13/763,042 (now US Patent Publication 2013/0221063) entitled "RELEASABLE TISSUE THICKNESS COMPENSATOR AND FASTENER CARTRIDGE HAVING THE SAME";
名称为“FASTENER CARTRIDGE COMPRISING A RELEASABLE TISSUE THICKNESSCOMPENSATOR”的美国专利申请序列号13/763,048(现为美国专利公布2013/0221064)；U.S. Patent Application Serial No. 13/763,048 (now U.S. Patent Publication 2013/0221064), entitled "FASTENER CARTRIDGE COMPRISING A RELEASABLE TISSUE THICKNESSCOMPENSATOR";
名称为“FASTENER CARTRIDGE COMPRISING A CUTTING MEMBER FOR RELEASING ATISSUE THICKNESS COMPENSATOR”的美国专利申请序列号13/763,054；US Patent Application Serial No. 13/763,054, entitled "FASTENER CARTRIDGE COMPRISING A CUTTING MEMBER FOR RELEASING ATISSUE THICKNESS COMPENSATOR";
名称为“FASTENER CARTRIDGE COMPRISING A RELEASABLY ATTACHED TISSUETHICKNESS COMPENSATOR”的美国专利申请序列号13/763,065(现为美国专利公布2013/0221065)；U.S. Patent Application Serial No. 13/763,065 (now U.S. Patent Publication 2013/0221065), entitled "FASTENER CARTRIDGE COMPRISING A RELEASABLY ATTACHED TISSUETHICKNESS COMPENSATOR";
名称为“STAPLE CARTRIDGE COMPRISING A RELEASABLE COVER”的美国专利申请序列号13/763,021；US Patent Application Serial No. 13/763,021, entitled "STAPLE CARTRIDGE COMPRISING A RELEASABLE COVER";
名称为“ANVIL LAYER ATTACHED TO A PROXIMAL END OF AN END EFFECTOR”的美国专利申请序列号13/763,078(现为美国专利公布2013/0256383)；US Patent Application Serial No. 13/763,078 (now US Patent Publication 2013/0256383), entitled "ANVIL LAYER ATTACHED TO A PROXIMAL END OF AN END EFFECTOR";
名称为“LAYER ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES”的美国专利申请序列号13/763,095(现为美国专利公布2013/0161374)；US Patent Application Serial No. 13/763,095 (now US Patent Publication 2013/0161374) entitled "LAYER ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES";
名称为“IMPLANTABLE ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES”的美国专利申请序列号13/463,147(现为美国专利公布2013/0292398)；U.S. Patent Application Serial No. 13/463,147, entitled "IMPLANTABLE ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES" (now U.S. Patent Publication 2013/0292398);
名称为“MULTIPLE THICKNESS IMPLANTABLE LAYERS FOR SURGICAL STAPLINGDEVICES”的美国专利申请序列号13/763,192(现为美国专利公布2013/0146642)；US Patent Application Serial No. 13/763,192 (now US Patent Publication 2013/0146642), entitled "MULTIPLE THICKNESS IMPLANTABLE LAYERS FOR SURGICAL STAPLING DEVICES";
名称为“RELEASABLE LAYER OF MATERIAL AND SURGICAL END EFFECTOR HAVINGTHE SAME”的美国专利申请序列号13/763,161(现为美国专利公布2013/0153641)；U.S. Patent Application Serial No. 13/763,161, entitled "RELEASABLE LAYER OF MATERIAL AND SURGICAL END EFFECTOR HAVINGTHE SAME" (now U.S. Patent Publication 2013/0153641);
名称为“ACTUATOR FOR RELEASING A LAYER OF MATERIAL FROM A SURGICAL ENDEFFECTOR”的美国专利申请序列号13/763,177(现为美国专利公布2013/0146641)；U.S. Patent Application Serial No. 13/763,177, entitled "ACTUATOR FOR RELEASING A LAYER OF MATERIAL FROM A SURGICAL ENDEFFECTOR" (now U.S. Patent Publication 2013/0146641);
名称为“STAPLE CARTRIDGE COMPRISING A COMPRESSIBLE PORTION”的美国专利申请序列号13/763,037；US Patent Application Serial No. 13/763,037, entitled "STAPLE CARTRIDGE COMPRISING A COMPRESSIBLE PORTION";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING TISSUE INGROWTHFEATURES”的美国专利申请序列号13/433,126(现为美国专利公布2013/0256366)；US Patent Application Serial No. 13/433,126 (now US Patent Publication 2013/0256366), entitled "TISSUE THICKNESS COMPENSATOR COMPRISING TISSUE INGROWTH FEATURES";
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13/433,132(现为美国专利公布2013/0256373)。US Patent Application Serial No. 13/433,132 (now US Patent Publication 2013/0256373) entitled "DEVICES AND METHODS FOR ATTACHING TISSUE THICKNESS COMPENSATING MATERIALS TO SURGICAL STAPLING INSTRUMENTS."
名称为“FASTENER CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATORINCLUDING OPENINGS THEREIN”的美国专利申请序列号13/851,703；US Patent Application Serial No. 13/851,703, entitled "FASTENER CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATORINCLUDING OPENINGS THEREIN";
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING A CUTTING MEMBER PATH”的美国专利申请序列号13/851,676；US Patent Application Serial No. 13/851,676, entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A CUTTING MEMBER PATH";
名称为“FASTENER CARTRIDGE ASSEMBLIES”的美国专利申请序列号13/851,693；以及U.S. Patent Application Serial No. 13/851,693, entitled "FASTENER CARTRIDGE ASSEMBLIES"; and
名称为“FASTENER CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATORAND A GAP SETTING ELEMENT”的美国专利申请序列号13/851,684。US Patent Application Serial No. 13/851,684, entitled "FASTENER CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATORAND A GAP SETTING ELEMENT."
本申请的申请人还拥有以下专利申请，所述专利申请与本申请同一天提交并且全文各自以引用方式并入本文：The applicant of the present application also owns the following patent applications, which were filed on the same date as the present application and each of which is incorporated herein by reference in its entirety:
名称为“STAPLE CARTRIDGE INCLUDING A BARBED STAPLE”的美国专利申请序列号__________(代理人案卷号END7439USNP)；U.S. Patent Application Serial No. __________ (Attorney Docket No. END7439USNP) entitled "STAPLE CARTRIDGE INCLUDING A BARBED STAPLE";
名称为“STAPLE CARTRIDGE INCLUDING A BARBED STAPLE”的美国专利申请序列号__________(代理人案卷号END7441USNP)；U.S. Patent Application Serial No. __________ (Attorney Docket No. END7441USNP) entitled "STAPLE CARTRIDGE INCLUDING A BARBED STAPLE";
名称为“IMPLANTABLE LAYERS COMPRISING A PRESSED REGION”的美国专利申请序列号__________(代理人案卷号END7349USNP/130323)；U.S. Patent Application Serial No. __________ (Attorney Docket No. END7349USNP/130323) entitled "IMPLANTABLE LAYERS COMPRISING A PRESSED REGION";
名称为“IMPLANTABLE LAYERS AND METHODS FOR ALTERING ONE OR MOREPROPERTIES OF IMPLANTABLE LAYERS FOR USE WITH FASTENING INSTRUMENTS”的美国专利申请序列号__________(代理人案卷号END7348USNP/130324)；U.S. Patent Application Serial No. __________ (Attorney Docket No. END7348USNP/130324) entitled "IMPLANTABLE LAYERS AND METHODS FOR ALTERING ONE OR MORE PROPERTIES OF IMPLANTABLE LAYERS FOR USE WITH FASTENING INSTRUMENTS";
名称为“IMPLANTABLE LAYERS AND METHODS FOR MODIFYING THE SHAPE OF THEIMPLANTABLE LAYERS FOR USE WITH A SURGICAL FASTENING INSTRUMENT”的美国专利申请序列号__________(代理人案卷号END7347USNP/130325)；U.S. Patent Application Serial No. __________ (Attorney Docket No. END7347USNP/130325) entitled "IMPLANTABLE LAYERS AND METHODS FOR MODIFYING THE SHAPE OF THE IMPLANTABLE LAYERS FOR USE WITH A SURGICAL FASTENING INSTRUMENT";
名称为“IMPLANTABLE LAYER ASSEMBLIES”的美国专利申请序列号__________(代理人案卷号END7346USNP/130326)；U.S. Patent Application Serial No. __________ (Attorney Docket No. END7346USNP/130326) entitled "IMPLANTABLE LAYER ASSEMBLIES";
名称为“IMPLANTABLE LAYERS COMPRISING A PRESSED REGION”的美国专利申请序列号__________(代理人案卷号END7345USNP/130327)；以及U.S. Patent Application Serial No. __________ (Attorney Docket No. END7345USNP/130327) entitled "IMPLANTABLE LAYERS COMPRISING A PRESSED REGION"; and
名称为“FASTENING SYSTEM COMPRISING A FIRING MEMBER LOCKOUT”的美国专利申请序列号__________(代理人案卷号END7350USNP/130328)。US Patent Application Serial No. __________ (Attorney Docket No. END7350USNP/130328) entitled "FASTENING SYSTEM COMPRISING A FIRING MEMBER LOCKOUT."
现在将描述某些示例性实施方案，以从整体上理解本文所公开的装置和方法的结构、功能、制造和使用的原理。这些实施方案的一个或多个示例在附图中示出。本领域的普通技术人员将会理解，在本文中具体描述并示出于附图中的装置和方法为非限制性的示例性实施方案，并且本发明的多个实施方案的范围仅由权利要求书限定。结合一个示例性实施方案示出或描述的特征可与其他实施方案的特征进行组合。此类修改和变型旨在包括在本发明的范围内。Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these implementations are illustrated in the accompanying drawings. Those of ordinary skill in the art will appreciate that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the various embodiments of the present invention is limited only by the claims Book limited. Features shown or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
术语“包括”(以及包括的任何形式，诸如“包括(comprises)”和“包括(comprising)”)、“具有”(和具有的任何形式，诸如“具有(has)”和“具有(having)”)、“包含”(和包含的任何形式，诸如“包含(includes)”、和“包含(including)”以及“含有”(和含有的任何形式，诸如“含有(contains)”和“含有(containing)”)为开放式系动词。因此，“包括”、“具有”、“包含”或“含有”一个或多个元件的外科系统、装置、或设备具有这些一个或多个元件，但不限于仅具有这些一个或多个元件。同样，“包括”、“具有”、“包含”或“含有”一个或多个特征的系统、装置、或设备的元件具有这些一个或多个特征，但不限于仅具有这些一个或多个特征。The terms "comprise" (and any form of including, such as "comprises" and "comprising"), "having" (and any form of having, such as "has" and "having "), "comprises" (and any form of inclusion, such as "includes", and "including" and "containing" (and any form of containment, such as "contains" and "contains ( containing)") is an open-ended copula. Thus, a surgical system, device, or device that "comprises," "has," "comprises," or "contains" one or more elements has those one or more elements, but does not is limited to having only these one or more elements. Likewise, an element of a system, device, or device that "comprises", "has", "comprises" or "contains" one or more features has these one or more features, but Not limited to having only one or more of these features.
术语“近侧”和“远侧”在本文中是相对于操纵外科器械的柄部部分的临床医生来使用的。术语“近侧”是指最靠近临床医生的部分，并且术语“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，外科器械在许多取向和位置中使用，并且这些术语并非限制性和/或绝对化的。The terms "proximal" and "distal" are used herein with respect to the 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 intended to be limiting and/or absolute.
提供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，本领域的普通技术人员将容易理解，本文所公开的各种方法和装置可用于许多外科手术和应用中，包括例如与开放式外科手术相结合。继续参阅本具体实施方式，本领域中的普通技术人员将进一步理解，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, those of ordinary skill in the art will readily appreciate that the various methods and devices disclosed herein may be used in many surgical procedures and applications, including, for example, in conjunction with open surgery. Continuing to refer to the detailed description, those skilled in the art will further understand that various instruments disclosed herein can be inserted into the body in any way, such as through natural orifices, through incisions or puncture holes formed in tissues, 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，其中在所有附图中相似编号指示相似部件，图1示出适于与组织厚度补偿件组件一起使用的示例性外科缝合和切断器械8010，如下文中更详细地描述。外科缝合和切断器械8010可包括砧座8014，该砧座可围绕其到细长钉通道8016的枢转附接而被反复打开和闭合。钉施用组件8012可包括砧座8014和通道8016，其中组件8012可朝近侧附接到形成工具部分8022的细长轴8018。当钉施用组件8012闭合时、或至少基本上闭合时，执行部分8022可呈现足够小的横截面，该横截面适于将钉施用组件8012穿过套管针插入。在各种情况下，组件8012可由连接至轴8018的柄部8020操纵。柄部8020可包括用户控件诸如旋钮8030，该旋钮使细长轴8018和钉施用组件8012围绕轴8018的纵向轴线旋转。闭合触发器8026可在手枪式握把8036前方枢转以闭合钉施用组件8012。例如，当闭合触发器8026被夹紧时，闭合释放按钮8038可向外存在于柄部8020上，使得释放按钮8038可被压下以松开闭合触发器8026并打开钉施用组件8012。可在闭合触发器8026前方枢转的击发触发器8034可使钉施用组件8012同时切断和缝合被夹紧在其中的组织。在各种情况下，可使用击发触发器8034来采用多个击发行程以减少每行程需要由外科医生的手施加的力的大小。在某些实施方案中，柄部8020可包括一个或多个可旋转指示器轮，诸如可指示击发进程的可旋转指示器轮8041。如果需要，手动击发释放杠杆8042可允许击发系统在完全击发行进完成之前回缩，并且此外，在击发系统卡住和/或失效的情况下，击发释放杠杆8042可允许外科医生或其他临床医生使击发系统回缩。关于外科缝合和切断器械8010和适于与本公开一起使用的其他外科缝合和切断器械的附加细节例如在2013年3月27日提交的名称为“FASTENERCARTRIDGE ASSEMBLY”的美国专利申请13/851,693中有所描述，该专利的全部公开内容以引用方式并入本文。此外，通电的外科缝合和切断器械也可与本公开一起使用。参见例如2008年8月8日提交的名称为“POWERED SURGICAL STAPLING DEVICE”的美国专利申请公布2009/0090763 A1，该专利的全部公开内容以引用方式并入本文。Turning to the drawings, in which like numerals indicate like parts throughout, Figure 1 illustrates an exemplary surgical stapling and severing instrument 8010 suitable for use with a tissue thickness compensator assembly, as described in more detail below. The surgical stapling and severing instrument 8010 can include an anvil 8014 that can be repeatedly opened and closed about its pivotal attachment to the elongated staple channel 8016. Staple applying assembly 8012 can include an anvil 8014 and a channel 8016, wherein assembly 8012 can be attached proximally to an elongated shaft 8018 forming tool portion 8022. When the staple applying assembly 8012 is closed, or at least substantially closed, the actuating portion 8022 can exhibit a sufficiently small cross-section suitable for insertion of the staple applying assembly 8012 through a trocar. In various cases, assembly 8012 can be manipulated by handle 8020 connected to shaft 8018 . The handle 8020 can include user controls such as a knob 8030 that rotates the elongated shaft 8018 and staple applying assembly 8012 about the longitudinal axis of the shaft 8018. A closure trigger 8026 can pivot forward of the pistol grip 8036 to close the staple applying assembly 8012. For example, when the closure trigger 8026 is clamped, a closure release button 8038 can be present outwardly on the handle 8020 such that the release button 8038 can be depressed to release the closure trigger 8026 and open the staple applying assembly 8012. A firing trigger 8034 pivotable forward of the closure trigger 8026 can cause the staple applying assembly 8012 to simultaneously sever and staple tissue clamped therein. In various circumstances, multiple firing strokes may be employed using the firing trigger 8034 to reduce the amount of force that needs to be applied by the surgeon's hand per stroke. In certain embodiments, the handle 8020 can include one or more rotatable indicator wheels, such as the rotatable indicator wheel 8041 that can indicate the progress of the firing. If desired, the manual firing release lever 8042 can allow the firing system to retract before full firing progression is complete, and in addition, the firing release lever 8042 can allow the surgeon or other clinician to Retracts the firing system. Additional details regarding the surgical stapling and severing instrument 8010 and other surgical stapling and severing instruments suitable for use with the present disclosure are found, for example, in U.S. Patent Application 13/851,693, filed March 27, 2013, entitled "FASTENER CARTRIDGE ASSEMBLY." described, the entire disclosure of this patent is incorporated herein by reference. Additionally, powered surgical stapling and cutting instruments may also be used with the present disclosure. See, eg, US Patent Application Publication 2009/0090763 Al, filed August 8, 2008, entitled "POWERED SURGICAL STAPLING DEVICE," the entire disclosure of which is incorporated herein by reference.
结合图2和图3，击发组件(诸如击发组件9090)可与外科缝合和切断器械8010一起使用以推进包括多个楔形件9204的楔形滑动件9126，所述楔形件被构造成能够将钉从钉施用组件8012部署到捕获在砧座8014和细长钉通道8016之间的组织中。此外，在击发组件9090的远侧部分处的E形梁9102可有利于单独闭合和击发，以及在击发期间将砧座8014与细长钉通道8016间隔开。E形梁9102可包括一对顶部销9110，可跟随楔形滑动件9126的部分9218的一对中间销9112，和底部销或支脚9114，以及锋利的切割刃9116，该切割刃可被构造成能够在击发组件9090朝远侧推进时切断所捕获的组织。此外，托住切割刃9116的每个垂直端的朝近侧突出的一体成型顶部导向件9118和中间导向件9120可进一步限定组织集结区域9122，从而有助于在切断组织前将组织引导至锋利的切割刃9116。中间导向件9120还可用于通过邻接楔形滑动件9126(图2)的阶梯式中央构件9124来接合并击发钉施用组件8012，所述楔形滑动件通过钉施用组件8012影响钉成形。2 and 3, a firing assembly such as firing assembly 9090 may be used with surgical stapling and severing instrument 8010 to advance wedge sled 9126 comprising a plurality of wedges 9204 configured to drive staples from Staple applying assembly 8012 is deployed into tissue captured between anvil 8014 and elongated staple channel 8016. Additionally, the E-beam 9102 at the distal portion of the firing assembly 9090 can facilitate separate closure and firing, as well as space the anvil 8014 from the elongated staple channel 8016 during firing. The E-beam 9102 can include a pair of top pins 9110, a pair of middle pins 9112 that can follow a portion 9218 of a wedge slide 9126, and a bottom pin or foot 9114, as well as a sharp cutting edge 9116 that can be configured to Captured tissue is severed as the firing assembly 9090 is advanced distally. In addition, the proximally projecting integrally formed top guide 9118 and middle guide 9120 that hold each vertical end of the cutting edge 9116 can further define a tissue nucleation area 9122 to help guide tissue to the sharp edge prior to severing the tissue. Cutting edge 9116. Intermediate guide 9120 can also be used to engage and fire staple applicator assembly 8012 by abutting stepped central member 9124 of wedge sled 9126 ( FIG. 2 ), which affects staple formation through staple applicator assembly 8012 .
在各种情况下，钉仓可包括用于对捕获在从钉仓部署的钉内的组织的厚度进行补偿的装置。参见图4，钉仓(诸如钉仓10000)例如可与外科缝合和切断器械8010一起使用并且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)。支撑部分10010可包括仓体和多个钉腔10012。钉10030例如可以可移除地定位在每个钉腔10012中。主要参见图4和图5，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，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可至少部分地容纳在钉腔10012内。在各种情况下，钉10030可被部署在未击发位置与击发位置之间，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，并且接触与钉仓10000相对定位的砧座。在腿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，在该钉截留区域中，组织T和组织厚度补偿件10020可被捕获。在各种情况下，钉截留区域可被限定在已变形的腿10032的内表面与基部10031的内表面之间。钉截留区域的尺寸可取决于若干因素，诸如腿的长度、腿的直径、基部的宽度和/或腿部变形的程度。In various circumstances, the staple cartridge can include means for compensating for the thickness of tissue trapped within the staples deployed from the staple cartridge. 4, a staple cartridge such as staple cartridge 10000 may be used, for example, with a surgical stapling and severing instrument 8010 and may include a rigid first portion, such as a support portion 10010, and a compressible second portion, such as a tissue thickness compensator 10020. ). The support portion 10010 can include a cartridge body and a plurality of staple cavities 10012 . Staples 10030 can be removably positioned within each staple cavity 10012, for example. Referring primarily to FIGS. 4 and 5 , each staple 10030 can include a base 10031 and one or more legs 10032 extending from the base 10031 . Before the staples 10030 are deployed, the bases 10031 of the staples 10030 can be supported by the 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. In various circumstances, the staples 10030 can be deployed between the unfired position and the 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 Contacts an anvil positioned opposite the staple cartridge 10000. As 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 in which the tissue T and tissue thickness compensator 10020 can be captured. In various circumstances, a staple entrapment region 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.
在使用中，对上文进行进一步描述并且主要参见图4，外科缝合和切断器械8010的砧座诸如砧座8014可通过按压闭合触发器8026而运动到与钉仓10000相对的闭合位置中以推进E形梁9102。砧座8014可将组织抵靠组织厚度补偿件10020定位，并且在各种情况下，例如将组织厚度补偿件10020抵靠支撑部分10010压缩。一旦砧座8014已适当定位，则可部署钉10030，同样如图4所示。在各种情况下，如上所述，在许多方面类似于滑动件9126(参见图3)的钉击发滑动件10050可从钉仓10000的近侧端部朝远侧端部10002运动，如图5所示。当击发组件9090被推进时，滑动件10050可接触钉驱动器10040并在钉腔10012内向上提升钉驱动器10040。在至少一个示例中，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，所述一个或多个斜坡或倾斜表面可协作以使钉驱动器10040从它们的未击发位置向上运动。钉驱动器10040在它们各自的钉腔10012内被向上提升时，钉驱动器10040可向上提升钉10030，使得钉10030可从其钉腔10012出现。在各种情况下，作为击发序列的一部分，滑动件10050可同时使若干钉向上运动。In use, further described above and referring primarily to FIG. 4 , an anvil of surgical stapling and severing instrument 8010 , such as anvil 8014 , can be moved into a closed position opposite staple cartridge 10000 by depressing closure trigger 8026 for advancement. E-beam 9102. The anvil 8014 can position tissue against the tissue thickness compensator 10020 and, under various circumstances, compress the tissue thickness compensator 10020 against the support portion 10010, for example. Once the anvil 8014 has been properly positioned, the staples 10030 can be deployed, also as shown in FIG. 4 . In each case, as described above, a staple firing sled 10050, similar in many respects to sled 9126 (see FIG. shown. When the firing assembly 9090 is advanced, the sled 10050 can contact the staple drivers 10040 and lift the staple drivers 10040 upwardly within the staple cavities 10012. In at least one example, 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 . 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. In various cases, the sled 10050 can move several staples upwards simultaneously as part of a firing sequence.
如上所述并参见图5，当钉10030处于它们的未击发位置时，钉10030的钉腿10032可延伸到补偿件10020中超过支撑部分10010。在各种情况下，当钉10030处于它们的未击发位置时，钉腿10032的尖端或钉腿10032的任何其他部分可能不突出穿过组织厚度补偿件10020的顶部组织接触表面10021。在某些情况下，钉腿10032的尖端可包括能够切入和穿透组织厚度补偿件10020的锋利尖端。As noted above and referring to FIG. 5 , the staple legs 10032 of the staples 10030 can extend into the compensator 10020 beyond the support portion 10010 when the staples 10030 are in their unfired positions. In various circumstances, the tips 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. In some cases, the tips of the staple legs 10032 can comprise sharp points capable of cutting into and penetrating the tissue thickness compensator 10020 .
在各种情况下，可能优选的是防止和/或限制组织厚度补偿件和钉之间的摩擦力。现在参见图6至图8，用于与钉仓组件20200一起使用的组织厚度补偿件20220可包括至少部分地延伸穿过组织厚度补偿件20220的多个间隙孔20224。在各种情况下，钉仓组件20200可包括钉仓体20210和相对于钉仓体20210可释放地固定的组织厚度补偿件20220。仓体20210可包括例如仓平台20211和限定为穿过仓平台20211并且进入钉仓体20210的主体中的钉腔20212。钉20230例如可以可移除地定位在钉腔20212中。组织厚度补偿件20220可包括组织接触表面20221(图7)和平台接触表面20222(图6)。平台接触表面20222可以可释放地抵靠例如仓体20210的平台20211定位，并且组织接触表面20221可抵靠例如待缝合的组织T定位。间隙孔20224可延伸穿过平台接触表面20222并且进入组织厚度补偿件20220中并且可例如在组织厚度补偿件20220内包括孔、狭缝、间隙、镗孔、开口和/或清除的路径。In various circumstances, it may be preferable to prevent and/or limit frictional forces between the tissue thickness compensator and the staples. Referring now to FIGS. 6-8 , a tissue thickness compensator 20220 for use with a staple cartridge assembly 20200 can include a plurality of clearance apertures 20224 extending at least partially through the tissue thickness compensator 20220 . In various circumstances, the staple cartridge assembly 20200 can include a staple cartridge body 20210 and a tissue thickness compensator 20220 releasably secured relative to the staple cartridge body 20210 . The cartridge body 20210 can include, for example, a cartridge deck 20211 and staple cavities 20212 defined through the cartridge deck 20211 and into the body of the staple cartridge body 20210 . Staples 20230 can be removably positioned within staple cavities 20212, for example. The tissue thickness compensator 20220 can include a tissue contacting surface 20221 (FIG. 7) and a platform contacting surface 20222 (FIG. 6). Platform-contacting surface 20222 can be releasably positioned against platform 20211 , eg, cartridge body 20210 , and tissue-contacting surface 20221 can be positioned against tissue T, eg, to be stapled. Clearance holes 20224 can extend through platform contact surface 20222 and into tissue thickness compensator 20220 and can include holes, slots, gaps, bores, openings, and/or cleared paths within tissue thickness compensator 20220, for example.
主要参见图7和图8，钉20230可定位在仓体20210的钉腔20212中。每个钉20230可包括基部20231和一对钉腿20232，例如，所述钉腿可从基部20231延伸。每个钉腿20232可从基部20231的相对的两端部延伸。主要参见图7，组织厚度补偿件20220中的间隙孔20224中的一个或多个可包括平台接触表面20222中的开口。间隙孔20224的开口可与定位在钉腔20212中的对应钉腿20232对准。例如，当组织厚度补偿件20220相对于仓体20210固定时，单个钉腿20232可与单个间隙孔20224的开口对准。在某些情况下，钉腿20232可延伸到每个间隙孔20224中，使得钉20230的至少一部分嵌入例如组织厚度补偿件20220中。例如，主要参见图7，钉20230可包括第一钉腿20232a和第二钉腿20232b。此外，组织厚度补偿件20220可包括例如与第一钉腿20232a对准的第一间隙孔20224a，以及与第二钉腿20232b对准的第二间隙孔20224b。在部署钉20230之前，例如，第一钉腿20232a可部分延伸穿过第一间隙孔20224a，并且第二钉腿20232b可部分延伸穿过第二间隙孔20224b。组织厚度补偿件20220可包括例如不与钉腿20232对准的附加间隙孔20224。在某些情况下，钉仓组件20200可包括例如不与间隙孔20224对准的附加钉20230和/或钉腿20232。Referring primarily to FIGS. 7 and 8 , staples 20230 can be positioned within staple cavities 20212 of cartridge body 20210 . Each staple 20230 can include a base 20231 and a pair of staple legs 20232 that can extend from the base 20231, for example. Each staple leg 20232 can extend from opposite ends of the base 20231 . Referring primarily to FIG. 7 , one or more of the clearance apertures 20224 in the tissue thickness compensator 20220 can comprise openings in the platform contacting surface 20222 . Openings of clearance holes 20224 can be aligned with corresponding staple legs 20232 positioned in staple cavities 20212 . For example, a single staple leg 20232 can be aligned with the opening of a single clearance hole 20224 when the tissue thickness compensator 20220 is secured relative to the cartridge body 20210 . In some cases, staple legs 20232 can extend into each clearance hole 20224 such that at least a portion of staples 20230 are embedded within tissue thickness compensator 20220 , for example. For example, referring primarily to FIG. 7, a staple 20230 can include a first staple leg 20232a and a second staple leg 20232b. Additionally, the tissue thickness compensator 20220 can include, for example, a first clearance aperture 20224a aligned with the first staple leg 20232a, and a second clearance aperture 20224b aligned with the second staple leg 20232b. Prior to deploying the staples 20230, for example, the first staple leg 20232a can extend partially through the first clearance hole 20224a and the second staple leg 20232b can extend partially through the second clearance hole 20224b. The tissue thickness compensator 20220 can include, for example, additional clearance holes 20224 that are not aligned with the staple legs 20232 . In some cases, staple cartridge assembly 20200 can include, for example, additional staples 20230 and/or staple legs 20232 that are not aligned with clearance holes 20224 .
钉20230可从未击发构型(图7)运动到击发构型(图8)。每个钉20230可在未击发构型和击发构型之间运动时沿钉轴线运动。当处于未击发构型时，钉腿20232可从钉腔20212延伸并进入例如组织厚度补偿件20220中。例如，当钉20230处于未击发构型时，钉腿20232可部分嵌入组织厚度补偿件20220中。此外，例如，当钉处于未击发构型时，钉腿20232的至少一部分可与组织厚度补偿件20220的间隙孔20224对准并且/或者定位在组织厚度补偿件的间隙孔内。在其他情况下，当处于未击发构型时，钉腿20232可被整个地定位在钉腔20212内，并且可与例如定位在仓平台20211(图6)上方的间隙孔20224对准。The staples 20230 are movable from an unfired configuration (FIG. 7) to a fired configuration (FIG. 8). Each staple 20230 is movable along a staple axis as it moves between an unfired configuration and a fired configuration. Staple legs 20232 can extend from staple cavities 20212 and into, for example, tissue thickness compensator 20220 when in the unfired configuration. For example, the staple legs 20232 can be partially embedded in the tissue thickness compensator 20220 when the staples 20230 are in the unfired configuration. Additionally, for example, at least a portion of staple legs 20232 can be aligned with and/or positioned within clearance apertures 20224 of tissue thickness compensator 20220 when the staples are in the unfired configuration. In other cases, staple legs 20232 can be positioned entirely within staple cavities 20212 and can be aligned with, for example, clearance holes 20224 positioned above cartridge deck 20211 ( FIG. 6 ) when in the unfired configuration.
在击发行程期间，钉20230可从未击发构型(图7)运动到击发构型(图8)，如本文所述。钉驱动器20240可被定位在每个钉腔20212内。每个钉腔20212内的钉驱动器20240可朝仓平台20211(图6)推动，例如，以将钉20230驱动到组织T中并且朝砧座20260驱动(图8)，该砧座可在许多方面类似于本文所述的其他砧座，例如砧座8014(图1)。在每个钉20230从未击发构型运动到击发构型时，钉腿20232可运动穿过组织厚度补偿件20220中的间隙孔20224。间隙孔20224可具有组织厚度补偿件20220内的预定轨线。例如，间隙孔20224可沿垂直于并且/或者基本上垂直于组织厚度补偿件20220的组织接触表面20221(图7)和/或平台接触表面20222(图6)的轴线延伸。在其他情况下，间隙孔20224可沿相对于例如组织厚度补偿件20220的组织接触表面20221和/或平台接触表面20222以斜角取向的轴线延伸。在某些情况下，一组间隙孔20224可为平行的。在一些情况下，例如，组织厚度补偿件20220内的所有间隙孔20224可为平行的。间隙孔20224可包括部分弯曲的轨线和/或部分线性的轨线。间隙孔20224的其他特性和特征在2013年3月27日提交的名称为“FASTENER CARTRIDGEASSEMBLY”的美国专利申请13/851,693中更详细地描述，该专利的全部公开内容以引用方式并入本文。用于将组织厚度补偿件修改为包括间隙孔诸如间隙孔20224的方法和技术在下文中更详细地描述。During the firing stroke, the staples 20230 can be moved from an unfired configuration (FIG. 7) to a fired configuration (FIG. 8), as described herein. A staple driver 20240 can be positioned within each staple cavity 20212. The staple drivers 20240 within each staple cavity 20212 can be pushed toward the cartridge deck 20211 ( FIG. 6 ), for example, to drive the staples 20230 into the tissue T and toward the anvil 20260 ( FIG. 8 ), which can be used in a number of ways. Similar to other anvils described herein, such as anvil 8014 (FIG. 1). As each staple 20230 is moved from the unfired configuration to the fired configuration, the staple legs 20232 are movable through the clearance holes 20224 in the tissue thickness compensator 20220. Clearance aperture 20224 can have a predetermined trajectory within tissue thickness compensator 20220 . For example, clearance aperture 20224 can extend along an axis perpendicular and/or substantially perpendicular to tissue contacting surface 20221 ( FIG. 7 ) and/or platform contacting surface 20222 ( FIG. 6 ) of tissue thickness compensator 20220 . In other cases, clearance aperture 20224 may extend along an axis oriented at an oblique angle relative to, for example, tissue contacting surface 20221 and/or platform contacting surface 20222 of tissue thickness compensator 20220 . In some cases, a set of clearance holes 20224 may be parallel. In some cases, for example, all of the clearance holes 20224 within the tissue thickness compensator 20220 can be parallel. Clearance aperture 20224 may include a partially curved trajectory and/or a partially linear trajectory. Other features and characteristics of the interstitial aperture 20224 are described in more detail in US Patent Application 13/851,693, filed March 27, 2013, entitled "FASTENER CARTRIDGEASSEMBLY," the entire disclosure of which is incorporated herein by reference. Methods and techniques for modifying a tissue thickness compensator to include clearance apertures such as clearance aperture 20224 are described in more detail below.
现在参见图9至图12，在许多方面类似于外科器械8010的外科器械的端部执行器22090例如可包括具有紧固件仓组件22000的第一钳口和具有砧座10060的第二钳口。第一钳口可包括钉仓通道10070，该钉仓通道可被构造成能够可移除地接收仓组件22000。另选地，钉仓通道10070和仓组件22000可包括整体单元。在各种情况下，砧座10060可在打开位置和闭合位置(图9至图12)之间运动。在砧座10060的打开位置中，例如，砧座10060可定位在患者的组织T(图10至图12)的第一侧上，并且仓组件22000可定位在组织T的第二或相对侧上。当砧座10060运动到其闭合位置中时，砧座10060可抵靠仓组件22000压缩组织T。另选地，包括仓组件22000的第一钳口可相对于砧座10060运动。在许多方面类似于击发组件9090(图3)的击发构件10052可从仓组件22000的近侧端部22001朝仓组件22000的远侧端部22002朝远侧推进以在击发构件10052从近侧端部22001朝仓组件22000的远侧端部22002推进时射出紧固件，诸如可移除地储存在仓组件22000的仓体22010中的钉22030。Referring now to FIGS. 9-12 , an end effector 22090 of a surgical instrument similar in many respects to surgical instrument 8010 can include, for example, a first jaw having a fastener cartridge assembly 22000 and a second jaw having an anvil 10060 . The first jaw can include a staple cartridge channel 10070 that can be configured to removably receive the cartridge assembly 22000 . Alternatively, staple cartridge channel 10070 and cartridge assembly 22000 may comprise an integral unit. In various instances, the anvil 10060 is movable between an open position and a closed position ( FIGS. 9-12 ). In the open position of the anvil 10060, for example, the anvil 10060 can be positioned on a first side of the patient's tissue T ( FIGS. 10-12 ), and the cartridge assembly 22000 can be positioned on a second or opposite side of the tissue T. . The anvil 10060 can compress the tissue T against the cartridge assembly 22000 when the anvil 10060 is moved into its closed position. Alternatively, the first jaw comprising the cartridge assembly 22000 is movable relative to the anvil 10060 . A firing member 10052 similar in many respects to the firing assembly 9090 ( FIG. 3 ) can be advanced distally from the proximal end 22001 of the cartridge assembly 22000 toward the distal end 22002 of the cartridge assembly 22000 to activate the firing member 10052 from the proximal end. Advancement of portion 22001 toward distal end 22002 of cartridge assembly 22000 ejects fasteners, such as staples 22030 removably stored in cartridge body 22010 of cartridge assembly 22000 .
对上文进行进一步描述，钉22030可由钉驱动器10040支撑，该钉驱动器可动地定位在限定在仓体22010中的钉腔22012内。此外，击发构件10052可被构造成能够在击发构件10052从近侧端部22001朝远侧端部22002运动时在仓体22010内朝远侧推进钉击发滑动件10050。在此类情况下，钉击发滑动件10050可被构造成能够朝砧座10060提升钉驱动器10040以及支撑在其上的钉22030。实质上，对上文进行进一步描述，钉驱动器10040可使钉22030从未击发位置(图10)运动到击发位置(图11和图12)，其中钉22030可接触砧座10060并且在未变形构型(图10)和变形构型(图11和图12)之间变形。砧座10060可包括成形凹坑10062，该成形凹坑可被构造成能够接收钉22030并且使钉变形。钉22030可与例如钉10030和/或本文所公开的任何其他钉相同或相似，并且因此，钉22030在本文中未更详细地描述。然而，读者将注意到，钉22030例如在其未变形构型和/或其变形构型中包括任何合适的形状和/或合适的尺寸，诸如宽度和/或高度。例如，在某些情况下，当钉22030处于其未击发位置时，钉22030可包括不延伸到仓体22010的平台表面22011之上的高度，而在其他情况下，当钉22030处于其未击发位置时，钉22030可包括其中钉22030的腿从平台表面22011向上延伸的高度，使得钉22030的腿至少部分地嵌入仓组件22000的组织厚度补偿件22010中。Further to the above, staples 22030 can be supported by staple drivers 10040 movably positioned within staple cavities 22012 defined in cartridge body 22010 . Additionally, the firing member 10052 can be configured to be capable of advancing the staple firing sled 10050 distally within the cartridge body 22010 as the firing member 10052 is moved from the proximal end 22001 toward the distal end 22002 . In such cases, the staple firing sled 10050 can be configured to be capable of lifting the staple drivers 10040 and the staples 22030 supported thereon towards the anvil 10060. In essence, further to the above, the staple drivers 10040 can move the staples 22030 from an unfired position (FIG. 10) to a fired position (FIGS. 11 and 12), wherein the staples 22030 can contact the anvil 10060 and be in the undeformed configuration. deformed between the deformed configuration (Fig. 10) and the deformed configuration (Fig. 11 and Fig. 12). Anvil 10060 can include forming pockets 10062 that can be configured to receive and deform staples 22030. Staples 22030 can be the same or similar to, for example, staples 10030 and/or any other staples disclosed herein, and thus, staples 22030 are not described in greater detail herein. However, the reader will note that the staples 22030 comprise any suitable shape and/or suitable dimensions, such as width and/or height, eg, in their undeformed configuration and/or their deformed configuration. For example, in some cases, the staples 22030 may include a height that does not extend above the deck surface 22011 of the cartridge body 22010 when the staples 22030 are in their unfired position, while in other circumstances, the staples 22030 may include heights that do not extend above the deck surface 22011 of the cartridge body 22010 when the staples 22030 are in their unfired position. When in position, the staples 22030 can comprise a height wherein the legs of the staples 22030 extend upwardly from the deck surface 22011 such that the legs of the staples 22030 are at least partially embedded in the tissue thickness compensator 22010 of the cartridge assembly 22000.
继续参考图9至图12中所示的实施方案，对上文进行进一步描述，仓组件22000可包括仓体22010和组织厚度补偿件22020。在各种情况下，仓体22010可例如在许多方面类似于支撑部分10010，因此，为了简洁起见，此类方面中的许多在本文中不重复。此外，组织厚度补偿件22020可例如在许多方面类似于组织厚度补偿件10020。对上文进行进一步描述，击发构件10052可包括切割部分10053，该切割部分可被构造成能够在击发构件10052朝远侧推进时横切定位在砧座10060和组织厚度补偿件22020之间的组织。因此，在各种情况下，击发构件10052可被构造成能够同时击发钉22030以缝合组织T并且切割组织T。在某些情况下，击发过程可至少部分地引起切割过程。换句话讲，切割过程可滞后击发过程。在此类情况下，组织T的一部分可被缝合，然后切入。Continuing to further describe the above with reference to the embodiments shown in FIGS. 9-12 , the cartridge assembly 22000 can include a cartridge body 22010 and a tissue thickness compensator 22020 . In various cases, the cartridge body 22010 may, for example, be similar to the support portion 10010 in many respects, and thus, for the sake of brevity, many of such aspects are not repeated herein. Furthermore, tissue thickness compensator 22020 can be similar to tissue thickness compensator 10020, for example, in many respects. Further to the above, the firing member 10052 can include a cutting portion 10053 that can be configured to transect tissue positioned between the anvil 10060 and the tissue thickness compensator 22020 when the firing member 10052 is advanced distally. . Accordingly, firing member 10052 can be configured to simultaneously fire staples 22030 to staple tissue T and cut tissue T in various circumstances. In some cases, the firing process may at least partially cause the cutting process. In other words, the cutting process may lag the firing process. In such cases, a portion of tissue T may be sutured and then incised.
如图9至图12所示，仓体22010可包括仓刀狭槽22015，该仓刀狭槽可被构造成能够在击发构件10052朝远侧推进时接收击发构件10052的一部分。对上文进行进一步描述，砧座10060可包括砧座刀狭槽10065，该砧座刀狭槽可被构造成能够在击发构件10052朝远侧推进时接收击发构件10052的一部分。在各种情况下，组织厚度补偿件22020可包括组织厚度补偿件刀狭槽22025，该组织厚度补偿件刀狭槽可与砧座刀狭槽10065和仓刀狭槽22015对准，使得击发构件10052可同时通过仓刀狭槽22015、砧座刀狭槽10065和组织厚度补偿件刀狭槽22025。在各种情况下，砧座刀狭槽10065可在组织厚度补偿件刀狭槽22025上方延伸，使得击发构件10052的切割部分10053可同时通过仓刀狭槽22015、砧座刀狭槽10065和组织厚度补偿件刀狭槽22025。组织厚度补偿件刀狭槽22025可限定切割部分10053的组织厚度补偿件刀路径，其中组织厚度补偿件刀路径可平行于砧座刀路径和仓刀路径。在各种情况下，组织厚度补偿件刀路径可为纵向的，而在某些情况下，组织厚度补偿件刀路径可为弯曲的。对上文进行进一步描述，弯曲的端部执行器和弯曲的紧固件仓在美国专利申请公布2008/0169329中有所公开。2007年1月11日提交的名称为“CURVED END EFFECTOR FOR ASURGICAL STAPLING DEVICE”的美国专利申请序列号11/652,164(现为美国专利申请公布2008/0169329)的全部公开内容据此以引用方式并入本文中。在此类情况下，组织厚度补偿件可为弯曲的。在至少一个此类实施方案中，组织厚度补偿件可为弯曲的，以匹配紧固件仓的仓体的曲率。用于将组织厚度补偿件修改为包括刀狭槽诸如刀狭槽22025的方法和技术在下文中有所描述。As shown in FIGS. 9-12 , the cartridge body 22010 can include a cartridge knife slot 22015 that can be configured to receive a portion of the firing member 10052 as the firing member 10052 is advanced distally. Further to the above, the anvil 10060 can include an anvil knife slot 10065 that can be configured to receive a portion of the firing member 10052 as the firing member 10052 is advanced distally. In various instances, the tissue thickness compensator 22020 can include a tissue thickness compensator knife slot 22025 that can be aligned with the anvil knife slot 10065 and the cartridge knife slot 22015 such that the firing member 10052 can pass through bin knife slot 22015, anvil knife slot 10065 and tissue thickness compensator knife slot 22025 simultaneously. In various instances, the anvil knife slot 10065 can extend over the tissue thickness compensator knife slot 22025 such that the cutting portion 10053 of the firing member 10052 can pass through the cartridge knife slot 22015, the anvil knife slot 10065, and the tissue simultaneously. Thickness compensator knife slot 22025. The tissue thickness compensator knife slot 22025 can define the tissue thickness compensator knife path of the cutting portion 10053, wherein the tissue thickness compensator knife path can be parallel to the anvil knife path and the cartridge knife path. In various cases, the tissue thickness compensator knife path can be longitudinal, and in some cases, the tissue thickness compensator knife path can be curved. Further to the above, curved end effectors and curved fastener cartridges are disclosed in US Patent Application Publication 2008/0169329. The entire disclosure of U.S. Patent Application Serial No. 11/652,164, filed January 11, 2007, entitled "CURVED END EFFECTOR FOR ASURGICAL STAPLING DEVICE," now U.S. Patent Application Publication 2008/0169329, is hereby incorporated by reference In this article. In such cases, the tissue thickness compensator may be curved. In at least one such embodiment, the tissue thickness compensator can be curved to match the curvature of the cartridge body of the fastener cartridge. Methods and techniques for modifying a tissue thickness compensator to include knife slots such as knife slot 22025 are described below.
对上文进行进一步描述，主要参见图9，组织厚度补偿件刀狭槽22025可在第一缝合部分22021a和第二缝合部分22021b之间延伸，该第一缝合部分可由第一组钉22030缝合，该第二缝合部分可由第二组钉22030缝合。刀狭槽22025可将第一缝合部分22021a可释放地连接到第二缝合部分22021b。在使用中，如图9所示，切割部分10053可朝远侧推进穿过刀狭槽22025以横切刀狭槽22025并且将第一缝合部分22021a与第二缝合部分22021b分离。在某些情况下，刀狭槽22025可包括多个连接器或桥接件22026，其可在被切割部分10053横切之前连接第一缝合部分22021a和第二缝合部分22021b。在各种情况下，至少在组织厚度补偿件22020处于未压缩状态时，连接器22026可具有与第一缝合部分22021a和/或第二缝合部分22021b相同的厚度。在至少一种这样的情况下，连接器22026、第一缝合部分22021a和/或第二缝合部分22021b可由例如平坦的或至少基本上平坦的材料片整体且一体地形成。在各种其他情况下，第一缝合部分22021a可包括第一厚度，第二缝合部分22021b可包括第二厚度，并且连接器22026可包括第三厚度，其中第一厚度、第二厚度和第三厚度中的一者或多者可不同于其他厚度。Referring further to the above, referring primarily to FIG. 9 , the tissue thickness compensator knife slot 22025 can extend between a first stitched portion 22021 a and a second stitched portion 22021 b, which can be stitched by a first set of staples 22030 , The second stitched portion can be stitched by a second set of staples 22030 . The knife slot 22025 can releasably connect the first stitched portion 22021a to the second stitched portion 22021b. In use, as shown in FIG. 9 , the cutting portion 10053 can be advanced distally through the knife slot 22025 to transect the knife slot 22025 and separate the first stapling portion 22021a from the second stapling portion 22021b. In some cases, the knife slot 22025 can include a plurality of connectors or bridges 22026 that can connect the first stitched portion 22021a and the second stitched portion 22021b prior to being transected by the cut portion 10053 . In various circumstances, the connector 22026 can have the same thickness as the first stitched portion 22021a and/or the second stitched portion 22021b at least when the tissue thickness compensator 22020 is in an uncompressed state. In at least one such instance, the connector 22026, the first stitched portion 22021a, and/or the second stitched portion 22021b can be unitarily and integrally formed from, for example, a planar or at least substantially planar sheet of material. In various other cases, the first stitched portion 22021a can include a first thickness, the second stitched portion 22021b can include a second thickness, and the connector 22026 can include a third thickness, wherein the first thickness, the second thickness, and the third thickness One or more of the thicknesses may be different from the other thicknesses.
刀狭槽22025还可包括例如限定于其中的孔，诸如孔22024。例如，孔22024可为细长的并且可沿刀狭槽22025纵向延伸。在各种其他情况下，刀狭槽22025中的孔可包括任何合适的布置。在某些情况下，孔22024可包括定位在连接器22026中间的穿孔，其可利用例如激光切割操作来形成。在一些情况下，孔22024可从材料片切割以形成组织厚度补偿件22020，使得孔22024和连接器22026例如以交替布置的方式布置。在其他情况下，组织厚度补偿件22020可模制成孔22024已形成于其中。在各种情况下，孔22024中的一个或多个可包括例如通孔。在各种情况下，孔22024中的一个或多个可包括例如间隙孔。在某些情况下，孔22024中的一个或多个可不包括通孔，并且相反可具有例如刀狭槽22025的减小厚度。用于将组织厚度补偿件修改为包括孔诸如孔22024的方法和技术在下文中有所描述。Knife slot 22025 may also include a hole, such as hole 22024, defined therein, for example. For example, the hole 22024 can be elongated and can extend longitudinally along the knife slot 22025 . In various other cases, the holes in knife slot 22025 can comprise any suitable arrangement. In some cases, aperture 22024 may comprise a perforation positioned in the middle of connector 22026, which may be formed using, for example, a laser cutting operation. In some cases, holes 22024 can be cut from a sheet of material to form tissue thickness compensator 22020 such that holes 22024 and connectors 22026 are arranged, for example, in an alternating arrangement. In other cases, the tissue thickness compensator 22020 can be molded with holes 22024 already formed therein. In various cases, one or more of holes 22024 may comprise, for example, through holes. In various cases, one or more of apertures 22024 may comprise, for example, interstitial apertures. In some cases, one or more of holes 22024 may not include a through hole, and instead may have a reduced thickness, such as knife slot 22025 . Methods and techniques for modifying a tissue thickness compensator to include apertures such as aperture 22024 are described below.
对上文进行进一步描述，再次参见图9至图11，当砧座10060处于打开位置时，患者组织可被定位在端部执行器22090的砧座10060和仓组件22000的组织厚度补偿件22020之间。当砧座10060运动到闭合位置中时，砧座10060的底部表面或组织接触表面10063可接触组织T并且朝仓体22010的平台表面22011推动组织T。组织T可接触组织厚度补偿件22020的顶部表面或组织接触表面22021，其中当砧座10060运动到其闭合位置中时，砧座10060可抵靠组织厚度补偿件22020按压组织T，并且对上文进行进一步描述，抵靠仓体22010的平台表面22011压缩组织厚度补偿件22020。在各种情况下，组织厚度补偿件22020可包括底部表面22029，该底部表面可邻接平台表面22011。在一些情况下，在组织厚度补偿件22020抵靠仓体22010被压缩之前，间隙可存在于底部表面22029和平台表面22011之间。在此类情况下，组织厚度补偿件22020可在抵靠仓体22010被压缩之前首先朝仓体平移。当组织厚度补偿件22020抵靠仓体22010被压缩时，在各种情况下，组织厚度补偿件22020的第一缝合部分22021a和/或第二缝合部分22021b可横向运动。例如，第一缝合部分22021a和/或第二缝合部分22021b可横向移动远离仓刀狭槽22015。在各种情况下，连接器22026可被构造成能够抑制第一缝合部分22021a和第二缝合部分22021b之间的此类横向运动。在各种情况下，主要参见图11，连接器22026可被构造成能够拉伸以在砧座10060闭合时允许第一缝合部分22021a和第二缝合部分22021b之间的一些相对横向运动。在砧座10060被重新打开的情况下，连接器22026可被构造成能够弹性地返回，或至少基本上返回到其未拉伸构型，并且作为结果，将第一缝合部分22021a和第二缝合部分22021b朝示于图10中的其初始位置横向拉回。此外，当砧座10060运动到其闭合位置中时，砧座10060可压缩组织T。在此类情况下，组织T可至少部分地流动到孔22024中。Referring further to the above, referring again to FIGS. 9-11 , when the anvil 10060 is in the open position, patient tissue can be positioned between the anvil 10060 of the end effector 22090 and the tissue thickness compensator 22020 of the cartridge assembly 22000 between. When the anvil 10060 is moved into the closed position, the bottom surface or tissue contacting surface 10063 of the anvil 10060 can contact the tissue T and push the tissue T towards the deck surface 22011 of the cartridge body 22010 . Tissue T can contact the top surface or tissue contacting surface 22021 of the tissue thickness compensator 22020, wherein when the anvil 10060 is moved into its closed position, the anvil 10060 can press the tissue T against the tissue thickness compensator 22020, and to the above To describe further, the tissue thickness compensator 22020 is compressed against the deck surface 22011 of the cartridge body 22010 . In various circumstances, tissue thickness compensator 22020 can include a bottom surface 22029 that can abut deck surface 22011 . In some cases, a gap may exist between bottom surface 22029 and deck surface 22011 before tissue thickness compensator 22020 is compressed against cartridge body 22010 . In such cases, the tissue thickness compensator 22020 can first translate toward the cartridge body 22010 before being compressed against the cartridge body. When the tissue thickness compensator 22020 is compressed against the cartridge body 22010, the first stitched portion 22021a and/or the second stitched portion 22021b of the tissue thickness compensator 22020 can move laterally in various circumstances. For example, the first stitched portion 22021a and/or the second stitched portion 22021b can move laterally away from the magazine knife slot 22015 . In various circumstances, the connector 22026 can be configured to inhibit such lateral movement between the first stitched portion 22021a and the second stitched portion 22021b. In various cases, referring primarily to FIG. 11 , the connector 22026 can be configured to be stretchable to allow some relative lateral movement between the first and second stitched portions 22021a, 22021b when the anvil 10060 is closed. Under the situation that anvil block 10060 is reopened, connector 22026 can be configured to elastically return, or at least return substantially to its unstretched configuration, and as a result, the first sutured portion 22021a and the second sutured portion 22021a Portion 22021b is pulled back laterally towards its initial position shown in FIG. 10 . Additionally, the anvil 10060 can compress the tissue T when the anvil 10060 is moved into its closed position. Under such circumstances, tissue T can at least partially flow into aperture 22024 .
在查看图10至图12时，读者将认识到，组织厚度补偿件22020的刀狭槽22025沿其纵向长度包括比第一缝合部分22021a和/或第二缝合部分22021b少的材料。换句话讲，穿过第一缝合部分22021a和/或第二缝合部分22021b的纵向横截面将横切第一量的材料，而穿过刀狭槽22025的纵向横截面将横切比第一量的材料少的第二量的材料。Upon reviewing FIGS. 10-12 , the reader will appreciate that the knife slot 22025 of the tissue thickness compensator 22020 includes less material along its longitudinal length than the first stitched portion 22021a and/or the second stitched portion 22021b. In other words, a longitudinal cross-section through the first seam portion 22021a and/or the second seam portion 22021b will traverse the first amount of material, while a longitudinal cross-section through the knife slot 22025 will cross-cut more than the first amount of material. The amount of material is less than the second amount of material.
一旦砧座10060已被适当地定位，对上文进行进一步描述，击发构件10052可朝远侧推进以击发钉，如图11所示，并且切入组织T和连接器22026，如图12所示。此外，组织厚度补偿件切入力、组织切入力、组织厚度补偿件阻力、和/或组织阻力可使击发构件10052的切割部分10053钝化。钝刀可能不能够例如根据优选的方式横切组织T和/或组织厚度补偿件22020。主要参见图12，切割部分10053可包括例如第一刀刃区10053a、第二刀刃区10053b和/或第三刀刃区10053c，其中第一刀刃区10053a竖直定位在第二刀刃区10053b上方，并且其中第二刀刃区10053b竖直定位在例如第三刀刃区10053c上方。切割部分10053可包括任何合适数目和/或位置的刀刃区，其中出于讨论的目的已选择图12中所示的刀刃区。对上文进行进一步描述，第一刀刃区10053a可被构造成能够横切组织T，而第二刀刃区10053b可被构造成能够横切组织厚度补偿件22020。作为结果，第一刀刃区10053a可经受上述组织切入力和/或组织阻力。此类力可以第一速率磨损或钝化第一刀刃区10053a。第二刀刃区10053b可经受上述组织厚度补偿件切入力和/或组织厚度补偿件阻力。此类力可以第二速率磨损或钝化第二刀刃区10053b。在各种情况下，第二速率可不同于第一速率。Once the anvil 10060 has been properly positioned, further to the above, the firing member 10052 can be advanced distally to fire the staples, as shown in FIG. 11 , and cut into the tissue T and connector 22026, as shown in FIG. 12 . Additionally, the tissue thickness compensator incision force, tissue incision force, tissue thickness compensator resistance, and/or tissue resistance can blunt the cutting portion 10053 of the firing member 10052 . A dull knife may not be able to transect tissue T and/or tissue thickness compensator 22020, eg, according to the preferred manner. Referring primarily to FIG. 12, the cutting portion 10053 may include, for example, a first edge region 10053a, a second edge region 10053b, and/or a third edge region 10053c, wherein the first edge region 10053a is positioned vertically above the second edge region 10053b, and wherein The second edge region 10053b is positioned vertically above, for example, the third edge region 10053c. Cutting portion 10053 may include any suitable number and/or location of edge regions, with the edge regions shown in FIG. 12 having been selected for purposes of discussion. Further to the above, the first blade region 10053a can be configured to transect the tissue T, and the second blade region 10053b can be configured to transect the tissue thickness compensator 22020 . As a result, the first edge region 10053a can withstand the aforementioned tissue penetration forces and/or tissue resistance. Such forces can wear or dull the first edge region 10053a at a first rate. The second cutting edge region 10053b can withstand the aforementioned tissue thickness compensator penetration force and/or tissue thickness compensator resistance. Such forces may wear or dull the second edge region 10053b at the second rate. In various cases, the second rate may be different than the first rate.
现在转向图13和图14，紧固件仓22400可包括组织厚度补偿件22420，该组织厚度补偿件可包括由刀狭槽22425连接的第一缝合部分22421a和第二缝合部分22421b。刀狭槽22425可包括成角度的纵向连接器22426。成角度的纵向连接器22426可在刀狭槽22425的近侧端部22401和刀狭槽22425的远侧端部22402之间延伸。在一些情况下，成角度的纵向连接器22426可延伸刀狭槽22425的整个长度，而在其他情况下，成角度的纵向连接器22426可延伸小于刀狭槽22425的长度。成角度的纵向连接器22426可在组织厚度补偿件22420的顶部表面22428和组织厚度补偿件22420的底部表面22429之间延伸。在一些情况下，成角度的纵向连接器22426可延伸顶部表面22428和底部表面22429之间的整个距离，而在其他情况下，成角度的纵向连接器22426可延伸小于顶部表面22428和底部表面22429之间的距离。在各种情况下，纵向连接器22426的近侧端部可从组织厚度补偿件的顶部表面22428延伸，而纵向连接器22426的远侧端部可从底部表面22429延伸。另选地，纵向连接器22426的远侧端部可从组织厚度补偿件的顶部表面22428延伸，而纵向连接器22426的近侧端部可从底部表面22429延伸。在各种情况下，纵向连接器22426可包括薄的桥接件(即，小于组织厚度补偿件22420的整个厚度)或一系列薄的桥接件，该桥接件可例如将第一缝合部分22421a接合到第二缝合部分22421b，该第一缝合部分可由第一组钉22030缝合，该第二缝合部分可由第二组钉22030缝合。这些薄的、成角度的桥接件和/或纵向连接器22426可在第二刀刃区10053b上分布磨损，而不是将其集中在一个点上。在各种情况下，作为结果，例如，出现在第二刀刃区10053b上的磨损可等于或接近等于出现在第一刀刃区10053a处的磨损。Turning now to FIGS. 13 and 14 , the fastener cartridge 22400 can include a tissue thickness compensator 22420 that can include a first stitched portion 22421 a and a second stitched portion 22421 b joined by a knife slot 22425 . The knife slot 22425 can include an angled longitudinal connector 22426. The angled longitudinal connector 22426 can extend between the proximal end 22401 of the knife slot 22425 and the distal end 22402 of the knife slot 22425 . In some cases, the angled longitudinal connector 22426 can extend the entire length of the knife slot 22425 , while in other cases, the angled longitudinal connector 22426 can extend less than the length of the knife slot 22425 . The angled longitudinal connector 22426 can extend between the top surface 22428 of the tissue thickness compensator 22420 and the bottom surface 22429 of the tissue thickness compensator 22420 . In some cases, the angled longitudinal connector 22426 can extend the entire distance between the top surface 22428 and the bottom surface 22429, while in other cases, the angled longitudinal connector 22426 can extend less than the top surface 22428 and the bottom surface 22429 the distance between. In various instances, the proximal end of the longitudinal connector 22426 can extend from the top surface 22428 of the tissue thickness compensator, while the distal end of the longitudinal connector 22426 can extend from the bottom surface 22429 . Alternatively, the distal end of the longitudinal connector 22426 can extend from the top surface 22428 of the tissue thickness compensator, while the proximal end of the longitudinal connector 22426 can extend from the bottom surface 22429. In various instances, longitudinal connector 22426 can comprise a thin bridge (i.e., less than the entire thickness of tissue thickness compensator 22420) or a series of thin bridges that can, for example, join first suture portion 22421a to The second stitched portion 22421b, the first stitched portion can be stitched by the first set of staples 22030, the second stitched portion can be stitched by the second set of staples 22030. These thin, angled bridges and/or longitudinal connectors 22426 can distribute wear across the second edge region 10053b rather than concentrating it at one point. In each case, as a result, for example, the wear occurring on the second edge region 10053b may be equal or nearly equal to the wear occurring at the first edge region 10053a.
现在参见图15至图17，示例性组织厚度补偿件组件1000可包括第一层1002和可附接到第一层1002的第二层1004。组织厚度补偿件组件1000可用外科器械，诸如外科器械8010(图1)来使用。另外，组织厚度补偿件组件1000可以与端部执行器22090的仓组件22000的组织厚度补偿件22020类似的方式来使用并且可替代组织厚度补偿件22020(图9)。例如，组织厚度补偿件组件1000的第二层1004可包括可以与第一缝合部分22021a类似的方式定位在仓刀狭槽22015的第一侧上的平台表面22011上的第一部分1006，以及可以与第二缝合部分22021b类似的方式定位在仓刀狭槽22015的与第一侧相对的第二侧上的平台表面22011上的第二部分1008(图9至图11)。在各种情况下，第二层1004的第一部分1006和第二部分1008可间隔开并且可在其间包括间隙1010，该间隙可包括用于击发构件10052的切割部分10053的刀路径并且可在组织厚度补偿件组件1000组装有仓端部执行器22090时至少部分地在仓刀狭槽22015上方延伸。在某些情况下，第一层1002可被构造成能够联接第一部分1006和第二部分1008并且至少部分地在间隙1010上方延伸，例如如图17所示。Referring now to FIGS. 15-17 , an exemplary tissue thickness compensator assembly 1000 can include a first layer 1002 and a second layer 1004 attachable to the first layer 1002 . Tissue thickness compensator assembly 1000 may be used with a surgical instrument, such as surgical instrument 8010 (FIG. 1). In addition, the tissue thickness compensator assembly 1000 can be used in a similar manner to and in place of the tissue thickness compensator 22020 of the cartridge assembly 22000 of the end effector 22090 (FIG. 9). For example, the second layer 1004 of the tissue thickness compensator assembly 1000 can include a first portion 1006 that can be positioned on the deck surface 22011 on a first side of the knife slot 22015 in a similar manner as the first stitched portion 22021a, and can be aligned with The second stitched portion 22021b is positioned in a similar manner to the second portion 1008 on the deck surface 22011 on the second side of the knife slot 22015 opposite the first side ( FIGS. 9-11 ). In various circumstances, the first portion 1006 and the second portion 1008 of the second layer 1004 can be spaced apart and can include a gap 1010 therebetween, which can include a knife path for the cutting portion 10053 of the firing member 10052 and can create a gap in the tissue. The thickness compensator assembly 1000 extends at least partially over the cartridge knife slot 22015 when assembled with the cartridge end effector 22090 . In some cases, first layer 1002 can be configured to couple first portion 1006 and second portion 1008 and extend at least partially over gap 1010 , such as shown in FIG. 17 .
在使用中，组织T可被捕获在砧座10060和第一层1002的组织接触表面1012之间。在击发构件10052被推进时，第一组钉20030可被部署以缝合第一部分1006并且第二组钉可被部署以缝合第二部分1008。第一组钉和第二组钉可被构造成能够分别穿透第二层1004的第一平台接触表面1007和第二平台接触表面1009，然后穿透第一层的组织接触表面1012，然后穿透所捕获的组织T以接触砧座10060的凹坑10062。此外，击发构件10052的推进可致使切割部分10053朝远侧推进穿过组织厚度补偿件组件1000的间隙1010。切割部分10053可横切第一层1002，同时推进穿过间隙1010，从而将第二层1004的第一部分1006和第二部分1008分离。In use, tissue T may be captured between the anvil 10060 and the tissue contacting surface 1012 of the first layer 1002 . As the firing member 10052 is advanced, the first set of staples 20030 can be deployed to staple the first portion 1006 and the second set of staples can be deployed to staple the second portion 1008 . The first set of staples and the second set of staples can be configured to penetrate the first platform contacting surface 1007 and the second platform contacting surface 1009 of the second layer 1004 respectively, then penetrate the tissue contacting surface 1012 of the first layer, and then penetrate The captured tissue T is penetrated to contact the dimple 10062 of the anvil 10060. Additionally, advancement of the firing member 10052 can cause the cutting portion 10053 to be advanced distally through the gap 1010 of the tissue thickness compensator assembly 1000 . The cutting portion 10053 may transect the first layer 1002 while advancing through the gap 1010 thereby separating the first portion 1006 and the second portion 1008 of the second layer 1004 .
再次参见图17，组织厚度补偿件组件1000的第一层1002可包括第一高度H1，第二层1004的第一部分1006可包括第二高度H2，并且第二层1004的第二部分1008可包括第三高度H3。在某些情况下，如图17所示，第二高度H2和第三高度H3可为相同或基本上相同的。在其他情况下，第二高度H2可不同于第三高度H3。在某些情况下，第一高度H1可小于第二高度H2和/或第三高度H3，如图17所示。组织厚度补偿件组件1000的第一层1002可包括第一密度，第二层1004的第一部分1006可包括第二密度，并且第二层1004的第二部分1008可包括第三密度。在某些情况下，如图17所示，第二密度和第三密度可为相同或基本上相同的。在其他情况下，第二密度可不同于第三密度并且/或者不同于第一层1002的第一密度。第一部分1006和第二部分1008的材料组成可为相同或至少基本上相同的。在其他情况下，第一部分1006和第二部分1008的材料组成可彼此不同并且/或者可不同于第一层1002的材料组成。Referring again to FIG. 17 , the first layer 1002 of the tissue thickness compensator assembly 1000 can include a first height H1, the first portion 1006 of the second layer 1004 can include a second height H2, and the second portion 1008 of the second layer 1004 can include Third height H3. In some cases, as shown in FIG. 17, second height H2 and third height H3 may be the same or substantially the same. In other cases, the second height H2 may be different from the third height H3. In some cases, the first height H1 may be smaller than the second height H2 and/or the third height H3, as shown in FIG. 17 . The first layer 1002 of the tissue thickness compensator assembly 1000 can include a first density, the first portion 1006 of the second layer 1004 can include a second density, and the second portion 1008 of the second layer 1004 can include a third density. In some cases, as shown in FIG. 17, the second density and the third density may be the same or substantially the same. In other cases, the second density may be different than the third density and/or different than the first density of the first layer 1002 . The material composition of the first portion 1006 and the second portion 1008 may be the same or at least substantially the same. In other cases, the material composition of first portion 1006 and second portion 1008 may differ from each other and/or may differ from the material composition of first layer 1002 .
如上所述，重复使用切割部分10053来切割组织T和组织厚度补偿件材料可钝化切割部分10053。为了减慢钝化过程，可能需要减少由切割部分10053切割的组织厚度补偿件材料。附加的益处可为在击发行程期间朝远侧推进击发构件10052所需的力减小。为了减小切割部分10053的钝化，第一层1002可至少部分地包括例如薄膜。在此类情况下，第一高度H1可显著小于第二高度H2和第三高度H3，如图17所示。在某些情况下，第一层1002可具有穿过其中的均匀或基本上均匀的高度，如图17所示。在其他情况下，第一层1002的间隙桥接部分1014可至少部分地在间隙1010上方延伸并且可比第一层1002的剩余部分薄。切割部分10053可横切第一层1002的间隙桥接部分1014同时推进穿过第二层1004的第一部分1006和第二部分1008之间的间隙1010，这可减小切割部分10053所经受的阻力并且/或者减慢切割部分10053的钝化。在任何情况下，第一层1002可被构造成能够在被横切之前维持与第二层1004的第一部分1006和第二部分1008的联接接合，并且在切割部分10053被推进以横切第一层1002时用减小的阻力呈现切割部分10053。As described above, repeated use of the cutting portion 10053 to cut the tissue T and tissue thickness compensator material may blunt the cutting portion 10053 . To slow down the passivation process, it may be desirable to reduce the tissue thickness compensator material cut by the cutting portion 10053 . An additional benefit may be a reduction in the force required to advance the firing member 10052 distally during the firing stroke. In order to reduce passivation of the cutting portion 10053, the first layer 1002 may at least partially comprise, for example, a thin film. In such cases, the first height H1 may be significantly smaller than the second height H2 and the third height H3, as shown in FIG. 17 . In some cases, first layer 1002 may have a uniform or substantially uniform height therethrough, as shown in FIG. 17 . In other cases, gap-bridging portion 1014 of first layer 1002 may extend at least partially over gap 1010 and may be thinner than the remainder of first layer 1002 . The cutting portion 10053 can transect the gap bridging portion 1014 of the first layer 1002 while advancing through the gap 1010 between the first portion 1006 and the second portion 1008 of the second layer 1004, which can reduce the drag experienced by the cutting portion 10053 and / Or slow down the passivation of the cutting portion 10053 . In any event, the first layer 1002 can be configured to maintain coupled engagement with the first portion 1006 and the second portion 1008 of the second layer 1004 prior to being transected, and the cutting portion 10053 is advanced to transect the first portion 10053. Layer 1002 presents cut portion 10053 with reduced resistance.
为了进一步减少切割部分10053的钝化并且/或者减小切割部分10053所经受的阻力，间隙桥接部分1014可包括沿由间隙1010限定的刀路径的穿孔段1016，如图16所示。穿孔段1016可包括多个穿孔1018，所述穿孔可在例如将第一层1002组装到第二层1004之前切入第一层1002中。在切割部分10053被推进穿过由间隙1010限定的刀路径时，穿孔1018可减小切割部分10053和第一层1002之间的相互作用，这可减慢切割部分10053的钝化并且/或者减小切割部分10053所经受的阻力。To further reduce blunting of cutting portion 10053 and/or reduce drag experienced by cutting portion 10053 , gap bridging portion 1014 may include a perforated segment 1016 along the knife path defined by gap 1010 , as shown in FIG. 16 . Perforated section 1016 may include a plurality of perforations 1018 that may be cut into first layer 1002 prior to assembling first layer 1002 to second layer 1004 , for example. As the cutting portion 10053 is advanced through the knife path defined by the gap 1010, the perforations 1018 can reduce the interaction between the cutting portion 10053 and the first layer 1002, which can slow down the passivation of the cutting portion 10053 and/or reduce the The resistance experienced by the small cutting portion 10053.
在各种情况下，如下文更详细地描述，组织厚度补偿件组件1000可由一种或多种生物相容性材料构成。在某些情况下，第一层1002可由例如生物相容性支撑材料和/或塑性材料(诸如聚二氧六环酮(PDS)和/或聚乙醇酸(PGA))构成，并且第二层1004可由例如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。在某些情况下，第一层1002可为包含例如可生物吸收的材料的薄膜，所述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)、聚二氧六环酮(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。在某些情况下，第二层1004的第一部分1006和/或第二部分1008可由例如包含聚乳酸(PLA)和/或聚乙醇酸(PGA)的冻干泡沫构成。在某些情况下，第二层1004的第一部分1006和/或第二部分1008可由生物相容性泡沫构成，该生物相容性泡沫可包括多孔的开孔泡沫和/或多孔的闭孔泡沫。In various cases, as described in more detail below, tissue thickness compensator assembly 1000 can be constructed of one or more biocompatible materials. In some cases, the first layer 1002 can be composed of, for example, a biocompatible support material and/or a plastic material such as polydioxanone (PDS) and/or polyglycolic acid (PGA), and the second layer 1004 may be constructed of, for example, a bioabsorbable foam material and/or a compressible hemostatic material such as oxidized regenerated cellulose (ORC). In some cases, the first layer 1002 may be a film comprising, for example, a bioabsorbable material such as polyglycolic acid (PGA), polylactic acid (PLA or PLLA) sold under the tradename Vicryl. , polydioxanone (PDS), polyhydroxyalkanoate (PHA), polycapron 25 (PGCL) sold under the tradename Monocryl, polycaprolactone (PCL), and/or PGA, PLA , PDS, PHA, PGCL and/or PCL complexes. In some cases, the first portion 1006 and/or the second portion 1008 of the second layer 1004 can be composed of, for example, a freeze-dried foam comprising polylactic acid (PLA) and/or polyglycolic acid (PGA). In some cases, the first portion 1006 and/or the second portion 1008 of the second layer 1004 can be composed of a biocompatible foam, which can include a porous open-cell foam and/or a porous closed-cell foam .
再次参见图15和图17，第一层1002可至少部分地设置在第二层1004上，使得当组织厚度补偿件组件1000组装有端部执行器22090(图9)时，第二层1004可定位在第一层1002和平台表面22011(图9)之间。在其他情况下，第一层1002可定位在第一部分1006和第二部分1008(未示出)下，使得当组织厚度补偿件组件1000组装有端部执行器22090(图9)时，第一层1002可定位在第二层1004和平台表面22011(图9)之间。在任何情况下，第一层1002可附接到第二层1004的第一部分1006的第一接触表面1020和第二部分1008的第二接触表面1022。第一层1002可通过涉及施加热量和/或压力的热压制过程而附接到第二层1004，如下文中更详细地描述。在其他情况下，第一层1002可通过例如生物相容性粘合剂材料诸如纤维蛋白和/或蛋白水凝胶附接到第二层1004。本公开设想了用于将第一层1002附接到第二层1004的其他方式。Referring again to FIGS. 15 and 17 , the first layer 1002 can be at least partially disposed on the second layer 1004 such that when the tissue thickness compensator assembly 1000 is assembled with the end effector 22090 ( FIG. 9 ), the second layer 1004 can Positioned between the first layer 1002 and the platform surface 22011 (FIG. 9). In other cases, first layer 1002 may be positioned under first portion 1006 and second portion 1008 (not shown), such that when tissue thickness compensator assembly 1000 is assembled with end effector 22090 ( FIG. 9 ), the first Layer 1002 may be positioned between second layer 1004 and deck surface 22011 (FIG. 9). In any event, first layer 1002 may be attached to first contact surface 1020 of first portion 1006 and second contact surface 1022 of second portion 1008 of second layer 1004 . The first layer 1002 may be attached to the second layer 1004 by a hot pressing process involving the application of heat and/or pressure, as described in more detail below. In other cases, first layer 1002 may be attached to second layer 1004 by, for example, a biocompatible adhesive material such as fibrin and/or protein hydrogel. This disclosure contemplates other ways for attaching the first layer 1002 to the second layer 1004 .
现在参见图21和图22，第一层1002可至少部分地嵌入第二层1004的第一部分1006和/或第二部分1008中。在此类情况下，组织厚度补偿件组件1000可使用模具1024来制备，例如如图21所示。在各种情况下，可将包含聚合物(诸如聚乳酸(PLA)和/或聚乙醇酸(PGA))的有机溶液倾倒入模具1024中。可将第一层1002浸入有机溶液中。如图22所示，模具盖1028的中心架1026和中心梁1027可将第一层1002夹在两者间以确保第一层1002保持浸入有机溶液中，该有机溶液然后可使用例如常规冻干技术和/或任何其他合适的技术来冻干。在完成冻干过程和/或任何其他合适的过程之后，模具盖1028可被移除并且组织厚度补偿件组件1000可从模具1028回收。Referring now to FIGS. 21 and 22 , the first layer 1002 can be at least partially embedded in the first portion 1006 and/or the second portion 1008 of the second layer 1004 . In such cases, tissue thickness compensator assembly 1000 may be prepared using mold 1024, such as shown in FIG. 21 . In various cases, an organic solution comprising a polymer such as polylactic acid (PLA) and/or polyglycolic acid (PGA) may be poured into mold 1024 . The first layer 1002 may be immersed in an organic solution. As shown in FIG. 22 , the center frame 1026 and center beam 1027 of the mold cover 1028 can sandwich the first layer 1002 therebetween to ensure that the first layer 1002 remains submerged in an organic solution, which can then be dried using, for example, conventional lyophilization. technique and/or any other suitable technique for lyophilization. After completion of the lyophilization process and/or any other suitable process, the mold cover 1028 can be removed and the tissue thickness compensator assembly 1000 can be recovered from the mold 1028 .
如图21所示，组织厚度补偿件1000的第一层1002可部分地定位在第二层1004的第一部分1006和第二部分1008内。在某些情况下，第一层1002可部分地定位在第一部分1006和第二部分1008中的一者内并且附接到第一部分1006和第二部分1008中的另一者的顶部表面或底部表面。As shown in FIG. 21 , first layer 1002 of tissue thickness compensator 1000 can be positioned partially within first portion 1006 and second portion 1008 of second layer 1004 . In some cases, first layer 1002 may be partially positioned within one of first portion 1006 and second portion 1008 and attached to the top surface or bottom of the other of first portion 1006 and second portion 1008 surface.
在某些情况下，当盖1028与模具1024处于闭合构型时，中心梁1027和架1026可至少部分地沿平行于或基本上平行于第一平台接触表面1007和/或第二平台接触表面1009的轴线延伸，如图22所示。在此类情况下，第一层1002可嵌入第一部分1006和/或第二部分1008中，使得第一层1002以与第一平台接触表面1007和/或第二平台接触表面1009平行或基本上平行的关系定位或基本上定位。在其他情况下，虽然未示出，但当盖1028与模具1024处于闭合构型时，中心梁1027和架1026可至少部分地沿与第一平台接触表面1007和/或第二平台接触表面1008成斜角的轴线延伸。在此类情况下，第一层1002可嵌入第一部分1006和/或第二部分1008中，使得第一层1002相对于第一平台接触表面1007和/或第二平台接触表面1009以斜角定位或基本上定位。本公开设想到用于将第一层1002部分地嵌入第一部分1006和/或第二部分1008中的其他技术。In some cases, when the cover 1028 and the mold 1024 are in the closed configuration, the central beam 1027 and the frame 1026 can be at least partially along a direction parallel or substantially parallel to the first platform contacting surface 1007 and/or the second platform contacting surface. The axis of 1009 extends as shown in FIG. 22 . In such cases, the first layer 1002 may be embedded in the first portion 1006 and/or the second portion 1008 such that the first layer 1002 is parallel to or substantially parallel to the first platform contact surface 1007 and/or the second platform contact surface 1009 Parallel relational positioning or substantially positioning. In other cases, although not shown, when the cover 1028 and the mold 1024 are in the closed configuration, the center beam 1027 and the shelf 1026 may be at least partially along the first platform contact surface 1007 and/or the second platform contact surface 1008. The axis extends at an angle. In such cases, the first layer 1002 may be embedded in the first portion 1006 and/or the second portion 1008 such that the first layer 1002 is positioned at an oblique angle relative to the first platform contacting surface 1007 and/or the second platform contacting surface 1009 Or basically positioning. This disclosure contemplates other techniques for partially embedding first layer 1002 in first portion 1006 and/or second portion 1008 .
现在参见图18和图19，示出了在许多方面类似于组织厚度补偿件组件1000和组织厚度补偿件20020的组织厚度补偿件组件1033。组织厚度补偿件组件1033可包括可间隔开并且由多个桥接构件或连接器1030可分离地联接在一起的第一部分1006和第二部分1008，所述桥接构件或连接器可跨第一部分1006和第二部分1008之间的间隙1010延伸。另外，组织厚度补偿件组件1033的连接器1030中的一些或全部可部分地嵌入第一部分1006和第二部分1008中，如图19所示。此外，连接器1030中的一些或全部可包括定位在第一部分1006内的第一端部、定位在第二部分1008内的第二端部，以及两者间的间隙桥接部分1032。间隙桥接部分1032可跨第一部分1006和第二部分1008之间的间隙1010延伸，如图19所示。连接器1030可沿间隙1010的长度间隔开以将第一部分1006可分离地联接到第二部分1008。Referring now to FIGS. 18 and 19 , there is shown a tissue thickness compensator assembly 1033 that is similar in many respects to tissue thickness compensator assembly 1000 and tissue thickness compensator 20020 . The tissue thickness compensator assembly 1033 can include a first portion 1006 and a second portion 1008 that can be spaced apart and detachably coupled together by a plurality of bridging members or connectors 1030 that can span the first portion 1006 and the second portion. The gap 1010 between the second portions 1008 extends. Additionally, some or all of the connectors 1030 of the tissue thickness compensator assembly 1033 may be partially embedded in the first portion 1006 and the second portion 1008, as shown in FIG. 19 . Additionally, some or all of the connectors 1030 may include a first end positioned within the first portion 1006, a second end positioned within the second portion 1008, and a gap bridging portion 1032 therebetween. Gap bridging portion 1032 may extend across gap 1010 between first portion 1006 and second portion 1008 , as shown in FIG. 19 . Connectors 1030 may be spaced apart along the length of gap 1010 to detachably couple first portion 1006 to second portion 1008 .
在某些情况下，连接器1030可沿着沿间隙1010延伸的轴线均匀地分布，如图19所示。在其他情况下，虽然未示出，但连接器1030可沿着沿间隙1010延伸的轴线不均匀地分布。切割部分10053可被构造成能够在切割部分10053在第一部分1006和第二部分1008之间推进穿过由间隙1010限定的刀路径时横切连接器1030的间隙桥接部分1032。在连接器1030沿着沿第一部分1006和第二部分延伸的轴线不均匀地分布的情况下，在至少一种情况下，连接器1030在间隙1010的远侧节段处可比在间隙1010的近侧节段处以更大的频率并且/或者更靠近彼此来设置，使得切割部分10053在沿由间隙1010限定的刀路径推进时可经受增加的阻力。在其他情况下，连接器1030在间隙1010的近侧节段处可比在间隙1010的远侧节段处以更大的频率并且/或者更靠近彼此来设置，例如使得切割部分10053在沿由间隙1010限定的刀路径推进时可经受减小的阻力。In some cases, connectors 1030 may be evenly distributed along an axis extending along gap 1010 , as shown in FIG. 19 . In other cases, although not shown, connectors 1030 may be unevenly distributed along an axis extending along gap 1010 . Cutting portion 10053 can be configured to transect gap-bridge portion 1032 of connector 1030 as cutting portion 10053 is advanced through the knife path defined by gap 1010 between first portion 1006 and second portion 1008 . Where the connectors 1030 are unevenly distributed along the axis extending along the first portion 1006 and the second portion, in at least one instance, the connectors 1030 may be at the distal segment of the gap 1010 more than at the proximal segment of the gap 1010. The side segments are positioned with greater frequency and/or closer to each other such that cutting portions 10053 may experience increased resistance as they advance along the knife path defined by gap 1010 . In other cases, the connectors 1030 may be disposed at a greater frequency and/or closer to each other at the proximal segment of the gap 1010 than at the distal segment of the gap 1010, for example such that the cutting portions 10053 are positioned along the gap 1010 The defined tool path may be advanced with reduced resistance.
在某些情况下，连接器1030可在可平行于或基本上平行于第一平台接触部分1007和/或第二平台接触部分1009的单个平面中延伸或基本上延伸，如图19所示。在其他情况下，虽然未示出，但连接器1030可沿可彼此平行或基本上彼此平行以及/或者平行于或基本上平行于第一平台接触部分1007和/或第二平台接触部分1009的多个平面延伸或基本上延伸。In some cases, connector 1030 may extend or substantially extend in a single plane that may be parallel or substantially parallel to first platform contact portion 1007 and/or second platform contact portion 1009 , as shown in FIG. 19 . In other cases, although not shown, the connectors 1030 may be along an axis that may be parallel or substantially parallel to each other and/or parallel or substantially parallel to the first platform contact portion 1007 and/or the second platform contact portion 1009. The multiple planes extend or substantially extend.
对上文进行进一步描述，连接器1030的间隙桥接部分1032中的一些或全部可比其相应连接器1030的其余部分薄以在切割部分10053被推进以横切连接器1030时使切割部分10053呈现在减小的阻力下，同时维持第二层1004的第一部分1006和第二部分1008的联接接合。例如，连接器1030中的一些或全部可包括狗骨形状，该狗骨形状具有终止在第二层1004的第一部分1006和第二部分1008内的较厚端部和在其间延伸的较薄中心部分。在某些情况下，连接器1030可各自由一段缝合线构成，该缝合线可由可生物吸收的材料构成，所述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)、聚二氧六环酮(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。Further to the above, some or all of the gap bridging portions 1032 of the connectors 1030 may be thinner than the rest of their respective connectors 1030 so that the cutting portions 10053 appear in the The coupled engagement of the first portion 1006 and the second portion 1008 of the second layer 1004 is simultaneously maintained with reduced resistance. For example, some or all of the connectors 1030 may include a dog-bone shape with thicker ends terminating in the first portion 1006 and the second portion 1008 of the second layer 1004 and a thinner center extending therebetween. part. In some cases, connectors 1030 may each be constructed from a length of suture that may be constructed from a bioabsorbable material such as polyglycolic acid (PGA), poly Lactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate (PHA), polycaprone 25 sold under the trade name Monocryl (PGCL), polycaprolactone (PCL), and/or complexes of PGA, PLA, PDS, PHA, PGCL and/or PCL.
再次参见图18，组织厚度补偿件组件1033可使用模具1034来制备。可将包含聚合物(诸如聚乳酸(PLA)和/或聚乙醇酸(PGA))的有机溶液倾倒入模具1034中。可将连接器1030浸入有机溶液中。如图18所示，连接器1030中的一个或多个可各自由从模具盖1038延伸的一个或多个梁1039夹在中心架1036上的一个或多个专用狭槽1040中并且被构造成能够用于在模具盖1038与模具1034处于闭合构型时与狭槽1040配合接合以确保连接器1030保持浸没在有机溶液中。狭槽1040的尺寸可被设定成接收或至少部分地接收桥接部分1032，当模具盖1038与模具1034处于闭合构型时，该桥接部分可由梁1039固定。连接器1030的从间隙桥接部分1032延伸的端部可在有机溶液中自由漂浮。另选地，连接器1030的端部可被固定到例如模具1034的侧面。在某些情况下，连接器1030可在模具1034的侧面之间在有机溶液中拉伸。在其他情况下，连接器1030可松散地保持在模具1034的侧面之间以便例如以非线性方式延伸穿过有机溶液。Referring again to FIG. 18 , tissue thickness compensator assembly 1033 may be prepared using mold 1034 . An organic solution comprising a polymer such as polylactic acid (PLA) and/or polyglycolic acid (PGA) may be poured into mold 1034 . The connector 1030 may be immersed in an organic solution. As shown in FIG. 18 , one or more of the connectors 1030 may each be clamped in one or more dedicated slots 1040 on the center frame 1036 by one or more beams 1039 extending from the mold cover 1038 and configured to Can be used to matingly engage the slot 1040 when the mold cover 1038 is in the closed configuration with the mold 1034 to ensure that the connector 1030 remains submerged in the organic solution. Slot 1040 may be sized to receive, or at least partially receive, bridge portion 1032 which may be secured by beam 1039 when mold cover 1038 and mold 1034 are in the closed configuration. The end of the connector 1030 extending from the gap bridging portion 1032 may float freely in the organic solution. Alternatively, the ends of the connector 1030 may be secured to the side of the mold 1034, for example. In some cases, connector 1030 may be stretched in an organic solution between the sides of mold 1034 . In other cases, the connector 1030 may be held loosely between the sides of the mold 1034 so as to extend through the organic solution in a non-linear fashion, for example.
对上文进行进一步描述，在各种情况下，然后有机溶液可使用常规冻干技术和/或任何其他合适的技术来冻干。在完成冻干过程之后，模具盖1036可被移除并且组织厚度补偿件组件1033可从模具1034回收。如图19所示，所得组织厚度补偿件组件1033包括部分地定位在第一部分1006和第二部分1008内的连接器1030。本公开设想到用于将连接器1030部分地嵌入第一部分1006和/或第二部分1008中的其他技术。读者将理解，连接器1030可通过改变中心架1038的高度和/或狭槽1040的深度而更靠近或更远离平台接触表面1007和1009定位。Further to the above, in each case the organic solution may then be lyophilized using conventional lyophilization techniques and/or any other suitable technique. After the lyophilization process is complete, the mold cover 1036 can be removed and the tissue thickness compensator assembly 1033 can be recovered from the mold 1034 . As shown in FIG. 19 , the resulting tissue thickness compensator assembly 1033 includes connector 1030 positioned partially within first portion 1006 and second portion 1008 . This disclosure contemplates other techniques for partially embedding connector 1030 in first portion 1006 and/or second portion 1008 . The reader will understand that the connector 1030 can be positioned closer or further from the platform contact surfaces 1007 and 1009 by changing the height of the center frame 1038 and/or the depth of the slot 1040 .
现在参见图20，示出在许多方面类似于组织厚度补偿件组件1033、组织厚度补偿件组件1000和/或组织厚度补偿件20020的组织厚度补偿件组件1042。组织厚度补偿件组件1042可包括可间隔开并且由可由多个桥接构件或连接器1046形成的连续柔性构件1044可分离地联接在一起的第一部分1006和第二部分1008，所述桥接构件或连接器可跨第一部分1006和第二部分1008之间的间隙1010延伸。连续柔性构件1044可包括第一端部1048、第二端部1050，以及在第一端部1048和第二端部1050之间延伸的柔性部分1052。柔性部分1052可被构造成能够例如以之字形图案延伸穿过第一部分1006和第二部分1008若干次以形成连接器1046，如图20所示。柔性部分1052可沿第一方向穿过第一部分1006的远侧节段1054和第二部分1008的远侧节段1056以跨间隙1010形成第一间隙桥接部分1046a。柔性部分1052然后可沿与第一方向相反的第二方向循环并穿过在远侧节段1056近侧的第二部分1008并且穿过在远侧节段1054近侧的第一部分1006，从而形成在第一间隙桥接部分1046a近侧的第二间隙桥接部分1046b。附加间隙桥接部分1046c和1046d例如可以相同方式跨间隙1010形成，如图20所示。Referring now to FIG. 20 , there is shown a tissue thickness compensator assembly 1042 that is similar in many respects to tissue thickness compensator assembly 1033 , tissue thickness compensator assembly 1000 , and/or tissue thickness compensator 20020 . The tissue thickness compensator assembly 1042 can include a first portion 1006 and a second portion 1008 that can be spaced apart and detachably coupled together by a continuous flexible member 1044 that can be formed by a plurality of bridging members or connectors 1046 that connect The filter can extend across the gap 1010 between the first portion 1006 and the second portion 1008. The continuous flexible member 1044 can include a first end 1048 , a second end 1050 , and a flexible portion 1052 extending between the first end 1048 and the second end 1050 . Flexible portion 1052 may be configured to extend across first portion 1006 and second portion 1008 several times, eg, in a zigzag pattern, to form connector 1046 , as shown in FIG. 20 . Flexible portion 1052 may pass through distal segment 1054 of first portion 1006 and distal segment 1056 of second portion 1008 in a first direction to form first gap bridging portion 1046a across gap 1010 . Flexible portion 1052 may then loop in a second direction opposite to the first direction and pass through second portion 1008 proximal to distal segment 1056 and through first portion 1006 proximal to distal segment 1054, thereby forming A second gap bridging portion 1046b proximal to the first gap bridging portion 1046a. Additional gap bridging portions 1046c and 1046d may be formed across gap 1010 in the same manner, for example, as shown in FIG. 20 .
在某些情况下，连续柔性构件1044可包括缝合线并且可由缝合线材料构成，所述缝合线材料诸如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚二氧六环酮(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。在某些情况下，组织厚度补偿件组件1042可在第一部分1006和第二部分1008例如通过冻干制造之后来组装。在一些情况下，针(未示出)可附接到连续柔性构件1044的第一端部1048并且可例如以之字形图案穿过第一部分1006和第二部分1008以将第一部分1006联接到第二部分1008，如上所述。连续柔性构件1044的第一端部1048和/或第二端部1050可通过在例如第一端部1048和/或第二端部1050处系紧一个或多个结而固定到第一部分1006和/或第二部分1008的侧壁。结可紧靠第一部分1006和/或第二部分1008的侧壁以防止柔性部分1052相对于第一部分1006和/或第二部分1008解开。在其他情况下，组织厚度补偿件组件1042的第一部分1006和第二部分1008可围绕连续柔性构件1044形成。在此类情况下，如图20所示，连续柔性构件1044可例如以之字形图案设置在模具1062中，其中狭槽1064限定在侧壁1066中并且狭槽1068限定在中心架1070中。可将包含聚合物(诸如聚乳酸(PLA)和/或聚乙醇酸(PGA))的有机溶液倾倒入模具1062中，直到连续柔性构件1044浸没在有机溶液中。模具盖1072可用于确保连续柔性构件1044保持浸没在有机溶液中，该有机溶液然后使用常规冻干技术和/或任何其他合适的技术来冻干。在例如使第一端部1048穿过开口1053并且使第二端部1050穿过开口1055之后，连续柔性构件1044的第一端部1048和第二端部1050可通过在第一端部1048和第二端部1050处系紧一个或多个结而分别固定在模具1062的开口1053和1055处。结可紧靠模具1062的侧壁以防止连续柔性构件1044相对于模具1066解开。在组织厚度补偿件已从模具移除之后，在各种情况下，连续柔性构件1044的部分(诸如部分1048、1050和/或1052)然后可被切割并且从组织厚度补偿件移除。本公开设想到用于组装组织厚度补偿件组件1042的其他技术。In some cases, the continuous flexible member 1044 may comprise suture and may be constructed of a suture material such as polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydimeric acid sold under the trade name Vicryl, Oxyhexanone (PDS), polyhydroxyalkanoate (PHA), polycapron 25 (PGCL) sold under the tradename Monocryl, polycaprolactone (PCL), and/or PGA, PLA, PDS, Complexes of PHA, PGCL and/or PCL. In some cases, tissue thickness compensator assembly 1042 may be assembled after first portion 1006 and second portion 1008 are manufactured, such as by lyophilization. In some cases, a needle (not shown) may be attached to first end 1048 of continuous flexible member 1044 and may pass through first portion 1006 and second portion 1008 , for example, in a zigzag pattern, to couple first portion 1006 to second portion 1006 . Part two 1008, as described above. The first end 1048 and/or the second end 1050 of the continuous flexible member 1044 can be secured to the first portion 1006 and and/or the sidewall of the second portion 1008 . The knot may abut against a sidewall of the first portion 1006 and/or the second portion 1008 to prevent the flexible portion 1052 from unraveling relative to the first portion 1006 and/or the second portion 1008 . In other cases, first portion 1006 and second portion 1008 of tissue thickness compensator assembly 1042 may be formed around continuous flexible member 1044 . In such cases, as shown in FIG. 20 , continuous flexible member 1044 may be disposed in mold 1062 , eg, in a zigzag pattern, with slots 1064 defined in sidewalls 1066 and slots 1068 defined in center frame 1070 . An organic solution comprising a polymer such as polylactic acid (PLA) and/or polyglycolic acid (PGA) may be poured into mold 1062 until continuous flexible member 1044 is submerged in the organic solution. Mold cover 1072 may be used to ensure that continuous flexible member 1044 remains submerged in the organic solution, which is then lyophilized using conventional lyophilization techniques and/or any other suitable technique. First end 1048 and second end 1050 of continuous flexible member 1044 may pass between first end 1048 and One or more knots are fastened at the second end 1050 to secure at openings 1053 and 1055 of the mold 1062, respectively. Knots may abut against sidewalls of mold 1062 to prevent unwinding of continuous flexible member 1044 relative to mold 1066 . After the tissue thickness compensator has been removed from the mold, portions of the continuous flexible member 1044, such as portions 1048, 1050, and/or 1052, may then be cut and removed from the tissue thickness compensator, in various cases. This disclosure contemplates other techniques for assembling tissue thickness compensator assembly 1042 .
在某些情况下，当将过大的力或压力施加到组织厚度补偿件组件(诸如组织厚度补偿件组件1042)时，其可损坏。例如，当将组织厚度补偿件组件1042装载到钉仓(诸如钉仓10000)上时，可将压力施加到组织厚度补偿件组件(诸如组织厚度补偿件组件1042)上。组织厚度补偿件组件1042可装配有压力或力敏感构件，该压力或力敏感构件可向使用者提供组织厚度补偿件组件所经受的压力是否超过阈值的警告反馈。例如，压力或力敏感膜可附接到组织厚度补偿件组件1042并且可被构造成能够在经受超过阈值的压力时改变颜色。在某些情况下，压力或力敏感膜可被设置在第一部分1006和/或第二部分1008上方并且可通过例如粘合剂附接到其上。压力或力敏感膜可以是生物相容的以允许用组织厚度补偿件组件1042将压力或力敏感膜植入患者体内。In some instances, a tissue thickness compensator assembly, such as tissue thickness compensator assembly 1042, can be damaged when excessive force or pressure is applied to it. For example, when tissue thickness compensator assembly 1042 is loaded onto a staple cartridge, such as staple cartridge 10000, pressure can be applied to tissue thickness compensator assembly, such as tissue thickness compensator assembly 1042. The tissue thickness compensator assembly 1042 may be equipped with a pressure or force sensitive member that may provide warning feedback to the user whether the pressure experienced by the tissue thickness compensator assembly exceeds a threshold. For example, a pressure or force sensitive membrane may be attached to the tissue thickness compensator assembly 1042 and may be configured to change color when subjected to pressure above a threshold. In some cases, a pressure or force sensitive membrane may be disposed over first portion 1006 and/or second portion 1008 and may be attached thereto by, for example, an adhesive. The pressure or force sensitive membrane may be biocompatible to allow the tissue thickness compensator assembly 1042 to implant the pressure or force sensitive membrane in a patient.
现在参见图23至图25，示出了外科端部执行器1100。端部执行器1100在许多方面类似于本文在别处公开的各种端部执行器，诸如端部执行器22090(图9)。如图23所示，端部执行器1100可包括例如在许多方面类似于钉仓组件20200(图6)的钉仓组件1102。另外，端部执行器1100可包括例如在许多方面类似于本文件在别处所公开的其他组织厚度补偿件(诸如组织厚度补偿件22020(图9)、组织厚度补偿件20220(图6)和/或组织厚度补偿件10020(图4))的组织厚度补偿件1104。Referring now to FIGS. 23-25 , a surgical end effector 1100 is shown. End effector 1100 is similar in many respects to various end effectors disclosed elsewhere herein, such as end effector 22090 (FIG. 9). As shown in FIG. 23, end effector 1100 can include, for example, a cartridge assembly 1102 that is similar in many respects to cartridge assembly 20200 (FIG. 6). Additionally, end effector 1100 may include, for example, other tissue thickness compensators similar in many respects to those disclosed elsewhere in this document, such as tissue thickness compensator 22020 (FIG. 9), tissue thickness compensator 20220 (FIG. 6), and/or or tissue thickness compensator 10020 (FIG. 4)).
对上文进行进一步描述，端部执行器1100可包括组织厚度补偿件1104，其中组织厚度补偿件1104可使用常规冻干技术和/或任何其他合适的技术来制备。在至少一个示例中，组织厚度补偿件1104可通过使聚合物(诸如聚乳酸(PLA)和/或聚乙醇酸(PGA))溶解于有机溶剂中并且使溶液冻干来制备。组织厚度补偿件1104可由生物相容性泡沫构成，该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。Further to the above, end effector 1100 can include tissue thickness compensator 1104, wherein tissue thickness compensator 1104 can be prepared using conventional freeze-drying techniques and/or any other suitable technique. In at least one example, the tissue thickness compensator 1104 can be prepared by dissolving a polymer, such as polylactic acid (PLA) and/or polyglycolic acid (PGA), in an organic solvent and lyophilizing the solution. The tissue thickness compensator 1104 can be constructed of a biocompatible foam, which can include, for example, porous open-cell foam and/or porous closed-cell foam.
对上文进行进一步描述，组织厚度补偿件1104可被改变或修改以用于外科手术中。例如，在完成冻干过程之后，组织厚度补偿件1104可与修改构件1106接触以修改组织厚度补偿件1104以用于特定外科手术中。在某些情况下，修改可在将组织厚度补偿件1104组装有端部执行器1100之后进行，如图23至图35所示。例如，如图23所示，组织厚度补偿件1104可以可释放地组装到仓组件1102并且在组装有仓组件1102时修改。在其他情况下，修改可在将组织厚度补偿件1104组装有端部执行器1100之前进行。在至少一个示例中，在制造期间，修改可作为单独的步骤进行。在又一个示例中，修改可在外科手术期间进行。Further to the above, the tissue thickness compensator 1104 may be altered or modified for use in a surgical procedure. For example, after the freeze drying process is complete, tissue thickness compensator 1104 may be contacted with modification member 1106 to modify tissue thickness compensator 1104 for use in a particular surgical procedure. In some cases, modifications may be made after tissue thickness compensator 1104 is assembled with end effector 1100, as shown in FIGS. 23-35. For example, as shown in FIG. 23 , tissue thickness compensator 1104 may be releasably assembled to cartridge assembly 1102 and modified while cartridge assembly 1102 is assembled. In other cases, modifications may be made prior to assembling tissue thickness compensator 1104 with end effector 1100 . In at least one example, modification can be performed as a separate step during manufacture. In yet another example, modification may be performed during surgery.
如下文更详细地描述，修改过程可涉及修改组织厚度补偿件1104的表面或多个表面。在某些情况下，修改过程可涉及修改组织厚度补偿件1104的一个或多个部分。一个或多个部分可在单个修改过程中修改。另选地，多个部分可各自在连续修改过程中单独地修改。在某些情况下，修改过程可包括热压制过程，该热压制过程可用于改变组织厚度补偿件1104的至少一部分的形状、大小、尺寸和/或孔隙度。此外，修改过程可包括用于在组织厚度补偿件1104的一个或多个部分内形成空间的方式。As described in more detail below, the modification process may involve modifying the surface or surfaces of the tissue thickness compensator 1104 . In some cases, the modification process may involve modifying one or more portions of the tissue thickness compensator 1104 . One or more sections may be modified in a single modification process. Alternatively, multiple sections may each be modified individually in a sequential modification process. In some cases, the modifying process can include a thermal pressing process that can be used to alter the shape, size, dimension, and/or porosity of at least a portion of the tissue thickness compensator 1104 . Additionally, the modification process may include means for creating spaces within one or more portions of the tissue thickness compensator 1104 .
再次参见图23至图25，在某些情况下，组织厚度补偿件1104的部分1107(图23)可通过热压制过程来修改，该热压制过程可包括将部分1107转变成玻璃态，将部分1107与修改构件1106接合，在部分1107处于玻璃态时将压力施加到其上，以及使部分1107冷却到玻璃态之下，同时修改构件1106仍与部分1107接合。修改构件1106可用于维持部分1107上的压力持续足以形成所得修改部分1108(图25)的时间段。值得注意的是，材料到玻璃态的转变可为响应于材料的温度增加到玻璃化转变温度而从相对较硬状态到相对熔融或柔性状态的可逆转变。材料的玻璃化转变温度可为特定温度，或者在一些情况下为一定的温度范围。本文所述的组织厚度补偿件修改过程通过以下方式来利用该现象：在组织厚度补偿件处于玻璃柔性状态时修改组织厚度补偿件，然后在维持修改时使组织厚度补偿件冷却到玻璃化转变温度以下。Referring again to FIGS. 23-25 , in some cases, portion 1107 ( FIG. 23 ) of tissue thickness compensator 1104 may be modified by a thermal pressing process, which may include transforming portion 1107 into a glassy state, 1107 engages modifying member 1106, applies pressure to portion 1107 while it is in the glassy state, and cools portion 1107 below the glassy state while modifying member 1106 remains engaged to portion 1107. Modification member 1106 may be used to maintain pressure on portion 1107 for a period of time sufficient to form the resulting modified portion 1108 (FIG. 25). Notably, the transition of a material to a glassy state may be a reversible transition from a relatively harder state to a relatively molten or flexible state in response to the temperature of the material increasing to the glass transition temperature. The glass transition temperature of a material may be a specific temperature, or in some cases a range of temperatures. The tissue thickness compensator modification process described herein takes advantage of this phenomenon by modifying the tissue thickness compensator while it is in a glassy flexible state and then cooling the tissue thickness compensator to the glass transition temperature while maintaining the modification the following.
对上文进行进一步描述，再次参见图23至图25，组织厚度补偿件1004的部分1107可通过以下方式而转变成玻璃态：至少将部分1107加热到大于或等于材料的玻璃化转变温度但是低于其熔融温度的温度，部分1107由所述材料构成。例如，组织厚度补偿件1104可由聚乙醇酸(PGA)构成，并且在此类情况下，部分1107可通过以下方式转变成玻璃态：将部分1107加热到大于或等于聚乙醇酸(PGA)的玻璃化转变温度但是低于其熔融温度的温度。在各种情况下，聚乙醇酸(PGA)的玻璃化转变温度可在例如35-40℃的范围内，并且其熔融温度可在例如225-230℃的范围内。在至少一个示例中，组织厚度补偿件1104的部分1107可被加热到大于或等于35℃但低于225℃的温度，以便将部分1107转变成玻璃态。在另一个示例中，部分1107可通过以下方式转变成玻璃态：将部分1107加热到例如大于或等于40℃但低于200℃的温度。Further to the above, referring again to FIGS. 23-25 , portion 1107 of tissue thickness compensator 1004 may be transformed into a glassy state by heating at least portion 1107 to a temperature greater than or equal to the glass transition temperature of the material but lower than that of the material. At the temperature of its melting temperature, portion 1107 is composed of the material. For example, tissue thickness compensator 1104 may be composed of polyglycolic acid (PGA), and in such cases, portion 1107 may be transformed into a glassy state by heating portion 1107 to a temperature greater than or equal to that of the polyglycolic acid (PGA) glass. transition temperature but below its melting temperature. In each case, the glass transition temperature of polyglycolic acid (PGA) may be in the range of, for example, 35-40°C, and its melting temperature may be in the range of, for example, 225-230°C. In at least one example, portion 1107 of tissue thickness compensator 1104 can be heated to a temperature greater than or equal to 35° C. but less than 225° C. to transform portion 1107 into a glassy state. In another example, portion 1107 may be transformed into a glassy state by heating portion 1107 to a temperature, eg, greater than or equal to 40°C but less than 200°C.
对上文进行进一步描述，修改构件1106然后可用于在部分1107处于玻璃态时将压力施加到部分1107上。可通过例如将部分1107冷却到低于35℃的温度而使部分1107退出玻璃态。可将压力维持足以允许组织厚度补偿件1104保持或至少部分地保持由修改构件1106施加的修改的时间段。Further to the above, the modifying member 1106 may then be used to apply pressure to the portion 1107 while the portion 1107 is in the glassy state. Portion 1107 may be brought out of the glassy state by, for example, cooling portion 1107 to a temperature below 35°C. Pressure may be maintained for a period of time sufficient to allow tissue thickness compensator 1104 to maintain, or at least partially maintain, the modification applied by modification member 1106 .
在某些实施例中，压力可例如在处于玻璃态的时间期间维持约30秒至约8小时的时间段并且/或者例如在退出玻璃态之后维持约30秒至约8小时的时间段。在至少一个示例中，压力可在处于玻璃态的时间期间维持大约10分钟并且在退出玻璃态之后维持大约10分钟。本公开设想到用于维持压力的其他时间段。In certain embodiments, the pressure may be maintained for a period of about 30 seconds to about 8 hours, for example, during the time in the glass state and/or for a period of about 30 seconds to about 8 hours, for example, after exiting the glass state. In at least one example, the pressure can be maintained for about 10 minutes during the time in the glass state and for about 10 minutes after exiting the glass state. This disclosure contemplates other time periods for maintaining pressure.
在某些情况下，修改构件1106可用于在部分1107转变成玻璃态之前将压力施加到部分1107上。在某些情况下，修改构件1106可在部分1107被加热以达到玻璃态时，在部分1107处于玻璃态时，以及/或者在部分1107转变或冷却到玻璃态以下的温度时向部分1107施加压力。在某些情况下，例如在部分1107的温度逐渐增加以使部分1107朝玻璃态转变时，施加到部分1107的压力可逐渐朝阈值增加。在某些情况下，在部分1107退出玻璃态时，在部分1107退出玻璃态之前，以及/或者在部分1107退出玻璃态之后，施加到部分1107的压力可被移除，逐渐移除，或至少部分地减小。In some cases, modifying member 1106 may be used to apply pressure to portion 1107 before portion 1107 transitions to a glassy state. In some cases, modifying member 1106 may apply pressure to portion 1107 when portion 1107 is heated to a glassy state, while portion 1107 is in a glassy state, and/or when portion 1107 transitions or cools to a temperature below the glassy state . In some cases, the pressure applied to portion 1107 may be gradually increased toward a threshold, such as when the temperature of portion 1107 is gradually increased to transition portion 1107 toward a glassy state. In some cases, the pressure applied to portion 1107 may be removed, gradually removed, or at least partially reduced.
在某些情况下，修改构件1106还可以是用于使组织厚度补偿件1104的部分1107转变成玻璃态的热源。例如，修改构件1106可包括圆柱形远侧部分1110，如图24所示，该圆柱形远侧部分可包括加热线圈(未示出)。使用者可使加热线圈通电并且将组织厚度补偿件1104的部分1107与修改构件1106接合以将部分1107加热到大于或等于部分1107的材料组合物的玻璃化转变温度的温度。一旦达到所需温度，可抵靠部分1107按压修改构件，如图24所示。另选地，在修改构件1106达到所需温度之前，可抵靠部分1107按压修改构件。如上所述，可将压力维持足以允许组织厚度补偿件1104保持或至少部分地保持由修改构件1106施加的修改的时间段。另外，修改构件1106的加热线圈可被关闭以使部分1107的温度冷却到低于玻璃化转变温度。修改构件然后可被移除。在某些情况下，由修改构件1106施加的压力可在部分1107进入玻璃态之前被引发并且在整个玻璃态内得以维持。在一些情况下，在部分1107处于玻璃态时，由修改构件1106施加的压力可被移除。In some cases, modifying member 1106 may also be a heat source for transforming portion 1107 of tissue thickness compensator 1104 into a glassy state. For example, modification member 1106 may include a cylindrical distal portion 1110, as shown in FIG. 24, which may include a heating coil (not shown). A user may energize the heating coil and engage portion 1107 of tissue thickness compensator 1104 with modification member 1106 to heat portion 1107 to a temperature greater than or equal to the glass transition temperature of the material composition of portion 1107 . Once the desired temperature is reached, the modification member may be pressed against portion 1107 as shown in FIG. 24 . Alternatively, the modifying member may be pressed against portion 1107 before modifying member 1106 reaches a desired temperature. As described above, pressure may be maintained for a period of time sufficient to allow tissue thickness compensator 1104 to maintain, or at least partially maintain, the modification applied by modification member 1106 . Additionally, the heating coil of modification member 1106 may be turned off to cool the temperature of portion 1107 below the glass transition temperature. The modified component can then be removed. In some cases, the pressure applied by modifying member 1106 may be initiated before portion 1107 enters the glassy state and maintained throughout the glassy state. In some cases, the pressure applied by modifying member 1106 may be removed while portion 1107 is in the glassy state.
如图23至图25所示，修改构件1106可被构造成能够改变组织厚度补偿件1104的部分1107的形状、大小、尺寸、密度、弹性比率和/或孔隙度。例如，修改部分1108可包括具有减小高度H1的基本上凹形的顶部表面1114，而组织厚度补偿件1104的剩余部分可保持包括大于减小高度H1的初始高度H的基本上平坦的顶部表面，如图25所示。如上所述，修改构件1106可包括圆柱形远侧部分1110。在此类情况下，所得凹形表面1114的曲率可部分地取决于在修改过程期间与组织厚度补偿件1104的部分1107接触的修改构件1106的圆柱形远侧部分1110的曲率。此外，修改部分1108可具有与未修改部分1107相比较低的新孔隙度，这可至少部分地由在修改过程期间由修改构件1106施加到部分1107的压缩力导致，如上所述。换句话讲，在修改过程期间施加到部分1107的压力可产生材料重新分布，其中在修改过程之前通过修改部分1108的横截面可具有比通过部分1107的相似横截面大的材料密度。此外，修改部分1108可具有与组织厚度补偿件1104的剩余部分不同的弹性比率，这可部分地由在修改过程期间由修改部分1108实现的密度和孔隙度的改变而导致，如下文更详细地描述。在至少一种情况下，修改部分1108的弹性比率可小于或大于未修改部分1107的弹性比率。As shown in FIGS. 23-25 , modifying member 1106 can be configured to change the shape, size, dimension, density, elasticity ratio, and/or porosity of portion 1107 of tissue thickness compensator 1104 . For example, the modified portion 1108 can include a substantially concave top surface 1114 having a reduced height H1, while the remaining portion of the tissue thickness compensator 1104 can maintain a substantially planar top surface including an initial height H that is greater than the reduced height H1 , as shown in Figure 25. As described above, the modification member 1106 can include a cylindrical distal portion 1110 . In such cases, the curvature of the resulting concave surface 1114 may depend in part on the curvature of the cylindrical distal portion 1110 of the modification member 1106 that is in contact with the portion 1107 of the tissue thickness compensator 1104 during the modification procedure. Furthermore, modified portion 1108 may have a lower new porosity compared to unmodified portion 1107, which may result, at least in part, from compressive forces applied to portion 1107 by modifying member 1106 during the modification process, as described above. In other words, pressure applied to portion 1107 during the modification process may create material redistribution, wherein a cross section through modification portion 1108 prior to the modification process may have a greater material density than a similar cross section through portion 1107 . Additionally, the modification portion 1108 may have a different elastic ratio than the remainder of the tissue thickness compensator 1104, which may result in part from changes in density and porosity achieved by the modification portion 1108 during the modification process, as described in more detail below. describe. In at least one instance, the elastic ratio of the modified portion 1108 may be less than or greater than the elastic ratio of the unmodified portion 1107 .
现在参见图26至图34，组织厚度补偿件可在组装有端部执行器诸如端部执行器22090(图9)之前被修改。在某些情况下，如图27、图30和图33所示，模具可用于使用热压制过程修改组织厚度补偿件，如上所述。例如，如图26至图28所示，组织厚度补偿件1120可被修改为包括纵向狭槽1122。组织厚度补偿件1120可在许多方面类似于别处所述的其他组织厚度补偿件，诸如组织厚度补偿件22020(图9)。例如，如同补偿件22020，补偿件1120可与端部执行器22090一起使用。此外，纵向狭槽1122可在许多方面类似于刀狭槽22025。例如，如同刀狭槽22025，狭槽1122可将用于切割部分10053的组织厚度补偿件刀路径限定在第一缝合部分1124a和第二缝合部分1124b之间。此外，第一缝合部分1124a和第二缝合部分1124b可在许多方面分别类似于组织厚度补偿件22020的第一缝合部分22021a(图9)和第二缝合部分22021b(图9)。另外，狭槽1122可被构造成能够可释放地连接第一缝合部分1124a和第二缝合部分1124b，使得在与端部执行器22090一起使用时，切割部分10053可朝远侧推进穿过狭槽1122以横切狭槽1122并且将第一缝合部分1124a和第二缝合部分1124b分离。Referring now to FIGS. 26-34 , the tissue thickness compensator may be modified prior to assembly with an end effector such as end effector 22090 ( FIG. 9 ). In some cases, as shown in Figures 27, 30, and 33, a mold may be used to modify the tissue thickness compensator using a hot pressing process, as described above. For example, as shown in FIGS. 26-28 , tissue thickness compensator 1120 may be modified to include longitudinal slot 1122 . Tissue thickness compensator 1120 may be similar in many respects to other tissue thickness compensators described elsewhere, such as tissue thickness compensator 22020 (FIG. 9). For example, like compensator 22020 , compensator 1120 may be used with end effector 22090 . Additionally, longitudinal slot 1122 can be similar to knife slot 22025 in many respects. For example, like knife slot 22025, slot 1122 can define a tissue thickness compensator knife path for cutting portion 10053 between first stitched portion 1124a and second stitched portion 1124b. Additionally, first stitched portion 1124a and second stitched portion 1124b can be similar in many respects to first stitched portion 22021a ( FIG. 9 ) and second stitched portion 22021b ( FIG. 9 ), respectively, of tissue thickness compensator 22020 . Additionally, the slot 1122 can be configured to releasably connect the first suture portion 1124a and the second suture portion 1124b such that the cutting portion 10053 can be advanced distally through the slot when used with the end effector 22090 1122 to traverse the slot 1122 and separate the first stitched portion 1124a from the second stitched portion 1124b.
再次参见图26至图28，组织厚度补偿件1120可使用传统冻干技术和/或任何其他合适的技术来制备。另外，组织厚度补偿件1120可被修改或改变以穿过其中形成狭槽1122。类似于组织厚度补偿件1104，组织厚度补偿件1120可至少部分地由具有玻璃化转变温度的材料构成并且可通过将材料转变成玻璃态来修改。在一个示例中，组织厚度补偿件1120可在烘箱(未示出)中加热到大于或等于组织厚度补偿件1120的材料组合物的玻璃化转变温度但小于其熔融温度的温度。如图27所示，包括中心梁1128的模具1126可用于通过以下方式形成狭槽1122：在组织厚度补偿件1120处于玻璃态时将中心梁1128插入组织厚度补偿件1120中。在中心梁1128保持插入组织厚度补偿件1120中时，然后可使组织厚度补偿件1120冷却到低于玻璃化转变温度的温度。在一些情况下，在组织厚度补偿件1120处于其玻璃态时，中心梁1128可从组织厚度补偿件1120移除。Referring again to FIGS. 26-28 , tissue thickness compensator 1120 may be prepared using conventional freeze-drying techniques and/or any other suitable technique. Additionally, the tissue thickness compensator 1120 may be modified or altered to form a slot 1122 therethrough. Similar to tissue thickness compensator 1104, tissue thickness compensator 1120 can be at least partially composed of a material having a glass transition temperature and can be modified by converting the material to a glassy state. In one example, tissue thickness compensator 1120 may be heated in an oven (not shown) to a temperature greater than or equal to the glass transition temperature of the material composition of tissue thickness compensator 1120 but less than its melting temperature. As shown in FIG. 27, mold 1126 including center beam 1128 may be used to form slot 1122 by inserting center beam 1128 into tissue thickness compensator 1120 while tissue thickness compensator 1120 is in a glassy state. While the central beam 1128 remains inserted into the tissue thickness compensator 1120, the tissue thickness compensator 1120 may then be allowed to cool to a temperature below the glass transition temperature. In some cases, center beam 1128 can be removed from tissue thickness compensator 1120 while tissue thickness compensator 1120 is in its glassy state.
在某些情况下，冷却介质可用于主动地冷却组织厚度补偿件1120。在一些情况下，风扇可用于在组织厚度补偿件1120处于模具1126中时以及/或者在组织厚度补偿件1120已从模具移除之后在组织厚度补偿件1120上方生成空气流。在一些情况下，制冷过程可用于在组织厚度补偿件1120处于模具1126中时以及/或者在组织厚度补偿件1120已从模具移除之后冷却组织厚度补偿件1120。中心梁1128可在组织厚度补偿件1120转变退出玻璃态之后被移除。中心梁1128可保持插入组织厚度补偿件1120中持续足以允许组织厚度补偿件1120保持或至少基本上保持中心梁1128所占据的空间的时间段。在某些示例中，中心梁1128可例如在处于玻璃态的时间期间保持插入约30秒至约8小时的时间段并且/或者例如在退出玻璃态之后保持插入约30秒至约8小时的时间段。在至少一个示例中，中心梁1128可在处于玻璃态的时间期间保持插入大约10分钟并且在退出玻璃态之后保持插入大约10分钟。本公开可设想到用于将中心梁1128维持在组织厚度补偿件1120内的其他时间段。In some cases, a cooling medium may be used to actively cool the tissue thickness compensator 1120 . In some cases, a fan may be used to generate airflow over tissue thickness compensator 1120 while tissue thickness compensator 1120 is in mold 1126 and/or after tissue thickness compensator 1120 has been removed from the mold. In some cases, a refrigeration process may be used to cool tissue thickness compensator 1120 while tissue thickness compensator 1120 is in mold 1126 and/or after tissue thickness compensator 1120 has been removed from the mold. The center beam 1128 may be removed after the tissue thickness compensator 1120 transitions out of the glassy state. Center beam 1128 may remain inserted into tissue thickness compensator 1120 for a period of time sufficient to allow tissue thickness compensator 1120 to retain, or at least substantially retain, the space occupied by center beam 1128 . In some examples, the center beam 1128 may remain inserted for a period of about 30 seconds to about 8 hours, for example, during the time in the glass state and/or for a period of about 30 seconds to about 8 hours after exiting the glass state, for example. part. In at least one example, the center beam 1128 may remain inserted for approximately 10 minutes during the time in the glass state and for approximately 10 minutes after exiting the glass state. Other periods of time for maintaining center beam 1128 within tissue thickness compensator 1120 are contemplated by the present disclosure.
对上文进行进一步描述，如图28所示，在修改过程期间由中心梁1128施加的压力可在组织厚度补偿件1120的部分1130处产生增加的材料密度。部分1130可连接第一缝合部分1124a和第二缝合部分1124b，从而为狭槽1122提供附加稳定性。在某些情况下，模具1126可包括边缘改性剂，诸如边缘改性剂1132a和1132b，其可在修改过程期间修改组织厚度补偿件1120以分别产生修改的边缘1134a和1134b，如图28所示。Further to the above, as shown in FIG. 28 , the pressure exerted by the central beam 1128 during the modification process can create an increased material density at the portion 1130 of the tissue thickness compensator 1120 . Portion 1130 may join first stitched portion 1124a and second stitched portion 1124b to provide additional stability to slot 1122 . In some cases, mold 1126 can include edge modifiers, such as edge modifiers 1132a and 1132b, which can modify tissue thickness compensator 1120 during the modification process to produce modified edges 1134a and 1134b, respectively, as shown in FIG. 28 Show.
再次参见图26至图28，可能需要从组织厚度补偿件1120移除显著量的材料以形成狭槽1122。在此类情况下，中心梁1128可被加热到大于组织厚度补偿件1120的材料组合物的熔融温度的温度。在将加热的中心梁1128插入组织厚度补偿件1120中之后，中心梁1128可熔融穿过组织厚度补偿件1120，从而在组织厚度补偿件1120内形成用于狭槽1122的空间，如图28所示。在某些情况下，可能需要逐渐增加由中心梁1128抵靠组织厚度补偿件1120施加的压力以将中心梁1128逐渐插入组织厚度补偿件1120中。Referring again to FIGS. 26-28 , a significant amount of material may need to be removed from tissue thickness compensator 1120 to form slot 1122 . In such cases, the center beam 1128 may be heated to a temperature greater than the melting temperature of the material composition of the tissue thickness compensator 1120 . After inserting the heated center beam 1128 into the tissue thickness compensator 1120, the center beam 1128 may melt through the tissue thickness compensator 1120, thereby forming a space within the tissue thickness compensator 1120 for the slot 1122, as shown in FIG. Show. In some cases, it may be necessary to gradually increase the pressure exerted by the center beam 1128 against the tissue thickness compensator 1120 to gradually insert the center beam 1128 into the tissue thickness compensator 1120 .
在某些情况下，可能需要增加组织厚度补偿件的一个或多个表面的材料密度。如图29至图31所示，组织厚度补偿件1140可被修改或改变，使得组织厚度补偿件1140的表面1142可包括比组织厚度补偿件1140的剩余部分高的材料密度，在某些情况下，该更高的材料密度可在冻干后实现。组织厚度补偿件1140可在许多方面类似于别处所述的其他组织厚度补偿件，诸如组织厚度补偿件22020(图9)和/或组织厚度补偿件1120(图26)。表面改性剂1144可用于使用热压制过程修改组织厚度补偿件1140的表面1142，所述热压制过程在许多方面类似于用于修改组织厚度补偿件1104和/或组织厚度补偿件1120的热压制过程，如上所述。例如，组织厚度补偿件1140可至少部分地由包括玻璃化转变温度的材料构成并且可在转变成玻璃态之后被修改。In some cases, it may be desirable to increase the material density of one or more surfaces of the tissue thickness compensator. As shown in FIGS. 29-31 , the tissue thickness compensator 1140 can be modified or altered such that the surface 1142 of the tissue thickness compensator 1140 can comprise a higher material density than the remainder of the tissue thickness compensator 1140, in some cases , this higher material density can be achieved after lyophilization. Tissue thickness compensator 1140 can be similar in many respects to other tissue thickness compensators described elsewhere, such as tissue thickness compensator 22020 (FIG. 9) and/or tissue thickness compensator 1120 (FIG. 26). Surface modifier 1144 may be used to modify surface 1142 of tissue thickness compensator 1140 using a thermal pressing process similar in many respects to the thermal pressing used to modify tissue thickness compensator 1104 and/or tissue thickness compensator 1120 process, as described above. For example, tissue thickness compensator 1140 can be at least partially composed of a material that includes a glass transition temperature and can be modified after transitioning to a glassy state.
如上所述，组织厚度补偿件(诸如组织厚度补偿件1140)可转变成玻璃态，其中该组织厚度补偿件被加热到大于或等于组织厚度补偿件1140的材料组合物的玻璃化转变温度但小于其熔融温度的温度。在组织厚度补偿件1140处于玻璃态时，可抵靠表面1142按压表面改性剂1144。由表面改性剂1144施加的压力可压缩表面1142，从而增加表面1142的材料密度。材料密度的增加可通过以下方式由表面1142保持：使表面1142冷却到低于玻璃化转变温度的温度。As described above, a tissue thickness compensator, such as tissue thickness compensator 1140, can transition to a glassy state, wherein the tissue thickness compensator is heated to a temperature greater than or equal to the glass transition temperature of the material composition of tissue thickness compensator 1140 but less than its melting temperature. Surface modifier 1144 may be pressed against surface 1142 while tissue thickness compensator 1140 is in a glassy state. Pressure applied by surface modifier 1144 may compress surface 1142 , thereby increasing the material density of surface 1142 . The increase in material density may be maintained by surface 1142 by cooling surface 1142 to a temperature below the glass transition temperature.
在某些情况下，由表面改性剂1144抵靠表面1142施加的压力可例如在处于玻璃态的时间期间维持约30秒至约8小时的时间段并且/或者例如在退出玻璃态之后维持约30秒至约8小时的时间段。在至少一个示例中，压力可在处于玻璃态的时间期间维持大约10分钟并且在退出玻璃态之后维持大约10分钟。本公开设想到用于维持由表面改性剂1144抵靠表面1142施加的压力的其他时间段。In some cases, the pressure exerted by surface modifier 1144 against surface 1142 can be maintained, for example, for a period of time from about 30 seconds to about 8 hours during the time in the glass state and/or for a period of about 30 seconds after exiting the glass state, for example. A period of 30 seconds to about 8 hours. In at least one example, the pressure can be maintained for about 10 minutes during the time in the glass state and for about 10 minutes after exiting the glass state. The present disclosure contemplates other periods of time for maintaining the pressure exerted by surface modifier 1144 against surface 1142 .
在一些情况下，风扇可用于在组织厚度补偿件1140与改性剂1144接触时以及/或者在组织厚度补偿件1140已从改性剂1144移除之后在组织厚度补偿件1140上方生成空气流。在一些情况下，制冷过程可用于在组织厚度补偿件1140与改性剂1144接触时以及/或者在组织厚度补偿件1140已从改性剂1144移除之后冷却组织厚度补偿件1140。在组织厚度补偿件1140转变退出玻璃态之后，在各种情况下，表面改性剂1144可与组织厚度补偿件1140脱离接合。在某些情况下，表面改性剂1144可包括加热元件，该加热元件可用于将表面1142的温度增加到大于或等于组织厚度补偿件1140的材料组合物的玻璃化转变温度的温度，如上所述。In some cases, a fan may be used to generate airflow over tissue thickness compensator 1140 while tissue thickness compensator 1140 is in contact with modifier 1144 and/or after tissue thickness compensator 1140 has been removed from modifier 1144 . In some cases, a refrigeration process may be used to cool tissue thickness compensator 1140 while tissue thickness compensator 1140 is in contact with modifier 1144 and/or after tissue thickness compensator 1140 has been removed from modifier 1144 . After the tissue thickness compensator 1140 transitions out of the glassy state, the surface modifier 1144 can be disengaged from the tissue thickness compensator 1140 under various circumstances. In some cases, surface modifier 1144 can include a heating element that can be used to increase the temperature of surface 1142 to a temperature greater than or equal to the glass transition temperature of the material composition of tissue thickness compensator 1140, as described above stated.
再次参见图30，表面改性剂1144可包括平坦的或至少基本上平坦的接触表面1146以用于接触例如表面1142。在其他情况下，接触表面1146可具有各种纹理，诸如可在修改过程期间延伸到组织厚度补偿件1140的表面1142中的突起。在某些情况下，表面改性剂1144可用于在组织厚度补偿件1140转变到玻璃态之前将压力施加到组织厚度补偿件1140的表面1142上。在某些情况下，表面改性剂1144可在组织厚度补偿件1140被加热以达到玻璃态时，在组织厚度补偿件1140处于玻璃态时，以及/或者在组织厚度补偿件1140转变或冷却到玻璃态以下的温度时向表面1142施加压力。在某些情况下，例如在组织厚度补偿件1140的温度逐渐增加以使组织厚度补偿件1140朝玻璃态转变时，由表面改性剂1144施加到表面1142的压力可逐渐朝阈值增加。在某些情况下，在组织厚度补偿件1140退出玻璃态时，在组织厚度补偿件1140退出玻璃态之前，以及/或者在组织厚度补偿件1140退出玻璃态之后，施加到表面1142的压力可被移除、逐渐移除、或至少部分地减小。Referring again to FIG. 30 , surface modifier 1144 may include a planar or at least substantially planar contact surface 1146 for contacting, for example, surface 1142 . In other cases, the contact surface 1146 can have various textures, such as protrusions that can extend into the surface 1142 of the tissue thickness compensator 1140 during the modification procedure. In some cases, surface modifier 1144 can be used to apply pressure to surface 1142 of tissue thickness compensator 1140 before tissue thickness compensator 1140 transitions to the glassy state. In some cases, surface modifier 1144 may be used when tissue thickness compensator 1140 is heated to a glassy state, while tissue thickness compensator 1140 is in a glassy state, and/or when tissue thickness compensator 1140 is transformed or cooled to Pressure is applied to the surface 1142 at temperatures below the glassy state. Under certain circumstances, such as when the temperature of tissue thickness compensator 1140 is gradually increased to transition tissue thickness compensator 1140 toward a glassy state, the pressure applied by surface modifier 1144 to surface 1142 may gradually increase toward a threshold. In some cases, the pressure applied to surface 1142 may be applied to surface 1142 when tissue thickness compensator 1140 exits the glassy state, before tissue thickness compensator 1140 exits the glassy state, and/or after tissue thickness compensator 1140 exits the glassy state. Remove, gradually remove, or at least partially reduce.
在某些情况下，组织厚度补偿件1140可被修改或改变为包括表皮或致密外层。在某些情况下，所得表皮或致密外层可包括纹理，诸如可延伸到组织厚度补偿件1140的表面1142中的突起。在某些情况下，表面改性剂1144的接触表面1146可被加热到大于或等于组织厚度补偿件1140的材料组合物的熔融温度的温度。表面改性剂1144和/或组织厚度补偿件1140可运动以使组织厚度补偿件1140的表面1142与表面改性剂1144的加热接触表面1146接触，从而使表面1142熔融或至少基本上熔融。表面改性剂1144和组织厚度补偿件1140然后可分离以允许修改的表面1142冷却到其熔融温度以下，这可将表皮或致密外层形成到组织厚度补偿件1140上。In some cases, the tissue thickness compensator 1140 may be modified or altered to include an epidermal or dense outer layer. In some cases, the resulting epidermis or dense outer layer can include texture, such as protrusions that can extend into surface 1142 of tissue thickness compensator 1140 . In some cases, contact surface 1146 of surface modifier 1144 may be heated to a temperature greater than or equal to the melting temperature of the material composition of tissue thickness compensator 1140 . Surface modifier 1144 and/or tissue thickness compensator 1140 may be moved to bring surface 1142 of tissue thickness compensator 1140 into contact with heated contact surface 1146 of surface modifier 1144, thereby melting or at least substantially melting surface 1142. Surface modifier 1144 and tissue thickness compensator 1140 may then be separated to allow modified surface 1142 to cool below its melting temperature, which may form a skin or dense outer layer onto tissue thickness compensator 1140 .
在某些情况下，表面改性剂1144的接触表面1146可在与表面1142接触之前被加热。在其他情况下，表面改性剂1144的接触表面1146可在与表面1142接触之后被加热。In some cases, contact surface 1146 of surface modifier 1144 may be heated prior to contacting surface 1142 . In other cases, contact surface 1146 of surface modifier 1144 may be heated after contacting surface 1142 .
在某些情况下，表面改性剂1144的接触表面1146可保持与组织厚度补偿件1140的表面1142接触足以使表面1142流入所需几何形状中的时间段。此类时间段可在例如约30秒至约8小时的范围内，本公开可设想到其他时间段。此类时间段可足以局部影响并且/或者熔融组织厚度补偿件1140的材料并且使其流入新的几何形状中。如本文所述，此类新几何形状可由用于制造组织厚度补偿件1140的工具规定。In some cases, contact surface 1146 of surface modifier 1144 may remain in contact with surface 1142 of tissue thickness compensator 1140 for a period of time sufficient to allow surface 1142 to flow into the desired geometry. Such time periods may range, for example, from about 30 seconds to about 8 hours, with other time periods contemplated by the present disclosure. Such a period of time may be sufficient to locally affect and/or melt the material of the tissue thickness compensator 1140 and cause it to flow into the new geometry. Such new geometries may be dictated by the tooling used to fabricate the tissue thickness compensator 1140 as described herein.
在某些情况下，可在将表面改性剂1144与组织厚度补偿件1140分离之前使组织厚度补偿件1140的表面1142冷却或主动冷却到低于组织厚度补偿件1140的熔融温度的温度。在其他情况下，可在将表面改性剂1144与组织厚度补偿件1140分离之后使组织厚度补偿件1140的表面1142冷却或主动冷却到低于组织厚度补偿件1140的熔融温度的温度。In some cases, surface 1142 of tissue thickness compensator 1140 may be cooled or actively cooled to a temperature below the melting temperature of tissue thickness compensator 1140 prior to separating surface modifier 1144 from tissue thickness compensator 1140 . In other cases, surface 1142 of tissue thickness compensator 1140 may be cooled or actively cooled to a temperature below the melting temperature of tissue thickness compensator 1140 after surface modifier 1144 is separated from tissue thickness compensator 1140 .
对上文进行进一步描述，修改的表面1142可包括密度，例如该密度比组织厚度补偿件1140的剩余部分的密度大约10％、比组织厚度补偿件1140的剩余部分的密度大约20％、比组织厚度补偿件1140的剩余部分的密度大约30％，比组织厚度补偿件1140的剩余部分的密度大约40％、比组织厚度补偿件1140的剩余部分的密度大约50％、比组织厚度补偿件1140的剩余部分的密度大约60％、比组织厚度补偿件1140的剩余部分的密度大约70％、比组织厚度补偿件1140的剩余部分的密度大约80％、比组织厚度补偿件1140的剩余部分的密度大约90％、并且/或者比组织厚度补偿件1140的剩余部分的密度大约100％。在各种情况下，表面1142可包括密度，例如该密度大于组织厚度补偿件1140的剩余部分的密度，并且小于组织厚度补偿件1140的剩余部分的密度的两倍。在各种情况下，修改的表面1142可包括密度，例如该密度大于组织厚度补偿件1140的剩余部分的密度的两倍。Further to the above, the modified surface 1142 can comprise a density, for example, about 10% denser than the remainder of the tissue thickness compensator 1140, about 20% denser than the remainder of the tissue thickness compensator 1140, and about 20% denser than the remaining portion of the tissue thickness compensator 1140, and about 10% denser than the tissue The remaining portion of the thickness compensator 1140 is about 30% denser, about 40% denser than the remaining portion of the tissue thickness compensator 1140, about 50% denser than the remaining portion of the tissue thickness compensator 1140, and about 50% denser than the remaining portion of the tissue thickness compensator 1140. The remaining portion has a density of about 60%, about 70% denser than the remaining portion of the tissue thickness compensator 1140, about 80% denser than the remaining portion of the tissue thickness compensator 1140, about 70% denser than the remaining portion of the tissue thickness compensator 1140 90%, and/or about 100% denser than the remainder of tissue thickness compensator 1140 . In various instances, surface 1142 can comprise a density, eg, greater than the density of the remainder of tissue thickness compensator 1140 and less than twice the density of the remainder of tissue thickness compensator 1140 . In various cases, the modified surface 1142 can comprise a density, eg, greater than twice the density of the remainder of the tissue thickness compensator 1140 .
现在参见图32至图34，组织厚度补偿件1150可被修改为包括可至少部分地延伸穿过组织厚度补偿件1150的多个孔1152。组织厚度补偿件1150可在许多方面类似于本文所述的其他组织厚度补偿件，诸如组织厚度补偿件20220(图6)。如同补偿件20220，补偿件1150可与仓组件20200(图6)一起使用，并且孔1152可在许多方面类似于至少部分地延伸穿过组织厚度补偿件20220的间隙孔20224。例如，如同孔20224，当组织厚度补偿件1150组装有仓组件20200时，孔1152可与对应的钉腿20232(图7)对准，使得钉腿20232可在钉腿20232从未击发构型运动到击发构型时运动穿过组织厚度补偿件1150中的间隙孔1152，如上文更详细地描述。Referring now to FIGS. 32-34 , the tissue thickness compensator 1150 can be modified to include a plurality of apertures 1152 that can extend at least partially through the tissue thickness compensator 1150 . Tissue thickness compensator 1150 can be similar in many respects to other tissue thickness compensators described herein, such as tissue thickness compensator 20220 (FIG. 6). As with compensator 20220 , compensator 1150 can be used with cartridge assembly 20200 ( FIG. 6 ), and aperture 1152 can be similar in many respects to clearance aperture 20224 that extends at least partially through tissue thickness compensator 20220 . For example, like holes 20224, when tissue thickness compensator 1150 is assembled with cartridge assembly 20200, holes 1152 can be aligned with corresponding staple legs 20232 (FIG. 7) such that staple legs 20232 can be moved in the unfired configuration of staple legs 20232 Movement to the fired configuration passes through clearance aperture 1152 in tissue thickness compensator 1150, as described in greater detail above.
对上文进行进一步描述，再次参见图32至图34，组织厚度补偿件1150可使用传统冻干技术和/或任何其他合适的技术来制备。在某些情况下，具有玻璃化转变温度的聚合物(例如聚乳酸(PLA)和/或聚乙醇酸(PGA))可溶解于有机溶剂中以形成溶液，该溶液可被冻干以产生组织厚度补偿件1150。此外，组织厚度补偿件1150可在冻干后使用热压制过程来修改，所述热压制过程在许多方面类似于用于修改组织厚度补偿件1104、组织厚度补偿件1120和/或组织厚度补偿件1140的热压制过程，如上所述。例如，一旦组织厚度补偿件1150转变成玻璃态，组织厚度补偿件1150可被修改为包括孔1152。Referring further to the above, referring again to FIGS. 32-34 , the tissue thickness compensator 1150 may be prepared using conventional freeze-drying techniques and/or any other suitable technique. In some cases, polymers with glass transition temperatures, such as polylactic acid (PLA) and/or polyglycolic acid (PGA), can be dissolved in organic solvents to form solutions that can be lyophilized to produce tissue Thickness compensator 1150 . In addition, tissue thickness compensator 1150 may be modified after lyophilization using a thermal pressing process similar in many respects to that used to modify tissue thickness compensator 1104, tissue thickness compensator 1120, and/or tissue thickness compensator 1140 of the hot pressing process, as described above. For example, tissue thickness compensator 1150 may be modified to include aperture 1152 once tissue thickness compensator 1150 transitions to a glassy state.
如上所述，组织厚度补偿件(诸如组织厚度补偿件1150)可通过在烘箱(未示出)中加热到大于或等于组织厚度补偿件1150的材料组合物的玻璃化转变温度但小于其熔融温度的温度而转变成玻璃态。包括多个柱、榫钉、销和/或突起的模具1154(诸如针1156)可用于通过以下方式形成孔1152：在组织厚度补偿件1150处于玻璃态时将针1156插入组织厚度补偿件1150中。在针1156保持插入组织厚度补偿件1150中时，然后可使组织厚度补偿件1150冷却到低于玻璃化转变温度的温度。在一些情况下，在组织厚度补偿件1150处于玻璃态时，针1156可从组织厚度补偿件1150移除。在一些情况下，风扇可用于在组织厚度补偿件1150与针1156接合时以及/或者在组织厚度补偿件1150已与针1156脱离接合之后在组织厚度补偿件1150上方生成空气流。在一些情况下，制冷过程可用于在组织厚度补偿件1150与针1156接合时以及/或者在组织厚度补偿件1150已与针1156脱离接合之后冷却组织厚度补偿件1150。在各种情况下，针1156可在组织厚度补偿件1150转变退出玻璃态之后被移除。针1156可保持插入组织厚度补偿件1150中持续足以允许组织厚度补偿件1150保持或至少基本上保持限定由针1156占据的孔1152的空间的时间段。As described above, a tissue thickness compensator, such as tissue thickness compensator 1150, can be heated in an oven (not shown) to a temperature greater than or equal to the glass transition temperature of the material composition of tissue thickness compensator 1150 but less than its melting temperature. temperature to transform into a glassy state. Mold 1154, such as needle 1156, comprising a plurality of posts, dowels, pins, and/or protrusions may be used to form aperture 1152 by inserting needle 1156 into tissue thickness compensator 1150 while tissue thickness compensator 1150 is in a glassy state . While needle 1156 remains inserted into tissue thickness compensator 1150, tissue thickness compensator 1150 may then be allowed to cool to a temperature below the glass transition temperature. In some cases, needle 1156 can be removed from tissue thickness compensator 1150 while tissue thickness compensator 1150 is in a glassy state. In some cases, a fan may be used to generate air flow over tissue thickness compensator 1150 while tissue thickness compensator 1150 is engaged with needle 1156 and/or after tissue thickness compensator 1150 has been disengaged from needle 1156 . In some cases, a refrigeration process may be used to cool tissue thickness compensator 1150 while tissue thickness compensator 1150 is engaged with needle 1156 and/or after tissue thickness compensator 1150 has been disengaged from needle 1156 . In various instances, the needle 1156 can be removed after the tissue thickness compensator 1150 transitions out of the glassy state. Needle 1156 may remain inserted into tissue thickness compensator 1150 for a period of time sufficient to allow tissue thickness compensator 1150 to maintain, or at least substantially maintain, the space defining aperture 1152 occupied by needle 1156 .
在某些示例中，针1156可例如在处于玻璃态的时间期间保持插入约30秒至约8小时的时间段并且/或者例如在退出玻璃态之后保持插入约30秒至约8小时的时间段。在至少一个示例中，针1156可在处于玻璃态的时间期间保持插入大约10分钟并且在退出玻璃态之后保持插入大约10分钟。本公开设想到用于维持针1156插入组织厚度补偿件1150中的其他时间段。In some examples, the needle 1156 can remain inserted for a period of time from about 30 seconds to about 8 hours, such as during the time in the glass state and/or for a period of time from about 30 seconds to about 8 hours after exiting the glass state, for example. . In at least one example, the needle 1156 can remain inserted for about 10 minutes during the time in the glass state and for about 10 minutes after exiting the glass state. The present disclosure contemplates other periods of time for maintaining needle 1156 insertion into tissue thickness compensator 1150 .
在某些情况下，在组织厚度补偿件1150转变退出玻璃态之前，针1156可从组织厚度补偿件1150移除。在其他情况下，针1156可随着时间推移逐渐移除。例如，在组织厚度补偿件1150转变退出玻璃态之前，针1156可从组织厚度补偿件1150部分地移除。在组织厚度补偿件1150转变退出玻璃态之后，针1156然后可从组织厚度补偿件1150完全移除。读者将理解，针1156插入组织厚度补偿件1150中的深度越大，组织厚度补偿件1150中可形成的对应孔1152的深度就越大。In some cases, needle 1156 may be removed from tissue thickness compensator 1150 before tissue thickness compensator 1150 transitions out of the glass state. In other cases, needle 1156 may be gradually removed over time. For example, needle 1156 may be partially removed from tissue thickness compensator 1150 before tissue thickness compensator 1150 transitions out of the glass state. After the tissue thickness compensator 1150 transitions out of the glassy state, the needle 1156 can then be completely removed from the tissue thickness compensator 1150 . The reader will understand that the greater the depth to which the needle 1156 is inserted into the tissue thickness compensator 1150 , the greater the depth to which a corresponding aperture 1152 may be formed in the tissue thickness compensator 1150 .
再次参见图32至图34，在某些情况下，针1156可被加热到大于或等于组织厚度补偿件1150的材料组合物的熔融温度的温度。另外，针1156可被插入组织厚度补偿件1150中以通过熔融或至少部分地熔融穿过组织厚度补偿件1150的接收针1156的区域而形成孔1152。在各种情况下，针1156可在插入组织厚度补偿件1150中之前被加热。在各种情况下，针1156可在插入组织厚度补偿件1150中之后被加热。在各种情况下，针1156可随着针1156被插入组织厚度补偿件1150中而逐渐加热。Referring again to FIGS. 32-34 , in some cases, needle 1156 may be heated to a temperature greater than or equal to the melting temperature of the material composition of tissue thickness compensator 1150 . Additionally, needle 1156 may be inserted into tissue thickness compensator 1150 to form aperture 1152 by melting or at least partially melting through the region of tissue thickness compensator 1150 that receives needle 1156 . In various circumstances, needle 1156 can be heated prior to insertion into tissue thickness compensator 1150 . In various circumstances, needle 1156 may be heated after insertion into tissue thickness compensator 1150 . In various circumstances, the needle 1156 can be gradually heated as the needle 1156 is inserted into the tissue thickness compensator 1150 .
在某些情况下，针1156可保持定位在组织厚度补偿件1150内持续足以允许组织厚度补偿件1150的熔融材料流入所需几何形状中的时间段。此类时间段可在例如约30秒至约8小时的范围内，本公开可设想到其他时间段。此类时间段可足以局部影响并且/或者熔融组织厚度补偿件1150的材料并且使其流入新的几何形状中。如本文所述，此类新几何形状可由用于制造组织厚度补偿件1150的工具规定。In some cases, needle 1156 may remain positioned within tissue thickness compensator 1150 for a period of time sufficient to allow molten material of tissue thickness compensator 1150 to flow into the desired geometry. Such time periods may range, for example, from about 30 seconds to about 8 hours, with other time periods contemplated by the present disclosure. Such a period of time may be sufficient to locally affect and/or melt the material of the tissue thickness compensator 1150 and cause it to flow into the new geometry. Such new geometries may be dictated by the tooling used to fabricate the tissue thickness compensator 1150 as described herein.
在某些情况下，可在将针1156与组织厚度补偿件1150分离之前使组织厚度补偿件1150冷却或主动冷却到低于组织厚度补偿件1150的熔融温度的温度。在其他情况下，可在将针1156与组织厚度补偿件1150分离之后使组织厚度补偿件1150冷却或主动冷却到低于组织厚度补偿件1150的熔融温度的温度。In some cases, the tissue thickness compensator 1150 may be cooled or actively cooled to a temperature below the melting temperature of the tissue thickness compensator 1150 prior to separating the needle 1156 from the tissue thickness compensator 1150 . In other cases, tissue thickness compensator 1150 may be cooled or actively cooled to a temperature below the melting temperature of tissue thickness compensator 1150 after needle 1156 is separated from tissue thickness compensator 1150 .
再次参见图32至图34，针1156可以被布置成沿模具1154的长度纵向延伸的排，该排可对应于钉仓(诸如钉仓组件20200(图6))中的钉排。例如，如图33所示，针1156可以布置成六排，其可被构造成能够形成六排孔1152，该六排孔可被构造成能够接收六排钉20230(图7)。在某些情况下，如图33所示，针1156的排可以布置成两组，所述两组间隔开并且被构造成能够接收在组织厚度补偿件1150的两部分1158和1160中，从而形成由中间部分1162分离的两组孔1152。当组织厚度补偿件1150组装有钉仓组件20200时，中间部分1162可至少部分地定位在仓刀狭槽22015(图6)上方。在使用中，击发构件10052(图10)可朝远侧推进以推动钉腿20232(图8)穿过部分1158和1160内的孔1152并且推进切割部分10053(图10)以横切中间部分1162并且分离部分1158和1160。Referring again to FIGS. 32-34 , needles 1156 can be arranged in rows extending longitudinally along the length of die 1154 , which rows can correspond to rows of staples in a staple cartridge, such as staple cartridge assembly 20200 ( FIG. 6 ). For example, as shown in FIG. 33, the needles 1156 can be arranged in six rows, which can be configured to form six rows of holes 1152, which can be configured to receive six rows of staples 20230 (FIG. 7). In some cases, as shown in FIG. 33 , the rows of needles 1156 may be arranged in two sets spaced apart and configured to be received in two portions 1158 and 1160 of tissue thickness compensator 1150 to form Two sets of holes 1152 separated by middle section 1162 . Intermediate portion 1162 can be positioned at least partially over cartridge knife slot 22015 ( FIG. 6 ) when tissue thickness compensator 1150 is assembled with staple cartridge assembly 20200 . In use, firing member 10052 ( FIG. 10 ) can be advanced distally to push staple legs 20232 ( FIG. 8 ) through holes 1152 in portions 1158 and 1160 and to advance cutting portion 10053 ( FIG. 10 ) to transect intermediate portion 1162 And sections 1158 and 1160 are separated.
再次参见图32至图34，孔1152可被构造成能够在组织厚度补偿件1150内延伸并且终止在组织厚度补偿件1150内的一定深度处。孔1152可包括均匀的深度，如图34所示。在其他情况下，孔1152可包括不同深度(未示出)。例如，第一排孔1152可包括第一深度，并且第二排孔1152可包括不同于第一深度的第二深度，而第三排孔1152可包括不同于第一深度和第二深度的第三深度。孔1152的深度可至少部分地通过对应针1156的高度来确定。例如，包括第一高度的第一排针1156和包括大于第一高度的第二高度的第二排针1156可形成包括第一深度的第一排孔1152和包括大于第一深度的第二深度的第二排孔1152。Referring again to FIGS. 32-34 , aperture 1152 can be configured to extend within tissue thickness compensator 1150 and terminate at a depth within tissue thickness compensator 1150 . Holes 1152 may comprise a uniform depth, as shown in FIG. 34 . In other cases, holes 1152 may include different depths (not shown). For example, a first row of holes 1152 can include a first depth, and a second row of holes 1152 can include a second depth that is different from the first depth, and a third row of holes 1152 can include a second depth that is different than the first and second depths. Three depths. The depth of the hole 1152 can be determined at least in part by the height of the corresponding needle 1156 . For example, a first row of pins 1156 including a first height and a second row of pins 1156 including a second height greater than the first height may form a first row of holes 1152 including a first depth and a second depth greater than the first depth. The second row of holes 1152.
再次参见图32至图34，针1156可被构造成能够将用于孔1152的轨线限定在组织厚度补偿件1150内。在某些情况下，针1156可沿垂直于以及/或者基本上垂直于模具1154的模具表面1164的轴线延伸，如图33所示。将针1156插入组织厚度补偿件1150中同时维持模具表面1164和组织厚度补偿件1150的表面1166之间的平行关系可导致相对于组织厚度补偿件1150的表面1166限定用于孔1152的垂直和/或基本上垂直的轨线，如图34所示。在其他情况下，针1156可以斜角(未示出)从模具表面1164延伸并且/或者针1156到组织厚度补偿件1150中的插入轨线可成角度，使得针1156可相对于组织厚度补偿件1150的表面1166限定用于孔1152的非垂直轨线。在某些情况下，一组针1156可彼此平行并且/或者基本上彼此平行，如图33所示，从而导致一组孔1152可彼此平行并且/或者基本上彼此平行，如图24所示。在其他情况下，虽然未示出，但一组非平行的针可从模具表面1164延伸并且可在插入组织厚度补偿件1150中时产生非平行的孔。在一些情况下，针1156可被构造成能够在组织厚度补偿件1150内形成孔，该组织厚度补偿件可包括部分弯曲的轨线和/或部分线性的轨线。例如，针1156可以部分弯曲的轨线从模具表面1164延伸并且可被插入组织厚度补偿件1150中以利用对应的部分弯曲的轨线在组织厚度补偿件1150内形成孔。Referring again to FIGS. 32-34 , needle 1156 can be configured to define a trajectory for aperture 1152 within tissue thickness compensator 1150 . In some cases, the needles 1156 can extend along an axis that is perpendicular and/or substantially perpendicular to the mold surface 1164 of the mold 1154, as shown in FIG. 33 . Inserting needle 1156 into tissue thickness compensator 1150 while maintaining a parallel relationship between mold surface 1164 and surface 1166 of tissue thickness compensator 1150 may result in defining a perpendicular and/or or substantially vertical trajectories, as shown in Figure 34. In other cases, the needle 1156 can extend from the mold surface 1164 at a bevel (not shown) and/or the insertion trajectory of the needle 1156 into the tissue thickness compensator 1150 can be angled such that the needle 1156 can be positioned relative to the tissue thickness compensator 1150. Surface 1166 of 1150 defines a non-perpendicular trajectory for aperture 1152 . In some cases, a set of needles 1156 can be parallel and/or substantially parallel to each other, as shown in FIG. 33 , resulting in a set of holes 1152 can be parallel and/or substantially parallel to each other, as shown in FIG. 24 . In other cases, although not shown, a set of non-parallel needles may extend from mold surface 1164 and may create non-parallel holes when inserted into tissue thickness compensator 1150 . In some cases, needle 1156 can be configured to form a hole within tissue thickness compensator 1150, which can include a partially curved trajectory and/or a partially linear trajectory. For example, needle 1156 may extend from mold surface 1164 with a partially curved trajectory and may be inserted into tissue thickness compensator 1150 to form a hole within tissue thickness compensator 1150 with a corresponding partially curved trajectory.
再次参见图32至图34，针1156中的一些或全部可包括钝的远侧端部1168，如图33所示。在其他情况下，针1156中的一些或全部可包括锐利的远侧端部(未示出)。针1156中的一些或全部可包括圆柱形或至少基本上圆柱形的形状，例如，如图33所示。本公开还可设想到其他形状。在各种情况下，从模具表面1164延伸的针1156中的一个或多个可能不能够插入穿过组织厚度补偿件1150的整个厚度。在某些情况下，从模具表面1164延伸的针1156中的一个或多个可能能够插入穿过组织厚度补偿件1150的整个厚度以形成延伸穿过组织厚度补偿件1150的整个厚度的开口和/或孔。在某些情况下，从模具表面1164延伸的针1156中的一个或多个可插入穿过组织厚度补偿件1150的第一侧并且穿过例如组织厚度补偿件1150的可与第一侧相对的第二侧离开。在某些情况下，针1156中的一个或多个可包括大于组织厚度补偿件1150的整个厚度的长度以有利于将一个或多个针1156插入穿过组织厚度补偿件1150的整个厚度。Referring again to FIGS. 32-34 , some or all of the needles 1156 may include blunt distal ends 1168 , as shown in FIG. 33 . In other cases, some or all of needles 1156 may include sharpened distal ends (not shown). Some or all of the needles 1156 may comprise a cylindrical or at least substantially cylindrical shape, eg, as shown in FIG. 33 . Other shapes are also contemplated by this disclosure. In various circumstances, one or more of the needles 1156 extending from the mold surface 1164 may not be able to be inserted through the entire thickness of the tissue thickness compensator 1150 . In some cases, one or more of the needles 1156 extending from the mold surface 1164 may be capable of being inserted through the entire thickness of the tissue thickness compensator 1150 to form an opening extending through the entire thickness of the tissue thickness compensator 1150 and/or or hole. In some cases, one or more of needles 1156 extending from mold surface 1164 can be inserted through a first side of tissue thickness compensator 1150 and through, for example, a side of tissue thickness compensator 1150 that can be opposite the first side. Second side left. In some cases, one or more of needles 1156 can include a length greater than the entire thickness of tissue thickness compensator 1150 to facilitate insertion of one or more needles 1156 through the entire thickness of tissue thickness compensator 1150 .
现在参见图35至图37，可能需要重新设定组织厚度补偿件的尺寸。例如，组织厚度补偿件的一个或多个尺寸可被调整为对应于钉仓的尺寸以便在组织厚度补偿件组装有钉仓时向钉仓提供更好的配合。在某些情况下，组织厚度补偿件1170可通过将其高度从如图35所示的第一高度H1改变为如图36所示的第二高度H2来重新设定尺寸。组织厚度补偿件1170可在许多方面类似于本文所述的其他组织厚度补偿件，诸如组织厚度补偿件22020(图9)、组织厚度补偿件1140(图29)和/或组织厚度补偿件1150(图32)。例如，如同补偿件22020，补偿件1170可与端部执行器22090(图9)一起使用。Referring now to FIGS. 35-37 , it may be necessary to resize the tissue thickness compensator. For example, one or more dimensions of the tissue thickness compensator can be adjusted to correspond to the dimensions of the staple cartridge to provide a better fit to the staple cartridge when the tissue thickness compensator is assembled with the staple cartridge. In some cases, the tissue thickness compensator 1170 can be resized by changing its height from a first height H1 as shown in FIG. 35 to a second height H2 as shown in FIG. 36 . Tissue thickness compensator 1170 can be similar in many respects to other tissue thickness compensators described herein, such as tissue thickness compensator 22020 ( FIG. 9 ), tissue thickness compensator 1140 ( FIG. 29 ), and/or tissue thickness compensator 1150 ( Figure 32). For example, like compensator 22020, compensator 1170 may be used with end effector 22090 (FIG. 9).
在各种情况下，再次参见图35至图37，组织厚度补偿件1170可使用传统冻干技术和/或任何其他合适的技术来制备。在某些情况下，组织厚度补偿件1170可使用例如热压制过程和模具1172来重新设定尺寸，如图37所示。模具1172可包括被构造成能够接收组织厚度补偿件1170的接收器1174以及能够部分地插入接收器1174中的调节构件1176。当组织厚度补偿件1170转变成玻璃态时，组织厚度补偿件1170可被重新设定尺寸。在一个实施方案中，组织厚度补偿件1170可在烘箱(未示出)中加热到大于或等于组织厚度补偿件1170的材料组合物的玻璃化转变温度但小于其熔融温度的温度。在另一个实施方案中，接收器1174和/或调节构件1176可包括用于将组织厚度补偿件1170转变到玻璃态的加热元件。调节构件1176然后可被插入接收器1174中距离H3，例如如图37所示，从而压缩组织厚度补偿件1170并且将其高度从第一高度H1减小到第二高度H2。在一些情况下，可在组织厚度补偿件1170进入玻璃态之前或者正好在组织厚度补偿件1170进入玻璃态时将调节构件1176插入接收器1174中。调节构件1176可抵靠组织厚度补偿件1170保持以压缩组织厚度补偿件1170持续足以允许组织厚度补偿件1170保持或至少基本上保持第二高度H2的时间段，如图36所示。在处于来自调节构件1176的压缩下时，然后可使组织厚度补偿件1170冷却到低于玻璃化转变温度的温度。在组织厚度补偿件1170转变退出玻璃态之后，调节构件1176可回缩。在一些情况下，在组织厚度补偿件1170退出玻璃态之前，调节构件1176可回缩。在某些情况下，上述重定尺寸过程可用于改变组织厚度补偿件1170的另一个尺寸，诸如组织厚度补偿件1170的长度或宽度。在一些情况下，这些尺寸可以同时修改或按顺序修改。In various cases, referring again to FIGS. 35-37 , the tissue thickness compensator 1170 can be prepared using conventional freeze-drying techniques and/or any other suitable technique. In some cases, the tissue thickness compensator 1170 can be resized using, for example, a hot pressing process and mold 1172, as shown in FIG. Mold 1172 can include a receptacle 1174 configured to receive tissue thickness compensator 1170 and an adjustment member 1176 that can be partially inserted into receptacle 1174 . When the tissue thickness compensator 1170 transitions to the glassy state, the tissue thickness compensator 1170 can be resized. In one embodiment, tissue thickness compensator 1170 may be heated in an oven (not shown) to a temperature greater than or equal to the glass transition temperature of the material composition of tissue thickness compensator 1170 but less than its melting temperature. In another embodiment, receiver 1174 and/or adjustment member 1176 may include a heating element for transitioning tissue thickness compensator 1170 to a glassy state. Adjustment member 1176 may then be inserted into receiver 1174 a distance H3, eg, as shown in FIG. 37, thereby compressing tissue thickness compensator 1170 and reducing its height from first height H1 to second height H2. In some cases, adjustment member 1176 may be inserted into receptacle 1174 before tissue thickness compensator 1170 enters the vitreous state or just as tissue thickness compensator 1170 enters the vitreous state. Adjustment member 1176 may be held against tissue thickness compensator 1170 to compress tissue thickness compensator 1170 for a period of time sufficient to allow tissue thickness compensator 1170 to maintain, or at least substantially maintain, second height H2, as shown in FIG. 36 . While under compression from adjustment member 1176, tissue thickness compensator 1170 may then be allowed to cool to a temperature below the glass transition temperature. After the tissue thickness compensator 1170 transitions out of the glass state, the adjustment member 1176 can be retracted. In some cases, adjustment member 1176 can be retracted before tissue thickness compensator 1170 exits the glassy state. In some cases, the resizing process described above may be used to change another dimension of the tissue thickness compensator 1170 , such as the length or width of the tissue thickness compensator 1170 . In some cases, these dimensions may be modified simultaneously or sequentially.
在某些示例中，来自调节构件1176的压缩可例如在处于玻璃态的时间期间维持约30秒至约8小时的时间段并且/或者例如在退出玻璃态之后维持约30秒至约8小时的时间段。在至少一个示例中，来自调节构件1176的压缩可在处于玻璃态的时间期间维持大约10分钟并且在退出玻璃态之后维持大约10分钟。本公开可设想到用于维持由调节构件1176抵靠组织厚度补偿件1170施加的压缩的时间段。In certain examples, compression from adjustment member 1176 may be maintained, for example, for a period of about 30 seconds to about 8 hours during the time in the glass state and/or for a period of about 30 seconds to about 8 hours after exiting the glass state, for example. period. In at least one example, the compression from the adjustment member 1176 can be maintained for about 10 minutes during the time in the glass state and for about 10 minutes after exiting the glass state. The present disclosure contemplates a period of time for maintaining the compression applied by adjustment member 1176 against tissue thickness compensator 1170 .
在某些情况下，调节构件1176可用于在组织厚度补偿件1170转变到玻璃态之前将压力施加到组织厚度补偿件1170上。在某些情况下，调节构件1176可在组织厚度补偿件1170被加热以达到玻璃态时，在组织厚度补偿件1170处于玻璃态时，以及/或者在组织厚度补偿件1170转变或冷却到玻璃态以下的温度时向组织厚度补偿件1170施加压力。在某些情况下，例如在组织厚度补偿件1170的温度逐渐朝玻璃态转变时，施加到组织厚度补偿件1170的压力可逐渐朝阈值增加。在某些情况下，在组织厚度补偿件1170退出玻璃态时，在组织厚度补偿件1170退出玻璃态之前，以及/或者在组织厚度补偿件1170退出玻璃态之后，施加到组织厚度补偿件1170的压力可被移除、逐渐移除、或至少部分地减小。In some cases, adjustment member 1176 can be used to apply pressure to tissue thickness compensator 1170 before tissue thickness compensator 1170 transitions to the glassy state. In some cases, adjustment member 1176 may be used when tissue thickness compensator 1170 is heated to a glassy state, while tissue thickness compensator 1170 is in a glassy state, and/or when tissue thickness compensator 1170 transitions or cools to a glassy state Pressure is applied to the tissue thickness compensator 1170 at temperatures below. In some cases, such as when the temperature of the tissue thickness compensator 1170 gradually transitions towards a glassy state, the pressure applied to the tissue thickness compensator 1170 may gradually increase towards a threshold. In some cases, the tissue thickness compensator 1170 is applied to the tissue thickness compensator 1170 when the tissue thickness compensator 1170 exits the glass state, before the tissue thickness compensator 1170 exits the glass state, and/or after the tissue thickness compensator 1170 exits the glass state. Pressure may be removed, gradually removed, or at least partially reduced.
读者将理解，用于上述修改过程中的不同模具(诸如模具1144、1154和/或1172)是示例性示例。其他模具设计和构型也可用于以多种方式操纵组织厚度补偿件。此外，操纵组织厚度补偿件所涉及的力不需要仅仅是压缩力。例如，拉力也可用于以与上文所述的那些方式类似的方式修改组织厚度补偿件、重新设定组织厚度补偿件的形状和/或尺寸。例如，也可使用拉力来拉伸组织厚度补偿件1170以将其高度从第一高度H1(图35)减小到第二高度H2(图36)，例如，使用在许多方面类似于上述修改过程的修改过程。在某些情况下，拉力和压缩力的组合可用于在修改过程期间操纵组织厚度补偿件。The reader will appreciate that the different molds used in the modification process described above, such as molds 1144, 1154, and/or 1172, are illustrative examples. Other mold designs and configurations can also be used to manipulate the tissue thickness compensator in various ways. Furthermore, the forces involved in manipulating the tissue thickness compensator need not be solely compressive. For example, tension may also be used to modify, reshape and/or size the tissue thickness compensator in a manner similar to those described above. For example, tensile force can also be used to stretch the tissue thickness compensator 1170 to reduce its height from a first height H1 (FIG. 35) to a second height H2 (FIG. 36), e.g., using a modified process similar in many respects to that described above. modification process. In some cases, a combination of tensile and compressive forces can be used to manipulate the tissue thickness compensator during the modification procedure.
再次参见图35至图37，可能需要修改组织厚度补偿件的孔隙度以在外科手术中使用。组织厚度补偿件可包括例如多孔的开孔泡沫和/或多孔的闭孔泡沫。传统冻干技术可对组织厚度补偿件的孔隙度提供一定的控制，但此类控制可能不易于重复并且可能需要不可通过传统冻干技术获得的附加的精细调节。如图35至图37所示，可使用例如上述修改过程使组织厚度补偿件1170的高度从第一高度H1(图35)变为第二高度H2(图36)。另外，也可使用相同和/或相似的修改过程来修改组织厚度补偿件1170的孔隙度。例如，组织厚度补偿件1170可在修改过程之前具有第一孔隙度(图35)，并且在完成修改过程之后具有第二孔隙度(图36)，如上所述。孔隙度的改变可至少部分地归因于在上述修改过程期间由调节构件1176施加到组织厚度补偿件1170的压缩力和/或能量。Referring again to FIGS. 35-37 , it may be desirable to modify the porosity of the tissue thickness compensator for use in a surgical procedure. The tissue thickness compensator may comprise, for example, porous open-cell foam and/or porous closed-cell foam. Conventional lyophilization techniques may provide some control over the porosity of the tissue thickness compensator, but such control may not be readily repeatable and may require additional fine-tuning not available through conventional lyophilization techniques. As shown in FIGS. 35-37 , the height of the tissue thickness compensator 1170 can be changed from a first height H1 ( FIG. 35 ) to a second height H2 ( FIG. 36 ) using, for example, the modification process described above. Additionally, the porosity of the tissue thickness compensator 1170 may also be modified using the same and/or similar modification process. For example, the tissue thickness compensator 1170 may have a first porosity (FIG. 35) prior to the modification process and a second porosity (FIG. 36) after completion of the modification process, as described above. Changes in porosity may be attributable, at least in part, to compressive forces and/or energy applied to tissue thickness compensator 1170 by adjustment member 1176 during the modification process described above.
对上文进行进一步描述，组织厚度补偿件1170可包括多个孔隙1180。例如，作为上述修改过程的结果，孔隙1180中的一些或全部可在位置、尺寸和/或形状方面有所改变。例如，孔隙1180中的一个或多个可在修改过程之前包括球形或基本上球形的形状，作为修改过程的结果，该形状可被改变为椭圆形或基本上椭圆形的形状。在至少一个示例中，孔隙1180中的一个或多个可在修改过程之前包括第一尺寸并且作为修改过程的结果包括不同于第一尺寸的第二尺寸。在某些情况下，如下文更详细地描述，孔隙度改变可局限于组织厚度补偿件1170的一个或多个区域或区。Further to the above, the tissue thickness compensator 1170 may include a plurality of apertures 1180 . For example, some or all of apertures 1180 may change in location, size and/or shape as a result of the modification process described above. For example, one or more of apertures 1180 may comprise a spherical or substantially spherical shape prior to the modification process, which shape may be changed to an elliptical or substantially elliptical shape as a result of the modification process. In at least one example, one or more of apertures 1180 may include a first size prior to the modification process and include a second size different from the first size as a result of the modification process. In some cases, as described in more detail below, the change in porosity may be localized to one or more regions or regions of the tissue thickness compensator 1170 .
此外，在某些情况下，组织厚度补偿件1170的孔隙度的改变可伴随着组织厚度补偿件1170的密度的改变。换句话讲，在调节构件1176抵靠组织厚度补偿件1170推进时，压缩力可减小组织厚度补偿件1170所占据的空间，从而导致材料和/或孔隙重新分布，这可引起组织厚度补偿件1170的密度的增加和/或其孔隙度的减小。在某些情况下，如下文更详细地描述，密度改变可局限于组织厚度补偿件1170的一个或多个区域或区。Additionally, in some cases, changes in the porosity of the tissue thickness compensator 1170 may be accompanied by changes in the density of the tissue thickness compensator 1170 . In other words, as adjustment member 1176 is advanced against tissue thickness compensator 1170, the compressive force can reduce the space occupied by tissue thickness compensator 1170, thereby causing material and/or porosity to redistribute, which can cause tissue thickness compensation An increase in the density of member 1170 and/or a decrease in its porosity. In some cases, as described in more detail below, the change in density may be localized to one or more regions or regions of the tissue thickness compensator 1170 .
对上文进行进一步描述，组织厚度补偿件1170的孔隙度和/或密度的改变可引起组织厚度补偿件1170的弹性比率的改变。当组织厚度补偿件抵靠由钉诸如钉20230(图8)捕获的组织部署时，组织厚度补偿件的弹性比率可影响其补偿组织厚度的能力，如上文更详细地描述。此外，组织厚度补偿件的弹性比率也可影响其抵靠由钉用组织厚度补偿件捕获的组织施加压力的能力。换句话讲，组织厚度补偿件的弹性比率的变化可改变由组织厚度补偿件抵靠由钉捕获的组织所施加的压力。由于不同组织类型可对一定压力作出更积极的响应，所以对组织厚度补偿件的弹性比率的精细控制可为有利的。Further to the above, changes in the porosity and/or density of the tissue thickness compensator 1170 may result in changes in the elasticity ratio of the tissue thickness compensator 1170 . When the tissue thickness compensator is deployed against tissue captured by staples, such as staples 20230 (FIG. 8), the elasticity ratio of the tissue thickness compensator can affect its ability to compensate for tissue thickness, as described in more detail above. Additionally, the elasticity ratio of the tissue thickness compensator may also affect its ability to exert pressure against tissue captured by the staple tissue thickness compensator. In other words, changes in the elasticity ratio of the tissue thickness compensator can alter the pressure exerted by the tissue thickness compensator against tissue captured by the staples. Since different tissue types may respond more positively to certain pressures, fine control over the elastic ratio of the tissue thickness compensator may be beneficial.
如图35至图37所示，组织厚度补偿件1170可包括第一弹性比率(图35)，该第一弹性比率可使用上述修改过程改变或修改为不同于第一弹性比率的第二弹性比率(图36)。例如，如上所述，在组织厚度补偿件1170处于玻璃态时，调节构件1176可抵靠组织厚度补偿件1170推进。作为响应，组织厚度补偿件1170可被压缩，这导致组织厚度补偿件1170的弹性比率的改变。调节构件1176可保持在推进位置中持续足以允许组织厚度补偿件1170保持或至少基本上保持弹性比率的变化的时间段。另外，可使组织厚度补偿件1170冷却到其材料组合物的玻璃化转变温度以下，同时维持由调节构件1176抵靠组织厚度补偿件1170施加的压力。As shown in FIGS. 35-37 , the tissue thickness compensator 1170 can include a first elastic ratio ( FIG. 35 ) that can be changed or modified to a second elastic ratio different from the first elastic ratio using the modification process described above. (Figure 36). For example, as described above, adjustment member 1176 may be advanced against tissue thickness compensator 1170 while tissue thickness compensator 1170 is in a glassy state. In response, tissue thickness compensator 1170 may be compressed, which results in a change in the elastic ratio of tissue thickness compensator 1170 . Adjustment member 1176 can remain in the advanced position for a period of time sufficient to allow tissue thickness compensator 1170 to maintain, or at least substantially maintain, the change in elastic ratio. Additionally, the tissue thickness compensator 1170 can be cooled below the glass transition temperature of its material composition while maintaining the pressure exerted by the adjustment member 1176 against the tissue thickness compensator 1170 .
在某些情况下，调节构件1176可例如在处于玻璃态的时间期间抵靠组织厚度补偿件1170维持在推进位置中持续约30秒至约8小时的时间段并且/或者例如在退出玻璃态之后持续约30秒至约8小时的时间段。在至少一个示例中，调节构件1176可例如在处于玻璃态的时间期间抵靠组织厚度补偿件1170维持在推进位置中持续大约10分钟并且在退出玻璃态之后持续大约10分钟。本公开可设想到用于将调节构件1176抵靠组织厚度补偿件1170维持在推进位置中的其他时间段。In some cases, the adjustment member 1176 can be maintained in the advanced position against the tissue thickness compensator 1170 for a period of time ranging from about 30 seconds to about 8 hours, for example, during the time in the vitreous state and/or after exiting the vitreous state, for example. For a period of time ranging from about 30 seconds to about 8 hours. In at least one example, the adjustment member 1176 can be maintained in the advanced position against the tissue thickness compensator 1170 for about 10 minutes during the time in the vitreous state and for about 10 minutes after exiting the vitreous state, for example. Other periods of time for maintaining adjustment member 1176 in the advanced position against tissue thickness compensator 1170 are contemplated by the present disclosure.
在某些情况下，调节构件1176可用于在组织厚度补偿件1170转变到玻璃态之前将压力施加到组织厚度补偿件1170上以改变组织厚度补偿件1170的弹性比率。在某些情况下，调节构件1176可在组织厚度补偿件1170被加热以达到玻璃态时，在组织厚度补偿件1170处于玻璃态时，以及/或者在组织厚度补偿件1170转变或冷却到玻璃态以下的温度时向组织厚度补偿件1170施加压力。在某些情况下，例如在组织厚度补偿件1170的温度逐渐增加以使组织厚度补偿件1170朝玻璃态转变时，施加到组织厚度补偿件1170的压力可逐渐朝阈值增加。在某些情况下，在组织厚度补偿件1170退出玻璃态时，在组织厚度补偿件1170退出玻璃态之前，以及/或者在组织厚度补偿件1170退出玻璃态之后，施加到组织厚度补偿件1170的压力可被移除、逐渐移除、或至少部分地减小。In some cases, adjustment member 1176 can be used to apply pressure to tissue thickness compensator 1170 to change the elastic ratio of tissue thickness compensator 1170 before tissue thickness compensator 1170 transitions to the glassy state. In some cases, adjustment member 1176 may be used when tissue thickness compensator 1170 is heated to a glassy state, while tissue thickness compensator 1170 is in a glassy state, and/or when tissue thickness compensator 1170 transitions or cools to a glassy state Pressure is applied to the tissue thickness compensator 1170 at temperatures below. In some cases, such as when the temperature of the tissue thickness compensator 1170 is gradually increased to transition the tissue thickness compensator 1170 toward a glassy state, the pressure applied to the tissue thickness compensator 1170 may gradually increase toward a threshold. In some cases, the tissue thickness compensator 1170 is applied to the tissue thickness compensator 1170 when the tissue thickness compensator 1170 exits the glass state, before the tissue thickness compensator 1170 exits the glass state, and/or after the tissue thickness compensator 1170 exits the glass state. Pressure may be removed, gradually removed, or at least partially reduced.
再次参见图35至图40，组织厚度补偿件1170可使用传统冻干技术和/或任何其他合适的技术以自然的弹性比率来制造。如上所述，组织厚度补偿件1170的弹性比率可影响其抵靠由钉用组织厚度补偿件1170捕获的组织施加压力的能力。上述修改过程可用于调节组织厚度补偿件1170的自然弹性比率以调节其抵靠由钉用组织厚度补偿件1170捕获的组织施加压力的能力。在某些情况下，组织厚度补偿件1170的自然弹性比率可从点A(图40)处的第一弹性比率增加到第二弹性比率，该第二弹性比率包括并且最多至点B(图40)处的最大弹性比率。在某些情况下，组织厚度补偿件1170的弹性比率的此类增加可通过以下方式实现：在组织厚度补偿件1170处于玻璃态时，使用调节构件1176向组织厚度补偿件1170施加压缩力，如上述修改过程中所解释的。如图40所示，点B代表组织厚度补偿件1170的最大弹性产率。因此，由调节构件1176在点B处施加到组织厚度补偿件1170的超过阈值压缩的任何附加压缩可导致被修改的组织厚度补偿件1170的弹性比率的减小。例如，如图40所示，在点C处的弹性比率小于在点B处的弹性比率，即使由调节构件1176在点C处施加到组织厚度补偿件1170的压缩力大于在点B处施加的压缩力。Referring again to FIGS. 35-40 , the tissue thickness compensator 1170 may be manufactured at a natural elastic ratio using conventional freeze-drying techniques and/or any other suitable technique. As noted above, the elasticity ratio of the tissue thickness compensator 1170 can affect its ability to apply pressure against tissue captured by the stapled tissue thickness compensator 1170 . The modification process described above can be used to adjust the natural elastic ratio of the tissue thickness compensator 1170 to adjust its ability to apply pressure against tissue captured by the stapled tissue thickness compensator 1170 . In some cases, the natural elastic rate of the tissue thickness compensator 1170 may increase from a first elastic rate at point A ( FIG. 40 ) to a second elastic rate including and up to point B ( FIG. 40 ). ) at the maximum elastic ratio. In some cases, such an increase in the elastic ratio of tissue thickness compensator 1170 may be achieved by applying a compressive force to tissue thickness compensator 1170 using adjustment member 1176 while tissue thickness compensator 1170 is in the glassy state, such as As explained in the modification procedure above. As shown in FIG. 40 , point B represents the maximum elastic yield of the tissue thickness compensator 1170 . Accordingly, any additional compression applied to tissue thickness compensator 1170 at point B by adjustment member 1176 beyond the threshold compression may result in a decrease in the elastic ratio of tissue thickness compensator 1170 that is modified. For example, as shown in FIG. 40, the elastic ratio at point C is less than the elastic ratio at point B even though the compressive force applied to tissue thickness compensator 1170 by adjustment member 1176 at point C is greater than that applied at point B. compression force.
如上所述，一个或多个过程可用于影响与例如紧固件仓和/或外科紧固器械结合使用的材料的弹性比率和/或任何其他特性。材料的弹性比率和/或任何其他特性可在整个修改过程中改变。在一些情况下，此类改变可能是逐渐的，而在其他情况下，该改变可能是突然的。在各种情况下，修改过程的步骤中的一个或多个可导致材料的弹性比率增加，而一个或多个步骤可导致材料的弹性比率的降低。最终，在修改过程开始之前的初始弹性比率与修改过程之后的后续弹性比率之间的比较已完成时，可测量弹性比率的净变化。在各种情况下，在材料已被加热并且然后冷却之后，材料可具有改变的弹性比率。As noted above, one or more processes may be used to affect the elasticity ratio and/or any other properties of materials used in conjunction with, for example, fastener cartridges and/or surgical fastening instruments. The elastic ratio and/or any other properties of the material may be changed throughout the modification process. In some cases, such changes may be gradual, while in other cases, the change may be sudden. In various cases, one or more of the steps of the modification process may result in an increase in the elastic ratio of the material, while one or more steps may result in a decrease in the elastic ratio of the material. Finally, when the comparison between the initial elasticity ratio before the modification process begins and the subsequent elasticity ratio after the modification process is complete, a net change in the elasticity ratio can be measured. In various cases, the material may have a changed elastic ratio after the material has been heated and then cooled.
在某些情况下，可能需要将上述修改过程中的一个或多个应用于组织厚度补偿件。例如，第一修改过程可用于修改组织厚度补偿件的孔隙度，如上文相对于组织厚度补偿件1170所述。第一修改过程之后的第二修改过程可用于改变组织厚度补偿件的表面，如上文相对于组织厚度补偿件1140所述。此外，第三修改过程可用于将组织厚度补偿件修改为包括类似于组织厚度补偿件1120的纵向狭槽1122的纵向狭槽。在又一个第四修改过程中，组织厚度补偿件可被修改为包括类似于组织厚度补偿件1150的孔1152的孔。读者将理解，上述修改中的一些可在单个修改过程中组合或分组。例如，模具可被设计为包括模具1154的针1156和模具1126的中心梁1128。本公开可设想到其他修改布置方式。In some cases, it may be desirable to apply one or more of the above-described modification procedures to the tissue thickness compensator. For example, the first modification process may be used to modify the porosity of the tissue thickness compensator as described above with respect to the tissue thickness compensator 1170 . A second modification process following the first modification process may be used to alter the surface of the tissue thickness compensator, as described above with respect to tissue thickness compensator 1140 . Additionally, a third modification process may be used to modify the tissue thickness compensator to include a longitudinal slot similar to longitudinal slot 1122 of tissue thickness compensator 1120 . In yet another fourth modification procedure, the tissue thickness compensator can be modified to include apertures similar to apertures 1152 of tissue thickness compensator 1150 . The reader will understand that some of the above modifications may be combined or grouped in a single modification process. For example, the mold may be designed to include needle 1156 of mold 1154 and center beam 1128 of mold 1126 . Other modified arrangements are contemplated by this disclosure.
现在参见图38和图39，可使用上述修改过程中的一个或多个将组织厚度补偿件诸如组织厚度补偿件1190改变或修改为包括具有不同弹性比率、孔隙度和/或密度的部分。在某些情况下，可使用上述修改过程中的一个或多个将组织厚度补偿件1190修改为包括梯度孔隙形态(即，小孔隙的尺寸跨组织厚度补偿件1190的厚度沿一个方向逐渐增加成大孔隙)。此类形态对于组织生长或止血行为而言更为理想。另外，梯度还可与变化的生物吸收剖面相组合。短期吸收剖面可能更适合实现止血，而长期吸收剖面可以实现更好的组织愈合而不渗漏。Referring now to FIGS. 38 and 39 , a tissue thickness compensator, such as tissue thickness compensator 1190 , may be altered or modified to include portions having different elastic ratios, porosities, and/or densities using one or more of the modification procedures described above. In some cases, the tissue thickness compensator 1190 can be modified to include a gradient pore morphology (i.e., small pores that gradually increase in size across the thickness of the tissue thickness compensator 1190 in one direction) using one or more of the modification procedures described above. large pores). Such morphology is more ideal for tissue growth or hemostatic behavior. In addition, gradients can also be combined with varying bioabsorption profiles. A short-term absorption profile may be better suited to achieve hemostasis, while a long-term absorption profile may allow for better tissue healing without leakage.
再次参见图38和图39，组织厚度补偿件1190可具有与组织厚度补偿件1196的剩余部分不同的一个或多个区域几何形状。例如，如图38所示，组织厚度补偿件1190可包括一个或多个突起部分，诸如突起部分1196。另外，组织厚度补偿件1190可包括穿过包括一个或多个区域几何形状的组织厚度补偿件1190的均匀的或至少基本上均匀的第一弹性比率、第一孔隙度和/或第一密度，如图38所示。在某些情况下，可使用上述修改过程中的一个或多个来改变或修改组织厚度补偿件1190以改变或修改一个或多个区域几何形状并且/或者引起例如第一弹性比率、第一孔隙度和/或第一密度的局部改变。修改的组织厚度补偿件1190可包括一个或多个修改的区域，所述修改的区域具有与其他修改的区域以及/或者组织厚度补偿件1190的剩余部分的第一弹性比率、第一孔隙度和/或第一密度分别不同的弹性比率、孔隙度和/或密度。在某些情况下，所得一个或多个修改的区域可对应于一个或多个区域几何形状。例如，如图39所示，组织厚度补偿件1190可被改变或修改为与突起部分1196水平或至少基本上水平，并且形成例如平坦或至少基本上平坦的表面1198。修改的组织厚度补偿件1190可包括具有第一弹性比率、第一孔隙度和/或第一密度的第一部分1192以及具有分别不同于第一弹性比率、第一孔隙度和/或第一密度的第二弹性比率、第二孔隙度和/或第二密度的第二部分1194。第二部分1194可对应于突起部分1196，并且可导致与突起部分1196水平或至少基本上水平，以形成例如平坦或至少基本上平坦的表面1198。在某些方面，在组织厚度补偿件1190的修改之前突起部分1196的几何形状反映、匹配或类似在组织厚度补偿件1190已被修改之后第二部分1194的几何形状。Referring again to FIGS. 38 and 39 , tissue thickness compensator 1190 may have one or more regions of geometry that differ from the remainder of tissue thickness compensator 1196 . For example, as shown in FIG. 38 , tissue thickness compensator 1190 may include one or more raised portions, such as raised portion 1196 . Additionally, the tissue thickness compensator 1190 can comprise a uniform or at least substantially uniform first elasticity ratio, first porosity, and/or first density across the tissue thickness compensator 1190 comprising one or more region geometries, As shown in Figure 38. In some cases, the tissue thickness compensator 1190 may be changed or modified using one or more of the modification procedures described above to change or modify one or more zone geometries and/or to cause, for example, a first elasticity ratio, a first porosity degree and/or a local change in the first density. The modified tissue thickness compensator 1190 can include one or more modified regions having a first elasticity ratio, a first porosity, and and/or the first density differs in elasticity ratio, porosity and/or density, respectively. In some cases, the resulting one or more modified regions may correspond to one or more region geometries. For example, as shown in FIG. 39 , the tissue thickness compensator 1190 can be altered or modified to be level or at least substantially level with the raised portion 1196 and form a surface 1198 that is flat or at least substantially flat, for example. The modified tissue thickness compensator 1190 can include a first portion 1192 having a first elasticity ratio, a first porosity, and/or a first density and a A second portion 1194 of a second elasticity ratio, a second porosity, and/or a second density. The second portion 1194 may correspond to the raised portion 1196 and may be caused to be level or at least substantially level with the raised portion 1196 to form a flat or at least substantially flat surface 1198 , for example. In certain aspects, the geometry of the raised portion 1196 prior to modification of the tissue thickness compensator 1190 mirrors, matches, or resembles the geometry of the second portion 1194 after the tissue thickness compensator 1190 has been modified.
再次参见图37至图39，可以类似于组织厚度补偿件1170的方式使用模具1172来改变或修改组织厚度补偿件1190。例如，组织厚度补偿件1190可在接收器1174中加热到大于或等于组织厚度补偿件1190的材料组合物的玻璃化转变温度但小于其熔融温度的温度。在某些情况下，在组织厚度补偿件1190处于玻璃态时，调节构件1176可抵靠突起部分1196推进，从而压缩突起部分1196并且重新布置其几何形状以形成第二部分1194，如图39所示。对上文进行进一步描述，调节构件1176可被构造成能够维持抵靠突起部分1196的压缩持续足以允许组织厚度补偿件1190保持或至少基本上保持由调节构件1176施加的修改的时间段。在处于来自调节构件1176的压缩下时，可使组织厚度补偿件1190冷却或可主动冷却到低于其玻璃化转变温度的温度。在组织厚度补偿件1190转变退出玻璃态之后，调节构件1190可回缩。组织厚度补偿件1190可保持或至少基本上保持第二部分1194，如图39所示。在某些情况下，调节构件1176可在组织厚度补偿件1190被加热以达到玻璃态时，在组织厚度补偿件1190处于玻璃态时，以及/或者在组织厚度补偿件1190转变或冷却到玻璃态以下的温度时将压力施加到突起部分1196上。在某些情况下，例如在组织厚度补偿件1190的温度逐渐增加以使组织厚度补偿件1190朝玻璃态转变时，施加到组织厚度补偿件1190的突起部分1196的压力可逐渐朝阈值增加。在某些情况下，在组织厚度补偿件1190退出玻璃态时，在组织厚度补偿件1190退出玻璃态之前，以及/或者在组织厚度补偿件1190退出玻璃态之后，施加到组织厚度补偿件1190的突起部分1196的压力可被移除、逐渐移除、或至少部分地减小。Referring again to FIGS. 37-39 , the tissue thickness compensator 1190 can be altered or modified using the mold 1172 in a similar manner to the tissue thickness compensator 1170 . For example, tissue thickness compensator 1190 may be heated in receptacle 1174 to a temperature greater than or equal to the glass transition temperature of the material composition of tissue thickness compensator 1190 but less than its melting temperature. In some cases, adjustment member 1176 may be advanced against raised portion 1196 while tissue thickness compensator 1190 is in the glassy state, thereby compressing raised portion 1196 and rearranging its geometry to form second portion 1194, as shown in FIG. 39 Show. Further to the above, adjustment member 1176 may be configured to maintain compression against raised portion 1196 for a period of time sufficient to allow tissue thickness compensator 1190 to maintain, or at least substantially maintain, the modification applied by adjustment member 1176 . While under compression from adjustment member 1176, tissue thickness compensator 1190 may be allowed to cool or may be actively cooled to a temperature below its glass transition temperature. After the tissue thickness compensator 1190 transitions out of the glass state, the adjustment member 1190 can be retracted. The tissue thickness compensator 1190 can retain, or at least substantially retain, the second portion 1194, as shown in FIG. 39 . In some cases, adjustment member 1176 may be used when tissue thickness compensator 1190 is heated to a glassy state, while tissue thickness compensator 1190 is in a glassy state, and/or when tissue thickness compensator 1190 transitions or cools to a glassy state Pressure is applied to the protruding portion 1196 at a temperature below. Under certain circumstances, such as when the temperature of the tissue thickness compensator 1190 is gradually increased to transition the tissue thickness compensator 1190 toward a glassy state, the pressure applied to the raised portion 1196 of the tissue thickness compensator 1190 may gradually increase toward a threshold. In some cases, the tissue thickness compensator 1190 is applied to the tissue thickness compensator 1190 when the tissue thickness compensator 1190 exits the glass state, before the tissue thickness compensator 1190 exits the glass state, and/or after the tissue thickness compensator 1190 exits the glass state. The pressure of the raised portion 1196 may be removed, gradually removed, or at least partially reduced.
现在参见图41至图43，可使用传统冻干技术和/或任何其他合适的技术来制备组织厚度补偿件，诸如组织厚度补偿件1200。另外，组织厚度补偿件1200可被修改或改变以用于例如外科手术中。组织厚度补偿件1200可在许多方面类似于其他组织厚度补偿件，诸如组织厚度补偿件22020(图9)和/或组织厚度补偿件1120(图26)。例如，如同组织厚度补偿件22020，组织厚度补偿件1200可与端部执行器22090一起使用。此外，如图41至图43所示，组织厚度补偿件1200可被修改为包括纵向狭槽1202，该纵向狭槽如同刀狭槽22025，可将用于切割部分10053的组织厚度补偿件刀路径限定在第一缝合部分1204a和第二缝合部分1204b之间。此外，第一缝合部分1204a和第二缝合部分1204b可在许多方面类似于组织厚度补偿件22020的第一缝合部分22021a(图9)和第二缝合部分22021b(图9)。另外，狭槽1202可被构造成能够可释放地连接第一缝合部分1204a和第二缝合部分1204b，使得在与端部执行器22090一起使用时，切割部分10053可朝远侧推进穿过狭槽1202以横切狭槽1202并且将第一缝合部分1204a和第二缝合部分1204b分离。Referring now to FIGS. 41-43 , a tissue thickness compensator, such as tissue thickness compensator 1200 , can be prepared using conventional freeze-drying techniques and/or any other suitable technique. In addition, tissue thickness compensator 1200 may be modified or altered for use in, for example, surgery. Tissue thickness compensator 1200 can be similar in many respects to other tissue thickness compensators, such as tissue thickness compensator 22020 (FIG. 9) and/or tissue thickness compensator 1120 (FIG. 26). For example, like tissue thickness compensator 22020 , tissue thickness compensator 1200 may be used with end effector 22090 . In addition, as shown in FIGS. 41-43 , the tissue thickness compensator 1200 can be modified to include a longitudinal slot 1202 that, like the knife slot 22025 , can direct the path of the tissue thickness compensator knife for the cutting portion 10053 . Defined between the first stitched portion 1204a and the second stitched portion 1204b. Additionally, first stitched portion 1204a and second stitched portion 1204b can be similar in many respects to first stitched portion 22021a ( FIG. 9 ) and second stitched portion 22021b ( FIG. 9 ) of tissue thickness compensator 22020 . Additionally, the slot 1202 can be configured to releasably connect the first sutured portion 1204a and the second sutured portion 1204b such that the cutting portion 10053 can be advanced distally through the slot when used with the end effector 22090 1202 to traverse the slot 1202 and separate the first stitched portion 1204a from the second stitched portion 1204b.
再次参见图41至图43，组织厚度补偿件1200可在组装有端部执行器诸如端部执行器22090(图9)之前被修改。另选地，组织厚度补偿件1200可在其已组装有端部执行器之后被修改。如上所述，组织厚度补偿件1200可使用传统冻干技术和/或任何其他合适的技术来制备。空间创建器1206可用于在热压制过程中修改组织厚度补偿件1200，如图41至图43所示。例如，空间创建器1206可被加热到大于或等于组织厚度补偿件1200的材料组合物的熔融温度的温度。空间创建器1206然后可与组织厚度补偿件1200对准并且插入组织厚度补偿件中，以形成纵向狭槽1202。空间创建器1206可熔融穿过组织厚度补偿件1200以针对纵向狭槽1202创建空间。空间创建器1206可在达到组织厚度补偿件1200内的所需深度之后回缩。在某些情况下，热压制过程可通过将加热的空间创建器1206重新插入穿过组织厚度补偿件1200来重复以加宽针对纵向狭槽1202创建的空间。Referring again to FIGS. 41-43 , tissue thickness compensator 1200 may be modified prior to assembly with an end effector such as end effector 22090 ( FIG. 9 ). Alternatively, tissue thickness compensator 1200 may be modified after it has been assembled with an end effector. As noted above, tissue thickness compensator 1200 may be prepared using conventional freeze-drying techniques and/or any other suitable technique. Space creator 1206 may be used to modify tissue thickness compensator 1200 during thermal compression, as shown in FIGS. 41-43 . For example, space creator 1206 may be heated to a temperature greater than or equal to the melting temperature of the material composition of tissue thickness compensator 1200 . Space creator 1206 may then be aligned with and inserted into tissue thickness compensator 1200 to form longitudinal slot 1202 . Space creator 1206 may be fused through tissue thickness compensator 1200 to create a space for longitudinal slot 1202 . Space creator 1206 may retract after reaching a desired depth within tissue thickness compensator 1200 . In some cases, the thermal pressing process may be repeated by reinserting heated space creator 1206 through tissue thickness compensator 1200 to widen the space created for longitudinal slot 1202 .
再次参见图41至图43，空间创建器1206可包括热金属丝。例如，空间创建器1206可包括可由例如镍铬合金或不锈钢制成的薄的、拉紧的金属线，或预成型为所需形状的较厚线。热金属丝可通过电阻加热到所需温度。在空间创建器1206的热金属丝穿过组织厚度补偿件1200的材料时，来自热金属丝的热量可正好在接触之前使材料蒸发。在某些情况下，热金属丝可具有圆柱形或基本上圆柱形的形状，如图42所示。纵向狭槽1202的深度可部分地取决于空间创建器1206穿过组织厚度补偿件1200的插入深度，并且纵向狭槽1202的宽度可部分地取决于空间创建器1206的热金属丝的直径。Referring again to FIGS. 41-43 , the space creator 1206 may comprise a heated wire. For example, the space creator 1206 may comprise thin, tensioned metal wire, which may be made of, for example, nichrome or stainless steel, or a thicker wire preformed into a desired shape. A hot wire can be heated to the desired temperature by means of electrical resistance. As the heated wire of space creator 1206 passes through the material of tissue thickness compensator 1200, the heat from the heated wire may vaporize the material just prior to contact. In some cases, the hot wire may have a cylindrical or substantially cylindrical shape, as shown in FIG. 42 . The depth of longitudinal slot 1202 may depend in part on the insertion depth of space creator 1206 through tissue thickness compensator 1200 , and the width of longitudinal slot 1202 may depend in part on the diameter of the space creator's 1206 thermal wire.
在某些情况下，空间创建器1206可部分地插入穿过组织厚度补偿件的整个厚度。在某些情况下，空间创建器1206可完全插入穿过组织厚度补偿件1200的整个厚度以形成延伸穿过组织厚度补偿件1200的整个厚度的开口、孔和/或狭槽。在某些情况下，空间创建器1206可插入穿过组织厚度补偿件1200的第一侧并且穿过例如组织厚度补偿件1200的可与第一侧相对的第二侧离开。In some cases, space creator 1206 may be inserted partially through the entire thickness of the tissue thickness compensator. In some cases, space creator 1206 may be fully inserted through the entire thickness of tissue thickness compensator 1200 to form an opening, hole, and/or slot extending through the entire thickness of tissue thickness compensator 1200 . In some cases, space creator 1206 can be inserted through a first side of tissue thickness compensator 1200 and exit through, for example, a second side of tissue thickness compensator 1200 , which can be opposite the first side.
本文公开了许多工艺，所述工艺利用热能量来修改组织厚度补偿件。此类工艺可称为制毡工艺。在某些情况下，制毡工艺也可利用向组织厚度补偿件施加压缩力和/或拉力。在其他情况下，制毡工艺不可利用向组织厚度补偿件施加压缩力和/或拉力。在任一种情况下，本文所公开的制毡工艺也可用于例如修改和适当地植入层和/或支撑材料。A number of processes are disclosed herein that utilize thermal energy to modify tissue thickness compensators. Such processes may be referred to as felting processes. In some cases, the felting process may also utilize the application of compressive and/or tensile forces to the tissue thickness compensator. In other cases, the felting process is not available to apply compressive and/or tensile forces to the tissue thickness compensator. In either case, the felting process disclosed herein may also be used, for example, to modify and properly implant layers and/or support materials.
在各种情况下，组织厚度补偿件组件可包含聚合物组合物。聚合物组合物可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。在各种情况下，聚合物组合物可包含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，或者可具有梯度孔形态(即，在一个方向跨泡沫的厚度，小孔尺寸逐渐增加变成大孔)。在各种情况下，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，组织厚度补偿件组件可包括通过丝状基质增强的泡沫，或者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伸展，以在组织上进一步提供压缩。在各种情况下，组织厚度补偿件组件还可由材料和/或第二层或第三层上的涂层构成，该涂层在体液存在下伸展，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。在某些情况下，可使用例如能提供附加柔韧性、刚度、和/或强度的纤维非织造材料或纤维网孔类型元件来增强组织厚度补偿件组件。在各种情况下，组织厚度补偿件组件具有多孔形态，该多孔形态表现出梯度结构，例如，在一个表面上是小孔，而在另一表面上是较大的孔。此类形态对于组织生长或止血行为而言更为理想。另外，梯度还可与变化的生物吸收剖面相组合。短期吸收剖面可能更适合实现止血；而长期吸收剖面可以实现更好的组织愈合又不会渗漏。In various instances, the tissue thickness compensator assembly can comprise a polymer composition. A polymer composition may include 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. In each case, the polymer composition may comprise, 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, in one direction across the thickness of the foam, small cells gradually increasing in size to larger cells). In various cases, the polymeric composition can include porous scaffolds, porous matrices, gel matrices, hydrogel matrices, solution matrices, filamentary matrices, tubular matrices, composite matrices, membrane matrices, biostable polymers, and biostable One or more of the degraded polymers, and combinations thereof. For example, the tissue thickness compensator assembly may comprise a foam reinforced by a filamentous matrix, or may comprise a foam with an additional layer of hydrogel that stretches in the presence of bodily fluids to provide further compression on the tissue . In various cases, the tissue thickness compensator assembly may also be comprised of a material and/or a coating on the second or third layer that stretches in the presence of bodily fluid 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. In some cases, the tissue thickness compensator assembly may be reinforced with, for example, fibrous nonwoven or fibrous mesh type elements that provide additional flexibility, stiffness, and/or strength. In each case, the tissue thickness compensator assembly 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. In addition, gradients can also be combined with varying bioabsorption profiles. Short-term absorption profiles may be better suited to achieve hemostasis; while long-term absorption profiles allow for better tissue healing without leakage.
非合成聚合物的示例包括但不限于冻干多糖、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)。合成的可吸收聚合物的示例包括但不限于聚(乳酸)(PLA)、聚(L-乳酸)(PLLA)、聚己内酯(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)、多羟基链烷酸酯(PHA)、乙交酯和ε-己内酯的共聚物(PGCL)、乙交酯和三亚甲基碳酸酯的共聚物、聚(癸二酸甘油酯)(PGS)、聚对二氧环己酮、聚(原酸酯)、聚酸酐、多糖、聚(酯-酰胺)、酪氨酸基聚芳酯、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(B-羟基丁酸)、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，以及它们的组合。在各种情况下，该聚合物组合物可包含例如按聚合物组合物的重量计大约50％至大约90％的PLLA，和按聚合物组合物的重量计大约50％至大约10％的PCL。在至少一个实施方案中，该聚合物组合物可包含例如按重量计大约70％的PLLA，和按重量计大约30％的PCL。在各种情况下，该聚合物组合物可包含例如按聚合物组合物的重量计大约55％至大约85％的PGA，和按聚合物组合物的重量计15％至45％的PCL。在至少一个实施方案中，该聚合物组合物可包含例如按重量计大约65％的PGA，和按重量计大约35％的PCL。在各种情况下，该聚合物组合物可包含例如按聚合物组合物的重量计大约90％至大约95％的PGA，和按聚合物组合物的重量计大约5％至大约10％的PLA。Examples of non-synthetic polymers include, but are not limited to, lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and oxidized regenerated cellulose (ORC). Examples of synthetic absorbable polymers 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), copolymer of glycolide and ε-caprolactone (PGCL), glycolide and Copolymers of trimethylene carbonate, poly(glyceryl sebacate) (PGS), polydioxanone, poly(orthoesters), polyanhydrides, polysaccharides, poly(ester-amides), tyramine Acid-based polyarylate, tyrosine-based polyimidocarbonate, tyrosine-based polycarbonate, poly(D,L-lactide-urethane), poly(B-hydroxybutyric acid), poly (E-caprolactone), polyethylene glycol (PEG), poly[bis(carboxyphenoxy)phosphazene], poly(amino acid), pseudopoly(amino acid), absorbable polyurethane, and combinations thereof. In each case, the polymer composition may comprise, for example, from about 50% to about 90% by weight of the polymer composition of PLLA, and from about 50% to about 10% by weight of the polymer composition of PCL . In at least one embodiment, the polymer composition may comprise, for example, about 70% by weight PLLA, and about 30% by weight PCL. In each case, the polymer composition can comprise, for example, from about 55% to about 85% by weight of the polymer composition of PGA, and from 15% to 45% by weight of the polymer composition of PCL. In at least one embodiment, the polymer composition may comprise, for example, about 65% by weight PGA, and about 35% by weight PCL. In each case, the polymer composition may comprise, for example, from about 90% to about 95% by weight of the polymer composition of PGA, and from about 5% to about 10% by weight of the polymer composition of PLA .
在各种情况下，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。合适的可生物吸收的、生物相容性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。在一个实施方案中，弹性体共聚物为乙交酯和ε-己内酯的共聚物。在另一个实施方案中，弹性体共聚物为丙交酯和ε-己内酯的共聚物。In various instances, 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 , 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 lactide 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-dioxane Elastomeric copolymers of hexanone (the molar ratio of ε-caprolactone to p-dioxanone is preferably from about 30:70 to about 70:30); p-dioxanone and trimethylene carbonate Elastomeric copolymers of esters (preferably in a molar ratio of p-dioxanone to trimethylene carbonate 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 about 30:70 to about 70:30); trimethylene carbonate and lactide (including L-lactide, D-lactide, their blends or lactic acid copolymers) of elastomeric copolymers (the molar ratio of trimethylene carbonate to lactide is preferably from about 30:70 to about 70:30); and blends thereof. In one embodiment, the elastomeric copolymer is a copolymer of glycolide and ε-caprolactone. In another embodiment, 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和公布于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.
在各种情况下，合成的可吸收聚合物可例如包括下列物质中的一种或多种：可以商品名称VICRYL(polyglactic 910)从Ethicon,Inc.商购获得的90/10聚(乙交酯-L-丙交酯)共聚物、可以商品名称DEXON从American Cyanamid Co.商购获得的聚乙交酯、可以商品名称PDS从Ethicon,Inc.商购获得的聚二氧杂环己酮、可以商品名称MAXON从AmericanCyanamid Co.商购获得的聚(乙交酯-三亚甲基碳酸酯)无规嵌段共聚物、可以商品名称MONOCRYL从Ethicon商购获得的75/25聚(乙交酯-E-己内酯-poliglecaprolactone 25)共聚物。In each case, the synthetic absorbable polymer may, for example, include one or more of the following: 90/10 poly(glycolide) commercially available under the trade designation VICRYL (polyglactic 910) from Ethicon, Inc. -L-lactide) copolymer, polyglycolide commercially available under the trade name DEXON from American Cyanamid Co., polydioxanone commercially available under the trade name PDS from Ethicon, Inc., available Poly(glycolide-trimethylene carbonate) random block copolymer commercially available under the trade name MAXON from American Cyanamid Co., 75/25 poly(glycolide-E - caprolactone - poliglecaprolactone 25) copolymer.
合成的非可吸收聚合物的示例包括但不限于聚氨酯泡沫塑料、聚丙烯(PP)、聚乙烯(PE)、聚碳酸酯、聚酰胺，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、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，诸如硅酮、聚异戊二烯和橡胶。在各种情况下，所述合成聚合物可包括可以商标名称GORE-TEX Soft Tissue Patch从W.L.Gore&Associates,Inc.商购获得的膨体聚四氟乙烯(ePTFE)，和可以商标名称NASOPORE从Polyganics商购获得的共聚醚酯聚氨酯泡沫。Examples of synthetic non-absorbable polymers include, but are not limited to, polyurethane foam, polypropylene (PP), polyethylene (PE), polycarbonate, polyamides such as nylon, polyvinyl chloride (PVC), polymethacrylic acid Methyl ester (PMMA), polystyrene (PS), polyester, polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE), polytrifluorochloroethylene (PTFCE), polyvinyl fluoride (PVF), fluorinated Ethylene propylene (FEP), polyacetal, polysulfone, and combinations thereof. Synthetic non-absorbable polymers may include, but are not limited to, foamed and cellular elastomers, such as silicone, polyisoprene, and rubber. In each case, the synthetic polymer may include expanded polytetrafluoroethylene (ePTFE) commercially available under the trade name GORE-TEX Soft Tissue Patch from W.L. Gore & Associates, Inc., and under the trade name NASOPORE from Polyganics. Purchased copolyetherester polyurethane foam.
组织厚度补偿件组件的聚合物组合物的特征可在于例如孔隙度百分比、孔尺寸、和/或硬度。在各种情况下，该聚合物组合物可具有例如按体积计大约30％至大约99％的孔隙度百分比。在某些情况下，该聚合物组合物可具有例如按体积计大约60％至大约98％的孔隙度百分比。在各种情况下，该聚合物组合物可具有例如按体积计大约85％至大约97％的孔隙度百分比。在至少一个实施方案中，该聚合物组合物可包含例如按重量计大约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％的孔隙度。在至少一个此类实施方案中，因此，该聚合物组合物将包含按体积计大约10％的共聚物。在至少一个实施方案中，该聚合物组合物可包含例如按重量计大约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％至大约95％的孔隙度百分比。在各种情况下，聚合物组合物可包括按体积计大于85％的孔隙度。聚合物组合物可具有例如大约5微米至大约2000微米的孔尺寸。在各种情况下，聚合物组合物可具有例如介于大约10微米至大约100微米之间的孔尺寸。在至少一个此类实施方案中，该聚合物组合物可包含例如PGA和PCL的共聚物。在某些情况下，聚合物组合物可具有例如介于大约100微米至大约1000微米之间的孔尺寸。在至少一个此类实施方案中，该聚合物组合物可包含例如PLLA和PCL的共聚物。根据某些方面，聚合物组合物的硬度可以用肖氏硬度表示，该肖氏硬度可被定义为用硬度计(诸如肖氏硬度计)测定的材料对永久压痕的抗性。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(其全文以引用方式并入本文)，用硬度计压头脚向材料施压。可将硬度计压头脚压入材料，保持足够长的时间(诸如15秒)，在这种情况下，随后由合适的标度读取读数。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。该读数是无量纲的。在各种情况下，可根据ASTM D2240-00，采用任何合适的标度例如A类和/或OO类标度来确定硬度。在各种情况下，组织厚度补偿件组件的聚合物组合物可具有例如大约4A至大约16A的肖氏A硬度值，该硬度值在肖氏OO范围内为大约45OO至大约65OO。在至少一个此类实施方案中，该聚合物组合物可包含例如PLLA/PCL共聚物或PGA/PCL共聚物。在各种情况下，组织厚度补偿件组件的聚合物组合物可具有小于15A的肖氏A硬度值。在各种情况下，组织厚度补偿件组件的聚合物组合物可具有小于10A的肖氏A硬度值。在各种情况下，组织厚度补偿件组件的聚合物组合物可具有小于5A的肖氏A硬度值。在某些情况下，聚合物材料可具有例如大约35OO至大约75OO的肖氏OO组合物值。The polymer composition of the tissue thickness compensator assembly can be characterized by, for example, percent porosity, pore size, and/or hardness. In various cases, the polymer composition can have a porosity percentage of, for example, from about 30% to about 99% by volume. In some cases, the polymer composition can have a porosity percentage of, for example, from about 60% to about 98% by volume. In various cases, the polymer composition can have a percent porosity of, for example, from about 85% to about 97% by volume. In at least one embodiment, the polymer composition can comprise, for example, about 70% by weight of PLLA and about 30% by weight of PCL, and can include, for example, about 90% by volume of porosity. In at least one such embodiment, therefore, the polymer composition will comprise about 10% by volume of the copolymer. In at least one embodiment, the polymer composition can comprise, for example, about 65% by weight of PGA and about 35% by weight of PCL, and can have a porosity of, for example, about 93% to about 95% by volume. percentage. In various cases, the polymer composition can 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. In each case, the polymer composition can have a pore size, for example, between about 10 microns and about 100 microns. In at least one such embodiment, the polymer composition may comprise, for example, a copolymer of PGA and PCL. In some cases, the polymer composition can have a pore size, for example, between about 100 microns and about 1000 microns. In at least one such embodiment, the polymer composition may comprise, for example, a copolymer of PLLA and PCL. According to certain aspects, the hardness of the polymer composition can be expressed in Shore hardness, which can be defined as the resistance of a material to permanent indentation as measured with a durometer, such as a Shore durometer. To evaluate the durometer value for a given material, a durometer indenter foot is applied to the material in accordance with ASTM procedure D2240-00 entitled "Standard Test Method for Rubber Property—Durometer Hardness," which is hereby incorporated by reference in its entirety. pressure. The durometer foot may be pressed into the material for a sufficient time (such as 15 seconds), in which case the reading is then taken by a suitable 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 readout is dimensionless. In each case, hardness may be determined according to ASTM D2240-00 using any suitable scale, such as the Type A and/or Type OO scales. In various instances, the polymer composition of the tissue thickness compensator assembly can have a Shore A hardness value of, for example, about 4A to about 16A, with a hardness value of about 45OO to about 65OO in the Shore OO range. In at least one such embodiment, the polymer composition can comprise, for example, a PLLA/PCL copolymer or a PGA/PCL copolymer. In various instances, the polymer composition of the tissue thickness compensator assembly can have a Shore A hardness value of less than 15A. In various instances, the polymer composition of the tissue thickness compensator assembly can have a Shore A hardness value of less than 10A. In various instances, the polymer composition of the tissue thickness compensator assembly can have a Shore A hardness value of less than 5A. In some cases, the polymeric material can have a Shore OO composition value of, for example, from about 3500 to about 7500.
在各种情况下，聚合物组合物可具有上述识别出的特性中的至少两种。在各种情况下，聚合物组合物可具有上述识别出的特性中的至少三种。该聚合物组合物可具有例如按体积计85％至97％的孔隙度、5微米至2000微米的孔尺寸、和4A至16A的肖氏A硬度值，以及45OO至65OO的肖氏OO硬度值。在至少一个实施方案中，例如，聚合物组合物可包含按聚合物组合物的重量计70％的PLLA和按聚合物组合物的重量计30％的PCL，并具有按体积计90％的孔隙度、100微米至1000微米的孔尺寸、和4A至16A的肖氏A硬度值、以及45OO至65OO的肖氏OO硬度值。在至少一个实施方案中，例如，聚合物组合物可包含按聚合物组合物的重量计65％的PGA和按聚合物组合物的重量计35％的PCL，并具有按体积计93％至95％的孔隙度、10微米至100微米的孔尺寸、和4A至16A的肖氏A硬度值、以及45OO至65OO的肖氏OO硬度值。In each case, the polymer composition may have at least two of the above-identified properties. In each case, the 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 . In at least one embodiment, for example, the polymer composition can comprise 70% PLLA by weight of the polymer composition and 30% PCL by weight of the polymer composition and have 90% porosity by volume degrees, pore sizes from 100 microns to 1000 microns, and Shore A hardness values from 4A to 16A, and Shore OO hardness values from 45OO to 65OO. In at least one embodiment, for example, the polymer composition can comprise 65% by weight of the polymer composition of PGA and 35% by weight of the polymer composition of PCL, and have a volume of 93% to 95% % porosity, pore size from 10 microns to 100 microns, and Shore A hardness values from 4A to 16A, and Shore OO hardness values from 45OO to 65OO.
在各种情况下，聚合物组合物可包含药物活性剂。聚合物组合物可释放治疗有效量的药物活性剂。在各种情况下，当聚合物组合物被解吸/吸收时药物活性剂可被释放。在各种情况下，药物活性剂可被释放到流体诸如流经聚合物组合物上方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，例如血纤维蛋白、凝血酶和氧化再生纤维素(ORC)；抗炎剂药物，例如双氯芬酸、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抗微生物剂，例如三氯生、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，例如顺铂、丝裂霉素、阿霉素。In each case, the polymer composition may contain a pharmaceutically active agent. The polymer composition releases a therapeutically effective amount of a pharmaceutically active agent. In each case, the pharmaceutically active agent can be released when the polymer composition is desorbed/absorbed. In various instances, the pharmaceutically active agent may 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 agent drugs such as diclofenac, aspirin, naproxen, sulindac, and hydrogenated Cortisone; antibiotic and antimicrobial drugs or antimicrobial agents such as triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, chloramphenicol; and anticancer agents such as cisplatin, silk Split mycin, doxorubicin.
本文公开了用于改变组织厚度补偿件的各种方法。此类方法可用于改变例如与紧固件仓和/或外科紧固器械一起使用的任何合适的层。此类层可包含可使用任何合适的工艺形成的小于百分之百致密的组合物。例如，此类工艺可包括例如挤出、注模、织造、冻干、气体发泡和/或熔喷工艺。一些工艺可能产生泡沫，而其他工艺可能不产生泡沫；然而，在任何情况下，都可设想到将所有此类实施方案与本文所公开的所有实施方案一起使用。Various methods for changing the tissue thickness compensator are disclosed herein. Such methods may be used to alter any suitable layer, for example, for use with fastener cartridges and/or surgical fastening instruments. Such layers may comprise less than one hundred percent dense compositions that may be formed using any suitable process. Such processes may include, for example, extrusion, injection molding, weaving, lyophilization, gas foaming, and/or meltblowing processes. Some processes may produce foam while others may not; however, in any event, all such embodiments are contemplated for use with all of the embodiments disclosed herein.
在各种实施方案中，参见图44至图46，外科紧固器械的端部执行器诸如端部执行器100可被构造成能够捕获、紧固和/或切入组织。端部执行器100可包括紧固件仓110，并且另外包括击发构件140，该击发构件可被推进穿过紧固件仓110以将可移除地储存在钉仓110内的钉部署到捕获在端部执行器100内的组织中。在各种情况下，击发构件140可从近侧位置(图44)朝端部执行器100的远侧端部推进以同时部署钉并且横切组织。然而存在这样的一些情况，其中可能不需要将击发构件140朝端部执行器100的远侧端部推进。例如，端部执行器100的紧固件仓110可为可移除的以及/或者可替换的，在紧固件仓110不定位在端部执行器100内的情况下，对于击发构件140而言可能不需要在端部执行器100内推进。在击发构件140被推进穿过端部执行器100而无需紧固件仓定位在端部执行器100内的情况下，击发构件140的刀刃142可切入捕获在端部执行器100内的组织而无需同时紧固组织。类似地，在定位在端部执行器100内的紧固件仓已被预先使用，或延伸，并且紧固件中的至少一些已从紧固件仓部署的情况下，对于击发构件140而言可能不需要在端部执行器100内推进。在击发构件140被推进穿过端部执行器100同时预先延伸的紧固件仓定位在端部执行器100内的情况下，击发构件140的刀刃142可切入捕获在端部执行器内的组织而无需同时紧固组织。在各种实施方案中，端部执行器100可包括一个或多个锁定系统，当紧固件仓不存在于端部执行器100内时以及/或者当定位在端部执行器100内的紧固件仓已至少部分地延伸时，该锁定系统可防止击发构件140朝远侧推进。各种锁定系统在名称为“SURGICALSTAPLING INSTRUMENT HAVING A SPENT CARTRIDGE LOCKOUT”并且公布于2006年1月24日的美国专利6,988,649中有所公开。名称为“SURGICAL STAPLING INSTRUMENT HAVING ASPENT CARTRIDGE LOCKOUT”的美国专利6,988,649的全部公开内容以引用方式并入本文。In various embodiments, referring to FIGS. 44-46 , an end effector of a surgical fastening instrument, such as end effector 100 , can be configured to capture, fasten, and/or cut into tissue. The end effector 100 can include a fastener cartridge 110 and additionally include a firing member 140 that can be advanced through the fastener cartridge 110 to deploy the staples removably stored within the staple cartridge 110 to a captured in the tissue within the end effector 100 . In various circumstances, firing member 140 can be advanced from a proximal position ( FIG. 44 ) toward the distal end of end effector 100 to simultaneously deploy staples and transect tissue. However, there are some situations in which it may not be necessary to advance firing member 140 toward the distal end of end effector 100 . For example, the fastener cartridge 110 of the end effector 100 may be removable and/or replaceable for the firing member 140 without the fastener cartridge 110 positioned within the end effector 100 . Words may not need to be advanced within end effector 100. In the event that firing member 140 is advanced through end effector 100 without a fastener cartridge being positioned within end effector 100, cutting edge 142 of firing member 140 may cut into tissue captured within end effector 100 without There is no need to fasten the tissue at the same time. Similarly, where the fastener cartridge positioned within end effector 100 has been previously used, or extended, and at least some of the fasteners have been deployed from the fastener cartridge, for firing member 140 Advancement within end effector 100 may not be required. With the firing member 140 advanced through the end effector 100 while the pre-extended fastener cartridge is positioned within the end effector 100, the cutting edge 142 of the firing member 140 can cut into tissue captured within the end effector without tightening the tissue at the same time. In various embodiments, the end effector 100 can include one or more locking systems that are used when a fastener magazine is not present in the end effector 100 and/or when a fastener positioned in the end effector 100 The locking system prevents distal advancement of the firing member 140 when the firmware cartridge has been at least partially extended. Various locking systems are disclosed in US Patent 6,988,649 entitled "SURGICAL STAPLING INSTRUMENT HAVING A SPENT CARTRIDGE LOCKOUT" and issued January 24, 2006. The entire disclosure of US Patent 6,988,649, entitled "SURGICAL STAPLING INSTRUMENT HAVING ASPENT CARTRIDGE LOCKOUT," is incorporated herein by reference.
再次参见图44至图46，紧固件仓110可包括仓体和组织厚度补偿件120，其中对上文进行进一步描述，组织厚度补偿件120可抵靠由端部执行器100通过可移除地储存在仓体内的紧固件捕获的组织植入。组织厚度补偿件120可定位在仓体的顶部表面或平台上面，其中可移除地储存在限定于仓体中的钉腔内的钉180可由例如击发构件(诸如滑动件130和/或击发构件140)从钉腔射出。在某些实施方案中，紧固件仓110还可包括驱动器，该驱动器被构造成能够支撑钉180并且传递滑动件130到钉180的运动，以便使钉180在未击发位置和击发位置之间运动。在各种情况下，当钉180处于其未击发位置中时，钉180可至少部分地嵌入组织厚度补偿件120中，而在某些情况下，当钉180处于其未击发位置中时，钉180可将组织厚度补偿件120保持在仓平台上方的适当位置中。在将钉180部署到组织中之前，在组织厚度补偿件120相对于仓体和/或钉180运动的情况下，在一些情况下，组织厚度补偿件120可使钉180相对于其优选位置运动或远离其优选位置运动。此外，在钉180被部署之前，在组织厚度补偿件120从仓110移除的情况下，仓110可能不再适合于其初始预期用途。鉴于以上所述，如下文更详细地讨论，端部执行器100可包括锁定件，该锁定件可被构造成能够在钉180被部署之前，在组织厚度补偿件120从仓体移除或者变得至少部分地从仓体脱离的情况下防止击发构件140和/或滑动件130朝远侧推进以部署钉180。Referring again to FIGS. 44-46 , the fastener cartridge 110 can include a cartridge body and a tissue thickness compensator 120 , wherein, as further described above, the tissue thickness compensator 120 can be abutted by the end effector 100 through a removable Tissue implants captured by fasteners stored securely within the cartridge body. Tissue thickness compensator 120 can be positioned on the top surface or deck of the cartridge body, wherein staples 180 removably stored in staple cavities defined in the cartridge body can be activated by, for example, a firing member such as sled 130 and/or firing member 140) shoot out from the nail cavity. In certain embodiments, fastener cartridge 110 may also include a driver configured to support staples 180 and to transmit movement of sled 130 to staples 180 to move staples 180 between an unfired position and a fired position. sports. In various circumstances, the staples 180 can be at least partially embedded in the tissue thickness compensator 120 when the staples 180 are in their unfired positions, and in some cases, the staples 180 can be at least partially embedded in the tissue thickness compensator 120 when the staples 180 are in their unfired positions. 180 can hold tissue thickness compensator 120 in place above the deck of the cartridge. With tissue thickness compensator 120 moving relative to cartridge body and/or staples 180 prior to deployment of staples 180 into tissue, tissue thickness compensator 120 may, in some cases, move staples 180 relative to their preferred positions Or move away from its preferred position. Furthermore, in the event that tissue thickness compensator 120 is removed from cartridge 110 before staples 180 are deployed, cartridge 110 may no longer be suitable for its original intended use. In view of the above, and as discussed in greater detail below, end effector 100 can include a lock that can be configured to enable tissue thickness compensator 120 to be removed from the cartridge body or to be deformed before staple 180 is deployed. Firing member 140 and/or sled 130 are prevented from advancing distally to deploy staples 180 without at least partially disengaging from the cartridge body.
再次参见图44至图46，组织厚度补偿件120可包括(一)被构造成能够由钉180捕获的主体121，以及(二)从主体121延伸的锁定销122。在各种情况下，当组织厚度补偿件120未从仓体平台上方的合适位置移除或基本上从该位置运动时，锁定销122可包括嵌入主体121中的第一端部123和定位在击发构件140和滑动件130中间的第二端部124。在这样的位置中，锁定销122的第二端部124可定位在限定在滑动件130上的肩部或架134和从击发杆140朝远侧延伸的突起144中间。换句话讲，当锁定销122定位在滑动件130和击发杆140中间时，锁定销122和滑动件130可协作以将击发杆140支撑在限定于紧固件仓110中的锁定肩部112上方的解锁位置中，使得当远侧击发力施加到击发杆140时，击发杆140可朝远侧推进滑动件130以击发钉180。当组织厚度补偿件120从仓110移除并且/或者基本上从相对于仓体的所需位置脱离时，主要参见图45，锁定销122可能不再定位在滑动件130和击发构件140中间，并且/或者可能不能够将击发构件140支撑在其解锁位置(图44)中。在此类情况下，击发构件140可变得定位在锁定位置中，使得击发构件140的远侧推进被锁定肩部112防止。在至少一种这样的情况下，端部执行器100还可包括例如被构造成能够将击发构件140偏压到其锁定状态中的偏压构件，诸如弹簧。在某些情况下，偏压构件可将击发构件140偏压成例如与滑动件130接触，而无需定位在其间的锁定销122，该锁定销可包括击发构件140的锁定位置。Referring again to FIGS. 44-46 , the tissue thickness compensator 120 can include (a) a body 121 configured to be captured by a staple 180 , and (ii) a locking pin 122 extending from the body 121 . In various circumstances, when the tissue thickness compensator 120 is not removed from or substantially moved from a position above the deck of the cartridge body, the locking pin 122 can include a first end 123 embedded in the body 121 and positioned at the The second end 124 intermediate the firing member 140 and the slider 130 . In such a position, the second end 124 of the locking pin 122 may be positioned intermediate a shoulder or shelf 134 defined on the slider 130 and a protrusion 144 extending distally from the firing rod 140 . In other words, when locking pin 122 is positioned intermediate slider 130 and firing rod 140 , locking pin 122 and slider 130 may cooperate to support firing rod 140 against locking shoulder 112 defined in fastener magazine 110 In the upper unlocked position, such that when a distal firing force is applied to the firing rod 140 , the firing rod 140 can advance the sled 130 distally to fire the tack 180 . When tissue thickness compensator 120 is removed from cartridge 110 and/or is substantially disengaged from its desired position relative to the cartridge body, referring primarily to FIG. 45 , locking pin 122 may no longer be positioned intermediate slide 130 and firing member 140, And/or it may not be possible to support the firing member 140 in its unlocked position (FIG. 44). In such circumstances, the firing member 140 can become positioned in the locked position such that distal advancement of the firing member 140 is prevented by the locking shoulder 112 . In at least one such instance, end effector 100 may also include a biasing member, such as a spring, for example, configured to bias firing member 140 into its locked state. In some cases, the biasing member may bias the firing member 140 into contact with the slider 130 , for example, without the locking pin 122 positioned therebetween, which may comprise the locked position of the firing member 140 .
作为以上所述的结果，如果组织厚度补偿件120过早地从仓110移除，则仓110可变得不可操作。在此类情况下，锁定销122可包括熔线，在击发构件140朝远侧推进之前，在组织厚度补偿件120被移除的情况下，该熔线使仓110停用。在各种情况下，锁定销122可包括键，当键定位在滑动件130和击发构件140之间时，该键将仓110维持在解锁状态中，并且在击发构件140朝远侧推进之前，即，在击发构件140开始其击发行程之前，在组织厚度补偿件120从仓110移除的情况下允许仓110进入锁定状态中。当击发构件140处于其锁定状态中并且不能朝远侧推进时，击发构件140的刀刃142不能切入捕获在端部执行器100内的组织。此外，在此类情况下，击发构件140不能将滑动件130朝远侧推进以击发钉180。因此，当组织厚度补偿件120未定位在或未适当地定位在仓110上时，组织厚度补偿件锁定件可防止捕获在端部执行器100内的组织被切入和缝合。在组织厚度补偿件120被移除或脱离之前，在击发构件140朝远侧推进的情况下，击发构件140可完成端部执行器100的击发行程或其击发行程的至少一部分。在此类情况下，滑动件130朝远侧推进，使得限定在滑动件130上的一个或多个斜坡132可提升钉180，并且击发构件140的刀刃142可切入组织厚度补偿件120和/或捕获在端部执行器100内的组织。在一些情况下，击发构件140可接触锁定销122并且在击发构件140朝远侧推进时使其移位离开。在此类情况下，锁定销122可为柔性的。在各种情况下，锁定销122可由例如可生物吸收的材料和/或生物相容性材料构成。在某些情况下，击发构件140可在击发构件140朝远侧推进时切入锁定销122。在任何情况下，一旦击发构件140已至少部分地推进，锁定销122的目的可能变得过时。换句话讲，组织厚度补偿件锁定件可用作初始检查以验证组织厚度补偿件存在于端部执行器内，并且一旦已完成初始检查，便可进行端部执行器的击发行程。As a result of the above, if the tissue thickness compensator 120 is prematurely removed from the cartridge 110, the cartridge 110 may become inoperable. In such cases, locking pin 122 may include a fusible link that deactivates cartridge 110 if tissue thickness compensator 120 is removed prior to distal advancement of firing member 140 . In various instances, locking pin 122 may comprise a key that, when positioned between slide 130 and firing member 140, maintains cartridge 110 in the unlocked state and prior to distal advancement of firing member 140, That is, the cartridge 110 is allowed to enter the locked state with the tissue thickness compensator 120 removed from the cartridge 110 before the firing member 140 begins its firing stroke. When firing member 140 is in its locked state and cannot be advanced distally, cutting edge 142 of firing member 140 cannot cut into tissue captured within end effector 100 . Furthermore, under such circumstances, the firing member 140 is unable to advance the sled 130 distally to fire the staples 180 . Accordingly, the tissue thickness compensator lock may prevent tissue trapped within the end effector 100 from being cut and stapled when the tissue thickness compensator 120 is not positioned or not properly positioned on the cartridge 110 . With firing member 140 advanced distally, firing member 140 may complete a firing stroke of end effector 100 or at least a portion thereof before tissue thickness compensator 120 is removed or disengaged. In such cases, the sled 130 is advanced distally such that the one or more ramps 132 defined on the sled 130 can lift the staples 180 and the blade 142 of the firing member 140 can cut into the tissue thickness compensator 120 and/or Tissue captured within end effector 100. In some cases, firing member 140 may contact locking pin 122 and displace it away as firing member 140 is advanced distally. In such cases, locking pin 122 may be flexible. In various instances, locking pin 122 may be constructed of, for example, a bioabsorbable and/or biocompatible material. In some cases, firing member 140 may cut into locking pin 122 as firing member 140 is advanced distally. In any event, once the firing member 140 has been at least partially advanced, the purpose of the locking pin 122 may become obsolete. In other words, the tissue thickness compensator lock can be used as an initial check to verify that the tissue thickness compensator is present within the end effector, and once the initial check has been completed, the firing stroke of the end effector can be performed.
再次参见图47至图50，端部执行器200可包括砧座260，并且另外包括紧固件仓210，该紧固件仓包括仓体214和组织厚度补偿件220，其中对上文进行进一步描述，组织厚度补偿件220可抵靠由端部执行器200通过可移除地储存在仓体214内的紧固件捕获的组织植入。组织厚度补偿件220可定位在仓体214的顶部表面或平台211上面，其中可移除地储存在限定于仓体214中的钉腔内的钉可由例如击发构件(诸如滑动件230和/或击发构件240)从钉腔射出。在某些实施方案中，紧固件仓210还可包括驱动器，该驱动器被构造成能够支撑钉并且传递滑动件230到钉的运动，以便使钉在未击发位置和击发位置之间运动。在各种情况下，当钉处于其未击发位置中时，钉可至少部分地嵌入组织厚度补偿件220中，而在某些情况下，当钉处于其未击发位置中时，钉可将组织厚度补偿件220保持在适当位置中。在将钉部署到组织中之前，在组织厚度补偿件220相对于仓体214和/或钉运动的情况下，在一些情况下，组织厚度补偿件220可使钉相对于其优选位置运动或远离其优选位置运动。此外，在钉被部署之前，在组织厚度补偿件220从仓210移除的情况下，仓210可能不再适合于其初始预期用途。鉴于以上所述，如下文更详细地讨论，端部执行器200可包括锁定件，该锁定件可被构造成能够在钉被部署之前，在组织厚度补偿件220从仓体214移除或者变得至少部分地从仓体脱离的情况下防止击发构件240和/或滑动件230朝远侧推进以部署钉。Referring again to FIGS. 47-50 , the end effector 200 can include an anvil 260 and additionally include a fastener cartridge 210 including a cartridge body 214 and a tissue thickness compensator 220 , further to the above. As described, tissue thickness compensator 220 may be implanted against tissue captured by end effector 200 via fasteners removably stored within cartridge body 214 . The tissue thickness compensator 220 can be positioned on the top surface or platform 211 of the cartridge body 214, wherein the staples removably stored in the staple cavities defined in the cartridge body 214 can be activated by, for example, a firing member such as the sled 230 and/or Firing member 240) is ejected from the staple cavity. In certain embodiments, the fastener cartridge 210 may also include a driver configured to support the staples and transmit movement of the sled 230 to the staples to move the staples between the unfired and fired positions. In various cases, the staples can be at least partially embedded in the tissue thickness compensator 220 when the staples are in their unfired positions, and in some cases, the staples can insert tissue into the tissue when the staples are in their unfired positions. The thickness compensator 220 remains in place. Upon movement of tissue thickness compensator 220 relative to cartridge body 214 and/or the staples prior to deployment of the staples into tissue, tissue thickness compensator 220 may, in some cases, move or move the staples away from their preferred positions. Its preferred position moves. Furthermore, in the event that tissue thickness compensator 220 is removed from cartridge 210 before the staples are deployed, cartridge 210 may no longer be suitable for its original intended use. In view of the above, and as discussed in greater detail below, end effector 200 can include a lock that can be configured to enable tissue thickness compensator 220 to be removed from cartridge body 214 or changed in place prior to staple deployment. Firing member 240 and/or sled 230 are prevented from advancing distally to deploy the staples if at least partially disengaged from the cartridge body.
再次参见图44至图46，组织厚度补偿件220可包括(一)被构造成能够由钉捕获的主体221，以及(二)从主体221延伸的环或拴系件222。在各种情况下，主要参见图47，环222可包括至少部分地嵌入主体221中的端部以及在端部之间延伸的可与滑动件230可释放地接合的中间部分。在某些情况下，环222可包括例如缝合线或柔性线。在一些情况下，环222可由例如可生物吸收的材料和/或生物相容性材料构成。主要参见图48，滑动件230可包括纵向主体部分236、从主体部分236延伸的钩238，以及限定在主体部分236和钩238之间的狭槽237。如图48所示，当组织厚度补偿件220定位在仓平台211上方时，环222定位在狭槽237内，并且滑动件230和击发构件240处于未击发位置中。另外如图48所示，从击发构件240延伸的远侧突起244抵靠限定在滑动件230上的支撑肩部234定位并且/或者定位在其上，该支撑肩部将击发构件240保持在解锁位置中，即保持在这样的位置中，在该位置中，当击发运动施加到击发构件240时，击发构件240的远侧运动将被限定在端部执行器200中的锁定肩部212阻碍或至少基本上阻碍。因此，当滑动件230将击发构件240保持在其解锁位置中时，参见图49，击发构件240将滑动经过锁定肩部212以将滑动件230朝远侧推进，击发可移除地储存在仓体214内的钉，并且用刀刃242切入组织厚度补偿件和定位在端部执行器200内的组织。如图49所示，当滑动件230朝远侧推进时，环222可滑动退出限定于滑动件230中的狭槽237。Referring again to FIGS. 44-46 , tissue thickness compensator 220 may include (a) a body 221 configured to be captured by staples, and (ii) a loop or tether 222 extending from body 221 . In various cases, referring primarily to FIG. 47 , the ring 222 can include end portions at least partially embedded within the body 221 and an intermediate portion extending between the ends that can releasably engage the slider 230 . In some cases, loop 222 may comprise suture or flexible wire, for example. In some cases, ring 222 may be constructed of, for example, a bioabsorbable material and/or a biocompatible material. Referring primarily to FIG. 48 , slider 230 may include a longitudinal body portion 236 , a hook 238 extending from body portion 236 , and a slot 237 defined between body portion 236 and hook 238 . As shown in FIG. 48 , when tissue thickness compensator 220 is positioned above cartridge deck 211 , ring 222 is positioned within slot 237 and sled 230 and firing member 240 are in the unfired position. As also shown in FIG. 48 , a distal protrusion 244 extending from the firing member 240 is positioned against and/or on a support shoulder 234 defined on the slider 230 that holds the firing member 240 in the unlocked position. position, that is, maintained in such a position, in this position, when the firing motion is applied to the firing member 240, the distal movement of the firing member 240 will be defined in the end effector 200 in the locking shoulder 212 hinder or At least basically hinder. Thus, when the slide 230 holds the firing member 240 in its unlocked position, see FIG. 49 , the firing member 240 will slide past the locking shoulder 212 to advance the slide 230 distally, and the firing is removably stored in the cartridge. The staples within the body 214 are inserted and the blade 242 is used to cut into the tissue thickness compensator and tissue positioned within the end effector 200 . As shown in FIG. 49 , ring 222 can slide out of slot 237 defined in sled 230 as sled 230 is advanced distally.
在组织厚度补偿件220从仓210移除或基本上从仓210的平台211上方的合适位置运动的情况下，现在参见图50，组织厚度补偿件220可将滑动件230朝远侧牵拉，使得击发构件240不再由滑动件230支撑。更具体地，组织厚度补偿件220的定位在狭槽237内的环222可将滑动件230从其未击发位置朝远侧牵拉，使得支撑肩部234不再定位在击发构件240的远侧突起244下面。在此类情况下，击发构件240可向下移位到锁定位置中，其中击发构件240的远侧运动可被锁定肩部212妨碍。在某些情况下，端部执行器200还可包括可将击发构件240偏压到其锁定状态中的偏压构件，诸如弹簧。当击发构件240处于其锁定状态中时，击发构件240不能朝远侧运动以推进滑动件230，将钉从仓体210击发，以及/或者切入捕获在端部执行器200内的组织。虽然当组织厚度补偿件220从仓210移除时滑动件230可朝远侧推进，但在各种情况下，滑动件230可能不会充分地推进以从仓210部署钉。当外科器械的使用者认识到击发构件240处于锁定状态中时，使用者可将钉仓210从端部执行器200移除并且将其替换为例如钉仓210，其中组织厚度补偿件220正确定位在平台211上方并且滑动件230尚未从其未击发位置朝远侧推进。可以设想到其他实施方案，其中钉仓不可从端部执行器移除，在此类实施方案中，在组织厚度补偿件从钉仓移除并且/或者击发构件进入锁定状态中的情况下，端部执行器可被完全替换。With tissue thickness compensator 220 removed from cartridge 210 or moved substantially from an appropriate position above deck 211 of cartridge 210, referring now to FIG. 50, tissue thickness compensator 220 may pull sled 230 distally, Such that the firing member 240 is no longer supported by the slider 230 . More specifically, ring 222 of tissue thickness compensator 220 positioned within slot 237 can pull sled 230 distally from its unfired position such that support shoulder 234 is no longer positioned distally of firing member 240 protrusion 244 below. In such circumstances, the firing member 240 can be displaced downward into the locked position, wherein distal movement of the firing member 240 can be impeded by the locking shoulder 212 . In some cases, end effector 200 may also include a biasing member, such as a spring, that may bias firing member 240 into its locked state. When firing member 240 is in its locked state, firing member 240 cannot move distally to advance sled 230 , fire staples from cartridge body 210 , and/or cut into tissue captured within end effector 200 . While sled 230 may be advanced distally when tissue thickness compensator 220 is removed from cartridge 210 , in various circumstances, sled 230 may not be advanced sufficiently to deploy staples from cartridge 210 . When the user of the surgical instrument recognizes that firing member 240 is in the locked state, the user can remove staple cartridge 210 from end effector 200 and replace it with, for example, staple cartridge 210 with tissue thickness compensator 220 properly positioned. Above platform 211 and sled 230 has not been advanced distally from its unfired position. Other embodiments can be envisaged wherein the staple cartridge is not removable from the end effector, and in such embodiments, the end effector is activated when the tissue thickness compensator is removed from the staple cartridge and/or the firing member enters a locked state. External actuators can be completely replaced.
现在转到图51至图53，钉仓310可包括仓体314和可动地定位在仓体314内的滑动件330。类似于上文，仓体314可包括例如多个紧固件腔，诸如紧固件腔316，以及例如限定在其中的纵向狭槽，诸如刀狭槽318。滑动件330可包括可滑动地定位在刀狭槽318内的中心主体部分336以及从中心主体部分336延伸的钩338。主要参见图51，仓310的组织厚度补偿件320可包括主体部分321以及从主体部分321延伸的扣件322，其中当滑动件330处于其未击发或未推进位置中时，扣件322可以可释放地保持在限定于钩338和中心主体部分336之间的狭槽337中。类似于上文，扣件322可包括安装在主体321内的端部323并且可从组织厚度补偿件320的主体321朝近侧延伸，其中在例如组织厚度补偿件320从仓体314移除的情况下，扣件322可将滑动件330朝远侧牵拉，使得限定在中心主体部分336中的支撑肩部334不再能够在其上支撑击发构件(诸如击发构件240)，并且使得击发构件可进入锁定状态。在各种情况下，外科器械的使用者可尝试将组织厚度补偿件320重新组装或重新定位在仓体314的平台311上方；然而，由于组织厚度补偿件320的重新定位将不会重置滑动件330，所以击发构件340将仍保持在锁定状态中。因此，此类布置可防止仓310在其已被篡改的情况下被使用。Turning now to FIGS. 51-53 , a staple cartridge 310 can include a cartridge body 314 and a sled 330 movably positioned within the cartridge body 314 . Similar to the above, the cartridge body 314 may include, for example, a plurality of fastener cavities, such as fastener cavities 316 , and, for example, longitudinal slots, such as knife slots 318 , defined therein. Slider 330 may include a central body portion 336 slidably positioned within knife slot 318 and a hook 338 extending from central body portion 336 . Referring primarily to FIG. 51 , the tissue thickness compensator 320 of the cartridge 310 can include a body portion 321 and a clasp 322 extending from the body portion 321 , wherein the clasp 322 can be actuated when the slider 330 is in its unfired or unadvanced position. Releasably retained in a slot 337 defined between the hook 338 and the central body portion 336 . Similar to the above, the clasp 322 can include an end 323 mounted within the body 321 and can extend proximally from the body 321 of the tissue thickness compensator 320 where, for example, the tissue thickness compensator 320 is removed from the cartridge body 314 In this case, the clasp 322 can pull the slider 330 distally so that the support shoulder 334 defined in the central body portion 336 can no longer support a firing member (such as the firing member 240) thereon, and the firing member Can enter the locked state. In various circumstances, the user of the surgical instrument may attempt to reassemble or reposition the tissue thickness compensator 320 above the platform 311 of the cartridge body 314; however, the repositioning of the tissue thickness compensator 320 will not reset the slide 330, so the firing member 340 will remain in the locked state. Accordingly, such an arrangement prevents the cartridge 310 from being used if it has been tampered with.
在各种情况下，再次参见图51至图53，从滑动件330和/或狭槽337的中心部分336延伸的限定在其间的钩338的至少一部分可延伸到平台311上方。在某些情况下，从滑动件330和/或狭槽337的中心部分336延伸的限定在其间的钩338的至少一部分可延伸到刀狭槽318上方。在此类实施方案中，当组织厚度补偿件320被组装到仓体314时，扣件322可易于滑动到狭槽337中。在某些情况下，扣件322可定位在仓体314的平台表面311上方或抵靠其定位。在各种情况下，主要参见图53，仓体314可包括限定在其中的凹陷部或凹坑319，当滑动件330处于其未击发或未推进位置中时，钩338可定位在所述凹陷部或凹坑内。在这样的实施方案中，钩338的顶部可被定位在平台表面311下方。在各种情况下，凹坑319还可包括限定在凹坑319的远侧端部中的一个或多个倾斜表面313，并且从平台表面311向下延伸。在一些情况下，当滑动件330朝远侧推进时，扣件322可邻接倾斜表面313，在此类情况下，钩338然后可与扣件322分离。在各种情况下，凹陷部319可被构造成能够有利于在组织厚度补偿件320被组装到仓体314时将扣件322组装到滑动件330。在各种实施方案中，狭槽337可纵向地延伸并且可包括闭合的远侧端部和开放的近侧端部，其中扣件322可从开放的近侧端部滑动到狭槽337中。在组织厚度补偿件320没有过早地从仓314移除或脱离的情况下，滑动件330可朝远侧推进，使得扣件322穿过其远侧端部离开狭槽337并且使得限定在滑动件330上的斜坡332可将钉从钉仓310射出。In various cases, referring again to FIGS. 51-53 , at least a portion of the hook 338 defined therebetween extending from the slider 330 and/or the central portion 336 of the slot 337 may extend above the platform 311 . In some cases, at least a portion of the hook 338 defined therebetween extending from the slider 330 and/or the central portion 336 of the slot 337 may extend above the knife slot 318 . In such embodiments, the clasp 322 can be easily slid into the slot 337 when the tissue thickness compensator 320 is assembled to the cartridge body 314 . In some cases, the clasp 322 may be positioned above or against the deck surface 311 of the cartridge body 314 . In various cases, referring primarily to FIG. 53 , the cartridge body 314 can include a recess or pocket 319 defined therein into which the hook 338 can be positioned when the slide 330 is in its unfired or unpropelled position. part or pit. In such an embodiment, the top of hook 338 may be positioned below deck surface 311 . In various cases, the dimple 319 may also include one or more sloped surfaces 313 defined in the distal end of the dimple 319 and extending downwardly from the deck surface 311 . In some cases, catch 322 may abut sloped surface 313 as sled 330 is advanced distally, in which case hook 338 may then disengage from catch 322 . In various circumstances, recess 319 can be configured to facilitate assembly of clasp 322 to sled 330 when tissue thickness compensator 320 is assembled to cartridge body 314 . In various embodiments, the slot 337 can extend longitudinally and can include a closed distal end and an open proximal end, wherein the clasp 322 can slide into the slot 337 from the open proximal end. In the event that the tissue thickness compensator 320 is not prematurely removed or disengaged from the cartridge 314, the slider 330 can be advanced distally so that the clasp 322 exits the slot 337 through its distal end and is limited in the sliding position. Ramp 332 on member 330 ejects the staples from cartridge 310.
在各种情况下，可使用至少一种粘合剂将组织厚度补偿件粘附到滑动件。在此类情况下，组织厚度补偿件和滑动件之间的粘合剂附接可足够强以允许组织厚度补偿件在组织厚度补偿件从仓移除的情况下将滑动件朝远侧牵拉。当滑动件被击发构件朝远侧推进作为击发行程的一部分时，组织厚度补偿件和滑动件之间的粘合剂附接可能失败，从而允许滑动件相对于组织厚度补偿件朝远侧滑动。在各种情况下，组织厚度补偿件可使用热熔接工艺和/或热成形工艺结合到滑动件。在此类情况下，组织厚度补偿件和滑动件之间的结合可足够强以允许组织厚度补偿件在组织厚度补偿件从仓移除的情况下将滑动件朝远侧牵拉。当滑动件被击发构件朝远侧推进作为击发行程的一部分时，组织厚度补偿件和滑动件之间的结合可能失败，从而允许滑动件相对于组织厚度补偿件朝远侧滑动。In each case, at least one adhesive can be used to adhere the tissue thickness compensator to the slide. In such cases, the adhesive attachment between the tissue thickness compensator and the sled may be sufficiently strong to allow the tissue thickness compensator to pull the sled distally if the tissue thickness compensator is removed from the cartridge . When the sled is advanced distally by the firing member as part of the firing stroke, the adhesive attachment between the tissue thickness compensator and the sled may fail, allowing the sled to slide distally relative to the tissue thickness compensator. In various cases, the tissue thickness compensator can be bonded to the slide using a heat welding process and/or a thermoforming process. In such cases, the bond between the tissue thickness compensator and the sled may be sufficiently strong to allow the tissue thickness compensator to pull the sled distally if the tissue thickness compensator is removed from the cartridge. When the sled is advanced distally by the firing member as part of the firing stroke, the bond between the tissue thickness compensator and the sled may fail, allowing the sled to slide distally relative to the tissue thickness compensator.
在一些情况下，例如，环、扣件和/或标签可与组织厚度补偿件一体形成。在各种情况下，例如，环、扣件和/或标签可包括与组织厚度补偿件一体的材料。在一些情况下，可将附加的层附接到组织厚度补偿件。在各种情况下，该层可包括与滑动件接合的安装部分。In some cases, for example, loops, fasteners, and/or labels may be integrally formed with the tissue thickness compensator. In various instances, for example, the loops, fasteners and/or tags may comprise material integral with the tissue thickness compensator. In some cases, additional layers may be attached to the tissue thickness compensator. In various cases, the layer may include a mounting portion that engages the slider.
现在转到图54，类似于上文，滑动件430可包括中心主体部分436，并且另外包括多个斜坡432，所述斜坡被构造成能够例如将可移除地储存在仓体内的钉射出。同样类似于上文，主体部分436可包括从该主体部分延伸的钩438，其中狭槽437可限定在主体部分436和钩438之间。在某些情况下，狭槽437可包括闭合的远侧端部437a和开放的近侧端部437d。在各种情况下，狭槽437还可包括沿第一方向延伸的第一部分437b以及沿第二方向延伸的第二部分437c。在某些情况下，第一部分437b可沿纵向轴线延伸并且第二部分437可沿横向于纵向轴线的第二轴线延伸。在至少一种此类情况下，第二部分437c可相对于第一部分437b成角度延伸。Turning now to FIG. 54 , similar to the above, a slide 430 may include a central body portion 436 and additionally include a plurality of ramps 432 configured to eject staples removably stored within the cartridge, for example. Also similar to the above, the body portion 436 may include a hook 438 extending therefrom, wherein the slot 437 may be defined between the body portion 436 and the hook 438 . In some cases, the slot 437 can include a closed distal end 437a and an open proximal end 437d. In various cases, the slot 437 may also include a first portion 437b extending in the first direction and a second portion 437c extending in the second direction. In some cases, the first portion 437b can extend along the longitudinal axis and the second portion 437 can extend along a second axis transverse to the longitudinal axis. In at least one such case, the second portion 437c can extend at an angle relative to the first portion 437b.
现在转到图55至图58，滑动件组件530可包括第一部分535，并且另外包括第二部分536，该第二部分可相对于第一部分535在解锁位置(图55和图57)和锁定位置(图56和图58)之间运动。第一部分535可包括(一)被构造成能够在纵向狭槽(诸如限定在钉仓510中的刀狭槽518)内滑动的中心部分，以及(二)被构造成能够将可移除地储存在仓510内的钉射出的多个斜坡532。第一部分535的中心部分可包括限定在其中的第一狭槽533a和第二狭槽533b。第一狭槽533a和第二狭槽533b可被构造成能够接收分别从第二部分536延伸的销531a和531b。第一销531a可被构造成能够在第一狭槽533a内滑动，并且第二销531b可被构造成能够在第二狭槽533b内滑动，以便允许第二部分536相对于第一部分535旋转。在各种情况下，第一销531a可紧密地接收在第一狭槽533a内，使得第一狭槽533a可约束第一销531a沿第一路径的运动，并且类似地，第二销531b可紧密地接收在第二狭槽533b内，使得第二狭槽533b可约束第二销531b沿第二路径的运动。主要参见图57，滑动件组件530的第二部分536可包括被构造成能够在刀狭槽518内滑动的臂，其中臂可包括限定在其近侧端部上的支撑肩部534以及限定在其远侧端部上的钩538。类似于上文，支撑肩部534可被构造成能够在滑动件组件530处于近侧未击发位置中并且组织厚度补偿件220例如在仓510的平台表面511上方或抵靠其定位时将击发构件240支撑在例如解锁位置中。同样类似于上文，钩538可被构造成能够可释放地保持组织厚度补偿件220的环222，使得在组织厚度补偿件220从仓体移除并且/或者基本上相对于仓体移位的情况下，环222可牵拉到第二部分536上以将第二部分536枢转到其锁定位置中，如图58所示。在第二部分536的此类锁定位置中，支撑肩部534可不再支撑击发构件240的远侧突起244，并且击发构件240可向下落入其锁定位置中。如图58所示，第二部分536到其锁定位置中的旋转可使支撑肩部534朝远侧运动并且/或者向下运动远离击发构件240。同样如图58所示，击发构件240可包括从其相对侧延伸的锁541，该锁可被构造成能够在击发构件240处于其锁定位置中时邻接锁定肩部212。当击发构件240被滑动件组件530保持在其解锁位置中时，锁541可不接触锁定肩部212并且击发构件240可被推进穿过仓510。Turning now to FIGS. 55-58 , the slider assembly 530 can include a first portion 535 and additionally include a second portion 536 that can be positioned relative to the first portion 535 in an unlocked position ( FIGS. 55 and 57 ) and a locked position. (Figure 56 and Figure 58). First portion 535 may include (a) a central portion configured to slide within a longitudinal slot, such as knife slot 518 defined in staple cartridge 510, and (ii) configured to be removably stored. A plurality of ramps 532 for staple firing within the cartridge 510 . The central portion of the first portion 535 may include a first slot 533a and a second slot 533b defined therein. First slot 533a and second slot 533b may be configured to receive pins 531a and 531b respectively extending from second portion 536 . The first pin 531a can be configured to slide within the first slot 533a and the second pin 531b can be configured to slide within the second slot 533b so as to allow the second portion 536 to rotate relative to the first portion 535 . In various circumstances, the first pin 531a can be tightly received within the first slot 533a, such that the first slot 533a can constrain the movement of the first pin 531a along the first path, and similarly, the second pin 531b can Tightly received within the second slot 533b such that the second slot 533b constrains movement of the second pin 531b along the second path. Referring primarily to FIG. 57 , the second portion 536 of the slider assembly 530 can include an arm configured to slide within the knife slot 518, wherein the arm can include a support shoulder 534 defined on a proximal end thereof and a support shoulder 534 defined on a proximal end thereof. Hook 538 on its distal end. Similar to the above, the support shoulder 534 can be configured to hold the firing member when the sled assembly 530 is in the proximal unfired position and the tissue thickness compensator 220 is positioned above or against the deck surface 511 of the cartridge 510, for example. 240 is supported eg in an unlocked position. Also similar to the above, the hook 538 can be configured to releasably retain the loop 222 of the tissue thickness compensator 220 such that when the tissue thickness compensator 220 is removed from the cartridge body and/or is substantially displaced relative to the cartridge body In this case, the loop 222 can be pulled over the second portion 536 to pivot the second portion 536 into its locked position, as shown in FIG. 58 . In such a locked position of the second portion 536, the support shoulder 534 can no longer support the distal protrusion 244 of the firing member 240, and the firing member 240 can drop down into its locked position. As shown in FIG. 58 , rotation of second portion 536 into its locked position can move support shoulder 534 distally and/or downwardly away from firing member 240 . As also shown in FIG. 58 , the firing member 240 can include a lock 541 extending from an opposite side thereof, which can be configured to abut the locking shoulder 212 when the firing member 240 is in its locked position. When the firing member 240 is held in its unlocked position by the slider assembly 530 , the lock 541 may not contact the locking shoulder 212 and the firing member 240 may be advanced through the cartridge 510 .
在各种情况下，如上所述，钉驱动滑动件的一部分可延伸到仓体的平台表面上方。例如，再次参见图52和图54，例如滑动件330(图52)的钩338和/或滑动件430的钩438可延伸到平台表面上方。在此类情况下，钩338和/或钩438可在平台表面上方朝远侧平移，并且在一些情况下，接触抵靠平台表面定位或定位在平台表面上方的组织厚度补偿件。在某些情况下，钩338和/或钩438可将组织厚度补偿件向上提升远离仓体并且有利于将组织厚度补偿件从仓逐渐释放。例如，钩338和/或钩438可开始于组织厚度补偿件的近侧端部并且朝组织厚度补偿件的远侧端部运动，以便最初提升组织厚度补偿件的近侧端部，并且然后将其逐渐提升远离仓平台直到组织厚度补偿件的远侧端部最终提升远离仓体。在其他情况下，如下文进一步更详细地讨论，对于滑动件的接触组织厚度补偿件的部分可能优选的是向下偏转并且/或者以其他方式在滑动件朝远侧推进时不干扰组织厚度补偿件。In various instances, as described above, a portion of the staple driving sled can extend above the deck surface of the cartridge body. For example, referring again to FIGS. 52 and 54 , for example, hook 338 of slider 330 ( FIG. 52 ) and/or hook 438 of slider 430 may extend above the deck surface. In such cases, hooks 338 and/or hooks 438 may translate distally above the deck surface and, in some cases, contact a tissue thickness compensator positioned against or above the deck surface. In some cases, hooks 338 and/or hooks 438 may lift the tissue thickness compensator up and away from the cartridge body and facilitate gradual release of the tissue thickness compensator from the cartridge. For example, hook 338 and/or hook 438 may start at the proximal end of the tissue thickness compensator and move toward the distal end of the tissue thickness compensator to initially lift the proximal end of the tissue thickness compensator and then move It is gradually lifted away from the cartridge deck until the distal end of the tissue thickness compensator is finally lifted away from the cartridge body. In other cases, as discussed in more detail further below, it may be preferable for the portion of the sled that contacts the tissue thickness compensator to deflect downward and/or otherwise not interfere with tissue thickness compensation as the sled is advanced distally. pieces.
现在转向图59和图60，钉仓610可包括仓体614、可释放地保持到仓体614的组织厚度补偿件620，以及被构造成能够纵向横贯仓体614并且射出可移除地储存在仓体中的钉的滑动件630。滑动件630可包括具有限定在其上的多个斜坡表面的主要主体部分635、支撑肩部634，以及从主体部分635延伸的臂636。在各种情况下，臂636可被组装到主要主体部分635。例如，臂636可包括例如嵌入主要主体部分635中的第一端部以及包括钩638的第二端部。在各种情况下，臂636可包括从主要主体部分635延伸的悬臂梁。在某些情况下，臂636可由例如弹性和/或柔性的材料构成。类似于上文，狭槽637可限定在钩638和臂636之间，其可被构造成能够在滑动件630处于其近侧未击发位置中时可释放地保持组织厚度补偿件620的一部分。例如，在组织厚度补偿件620被拉离仓体614的情况下，组织厚度补偿件620可将滑动件630朝远侧牵拉远离击发构件，使得击发构件进入到锁定状态中。Turning now to FIGS. 59 and 60 , a staple cartridge 610 can include a cartridge body 614 , a tissue thickness compensator 620 releasably retained to the cartridge body 614 , and a tissue thickness compensator 620 configured to longitudinally traverse the cartridge body 614 and ejected to be removably stored in the cartridge body 614 . Slider 630 for staples in the cartridge body. Slider 630 may include a main body portion 635 having a plurality of ramped surfaces defined thereon, a support shoulder 634 , and an arm 636 extending from body portion 635 . In various cases, arm 636 may be assembled to main body portion 635 . For example, arm 636 may include a first end, eg, embedded in main body portion 635 , and a second end including hook 638 . In various cases, arm 636 may comprise a cantilever beam extending from main body portion 635 . In some cases, arms 636 may be constructed of resilient and/or flexible materials, for example. Similar to the above, a slot 637 can be defined between the hook 638 and the arm 636, which can be configured to releasably retain a portion of the tissue thickness compensator 620 when the sled 630 is in its proximal unfired position. For example, with the tissue thickness compensator 620 pulled away from the cartridge body 614, the tissue thickness compensator 620 can pull the sled 630 distally away from the firing member such that the firing member enters the locked state.
在各种情况下，对上文进行进一步描述，臂636的至少一部分(诸如钩638)可延伸到仓体614的平台表面611上方。在某些情况下，当滑动件630处于其近侧位置(图59)中时，臂636可与例如从组织厚度补偿件620延伸的环接合，并且在滑动件630朝远侧推进时，臂636可与环脱离接合。在滑动件630朝远侧推进时，在某些情况下，臂636可接触组织厚度补偿件620的主体部分621并且向下挠曲。在各种情况下，在滑动件630朝远侧推进时，偏转的臂636可在限定于仓体614中的纵向刀狭槽618内滑动。在一些情况下，参见图60，纵向狭槽618的远侧端部可由鼻壁或屋顶619限定，其中当滑动件630到达仓610的远侧端部617时，臂636可在鼻壁619下面滑动，使得端部执行器的击发行程可完成。在一些情况下，臂636可能不通过组织厚度补偿件620向下偏转或基本上向下偏转，其中当臂636到达纵向狭槽618的端部时，臂636可接触鼻壁618并且向下挠曲以便在其下滑动，如图60所示。在各种情况下，作为结果，柔性臂636可允许击发行程完成并且滑动件630停放在仓的远侧端部处。In various cases, further to the above, at least a portion of the arm 636 , such as the hook 638 , can extend above the deck surface 611 of the cartridge body 614 . In some cases, when the sled 630 is in its proximal position ( FIG. 59 ), the arms 636 can engage, for example, a ring extending from the tissue thickness compensator 620 , and as the sled 630 is advanced distally, the arms 636 636 is disengageable from the ring. As the sled 630 is advanced distally, the arms 636 may contact the body portion 621 of the tissue thickness compensator 620 and deflect downwardly under certain circumstances. In various circumstances, the deflected arm 636 can slide within the longitudinal knife slot 618 defined in the cartridge body 614 as the sled 630 is advanced distally. In some cases, referring to FIG. 60 , the distal end of the longitudinal slot 618 can be defined by a nose wall or roof 619 , wherein when the slider 630 reaches the distal end 617 of the cartridge 610 , the arm 636 can be below the nose wall 619 slide, allowing the firing stroke of the end effector to be completed. In some cases, arm 636 may not be deflected downwardly or substantially downwardly by tissue thickness compensator 620, wherein when arm 636 reaches the end of longitudinal slot 618, arm 636 may contact nasal wall 618 and deflect downwardly. curve to slide under it, as shown in Figure 60. In various circumstances, as a result, the flexible arm 636 can allow the firing stroke to complete and the sled 630 to park at the distal end of the cartridge.
现在转到图61，滑动件诸如滑动件组件730例如可包括主要主体部分735和可动臂736。类似于上文，主要主体部分735可包括一个或多个钉驱动斜坡732以及被构造成能够将击发构件支撑在解锁位置中的支撑肩部734，如上所述。臂736可包括第一端部和第二端部，该第一端部可枢转和/或可旋转地安装到主要主体部分735，该第二端部包括被构造成能够与组织厚度补偿件可释放地接合的钩738，如上所述。当滑动件组件730朝远侧推进时，钩738可从组织厚度补偿件分离；然而，钩738的上部表面可保持与组织厚度补偿件的底部表面接触。在此类情况下，臂736可例如向下枢转到刀狭槽318中，以便在组织厚度补偿件下面滑动。更具体地，臂736可从升高或凸起的最上面位置(图61)枢转到降低或凹陷的位置。在各种情况下，滑动件组件730还可包括例如被构造成能够将臂736偏压到其凸起位置中的弹性偏压构件，诸如弹簧731。当臂736已向下旋转到其降低位置中时，弹簧731可向臂736施加偏压力，该臂被传递到组织厚度补偿件中。在某些情况下，弹簧731可被定位在臂736和限定在主要主体部分735上的框架部分733中间。在各种情况下，弹簧731可包括例如从臂736延伸的悬臂弹簧或片簧。当臂736向下推动时，悬臂弹簧可被构造成能够沿例如框架部分731挠曲和/或滑动。在各种实施方案中，主要主体部分735还可包括例如止动肩部739，该止动肩部可限制臂736的向上旋转或行进。在任何情况下，类似于上文，臂736可被构造成能够在其接触屋顶619并且允许击发行程完成时向下旋转。Turning now to FIG. 61 , a slider such as slider assembly 730 , for example, can include a main body portion 735 and a movable arm 736 . Similar to the above, the main body portion 735 may include one or more staple driving ramps 732 and support shoulders 734 configured to support the firing member in the unlocked position, as described above. The arm 736 may include a first end pivotally and/or rotatably mounted to the main body portion 735 and a second end including a tissue thickness compensator configured to engage Releasably engageable hook 738, as described above. As the sled assembly 730 is advanced distally, the hook 738 can disengage from the tissue thickness compensator; however, the upper surface of the hook 738 can remain in contact with the bottom surface of the tissue thickness compensator. In such cases, the arm 736 may, for example, pivot downward into the knife slot 318 to slide under the tissue thickness compensator. More specifically, the arm 736 is pivotable from a raised or raised uppermost position (FIG. 61) to a lowered or recessed position. In various cases, slider assembly 730 may also include a resilient biasing member, such as spring 731 , for example, configured to bias arm 736 into its raised position. When the arm 736 has been rotated downward into its lowered position, the spring 731 can apply a biasing force to the arm 736 which is transmitted into the tissue thickness compensator. In some cases, spring 731 may be positioned intermediate arm 736 and frame portion 733 defined on main body portion 735 . In various cases, spring 731 may comprise, for example, a cantilever spring or a leaf spring extending from arm 736 . The cantilever spring may be configured to flex and/or slide along, for example, the frame portion 731 when the arm 736 is pushed downward. In various embodiments, the main body portion 735 can also include, for example, a stop shoulder 739 that can limit upward rotation or travel of the arm 736 . In any event, similar to the above, the arm 736 can be configured to be able to rotate downward when it contacts the roof 619 and allows the firing stroke to complete.
在各种情况下，钉可包括基部以及从基部延伸的一个或多个腿。在某些情况下，钉可包括具有第一端部和第二端部的基部、从第一端部延伸的第一腿，以及从第二端部延伸的第二腿。在一些情况下，钉可由包括第一腿、基部和第二腿的连续线形成。连续线的第一端部可包括第一钉腿的尖端，并且连续线的第二端部可包括第二钉腿的尖端。一个此类钉，即钉800示于例如图62中。钉800可包括基部802、从基部802的第一端部延伸的第一钉腿804，以及从基部802的第二端部延伸的第二钉腿804。第一钉腿804可包括第一尖端806，并且类似地，第二钉腿804可包括第二尖端806。在各种情况下，尖端806可被构造成能够穿透组织，诸如示于例如图62中的组织T。在一些情况下，尖端806可为锋利的，并且可通过例如模压工艺来形成。在各种实施方案中，线可由例如钛和/或不锈钢构成。In various cases, the staple can include a base and one or more legs extending from the base. In some cases, the staple can include a base having a first end and a second end, a first leg extending from the first end, and a second leg extending from the second end. In some cases, a staple may be formed from a continuous line including a first leg, a base, and a second leg. The first end of the continuous thread may include the tip of the first staple leg, and the second end of the continuous thread may include the tip of the second staple leg. One such staple, staple 800, is shown, for example, in FIG. 62 . The staple 800 can include a base 802 , a first staple leg 804 extending from a first end of the base 802 , and a second staple leg 804 extending from a second end of the base 802 . The first staple leg 804 can include a first tip 806 and similarly, the second staple leg 804 can include a second tip 806 . In various circumstances, tip 806 can be configured to penetrate tissue, such as tissue T shown in, for example, FIG. 62 . In some cases, tip 806 may be sharp and may be formed by, for example, a molding process. In various embodiments, the wire can be composed of titanium and/or stainless steel, for example.
在各种实施方案中，钉800例如在其处于其未成形构型中时可为U形形状或至少基本上U形形状的。在此类实施方案中，钉800的腿804可彼此平行或至少基本上彼此平行。此外，在此类实施方案中，腿804可垂直于或者至少基本上垂直于基部802。在某些实施方案中，钉800例如在其处于其未成形构型中时可为V形形状或至少基本上V形形状的。在此类实施方案中，钉800的腿804不是彼此平行的；相反，腿804可沿非平行方向延伸。此外，在此类实施方案中，腿804中的一个或两个不垂直于基部802，其中腿804中的一个或两个可沿倾斜于基部802的方向延伸。在各种情况下，腿804可相对于钉的中心或中线向外延伸或张开。在任何情况下，钉800可以可移除地储存在钉仓内，从钉仓射出以刺透组织，如图62所示，然后接触定位在组织的相对侧上的砧座。砧座可被构造成能够使钉800变形成任何合适的形状，诸如B形式构型，例如同样如图62所示。各种成形的钉构型诸如B形式构型可限定组织截留区域，诸如组织截留区域807，该组织截留区域被构造成能够将组织截留在钉内。In various embodiments, the staple 800 can be U-shaped or at least substantially U-shaped, eg, when it is in its unformed configuration. In such embodiments, the legs 804 of the staple 800 can be parallel or at least substantially parallel to each other. Furthermore, in such embodiments, the legs 804 can be perpendicular, or at least substantially perpendicular, to the base 802 . In certain embodiments, staple 800 can be V-shaped, or at least substantially V-shaped, eg, when it is in its unformed configuration. In such embodiments, the legs 804 of the staples 800 are not parallel to each other; instead, the legs 804 may extend in non-parallel directions. Furthermore, in such embodiments, one or both of the legs 804 are not perpendicular to the base 802 , wherein one or both of the legs 804 may extend in a direction oblique to the base 802 . In various instances, the legs 804 can extend or flare outward relative to the center or midline of the staple. In any event, staples 800 can be removably stored within a staple cartridge, fired from the staple cartridge to penetrate tissue, as shown in FIG. 62, and then contact an anvil positioned on the opposite side of the tissue. The anvil may be configured to deform the staple 800 into any suitable shape, such as a B-form configuration, such as also shown in FIG. 62 , for example. Various shaped staple configurations, such as the B-form configuration, can define tissue entrapment regions, such as tissue entrapment region 807, configured to trap tissue within the staple.
如上所述，钉可以可移除地储存在限定于仓体中的腔内。仓体810示于图63中，其可包括限定于其中的一个或多个钉腔812。参见图63、图68和图69，每个钉腔812可包括第一端部814和第二端部814。在某些实施方案诸如包括纵向端部执行器的实施方案中，例如，第一端部814可包括钉腔812的近侧端部并且第二端部814可包括钉腔812的远侧端部。在各种情况下，钉可定位在钉腔812内，使得钉800的第一腿804定位在钉腔812的第一端部814中，并且第二腿804定位在第二端部814中。在各种情况下，钉腔宽度可限定在钉腔812的端部814之间。钉的基部802可由基部宽度限定，该基部宽度等于或短于例如钉腔宽度。在某些情况下，钉可具有可限定在钉腿804的尖端806之间的钉宽度。在一些实施方案中，钉宽度可等于钉腔宽度。在各种实施方案中，钉宽度可宽于钉腔宽度。在此类实施方案中，腿804可与钉腔812的端部814接触并且可在钉定位在钉腔812内时由端部814向内弹性偏压。当钉被向上提升出钉腔812时，腿804可在其从钉腔812出现时向外弹性地展开。例如，钉可定位在钉腔812内，使得当钉处于其未击发或未提升位置中时，钉腿804的尖端806不延伸到仓体810的顶部表面或平台上方。在这样的位置中，尖端806可被定位成与仓体810的平台811齐平或凹陷到该平台下方。另选地，腿804的尖端806可至少部分地延伸到仓体810的平台811上方。在任何情况下，在钉向上提升时，钉尖端806可出现在平台811上方并且在腿804从腔812出现时向外展开。在钉的提升期间的某些时候，腿804可能不再与钉腔812的端部814接触，并且腿804可不再由钉腔812的侧壁向内偏压。As noted above, the staples may be removably stored within cavities defined in the cartridge body. Cartridge body 810, shown in FIG. 63, can include one or more staple cavities 812 defined therein. Referring to FIGS. 63 , 68 and 69 , each staple cavity 812 can include a first end 814 and a second end 814 . In certain embodiments, such as embodiments comprising a longitudinal end effector, for example, first end 814 can comprise a proximal end of staple cavity 812 and second end 814 can comprise a distal end of staple cavity 812 . In various circumstances, a staple can be positioned within staple cavity 812 such that first leg 804 of staple 800 is positioned in first end 814 of staple cavity 812 and second leg 804 is positioned in second end 814 . In various circumstances, the staple cavity width can be defined between the ends 814 of the staple cavity 812 . The base 802 of the staple may be defined by a base width that is equal to or shorter than, for example, the staple cavity width. In some cases, the staples can have a staple width that can be defined between the tips 806 of the staple legs 804 . In some embodiments, the staple width can be equal to the staple cavity width. In various embodiments, the staple width can be wider than the staple cavity width. In such embodiments, the legs 804 can be in contact with the ends 814 of the staple cavities 812 and can be resiliently biased inwardly by the ends 814 when the staples are positioned within the staple cavities 812 . As the staples are lifted upwardly out of the staple cavities 812, the legs 804 can elastically expand outwardly as they emerge from the staple cavities 812. For example, the staples may be positioned within the staple cavities 812 such that the tips 806 of the staple legs 804 do not extend above the top surface or platform of the cartridge body 810 when the staples are in their unfired or unraised positions. In such a position, the tip 806 may be positioned flush with or recessed below the platform 811 of the cartridge body 810 . Alternatively, the tip 806 of the leg 804 may extend at least partially above the platform 811 of the cartridge body 810 . In any event, as the staples are lifted upward, the staple tips 806 may emerge above the platform 811 and flare outward as the legs 804 emerge from the cavity 812 . At some point during the lifting of the staples, the legs 804 may no longer be in contact with the ends 814 of the staple cavities 812 and the legs 804 may no longer be biased inwardly by the sidewalls of the staple cavities 812 .
在各种情况下，砧座可包括一个或多个凹坑，该凹坑被构造成能够在钉800从钉仓射出时接收钉腿804的尖端806。砧座凹坑可被构造成能够例如将钉腿804向内朝彼此翻转或弯曲。在其他情况下，砧座凹坑可被构造成能够例如将钉腿804向外远离彼此翻转或弯曲。然而，在一些情况下，钉的钉腿中的一个或多个可错过钉凹坑并且可能无法适当地变形。在某些情况下，钉腿中的一个或多个可能不接触砧座并且可能根本不变形。在任一种情况下，钉可能不会将组织适当地捕获和/或保持在其组织截留区域内。此外，畸形或未成形的钉可能不能够向组织施加所需的压缩压力。在一些情况下，畸形或未成形的钉可能不保持在组织中并且可变得与组织脱离。In various circumstances, the anvil can include one or more dimples configured to receive the tips 806 of the staple legs 804 as the staples 800 are ejected from the staple cartridge. The anvil pockets can be configured to be able to flip or bend the staple legs 804 inwardly toward each other, for example. In other cases, the anvil pockets can be configured to flip or bend the staple legs 804 outwardly away from each other, for example. However, in some instances, one or more of the staple legs may miss the staple pocket and may not deform properly. In some cases, one or more of the staple legs may not contact the anvil and may not deform at all. In either case, the staples may not properly capture and/or retain tissue within their tissue-entrapping regions. Furthermore, misshapen or underformed staples may not be able to apply the desired compressive pressure to the tissue. In some instances, misshapen or underformed staples may not remain in the tissue and may become detached from the tissue.
再次参见图62，钉800和/或本文所公开的各种其他钉可包括从所述钉延伸的一个或多个倒钩。在各种情况下，倒钩可被构造成能够接合捕获在钉内和/或围绕钉的组织。在某些情况下，倒钩可有助于将钉保持在组织内，特别是当钉已成畸形或未成形时。钉800可包括从腿804中的一个或两个延伸的倒钩。例如，每个腿804可包括从钉800的中心面向外的一个或多个倒钩808以及/或者朝例如钉800的中心面向内的一个或多个倒钩809。在某些情况下，倒钩808可延伸远离组织截留区域807并且/或者倒钩809可朝组织截留区域807延伸或延伸到组织截留区域中。如图62所示，钉800的钉腿804中的两个可包括倒钩808和倒钩809。在一些情况下，钉腿804可包括倒钩808，但不包括倒钩809。钉820示于图63中，其包括倒钩808，但不包括倒钩809。在一些情况下，钉腿804可包括倒钩809，但不包括倒钩808。钉830,840,850,860和870分别示于图64、图65、图66、图67和图68中，其包括倒钩809，但不包括倒钩808。在一些实施方案中，例如，钉的第一腿804可包括倒钩808，而钉的第二腿804可包括倒钩809。Referring again to FIG. 62, staple 800 and/or various other staples disclosed herein can include one or more barbs extending from the staple. In various instances, the barbs can be configured to engage tissue captured within and/or surrounding the staple. In some cases, the barbs can help retain the staples within the tissue, particularly when the staples have become misshapen or underformed. Staple 800 may include barbs extending from one or both of legs 804 . For example, each leg 804 may include one or more barbs 808 facing outward from the center of the staple 800 and/or one or more barbs 809 facing inward, eg, toward the center of the staple 800 . In some cases, barbs 808 can extend away from tissue entrapment region 807 and/or barbs 809 can extend toward or into tissue entrapment region 807 . As shown in FIG. 62 , two of legs 804 of staple 800 may include barbs 808 and barbs 809 . In some cases, staple legs 804 may include barbs 808 but not barbs 809 . Nail 820 is shown in FIG. 63 and includes barb 808 but does not include barb 809 . In some cases, staple legs 804 may include barbs 809 but not barbs 808 . Nails 830 , 840 , 850 , 860 and 870 are shown in FIGS. 64 , 65 , 66 , 67 and 68 , respectively, and include barb 809 but not barb 808 . In some embodiments, for example, the first leg 804 of the staple can include barbs 808 and the second leg 804 of the staple can include barbs 809 .
在各种情况下，当钉处于未成形构型中时，钉的腿804和基部802可限定钉平面。倒钩808可从此类钉平面内的腿804向外延伸。类似地，倒钩809可从此类平面内的腿804向内延伸。在一些情况下，钉可包括相对于此类钉平面横向延伸的倒钩。可以设想到其他实施方案，其中腿804和基部802不位于或完全位于单个平面内。在此类实施方案中，倒钩可沿任何合适的方向延伸。在各种实施方案中，现在参见图67，钉诸如钉860例如可包括从基部802延伸的倒钩803。在各种情况下，倒钩803可向内朝钉860的组织截留区域807延伸。在某些情况下，倒钩803可向外远离组织截留区域807延伸。如图67所示，倒钩803可在由腿804和基部802限定的钉平面内延伸。在某些情况下，倒钩803可相对于此类钉平面横向延伸。各种示例性倒钩构型在下文中进一步详细地讨论。In various circumstances, the legs 804 and base 802 of the staple can define a staple plane when the staple is in the unformed configuration. Barbs 808 may extend outwardly from legs 804 in the plane of such staples. Similarly, barbs 809 may extend inwardly from legs 804 in such a plane. In some cases, staples may include barbs that extend transversely relative to the plane of such staples. Other embodiments are contemplated in which the legs 804 and base 802 do not lie, or lie entirely, in a single plane. In such embodiments, the barbs may extend in any suitable direction. In various embodiments, referring now to FIG. 67 , a staple such as staple 860 , for example, can include a barb 803 extending from a base 802 . In various circumstances, barbs 803 can extend inwardly toward tissue-entrapping region 807 of staple 860 . In some cases, barbs 803 may extend outwardly away from tissue entrapment region 807 . As shown in FIG. 67 , barb 803 can extend within the nail plane defined by leg 804 and base 802 . In some cases, barbs 803 may extend transversely relative to the plane of such staples. Various exemplary barb configurations are discussed in further detail below.
在各种情况下，钉腿804可包括沿其整个长度延伸的倒钩808的阵列。在一些情况下，钉腿804可包括沿小于其整个长度延伸的倒钩808的阵列。以举例的方式，参见图62，钉800的腿804各自包括沿小于腿804的整个长度延伸的倒钩808的阵列。类似地，参见图63，钉820的腿804各自包括沿小于腿804的整个长度延伸的倒钩808的阵列。参照钉800，例如，倒钩808的阵列可沿腿804中的每个从钉800的基部802朝腿804的尖端806延伸。如图62所示，倒钩808的阵列可能不延伸到腿804的尖端806。在各种情况下，倒钩808的阵列可沿例如腿804的长度的一半或大约一半延伸；然而，可使用倒钩阵列的任何合适的长度。例如，倒钩808的阵列可沿小于腿804的长度一半或大于其长度的一半延伸。在一些实施方案中，倒钩808的阵列可沿腿804中的每个从腿804的尖端806朝基部802延伸。在此类实施方案中，倒钩808的阵列可能不延伸到基部802。在一些实施方案中，腿804可包括倒钩808的阵列，其不延伸到腿804的尖端806或基部802。在某些实施方案中，腿804可包括倒钩808的多于一个阵列。In various cases, staple leg 804 can include an array of barbs 808 extending along its entire length. In some cases, staple legs 804 can include an array of barbs 808 extending along less than their entire length. By way of example, referring to FIG. 62 , legs 804 of staple 800 each include an array of barbs 808 extending along less than the entire length of leg 804 . Similarly, referring to FIG. 63 , the legs 804 of the staples 820 each include an array of barbs 808 extending along less than the entire length of the legs 804 . Referring to the staple 800 , for example, an array of barbs 808 may extend along each of the legs 804 from the base 802 of the staple 800 toward the tip 806 of the leg 804 . As shown in FIG. 62 , the array of barbs 808 may not extend to the tip 806 of the leg 804 . In various cases, the array of barbs 808 can extend along, for example, half or about half the length of the leg 804; however, any suitable length for the array of barbs can be used. For example, the array of barbs 808 may extend along less than half the length of the leg 804 or more than half the length thereof. In some embodiments, the array of barbs 808 can extend along each of the legs 804 from the tip 806 of the leg 804 toward the base 802 . In such embodiments, the array of barbs 808 may not extend to the base 802 . In some embodiments, the leg 804 can include an array of barbs 808 that do not extend to the tip 806 or the base 802 of the leg 804 . In certain embodiments, legs 804 may include more than one array of barbs 808 .
在各种情况下，对上文进行进一步描述，钉腿804可包括沿其整个长度延伸的倒钩809的阵列。以举例的方式，参见图64，钉830的腿804各自包括沿腿804的整个长度延伸的倒钩809的阵列。在一些情况下，钉腿804可包括沿小于其整个长度延伸的倒钩809的阵列。以举例的方式，参见图65，钉840的腿804各自包括沿小于腿804的整个长度延伸的倒钩809的阵列。类似地，参见图68，钉870的腿804各自包括沿小于腿804的整个长度延伸的倒钩809的阵列。参照钉840，例如，倒钩809的阵列可沿腿804中的每个从钉840的基部802朝腿804的尖端806延伸。如图65所示，倒钩809的阵列可能不延伸到腿804的尖端806。在各种情况下，倒钩809的阵列可沿例如腿804的长度的一半或大约一半延伸；然而，可使用倒钩阵列的任何合适的长度。例如，倒钩809的阵列可沿小于腿804的长度一半或大于其长度的一半延伸。在一些实施方案中，倒钩809的阵列可沿腿804中的每个从腿804的尖端806朝基部802延伸。在此类实施方案中，倒钩809的阵列可能不延伸到基部802。在一些实施方案中，如图66所示，腿804可包括倒钩809的阵列，其不延伸到腿804的尖端806或基部802。在某些实施方案中，腿804可包括倒钩809的多于一个阵列。In various cases, further to the above, staple legs 804 can include an array of barbs 809 extending along their entire length. By way of example, referring to FIG. 64 , the legs 804 of the staples 830 each include an array of barbs 809 extending along the entire length of the legs 804 . In some cases, staple leg 804 can include an array of barbs 809 extending along less than its entire length. By way of example, referring to FIG. 65 , the legs 804 of the staples 840 each include an array of barbs 809 extending along less than the entire length of the legs 804 . Similarly, referring to FIG. 68 , the legs 804 of the staples 870 each include an array of barbs 809 extending along less than the entire length of the legs 804 . Referring to the staple 840 , for example, an array of barbs 809 may extend along each of the legs 804 from the base 802 of the staple 840 toward the tip 806 of the leg 804 . As shown in FIG. 65 , the array of barbs 809 may not extend to the tip 806 of the leg 804 . In various cases, the array of barbs 809 can extend along, for example, half or about half the length of the leg 804; however, any suitable length of the barb array can be used. For example, the array of barbs 809 may extend along less than half the length of the leg 804 or more than half the length thereof. In some embodiments, the array of barbs 809 can extend along each of the legs 804 from the tip 806 of the leg 804 toward the base 802 . In such embodiments, the array of barbs 809 may not extend to the base 802 . In some embodiments, as shown in FIG. 66 , the leg 804 can include an array of barbs 809 that do not extend to the tip 806 or the base 802 of the leg 804 . In certain embodiments, legs 804 may include more than one array of barbs 809 .
各种倒钩构型示于图70至图73中，但任何合适的倒钩构型均可使用。参见图70，钉腿804可包括例如至少一个倒钩809。在各种情况下，倒钩809可包括插脚。插脚可包括可从钉腿804的周边805延伸的第一表面809a和第二表面809b。第一表面809a可包括例如倾斜表面、凸形表面和/或凹形表面。第二表面809b可包括例如平坦的或至少基本上平坦的表面。在各种情况下，第一表面809a和第二表面809b可会聚在例如边缘809c处。倒钩809可使用任何合适的工艺形成。例如，倒钩809可使用冲压工艺形成。在至少一个实施方案中，成形模具例如可用于冲击包括腿804的线的周边805，以便扰乱或干扰足够的材料来形成倒钩809。在各种情况下，倒钩可包括例如任何合适的尖头或毛刺。在各种实施方案中，倒钩809可为锥形的。在各种情况下，倒钩809可包括与周边805相邻的基部，该基部比倒钩809的尖端厚。Various barb configurations are shown in Figures 70-73, but any suitable barb configuration may be used. Referring to FIG. 70 , staple legs 804 can include at least one barb 809 , for example. In various cases, barbs 809 may comprise prongs. The prong can include a first surface 809a and a second surface 809b that can extend from the perimeter 805 of the staple leg 804 . The first surface 809a may include, for example, an inclined surface, a convex surface, and/or a concave surface. The second surface 809b may comprise, for example, a planar or at least substantially planar surface. In various cases, the first surface 809a and the second surface 809b may converge at, for example, an edge 809c. Barbs 809 may be formed using any suitable process. For example, barbs 809 may be formed using a stamping process. In at least one embodiment, a forming die may be used, for example, to impact the perimeter 805 of the wire including the legs 804 in order to disturb or disrupt enough material to form the barbs 809 . In various instances, the barbs may comprise, for example, any suitable prongs or burrs. In various embodiments, the barbs 809 can be tapered. In various cases, the barb 809 can include a base adjacent the perimeter 805 that is thicker than the tip of the barb 809 .
现在参见图68、图69、图71和图71A，钉腿804可包括例如至少一个倒钩879。在至少一个实施方案中，倒钩879可围绕钉腿804的周边805的一部分延伸。在各种情况下，倒钩879可包括可从钉腿804的周边805延伸的第一表面879a和第二表面879b。第一表面879a可包括例如倾斜表面、凸形表面和/或凹形表面。第二表面879b可包括例如平坦的或至少基本上平坦的表面。在各种情况下，第一表面879a和第二表面879b可会聚在例如边缘879c处。在各种情况下，边缘879c可为例如弓形的。倒钩879可使用任何合适的工艺形成。例如，倒钩879可使用冲压工艺形成。在至少一个实施方案中，成形模具例如可用于冲击包括腿804的线的周边805，以便扰乱或干扰足够的材料来形成倒钩879。主要参见图71A，包括腿804的线可由直径801限定，并且倒钩879可由比直径801大的直径限定。相应地，包括腿804的线可由半径限定，并且倒钩879可由比线半径大的半径限定。在各种实施方案中，倒钩879可为锥形的。在各种情况下，倒钩879可包括与周边805相邻的基部，该基部比倒钩879的尖端厚。Referring now to FIGS. 68 , 69 , 71 and 71A , staple legs 804 can include at least one barb 879 , for example. In at least one embodiment, the barb 879 can extend around a portion of the perimeter 805 of the staple leg 804 . In various circumstances, the barb 879 can include a first surface 879a and a second surface 879b that can extend from the perimeter 805 of the staple leg 804 . The first surface 879a may include, for example, an inclined surface, a convex surface, and/or a concave surface. The second surface 879b may comprise, for example, a planar or at least substantially planar surface. In various cases, the first surface 879a and the second surface 879b can converge at, for example, an edge 879c. In various instances, edge 879c may be arcuate, for example. Barbs 879 may be formed using any suitable process. For example, barbs 879 may be formed using a stamping process. In at least one embodiment, a forming die may be used, for example, to impact the perimeter 805 of the wire including the legs 804 in order to disturb or disrupt enough material to form the barbs 879 . Referring primarily to FIG. 71A , the wire including legs 804 can be defined by a diameter 801 , and the barbs 879 can be defined by a larger diameter than diameter 801 . Accordingly, the wire including the legs 804 may be defined by a radius, and the barbs 879 may be defined by a radius that is greater than the wire radius. In various embodiments, the barbs 879 can be tapered. In various cases, the barb 879 can include a base adjacent the perimeter 805 that is thicker than the tip of the barb 879 .
现在参见图72，钉腿804可包括例如至少一个倒钩889。在至少一个实施方案中，倒钩889可围绕钉腿804的整个周边805延伸。在各种情况下，倒钩889可包括可从钉腿804的周边805延伸的第一表面889a和第二表面889b。第一表面889a可包括例如倾斜表面、凸形表面和/或凹形表面。第二表面889b可包括例如平坦的或至少基本上平坦的表面。在各种情况下，第一表面889a和第二表面889b可会聚在例如边缘889c处。在各种情况下，边缘889c可为例如弓形的。倒钩889可使用任何合适的工艺形成。例如，倒钩889可使用冲压工艺形成。在至少一个实施方案中，成形模具例如可用于冲击包括腿804的线的周边805，以便扰乱或干扰足够的材料来形成倒钩889。包括腿804的线可由线直径限定，并且倒钩889可由比线直径大的直径限定。相应地，包括腿804的线可由半径限定，并且倒钩889可由比线半径大的半径限定。在各种实施方案中，倒钩889可为锥形的。在各种情况下，倒钩889可包括与周边805相邻的基部，该基部比倒钩889的尖端厚。Referring now to FIG. 72 , staple legs 804 can include at least one barb 889 , for example. In at least one embodiment, the barbs 889 can extend around the entire perimeter 805 of the staple legs 804 . In various circumstances, the barb 889 can include a first surface 889a and a second surface 889b that can extend from the perimeter 805 of the staple leg 804 . The first surface 889a may include, for example, an inclined surface, a convex surface, and/or a concave surface. The second surface 889b may comprise, for example, a planar or at least substantially planar surface. In various cases, the first surface 889a and the second surface 889b can converge at, for example, an edge 889c. In various cases, edge 889c may be arcuate, for example. Barbs 889 may be formed using any suitable process. For example, barbs 889 may be formed using a stamping process. In at least one embodiment, a forming die may be used, for example, to impact the perimeter 805 of the wire including the legs 804 in order to disturb or disrupt enough material to form the barbs 889 . The wire including the legs 804 may be defined by a wire diameter, and the barbs 889 may be defined by a diameter larger than the wire diameter. Accordingly, the wire including the legs 804 may be defined by a radius, and the barbs 889 may be defined by a radius that is greater than the wire radius. In various embodiments, the barbs 889 can be tapered. In various cases, the barb 889 can include a base adjacent the perimeter 805 that is thicker than the tip of the barb 889 .
现在参见图73，钉腿804可包括例如至少一个倒钩899。在各种情况下，倒钩899可包括插脚。插脚可包括可从钉腿804的周边延伸的第一表面899a和第二表面899b。第一表面899a可包括例如倾斜表面、凸形表面和/或凹形表面。第二表面899b可包括例如平坦的或至少基本上平坦的表面。在各种情况下，第一表面899a和第二表面899b可会聚在例如边缘899c处。倒钩899可使用任何合适的工艺形成。例如，倒钩899可使用冲压工艺形成。在至少一个实施方案中，成形模具例如可用于冲击包括腿804的线的周边，以便扰乱或干扰足够的材料来形成倒钩899。在各种实施方案中，包括钉的线可包括一个或多个平坦侧面。在至少一个实施方案中，线可包括例如相对的平坦侧面895。在至少一个此类实施方案中，平坦侧面895可形成为圆柱形线。在一些情况下，除了平坦侧面895之外，线可保持一个或多个圆柱形表面。在各种情况下，倒钩可包括例如任何合适的尖头或毛刺。在各种实施方案中，倒钩899可为锥形的。在各种情况下，倒钩899可包括与腿804的周边相邻的基部，该基部比倒钩899的尖端厚。Referring now to FIG. 73 , staple legs 804 can include at least one barb 899 , for example. In various cases, barbs 899 can include prongs. The prong can include a first surface 899a and a second surface 899b that can extend from the perimeter of the staple leg 804 . The first surface 899a may include, for example, a sloped surface, a convex surface, and/or a concave surface. The second surface 899b may comprise, for example, a planar or at least substantially planar surface. In various cases, the first surface 899a and the second surface 899b can converge at, for example, an edge 899c. Barbs 899 may be formed using any suitable process. For example, barbs 899 may be formed using a stamping process. In at least one embodiment, a forming die may be used, for example, to impact the perimeter of the wire including legs 804 in order to disrupt or disturb enough material to form barbs 899 . In various embodiments, a wire including a staple may include one or more flat sides. In at least one embodiment, the wire can include opposing flat sides 895, for example. In at least one such embodiment, the flat sides 895 can be formed as cylindrical wires. In some cases, the wire may retain one or more cylindrical surfaces other than flat sides 895 . In various instances, the barbs may comprise, for example, any suitable prongs or burrs. In various embodiments, the barbs 899 can be tapered. In various cases, the barb 899 can include a base adjacent the perimeter of the leg 804 that is thicker than the tip of the barb 899 .
在各种情况下，钉的腿可限定钉平面。钉的基部可以或可以不定位在钉平面内。在任一种情况下，从腿和/或基部延伸的一个或多个倒钩可在钉平面内延伸以及/或者相对于钉平面平行地延伸。在一些情况下，从腿和/或基部延伸的一个或多个倒钩可从钉平面向外延伸。从腿和/或基部延伸的一个或多个倒钩可相对于钉平面横向地延伸。在各种情况下，倒钩可围绕钉腿周向地延伸。此类倒钩可在钉平面内延伸以及从钉平面向外延伸。在一些情况下，倒钩可围绕钉腿的整个周长延伸。在某些情况下，倒钩可围绕钉腿延伸小于360度。在钉平面内延伸的倒钩可易于控制钉平面内的组织。从钉平面向外延伸的倒钩可易于控制钉平面之外的组织。钉和/或钉腿可包括在钉平面内延伸的一个或多个倒钩以及从钉平面向外延伸的一个或多个倒钩。In various cases, the legs of the staple can define a staple plane. The base of the staple may or may not be positioned in the plane of the staple. In either case, the one or more barbs extending from the legs and/or base can extend in the plane of the nail and/or parallel to the plane of the nail. In some cases, one or more barbs extending from the legs and/or base can extend outward from the plane of the nail. One or more barbs extending from the legs and/or base can extend transversely relative to the plane of the staple. In various instances, the barbs can extend circumferentially about the staple legs. Such barbs may extend in the plane of the nail as well as extend outward from the plane of the nail. In some cases, the barbs can extend around the entire perimeter of the staple legs. In some cases, the barb may extend less than 360 degrees around the staple leg. Barbs extending in the plane of the staple can facilitate tissue control in the plane of the staple. Barbs extending outward from the plane of the staple can facilitate manipulation of tissue outside the plane of the staple. The staples and/or staple legs may include one or more barbs extending in the plane of the staple and one or more barbs extending outward from the plane of the staple.
再次参见图62，从钉腿804延伸的倒钩可被构造成能够将钉腿804保持在组织内。如上所述，在某些情况下，钉腿804可通过砧座成畸形和/或未成形，并且由于从该钉腿延伸的一个或多个倒钩，钉腿804可仍然保持在组织内。在各种情况下，倒钩可被构造成能够将组织截留在钉的组织截留区域内。在某些情况下，倒钩可被构造成能够抵靠基部802保持组织。在此类情况下，倒钩可向组织施加压缩力或压力。如上结合图70至图73所示的实施方案所述，倒钩可包括例如倾斜、凸形和/或凹形顶部表面，诸如表面809a,879a,889a和/或899a。倒钩的顶部表面可被构造成能够有利于将钉腿804和倒钩插入组织中和/或插入穿过组织。同样如上结合图70至图73所示的实施方案所述，倒钩可包括例如平坦或至少基本上平坦的底部表面，诸如表面809b,879b,889b和/或899b。倒钩的底部表面可被构造成能够抑制将倒钩和钉腿804从组织移除。作为上述的结果，在某些情况下，倒钩的顶部表面可被构造成能够刺穿组织，而倒钩的底部表面可被构造成能够邻接组织。在各种情况下，钉腿804的尖端806可被构造成能够在组织中穿刺孔，而钉腿804和从该钉腿延伸的倒钩可被构造成能够弹性地展开孔，使得组织可在钉腿804被推动穿过组织时在倒钩周围流动并且流回到倒钩的底部表面下方。Referring again to FIG. 62, the barbs extending from the staple legs 804 can be configured to retain the staple legs 804 within tissue. As noted above, in some instances, the staple legs 804 can be misshapen and/or unshaped by the anvil, and the staple legs 804 can remain within the tissue due to one or more barbs extending from the staple legs. In various circumstances, the barbs can be configured to trap tissue within the tissue-entrapping region of the staple. In some cases, the barbs may be configured to retain tissue against base 802 . In such cases, the barbs can apply compressive force or pressure to the tissue. As described above in connection with the embodiments shown in FIGS. 70-73 , the barbs may include, for example, sloped, convex, and/or concave top surfaces, such as surfaces 809a, 879a, 889a, and/or 899a. The top surface of the barb can be configured to facilitate insertion of the staple legs 804 and the barb into and/or through tissue. Also as described above in connection with the embodiments shown in FIGS. 70-73 , the barbs may include, for example, a flat or at least substantially flat bottom surface, such as surfaces 809b, 879b, 889b and/or 899b. The bottom surface of the barbs can be configured to inhibit removal of the barbs and staple legs 804 from tissue. As a result of the above, in some cases, the top surface of the barb can be configured to pierce tissue, while the bottom surface of the barb can be configured to abut tissue. In various cases, the tip 806 of the staple leg 804 can be configured to penetrate a hole in the tissue, and the staple leg 804 and the barbs extending from the staple leg can be configured to elastically expand the hole so that the tissue can be opened in the tissue. Staple legs 804 flow around the barbs and back below the bottom surface of the barbs as they are pushed through tissue.
在某些实施方案中，第一倒钩可从钉的第一腿804延伸，并且第二倒钩可从钉的第二腿804延伸。在各种情况下，第一倒钩和第二倒钩可位于基部802之间相同或至少基本上相同的距离。在某些情况下，第一倒钩和第二倒钩可距基部802相同或至少基本上相同的竖直距离定位。如上所述，钉腿804可包括沿钉腿804的长度延伸的倒钩的阵列。在各种实施方案中，主要参见图62，钉可包括具有倒钩的第一阵列的第一腿804以及具有倒钩的第二阵列的第二腿804，其中倒钩的第一阵列和倒钩的第二阵列可被构造成能够协作地将钉保持在组织内。在各种实施方案中，来自第一阵列的倒钩和来自第二阵列的倒钩可包括被构造成能够在距例如基部802相同竖直距离处接合组织的一对倒钩。在各种情况下，钉可包括多于一对倒钩。在某些情况下，倒钩对中的每对可被够造成在距基部802不同竖直距离处接合组织。在此类情况下，钉可适合以不同组织厚度使用。例如，当钉用于缝合薄的组织时，一对倒钩或小于所有的倒钩对可接合薄的组织。如果钉用于缝合厚的组织，然而，附加的倒钩对或所有的倒钩对可接合组织。在某些实施方案中，从腿804延伸的倒钩可以按照组织厚度或组织厚度的范围的方式布置，所述组织厚度由钉缝合。例如，再次参见图62，倒钩808和809可沿腿804选择性地定位，使得其定位在捕获在钉内的组织内和/或与捕获在钉内的组织相邻定位。在某些情况下，钉腿804的通过砧座变形或与砧座接触的部分可不包括从其延伸的倒钩。在至少一些情况下，从钉腿804的面向内的侧面延伸的倒钩的阵列可长于从钉腿804的面向外的侧面延伸的倒钩的阵列。在其他情况下，从钉腿804的面向内的侧面延伸的倒钩的阵列可短于从钉腿804的面向外的侧面延伸的倒钩的阵列。在又一种情况下，从钉腿804的面向内的侧面延伸的倒钩的阵列可与从钉腿804的面向外的侧面延伸的倒钩的阵列一样长。In certain embodiments, a first barb can extend from the first leg 804 of the staple and a second barb can extend from the second leg 804 of the staple. In various cases, the first barb and the second barb can be located the same, or at least substantially the same, distance between the bases 802 . In some cases, the first barb and the second barb may be positioned the same, or at least substantially the same, vertical distance from the base 802 . As noted above, the staple legs 804 may include an array of barbs extending along the length of the staple legs 804 . In various embodiments, referring primarily to FIG. 62 , a staple can include a first leg 804 having a first array of barbs and a second leg 804 having a second array of barbs, wherein the first array of barbs and the barbs The second array of hooks can be configured to cooperatively retain the staples within tissue. In various embodiments, the barbs from the first array and the barbs from the second array can comprise a pair of barbs configured to engage tissue at the same vertical distance from, eg, base 802 . In various cases, a nail may include more than one pair of barbs. In some cases, each of the barb pairs may be caused to engage tissue at different vertical distances from the base 802 . In such cases, the staples may be adapted for use with different tissue thicknesses. For example, when the staple is used to suture thin tissue, one pair of barbs, or less than all of the barb pairs, may engage thin tissue. If the staples are used to staple thick tissue, however, additional barb pairs or all barb pairs may engage the tissue. In certain embodiments, the barbs extending from the legs 804 can be arranged in a manner of a thickness of tissue or a range of thicknesses of tissue that are stapled together. For example, referring again to FIG. 62, barbs 808 and 809 can be selectively positioned along leg 804 such that they are positioned within and/or adjacent to tissue captured within the staple. In some cases, the portion of staple leg 804 deformed by or in contact with the anvil may not include barbs extending therefrom. In at least some cases, the array of barbs extending from the inward-facing side of staple leg 804 can be longer than the array of barbs extending from the outward-facing side of staple leg 804 . In other cases, the array of barbs extending from the inward-facing side of staple leg 804 may be shorter than the array of barbs extending from the outward-facing side of staple leg 804 . In yet another case, the array of barbs extending from the inward-facing side of staple leg 804 may be as long as the array of barbs extending from the outward-facing side of staple leg 804 .
如上所述，如果钉腿804是畸形的以及/或者无意未成形的，则从钉腿804延伸的倒钩可有助于将钉保持在组织内。然而，可设想到某些情况，其中包括本文所公开的倒钩中的一个或多个的钉被插入组织中并且保持有意未成形的。在任何情况下，包括本文所公开的倒钩中的一个或多个的钉可用于缝合厚的组织。更具体地讲，在一些情况下，在钉仓和砧座之间的厚和/或致密组织的存在以及/或者在钉内的厚和/或致密组织的存在可防止钉完全成形或闭合。例如，钉可能不完全闭合成B形式构型，或者钉可能不完全闭合。在此类情况下，未闭合的钉的倒钩可能抑制或防止组织被拉出例如钉。沿钉腿的长度的延伸的倒钩的阵列可允许腿保持在组织中，而不管组织的厚度。As noted above, the barbs extending from the staple legs 804 can help retain the staples within tissue if the staple legs 804 are misshapen and/or unintentionally underformed. However, certain situations are envisioned where a staple comprising one or more of the barbs disclosed herein is inserted into tissue and remains intentionally unformed. In any event, a staple comprising one or more of the barbs disclosed herein can be used to suture thick tissue. More specifically, in some cases, the presence of thick and/or dense tissue between the staple cartridge and the anvil and/or within the staples can prevent the staples from fully forming or closing. For example, the staples may not fully close into the B-form configuration, or the staples may not fully close. In such cases, the barbs of the unclosed staples may inhibit or prevent tissue from being pulled out, such as the staples. The array of barbs extending along the length of the staple legs can allow the legs to remain in tissue regardless of tissue thickness.
可设想到各种实施方案，其中至少一个带倒钩的钉诸如带倒钩的钉800例如可移除地储存在钉仓诸如图10至图12所示的钉仓22000内。可设想到其中钉仓仅包括带倒钩的钉的某些实施方案，同时设想到使用带倒钩的钉和不带倒钩的钉的其他实施方案。例如，第一行钉可包括带倒钩的钉，而第二行钉可包括不带倒钩的钉。在一些情况下，储存在钉仓内的钉可具有相同或基本上相同的未成形高度。至少参照U形形状和/或V形形状的钉，例如，钉的未成形高度可被限定为钉的基部的底部和钉腿的尖端之间的竖直距离。在钉被插入钉仓中之前，在钉可移除地储存在钉仓内时，以及/或者在钉抵靠砧座变形之前，可采取此类测量。在一些情况下，在钉仓中布置在第一排中的带倒钩的钉可具有第一未成形高度，并且在钉仓中布置在第二排中的带倒钩的钉可具有第二未成形高度。在钉仓中的第三排中的带倒钩的钉可具有第一未成形高度、第二未成形高度或第三未成形高度。第一行、第二行和/或第三行的带倒钩的钉可被定位在限定于钉仓中的刀狭槽的相同侧上或刀狭槽的相对侧上。在使用中，可移除地储存在钉仓中的带倒钩的钉可被成形为相同成形高度或不同成形高度。钉的成形高度可被定义为在其已抵靠砧座变形之后钉的总竖直距离。至少参照已变形成B形式的钉，例如，可在钉的基部的底部和钉腿的最上部分之间测量钉的成形高度。在一些情况下，在钉仓中布置在第一排中的带倒钩的钉可变形成第一成形高度，并且在钉仓中布置在第二排中的带倒钩的钉可变形成第二成形高度。在钉仓中的第三排中的带倒钩的钉可具有第一成形高度、第二成形高度或第三成形高度。第一排、第二排和/或第三排的带倒钩的钉可被定位在限定于钉仓中的刀狭槽的相同侧上或钉仓的相对侧上。如读者将理解的，示于图10至图12中的钉已变形成不同成形高度。带倒钩的钉800例如可用于形成具有不同成形高度的钉排的钉仓和/或缝合器械中。第一排的带倒钩的钉800可变形为第一成形高度，并且第二排的带倒钩的钉800可变形为第二成形高度。在各种情况下，第三排的带倒钩的钉800可变形为第三成形高度。在一些情况下，变形为不同高度的带倒钩的钉800可开始于相同或基本上相同的未成形高度。在某些情况下，变形为不同成形高度的带倒钩的钉800可开始于不同未成形高度。各种结构可用于使钉成形为不同成形高度。例如，支撑钉的可动驱动器可在相对于砧座的不同距离处支撑钉。在一些情况下，砧座可包括具有不同深度的钉成形凹坑。在各种情况下，钉驱动器可包括支架，该支架被构造成能够支撑钉的基部并且向上朝限定于砧座中的成形凹坑推动钉。钉的成形高度可通过支架的底部表面和成形凹坑的顶部表面之间的距离来确定。公布于2012年11月27日的名称为“SURGICAL STAPLINGDEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS”的美国专利8,317,070以引用方式全文并入。在某些情况下，钉仓的平台可包括阶梯式表面，如图1所示。第一排的钉腔可限定于第一阶梯中，并且第二排的钉腔可限定于第二阶梯中，其中第一阶梯和第二阶梯可彼此竖直地偏移。例如，第一阶梯可竖直地定位在砧座上方，或者比第二阶梯更靠近砧座定位。在某些情况下，壁可定位在第一阶梯和第二阶梯之间。在一些情况下，钉仓的平台可包括第一阶梯、竖直地定位在第一阶梯上方的第二阶梯，以及竖直地定位在第二阶梯上方的第三阶梯。可设想到各种实施方案，其中钉仓的平台包括任何合适数目的阶梯以及在阶梯之间的任何合适数目的壁。例如，第一排的钉腔可限定于第一阶梯中，第二排的钉腔可限定于第二阶梯中，并且/或者第三排的钉腔可限定于第三阶梯中。例如，第一行的钉腔可包括具有第一未成形高度的钉，第二排的钉腔可包括具有第二未成形高度的钉，并且/或者第三排的钉腔可包括具有第三未成形高度的钉。可设想到各种实施方案，其中钉仓包括具有不同未成形高度的任何合适数目的钉排。例如，第一排钉腔中的钉可变形为第一成形高度，第二排钉腔中的钉可变形为第二成形高度，并且/或者第三排钉腔可变形为第三成形高度。可设想到各种实施方案，其中钉仓包括变形为不同成形高度的任何合适数目的钉排。除了具有不同成形钉高度之外或代替具有不同钉高度，缝合器械的端部执行器可具有不同组织间隙。例如，通常参见图10和图11，间隙可被限定在钉仓的仓平台表面22011和砧座的砧座组织压缩表面10063之间。该间隙可被构造成能够接收组织T。该间隙也可被构造成能够接收组织厚度补偿件；然而，带倒钩的钉可以或者可以不与组织厚度补偿件一起使用，并且相对于带倒钩的钉提供的讨论可适用于任一种情况。在任何情况下，读者将理解，砧座组织压缩表面10063是阶梯式的。砧座组织压缩表面10063包括竖直地定位在第二部分上方的第一部分。当端部执行器的砧座和钉仓处于闭合状态时，如图11所示，第一间隙距离限定在砧座组织压缩表面10063的外部部分和仓平台表面22011之间，并且第二不同的间隙距离限定在砧座组织压缩表面10063的内部部分和仓平台表面22011之间。第一间隙距离被示为大于第二间隙距离，但是第一间隙距离有可能短于第二间隙距离。以较短间隙距离压缩在砧座和钉仓之间的组织可比以较大间隙距离的组织更受压缩。例如，带倒钩的钉800的倒钩可不同地接合组织，这取决于组织定位在较短组织间隙还是较大组织间隙内。更具体地，压缩在较短组织间隙内的组织可在其从端部执行器释放之后寻求比压缩在较大组织间隙内的组织更加重新展开，并且带倒钩的钉的倒钩可抑制或抵抗该重新展开，这取决于其构型和/或在倒钩上的位置。在其他情况下，倒钩可被构造成能够和/或定位成不抑制或抵抗组织的重新展开。如读者将理解的，砧座组织压缩表面10063是阶梯式的，并且仓平台表面是平坦或至少基本上平坦的，并且因此，限定在端部执行器内的组织间隙的差值随阶梯式砧座表面的高度而变化。可设想到其他实施方案。例如，砧座组织压缩表面可为平坦或至少基本上平坦的，并且仓平台表面可为阶梯式的。在其他情况下，砧座组织压缩表面和仓平台表面可均为阶梯式的。在任何情况下，不同间隙距离可限定在砧座组织压缩表面和仓平台表面之间。虽然两个间隙距离已在图10和图11中示出，但是可能多于两个间隙距离，诸如三个间隙距离。参照图10和图11，第一纵向排的成形凹坑可布置在端部执行器的具有第一组织间隙距离的第一部分内，并且第二纵向排的成形凹坑可布置在端部执行器的具有不同于第一组织间隙距离的第二组织间隙距离的第二部分内。在一些情况下，端部执行器可包括第三纵向排的成形凹坑，其布置在端部执行器的具有不同于第一组织间隙距离和第二组织间隙距离的第三组织间隙距离的第三部分内。在某些情况下，端部执行器可包括第三纵向排的成形凹坑，其布置在端部执行器的具有与第一组织间隙距离或第二组织间隙距离相同的组织间隙距离的第三部分内。读者将理解，端部执行器可具有不同组织间隙距离和/或不同成形钉高度。端部执行器可以具有一者、另一者，或两者兼有。在某些情况下，较短成形钉高度可与较短组织间隙距离相关联，而较大成形钉高度可与较大组织间隙距离相关联。在其他情况下，较短成形钉高度可与较大组织间隙距离相关联，而较大成形钉高度可与较短组织间隙距离相关联。对上文进行进一步描述，钉在其未成形状态中可具有U形形状构型。U形形状的钉可包括基部和从基部延伸的两个钉腿，其中钉腿沿平行的方向延伸到彼此。另外对上文进行进一步描述，钉在其未成形状态中可包括V形形状构型。V形形状构型可包括基部和从基部延伸的两个钉腿，其中钉腿沿不平行的方向延伸。Various embodiments are contemplated wherein at least one barbed staple such as barbed staple 800 is removably stored within a staple cartridge such as staple cartridge 22000 shown in FIGS. 10-12 , for example. Certain embodiments are contemplated where the staple cartridge includes only barbed staples, while other embodiments using barbed and non-barbed staples are contemplated. For example, a first row of staples may include barbed staples, while a second row of staples may include non-barbed staples. In some cases, the staples stored within the staple cartridge can have the same or substantially the same unformed height. With reference at least to U-shaped and/or V-shaped staples, for example, the unformed height of the staple may be defined as the vertical distance between the bottom of the base of the staple and the tips of the staple legs. Such measurements may be taken before the staples are inserted into the staple cartridge, while the staples are removably stored within the staple cartridge, and/or before the staples are deformed against the anvil. In some cases, the barbed staples arranged in a first row in the staple cartridge can have a first unformed height, and the barbed staples arranged in a second row in the staple cartridge can have a second height. unformed height. The barbed staples in the third row in the staple cartridge can have a first unformed height, a second unformed height, or a third unformed height. The barbed staples of the first, second, and/or third rows may be positioned on the same side of the knife slot defined in the staple cartridge or on opposite sides of the knife slot. In use, the barbed staples removably stored in the staple cartridge may be formed to the same formed height or to different formed heights. The formed height of a staple can be defined as the total vertical distance of the staple after it has been deformed against the anvil. Referring at least to a staple that has been deformed into a B-form, for example, the formed height of the staple may be measured between the bottom of the base of the staple and the uppermost portion of the staple leg. In some cases, barbed staples arranged in a first row in the staple cartridge can be formed into a first formed height, and barbed staples arranged in a second row in the staple cartridge can be formed into a second height. 2. Forming height. The barbed staples in the third row in the staple cartridge can have a first formed height, a second formed height, or a third formed height. The barbed staples of the first, second, and/or third rows may be positioned on the same side of the knife slot defined in the staple cartridge or on opposite sides of the staple cartridge. As the reader will understand, the staples shown in Figures 10-12 have been deformed to different formed heights. Barbed staples 800 may be used, for example, in staple cartridges and/or stapling instruments that form rows of staples having different formed heights. A first row of barbed staples 800 can be deformed to a first formed height, and a second row of barbed staples 800 can be deformed to a second formed height. In various circumstances, the third row of barbed staples 800 can be deformed to a third formed height. In some cases, barbed staples 800 deformed to different heights may start at the same or substantially the same unformed height. In some cases, barbed staples 800 deformed to different formed heights may start at different unformed heights. Various configurations are available to form the staples to different formed heights. For example, a movable driver supporting a staple may support the staple at different distances relative to the anvil. In some cases, the anvil can include staple forming pockets of varying depths. In various cases, the staple driver can include a cradle configured to support the base of the staple and push the staple upwardly toward the forming pocket defined in the anvil. The formed height of the nail can be determined by the distance between the bottom surface of the bracket and the top surface of the formed pocket. US Patent 8,317,070, published on November 27, 2012, entitled "SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS," is incorporated by reference in its entirety. In some cases, the deck of the staple cartridge may include a stepped surface, as shown in FIG. 1 . A first row of staple cavities may be defined in a first step and a second row of staple cavities may be defined in a second step, wherein the first and second steps may be vertically offset from each other. For example, the first step may be positioned vertically above the anvil, or closer to the anvil than the second step. In some cases, a wall may be positioned between the first step and the second step. In some cases, the deck of the staple cartridge can include a first step, a second step positioned vertically above the first step, and a third step positioned vertically above the second step. Various embodiments are contemplated in which the deck of the staple cartridge includes any suitable number of steps and any suitable number of walls between the steps. For example, a first row of staple cavities may be defined in a first step, a second row of staple cavities may be defined in a second step, and/or a third row of staple cavities may be defined in a third step. For example, a first row of staple cavities can include staples with a first unformed height, a second row of staple cavities can include staples with a second unformed height, and/or a third row of staple cavities can include staples with a third unformed height. Nails of unformed height. Various embodiments are contemplated wherein the staple cartridge includes any suitable number of rows of staples having different unformed heights. For example, staples in a first row of staple cavities can be deformed to a first formed height, staples in a second row of staple cavities can be deformed to a second formed height, and/or staple cavities in a third row can be deformed to a third formed height. Various embodiments are contemplated in which the staple cartridge includes any suitable number of rows of staples deformed to different formed heights. In addition to or instead of having different formed staple heights, the end effectors of the stapling instrument may have different tissue clearances. For example, referring generally to FIGS. 10 and 11 , a gap can be defined between the cartridge deck surface 22011 of the staple cartridge and the anvil tissue compressing surface 10063 of the anvil. The gap can be configured to receive tissue T. FIG. The gap can also be configured to receive a tissue thickness compensator; however, barbed staples may or may not be used with tissue thickness compensators, and the discussion provided with respect to barbed staples is applicable to either Condition. In any event, the reader will understand that the anvil tissue compression surface 10063 is stepped. The anvil tissue compressing surface 10063 includes a first portion positioned vertically above a second portion. When the anvil of the end effector and the staple cartridge are in the closed state, as shown in FIG. A gap distance is defined between an interior portion of the anvil tissue compressing surface 10063 and the cartridge deck surface 22011. The first gap distance is shown as being greater than the second gap distance, but it is possible that the first gap distance is shorter than the second gap distance. Tissue compressed between the anvil and staple cartridge at a shorter gap distance may be more compressed than tissue at a larger gap distance. For example, the barbs of barbed staple 800 may engage tissue differently depending on whether the tissue is positioned within a shorter or larger tissue gap. More specifically, tissue compressed within a shorter tissue space may seek to re-expand more than tissue compressed within a larger tissue space after it is released from the end effector, and the barbs of the barbed staples may inhibit or Resists this re-deployment, depending on its configuration and/or position on the barb. In other cases, the barbs can be configured and/or positioned so as not to inhibit or resist tissue re-deployment. As the reader will appreciate, the anvil tissue compression surface 10063 is stepped and the cartridge deck surface is flat or at least substantially flat, and therefore, the difference in the tissue gap defined within the end effector varies with the stepped anvil The height of the seating surface varies. Other implementations are contemplated. For example, the anvil tissue compression surface can be flat or at least substantially flat, and the cartridge deck surface can be stepped. In other cases, both the anvil tissue compression surface and the cartridge deck surface may be stepped. In any event, different gap distances may be defined between the anvil tissue compression surface and the cartridge deck surface. Although two gap distances have been shown in FIGS. 10 and 11 , there may be more than two gap distances, such as three gap distances. Referring to FIGS. 10 and 11 , a first longitudinal row of shaped dimples may be disposed within a first portion of the end effector having a first tissue clearance distance, and a second longitudinal row of shaped dimples may be disposed within the end effector. within a second portion of the second tissue interstitial distance having a second interstitial distance different from the first interstitial distance. In some cases, the end effector may include a third longitudinal row of shaped dimples disposed at a third tissue gap distance of the end effector having a third tissue gap distance that is different from the first tissue gap distance and the second tissue gap distance. in three parts. In some cases, the end effector may include a third longitudinal row of shaped dimples disposed at a third tissue gap distance of the end effector having the same tissue gap distance as the first tissue gap distance or the second tissue gap distance. within the section. The reader will appreciate that end effectors may have different tissue gap distances and/or different formed staple heights. The end effector can have one, the other, or both. In some cases, shorter formed staple heights can be associated with shorter tissue interstitial distances, while larger formed staple heights can be associated with greater tissue interstitial distances. In other cases, shorter formed staple heights may be associated with greater tissue interstitial distances, while larger formed staple heights may be associated with shorter tissue interstitial distances. Further to the above, the staple may have a U-shaped configuration in its unformed state. A U-shaped staple may comprise a base and two staple legs extending from the base, wherein the staple legs extend to each other in parallel directions. Still further to the above, the staple in its unformed state may comprise a V-shaped configuration. The V-shaped configuration may include a base and two legs extending from the base, wherein the legs extend in non-parallel directions.
本文所述的各种实施方案在线性端部执行器和/或线性紧固件仓的上下文中描述。此类实施方案及其教导内容可应用于非线性端部执行器和/或非线性紧固件仓，诸如圆形和/或波状外形端部执行器。例如，包括非线性端部执行器的各种端部执行器在2011年2月28日提交的名称为“SURGICAL STAPLING INSTRUMENT”的美国专利申请序列号13/036,647(现为美国专利申请公布2011/0226837)中有所公开，该专利据此以引用方式全文并入。另外，2012年9月29日提交的名称为“STAPLE CARTRIDGE”的美国专利申请序列号12/893,461(现为美国专利申请公布2012/0074198)据此以引用方式全文并入。2008年2月15日提交的名称为“END EFFECTORS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT”的美国专利申请序列号12/031,873(现为美国专利7,980,443)也据此以引用方式全文并入。2010年12月7日公布的名称为“SURGICAL INSTRUMENT HAVINGRECORDING CAPABILITIES”的美国专利7,845,537的全部公开内容以引用方式并入本文。2011年5月27日提交的名称为“SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS”的美国申请序列号13/118,241(现为美国专利申请公布2012/0298719)的全部公开内容以引用方式并入本文。Various embodiments described herein are described in the context of a linear end effector and/or a linear fastener cartridge. Such embodiments and their teachings are applicable to nonlinear end effectors and/or nonlinear fastener cartridges, such as circular and/or contoured end effectors. For example, U.S. Patent Application Serial No. 13/036,647 (now U.S. Patent Application Publication 2011/ 0226837), which is hereby incorporated by reference in its entirety. Additionally, US Patent Application Serial No. 12/893,461, entitled "STAPLE CARTRIDGE," filed September 29, 2012 (now US Patent Application Publication 2012/0074198), is hereby incorporated by reference in its entirety. US Patent Application Serial No. 12/031,873, filed February 15, 2008, entitled "END EFFECTORS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT" (now US Patent 7,980,443), is also hereby incorporated by reference in its entirety. The entire disclosure of US Patent 7,845,537, issued December 7, 2010, entitled "SURGICAL INSTRUMENT HAVING RECORDING CAPABILITIES," is incorporated herein by reference in its entirety. The entire disclosure of U.S. Application Serial No. 13/118,241, entitled "SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS," filed May 27, 2011 (now U.S. Patent Application Publication 2012/0298719), is incorporated herein by reference.
可将本文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。然而无论是哪种情况，该装置都可在至少使用一次后经过修复再行使用。重新修复可包括以下步骤中的任意组合：拆卸该装置、然后清洗或更换特定零件、以及随后重新组装。具体地，该装置可以拆卸，并且可以任意组合选择性地置换或移除任意数目的特定部件或零件。清洗和/或更换特定零件后，该装置可以在修复设施处重新组装以便随后使用，或者在即将进行外科手术前由外科团队重新组装。本领域的技术人员应当理解，装置的重新修复可利用多种用于拆卸、清洗/更换和重新组装的技术。此类技术的用途以及所得的重新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 can be disassembled and any number of specific components or parts can be selectively replaced or removed in any combination. After cleaning and/or replacement of certain parts, the device can be reassembled for subsequent use at a reconditioning facility, or by the 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 such techniques, as well as the resulting reconditioning devices, are within the scope of the present invention.
优选的是，将在手术前处理本文所述的发明。首先，获取新的或用过的器械，并根据需要进行清洗。然后可对器械进行灭菌。在一种灭菌技术中，将该器械放置在闭合且密封的容器中，诸如塑料或TYVEK袋中。然后将容器和器械放置在可穿透该容器的辐射场诸如γ辐射、x-射线或高能电子中。辐射杀死器械上和容器中的细菌。然后可将灭菌后的器械储存在无菌容器中。该密封容器使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 processed prior to surgery. First, obtain new or used instruments and clean them as needed. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument are then placed in a radiation field that can penetrate the container, such as gamma radiation, x-rays, or high energy electrons. Radiation kills bacteria on instruments and in containers. The sterilized instrument can then be stored in the sterile container. 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、公布或其他公开材料均仅在所并入的材料不与本公开所述的现有定义、陈述或其他公开材料相冲突的范围内并入本文。因此，并且在必要的程度下，本文明确阐述的公开内容取代以引用方式并入本文的任何冲突材料。任何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，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, publication, or other disclosure material incorporated herein by reference in whole or in part is incorporated only to the extent that the incorporated material does not conflict with a prior definition, statement, or other disclosure material set forth in this disclosure. This article. Accordingly, and 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 incorporated herein by reference but conflicts with existing definitions, statements, or other disclosed material described herein, only to the extent that no conflict arises between the incorporated material and the existing disclosed material Incorporated into this article to a certain extent.
尽管本发明已被描述为具有示例性的设计，但还能够在本公开的实质和范围内对本发明进行修改。因此本申请旨在涵盖采用本发明一般原理的任何变型、用途或修改型式。另外，本申请旨在涵盖本发明所属领域中属于已知或惯有实践范围内的与本公开不同的此类型式。While this invention has been described as having an exemplary design, the present invention is capable of modifications within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses or modifications of the general principles of the invention. Further, this application is intended to cover such variations from the present disclosure as come within known or customary practice in the art to which this invention pertains.
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| US14/187,395 | 2014-02-24 | ||
| PCT/US2015/015101WO2015126656A1 (en) | 2014-02-24 | 2015-02-10 | Staple cartridge including a barbed staple |
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| CN106232031Atrue CN106232031A (en) | 2016-12-14 |
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| CN201580020865.7APendingCN106232031A (en) | 2014-02-24 | 2015-02-10 | Nail bin including the nail of band barb |
| Country | Link |
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| JP (1) | JP2017506145A (en) |
| CN (1) | CN106232031A (en) |
| AU (2) | AU2015219430A1 (en) |
| BR (1) | BR112016019008A8 (en) |
| CA (1) | CA2940159A1 (en) |
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| Date | Code | Title | Description |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| WD01 | Invention patent application deemed withdrawn after publication | Application publication date:20161214 | |
| WD01 | Invention patent application deemed withdrawn after publication |