技术领域technical field
本发明涉及医疗器械技术领域，具体涉及一种适用于管状瘘的肠瘘支架套件。The invention relates to the technical field of medical instruments, in particular to an intestinal fistula support set suitable for tubular fistula.
背景技术Background technique
肠瘘是指在肠与其他器官，或肠与腹腔、腹壁外有不正常的通道，前者称内瘘，后者为外瘘。肠瘘造成肠内容物流出肠腔，引起感染、体液丢失、营养不良和器官功能障碍等一系列病理生理改变。肠瘘是腹部外科严重并发症之一，由于创伤、手术损伤、严重腹腔感染，慢性肠道炎症及肿瘤等原因所致。Intestinal fistula refers to an abnormal channel between the intestine and other organs, or between the intestine and the abdominal cavity or outside the abdominal wall. The former is called internal fistula, and the latter is called external fistula. Intestinal fistula causes intestinal content to flow out of the intestinal cavity, causing a series of pathophysiological changes such as infection, fluid loss, malnutrition, and organ dysfunction. Intestinal fistula is one of the serious complications of abdominal surgery, which is caused by trauma, surgical injury, severe abdominal infection, chronic intestinal inflammation and tumor.
肠瘘的治疗一直是胃肠内外科临床的一个难题。感染未能得到有效控制，感染及感染引发的多器官功能障碍综合征是治疗失败的主要因素，占死亡病人的90%。而控制腹部感染的首要举措是充分的引流与瘘口部位的旷置，引流的目的是引流肠液、脓液和坏死组织，减少对瘘管和瘘口的进一步侵蚀，使瘘口瘘管缩小以便于封堵或者自愈。目前临床上多采用腹腔内置入引流管引流及手术治疗。但由于消化液生理分泌量大（成人24小时分泌消化液超过10L），目前临床上多使用瘘口旁放置硅胶管引流，但引流方式效果不佳，且硅胶管可能对邻近肠壁刺激压迫，影响肠道蠕动及肠壁血运，长时间留置可能导致压迫处出现新的肠瘘（医源性肠瘘）；其次目前临床上采用的为外引流，大量消化液及营养物质丢失导致内环境紊乱及营养不良，严重影响病人的预后，总之目前临床针对肠瘘的治疗，周期长，费用高，疗效不尽人意。The treatment of intestinal fistula has always been a difficult problem in gastrointestinal surgery. Infection has not been effectively controlled. Infection and infection-induced multiple organ dysfunction syndrome are the main factors of treatment failure, accounting for 90% of death patients. The primary measure to control abdominal infection is adequate drainage and evacuation of the fistula site. The purpose of drainage is to drain intestinal fluid, pus and necrotic tissue, reduce further erosion of the fistula and fistula opening, and shrink the fistula opening for easy sealing. blocked or self-healing. At present, intraperitoneal drainage and surgical treatment are mostly used clinically. However, due to the large amount of physiological secretion of digestive juice (adults secrete more than 10L of digestive juice in 24 hours), silicone tubes are often used for drainage beside the fistula in clinical practice, but the drainage method is not effective, and the silicone tube may stimulate and oppress the adjacent intestinal wall. Affect intestinal peristalsis and intestinal wall blood supply, long-term indwelling may lead to new intestinal fistula (iatrogenic intestinal fistula) at the compression site; secondly, external drainage is currently used clinically, and a large amount of digestive juice and nutrients are lost leading to internal environment Disorder and malnutrition seriously affect the prognosis of patients. In short, the current clinical treatment for intestinal fistula has a long cycle, high cost and unsatisfactory curative effect.
发明内容Contents of the invention
为实现上述目的，本发明所提供的技术方案是：一种肠瘘支架套件，其包括In order to achieve the above object, the technical solution provided by the present invention is: an intestinal fistula stent set, which includes
肠内气囊架，置入肠道通过供气膨胀以对肠壁进行支撑；Intestinal balloon frame, inserted into the intestinal tract and inflated by air supply to support the intestinal wall;
肠外包覆层，包覆在肠道外，通过与肠内气囊架相配合实现相互定位；The parenteral coating layer covers the outside of the intestinal tract and realizes mutual positioning by cooperating with the intestinal air bag frame;
多腔连接管，具有皮肤固定器、吸引管路、气囊管路和注入管路，皮肤固定器用于固定限位在皮肤上，吸引管路用于吸引肠液，气囊管路用于导气，注入管路用于注射；Multi-lumen connecting tube, with skin fixer, suction line, balloon line and injection line, the skin fixer is used to fix and limit on the skin, the suction line is used to attract intestinal fluid, the balloon line is used to guide air, and inject tubing for injection;
肠液回收模组，用于回收经吸引管路流出的肠液；The intestinal fluid recovery module is used to recover the intestinal fluid flowing out through the suction line;
供气模组，用于通过气囊管路为肠内气囊架供气。The air supply module is used for supplying air to the enteral air bag holder through the air bag pipeline.
作为本发明的一种改进，所述肠内气囊架为一管状气囊，该管状气囊的一端管径较小，另一端管径呈逐渐增大状。As an improvement of the present invention, the intestinal airbag holder is a tubular airbag, one end of the tubular airbag has a smaller diameter, and the other end has a gradually increasing diameter.
作为本发明的一种改进，所述管状气囊的管径较大的一端朝向肠道消化食物方向。As an improvement of the present invention, the end of the tubular airbag with a larger diameter faces the direction of digesting food in the intestinal tract.
作为本发明的一种改进，所述肠内气囊架的两端部位处涂覆有内磁吸材料。As an improvement of the present invention, the two ends of the enteral airbag frame are coated with internal magnetic materials.
作为本发明的一种改进，所述肠外包覆层包括由内至外依次叠置的海绵层和柔性密封膜层。As an improvement of the present invention, the parenteral covering layer includes a sponge layer and a flexible sealing film layer stacked in sequence from the inside to the outside.
作为本发明的一种改进，所述肠外包覆层的两端部位处涂覆有能与所述内磁吸材料相吸附的外磁吸材料。As an improvement of the present invention, both ends of the parenteral coating layer are coated with an outer magnetic material capable of being adsorbed to the inner magnetic material.
作为本发明的一种改进，所述多腔连接管包括皮肤固定器及多腔管体，皮肤固定器上设有用连接套，多腔管体贯穿连接套设置在皮肤固定器上，所述多腔管体内设有隔管壁形成相互独立的吸引管路、气囊管路和注入管路。As an improvement of the present invention, the multi-lumen connecting tube includes a skin fixator and a multi-lumen tube body, the skin fixator is provided with a connecting sleeve, and the multi-lumen tube body is arranged on the skin fixator through the connecting sleeve. A septum tube wall is arranged in the lumen to form mutually independent suction pipelines, air bag pipelines and injection pipelines.
作为本发明的一种改进，所述肠液回收模组包括密封腔体及半透膜，该半透膜横向设置在密封腔体内使该密封腔体的内腔上部形成废弃物腔，内腔下部形成回收液腔；密封腔体的顶面上设有负压接口和吸引接口。As an improvement of the present invention, the intestinal juice recovery module includes a sealed cavity and a semi-permeable membrane. The semi-permeable membrane is arranged laterally in the sealed cavity so that the upper part of the inner cavity of the sealed cavity forms a waste cavity, and the lower part of the inner cavity A recovery liquid chamber is formed; a negative pressure port and a suction port are provided on the top surface of the sealed chamber.
作为本发明的一种改进，所述供气模组包括打气泵、连接管道和排气阀，连接管道的一端与打气泵相连接，另一端与气囊管路相连接，所述排气阀设置在连接管道上。As an improvement of the present invention, the air supply module includes an air pump, a connecting pipeline and an exhaust valve, one end of the connecting pipeline is connected to the air pump, and the other end is connected to the air bag pipeline, and the exhaust valve is set on the connecting pipe.
作为本发明的一种改进，所述供气模组还包括有测压表，该测压表设置在连接管道上。As an improvement of the present invention, the air supply module further includes a pressure gauge, which is arranged on the connecting pipeline.
本发明的有益效果为：本发明结构设计巧妙、合理，在瘘口部位置入肠内气囊架，对应肠内气囊架的位置再将肠外包覆层包覆在肠道外，通过供使肠内气囊架膨胀扩张，大大提高引流效果，彻底旷置瘘口部位，不影响消化液正常通过瘘口位置的同时，保证了瘘口部位的清洁性，给瘘口部位的愈合提供了时间，缩短了治疗时间；而且由于是采用内引流方式，最大程度减少消化液及营养物质的丢失，有利于病人维持内环境稳定及瘘口的愈合；另外多腔连接管能方便固定限位在皮肤上，避免了移位或者滑动，给手术操作带来方便，有效减轻病人的痛苦，节约医疗成本与资源，利于广泛推广应用。The beneficial effects of the present invention are: the structural design of the present invention is ingenious and reasonable, and the intestinal air bag frame is placed at the position of the fistula, and the parenteral coating layer is coated on the outside of the intestinal tract corresponding to the position of the intestinal air bag frame, through which the intestinal The internal air bag frame expands and expands, greatly improving the drainage effect, completely evacuating the fistula site, without affecting the normal passage of digestive fluid through the fistula site, and at the same time ensuring the cleanliness of the fistula site, providing time for the healing of the fistula site, shortening the The treatment time is shortened; and because the internal drainage method is adopted, the loss of digestive juice and nutrients is minimized, which is conducive to maintaining the stability of the internal environment of the patient and the healing of the fistula; in addition, the multi-lumen connecting tube can be conveniently fixed and limited on the skin, It avoids displacement or sliding, brings convenience to operation, effectively relieves pain of patients, saves medical costs and resources, and is conducive to wide popularization and application.
下面结合附图与实施例，对本发明进一步说明。The present invention will be further described below in conjunction with the accompanying drawings and embodiments.
附图说明Description of drawings
图1是本发明的整体结构示意图。Fig. 1 is a schematic diagram of the overall structure of the present invention.
图2是本发明中肠内气囊架和肠外包覆层的剖视结构示意图。Fig. 2 is a schematic cross-sectional structure diagram of the intestinal airbag frame and the parenteral coating layer in the present invention.
图3是本发明中肠内气囊架的结构示意图。Fig. 3 is a schematic diagram of the structure of the air bag holder in the intestine of the present invention.
图4是本发明中肠外包覆层的结构示意图。Fig. 4 is a schematic diagram of the structure of the parenteral coating layer in the present invention.
图5是本发明中供气模组的结构示意图。Fig. 5 is a schematic structural diagram of the air supply module in the present invention.
图6是本发明中多腔连接管的结构示意图。Fig. 6 is a schematic structural view of the multi-lumen connecting tube in the present invention.
图7是本发明中肠液回收模组的结构示意图。Fig. 7 is a schematic structural view of the midgut fluid recovery module of the present invention.
具体实施方式Detailed ways
参见图1和图7，本实施例提供的一种肠瘘支架套件，其包括肠内气囊架1、肠外包覆层2、多腔连接管3、肠液回收模组4和供气模组5。Referring to Fig. 1 and Fig. 7, an intestinal fistula stent kit provided in this embodiment includes an enteral air bag holder 1, a parenteral coating layer 2, a multi-lumen connecting tube 3, an intestinal fluid recovery module 4 and an air supply module 5.
参见图2，所述肠内气囊架1为一管状气囊，该管状气囊的一端管径较小，另一端管径呈逐渐增大状。其中所述管状气囊的管径较大的一端朝向肠道6消化食物方向，能有效减少肠壁运动对于肠内气囊架1的作用力，提升放置的稳定性。图2中的箭头表示肠道消化食物方向。Referring to FIG. 2 , the enteral airbag holder 1 is a tubular airbag, one end of the tubular airbag has a smaller diameter, and the other end has a gradually increasing diameter. The end of the tubular airbag with a larger diameter faces the direction of the intestinal tract 6 to digest food, which can effectively reduce the force of intestinal wall movement on the intestinal airbag holder 1 and improve the stability of placement. The arrows in Figure 2 indicate the direction of food digestion in the gut.
参见图3，所述肠内气囊架1的两端部位处涂覆有内磁吸材料11。参见图4，在所述肠外包覆层2的两端部位处涂覆有能与所述内磁吸材料11相吸附的外磁吸材料21。通过内磁吸材料11与外磁吸材料21相吸附，实现将肠外包覆层2固定。较佳的，所述肠外包覆层2包括由内至外依次叠置的海绵层和柔性密封膜层。海绵层是起到作用力缓冲的作用，柔性密封膜层是包覆在海绵层上，能防止海绵吸水和各种液体。Referring to FIG. 3 , both ends of the enteral airbag frame 1 are coated with an internal magnetic material 11 . Referring to FIG. 4 , both ends of the parenteral coating 2 are coated with an outer magnetic material 21 capable of being adsorbed to the inner magnetic material 11 . The parenteral covering layer 2 is fixed by the adsorption of the inner magnetic material 11 and the outer magnetic material 21 . Preferably, the parenteral covering layer 2 includes a sponge layer and a flexible sealing film layer stacked in sequence from the inside to the outside. The sponge layer acts as a force buffer, and the flexible sealing film layer is coated on the sponge layer, which can prevent the sponge from absorbing water and various liquids.
参见图5，所述供气模组5包括打气泵51、连接管道52、排气阀53和测压表54，连接管道52的一端与打气泵51相连接，另一端与气囊管路322相连接，所述排气阀53和测压表54设置在连接管道52上。5, the air supply module 5 includes an air pump 51, a connecting pipe 52, an exhaust valve 53 and a pressure gauge 54. One end of the connecting pipe 52 is connected to the air pump 51, and the other end is connected to the air bag pipeline 322. The exhaust valve 53 and the pressure gauge 54 are arranged on the connecting pipe 52 .
参见图6，所述多腔连接管3包括皮肤固定器31及多腔管体32，皮肤固定器31上设有用连接套，多腔管体32贯穿连接套设置在皮肤固定器31上，所述多腔管体32内设有隔管壁形成相互独立的吸引管路321、气囊管路322和注入管路323。 所述多腔管体32的横截面外形轮廓优选为圆形，能减少对于皮肤切口的损伤。皮肤固定器31呈薄片状，方便用各种医用胶带与皮肤固定，达到固定多腔管体32的效果，使用简单方便。Referring to Fig. 6, the multi-lumen connecting tube 3 includes a skin fixator 31 and a multi-lumen tube body 32, the skin fixator 31 is provided with a connecting sleeve, and the multi-lumen tube body 32 runs through the connecting sleeve and is arranged on the skin fixator 31. The multi-lumen tube body 32 is provided with septum walls to form a suction pipeline 321 , a balloon pipeline 322 and an injection pipeline 323 which are independent of each other. The cross-sectional profile of the multi-lumen tube body 32 is preferably circular, which can reduce damage to the skin incision. The skin fixer 31 is in the shape of a sheet, which is convenient to fix with the skin with various medical adhesive tapes to achieve the effect of fixing the multi-lumen tubular body 32, and is simple and convenient to use.
参见图7，所述肠液回收模组4包括密封腔体41及半透膜42，该半透膜42横向设置在密封腔体41内使该密封腔体41的内腔上部形成废弃物腔411，内腔下部形成回收液腔412；密封腔体41的顶面上设有负压接口43和吸引接口44。吸引接口44与吸引管路321相连接。负压接口43与抽气泵相连接。Referring to Fig. 7, the intestinal fluid recovery module 4 includes a sealed cavity 41 and a semi-permeable membrane 42, the semi-permeable membrane 42 is arranged laterally in the sealed cavity 41 so that the upper part of the sealed cavity 41 forms a waste cavity 411 , the lower part of the inner cavity forms a recovery liquid cavity 412; the top surface of the sealed cavity 41 is provided with a negative pressure port 43 and a suction port 44. The suction interface 44 is connected with the suction pipeline 321 . Negative pressure interface 43 is connected with air pump.
操作时，在腹壁切口建立通道，建立气腹，将肠内气囊架1由体外放入体内，并通过瘘口放入肠道6内，启动供气模组5对肠内气囊架1进行充气。然后对应肠内气囊架1的位置将肠外包覆层2包覆在肠道6外，使其与肠内气囊架1进行对应实现相互定位固定。用医用胶带将皮肤固定器31粘贴在皮肤上进行固定。其中将注入管路323引入肠内。吸引管路321与肠外包覆层2相连接，能透过海绵层来吸附瘘口部位的肠液及各种液体，肠液及各种液体由吸引管路321流出至肠液回收模组4进行回收。气囊管路322与启动供气模组5相连接。待瘘口部位愈合后，从皮肤固定器31的开口处取出肠外包覆层2，打开排气阀53，将肠内气囊架1的气体排出，切断气囊管路322和注入管路323，肠内气囊架1和注入管路323从肠道6内排出体外。During the operation, a channel is established through an incision in the abdominal wall to establish pneumoperitoneum, the intestinal air bag holder 1 is put into the body from outside the body, and put into the intestinal tract 6 through the fistula opening, and the air supply module 5 is activated to inflate the intestinal air bag holder 1 . Then, the parenteral coating layer 2 is coated on the outside of the intestinal tract 6 corresponding to the position of the intestinal air bag frame 1 so as to correspond to the intestinal air bag frame 1 to achieve mutual positioning and fixing. Stick the skin fixator 31 on the skin with medical tape for fixing. In it, an infusion line 323 is introduced into the intestine. The suction line 321 is connected to the parenteral coating 2, and can absorb the intestinal juice and various liquids at the fistula site through the sponge layer, and the intestinal juice and various liquids flow out from the suction line 321 to the intestinal juice recovery module 4 for recovery . The air bag pipeline 322 is connected with the starting air supply module 5 . After the fistula site is healed, take out the parenteral coating 2 from the opening of the skin fixator 31, open the exhaust valve 53, discharge the gas of the intestinal air bag holder 1, cut off the air bag pipeline 322 and the injection pipeline 323, The intestinal air bag holder 1 and the injection pipeline 323 are discharged from the intestinal tract 6 outside the body.
根据上述说明书的揭示和教导，本发明所属领域的技术人员还可以对上述实施方式进行变更和修改。因此，本发明并不局限于上面揭示和描述的具体实施方式，对本发明的一些修改和变更也应当落入本发明的权利要求的保护范围内。此外，尽管本说明书中使用了一些特定的术语，但这些术语只是为了方便说明，并不对本发明构成任何限制。如本发明上述实施例所述，采用与其相同或相似的结构而得到的其它套件，均在本发明保护范围内。According to the disclosure and teaching of the above-mentioned specification, those skilled in the art to which the present invention belongs can also make changes and modifications to the above-mentioned embodiment. Therefore, the present invention is not limited to the specific embodiments disclosed and described above, and some modifications and changes to the present invention should also fall within the protection scope of the claims of the present invention. In addition, although some specific terms are used in this specification, these terms are only for convenience of description and do not constitute any limitation to the present invention. As described in the above embodiments of the present invention, other kits obtained by adopting the same or similar structures are within the protection scope of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810805108.6ACN108619586A (en) | 2018-07-20 | 2018-07-20 | Intestinal Fistula Stent Kit |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810805108.6ACN108619586A (en) | 2018-07-20 | 2018-07-20 | Intestinal Fistula Stent Kit |
| Publication Number | Publication Date |
|---|---|
| CN108619586Atrue CN108619586A (en) | 2018-10-09 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810805108.6APendingCN108619586A (en) | 2018-07-20 | 2018-07-20 | Intestinal Fistula Stent Kit |
| Country | Link |
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| CN (1) | CN108619586A (en) |
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| Date | Code | Title | Description |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | Application publication date:20181009 | |
| RJ01 | Rejection of invention patent application after publication |