Gastrointestinal stent

Abstract

The application relates to the field of medical devices, and particularly discloses a digestive tract stent, which comprises a stent body and a fixing mechanism. The stent body is a hollow tubular member. The fixing mechanism is fixed to at least one end of the stent body in the axial direction and protrudes from the outer circumferential surface of the stent body in the radial direction. According to the technical scheme, the fixing mechanism makes the position of the stent body in the digestive tract more stable, thereby improving the reliability of the digestive tract stent in the treatment of anastomotic stoma related complications.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, and more particularly, to a digestive tract stent. BACKGROUND

[0002] Esophageal cancer is a high-incidence malignant tumor worldwide. The most common treatment for esophageal cancer is surgery, mainly including subtotal esophagectomy, subtotal proximal gastrectomy, and esophagogastric anastomosis. However, postoperative complications such as anastomotic fistula and anastomotic stenosis can seriously affect the life safety, prognosis, and quality of life of patients with esophageal cancer.

[0003] Traditionally, esophagogastric anastomosis is performed by manual anastomosis, which is time-consuming, complicated, and has a high incidence of anastomotic fistula. Although mechanical anastomosis with an anastomosis device can reduce the incidence of anastomotic fistula to some extent, some patients still develop anastomotic fistula, anastomotic stenosis, and other anastomotic complications due to various reasons. Therefore, it is urgent to reduce the incidence and mortality of anastomotic fistula, anastomotic stenosis, and other anastomotic complications in esophageal cancer and digestive tract surgery, and to improve the prognosis and postoperative quality of life of patients.

[0004] To improve the life safety, prognosis, and quality of life of patients with anastomotic fistula, modern medicine has proposed a treatment method of implanting an esophageal stent. However, the existing medical stents on the market mainly have the technical problem of easy shedding, which leads to a high probability of anastomotic complications.

[0005] Therefore, it is a technical problem in the field to provide a digestive tract stent with higher reliability to reduce the probability of complications. SUMMARY

[0006] Therefore, the present application proposes a digestive tract stent with an auxiliary fixing device to achieve a treatment method that can be reliably applied to anastomotic complications.

[0007] According to the present application, a digestive tract stent is proposed, which comprises: a stent body, which is a hollow tubular member; and a fixing mechanism, which is fixed to at least one end of the stent body in the axial direction and protrudes from the outer circumferential surface of the stent body in the radial direction of the stent body.

[0008] Preferably, the stent body and the fixing mechanism are integrally formed.

[0009] Preferably, the stent body and / or the fixing mechanism are made of metal or degradable non-metallic materials.

[0010] Preferably, the surface of the stent body and / or the fixing mechanism is covered with a drug-eluting coating.

[0011] Preferably, the drug-eluting coating comprises a drug-loading layer comprising one or more of the following drugs: sirolimus, glucocorticoid, mitomycin, paclitaxel, paclitaxel derivative, dactinomycin, 5-fluorouracil, rapamycin.

[0012] Preferably, the stent body is one or more of a tubular structure, a mesh structure, and a spiral structure.

[0013] Preferably, the stent body has a cross-sectional diameter of 5mm to 30mm, preferably 10mm to 20mm, and / or an axial length of 5mm to 100mm, preferably 10mm to 20mm.

[0014] Preferably, the stent body has at least one anti-dislodging structure formed on the outer circumferential surface thereof, the anti-dislodging structure protruding from the outer circumferential surface of the stent body.

[0015] Preferably, the anti-dislodging structure comprises: a protruding portion protruding radially outward from the outer circumferential surface of the stent body; and / or a granular or corrugated rough surface formed on the outer circumferential surface of the stent body.

[0016] Preferably, the fixation mechanism comprises a first fixation member disposed at the end edge of the stent body and protruding radially outward, for forming a fixed fit with the digestive tract wall.

[0017] Preferably, the fixation mechanism comprises a connecting rod extending from one end of the stent body, and the first fixation member is mounted at the end of the connecting rod.

[0018] Preferably, the length of the connecting rod is adjustable.

[0019] Preferably, the connecting rod extends in the axial direction; or the extension direction of the connecting rod deviates from the axial direction, so that the first fixation member is away from the stent body in the radial direction of the stent body.

[0020] Preferably, the first fixation member comprises one or more of the following structure forms: a mounting seat for mounting and fixing with a thumbtack member, rivet member, screw member, or button from the outside of the esophagus penetrating the digestive tract wall; a thumbtack member, rivet member, screw member, or button for penetrating the digestive tract wall and being fixed outside the digestive tract wall by a corresponding mounting seat; and a suture hole for being sutured to the digestive tract wall by a suture.

[0021] Preferably, one or more of the fixation mechanisms are provided at both ends of the stent body in the axial direction, and the one or more fixation mechanisms are uniformly or non-uniformly distributed around the circumferential direction of the stent body.

[0022] Preferably, the gastrointestinal stent is cooperated with an external binding member for binding the gastrointestinal wall to the stent body on the outer surface of the gastrointestinal tract.

[0023] Preferably, the external binding member comprises a sleeve, which, with the stent body supporting the gastrointestinal wall inside the gastrointestinal tract, is wrapped or wound on the outer side of the gastrointestinal wall.

[0024] Preferably, the sleeve is made of a biocompatible fully degradable material or a non-degradable material, and the degradation period of the sleeve is greater than or equal to the degradation period of the stent body and the fixing mechanism.

[0025] Preferably, the sleeve comprises a flexible surface and a second fixing end provided on the flexible surface, which is penetrated by one of the first fixing members and fixedly installed with the other one of the first fixing members.

[0026] Preferably, the stent body of the gastrointestinal stent is provided with an anti-reflux mechanism, which is used to allow the flow of fluid or solid in the stent body towards a first axial direction and prevent or reduce the flow of fluid or solid in the stent body towards a second axial direction.

[0027] Preferably, the anti-reflux mechanism comprises at least one flexible flow guide piece, which is fixed to the inner circumferential surface of the stent body.

[0028] Preferably, the flexible flow guide piece extends or bends towards the first axial direction.

[0029] Preferably, the anti-reflux mechanism comprises: a plurality of flexible flow guide pieces distributed on different cross sections in the axial direction of the gastrointestinal wall; and / or a plurality of flexible flow guide pieces distributed on the same cross section in the axial direction of the gastrointestinal wall.

[0030] Preferably, between the flexible flow guide pieces distributed on the same cross section in the axial direction of the gastrointestinal wall, there is a flow guide opening, which comprises two states: when fluid or solid moves towards the first axial direction, a plurality of flexible flow guide pieces are deformed towards the first axial direction under the pushing of the fluid or solid, and the flow guide opening is opened; and when there is no fluid or solid passing through, or when fluid or solid moves towards the second axial direction, the flexible flow guide pieces restore their shape under the action of their own elastic force, and the flow guide opening is closed.

[0031] According to the technical solution of the present application, after the stent body of the digestive tract stent is unfolded in the digestive tract, the stent body is supported on the inner wall of the digestive tract, the stent body and the wall of the digestive tract are further fixed by the fixing mechanism fixed to at least one end of the stent body in the axial direction, so that the position of the stent body in the digestive tract is more stable, and the reliability of the digestive tract stent is improved.

[0032] Other features and advantages of the present application will be described in detail in the following specific embodiments. BRIEF DESCRIPTION OF DRAWINGS

[0033] The accompanying drawings, which form a part of the present application, are intended to provide further understanding of the present application, and the illustrative embodiments of the present application and their description serve the purpose of explaining the present application. In the drawings:

[0034] Figure 1 is a perspective view of the digestive tract stent according to the preferred embodiment of the present application;

[0035] Figure 2 , Figure 3 and Figure 4 are schematic views of other alternative embodiments of the digestive tract stent of the present application;

[0036] Figure 5 is a schematic view of the digestive tract stent shown in Figure 4 in a flexible and extended state in the digestive tract;

[0037] Figure 6 is an enlarged view of part C of Figure 1 ;

[0038] Figure 7 is a schematic view of the digestive tract stent shown in Figure 1 with a protruding portion and a barb;

[0039] Figure 8 is a perspective view of Figure 1 ;

[0040] Figure 9 is a top view of Figure 1 ;

[0041] Figure 10 is an A-A sectional view of Figure 9 ;

[0042] Figure 11 is a schematic view of a sleeve;

[0043] Figure 12 and Figure 13 are partial schematic views of the digestive tract stent in a mounted state with a sleeve;

[0044] Figure 14A schematic diagram of the digestive tract stent according to the present application is placed in the esophagus in a digestive tract surgery. DETAILED DESCRIPTION

[0045] The clinical application of the digestive tract stent is an important milestone in the development history of digestive tract interventional therapy in recent years. In clinical practice, according to different lesion positions, the corresponding digestive tract stent can effectively reconstruct the patency of the digestive tract, and open up a new treatment approach for diseases that are intractable to traditional surgery. In the present application, the esophageal stent is taken as an example, and a more reliable digestive tract stent for anastomotic related complications is provided in view of the problem of easy shedding of the traditional esophageal stent. It can be understood that the digestive tract stent of the present application is described by taking the esophageal stent as an example, but the present application is not limited to this esophageal stent, and can also be used for gastric and duodenal stents, colorectal stents, and other digestive tract surgical or interventional / endoscopic hybrid surgical treatments after corresponding selection according to the actual application working conditions.

[0046] The technical solutions of the present application will be described in detail below with reference to the accompanying drawings and in conjunction with the embodiments.

[0047] As shown in Figure 1 , Figure 2 , Figure 3 and Figure 4 , the digestive tract stent of the present application comprises a stent body 10, which is a hollow tubular member. The tubular member can be a circular tube, an elliptical tube or other shapes that can easily fit the inner wall of the digestive tract. The tubular member can be any one of an integrally formed tubular structure, a mesh structure and a spiral or cross spiral structure, or can be formed by combining any of the above structures to form the hollow tubular member.

[0048] Due to the spontaneous peristalsis of the digestive tract or the patient's eating, the stent is prone to slipping or displacement, which in turn causes related complications. In traditional esophageal stents, in order to avoid the slipping or displacement of the esophageal stent, the esophageal stent is expanded to generate an interaction force between the esophageal wall and the esophageal wall, so as to achieve the attachment of the stent. However, in actual operation, the effect is not satisfactory, and the reason is that during the swallowing process of the patient, the peristalsis of the esophageal wall and the food passing through the stent can cause the movement of the stent.

[0049] In the present application, in order to improve the reliability of the digestive tract stent, the digestive tract stent of the present application further comprises a fixing mechanism 20, which is directly fixed and connected with the digestive tract by the digestive tract stent in use. As shown in Figures 1 to 4 , the fixing mechanism 20 is fixed to at least one end of the stent body 10 in the axial direction, and as shown in Figure 9As shown, the fixing mechanism 20 protrudes from the outer peripheral surface of the stent body 10 in the radial direction. Compared with traditional digestive tract stents, this application further enhances the reliable positioning performance between the digestive tract stent and the digestive tract wall through the fixing mechanism 20. During use, the digestive tract stent is directly fixed to the digestive tract using the fixing mechanism 20, rather than being limited to the adhesion relationship between the stent body 10 and the digestive tract wall based on interaction forces, thereby overcoming the problem of easy slippage.

[0050] Depending on the working conditions, a fixing mechanism 20 can be provided at one end of the stent body 10. For example, a fixing mechanism 20 can be provided at the upstream end in the direction of food swallowing when the digestive tract stent is in place, so as to prevent the upstream end of the stent from moving along the food movement direction when swallowed food passes through the digestive tract stent; or a fixing mechanism 20 can be provided at the downstream end in the direction of food swallowing when the digestive tract stent is in place, so as to prevent the downstream end of the digestive tract stent from moving towards the oral cavity due to vomiting or dry heaving after the patient perceives a foreign object. Preferably, fixing mechanisms 20 are provided at both ends of the stent body 10 in the axial direction, so as to fix the upstream end and the downstream end by fixing mechanisms 20 at both ends of the stent body 10, so as to help the stent body 10 maintain its shape while keeping its placement position unchanged.

[0051] The fixing mechanism 20 provided at either the upstream end or the downstream end of the support body 10 can be one or more. Preferably, multiple fixing mechanisms 20 are provided at both ends of the support body 10 in the axial direction. These multiple fixing mechanisms 20 are evenly or unevenly distributed around the circumferential direction of the support body 10, thereby sharing the load of fixing the support body 10 and improving the fixing strength of the fixing mechanism 20.

[0052] Based on the above-mentioned digestive tract stent, such as Figure 5 As shown, after unfolding within the digestive tract, the stent body 10, based on its own flexibility, is released and supported on the inner wall of the digestive tract. The fixation mechanism 20 forms auxiliary fixation with the inner wall of the digestive tract at both ends to enhance the fixation effect. The stent body 10 and fixation mechanism 20 of the digestive tract stent can be separately configured, with the fixation mechanism 20 selectively installed on the stent body 10 only in actual application according to the patient's actual situation or surgical procedure; or, preferably, the stent body 10 and fixation mechanism 20 are made as a single unit, thereby simplifying the stent placement operation and providing higher reliability compared to separate configurations.

[0053] The material of the stent body 10 and the fixing mechanism 20 can be the same or different, and can be medical stainless steel, nickel-titanium alloy, tantalum or ultra-thin channel steel, etc. Preferably, the stent body 10 and / or the fixing mechanism 20 are made of metal (including but not limited to: iron-based, magnesium-based, platinum, platinum-tungsten, platinum-iridium, nickel-titanium or cobalt-chromium alloy, etc.) or degradable non-metallic materials to achieve good biocompatibility. Especially, the degradable non-metallic materials can be completely degraded after short-term shaping in the digestive tract, thereby further avoiding complications caused by long-term placement of traditional permanent stents. The degradable non-metallic materials can include: natural degradable polymer materials such as hyaluronic acid, chitosan, chitin, cellulose, heparin, collagen and gelatin, etc.; microbially synthesized polymer materials such as polylactide, polycaprolactone and polyethylene glycol, etc.; and synthetic degradable polymer materials such as polylactide, polyglycolide and polycaprolactone, etc. According to the actual application environment and the condition of the patient, the material of the digestive tract stent of the present application can include one or more of the above-mentioned degradable metal materials and non-metallic materials, and the degradation period can be adjusted by selecting different materials and proportions. The degradation period can be 1 month to 36 months, and for example, for a patient with esophageal anastomotic fistula secondary to anastomotic stenosis, the degradation period of the stent body 10 and / or the fixing mechanism 20 is preferably 3-12 months.

[0054] The digestive tract stent of the present application preferably further has a film (not shown in the figure) on the surface of the stent body 10 and / or the fixing mechanism 20, which preferably includes a drug loading layer to load drugs for providing local release of drugs to the patient. The drug loading layer can include one or more of the following drugs: sirolimus, glucocorticoid, mitomycin, paclitaxel, paclitaxel derivative, dactinomycin, 5-fluorouracil, rapamycin. For patients with different conditions, one or more of the above drugs can be selected and combined to form the drug loading layer, for example, the drugs loaded for malignant tumor patients can be selected from the above-mentioned chemotherapy drugs, and chemotherapy drugs are avoided for children and patients with benign diseases. By loading the corresponding drugs through the above-mentioned drug loading layer to control drug release, smooth muscle cell proliferation and migration can be effectively inhibited, and digestive tract stenosis caused by granulation proliferation at the end of the stent due to stimulation of the stent to the digestive tract and / or peristalsis of the digestive tract can be avoided.

[0055] The above-mentioned digestive tract stent can include different sizes according to the physical condition of the patient and the placement position, for example, the size of the stent used for children is appropriately reduced compared to adults. Among them, the cross-sectional diameter of the stent body 10 is 5mm to 30mm, preferably 10mm to 20mm, and / or the axial length of the stent body 10 is 5mm to 100mm, preferably 10mm to 20mm. In actual application, a stent body 10 with a cross-sectional diameter slightly larger than or equal to the inner diameter size of the digestive tract should be selected to fit or support on the inner wall of the digestive tract.

[0056] Preferably, at least one anti-dislodging structure is formed on the outer circumferential surface of the stent body 10 of the digestive tract stent, so as to enhance the supporting and fixing relationship between the stent body 10 and the inner wall of the digestive tract, and further obtain the effect of anti-dislodging. The anti-dislodging structure protrudes from the outer circumferential surface of the stent body 10, as shown in the drawings, and can be an enlarged structure on the shape of the stent body 10 itself, or the anti-dislodging structure can include one or a combination of the following modes: at least one protruding portion 11 protruding radially outward from the outer circumferential surface of the stent body 10; and / or a granular or corrugated rough surface formed on the outer circumferential surface of the stent body 10. Figure 7

[0057] The fixing mechanism 20 of the digestive tract stent can have various different structural forms. For example, it can be a fixing member directly provided or connected to one end or both ends of the stent body 10 through a connecting structure. Preferably, as shown in Figure 1 、 Figure 2 、 Figure 3 、 Figure 4 、 Figure 6 、 Figure 7 、 Figure 8 and Figure 10 indicate that the fixing mechanism 20 includes a first fixing member 21 provided at the end edge of the stent body 10 and protruding radially outward, for forming a fixed fit with the digestive tract wall S. The fixing mechanism 20 can further include a connecting rod 22 (which can or can not have this structure), the connecting rod 22 extending from one end of the stent body, and the first fixing member 21 being mounted at the end of the connecting rod, for providing support to the stent body 10 through the connecting rod 22 when the first fixing member 21 forms a fixed fit with the digestive tract wall S, so that according to the length of the connecting rod 22, the fixing mechanism 20 can be further away from the action area of the stent body 10, which is beneficial for the surgeon to perform the operation and reduces the difficulty of the operation. The length of the connecting rod 22 is fixed; or the length of the connecting rod 22 is preferably adjustable, for example, the connecting rod 22 can be selected according to the actual situation of the patient before the operation, and then the installation (such as bonding, suturing, etc.) of the connecting rod 22 with the stent body 10 and / or the first fixing member 21 is completed before the stent placement operation is performed.

[0058] Among them, the connecting rod 22 can extend in the axial direction of the stent body 10; or the extension direction of the connecting rod 22 can deviate from the axial direction, so that the first fixing member 21 is away from the stent body 10 in the radial direction of the stent body 10. According to different operation environments, the first fixing member 21 can include one or more of the following structural forms: a hooking structure as shown in Figure 4 and Figure 5 , which is used to support on the digestive tract wall S, so as to hook on the wrinkles on the surface of the digestive tract wall S; a Figure 2 、 Figure 3 and Figure 13 ​The mounting seat is used to be fixed with a thumbtack, rivet, screw or button which penetrates the digestive tract wall S from outside the esophagus; the thumbtack, rivet, screw or button, etc. Figure 6 The screw or button, etc. (in the above-mentioned workpiece form, the end pointing to the digestive tract wall S in the stent placement state is preferably wedge-shaped or conical) is used to penetrate the digestive tract wall S and be fixed outside the digestive tract wall S through the corresponding mounting seat; and the suture hole is used to suture the fixing mechanism 20 to the digestive tract wall S through a suture.

[0059] According to any of the above-mentioned embodiments, the digestive tract stent is preferably matched with an external binding member to bind the digestive tract wall S to the stent body on the outer surface of the digestive tract for reinforcement. The external binding member can include an elastic or non-elastic binding rope or belt 23. As shown in Figure 11 , Figure 12 and Figure 13 When the stent body 10 supports the digestive tract wall S in the digestive tract, the belt 23 covers or wraps around the outer surface of the digestive tract wall S, thereby forming a protective layer on the outer surface of the digestive tract wall S. The binding rope or belt 23 used as the external binding member can be made of a non-degradable material, or preferably a biocompatible fully degradable material. The degradation period of the degradable external binding member is preferably greater than or equal to the degradation period of the degradable digestive tract stent.

[0060] The belt 23 can be only sleeved on the digestive tract, or can also be fixed in cooperation with the first fixing member 21 of the fixing mechanism 20. As shown in Figure 11 The belt 23 preferably includes a flexible surface 24 and a second fixing end 25 provided on the flexible surface 24, which penetrates the digestive tract wall S with one of the first fixing members 21 and is fixed with the other. Among them, one of the first fixing member 21 and the second fixing end 25 is preferably the mounting seat described above, and the other is a thumbtack, rivet, screw or button fixing member matched with the mounting seat. In order to facilitate penetration of the digestive tract wall S, the mounting end of the above-mentioned thumbtack, rivet, screw or button fixing member is preferably wedge-shaped or conical.

[0061] The digestive tract stent preferably also has an anti-reflux function, especially for preventing food or gastric acid reflux when applied to the esophagus, thereby improving the prognosis and quality of life of patients. The stent body 10 of the digestive tract stent preferably has an anti-reflux mechanism 13, as shown in Figure 10 and Figure 14As shown, the anti-reflux mechanism 13 is configured to allow the flow of fluid or solid in the stent body 10 in the first axial direction D1 and to prevent or reduce the flow of fluid or solid in the stent body 10 in the second axial direction D2, thereby achieving the anti-reflux effect. The anti-reflux mechanism 13 can be made of the same or different material as the stent body 10, bonded or sewn to the stent body 10, or integrally formed with the stent body 10.

[0062] The anti-reflux mechanism 13 can specifically be a slope structure or a film structure inclined in the stent body 10 in the first axial direction D1 to provide a certain degree of flow guiding effect. Preferably, as shown in Figure 8 、 Figure 9 and Figure 10 The anti-reflux mechanism 13 includes at least one flexible flow guide 131 fixed to the inner circumferential surface of the stent body 10. When the patient swallows food, the food overcomes the resistance of the flexible flow guide 131 to pass through the stent. When the food refluxes, the flexible flow guide 131 can also play a certain degree of resistance. The flexible flow guide 131 can be arranged perpendicular to the digestive tract wall, or preferably extended or curvedly extended towards the first axial direction D1.

[0063] In the case where the anti-reflux mechanism 13 includes a plurality of flexible flow guides 131, the plurality of flexible flow guides 131 can be distributed as follows: a plurality of flexible flow guides 131 are distributed on different cross sections in the axial direction of the digestive tract wall S to achieve multi-stage anti-reflux and improve the reliability of anti-reflux; and / or a plurality of flexible flow guides 131 are distributed on the same cross section in the axial direction of the digestive tract wall S to be able to share the anti-reflux pressure of the flexible flow guide 131. Preferably, between the flexible flow guides 131 distributed on the same cross section in the axial direction of the digestive tract wall S, there are flow guiding openings, which can include the following two states: when fluid or solid moves in the first axial direction D1, the plurality of flexible flow guides 131 are deformed towards the first axial direction D1 under the pushing of the fluid or solid, and the flow guiding openings are opened; and when there is no fluid or solid passing through, or when fluid or solid moves in the second axial direction D2, the flexible flow guide 131 restores its shape under the action of its own elastic force, and the flow guiding opening is closed to prevent or reduce the reflux of food or gastric acid.

[0064] According to the preferred embodiment of the present application, the stent body 10 of the digestive tract stent is supported on the inner wall of the digestive tract after being deployed in the digestive tract, and the stent body is further fixed to the wall of the digestive tract by the fixing mechanism 20 fixed to both ends of the stent body 10 in the axial direction and the sleeve belt 23 cooperating with the first fixing member 21 outside the wall S of the digestive tract, so that the position of the stent body in the digestive tract is more stable, and the reliability of the digestive tract stent is improved. The digestive tract stent and the sleeve belt 23 as the external restraint member are both made of degradable material, which can degrade automatically after the degradation period, reducing complications. And the anti-reflux mechanism 13 in the stent body 10 can reduce the reflux of food or gastric acid, and improve the prognosis of the patient's quality of life. Therefore, the digestive tract stent according to the present application provides a more reliable treatment for patients with esophageal cancer, especially for patients with anastomosis-related complications.

[0065] According to the different surgical procedures, the placement of the digestive tract stent according to the present application can include but is not limited to the following methods:

[0066] Digestive tract surgery: taking esophageal cancer surgery as an example, the esophagus is fully freed in the thoracic cavity, the proximal end is 5-10 cm above the upper edge of the tumor (head side), and the distal end is the junction of the esophagus and the stomach (cardia). At 5-10 cm above the upper edge of the tumor (head side), the esophagus is cut, and the digestive tract stent is placed into the esophageal lumen through the proximal end of the esophagus, preferably the first fixing member 21 pierces the digestive tract wall, and the stent is suspended on the digestive tract wall and fixed in the digestive tract lumen. The stomach is fully freed in the abdominal cavity (the right gastroomental blood vessel and the vascular arch are reserved), and proximal subtotal gastrectomy (1 / 3-2 / 3 of the stomach body is removed) is performed on the lesser curvature of the stomach by using a linear cutting stapler. The stomach is cut into a tubular structure similar to the esophagus. The top end of the tubular stomach is cut (or the top end of the tubular stomach is cut off), and the distal end of the digestive tract stent is placed into the stomach cavity through the incision, preferably the first fixing member 21 pierces the digestive tract wall, and the stent is suspended on the digestive tract wall and fixed in the digestive tract lumen. As shown in FIG. Figure 14 The proximal end of the esophagus and the tubular stomach are fully sutured to the stent body 10 or the outer surface thereof (when suturing, the esophageal stump, the tubular stomach, and the stent body 10 can also be sutured together). Then, the second fixing end 25 in the sleeve belt 23 is installed and fixed with the first fixing member 21 on the outer surface of the digestive tract wall. After this operation, the esophagus and stomach anastomosis has the digestive tract stent as the inner support, and the sleeve belt 23 as the protective film on the outer surface, which is a three-layer structure, equivalent to triple insurance. On the one hand, it can significantly reduce the incidence of anastomotic fistula, and on the other hand, the digestive tract stent as the inner support can also significantly reduce the incidence of anastomotic stenosis. The anti-reflux structure of the digestive tract stent can also significantly reduce the incidence of gastroesophageal reflux.

[0067] Interventional hybrid surgery (interventional surgery + thoracoscopy / laparoscopy surgery): under the perspective, a thin metal guide wire is placed into the esophagus through the oral cavity, and is guided to the distal end (caudal side) of the lesion (perforation / narrow) along the esophageal lumen. The stent is sent to the lesion site guided by the guide wire. Under the thoracoscope / laparoscope, the outer surface of the digestive tract wall is observed in the thoracic cavity / abdominal cavity, and the stent is released and fixed by the fixing mechanism 20 under direct vision.

[0068] Endoscopic hybrid surgery (gastroscope / enteroscope surgery + thoracoscopy / laparoscopy surgery): the gastroscope is placed into the esophagus / stomach / duodenum through the oral cavity, or the enteroscope is placed into the rectum / colon through the anus, and is guided to the lesion (perforation / narrow) along the digestive tract. The digestive tract stent is sent to the lesion site by the endoscope. Under the thoracoscope / laparoscope, the outer surface of the digestive tract wall is observed in the thoracic cavity / abdominal cavity, and the stent is released and fixed by the fixing mechanism 20 under direct vision.

[0069] The preferred embodiments of the present application are described in detail above, but the present application is not limited to the specific details in the above-described embodiments. Within the technical concept of the present application, the specific embodiments of the digestive tract stent or simple modifications of the technical solutions of the present application can be determined according to the actual condition of the patient and the selection of the surgical procedure, and these simple modifications all belong to the protection scope of the present application.

[0070] In addition, it should be noted that each specific technical feature described in the above-described specific embodiments can be combined in any appropriate manner without contradiction. In order to avoid unnecessary repetition, the present application will not further describe various possible combinations.

[0071] Furthermore, various different embodiments of the present application can also be combined in any appropriate manner, as long as it does not deviate from the idea of the present application, and it should be considered as disclosed in the present application.

Claims

1. A gastrointestinal stent, comprising: a stent body (10) which is a hollow tubular member; and a fixing mechanism (20) fixed to at least one end of the stent body (10) in an axial direction and protruding from an outer circumferential surface of the stent body (10) in a radial direction of the stent body (10); wherein the fixing mechanism (20) comprises a first fixing member (21) and a connecting rod (22) extending from one end of the stent body (10) away from the stent body in the axial direction, and the first fixing member (21) is mounted to a distal end of the connecting rod (22) and protrudes radially outwardly; the length of the connecting rod (22) is adjustable; a corresponding length of the connecting rod (22) is selected according to the actual condition of the patient before the operation, and the stent is implanted after the connecting rod (22) is installed on site with the stent body (10) and / or the first fixing member (21); the gastrointestinal stent cooperates with an external binding member for binding the gastrointestinal wall (S) to the stent body on the external surface of the gastrointestinal tract; the external binding member comprises a sleeve belt (23), and the sleeve belt (23) is wrapped or wound on the external surface of the gastrointestinal wall (S) when the stent body (10) supports the gastrointestinal wall (S) inside the gastrointestinal tract; the gastrointestinal stent and the sleeve belt (23) are both made of degradable material, the degradation period of the sleeve belt (23) is greater than or equal to the degradation period of the stent body (10) and the fixing mechanism (20), and the sleeve belt (23) comprises a flexible surface (24) and a second fixing end (25) provided on the flexible surface (24), and the second fixing end (25) penetrates the gastrointestinal wall (S) and is fixed with one of the first fixing members (21).

2. The digestive tract stent of claim 1, wherein, The surface of the stent body (10) and / or the fixing mechanism (20) is coated with a film, and the film comprises a drug loading layer.

3. The digestive tract stent of claim 2, wherein, The drug loading layer comprises one or more of the following drugs: sirolimus, glucocorticoid, mitomycin, paclitaxel, paclitaxel derivative, dactinomycin, 5-fluorouracil, rapamycin.

4. The gastrointestinal stent according to claim 1, wherein: the stent body (10) is a mesh structure or a spiral structure.

5. The digestive tract stent of claim 1, wherein, The cross-sectional diameter of the stent body (10) is 5mm to 30mm, and / or the axial length of the stent body (10) is 5mm to 100mm.

6. The digestive tract stent of claim 1, wherein, At least one anti-dislodging structure is formed on the outer circumferential surface of the stent body (10) and protrudes from the outer circumferential surface of the stent body (10).

7. The digestive tract stent of claim 1, wherein A plurality of fixing mechanisms (20) are arranged at both ends of the stent body (10) in the axial direction, and the plurality of fixing mechanisms (20) are uniformly or non-uniformly distributed around the circumferential direction of the stent body (10).

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