Minimally invasive degradable alimentary canal anastomosis stent through natural orifice and implantation method of minimally invasive degradable alimentary canal anastomosis stent

Abstract

The invention discloses a minimally invasive degradable digestive tract anastomosis stent through a natural orifice, which comprises a stent main body, the stent main body has compressibility, is a balloon expansible or self-expandable stent, is made of a degradable material, is small in the middle and relatively expanded at two ends, and is provided with a plurality of barbs at two ends. When the support body is compressed, the barbs can be attached to the outer wall of the support body, and when the support body is unfolded, the barbs can be unfolded towards the outer side. The barb structures are arranged at the two ends of the stent body, the stent body can be fixed more firmly after the balloon is expanded, it can be ensured that an anastomotic stoma can be kept stable after an operation, and the risk of fistula formation is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity and an implantation method thereof. Background Art

[0002] Digestive tract reconstruction after surgical resection of the digestive tract is the key to surgical operations. The anastomosis operation is prone to be complicated and traumatic, or complications may occur after anastomosis, such as anastomotic leakage and anastomotic stenosis. The following introduces the technical background using the most common esophagogastric anastomosis as an example.

[0003] Esophageal cancer is one of the five malignant tumors with the highest incidence and mortality in China. Surgical resection is the preferred treatment method and the only radical cure. Esophageal-gastric anastomosis after surgical resection is the key to the operation. In open-chest surgery, the anastomosis techniques mainly include manual suture anastomosis and stapler anastomosis. Manual suture anastomosis is a traditional anastomosis method, which is completed by manual suture with silk thread or absorbable thread. The operation is complicated, the anastomosis takes a long time, and there are many complications. It is easy to have problems such as anastomotic fistula and stenosis. However, this method is low in cost and is still the main anastomosis method in some areas. There are currently two main methods of stapler anastomosis: circular stapler and linear stapler. Among them, the circular stapler is the most commonly used method. The method is mature, but the operation is relatively complicated. About 3%-5% of patients also have complications such as anastomotic fistula or stenosis.

[0004] Chinese patent CN209863936U discloses an anti-reflux digestive tract anastomosis stent used under laparoscopy, which is easy to slip off, posing a risk to patients. Summary of the invention

[0005] In view of the above problems existing in the existing stents, the present invention aims to provide a minimally invasive, degradable digestive tract anastomosis stent through the natural cavity with high stability, high safety and wide applicability, and an implantation method thereof.

[0006] The specific technical solutions are as follows:

[0007] A minimally invasive and degradable digestive tract anastomosis stent through a natural cavity comprises a stent body, the stent body is compressible, is a balloon-expandable or self-expanding stent, and is made of a degradable material. The stent body is small in the middle and relatively enlarged at both ends. The characteristic is that both ends of the stent body have a plurality of barbs. When the stent body is compressed, the barbs can be attached to the outer wall of the stent body. When the stent body is expanded, the barbs can extend outward.

[0008] As a further improvement and optimization of the present solution, the stent body includes a first braided mesh and a second braided mesh, the first braided mesh and the second braided mesh are cross-woven and connected, and the first braided mesh is extended at both ends of the stent body to form the barbs.

[0009] As a further improvement and optimization of the present solution, the first woven mesh is a single-layer woven mesh, and the second woven mesh is a double-layer woven mesh.

[0010] As a further improvement and optimization of the present solution, the extended threads of the first woven mesh are rotated in a single direction to form the barbs.

[0011] As a further improvement and optimization of the present solution, the extended silk threads of the first braided mesh are folded back at the ends to form the barbs.

[0012] As a further improvement and optimization of the present solution, the material of the stent body is a degradable zinc alloy, magnesium alloy or polylactic acid, polyethylene, PGA, or PCL material.

[0013] As a further improvement and optimization of this solution, the surface of the stent body can be coated with a biomaterial and can be coated with a sustained-release drug that stimulates tissue growth or resists infection.

[0014] As a further improvement and optimization of this solution, the stent also includes a delivery system and a guide wire, and the delivery system includes an inflation port, a three-layer pipeline, and a first balloon; the innermost layer of the three-layer pipeline is an inner core, the middle layer is a push tube, and the outermost layer is an outer sheath tube;

[0015] A guide wire can pass through the interior of the inner core, and the inflation port is arranged at the tail end of the inner core; the first balloon is arranged at the head end of the inner core, and the shape of the first balloon is set to correspond to the shape of the stent body; the stent body can be folded and compressed and attached to the outside of the first balloon inside the outer sheath and the head end of the inner core; after the delivery system delivers the stent body into place, the stent body is gradually pushed out and the first balloon is gradually expanded, so that the stent body can be gradually unfolded and fixed to anastomose the proximal and distal ends of the digestive tract, or air is injected through the inflation port to expand the first balloon, thereby assisting or promoting the expansion and fixation of the stent body.

[0016] As a further improvement and optimization of this solution, a detection mechanism is provided on the push tube to detect the tightness of the suture of the anastomosis, and the detection mechanism includes:

[0017] A second balloon and a third balloon, wherein the second balloon and the third balloon are sleeved and connected to the head of the push tube and are arranged at intervals, and the second balloon and the third balloon can be folded and compressed to be attached between the outer sheath tube and the push tube;

[0018] Among them, the outer wall of the tail of the push tube is circumferentially distributed with a first gas injection port, a liquid injection port and a second gas injection port, the outer wall of the head of the push tube has a first gas outlet connected to the second balloon, a second gas outlet connected to the third balloon, and a liquid outlet, the liquid outlet is arranged between the second balloon and the third balloon, and the inner wall of the push tube also has a first gas channel connecting the first gas injection port and the first gas outlet, a second gas channel connecting the second gas injection port and the second gas outlet, and a liquid injection channel connecting the liquid injection port and the liquid outlet.

[0019] An implantation method, comprising the above-mentioned minimally invasive and degradable digestive tract anastomosis stent through a natural cavity, the implantation method comprising:

[0020] S1: delivering the stent body to the front side of the anastomosis of the digestive tract through the delivery system;

[0021] S2: gradually pushing the inner core forward and pushing the stent body to the digestive tract anastomosis;

[0022] S3: injecting air into the inflation port to gradually expand the first balloon and assist the stent body to gradually unfold and fix, and anastomose the proximal and distal ends of the digestive tract;

[0023] S4: deflating the first balloon through the inflation port to shrink the first balloon, and pulling back the inner core until the first balloon shrinks into the push tube;

[0024] S5: pushing the pushing tube and the inner core forward step by step and synchronously, and pushing the third balloon and the second balloon in the detection mechanism out of the outer sheath tube in sequence, until the third balloon passes through the stent body;

[0025] S6: injecting gas into the second balloon and the third balloon through the first gas injection port and the second gas injection port respectively, so that the second balloon and the third balloon gradually expand until they are in sealing contact with the inner wall of the digestive tract;

[0026] S7: injecting a colored harmless liquid into the digestive tract between the second balloon and the third balloon through the liquid injection port, and determining whether liquid leaks out of the digestive tract through the anastomosis to detect the tightness of the anastomosis suture;

[0027] S8: When no leakage is detected, the second balloon and the third balloon are deflated and contracted, and the push tube and the inner core are gradually pulled back until the second balloon and the third balloon are sequentially contracted into the outer sheath tube;

[0028] S9: Take out the entire delivery system and complete the implantation operation of the stent body.

[0029] Compared with the prior art, the above technical solution has the following positive effects:

[0030] (1) The present invention provides a barb structure at both ends of the stent body, which can make the stent body more firmly fixed after balloon expansion, ensure that the anastomosis can remain stable after surgery, and reduce the risk of fistula formation.

[0031] (2) The design of the stent body of the present invention includes the functions of expansion and support to prevent the occurrence of stenosis at the anastomotic site. The stent is also adjustable to adapt to the anatomical structure and needs of different patients.

[0032] (3) The stent design of the present invention should be convenient for doctors to install and fix quickly and accurately during surgery.

[0033] (4) The present invention can reduce the time of anastomosis surgery through the design of the improved stent, thereby reducing the risks associated with anesthesia and surgery.

[0034] (5) The stent of the present invention is entirely covered with a film of medical material, which may be coated with drugs and biological factors, and may be slowly released, thereby facilitating anastomotic healing, supporting digestive function, and ensuring normal food passage.

[0035] (6) In this embodiment, after the stent body is installed, the tightness of the suture of the anastomosis can be detected by the detection mechanism to further avoid the occurrence of anastomotic leakage. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 It is a structural schematic diagram of a stent body of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention;

[0037] Figure 2 It is a schematic structural diagram of a stent body of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention;

[0038] Figure 3 This is a schematic diagram of the bag-shaped anti-reflux valve structure of a stent body of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention;

[0039] Figure 4 It is a schematic diagram of the structure of a stent body of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity in the digestive tract of the present invention;

[0040] Figure 5 It is a structural schematic diagram of a delivery system of a stent body of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention;

[0041] Figure 6It is a schematic structural diagram of a balloon-inflated and expanded stent body of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention;

[0042] Figure 7 It is a structural schematic diagram of a detection mechanism of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity of the present invention;

[0043] Figure 8 It is a structural schematic diagram of a detection mechanism of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity of the present invention;

[0044] Fig. 9 It is a cross-sectional view of a push tube of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention;

[0045] Fig.10 It is a cross-sectional view of a push tube of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention;

[0046] Fig.11 It is a structural schematic diagram of an annular groove of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention;

[0047] Fig.12 This is a cross-sectional view of the tail of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention;

[0048] Fig.13 It is a structural schematic diagram of a positioning mechanism of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity of the present invention;

[0049] In the accompanying drawings: 1. stent body; 2. delivery system; 3. guide wire; 11. barb; 12. bag-shaped anti-reflux valve; 21. inflation port; 22. inner core; 23. push tube; 24. outer sheath; 25. first balloon; 26. detection mechanism; 230. annular groove; 231. liquid outlet; 232. liquid injection port; 233. liquid injection channel; 234. first gas outlet; 235. first gas injection port; 236. first gas channel; 237. second gas outlet; 238. second gas injection port; 239. second gas channel; 261. second balloon; 262. third balloon; 263. adjustment ring; 264. nozzle; 265. positioning mechanism; 2651. positioning member; 2652. spring. DETAILED DESCRIPTION

[0050] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0051] In the description of the present invention, it should be noted that, if the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. appear, the orientation or position relationship indicated is based on the orientation or position relationship shown in the drawings, which is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, if the terms "first", "second", "third" appear, they are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0052] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0053] Figure 1 This is a schematic structural diagram of a stent body of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention. Figure 2 This is a schematic structural diagram of a stent body of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention. Figure 3 This is a schematic diagram of the bag-shaped anti-reflux valve structure of the stent body of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention. Figure 4 This is a schematic diagram of the structure of a stent body of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity in the digestive tract of the present invention. Figure 5 This is a schematic structural diagram of a delivery system for a stent body of a minimally invasive, degradable digestive tract anastomosis stent through a natural cavity according to the present invention. Figure 6 This is a schematic diagram of the structure of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity, wherein the stent body is inflated with a balloon and expanded. Figure 7 It is a structural schematic diagram of a detection mechanism of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity of the present invention; Figure 8 It is a structural schematic diagram of a detection mechanism of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity of the present invention; Fig. 9 It is a cross-sectional view of a push tube of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention; Fig.10 It is a cross-sectional view of a push tube of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention; Fig.11 It is a structural schematic diagram of an annular groove of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention; Fig.12FIG. 1 is a cross-sectional view of the tail of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity according to the present invention; Figure 1-6 As shown, a preferred embodiment of a minimally invasive and degradable digestive tract anastomosis stent through a natural cavity is shown, including a stent body 1. The stent body 1 is compressible, is a balloon-expandable or self-expanding stent, and is made of a degradable material. The stent body 1 is small in the middle and relatively enlarged at both ends. Both ends of the stent body 1 have a plurality of barbs 11. When the stent body 1 is compressed, the barbs 11 can be attached to the outer wall of the stent body 1. When the stent body 1 is expanded, the barbs 11 can extend outward.

[0054] In this embodiment, barb structures are provided at both ends of the stent body 1, which can make the stent body 1 more firmly fixed after the first balloon 25 is expanded, thereby ensuring that the anastomosis can remain stable after surgery and reducing the risk of fistula formation.

[0055] The design of the stent body 1 in this embodiment includes the functions of expansion and support to prevent the occurrence of stenosis at the anastomotic site. The stent is also adjustable to adapt to the anatomical structures and needs of different patients.

[0056] More preferably, the plurality of barbs 11 may be located on different planes of the stent body 1 .

[0057] Further, as a preferred embodiment, the stent body 1 includes a first braided mesh and a second braided mesh, the first braided mesh and the second braided mesh are cross-woven and connected, and the first braided mesh is extended at both ends of the stent body 1 to form barbs 11.

[0058] Furthermore, as a preferred embodiment, the first woven mesh is a single-layer woven mesh, and the second woven mesh is a double-layer woven mesh.

[0059] like Figure 1 As shown, the extended wires of the first braided mesh are rotated in a single direction to form barbs 11 .

[0060] like Figure 2 As shown in another preferred embodiment, the extended silk threads of the first braided mesh are folded back at the ends to form barbs 11.

[0061] Furthermore, as a preferred embodiment, the material of the stent body 1 is a degradable zinc alloy, magnesium alloy or polylactic acid, polyethylene, PGA, PCL material.

[0062] Furthermore, as a preferred embodiment, the surface of the stent body 1 may be coated with a biomaterial and may be coated with a sustained-release drug that stimulates tissue growth or resists infection.

[0063] Furthermore, as a preferred embodiment, a bag-shaped anti-reflux valve 12 is provided in the middle portion of the stent body 1, which is composed of 2-3 leaflets and is open in one direction.

[0064] Further, as a preferred embodiment, the stent further includes a delivery system 2 and a guide wire 3, wherein the delivery system 2 includes an inflation port 21, a three-layer pipeline, and a first balloon 25; the innermost layer of the three-layer pipeline is an inner core 22, the middle layer is a push tube 23, and the outermost layer is an outer sheath 24;

[0065] A guide wire 3 can pass through the interior of the inner core 22, and an inflation port 21 is provided at the tail end of the inner core 22; a first balloon 25 is provided at the head end of the inner core 22, and a shape of the first balloon 25 is provided to correspond to a shape of the stent body 1; the stent body 1 can be folded up and compressed and attached to the outer sheath 24 and the outside of the first balloon 25 at the head end of the inner core 22. After the delivery system 2 delivers the stent body 1 into place, the stent body 1 is gradually pushed out, and the first balloon 25 is gradually expanded, so that the stent body can be gradually unfolded and fixed to anastomose the proximal and distal ends of the digestive tract, or air is injected through the inflation port 21 to expand the first balloon 25, thereby assisting or promoting the expansion and fixation of the stent body 1.

[0066] Furthermore, as a preferred embodiment, one end of the guide wire 3 is a hard head and the other end is a soft head. When the delivery device enters through a natural cavity (such as the mouth, anus, etc.), the soft head is first inserted for guidance. When the position is reached and puncture is required (such as the blind end of the esophagus, stomach, etc.), the hard head is inserted to puncture the wall of the digestive tract and guide the delivery device.

[0067] In this embodiment, the bracket is designed to facilitate doctors to quickly and accurately install and fix it during surgery.

[0068] In this embodiment, the design of the improved stent can reduce the time of the anastomosis operation, thereby reducing the risks associated with anesthesia and surgery.

[0069] In this embodiment, the stent is entirely covered with a film of medical material, which may be covered with drugs and biological factors, and can be slowly released, which is beneficial to the healing of the anastomosis, supports the digestive function, and ensures the normal passage of food.

[0070] like Figure 7-13 As shown, the push tube 23 is provided with a detection mechanism 26 for detecting the tightness of the suture of the anastomosis, and the detection mechanism 26 includes:

[0071] A second balloon 261 and a third balloon 262, wherein the second balloon 261 and the third balloon 262 are sleeved and connected to the head of the push tube 23 and are arranged at intervals, and the second balloon 261 and the third balloon 262 can be retracted and compressed to be attached between the outer sheath tube 24 and the push tube 23;

[0072] Among them, the outer wall of the tail of the push tube 23 is circumferentially distributed with a first gas injection port 235, a liquid injection port 232 and a second gas injection port 238, the outer wall of the head of the push tube 23 has a first gas outlet 234 connected to the second balloon 261, a second gas outlet 237 connected to the third balloon 262, and a liquid outlet 231, the liquid outlet 231 is arranged between the second balloon 261 and the third balloon 262, and the inner wall of the push tube 23 also has a first gas channel 236 connecting the first gas injection port 235 and the first gas outlet 234, a second gas channel 239 connecting the second gas injection port 238 and the second gas outlet 237, and a liquid injection channel 233 connecting the liquid injection port 232 and the liquid outlet 231.

[0073] In this embodiment, before and after the installation of the bracket body, the inner core and the push tube 23 can be pushed forward and pushed out by the outer sheath, so that the second balloon 261 and the third balloon 262 are respectively located on both sides of the anastomosis, and the second balloon 261 and the third balloon 262 are respectively injected with gas through the first gas injection port 235 and the second gas injection port 238, so that the second balloon 261 and the third balloon 262 expand outward until the second balloon 261 and the third balloon 262 are respectively in sealing contact with the inner wall of the digestive tract, and then harmless liquid (which can be colored harmless liquid) is injected into the digestive tract between the second balloon 261 and the third balloon 262 through the liquid injection port 232. By judging whether there is liquid leakage to the outside of the digestive tract through the anastomosis, the tightness of the anastomotic suture can be detected to further avoid the occurrence of anastomotic fistula.

[0074] Furthermore, an adjusting ring 263 is provided at the tail of the push tube 23, and the adjusting ring 263 is rotatably sleeved on the push tube 23, and the inner wall of the adjusting ring 263 is sealed with the outer wall of the push tube 23, and the adjusting ring 263 is provided with a nozzle 264 connected to the inner ring of the adjusting ring 263, and the adjusting ring 263 is rotated so that the nozzle 264 can be connected to the first gas injection port 235 / the second gas injection port 238 / the liquid injection port 232. In actual operation, the present embodiment is connected to the first gas injection port 235 by rotating the adjusting ring 263, and the air pump is connected to the nozzle 264 to inject gas into the first gas injection port 235 to expand the second balloon 261, and then the adjusting ring 263 is rotated so that the nozzle 264 is connected to the second The gas injection port 238 is connected, and gas is injected into the second gas injection port 238 to expand the third balloon 262, and the adjusting ring 263 is rotated again to connect the nozzle 264 with the liquid injection port 232, and the water pump is connected through the nozzle 264 to inject harmless liquid into the liquid injection port 232, so that the liquid outlet 231 discharges liquid outward. When the liquid injection reaches a predetermined amount, the adjusting ring 263 can be rotated again to stagger the nozzle 264 with the first gas injection port 235, the second gas injection port 238 and the liquid injection port 232, so that the inner wall of the adjusting ring 263 blocks the first gas injection port 235, the second gas injection port 238 and the liquid injection port 232, and then observe whether there is leakage at the anastomosis to determine the tightness of the suture of the anastomosis.

[0075] More preferably, the tail of the push tube 23 has an annular groove 230 , the first liquid injection port 232 , the second liquid injection port 232 and the liquid injection port 232 are all located at the bottom of the annular groove 230 , and the adjustment ring 263 is coaxially rotatably disposed in the annular groove 230 .

[0076] A positioning mechanism 265 is also provided between the adjusting ring 263 and the pushing tube 23, and the positioning mechanism 265 includes: a positioning piece 2651 elastically arranged on the side wall of the adjusting ring 263 and three hemispherical positioning grooves arranged on the side wall of the annular groove 230, the positions of the three positioning grooves are respectively arranged in a one-to-one correspondence with the first gas injection port 235, the second gas injection port 238, and the liquid injection port 232, and the positioning piece 2651 can be positioned and matched with any one of the positioning grooves, and the positioning piece 2651 is positioned and matched with a positioning groove so that the nozzle 264 can be stably connected with the first gas injection port 235 / the second gas injection port 238 / the liquid injection port 232. When the adjusting ring 263 is manually rotated, the positioning piece 2651 can be retracted into the side wall of the adjusting ring 263 and slide out of the corresponding positioning groove.

[0077] More preferably, a contraction groove is provided on the side wall of the adjustment ring 263, one end of the positioning member 2651 is slidably provided in the contraction groove, the other end of the positioning member 2651 is a hemispherical structure, and a spring 2652 is provided in the contraction groove, one end of the spring 2652 is against the bottom of the contraction groove, and the other end is against one end of the positioning member 2651.

[0078] More optimally, three markings are provided on the outer wall of the rear end of the push tube 23, and the three marking positions are arranged one by one corresponding to the first gas injection port 235, the second gas injection port 238, and the liquid injection port 232. The nozzle 264 is rotated to an marking position, and the positioning piece 2651 is positioned and matched with the positioning groove at the corresponding position.

[0079] An implantation method, comprising the above-mentioned minimally invasive degradable digestive tract anastomosis stent through natural cavity, the implantation method comprising:

[0080] S1: delivering the stent body 1 to the front side of the anastomosis of the digestive tract through the delivery system 2;

[0081] S2: gradually push the inner core 22 forward and push the stent body 1 to the digestive tract anastomosis;

[0082] S3: injecting air into the inflation port 21 to gradually expand the first balloon 25 and assist the stent body 1 to gradually unfold and fix, and anastomose the distal and proximal ends of the digestive tract;

[0083] S4: Deflate the first balloon 25 through the inflation port 21 to shrink the first balloon 25 and pull back the inner core 22 until the first balloon 25 shrinks into the push tube 23;

[0084] S5: Pushing the pushing tube 23 and the inner core 22 forward step by step and synchronously, and pushing the third balloon 262 and the second balloon 261 in the detection mechanism 26 out of the outer sheath tube 24 in sequence, until the third balloon 262 passes through the stent body 1;

[0085] S6: injecting gas into the second balloon 261 and the third balloon 262 through the first gas injection port 235 and the second gas injection port 238 respectively, so that the second balloon 261 and the third balloon 262 gradually expand until they are in sealing contact with the inner wall of the digestive tract;

[0086] S7: injecting a colored harmless liquid into the digestive tract between the second balloon 261 and the third balloon 262 through the liquid injection port 232, and determining whether liquid leaks out of the digestive tract through the anastomosis to detect the tightness of the anastomosis suture;

[0087] S8: When no leakage is detected, the second balloon 261 and the third balloon 262 are deflated and contracted, and the push tube 23 and the inner core 22 are gradually pulled back until the second balloon 261 and the third balloon 262 are successively contracted into the outer sheath tube 24;

[0088] S9: Take out the entire delivery system 2 and complete the implantation operation of the stent body 1.

[0089] The above description is only a preferred embodiment of the present invention, and does not limit the implementation mode and protection scope of the present invention. For those skilled in the art, it should be aware that all solutions obtained by equivalent substitutions and obvious changes made using the description and illustrations of the present invention should be included in the protection scope of the present invention.

Claims

1. A minimally invasive and degradable digestive tract anastomosis stent through a natural cavity, comprising a stent body, the stent body is compressible, is a balloon expandable or self-expandable stent, and is made of a degradable material, and the stent body is small in the middle and relatively expanded at both ends, characterized in that: Both ends of the stent body are provided with a plurality of barbs. When the stent body is compressed, the barbs can be attached to the outer wall of the stent body. When the stent body is expanded, the barbs can be extended outward.

2. The minimally invasive and degradable digestive tract anastomosis stent through natural cavity according to claim 1, characterized in that: The stent body comprises a first braided mesh and a second braided mesh, the first braided mesh and the second braided mesh are cross-woven and connected, and the first braided mesh is extended at both ends of the stent body to form the barbs.

3. The minimally invasive and degradable digestive tract anastomosis stent through natural cavity according to claim 2, characterized in that: The first woven mesh is a single-layer woven mesh, and the second woven mesh is a double-layer woven mesh.

4. The minimally invasive biodegradable digestive tract anastomosis stent through natural cavity according to any one of claims 2-3, characterized in that: The extended wires of the first braided mesh are rotated in a single direction to form the barbs.

5. The minimally invasive biodegradable digestive tract anastomosis stent through natural cavity according to any one of claims 2-3, characterized in that: The extended wires of the first braided mesh are folded back at the ends to form the barbs.

6. The minimally invasive and degradable digestive tract anastomosis stent through natural cavity according to claim 1, characterized in that: The material of the stent body is a degradable zinc alloy, magnesium alloy or polylactic acid, polyethylene, PGA, or PCL material.

7. The minimally invasive and degradable digestive tract anastomosis stent through natural cavity according to claim 1, characterized in that: The surface of the stent body may be coated with a biomaterial and may be coated with a sustained-release drug that stimulates tissue growth or resists infection.

8. The minimally invasive and degradable digestive tract anastomosis stent through natural cavity according to claim 1, characterized in that: The stent also includes a delivery system and a guide wire. The delivery system includes an inflation port, a three-layer pipeline, and a first balloon. The innermost layer of the three-layer pipeline is an inner core, the middle layer is a push tube, and the outermost layer is an outer sheath tube. A guide wire can pass through the interior of the inner core, and the inflation port is arranged at the tail end of the inner core; the first balloon is arranged at the head end of the inner core, and the shape of the first balloon is set to correspond to the shape of the stent body; the stent body can be folded and compressed and attached to the outside of the first balloon inside the outer sheath and the head end of the inner core; after the delivery system delivers the stent body into place, the stent body is gradually pushed out and the first balloon is gradually expanded, so that the stent body can be gradually unfolded and fixed to anastomose the proximal and distal ends of the digestive tract, or air is injected through the inflation port to expand the first balloon, thereby assisting or promoting the expansion and fixation of the stent body.

9. The minimally invasive and degradable digestive tract anastomosis stent through natural cavity according to claim 8, characterized in that: The push tube is provided with a detection mechanism for detecting the tightness of the suture of the anastomosis, and the detection mechanism comprises: A second balloon and a third balloon, wherein the second balloon and the third balloon are sleeved and connected to the head of the push tube and are arranged at intervals, and the second balloon and the third balloon can be folded and compressed to be attached between the outer sheath tube and the push tube; Among them, the outer wall of the tail of the push tube is circumferentially distributed with a first gas injection port, a liquid injection port and a second gas injection port, the outer wall of the head of the push tube has a first gas outlet connected to the second balloon, a second gas outlet connected to the third balloon, and a liquid outlet, the liquid outlet is arranged between the second balloon and the third balloon, and the inner wall of the push tube also has a first gas channel connecting the first gas injection port and the first gas outlet, a second gas channel connecting the second gas injection port and the second gas outlet, and a liquid injection channel connecting the liquid injection port and the liquid outlet.

10. An implantation method, comprising the minimally invasive and degradable digestive tract anastomosis stent through natural cavity as claimed in claim 9, characterized in that: The implantation method comprises: S1: delivering the stent body to the front side of the anastomosis of the digestive tract through the delivery system; S2: gradually pushing the inner core forward and pushing the stent body to the digestive tract anastomosis; S3: injecting air into the inflation port to gradually expand the first balloon and assist the stent body to gradually unfold and fix, and anastomose the proximal and distal ends of the digestive tract; S4: deflating the first balloon through the inflation port to shrink the first balloon, and pulling back the inner core until the first balloon shrinks into the push tube; S5: pushing the pushing tube and the inner core forward step by step and synchronously, and pushing the third balloon and the second balloon in the detection mechanism out of the outer sheath tube in sequence, until the third balloon passes through the stent body; S6: injecting gas into the second balloon and the third balloon through the first gas injection port and the second gas injection port respectively, so that the second balloon and the third balloon gradually expand until they are in sealing contact with the inner wall of the digestive tract; S7: injecting a colored harmless liquid into the digestive tract between the second balloon and the third balloon through the liquid injection port, and determining whether liquid leaks out of the digestive tract through the anastomosis to detect the tightness of the anastomosis suture; S8: When no leakage is detected, the second balloon and the third balloon are deflated and contracted, and the push tube and the inner core are gradually pulled back until the second balloon and the third balloon are sequentially contracted into the outer sheath tube; S9: Take out the entire delivery system and complete the implantation operation of the stent body.

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