CN113520704A

CN113520704A - Anastomotic stoma fistula-preventing device, sealed storage box and loader

Info

Publication number: CN113520704A
Application number: CN202110781818.1A
Authority: CN
Inventors: 陈坤; 崔毅杰; 张昱昕; 张霞
Original assignee: Lepu Medical Technology Beijing Co Ltd
Current assignee: Lepu Medical Technology Beijing Co Ltd
Priority date: 2021-07-09
Filing date: 2021-07-09
Publication date: 2021-10-22
Anticipated expiration: 2041-07-09
Also published as: CN113520704B

Abstract

The invention relates to the technical field of medical equipment, in particular to an anastomotic stoma fistula-preventing device, a sealed storage box and a loader. Anastomotic stoma fistula-preventing device, comprising: the stent braid is made of a fully degradable material and has a mesh structure with self-expansion performance so as to provide continuous circumferential support for the inner wall of the intestinal tract; the covering film is coated on the surface of the stent braid so as to coat meshes on the stent braid; and the coating is a fully degradable material. The stent braid is made of a fully degradable material with self-expansion performance, and a covering film used for covering the surface of the stent braid is also made of the fully degradable material. Thereby solve current large intestine fistula-preventing device and still need take back, improved the loaded down with trivial details degree of operation, increased the painful problem of disease simultaneously.

Description

Anastomotic stoma fistula-preventing device, sealed storage box and loader

Technical Field

The invention relates to the technical field of medical equipment, in particular to an anastomotic stoma fistula-preventing device, a sealed storage box and a loader.

Background

At present, in the field of anorectal surgery, the method for preventing large intestine fistula, except for full intestinal tract preparation before operation, for performing ileum or transverse colon ostomy is an effective and reliable method for preventing and treating large intestine anastomosis fistula recognized worldwide at present.

In the prior art, for example, patent document No. CN2875327Y discloses: a large intestine fistula-proof device. The large intestine fistula-preventing device can not be completely degraded after operation. Resulting in the large intestine fistula-preventing device also requiring the medical staff to perform the operation again to retrieve the large intestine fistula-preventing device. This not only improves the complexity of the operation, but also increases the pain of the patient. Therefore, there is a need for a stomal fistula-preventing device that can achieve complete degradation to solve the above problems.

Disclosure of Invention

The invention aims to solve the technical problem that the large intestine fistula-preventing device in the prior art can not realize full degradation, so that the large intestine fistula-preventing device needs to be taken back, thereby improving the complexity of the operation and increasing the pain of patients, and in order to solve the problem, the invention provides an anastomotic stoma fistula-preventing device, which comprises:

the stent braid is made of a fully degradable material and has a mesh structure with self-expansion performance so as to provide continuous circumferential support for the inner wall of the intestinal tract;

the covering film is coated on the surface of the stent braid so as to coat meshes on the stent braid; and the coating is a fully degradable material.

Optionally, the stent braiding body is formed by braiding and shaping a thread.

Optionally, the coating is a modified polymer material and is attached to the surface of the stent braid.

Optionally, the stent braiding body is a columnar structure with a diameter at the middle position smaller than diameters at two end positions; the middle position of the support braided body is a contraction part;

one end of the stent braid body is provided with an inlet reaming part used for fitting intestinal tract inner folds, and solid and/or liquid in the intestinal tract can enter the anastomotic stoma fistula-preventing device to protect intestinal tract wounds outside the contraction part;

the other end of the support braided body is an outlet reaming part for allowing solid and/or liquid entering the anastomotic stoma fistula-preventing device to flow out.

Optionally, the outer peripheral edge that the entrance reaming part is close to the opening position is provided with annular throat, annular throat orientation the entrance reaming part is kept away from the one end orientation of constriction part and is kept away from anastomotic stoma fistula prevention device central line direction and expands outward, and expands the angle outward and be 0 to 60 to the laminating intestinal.

Optionally, the maximum diameter of the inlet reamer part is 28mm to 40 mm; the diameter of the annular necking is 24mm to 36 mm.

Optionally, a degradable magnesium alloy nail-shaped barb is further arranged on one side of the annular necking, which faces the shrinking portion, so as to fix the anastomotic stoma fistula-preventing device; and/or the presence of a gas in the gas,

the coating at the annular throat location has a developer coating for X-ray development; and/or the presence of a gas in the gas,

and a metal developing ring is arranged at the central position of the contraction part and is used for X-ray development.

Optionally, the diameter of the outlet reamer part is 30mm to 50mm so as to be matched with the intestinal fold for fixation; and the axial length of the outlet reamer part is 20mm to 40mm so as to prevent seepage from flowing to the contraction part to contact with the wound.

Optionally, the outlet reaming portion is provided with an external reaming angle of 5 to 45 degrees towards one side far away from the contraction portion to fix the anastomotic stoma fistula-preventing device and make the discharged substances in the intestinal tract flow out.

Optionally, the covering film at a position of the outlet reamer part far away from the contraction part is provided with a developer coating for X-ray development; and/or the presence of a gas in the gas,

and a metal developing ring is arranged at one side of the outlet expanding hole part, which is far away from the contraction part, so as to be used for X-ray development.

Optionally, the diameter of the constriction is 20mm to 30 mm; and/or the presence of a gas in the gas,

the covering film at the position of the contraction part is a high-compliance film material so as to be tightly attached to intestinal tissues; and/or the presence of a gas in the gas,

the covering film at the position of the contraction part is made of waterproof and leakproof materials and can bear the pressure of at least 10 kPa;

the covering film at the position of the contraction part is provided with a drug-loaded coating which is slowly released in the degradation process so as to inhibit inflammatory infection at the wound.

Optionally, the stent braid is a partially crystallized high-biocompatibility shape memory degradable polymer, and the shape memory degradable polymer comprises: at least one of polydioxanone, polylactide-ethylene glycol copolymer, polyglycolide-lactide copolymer, poly-L-lactide-D-lactide copolymer, polylactide-caprolactone copolymer, and degradable polyurethane.

A sealed storage box is used for storing an anastomotic stoma fistula-preventing device, wherein the anastomotic fistula-preventing device is in a release state in the sealed storage box.

A loader for an anastomotic stoma fistula-preventing device is used for loading the anastomotic fistula-preventing device to an intestinal tract inner wall position;

the loader includes: the anastomosis fistula-preventing device is accommodated in the connecting pipe; a traction rope for loading the anastomotic stoma fistula-preventing device is arranged on the outlet reaming part;

the traction rope is used for drawing the anastomotic stoma fistula-preventing device, so that the anastomotic stoma fistula-preventing device is pressed and held to be loaded into the connecting pipe through the loading funnel.

The technical scheme of the invention has the following advantages:

1. the anastomotic stoma fistula-preventing device of the invention comprises: the stent braid is made of a fully degradable material and has a mesh structure with self-expansion performance so as to provide continuous circumferential support for the inner wall of the intestinal tract; the covering film is coated on the surface of the stent braid so as to coat meshes on the stent braid; and the coating is a fully degradable material.

In the embodiment, the stent braid is made of a fully degradable material with self-expansion performance, and the covering film for covering the surface of the stent braid is also made of the fully degradable material. Above-mentioned setting can realize that coincide mouthful fistula-preventing device can realize the complete degradation in the organism to solve current large intestine fistula-preventing device and still need take back, improved the loaded down with trivial details degree of operation, increased the painful problem of disease simultaneously. In addition, the coating film can be used as a drug coating carrier while achieving leakage prevention and seepage prevention.

2. The anastomotic stoma fistula-preventing device is characterized in that the stent braiding body is formed by braiding and shaping one thread. The support woven body formed by weaving and shaping the single thread has the advantages of stable shape and firm and reliable structure.

3. According to the anastomotic stoma fistula-preventing device, the coating film is made of modified high polymer materials and is attached to the surface of the stent braid through a dip-coating and pulling method. The stent braiding body and the film covering of the functional film material are integrally formed, and the fully-film-covered braiding forming device has the advantages of stable form and firm and reliable structure.

4. According to the anastomotic stoma fistula-preventing device, the stent braid is of a columnar structure, the diameter of the middle position of the stent braid is smaller than the diameters of the two end positions of the stent braid; the middle position of the support braided body is a contraction part; one end of the stent braid body is provided with an inlet reaming part used for fitting intestinal tract inner folds, and solid and/or liquid in the intestinal tract can enter the anastomotic stoma fistula-preventing device to protect intestinal tract wounds outside the contraction part; the other end of the support braided body is an outlet reaming part for allowing solid and/or liquid entering the anastomotic stoma fistula-preventing device to flow out.

The stent braid is of a columnar structure with the diameter of the middle position smaller than the diameters of the two end positions, the stent braid has self-expansion performance and can provide continuous circumferential support for the inner wall of an intestinal tract, and the film covering structure can prevent leakage and completely prevent flowing substances in the intestinal tract from contacting with an anastomotic wound and the internal environment, so that solid and/or liquid in the intestinal tract can enter the anastomotic stoma fistula-preventing device, and the solid and/or liquid entering the anastomotic stoma fistula-preventing device can be ensured to flow out of the other end of the anastomotic stoma fistula-preventing device.

5. According to the anastomotic stoma fistula-preventing device, the outer periphery of the inlet reaming part close to the opening is provided with the annular necking, one end, facing the inlet reaming part and away from the shrinking part, of the annular necking outwards expands towards the direction away from the center line of the anastomotic stoma fistula-preventing device, and the outwards expanding angle is 0-60 degrees so as to be attached to the intestinal tract.

Above-mentioned annular throat that is located import reaming portion outer peripheral edges and import reaming portion edge are towards keeping away from outer angle of expanding of anastomotic stoma fistula prevention device central line direction external expanding, can make import reaming portion laminating intestinal effectively, make things convenient for in the intestinal material flows into anastomotic stoma fistula prevention device.

6. According to the anastomotic stoma fistula-preventing device, one side of the annular necking, which faces the shrinking part, is also provided with a degradable magnesium alloy nail-shaped barb so as to fix the anastomotic stoma fistula-preventing device; and/or the coating at the annular throat position is provided with a developer coating for X-ray development; and/or a metal developing ring is arranged at the central position of the contraction part and is used for X-ray development.

In the invention, one side of the annular necking towards the contraction part is also provided with a degradable magnesium alloy nail-shaped barb. The nail-shaped barb of the degradable magnesium alloy not only can realize full degradation in a living body, but also can effectively limit and fix the anastomotic stoma fistula-preventing device. The coating film has a developer coating, and a metal developing ring is arranged at the central position of the contraction part, so that the developer coating and the metal developing ring can be effectively used for X-ray development to guide the position of the key part of the anastomotic stoma fistula-preventing device.

7. According to the anastomotic stoma fistula-preventing device, the diameter of the outlet dilating part is 30mm to 50mm so as to be matched with intestinal internal crease for fixation; and the axial length of the outlet reamer part is 20mm to 40mm so as to prevent seepage from flowing to the contraction part to contact with the wound.

In the present invention the axial length of the exit reamer part is 20mm to 40mm to reserve a sufficient distance to prevent upward liquid seepage. The liquid flowing through the stoma fistula-preventing device will partially seep into the micropores between the device and the intestine due to capillary action before endothelialization of the device. If the length of the exit reamer part is too short, exudate is liable to contact the anastomotic wound to cause problems of inflammation, infection, intestinal fistula and the like, so that a sufficient length needs to be reserved.

8. According to the anastomotic stoma fistula-preventing device, the coating film at the position, on one side, away from the contraction part, of the outlet reaming part is provided with a developer coating for X-ray development; and/or a metal developing ring is arranged at one side of the outlet expanding hole part far away from the contraction part for X-ray development.

Through the developer coating and/or the metal developing ring at the outlet reaming part, the X-ray developing device can be effectively used for X-ray development and guiding the position of the key part of the anastomotic stoma fistula prevention device.

9. According to the anastomotic stoma fistula-preventing device, the covering film at the position of the contraction part is a high-compliance film material so as to be tightly attached to intestinal tissues; and/or the covering film at the position of the contraction part is made of a waterproof and leakproof material and can bear the pressure of at least 10 kPa; the covering film at the position of the contraction part is provided with a drug-loaded coating which is slowly released in the degradation process so as to inhibit inflammatory infection at the wound.

10. The sealed storage box is used for storing the anastomotic stoma fistula-preventing device, and the anastomotic stoma fistula-preventing device is in a release state in the sealed storage box.

The sealed storage box can effectively store the anastomotic stoma fistula-preventing device in a sealed way so as to protect fully-degradable high polymer materials and metal materials. And because of the characteristics of the high polymer material, the device is not suitable for keeping a pressing and holding state for a long time, and the sealed storage box is in a release state when being stored with the anastomotic stoma fistula-preventing device, so that the permanent deformation caused by material creep and stress relaxation is weakened as much as possible.

11. The loader for the anastomotic stoma fistula-preventing device is used for loading the anastomotic stoma fistula-preventing device to the position of the inner wall of an intestinal tract; the loader includes: the anastomosis fistula-preventing device is accommodated in the connecting pipe; a traction rope for loading the anastomotic stoma fistula-preventing device is arranged on the outlet reaming part; the traction rope is used for drawing the anastomotic stoma fistula-preventing device, so that the anastomotic stoma fistula-preventing device is pressed and held to be loaded into the connecting pipe through the loading funnel.

The use method of the loader comprises the following steps: and penetrating a traction rope into the loading funnel and out of the connecting pipe so as to pull the anastomotic stoma fistula-preventing device through the traction rope, so that the anastomotic stoma fistula-preventing device passes through the loading funnel and is pressed and held to be loaded into the connecting pipe. The connecting pipe is nested with the conveying system, so that the device is placed into the conveying system, and the traction rope is cut off and taken away after the anastomotic stoma fistula-preventing device is loaded.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

Fig. 1 is a schematic perspective view of an anastomotic stoma fistula-preventing device provided by the invention;

fig. 2 is a schematic perspective view of an inlet reaming part of the anastomotic stoma fistula-preventing device provided by the invention;

fig. 3 is a schematic perspective view of an outlet reaming part of the anastomotic stoma fistula-preventing device provided by the invention;

fig. 4 is a schematic perspective view of the loader according to the present invention.

Description of reference numerals:

1-a stent braid; 2-a constriction; 3-an inlet reamer part; 4-an exit reamer part; 5-ring necking; 6-a loader; 7-connecting pipe; 8-loading the funnel; 9-a traction rope.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.

Example 1

An anastomotic stoma fistula-preventing device in this embodiment, as shown in fig. 1, includes:

the support weaving body 1 is made of a fully degradable material and is formed by weaving and shaping a thread. And has a self-expanding mesh structure to provide continuous circumferential support to the inner wall of the intestine. As shown in fig. 1, the stent braid 1 is a columnar structure with a diameter at the middle position smaller than diameters at two end positions; the middle position of the support braiding body 1 is a contraction part 2; as shown in fig. 2, one end of the stent braid 1 is an inlet reaming part 3 for fitting the intestinal tract inner folds, and the inlet reaming part 3 allows solids and liquids in the intestinal tract to enter the anastomotic stoma fistula-preventing device so as to protect intestinal tract wounds outside the contraction part 2; as shown in fig. 3, the other end of the stent braid 1 is an outlet reamer part 4 for allowing the solid and liquid entering the anastomotic fistula prevention device to flow out; in this embodiment, the stent braid 1 is a partially crystallized high biocompatible shape memory degradable polymer comprising: at least one of polydioxanone, polylactide-ethylene glycol copolymer, polylactide-lactide copolymer, poly-L-lactide-D-lactide copolymer, polylactide-caprolactone copolymer, and degradable polyurethane;

a covering film, which is coated on the surface of the stent braid 1 to coat meshes on the stent braid 1; and the coating is a fully degradable material. The coating in this embodiment is a modified polymer material and is attached to the surface of the stent graft 1. Above-mentioned setting can realize that coincide mouthful fistula-preventing device can realize the complete degradation in the organism to solve current large intestine fistula-preventing device and still need take back, improved the loaded down with trivial details degree of operation, increased the painful problem of disease simultaneously. In addition, the coating film can be used as a drug coating carrier while achieving leakage prevention and seepage prevention.

In the present embodiment, as shown in fig. 2, an annular reduced opening 5 is provided on the outer periphery of the inlet reamer part 3 near the opening position, the annular reduced opening 5 is outwardly expanded towards the direction of the central line of the anastomotic stoma fistula-preventing device away from one end of the inlet reamer part 3 away from the reduced part 2, and the outwardly expanded angle is 45 ° so as to fit the intestinal tract. The annular necking 5 positioned on the outer periphery of the inlet reaming part 3 and the outer reaming angle of the edge of the inlet reaming part 3, which is outward expanded towards the direction far away from the center line of the anastomotic stoma fistula-preventing device, can effectively enable the inlet reaming part 3 to be attached to the intestinal tract, and facilitates the substance in the intestinal tract to flow into the anastomotic fistula-preventing device. One side of the annular necking 5 facing the contraction part 2 is also provided with a degradable magnesium alloy nail-shaped barb so as to fix the anastomotic stoma fistula-preventing device; the film at the location of the annular constriction 5 is provided with a developer coating for X-ray development; the central position of the contraction part 2 is provided with a metal developing ring for X-ray development.

In this embodiment, as shown in fig. 3, the diameter of the outlet reamer part 4 is 30mm to fit the intestinal fold; and, the axial length of the outlet reamer part 4 is 20mm to prevent the exudate from flowing toward the constriction part 2 to contact the wound. And an outer expansion angle with an angle of 30 degrees is arranged on one side of the outlet expansion hole part 4 facing away from the contraction part 2 so as to fix the anastomotic stoma fistula-preventing device and enable discharged substances in the intestinal tract to flow out. The coating film at the position of the exit reamer part 4 away from the constricted part 2 has a developer coating for X-ray development; and a metal developing ring is arranged at one side of the outlet reaming part 4, which is far away from the contraction part 2, so as to be used for X-ray development. The covering film at the position of the contraction part 2 is a high-compliance film material so as to be tightly attached to intestinal tissues; the covering film at the position of the contraction part 2 is made of waterproof and leakproof material and can bear the pressure of at least 10 kPa; the covering film at the position of the contraction part 2 is provided with a drug-loaded coating which is slowly released in the degradation process so as to inhibit inflammatory infection at the wound.

Of course, this embodiment is to the annular necking 5 towards the one end of the entrance reaming portion 3 far away from the constriction portion 2 is expanded outward towards the direction of the center line of the anastomotic stoma fistula-preventing device far away from, and this angle of outward expansion is not specifically limited, in other embodiments, the outer peripheral edge of the entrance reaming portion 3 near the opening position is provided with the annular necking 5, the annular necking 5 towards the one end of the entrance reaming portion 3 far away from the constriction portion 2 is expanded outward towards the direction of the center line of the anastomotic fistula-preventing device far away from, and the angle of outward expansion is 20 ° to fit the intestinal tract.

Of course, the present embodiment is not limited to the specific angle set on the side of the exit reamer part 4 facing away from the constriction part 2, and in other embodiments, the side of the exit reamer part 4 facing away from the constriction part 2 is set with an external angle of 45 ° to fix the stoma fistula-preventing device and make the substances discharged from the intestinal tract flow out.

Of course, the present embodiment does not specifically limit the forming manner of the stent braid 1, and in other embodiments, the stent braid 1 is formed by weaving and shaping at least two threads.

Example 2

A sealed storage box is used for storing an anastomotic stoma fistula-preventing device, wherein the anastomotic fistula-preventing device is in a release state in the sealed storage box. The sealed storage box can effectively store the anastomotic stoma fistula-preventing device in a sealed manner so as to protect the fully-degradable high-molecular metal material. And the sealed storage box is in a release state when storing the anastomotic stoma fistula-preventing device and is used for avoiding material creep and stress relaxation caused by long-time holding.

Example 3

As shown in fig. 4, the loader 6 includes: the fistula-proof device comprises a connecting pipe 7 and a loading funnel 8 arranged at the end part of the connecting pipe 7, wherein the anastomosis fistula-proof device is accommodated in the connecting pipe 7; and a traction rope 9 for loading the anastomotic stoma fistula-preventing device is arranged on the outlet reaming part 4.

The use method of the loader 6 comprises the following steps: a pulling rope 9 is threaded in from the loading funnel 8 and out from the connecting tube 7, so that the anastomotic fistula-preventing device is pulled by the pulling rope 9, passes through the loading funnel 8, and is press-and-hold loaded into the connecting tube 7. The connecting pipe 7 is nested with the conveying system, so that the device is placed into the conveying system, and the traction rope 9 is cut off and taken away after the anastomotic stoma fistula-preventing device is loaded.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims

1. An anastomotic fistula prevention device, comprising:

the stent braid (1), the stent braid (1) is made of fully degradable material and has a net structure with self-expansion performance so as to provide continuous circumferential support for the inner wall of the intestinal tract;

the covering membrane is coated on the surface of the stent braid (1) so as to coat meshes on the stent braid (1); and the coating is a fully degradable material.

2. The anastomotic stoma fistula prevention device according to claim 1, wherein the stent braid (1) is formed by braiding and sizing one wire.

3. The anastomotic stoma fistula-preventing device according to claim 2, wherein the covering film is a modified polymer material and is attached to the surface of the stent braid (1).

4. The anastomotic stoma fistula prevention device according to claim 1, wherein the stent braid (1) is a columnar structure having a diameter at a middle position smaller than diameters at both end positions thereof; the middle position of the support braided body (1) is a contraction part (2);

one end of the stent braiding body (1) is provided with an inlet reaming part (3) which is used for fitting intestinal tract inner folds, and solid and/or liquid in the intestinal tract can enter the anastomotic stoma fistula-preventing device through the inlet reaming part (3) so as to protect intestinal tract wounds outside the contraction part (2);

the other end of the support braided body (1) is provided with an outlet reaming part (4) for allowing solid and/or liquid entering the anastomotic stoma fistula-preventing device to flow out.

5. The stoma fistula-preventing device according to claim 4, wherein an annular necking (5) is provided at an outer periphery of the inlet reamer part (3) close to the opening position, the annular necking (5) is outwardly flared towards an end of the inlet reamer part (3) far away from the constriction part (2) towards a direction far away from a centerline of the stoma fistula-preventing device, and a flaring angle is 0-60 ° so as to fit the intestinal tract.

6. The stoma fistula-prevention device according to claim 4, wherein the maximum diameter of the inlet reamer part (3) is 28-40 mm; the diameter of the annular necking (5) is 24mm to 36 mm.

7. The stoma fistula-preventing device according to claim 5, wherein the side of the annular constriction (5) facing the constriction portion (2) is further provided with degradable magnesium alloy spike-like barbs for fixation of the stoma fistula-preventing device; and/or the presence of a gas in the gas,

the coating at the location of the annular constriction (5) is provided with a developer coating for X-ray development; and/or the presence of a gas in the gas,

the central position of the contraction part (2) is provided with a metal developing ring for X-ray development.

8. The stoma fistula-preventing device according to claim 4, wherein the diameter of the outlet stoma portion (4) is 30mm to 50mm to fit in an intestinal tract plication fixation; and the axial length of the outlet reamer part (4) is 20mm to 40mm so as to prevent seepage from flowing to the contraction part (2) to contact with a wound.

9. Stoma fistula-preventing device according to claim 4, wherein the outlet reamer part (4) is provided with a flared angle at an angle of 5 ° to 45 ° towards the side facing away from the constriction (2) for securing the stoma fistula-preventing device and for letting out intestinal discharged matter.

10. The stoma fistula-preventing device according to claim 8, wherein the covering film at a position of the exit reamer part (4) on a side remote from the constricted part (2) has a developer coating for X-ray visualization; and/or the presence of a gas in the gas,

and a metal developing ring is arranged at one side of the outlet reaming part (4) far away from the contraction part (2) and is used for X-ray development.

11. The stoma fistula-preventing device according to claim 4, wherein the diameter of the constriction (2) is 20mm to 30 mm; and/or the presence of a gas in the gas,

the covering film at the position of the contraction part (2) is a high-compliance film material so as to be tightly attached to intestinal tissues; and/or the presence of a gas in the gas,

the covering film at the position of the contraction part (2) is made of waterproof and leakproof materials and can bear the pressure of at least 10 kPa;

the covering film at the position of the contraction part (2) is provided with a drug-loaded coating which is slowly released in the degradation process so as to inhibit inflammatory infection at the wound.

12. The anastomotic stoma fistula prevention device according to claim 1, wherein the stent braid (1) is a partially crystalline highly biocompatible shape memory degradable polymer comprising: at least one of polydioxanone, polylactide-ethylene glycol copolymer, polyglycolide-lactide copolymer, poly-L-lactide-D-lactide copolymer, polylactide-caprolactone copolymer, and degradable polyurethane.

13. A sealed storage cartridge for storing a stoma fistula-preventing device according to any one of claims 1 to 12, the stoma fistula-preventing device being in a released state within the sealed storage cartridge.

14. A cartridge for a stoma fistula-preventing device, characterized in that the cartridge (6) is for loading a stoma fistula-preventing device according to any one of claims 1 to 12 to an intestinal wall site;

the loader (6) comprises: the fistula-proof device comprises a connecting pipe (7) and a loading funnel (8) arranged at the end part of the connecting pipe (7), wherein the anastomosis fistula-proof device is accommodated in the connecting pipe (7); a traction rope (9) for loading the anastomotic stoma fistula-preventing device is arranged on the outlet reaming part (4);

the traction rope (9) is used for drawing the anastomotic stoma fistula-preventing device, so that the anastomotic fistula-preventing device is pressed and held to be loaded into the connecting pipe (7) through the loading funnel (8).