Digestive canal sheathing canal stent, stent system and use method

Abstract

The application discloses an alimentary canal sheathing canal stent which comprises a stent main body, the stent main body comprises a plurality of stent ribs and a recovery line, the plurality of stent ribs are woven pairwise to form a plurality of meshes with large middle parts and two sharp ends, and the plurality of meshes are connected pairwise and end to end along the radial direction through the edges on the middle parts of the meshes; the plurality of meshes are connected pairwise along the axial direction through the tips at the two ends of the meshes; the recovery line sequentially passes through the plurality of meshes on the near-end side in a forward and reverse winding manner, and a line knot is reserved, and the line knot can be pulled to fold the stent main body; the valve clack assembly comprises at least three valve clacks, a base and a connecting ring, the valve clacks are made of silica gel materials, the two ends of the at least three valve clacks are elastically attached in pairs and connected with the inner edge of the base, and the centers of the valve clacks are arranged in a protruding mode towards the far-end side and form concaves towards the near-end side. The center of the valve clack can be closed in the radial direction under the pressure applied from the far-end side to the near-end side, and the center of the valve clack can be opened in the radial direction under the pressure applied from the near-end side to the far-end side.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a digestive tract sheath tube stent, a stent system and a use method thereof. Background Art

[0002] Natural Orifice Transluminal Endoscopic Surgery (NOTES) refers to the use of a flexible endoscope to enter the abdominal cavity, thoracic cavity and other body cavities through natural cavities such as the mouth, esophagus, stomach, colon (rectum), vagina, bladder, etc., to perform various endoscopic operations, including abdominal exploration, peritoneal biopsy, liver biopsy, gastrointestinal and intestinal anastomosis, appendectomy, cholecystectomy, fallopian tube ligation, partial hysterectomy, nephrectomy, splenectomy, tail pancreatic resection, etc.

[0003] When performing NOTES surgery, it is usually necessary to use a mucosal cutter under endoscopy to cut through the stomach wall or intestines to make an opening in the digestive tract. The endoscope enters the body cavity through this opening and establishes pneumoperitoneum. Then, under the guidance of the endoscopic image, the surgical instruments are passed through the instrument channel of the endoscope to the target position. The movement of the endoscope drives the surgical instruments to treat the lesion at the target position in the body cavity.

[0004] A hole is made in the wall of the digestive tract as a passage for the endoscope to enter the body cavity. The hole directly connects the digestive tract cavity with the body cavity, but pollutants in the digestive tract can easily infect the body cavity. In addition, to treat lesions in the body cavity, since the organs in the body cavity are closely connected in the body cavity, it is necessary to inject gas into the body cavity to expand the body cavity to establish pneumoperitoneum and provide sufficient space conditions for endoscopic surgery. However, since the digestive tract is connected to the outside world of the human body, the gas in the body cavity leaks out from the digestive tract opening, making it difficult to establish pneumoperitoneum. Endoscopists use the endoscope to drive surgical instruments to treat lesions, and the body of the endoscope will also press on the digestive tract opening. Long-term endoscopic activity will expand the wall opening, thereby further damaging the digestive tract wall and increasing the difficulty of suturing the wall opening. Summary of the invention

[0005] The present invention provides a digestive tract sheath tube stent, a stent system and a method of use, which can isolate the digestive tract cavity from the body cavity space while providing an endoscope entry hole, protect the digestive tract wall, prevent further damage, reduce sterile cavity infection, and thus improve the quality of surgical treatment.

[0006] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0007] A digestive tract sheath tube stent, comprising: a stent body, the stent body comprising a plurality of stent ribs and a recovery line, the plurality of stent ribs being woven into a plurality of meshes with a large middle portion and sharp ends in pairs, the plurality of meshes being connected in pairs radially and end to end through the edges located in the middle thereof, and the plurality of meshes being connected in pairs axially through the sharp ends located at the ends thereof; the recovery line being wound in a forward and reverse manner through the plurality of meshes located at the proximal side in sequence and having a knot, the knot being pulled to close the stent body; a valve flap assembly, the valve flap assembly comprising at least three valve flaps, a base and a connecting ring, the valve flap being made of silicone The material is made of, the two ends of at least three valve flaps are elastically fitted in pairs and connected to the inner edge of the base, the center of the valve flap protrudes toward the distal side and is recessed toward the proximal side, the center of the valve flap can be radially closed under the pressure applied from the distal side to the proximal side, and the center of the valve flap can be radially opened under the pressure applied from the proximal side to the distal side; the support ribs are placed between the outer edge of the base and the inner edge of the connecting ring and connected thereto; the coating, one end of the coating located on the distal side covers the outer edge of the connecting ring and is connected thereto, and the entire coating is fixed by sutures and wrapped around the entire outer circumference of the support body.

[0008] Preferably, the stent body is in the shape of an I-shaped stent with wide ends and a narrow middle portion, the middle portion being used to engage with the incision opened in the digestive tract, one end of the stent body being placed in the digestive tract cavity, and the other end of the stent body being placed in the body cavity.

[0009] Preferably, the coating is fixedly wrapped around the middle section of the stent body and is formed to fit the shape of the stent body.

[0010] Preferably, the covering film is connected to the outer edge of the connecting ring by adhesive.

[0011] Preferably, the two ends of the valve flap form an angle of 120° with the center.

[0012] Preferably, the digestive tract sheath tube stent comprises at least two valve flap assemblies, and the valve flap assemblies are arranged in parallel on the distal end side and the proximal end side of the stent body.

[0013] Preferably, the stent ribs are made of medical memory metal.

[0014] Preferably, the support ribs are connected to the inner edge of the connecting ring and the outer edge of the base by casting.

[0015] Preferably, the connecting ring is a flat circular belt-shaped structure.

[0016] In order to achieve the above-mentioned object of the invention, the present invention also provides the following technical solutions:

[0017] A digestive tract sheath stent system includes the aforementioned digestive tract sheath stent and a conveyor. The conveyor can penetrate from the proximal side of the digestive tract sheath stent through the center of the valve flap assembly and extend from the distal side of the digestive tract sheath stent. The outer sleeve of the conveyor can place the folded digestive tract sheath stent in its inner cavity. The digestive tract sheath stent can follow the conveyor into the opening position opened in the digestive tract.

[0018] In order to achieve the above-mentioned object of the invention, the present invention also provides the following technical solutions:

[0019] A method for using a digestive tract sheath stent system, characterized in that the aforementioned digestive tract sheath stent is used, wherein: a conveyor is inserted from the proximal side of the digestive tract sheath stent through the center of a valve flap assembly and extended from the distal side of the digestive tract sheath stent; the digestive tract sheath stent is retracted and placed in the inner cavity of an outer sleeve of the conveyor; the digestive tract sheath stent enters the inner cavity of the digestive tract with the conveyor; the sheath stent is released, the middle part of the stent body is engaged with the opening opened in the digestive tract, one end of the stent body is placed in the inner cavity of the digestive tract, and the other end of the stent body is placed in the body cavity; the tip of the endoscope is passed through the inside of the stent body The endoscope is inserted into the body cavity and gas is injected into the body cavity through the gas supply function of the endoscope to expand the body cavity. When the gas pressure in the body cavity is greater than the pressure in the inner cavity of the digestive tract, the gas flows from the body cavity to the inner cavity of the digestive tract, and the valve flap pushes the valve flap to embrace the body of the endoscope under the pressure of the gas, thereby closing the opening in the digestive tract. After the diagnosis and treatment operation is completed, an instrument with a clamping function is inserted through the instrument channel of the endoscope, and the instrument hooks the knot of the retrieval line. The knot is pulled by the pulling force of the instrument and the mesh is gathered toward the center to return from the opening in the digestive tract to the inner cavity of the digestive tract. After that, the digestive tract sheath stent is withdrawn from the body of the body along with the endoscope.

[0020] The digestive tract sheath tube stent provided by the present invention combines the stent body with the valve flap assembly, and innovatively realizes one-way opening and closing through the opening and closing function of the valve flap assembly, so that on the one hand, it can be used to prevent the endoscope from directly contacting the digestive tract incision and causing damage to the human body during diagnosis and treatment, and on the other hand, it can smoothly construct pneumoperitoneum through one-way opening and closing. The digestive tract sheath tube stent provided by the embodiment of the present invention can be delivered into the human body through a conveyor, and the stent system is simple to use. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0022] Figure 1 It is a stereoscopic view of the digestive tract sheath stent in an embodiment of the present invention.

[0023] Figure 2 It is a cross-sectional view of the digestive tract sheath stent in an embodiment of the present invention.

[0024] Figure 3 It is a partial view of the distal end of the digestive tract sheath stent in an embodiment of the present invention, wherein the left view shows the valve flap assembly in a closed state, and the right view shows the valve flap assembly in an open state.

[0025] Figure 4 3D is a stereoscopic view of the valve flap assembly in an embodiment of the present invention, wherein the left image is a closed state and the right image is an open state.

[0026] Figure 5 1 is a top view of the valve flap assembly in an embodiment of the present invention, wherein the left figure shows a closed state and the right figure shows an open state.

[0027] Figure 6 Schematic diagram of the angle of the valve flap assembly in the embodiment of the present invention. DETAILED DESCRIPTION

[0028] The technical solution of the present invention is further specifically described below by examples and in conjunction with the accompanying drawings. In the specification, the same or similar reference numerals indicate the same or similar components. The following description of the embodiments of the present invention with reference to the accompanying drawings is intended to explain the overall inventive concept of the present invention and should not be construed as a limitation of the present invention.

[0029] In addition, in the detailed description below, for ease of explanation, many specific details are set forth to provide a comprehensive understanding of the disclosed embodiments. However, it is apparent that one or more embodiments may be implemented without these specific details. In other cases, known structures and devices are embodied in a schematic manner to simplify the accompanying drawings.

[0030] It should be noted that the wording "comprising" does not exclude other elements or steps, and the wording "one" or "an" does not exclude a plurality; the orientation or positional relationship indicated by "one end", "the other end", "inside", "outside", "front", "back", "distal side", "proximal side", etc. is based on the orientation or positional 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 a limitation on the present invention. "First" and "second" are used to distinguish the names of different components rather than for ranking or indicating importance or primary and secondary distinctions. In addition, any element number in the claims should not be understood as limiting the scope of the present disclosure.

[0031] During NOTES surgery, a hole needs to be cut in the digestive tract, and the hole needs to be closed when establishing pneumoperitoneum. The inventor has found that a stent that can be opened and closed can be placed in the digestive tract incision, which can solve the above technical problems.

[0032] According to an overall technical concept of the present invention, a digestive tract sheath stent comprises: a stent body, the stent body comprises a plurality of stent ribs and a recovery line, the plurality of stent ribs are woven into a plurality of meshes with a large middle portion and sharp ends, the meshes are radially connected in pairs through the edges located in the middle thereof and enclosed to form a shrinkable space, and the meshes are axially connected in pairs through the tips located at the two ends thereof; the recovery line is successively wound through the meshes located on the proximal side in a positive and negative direction and a knot is left, and the knot can be pulled to close the stent body; a valve flap assembly, the valve flap assembly comprises at least three valve flaps, a base The seat and the connecting ring, the valve flap is made of silicone material, the two ends of the valve flap are elastically fitted and connected to the inner edge of the base, the center of the valve flap protrudes toward the distal side and is recessed toward the proximal side, the center of the valve flap can be radially closed under the pressure applied from the distal side and the proximal side, and the center of the valve flap can be radially opened under the pressure applied from the proximal side to the distal side; the support ribs are placed between the outer edge of the base and the inner edge of the connecting ring and connected thereto; the coating, the end of the coating located on the distal side covers the outer edge of the connecting ring and is connected thereto, and the entire coating is fixed and wrapped around the outside of the support body by sutures.

[0033] In the embodiment of the present invention, the “distal side” refers to a direction close to a target operation position, and the “proximal side” refers to a direction close to an operator.

[0034] like Figures 1 to 6 As shown, in an embodiment of the present invention, a digestive tract sheath stent 100 includes a stent body 110 , a valve flap assembly 120 and a coating 130 .

[0035] The stent body 110 includes a plurality of stent ribs 111 and a recovery line 112. The plurality of stent ribs 111 are woven into a plurality of meshes 113 with large middle portions and sharp ends, that is, the meshes 113 are olive-shaped meshes as a whole. The meshes 113 include sharp ends at both ends, and edges connecting the sharp ends. The plurality of meshes 113 are connected in twos radially through the edges located in the middle thereof, and the edges of the first mesh 113 and the last mesh 113 are also connected, that is, connected end to end. The plurality of meshes 113 are connected in twos axially through the sharp ends located at both ends thereof. The plurality of meshes 113 are connected in twos radially and axially to enclose a retractable space for the endoscope to pass through, and the space is roughly cylindrical. The two sharp ends of the meshes 113 can provide a closing force toward the center of the mesh, which is convenient for storing and installing the entire stent into the conveyor, and for disassembling and recovering the entire stent from the opening of the digestive tract.

[0036] The retrieval line 112 is wound one positive and one negative in sequence through a plurality of meshes 113 located on the proximal side and has a knot 114, that is, the retrieval line 112 is placed on the proximal side of the entire stent as a whole, so as to facilitate the pulling of the instrument extended through the instrument channel of the endoscope. The retrieval line 112 has a knot 114, and the knot 114 can be pulled to close the stent body 110, and the diameter of the stent body 110 is reduced so that it can slide out of the digestive tract incision and return to the digestive tract cavity. "One positive and one negative" means that, in order, it first passes through a mesh 113 downwards, then passes through a mesh 113 upwards, and so on, the meshes 113 on the proximal side are connected in series in a "one positive and one negative" manner.

[0037] In some preferred embodiments, in order to further improve the shrinkage of the stent body 110, the stent ribs are made of medical memory metal, for example, nickel-titanium alloy. The medical memory metal can expand and recover to its original state, that is, it can be pinched and folded in a low temperature environment, and can recover to its original straight tube shape at room temperature or in the body.

[0038] In some preferred embodiments, the stent body 110 is in the shape of an "I" character with wide ends and a narrow middle part, that is, a "waist" is formed in the middle part of the stent body 110, and the diameter is expanded axially from the "waist" to the two ends, so that the stent body 110 is finally in the shape of an "I" character. When the digestive tract sheath stent is released, the waist in the middle part can be engaged with the incision opened in the digestive tract, one end (proximal side) of the stent body 110 can be placed in the inner cavity of the digestive tract, and the other end of the stent body 110 can be placed in the body cavity, so that the entire stent is stably stuck in the wall of the digestive tract. After the entire stent is stuck in the wall of the digestive tract, especially in the incision of the digestive tract, it is convenient for the endoscope to pass through the inside of the stent body 110 into the body cavity, so that the endoscope does not directly contact the digestive tract incision, avoiding the expansion of the incision due to the forward and backward movement during endoscopic diagnosis and treatment, and causing damage to the digestive tract.

[0039] The valve flap assembly 120 includes at least three valve flaps 121, a base 122 and a connecting ring 123. The valve flap 121 is made of a silicone material, which has a certain elasticity, so that the two ends of at least three valve flaps 121 can be elastically fitted in pairs and connected to the inner edge of the base 122. That is, the valve flaps 121 are connected to the inner edge of the base 122 on the one hand, and are elastically fitted in pairs at the ends on the other hand. The center of the valve flap 121 is protruding toward the distal side and is recessed toward the proximal side, that is, it is protruding when observed from the distal side and is recessed when observed from the proximal side. The center of the valve flap 121 can be opened and closed in the radial direction, and the center can be closed in the radial direction under the pressure applied from the distal side to the proximal side, that is, when the body cavity is filled with gas, the center of the valve flap 121 is closed under the pressure of the gas, so that the gas cannot flow from the body cavity to the digestive tract cavity, thereby smoothly establishing pneumoperitoneum. The greater the air pressure in the body cavity, the tighter the center of the valve flap 121 is closed. The center of the valve flap 121 can also be opened radially under the pressure applied from the proximal side to the distal side. For example, when the endoscope passes through the center of the valve flap 121 and enters the body cavity, it can be opened smoothly. For another example, when gas is input from the proximal side, the center of the valve flap 121 will be pushed by the gas pressure and separated, thereby opening the valve flap assembly 120. When the endoscope passes through the center of the valve flap 121, the valve flap 121 will simultaneously scrape off the body fluid of the endoscope to prevent the body fluid from entering the body cavity and contaminating the body cavity. After the endoscope enters the body cavity, the elasticity of the valve flap 121 will also make the valve flap 121 tightly fit on the body, so that the endoscope can be stably fixed on the bracket. The valve flap assembly 120 forms a one-way opening and closing channel between the valve flaps 121, that is, it can only be opened from the proximal side to the distal side, and cannot be opened from the distal side to the proximal side.

[0040] In some preferred embodiments, for the valve flap assembly 120 composed of three valve flaps 121, the two ends of the valve flap form an angle of 120° with the center. The drawings of the embodiments of the present invention only show the technical solution of three valve flaps 121, and the number of valve flaps 121 can also be set according to actual needs.

[0041] The support ribs 111 are placed between and connected to the outer edge of the base 122 and the inner edge of the connecting ring 123. In some preferred embodiments, the support ribs 111 are connected to the inner edge of the connecting ring 123 and the outer edge of the base 122 by casting.

[0042] In some preferred embodiments, the connecting ring is a flat circular belt-shaped structure.

[0043] The coating 130, one end of which is located on the distal side, covers the outer edge of the connecting ring 123 and is connected thereto, and the coating 130 as a whole is fixedly wrapped around the entire outer circumference of the stent body 110 by means of sutures 131. In some embodiments, the coating 130 is fixed to the middle section of the stent body 110 by being connected to the connecting ring 123 and is formed to fit the shape of the stent body 110, that is, the coating 130 is also in the shape of an "I" character that is wide at both ends and narrow in the middle. In some preferred embodiments, the coating 130 is connected to the outer edge of the connecting ring 123 by means of adhesive, and the adhesive can prevent the coating 130 from axial displacement, and can form a one-way opening and closing channel with a certain degree of sealing between the coating 130 and the valve flap assembly 120 placed on the stent body.

[0044] According to another overall technical concept of the present invention, a digestive tract sheath stent system includes the aforementioned digestive tract sheath stent 100 and a conveyor (not shown in the figure). The conveyor can penetrate from the proximal side of the digestive tract sheath stent 100 through the center of the valve flap assembly 110 and extend from the distal side of the digestive tract sheath stent 100. The outer sleeve of the conveyor can place the folded digestive tract sheath stent 100 in its inner cavity, and the digestive tract sheath stent 100 can enter the opening position opened in the digestive tract with the conveyor.

[0045] According to another overall technical concept of the present invention, a method for using a digestive tract sheath stent system uses the aforementioned digestive tract sheath stent, wherein: a conveyor is inserted from the proximal side of the digestive tract sheath stent through the center of the valve flap assembly and extended from the distal side of the digestive tract sheath stent; the digestive tract sheath stent is retracted and placed in the inner cavity of the outer sleeve of the conveyor; the digestive tract sheath stent enters the digestive tract cavity with the conveyor; the sheath stent is released, the middle part of the stent body is engaged with the opening opened in the digestive tract, one end of the stent body is placed in the digestive tract cavity, and the other end of the stent body is placed in the body cavity; the tip of the endoscope is inserted from the stent body into the digestive tract cavity, and the end of the endoscope is inserted into the end of the endoscope. The endoscope passes through the interior of the body and extends into the body cavity, and gas is injected into the body cavity through the gas supply function of the endoscope to expand the body cavity. When the air pressure in the body cavity is greater than the pressure in the inner cavity of the digestive tract, the gas flows from the body cavity to the inner cavity of the digestive tract, and the valve flap pushes the valve flap to embrace the body of the endoscope under the pressure of the gas, thereby closing the opening in the digestive tract; after the diagnosis and treatment operation is completed, an instrument with a clamping function is inserted through the instrument channel of the endoscope, and the instrument hooks the knot of the retrieval line. The knot is pulled by the pulling force of the instrument and the mesh is gathered toward the center to return from the opening in the digestive tract to the inner cavity of the digestive tract, and then the digestive tract sheath stent is withdrawn from the body of the human body along with the endoscope.

[0046] Specifically, the endoscopist inserts the conveyor from the proximal side of the digestive tract sheath tube stent provided by the present invention through the center of the valve disc until it extends out from the distal side of the stent. The inner cavity of the receiving tube section of the conveyor is aligned with the digestive tract sheath tube stent of the present invention. The entire stent is placed in a container filled with ice water and immersed in the ice water, and the stent is radially squeezed until the stent becomes smaller in the radial direction, so that it is axially contracted and elongated, and finally the outer sleeve of the conveyor places the contracted stent in its inner cavity.

[0047] The conveyor carrying the stent enters the human body along the guide wire device placed in advance in the human digestive tract until it reaches the opening of the digestive tract wall of the target human body. Under the guidance of the digestive endoscope image, the front end of the conveyor is inserted into the opening of the wall. When it is determined that the middle part (or waist) of the stent is aligned with the opening of the digestive tract wall, the endoscopist operates the conveyor to release the digestive tract sheath stent of the present invention. The distal side of the sheath stent first extends out of the outer sleeve of the conveyor, and the stent expands due to the human body temperature image, and the distal side of the stent is placed in the outside of the digestive tract, that is, in the body cavity; the stent is continuously released, and the middle part (or waist) of the stent is against the edge of the wall opening, and finally the proximal side of the stent is completely pushed out of the outer sleeve of the conveyor and placed in the digestive tract cavity. Because the stent is affected by the human body temperature image, the stent completely restores its original "I" shape, thereby stably clamping the stent in the wall of the digestive tract. The endoscopist holds the operating handle to withdraw the conveyor from the body.

[0048] The endoscopist operates the digestive endoscope insertion tube to slide freely from the proximal end of the stent body to the distal end of the stent body, thereby reaching the target position in the human body cavity. The digestive endoscope passes through the center of the valve flap in the stent, and the valve flap will fit tightly against the body of the digestive endoscope insertion tube, thereby scraping off the digestive tract fluid attached to the body of the endoscope insertion tube (or the body of the mirror) and allowing the fluid to fall back into the digestive tract.

[0049] Gas is injected into the human body cavity through the gas delivery function of the endoscope to expand the body cavity to establish a viewing field of view and surgical operation space (that is, to establish pneumoperitoneum). When the air pressure in the body cavity is greater than the air pressure in the digestive tract cavity, the gas will flow from the body cavity to the digestive tract cavity, and the valve flap will be squeezed by the gas, and the valve flap will be pushed and embraced on the insertion tube of the digestive endoscope, thereby closing the digestive tract opening and achieving the purpose of isolating the digestive tract cavity from the body cavity and sealing the body cavity.

[0050] After the diagnosis and treatment operation is completed, the endoscopist operates the digestive endoscope, enters the human body stent placement position, inserts the instrument with a clamping function from the instrument channel of the digestive endoscope, hooks the knot of the retrieval line at the proximal end of the stent under the guidance of the endoscopic image, and the endoscopist holds the endoscope and the clamping instrument to withdraw the stent from the body. Under the pulling force of the clamping instrument when the stent is withdrawn from the body, the retrieval line transmits the pulling force to close the mesh on the proximal side of the stent body inward, reducing the diameter of the stent body, so that the stent slides out of the opening of the digestive tract wall and returns to the digestive tract. The endoscopist holds the endoscope and uses the clamping instrument to withdraw the stent from the body.

[0051] The digestive tract sheath stent provided in the embodiment of the present invention combines the stent body with the valve flap assembly, and innovatively realizes one-way opening and closing through the opening and closing function of the valve flap assembly, so that on the one hand, it can be used to prevent the endoscope from directly contacting the digestive tract incision and causing damage to the human body during diagnosis and treatment, and on the other hand, it can smoothly construct pneumoperitoneum through one-way opening and closing. The digestive tract sheath stent provided in the embodiment of the present invention can be delivered into the human body through a conveyor, and the stent system is simple to use.

[0052] Those skilled in the art can understand that the embodiments described above are exemplary and can be improved by those skilled in the art. The structures described in various embodiments can be freely combined without causing conflicts in structure or principle.

[0053] Although the present invention has been described in conjunction with the accompanying drawings, the embodiments disclosed in the accompanying drawings are intended to exemplify the preferred implementations of the present invention and should not be construed as limiting the present invention.

[0054] Although some embodiments of the present general inventive concept have been shown and described, it will be appreciated by those skilled in the art that changes may be made to these embodiments without departing from the principles and spirit of the present general inventive concept, the scope of which is defined by the claims and their equivalents.

Claims

1. A digestive tract sheath stent, characterized in that include: The stent body comprises a plurality of stent ribs and a recovery line, wherein the plurality of stent ribs are woven into a plurality of meshes with a large middle portion and sharp ends in pairs, wherein the plurality of meshes are connected in pairs radially and end to end through the edges located in the middle thereof, and the plurality of meshes are connected in pairs axially through the sharp ends located at the two ends thereof; the recovery line is wound through the plurality of meshes located at the proximal side in a forward and reverse manner in sequence and a knot is left, and the knot can be pulled to close the stent body; A valve flap assembly, the valve flap assembly comprising at least three valve flaps, a base and a connecting ring, the valve flap being made of a silicone material, the two ends of at least three valve flaps being elastically fitted in pairs and connected to the inner edge of the base, the center of the valve flap being protruded toward the distal end and being recessed toward the proximal end, the center of the valve flap being radially closed under pressure applied from the distal end to the proximal end, and the center of the valve flap being radially opened under pressure applied from the proximal end to the distal end; the support rib being placed between the outer edge of the base and the inner edge of the connecting ring and being connected thereto; A coating, wherein one end of the coating located at the distal end covers the outer edge of the connecting ring and is connected thereto, and the entire coating is fixedly wrapped around the entire periphery of the exterior of the stent body by sutures.

2. The digestive tract sheath stent according to claim 1, characterized in that: The stent body is in the shape of an I-shaped character with wide ends and a narrow middle portion, wherein the middle portion is used to engage with an incision opened in the digestive tract, one end of the stent body can be placed in the digestive tract cavity, and the other end of the stent body can be placed in the body cavity.

3. The digestive tract sheath stent according to claim 2, characterized in that: The coating is fixedly wrapped around the middle section of the stent body and is formed in accordance with the shape of the stent body.

4. The digestive tract sheath stent according to claim 3, characterized in that: The covering film is connected to the outer edge of the connecting ring by adhesive.

5. The digestive tract sheath stent according to any one of claims 1 to 4, characterized in that: The two ends of the valve flap form an angle of 120° with the center.

6. The digestive tract sheath stent according to any one of claims 1 to 5, characterized in that: The digestive tract sheath tube stent comprises at least two valve flap assemblies, and the valve flap assemblies are arranged in parallel on the distal end side and the proximal end side of the stent body.

7. The digestive tract sheath stent according to any one of claims 1 to 6, characterized in that: The support ribs are made of medical memory metal.

8. The digestive tract sheath stent according to claim 7, characterized in that: The support ribs are connected to the inner edge of the connecting ring and the outer edge of the base through casting.

9. The digestive tract sheath stent according to claim 7, characterized in that: The connecting ring is a flat circular belt-shaped structure.

10. A digestive tract sheath stent system, characterized in that It comprises the digestive tract sheath stent and conveyor as described in any one of claims 1 to 9, wherein the conveyor can penetrate from the proximal side of the digestive tract sheath stent through the center of the valve flap assembly and extend from the distal side of the digestive tract sheath stent, the outer sleeve of the conveyor can place the folded digestive tract sheath stent in its inner cavity, and the digestive tract sheath stent can enter the opening position opened in the digestive tract along with the conveyor.

11. A method for using a digestive tract sheath stent system, characterized in that The digestive tract sheath stent according to claim 10 is used, wherein: The conveyor is inserted from the proximal side of the digestive tract sheath tube stent through the center of the valve flap assembly and extended from the distal side of the digestive tract sheath tube stent; The digestive tract sheath tube stent is folded up and placed in the inner cavity of the outer sleeve of the conveyor; the digestive tract sheath tube stent enters the inner cavity of the digestive tract along with the conveyor; The sheath stent is released, and the middle part of the stent body is engaged with the opening of the digestive tract, one end of the stent body is placed in the digestive tract cavity, and the other end of the stent body is placed in the body cavity; The tip of the endoscope is passed through the interior of the support body and extended into the body cavity, and gas is injected into the body cavity through the gas supply function of the endoscope to expand the body cavity. When the gas pressure in the body cavity is greater than the pressure in the inner cavity of the digestive tract, the gas flows from the body cavity to the inner cavity of the digestive tract, and the valve flap is pushed to embrace the body of the endoscope under the pressure of the gas, thereby closing the opening of the digestive tract; After the diagnosis and treatment operation is completed, an instrument with a clamping function is inserted through the instrument channel of the endoscope, and the instrument hooks the knot of the retrieval line. The knot is pulled by the pulling force of the instrument and the mesh is gathered toward the center to be withdrawn from the opening of the digestive tract into the inner cavity of the digestive tract. Then the digestive tract sheath stent is withdrawn from the body outside the body along with the endoscope.

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