CN115700110A

CN115700110A - Intestinal stent and intestinal stent assembly with inner and outer double-layer tectorial membrane

Info

Publication number: CN115700110A
Application number: CN202110875677.XA
Authority: CN
Inventors: 刘彩萍; 肖本好
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2021-07-30
Filing date: 2021-07-30
Publication date: 2023-02-07

Abstract

The invention relates to the technical field of medical instruments, in particular to an intestinal tract stent with an inner-outer double-layer coating and an intestinal tract stent assembly with the intestinal tract stent. This intestinal stent includes support subject and tectorial membrane, the support subject includes at least one metal wave circle, the surface of support subject is located to the tectorial membrane, the tectorial membrane includes interior tectorial membrane and covers the membrane outward, it locates the outside of interior tectorial membrane to cover the membrane outward, the distal end of interior tectorial membrane links to each other with covering the membrane outward, the near-end setting of the near-end of interior tectorial membrane exceeds outer tectorial membrane, the axial length of outer tectorial membrane is greater than the axial length of support subject, the support subject locates the axial length within range of outer tectorial membrane and is located or is close to the distal end of outer tectorial membrane. According to the intestinal stent and the intestinal stent assembly, the phenomenon that the intestinal canal is perforated due to extrusion on the intestinal wall caused by overlong length of the metal wave ring of the intestinal stent can be effectively reduced or avoided, and the use safety and reliability of the intestinal stent are improved.

Description

Intestinal tract stent and intestinal tract stent assembly with inner and outer double-layer covering films

Technical Field

The invention relates to the technical field of medical instruments, in particular to an intestinal stent with an inner-outer double-layer coating and an intestinal stent assembly with the intestinal stent.

Background

Various stents have been used in the digestive tract for a long time. The stent can be placed in the esophagus, cardia, biliary tract and colon with stenotic lesion no matter the stent is hard, soft, air sac or water sac, coated with a reticular film, or made of memory alloy, or the stent is expanded after reaching the position or the two ends of the stent have an expansion structure.

In the clinical treatment of rectal cancer, operations for low-level and very low-level retention of the anus are becoming mature day by day. However, even after the internal anal sphincter is removed and the internal sphincter aniectomy (IRS) is performed, the incidence rate of temporary fecal incontinence is very high, and the incidence rate is 70 to 80% in 3 months according to the comprehensive literature data, but the recovery rate is 90% after three months, which causes the state of fecal incontinence for several months after the operation of the patient, and even if the diaper is worn, the abnormal odor and the local filth cannot be prevented. The current solution is to perform prophylactic colostomy, but the colostomy itself has complications and requires a half year post-operative procedure to be performed, which increases the pain and burden on the patient.

If the intestinal tract bracket is connected with the excrement containing device, excrement can be effectively collected, and peculiar smell diffusion and local filth can be prevented. However, most of the existing stents are made of superelastic memory alloy and placed in the intestinal tract to extrude the intestinal wall, and no taking-out device is arranged on the stent, so that the stent is supported in the intestinal tract for a long time, and erosion perforation is inevitable. In addition, the existing intestinal tract bracket and the excrement containing device are connected with two problems, and firstly, the connection operation is too complex, so that the replacement is troublesome. Secondly, the connection design is unreasonable, and the excrement is easy to leak when the excrement containing device is replaced.

Disclosure of Invention

The invention aims to at least solve the problem that the intestinal bracket extrudes the intestinal wall to cause intestinal perforation. This object is achieved by:

a first aspect of the present invention proposes an intestinal stent comprising:

a stent body comprising at least one metallic undulating ring;

the tectorial membrane is located the surface of stent main part, the tectorial membrane includes interior tectorial membrane and covers the membrane outward, it locates to cover the membrane outward the outside of interior tectorial membrane, the distal end of interior tectorial membrane with it links to each other to cover the tectorial membrane outward, the near-end of interior tectorial membrane surpasss the near-end of outer tectorial membrane, the axial length of outer tectorial membrane is greater than the axial length of stent main part, stent main part is located the axial length within range of outer tectorial membrane is located or is close to the distal end of outer tectorial membrane.

According to the intestinal stent, the metal wave ring is arranged at the far end or the position close to the far end of the covering film, one end of the covering film provided with the metal wave ring is inserted into the intestinal tract, so that the intestinal stent is installed and positioned, the normal dredging of excrement in the intestinal tract by the intestinal stent is ensured, meanwhile, the other end of the covering film is not provided with the metal wave ring, the other end of the covering film can be arranged outside the intestinal tract, the length of the metal wave ring in the intestinal tract can be effectively reduced, the phenomenon that the intestinal tract is perforated due to extrusion on the wall of the intestinal tract caused by overlong length of the metal wave ring of the intestinal stent is reduced or avoided, and the safety and the reliability of the use of the intestinal stent are improved. And meanwhile, the inner layer and the outer layer of covering films are arranged, so that the leakage-proof effect can be realized.

In addition, the intestinal stent according to the invention can also have the following additional technical characteristics:

in some embodiments of the invention, the intestinal stent further comprises a fixed connector disposed at or near the proximal end of the outer cover.

In some embodiments of the present invention, the outer coating film and the inner coating film have an overlapping region in which a plurality of connection holes are formed on the outer coating film, and the fixing connection member is inserted into the connection holes. In some embodiments of the invention, the fixed connection is a flexible wire-like structure or an elastic loop.

In some embodiments of the present invention, the intestinal stent further includes a covering tube, the covering tube is a tubular structure with two open ends, the covering tube is annularly disposed at a position at or near a proximal end of the outer covering film, the two open ends of the covering tube are spaced and oppositely disposed, the fixing connector includes an annular structure with a notch, and the fixing connector can be inserted into the interior of the covering tube through the opening at one end of the covering tube.

In some embodiments of the present invention, the proximal end of the outer covering membrane is at least partially folded inwardly to form at least one inwardly folded portion, the inwardly folded portion is located between the outer covering membrane and the inner covering membrane, and the inwardly folded portion is connected to the outer covering membrane or/and the inner covering membrane.

The invention further provides an intestinal tract bracket assembly, which comprises the intestinal tract bracket, and further comprises a container, wherein the container comprises a cavity part and a connecting part, the cavity part is internally provided with a containing cavity, the connecting part is provided with a connecting port communicated with the containing cavity, the proximal end of the inner coating film can be inserted into the connecting port, and the proximal end of the outer coating film is positioned outside the connecting part.

In some embodiments of the present invention, the outer covering film is provided with a plurality of connecting holes, the connecting portion is provided with a plurality of mounting holes, and the mounting holes and the connecting holes are connected through fixing connectors.

In some embodiments of the present invention, the connecting portion is provided with a radial protrusion, the proximal end of the outer coating is sleeved outside the radial protrusion, and a fixed connector is provided at a position at or near the proximal end of the outer coating and fixes the outer coating and the radial protrusion; or, the connecting part is provided with a radial groove, the near end of the outer coating film is sleeved outside the radial groove, a part of the outer coating film, which corresponds to the radial groove, is provided with a fixed connecting piece, and the fixed connecting piece is connected with the outer coating film and the radial groove.

In some embodiments of the present invention, the connecting portion is provided with an outer clamping portion folded outwards, the proximal end of the outer covering film is provided with an inner folded portion, and the outer clamping portion is inserted between the inner folded portion and the outer covering film.

Drawings

Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like parts are designated with like reference numerals throughout the drawings. Wherein:

fig. 1 is a schematic structural view of an intestinal stent according to an embodiment of the present application;

FIG. 2 is a schematic view of the fixed connection member of FIG. 1;

FIG. 3 is a schematic view of an intestinal stent assembly having the intestinal stent of FIG. 1;

FIG. 4 is a schematic view of the structure of the container shown in FIG. 3;

FIG. 5 is a schematic view of the root structure of the intestine;

FIG. 6 is a schematic view of the intestinal stent assembly of FIG. 3 in an intestinal tract;

fig. 7 is a schematic structural view of an intestinal stent according to an embodiment of the present application;

FIG. 8 is a schematic view of the fixed connection of FIG. 7;

fig. 9 is a schematic structural view of an intestinal stent according to an embodiment of the present application;

FIG. 10 is a schematic view of the intestinal stent of FIG. 9 in a partially cross-sectional configuration;

FIG. 11 is a schematic view of a container according to an embodiment of the present disclosure;

fig. 12 is a schematic structural view of an intestinal stent according to an embodiment of the present application;

FIG. 13 is a schematic view of the intestinal stent of FIG. 12 in a partially sectioned configuration;

fig. 14 is a schematic structural view of an intestinal stent assembly having the intestinal stent of fig. 12;

FIG. 15 is a schematic view of the arcuate structure of FIG. 14;

FIG. 16 is a schematic view of the receptacle of FIG. 14;

fig. 17 is a schematic structural view of an intestinal stent according to an embodiment of the present application;

FIG. 18 is a schematic structural view of the inner cover film of FIG. 17;

fig. 19 is a schematic structural view of an intestinal stent assembly having the intestinal stent of fig. 18;

FIG. 20 is a schematic view of the receptacle of FIG. 19;

fig. 21 is a schematic structural view of a container according to an embodiment of the present application;

fig. 22 is a schematic structural view of an intestinal stent according to an embodiment of the present application;

fig. 23 is a schematic structural view of an intestinal stent according to an embodiment of the present application;

fig. 24 is a schematic structural view of an intestinal stent according to an embodiment of the present application;

FIG. 25 is a schematic view, partly in section, of the intestinal stent of FIG. 24;

fig. 26 is a schematic structural view of a container according to an embodiment of the present application;

fig. 27 is a schematic view of an intestinal stent according to an embodiment of the present application;

fig. 28 is a schematic structural view of an intestinal stent according to an embodiment of the present application;

fig. 29 is a schematic structural view of an intestinal stent according to an embodiment of the present application;

FIG. 30 is a schematic view of the intestinal stent of FIG. 29 with the contraction rod removed;

FIG. 31 is a schematic view of the collapsible rod of FIG. 29;

fig. 32 is a schematic structural view of an intestinal stent according to an embodiment of the present application;

FIG. 33 is a schematic view of the structure of the cover shown in FIG. 32;

FIG. 34 is a schematic view of a shrink tube mated with the film cover of FIG. 33.

Detailed Description

Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It should also be understood that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For convenience in description, the relationship of one element or feature to another element or feature as illustrated in the figures may be described herein using spatially relative terms, such as "inner", "outer", "lower", "below", "upper", "over", and the like. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "at 8230; \8230; below" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

For purposes of more clearly describing the structure of the present application, the terms "proximal" and "distal" are defined herein as terms customary in the field of interventional medicine. Specifically, "distal" refers to the end that is distal from the operator during a surgical procedure, "proximal" refers to the end that is proximal to the operator during a surgical procedure, "axial" refers to its length, "radial" refers to a direction that is perpendicular to the "axial" direction.

Referring to fig. 1 to 4, in one embodiment of the present application, the intestinal stent assembly 1 has an intestinal stent 100 and a container 200.

The intestinal stent 100 includes a stent body 10 and a coating film 20, and the stent body 10 has a plurality of metal wave rings 11 arranged at intervals in the axial direction. The cover film 20 is a cylindrical structure with two open ends, the cover film 20 extends along the axial direction of the stent main body 10, the axial length of the cover film 20 is larger than that of the stent main body 10, and the stent main body 10 is arranged in the axial length range of the cover film 20 and is positioned at or close to one end of the cover film 20. In other embodiments, the cover 20 may not extend in the axial direction of the stent body 10, and may extend in a direction at an angle to the axial direction of the stent body 10.

The container 200 includes a cavity 210 and a connecting portion 220, the cavity 210 has a receiving cavity (not shown), the connecting portion 220 has a connecting port 221 communicating with the receiving cavity, and the other end of the cover film 20 opposite to the stent body 10 is inserted into the connecting port 221.

In a specific use of the intestinal stent assembly 1 of the present embodiment, the intestinal stent 100 is implanted into an intestinal tract, the container 200 is placed outside the body, and one end of the container 200 is located closer to an operator, so that one end of the intestinal stent 100 provided with the metal wave ring 11 is defined as a distal end, and the other end of the intestinal stent 100 located opposite to the metal wave ring 11 is defined as a proximal end (not limited to the present embodiment, and this definition is adopted in all embodiments of the present invention). It will be appreciated that the intestinal stent 100 may be used alone without the need to engage the receptacle 200.

Specifically, a material having good biocompatibility, good sealing, and smoothness, such as ePTFE (expanded polytetrafluoroethylene), PTFE (tetrafluoroethylene) material, or the like, is used for the covering membrane 20 in the present embodiment.

A plurality of wave crests and wave troughs are arranged on the single metal wave ring 11, and the wave crests and the wave troughs are connected through a linear rod to form a cylindrical wave ring, which can be cylindrical in the figure 1 and can also be in various shapes suitable for the anatomical structures of intestinal tracts. For the stent main body 10, the radial supporting force of the far end can be set to be larger than that of the near end, the radial supporting force of the far end greatly ensures the good anchoring and sealing problem of the far end, the radial supporting force of the near end is small, and the damage of the intestinal wall caused by the large pressure on the intestinal wall is avoided. The stent main body 10 is set to have a small diameter at the far end and a large diameter at the middle, so that the stent main body can be well attached to the rectal wall and leakage is avoided. In one embodiment, silicone is fixed on the outer surface or the inner surface of the distal end of the stent main body 10 to increase the sealing performance of the distal end, the silicone is in a sponge shape, and the covering membrane 20 is turned outwards or inwards to wrap and fix the silicone.

The number of the metal wave rings 11 may be one or more, preferably two or more, and the metal wave rings 11 are made of a material having good biocompatibility and good elasticity, such as nitinol or stainless steel. The metal bellows 11 is provided only at the distal end of the coating film 20, and the metal bellows 11 is bonded to the coating film 20 by high-temperature pressurization. Specifically, the metal bellows 11 may be disposed inside or outside the cover film 20 and connected to the distal end of the cover film 20 or a position near the distal end. In an embodiment, when the metal wave ring 11 is disposed outside the covering membrane 20, an outward-folded section (not shown in the figure) may be further disposed at the distal end of the covering membrane 20, the outward-folded section is disposed outside the covering membrane 20 and folded toward the proximal end of the covering membrane 20, and the length of the outward-folded section covers the metal wave ring 11, so as to wrap the metal wave ring 11 between the outward-folded section and the distal end of the covering membrane 20, thereby effectively preventing the metal wave ring 11 from scratching the intestinal wall. It is understood that the cover film 20 may be a one-layer film structure, and may also be a multi-layer film structure, and when the cover film 20 is a multi-layer film structure, the metal wave ring 11 may be disposed between the multi-layer film structures.

Referring again to fig. 1 to 3, in one embodiment, the intestinal stent 100 further includes a fixed connector, which is disposed outside or inside the other end of the covering membrane 20, i.e., outside or inside the proximal end of the covering membrane 20. In other embodiments, a fixed connection may be provided in the cover 20 near the other end. The fixing connector in this embodiment is an elastic ring 31, and the elastic ring 31 is attached to the cover film 20. In the present embodiment, the elastic ring 31 is a continuous annular structure, and the elastic ring 31 is made of a material with good biocompatibility and good elasticity, such as nitinol or stainless steel. In other embodiments, the elastic ring 31 may have a wavy annular structure, a zigzag annular structure, or the like.

The connecting portion 220 of the present embodiment is made of a material having good elongation and resilience, such as silicone rubber or latex. In order to ensure that the connecting part 220 can stretch and rebound and is hung on the intestinal tract bracket 100, the axial length of the connecting part 220 is more than 5mm. One end of the cavity 210 is connected to the connection part 220, and the other end is closed, and the material is preferably a polymer. When the proximal end of the covering membrane 20 is inserted into the connecting portion 220, the connecting portion 220 is stretched to deform and enlarge the connecting port 210, so that the end of the covering membrane 20 having the elastic ring 31 is inserted into the connecting port 210, and the elastic ring 31 is clamped into the connecting port 221 by the deformed connecting portion 220, so that the intestinal tract stent 100 and the container 200 are connected.

Referring to fig. 3, 5 and 6, when collecting the stool 400 by using the intestinal stent assembly 1 of the present embodiment, the intestinal stent 100 is firstly compressed in a delivery device (not shown), and then the intestinal stent 100 is delivered and implanted into the intestine 300, wherein the end of the stent body 10 on the covering film 20 is placed under the lower rectal flap 330, the whole stent body 10 is supported between the lower rectal flap 330 and the anal canal internal orifice 310, the end of the stent body 10 on the covering film 20 is attached to the rectal wall to form a seal, and the end of the elastic ring 31 on the covering film 20 is kept outside the anal canal external orifice 320. Finally, one end of the elastic ring 31 arranged on the covering film 20 is inserted into the connecting port 221 of the connecting part 220, so that the container 200 and the intestinal tract bracket 100 are connected and fixed. The stool 400 passes through the intestine 300 and the intestine stent 100, and is finally introduced into the collecting container 200. Since the container 200 is disposed outside the body, it can be replaced at any time according to actual conditions.

As shown in fig. 1, the axial length of the stent body 10 is in the range of 20 to 50mm, that is, the total length of the metal wave ring 11 in the axial direction of the enteric stent 100 is in the range of 20 to 50mm, and in the present embodiment, the axial length of the stent body 10 is 40mm. The metal wave ring 11 of the present embodiment is fixed between the lower rectal flap 330 and the internal anal opening 310, and if the total length of the metal wave ring 11 in the axial direction of the intestinal stent 100 is too short, the fixation is not firm and displacement is likely to occur; if the total length of the metal wave ring 11 in the axial direction of the intestinal stent 100 is too long, the rectal flap and the rectal column are easily squeezed, and erosion and perforation of the intestinal tract are caused.

As further shown in FIG. 1, the axial length of the stent body 10 between the end facing the fixed connector and the fixed connector is in the range of 55 to 65mm, thereby facilitating the connection between the proximal end of the cover 20 and the housing 200. In this embodiment, the axial length between the end of the stent body 10 facing the fixed connector and the fixed connector is 60mm.

As shown in fig. 7 and 8, in one embodiment, the intestinal stent 100 further comprises a coated tube 40. The film coating tube 40 is a tubular structure with two open ends, and is annularly arranged at the other end of the film coating tube 40 or a position close to the other end, and the two open ends of the film coating tube 40 are spaced and oppositely arranged. The fixed connection comprises a split ring 32 with a notch, the split ring 32 being insertable through an end opening of the coated tube 40 into the interior of the coated tube 40.

The coated tube 40 can be made of a material with good biological properties, such as ePTFE (expanded polytetrafluoroethylene), PTFE (tetrafluoroethylene), PET (polyester resin) or PE (polyethylene), the coated tube 40 has a structure with two open ends and a sealed middle, and is surrounded along the axial direction of the intestinal stent 100, and the connection mode can be integrally formed with the coating 20, or bonded or sewn. In the present embodiment, the film-coated tube 40 is made of ePTFE.

The split ring 32 is made of a material having a certain hardness and support, such as a polymer or a metal. Polymers such as POM (polyoxymethylene), metals such as stainless steel. The split ring 32 may be threaded into the coated tube 40, with the split ring 32 having a cross-sectional area smaller than the cross-sectional area of the coated tube 40 to facilitate insertion of the split ring 32 within the coated tube 40.

Compared with the implementation mode adopting the elastic ring 31, due to the arrangement of the film coating pipe 40, the split ring 32 is not required to be placed in the conveying device firstly, subsequent rebound is not required, the limitation on the volume and the material is small, the material with larger sectional area can be selected, and the material with better support can be selected, so that the risk that the subsequent container 200 is connected to the intestinal tract bracket 100 and falls off is reduced. After the intestinal stent 100 is placed in the intestinal tract 300, the split ring 32 is inserted into the stent graft 40 of the intestinal stent 100, so as to form a strong radial support at the proximal end of the intestinal stent 100, and the end of the stent graft 20 having the split ring 32 is inserted into the connection port 221, thereby realizing the connection between the intestinal stent 100 and the container 200 in this embodiment.

As shown in fig. 9 and 10, in one embodiment, the other end of the cover 20 opposite to the stent body 10 is provided with an outward folded part 21, the outward folded part 21 is provided outside the cylindrical structure formed by the cover 20 and folded toward the stent body 10, and the outward folded part 21 is connected to the metal wave ring 11 or the cover 20. Specifically, the flexible members 40 are connected by at least one flexible member 40, and the flexible members 40 may be linear members.

Further, the enteric stent 100 of the present embodiment further includes a fixed connecting element, the fixed connecting element is disposed between the eversion fold 21 and the covering membrane 20, and the fixed connecting element may be an open ring 32 in fig. 8, or an elastic ring 31 in fig. 2, or another fixed structure with a supporting force, so as to form a stable radial support between the eversion fold 21 of the enteric stent 100 and the covering membrane 20. After the intestinal stent 100 is implanted into the intestinal tract 300, the connecting port 221 is enlarged after being deformed by stretching the connecting portion 220, so that the connecting portion 220 is sleeved at one end of the covering membrane 20, which is provided with the outward-folded portion 21, and one end of the intestinal stent 100, which is provided with the fixed connecting piece, is clamped in the connecting port 221 through the deformed connecting portion 220, thereby realizing the connection between the intestinal stent 100 and the container 200.

Further, as shown in fig. 11, in the present embodiment, one end of the connecting portion 220 disposed toward the intestinal stent 100 is provided with an inner engagement portion 222 folded inward, and the inner engagement portion 222 extends toward the inside of the cavity portion 210. When the intestinal stent 100 in fig. 9 and 10 is connected to the container 200 in fig. 11, the connecting port 221 of the container 200 is sleeved on the proximal end of the covering film 20, the distal end of the outward folded part 21 is closer to the proximal end of the container 200 than the proximal end of the inner clamping part 222, and then the container 200 is pulled towards the proximal end, so that the inner clamping part 222 is inserted between the outward folded part 21 and the covering film 20, and the container 200 is hung on the proximal end of the intestinal stent 100. In this embodiment, the outward folded part 21 and the metal wave ring 11 are connected by the flexible member 50, so that the outward folded part 21 can form a stable hanging structure, thereby effectively preventing the container 200 from falling off the intestinal tract stent 100. It will be appreciated that when the connecting portion 220 of the receptacle 200 has the inner engagement portion 222, the intestinal stent 100 may not include a fixed connector, and only the outer folded portion 21 is required.

According to this embodiment's intestinal support 100 and intestinal support subassembly 1, only set up metal ripples circle 11 in the one end of tectorial membrane 20, implant to intestinal 300 through tectorial membrane 20 one end that will be equipped with metal ripples circle 11, thereby install the location to intestinal support 100, guarantee intestinal support 100 to the normal conduction process of excrement and urine 400 in the intestinal 300, the other end of tectorial membrane 20 does not have the metal ripples circle to set up simultaneously, can set up the other end of tectorial membrane 20 in the outside of intestinal 300, can reduce the length of metal ripples circle 11 in the intestinal effectively, thereby reduce or avoid causing the emergence of extrusion and lead to intestinal 300 perforation phenomenon because of intestinal support 100's metal ripples circle 11 length overlength to the intestinal wall, improve the security and the reliability of intestinal support 100 use. Meanwhile, in the embodiment, the proximal end of the coating 20 is placed outside the intestinal tract 300, so that the intestinal tract stent 100 can be pulled outside the body at any time to move the intestinal tract stent 100 out of the intestinal tract 300, thereby facilitating the taking out of the intestinal tract stent 100.

Referring to fig. 12 to 16, in one embodiment of the present application, the intestinal stent assembly 1 includes an intestinal stent 100 and a container 200. As shown in fig. 12 and 13, in the present embodiment, the intestinal stent 100 includes a stent body 10 and a coating 20. The stent body 10 has a plurality of metal bellows 11 arranged at intervals in the axial direction. The covering membrane 20 is a cylindrical structure with two open ends, the covering membrane 20 is arranged on the surface of the stent main body 10, the covering membrane 20 comprises an inner covering membrane 22 and an outer covering membrane 23 which are arranged along the axial direction of the stent main body 10 in an extending way, the outer covering membrane 23 is arranged outside the inner covering membrane 22, the far end of the inner covering membrane 22 is connected with the outer covering membrane 23, the near end of the inner covering membrane 22 exceeds the near end of the outer covering membrane 23, the axial length of the outer covering membrane 23 is greater than that of the stent main body 10, and the stent main body 10 is arranged in the axial length range of the outer covering membrane 23 and is positioned at or close to the far end of the outer covering membrane 23.

The structure of the stent main body 10, the structure and the material of the metal wave ring 11 in the stent main body 10 are the same as those of the above embodiment, and the materials of the inner coating 22 and the outer coating 23 are the same as those of the coating in the above embodiment, and are not described again.

As shown in fig. 12 to 14, in the present embodiment, the outer cover film 23 and the inner cover film 22 have an overlapping region, and in the overlapping region, a plurality of connection holes 24 are formed in the outer cover film 23, and the plurality of connection holes 24 penetrate through the outer cover film 23. It will be appreciated that this overlap region is located at or near the proximal end of the outer covering membrane 23.

As shown in fig. 16, in the present embodiment, the container 200 includes a cavity 210 and a connecting portion 220, the cavity 210 has a cavity (not shown), the connecting portion 220 has a connecting port 221 communicating with the cavity, the proximal end of the inner film 22 is inserted into the connecting port 221, and the proximal end of the outer film 23 is located outside the connecting portion 220. The connecting portion 220 is further provided with a plurality of mounting holes 223, and the mounting holes 223 penetrate through the side wall of the connecting portion 220. The mounting hole 223 and the coupling hole 24 are coupled by a fixing coupling member.

The intestinal tract stent assembly 1 of the present embodiment is inserted into the mounting hole 223 and the connection hole 24 through the fixing connector, and the container 200 is hung on the proximal end of the intestinal tract stent 100. Because the container 200 is only hooked with the intestinal tract stent 100, the container 200 does not need to be tightly sleeved outside the intestinal tract stent 100, and therefore, the container 200 does not need to consider the requirements of elongation and elasticity, and the strength and rigidity of the container 200 can be further improved, so that the use reliability of the intestinal tract stent assembly 1 is improved, and the detachment between the container 200 and the intestinal tract stent 100 is facilitated.

Specifically, as shown in fig. 14 and 15, in the present embodiment, the fixed connecting member is an arc-shaped structure 33, and the arc-shaped structure 33 includes a first arc-shaped portion 331, a second arc-shaped portion 332, and a third arc-shaped portion 333, wherein an opening direction of the first arc-shaped portion 331 is the same as an opening direction of the third arc-shaped portion 333, an opening direction of the first arc-shaped portion 331 is opposite to an opening direction of the second arc-shaped portion 332, the first arc-shaped portion 331 and the third arc-shaped portion 333 are respectively connected to two ends of the second arc-shaped portion 332, the second arc-shaped portion 332 is inserted into the mounting hole 223 of the connecting portion 220, and the first arc-shaped portion 331 and the third arc-shaped portion 333 respectively extend from two ends of the second arc-shaped portion 332 and are respectively inserted into two connecting holes 24 which are arranged at an interval, so as to realize the hooking between the container 200 and the intestinal tract support 100. In other embodiments, the fixing connector may have various shapes such as a C-shaped structure, an S-shaped structure, etc., as long as it can be hooked into the mounting hole 223 and the connection hole 24 to fixedly connect the container 200 and the intestinal stent 100.

Referring to fig. 5 and fig. 12 to 16, when collecting stool using the intestinal stent assembly 1 of the present embodiment, the intestinal stent 100 is first compressed in a delivery device (not shown), and then the intestinal stent 100 is delivered and implanted into the intestine, wherein the end of the cover 20 supported by the stent body 10 is placed under the lower rectal flap 330, the entire stent body 10 is supported between the lower rectal flap 330 and the anal canal inner opening 310, the end of the cover 20 supported by the stent body 10 is attached to the rectal wall to form a seal, and the end of the cover 20 provided with the connecting hole 24 is left outside the anal canal outer opening 320. Finally, the fixing connection between the container 200 and the intestinal stent 100 is realized by fixing the connecting member (such as the arc-shaped structure 33) through the mounting hole 223 and the connecting hole 24. The stool passes through the intestine 300 and the intestine supporter 100, and is finally introduced into the collecting container 200.

Further, as shown in fig. 17 to 19, the outer coating film 23 of an embodiment is provided without a connecting hole, the inner coating film 22 includes a connecting section 26 and an inserting section 27, and the radial dimension of the inserting section 27 is smaller than that of the connecting section 26, so that the proximal end of the inner coating film 22 can be inserted into the connecting section 220. The distal end of the outer covering film 23 is connected with the distal end of the connecting section 26, and the proximal end of the outer covering film 23 is arranged corresponding to the insertion section 27, so that a gap is left between the outer covering film 23 and the insertion section 27, and the outer covering film 23 is ensured to be sleeved outside the connecting portion 220. In another embodiment, the inner cover film 22 may not include the connecting segment 26, but only include the insertion segment 27, wherein the distal end of the insertion segment 27 is directly connected to the outer cover film 23, and the remaining portion is directly separated from the outer cover film 23.

Further, in this embodiment, the intestinal stent 100 also includes a fixed connector provided at or near the proximal end of the outer covering membrane 23. As shown in fig. 19, the fixed connection member in the present embodiment is a flexible linear structure 34 made of a polymer material. The insertion section 27 of the inner cover 22 is inserted into the connecting portion 220, and after the outer cover 23 is fitted over the connecting portion 220, the outer cover 23 is tied to the connecting portion 220 by the flexible linear structure 34.

Referring to fig. 19 and 20, in the present embodiment, the connecting portion 220 is provided with a radial protrusion 224, the proximal end of the outer covering film 23 is sleeved outside the radial protrusion 224, and the proximal end or a position near the proximal end of the outer covering film 23 is provided with the flexible threadlike structure 34. In this embodiment, the radial projection 224 is an annular radial projection. The radial protrusion 224 is made of a material with certain hardness, such as POM (polyoxymethylene) or stainless steel. By providing the radial protrusion 224 and fixing the radial protrusion 224 in the cylindrical structure formed by the outer covering film 23 through the flexible wire-like structure 34, the flexible wire-like structure 34 is made to contact with the proximal end surface of the radial protrusion 224, so that the connection strength between the intestinal stent 100 and the container 200 can be further improved, and the container 200 can be prevented from falling off from the intestinal stent 100. Meanwhile, the insertion section 27 of the inner film 22 is inserted into the connection part 220, so that leakage of feces can be prevented. In other embodiments, the radial protrusion 224 may have a dot-shaped or block-shaped structure, the radial protrusion 224 may be multiple, and the multiple radial protrusions 224 are distributed on the connecting portion 220.

As further shown in fig. 21, in one embodiment, the connecting portion 220 is provided with a radial groove 225, the proximal end of the outer covering film 23 is sleeved outside the radial groove 225, and the portion of the outer covering film 23 corresponding to the radial groove 225 is provided with the flexible thread-like structure 34. In the present embodiment, the radial groove 24 is an annular radial groove. The connecting portion 220 in the present embodiment also has a certain hardness, thereby facilitating the connection and fixation of the outer coating 23.

Referring again to fig. 22, in one embodiment, the fixed connection is an elastic ring 31 of fig. 2. The elastic ring 31 can be directly fixed on the outer coating film 23, after the outer coating film 23 is sleeved outside the connecting portion 220, the outer coating film 23 is fixedly connected on the connecting portion 220 through the close fit of the elastic ring 31 and the outer surface of the connecting portion 220, wherein the outer surface of the connecting portion 220 can be provided with radial protrusions, radial grooves or smooth arrangement. Due to the certain hardness of the elastic ring 31, the container 200 can be prevented from slipping from the connection position, so that the connection between the container 200 and the intestinal tract bracket 100 is more tight. The connecting portion 220 in the present embodiment also has a certain hardness, thereby facilitating the connection and fixation of the outer coating 23. It will be appreciated that the proximal end of the outer covering film 23 may also be looped with a flexible wire-like structure 34, so as to avoid the container 200 and the intestinal stent 100 from slipping off due to the elastic ring 31.

Referring again to fig. 23, in one embodiment, the fixed connection includes a split ring 32 having a notch. The intestinal stent 100 further comprises a coated tube 40, the coated tube 40 is a tubular structure with two open ends, the coated tube 40 is annularly arranged at the near end of the outer coated membrane 23 or at a position close to the near end, and the two open ends of the coated tube are spaced and oppositely arranged. When the container 200 and the intestinal stent 100 are connected, firstly, the proximal end of the inner covering membrane 22 is inserted into the connecting portion 220, the outer covering membrane 23 is sleeved outside the connecting portion 220, then the split ring 32 is inserted into the covering membrane tube 40 through the opening at one end of the covering membrane tube 40, so that the outer covering membrane 23 is fixedly connected outside the connecting portion 220, wherein the outside of the connecting portion 220 can be provided with radial protrusions, radial grooves or smooth arrangement, so that the container 200 and the intestinal stent 100 are connected. It will be appreciated that the proximal end of the outer cover 23 may also be looped with a flexible wireform 34, which prevents the container 200 and the intestinal stent 100 from slipping off due to the presence of the split ring 32.

As shown in fig. 24 and 25, in one embodiment, the proximal end of the outer covering film 23 is at least partially folded inward to form at least one inward folded portion 25, the inward folded portion 25 is located between the outer covering film 23 and the inner covering film 22, one or more portions of the inward folded portion 25 and the inner surface of the outer covering film 23 are connected by a flexible member, or/and one or more portions of the inward folded portion 25 and the inner covering film 22 are connected by a flexible member, so as to form a stable hooking structure at the proximal end of the outer covering film 23. In particular, the flexible member may be a linear member.

As further shown in fig. 26, in one embodiment, the connecting portion 220 of the container 200 is provided with an outer engaging portion 226 folded outward. When the intestinal stent 100 in fig. 24 is connected to the container 200 in the present embodiment, the proximal end of the outer covering film 23 is sleeved outside the connecting portion 220, and the outer locking portion 226 is inserted between the inward folded portion 25 and the outer covering film 23, so that the container 200 is locked to the proximal end of the outer covering film 23 by the outer locking portion 226 being inserted into the inward folded portion 25.

According to the intestinal tract stent 100 and the intestinal tract stent assembly 1 of the embodiment, the metal wave ring 11 is only arranged at one end of the coating film 20, one end of the coating film 20 provided with the metal wave ring 11 is inserted into the intestinal tract 300, so that the intestinal tract stent 100 is installed and positioned, the normal conduction process of the intestinal tract stent 100 to excrement in the intestinal tract 300 is ensured, meanwhile, no metal wave ring is arranged at the other end of the coating film 20, the other end of the coating film 20 can be arranged outside the intestinal tract 300, the length of the metal wave ring 11 in the intestinal tract 300 can be effectively reduced, the phenomenon that the intestinal tract 300 is perforated due to extrusion to the overlong intestinal tract wall caused by the length of the metal wave ring 11 of the intestinal tract stent 100 is reduced or avoided, and the use safety and reliability of the intestinal tract stent 100 are improved.

Further, by providing the cover film 20 as a double-layered structure of the inner cover film 22 and the outer cover film 23, inserting the inner cover film 22 into the connection port 221, and connecting the outer cover film 23 to the connection portion 220, it is possible to improve the sealing property when the intestinal stent 100 is connected to the container 200, prevent the occurrence of the leakage phenomenon, further improve the connection strength between the intestinal stent 100 and the container 200, and prevent the occurrence of the detachment phenomenon of the container 200 from the intestinal stent 100.

As shown in fig. 27, in one embodiment of the present application, the enteric stent assembly 1 has an enteric stent 100 and a receptacle (not shown in fig. 27). The intestinal stent 100 comprises a stent body 10, a covering membrane 20 and at least one radial contraction piece. The stent body 10 has a plurality of metal eyelets 11 arranged at intervals in the axial direction. The cover film 20 is a cylindrical structure with two open ends, the outer cover film 23 is arranged outside the inner cover film 22, the far end of the inner cover film 22 is connected with the outer cover film 23, the near end of the inner cover film 22 is arranged to exceed the near end of the outer cover film 23, the axial length of the outer cover film 23 is larger than that of the stent main body 10, and the stent main body 10 is arranged in the axial length range of the outer cover film 23 and is positioned at or close to the far end of the outer cover film 23. In this embodiment, at least one radial constriction element is connected to the outer covering membrane 23 or the stent body 10 and arranged along the axial direction of the outer covering membrane 23 or the stent body 10, and the proximal end of the at least one radial constriction element extends towards the proximal end of the intestinal stent 100, so that the operator can conveniently compress the metal wave ring 11 radially by compressing the radial constriction element in vitro.

In other embodiments, the stent graft 20 is the stent graft type of fig. 1, i.e., does not include the inner stent graft 22, in which the axial length of the stent graft 20 is greater than the axial length of the stent body 10, the stent body 10 is disposed within the axial length of the stent graft 20 at or near one end of the stent graft 20, and at least one radial constriction is connected to the stent graft 20 or the stent body 10 and disposed along the axial direction of the stent graft 20 or the stent body 10, the radial constriction being configured to radially compress the metallic wave ring 11.

It will be appreciated that when the radially contracting member is attached to the cover 20, the attachment point should be on the portion of the cover that contacts the stent body 10 so as to compress the radial dimension of the metallic spider 11.

When the intestinal stent assembly 1 of the present embodiment is used specifically, the intestinal stent 100 is implanted into the intestinal tract 300, the container is placed outside the body, and since one end of the container is closer to the operator, the end of the intestinal stent 100 provided with the metal wave ring 11 is defined as a distal end, and the other end (the end of the container) of the intestinal stent 100 opposite to the metal wave ring 11 is defined as a proximal end.

The structures and materials of the metal bellows 11 and the coating film 20 are the same as those of the related embodiments, and when the coating film 20 includes the inner coating film 22 and the outer coating film 23, they are also the same as those of the related embodiments, and are not described again.

The following is specific to the case where the cover film 20 includes an inner cover film 22 and an outer cover film 23. The radially contracting members in this embodiment are a plurality of rigid support rods 60 made of a material with good biocompatibility and good elasticity, such as nitinol or stainless steel. The plurality of support rods 60 are disposed around the outer coating film 23 and are respectively disposed along an axial direction of the outer coating film 23, and the plurality of support rods 60 are used for radially compressing the metal bellows 11. In another embodiment, a plurality of support rods 60 can be connected to the main body of the bracket by integral molding, welding, or gluing. The number of the supporting rods 60 may be one, and the supporting rods are compressed in the radial direction of the intestinal stent 100 during operation, so that the intestinal stent 100 can be compressed.

In the present embodiment, the radial constriction 60 comprises at least one of a straight line, a dogleg, or a curved line.

When the intestinal stent 100 needs to be taken out of the intestinal tract 300, the supporting rods 60 are compressed and furled in through the radial direction of the near end, the supporting rods 60 all move towards the inside of the intestinal stent 100, so that the metal wave ring 11 is driven to move along the radial direction of the metal wave ring 11, the radial size of the metal wave ring 11 is reduced, the metal wave ring 11 can be conveniently taken out of the intestinal tract 300, the phenomenon that the intestinal tract 300 is perforated due to long-term extrusion of the intestinal tract wall caused by the metal wave ring 11 of the intestinal stent 100 when the intestinal stent 100 is withdrawn is reduced or avoided, and the use safety and reliability of the intestinal stent 100 are improved. Meanwhile, the supporting rod 60 arranged axially has certain rigidity and supporting property, so that the intestinal tract stent 100 is not easy to accumulate and shorten in the sheath when released in the conveying device, thereby reducing the occurrence of clamping stagnation. In order to facilitate the operation of the support rod 60, the axial length of the support rod 60 in this embodiment is equal to or exceeds the axial length of the outer covering film 23, so that the operator can withdraw the intestinal stent 100 from the body through the proximal end of the support rod.

In this embodiment, the connection mode and the connection structure of the intestinal stent 100 and the container 200 can refer to all the above embodiments, and are not described herein again.

Further, as shown in fig. 28, in one embodiment, the intestinal stent 100 further includes a plurality of recovery strings 601, the recovery strings 601 are connected to the outer cover 23 or any of the metal eyelets 11, and a plurality of support rods 60 are annularly provided in an axial range of the outer cover 23 corresponding to the plurality of metal eyelets 11. The recovery cord 601 in this embodiment is a flexible member, and is made of PET or PP. When the intestinal stent 100 needs to be withdrawn from the intestinal tract 300, the supporting rod 60 can radially compress the metal wave rings 11, and the recovering rope 601 is pulled towards the proximal end, so that the recovering rope 601 drives the metal wave rings 11 to be withdrawn towards the proximal end of the intestinal stent 100, and finally all the metal wave rings 11 are smoothly withdrawn one by one and withdrawn out of the body.

Since the metal wave ring 11 is directly operated by the recovery rope 601 in this embodiment, the metal wave ring 11 does not need to be driven by the support rod 60 to move towards the proximal end.

As shown in fig. 29 to 31, in one embodiment, the radial constriction element includes an axial sleeve 62 and a constriction rod 63, the axial sleeve 62 is disposed along the axial direction of the outer covering film 23, the axial sleeve 62 is disposed away from the one end opening of the stent main body 10, and the constriction rod 63 is inserted into the axial sleeve 62 through the one end opening of the stent main body 10. The contraction rod 63 in this embodiment is made of a material having a certain supporting function, such as POM, stainless steel, or the like. The surface of the contraction rod 63 is smooth, and the end of the contraction rod 63 inserted into the axial sleeve 62 is smooth, thereby facilitating smooth insertion of the contraction rod 63 into the axial sleeve 62. The number of the axial sleeves 62 may be designed to be one or more, and a plurality of axial sleeves 62 are provided on the outer cover film 23 at intervals in the circumferential direction of the outer cover film 23.

Axial cover 62 and shrink pole 63 among this embodiment are detachable structure to can dismantle shrink pole 63 in the transportation of intestinal support 100, thereby be convenient for intestinal support 100 to compress in transportation. When the intestinal stent 100 needs to be removed from the intestinal tract 300, the contraction rod 63 is inserted into the axial sleeve 62, and the contraction rod 63 is moved toward the center direction of the intestinal stent 100 by radially compressing the contraction rod 63, so that the radial dimension of the stent body 10 is reduced, and the intestinal stent 100 is convenient to be removed from the intestinal tract 300.

Further, as shown in fig. 30, the axial sheath 62 of the present embodiment has at least one bending section 621, when the contraction rod 63 is inserted into the axial sheath 62, because the contraction rod 63 has rigidity, the bending section 621 is straightened, so that the intestinal stent 100 is radially compressed, and the intestinal stent 100 is conveniently withdrawn. Meanwhile, the arrangement of the bending section 621 can increase the friction force between the axial sleeve 62 and the telescopic rod 63, so as to prevent the telescopic rod 63 from sliding off from the axial sleeve 62 in the process of withdrawing the intestinal stent 100, and further improve the safety and reliability of the use of the intestinal stent 100.

With reference to fig. 32 and 33, in an embodiment, the radial contraction member includes a film cover 64 and a contraction string 61, the film cover 64 includes an annular portion 641 and an axial portion 642, the annular portion 641 and the axial portion 642 are both hollow tubular structures, the annular portion 641 is annularly disposed on the outer film 23 and corresponds to the metal wave ring 11, the axial portion 642 is disposed along an axial direction of the outer film 23 and is communicated with the annular portion 641, a part of the contraction string 61 is annularly disposed inside the annular portion 641, and two ends of the contraction string 61 extend out of the film cover 64 through an opening at one end of the axial portion 642. Specifically, one end of the contraction string 61 is held stationary, and the other end of the contraction string 61 penetrates into the cover 64, passes through the axial portion 642 and the annular portion 641, and then passes out of the cover 64 from the axial portion 642. The cover 64 and the outer cover 23 of the intestinal stent 100 are connected together, and can be integrally formed or connected subsequently. The cover film 64 may be made of ePTFE (expanded polytetrafluoroethylene), PTFE (tetrafluoroethylene), PET (polyester resin) or PE (polyethylene).

In this embodiment, the number of the axial portions 642 is one, and both ends of the contraction string 61 extend out of the film cover 64 from the opening of the same axial portion 642. When the intestinal stent 100 needs to be withdrawn from the intestinal tract 300, the two ends of the contraction rope 61 are pulled at the same time, so that the annular part 641 is contracted and deformed radially, and the metal wave ring 11 is driven to contract and deform radially, thereby facilitating the withdrawal of the intestinal stent 100 from the intestinal tract 300. Further, in the present embodiment, the number of the coating covers 64 is plural, and the annular portions 641 of the plural coating covers 64 are provided in one-to-one correspondence with the plural metal bellows 11. In another embodiment, the film cover 64 may also include two axial portions 642 and an annular portion 641 connected between the two axial portions 642, and accordingly, the annular portion 641 is provided with an opening, the two axial portions 642 are respectively communicated with two ends of the opening, and two ends of the contraction string 61 respectively extend out of the two axial portions 642 to the outside of the film cover 64.

Further, as shown in fig. 34, in an embodiment, the radial constriction may further include a constriction tube 643, and the constriction tube 643 is a hollow tubular structure and is inserted into the axial portion 642 until one end of the constriction tube 643 abuts against the annular portion 641 and communicates with the annular portion 641. With one end of the retraction cord 61 held stationary, the other end of the retraction cord 61 passes into the retraction tube 643, through the loop 641, through the retraction tube 643, and out through the cover 64 and the retraction tube 643. The shrink tube 643 in this embodiment is a hollow tubular structure with both ends open, and has a certain supporting function, and the material may be selected from stainless steel, POM, or the like. By arranging the contraction tube 643 in the axial portion 642, the axial compression deformation of the axial portion 642 can be avoided in the process of pulling the contraction rope 61, so that the normal pulling process of the contraction rope 61 is ensured, the axial movement of the metal wave ring 11 is avoided, the metal wave ring 11 can be radially compressed in situ, and the damage of the metal wave ring 11 to intestinal tissues is reduced.

According to the intestinal stent 100, the metal wave ring 11 is arranged at only one end of the coating film 20, and one end of the coating film 20 provided with the metal wave ring 11 is inserted into the intestinal tract, so that the intestinal stent 100 is installed and positioned, the normal conduction process of the intestinal stent 100 to the excrement in the intestinal tract 300 is ensured, meanwhile, no metal wave ring is arranged at the other end of the coating film 20, the other end of the coating film 20 can be arranged outside the intestinal tract 300, the length of the metal wave ring 11 in the intestinal tract 300 can be effectively reduced, the phenomenon that the intestinal tract 300 is perforated due to extrusion to the intestinal tract wall caused by overlong length of the metal wave ring 11 of the intestinal stent 100 is reduced or avoided, and the safety and the reliability of the use of the intestinal stent 100 are improved. When the intestinal stent 100 needs to be taken out from the intestinal tract 300, the radial contraction part is pressed along the radial direction, so that the radial contraction part moves towards the center direction of the metal wave ring 11, the radial size of the metal wave ring 11 is reduced, the metal wave ring 11 is convenient to take out from the intestinal tract 300, the intestinal perforation phenomenon caused by long-term extrusion of the metal wave ring 11 of the intestinal stent 100 on the intestinal tract wall is reduced or avoided, and the use safety and reliability of the intestinal stent 100 are improved.

While the invention has been described with reference to specific preferred embodiments, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention as defined in the following claims. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. An intestinal stent, comprising:

a stent body comprising at least one metallic undulating ring;

the tectorial membrane, the tectorial membrane is located the surface of support main part, the tectorial membrane includes interior tectorial membrane and outer tectorial membrane, outer tectorial membrane is located the outside of interior tectorial membrane, the distal end of interior tectorial membrane with outer tectorial membrane links to each other, the near-end of interior tectorial membrane surpasss the near-end of outer tectorial membrane, the axial length of outer tectorial membrane is greater than the axial length of support main part, support main part is located the axial length within range of outer tectorial membrane is located or is close to the distal end of outer tectorial membrane.

2. The intestinal stent of claim 1, further comprising a fixed connector disposed at or near the proximal end of the outer covering membrane.

3. The intestinal stent of claim 2, wherein the outer covering membrane and the inner covering membrane have an overlapping area, a plurality of connecting holes are arranged on the outer covering membrane in the overlapping area, and the fixing connecting pieces are arranged in the connecting holes in a penetrating way.

4. The enteric stent of claim 2, wherein the fixed connector is a flexible wirelike structure or an elastic loop.

5. The intestinal stent according to claim 2, further comprising a covering tube, wherein the covering tube is a tubular structure with two open ends, the covering tube is annularly arranged at the proximal end of the outer covering film or at a position close to the proximal end, the two open ends of the covering tube are spaced and oppositely arranged, the fixed connecting piece comprises an annular structure with a notch, and the fixed connecting piece can be inserted into the interior of the covering tube through the opening at one end of the covering tube.

6. The intestinal stent according to claim 1, wherein the proximal end of the outer covering membrane is at least partially folded inwards to form at least one inwards folded part, the inwards folded part is positioned between the outer covering membrane and the inner covering membrane, and the inwards folded part is connected with the outer covering membrane or/and the inner covering membrane.

7. An intestinal tract bracket component, which is characterized in that the intestinal tract bracket component comprises the intestinal tract bracket according to claim 1, and further comprises a container, wherein the container comprises a cavity part and a connecting part, a containing cavity is arranged inside the cavity part, the connecting part is provided with a connecting port communicated with the containing cavity, the near end of the inner covering film can be inserted into the connecting port, and the near end of the outer covering film is positioned outside the connecting part.

8. The intestinal stent assembly according to claim 7, wherein the outer covering membrane is provided with a plurality of connecting holes, the connecting portion is provided with a plurality of mounting holes, and the mounting holes are connected with the connecting holes through fixed connecting pieces.

9. The intestinal stent assembly according to claim 7, wherein the connecting portion has a radial protrusion, the proximal end of the outer covering membrane is sleeved outside the radial protrusion, and a fixed connector is disposed at or near the proximal end of the outer covering membrane and connects the outer covering membrane and the radial protrusion; or, the connecting part is provided with a radial groove, the near end of the outer coating film is sleeved outside the radial groove, a part of the outer coating film, which corresponds to the radial groove, is provided with a fixed connecting piece, and the fixed connecting piece is connected with the outer coating film and the radial groove.

10. The intestinal stent assembly of claim 7, wherein the connecting portion is provided with an outwardly folded outer clamping portion, the proximal end of the outer covering membrane is provided with an inwardly folded portion, and the outer clamping portion is inserted between the inwardly folded portion and the outer covering membrane.