WO2020238167A1

WO2020238167A1 - Tissue drainage stent

Info

Publication number: WO2020238167A1
Application number: PCT/CN2019/126069
Authority: WO
Inventors: 孙亿民; 李玉茜; 冷德嵘; 潘长网; 李常青; 李宁; 奚杰峰; 韦建宇
Original assignee: 南微医学科技股份有限公司
Priority date: 2019-05-24
Filing date: 2019-12-17
Publication date: 2020-12-03
Also published as: ES1285656U; ES1285656Y; DE212019000425U1; CN210277940U

Abstract

The present application relates to the technical field of minimally invasive medical devices, in particular, to a tissue drainage stent. The tissue drainage stent comprises a drainage tube and a first flange provided at one end of the drainage tube, the first flange protrudes from the outer wall of the drainage tube, and the drainage tube is hollow to form a drainage channel; the end of the drainage tube corresponding to target tissue is provided with the first flange that can be expanded outward, the first flange comprises a plurality of first supporting wings that expand outward, the first supporting wings can support a wall surface of the target tissue to prevent the wall surface of the target tissue from blocking the connection part between the drainage tube and the target tissue due to contact during a drainage process, thereby ensuring the smoothness of inter-tissue drainage and improving the treatment effect; moreover, the plurality of first supporting wings jointly support the wall surface of the tissue so that the wall surface is evenly stressed, thereby reducing irritation to the tissue.

Description

Tissue drainage stent

Cross references to related applications

This application claims the priority of the Chinese patent application with the application number 201920766219.0 and the name "Tissue Drainage Stent" filed with the Chinese Patent Office on May 24, 2019, the entire content of which is incorporated into this application by reference.

Technical field

This application relates to the technical field of minimally invasive medical devices, in particular to a tissue drainage stent.

Background technique

With the development of endoscopy and ultrasound endoscopy, the technology of inserting metal stents for interstitial anastomoses and drainage under endoscopy has been correspondingly developed, such as pancreatic cyst drainage, gastrojejunostomy, and gallbladder stone removal. At present, there are anastomotic drainage stents on the market. When using this stent for drainage of pancreatic pseudocyst, for example, if the cyst becomes smaller, the cyst walls will be close to each other, and the cyst wall that comes close will cover the end of the stent. The part leads to poor subsequent drainage and hinders further drainage; and the tip of the end surface of the stent will even stimulate the wall of the cyst that is close to it, and excessive stimulation will cause continuous inflammation or bleeding on the wall of the cyst that is close to it.

Therefore, there is an urgent need to provide an anastomotic drainage stent with sufficient drainage effect and less tissue irritation.

Summary of the invention

The purpose of the present application is to provide a tissue drainage stent to solve to a certain extent the technical problem of poor drainage of the tissue drainage stent in the prior art and greater stimulation to the tissue wall surface.

The present application provides a tissue drainage stent, which includes a drainage tube and a first flange arranged at one end of the drainage tube;

The first flange includes a plurality of first supporting wings; one end of the first supporting wing is connected to the drainage tube, and the other end extends in a direction away from the centerline of the drainage tube; and a plurality of the first supporting wings The supporting wings are arranged along the circumference of the drainage tube.

Further, the first supporting wing has a flat sheet shape or a curled sheet shape.

Further, the number of the first support wings is three, the three first support wings are arranged at equal intervals along the circumference of the drainage tube, and the three first support wings are opposite to the drainage tube. The center line is distributed in rotational symmetry.

Further, the corners of one end of the first supporting wing away from the drainage tube present an arc transition.

Further, a second flange is provided on the end of the drainage tube away from the first flange;

The second flange has a continuous flanging curl structure or a bulging spherical structure along the circumferential direction of the drainage tube; or,

The second flange includes a plurality of second supporting wings; one end of the second supporting wing is connected with the drainage tube, and the other end extends in a direction away from the centerline of the drainage tube; and a plurality of the second supporting wings The supporting wings are arranged along the circumference of the drainage tube.

Further, the second supporting wing has a flat sheet shape, a curled sheet shape or a convex spherical shape.

Further, the extension length of the first flange and the second flange in the radial direction of the drainage tube is 0.3-2 times the outer diameter of the drainage tube.

Further, at least part of the first supporting wing and at least part of the second supporting wing are provided with an X-ray developer.

Further, a recovery line is provided on the second flange.

Further, the drainage tube, the first flange, and the second flange are all silk-like woven structures, and are all covered with a biological leakproof membrane.

Compared with the prior art, the beneficial effects of this application are:

The tissue drainage stent of the present application is configured to be inserted into the body under an endoscope to perform an anastomosis and drainage between tissues. The drainage tube is hollow to form a drainage lumen, one end of which is connected to the target tissue, and the other end is connected to the anastomotic tissue. Drainage between the organization and the anastomosing organization. Since the target tissue (such as pancreatic pseudocyst) decreases during the drainage process, the cyst wall may fit and block the connection between the drainage tube and the target tissue, resulting in poor drainage between the tissues. Therefore, in the present application, one end of the drainage tube corresponding to the target tissue is provided with a first flange that can be expanded outward. The first flange includes a plurality of first support wings that are expanded outward, and the first support wings can affect the target tissue. The wall is supported to prevent the wall of the target tissue from sticking to block the connection between the drainage tube and the target tissue during the drainage process, thereby ensuring the smooth drainage between the tissues and improving the treatment effect; at the same time, multiple first supporting wings are shared Supporting the tissue wall can make the wall face uniform force and reduce the irritation to the tissue.

Description of the drawings

In order to more clearly illustrate the specific embodiments of this application or the technical solutions in the prior art, the following will briefly introduce the drawings that need to be used in the specific embodiments or the description of the prior art. Obviously, the appendix in the following description The drawings are some embodiments of the application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work.

FIG. 1 is a schematic structural diagram of a tissue drainage stent provided by an embodiment of the application;

2 is a schematic structural diagram of the first flange of the tissue drainage stent provided by an embodiment of the application;

FIG. 3 is a schematic diagram of another structure of the first flange of the tissue drainage stent provided by an embodiment of the application;

FIG. 4 is a schematic diagram of another structure of the first flange of the tissue drainage stent provided by an embodiment of the application;

FIG. 5 is another structural schematic diagram of the first flange of the tissue drainage stent provided by the embodiment of the application;

FIG. 6 is another structural schematic diagram of the first flange and the second flange of the tissue drainage stent provided by the embodiment of the application;

FIG. 7 is another structural schematic diagram of the first flange and the second flange of the tissue drainage stent provided by the embodiment of the application;

Figure 8 is a schematic top view of the structure of a tissue drainage stent provided in Figure 6;

Figure 9 is a schematic top view of the structure of the tissue drainage stent provided in Figure 7;

FIG. 10 is a schematic top view of another structure of the tissue drainage stent provided by an embodiment of the application;

11 is a schematic top view of another structure of the tissue drainage stent provided by the embodiment of the application;

Figure 12 is a schematic side view of another structure of the tissue drainage stent provided by an embodiment of the application;

FIG. 13 is a schematic diagram of another structure of a tissue drainage stent provided by an embodiment of the application.

Reference signs:

1- drainage tube, 2- first flange, 201- first support wing, 3- second flange, 301- second support wing, 4- recovery line.

Detailed ways

The technical solutions of the present application will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments.

The components of the embodiments of the present application generally described and shown in the drawings herein may be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely represents selected embodiments of the present application.

Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of this application.

In the description of this application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner" and "outer", etc. The indicated orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the application and simplifying the description, and does not indicate or imply that the pointed device or element must have a specific orientation or be in a specific orientation. The azimuth structure and operation cannot be understood as a limitation of the application. In addition, the terms "first", "second" and "third" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance.

In the description of this application, it should be noted that the terms "installation", "connection" and "connection" should be understood in a broad sense, unless otherwise clearly specified and limited. For example, they can be fixed or detachable. Connected or integrally connected; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication between two components. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.

The following describes tissue drainage stents according to some embodiments of the present application with reference to FIGS. 1 to 13.

1 to 11, an embodiment of the present application provides a tissue drainage stent, including a drainage tube 1 and a first flange 2 provided at one end of the drainage tube 1, the first flange 2 protruding from the drainage tube 1 The outer wall. The first flange 2 includes a plurality of first supporting wings 201; one end of the first supporting wings 201 is connected to the drainage tube 1, and the other end extends outward in a direction away from the center line of the drainage tube 1; and a plurality of first supporting wings 201 It is arranged along the circumferential direction of the drainage tube 1, that is, the plurality of first supporting wings 201 can be expanded outward to form an open structure and form a supporting surface to support the target tissue.

Specifically, the tissue drainage stent of the embodiment of the present application is configured to be inserted into the body under an endoscope to perform an anastomosis and drainage between tissues, wherein the drainage tube 1 is hollow to form a drainage channel, one end of which is connected to the target tissue, and the other end is connected to the anastomosing tissue Connected to drain between the target tissue and the anastomosing tissue. Since the target tissue (such as a pancreatic pseudocyst) is reduced during the drainage process, the cyst wall may fit and block the connection between the drainage tube 1 and the target tissue, resulting in poor drainage. For this reason, the present application A first flange 2 that can be expanded outward is provided at one end of the drainage tube 1 corresponding to the target tissue. The first flange 2 includes a plurality of first supporting wings 201 that are expanded outward. To prevent the wall surface of the target tissue from sticking to block the connection between the drainage tube 1 and the target tissue during the drainage process, so as to ensure the smooth drainage between the tissues and improve the treatment effect; at the same time, multiple first supports The wings 201 jointly support the tissue wall surface to make the wall surface uniformly stressed and reduce the irritation to the tissue.

In addition, in order to improve the stability of the support of the first flange 2 to the target tissue, referring to FIGS. 2 to 5, the plurality of first support wings 201 provided in the embodiment of the present application may be deployed in an umbrella shape or a petal shape. Or it is deployed like a wind wheel to support the wall surface of the target tissue around the outer circumference of the drainage tube 1 to ensure the normal drainage of the drainage tube. Preferably, as shown in Figures 2 and 3, when the plurality of first supporting wings 201 can be deployed in an umbrella shape, the clinical needs can be adjusted by adjusting the number of knitting heads or the outermost outer diameter of the umbrella end of the first supporting wings 201 The supporting force of the first flange 2 to ensure the normal drainage.

It should be noted that, in order to avoid the unfolded first supporting wing 201 from causing irritation to the target tissue, the first supporting wing 201 in the embodiment of the present application has no sharp corners and can have a good fit with the wall surface of the target tissue. Causes irritation to the tissue wall, causing inflammation or bleeding. In addition, the first supporting wing 201 has a certain degree of flexibility to reduce irritation to the tissue wall.

Therefore, the tissue drainage stent of the present application can have a long-lasting drainage effect in the process of inter-tissue drainage treatment, and has little tissue irritation.

In an embodiment of the present application, preferably, referring to FIGS. 2 to 11, the first supporting wing 201 is in the shape of a flat sheet or a rolled sheet.

When the first supporting wing 201 is in the shape of a flat sheet, it extends along the radial direction of the drainage tube 1, and can be umbrella-shaped (as shown in Figures 2 and 3), petal-shaped (as shown in Figure 4) or wind Wheel type (as shown in Figure 5) and so on. When the first supporting wing 201 is in the shape of a curled sheet, its curling direction can be along the radial direction of the drainage tube 1 (as shown in Figures 6 and 7) or along the outer circumference of the drainage tube 1 (not shown in the figure) . Preferably, when the first supporting wing 201 is curled along the radial or outer circumferential direction of the drainage tube 1, its opening direction faces the target tissue. Therefore, the first supporting wing 201 can form an interstitial fluid circulation inlet with the target tissue to promote the drainage of interstitial fluid ; At the same time, the unique open structure at the inlet end will not form a fully enclosed cavity when the drainage tissue (such as a pancreatic cyst) shrinks, and has the function of guiding fluid into the drainage tube.

In addition, it should be noted that when the first flange 2 is in an umbrella shape, a petal shape or a wind wheel shape, the first supporting wing 201 is preferably a flat sheet, and the plurality of flat sheet-shaped first supporting wings 201 may be spaced apart from each other. Set up or stack up to present a complete supporting surface. When the first supporting wing 201 is in the shape of a curled sheet, the number of the first supporting wing 201 may be relatively small, preferably two or four.

In an embodiment of the present application, preferably, referring to FIG. 4, the number of the first supporting wings 201 is three, and the three first supporting wings 201 are arranged at equal intervals along the circumferential direction of the drainage tube 1, and three The first supporting wings 201 are distributed in a rotationally symmetrical manner with respect to the centerline of the drainage tube 1 and present a wind wheel-like structure. The three first supporting wings 201 are arranged at equal intervals to effectively support the wall surface of the target tissue, and achieve the optimal supporting effect when the number of supporting wings is the smallest.

In an embodiment of the present application, preferably, referring to FIG. 7, the corners of the end of the first supporting wing 201 away from the drainage tube 1 are in an arc-shaped transition.

In this embodiment, in order to further improve the adhesion of the first supporting wing 201 to the wall surface of the target tissue, and to prevent the first supporting wing 201 from causing irritation to the wall surface of the target tissue, the first supporting wing 201 is arranged away from the drainage tube 1 in this embodiment. The corners of one end are in an arc transition, that is, the expanded edge of the first support wing 201 is in an arc transition, without sharp corners or edges, so as to avoid irritation to the wall of the target tissue, and overcome the existing inter-tissue metal to a certain extent. Drainage stents can easily cause inflammation, bleeding or hyperplasia and other defects in tissue stimulation.

In an embodiment of the present application, preferably, as shown in Figs. 1, 6, 7, 12 and 13, a second flange 3 is provided on the end of the drainage tube 1 away from the first flange 2;

The second flange 3 has a continuous flanging curled structure or a bulging spherical structure along the circumferential direction of the drainage tube 1 (as shown in Figure 12); or,

The second flange 3 includes a plurality of second supporting wings 301; one end of the second supporting wings 301 is connected to the drainage tube 1, and the other end extends outward in a direction away from the centerline of the drainage tube 1; and a plurality of second supporting wings 301 It is arranged along the circumference of the drainage tube 1.

In this embodiment, the end of the drainage tube 1 away from the first flange 2, that is, the end close to the anastomotic tissue is provided with a second flange 3 protruding outwards, and the second flange 3 is supported and fixed with the anastomotic tissue. On the one hand, the second flange 3 can prop up the wall of the anastomotic tissue to prevent the anastomotic tissue from blocking the drainage channel, and further ensure the smooth outflow of the drainage material; on the other hand, the anastomotic tissue can drain the whole through the second flange 3 The stent plays a fixed role and prevents the drainage stent from falling off into the abdominal cavity.

Regarding the specific structure of the second flange 3, it can be a continuous flanging curled structure or an expanded spherical structure along the circumference of the drainage tube 1, or it can be in the form of a supporting wing like the first flange 2, as long as it can It is sufficient to support drainage of the anastomotic tissue and fix the entire stent.

It should be noted that, as shown in FIG. 12, when the second flange 3 has a continuous bulging spherical structure along the circumferential direction of the drainage tube 1, it presents a mushroom-like flat umbrella structure, and its bulging wall is smooth. And it protrudes from one end of the drainage tube 1, and at the same time, its bulging wall is provided with an opening corresponding to the open end of the drainage tube 1, forming an inlet end.

In an embodiment of the present application, preferably, as shown in FIG. 1, FIG. 6, FIG. 7 and FIG. 13, the second supporting wing 301 is in the shape of a flat sheet, a curled sheet or a convex spherical shape.

In this embodiment, when the second flange 3 adopts the form of an outwardly expanded supporting wing, the specific structure of the second supporting wing 301 can be a flat sheet (as shown in FIG. 1) or a rolled sheet (as shown in FIG. 6 and Fig. 7), it can also be a convex spherical shape bulging outwards (as shown in Fig. 13). When the second supporting wing 301 is in the shape of a flat sheet or a rolled sheet, its structure and arrangement principle are the same as those of the first supporting wing 201, so it is not repeated here. In addition, the second supporting wing 301 can also adopt a convex spherical shape that bulges outwards, because the anastomotic tissue end does not require an excessively large supporting area, so as long as the second flange 3 can support the wall of the anastomotic tissue to avoid blocking the drainage The cavity can be used to fix the stent at the same time; the convex spherical support wings have better surface smoothness and are not easy to cause irritation to the tissue.

In an embodiment of the present application, preferably, referring to FIG. 12 and FIG. 13, in order to ensure that the first flange 2 and the second flange 3 have a certain supporting area to support the corresponding tissue Function to prevent the tissue from blocking the drainage channel and obstructing drainage. In the embodiment of the present application, the first flange 2 and the second flange 3 are set to 0.3- of the outer diameter of the drainage tube 1 along the radial extension of the drainage tube 1. 2 times, that is, the outer diameter D1 of the first flange 2 and the outer diameter D2 of the second flange 3 are respectively more than 1.3 times the outer diameter D of the drainage tube 1, and preferably the first flange 2 and the second flange The outer diameters of 3 are respectively within 3 times of the outer diameter D of the drainage tube 1, to ensure that the overall size of the drainage stent is within a reasonable range, and to ensure more adequate drainage of the tissue fluid.

In an embodiment of the present application, preferably, in order to understand the support and positioning of the drainage stent in the body during X-ray imaging detection, in the embodiment of the present application, at least part of the first support wing 201 and at least part of the second support wing An X-ray developer is provided on the 301. Further preferably, an X-ray developer can be provided on each first support wing 201 of the first flange 2 and each second support wing 301 of the second flange 3 correspondingly. The material of the X-ray developer can be tantalum.

In an embodiment of the present application, preferably, referring to Figures 1, 12 and 13, in order to facilitate the removal of the drainage support at the end of the drainage, the embodiment of the present application is provided with a recovery on the second flange 3. Line 4, pull the recovery line 4 to take out the drainage support. Preferably, the recovery line 4 is arranged at the edge of the second flange 3.

In addition, the material of the recycling line 4 can be selected from high molecular polymers or metal wires that have good biocompatibility and are not easily corroded by body fluids.

In an embodiment of the present application, preferably, the drainage tube 1, the first flange 2 and the second flange 3 are all wire-like braided structures, specifically braided by memory alloy wires. In addition, the drainage tube 1, the first flange 2 and the second flange 3 are all covered with a bio-leakage membrane to prevent the drainage material from leaking from the stent mesh, and can effectively inhibit the growth of the tissue wall into the stent mesh in contact with it In the hole, prevent the in-grown granulation.

Preferably, the material of the biological leak-proof membrane may be a polymer material with good biological properties such as PTFE, PET, or silica gel, which will not cause biological toxicity and can facilitate the later recovery of the stent.

Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the application, not to limit them; although the application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand: It is still possible to modify the technical solutions described in the foregoing embodiments, or equivalently replace some or all of the technical features; these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the technical solutions of the embodiments of the application range.

Claims

A tissue drainage stent, which is characterized by comprising a drainage tube and a first flange arranged at one end of the drainage tube;

The first flange includes a plurality of first supporting wings; one end of the first supporting wing is connected to the drainage tube, and the other end extends in a direction away from the centerline of the drainage tube; and a plurality of the first supporting wings The supporting wings are arranged along the circumference of the drainage tube.
The tissue drainage stent according to claim 1, wherein the first supporting wing is in the shape of a flat sheet or a curled sheet.
The tissue drainage stent according to claim 1, wherein the number of the first support wings is three, and the three first support wings are arranged at equal intervals along the circumference of the drainage tube, and three The first supporting wings are distributed rotationally symmetrically with respect to the centerline of the drainage tube.
The tissue drainage stent according to claim 1, wherein the corners of one end of the first supporting wing away from the drainage tube are in an arc transition.
The tissue drainage stent according to any one of claims 1 to 4, wherein a second flange is provided on the end of the drainage tube away from the first flange;

The second flange has a continuous flanging curl structure or a bulging spherical structure along the circumferential direction of the drainage tube; or,

The second flange includes a plurality of second supporting wings; one end of the second supporting wing is connected with the drainage tube, and the other end extends in a direction away from the centerline of the drainage tube; and a plurality of the second supporting wings The supporting wings are arranged along the circumference of the drainage tube.
The tissue drainage stent according to claim 5, wherein the second supporting wing has a flat sheet shape, a curled sheet shape or a convex spherical shape.
The tissue drainage stent according to claim 5, wherein the radial extension length of the first flange and the second flange along the drainage tube is 0.3-2 of the outer diameter of the drainage tube Times.
The tissue drainage stent according to claim 5, wherein at least part of the first supporting wing and at least part of the second supporting wing are provided with an X-ray imaging member.
The tissue drainage stent according to claim 5, wherein a recovery line is provided on the second flange.
The tissue drainage stent according to claim 5, wherein the drainage tube, the first flange and the second flange are all silk-like braided structures, and are all covered with a biological leak-proof membrane.