CN114403968A

CN114403968A - Intracavity occluder and processing method thereof

Info

Publication number: CN114403968A
Application number: CN202111667679.6A
Authority: CN
Inventors: 李安伟; 汤凯丽; 王永胜
Original assignee: Hangzhou Wei Qiang Medical Technology Co ltd
Current assignee: Hangzhou Wei Qiang Medical Technology Co ltd
Priority date: 2021-12-30
Filing date: 2021-12-30
Publication date: 2022-04-29
Anticipated expiration: 2041-12-30
Also published as: CN114403968B

Abstract

The application provides an intracavity occluder and a processing method thereof, wherein the intracavity occluder comprises a bracket, a flow blocking membrane and a plug promoting piece; the bracket is of a hollow structure and comprises two end faces and a side face connected between the two end faces, and the side face of the bracket is a concave-convex surface or a cylindrical surface; the flow resisting film is arranged on the inner periphery of the bracket and comprises two end faces and a side face connected between the two end faces, and the side face of the flow resisting film is a concave-convex surface or a cylindrical surface matched with the side face of the bracket; the plug piece is arranged between the side surface of the flow-resisting film and the side surface of the bracket. Through the design, the support can be used for accommodating the flow blocking film in a large space inside the support, and the flexibility of the support cannot be influenced by the arrangement of the flow blocking film. In addition, in the conveying process, the stent can be contracted in the sheath, so that the plug piece arranged between the stent and the flow blocking membrane cannot be broken due to direct contact with the sheath, and the stent can be plugged into the sheath easily.

Description

Intracavity occluder and processing method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to an intracavity occluder and a processing method thereof.

Background

The mode of treating the aortic dissection in the market at present is mainly thoracic aortic endoluminal repair, but the endoluminal repair can only block the proximal lacerations of the dissection, and the existence of the distal lacerations can lead to the continuous blood perfusion of the false lumen, thereby leading to the continuous expansion of the false lumen. One of the current treatment modalities for distal lacerations is the technique of pseudoluminal embolization, which blocks blood flow within the pseudolumen.

The false lumen embolization technique (embolization) is to fill a spring ring, an embolization agent, a special embolization device and the like in a sandwiched false lumen to slow down or block the blood flow in the false lumen, promote the formation of the thrombus in the false lumen, and achieve the purposes of preventing the expansion of the false lumen and promoting the reconstruction of the aorta. The common embolism devices comprise spring rings, biological glue, an embolic agent, Candy plugs (Candy-plug) and the like, and for the condition that a false cavity is large and a plurality of crevasses exist, a plurality of spring rings need to be filled, so that the operation difficulty is high, the filling effect is poor, and the false cavity is easily flushed out from other crevasses by blood flow; the Candy plug (Candy-plug) has the same principle as the spring ring plug, and a blind end film-covered stent similar to Candy is placed into a false cavity through a false cavity breach to reduce the blood flow of the false cavity; the above embolization devices block the blood flow in the dummy lumen by filling the dummy lumen, and thus promote the embolization, and none of them has a portion capable of accelerating the embolization, and the embolization in the dummy lumen can not be achieved in a short time.

Disclosure of Invention

It is a primary object of the present application to overcome at least one of the above-mentioned deficiencies of the prior art and to provide an endoluminal closure device with both good thrombogenic function and better compliance of the stent.

It is another primary object of the present application to overcome at least one of the above-mentioned deficiencies of the prior art and to provide a method of manufacturing an endoluminal closure device.

In order to achieve the purpose, the following technical scheme is adopted in the application:

according to one aspect of the present application, there is provided an intraluminal occluding device comprising a stent, a flow blocking membrane, and an embolic element; the bracket is of a hollow structure and comprises two end faces and a side face connected between the two end faces, and the side face of the bracket is a concave-convex surface or a cylindrical surface; the flow resisting film is arranged on the inner periphery of the bracket and comprises two end faces and a side face connected between the two end faces, and the side face of the flow resisting film is a concave-convex surface or a cylindrical surface matched with the side face of the bracket; the plug member is disposed between a side of the flow blocking membrane and a side of the stent.

According to one embodiment of the present application, the intraluminal occluding device comprises a plurality of said embolic elements, positioned to correspond to the convex and/or concave portions of the concave-convex surface, respectively.

According to one embodiment of the present application, the tether is a membrane structure wrapped around the inner circumference of the stent.

According to one embodiment of the application, the plug is locally co-attached to the side of the flow-blocking membrane and to the side of the stent, the attachment paths being located in the convex and/or concave portions of the concave-convex surface.

According to one embodiment of the present application, the material of the embolic element comprises a PET film, a sponge, a foam, a gauze or a hydrogel.

According to one embodiment of the present application, the side surface of the flow blocking film is partially connected to the side surface of the stent, and the connection path is located at a convex portion and/or a concave portion of the concave-convex surface.

According to one embodiment of the present application, a connection path between the side surface of the flow blocking film and the side surface of the stent has a closed loop shape along the circumferential direction of the stent.

According to one embodiment of the present application, an end surface of the flow blocking film is partially connected to an end surface of the stent, and a connection path has a closed loop shape having a size smaller than an inner diameter of the stent and concentric with the stent.

According to one embodiment of the present application, a connection path between at least one end face of the current-blocking film and a corresponding end face of the stent includes at least two closed figures, and the at least two closed figures are concentric and are different in size.

According to another aspect of the present application, there is provided a method of manufacturing an intraluminal occluder, comprising: providing a support, wherein the support is of a hollow structure and comprises two end faces and a side face connected between the two end faces, and the side face of the support is a concave-convex surface or a cylindrical surface; arranging a flow resistance film on the inner periphery of the bracket, wherein the flow resistance film comprises two end faces and a side face connected between the two end faces, and the side face of the flow resistance film is a concave-convex surface or a cylindrical surface matched with the side face of the bracket; and arranging an embolism piece between the side surface of the flow-resisting membrane and the side surface of the bracket or on the periphery of the side surface of the bracket.

According to one embodiment of the present application, the material of the tether comprises a PET film, and the step of disposing the tether comprises: cutting the PET film to a length equal to the circumference of the support; stretching the PET film in a length direction and/or a width direction; and arranging the PET film between the side surface of the flow resistance film and the side surface of the bracket or on the periphery of the side surface of the bracket.

According to one embodiment of the present application, the material of the embolic element comprises a hydrogel, and the step of disposing the embolic element comprises: pouring the solution containing the hydrogel and the scaffold into a mold and standing at a constant temperature, so that the hydrogel is attached to the surface of the scaffold and permeates into meshes of the scaffold, thereby forming the embolism piece.

According to one embodiment of the present application, the preparation of the hydrogel-containing solution comprises: the hydrogel is placed in a vessel, and the solution is added to the vessel with stirring, followed by addition of the crosslinking agent with stirring, to thereby form a solution containing the hydrogel.

According to one embodiment of the present application, the preparing of the hydrogel-containing solution further comprises: adding a thrombus-promoting agent having a function of promoting thrombus formation into the container and stirring.

According to one embodiment of the present application, the thrombolytic agent comprises lyophilized human fibrinogen, hemocoagulase from snake venom, vitamin K, aminomethylbenzoic acid, or tranexamic acid.

According to one embodiment of the present application, the dissolution solution comprises an acetic acid solution or a glutaraldehyde solution.

According to one embodiment of the present application, the material of the embolic element comprises a hydrogel, and the step of disposing the embolic element comprises: and (3) fitting strip-shaped hydrogel to the inner surface or the outer surface of the stent, and infiltrating the hydrogel into meshes of the stent, so as to form the embolism piece.

According to one embodiment of the present application, the hydrogel material includes chitosan, alginic acid or chitin.

According to the technical scheme, the intracavity occluder and the processing method thereof have the advantages and positive effects that:

the intraluminal occluder provided herein includes a stent, a flow blocking membrane, and an embolic element. Through setting up the choked flow membrane in the internal week of support to the side design that will hinder the flow membrane is the unsmooth surface or the cylinder assorted structure with the side of support, makes this application can utilize the inside great space of support to hold and hinders the flow membrane, and can guarantee that the setting of hindering the flow membrane can not influence the compliance of support. In addition, in the conveying process, the stent can be contracted in the sheath, so that the plug piece arranged between the stent and the flow blocking membrane cannot be broken due to direct contact with the sheath, and the stent can be plugged into the sheath easily.

Drawings

Various objects, features and advantages of the present application will become more apparent from the following detailed description of preferred embodiments thereof, when considered in conjunction with the accompanying drawings. The drawings are merely exemplary of the application and are not necessarily drawn to scale. In the drawings, like reference characters designate the same or similar parts throughout the different views. Wherein:

figure 1 is a schematic structural view of an endoluminal occluding device shown in accordance with an exemplary embodiment;

FIG. 2 is a schematic cross-sectional view taken along line A-A of FIG. 1;

figure 3 is a schematic cross-sectional view of an endoluminal occluding device shown in accordance with another exemplary embodiment;

figures 4 to 9 are each a schematic structural view of an endoluminal occluding device according to several different exemplary embodiments.

The reference numerals are explained below:

100. a support;

101. a raised portion;

102. a recessed portion;

200. a flow-blocking membrane;

201. a connection path;

202. a connection path;

300. an actuator member.

Detailed Description

Exemplary embodiments that embody features and advantages of the present application are described in detail below in the specification. It is to be understood that the present application is capable of various modifications in various embodiments without departing from the scope of the application, and that the description and drawings are to be taken as illustrative and not restrictive in character.

In the following description of various exemplary embodiments of the present application, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration various exemplary structures, systems, and steps in which aspects of the present application may be practiced. It is to be understood that other specific arrangements of parts, structures, example devices, systems, and steps may be utilized, and structural and functional modifications may be made without departing from the scope of the present application. Moreover, although the terms "over," "between," "within," and the like may be used in this specification to describe various example features and elements of the application, these terms are used herein for convenience only, e.g., in accordance with the orientation of the examples described in the figures. Nothing in this specification should be construed as requiring a specific three dimensional orientation of structures in order to fall within the scope of this application.

Referring to fig. 1, a schematic view of the configuration of the intraluminal occluding device as set forth in the present application is representatively illustrated. In the exemplary embodiment, the intraluminal occluder proposed in the present application is exemplified by the repair of a proximal or distal laceration of a dissecting layer applied to thoracic aorta endoluminal repair. Those skilled in the art will readily appreciate that various modifications, additions, substitutions, deletions, or other changes may be made to the specific embodiments described below in order to apply the relevant designs of the present application to other types of occluders or other application scenarios, and such changes are within the scope of the principles of the endoluminal occluder as set forth herein.

Figures 4 to 8 are schematic structural views of the endoluminal occluding device shown according to several different exemplary embodiments, respectively.

In one embodiment of the present application, as shown in fig. 1, the intraluminal occluding device proposed by the present application comprises a stent 100, a flow-blocking membrane 200 and an embolic element 300. Referring to fig. 2, a schematic cross-sectional view taken along line a-a of fig. 1 is representatively illustrated in fig. 2. The structure, connection mode and functional relationship of the main components of the endoluminal occlusion device proposed in the present application will be described in detail below with reference to the above drawings.

As shown in fig. 1 and 2, in an embodiment of the present application, the stent 100 has a hollow structure, the stent 100 includes two end surfaces and a side surface connected between the two end surfaces, and the stent 100 may be a metal mesh framework. Wherein the side of the stent 100 is a concave-convex surface, i.e. the side of the stent 100 has a convex part 101 and a concave part 102, the convex part 101 is convex with respect to the average circumference of the stent 100 (i.e. approximately corresponding to the average diameter of the stent 100), and the concave part 102 is concave with respect to the average circumference of the stent 100. On this basis, the obstructing membrane 200 is disposed on the inner circumference of the stent 100, and the obstructing membrane 200 includes two end faces and a side face connected between the two end faces. The side surface of the flow blocking film 200 is a concave-convex surface matched with the side surface of the stent 100, so that the flow blocking film 200 positioned inside the stent 100 keeps the same shape as the stent 100 with the concave-convex surface (for example, a wavy surface) after being sewn with the stent 100, and the stent 100 keeps close fit with the flow blocking film 200 inside the stent 100, thereby keeping the same elasticity. The plug member 300 is disposed between the side of the flow blocking membrane 200 and the side of the stent 100. In view of the above, set up in the inner periphery of support 100 through hindering flow film 200 to the side design that will hinder flow film 200 is the concave-convex surface assorted structure with the side of support 100, makes this application can utilize the inside great space of support 100 to hold and hinders flow film 200, and can guarantee that the setting of hindering flow film 200 can not influence the compliance of support 100. Also, since the stent 100 is contracted inside the sheath during the delivery process, the plug 300 provided between the stent 100 and the obstructing membrane 200 is not broken due to direct contact with the sheath, and the stent 100 can be inserted into the sheath relatively easily. In addition, the design that the embolism piece 300 is arranged between the flow blocking membrane 200 and the support 100 is adopted, so that the thromboplastization is facilitated, and the thrombus-blocking membrane can be used for fixing a suture to prevent the suture from cutting the flow blocking membrane 200.

In one embodiment of the present application, the side surface of the flow blocking film 200 is partially connected to the side surface of the stent 100, and both of the connection paths 201 are located at each of the convex portions 101 of the concave-convex surface and have a closed loop shape along the circumferential direction of the stent 100.

In one embodiment of the present application, as shown in fig. 2, the end surface of the flow-blocking membrane 200 is partially connected with the end surface of the stent 100, and the connection path 202 of the two may have a closed loop shape having a size (e.g., diameter) smaller than the inner diameter of the shelf of the cancellous bone and concentric with the stent 100. Through the design, the application can further promote the support 100 and the laminating nature between the choked flow membrane 200 of its inside, guarantees the holistic elasticity of device and shutoff effect.

Specifically, as shown in fig. 2, in an embodiment of the present application, the connection path 202 between at least one end surface of the current blocking film 200 and the corresponding end surface of the stent 100 may include at least two closed figures (two are shown in the figure), which are concentric and have different sizes.

Specifically, as shown in fig. 2, in an embodiment of the present application, a connection path 202 of an end surface of the current blocking film 200 and an end surface of the stent 100 may be circular. In some embodiments, the connecting path 202 between the end surface of the flow-blocking film 200 and the end surface of the stent 100 may also be in other closed loop shapes, such as an oval, a polygon, an irregular figure, and the like, but not limited thereto.

In one embodiment of the present application, the flow blocking film 200 and the stent 100 may be partially connected by sewing. On this basis, the connection path 201 of the side surface of the flow blocking film 200 and the side surface of the stent 100, and the connection path 202 of the end surface of the flow blocking film 200 and the end surface of the stent 100, which are described above, can be understood as the suture path of the suture thread.

As shown in fig. 1 and 2, in an embodiment of the present application, the plug member 300 may have a substantially ring-shaped structure, and the position of the plug member 300 having the ring-shaped structure on the inner surface (or the outer surface) of the stent 100 may correspond to the convex portion 101 of the concave-convex surface of the stent 100. On this basis, when the concave-convex surface of the stent 100 has a plurality of convex portions 101, a plurality of the plug members 300 may be arranged corresponding to the plurality of convex portions 101 of the concave-convex surface, respectively.

Based on the design that the plug member 300 has a ring structure, and at the same time, based on the design that the side surface of the flow blocking membrane 200 is partially connected with the side surface of the stent 100 through the closed connection path 201, in the present embodiment, the plug member 300 having a ring structure may be preferably disposed on the inner surface (or the outer surface) of the side surface of the stent 100 where the flow blocking membrane 200 is connected. Through the above design, the present application can provide protection for the connection between the side of the flow blocking membrane 200 and the side of the stent 100 (for example, the suture line at the suture between the two) by using the plug 300 while providing the function of promoting thrombosis by using the plug 300, so that the suture line is not easily scraped off.

In an embodiment of the present application, the plug member 300 is partially connected to both the side of the flow blocking membrane 200 and the side of the stent 100, and the connection path may be located in at least one of the convex portion 101 and the concave portion 102 of the concave-convex surface. On the basis, the side of the obstructing membrane 200 and the side of the stent 100 may be connected separately in any form at other positions, and the plug 300 and the side of the stent 100 may be connected separately in any form at other positions. In other words, when the plug member 300 is connected to the side of the flow-blocking membrane 200 and the side of the stent 100 in a common manner, the separate connection of any two of the three at other positions is not limited.

Referring to fig. 3, a schematic cross-sectional view of the intraluminal occluding device of the present application in another exemplary embodiment is representatively illustrated in fig. 3, and specific cross-sectional locations and viewing angles can be referenced to line a-a in fig. 2.

In one embodiment of the present application, the tether 300 may be disposed on the outer periphery of the side of the stent 100, as shown in fig. 3.

Referring to fig. 4, a schematic structural view of the intraluminal occluding device as set forth in the present application in another exemplary embodiment is representatively illustrated in fig. 4.

As shown in fig. 4, in one embodiment of the present application, the placement position of the plug member 300 on the inner surface (or outer surface) of the stent 100 may correspond to the recessed portion 102 of the concave-convex surface of the stent 100. On this basis, when the concave-convex surface of the stent 100 has a plurality of concave portions 102, a plurality of the plug members 300 may be arranged corresponding to the plurality of concave portions 102 of the concave-convex surface, respectively. Accordingly, when the plug 300 is correspondingly disposed in the recessed portion 102, the resistance of the plug 300 to sheath retraction (retraction of the intraluminal occluder into the sheath) can be reduced, and the occluder can be more easily retracted into the delivery device, in other words, the present invention can be applied to a delivery device of a smaller size.

Referring to fig. 5, a schematic structural view of the intraluminal occluding device of the present application in another exemplary embodiment is representatively illustrated in fig. 5.

As shown in fig. 5, in an embodiment of the present application, the positions of the plug members 300 on the inner surface (or the outer surface) of the stent 100 may correspond to the convex portions 101 and the concave portions 102 of the concave-convex surface of the stent 100, respectively. On this basis, when the concave-convex surface of the stent 100 has a plurality of convex portions 101 and a plurality of concave portions 102, a plurality of the plug members 300 may be arranged corresponding to the plurality of convex portions 101 and the plurality of concave portions 102 of the concave-convex surface, respectively.

Referring to fig. 9, a schematic structural view of the intraluminal occluding device of the present application in another exemplary embodiment is representatively illustrated in fig. 9.

As shown in fig. 9, in one embodiment of the present application, the side of the stent 100 may be cylindrical, i.e., the stent 100 has a substantially cylindrical structure. The side surface of the flow-blocking film 200 is a cylindrical surface matched with the side surface of the stent 100, so that the flow-blocking film 200 positioned inside the stent 100 keeps the same shape as the stent 100 with the cylindrical surface after being sewn with the stent 100, and the stent 100 can be tightly attached to the flow-blocking film 200 inside the stent 100, so that the same flexibility is kept. On this basis, the plug 300 is disposed between the side of the flow blocking membrane 200 and the side of the stent 100.

As shown in fig. 9, based on the design that the lateral surface of the stent 100 and the lateral surface of the flow-blocking membrane 200 are respectively matched with cylindrical surfaces, in an embodiment of the present application, the plug member 300 may be a membrane structure covering the outer periphery of the stent 100 (the plug member 300 is disposed on the outer surface of the stent 100) or the inner periphery (the plug member 300 is disposed between the stent 100 and the flow-blocking membrane 200). It should be noted that fig. 9 specifically shows the cross-sectional axial configuration of the tether 300 for ease of illustration and understanding. In some embodiments, when the side surface of the stent 100 and the side surface of the flow-blocking membrane 200 are respectively in the shape of matching cylindrical surfaces, the plug 300 may also be designed similarly to the embodiment shown in fig. 1 and 4, for example, the plug 300 may be a plurality of plugs arranged at intervals along the axial direction of the stent 100, but not limited to this.

Referring to fig. 6, a schematic structural view of the intraluminal occluding device as set forth in the present application in another exemplary embodiment is representatively illustrated in fig. 6.

As shown in fig. 6, unlike the embodiment shown in fig. 1, 4 and 5 in which the plug member 300 is designed as a multi-stage structure, in an embodiment of the present application, the plug member 300 may be a membrane structure covering the outer periphery of the stent 100 (the plug member 300 is disposed on the outer surface of the stent 100) or the inner periphery (the plug member 300 is disposed between the stent 100 and the flow-blocking membrane 200). It should be noted that fig. 6 specifically shows the cross-sectional axial configuration of the tether 300 for ease of illustration and understanding.

Referring to fig. 7, a schematic structural view of the intraluminal occluding device as set forth in the present application in another exemplary embodiment is representatively illustrated in fig. 7.

As shown in fig. 7, unlike the width design of the plug members 300 in the embodiment shown in fig. 1, in an embodiment of the present application, when the plug members 300 are arranged corresponding to the convex portions 101 of the concave-convex surface, the width of each plug member 300 in the axial direction may be substantially equal to the width of the convex portion 101 in the axial direction.

Referring to fig. 8, a schematic structural view of the intraluminal occluding device as set forth in the present application in another exemplary embodiment is representatively illustrated in fig. 8.

As shown in fig. 8, unlike the width design of the plug members 300 in the embodiment shown in fig. 4, in an embodiment of the present application, when the plug members 300 are arranged corresponding to the concave portions 102 of the concave-convex surface, the width of each plug member 300 in the axial direction may be substantially equal to the width of the concave portion 102 in the axial direction.

In one embodiment of the present application, the material of the embolic element 300 may comprise a PET film, a sponge, a foam, a gauze, or a hydrogel.

It should be noted here that the intraluminal occluders shown in the drawings and described in this specification are only a few examples of the many types of intraluminal occluders that can employ the principles of the present application. It should be clearly understood that the principles of the present application are in no way limited to any of the details or any of the components of the endoluminal occluding device shown in the drawings or described in the present specification.

Based on the above detailed description of several exemplary embodiments of the endoluminal occluder proposed in the present application, an exemplary embodiment of a method of manufacturing the endoluminal occluder proposed in the present application will be described in detail below.

In one embodiment of the present application, a method for processing an intraluminal occlusion device includes:

providing a bracket 100, wherein the bracket 100 is of a hollow structure, the bracket 100 comprises two end faces and a side face connected between the two end faces, and the side face of the bracket 100 is a concave-convex surface or a cylindrical surface;

the inner circumference of the stent 100 is provided with a flow blocking film 200, the flow blocking film 200 comprises two end faces and a side face connected between the two end faces, and the side face of the flow blocking film 200 is a concave-convex surface or a cylindrical surface matched with the side face of the stent 100;

the tether 300 is provided between the side of the obstructing membrane 200 and the side of the stent 100, or at the outer circumference of the side of the stent 100.

In an embodiment of the present application, when the material of the plug member 300 includes a PET film, the step of disposing the plug member 300 may specifically include: cutting the PET film to a length equal to the circumference of the stent 100; stretching the PET film in a length direction and/or a width direction; the PET film is disposed between the side of the flow blocking film 200 and the side of the stent 100, or disposed at the outer circumference of the side of the stent 100.

In another embodiment of the present application, when the material of the embolic element 300 comprises hydrogel, the step of disposing the embolic element 300 may specifically comprise: the hydrogel-containing solution and the stent 100 are poured into a mold and placed at a constant temperature so that the hydrogel adheres to the surface of the stent 100 and penetrates into the meshes of the stent 100, thereby forming the embolic element 300.

Based on the above process design for disposing the embolic element 300 of a material comprising hydrogel, in one embodiment of the present application, the preparation of the hydrogel-containing solution may specifically comprise: the hydrogel is placed in a vessel, and the solution is added to the vessel with stirring, followed by addition of the crosslinking agent with stirring, to thereby form a solution containing the hydrogel.

Further, in one embodiment of the present application, the preparing of the hydrogel-containing solution may further include: adding a thrombus-promoting agent having a function of promoting thrombus formation into the container and stirring.

Specifically, in one embodiment of the present application, the thrombolytic agent can include lyophilized human fibrinogen, snake venom thrombin, vitamin K, aminomethylbenzoic acid, or tranexamic acid.

Specifically, in one embodiment of the present application, the dissolution solution comprises an acetic acid solution. The application utilizes a dissolving solution such as an acetic acid solution to quickly and fully dissolve substances such as chitosan and the like which are not easy to dissolve in water.

Specifically, in one embodiment of the present application, the crosslinking agent may comprise a glutaraldehyde solution. In view of the above, the present application utilizes a cross-linking agent, such as glutaraldehyde, to effect conversion of linear or slightly branched macromolecules into a three-dimensional network, thereby enhancing the strength, heat resistance, abrasion resistance, solvent resistance, etc., of the hydrogel solution and the embolic agent 300 formed therefrom. Based on the design that the material of the occluding member 300 comprises hydrogel, in another embodiment of the present application, the step of providing an occluding member 300 having a material comprising hydrogel may further comprise: strips of hydrogel are adhered to the inner or outer surface of the stent 100 and the hydrogel infiltrates into the pores of the stent 100, thereby forming the embolic elements 300.

In one embodiment of the present application, when the material of the embolic element 300 comprises hydrogel, the material of the hydrogel may specifically comprise chitosan, alginic acid or chitin.

Based on the above exemplary description of the method for manufacturing the endoluminal occlusion device proposed by the present application, several different specific embodiments according to the design concept of the present application will be exemplified below.

In one embodiment, the present application employs a coating capable of promoting thrombopoiesis, and the fabricated intraluminal occluder mainly comprises a stent 100, a flow-blocking membrane 200 and an embolic element 300 (i.e., a thrombogenic coating). The support 100 plays a supporting role, the flow blocking film 200 plays a role in blocking blood flow, the plug promoting piece 300 can adopt a fluffy structure with a porous structure on the surface, such as a PET film, and the like, so that blood flow can be disturbed, thrombus formation in a cavity can be promoted, an intracavity plugging device can be assisted to better plug a false cavity, and a suture line at a sewing position can be protected.

Specifically, the tether 300, such as a PET film, having a width approximately equal to the width between the two recessed regions 102, is cut to a length equal to the overall perimeter of the endoluminal occluding device (e.g., approximately equal to the perimeter of the stent 100). The cut PET film is stretched several times in the length and width directions to be fluffy, and the stretched fluffy PET film is sewn to the convex part 101 of the stent 100 by using sewing threads. Specifically, the PET film may be placed between the stent 100 and the choke film 200 and sewn along the two protruding portions 101 on the same connecting line, or the PET film may be placed on the outer circumference of the stent 100 and sewn along the two protruding portions 101 on the same connecting line. The sewing process specifically includes attaching a strip of PET film to the flow blocking film 200, and sewing the strip of PET film to the protruding portion 101 of the stent 100. Of course, in other embodiments, the PET film, the flow blocking film 200 and the stent 100 at the above positions may be sewn together.

When the PET film is sewn to the recess 102 of the metal stent 100, the PET film may be placed between the stent 100 and the choke film 200 and sewn along the two recess 102 on the same line, and also placed at the two recess 102 on the outer circumference of the stent 100 and sewn.

Unlike the embodiment described above that uses a PET film as the tether 300, in another embodiment, the tether 300 may be made of foam or sponge. For example, a material such as sponge or foam may be cut to a length equal to the overall perimeter of the endoluminal occluding device and to a width approximately equal to the width between the two recessed portions 102. The cut sponge and foam are sewn to the protruding portion 101 of the stent 100 and its connecting line using a sewing thread. Because the sponge and the foam have porous structures, the blood flow in the false cavity can be disturbed, and the sponge and the foam are relatively soft and adjustable in thickness, the intracavity occluder can be more favorably collected into the sheath.

Unlike the embodiments described above that use PET film or foam and sponge as the embolic element 300, in yet another embodiment, the embolic element 300 can be made of hydrogel. For example, a hydrogel (e.g., chitosan, alginic acid, chitin, etc.) may be coated on the stent 100. Specifically, 1.0g of chitosan may be weighed into a clean beaker, added with 40ml of 2% acetic acid solution and stirred for dissolution, then added with 16ml of 2% glutaraldehyde and stirred, and drugs for promoting thrombopoiesis, such as lyophilized human fibrinogen, snake venom hemocoagulase, vitamin K, aminomethylbenzoic acid, tranexamic acid, etc., may also be added according to the need. Pouring the mixed solution and the stent 100 into a mold, and standing at a constant temperature of 50 ℃ for 1h to fix the hydrogel on the entire surface of the stent 100, so that the hydrogel can be attached to the outer surface of the stent 100 and penetrate into the meshes of the stent 100.

In another embodiment of the present application, when the side of the metal stent 100 is a cylindrical surface, a PET film may be interposed between the stent 100 and the flow blocking film 200 and sewn with the stent 100.

Further, taking the example of hydrogel as the embolic element 300, the hydrogel can be attached to the outer surface of the stent 100 and penetrate into the cells of the stent 100 when the stent 100 is cylindrical. When the side surface of the stent 100 is a concave-convex surface, the hydrogel strip can be attached to the convex portions 101 and/or the concave portions 102 of the stent 100 and can penetrate into the meshes of the stent 100. Compared with a thrombus-promoting coating (the thrombus-promoting piece 300) made of a material such as a PET (polyethylene terephthalate) film, the hydrogel can be coated on the stent 100 more uniformly, the sheath entering resistance of the intracavity occluder is reduced, and the suture thread is wrapped by the hydrogel and is less prone to being scratched. In addition, hydrogel materials themselves have certain capabilities of promoting thrombosis, such as: the positive charge on the surface of the chitosan can interact with a receptor (with negative charge) containing neuraminic acid residues on the surface of erythrocytes, so that the aggregation of erythrocytes is promoted, and the formation of thrombus is promoted. Accordingly, compared with the design that the structure for promoting thrombopoiesis of the existing occluder has a volume space which is difficult to ignore, and is difficult to store in the sheath with a small diameter after radial compression, when hydrogel is used as the embolism piece 300, the hydrogel can greatly gap the volume of the embolism piece 300, so that the radial dimension of the intraluminal occluder after radial compression is small, the intraluminal occluder can be stored in the sheath with a small diameter more easily, and the intraluminal occluder is convenient to be transported to a target position in a blood vessel through the sheath.

It should be noted herein that the fabrication of the endoluminal occluding device shown in the drawings and described in the present specification is but a few examples of the many fabrication methods that the principles of the present application can be employed. It should be clearly understood that the principles of the present application are in no way limited to any of the details or any steps of the method of manufacturing the endoluminal occluder shown in the drawings or described in the present specification.

In summary, the intraluminal occluding device proposed by the present application comprises a stent 100, a flow blocking membrane 200 and a plug member 300. Through setting up in the internal week of support 100 flow blocking membrane 200 to the side design of flow blocking membrane 200 is the concave convex surface or the cylinder assorted structure with the side of support 100, makes this application can utilize the inside great space of support 100 to hold flow blocking membrane 200, and can guarantee that flow blocking membrane 200's setting can not influence the compliance of support 100. Also, since the stent 100 is contracted inside the sheath during the delivery process, the plug 300 provided between the stent 100 and the obstructing membrane 200 is not broken due to direct contact with the sheath, and the stent 100 can be inserted into the sheath relatively easily.

Exemplary embodiments of the intraluminal occluder and method of manufacturing the intraluminal occluder set forth in the present application are described and/or illustrated above in detail. The embodiments of the present application are not limited to the specific embodiments described herein, but rather, components and/or steps of each embodiment may be utilized independently and separately from other components and/or steps described herein. Each component and/or step of one embodiment can also be used in combination with other components and/or steps of other embodiments. When introducing elements/components/etc. described and/or illustrated herein, the articles "a," "an," and "the" are intended to mean that there are one or more of the elements/components/etc. The terms "comprising," "including," and "having" are intended to be inclusive and mean that there may be additional elements/components/etc. other than the listed elements/components/etc.

While the intraluminal occluding device and method of manufacturing the intraluminal occluding device presented herein have been described in terms of various specific embodiments, those skilled in the art will recognize that the practice of the present application can be practiced with modification within the spirit and scope of the claims.

Claims

1. An intraluminal occluding device comprising:

the support is of a hollow structure and comprises two end faces and a side face connected between the two end faces, and the side face of the support is a concave-convex surface or a cylindrical surface;

the flow resistance film is arranged on the inner periphery of the bracket and comprises two end faces and a side face connected between the two end faces, and the side face of the flow resistance film is a concave-convex surface or a cylindrical surface matched with the side face of the bracket; and

an actuator member disposed between a side of the flow-blocking membrane and a side of the stent.

2. The endoluminal occluder of claim 1, wherein the endoluminal occluder comprises a plurality of said embolic elements, positioned to correspond to convex and/or concave portions of the concave-convex surface, respectively.

3. The endoluminal occluding device of claim 1 wherein the tether is a membranous structure wrapped around the inner circumference of the stent.

4. The endoluminal occlusion device of claim 1, wherein the tether is partially co-joined with the side of the flow-blocking membrane and the side of the stent, with connection paths in the convex and/or concave portions of the concave-convex surface.

5. The endoluminal occlusion device of claim 1 wherein the material of the embolic element comprises a PET film, a sponge, a foam, a gauze, or a hydrogel.

6. The endoluminal occluder of claim 1, wherein the side surfaces of the flow-blocking membrane are partially connected to the side surfaces of the stent, the connection paths being located in the convex and/or concave portions of the concave-convex surface.

7. The endoluminal occluder of claim 6, wherein the connecting path between the side of the flow-blocking membrane and the side of the stent is in the shape of a closed loop along the circumference of the stent.

8. The endoluminal occluding device of claim 1, wherein the end surface of the flow blocking membrane is locally connected with the end surface of the stent, and the connection path is in a closed loop shape having a size smaller than the inner diameter of the stent and concentric with the stent.

9. The endoluminal occluder of claim 8, wherein the connection path of at least one end surface of the flow-blocking membrane to the corresponding end surface of the stent comprises at least two of said closed figures, both concentric and unequal in size.

10. A method of manufacturing an endoluminal occluding device, comprising:

providing a support, wherein the support is of a hollow structure and comprises two end faces and a side face connected between the two end faces, and the side face of the support is a concave-convex surface or a cylindrical surface;

arranging a flow resistance film on the inner periphery of the bracket, wherein the flow resistance film comprises two end faces and a side face connected between the two end faces, and the side face of the flow resistance film is a concave-convex surface or a cylindrical surface matched with the side face of the bracket;

and arranging an embolism piece between the side surface of the flow-resisting membrane and the side surface of the bracket or on the periphery of the side surface of the bracket.

11. The method of claim 10, wherein the material of the tether comprises a PET film, and the step of disposing the tether comprises:

cutting the PET film to a length equal to the circumference of the support;

stretching the PET film in a length direction and/or a width direction;

and arranging the PET film between the side surface of the flow resistance film and the side surface of the bracket or on the periphery of the side surface of the bracket.

12. The method of claim 10, wherein the material of the embolic element comprises hydrogel, and the step of disposing the embolic element comprises:

pouring the solution containing the hydrogel and the scaffold into a mold and standing at a constant temperature, so that the hydrogel is attached to the surface of the scaffold and permeates into meshes of the scaffold, thereby forming the embolism piece.

13. The method of manufacturing an endoluminal closure device according to claim 12, wherein the preparing of the hydrogel-containing solution comprises:

the hydrogel is placed in a vessel, and the solution is added to the vessel with stirring, followed by addition of the crosslinking agent with stirring, to thereby form a solution containing the hydrogel.

14. The method for manufacturing an endoluminal closure device according to claim 13, wherein the preparing of the hydrogel-containing solution further comprises:

adding a thrombus-promoting agent having a function of promoting thrombus formation into the container and stirring.

15. The method of claim 14, wherein the thrombolytic agent comprises lyophilized human fibrinogen, hemocoagulase venom, vitamin K, aminomethylbenzoic acid, or tranexamic acid.

16. The method for manufacturing an endoluminal occluding device according to claim 13, wherein the dissolving solution comprises an acetic acid solution or a glutaraldehyde solution.

17. The method of claim 10, wherein the material of the embolic element comprises hydrogel, and the step of disposing the embolic element comprises:

and (3) fitting strip-shaped hydrogel to the inner surface or the outer surface of the stent, and infiltrating the hydrogel into meshes of the stent, so as to form the embolism piece.

18. The method of claim 10, wherein the hydrogel comprises chitosan, alginic acid or chitin.