CN114403968B - Intracavity occluder and processing method thereof - Google Patents

Intracavity occluder and processing method thereof Download PDF

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Publication number
CN114403968B
CN114403968B CN202111667679.6A CN202111667679A CN114403968B CN 114403968 B CN114403968 B CN 114403968B CN 202111667679 A CN202111667679 A CN 202111667679A CN 114403968 B CN114403968 B CN 114403968B
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Prior art keywords
bracket
stent
hydrogel
occluder
endoluminal
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CN114403968A (en
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李安伟
汤凯丽
王永胜
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Hangzhou Wei Qiang Medical Technology Co ltd
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Hangzhou Wei Qiang Medical Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/12031Type of occlusion complete occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12159Solid plugs; being solid before insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B2017/12004Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)

Abstract

The application provides an intracavity plugging device and a processing method of the plugging device, wherein the intracavity plugging device comprises a bracket, a flow blocking film and a bolt promoting piece; the support is of a hollow structure and comprises two end faces and side faces connected between the two end faces, and the side faces of the support are concave-convex surfaces or cylindrical surfaces; the choke film is arranged on the inner periphery of the bracket and comprises two end surfaces and side surfaces connected between the two end surfaces, and the side surfaces of the choke film are concave-convex surfaces or cylindrical surfaces matched with the side surfaces of the bracket; the bolt-promoting piece is arranged between the side face of the flow-blocking film and the side face of the bracket. Through the design, the application can utilize a larger space in the bracket to accommodate the choke film, and can ensure that the arrangement of the choke film can not influence the flexibility of the bracket. In addition, in the conveying process, the stent can be contracted in the sheath, the bolt-promoting piece arranged between the stent and the flow-blocking film can not 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 application relates to the technical field of medical instruments, in particular to an intracavity occluder and a processing method of the intracavity occluder.
Background
The main mode of treatment aortic dissection in the market at present is chest aortic intracavity repair, but intracavity repair only can shutoff interbedded proximal breach, and the existence of distal breach can lead to the false chamber to have continuous blood flow to pour into, and then leads to the continuous expansion of false chamber. One of the current treatment methods for distal lacerations is the technique of embolization of a false lumen, which blocks blood flow in the false lumen.
The artificial cavity embolism technology (implantation) is to fill a spring ring, an embolic agent, a special embolic device and the like in the interlayer artificial cavity, slow or block blood flow in the artificial cavity, promote thrombosis of the artificial cavity, achieve the purposes of preventing the expansion of the artificial cavity and promoting aortic reconstruction. The common embolic devices comprise a spring ring, biological glue, embolic agent, candy plug (Candy-plug) and the like, and the embolic device has the advantages that the artificial cavity is large, a plurality of openings exist, a plurality of spring rings are required to be filled, the operation difficulty is high, the filling effect is poor, and blood flows can be easily flushed out from other openings; the principle of a Candy plug (Candy-plug) is the same as that of a spring ring plug, and a blind end covered stent similar to Candy is placed into a false cavity through a false cavity breach to reduce blood flow of the false cavity; the above embolism device is to block the blood flow in the false cavity by filling the false cavity, so as to promote thrombosis, and has no part capable of accelerating thrombosis, and can not reach the effect of thrombosis in the false cavity 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 drawbacks of the prior art and to provide an endoluminal sealer that combines good thrombolysis and better flexibility of the stent.
Another main object of the present application is to overcome at least one of the above-mentioned drawbacks of the prior art and to provide a method for manufacturing an endoluminal occluder.
In order to achieve the above purpose, the application adopts the following technical scheme:
according to one aspect of the present application there is provided an endoluminal occluder comprising a stent, a flow blocking membrane and a plug member; the support is of a hollow structure and comprises two end faces and side faces connected between the two end faces, and the side faces of the support are concave-convex surfaces or cylindrical surfaces; the flow blocking film is arranged on the inner periphery of the bracket and comprises two end faces and side faces connected between the two end faces, and the side faces of the flow blocking film are concave-convex surfaces or cylindrical surfaces matched with the side faces of the bracket; the bolt promotion piece is arranged between the side face of the flow blocking film and the side face of the bracket.
According to one embodiment of the application, the endoluminal stopper comprises a plurality of said thrombolytic members positioned in correspondence with the convex and/or concave portions of the concave-convex surface, respectively.
According to one embodiment of the application, the bolt-promoting member is a membrane layer structure coated on the inner periphery of the bracket.
According to one embodiment of the application, the bolt-promoting element is locally connected together with the side face of the choke film and the side face of the bracket, and the connecting path is located at the convex part and/or the concave part of the concave-convex surface.
According to one embodiment of the application, the material of the thrombolytic member comprises a PET film, sponge, foam, gauze or hydrogel.
According to one embodiment of the application, the side surface of the choke film is locally connected with the side surface of the bracket, and the connecting path is positioned at the convex part and/or the concave part of the concave-convex surface.
According to one embodiment of the present application, the connecting path between the side surface of the choke film and the side surface of the bracket has a closed loop shape along the circumferential direction of the bracket.
According to one embodiment of the application, the end face of the choke film is locally connected with the end face of the bracket, and the connecting path is in a closed loop shape which is smaller than the inner diameter of the bracket in size and concentric with the bracket.
According to one embodiment of the application, the connecting path of at least one end face of the flow blocking film and the corresponding end face of the bracket comprises at least two closed patterns which are concentric and of unequal size.
According to another aspect of the present application, there is provided a method of processing an endoluminal occluder comprising: providing a support, wherein the support is of a hollow structure, the support comprises two end faces and side faces connected between the two end faces, and the side faces of the support are concave-convex surfaces or cylindrical surfaces; the inner periphery of the bracket is provided with a choke film, the choke film comprises two end surfaces and side surfaces connected between the two end surfaces, and the side surfaces of the choke film are concave-convex surfaces or cylindrical surfaces matched with the side surfaces of the bracket; a bolt-promoting element is arranged between the side surface of the choke film and the side surface of the bracket or at the periphery of the side surface of the bracket.
According to one embodiment of the present application, the material of the bolt-promoting member includes a PET film, and the step of disposing the bolt-promoting member includes: cutting the PET film to a length equal to the circumference of the stent; stretching the PET film in a length direction and/or a width direction; the PET film is arranged between the side surface of the choke film and the side surface of the bracket or is arranged on the periphery of the side surface of the bracket.
According to one embodiment of the present application, the material of the thrombolytic member comprises hydrogel, and the step of disposing the thrombolytic member comprises: pouring the solution containing the hydrogel and the stent into a mould for constant temperature placement, so that the hydrogel is attached to the surface of the stent and permeates into the meshes of the stent, and the thrombus promoting piece is formed.
According to one embodiment of the present application, the preparation of a solution containing a hydrogel comprises: the hydrogel is placed in a container, a dissolution solution is added to the container and stirred, and a crosslinking agent is added and stirred, thereby forming a solution containing the hydrogel.
According to one embodiment of the application, the preparation of the hydrogel-containing solution further comprises: adding thrombolytic agent with thrombosis promoting function into the container, and stirring.
According to one embodiment of the application, the thrombolytic agent comprises lyophilized human fibrinogen, snake venom hemagglutinase, vitamin K, aminomethylbenzoic acid or tranexamic acid.
According to one embodiment of the 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 thrombolytic member comprises hydrogel, and the step of disposing the thrombolytic member comprises: and attaching the strip-shaped hydrogel to the inner surface or the outer surface of the bracket, and penetrating the hydrogel into the meshes of the bracket to form the bolt-promoting piece.
According to one embodiment of the present application, the hydrogel material includes chitosan, alginic acid or chitin.
According to the technical scheme, the intra-cavity plugging device and the processing method thereof provided by the application have the advantages and positive effects that:
the application provides an intracavity plugging device which comprises a bracket, a flow blocking film and a bolt promoting piece. The flow blocking film is arranged on the inner periphery of the bracket, and the side surface of the flow blocking film is designed to be of a structure matched with the concave-convex surface or the cylindrical surface of the side surface of the bracket, so that the flow blocking film can be accommodated by utilizing a larger space in the bracket, and the arrangement of the flow blocking film can be ensured not to influence the flexibility of the bracket. In addition, in the conveying process, the stent can be contracted in the sheath, the bolt-promoting piece arranged between the stent and the flow-blocking film can not 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 the preferred embodiments of the application, when taken in conjunction with the accompanying drawings. The drawings are merely exemplary illustrations of the application and are not necessarily drawn to scale. In the drawings, like reference numerals refer to the same or similar parts throughout. Wherein:
FIG. 1 is a schematic illustration of the structure of an endoluminal occluder according to an exemplary embodiment;
FIG. 2 is a schematic cross-sectional view taken along line A-A of FIG. 1;
FIG. 3 is a schematic cross-sectional view of an endoluminal occluder in accordance with another exemplary embodiment;
fig. 4 to 9 are schematic views of structures of endoluminal occluders according to several different exemplary embodiments, respectively.
The reference numerals are explained as follows:
100. a bracket;
101. a protruding portion;
102. a recessed portion;
200. a choke film;
201. a connection path;
202. a connection path;
300. a bolt-promoting member.
Detailed Description
Exemplary embodiments that embody features and advantages of the present application are described in detail in the following description. It will be understood that the application is capable of various modifications in various embodiments, all without departing from the scope of the application, and that the description and drawings are intended to be illustrative in nature and not to be limiting.
In the following description of various exemplary embodiments of the application, reference is made to the accompanying drawings, which form a part hereof, and in which are shown by way of illustration various exemplary structures, systems, and steps in which aspects of the 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 description to describe various exemplary features and elements of the application, these terms are used herein for convenience only, e.g., in terms of the orientation of the examples depicted in the drawings. Nothing in this specification should be construed as requiring a particular three-dimensional orientation of the structure in order to fall within the scope of the application.
Referring to fig. 1, a schematic structural diagram of an endoluminal occluder in accordance with the present application is representatively illustrated. In this exemplary embodiment, the endoluminal occluder of the present application is described as applied to the repair of a proximal or distal laceration of a dissection by an endoluminal thoracic aortic prosthesis. Those skilled in the art will readily appreciate that many modifications, additions, substitutions, deletions, or other changes may be made to the embodiments described below in order to adapt the relevant designs of the present application to other types of occluders or other application scenarios, and such changes remain within the principles of the present application as set forth herein for an endoluminal occluder.
Fig. 4 to 8 are schematic views of the structure of an endoluminal occluder according to several different exemplary embodiments, respectively.
As shown in fig. 1, in one embodiment of the present application, the endoluminal occluder of the present application comprises a stent 100, a flow blocking membrane 200 and a thrombolytic member 300. Referring to FIG. 2 in conjunction, a schematic cross-sectional view taken along line A-A in FIG. 1 is representatively illustrated in FIG. 2. The structure, connection mode and functional relation of the main components of the endoluminal occluder according to the present application will be described in detail below with reference to the above-mentioned figures.
As shown in fig. 1 and 2, in an embodiment of the present application, the support 100 is a hollow structure, and the support 100 includes two end surfaces and a side surface connected between the two end surfaces, and the support 100 may be a metal mesh-shaped framework. The side surface of the support 100 presents a concave-convex surface, that is, the side surface of the support 100 is provided with a convex portion 101 and a concave portion 102, the convex portion 101 is convex relative to the average peripheral edge of the support 100 (that is, approximately corresponds to the average diameter of the support 100), and the concave portion 102 is concave relative to the average peripheral edge of the support 100. On this basis, the choke film 200 is disposed on the inner periphery of the bracket 100, and the choke film 200 includes two end surfaces and a side surface connected between the two end surfaces. The side surface of the choke film 200 presents a concave-convex surface matched with the side surface of the bracket 100, so that the choke film 200 positioned inside the bracket 100 maintains approximately the same shape as the bracket 100 with a concave-convex surface (e.g. a wavy surface) after being sewed with the bracket 100, and the bracket 100 is tightly attached to the choke film 200 inside the bracket, so that the same elasticity is maintained. The bolt-actuating member 300 is disposed between the side of the choke film 200 and the side of the bracket 100. Accordingly, by disposing the choke film 200 on the inner periphery of the bracket 100 and designing the side surface of the choke film 200 to have a structure matching with the concave-convex surface of the side surface of the bracket 100, the application can utilize the larger space inside the bracket 100 to accommodate the choke film 200 and ensure that the arrangement of the choke film 200 does not affect the flexibility of the bracket 100. In addition, during the delivery process, since the stent 100 is contracted in the sheath, the bolt-promoting member 300 disposed between the stent 100 and the choke film 200 is not broken by direct contact with the sheath, and the stent 100 can be easily inserted into the sheath. In addition, the present application adopts the design that the bolt promoting member 300 is arranged between the choke film 200 and the bracket 100, which is beneficial to promoting thrombosis on one hand and can be used for fixing suture on the other hand, so as to prevent the suture from cutting the choke film 200.
In an embodiment of the present application, the side surface of the choke film 200 is partially connected to the side surface of the bracket 100, and the connecting paths 201 of the two are located at each protruding portion 101 of the concave-convex surface, and have a closed loop shape along the circumferential direction of the bracket 100.
In one embodiment of the present application, as shown in fig. 2, the end surface of the choke film 200 is partially connected to the end surface of the stent 100, and the connecting path 202 of the two may be in a closed loop shape having a size (e.g., diameter) smaller than the inner diameter of the frame of the cancellous bone and concentric with the stent 100. Through the design, the application can further improve the fitting property between the bracket 100 and the flow blocking film 200 inside the bracket, and ensure the whole elasticity and the blocking effect of the device.
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 choke film 200 and the corresponding end surface of the bracket 100 may include at least two closed patterns (two are shown in the figure), which are concentric and have unequal sizes.
Specifically, as shown in fig. 2, in an embodiment of the present application, a connection path 202 between an end surface of the choke film 200 and an end surface of the bracket 100 may be circular. In some embodiments, the connecting path 202 between the end surface of the choke film 200 and the end surface of the bracket 100 may have other closed loop shapes, such as oval, polygonal, or irregular patterns, but not limited thereto.
In one embodiment of the present application, the blocker film 200 may be partially attached to the stent 100 by stitching. On this basis, the connection path 201 between the side surface of the choke film 200 and the side surface of the bracket 100 and the connection path 202 between the end surface of the choke film 200 and the end surface of the bracket 100 described above can be understood as a suture path of a suture thread.
As shown in fig. 1 and 2, in an embodiment of the present application, the bolt-promoting member 300 may have a substantially annular structure, and the location of the bolt-promoting member 300 having an annular structure on the inner surface (or the outer surface) of the bracket 100 may correspond to the protruding portion 101 of the concave-convex surface of the bracket 100. On the basis of this, when the concave-convex surface of the bracket 100 has a plurality of convex portions 101, a plurality of bolt-actuating members 300 may be arranged corresponding to the plurality of convex portions 101 of the concave-convex surface, respectively.
Based on the design of the bolt-actuating member 300 in the form of a ring structure and the design of the partial connection of the side surface of the choke film 200 to the side surface of the bracket 100 via the closed connection path 201, in this embodiment, the bolt-actuating member 300 in the form of a ring structure may be preferably disposed on the inner surface (or the outer surface) of the side surface of the bracket 100 at the position where it is connected to the choke film 200. Through the design, the application can provide protection for the connection between the side surface of the flow blocking film 200 and the side surface of the bracket 100 (such as the suture at the joint between the two) by utilizing the bolt promotion piece 300, and simultaneously provide the function of promoting thrombosis by utilizing the bolt promotion piece 300, so that the suture is not easy to scratch.
In an embodiment of the present application, the bolt-promoting member 300 is partially and commonly connected to the side surface of the choke film 200 and the side surface of the bracket 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 this basis, the side surface of the choke film 200 and the side surface of the bracket 100 may be separately connected in any form at other positions, and the bolt-promoting member 300 and the side surface of the bracket 100 may be separately connected in any form at other positions. In other words, when there is a joint form of joint between the bolt-promoting member 300 and the side surface of the choke film 200 and the side surface of the bracket 100, the individual connection of any two of the three at other positions is not limited.
Referring to fig. 3, a schematic cross-sectional view of an endoluminal occluder in accordance with the present application is representatively illustrated in fig. 3 and in another exemplary embodiment, reference is made to line A-A of fig. 2 for a particular cross-sectional position and view angle.
In one embodiment of the application, as shown in FIG. 3, a bolt-actuating member 300 may be provided on the outer periphery of the side of the stent 100.
Referring to fig. 4, a schematic structural view of an endoluminal occluder in accordance with the present application in another exemplary embodiment is representatively illustrated in fig. 4.
As shown in fig. 4, in an embodiment of the present application, the bolt-promoting member 300 may be disposed on the inner surface (or the outer surface) of the stent 100 at a position corresponding to the concave portion 102 of the concave-convex surface of the stent 100. On this basis, when the concave-convex surface of the bracket 100 has a plurality of concave portions 102, a plurality of bolt-actuating members 300 may be arranged corresponding to the plurality of concave portions 102 of the concave-convex surface, respectively. Accordingly, when the bolt-promoting members 300 are disposed at the recessed portions 102, the resistance of the bolt-promoting members 300 to the retraction of the sheath (retraction of the endoluminal occluder into the sheath) can be reduced, so that the occluder can be more easily retracted into the delivery device, in other words, the application can be applied to a delivery device of smaller size.
Referring to fig. 5, a schematic structural view of an endoluminal occluder in accordance with 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 bolt-promoting member 300 may be disposed at a position on the inner surface (or the outer surface) of the bracket 100 corresponding to the convex portion 101 and the concave portion 102 of the concave-convex surface of the bracket 100, respectively. On this basis, when the concave-convex surface of the holder 100 has the plurality of convex portions 101 and the plurality of concave portions 102, the plurality of bolt-actuating 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 an endoluminal occluder in accordance with the present application in another exemplary embodiment is representatively illustrated in fig. 9.
As shown in fig. 9, in an embodiment of the present application, the side of the stand 100 may be cylindrical, i.e., the stand 100 may have a substantially cylindrical structure. The side surface of the choke film 200 is a cylindrical surface matched with the side surface of the bracket 100, so that the choke film 200 inside the bracket 100 maintains approximately the same shape as the bracket 100 with the cylindrical surface after being stitched with the bracket 100, and the bracket 100 and the choke film 200 inside the bracket can be kept closely attached, so as to maintain the same elasticity. On this basis, the bolt-actuating member 300 is disposed between the side of the choke film 200 and the side of the bracket 100.
As shown in fig. 9, based on the design that the side surface of the bracket 100 and the side surface of the choke film 200 are respectively in matched cylindrical surfaces, in an embodiment of the present application, the bolt-actuating member 300 may be a film layer structure coated on the outer periphery (the bolt-actuating member 300 is disposed on the outer surface of the bracket 100) or the inner periphery (the bolt-actuating member 300 is disposed between the bracket 100 and the choke film 200). For ease of illustration and understanding, the structural configuration of the bolt-actuating member 300 is shown in particular in fig. 9 in cross-section on the axial side. In some embodiments, when the side surface of the bracket 100 and the side surface of the choke film 200 are respectively matched cylindrical surfaces, the bolt-promoting member 300 may also be designed similar to that of the embodiment shown in fig. 1 and 4, for example, the bolt-promoting member 300 may be a plurality of bolt-promoting members spaced apart along the axial direction of the bracket 100, which is not limited thereto.
Referring to fig. 6, a schematic structural view of an endoluminal occluder in accordance with the present application in another exemplary embodiment is representatively illustrated in fig. 6.
As shown in fig. 6, unlike the embodiment of fig. 1, 4 and 5, in which the bolt-actuating member 300 has a multi-stage structure, in an embodiment of the present application, the bolt-actuating member 300 may have a membrane layer structure that is wrapped around the outer periphery (the bolt-actuating member 300 is disposed on the outer surface of the stent 100) or the inner periphery (the bolt-actuating member 300 is disposed between the stent 100 and the choke membrane 200). For ease of illustration and understanding, the structural configuration of the bolt-actuating member 300 is shown in particular in fig. 6 in cross-section on the axial side.
Referring to fig. 7, a schematic structural view of an endoluminal occluder in accordance with the present application in another exemplary embodiment is representatively illustrated in fig. 7.
As shown in fig. 7, in an embodiment of the present application, when the bolt-promoting members 300 are arranged corresponding to the convex portions 101 of the concave-convex surface, the width of each bolt-promoting member 300 in the axial direction may be substantially equal to the width of the convex portion 101 in which it is located, unlike the width design of the bolt-promoting member 300 in the embodiment shown in fig. 1.
Referring to fig. 8, a schematic structural view of an endoluminal occluder in accordance with the present application in another exemplary embodiment is representatively illustrated in fig. 8.
As shown in fig. 8, in an embodiment of the present application, when the bolt-promoting members 300 are arranged corresponding to the concave portions 102 of the concave-convex surface, the width of each bolt-promoting member 300 in the axial direction may be substantially equal to the width of the concave portion 102 in which it is located, unlike the width design of the bolt-promoting member 300 in the embodiment shown in fig. 4.
In one embodiment of the application, the material of the thrombolytic member 300 may include PET film, sponge, foam, gauze or hydrogel.
It should be noted herein that the endoluminal occluder shown in the figures and described in this specification is merely illustrative of the many types of endoluminal 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 details or any components of the endoluminal occluder shown in the figures or described in this specification.
Based on the above detailed description of several exemplary embodiments of the endoluminal occluder of the present application, an exemplary embodiment of a method of processing an endoluminal occluder of the present application will be described in detail.
In one embodiment of the present application, the method for processing an endoluminal occluder provided by the present application includes:
providing a support 100, wherein the support 100 is of a hollow structure, the support 100 comprises two end surfaces and side surfaces connected between the two end surfaces, and the side surfaces of the support 100 are concave-convex surfaces or cylindrical surfaces;
the inner periphery of the bracket 100 is provided with a flow blocking film 200, the flow blocking film 200 comprises two end surfaces and side surfaces connected between the two end surfaces, and the side surfaces of the flow blocking film 200 are concave-convex surfaces or cylindrical surfaces matched with the side surfaces of the bracket 100;
a bolt-actuating member 300 is provided between the side surface of the choke film 200 and the side surface of the bracket 100 or at the outer periphery of the side surface of the bracket 100.
In an embodiment of the present application, when the material of the bolt-promoting member 300 includes a PET film, the step of disposing the bolt-promoting 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 the length direction and/or the width direction; the PET film is disposed between the side surface of the choke film 200 and the side surface of the bracket 100 or on the outer circumference of the side surface of the bracket 100.
In another embodiment of the present application, when the material of the thrombolytic member 300 includes hydrogel, the step of disposing the thrombolytic member 300 may specifically include: the solution containing the hydrogel 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 mesh openings of the stent 100, thereby forming the thrombus formation member 300.
Based on the above-described process design for providing a bolt-promoting member 300 comprising a hydrogel, in one embodiment of the present application, the preparation of a solution containing a hydrogel may specifically include: the hydrogel is placed in a container, a dissolution solution is added to the container and stirred, and a crosslinking agent is added and stirred, thereby forming a solution containing the hydrogel.
Further, in an embodiment of the present application, the preparation of the hydrogel-containing solution may further include: adding thrombolytic agent with thrombosis promoting function into the container, and stirring.
In particular, in one embodiment of the application, the thrombolytic agent may comprise lyophilized human fibrinogen, snake venom hemagglutinase, vitamin K, aminomethylbenzoic acid or tranexamic acid.
Specifically, in one embodiment of the present application, the dissolution liquid includes an acetic acid solution. The application can make the dissolution of substances such as chitosan which are not easy to dissolve in water more rapid and sufficient by using the dissolution liquid such as acetic acid solution.
Specifically, in one embodiment of the present application, the crosslinking agent may include glutaraldehyde solution. In view of the above, the present application can achieve conversion of linear or slightly branched macromolecules into a three-dimensional network structure by using a crosslinking agent such as glutaraldehyde, thereby improving the strength, heat resistance, abrasion resistance, solvent resistance, etc. of the hydrogel solution and the thrombus formation 300 formed therefrom. Based on the design that the material of the bolt-promoting member 300 comprises a hydrogel, in another embodiment of the present application, the step of disposing the bolt-promoting member 300 that the material comprises a hydrogel may further comprise: the strip-shaped hydrogel is adhered to the inner surface or the outer surface of the stent 100, and the hydrogel is infiltrated into the mesh holes of the stent 100, thereby forming the bolt-promoting member 300.
In an embodiment of the present application, when the material of the thrombus promoting member 300 includes hydrogel, the material of the hydrogel may specifically include chitosan, alginic acid or chitin.
Based on the above-mentioned exemplary description of the method for processing an endoluminal occluder according to the present application, several different embodiments according to the design concept of the present application are illustrated below.
In one embodiment, the present application employs a stent-graft approach that promotes thrombosis, and the resulting endoluminal occluder generally comprises a stent 100, a flow blocking member 200, and a thrombolytic member 300 (i.e., a thrombogenic stent). The stent 100 plays a supporting role, the choke film 200 plays a role in preventing blood flow, the bolt promoting piece 300 can adopt a fluffy structure with a porous structure on the surface of a PET film and the like, so that the blood flow can be disturbed, the thrombus in a cavity can be promoted, the cavity occluder can be assisted to better occlude a false cavity, and a suture line at a suture position can be protected.
Specifically, the thrombus promoting member 300, such as a PET film, is cut to the same length as the entire circumference of the endoluminal stopper (e.g., approximately equal to the circumference of the stent 100), and the width of the PET film is approximately equal to the width between the two recessed regions 102. The cut PET film is stretched several times in the length and width directions to be fluffy, and the stretched and fluffed PET film is sewn to the protruding portion 101 of the bracket 100 by a sewing line. Specifically, the PET film may be placed between the bracket 100 and the choke film 200 and sewn along the two protruding portions 101 on the same line, or the PET film may be placed on the outer periphery of the bracket 100 and sewn along the two protruding portions 101 on the same line. The sewing process specifically includes attaching a strip-shaped PET film to the choke film 200, and then sewing with the protruding portion 101 of the stent 100. Of course, in other embodiments, the PET film, the choke film 200, and the stent 100 may be co-stitched.
When the PET film is sewn to the concave portions 102 of the metal bracket 100, the PET film may be placed between the bracket 100 and the choke film 200 and sewn along the two concave portions 102 on the same line, and also placed at the two concave portions 102 on the outer periphery of the bracket 100.
Unlike the embodiment described above that uses a PET film as the thrombolytic member 300, in another embodiment, the thrombolytic member 300 may be made of foam or sponge. For example, the sponge, foam, etc. material may be cut to the same length as the overall perimeter of the endoluminal occluder, with a width approximately equal to the width between the two recessed regions 102. The cut sponge and foam are sewn to the convex portion 101 of the bracket 100 and the connecting line thereof by using a suture. Because the sponge and the foam have porous structures, the sponge and the foam can interfere blood flow in the false cavity, are relatively soft and have adjustable thickness, and are more beneficial to the retraction of the endoluminal occluder into the sheath.
Unlike the embodiments described above that use PET film or foam and sponge as the thrombolytic member 300, in yet another embodiment, the thrombolytic member 300 can be made of hydrogel. For example, a hydrogel (e.g., chitosan, alginic acid, chitin, etc.) may be coated onto the stent 100. Specifically, 1.0g of chitosan can be weighed into a clean beaker, 40ml of 2% acetic acid solution is added for stirring and dissolution, 16ml of 2% glutaraldehyde is added for stirring, and medicines for promoting thrombosis, such as freeze-dried human fibrinogen, snake venom hemagglutinin, vitamin K, aminomethylbenzoic acid, tranexamic acid and the like, can be added according to the requirement. 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 whole surface of the stent 100, so that the hydrogel can be attached to the outer surface of the stent 100 and infiltrate into the mesh holes of the stent 100.
In another embodiment of the present application, when the side of the metal stent 100 is cylindrical, a PET film may be interposed between the stent 100 and the choke film 200 and sewn to the stent 100.
Further, taking hydrogel as an example of the bolt-promoting member 300, when the side surface of the stent 100 is cylindrical, the hydrogel may be attached to the outer surface of the stent 100 and may be infiltrated into the mesh openings of the stent 100. When the side surface of the stent 100 is a concave-convex surface, the strip-shaped hydrogel may be attached to the convex portion 101 and/or the concave portion 102 of the stent 100 and may be infiltrated into the mesh of the stent 100. Compared with the thrombus-promoting coating (thrombus-promoting piece 300) made of PET film and the like, the hydrogel can be more uniformly coated on the stent 100, so that the sheath resistance of the intra-cavity occluder is reduced, and the suture is wrapped by the hydrogel and is less prone to being scratched. In addition, hydrogel materials have certain capabilities of promoting thrombus, for example: the positive charge on the surface of chitosan can interact with receptors (negatively charged) containing neuraminic acid residues on the surface of erythrocytes to promote the aggregation of erythrocytes and further promote the formation of thrombus. Accordingly, compared with the structure of the existing occluder for promoting thrombosis, which has a volume space which is difficult to ignore and is difficult to be contained in a sheath tube with smaller diameter after radial compression, when the hydrogel is adopted as the thrombus promoting piece 300, the volume of the thrombus promoting piece 300 can be greatly clearance, so that the radial dimension of the endoluminal occluder after radial compression is smaller and the endoluminal occluder is easier to be contained in the sheath tube with smaller diameter, thereby being convenient to be transported to a target position in a blood vessel through the sheath tube.
It should be noted herein that the method of processing an endoluminal occluder shown in the drawings and described in this specification is merely illustrative of the many ways in which 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 details or any steps of the method of processing an endoluminal occluder as shown in the drawings or described in the present specification.
In summary, the endoluminal occluder of the present application comprises a stent 100, a blocking membrane 200 and a plug member 300. By arranging the choke film 200 on the inner periphery of the bracket 100 and designing the side surface of the choke film 200 to be in a structure matched with the concave-convex surface or the cylindrical surface of the side surface of the bracket 100, the application can utilize a larger space inside the bracket 100 to accommodate the choke film 200 and can ensure that the arrangement of the choke film 200 does not influence the flexibility of the bracket 100. In addition, during the delivery process, since the stent 100 is contracted in the sheath, the bolt-promoting member 300 disposed between the stent 100 and the choke film 200 is not broken by direct contact with the sheath, and the stent 100 can be easily inserted into the sheath.
Exemplary embodiments of the endoluminal occluder and method of processing an endoluminal occluder of the present application are described and/or illustrated in detail above. Embodiments of the 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 each step of one embodiment may also be used in combination with other components and/or steps of other embodiments. When introducing elements/components/etc. that are described and/or illustrated herein, the terms "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., in addition to the listed elements/components/etc.
While the endoluminal occluder and method of processing the endoluminal occluder of the present application has been described in terms of various specific embodiments, those skilled in the art will recognize that the application can be practiced with modification within the spirit and scope of the claims.

Claims (16)

1. An endoluminal occluder comprising:
the support is of a hollow structure, and comprises two end faces and side faces connected between the two end faces, wherein the side faces of the support are concave-convex surfaces or cylindrical surfaces;
the flow blocking film is arranged on the inner periphery of the bracket, the flow blocking film comprises two end surfaces and side surfaces connected between the two end surfaces, the side surfaces of the flow blocking film are concave-convex surfaces or cylindrical surfaces matched with the side surfaces of the bracket, the end surfaces of the flow blocking film are locally connected with the end surfaces of the bracket, the connecting path is in a closed loop shape with the size smaller than the inner diameter of the bracket and concentric with the bracket, the connecting path of at least one end surface of the flow blocking film and the corresponding end surface of the bracket comprises at least two closed loop shapes, and the at least two closed loop shapes are concentric and unequal in size; and
the bolt promotion piece is arranged between the side face of the flow blocking film and the side face of the bracket.
2. The endoluminal occluder of claim 1 wherein the endoluminal occluder comprises a plurality of the thrombus promotion members positioned to correspond to the raised and/or recessed portions of the concave-convex surface, respectively.
3. The endoluminal occluder of claim 1 wherein the thrombus promoting member is a membranous layer structure wrapped around the inner circumference of the stent.
4. The endoluminal occluder of claim 1 wherein the anchoring member is locally co-joined with the sides of the flow blocking membrane and the side of the stent, the joining path being at the convex and/or concave portions of the concave-convex surface.
5. The endoluminal occluder of claim 1 wherein the material of the thrombolytic member comprises a PET film, sponge, foam, gauze or hydrogel.
6. The endoluminal occluder of claim 1 wherein the sides of the flow blocking membrane are locally connected to the sides of the stent with connection paths at the raised and/or recessed portions of the concave-convex surface.
7. The endoluminal occluder of claim 6 wherein the path of the connection of the sides of the flow blocking membrane to the sides of the stent is in a closed loop shape circumferentially of the stent.
8. A method of processing an endoluminal occluder comprising:
providing a support, wherein the support is of a hollow structure, the support comprises two end faces and side faces connected between the two end faces, and the side faces of the support are concave-convex surfaces or cylindrical surfaces;
the inner periphery of the support is provided with a flow blocking film, the flow blocking film comprises two end surfaces and side surfaces connected between the two end surfaces, the side surfaces of the flow blocking film are concave-convex surfaces or cylindrical surfaces matched with the side surfaces of the support, the end surfaces of the flow blocking film are locally connected with the end surfaces of the support, the connecting path is in a closed loop shape with the size smaller than the inner diameter of the support and concentric with the support, the connecting path of at least one end surface of the flow blocking film and the corresponding end surface of the support comprises at least two closed loop shapes, and the at least two closed loop shapes are concentric and unequal in size;
a bolt-promoting element is arranged between the side surface of the choke film and the side surface of the bracket or at the periphery of the side surface of the bracket.
9. The method of claim 8, wherein the material of the thrombolytic member comprises a PET film, and the step of disposing the thrombolytic member comprises:
cutting the PET film to a length equal to the circumference of the stent;
stretching the PET film in a length direction and/or a width direction;
the PET film is arranged between the side surface of the choke film and the side surface of the bracket or is arranged on the periphery of the side surface of the bracket.
10. The method of claim 8, wherein the material of the thrombolytic member comprises a hydrogel and the step of disposing the thrombolytic member comprises:
pouring the solution containing the hydrogel and the stent into a mould for constant temperature placement, so that the hydrogel is attached to the surface of the stent and permeates into the meshes of the stent, and the thrombus promoting piece is formed.
11. The method of processing an endoluminal occluder of claim 10 wherein the preparation of the hydrogel-containing solution comprises:
the hydrogel is placed in a container, a dissolution solution is added to the container and stirred, and a crosslinking agent is added and stirred, thereby forming a solution containing the hydrogel.
12. The method of processing an endoluminal occluder of claim 11 wherein the preparation of the hydrogel-containing solution further comprises:
adding thrombolytic agent with thrombosis promoting function into the container, and stirring.
13. The method of claim 12, wherein the thrombolytic agent comprises lyophilized human fibrinogen, snake venom hemagglutinase, vitamin K, amimevalonate, or tranexamic acid.
14. The method of claim 11, wherein the dissolution fluid comprises an acetic acid solution or a glutaraldehyde solution.
15. The method of claim 8, wherein the material of the thrombolytic member comprises a hydrogel and the step of disposing the thrombolytic member comprises:
and attaching the strip-shaped hydrogel to the inner surface or the outer surface of the bracket, and penetrating the hydrogel into the meshes of the bracket to form the bolt-promoting piece.
16. The method of claim 8, wherein the material of the thrombolytic element comprises a hydrogel, and the hydrogel comprises chitosan, alginic acid or chitin.
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