CN115153953B

Movatterモバイル変換

Info

Publication number: CN115153953B
Application number: CN202211094868.3A
Authority: CN
Inventors: 俞华沣
Original assignee: Shenzhen Huahechuang Micro Medical Technology Co ltd
Current assignee: Shandong Chuang Micro Medical Technology Co ltd
Priority date: 2022-09-08
Filing date: 2022-09-08
Publication date: 2023-01-03
Anticipated expiration: 2042-09-08
Also published as: CN115153953A

Abstract

The three-dimensional braided stent and the manufacturing method thereof provided by the embodiment of the application have the advantages that the three-dimensional braided stent at least comprises a plurality of first three-dimensional combined braided filaments and second three-dimensional combined braided filaments which are braided in a staggered mode, other structures are not arranged on the three-dimensional braided stent, each three-dimensional combined braided filament is combined to comprise a first silk thread, a second silk thread and a third silk thread which are combined together, the first silk thread comprises a shape memory material, the second silk thread is a material with rigidity higher than a set threshold value, and the third silk thread is a material which is not transparent to X-rays, so that the three-dimensional braided stent simultaneously has shape memory, higher adherence performance and support performance, meanwhile, a whole visible-radiation image is called development along a spiral braiding direction under the X-rays, the developed third silk thread has no shooting dead angle in a vascular symptom, and the development effect can be improved.

Description

Three-dimensional braided stent and manufacturing method

Technical Field

The application belongs to the technical field of medical instruments, and particularly relates to a three-dimensional braided stent and a manufacturing method thereof.

Background

The current medical net rack can be used in a variety of medical scenarios, intracranial Aneurysm and carotid artery treatment are the most widely used scenarios, intracranial Aneurysm (IAN) is a common hemorrhagic cerebrovascular disease, is the most common cause of spontaneous Subarachnoid hemorrhage (SAH), and more than 85% of SAH is reported to be caused by Intracranial Aneurysm rupture. Early diagnosis, early cause treatment are crucial to reducing mortality, reducing complications and improving quality of life. Intracranial aneurysm treatment means are more and more, and in more than 10 years, the treatment level achieves qualitative leap, and the treatment is developed from traumatic craniotomy clamping operation to minimally invasive intravascular embolism treatment and even the current blood flow diversion device and covered stent pasting, so that the method becomes an important means for treating intracranial aneurysm. Carotid stenosis is a disease of hemodynamic disorder of neck blood vessels caused by atherosclerosis, takayasu arteritis, fibromuscular dysplasia and other causes. Carotid artery stenosis is a high risk factor of ischemic stroke at present and is an important cause of disability and death of patients. Clinically, according to the carotid stenosis degree (symptomatic carotid stenosis is more than or equal to 50 percent, and asymptomatic carotid stenosis is more than or equal to 70 percent) as an indication of surgical intervention, at present, there are 3 main means for clinically treating carotid stenosis: carotid Endarterectomy (CEA), carotid stenting (CAS) and drug therapy. However, the current medical net rack has many problems in use, such as difficulty in visualization, inability of visualization of 100% (approximate value), inability of smoothness in blood vessels, poor adhesion effect, and the like, which have many disadvantages.

Disclosure of Invention

One of the purposes of the embodiment of the application is as follows: the utility model provides a three-dimensional woven stent and a manufacturing method thereof, which aims to solve at least one of the problems that the woven stent is difficult to develop, cannot develop 100% (approximate value), cannot be smooth in blood vessels, has poor wall-adhering effect and the like in the prior art.

In order to solve the technical problem, the embodiment of the present application adopts the following technical solutions:

the embodiment of the first aspect of the application provides a three-dimensional braided stent, which at least comprises a plurality of three-dimensional combined braided wires which are braided in a staggered manner, wherein each first three-dimensional combined braided wire is braided along a first preset spiral direction, each second three-dimensional combined braided wire is braided along a second preset spiral direction, an included angle formed by a straight line of the first preset spiral direction and a straight line of the second preset spiral direction is a right angle or an acute angle, each three-dimensional combined braided wire comprises a first silk thread, a second silk thread and a third silk thread which are combined together, the first silk thread comprises a shape memory material, the second silk thread is a material with the rigidity strength higher than a set threshold value, and the third silk thread is a material which is not transparent to X-rays; a groove gap is formed among the first wire, the second wire and the third wire, and a coating formed after the coating solution is solidified is arranged in the groove gap.

In an alternative embodiment, the first, second and third wires are intertwined and extend helically in the same direction.

In an alternative embodiment, the first and second filaments are twisted around each other and extend helically in the same direction, and the third filament is helically wound around the outer surfaces of the first and second filaments.

In an alternative embodiment, the first, second and third wires each comprise a first, second and third helical segment arranged in radial succession; for each wire, the helix angle of the first helical segment and the helix angle of the third helical segment are both less than the helix angle of the second helical segment.

In an alternative embodiment, for each wire, the inner diameter of the first helical segment and the inner diameter of the third helical segment are both greater than the inner diameter of the second helical segment.

In an alternative embodiment, the first wire comprises at least one indentation in a sidewall thereof extending radially of the first wire.

In an alternative embodiment, the width of the indentations is between 1um-3um.

In an alternative embodiment, each dimple includes a plurality of diameter expansion sections that expand radially along the first wire, and a plurality of diameter reduction sections that reduce radially along the first wire, and the diameter expansion sections and the diameter reduction sections are alternately arranged at intervals.

In an alternative embodiment, the side wall of the first wire comprises at least one indent unit extending along the radial direction of the first wire, and each indent unit comprises a plurality of indent segments.

In an alternative embodiment, the plurality of dimple segments include a plurality of diameter-expanding dimple segments that expand in a radial direction of the first wire and a plurality of diameter-reducing dimple segments that reduce in a radial direction of the first wire, and the diameter-expanding dimple segments and the diameter-reducing dimple segments are alternately arranged at intervals.

In an alternative embodiment, at least two of the first, second and third wires are helically wound to form a plurality of spaced gaps therebetween.

In an alternative embodiment, at least two of the first, second, and third wires are wound spirally with a gap therebetween, which is integrally communicated in a spiral direction.

In an optional embodiment, the plurality of three-dimensional combined knitting yarns further include a plurality of third three-dimensional combined knitting yarns, each third three-dimensional combined knitting yarn is close to one of the first three-dimensional combined knitting yarns and is knitted along a third preset spiral direction, the third preset spiral direction is the same as the first preset spiral direction, or an included angle formed by a straight line of the third preset spiral direction and a straight line of the first preset spiral direction is a preset acute angle; or,

the three-dimensional combined weaving wire further comprises a plurality of third three-dimensional combined weaving wires, each third three-dimensional combined weaving wire is close to one of the second three-dimensional combined weaving wires and is woven along a third preset spiral direction, the third preset spiral direction is the same as the second preset spiral direction, or a straight line of the third preset spiral direction and a straight line of the second preset spiral direction form an included angle which is a preset acute angle.

In an alternative embodiment, the material forming the first wire comprises a nickel titanium alloy; and/or the material forming the second wire comprises a cobalt chromium alloy or stainless steel; and/or the material forming the third wire comprises a platinum alloy or a gold alloy.

Embodiments also provide a medical device comprising an introducer and a three-dimensional braided stent, the introducer configured to introduce the three-dimensional braided stent into a blood vessel.

The embodiment of the application also provides a manufacturing method of the three-dimensional braided stent, which comprises the following steps:

combining the first silk thread, the second silk thread and the third silk thread to form a first three-dimensional combined knitting silk and a second three-dimensional combined knitting silk; a groove gap is formed among the first silk thread, the second silk thread and the third silk thread;

laying a coating solution in the groove gaps of the first three-dimensional combined weaving wire and the second three-dimensional combined weaving wire and curing;

the solidified first three-dimensional combined knitting yarns and the solidified second three-dimensional combined knitting yarns are woven in a staggered mode to form a three-dimensional woven support; wherein the first wire comprises a shape memory material, the second wire is a material having a stiffness strength above a set threshold, and the third wire is an X-ray opaque material.

In an alternative embodiment, combining the first, second, and third filaments to form a three-dimensional combined braided filament comprises:

and winding the first silk thread, the second silk thread and the third silk thread mutually and extending spirally along the same direction to form the three-dimensional combined knitting silk.

In an alternative embodiment, the combining the first, second, and third filaments to form a three-dimensional combined braided filament includes:

winding the first and second filaments around each other and extending helically in the same direction;

and spirally winding the third silk thread on the outer side surfaces of the first silk thread and the second silk thread to form the three-dimensional combined braided silk.

The three-dimensional braided stent and the manufacturing method have the advantages that:

the three-dimensional braided stent and the manufacturing method thereof provided by the embodiment of the application have the advantages that the three-dimensional braided stent at least comprises a plurality of first three-dimensional combined braided wires and a plurality of second three-dimensional combined braided wires which are braided in a staggered mode, the three-dimensional braided stent is not provided with other structures, each three-dimensional combined braided wire comprises a first silk thread, a second silk thread and a third silk thread which are combined together, the first silk thread comprises a shape memory material, the second silk thread is a material with the rigidity higher than a set threshold value, and the third silk thread is a material which is not transparent to X-rays, so that the three-dimensional braided stent simultaneously has shape memory, higher adherence performance and support performance, meanwhile, the whole visible-radial image in the spiral braiding direction is called as development under the X-rays, the developed third silk thread does not shoot dead angles in angiographic images, the development effect can be improved, the three silk threads can form gaps, and the coating formed after the coating solution is solidified can be contained in the gaps through the structure, and therefore, the better anticoagulation effect can be realized.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required to be used in the embodiments or the prior art description will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings may be obtained according to these drawings without inventive labor.

Fig. 1a to 1c are schematic views illustrating the whole process before, during and after use in an application scenario of the three-dimensional woven stent in the embodiment of the present application;

fig. 1d to 1f are schematic views illustrating the whole process before, during and after use in another application scenario of the three-dimensional woven stent in the embodiment of the present application;

FIG. 2 is a schematic perspective view of a mesh body of a three-dimensional braided stent provided in accordance with an embodiment of the present disclosure;

FIG. 3 is an enlarged schematic view of the mesh body provided in FIG. 2;

FIG. 4 is an enlarged detail view of the mesh body provided in FIG. 3;

FIG. 5 is an enlarged detail view of portion A of FIG. 4;

FIG. 6 is an enlarged detail view of portion B of FIG. 5;

FIG. 7 is an expanded view of the cross-sectional structure of the wire;

FIG. 8 is a schematic structural diagram of a three-dimensional composite woven filament according to an embodiment of the present application;

fig. 9 is a side view of the three-dimensional combination braid of fig. 8.

FIG. 10 is a schematic view of a dimple structure according to an embodiment of the present application.

FIG. 11 is a second schematic view of the dimple structure in the present embodiment.

Reference numerals are as follows: 100-vessel, 200-stenotic artery, 300-three-dimensional braided stent, 400-introducer, 500-aneurysm, 1-mesh body, 11-first three-dimensional combined braided filament, 12-second three-dimensional combined braided filament, 101-first filament, 102-second filament, 103-third filament, 104-groove gap, 105-gap, 106-indentation.

Detailed Description

Reference will now be made in detail to embodiments of the present application, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the drawings are exemplary and intended to be used for explaining the present application and should not be construed as limiting the present application.

In the description of the present application, it is to be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like are used in the orientation or positional relationship indicated in the drawings for convenience in describing the present application and for simplicity in description, and are not intended to indicate or imply that the referenced devices or elements must have a particular orientation, be constructed in a particular orientation, and be operated in a particular manner, and are not to be considered limiting of the present application.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "plurality" means two or more unless specifically defined otherwise, wherein two or more includes two.

In this application, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can include, for example, fixed connections, removable connections, or integral parts; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or may be connected through the use of two elements or the interaction of two elements. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art as the case may be.

The following detailed description is made with reference to the accompanying drawings and examples:

referring to fig. 1a to 1f together, the embodiment of the present application first provides a medical device that can be used for expanding and supporting thenarrow artery 200 of fig. 1a to 1c or for healing theaneurysm 500.

Specifically, in a first application scenario of the embodiment of the present application, the three-dimensional woven stent of the present application may be a dense mesh, and its specific usage function is to prevent blood from flowing into theaneurysm 500 through the dense mesh, so that the lattice density or porosity of the three-dimensional woven stent needs to meet the requirement of preventing blood from permeating.

Further, in a second application scenario in the embodiment of the present application, the three-dimensional braided stent may be a loose mesh frame, and the function of the three-dimensional braided stent is mainly to expand and support thenarrow artery 200, so that a dense mesh framework is not needed, and the three-dimensional braided stent is different from the dense mesh in that the mesh density is sparse, the porosity is low, and greater compression on blood can be avoided.

It can be understood that the porosity of the three-dimensional braided stent of the present application can be adjusted as required, and this application is not described herein any more, and different porosities can be used in different application scenarios.

Fig. 1a to 1f show the narrow artery expanding support scenario of the present application, such as carotid artery, i.e. the second application scenario described above, and fig. 1d to 1f show the aneurysm medical application scenario of the present application, i.e. the first application scenario described above.

The three-dimensional woven stent can be used in a plurality of medical scenes, one of which can be a medical device for treating carotid artery stenosis, namely a carotid artery stent, and particularly, as shown in fig. 1a to 1c, the three-dimensional woven stent is firstly transported to a carotid artery stenosis part for example in the manner, then a micro catheter is removed, the three-dimensional woven stent is expanded from a compressed state to an expanded state, and the three-dimensional woven stent is tightly attached to the carotid artery, so that the carotid artery can be supported and the inner diameter of the carotid artery can be expanded, and the carotid artery stenosis can be treated.

Furthermore, the three-dimensional braided stent of the present application can also be used as a cerebrovascular device, and at present, the blood vessel has small size, tortuosity, multiple branches and slow blood flow and is easy to form thrombus, so that the device generally requires small size to reach the distal end of a cerebral artery, is flexible, has good passability, has good antithrombotic capability and good developability and can be accurately positioned, as shown in fig. 1d to 1f, after an aneurysm is formed in an artery, blood can enter theaneurysm 500, so that theaneurysm 500 is enlarged and ruptured to cause stroke, the three-dimensional braided stent 300 in the embodiment of the present application is positioned at the position of theaneurysm 500 in the above manner, and then is expanded in theblood vessel 100 to form a dense-mesh structure, so that the blood flow can be prevented for a narrow-diameter artery, and the filler can be separated by the blood flow if the filler is unstable, and the filler can be separated by the blood flow for the wide-diameter aneurysm 500, and the dense-mesh stent can be used to prevent the blood flow from entering.

In the following, the inventive concept of the present application will be explained in detail, and as shown in fig. 2, the three-dimensional woven stent provided by the embodiment of the present application is amesh body 1. As shown in fig. 3, the grid body is in a grid shape and includes a plurality of grids with the same or different porosities.

As shown in fig. 6, each three-dimensional combined braided wire includes afirst wire 101, asecond wire 102, and athird wire 103 combined together, and thefirst wire 101, thesecond wire 102, and thethird wire 103 respectively perform different functions.

Specifically, thefirst wire 101 includes a shape memory material, preferably, the shape memory material may be a Shape Memory Alloy (SMA), and the SMA is a material composed of two or more metal elements with a Shape Memory Effect (SME), and the SMA wire is used in the present application to enable the stent to be self-expandable, so that the stent can be smoothly delivered and can have a larger bending angle in the cranium.

The shape memory alloy can be nickel-titanium alloy, certainly can also be copper-based shape memory alloy, iron-based shape memory alloy in this application, in medical field, nickel-titanium alloy is preferred in this application, and nickel-titanium alloy on the one hand shape memory performance is stronger, and on the other hand oxidation resistance is strong, can resist the oxidation of oxygen molecule in the blood.

Further, in the embodiment of the present application, thefirst wire 101 uses a nickel-titanium alloy as the main body of the guide wire, the shape memory polymer is coated on the periphery of the nickel-titanium alloy, the inner core is formed of the nickel-titanium alloy, and the outer side of the double-layer shape memory structure is coated with the shape memory polymer.

In the embodiment of the application, thesecond silk thread 102 is a material with rigidity intensity higher than a set threshold value, namely the compression strength of thesecond silk thread 102 is high, the tensile shear strength is low, the supporting force of the stent is stronger by using high-strength alloy wires, the better attached blood vessel wall of the stent is ensured, and the problem of poor attachment wall caused by insufficient supporting force of the pure memory alloy wire stent is solved. Specifically, thesecond wire 102 may be a high-strength alloy wire, such as cobalt-chromium alloy, stainless steel, and the like, which is not limited in the present application.

Further, in a specific embodiment, thethird wire 103 is made of an X-ray opaque material, that is, thethird wire 103 has a visualization property, and specifically, thethird wire 103 of the present application may be a platinum alloy wire, a gold alloy wire, or the like, which may be visualized in medical exploration.

In addition, as shown in fig. 6 and 7,groove gaps 104 are formed among thefirst wires 101, thesecond wires 102 and thethird wires 103 in the embodiment of the present application, and a coating formed after the coating solution is cured is disposed in thegroove gaps 104, in the embodiment, because thefirst wires 101, thesecond wires 102 and thethird wires 103 are combined together, and because the cross section of each wire is circular, a gap is formed after the combination regardless of mutual adhesion, as shown in fig. 6 and 7, the present application places the coating solution in thegroove gaps 104 and then cures, and a "coating pool" is formed in the groove gaps between the wires, so that the anticoagulant effect is better.

In the embodiment of the present application, the mesh main body is formed by interweaving a plurality of first three-dimensional combinedknitting yarns 11 and a plurality of second three-dimensional combinedknitting yarns 12, the plurality of first three-dimensional combinedknitting yarns 11 and the plurality of second three-dimensional combinedknitting yarns 12 are interwoven to form a plurality of rhombic, square, rectangular, or elliptical meshes, and the like, each mesh may be compressed and expanded by the shape memory material of thefirst yarn 101, as shown in fig. 4, when in specific use, the plurality of meshes are formed to be distributed at intervals along a preset direction, each mesh has a compressed configuration and an expanded configuration, and the expanded configuration is formed after being expanded by the compressed configuration. Understandably, when the three-dimensional braided stent is positioned in the microcatheter, the mesh is in a compressed state under compression of the inner wall of the microcatheter, when the mesh is in a compressed configuration; when the three-dimensional woven stent is released from the microcatheter, the lattice expands radially and is deployed, with the lattice configured in the deployed configuration.

The mesh main body of the application particularly plays a supporting role, and is expanded and unfolded to be attached to a blood vessel when in use.

It should be noted that, as shown in fig. 7, agroove gap 104 is formed among thefirst wire 101, thesecond wire 102, and thethird wire 103, and may be formed by attaching thefirst wire 101, thesecond wire 102, and thethird wire 103 to each other, so that since thefirst wire 101, thesecond wire 102, and thethird wire 103 are all cylindrical, the cylinders of each guide wire are tangent after attaching, two wedge-shapedgroove gaps 104 are formed between the two cylinders, and at this time, the coating solution is contained therein, and then the coating solution is cured.

Further, agroove gap 104 is formed among thefirst silk thread 101, thesecond silk thread 102 and thethird silk thread 103, or thefirst silk thread 101, thesecond silk thread 102 and thethird silk thread 103 are mutually inserted, part of the silk threads adhere to each other, and part of the silk threads form an isolation space.

Further, thegroove spaces 104 may be formed among the first, second and

third filaments

101, 102 and 103, and the first, second and

third filaments

101, 102 and 103 may be all spiraled in one spiral direction, and preferably, the first, second and

third filaments

101, 102 and 103 are twisted with each other and spirally extend in the same direction, so as to form a "petal-like" shape, in which case the first, second and

third filaments

101, 102 and 103 are attached to each other, but the attached tangent line is also spiral since the first, second and

third filaments

101, 102 and 103 are spiral. This allows the first 101, second 102 and third 103 wires to be rotated to continuously adjust their relative positions, thereby allowing for more uniformity in the shape recovery or formation of the stretched/compressed shape.

Further, in the process of forming the petal-like shape, thesecond silk thread 102 is spiraled in one direction, then thefirst silk thread 101 is made to adhere to thesecond silk thread 102, and then thefirst silk thread 101 is spiraled in the same direction, so that thesecond silk thread 102 positioned at the innermost part can optimally support thefirst silk thread 101 and thethird silk thread 103 positioned at the outer part by using a rigid material as a basic core material for supporting in use.

In a preferred embodiment, in the process of forming the "petal-like" shape, after thethird thread 103 is attached to thefirst thread 101, thethird thread 103 is spiraled in the same direction, so that in the "petal-like" shape, thethird thread 103 is always located outside thefirst thread 101 and thesecond thread 102, i.e. thethird thread 103 is always exposed to the outermost portion, and can be completely captured by a medical imaging device when exposed to the outermost portion, so that the structure of the present application has a "100% development" effect.

Furthermore, in other embodiments, as shown in fig. 8, the first and

second filaments

101 and 102 are wound around each other and extend helically in the same direction, and thethird filament 103 is helically wound around the outer surfaces of the first and

second filaments

101 and 102.

In this embodiment, the first and

second filaments

101 and 102 are formed in a "petal-like" configuration as described above, wherein thesecond filament 102 is spiraled in one direction, and then thefirst filament 101 is made adherent to thesecond filament 102, and then thefirst filament 101 is spiraled in the same direction, such that in use thesecond filament 102, which is innermost, can provide optimal support for the outer first and

third filaments

101 and 103, using a rigid material as the primary core of support.

Third filaments 103 are then wound around the outer surface offirst filament 101 andsecond filament 102 to form a "coil" such that thethird filaments 103 are always outside offirst filament 101 andsecond filament 102 in the "coil" configuration, i.e., thethird filaments 103 are always exposed to the outermost portion, where they are completely captured by a medical imaging device, such that the structure of the present application has a "100% development" effect.

In the embodiment not shown in the figures of the present application, each of the first, second and

third wires

102, 103 comprises a first, second and third helical segment arranged in sequence in the radial direction; for each wire, the helix angle of the first helical segment and the helix angle of the third helical segment are both less than the helix angle of the second helical segment.

It should be noted here that, through setting up first spiral section, second spiral section and third spiral section, realized three-dimensional weaving support multi-section formula design on extending direction, through the helix angle of first spiral section with the helix angle of third spiral section all is less than the helix angle of second spiral section, the helix angle that is located the spiral section in middle part also is greater than the helix angle of the spiral section that is located the tip for middle part spiral span is bigger, tip spiral span is less so that the density of silk thread is great, make the holding power of support stronger, make the better laminating vascular wall of support, on the other hand middle part spiral span is bigger, thereby more spaces are provided for memory is flexible, this application passes through multi-section formula design, through improving the difference of helix angle, more delicate structure has been formed, make laminating nature, support nature and flexible memory effect better.

Illustratively, the helix angles of the first helical segment and the third helical segment are both 20 ° and 40 ° for each filament, although the application is not limited thereto, and in practice the helix angles of the first helical segment and the third helical segment may be set to be in one predetermined range, e.g., 20-30 °, and the helix angles of the second helical segment may be set to be in another predetermined range, e.g., 40-60 °, as desired, although it should be noted that the minimum value of the another predetermined range in this example should be greater than the maximum value of the one predetermined range to avoid the situation where the helix angles of the first helical segment and the third helical segment are equal to the helix angle of the second helical segment.

It can be understood that the helix angle of the present application refers to the acute angle between the tangent line of the cylindrical helix and the straight generatrix of the cylindrical surface passing through the tangent point on the cylindrical surface generated by the helix, and the present application is not described herein any more.

For example, the first, second and

third filaments

102 and 103 of the present application are not limited to include only the three helical segments, and in a preferred embodiment, the first, second and

third filaments

102 and 103 may be controlled to be formed by less than 10 helical segments, and the 10 helical segments are sequentially connected end to end, so that the helical angle of each helical segment may be designed specifically, and the single form variable may be adjusted to the form variable of each of the multiple helical segments through the buffering of multiple helical angles, thereby buffering the expansion memory, and being beneficial to protecting the entire three-dimensional braided stent, thereby improving the service life of the three-dimensional braided stent.

Further, the segmented design allows each helical segment to move relative to each other, i.e., the entire mesh body may not move synchronously when in use; therefore, when the three-dimensional woven stent is attached to a blood vessel for a long time, each spiral section generates corresponding relative movement to be better attached to the inner wall of the blood vessel, so that the three-dimensional woven stent has better bending adherence performance, and the three-dimensional woven stent cannot collapse when being attached to the blood vessel for a long time.

Furthermore, based on the similar principle of the above-mentioned segment type, the first, second and

third wires

102 and 103 each comprise a first, second and third helical segment arranged in order in the radial direction; for each wire, the inner diameter of the first helical section and the inner diameter of the third helical section are both greater than the inner diameter of the second helical section for each wire.

It still needs to explain here that, through setting up first spiral section, second spiral section and third spiral section, realized that the three-dimensional support of weaving is the design of the multistage formula on the extending direction, through the internal diameter of first spiral section with the internal diameter of third spiral section all is greater than the internal diameter of second spiral section, the internal diameter that is located the spiral section at middle part also is less than the internal diameter that is located the spiral section of tip for middle part spiral section is more sparse, tip spiral section is thicker on the one hand like this, make the holding power of support stronger, make the better laminating vascular wall of support, on the other hand middle part spiral section is thinner, thereby for memory is flexible to provide more spaces, this application passes through the design of multistage formula, through the difference of improving the spiral section internal diameter, more delicate structure has been formed, make laminating nature, support nature and flexible memory effect better.

Illustratively, the inner diameter of the first spiral segment and the inner diameter of the third spiral segment are both 40um and the inner diameter of the second spiral segment is 20um for each wire, although the application is not limited thereto, and in practice the inner diameters of the first spiral segment and the third spiral segment may be set to be in one predetermined range M1, e.g. 40-60um, and the inner diameters of the second spiral segment may be set to be in another predetermined range M2, e.g. 20-30um, as required, but it should be noted that the maximum value of the another predetermined range M2 in this example should be smaller than the minimum value of the above-mentioned one predetermined range M1 to avoid the situation where the inner diameters of the first spiral segment and the third spiral segment are equal to the inner diameter of the second spiral segment.

Illustratively, the first, second and

third wires

102 and 103 may be controlled to be composed of less than 10 helical segments, and the 10 helical segments are sequentially arranged from head to tail, so that the inner diameter of each helical segment may be specifically designed, and the single form variable may be adjusted to the respective form variable of the multiple helical segments through buffering of multiple inner diameters, thereby buffering the expansion and contraction memory, and facilitating to protect the whole three-dimensional braided stent, thereby improving the service life of the three-dimensional braided stent.

Further, the segmented design allows each helical segment to move relative to each other, i.e., the entire mesh body may not move synchronously when in use; therefore, when the three-dimensional woven stent is attached to a blood vessel for a long time, each spiral section generates corresponding relative movement to better attach to the inner wall of the blood vessel, so that the three-dimensional woven stent has better bending and attaching performance, and the three-dimensional woven stent cannot collapse when being attached to the blood vessel for a long time.

Further, as shown in fig. 10, in a preferred embodiment, the side wall of thefirst wire 101 of the present application includes at least oneindent 106 extending along the radial direction of thefirst wire 101, thefirst wire 101 is a shape memory guide wire, the present application designs the shape memory guide wire in a targeted manner, and a plurality ofindents 106 are disposed on the side wall of the shape memory guide wire, so that as the plurality ofindents 106 are formed on the initial shape memory guide wire, when the shape memory guide wire is stretched, theindents 106 can buffer deformation caused by stretching, bending, and the like, thereby avoiding generation of stress, and improving the efficiency of shape memory recovery and the use effect of shape memory.

By way of example, the width of thedent 106 is between 1um and 3um, and the inventor of the present application finds that the micron-sized dent 106 can be regarded as a common surface, and does not have mechanical phenomena such as surface tension or adsorption force on blood, so that thedent 106 can buffer deformation caused by expansion, bending and the like, thereby avoiding stress generation, improving the efficiency of shape memory recovery and the use effect of shape memory, and meanwhile, not adsorbing blood, so that blood blockage or blood drainage is not caused, and the blood flow characteristic is not changed.

Further illustratively, the width of thedimple 106 is 1um, 1.5um, 2um, 2.5um and 3um, which is not described herein again.

In a further preferred embodiment, eachdimple 106 includes a plurality of diameter-expanding sections that are radially expanded along thefirst wire 101, and a plurality of diameter-reducing sections that are radially reduced along thefirst wire 101, and the diameter-expanding sections and the diameter-reducing sections are alternately arranged at intervals.

It should be understood that, in this embodiment, the radial direction, i.e., the extending direction of the filament, is the corresponding spiral direction when the filament is in a spiral shape, in other words, the radial direction here is the length direction of the filament, and it should be noted that, in this application, the radial direction obviously may be the direction from one end of the filament to the other end, or the direction from the other end to one end, that is, the radial direction may be from the proximal end to the distal end, or from the distal end to the proximal end, which is not limited in this application.

Illustratively, the radial direction in this embodiment is from the proximal end to the distal end of the wire, the proximal end in this application being the end closer to the operator or the operating instrument, and the distal end being the end further away from the operator or the operating instrument.

This application is through setting up every thedent 106 includes many edges the radial expanding section, many edges offirst silk thread 101 radial expanding diameter reducing section, the expanding section with the setting of reducing section interval in turn to makedent 106 narrow when the radial time width of silk thread, can be when deformation, becausewide dent 106 has the great space that supplies the deformation, thereby can furthest reduce local surface grow or the volume grow of support after the deformation and produce stress, thereby be favorable to prolonging the life who makes the three-dimensional support of weaving.

Another preferred embodiment is shown below, as shown in fig. 11, in this preferred embodiment, thedents 106 are discontinuous, that is, thedents 106 in the above embodiment are cut into a plurality, in this embodiment, the sidewall of thefirst wire 101 includes at least onedent 106 unit extending along the radial direction of thefirst wire 101, and eachdent 106 unit includes a plurality ofdent 106 segments. Such a process is advantageous in that it is possible to maximally prevent the mechanical phenomena such as surface tension or adsorption force to blood, and by arranging a plurality of thedent 106 segments, eachdent 106 segment can be arranged to have a length lower than a lower value that just prevents the mechanical phenomena such as surface tension or adsorption force to blood, for example, the length of thedent 106 segment is 1um to 3um.

The plurality ofdents 106 comprise a plurality of diameter-expandingdents 106 which are radially expanded along thefirst wire 101 and a plurality of diameter-reducingdents 106 which are radially reduced along thefirst wire 101, and the diameter-expandingdents 106 and the diameter-reducingdents 106 are alternately arranged at intervals.

Meanwhile, a plurality of diameter-expandingdents 106 expanding in the radial direction of thefirst wire 101 and a plurality of diameter-reducingdents 106 reducing in the radial direction of thefirst wire 101, which are alternately arranged, may be arranged by the length of thedents 106 such that the length of thewide dents 106 is lower than a low value which may avoid mechanical phenomena such as surface tension or adsorption force to blood, for example, the length of thewide dents 106 is 1um to 3um.

It is understood that expanding in the present application may refer to a direction in which the diameter (i.e., the inner diameter for dimple 106) is a constant wider diameter, such as shown in the above embodiments, or may refer to a direction in which the diameter is increasing, as will be described in more detail below.

In a preferred embodiment, each of thedimples 106 includes a plurality of expanding sections that expand in a radial direction of thefirst wire 101, and a plurality of reducing sections that reduce in a radial direction of thefirst wire 101, and the expanding sections and the reducing sections are alternately arranged at intervals, so that the overall diameter of theentire dimple 106 is gradually reduced and then increased, and the overall dimple tends to have a same shape and change in radial direction, and the portion of the maximum diameter between the expanding and reducing sections is relatively more subjected to stress relief of deformation no matter which direction the deformation is directed, and the expanding sections are more subjected to stress relief of deformation if the constant diameter is alternately arranged.

To thedimple 106 of micro-nano level, it can go on through the technique of laser marking, utilizes the laser of default power to shine on the silk thread, carves according to certain laser sculpture route, and this application does not do this and give unnecessary for description.

The macroscopic level of the first tothird filaments 103 of the present application is explained in detail below.

In some embodiments, a plurality ofgaps 105 are formed between at least two of the first, second and

third wires

101, 102 and 103 by spiral winding, that is, two wires of the first, second and

third wires

101, 102 and 103 form a gap with each other, that is, the spiral parameters of the two wires are different, that is, the spirals are not synchronized, so that thegap 105 with the interval is formed, it is understood that thegaps 105 with the interval cannot be synchronized by having the same spiral parameter, that is, the spirals, and only the gap is configured between the two wires by virtue of the gap being a complete and continuous one, and the two wires are parallel to each other (that is, the tangent of any point on one wire is parallel to the tangent of the corresponding point on the other wire), so that the present application forms a plurality ofgaps 105 with the interval, and only the spiral parameters of the two wires are different, for example, or the spiral directions are different, so that thegaps 105 with the interval are realized, and the two wires can be periodically or non-periodically contacted with each other and then be further away from each other.

The first, second and

third threads

101, 102 and 103 may also be spirally wound to form a plurality ofgaps 105 arranged at intervals, that is, the three threads have different spiral parameters, such as different spiral angles or different spiral directions, so that thegaps 105 arranged at intervals can be realized, and at this time, the three threads may contact each other periodically or non-periodically and then move away from each other.

Further, in another embodiment of the present application, at least two of thefirst wire 101, thesecond wire 102, and thethird wire 103 are wound by a spiral to form agap 105 integrally communicating in a spiral direction. That is, there are two cases, one of which is that the tangent line of any point of one silk thread is parallel to the tangent line of the corresponding point of the other one or two silk threads, that is, the spiral parameters of at least two of the three silk threads are consistent and are arranged in parallel; the second is that at least two of the three filaments are not parallel to each other, but the difference of the helix angles is small, for example, less than 0.5 °, at this time, although they are not parallel, they can be regarded as being approximately parallel in the three-dimensional braided stent, if the two filaments are long enough, they will contact each other, but there is no contact in the three-dimensional braided stent, at this time, it can also reach the situation that at least two of thefirst filament 101, thesecond filament 102 and thethird filament 103 form agap 105 integrally communicated in the helical direction by helical winding, which is not described in detail herein.

In the above embodiment, the existence of the gap can improve the accommodation amount of the coating solution of the present application, so that a higher anticoagulation effect can be achieved.

In the embodiment of the present application, the number of the first filamentous guiding wire and the second filamentous guiding wire may be tens of, for example, 48, 72, or 96, although the present application is not limited thereto, and the number of the first filamentous guiding wire and the second filamentous guiding wire may be any value, as long as the requirement of the volume, the area, and the like can be satisfied.

Further, in other embodiments of the present application, each of the first three-dimensional combinedknitting yarns 11 is knitted along a first preset spiral direction, each of the second three-dimensional combinedknitting yarns 12 is knitted along a second preset spiral direction, and an included angle formed by a straight line of the first preset spiral direction and a straight line of the second preset spiral direction is a right angle or an acute angle. As shown in fig. 4, a plurality of grids are formed after weaving, and it can be seen that when the included angle is a right angle, the grids are rectangular or square, and when the included angle is an acute angle, the grids are rhombic or parallelogram, which is not described in detail herein. In addition, from the shape of net, when the contained angle is the acute angle, can see that under the equal area, the net is more narrow when the contained angle is the acute angle, after handling like this, can avoid blood to permeate the net to avoid blood to get into the aneurysm.

Further, in a preferred embodiment of the present application, the three-dimensional combined woven filaments further include a plurality of third three-dimensional combined woven filaments, each of the third three-dimensional combined woven filaments is close to one of the first three-dimensional combinedwoven filaments 11, and is woven along a third preset spiral direction, the third preset spiral direction is the same as the first preset spiral direction, or the third preset spiral direction is a straight line and the included angle formed by the first preset spiral direction is a preset acute angle.

In an embodiment, the plurality of three-dimensional combined knitting yarns further include a plurality of third three-dimensional combined knitting yarns, each third three-dimensional combined knitting yarn is close to one of the second three-dimensional combinedknitting yarns 12 and is knitted along a third preset spiral direction, the third preset spiral direction is the same as the second preset spiral direction, or an included angle formed by a straight line of the third preset spiral direction and a straight line of the second preset spiral direction is a preset acute angle.

In the two embodiments, the third three-dimensional combined knitting yarn is further configured besides the two three-dimensional combined knitting yarns, and the third three-dimensional combined knitting yarn further forms an acute angle, so that after knitting, the third three-dimensional combined knitting yarn is equivalent to divide each grid into two meshes, thereby further making the grids be more elongated, further reducing the size of the grids, further improving the blocking capability of blood, and further avoiding the increase of aneurysm.

It should be noted that the difference between the two embodiments is that the third three-dimensional combined knitting yarn is compared with one of the first three-dimensional combinedknitting yarn 11 and the second three-dimensional combinedknitting yarn 12, and the substance of the third three-dimensional combined knitting yarn is not different, and the description thereof is not repeated herein.

In this embodiment, two three-dimensional combined knitting yarns are equivalently added, and the three-dimensional combined knitting yarns are combined to form one yarn, that is, on one hand, the number of layers to be knitted or the size of the knitted yarn is increased, on the other hand, through the arrangement of the included angle, the mesh size can be different, the larger the area of the mesh with the larger included angle is, the smaller the area of the included angle is, therefore, the mesh formed after winding is different, when the three-dimensional knitted stent is formed by the multiple layers of three-dimensional combined knitting yarns, the small mesh tends to form cutting on the large mesh, so that the mesh becomes smaller and has difference, on the one hand, the process is simpler, on the other hand, the blocking capability of blood can be improved, and blood is prevented from entering into aneurysm.

In the implementation of the application, on one hand, the small grids have smaller gaps, so that blood in the blood vessel can be blocked to prevent the blood from entering the aneurysm, and the blood can be prevented from penetrating through the grids, so that the blood is prevented from entering the aneurysm; on the other hand, so set up, the three-dimensional support of weaving that this embodiment provided, compare in the three-dimensional support of weaving among the prior art, have shape memory simultaneously, higher adherence performance, support performance, weave the direction through cooperation development material and spiral simultaneously, the third silk thread of development does not shoot the dead angle in the angiogram symptom, can improve development effect, and three silk threads can form the space, can hold the coating that the coating solution solidification formed in the space through this structure, thereby can realize better anticoagulation effect.

In this embodiment, it is equivalent to that one three-dimensional combined knitting yarn is respectively disposed on the upper layer and the lower layer of the first three-dimensional combinedknitting yarn 12 or the second three-dimensional combinedknitting yarn 12, so that on one hand, a reinforcing effect can be formed on the first three-dimensional combinedknitting yarn 12 or the second three-dimensional combinedknitting yarn 12, and on the other hand, the mesh size can be further reduced, thereby improving a blood blocking effect.

In the embodiment of the application, when the device is used as a carotid artery device, firstly, a narrow artery in a carotid artery is determined through angiography as shown in fig. 1a, then, theintroducer 400 is placed, the guide wire and theintroducer 400 are pushed to a set position (forming a certain distance with the narrow artery) behind the narrow artery, then, the three-dimensional braided stent 300 is compressed and guided into a microcatheter, the microcatheter is placed into the narrow artery along the guide wire, at the moment, the three-dimensional braided stent is pressed into the microcatheter and is in a compressed configuration, and the three-dimensional braided stent and the microcatheter are conveyed to thenarrow artery 200 in theblood vessel 100;

as shown in fig. 1b, the microcatheter is then withdrawn, the three-dimensionalwoven stent 300 is released to assume an expanded state, and the three-dimensional woven stent is expanded and then fitted to the narrowedartery 200, thereby supporting and expanding the narrowedartery 200.

As shown in fig. 1c, theintroducer 400 is then withdrawn from the blood vessel to retain the three-dimensional braided stent 300 in the blood vessel, but theintroducer 400 may be withdrawn together with the three-dimensional braided stent 300 or placed in the blood vessel in some medical scenarios, which is not limited in the present application.

Compared with the prior art, the three-dimensional woven stent at least comprises a plurality of first three-dimensional combinedwoven wires 11 and second three-dimensional combinedwoven wires 12 which are woven in a staggered mode, so that the three-dimensional woven stent is not provided with other structures, each three-dimensional combined woven wire comprises afirst silk thread 101, asecond silk thread 102 and athird silk thread 103 which are combined together, thefirst silk thread 101 comprises a shape memory material, thesecond silk thread 102 is a material with rigidity higher than a set threshold value, and thethird silk thread 103 is a material which is not transparent to X-rays, so that the three silk threads have shape memory, high adherence performance and supporting performance simultaneously, and through matching with a developing material and a spiral weaving direction, thethird silk thread 103 does not have shooting dead corners in angiography symptoms, the developing effect can be improved, gaps can be formed among the three silk threads, and the coating formed after a coating solution is solidified can be contained in the gaps through the structure, so that a better anticoagulation effect can be realized.

The second aspect of the present application further provides a medical device comprising an introducer and a three-dimensional braided stent as described in the above embodiments, the introducer being configured to introduce the three-dimensional braided stent into a blood vessel.

The medical device provided by the embodiment of the application is that the three-dimensional braided stent at least comprises a plurality of first three-dimensional combined braidedwires 11 and second three-dimensional combined braidedwires 12 which are braided in a staggered mode, so that the three-dimensional braided stent is not provided with other structures, each three-dimensional combined braided wire comprises afirst silk thread 101, asecond silk thread 102 and athird silk thread 103 which are combined together, thefirst silk thread 101 comprises a shape memory material, thesecond silk thread 102 is a material with rigidity higher than a set threshold value, and thethird silk thread 103 is an X-ray-tight material, so that the three silk threads have shape memory, high adherence performance and support performance simultaneously, meanwhile, through matching with a developing material and a spiral braiding direction, the developedthird silk thread 103 does not shoot dead corners in angiographic symptoms, the developing effect can be improved, the three silk threads can form gaps, and the three silk threads can contain coatings formed after a coating solution is cured in the gaps through the structure, so that a better anticoagulation effect can be realized.

Further, in a third aspect of the present application, there is provided a method for manufacturing a three-dimensional woven stent, including:

s1: combining the first, second and third threads to form a first three-dimensional combined braidedfilament 11 and a second three-dimensional combined braidedfilament 12; a groove gap is formed among the first silk thread, the second silk thread and the third silk thread;

s2: laying a coating solution in the groove gaps of the first three-dimensionalcombined weaving wire 11 and the second three-dimensionalcombined weaving wire 12 and curing;

s3: the solidified first three-dimensionalcombined weaving wires 11 and the solidified second three-dimensionalcombined weaving wires 12 are woven in a staggered mode to form a three-dimensional weaving support; wherein the first wire comprises a shape memory material, the second wire is a material having a stiffness strength above a set threshold, and the third wire is an X-ray opaque material.

In an alternative embodiment, regarding the structure in fig. 6, in this embodiment, the first silk thread, the second silk thread, and the third silk thread are combined to form a three-dimensional combined knitting silk, which specifically includes:

In an alternative embodiment, with respect to the structure of fig. 8, in this embodiment, the combining the first silk thread, the second silk thread, and the third silk thread to form the three-dimensional combined knitting silk includes:

winding the first and second wires around each other and extending spirally in the same direction;

Specific examples are given below to explain, for each three-dimensional combined knitting wire, firstly, a memory alloy wire and a high-strength alloy wire are knitted together through a customized tooling die to form a shape similar to a 'petal of a hemp', then the knitted alloy wires are used as core wires, a developing alloy wire is wound on the knitted alloy wires to form a 'combined alloy wire', then the 'combined alloy wire' is used as one wire, and thus 48, 72, 96 and other 'combined alloy wires' are used for knitting the three-dimensional knitted stent. And then shaping the woven three-dimensional stent by a high-temperature shaping method, finally coating a coating solution on the surface of the stent to form a coating pool in a gap groove between the filaments, so that a gap groove structure is formed between the filaments, and the coating can be arranged in the gap groove.

The above description is only exemplary of the present application and should not be taken as limiting the present application, as any modification, equivalent replacement, or improvement made within the spirit and principle of the present application should be included in the protection scope of the present application.

Claims

1. A three-dimensional woven stent comprising at least a plurality of three-dimensional combined woven filaments which are woven in a staggered manner, wherein each three-dimensional combined woven filament comprises a first filament, a second filament and a third filament which are combined together, the first filament comprises a shape memory material, the second filament is a material with rigidity and strength higher than a set threshold value, and the third filament is a material which is not transparent to X-rays; a groove gap is formed among the first silk thread, the second silk thread and the third silk thread, and a coating formed after the coating solution is solidified is arranged in the groove gap; the first silk thread, the second silk thread and the third silk thread are mutually wound and spirally extend along the same direction, the third silk thread is positioned on the outer sides of the first silk thread and the second silk thread, or the first silk thread and the second silk thread are mutually wound and spirally extend along the same direction, and the third silk thread is spirally wound on the outer side surfaces of the first silk thread and the second silk thread;

the first silk thread, the second silk thread and the third silk thread respectively comprise a first spiral section, a second spiral section and a third spiral section which are sequentially arranged along the radial direction; the helix angle of the first helical segment and the helix angle of the third helical segment are both less than the helix angle of the second helical segment for each wire, or the inner diameter of the first helical segment and the inner diameter of the third helical segment are both greater than the inner diameter of the second helical segment for each wire.

2. The three-dimensional braided stent of claim 1 wherein said first filaments include at least one indentation in a sidewall thereof extending radially of said first filaments.

3. The three-dimensional braided stent of claim 2 wherein said dimples are between 1um and 3um in width.

4. The three-dimensional braided stent of claim 2 wherein each of said dimples comprises a plurality of expanded diameter sections which expand radially along said first wires and a plurality of reduced diameter sections which reduce radially along said first wires, said expanded diameter sections and said reduced diameter sections being alternately spaced apart.

5. The three-dimensional braided stent of claim 1 wherein said first filaments include at least one indent unit on a sidewall thereof extending radially of said first filaments, each indent unit including a plurality of indent segments.

6. The three-dimensional braided stent of claim 5, wherein said plurality of indented segments comprise a plurality of radially expanded indented segments that expand radially along said first wires and a plurality of radially reduced indented segments that reduce radially along said first wires, said radially expanded indented segments and said radially reduced indented segments being alternately spaced.

7. The three-dimensional braided stent of claim 1 wherein at least two of said first, second and third wires are helically wound to define a plurality of spaced apart gaps therebetween.

8. The three-dimensional braided stent of claim 1 wherein at least two of said first filaments, said second filaments and said third filaments are helically wound to define gaps therebetween which are integrally connected in a helical direction.

9. The three-dimensional braided stent of claim 1 wherein said plurality of three-dimensional combination braided filaments comprises a plurality of first three-dimensional combination braided filaments and a plurality of second three-dimensional combination braided filaments, each of said first three-dimensional combination braided filaments being braided in a first predetermined helical direction, each of said second three-dimensional combination braided filaments being braided in a second predetermined helical direction, and an included angle formed by a straight line of said first predetermined helical direction and a straight line of said second predetermined helical direction being a right angle or an acute angle.

10. The three-dimensional braided stent of claim 9 wherein said plurality of three-dimensional combination braided filaments further comprises a plurality of third three-dimensional combination braided filaments, each of said third three-dimensional combination braided filaments being adjacent to one of said first three-dimensional combination braided filaments and braided in a third predetermined helical direction, said third predetermined helical direction being the same as said first predetermined helical direction, or an angle formed by a straight line of said third predetermined helical direction and a straight line of said first predetermined helical direction being a predetermined acute angle; or,

the plurality of three-dimensional combined knitting yarns further comprise a plurality of third three-dimensional combined knitting yarns, each third three-dimensional combined knitting yarn is close to one of the second three-dimensional combined knitting yarns and is knitted along a third preset spiral direction, the third preset spiral direction is the same as the second preset spiral direction, or an included angle formed by a straight line of the third preset spiral direction and a straight line of the second preset spiral direction is a preset acute angle.

13. The three-dimensional braided stent of claim 1 wherein the material forming said first wires comprises nitinol; and/or the material forming the second wire comprises a cobalt chromium alloy or stainless steel; and/or the material forming the third wire comprises a platinum alloy or a gold alloy.

14. A medical device comprising an introducer and the three-dimensional braided stent of any one of claims 1-13, the introducer being configured to introduce the three-dimensional braided stent into a blood vessel.

15. A method for manufacturing a three-dimensional woven stent is characterized by comprising the following steps:

the solidified first three-dimensional combined weaving silk and the solidified second three-dimensional combined weaving silk are woven in a staggered mode to form a three-dimensional weaving support; wherein the first wire comprises a shape memory material, the second wire is a material having a stiffness strength above a set threshold, and the third wire is an X-ray opaque material;

combining the first, second, and third filaments to form a three-dimensional combined braided filament, comprising:

the first silk thread, the second silk thread and the third silk thread are mutually wound and spirally extend along the same direction to form a three-dimensional combined knitting silk, and the third silk thread is formed on the outer sides of the first silk thread and the second silk thread in the process of forming the three-dimensional combined knitting silk; or, the combining the first, second, and third filaments to form a three-dimensional combined braided filament includes:

spirally winding the third silk thread on the outer side surfaces of the first silk thread and the second silk thread to form a three-dimensional combined braided silk; the first silk thread, the second silk thread and the third silk thread respectively comprise a first spiral section, a second spiral section and a third spiral section which are sequentially arranged along the radial direction; the helix angle of the first helical segment and the helix angle of the third helical segment are both less than the helix angle of the second helical segment for each wire, or the inner diameter of the first helical segment and the inner diameter of the third helical segment are both greater than the inner diameter of the second helical segment for each wire.