Transarticular vascular stent and method of making same

By using segmented design and electrospinning technology to fabricate cross-articular vascular stents, the problem of insufficient adaptability of existing stents in the lower limb arterial region has been solved. This has enabled the stent to achieve compliance and fatigue resistance under complex mechanical deformation, reducing restenosis and fracture.

CN121015356BActive Publication Date: 2026-02-13POLYREY MEDICAL TECH SUZHOU CO LTD
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Patent Information

Application Number
CN202511576723.0
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-10-31
Publication Date
2026-02-13
Estimated Expiration
2045-10-31

AI Technical Summary

Technical Problem

Existing stent designs cannot take into account the differentiated needs of different regions of the lower limb arteries, making them prone to restenosis or breakage under mechanical deformation in the FPA region. Existing stents cannot simultaneously maintain compliance and fatigue resistance under axial compression, torsion and bending.

Method used

The stent adopts a transarticular vascular design, comprising a first part and a second part. The first part consists of multiple first stent rings and a covering membrane, and the second part consists of multiple second stent rings and a connecting membrane. The covering membrane and connecting membrane are prepared by electrospinning technology. The stent rings are made of absorbable materials and coated with sustained-release drugs. The design of the stent rings and connecting membranes is adapted to the mechanical deformation of different regions.

Benefits of technology

It effectively avoids stent breakage and restenosis, reduces the probability of secondary surgery, maintains vascular patency, adapts to the complex mechanical deformation of lower limb arteries, and reduces mechanical stress stimulation on the arterial wall.

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Abstract

The present application relates to a kind of transarticular vascular stents and its preparation method, transarticular vascular stent includes the first part and second part distributed along the axial direction of transarticular vascular stent;First part includes multiple first stent rings spaced apart along the axial direction of transarticular vascular stent and independent of each other and the whole surface film fixedly arranged on multiple first stent rings;Wherein, from proximal end to distal end, the distance between adjacent two first stent rings gradually increases;Second part includes multiple second stent rings spaced apart along the axial direction of transarticular vascular stent and independent of each other and multiple rows of connecting film groups sequentially arranged along the axial direction of transarticular vascular stent;Each row of connecting film groups includes multiple connecting membranes uniformly distributed along the circumferential direction of transarticular vascular stent, and both ends of each connecting membrane are respectively fixedly connected with adjacent two second stent rings;The width of the rod forming first stent ring is greater than the width of the rod forming second stent ring.
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Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a transarticular vascular stent and a preparation method thereof. BACKGROUND

[0002] This section is intended to provide background or context to the embodiments of the application. The description herein does not constitute admission of prior art.

[0003] Peripheral arterial disease (PAD) is a common cardiovascular disease, which often occurs in lower extremity arteries, and the femoro-popliteal artery (FPA) is the main affected site. FPA is a key pathway for blood supply to the lower extremities, and its anatomical structure includes branches such as common femoral artery, superficial femoral artery, adductor hiatus, popliteal artery, etc. FPA is responsible for supplying blood to the lower extremity tissues, but under pathological conditions (such as atherosclerosis), it is prone to chronic blood flow obstruction, leading to PAD.

[0004] The treatment methods for PAD include drug therapy, physical exercise and endovascular intervention. Among them, stent implantation is a minimally invasive endovascular treatment method, which implants a permanent stent (such as a metal mesh) into the blocked artery through balloon angioplasty to restore blood flow. Compared with traditional bypass surgery, stent implantation has the advantages of short recovery time and low invasiveness, so it is increasingly widely used in clinical practice.

[0005] However, the unique biomechanical environment of FPA poses a severe challenge to the durability of the stent. Lower extremity arteries undergo complex mechanical deformation during daily activities (such as walking, sitting, and squatting), including axial compression / stretching (axial compression / stretching rate of about 7%), torsion (angle up to 70°) and bending (angle up to 110°), especially in the adductor hiatus and popliteal artery regions. These deformations will cause the stent to bear periodic stress, leading to stent fracture, plastic deformation or in-stent restenosis (ISR). Clinical data shows that the incidence of ISR is high, and often requires repeated surgery, which is a major difficulty in the treatment of PAD.

[0006] Existing stent designs often cannot meet the differentiated needs of different regions of FPA. For example, the stent shown in FIG. 1A is a straight stent, which is not suitable for the complex mechanical deformation of FPA. The stent shown in FIG. 1B is a bifurcated stent, which is not suitable for the adductor hiatus region. The stent shown in FIG. 1C is a bifurcated stent with a twist, which is not suitable for the popliteal artery region. Figure 1As shown, different parts of the lower limb artery (such as A, B, C, D, D is divided into P1, P2, P3) have specific requirements for the performance of the stent: for example, part A requires accurate positioning, part B requires high radial support force, part C / P1 requires flexibility and anti-torsion, part P2 requires flexibility, and part P3 requires small diameter and low chronic outward force (COF). The existing stent usually only performs well in a single performance, but lacks comprehensive adaptability, leading to easy restenosis or fracture after long-term implantation.

[0007] Therefore, there is an urgent need in the art for a new FPA stent that can adapt to various mechanical deformations of the lower limb artery, maintain excellent compliance and fatigue resistance in bending, twisting, compression and other modes, while minimizing mechanical stress stimulation to the arterial wall and maximizing lumen maintenance. The present application is aimed at the above problems and proposes a transarticular vascular stent to solve the shortcomings of the prior art. SUMMARY

[0008] The purpose of the present application is to provide a transarticular vascular stent with a different structure and a preparation method thereof.

[0009] To achieve the above-mentioned purpose, the technical scheme adopted by the present application is:

[0010] The first aspect of the present application relates to a transarticular vascular stent having an expanded state and a contracted state, the inner diameter of the transarticular vascular stent in the expanded state being larger than the inner diameter of the transarticular vascular stent in the contracted state; the transarticular vascular stent comprises a first part and a second part distributed along the axial direction of the transarticular vascular stent, wherein the first part is located at the proximal end and the second part is located at the distal end;

[0011] The first part comprises a plurality of first stent rings arranged at intervals along the axial direction of the transarticular vascular stent and independent of each other, and a full-surface covering film fixedly arranged on the plurality of first stent rings; wherein from the proximal end to the distal end, the distance between adjacent two first stent rings gradually increases;

[0012] The second part comprises a plurality of second stent rings arranged at intervals along the axial direction of the transarticular vascular stent and independent of each other, and a plurality of rows of connecting film groups arranged in sequence along the axial direction of the transarticular vascular stent; each row of connecting film groups comprises a plurality of connecting films uniformly distributed along the circumferential direction of the transarticular vascular stent, and both ends of each connecting film are fixedly connected with adjacent two second stent rings, respectively;

[0013] The width of the rod forming the first stent ring is greater than the width of the rod forming the second stent ring.

[0014] According to some embodiments, the distance between any two adjacent first stent rings at the proximal end is 0.2-0.5mm, such as 0.2mm, 0.25mm, 0.3mm, 0.35mm, 0.4mm, 0.45mm, 0.5mm, etc., and the distance between any two adjacent first stent rings at the distal end is 1-3mm, such as 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3mm, etc.

[0015] According to some embodiments, the distance between any two adjacent second stent rings is equal; the distance between any two adjacent first stent rings, the distance between any two adjacent first and second stent rings, and the distance between any two adjacent first stent rings at the distal end are equal.

[0016] According to some embodiments, the width of the rod of the first stent ring is 0.27-0.3mm, such as 0.27mm, 0.28mm, 0.29mm, 0.3mm, etc., and the width of the rod of the second stent ring is 0.2-0.24mm, such as 0.2mm, 0.21mm, 0.22mm, 0.23mm, 0.24mm, etc.

[0017] According to some embodiments, the transarticular vascular stent is made of absorbable material; the first stent ring and the second stent ring are respectively a braided ring or a cut ring.

[0018] According to some embodiments, the first stent ring and the second stent ring are respectively a braided ring or a cut ring.

[0019] According to some embodiments, the width of the connecting film is 0.3-0.64mm.

[0020] According to some embodiments, the number of connecting films in each group of connecting films is 2-3.

[0021] According to some embodiments, the connecting films in multiple groups of connecting films are arranged in multiple rows in the axial direction of the transarticular vascular stent, and each connecting film extends in the same clockwise direction.

[0022] According to some embodiments, each group of connecting films further comprises a stent ring film consistent with the shape of the second stent ring, and the stent ring film, the connecting film, and the covering film are integrally arranged.

[0023] According to some embodiments, the two ends of the connecting film are respectively fixedly connected with the nearest peak and valley in the two adjacent stent ring films.

[0024] Further, the stent ring film, the connecting film and the covering film are formed by electrospinning; and / or the material of the stent ring film, the connecting film and the covering film is absorbable material.

[0025] Further, the pore size of the film formed by electrospinning is below 5 microns.

[0026] Further, the surface of the stent ring film, the connecting film and the covering film is coated with a sustained-release drug coating.

[0027] According to some embodiments, the joint includes a knee joint or an elbow joint.

[0028] The second aspect of the present application provides a preparation method of the trans-joint vascular stent as described above, which includes the following steps:

[0029] (1) preparing a first stent ring and a second stent ring;

[0030] (2) preparing a film by electrospinning;

[0031] (3) cutting the film to form the covering film and the plurality of connecting film groups;

[0032] (4) fixedly connecting the cut film, the first stent ring and the second stent ring to obtain the trans-joint vascular stent.

[0033] The third aspect of the present application provides a preparation method of the trans-joint vascular stent as described above, which includes the following steps:

[0034] (1) preparing a first stent ring and a second stent ring;

[0035] (2) preparing a film by electrospinning;

[0036] (3) fixedly connecting the film, the first stent ring and the second stent ring;

[0037] (4) cutting the film at the corresponding position after the fixed connection in step (3) to obtain the trans-joint vascular stent.

[0038] Due to the use of the above technical solutions, the present application has the following advantages compared with the prior art:

[0039] The present application adopts different design structures for different sections of the transarticular vascular stent, so that the transarticular vascular stent can adapt to various mechanical deformations of the transarticular artery, maintain excellent compliance and fatigue resistance under bending, twisting, compression and other modes, minimize the mechanical stress stimulation to the arterial wall, and maximize the lumen maintenance, thereby effectively avoiding the occurrence of stent fracture, plastic deformation or in-stent restenosis, and reducing the probability of secondary surgery. BRIEF DESCRIPTION OF DRAWINGS

[0040] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0041] Figure 1 It is a partitioned schematic diagram of different parts of lower limb artery.

[0042] Figure 2 It is a perspective view of the transarticular vascular stent.

[0043] Figure 3 It is a front view of the transarticular vascular stent.

[0044] Figure 4 It is a front view of the braided ring.

[0045] Figure 5 It is a perspective view of the braided ring.

[0046] Figure 6 It is a front view of the cutting ring with a developing ring.

[0047] Figure 7 It is a perspective view of the cutting ring without a developing ring.

[0048] Figure 8 It is an unfolded state diagram of the cut film.

[0049] Figure 9 It is a front view of the cut film.

[0050] Figure 10 It is an unfolded state diagram of the stent ring film.

[0051] Figure 11 It is a perspective view of the film obtained by electrospinning.

[0052] Figure 12 It is a perspective view of the film obtained by electrospinning and fixed with the first stent ring and the second stent ring in one embodiment.

[0053] Figure 13This is a front view of a membrane obtained by electrospinning, fixed to a first support ring and a second support ring, according to one embodiment.

[0054] Figure 14 A schematic diagram of a transarticular vascular stent in a blood vessel. Figure 1 ;

[0055] Figure 15 A schematic diagram of a transarticular vascular stent in a blood vessel. Figure 2 . Detailed Implementation

[0056] In the following description, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments can be modified in various ways without departing from the spirit or scope of the embodiments of this application. Therefore, the drawings and description are considered to be exemplary in nature and not restrictive.

[0057] In the description of the embodiments of this application, it should be understood that the terms "proximal end" and "distal end" refer to the end of a blood vessel that is closer to the heart and the end that is farther from the heart. "Axial direction of the vascular stent" refers to the linear dimension along the longitudinal axis of the stent, in which compression or stretching deformation can occur. "Circumferential direction of the vascular stent" refers to the annular dimension surrounding the longitudinal axis of the stent, usually associated with the radial direction. "Complete coating" means that the coating is a single, intact membrane, without any pores, except for the micropores created by the electrospinning process.

[0058] The orientations used in this application are for the convenience of describing the embodiments of this application and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the embodiments of this application.

[0059] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the embodiments of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0060] In the embodiments of this application, unless otherwise expressly specified and limited, the term "inside" or "outside" the second feature may include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "inside" the second feature means that the first feature is closer to the center line than the second feature. "Outside" the second feature means that the first feature is farther from the center line than the second feature.

[0061] The following disclosure provides many different embodiments or examples for implementing different structures of the present application. For the purpose of simplifying the present application, the components and arrangements of specific examples are described in the following. Of course, they are only examples and the purpose is not to limit the present application. In addition, the present application can repeat reference numerals and / or reference letters in different examples. Such repetition is for the purpose of simplification and clarity, and does not in itself indicate a relationship between the various embodiments and / or arrangements discussed. In the present application, the features with the same name are the same in structural size unless specifically stated.

[0062] The embodiments of the present application are described in detail below with reference to the accompanying drawings.

[0063] Figures 2 to 15 A transarticular vascular stent is shown, which has an expanded state and a contracted state, and the inner diameter of the transarticular vascular stent in the expanded state is larger than that in the contracted state. Wherein, Figure 2 and Figure 3 A schematic diagram of the transarticular vascular stent in the expanded state is shown. The transarticular vascular stent can be compressed in the delivery sheath by conventional methods and released by conventional methods, for example, the transarticular vascular stent can be a self-expanding stent, that is, the transarticular vascular stent can be inflated to the expanded state by itself when it is released from the delivery sheath; or it can be a balloon dilatation stent, that is, the transarticular vascular stent is loaded on the balloon, and the transarticular vascular stent is forced to expand to the expanded state by expanding the balloon. Figure 14 and Figure 15 A schematic diagram of the transarticular vascular stent in the expanded state is shown. The transarticular vascular stent can be compressed in the delivery sheath by conventional methods and released by conventional methods, for example, the transarticular vascular stent can be a self-expanding stent, that is, the transarticular vascular stent can be inflated to the expanded state by itself when it is released from the delivery sheath; or it can be a balloon dilatation stent, that is, the transarticular vascular stent is loaded on the balloon, and the transarticular vascular stent is forced to expand to the expanded state by expanding the balloon.

[0064] As shown in Figure 2 and Figure 3 The transarticular vascular stent includes a first part 1 and a second part 2 distributed along the axial direction of the transarticular vascular stent. Wherein, the first part 1 is located at the proximal end, and the second part 2 is located at the distal end.

[0065] The first part 1 includes a plurality of first stent rings 11 and a covering film 12. The plurality of first stent rings 11 are arranged at intervals along the axial direction of the transarticular vascular stent and are independent of each other. That is, the plurality of first stent rings 11 are separated from each other, and the relative fixation of the plurality of first stent rings 11 is achieved by the covering film 12. In addition to the covering film 12, there is no other connecting structure between the plurality of first stent rings 11. The covering film 12 is a whole dense film, and no large hole is provided on it, so as to prevent cell ingrowth and avoid excessive proliferation of endothelial cells. The covering film 12 is fixedly arranged inside and / or outside the plurality of first stent rings 11, Figure 2 and Figure 3 The covering film 12 is fixedly arranged inside the plurality of first stent rings 11 as shown in

[0066] like Figure 3 As shown, the distance between two adjacent first stent rings 11 gradually increases from the proximal end to the distal end. In some embodiments, the distance L1 between two adjacent first stent rings 11 located at the proximal end (i.e., Figure 3 The distance between the two adjacent first stent rings 11 at the far right end of the first part 1 is 0.2-0.5 mm, and the distance L2 between the two adjacent first stent rings 11 at the distal end (i.e., Figure 3 The distance between two adjacent first stent rings 11 at the leftmost end of the first part 1 is 1-3 mm. This distance refers to the distance between the trough of the right stent ring and the peak of the left stent ring within two adjacent stent rings. Gradually increasing the distance between adjacent first stent rings 11 gradually increases the compliance of the first part 1 and provides lower COF forces. The width W1 of the first stent ring 11's strut is 0.27-0.3 mm. Controlling the proximal distance of the first stent ring 11 and coordinating the strut width provides higher radial support to meet the support requirements of the non-motorized proximal region of the artery, such as the support requirements of the non-motorized proximal region of superficial arteries.

[0067] Part 2 includes multiple second stent rings 21 and multiple rows of connecting membrane assemblies. The multiple second stent rings 21 are spaced apart along the axial direction of the transarticular vascular stent and are independent of each other. That is, the multiple second stent rings 21 are separated from each other, and are relatively fixed by connecting membrane assemblies; there are no other connecting structures between the multiple second stent rings 21. Multiple rows of connecting membrane assemblies are arranged sequentially along the axial direction of the transarticular vascular stent. A row of connecting modules is arranged between two adjacent second stent rings 21, and another row of connecting modules is arranged between adjacent second stent rings 21 and first stent rings 11. That is, adjacent second stent rings 21 and first stent rings 11 are fixedly connected by this row of connecting membrane assemblies. Alternatively, adjacent second stent rings 21 and first stent rings 11 are fixedly connected by a covering membrane 12.

[0068] Each row of the connecting membrane group comprises a plurality of connecting membranes 22 uniformly distributed along the circumference of the transarticular vascular stent, and two ends of each connecting membrane 22 are fixedly connected with two adjacent second stent rings 21. The number of connecting membranes 22 in each row of the connecting membrane group is 2-3. The second part 2 is designed as a hollow design by connecting the second stent rings 21 through the plurality of connecting membranes 22, which provides excellent flexibility to meet the movement area requirements of the transarticular segment, and the hollow design can avoid occlusion of the collateral after long-term implantation. For example, the movement area from the proximal femoral popliteal artery to the popliteal artery P3 segment through the knee joint has the largest arterial deformation amount when a person walks, sits, and squats, and therefore has the highest requirement for the flexibility of the stent. At the same time, there are many collaterals around the artery across the knee joint, and the hollow design can avoid occlusion of the collateral after long-term implantation. In some embodiments, the width W3 of the connecting membrane 22 is 0.3-0.64 mm, which can ensure the connecting strength and avoid breakage while minimizing the impact on the torsional performance of the second part 2.

[0069] As shown in Figure 3 , the distance between any two adjacent second stent rings 21 is equal; the distance L3 between the adjacent second stent rings 21, the distance L4 between the adjacent first stent ring 11 and the second stent ring 21, and the distance L2 between the adjacent first stent rings 11 at the distal end are all equal. The width W1 of the rod forming the first stent ring 11 is greater than the width W2 of the rod forming the second stent ring 21. The width W2 of the rod of the second stent ring 21 is 0.2-0.24 mm. Thus, more appropriate support force and flexibility are provided.

[0070] The first stent ring 11 and the second stent ring 21 are respectively a woven ring or a cut ring. As shown in Figure 4 and Figure 5 , the structure of the woven ring is shown, and as shown in Figure 6 and Figure 7 , the structure of the cut ring is shown, wherein Figure 6 the cut ring is provided with a developing ring to facilitate identification of the position of the transarticular vascular stent in the blood vessel. Whether it is a woven ring or a cut ring, it contains periodically arranged peaks and valleys. As shown in Figure 3 , the plurality of first stent rings 11 and the plurality of second stent rings 21 are aligned with peaks and valleys.

[0071] The connecting membranes 22 in the multiple rows of connecting membrane groups are arranged in multiple rows in the axial direction of the transarticular vascular stent, and each connecting membrane 22 extends in the same clockwise direction. The angle between the extension direction of the connecting membrane 22 and the axial direction of the transarticular vascular stent is an acute angle. As shown in Figure 3As shown in FIG. 2, each group of connecting membranes contains two connecting membranes 22, one of which is aligned in the axial direction of the transarticular vascular stent, and the other of which is also aligned in the axial direction of the transarticular vascular stent, thereby forming two rows of connecting membranes 22 arranged on opposite sides of the transarticular vascular stent.

[0072] As shown in FIG. 2, each group of connecting membranes contains two connecting membranes 22, one of which is aligned in the axial direction of the transarticular vascular stent, and the other of which is also aligned in the axial direction of the transarticular vascular stent, thereby forming two rows of connecting membranes 22 arranged on opposite sides of the transarticular vascular stent. Figure 8 and Figure 9 As shown in FIG. 2, each group of connecting membranes contains two connecting membranes 22, one of which is aligned in the axial direction of the transarticular vascular stent, and the other of which is also aligned in the axial direction of the transarticular vascular stent, thereby forming two rows of connecting membranes 22 arranged on opposite sides of the transarticular vascular stent.

[0073] In some embodiments, the stent ring membrane 23, the connecting membrane 22, and the covering membrane 12 are formed by electrospinning, Figure 11 As shown in FIG. 2, each group of connecting membranes contains two connecting membranes 22, one of which is aligned in the axial direction of the transarticular vascular stent, and the other of which is also aligned in the axial direction of the transarticular vascular stent, thereby forming two rows of connecting membranes 22 arranged on opposite sides of the transarticular vascular stent. Figure 10 As shown in FIG. 2, each group of connecting membranes contains two connecting membranes 22, one of which is aligned in the axial direction of the transarticular vascular stent, and the other of which is also aligned in the axial direction of the transarticular vascular stent, thereby forming two rows of connecting membranes 22 arranged on opposite sides of the transarticular vascular stent.

[0074] In some embodiments, the transarticular vascular stent is made of absorbable materials, including but not limited to high-molecular polylactic acid, absorbable magnesium alloy, etc. The stent ring membrane 23, the connecting membrane 22, and the covering membrane 12 are also made of absorbable materials, including but not limited to PLA, PDLA, PDO, PLGA, etc. so that the transarticular vascular stent can gradually degrade after the completion of endothelialization.

[0075] In some embodiments, the surface of the stent ring membrane 23, the connecting membrane 22 and the covering membrane 12 is coated with a sustained-release drug coating, the active substance in the sustained-release drug coating includes but is not limited to everolimus, paclitaxel, etc., and the sustained-release matrix includes but is not limited to PDLA, PDLLA, PLDA, PLGA, etc. The sustained-release drug coating can inhibit intimal hyperplasia and improve long-term patency rate.

[0076] The trans-articular vascular stent is developed for lower extremity arteries, but is also applicable to upper extremity arteries. The joint includes a knee joint or an elbow joint, that is, the trans-articular vascular stent can be applicable to a vascular artery across a knee joint position, and can also be applicable to a vascular artery across an elbow joint.

[0077] The trans-articular vascular stent can be prepared by the following method:

[0078] Method one:

[0079] (1) The first stent ring 11 and the second stent ring 21 are prepared by a braiding machine or a laser cutting heat treatment polishing process;

[0080] (2) The membrane is prepared by electrospinning;

[0081] (3) The membrane is cut by a femtosecond laser cutting machine to form the covering membrane 12 and the plurality of rows of connecting membrane groups;

[0082] (4) The cut membrane is arranged inside or outside the first stent ring 11 and the second stent ring 21, and is fixed and connected by a hot melting or biological glue bonding method to obtain the trans-articular vascular stent.

[0083] Method two:

[0084] (1) The first stent ring 11 and the second stent ring 21 are prepared by a braiding machine or a laser cutting heat treatment polishing process;

[0085] (2) The membrane is prepared by electrospinning;

[0086] (3) The membrane is arranged inside the first stent ring 11 and the second stent ring 21, as shown in Figure 12 and 13 , and is fixed and connected by a hot melting or biological glue bonding method;

[0087] (4) The membrane is cut by a femtosecond laser cutting machine at the corresponding position after the fixed connection in step 3 to obtain the trans-articular vascular stent.

[0088] The cross-joint vascular stent adopts a sectional design, and specific designs are performed on two sections respectively to meet the mechanical property changes of different regions of the cross-joint vascular, to reduce mechanical stress stimulation to the vascular intima as much as possible, to reduce the long-term restenosis rate to the minimum, and the cross-joint vascular stent has a very low fracture rate, and after 400 million times of in-vitro fatigue pulsation cycles and 10 million times of bending and torsion experiments, the fracture rate is "0".

[0089] The above examples are only for illustrating the technical concept and characteristics of the present application, and the purpose is to enable those skilled in the art to understand the content of the present application and to implement it, and cannot limit the protection scope of the present application. Any equivalent changes or modifications made according to the spirit and essence of the present application shall be covered within the protection scope of the present application.

Claims

1. A transarticular vascular stent having an expanded state and a collapsed state, the transarticular vascular stent having an inner diameter in the expanded state that is greater than an inner diameter in the collapsed state; characterized by: The transarticular vascular stent comprises a first part (1) and a second part (2) distributed along the axial direction of the transarticular vascular stent, wherein the first part (1) is located at the proximal end and the second part (2) is located at the distal end; The first part (1) comprises a plurality of first stent rings (11) arranged at intervals along the axial direction of the transarticular vascular stent and independent of each other, and an integral covering film (12) fixedly arranged on the plurality of first stent rings (11); wherein the distance between adjacent two first stent rings (11) gradually increases from the proximal end to the distal end; The second part (2) comprises a plurality of second stent rings (21) arranged at intervals along the axial direction of the transarticular vascular stent and independent of each other, and a plurality of rows of connecting film groups arranged in sequence along the axial direction of the transarticular vascular stent; each row of connecting film groups comprises a plurality of connecting films (22) uniformly distributed along the circumferential direction of the transarticular vascular stent, and both ends of each connecting film (22) are fixedly connected with adjacent two second stent rings (21), respectively; The width of the rod forming the first stent ring (11) is greater than the width of the rod forming the second stent ring (21); The first part (1) and the second part (2) are connected by a row of connecting film groups or by the covering film (12).

2. The trans-junction vascular stent of claim 1, wherein: The distance between adjacent two first stent rings (11) located at the proximal end is 0.2-0.5mm, and the distance between adjacent two first stent rings (11) located at the distal end is 1-3mm.

3. The trans-junction vascular stent of claim 1, wherein: The distance between any adjacent two second stent rings (21) is equal; the distance between adjacent two second stent rings (21), the distance between adjacent first stent ring (11) and second stent ring (21), and the distance between adjacent two first stent rings (11) located at the distal end are all equal.

4. The trans-junction vascular stent of claim 1, wherein: The width of the rod of the first stent ring (11) is 0.27-0.3mm, and the width of the rod of the second stent ring (21) is 0.2-0.24mm.

5. The trans-junction vascular stent of claim 1, wherein: The transarticular vascular stent is made of absorbable material; the first stent ring (11) and the second stent ring (21) are respectively a woven ring or a cut ring.

6. The trans-junction vascular stent of claim 1, wherein: The plurality of first stent rings (11) and the plurality of second stent rings (21) are all peak-to-peak aligned and valley-to-valley aligned; the angle between the extension direction of the connecting film (22) and the axial direction of the transarticular vascular stent is an acute angle.

7. The trans-junction vascular stent of claim 1, wherein: The width of the connecting film (22) is 0.3-0.64mm.

8. The trans-junction vascular stent of claim 1, wherein: The number of connecting films (22) in each row of connecting film groups is 2-3.

9. The trans-junction vascular stent of claim 1, wherein: The connecting films (22) in the plurality of rows of connecting film groups are arranged into multiple rows in the axial direction of the transarticular vascular stent, and each connecting film (22) extends in the same clockwise direction.

10. The trans-junction vascular stent of claim 1, wherein: Each row of connecting film groups further comprises a stent ring film (23) consistent with the shape of the second stent ring (21), and the stent ring film (23), the connecting film (22), and the covering film (12) are integrally arranged.

11. The trans-junction vascular stent of claim 10, wherein: Both ends of the connecting film (22) are fixedly connected with the nearest peak and valley of adjacent two stent ring films (23), respectively.

12. The trans-junction vascular stent of claim 10, wherein: The stent ring membrane (23), the connecting membrane (22) and the covering membrane (12) are formed by electrospinning; and / or the stent ring membrane (23), the connecting membrane (22) and the covering membrane (12) are made of absorbable material.

13. The trans-junction vascular stent of claim 12, wherein: The pore size of the membrane formed by electrospinning is below 5 microns.

14. The trans-junction vascular stent of claim 10, wherein: The stent ring membrane (23), the connecting membrane (22) and the covering membrane (12) are coated with a sustained-release drug coating.

15. The trans-junction vascular stent of claim 1, wherein: The joint includes a knee joint or an elbow joint.

16. A method of making a trans-artery stent as claimed in any one of claims 1 to 15, characterized by: It includes the following steps: (1) preparing a first stent ring (11) and a second stent ring (21); (2) preparing a membrane by electrospinning; (3) cutting the membrane to form the covering membrane (12) and the multiple rows of connecting membrane groups; (4) fixing and connecting the cut membrane, the first stent ring (11) and the second stent ring (21) to obtain the transarticular vascular stent.

17. A method of making a trans-artery stent as claimed in any one of claims 1 to 15, characterized by: It includes the following steps: (1) preparing a first stent ring (11) and a second stent ring (21); (2) preparing a membrane by electrospinning; (3) fixing and connecting the membrane, the first stent ring (11) and the second stent ring (21); (4) cutting the membrane fixed and connected in step (3) at the corresponding positions to obtain the transarticular vascular stent.

Citation Information

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