WO2024067402A1

WO2024067402A1 - Vascular stent

Info

Publication number: WO2024067402A1
Application number: PCT/CN2023/120749
Authority: WO
Inventors: 吴丽萍; 李�真; 张�雄; 詹欣宇
Original assignee: 深圳市先健纬康科技有限公司
Priority date: 2022-09-30
Filing date: 2023-09-22
Publication date: 2024-04-04
Also published as: CN117838403A

Abstract

The present invention relates to a vascular stent, comprising a stent main body. The stent main body comprises a plurality of main body wave loops. The main body wave loop comprises at least two wave crests and/or wave troughs with different heights. The main body wave loop comprises a first wave loop and a second wave loop. The first wave loop and the second wave loop have a phase difference, so that a plurality of wave troughs of the first wave loop are distributed relative to a plurality of wave crests of the second wave loop. By means of arranging the plurality of main body wave loops, the plurality of wave troughs of the first wave loop of the main body wave loop are distributed relative to the plurality of wave crests of the second wave loop, and/or a plurality of wave crests of the first wave loop are distributed relative to a plurality of wave troughs of the second wave loop, so that the wave crests and the wave troughs are abutted against each other and limited when the stent is compressed. Therefore, the stent is uniformly compressed as a whole to avoid excessive shrinkage, thereby avoiding a forward jump during release. The excessive torsion of the stent during compression and release can also be avoided when the wave crests and the wave troughs are staggered.

Description

Stent

Technical Field

The present invention relates to the technical field of interventional medical devices, and in particular to a vascular stent.

Background technique

From the 1970s to today, vascular interventional treatment technology has been booming and rapid. Interventional treatment is to introduce puncture needles, special catheters, guide wires and other precision instruments into the blood vessels in the body through percutaneous puncture under the guidance of medical imaging equipment (angiography, fluoroscopy, CT, MR, B-ultrasound, etc.) to perform minimally invasive diagnosis and treatment of diseases. Vascular interventional technology can effectively treat vascular diseases, with the advantages of less trauma, low reaction, and fast recovery. It also has targeted characteristics, which can effectively treat some patients who cannot tolerate surgery or lose the opportunity for surgery or are drug-resistant. In some areas, it has replaced surgery as the preferred treatment method. Vascular stents are an indispensable part of stent implantation. The bare stent is usually used to dilate and recanalize narrowed and occluded blood vessels or cavities, while the vascular stent is mainly used to dilate the isolation of diseased blood vessels such as aneurysms and dissections. The function of both is to restore normal blood flow to the diseased blood vessels.

The steps of vascular stent implantation are usually as follows: first perform puncture, then insert the vascular sheath to establish the channel, and insert the guide wire to establish the track. Then confirm the location, diameter and length of the lesion area through angiography, and select the stent and delivery device of the corresponding specifications. Then position the stent through CT and release the stent to the lesion location. Through the self-expansion/balloon expansion of the stent, the lumen of the stenosis segment is expanded or the lesion tumor is isolated, and the blood supply function is restored. Finally, the delivery device is withdrawn and the postoperative angiography is performed.

In actual clinical surgery, for ordinary stents, when the stent is compressed, it is compressed radially and axially at the same time, and its skeleton is close to each other, which is prone to excessive twisting or shortening, resulting in forward jump or large twisting due to expansion rebound during release. In other words, during the release process, due to the structural problems of the device itself, the stent will jump forward or shift during the release process, which will lead to surgical failure and need Compensating by placing a second stent or performing a surgical operation will greatly increase the risk of surgery. In order to improve the defect of possible displacement during the stent release process, it is particularly important to develop a vascular stent that can be released stably.

Summary of the invention

Based on this, the present invention provides a vascular stent to improve the problem of displacement that may occur during the stent release process.

A vascular stent comprises a stent body, the stent body comprises a plurality of main wave coils, the main wave coils comprise at least two wave crests and/or wave troughs of different heights, the main wave coils comprise a first wave coil and a second wave coil, the first wave coil and the second wave coil have a phase difference, so that the plurality of wave troughs of the first wave coil are distributed relative to the plurality of wave crests of the second wave coil, and/or the plurality of wave crests of the first wave coil are distributed relative to the plurality of wave troughs of the second wave coil, and/or the plurality of wave crests of the first wave coil are distributed relative to the plurality of wave troughs of the second wave coil.

In one embodiment, the first wave circle includes a plurality of first waves and second waves that are continuously and alternately distributed, the first wave and the second wave have different wave heights, the first wave includes a first wave bar and a second wave bar, the second wave includes a third wave bar and a fourth wave bar, a high wave peak is formed between the first wave bar and the second wave bar, a low wave peak is formed between the third wave bar and the fourth wave bar, a high wave trough is formed between the first wave bar and the adjacent fourth wave bar, and a low wave trough is formed between the second wave bar and the third wave bar.

In one embodiment, the second wave loop has the same structure as the first wave loop, the low wave valley of the first wave loop corresponds to the low wave peak of the second wave loop, and the high wave valley of the first wave loop corresponds to the high wave peak of the second wave loop.

In one embodiment, the plurality of low wave valleys of the first wave ring and the plurality of high wave peaks of the adjacent second wave ring are located at the same position in the axial direction.

In one embodiment, the axial position of the high wave peak of the second wave ring is between the axial positions of the high wave trough and the low wave trough of the first wave ring.

In one embodiment, the first wave loop and the second wave loop are distributed obliquely.

In one of the embodiments, two end wave circles are further included, wherein the end wave circles include a proximal wave circle and a distal wave circle, the wave crests on the proximal side of the proximal wave circle are flush, and the wave troughs on the distal side of the distal wave circle are flush.

In one embodiment, a plurality of regions are included between the first wave ring and the second wave ring, and the areas of the plurality of regions are equal.

In one embodiment, a plurality of connection points are provided between the first wave circle and the second wave circle, wherein the connection points are located between the high wave valley of the first wave circle and the high wave peak of the second wave circle, and at least two of the low wave peaks of the second wave circles are included between adjacent connection points.

In one embodiment, the first wave ring and the second wave ring are different wave bands on one wave ring, and the wave ring is distributed in a spiral shape as a whole.

The vascular stent provided by the present invention is provided with a plurality of main wave coils, wherein the main wave coils include at least two wave crests and/or wave troughs of different heights, and the main wave coils include a first wave coil and a second wave coil, wherein the first wave coil and the second wave crest have a phase difference, so that the plurality of wave troughs of the first wave coil are distributed relative to the plurality of wave crests of the second wave coil, and/or the plurality of wave crests of the first wave coil are distributed relative to the plurality of wave troughs of the second wave coil, so that when the stent is compressed, the wave crests and troughs abut against each other to limit the position, so that the stent is uniformly compressed as a whole, avoiding excessive shortening and thus forward jumping when released, and the stent can avoid excessive twisting when compressed and released by staggered wave crests and troughs.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic structural diagram of a vascular stent in a first embodiment of the present invention;

FIG2 is a schematic structural diagram of a first wave coil of a vascular stent in a first embodiment of the present invention;

3 is a schematic diagram showing the positions of the first wave coil and the second wave coil of the vascular stent in the first embodiment of the present invention;

FIG4 is a schematic diagram of the surrounding areas of the first wave coil and the second wave coil of the vascular stent in the first embodiment of the present invention;

FIG5 is a schematic diagram of the overall state of the vascular stent in a compressed state according to the first embodiment of the present invention;

FIG6 is a schematic diagram of the partial position of the vascular stent in the first embodiment of the present invention in a compressed state;

FIG7 is a schematic diagram of the structure of a vascular stent in Embodiment 2 of the present invention;

FIG8 is a schematic diagram of the structure of a vascular stent in Embodiment 3 of the present invention;

FIG. 9 is a schematic diagram of the structure of a blood vessel stent in another embodiment of the third embodiment of the present invention.

Detailed ways

In order to facilitate the understanding of the present invention, the present invention will be described more fully below with reference to the relevant drawings. The preferred embodiments of the present invention are given in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present invention more thoroughly understood.

It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation method.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which the present invention belongs. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and/or" includes any and all combinations of one or more of the associated listed items.

In the field of interventional medical devices, the end of an implant (such as a luminal stent) that is closer to the heart after release is usually defined as the proximal end, and the end that is farther from the heart is defined as the distal end. "Axial" generally refers to the length direction of the implant when it is delivered, and "radial" generally refers to the direction of the implant that is perpendicular to its "axial direction". The "axial" and "radial" of any part of the implant are defined based on this principle.

First embodiment

As shown in FIGS. 1-6, FIG. 1 is a schematic diagram of the structure of the vascular stent 100 in the first embodiment of the present invention; FIG. 2 is a schematic diagram of the structure of the first wave ring 1111 of the vascular stent 100 in the first embodiment of the present invention; FIG. 3 is a schematic diagram of the positions of the first wave ring 1111 and the second wave ring 1112 of the vascular stent 100 in the first embodiment of the present invention; FIG. 4 is a schematic diagram of the surrounding area of the first wave ring 1111 and the second wave ring 1112 of the vascular stent 100 in the first embodiment of the present invention; FIG. 5 is a schematic diagram of the overall state of the vascular stent 100 in the first embodiment of the present invention in a compressed state; FIG. 6 is a schematic diagram of the local position of the vascular stent 100 in the first embodiment of the present invention in a compressed state;

In this embodiment, the vascular stent 100 includes a stent body 11 and a coating 12 covering the surface of the stent body 11. The stent body 11 includes a plurality of wavy rings arranged axially along the center line of the stent, and is generally made of materials with good biocompatibility, such as nickel-titanium, stainless steel, cobalt-chromium alloy and the like. The coating 12 is made of a polymer material with good biocompatibility, such as ePTFE, PET, polyester cloth and the like.

The main body 11 includes a plurality of wave coils 111 . The waveform of the wave coils 111 can be in various shapes such as a Z-shaped wave, a U-shaped wave or a sine wave, and can also be freely changed.

In this embodiment, the wave circle 111 includes a plurality of first wave circles 1111, a second wave circle 1112 arranged in sequence, and a proximal wave circle 1113 and a distal wave circle 1114 located at the proximal end and the distal end, respectively, wherein the first wave circle 1111 and the second wave circle 1112 are adjacent wave circles among the plurality of wave circles 111.

In this embodiment, the peaks of the waveforms of the proximal wave circle 1113 are located at the same height, that is, the proximal wave circle The proximal side of 1113 is flush, and the troughs of each waveform of the distal wave coil 1114 are flush, that is, the distal side of the distal wave coil 1114 is flush, so that the wave coils located at the end in this embodiment are always flush after compression and release, thereby maintaining the stability of the two ends of the main body 11, and at the same time ensuring that the proximal wave coil 1113 and the distal wave coil 1114 provide relatively uniform support for the coating 12 on the proximal side and the distal wave coil 1114 provides relatively uniform support for the coating 12 on the distal side.

In this embodiment, the first wave circle 1111 includes a first wave 1113 and a second wave 1114 that are continuously distributed, wherein the first wave 1113 is a high wave, the second wave 1114 is a low wave, the first wave 1113 includes a first wave bar 11131 and a second wave bar 11132, and the second wave 1114 includes a third wave bar 11141 and a fourth wave bar 11142, which satisfies:

For the entire first wave circle 1111, the first wave rod 11131 is adjacent to the second wave rod 11132 and the fourth wave rod 11142, the second wave rod 11132 is adjacent to the first wave rod 11131 and the third wave rod 11141, and the third wave rod 11141 is adjacent to the second wave rod 11132 and the fourth wave rod 11142, and there is a smooth transition between the wave rods.

Therefore, in this embodiment, for the first wave circle 1111, it includes at least two wave peaks: a high wave peak 1121 (a wave peak between the first wave rod 11131 and the second wave rod 11132) and a low wave peak 1122 (a wave peak between the third wave rod 11141 and the fourth wave rod 11142); it also includes two wave troughs: a high wave trough 1123 (a wave trough between the first wave rod 11131 and the adjacent fourth wave rod 11142) and a low wave trough 1124 (a wave trough between the second wave rod 11132 and the third wave rod 11141).

In this embodiment, the second wave coil 1112 uses the same waveform structure as the first wave coil 1111, but the second wave coil 1112 has a phase difference with the first wave coil 1111, so that the low trough 1124 of the first wave coil 1111 corresponds to the low peak 1122 of the second wave coil 1112, and the high trough 1123 corresponds to the high peak 1113 of the second wave coil 1112. Therefore, under such a design, when the stent body 11 of this embodiment is compressed, the adjacent first wave coil 1111 and the second wave coil 1112 will not be axially superimposed, that is, they will not overlap each other by axially squeezing the coating 12, but the peaks and troughs will be mutually supported and limited to avoid excessive shortening of the stent, thereby reducing the risk of stent jump before release. When the stent is deployed, the waves are staggered to avoid local collapse due to excessive pores in the coating 12, and will not interfere with each other to affect the flexibility of the stent.

In this embodiment, the insertion height h between the first wave coil 1111 and the second wave coil 1112 and the height H of the first wave 1113 satisfy h＜H, thereby preventing the stent from twisting and damaging the blood vessel wall when released.

In addition, in order to ensure that the amount of compression of the coating 12 is uniform between the first wave coil and the second wave coil when the vascular stent 100 of this embodiment is compressed, that is, the axial cross-sectional area thereof in the conveyor will not be abnormally increased due to compression, for this embodiment, the area S1 of the coating 12 between the first wave coil 1111 and the second wave coil 1112 is equal to the area S2 of the coating 12 between the adjacent first wave coil 1111 and the second wave coil 1112, thereby ensuring that the deformation conditions of the coating 12 on the upper and lower sides are almost the same when the multiple first wave coils 1111 and the second wave coil 1112 are compressed.

In this embodiment, the multiple low troughs 1124 of the first wave circle 1111 and the multiple high peaks 1121 of the adjacent second wave circle 1112 are located at the same height (i.e., the same position in the axial direction). This can avoid the situation where the coating 12 between the first wave circle 1111 and the second wave circle 1112 has no wave circle support in the axial direction, thereby avoiding axial shortening of the stent.

In another embodiment, referring to FIG. 3 , for the high peak 1131 of the second wave coil 1112, its axial position is between the axial positions of the high trough 1133 and the low trough 1134 of the first wave coil 1111, so that when the stent is twisted, the high peak 1131 will be restricted by the high trough 1133 and the low trough 1134, thereby avoiding excessive twisting of the stent.

It should be noted that, in another embodiment, the vascular stent 100 is a bare stent.

Embodiment 2

The difference between this embodiment and the first embodiment is that the first and second wave circles of this embodiment are distributed obliquely. Referring to Figure 7, Figure 7 is a schematic diagram of the structure of the vascular stent in the second embodiment of the present invention, wherein the first wave circle 2111 and the second wave circle 2112 of this embodiment are distributed obliquely.

In order to make the amount of compression of the coating 22 of the embodiment uniform between the first wave circle and the second wave circle when the stent 200 is compressed, that is, the axial cross-sectional area of the coating 22 in the conveyor will not increase abnormally due to compression, For this embodiment, the area of the film 22 between the first wave circle 2111 and the second wave circle 2112 is equal to the area of the film 22 between the adjacent first wave circle 2111 and the second wave circle 2112, thereby ensuring that when the multiple first wave circles 2111 and the second wave circle 2112 are compressed, the deformation conditions of the upper and lower side films 22 are almost the same. However, what is different from the first embodiment is that in this embodiment, the area S1 of the film 22 between the first wave circle 2111 and the second wave circle 2112 and the area S2 of the film 22 between the adjacent first wave circle 2111 and the second wave circle 2112 both refer to the first wave circle 2111 that makes a complete circle and the second wave circle 2112 that makes a complete circle.

In another embodiment, the first wave and the second wave are continuous, that is, the first wave and the second wave themselves are continuous waves of the same thread distribution.

Embodiment 3

The difference between this embodiment and the first embodiment is that the first wave circle and the second wave circle of this embodiment are connected to each other. Referring to FIG8 , FIG8 is a schematic diagram of the structure of the vascular stent in the third embodiment of the present invention, wherein the first wave circle 3111 and the second wave circle 3112 of this embodiment include a plurality of connection points 3113, specifically, the connection points 3113 are located between the high trough 3123 of the first wave circle 3111 and the high crest 3121 of the second wave circle 3112, and the two adjacent connection points 3113 include two low crests 3122 of the second wave circle 3112.

In another embodiment, a plurality of low wave peaks 3122 are included between two adjacent connection points 3113 .

In order to ensure that the amount of compression of the coating 32 is uniform between the first wave coil and the second wave coil when the vascular stent 300 of this embodiment is compressed, that is, the axial cross-sectional area in the conveyor will not increase abnormally due to compression, for this embodiment, the area of the coating 32 between the first wave coil 3111 and the second wave coil 3112 is equal to the area of the coating 32 between the adjacent first wave coil 3111 and the second wave coil 3112, thereby ensuring that when multiple first wave coils 3111 and second wave coils 3112 are compressed, the deformation conditions of the coating 32 on the upper and lower sides are almost the same. However, different from the first embodiment, this embodiment also ensures that the deformation conditions of the coating 32 on both sides of the connection point 3113 are almost the same, that is, the area of the region enclosed by the two adjacent connection points 3113 and the first wave coil 3111 and the second wave coil 3112 is S and is equal.

In this embodiment, the overall size of the mesh area can be adjusted by adjusting the number of connection points 3113. Generally speaking, the more connection points 3113 there are, the more areas enclosed by two adjacent connection points 3113 and the first wave circle 3111 and the second wave circle 3112, which means the structure is closer to a closed-loop structure and the flexibility is lower. Conversely, the fewer connection points 3113 there are, the fewer areas enclosed by two adjacent connection points 3113 and the first wave circle 3111 and the second wave circle 3112, which means the structure is closer to an open-loop structure and the flexibility is higher.

In another embodiment, the number of connection points at the two end positions of the vascular stent is set to be small, that is, the end positions are close to or form an open-loop structure, so as to have a larger coating area, which can not only prevent the stenotic plaque from falling off, but also avoid the problem of poor flexibility of the end of the vascular stent and inability to conform to the blood vessel.

In another embodiment, referring to FIG. 9 , FIG. 9 is a schematic diagram of the structure of a blood vessel stent in another embodiment of the third embodiment of the present invention, in which the first wave ring 3111 and the second wave ring 3112 are both inclinedly distributed.

The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

A vascular stent comprises a stent body, characterized in that the stent body comprises a plurality of main wave coils, the main wave coils comprise at least two wave crests and/or wave troughs of different heights, the main wave coils comprise a first wave coil and a second wave coil, the first wave coil and the second wave coil have a phase difference, so that the multiple troughs of the first wave coil are distributed relative to the multiple wave crests of the second wave coil, and/or the multiple wave crests of the first wave coil are distributed relative to the multiple troughs of the second wave coil.
The vascular stent according to claim 1 is characterized in that the first wave ring includes a plurality of first waves and second waves that are continuously and alternately distributed, the first wave and the second wave have different wave heights, the first wave includes a first wave bar and a second wave bar, the second wave includes a third wave bar and a fourth wave bar, a high wave peak is formed between the first wave bar and the second wave bar, a low wave peak is formed between the third wave bar and the fourth wave bar, a high wave trough is formed between the first wave bar and the adjacent fourth wave bar, and a low wave trough is formed between the second wave bar and the third wave bar.
The vascular stent according to claim 2 is characterized in that the second wave coil has the same structure as the first wave coil, the low wave trough of the first wave coil corresponds to the low wave peak of the second wave coil, and the high wave trough of the first wave coil corresponds to the high wave peak of the second wave coil.
The vascular stent according to claim 3 is characterized in that the multiple low wave troughs of the first wave circle and the multiple high wave peaks of the adjacent second wave circle are located at the same position in the axial direction.
The vascular stent according to claim 3 is characterized in that the axial position of the high wave crest of the second wave ring is between the axial positions of the high wave trough and the low wave trough of the first wave ring.
The vascular stent according to claim 3, characterized in that the first wave coil and the second wave coil are distributed obliquely.
The vascular stent according to claim 3 is characterized in that it also includes two end wave circles, wherein the end wave circles include a proximal wave circle and a distal wave circle, and the proximal side wave peaks of the proximal wave circle are flush. The wave troughs on the distal side of the distal wave ring are flush.
The vascular stent according to any one of claims 1-7 is characterized in that a plurality of regions are included between the first wave ring and the second wave ring, and the areas of the plurality of regions are equal.
The vascular stent according to claim 8 is characterized in that a plurality of connection points are provided between the first wave circle and the second wave circle, the connection points are located between the high wave trough of the first wave circle and the high wave peak of the second wave circle, and at least two of the low wave peaks of the second wave circles are included between adjacent connection points.
The vascular stent according to any one of claims 1-7 is characterized in that the first wave coil and the second wave coil are different wave bands on one wave coil, and the wave coil is distributed in a threaded manner as a whole.