CN113367864B

CN113367864B - Medical braided support

Info

Publication number: CN113367864B
Application number: CN202010157938.XA
Authority: CN
Inventors: 苗琳莉; 张滢涛; 刘辰洋
Original assignee: Shentu Medical Technology Shanghai Co ltd
Current assignee: Shentu Medical Technology Shanghai Co ltd
Priority date: 2020-03-09
Filing date: 2020-03-09
Publication date: 2024-03-08
Anticipated expiration: 2040-03-09
Also published as: CN113367864A

Abstract

The invention relates to a medical braided stent and a treatment device, wherein the treatment device comprises the medical braided stent, the medical braided stent comprises at least one first stent body and at least one second stent body, the first stent body comprises a multi-layer network management structure, the second stent body comprises a single-layer network management structure, the first stent body and the second stent body are arranged at intervals and are axially connected, and the first stent body and the second stent body are integrally braided and formed. By arranging the first stent body into a multi-layer network management structure, when the medical braided stent is implanted into a carrying aneurysm and the first stent body is arranged at the neck of the aneurysm, the first stent body can effectively change the blood flow dynamics in the carrying aneurysm, reduce the blood flow exchange between the carrying aneurysm and the aneurysm and promote the formation of thrombus in the aneurysm.

Description

Medical braided support

Technical Field

The invention relates to the technical field of medical instruments, in particular to a medical braided stent.

Background

Intracranial aneurysms are mostly abnormal bulging occurring on the wall of an intracranial arterial blood vessel, and are the first cause of subarachnoid hemorrhage, and the current treatment methods of intracranial aneurysms mainly comprise intratumoral spring coil embolism treatment and blood Flow guiding device (FD) treatment.

The intratumoral spring coil embolism treatment is to fill a spring coil in an aneurysm sac so as to eliminate the blood flow in the aneurysm sac and further eliminate the risk of rupture and bleeding of the aneurysm; FD treatment is performed by implanting a blood flow guiding device within the parent artery to alter the hemodynamics to disrupt blood flow from the parent artery into the aneurysm, reducing blood exchange between the parent artery and the aneurysm, resulting in thrombus formation within the aneurysm, promoting complete occlusion of the aneurysm. Studies show that the FD method has obvious advantages in treating fusiform, large or huge intracranial aneurysms, and the complete embolism rate of the long-term follow-up aneurysms can be 76% -93%.

In the prior art, partial aneurysms remain incompletely occluded or chronically unhealed after FD treatment. In this regard, this can be addressed by releasing a single FD and pushing it densely, or by overlapping two FD releases to improve the metal coverage of the tumor neck. However, the two methods are difficult to operate, especially when two FDs are used in a telescopic manner, the problem of poor stent adhesion caused by improper operation is very easy to occur, and a third FD is required to be added for remedying at the moment, and the risk of ischemia complications is increased due to excessive FDs.

Disclosure of Invention

The invention aims to provide a medical braided stent, which can effectively improve the treatment effect of aneurysms and reduce the operation difficulty of stent implantation.

In order to achieve the above purpose, the medical braided stent provided by the invention comprises at least one first stent body and at least one second stent body, wherein the first stent body comprises a multi-layer network management structure, the second stent body comprises a single-layer network management structure, the first stent body and the second stent body are arranged at intervals and are axially connected, and the first stent body and the second stent body are integrally braided and formed.

Optionally, the coverage rate of the braided filaments of the first stent body is 5% -60%.

Optionally, the coverage rate of the braided filaments of the second stent body is 5% -60%.

Optionally, the number of the braiding wires in the medical braiding bracket is 24-96.

Optionally, the medical braided stent is braided from metal wires.

Optionally, the medical braided stent is formed by braiding a mixture of metal wires and non-metal wires.

Optionally, the number of the heads of the braiding wires of the mesh tubular structure of each layer of the first stent body is equal.

Optionally, the first support body is a two-layer network management structure.

Optionally, in the transition region of the first support body and the second support body, the braiding wires of the second support body are split from outside to inside or from inside to outside in sequence of the first support body, and braiding is performed by the braiding wires split to the same layer.

Optionally, in each layer of the first stent body, adjacent braided filaments intersect to form an interweaving point in the transition region.

Optionally, in the transition region of the first support body and the second support body, the braiding wires of all layers of the first support body are sequentially integrated according to the layer sequence from outside to inside or from inside to outside of the first support body, the braiding wires of the upper layer and the braiding wires of the lower layer are intersected to form an interweaving point, and the multi-layer wires are circularly interweaved to form the second support body.

Optionally, the device comprises a first bracket body and two second bracket bodies, wherein the two second bracket bodies are respectively arranged at the proximal end and the distal end of the first bracket body.

Optionally, the length of one first stent body accounts for 15% -90% of the total length of the medical braided stent.

Optionally, the length of one second stent body accounts for 5% -50% of the total length of the medical braided stent.

Optionally, the device further comprises a first developing element, and the first developing element is arranged on the second bracket body.

Optionally, the device comprises a first bracket body and two second bracket bodies, wherein the two second bracket bodies are respectively arranged at the proximal end side and the distal end side of the first bracket body; the number of the first developing elements is at least two, and the first developing elements are respectively arranged on the two second bracket bodies.

Optionally, the device further comprises a second developing element, and the second developing element is arranged on the first bracket body.

Optionally, the braiding wires used to braid the second stent body are at least partially developable; and/or the number of the groups of groups,

the braided filaments used to braid the first stent body are at least partially developable.

Compared with the prior art, the medical braided stent has the following advantages:

the medical device comprises a medical braided support, the medical braided support comprises a first support body and a second support body, the first support body comprises a multi-layer net tubular structure, the second support body comprises a single-layer net tubular structure, the first support body and the second support body are arranged at intervals and are axially connected, and the first support body and the second support body are integrally braided. When the medical braided stent is implanted into a parent artery, the first stent body is arranged at a tumor neck opening of the aneurysm, and the change of blood flow dynamics in the parent artery can be enhanced through a multi-layer network tubular structure, so that the blood flow exchange between the parent artery and the aneurysm is reduced, and the thrombus formation in the aneurysm is promoted. Moreover, the medical braided stent is integrally braided and formed, the network management structures of the first stent body and the second stent body are not required to be connected through an additional process, the production process of the medical braided stent is simplified, and adverse effects caused by connection failure of each network management structure are avoided. And through the medical braided stent of this application, can replace the condition that a plurality of supports intussusception used among the prior art, the propelling movement is simple, easily operation.

Drawings

FIG. 1 is a schematic structural view of a medical braided stent according to an embodiment of the present invention;

FIG. 2a is a cross-sectional view A-A of the medical braided stent shown in FIG. 1;

FIG. 2B is a B-B cross-sectional view of the medical braided stent shown in FIG. 1;

fig. 3 is a schematic view of the medical braided stent of fig. 1 as applied to the treatment of an aneurysm.

Reference numerals are described as follows:

10-a medical braided stent;

11-a first bracket body, 11 A-An inner layer network tubular structure, and 11 b-an outer layer network tubular structure;

12-a second bracket body;

20-aneurysms;

30-carrying tumor artery.

Detailed Description

The invention will be further described in detail with reference to the accompanying drawings, in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention.

As used in this specification, the singular forms "a", "an" and "the" include plural referents, unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, as for example, they may be fixed, they may be removable, or they may be integrally connected. Either mechanically or electrically. Can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances. The same or similar reference numbers in the drawings refer to the same or similar parts.

As used herein, the terms "proximal" and "distal" refer to the relative orientation, relative position, orientation of elements or actions relative to one another from the perspective of the physician using the medical device, although "proximal" and "distal" are not intended to be limiting, and "proximal" generally refers to the end of the medical device that is adjacent to the physician during normal operation, and "distal" generally refers to the end that first enters the patient.

The invention provides a medical braided stent, which comprises at least one first stent body and at least one second stent body, wherein the first stent body comprises a multi-layer network management structure, the second stent body comprises a single-layer network management structure, and the first stent body and the second stent body are arranged at intervals and are axially connected. The first bracket body and the second bracket body are integrally woven and formed.

The following description is made with reference to the accompanying drawings.

Referring to fig. 1, 2a and 2b, in one embodiment, the medical braided stent 10 includes at least one first stent body 11 and at least one second stent body 12, for example, two second stent bodies 12 are shown. Each of the first stent bodies 11 has opposite proximal and distal ends, and each of the proximal and distal ends of the first stent bodies 11 may be provided with one of the second stent bodies 12. Each first bracket body 11 includes at least two mesh tubular structures, the at least two mesh tubular structures are coaxially and stacked so that the first bracket body 11 is formed into a multi-layer structure, and the second bracket body 12 is a single-layer structure formed by one mesh tubular structure.

Alternatively, depending on the number of the first stent body 11 and the second stent body 12 in the medical braided stent 10, the length of each of the first stent bodies 11 occupies 15% -90% of the total length of the medical braided stent 10, and the length of each of the second stent bodies 12 occupies 5% -50% of the total length of the medical braided stent 10.

In the following description, it is assumed that the number of the first stent bodies 11 is one and the first stent bodies 11 are two-layered mesh tubular structures, and the number of the second stent bodies 12 is two to further explain the medical braided stent 10 of the present invention. Those skilled in the art should be able to modify the following description to apply it to the case where the medical braided stent 10 includes one of the first stent body 11 and one of the second stent bodies 12, or two or more of the first stent bodies 11 and three or more of the second stent bodies 12, and the first stent body 11 includes three or more layers of mesh tubular structures.

Hereinafter, for convenience of description, the two mesh tubular structures of the first stent body 11 will be referred to as an inner mesh tubular structure 11a and an outer mesh tubular structure 11b, respectively (as shown in fig. 2 a).

The medical braided stent 10 provided in this embodiment is suitable for treatment of aneurysms. Fig. 3 shows a schematic view of the implantation of the medical braided stent 10 into a diseased vessel for treatment of an aneurysm. As shown in fig. 3, an aneurysm 20 grows on the wall of an artery, referred to as the parent artery 30. The medical braided stent 10 is implanted in the parent artery 30, and the first stent body 11 is disposed at the aneurysm 20 and is in close contact with the neck opening of the aneurysm 20. Two of the second stent bodies 12 are disposed on both sides of the aneurysm 20, respectively. Because the first stent body 11 has a two-layer mesh-like structure, the two-layer mesh-like structure can enhance the interference on the hemodynamics of the parent artery 30, so as to further reduce the blood flow exchange between the parent artery 30 and the aneurysm 20, and promote the thrombus generation in the aneurysm 20. Meanwhile, the two mesh tubular structures of the first stent body 11 belong to the same medical braided stent 10, so that only one pushing process is required to be performed, and the medical braided stent 10 has the advantages of simple pushing and easy operation.

Further, the medical braided stent 10 is braided by using metal wires, or the medical braided stent 10 is braided by mixing metal wires and non-metal wires, or the medical braided stent 10 is braided by non-metal wires. The metal wire may include nickel-titanium alloy wire, cobalt-chromium alloy wire, platinum-iridium alloy wire, platinum-tungsten alloy wire, etc., the nonmetal wire includes degradable wire, such as protein wire or polymer wire, etc., and the raw material for preparing the polymer wire may include polylactic acid-glycolic acid copolymer (PLGA), polyethylene terephthalate (PET), etc.

Further, the coverage of the braided filaments of the first stent body 11 may be between 5% -60% to ensure effective interference of the first stent body 11 with hemodynamics. The coverage rate of the braided filaments of the first stent body 11 may be specifically 5%, 10%, 20%, 30%, 35%, 40%, 50%, 55%, 60%, or the like. The coverage of the respective braided filaments of the inner layer mesh tubular structure 11a and the outer layer mesh tubular structure 11b is not strictly limited in this embodiment as long as the total coverage of the braided filaments of both meets the requirements.

The coverage of the braided filaments of any one of the second stent bodies 12 may be less than, equal to, or greater than the coverage of the braided filaments of the first stent body 11. The coverage of the braiding wires of the two second stent bodies 12 may be equal or unequal, for example, the coverage of the braiding wires of the second stent body 12 connected to the proximal end of the first stent body 11 may be between 5% -60%, specifically may be 5%, 10%, 15%, 20%, 25%, 35%, 40%, 50%, 60%, etc., and the coverage of the braiding wires of the second stent body 12 connected to the distal end of the first stent body 11 may be between 5% -60%, specifically may be 5%, 10%, 18%, 25%, 30%, 35%, 40%, 50%, 60%, etc. The coverage of the braided filaments of the two second stent bodies 12 should be as small as possible, provided that the strength of the medical braided stent 10 is met, to reduce the likelihood of complications of the medical braided stent 10 after implantation in the parent artery 30. As will be appreciated by those skilled in the art, the "coverage of braided filaments" refers to the ratio of the area covered by braided filaments of the medical braided stent 10 of any portion to the area of the medical braided stent 10 of the corresponding portion.

In one exemplary embodiment, the medical braided stent 10 is continuously braided from braided filaments. Specifically, a single-layer mesh tubular structure is formed by first interweaving a plurality of braided filaments as a first one of the second stent bodies 12. Next, the plurality of braided wires are divided into a first group of braided wires and a second group of braided wires, and then the first group of braided wires are interwoven with each other to form an inner mesh tubular structure 11a of the first stent body 11, and then the second group of braided wires are interwoven with each other to form an outer mesh tubular structure 11b of the first stent body 11, the outer mesh tubular structure 11b being wrapped around the outside of the inner mesh tubular structure 11a (as shown in fig. 2 a). Finally, each of the first set of braided filaments and the second set of braided filaments are interwoven to form a single-layer mesh tubular structure as the other second stent body 12. In this way, no additional connection is needed between the two mesh tubular structures of the first bracket body 11 and the mesh tubular structure of the second bracket body 12, so that the process is simple, and the risk of connection failure between the mesh tubular structures is avoided.

Specifically, in the transition region between the first support body 11 and the second support body 12, the braiding wires of the second support body 12 are sequentially split according to the layer sequence of the first support body 11 from outside to inside or from inside to outside, and the braiding wires split to the same layer are braided. If 24 single-layer braided wires of the second support body 12 are used, the first support body 11 has two layers, the single-layer braided wires of the second support body 12 are split in sequence according to the sequence of inner layer-outer layer-inner layer-outer layer, the braided wires split to the inner layer are sequentially interwoven for braiding, and the braided wires split to the outer layer are sequentially interwoven for braiding. Preferably, the number of the braiding thread heads of the second stent body 12 is an integer multiple of the number of layers of the first stent body 11, for example, the number of the braiding thread 24 heads is 12 times of the number of layers of the first stent body 11. The number of knitting yarn heads of each layer of the first bracket body 11 is equal.

In the transition region between the first support body 11 and the second support body 12, the braiding wires of all the layers of the first support body 11 are sequentially integrated according to the layer sequence from outside to inside or from inside to outside of the first support body 11, the braiding wires of the upper layer and the braiding wires of the next layer intersect to form an interweaving point, and the multi-layer wires are interweaved in a circulating manner to form the second support body 12. For example, 24 single-layer braided wires of the second support body 12 are used, the first support body 11 has a two-layer structure, so that one inner-layer braided wire of the first support body 11 and an adjacent outer-layer braided wire intersect to form an interweaving point, and the second inner-layer braided wire and an adjacent other outer-layer braided wire intersect to form an interweaving point, so as to form the second support body 12. 24 single-layer braided wires of the second bracket body 12 are used, the first bracket body 11 has a three-layer structure, so that one inner-layer braided wire of the first bracket body 11 is intersected with an adjacent middle-layer braided wire to form an interweaving point, one middle-layer braided wire is intersected with an adjacent outer-layer braided wire to form an interweaving point, and one outer-layer braided wire is intersected with an adjacent other inner-layer braided wire to form an interweaving point, so that the second bracket body 12 is formed. Preferably, the number of the braiding wires of the second stent body 12 is an integer multiple of the number of layers of the first stent body 11, for example, the number of the braiding wires 24 is 12 times of the number of layers of the first stent body. The number of knitting yarn heads of each layer of the first bracket body 11 is equal.

The medical braided stent 10 is formed by integrally braiding braided filaments, and when the second stent body 12 is braided, the coverage rate of the braided filaments of the second stent body 12 is controlled to be smaller than that of the braided filaments of the first stent body 11 by controlling the overlapping amount (PPI) between the braided filaments in the radial direction.

In order to make the coverage rate of the braided wires of the first stent body 11 and the second stent body 12 reach a predetermined value, the number of braided wires used for braiding the medical braided stent 10 is 24 to 96. When the medical braided stent 10 is braided by a mixture of metal wires and nonmetal wires, the strength of the medical braided stent 10 is determined according to actual conditions, and the ratio of the metal wires to the nonmetal wires is designed. The ratio of the wires to the non-wires is designed to be well known to those skilled in the art and will not be described in detail herein.

In this embodiment, the medical braided stent 10 further includes a first developing element (not shown in the drawings), for example, the number of the first developing elements may be two, and the two first developing elements are respectively disposed on the two second stent bodies 12, so as to facilitate the determination of the position of the medical braided stent 10 when the medical braided stent 10 is implanted in the parent artery 30.

The medical braided stent 10 further includes a second developing element (not shown) disposed on the first stent body 11, and the second developing element is used to determine whether the first stent body 11 is facing the neck opening of the aneurysm 20 during implantation of the medical braided stent 10. Preferably, the number of the second developing elements may be two, and the two second developing elements may be disposed at the proximal end and the distal end of the first frame body 11, respectively.

In other embodiments, for example, the two mesh tubular structures of the first stent body 11 and the mesh tubular structure of the second stent body 12 are respectively woven and formed, and then connected together, the medical woven stent 10 may also be woven by selecting a woven wire with developing property. Specifically, when at least part of the braided wires used for braiding the second stent body 12 have developability, the second stent body 12 correspondingly has developability. When at least part of the braided wires used for braiding the first stent body 11 have developability, the first stent body 11 correspondingly has developability. In addition, in the case of implanting the medical braided stent 10 in the parent artery, in order to distinguish the first stent body 11 from the second stent body 12, the developability of the braided wire for braiding the first stent body 11 may be different from that for braiding the second stent body 12.

Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, it is intended that the present invention also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

1. The medical braided stent is characterized by comprising at least one first stent body and at least one second stent body, wherein the first stent body comprises a multi-layer network management structure, the second stent body comprises a single-layer network management structure, the first stent body and the second stent body are arranged at intervals and are axially connected, and the first stent body and the second stent body are integrally braided;

in the transition region of the first support body and the second support body, the braiding wires of the second support body are split in sequence according to the layer sequence from outside to inside or from inside to outside of the first support body, braiding is carried out by the braiding wires split to the same layer, and adjacent braiding wires of the same layer are intersected to form an interweaving point; or,

in the transition region of the first support body and the second support body, the braiding wires of all layers of the first support body are sequentially integrated according to the sequence of layers of the first support body from outside to inside or from inside to outside, the braiding wires of the upper layer and the braiding wires of the lower layer are intersected to form an interweaving point, and the multi-layer wires are circularly interweaved to form the second support body.

2. The medical braided stent of claim 1, wherein the coverage of braided filaments of the first stent body is 5% -60%.

3. The medical braided stent of claim 2, wherein the coverage of braided filaments of the second stent body is 5% -60%.

4. The medical braided stent of claim 1, wherein the number of braided filaments in the medical braided stent is 24-96.

5. The medical braided stent of claim 1, wherein the medical braided stent is braided from wire.

6. The medical braided stent of claim 1, wherein the medical braided stent is braided from a mixture of wires and non-wires.

7. The medical braided stent of claim 1, wherein the number of braided filaments of the mesh-like structure of each layer of the first stent body is equal.

8. The medical braided stent of claim 1, wherein the first stent body is a two-layered mesh tubular structure.

9. The medical braided stent of claim 1, comprising one of the first stent body and two of the second stent bodies, and the two of the second stent bodies are disposed at a proximal end and a distal end of the first stent body, respectively.

10. The medical braided stent of claim 1, wherein the length of one of said first stent bodies is 15% -90% of the total length of said medical braided stent.

11. The medical braided stent of claim 10, wherein the length of one of said second stent bodies is between 5% and 50% of the total length of said medical braided stent.

12. The medical braided stent of claim 1, further comprising a first developing element disposed on the second stent body.

13. The medical braided stent of claim 12, comprising one of the first stent body and two of the second stent bodies, the two second stent bodies being disposed on a proximal side and a distal side of the first stent body, respectively; the number of the first developing elements is at least two, and the first developing elements are respectively arranged on the two second bracket bodies.

14. The medical braided stent of claim 12, further comprising a second developing element disposed on the first stent body.

15. The medical braided stent of claim 1, wherein braided filaments used to braid the second stent body are at least partially developable; and/or the number of the groups of groups,