Medical stent system

By installing procoagulant made of procoagulant fibers on the outer peripheral surface of the coated stent of the medical stent system, filling the tumor cavity, slowing down blood flow rate and promoting blood clots, the problem of type II internal leakage after EVAR surgery is solved and the patient's survival rate is improved.

WO2025066340A1PCT designated stage expired Publication Date: 2025-04-03SHANGHAI MICROPORT ENDOVASCULAR MEDTECH (GRP) CO LTD
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Patent Information

Application Number
PCT/CN2024/101516
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-25
Filing Date
2024-06-26
Publication Date
2025-04-03

AI Technical Summary

Technical Problem

The high incidence of type II endospermia after EVAR surgery leads to persistent enlargement and rupture of the tumor cavity, affecting the patient's survival rate.

Method used

A medical stent system is designed, including a coated stent and a coagulant arranged on the outer peripheral surface of the coated stent. The coagulant is composed of a plurality of coagulant fibers to fill the tumor cavity, slow down blood flow rate, and promote blood clots.

Benefits of technology

By slowing blood flow rate and promoting blood clots, reducing the occurrence of type II endothelial, avoiding the persistent enlargement and rupture of the tumor cavity, and improving patient survival.

✦ Generated by Eureka AI based on patent content.

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Abstract

Provided in the present invention is a medical stent system comprising a coated stent and a coagulation promoting member arranged on the peripheral surface of the coated stent, wherein the coagulation promoting member comprises a plurality of coagulation promoting fibers and is used for filling a tumor cavity to slow down the flow rate of blood entering the tumor cavity and promote blood clotting in the tumor cavity. Therefore, the incidence of type II endoleaks can be reduced or even avoided, thereby avoiding continuous expansion of the tumor cavity.
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Description

A medical stent system Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a medical stent system. Background Art

[0002] In recent years, endovascular abdominal aortic aneurysm repair (EVAR) has become the preferred treatment option for interventional physicians. As a minimally invasive surgical procedure, EVAR provides a smaller incision, making it accessible to high-risk patients who cannot tolerate open-chest surgery.

[0003] However, long-term clinical data studies have shown that the efficacy of EVAR surgery has not met expectations. Studies have shown that within six months after surgery, EVAR patients have a higher survival rate than those undergoing open-chest surgery, but this survival advantage gradually disappears over time. Furthermore, eight years after surgery, the overall survival rate of EVAR patients is lower than that of patients undergoing open-chest surgery. This result may be due to the subsequent rupture of the aortic aneurysm caused by EVAR surgery. Endoleaks are prone to occur after EVAR surgery. According to statistics, the overall incidence of various types of endoleaks after EVAR surgery is 20% to 50%, with the incidence of type II endoleaks as high as 10% to 25%. The occurrence of type II endoleaks will lead to the continuous expansion of the aneurysm cavity, which may lead to rupture.

[0004] Summary of the Invention

[0005] The object of the present invention is to provide a medical stent system, which is intended to fill the tumor cavity to slow down the flow rate of blood entering the tumor cavity, promote blood clotting in the tumor cavity, and avoid type II endoleak.

[0006] To achieve the above-mentioned objectives, the present invention provides a medical stent system, comprising a coated stent and a coagulant-promoting member arranged on the outer peripheral surface of the coated stent, wherein the coagulant-promoting member includes a plurality of coagulant-promoting fibers for filling the tumor cavity to slow down the flow rate of blood entering the tumor cavity and promote blood clotting in the tumor cavity.

[0007] Optionally, the coagulation promoter further includes a self-expanding shaping portion, the coagulation promoter fiber is attached to the shaping portion, one end of the shaping portion is connected to the coated stent, and the other end is a free end; the shaping portion is at least partially pre-shaped into a three-dimensional structure.

[0008] Optionally, all the coagulation promoters are divided into several coagulation promoter assemblies, each of which includes multiple coagulation promoters; all the coagulation promoter assemblies are arranged at intervals along the circumference of the coated stent; all the coagulation promoters of the same coagulation promoter assembly are arranged at intervals along the axial direction of the coated stent and are spirally arranged around the axis of the coated stent.

[0009] Optionally, the coated stent includes a first sub-stent and two second sub-stents, the two second sub-stents are connected in parallel to the same axial end of the first sub-stent and are respectively connected to the first sub-stent; some segments of the second sub-stent are embolization segments; the coagulation promoter is provided on the outer peripheral surface of the first sub-stent and the outer peripheral surface of each of the embolization segments.

[0010] Optionally, all the coagulants arranged on the first sub-branch are divided into several first coagulant assemblies, each of which includes a plurality of coagulants; all the first coagulant assemblies are arranged at intervals along the circumference of the first sub-branch; all the coagulants of the same first coagulant assembly are arranged at intervals along the axial direction of the first sub-branch and spirally arranged around the axis of the first sub-branch; and / or, all the coagulants on each embolization segment are divided into several second coagulant assemblies, each of which includes a plurality of coagulants; all the second coagulant assemblies located on the same embolization segment are arranged at intervals along the circumference of the corresponding second sub-branch; all the coagulants of the same second coagulant assembly are arranged at intervals along the axial direction of the corresponding second sub-branch and spirally arranged around the axis of the corresponding second sub-branch.

[0011] Optionally, the first sub-stent comprises a plurality of stent rings spaced apart along its axial direction, and there are 1 to 3 stent rings spaced apart between two adjacent coagulation promoting members of the same first coagulation promoting assembly; and / or,

[0012] Each of the second sub-supports includes a plurality of support rings spaced apart along its axial direction, and there are 1 to 3 support rings spaced apart between two adjacent coagulation promoting members of the same second coagulation promoting assembly.

[0013] Optionally, the coagulation promoter provided on the outer peripheral surface of the first sub-support is inclined relative to the axis of the first sub-support; and / or the coagulation promoter provided on the outer peripheral surface of the embolization segment is inclined relative to the axis of the corresponding second sub-support.

[0014] Optionally, the first sub-stent comprises a first segment and a second segment connected axially, and one end of the second segment away from the first segment is connected to two second sub-stents;

[0015] The length of the coagulation-promoting fiber of the coagulation-promoting member provided on the first segment is 5 mm to 50 mm, and the length of the coagulation-promoting fiber of the coagulation-promoting member provided on the second segment is 50 mm to 110 mm;

[0016] The length of the coagulation-promoting fibers of the coagulation-promoting member provided on the second sub-support is 5 mm to 50 mm; and / or,

[0017] The number of the coagulation-promoting fibers of each coagulation-promoting member arranged on the first segment is less than the number of the coagulation-promoting fibers of each coagulation-promoting member arranged on the second segment; the number of the coagulation-promoting fibers of each coagulation-promoting member arranged on the second segment is greater than the number of the coagulation-promoting fibers of each coagulation-promoting member arranged on the second sub-bracket.

[0018] Optionally, the coated stent includes a first sub-stent and two second sub-stents, the two second sub-stents are connected in parallel to the same axial end of the first sub-stent and are respectively communicated with the first sub-stent; the first sub-stent includes an axially connected first segment and a second segment, the second segment is communicated with the two second sub-stents at one end away from the first segment; some segments of the second sub-stent are embolization segments; the coagulation promoter is provided on the outer circumferential surface of the first sub-stent and the outer circumferential surface of each of the embolization segments;

[0019] The axial length of the shaping portion of the coagulation promoter arranged on the first segment is 5mm to 20mm, and the axial length of the shaping portion of the coagulation promoter arranged on the second segment is 15mm to 50mm; and / or, the axial length of the shaping portion arranged on the embolization segment is 5mm to 20mm.

[0020] Optionally, a coagulation-promoting coating is provided on at least a portion of the outer surface of the coagulation-promoting member.

[0021] Compared with the prior art, the medical stent system of the present invention has the following advantages:

[0022] The aforementioned medical stent system includes a covered stent and a coagulant-promoting element disposed on the outer circumference of the covered stent. The coagulant-promoting element comprises a plurality of coagulant-promoting fibers that are used to fill the aneurysm cavity, slowing the flow of blood entering the aneurysm cavity and promoting blood clotting within the aneurysm cavity. This can reduce the occurrence of type II endoleaks and prevent the continued expansion of the aneurysm cavity.

[0023] Furthermore, the coagulation promoting member also includes a self-expanding shaping portion, the coagulation promoting fibers are attached to the shaping portion, the shaping portion is connected to the stent graft, and the shaping portion is at least partially pre-shaped into a three-dimensional structure. When the medical stent system is implanted in a blood vessel and is at least partially located in the aneurysm cavity of an aortic aneurysm, the shaping portion naturally expands to a predetermined shape, and the coagulation promoting fibers thereon stretch accordingly. Under the support of the shaping portion, the coagulation promoting fibers will not be impacted by the blood flow and collapse to the outer peripheral surface attached to the stent graft, so that the coagulation promoting fibers can effectively fill the aneurysm cavity, thereby effectively slowing down the flow rate of blood entering the aneurysm cavity, promoting blood clotting, and then blocking the blood flow in the aneurysm cavity, reducing the pressure in the aneurysm cavity, and thus avoiding the occurrence of type II endoleak.

[0024] Furthermore, all the coagulation promoters are divided into a number of coagulation promoter assemblies, and the coagulation promoter assemblies include a plurality of the coagulation promoters; all the coagulation promoter assemblies are arranged at intervals along the circumference of the coated stent; all the coagulation promoters of the same coagulation promoter assembly are arranged at intervals along the axial direction of the coated stent and spirally arranged around the axis of the coated stent; or, the coated stent includes a first sub-stent and a second sub-stent, and some segments of the second sub-stent are embolic segments; the coagulation promoters are provided on the embolic segments of the first sub-stent and the second sub-stent; all the coagulation promoters provided on the first sub-stent are divided into a number of first coagulation promoter assemblies, and all the first coagulation promoter assemblies are arranged in the The first sub-stent is arranged at intervals along the circumference, and each first coagulation promoting component includes a plurality of coagulation promoting elements. All the coagulation promoting elements of the same first coagulation promoting component are arranged at intervals along the axial direction of the first sub-stent and arranged spirally around the axis of the first sub-stent; the coagulation promoting elements provided on the embolization segment are divided into a plurality of second coagulation promoting elements. All the second coagulation promoting elements on the same embolization segment are arranged at intervals along the circumference of the corresponding second sub-stent. Each second coagulation promoting component includes a plurality of coagulation promoting elements. All the coagulation promoting elements of the same second coagulation promoting component are arranged at intervals along the axial direction of the corresponding second sub-stent and arranged spirally around the axis of the corresponding second sub-stent. The arrangement of the coagulation promoting elements can effectively reduce the overlap between the different coagulation promoting elements, avoid tangling of the coagulation promoting elements, enable them to fill the tumor cavity to slow down the flow rate of blood entering the tumor cavity, promote blood clotting in the tumor cavity, and avoid type II endoleak; at the same time, it can effectively reduce the resistance encountered by the medical stent system when it is pressed into the delivery system during production and when it is released in the blood vessel cavity, thereby increasing production stability and safety during surgical treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The accompanying drawings are provided for a better understanding of the present invention and are not intended to limit the present invention.

[0026] FIG1 is a schematic structural diagram of a medical stent system according to an embodiment of the present invention, showing a first sub-stent and two second sub-stents, but the second sub-stents shown in the figure are incomplete;

[0027] FIG2 shows a schematic diagram of an abdominal aortic aneurysm;

[0028] FIG3 is a schematic diagram showing a medical stent system provided by an embodiment of the present invention when applied to the treatment of abdominal aortic aneurysm;

[0029] FIG4 is a schematic structural diagram of a medical stent system according to an embodiment of the present invention. FIG4 differs from FIG1 in that the structure of the coagulation promoting member is different;

[0030] FIG5 is a schematic structural diagram of a coagulation-promoting component of the medical stent system provided in FIG4 ;

[0031] FIG6 is a schematic structural diagram of a shaping portion of a coagulation-promoting member of the medical stent system provided in FIG4 ;

[0032] FIG. 7 is a schematic diagram of the medical stent system provided in FIG. 4 when applied to the treatment of abdominal aortic aneurysm.

[0033] [Description of reference numerals is as follows]:

[0034] 110-first sub-stent, 111-first segment, 112-second segment, 120-second sub-stent, 121-embolization segment, 200-coagulant, 210-coagulant fiber, 220-shaping part, 221-three-dimensional spiral structure, 300-anchoring mechanism, 101-stent ring, 102-membrane, 10-aortic aneurysm, 21-blood inflow tract, 22-blood outflow tract, 23-abdominal aorta, 24-left iliac artery, 25-right iliac artery. DETAILED DESCRIPTION

[0035] The following describes the embodiments of the present invention through specific specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in this embodiment only illustrate the basic concept of the present invention in a schematic manner, and the drawings only show components related to the present invention rather than being drawn according to the number, shape and size of components during actual implementation. During actual implementation, the type, quantity and proportion of each component can be changed at will, and the component layout type may also be more complicated.

[0036] In addition, each embodiment described below has one or more technical features. However, this does not mean that users of the present invention must implement all technical features in any embodiment at the same time, or that they can only implement some or all technical features in different embodiments separately. In other words, as long as implementation is possible, those skilled in the art can, based on the disclosure of the present invention and depending on design specifications or implementation requirements, selectively implement some or all technical features in any embodiment, or selectively implement a combination of some or all technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0037] As used in this specification, the singular forms "a", "an", and "the" include plural objects, and the plural form "a plurality" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense that includes "and / or", unless the content clearly indicates otherwise, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be internal communication between two elements or an interactive relationship between two elements. Relational terms such as "first", "second", etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor do they indicate or imply relative importance or implicitly indicate the number of technical features indicated. It should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "up," "down," "front," "back," "left," "right," "vertical," "horizontal," "top," "bottom," "inside," "outside," "axial," "radial," "circumferential," and the like, indicating positions or location relationships, are based on the positions or location relationships shown in the accompanying drawings and are intended only to facilitate description and simplify the description of the present invention. They do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be construed as limiting the present invention. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0038] The purpose of the present invention is to provide a medical stent system that can be used for interventional treatment of aortic aneurysms. It avoids the occurrence of type II endoleak by promoting embolization of the aneurysm cavity, thereby avoiding the problem of continuous expansion or even rupture of the aneurysm cavity caused by type II endoleak.

[0039] To make the objects, advantages, and features of the present invention more apparent, the present invention is further described below in conjunction with specific embodiments and accompanying drawings. It should be noted that the drawings are greatly simplified and not to exact scale, and are intended solely to facilitate and clearly illustrate the purposes of the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar components.

[0040] Referring to Figures 1 and 4 to 6 , a medical stent system provided in an embodiment of the present invention includes a stent graft and a coagulant-promoting member 200 disposed on the outer circumference of the stent graft, wherein the coagulant-promoting member 200 includes a plurality of coagulant-promoting fibers 210. The medical stent system is used to treat an aortic aneurysm 10 as shown in Figure 2 , wherein the aneurysm cavity of the aortic aneurysm 10 is connected to a plurality of collateral vessels, wherein a portion of the collateral vessels form a blood inflow channel 21, and another portion of the collateral vessels form a blood outflow channel 22. When the medical stent system is used, as shown in Figures 3 and 7, the stent graft is at least partially positioned within the aneurysm cavity of an aortic aneurysm 10, such that the coagulant promoting element 200 is located between the aneurysm wall and the outer peripheral surface of the stent graft. The coagulant promoting fibers 210 of the coagulant promoting element 200 slow down the flow rate of blood flowing from the blood inflow channel 21 into the aneurysm cavity, thereby promoting blood coagulation and forming a blood clot. The blood clot forms a space-occupying effect in the aneurysm cavity until the blood clot completely fills the aneurysm cavity, blocking blood flow within the aneurysm cavity, reducing or even preventing type II endoleak, and thereby preventing the continued expansion of the aortic aneurysm. Preferably, the coagulant promoting fibers 210 are cilia that can promote blood clotting.

[0041] It should be understood that the medical stent system further includes an anchoring mechanism 300 , which is connected to one end of the stent graft. The medical stent system is anchored in the blood vessel via the anchoring mechanism 300 .

[0042] When there are branch arteries near the aortic aneurysm 10, for example, please continue to refer to Figure 2, the aortic aneurysm 10 is located in the abdominal aorta 23, and is close to the intersection of the abdominal aorta 23 with the left iliac artery 24 and the right iliac artery 25. Based on this, it is preferred that the medical stent system includes a first sub-stent 110 and two second sub-stents 120. The two second sub-stents 120 are connected in parallel to the same axial end of the first sub-stent 110. Specifically, the anchoring mechanism 300 is provided on one end of the first sub-stent 110, and the two second sub-stents 120 are connected to the end of the first sub-stent 110 away from the anchoring mechanism 300. The two second sub-stents 120 are also respectively connected to the first sub-stent 110. When in use, one second sub-stent 120 at least partially extends into the left iliac artery 24, and the other second sub-stent 120 at least partially extends into the right iliac artery 25.

[0043] When each of the second sub-stents 120 is partially located within the aortic aneurysm 10, the portion of each of the second sub-stents 120 located within the aortic aneurysm 10 is referred to as an embolization segment 121. Thus, the embolization segment 121 is connected to the first sub-stent 110. Therefore, the coagulation promoting member 200 is provided on the outer circumference of the first sub-stent 110 and the outer circumference of each of the embolization segments 121.

[0044] Herein, all the coagulation promoting members 200 disposed on the first sub-support 110 are divided into a plurality of first coagulation promoting assemblies (not labeled in the figure), and all the coagulation promoting members 200 disposed on each of the embolization segments 121 are divided into a plurality of second coagulation promoting assemblies (not labeled in the figure). In other words, a plurality of the first coagulation promoting assemblies are disposed on the first sub-support 110, and a plurality of the second coagulation promoting assemblies are disposed on each of the embolization segments 121. Each of the first coagulation promoting assemblies includes a plurality of the coagulation promoting members 200, and each of the second coagulation promoting assemblies also includes a plurality of the coagulation promoting members 200.

[0045] It is understandable that if there is no branch artery near the aortic aneurysm, the stent graft only includes the first sub-stent but not the second sub-stent (not shown in the figure). That is, the stent graft is a straight-tube stent.

[0046] Next, the optional configuration of the medical stent system will be described by taking the medical stent including the first sub-stent 110, the second sub-stent 120, the first coagulation promoting component and the second coagulation promoting component as an example.

[0047] Optionally, when there are multiple first coagulation promoting components, all of the first coagulation promoting components are arranged at intervals along the circumference of the first sub-support 110. All of the coagulation promoting members 200 of the same first coagulation promoting component are arranged at intervals along the axial direction of the first sub-support 110 and are arranged spirally around the axis of the first sub-support 110. Similarly, at least one second coagulation promoting component is provided on each of the embolization segments 121. When multiple second coagulation promoting members are provided on each of the embolization segments 121, all of the second coagulation promoting members on the same embolization segment 121 are arranged at intervals along the circumference of the corresponding second sub-support 120. All of the coagulation promoting members 200 of the same second coagulation promoting component are arranged at intervals along the axial direction of the corresponding second sub-support 120 and are arranged spirally around the axis of the corresponding second sub-support 120.

[0048] The arrangement of the first coagulant component on the first sub-stent 110 and the arrangement of the second coagulant component on the corresponding second sub-stent 120 reduce the overlap between different coagulant elements 200, avoid knotting of coagulant elements, and allow them to fill the tumor cavity to slow down the flow rate of blood entering the tumor cavity, promote blood clotting in the tumor cavity, and avoid type II endoleak; at the same time, it can reduce the radial dimension of the medical stent system when it is compressed, thereby reducing the resistance of the medical stent system from the delivery system when it is compressed to the delivery system during production and released into the blood vessel during use, thereby improving production stability and safety during surgery.

[0049] The first sub-stent 110 and the second sub-stent 120 have substantially the same configuration. Specifically, each stent graft (including the first sub-stent 110 and the second sub-stent 120) includes a plurality of stent rings 101 and a coating 102. In the corresponding stent graft (the first sub-stent 110 or any one of the second sub-stents 120), the plurality of stent rings 101 are spaced apart along the axial direction thereof, and the coating 102 connects all the stent rings 101. In some embodiments, the coating 102 includes at least an outer coating, which is sutured onto the outer circumference of the corresponding stent ring 101.

[0050] On the first sub-bracket 110, in order to further reduce the degree of overlap between two adjacent coagulation promoting members 200 in the same first coagulation promoting assembly, preferably, there are 1 to 3 bracket rings 101 between two adjacent coagulation promoting members 200 in the same first coagulation promoting assembly. Similarly, on any of the second sub-brackets 120, preferably, there are 1 to 3 bracket rings 101 between two adjacent coagulation promoting members 200 in the same second coagulation promoting assembly.

[0051] In some embodiments, the coagulation-promoting fibers 210 of the coagulation-promoting member 200 are directly connected to the coated stent 100, and the arrangement direction of the multiple coagulation-promoting fibers 210 of each coagulation-promoting member 200 is angled relative to the axis of the corresponding sub-stent. That is, the arrangement direction of the multiple coagulation-promoting fibers 210 of the coagulation-promoting member 200 disposed on the outer circumference of the first sub-stent 110 is tilted relative to the axis of the first sub-stent 110, and the arrangement direction of the multiple coagulation-promoting fibers 210 of the coagulation-promoting member 200 disposed on the outer circumference of the embolization segment is tilted relative to the axis of the corresponding second sub-stent.

[0052] Specifically, in the first coagulation promoting component, all the coagulation promoting fibers 210 of the same coagulation promoting member 200 are arranged along a first predetermined trajectory. On a plane parallel to the axis of the first sub-bracket 110, the projection of the first predetermined trajectory is inclined relative to the projection of the axis of the first sub-bracket 110. Optionally, on a plane parallel to the axis of the first sub-bracket 110, the projection of the first predetermined trajectory forms a third angle α with the projection of the axis of the first sub-bracket 110, and the angle of the third angle α is -45° to 45°. Such an arrangement further reduces the degree of overlap between the coagulation promoting fibers 210 of different coagulation promoting members 200 in the first coagulation promoting component.

[0053] Furthermore, in the second coagulation-promoting assembly, all of the coagulation-promoting fibers 210 of the same coagulation-promoting member 200 are arranged along a second predetermined trajectory. On a plane parallel to the axis of the second sub-support 120, the projection of the second predetermined trajectory is tilted relative to the projection of the axis of the second sub-support 120 to further reduce the overlap between two adjacent coagulation-promoting members 200 in the same second coagulation-promoting assembly. Optionally, on a plane parallel to the axis of the second sub-support 120, the projection of the second predetermined trajectory forms a fourth angle β with the corresponding projection of the axis of the second sub-support 120, with the angle of the fourth angle β being between -45° and 45°.

[0054] The length of the coagulation-promoting fiber 210 of each coagulation-promoting member 200 is determined according to the position of the corresponding coagulation-promoting member 200 in the tumor cavity.

[0055] Specifically, please refer to Figures 2 and 3. The diameter of the aortic aneurysm 10 first increases and then decreases along the axial direction of the abdominal aorta 23. The first sub-stent 110 includes an axially connected first segment 111 and a second segment 112, the end of the first segment 111 away from the second segment 112 is connected to the anchoring mechanism 300, and the end of the second segment 112 away from the first segment 111 is connected to two second sub-stents 120. The second segment 112 is used to be arranged in the middle part of the aortic aneurysm 10, and the first segment 111 and the embolization segment 121 are used to be arranged in the part of the aortic aneurysm 10 close to the axial ends. That is, the second segment 112 is used to be arranged in the part with a relatively large diameter of the aneurysm cavity, while the first segment 111 and the embolization segment 121 are used to be arranged in the part with a relatively small diameter of the aneurysm cavity.

[0056] To match this, the length of the coagulation-promoting fiber 210 of the coagulation-promoting member 200 disposed on the first segment 111 may be shorter than the length of the coagulation-promoting fiber 210 of the coagulation-promoting member 200 disposed on the second segment 112. Furthermore, the length of the coagulation-promoting fiber 210 of the coagulation-promoting member 200 in the second coagulation-promoting assembly may be shorter than the length of the coagulation-promoting fiber 210 of the coagulation-promoting member 200 disposed on the second segment 112. It should be understood that the coagulation-promoting fiber 210 has two opposing ends, one of which is connected to the corresponding sub-stent (the first sub-stent 110 or the second sub-stent 120) and the other end is free. The length of the coagulation-promoting fiber 210 refers to the distance between its two ends when the coagulation-promoting fiber 210 is in a straight line. This arrangement can minimize the raw material consumption of the coagulation-promoting fiber 210 while ensuring that the blood in the tumor cavity can coagulate and block the blood flow in the tumor cavity.

[0057] Optionally, the length of the coagulation-promoting fiber 210 of the coagulation-promoting member 200 disposed on the first segment 111 and the length of the coagulation-promoting fiber 210 of the coagulation-promoting member 200 of the second coagulation-promoting assembly can be 5 mm to 50 mm. The length of the coagulation-promoting fiber 210 of the coagulation-promoting member 200 disposed on the second segment 112 is 50 mm to 100 mm.

[0058] And / or, the number of the coagulation-promoting fibers 210 of the coagulation-promoting member 200 disposed on the second segment 112 is greater than both the number of the coagulation-promoting fibers 210 of the coagulation-promoting member 200 disposed on the first segment 111 and the number of the coagulation-promoting fibers 210 of the coagulation-promoting member 200 of the second coagulation-promoting assembly. This configuration can also ensure that the blood in the tumor cavity can coagulate while minimizing the consumption of the raw materials of the coagulation-promoting fibers 210.

[0059] Optionally, each of the support rings 101 includes a plurality of support ribs (not marked in the figure) connected end to end in sequence, and two adjacent support ribs form a V-shaped structure.

[0060] In some embodiments, the coagulation-promoting fibers 210 of all the coagulation-promoting members 200 of the first coagulation-promoting assembly are sutured to the first sub-stent 110 by sutures. In a preferred implementation, each of the coagulation-promoting members 200 of the first coagulation-promoting assembly is arranged at one of the stent rings 101, and the first predetermined trajectory of each of the coagulation-promoting members 200 overlaps with one of the stent edges, and at the same time, all of the coagulation-promoting fibers 210 of the corresponding coagulation-promoting members 200 are sutured to the stent edges by suturing the coating 102 and the stent ring 101 by the sutures. In this way, the number of suture holes generated by suturing on the coating 102 of the first sub-stent 110 can be reduced. It should be understood that in this case, on a plane parallel to the axis of the first sub-stent 110, the angle formed by the projection of the stent edge in the first sub-stent 110 and the projection of the axis of the first sub-stent 110 is the third angle α.

[0061] In the second coagulation promoting component, the coagulation promoting fibers 210 of each coagulation promoting member 200 are all sewn to the corresponding second sub-support 120 by sutures. Optionally, each coagulation promoting member 200 of the second coagulation promoting component is arranged at one of the support rings 101, and the second predetermined trajectory of each coagulation promoting member 200 overlaps with one of the support edges, and all the coagulation promoting fibers 210 of the corresponding coagulation promoting member 200 are sewn to the support edge by the sutures of sewing the covering 102 and the support ring 101. It should be understood that in this case, on a plane parallel to the axis of the second sub-support 120, the angle formed by the projection of the support edge in the second sub-support 120 and the projection of the axis of the second sub-support 120 is the fourth angle β.

[0062] Furthermore, a pro-coagulant coating (not shown) may be provided on the outer surfaces of the pro-coagulant fibers 210 of at least some of the pro-coagulant members 200 in the above-described embodiment. Preferably, the pro-coagulant coating is provided on the outer surfaces of the shaping portion 220 and the pro-coagulant fibers 210 of all pro-coagulant members 200. The pro-coagulant coating can accelerate clot formation and increase the rate at which blood within the tumor cavity coagulates and fills the tumor cavity. The pro-coagulant coating may comprise a hydrogel.

[0063] In an alternative embodiment, referring to Figures 4 to 6, each of the coagulation-promoting members 200 includes a self-expanding shaping portion 220 and coagulation-promoting fibers 210 attached to the outer surface of the shaping portion 220. One end of the shaping portion 220 is connected to the stent graft 100, and the other end is a free end. The shaping portion 220 is at least partially pre-shaped into a three-dimensional structure. In a typical implementation, the shaping portion 220 is at least partially pre-shaped into a three-dimensional helical structure 221.

[0064] When the medical stent system is implanted within a blood vessel, as shown in Figure 7, the self-expanding shaping portion 220 automatically expands to a configuration having the three-dimensional helical structure 221. Simultaneously, the coagulation-promoting fibers 210 follow the expansion of the shaping portion 220 and freely expand within the tumor cavity, preventing the coagulation-promoting fibers 210 from collapsing under the impact of blood and adhering to the outer surface of the stent graft (including the first sub-stent 110 and the second sub-stent 120). Furthermore, the shaping portion 220 itself can also fill the tumor cavity. In this way, the coagulation-promoting member 200 can effectively promote blood coagulation and increase the speed of blood clotting within the tumor cavity. Furthermore, by arranging the coagulation-promoting fibers 210 in this manner, it can also prevent the coagulation-promoting fibers 210 from becoming tangled due to blood backflow. The shaping portion 220 can be made of a shape memory alloy, such as nickel-titanium alloy, or other highly elastic material, and is pre-shaped to have the configuration having the three-dimensional helical structure 221.

[0065] It should be understood that in these embodiments, the arrangement of the coagulation promoting members 200 is the same as described above. That is, all first coagulation promoting components are arranged at intervals along the circumference of the first sub-stent 110, and all coagulation promoting members 200 of the same first coagulation promoting component are arranged at intervals along the axial direction of the first sub-stent 110 and arranged spirally around the axis of the first sub-stent 110. Furthermore, all second coagulation promoting components located on the same embolization segment 121 are arranged at intervals along the circumference of the corresponding second sub-stent 120, and all coagulation promoting members 200 of the same second coagulation promoting component are arranged at intervals along the axial direction of the corresponding second sub-stent 120 and arranged spirally around the axis of the corresponding second sub-stent 120.

[0066] Furthermore, in the first coagulation promoting component, the axis of the three-dimensional helical structure 221 is tilted relative to the axis of the first sub-bracket 110. Also, in the second coagulation promoting component, the axis of the three-dimensional helical structure 221 of the shaping portion 220 is tilted relative to the corresponding axis of the second sub-bracket 120.

[0067] In the first coagulation promoting component, the axis of the three-dimensional helical structure 221 of the coagulation promoting component 200 forms a first angle γ with the axis of the first sub-support 110, and the angle of the first angle γ is -45° to 45°. In the second coagulation promoting component, the axis of the three-dimensional helical structure 221 of the coagulation promoting component 200 forms a second angle δ with the axis of the second sub-support 120 connected thereto, and the angle of the second angle δ is -45° to 45°.

[0068] In these embodiments, the axial length of the shaping portion 220 connected to the second segment 112 is greater than the axial length of the shaping portion 220 connected to the first segment 111, and is also greater than the axial length of the shaping portion 220 connected to the second sub-stent 120. The axial direction of the shaping portion 220 refers to the axial direction of the three-dimensional helical structure 221 of the shaping portion 220.

[0069] Optionally, the shaped portion 220 connected to the first segment 111 has an axial length of 5 mm to 20 mm, and the shaped portion 220 connected to the second segment 112 has an axial length of 15 mm to 50 mm. The shaped portion 220 connected to the second sub-stent 120 has an axial length of 5 mm to 20 mm. In this way, the coagulant-promoting elements 200 located at various locations within the tumor cavity can fully fill the tumor cavity, effectively slowing the flow rate of blood within the tumor cavity and promoting blood clotting. In these embodiments, at least some of the shaped portions 220 and / or the coagulant-promoting fibers 210 of the coagulant-promoting elements 200 are further provided with a coagulant-promoting coating (not shown in the figures) on their outer surfaces. Preferably, the shaped portions 220 and the coagulant-promoting fibers 210 of all the shaped portions 220 and the coagulant-promoting fibers 210 of the coagulant-promoting elements 200 are provided with the coagulant-promoting coating on their outer surfaces. The provision of the coagulant-promoting coating can accelerate the formation of blood clots and increase the speed at which the blood within the tumor cavity coagulates and fills the tumor cavity. The coagulant-promoting coating may include a hydrogel.

[0070] In summary, the medical stent system provided in the embodiments of the present invention, by disposing a coagulant-promoting member on the outer circumferential surface of the stent graft, can utilize the coagulant-promoting member to slow blood flow in the aneurysm cavity during aneurysm treatment, promoting blood clots and thereby filling the aneurysm cavity, thereby reducing the occurrence of type II endoleak. In particular, when the coagulant-promoting member includes a shaping portion and coagulant-promoting fibers attached thereto, the shaping portion can prevent the coagulant-promoting fibers from collapsing and adhering to the stent graft, thereby allowing the coagulant-promoting member to effectively fill the aneurysm cavity and further promoting blood clotting within the aneurysm cavity.

[0071] While the present invention is disclosed above, it is not limited thereto. Those skilled in the art may make various modifications and variations to the present invention without departing from the spirit and scope of the present invention. Thus, the present invention is intended to encompass such modifications and variations as long as they fall within the scope of the claims and their equivalents.

Claims

1. A medical stent system, characterized in that: It comprises a stent graft and a coagulant member arranged on the outer peripheral surface of the stent graft, wherein the coagulant member comprises a plurality of coagulant fibers for filling the tumor cavity to slow down the flow rate of blood entering the tumor cavity and promote blood coagulation in the tumor cavity.

2. The medical stent system according to claim 1, characterized in that: The coagulation promoting member also includes a self-expanding shaping portion, the coagulation promoting fiber is attached to the shaping portion, one end of the shaping portion is connected to the stent graft, and the other end is a free end; the shaping portion is at least partially pre-shaped into a three-dimensional structure.

3. The medical stent system according to claim 1 or 2, characterized in that: All the coagulation-promoting components are divided into a plurality of coagulation-promoting components, and each of the coagulation-promoting components includes a plurality of the coagulation-promoting components; All the coagulation promoting components are arranged at intervals along the circumference of the coated stent; all the coagulation promoting elements of the same coagulation promoting component are arranged at intervals along the axial direction of the coated stent and are arranged spirally around the axis of the coated stent.

4. The medical stent system according to claim 1 or 2, characterized in that: The coated stent includes a first sub-stent and two second sub-stents, the two second sub-stents are connected in parallel to the same axial end of the first sub-stent and are respectively connected to the first sub-stent; some segments of the second sub-stent are embolic segments; the coagulation promoter is provided on the outer peripheral surface of the first sub-stent and the outer peripheral surface of each of the embolic segments.

5. The medical stent system according to claim 4, characterized in that: All the coagulants arranged on the first sub-bracket are divided into a number of first coagulant assemblies, each of which includes a plurality of coagulant assemblies; all the first coagulant assemblies are arranged at intervals along the circumference of the first sub-bracket; all the coagulants of the same first coagulant assembly are arranged at intervals along the axial direction of the first sub-bracket and are arranged spirally around the axis of the first sub-bracket.

6. The medical stent system according to claim 5, characterized in that: The first sub-support comprises a plurality of support rings spaced apart along the axial direction thereof, and there are 1 to 3 support rings spaced apart between two adjacent coagulation promoting members of the same first coagulation promoting component.

7. The medical stent system according to any one of claims 4 to 6, characterized in that: All the coagulants on each of the embolization segments are divided into a number of second coagulant components, and each of the second coagulant components includes a plurality of the coagulants; all the second coagulant components on the same embolization segment are arranged at intervals along the circumference of the corresponding second sub-branch; all the coagulants of the same second coagulant component are arranged at intervals along the axial direction of the corresponding second sub-branch and are arranged spirally around the axis of the corresponding second sub-branch.

8. The medical stent system according to claim 7, characterized in that: Each of the second sub-supports comprises a plurality of support rings spaced apart along the axial direction thereof, and there are 1 to 3 support rings spaced apart between two adjacent coagulation promoting members of the same second coagulation promoting component.

9. The medical stent system according to claim 4, characterized in that: The coagulation promoting member disposed on the outer peripheral surface of the first sub-support is inclined relative to the axis of the first sub-support.

10. The medical stent system according to claim 4 or 9, characterized in that: The coagulation promoting member disposed on the outer peripheral surface of the embolization segment is inclined relative to the axis of the corresponding second sub-stent.

11. The medical stent system according to claim 4, characterized in that: The first sub-bracket comprises a first segment and a second segment connected axially, and one end of the second segment away from the first segment is connected to two second sub-brackets; The length of the coagulation-promoting fiber of the coagulation-promoting member arranged on the first segment is 5 mm to 50 mm, and the length of the coagulation-promoting fiber of the coagulation-promoting member arranged on the second segment is 50 mm to 110 mm; The length of the coagulation-promoting fibers of the coagulation-promoting member arranged on the second sub-support is 5 mm to 50 mm.

12. The medical stent system according to claim 4 or 11, characterized in that: The number of the coagulation-promoting fibers of each of the coagulation-promoting elements arranged on the first segment is smaller than the number of the coagulation-promoting fibers of each of the coagulation-promoting elements arranged on the second segment; the number of the coagulation-promoting fibers of each of the coagulation-promoting elements arranged on the second segment is larger than the number of the coagulation-promoting fibers of each of the coagulation-promoting elements arranged on the second sub-bracket.

13. The medical stent system according to claim 2, characterized in that: The coated stent comprises a first sub-stent and two second sub-stents, the two second sub-stents are connected in parallel to the same axial end of the first sub-stent and are respectively connected to the first sub-stent; the first sub-stent comprises an axially connected first segment and a second segment, the second segment is connected to the two second sub-stents at one end away from the first segment; some segments of the second sub-stent are embolization segments; the coagulation promoter is provided on the outer peripheral surface of the first sub-stent and the outer peripheral surface of each of the embolization segments; The axial length of the shaping portion of the coagulation promoter arranged on the first segment is 5mm to 20mm, and the axial length of the shaping portion of the coagulation promoter arranged on the second segment is 15mm to 50mm; and / or the axial length of the shaping portion arranged on the embolization segment is 5mm to 20mm.

14. The medical stent system according to claim 1 or 2, characterized in that: A coagulation-promoting coating is provided on at least a portion of the outer surface of the coagulation-promoting member.

Citation Information

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