A valve stent and a prosthetic valve assembly

Abstract

The present application discloses a valve stent and a prosthetic valve assembly, wherein the valve stent comprises an inner stent and an outer stent connected to each other; the inner stent comprises at least two first extensions, the first extensions face the outer stent and form a first angle with the inner stent; the outer stent comprises at least two second extensions, the second extensions face the inner stent and form a second angle with the outer stent; each first extension is correspondingly connected to the second extension; at least one of the first angle and the second angle is not a right angle. In the above manner, the present application can enhance the anchoring effect of the valve stent on native heart tissue.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a valve stent and a prosthetic valve assembly. Background Art

[0002] Heart valve disease is a very common heart disease, such as valve damage caused by rheumatic fever. With the aging of the population, senile valvular disease and valvular lesions caused by myocardial infarction after coronary heart disease are becoming more and more common. These valvular lesions not only endanger life safety and affect the quality of life, but also bring serious burden and pressure to families and society.

[0003] Currently, heart valve replacement surgery can be used to implant a valve prosthesis into the diseased heart valve through an interventional, minimally invasive method to replace the patient's original diseased heart valve. However, due to the high blood flow pressure between the atrium and ventricle, the valve stent is prone to displacement. Summary of the invention

[0004] The main technical problem solved by the present application is to provide a valve stent and a prosthetic valve assembly, which can enhance the anchoring effect of the valve stent on the native heart tissue.

[0005] In order to solve the above technical problems, a technical solution adopted in the present application is: to provide a valve stent, which includes an inner stent and an outer stent connected to each other, the inner stent includes at least two first extensions, the first extensions face the outer stent and form a first angle with the inner stent; the outer stent includes at least two second extensions, the second extensions face the inner stent and form a second angle with the outer stent; each first extension is correspondingly connected to the second extension; at least one of the first angle and the second angle is not a right angle.

[0006] Wherein, the valve stent also includes a connecting piece, which is sleeved on the ends of the first extension part and the second extension part and is used to connect and fix the first extension part and the second extension part.

[0007] The first extension portion and the second extension portion are connected by any one or more combinations of welding, flat pressing, tooth pressing, and riveting.

[0008] Among them, the first angle is 30°-60°, and the second angle is 30°-60°.

[0009] Wherein, the first angle is equal to the second angle.

[0010] The outer stent also includes a main body, a skirt structure, a transition rod and an anchoring assembly. The transition rod connects the skirt structure and the main body. The anchoring assembly includes a plurality of barbs arranged on the outer stent and extending radially outward. The barbs are used to anchor the valve stent to the heart.

[0011] The outer support also includes an auxiliary anchoring assembly, which is connected to the skirt structure and is located between any two transition rods to provide radial force to the outer support.

[0012] Among them, the stiffness of the inner bracket is greater than the stiffness of the outer bracket.

[0013] Among them, the valve stent is a mitral valve stent or a tricuspid valve stent.

[0014] In order to solve the above technical problems, another technical solution adopted in the present application is: to provide a prosthetic valve assembly, which includes a prosthetic valve and the above valve stent that are connected to each other.

[0015] The beneficial effects of the present application are as follows: different from the prior art, the present application provides a valve stent, which includes an inner stent and an outer stent connected to each other; the inner stent includes at least two first extensions facing the outer stent and forming a first angle with the inner stent, and the outer stent includes at least two second extensions facing the inner stent and forming a second angle with the outer stent, each first extension is correspondingly connected to the second extension, and at least one of the first angle and the second angle is not a right angle; the connection and fixation of the inner stent and the outer stent are achieved by connecting the first extension and the second extension, and by setting the angles of the first extension and the second extension, the force of the connecting structure can be adjusted, so that the connecting structure can provide radial support force to the outer stent, thereby assisting in enhancing the anchoring effect of the valve stent on the native heart tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a front view structural schematic diagram of an embodiment of the valve stent of the present application;

[0017] Figure 2 This is an axonometric structural diagram of an embodiment of the valve stent of the present application;

[0018] Figure 3 It is a simplified structural schematic diagram of an embodiment of the valve stent of the present application;

[0019] Figure 4 It is a simplified schematic diagram of the connection structure between the inner bracket and the outer bracket of the present application;

[0020] Figure 5 It is a cross-sectional schematic diagram of the connection structure of the inner bracket and the outer bracket of the present application;

[0021] Figure 6 It is an axonometric schematic diagram of another connection structure between the inner bracket and the outer bracket of the present application;

[0022] Figure 7 is another cross-sectional schematic diagram of the connection structure between the inner bracket and the outer bracket of the present application;

[0023] Figure 8 It is a schematic diagram of the top view of the structure of an embodiment of the valve stent of the present application;

[0024] Fig. 9 It is a front view structural schematic diagram of another embodiment of the valve stent of the present application;

[0025] Fig.10 It is an axonometric structural schematic diagram of another embodiment of the valve stent of the present application;

[0026] Fig.11 It is a schematic diagram of the implantation of the prosthetic valve assembly of the present application into the heart. DETAILED DESCRIPTION

[0027] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments of the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0028] It should be noted that if there are descriptions involving "first", "second", etc. in the embodiments of the present application, the descriptions of "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or suggesting their relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In addition, the technical solutions between the various embodiments can be combined with each other, but they must be based on the ability of ordinary technicians in the field to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such combination of technical solutions does not exist and is not within the scope of protection required by this application.

[0029] In order to make the purpose, technical solution and effect of the present application clearer and more specific, the present application is further described in detail below with reference to the accompanying drawings and examples.

[0030] The present application provides a valve stent, which includes an inner stent and an outer stent that are connected to each other; the inner stent includes at least two first extensions facing the outer stent and forming a first angle with the inner stent, and the outer stent includes at least two second extensions facing the inner stent and forming a second angle with the outer stent, each first extension is correspondingly connected to the second extension, and at least one of the first angle and the second angle is not a right angle; the connection and fixation of the inner stent and the outer stent are achieved by connecting the first extension and the second extension, and by setting the angles of the first extension and the second extension, the force of the connection structure can be adjusted, so that the connection structure can provide radial support force to the outer stent, thereby assisting in enhancing the anchoring effect of the valve stent on the native heart tissue and improving the fit between the valve stent and the native heart tissue.

[0031] See also Figure 1-Figure 2 , Figure 1 1 is a front view structural diagram of an embodiment of the valve stent of the present application. Figure 2 This is an isometric structural diagram of an embodiment of the valve stent of the present application. The present application provides a valve stent 100, which can support prosthetic leaflets and can be regarded as a frame structure supporting the prosthetic leaflets. During the contraction and expansion of the heart, the normal operation of the prosthetic leaflets is ensured to be unaffected. The prosthetic leaflets supported by the valve stent 100 are relatively fixed to the native heart tissue, so that the prosthetic leaflets can help repair and / or replace the function of the defective native heart valve.

[0032] The valve stent 100 includes an inner stent 110 and an outer stent 130 that are interconnected, forming a main frame structure that supports the prosthetic leaflets. The inner stent 110 is used to position and install the prosthetic leaflets, and can support the normal operation of the prosthetic leaflets; the outer stent 130 can be anchored and connected to the native valve ring area, so that the valve stent 100 is relatively fixed to the native heart tissue, and the valve stent 100 fits the native heart tissue. The valve stent 100 can be a mitral valve stent or a tricuspid valve stent, which is not specifically limited here.

[0033] Optionally, the rigidity of the inner support 110 is greater than that of the outer support 130. The inner support 110 supports the prosthetic leaflets, and is relatively hard compared to the outer support 130, so that it is not easy to deform when compressed or squeezed, thereby ensuring that the normal operation of the prosthetic leaflets disposed therein is not affected; the outer support 130 protects the inner support 110 to a certain extent, and is relatively soft, so that the pressure on the inner support 110 generated when the prosthetic leaflets are closed can be reduced.

[0034] Optionally, the inner support 110 and the outer support 130 may be formed by laser cutting of one or more tubes, which are not specifically limited here. Preferably, they are shape memory metal tubes, such as nickel titanium alloy, etc. The valve support 100 made of shape memory metal tubes can automatically expand from a compressed state, that is, the valve support 100 made of shape memory metal tubes is easier to automatically expand from a contracted or constrained structural state to an expanded or used structural state. In other embodiments, the inner support 110 and the outer support 130 may also be made of wires, such as shape memory metal wires, etc., which can be specifically set according to the actual application scenario, which is not specifically limited here.

[0035] See also Figure 3-Figure 4 , Figure 3 It is a simplified structural schematic diagram of an embodiment of the valve stent of the present application. Figure 4 It is a simplified schematic diagram of the connection structure of the inner support and the outer support of the present application. The inner support 110 provided in the present application has at least two first extensions 111, the first extensions 111 extend toward the outer support 130, and form a first angle α with the inner support 110; at the same time, the outer support 130 provided in the present application has at least two second extensions 131, the second extensions 131 extend toward the inner support 110, and form a second angle β with the outer support 130; the first extension 111 and the second extension 131 are connected to form a connection part 200, and at least one of the first angle α and the second angle β is not a right angle. By adjusting the specific angles of the first angle α and the second angle β, the connection part 200 can give the outer support 130 a radial support force, thereby enhancing the anchoring effect of the valve support 100 on the native heart tissue, improving the fit of the valve support 100 with the native heart tissue, and preventing paravalvular leakage. The length L of the connection part 200 can be specifically set in the actual application scenario, and is not specifically limited here. In one embodiment, the valve stent 100 includes at least two connecting portions 200 formed by a first extension portion 111 and a second extension portion 131, and the at least two connecting portions 200 are evenly distributed in the circumferential direction, so that the anchoring effect of the valve stent 100 on the native heart tissue is more stable.

[0036] Optionally, the first angle α and the second angle β are not right angles, and the first angle α and the second angle β may be set to be acute angles, such as Figure 3 As shown, by setting the first angle α and the second angle β to acute angles, the connection structure can be Z-shaped. The Z-shaped connection structure can provide the outer stent 130 with a stable radial support force, assist in enhancing the anchoring effect of the valve stent 100 on the native heart tissue, and improve the fit between the valve stent 100 and the native heart tissue.

[0037] Specifically, Figure 3As shown, the native heart tissue contracts and expands during the cardiac cycle, generating a force of magnitude F, which compresses the outer support 130 in the valve support 100, causing the relative position of the outer support 130 and the native heart tissue to change. Since the inner support 110 and the outer support 130 are relatively fixed, the relative position of the inner support 110 and the native heart tissue also changes, so that the prosthetic leaflet supported on the valve support 100 cannot play a corresponding role. By adjusting the angles of the first angle α and the second angle β, the first extension portion 111 and the second extension portion 131 form a Z-shaped connection structure, and the Z-shaped connection structure can give the outer support 130 a radial support force f. When the valve stent 100 is compressed, the radial supporting force f can balance the compressive force F exerted on the valve stent 100, so that the valve stent 100 will move synchronously with the movement of the native heart tissue, ensuring that the relative position of the valve stent 100 and the native heart tissue remains unchanged, that is, the valve stent 100 does not undergo relative displacement relative to the native heart tissue, thereby helping to enhance the anchoring effect of the valve stent 100 on the native heart tissue, improving the fit between the valve stent 100 and the native heart tissue, and preventing paravalvular leakage.

[0038] Optionally, the first angle α is 30°-60°, and the second angle β is 30°-60°. The specific degrees of the first angle α and the second angle β can be determined according to actual use needs, and are not specifically limited here. The first angle α and the second angle β are acute angles, and can also be regarded as obtuse angles from another angle. Specifically, taking the second angle β as an example, Figure 4 As shown, the second extension portion 131 extends from point O on the outer bracket 130 toward the inner bracket 110 and forms a second angle β with the outer bracket 130. The second angle β can be regarded as an angle formed by the second extension portion 131 and the OB segment on the outer bracket 130, that is, an acute angle, or can be regarded as an angle formed by the second extension portion 131 and the OA segment on the outer bracket 130, that is, an obtuse angle.

[0039] Furthermore, the Z-shaped connection structure formed by the first extension portion 111 and the second extension portion 131 can reduce the axial length of the valve stent 100 body, thereby avoiding obstruction of the ventricular outflow tract due to the excessive axial length of the valve stent 100; during the cardiac cycle of the native heart, the radial expansion of the valve ring changes greatly, and the connection position between the outer stent 130 and the inner stent 110 is far away from the native valve ring area, which can avoid the influence of the radial expansion of the valve ring on the normal operation of the inner stent 110.

[0040] See also Figure 5 , Figure 52 is a schematic cross-sectional view of the connection structure of the inner bracket and the outer bracket of the present application. In this embodiment, the first extension portion 111 and the second extension portion 131 are overlapped and connected to form a connection portion 200. That is, starting from the ends of the first extension portion 111 and the second extension portion 131, part of the first extension portion 111 and part of the second extension portion 131 are overlapped and connected to achieve the connection and fixation of the inner bracket 110 and the outer bracket 130. In other embodiments, the first extension portion 111 and the second extension portion 131 can also be fixedly connected end to end, which is not specifically limited here.

[0041] Optionally, the overlapping connection of the first extension portion 111 and the second extension portion 131 can be fixed by welding, flat pressing, tooth pressing or riveting, etc., which are not specifically limited here. For example, taking welding as an example, the end of the first extension portion 111 and the end of the second extension portion 131 are welded together in an overlapping manner by heating, high temperature or high pressure in combination with a welding agent.

[0042] Among them, Figure 5 As shown, the ends of the first extension portion 111 and the second extension portion 131 are offset and overlapped to form a connecting portion 200, and at the connecting portion 200, a first coupling member 170 is provided between the first extension portion 111 and the second extension portion 131, and the ends of the first extension portion 111 and the second extension portion 131 are connected together by the first coupling member 170.

[0043] Please continue reading Figure 5 The valve stent 100 further includes a connector 150, which is sleeved on the ends of the first extension portion 111 and the second extension portion 131 to connect and fix the first extension portion 111 and the second extension portion 131. In other words, the connecting portion 200 of the first extension portion 111 and the second extension portion 131 is covered with the connector 150 to make the connection between the first extension portion 111 and the second extension portion 131 more stable, thereby providing the valve stent 100 with a larger and more stable radial support force. It can be understood that the connector 150 can be a fastener such as a sleeve, and the connector 150 can be interference fit with the first extension portion 111 and the second extension portion 131 to enhance the stability of the connection. The specific selection and setting can be based on actual use needs, and no specific limitation is made here.

[0044] See also Figure 6-Figure 7 , Figure 6 It is an axonometric diagram of another connection structure between the inner bracket and the outer bracket of the present application. Figure 7It is a cross-sectional schematic diagram of another connection structure of the inner bracket and the outer bracket of the present application. In this embodiment, the ends of the first extension portion 111 and the second extension portion 131 are nested and connected to form a connection portion 200. Among them, at least one groove is provided at the end of one of the first extension portion 111 and the second extension portion 131, and the end of the other extension portion is configured to match the groove. For example, at least one groove is provided at the end of the first extension portion 111, and the end of the second extension portion 131 is embedded in the groove of the first extension portion 111, and is matched and connected with the groove of the first extension portion 111, so as to realize the connection and fixation of the first extension portion 111 and the second extension portion 131. In other embodiments, at least one groove may be provided at the end of the second extension portion 131, and the end of the first extension portion 111 is embedded in the groove of the second extension portion 131, and is matched and connected with the groove of the second extension portion 131.

[0045] Specifically, Figure 6 As shown, the end of the first extension portion 111 can be regarded as a rivet with a certain width; the second extension portion 131 can be regarded as a connected part (riveted part), and a nail hole is provided on the connected part; the end surface area of ​​the end of the first extension portion 111 is larger than the end surface area of ​​the end of the second extension portion 131, and the width of the rivet is greater than or equal to the inner diameter of the nail hole, so that the rivet is fixedly connected to the connected part through the nail hole of the connected part, that is, the ends of the first extension portion 111 and the second extension portion 131 are connected and fixed similar to riveted parts, thereby forming a connecting portion 200, which can give the external support 130 an outward radial supporting force to ensure that the relative position of the valve support 100 and the native heart tissue remains unchanged, thereby assisting in enhancing the anchoring effect of the valve support 100 on the native heart tissue and improving the fit between the valve support 100 and the native heart tissue.

[0046] In this embodiment, the second extension portion 131 is connected to the two opposite sides of the first extension portion 111, and the inner side of the second extension portion 131 fits the two opposite sides of the first extension portion 111, so that the connection between the first extension portion 111 and the second extension portion 131 is tighter and more stable. Compared with the connection method of the first extension portion 111 and the second extension portion 131 in the above embodiment, the connection method of the first extension portion 111 and the second extension portion 131 in this embodiment can effectively reduce the volume of the sheath or conveyor to be installed, so that the valve stent 100 can be delivered and implanted in the atrium and / or ventricle in a minimally invasive manner (for example, through the apex, through the ventricle, through the atrium, through the septum, etc.) more easily.

[0047] Furthermore, the outer side of the connecting portion 200 is sleeved with a connecting piece 150, so that the stability of the connecting portion 200 formed by the overlapping of the first extension portion 111 and the second extension portion 131 is improved, thereby providing a larger and more stable radial support force for the outer bracket 130. In addition, at the connecting portion 200, a second coupling member 190 is provided between the opposite sides of the second extension portion 131 and the connecting piece 150, and cooperates to complete the welding and other operations of fixing the connecting piece 150 to the connecting portion 200.

[0048] Please refer to Figure 1-2 and Figure 8 , Figure 8 1 is a schematic diagram of a top view of an embodiment of the valve stent of the present application. The valve stent 100 includes an inner stent 110. The valve stent 100 is opened to extend the inner stent 110, and the valve stent 100 is closed to shrink the inner stent 110. Figure 8 As shown, the inner support 110 is generally cylindrical, and the diameter of the cylinder may be between 28 and 35 mm. Figure 1 , 2 As shown, the inner support 110 includes a first extending portion 111 , a hanging portion 115 and a stabilizing portion 117 .

[0049] The inner support 110 is provided with a prosthetic leaflet, which is movable when blood flows. The hanging flap portion 115 is used to sew the prosthetic leaflet to the region where the prosthetic leaflet can be arranged in the inner support 110, so that the prosthetic leaflet is connected to the inner support 110. The stabilizing portion 117 can keep the structure of the entire inner support 110 stable after the prosthetic leaflet is sewn in the inner support 110.

[0050] Specifically, the number of prosthetic leaflets in the inner support 110 can be 2, 3, etc., which are not specifically limited here. When the number of prosthetic leaflets is an even number, the prosthetic leaflets can be distributed symmetrically along the circumferential direction of the inner surface of the inner support 110; when the number of prosthetic leaflets is an odd number, the prosthetic leaflets can be evenly arranged at equal intervals along the circumferential direction of the inner surface of the inner support 110; two adjacent prosthetic leaflets are combined together near one end of the inner support 110 to form a valve angle. When the native heart tissue begins a contraction cycle, the prosthetic leaflets move in the same direction according to the direction of blood flow. Without damaging the prosthetic leaflets, the prosthetic leaflets form as large an opening as possible in the inner support 110 to allow blood to flow from one chamber of the heart to another chamber or to the outside of the heart. When the contraction cycle of the native heart tissue ends, the blood will immediately flow in the opposite direction, pushing the valve leaflets from the opposite direction to close the prosthetic leaflets, blocking retrograde blood flow or preventing blood reflux. That is, the prosthetic leaflet acts as a one-way valve in the inner stent 110, allowing blood to move in only one direction (for example, from the left atrium to the left ventricle) and blocking the backflow or reflux of blood.

[0051] Optionally, the inner support 110 may also be provided with installation positioning holes to facilitate the positioning and installation of the prosthetic leaflets on the inner support 110, so that the prosthetic leaflets supported by the valve support 100 can help repair and / or replace the function of the defective native heart valve.

[0052] Please continue to refer to Figure 1-2 and Figure 8 The valve stent 100 further includes an outer stent 130 fixedly connected to the inner stent 110, and the outer stent 130 includes a second extension portion 131, a main body 132, a skirt structure 133, a transition rod 135, and an anchoring assembly 137. The transition rod 135 connects the skirt structure 133 and the main body 132; the anchoring assembly 137 anchors the native valve ring area, so that the valve stent 100 is connected to the native heart tissue, so that the prosthetic leaflet can help repair and / or replace the function of the defective native heart valve.

[0053] like Figure 1 , 2 As shown, the skirt structure 133 as a whole may be roughly in the shape of a flower, connected to the main body 132 through a transition rod 135, and the skirt structure 133 between two adjacent transition rods 135 may have a variety of pleated shapes. Figure 1 , 2 As shown, the skirt structure 133 can be W-shaped, so that the skirt structure 133 can adapt to the physiological structure of the mitral valve or tricuspid valve, that is, it can enable the external support 130 to better fit the native valve ring with a D-shaped appearance, and it is easier to form a D-shape or adapt to the anatomical structure, which is more consistent with the actual mitral valve anatomical structure, reduce the pressure on the aorta, and prevent paravalvular leakage.

[0054] Optionally, in order to better fit the cardiac myocardial tissue and not increase the resistance of the valve stent 100 entering the sheath, the shape of the skirt structure 133 can be specifically set according to actual applications, and is not specifically limited here.

[0055] Please continue reading Figure 1-Figure 2 In this embodiment, the anchoring component 137 includes a plurality of barb structures arranged on the outer stent 130 and extending radially outward, so that the valve stent 100 can penetrate into the native heart tissue through the barb structure, and anchor with the native valve ring and leaflet tissue, thereby fixing the valve stent 100 on the heart, which can improve the fit between the valve stent 100 and the heart, and can restrain the axial freedom of the valve stent 100 under the tension of the native valve, thereby effectively reducing the probability of displacement of the valve stent 100 after implantation.

[0056] Among them, the barb structure includes at least two types, one is the proximal barb 1371 close to the valve ring position, that is, the barb structure close to the heart; the other is the distal barb 1373 close to the valve leaflet position, that is, the barb structure far away from the heart; the proximal barb 1371 and the distal barb 1373 are opposite to each other. By setting a bidirectional barb structure, the proximal barb 1371 is inserted into the native valve ring and the distal barb 1373 is inserted into the native valve leaflet tissue, so that the anchoring effect on the native valve ring and the valve leaflet tissue is more stable, effectively reducing the probability of displacement of the valve stent 100 relative to the native heart tissue, and ensuring the possibility of actual operation. Optionally, the proximal barb 1371 and the distal barb 1373 can be straight lines, curves or other shapes, which are not specifically limited here.

[0057] See also Figure 9-10 , Fig. 9 is a front view structural schematic diagram of another embodiment of the valve stent of the present application, Fig.10 This is an isometric structural diagram of another embodiment of the valve stent of the present application. The outer stent 130 may also include an auxiliary anchoring assembly 139, which is located between any two transition rods 135 and connected to the skirt structure 133 to increase the outward radial support force, further enhance the anchoring effect of the valve stent 100 on the native heart tissue, improve the fit between the valve stent 100 and the native heart tissue, and repair the defective native heart valve structure to enable it to expand again.

[0058] In another embodiment, the present application further provides a prosthetic valve assembly, which includes a prosthetic valve and the valve stent 100 in the above embodiment that are connected to each other.

[0059] Optionally, the prosthetic valve can be a prosthetic leaflet, which is a thin layer of material, usually made of homologous or heterologous biomaterials, such as porcine pericardium, bovine pericardium, etc., or made of artificial ultra-high molecular weight polyethylene, nylon mixture, polymer materials. The prepared prosthetic leaflet is durable and not affected by tensile deformation or fatigue.

[0060] The number of prosthetic leaflets can be one, two, or more, etc., and is not specifically limited here.

[0061] The valve stent 100 can support the prosthetic leaflets and can be regarded as a frame structure supporting the prosthetic leaflets. The valve stent 100 is anchored and connected to the native valve ring area, so that the prosthetic leaflets supported by the valve stent 100 are relatively fixed to the native heart tissue and more closely fit the native heart tissue, so that the prosthetic leaflets can help repair and / or replace the function of a defective native heart valve.

[0062] See also Fig.11 , Fig.11It is a schematic diagram of the implantation of the prosthetic valve assembly of the present application into the heart. In one embodiment, the valve stent 100 can be a mitral valve stent, which can be delivered in a minimally invasive manner (e.g., transapical, transventricular, transatrial, transseptal, etc.) and implanted in the atrium and / or ventricle. When subjected to the compressive force generated by the native heart tissue during the cardiac cycle, the Z-shaped connection structure in the valve stent 100 can provide a radial support force that can balance the compressive force on the valve stent 100, so that the valve stent 100 will move synchronously with the native heart tissue, ensuring that the relative position of the valve stent 100 and the native heart tissue remains unchanged, thereby assisting in enhancing the anchoring effect of the valve stent 100 on the native heart tissue, improving the fit of the valve stent 100 and the native heart tissue, and preventing paravalvular leakage. In addition, the external stent 130 uses a structural design with a relatively large opening area at the valve ring anchoring point, which can effectively reduce the pressure of the external stent 130 on the native valve ring and cause corresponding functional damage to the heart's contraction and relaxation, thereby increasing the implantation success rate of the prosthetic valve assembly.

[0063] Different from the prior art, the present application provides a valve stent and a prosthetic valve assembly. The valve stent includes an inner stent and an outer stent; the inner stent includes at least two first extensions facing the outer stent and forming a first angle with the inner stent, and the outer stent includes at least two second extensions facing the inner stent and forming a second angle with the outer stent, each first extension is connected to the second extension, and at least one of the first angle and the second angle is not a right angle; the connection and fixation of the inner stent and the outer stent are achieved by connecting the first extension and the second extension, and the angle formed by the first extension and the inner stent and the angle formed by the second extension and the outer stent are set, so that the first extension and the second extension form a Z-shaped connection structure, and the Z-shaped connection structure can give the outer stent a radial support force. When subjected to the compressive force generated by the native heart tissue during the cardiac cycle, the radial support force can balance the compressive force on the valve stent, so that the valve stent will move synchronously with the native heart tissue, ensuring that the relative position of the valve stent and the native heart tissue remains unchanged, thereby assisting in enhancing the anchoring effect of the valve stent on the native heart tissue, improving the fit between the valve stent and the native heart tissue, and preventing paravalvular leakage.

[0064] The above description is only an implementation method of the present application, and does not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made using the contents of the present application specification and drawings, or directly or indirectly used in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. A valve stent, characterized in that: The valve support comprises: Interconnected inner and outer brackets; The inner bracket includes at least two first extensions, the first extensions face the outer bracket and form a first angle with the inner bracket; the outer bracket includes at least two second extensions, the second extensions face the inner bracket and form a second angle with the outer bracket; each first extension is correspondingly connected to the second extension; The first angle and the second angle are both acute angles.

2. The valve stent according to claim 1, characterized in that: The valve stent also includes a connector, which is sleeved on the ends of the first extension portion and the second extension portion and is used to connect and fix the first extension portion and the second extension portion.

3. The valve stent according to claim 1, characterized in that: The first extension portion and the second extension portion are connected by any one or more combinations of welding, flat pressing, tooth pressing, and riveting.

4. The valve stent according to claim 1, characterized in that: The first angle is 30°-60°, and the second angle is 30°-60°.

5. The valve stent according to claim 4, characterized in that: The first angle is equal to the second angle.

6. The valve stent according to claim 1, characterized in that: The outer stent also includes a main body, a skirt structure, a transition rod and an anchoring assembly, wherein the transition rod connects the skirt structure and the main body, and the anchoring assembly includes a plurality of barbs arranged on the outer stent and extending radially outward, and the barbs are used to anchor the valve stent on the heart.

7. The valve stent according to claim 6, characterized in that: The outer support also includes an auxiliary anchoring assembly, which is connected to the skirt structure and is located between any two transition rods to provide radial force to the outer support.

8. The valve stent according to claim 1, characterized in that: The rigidity of the inner support is greater than the rigidity of the outer support.

9. The valve stent according to claim 1, characterized in that: The valve stent is a mitral valve stent or a tricuspid valve stent.

10. A prosthetic valve assembly, characterized in that: The prosthetic valve assembly comprises a prosthetic valve and a valve stent as described in any one of claims 1-9 that are connected to each other.

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