A valve stent and a prosthetic valve assembly

Abstract

The present application discloses a valve stent and a prosthetic valve assembly. The valve stent includes a valve stent body and at least two anchoring portions; the valve stent body includes a leaflet stent and a skirt stent that are connected to each other; the anchoring portions are connected to the valve stent body and are located outside the valve stent body, and the anchoring portions include a first anchoring member and a second anchoring member; wherein, axially, the orthographic projection of the first anchoring member on the valve stent body at least partially coincides with the orthographic projection of the second anchoring member on the valve stent; radially, the first anchoring member and the second anchoring member have a first state and a second state. In the first state, the first anchoring member in the overlapping region is closer to the valve stent body than the second anchoring member, and in the second state, the first anchoring member in the overlapping region is farther from the valve stent body than the second anchoring member. In the above manner, the present application can make the anchoring connection between the valve stent and the heart tissue more stable.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a valve stent and a prosthetic valve assembly. Background Art

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

[0003] Currently, heart valve replacement surgery can be performed, that is, a valve prosthesis is implanted into the diseased heart valve through an interventional and minimally invasive method to replace the original diseased heart valve of the patient. However, due to the large blood flow pressure between the atrium and the ventricle, the valve stent is prone to displacement. Summary of the Invention

[0004] The main technical problem to be solved by this application is to provide a valve stent and a prosthetic valve assembly that can make the anchoring connection between the valve stent and the heart tissue more stable.

[0005] To solve the above technical problem, a technical solution adopted by this application is: to provide a valve stent, which includes a valve stent body and at least two anchoring parts; the valve stent body includes a leaflet stent and a skirt stent that are connected to each other; the anchoring parts are connected to the valve stent body and are located outside the valve stent body, and the anchoring parts include a first anchoring member and a second anchoring member; wherein, axially, the orthographic projection of the first anchoring member on the valve stent body at least partially overlaps with the orthographic projection of the second anchoring member on the valve stent body; radially, the first anchoring member and the second anchoring member have a first state and a second state. In the first state, the first anchoring member in the overlapping area is closer to the valve stent body than the second anchoring member. In the second state, the first anchoring member in the overlapping area is farther from the valve stent body than the second anchoring member. The first state is the state before the valve stent is loaded on the valve delivery device, and the second state is the state when the valve stent is loaded on the valve delivery device.

[0006] Wherein, axially, the first anchoring member is located at one end away from the skirt stent, and the second anchoring member is located at one end close to the skirt stent.

[0007] Wherein, the first anchoring member is an extension of a rod at one end of the leaflet stent, the second anchoring member is an extension of a rod at the other end of the leaflet stent, the included angle between the first anchoring member and the one rod is an arc angle, and the one rod is farther from the skirt stent than the other rod.

[0008] Wherein, the first anchoring member and the second anchoring member are integrally formed with the valve stent body; or the first anchoring member and the second anchoring member are connected to the valve stent body by sewing, welding or riveting.

[0009] Wherein, the first anchoring member is arranged on one end rod of the leaflet stent, and the second anchoring member is arranged on the first anchoring member; or the second anchoring member is arranged on the other end rod of the leaflet stent, and the first anchoring member is arranged on the second anchoring member.

[0010] Wherein, the anchoring portion includes at least one auxiliary anchoring member, the auxiliary anchoring member includes at least one barb, the barb is arranged on the first anchoring member / second anchoring member, and the included angle between the barb and the first anchoring member body / second anchoring member body is 30°-60°.

[0011] Wherein, the anchoring portion includes at least one buffer member, and the buffer member is arranged at the end of the first anchoring member / second anchoring member.

[0012] Axially, the overlapping length of the first anchoring member and the second anchoring member in the overlapping area is 1-10 mm; radially, the distance between the anchoring portion and the valve stent body is 1-10 mm.

[0013] Wherein, the material of the anchoring portion includes a material with a shape memory effect.

[0014] Wherein, the skirt stent includes high-wave rounded corners and low-wave rounded corners, and the high-wave rounded corners and the low-wave rounded corners are woven at intervals to form the skirt stent.

[0015] Another technical solution adopted by the present application is: to provide a prosthetic valve assembly, which includes a prosthetic valve and the valve stent in the above technical solution that are connected to each other.

[0016] The beneficial effects of the present application are as follows: Different from the prior art, the present application provides a valve stent, which includes a valve stent main body and at least two anchoring parts; the valve stent main body includes a leaflet stent and a skirt stent that are connected to each other; the anchoring parts are connected to the valve stent main body and are located outside the valve stent main body, and the anchoring parts include a first anchoring member and a second anchoring member; wherein, axially, the orthographic projection of the first anchoring member on the valve stent main body at least partially coincides with the orthographic projection of the second anchoring member on the valve stent; by setting the partial coincidence of the first anchoring member and the second anchoring member, the first anchoring member and the second anchoring member can form a clamping of the native leaflet tissue, realizing the anchoring effect of the anchoring part on the native heart tissue. Radially, the first anchoring member and the second anchoring member have a first state and a second state. In the first state, the first anchoring member in the overlapping area is closer to the valve stent main body relative to the second anchoring member. In the second state, the first anchoring member in the overlapping area is farther from the valve stent main body relative to the second anchoring member. The first state is the state before the valve stent is loaded on the valve delivery device. After the delivery device transports the valve stent into the body and releases it, the second state can be maintained. After the delivery device transports the valve stent into the body and releases it, the second state is maintained. By setting the relative positions of the first anchoring member and the second anchoring member in the overlapping area, the relative positions of the first anchoring member and the second anchoring member in the overlapping area are changed, and the first anchoring member and the second anchoring member interact with each other to enhance the anchoring force of the anchoring part on the native heart tissue, making the anchoring connection between the valve stent and the heart tissue more stable. Description of the Drawings

[0017] Figure 1 is a front view structural schematic diagram of the valve stent in the embodiment of the present application;

[0018] Figure 2 is an axonometric structural schematic diagram of the valve stent in the embodiment of the present application;

[0019] Figure 3 is a partial structural schematic diagram of the valve stent in the embodiment of the present application;

[0020] Figure 4 is a partial structural schematic diagram of the second anchoring member in the embodiment of the present application;

[0021] Figure 5 is a simplified structural schematic diagram of the valve stent before being loaded on the delivery device in the embodiment of the present application;

[0022] Figure 6 is a simplified structural schematic diagram of the valve stent loaded on the delivery device in the embodiment of the present application;

[0023] Figure 7 is a simplified structural schematic diagram of the valve stent being released from the sheath tube in the embodiment of the present application;

[0024] Figure 8 It is a simplified structural schematic diagram of the valve stent after being released from the sheath tube in an embodiment of the present application;

[0025] Figure 9 It is a top-view structural schematic diagram of the valve stent in an embodiment of the present application;

[0026] Figure 10 It is a front-view structural schematic diagram of the leaflet stent in an embodiment of the present application;

[0027] Figure 11 It is an axonometric structural schematic diagram of the leaflet stent in an embodiment of the present application;

[0028] Figure 12 It is a partial structural schematic diagram of a first anchoring member in an embodiment of the present application;

[0029] Figure 13 It is a structural schematic diagram of another first anchoring member in an embodiment of the present application;

[0030] Figure 14 It is a simplified structural schematic diagram of another valve stent in an embodiment of the present application;

[0031] Figure 15 It is a structural schematic diagram of the barbs provided on the first anchoring member in an embodiment of the present application;

[0032] Figure 16 It is a simplified structural schematic diagram of the barbs provided on the second anchoring member in an embodiment of the present application;

[0033] Figure 17 It is a top-view structural schematic diagram of the skirt stent in an embodiment of the present application;

[0034] Figure 18 It is an axonometric structural schematic diagram of the skirt stent in an embodiment of the present application;

[0035] Figure 19 It is a schematic diagram of the implementation plane structure of the skirt stent in an embodiment of the present application;

[0036] Figure 20 It is a simplified structural schematic diagram of another valve stent in an embodiment of the present application;

[0037] Figure 21 It is a simplified structural schematic diagram of another valve stent in an embodiment of the present application. Detailed implementation manners

[0038] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present application without creative efforts shall fall within the protection scope of the present application.

[0039] 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 for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one such feature. In addition, the technical solutions between various embodiments can be combined with each other, but it must be based on the ability of those of ordinary skill in the art to implement. When the combination of technical solutions results in contradictions or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the protection scope required by the present application.

[0040] To make the purpose, technical solution and effect of the present application clearer and more definite, the following further describes the present application in detail with reference to the accompanying drawings and by way of examples.

[0041] The present application provides a valve stent, which includes a valve stent main body and at least two anchoring parts; the valve stent main body includes a leaflet stent and a skirt stent connected to each other; the anchoring parts are connected to the valve stent main body and are located outside the valve stent main body, and the anchoring parts include a first anchoring member and a second anchoring member; wherein, axially, the orthographic projection of the first anchoring member on the valve stent main body at least partially coincides with the orthographic projection of the second anchoring member on the valve stent. By setting the partial coincidence of the first anchoring member and the second anchoring member, the first anchoring member and the second anchoring member can form a clamping force on the native leaflet tissue, realizing the anchoring effect of the anchoring part on the heart tissue. Radially, the first anchoring member and the second anchoring member have a first state and a second state. In the first state, the first anchoring member in the overlapping area is closer to the valve stent main body relative to the second anchoring member. In the second state, the first anchoring member in the overlapping area is farther from the valve stent main body relative to the second anchoring member. The first state is the state before the valve stent is loaded on the valve delivery device, and the second state is the state when the valve stent is loaded on the valve delivery device. After the delivery device transports the valve stent to the body and releases it, it maintains the second state. By adjusting the relative positions of the first anchoring member and the second anchoring member in the overlapping area, the relative positions of the first anchoring member and the second anchoring member in the overlapping area are changed, so that the first anchoring member and the second anchoring member interact with each other to enhance the anchoring force of the anchoring part on the heart tissue, making the anchoring connection between the valve stent and the heart tissue more stable.

[0042] Please refer to Figures 1-2, Figure 1 It is a front view structural schematic diagram of the valve stent in the embodiment of the present application, Figure 2 and Figure 2 is an axonometric structural schematic diagram of the valve stent in the embodiment of the present application. The present application provides a valve stent 100. The valve stent 100 supports the prosthetic leaflets and can be regarded as a frame structure for supporting the prosthetic leaflets. During the contraction and dilation of the heart, it ensures that the normal operation of the prosthetic leaflets is not affected. The prosthetic leaflets supported by the valve stent 100 are relatively fixed to the heart tissue, so that the prosthetic leaflets can help repair and / or replace the function of the defective heart valve.

[0043] The valve stent 100 includes a valve stent main body 110. The valve stent main body 110 includes a leaflet stent 111 and a skirt stent 113 that are connected to each other. The leaflet stent 111 is used to position and install the prosthetic leaflets and can support the normal operation of the prosthetic leaflets; the setting of the skirt stent 113 can make the valve stent 100 fit better with the heart tissue and prevent paravalvular leakage. The valve stent 100 can be a mitral valve stent or a tricuspid valve stent, and no specific limitation is made here.

[0044] Optionally, the leaflet stent 111 and the skirt stent 113 can be integrally formed, or the leaflet stent 111 and the skirt stent 113 can be fixedly connected by one or more combinations of sewing, welding, riveting, etc.

[0045] Optionally, the leaflet stent 111 and the skirt stent 113 can be made by laser cutting one or more pipes. No specific limitation is made here. Preferably, they are shape memory metal pipes, such as nitinol alloy, etc. The valve stent 100 made of a shape memory metal pipe can automatically expand from a compressed state. That is to say, the valve stent 100 made of a shape memory metal pipe is more likely to automatically expand from a contracted or constrained structural state to an expanded or in-use structural state. In other embodiments, the leaflet stent 111 and the skirt stent 113 can also be made of wires, such as shape memory metal wires, etc., and can be specifically set according to the actual application scenario, and no specific limitation is made here.

[0046] Please refer to Figures 1-4 , Figure 3 which is a partial structural schematic diagram of the valve stent in the embodiment of the present application, Figure 4It is a partial structural schematic diagram of the second anchoring member in the embodiments of the present application. The valve stent 100 provided in the present application is provided with an anchoring portion 130. The anchoring portion 130 is connected to the valve stent main body 110 and is located outside the valve stent main body 110 for anchoring the valve stent main body 110 to the heart. Optionally, the valve stent 100 includes at least two anchoring portions 130. The two anchoring portions 130 are symmetrically arranged. The two anchoring portions 130 can be respectively located on both sides of the valve stent 100, so that the anchoring effect of the valve stent 100 on the native heart tissue is more stable. In other embodiments, the number of the anchoring portions 130 can also be 3, 4 or more, which can be set according to actual use needs and will not be specifically limited herein. The multiple anchoring portions 130 can be arranged at uniform intervals on the periphery of the valve stent 100.

[0047] The anchoring portion 130 includes a first anchoring member 131 and a second anchoring member 133. That is to say, the first anchoring member 131 and the second anchoring member 133 are arranged outside the valve stent main body 110, and the first anchoring member 131 and the second anchoring member 133 cooperate with each other to form the anchoring portion 130.

[0048] Among them, in the radial direction, there is a certain distance q between the first anchoring member 131 and the second anchoring member 133 and the valve stent main body 110, which can enable the normal operation of the prosthetic leaflet during the contraction and expansion of the heart to be unaffected or less affected, and the prosthetic leaflet can help repair and / or replace the function of the defective heart valve. Optionally, the distance q between the first anchoring member 131 and the second anchoring member 133 and the valve stent main body 110 is 1-10 mm, which can be specifically set according to actual use needs and will not be specifically limited herein.

[0049] Furthermore, viewed axially, the first anchoring member 131 is located at one end away from the skirt stent 113, and the second anchoring member 133 is located at one end close to the skirt stent 113. That is to say, viewed axially, the first anchoring member 131 is located above the second anchoring member 133. In other embodiments, axially, the first anchoring member 131 can also be located at one end close to the skirt stent 113, and the second anchoring member 133 can also be located at one end away from the skirt stent 113.

[0050] Please continue to refer to Figure 3 , axially, the orthographic projection of the first anchoring member 131 on the valve stent main body 110 and the orthographic projection of the second anchoring member 133 on the valve stent main body 110 at least partially overlap. That is to say, a partial area of the first anchoring member 131 and the second anchoring member 133 overlaps to form an overlapping portion 200. For example, the end of the first anchoring member 131 and the end of the second anchoring member 133 overlap.

[0051] Optionally, in the radial direction, the first anchoring member 131 and the second anchoring member 133 may be in close contact, with the end portions of the two anchoring members in the contact area overlapping to form an overlapping portion 200, such that their orthographic projections on the valve stent body 110 coincide. Alternatively, the first anchoring member 131 and the second anchoring member 133 may be spaced apart by a certain distance in the radial direction. By setting the partial overlap of the first anchoring member 131 and the second anchoring member 133, at the overlapping portion 200, the first anchoring member 131 and the second anchoring member 133 can interact to form a clamping force on the leaflet tissue, thereby realizing the anchoring effect of the anchoring portion 130 on the cardiac tissue.

[0052] Optionally, the overlapping length Q of the overlapping portion 200 of the first anchoring member 131 and the second anchoring member 133, or the overlapping length Q of the overlapping area of the orthographic projections of the first anchoring member 131 and the second anchoring member 133 on the valve stent body 110, can be specifically set according to actual usage requirements, and no specific limitation is made here. The size of the overlapping length Q can be designed considering the leaflet height distribution law of the replaced valve, the different physiological structures of the anterior and posterior leaflets, etc.; for example, the overlapping length Q is 1 - 10 mm. Within a certain range, the larger the overlapping length Q, the larger the contact area between the first anchoring member 131 and the second anchoring member 133 and the native leaflet tissue at the overlapping portion 200, the larger the clamping area formed by the interaction between the first anchoring member 131 and the second anchoring member 133 on the native leaflet tissue, and the correspondingly greater the clamping force on the native leaflet tissue, such that the anchoring force of the anchoring portion 130 on the native cardiac tissue is greater, enhancing the anchoring effect with the native cardiac tissue.

[0053] Among them, the length k of the second anchoring member 133 is 1 - 18 mm, and the width H is 1 - 6 mm, and no specific limitation is made here. In one embodiment, the width H of the second anchoring member 133 is greater than the width h of the first anchoring member 131, which is beneficial for the radially outward acting force generated by the second anchoring member 133 to act on the first anchoring member 131 to generate a stable anchoring force to anchor the native leaflet tissue.

[0054] Please refer to Figures 5-6 , Figure 5 which is a simplified structural schematic diagram of the valve stent before being loaded onto the delivery device in the embodiment of the present application, Figure 6 which is a simplified structural schematic diagram of the valve stent loaded onto the delivery device in the embodiment of the present application. In the radial direction, the relative positions of the first anchoring member 131 and the second anchoring member 133 at the overlapping portion 200 change, having a first state and a second state. As Figure 5 shown, when the valve stent is in the first state, viewed from the radial direction, at the overlapping portion 200, the first anchoring member 131 is closer to the leaflet stent 111 than the second anchoring member 133, that is, the first anchoring member 131 is located inside the second anchoring member 133; as Figure 6As shown, the valve stent is in the second state. Radially, at the overlapping portion 200, the second anchoring member 133 is closer to the leaflet stent 111 than the first anchoring member 131, that is, the second anchoring member 133 is located inside the first anchoring member 131. Figure 5 and Figure 6 The structures of the valve stent 100 shown are the structures of the same valve stent 100 in different states. That is to say, at the overlapping portion 200, the relative positions of the first anchoring member 131 and the second anchoring member 133 change. By adjusting the relative positions of the first anchoring member 131 and the second anchoring member 133 at the overlapping portion 200 during loading, when it is released into the heart, the first anchoring member 131 is released first, and then the anchoring member 133 is released, so that the relative positions of the first anchoring member 131 and the second anchoring member 133 change. There is an interference clamping structure between the first anchoring member 131 and the second anchoring member 133, so that the first anchoring member 131 and the second anchoring member 133 interact to form a clamping force, so as to enhance the anchoring force of the anchoring portion 130 on the heart tissue, making the anchoring connection between the valve stent 100 and the heart tissue more stable.

[0055] Specifically, assume Figure 5 the structure shown is the original structure of the valve stent 100, and its structure can be artificially adjusted to Figure 6 the structure shown. After being adjusted, affected by the stress, the first anchoring member 131 and the second anchoring member 133 tend to return to the original structural form. At this time, the second anchoring member 133 will generate a force towards the first anchoring member 131, that is, a radially outward force, and the first anchoring member 131 will generate a force towards the second anchoring member 133, that is, a radially inward force. At the overlapping portion 200, the two cooperate with each other to generate a clamping force, and the native leaflet tissue is clamped by using this clamping force to enhance the anchoring force of the valve stent 100 on the heart tissue.

[0056] Optionally, the first anchoring member 131 and the second anchoring member 133 can be made by laser cutting one or more shape memory metal tubes, such as nitinol alloy, etc., which are not specifically limited here. Due to the existence of the memory effect, the tendency of the first anchoring member 131 and the second anchoring member 133 to return to the original position is more obvious, which can increase the recovery stress, and thus increase the clamping force, thereby enhancing the anchoring force of the valve stent 100 on the heart tissue.

[0057] Optionally, it can be to adjust the relative positions of the first anchoring member 131 and the second anchoring member 133 when implanting the valve stent 100. After implantation, the first anchoring member 131 and the second anchoring member 133 tend to return to the original position, thereby forming a clamping force to clamp the leaflet tissue, which actually plays a role in fixing the valve stent 100.

[0058] Please refer to Figures 7-8 ,Figure 7 It is a simplified structural schematic diagram when the valve stent is released from the sheath tube in the embodiment of the present application. Figure 8 It is a simplified structural schematic diagram after the valve stent is released from the sheath tube in the embodiment of the present application. In this embodiment, before being inserted into the sheath tube 300, at the overlapping part 200 of the valve stent 100, the first anchoring member 131 is closer to the valve stent main body 110 than the second anchoring member 133, that is, the first anchoring member 131 is located inside the second anchoring member 133; when inserting the valve stent 100 into the sheath tube 300, the relative positions of the first anchoring member 131 and the second anchoring member 133 are adjusted, so that the relative positions of the first anchoring member 131 and the second anchoring member 133 at the overlapping part 200 are changed, and the second anchoring member 133 is closer to the valve stent main body 110 than the first anchoring member 131, that is, the second anchoring member 133 is located inside the first anchoring member 131. As Figure 7 shown, after the valve stent 100 is transported to near the native heart tissue, the first anchoring member 131 is located on the outside, and the first anchoring member 131 will be released first, and then the second anchoring member 133 will be released; as Figure 8 shown, after release, the second anchoring member 133 at the overlapping part 200 is located inside the first anchoring member 131. At this time, the second anchoring member 133 will generate a force towards the first anchoring member 131, that is, a radially outward force, which cooperates with the first anchoring member 131 to generate a clamping force to clamp the leaflet tissue and enhance the anchoring force of the valve stent 100 on the heart tissue.

[0059] Please refer to Figures 9-11 , Figure 9 It is a top view structural schematic diagram of the valve stent in the embodiment of the present application. Figure 10 It is a front view structural schematic diagram of the leaflet stent in the embodiment of the present application. Figure 11 It is an axonometric structural schematic diagram of the leaflet stent in the embodiment of the present application. The valve stent main body 110 includes a leaflet stent 111 and a skirt stent 113 that are connected to each other. The valve stent main body 110 is opened to extend the leaflet stent 111, and the valve stent main body 110 is closed to contract the leaflet stent 111. As Figure 9 shown, the leaflet stent 111 is generally cylindrical, and the diameter of the cylinder is between 28 and 35 millimeters, which is not specifically limited here.

[0060] Among them, a prosthetic leaflet is arranged inside the leaflet stent 111, and the prosthetic leaflet is movable when blood flows. The leaflet stent 111 is provided with installation positioning holes for positioning and installing the prosthetic leaflet, so that the prosthetic leaflet is connected to the leaflet stent 111, so that the valve stent main body 110 plays a supporting role for the prosthetic leaflet.

[0061] Please continue to refer to Figures 10-11, the first anchoring member 131 is an extension of one end member of the leaflet support 111, and the second anchoring member 133 is an extension of the other end member of the leaflet support 111. Among them, one end member of the leaflet support 111 can be defined as the upper end member 1111 of the leaflet support 111, and the other end member of the leaflet support 111 can be defined as the lower end member 1113 of the leaflet support 111. Specifically, the leaflet support 111 includes an upper end member 1111 and a lower end member 1113, and the upper end member 1111 is closer to the skirt support 113 than the lower end member 1113.

[0062] In an embodiment, the first anchoring member 131 is an extension of the lower end member 1113 of the leaflet support 111, and the second anchoring member 133 is an extension of the upper end member 1111 of the leaflet support 111. The lower end member 1113 extends axially upward to form the first anchoring member 131, and the upper end member 1111 extends axially downward to form the second anchoring member 133.

[0063] Please continue to refer to Figure 10 , the second anchoring member 133 includes a first extension 1331 and a second extension 1333. The first extension 1331 and the second extension 1333 can be integrally formed or connected by welding or other means.

[0064] Among them, the included angle between the first extension 1331 and the upper end member 1111 of the leaflet support 111 in the axial direction is α, and the second extension 1333 is parallel to the axial direction of the upper end member 1111 of the leaflet support 111. Within a certain range, the larger the included angle α, after adjusting the relative positions of the first anchoring member 131 and the second anchoring member 133 at the overlapping portion 200, the larger the change angle generated by the second anchoring member 133, so that the force generated by the second anchoring member 133 towards the first anchoring member 131 is larger, that is, the radially outward force is larger, and a greater clamping force is formed in cooperation with the first anchoring member 131, thereby making the anchoring effect of the valve support 100 on the native heart tissue more stable. The included angle α can be specifically set according to actual use needs, for example, it is 30° - 60°, and no specific limitation is made here.

[0065] Optionally, the first anchoring member 131 and the second anchoring member 133 are integrally formed with the valve support body 110, or the first anchoring member 131 and the second anchoring member 133 can be connected and fixed to the valve support body 110 by any one or a combination of sewing, welding or riveting.

[0066] Please refer to Figure 12 , Figure 12It is a partial structural schematic diagram of a first anchoring member in an embodiment of the present application. In this embodiment, the first anchoring member 131 is integrally manufactured with the leaflet stent 111. In this embodiment, the included angle f between the first anchoring member 131 and the lower rod member 1113 of the leaflet stent 111 is an arc angle.

[0067] Please refer to Figure 13 , Figure 13 It is a structural schematic diagram of another first anchoring member in an embodiment of the present application. In this embodiment, the first anchoring member 131 is separately manufactured from the leaflet stent 111. At this time, the first anchoring member 131 and the lower rod member 1113 of the leaflet stent 111 can be connected by sewing, welding or riveting, etc. The connection bonding force is better, and there is no limit to its connection angle, which can be an arc angle or an acute angle, etc. By separately manufacturing the first anchoring member 131 and the leaflet stent 111, it is easy to be manufactured and formed, and at the same time, the strength of the connection part is enhanced.

[0068] Further, installation positioning holes are provided on the first anchoring member 131 and the lower rod member 1113 of the leaflet stent 111, and the first anchoring member 131 is positioned and installed on the leaflet stent 111 by using the installation positioning holes.

[0069] In one embodiment, the first anchoring member 131 and the second anchoring member 133 can be connected to form an anchoring part 130, and then the anchoring part 130 is connected to the leaflet stent 111. For example, the first anchoring member 131 is arranged on the second anchoring member 133, and the second anchoring member 133 is arranged on the upper rod member 1111 of the leaflet stent 111; or the second anchoring member 133 is arranged on the first anchoring member 131, and the first anchoring member 131 is arranged on the lower rod member 1113 of the leaflet stent 111.

[0070] Please refer to Figure 14 , Figure 14 It is a simplified structural schematic diagram of another valve stent in an embodiment of the present application. In this embodiment, the second anchoring member 133 is arranged on the upper rod member 1111 of the leaflet stent 111, and the first anchoring member 131 is arranged on the second anchoring member 133.

[0071] Further, installation positioning holes are provided on the first anchoring member 131 and the second anchoring member 133, and the first anchoring member 131 and the second anchoring member 133 are connected by sewing, riveting, welding, etc. to form the anchoring part 130. The anchoring part 130 and the leaflet stent 111 can be connected and fixed by sewing, riveting, welding, etc.

[0072] Please continue to refer to Figure 14, the anchoring portion 130 further includes at least one buffer member 135, and the buffer member 135 can reduce the damage of the valve stent 100 to the native leaflet tissue and other fibrous tissues around it. Optionally, the buffer member 135 can be provided at the end of the first anchoring member 131 or the second anchoring member 133, and no specific limitation is made here.

[0073] Among them, the buffer member 135 is spherical and is made of a polymer material with good biocompatibility. For example, polytetrafluoroethylene (PTFE, Poly Tetra Fluoroethylene), etc., and no specific limitation is made here.

[0074] Please refer to Figures 15-16 , Figure 15 is a schematic structural diagram of barbs provided on the first anchoring member in the embodiment of the present application, Figure 16 is a simplified structural diagram of barbs provided on the second anchoring member in the embodiment of the present application. The anchoring portion 130 further includes at least one auxiliary anchoring member, and the auxiliary anchoring member includes at least one barb 137. The barb 137 pierces into the leaflet tissue to enhance the anchoring effect between the valve stent 100 and the heart tissue. Optionally, the barb 137 is provided on the first anchoring member 131 or the second anchoring member 133. When the barb 137 is provided on the first anchoring member 131, there is a certain distance from the chordae tendineae, or it is provided on both the first anchoring member 131 and the second anchoring member 133 at the same time. In other embodiments, barbs may not be provided on the first anchoring member 131 and the second anchoring member 133, and no specific limitation is made here.

[0075] Among them, the number of barbs 137 is 1, 2, 3, etc., and no specific limitation is made here.

[0076] As Figure 15 shown, the length b of the barb 137 is 1 - 3 mm, the width c of the barb 137 is 0.3 - 1 mm, and the angle β formed by the barb 137 and the first anchoring member 131 is 30° - 60°. The length b, width c of the barb 137 and the angle β formed with the first anchoring member 131 can be specifically set according to actual use needs, and no specific limitation is made here. Within a certain range, the larger the length b, width c of the barb 137 and the angle β formed with the first anchoring member 131, the greater the anchoring force of the anchoring portion 130 on the heart tissue, ensuring that the relative position of the valve stent 100 and the heart tissue remains unchanged, thereby assisting in enhancing the anchoring effect of the valve stent 100 on the heart tissue. In other embodiments, the included angle between the barb 137 and the second anchoring member 133 can also be 30° - 60°, etc., and no specific limitation is made here.

[0077] Further, the barbs 137 can extend radially inward or radially outward; specifically depending on whether the barbs 137 are provided on the first anchor 131 or the second anchor 133, with the criterion being that the barbs 137 penetrate the leaflet tissue after implantation into the heart to form an anchoring force.

[0078] Please refer to Figure 8 and Figure 15 , where the barbs 137 are provided on the first anchor 131, the barbs 137 extend radially inward, penetrate the leaflet tissue, and press against the second anchor 133, that is, the second anchor 133 abuts against the barbs 137 to prevent the barbs 137 from continuing to penetrate inward and damaging the myocardial tissue; moreover, the barbs 137 exert a radially inward acting force on the second anchor 133, increasing the acting force of the second anchor 133 towards the first anchor 131, increasing the clamping force generated by the cooperation with the first anchor 131 on the leaflet tissue, that is, increasing the anchoring acting force of the anchoring portion 130 on the heart tissue, thereby assisting in enhancing the anchoring effect of the valve stent 100 on the heart tissue, ensuring that the relative position of the valve stent 100 and the heart tissue remains unchanged, and improving the fit degree of the valve stent 100 and the heart tissue.

[0079] Please refer to Figures 17-19 , Figure 17 which is a top view structural schematic diagram of the skirt stent in the embodiment of the present application, Figure 18 which is an axonometric structural schematic diagram of the skirt stent in the embodiment of the present application, Figure 19 which is an implementation plane structural schematic diagram of the skirt stent in the embodiment of the present application. The valve stent main body 110 includes a skirt stent 113. As Figure 17 shown, the skirt stent 113 can generally be in a flower shape as a whole, and the skirt stent 113 can be regarded as being composed of multiple petal-shaped structures, and the petal-shaped structures can be called skirt structures, that is, the skirt stent 113 includes multiple skirt structures.

[0080] Among them, the skirt structure is connected to the main frame portion of the skirt stent 113 through a transition rod, and the skirt structure between two adjacent transition rods can have various fold shapes. For example, the skirt structure can be in a W shape. In order to better fit the heart myocardial tissue and not increase the resistance of the valve stent 100 entering the sheath tube, the fold shape of the skirt structure can be specifically set according to actual applications, and no specific limitation is made here.

[0081] Optionally, the skirt stent 113 can be woven and formed by a braided wire with a memory effect, which can better adapt to the physiological structure of the mitral valve or tricuspid valve, is more likely to form a D shape or an anatomically adapted structure, more closely matches the true mitral valve anatomical structure, reduces the compression on the aorta, and prevents paravalvular leakage.

[0082] Specifically, as Figure 17 , 18As shown, the skirt support 113 includes a high-wave rounded corner 1131 and a low-wave rounded corner 1133. The high-wave rounded corner 1131 and the low-wave rounded corner 1133 are woven at intervals to form the skirt support 113. In other ways, other weaving methods can also be used to form the skirt support 113, which is not specifically limited herein.

[0083] Further, as Figure 19 shown, the skirt support 113 further includes a first connection end 1135 and a second connection end 1137. When the skirt support 113 is formed by a weaving method, the skirt support 113 cannot be integrally formed with the leaflet support 111 and needs to be manufactured separately. The leaflet support 111 and the skirt support 113 are fixedly connected by one or a combination of sewing, welding, riveting, etc. At this time, the first connection end 1135 is fixedly connected to the leaflet support 111; the second connection end 1137, which is a larger deformation end, contacts the myocardial tissue around the mitral valve annulus tissue. There will be a large deformation during the cardiac cycle of the heart, but the generated force is small, which plays a certain protective role for the leaflet support 111, can reduce the compression on the leaflet support 111 when the prosthetic leaflet closes, and can also reduce the damage of the skirt support 113 to the myocardial tissue and prevent paravalvular leakage.

[0084] Please refer to Figures 20-21 , Figure 20 which is a simplified structural schematic diagram of another valve support in the embodiment of the present application, Figure 21 which is a simplified structural schematic diagram of another valve support in the embodiment of the present application. Figure 20 The skirt support 113 shown is not woven, Figure 21 The skirt support 113 shown is formed by weaving the high-wave rounded corner 1131 and the low-wave rounded corner 1133 at intervals. Compared with Figure 20 the ordinary skirt support 113 that is not formed by weaving shown, since the woven skirt support 113 has the high-wave rounded corner 1131 and the low-wave rounded corner 1133, the skirt support 113 contacts the second anchor 133 and the mitral valve annulus, making the skirt support 113 fit better with the heart tissue, allowing the annulus tissue to obtain a greater radial change during the cardiac cycle of the heart tissue and preventing paravalvular leakage.

[0085] The present application also provides a prosthetic valve assembly. The prosthetic valve assembly includes a prosthetic valve and the valve support 100 in the above embodiment that are connected to each other.

[0086] Optionally, the prosthetic valve is a prosthetic leaflet, which is a thin layer of material, usually prepared from homologous or heterologous biological materials, such as porcine pericardium, bovine pericardium, etc., and can also be prepared from artificial ultra-high molecular weight polyethylene, nylon mixture or polymer materials, so that the prepared prosthetic leaflet is durable and not affected by stretching deformation or fatigue.

[0087] Optionally, the number of prosthetic leaflets can be one, two, or multiple, etc., without specific limitation herein. When the number of prosthetic leaflets is even, the prosthetic leaflets are symmetrically distributed about the center in the circumferential direction along the inner surface of the leaflet stent 111. When the number of prosthetic leaflets is odd, the prosthetic leaflets are evenly arranged at equal intervals along the inner surface of the leaflet stent 111, and two adjacent prosthetic leaflets are joined together at one end close to the leaflet stent 111 to form a leaflet angle.

[0088] Specifically, when the cardiac tissue starts the contraction cycle, according to the direction of blood flow, the prosthetic leaflets move in the same direction. Without damaging the prosthetic leaflets, the prosthetic leaflets form an opening as large as possible within the leaflet stent 111 to allow blood to flow from one chamber of the heart to another chamber or to flow outside the heart. After the contraction cycle of the cardiac tissue ends, the blood will immediately flow in the reverse direction, pushing the leaflets from the opposite direction to close the prosthetic leaflets and preventing retrograde blood flow through or preventing blood reflux. That is to say, the prosthetic leaflets play the role of a one-way valve in the leaflet stent 111, only allowing blood to move in one-way direction (for example, from the left atrium to the left ventricle direction), and blocking the backflow or reflux of blood.

[0089] The valve stent 100 supports the prosthetic leaflets and can be regarded as a frame structure for supporting the prosthetic leaflets. By anchoring and connecting the valve stent 100 to the annulus region, the prosthetic leaflets supported by the valve stent 100 are relatively fixed to the cardiac tissue and fit more closely to the cardiac tissue, so that the prosthetic leaflets can help repair and / or replace the function of the defective heart valve.

[0090] Different from the prior art, the present application provides a valve stent and a prosthetic valve assembly. The valve stent includes a valve stent body and at least two anchoring portions; the valve stent body includes a leaflet stent and a skirt stent that are connected to each other; the anchoring portions are connected to the valve stent body and are located outside the valve stent body, and the anchoring portions include a first anchoring member and a second anchoring member; wherein, axially, the orthographic projection of the first anchoring member on the valve stent body at least partially coincides with the orthographic projection of the second anchoring member on the valve stent. By setting the partial coincidence of the first anchoring member and the second anchoring member, the first anchoring member and the second anchoring member can form a clamping of the native leaflet, realizing the anchoring effect of the anchoring portion on the native heart tissue. Radially, the first anchoring member and the second anchoring member have a first state and a second state. In the first state, the first anchoring member in the overlapping region is closer to the valve stent body relative to the second anchoring member. In the second state, the first anchoring member in the overlapping region is farther from the valve stent body relative to the second anchoring member. The first state is the state before the valve stent is loaded on the valve delivery device, and the second state is the state when the valve stent is loaded on the valve delivery device. After the delivery device transports the valve stent to the body and releases it, the second state can be maintained. By adjusting the relative position of the first anchoring member and the second anchoring member in the overlapping region, the relative position of the first anchoring member and the second anchoring member in the overlapping region is changed, so that the second anchoring member will generate a radially outward force, which cooperates with the first anchoring member to generate a clamping force to clamp the leaflet tissue, so as to enhance the anchoring force of the anchoring portion on the heart tissue; by providing at least two anchoring portions, the two anchoring portions can be symmetrically arranged, making the anchoring effect of the valve stent on the heart tissue more stable, ensuring that the valve stent does not undergo relative displacement relative to the heart tissue, improving the fitting degree of the valve stent and the heart tissue, and preventing paravalvular leakage.

[0091] The above are only the embodiments of the present application, and do not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made by using the content of the specification and drawings of the present application, or directly or indirectly applied in other related technical fields, shall be included in the patent protection scope of the present application by the same token.

Claims

1. A valve stent, characterized in that, The valve stent includes: A valve stent body, which includes a leaflet stent and a skirt stent connected to each other; At least two anchoring parts, connected to the valve stent body and located outside the valve stent body, and the anchoring parts include a first anchoring member and a second anchoring member; Wherein, axially, the orthographic projection of the first anchoring member on the valve stent body at least partially coincides with the orthographic projection of the second anchoring member on the valve stent body; radially, the first anchoring member and the second anchoring member have a first state and a second state. In the first state, the first anchoring member in the overlapping area is closer to the valve stent body than the second anchoring member. In the second state, the first anchoring member in the overlapping area is farther from the valve stent body than the second anchoring member, and the first anchoring member and the second anchoring member have a tendency to return to the first state. The first state is the state before the valve stent is loaded on the valve delivery device, and the second state is the state when the valve stent is loaded on the valve delivery device.

2. The valve stent according to claim 1, wherein Axially, the first anchoring member is located at one end away from the skirt stent, and the second anchoring member is located at one end close to the skirt stent.

3. The valve stent according to claim 1, wherein The first anchoring member is an extension of a rod at one end of the leaflet stent, the second anchoring member is an extension of a rod at the other end of the leaflet stent, the included angle between the first anchoring member and the one rod is an arc angle, and the one rod is farther from the skirt stent than the other rod.

4. The valve stent according to claim 1, wherein The first anchoring member and the second anchoring member are integrally formed with the valve stent body; or The first anchoring member and the second anchoring member are connected to the valve stent body by sewing, welding or riveting.

5. The valve stent according to claim 1, wherein The first anchoring member is arranged on a rod at one end of the leaflet stent, and the second anchoring member is arranged on the first anchoring member; or The second anchoring member is arranged on a rod at the other end of the leaflet stent, and the first anchoring member is arranged on the second anchoring member; The one rod is farther from the skirt stent than the other rod.

6. The valve stent according to any one of claims 1-5, wherein The anchoring part includes at least one auxiliary anchoring member, and the auxiliary anchoring member includes at least one barb. The barb is arranged on the first anchoring member / the second anchoring member, and the included angle between the barb and the main body of the first anchoring member / the second anchoring member is 30° to 60°.

7. The valve stent according to claim 6, wherein The anchoring part includes at least one buffer member, and the buffer member is arranged at the end of the first anchoring member / the second anchoring member.

8. The valve stent according to claim 6, wherein Axially, the overlapping length of the first anchoring member and the second anchoring member in the overlapping region is 1-10 mm; radially, the distance between the anchoring portion and the valve stent body is 1-10 mm.

9. The valve stent according to any one of claims 1-5, characterized in that the material of the anchoring portion includes a material with shape memory effect.

10. The valve stent according to any one of claims 1-5, characterized in that the skirt stent includes high-wave rounded corners and low-wave rounded corners, and the high-wave rounded corners and the low-wave rounded corners are woven at intervals to form the skirt stent.

11. A prosthetic valve assembly, characterized in that the prosthetic valve assembly includes a prosthetic valve and a valve stent according to any one of claims 1-10 connected to each other.

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