WO2022053083A1

WO2022053083A1 - Bi-leaflet valve prosthesis having valve flaps

Info

Publication number: WO2022053083A1
Application number: PCT/CN2021/129981
Authority: WO
Inventors: 钟生平; 靳永富
Original assignee: 金仕生物科技（常熟）有限公司
Priority date: 2020-09-14
Filing date: 2021-11-11
Publication date: 2022-03-17
Also published as: CN111991119B; CN111991119A

Abstract

The present application relates to a bi-leaflet valve prosthesis having valve flaps (3), comprising a valve frame (1), a valve skirt (2), two valve leaflets (3), and two valve flaps (3). The two valve leaflets (2) are arranged inside the valve frame (1) and are connected to the valve skirt. The two valve flaps (3) are arranged inside the valve frame (1), and the valve flaps (3) project from the inner wall of the valve frame toward the inside of the valve frame. When the present valve prosthesis is in the closed state, apposition between the two valve leaflets (2) and apposition respectively between the two valve leaflets (2) and the two valve flaps (3) block a passage of the valve prosthesis, so as to effectively seal the passage. In the open state, the two valve leaflets (2) are separated from each other in a direction toward the valve frame (1), so as to enable the passage to be sufficiently opened. During the periodic opening and closing of the valve, the valve flaps (3) do not participate in the opening and closing actions as the valve leaflets (2) do. The matching design of the valve leaflets (2) and the valve flaps (3) allows for the length of the free edge of valve leaflets (2) required for the open and close states to be consistent, such that the valve leaflets (2) may be fully stretched when being opened and closed, and meanwhile, good opening and closing effects may be achieved when the valve is largely deformed.

Description

Bicuspid valve prosthesis with flap ears

technical field

The present application relates to the technical field of medical devices, and in particular, to a bicuspid valve prosthesis with valve ears.

Background technique

During the systolic and diastolic phases of the heart, the orifice of the heart valve will present a non-circular shape, and the ratio of its major diameter to its minor diameter will change within a certain range. The shape of the mitral valve annulus is naturally non-circular, and the ratio of long and short diameters further increases during systole. When the traditional tri-leaflet valve prosthesis has a non-circular orifice, when the ratio of length to diameter varies within a certain range, the leaflets of the valve can still maintain a certain coaptation when the valve is closed, and no regurgitation occurs. However, when the ratio changes greatly, the valve leaflet will become abnormal due to excessive deformation of the valve frame, resulting in regurgitation.

Especially for the interventional mitral valve, due to the large elasticity and low rigidity of the valve frame, the length-to-diameter ratio of the valve frame changes greatly, and the tricuspid valve cannot adapt to this change and causes severe regurgitation.

Application content

The present application relates to a bicuspid valve prosthesis with valve ears to solve the problem of regurgitation when the tricuspid valve prosthesis is closed in a non-circular state.

The purpose of this application is to provide a bicuspid valve prosthesis with valve ears, which includes:

A valve frame, wherein the valve frame is fixedly provided with a valve skirt;

Two valve leaflets are arranged in the valve frame and are connected with the valve skirt;

Two flap ears are arranged in the flap holder, and the flap ear is protruded from the inner wall of the flap holder to the interior of the flap holder;

Wherein, the bi-leaflet valve prosthesis with valve ears has an open state and a closed state, and in the closed state, between the two valve leaflets and the two valve leaflets are respectively connected with the two valve ears The passage of the bi-leaflet valve prosthesis is blocked after the abutment between them. In the open state, the two valve leaflets are separated from each other in the direction of approaching the valve frame, so as to open the passage.

In a possible implementation manner, after the edges on both sides of the valve ear are connected to the positions on the valve frame on both sides of the abutment interface of the two valve leaflets, the valve ear is away from the One end of the valve holder is formed with a bent portion.

In a possible implementation manner, in the open state, the ratio between the length occupied by the valve ear in the circumferential direction of the valve holder and the length of the valve leaflet in the circumferential direction of the valve holder is in the range of 0.1 to 0.6.

In a possible implementation manner, the cross section of the valve holder is a non-circular structure, and has a long diameter and a short diameter, and the ratio of the long diameter to the short diameter is 1.05-1.50.

In a possible implementation manner, the cross section of the valve holder is a D-shaped or elliptical structure;

The cross section of the valve holder has a long diameter and a short diameter, the two valve leaflets are respectively arranged on both sides of the long diameter, and the two valve ears are respectively arranged on both ends of the long diameter.

In a possible implementation manner, the valve leaflet has a first free end, the valve ear has a second free end, the second free end is flush with the first free end, or the second free end The free end protrudes from the first free end.

In a possible implementation manner, the thickness of the leaflet is 0.25mm˜0.65mm.

The technical solution provided by this application can achieve the following beneficial effects:

In the bi-leaflet valve prosthesis with valve ears provided in this application, the valve frame can make the two valve leaflets and the valve leaflets and the valve ears meet each other through the pushing action of blood in the flow during the systolic and diastolic process of the heart. Close the passage of the valve prosthesis, or drive the two valve leaflets and the valve leaflets and the valve ear to separate from each other to open the passage; wherein, when the valve prosthesis is in the closed state, the two valve leaflets can be maintained by the pushing force of the blood. In the closed state, at the same time, the length of the free edge of the valve leaflet required in the open and closed state is consistent through the matching design of the valve leaflet and the valve ear, thereby improving the closing performance of the valve prosthesis and preventing blood leakage.

Through the cooperative design of the valve leaflet and the valve ear, in the case of a large deformation of the valve, a good opening and closing effect can also be achieved.

It is to be understood that the foregoing general description and the following detailed description are exemplary only and do not limit the application.

Description of drawings

1 is a schematic structural diagram of a bicuspid valve prosthesis with valve ears provided in an embodiment of the present application;

2 is a state diagram of the bicuspid valve prosthesis with valve ears provided in an embodiment of the application in an open state;

3 is a state diagram of the bicuspid valve prosthesis with valve ears provided in an embodiment of the present application in a closed state;

FIG. 4 is a state diagram of the valve ear set in the valve holder.

Reference number:

1-flap holder;

11-import;

12-Export;

2 - leaflets;

21 - the first free end;

3-lobed ear;

31 - void;

32-bending part;

33 - Second free end.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the application and together with the description serve to explain the principles of the application.

detailed description

In order to make the purpose, technical solutions and advantages of the present application more clearly understood, the present application will be described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application, but not to limit the present application.

In the description of this application, unless otherwise clearly specified and limited, the terms "first" and "second" are only used for the purpose of description, and should not be construed as indicating or implying relative importance; unless otherwise specified or explained , the term "multiple" refers to two or more; the terms "connection" and "fixed" should be understood in a broad sense, for example, "connection" can be a fixed connection, a detachable connection, or an integral Connection, or electrical connection; either directly or indirectly through an intermediary. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific situations.

In the description of this specification, it should be understood that the directional words such as "upper" and "lower" described in the embodiments of the present application are described from the perspective shown in the accompanying drawings, and should not be construed as referring to the embodiments of the present application. limited. Also, in this context, it should also be understood that when an element is referred to as being "on" or "under" another element, it can not only be directly connected "on" or "under" the other element, but also Indirectly connected "on" or "under" another element through intervening elements.

As shown in FIGS. 1 to 4 , the embodiments of the present application provide a bi-leaflet valve prosthesis with valve ears, which includes a valve frame 1, a valve skirt, two valve leaflets 2 and two valve ears 3; wherein , the valve skirt is fixedly arranged in the interior of the valve frame 1, and specifically can be fixed and covered on the inner wall of the valve frame 1, two valve leaflets 2 are arranged in the valve frame 1, and are connected with the valve skirt; two valve ears 3 are arranged on the valve frame 1 In the frame 1, and the valve ear 3 protrudes from the inner wall of the valve frame 1 to the interior of the valve frame 1; wherein, the bicuspid valve prosthesis with the valve ear has an open state and a closed state, and in the closed state, the two flaps Between the leaflets 2 and between the two leaflets 2 and the two valve ears 3 respectively, the passage of the bi-leaflet valve prosthesis is blocked, and in the open state, the two leaflets 2 can move toward the direction close to the valve frame 1 separated from each other to open access.

Among them, the valve holder 1 has an inlet 11 and an outlet 12. When the blood is flowing forward, it can enter from the inlet 11, and under the action of the blood flow, the valve leaflet 2 is opened, that is, the passage between the inlet 11 and the outlet 12 is opened, The blood can be discharged from the outlet 12, at this time, the valve prosthesis is in an open state; when the blood flows in the reverse direction, the valve leaflet 2 cooperates with the valve ear 3 to close the valve prosthesis, that is, the passage between the inlet 11 and the outlet 12 Closing, preventing blood from passing through the valve leaflets 2, at this time, the valve prosthesis is in a closed state.

The valve leaflet 2 is made of flexible material, and the edge of one end of the valve leaflet 2 away from the valve skirt forms a free edge, and the free edge can close or open the passage of the valve prosthesis after being pushed by the blood. As shown in Figure 2, when the valve prosthesis is in the open state, the valve leaflet 2 can be close to the side wall of the valve frame 1 after deployment, and the passage of the valve prosthesis is opened after the two valve leaflets 2 are separated from each other; As shown in Fig. 3, when the valve prosthesis is in a closed state, the passage of the valve prosthesis can be closed after the two valve leaflets 2 are abutted at the position between the two valve ears 3. Wherein, the two valve ears 3 can be symmetrically arranged at both ends of the long diameter of the valve prosthesis, the valve leaflets 2 can be connected with the valve skirt at the positions on both sides of the valve ears 3, and in the closed state, the valve leaflets 2 can be connected with the valve The abutment of the ears 3 can make the valve leaflet 2 fully expand in the closed state, so that the length of the free side of the valve leaflet 2 in the open and closed states is consistent, thereby effectively improving the sealing effect of the valve prosthesis, avoiding the need for the problem of blood return.

Among them, it should be emphasized that, by setting the valve ear 3, the valve leaflet 2 can be sewn on the valve skirt at the positions on both sides of the valve ear 3, without making the valve leaflet 2 sewn on the valve skirt and aligned with the long diameter Therefore, the length of the valve leaflet 2 is reduced, so that the valve leaflet 2 can be fully unfolded in the open or closed state, and the effective alignment between the two valve leaflets 2 and between the valve leaflet 2 and the valve ear 3 is ensured. It can improve the closing effect of the passage.

In addition, it should be noted that when the traditional tri-leaflet valve has a non-circular orifice, when the ratio of length to diameter varies within a certain range, the leaflets of the valve can still maintain a certain coaptation when the valve is closed, and no regurgitation occurs. However, when the ratio changes greatly, the valve leaflet will become abnormal due to excessive deformation of the valve frame, resulting in regurgitation. Especially for interventional valves, due to the large elasticity and low rigidity of the valve frame, the length-to-diameter ratio of the valve frame also changes greatly, and the tri-leaflet valve cannot adapt to this change, causing severe regurgitation.

In order to solve this technical problem, one way in the prior art is to increase the stiffness of the stent to resist deformation. However, the tricuspid valve prosthesis may squeeze the aortic valve and make the aorta abnormal.

Another way is to solve the problem of regurgitation caused by the deformation of the tri-leaflet valve prosthesis by setting a double-layer stent. Its structure is: the inner stent with a circular cross-section is connected with the outer stent, and three leaflets are fixed to the inner stent. At the same time, the diameter of the outer stent is larger than that of the inner stent, so that the outer stent can follow the The heart is deformed by contraction and relaxation, and the deformation of the outer stent will not affect the inner stent during the deformation process, so that the cross section of the inner stent is always circular, ensuring that the trileaflet valve prosthesis has good closing performance. However, in this structure, due to the need to have a sufficient diameter difference between the inner and outer layers of the stent, when the trileaflet valve prosthesis is loaded into the delivery system, the volume of the delivery system will increase, which will lead to the increase of the volume of the trileaflet valve valve. Implantation of prostheses is difficult and risky when implanted into the human body.

For this reason, the bicuspid valve prosthesis with valve ears provided by the present application, by setting two valve leaflets 2 and two valve ears 3, makes the valve frame 1 in the process of systole and diastole of the heart, and through the flow of blood The pushing action can push the two valve leaflets 2 to match each other and the valve leaflets 2 and the valve ear 3 to match each other, so as to close the passage of the valve prosthesis, or drive the two valve leaflets 2 to separate from each other and the valve leaflets 2 and the valve ear 3 are separated from each other to open access. Wherein, when the valve prosthesis is in the closed state, the pushing force of blood can maintain the closed state between the two valve leaflets 2 and between the valve leaflets 2 and the valve ear 3, thereby improving the closure of the valve prosthesis performance, preventing blood leakage; that is, the two valve leaflets 2 and valve ears 3 in this application can achieve effective closure under any degree of deformation of the valve holder 1 to prevent blood backflow. In addition, compared with the structure in which the double-layer stent is provided in the prior art, the single-layer valve stent 1 in this embodiment is convenient for implantation into the human body, and at the same time, the effective opening area of the valve prosthesis can be increased.

In a specific implementation, as shown in FIGS. 2 and 4 , after the edges on both sides of the flap ear 3 are connected to the positions on the flap frame 1 on both sides of the abutment interface of the two flap leaflets 2, the flap ear 3. A bent portion 32 is formed at one end away from the valve holder 1.

Wherein, as shown in FIG. 4 , the bending portion 32 can be an edge formed on the flap ear 3, the flap ear 3 is a flexible structure, and after the flap ear 3 is bent at a certain angle at the position of the bending portion 32, the flap ear 3 Both sides of 3 can be fixedly connected with the flap skirt, so that the two flap ears 3 are gathered from one side of the flap skirt to the bending portion 32 away from the flap skirt. Wherein, the valve ear 3 occupies a certain connection length on the valve holder 1, and the bent portion 32 at the end of the valve ear 3 away from the valve holder 1 can be formed on the long diameter of the valve prosthesis. When the valve leaflet 2 is sewn When the valve skirt is located at the positions on both sides of the valve ear 3, the valve leaflet 2 can be fully expanded to match with the valve ear 3 in the closed state.

In a specific implementation manner, the above-mentioned valve holder 1 may be made of a shape memory alloy material, or may also be made of other elastic materials. The valve holder 1 made of this material can be deformed, and can be deformed during the process of implanting the valve prosthesis into the human body, so that the valve prosthesis can be easily implanted into the human body through the input device. After entering the human body, the valve holder 1 of this material can be restored It is deformed and has a certain rigidity, so that it can be used to support the leaflet 2 .

At the same time, since the valve leaflet 2 and the valve ear 3 are both flexible materials, the valve ear 3 can be pushed towards the valve leaflet 2 by the pushing force of the blood, and the valve leaflet 2 can be pushed towards the valve leaflet 2 by the pushing force of the blood. The valve ear 3 can make the valve leaflet 2 and the valve ear 3 butt against each other, so as to realize the sealing of the passage. Among them, it should be noted that during the periodical opening and closing process of the valve prosthesis, the valve ear 3 basically maintains the same posture, and does not participate in the same opening and closing action as the valve leaflet 2 .

As a specific implementation, in the open state, the ratio between the length occupied by the valve ear 3 in the circumferential direction of the valve holder 1 and the length of the valve leaflet 2 in the circumferential direction of the valve holder 1 is in the range of 0.1-0.6.

Among them, the length occupied by the valve ear 3 in the circumferential direction of the valve holder 1 is the connection length between the valve ear 3 and the valve holder 1, and the length of the valve leaflet 2 in the circumferential direction of the valve holder 1 refers to the open state of the valve prosthesis, The cross-sectional length of the valve leaflet 2 when it is close to the valve frame 1 after it is fully deployed.

Within this ratio range, it can be ensured that the valve leaflet 2 can be fully deployed in the closed or open state, and at the same time, the passage of the valve prosthesis can be effectively closed in the closed state to avoid blood reflux. In this embodiment, the specific ratio between the length occupied by the valve ear 3 in the circumferential direction of the valve holder 1 and the length of the valve leaflet 2 in the circumferential direction of the valve holder 1 may be 0.2, 0.3, 0.4 or 0.5.

In a specific implementation manner, as shown in FIG. 3 , in the closed state, a gap 31 is maintained between the two flaps 2 and the two flap ears 3 respectively. The gap 31 can absorb the deformation along the long diameter direction of the valve prosthesis after the two valve leaflets 2 are pressed against each other, so as to ensure the effective closure of the valve prosthesis passage.

In a specific implementation manner, since the mitral valve of the human body is a non-circular structure, in order to make the valve prosthesis more suitable for the human body, the cross section of the valve holder 1 can be a non-circular structure, and has a long The ratio of the major diameter to the minor diameter is 1.05-1.50.

Wherein, the ratio of the long diameter to the short diameter may specifically be 1.1, 1.2, 1.3, 1.4, and the like. Of course, the ratio of the long diameter to the short diameter of the valve holder 1 can be selected according to specific working conditions, as long as the long diameter and the short diameter of the valve holder 1 can be kept well sealed within this ratio range. Therefore, within this ratio range, the valve leaflet 2 can be maintained in a wide range of changes in the ratio of long and short diameters, which increases the fault tolerance of the valve prosthesis for the use environment, and better adapts to various long and short diameter ratios. Valve holder 1, reducing the central regurgitation of this valve prosthesis.

As a specific implementation, the cross section of the valve holder 1 can be a D-shaped or elliptical structure; the cross section of the valve holder 1 has a long diameter and a short diameter, and the two valve leaflets 2 are respectively arranged on both sides of the long diameter, The two flap ears 3 are respectively arranged at both ends of the long diameter.

Wherein, one end of each flap ear 3 is connected with the flap skirt, the bending portion 32 of the other end of each flap ear 3 can be formed on the straight line where the long diameter is located, and the flap ear 3 is located at two sides of the bending portion 32. The side parts that match with the leaflets 2 can be located on both sides of the long diameter respectively. When the middle parts of the two leaflets 2 are in the area between the two leaflets 3, the two ends of the two leaflets 2 are aligned. It can be matched with the two flap ears 3 respectively, so as to close the passage.

In one embodiment, the valve prosthesis is arranged at the mitral valve of the human body, and the valve prosthesis and the human aortic valve are opened and closed alternately, that is, when the aortic valve is opened, the valve prosthesis is closed, and the present In the embodiment, the cross-sectional area of the valve holder 1 is D-shape or ellipse, so that the valve prosthesis with D-shape or ellipse can avoid blocking the aortic valve when the valve prosthesis is deformed to the greatest extent.

At the same time, when the cross section of the valve holder 1 is D-shaped or elliptical, the stability of the valve prosthesis implantation is improved due to the strong anti-deformation capability of the elliptical or D-shaped structure in the longitudinal direction. In addition, the elliptical or D-shaped stent 1 structure can make the valve prosthesis work better, resulting in less regurgitation. It should be noted that, when the tri-leaflet valve prosthesis in the prior art includes three valve leaflets, the stent cannot be set to a non-circular structure, otherwise the tri-leaflet valve prosthesis cannot be closed. In the valve prosthesis in this embodiment, two valve leaflets 2 and two valve ears 3 are respectively disposed at opposite positions, so that the cross-section of the valve frame 1 can be a non-circular structure such as an oval or D-shaped structure, and The valve prosthesis can close normally.

As a specific implementation, as shown in FIG. 1 and FIG. 4 , the leaflet 2 has a first free end 21 , the above-mentioned free edge is formed at the edge of the first free end 21 , and the valve ear 3 has a second free end 33 , the second free end 33 is flush with the first free end 21 , or the second free end 33 protrudes from the first free end 21 .

Wherein, the first free end 21 is the end of the valve leaflet 2 that can close or open the passage by the pushing action of blood, and the second free end 33 is the end of the valve ear 3 that matches the first free end 21 .

In the closed state, the part of the valve leaflet 2 that is coinciding with the valve ear 3 can be completely fitted to the valve ear 3 . Wherein, making the second free end 33 protrude from the first free end 21 can prevent the valve leaflet 2 and the valve valve from being caused by the material characteristics or manufacturing errors of the valve leaflet 2 and the valve ear 3 during the manufacturing process of the valve prosthesis. The fitting precision of the ear 3 is reduced, which affects the sealing effect of the valve prosthesis passage.

As a specific implementation, when the cross section of the valve holder 1 is D-shaped or elliptical, the cross section of the valve holder 1 has a long diameter and a short diameter. In this embodiment, the valve holder 1 is located at the outlet 12 The ratio between the length of the minor axis at 2 and the height of the leaflet 2 is less than 2.1. The height of the valve leaflet 2 refers to the height dimension of the valve leaflet 2 in the axial direction of the valve holder 1 .

In this embodiment, if the height of the valve leaflet 2 is too small, the connection length between the valve leaflet 2 and the valve holder 1 in the axial direction is short, which leads to the valve leaflet 2 being easily leaked when it is compressed during the valve prosthesis closing process. , or the valve leaflet 2 is prone to inversion when being compressed, resulting in failure of the valve prosthesis. When the ratio between the length of the short diameter at the outlet 12 on the valve holder 1 and the height of the valve leaflet 2 is reduced, the force of the valve leaflet 2 is better, and the liquid is not easily leaked during the closing process, thereby further improving the The performance of valve prostheses.

Wherein, the side wall of the valve frame 1 can be a grid structure or a wire frame structure such as a wire frame structure, and the valve frame 1 of the grid structure or wire frame structure is more easily deformed, so that it is more convenient to implant the valve prosthesis human body. In addition, since the valve skirt is fixedly covered on the inner side of the valve holder 1, the grid structure or the wire frame structure of the valve holder 1 can be blocked, thereby preventing the blood entering the accommodating cavity from leaking from the grid structure. Specifically, the valve skirt can be a biological material or a flexible cloth.

As a specific implementation manner, the thickness of the leaflet 2 may be 0.25mm˜0.65mm. Specifically, the thickness of the leaflet 2 may be 0.3 mm, 0.4 mm, 0.5 mm, or the like. Of course, the actual thickness of the leaflet 2 can be set according to specific working conditions.

In the above embodiments, the two valve leaflets 2 and the two valve ears 3 can be arranged symmetrically or asymmetrically in the valve frame 1, and the two valve leaflets 2 can be of the same size and shape, or can be of the same size and shape. Structures with different shapes. The material of the valve leaflet 2 may include biological material or artificial flexible material, for example, the artificial flexible material may be a plastic composite material or a material such as cloth, and the biological material may be a processed animal pericardium or the like.

The application can be used for aortic, pulmonary, tricuspid, and mitral valves. Its characteristics are especially suitable for interventional mitral valve.

The above descriptions are only preferred embodiments of the present application, and are not intended to limit the present application. For those skilled in the art, the present application may have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of this application shall be included within the protection scope of this application.

Claims

A bicuspid valve prosthesis with valve ears, characterized in that it comprises:

A valve frame (1), a valve skirt is fixedly provided in the valve frame (1);

Two valve leaflets (2) are arranged in the valve frame (1) and are connected with the valve skirt;

Two flap ears (3) are arranged in the flap holder (1), and the flap ear (3) protrudes from the inner wall of the flap holder (1) to the interior of the flap holder (1);

Wherein, the bi-leaflet valve prosthesis with valve ears has an open state and a closed state, and in the closed state, between the two valve leaflets (2) and the two valve leaflets (2) are respectively connected with After the abutment between the two valve ears (3), the passage of the bicuspid valve prosthesis is blocked, and in the open state, the two valve leaflets (2) move toward the valve frame (1). ) are separated from each other to open the passage.
The bi-leaflet valve prosthesis with valve ears according to claim 1, characterized in that, the two side edges of the valve ears (3) are located on the two valve leaflets on the valve frame (1) After the positions on both sides of the abutting interface of (2) are connected, the flap ear (3) is formed with a bent portion (32) at one end away from the flap holder (1).
The bicuspid valve prosthesis with valve ears according to claim 1, characterized in that, in the open state, the length occupied by the valve ears (3) in the circumferential direction of the valve holder (1) is the same as the length of the valve ears (1). The ratio between the lengths of the valve leaflets (2) matched in the circumferential direction of the valve frame (1) ranges from 0.1 to 0.6.
The bicuspid valve prosthesis with valve ears according to claim 1, characterized in that the cross section of the valve holder (1) is a non-circular structure, and has a long diameter and a short diameter, and the long diameter is related to the The ratio of the short diameter is 1.05-1.50.
The bicuspid valve prosthesis with valve ears according to claim 1, wherein the cross section of the valve holder (1) is a D-shaped or elliptical structure;

The cross section of the valve holder (1) has a long diameter and a short diameter, two of the valve leaflets (2) are respectively arranged on both sides of the long diameter, and two of the valve ears (3) are respectively arranged on the two sides of the long diameter. both ends of the long diameter.
The bicuspid valve prosthesis with valve ears according to any one of claims 1 to 5, wherein the valve leaflets (2) have a first free end (21), and the valve ears (3) has a second free end (33), the second free end (33) is flush with the first free end (21), or the second free end (33) protrudes from the first free end (twenty one).
The bicuspid valve prosthesis with valve ears according to any one of claims 1-5, characterized in that, the thickness of the valve leaflets (2) is 0.25 mm to 0.65 mm.