Prosthetic valve and method of making

Abstract

The application relates to an artificial implant valve prosthesis, which comprises a valve frame and valve leaves integrally formed with the valve frame; the valve frame is provided with valve legs connected with the valve leaves; the valve leaves are provided with fixed edges connected to the valve frame and free edges, the free edges of the valve leaves can be attached to each other to form a closed state of the artificial valve; the valve leaves comprise a base layer and a reinforcing layer; wherein the reinforcing layer is a woven structure, and the reinforcing layer is connected to the valve legs. By adding the reinforcing layer to the valve leaves in addition to the base layer, and connecting the reinforcing layer to the valve legs, when the artificial implant valve is opened and closed, the reinforcing layer effectively disperses the stress at the position of the valve legs when the valve is opened and closed, and can play an auxiliary supporting role to assist the valve legs, thereby solving the problem of stress concentration at the position of the valve legs of the valve frame, reasonably improving the fatigue resistance of the valve frame, effectively improving the opening and closing times of the valve leaves, prolonging the service life, and reasonably reducing the replacement frequency of the artificial valve.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of artificial valve, in particular to an artificial implanted valve prosthesis and a preparation method thereof. BACKGROUND

[0002] An artificial heart valve should ideally last at least ten years in the body. The leaflets in an artificial heart valve should exhibit sufficient durability to circulate at least 400 million times or more. Structural degradation, including the formation of holes, cracks, etc., and adverse biological outcomes, including calcification and thrombosis, must be resisted.

[0003] Artificial valves are divided into two categories according to the materials used: one is made of artificial high polymer materials, called polymer valve, and the other is made of biological tissues, called biological valve.

[0004] Classification of biological valve: biological valve can be divided into two categories, xenogeneic valve and homologous valve. Among them, the xenogeneic valve includes pig aortic valve and bovine pericardium valve; the homologous valve includes fresh homologous aortic valve, autologous broad fascia valve and homologous dura mater valve. The advantage of biological valve is that it does not need to take anticoagulant drugs for life, but the disadvantage is that the service life is limited, and the biological valve will gradually change after about 20 years.

[0005] With the development of technology, the use rate of polymer valve has a trend of increasing more and more, but after a long time of use, the material is easy to fatigue, which causes a high rate of thromboembolism in the implanters.

[0006] In summary, in order to further improve the service life of artificial heart valve, the structural strength of heart valve still needs to be strengthened, so as to reduce the replacement frequency of artificial heart valve in the body of patients. SUMMARY

[0007] Therefore, the present application provides an artificial implanted valve prosthesis, which comprises a valve frame and valve leaflets formed on the valve frame; the valve frame has valve posts connected with the valve leaflets; the valve leaflets have fixed edges connected with the valve frame and free edges, and the free edges of the valve leaflets can be attached to each other to form a closed state of the artificial valve; the valve leaflets comprise a base layer and a reinforcing layer; and the reinforcing layer is connected with the valve posts.

[0008] In a possible implementation, one side of the reinforcing layer towards the free end of the valve post is a first layer, and the opposite side is a second layer; and the base layer covers the first layer of the reinforcing layer.

[0009] In a possible implementation, one side of the reinforcing layer towards the free end of the valve post is a first layer, and the opposite side is a second layer; and the base layer covers the first layer of the reinforcing layer.

[0010] In a possible implementation, the reinforcing layer has a first layer surface on one side towards the free end of the petal stem and a second layer surface on the opposite side; the base layer includes two layers, i.e., a first sub-layer and a second sub-layer; the first sub-layer covers the first layer surface of the reinforcing layer; the second sub-layer covers the second layer surface of the reinforcing layer and is attached to the inner wall of the petal frame at the edges; and the reinforcing layer is sandwiched between the second sub-layer and the first sub-layer.

[0011] In a possible implementation, the second sub-layer extends outward to cover the entire surface of the petal frame.

[0012] In a possible implementation, the first sub-layer extends outward to cover the reinforcing layer and the entire surface of the petal frame.

[0013] In a possible implementation, the reinforcing layer is a longitudinal woven strip including a fixed segment fixed to the outer periphery of the petal stem and a connecting segment attached to the free edge of the petal leaf.

[0014] In a possible implementation, the number of petal stems is three, and the number of fixed segments is the same as the number of petal stems, each fixed segment being fixed to a corresponding petal stem.

[0015] In a possible implementation, the reinforcing layer has a first layer surface on one side towards the free end of the petal stem and a second layer surface on the opposite side; the base layer includes a first sub-layer and a second sub-layer; the first sub-layer covers the first layer surface of the reinforcing layer; the second sub-layer covers the second layer surface of the reinforcing layer and is attached to the inner wall of the petal frame at the edges; and the reinforcing layer is sandwiched between the second sub-layer and the first sub-layer; the petal leaf further includes a wrapping layer wrapped around the outer periphery of the woven strip; the inner side of the wrapping layer is matched with the outer edge of the base layer to wrap the woven strip as a whole; and the shape of the wrapping layer is adapted to the shape of the outer periphery of the woven strip.

[0016] In a possible implementation, the petal frame has a flow passage, and in the closed state of the artificial valve formed by the free edges of the petal leaves abutting against each other, the highest point of the fixed edge of each petal leaf combined with the petal stem forms a vertex of the fixed edge, and the free edge of the petal leaf abuts against the free edge of another petal leaf to form a convergence point, the included angle between the line connecting the convergence point and the vertex of the fixed edge and the plane perpendicular to the flow direction of the flow passage is [15°-25°].

[0017] In a possible implementation, the petal leaf has a preset thickness; the thickness of the first sub-layer is greater than the thickness of the reinforcing layer; and the thickness of the second sub-layer is greater than the thickness of the reinforcing layer.

[0018] In a possible implementation, the second layer has the same thickness as the first layer.

[0019] In a possible implementation, the suture ring is in a structure of a cylinder with two open ends, and is arranged on the outer periphery of the frame. The frame has a flow opening, and the suture ring is arranged on the side of the frame close to the flow opening. The suture ring has a variable-diameter structure in the height direction, and the diameter of the suture ring close to the free end of the post is larger than the diameter of the suture ring close to the flow opening of the frame. The suture ring can extend into the aorta connected to the aortic valve or extend into the left atrium connected to the mitral valve.

[0020] In a possible implementation, the suture ring is provided with a bionic valve lip on the outer periphery close to the free end of the post. The bionic valve lip has an arc-shaped protrusion. The lip edge of the bionic valve lip is matched with the native valve ring structure of the aortic valve or the native valve ring structure of the mitral valve, and most of the arc-shaped protrusions correspond to the positions of the posts on the frame. An installation groove is arranged on the inner periphery of the bionic valve lip corresponding to each position of the post. A relief groove is arranged on the two sides of the installation groove and communicates with the installation groove. The depth of the relief groove in the radial direction of the bionic valve ring is less than or equal to the depth of the installation groove in the radial direction. The communication position of the relief groove and the installation groove is close to the top side of the post. The bottom of the installation groove is higher than or flush with the top of the variable-diameter structure. The lowest position of the relief groove is higher than or flush with the top of the variable-diameter structure, and the bottom of the frame is flush with the bottom of the suture ring.

[0021] In a possible implementation, the maximum height from the bottom of the suture ring to the lower end surface of the bionic valve ring is a first preset length, and the first preset length is within [2 mm, 6 mm].

[0022] In a possible implementation, the minimum position of the small-diameter end of the variable-diameter structure is flush with the minimum position of the bionic valve lip close to the flow opening direction of the frame.

[0023] In a possible implementation, the material of the frame is PEEK material containing barium sulfate.

[0024] In a possible implementation, the reinforcing layer is a woven structure.

[0025] In a possible implementation, the side of the frame close to the flow opening is the bottom, and a plurality of suture holes are arranged on the side wall close to the bottom of the frame. The suture holes are uniformly arranged in the circumferential direction of the frame.

[0026] In a possible implementation, the material of the base layer is pu material.

[0027] In a possible implementation, the reinforcing layer is pet high polymer material.

[0028] In a possible implementation, the reinforcing layer is ptfe material.

[0029] In another aspect, the application further provides a preparation method of the artificial implanted valve prosthesis, comprising the following steps: injection molding or machining molding the valve frame; and processing the inner and outer surfaces of the valve frame by using a plasma device.

[0030] In a possible implementation, the method comprises the following steps: before the valve frame is formed, barium sulfate is added to the material for forming the valve frame.

[0031] In a possible implementation, the method comprises the following steps: barium sulfate is added to the material for forming the suture ring.

[0032] In a possible implementation, the method comprises the following steps: after the valve frame is formed, a base layer of the valve leaflet is formed by dip coating a high polymer material on the valve frame; and a reinforcing layer of the valve leaflet is laid on the base layer.

[0033] In a possible implementation, the method comprises the following steps: a base layer is further dip coated on the reinforcing layer.

[0034] The application has the following beneficial effects: by adding the reinforcing layer to the valve leaflet in addition to the base layer, and connecting the reinforcing layer to the valve foot, when the artificial valve is opened and closed, the reinforcing layer effectively disperses the stress at the position of the valve foot during the opening and closing of the valve, and can assist the valve foot 11 to play a better supporting role, thereby solving the problem of stress concentration at the position of the valve foot, reasonably improving the fatigue resistance of the valve frame, effectively improving the opening and closing times of the valve leaflet, prolonging the service life, and reasonably reducing the replacement frequency of the artificial valve.

[0035] Other features and aspects of the application will become apparent from the following detailed description of the example embodiments, taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0036] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate example embodiments, features, and aspects of the application and serve to explain the principles of the application.

[0037] Figure 1 FIG. 1 shows a side structure schematic diagram of an artificial implanted valve prosthesis suitable for a mitral valve according to an embodiment of the application;

[0038] Figure 2Fig. 6 shows a side view of a structure of a prosthetic implant valve prosthesis suitable for a mitral valve according to another embodiment of the present application;

[0039] Figure 3 Fig. 7 shows a bottom view of a structure of a prosthetic implant valve prosthesis suitable for a mitral valve according to another embodiment of the present application;

[0040] Figure 4 Fig. 8 shows a side view of a structure of a prosthetic implant valve prosthesis suitable for an aortic valve according to an embodiment of the present application;

[0041] Figure 5 Fig. 9 shows a cross-sectional view of a structure of a prosthetic implant valve prosthesis suitable for an aortic valve according to an embodiment of the present application;

[0042] Figure 6 Fig. 10 shows a perspective view of a structure of a suture ring suitable for an aortic valve according to an embodiment of the present application;

[0043] Figure 7 Fig. 11 shows a perspective view of a structure of a suture ring suitable for a mitral valve according to an embodiment of the present application;

[0044] Figure 8 Fig. 12 shows a partial cross-sectional view of a structure of a leaflet multi-layer according to an embodiment of the present application;

[0045] Figure 9 Fig. 13 shows a side view of a structure of a prosthetic implant valve prosthesis suitable for a mitral valve according to an embodiment of the present application;

[0046] Figure 10 Fig. 14 shows a structure of a frame with leaflets according to an embodiment of the present application;

[0047] Figure 11 Fig. 15 shows a partial cross-sectional view of a structure of a leaflet with a wrapping layer according to an embodiment of the present application. DETAILED DESCRIPTION

[0048] Various exemplary embodiments, features, and aspects of the present application will be described herein below with reference to the accompanying drawings. Like reference numerals in the drawings denote functionally the same or similar elements. Although various aspects of the embodiments are illustrated in the drawings, the drawings are not necessarily drawn to scale unless specifically stated.

[0049] It should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate relative or positional relationships based on the orientation or position shown in the drawings, and are used only for convenience in describing the present application or simplifying the description, and thus cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be construed as limiting the present application.

[0050] In addition, the terms "first", "second", "third", etc. are used only for descriptive purposes and are not to be construed as indicating or implying relative importance or an ordered ranking of the indicated technical features. Thus, features defined with "first", "second" or "third" can include one or more of the features explicitly or implicitly. In the description of the present application, the meaning of "a plurality of" is two or more, unless otherwise expressly and specifically limited.

[0051] The term "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any implementation described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other implementations.

[0052] In addition, in order to better illustrate the present application, a large number of specific details are given in the specific embodiments below. Those skilled in the art should understand that the present application can also be implemented without some specific details. In some examples, methods, means, elements and circuits well known to those skilled in the art are not described in detail, in order to highlight the main ideas of the present application.

[0053] Figure 1 Fig. 1 shows a side view of a structure of an artificial implanted valve prosthesis suitable for a mitral valve according to an embodiment of the present application; Figure 2 Fig. 2 shows a side view of a structure of an artificial implanted valve prosthesis suitable for a mitral valve according to another embodiment of the present application; Figure 3 Fig. 3 shows a plan view of a structure of an artificial implanted valve prosthesis suitable for a mitral valve according to another embodiment of the present application; Figure 4 Fig. 4 shows a side view of a structure of an artificial implanted valve prosthesis suitable for an aortic valve according to an embodiment of the present application; Figure 5 Fig. 5 shows a cross-sectional view of a structure of an artificial implanted valve prosthesis suitable for an aortic valve according to an embodiment of the present application; Figure 6 Fig. 6 shows a perspective view of a structure of a suture ring suitable for an aortic valve according to an embodiment of the present application; Figure 7 Fig. 7 shows a perspective view of a structure of a suture ring suitable for a mitral valve according to an embodiment of the present application; Figure 8 Fig. 8 shows a partial cross-sectional view of a structure of a three-layered leaflet according to an embodiment of the present application;Figure 9 Fig. 3 shows a schematic view of a side structure of an artificial implanted valve prosthesis according to an embodiment of the present application; Figure 10 Fig. 4 shows a schematic view of a structure of a valve frame with valve leaflets according to an embodiment of the present application; Figure 11 Fig. 5 shows a schematic view of a partial cross-section of a valve leaflet with a wrapping layer according to an embodiment of the present application.

[0054] As shown in Figure 1 , Figure 2 and Figure 8 , an artificial implanted valve prosthesis comprises a valve frame 10 and valve leaflets 20 integrally formed with the valve frame 10; the valve frame 10 has valve posts 11 connecting the valve leaflets 20; the valve leaflets 20 have fixed edges 25 connected to the valve frame 10 and free edges 24, the free edges 24 of the valve leaflets 20 can be mutually abutted to form a closed state of the artificial valve; the valve leaflets 20 comprise base layers 21 and reinforcing layers 22; wherein the reinforcing layers 22 are of a woven structure, and the reinforcing layers 22 are connected to the valve posts 11.

[0055] In this embodiment, in addition to the base layers 21, reinforcing layers 22 are added to the valve leaflets 20, the edges of the reinforcing layers 22 can be connected to the valve posts 11, during the opening and closing actions of the implanted artificial valve, the positions of the valve posts 11 are the main stress points and prone to stress concentration, the reinforcing layers 22 can disperse the stress at the positions of the valve posts 11 during the opening and closing of the valve, and can assist the valve posts 11 to play a better supporting role, solving the problem of stress concentration at the positions of the valve posts 11 of the valve frame 10, thereby reasonably improving the fatigue resistance of the valve frame 10, effectively improving the opening and closing times of the valve leaflets 20, achieving the extension of the service life, and reducing the replacement frequency of the artificial implanted valve.

[0056] As shown in Figure 8 , Figure 10 , in one specific embodiment, the artificial implanted valve prosthesis comprises a valve frame 10 and a plurality of valve leaflets 20 integrally formed inside the valve frame 10, the valve frame 10 has a plurality of valve posts 11 and a flow passage, each valve leaflet 20 is arranged between two adjacent valve posts 11, the valve leaflet 20 has a fixed edge 25 connected to the valve frame 10 and a free edge 24, the highest point of the combination of the fixed edge 25 of the valve leaflet 20 and the valve post 11 forms an apex 27 of the fixed edge 25, and the free edges 24 of the valve leaflets 20 can be mutually abutted to form a closed state of the artificial valve.

[0057] Further, the leaflet 20 is a multi-layer structure, comprising a reinforcing layer 22 and a base layer 21. The reinforcing layer 22 is a layer of woven high polymer material connected to the edge of the post 11, or a longitudinal woven ring, and the reinforcing layer 22 is annularly arranged at the corresponding position of the post 11, and the rest of the reinforcing layer 22 has the same structure as the free edge 24 of the leaflet 20, i.e., a longitudinal woven ring, comprising a fixed segment 222 annularly arranged at the outer periphery of the post 11 and a connecting segment 221 connecting two adjacent fixed segments 222, and the structure of the connecting segment 221 is the same as that of the free edge 24 of the leaflet 20; the first layer 223 of the reinforcing layer 22 is located at the side of the free end of the post 11, and the second layer 224 is located at the side of the flow passage.

[0058] It should be particularly emphasized that the reinforcing layer 22 can be a woven layer structure covering the entire layer, or a longitudinal woven ring structure matched with the outer contour of the leaflet 22, as shown in Figure 2 、 3 , that is, the reinforcing layer 22 under the longitudinal woven ring structure is hollow except for a “reinforcing rib” matched with the outer contour, and the woven structure is usually made of high polymer material.

[0059] It should be further noted that the flow direction refers to the direction of blood flowing through the flow passage, and in the embodiment, the blood flow direction is generally consistent with the extension direction of the post 11. If it is reflected in the drawings, please refer to Figure 1 , Figure 1 , the top, bottom and up-down direction in the drawings is the direction of blood flowing through the flow passage, and the free end of the post 11 of the frame 10 is the top, and the direction of the flow passage of the frame 10 is the bottom. Figure 2 , the horizontal plane perpendicular to the up-down direction is the plane perpendicular to the flow direction of the flow passage. In addition, the post 11 referred to in the present application is a support structure protruding from the annular part of the frame 10 to one side, and the post 11 plays a major supporting role when the leaflet 20 is opened and closed. The free end of the post 11 is opposite to the direction in which the flow passage is arranged on the frame 10, and the free end of the post 11 is a circular arc structure that can reduce the damage to the heart caused by the artificial implant such as the frame 10 as much as possible.

[0060] In one specific embodiment, the reinforcing layer 22 is a woven structure.

[0061] As shown in Figure 3 , in one specific embodiment, the reinforcing layer 22 is a longitudinal woven ring, comprising a fixed segment 222 annularly arranged at the outer periphery of the post 11 and a connecting segment 221 connecting two adjacent fixed segments 222, and the structure of the connecting segment 221 is the same as that of the free edge 24 of the leaflet 20.

[0062] As shown in Figure 8As shown, in one of the specific embodiments, the reinforcing layer 22 has a first layer surface 223 on the side towards the free end of the petal leg 11 and a second layer surface 224 on the side towards the flow passage.

[0063] In this embodiment, the reinforcing layer 22 covering the first layer surface 223 of the reinforcing layer 22 can effectively avoid stress concentration at the position of the petal leg 11, and compared with the technical solution of sandwiching the reinforcing layer 22 by the first sub-layer 21 and the second sub-layer 23, the structure is simple, easier to produce and prepare, and has the advantage of low cost.

[0064] As shown, Figure 1 In one of the specific embodiments, when the reinforcing layer 22 is a polymer woven layer, the edge of the polymer woven layer is fixed to the petal leg 11 of the petal frame 10.

[0065] As shown, Figure 3 In one of the specific embodiments, the reinforcing layer 22 is a longitudinal woven ring, which includes a fixed segment 222 fixed to the outer periphery of the petal leg 11 and a connecting segment 221 attached to the free edge of the petal leaf 20.

[0066] In this embodiment, the longitudinal woven ring can be a longitudinal woven ring composed of multiple segments of woven wires connected together, the fixed segment 222 of the longitudinal woven ring is fixedly installed on the outer periphery of the petal leg, the connecting segment 221 connects two adjacent fixed segments 222, and the outer contour structure of the connecting segment 221 can be consistent with the structure of the free edge of the petal leaf 20, or the outer contour structure of the connecting segment 221 can be slightly smaller than the structure of the free edge of the petal leaf 20.

[0067] The multiple segments of woven wires connected together to form the longitudinal woven ring are usually connected at the connection points between the fixed segment 222 and the connecting segment 221, and when forming, one end of the fixed segment 222 can be slightly inclined upward, and the end of the connecting segment 221 adjacent to the fixed segment 222 can be slightly inclined downward, so that the fixed segment 222 and the connecting segment 221 are connected to each other, the contact area of the connection position is increased, and the structural strength of the connection position is effectively improved.

[0068] In one of the specific embodiments, the number of petal legs 11 is three, the number of fixed segments 222 is the same as the number of petal legs 11, and each fixed segment 222 is fixed to the corresponding petal leg 11.

[0069] As shown, Figure 3As shown, further, in one specific embodiment, the number of petal legs 11 on the petal frame 10 is three, and the reinforcing layer 22 is a long knitted ring in a preset shape, which is sleeved and fixed on the plurality of petal legs 11 of the petal frame 10. The projection of the long knitted ring in the flow direction of the flow passage is substantially a fan-shaped leaf with three sharp corners, each of which corresponds to the position where the long knitted ring is sleeved and fixed on the outer periphery of the petal leg. The three sharp corners of the fan-shaped leaf divide the remaining long knitted ring into three connecting lines, and the shape of each connecting line is consistent with the structure of the free edge of the valve leaflet.

[0070] The reinforcing layer 22 has a first layer surface 223 on the side facing the free end of the petal leg 11 and a second layer surface 224 on the side facing the flow passage. The base layer 21 covers at least the first layer surface 223 of the reinforcing layer 22, and the base layer 21 extends outwardly to cover the first layer surface 223 of the reinforcing layer 22.

[0071] In this embodiment, the valve leaflet 20 with a multi-layer structure includes a reinforcing layer 22 and at least a base layer 21 covering the reinforcing layer 22 on the side facing the free end of the petal leg 11, which is arranged on the petal frame 10. The direction of the free end of the petal leg 11 is opposite to the direction in which the flow passage is opened on the petal frame 10.

[0072] In this embodiment, the arrangement of the reinforcing layer 22 in the base layer adds a reinforcing rib structure to the valve leaflet 20 itself, effectively increasing the number of opening and closing times of the valve leaflet 20, prolonging its service life, and reasonably reducing the replacement frequency of the artificial implantable valve prosthesis. Furthermore, the edge of the reinforcing layer 22 is fixed to the petal leg 11, enhancing the integration of the petal frame 10 and the valve leaflet 20. When the artificial implantable valve prosthesis is opened and closed, the reinforcing layer 22 can assist the petal leg 11 in supporting, dispersing the stress at the position of the petal leg 11 when the valve is opened and closed, thereby solving the problem of stress concentration at the position of the petal leg 11 of the petal frame 10 and reasonably improving the fatigue resistance of the petal frame 10.

[0073] Further, by integrally forming a plurality of valve leaflets 20 on the inner side of the petal frame 10, the free edge 24 of the valve leaflet 20 can be opened to a preset position or closed to cover the flow passage in the petal frame 10. The integrally formed plurality of valve leaflets 20 are more uniform in stress and have better consistency. Therefore, only the mold for integral formation needs to be set to form the valve leaflet 20 with the corresponding shape, improving the controllability of the shape of the valve leaflet 20.

[0074] As shown in FIG. 1, the artificial implantable valve prosthesis 1 includes a petal frame 10 and a plurality of valve leaflets 20 arranged on the inner side of the petal frame 10. Figure 8 , Figure 11As shown, in one embodiment, the leaflet 20 is a three-layer structure, the base layer includes a first layer 21 and a second layer 23, the flow passage of the frame 10 is the bottom, the post 11 extends from the bottom to the top, the first layer 21 covers the first surface 223 of the reinforcing layer 22, the middle of the second layer 23 covers the second surface 224 of the reinforcing layer 22, and the edge is attached to the inner wall of the frame 10, and the reinforcing layer 22 is sandwiched between the second layer 23 and the first layer 21.

[0075] In this embodiment, the base layer includes a first layer 21 and a second layer 23, the first layer 21 is attached to and covers the first surface 223 of the reinforcing layer 22, and the middle of the second layer 23 is attached to and covers the bottom of the reinforcing layer 22, that is, the reinforcing layer 22 is sandwiched between the first layer 21 and the second layer 23. The three-layer structure of the leaflet 20 has better quality and higher structural strength after molding than the two-layer structure that only covers the first surface 223 of the reinforcing layer 22, and the first layer 21 and the second layer 22 wrap the reinforcing layer 22 from the first surface 223 and the second surface 224 of the reinforcing layer 22, so that the leaflet 20 and the frame 10 have better fusion after molding. More specifically, since the leaflet 20 itself is relatively thin, the reinforcing layer 22 inside it is also relatively thin, and the three-layer structure is easier to achieve, and the molding rate of the leaflet with two or more layers is the highest.

[0076] It should be specifically pointed out that the reinforcing layer 22 is usually a fiber layer pre-woven on a weaving machine, or a fiber yarn, with a thickness of about 0.05mm.

[0077] In one embodiment, the leaflet 20 is a two-layer structure, the edge of the reinforcing layer 22 is fixed to the post 11, and the first layer 21 is covered on the first surface 223 of the reinforcing layer 22.

[0078] In one embodiment, the first layer 21 extends outward to cover the reinforcing layer 22 and the surface of the entire frame 10, and the second layer 23 extends outward to cover the surface of the entire frame 10.

[0079] In this embodiment, the second layer 23 formed on the frame 10 extends outwardly and covers the surface of the frame 10. The forming method can be as follows: the frame 10 is placed in a solution of the base material, and then processed so that the second layer 23 forms a thin film covering the surface of the frame 10. After the film is cooled and solidified, the reinforcing layer 22 is installed on the frame 10, and a second layer 23 is covered on the frame 10. The first layer 21 is more easily covered on the reinforcing layer 22. The reinforcing layer 22 is wrapped in the middle of the second layer 23 and the first layer 21 to form a structure similar to a sandwich. This ensures that the leaflet 20 has a reinforcing structure and is firmly connected to the frame 10, has good bonding strength, and has a higher degree of integration of the frame 10 and the leaflet 20. The stress of the plurality of leaflets 20 is more uniform.

[0080] In one specific embodiment, the first layer 21 extends outwardly and covers the surface of the reinforcing layer 22 and the frame 10.

[0081] In this embodiment, the first layer 21 covering the first layer 223 of the reinforcing layer 22 is formed by immersing the reinforcing layer 22 formed on the frame 10 or the frame 10 with the reinforcing layer 22 and the second layer 23 formed thereon in a solution of the first layer 21. That is, the first layer 21 covers at least part of the inner surface of the frame 11 and the outer surface of the frame 10 in addition to the first layer 223 of the reinforcing layer 22, so that the connection between the leaflet 20 and the frame 10 is more secure.

[0082] As shown in Figure 1 In one specific embodiment, when the reinforcing layer 22 is a high-molecular woven layer, the middle part of the high-molecular woven layer is slightly smaller than the partial spherical structure of the first layer 21, and the edge of the high-molecular woven layer at the position of the frame 11 covers the free end of the frame 11.

[0083] In this embodiment, the force of the leaflet 20 is mainly used at the position of the free end of the frame 11. The high-molecular woven layer only covers the free end of the frame 11, which ensures that the high-molecular woven layer is firmly installed at the free end of the frame 11 and plays a supporting role for the overall structure when the leaflet 20 is in motion, thereby reducing costs and effectively avoiding stress concentration. Furthermore, when the high-molecular woven layer covers the remaining part of the frame 10, the restraint and fastening of the frame are too high, which affects the toughness of the frame 10 and reduces the opening and closing amplitude of the leaflet 20, which is not conducive to the opening and closing motion of the artificial valve prosthesis after implantation.

[0084] In one embodiment, the second layer 23 is made of the same material as the first layer 21.

[0085] In this embodiment, the second layer 23 is made of the same material as the first layer 21, which can better connect the contact position of the two-layer structure. Compared with the connection between different materials, the same material has better compatibility. In addition, the use of the second layer 23 made of the same material as the first layer 21 and the forming of the plurality of leaflets 20 on the frame 10 together improves the stability and consistency of the leaflets 20 on the frame 10.

[0086] In addition, the artificial implant valve prosthesis of the present application does not use any metal parts and animal tissues, and platelets are not easy to adhere to the frame 10 or the leaflets 20, so there is no need for anticoagulation, and the patient does not need to take harmful drugs such as antibiotics for a lifetime.

[0087] In one embodiment, the first layer 21 and the second layer 23 are made of the same material.

[0088] In one embodiment, the first layer 21 and the second layer 23 are made of pu material.

[0089] Preferably, the first layer 21 and the second layer 23 are made of polyurethane.

[0090] In one embodiment, the reinforcing layer 22 is made of pet high molecular material or ptfe material.

[0091] Preferably, when the reinforcing layer 22 is a high molecular woven layer, the reinforcing layer 22 is made of pet high molecular material.

[0092] Preferably, when the reinforcing layer 22 is a longitudinal woven ring, it is made of ptfe material.

[0093] In one embodiment, when the leaflets 20 are in the closed position, the leaflets 20 are partially spherical structures, and the convex direction of the spherical structure is towards the free end away from the post 11.

[0094] In this embodiment, the leaflets 20 are all partially spherical structures, and each leaflet 20 has the same structure. Preferably, the radius of the circular arc of the leaflet 20 is within [20mm, 40mm].

[0095] As Figure 9 , Figure 10As shown, in one embodiment, the free edge 24 of each leaflet 20 forms a convergence point 26 with the free edge 24 of the other leaflets 20 when the free edge 24 of the leaflet 20 is in a closed state of the artificial valve, and the convergence point 26 forms an angle a with the line connecting the vertex 27 of the fixed edge 25 and the plane perpendicular to the flow direction of the flow passage, and the angle a is in the range of 15°-25°.

[0096] In this embodiment, the convergence point 26 in the lowest position is the position of the leaflet 20 when the leaflet 20 is closed, and the convergence point 26 of the free edge 24 of the leaflet 20 is lower than the vertex 27 of the fixed edge 25, which ensures that the plurality of leaflets 20 can completely cover the flow passage and effectively close, and the structure of the leaflet 20 is more reasonable, so that the opening and closing position of the leaflet 20 has a shorter displacement amount, so as to increase the working efficiency of the artificial valve implanted by the surgical method of the present application and prolong the service life.

[0097] More specifically, the flow passage is an opening in the inner side of the valve frame 10, the edge of the valve frame 10 is provided with two or more than two valve legs 11, the number of leaflets 20 is multiple, the leaflet 20 has a fixed edge 25 connected to the inner side of the valve frame 10, and a free edge 24 moving between an open position and a closed position in the valve frame 10, the leaflet 20 is arranged between two adjacent valve legs 11, and in the closed state of the leaflet 20, the convergence point 26 of the free edge 24 forms an angle a with the line connecting the vertex 27 of the fixed edge 25 and the plane perpendicular to the flow direction of the flow passage, and the angle a is [15°-25°], as shown. Figure 3 That is, the line connecting the highest point of the free edge 24 of the leaflet 20 and the vertex 27 of the fixed edge 25 of the leaflet 20 forms an angle a with the plane perpendicular to the flow direction in the flow passage, and the angle a is [15°, 25°].

[0098] In this embodiment, the free edge 24 of the leaflet 20 can be opened to a preset position within the frame 10 or closed to cover the flow passage by connecting the fixed edge 25 of the leaflet 20 to the inner side of the frame 10. The leaflet 20 is generally arc-shaped, and each leaflet 20 is arranged between two adjacent petal stems 11. The plurality of leaflets 20 are integrally formed on the frame 10, and the stress of the plurality of leaflets 20 is more uniform, has better consistency, and the integrally formed leaflets 20 can be formed into the corresponding shape of the leaflet 20 by setting the mold during the integral forming, thereby improving the controllability of the shape of the leaflet 20. Furthermore, the angle between the straight line connecting the fixed edge 25 top point 27 of the leaflet 20 and the convergence point 26 of the free edge 24 of the leaflet 20 in the closed state and the plane perpendicular to the flow passage is [15°, 25°], that is, the two top points 27 of the fixed edge 25 of the leaflet 20 between the two adjacent petal stems 11 and the convergence point 26 in the lowest position, the above three endpoints further limit the shape of the leaflet 20 and determine the overall structure of the leaflet 20. In summary, the integrally formed leaflet 20 on the frame 10 is combined with the three endpoints described above within the range of 15°-25° to obtain the leaflet 20 provided on the frame 10 in this application, which has a more optimal arc surface and a more optimal overall structure. When opening and closing, it has the advantage of a larger flow passage area, and further reduces the transvalvular pressure difference on both sides of the heart valve under the premise of solving the valve stenosis index, and establishes similar blood dynamics and blood flow to the human heart valve.

[0099] It should be further pointed out that the position of the two fixed edge top points 27 of each leaflet 20 can be completely the same or slightly different, as long as the angle α between the straight line connecting the convergence point 26 of the free edge 24 and the plane perpendicular to the flow passage is within [15°, 25°].

[0100] As shown in Figure 8 In one specific embodiment, the leaflet 20 has a preset thickness perpendicular to the flow direction of the flow passage, wherein the thickness of the first layer 21 is greater than the thickness of the reinforcing layer 22, and the thickness of the second layer 23 is greater than the thickness of the reinforcing layer 22.

[0101] In one specific embodiment, the thickness of the second layer 23 is the same as that of the first layer 21.

[0102] In the above two embodiments, the thickness of the leaflet 20 is uniform, and the thickness of the second layer 23 and the first layer 21 is greater than the thickness of the reinforcing layer 22. The thickness of the first layer 21 and the second layer 23 can be the same or different, which is not limited here.

[0103] As shown in Figures 5-7As shown, in one specific embodiment, a suture ring 30 is included. The suture ring 30 has a cylindrical structure with open ends and is arranged around the outer periphery of the flap 10 and downward.

[0104] In this embodiment, the valve frame 10 is typically sewn onto the suture ring 30 and eventually sewn onto the aortic or mitral valve of the human body. Once the suture is in place, the structure transforms the dynamic aortic valve ring into a fixed structure.

[0105] like Figure 4 As shown, in one specific embodiment, the suture ring 30 has a variable diameter structure 33 in its radial direction, with the large diameter end 32 adjacent to the free end of the valve foot 11 and the small diameter end 34 adjacent to the flow port of the valve frame 10. The suture ring 30 can extend into the aorta connected to the aortic valve or into the left atrium connected to the mitral valve.

[0106] In this embodiment, the suture ring 30 has a diameter-changing structure 33 in its radial direction. The diameter-changing structure 33 is usually located in the middle of the cylindrical suture ring 30. The large diameter end 32 is the end of the suture ring 30 near the free end of the valve foot 11, and the small diameter end is the end of the suture ring 30 near the flow direction of the flow port. With this diameter-changing structure 33, the small diameter end 34 of the suture ring 30 can more easily extend into the aorta connected to the aortic valve, or the small diameter end 34 of the suture ring 30 can extend into the left atrium connected to the mitral valve. That is, through the cylindrical suture ring 30 with the diameter-changing structure 33, it can be repositioned in the aorta and the left atrium, making full use of the space connecting the ventricle and the atrium, and reducing the space occupied in the atrium.

[0107] More specifically, when the implantable artificial valve with the polymer braided structure of this application is inserted into the aorta, because its insertion depth in the aorta is relatively shallow, the use of this variable diameter suture ring 30 can further reduce the distance that the other end of the valve frame 10 extends into the left ventricle without obstructing the blood flow of the coronary arteries on the side of the aorta, thereby reducing the space it occupies in the left ventricle and reducing the damage of the artificial implanted valve to the heart.

[0108] like Figure 9 As shown, in one specific embodiment, the suture ring 30 has a first preset length b extending axially into the aorta or left atrium, the first preset length b being within [2 mm, 6 mm].

[0109] In this embodiment, the length of the first preset length b in the range of [2 mm, 6 mm] refers to the distance by which the suture ring 30 is displaced in the left ventricle or left atrium in its axial direction.

[0110] The overall height of the petal holder 10 from bottom to top is within [11mm, 19mm].

[0111] likeFigures 4-6 As shown, in one of the specific embodiments, the outer circumferential ring of the suture ring 30 towards the side of the free end of the leaflet 11 is provided with a bionic valve lip 31, and the bionic valve lip 31 has an arc-shaped protrusion 311. The lip edge of the bionic valve lip 31 is adapted to the native valve annulus structure of the aortic valve or the native valve annulus structure of the mitral valve, and most of the arc-shaped protrusions 311 correspond to the positions of the leaflets 11 on the valve frame 10.

[0112] In this embodiment, the outer circumferential ring of the suture ring 30 towards the side of the free end of the leaflet 11 is provided with a bionic valve lip 31, and the outer circumferential ring of the suture ring 30 towards the side of the free end of the leaflet 11 is provided with a bionic valve lip 31. The bionic valve lip 31 has a ring structure and has undulations in the circumferential direction, forming a plurality of arc-shaped protrusions 311.

[0113] As shown, Figure 6 When the bionic valve lip 31 is adapted to the native valve annulus structure of the aortic valve, the bionic valve lip 31 has three arc-shaped protrusions 311, which are uniformly arranged on the bionic valve lip 31, and the included angle between the connecting lines of the adjacent two arc-shaped protrusions 311 and the ring center of the bionic valve lip 31 is 120°. The midpoint of the arc-shaped protrusion 311 coincides with the midpoint of the three leaflets 11 on the corresponding valve frame 10 in the axial direction.

[0114] As shown, Figure 7 When the bionic valve lip 31 is adapted to the native valve annulus structure of the mitral valve, the bionic valve lip 31 has two arc-shaped protrusions 311, which divide the ring circumference into 120° and 240°. The number of leaflets 11 of the valve frame 10 is three, and the midpoints of the two leaflets 11 in the axial direction coincide with the midpoints of the two arc-shaped protrusions 311 on the bionic valve lip 31.

[0115] As shown, Figure 4 In one of the specific embodiments, the setting position of the variable diameter structure 33 is flush with the lowest position of the bionic valve lip 31.

[0116] In this embodiment, the lowest position of the bionic valve lip 31 is located near the bottom side of the valve frame 10, that is, the lowest position of the variable diameter structure 33 is the lowest point of the arc-shaped protrusion, and specifically, the lowest position of the variable diameter structure 33 is flush with the top of the small-diameter end 34.

[0117] As shown, Figure 6 In one of the specific embodiments, the inner circumferential direction of the bionic valve lip 31 is provided with a mounting groove 312 corresponding to the position of each leaflet 11.

[0118] In this embodiment, the inner circumference of the bionic cusp lip 31 is provided with a mounting groove 312, which is provided from top to bottom. The structure of the mounting groove 312 matches the structure of the cusp foot 11 on the cusp foot 11, which is a ladder-shaped groove structure with a short top and a long bottom. The provision of the mounting groove 312 effectively reduces the thickness of the bionic cusp lip 31 in the radial direction, reducing the impact of the excessively thick bionic cusp lip 31 on the reduction of the maximum opening area of the implantable artificial valve prosthesis.

[0119] As shown in Figure 6 one of the specific embodiments, the mounting groove 312 is provided with a clearance groove 313 on each side of the inner circumference of the bionic cusp lip 31, which is in communication with the mounting groove 312. The radial depth of the clearance groove 313 is less than or equal to the depth of the mounting groove 312 in this direction.

[0120] In one of the specific embodiments, the communication position of the clearance groove 313 and the mounting groove 312 is close to the top side of the cusp foot 11. The bottom of the mounting groove 312 is higher than the variable diameter structure 33 or is flush with the top of the variable diameter structure 33. The lowest position of the clearance groove 313 is higher than the variable diameter structure 33 or is flush with the top of the variable diameter structure 33.

[0121] In the above embodiment, the mounting groove 312 is provided with a clearance groove 313 on each side of the inner circumference of the bionic cusp lip 31, which is in communication with the two sides of the mounting groove 312. The provision of the clearance groove 313 reduces the thickness of the bionic cusp ring cusp lip 31, thereby effectively improving the overall circumferential flexibility of the suture ring 30. During the opening and closing of the implantable artificial valve prosthesis, the insufficient flexibility of the suture ring 30 can cause the opening area of the valve leaflet 20 to be small, the overall service life of the implantable artificial valve prosthesis to be low, and many other problems.

[0122] As shown in Figure 5 one of the specific embodiments, a plurality of suture holes 12 are provided on the side wall near the bottom of the cusp frame 10. The suture holes 12 are uniformly provided in the circumferential direction of the cusp frame 10, and the bottom of the cusp frame 10 is flush with the bottom of the suture ring 30.

[0123] In this embodiment, the side wall near the bottom of the cusp frame 10 is uniformly provided with a plurality of suture holes 12 in the circumferential direction. The suture holes 12 are located at the bottom of the suture ring 30, and the suture ring 30 is wrapped in the outer circumferential direction of the cusp frame 10. The suture ring 30 and the cusp frame 10 are sewn to the specified positions of the corresponding mitral valve and aortic valve by a suture needle.

[0124] As shown in Figure 9 one of the specific embodiments, the maximum length of the cusp frame 10 extending into the left ventricle is a second predetermined length c, and the second predetermined length c is within [8mm, 16mm].

[0125] In this embodiment, the second preset length c of the frame 10 extending into the left ventricle is the height from the lowest position of the arc-shaped protrusion 311 on the bionic valve lip 31 to the top of the frame 10, which is within [8mm, 16mm].

[0126] In one specific embodiment, the melting point of the frame 10 is lower than that of the valve leaflet 20.

[0127] In this embodiment, the melting point of the frame 10 is lower than that of the valve leaflet 20, so that when the frame 10 is immersed in the solution of the first layer 21 or the second layer 23, the formed frame 10 itself will not melt together, resulting in failure of forming.

[0128] In one specific embodiment, the material of the frame 10 is PEEK material containing barium sulfate.

[0129] In this embodiment, the material of the frame 10 is PEEK material containing barium sulfate, which is a natural mineral that is insoluble in water and acid, chemically stable, non-magnetic and non-toxic, and has the performance of absorbing X-rays and gamma rays. By mixing a certain amount of barium sulfate with peek powder, the frame 10 with certain linear performance is formed by injection molding process.

[0130] In one specific embodiment, the surface of the frame 10 is coated with ions.

[0131] In this embodiment, the frame 10 is subjected to modification treatment, i.e. plasma treatment on the surface of the frame 10 to enhance the development effect; the plasma treatment improves the wettability of the frame 10 and the solution of the valve leaflet 20, and improves the adhesion between the frame 10 and the valve leaflet 20; the barium sulfate development effect can improve the CT development during or after the operation, and is not affected by nuclear magnetic resonance detection. The outer and inner surfaces of the frame 10 are uniformly sprayed by the plasma spraying equipment: firstly, the plasma treatment improves the roughness of the surface of the frame 10, increases the bonding area with the solution, and thus improves the adhesion of the valve leaflet 20 on the frame 10; in addition, after the plasma treatment, the surface of the peek material introduces polar groups such as hydroxyl, amino and carboxyl, which increases the adhesion between the frame 10 made of PEEK material and the solution, and thus improves the bonding strength.

[0132] On the other hand, the application also provides a preparation method of an artificial implantable valve prosthesis, which comprises the following steps: injection molding or machining molding the frame; and using a plasma device to treat the inner and outer surfaces of the frame.

[0133] In one specific embodiment, the method comprises the following steps: adding barium sulfate to the material for forming the frame before forming the frame.

[0134] In one embodiment, the method comprises the step of adding barium sulfate to the material used to form the sewing ring.

[0135] In one embodiment, the method comprises the steps of: dip-coating a base layer 21 of the leaflet 20 on the shaped frame 10; and laying a reinforcing layer 22 of the leaflet 20 on the base layer 21.

[0136] In one embodiment, the method comprises the step of dip-coating a base layer 21 on the reinforcing layer 22.

[0137] More specifically, the method comprises the steps of: using a first mold to form the frame 10; and using a second mold to form the leaflet 20 on the frame 10. The base layer 21 and the reinforcing layer 22 are formed on the frame 10 from the flow-through opening to the foot 11 of the frame 10.

[0138] In summary, the method for forming the artificial valve prosthesis with a polymer woven structure comprises the following steps:

[0139] 1. First, the shaped frame 10 is dipped into a solution of the second layer 23, and the solution is processed and solidified to form a uniform second layer 23 on the surface of the frame 10.

[0140] 2. Second, the frame 10 is fitted into a mold corresponding to the shape of the leaflet 20. The mold is in the closed state of the artificial valve, and has a cylindrical structure with multiple concave surfaces matching the shape of the leaflet 20, and a stand between two adjacent concave surfaces to separate the two leaflets 20.

[0141] 3. Then, either (1) or (2) is selected for further operation.

[0142] (1) The polymer woven layer is entirely covered on the frame 10, and the middle part of the polymer woven layer is covered on the concave surfaces of the multiple leaflets 20.

[0143] (2) Alternatively, a longitudinal woven ring is sequentially wound around the multiple separation molds to form a ring of support structure, which is also said to be a longitudinal woven ring matching the structure of the free edge 24 of the leaflet 20 and being fitted around the outer periphery of the multiple feet 11.

[0144] 4. Finally, the mold after the above steps is immersed in the first layer 21 solution, the concave arc surface on the polymer woven layer or the longitudinal woven ring covers the first layer 21 solution, and the first layer 21 is further covered on the partial inner wall and the entire outer wall of the petal frame 10 with the second layer solution film. After the first layer 21 solution is solidified, the excess part is cut by laser, and the final product is taken out, thereby completing the preparation and molding of the implantable artificial valve with the polymer woven structure.

[0145] In one of the embodiments, after the petal frame 10 is molded, a plasma spraying device is used to spray ions on the surface of the petal frame 10 to form a surface ion layer.

[0146] As shown in Figure 11 Further, in one of the embodiments, when the reinforcing layer 22 is a longitudinal woven ring, the reinforcing layer 22 includes a fixed segment 222 sleeved and fixed on the outer periphery of the petal leg 11 and a connecting segment 221 connecting two adjacent fixed segments 222, the connecting segment 221 has the same structure as the free edge of the leaflet 20, and the base layer includes the first layer 21 and the second layer 23; the leaflet 20 further includes a wrapping layer 28 wrapping the outer periphery of the longitudinal woven ring, the wrapping layer 28 cooperates with the outer edges of the first layer 21 and the second layer 23 to wrap the longitudinal woven ring in the base layer, wherein the shape of the wrapping layer 28 is adapted to the shape of the outer periphery of the longitudinal woven ring, that is, the maximum thickness of the wrapping layer 28 in the flow direction of the flow passage is consistent with the overall thickness of the leaflet, the first layer 21 and the second layer 23 are connected to the longitudinal woven ring on the outer periphery of the longitudinal woven ring, and the longitudinal woven ring is wrapped in the base layer. That is, the leaflet 20 with the wrapping layer 28 has an outer periphery shape of the reinforcing layer 22 slightly smaller than the shape of the outer periphery of the wrapping layer 28 connected to the base layer.

[0147] It should be particularly pointed out that when the wrapping layer 28 is wrapped on the outer periphery of the longitudinal woven ring, a corresponding coil groove needs to be provided on the columnar mold for the production and preparation of the corresponding product, and the position of the coil groove provided on the columnar mold corresponds to Figure 3 the position of the longitudinal woven ring, so that the implantable artificial valve molded in the above manner has the second layer 23 solution coated in the coil groove in step 1, and the solution in the coil groove forms a film in the groove after solidification, which serves as the wrapping layer 28. The first layer 21 solution is solidified in step 4 to form an integral body, that is, the wrapping layer 28 is a film on the outer periphery of the longitudinal woven ring, thereby wrapping the coil in the base layer 21.

[0148] More specifically, it can be understood that each leaflet has a reinforcing rib structure near the edge, and the shape and structure of the reinforcing rib are slightly smaller than the base layer, thereby firmly fixing the leaflet 20 on the petal leg 11 of the petal frame 10.

[0149] In this embodiment, the shaped artificial implant valve prosthesis is prepared in such a way that not only the frame 10 and the leaflets 20 are firmly connected as a whole, but also the support reinforcing structure inside adds support strength and fatigue resistance to the leaflets 20, prolonging the service life of the overall structure.

[0150] The leaflets 20 are solidified on the frame 10 from a solution, the surface tension of which and the wetting angle of the frame 10 material are small, thereby achieving good adhesion. Finally, several leaflets 20 and the frame 10 are firmly connected as a whole.

[0151] The above has described various embodiments of the present application, and the above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and changes are obvious to those skilled in the art without departing from the scope and spirit of the described embodiments. The choice of terms used herein is intended to best explain the principles of the embodiments, practical applications, or improvements to the technology in the market, or to enable other ordinary skilled persons in the art to understand the embodiments disclosed herein.

Claims

1. A prosthetic valve for artificial implantation, characterized in that, The valve frame and the valve leaflets formed on the valve frame; The valve frame has valve legs connecting the valve leaflets; The valve leaflets have fixed edges connected to the valve frame and free edges, and the free edges of the valve leaflets can be attached to each other to form a closed state of the artificial valve; The valve leaflets include a base layer and a reinforcing layer, the reinforcing layer is a longitudinal woven ring formed by weaving longitudinal woven strips, the longitudinal woven ring includes a fixed segment fixedly sleeved on the outer periphery of the valve leg and a connecting segment connecting two adjacent fixed segments, and the structure of the connecting segment is the same as that of the free edge of the valve leaflet; It also includes a suture ring, the suture ring is in the form of a cylinder with open ends, and is arranged around the outer periphery of the valve frame, the valve frame has a flow passage, and the suture ring is arranged on the side of the valve frame close to the flow passage, the suture ring has a variable diameter structure in the height direction thereof, the large-diameter end is adjacent to the free end of the valve leg, and the small-diameter end is adjacent to the flow passage of the valve frame.

2. The artificial implant valve prosthesis of claim 1, characterized in that The reinforcing layer has a first layer surface on the side close to the free end of the valve leg, and a second layer surface on the opposite side; The base layer covers the first layer surface of the reinforcing layer.

3. The artificial implant valve prosthesis of claim 1, wherein, The reinforcing layer has a first layer surface on the side close to the free end of the valve leg, and a second layer surface on the opposite side; The base layer covers the second layer surface of the reinforcing layer.

4. The artificial implant valve prosthesis of claim 1, wherein, The reinforcing layer has a first layer surface on the side close to the free end of the valve leg, and a second layer surface on the opposite side; the base layer includes two layers, namely a first sub-layer and a second sub-layer; The first sub-layer covers the first layer surface of the reinforcing layer; The second sub-layer covers the second layer surface of the reinforcing layer, and the edge is attached to the inner wall of the valve frame; The reinforcing layer is sandwiched between the second sub-layer and the first sub-layer.

5. The artificial implant valve prosthesis of claim 4, characterized in that The second sub-layer extends outwardly to cover the entire surface of the valve frame.

6. The artificial implant valve prosthesis according to any one of claims 4 or 5, characterized in that The first sub-layer extends outwardly to cover the reinforcing layer and the entire surface of the valve frame.

7. The artificial implant valve prosthesis of claim 1, wherein, The number of valve legs is three, the number of fixed segments is the same as that of valve legs, and each fixed segment is fixed to a corresponding valve leg.

8. The artificial implant valve prosthesis of claim 7, characterized in that The reinforcing layer has a first layer surface on the side close to the free end of the valve leg, and a second layer surface on the opposite side; the base layer includes a first sub-layer and a second sub-layer; The first sub-layer covers the first layer surface of the reinforcing layer; The second sub-layer covers the second layer surface of the reinforcing layer, and the edge is attached to the inner wall of the valve frame; The reinforcing layer is sandwiched between the second sub-layer and the first sub-layer; The valve leaflet further includes a wrapping layer wrapped around the outer periphery of the woven strip; The inner side of the wrapping layer cooperates with the outer edge of the base layer to wrap the woven strip as a whole; The shape of the wrapping layer is adapted to the shape of the outer periphery of the woven strip.

9. The artificial implant valve prosthesis of claim 1, wherein, The valve frame has a flow passage, in the closed state of the artificial valve formed by the free edges of the valve leaflets being attached to each other, the highest point of the combination of the fixed edge of the valve leaflet and the valve leg forms a top point of the fixed edge, the free edge of the valve leaflet and the free edge of the other valve leaflet form a convergence point, and the included angle between the line connecting the convergence point and the top point of the fixed edge and the plane perpendicular to the flow direction of the flow passage is [15°-25°].

10. The artificial implant valve prosthesis of claim 4, wherein, The valve leaflet has a predetermined thickness; The thickness of the first sub-layer is greater than the thickness of the reinforcing layer. The thickness of the second sub-layer is greater than the thickness of the reinforcing layer.

11. The artificial implant valve prosthesis of claim 10, characterized in that The thickness of the second sub-layer is the same as the thickness of the first sub-layer.

12. The artificial implant valve prosthesis of claim 11, characterized in that The outer peripheral ring of the suture ring towards the free end of the post is provided with a bionic valve lip. The bionic valve lip has an arc-shaped protrusion, the lip edge of the bionic valve lip is matched with the native valve ring structure of the aortic valve, or the lip edge of the bionic valve lip is matched with the native valve ring structure of the mitral valve, and most of the arc-shaped protrusions correspond to the positions of the posts on the valve frame. An installation slot is formed on the inner periphery of the bionic valve lip corresponding to the position of each post. A clearance slot is formed on both sides of the installation slot and communicates with the installation slot, and the radial depth of the clearance slot is less than or equal to the radial depth of the installation slot. The communication position of the clearance slot and the installation slot is close to the top side of the post, and the bottom of the installation slot is higher than the top of the variable-diameter structure. The lowest position of the clearance slot is higher than the variable-diameter structure, or the lowest position of the clearance slot is flush with the top of the variable-diameter structure, and the bottom of the valve frame is flush with the bottom of the suture ring.

13. The artificial implant valve prosthesis of claim 12, characterized in that The maximum height of the bottom of the suture ring to the lower end surface of the bionic valve lip is a first preset length, and the first preset length is within [2mm, 6mm].

14. The artificial implant valve prosthesis of claim 12, wherein, The minimum position of the small-diameter end of the variable-diameter structure is flush with the minimum position of the bionic valve lip close to the flow-through opening direction of the valve frame.

15. The prosthetic valve of any of claims 1-5, 7, 9-14, wherein, The material of the valve frame is PEEK material containing barium sulfate.

16. The prosthetic valve of any of claims 1-5, 7, 9-14, wherein, The side of the flow-through opening of the valve frame is the bottom, a plurality of suture holes are formed on the side wall close to the bottom of the valve frame, and the suture holes are uniformly formed in the circumferential direction of the valve frame.

17. The prosthetic valve of any of claims 1-5, 7, 9-14, wherein, The material of the base layer is pu material.

18. The artificial implant valve prosthesis of any one of claims 1-5, 7, 9-14, wherein, The reinforcing layer is pet high molecular material.

19. The artificial implant valve prosthesis of claim 1, wherein, The reinforcing layer is ptfe material.

20. A method of manufacturing a prosthetic valve for implantation in a human, for manufacturing a prosthetic valve for implantation in a human according to any one of claims 1 to 19, characterized in that, The method comprises the following steps: Injection molding or machining molding the valve frame; Using a plasma device to process the inner and outer surfaces of the valve frame.

21. The method of claim 20, wherein the artificial implant valve prosthesis is prepared by, Before the valve frame is formed, barium sulfate is added to the material for generating the valve frame.

22. The method of claim 20, wherein the artificial implant valve prosthesis is prepared by, The artificial implantation of the valve prosthesis comprises a suture ring. The suture ring is in a tubular structure with both ends open, and is arranged on the outer periphery of the valve frame, the valve frame has a flow-through opening, and the suture ring is arranged on the side close to the flow-through opening of the valve frame. Barium sulfate is added to the material for generating the suture ring.

23. The method of claim 22, wherein the artificial implant valve prosthesis is prepared by, The method comprises the following steps: After the valve frame is formed, a high molecular material is dip-coated on the valve frame to generate the base layer of the valve leaflet; The reinforcing layer of the valve leaflet is laid on the base layer.

24. The method of claim 23, wherein the artificial implant valve prosthesis is prepared by, The method comprises the following steps: a layer of the base layer is further dip-coated on the reinforcing layer.

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