CN219983141U - Artificial implantation valve prosthesis - Google Patents

Abstract

The application relates to a prosthetic implant valve prosthesis, which comprises a valve frame and valve leaves integrally formed with the valve frame; the valve frame is provided with valve feet connected with the valve leaves; the valve leaflet has a fixed edge and a free edge connected to the valve frame, the free edges of the valve leaflet can be mutually attached to form a closed state of the artificial valve; the valve leaflet comprises a base layer and a reinforcing layer; wherein, the enhancement layer is the braided structure, the enhancement layer is connected to on the lamella foot. By adding the reinforcing layer except the base layer on the valve leaflet and connecting the reinforcing layer to the valve foot, when the implanted artificial valve is opened, the reinforcing layer effectively disperses the stress of the valve foot position when the valve is opened, and can assist the valve foot to play an auxiliary supporting role, thereby solving the problem of stress concentration of the valve foot position of the valve frame, reasonably improving the fatigue resistance of the valve frame, effectively improving the opening and closing times of the valve leaflet, prolonging the service life of the valve frame and reasonably reducing the replacement frequency of the artificial valve.

Description

Artificial implantation valve prosthesis

Technical Field

The application relates to the technical field of artificial valves, in particular to an artificial implantation valve prosthesis.

Background

Prosthetic heart valves should ideally last at least ten years in the body. The valve She Ying of the prosthetic heart valve exhibits sufficient durability to be cycled at least 4 hundred million times or more. It is necessary to resist structural degradation, including the formation of holes, cracks, etc., and adverse biological consequences, including calcification and thrombosis.

Prosthetic valves fall into two broad categories depending on the materials used: one is a called polymer valve made of artificial polymer materials, and the other is a called biological valve made of biological tissues.

Biological valve classification: biological valves can be divided into two main categories, heterologous and homologous. Wherein the heterologous valve comprises a porcine aortic valve and a bovine pericardial valve; the homovalve comprises fresh homoaortic valve, autologous fascia lata valve and homodura valve. The biological valve has the advantages that the biological valve does not need to eat anticoagulant for life, but has the defects of limited service life and gradual decline change of the biological valve about 20 years.

With the development of technology, the use rate of the polymer valve tends to be higher and higher, but after long-term use, the material is easy to fatigue, and the thromboembolism rate of an implanter is higher.

In summary, in order to further improve the service life of the prosthetic heart valve, the structural strength of the heart valve needs to be enhanced, so as to reduce the replacement frequency of the prosthetic heart valve in the patient.

Disclosure of Invention

In view of the above, the present utility model provides a prosthetic implant valve prosthesis, comprising a valve frame and valve leaflets formed on the valve frame; the valve frame is provided with valve feet connected with the valve leaves; the valve leaflet has a fixed edge and a free edge connected to the valve frame, the free edges of the valve leaflet can be mutually attached to form a closed state of the artificial valve; the valve leaflet comprises a base layer and a reinforcing layer; wherein the reinforcing layer is connected with the valve foot.

In one possible implementation, one side of the reinforcement layer facing the free end of the valve foot is a first layer surface, and the other opposite side is a second layer surface; the base layer is covered on the first layer surface of the reinforcing layer.

In one possible implementation, one side of the reinforcement layer facing the free end of the valve foot is a first layer surface, and the other opposite side is a second layer surface; the base layer covers the second layer surface of the reinforcing layer.

In one possible implementation, one side of the reinforcement layer facing the free end of the valve foot is a first layer surface, and the other opposite side is a second layer surface; the base layer comprises two layers, namely a first layering and a second layering; the first layering covers a first layer face of the reinforcing layer; the second layer covers the second layer surface of the reinforcing layer, and the edge of the second layer is attached to the inner wall of the valve frame; the reinforcement layer is sandwiched between the second and first layers.

In one possible implementation, the second layer extends outwardly, covering the entire surface of the valve frame.

In one possible implementation, the first layer extends outwardly, covering the reinforcing layer and all of the surface of the valve frame.

In one possible implementation, the reinforcement layer is an elongated braid comprising a fixed section secured to the periphery of the leaflet and a connecting section attached at the free edge of the leaflet.

In one possible implementation, the number of the valve feet is three, and the number of the fixing sections is the same as the number of the valve feet, and the fixing sections are respectively fixed on the corresponding valve feet.

In one possible implementation, one side of the reinforcement layer facing the free end of the valve foot is a first layer surface, and the other opposite side is a second layer surface; the base layer comprises a first layering and a second layering; the first layer covers a first level of the reinforcement layer; the second layer covers the second layer face 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 layered layer and the first layered layer; the valve leaflet also comprises a wrapping layer wrapping the periphery of the longitudinal woven strip; the inner side of the wrapping layer is matched with the outer edge of the base layer, and the longitudinal woven strip is integrally wrapped; wherein the shape of the wrapping layer is matched with the peripheral shape of the longitudinal woven strip.

In one possible implementation manner, the valve frame is provided with a circulation port, in a closed state that free edges of the valve leaves are mutually attached to form a prosthetic valve, the highest point of the combination of the fixed edge of each valve leaf and the valve foot forms a vertex of the fixed edge, the free edge of the valve leaf is attached to the free edge of other valve leaves to form a convergence point, and an included angle formed by a connecting line of the convergence point and the vertex of the fixed edge and a plane perpendicular to the circulation direction of the circulation port is [15 ° -25 ° ].

In one possible implementation, the leaflet has a preset thickness; wherein the thickness of the first layer is greater than the thickness of the reinforcing layer; the thickness of the second layer is greater than the thickness of the reinforcing layer.

In one possible implementation, the second layer is the same thickness as the first layer.

In one possible implementation, a sewing ring is included; the sewing ring is of a cylindrical structure with two open ends, the sewing ring is annularly arranged on the periphery of the valve frame, the valve frame is provided with a circulation port, and the sewing ring is arranged at one side of the valve frame close to the circulation port; the suture ring is provided with a reducing structure in the height direction, the direction adjacent to the free end of the valve foot is a large-diameter end, and the direction adjacent to the flow opening of the valve frame is a small-diameter end; the sewing ring can extend into the aorta in communication with the aortic valve or into the left atrium in communication with the mitral valve.

In one possible implementation, the outer circumferential ring of the side of the sewing ring facing the free end of the valve foot is provided with a bionic valve lip; the bionic valve lip is provided with an arc-shaped bulge, the lip edge of the bionic valve lip is matched with the native valve annulus structure of the aortic valve, or the lip edge of the bionic valve lip is matched with the native valve annulus structure of the mitral valve, and most of the arc-shaped bulge corresponds to the position of the valve foot on the valve frame; the inner circumference of the bionic valve lip is provided with a mounting groove corresponding to each valve foot; the two sides of the mounting groove are provided with a relief groove communicated with the mounting groove, and the depth of the relief groove in the radial direction of the bionic valve lip is smaller than or equal to the depth of the mounting groove in the direction; the communicating position of the abdication groove and the installation groove is at one side close to the top of the petal foot, and the bottom of the installation groove is higher than the reducing structure or is flush with the top of the reducing structure; the lowest position of the relief groove is higher than the reducing structure, or the lowest position of the relief groove is flush with the top of the reducing structure, and the bottom of the valve frame is flush with the bottom of the sewing ring.

In one possible implementation, the maximum height from the bottom of the sewing 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 ].

In one possible implementation, the lowest position of the small diameter end of the reducing structure is kept flush with the lowest position of the bionic valve lip close to the flow opening direction of the valve frame.

In one possible implementation, the material of the petal rack is PEEK material containing barium sulfate.

In one possible implementation, the reinforcement layer is a woven structure.

In one possible implementation manner, one side of the circulation port of the valve frame is the bottom, a plurality of suture holes are formed in 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.

In one possible implementation, the material of the base layer is pu material.

In one possible implementation, the reinforcing layer is a pet polymer material.

In one possible implementation, the reinforcement layer is a ptfe material.

On the other hand, the application also provides a preparation method of the artificial implantation valve prosthesis, which comprises the following steps: injection molding or machining the petal rack; and treating the inner and outer surfaces of the valve frame by using plasma equipment.

In one possible implementation, the method includes the steps of: barium sulfate is added to the material from which the valve frame is formed prior to the valve frame being formed.

In one possible implementation, the method includes the steps of: barium sulfate is added to the material from which the sewing ring is formed.

In one possible implementation, the method includes the steps of: dipping a macromolecular material on the molded valve frame to generate a base layer of the valve leaf; and paving a reinforcing layer of the valve leaflet on the base layer.

In one possible implementation, the method includes the steps of: and dip-coating a base layer on the reinforcing layer.

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

Other features and aspects of the present application will become apparent from the following detailed description of exemplary embodiments, which proceeds with reference to the accompanying drawings.

Drawings

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

FIG. 1 shows a schematic side view of a prosthetic implant valve prosthesis for a mitral valve according to one embodiment of the present application;

FIG. 2 shows a schematic side view of a prosthetic implant valve prosthesis for a mitral valve according to another embodiment of the present application;

FIG. 3 shows a schematic view of a plan view of a prosthetic implant valve prosthesis for a mitral valve according to another embodiment of the present application;

FIG. 4 illustrates a schematic side view of a prosthetic implant valve prosthesis adapted for use with a active valve in accordance with one embodiment of the present application;

FIG. 5 shows a schematic cross-sectional view of a prosthetic implant valve prosthesis adapted for use with a valve in accordance with one embodiment of the present application;

FIG. 6 illustrates a schematic perspective view of a sewing ring suitable for use with an active valve in accordance with an embodiment of the present application;

FIG. 7 shows a schematic perspective view of a sewing ring for a mitral valve according to an embodiment of the present application;

FIG. 8 illustrates a schematic partial cross-sectional view of a multi-layered structure of a leaflet in accordance with an embodiment of the present application;

FIG. 9 shows a schematic side view of a prosthetic implant valve prosthesis for a mitral valve in accordance with one embodiment of the present application;

FIG. 10 shows a schematic structural view of a leaflet-bearing valve frame in accordance with an embodiment of the present application;

figure 11 shows a schematic partial cross-section of a leaflet with a wrapping layer in accordance with an embodiment of the present application.

Detailed Description

Various exemplary embodiments, features and aspects of the application will be described in detail below with reference to the drawings. In the drawings, like reference numbers indicate identical or functionally similar elements. Although various aspects of the embodiments are illustrated in the accompanying drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

It should be understood, however, that the terms "center," "longitudinal," "transverse," "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counter-clockwise," "axial," "radial," "circumferential," and the like indicate or are based on the orientation or positional relationship shown in the drawings, and are merely for convenience of describing the application or simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the application.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present application, the meaning of "a plurality" is two or more, unless explicitly defined otherwise.

The word "exemplary" is used herein to mean "serving as an example, embodiment, or illustration. Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

In addition, numerous specific details are set forth in the following description in order to provide a better illustration of the application. It will be understood by those skilled in the art that the present application may be practiced without some of these specific details. In some instances, well known methods, procedures, components, and circuits have not been described in detail so as not to obscure the present application.

FIG. 1 shows a schematic side view of a prosthetic implant valve prosthesis for a mitral valve according to one embodiment of the present application; FIG. 2 shows a schematic side view of a prosthetic implant valve prosthesis for a mitral valve according to another embodiment of the present application; FIG. 3 shows a schematic view of a plan view of a prosthetic implant valve prosthesis for a mitral valve according to another embodiment of the present application; FIG. 4 illustrates a schematic side view of a prosthetic implant valve prosthesis adapted for use with a active valve in accordance with one embodiment of the present application; FIG. 5 shows a schematic cross-sectional view of a prosthetic implant valve prosthesis adapted for use with a valve in accordance with one embodiment of the present application; FIG. 6 illustrates a schematic perspective view of a sewing ring suitable for use with an active valve in accordance with an embodiment of the present application; FIG. 7 shows a schematic perspective view of a sewing ring for a mitral valve according to an embodiment of the present application; figure 8 illustrates a partial cross-sectional schematic view of a flap She Sanceng structure in accordance with an embodiment of the application; FIG. 9 shows a schematic side view of a prosthetic implant valve prosthesis for a mitral valve in accordance with one embodiment of the present application; FIG. 10 shows a schematic structural view of a leaflet-bearing valve frame in accordance with an embodiment of the present application; figure 11 shows a schematic partial cross-section of a leaflet with a wrapping layer in accordance with an embodiment of the present application.

As shown in fig. 1, 2 and 8, a prosthetic implant valve prosthesis comprises a valve frame 10 and valve leaflets 20 integrally formed with the valve frame 10; the valve frame 10 has valve feet 11 connected to the valve leaflets 20; the leaflet 20 has a fixed edge 25 and a free edge 24 that are attached to the frame 10, the free edges 24 of the leaflet 20 being attachable to each other to form a closed state of the prosthetic valve; the leaflet 20 includes a base layer 21 and a reinforcing layer 22; wherein the reinforcing layer 22 is a woven structure, and the reinforcing layer 22 is connected to the valve foot 11.

In this embodiment, in addition to the base layer 21 in the valve leaflet 20, a reinforcing layer 22 is further added on the valve leaflet 20, and the edge of the reinforcing layer 22 can be connected to the valve foot 11, when the artificial valve is implanted in the application, the position of the valve corner 11 is used as a main stress point, so that stress concentration is easy to occur, the stress of the position of the valve foot 11 when the valve is opened is dispersed due to the arrangement of the reinforcing layer 22, and the valve foot 11 can be assisted to play a better supporting role, so that the problem of stress concentration at the position of the valve foot 11 of the valve frame 10 is solved, thereby reasonably improving the fatigue resistance of the valve frame 10, effectively improving the opening and closing times of the valve leaflet 20, realizing the prolongation of the service life of the artificial valve, and reducing the replacement frequency of the artificial implanted valve.

As shown in fig. 8 and 10, in one particular embodiment, the prosthetic implant valve prosthesis comprises: the valve frame 10 and a plurality of valve leaves 20 integrally formed on the inner side of the valve frame 10, the valve frame 10 is provided with a plurality of valve legs 11 and a circulation port, each valve leaf 20 is arranged between two adjacent valve legs 11, each valve leaf 20 is provided with a fixed edge 25 and a free edge 24 which are connected to the valve frame 10, the highest point of the combination of the fixed edge 25 of the valve leaf 20 and the valve leg 11 forms an apex 27 of the fixed edge 25, and the free edges 24 of the valve leaves 20 can be mutually attached to form a closed state of the artificial valve.

Further, the leaflet 20 has a multi-layered structure including a reinforcing layer 22 and a base layer 21. The reinforcing layer 22 is a layer of polymer material woven layer with edges connected to the valve foot 11, or is a longitudinal woven ring, the corresponding position of the reinforcing layer 22 is annularly fixed on the periphery of the valve foot 11, the rest part of the reinforcing layer is the same as the free edge 24 of the valve blade 20 in structure, namely the longitudinal woven ring comprises a fixing section 222 sleeved and fixed on the periphery of the valve foot 11 and a connecting section 221 connected with the two adjacent fixing sections 222, and the structure of the connecting section 221 is the same as the free edge structure of the valve blade 20; the side of the reinforcing layer 22 facing the free end of the valve foot 11 is a first layer surface 223, and the side facing the flow opening is a second layer surface 224; the base layer 21 covers at least the first layer face 223 of the reinforcing layer 22.

It should be emphasized that the reinforcement layer 22 may be a woven layer structure with an overall layer, or a longitudinal woven ring structure matched with the outer contour of the leaflet 22 is provided on the outer contour of the leaflet 22, as shown in fig. 2 and 3, that is, the reinforcement layer 22 under the longitudinal woven ring structure is hollow except for one ring of "reinforcing ribs" matched with the outer contour, and the woven structure is usually woven by using a polymer material.

It should be noted that, the flowing direction refers to the direction of the blood flowing through the flowing port, in this embodiment, the blood flowing direction is substantially identical to the extending direction of the valve foot 11, if shown in the drawing, please refer to fig. 1, the up-down direction in fig. 1 is the direction of the blood flowing through the flowing port, the free end of the valve foot 11 of the valve frame 10 is the top, and the flowing port direction of the valve frame 10 is the bottom; in fig. 2, the horizontal plane perpendicular to the up-down direction is the plane perpendicular to the flow direction of the flow port. The petal 11 according to the present application is: the valve foot 11 has a main supporting function when the valve leaves 20 are opened due to the supporting structure protruding from the annular part of the valve frame 10 towards one side, the free ends of the valve foot 11 are opposite to the opening direction of the circulation opening on the valve frame 10, and the free ends of the valve foot 11 are arc-shaped, so that the damage to the heart caused by artificial implants such as the valve frame 10 can be reduced as far as possible.

In one embodiment, the reinforcing layer 22 is a woven structure.

In one embodiment, as shown in fig. 3, the reinforcement layer 22 is a lengthwise woven loop, and includes a fixing section 222 sleeved and fixed on the periphery of the valve foot 11, and a connecting section 221 connecting two adjacent fixing sections 222, where the structure of the connecting section 221 is the same as the free edge 24 of the valve leaflet 20.

In one embodiment, as shown in fig. 8, the side of the reinforcing layer 22 facing the free end of the valve foot 11 is a first layer surface 223, and the side facing the flow port is a second layer surface 224; the base layer comprises a first sub-layer 21, the first sub-layer 21 covering at least a first layer face 223 of the reinforcement layer 22.

In this embodiment, the reinforcement layer 22 is covered on the first layer 223 of the reinforcement layer 22 to effectively avoid stress concentration at the position of the petal 11, and compared with the technical scheme that the reinforcement layer 22 is sandwiched between the first layer 21 and the second layer 23, this embodiment has the advantages of simple structure, easier production and preparation, and low cost.

In one embodiment, as shown in fig. 1, when the reinforcement layer 22 is a polymer braid, the edges of the polymer braid are secured to the valve foot 11 of the valve frame 10.

In one embodiment, as shown in fig. 3, the reinforcement layer 22 is an elongated braided loop that includes a fixed segment 222 secured to the outer periphery of the leaflet 11 and a connecting segment 221 attached to the free edge of the leaflet 20.

In this embodiment, the lengthwise knit loop may be: the longitudinal braiding rings are formed by connecting a plurality of braiding wires, the fixing sections 222 of the longitudinal braiding rings are fixedly arranged on the periphery of the valve foot, the connecting sections 221 are connected with the two adjacent fixing sections 222, and the outer contour structure of the connecting sections 221 can be consistent with the free edge structure of the valve leaflet 20, or the outer contour structure of the connecting sections 221 can be slightly smaller than the free edge structure of the valve leaflet 20.

The connection points of the multi-section braided wires are usually between the fixed section 222 and the connection section 221, and during molding, one end of the fixed section 222 is slightly inclined towards the top direction, the connection section 221 adjacent to the fixed section 222 is slightly inclined towards the bottom direction, and the connection points of the fixed section 222 and the connection section 221 are mutually overlapped, so that the contact area of the connection positions is increased, and the structural strength of the connection point positions is effectively enhanced.

In one embodiment, the number of the valve feet 11 is three, and the number of the fixing sections 222 is the same as the number of the valve feet 11, and the fixing sections are respectively fixed to the corresponding valve feet 11.

As shown in fig. 3, in one embodiment, the number of the valve legs 11 on the valve frame 10 is three, and the reinforcement layer 22 is a longitudinal knitting ring disposed at Xiang Dengjiao degrees around the valve frame 10, the longitudinal knitting ring is in a preset shape, and is sleeved and fixed on the valve legs 11 of the valve frame 10, and the projection of the longitudinal knitting ring in the circulation direction of the circulation port is approximately: the three sharp corners of the fan blade shape are respectively corresponding to the positions of the longitudinal braiding rings in the peripheral direction of the valve foot, the positions of the three sharp corners of the fan blade shape divide the rest of the longitudinal braiding rings into three sections of connecting lines, and the shape formed by each section of connecting line is consistent with the structure of the free edge of the valve blade.

The first layer 223 is arranged on the side of the reinforcement layer 22 facing the free end of the valve foot 11, the second layer 224 is arranged on the side facing the flow opening, the base layer 21 at least covers the first layer 223 of the reinforcement layer 22, the base layer 21 extends outwards and covers the first layer 223 of the reinforcement layer 22.

In this embodiment, the leaflet 20 divided into a multi-layer structure comprises a reinforcing layer 22 and at least a free end covering the reinforcing layer 22 toward the leaflet 11, the leaflet 11 is disposed on the leaflet frame 10, the free end of the leaflet 11 is disposed in a direction opposite to a direction in which a flow opening on the leaflet frame 10 is opened,

in this embodiment, the arrangement of the reinforcing layer 22 in the base layer adds a layer of reinforcing rib structure to the valve leaflet 20, effectively improves the opening and closing times of the valve leaflet 20, prolongs the service life of the valve leaflet, reasonably reduces the replacement frequency of the artificial implantation valve prosthesis, and further, the edge of the reinforcing layer 22 is fixed on the valve foot 11, enhances the integration of the valve frame 10 and the valve leaflet 20, and when the artificial implantation valve prosthesis is opened, the reinforcing layer 22 can assist the valve foot 11 to support, and when the valve is opened, the stress at the position of the valve foot 11 is dispersed, thereby solving the problem of stress concentration at the position of the valve foot 11 of the valve frame 10, and reasonably improving the fatigue resistance of the valve frame 10.

Further, by integrally forming the plurality of valve leaflets 20 on the inner side of the valve frame 10, the free edges 24 of the valve leaflets 20 can be opened to a preset position or closed to cover the circulation opening in the valve frame 10, and the stress of the plurality of valve leaflets 20 formed integrally is more uniform and has better consistency, so that the valve leaflets 20 with corresponding shapes can be formed only by setting the die during integral forming, and the shape controllability of the valve leaflets 20 is improved.

As shown in fig. 8 and 11, in one embodiment, when the leaflet 20 has a three-layer structure, the base layer includes a first layer 21 and a second layer 23, the flow opening of the leaflet frame 10 is a bottom, the leaflet 11 extends from the bottom to the top, the first layer 21 covers the first layer 223 of the reinforcing layer 22, the middle of the second layer 23 covers the second layer 224 of the reinforcing layer 22, and the edge is attached to the inner wall of the leaflet frame 10, and the reinforcing layer 22 is sandwiched between the second layer 23 and the first layer 21.

In this embodiment, the base layer includes a first layer 21 and a second layer 23, the first layer 21 is adhered to the first layer 223 of the reinforcing layer 22 and covers the first layer 223 of the reinforcing layer 22, in addition, the middle of the second layer 23 is adhered to the bottom of the reinforcing layer 22 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 after molding and higher structural strength than the two-layer structure only covering the first layer 223 of the reinforcing layer 22, and the first layer 21 and the second layer 22 wrap the reinforcing layer 22 from the first layer 223 and the second layer 224 of the reinforcing layer 22, so that the leaflet 20 and the leaflet frame 10 have better fusion property after molding, more specifically, the three-layer structure is easier to realize because the leaflet 20 itself has thinner thickness, the thickness of the reinforcing layer 22 located inside is thinner, and the leaflet has the highest molding rate than the two-layer or more-layer structure.

It should be noted that the reinforcing layer 22 is usually a fiber layer woven in advance on a weaving machine, or is a fiber woven wire, and has a thickness of about 0.05 mm.

In one embodiment, the leaflet 20 is a double layer structure, the edge of the reinforcing layer 22 is secured to the leaflet 11, and the first layer 21 is covered on the first layer 223 of the reinforcing layer 22.

In one embodiment, the first layer 21 extends outwardly covering the reinforcing layer 22 and the surface of the entire valve frame 10, and the second layer 23 extends outwardly covering the surface of the entire valve frame 10.

In this embodiment, the second layer 23 formed on the valve frame 10 extends outwards and is coated on the surface of the valve frame 10, and the forming method may be: the valve frame 10 is placed in a solution of a base material, and then is processed, so that the second layered layer 23 forms a layer of film covering the surface of the valve frame 10, after the film is cooled and solidified, the reinforcing layer 22 is arranged on the valve foot 11 of the valve frame 10, the second layered layer 23 is covered on the valve frame 10, the first layered layer 21 is covered on the reinforcing layer 22 more easily, the reinforcing layer 22 is wrapped in the middle of the second layered layer 23 and the first layered layer 21 to form a sandwich structure, the valve frame 20 is ensured to have a reinforcing structure, and meanwhile, the valve leaves 20 are firmly connected to the valve frame 10, so that the valve frame has better bonding strength.

In one embodiment, the first layer 21 extends outwardly, covering the reinforcement layer 22 and the surface of the valve frame 10.

In this embodiment, the first layer 21, which is applied to the first layer 223 of the reinforcing layer 22, is formed by: the reinforcement layer 22 formed on the valve frame 10 or the valve frame 10 formed on the valve frame 10 and the reinforcement layer 22 and the second layer 23 are immersed in the solution of the first layer 21, namely, the first layer 21 covers at least part of the inner side surface of the valve foot 11 and the outer side surface of the valve frame 10 except the first layer 223 of the reinforcement layer 22, so that the valve leaflet 20 is tightly connected with the valve frame 10.

In one embodiment, as shown in fig. 1, when the reinforcement layer 22 is a polymer braid, the middle of the polymer braid is a partially spherical structure slightly smaller than the first layered layer 21, and the edge of the polymer braid at the position of the valve foot 11 is wrapped around the free end of the valve foot 11.

In this embodiment, when the valve leaflet 20 is opened and closed, the acting force of the valve leaflet 20 is mainly applied to the free end position of the valve leaflet 11, and the polymer braiding layer is only arranged to cover the free end of the valve leaflet 11, so that when the valve leaflet 20 acts, the effect of assisting the valve leaflet 11 to support the whole structure is achieved, the cost is reduced, the condition of stress concentration is effectively avoided, and when the polymer braiding layer covers the rest part of the valve frame 10, the restraint and the fastening degree of the valve frame are too high, the whole toughness of the valve frame 10 is affected, the opening and closing range of the valve leaflet 20 is reduced, and the opening and closing actions of the artificial implanted valve prosthesis after implantation are not facilitated.

In one embodiment, the second layer 23 is the same material as the first layer 21.

In this embodiment, the second layer 23 and the first layer 21 made of the same material can better connect the contact positions of the two layers, and compared with the connection between different materials, the compatibility of the same material is better, and the stability and consistency of the leaflets 20 on the valve frame 10 are improved by using the second layer 23 and the first layer 21 made of the same material and forming the plurality of leaflets 20 on the valve frame 10.

In addition, the artificial implantation valve prosthesis does not use any metal parts and animal tissues, and platelets are not easy to attach to the valve frame 10 or the valve leaflet 20, so that anticoagulation is not needed, and the harmful body medicaments such as antibiotics and the like are avoided from being taken by patients for the whole life.

In one embodiment, the first layer 21 and the second layer 23 are the same material.

In one embodiment, the first and second layers 21 and 23 are pu.

Preferably, the materials of the second layer 23 and the first layer 21 are polyurethane.

In one embodiment, the material of the reinforcing layer 22 is pet polymer material or ptfe material.

Preferably, when the reinforcing layer 22 is a polymer woven layer, the reinforcing layer 22 is made of pet polymer.

Preferably, when the reinforcing layer 22 is an elongated knitted loop, it is made of pt fe.

In one embodiment, the leaflet 20 is partially spherical when the leaflet 20 is in the closed position, and the convex direction of the spherical structure is toward the side of the free end distal from the leaflet 11.

In this embodiment, the leaflets 20 are each of a partially spherical configuration, and each leaflet 20 is of identical configuration, preferably with a radius of the arc of the leaflet 20 within [20mm,40mm ].

In one embodiment, as shown in fig. 9 and 10, in a closed state in which the free edges 24 of the leaflets 20 can be attached to each other to form a prosthetic valve, the free edge 24 of each leaflet 20 is attached to the free edge 24 of the other leaflet 20 to form a converging point 26, and an included angle α formed by a line connecting the converging point 26 and the vertex 27 of the fixed edge 25 and a plane perpendicular to the flow direction of the flow orifice is in a range of 15 ° -25 °.

In this embodiment, the convergence point 26 at the lowest position, i.e. the position of the leaflet 20 at this point 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, so as to ensure that the plurality of leaflets 20 can completely cover the flow orifice in cooperation, effectively close, and the structure of the leaflet 20 is more reasonable, so that the opening and closing positions of the leaflets 20 have a shorter displacement amount, thereby facilitating the increase of the working efficiency and the extension of the service life of the surgical implantation prosthetic valve of the application.

More specifically, the flow opening is an opening in the inner side of the valve frame 10, more than two valve legs 11 are arranged at intervals on the edge of the valve frame 10, the number of the valve leaves 20 is more than two, the valve frames are provided with fixed edges 25 connected to the inner side of the valve frame 10 and free edges 24 moving between an open position and a closed position in the valve frame 10, the valve leaves 20 are arranged between the two adjacent valve legs 11, when the valve leaves 20 are in a closed state, an included angle alpha formed by a connecting line of an converging point 26 of the free edges 24 to an apex 27 of the fixed edges 25 and a plane perpendicular to the flow direction of the flow opening is 15-25 degrees, as shown in fig. 3, namely, an included angle alpha formed by a connecting line between the highest point of the free edges 24 of the valve leaves 20 and the apex 27 of the fixed edges 25 of the valve leaves 20 and a flowing direction perpendicular to the flow opening is 15-25 degrees.

In this embodiment, by connecting the fixed edge 25 of the leaflet 20 to the inner side of the valve frame 10, the free edge 24 of the leaflet 20 can be opened to a preset position in the valve frame 10, or close to cover the circulation opening, the leaflet 20 is generally in a cambered surface structure, each leaflet 20 is arranged between two adjacent leaflets 11, the plurality of leaflets 20 integrally formed on the valve frame 10 are in a structure, the stress of the plurality of leaflets 20 is more uniform, the uniformity is better, and the integrally formed leaflets 20 can form the leaflets 20 with corresponding shapes by corresponding dies, only setting the dies in the integral forming process, thereby improving the controllability of the shapes of the leaflets 20, and besides, the straight line connecting the vertex 27 of the fixed edge 25 of the leaflet 20 with the convergence point 26 of the free edge 24 of the leaflet 20 at the lowest position in the closed state forms an included angle [15 °,25 ° ] with the plane perpendicular to the circulation opening, namely, the two vertexes 27 of the fixed edge 25 of the leaflet 20 between two adjacent leaflets 11 and the convergence point 26 at the lowest position define the three-point convergence point 20, and the overall structure is further defined; in summary, the valve leaflet 20 integrally formed on the valve frame 10 is combined with the three end points with included angles within the range of 15 ° -25 ° described above to obtain the valve leaflet 20 with better cambered surface and better overall structure arranged on the valve frame 10 in the application, and has the advantage of larger flow opening area during opening and closing actions, and further reduces the difference value of the valve-crossing differential pressure at two sides of the heart valve on the premise of solving the valve stenosis index, and establishes similar hemodynamics and blood flow rate as those of the heart valve of human beings.

It should be further specifically noted that the heights of the two fixed edge vertices 27 of each leaflet 20 may be identical or slightly different, as long as the included angle α between the line connecting the two fixed edge vertices 26 of the free edge 24 and the plane perpendicular to the flow opening is within [15 °,25 ° ].

In one embodiment, as shown in fig. 8, the leaflet 20 has a predetermined thickness in the flow direction perpendicular to the flow opening, 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.

In one embodiment, second layer 23 is the same thickness as first layer 21.

In the above two embodiments, the thickness of the whole leaflet 20 is uniform, and the thicknesses of the second layer 23 and the first layer 21 are both greater than the thickness of the reinforcing layer 22, and the thicknesses of the first layer 21 and the second layer 23 may be the same or different, and are not limited herein.

As shown in fig. 5-7, in one embodiment, the suture ring 30 is comprised of a suture ring 30, the suture ring 30 having a cylindrical structure with two open ends, and being disposed around the lower peripheral portion of the valve frame 10.

In this embodiment, the valve frame 10 is typically sewn to the sewing ring 30 and ultimately to the aortic or mitral valve of the human body, which once sewn in place will change the dynamic aortic valve ring into a fixed configuration.

As shown in FIG. 4, in one embodiment, the sewing ring 30 has a reducing structure 33 in its radial direction, a large diameter end 32 adjacent to the free end of the valve foot 11 and a small diameter end 34 adjacent to the flow opening of the valve frame 10, and the sewing ring 30 can extend into the aorta communicating with the aortic valve or into the left atrium communicating with the mitral valve.

In this embodiment, the suture ring 30 has a reducing structure 33 in its radial direction, the reducing structure 33 is usually located at the middle of the suture ring 30 with a tubular structure, the large diameter end 32 is the end of the suture ring 30 near the direction of the free end of the valve foot 11, the small diameter end is the end of the suture ring 30 near the direction of the circulation port, the small diameter end 34 of the suture ring 30 with the reducing structure 33 is more easy to extend into the aorta communicating with the aortic valve, or the small diameter end 34 of the suture ring 30 extends into the left atrium communicating with the mitral valve, i.e. the suture ring 30 with the reducing structure 33 is tubular, so that it can borrow space between the aorta and the left atrium, make full use of the space communicating between the ventricles and the atrium, and reduce the space occupied in the atrium.

More specifically, when the implanted artificial valve with the polymer woven structure of the application extends into the aorta, the distance from the other end of the valve frame 10 to the left ventricle can be further reduced on the premise of not blocking the blood flow of the coronary artery at the side of the aorta by adopting the reducing suture ring 30 because the borrowing depth of the implanted artificial valve in the aorta is shallower, so that the occupied space of the implanted artificial valve in the left ventricle is reduced, and the damage of the artificial implanted valve to the heart is reduced.

As shown in FIG. 9, in one embodiment, the sewing ring 30 has a first predetermined length b in its axial extension into the aorta or left atrium, the first predetermined length b being within 2mm,6 mm.

In this embodiment, the length of the first preset length b at [2mm,6mm ] means: the sewing ring 30 borrows distance from the left ventricle or left atrium in its axial direction.

The overall height of the valve frame 10 from bottom to top is within [11mm,19mm ].

As shown in fig. 4-6, in one embodiment, a bionic valve lip 31 is disposed on the outer circumferential ring of the suture ring 30 facing the free end of the valve foot 11, the bionic valve lip 31 has an arc protrusion 311, the lip edge of the bionic valve lip 31 is adapted to the native annulus structure of the aortic valve or the native annulus structure of the mitral valve, and most of the arc protrusions 311 correspond to the disposition position of the valve foot 11 on the valve frame 10.

In this embodiment, a bionic valve lip 31 is disposed on the outer circumferential ring of the suture ring 30 facing the free end of the valve foot 11, and the bionic valve lip 31 is in a ring-shaped structure and has undulation in the circumferential direction thereof to form a plurality of arc-shaped protrusions 311.

As shown in fig. 6, when the bionic valve lip 31 is matched with the native valve annulus structure of the aortic valve, three arc-shaped protrusions 311 are provided on the bionic valve lip 31, the three arc-shaped protrusions 311 are uniformly distributed on the bionic valve lip 31, and an included angle formed by two adjacent arc-shaped protrusions 311 and the connecting line of the ring center of the bionic valve lip 31 is 120 degrees, and the middle point of the arc-shaped protrusions 311 coincides with the middle point of the three valve feet 11 on the corresponding valve frame 10 in the axial direction.

As shown in fig. 7, when the bionic valve lip 31 is matched with the native annulus structure of the mitral valve, the bionic valve lip 31 has two arc-shaped protrusions 311, the two arc-shaped protrusions 311 divide the circumference into 120 ° and 240 °, and the number of the valve feet 11 of the valve frame 10 is three, wherein the middle points of the two valve feet 11 in the axial direction thereof coincide with the middle points of the two arc-shaped protrusions 311 on the bionic valve lip 31.

In one embodiment, as shown in fig. 4, the diameter-varying structure 33 is positioned flush with the lowest position of the bionic valve lip 31.

In this embodiment, the lowest position of the bionic valve lip 31 is located near the bottom side of the valve frame 10, i.e. the lowest position of the reducing structure 33 is the lowest point of the arc-shaped protrusion, specifically, the lowest position of the reducing structure 33 is flush with the top of the small diameter end 34.

As shown in fig. 6, in one embodiment, a mounting groove 312 is formed in the inner circumferential direction of the bionic valve lip 31 at a position corresponding to each valve foot 11.

In this embodiment, the inner circumference of the bionic valve lip 31 is provided with a mounting groove 312, the mounting groove 312 is provided from top to bottom, the structure of the mounting groove 312 is matched with the structure of the valve foot 11 on the valve foot 11, and is a trapezoid-like groove structure with short top and long bottom, the provision of the mounting groove 312 effectively reduces the radial thickness of the bionic valve lip 31, and reduces the influence of the reduction of the maximum openable area of the implanted prosthetic valve prosthesis caused by the too thick bionic valve lip 31.

As shown in fig. 6, in one embodiment, the mounting groove 312 is provided with a relief groove 313 respectively on two sides of the inner circumference of the bionic valve lip 31, and the depth of the relief groove 313 in the radial direction of the bionic valve lip is smaller than or equal to the depth of the mounting groove 312 in the direction.

In one embodiment, the communication position between the relief groove 313 and the mounting groove 312 is on the side close to the top of the petal 11, and the bottom of the mounting groove 312 is higher than the diameter-changing structure 33 or is flush with the top of the diameter-changing structure 33; the lowermost position of the relief groove 313 is higher than the reducing structure 33 or is flush with the top of the reducing structure 33.

In the above embodiment, the mounting groove 312 is provided with the relief groove 313 which is mutually communicated with the two sides of the mounting groove 312 on the two sides of the inner circumference of the bionic valve lip 31, and the thickness of the bionic valve lip 31 is reduced by the arrangement of the relief groove 313, so that the overall circumferential flexibility of the sewing ring 30 is effectively improved, and when the artificial valve prosthesis is implanted to open or close, the sewing ring 30 with insufficient flexibility is avoided, so that the problems of small opening area of the valve leaflet 20, low service life of the artificial valve prosthesis are solved.

In one embodiment, as shown in fig. 5, a plurality of suture holes 12 are formed in a sidewall of the valve frame 10 near the bottom, the suture holes 12 are uniformly formed in the circumferential direction of the valve frame 10, and the bottom of the valve frame 10 is flush with the bottom of the suture ring 30.

In this embodiment, the side wall of the valve frame 10 near the bottom is uniformly provided with a plurality of suture holes 12 in the circumferential direction, the suture holes 12 are positioned at the bottom of the suture ring 30, the suture ring 30 is wrapped in the circumferential direction of the valve frame 10, and the suture ring 30 and the valve frame 10 are sewn to the corresponding positions of the designated mitral valve and aortic valve through suture needles.

In one embodiment, as shown in fig. 9, the maximum length of the valve frame 10 extending into the left ventricle is a second preset length c, which is within 8mm,16 mm.

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

In one embodiment, the melting point of the valve frame 10 is lower than the melting point of the leaflet 20.

In this embodiment, the melting point of the valve leaflet 10 is lower than the melting point of the valve leaflet 20 so that when the valve leaflet 10 is immersed in the solution of the first layer 21 or the second layer 23, the molded valve leaflet 10 itself does not melt together, resulting in failure of molding.

In one embodiment, the valve frame 10 is made of PEEK containing barium sulfate.

In this embodiment, the material of the petal rack 10 is PEEK material containing barium sulfate, the barium sulfate is insoluble in water and acid, has stable chemical property, no magnetic toxicity, and has a natural mineral capable of absorbing X-rays and gamma rays, and the petal rack 10 with a certain linear property is formed by mixing a certain content of barium sulfate with the PEEK powder through an injection molding process.

In one particular embodiment, the surface of the valve frame 10 is coated with ions.

In this embodiment, the petal rack 10 is subjected to modification treatment, namely plasma treatment on the surface of the petal rack 10, so as to enhance the development effect; the plasma treatment improves the wettability of the solution of the valve frame 10 and the valve leaflet 20 and improves the bonding force of the valve frame 10 and the valve leaflet 20; the barium sulfate developing effect can improve the ct developing during or after operation and is not influenced by detection such as nuclear magnetic resonance. The uniform spray treatment is performed on the outer surface and the inner surface of the valve frame 10 by a plasma spray device: firstly, the surface roughness of the valve frame 10 is improved by plasma treatment, the bonding area with the solution is increased, and therefore the adhesive force of the valve leaves 20 on the valve frame 10 is improved; in addition, after the PEEK material is subjected to plasma treatment, polar groups such as hydroxyl, amino, carboxyl and the like are introduced into the surface of the PEEK material, so that the adhesive force between the PEEK material petal rack 10 and the solution is increased, and the adhesive strength is improved.

On the other hand, the application also provides a preparation method of the artificial implantation valve prosthesis, which comprises the following steps: injection molding or machining the petal rack; and treating the inner and outer surfaces of the valve frame by using plasma equipment.

In one embodiment, the method comprises the following steps: barium sulfate is added to the material from which the valve frame is formed prior to the valve frame being formed.

In one embodiment, the method comprises the following steps: barium sulfate is added to the material from which the sewing ring is formed.

In one embodiment, the method comprises the following steps: dipping a polymer material on the molded valve frame 10 to generate a base layer 21 of the valve leaflet 20; a reinforcing layer 22 of the leaflet 20 is laid over the base layer 21.

In one embodiment, the method comprises the following steps: a base layer 21 is dip-coated on the reinforcing layer 22.

More specifically, the manufacturing method has a first mold for manufacturing the valve frame 10 and a second mold for molding the valve leaflet 20 on the valve frame 10; preparing and molding the petal holder 10 using a first mold; sleeving and fixing the valve frame 10 on a second die, and forming the valve leaves 20 on the valve frame 10; wherein, the base layer 21 and the reinforcing layer 22 are formed on the valve frame 10 layer by layer from the flow opening of the valve frame 10 to the valve foot 11.

In summary, by the above preparation method, more specifically, the method for forming the implanted prosthetic valve prosthesis with the polymer braid structure of the present application comprises:

1. firstly, immersing the prepared and molded valve frame 10 into a solution of a second layering 23, and after the solution is solidified, coating a uniform layer of the second layering 23 on the surface of the valve frame 10;

2. next, the valve frame 10 is sleeved on a mold corresponding to the molding of the valve blade 20. (the second mold is a mold in a closed state of the artificial valve, in particular a cylinder structure, the middle part of the cylinder is provided with a plurality of concave cambered surfaces matched with the structures of the valve leaflets 20, and the upright posts with two sharp ends and wide middle parts are arranged in front of the two adjacent concave cambered surfaces to be used as separating molds of the two adjacent valve leaflets 20)

3. Then, carrying out subsequent operation by selecting one of the steps (1) and (2);

(1) The polymer braiding layer is integrally covered on the valve frame 10, and the middle part of the polymer braiding layer is covered on the concave cambered surfaces of the valve leaflets 20 and matched with the concave cambered surfaces.

(2) Alternatively, the longitudinal braid is sequentially wound around the plurality of separate molds to form a single-turn support structure, or alternatively, a single-turn longitudinal braid is formed to be matched with the free edge 24 structure of the leaflet 20 and to be fitted around the outer circumferences of the plurality of leaflets 11.

4. Finally, the whole die which is subjected to the steps is immersed into the solution of the first layering 21, the solution of the first layering 21 is covered on a macromolecule weaving layer or a concave cambered surface on a lengthwise weaving ring, the first layering 21 is covered on part of the inner wall and all the outer walls of the valve frame 10 with the second layer of solution film, after the solution of the first layering 21 is solidified, the superfluous part is subjected to laser cutting, and finally a finished product is taken out, so that the preparation and the molding of the implanted artificial valve with the macromolecule weaving structure can be finished.

In one embodiment, after the valve frame 10 is formed, ions are sprayed on the surface of the valve frame 10 using a plasma spraying device to form a surface ion layer.

As shown in fig. 11, in one embodiment, when the reinforcement layer 22 is a lengthwise woven loop, the reinforcement layer includes a fixing section 222 sleeved and fixed on the outer circumference of the valve foot 11 and a connecting section 221 connecting two adjacent fixing sections 222, the structure of the connecting section 221 is the same as the free edge structure of the valve leaflet 20, and the base layer includes a first layer 21 and a second layer 23; the valve leaflet 20 further comprises a wrapping layer 28 wrapping the outer peripheral side of the longitudinal braiding ring, the wrapping layer 28 is matched with the outer edges of the first layered layer 21 and the second layered layer 23 to wrap the longitudinal braiding ring in the base layer integrally, wherein the shape of the wrapping layer 28 is matched with the outer peripheral shape of the longitudinal braiding ring, that is, the maximum thickness of the wrapping layer 28 in the circulation direction of the circulation port is consistent with the integral thickness of the valve leaflet, and the first layered layer and the second layered layer are connected into a whole on the outer peripheral side of the longitudinal braiding ring and wrap the longitudinal braiding ring inside. That is, the leaflet 20 with the wrapping 28 has a reinforcing layer 22 therein that has a peripheral shape that is slightly smaller than the peripheral shape of the wrapping 28 attached to the base layer.

It should be noted that, when the outer peripheral side of the lengthwise braiding ring is coated with the wrapping layer 28, the corresponding coil groove is formed on the cylinder mold, the coil groove is formed at the opening position of the cylinder mold corresponding to the schematic position of the lengthwise braiding ring in fig. 3, the thus formed implanted prosthetic valve is also coated with the solution of the corresponding second layer 23 in the coil groove in the above step 1, the solution in the coil groove is solidified to form a film in the groove, and as the wrapping layer 28, the first layer 21 is solidified to form a whole body from the outer periphery of the lengthwise braiding ring in cooperation with the solution of the first layer 21 in step 4, i.e. the wrapping layer 28 is a film layer in the outer periphery of the lengthwise braiding ring, thereby wrapping the whole coil inside the whole base layer 21.

More specifically, it will be appreciated that each leaflet has a ring of reinforcing ribs at the proximal edge which are slightly smaller in shape and configuration than the base layer to firmly secure the leaflet 20 to the leaflet legs 11 of the frame 10.

In this embodiment, the molded prosthetic implant valve prosthesis is prepared in such a way that not only the valve frame 10 is firmly connected to the valve leaflet 20 as a whole, but also the support reinforcement structure therein increases the support strength and fatigue resistance of the valve leaflet 20, and prolongs the service life of the overall structure.

The valve leaflet 20 is solidified on the valve frame 10 from the solution, and the tension of the surface of the solution is small in wetting angle with the material of the valve frame 10, so that good adhesion is realized. Eventually, the plurality of leaflets 20 are firmly connected to the valve frame 10 as a unit.

The foregoing description of embodiments of the application has been presented for purposes of illustration and description, and is not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the various embodiments described. The terminology used herein was chosen in order to best explain the principles of the embodiments, the practical application, or the improvement of technology in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

Claims (22)

1. A prosthetic implant valve prosthesis, which is characterized by comprising a valve frame and valve leaves molded on the valve frame;

the valve frame is provided with valve feet connected with the valve leaves;

the valve leaflet has a fixed edge and a free edge connected to the valve frame, the free edges of the valve leaflet can be mutually attached to form a closed state of the artificial valve;

the valve leaflet comprises a base layer and a reinforcing layer;

Wherein the reinforcing layer is connected with the valve foot.

2. The prosthetic implant valve prosthesis of claim 1, wherein one side of the reinforcement layer facing the free end of the valve foot is a first layer and the opposite side is a second layer;

the base layer is covered on the first layer surface of the reinforcing layer.

3. The prosthetic implant valve prosthesis of claim 1, wherein one side of the reinforcement layer facing the free end of the valve foot is a first layer and the opposite side is a second layer;

the base layer covers the second layer surface of the reinforcing layer.

4. The prosthetic implant valve prosthesis of claim 1, wherein one side of the reinforcement layer facing the free end of the valve foot is a first layer and the opposite side is a second layer; the base layer comprises two layers, namely a first layering and a second layering;

the first layering covers a first layer face of the reinforcing layer;

the second layer covers the second layer surface of the reinforcing layer, and the edge of the second layer is attached to the inner wall of the valve frame;

the reinforcement layer is sandwiched between the second and first layers.

5. The prosthetic implanted valve prosthesis of claim 4, wherein the second layer extends outwardly, covering the entire surface of the valve frame.

6. The prosthetic implant of any one of claims 4 or 5, wherein the first layer extends outwardly, covering the reinforcement layer and the entire surface of the valve frame.

7. The prosthetic implant of claim 1, wherein the reinforcement layer is an elongated braid comprising a fixation section secured to the periphery of the leaflet and a connection section attached at the free edge of the leaflet.

8. The prosthetic implant valve prosthesis of claim 7, wherein the number of valve legs is three, the number of securing segments being the same as the number of valve legs, each secured to a corresponding valve leg.

9. The prosthetic implant valve prosthesis of claim 7 or 8, wherein the reinforcement layer has a first layer on one side toward the free end of the valve foot and a second layer on the opposite side; the base layer comprises a first layering and a second layering;

the first layer covers a first level of the reinforcement layer;

the second layer covers the second layer face 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 layered layer and the first layered layer;

The leaflet also comprises a wrapping layer wrapping the periphery of the longitudinal braid;

the inner side of the wrapping layer is matched with the outer edge of the base layer, and the longitudinal woven strip is integrally wrapped;

wherein the shape of the wrapping layer is matched with the peripheral shape of the longitudinal woven strip.

10. The prosthetic implant of claim 1, wherein the valve frame has a flow opening, and wherein in a closed state in which the free edges of the leaflets abut against each other to form a prosthetic valve, the highest point at which the fixed edges of the leaflets join the valve legs forms an apex of the fixed edges, and the free edges of the leaflets abut against the free edges of the other leaflets to form a converging point, and an angle formed by a line connecting the converging point and the apex of the fixed edges and a plane perpendicular to the flow direction of the flow opening is [15 ° -25 ° ].

11. The prosthetic implanted valve prosthesis of claim 4, wherein the leaflet has a preset thickness;

wherein the thickness of the first layer is greater than the thickness of the reinforcing layer;

the thickness of the second layer is greater than the thickness of the reinforcing layer.

12. The prosthetic implant valve prosthesis of claim 11, wherein the second layer is the same thickness as the first layer.

13. The prosthetic implant valve prosthesis of claim 1, comprising a sewing ring;

the sewing ring is of a cylindrical structure with two open ends, the sewing ring is annularly arranged on the periphery of the valve frame, the valve frame is provided with a circulation port, and the sewing ring is arranged at one side of the valve frame close to the circulation port;

the suture ring is provided with a reducing structure in the height direction, the direction adjacent to the free end of the valve foot is a large-diameter end, and the direction adjacent to the flow opening of the valve frame is a small-diameter end.

14. The prosthetic implant valve prosthesis of claim 13, wherein the outer circumferential ring of the suture ring on the side facing the free end of the valve foot is provided with a bionic valve lip;

the bionic valve lip is provided with an arc-shaped bulge, the lip edge of the bionic valve lip is matched with the native valve annulus structure of the aortic valve, or the lip edge of the bionic valve lip is matched with the native valve annulus structure of the mitral valve, and most of the arc-shaped bulge corresponds to the position of the valve foot on the valve frame;

the inner circumference of the bionic valve lip is provided with a mounting groove corresponding to each valve foot;

the two sides of the mounting groove are provided with a relief groove communicated with the mounting groove, and the depth of the relief groove in the radial direction of the bionic valve lip is smaller than or equal to the depth of the mounting groove in the direction;

The communicating position of the abdication groove and the installation groove is at one side close to the top of the petal foot, and the bottom of the installation groove is higher than the reducing structure or is flush with the top of the reducing structure;

the lowest position of the relief groove is higher than the reducing structure, or the lowest position of the relief groove is flush with the top of the reducing structure, and the bottom of the valve frame is flush with the bottom of the sewing ring.

15. The prosthetic implant valve prosthesis of claim 14, wherein the maximum height of the suture ring from the bottom of the suture ring to the lower end surface of the simulated valve lip is a first preset length, the first preset length being within [2mm,6mm ].

16. The prosthetic implant valve prosthesis of claim 14, wherein the minor diameter end lowest position of the reducing structure is flush with the lowest position of the simulated valve lips in the direction of the valve frame flow opening.

17. The prosthetic implant of any one of claims 1-5, 7, 8, 10-16, wherein the valve frame is a PEEK material containing barium sulfate.

18. The prosthetic implant valve prosthesis of any one of claims 1-5, 7, 8, 10-16, wherein the reinforcement layer is a braided structure.

19. The prosthetic implant of any one of claims 1-5, 7, 8, 10-16, wherein the flow port side of the valve frame is a bottom, a plurality of suture holes are formed in a sidewall of the valve frame adjacent to the bottom, and the suture holes are uniformly formed in the circumferential direction of the valve frame.

20. The prosthetic implant valve prosthesis of any one of claims 1-5, 7, 8, 10-16, wherein the base layer is pu.

21. The prosthetic implant of any one of claims 1-5, 7, 8, 10-16, wherein the reinforcement layer is pet polymer.

22. The prosthetic implanted valve prosthesis of claim 7, wherein the reinforcement layer is of ptfe material.