CN115105261A

CN115105261A - Surgically implanted prosthetic valve

Info

Publication number: CN115105261A
Application number: CN202210697642.6A
Authority: CN
Inventors: 张红魁; 王松
Original assignee: Shanghai Yixin Medical Devices Co ltd
Current assignee: Shanghai Yixin Medical Devices Co ltd
Priority date: 2022-06-20
Filing date: 2022-06-20
Publication date: 2022-09-27

Abstract

The application relates to a surgical implantation artificial valve, which comprises a valve frame and a plurality of valve leaflets integrally formed on the inner side of the valve frame, wherein the valve frame is provided with a plurality of supporting parts and circulating ports, and the valve leaflets are provided with fixed edges and free edges connected to the valve frame; the valve blades are arranged between two adjacent supporting parts, the highest point of the combination of the fixed edge of each valve blade and the supporting part forms the top point of the fixed edge, the free edges of the valve blades can be mutually attached to form the closed state of the artificial valve, the free edges of the valve blades are all attached to the free edges of other valve blades to form a convergence point in the closed state, and the included angle formed by the connecting line of the convergence point and the top point of the fixed edge and the plane vertical to the flow direction of the flow opening is (15-25 degrees). The integrally-made valve leaflet is combined with three endpoints with included angles of [15 degrees and 25 degrees ], so that the valve leaflet with a better cambered surface and an integral structure in the application is obtained, the area of a flow opening is larger, the difference value of the trans-valve pressure difference at two sides of the heart valve is reduced, and hemodynamics and blood flow volume similar to those of the human heart valve are established.

Description

Surgically implanted prosthetic valve

Technical Field

The application relates to the technical field of medical equipment, in particular to a surgical implantation artificial valve.

Background

Prosthetic heart valves ideally should last at least ten years in vivo. To last that long, prosthetic heart valves should exhibit sufficient durability to cycle at least 4 hundred million times or more. The valves, and more particularly the heart valve leaflets, must resist structural degradation including the formation of holes, tears, etc., and adverse biological consequences including calcification and thrombosis.

The trans-valve pressure difference is the difference of blood pressure on both sides of the heart valve and is an index for measuring valve stenosis.

For the bovine pericardium artificial heart valve structure, most of valve leaflets are formed by cutting through a plane and then sewn on a valve frame, the radian of the valve leaflets fixed in the mode cannot be controlled, so that the problem that the cross-valve pressure difference is high due to the small area of a flow opening of an implanted valve is caused.

Disclosure of Invention

In view of the above, the present application provides a surgically implantable prosthetic valve, which includes a valve frame and a plurality of valve leaflets integrally formed inside the valve frame; the valve frame is provided with a plurality of supporting parts and circulation ports; each leaflet has a fixed edge connected to the leaflet frame and a free edge; each valve leaf is arranged between two adjacent supporting parts, the highest point of the combination of the fixed edge of each valve leaf and the supporting part forms the top point of the fixed edge, the free edges of each valve leaf can be mutually attached to form the closed state of the artificial valve, in the closed state, the free edge of each valve leaf is attached to the free edges of other valve leaves to form a convergence point, and the included angle formed by the connecting line of the convergence point and the top point of the fixed edge and the plane vertical to the flow direction of the flow opening is [ 15-25 degrees ].

In a possible implementation manner, the valve frame is made of PEEK.

In one possible implementation, the maximum length of the flap holder in the flow direction of the flow opening is a first predetermined height, which is within [11mm, 19mm ].

In a possible implementation manner, the flow opening of the flap frame is a bottom portion, and the support portion extends from the bottom portion to the top portion; the valve frame is perpendicular to the flowing direction of the flowing port and is provided with a preset thickness, and the preset thickness is gradually reduced from the bottom to the top of the valve frame.

In one possible implementation, the preset thickness of the flap frame is within [0.3mm-1mm ].

In a possible implementation manner, the number of the supporting parts is three, and the supporting parts are arranged at equal intervals.

In one possible implementation, the height of the convergence point is lower than the height of the vertex of the fixed edge.

In one possible implementation, each of the leaflets is a partially spherical structure.

In one possible implementation, the radius of the arc of each leaflet is within [20mm-40mm ].

In one possible implementation, the outer surface of the valve frame is coated with a connecting layer connected to the valve leaflets.

In a possible implementation manner, a plurality of fixing edges of the valve leaflets are connected to the connecting layer on one side of the inner wall of the valve frame, and the valve leaflets are made of the same material as the connecting layer; the valve frame is provided with a plurality of valve leaves, and one side of each valve leaf close to a free edge can cover the circulation port of the valve frame.

In one possible implementation manner, the melting point of the material of each leaflet is lower than the melting point of the material of the leaflet frame.

In one possible implementation, the leaflet is made of a TPU composite material.

In one possible implementation, a sewing ring is included, which is disposed at a lower portion of the valve frame.

In one possible implementation, the sewing ring is of an annular structure and has a plurality of arc-shaped protrusions thereon.

In a possible implementation manner, the number of the arc-shaped protrusions on the sewing ring is three, and the arc-shaped protrusions are uniformly distributed on the sewing ring, and the positions of the arc-shaped protrusions are consistent with the positions of the supporting parts.

In one possible implementation, the sewing ring is covered with fabric at least at the position of contact with the valve frame; the sewing ring is provided with a hole for a sewing needle to pass through.

In one possible implementation, a flap skirt is included, which is disposed on the sewing ring and around the outside of the flap frame.

In one possible implementation, the suture ring comprises a valve skirt, wherein the valve skirt is arranged on the suture ring and is annularly arranged on the outer side of the valve frame; the material of the valve skirt is the same as that of the valve leaflets, and the valve skirt and the valve leaflets are integrally formed on the valve frame.

In one possible implementation, the connecting layer is integrally formed on the outer surface of the valve frame.

The beneficial effect of this application: the valve leaflets are integrally formed on the valve frame, so that the valve leaflets with corresponding shapes can be formed only by setting a mould during integral forming, the controllability of the shapes of the valve leaflets is improved, and not only are the vertex of the fixed edge of the valve leaflet and the vertex of the converging point of the free edge of the valve leaflet at the lowest position in a closed state and the included angle formed by the straight line perpendicular to the plane of the flow opening be [15 degrees and 25 degrees ], namely the two vertexes of the fixed edge of the valve leaflet and the converging point at the lowest position between two adjacent supporting parts, the three endpoints further limit the shapes of the valve leaflets, and the integral structures of the valve leaflets are determined; in summary, the valve leaflet integrally formed on the valve frame is combined with the three end points of the included angle in the interval of [15 degrees and 25 degrees ] described above, so that the valve leaflet with a more optimal arc surface and a more optimal integral structure arranged on the valve frame is obtained, and the difference value of the trans-valve pressure difference at two sides of the heart valve is reduced on the premise of solving the valve stenosis index during opening and closing actions.

More specifically, when the flow opening is opened to the maximum, the valve leaflet has a larger flow opening after being opened due to the structural advantages, the flow is further increased, the difference value of the trans-valve pressure difference on two sides of the heart valve can be reduced, and the hemodynamics and the blood flow similar to those of the human heart valve are established.

In addition, the valve does not use any metal parts and animal tissues, platelets are not easy to attach to the valve frame or the valve, anticoagulation is not needed, and the problem that a patient takes antibiotics and other body-harmful medicines for the life is avoided.

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 the 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 perspective view of a surgical mitral valve with a skirt according to an embodiment of the present application;

FIG. 2 shows a schematic elevational view of a surgical mitral valve with a skirt according to an embodiment of the present application;

FIG. 3 shows a schematic view of a surgical mitral valve with a skirt at an angle α according to an embodiment of the present application;

FIG. 4 illustrates a perspective view of a surgical mitral valve without a skirt according to an embodiment of the present application;

FIG. 5 illustrates a schematic front view of a surgical mitral valve without a skirt according to an embodiment of the present application;

FIG. 6 illustrates a perspective view of a surgical aortic valve with a skirt according to an embodiment of the present application;

FIG. 7 illustrates a front view of a surgical aortic valve with a skirt according to an embodiment of the present application;

FIG. 8 illustrates a perspective view of a surgical aortic valve without a skirt according to an embodiment of the present application;

fig. 9 illustrates a front view of a surgical aortic valve without a skirt according to an embodiment of the present application.

Fig. 10 shows a schematic perspective view of a valve frame of a surgical aortic valve according to an embodiment of the present application;

fig. 11 shows a schematic structural view of a frame and leaflets of a surgical mitral valve according to an embodiment of the present application.

Detailed Description

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

It will be understood, however, that the terms "central," "longitudinal," "lateral," "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in an orientation or positional relationship indicated in the drawings for convenience in describing the present application or for simplicity of description, and do not indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be considered limiting of the present application.

The term "distal" refers to an end that is proximal to a target tissue in a patient. The term "proximal" refers to the end that is proximal to the medical practitioner.

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

The word "exemplary" is used exclusively 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.

Furthermore, in the following detailed description, numerous specific details are set forth in order to provide a better understanding of the present 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, methods, means, elements and circuits that are well known to those skilled in the art have not been described in detail so as not to obscure the present application.

FIG. 2 shows a schematic elevational view of a surgical mitral valve with a skirt according to an embodiment of the present application; FIG. 3 shows a schematic view of an angle α assumed by a surgical mitral valve with a valve skirt according to an embodiment of the present application; FIG. 4 illustrates a perspective view of a surgical mitral valve without a skirt according to an embodiment of the present application; FIG. 5 illustrates a schematic front view of a surgical mitral valve without a skirt according to an embodiment of the present application; FIG. 6 illustrates a perspective view of a surgical aortic valve with a skirt according to an embodiment of the present application; FIG. 7 illustrates a front view of a surgical aortic valve with a skirt according to an embodiment of the present application; FIG. 8 illustrates a perspective view of a surgical aortic valve without a skirt according to an embodiment of the present application; fig. 9 illustrates a front view of a surgical aortic valve without a skirt according to an embodiment of the present application. Fig. 10 shows a schematic perspective view of a valve frame of a surgical aortic valve according to an embodiment of the present application; fig. 11 shows a schematic structural view of a frame and leaflets of a surgical mitral valve according to an embodiment of the present application.

As shown in fig. 1-11, the surgically implanted artificial valve includes 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 support portions 11 and a flow opening 13, each valve leaflet 20 has a fixed edge 22 and a free edge 21 connected to the valve frame 10; each valve leaf 20 is arranged between two adjacent supporting parts 11, the highest point of the combination of the fixed edge 22 of each valve leaf 20 and the supporting part 11 forms the peak 24 of the fixed edge, the free edges 21 of each valve leaf 20 can be mutually attached to form the closed state of the artificial valve, in the closed state, the free edges 21 of each valve leaf 20 are attached to the free edges of other valve leaves 20 to form a convergence point 23, and the connecting line of the convergence point 23 and the peak 24 of the fixed edge forms an included angle of [ 15-25 degrees ] with the plane vertical to the flow direction of the flow opening 13.

More specifically, the flow opening 13 is an opening in the inner side 12 of the valve frame, the edge of the valve frame 10 is provided with more than two support parts 11 at intervals, the valve leaflets 20 are multiple, the valve leaflets 20 are provided with fixed edges 22 connected to the inner side of the valve frame 10 and free edges 21 moving between an opening position and a closing position in the valve frame 10, the valve leaflets 20 are arranged between two adjacent support parts 11, when the valve leaflets 20 are in a closing state, a connecting line between a converging point 23 of the free edges 21 and a vertex 24 of the fixed edges 22 forms an included angle alpha of 15-25 degrees with a plane vertical to the flow direction of the flow opening 13, as shown in fig. 3, namely, a connecting line between the highest point 21 of the valve leaflets 20 and the vertex 24 of the fixed edges 22 of the valve leaflets 20 forms an included angle of 15-25 degrees with the flow direction vertical to the flow direction in the flow opening 13. It should be noted that the flow direction refers to a direction of blood flowing through the flow port 13, in this embodiment, the flow direction is substantially the same as the extending direction of the support portion, and if it is shown in the figure, please refer to fig. 2, and the vertical direction in fig. 2 is the direction of blood flowing through the flow port 13; a horizontal plane perpendicular to the up-down direction in fig. 2 is the plane perpendicular to the flow direction of the flow port 13.

In this embodiment, by connecting the fixed edge 22 of the leaflet 20 to the inner side of the valve frame 10, the free edge 21 of the leaflet 20 can be opened to a predetermined position in the valve frame 10 or close to cover the flow opening, the leaflet 20 is usually in a curved structure, each leaflet 20 is disposed between two adjacent support portions 11, a plurality of leaflet 20 structures are integrally formed on the valve frame 10, the plurality of leaflets 20 are stressed more uniformly and have better consistency, and the integrally formed leaflet 20 passes through a corresponding mold, and the mold during the integral forming can be used for forming the leaflet with a corresponding shape only by setting the mold during the integral forming, so as to improve the controllability of the shape of the leaflet, and not only is the straight line connecting the fixed edge vertex 24 of the leaflet 20 and the converging point 23 of the leaflet 21 of the leaflet at the lowest position in the closed state, and the included angle [15 °, 25 ° ] with the plane perpendicular to the flow opening, that is the two vertices 24 of the leaflet fixed edge 22 between two adjacent support portions 11 and the converging point 23 at the lowest position The shape of the valve leaflet is further limited by the three end points, and the integral structure of the valve leaflet is determined; in summary, the valve leaflet 20 integrally formed on the valve frame 10 is combined with the three end points of the above-described interval of 15 ° to 25 ° to obtain the valve leaflet 20 with a better arc surface and a better integral structure arranged on the valve frame 10 in the present application, which has the advantage of a larger flow opening area during the opening and closing actions, and further reduces the difference value of the trans-valve pressure difference on the two sides of the heart valve on the premise of solving the valve stenosis index, and establishes hemodynamics and blood flow volume similar to those of the human heart valve.

In addition, the valve does not use any metal parts and animal tissues, platelets are not easy to attach to the valve frame or the valve, anticoagulation is not needed, and the patient is prevented from taking harmful body medicines such as antibiotics for the life.

It should be further noted that the heights of the vertexes 24 of the two fixed edges 22 of each leaflet 20 may be completely the same or different, and slightly different, only the connection line of the convergence point 23 of the free edge 21 and the plane perpendicular to the flow-through opening is ensured to form an included angle α within [15 ° and 25 ° ].

Preferably, the positions of the vertexes 24 of the two fixed edges 22 of the valve leaflets 20 are completely the same, so that the stress of the artificial valve implanted in the shell is more uniform during the opening and closing actions, and the opening and closing consistency of the valve leaflets 20 is higher.

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

In this embodiment, the valve frame 10 is made of medical PEEK, and the valve frame 10 made of this material has good supporting force and flexibility, so that it can be ensured that the designed lower height of the valve frame 10 can also achieve sufficient structural strength during preparation.

In one embodiment, the valve frame 10 has a first predetermined height, which is within [12mm, 19mm ].

In this embodiment, the highest height of the valve frame 10 in the bottom-to-top direction, i.e. the height of a straight line from the annular bottom to the highest point of the support portion in the blood flow direction, is a first preset height, i.e. the highest height of the support portion 11 of the valve frame 10 is between [12mm, 19mm ].

More specifically, the highest height of the valve frame 10 made of medical grade PEEK is within [12mm, 19mm ], the valve frame 10 has the advantages of low height and small gram weight, and on the premise of having enough structural strength, the valve frame 10 with lower height can effectively reduce the overall damage to the heart.

In one embodiment, the valve frame 10 is formed by enclosing a tapered sheet material, wherein the thickness of the sheet material of the valve frame 10 gradually decreases from the bottom to the top.

In this embodiment, the valve frame 10 of the present application is a tapered sheet structure, that is, the valve frame 10 made of PEEK material is a sheet structure as a whole, and is not a rod-shaped structure formed by processing a metal wire or the like, the direction from bottom to top referred to in the present application is the opening direction of the support portion 11 on the valve frame 10, that is, the side wall of the annular base of the valve frame 10 is thicker, and the wall thickness finally to the top of the support portion 11 is gradually reduced from bottom to top, and the cross section of the valve frame 10 along the blood flowing direction is a tapered structure.

In one embodiment, the thickness of the flap frame 10 enclosed in a sheet shape is within 0.3mm to 1 mm.

In this embodiment, the flap frame 10 is formed as a sheet-like enclosure having a sheet-like structure tapering from a low thickness to a top thickness, the minimum thickness to the maximum thickness being within 0.3mm-1 mm.

In one embodiment, the number of the supporting portions 11 is three, and the supporting portions are arranged at equal intervals.

In this embodiment, the three support portions 11 are uniformly arranged on the circular base of the flap frame 10, that is, an included angle formed by connecting lines between two adjacent support portions 11 and the center of the flap frame 10 is 120 °.

In one embodiment, the converging point 23 of the free edge 21 of the lowest leaflet 20 is lower than the apex 24 of the fixed edge of the leaflet 20.

In this embodiment, the converging point 23 at the lowest position is the position of the leaflet 20 at this point when the leaflet 20 is closed, and the converging point of the free edge of the leaflet 20 is lower than the vertex 24 of the fixed edge, so that the plurality of leaflets 20 can be matched to completely cover the circulation port, the effective closing is realized, the structure of the leaflet 20 is more reasonable, and the opening and closing position of the leaflet 20 has a shorter displacement, so that the working efficiency of the surgically implanted artificial valve of the present application is increased and the service life of the surgically implanted artificial valve is prolonged.

In one embodiment, the leaflet 20 is a partially spherical structure.

In one embodiment, the radius of the arc of the leaflet 20 is within [20mm-40mm ].

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

In one embodiment, the outer surface of the valve frame 10 is coated with a tie layer that is attached to the valve leaflets 20.

In this embodiment, after the valve frame 10 is molded and before the valve leaflets 20 are molded on the valve frame 10, the outer surface of the valve frame 10 is coated with a connecting layer, typically a material for placing the valve frame 10 in a molten state, and after cooling, the outer surface of the valve frame 10 is formed with the connecting layer described herein, which facilitates better connection between the valve frame 10 and the valve leaflets 20.

In one embodiment, the fixing edges 22 of the leaflets 20 are connected to the connecting layer on the inner wall side of the valve frame 10, and the material of the leaflets 20 is the same as that of the connecting layer; the leaflets 20 cover the flow openings of the valve frame 10 on the side close to the free edge 21.

In this embodiment, it is preferable that the material of the connecting layer on the surface of the valve frame 10 is the same as that of the valve leaflet 20, and since the valve frame 10 and the valve leaflet 20 are made of heterogeneous materials, the connecting layer made of the same material as that of the valve leaflet 20 improves the stability and consistency of the valve leaflet 20 on the valve frame 10. More specifically, the attachment of the attachment layer to the leaflet 20 is the fixation edge 22 of the leaflet 20.

In one embodiment, the leaflet 20 has a uniform thickness, and the leaflet 20 has a thickness within 0.09mm, 0.15 mm.

In this embodiment, the thickness of the valve leaflet 20 is even, preferably, the valve leaflet 20 made of the TPU composite material has the same structural design, the same overall quality, the same tissue and the same thickness at each position, and the valve leaflet 20 with the even thickness can ensure that the flow opening area is larger when the valve leaflet is opened, so as to further reduce the pressure difference across the valve.

In one embodiment, the fixed edges 22 of the leaflets 20 partially cover the inner wall of the valve frame 10, and the free edges 21 of the leaflets 20 can cover the flow openings of the valve frame 10.

In one embodiment, the leaflet 20 is formed of a TPU composite material.

It should be noted here that, firstly, a valve frame 10 made of PEEK material is prepared, and is sleeved on a mold for producing the valve leaflet 20;

the mold for preparing the valve leaflets 20 is provided with a base, a limiting bulge for positioning the valve frame 10 is arranged in the middle of the base, a plurality of concave arc surfaces higher than the limiting bulge are arranged in the limiting bulge, the concave arc surfaces are matched with the valve leaflets 20 in structure, and intervals are formed among the structures of the plurality of concave arc surfaces to prevent the valve leaflets 20 from being adhered to each other;

the valve leaflet 20 made of the TPU composite material is heated and then cast into a mold, and after the valve leaflet 20 is cooled and formed, the fixing edge 22 of the valve leaflet 20 covers part of the inner side wall of the valve frame 10.

In one embodiment, the leaflet 20 has a material with a melting point lower than that of the frame 10.

In the above embodiment, the fixing edges 22 of the leaflets 20 are cast onto the valve frame 10 by heating to coat part of the inner wall of the valve frame 10, so that the leaflets 20 are reasonably and effectively connected with the valve frame 10 more tightly, and the plurality of leaflets 20 have higher consistency in operation by the integrally forming manner, and can better cooperate with each other to complete the opening and closing operations. It should be noted that, in the surgically implanted artificial valve processed in this way, the melting point of the material of the leaflet 20 is lower than that of the valve frame 10, so as to ensure that the leaflet 20 in the liquid state after being heated is still in the solid state when contacting the valve frame 10.

In one embodiment, a sewing ring 40 is included, the sewing ring 40 being disposed on the lower portion of the valve frame 10.

In this embodiment, the valve frame 10 is typically sewn to the sewing ring 40 and ultimately to the aortic or mitral valve of the body, which, once in place, changes the dynamic aortic annulus to a fixed configuration.

In one embodiment, the sewing ring 40 is a circular ring-shaped structure.

In this embodiment, the annular sewing ring 40 is a surgical mitral valve adapted to fit the mitral valve.

In one embodiment, sewing ring 40 is an annular structure, and sewing ring 40 has a plurality of arcuate projections 41 thereon.

In this embodiment, the sewing ring 40, which is an annular structure having a plurality of arcuate projections 41 thereon, is a surgical aortic valve adapted to fit the aortic valve.

In one embodiment, the number of the arc-shaped protrusions 41 on the sewing ring 40 is three, and the arc-shaped protrusions 41 are uniformly distributed on the sewing ring 40, and the positions of the arc-shaped protrusions 41 are consistent with the positions of the supporting parts 11.

In this embodiment, the suture ring 40 having the arc-shaped protrusions 41 has the same number of the arc-shaped protrusions 41 as the number of the support portions 11, and the arrangement positions of the arc-shaped protrusions 41 correspond to the arrangement positions of the support portions 11, that is, the support portions 11 are arranged at positions directly above the arc-shaped protrusions 41.

In one embodiment, the sewing ring 40 is covered with fabric at least at the location where it contacts the valve frame 10.

In one embodiment, the sewing ring 40 defines a hole for a needle to pass through.

In this embodiment, the suture ring 40 is pre-formed with suture holes at equal intervals on the suture ring 40, which can help the surgeon suture the valve in place more easily, and is easy to operate and reduces the error rate in the operation.

In one embodiment, the sewing ring 40 is a silicone material.

In this embodiment, the sewing ring 40 can be made of a material different from the material of the valve frame 10 and the valve leaflet 20, so as to provide different overall characteristics, and preferably, the sewing ring 40 is made of silicone. The sewing ring 40 made of silicone material may be directly passed through the sewing ring 40 by a sewing needle without having a sewing hole formed in advance.

In one embodiment, the suture further comprises a valve skirt 30, wherein the valve skirt 30 is arranged on the suture ring 40 and the ring is arranged on the outer side of the valve frame 10.

In this embodiment, add lamella skirt 30 on suture ring 40, and lamella skirt 30 encircles the outside of establishing at lamella frame 10, this structure has reduced the risk that the valve leaks all around, and further, the spatial structure of suture ring 40 position has been increased in the setting of lamella skirt 30, has reduced the practitioner in this field in the operation, has used the suture needle to wear the possibility of wrong position, and more specifically, suture ring 40 is in lamella skirt 30 coverage, restricts the unsuitable puncture position of suture needle periphery through lamella skirt 30, blocks the suture needle, reduces the fault rate of puncturing, provides convenience for the art person, and reasonable, efficient improvement surgery efficiency.

In one embodiment, the skirt 30 has a second predetermined height in the flow direction of the flow-through opening, and the second predetermined height is within [3mm, 10mm ].

In this embodiment, the height of the valve skirt 30 on the sewing ring 40 is kept consistent, and for a surgical mitral valve, the height of the valve skirt 30 on one circle of the sewing ring 40 is kept the same on the annular sewing ring 40 with the arc-shaped protrusions 41, which is defined as a second preset height, preferably, the second preset height is within [3mm, 10mm ].

In one embodiment, the suture needle further comprises a valve skirt 30, the valve skirt 30 is arranged on the suture ring 40 and is annularly arranged on the outer side of the valve frame 10, the material of the valve skirt 30 is the same as that of the valve leaflet 20, and the valve skirt 30 and the valve leaflet 20 are integrally formed on the valve frame 10.

In this embodiment, the skirt 30 and the leaflet 20 may be made of the same material, that is, they may be made of TPU composite material, and they are fused and cast onto the valve frame 10 sleeved on the corresponding manufacturing mold in a molten state, so that the stress of the leaflet 20 in the surgically implanted artificial valve of the present application may be more uniform and consistent, thereby improving the consistency of the closure of the leaflet 20.

Furthermore, when the valve skirt 30 and the valve leaflet 20 are made of different materials, even if the same material is used, the two-step separate molding can be performed, for example, the valve frame for preparing the molding is sleeved in a mold for producing the valve leaflet and/or the valve frame, a plurality of valve leaflets 20 are integrally molded on the valve frame 10, after that, the subsequent preparation of the valve skirt 30 is performed, the mold for the valve skirt 30 can be the same mold for producing the valve leaflet 20, or a separate mold specially used for preparing the valve skirt 30, where it is only necessary to clearly separate the valve skirt 30 from the valve leaflet 20 and separately mold the valve skirt 30 on the valve frame 10, the valve skirt 30 is arranged outside the valve frame 10, the valve leaflets 20 are arranged inside the valve frame 10, the two have no conflict, and whether the two are connected has no direct influence on the closing of the valve leaflet 20 in the present application, furthermore, even if the same material is used, the valve skirt 30 and the valve leaflet 20 are integrally molded on the valve frame 10, it can also be carried out in two steps.

It is also specifically noted that the surgically implanted prosthetic valves of the present application do not use any metal parts and animal tissue, and platelets do not readily adhere to the valve frame 10 or the valve, and therefore anticoagulation is not required.

In one embodiment, the connecting layer is integrally formed on the outer surface of the valve frame 10.

Preferably, the connecting layer (the connecting layer is entirely covered on the outer side of the valve frame 10, so no reference numeral in the figure), the valve leaflets 20 and the valve skirt 30 are all made of the same TPU composite material, and the connecting layer is used as a thin film layer covered on the outer side of the valve frame 10, so that the same material is adopted by one side of the inner wall of the valve frame 10 and the valve leaflets 20, and the connection is firmer; and the connecting layer that is located petal frame 10 outer wall one side adopts the same material with petal skirt 30, connects more stably, and the reliability is high.

Having described embodiments of the present application, the foregoing description is intended to be exemplary, not exhaustive, and not limited to the disclosed embodiments. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen in order to best explain the principles of the embodiments, the practical application, or improvements made to the technology in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

1. A surgical implantation artificial valve is characterized by comprising a valve frame and a plurality of valve leaflets which are integrally formed on the inner side of the valve frame;

the valve frame is provided with a plurality of supporting parts and circulation ports;

each leaflet has a fixed edge connected to the leaflet frame and a free edge;

each valve leaf is arranged between two adjacent supporting parts, the highest point of the combination of the fixed edge of each valve leaf and the supporting part forms the top point of the fixed edge, the free edges of each valve leaf can be mutually jointed to form the closed state of the artificial valve, in the closed state, the free edge of each valve leaf is jointed with the free edges of other valve leaves to form a convergence point, and the included angle formed by the connecting line of the convergence point and the top point of the fixed edge and the plane vertical to the flow direction of the flow opening is (15-25 degrees).

2. The surgically implanted prosthetic valve of claim 1, wherein the valve frame is constructed of PEEK.

3. The surgically implantable prosthetic valve of claim 1, wherein a maximum length of the valve frame in a flow direction of the flow port is a first predetermined height, the first predetermined height being within [11mm, 19mm ].

4. The surgically implantable prosthetic valve of claim 1, wherein the flow port of the valve frame is a bottom portion, and the support portion extends from the bottom portion in a top direction;

the valve frame is perpendicular to the flowing direction of the flowing port and is provided with a preset thickness, and the preset thickness is gradually reduced from the bottom to the top of the valve frame.

5. The surgically implanted prosthetic valve according to claim 4, wherein the preset thickness of the valve frame is within [0.3mm-1mm ].

6. The surgically implanted prosthetic valve of claim 1, wherein the support portions are three in number and equally spaced.

7. The surgically implanted prosthetic valve of claim 1, wherein the convergence point has a height that is lower than a height of an apex of the fixation side.

8. The surgically implanted prosthetic valve of claim 1, wherein each of the leaflets is a partially spherical structure.

9. The surgically implantable prosthetic valve of claim 8, wherein the arc radius of each leaflet is within [20mm-40mm ].

10. The surgically implantable prosthetic valve of claim 1, wherein an outer surface of the valve frame is coated with a connecting layer to which the leaflets are connected, the leaflets being connected to the valve frame by the connecting layer.

11. The surgically implantable prosthetic valve of claim 10, wherein a plurality of the leaflet fixing edges are connected to the connecting layer on one side of the inner wall of the valve frame, and the leaflet is made of the same material as the connecting layer; the valve frame is provided with a plurality of valve leaves, one side of each valve leaf close to the free edge can cover the circulation port of the valve frame.

12. The surgically implanted prosthetic valve of claim 11, wherein the melting point of the material of each leaflet is lower than the melting point of the material of the valve frame.

13. The surgically implanted prosthetic valve of one of claims 1, 10, or 11, wherein the leaflet is comprised of a TPU composite material.

14. The surgically implantable prosthetic valve of claim 1, comprising a sewing ring disposed at a lower portion of the valve frame.

15. The surgically implantable prosthetic valve of claim 14, wherein the sewing ring is an annular structure having a plurality of arcuate projections thereon.

16. The surgically implantable prosthetic valve of claim 15, wherein the arcuate projections are three in number and are evenly spaced on the sewing ring, the arcuate projections being positioned to coincide with the support portion.

17. The surgically implantable prosthetic valve of claim 14, wherein the sewing ring is covered with fabric at least at a location in contact with the valve frame; the sewing ring is provided with a hole for a sewing needle to pass through.

18. The surgically implanted prosthetic valve of claim 14, comprising a valve skirt disposed over the sewing ring and an annulus disposed outside of the valve frame.

19. The surgically implanted prosthetic valve of any of claims 14-18, comprising a valve skirt disposed over the sewing ring and an annulus disposed outside of the valve frame;

the material of the valve skirt is the same as that of the valve leaflets, and the valve skirt and the valve leaflets are integrally formed on the valve frame.

20. The surgically implantable prosthetic valve according to one of claims 10 or 11, wherein the connecting layer is integrally formed to an outer surface of the valve frame.