Artificial heart valve device

Abstract

The invention provides an artificial heart valve device, and relates to the technical field of heart surgeries, valve leaflets are fixedly mounted on a supporting assembly, and the inner edge of a suture ring is used for being sutured and fixed with the supporting assembly and providing support for the valve leaflets; the outer edge (second connecting surface) of the suture ring is sutured with a tissue ring, so that the valve leaflet and the supporting assembly are fixed on the tissue ring; the suture ring is a non-planar flexible ring which is continuously arranged, the inner edge (a first connecting surface) and the outer edge of the suture ring have a size difference in the radial direction and have an axial fall in the axial direction, and the surface of the suture ring is a spatial curved surface and is of a skirt-shaped size change structure, so that the outer edge of the suture ring can be subjected to radial size change; the circumferential size of the outer edge is adaptively and flexibly deformed so as to be matched with tissue rings of different sizes within a certain range, and the shape and size adaptation range of the suture ring is expanded.

Description

Technical Field

[0001] The present invention relates to the technical field of cardiac surgery, and further to an artificial heart valve device. Background Art

[0002] An artificial heart valve is a medical device implanted in the heart to treat heart valve disease. It is used to replace a damaged heart valve and restore its normal function. Depending on the material, artificial heart valves are mainly divided into two types: mechanical valves and biological valves. According to the implantation location, they can be divided into aortic valves and mitral valves.

[0003] The artificial heart valve is composed of structures such as leaflets, support components, and valve rings (suture rings). The leaflets are the main active part of the valve, responsible for opening and closing, and unidirectionally controlling the direction of blood flow. Biological leaflets can be made of pig or cow pericardium; the support component is the structure that supports the leaflets, which can be made of metal or synthetic materials; the valve ring is a ring-shaped structure, which is used to sew and fix with the corresponding human valve tissue ring, so as to position and fix the artificial heart valve as a whole and prevent leakage at the sutures.

[0004] The size of the heart valve tissue ring varies from person to person. Although existing artificial valves have different sizes, it is still common to encounter situations where the size of the human valve tissue ring is between the sizes of two adjacent artificial valves, and the shape of the valve tissue ring is irregular due to valvular disease. The two adjacent sizes cannot be accurately matched, resulting in poor adaptability of artificial heart valves. One size of artificial heart valve can only be matched within a smaller size range. The above situation is more prominent in the aortic valve position.

[0005] For those skilled in the art, how to improve the adaptability range of the size and shape of the aortic artificial heart valve is a technical problem that needs to be solved at present. Summary of the invention

[0006] The present invention provides an artificial heart valve device, which utilizes the structural design of the sewing ring to achieve flexible deformation, and can match human valve tissue rings of different sizes and shapes within a certain range, thereby improving the adaptability of the artificial valve. The specific scheme is as follows:

[0007] An artificial heart valve device comprises a valve leaflet, a support assembly, and a sewing ring, wherein the valve leaflet is fixedly mounted on the support assembly; the inner edge of the sewing ring is used for suturing and fixing with the support assembly, and the outer edge of the second connecting surface of the sewing ring is used for suturing with a human valve tissue ring;

[0008] The sewing ring is a continuously arranged non-planar flexible ring. There is a radial size difference and an axial drop between the first connecting surface and the second connecting surface of the sewing ring. The surface of the sewing ring is a spatial curved surface. The second connecting surface of the sewing ring can undergo radial size changes to match tissue rings of different shapes and sizes within a certain range.

[0009] Optionally, the support assembly includes a valve frame and a valve seat, the valve frame is used to be sutured and fixed with the valve leaflet and support the outer edge of the valve leaflet; the valve seat is used to be sutured and fixed with the sewing ring and support the first connecting surface of the sewing ring;

[0010] The valve frame and the valve seat can be sutured and fixed.

[0011] Optionally, the valve frame is provided with a plurality of valve frame suture holes extending radially therethrough, the valve seat is provided with a plurality of valve seat suture holes extending radially therethrough, and the valve leaflets are provided with a plurality of positioning suture holes along their fixed edges; the valve leaflets are sutured and fixed to the valve frame through the positioning suture holes and the corresponding valve frame suture holes, and the suture ring is sutured and fixed to the valve seat through the corresponding valve seat suture holes.

[0012] Optionally, the valve frame includes three first connecting arcs and three first expanding arcs, and the first connecting arcs and the first expanding arcs are alternately arranged end to end;

[0013] The petal seat comprises three second connecting arcs and three second expanding arcs, and the second connecting arcs and the second expanding arcs are alternately arranged end to end;

[0014] The first connecting arc and the second connecting arc contact each other to achieve connection; the axial expansion amplitude of the first expansion arc is greater than the axial expansion amplitude of the second expansion arc.

[0015] Optionally, the valve frame and the valve seat generate relative forces along the axial direction when the valve leaf moves;

[0016] The valve seat is provided with a plurality of connecting holes which penetrate axially, and the connecting holes are used for suturing and fixing with the valve frame.

[0017] Optionally, the valve seat includes a suture edge parallel to the axial direction for contacting the suture ring, and a connecting edge perpendicular to the suture edge for axially supporting the valve leaflet and the valve frame;

[0018] The radial width of the connecting edge is greater than the radial thickness of the valve frame; and the connecting hole is arranged on the connecting edge.

[0019] Optionally, the connecting edge is radially protruding from the outer surface of the sewing edge;

[0020] The inner surface of the valve seat has the same radial dimension and shape as the inner surface of the valve frame.

[0021] Optionally, the sewing ring includes a first connecting surface and a second connecting surface, wherein the first connecting surface is a cylindrical surface extending in the axial direction and is used to contact the valve seat; the second connecting surface is a skirt cone surface and is used to contact the human valve tissue ring and be sutured and fixed to the tissue ring during implantation surgery;

[0022] The width of the first connecting surface is smaller than the width of the second connecting surface.

[0023] Optionally, the sewing ring includes a middle felt cloth layer and polyester woven cloth layers arranged on both sides of the middle felt cloth layer.

[0024] The present invention provides an artificial heart valve device, wherein the valve leaflets are fixedly mounted on a support component, the inner edge of a sewing ring is used for being sutured and fixed with the support component to provide support for the valve; the outer edge of the sewing ring is used for being sutured with a human valve tissue ring to fix the valve leaflets and the support component to the tissue ring; the sewing ring is a continuously arranged non-planar flexible ring, there is a radial size difference between the inner edge and the outer edge of the sewing ring, and there is an axial drop in the axial direction, the surface of the sewing ring is a spatial curved surface, and presents a skirt-shaped size-changing structure, so that the outer edge of the sewing ring can undergo radial size changes, and the circumferential size at the outer edge can be adaptively flexibly deformed to match tissue rings of different sizes and shapes within a certain range, so that the size adaptation range of the sewing ring is expanded. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0026] Figure 1 A schematic diagram of the structure of the artificial heart valve device provided by the present invention applied to the aortic valve position;

[0027] Figure 2 A schematic diagram of the structure of an artificial heart valve device with the leaflet portion removed and applied to the aortic valve position;

[0028] Figure 3 A schematic diagram of the overall structure of the artificial heart valve device provided by the present invention;

[0029] Figure 4 A schematic diagram of the structure of the artificial heart valve device provided by the present invention without the valve leaflets;

[0030] Figure 5A cross-sectional schematic diagram of the artificial heart valve device provided by the present invention installed in a human valve tissue ring;

[0031] Figure 6 It is a schematic diagram of the structure of the leaflet in the expanded state;

[0032] Figure 7 Schematic diagram of the cross-sectional structure of the suture ring.

[0033] The figure includes:

[0034] Leaflet 1, positioning suture hole 11, valve frame 2, first connecting arc 21, first expansion arc 22, valve frame suture hole 23, valve seat 3, second connecting arc 31, second expansion arc 32, valve seat suture hole 33, connecting hole 34, suture edge 301, connecting edge 302, suture ring 4, first connecting surface 41, second connecting surface 42, felt cloth layer 401, polyester woven cloth layer 402, human valve tissue ring A, suture B, aortic valve sinus X. DETAILED DESCRIPTION

[0035] The core of the present invention is to provide an artificial heart valve device, which utilizes the structural design of the suture ring to achieve flexible deformation, match human valve tissue rings of different sizes and shapes within a certain range, and improve the adaptability of the artificial valve.

[0036] In order to enable those skilled in the art to better understand the technical solution of the present invention, the artificial heart valve device of the present invention will be described in detail below with reference to the accompanying drawings and specific implementation methods.

[0037] Combination Figure 1 , Figure 2 As shown, the present invention provides an artificial heart valve device, which can be used to replace a diseased aortic valve. Figure 1 The middle X represents the aortic sinus, which includes structures such as the valve leaflet 1, the support assembly, and the suture ring 4. The valve leaflet 1 is fixedly mounted on the support assembly. The support assembly is made of hard material and plays a supporting role. It is usually made of alloy or synthetic material. The support assembly provides support and positioning for the valve leaflet 1. The valve leaflet 1 is usually provided with three pieces, made of pig or cow pericardium; the valve leaflets 1 match each other, replacing the human heart valve, and can achieve unidirectional blood conduction.

[0038] Combination Figure 5The outer edge of the sewing ring 4 is used to sew with the human valve tissue ring A during surgical implantation of the artificial valve, thereby fixing the artificial valve to the human body. The human valve tissue ring A is formed by cutting a part of the original tissue leaflet and retaining the root; during surgical implantation, a width of the sewing ring 4 close to the outer edge is overlapped with the tissue ring A and fixed by suture. The inner edge of the sewing ring 4 is used to sew and fix with the support component, thereby fixing the support component and the human valve tissue ring A to each other. During the production process of the artificial valve, the inner edge of the sewing ring 4 is overlapped with the support component and fixed by suture.

[0039] The sewing ring 4 of the present invention is a continuously arranged non-planar flexible ring. The sewing ring 4 is a 360-degree continuous annular solid structure. The edge of the sewing ring 4 close to the center is the inner edge, and the edge away from the center is the outer edge. The sewing ring 4 is made of flexible material and can be flexibly deformed. The sewing ring 4 is a non-planar three-dimensional space structure. There is a size difference between the inner edge and the outer edge of the sewing ring 4 in the radial direction, and the diameter of the outer edge of the sewing ring 4 is greater than the diameter of the inner edge of the sewing ring 4. There is an axial drop between the inner edge and the outer edge of the sewing ring 4 in the axial direction, and the inner edge and the outer edge are not in the same plane. The sewing ring 4 has a smooth transition from the inner edge to the outer edge. The surface of the sewing ring 4 is a spatial curved surface, forming a skirt-like structure. For example, the surface of the sewing ring 4 is conical or formed by a hyperbola rotating around the axis of symmetry.

[0040] Since the sewing ring 4 can be flexibly deformed, the outer edge of the sewing ring 4 used for matching and suturing with the tissue ring can change in radial dimension, thereby allowing the circumferential dimension at the outer edge of the sewing ring 4 to change, thereby matching tissue rings of different sizes and shapes. When applied to a smaller tissue ring, the outer edge of the sewing ring 4 is retracted toward the center, and when applied to a larger tissue ring, the outer edge of the sewing ring 4 expands outwards in all directions, thereby matching tissue rings of different sizes within the range between the maximum size and the minimum size, and can match and fit with tissue rings of different shapes.

[0041] Based on this, the size adaptation range of the outer edge of the sewing ring 4 is expanded, and it can cooperate with tissue rings of more sizes and shapes, reducing the possibility that the sewing rings 4 of two adjacent specifications of artificial valves cannot well adapt to a tissue ring of a certain size. Because the sewing ring 4 can be flexibly deformed, when the outer edge of the sewing ring 4 matches the tissue ring A of a smaller size, the outer edge of the sewing ring 4 shrinks inward, and when the outer edge of the sewing ring 4 matches the tissue ring A of a larger size, the outer edge position of the sewing ring 4 expands outward.

[0042] Compared with the traditional plane-formed sewing ring structure, the present invention matches the non-planar spatial three-dimensional structure through the flexible deformation characteristics of the sewing ring 4. Figure 3 , Figure 4As shown, the sewing ring 4 is generally small at the top and large at the bottom, and the lower edge (outer edge) has a certain amount of mobility. When performing surgical suturing, the radial size of the lower edge of the sewing ring 4 can be adjusted to achieve size matching. The upper edge (inner edge) of the sewing ring 4 contacts and sutures with a hard support component, and the size of the support component is predetermined, so the size of the upper edge does not need to be adjusted. It should be noted that the sewing ring 4 of the present invention can be made of a material with a certain elastic deformation ability. When the outer edge size of the sewing ring 4 is adjusted, the circumferential size can be expanded and contracted within a certain range by stretching.

[0043] Based on the above scheme, combined with Figure 3 , Figure 4 As shown, the support assembly of the present invention includes a valve frame 2 and a valve seat 3. The valve frame 2 and the valve seat 3 are two structures independently arranged from each other, and both the valve frame 2 and the valve seat 3 are made of alloy or synthetic materials. The valve frame 2 is used to be sutured and fixed with the valve leaflets 1, and the valve frame 2 plays a supporting role for the valve leaflets 1. The valve seat 3 is used to be sutured and fixed with the sewing ring 4, and the valve seat 3 and the sewing ring 4 are sutured and fixed, and the valve frame 2 and the valve seat 3 are sutured and fixed, so as to achieve relative fixation between the valve leaflets 1, the valve frame 2, the valve seat 3, and the sewing ring 4.

[0044] Combination Figure 4 , Figure 5 As shown, the valve frame 2 is provided with a plurality of valve frame suture holes 23 penetrating in the radial direction, and the valve seat 3 is provided with a plurality of valve seat suture holes 33 penetrating in the radial direction. The direction here is explained in terms of the direction of blood flow, with the direction of blood flow being the axial direction and the direction perpendicular to the axial direction being the radial direction. Because the leaflet 1 is sutured and fixed to the valve frame 2, a plurality of positioning suture holes 11 are provided on the leaflet 1 along the fixed edge of the leaflet, and the valve frame suture holes 23 provided on the valve frame 2 are used as suture perforations. The leaflet 1 is fixedly sutured to the valve frame 2 through the positioning suture holes 11 and the corresponding valve frame suture holes 23 with sutures B. Because the suture ring 4 is sutured and fixed to the valve seat 3, the valve seat suture holes 33 provided on the valve seat 3 are used as suture perforations, and the suture ring 4 is fixedly sutured to the valve seat 3 through the valve seat suture holes 33. Suturing with sutures through corresponding holes can avoid suture position deviation. A positioning suture hole 11 is set along the fixed edge of the leaflet 1, so that the positioning suture hole 11 corresponds to the corresponding valve frame suture hole 23 of the valve frame 2, and the leaflet 1 and the valve frame 2 are sewn together with sutures B, thereby avoiding the difficulty of accurately aligning the leaflet 1 and the valve frame 2 during the suture assembly process, improving the processability, and also improving the stability and firmness of the suture between the leaflet 1 and the valve frame 2.

[0045] Through the valve frame suture holes 23 and the valve seat suture holes 34 respectively arranged on the valve frame 2 and the valve seat 3, when the valve frame 2 and the valve seat 3 are sutured to each other, the suture passes through the valve frame suture holes 23 and the corresponding valve seat suture holes 34 to relatively fix the valve frame 2 and the valve seat 3 to avoid positional displacement of the valve frame 2 and the valve seat 3.

[0046] It should be noted that the suturing between the valve leaflet 1 and the valve frame 2, the suturing between the valve seat 3 and the sewing ring 4, and the suturing between the valve frame 2 and the valve seat 3 are all pre-processed in the factory, which is the suturing assembly production process. The suturing between the sewing ring 4 and the tissue ring A is completed during the operation, which is the implantation suturing process.

[0047] Combination Figure 3 , Figure 4 As shown, the valve frame 2 of the present invention includes three first connecting arcs 21 and three first expanding arcs 22, the axial dimension of the first connecting arc 21 is smaller than the axial dimension of the three first expanding arcs 22; the first connecting arcs 21 and the first expanding arcs 22 are alternately arranged end to end, that is, the first and last ends of the first connecting arc 21 are respectively connected to the two first expanding arcs 22, and the first and last ends of the first expanding arc 22 are respectively connected to the two first connecting arcs 21, and the three first connecting arcs 21 and the three first expanding arcs 22 are alternately connected to form a structure that is continuous end to end. The valve frame 2 is an integrated annular structure made of an alloy sheet structure, which is divided into a plurality of first connecting arcs 21 and first expanding arcs 22.

[0048] The petal seat 3 includes three second connecting arcs 31 and three second expansion arcs 32. The second connecting arcs 31 and the second expansion arcs 32 are alternately connected end to end. That is, the head and tail ends of the second connecting arc 31 are respectively connected to the two second expansion arcs 32, and the head and tail ends of the second expansion arc 32 are respectively connected to the two second connecting arcs 31. The three second connecting arcs 31 and the three second expansion arcs 32 are alternately connected to form a continuous structure end to end.

[0049] The outer curvatures of the first connecting arc 21 and the second connecting arc 31 are adapted to each other, and their outer dimensions are close. The first connecting arc 21 and the second connecting arc 31 contact each other to achieve connection; the axial expansion amplitude of the first expansion arc 22 is greater than the axial expansion amplitude of the second expansion arc 32, and the first expansion arc 22 is connected and fixed to the edge of the leaflet 1 through its larger axial extension dimension.

[0050] When assembled and fixed in place, the valve frame 2 and the valve seat 3 generate relative forces along the axial direction. Figure 3 , Figure 5As shown, the edge of the leaflet 1 contacts the outer surface of the valve frame 2, and the leaflet 1 converges toward the center after folding; the upper surface of the valve frame 2 and the upper surface of the valve seat 3 clamp the leaflet 1 together, and the valve frame 2 and the valve seat 3 form a clamping valve seat 3 along the axial direction to support the valve frame 2 in the axial direction. A plurality of connecting holes 34 are arranged on the valve seat 3 along the axial direction, and the direction of the connecting holes 34 is perpendicular to the suture hole 33. The connecting holes 34 are used for suturing and fixing with the valve frame 2. When suturing the valve frame 2 and the valve seat 3, the suture is passed through the connecting holes 34, which plays a role in limiting the suture. The suture connecting the valve frame 2 and the valve seat 3 can pass through the connecting holes 34 and the valve frame suture hole 23 in sequence. Specifically, since the valve frame 2 and the valve seat 3 are only in contact at the first connecting arc 21 and the second connecting arc 31, the connecting hole 34 only needs to be arranged at the second connecting arc 31. Since the leaflet 1 and the valve frame 2 need to be sutured at all positions of the edge when they are sutured, and the valve seat 3 and the suture ring 4 need to be sutured at all positions of the edge when they are sutured, so as to ensure the sealing; and when the valve frame 2 and the valve seat 3 are connected, it is only necessary to fix the two relatively, and the number of connecting holes 34 is less than the suture holes 5, wherein the positions of the connecting holes 34 can correspond to the suture holes 23, and the sutures can be passed through the corresponding connecting holes 34 and suture holes 23 respectively when suturing.

[0051] Combination Figure 4 As shown, the valve frame 2 is a cylindrical space structure formed by a sheet material, and its surface extends in a direction roughly along the axial direction. The valve seat 3 includes a suture edge 301 parallel to the axial direction for contacting the suture ring 4, and a connecting edge 302 perpendicular to the suture edge 301 for supporting the valve frame 2 in the axial direction. The edge of the suture edge 301 is fused with the edge of the connecting edge 302 to form a folded structure with an "L" shape in cross section. The connecting edge 302 protrudes outward (away from the center) from the suture edge 301, and is combined with the suture edge 301 to form a folded structure with an "L" shape in cross section. Figure 5 The angle structure formed by the connecting edge 302 and the sewing edge 301 can be used for the sewing ring 4 to be clamped, and the outer surface of the sewing edge 301 contacts the inner surface of the sewing ring 4.

[0052] The surface of the connecting edge 302 extends in the radial direction, and the surface of the valve frame 2 extends in the axial direction. Figure 4 D in the figure represents the radial width of the connecting edge 302, and d represents the radial thickness of the valve frame 2. The radial width of the connecting edge 302 is greater than the radial thickness of the valve frame 2, and the connecting edge 302 has a larger axial support area, which can avoid misalignment between the valve frame 2 and the connecting edge 302. The connecting hole 6 is provided on the connecting edge 302, and the connecting hole 6 is perpendicular to the surface of the connecting edge 302, and can be used for sutures to pass through during suturing.

[0053] Combination Figure 5As shown, the connecting edge 302 radially protrudes and is arranged on the outer surface of the suture edge 301; the radial dimension of the inner surface of the valve seat 3 is the same as the inner surface of the valve frame 2. When the suture assembly is completed, the inner surface of the connecting edge 302 is flush with the inner surface of the valve frame 2, and the width of the connecting edge 302 is greater than the thickness of the valve frame 2. The connecting hole 6 is arranged at a position close to the outer edge of the connecting edge 302 for the suture to pass through and achieve relative fixation with the valve frame 2.

[0054] Combination Figure 1 , Figure 3 As shown, the sewing ring 4 includes a first connecting surface 41 and a second connecting surface 42, the inner edge mentioned above is located on the first connecting surface 41, and the outer edge mentioned above is located on the second connecting surface 42; the first connecting surface 41 and the second connecting surface 42 are relatively connected and fixed as a whole. The first connecting surface 41 is a cylindrical surface, which is used to contact the petal seat 3. The second connecting surface 42 is a skirt cone surface, which is small at the top and large at the bottom and gradually expands to form a spatial three-dimensional structural surface. The width of the first connecting surface 41 is smaller than the width of the second connecting surface 42. The width of the first connecting surface 41 is along the axial direction, and the width of the first connecting surface 41 is roughly equivalent to the axial width of the sewing edge 301; the second connecting surface 42 has a larger width, which can allow a wider range of size adjustment and adaptation. The second connecting surface 42 is made of a soft and tough material and has a certain axial support capacity.

[0055] Based on any of the above technical solutions and their combination, Figure 6 As shown, the sewing ring 4 provided by the present invention includes a middle felt cloth layer 401 and polyester woven cloth layers 402 arranged on both sides of the middle felt cloth layer 401, and adopts a three-layer composite structure to ensure that the sewing ring 4 has sufficient support strength and good sewing performance. Of course, the present invention does not exclude the sewing ring 4 from being made of other materials, as long as it can achieve radial swingable deformation and has sufficient axial support force to position the valve frame 2 and the valve seat 3.

[0056] In addition, the sewing ring 4 of the present invention can adopt a structural design with equal thickness at each position; it can also adopt a design with large local thickness and small local thickness, for example, the thickness of the area at the outer edge that contacts and matches the tissue ring and can be deformed is slightly smaller, while the thickness of the part used to provide support at other positions is slightly larger.

[0057] The above description of the disclosed embodiments enables one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. An artificial heart valve device, characterized in that: It comprises a valve leaflet (1), a support component, and a suture ring (4), wherein the valve leaflet (1) is fixedly mounted on the support component; the inner edge of the suture ring (4) is used for suture fixation with the support component, and the outer edge of the suture ring (4) is used for suture with the tissue ring; The suturing ring (4) is a continuously arranged non-planar flexible ring, there is a size difference between the inner edge and the outer edge of the suturing ring (4) in the radial direction, and there is an axial drop in the axial direction, the surface of the suturing ring (4) is a spatial curved surface, and the outer edge of the suturing ring (4) can undergo radial size changes to match tissue rings of different shapes and sizes within a certain range.

2. The artificial heart valve device according to claim 1, characterized in that: The support assembly comprises a valve frame (2) and a valve seat (3); the valve frame (2) is used to be sutured and fixed to the valve leaflet (1) and to support the outer edge of the valve leaflet (1); the valve seat (3) is used to be sutured and fixed to the sewing ring (4) and to support the inner edge of the sewing ring (4); The flap frame (2) and the flap seat (3) can be sutured and fixed.

3. The artificial heart valve device according to claim 2, characterized in that: The valve frame (2) is provided with a plurality of valve frame suture holes (23) extending radially therethrough, the valve seat (3) is provided with a plurality of valve seat suture holes (33) extending radially therethrough, and the valve leaf (1) is provided with a plurality of positioning suture holes (11) along its fixed edge; the valve leaf (1) is sutured and fixed to the valve frame (2) through the positioning suture holes (11) and the corresponding valve frame suture holes (23), and the suture ring (4) is sutured and fixed to the valve seat (3) through the corresponding valve seat suture holes (33).

4. The artificial heart valve device according to claim 2, characterized in that: The flap frame (2) comprises three first connecting arcs (21) and three first expanding arcs (22), wherein the first connecting arcs (21) and the first expanding arcs (22) are alternately arranged end to end in a continuous manner; The petal seat (3) comprises three second connecting arcs (31) and three second expanding arcs (32), wherein the second connecting arcs (31) and the second expanding arcs (32) are alternately arranged end to end in a continuous manner; The first connecting arc (21) and the second connecting arc (31) are aligned with each other to achieve connection; and the axial expansion amplitude of the first expanding arc (22) is greater than the axial expansion amplitude of the second expanding arc (32).

5. The artificial heart valve device according to claim 4, characterized in that: The valve frame (2) and the valve seat (3) generate relative forces along the axial direction when the valve leaf moves; The flap seat (3) is provided with a plurality of connection holes (34) which penetrate in the axial direction, and the connection holes (34) are used for suturing and fixing with the flap frame (2).

6. The artificial heart valve device according to claim 5, characterized in that: The valve seat (3) comprises a suture edge (301) parallel to the axial direction and used to contact the suture ring (4), and a connection edge (302) perpendicular to the suture edge (301) and used to support the valve leaflet (1) and the valve frame (2) along the axial direction; The radial width of the connecting edge (302) is greater than the radial thickness of the flap frame (2); and the connecting hole (34) is arranged on the connecting edge (302).

7. The artificial heart valve device according to claim 6, characterized in that: The connecting edge (302) is radially protruding and arranged on the outer surface of the sewing edge (301); The radial dimensions of the inner surface of the flap seat (3) and the inner surface of the flap frame (2) are the same.

8. The artificial heart valve device according to claim 1, characterized in that: The suture ring (4) comprises a first connecting surface (41) and a second connecting surface (42), wherein the inner edge is located on the first connecting surface (41) and the outer edge is located on the second connecting surface (42); the first connecting surface (41) is a cylindrical surface extending in the axial direction, and is used to contact and suture the valve seat (3); the second connecting surface (42) is a skirt cone surface, and is used to contact the tissue ring and be sutured and fixed through surgery; The width of the first connecting surface (41) is smaller than the width of the second connecting surface (42).

9. The artificial heart valve device according to any one of claims 1 to 8, characterized in that: The sewing ring (4) comprises a middle felt cloth layer (401) and polyester woven cloth layers (402) arranged on both sides of the middle felt cloth layer (401).

Images