An artificial heart valve device

Abstract

The present invention provides an artificial heart valve device, which relates to the technical field of cardiac surgery. The leaflets are fixedly installed on a support assembly, and the inner edge of the sewing ring is used to be sutured and fixed to the support assembly to provide support for the leaflets; the outer edge (second connecting surface) of the sewing ring is used to be sutured and fixed to the tissue ring to fix the leaflets and the support assembly to the tissue ring; the sewing ring is a continuously arranged non-planar flexible ring, and there is a size difference in the radial direction and an axial drop in the axial direction between the inner edge (first connecting surface) and the outer edge of the sewing ring. The surface of the sewing ring is a spatial curved surface with 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 within a certain range, thereby expanding the shape and size adaptation range of the sewing ring.

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] A prosthetic heart valve is a medical device implanted in the heart to treat heart valve disease. It replaces a damaged heart valve and restores its normal function. Depending on the material used, prosthetic heart valves are primarily categorized as mechanical and bioprosthetic. Depending on the implant location, they are divided into the aortic valve and the mitral valve.

[0003] An artificial heart valve consists 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, thereby positioning and fixing the artificial heart valve as a whole and preventing leakage at the sutures.

[0004] The size of the heart valve annulus varies from person to person. Although existing artificial valves come in a variety of sizes, it's common to find that the size of the valve annulus falls between two adjacent artificial valve sizes. Valvular disease can also lead to irregular annular morphology, making it difficult to precisely match two adjacent sizes. This results in poor adaptability of the artificial heart valve, forcing a single artificial heart valve to fit only within a narrow size range. This situation is particularly pronounced in the aortic valve.

[0005] For those skilled in the art, how to improve the adaptability range of the size and shape of artificial aortic heart valves 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 that utilizes the structural design of the sewing ring to achieve flexible deformation. This device 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 the 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 change radially 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, wherein 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 flap frame and the flap seat can be sutured and fixed.

[0011] Optionally, the valve frame is provided with a plurality of valve frame suture holes that pass through in the radial direction, the valve seat is provided with a plurality of valve seat suture holes that pass through in the radial direction, and the leaflet is provided with a plurality of positioning suture holes along its fixed edge; the leaflet is 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 expansion arcs, and the first connecting arcs and the first expansion arcs are alternately arranged end to end;

[0013] The petal seat includes 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 leaflet moves;

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

[0018] The radial width of the connecting edge is greater than the radial thickness of the flap 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 petal seat has the same radial size and shape as the inner surface of the petal 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 conical 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, in which the leaflets are fixedly mounted on a support assembly, and the inner edge of the sewing ring is used for suturing and fixing with the support assembly to provide support for the valve; the outer edge of the sewing ring is used for suturing with the human valve tissue ring to fix the leaflets and the support assembly to the tissue ring; the sewing ring is a continuously arranged non-planar flexible ring, and there is a radial size difference between the inner edge and the outer edge of the sewing ring, and an axial drop in the axial direction; the surface of the sewing ring is a spatial curved surface, and has 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 adaptively undergo flexible deformation to match tissue rings of different sizes and shapes within a certain range, thereby expanding the size adaptation range of the sewing ring. 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 following briefly introduces the drawings required for use in the embodiments or the description of the prior art. 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 any creative work.

[0026] Figure 1 A schematic structural diagram 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 leaflets 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 structural diagram of the artificial heart valve device provided by the present invention with the leaflets removed;

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

[0031] Figure 6 This 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 diagram 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 layer 401, polyester fabric 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 uses the structural design of the sewing 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] Combine Figure 1 、 Figure 2 As shown, the present invention provides an artificial heart valve device that can be used to replace a diseased aortic valve. Figure 1 The middle X represents the aortic sinus, which includes the valve leaflets 1, support assembly, and sewing ring 4. The valve leaflets 1 are fixedly mounted to the support assembly. The support assembly is made of a hard material and provides support, usually alloy or synthetic materials. The support assembly provides support and positioning for the valve leaflets 1. The valve leaflets 1 are usually provided in three pieces, made from porcine or bovine pericardium. The leaflets 1 match each other, replacing the human heart valve, and can achieve unidirectional blood flow.

[0038] Combine 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 portion of the original tissue leaflet and retaining the root. During surgical implantation, a width of the sewing ring 4 near the outer edge is overlapped with the tissue ring A and fixed with sutures. The inner edge of the sewing ring 4 is used to sew and fix with the support assembly, thereby fixing the support assembly 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 assembly and fixed with sutures.

[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 a flexible material and can undergo flexible deformation. The sewing ring 4 is a non-planar three-dimensional spatial structure. There is a radial size difference between the inner and outer edges of the sewing ring 4. The diameter of the outer edge of the sewing ring 4 is larger than the diameter of the inner edge of the sewing ring 4. There is an axial drop between the inner and outer edges of the sewing ring 4. The inner and outer edges are not in the same plane. The sewing ring 4 smoothly transitions 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 an axis of symmetry.

[0040] Since the sewing ring 4 can be flexibly deformed, the outer edge of the sewing ring 4 used for matching the tissue ring for suturing can change in radial size, thereby allowing the circumferential size 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 to all sides, 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 outer edge of the sewing ring 4 has a wider range of size adaptations, enabling it to cooperate with tissue rings of more sizes and shapes, reducing the possibility of the sewing rings 4 of two adjacent artificial valve sizes not being able to properly 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 smaller tissue ring A, the outer edge of the sewing ring 4 contracts inward, and when the outer edge of the sewing ring 4 matches the larger tissue ring A, the outer edge of the sewing ring 4 expands outward.

[0042] Compared with the traditional plane-formed sewing ring structure, the present invention matches the flexible deformation characteristics of the sewing ring 4 with the non-planar spatial three-dimensional structure. Figure 3 、 Figure 4As shown, the sewing ring 4 is generally smaller at the top and larger at the bottom, with a certain amount of movement at the lower edge (outer edge). During surgical suturing, the radial dimension 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 sews against a rigid support assembly. The dimensions of the support assembly are predetermined, so the dimensions of the upper edge do 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 degree of elastic deformation. When the outer edge of the sewing ring 4 is adjusted, the circumferential dimension can be expanded and contracted within a certain range by stretching.

[0043] On the basis of 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 independently arranged structures, 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 to the valve leaflets 1, and the valve frame 2 provides support for the valve leaflets 1. The valve seat 3 is used to be sutured and fixed to the sewing ring 4. The valve seat 3 and the sewing ring 4 are sutured and fixed to each other, and the valve frame 2 and the valve seat 3 are sutured and fixed to each other, thereby achieving relative fixation between the valve leaflets 1, the valve frame 2, the valve seat 3, and the sewing ring 4.

[0044] Combine Figure 4 、 Figure 5 As shown, the valve frame 2 is provided with a plurality of valve frame suture holes 23 extending radially therethrough, and the valve seat 3 is provided with a plurality of valve seat suture holes 33 extending radially therethrough. The direction here is described 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. The valve frame suture holes 23 provided on the valve frame 2 serve as perforations for sutures B. 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 sewing ring 4 is sutured and fixed to the valve seat 3, the valve seat suture holes 33 provided on the valve seat 3 serve as suture perforations. The sewing ring 4 is fixedly sutured to the valve seat 3 through the valve seat suture holes 33. Suturing with sutures through corresponding holes can prevent the suture position from shifting. 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 flap frame suture holes 23 and flap seat suture holes 34 respectively set on the flap frame 2 and flap seat 3, when the flap frame 2 and flap seat 3 are sutured to each other, the suture passes through the flap frame suture holes 23 and the corresponding flap seat suture holes 34 to relatively fix the flap frame 2 and flap seat 3 to avoid position displacement of the flap frame 2 and flap seat 3.

[0046] It should be noted that the suturing between the leaflets 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 at the factory and constitute the suturing assembly production process. The suturing between the sewing ring 4 and the tissue ring A is completed during surgery and constitutes the implantation suturing process.

[0047] Combine Figure 3 、 Figure 4 As shown, the valve frame 2 of the present invention includes three first connecting arcs 21 and three first expansion arcs 22. The axial dimension of the first connecting arc 21 is smaller than the axial dimension of the three first expansion arcs 22. The first connecting arcs 21 and the first expansion arcs 22 are alternately arranged end to end. That is, the end ends of the first connecting arc 21 are respectively connected to the two first expansion arcs 22, and the end ends of the first expansion arc 22 are respectively connected to the two first connecting arcs 21. The three first connecting arcs 21 and the three first expansion arcs 22 are alternately connected to form an end-to-end continuous structure. The valve frame 2 is an integrated annular structure made of an alloy sheet structure, divided into a plurality of first connecting arcs 21 and first expansion 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 the 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 petal frame 2 and the petal 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 flap frame 2, and the leaflet 1 converges toward the center after folding; the upper surface of the flap frame 2 and the upper surface of the flap seat 3 jointly clamp the leaflet 1, and the flap frame 2 and the flap seat 3 form a clamping flap seat 3 along the axial direction to support the flap frame 2 in the axial direction. A plurality of connecting holes 34 are provided on the flap seat 3, and the direction of the connecting holes 34 is perpendicular to the suture holes 33. The connecting holes 34 are used for suturing and fixing with the flap frame 2. When suturing the flap frame 2 and the flap seat 3, the suture is passed through the connecting holes 34, which acts as a limit for the suture. The suture connecting the flap frame 2 and the flap seat 3 can pass through the connecting holes 34 and the flap frame suture holes 23 in sequence. Specifically, since the flap frame 2 and the flap seat 3 only contact at the first connecting arc 21 and the second connecting arc 31, the connecting holes 34 only need to be provided at the second connecting arc 31. Since the leaflet 1 and the flap frame 2 need to be sutured at all positions of the edge when suturing, the flap seat 3 and the suture ring 4 need to be sutured at all positions of the edge when suturing, so as to ensure the sealing; and when the flap frame 2 and the flap 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, among which 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] Combine Figure 4 As shown, the flap frame 2 is a cylindrical space structure formed by sheet material, and its surface extends in the direction of the axis. The flap seat 3 includes a suture edge 301 parallel to the axis for contacting the suture ring 4, and a connecting edge 302 perpendicular to the suture edge 301 for supporting the flap frame 2 in the axial direction. The edge of the suture edge 301 and the edge of the connecting edge 302 are fused together 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 angled 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 petal frame 2 extends in the axial direction. Figure 4 D 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, providing a larger axial support area for the connecting edge 302 and preventing misalignment between the valve frame 2 and the connecting edge 302. Connecting holes 6 are provided on the connecting edge 302, perpendicular to the surface of the connecting edge 302, and allow sutures to pass through during suturing.

[0053] Combine Figure 5As shown, the connecting edge 302 protrudes radially from the outer surface of the suture edge 301; the radial dimensions of the inner surface of the flap seat 3 are the same as the inner surface of the flap frame 2. When the suture assembly is completed, the inner surface of the connecting edge 302 is flush with the inner surface of the flap frame 2, and the width of the connecting edge 302 is greater than the thickness of the flap frame 2. The connecting hole 6 is set 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 flap frame 2.

[0054] Combine Figure 1 、 Figure 3 As shown, the sewing ring 4 includes a first connecting surface 41 and a second connecting surface 42, wherein the aforementioned inner edge is located on the first connecting surface 41, and the aforementioned outer edge 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 central felt layer 401 and polyester woven fabric layers 402 disposed on both sides of the central felt layer 401. This three-layer composite structure ensures that the sewing ring 4 has sufficient support strength and good suturing performance. Of course, the present invention does not exclude the possibility of the sewing ring 4 being made of other materials, as long as it can achieve radial swingable deformation and provide sufficient axial support to position the valve frame 2 and 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 thickness in some parts and small thickness in some parts, 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 is intended to enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to those 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 is not limited to the embodiments shown herein but is intended to conform 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 leaflet (1), a support assembly, and a suturing ring (4), wherein the leaflet (1) is fixedly mounted on the support assembly; the inner edge of the suturing ring (4) is used for suturing and fixing with the support assembly, and the outer edge of the suturing ring (4) is used for suturing with the tissue ring; The suture ring (4) is a continuously arranged non-planar flexible ring, and there is a size difference between the inner edge and the outer edge of the suture ring (4) in the radial direction and an axial drop in the axial direction. The surface of the suture ring (4) is a spatial curved surface, and the outer edge of the suture ring (4) can undergo radial size changes to match tissue rings of different shapes and sizes within a certain range. The support assembly comprises a flap frame (2) and a flap seat (3), wherein the flap frame (2) is used for being sutured and fixed to the flap (1) and supporting the outer edge of the flap (1); the flap seat (3) is used for being sutured and fixed to the sewing ring (4) and supporting the inner edge of the sewing ring (4); The flap frame (2) and the flap seat (3) can be sutured and fixed; The valve frame (2) and the valve seat (3) generate relative forces along the axial direction when the valve leaflets move; The petal seat (3) is provided with a plurality of connecting holes (34) extending axially therethrough, and the connecting holes (34) are used for suturing and fixing with the petal frame (2); The valve seat (3) comprises a suture edge (301) parallel to the axial direction and used for contacting the suture ring (4), and a connecting edge (302) perpendicular to the suture edge (301) and used for supporting the valve leaflet (1) and the valve frame (2) in the axial direction; The radial width of the connecting edge (302) is greater than the radial thickness of the flap frame (2); the connecting hole (34) is provided on the connecting edge (302); 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.

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

3. The artificial heart valve device according to claim 1, wherein: 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; 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; The first connecting arc (21) and the second connecting arc (31) are aligned with 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).

4. The artificial heart valve device according to claim 1, wherein: 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 for contacting and suturing the valve seat (3); the second connecting surface (42) is a skirt conical surface, and is used for contacting the tissue ring and being fixed by surgical suturing; The width of the first connecting surface (41) is smaller than the width of the second connecting surface (42).

5. The artificial heart valve device according to any one of claims 1 to 4, 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).

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