Polymeric mitral heart valve

Abstract

A polymeric mitral heart valve, comprising: valve leaflets (3), a valve stent (1) and a valve ring (2), wherein the valve stent (1) is of a hollow columnar structure, the valve stent (1) comprises a first end (11) and a second end (12), the first end (11) is provided with three column peaks (13) spaced apart in the circumferential direction and column valleys (14) are correspondingly formed; the valve ring (2) is arranged at the periphery of the second end (12) of the valve stent (1), two protruding sections (21) extending towards the first end (11) in the axial direction are formed at the periphery of the valve ring (2) to be capable of corresponding to two of the column peaks (13), and a flat section (22) is formed at a position corresponding to the other column peak (13); the valve further comprises an insert (5), the insert (5) is of a hollow columnar structure matching the valve stent (1), and the insert (5) is suitable for being embedded in the valve stent (1) in the axial direction; the valve leaflets (3), the valve stent (1) and the valve ring (2) undergo one-time injection molding, and the insert (5) is embedded in the valve stent (1) during injection molding to form a whole. By optimizing the structures of the valve ring (2) and the valve stent (1), the adaptability of the valve ring (2) to a native valve ring is improved, the radial support force of the valve stent (1) is improved, and the valve performance is optimized.

Description

A polymer mitral heart valve

[0001] Cross-reference to related applications

[0002] This patent application claims priority to the Chinese patent application filed on October 25, 2023, with application number 202311394285.7 and invention name “A Polymer Mitral Heart Valve”. The full text of the above application is incorporated herein by reference. Technical Field

[0003] The present invention relates to the field of medical devices, and in particular to a polymer mitral heart valve. Background Art

[0004] Mitral regurgitation is typically caused by degenerative changes in the mitral valve structure, such as chordae tendineae elongation, chordae tendineae rupture, annular dilatation, and leaflet thickening, leading to leaflet prolapse; or by alterations in left ventricular structure and function due to ischemic or non-ischemic factors. The prevalence of mitral regurgitation increases with age. In Western countries, approximately 10% of the population over 75 years of age suffers from this condition. Patients with moderate or severe mitral stenosis or mitral regurgitation often require surgical treatment.

[0005] Currently, the most commonly used surgical mitral heart valve in clinical practice is a polymer valve, which offers excellent fatigue resistance and blood compatibility. Polymer valves are available through a variety of molding processes, including injection molding, dip coating, compression molding, electrospinning, and additive manufacturing. Injection-molded valves are characterized by high repeatability and mass production, making them suitable for industrial production.

[0006] The mitral valve usually includes a valve frame, leaflets and a valve ring. Due to the complexity of the mitral valve's anatomical structure, the structure of the existing mitral valve ring is not adapted to the native valve ring, resulting in excessive protrusion of the left ventricle and blocking the left ventricular outflow tract. In addition, since the valve frame needs to have a certain radial support force to support the leaflets, and the leaflets need to have a certain flexibility to open and close, in order to improve the radial support force of the valve frame, the leaflets and the valve frame are made of materials with different hardness, and the valve frame and the leaflets are bonded together by high-temperature injection molding and other methods. This method requires two injection moldings, which not only increases the workload of valve production but also increases the risk of poor bonding between the valve frame and the leaflets.

[0007] Therefore, it is necessary to design a polymer mitral heart valve to solve the above problems.

[0008] Summary of the Invention

[0009] An embodiment of the present invention provides a polymer mitral heart valve, which optimizes the structure of the valve ring and the valve frame, improves the adaptability of the valve ring and the native valve ring, increases the radial support force of the valve frame, and optimizes valve performance.

[0010] A polymer mitral heart valve provided by an embodiment of the present invention includes leaflets, a leaflet frame and a leaflet ring, the leaflet frame being a hollow columnar structure, the leaflet frame comprising a first end and a second end, the first end being provided with three column peaks spaced circumferentially and correspondingly formed with column valleys, the leaflets being provided at the center of the first end, the number of the leaflets being consistent with the number of the column peaks, the three leaflets being circumferentially provided and sequentially connected to two adjacent column peaks; it is characterized in that the leaflet ring is provided at the outer periphery of the second end of the leaflet frame, the leaflet ring is provided with two protrusion sections axially toward the first end at the positions corresponding to two of the column peaks in the circumferential direction, and a flat section is formed at the other column peak; the valve further includes an insert, the insert being a hollow columnar structure matching the leaflet frame, the insert being suitable for being axially embedded in the leaflet frame; the leaflets, the leaflet frame and the leaflet ring are injection molded at one time, and the insert is embedded in the leaflet frame during injection molding so as to become one with the leaflet frame.

[0011] Optionally, the protrusion segment is smoothly connected to the plane segment, the two protrusion segments are smoothly connected, and the lowest height between the two protrusion segments is the same as the height of the plane segment; the maximum height of the protrusion segment is 6mm-10mm; and the height of the plane segment is 2mm-6mm.

[0012] Optionally, a plurality of hollow holes extending axially therethrough are circumferentially spaced at the end of the valve ring, and a sealing membrane for sealing the end is provided at the end of the valve ring close to the first end, and the sealing membrane is connected to the valve frame and the valve ring by sutures.

[0013] Optionally, a suture bottom is formed at the end of the valve ring close to the second end, and the suture bottom is suitable for suturing with the native valve ring, and the axial height of the suture bottom is 0.5mm-1.5mm.

[0014] Optionally, the insert is a frame structure that matches the outer contour of the flap frame, and the insert is provided with protrusion fixing ribs and plane fixing ribs corresponding to the upper edges of the protrusion section and the plane section along the circumferential direction respectively; the protrusion fixing ribs and the plane fixing ribs are both provided with first suture holes, and the first suture holes are arranged one by one corresponding to the hollow holes along the circumferential direction.

[0015] Optionally, the insert includes a plurality of positioning peaks, a plurality of positioning teeth and a plurality of positioning protrusions, the positioning peak is arranged at the end close to the first end, and the plurality of positioning peaks are arranged circumferentially corresponding to the column peak; the positioning teeth are arranged at the end close to the second end, and the circumferential positions of the plurality of positioning teeth correspond one-to-one to the column peak and the column valley; the positioning protrusions are evenly arranged on the outer wall of the insert.

[0016] Optionally, a second suture hole is provided on the top of the positioning peak.

[0017] Optionally, the leaflet includes a free edge and a connecting edge connected to the leaflet frame. In a natural state, a gap is reserved between the free edges of adjacent leaflets, and an indented structure is formed between the midpoint of the free edge and the end point of the connecting edge, and the leaflet is semi-open.

[0018] Optionally, a line connecting the midpoint of the free edge and the midpoint of the connecting edge forms an abdominal straight line on the leaflet, and an angle between the abdominal straight line and the cross section of the leaflet frame is 30°-45°.

[0019] Optionally, the midpoint of the two endpoints of the connecting edge on the connecting arc extending circumferentially along the valve frame is M, the intersection point of the leaflets in the natural state is N, and the line connecting M and N extends obliquely from the first end to the second end. The angle between the line connecting M and N and the cross-section of the valve frame is 10°-30°.

[0020] Optionally, the free edge of a single leaflet is located in a coordinate plane, the X-axis of the coordinate system is formed by a line connecting the midpoint of the free edge and one end point of the connecting edge, the perpendicular line perpendicular to the line and passing through the midpoint of the free edge is the Y-axis, and the parametric curve Y of the free edge from the midpoint to one end point of the connecting edge is expressed by the following formula:

[0021] Among them, L1 and L2 are adjustable parameters, and respectively satisfy L3 / 10≤L1≤L3 / 5, 2L3 / 3≤L2≤3L3 / 4; L3 is the straight-line distance between the midpoint of the free edge and one end point of the connecting edge, H1, H2 and H3 are adjustable parameters, and respectively satisfy 0.05mm≤H1≤0.20mm, 0.20mm≤H2≤1.0mm, 0mm≤H3≤0.25mm.

[0022] Optionally, the thickness of the leaflet is 0.2mm-0.5mm.

[0023] Optionally, the leaflet, the valve frame and the valve ring are all made of styrene-ethylene-butylene-styrene block copolymer, polyether polyurethane, polyester polyurethane or silane-modified polyurethane.

[0024] Compared with the prior art, the technical solution of the embodiment of the present invention has beneficial effects.

[0025] For example, the valve ring of the present invention is provided with a protruding section corresponding to two column peaks and a flat section corresponding to another column peak to adapt to the native mitral valve structure. Compared with a valve ring with uniform height, the protruding section reduces the protrusion of the valve in the left ventricle after implantation, reduces the obstruction to the left ventricular outflow tract, and improves the fluid mechanics performance of the valve.

[0026] For example, inserts are set in the valve frame to provide radial support force, so that the leaflets, valve frame and valve ring can be integrally injection molded using the same polymer material, thereby optimizing valve performance, simplifying the preparation process and improving preparation efficiency.

[0027] For another example, a protruding fixing rib and a flat fixing rib are provided on the insert, and a first suture hole corresponding to the hollow hole of the valve ring is provided, so that the sealing membrane, the valve frame and the insert can be sutured together by sutures, thereby improving the connection force between the valve ring and the valve frame and enhancing the bonding force between the insert and the valve frame; a second suture hole is provided at the top of the insert positioning peak for the suture to pass through, so that the valve frame can be bent toward the central axis of the valve during the valve implantation process to facilitate its placement in the native mitral valve structure.

[0028] For example, the leaflets are designed to be semi-open in their natural state, which increases the flow rate passing through the leaflets during opening, lowers the leaflet junction point, and reduces left ventricular outflow tract obstruction; optimizes the leaflet structure, reduces valve stress, and increases valve service life. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 is a diagram of the native mitral valve structure;

[0030] FIG2 is a schematic structural diagram of a polymer mitral heart valve according to an embodiment of the present invention;

[0031] FIG3 is a front view of a polymer mitral heart valve according to an embodiment of the present invention;

[0032] FIG4 is a perspective view of a polymer mitral heart valve according to an embodiment of the present invention;

[0033] FIG5 is a top view of a polymer mitral heart valve according to an embodiment of the present invention;

[0034] FIG6 is a cross-sectional view taken along line AA of FIG4 ;

[0035] FIG7 is a schematic structural diagram of an insert in an embodiment of the present invention;

[0036] FIG8 is a schematic structural diagram of a leaflet in an embodiment of the present invention;

[0037] FIG9 is a curve of the free edge of the leaflet in the positive direction of the X-axis in an embodiment of the present invention;

[0038] FIG10 is a diagram showing the stress distribution of the leaflets of the polymer mitral heart valve when it is closed according to an embodiment of the present invention;

[0039] FIG11 is a diagram showing the stress distribution of the leaflets of a conventional mitral heart valve when the valve is closed.

[0040] Explanation of Reference Numerals: 1. Valve frame, 11. First end, 12. Second end, 13. Column peak, 14. Column valley; 2. Valve annulus, 21. Raised segment, 22. Planar segment, 23. Suture base, 24. Hollow hole; 3. Leaflet, 31. Free edge, 32. Connecting edge, 33. Abdominal straight line; 4. Sealing membrane; 5. Insert, 51. Raised fixing rib, 52. Planar fixing rib, 53. First suture hole, 54. Positioning peak, 55. Positioning protrusion, 56. Second suture hole, 57. Positioning tooth. 101. Left ventricle, 102. Left atrium, 103. Native valve annulus, 104. Junction of anterior and posterior leaflets, 105. Left ventricular outflow tract. DETAILED DESCRIPTION

[0041] In order to make the purpose, features and beneficial effects of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below with reference to the accompanying drawings. It will be understood that the specific embodiments described below are only used to explain the present invention, and are not intended to limit the present invention. In addition, the same or similar reference numerals may be used in the figures to refer to the same or similar elements in different embodiments, and the descriptions of the same or similar elements in different embodiments as well as the descriptions of the prior art elements, features, effects, etc. may be omitted. It should be noted that the central axis, axial direction, radial direction and circumferential direction described in the embodiments of the present invention respectively represent the central axis, axial direction, radial direction and circumferential direction of the valve frame 1.

[0042] 2 to 10 , an embodiment of the present invention provides a polymer mitral heart valve.

[0043] In a specific embodiment, the polymer mitral heart valve includes leaflets 3, a valve frame 1 and a valve ring 2. The valve frame 1 is a hollow cylindrical structure. The valve frame 1 includes a first end 11 and a second end 12. The first end 11 is provided with three column peaks 13 spaced circumferentially and correspondingly formed with column valleys 14. The leaflets 3 are provided at the center of the first end 11. The number of leaflets 3 is consistent with the number of column peaks 13. The three leaflets 3 are provided circumferentially and sequentially connected to two adjacent column peaks 13; the valve ring 2 is provided on the outer periphery of the second end 12 of the valve frame 1. The valve ring 2 forms two protrusion sections 21 axially toward the first end 11 at two of the column peaks 13 in the circumferential direction, and forms a plane section 22 at the other column peak 13; the valve also includes an insert 5, which is a hollow cylindrical structure matching the valve frame 1. The insert 5 is suitable for being axially embedded in the valve frame 1; the leaflets 3, the valve frame 1 and the valve ring 2 are injection molded at one time, and the insert 5 is embedded in the valve frame 1 as a whole during injection molding.

[0044] Figure 1 is a diagram of the native mitral valve structure. Referring to Figure 1, the native mitral valve is generally saddle-shaped and located between the left ventricle 101 and the left atrium 102. The native valve annulus 103 is positioned lowest at the intersection 104 of the anterior and posterior leaflets. During mitral valve replacement, positioning the protruding segment 21 of the polymer mitral valve according to the present invention at the intersection 104 of the anterior and posterior leaflets can reduce the protrusion of the valve frame 1 within the left ventricle 101, thereby reducing obstruction to the left ventricular outflow tract 105.

[0045] In practice, the protruding segments 21 and the planar segments 22 are smoothly connected, and the two protruding segments 21 are smoothly connected to each other, suitable for connection with the native annulus 103. The lowest height between the two protruding segments 21 is the same as the height of the planar segments 22. The maximum height h2 of the protruding segments 21 is 6 mm to 10 mm. The height h3 of the planar segments 22 is a fixed value within the range of 2 mm to 6 mm. This ensures that the valve annulus 2 fits the native annulus 103 as closely as possible, while minimizing the protruding height h4 within the left ventricle 101 to reduce outflow tract obstruction.

[0046] In some embodiments, a plurality of axially extending hollow holes 24 are circumferentially spaced at the end of the valve ring 2. The presence of the hollow holes 24 can improve the flexibility of the valve ring 2, so that the valve can be closer to the native mitral valve structure after implantation in the human body; due to the presence of the hollow holes 24, a sealing membrane 4 is required to be provided at the end of the valve ring 2 close to the first end 11 to close the end, and the sealing membrane 4 is connected to the valve frame 1 and the valve ring 2 by sutures.

[0047] In some embodiments, a suture bottom 23 is formed at the end of the valve ring 2 near the second end 12. The suture bottom 23 is suitable for suturing with the native valve ring 103 through sutures. The axial height h1 of the suture bottom 23 is 0.5mm-1.5mm. If the axial height h1 is too large, it will be difficult for the suture needle to pass through. If it is too small, the suture needle will easily pull the valve ring 2 when passing through, resulting in a larger gap at the bottom.

[0048] In some embodiments, the insert 5 is a frame structure that matches the outer contour of the valve frame 1, and the insert 5 is circumferentially provided with a protrusion fixing rib 51 and a plane fixing rib 52 corresponding to the upper edges of the protrusion section 21 and the plane section 22 respectively; the protrusion fixing rib 51 and the plane fixing rib 52 are both provided with a first suture hole 53, and the first suture hole 53 is arranged one by one corresponding to the hollow hole 24 along the circumferential direction.

[0049] During specific implementation, the sealing membrane 4 is connected to the valve frame 1 by sutures passing through the hollow hole 24 and the first suture hole 53, and the sealing membrane 4, the valve frame 1 and the insert 5 are sutured together by sutures to improve the connection force between the valve ring 2 and the valve frame 1 and enhance the bonding force between the insert 5 and the valve frame 1.

[0050] Referring to Figure 7, in some embodiments, the insert 5 includes multiple positioning peaks 54, multiple positioning teeth 57 and multiple positioning protrusions 55. The positioning peak 54 is arranged at the end close to the first end 11, and the multiple positioning peaks 54 are arranged circumferentially corresponding to the column peaks 13; the positioning teeth 57 are arranged at the end close to the second end 12, and the circumferential positions of the multiple positioning teeth 57 correspond one-to-one to the column peaks 13 and the column valleys 14, and each positioning tooth 57 includes two teeth; the positioning protrusions 55 are evenly arranged on the outer wall of the insert 5.

[0051] In some embodiments, a second suture hole 56 is provided at the top of the positioning peak 54. The second suture hole 56 can be used for suture to pass through, so that the valve frame 1 can be bent toward the central axis of the valve during valve implantation to facilitate placement into the native mitral valve structure.

[0052] In some embodiments, the leaflets 3 include free edges 31 and connecting edges 32 for connecting to the valve frame 1. In a natural state, a gap is reserved between the free edges 31 of adjacent leaflets 3, and a concave structure is formed between the midpoint of the free edge 31 and the endpoint of the connecting edge 32, resulting in a semi-open shape. The semi-open leaflets 3 allow flow to pass even when no load is applied, whereas the fully closed leaflets 3 in the natural state must be subjected to a load that causes them to deform and open in order to achieve the same flow rate. When a greater load is applied, the semi-open leaflets 3 continue to deform and open while remaining semi-open. Therefore, when the same load is applied, the flow rate is greater than that of the fully closed leaflets in the natural state, i.e., the amount of blood passing through the valve when open is increased. It should be noted that the semi-open leaflets 3 have an intersection N, which is located on the central axis 38 and between the midpoint of the free edge 31 and the second end 12.

[0053] 8 , in some embodiments, a line connecting the midpoint of the free edge 31 and the midpoint of the connecting edge 32 forms an abdominal straight line 33 on the leaflet 3 , and an angle β between the abdominal straight line 33 and the cross section 39 of the valve frame 1 is 30°-45°.

[0054] In some embodiments, the midpoint of the two endpoints of the connecting edge 32 on the connecting arc extending circumferentially along the valve frame 1 is M. The intersection point of the leaflets in the natural state is N. The line connecting the two points extends obliquely from the first end 11 to the second end 12. The angle α between the line connecting M and N and the cross-section 39 of the valve frame 1 is 10°-30°, preferably 20°. When the leaflets 3 are closed, the intersection point N on the leaflets 3 moves toward the second end 12 compared to when they are open. That is, in FIG1 , space is left to the right of the left ventricular outflow tract 105 to reduce obstruction of the left ventricular outflow tract 105 when the leaflets 3 are closed. The cross-section 39 is an arbitrary section perpendicular to the central axis 38.

[0055] 8 and 9 , in some embodiments, the free edge 31 of a single leaflet 3 is located in a coordinate plane, where the X-axis of the coordinate system is formed by a line connecting the midpoint of the free edge 31 and one end point of the connecting edge 32, and the perpendicular line perpendicular to the line and passing through the midpoint of the free edge 31 is the Y-axis. The curve Y of the free edge 31 in the positive direction of the X-axis, i.e., the parametric curve Y between the midpoint of the free edge 31 (i.e., the point where x=0, y=0 in the coordinate system) and one end point of the connecting edge 32 (i.e., the point where x=L3, y=0 in the coordinate system), is expressed by the following formula:

[0056] Wherein, L1 and L2 are adjustable parameters, satisfying L3 / 10 ≤ L1 ≤ L3 / 5 and 2L3 / 3 ≤ L2 ≤ 3L3 / 4, respectively. L3 is the straight-line distance between the midpoint of free edge 31 and one endpoint of connecting edge 32. H1, H2, and H3 are adjustable parameters, satisfying 0.05 mm ≤ H1 ≤ 0.20 mm, 0.20 mm ≤ H2 ≤ 1.0 mm, and 0 mm ≤ H3 ≤ 0.25 mm. Parameter curve Y, extending from the midpoint of free edge 31 (x = 0, y = 0) to one endpoint of connecting edge 32 (x = L3, y = 0), has a first peak, a first trough, and a second peak, respectively. H1, H2, and H3 are the y values ​​at the first peak, first trough, and second peak, respectively.

[0057] After determining the curve of the free edge 31, the abdominal straight line 33 is obtained according to the angle between the abdominal straight line 33 and the cross section of the valve frame 1. The intersection of the curved surface formed by the free edge 31 extending along the abdominal straight line 33 and the cylinder formed by the inner diameter of the valve frame 1 is the connecting edge 32. The curved surface surrounded by these three lines is the shape of the leaflet 3.

[0058] Referring to Figures 10 and 11, the stress distribution of the leaflets is compared under a pressure of 120 mmHg. It can be seen from the figures that the maximum stress of the valve leaflets provided by the example of the present invention is 1.351 MPa, and the maximum stress of the existing mitral valve leaflets is 2.618 MPa. The maximum stress is reduced by 93.8%. The reduction in maximum stress will greatly improve the life of the valve.

[0059] In some embodiments, the thickness of the leaflet 3 is 0.2 mm to 0.5 mm to ensure flexibility and fatigue resistance.

[0060] In some embodiments, the materials of the leaflets 3, the valve frame 1 and the valve ring 2 are all polymer materials, and the polymer materials are selected from one or a combination of polyether polyurethane, polyester polyurethane or silane-modified polyurethane, and triblock copolymer.

[0061] To sum up, the valve ring 2 of the embodiment of the present invention is provided with a protruding section 21 corresponding to two column peaks 13, and a flat section 22 corresponding to another column peak 13 to adapt to the native mitral valve structure. Compared with a valve ring with uniform height, the protruding setting reduces the protrusion of the valve in the left ventricle 101 after implantation, reduces the obstruction to the left ventricular outflow tract 105, and improves the fluid mechanics performance of the valve.

[0062] Furthermore, the embodiment of the present invention provides an insert 5 in the valve frame 1 to provide radial support force, so that the leaflets 3, valve frame 1 and valve ring 2 can be integrally injection molded using the same polymer material, thereby optimizing valve performance, simplifying the preparation process, and improving preparation efficiency.

[0063] Furthermore, the embodiment of the present invention provides a protruding fixing rib 51 and a flat fixing rib 52 on the insert 5, and provides a first suture hole 53 corresponding to the hollow hole 24 of the valve ring 2, so that the sealing membrane 4, the valve frame 1 and the insert 5 can be sutured together by sutures, thereby improving the connection force between the valve ring 2 and the valve frame 1 and enhancing the bonding force between the insert 5 and the valve frame 1; a second suture hole 56 is provided at the top of the positioning peak 54 of the insert 5 for the suture to pass through, so that the valve frame 1 can be bent toward the central axis of the valve during the valve implantation process to facilitate its placement in the native mitral valve structure.

[0064] Furthermore, the leaflet 3 of the embodiment of the present invention is designed to be in a semi-open state in a natural state, thereby reducing obstruction of the left ventricular outflow tract 105; optimizing the structure of the leaflet 3, reducing valve stress, and increasing the service life of the valve.

[0065] Although specific embodiments have been described above, these embodiments are not intended to limit the scope of the present disclosure, even when only a single embodiment is described with respect to specific features. The feature examples provided in the present disclosure are intended to be illustrative, not limiting, unless otherwise stated. In specific implementations, the technical features of one or more dependent claims may be combined with the technical features of the independent claims, depending on actual needs and where technically feasible, and the technical features from the corresponding independent claims may be combined in any appropriate manner rather than solely through the specific combinations listed in the claims.

[0066] Although the present invention is disclosed as above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention should be based on the scope defined by the claims.

Claims

1. A polymer mitral heart valve, comprising leaflets, a valve frame and a valve ring, wherein the valve frame is a hollow columnar structure, the valve frame comprises a first end and a second end, the first end is provided with three column peaks spaced apart along the circumferential direction and correspondingly formed with column valleys, the leaflets are provided at the center of the first end, the number of the leaflets is consistent with the number of the column peaks, and the three leaflets are provided along the circumferential direction and sequentially connect two adjacent column peaks; characterized in that The valve ring is arranged on the outer periphery of the second end of the valve frame, and the valve ring forms two protrusion sections axially toward the first end at two of the column peaks in the circumferential direction, and forms a flat section at the other column peak; the valve also includes an insert, which is a hollow columnar structure matching the valve frame, and the insert is suitable for being axially embedded in the valve frame; the leaflet, the valve frame and the valve ring are injection molded at one time, and the insert is embedded in the valve frame during injection molding to become one with the valve frame.

2. The polymer mitral heart valve according to claim 1, characterized in that: The protrusion segment is smoothly connected to the plane segment, the two protrusion segments are smoothly connected, the lowest height between the two protrusion segments is the same as the height of the plane segment; the maximum height of the protrusion segment is 6mm-10mm; the height of the plane segment is 2mm-6mm.

3. The polymer mitral heart valve according to claim 1, characterized in that: The end of the valve ring is circumferentially spaced with a plurality of hollow holes extending axially therethrough. The end of the valve ring close to the first end is provided with a sealing membrane for sealing the end. The sealing membrane is connected to the valve frame and the valve ring by sutures.

4. The polymer mitral heart valve according to claim 3, characterized in that: The valve ring is formed with a suture bottom at the end portion close to the second end, the suture bottom is suitable for suturing with the native valve ring, and the axial height of the suture bottom is 0.5mm-1.5mm.

5. The polymer mitral heart valve according to claim 3, characterized in that: The insert is a frame structure that matches the outer contour of the valve frame, and the insert is provided with protrusion fixing ribs and plane fixing ribs along the circumferential direction corresponding to the upper edges of the protrusion section and the plane section respectively; the protrusion fixing ribs and the plane fixing ribs are both provided with first suture holes, and the first suture holes are arranged one by one with the hollow holes along the circumferential direction.

6. The polymer mitral heart valve according to claim 1, characterized in that: The insert includes a plurality of positioning peaks, a plurality of positioning teeth and a plurality of positioning protrusions. The positioning peak is arranged at the end portion close to the first end, and the plurality of positioning peaks are arranged circumferentially corresponding to the column peaks; the positioning teeth are arranged at the end portion close to the second end, and the circumferential positions of the plurality of positioning teeth correspond one-to-one to the column peaks and the column valleys; the positioning protrusions are evenly arranged on the outer wall of the insert.

7. The polymer mitral heart valve according to claim 6, characterized in that: A second suture hole is arranged on the top of the positioning peak.

8. The polymer mitral heart valve according to claim 1, characterized in that: The leaflet includes a free edge and a connecting edge connected to the leaflet frame. In a natural state, a gap is reserved between the free edges of adjacent leaflets, and a concave structure is formed between the midpoint of the free edge and the end point of the connecting edge, and the leaflet is in a semi-open shape.

9. The polymer mitral heart valve according to claim 8, characterized in that: A line connecting the midpoint of the free edge and the midpoint of the connecting edge forms an abdominal straight line on the leaflet, and an angle between the abdominal straight line and the cross section of the leaflet frame is 30°-45°.

10. The polymer mitral heart valve according to claim 8, characterized in that: The midpoint of the two endpoints of the connecting edge on the connecting arc extending circumferentially along the valve frame is M, the intersection point of the leaflets in the natural state is N, and the line connecting M and N extends obliquely from the first end to the second end. The angle between the line connecting M and N and the cross-section of the valve frame is 10°-30°.

11. The polymer mitral heart valve according to claim 8, characterized in that: The free edge of a single leaflet is located in a coordinate plane, the X axis of the coordinate system is formed by a line connecting the midpoint of the free edge and one end point of the connecting edge, the vertical line perpendicular to the connecting line and passing through the midpoint of the free edge is the Y axis, and the parameter curve Y between the free edge from the midpoint to one end point of the connecting edge is expressed by the following formula: Among them, L1 and L2 are adjustable parameters, and respectively satisfy L3 / 10≤L1≤L3 / 5, 2L3 / 3≤L2≤3L3 / 4; L3 is the straight-line distance between the midpoint of the free edge and an end point of the connecting edge, H1, H2 and H3 are adjustable parameters, and respectively satisfy 0.05mm≤H1≤0.20mm, 0.20mm≤H2≤1.0mm, 0mm≤H3≤0.25mm.

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