Artificial heart valve with clamping structure

Abstract

The invention discloses an artificial heart valve with a clamping structure. The artificial heart valve comprises a first valve seat body, a second valve seat body and an artificial valve leaflet, the second valve seat body is arranged on the outer side of the first valve seat body, and the artificial valve leaflet is arranged between the first valve seat body and the second valve seat body; the second valve seat body is provided with a parting line, the midpoint of the parting line intersects with the central axis of the second valve seat body, and the parting line divides the second valve seat body into two halves. The overall symmetry of the artificial valve is improved, meanwhile, the influence of traditional suture on the peripheral suture edge part of the artificial valve leaflet is avoided, and the service life of the artificial heart valve is prolonged. Meanwhile, the replicability and quantitative production of the whole structure of the artificial valve are guaranteed, and the production efficiency is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medicine, more particularly, to a clamping structure artificial heart valve. BACKGROUND

[0002] The artificial heart valve is an important implanted device for treating valvular heart disease, and its core function is to replace the damaged valve and reconstruct the normal blood flow function in the heart.

[0003] The currently widely used artificial heart valves in clinical practice include mechanical valves and biological valves, each of which has obvious advantages and disadvantages.

[0004] The mechanical valve is mainly made of titanium, pyrolytic carbon and other materials, which has excellent mechanical durability and can be used for more than 20 years. However, the implanters need to take anticoagulant therapy for life to reduce the risk of thrombosis, which not only increases the complexity of treatment, but also brings a continuous risk of bleeding.

[0005] The biological valve is mainly derived from porcine or bovine pericardium treated with glutaraldehyde, which has blood flow characteristics closer to the natural human valve, and usually only requires short-term anticoagulation. However, long-term implantation of biological tissue may cause problems such as calcification, wear and tear, and structural failure, and the durability is poor. Many patients, especially younger patients, may face the risk of reoperation to replace the valve.

[0006] In recent years, polymer valves have become a research hotspot due to their flexible material and good potential anticoagulant properties. However, there are still several bottlenecks in this technology: for example, manual suturing operation and uneven immersion process during preparation can damage the performance of the valve leaflet, affecting its hemodynamic performance and long-term durability; under cyclic load, wear or deformation may occur; in addition, the complex manufacturing process and low production efficiency also limit its large-scale application.

[0007] Therefore, it is urgent to develop a new type of artificial heart valve structure that can ensure long-term durability while optimizing hemodynamic performance, reducing the risk of thrombosis and calcification. At the same time, the production process can be simplified to ensure the normal function of the valve while improving production efficiency, simplifying the preparation process and improving production efficiency, making the production reproducible and quantifiable. SUMMARY

[0008] (I) Invention purpose: in order to solve the problems existing in the prior art, the purpose of the present application is to provide a clamping structure artificial heart valve.

[0009] (II) Technical solution: in order to solve the above technical problems, the present technical solution provides a clamping structure artificial heart valve, which comprises a first valve seat body, a second valve seat body and an artificial valve leaflet; the second valve seat body is arranged on the outer side of the first valve seat body, and the artificial valve leaflet is arranged between the first valve seat body and the second valve seat body; The second valve seat body is provided with a split line, the midpoint of the split line intersects with the central axis of the second valve seat body, and the split line divides the second valve seat body into two halves.

[0010] The split line intersects with the central axis of the second valve seat body at 20-40 degrees on one side of the convex column peak of the second valve seat body.

[0011] The first valve seat body is provided with a guide groove on the side facing the artificial valve leaflet, and the artificial valve leaflet root is provided with a convex rib matched with the guide groove.

[0012] The width of the inlet end of the guide groove is 1.5-2 times the width of the outlet end.

[0013] The bottom of the guide groove is provided with a wear-resistant coating, which is used to reduce the kinetic friction coefficient between the artificial valve leaflet and the first valve seat body.

[0014] The relative inner wall surface between the first valve seat body and the second valve seat body is provided with a sealing element, the inner side edge of the sealing element is matched with the outer peripheral surface of the artificial valve leaflet, and the outer side edge is fixed with the valve seat body through an annular groove.

[0015] The cross section of the sealing element is U-shaped, and the inner side edge is provided with an arc-shaped protrusion, which realizes dynamic sealing and flexible buffering between the artificial valve leaflet and the first valve seat body.

[0016] The outer peripheral surface of the second valve seat body is provided with a positioning ring, the opposite side of the positioning ring is provided with a buffer groove, and the opposite position of the second valve seat body and the positioning ring is provided with an elastic boss, which realizes radial fine adjustment when placed in the buffer groove.

[0017] The outer peripheral surface of the positioning ring is provided with an anchor, which is barb-shaped.

[0018] The artificial valve leaflet is composed of 3 equal and same valve leaflets and 1 covering film wrapped on the outer surface of the first valve seat body.

[0019] The second valve seat body and the first valve seat body are radially nested and matched, and the inner wall of the second valve seat body and the outer wall of the first valve seat body form a gap for accommodating the artificial valve leaflet.

[0020] (Three) beneficial effects: the present application provides a kind of clamping structure artificial heart valve, it can be used for embedding artificial valve leaflet by the mortise and tenon structure of first valve seat and second valve seat, realize the preparation of artificial heart valve, it is favorable to reduce the difficulty of valve leaflet attached on the valve seat, improve the effect and efficiency of valve leaflet, improve the symmetry of artificial valve whole, simultaneously avoid the influence caused by traditional sewing to artificial valve leaflet periphery sewing margin part, prolong the service life of artificial heart valve.Meanwhile, it guarantees the replicability and quantitative production of artificial valve whole structure, improves production efficiency. BRIEF DESCRIPTION OF DRAWINGS

[0021] Figure 1 It is the whole three-dimensional structure schematic diagram of a kind of clamping structure artificial heart valve embodiment one of the present application; Figure 2 It is the three-dimensional structure schematic diagram of the first valve seat body of a kind of clamping structure artificial heart valve embodiment one of the present application; Figure 3 It is the three-dimensional structure schematic diagram of the second valve seat body of a kind of clamping structure artificial heart valve embodiment one of the present application; Figure 4 It is the section structure schematic diagram of the second valve seat body of a kind of clamping structure artificial heart valve embodiment one of the present application; Figure 5 It is the three-dimensional structure schematic diagram of the first valve seat body of a kind of clamping structure artificial heart valve embodiment two of the present application; Figure 6 It is the transverse section structure schematic diagram of a kind of clamping structure artificial heart valve embodiment two of the present application; Figure 7 It is the sealing member structure schematic diagram of a kind of clamping structure artificial heart valve embodiment three of the present application; Figure 8 It is the section enlarged structure schematic diagram of a kind of clamping structure artificial heart valve embodiment three of the present application; 100-first valve seat body;200-second valve seat body;201-second split line;300-artificial valve leaflet;400-valve leaflet fixing hole;501-guide groove;502-convex rib;601-sealing member;602-arc-shaped protrusion;603-first ring groove;604-second ring groove. DETAILED DESCRIPTION

[0022] The present application will be further described below in conjunction with preferred embodiments, more details are set forth in the following description in order to fully understand the present application, however, the present application can be implemented in a variety of ways different from the description, and those skilled in the art can make similar generalization and deduction according to actual application without departing from the connotation of the present application, therefore, the protection scope of the present application should not be limited by the content of this specific embodiment.

[0023] The accompanying drawings are schematic diagrams of embodiments of the present invention. It should be noted that these drawings are for illustrative purposes only and are not drawn to scale, and should not be construed as limiting the actual scope of protection of the present invention.

[0024] Example 1

[0025] like Figures 1-4 As shown, a clamping structure artificial heart valve includes a first valve seat body 100, a second valve seat body 200, and an artificial valve leaflet 300. The first valve seat body 100 and the second valve seat body 200 have a columnar structure, with the second valve seat body 200 disposed outside the first valve seat body 100. The two are nested together using a mortise and tenon joint. The artificial valve leaflet 300 is disposed between the first valve seat body 100 and the second valve seat body 200. The second valve seat body 200 and the first valve seat body 100 are radially nested together, and a gap is formed between the inner wall of the second valve seat body 200 and the outer wall of the first valve seat body 100 to accommodate the artificial valve leaflet 300, forming a sandwich-like clamping structure.

[0026] The artificial leaflet 300 consists of three identical leaflets of equal size and a covering film that covers the outer surface of the first valve seat body 100. The covering film is adapted to conform to the outer surface of the first valve seat body 100, and the leaflets are distributed circumferentially around the first valve seat body 100. The artificial leaflet 300 has an inner diameter of 21 mm, an outer diameter of 23 mm, a height of 9.5 mm, and a thickness of 0.2 mm. The covering film covering the outer surface of the first valve seat body 100 has an inner diameter of 23 mm, an outer diameter of 23.2 mm, a height of 10.9 mm, and a thickness of 0.2 mm.

[0027] The lower portions of the first petal seat body 100 and the second petal seat body 200 are both smooth arc-shaped structures, and the upper portions are each provided with three protruding column peaks evenly distributed along the circumference, with each protruding column peak having the same shape and size.

[0028] The lower ends of the first petal seat body 100 and the second petal seat body 200 are circular, and the upper ends are composed of three raised columnar peak structures. Each raised columnar peak structure has an angle of 120° and a height of 9.5 mm, and is rounded at the corners. The geometric shape of each raised columnar peak structure is the same. The second petal seat body 200 is located 0.2 mm radially outside the first petal seat body 100. The lower part of the first petal seat is fitted inside the lower part of the second petal seat body 200. There is a gap between the first petal seat body 100 and the second petal seat body 200, which is used to fix the artificial petal leaflet 300.

[0029] When artificial valve leaflets 300 of different thicknesses are used, the inner diameter and outer diameter of the second valve seat body 200 are adjusted, and the distance between the first valve seat body 100 and the second valve seat body 200 is matched with the artificial valve leaflets 300.

[0030] The second valve seat body 200 is provided with a second split line 201, which divides the second valve seat body 200 into two halves that are axisymmetric along the diameter of the lower part of the second valve seat body 200. One end of the second split line 201 intersects with the 20-40 degrees on one side of the central axis of one of the protruding column peaks of the second valve seat body 200, and the other end intersects with the second valve seat body 200 after passing through the central axis of the second valve seat body 200.

[0031] The three protruding column peaks on the valve seat body tend to gather towards the center during the movement of the artificial valve leaflets due to the force, so these areas are not only the main stress points of the valve seat, but also the positions where the artificial stress is the largest. The split line of the second valve seat body is adjusted from the original position at the highest protruding point to the side of the protrusion, i.e., the relatively lower position, so that the joint of the valve seat body after splicing avoids the high stress area, thereby effectively reducing the risk of structural damage. The valve seat body includes a first valve seat body and a second valve seat body.

[0032] When the first valve seat body 100 and the second valve seat body 200 are combined, the protruding column peak of the second valve seat body corresponds to the protruding column peak of the first valve seat body, and the second split line 201 forms a split line.

[0033] The first valve seat body 100 and the second valve seat body 200 each include at least two structural segments of an upper part and a lower part. The shape and size of the upper part of the first valve seat body 100 and the upper part of the second valve seat body 200 are adapted, and the shape and size of the lower part of the first valve seat body 100 and the lower part of the second valve seat body 200 are adapted, and form the fitting basis of the mortise and tenon structure.

[0034] The upper part of the first valve seat body 100 is a columnar structure, and the shape and size of its cross section remain consistent along the axial direction, i.e., the inner diameter of the upper part of the first valve seat body 100 remains consistent along the axial direction. The lower part of the first valve seat body 100 is a circular ring base structure; the inner diameter of the upper part is equal to the inner diameter of the lower part, and the outer diameter of the lower part is greater than the outer diameter of the upper part. Specifically, the inner diameter of the cross section of the upper part of the first valve seat body 100 is 21 mm, the outer diameter is 23 mm, the wall thickness is 1 mm, and the height is 9.5 mm; the inner diameter of the lower part of the first valve seat body 100 is 21 mm, the outer diameter is 26 mm, and the height is 0.3 mm; the overall height of the first valve seat body is 11.2 mm.

[0035] The upper part of the second valve seat body 200 is a cylindrical structure, and the inner diameters of each cross section are different, which can change in a predetermined regular pattern along the axial direction, for example, from large to small and then to large. The lower part of the second valve seat body 200 is a hollow circular ring base structure, and the inner diameter of the upper part of the second valve seat body 200 is adapted to the inner diameter of the lower part of the first valve seat body 100. Specifically, the inner diameters of each cross section of the upper part of the second valve seat body 200 are different, the inner diameter of the smallest cross section is 21 mm, the inner diameter of the largest cross section is 26 mm, the outer diameter of the cross section is 24.2 mm, the wall thickness is 0.4 mm, and the height is 9.5 mm; the inner diameter of the lower part of the second valve seat body 200 is 21 mm, the outer diameter is 27.5 mm, and the height is 1.0 mm; the overall height of the second valve seat is 11.5 mm.

[0036] The lower part of the second valve seat body 200 is provided with a fixing groove, and the lower part of the first valve seat body 100 is fixed in the fixing groove, and the edge of the artificial valve leaflet 300 is fixed in the fixing groove and placed between the lower part of the second valve seat body 200 and the lower part of the first valve seat body 100.

[0037] The upper part and the lower part of the first valve seat body 100 and the second valve seat body 200 are respectively provided with a plurality of valve leaflet fixing holes 400 at one end, and the valve leaflet fixing holes 400 are uniformly distributed at the same horizontal position of the upper part of the first valve seat body 100 and the second valve seat body 200. The valve leaflet fixing holes 400 of the first valve seat body 100 correspond to the valve leaflet fixing holes 400 of the second valve seat body 200, that is, each valve leaflet fixing hole 400 of the first valve seat body 100 corresponds to a valve leaflet fixing hole 400 of the second valve seat body 200. The first valve seat body 100, the second valve seat body 200 and the artificial valve leaflet 300 are fixed through the valve leaflet fixing holes 400, and specifically, the first valve seat body 100, the second valve seat body 200 and the artificial valve leaflet 300 can be sewn through the valve leaflet fixing holes 400, so as to realize the re-fixing of the artificial valve leaflet 300.

[0038] The first valve seat body 100 and the second valve seat body 200 are made of biocompatible hard material, and the artificial valve leaflet 300 is made of biocompatible flexible material. Specifically, the first valve seat body 100 and the second valve seat body 200 are made of medical implant grade PEEK material, which needs to meet the standards of YY / T 0660-2008 and ASTM F2026; the artificial valve leaflet 300 is made of high molecular polymer material, which meets the requirements of biocompatibility, safety, super durability, blood compatibility and chemical stability.

[0039] Embodiment Two

[0040] A clamping structure artificial heart valve includes a first valve seat body 100, a second valve seat body 200 and an artificial valve leaflet 300. The first valve seat body 100 and the second valve seat body 200 are in a columnar structure, and the second valve seat body 200 is arranged outside the first valve seat body 100, and the two are combined with each other through a mortise and tenon structure. The artificial valve leaflet 300 is arranged between the first valve seat body 100 and the second valve seat body 200. The second valve seat body 200 is nested with the first valve seat body 100 along the radial direction, and a gap for accommodating the artificial valve leaflet 300 is formed between the inner wall of the second valve seat body 200 and the outer wall of the first valve seat body 100, forming a sandwiched clamping structure.

[0041] The second valve seat body 200 is provided with a second split line 201, which divides the second valve seat body 200 into two halves that are axisymmetric along the diameter of the lower part of the second valve seat body 200. One end of the second split line 201 intersects with the center axis of one of the convex column peaks of the second valve seat body 200 at an angle of 20-40 degrees, and the other end intersects with the second valve seat body 200 after passing through the center axis of the second valve seat body 200.

[0042] When the first valve seat body 100 and the second valve seat body 200 are combined, the convex column peaks of the second valve seat body correspond to the convex column peaks of the first valve seat body, and the second split line 201 forms a split line. The split line is used to disperse the stress at the maximum stress point of the valve seat, and when combined, the joint is just away from the high stress area, effectively reducing the risk of structural damage.

[0043] As shown in Figure 5 , Figure 6 The first valve seat body 100 is provided with a guide groove 501 on the side facing the artificial valve leaflet 300, and the artificial valve leaflet 300 is provided with a convex rib 502 that cooperates with the guide groove 501. The guide groove 501 is used to limit the sliding direction of the convex rib 502 on the artificial valve leaflet 300, ensuring the stability of the opening and closing angle of the valve leaflet. The cooperation of the convex rib 502 and the gradually widening guide groove 501 receives the centering force of the extrusion of the guide groove 501 during the sliding process, aligns the whole valve leaflet with the center axis, ensures the precise splicing of the three valve leaflets when they are closed, and avoids the sealing failure caused by the eccentricity of the valve leaflet.

[0044] The guide groove 501 is evenly distributed along the surface of the first valve seat body 100 towards the side of the artificial valve leaflet 300, 3 in total, and each guide groove 501 corresponds to a valve leaflet of the artificial valve leaflet 300, that is, the angle between every two adjacent guide grooves 501 is 120°. The guide groove 501 is a non-equal-width long strip, and the groove length of the guide groove 501 matches the movement stroke of the valve leaflet root, that is, the guide groove 501 extends from the root of the artificial valve leaflet 300 to the direction of the convex column peak along the central axis of the artificial heart valve, and the groove length is specifically 5-8 mm. The cross section of the guide groove 501 is U-shaped, and the opening is towards the artificial valve leaflet 300, with a depth of 0.6-0.8 mm, preferably 0.7 mm, which ensures that the convex ridge 502 does not fall off after embedding.

[0045] The root of the guide groove 501, that is, the end away from the convex column peak, is the entrance end of the guide groove 501, and the end close to the convex column peak is the exit end of the guide groove 501. The width of the entrance end of the guide groove 501 is 1.5-2 times the width of the exit end, specifically, the width of the entrance end is 2.5-3 mm, and the width of the exit end is 1.5-2 mm. The entrance end of the guide groove 501 linearly shrinks to the exit end.

[0046] The linearly tapered narrowing cross section of the guide groove 501 from the entrance to the exit can also be an isosceles trapezoid, and the inclination angle of the two side walls is 5°-8°, that is, the groove bottom width of the guide groove 501 is greater than the width of the end of the guide groove 501 close to the artificial valve leaflet 300. The two side walls of the guide groove 501 are circularly arc transitioned, with a round angle R=0.3 mm, which prevents scratching the surface of the convex ridge 502.

[0047] The convex ridge 502 corresponds to the guide groove 501, and the convex ridge 502 extends from the root of the artificial valve leaflet 300 to the direction of the convex column peak along the axial direction of the artificial heart valve. The convex ridge 502 is integrally formed with the artificial valve leaflet 300 and has the same material as the artificial valve leaflet 300.

[0048] The convex edges 502 are arranged in correspondence with the guide grooves 501, one convex edge 502 corresponding to one guide groove 501. The length of the convex edge 502 matches the length of the guide groove 501, which is 5-8 mm. The cross section of the convex edge 502 is semicircular or rectangular, and the difference between the width of the outlet end and the width of the convex edge 502 is 0.1-0.2 mm, ensuring smooth sliding of the convex edge 502 in the guide groove 501. The height of the convex edge 502 is 0.5-0.7 mm, preferably 0.6 mm, and in particular, the difference between the height of the guide groove 501 and the height of the convex edge 502 is 0.1 mm, to ensure smooth sliding of the convex edge 502 along the guide groove 501. The convex direction of the convex edge 502 points to the opening of the guide groove 501, ensuring natural embedding in the groove. The end of the convex edge 502 connected to the artificial valve leaflet 300 is transitioned through a circular arc with R=0.5 mm, avoiding stress concentration and fracture.

[0049] The bottom of the guide groove 501 is provided with a wear-resistant coating, which is used to reduce the motion friction coefficient between the artificial valve leaflet 300 and the first valve seat body 100. In particular, the sliding surface of the guide groove 501 in contact with the convex edge 502 is provided with the wear-resistant coating, which is continuously and uniformly arranged in the guide groove 501. The thickness of the wear-resistant coating is 5-10 μm, and the surface is an ultra-smooth surface with a roughness Ra≤0.1 μm.

[0050] The wear-resistant coating is polytetrafluoroethylene (PTFE), which has extremely low friction coefficient, wear resistance and biocompatibility, with static friction coefficient 0.04-0.05, wear rate <0.01 mm³ / (N·m), and no immune response.

[0051] The wear-resistant coating reduces the wear rate of the convex edge 502 and the guide groove 501, avoids the increase of the groove width and the thinning of the convex edge 502 due to long-term friction, prolongs the service life of the artificial valve, and makes the service life reach more than 20 years.

[0052] The gradually changing width of the guide groove 501 guides the artificial valve leaflet to automatically center during opening and closing, reducing eccentric wear; the wear-resistant coating reduces the motion friction coefficient of the valve leaflet by more than 40%, prolonging the service life of the valve.

[0053] The wear-resistant coating is attached by plasma spraying process, with bonding strength ≥5 MPa, avoiding falling off.

[0054] The surface of the wear-resistant coating can also be laser microstructured, forming micron-level pits with a diameter of 5-10 μm and a depth of 1-2 μm on the surface of the wear-resistant coating, which can store a small amount of body fluid as a lubricating medium, further reducing friction and greatly improving overall smoothness.

[0055] When the heart contracts, blood pushes the artificial valve leaflet 300 to open: the convex ridge 502 slides along the guide groove 501 from the outlet end to the inlet end, i.e. from the narrow mouth to the wide mouth. Since the inlet end is wide, even if the artificial valve leaflet 300 has a slight lateral deviation, such as 0.3 mm to the left, due to the impact of blood flow, the convex ridge 502 can still smoothly slide to the inlet end of the guide groove 501.

[0056] When the heart relaxes, the artificial valve leaflet 300 closes: the convex ridge 502 slides from the wide inlet end to the narrow outlet end. Due to the inclination of the two side walls of the guide groove 501, the convex ridge 502 will be gradually squeezed by the narrowing groove wall to the center, and finally accurately clamped into the outlet end, ensuring that the artificial valve leaflet 300 is in the center position every time it closes, avoiding eccentric wear.

[0057] Example Three

[0058] A sealing member 601 is arranged between the opposite inner walls of the first valve seat body 100 and the second valve seat body 200, the inner edge of the sealing member 601 is attached to the outer surface of the artificial valve leaflet 300, and the outer edge is fixed to the valve seat body through an annular groove.

[0059] The sealing member 601 is an annular elastic sealing member 601, as shown in Figure 7 The sealing member 601 adopts a double-layer composite material of silicone rubber and polytetrafluoroethylene. The inner layer is a medical-grade silicone rubber with a thickness of 0.3-0.5 mm and a Shore hardness A of 50-60, which provides the sealing member 601 with elastic deformation capability. The outer layer is a polytetrafluoroethylene film with a thickness of 0.05-0.1 mm. In other words, the outer layer is a film coated on the surface of the inner layer. The cross-section of the sealing member 601 is a U-shaped groove structure with an opening facing the artificial valve leaflet 300, a depth of 2-3 mm, and a width of 1.5-2 mm. The elastic parameters of the sealing member 601 are: compression modulus of 1.5-2 MPa, elongation at break ≥300%, capable of withstanding 100,000 times / day of reciprocating deformation without permanent deformation, meeting the opening and closing frequency of the heart valve.

[0060] The sealing member 601 is in the vertical position of the central axis and at the root of the artificial valve leaflet 300. Preferably, the sealing member 601 is placed above the valve leaflet fixing hole 400 in the vertical direction. When the first valve seat is provided with a guide groove 501, the sealing member 601 is placed between the valve leaflet fixing hole 400 and the guide groove 501 in the vertical direction.

[0061] As shown in Figure 8As shown, the annular groove includes a first ring groove 603 arranged on the outer sidewall of the first valve seat body 100 and a second ring groove 604 arranged on the inner sidewall of the second valve seat body 200, and the first ring groove 603 and the second ring groove 604 are coaxially aligned to form an annular clamping groove. The cross section of the annular groove is inverted trapezoidal, that is, the annular groove is wide at the opening and narrow at the bottom. The width of the opening is 1.2-1.5 mm, the width of the bottom is 0.8-1 mm, and the depth is 0.5-0.8 mm. The inner wall of the groove is provided with a 0.1 mm deep sawtooth anti-slip texture.

[0062] The outer edges of the two ends of the sealing element 601 are respectively embedded in the annular groove, that is, one end of the sealing element 601 close to the first valve seat body 100 is embedded in the first ring groove 603, and the other end close to the second valve seat body 200 is embedded in the second ring groove 604. The sealing element 601 and the annular groove are mechanically fixed by interference fit, and the interference amount is 0.1-0.2 mm. The end of the annular groove away from the sealing element 601 is the bottom of the annular groove, and the bottom of the annular groove can also be coated with a medical-grade silicone adhesive to bond the sealing element 601 and the annular groove, thereby enhancing its long-term stability.

[0063] The position of the annular groove in the vertical direction corresponds to the sealing element 601. When the artificial heart valve is combined, the two ends of the sealing element 601 are placed in the annular groove, ensuring that the sealing element 601 is axially limited and cannot slide along the valve seat body.

[0064] The inner edge of the sealing element 601 close to the first valve seat body 100 is provided with an arc-shaped protrusion 602 adapted to the motion trajectory of the artificial valve leaflet 300, as shown in Figure 8 As shown, the arc-shaped protrusion 602 realizes dynamic sealing and flexible buffering between the artificial valve leaflet 300 and the first valve seat body 100.

[0065] The arc-shaped protrusion 602 is a continuous annular protrusion located at the inner edge of the sealing element 601 close to the first valve seat body 100, and the arc-shaped protrusion 602 is integrally formed along the inner circumferential surface of the sealing element 601. The cross section of the arc-shaped protrusion 602 is semicircular, the height is 0.3-0.5 mm, the arc radius is 0.2-0.3 mm, and the width of the top of the protrusion is 0.5-0.8 mm. The surface of the arc-shaped protrusion 602 is polished to reduce frictional damage to the outer circumferential surface of the valve leaflet.

[0066] The arc-shaped protrusion 602 can be made of medical-grade silicone rubber. The end of the arc-shaped protrusion 602 connected to the sealing member 601 is connected to the sealing member 601 through a flexible connection section with a thickness of 0.1 mm. The arc-shaped protrusion 602 allows elastic deformation of ±0.2 mm in the radial direction to adapt to the change in the curvature of the outer peripheral surface when the valve leaflet is opened and closed.

[0067] The arc-shaped protrusion 602 is located in the upper 1 / 3 region of the sealing member 601 close to the inner side edge of the first valve seat body 100, i.e., the 1 / 3 region close to the free end direction of the artificial valve leaflet 300, corresponding to the dynamic fitting area of the outer peripheral surface of the artificial valve leaflet 300. When the artificial valve leaflet 300 is fully closed, the arc-shaped protrusion 602 is in contact with the outer peripheral surface close to the middle of the artificial valve leaflet 300. When the artificial valve leaflet 300 is opened to the maximum angle of about 85°, the arc-shaped protrusion 602 is in contact with the outer peripheral surface close to the root of the artificial valve leaflet 300, forming a full-stroke seal.

[0068] The specific cooperation between the sealing member 601 and the annular groove is as follows: When the artificial valve leaflet 300 is in a closed state, which is a static seal, the outer peripheral surface of the artificial valve leaflet 300 is approximately cylindrical, and the arc-shaped protrusion 602 tightly fits the outer peripheral surface of the artificial valve leaflet 300 under the action of the elastic force of the silicone rubber, forming the first sealing line. The U-shaped groove structure of the sealing member 601 is radially expanded due to the extrusion of the valve leaflet, and the outer side edge is embedded in the annular groove. The annular groove prevents the axial displacement of the sealing member 601 through the mechanical limiting of the inverted trapezoidal groove of the annular groove and the anti-slip texture. At this time, the annular groove fixes the position of the sealing member 601, and the arc-shaped protrusion 602 eliminates the microscopic gap of ≤0.05 mm between the artificial valve leaflet 300 and the sealing member 601, blocking the leakage of blood at the root of the artificial valve leaflet 300.

[0069] When the artificial valve leaflet 300 is in the opening and closing process, it is dynamic sealing. In the opening stage of the artificial valve leaflet 300: when the left ventricle contracts, the blood pushes the artificial valve leaflet 300 to open, the curvature of the outer periphery of the artificial valve leaflet 300 gradually changes from cylindrical to horn-shaped, the maximum outer diameter increases, at this time, the arc-shaped protrusion 602 is elastically compressed under the extrusion of the artificial valve leaflet 300, the flexible connection section bends, ensuring that the arc-shaped protrusion 602 always maintains surface contact with the outer periphery of the artificial valve leaflet 300, the inner side wall of the U-shaped groove of the sealing element 601 is stretched to the outside, and the elastic restoring force of the silicone rubber layer maintains the contact pressure; in the closing stage of the artificial valve leaflet 300: the left ventricle diastolic, the artificial valve leaflet 300 closes under the pressure of the blood flow, the curvature of the outer periphery of the artificial valve leaflet 300 decreases, the arc-shaped protrusion 602 rises again due to elastic recovery, and fits the outer periphery of the artificial valve leaflet 300 after contraction, at the same time, the U-shaped groove of the sealing element 601 elastically contracts, and the outer edge slightly rebounds in the annular groove, ensuring that the interference fit between the sealing element 601 and the annular groove is not loose.

[0070] Embodiment four

[0071] The outer periphery of the second valve seat body 200 is sleeved with a positioning ring, the opposite side of the positioning ring to the second valve seat body 200 is provided with a buffer groove, and the opposite position of the second valve seat body 200 to the positioning ring is provided with an elastic boss. When the elastic boss is placed in the buffer groove, radial fine adjustment and interference locking are realized.

[0072] The positioning ring is coaxially sleeved on the middle and lower outer periphery of the second valve seat body 200, covers 1 / 3 of the height of the second valve seat body 200 from the base upwards, and is located below the joint part of the artificial valve leaflet 300 and the valve seat body, thereby avoiding interfering with the opening and closing movement of the artificial valve leaflet 300.

[0073] The positioning ring is a thin-walled annular structure made of nickel-titanium memory alloy, has superelasticity and shape memory effect, the superelasticity refers to a strain of 8%, and the shape memory effect refers to the ability to restore the preset shape at body temperature. The axial length of the positioning ring is 5-8 mm, the wall thickness is 0.3-0.5 mm, the inner diameter is 0.1-0.3 mm larger than the outer diameter of the second valve seat body 200, and a radial fine adjustment gap is formed.

[0074] Three evenly distributed guide sliding grooves are formed on the inner periphery of the positioning ring along the axial direction, the width of the guide sliding groove is 0.5 mm, and the depth is 0.2 mm. Three guide ribs are arranged on the outer periphery of the second valve seat body 200, the guide ribs cooperate with the guide sliding grooves to limit the circumferential rotation of the positioning ring and only allow radial movement.

[0075] The surface of the positioning ring is electrolytically polished and treated with a titanium nitride coating, with a roughness Ra≤0.8μm, to reduce blood flow resistance and thrombosis risk.

[0076] The elastic boss is located at the axial middle position of the outer circumferential surface of the second valve seat body 200 and cooperates with the buffer groove of the inner circumferential surface of the positioning ring. When the elastic boss is radially fine-tuned, it can slide along the buffer groove, and after fine-tuning, it is embedded in the buffer groove to achieve interference locking.

[0077] The elastic boss is uniformly distributed along the circumferential surface of the outer circumferential surface of the second valve seat body 200, and the included angle between adjacent elastic bosses is 120°. The elastic boss is integrally injection molded with medical-grade silicone rubber and is connected to the positioning ring through embedded mechanical connection, that is, the elastic boss is embedded in the buffer groove of the inner wall of the positioning ring.

[0078] The elastic boss is a hemispherical protrusion, and the top of the protrusion is a circular arc surface to avoid stress concentration. A micro-nickel-titanium alloy spring wire is embedded in the elastic boss to improve the elastic recovery performance of the elastic boss. When the compression amount is 0.2mm, the recovery force is 2-3N.

[0079] Specifically, the elastic boss is located on the side surface or top surface of the guiding protrusion away from the positioning ring, and is embedded in the guiding sliding groove together with the guiding protrusion.

[0080] The elastic boss is an integrated protrusion of the guiding protrusion, which is usually arranged on the two side surfaces in the circumferential direction or the outer surface in the radial direction of the guiding protrusion. The height of the elastic boss is less than the overall height of the guiding protrusion, and the width of the elastic boss is less than the width of the guiding protrusion. The elastic boss is distributed along the entire length of the guiding protrusion in the axial direction or is distributed at key stress areas, such as the middle and both ends.

[0081] The buffer groove is correspondingly arranged on the groove wall or groove bottom of the guiding sliding groove away from the second valve seat body 200 and is precisely positioned with the elastic boss.

[0082] The elastic boss and the buffer groove are a substructure cooperating with the guiding protrusion and the guiding sliding groove, and the position of the elastic boss completely depends on the guiding protrusion and the guiding sliding groove. The elastic boss is embedded in the guiding sliding groove together with the guiding protrusion.

[0083] The buffer groove is a locally deepened or widened structure of the guiding sliding groove, and the arrangement position, shape and size of the buffer groove strictly correspond to those of the elastic boss. If the elastic boss is on the side surface of the guiding protrusion, the buffer groove is arranged on the groove wall of the guiding sliding groove. If the elastic boss is on the top surface of the guiding protrusion, the buffer groove is arranged on the groove bottom of the guiding sliding groove. The width and depth of the buffer groove are slightly larger than those of the elastic boss, so that the elastic boss can be completely embedded and retain elastic deformation space, and the axial distribution range completely coincides with that of the boss.

[0084] The outer peripheral surface of the positioning ring is provided with anchors, which are barbs. The anchors are located at the axial ends of the outer peripheral surface of the positioning ring, 1 mm away from the upper and lower edges of the positioning ring, forming upper and lower two circles of anchor arrays. The upper circle of anchors points to the direction of the valve inflow, i.e. the upstream of the blood flow, and the lower circle of barbs points to the outflow direction, ensuring bidirectional anti-displacement in the cardiac systole / diastole cycle.

[0085] The anchors are uniformly distributed along the outer peripheral surface of the positioning ring in 3 groups, each group including 2-3 anchors, spaced 30° in the circumferential direction.

[0086] The barb-shaped anchors are in the structure of isosceles triangular flake, which can specifically be 0.5 mm in base length, 0.3 mm in height, and 30° in the included angle of the tip. The surface of the anchor is passivated to avoid excessive damage when piercing into the tissue. The thickness of the root of the barb is 0.1 mm, which has a one-way elastic deformation capability, can be laid down along the implantation direction, i.e. the axial direction, with a maximum laying-down angle of 45°, and rigidly supports outward in the radial direction to prevent the displacement of the positioning ring towards the heart.

[0087] The radial fine adjustment during implantation is realized through the above structure: In the initial state, the positioning ring forms a pre-tight interference fit with the second valve seat body 200 through the elastic boss, at this time the radial gap is partially offset, and the positioning ring is in a central waiting state.

[0088] When the artificial heart valve is implanted into the patient's heart valve ring, if there is a size deviation of ±0.2 mm between the valve ring diameter and the second valve seat body 200, the positioning ring slides radially under the external extrusion force, for example, under the action of the pushing force of surgical instruments or the pressure of myocardial tissue, the elastic boss is further compressed or rebounds, and the gap of 0.1-0.3 mm is used to realize self-adaptive compensation, for example: when the valve ring diameter is too large, the positioning ring slides outward to the place where the gap is the largest; and when it is too small, it slides inward.

[0089] After adjustment, the elastic restoring force of the elastic boss and the buffer groove form a mechanical interlock, the elastic boss is embedded in the buffer groove to limit the radial displacement, and the valve is ensured to maintain a stable position in the heart movement.

[0090] After the positioning ring is fine-adjusted, the anchors on the outer peripheral surface are fixed under the action of the surgical pushing force to prevent the axial or radial displacement of the positioning ring due to the contraction / dilation of the heart.

[0091] A clamping structure artificial heart valve, through the radial nested cooperation of the first valve seat body and the second valve seat body, forms a gap for accommodating artificial valve leaflets, and adopts a mortise and tenon structure to embed the valve leaflets, which avoids the damage to the edge of the valve leaflet caused by traditional sewing, reduces the stress concentration at the sewing edge, and prolongs the service life of the valve; The split line of the first and second valve seat bodies intersects the center axis of the convex column at an angle of 30° to 60°, dispersing the load of the high stress area, and the joint after splicing avoids the key stress points, reducing the risk of structural damage. The sealing element adopts a U-shaped cross-section design, with the arc-shaped protrusion on the inner edge dynamically fitting the outer surface of the artificial valve leaflet, achieving sealing throughout the systole / diastole cycle and blocking blood leakage from the valve leaflet root. The inner layer of silicone rubber provides elastic deformation capability, and the outer layer of polytetrafluoroethylene film reduces friction damage, meeting the long-term opening and closing requirements of heart valves. The guide groove of the first valve seat body cooperates with the convex ridge at the root of the valve leaflet, automatically centering through the gradual width design when the valve leaflet is closed, ensuring precise splicing of the three valve leaflets and avoiding sealing failure and local wear caused by eccentricity. The polytetrafluoroethylene wear-resistant coating on the bottom of the guide groove reduces the coefficient of kinetic friction by more than 40%, combined with laser microstructured pit storage of body fluid lubrication, significantly extending the service life of the valve to more than 20 years. The artificial valve leaflet is composed of three equal-sized polymer valve leaflets and a covering film, with stable opening and closing angles and a maximum opening angle of about 85°, close to the hemodynamics of natural valves, reducing blood stasis and thrombosis risk. The positioning ring is made of nickel-titanium memory alloy, with a titanium nitride coating on the surface to reduce blood flow resistance; the barb-shaped anchor achieves bidirectional anti-displacement in the inflow / outflow after implantation, improving long-term stability. The embedded design of the valve seat and valve leaflet simplifies the preparation process, avoids performance damage to the valve leaflet caused by suturing, and improves production efficiency. Quantifiable control of structural parameters ensures product consistency and reproducibility, meeting large-scale production demands. The first and second valve seat bodies are made of medical-grade PEEK material, and the artificial valve leaflet is made of biocompatible high-molecular polymer, balancing the rigid support and flexible movement requirements while reducing the risk of calcification. The elastic boss and buffer groove of the positioning ring are designed with interference locking, allowing ±0.2mm radial adjustment, adapting to different patient valve ring size deviations and improving surgical implant success rate; the super-elasticity and shape memory effect of the positioning ring can adapt to the periodic movement of the heart, reducing mechanical stimulation to the surrounding tissues. By reducing the risk of thrombosis, calcification, and structural failure, the probability of secondary surgery for young patients is reduced, and compared with mechanical valves, there is no need for lifelong anticoagulant therapy, improving the quality of life for patients.

[0092] The application realizes the triple optimization of durability, hemodynamics and production efficiency through seamless chimeric design, dynamic sealing system, precise guiding mechanism and modular production process, and provides a new treatment scheme with long-term safety and clinical feasibility for patients with valvular heart disease.

[0093] The above is the description of the preferred embodiments of the present application, which can help those skilled in the art to more fully understand the technical solutions of the present application. However, these embodiments are only illustrative, and the specific implementation of the present application should not be limited to the description of these embodiments. For those skilled in the art to which the present application belongs, without departing from the concept of the present application, a number of simple deductions and transformations can be made, which should be regarded as falling within the protection scope of the present application.

Claims

1. A clamped structure prosthetic heart valve, characterized by, The artificial valve comprises a first valve seat body, a second valve seat body and an artificial valve leaflet; the second valve seat body is arranged outside the first valve seat body, and the artificial valve leaflet is arranged between the first valve seat body and the second valve seat body. The second valve seat body is provided with a split line, the midpoint of the split line intersects with the central axis of the second valve seat body, and the split line divides the second valve seat body into two halves.

2. The clamped structure prosthetic heart valve of claim 1, wherein, The split line intersects with one side of the 20-40 degree peak of the second valve seat body at the central axis of the second valve seat body.

3. The clamped structure prosthetic heart valve of claim 1, wherein, The first valve seat body is provided with a guide groove on the side facing the artificial valve leaflet, and the root of the artificial valve leaflet is provided with a convex rib matched with the guide groove.

4. The clamped structure prosthetic heart valve of claim 3, wherein, The width of the entrance end of the guide groove is 1.5-2 times the width of the exit end.

5. The clamped structure prosthetic heart valve of claim 3, wherein, The bottom of the guide groove is provided with a wear-resistant coating for reducing the kinetic friction coefficient between the artificial valve leaflet and the first valve seat body.

6. The clamped structure prosthetic heart valve of claim 1, wherein, A sealing element is arranged between the inner walls of the first valve seat body and the second valve seat body, the inner side edge of the sealing element is attached to the outer peripheral surface of the artificial valve leaflet, and the outer side edge is fixed to the valve seat body through an annular groove.

7. The clamped structure prosthetic heart valve of claim 6, wherein, The cross section of the sealing element is U-shaped, and the inner side edge is provided with an arc-shaped protrusion, which realizes dynamic sealing and flexible buffering between the artificial valve leaflet and the first valve seat body.

8. The clamped structure prosthetic heart valve of claim 1, wherein, The outer peripheral surface of the second valve seat body is sleeved with a positioning ring, the opposite side of the positioning ring is provided with a buffer groove, and the opposite position of the second valve seat body and the positioning ring is provided with an elastic boss, which realizes radial fine adjustment when placed in the buffer groove.

9. The clamped structure prosthetic heart valve of claim 8, wherein, The outer peripheral surface of the positioning ring is provided with an anchor, which is barb-shaped.

10. The clamped structure prosthetic heart valve of claim 1, wherein, The artificial valve leaflet is composed of three equal and identical valve leaflets and one covering film wrapped on the outer surface of the first valve seat body.

11. The clamped structure prosthetic heart valve of claim 1, wherein, The second valve seat body and the first valve seat body are radially nested and matched, and the inner wall of the second valve seat body and the outer wall of the first valve seat body form a gap for accommodating the artificial valve leaflet.

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