A clamped structure prosthetic heart valve

Abstract

A clamping structure artificial heart valve comprises a first valve seat body, a second valve seat body and artificial valve leaflets; the second valve seat body is arranged outside the first valve seat body, and the artificial valve leaflets are 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. The present application improves the symmetry of the whole artificial valve, avoids the influence of traditional sewing on the peripheral sewing edge part of the artificial valve leaflets, prolongs the service life of the artificial heart valve, ensures the replicability and quantitative production of the whole structure of the artificial valve, and improves the production efficiency.

Description

Technical Field

[0001] This invention relates to the field of medical technology, and more specifically, to a clamping structure artificial heart valve. Background Technology

[0002] Artificial heart valves are important implantable devices for treating valvular heart disease. Their core function is to replace damaged valves and restore normal blood flow within the heart.

[0003] Currently, the two most widely used types in clinical practice are mechanical valves and bioprosthetic valves, each with its own distinct advantages and disadvantages.

[0004] Mechanical valves are mostly made of materials such as titanium and pyrolytic carbon, and have excellent mechanical durability, lasting for more than 20 years. However, implanted patients need to receive anticoagulation therapy for life to reduce the risk of thrombosis. This not only increases the complexity of treatment but also brings the risk of continuous bleeding.

[0005] Bioprosthetic valves are primarily derived from glutaraldehyde-treated porcine or bovine pericardial tissue, whose blood flow characteristics are closer to those of natural human valves, and they typically require only short-term anticoagulation. However, long-term implantation of bioprosthetic tissue can lead to problems such as calcification, wear, and structural failure, resulting in poor durability. Many patients, especially younger ones, may face the risk of needing a second valve replacement surgery.

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

[0007] Therefore, there is an urgent need to develop a novel artificial heart valve structure that can optimize hemodynamic performance and reduce the risks of thrombosis and calcification while ensuring long-term durability. Simultaneously, it should simplify the manufacturing process, improving production efficiency while maintaining normal valve function, making production replicable and quantifiable. Summary of the Invention

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

[0009] (II) Technical Solution: In order to solve the above-mentioned technical problems, this technical solution provides a clamping structure artificial heart valve, including a first valve seat body, a second valve seat body, and an artificial valve leaflet; the second valve seat body is disposed on the outside of the first valve seat body, and the artificial valve leaflet is disposed between the first valve seat body and the second valve seat body;

[0010] The second petal seat body is provided with dividing lines, the midpoint of which intersects the central axis of the second petal seat body, and the dividing lines divide the second petal seat body into two halves.

[0011] The dividing line intersects the central axis of the second petal body at a distance of 20-40 degrees from one of the protruding pillar peaks on the second petal body.

[0012] The first petal seat body has a guide groove on the side facing the artificial petal leaf, and the root of the artificial petal leaf has a protruding ridge that cooperates with the guide groove.

[0013] The width of the inlet end of the guide groove is 1.5-2 times the width of the outlet end.

[0014] The bottom of the guide groove is provided with a wear-resistant coating, which is used to reduce the coefficient of motion friction between the artificial petal leaflet and the first petal seat body.

[0015] A sealing element is provided between the inner wall surfaces of the first and second petal seats. The inner edge of the sealing element is in contact with the outer peripheral surface of the artificial petal leaflet, and the outer edge is fixed to the petal seat body through an annular groove.

[0016] The sealing element has a U-shaped cross-section and an arc-shaped protrusion on its inner edge. The arc-shaped protrusion enables dynamic sealing and flexible buffering between the artificial valve leaflet and the first valve seat body.

[0017] The second petal seat body has a positioning ring fitted on its outer peripheral surface. The positioning ring has a buffer groove on the side opposite to the second petal seat body. The second petal seat body has an elastic boss at the position opposite to the positioning ring. When the elastic boss is placed in the buffer groove, radial fine adjustment is achieved.

[0018] The positioning ring has an anchoring element on its outer circumferential surface, and the anchoring element is barbed.

[0019] The artificial leaflet consists of three identical leaflets of equal size and one covering membrane covering the outer surface of the first valve seat.

[0020] The second petal seat body and the first petal seat body are radially nested together, and a gap is formed between the inner wall of the second petal seat body and the outer wall of the first petal seat body to accommodate the artificial petal leaflet.

[0021] (III) Beneficial Effects: This invention provides a clamping structure artificial heart valve, which uses a tenon-and-mortise structure between the first and second valve seats to fit the artificial valve leaflets, thus realizing the fabrication of the artificial heart valve. This reduces the difficulty of attaching the leaflets to the valve seats, improves the effectiveness and efficiency of the leaflets, enhances the overall symmetry of the artificial valve, and avoids the impact of traditional suturing on the suture edges around the artificial valve leaflets, extending the service life of the artificial heart valve. Furthermore, it ensures the reproducibility and mass production of the overall artificial valve structure, improving production efficiency. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the overall three-dimensional structure of an embodiment of the clamping structure artificial heart valve of the present invention;

[0023] Figure 2 This is a three-dimensional structural schematic diagram of the first valve seat body of an embodiment of a clamping structure artificial heart valve according to the present invention;

[0024] Figure 3 This is a three-dimensional structural schematic diagram of the second valve seat body of an embodiment of a clamping structure artificial heart valve according to the present invention;

[0025] Figure 4 This is a cross-sectional structural schematic diagram of the second valve seat body in one embodiment of the clamping structure artificial heart valve of the present invention;

[0026] Figure 5 This is a three-dimensional structural schematic diagram of the first valve seat body of a second embodiment of the clamping structure artificial heart valve of the present invention;

[0027] Figure 6 This is a cross-sectional schematic diagram of a second embodiment of the clamping structure artificial heart valve of the present invention;

[0028] Figure 7 This is a schematic diagram of the sealing structure of a clamping structure artificial heart valve according to Embodiment 3 of the present invention;

[0029] Figure 8 This is a cross-sectional enlarged structural diagram of a clamping structure artificial heart valve according to a third embodiment of the present invention;

[0030] 100-First petal seat body; 200-Second petal seat body; 201-Second dividing line; 300-Artificial petal leaf; 400-Petal leaf fixing hole; 501-Guide groove; 502-Protruding ridge; 601-Sealing element; 602-Arc-shaped protrusion; 603-First annular groove; 604-Second annular groove. Detailed Implementation

[0031] The present invention will be further described in detail below with reference to preferred embodiments. More details are set forth in the following description in order to provide a full understanding of the present invention. However, the present invention can obviously be implemented in many other ways different from those described herein. Those skilled in the art can make similar extensions and derivations based on actual application situations without departing from the spirit of the present invention. Therefore, the scope of protection of the present invention should not be limited by the content of this specific embodiment.

[0032] 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.

[0033] Example 1

[0034] like Figure 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] When using artificial leaflets 300 of different thicknesses, adjust the inner and outer diameters of the second leaflet body 200 so that the distance between the first leaflet body 100 and the second leaflet body 200 matches the artificial leaflet 300.

[0039] The second petal seat body 200 is provided with a second dividing line 201. The second dividing line 201 divides the second petal seat body 200 into two axisymmetric halves along the diameter of the lower part of the second petal seat body 200. One end of the second dividing line 201 intersects the central axis of one of the protruding column peaks of the second petal seat body 200 at an angle of 20-40 degrees, and the other end passes through the central axis of the second petal seat body 200 and intersects the second petal seat body 200.

[0040] During the movement of the artificial petal, the three raised column peaks on the petal seat body tend to converge towards the center due to the force exerted. Therefore, these areas are not only the main stress points of the petal seat but also the locations where the artificial petal bears the greatest stress. By adjusting the dividing line of the second petal seat body from its original location at the highest point of the raised peaks to one side of the raised peaks, i.e., a relatively lower position, the joint of the assembled petal seat bodies precisely avoids this high-stress area, thereby effectively reducing the risk of structural damage. The petal seat body includes the first petal seat body and the second petal seat body.

[0041] When the first petal seat body 100 and the second petal seat body 200 are combined, the protruding columnar peak of the second petal seat body corresponds to the protruding columnar peak of the first petal seat body, and the second dividing line 201 is formed as a dividing line.

[0042] Both the first petal seat body 100 and the second petal seat body 200 include at least two structural segments: an upper segment and a lower segment. The upper segments of the first petal seat body 100 and the second petal seat body 200 are adapted in shape and size, and the lower segments of the first petal seat body 100 and the second petal seat body 200 are adapted in shape and size, forming the mating foundation of the mortise and tenon structure.

[0043] The upper portion of the first petal seat body 100 is a columnar structure, and its cross-sectional shape and dimensions remain consistent along the axial direction; that is, the inner diameter of the upper portion of the first petal seat body 100 maintains a consistent shape and dimensions along the axial direction. The lower portion of the first petal seat body 100 is an annular base structure; the inner diameter of the upper portion is equal to the inner diameter of the lower portion, and the outer diameter of the lower portion is greater than the outer diameter of the upper portion. Specifically, the cross-section of the upper portion of the first petal seat body 100 has an inner diameter of 21 mm, an outer diameter of 23 mm, a wall thickness of 1 mm, and a height of 9.5 mm; the lower portion of the first petal seat body 100 has an inner diameter of 21 mm, an outer diameter of 26 mm, and a height of 0.3 mm; the overall height of the first petal seat is 11.2 mm.

[0044] The upper portion of the second petal seat body 200 is a columnar structure with varying inner diameters across its cross-sections, which can change along the axial direction according to a predetermined pattern, for example, decreasing in size and then increasing again. The lower portion of the second petal seat body 200 is a hollowed-out annular base structure, and the inner diameter of the upper portion of the second petal seat body 200 matches the inner diameter of the lower portion of the first petal seat body 100. Specifically, the inner diameters of the cross-sections of the upper portion of the second petal seat body 200 are varying, with the smallest cross-section having an inner diameter of 21 mm, the largest cross-section having an inner diameter of 26 mm, an outer diameter of 24.2 mm, a wall thickness of 0.4 mm, and a height of 9.5 mm; the lower portion of the second petal seat body 200 has an inner diameter of 21 mm, an outer diameter of 27.5 mm, and a height of 1.0 mm; the overall height of the second petal seat is 11.5 mm.

[0045] The lower portion of the second petal seat body 200 is provided with a fixing groove, the lower portion of the first petal seat body 100 is fixed in the fixing groove, the edge of the artificial petal leaf 300 is fixed in the fixing groove, and is placed between the lower portion of the second petal seat body 200 and the lower portion of the first petal seat body 100.

[0046] Multiple leaflet fixing holes 400 are respectively provided at the ends where the upper and lower portions of the first leaflet body 100 and the second leaflet body 200 connect. These leaflet fixing holes 400 are evenly distributed at the same horizontal position on the upper portions of both the first leaflet body 100 and the second leaflet body 200. The leaflet fixing holes 400 of the first leaflet body 100 correspond to those of the second leaflet body 200; that is, each leaflet fixing hole 400 of the first leaflet body 100 corresponds to one leaflet fixing hole 400 on the second leaflet body 200. The first leaflet body 100, the second leaflet body 200, and the artificial leaflet 300 are fixed through the leaflet fixing holes 400. Specifically, the first leaflet body 100, the second leaflet body 200, and the artificial leaflet 300 can be sutured together through the leaflet fixing holes 400, thereby achieving a re-fixation of the artificial leaflet 300.

[0047] The first valve seat body 100 and the second valve seat body 200 are made of biocompatible rigid materials, while the artificial valve leaflet 300 is made of biocompatible flexible materials. Specifically, the first valve seat body 100 and the second valve seat body 200 are made of medical implant-grade PEEK material, which must comply with YY / T 0660-2008 and ASTM F2026 standards; the artificial valve leaflet 300 is made of high molecular polymer material, which meets the requirements of biocompatibility, safety, ultra-durability, blood compatibility, and chemical stability.

[0048] Example 2

[0049] An artificial heart valve with a clamping structure 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 columnar structures, with the second valve seat body 200 disposed outside the first valve seat body 100. The two are nested together using a tenon-and-mortise structure. 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.

[0050] The second petal seat body 200 is provided with a second dividing line 201. The second dividing line 201 divides the second petal seat body 200 into two axisymmetric halves along the diameter of the lower part of the second petal seat body 200. One end of the second dividing line 201 intersects the central axis of one of the protruding column peaks of the second petal seat body 200 at an angle of 20-40 degrees, and the other end passes through the central axis of the second petal seat body 200 and intersects the second petal seat body 200.

[0051] When the first petal seat body 100 and the second petal seat body 200 are combined, the protruding columnar peaks of the second petal seat body correspond to the protruding columnar peaks of the first petal seat body, and the second dividing line 201 is thus formed. The dividing line is used to disperse the stress at the point of maximum stress on the petal seat. After assembly, the joint precisely avoids this high-stress area, effectively reducing the risk of structural damage.

[0052] like Figure 5 , Figure 6 As shown, the first petal seat body 100 has a guide groove 501 on the side facing the artificial petal leaf 300, and the root of the artificial petal leaf 300 has a protruding ridge 502 that cooperates with the guide groove 501. The guide groove 501 is used to limit the sliding direction of the protruding ridge 502 on the artificial petal leaf 300, ensuring the stability of the opening and closing angle of the petal leaf. The cooperation between the protruding ridge 502 and the gradually wide guide groove 501 receives the squeezing centering force of the guide groove 501 during the sliding process, driving the petal leaf as a whole to align with the central axis, ensuring that the three petals are accurately spliced ​​when closed, and avoiding sealing failure caused by petal leaf eccentricity.

[0053] Three guide grooves 501 are evenly distributed circumferentially along the surface of the first valve seat body 100 facing the artificial leaflet 300. Each guide groove 501 corresponds to one leaflet of the artificial leaflet 300, meaning the angle between any two adjacent guide grooves 501 is 120°. The guide grooves 501 are non-uniformly wide elongated strips, and their length matches the movement stroke of the leaflet root. Specifically, the guide grooves 501 extend along the central axis of the artificial heart valve from the root of the artificial leaflet 300 towards the protruding column peak, with a length of 5-8 mm. The cross-section of the guide grooves 501 is U-shaped, with its opening facing the artificial leaflet 300, and a depth of 0.6-0.8 mm, preferably 0.7 mm, to ensure that the protruding ridge 502 does not fall out after being embedded.

[0054] The root of the guide groove 501, i.e., the end furthest from the protruding column peak, is the inlet end of the guide groove 501, and the end closest to the protruding column peak is the outlet end of the guide groove 501. The width of the inlet end of the guide groove 501 is 1.5-2 times the width of the outlet end; specifically, the width of the inlet end is 2.5-3 mm, and the width of the outlet end is 1.5-2 mm. The guide groove 501 tapers linearly from the inlet end to the outlet end.

[0055] The guide groove 501 has a linearly tapering cross-section that can also be considered an isosceles trapezoid, with its side walls inclined at an angle of 5°-8°. This means the width of the bottom of the guide groove 501 is greater than the width of the end of the guide groove 501 closest to the artificial petiole 300. The side walls of the guide groove 501 have rounded transitions with a radius R = 0.3 mm to prevent scratching the surface of the protruding ridge 502.

[0056] The protruding ridge 502 corresponds to the guide groove 501. The protruding ridge 502 extends along the axial direction of the artificial heart valve from the root of the artificial leaflet 300 towards the protruding peak. The protruding ridge 502 is integrally formed with the artificial leaflet 300 and is made of the same material as the artificial leaflet 300.

[0057] Three protruding ribs 502 are correspondingly provided with one guide groove 501, one protruding rib 502 corresponding to one guide groove 501. The length of the protruding rib 502 matches the length of the guide groove 501, which is 5-8mm. The cross-section of the protruding rib 502 is semi-circular or rectangular, and the difference between the width of the outlet end and the width of the protruding rib 502 is 0.1-0.2mm to ensure that the protruding rib 502 slides smoothly within the guide groove 501. The height of the protruding rib 502 is 0.5-0.7mm, preferably 0.6mm. Specifically, the height difference between the height of the guide groove 501 and the height of the protruding rib 502 is 0.1mm to ensure that the protruding rib 502 slides smoothly along the guide groove 501. The protruding direction of the protruding rib 502 points towards the opening of the guide groove 501 to ensure natural embedding into the groove. The end of the protruding rib 502 that connects to the artificial petiole 300 is transitioned by an arc with R=0.5mm to avoid stress concentration leading to breakage.

[0058] The bottom of the guide groove 501 is provided with a wear-resistant coating, which is used to reduce the coefficient of motion friction between the artificial petiole 300 and the first petiole seat body 100. Specifically, the wear-resistant coating is provided on the sliding surface of the guide groove 501 that contacts the protrusion 502, and the wear-resistant coating is continuously and uniformly distributed within 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.

[0059] The wear-resistant coating is made of polytetrafluoroethylene (PTFE), which has an extremely low coefficient of friction, wear resistance and biocompatibility, with a static coefficient of friction of 0.04-0.05, a wear rate of <0.01mm³ / (N·m), and no immune reaction.

[0060] The wear-resistant coating reduces the wear rate between the protrusion 502 and the guide groove 501, preventing the groove width from increasing and the protrusion 502 from becoming thinner due to long-term friction, thereby extending the service life of the artificial valve to more than 20 years.

[0061] The gradually wide guide groove 501 guides the artificial leaflet to automatically center during opening and closing, reducing eccentric wear; the wear-resistant coating reduces the coefficient of friction of the leaflet movement by more than 40%, extending the service life of the valve.

[0062] The wear-resistant coating is applied using a plasma spraying process, with a bonding strength ≥5MPa, preventing it from peeling off.

[0063] The surface of the wear-resistant coating can also be laser-microstructured to form micron-sized pits with a diameter of 5-10 μm and a depth of 1-2 μm. These pits can store a small amount of body fluid as a lubricating medium, further reducing friction and significantly improving the overall smoothness.

[0064] When the heart contracts and blood pushes the artificial valve leaflet 300 open, the protruding ridge 502 slides along the guide groove 501 from the outlet end to the inlet end, that is, from the narrow opening to the wide opening. Because the inlet end is wide, even if the artificial valve leaflet 300 is slightly laterally offset due to the impact of blood flow, such as deviating to the left by 0.3mm, the protruding ridge 502 can still slide smoothly to the inlet end of the guide groove 501.

[0065] When the heart relaxes and the artificial valve leaflet 300 closes: the protrusion 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 protrusion 502 will be squeezed towards the center by the gradually narrowing groove wall, and finally accurately inserted into the outlet end, ensuring that the artificial valve leaflet 300 is in the center position every time it closes, avoiding eccentric wear.

[0066] Example 3

[0067] A sealing element 601 is provided between the inner wall surfaces of the first valve seat body 100 and the second valve seat body 200. The inner edge of the sealing element 601 is in contact with the outer peripheral surface of the artificial valve leaflet 300, and the outer edge is fixed to the valve seat body through an annular groove.

[0068] The sealing element 601 is an annular elastic sealing element 601, such as... Figure 7As shown, the sealing element 601 is made of a double-layer composite material of silicone rubber and polytetrafluoroethylene. The inner layer is medical-grade silicone rubber with a thickness of 0.3-0.5 mm and a Shore A hardness of 50-60, providing elastic deformation capability for the sealing element 601. The outer layer is a polytetrafluoroethylene film with a thickness of 0.05-0.1 mm. Alternatively, the outer layer can be described as a film covering the inner layer surface. The sealing element 601 has a U-shaped groove structure in cross-section, with its 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 element 601 are: compressive modulus of 1.5-2 MPa, elongation at break ≥300%, capable of withstanding 100,000 cycles of reciprocating deformation per day without permanent deformation, meeting the opening and closing frequency of the heart valve.

[0069] The sealing element 601 is located vertically on the central axis at the root of the artificial leaflet 300. Preferably, the sealing element 601 is positioned vertically above the leaflet fixing hole 400. When the first leaflet seat is provided with a guide groove 501, the sealing element 601 is positioned vertically between the leaflet fixing hole 400 and the guide groove 501.

[0070] like Figure 8 As shown, the annular groove includes a first annular groove 603 disposed on the outer side wall of the first petal seat body 100 and a second annular groove 604 disposed on the inner side wall of the second petal seat body 200. The first annular groove 603 and the second annular groove 604 are coaxially aligned to form an annular groove. The cross-section of the annular groove is an inverted trapezoid, that is, the opening of the annular groove is wide and the bottom is narrow. The width of the opening is 1.2-1.5mm, the width of the bottom is 0.8-1mm, and the depth is 0.5-0.8mm. The inner wall of the groove is provided with a 0.1mm deep serrated anti-slip texture.

[0071] The outer edges of the sealing element 601 at both radial ends are respectively embedded in the annular grooves. Specifically, the end of the sealing element 601 near the first valve seat body 100 is embedded in the first annular groove 603, and the end near the second valve seat body 200 is embedded in the second annular groove 604. The sealing element 601 and the annular groove are mechanically fixed by an interference fit, with an interference amount of 0.1-0.2 mm. The end of the annular groove away from the sealing element 601 is the bottom of the annular groove. Medical-grade silicone rubber adhesive can also be applied to the bottom of the annular groove to bond the sealing element 601 to the annular groove, thereby enhancing its long-term stability.

[0072] The annular groove corresponds to the seal 601 in the vertical direction. When the artificial heart valve is assembled, both ends of the seal 601 are placed in the annular groove to ensure that the seal 601 is axially limited and cannot slide along the valve seat body.

[0073] The sealing element 601 has an arc-shaped protrusion 602 near the inner edge of the first valve seat body 100, which is adapted to the movement trajectory of the artificial valve leaflet 300. Figure 8 As shown, the arc-shaped protrusion 602 achieves dynamic sealing and flexible buffering between the artificial leaflet 300 and the first valve seat body 100.

[0074] The arc-shaped protrusion 602 is a continuous annular protrusion located on the inner edge of the sealing member 601 near the first valve seat body 100. The arc-shaped protrusion 602 is integrally formed along the inner circumferential surface of the sealing member 601. The arc-shaped protrusion 602 has a semi-circular cross-section, a height of 0.3-0.5 mm, an arc radius of 0.2-0.3 mm, and a top width of 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.

[0075] The arc-shaped protrusion 602 can be made of medical-grade silicone rubber. The end of the arc-shaped protrusion 602 connected to the seal 601 is transitioned to the seal 601 through a 0.1mm thick flexible connecting section. The arc-shaped protrusion 602 allows for an elastic deformation of ±0.2mm in the radial direction to adapt to the change in the curvature of the outer circumference when the leaflet opens and closes.

[0076] The arc-shaped protrusion 602 is located in the upper 1 / 3 region of the inner edge of the sealing member 601 near the first valve seat body 100, that is, in the 1 / 3 region near the free end of the artificial valve leaflet 300, corresponding to the dynamic contact area of ​​the outer peripheral surface of the artificial valve leaflet 300. When the artificial valve leaflet 300 is completely closed, the arc-shaped protrusion 602 contacts the outer peripheral surface of the artificial valve leaflet 300 near the middle; when the artificial valve leaflet 300 is opened to the maximum angle of about 85°, the arc-shaped protrusion 602 contacts the outer peripheral surface of the artificial valve leaflet 300 near the root, forming a full-stroke seal.

[0077] The specific fit between the sealing element 601 and the annular groove is as follows:

[0078] When the artificial valve leaflet 300 is in the closed state, it is in a static seal. The outer circumferential surface of the artificial valve leaflet 300 is approximately cylindrical. The arc-shaped protrusion 602, under the elastic force of the silicone rubber, tightly adheres to the outer circumferential surface of the artificial valve leaflet 300, forming the first sealing line. The U-shaped groove structure of the sealing element 601 expands radially due to the leaflet compression, and its outer edge is embedded in the annular groove. The mechanical limiting and anti-slip texture of the inverted trapezoidal groove of the annular groove prevent the axial displacement of the sealing element 601. At this time, the annular groove fixes the position of the sealing element 601, and the arc-shaped protrusion 602 eliminates the microscopic gap of ≤0.05mm between the artificial valve leaflet 300 and the sealing element 601, blocking blood leakage from the root of the artificial valve leaflet 300.

[0079] When the artificial valve leaflet 300 is in the opening and closing process, it is in a dynamic sealing state. During the opening phase of the artificial valve leaflet 300: when the left ventricle contracts and blood pushes the artificial valve leaflet 300 open, the curvature of the outer circumference of the artificial valve leaflet 300 gradually changes from cylindrical to trumpet-shaped, and the maximum outer diameter increases. At this time, the arc-shaped protrusion 602 is elastically compressed by the artificial valve leaflet 300, and the flexible connecting section bends, ensuring that the arc-shaped protrusion 602 always maintains surface contact with the outer circumference of the artificial valve leaflet 300. The inner wall of the U-shaped groove of the sealing member 601 is stretched outward, and the elasticity of the silicone rubber layer... The elastic recovery force maintains the contact pressure; during the closing phase of the artificial valve leaflet 300: the left ventricle is in diastole, the artificial valve leaflet 300 closes under blood flow pressure, the curvature of the outer peripheral surface of the artificial valve leaflet 300 decreases, and the arc-shaped protrusion 602 rises again due to elastic recovery, fitting the outer peripheral surface of the artificial valve leaflet 300 after contraction. At the same time, the U-shaped groove of the sealing member 601 elastically contracts, and the outer edge slightly rebounds in the annular groove, ensuring that the interference fit between the sealing member 601 and the annular groove does not loosen.

[0080] Example 4

[0081] A positioning ring is fitted on the outer peripheral surface of the second petal seat body 200. A buffer groove is provided on the side of the positioning ring opposite to the second petal seat body 200. An elastic boss is provided at the position opposite to the positioning ring. When the elastic boss is placed in the buffer groove, radial fine adjustment and interference locking are realized.

[0082] The positioning ring is coaxially sleeved on the lower middle outer circumferential surface of the second valve seat body 200, covering 1 / 3 of the height of the second valve seat body 200 from the base upwards, and located below the joint between the artificial valve leaflet 300 and the valve seat body, so as to avoid interfering with the opening and closing movement of the artificial valve leaflet 300.

[0083] The positioning ring is a thin-walled annular structure made of nickel-titanium shape memory alloy, exhibiting superelasticity and shape memory effect. Superelasticity refers to a strain of up to 8%, and shape memory effect refers to the ability to recover a 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, and the inner diameter is 0.1-0.3 mm larger than the outer diameter of the second lobe body 200, forming a radial fine-tuning gap.

[0084] The positioning ring has three evenly distributed guide grooves along its inner circumferential surface. The guide grooves are 0.5 mm wide and 0.2 mm deep. The second petal seat body 200 has three guide ribs on its outer circumferential surface. The guide ribs cooperate with the guide grooves to restrict the circumferential rotation of the positioning ring and allow only radial movement.

[0085] The surface of the positioning ring is treated with electrolytic polishing and titanium nitride coating, with a roughness Ra≤0.8μm, which reduces blood flow resistance and the risk of thrombosis.

[0086] The elastic boss is located at the axial center of the outer circumferential surface of the second petal seat body 200, and cooperates with the buffer groove on the inner circumferential surface of the positioning ring. When the elastic boss is finely adjusted radially, it can slide along the buffer groove, and after fine adjustment, it is embedded in the buffer groove to achieve interference locking.

[0087] Three elastic protrusions are evenly distributed circumferentially along the outer periphery of the second valve seat body 200, and the included angle between adjacent elastic protrusions is 120°. The elastic protrusions are integrally injection molded from medical-grade silicone rubber and are mechanically connected to the positioning ring through an embedded connection, that is, the elastic protrusions are embedded in the buffer groove of the inner wall of the positioning ring.

[0088] The elastic boss is a hemispherical protrusion with a rounded top to avoid stress concentration. A miniature nickel-titanium alloy spring wire is embedded inside the elastic boss to improve its elastic recovery performance; when compressed by 0.2 mm, the recovery force is 2-3 N.

[0089] Specifically, the elastic boss is located on the side or top surface of the guide rib away from the positioning ring, and is embedded in the guide groove along with the guide rib.

[0090] The elastic boss is an integrated protrusion of the guide rib, typically located on both circumferential sides or the radial outer surface of the guide rib. The height of the elastic boss is less than the overall height of the guide rib, and its width is less than the width of the guide rib. The elastic bosses are distributed along the entire axial length of the guide rib or at intervals in critical stress areas, such as the middle and both ends.

[0091] The buffer groove is opened on the groove wall or bottom of the guide slide away from the second petal seat body 200, and is precisely aligned with the elastic boss.

[0092] The elastic boss and the buffer groove are substructures that cooperate with the guide rib and the guide groove, and their positions are completely dependent on the guide rib and the guide groove. The elastic boss is embedded into the guide groove along with the guide rib.

[0093] The buffer groove is a partially deepened or widened structure of the guide groove. Its location, shape, and size strictly correspond to the elastic boss: if the elastic boss is on the side of the guide rib, the buffer groove is opened on the groove wall of the guide groove; if the elastic boss is on the top surface of the guide rib, the buffer groove is opened at the bottom of the guide groove; the width and depth of the buffer groove are slightly larger than the elastic boss to ensure that the elastic boss can be fully embedded and retain elastic deformation space, and the axial distribution range completely coincides with the boss.

[0094] The outer circumferential surface of the positioning ring is provided with anchoring elements, which are barbed. The anchoring elements are located at both axial ends of the outer circumferential surface of the positioning ring, 1 mm from the upper and lower edges of the positioning ring, forming upper and lower anchoring arrays. The upper ring of anchoring elements points towards the valve inflow tract, i.e., upstream of blood flow, while the lower ring of barbs points towards the outflow tract, ensuring bidirectional anti-dislocation during the cardiac systolic / diastolic cycle.

[0095] The anchoring elements are evenly distributed in three groups along the outer circumferential surface of the positioning ring. Each group includes 2-3 anchoring elements, spaced 30° apart in the circumferential direction.

[0096] The barbed anchor has an isosceles triangular sheet structure, specifically with a base length of 0.5 mm, a height of 0.3 mm, and a tip angle of 30°. The surface of the anchor is passivated to avoid excessive damage when it penetrates the tissue. The barb base is 0.1 mm thick and has unidirectional elastic deformation capability. It can bend axially along the implantation direction, with a maximum bending angle of 45°. In the opposite direction, it provides rigid support radially outward to prevent the positioning ring from shifting centripetally.

[0097] The above structure enables radial fine-tuning during implantation:

[0098] In the initial state, the positioning ring forms a pre-tight interference fit with the second lobe seat body 200 through the elastic boss. At this time, the radial clearance is partially offset, and the positioning ring is in a centered and ready-to-adjust state.

[0099] When an artificial heart valve is implanted into a patient's heart valve ring, if there is a dimensional deviation of ±0.2mm between the valve ring diameter and the second valve seat body 200, the positioning ring, under external compressive force, such as the pushing force of surgical instruments or the pressure of myocardial tissue, slides radially through the cooperation of the guide groove and the guide rib. The elastic boss is further compressed or rebounded, and adaptive compensation is achieved by using a gap of 0.1~0.3mm. For example, if the valve ring diameter is too large, the positioning ring slides outward to the maximum gap; if it is too small, it slides inward.

[0100] Once adjusted, 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 radial displacement, ensuring that the valve maintains a stable position during cardiac motion.

[0101] After the positioning ring is finely adjusted into place, the anchor on the outer circumference is fixed under the action of surgical pushing force to prevent the positioning ring from axial or radial displacement caused by cardiac contraction / diastole.

[0102] A clamping structure artificial heart valve forms a gap to accommodate the artificial valve leaflet through the radial nesting of the first valve seat body and the second valve seat body. The leaflet is fitted with a tenon and mortise structure, which avoids damage to the leaflet edge caused by traditional suturing, reduces stress concentration at the suture edge, and extends the service life of the valve.

[0103] The design of the dividing line between the first and second lobe bodies intersects the central axis of the protruding column peak at 30° to 60°, which disperses the load in the high-stress area. After splicing, the joint avoids the key stress points, reducing the risk of structural damage.

[0104] The seal features a U-shaped cross-section design, with the arc-shaped protrusion on the inner edge dynamically fitting the outer circumferential surface of the artificial valve leaflet to achieve a seal throughout the heart's systolic and diastolic processes, preventing blood leakage from the valve leaflet root.

[0105] The inner silicone rubber layer of the seal provides elastic deformation capability, while the outer polytetrafluoroethylene film reduces frictional damage, thus meeting the long-term opening and closing requirements of the heart valve.

[0106] The guide groove of the first petal seat body cooperates with the protruding ridge at the root of the petal leaf. When the petal leaf is closed, it automatically centers through the gradient width design to ensure that the three petals are accurately spliced ​​and avoid sealing failure and local wear caused by eccentricity.

[0107] The PTFE wear-resistant coating on the bottom of the guide groove reduces the coefficient of motion friction by more than 40%, and combined with the laser-structured micro-pits for storing body fluid lubrication, it significantly extends the valve's service life to more than 20 years.

[0108] Artificial valve leaflets consist of three equally sized polymer leaflets and a covering membrane. They have a stable opening angle, with a maximum opening angle of about 85°. Their hemodynamic performance is close to that of natural valves, reducing blood stasis and the risk of thrombosis.

[0109] The positioning ring is made of nickel-titanium shape memory alloy and its surface is treated with titanium nitride coating to reduce blood flow resistance; the barbed anchors provide bidirectional anti-dislocation protection in the inflow / outflow tract after implantation, improving long-term stability;

[0110] The interlocking design of the valve seat and leaflet simplifies the manufacturing process, avoids damage to the leaflet performance caused by suturing operations, and improves production efficiency.

[0111] Structural parameters can be quantified and controlled to ensure product consistency and replicability, meeting the needs of large-scale production;

[0112] The first and second valve seats are made of medical-grade PEEK material, and the artificial valve leaflets are made of biocompatible polymers. The material combination takes into account both rigid support and flexible movement requirements, while reducing the risk of calcification.

[0113] The positioning ring's elastic boss and buffer groove interference-lock design allow for radial micro-adjustment of ±0.2mm, adapting to different patients' valve ring size deviations and improving the success rate of surgical implantation; the positioning ring's hyperelasticity and shape memory effect can adapt to the periodic motion of the heart, reducing mechanical stimulation to surrounding tissues.

[0114] By reducing the risk of thrombosis, calcification, and structural failure, it lowers the probability of secondary surgery for younger patients, and compared to mechanical valves, it does not require lifelong anticoagulation therapy, thus improving patients' quality of life.

[0115] This invention achieves triple optimization of durability, hemodynamics, and production efficiency through seamless interlocking design, dynamic sealing system, precise guidance mechanism, and modular manufacturing process, providing a novel treatment option for patients with valvular heart disease that combines long-term safety and clinical feasibility.

[0116] The above description illustrates preferred embodiments of the present invention and helps those skilled in the art to more fully understand the technical solution of the present invention. However, these embodiments are merely illustrative and should not be construed as limiting the specific implementation of the present invention to these embodiments. For those skilled in the art, several simple deductions and modifications can be made without departing from the inventive concept, and all such modifications should be considered within the protection scope of the present invention.

Claims

1. A clamped structure prosthetic heart valve, characterized by, The artificial heart valve comprises a first valve seat body, a second valve seat body and artificial valve leaflets; the second valve seat body is arranged outside the first valve seat body, and the artificial valve leaflets are 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; One side of the first valve seat body facing the artificial valve leaflets is provided with a guide groove, the root of the artificial valve leaflet is provided with a convex rib matched with the guide groove, the inlet end to the outlet end of the guide groove is linearly tapered and narrowed, the guide groove is used for limiting the sliding direction of the convex rib on the artificial valve leaflet, and the matching of the convex rib and the guide groove with a tapered width receives the centering force of extrusion of the guide groove in the sliding process, so as to align the artificial valve leaflet as a whole to the central axis.

2. The clamped structure prosthetic heart valve of claim 1, wherein, The split line intersects with one side of the convex column peak of the second valve seat body at an angle of 20-40 degrees, respectively, and intersects with the central axis of the second valve seat body.

3. The clamped structure prosthetic heart valve of claim 1, wherein, The guide grooves are uniformly distributed along the surface of the side of the first valve seat body facing the artificial valve leaflets, and there are three guide grooves, each corresponding to one artificial valve leaflet, that is, the angle between every two adjacent guide grooves (501) is 120°. The guide groove is a non-equal-width long strip, the groove length of the guide groove matches the movement stroke of the valve leaflet root, that is, the guide groove extends from the root of the artificial valve leaflet to the convex column peak along the central axis of the artificial heart valve, and the cross section of the guide groove is U-shaped, and the opening of the guide groove faces the artificial valve leaflet.

4. The clamped structure prosthetic heart valve of claim 1, wherein, The root of the guide groove, that is, the end away from the convex column peak, is the inlet end of the guide groove, and the end close to the convex column peak is the outlet end of the guide groove, and the width of the inlet end of the guide groove is 1.5-2 times the width of the outlet end.

5. The clamped structure prosthetic heart valve of claim 1, wherein, The cross section of the guide groove is linearly tapered and narrowed from the inlet end to the outlet end, and is isosceles trapezoidal, and the inclination angle of the two side walls is 5-8°, that is, the groove bottom width of the guide groove is greater than the width of the end of the guide groove close to the artificial valve leaflet, and the two side walls of the guide groove are circularly transitioned.

6. The clamped structure prosthetic heart valve of claim 1, wherein, The convex rib and the guide groove correspond to each other, and the convex rib extends from the root of the artificial valve leaflet to the convex column peak along the axial direction of the artificial heart valve. The cross section of the convex rib is semicircular or rectangular, the difference between the width of the outlet end and the width of the convex rib is 0.1-0.2 mm, the difference between the height of the guide groove and the height of the convex rib is 0.1 mm, the convex direction of the convex rib points to the opening of the guide groove, and the end of the convex rib connected with the artificial valve leaflet is provided with a circular transition.

7. The clamped structure prosthetic heart valve of claim 1, wherein, The groove bottom of the guide groove is provided with a wear-resistant coating, and the wear-resistant coating is used to reduce the movement friction coefficient between the artificial valve leaflet and the first valve seat body.

8. The clamped structure prosthetic heart valve of claim 7, wherein, The surface of the wear-resistant coating is microstructured by laser, so that micron-level pits with a diameter of 5-10 μm and a depth of 1-2 μm are formed on the surface of the wear-resistant coating, a small amount of body fluid is stored in the pits as a lubricating medium, and the friction is reduced.

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

10. The clamped structure prosthetic heart valve of claim 9, wherein, The cross section of the sealing element is U-shaped, and the inner 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.

11. The clamped structure prosthetic heart valve of claim 1, wherein, The outer circumferential surface of the second valve seat body is sleeved with a positioning ring, the opposite surface 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.

12. The clamped structure prosthetic heart valve of claim 11, wherein, The outer circumferential surface of the positioning ring is provided with an anchor, which is barb-shaped.

13. 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 covering the outer surface of the first valve seat body.

14. 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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