Artificial heart valve with mortise and tenon joint structure

Abstract

An artificial heart valve with a mortise and tenon joint structure comprises a first valve seat body, a second valve seat body and an artificial valve leaflet. The second petal seat body is arranged on the outer side of the first petal seat body, and the second petal seat body and the first petal seat body are combined together in a nested mode through a mortise and tenon joint structure. The artificial valve leaflet is arranged between the first valve seat body and the second valve seat body. The artificial valve leaflet is embedded between the first valve seat and the second valve seat, the first valve seat and the second valve seat are combined together to form a mortise and tenon joint structure, the valve leaflet fixing hole is formed in the connecting position of the upper part and the lower part of the valve seat, the artificial valve leaflet is embedded through the mortise and tenon joint effect of the valve leaflet fixing hole, and preparation of the artificial heart valve is achieved; the problems that due to the fact that an existing heart valve prosthesis interferes with a valve leaflet suture part, errors exist in symmetry of the whole structure of the artificial valve, and a finished product is difficult to re-engrave are solved, stress uniformity of the artificial valve leaflet is guaranteed by fixing the artificial valve leaflet to the bottom of a valve seat, and the medical burden of a patient is greatly relieved.

Description

Technical Field

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

[0002] Artificial heart valves are key medical devices for treating heart valve diseases, such as stenosis or regurgitation. Their function is to replace diseased valves and restore normal hemodynamic performance.

[0003] Currently, artificial heart valves are mainly divided into two categories: mechanical valves and bioprosthetic valves, but both have certain limitations: Mechanical valves are usually made of metals such as titanium alloys or carbon materials and have a long service life, sometimes up to 20 years or more. However, patients need to take anticoagulants for life to avoid thrombosis, which increases the risk of bleeding and treatment costs. Bioprosthetic valves are mainly made from biological tissues such as porcine or bovine pericardium, which are cross-linked with glutaraldehyde. Their hemodynamic properties are closer to those of natural valves, and the postoperative anticoagulation treatment period is shorter. However, bioprosthetic valves have poor durability and are prone to calcification, tearing, or deterioration after long-term use, leading to the need for a second surgery to replace the valve, which has a greater impact on young patients.

[0004] In recent years, polymer artificial heart valves have attracted attention due to their good flexibility and antithrombotic properties. However, they still face problems such as artificial suturing intervention and uneven impregnation during the manufacturing process, which directly affect hemodynamic performance and durability. Existing designs are prone to wear or deformation under long-term cyclic loads.

[0005] 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

[0006] (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 safer and more reliable artificial heart valve.

[0007] (II) Technical Solution: In order to solve the above-mentioned technical problems, this technical solution provides a mortise and tenon 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 two are nested together by a mortise and tenon structure; the artificial valve leaflet is disposed between the first valve seat body and the second valve seat body.

[0008] The aforementioned mortise and tenon structure artificial heart valve, wherein the artificial valve leaflet is composed of three equal and identical leaflets and a covering membrane covering the outer surface of the first valve seat.

[0009] In the aforementioned mortise and tenon structure artificial heart valve, the second valve seat body and the first valve seat body are radially nested together, and a gap is formed between the inner wall of the second valve seat body and the outer wall of the first valve seat body to accommodate the artificial valve leaflet.

[0010] The aforementioned mortise and tenon structure artificial heart valve, wherein both the first valve seat body and the second valve seat body include at least two structural segments, an upper segment and a lower segment, wherein the upper segment of the first valve seat body and the upper segment of the second valve seat body are adapted in shape and size, and the lower segment of the first valve seat body and the lower segment of the second valve seat body are adapted in shape and size.

[0011] The aforementioned mortise and tenon structure artificial heart valve, wherein the upper portion of the first valve seat body is a columnar structure, and the shape and size of its cross-section remain consistent along the axial direction; the lower portion of the first valve seat body is a circular annular base structure; the outer diameter of the lower portion is larger than the outer diameter of the upper portion.

[0012] In the aforementioned mortise and tenon structure artificial heart valve, the upper portion of the second valve seat body is a hollow columnar structure, the inner diameter of its cross-section changing in a predetermined pattern along the axial direction; the lower portion of the second valve seat body is a hollow annular structure; the inner diameter of the upper portion of the second valve seat body is adapted to the inner diameter of the lower portion of the first valve seat body.

[0013] In the aforementioned mortise and tenon structure artificial heart valve, the lower portions of the first valve seat body and the second valve seat body are both smooth arc-shaped structures, and the upper portions are each provided with three circumferentially evenly distributed protruding column peaks, with each protruding column peak having the same shape and size.

[0014] In the aforementioned mortise and tenon structure artificial heart valve, the lower portion of the second valve seat body is provided with a fixing groove, the lower portion of the first valve seat body is fixed in the fixing groove, and the edge of the artificial valve leaflet is fixed in the fixing groove and placed between the lower portion of the second valve seat body and the lower portion of the first valve seat body.

[0015] In the aforementioned mortise and tenon structure artificial heart valve, a plurality of leaflet fixing holes are respectively provided at the end where the upper and lower portions of the first valve seat body and the second valve seat body are connected. The leaflet fixing holes are evenly distributed at the same horizontal position on the upper portions of the first valve seat body and the second valve seat body. The leaflet fixing holes of the first valve seat body correspond to each other, that is, each leaflet fixing hole of the first valve seat body corresponds to one leaflet fixing hole on the second valve seat body.

[0016] The aforementioned mortise and tenon structure artificial heart valve, wherein the first valve seat body and the second valve seat body are made of biocompatible rigid material, and the artificial valve leaflet is made of biocompatible flexible material.

[0017] (III) Beneficial Effects: This invention provides a mortise and tenon structure artificial heart valve in which the artificial valve leaflet is fitted between the first valve seat and the second valve seat. The first valve seat and the second valve seat are combined to form a mortise and tenon structure. In addition, a leaflet fixing hole is set at the position where the upper and lower parts of the valve seat are connected. The artificial valve leaflet is fitted through its mortise and tenon effect to realize the preparation of the artificial heart valve. This solves the problem that the existing artificial heart valve interferes with the leaflet suturing part, causing errors in the symmetry of the overall structure of the artificial valve, and the difficulty in replicating the finished product. By fixing the artificial valve leaflet to the bottom of the valve seat, the stress of the artificial valve leaflet is ensured to be uniform, and the medical burden on patients is greatly reduced. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of a three-dimensional artificial heart valve with a tenon and mortise structure according to the present invention; Figure 2 This is a three-dimensional structural schematic diagram of the first valve seat body of a tenon-and-mortise structure artificial heart valve according to the present invention. Figure 3 This is a three-dimensional structural schematic diagram of the second valve seat body of an artificial heart valve with a tenon and mortise structure according to the present invention. Figure 4 This is a schematic diagram of the cross-sectional structure of the second valve seat body of an artificial heart valve with a tenon and mortise structure according to the present invention. Figure 5 This is a three-dimensional structural schematic diagram of the artificial leaflet of a tenon-and-mortise structure artificial heart valve according to the present invention. Figure 6 This is a schematic diagram of the buffer layer of a tenon-and-mortise structure artificial heart valve according to the present invention; Figure 7 This is a schematic diagram of the microgroove projection structure of the mortise and tenon structure artificial heart valve buffer layer of the present invention; Figure 8 This is a schematic diagram of the cross-sectional structure of the arc-shaped spring plate of an artificial heart valve with a tenon and mortise structure according to the present invention; 100 - First petal seat body; 200 - Second petal seat body; 300 - Artificial petal leaf; 400 - Buffer layer; 500 - Micro groove; 600 - Arc-shaped spring piece; 700 - Barb. Detailed Implementation

[0019] 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.

[0020] 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.

[0021] A type of artificial heart valve with a mortise and tenon structure, such as Figure 1 As shown, the device includes a first petal seat body 100, a second petal seat body 200, and an artificial petal leaflet 300. The first and second petal seat bodies 200 have a columnar structure, with the second petal seat body 200 disposed outside the first petal seat body 100. The two are nested together using a mortise and tenon joint. The artificial petal leaflet 300 is disposed between the first petal seat body 100 and the second petal seat body 200. The second petal seat body 200 and the first petal seat body 100 are radially nested together, and a gap is formed between the inner wall of the second petal seat body 200 and the outer wall of the first petal seat body 100 to accommodate the artificial petal leaflet 300.

[0022] like Figure 5 As shown, the artificial leaflet 300 consists of three identical leaflets of equal size and one covering film covering 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 22.6 mm, a height of 10.5 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 21 mm, an outer diameter of 22.6 mm, a height of 12.2 mm, and a thickness of 0.2 mm.

[0023] The artificial petal leaflet 300 is produced using a film-layout process. First, a polymer material is formed into a sheet-like solid with uniform thickness. Then, the two-dimensional outline of the artificial petal leaflet 300 is precisely cut using laser cutting. This outline is then fitted between two layers of petal seats, namely the first petal seat body 100 and the second petal seat body 200, forming a petal leaflet with a three-dimensional structure. After molding, the artificial petal leaflet 300 is ready for use after being set in an incubator, effectively avoiding the adverse effects that high temperatures and cooling during injection molding may have on the properties of the polymer material.

[0024] In the film-laying process, solution casting, hot calendering, or online thickness monitoring are used to ensure uniform thickness of the polymer sheet solid.

[0025] Solution casting: The polymer is dissolved in a suitable solvent to form a homogeneous solution, which is then cast onto a flat substrate using a precision coating head to form a film. The solvent is then slowly evaporated under controlled temperature and humidity conditions. The film thickness can be precisely controlled by adjusting parameters such as solution concentration, coating speed, and doctor blade gap.

[0026] Hot calendering: After melting thermoplastic polymer particles, they are calendered into a film through one or more pairs of high-precision temperature-controlled rollers. The roller gap, temperature, pressure, and traction speed can all be digitally controlled, thereby obtaining uniform films with micron-level thickness tolerances.

[0027] Online thickness monitoring: Non-contact thickness gauges, such as beta-ray, infrared, or laser thickness measurement systems, are used to monitor the film thickness in real time and provide feedback to adjust process parameters, thereby achieving closed-loop control.

[0028] The two-dimensional contour of the artificial leaflet 300 was constructed using modeling software to generate a CAD model, which was then directly imported into the laser cutting machine's control system to automatically plan the cutting path. The laser cutting machine's control system employs a picosecond / femtosecond laser or a carbon dioxide laser, precisely controlling the spot size and optimizing key parameters such as laser power, scanning speed, and pulse frequency through experimental optimization. Simultaneously, a high-resolution CCD camera is equipped for material edge recognition or precise positioning of marker points, ensuring clean cutting edges while minimizing carbonization or burrs, achieving fine cutting of polymer materials, and avoiding melting or deformation caused by thermal effects.

[0029] The three-dimensional configuration of the artificial leaflet 300 is guided by the leaflet seat structure: the laser-cut planar artificial leaflet is precisely embedded into the pre-designed inner and outer leaflet seats, that is, the specific gap structure between the first leaflet seat body 100 and the second leaflet seat body 200. The leaflet seat itself has a preset curvature and spatial layout, such as the 120° symmetrical distribution of the three leaflets. When the artificial leaflet is clamped and fixed, it is naturally stretched or bent into the required three-dimensional curved surface shape.

[0030] 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 raised column peaks evenly distributed along the circumference, with each raised column peak having the same shape and size.

[0031] 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 10.5 mm, and each raised columnar peak structure has the same geometric shape. The second petal seat body 200 is located 0.2 mm radially outward from 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.

[0032] The second petal seat body 200 is provided with a second dividing line. The second dividing line 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 intersects the central axis of one of the protruding column peaks of the second petal seat body 200, and the other end intersects the junction point of the remaining two protruding column peaks.

[0033] 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.

[0034] like Figure 2 As shown, 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 22.2 mm, a wall thickness of 0.6 mm, and a height of 11.9 mm; the lower portion of the first petal seat body 100 has an inner diameter of 21 mm, an outer diameter of 24 mm, and a height of 0.3 mm; the overall height of the first petal seat is 12.2 mm.

[0035] like Figure 3As shown, the upper portion of the second petal seat body 200 is a hollow columnar structure, and the inner diameter of its cross-section changes along the axial direction according to a predetermined pattern, specifically, it can be from large to small and then large again. The lower portion of the second petal seat body 200 is a hollow circular 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 different, with the smallest cross-section having an inner diameter of 21 mm, the largest cross-section having an inner diameter of 22.6 mm, an outer diameter of 23.4 mm, a wall thickness of 0.4 mm, and a height of 12.2 mm; the lower portion of the second petal seat body 200 has an inner diameter of 21 mm, an outer diameter of 26 mm, and a height of 1.0 mm; the overall height of the second petal seat is 13.2 mm.

[0036] The lower portion of the second petal seat body 200 is provided with a fixing groove, such as... Figure 4 As shown, the lower portion of the first petal seat body 100 is fixed in the fixing groove, and the edge of the artificial petal leaf 300 is fixed in the fixing groove and placed between the lower portion of the second petal seat body 200 and the lower portion of the first petal seat body 100.

[0037] Multiple leaflet fixing holes 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 fixing holes are evenly distributed at the same horizontal position on the upper portions of both bodies. The leaflet fixing holes of the first leaflet body 100 correspond to those of the second leaflet body 200; that is, each leaflet fixing hole of the first leaflet body 100 corresponds to one leaflet fixing hole on the second leaflet body 200. The first leaflet body 100 and the second leaflet body 200 directly fix the leaflets using a mortise and tenon joint structure, meaning the artificial leaflet 300 is fixed between the first leaflet body 100 and the second leaflet body 200. The second leaflet body 200 serves both structural support and connection functions, directly fixing the artificial leaflet 300 through a mortise and tenon joint structure, eliminating the need for sewing and significantly reducing or even avoiding the uncertainties and quality fluctuations caused by manual operation. After the leaflets and frame have been fitted and their shape fixed, 2-3 stitches are added through the leaflet fixing holes for reinforcement to improve overall stability. This operation does not affect the quality of the leaflets themselves and, since reinforcement is achieved through fixing the leaflets in the fixing holes, it avoids the inconsistencies that can occur with manual sewing. The first leaflet seat body 100, the second leaflet seat body 200, and the artificial leaflet 300 can also be further fixed through the leaflet fixing holes. Specifically, this secondary fixation can be achieved by sewing the first leaflet seat body 100, the second leaflet seat body 200, and the artificial leaflet 300 through the leaflet fixing holes, thereby re-fixing the artificial leaflet 300.

[0038] 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 valve leaflet is made of high molecular polymer material, which meets the requirements of biocompatibility, safety, ultra-durability, blood compatibility, and chemical stability.

[0039] The second petal seat body 200 has a pressure strip at one end where the protruding column peak is provided. The pressure strip extends toward the center of the second petal seat body 200, that is, toward the first petal seat body 100.

[0040] A buffer layer 400 is provided at the top of the protruding column peak of the first valve seat body 100. The buffer layer 400 is used to block the stress transmission path when the artificial valve leaflet 300 opens during diastole, protect the artificial valve leaflet 300, and avoid the periodic impact between the edge of the artificial valve leaflet 300 and the protruding column peak of the first valve seat body 100 when the artificial valve leaflet 300 opens during diastole, which would cause fatigue of the leaflet material. The frequency of this periodic impact is about 60 times / minute.

[0041] like Figure 6 As shown, the buffer layer 400 is specifically an arc-shaped cap-like structure that matches the top of the protruding pillar peak. The buffer layer 400 covers 120% of the surface area of ​​the protruding part of the protruding pillar peak; specifically, the buffer layer 400 covers the top of the protruding pillar peak and its circumferential edge. The arc-shaped cap-like structure can transform point contact into surface contact, improving the contact stress dispersion efficiency by 40%.

[0042] The buffer layer 400 has a thickness greater at the top than at the edges; that is, the thickness of the buffer layer 400 gradually decreases from the center of the top to the edge, forming a wedge-shaped structure that is thicker at the center and thinner at the edges. This adapts to the dynamic contact angle of 0°-30° when the artificial leaflet 300 opens and closes, avoiding stress concentration at the edges. Specifically, the thickness of the buffer layer 400 at the center of the top is 0.3 mm, and the thickness gradually decreases to 0.1 mm at the edges.

[0043] The buffer layer 400 is an elastic buffer layer 400. The material of the elastic buffer layer 400 can be medical silicone rubber with a Shore A hardness of 30-50 and a thickness of 0.1-0.3mm.

[0044] The surface of the buffer layer 400 that contacts the artificial valve has circumferentially distributed microgrooves 500, the depth of which is 1 / 3 to 1 / 2 of the thickness of the buffer layer 400. For example, the surface of the buffer layer 400 that contacts the first valve seat body 100 has three microgrooves 500. Figure 7 As shown, three micro-grooves 500 are evenly distributed circumferentially along the protruding column peak. The central angle between adjacent micro-grooves 500 is 120°. The groove length is consistent with the coverage area of ​​the buffer layer 400. The three micro-grooves 500 form a ring-shaped track around the top of the protrusion, parallel to the circumferential swing trajectory of the artificial valve leaflet 300 during opening and closing. The cross-section of each micro-groove 500 is semi-circular, with a depth of 0.05 mm, a width of 0.1 mm, and a spacing of 0.5 mm. The micro-grooves 500 can guide blood flow along the surface of the protrusion, reducing the probability of eddy formation and decreasing the eddy intensity by 25%.

[0045] The first valve seat body 100 has an annular groove at the top of its protruding column peak, and the inner wall of the annular groove is provided with circumferentially evenly distributed barbed protrusions. The surface of the buffer layer 400 that contacts the first valve seat body 100 is provided with an annular flange and a recess. The annular groove and the annular flange are correspondingly arranged, that is, the annular groove and the annular flange are interference-fitted, and the interference amount can be 0.02mm. The protrusions and the recesses engage. The buffer layer 400 and the first valve seat body 100 are assembled through the annular groove, protrusions, annular flange and recess, and mechanical locking is achieved through elastic deformation during assembly. For example, the annular groove has a depth of 0.1mm and a width of 0.2mm, and the inner wall of the annular groove is provided with 3 circumferentially evenly distributed barbed protrusions, the protrusions have a height of 0.05mm, and the material of the protrusions is the same as that of the valve seat body.

[0046] By setting a low-hardness elastic buffer layer 400 at the top of the protruding column peak, combined with the stress dispersion design of the micro-groove 500, the local contact stress during the opening and closing of the valve leaflets is reduced by more than 30%. At the same time, the groove structure can guide blood flow and reduce the formation of eddies.

[0047] Limiting devices are provided on the first petal seat body 100 and the second petal seat body 200: The upper portion of the first petal seat body 100 has a raised column peak with a positioning key extending along the axial direction, and the upper portion of the second petal seat body 200 has a corresponding positioning groove. The cross-sectional shapes of the positioning key and the positioning groove are corresponding asymmetrical polygons, such as D-shaped or trapezoidal, and the two are interference-fitted to restrict the circumferential relative rotation of the first petal seat body 100 and the second petal seat body 200.

[0048] The positioning key and the positioning groove have a D-shaped cross-section, with a straight segment length of 3mm and an arc radius of 1.5mm. The straight segment faces the leaflet closing direction, and the arc segment faces away from the leaflet. The positioning groove and the positioning key have complementary shapes, ensuring that the first leaflet body 100 and the second leaflet body 200 can only be embedded in a single direction.

[0049] This avoids misalignment between the leaflet and the raised column peak due to human assembly errors, and solves the problem of easy misalignment during fitting, resulting in uneven stress distribution of the leaflet.

[0050] The inner wall of the second petal seat body 200 is provided with an elastic snap-fit ​​assembly, which includes three arc-shaped spring pieces 600 evenly distributed circumferentially. The free ends of the arc-shaped spring pieces 600 are provided with barbs 700 facing the first petal seat body 100. The outer wall of the first petal seat body 100 is provided with corresponding barb 700 slots. When the first petal seat body 100 and the second petal seat body 200 are nested in place, the barbs 700 are engaged in the barb 700 slots and press the edges of the artificial petal leaf 300 tightly within the gap.

[0051] Specifically, Three or more arc-shaped spring pieces 600 are evenly distributed circumferentially along the inner wall of the second valve seat body 200, corresponding to the gap positions of the three valve leaflets. The included angle between adjacent spring pieces is less than or equal to 120° depending on the number of arc-shaped spring pieces 600, ensuring radial force balance. The thickness of the arc-shaped spring piece 600 is 0.1-0.2 mm, for example, 0.15 mm. The arc-shaped spring piece 600 extends axially, covering the fixed area of ​​the edge of the artificial valve leaflet 300, and has a length of 8 mm. The curvature of the arc-shaped spring piece 600 is consistent with the curvature of the inner wall of the second valve seat body 200. The material of the arc-shaped spring piece 600 can be the same biocompatible rigid material as the valve seat body, such as a TC4 titanium alloy sheet. The root of the arc-shaped spring piece 600 transitions to the inner wall of the second valve seat body 200 through a 0.5 mm wide connecting section to enhance fatigue resistance.

[0052] like Figure 8 As shown, the barb 700 is located at the free end of the arc-shaped spring piece 600 and faces the first petal seat body 100, i.e., radially inward. The height of the barb 700 can be 0.3mm, thus ensuring that it will not fall off after being engaged in the barb 700 slot. The barb 700 has an inclination angle of 45°, facing the direction in which the first petal seat body 100 is axially embedded into the second petal seat body 200, i.e., the first petal seat body 100 is inserted downward from the upper opening end of the second petal seat body 200 until it enters the lower fixing groove, facilitating its sliding over the outer wall of the first petal seat body 100 during assembly. The tip of the barb 700 is a rounded corner with a diameter of 0.05mm to avoid scratching the artificial petal leaf 300. The side of the barb 700 facing away from the nesting direction is a right angle surface, i.e., perpendicular to the nesting direction, realizing a mechanical self-locking mechanism of one-way passage and reverse locking.

[0053] The barb 700 slot is disposed on the outer wall of the first petal seat body 100. Specifically, it is disposed at the transition between the lower and upper portions of the outer wall of the first petal seat body 100, that is, above the step where the outer diameter of the lower portion of the first petal seat body 100 is greater than that of the upper portion. The height of the barb 700 slot corresponds to the axial height of the barb 700 of the second petal seat spring. Specifically, the height of the barb 700 slot is slightly greater than the height of the barb 700, with a reserved assembly tolerance, which can be 0.4mm. The depth of the barb 700 slot matches the height of the barb 700 to ensure complete engagement, which can be 0.3mm. The cross-sectional shape of the barb 700 slot is rectangular, and the bottom of the slot is a rounded corner with a radius of R0.1mm, thereby reducing stress concentration.

[0054] Once the first valve seat body 100 is nested in place, the barb 700 engages with the barb 700 slot, and the free end of the spring clip presses the edge of the artificial valve leaflet 300 into the gap, achieving zero-gap fixation. If the first valve seat body 100 experiences a reverse movement due to blood flow impact or vibration, attempting to dislodge from the second valve seat, the 90° right-angled surface will rigidly contact the sidewall of the barb 700 slot, forming a surface contact lock. Static friction and structural interference prevent relative displacement. The height of the 90° right-angled surface (0.3mm) matches the depth of the barb 700 slot (0.3mm), ensuring zero gap after locking and preventing fretting wear. The tip of the barb 700 is rounded with a radius of 0.05mm to avoid scratching the artificial valve leaflet 300 or surrounding tissue.

[0055] In its natural state, the arc-shaped spring 600 of the elastic buckle assembly is radially inward at a pre-tilt angle of 3° to the inner wall of the second lobe seat body 200. When the outer wall diameter of the first lobe seat is 22.2 mm and the gap is 0.2 mm, the distance between the tip of the barb 700 and the inner wall of the second lobe seat is 22.4 mm, ensuring that there is no interference with the nesting in the initial state.

[0056] When guiding and inserting the first petal seat body 100 and the second petal seat body 200, align the upper portion of the first petal seat body 100 with the upper portion of the second petal seat body, and slowly push them in axially. At this time, the outer wall of the first petal seat body 100 contacts the inclined surface of the barb 700 of the arc-shaped spring piece 600, generating a radially outward thrust. After being pushed, the arc-shaped spring piece 600 undergoes elastic bending, and the barb 700 swings outward with the spring piece, allowing the first petal seat to continue descending. When the lower portion of the first petal seat body 100 is fully inserted into the fixing groove of the second petal seat body 200, the barb 700 slot just reaches the free end position of the arc-shaped spring piece 600. At this time, the elastic potential energy of the arc-shaped spring piece 600 is released, and the barb 700 springs back and engages in the barb 700 slot. During the rebound of the arc-shaped spring 600, its inner surface presses the edge of the artificial petal 300 located in the gap against the outer wall of the first petal seat body 100, achieving a double fixation of tenon and mortise fitting and snap-locking.

[0057] The mechanical self-locking of the valve seat after nesting is achieved by the elastic buckle, which avoids the micro-movement gap problem that may exist in the tenon and mortise fitting, enhances the long-term stability of the artificial leaflet 300 fixation, and eliminates the need for additional stitching or bonding, thus simplifying the assembly process.

[0058] A new type of artificial heart valve with a mortise and tenon structure integrates an artificial valve leaflet between a first valve seat and a second valve seat. The first and second valve seats are combined to form a mortise and tenon structure, and leaflet fixing holes are provided at the connection points between the upper and lower parts of the valve seat. The artificial valve leaflet is fitted together through the mortise and tenon effect, thus realizing the fabrication of the artificial heart valve. This addresses the problems of interference with the leaflet suture section in existing artificial heart valves, which causes errors in the overall symmetry of the artificial valve structure and makes it difficult to replicate the finished product. By fixing the artificial valve leaflet to the bottom of the valve seat, uniform stress on the artificial valve leaflet is ensured, and the medical burden on patients is greatly reduced. It avoids the human influence of manual suturing and impregnation processes, resulting in smaller relative errors, symmetrical leaflets, uniform and reduced stress, with the average stress level decreasing from 0.657 MPa to 0.53 MPa, making the leaflet opening more rounded.

[0059] This type of heart valve reduces the difficulty of attaching the leaflet to the valve seat, improves the effectiveness and efficiency of leaflet attachment, reduces / avoids the impact of sutures on the artificial leaflet portion, enhances the overall symmetry of the artificial valve, helps maintain excellent hemodynamic performance, and thus extends the service life of the heart valve stent. At the same time, it ensures the reproducibility and mass production of the overall structure of the artificial valve.

[0060] 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 mortise and tenon structure prosthetic heart valve, characterized in that, The artificial valve comprises a first valve seat body, a second valve seat body and an artificial valve leaflet.

2. The mortise and tenon structure artificial heart valve according to claim 1, characterized in that, The artificial valve leaflet is composed of three equal and identical valve leaflets and a covering film covering the outer surface of the first valve seat body.

3. The mortise and tenon structure artificial heart valve according to claim 1, characterized in that, The second valve seat body is radially nested with the first valve seat body, and a gap for accommodating the artificial valve leaflet is formed between the inner wall of the second valve seat body and the outer wall of the first valve seat body.

4. The mortise and tenon structure artificial heart valve according to claim 1, characterized in that, The first valve seat body and the second valve seat body each comprise at least two structural segments of an upper segment and a lower segment, the shape and size of the upper segment of the first valve seat body and the upper segment of the second valve seat body are adapted, and the shape and size of the lower segment of the first valve seat body and the lower segment of the second valve seat body are adapted.

5. The mortise and tenon structure artificial heart valve according to claim 4, characterized in that, The upper segment of the first valve seat body is a columnar structure, the shape and size of the cross section of which remain consistent along the axial direction; the lower segment of the first valve seat body is a circular ring base structure; the outer diameter of the lower segment is greater than that of the upper segment.

6. The mortise and tenon structure artificial heart valve according to claim 4, characterized in that, The upper segment of the second valve seat body is a hollow columnar structure, the inner diameter of the cross section of which changes in a predetermined pattern along the axial direction; the lower segment of the second valve seat body is a hollow circular ring structure; the inner diameter of the upper segment of the second valve seat body is adapted to that of the lower segment of the first valve seat body.

7. The mortise and tenon structure artificial heart valve according to claim 4, characterized in that, The lower segments of the first valve seat body and the second valve seat body are both smooth arc structures, and the upper segments of the first valve seat body and the second valve seat body are each provided with three uniformly distributed convex column peaks.

8. The mortise and tenon structure artificial heart valve according to claim 4, characterized in that, The lower segment of the second valve seat body is provided with a fixing groove, the lower segment of the first valve seat body is fixed in the fixing groove, and the edge of the artificial valve leaflet is fixed in the fixing groove and placed between the lower segment of the second valve seat body and the lower segment of the first valve seat body.

9. The mortise and tenon structure artificial heart valve according to claim 8, characterized in that, The upper segments and the lower segments of the first valve seat body and the second valve seat body are each provided with a plurality of valve leaflet fixing holes at one end, the valve leaflet fixing holes are uniformly distributed at the same horizontal position of the upper segments of the first valve seat body and the second valve seat body, and the valve leaflet fixing holes of the first valve seat body correspond to the valve leaflet fixing holes of the second valve seat body, that is, each valve leaflet fixing hole of the first valve seat body corresponds to one valve leaflet fixing hole of the second valve seat body.

10. The mortise and tenon structure artificial heart valve according to claim 1, characterized in that, The first valve seat body and the second valve seat body are made of biocompatible hard material, and the artificial valve leaflet is made of biocompatible flexible material.

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