Heart valve

Abstract

The invention relates to the field of medical instruments, in particular to a heart valve. The invention provides a heart valve. The heart valve comprises a stent body, a skirt edge and developing points. The skirt edge is connected to the bracket body; the skirt edge comprises an inner skirt edge and an outer skirt edge; the inner skirt edge and the outer skirt edge form an interlayer; the developing points are arranged in the interlayer; the number of the developing points is at least two; at least two developing points are in the same or different annular cross sections. Developing points are arranged in an interlayer; the setting mode can physically isolate the developing point, and the direct contact between the bracket and the developing point is eliminated through physical isolation; the galvanic corrosion risk can be effectively avoided, and the service life of instruments is prolonged; the metal ion release risk is reduced, and the biological safety is improved. And the developing points are arranged in the interlayer between the inner skirt edge and the outer skirt edge, so that the overall position of the valve can be reflected more accurately.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular, to a heart valve. Background Art

[0002] Valvular heart disease refers to heart conditions characterized by dysfunction of the heart valves, leading to hemodynamic abnormalities. The human body has four valves: the mitral, tricuspid, aortic, and pulmonary valves. Valvular dysfunction can occur in two ways: stenosis and regurgitation (regurgitation). Stenosis reduces the open area of ​​the valve, obstructing blood flow; regurgitation occurs when the valve fails to fully close, resulting in reverse flow.

[0003] With the development of medical technology, heart valve replacement has become an important means of treating severe heart valve diseases. In this process, accurate positioning of the valve is crucial to the success of the operation. As a positioning mark, the developing point is widely used in the design of heart valves. The developing point is a marking point used to accurately locate the position of the heart valve in imaging examinations. In order to facilitate the doctor to see the position of the installation hole during the operation, the position of the installation hole needs to be marked on the valve stent. The marking method is to set a radiopaque mark on the valve stent. In heart valve replacement surgery, the developing point can help the doctor accurately judge the position and status of the valve, ensuring the accuracy and safety of the operation. Traditional developing points are usually set on the metal stent of the valve stent and are visible through X-rays or other imaging technologies, so as to achieve precise positioning of the valve.

[0004] However, existing heart valves are at risk of electrical contact corrosion. Summary of the Invention

[0005] The purpose of the embodiments of the present application is to provide a heart valve.

[0006] In a first aspect, the present application provides a heart valve, comprising a stent body, a skirt, and a development point; the skirt is connected to the stent body; the skirt comprises an inner skirt and an outer skirt; the inner skirt and the outer skirt form a sandwich; The developing points are arranged in the interlayer; the developing points include at least two.

[0007] In the above technical solution, by setting the developing point in the interlayer; this setting method can physically isolate the developing point, and avoid direct contact between the stent and the developing point through physical isolation; thereby effectively avoiding the risk of galvanic corrosion, extending the life of the device; reducing the risk of metal ion release, and improving biosafety. Moreover, setting the developing point in the interlayer between the inner and outer skirts can more accurately reflect the overall position of the valve. Furthermore, by setting the developing point to include at least two; the developing points of this layout method can form a stable reference system, and the rotational positioning error of intraoperative imaging is small; it can effectively improve the accuracy of the developing positioning and enhance the stability of the developing point, which is beneficial for avoiding the left and right crowns at the valve frame mounting hole during surgery, reducing the risk of coronary artery obstruction, and at the same time, during the secondary valve replacement, the position of the first implanted valve can be identified. Therefore, it is beneficial to improve the accuracy and operational efficiency of interventional surgery.

[0008] In other embodiments of the present application, the above-mentioned developing points include three; the three developing points are respectively a first developing point, a second developing point and a third developing point; the first developing point, the second developing point and the third developing point are symmetrically arranged.

[0009] In other embodiments of the present application, the shape of the development point includes: any one of: O-shape, C-shape or T-shape.

[0010] In other embodiments of the present application, the material of the developing point includes: any one of gold, tantalum or platinum-iridium alloy.

[0011] In other embodiments of the present application, the inner skirt and the outer skirt are both made of polymer film material.

[0012] In other embodiments of the present application, at least two of the development points are in the same or different annular cross-sections.

[0013] In other embodiments of the present application, the stent body includes a mounting hole; the mounting hole is used to connect and fix the leaflet to the stent body; The axis of at least one of the mounting holes passes through at least one of the developing points.

[0014] In other embodiments of the present application, the support body includes a middle section and a bottom; at least one of the imaging points is located at the bottom of the support body; or At least one of the developing points is located in the middle section of the bracket body.

[0015] In other embodiments of the present application, the material of the inner skirt and the outer skirt includes: any one of polyethylene terephthalate, polytetrafluoroethylene or polyurethane.

[0016] In other embodiments of the present application, the bracket body includes a top; and the vertical distances from at least two developing points to the top of the bracket body are the same.

[0017] In other embodiments of the present application, the inner skirt is connected to the inner peripheral wall of the bracket body, and the outer skirt is connected to the outer peripheral wall of the bracket body.

[0018] In other embodiments of the present application, the thickness of the inner skirt and the outer skirt are the same.

[0019] In other embodiments of the present application, the thickness of the inner skirt and the outer skirt are both 0.02 mm to 0.1 mm.

[0020] In other embodiments of the present application, the developing point has a threading hole; the developing point is sewn and connected to the inner skirt and the outer skirt; or The developing point is connected with the inner skirt edge and the outer skirt edge by adopting a hot pressing method. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0022] Figure 1 A structural diagram of a heart valve from a first perspective in the first specific embodiment provided in this application; Figure 2 A structural diagram of a heart valve from a second perspective in the first specific embodiment provided in this application; Figure 3 A schematic structural diagram of a heart valve stent body in the first specific embodiment provided in this application; Figure 4 A top view of a heart valve according to a first embodiment of the present application; Figure 5 A schematic diagram of connecting the imaging point with the inner and outer skirts in a heart valve provided in an embodiment of the present application; Figure 6 A schematic diagram of a partial structure of a heart valve in the second specific embodiment provided in this application; Figure 7 A partial structural diagram of a heart valve according to a third embodiment of the present invention is provided; Figure 8 This is a schematic diagram of the partial structure of the heart valve in the fourth specific embodiment provided in this application.

[0023] Icons: 100-heart valve; 110-stent body; 111-top; 112-bottom; 113-middle section; 120-skirt; 121-inner skirt; 122-outer skirt; 130-development point; 140-mounting hole. DETAILED DESCRIPTION

[0024] In order to make the purpose, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments.

[0025] Therefore, the following detailed description of the embodiments of the present application is not intended to limit the scope of the present application for protection, but merely represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0026] Research has found that the imaging points of existing heart valves are typically located on the metal stent body. Because the stent body and the imaging points are typically made of different metals, and because different metals have a potential difference in the blood electrolyte environment (for example, the potential difference between nickel-titanium alloy and platinum is approximately 0.5V), the imaging points and the metal stent body can form a micro-battery effect, leading to heart valve corrosion.

[0027] Further research found that traditional imaging points are distributed on the stent body, which can easily lead to imaging positioning deviations due to the asynchronous movement of the stent body and the valve.

[0028] Based on the above research, Figure 1-Figure 7 An embodiment of the present application provides a heart valve 100, which includes a stent body 110, a skirt 120 and a developing point 130; the skirt 120 is connected to the stent body 110; the skirt 120 includes an inner skirt 121 and an outer skirt 122; the inner skirt 121 and the outer skirt 122 form a sandwich; the stent body 110 includes a mounting hole 140, which is used to connect and fix the leaflet to the stent body 110.

[0029] The developing points 130 are provided in the interlayer; the developing points 130 include at least two.

[0030] In the above technical solution, the developing point is set in the interlayer, wherein the developing point 130 is connected to the inner and outer skirts in the manner as follows: Figure 5As shown in the figure, this setup physically isolates the imaging point, preventing direct contact between the stent and the imaging point. This effectively avoids the risk of galvanic corrosion, prolongs device life, reduces the risk of metal ion release, and improves biosafety. Furthermore, placing the imaging point in the interlayer between the inner and outer skirts more accurately reflects the overall position of the valve.

[0031] Furthermore, the imaging points 130 include at least two. This arrangement of imaging points can form a stable reference system, minimizing rotational positioning errors during intraoperative imaging. This effectively improves imaging positioning accuracy, enhances imaging point stability, and reduces the risk of dislodgment. This helps enhance the precision and efficiency of interventional procedures.

[0032] Furthermore, in some embodiments of the present application, the inner skirt 121 is connected to the inner peripheral wall of the bracket body 110 ; and the outer skirt 122 is connected to the outer peripheral wall of the bracket body 110 .

[0033] Furthermore, in some embodiments of the present application, the above-mentioned developing point 130 is embedded in the interlayer formed by the inner skirt and the outer skirt, and the distance from the outer wall surface of the bracket body 110 is ≥1mm; thereby being more conducive to reducing the risk of corrosion.

[0034] Furthermore, in some embodiments of the present application, the above-mentioned bracket body is not the invention point of the present application, and the above-mentioned bracket body can adopt the bracket body structure commonly used in the field.

[0035] For example, in some embodiments of the present application, the above-mentioned stent body can adopt the stent body (including the outer stent and the inner stent) in Chinese patent CN120304996 A; the position and connection relationship between the skirt and the stent body is not the improvement point of the present application; the position and connection relationship in CN 109106470 A can be adopted; or other common stent body and skirt position results in the field. For example, in some embodiments of the present application, the above-mentioned stent body can adopt the structure as described in the specification. Figure 3 The valve stent is shown.

[0036] Further optionally, in some embodiments of the present application, the skirt can be connected to the bracket body by suturing. For example, in some embodiments of the present application, the position of the skirt can be as shown in the specification. Figure 1 and Figure 2 provided at the bottom 112 of the bracket body 110, the height of the bracket body 110 is approximately two-thirds of the height.

[0037] The heart valve of this application, "the bottom and top of the stent body" are the positional relationships during routine use by those skilled in the art in the application scenario (heart valve replacement surgery), such as Figure 2 The positional relationship between the bottom 112 and the top 111 of the bracket body 110 is shown.

[0038] Reference Figure 2 The bracket body 110 includes, from bottom to top, a bottom 112, a middle section 113, and a top 111; the bottom 112 is the inflow end, and the top 111 is the outflow end.

[0039] Furthermore, in some embodiments of the present application, at least two of the development points 130 are located in the same or different annular cross-sections.

[0040] Furthermore, in some embodiments of the present application, the axis of at least one mounting hole 140 passes through at least one developing point 130 .

[0041] For example, referring to Figure 1 , a developing point 130 is located directly below the mounting hole 140 , and at this time, the axis of the mounting hole 140 passes through the developing point 130 .

[0042] Furthermore, in some embodiments of the present application, one or more developing points 130 are located at or not located at the bottom 112 of the support body 110. For example, referring to Figure 2 and Figure 7 , the developing point 130 may be located at the bottom 112 of the bracket body 110 ; or the developing point 130 may be located at the middle section 113 of the bracket body 110 .

[0043] Further optionally, in some embodiments of the present application, as Figure 4 As shown, the three developing points are in the same annular cross section. In other optional embodiments, two developing points can be set in the same annular cross section; in other optional embodiments, more than three developing points can be set in the same annular cross section.

[0044] Furthermore, in some embodiments of the present application, Figure 4 As shown, there are three developing points 130 ; the three developing points 130 are respectively a first developing point, a second developing point and a third developing point; the first developing point, the second developing point and the third developing point are symmetrically arranged, and the three developing points are in the same annular cross-section.

[0045] In the above technical solution, the first imaging point, the second imaging point and the third imaging point are symmetrically arranged on the skirt interlayer; a collaborative positioning function is achieved, so that the three imaging points can form a stable reference system under X-ray imaging, providing accurate position identification for the artificial heart valve when implanted in the body (combined with Figure 4 , Figure 4This stable reference system minimizes rotational positioning errors during intraoperative imaging, improving the accuracy and efficiency of interventional procedures.

[0046] Furthermore, the three developing points are respectively located directly below the three mounting holes 140 , which can be used to indicate the position of the mounting holes and also to prompt the developing points to align with the position of the native valve ring when the valve is released, thereby improving the accuracy of the axial release of the valve.

[0047] Furthermore, through the layout of the development points and the connection structure, it is ensured that the actual position of the valve can be clearly and accurately determined under X-ray fluoroscopy, and the physical isolation design avoids galvanic corrosion, thereby extending the service life of the device; at the same time, it reduces the risk of metal ion release, improves biosafety, and meets the strict requirements of medical device biocompatibility and long-term implantation.

[0048] In some embodiments of the present application, the developing points are sewn to the sandwich area of ​​the inner and outer skirts, and the three developing points are symmetrically arranged to form a stable reference system, ensuring that clear and balanced positioning marks can be provided under X-rays.

[0049] Further optionally, in some embodiments of the present application, as Figure 6 As shown, the developing points 130 include two; the two developing points 130 are respectively the first developing point and the second developing point; the first developing point and the second developing point are sewn to the interlayer area of ​​the inner and outer skirts, the first developing point and the second developing point are in different annular cross-sections, the first developing point and the second developing point are respectively directly below different mounting holes 140, and are located at the bottom 112 of the bracket body 110.

[0050] Further optionally, in some embodiments of the present application, as Figure 7 As shown, there are three developing points 130, which are the first developing point, the second developing point, and the third developing point; the first developing point, the second developing point, and the third developing point are sewn to the interlayer area of ​​the inner and outer skirts, and the three developing points are arranged asymmetrically, and the three developing points are in different annular cross-sections; among them, two developing points are respectively directly below the two mounting holes 140 and in the middle section 113 of the bracket body 110; one developing point is between the two mounting holes 140 and at the bottom 112 of the bracket body 110.

[0051] Further optionally, in some embodiments of the present application, as Figure 8As shown, there are two developing points 130; the two developing points 130 are respectively the first developing point and the second developing point, the first developing point and the second developing point are sewn to the interlayer area of ​​the inner and outer skirts, the first developing point and the second developing point are in different annular cross-sections, and are not directly below the mounting hole 140, one developing point 130 is at the bottom 112 of the bracket body 110; the other developing point 130 is at the middle section 113 of the bracket body 110.

[0052] above Figure 6-Figure 8 The several embodiments shown can also realize the collaborative positioning function, providing precise position identification for the artificial heart valve when implanted in the body; among them, the developing point 130 directly below the mounting hole 140 can be used to indicate the position of the mounting hole 140, so that the mounting hole 140 avoids the coronary artery opening; the developing point 130 at the bottom 112 of the stent body 110 can be used to indicate the bottom position of the leaflet, so that the coronary artery opening is aligned with the middle position of the leaflet.

[0053] In other optional implementations, one or more developing points 130 may be selected not to be located directly below the mounting hole 140 .

[0054] In other optional embodiments, one or more developing points 130 may be selected not to be located at the bottom 112 of the bracket body 110 .

[0055] In other optional implementations, more than three developing points 130 may be selected to be in different annular cross sections.

[0056] Furthermore, in some embodiments of the present application, the shape of the development point 130 includes any one of: O-shape, C-shape or T-shape.

[0057] For example, in some embodiments of the present application, the shape of the above-mentioned developing point can be selected as a ring (for example, the shape of "0"; or the shape of "O"); in some embodiments of the present application, the shape of the above-mentioned developing point can be set to a semi-ring (for example, the shape of "C", etc.) or; in some embodiments of the present application, the shape of the above-mentioned developing point can be set to a T-shape.

[0058] In the above technical solution, by setting the shape of the developing point to include: any one of: ring shape, C shape or T shape, it can also be set to other shapes; it is convenient to connect the developing point to the interlayer formed by the inner skirt and the outer skirt.

[0059] Furthermore, in some embodiments of the present application, the material of the developing point 130 includes: any one of gold, tantalum, or platinum-iridium alloy.

[0060] For example, in some embodiments of the present application, the material of the development point can be selected as gold; or in some embodiments of the present application, the material of the above-mentioned development point can be selected as tantalum; or in some embodiments of the present application, the material of the above-mentioned development point can be selected as platinum-iridium alloy.

[0061] Furthermore, in some embodiments of the present application, the inner skirt 121 and the outer skirt 122 are both made of polymer film materials.

[0062] In the above technical solution, the material of the developing point includes gold, tantalum, or platinum-iridium alloy; the inner and outer skirts are made of polymer film. The potential difference ΔE between the developing point material and the skirt is less than 0.1V, further reducing the risk of microbatteries. This achieves dual corrosion protection through physical isolation and material matching, thereby eliminating microbattery corrosion.

[0063] Furthermore, in some embodiments of the present application, the skirt is made of a polymer film material, the skirt can be formed by leaching and coating processes, and the developing ring can be embedded in the material.

[0064] Furthermore, in some embodiments of the present application, the material of the inner skirt and the outer skirt includes: any one of polyethylene terephthalate, polytetrafluoroethylene or polyurethane.

[0065] Furthermore, in some embodiments of the present application, vertical distances from at least two developing points 130 to the top 111 of the bracket body 110 are the same.

[0066] In the above technical solution, the distances from the developing points to the top 111 of the bracket body 110 are set to be equal or different, so that the developing points are located in the same or different annular cross sections.

[0067] Furthermore, in some embodiments of the present application, the distances between at least two developing points 130 and the top 111 of the bracket body 110 are both 5 mm to 5.5 mm.

[0068] For example, in some embodiments of the present application, the distances from the at least two developing points to the top 111 of the bracket body 110 are 5 mm, 5.1 mm, 5.2 mm, 5.3 mm, 5.4 mm, 5.5 mm or a range between any two of the aforementioned values.

[0069] Furthermore, in some embodiments of the present application, the thickness of the inner skirt and the outer skirt are the same.

[0070] Furthermore, in some embodiments of the present application, the thickness of the inner skirt and the outer skirt are both 0.02 mm to 0.1 mm.

[0071] For example, in some embodiments of the present application, the thickness of the inner skirt and the outer skirt are both 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.1 mm or a range between any two of the foregoing values.

[0072] In the above technical solution, by setting the inner skirt and the outer skirt to have the same thickness, it is beneficial to accurate positioning.

[0073] Furthermore, in some embodiments of the present application, the developing point has a threading hole; the developing point is sewn and connected to the inner skirt and the outer skirt.

[0074] In the above technical solution, by sewing the developing point to the inner skirt and the outer skirt, the stability of the connection between the developing point and the inner skirt and the outer skirt can be further improved, thereby avoiding the risk of the developing point falling off.

[0075] Furthermore, in some embodiments of the present application, the developing point is arranged in the interlayer of the inner skirt and the outer skirt. By pre-setting a threading hole at the developing point, accurately aligning it with the pre-punched holes of the inner and outer skirts, threading the suture, winding it in a ring, and fixing it with a knot, and sealing the knot, a special fixed structure with a stable connection is formed, which can effectively enhance the stability of the developing point and reduce the risk of falling off.

[0076] In some embodiments of the present application, the number of threading holes provided at the above-mentioned developing point is selected to be at least two. By providing at least two threading holes, the developing point can be more conveniently sewn and connected to the interlayer formed by the inner skirt and the outer skirt.

[0077] For example, in some embodiments of the present application, the developing point is sewn together with the inner skirt and the outer skirt, and the connection can be performed in the following manner: The developing point is firmly connected to the inner and outer skirts through stitching. The specific connection details are as follows: Transparent positioning marking areas are pre-set at the corresponding development points on the inner and outer skirts, and precision equipment is used to ensure minimal positioning error. Threading holes are marked at the center and development points on the inner and outer skirts.

[0078] Medical-grade polypropylene monofilament sutures are selected, and the "sandwich suture method" is adopted. The suture is first inserted into the pre-punched hole from the outside of the inner skirt, enters the interlayer in a clockwise direction, and passes through the first threading hole of the developing point, so that the developing point is tightly fitted to the inside of the inner skirt. Subsequently, the suture is wrapped around the outside of the developing point, and passes through the corresponding hole of the outer skirt, the next threading hole of the developing point, and the corresponding hole of the inner skirt in turn, forming a cross-winding path of "inner skirt → developing point → outer skirt → developing point → inner skirt". Finally, a double-line surgical square knot is tied at the developing point and the inside of the skirt. Through the above connection method, the developing point is firmly locked between the inner and outer skirt interlayers, which not only ensures the stability of the valve when it is working, but also eliminates the risk of galvanic corrosion caused by direct contact between the stent and the developing point due to physical isolation, thereby improving the biosafety and service life of the device.

[0079] The imaging sites should be made of metal materials with excellent biocompatibility, high X-ray absorption coefficient, and inherent corrosion resistance, preferably precious metals and their alloys, such as platinum (Pt) and its alloys, gold (Au), and tantalum (Ta). Easily corroded or potentially active metals, such as stainless steel, nickel-titanium alloys, and cobalt-chromium alloys, should be avoided as imaging site materials to avoid significant potential differences with the main stent metal or the body fluid environment.

[0080] In some embodiments of the present application, the developing point is connected to the inner skirt and the outer skirt by heat pressing.

[0081] For example, in some embodiments of the present application, each developing point can be completely embedded in a dense isolation layer formed by a biocompatible polymer material, such as polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), silicone rubber, polyurethane, polyetheretherketone (PEEK), or a biological tissue layer. The polymer layer tightly wraps the developing point and acts as an insulating barrier. The developing point is precisely positioned and firmly fixed in the interlayer space between the inner and outer polymer coverings or tissue layers of the valve stent. The interlayer structure itself constitutes a physically isolated chamber in which the developing point is in contact only with the polymer material that covers it, and is not in direct contact with the metal frame of the stent, nor is it exposed to flowing blood or tissue fluid.

[0082] The present invention eliminates any metal-to-metal contact between the precious metal at the development point and the stent's main metal, completely eliminating the necessary pathways for the formation of macroscopic or microscopic galvanic corrosion cells. The dense polymer barrier effectively blocks the penetration and free migration of electrolytes in body fluids, disrupting the ion pathways necessary for the formation of corrosion cells. The selected precious metals (platinum, gold, and tantalum) are thermodynamically stable in physiological environments, possess extremely high redox potentials, and are inherently extremely resistant to corrosion. Their passivation properties further enhance corrosion resistance.

[0083] Furthermore, the development points of the present application are designed to be small and regular geometric shapes, which can minimize the impact on the fluid dynamics performance and structural integrity of the valve and reduce potential stress concentration points.

[0084] Furthermore, the present invention provides a stable fixation method for the development points: the development points are securely fixed in the sandwich structure by means of polymer coating and interlocking, hot pressing, or seaming during the polymer layer manufacturing process, thereby preventing displacement. The use of adhesives or mechanical connectors that may introduce other metals or potential corrosion risks is avoided.

[0085] Furthermore, the imaging materials (Pt, Au, Ta) and isolation polymer materials selected in this application are all materials that are widely used in long-term implantable medical devices and have been proven to have excellent biocompatibility.

[0086] In summary, the heart valve provided by the embodiments of this application can effectively suppress the microbattery effect, reduce the risk of stent corrosion, and significantly improve the long-term safety and reliability of the device. Furthermore, the unique suture method can improve the stability of the imaging point and facilitate intraoperative imaging observation.

[0087] The above description is merely a preferred embodiment of the present application and is not intended to limit the present application. Various modifications and variations are possible for those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present application shall be included within the scope of protection of the present application.

Claims

1. A heart valve, characterized in that: The heart valve comprises a stent body, a skirt and a development point; the skirt is connected to the stent body; the skirt comprises an inner skirt and an outer skirt; the inner skirt and the outer skirt form a sandwich; The developing points are arranged in the interlayer; the developing points include at least two.

2. The heart valve according to claim 1, wherein The developing points include three; the three developing points are respectively a first developing point, a second developing point and a third developing point; the first developing point, the second developing point and the third developing point are symmetrically arranged.

3. The heart valve according to claim 1, wherein The shape of the developing point includes any one of: O-shape, C-shape or T-shape.

4. The heart valve according to claim 1, wherein At least two of the development points are located in the same or different annular cross sections.

5. The heart valve according to claim 1, wherein The stent body includes a mounting hole; the mounting hole is used to connect and fix the leaflet to the stent body; The axis of at least one of the mounting holes passes through at least one of the developing points.

6. The heart valve according to claim 1, wherein The support body includes a middle section and a bottom section; At least one of the developing points is located at the bottom of the support body; or At least one of the developing points is located in the middle section of the bracket body.

7. The heart valve according to claim 1, wherein The support body includes a top portion; The vertical distances between at least two of the developing points and the top of the support body are the same.

8. The heart valve according to claim 1, wherein The inner skirt and the outer skirt have the same thickness.

9. The heart valve according to claim 8, characterized in that The thickness of the inner skirt and the outer skirt are both 0.02 mm to 0.1 mm.

10. The heart valve according to any one of claims 1 to 9, characterized in that: The developing point has a threading hole; the developing point is connected to the inner skirt and the outer skirt by sewing; or the developing point is connected to the inner skirt and the outer skirt by using a hot pressing method.

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