An atrioventricular valve prosthesis device

Abstract

The application relates to a kind of atrioventricular valve prosthesis devices, comprising outer frame, inner frame fixedly arranged in the outer frame and prosthesis valve assembly fixedly arranged in the inner frame;Wherein, the outer frame includes central part and atrial part and ventricular part formed in the axial both ends of the central part respectively;The atrial part includes a plurality of atrial anchors arranged along the circumference of the central part and radially outwardly unfolded;The ventricular part includes a plurality of ventricular anchors distributed along the circumference of the central part and discontinuously arranged, the plurality of ventricular anchors are unfolded radially outwardly relative to the central part, and the number of units of the atrial anchor is more than the number of units of the ventricular anchor.The application effectively reduces the risk of paravalvular leakage, anchoring instability and outflow obstruction after the implantation of atrioventricular valve prosthesis device, effectively improves the stability after the implantation of atrioventricular valve prosthesis device, and is not prone to the displacement of atrioventricular valve prosthesis device.

Description

Technical Field

[0001] This invention specifically relates to an atrioventricular valve prosthesis device. Background Technology

[0002] This section is intended to provide background or context for embodiments of the present invention. The description herein is not intended to imply that it is prior art simply because it is included in this section.

[0003] Mitral valve dysfunction involves various pathological conditions, including valvular insufficiency (regurgitation), leaflet prolapse, and orifice stenosis. Mitral regurgitation occurs when insufficient leaflet closure occurs under systolic ventricular hypertension, causing blood to flow backward from the left ventricle into the left atrium. Anatomical factors leading to impaired leaflet closure can be attributed to leaflet tissue damage, geometric dilation of the valve annulus, chordae tendineae rupture, and insufficient blood supply to the papillary muscles. Leaflet prolapse or bulging towards the left atrium can also cause regurgitation. Furthermore, the reduced orifice area caused by mitral stenosis hinders the proper filling of the ventricle with atrial blood during diastole, similarly impairing normal valve function.

[0004] Current intervention strategies for mitral regurgitation are mainly divided into pharmacological control and surgical correction, the latter aiming to reduce the regurgitant flow. Traditional repair procedures include improving occlusion by annular expansion of the valve annulus, such as implanting a ring structure around the valve to tighten the annulus; or using leaflet suturing, clamping, and other methods to promote leaflet apposition. A more thorough approach is to remove the native valve and replace it with a mechanical or biological prosthesis. These procedures mostly rely on open-chest cardiopulmonary bypass, resulting in significant trauma, and the postoperative pain, mortality risk, and recovery period are all considerable. Furthermore, insufficient durability and improper size selection of repair or replacement devices often lead to complications, and many repair procedures require a high level of surgeon experience; misalignment of the clamping device will directly affect the treatment outcome.

[0005] In recent years, transcatheter aortic valve replacement (TAVR) has made significant progress. The prosthesis typically includes an expandable stent and a tricuspid valve structure. The stent is designed to fit snugly against the relatively rigid, round aortic root, achieving stable anchorage thanks to the root's anatomical features and minimizing displacement. However, the mitral valve's anatomy is far more complex than the aorta, presenting unique challenges for replacement surgery. First, the mitral annulus is asymmetrical, D-shaped, saddle-shaped, and undergoes significant deformation during the cardiac cycle, lacking a fixed shape. This makes it difficult to maintain uniform contact between the prosthesis and the annulus; gaps can easily lead to paravalvular leakage, and over-expanded stents may induce residual shunts. Second, the symmetrical, round support structure upon which current aortic valve prostheses rely cannot adapt to the dynamic, irregular loads on the mitral annulus. If the support structure deforms due to compression from the annulus or surrounding tissues, it will affect the opening and closing durability of the tricuspid valve. Furthermore, the annular size of patients with mitral regurgitation is often much larger than that of the aortic valve. As the valve diameter increases, the blood flow stress on the leaflets rises sharply, necessitating a leaflet configuration specifically designed for mitral valve hemodynamics. Thirdly, the mitral valve annulus lacks the fibro-elastic tissue surrounding it found in the aortic root, which provides effective anchoring force for the prosthesis. The mitral valve is surrounded only by myocardial tissue, whose strong radial contractile force easily destabilizes the implant structure. Fourthly, the left ventricle contains a network of chordae tendineae, a structure absent in the aortic valve region. Its intervention can interfere with the positioning and release via the transcatheter approach, especially when operating from the ventricular side, where the chordae tendineae often increase the difficulty of instrument passage.

[0006] The aforementioned anatomical obstruction also exists in the right tricuspid valve. Although it normally has a tricuspid structure, the treatment difficulty is similar to that of the mitral valve, and therefore, it is also necessary to develop a high-performance valve prosthesis.

[0007] In summary, current interventional treatment of heart valves still faces many bottlenecks, and there is an urgent need to develop devices and methods that are structurally simpler, easier to operate, less invasive, and safer. Summary of the Invention

[0008] The purpose of this invention is to provide an improved atrioventricular valve prosthesis device.

[0009] To achieve the above objectives, the technical solution adopted by the present invention is as follows: This invention provides an atrioventricular valve prosthesis device, comprising an outer frame, an inner frame fixedly disposed within the outer frame, and a prosthesis valve assembly fixedly disposed within the inner frame; wherein, the outer frame includes a central portion and an atrial portion and a ventricular portion respectively formed at both axial ends of the central portion; the atrial portion includes a plurality of atrial anchors arranged circumferentially along the central portion and extending radially outward; the ventricular portion includes a plurality of ventricular anchors distributed circumferentially along the central portion and discontinuously arranged, the plurality of ventricular anchors extending radially outward relative to the central portion, and the number of units of the atrial anchors is greater than the number of units of the ventricular anchors.

[0010] In some embodiments, the ventricular portion further includes at least one extension extending axially along the central portion. When there are multiple extensions, the multiple extensions are spaced apart circumferentially along the central portion, and the circumferential length of all the extensions accounts for 1 / 6 to 5 / 6 of the total circumference of the central portion, for example, 1 / 6, 1 / 3, 1 / 2, 2 / 3 or 5 / 6.

[0011] Furthermore, the total axial length of the central portion and the extension is 5-20 mm, for example, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm or 20 mm.

[0012] Furthermore, the circumferential length of all the extended segments accounts for 5 / 12 to 5 / 6 of the total circumference of the central portion, for example, 5 / 12, 1 / 2, 7 / 12, 2 / 3, 3 / 4 or 5 / 6.

[0013] Furthermore, the circumferential length of one of the extended segments accounts for 1 / 6 to 2 / 3 of the total circumference of the central portion, for example, 1 / 6, 1 / 3, 1 / 2 or 2 / 3.

[0014] Furthermore, the total axial length of the central portion and the extension is 10-16 mm, for example, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm or 16 mm.

[0015] In some embodiments, the ventricular portion further includes at least one inwardly curved segment that is radially concave from the central portion. When there are multiple inwardly curved segments, the multiple inwardly curved segments are spaced apart circumferentially along the central portion, and the circumferential length of all the inwardly curved segments accounts for 1 / 6 to 2 / 3 of the total circumference of the central portion, for example, 1 / 6, 1 / 3, 1 / 2 or 2 / 3.

[0016] Furthermore, the total axial length of the central portion and the inner curved section is 3-18 mm, for example, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm or 18 mm.

[0017] Furthermore, the circumferential length of all the said inner curved segments accounts for 1 / 4 to 2 / 3 of the total circumference of the central portion, for example, 1 / 4, 1 / 3, 5 / 12, 1 / 2, 7 / 12 or 2 / 3.

[0018] Furthermore, the total axial length of the central portion and the inner curved section is 5-18 mm, for example, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm or 18 mm.

[0019] Furthermore, the ventricular end of the inner frame is fixedly connected to the inner curved section, and the central portion of the inner frame and the atrium portion of the outer frame are spaced apart.

[0020] Furthermore, the connection point where the inner frame is fixedly connected to the outer frame is radially aligned with the tip of the inner curved section.

[0021] Furthermore, the distance from the outer surface of the inner frame to the inner surface of the central portion is 1-15mm, for example, 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm or 15mm.

[0022] In some embodiments, the ventricular portion further includes an extension extending axially along the central portion and an inwardly curved section radially concave from the central portion, the ventricular anchor, the extension, and the inwardly curved section together forming a closed-loop structure.

[0023] In some embodiments, the atrial end of the inner frame and the atrial end of the outer frame are fixedly connected by a connector.

[0024] Furthermore, the connector is formed at the atrial end of the central portion and is radially concave inward, or the connector is formed at the atrial end of the inner frame and is radially outward.

[0025] In some embodiments, the ventricular end of the inner frame and the ventricular end of the outer frame are fixedly connected by a connector.

[0026] Furthermore, the connector is formed at the ventricular end of the inner frame and extends radially outward, or the connector is formed at the ventricular end of the central portion and is recessed radially inward.

[0027] In some embodiments, the inner frame includes a cylindrical main body segment and an everted segment extending radially outward from the atrial or ventricular end of the main body segment, the everted segment being located in part or all of the circumferential arc segment of the main body segment.

[0028] In some embodiments, the angle between the atrial anchor and the axis of the atrioventricular valve prosthesis device is 45-80°, for example 45°, 50°, 55°, 60°, 65°, 70°, 75° or 80°.

[0029] In some embodiments, the angle between the ventricular anchor and the axis of the atrioventricular valve prosthesis device is 45-80°, for example 45°, 50°, 55°, 60°, 65°, 70°, 75° or 80°.

[0030] In some embodiments, the deployment angle of the ventricular anchor is greater than that of the atrial anchor.

[0031] In some embodiments, the maximum cross-sectional area of ​​the atrial portion is greater than the maximum cross-sectional area of ​​the ventricular portion.

[0032] Furthermore, the maximum cross-sectional area of ​​the atrium is 3-20% larger than the maximum cross-sectional area of ​​the ventricle, for example, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, or 20%.

[0033] In some embodiments, the tip of the atrial anchor points towards the atrium.

[0034] In some embodiments, the tip of the ventricular anchor points toward the ventricle.

[0035] In some embodiments, the atrial portion includes a plurality of atrial units forming peaks and troughs in the circumferential direction, the ventricular portion includes a plurality of ventricular units forming peaks and troughs in the circumferential direction, the number of atrial units is divisible by 3, the number of ventricular units is divisible by 2 and / or 3, and the number of ventricular units is greater than the number of atrial units.

[0036] In some embodiments, the atrioventricular valve prosthesis device further includes a plurality of fixation hooks fixedly disposed on the outer wall of the ventricular anchor and / or the central portion, each of the fixation hooks extending radially outward and pointing toward the atrium.

[0037] Furthermore, the ratio of the radius of curvature to the thickness of each of the fixed hooks is between 4:1 and 6:1.

[0038] Furthermore, the thickness of each of the fixing hooks is between 0.2 mm and 1 mm.

[0039] Furthermore, the angle between each of the fixing hooks and the axis of the atrioventricular valve prosthesis device is 50-80°.

[0040] In some embodiments, the atrioventricular valve prosthesis device further includes a sealing skirt disposed on the inner and / or outer wall surfaces of the inner frame, and on the inner and / or outer wall surfaces of the portion of the outer frame excluding the ventricular anchor.

[0041] In some embodiments, the atrioventricular valve prosthesis device further includes a radiopaque body disposed at the atrial anchor, the radiopaque body being spring-shaped, woven, and / or composed of multiple interconnected small balls.

[0042] In some embodiments, the atrioventricular valve prosthesis device further includes a leaflet clamp for holding the native leaflet.

[0043] Furthermore, the leaflet clip includes a clip body that is curved in an arc and has a first end and a second end opposite to each other. The clip body has a hollow frame structure. The first end of the clip body has a mounting part for fixed connection with the ventricular portion or the central portion. The second end of the clip body points towards the atrium. Furthermore, a through hole is formed on the second end of the clip body for a wire to pass through so as to pull the clip body towards the ventricle.

[0044] Furthermore, the leaflet clip includes a mounting part for fixed connection with the ventricular portion or the central portion, and a clip body that is elongated and has multiple hollow structures distributed along the axial direction. The first end of the clip body is curved and fixedly connected to the ventricular end of the mounting part or integrally formed therein. The second end of the clip body opposite to the first end points towards the atrium and allows a suture to pass through so that the clip body can be pulled towards the ventricle.

[0045] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art: This invention simplifies the structure of the atrioventricular valve prosthesis device through the structural design of the inner and outer frames, especially the circumferential irregular structure of the ventricular end of the outer frame. It also effectively reduces the risk of paravalvular leakage, anchoring instability, and outflow tract obstruction after implantation of the atrioventricular valve prosthesis device, effectively improving the stability of the atrioventricular valve prosthesis device after implantation and making it less prone to displacement. Attached Figure Description

[0046] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0047] Figure 1 A schematic diagram showing the implantation of an atrioventricular valve prosthesis into the mitral valve. Figure 2 A schematic diagram showing the implantation of an atrioventricular valve prosthesis device into a tricuspid valve; Figure 3 A perspective view of an atrioventricular valve prosthesis device with leaflet clips, fixing hooks set in the ventricular anchor, and having an extension and an inward curve; Figure 4 A front view of an atrioventricular valve prosthesis device with leaflet clips, fixing hooks set in the ventricular anchor, and having an extension and an inward curve; Figure 5 A three-dimensional view of an atrioventricular valve prosthesis device with leaflet clips, fixing hooks set in the ventricular anchor, and having an inwardly curved section but no extension section; Figure 6 A perspective view of an atrioventricular valve prosthesis device that is leafletless, with a fixing hook located in the central part and having an extension and an inward curve. Figure 7 A three-dimensional view of the outer and inner frames of the ventricular anchor with leaflet clips and fixing hooks, and having an extension and an inward curve. Figure 8 A top view of the outer and inner frames of the ventricular anchor with leaflet clips and fixing hooks, and having an extension and an inward curve. Figure 9 A top view of the outer frame with leaflet clips, fixing hooks, and an extension and inward curve section, mounted on the ventricular anchor. Figure 10 A three-dimensional view of an outer frame with leaflet clips, fixing hooks, and an extension and inward curve section, mounted on a ventricular anchor. Figure 11 This is a schematic diagram of the outer frame unfolding along the axial direction. Figure 12 A three-dimensional view of the outer frame after heat treatment; Figure 13 A three-dimensional view of an outer frame with an extension and an inward bend, in which a fixing hook is installed on a ventricular anchor. Figure 14 A three-dimensional view of the inner frame and prosthetic valve assembly; Figure 15 A three-dimensional view of an outer frame with a fixed hook set in a ventricular anchor and having an inwardly curved section but no extension section; Figure 16 A perspective view of an outer frame with leaflet clips and fixing hooks set in the ventricular anchor and having an extension and an inward curve, and an inner frame of another configuration; Figure 17 A three-dimensional view of an internal frame configuration; Figure 18 A schematic diagram of an internal frame configuration unfolded axially; Figure 19 A three-dimensional view of an inner frame with another configuration; Figure 20 A three-dimensional view of an inner frame with an outwardly flared section; Figure 21 A three-dimensional view of an inner frame with an outward-flaring section; Figure 22This is a 3D view of the inner and outer frames; Figure 23 This is a 3D view of the inner and outer frames; Figure 24 A perspective view of an atrioventricular valve prosthesis device with leaflet clips, fixing hooks set in the ventricular anchor, and having an extension section and an inward curve section, wherein the inner frame has an eversion section; Figure 25 A schematic diagram of the inner frame with outward-flaring sections unfolded along the axial direction. Figure 26 A schematic diagram of an inner frame with slots; Figure 27 This is a schematic diagram of the connecting plate; Figure 28 A perspective view of an atrioventricular valve prosthesis device according to one embodiment; Figure 29 A perspective view of an atrioventricular valve prosthesis device according to one embodiment; Figure 30 A perspective view of the inner and outer frames of one embodiment; Figure 31 A perspective view of the outer frame of one embodiment; Figure 32 A perspective view of the inner and outer frames of one embodiment; Figure 33 A perspective view of the outer frame of one embodiment; Figure 34 A perspective view of the outer frame of one embodiment; Figure 35 A perspective view of a leaflet clip according to one embodiment; Figure 36 A perspective view of a leaflet clip according to another embodiment; Figure 37 A three-dimensional view of the outer frame with a non-circular cross-section; Figure 38 A schematic diagram of a single leaflet; Figure 39 This is a schematic diagram of three leaflets; Figure 40 This is a schematic diagram of a prosthetic valve assembly; Figure 41 A perspective view of the inner and outer frames of one embodiment; Figure 42 A perspective view of the inner and outer frames of one embodiment; Figure 43 A perspective view of an atrioventricular valve prosthesis device according to one embodiment; Figure 44 A perspective view of an atrioventricular valve prosthesis device according to one embodiment; Figure 45 Simplified diagrams of the inner frame and prosthetic valve assembly in three configurations; Figure 46 A simplified diagram of seven configurations of atrioventricular valve prostheses; Figure 47 A front view of an atrioventricular valve prosthesis device according to one embodiment; Figure 48 A top view of an atrioventricular valve prosthesis device according to one embodiment; Figure 49 A schematic diagram illustrating the principle of an atrioventricular valve prosthesis device with adjustable lengths of the central section, extension section, and inner curve section, designed to effectively avoid outflow tract obstruction and prevent paravalvular leakage while ensuring secure anchoring. Detailed Implementation

[0048] In the following description, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments can be modified in various ways without departing from the spirit or scope of the embodiments of this application. Therefore, the drawings and description are considered to be exemplary in nature and not restrictive.

[0049] The orientations used in this application are for the convenience of describing the embodiments of this application and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the embodiments of this application.

[0050] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the embodiments of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0051] In the embodiments of this application, unless otherwise expressly specified and limited, the term "inside" or "outside" the second feature may include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "inside" the second feature means that the first feature is closer to the center line than the second feature. "Outside" the second feature means that the first feature is farther from the center line than the second feature.

[0052] It should also be noted that, unless otherwise explicitly specified and limited, terms such as "installation," "connection," "linking," "fixing," and "setting" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal connection of two components or the interaction between two components. When a component is referred to as being "on" or "below" another component, the component can be located "directly" or "indirectly" on the other component, or there may be one or more intermediary components.

[0053] In the description of this application, it should be noted that the inflow end / side and outflow end / side of the atrioventricular valve prosthesis device are defined according to the blood flow direction during ventricular diastole. The inflow end / side is the end / side closer to the blood inflow side or closer to the atrium, and the outflow end / side is the end / side closer to the blood outflow side or closer to the ventricle. Each component of the atrioventricular valve prosthesis device has an atrial end relatively closer to the atrium and a ventricular end relatively closer to the ventricle, depending on the blood flow direction. The position of each component closest to the atrium is called the atrial apex, and the position closest to the ventricle is called the ventricular apex. Axial direction refers to the direction parallel to the line connecting the centers of the outflow end and the inflow end; radial direction refers to the direction perpendicular to the axial direction; and circumferential direction refers to the direction around the circumference. In this application, the angle between a component and the axis is calculated using the smaller of the two angles.

[0054] The following disclosure provides many different implementations or examples for carrying out different structures of the embodiments of this application. To simplify the disclosure of the embodiments of this application, components and arrangements of specific examples are described below. Of course, these are merely examples and are not intended to limit the embodiments of this application. Furthermore, reference numerals and / or reference letters may be repeated in different examples of the embodiments of this application; such repetition is for simplification and clarity and does not in itself indicate a relationship between the various implementations and / or arrangements discussed. In this application, unless otherwise specified, features with the same name are identical in structural dimensions.

[0055] The embodiments of this application will now be described in detail with reference to the accompanying drawings.

[0056] The atrioventricular valve prosthesis device of this application has a radially compressed delivery state (also known as the collapsed configuration) and a radially expanded natural state (also known as the expanded configuration). In the delivery state, the atrioventricular valve prosthesis device is radially compressed by external force, allowing it to be compressed and inserted into a sheath with a smaller radial dimension, thereby being delivered to the mitral or tricuspid valve of the heart via the delivery device. In the natural state, the atrioventricular valve prosthesis device is not subjected to external force and expands radially naturally. Unless otherwise specified, the structural features of the atrioventricular valve prosthesis device described herein are those in the natural state.

[0057] The atrioventricular valve prosthesis device of this application can replace the mitral or tricuspid valve via a vascular or transapical approach. Once in place, the sheath is withdrawn, causing the atrioventricular valve prosthesis device to expand without external constraint, thereby fixing the atrioventricular valve prosthesis device at the mitral or tricuspid valve. Figure 1 This diagram illustrates the implantation of an atrioventricular valve prosthesis into the mitral valve. Figure 2 A schematic diagram is shown after the atrioventricular valve prosthesis device is implanted into the tricuspid valve.

[0058] The atrioventricular valve prosthesis device of this application can be used for the replacement of the mitral or tricuspid valve in humans or animals.

[0059] like Figures 3 to 49 As shown, the atrioventricular valve prosthesis device of this application includes an outer frame 1, an inner frame 2 fixedly disposed within the outer frame 1, a prosthetic valve assembly 3 fixedly disposed within the inner frame 2, and a skirt 5 for sealing. The outer frame 1 and inner frame 2 have a support-like structure and define a blood flow lumen along their longitudinal axis, which extends substantially from the inflow end to the outflow end of the atrioventricular valve prosthesis device. The inner frame 2 is configured to accommodate the prosthetic valve assembly 3, while the outer frame 1 surrounding the inner frame 2 is configured to fix the atrioventricular valve prosthesis device to the natural tissue of the heart, specifically the natural valve and surrounding subannular tissue, during implantation. The atrioventricular valve prosthesis device of this application can be considered to have a dual-support structure.

[0060] The prosthetic valve assembly 3, supported by the inner frame 2, regulates blood flow through it. When deployed in situ, the prosthetic valve assembly 3 in the closed state is configured to block blood flow in one direction to regulate blood flow through the blood flow lumen of the inner frame 2. The skirt 5 includes an inner skirt disposed on the inner wall and / or outer wall of the inner frame 2, which is configured to allow blood to flow from the atrium through the blood flow lumen of the prosthetic valve assembly 3 to the ventricle when the prosthetic valve assembly 3 is in the open state.

[0061] like Figure 9 , 10As shown in 13, 15, and 37, the outer frame 1 includes a central portion 12 and an atrial portion 13 and a ventricular portion 14 formed at opposite axial ends of the central portion 12. The atrial portion 13 includes a plurality of atrial anchors 131 arranged circumferentially along the central portion 12 and extending radially outward. The cross-sectional dimensions of the atrial portion 13 gradually decrease from the atrial direction to the ventricular direction (i.e., from the inflow side to the outflow side). The ventricular portion 14 includes a plurality of ventricular anchors 141 distributed circumferentially along the central portion 12 and discontinuously arranged. The ventricular anchors 141 extend radially outward relative to the central portion 12. The cross-sectional dimensions of the space formed by the plurality of ventricular anchors 141 gradually increase from the atrial direction to the ventricular direction (i.e., from the inflow side to the outflow side). The central portion 12 may be barrel-shaped, with a constant cross-sectional dimension from the atrial direction to the ventricular direction (i.e., from the inflow side to the outflow side). The cross-section may be circular or non-circular, matching the shape of the mitral or tricuspid valve (e.g., [missing information]). Figure 37 (As shown). The central portion 12 can also have a cross-sectional dimension that gradually decreases from the atrial direction to the ventricular direction (i.e., from the inflow side to the outflow side) (e.g. Figure 46 (G configuration in the model). When the atrioventricular valve prosthesis is in the expanded state, at least a portion of the outer surface of the outer frame 1 is configured to rest against the natural tissue of the heart to fix the outer frame 1, thereby fixing the prosthetic valve assembly 3.

[0062] Furthermore, the atrial anchor 131 has more units than the ventricular anchor 141, thus ensuring the anchoring force between the prosthetic valve assembly 3 and the atria and ventricles of the heart while avoiding the influence of the ventricular portion 14 on the outflow side blood flow, preventing obstruction, and avoiding paravalvular leakage. When the prosthetic valve assembly 3 is implanted into the mitral or tricuspid valve, the central portion 12 is configured to align with the native valve orifice, and the ventricular anchor 141 and atrial anchor 131 are configured to compress the native heart tissue therebetween. Specifically, the atrial anchor 131 is anchored on the atrial side, and the ventricular anchor 141 is anchored on the ventricular side (e.g., ...). Figure 1 and Figure 2 (As shown). In some embodiments, the number of ventricular anchors 141 may be 2, 3, 4 or 5.

[0063] In some embodiments, the ventricular portion 14 further includes at least one extension segment 142 extending axially along the central portion 12, wherein when there are multiple extension segments 142, the multiple extension segments 142 are arranged circumferentially spaced along the central portion 12. For example, the number of extension segments 142 may be one, two, three, or four. The circumferential lengths of the multiple extension segments 142 may be the same or different.

[0064] The circumferential length of all extension segments 142 accounts for 1 / 6 to 5 / 6 of the total circumference of the central portion 12. The circumferential length of the extension segments 142 and the total circumference of the central portion 12 refer to the circumferential length at the junction of the extension segments 142 and the central portion 12. For example, when the cross-section of the central portion 12 is circular, the total circumference of the central portion 12 is the circumference of the circle at the junction of the extension segments 142 and the central portion 12, and the circumferential length of the extension segment 142 is the length of a local arc on that circle. When there are multiple extension segments 142, the circumferential length of each extension segment 142 is the sum of the lengths of all arc segments. In some embodiments, the circumferential length of all extension segments 142 accounts for 5 / 12 to 5 / 6 of the total circumference of the central portion 12, and the circumferential length of one extension segment 142 accounts for 1 / 6 to 2 / 3 of the total circumference of the central portion 12.

[0065] The total axial length B of the central portion 12 and the extension 142 is 5-20 mm, wherein the total axial length of the central portion 12 and the extension 142 refers to the distance from the atrial tip of the central portion 12 to the ventricular tip of the extension 142. In some embodiments, the total axial length B of the central portion 12 and the extension 142 is 10-16 mm.

[0066] In some embodiments, the ventricular anchor 141 and the extension 142 together form a closed-loop structure. In other embodiments, the ventricular anchor 141 and the extension 142 are circumferentially spaced apart, with a gap between them. The ventricular anchor 141, the gap, and the extension 142 are arranged circumferentially.

[0067] The outer frame 1 with extension 142 is anchored at the mitral valve position, wherein the extension corresponds to the CC position of the mitral valve, thereby better adapting to the structure of the original mitral valve and increasing circumferential sealing performance.

[0068] In some embodiments, the ventricular portion 14 further includes at least one inwardly curved segment 143 radially concave from the central portion 12. When there are multiple inwardly curved segments 143, they are spaced apart circumferentially along the central portion 12. For example, the number of inwardly curved segments 143 can be one, two, three, four, or five. The circumferential lengths of the multiple inwardly curved segments 143 can be the same or different. In this embodiment, the outer frame 1 can be formed into a basic hourglass shape.

[0069] The circumferential length of all inner curved segments 143 accounts for 1 / 6 to 2 / 3 of the total circumference of the central portion 12. The circumferential length of the inner curved segments 143 and the total circumference of the central portion 12 refer to the circumferential length at the location where the inner curved segments 143 and the central portion 12 connect. When there are multiple inner curved segments 143, the circumferential length of each inner curved segment 143 is the sum of the lengths of all the arc segments. In some embodiments, the circumferential length of all inner curved segments 143 accounts for 1 / 4 to 2 / 3 of the total circumference of the central portion 12.

[0070] The total axial length A of the central portion 12 and the inner bend 143 is 3-18 mm, wherein the total axial length of the central portion 12 and the inner bend 143 refers to the distance between the atrial tip of the central portion 12 and the ventricular tip of the inner bend 143. In some embodiments, the total axial length A of the central portion 12 and the inner bend 143 is 5-18 mm.

[0071] In some embodiments, the ventricular anchor 141 and the inwardly curved segment 143 together form a closed-loop structure, for example, Figure 5 A schematic diagram is shown showing the ventricular portion 14 consisting of ventricular anchors 141 and inner curved sections 143, wherein there are three ventricular anchors 141 and three inner curved sections 143, with each ventricular anchor 141 connected to one inner curved section 143 at each of its two circumferential ends. In other embodiments, the ventricular anchors 141 and inner curved sections 143 are circumferentially spaced apart, with gaps between them, and the ventricular anchors 141, gaps, and inner curved sections 143 are arranged circumferentially.

[0072] The outer frame 1 with an inwardly curved segment 143 is anchored at the location of the outflow tract of the ventricle to reduce obstruction of the outflow tract.

[0073] In some embodiments, the ventricular end of the inner frame 2 is fixedly connected to the inner curved segment 143. The fixed connection can be achieved using conventional connection methods in the prior art, such as rivets or sutures. In some embodiments, the connection point between the inner frame 2 and the outer frame 1 is radially aligned with the tip of the inner curved segment 143, that is, the ventricular end of the inner frame 2 is fixedly connected to the ventricular tip of the inner curved segment 143.

[0074] In some embodiments, the ventricular portion 14 further includes an extension 142 extending axially along the central portion 12 and an inwardly curved portion 143 radially concave from the central portion 12. The number and arrangement of the extensions 142, and the number and arrangement of the inwardly curved portions 143 are as described above and will not be repeated here.

[0075] In some embodiments, the ventricular anchor 141, the extension 142, and the inwardly curved section 143 together constitute a closed-loop structure. For example... Figure 3As shown, there are two extension segments 142, three inwardly curved segments 143, and three ventricular anchors 141. Those skilled in the art will understand that the number of ventricular anchors 141, extension segments 142, and inwardly curved segments 143 can be adjusted as needed. In other embodiments, there is a gap between the ventricular anchors 141 and the extension segments 142, or a gap between the ventricular anchors 141 and the inwardly curved segments 143, or a gap between the extension segments 142 and the inwardly curved segments 143, or gaps between each pair of ventricular anchors 141, extension segments 142, and inwardly curved segments 143.

[0076] In some embodiments, the atrial end of the inner frame 2 and the atrial end of the outer frame 1 are fixedly connected by connectors (e.g., Figure 46 As shown in configuration B). In some embodiments, the connector may be formed at the atrial end of the central portion 12 and radially concave inward. The atrial end of the inner frame 2 is fixedly connected to the connector of the outer frame 1 by connecting members (e.g., rivets, sutures). Further, the atrial tip of the inner frame 2 is fixedly connected to the connector of the outer frame 1 by connecting members (e.g., rivets, sutures). In this embodiment, the inner frame 2 is substantially cylindrical, such as... Figure 14 , 17 As shown in Figure 19. In other embodiments, the connector may also be formed at the atrial end of the inner frame (2) and extend radially outward. The atrial end of the central portion 12 is fixedly connected to the connector of the inner frame 2 by connecting members (e.g., rivets, sutures). Further, the atrial tip of the central portion 12 is fixedly connected to the connector of the inner frame 2 by connecting members (e.g., rivets, sutures). The connector is formed both at the atrial end of the central portion 12 and radially concave, and at the atrial end of the inner frame 2 and radially outward.

[0077] In other embodiments, the ventricular end of the inner frame 2 and the ventricular end of the outer frame 1 are fixedly connected by a connector (e.g. Figure 46 (As shown in configurations other than configuration B). In some embodiments, the connector can be formed at the ventricular end of the inner frame 2 and extend radially outward. The ventricular end of the central portion 12 is fixedly connected to the connector of the inner frame 2 by connecting members (e.g., rivets, sutures). Further, the ventricular tip of the central portion 12 is fixedly connected to the connector of the inner frame 2 by connecting members (e.g., rivets, sutures). The connector can also be formed at the ventricular end of the central portion 12 and be radially concave inward. In this case, the connector is the inner curved section 143 described above, and the ventricular end of the inner frame 2 is fixedly connected to the inner curved section 143. The connector is formed at the ventricular end of the inner frame 2 and extends radially outward, and also formed at the ventricular end of the central portion 12 and is radially concave inward, as shown in the example. Figure 44 As shown.

[0078] In embodiments where a connector is formed at the atrial or ventricular end of the inner frame 2, the inner frame 2 includes a cylindrical main body segment 21 and an outwardly flared segment 22 that radially expands outward from the atrial or ventricular end of the main body segment 21. This outwardly flared segment 22 is the connector. The expansion angle of the outwardly flared segment 22 is adjusted according to the connection requirements between the inner frame 2 and the outer frame 1. Figure 20 and 21 A schematic diagram is shown showing the everted segment 22 of the inner frame 2 formed at the ventricular end of the main body segment 21. In some embodiments, the everted segment 22 is located on a portion of the circumferential arc of the main body segment 21, that is, the everted segment 22 is only provided in a portion of the inner frame 2, with no support structure in the remaining area, thereby cooperating with the inwardly curved segment 143 of the ventricular portion 14 of the outer frame 1, which is particularly suitable for the anatomical structure of the mitral valve and reduces outflow tract obstruction. In other embodiments, the everted segment 22 is located on the entire circumferential arc of the main body segment 21, for better suitability for the tricuspid valve.

[0079] In some embodiments, the angle between the eversion segment 22 and the axis of the atrioventricular valve prosthesis device is 45-80°.

[0080] Of course, in addition to the inner bend section 143 and the outer bend section 22 mentioned above, which can be used as connectors, connectors can also be additional components.

[0081] In the aforementioned connection methods of the inner frame 2 and outer frame 1, the inner frame 2 and the central portion 12 of the outer frame 1 are spaced apart; when the atrial end of the inner frame 2 is connected to the outer frame 1, the ventricular end of the inner frame 2 is also spaced apart from the outer frame 1; when the ventricular end of the inner frame 2 is connected to the outer frame 1, the atrial end of the inner frame 2 is also spaced apart from the outer frame 1. The outer frame 1 may deform when implanted within the natural mitral or tricuspid annulus, and / or expand and contract in response to the movement of the natural tissue. By maintaining the distance from the inner frame 2, the inner frame 2 is allowed to remain relatively stationary and undeformed. Therefore, the inner frame 2 is isolated from external forces, allowing the prosthetic valve assembly 3 to more effectively replicate the function of the natural mitral / tricuspid valve. Furthermore, the distance from the outer surface of the inner frame 2 to the inner surface of the central portion 12 is 1-15 mm.

[0082] The outer frame 1 includes a support-like structure composed of multiple units defined by a plurality of pillars and struts. The pillars may be linear pillars, and the struts may be V-shaped or U-shaped struts. In some embodiments, the ends of the struts in two adjacent units are connected to form a plurality of rhomboid units. The connection point between the outer frame 1 and the inner frame 2 may be located at the midpoint of the rhomboid unit. The ventricular anchor 141 and the atrial anchor 131 may include a plurality of pillars and V / U-shaped struts. A schematic diagram of the outer frame 1 unfolded axially is shown below. Figure 11 As shown, the schematic diagram of the outer frame 1 before heat treatment after processing is as follows. Figure 12 As shown.

[0083] The atrial portion 13 includes multiple atrial units forming peaks and valleys in the circumferential direction, with one V / U-shaped strut constituting one atrial unit. In embodiments where the atrial portion 13 includes only atrial anchors 131, one atrial unit is one atrial anchor 131. In embodiments where the atrial portion 13 includes both atrial anchors 131 and connectors, the number of atrial units is the sum of the number of atrial anchors 131 and the number of connectors. The ventricular portion 14 includes multiple ventricular units forming peaks and valleys in the circumferential direction, with one V / U-shaped strut constituting one ventricular unit. In embodiments where the ventricular portion 14 includes only ventricular anchors 141, one ventricular unit is one ventricular anchor 141. In embodiments where the ventricular portion 14 includes both ventricular anchors 141 and extensions 142, each extension 142 includes one or more V / U-shaped struts, and the number of ventricular units is the sum of the number of ventricular anchors 141 and the number of V / U-shaped struts in the extension 142. In embodiments where the ventricular portion 14 includes a ventricular anchor 141 and an inner bend 143, each inner bend 143 includes one or more V / U-shaped struts, and the number of ventricular units is the sum of the number of ventricular anchors 141 and the number of V / U-shaped struts in the inner bend 143. In embodiments where the ventricular portion 14 includes a ventricular anchor 141, an extension 142, and an inner bend 143, the number of ventricular units is the sum of the number of ventricular anchors 141, the number of V / U-shaped struts in the extension 142, and the number of V / U-shaped struts in the inner bend 143.

[0084] In some embodiments, the number of atrial units is divisible by 3, the number of ventricular units is divisible by 2 and / or 3, and the number of ventricular units is greater than the number of atrial units. For example, there may be 30 ventricular units and 15 atrial units. There may also be 24 ventricular units and 12 atrial units.

[0085] The inner frame 2 includes a support-like structure composed of multiple units defined by a plurality of pillars and struts. The pillars can be linear pillars, and the struts can be V-shaped or U-shaped struts. In some embodiments, the number of pillars can be the same as the number of atrial units; for example, there can be 15 pillars or 12 pillars. In some embodiments, the ends of the struts in adjacent units are connected to form multiple rhomboid units. A schematic diagram of the inner frame 2 unfolded axially is shown below. Figure 18 and 25 As shown, Figure 18 The inner frame 2 shown is roughly cylindrical after molding. Figure 25 The inner frame 2 shown, after being formed, includes a cylindrical main body section 21 and an outwardly flared section 22.

[0086] In some embodiments, the angle between the atrial anchor 131 and the axis of the atrioventricular valve prosthesis device is 45-80°. The angle between the ventricular anchor 141 and the axis of the atrioventricular valve prosthesis device is 45-80°. The tip of the atrial anchor 131 points towards the atrium, and the tip of the ventricular anchor 141 points towards the ventricle. Further, the deployment angle of the ventricular anchor 141 is greater than that of the atrial anchor 131.

[0087] In some embodiments, the maximum cross-sectional area of ​​the atrial portion 13 is greater than the maximum cross-sectional area of ​​the ventricular portion 14, that is, the area of ​​the cross-section where the atrial tip of the atrial anchor 131 is located is greater than the area of ​​the cross-section where the ventricular tip of the ventricular anchor 141 is located. In some embodiments, the maximum cross-sectional area of ​​the atrial portion 13 is 3-20% larger than the maximum cross-sectional area of ​​the ventricular portion 14. In some embodiments, the outer diameter of the ventricular anchor 141 may be less than 55 mm. When the outline enclosed by the ventricular tip of the ventricular anchor 141 is non-circular, its outer diameter refers to the maximum value of the radial dimension of the outline enclosed by the ventricular tip of the ventricular anchor 141.

[0088] In some embodiments, the inner frame 2 and the outer frame 1 have a self-expanding configuration, meaning that when the sheath is retracted and the atrioventricular valve prosthesis is freed from external force restraint, the atrioventricular valve prosthesis can naturally expand to an unfolding configuration.

[0089] The outer frame 1 is configured to shorten as it expands from the collapsed configuration to the expanded configuration. Furthermore, the outer frame 1 is configured to shorten along the axial direction of the atrioventricular valve prosthesis device as it expands from the collapsed configuration to the expanded configuration, in some embodiments by 10-30%. The inner frame 2 is configured to not shorten substantially along the axial direction as it expands from the collapsed configuration to the expanded configuration.

[0090] The inner frame 2 and outer frame 1 can be made of a variety of biocompatible materials, such as stainless steel, nickel-titanium alloy, cobalt-chromium alloy, various polymers, pyrolytic carbon, polytetrafluoroethylene, or combinations thereof. Material selection should consider both compressing the prosthesis to a smaller diameter for catheter delivery and its ability to self-recover to a preset expanded shape after release. In some implementation schemes, shape memory materials can be used to achieve self-expansion properties. These materials, after processing, can "memorize" the expanded configuration, thus automatically returning to their working state after release.

[0091] In some embodiments, the atrioventricular valve prosthesis device also includes a plurality of fixation hooks 4, each fixation hook 4 extending radially outward and pointing toward the atrium.

[0092] In some embodiments, such as Figures 3 to 5 As shown, multiple fixing hooks 4 are fixedly disposed on the ventricular anchor 141, specifically at the ventricular tip of the ventricular anchor 141. In other embodiments, such as Figure 6 as well as Figures 28-30As shown, multiple fixing hooks 4 are fixedly disposed on the outer wall of the central portion 12. Further, two or three rings of fixing hooks 4 are arranged along the axial direction of the central portion 12, each ring having multiple fixing hooks 4 evenly distributed circumferentially, with adjacent rings of fixing hooks 4 staggered circumferentially. In some other embodiments, such as... Figure 34 as well as Figures 43-44 As shown, fixing hooks 4 are provided on the outer walls of both the ventricular anchor 141 and the central portion 12.

[0093] The ratio of the radius of curvature to the thickness of each fixation hook 4 is between 4:1 and 6:1. The thickness of each fixation hook 4 is between 0.2 mm and 1 mm. The angle between each fixation hook 4 and the axis of the atrioventricular valve prosthesis device is 50-80°, for example, 65°.

[0094] Multiple fixing hooks 4 may be integrally formed with the outer frame 1. In some embodiments, the fixing hooks 4 extend from the vertices of the rhomboid units of the outer frame 1, and further, the fixing hooks 4 may extend from the vertices of each rhomboid unit in the circumferential direction surrounding the outer frame 1.

[0095] In some implementations, such as Figure 43 As shown, the atrioventricular valve prosthesis device also includes a radiopaque body 6 disposed at the atrial anchor 131. The radiopaque body 6 can be of various shapes, as long as it facilitates the physician's understanding of the position of the atrioventricular valve prosthesis device using existing imaging methods. For example, the radiopaque body 6 can be spring-shaped, woven, and / or composed of multiple small balls connected together.

[0096] In some embodiments, the atrioventricular valve prosthesis device further includes a skirt 5 for sealing on the inner and / or outer wall surfaces of the inner frame 2, and on the inner and / or outer wall surfaces of the portion of the outer frame 1 excluding the ventricular anchor 141. In some embodiments, the imaging body 6 is covered with a skirt.

[0097] In some embodiments, the atrioventricular valve prosthesis device further includes a leaflet clip 7 for holding the native leaflet.

[0098] Figure 35 A leaflet clip 7 is shown, comprising a clip body 71 that is curved in an arc and has opposing first and second ends. The clip body 71 has a hollow frame structure; specifically, the clip body 71 is elongated. The first end of the clip body 71 has a mounting portion 72 for fixed connection with the ventricular portion 14 or the central portion 12 near the ventricle. The second end of the clip body 71 points towards the atrium, and a through hole 73 is formed on the second end of the clip body 71 for a wire to pass through, enabling the clip body 71 to be pulled towards the ventricle. The mounting portion 72 can be an elongated rod extending from the first end of the clip body 71 toward the second end, or it can be any other structure.

[0099] Figure 36 Another valve clip 7 with a different structure is shown. The valve clip 7 includes a mounting portion 72 for fixed connection with the ventricular portion 14 or the central portion 12, and a clip body 71 that is elongated and has multiple hollow structures distributed along the axial direction. The first end of the clip body 71 is curved and fixedly connected to the ventricular end of the mounting portion 72 or integrally formed therein. The second end of the clip body 71, opposite to the first end, points towards the atrium and allows a suture to pass through so that the clip body 71 can be pulled towards the ventricle. The mounting portion 72 can be an elongated hollow rod extending from the first end of the clip body 71 towards the second end, or it can be any other structure. The clip body 71 can be a fishbone-shaped structure or a structure formed by multiple hollow rings connected in series along the axial direction.

[0100] In some embodiments, the leaflet clip 7 is located at the position of the longest inner curved segment 143 of the outer frame.

[0101] The structure for fixing the inner frame 2 to the prosthetic valve assembly 3 can adopt any method existing in the art. In this application, some embodiments of the inner frame 2 have multiple through slots 211 on the main body segment 21, such as... Figure 26 As shown. The prosthetic valve assembly 3 includes multiple replacement leaflets. Each leaflet has a leaflet arm that passes through one of the multiple slots 211.

[0102] In some embodiments, a plurality of slots 211 may be located in a portion of the inner frame 2 extending beyond the outer frame 1 in the ventricular direction. The atrioventricular valve prosthesis device also includes a plurality of connecting plates 8 that cooperate with the slots 211 to secure the leaflets to the inner frame 2. Each connecting plate 8 has a plurality of channels 81 formed on its side surface extending toward the center of the connecting plate 8. The plurality of channels 81 may be substantially straight, such as... Figure 27 As shown. Each connecting plate 8 is aligned circumferentially and axially with one of a plurality of slots 211 to form a connecting attachment mechanism. The number of channels 81 can be 0-12. In some embodiments, each connecting attachment mechanism includes at least one suture, which may be disposed around the inner frame 2, through a plurality of notches, and around the connecting plate 8.

[0103] Each slot 211 may be located within a strut of the axially extending inner frame 2. Leaflet arms may pass through multiple slots 211. Leaflet arms may further wrap around the outer periphery of the inner strut of the inner frame 2. Multiple slots 211 may be equidistantly arranged around the circumference of the inner frame 2. Each of the multiple slots 211 may be positioned towards the ventricular end of the inner frame 2. The atrial edges of the leaflets may be sutured around the inner circumference of the inner frame 2. The prosthetic valve assembly 3 may also include leaflet protectors, which may be made of smooth fabric and may be configured to protect the respective leaflets from the influence of the inner circumference of the inner frame 2.

[0104] In some embodiments, the inner frame 2 has three circumferentially spaced pillars on the three pillars surrounding the inner frame 2 with a connecting attachment mechanism, and three replacement leaflets 31 are fixed to the inner frame 2 at the connecting attachment point.

[0105] In some implementations, such as Figure 38 The three lobes 31 shown are spliced ​​together to form a shape like... Figure 40 The prosthetic valve component 3 shown can also be as follows: Figure 39 The entire structure shown has three leaflets 31, forming as shown. Figure 40 The prosthetic valve assembly 3 is shown.

[0106] In summary, the atrioventricular valve prosthesis device of this application overcomes many bottlenecks in current interventional treatment of heart valves. It has the advantages of simplified structure, convenient operation, less trauma and higher safety. It also effectively reduces the risk of paravalvular leakage and outflow tract obstruction after implantation of the atrioventricular valve prosthesis device, effectively improves the stability of the atrioventricular valve prosthesis device after implantation, and is less prone to displacement of the atrioventricular valve prosthesis device.

[0107] The above embodiments are only for illustrating the technical concept and features of the present invention, and are intended to enable those skilled in the art to understand the content of the present invention and implement it accordingly. They should not be construed as limiting the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. An atrioventricular valve prosthesis device, characterized in that: The device includes an outer frame (1), an inner frame (2) fixedly disposed within the outer frame (1), and a prosthetic valve assembly (3) fixedly disposed within the inner frame (2). The outer frame (1) includes a central portion (12) and an atrial portion (13) and a ventricular portion (14) formed at both axial ends of the central portion (12). The atrial portion (13) includes a plurality of atrial anchors (131) arranged circumferentially along the central portion (12) and extending radially outward. The ventricular portion (14) includes a plurality of ventricular anchors (141) distributed circumferentially along the central portion (12) and discontinuously disposed. The plurality of ventricular anchors (141) extend radially outward relative to the central portion (12), and the number of units of the atrial anchors (131) is greater than the number of units of the ventricular anchors (141).

2. The atrioventricular valve prosthesis device according to claim 1, characterized in that: The ventricular portion (14) further includes at least one extension segment (142) extending axially along the central portion (12). When there are multiple extension segments (142), the multiple extension segments (142) are arranged circumferentially spaced along the central portion (12), and the circumferential length of all the extension segments (142) accounts for 1 / 6 to 5 / 6 of the total circumference of the central portion (12).

3. The atrioventricular valve prosthesis device according to claim 2, characterized in that: The total axial length of the central portion (12) and the extension section (142) is 5-20 mm.

4. The atrioventricular valve prosthesis device according to claim 2 or 3, characterized in that: The circumferential length of all the extension segments (142) accounts for 5 / 12 to 5 / 6 of the total circumference of the central portion (12); or, the circumferential length of one of the extension segments (142) accounts for 1 / 6 to 2 / 3 of the total circumference of the central portion (12); or, the total axial length of the central portion (12) and the extension segments (142) is 10-16 mm.

5. The atrioventricular valve prosthesis device according to claim 1, characterized in that: The ventricular portion (14) further includes at least one inwardly curved segment (143) that is radially concave from the central portion (12). When there are multiple inwardly curved segments (143), the multiple inwardly curved segments (143) are arranged circumferentially at intervals along the central portion (12), and the circumferential length of all the inwardly curved segments (143) accounts for 1 / 6 to 2 / 3 of the total circumference of the central portion (12).

6. The atrioventricular valve prosthesis device according to claim 5, characterized in that: The total axial length of the central portion (12) and the inner curved section (143) is 3-18 mm.

7. The atrioventricular valve prosthesis device according to claim 5 or 6, characterized in that: The circumferential length of all the inner bends (143) accounts for 1 / 4 to 2 / 3 of the total circumference of the central portion (12); or, the total axial length of the central portion (12) and the inner bends (143) is 5-18 mm.

8. The atrioventricular valve prosthesis device according to claim 5, characterized in that: The ventricular end of the inner frame (2) is fixedly connected to the inner curved section (143), and the inner frame (2) is spaced apart from the central part (12) and the atrial part (13) of the outer frame (1).

9. The atrioventricular valve prosthesis device according to claim 8, characterized in that: The connection point where the inner frame (2) is fixedly connected to the outer frame (1) is radially aligned with the tip of the inner curved section (143).

10. The atrioventricular valve prosthesis device according to claim 8, characterized in that: The distance from the outer surface of the inner frame (2) to the inner surface of the central part (12) is 1-15 mm.

11. The atrioventricular valve prosthesis device according to claim 1, characterized in that: The ventricular portion (14) further includes an extension (142) extending axially along the central portion (12) and an inwardly curved portion (143) radially concave from the central portion (12), the ventricular anchor (141), the extension (142) and the inwardly curved portion (143) together forming a closed-loop structure.

12. The atrioventricular valve prosthesis device according to claim 1, characterized in that: The atrial end of the inner frame (2) and the atrial end of the outer frame (1) are fixedly connected by a connector, or the ventricular end of the inner frame (2) and the ventricular end of the outer frame (1) are fixedly connected by a connector.

13. The atrioventricular valve prosthesis device according to claim 12, characterized in that: The connector is formed at the atrial end of the central portion (12) and is radially concave inward, or the connector is formed at the atrial end of the inner frame (2) and is radially outward, or the connector is formed at the ventricular end of the inner frame (2) and is radially outward, or the connector is formed at the ventricular end of the central portion (12) and is radially concave inward.

14. The atrioventricular valve prosthesis device according to claim 1, characterized in that: The inner frame (2) includes a cylindrical main body segment (21) and an everted segment (22) extending radially outward from the atrial or ventricular end of the main body segment (21), the everted segment (22) being located in part or all of the circumferential arc segment of the main body segment (21); and / or, The angle between the atrial anchor (131) and the axis of the atrioventricular valve prosthesis device is 45-80°, and / or the angle between the ventricular anchor (141) and the axis of the atrioventricular valve prosthesis device is 45-80°, and / or the unfolding angle of the ventricular anchor (141) is greater than the unfolding angle of the atrial anchor (131); and / or the maximum cross-sectional area of ​​the atrial portion (13) is greater than the maximum cross-sectional area of ​​the ventricular portion (14); and / or the maximum cross-sectional area of ​​the atrial portion (13) is 3-20% larger than the maximum cross-sectional area of ​​the ventricular portion (14); and / or the tip of the atrial anchor (131) points towards the atrium; and / or the tip of the ventricular anchor (141) points towards the ventricle.

15. The atrioventricular valve prosthesis device according to claim 1, characterized in that: The atrial portion (13) includes multiple atrial units forming peaks and valleys in the circumferential direction, and the ventricular portion (14) includes multiple ventricular units forming peaks and valleys in the circumferential direction. The number of atrial units is divisible by 3, the number of ventricular units is divisible by 2 and / or 3, and the number of ventricular units is greater than the number of atrial units.

16. The atrioventricular valve prosthesis device according to claim 1, characterized in that: The atrioventricular valve prosthesis device further includes a plurality of fixing hooks (4), which are fixedly disposed on the outer wall of the ventricular anchor (141) and / or the central portion (12), and each fixing hook (4) extends radially outward and points towards the atrium.

17. The atrioventricular valve prosthesis device according to claim 16, characterized in that: The ratio of the radius of curvature to the thickness of each of the fixation hooks (4) is between 4:1 and 6:1; and / or the thickness of each of the fixation hooks (4) is between 0.2 mm and 1 mm; and / or the angle between each of the fixation hooks (4) and the axis of the atrioventricular valve prosthesis device is 50-80°.

18. The atrioventricular valve prosthesis device according to claim 1, characterized in that: The atrioventricular valve prosthesis device further includes a sealing skirt (5) disposed on the inner wall surface and / or outer wall surface of the inner frame (2), and on the inner wall surface and / or outer wall surface of the outer frame (1) excluding the ventricular anchor (141); and / or, The atrioventricular valve prosthesis device further includes a contrast agent (6) disposed at the atrial anchor (131), the contrast agent (6) being spring-shaped, woven, and / or composed of multiple interconnected small balls; and / or, The atrioventricular valve prosthesis device also includes a leaflet clip (7) for holding the original leaflet. The leaflet clip (7) includes a clip body (71) that is curved in an arc and has opposing first and second ends. The clip body (71) has a hollow frame structure. The first end of the clip body (71) has a mounting part (72) for fixed connection with the ventricular portion (14) or the central portion (12). The second end of the clip body (71) points towards the atrium. Furthermore, the second end of the clip body (71) has a through hole (73) for a wire to pass through so that the clip body (71) can be pulled towards the ventricle. Alternatively, The leaflet clip (7) includes a mounting part (72) for fixed connection with the ventricular portion (14) or the central portion (12), and a clip body (71) that is elongated and has a plurality of hollow structures distributed along the axial direction. The first end of the clip body (71) is curved and fixedly connected to the ventricular end of the mounting part (72) or integrally formed. The second end of the clip body (71) opposite to the first end points towards the atrium and allows a wire to pass through so that the clip body (71) can be pulled towards the ventricle.

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