Prosthetic heart valve for multiple sites and method of assembling same

Abstract

The present disclosure relates to a prosthetic heart valve and a method of assembling the same. The heart valve prosthesis comprises a universal core and a core, wherein the universal core can be universally used in different implantation positions and different application scenes; and a specified adapter selected from the plurality of adapters, wherein the adapters are respectively suitable for different application scenarios. The universal core is provided with a plurality of cantilever supporting rods which are flexibly connected through connecting lines to form a valve leaflet structure supporting structure. Compared with various existing heart valve prostheses, the heart valve prosthesis has better flexibility and wider application range, and the time cost and the research and development cost can be saved.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. patent application No. 17 / 852,349, filed on June 28, 2022, entitled “Artificial Heart Valve for Multiple Locations and Multiple Applications,” and U.S. patent application No. 18 / 202,267, filed on May 25, 2023, entitled “Artificial Heart Valve for Multiple Locations and Methods of Assembly Thereof,” and the entire contents of the above two applications are incorporated herein by reference as part of this application. Technical Field

[0003] The present invention relates to the technical field of medical devices, and in particular to an artificial heart valve that can be applied to a variety of application scenarios and an assembling method of the artificial heart valve. Background Art

[0004] Natural heart valves, such as the aortic, pulmonary, mitral, and tricuspid valves, play a critical role in ensuring adequate blood supply and positive flow through the cardiovascular system. Congenital, inflammatory, or infectious diseases can reduce the effectiveness of these heart valves. This damage to the valves can lead to severe cardiovascular damage and even death, and may ultimately require replacement of the natural heart valve with an artificial heart valve, either surgically or through minimally invasive transcatheter implantation.

[0005] There are many known structures of artificial heart valves, such as artificial aortic valves for surgical implantation, artificial aortic valves for transcatheter aortic valve implantation (TAVI), etc. These existing structures of artificial heart valves are developed specifically for each site and each application, and cannot be used universally in various application scenarios. For example, artificial aortic valves for surgical implantation cannot be used for transcatheter implantation, artificial pulmonary valves cannot be implanted as artificial mitral valves, and so on.

[0006] Due to increasingly stringent regulatory requirements, it takes nearly 10 years to bring a newly developed artificial heart valve to market. The R&D and time costs required to develop various artificial heart valve products for different application scenarios are very high. Therefore, it is hoped to achieve an artificial heart valve that can be suitable for multiple application scenarios to a certain extent. Summary of the invention

[0007] In view of this, the object of the present invention is to provide an artificial heart valve, which includes a universal core and an adapter, wherein the universal core can be used in different implantation positions and different application scenarios, and the adapter is selected from one of a plurality of adapters, and the plurality of adapters are respectively suitable for different application scenarios. Compared with various existing artificial heart valves, the artificial heart valve according to the present disclosure has better flexibility and adaptability for a wide range of terminal applications, and can save time and R&D costs.

[0008] According to one aspect of the present disclosure, there is provided an artificial heart valve, comprising:

[0009] The universal core is suitable for different application scenarios, including: an annular stent having a distal end and a proximal end in the axial direction, the stent comprising: a mesh structure as a circumferential side wall of the stent configured to allow the stent to contract or expand in the radial direction, the stent configured to allow blood flow from the proximal end to the distal end; the stent further comprising a plurality of cantilever struts of different lengths, each of the cantilever struts extending from the proximal end to the distal end of the mesh structure;

[0010] a leaflet structure including a plurality of leaflets, each leaflet being attached to the stent and having at least a portion disposed within the stent, the leaflet structure being configured to allow blood to flow from the proximal end to the distal end through the artificial heart valve and inhibit blood from flowing from the distal end to the proximal end through the artificial heart valve;

[0011] a designated adapter, the designated adapter being selected from a plurality of adapters suitable for different application scenarios and configured to anchor the bracket at a target location; based on the plurality of cantilever struts, the bracket is detachably connected to any one of the plurality of adapters,

[0012] The plurality of cantilever struts are flexibly connected via connecting lines to form a support structure for the leaflet structure, and each of the cantilever struts is configured to move in at least three degrees of freedom.

[0013] In some embodiments, each of the leaflets has an arcuate restraining edge for fixing to the stent and a free edge arranged in the stent, and when the free edge of the leaflet is separated from other leaflets among the multiple leaflets, the free edge of the leaflet allows blood to flow through the artificial heart valve along the proximal end to the distal end, and when the free edge of the leaflet contacts other leaflets among the multiple leaflets, the free edge of the leaflet inhibits blood from flowing through the artificial heart valve along the distal end to the proximal end, wherein, based on the connecting line and the multiple cantilever struts, at least a portion of the arcuate restraining edge is folded from the inside of the stent to the outer circumferential surface of the stent so that the arcuate restraining edge wraps the connecting line and the proximal end of the stent.

[0014] In some embodiments, the arcuate constraining edge of each of the leaflets has a lower edge portion located at the proximal end and an opposite side edge portion, each of the side edge portions of the leaflet is fixed to the side edge portion of another adjacent leaflet to form a joint, the free edge of the leaflet extends between the two side edge portions of the arcuate constraining edge, and the contour of the stent at the proximal end matches the lower contour formed by the lower edge portions of multiple leaflets.

[0015] In some embodiments, the mesh structure includes a plurality of first mesh units and a plurality of second mesh units distributed along the circumferential direction, and each of the leaflets is attached to a corresponding second mesh unit or a corresponding cantilever strut and is independent of the adapter.

[0016] In some embodiments, the artificial heart valve also includes a first covering layer, which covers at least a portion of the inner side of the stent and has a skirt-like shape, the first covering layer includes a first part and / or a second part, the first part is sutured to the multiple second grid units and is at least partially sandwiched between the multiple leaflets and the multiple second grid units, and the second part matches the proximal end of the stent in position and shape and is sutured to the corresponding part of the stent.

[0017] In some embodiments, the edge of the first covering layer at the distal end has a contour that matches several frames of the mesh structure, and the several frames include: a distal border of one or more grid units, and the one or more grid units include: a plurality of second grid units and a first grid unit adjacent to each of the second grid units; a proximal border of one or more first grid units that are not adjacent to each of the second grid units; and a rod-shaped border of one or more first grid units adjacent to each of the second grid units, and the rod-shaped border is shared by adjacent first grid units.

[0018] In some embodiments, the first covering layer at least completely covers the plurality of second grid cells, and the first grid cells adjacent to each of the second grid cells, the plurality of cantilevered struts, and / or at least one of the plurality of first grid cells are partially exposed by the first covering layer.

[0019] In some embodiments, the artificial heart valve also includes a second covering layer, which covers the outside of the stent and has a skirt-like shape, the second covering layer includes a first part and / or a second part, the first part of the second covering layer is sewn together with the multiple second grid units and the first part of the first covering layer, and the second part of the second covering layer has a proximal contour that matches the proximal end of the stent in position and shape, and is sewn together with the corresponding part of the stent and the second part of the first covering layer.

[0020] In some embodiments, an edge of the second cover layer at the distal end has a shape that matches a distal border of one or more of the second grid cells.

[0021] In some embodiments, the first covering layer and the second covering layer are integrated into a single covering layer, which is wrapped around the proximal end of the stent based on the connecting line and the multiple cantilever struts, and is at least partially sandwiched between the stent and the multiple leaflets at the proximal end; or, the first covering layer and the second covering layer are different covering layers.

[0022] In some embodiments, the artificial heart valve further comprises a base covering layer which surrounds the inner peripheral surface and / or the outer peripheral surface of the adapter to prevent blood from flowing in a direction other than a direction between the proximal opening and the distal opening of the adapter.

[0023] In some embodiments, the base cover layer is stitched to the first cover layer and / or the second cover layer.

[0024] In some embodiments, at least a portion of the arcuate constraining edge of each leaflet is sutured a distance from an edge of the stent at the proximal end to a corresponding position on the outer circumferential surface of the stent.

[0025] In some embodiments, each of the cantilever struts has an opening (cavity) arranged at the proximal end, and the openings of the multiple cantilever struts are softly connected through the connecting line, and the opening is a hole, a groove or a gap; and / or, the connecting line is a metal wire, a suture or other suitable material.

[0026] According to another aspect of the present disclosure, an assembly method of an artificial heart valve according to an embodiment of the present disclosure is provided, the assembly method comprising: softly connecting the multiple cantilever struts through the connecting line; connecting each of the leaflets to the stent by suturing based on the connecting line and the multiple cantilever struts; and selecting the designated adapter and connecting the designated adapter to the multiple cantilever struts by suturing.

[0027] In some embodiments, each of the leaflets has an arcuate constraint edge and a free edge arranged in the stent, and when the free edge of the leaflet is separated from other leaflets among the multiple leaflets, the free edge of the leaflet allows blood to flow through the artificial heart valve from the proximal end to the distal end, and when the free edge of the leaflet contacts with other leaflets among the multiple leaflets, the free edge of the leaflet inhibits blood from flowing through the artificial heart valve from the distal end to the proximal end, wherein the step of suturing each of the leaflets to the stent by suturing based on the connecting line and the multiple cantilever struts includes: folding at least a portion of the arcuate constraint edge of each leaflet from the inside of the stent to the outer peripheral surface of the stent based on the connecting line and the multiple cantilever struts, so that the arcuate constraint edge wraps the connecting line and the proximal end of the stent; and suturing at least a portion of the arcuate constraint edge to the proximal end of the stent.

[0028] In some embodiments, the mesh structure includes a plurality of first mesh units and a plurality of second mesh units distributed in a circumferential direction, and each of the leaflets is attached to a corresponding second mesh unit and / or a corresponding cantilever strut and is independent of the adapter.

[0029] In some embodiments, the artificial heart valve also includes a first covering layer, which covers at least a portion of the inner side of the stent and has a skirt-like shape, and the assembly method also includes: sewing a first portion of the first covering layer to the multiple second grid units to allow the first portion of the first covering layer to be at least partially sandwiched between the multiple leaflets and the multiple second grid units; and / or, sewing a second portion of the first covering layer to a corresponding portion of the stent, and the second portion of the first covering layer matches the proximal end of the stent in position and shape.

[0030] In some embodiments, the artificial heart valve also includes a second covering layer, which covers the outside of the stent and has a skirt-like shape, and the assembly method also includes: sewing a first portion of the second covering layer with the plurality of second grid units and the first portion of the first covering layer; and / or sewing a second portion of the second covering layer with a corresponding portion of the stent and the second portion of the first covering layer, and the second portion of the second covering layer matches the proximal end of the stent in position and shape.

[0031] In some embodiments, the assembly method also includes: a single-piece covering layer obtained by laser cutting as an integrated covering layer including the first covering layer and the second covering layer, the single-piece covering layer wraps the proximal end of the stent based on the connecting line and the multiple cantilever struts, and is at least partially clamped between the stent and the multiple leaflets at the proximal end; or providing the first covering layer and the second covering layer independently of each other.

[0032] In some embodiments, the artificial heart valve further includes a base cover layer that surrounds the inner circumferential surface and / or the outer circumferential surface of the adapter to prevent blood from flowing in a direction other than a direction between the proximal opening and the distal opening of the adapter.

[0033] In some embodiments, the assembly method further comprises stitching the base cover layer to the first cover layer and / or the second cover layer.

[0034] In some embodiments, the step of suturing at least a portion of the arcuate restraining edge to the proximal end of the stent includes suturing at least a portion of the arcuate restraining edge of each leaflet a distance from the edge of the stent at the proximal end to a corresponding position on the outer peripheral surface of the stent.

[0035] In some embodiments, the assembly method further comprises: coupling a sewing ring to an outer surface of the designated adapter.

[0036] According to the embodiments of the present disclosure, the artificial heart valve and its assembly method mainly include a universal core and an adapter that are independent of each other in structure and function, and the cantilever strut of the universal core is used to be detachably connected to the adapter. The universal core includes a leaflet structure and an annular stent with a cantilever strut and a mesh structure, and is universally applicable to various application scenarios, for example, in independent surgical operations or implantation of transcatheter clamp-type valve delivery. The stent with a mesh structure provides stability for the artificial heart valve, and the leaflet is connected to the cantilever strut and / or distal portion of the stent. According to the specified application scenario, the adapter can be selected from a variety of adapters, which are respectively applicable to various application scenarios and are respectively configured to anchor the universal core at the corresponding implantation position. Each cantilever strut is a free cantilever, which is configured to allow movement in at least three degrees of freedom, and can be slightly deformed facing various adapters in various application scenarios, with little effect on the valve structure. Therefore, the artificial heart valve provided according to the embodiments of the present disclosure has good versatility and flexibility, can significantly save time and R&D costs, improve the utilization efficiency of the production line, and accelerate the clinical application and marketization process of the artificial heart valve.

[0037] In addition, multiple cantilever struts can be flexibly connected through connecting lines to form a support structure for the leaflet structure, which helps to increase the life of the artificial heart valve.

[0038] In some optional embodiments, each cantilever strut may be provided with an opening through which a connecting structure (e.g., a suture or a connecting line) may pass to form a support structure for supporting the leaflet structure, so that each leaflet may be attached to the stent at the proximal end based on the cantilever strut. These openings may also be used to connect to a designated adapter.

[0039] In some optional embodiments, each second grid unit may be provided with a cantilevered strut / opening to further provide stable support for the commissures and / or edges of the leaflets.

[0040] In some optional embodiments, each second grid unit may be provided with a gap for accommodating a corresponding leaflet, so that each leaflet may have a continuous arcuate edge, which can be folded from the internal space of the stent to the outside of the stent without forming a gap, thereby improving the durability and material stability of the leaflet structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The above and other objects, features and advantages of the present disclosure will become more apparent through the following description of embodiments of the present disclosure with reference to the accompanying drawings, in which:

[0042] Figure 1 is a schematic diagram of a cross section of the heart showing the location of the native valve;

[0043] Figure 2 A schematic structural diagram of an artificial heart valve according to an embodiment of the present disclosure is shown;

[0044] Figure 3 and Figure 4 Schematic structural diagrams showing two different adapters that can be selected for use in artificial heart valves according to various embodiments of the present disclosure;

[0045] Figure 5 A schematic structural diagram of an artificial heart valve according to an embodiment of the present disclosure is shown;

[0046] Figure 6 A schematic structural diagram of a bracket according to an embodiment of the present disclosure is shown;

[0047] Figure 7 Show Figure 6 A schematic side view of the bracket shown;

[0048] Figure 8a A partial structural schematic diagram showing a first exemplary structure of a bracket according to an embodiment of the present disclosure;

[0049] Figure 8b A partial structural schematic diagram showing a second exemplary structure of a bracket according to an embodiment of the present disclosure;

[0050] Figure 8c A partial structural schematic diagram showing a third exemplary structure of a bracket according to an embodiment of the present disclosure;

[0051] Fig. 9 A schematic diagram showing a leaflet structure according to an embodiment of the present disclosure;

[0052] Fig.10 A schematic diagram showing a flattened structure of a single leaflet according to an embodiment of the present disclosure is shown;

[0053] Fig.11 A schematic diagram showing a structure of an example of a general core according to an embodiment of the present disclosure;

[0054] Fig.12 Shown at Fig.11 A schematic diagram of a cross-sectional structure of a portion of the universal core at a commissure position along the radial direction of the stent is shown;

[0055] Fig.13 A schematic diagram showing the positional relationship between the first covering layer and the bracket according to an embodiment of the present disclosure;

[0056] Fig.14 for Fig.13 A schematic structural diagram of the first covering layer shown;

[0057] Fig.15A schematic diagram showing the positional relationship between the second covering layer and the bracket according to an embodiment of the present disclosure;

[0058] Fig.16 for Fig.15 A schematic structural diagram of the second covering layer shown;

[0059] Fig.17 A schematic structural diagram of a bracket having a first covering layer and a second covering layer according to an embodiment of the present disclosure is shown;

[0060] Fig.18a for Fig.17 An exemplary cross-sectional schematic diagram of the universal core along line QQ' is shown;

[0061] Fig.18b for Fig.17 Another exemplary cross-sectional schematic diagram of the universal core along line QQ' of the universal core shown;

[0062] Fig.19 A partial structural schematic diagram showing a third exemplary structure of a bracket according to an embodiment of the present disclosure;

[0063] Fig. 20 for Fig.19 A schematic structural diagram of a support with a third covering layer is shown;

[0064] Fig.21 for Fig. 20 An exemplary cross-sectional schematic diagram of the universal core along line YY' is shown;

[0065] Fig. 22 A schematic diagram showing a flattened structure of a single leaflet according to an embodiment of the present disclosure is shown;

[0066] Fig.23 A schematic structural diagram of an artificial heart valve with a sewing ring according to an embodiment of the present disclosure is shown;

[0067] Fig.24 A schematic diagram showing the structure of an artificial heart valve according to an embodiment of the present disclosure when the valve leaflets are in an open state;

[0068] Fig.25 A schematic side view of an artificial heart valve according to an embodiment of the present disclosure when the valve leaflets are in an open state;

[0069] Fig.26 for Fig.25 The schematic diagram of the cross-sectional structure of the artificial heart valve shown is when the leaflets are in the open state. DETAILED DESCRIPTION

[0070] The present disclosure will be described in more detail below with reference to the accompanying drawings. In each of the accompanying drawings, the same / similar elements are represented by the same / similar reference numerals. For the sake of clarity, the various parts in the accompanying drawings are not drawn to scale. In addition, some well-known parts may not be shown in the drawings.

[0071] Several exemplary embodiments of artificial heart valves are disclosed herein and shown in the accompanying drawings. These embodiments should not be construed as limiting the invention in any way. On the contrary, the present disclosure is intended to include all novel and non-obvious features and aspects of the various disclosed embodiments, as well as various combinations and sub-combinations of each other.

[0072] Application Scenario

[0073] Figure 1 is a schematic diagram of a cross section of the heart showing the location of the native valves.

[0074] like Figure 1 As shown, a healthy heart has four chambers, including the left atrium, right atrium, left ventricle and right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The natural valves of the heart include: the mitral valve P2 for connecting the left atrium and the left ventricle, the aortic valve P1 for connecting the left ventricle and the aorta, the tricuspid valve P3 for connecting the right atrium and the right ventricle, and the pulmonary valve P4 for connecting the right ventricle and the pulmonary artery.

[0075] If the natural valve becomes diseased, an artificial heart valve can be implanted into the diseased site through surgery or transcatheter implantation, thereby replacing the natural valve with an artificial heart valve.

[0076] Traditional artificial heart valves are usually developed for a single application scenario, and therefore may only be suitable for a single implantation location (such as the aortic valve location, mitral valve location, tricuspid valve location, or pulmonary valve location), a single implantation method / procedure (such as surgical implantation or transcatheter implantation), and a single implantation condition (such as stenosis or incomplete closure, etc.). Therefore, medical device manufacturers need to develop various products based on different implantation locations, implantation methods, and implantation conditions, which greatly increases the difficulty and cost of research and development, and end users also need to purchase artificial heart valves suitable for different application scenarios based on different needs.

[0077] According to an embodiment of the present disclosure, an artificial heart valve is provided, wherein the artificial heart valve or at least a portion thereof can be used as a universal artificial heart valve, or has a universal core, and the universal artificial heart valve / universal core can be applied to various application scenarios without change, thereby reducing R&D costs and time costs, improving product utilization rates for end users, and accelerating the process of putting artificial heart valve products into clinical practice.

[0078] In some examples, the artificial heart valve provided according to the embodiments of the present disclosure is configured for use in multiple target implantation locations, including but not limited to an aortic valve location, a mitral valve location, a tricuspid valve location, or a pulmonary valve location. In some examples, the artificial heart valve according to the embodiments of the present disclosure is configured to be implantable in one or more ways, including but not limited to surgical implantation or transcatheter implantation. In some embodiments, the artificial heart valve according to the embodiments of the present disclosure is configured to be suitable for treating more than one condition, including but not limited to stenosis or insufficiency.

[0079] Basic structure

[0080] Figure 2 A schematic structural diagram of an artificial heart valve according to an embodiment of the present disclosure is shown.

[0081] like Figure 2 As shown, the artificial heart valve 1000 mainly includes a universal core and an adapter 300. The adapter 300 is functionally and structurally independent of the universal core. The universal core includes a leaflet structure 200 that allows blood to flow in one direction. The adapter 300 is used to anchor the artificial heart valve 1000 at the target implantation site.

[0082] The universal core according to the embodiments of the present disclosure can be universally applicable to a variety of application scenarios, which can correspond to different implantation locations (e.g., aortic valve location, pulmonary valve location, mitral valve location, tricuspid valve location), different implantation methods (e.g., surgical operation or transcatheter implantation method) and / or different implantation conditions (e.g., stenosis, incomplete closure, etc.).

[0083] like Figure 2 As shown, the universal core includes a stent 100 and a leaflet structure 200 connected to the stent 100 .

[0084] The stent 100 may be annular, having a distal end 1 and a proximal end 2 opposite to each other in the axial direction, and a mesh structure as a circumferential side wall of the stent 100, the mesh structure being configured to allow the stent 100 to contract or expand in the radial direction. Based on the mesh structure, after the stent 100 is placed at a desired implantation position in the heart, it can be radially expanded from a contracted state to an expanded state.

[0085] In some optional embodiments, the material of the stent 100 may be medical stainless steel, nickel-titanium alloy (Nitinol) or cobalt-chromium alloy, etc.

[0086] In some optional embodiments, in the radial direction, the wall thickness of the stent 100 may be 0.1 mm to 1 mm, for example, 0.2 mm to 0.6 mm.

[0087] In some optional embodiments, the diameter of the bracket 100 can be 5 mm to 55 mm, for example, 10 mm to 30 mm, and the diameter can be the same as or different from the diameter of the adapter 300. For example, depending on the material of the adapter 300, the diameter difference between the bracket 100 and the adapter 300 can be 1 mm to 2 mm.

[0088] The leaflet structure 200 includes a plurality of leaflets 210, each leaflet being at least partially disposed within the stent 100. The leaflet structure 200 is configured to allow blood to flow from the proximal end 2 through the artificial heart valve 1000 to the distal end 1, and to inhibit blood from flowing from the distal end 1 through the artificial heart valve 1000 to the proximal end 2. As an example, Figure 2 As shown, the leaflet structure 200 can be formed by three leaflets 210 connected to each other, and each leaflet 210 is attached to a corresponding position of the stent 100 respectively.

[0089] In some optional embodiments, the material of each leaflet 210 may be bovine pericardium, porcine pericardium or a polymer material. In some optional embodiments, the wall thickness of each leaflet 210 may be 0.1 mm to 0.7 mm, for example, 0.2 mm to 0.45 mm.

[0090] According to various embodiments of the present disclosure, a designated adapter can be selected from a variety of adapters with different configurations (e.g., structures, sizes, and / or materials) as the adapter 300 connected to the universal core. The various adapters 300 are respectively suitable for different application scenarios, for example, they can have various adapter configurations suitable for different implantation locations (aortic valve, pulmonary valve, mitral valve, tricuspid valve, etc.), different implantation methods (e.g., surgery or transcatheter implantation), and different implantation conditions (stenosis, incomplete closure, etc.). Based on this, in actual applications, there is no need to change or replace the universal core (including the stent 100 and the leaflet structure 200), and it is only necessary to select a designated adapter 300 from a variety of adapters according to the desired application scenario to obtain an artificial heart valve 1000 suitable for the desired application scenario.

[0091] That is, by combining the unchanged universal core with different adapters 300, an artificial heart valve 1000 adapted to various application scenarios can be simply obtained. As an example, an adapter 300 adapted to the aortic valve position can be selected from a variety of adapters to be connected to the universal core, thereby obtaining an artificial heart valve suitable for the aortic valve implantation position; as another example, an adapter 300 adapted to transcatheter implantation can be selected from a variety of adapters to be connected to the universal core, thereby obtaining an artificial heart valve that can be implanted to the corresponding target position through transcatheter implantation or similar methods.

[0092] Specifically, a designated adapter 300 adapted to a desired application scenario can be detachably connected to the stent 100 to anchor the stent 100 and the leaflet structure 200 attached to the stent 100 to a target position, thereby allowing the leaflet structure 200 to replace the natural leaflet at the target position.

[0093] In some embodiments, each adapter 300 can be annular and can be connected to the stent 100 through a physical connection scheme supported by a plurality of cantilever stents 10. Each adapter 300 can have a blood inflow end that matches the contour shape of the proximal end 2 of the stent 100 so that the universal core can be adapted to different adapters 300. The physical connection scheme includes, but is not limited to, a connection between a connection line and a hole / slot assembly, an insertion connection between a thread and a slit, and other female / male joints.

[0094] Figure 3 and Figure 4 The schematic diagrams of the structures of two different adapters that can be used for artificial heart valves according to the embodiments of the present disclosure are respectively shown. The adapter includes a top surface and a bottom surface, the top surface has a continuous peak-valley profile, and the continuous peak-valley profile is conformally attached or connected to the stent. In the adapter of the embodiment of the present disclosure, the ratio of the peak height to the valley height is in the range of 20:1 to 1.2:1, wherein the peak height refers to the longest distance from the top surface to the bottom surface in the vertical direction, and the valley height refers to the shortest distance from the top surface to the bottom surface in the vertical direction.

[0095] The bottom surface of the adapter is configured to be fixed to the target location by a plurality of second connection structures, including but not limited to: a uniformly distributed row of openings (eg, holes, slots, slits), connection lines, sutures.

[0096] The height of the bracket 100 refers to the longest distance from the proximal end to the distal end. In the disclosed embodiment, the ratio between the height of the bracket 100 and the peak height of the adapter is 20:1 to 1:1, including 20:1 and 1:1. In one example, the ratio between the height of the bracket 100 and the peak height of the adapter may be 10:1. In another example, the ratio between the height of the bracket 100 and the peak height of the adapter may be 2:1. In yet another example, the ratio between the height of the bracket 100 and the peak height of the adapter may be 1.8:1. In yet another example, the ratio between the height of the bracket 100 and the peak height of the adapter may be 1.5:1. In yet another example, the ratio between the height of the bracket 100 and the peak height of the adapter may be 1.2:1.

[0097] like Figures 2 to 4As shown, the adapter 300 may have a ring-shaped structure or a ring-like structure so that the adapter 300 can be anchored at different implantation locations.

[0098] As an example, Figure 2 and Figure 3 The adapter 300 shown has a rigid or semi-rigid solid structure, so that it can be suitable for implantation based on a conventional surgical procedure. The radial diameter of the adapter 300 is the same as the diameter of the stent 100 in at least one expanded state.

[0099] As another example, Figure 4 The adapter 300 shown has a mesh structure, or includes a hollow structure that can expand or contract in the radial direction, so that it can be suitable for implantation based on expandable surgery, such as valve-in-valve procedure in the future.

[0100] Various adapters 300 can be detachably connected to the stent 100 at the proximal end 2 in various ways (e.g., suturing, hooking, embedding, etc.), so that the adapter 300 of the artificial heart valve 1000 can be conveniently replaced according to the required application scenario without changing the universal core.

[0101] Figure 5 FIG. 1 is a schematic diagram showing the structure of an artificial heart valve according to an embodiment of the present disclosure. Figure 2 compared to, Figure 5 The adapter 300 in is drawn separately from the generic core, and Figure 5 The dotted lines drawn in FIG. 1 are only used to exemplarily illustrate the connection structure (eg, suture or connection line) used to connect the stent 100 and the adapter 300. Further, Figure 6 A schematic structural diagram showing an example of a bracket according to an embodiment of the present disclosure. Figure 7 Show Figure 5 A schematic side view of the bracket is shown.

[0102] As an example, refer to Figures 2 to 6 As shown, the stent 100 includes a mesh structure 110 and a plurality of cantilever struts 10 connected to the mesh structure 110 , and the adapter 300 may be detachably connected to the stent 100 based on the plurality of cantilever struts 10 .

[0103] As an example, the width of each cantilever strut 20 may be 0.1 mm to 1 mm, such as 0.2 mm to 0.7 mm.

[0104] Each cantilever strut 10, for example, extends a certain length from the mesh structure to the proximal end 2, so as to act as a free cantilever without affecting the contraction and expansion of the stent 100. As a cantilever, the fixed end of each cantilever strut 10 is constantly connected to the mesh structure, and the free end of each cantilever strut 10 extends to the proximal end 2. Therefore, in some examples, each cantilever strut 10 can have at least three degrees of freedom of movement, including two degrees of freedom of translational movement and one degree of freedom of rotation. The two degrees of freedom of translational movement are respectively selected from the three degrees of freedom of translational movement along the X, Y and Z axis directions, for example, the degrees of freedom of translational movement in the X and Y axis directions, respectively. The X, Y and Z directions can be defined in a coordinate system with the connection point between the mesh structure and the fixed end of the cantilever strut as the origin. The rotational freedom is, for example, selected from one of two rotational freedoms (spin freedom and revolution freedom), wherein spin is defined as rotation around its own axis, allowing the cantilever strut free end to rotate around itself, and revolution is defined as the free end of the cantilever strut rotating around a non-self axis (e.g., the axis of the cylinder corresponding to the circumferential sidewall of the mesh structure, or the axis or pseudo-axis formed when the free end of the cantilever strut is lifted and rotated around). In another example, each cantilever strut 10 can further translate along another direction, such as along the Z axis. In yet another example, each cantilever strut 10 can also rotate along another axis. For different adapters for various applications, the movement on three or four degrees of freedom allows the stent 100 to be slightly deformed, thereby having a smaller impact on the structure of the artificial heart valve 1000. Since the free end of each cantilever strut 10 is flexible, it is not necessary to redesign the structure of the stent 100 so that the proximal end 2 of the stent 100 can be adaptively connected to the adapter 300 of various sizes and / or shapes.

[0105] As an example, at least one cantilever support rod 10 can be slightly deformed (eg, bent, twisted and / or tilted with the fixed end as a fulcrum) so that the free end of each cantilever support rod 10 can be adjusted from its initial position to a position adapted to the corresponding adapter 300 .

[0106] As an example, the mesh structure 110 and each cantilever support rod 10 can be integrally formed of the same material. The material can have sufficient toughness to allow the mesh structure to contract and expand, and allow the free end of each cantilever support rod to have at least three degrees of freedom of movement, such as translational freedom along the X, Y and Z axes.

[0107] As an example, at least one cantilever support rod 10 is provided with an opening 11 for allowing various adapters 300 to be connected to the support 100. For example, Figures 2 to 6 As shown, the opening may be realized as a hole provided at the proximal end 2 of the stent 100. As an optional embodiment, as Figure 5As shown, the adapter 300 may be provided with an opening 311 corresponding to the opening 11 on the cantilever strut 10, so that the cantilever strut 10 can be detachably connected to the adapter 300 based on the openings 11 and 311. For example, the first connection structure 82 (e.g., sutures, connecting lines or other physical connection structures) can be used to connect the bracket 100 to the designated adapter 300 through the opening 11 on the cantilever strut 10 and the opening 311 on the adapter 300. The opening 311 may include at least two rows of openings, a row of openings 311 located at the top and a row of openings 311 located at the bottom, wherein the row of openings 311 located at the top is arranged along the top surface of the adapter 300. The openings 311 located in the top row and the openings of the cantilever strut can be paired to allow the connection between the two to be achieved through a connecting line or a suture, so that the universal core is connected to the adapter. In one example, there are, for example, three groups of openings on the cantilever strut, and they are roughly aligned in the vertical direction with the openings in the first row on the adapter to be paired.

[0108] The first connection structure 82 (e.g., sutures, connection lines or other physical connection structures) is mainly used to support each leaflet and helps to increase the life of the artificial heart valve. Since multiple cantilever struts 10 are softly connected by the first connection structure 82 to form a support structure for the leaflet structure, the first connection structure 82 can pass through the cantilever struts, and is not too tight to prevent each cantilever strut from being deformed due to the first connection structure 82 being too tight, or is not too loose to prevent it from failing to provide sufficient support for the leaflet structure. In addition, the first connection structure 82 does not fix or fasten each cantilever strut at a corresponding position, that is, the first connection structure 82 does not tightly sew each cantilever strut, so that these cantilever struts can still move relative to blood pressure in at least three degrees of freedom. At the same time, the covering layer (one or more) according to the embodiment of the present disclosure may also have sufficient freedom of movement.

[0109] In some optional embodiments, the connection line used as the first connection structure 82 may have a thickness of 0.3 mm to 0.7 mm.

[0110] For the purpose of structural integrity, the density of the openings in the top row and the openings in the bottom row can be the same or different. The openings in the bottom row can be configured to secure the adapter in a target position. In one example, the number of openings 311 in the top row of the adapter is greater than the number of openings 11 in the bracket 100. In another example, the number of openings 311 in the top row of the adapter is less than the number of openings 11 in the bracket 10. In one example, the top row can be provided with 10 openings. In another example, the top row can be provided with 20 openings.

[0111] In some embodiments, Figure 5As shown, a first connecting structure 82 (e.g., a suture or a connecting line) can pass through the opening 11 on each cantilever strut 10 to form a support structure for supporting the leaflet structure 200, so that each leaflet 210 of the leaflet structure 200 can be attached to the stent 100 at least based on the corresponding cantilever strut 10.

[0112] In some embodiments, a first connection structure 82 (eg, sutures or connecting wires) may be inserted into the opening 11 on each cantilever strut 10 to form a support structure.

[0113] For example, in some embodiments, each leaflet 210 may have an arc-shaped restraining edge for fixing to the stent 100 (e.g., Fig. 9 The edge 27 or Fig.21 edge 25 as shown), and a free edge disposed within the bracket (e.g., as Fig.10 The free edge of each leaflet 210 allows blood to flow out from the proximal end 2 to the distal end 1 through the artificial heart valve when separated from the other leaflets in the open position, and inhibits blood from flowing out from the distal end 1 to the proximal end 2 through the artificial heart valve when in contact with the other leaflets in the closed position. Based on the first connection structure 82 (e.g., sutures or connecting lines) and a plurality of cantilever struts 10, at least a portion of the arcuate constraint edge can be folded from the inside of the stent 100 to the outer peripheral surface of the stent 100 so that the arcuate constraint edge wraps the first connection structure 82 (e.g., sutures or connecting lines) and the proximal end of the stent 100.

[0114] It should be noted that the opening (cavity) described in the present disclosure is not limited to Figures 2 to 6 The circular hole shown can also be designed as a rectangle, oval, polygon, irregular shape or other shapes. In some optional embodiments, the opening can also be realized by a slit or groove of various shapes. In some preferred embodiments, the slit as the opening can be easily inserted or penetrated.

[0115] The mesh structure of the stent 100, for example, includes a plurality of first grid units 110a and a plurality of second grid units 110b distributed along the circumferential direction of the stent 100, and the plurality of second grid units 110b respectively correspond to the positions of the commissures 20 formed by adjacent leaflets 210 in the leaflet structure 200, so that the commissures 20 of adjacent leaflets 210 can be fixed to the stent 100 based on the second grid units 110b. The number of the second grid units 110b may be greater than / equal to the number of leaflets 210 in the leaflet structure 200.

[0116] In some embodiments, Figure 6As shown, each first grid unit 110a and each second grid unit 110b may be respectively annular, and each first grid unit 110a and each second grid unit 110b are sequentially arranged along the circumferential direction of the stent 100 to form the side wall of the stent 100. For example, in order to facilitate contraction and expansion, the annular shape presented by each first grid unit 110a is, for example, approximately a shuttle shape with two ends pointing to the proximal end and the distal end, respectively.

[0117] As an example, Figure 7 As shown, each second grid unit 110b has a first node A and a second node A' at the proximal end 2, and the first node A and the second node A' are connection points between the second grid unit 110b and the first grid units 110a adjacent to its two sides, respectively.

[0118] In some embodiments, Figure 7 As shown, two adjacent first mesh units 110a may have a common edge 32, and each second mesh unit 110b and the adjacent first mesh unit 110a may have a common edge 31 (including the first node A or the second node A').

[0119] As an example, Figure 6 and Figure 7 As shown, each cantilever strut 10 can extend along the axial direction of the stent 100 between one end (close to the proximal end 2 ) of the corresponding first grid unit 110 a and the proximal end 2 of the stent 100 , so as not to affect the contraction and expansion of the stent 100 .

[0120] In some embodiments, every two adjacent second grid units 110b are separated by at least one first grid unit 110a. Figure 6 As shown, a fixed number of first grid units 110a may be spaced between every two adjacent second grid units 110b. As another example, an odd number of first grid units 110a may be spaced between every two adjacent second grid units 110b, and / or, the length of the cantilever strut 10 of the first grid unit 110a located between two adjacent second grid units 110b may decrease from the middle to both sides in the circumferential direction of the stent 100, so that the position of the free end of each cantilever strut 10 can be adapted to the position of the lower edge 22 of the corresponding leaflet 210 at the proximal end 2, which is beneficial for the cantilever strut 10 to provide support for each leaflet 210.

[0121] In some embodiments, Figure 6 and Figure 7As shown, at least one second grid unit 110b may be provided with a connection opening 30 (e.g., a hole, a slit, or a groove) at the distal end 1 for detachably connecting to a delivery device of an artificial heart valve (e.g., by means of sutures or connecting lines). Each connection opening 30 is not limited to the shape shown in the figure, and may also be designed to be circular, square, elliptical, polygonal, irregular, etc.

[0122] Figure 8a A partial structural schematic diagram showing a first exemplary structure of a bracket according to an embodiment of the present disclosure.

[0123] like Figure 8a As shown, each second grid unit 110b includes a first edge 40 extending from the first node A to the interior of the second grid unit 110b and a second edge 40' extending from the second node A' to the interior of the second grid unit 110b, and the first edge 40 and the second edge 40' are connected at the intersection 42 inside the second grid unit 110b. The contour 3 defined by each first edge 40, each second edge 40', and the free end of each cantilever strut 10 of the stent 100 can match the proximal end contour of the leaflet structure 200, so that each leaflet 210 can be fixed to the stent 100 based on each first edge 40, each second edge 40' and each cantilever strut 10.

[0124] As an example, the profile 3 of the stent 100 at the proximal end 2 is an arcuate profile that matches the lower profile formed by the lower edges 22 of the plurality of leaflets 210 .

[0125] As an example, the intersection 42 may be in an arc shape, a sharp angle shape, or other shapes, and the present disclosure does not limit the specific shape of the intersection.

[0126] Figure 8b A partial structural schematic diagram showing a second exemplary structure of the bracket according to an embodiment of the present disclosure.

[0127] Figure 8b The second grid unit 110b shown is different from Figure 7 and 8a The second grid unit 110b shown in FIG. 1 is different in that: Figure 8b In the second grid unit 110b shown, an opening 11' may also be provided at the intersection 42 of the first edge 40 and the second edge 40', and the opening 11' can be used to connect with the opening 11, and the opening 11 is fixed to the first grid unit 110a by sutures or connecting lines, thereby providing further support for the leaflet structure 200 at the proximal end 2.

[0128] Figure 8c A partial structural schematic diagram showing a third exemplary structure of a bracket according to an embodiment of the present disclosure.

[0129] In some optional embodiments, Figure 8cThe second grid unit 110b shown in FIG. 1 is different from Figure 7 and 8a The second grid unit 110b shown in FIG. 1 is different in that: Figure 8c In the second grid unit 110 b shown, the first side 40 and the second side 40 ′ may extend in a rod-like shape from the intersection 42 to the top (located at the distal end 1 ) of the second grid unit 110 b , thereby providing further support for the leaflet structure 200 at the distal end 1 .

[0130] It should be noted that the bracket 100 according to the embodiment of the present disclosure may include the bracket 100 based on the above embodiment (refer to Figures 8a to 8c ) provides one or more exemplary structures of a second grid unit.

[0131] Fig. 9 A schematic diagram showing a leaflet structure according to an embodiment of the present disclosure. Fig.10 A schematic diagram of the flattened structure of a single leaflet according to an embodiment of the present disclosure is shown. Fig.11 A schematic diagram showing an exemplary structure of a universal core according to an embodiment of the present disclosure is shown.

[0132] like Fig. 9 and Fig.11 As shown, the leaflet structure 200 includes a plurality of leaflets 210 to allow blood to flow from the proximal end 2 to the distal end 1 through the artificial heart valve 1000 and to inhibit blood from flowing from the distal end 1 to the proximal end 2 through the artificial heart valve 1000. The leaflet structure 200 is independent of the adapter 300 as part of the universal core.

[0133] As a typical example, Fig. 9 and Fig.11 As shown, the leaflet structure 200 includes three angled and interconnected leaflets 210 , and the present disclosure is mainly explained based on this example. However, the present disclosure does not limit the number of leaflets 210 in the leaflet structure 200 , and the leaflet structure 200 may also be composed of two or more leaflets 210 .

[0134] like Fig.10 As shown, the flattened shape of a single leaflet 210 is, for example, a semicircle or a semicircle-like shape. Each leaflet 210 has two side edges 21 opposite to each other at the distal end 1, an upper edge 23 (free edge) extending between the two side edges 21, and a lower edge 22 at the proximal end 2, wherein each side edge 21 is fixed to the side edge 21 of another adjacent leaflet 210 to form a joint 20, so that adjacent leaflets 210 can be connected to each other at the joint 20, as shown in FIG. Fig.11 The commissures 20 formed by the plurality of leaflets 210 are attached to the top of the stent 100. As an example, the commissures 20 formed by the plurality of leaflets 210 may be attached to the corresponding second mesh units 110b, respectively.

[0135] At least a portion of each leaflet 210 is disposed within the stent 100, for example, Fig.11 As shown, each joint 20 can be located inside the stent 100 and attached to the inner side of the corresponding second grid unit 110 b , and the side edges 21 and upper edges 23 of the plurality of leaflets 210 are disposed in the internal space surrounded by the stent 100 .

[0136] The lower edge 22 of each leaflet 210 can be attached to the proximal end 2 of the stent 100, e.g. Fig.12 As shown, the lower edge 22 may be attached to and supported by the cantilevered strut 10 of the bracket 100 . Fig.12 The figure shows the lower edge 22 of one leaflet 210. In view of this, although the lower edges of the other leaflets 210 are not shown in the figure, it should be understood that the lower edges of the other leaflets 210 may also have the same Fig.12 The lower edge 22 shown is of the same construction.

[0137] As an example, Fig.11 As shown, based on one or more cantilever struts 10, the lower edge 22 of each leaflet 210 can be folded from the internal space surrounded by the stent 100 to the outside of the stent 100, so that the lower edge 22 of the leaflet can be attached to the cantilever strut 10 (for example, sutured through the opening 11, the opening 11 is, for example, a hole, a groove, or a slit).

[0138] Any structure based on a scaffold (ref. Figures 8a to 8c In an exemplary stent structure), for each leaflet 210, a gap 24 is provided between the lower edge 22 and each side edge 21, and the gap 24 can correspond in position to the joint 42 so as to allow the lower edge 22 of the leaflet 210 to be folded from the inside to the outside of the stent 100 based on the curved contour at the proximal end 2 of the stent 100 (defined by the cantilever strut 10, the first side 40 and the second side 40' of the corresponding second grid unit 110b), while allowing each side edge 21 to be attached to the opposite side (i.e., the inside) of the stent 100.

[0139] In addition, the folded lower edges 22 of the plurality of leaflets 210 may also be attached to a corresponding portion of the stent 100 at the proximal end 2 , the corresponding portion of the stent 100 including, for example, one or more cantilever struts 10 of the stent 100 .

[0140] In order to stably secure the leaflet structure 200 to the stent 100, one or more covering layers may be used.

[0141] Fig.12 Shown at Fig.11 A schematic diagram of the cross-sectional structure of a portion of the universal core at a joint position along the radial direction of the stent is shown. Fig.13A schematic diagram showing the positional relationship between the first covering layer and the bracket according to an embodiment of the present disclosure is shown. Fig.14 for Fig.13 A schematic structural diagram of the first covering layer is shown.

[0142] In some optional embodiments, the first covering layer 50 may be provided as a base for suturing so as to fix the leaflet 210 to the stent 100. The first covering layer 50 may cover at least a portion of the inner side of the stent 100, for example, completely or partially covering the plurality of second grid units 110b, each first grid unit 110a adjacent to any second grid unit, and the plurality of cantilever struts 10.

[0143] In some optional embodiments, such as Fig.11 and Fig.13 As shown, at least one of the plurality of first grid units 110a is partially exposed by the first cover layer 50 to improve the hemodynamic characteristics. In some other embodiments, each of the first grid units may be exposed by the first cover layer 50.

[0144] In some optional embodiments, such as Fig.12 and 13 As shown, the first covering layer 50 may include a first portion 51, which is at least partially clamped between a plurality of leaflets 210 and a plurality of second mesh units 110b, so that the joints 20 and / or side edges 21 of the plurality of leaflets 210 can be fixed to each second mesh unit 110b by adopting blanket stitching, locking stitching and / or other types of stitching methods through the first portion 51 of the first covering layer 50.

[0145] In some optional embodiments, the first covering layer 50 may also include a second portion 52, which matches the lower edge 22 of each leaflet 210 in position and shape, so that the lower edges 22 of multiple leaflets 210 can be fixed to the corresponding parts of the stent 100 by blanket sutures, lock stitches and / or other types of sutures through the second portion 52 of the first covering layer 50.

[0146] As an example, the edge of the first cover layer 50 at the distal end may have a profile that matches several frames of the mesh structure. Fig.13 As shown, the several frames may include: a distal border 9a of one or more grid units, wherein the one or more grid units include each second grid unit and each first grid unit adjacent to any second grid unit; a proximal border 9b of one or more first grid units that are not adjacent to each second grid unit; and a rod-shaped border 9c of one or more first grid units adjacent to any second grid unit, wherein the rod-shaped border 9c is shared by two adjacent first grid units.

[0147] In some optional embodiments, the first covering layer 50 may at least completely cover the plurality of second grid units, each first grid unit adjacent to any second grid unit, and the plurality of cantilevered support rods 10 .

[0148] Fig.15 is a schematic diagram of the positional relationship between the second covering layer and the bracket according to an embodiment of the present disclosure, Fig.16 for Fig.15 The schematic diagram of the structure of the second covering layer shown in FIG. Fig.17 It is a schematic structural diagram of a bracket having a first covering layer and a second covering layer according to an embodiment of the present disclosure.

[0149] In some optional embodiments, in order to fix the leaflet 210 to the stent 100, a second cover layer 60 may also be provided as a base for suturing.

[0150] The second cover layer 60 may have a skirt-like shape, such as Figures 15 to 17 The second covering layer 60 may cover at least a portion of the outer side surface of the stent 100 , for example, completely or partially covering the plurality of second grid units 110 b and the plurality of cantilever struts 10 .

[0151] In some optional embodiments, such as Fig.15 and Fig.17 As shown, at least one of the plurality of first grid units 110a is partially exposed by the second cover layer 60 to ensure hemodynamic properties. In some other embodiments, each of the first grid units may be exposed by the first cover layer 50.

[0152] In some optional embodiments, such as Fig.15 and Fig.17 As shown, the second covering layer 60 may include a first part 61, which is fixedly connected to at least each second grid unit 110b, the first part of the first covering layer and / or the side edge 21 of each leaflet 210 by adopting blanket stitching, lock stitching and / or other types of stitching methods through the first part 61 of the second covering layer 60.

[0153] In some optional embodiments, the second covering layer 60 may also include a second portion 62 having a proximal profile that matches the lower edge 22 of the multiple leaflets 210 in position and shape, so that the lower edge 22 of the multiple leaflets 210 can be fixed to the corresponding portion of the stent 100 by adopting blanket sutures, lock-stitching and / or other types of sutures through the second portion 62 of the second covering layer 60. For example, the second portion 62 of the second covering layer 60 can be sutured together with the corresponding portion of the stent 100 and the second portion 52 of the first covering layer 50.

[0154] In some optional embodiments, the edge of the second cover layer 60 at the distal end may have a contour that matches the distal border 9d of one or more second grid cells.

[0155] In some optional embodiments, the first covering layer 50 and the second covering layer 60 can be integrated into a single covering layer, which can wrap the proximal end of the stent 100 based on the first connecting structure 82 and the plurality of cantilever struts 10, and can be at least partially sandwiched between the stent 100 and the plurality of leaflets 210 at the proximal end. Alternatively, in some other embodiments, the first covering layer 50 and the second covering layer 60 can be independent covering layers having the above-mentioned structural features.

[0156] In some optional embodiments, the material of the first cover layer 50 and / or the second cover layer 60 may be PET or other materials that promote endothelialization. In some optional embodiments, the thickness of the first cover layer 50 and / or the second cover layer 60 may be 0.05 mm to 0.5 mm, for example, 0.1 mm to 0.25 mm.

[0157] It should be understood that the height of the second covering layer 60 can be changed based on design requirements. For example, the height of the second covering layer 60 can be similar to the length of a selected cantilever support rod from the plurality of cantilever support rods 10, or the maximum / average length of the plurality of cantilever support rods 10; or, the second covering layer 60 can also have a height that matches the shape of the first covering layer 50.

[0158] Fig.18a for Fig.17 An exemplary cross-sectional schematic diagram of the universal core along line QQ' is shown, Fig.18b for Fig.17 Another exemplary cross-sectional schematic diagram of the universal core along line QQ' is shown.

[0159] In an optional example, if Fig.18a As shown, the second portion 62 of the second covering layer 60 is at least partially sandwiched between the corresponding portion of the bracket 100 and the lower edges 22 folded to the outside of the bracket 100 based on the first connecting structure 82 and the plurality of cantilever struts 10 .

[0160] In another alternative example, if Fig.18b As shown, the lower edges 22 of the first connection structure 82 and the plurality of cantilever struts 10 folded to the outside of the bracket 100 may be at least partially sandwiched between the second portion 62 of the second cover layer 60 and a corresponding portion of the bracket 100 .

[0161] In some embodiments, Fig.18a and 18bTaking the example shown as an example, at least a portion of the arc-shaped constraint edge of each leaflet (i.e., the portion folded from the inside of the stent 100 to the outer peripheral surface of the stent 100 based on the first connection structure 82 and the plurality of cantilever struts 10) can be sutured for a distance (e.g., 5 mm) from the edge of the stent 100 at the proximal end 2 to a corresponding position on the outer peripheral surface of the stent 100. In some optional embodiments, since the folded portion of each leaflet 210 is mainly used to support the leaflet and improve the life of the artificial heart, the suture point of each leaflet can be sutured from the edge of the stent 100 at the proximal end 2 to the end of the arc-shaped constraint edge of the leaflet being folded to the outer peripheral surface of the stent 100.

[0162] Fig.19 A partial structural schematic diagram showing a third exemplary structure of the bracket according to an embodiment of the present disclosure, Fig. 20 for Fig.19 The schematic diagram of the structure of the support with the third covering layer is shown in FIG. Fig.21 for Fig. 20 An exemplary cross-sectional schematic diagram of the universal core along line YY' is shown, Fig. 22 A schematic diagram showing a flattened structure of a single leaflet according to an embodiment of the present disclosure is shown.

[0163] like Fig.19 As shown, in each second grid unit 110b of the stent 100, the first side 40 and the second side 40' extend along the lower contour of the stent 100 to a position in contact with the top of the second grid unit 110b at the distal end. As an optional example, the contact point between the first side 40 and the top of the second grid unit 110b may coincide with or separate from the contact point between the second side 40' and the top of the second grid unit 110b, so that the continuous arc-shaped edge 25 (see FIG. 25 ) for receiving the corresponding leaflet 210 is not necessarily connected to the second side 40. Fig. 22 ) can be defined by the first edge and the second edge, so each leaflet can have a continuous arcuate edge 25, which can be formed without forming, for example, Fig.10 In the case of the slit shown, the slit is folded from the inner space of the stent 100 to the outside of the stent 100 , thereby improving the durability and material stability of the leaflet structure 200 .

[0164] Specifically, Fig. 22 As shown, the continuous arcuate edge 25 of each leaflet 210 is composed of the side edge 21 and the lower edge 22 of the leaflet 210 (see Fig.10 ) is formed, and is folded to the outside of the stent 100 based on the first connecting structure 82, a plurality of cantilever struts 10, a first edge 40 of a second grid unit 110b adjacent thereto, and a second edge 40' of another second grid unit 110b adjacent thereto. The continuous arc-shaped edge 25 of each leaflet is attached to at least the corresponding portion of the stent 100 at the proximal end 2.

[0165] Based on Fig.19 In the exemplary structure of the stent shown, the first covering layer and the second covering layer, which are independently arranged, can be replaced by a third covering layer 70 (as a single-piece covering layer including the first covering layer and the second covering layer), and the third covering layer 70 can be used as a base for suturing to fix the leaflet 210 to the stent 100.

[0166] like Fig. 20 As shown, the third covering layer can be folded from the inside of the stent 100 to the outside of the stent 100 based on the first connecting structure 82 and the multiple cantilever struts 10, and at least covers the first side 40 and the second side 40' of each second grid unit 110b and the free ends of the multiple cantilever struts 10 at the proximal end 2.

[0167] In addition, if Fig.21 As shown, the continuous arcuate edge 25 of each leaflet 210 can be fixed to the third covering layer 70 by using blanket suture, lock stitch and / or other types of suture through the third covering layer, so that the continuous arcuate edge 25 can be attached to the corresponding part of the stent 100 at the distal end 1 and / or the proximal end 2. The third covering layer 70 can be at least partially sandwiched between the continuous arcuate edge 25 and the corresponding part of the stent 100 at the proximal end 2.

[0168] In some embodiments, Fig.21 For example, at least a portion of the continuous arcuate edge 25 of each leaflet (i.e., the portion that is folded outward from the inside of the stent 100 to the outer peripheral surface of the stent 100 based on the first connecting structure 82 and multiple cantilever struts 10) can be sutured a distance (for example, 5 mm) from the edge of the stent 100 at the proximal end 2 to a corresponding position on the outer peripheral surface of the stent 100. In some optional embodiments, since the folded portion of each leaflet 210 is mainly used to support the leaflet and increase the life of the artificial heart, the suture point of each leaflet can be sutured from the edge of the stent 100 at the proximal end 2 to the end where the arcuate constraint edge of the leaflet is folded to the outer peripheral surface of the stent 100.

[0169] In some optional embodiments, the material of the third covering layer 70 may be PET or other materials that promote endothelialization. In some optional embodiments, the thickness of the third covering layer 70 may be 0.05 mm to 0.5 mm, such as 0.1 mm to 0.25 mm.

[0170] Fig.23 A schematic structural diagram of an artificial heart valve with a sewing ring according to an embodiment of the present disclosure is shown.

[0171] According to any embodiment of the present invention, Fig.23As shown, a sewing ring 500 may be further provided. The sewing ring 500 is configured to match with a designated adapter 300 and can be attached to the outer surface of the designated adapter 300 and the target implantation site.

[0172] In some optional embodiments, the material of the sewing ring 500 may be PET, PTFE, or the like.

[0173] Fig.24 A schematic diagram showing the structure of an artificial heart valve according to an embodiment of the present disclosure when the leaflets are in an open state; Fig.25 A schematic side view of an artificial heart valve according to an embodiment of the present disclosure when the valve leaflets are in an open state is shown, Fig.26 for Fig.25 The illustrated schematic cross-sectional view of the artificial heart valve along line SS' when the valve leaflets are in an open state.

[0174] See also Figures 24 to 26 As shown, it should be noted that the leaflet 210 is configured to move between an open position and a closed position, wherein the leaflet 210 allows blood to flow from the proximal end 2 through the artificial heart valve 1000 to the distal end 1 in the open position, and inhibits blood from flowing from the distal end 1 through the artificial heart valve 1000 to the proximal end 2 in the closed position.

[0175] In some embodiments, the artificial heart valve further includes a base cover layer 310 that surrounds the inner and / or outer peripheral surfaces of the adapter 300 to prevent blood from flowing in directions other than the direction between the proximal and distal openings of the adapter.

[0176] In some embodiments, the base cover layer 310 may be stitched to one or both of the first cover layer 50 and the second cover layer 60 .

[0177] In some optional embodiments, the material of the base cover layer 310 may be a polymer material, such as PET, to promote endothelialization.

[0178] In some optional embodiments, the thickness of the base cover layer 310 may be 0.05 mm to 0.5 mm, for example, 0.1 mm to 0.25 mm.

[0179] According to various embodiments of the present disclosure, a method for assembling an artificial heart valve is provided, which mainly comprises the following steps:

[0180] Use connecting wires to softly connect multiple cantilever support rods;

[0181] Based on the connecting line and the plurality of cantilever struts, each of the leaflets is connected to the stent by suturing; and

[0182] A designated adapter is selected and connected to the plurality of cantilever struts by suturing.

[0183] The steps included in the method for assembling an artificial heart valve can be known based on the description of the above embodiments, and will not be repeated here.

[0184] According to the artificial heart valve and its assembly method provided by each embodiment of the present disclosure, it is mainly composed of a universal core and an adapter that are independent of each other in structure and function to form a two-piece structure in the true sense, and the cantilever strut of the universal core is used to be detachably connected to the adapter. The universal core includes a leaflet structure and an annular stent with a cantilever strut and a mesh structure, and is generally applicable to various application scenarios, for example, in independent surgical operations or implantation of transcatheter clamp-type valve delivery. The stent with a mesh structure provides stability for the artificial heart valve, and the leaflet is connected to the cantilever strut and / or the distal part of the stent. According to the specified application scenario, the adapter can be selected from a variety of adapters, which are respectively applicable to various application scenarios and are respectively configured to anchor the universal core at the corresponding implantation position. Each cantilever strut can be a free cantilever, which is configured to allow movement in at least three degrees of freedom, and can be slightly deformed facing various adapters in various application scenarios, and the valve structure is less affected. Therefore, the artificial heart valve provided according to the various embodiments of the present disclosure has good versatility and flexibility, can significantly save time and R&D costs, improve the utilization efficiency of the production line, and accelerate the clinical application and marketization process of artificial heart valves.

[0185] In addition, multiple cantilever struts can be flexibly connected through connecting lines to form a support structure for the leaflet structure, which helps to increase the life of the artificial heart valve.

[0186] In some optional embodiments, each cantilever strut may be provided with an opening through which a connecting structure (e.g., a suture or a connecting line) may pass to form a support structure for supporting the leaflet structure, so that each leaflet may be attached to the stent at the proximal end based on the cantilever strut. These openings may also be used to connect to a designated adapter.

[0187] In some optional embodiments, each second grid unit may be provided with a cantilevered strut / opening to further provide stable support for the commissures and / or edges of the leaflets.

[0188] In some optional embodiments, each second grid unit may be provided with a gap for accommodating a corresponding leaflet, so that each leaflet may have a continuous arcuate edge which may be folded from the internal space of the stent to the outside of the stent without forming a gap, thereby improving the durability and material stability of the leaflet structure.

[0189] In view of the fact that the principles of the present invention can be applied to many possible embodiments, it should be recognized that the embodiments presented herein are only preferred examples of the present invention and should not be considered as limiting the scope of the present invention. On the contrary, the scope of the present invention is limited by the appended claims, and all rights within the scope and spirit of these claims and their equivalents are included within the scope of this disclosure.

Claims

1. An artificial heart valve, comprising: Universal core, suitable for different application scenarios, including: An annular stent having a distal end and a proximal end in an axial direction, the stent comprising a mesh structure as a circumferential side wall, allowing the stent to contract or expand in a radial direction, the stent being configured to allow blood to flow from the proximal end to the distal end, the stent further comprising a plurality of cantilever struts of different lengths, each of the cantilever struts extending from the proximal end to the distal end of the mesh structure and being configured to allow movement in at least three degrees of freedom; A leaflet structure, comprising a plurality of leaflets, each of which is attached to the support and at least partially disposed within the support, the leaflet structure being configured to allow blood to flow from the proximal end to the distal end through the artificial heart valve and inhibit blood from flowing from the distal end to the proximal end; The designated adapter is selected from a variety of adapters suitable for different application scenarios, and the designated adapter is used to anchor the bracket at a target position. The bracket allows for detachable connection with any one of the multiple adapters based on the multiple cantilever struts.

2. The artificial heart valve according to claim 1, wherein: The mesh structure comprises: A plurality of first grid units and a plurality of second grid units are arranged in a circumferential direction, The plurality of leaflets are respectively attached to a corresponding one of the second grid units or a corresponding one of the cantilever struts and are independent of the adapter.

3. The artificial heart valve according to claim 2, wherein: Each of the leaflets has an upper edge, a lower edge at a proximal end, and two opposite side edges, each of the side edges being fixed to the side edge of another adjacent leaflet to form a commissure, the upper edge extending between the two side edges, The proximal end of the stent matches the lower contour formed by the lower edges of the plurality of leaflets.

4. The artificial heart valve according to claim 3, wherein: Each of the second grid cells comprises: A first node connected to the adjacent first grid unit; a second node connected to another adjacent first grid unit; A first edge extending from the first node to the interior of the second grid cell; and A second edge extending from the second node to the interior of the second grid unit, Wherein, each of the side edges of a corresponding one of the leaflets is attached to the support based on the first edge and / or the second edge.

5. The artificial heart valve according to claim 4, wherein: In each of the second grid cells, The first edge and the second edge extend along the lower contour to contact the top of the second grid unit at the distal end, and the contact point between the first edge and the top coincides with or is separated from the contact point between the second edge and the top, thereby defining a gap based on the first edge and the second edge, and the gap is used to receive the continuous arc-shaped edge of the corresponding leaflet. The continuous arcuate edge is formed by the side edges and the lower edge of the corresponding leaflet, and based on the multiple cantilever struts, the first side of the adjacent second grid unit, and the second side of another adjacent second grid unit are folded to the outside of the stent, and the continuous arcuate edge is at least attached to the corresponding part of the stent at the proximal end.

6. The artificial heart valve according to claim 1, wherein: Each of the adapters is annular and is connected to the bracket via a physical connection supported by the plurality of cantilever struts.

7. The artificial heart valve according to claim 1, wherein: Each of the cantilever struts is provided with an opening at the proximal end, The openings of the plurality of cantilever struts are connected by sutures or connecting lines to form a support structure, and the plurality of leaflets are attached to the support structure; and / or Each of the adapters is connected to the bracket through the openings of the plurality of cantilever struts.

8. The artificial heart valve according to claim 7, wherein: In each of the second grid cells, The first side and the second side extend along the lower edges of the plurality of leaflets and are connected at an intersection inside the second grid unit. The intersection is connected to at least one of the openings of the plurality of cantilever struts via a suture or a connecting line, and / or the first side and the second side extend in a rod shape from the intersection to the top of the second grid unit at the distal end, In each of the leaflets, gaps are formed between the lower edge and the two opposite side edges, and the gaps correspond to the positions of the intersections, so as to allow the lower edge of the leaflet to be folded to the outside of the support based on the multiple cantilever struts, the first side and the second side of the corresponding second grid unit, and attached to the corresponding parts of the support.

9. The artificial heart valve according to claim 8, further comprising a first covering layer, covering at least a portion of the inner side of the stent and having a skirt-like shape, wherein the first covering layer comprises: A first portion is sutured to each of the side edges of the plurality of second mesh units and the plurality of leaflets, and is at least partially sandwiched between the plurality of leaflets and the plurality of second mesh units; and / or The second portion matches the lower edges of the plurality of leaflets in position and shape, and is sutured with the corresponding portion of the stent and the lower edges of the plurality of leaflets.

10. The artificial heart valve according to claim 9, wherein: The first covering layer at least covers the plurality of second grid units, each of the first grid units adjacent to any of the second grid units, and the plurality of cantilevered support rods, and / or At least one of the first grid cells is partially exposed by the first cover layer.

11. The artificial heart valve according to claim 8, further comprising a second covering layer, the second covering layer covering the outer side of the stent and having a skirt shape, the second covering layer comprising: A first portion, sewn to the plurality of second mesh units and the side edges of the plurality of leaflets; and / or The second part matches the lower edges of the plurality of leaflets in position and shape and is sutured with the corresponding part of the stent and the lower edges of the plurality of leaflets. The second portion of the second covering layer is at least partially sandwiched between the corresponding portion of the bracket and the lower edge folded to the outside of the bracket, or the lower edge folded to the outside of the bracket is at least partially sandwiched between the second portion of the second covering layer and the corresponding portion of the bracket.

12. The artificial heart valve according to claim 5, further comprising a third covering layer, wherein the third covering layer is folded from the inner side of the stent to the outer side and covers at least the first side and the second side of the plurality of second grid units and the terminals of the plurality of cantilever struts at the proximal ends. The continuous arcuate edge of each leaflet is sutured to the third covering layer, the corresponding portion of the stent, and the corresponding second mesh unit, and the third covering layer is at least partially sandwiched between the continuous arcuate edge and the corresponding portion of the stent.

13. The artificial heart valve according to claim 2, wherein At least one of the second grid units is provided with a connection opening at a distal end, and the connection opening is connected to a delivery device of the artificial heart valve.

14. The prosthetic heart valve according to claim 1, further comprising a sewing ring, which matches the designated adapter and can be attached to the outer surface of the designated adapter and the target location.

15. The artificial heart valve according to claim 2, wherein: Adjacent first grid units have a common edge and are connected at the common edge, and / or, The second grid unit and the first grid unit adjacent thereto have a common edge and are connected at the common edge.

16. The artificial heart valve according to claim 1, wherein: Each of the adapters has a blood inflow end that matches the contour shape of the stent at the distal end, and the multiple adapters include: Rigid structural adapters for classical surgical implantation; and Mesh adapter for expandable surgical implantation for valve-in-valve surgery.

17. The artificial heart valve according to claim 1, wherein: The multiple adapters suitable for different application scenarios include various adapters designed for different implantation methods, different implantation conditions and / or different target positions. The implantation methods include surgical implantation and transcatheter implantation. The implantation conditions include stenosis and insufficiency. The target positions include aortic valve position, pulmonary valve position, mitral valve position and tricuspid valve position.

18. The artificial heart valve according to claim 7, wherein: The opening is selected from the group consisting of a hole, a slot and a slit.

19. The artificial heart valve according to claim 18, wherein: At least three openings of the plurality of cantilever struts are configured to mate with the openings of the designated adapter to form pairs to connect the universal core and the designated adapter.

20. An artificial heart valve, comprising: The universal core is suitable for different application scenarios, including: an annular stent having a distal end and a proximal end in the axial direction, the stent comprising: a mesh structure as a circumferential side wall, allowing the stent to contract or expand in the radial direction, the stent being configured to allow blood to flow from the proximal end to the distal end; and a plurality of cantilever struts of different lengths, each of the cantilever struts extending from the proximal end to the distal end of the mesh structure; A leaflet structure, comprising a plurality of leaflets, each of which is attached to the stent and at least partially disposed within the stent, the leaflet structure being configured to allow blood to flow from the proximal end to the distal end through the artificial heart valve and inhibit blood from flowing from the distal end to the proximal end; A designated adapter is selected from a plurality of adapters suitable for different application scenarios, and is used to anchor the bracket at a target location, wherein the bracket and any of the adapters are detachably connected based on the plurality of cantilever struts, The plurality of cantilever struts are flexibly connected via connecting lines to form a support structure for the leaflet structure, and each of the cantilever struts is configured to allow movement in at least three degrees of freedom.

21. The artificial heart valve according to claim 20, wherein: Each of the leaflets has an arc-shaped constraint edge for fixing to the support, and a free edge arranged in the support, wherein the free edge allows blood to flow from the proximal end to the distal end through the artificial heart valve when separated from the other leaflets, and inhibits blood from flowing from the distal end to the proximal end through the artificial heart valve when in contact with the other leaflets. At least a portion of the arc-shaped constraining edge is folded from the inside of the stent to the outer peripheral surface of the stent based on the connecting line and the plurality of cantilever struts, so that the arc-shaped constraining edge wraps the connecting line and the proximal end of the stent.

22. The artificial heart valve according to claim 21, wherein: The arc-shaped binding edge of each leaflet has a lower edge portion located at the proximal end and two opposite side edge portions, each of the side edge portions is fixed to the side edge portion of another adjacent leaflet to form a commissure, The free edge extends between the two side edge portions of the arc-shaped binding edge, and the proximal end of the stent matches the lower contour formed by the lower edge portions of the plurality of leaflets.

23. The artificial heart valve according to claim 20, wherein: The mesh structure includes a plurality of first mesh units and a plurality of second mesh units distributed along the circumferential direction. The plurality of leaflets are respectively attached to the corresponding second grid units or the corresponding cantilever struts and are independent of the adapter.

24. The artificial heart valve according to claim 23, further comprising a first covering layer, the first covering layer covering at least a portion of the inner side of the stent and having a skirt-like shape, the first covering layer comprising: A first portion is sutured with the plurality of second mesh units and at least partially sandwiched between the plurality of leaflets and the plurality of second mesh units; and / or The second part matches the proximal end of the stent in position and shape and is sutured to the corresponding part of the stent.

25. The artificial heart valve according to claim 24, wherein: The edge of the first covering layer at the distal end has a profile matching the plurality of frames of the mesh structure, the plurality of frames comprising: a distal border of one or more grid units, wherein the one or more grid units include the plurality of second grid units and the first grid unit adjacent to any second grid unit; a proximal border of the first grid unit that is not adjacent to any of the second grid units; A rod-shaped frame of one or two of the first grid units adjacent to any of the second grid units, wherein the rod-shaped frame is shared by the two adjacent first grid units.

26. The artificial heart valve according to claim 24, wherein: The first covering layer at least completely covers the plurality of second grid units, the first grid unit adjacent to any second grid unit, and the plurality of cantilever support rods; and / or At least one of the first grid cells is partially exposed by the first cover layer.

27. The artificial heart valve according to claim 24, further comprising a second covering layer covering the outer side of the stent and having a skirt-like shape, wherein the second covering layer comprises: a first portion, sewn to the plurality of second mesh units and the first portion of the first covering layer; and / or The second portion matches the proximal end of the stent in position and shape and is sutured to the corresponding portion of the stent and the second portion of the first covering layer.

28. The artificial heart valve according to claim 27, wherein: The edge of the second cover layer at the distal end has a contour matching the distal border of one or more of the second grid cells.

29. The artificial heart valve according to claim 27, wherein: The first covering layer and the second covering layer are integrated into a single covering layer, which is wrapped around the proximal end of the stent based on the connecting wire and the plurality of cantilever struts, and is at least partially sandwiched between the stent and the plurality of leaflets at the proximal end; or The first covering layer and the second covering layer are respectively implemented by different covering layers.

30. The artificial heart valve according to claim 27, wherein: Also includes: A base covering layer surrounds the inner peripheral surface and / or the outer peripheral surface of the respective adapters to prevent blood from flowing in directions other than the direction between the proximal opening and the distal opening of the adapter.

31. The artificial heart valve according to claim 30, wherein: The base cover layer is stitched to the first cover layer and / or the second cover layer.

32. The artificial heart valve according to claim 21, wherein: At least a portion of the arcuate binding edge of each leaflet is sutured a distance from the edge of the stent at the proximal end to a corresponding position on the outer peripheral surface of the stent.

33. The artificial heart valve according to claim 20, wherein: Each of the cantilever struts is provided with an opening at the proximal end, and the openings of the plurality of cantilever struts are softly connected via the connecting line, and the openings are selected from a hole, a groove and a gap; and / or The connecting wire is a metal wire or a suture wire.

34. The assembly method according to claim 20, wherein: Also includes: Use the connecting wire to softly connect the multiple cantilever support rods; Based on the connecting line and the plurality of cantilever struts, each of the leaflets is connected to the stent by suturing; as well as The designated adapter is selected and connected to the plurality of cantilever struts by suturing.

35. The assembly method according to claim 34, wherein: Each of the leaflets has an arc-shaped constraining edge and a free edge disposed in the support, wherein the free edge allows blood to flow from the proximal end to the distal end through the artificial heart valve when separated from the other leaflets, and inhibits blood from flowing from the distal end to the proximal end through the artificial heart valve when in contact with the other leaflets. Based on the connection line and the plurality of cantilever struts, the step of connecting each leaflet to the stent by suturing comprises: Based on the connecting line and the plurality of cantilever struts, at least a portion of the arc-shaped constraint edge of each leaflet is folded outward from the inside of the stent to the outer peripheral surface of the stent, so that the arc-shaped constraint edge wraps the connecting line and the proximal end of the stent; and At least a portion of the arcuate constraining edge is sutured to the proximal end of the stent.

36. The assembly method according to claim 35, wherein: The mesh structure includes a plurality of first mesh units and a plurality of second mesh units distributed along the circumferential direction. The plurality of leaflets are respectively attached to the corresponding second grid units and / or the corresponding cantilever struts and are independent of the adapter.

37. The assembly method according to claim 36, wherein: The artificial heart valve further includes a first covering layer covering at least a portion of the inner side of the stent and having a skirt-like shape, and the assembling method further includes: sewing a first portion of the first cover layer to the plurality of second mesh units to allow the first portion of the first cover layer to be at least partially sandwiched between the plurality of leaflets and the plurality of second mesh units; and / or The second portion of the first covering layer is sewn to the corresponding portion of the stent, and the second portion of the first covering layer matches the proximal end of the stent in position and shape.

38. The assembly method according to claim 37, wherein: The artificial heart valve further includes a second covering layer covering the outer side of the stent and having a skirt-like shape, and the assembling method further includes: stitching together a first portion of the second covering layer, the plurality of second grid units and a first portion of the first covering layer; and / or The second portion of the second covering layer is sewn together with the corresponding portion of the stent and the second portion of the first covering layer, the second portion of the second covering layer matching the proximal end of the stent in position and shape.

39. The assembly method according to claim 38, wherein: Also includes: Providing a single-piece covering layer as an integrated covering layer including the first covering layer and the second covering layer by laser cutting, the single-piece covering layer wraps around the proximal end of the stent based on the connecting line and the plurality of cantilever struts and is at least partially sandwiched between the stent and the plurality of leaflets at the proximal end; or The first covering layer and the second covering layer are provided independently of each other.

40. The assembly method according to claim 39, wherein: The artificial heart valve further includes a base covering layer surrounding the inner peripheral surface and / or the outer peripheral surface of the adapter to prevent blood from flowing in a direction other than a direction between the proximal opening and the distal opening of the adapter.

41. The assembly method according to claim 21, further comprising: The base cover layer is stitched to the first cover layer and / or the second cover layer.

42. The assembly method according to claim 16, wherein: The step of suturing at least a portion of the arcuate binding edge to the proximal end of the stent comprises: At least a portion of the arcuate restraining edge of each leaflet is sutured a distance from the edge of the stent at the proximal end to a corresponding position on the outer peripheral surface of the stent.

43. The assembly method according to claim 34, further comprising: A sewing ring is attached to the outer surface of the designated adapter.

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