Artificial heart valve frame, double-layer artificial heart valve frame, and artificial heart valve prosthesis

Abstract

The present application relates to the field of medical instruments, and provides an artificial heart valve frame, a double-layer artificial heart valve frame, and an artificial heart valve prosthesis. The artificial heart valve frame comprises a framework, an upper anchoring structure, and a lower anchoring structure. The framework comprises a valve frame main body. The upper anchoring structure is connected to the upper end of the framework and extends to the outside of the valve frame main body; the lower anchoring structure is connected to the lower end of the framework and extends to the outside of the valve frame main body. When the artificial heart valve frame is transitioned to a radially contracted state, the upper anchoring structure is elastically folded downward and toward the valve frame main body; and the lower anchoring structure is elastically folded upward and toward the valve frame main body. The present application alleviates the technical issue of existing valve stents having excessive length after compression, which affects the success rate of surgical operation and the feasibility of performing surgery via the atrial septal puncture approach, while also reducing surgical risks.

Description

Artificial heart valve stents, double-layer artificial heart valve stents, and artificial heart valve prostheses

[0001] Cross-references to related applications

[0002] This application claims priority to Chinese Patent Application No. 202410681033.0, filed on May 29, 2024, entitled “Artificial Heart Valve Frame, Double-Layer Artificial Heart Valve Frame and Artificial Heart Valve Prosthesis”, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to the technical field of medical devices, and in particular to a catheter-deliverable artificial heart valve stent, a double-layered artificial heart valve stent, and an artificial heart valve prosthesis. Background Technology

[0004] As shown in Figure 1, in the structure of the human heart, the mitral valve ensures that blood flows from the left atrium to the left ventricle, the tricuspid valve ensures that blood flows from the right atrium to the right ventricle, the interatrial septum is the tissue between the left and right atria, the mitral annulus is the intersection of the tissues between the left atrium, left ventricle and mitral valve leaflets, and the tricuspid annulus is the intersection of the tissues between the right atrium, right ventricle and tricuspid valve leaflets.

[0005] Transcatheter heart valve replacement involves inserting a sheath into the patient's heart to deliver an artificial heart valve prosthesis to the valve annulus region, thereby completing the artificial valve placement and restoring valve function. Transcatheter mitral valve replacement and transcatheter tricuspid valve replacement are used to treat congenital mitral stenosis or regurgitation, as well as tricuspid stenosis or regurgitation.

[0006] Taking mitral regurgitation as an example, due to congenital abnormalities or acquired lesions of the mitral valve, it cannot close completely when the left ventricle contracts, causing some of the blood flowing from the left atrium into the left ventricle to flow back into the left atrium, causing a series of pathological changes and clinical symptoms in the heart, which can lead to heart failure or even death in severe cases.

[0007] Mitral valve replacement surgery involves implanting an artificial valve to replace the original mitral valve, which has lost its function due to disease, thereby improving mitral regurgitation and alleviating or reconstructing the clinical symptoms caused by mitral stenosis.

[0008] Most existing mitral valve replacement stents are cylindrical in shape, and after anchoring, the elasticity of the stent itself provides radial support.

[0009] Existing transcatheter mitral valve replacement (TCV) procedures primarily utilize two approaches: transapical and transfemoral vein approaches. The transfemoral vein and transatrial septal approaches, compared to the transapical approach, result in smaller incisions, lower surgical risks, less patient discomfort, and shorter postoperative healing periods. However, due to the anatomical structure of the human body, the atrial septum and valve annulus plane are either perpendicular or at an angle. Therefore, during stent deployment, after the sheath tip carrying the stent exits from the atrial septum, the angle needs to be adjusted so that the stent-laden sheath tip is centered on the valve annulus and perpendicular to the annulus plane; this is the optimal deployment position. With existing transatrial septal stent deployments, the portion of the sheath containing the stent is relatively rigid after insertion, making bending difficult. Therefore, it needs to be inserted entirely into the atrium before bending, but the limited space in the atrium makes bending a challenging procedure in practice. This increases the failure rate and risk of the procedure. Furthermore, it makes it impossible to perform the procedure via transseptal puncture for some patients with smaller atria after dissection or those who do not have sufficient space for adjustment for other reasons.

[0010] In summary, in the existing technology, the length of the valve stent after compression is relatively long, which greatly limits the surgical approach using the transseptal approach. In particular, for stents that are too long after compression, they can only be used with the transapical approach and cannot be used with the transseptal approach, thus affecting the success rate and feasibility of the surgical procedure.

[0011] Summary of the Invention

[0012] The technical problem to be solved by this application is to provide a transcatheter artificial heart valve stent, a double-layer artificial heart valve stent, and an artificial heart valve prosthesis that are advantageous for shortening length when loaded.

[0013] The embodiments of this application adopt the following technical solutions:

[0014] This application provides an artificial heart valve stent, including a skeleton, an upper anchoring structure, and a lower anchoring structure. The skeleton includes a valve stent body. The upper anchoring structure is connected to the upper end of the skeleton and extends to the outside of the valve stent body. The lower anchoring structure is connected to the lower end of the skeleton and extends to the outside of the valve stent body. When the artificial heart valve stent transitions to a radially contracted state, the upper anchoring structure elastically folds downward and towards the valve stent body; the lower anchoring structure elastically folds upward and towards the valve stent body.

[0015] The artificial heart valve frame includes a valve frame body, meaning the frame may only include the valve frame body, or it may include other connecting structures in addition to the valve frame body. Optionally, but not limited to, the frame also includes a curved portion connected to the upper end of the valve frame body; the curved portion includes an upper curved section extending radially outward and downward and a lower curved section extending radially inward and downward from the lower end of the upper curved section; the upper anchoring structure is connected to the upper curved section.

[0016] Optionally, in the radially contracted state of the artificial heart valve, the upper anchoring structure and the lower anchoring structure overlap radially inside and outside the valve body.

[0017] Optionally, in the radially contracted state of the artificial heart valve, the lower anchoring structure is located inside the upper anchoring structure in the radial direction of the valve body.

[0018] Alternatively, in the radially contracted state of the artificial heart valve stent, the axial lengths of both the upper and lower anchoring structures are not greater than the axial length of the skeleton.

[0019] Optionally, the upper anchoring structure is a corolla-shaped structure, wherein the base of each petal unit is connected to the upper end of the skeleton, and the petal tips are arc-shaped free ends.

[0020] Optionally, the lower anchoring structure is a corolla-shaped structure, wherein the base of each petal unit is connected to the lower end of the skeleton, and the petal tips are arc-shaped free ends.

[0021] Optionally, the petal roots are connected to the upper or lower end of the skeleton via physical snap-fit.

[0022] Optionally, the upper anchoring structure includes multiple V-shaped petal units and multiple rhomboid petal units.

[0023] Optionally, the V-shaped petal units and the rhomboid petal units are arranged alternately, and the two ends of the V-shaped petal units are fixed or integrally connected to the adjacent rhomboid petal units; the inner tip of the rhomboid petal units is fixed or integrally connected to the petal frame body.

[0024] Optionally, the structure of the petiole frame body is a mesh cylinder. Optionally, the petiole frame body is formed in a ring or spiral shape.

[0025] In addition, this application embodiment also provides a double-layer artificial heart valve stent, which includes an inner stent and an outer stent, wherein the outer stent is the artificial heart valve stent described in the aforementioned optional embodiments, and the inner stent is located inside the valve stent body.

[0026] Optionally, in the radially contracted state of the double-layer artificial heart valve stent, the axial length of the outer stent's valve body is not greater than the axial length of the inner stent.

[0027] Optionally, the inner stent and the outer stent are separate structures. During implantation, the outer stent is delivered and released first, and then the inner stent is delivered and released into the outer stent.

[0028] Optionally, the inner side of the upper anchoring structure is provided with an end connecting rod to connect the outer support and the inner support.

[0029] Optionally, the main body of the inner support includes at least a plurality of V-shaped main support units connected end to end in the circumferential direction, and each V-shaped main support unit is provided with a connection hole at its top and bottom. The main body of the inner support is fixedly connected to the inside of the petiole body of the outer support through the connection hole.

[0030] Optionally, the main body of the inner support is provided with V-shaped, rhomboid, or other curved auxiliary beams.

[0031] In addition, this application embodiment also provides an artificial heart valve prosthesis, which includes the double-layer artificial heart valve stent provided in the foregoing embodiment and leaflets connected to the stent.

[0032] In addition, this application provides another artificial heart valve prosthesis, which includes the artificial heart valve frame and leaflets connected to the artificial heart valve frame provided in the foregoing embodiments.

[0033] The beneficial effects of the artificial heart valve stent provided in this application embodiment include, for example:

[0034] (1) The upper and lower anchoring structures play an anchoring function after release. During delivery, the artificial heart valve retracts radially within the delivery sheath. At this time, the upper anchoring structure of the artificial heart valve folds down and closer to the valve body, and the lower anchoring structure folds up and closer to the valve body. As a result, the axial length of the artificial heart valve after retraction is shorter, and the length of the hard segment of the delivery sheath after passing through the interatrial septum is smaller and more flexible. The angle adjustment is easier, and even a smaller left atrium can achieve a larger angle adjustment, which improves the adaptability of transseptal puncture implantation of valve prostheses to complex cases and anatomical structures.

[0035] (2) It can also be implanted through the apex of the heart. Regardless of which approach is chosen, the shorter length of the artificial heart valve after contraction can also result in a shorter distance for the delivery sheath to retract during release, which can release faster and reduce the problem of inaccurate anchoring caused by release. All of these greatly reduce the difficulty of the operation, reduce the degree of damage to the patient's tissues, and reduce the risk of the operation.

[0036] (3) After implantation and release into the valve region between the atrium and ventricle, the upper and lower anchoring structures rebound after release. The upper and lower anchoring structures clamp the patient's valve annulus and fit into the heart tissue at the expected release position. This causes no trauma to the heart tissue, and the implantation can achieve long-term anchoring. Furthermore, it maintains the structural morphology of the artificial heart valve prosthesis and provides long-term stable support for the various functions of the artificial heart valve.

[0037] The double-layer artificial heart valve stent and the artificial heart valve prosthesis provided in this application are both able to achieve all the beneficial effects that the artificial heart valve stent provided in the aforementioned embodiments can achieve because they each include the artificial heart valve stent provided in the aforementioned embodiments. Attached Figure Description

[0038] To more clearly illustrate the technical solutions in the specific embodiments of this application or the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0039] Figure 1 is a schematic diagram of the human heart's anatomical structure;

[0040] Figure 2 is a schematic diagram of the overall structure of the artificial heart valve prosthesis provided in the embodiment of this application in the inflated state;

[0041] Figure 3 is an isometric view of the overall structure of the artificial heart valve prosthesis provided in the embodiment of this application in an inflated state;

[0042] Figure 4 is a front view of a local stent structure of the artificial heart valve prosthesis provided in the embodiment of this application in an inflated state;

[0043] Figure 5 is a top view of the overall structure of the artificial heart valve prosthesis provided in the embodiment of this application in an inflated state;

[0044] Figure 6 is a schematic diagram of the overall structure of the artificial heart valve prosthesis under radial contraction state provided in the embodiment of this application;

[0045] Figure 7 is a schematic diagram of the overall structure of the artificial heart valve prosthesis provided in the embodiment of this application, in the expanded state of the internal stent.

[0046] Icons: 10-Outer support; 11-Petal frame body; 111-Bend; 12-Upper anchoring structure; 121-V-shaped petal unit; 122-Rhomboid petal unit; 123-End connecting rod; 13-Lower anchoring structure; 20-Inner support; 21-V-shaped main support unit; 221-Connecting hole; 22-Auxiliary beam; 30-Petal leaf. Detailed Implementation

[0047] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0048] Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0049] It should be noted that similar labels and letters in the accompanying drawings indicate similar items. Therefore, once an item is defined in one accompanying drawing, it does not need to be further defined and explained in subsequent accompanying drawings.

[0050] In the description of this application, it should be noted that the terms "upper end," "lower end," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product is in use. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application. In particular, in this embodiment, after the artificial heart valve stent or artificial heart valve prosthesis is delivered through a catheter and implanted into the patient's body, the upstream end in the direction of blood flow is its upper end, and the downstream end in the direction of blood flow is its lower end.

[0051] Furthermore, the terms “first,” “second,” “third,” “fourth,” etc., are used only to distinguish descriptions and should not be interpreted as indicating or implying relative importance.

[0052] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "set," "install," and "connect" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0053] The following detailed description of some embodiments of this application is provided in conjunction with the accompanying drawings. Unless otherwise specified, the following embodiments and features can be combined with each other.

[0054] As shown in Figure 1, in the structure of the human heart, the mitral valve ensures that blood flows from the left atrium to the left ventricle, the tricuspid valve ensures that blood flows from the right atrium to the right ventricle, the interatrial septum is the tissue between the left and right atria, the mitral annulus is the intersection of the tissues between the left atrium, left ventricle and mitral valve leaflets, and the tricuspid annulus is the intersection of the tissues between the right atrium, right ventricle and tricuspid valve leaflets.

[0055] Transcatheter heart valve replacement involves inserting a sheath into the patient's heart to deliver an artificial heart valve prosthesis to the valve area and open it, thereby completing the artificial valve placement and restoring valve function. Transcatheter mitral valve replacement and transcatheter tricuspid valve replacement are used to treat congenital mitral stenosis or regurgitation, as well as tricuspid stenosis or regurgitation.

[0056] Based on this, this application provides a catheter-delivered artificial heart valve stent, a double-layered artificial heart valve stent, and two artificial heart valve prostheses.

[0057] Referring to Figures 2 to 7, this embodiment provides an artificial heart valve prosthesis, which includes a double-layered artificial heart valve frame and leaflets 30. The double-layered artificial heart valve frame includes an inner stent 20 and an outer stent 10. The inner stent 20 is located inside the outer stent 10, and the leaflets 30 are connected to the inner stent 20. Artificial mitral or tricuspid leaflets can be selected as needed. Specifically referring to Figures 2 to 6, the outer stent 10 is an artificial heart valve frame, and its specific structure is as follows: The outer stent 10 includes a frame, an upper anchoring structure 12, and a lower anchoring structure 13. The frame includes a valve frame body 11. The upper anchoring structure 12 is connected to the upper end of the frame and extends to the outside of the valve frame body 11. The lower anchoring structure 13 is connected to the lower end of the frame and extends to the outside of the valve frame body 11. When the outer stent 10 changes to a radially contracted state, the upper anchoring structure 12 elastically folds downwards and towards the valve frame body 11; the lower anchoring structure 13 elastically folds upwards and towards the valve frame body 11. The valve frame body 11 has various specific structures, such as a mesh-like cylindrical shape as shown in Figures 2 to 6, or a ring-shaped or spiral shape (not shown) or other structures that can be radially compressed and radially expanded after being released into the patient's valve area. The inner stent 20 is located within the valve frame body 11 of the outer stent 10.

[0058] Optionally, but not limited to, in the radially contracted state of the double-layer artificial heart valve stent, the axial length of the valve body 11 of the outer stent 10 is not greater than the axial length of the inner stent 20, and optionally the two axial lengths are equivalent, so that the overall axial length of the artificial heart valve prosthesis is minimized after radial contraction.

[0059] In this embodiment, the inner stent 20 can be fixed or integrally connected with the outer stent 10, and be delivered and released simultaneously during implantation. Alternatively, the inner stent 20 can be a separate structure from the outer stent 10, in which case the outer stent 10 is delivered and released first, and then the inner stent 20 is delivered and released into the outer stent 10.

[0060] When the inner stent 20 can be fixed or integrally connected with the outer stent 10, there are various specific structural forms for the inner stent 20, such as, but not limited to, as shown in Figure 7, so that the main body of the inner stent 20 includes at least a plurality of V-shaped main stent units 21 connected end to end in the circumferential direction, and connection holes 221 are provided at the top and bottom of each V-shaped main stent unit 21. The main body of the inner stent 20 is fixedly connected to the inside of the valve frame body 11 of the outer stent 10 through the connection holes 221. The connection method can be, but is not limited to, connecting the main body of the inner stent 20 and the valve frame body 11 at the connection holes 221 by means of thread sewing, mechanical connection or welding. In addition, based on the V-shaped main support unit 21, but not limited to, additional V-shaped, rhomboid, or other curved auxiliary beams 22 can be provided to increase the support force of the inner support 20. In particular, as those skilled in the art should know, in this embodiment, the structural form of the inner support 20 is not limited to this. The main body of the inner support 20 can also be other hollow support, and the main body of the inner support 20 can also be provided with other structures such as barbs to pierce the original leaflet after implantation to enhance the stability after implantation.

[0061] This embodiment provides a double-layer artificial heart valve stent, which can be used as the double-layer artificial heart valve stent in the aforementioned embodiments. The double-layer artificial heart valve stent includes an inner stent 20 and an outer stent 10, with the inner stent 20 located within the valve body 11 of the outer stent 10. The structural view of the outer stent 10 can be obtained by referring to Figures 2 to 6 and their variations, and in conjunction with the relevant descriptions of the aforementioned embodiments. Specifically, it includes a skeleton, an upper anchoring structure 12, and a lower anchoring structure 13. The skeleton includes the valve body 11. The upper anchoring structure 12 is connected to the upper end of the skeleton and extends to the outside of the valve body 11. The lower anchoring structure 13 is connected to the lower end of the skeleton and extends to the outside of the valve body 11. When the outer stent 10 changes to a radially contracted state, the upper anchoring structure 12 elastically folds downward and closer to the valve body 11; the lower anchoring structure 13 elastically folds upward and closer to the valve body 11. The inner stent 20 can be fixed or integrally connected with the outer stent 10, and be delivered and released simultaneously during implantation. Alternatively, the inner stent 20 can be a separate structure from the outer stent 10, in which case the outer stent 10 is delivered and released first, and then the inner stent 20 is delivered and released into the outer stent 10.

[0062] This embodiment provides another artificial heart valve prosthesis that differs from the previous embodiments. It can be obtained by modifying the figures 2 to 7. The artificial heart valve prosthesis includes an artificial heart valve frame and leaflets 30 connected to the artificial heart valve frame. The leaflets 30 can be selected as artificial mitral leaflets or artificial tricuspid leaflets as needed.

[0063] Specifically, referring to Figures 2 to 6, the aforementioned artificial heart valve includes a skeleton, an upper anchoring structure 12, and a lower anchoring structure 13. The skeleton includes a valve body 11. The upper anchoring structure 12 is connected to the upper end of the skeleton and extends to the outside of the valve body 11. The lower anchoring structure 13 is connected to the lower end of the skeleton and extends to the outside of the valve body 11. When the artificial heart valve transitions to a radially contracted state, the upper anchoring structure 12 elastically folds downwards and towards the valve body 11; the lower anchoring structure 13 elastically folds upwards and towards the valve body 11. The valve body 11 has various specific structures, such as a grid-like cylindrical shape as shown in Figures 2 to 6, or a ring-shaped or spiral shape (not shown), or other structures that can be radially compressed and radially expanded after being released into the patient's valve area.

[0064] This embodiment provides an artificial heart valve stent, which can be used as the external stent 10 in the aforementioned embodiments, or as the artificial heart valve stent in the aforementioned embodiments. Its structure can be obtained by referring to Figures 2 to 6 and their variations.

[0065] Specifically, referring to Figures 2 to 6, the artificial heart valve frame provided in this embodiment includes a skeleton, an upper anchoring structure 12, and a lower anchoring structure 13. The skeleton includes a valve frame body 11. The upper anchoring structure 12 is connected to the upper end of the skeleton and extends to the outside of the valve frame body 11. The lower anchoring structure 13 is connected to the lower end of the skeleton and extends to the outside of the valve frame body 11. When the artificial heart valve frame transitions to a radially contracted state, the upper anchoring structure 12 elastically folds downwards and towards the valve frame body 11; the lower anchoring structure 13 elastically folds upwards and towards the valve frame body 11. The valve frame body 11 has various specific structures, such as a grid-like cylindrical shape as shown in Figures 2 to 6, or formed as an annular or spiral shape (not shown), or other structures that can be radially compressed and radially expanded after being released into the patient's valve area.

[0066] Whether used as the external stent 10 in the aforementioned embodiments or as an artificial heart valve stent, this embodiment can achieve the following beneficial effects:

[0067] (1) The upper anchoring structure 12 and the lower anchoring structure 13 perform the anchoring function after release. During delivery, the artificial heart valve retracts radially within the delivery sheath. At this time, the upper anchoring structure 12 of the artificial heart valve folds down and closer to the valve body 11, and the lower anchoring structure 13 folds up and closer to the valve body 11. As a result, the axial length of the artificial heart valve after retraction is shorter, and the length of the hard segment of the delivery sheath after passing through the interatrial septum is smaller and more flexible. The angle adjustment is easier, and even a smaller left atrium can achieve a larger angle adjustment, which improves the adaptability of transseptal puncture implantation of valve prostheses to complex cases and anatomical structures.

[0068] (2) It can also be implanted through the apex of the heart. Regardless of which approach is chosen, the shorter length of the artificial heart valve after contraction can also result in a shorter distance for the delivery sheath to retract during release, which can release faster and reduce the problem of inaccurate anchoring caused by release. All of these greatly reduce the difficulty of the operation, reduce the degree of damage to the patient's tissues, and reduce the risk of the operation.

[0069] (3) After implantation and release into the valve region between the atrium and ventricle, the upper anchoring structure 12 and the lower anchoring structure 13 rebound after being released. The upper anchoring structure 12 and the lower anchoring structure 13 clamp the patient's valve annulus and fit into the heart tissue at the expected release position. This causes no trauma to the heart tissue, and the implantation can achieve long-term anchoring. In addition, it maintains the structural shape of the artificial heart valve prosthesis and provides long-term stable support for the various functions of the artificial heart valve.

[0070] In summary, this embodiment provides an artificial heart valve stent; it also provides a double-layered artificial heart valve stent, which includes an inner stent 20 and an outer stent 10, the outer stent 10 being the aforementioned artificial heart valve stent, and the inner stent 20 being located within the valve body 11 of the outer stent 10; it also provides two types of artificial heart valve prostheses, one of which includes the aforementioned double-layered artificial heart valve stent and leaflets 30 connected to its inner stent 20, and the other artificial heart valve prosthesis includes the aforementioned artificial heart valve stent and leaflets 30 connected to the artificial heart valve stent. The structures of the embodiments of this application are based on the artificial heart valve stent structures provided in the embodiments, alleviating the technical problem that the existing valve stents are too long after compression, affecting the success rate of surgical operations and the feasibility of surgery via the transseptal puncture approach, while also reducing surgical risks.

[0071] Furthermore, the artificial heart valve stents described in the above embodiments also have a variety of optional structures:

[0072] First, in this embodiment, the framework of the artificial heart valve frame includes a valve frame body 11, indicating that the framework may only include the valve frame body 11, or it may include other connecting structures in addition to the valve frame body 11. Optionally, but not limited to, as shown in FIG2, in addition to the valve frame body 11, the framework also includes a curved portion 111 connected to the upper end of the valve frame body 11; the curved portion 111 includes an upper curved section extending radially outward and downward and a lower curved section extending radially inward and downward from the lower end of the upper curved section; the upper anchoring structure 12 is connected to its upper curved section. The structural design of the bend 111 allows the artificial heart valve to compress radially inward and elongate axially along the valve body 11 when it is radially contracted inside the delivery sheath. This pulls the upper anchoring structure 12 downward and towards the valve body 11 for elastic folding. This design facilitates the rapid folding of the upper anchoring structure 12 and improves the fit between the upper anchoring structure 12 and the valve body 11 under radial compression. It also reduces the diameter of the delivery sheath required for implantation, making it easier for the sheath to pass through tortuous blood vessels. Furthermore, the structural design of the bend 111 also allows the artificial heart valve to be secured in the atrium after implantation and release, thereby enhancing the anchoring function of the artificial heart valve after release.

[0073] In addition, in the optional structure of the artificial heart valve, in the radially contracted state of the artificial heart valve, the upper anchoring structure 12 and the lower anchoring structure 13 overlap radially inward and outward in the valve body 11, so that the artificial heart valve forms a three-layer structure in the radially contracted state, with the upper anchoring structure 12, the lower anchoring structure 13, and the valve body 11 radially overlapping, further shortening the axial length of the hard segment after the valve body 11 is radially contracted. Preferably, when the artificial heart valve is in a radially contracted state, the lower anchoring structure 13 is located inside the upper anchoring structure 12 in the radial direction of the valve body 11. When this structure is combined with the aforementioned structure in which a curved portion 111 is provided at the upper end of the valve body 11 and bulges outward in the radial direction of the valve body 11, it has the effect of strengthening the fit between the lower anchoring structure 13 and the valve body 11. Thus, both the upper anchoring structure 12 and the lower anchoring structure 13 are fitted or nearly fitted to the valve body 11, further reducing the diameter of the delivery sheath required during implantation, making it easier for the sheath to pass through tortuous blood vessels.

[0074] Preferably, the axial lengths of the upper anchoring structure 12 and the lower anchoring structure 13 are not greater than the axial length of the skeleton when the artificial heart valve is in radial contraction state, so as to minimize the overall axial length of the artificial heart valve during radial compression.

[0075] There are various options for the specific structural forms of the upper anchoring structure 12 and the lower anchoring structure 13 of the artificial heart valve stent. Among them, optional but not limited to, as shown in Figures 2 to 6, both the upper anchoring structure 12 and the lower anchoring structure 13 can be crown-shaped structures. The valve roots of each petal unit of the upper anchoring structure 12 are connected to the upper end of the skeleton, and the valve tips are arc-shaped free ends. The valve roots of each petal unit of the lower anchoring structure 13 are connected to the lower end of the skeleton, and the valve tips are arc-shaped free ends. The specific connection methods for connecting the valve roots to the upper or lower end of the skeleton include, but are not limited to, integral molding, physical snap-fit ​​connection through steel sleeves or other components, or connection through welding or other methods. After connection, the upper anchoring structure 12 and the lower anchoring structure 13 can elastically fold with their respective connection points as base points. In the free state after release, the upper anchoring structure 12 unfolds downward in a near-horizontal position, and the lower anchoring structure 13 unfolds upward in a near-horizontal position. In some alternative embodiments, the upper anchoring structure 12 or the lower anchoring structure 13 may be separately provided as the above-mentioned crown-shaped connection structure.

[0076] The anchoring structure described above allows the upper anchoring structure 12 and the lower anchoring structure 13 to form two clamping disc structures after release, holding the valve annulus between them. This improves the stability of the artificial heart valve after implantation, ensuring it does not shift under blood flow. The valve tips of the upper anchoring structure 12 and the lower anchoring structure 13 are both arc-shaped free ends to minimize damage to the patient's heart tissue.

[0077] Optionally, but not limited to, the upper anchoring structure 12 includes multiple V-shaped petal units 121 (open petal structures) and multiple rhomboid petal units 122 (closed petal structures); the V-shaped petal units 121 and the rhomboid petal units 122 are arranged alternately, and the two ends of the V-shaped petal units 121 are fixed or integrally connected to the adjacent rhomboid petal units 122; the inner tip of the rhomboid petal units 122 is fixed or integrally connected to the petal frame body 11.

[0078] To facilitate the connection between the outer support 10 and the inner support 20 when used with the inner support 20, optionally, an end connecting rod 123 is provided on the inner side of the upper anchoring structure 12.

[0079] Finally, it should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. Similar or identical parts between embodiments can be referred to mutually. The above embodiments in this specification are only used to illustrate the technical solutions of this application and are not intended to limit it. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features. These modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application. Industrial applicability

[0080] This application provides an artificial heart valve stent, a double-layer artificial heart valve stent, and an artificial heart valve prosthesis, which alleviates the technical problems of the existing valve stents being too long after compression, affecting the success rate of surgical operations and the feasibility of surgery via the transseptal puncture approach, while also reducing surgical risks.

[0081] Furthermore, it is understood that the artificial heart valve stent, double-layer artificial heart valve stent, and artificial heart valve prosthesis of this application are reproducible and can be widely used in the field of medical devices.

Claims

1. A prosthetic heart valve stent, characterized by: Comprising: a skeleton, the skeleton comprising a frame body (11); an upper anchoring structure (12) connected to the upper end of the skeleton and extending outside the frame body (11); a lower anchoring structure (13) connected to the lower end of the skeleton and extending outside the frame body (11); when the artificial heart valve frame is transformed into a radially contracted state, the upper anchoring structure (12) is elastically folded downward and close to the frame body (11); the lower anchoring structure (13) is elastically folded upward and close to the frame body (11).

2. The artificial heart valve frame of claim 1, wherein: The skeleton further comprises a curved portion (111) connected to the upper end of the frame body (11); the curved portion (111) comprises an upper curved segment extending radially outward and downward, and a lower curved segment extending radially inward and downward from the lower end of the upper curved segment; the upper anchoring structure (12) is connected to the upper curved segment.

3. The artificial heart valve frame according to claim 1 or 2, characterized in that: In the radially contracted state of the artificial heart valve frame, the upper anchoring structure (12) and the lower anchoring structure (13) are radially overlapped inside and outside the frame body (11).

4. The artificial heart valve frame of claim 3, wherein: In the radially contracted state of the artificial heart valve frame, the lower anchoring structure (13) is located inside the upper anchoring structure (12) in the radial direction of the frame body (11).

5. The artificial heart valve frame according to claim 1 or 2, characterized in that: In the radially contracted state of the artificial heart valve frame, the axial length of the upper anchoring structure (12) and the axial length of the lower anchoring structure (13) are both not greater than the axial length of the skeleton.

6. The artificial heart valve frame according to claim 1 or 2, characterized in that: The upper anchoring structure (12) is a corolla structure, the petiole of each petal unit of the corolla structure is connected to the upper end of the skeleton, and the petal tip of each petal unit is a circular arc free end.

7. The artificial heart valve frame according to claim 1 or 2, characterized in that: The lower anchoring structure (13) is a corolla structure, the petiole of each petal unit of the corolla structure is connected to the lower end of the skeleton, and the petal tip of each petal unit is a circular arc free end.

8. The artificial heart valve frame according to claim 6 or 7, characterized in that: The petiole is connected to the upper end or the lower end of the skeleton by physical clamping.

9. The artificial heart valve frame according to any one of claims 1-8, characterized in that: The upper anchoring structure (12) comprises a plurality of V-shaped petal units (121) and a plurality of rhombic petal units (122).

10. The artificial heart valve frame of claim 9, wherein: The V-shaped petal units (121) and the rhombic petal units (122) are arranged alternately, and the two ends of the V-shaped petal units (121) are fixed or integrally connected to adjacent rhombic petal units (122); the inner side tip of the rhombic petal unit (122) is fixed or integrally connected to the frame body (11).

11. The artificial heart valve frame according to any one of claims 1-10, characterized in that: The structure of the frame body (11) is a grid cylinder.

12. The artificial heart valve frame according to any one of claims 1-10, characterized in that: The frame body (11) is formed into a ring shape or a spiral shape.

13. A two-layered prosthetic heart valve stent, characterized by: Comprising an inner stent (20) and an outer stent (10), the outer stent (10) is the artificial heart valve frame according to any one of claims 1-7; The inner stent (20) is located inside the frame body (11).

14. The two-tiered prosthetic heart valve frame according to claim 8, wherein: In the radially contracted state of the double-layer artificial heart valve frame, the axial length of the frame body (11) of the outer stent (10) is not greater than the axial length of the inner stent (20).

15. The two-layered prosthetic heart valve frame according to claim 13 or 14, characterized in that: The inner stent (20) and the outer stent (10) are in a split structure, and when implanted, the outer stent (10) is first delivered and released, and then the inner stent (20) is delivered and released inside the outer stent (10).

16. The two-tiered prosthetic heart valve frame according to any one of claims 13-15, wherein: The inner side of the upper anchoring structure (12) is provided with an end connecting rod (123) to connect the outer stent (10) and the inner stent (20).

17. The two-layered prosthetic heart valve frame according to any one of claims 13-16, characterized in that: The main body of the inner stent (20) comprises at least a plurality of V-shaped main stent units (21) connected end to end in the circumferential direction, and a connecting hole (221) is arranged at the top end and the bottom end of each V-shaped main stent unit (21), and the main body of the inner stent (20) is fixedly connected to the inside of the petal stent body (11) of the outer stent (10) through the connecting hole (221).

18. The two-tiered prosthetic heart valve frame according to any one of claims 13-17, wherein: The main body of the inner stent (20) is provided with a V-shaped or rhombic or other curved auxiliary beam (22).

19. A prosthetic heart valve prosthesis, characterized by: The double-layer artificial heart valve stent according to any one of claims 13-18 and the valve leaflet (30) connected to the inner stent (20).

20. A prosthetic heart valve prosthesis, characterized by: The artificial heart valve stent according to any one of claims 1-12 and the valve leaflet (30) connected to the artificial heart valve stent.

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