A prosthetic heart valve and transcatheter heart valve replacement system

Abstract

The utility model relates to a kind of artificial heart valve and percutaneous heart valve replacement system, artificial heart valve includes valve support, first sealing element, second sealing element and elastic contraction element;Valve support is sequentially provided with multiple grid groups arranged in circumference from outflow end to inflow end;First sealing element is covered on the outer surface of valve support, at least cover at least two groups of grid groups close to inflow end;Second sealing element is arranged on the outside of first sealing element;Two ends of the elastic contraction element are connected with the first sealing element and / or the second sealing element;Elastic contraction element can contract in the expansion state of valve support, and drive second sealing element to form the three-dimensional structure of circumferential continuous undulation.

Description

Technical Field

[0001] This utility model relates to the field of medical devices for cardiac surgery, and in particular to an artificial heart valve and a transcatheter heart valve replacement system. Background Technology

[0002] In recent years, transcatheter valve replacement has become an important method for treating severe valvular diseases. One of the main problems faced by transcatheter valve replacement is paravalvular leakage. Paravalvular leakage has a variety of causes, including the inability to remove the patient's original degenerated or calcified valve during the operation, as well as the patient's own anatomical characteristics such as non-circular valve annulus.

[0003] Existing artificial aortic valves typically feature a single-layer external seal on the inflow side, attempting to reduce paravalvular leakage by increasing the contact area with the valve annulus. This design has two significant drawbacks: firstly, the stent elongates axially under compression, and its apex can easily puncture the seal, damaging the delivery device or patient tissue; secondly, the single-layer seal structure struggles to adapt to complex anatomical structures, especially when the patient's valve annulus is severely calcified or irregularly shaped, failing to form an effective seal. To address the issue of the stent apex puncturing the seal, existing technologies often add an additional protective element at the stent apex. However, this increases manufacturing complexity and may enlarge the overall profile, hindering interventional surgical procedures.

[0004] Furthermore, existing seals often fail to fit snugly to the individualized anatomy of patients, resulting in poor sealing. This problem is particularly pronounced for patients with unique anatomical structures or severe calcifications. Utility Model Content

[0005] This utility model discloses an artificial heart valve and a transcatheter heart valve replacement system, aiming to solve the technical problems existing in the prior art. This utility model adopts the following technical solution: In a first aspect, embodiments of the present invention provide an artificial heart valve, comprising: - Valve stent, the valve stent has an inflow end and an outflow end, and the valve stent has multiple circumferentially arranged grid groups arranged sequentially from the outflow end to the inflow end; - A first seal is applied to the outer surface of the valve stent, and the first seal covers at least two sets of mesh near the inflow end; - A second seal is disposed outside the first seal; - Multiple elastic contractile elements, the two ends of which are connected to a first seal and / or a second seal; the elastic contractile elements are configured to contract in the expanded state of the valve stent and drive the second seal to form a circumferentially continuous undulating three-dimensional structure.

[0006] As a preferred technical solution, the elastic contractile elements are arranged in multiple rows along the circumference of the valve stent, and each row contains at least one elastic contractile element extending axially. The elastic contractile element includes an elastic strip-shaped structure configured to be in an axially stretched state when the valve stent is in a contracted state, and to contract to a non-stretched state when the valve stent is in an expanded state, thereby pulling the second seal to contract axially, forming a three-dimensional structure.

[0007] As a preferred technical solution, the valve stent includes a first grid group to an Nth grid group arranged sequentially from the outflow end to the inflow end, wherein N≥3; At least one set of non-end grid groups has a mesh size larger than that of at least one axially adjacent grid group. The non-end grid groups are matched to the position that abuts against the surrounding tissue after implantation, and the grid closest to the inflow end is suitable for matching the position below the valve annulus plane.

[0008] As a preferred technical solution, the valve stent includes a first grid group, a second grid group, a third grid group, and a fourth grid group arranged sequentially from the outflow end to the inflow end; The third grid group corresponds to the position where it contacts the surrounding tissue after implantation, and the mesh size of the third grid group is larger than that of the second and fourth grid groups.

[0009] As a preferred technical solution, the first seal covers at least the third and fourth grid groups, and the coverage range of the second seal along the valve stent axis does not exceed the coverage range of the first seal along the valve stent axis.

[0010] As a preferred technical solution, one end of the second seal is fixed to the outside of the valve stent, and the other end is folded from the inflow end to the inside of the valve stent and fixed; the second seal can move axially with the radial dimension change of the valve stent and always cover the inflow end.

[0011] As a preferred technical solution, both the first and second seals cover the second to fourth grid groups, and the elastic contraction element is disposed on the inner surface of the second seal, and its distribution area is limited to the positions corresponding to the second and third grid groups.

[0012] As a preferred technical solution, the first sealing element and the second sealing element cooperate with each other in the corresponding area of ​​the fourth grid group to form an annular sealing cavity. A flexible filling element is provided in the annular sealing cavity. The flexible filling element is selected from at least one of liquid-absorbing and swelling materials, elastic film materials, biocompatible sponge materials, and fiber aggregates.

[0013] As a preferred technical solution, the second seal is provided with multiple fluid passage holes distributed circumferentially, which are used to guide blood into the annular sealing cavity.

[0014] As a preferred technical solution, the valve stent is provided with three leaflet joint fixing windows along the circumference for fixing the connection of adjacent artificial leaflets. The elastic contractile element is disposed on the outer surface of the first seal, and there are three rows of elastic contractile elements that correspond one-to-one with the three leaflet joint fixation windows in the axial direction; the elastic contractile elements that correspond to the leaflet joint fixation windows in the axial direction all contain radiopaque material to provide positioning marks during implantation.

[0015] As a preferred technical solution, the elastic contraction element corresponding to the leaflet-joint fixed window in the axial direction is configured as follows: The elastic shrink element is entirely composed of a developing material; Alternatively, the elastic shrinking element is made of a composite weave of developable and non-developable materials, making it recognizable under imaging equipment.

[0016] As a preferred technical solution, in the expanded state of the valve stent, the portion of the second seal located on the outer side of the valve stent has a micro-rough surface structure to promote endothelial cell attachment and growth; the portion of the second seal located on the inner side of the valve stent has a smooth surface structure to prevent excessive endothelial growth from affecting hemodynamic characteristics.

[0017] As a preferred technical solution, the micro-rough surface structure is formed by at least one of the following methods: A loose fiber structure is reserved during the weaving process; Alternatively, a low-density weaving process can be used; Alternatively, the material surface can be roughened.

[0018] As a preferred technical solution, elastic contraction elements are respectively disposed on the first sealing element and the second sealing element; The elastic contraction element disposed on the first seal is located on its outer surface and covers only the areas corresponding to the second and third grid groups; The elastic contraction element disposed on the second seal is located on its inner surface and covers only the area corresponding to the fourth grid group.

[0019] As a preferred technical solution, the elastic contraction element disposed on the first sealing element and the elastic contraction element disposed on the second sealing element are spatially configured in the following manner: Aligned with each other axially; Alternatively, they can be staggered along the axial direction to form a spatially staggered structure.

[0020] As a preferred technical solution, the elastic contraction element disposed on the second seal adopts at least the following spatial configuration: It is tilted at a predetermined angle relative to the central axis of the valve stent; Alternatively, when multiple elastic contraction elements are distributed circumferentially, adjacent elastic contraction elements are located in different cross-sectional planes in the axial direction, forming a stepped distribution structure.

[0021] Secondly, embodiments of the present invention provide a transcatheter heart valve replacement system, including a delivery device and a releasable artificial heart valve connected to the distal end of the delivery device, wherein the artificial heart valve is an artificial heart valve as described in any of the preceding claims; the artificial heart valve is configured as a balloon-expandable artificial valve, suitable for transcatheter aortic valve replacement.

[0022] One embodiment of the above-described utility model has the following advantages or beneficial effects: This utility model mainly provides an artificial heart valve and a transcatheter heart valve replacement system. The artificial heart valve effectively solves the paravalvular leakage problem of artificial heart valves in the prior art through the cooperation of a valve stent, a first sealing element, a second sealing element, and an elastic contractile element.

[0023] In one embodiment of this utility model, the valve stent is provided with four sets of mesh structures from the outflow end to the inflow end. The third mesh set has a larger mesh size, which can accurately match the position of the valve stent against the surrounding tissue after implantation, significantly improving the anchoring stability of the valve stent.

[0024] In one embodiment of this invention, a first sealing element and a second sealing element are sequentially provided on the outer surface of the valve stent. The first sealing element covers the outer surface of the valve stent and provides leakage prevention performance, while the second sealing element is disposed outside the first sealing element and folded to the inner side of the valve stent. It can move axially with the radial dimension change of the valve stent and always covers the apex of the inflow end to provide buffer protection and prevent the apex of the inflow end of the valve stent from piercing the sealing element and causing damage to the delivery device or surrounding tissue.

[0025] In one embodiment of this utility model, the two sealing elements form an annular sealing cavity in the corresponding area of ​​the fourth grid group, and preferably have a flexible filling element. At the same time, the second sealing element can also be further provided with a liquid passage hole to guide blood into the annular sealing cavity, which further enhances the sealing effect.

[0026] In one embodiment of this invention, the circumferentially arranged elastic contractile elements can be stretched in the compressed state of the valve stent and contracted in the expanded state, thereby driving the second seal to form a circumferentially continuous undulating three-dimensional structure. This three-dimensional structure significantly improves the matching between the valve and the irregular valve annulus, further reducing the risk of paravalvular leakage. More preferably, those elastic contractile elements that correspond axially to the leaflet joint fixation window preferably contain radiopaque material, which can provide precise positioning marks during implantation, helping physicians to align the leaflet joint point of the artificial valve with the leaflet joint of the native aortic valve, effectively preventing the artificial valve leaflet from obstructing the coronary artery ostium.

[0027] In one embodiment of this invention, the portion of the second seal located on the outer side of the valve stent has a micro-rough surface structure that can promote endothelial cell attachment and growth, while the inner portion is configured with a smooth surface structure to prevent excessive endothelial growth from affecting hemodynamic characteristics. This differentiated structural design can effectively balance the clinical needs of tissue integration and smooth blood flow.

[0028] In one embodiment of this utility model, elastic contraction elements may be respectively provided on the first seal and the second seal. The elastic contraction elements provided on the two seals may be configured in various distribution patterns to provide various three-dimensional structures to enhance adaptability to different patients.

[0029] As a balloon-expandable aortic valve, this invention is applicable to transcatheter aortic valve replacement surgery, successfully solving problems such as paravalvular leakage, unstable implantation, and positioning difficulties in the prior art, and providing a safer and more effective artificial heart valve solution for transcatheter aortic valve replacement surgery. Attached Figure Description

[0030] To more clearly illustrate the technical solutions of the embodiments of this utility model, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of this utility model. The illustrative embodiments of this utility model and their descriptions explain this utility model and do not constitute an improper limitation of this utility model. In the accompanying drawings: Figure 1 This is a schematic diagram of the valve stent structure disclosed in one embodiment of the present invention; Figure 2 This is a front view of a valve stent disclosed in one embodiment of the present invention; Figure 3 This is a schematic diagram showing the structural fit of the valve stent, the first sealing member, and the second sealing member disclosed in one embodiment of the present utility model. Figure 4 for Figure 3 Front view; Figure 5 for Figure 4Sectional view along line AA; Figure 6 for Figure 5 A magnified view of a portion of the image; Figure 7 This is a schematic diagram of the structure of the artificial heart valve in a compressed state disclosed in one embodiment of the present invention; Figure 8 for Figure 7 Front view; Figure 9 This is a schematic diagram of the structure of an artificial heart valve disclosed in one embodiment of the present invention; Figure 10 This is a schematic diagram of the structure of an artificial heart valve disclosed in another embodiment of the present invention; Figure 11 for Figure 10 Front view; Figure 12 for Figure 11 BB-direction sectional view; Figure 13 for Figure 12 A magnified view of a portion of the image; Figure 14 This is a schematic diagram of the structure of an artificial heart valve disclosed in another embodiment of the present invention; Figure 15 This is a schematic diagram of the structure of an artificial heart valve disclosed in another embodiment of the present invention; Figure 16 This is a cross-sectional view of an artificial heart valve disclosed in one embodiment of the present invention; Figure 17 This is a schematic diagram of the structure of an artificial heart valve disclosed in one embodiment of the present invention; Figure 18 for Figure 17 Front view; Figure 19 for Figure 18 CC-direction sectional view; Figure 20 for Figure 19 A magnified view of a portion of the image; Figure 21 This is a schematic diagram of the structure of an artificial heart valve disclosed in another embodiment of the present invention.

[0031] Explanation of reference numerals in the attached figures: Valve stent 10, first grid group 11, leaflet joint fixation window 111, second grid group 12, third grid group 13, fourth grid group 14, first seal 20, second seal 30, annular sealing cavity 31, fluid passage hole 32, elastic contraction element 40, three-dimensional structure 50. Detailed Implementation

[0032] To make the objectives, technical solutions, and advantages of this utility model clearer, the technical solutions of this utility model will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this utility model, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly stated otherwise.

[0033] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance. The term "proximal end" refers to the end along the length of the artificial heart valve or delivery device, closer to the operator; the term "distal end" refers to the end along the length of the artificial heart valve or delivery device, farther from the operator.

[0034] Those skilled in the art will understand that, in order to achieve their respective functions and meet the requirements of surgical procedures, the specific shape, size, angle, etc., of each structure can be adaptively adjusted. Obviously, the described embodiments are only a part of the embodiments of this utility model, and not all of them. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of this utility model.

[0035] To address the technical problems existing in the prior art, in one embodiment of this utility model, an artificial heart valve is provided, preferably suitable for transcatheter aortic valve replacement, and preferably configured as a balloon-expandable artificial valve, made of medical stainless steel or cobalt-chromium alloy by laser cutting. The artificial heart valve can be delivered to the target position by compression through a delivery catheter, and the radial expansion and anchoring of the valve stent 10 is achieved by balloon expansion. After the balloon expansion is completed, the balloon retracts and is withdrawn, while the artificial heart valve remains in an expanded state and fixed at the target position, supporting the normal opening and closing of the artificial valve leaflet and restoring the unidirectional blood flow function of the heart.

[0036] Compared to self-expanding artificial valves, balloon-expandable artificial valves are easier to control in terms of positioning, reducing the risk of valve displacement. In addition, they expand more evenly during deployment and can apply greater radial force, making the natural valve annulus closer to the ideal circle, thereby reducing the incidence of paravalvular leakage, especially suitable for patients with calcification or specific anatomical structures.

[0037] In one embodiment, the artificial heart valve includes a valve stent 10, a first seal 20, a second seal 30, and a plurality of elastic contractile elements 40; such as Figures 3-6The first sealing element 20 and the second sealing element 30 sequentially cover the outer side of the valve stent 10, forming an outer skirt. A plurality of elastic contractile elements 40 are circumferentially disposed on the first sealing element 20 and / or the second sealing element 30. Each elastic contractile element 40 extends axially and can drive the second sealing element 30 to form a continuously circumferentially undulating three-dimensional structure 50, such as... Figure 10 .

[0038] like Figure 1 , Figure 2 In some embodiments, the valve stent 10 is configured in a compressed state during delivery and inflated into an expanded state by a balloon after being released at the target location. After radial expansion, the axial length of the valve stent 10 is shortened, and its outline is cylindrical. When the artificial heart valve is suitable for aortic valve replacement, since the aortic valve is composed of three leaflets, the valve stent 10 is also provided with three artificial leaflets to replace the physiological function of the original leaflets. The valve stent 10 is provided with three leaflet joint fixing windows 111 around its circumference to fix the connection of adjacent artificial leaflets.

[0039] In some embodiments, the valve stent 10 has an inflow end and an outflow end along its axial direction; taking aortic valve replacement as an example, after the artificial heart valve is released in the heart, the inflow end corresponds to the left ventricular side for blood pumping in, and the outflow end corresponds to the aortic side for blood pumping out; the valve stent 10 has a plurality of circumferentially arranged grid groups arranged sequentially from the outflow end to the inflow end, each grid group including several interconnected polygonal grid structures, each grid structure enclosing a mesh opening; adjacent grid structures are preferably connected by wave rods or nodes, wherein the polygonal grid can be selected as rhomboid, pentagonal, hexagonal or other units that can form a closed shape, the grid structures in the same grid group preferably have the same polygonal shape, and the grid structures in adjacent grid groups can be selected as the same or different polygonal shapes.

[0040] In some embodiments, the grid group closest to the inflow end is adapted to be positioned below the annular plane, and the specific release depth can be adjusted according to clinical needs and the patient's specific anatomy. When the grid group closest to the inflow end is positioned below the annular plane, this configuration provides a more stable anchoring effect, preventing the artificial heart valve from shifting towards the aorta due to blood flow impact after implantation, thus enhancing the positional stability of the artificial heart valve.

[0041] In some embodiments, the mesh size of at least one set of non-end mesh groups is larger than the mesh size of its axially adjacent mesh groups. The larger mesh size can provide more accommodating space for the first seal 20 and the second seal 30 in the folded state, so as to reduce the outer diameter of the artificial heart valve during delivery. At the same time, the larger mesh size can also allow the valve stent 10 to expand more fully at the valve annulus, filling the gap between the valve annulus and the valve stent 10, so as to better accommodate irregular disease structures.

[0042] In some embodiments, the valve stent 10 includes a first grid group 11 to a Nth grid group arranged sequentially from the outflow end to the inflow end, wherein N≥3; the aforementioned non-end grid groups correspond to the positions that abut against the surrounding tissue after implantation, and their mesh opening size is larger than the mesh opening size of at least one axially adjacent grid group.

[0043] Specifically, N can take values ​​of 3, 4, 5, or more. Different N values ​​correspond to different axial distribution densities of the grid groups. A larger N value indicates a denser grid arrangement along the axial direction of the valve stent 10, providing more refined mechanical performance zoning. Conversely, a smaller N value indicates a looser grid arrangement along the axial direction of the valve stent 10, with each grid group having a relatively larger axial span, thus achieving a larger mesh size while ensuring the overall strength of the valve stent 10. When multiple grid groups simultaneously abut against surrounding tissue after implantation, these non-end grid groups abutting against the tissue can be configured to have a larger mesh size to improve tissue adhesion.

[0044] like Figure 2 In some embodiments, N is 4, that is, the valve stent 10 includes a first grid group 11, a second grid group 12, a third grid group 13 and a fourth grid group 14 arranged sequentially from the outflow end to the inflow end. The third grid group 13 corresponds to the position that matches the surrounding tissue after implantation, that is, the position of the valve annulus plane, and the fourth grid group 14 corresponds to the position of the left ventricular outflow tract below the valve annulus. The mesh size of the third grid group 13 is preferably larger than the mesh size of the second grid group 12 and the fourth grid group 14, so as to reduce the interference of the stent skeleton on the first seal 20, the second seal 30 and the valve annulus tissue, so that they can better adapt to the irregular or calcified valve annulus surface.

[0045] like Figures 3-6 In some embodiments, both the first seal 20 and the second seal 30 are configured as flexible membrane structures, and both may be made of the same or different biocompatible materials. In some embodiments, the first seal 20 and the second seal 30 may be made of polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), polyester fiber, polyurethane, or composite materials with special surface treatment.

[0046] In some embodiments, the first sealing member 20 is applied to the outer surface of the valve stent 10 and can be fixed to the surface of the valve stent 10 by a suturing process. It covers at least the third mesh group 13 and the fourth mesh group 14 for fitting with the valve annulus to reduce paravalvular leakage. The second sealing member 30 is disposed outside the first sealing member 20. One end of the second sealing member 30 is fixed to the outside of the valve stent 10, and the other end is folded from the inflow end to the inside of the valve stent 10 and fixed. Except for the two ends of the second sealing member 30, other sections are not fixed to the valve stent 10, so that the second sealing member 30 can move axially with the radial collapse and expansion of the valve stent 10 and always cover the inflow end to effectively protect the apex of the valve stent 10 and prevent the mesh apex at the end of the valve stent 10 from piercing the second sealing member 30, thereby causing damage to the delivery device or surrounding tissue.

[0047] In some embodiments, the axial length of the second seal 30 is adapted to the changes in the working state of the valve stent 10. When the valve stent 10 is in a compressed state, the axial length of the valve stent 10 reaches its maximum value. At this time, the axial dimension of the second seal 30 is preferably configured to be greater than or equal to the length of the corresponding coverage area in the compressed state of the valve stent 10, so that the second seal 30 remains in a naturally extended state, rather than being stretched by the axial extension of the valve stent 10.

[0048] Specifically, by configuring the dimensions of the second seal 30 with an appropriate amount of redundancy, on the one hand, the second seal 30 is prevented from being punctured or damaged by the end of the valve stent 10 due to excessive tension when the valve stent 10 is compressed, thus improving safety during delivery; on the other hand, when the valve stent 10 expands and is accompanied by axial shortening, the second seal 30 will have sufficient length redundancy, and can form a circumferentially continuous undulating three-dimensional structure 50 under the action of the elastic contraction element 40, so that the second seal 30 can effectively adapt to the irregular valve annulus surface and form a dynamic sealing mechanism to avoid paravalvular leakage.

[0049] like Figures 7-10 In some embodiments, the elastic contractile elements 40 are arranged in multiple rows circumferentially, each row containing at least one axially extending elastic contractile element 40, and both ends of each elastic contractile element 40 are fixedly connected to the first seal 20 and / or the second seal 30. The elastic contractile elements 40 are configured to be stretched under the compressed state of the valve stent 10, such as... Figure 7 , Figure 8 When the valve stent 10 is in an expanded state, it contracts, causing the second sealing element 30 to form a circumferentially continuous undulating three-dimensional structure 50, such as... Figure 10 , Figure 11 This three-dimensional structure 50 can significantly enhance the contact area and fit between the seal and the irregular valve annular surface, effectively reducing the risk of periocular leakage while maintaining the slim profile of the delivery system.

[0050] In some embodiments, the elastic contractile element 40 is an elastic strip-shaped structure that can be in an axially stretched state when the valve stent 10 is in a contracted state, and contract to a non-stretched state when the valve stent 10 is in an expanded state, and pull the second seal 30 to contract axially to form a three-dimensional structure 50.

[0051] Optionally, in the circumferentially arranged multiple rows of elastic contraction elements 40, only one elastic contraction element 40 is configured in each row, or multiple elastic contraction elements 40 are arranged in each row along the axial direction.

[0052] Specifically, when the valve stent 10 is in a compressed state, the first seal 20 and / or the second seal 30 are stretched as the valve stent 10 extends axially, and the elastic contractile element 40 is also forcibly stretched to a longer state, such as... Figure 7 , Figure 8 When the valve stent 10 expands and shortens axially, the elastic contractile element 40, due to its inherent elastic properties, retracts to its natural length, thereby pulling the second seal 30 to form a circumferentially continuous wave-like convex structure, i.e., the aforementioned three-dimensional structure 50, as shown below. Figure 10 , Figure 11 .

[0053] In some embodiments, the elastic contractile element 40 may be made of materials such as silicone rubber, medical-grade polyurethane elastomer, or thermoplastic elastomer. These materials all have excellent elastic recovery properties and biocompatibility, and can maintain their elastic characteristics for a long time in the human implantation environment. The elastic contractile element 40 is preferably configured as a single-layer circumferential arrangement along the valve stent 10 to avoid an increase in overall thickness due to multi-layer stacking, which would affect the ability of the artificial heart valve to pass through the delivery device.

[0054] like Figure 9 In other embodiments, the elastic contractile element 40 may be made of a material with shape memory properties, such as a nickel-titanium alloy. In this embodiment, the elastic contractile element 40 is pre-shaped into a radially outward arc-shaped bend. When the valve stent 10 is in a compressed state, the elastic contractile element 40 will deform to a state close to axial straightness. After the valve stent 10 is released and expanded, the elastic contractile element 40 returns to the pre-shaped arc shape and drives the second seal 20 to form a circumferentially continuous three-dimensional structure 50.

[0055] In some embodiments, the elastic contraction element 40 is connected to the first seal 20 and / or the second seal 30 in the following manner: At least a plurality of perforations arranged axially are pre-formed on the second seal 30. When the elastic contraction element 40 is provided on the first seal 20, both the first seal 20 and the second seal 30 are pre-formed with a plurality of perforations arranged axially.

[0056] If the elastic contraction element 40 is connected to the second seal 30, and when multiple elastic contraction elements 40 are arranged in each column along the axial direction, the two ends of each (in the stretched state) elastic contraction element 40 are respectively inserted into a perforation of the second seal 30 and fixed; when one elastic contraction element 40 is arranged in each column along the axial direction, the elastic contraction element 40 passes through the corresponding perforation on the second seal 30 at multiple predetermined positions along its axial length and is fixed, forming a wave-shaped connection structure that runs up and down.

[0057] If the elastic contractile element 40 is connected to the first seal 20, since the first seal 20 directly covers and is fixed to the outer surface of the valve stent 10, the elastic contractile element 40 needs to pass through the corresponding perforations on the first seal 20 and the second seal 30. Specifically, when multiple elastic contractile elements 40 are arranged axially in each row, one end of each elastic contractile element 40 is fixed to the outer surface of the first seal 20, and the other end passes through the corresponding perforations on the first seal 20 and the second seal 30 in sequence before being fixed; when one elastic contractile element 40 is arranged axially in each row, one end of the elastic contractile element 40 is fixed to the outer surface of the first seal 20, and the other end passes through several corresponding perforations on the first seal 20 and the second seal 30 at several predetermined positions along its axial length, so that the elastic contractile element can form fixed connection points at multiple predetermined positions, so that when the valve stent 10 expands, the elastic contractile element 40 can pull the second seal 30 to form a three-dimensional structure 50.

[0058] This configuration allows the elastic contraction element 40 to form a firm connection with the first seal 20 / second seal 30 while maintaining sufficient elastic deformation capacity.

[0059] When the valve stent 10 expands, the elastic contractile element 40 contracts to its natural length. Since its two ends are fixedly connected to the first seal 20 / second seal 30, and the first seal 20 is directly attached to the outer surface of the valve stent 10, the second seal 30 only forms troughs at these connection points, while the contractile elastic contractile element 40 pulls up between the connection points to form crests, thereby forming a continuous undulating three-dimensional structure 50 in the entire circumference. This three-dimensional structure 50 has a larger surface area and stronger conformability, and can fill the concave areas of the irregular valve annulus surface, thereby providing a more comprehensive sealing effect to further prevent paravalvular leakage.

[0060] In some embodiments, the first seal 20 at least covers the third grid group 13 and the fourth grid group 14, and the coverage area of ​​the second seal 30 along the axial direction of the valve stent 10 does not exceed the coverage area of ​​the first seal 20 along the axial direction of the valve stent 10. Since the main function of the second seal 30 is to cover the sealing inlet end to protect the apex of the valve stent 10, rather than covering the entire valve stent 10, this configuration satisfies the protection requirements of critical areas while avoiding unnecessary material stacking, thus helping to maintain the overall profile dimensions of the artificial heart valve and improving its throughput performance.

[0061] like Figures 10-13 In some preferred embodiments, both the first seal 20 and the second seal 30 extend axially from the second grid group 12 to the fourth grid group 14. The elastic contraction element 40 is preferably disposed on the inner surface of the second seal 30, and its distribution area is limited to the position corresponding to the second grid group 12 and the third grid group 13 axially. The elastic contraction element 40 is not disposed in the area corresponding to the fourth grid group 14, so as to optimize the axial movement freedom of the second seal 30 at the end of the valve stent 10, so that it can effectively protect the apex of the inflow end of the valve stent 10 and prevent it from puncturing the second seal 30 or damaging the surrounding tissue.

[0062] In some embodiments, the main body portion of the elastic contraction element 40 may be selectively disposed on the surface of the first seal 20 or the second seal 30. However, regardless of which seal surface the elastic contraction element 40 is disposed on, its two ends or multiple predetermined positions along its axial length are connected to the predetermined perforations on the second seal 30 to ensure that the elastic contraction element 40 can drive the second seal 30 to form a three-dimensional structure 50.

[0063] When the elastic contraction element 40 is disposed on the surface of the second seal 30, the elastic contraction element 40 can directly drive the second seal 30 to form a three-dimensional structure 50, allowing it to directly contact the surrounding tissue, thus providing a more significant conformal effect, while avoiding interference with the structure of the first seal 20 itself. Figure 10 , Figure 11 When the elastic contractile element 40 is placed on the surface of the first seal 20, it is covered by the second seal 30 and is protected to a certain extent, reducing its friction with the surrounding tissue. At the same time, it can act more directly on the material of the second seal 30, potentially producing a more uniform three-dimensional structure 50 effect, such as... Figure 16 Both configuration methods have their advantages and can be selected according to specific clinical needs and manufacturing processes. No specific limitation is made in this embodiment. However, regardless of which configuration method is adopted, the connection between the elastic contractile element 40 and the second seal 30 should be ensured to be firm and reliable so as to ensure that they can work together to form an ideal sealing structure during the radial expansion and axial shortening of the valve stent 10.

[0064] like Figure 14 In some embodiments, the first seal 20 and the second seal 30 cooperate with each other in the area corresponding to the fourth grid group 14 to form an annular sealing cavity 31. The annular sealing cavity 31 is preferably provided with a flexible filling element. The flexible filling element can be compressed and arranged in the mesh opening of the fourth grid group 14 when the artificial heart valve is compressed and loaded into the delivery system, so as to effectively utilize the mesh opening space, reduce the radial dimension of the artificial heart valve in the compressed state, thereby improving the throughput performance of the delivery system, and slowly expand radially after release to provide a further sealing effect.

[0065] Preferably, the flexible filling element can be selected from at least one of liquid-absorbing and swelling materials, elastic membrane materials, biocompatible sponge-like materials, or fiber aggregates.

[0066] Specifically, elastic membrane materials can be thermoplastic polyurethane (TPU) films; biocompatible sponge-like materials can be chitinous porous bodies, collagen sponges, or polylactic acid-glycolic acid copolymers (PLGA); and fiber aggregates can be diene elastic fibers, polyether ester elastic fibers, or composite elastic fibers. These materials have excellent bulkiness, elasticity, and high elastic recovery rate.

[0067] Specifically, the liquid-absorbing and swelling material is preferably a bio-hydrogel, which is a three-dimensional network structure composed of hydrophilic polymer chains. This structure can absorb large amounts of water in an aqueous environment without dissolving, while maintaining structural integrity. After liquid absorption and swelling, the resulting soft elastomer can dynamically adapt to the morphological changes of surrounding tissues, providing a continuous sealing effect, especially during cardiac contraction and relaxation.

[0068] like Figure 15 In some embodiments, the outer surface of the second seal 30 is further provided with a plurality of liquid passage holes 32, which are preferably evenly or unevenly distributed along the circumference to guide blood into the annular sealing cavity 31.

[0069] When the fluid inlet 32 ​​is provided, a liquid-absorbing and expanding material is preferably placed in the annular sealing cavity 31. This arrangement ensures that after the artificial heart valve is implanted, blood can enter the annular sealing cavity 31 through the fluid inlet 32, allowing the liquid-absorbing and expanding material to absorb the blood and expand adaptively and slowly. This gradual expansion process enables the sealing system to form a more complete fit with the surrounding irregularly shaped calcified tissue, achieving a dynamic adaptive seal. This has significant clinical implications for reducing the risk of paravalvular leakage in patients with severe calcification of the valve annulus and leaflets.

[0070] In some embodiments, the degree of chemical cross-linking of the bio-hydrogel can be adjusted to achieve a controllable expansion rate and expansion ratio, thereby precisely matching clinical needs. In this embodiment, a bio-hydrogel formulation with slow expansion kinetics is preferred. By controlling the cross-linking reaction parameters, the hydrogel exhibits a gradual expansion behavior within several hours after contact with blood, allowing surrounding tissues sufficient time to adapt to the morphological changes. Simultaneously, hemodynamic parameters remain stable, avoiding the application of sudden mechanical pressure to surrounding tissues, thus preventing the induction or exacerbation of heart failure in patients. Furthermore, this slow expansion characteristic also promotes gradual adaptation and integration between the bio-hydrogel and surrounding tissues, forming a more stable long-term sealed interface. In this embodiment, the specific expansion rate and expansion ratio of the bio-hydrogel are not limited; those skilled in the art can make adaptive selections based on the actual needs of the patient and clinicians.

[0071] In some embodiments, the liquid passage holes 32 may also be arranged circumferentially on the inner surface of the first seal 20 to increase the chance of the liquid-absorbing and swelling material coming into contact with blood; preferably, the liquid passage holes 32 provided on the inner surface of the first seal 20 and the outer surface of the second seal 30 are arranged alternately in the circumferential direction to prevent blood from flowing directly between the two, thereby ensuring that the liquid-absorbing and swelling material can fully come into contact with blood and perform its function.

[0072] like Figure 16 In some embodiments, the elastic contractile element 40 is disposed on the outer surface of the first seal 20, and its multiple axial connection points are simultaneously fixed to the first seal 20 and the second seal 30. In this case, although its deformation space is limited to a certain extent, its position relative to the valve stent 10 can remain relatively stable, thus enabling the further provision of a position marking function. As described above, when the artificial heart valve is used for aortic valve replacement, the valve stent 10 is provided with three leaflet joint fixation windows 111 circumferentially for fixing the connection points of adjacent artificial leaflets. Therefore, preferably, among the multiple elastic contractile elements 40, there are three rows of elastic contractile elements 40 that correspond one-to-one axially to the three leaflet joint fixation windows 111, and at least a portion of these three rows of elastic contractile elements 40 contain radiopaque material for providing positioning marks during implantation.

[0073] By axially aligning a specific elastic contractile element 40 with the leaflet union fixation window 111 and providing it with imaging capabilities, interventional physicians are provided with a precise anatomical positioning reference point. In transcatheter aortic valve replacement, accurate circumferential positioning of the prosthetic heart valve is crucial. This configuration allows physicians to clearly identify the union point of the prosthetic leaflet under X-ray guidance and precisely align it with the union point of the native aortic valve leaflet. This structural configuration avoids obstruction of the coronary artery ostium by the prosthetic leaflet, which is particularly critical in patients with abnormal coronary artery ostium locations or highly calcified valve annulus, significantly reducing the risk of postoperative coronary artery occlusion and improving surgical safety.

[0074] Furthermore, the leaflet-joint fixation window 111 region, due to the composite fixation of two adjacent artificial leaflets and their clamping materials, already has a relatively large radial dimension, making it a key area restricting the passage of the artificial heart valve through the delivery system. In this embodiment, the elastic contractile element 40 does not need to overlap radially with the leaflet-joint fixation window 111, but provides a positioning function through axial correspondence. Therefore, it will not impose a further burden on the contour dimension of the joint window, which is conducive to maintaining the minimum radial dimension of the artificial heart valve under compression, thereby improving its ability to be delivered into the human body through the external sheath.

[0075] It should be noted that while providing a positioning marker function, the elastic contractile element 40 still retains its original contractile traction effect. After the artificial heart valve is dilated, these elastic contractile elements 40 can still effectively traction the second seal 30 and form a dense three-dimensional structure to enhance its contact area and contact pressure with surrounding tissues. This is especially suitable for conformal sealing of the valve annulus tissue of patients with special anatomical variations or complex calcified lesions. It can fill the concave areas of irregular surfaces and significantly reduce the incidence of paravalvular leakage.

[0076] In some embodiments, the elastic shrinkage element 40 containing the developing material may be made of the developing material or may be made of a composite weave of the developing material and the non-developable material, making it recognizable under imaging equipment.

[0077] Specifically, commonly used radiopaque materials may include medical tantalum wire, platinum-iridium alloy wire, or barium sulfate-containing polymers, all of which have excellent biocompatibility and radiopermeability.

[0078] Specifically, in embodiments where the elastic contractile element 40 is constructed from a composite weave of radiopaque and non-radiopaque materials, a structure in which radiopaque lines and elastomer lines are interwoven can be employed. By observing the discontinuous or patterned markings on the radiopaque portion under X-rays, not only positional information can be provided, but also directional information can be provided through specific weaving patterns. For example, spiral, cross, or dot-matrix radiopaque patterns can be designed to help physicians more intuitively determine the rotational direction and axial position of the artificial heart valve. In this embodiment, the radiopaque material composite woven with the non-radiopaque material can also be selected from medical tantalum wire, platinum-iridium alloy wire, or a polymer containing barium sulfate.

[0079] In some embodiments, when the elastic contractile element 40 is disposed on the first seal 20, the second seal 30 forming the three-dimensional structure 50 will not enter the interior of the valve stent 10 when it expands. Therefore, preferably, in the expanded state of the valve stent 10, the portion of the second seal 30 located on the outer side of the valve stent 10 has a micro-rough surface structure to promote endothelial cell attachment and growth, reduce local inflammatory response, reduce the risk of thrombosis, and provide a more durable sealing effect; the portion of the second seal 30 located on the inner side of the valve stent 10 has a smooth surface structure to prevent luminal stenosis caused by excessive proliferation of endothelial cells, thereby maintaining optimal hemodynamic performance and long-term patency.

[0080] In some embodiments, micro-rough surface structures can be achieved by roughening the material surface, such as through processes like plasma etching or chemical corrosion, to create surface microstructures with specific morphologies at the nanometer to micrometer scale. These microstructures can provide an ideal adhesion microenvironment for endothelial cells.

[0081] In some embodiments, a fibrous cluster surface can be formed on the outer second seal 30 by reserving a loose fiber structure during the weaving process. The three-dimensional spatial structure of the fiber cluster is closer to the natural structure of the extracellular matrix, which helps endothelial cells maintain their normal morphology and function and promotes a faster and more complete endothelialization process.

[0082] In some embodiments, a low-density weaving process can be used to achieve a rough surface. By reducing the weaving density of the second seal 30, the porosity is increased, forming an open network structure, thereby providing more cell migration channels and creating favorable conditions for the long-term survival and function of endothelial cells.

[0083] like Figures 17-20In some embodiments, both the first seal 20 and the second seal 30 are provided with elastic contraction elements 40. The elastic contraction element 40 provided on the first seal 20 is fixed to its outer surface and only covers the area corresponding to the second grid group 12 and the third grid group 13. The elastic contraction element 40 provided on the second seal 30 is disposed on its inner surface and only covers the area corresponding to the fourth grid group 14.

[0084] By incorporating an elastic contractile element 40 in the upper-middle region of the first sealing element 20, which typically corresponds to the aortic valve annulus and the area above it, an effective sealing structure can be formed in this region to prevent paravalvular leakage. Similarly, the elastic contractile element 40 in the lower region of the second sealing element 30 ensures a seal at the inflow end of the valve stent 10. This configuration allows the entire second sealing element 30 to form an ideal three-dimensional structure 50 axially. Furthermore, since the upper region of the second sealing element 30 is not directly fixed, its axial flexibility is maintained, allowing it to freely expand and contract during the compression and release of the valve stent 10. This effectively covers the end apex of the valve stent 10, preventing it from puncturing blood vessels or cardiac tissue, significantly improving implantation safety.

[0085] In some embodiments, the elastic contractile elements 40 disposed on the first seal 20 and the elastic contractile elements 40 disposed on the second seal 30 are axially aligned with each other. This arrangement enables the first seal 20 and the second seal 30 to form a synergistic sealing force in their respective areas, resulting in a more uniform and reinforced three-dimensional sealing structure. When the valve stent 10 expands radially, these axially aligned elastic contractile elements 40 can contract synchronously, causing the two seals to form consistent folds and protrusions at their respective positions, creating a regular three-dimensional sealing surface. This design is particularly suitable for patients with relatively regular valve annular morphology and mild to moderate calcification, providing uniform radial sealing pressure and minimizing the risk of paravalvular leakage.

[0086] In some embodiments, the elastic contractile elements 40 disposed on the first seal 20 and the elastic contractile elements 40 disposed on the second seal 30 are staggered in the axial direction to form a spatially staggered structure. This staggered configuration creates a more complex three-dimensional sealing interface, causing the first seal 20 and the second seal 30 to generate alternating sealing action points at different axial positions, forming a denser and more comprehensive sealing network. When the valve stent 10 expands, these staggered elastic contractile elements 40 generate misaligned contractile forces at different axial positions, causing the two layers of seals to form staggered folds and protrusions, creating a highly irregular but more comprehensive three-dimensional sealing surface. This structural configuration is more suitable for patients with highly irregular valve annulus morphology and severe calcification, better adapting to complex anatomical variations, filling various irregular gaps, and significantly reducing the incidence of paravalvular leakage.

[0087] like Figure 21 In some embodiments, the elastic contractile elements 40 disposed on the second seal 30 are inclined at a predetermined angle relative to the central axis of the valve stent 10. This inclination causes the contractile force generated by the elastic contractile elements 40 to not be limited to the radial direction, but to have both radial and tangential components, forming a helical contractile force vector. When the valve stent 10 expands, these inclined elastic contractile elements 40 cause the second seal 30 to form a helical or rotationally symmetrical three-dimensional structure 50, enhancing its ability to conform to irregular surfaces, which is particularly suitable for situations requiring handling complex hemodynamic environments.

[0088] In some embodiments, when multiple elastic contractile elements 40 disposed on the second seal 30 are distributed circumferentially, adjacent elastic contractile elements 40 are located in different cross-sectional planes in the axial direction, forming a stepped distribution structure. This stepped configuration further increases the complexity and adaptability of the sealing interface, allowing the second seal 30 to form circumferentially alternating sealing regions at different axial heights. When the valve stent 10 expands, these steppedly distributed elastic contractile elements 40 cause the second seal 30 to form a highly irregular but regular three-dimensional structure 50, which can adapt to complex anatomical structures while maintaining structural stability and predictability. This structural configuration is particularly suitable for situations requiring targeted solutions to sealing problems in specific areas, such as patients with severe local calcification or anatomical variations in specific areas.

[0089] Compared with existing technologies, the artificial heart valves provided in the above embodiments can effectively cope with complex calcified lesions and irregular valve annular structures, significantly reduce the risk of paravalvular leakage, and comprehensively improve the clinical efficacy and safety of transcatheter aortic valve replacement, providing a more reliable treatment option for patients with heart valve diseases.

[0090] In another embodiment of the present invention, a transcatheter heart valve replacement system is also provided, including a delivery device and the aforementioned artificial heart valve, wherein the artificial heart valve is releasably connected to the distal end of the delivery device and is preferably configured as a balloon-expandable artificial valve, suitable for transcatheter aortic valve replacement.

[0091] Because the artificial heart valve of this invention maintains compatibility with existing technologies in key parameters such as peripheral contour dimensions, stent contraction-expansion characteristics, and proximal-distal connection structure, the delivery device in this embodiment can adopt any technical solution from existing mature transcatheter valve delivery systems. The specific structural form of the delivery device does not constitute a limiting technical feature of this invention and can be selected according to clinical needs, surgical approach (such as via the femoral artery, apex, or aorta), and operator preference. The technological innovation of this invention mainly lies in the structure of the artificial heart valve itself, while the delivery device is designed with functional interoperability as its principle, ensuring seamless integration with existing clinical workflows and reducing the learning curve and clinical adoption threshold.

[0092] Although exemplary embodiments have been described herein with reference to the accompanying drawings, it should be understood that the above exemplary embodiments are merely illustrative and are not intended to limit the scope of this application. Various changes and modifications can be made therein by those skilled in the art without departing from the scope and spirit of this application. All such changes and modifications are intended to be included within the scope of this application as claimed in the appended claims.

Claims

1. An artificial heart valve, characterized in that, include: - A valve stent, the valve stent having an inflow end and an outflow end, the valve stent having a plurality of circumferentially arranged grid groups sequentially from the outflow end to the inflow end; - A first seal is applied to the outer surface of the valve stent, and the first seal covers at least two sets of mesh near the inflow end; - A second seal is disposed on the outside of the first seal; - A plurality of elastic contractile elements, the two ends of which are connected to the first seal and / or the second seal; the elastic contractile elements are configured to contract in the expanded state of the valve stent and drive the second seal to form a circumferentially continuous undulating three-dimensional structure.

2. The artificial heart valve according to claim 1, characterized in that, The elastic contractile elements are arranged in multiple rows along the circumference of the valve stent, and each row contains at least one elastic contractile element extending axially. The elastic contractile element includes an elastic strip-shaped structure configured to be in an axially stretched state when the valve stent is in a contracted state, and to contract to a non-stretched state when the valve stent is in an expanded state, thereby pulling the second seal to contract axially to form the three-dimensional structure.

3. The artificial heart valve according to claim 1, characterized in that, The valve stent includes a first grid group to an Nth grid group arranged sequentially from the outflow end to the inflow end, wherein N≥3; At least one set of non-end grid groups has a mesh size larger than that of at least one axially adjacent grid group. The non-end grid groups correspond to the position that abuts against the surrounding tissue after implantation, and the grid closest to the inflow end is suitable for matching the position below the valve annulus plane.

4. The artificial heart valve according to claim 3, characterized in that, The valve stent includes a first grid group, a second grid group, a third grid group, and a fourth grid group arranged sequentially from the outflow end to the inflow end; The third grid group corresponds to the position where it contacts the surrounding tissue after implantation, and the mesh size of the third grid group is larger than that of the second grid group and the fourth grid group.

5. The artificial heart valve according to claim 4, characterized in that, The first seal covers at least the third and fourth mesh groups, and the coverage area of ​​the second seal along the axial direction of the valve stent does not exceed the coverage area of ​​the first seal along the axial direction of the valve stent.

6. The artificial heart valve according to claim 5, characterized in that, One end of the second seal is fixed to the outside of the valve stent, and the other end is folded over from the inflow end to the inside of the valve stent and fixed; the second seal can move axially with the radial dimension change of the valve stent and always covers the inflow end.

7. The artificial heart valve according to claim 5, characterized in that, Both the first and second seals cover the second to the fourth grid groups. The elastic contraction element is disposed on the inner surface of the second seal, and its distribution area is limited to the positions corresponding to the second and third grid groups.

8. The artificial heart valve according to claim 7, characterized in that, The first seal and the second seal cooperate with each other in the corresponding area of ​​the fourth grid group to form an annular sealing cavity. A flexible filling element is provided in the annular sealing cavity. The flexible filling element is selected from at least one of liquid-absorbing and swelling materials, elastic film materials, biocompatible sponge materials, and fiber aggregates.

9. The artificial heart valve according to claim 8, characterized in that, The second seal is provided with a plurality of circumferentially distributed fluid passages, which are used to guide blood into the annular sealing cavity.

10. The artificial heart valve according to claim 5, characterized in that, The valve stent is provided with three leaflet joint fixing windows along the circumference for fixing the connection of adjacent artificial leaflets. The elastic contraction element is disposed on the outer surface of the first seal, and there are three rows of elastic contraction elements that correspond one-to-one with the three leaflet joint fixing windows in the axial direction; The elastic contractile elements corresponding to the leaflet joint fixation window axis all contain radiopaque material to provide positioning markers during implantation.

11. The artificial heart valve according to claim 10, characterized in that, The elastic contraction element corresponding axially to the leaflet-joint fixing window is configured as follows: The elastic contractile element is entirely composed of a developing material; Alternatively, the elastic contractile element may be woven from a composite of developable and non-developable materials, making it recognizable under imaging equipment.

12. The artificial heart valve according to claim 10, characterized in that, In the expanded state of the valve stent, the portion of the second seal located on the outer side of the valve stent has a micro-rough surface structure to promote endothelial cell attachment and growth; the portion of the second seal located on the inner side of the valve stent has a smooth surface structure to prevent excessive endothelial growth from affecting hemodynamic characteristics.

13. The artificial heart valve according to claim 12, characterized in that, The micro-rough surface structure is formed by at least one of the following methods: A loose fiber structure is reserved during the weaving process; Alternatively, a low-density weaving process can be used; Alternatively, the material surface can be roughened.

14. The artificial heart valve according to claim 10, characterized in that, The elastic contractile elements are respectively disposed on the first sealing element and the second sealing element; The elastic contractile element disposed on the first seal is located on its outer surface and covers only the areas corresponding to the second grid group and the third grid group; The elastic contractile element disposed on the second seal is located on its inner surface and covers only the area corresponding to the fourth grid group.

15. The artificial heart valve according to claim 14, characterized in that, The elastic contraction element disposed on the first seal and the elastic contraction element disposed on the second seal are spatially arranged in the following manner: Aligned with each other axially; Alternatively, they can be staggered along the axial direction to form a spatially staggered structure.

16. The artificial heart valve according to claim 14, characterized in that, The elastic contractile element disposed on the second seal is at least spatially configured as follows: It is inclined at a predetermined angle relative to the central axis of the valve stent; Alternatively, when multiple elastic contractile elements are distributed circumferentially, adjacent elastic contractile elements are located in different cross-sectional planes in the axial direction, forming a stepped distribution structure.

17. A transcatheter heart valve replacement system, comprising a delivery device and a releasable artificial heart valve connected to a distal end of said delivery device, characterized in that, The artificial heart valve is the artificial heart valve as described in any one of claims 1-16; the artificial heart valve is configured as a balloon-expandable artificial valve, suitable for transcatheter aortic valve replacement.

Images