Anchor structures and prostheses

Abstract

The present disclosure provides an anchoring structure and a prosthesis for anchoring a target tissue. The anchoring structure includes a conformal edge and at least two anchoring claws. The conformal edge includes a plurality of conformal units and is sequentially connected to form an integral closed figure, and each two adjacent conformal units share at least one conformal member, so that each conformal unit includes at least two conformal members spaced apart in the circumferential direction. At least two anchoring claws are respectively connected to at least two conformal units, and the anchoring claws include a first curved portion as a free end and a second curved portion connected to the conformal unit, the first curved portion and the second curved portion are smoothly transitioned and connected, the opening direction of the first curved portion deviates from the conformal unit and the opening direction of the first curved portion is opposite to the opening direction of the second curved portion. The anchoring structure has an autonomous adjustment function, and can maintain a close fit with the target tissue during the contraction or expansion of the target tissue, so as to achieve full fit between the prosthesis and the target tissue and stable anchoring of the prosthesis.

Description

Technical Field

[0001] The present disclosure relates to an anchoring structure and a prosthesis. Background Art

[0002] The human heart has four chambers: the left atrium, the left ventricle, the right atrium, and the right ventricle. The left and right atria and the left and right ventricles are separated by septa, so they are not connected to each other. There are valves (atrioventricular valves) between the atria and ventricles, which prevent blood from flowing from the atria to the ventricles but not backflowing.

[0003] The mitral valve refers to the left atrioventricular valve, also known as the "mitral valve", which is located between the left atrium and the left ventricle. It opens and closes naturally to ensure the unidirectional flow of blood from the left atrium to the left ventricle and a certain flow rate. Since the left ventricle is responsible for transporting blood throughout the body, the muscular layer of the left ventricle is more developed than that of the right ventricle, and is about three times thicker than the wall of the right ventricle. Therefore, during the beating of the heart, the morphology of the left ventricle will undergo tremendous changes. Since the mitral valve needs to ensure closure when the left ventricle contracts, it is the valve that bears the greatest pressure in the body. As the left ventricle beats, the size and shape of the mitral valve will also change significantly. Mitral valve lesions have an important impact on cardiac function and hemodynamics, and can seriously affect human health and quality of life.

[0004] In recent years, transcatheter mitral valve replacement (TMVI) has been increasingly used in the treatment of mitral valve disease. TMVI refers to the use of a transcatheter mitral valve system to compress the mitral valve prosthesis in vitro and load it into a delivery system, and then deliver it to the native mitral valve through a catheter intervention along a vascular path or through the apex of the heart to replace the diseased mitral valve and restore normal physiological function. Summary of the invention

[0005] At least one embodiment of the present disclosure provides an anchoring structure for anchoring a target tissue. The anchoring structure includes a conformal edge and at least two anchoring claws. The conformal edge includes a plurality of conformal units. The plurality of conformal units are connected in sequence to form an integral closed figure. Every two adjacent conformal units share at least one conformal member, so that each conformal unit includes at least two conformal members with a spacing in the circumferential direction of the closed figure. At least two anchoring claws are respectively connected to at least two conformal units. The anchoring claw includes a first curved portion configured as a free end and a second curved portion connected to the corresponding conformal unit, and the first curved portion and the second curved portion are connected with a smooth transition. The opening direction of the first curved portion is away from the conformal unit and the opening direction of the first curved portion is opposite to the opening direction of the second curved portion.

[0006] For example, in an anchoring structure provided by at least one embodiment of the present disclosure, the first curved portion of each anchoring claw is located between two conformal members of the corresponding conformal unit in the circumferential direction of the anchoring structure.

[0007] For example, in an anchoring structure provided by at least one embodiment of the present disclosure, the anchoring claws and / or the conformal units include a medical memory alloy material.

[0008] For example, in an anchoring structure provided in at least one embodiment of the present disclosure, the anchoring claw is S-shaped.

[0009] For example, in an anchoring structure provided in at least one embodiment of the present disclosure, the first curved portion of the anchoring claw is located on both sides of the plane where at least two conformal parts of the corresponding conformal unit are located; or the first curved portion of the anchoring claw is tangent to the plane where at least two conformal parts of the corresponding conformal unit are located and the anchoring claw is located on one side of the corresponding conformal unit.

[0010] For example, in an anchoring structure provided in at least one embodiment of the present disclosure, the conformal unit is symmetrical relative to the corresponding anchoring claw axis.

[0011] For example, in an anchoring structure provided by at least one embodiment of the present disclosure, the conformal unit further includes: at least two connecting members configured to connect at least two conformal members and cooperate with the at least two conformal members to form a closed graphic unit.

[0012] For example, in an anchoring structure provided by at least one embodiment of the present disclosure, each conformal unit is connected to an anchor claw, and each conformal unit is a hexagonal conformal unit. The hexagonal conformal unit is formed by four connectors and two conformal members, the four connectors include a first connector and a second connector that are close to and connected to the second curved portion, and a third connector and a fourth connector that are far from and connected to the second curved portion, the first connector and the second connector are respectively connected to one end of the corresponding two conformal members close to the second curved portion, and the third connector and the fourth connector are respectively connected to one end of the corresponding two conformal members that are far from the second curved portion.

[0013] For example, in an anchoring structure provided in at least one embodiment of the present disclosure, the connection point of the second curved portion on the corresponding conformal unit is the connection point of the first connecting member and the second connecting member.

[0014] For example, in an anchoring structure provided in at least one embodiment of the present disclosure, a conformal edge and a plurality of anchoring claws are integrally formed.

[0015] For example, in an anchoring structure provided in at least one embodiment of the present disclosure, the closed figure includes any one of the following: O-type, D-type, ellipse, and polygon.

[0016] For example, in an anchoring structure provided by at least one embodiment of the present disclosure, the anchoring claws and the conformal edge are configured to apply opposing forces to clamp at least a portion of the target tissue.

[0017] For example, in an anchoring structure provided by at least one embodiment of the present disclosure, the conformal edge is a grid structure including two or three conformal units in a radial direction along the closed figure.

[0018] For example, in an anchoring structure provided in at least one embodiment of the present disclosure, the first curved portion of the anchoring claw includes a first arc, a straight line along the radial direction of the first arc and parallel to the central axis of the closed figure is the first straight line, and the first arc extends to both sides of the first straight line.

[0019] For example, in an anchoring structure provided by at least one embodiment of the present disclosure, the curvature of the first curved portion is greater than the curvature of the second curved portion.

[0020] For example, in an anchoring structure provided in at least one embodiment of the present disclosure, the anchoring structure includes a plurality of anchoring claws having the same number as the conformal units, and the plurality of anchoring claws are respectively connected to corresponding conformal units and are evenly arranged along the circumference of the closed figure.

[0021] At least one embodiment of the present disclosure further provides a valve prosthesis, comprising any anchoring structure as described above, and a valve body connected to the anchoring structure. The valve body comprises a valve frame and a leaflet prosthesis fixed to the valve frame, wherein the valve frame is connected to an end of the conformal edge of the anchoring structure close to the second curved portion.

[0022] Compared with the prior art, the beneficial effects of at least one embodiment of the present disclosure include at least: in the anchoring structure of the present disclosure, the hyperbolic structure with opposite opening directions of the anchoring claws provides a stable clamping force, so that the implanted prosthesis can be fully fitted with the target tissue and the prosthesis is anchored stably. Moreover, the design has an autonomous adjustment function, which can maintain close fit with the target tissue during the contraction or expansion of the target tissue and adapt to the complex structural changes during the movement of the target tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the embodiments of the present disclosure or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present disclosure. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0024] Figure 1 A schematic diagram of implanting a prosthesis into a human body according to some embodiments of the present disclosure;

[0025] Figure 2 A schematic diagram of a partial structure of a prosthesis after implantation provided in some embodiments of the present disclosure;

[0026] Figure 3A front view of an anchoring structure provided for some embodiments of the present disclosure;

[0027] Figure 4 A top view of an anchoring structure provided for some embodiments of the present disclosure;

[0028] Figure 5 A partial stereoscopic schematic diagram of an anchoring claw and a conformal unit provided in some embodiments of the present disclosure;

[0029] Figure 6 A front view of a conformal unit provided for some embodiments of the present disclosure;

[0030] Figure 7 A side view of a conformal unit provided for some embodiments of the present disclosure;

[0031] Figure 8A-8C A schematic diagram of an anchoring structure provided for some embodiments of the present disclosure having two conformal units in a radial direction; and

[0032] Figure 9A-9B Partial schematic diagrams of anchoring structures provided in some embodiments of the present disclosure having 1.5 conformal units in the radial direction. DETAILED DESCRIPTION

[0033] The following will be combined with the drawings in the embodiments of the present disclosure to clearly and completely describe the technical solutions in the embodiments of the present disclosure. Obviously, the described embodiments are only part of the embodiments of the present disclosure, not all of the embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present disclosure.

[0034] Unless otherwise defined, all terms (including technical and scientific terms) used in the embodiments of the present disclosure have the same meanings as commonly understood by those of ordinary skill in the art to which the present disclosure belongs. It should also be understood that terms such as those defined in common dictionaries should be interpreted as having meanings consistent with their meanings in the context of the relevant technology, and should not be interpreted in an idealized or extremely formal sense, unless the embodiments of the present disclosure are explicitly defined in this way.

[0035] The words "first", "second" and similar words used in the embodiments of the present disclosure do not indicate any order, quantity or importance, but are only used to distinguish different components. Words such as "one", "an" or "the" and similar words do not indicate a quantity limitation, but indicate the existence of at least one. Similarly, words such as "include" or "comprise" and similar words mean that the elements or objects appearing before the word cover the elements or objects listed after the word and their equivalents, without excluding other elements or objects. Words such as "connect" or "connected" and similar words are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. Flowcharts are used in the embodiments of the present disclosure to illustrate the steps of the method according to the embodiments of the present disclosure. It should be understood that the previous or subsequent steps are not necessarily carried out in order. On the contrary, various steps can be processed in reverse order or simultaneously. At the same time, other operations can also be added to these processes, or one or more steps can be removed from these processes.

[0036] The inventors of the present disclosure have discovered that due to the unique morphological changes in the myocardial tissue around the mitral valve, some of the current products of technical solutions related to transcatheter mitral valve replacement have some shortcomings. For example, the anchoring structure of the implanted prosthesis merely holds the native valve tissue and has poor adaptability, resulting in the implanted prosthesis and the native mitral valve not being able to fully fit together and unstable anchoring. Moreover, the anchoring structure does not have the ability to adjust itself, resulting in a gap between the implanted prosthesis and the native mitral valve during contraction or expansion, causing paravalvular leakage, and is not adaptable to the complex structural changes during the movement of the mitral valve, resulting in a failure to achieve a good fit. In addition, not limited to the mitral valve, prostheses in the prior art that are suitable for the treatment of lesions of other heart valves (such as the aortic valve, tricuspid valve, and pulmonary valve) also face the same technical problems.

[0037] At least one embodiment of the present disclosure provides an anchoring structure for anchoring a target tissue. The anchoring structure includes a conformal edge and at least two anchoring claws. The conformal edge includes a plurality of conformal units, and the plurality of conformal units are sequentially connected to form an integral closed figure. Every two adjacent conformal units share at least one conformal member, so that each conformal unit includes at least two conformal members with a spacing in the circumferential direction of the closed figure. At least two anchoring claws are respectively connected to at least two conformal units. The anchoring claw includes a first curved portion configured as a free end and a second curved portion connected to the corresponding conformal unit, and the first curved portion and the second curved portion are smoothly transitioned and connected. The opening direction of the first curved portion is away from the conformal unit and the opening direction of the first curved portion is opposite to the opening direction of the second curved portion.

[0038] At least one embodiment of the present disclosure further provides a prosthesis including the above-mentioned anchoring structure.

[0039] In the anchoring structure of the above embodiment of the present disclosure, the hyperbolic structure with opposite opening directions of the anchoring claws can provide a stable support force, so that the implanted prosthesis can be fully fitted with the target tissue (e.g., native valve tissue), and the prosthesis is anchored stably, for example, the target tissue is native valve tissue including the native mitral valve. The anchoring structure has an autonomous adjustment function, and can maintain close fit with the target tissue during the contraction or expansion of the target tissue, and adapt to the complex structural changes during the movement of the target tissue.

[0040] The embodiments and examples of the present disclosure are described in detail below with reference to the accompanying drawings.

[0041] For the sake of clarity and conciseness of this article, the following mainly uses the target tissue being the native mitral valve as an example for explanation, but the present disclosure does not limit the type of applicable target tissue, that is, the present disclosure can also be applied to the treatment of other heart valves or other human tissue lesions. For example, the target tissue can also be the native aortic valve, native tricuspid valve or native pulmonary valve, etc., and the present disclosure does not impose any limitation or elaboration on this.

[0042] Figure 1 Schematic diagram of implanting a prosthesis into a human body according to some embodiments of the present disclosure. Figure 2 A schematic diagram of the partial structure of a prosthesis after implantation provided in some embodiments of the present disclosure.

[0043] For the convenience of description, the embodiments of the present disclosure will be Figure 1 The left atrium 300 side is marked as the upper side and the left ventricle 200 side is marked as the lower side. The upper and lower positions of the present disclosure are relative positions and will not limit the present disclosure. In addition, the embodiment of the present disclosure marks the side close to the central axis of the valve body 120 as the inner side and the side away from the central axis of the valve body 120 as the outer side.

[0044] In some embodiments of the present disclosure, the native mitral valve includes a native mitral valve ring (not shown) and native mitral valve leaflets 400. The myocardial tissue at the connection between the native mitral valve leaflets 400 and the walls of the left atrium 300 and the left ventricle 200 is the native mitral valve ring.

[0045] For example, Figure 1 and Figure 2 As shown, the prosthesis 100 includes an anchoring structure 110 and a valve body 120, and the valve body 120 is fixedly connected to the anchoring structure 110. The prosthesis 100 is delivered to the diseased native mitral valve between the left atrium 300 and the left ventricle 200 through a delivery device (e.g., a delivery catheter), and the implanted prosthesis 100 is anchored by the anchoring structure 110 of the prosthesis 100, so that the prosthesis 100 is anchored on the heart tissue to replace the function of the diseased native mitral valve.

[0046] For example, Figure 1and Figure 2 As shown, the anchoring structure 110 of the prosthesis 100 includes a conformal edge 111 and a plurality of anchoring claws 112. The plurality of conformal units of the conformal edge 111 are arranged in a circle to form a closed figure, and are configured to be close to the cardiac tissue near the native mitral valve (e.g., close to the atrial wall 310 above the native mitral valve and close to the side of the ventricular wall 210). In some examples, the conformal edge 111 has a certain deformation ability so that the closed figure formed by it matches the shape change of the native mitral valve ring. The anchoring claws 112 are configured to accommodate and grasp the native mitral valve leaflets 400, and cooperate with the conformal edge 111 to achieve the anchoring of the implanted prosthesis 100.

[0047] like Figure 1 As shown, in some examples, at least a portion of the native mitral valve leaflet 400 is accommodated between the anchoring claw 112 and the conformal edge 111, and the anchoring claw 112 and the conformal edge 111 are configured to apply relative forces to clamp the native mitral valve leaflet 400. The native mitral valve leaflet 400 is a sheet-like tissue. For example, in the circumferential direction, a small portion of the native mitral valve leaflet 400 is clamped by a plurality of anchoring claws 112 and conformal members 710 arranged at intervals. Thus, the native mitral valve leaflet 400 can be clamped by the originally nearly straight or arc-shaped sheet structure to form a wavy structure along the circumferential direction. Thus, a portion of the native mitral valve leaflet 400 is accommodated between the anchoring claw 112 and the conformal edge 111, that is, the anchoring claw 112 and the conformal edge 111 are basically located on the inner and outer sides of the native mitral valve leaflet 400, respectively. This will be described in further detail below.

[0048] Figure 3 A front view of an anchoring structure provided in some embodiments of the present disclosure, Figure 4 A top view of an anchoring structure provided for some embodiments of the present disclosure.

[0049] For example, Figure 3 and Figure 4 As shown, the valve body 120 is fixedly connected to the lower end of the conformal edge 111 of the anchoring structure 110. For example, the valve body 120 is generally cylindrical, and the valve body 120 includes a leaflet prosthesis (not shown) and a valve frame for supporting the leaflet prosthesis. The leaflet prosthesis is usually a biological tissue, such as a specially treated bovine pericardium or porcine pericardium, etc., to imitate the morphology of a healthy valve, and it can also be made of textiles to replace biological tissue. After the valve body 120 of the prosthesis 100 is implanted in the human body, it works, for example, to replace the native mitral valve.

[0050] For example, Figure 3 and Figure 4As shown, the conformal edge 111 includes a plurality of conformal units 700, and the plurality of conformal units 700 are sequentially connected along a direction, such as a circumferential direction, to form an overall closed figure. Every two adjacent conformal units 700 along the circumferential direction of the closed figure in the plurality of conformal units 700 share at least one conformal member 710. For example, Figure 3 and Figure 4 In the embodiment of the present invention, adjacent conformal units 700 share a conformal member. Each conformal unit 700 includes at least two conformal members 710 spaced apart in the circumferential direction. For example, Figure 3 and Figure 4 In the embodiment of the present invention, each conformal unit includes two conformal members. Figure 3 In the example, C1 is directed to a circumferential direction expressing a closed figure, and R1 is directed to a radial direction expressing a closed figure.

[0051] The anchoring structure formed by multiple shape-conserving units 700 connected end to end to form a circle in the present disclosure is a three-dimensional structure. Therefore, the closed figure in the present disclosure is intended to indicate that the contour shape of the three-dimensional structure surrounded by multiple shape-conserving units 700 is a closed figure. The circumferential direction of the closed figure in the present disclosure mainly refers to the direction of the path taken when multiple shape-conserving units 700 are connected end to end to form a circle. Therefore, the circumferential direction is not limited to the traditional narrow concept of the circumferential direction. The closed figure can be symmetrical or asymmetrical, regular or irregular, as long as it matches the native valve tissue, and the present disclosure does not impose any restrictions on this.

[0052] For example, the closed figure surrounded by multiple conformal units 700 can be O-shaped, D-shaped, polygonal or elliptical. In this way, the clamping force of the anchoring structure on the native mitral valve leaflets is not only very balanced, but also the stability of the anchoring structure is better. Of course, this is merely exemplary and not a limitation of the present disclosure. The radial direction of the closed figure of the present disclosure refers to the direction perpendicular to the circumference of the closed figure and along a surface of the multiple conformal units, and the radial direction is not limited to the traditional narrow concept of radial direction.

[0053] In some examples, some of the multiple conformal units 700 may have the same structure, all of the conformal units may have the same structure, or all of the conformal units may have different structures.

[0054] In some examples, every two adjacent conformal units 700 may also share more than two conformal parts. For example, every two adjacent conformal units 700 share two conformal parts. In this example, one conformal unit 700 is a convex polygon, and the other conformal unit 700 is a concave polygon. The conformal units of these two conformal units share two sides, that is, they share two conformal parts. This is merely exemplary and is not a limitation of the present disclosure, as long as every two adjacent conformal units 700 share at least part of a structural member that can provide a certain support, and the present disclosure does not limit the shape of the conformal member. For example, the conformal member may include a straight rod, or a non-straight rod structure, such as a rod of a curved, wavy, broken line, etc., which will not be exhaustively listed or repeated here. Similarly, the conformal members included in each conformal unit 700 in the circumferential direction are not limited to the two shown in the figure, but may also be three or more, as long as it can ensure that the leaflets of the sheet-like structure are clamped to form a wavy structure along the circumferential direction, which will not be repeated here.

[0055] For example, Figure 3 As shown, the anchor claw 112 includes a first curved portion 800 and a second curved portion 900. The first curved portion 800 is configured as a free end, that is, one end thereof is not connected to any structure. The second curved portion 900 is connected to the corresponding conformal unit 700. The first curved portion 800 and the second curved portion 900 are connected in a smooth transition. The opening direction of the first curved portion 800 is away from the conformal unit 700, and the opening direction of the second curved portion 900 is toward the conformal unit 700, so that the opening direction of the first curved portion 800 is opposite to the opening direction of the second curved portion 900, that is, the bending directions of the two curved portions are opposite.

[0056] The anchoring claw 112 of the above embodiment of the present disclosure has a first curved portion 800 and a second curved portion 900 with opposite bending directions. The anchoring structure 110 with the anchoring claw 112 having the hyperbolic structure has the ability to self-regulate and can adapt to the morphological changes of the native valve tissue (such as the native mitral valve) and the atrium. During both the systolic and diastolic phases of the heart, the anchoring structure 110 is conducive to ensuring the full fit between the prosthesis 100 and the native mitral valve leaflets 400 and the stable anchoring of the prosthesis 100, and can adapt to the complex structural changes during the movement of the native mitral valve.

[0057] Specifically, in the prior art, during heart contraction and relaxation, the contraction and relaxation of the native mitral valve annulus will lead to unstable anchoring of the prosthesis, causing the prosthesis to slip or shift, and will also cause a large gap between the prosthesis and the native mitral valve annulus, which can easily cause paravalvular leakage and cause great harm. In contrast, in some examples of the present disclosure, during heart contraction, that is, ventricular contraction, the native mitral valve annulus contracts, the ventricular wall 210 thickens, and at least a portion of the ventricular wall 210, such as a portion of the ventricular wall 210 on the side close to the atrial wall 310, applies an inward force to the first curved portion 800 of the anchoring claw 112, for example, the force applied is a force perpendicular to the periphery of the first curved portion 800, forming a component force in the direction of the center of the valve body 120, prompting the anchoring claw 112 to move inward. The first curved portion 800 of the anchoring claw 112 is leaning inward, which significantly improves the clamping force of the anchoring structure 110, so that the first curved portion 800 of the anchoring claw 112 can continue to maintain contact with the native mitral valve leaflet 400, so that the anchoring claw 112 is fully fitted with the native mitral valve leaflet 400 and together with two adjacent conformal parts, the native mitral valve leaflet 400 is better clamped, thereby achieving full fit between the native mitral valve leaflet 400 and the prosthesis 100 and stable anchoring of the prosthesis 100. During the diastole period, i.e., the ventricular diastole period, the native mitral valve ring expands, and the native mitral valve ring applies an outward force to the first curved portion 800 of the anchoring claw 112, i.e., the native mitral valve ring pushes the anchoring claw 112 outward, but at this time, the anchoring claw 112 can still provide a reliable clamping force with the adjustable function brought by its own structure, so that the anchoring claw 112 is fully fitted with the native mitral valve leaflet 400 and still well clamps the native mitral valve leaflet 400. As a result, the native mitral valve leaflet 400 and the prosthesis can still maintain a full fit, and the anchoring of the prosthesis 100 is stable.

[0058] Figure 5 The partial stereoscopic schematic diagram of the anchoring claw and the conforming unit provided for some embodiments of the present disclosure more clearly illustrates the matching relationship between the anchoring claw and the conforming unit.

[0059] For example, during the diastole of the heart, i.e., during the diastole of the ventricle, the native valve ring has a tendency to expand as a whole. Although the native mitral valve ring will push the anchor claws 112 outward at this time, the anchor claws 112 of the present disclosure can still provide a reliable clamping force by virtue of the adjustable function brought by its own structure. Figure 5As shown, the free end of the first curved portion 800 of the anchoring claw 112 is used as the part that interacts with the native mitral valve ring; one end of the second curved portion 900 is connected to the conformal edge 111, for example, the connection point is marked as P1. The free end of the anchoring claw 112 can be used as a force-bearing part. In addition, the anchoring claw 112 can be made of shape memory material, and at a certain temperature (for example, at body temperature), the anchoring claw 112 can have a tendency to reverse deformation. The specific principle can be described below. Since the opening directions of the first curved portion 800 and the second curved portion 900 of the anchoring claw 112 are opposite, that is, the bending directions are opposite, and there is a certain distance between the connection point P1 of the second curved portion 900 of the anchoring claw 112 and the force-bearing point of the free end, a force arm of the moment of the anchoring claw acting on the valve leaflet is formed. Therefore, the anchoring claw 112 can still maintain the prosthesis 100 and the native mitral valve leaflet 400 fully fit when the native mitral valve ring expands, so as to achieve the anchoring stability of the prosthesis 100.

[0060] It should be noted that Figure 5 to Figure 7 They are the local area schematic diagrams of the conformal unit, Figure 5 and Figure 6 A local area with different conformal units is selected for illustration, for example, Figure 5 and Figure 6 The two ends of the conformal member 710a and the different sides connected to the adjacent conformal units are shown in FIG. Figure 5 The schematic diagram of the position of the lower portion of the middle conformal edge 111 and the second curved portion 900 of the anchoring claw 112 can be understood in conjunction with the numerical markings in the accompanying drawings.

[0061] For example, the anchoring claw 112 includes but is not limited to medical memory alloy materials, such as nickel-titanium alloy, whereby the anchoring claw 112 generates a force tending to restore a predetermined shape at body temperature, and the predetermined shape is an intermediate shape between the extreme diastolic and extreme contractile shapes of the heart, that is, a shape opposite to both, so that in any shape of the heart, the anchoring claw 112 can generate a tendency to deform in the opposite direction, which is equivalent to generating a reverse restoring force, so that the anchoring claw 112 plays an adjustable function to provide a reliable clamping force. For example, the conformal unit 700 includes but is not limited to medical memory alloy materials, such as nickel-titanium alloy. This is merely exemplary and is not a limitation of the present disclosure.

[0062] In some examples, the anchor claw 112 is an S-shaped structure or an S-shaped structure.

[0063] For example, Figure 5As shown, the first curved portion 800 of the anchoring claw 112 is a circular arc located at the upper end, and the second curved portion 900 of the anchoring claw 112 is a circular arc located at the lower end. The two circular arcs extend in opposite directions, thereby cooperating with the shape-keeping member 710a to form an S-shaped "elastic clip" structure for clamping, for example, the native mitral valve leaflet 400. Moreover, for native valve tissues of different thicknesses, the anchoring claw 112 can effectively clamp, achieve stable anchoring of the prosthesis 100, prevent the prosthesis 100 from slipping or shifting, and form a stronger clamping force when the heart contracts. In addition, the arc-shaped structure of the first curved portion 800 of the anchoring claw 112 makes the free end of the anchoring claw 112 smoother, which can avoid damaging the native mitral valve and surrounding myocardial tissue.

[0064] In some examples, the arc of the upper end of the S-shaped anchoring claw 112 is smaller than the arc of the lower end. For example, the curvature of the arc of the upper end of the anchoring claw 112 is greater than the curvature of the arc of the lower end, which is conducive to the anchoring claw 112 providing a more reliable clamping force according to the lever principle.

[0065] For example, the length of the arc at the upper end of the anchor claw 112 may be smaller than the length of the arc at the lower end, which is merely exemplary and not a limitation of the present disclosure.

[0066] In other examples, the anchor claw 112 may also be an S-shaped structure with substantially identical arcs at the upper and lower ends, or the anchor claw 112 may also be an S-shaped structure with a smaller arc at the lower end than that at the upper end. The present disclosure may be freely adjusted according to actual needs and will not be elaborated here.

[0067] For example, Figure 2 and Figure 5 As shown, the native mitral valve leaflet 400 is a thin sheet of tissue, so the arc at the lower end of the anchoring claw 112 of the present invention must adapt to the native mitral valve leaflet 400 to a certain extent, so that the space provided by the arc can accommodate and grasp the native mitral valve leaflet 400, and allow the chordae tendineae 500 to connect the native mitral valve leaflet 400 and the papillary muscle 600.

[0068] In some examples, at least some of the conformal units 700 each have a corresponding anchoring claw 112. Figure 3As shown, the number of shape-keeping units 700 is the same as the number of anchoring claws 112 and corresponds one to one, that is, the multiple anchoring claws 112 are also arranged along the circumference of the closed figure, for example, they are evenly arranged along the circumference of the closed figure. The multiple anchoring claws 112 corresponding one to one with the shape-keeping units 700 can achieve multi-point anchoring along the circumference of the entire native mitral valve annulus. In addition, since the native mitral valve annulus contracts and relaxes when the heart contracts and relaxes, that is, the circumference of the native mitral valve annulus changes, its shape may also change, for example, it may switch between O-shape and D-shape, so multi-point anchoring can ensure that paravalvular leakage is completely avoided during the process of heart contraction and relaxation. This is merely exemplary and is not a limitation of the present disclosure.

[0069] In some examples, the second curved portion 900 of the anchoring claw 112 is fixedly connected to the corresponding conformal unit 700. For example, the conformal edge 111 and the plurality of anchoring claws 121 can be integrally formed, for example, the pipe is integrally formed into the anchoring structure 110 after cutting, shaping, polishing, passivation and other processes. In this way, the anchoring structure has good stability, a short manufacturing process, high manufacturing efficiency, and high manufacturing precision. For another example, the conformal edge 111 and the plurality of anchoring claws 112 are respectively formed by cutting, shaping, polishing, passivation and other processes of the pipe and then welded to form the anchoring structure 110. Of course, this is merely exemplary and is not a limitation of the present disclosure.

[0070] For example, Figure 3 to Figure 5 As shown, the first curved portion 800 of each anchoring claw 112 is located between two conformal members 710 of the corresponding conformal unit 700 in the circumferential direction of the anchoring structure, that is, the anchoring claw 112 and the conformal members 710 of the conformal unit 700 are arranged at intervals in the circumferential direction.

[0071] Therefore, in some embodiments of the present disclosure, two conforming members 710 with a certain support strength and the anchoring claws 112 between the two conforming members 710 together form three fulcrums, and at least part of the native mitral valve leaflets contained between the anchoring claws 112 and the conforming member 710 can be clamped by the originally nearly straight sheet structure to form a wavy structure along the circumferential direction, that is, the two conforming members 710 and the anchoring claws 112 between them jointly clamp the sheet structure of the native mitral valve leaflets, so as to achieve a better sealing effect, avoid the formation of paravalvular leakage between the prosthesis 100 and the native valve ring, and the native mitral valve can be directly stressed to achieve tight clamping. Moreover, this wavy clamping design, while improving the stability of the prosthesis anchoring, also minimizes the damage to the clamped native valve tissue and reduces the occurrence of related complications.

[0072] For example, compared with some existing technical solutions that use direct clamping between the anchor hook and the valve frame, the above-mentioned embodiments of the present disclosure cause less damage to the clamped native valve tissue. Moreover, the direct clamping of the existing solution will squeeze and rub the clamped native valve tissue, which is prone to complications.

[0073] For example, Figure 5 As shown, the first curved portion 800 of the anchor claw 112 may be separated from the plane where the two circumferentially adjacent conformal members 710 of the corresponding conformal unit 700 are located, and the entire anchor claw 112 is only located on one side of the corresponding conformal unit 700. For the convenience of description, this solution is recorded as the case where the d1 value of the anchor claw 112 is greater than 0 in the initial state without force, wherein the d1 value refers to the distance from the inner convex point Q1 of the first curved portion 800 of the anchor claw 112 to the plane where the two circumferentially adjacent conformal members 710 of the corresponding conformal unit 700 are located, and the inner convex point Q1 is the point on the first curved portion 800 that is closest to the plane where the two circumferentially adjacent conformal members 710 of the corresponding conformal unit 700 are located.

[0074] In addition, the first curved portion 800 of the anchor claw 112 may also be tangent to the plane where two circumferentially adjacent conformal members 710 of the corresponding conformal unit 700 are located, and the anchor claw 112 is located on one side of the corresponding conformal unit 700. For the sake of convenience, this solution is recorded as the case where the anchor claw 112 has a d1 value of 0 in the initial state without force. The definition of the d1 value is as described above and will not be repeated here.

[0075] In addition, the first curved portion 800 of the anchor claw 112 may also be located on both sides of the plane where two circumferentially adjacent conformal members 710 of the corresponding conformal unit 700 are located, that is, a portion of the first curved portion 800 passes inwardly through the conformal unit 700 and another portion of the first curved portion 800 is located outside the conformal unit 700. For the sake of convenience, this solution is recorded as the case where the anchor claw 112 has a d1 value less than 0 in the initial state without force. The definition of the d1 value is as described above and will not be repeated here.

[0076] In some embodiments of the present disclosure, the anchoring claw 112 of the anchoring structure 110 includes a first curved portion 800 and a second curved portion 900 with opposite bending directions, and the anchoring claw 112 and the conformal member 710 of the conformal unit 700 are arranged circumferentially at intervals. Therefore, whether the d1 value is less than or equal to 0, or when the d1 value is greater than 0, and whether the native mitral valve ring is contracting or expanding, the anchoring structure 110 can maintain the full fit between the prosthesis 100 and the native mitral valve leaflets 400 and the anchoring of the prosthesis 100 is stable, and at the same time, it also ensures that the native mitral valve leaflets 400 between the anchoring claw 112 and the conformal edge 111 are clamped into a wavy shape, achieving a better sealing effect, avoiding the formation of paravalvular leakage between the prosthesis 100 and the native valve ring, and the native mitral valve leaflets 400 can be directly stressed to achieve tight clamping.

[0077] For example, when the d1 value is less than 0 or equal to 0, the first curved portion 800 is closer to the inner side relative to the conformal unit 700 or the inner convex point Q1 of the first curved portion 800 is on the same plane as the two circumferentially adjacent conformal parts 710 of the corresponding conformal unit 700, and due to the unique S-shaped structure of the anchoring claw 112 itself, the free end of the anchoring claw 112 is located on the other side of the conformal part 710 to provide greater elastic force, so that the prosthesis 100 can fit more fully with the native mitral valve leaflet 400 and be firmly anchored, the native mitral valve leaflet 400 can be directly subjected to force, and the native mitral valve leaflet 400 can always be easily clamped into a wavy shape.

[0078] For example, when the d1 value is greater than 0, the first curved portion 800 is closer to the outside relative to the conformal unit 700, but the anchoring structure 110 of the present disclosure can still stably anchor the prosthesis 100 and make the native mitral valve leaflet 400 wavy. Specifically, the d1 value of the anchoring claw 112 in the initial state is greater than 0. When the heart contracts, that is, when the ventricle contracts, the ventricular wall 210 will thicken and move inward. The ventricular wall 210 squeezes the first curved portion 800 of the anchoring claw 112, pushing the first curved portion 800 inward, and the d1 value will become equal to 0 or less than 0. As a result, the native mitral valve leaflet 400 can still be wavy, achieving clamping and tightening. When the heart is in diastole, that is, when the ventricle is in diastole, the anchoring claw 112 can provide a reliable clamping force with the adjustable function brought by its unique S-shaped structure, as described above, which will not be repeated here. At this time, the ventricular wall 210 is still squeezing the first curved portion 800, so the d1 value will still be equal to 0 or less than 0, and due to the firm clamping of the anchoring claw 112 and the conforming member 710 and the tendency to restore the predetermined shape, the anchoring claw 112 is fully fitted with the native mitral valve leaflet 400 and is firmly anchored. The native mitral valve leaflet 400 can still be wavy, and no paravalvular leak will be formed between the prosthesis 100 and the native mitral valve ring.

[0079] For example, when the d1 value is greater than 0, the d1 value needs to be set within a reasonable range according to actual conditions to avoid the formation of paravalvular leak due to an excessively large d1 value.

[0080] In some examples, -5.0 mm ≤ d1 ≤ 3.0 mm. This is merely exemplary and is not a limitation of the present disclosure. For example, as long as the native mitral valve leaflet is wavy, it will not be described in detail here.

[0081] For example, Figure 2 and Figure 5 As shown, the first curved portion 800 of the anchor claw 112 includes a first arc S1, and a straight line along a radial direction of the first arc S1 and parallel to the central axis of the closed figure (or parallel to the central axis of the valve body 120) is a first straight line L1. The first arc S1 extends to both sides of the first straight line L1, that is, a part of the first arc S1 is located on the left side of L1, and another part of the first arc S1 is located on the right side of L1. Thus, for example Figure 5 The angle ɑ shown is greater than 90°, wherein the angle ɑ represents the obtuse angle between the radial direction L2 of the valve body 120 and the straight line L3, and the straight line L3 is a straight line along a radial direction of the first arc S1 and passing through the end surface of the right end of the first arc S1, such as a straight line passing through the center O and passing through the end surface of the right end of the first arc S1. In this case, when the ventricular wall 210 thickens, the force applied to the first arc S1 of the first curved portion 800 is in the lower left direction, that is, at this time, the thrust applied by the native valve ring on the first arc S1 has a component force in the direction of the central axis of the valve body 120 and a component force in the direction of the valve body 120, so that the first curved portion 800 of the anchoring claw 112 can be pushed inward, that is, the outward force applied to the first arc S1 of the first curved portion 800 when the ventricular wall 210 thickens is offset, so that the anchoring structure provides a more stable and reliable clamping force.

[0082] For example, the angle α is about 120°, which can ensure that the force applied to the first arc S1 of the first curved portion 800 by the ventricular wall 210 when thickening is directed toward the lower left direction, while also preventing damage to the ventricular wall 210 due to the angle α being too close to a right angle.

[0083] In some examples, the shape-keeping unit 700 is axially symmetrical with respect to the corresponding anchoring claw 112, so that the anchoring structure has a more balanced clamping force on the native mitral valve leaflet. This is only exemplary, and the shape-keeping unit 700 can also be an asymmetric structure, which is not limited in the present disclosure and will not be repeated here.

[0084] In some examples, the conformal unit 700 further includes: at least two connecting members configured to connect the two conformal members 710 and cooperate with the two conformal members 710 to form a closed graphic unit. This is merely exemplary and is not a limitation of the present disclosure. For example, in some other embodiments, the conformal unit 700 is a non-closed graphic unit, but the structural stability of the anchoring structure corresponding to the closed graphic unit is better than that of the anchoring structure corresponding to the non-closed graphic unit. The present disclosure can be adjusted according to actual needs.

[0085] Figure 6 A front view of a conformal unit provided for some embodiments of the present disclosure. Figure 7 A side view of a conformal unit provided for some embodiments of the present disclosure.

[0086] For example, Figure 6 and Figure 7 As shown, each conformal unit 700 is a hexagonal conformal unit, and the hexagonal conformal unit is formed by four connectors and two conformal members 710. The four connectors include a first connector 720 and a second connector 730 that are close to and connected to the second curved portion 900, and a third connector 740 and a fourth connector 750 that are far from and connected to the second curved portion 900. The first connector 720 and the second connector 730 are respectively connected to one end of the corresponding two conformal members 710 that are close to the second curved portion 900, and the third connector 740 and the fourth connector 750 are respectively connected to one end of the corresponding two conformal members 710 that are far from the second curved portion 900. For example, the two ends of the first conformal member 710a are respectively connected to the first connector 720 and the third connector 740, and the two ends of the second conformal member 710b are respectively connected to the second connector 730 and the fourth connector 750. In this way, the clamping force of the anchoring structure on the native mitral valve leaflet is not only very balanced, but also the stability of the anchoring structure is good. This is merely exemplary and is not a limitation of the present disclosure. For example, the conformal unit 700 of the present disclosure may also be a quadrilateral, a pentagon, a heptagon, etc., which will not be exhaustively listed or elaborated here.

[0087] For example, the two conformal members 710 of the conformal unit 700 that are spaced apart in the circumferential direction may be parallel to each other or may not be parallel to each other, may be connected and form an angle, or the straight lines where the two conformal members 710 are located may intersect, and the present disclosure does not impose any limitation on this.

[0088] For example, the connection point P1 of the second curved portion 900 on the corresponding conformal unit 700 is the connection point of the first connector 720 and the second connector 730. In this example, the anchoring claw 112 has better stability and a more regular anchoring structure, which is beneficial to improving the overall mechanical properties of the prosthesis. The connection point between the anchoring claw 112 and the conformal unit 700 disclosed in the present invention is not limited to this, and can also be other positions, which will not be repeated here.

[0089] In some embodiments of the present disclosure, the closed figure of the anchoring structure 110 has at least one conformal unit 700 in the radial direction.

[0090] In some embodiments of the present disclosure, the conformal edge 111 of the anchoring structure 110 is a large grid structure, and the large grid of the large grid structure is intended to indicate that the area of ​​the closed graphic unit surrounded by the conformal unit 700 is relatively large. For example, the large grid structure can be a large grid design along the radial direction, or a large grid design along the circumferential direction, or a large grid design in both the circumferential direction and the radial direction.

[0091] For example, in some examples, the conformal edge 111 is a large grid structure, so that the root of the atrial wall 310 matches with three or less conformal units 700 in the radial direction along the closed figure, so that the size and shape of the implanted prosthesis adapt to the heart rhythm. In addition, the design of the large grid structure reduces the coverage area of ​​the memory alloy, which is conducive to reducing the occurrence of related complications, and is easier to deform, so as to better adapt to the shape changes during heart rhythm. Here, the root of the atrial wall 310 refers to a part of the atrial wall 310 close to the ventricular wall 210.

[0092] For example, Figure 2 and Figure 3 As shown, in some examples of the present disclosure, there is a conformal unit in the radial direction of the anchoring structure 110 that matches the root of the atrial wall 310. In some other examples, there are two or three conformal units in the radial direction of the anchoring structure 110, which can not only maintain the large grid design of the anchoring structure, but also improve the radial support force of the anchoring structure to a certain extent.

[0093] For another example, in some other examples, the conformal edge 111 is configured as a large grid structure with a smaller number of conformal units in the circumferential direction. Of course, the number of conformal units of the conformal edge 111 in the circumferential direction can be determined according to actual conditions, for example, considering the circumferential support force of the anchoring structure in the circumferential direction, the size of the native tricuspid valve annulus, and the requirements of the heart rhythm, which will not be limited or elaborated here.

[0094] In some examples, the valve frame of the valve body 120 is configured as a large grid structure, and the technical effect of the large grid design can refer to the above description of the large grid of the conformal edge 111, which will not be repeated here. Of course, the valve frame and the conformal edge 111 of the valve body 120 can also be designed as large grid structures at the same time.

[0095] For the large mesh design of the conformal edge of the anchoring structure in the radial direction, the following is combined with Figure 8A-8C as well as Figure 9A-9B Describe in detail.

[0096] Figure 8A-8C A schematic diagram of an anchoring structure provided in some embodiments of the present disclosure having two conformal units in the radial direction, Fig. 8A is a side view of the anchoring structure. Figure 8B For Fig. 8A The corresponding top view, Figure 8C For Fig. 8A and Figure 8B The corresponding stereoscopic diagram.

[0097] In some examples, as described above, the anchoring structure 110 matches a portion of the atrial wall 310 near the ventricular wall 210 and has three or fewer conformal cells 700 in the radial direction of the closed pattern, which may be as follows: Figure 2 A matching conformal unit as shown can also be Figure 8A-8C The two matching conformal units shown may also be three matching conformal units (not shown), or 1.5 or 2.5 matching conformal units. Moreover, the sizes of the multiple conformal units in the radial direction of the closed figure may be the same or different, and the present disclosure does not limit this.

[0098] For example, Figure 8A-8C As shown, the closed figure of the anchoring structure 110 has two conformal units in the radial direction, namely, conformal unit 701 and conformal unit 702. For example, the conformal unit 701 is a concave hexagon and the conformal unit 702 is a convex quadrilateral, and the conformal unit 701 and the conformal unit 702 share one side 7a and another side 7b. This is merely exemplary and is not a limitation of the present disclosure. As long as there are two complete polygons in a radial direction of the closed figure, it can be used. Similarly, the example of the closed figure of the anchoring structure 110 having three conformal units in the radial direction can also be referred to. Figure 8A-8C , I will not go into details here.

[0099] Figure 9A-9B Partial schematic diagrams of anchoring structures provided in some embodiments of the present disclosure having 1.5 conformal units in the radial direction.

[0100] For example, the meaning of 1.5 in the above embodiment of the present disclosure means that for a large grid structure including a plurality of hollow cells, there is at least one complete cell in the first direction, and in another direction perpendicular to the first direction, the cells are not placed side by side in a one-to-one correspondence but are arranged in a staggered manner, so that there cannot be two complete areas of cells in the first direction. Therefore, this can be understood as the large grid structure having 1.5 cells in the first direction.

[0101] For example, Fig.9AAs shown, shape-preserving unit 701a, shape-preserving unit 701b and shape-preserving unit 701c are all hexagonal, shape-preserving unit 702a and shape-preserving unit 702b are all quadrilateral, for example, the vertical central axis direction of a shape-preserving unit 701a is recorded as the first direction, the closed figure has a hexagonal shape-preserving unit 701a in the first direction but does not include another corresponding quadrilateral shape-preserving unit 702a, and the adjacent shape-preserving unit 701a and shape-preserving unit 701b share a quadrilateral shape-preserving unit 702a. Therefore, Fig.9A The figure shown can be understood as an example of a closed figure of the anchoring structure 110 having 1.5 conformal units in the radial direction. Fig.9A In the example of FIG. 1 , points P1a and P1b serve as connection points between the anchor claw 112 and the conformal unit, respectively.

[0102] For example, Fig.9A Similarly, Fig. 9B The figure shown can be understood as another example of a closed figure of the anchoring structure 110 having 1.5 conformal units in the radial direction, which is similar to Fig.9A compared to, Fig. 9B The conformal units 701a, 701b and 701c in the figure are all changed into quadrilaterals. This is merely exemplary and does not limit the design method of the closed figure disclosed in the present invention. The meaning of 2.5 cells in the above embodiment of the present invention can refer to the meaning of the above 1.5 cells, which will not be repeated here. It should be noted that the meaning of 1.5 cells or 2.5 cells in the above embodiment of the present invention itself is common knowledge well known to those skilled in the art.

[0103] The design of the large grid structure of the conformal edge in the radial direction of the present disclosure is not limited to the above-mentioned embodiments, as long as the number of conformal units in the radial direction of the conformal edge 111 of the anchoring structure of the present disclosure is less (for example, less than or equal to three) to adapt to the root of the atrial wall compared to the number of units required in the radial direction of the small grid structure of the prior art. The design of the large grid structure of the conformal edge of the anchoring structure of the present disclosure can reduce the coverage area of ​​the memory alloy, which is conducive to reducing the occurrence of related complications and is more adaptable to the rhythm changes of the heart. For example, the cell size of the small grid structure in some existing technical solutions is 5mm*5mm, which corresponds to a local area. The number of cells N1 required in the radial direction is greater than the number of cells N2 required by the large grid structure of the present disclosure, and the size of some cells of the large grid structure can be larger than some cells of the small grid structure, or smaller than some cells of the small grid structure. The present disclosure does not limit this, and it can be determined according to the actual situation, and it will not be repeated here.

[0104] At least one embodiment of the present disclosure provides a prosthesis, which includes an anchoring structure and a valve body connected to the anchoring structure.

[0105] For example, Figure 2 , Figure 3 and Figure 5 As shown, the prosthesis 100 includes an anchoring structure 110 and a valve body 120, and the valve body 120 includes a valve frame and a leaflet prosthesis fixed on the valve frame. The valve frame of the valve body 120 is fixedly connected to the lower end of the conformal edge 111 of the anchoring structure 110, that is, the valve frame of the valve body 120 is fixedly connected to the conformal edge 111 at one end close to the second curved portion 900.

[0106] It should be noted that in the embodiments of the present disclosure, the specific structure and technical effects of the anchoring structure included in the prosthesis can refer to the above description of the anchoring structure 110. Thus, the technical effects of the prosthesis can also refer to the above description of the technical effects of the anchoring structure 110, which will not be repeated here.

[0107] There are a few points to note:

[0108] (1) The drawings of the embodiments of the present disclosure only relate to the structures involved in the embodiments of the present disclosure, and other structures may refer to the general design.

[0109] (2) In the absence of conflict, the embodiments of the present disclosure and the features therein may be combined with each other to obtain new embodiments.

[0110] The above description is only a specific implementation of the present disclosure, but the protection scope of the present disclosure is not limited thereto. The protection scope of the present disclosure shall be based on the protection scope of the claims.

Claims

1. An anchoring structure for anchoring a target tissue, comprising: A conformal edge, comprising a plurality of conformal units, the plurality of conformal units being sequentially connected to form an integral closed figure, and each two adjacent conformal units sharing at least one conformal member, so that each of the conformal units comprises at least two conformal members spaced apart in a circumferential direction of the closed figure; At least two anchoring claws are respectively connected to at least two of the shape-keeping units, wherein the anchoring claws include a first curved portion configured as a free end and a second curved portion connected to the corresponding shape-keeping unit, the first curved portion and the second curved portion are smoothly connected, the opening direction of the first curved portion is away from the shape-keeping unit and the opening direction of the first curved portion is opposite to the opening direction of the second curved portion; The anchoring claws and the conformal edge are configured to apply opposing forces to clamp at least a portion of the target tissue.

2. The anchoring structure according to claim 1, wherein: The first curved portion of each anchoring claw is located between the two conformal members of the corresponding conformal unit in the circumferential direction of the anchoring structure.

3. The anchoring structure according to claim 1, wherein: The anchoring claw and / or the shape-conforming unit comprises a medical memory alloy material.

4. The anchoring structure according to claim 1, wherein: The anchoring claw is S-shaped.

5. The anchoring structure according to claim 1, wherein: The first curved portion of the anchoring claw is located on both sides of the plane where at least two conformal members of the corresponding conformal unit are located; or The first curved portion of the anchoring claw is tangent to a plane where at least two conforming members of the corresponding conforming unit are located, and the anchoring claw is located at one side of the corresponding conforming unit.

6. The anchoring structure according to claim 1, wherein: The conformal unit is symmetrical relative to the corresponding anchoring claw axis.

7. The anchoring structure according to claim 1, wherein: The conformal unit further includes: at least two connecting members configured to connect at least two of the conformal members and cooperate with the at least two conformal members to form a closed graphic unit.

8. The anchoring structure according to claim 7, wherein: Each of the shape-keeping units is connected to one of the anchor claws, each of the shape-keeping units is a hexagonal shape-keeping unit, and the hexagonal shape-keeping unit is formed by four of the connecting members and two of the shape-keeping members. The four connecting members include a first connecting member and a second connecting member that are close to and connected to the second curved portion, and a third connecting member and a fourth connecting member that are far from and connected to the second curved portion. The first connecting member and the second connecting member are respectively connected to one end of the corresponding two conforming members close to the second curved portion, and the third connecting member and the fourth connecting member are respectively connected to one end of the corresponding two conforming members away from the second curved portion.

9. The anchoring structure according to claim 8, wherein: The connection point of the second curved portion on the corresponding conformal unit is the connection point of the first connecting member and the second connecting member.

10. The anchoring structure according to claim 1, wherein: The conformal edge and the anchoring claw are integrally formed.

11. The anchoring structure according to claim 1, wherein: The closed figure includes any one of the following: O-shape, D-shape, ellipse, polygon.

12. The anchoring structure according to claim 1, wherein: The conformal edge is a grid structure including two or three conformal units in a radial direction along the closed figure.

13. The anchoring structure according to claim 1, wherein: The first curved portion of the anchor claw includes a first arc, and a straight line along the radial direction of the first arc and parallel to the central axis of the closed figure is a first straight line. The first arc extends to both sides of the first straight line.

14. The anchoring structure according to claim 1, wherein: The curvature of the first curve portion is greater than the curvature of the second curve portion.

15. The anchoring structure of claim 1, wherein: The number of the anchoring claws is the same as the number of the conformal units and corresponds one to one.

16. A valve prosthesis, comprising: An anchoring structure as described in any one of claims 1 to 15, and a valve body connected to the anchoring structure, the valve body comprising a valve frame and a leaflet prosthesis fixed on the valve frame, wherein the valve frame is connected to one end of the conformal edge of the anchoring structure close to the second curved portion.

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