Valve anchor and valve system

Abstract

The application provides a valve anchor and a valve system, the valve anchor comprising an elastic wire, a containing part and a traction body; the containing part is arranged outside the elastic wire and connected with the elastic wire; the containing part is distributed along the extension direction of the elastic wire and has a cavity; the traction body is partially arranged in the cavity of the containing part, and after being wound into a closed loop at the end of the containing part corresponding to the distal end of the elastic wire, the traction body is divided into two parts, the two parts extend along the axis of the containing part in the containing part, and the two ends of the traction body extend out of the containing part at the end of the containing part corresponding to the proximal end of the elastic wire; the traction body can be pulled to control the moving direction of the distal end of the valve anchor. The application can make the valve anchor precisely surround the native valve leaflet under the cooperation of the elastic wire and the traction body, thereby simplifying the implantation step of the valve anchor and reducing the implantation difficulty.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a valve anchor and valve system. Background Technology

[0002] Transcatheter mitral valve replacement (TMVR) is a procedure that uses a catheter to deliver an artificial heart valve to the mitral valve annulus via a delivery system. The artificial valve is then released and fixed in place, replacing the original valve leaflet. Compared to traditional surgical procedures, mitral valve replacement does not require cardiopulmonary bypass, is less invasive, allows for faster patient recovery, and significantly improves postoperative hemodynamic parameters. Furthermore, compared to the apical approach, the transfemoral vein atrial septal approach is less invasive and has a wider range of recipients.

[0003] Although mitral valve replacement technology has advanced rapidly, the anchoring methods for artificial heart valves still have certain limitations. Traditional anchoring methods mainly involve designing anchoring spikes to grasp the native valve leaflet to fix the artificial heart valve, or fixing the artificial heart valve by over-sizing it. Both of these anchoring methods can easily cause damage to the native valve leaflet or compression of the native valve annulus, thus adversely affecting the patient's recovery.

[0004] Existing technologies also employ designs that separate the anchor from the artificial heart valve. For example, an artificial heart valve may consist of an anchor ring and a valve body. This design, separating the anchor ring and valve body, effectively avoids compression of the native valve annulus and is less likely to damage the native valve leaflets. It also reduces the size of each part of the delivery system, making it easier for the system to move within the body. In this method, the anchor ring and valve body are delivered separately. The process of releasing the anchor ring in the delivery system is complex. First, the system needs to release a loop structure within the ventricle to capture the end of the guide wire, forming a guide coil. Only then can the anchor ring be implanted along the guide coil. Simultaneously, a specially designed fastening device is required at the end of the anchor ring to form a closed ring structure. Furthermore, when the artificial heart valve has a waist-shaped structure (i.e., convex at both ends and concave in the middle), in order to achieve the expected anchoring effect, it is necessary to adjust the relative positions of the artificial heart valve and the anchoring ring multiple times so that the anchoring ring fits precisely into the concave part of the artificial heart valve. This increases the difficulty and complexity of the artificial heart valve implantation surgery and places high demands on the operator's skill level. At the same time, the excessively long operation time also has an adverse effect on the patient's health. Summary of the Invention

[0005] The purpose of this invention is to provide a valve anchor and valve system that, with the cooperation of an elastic wire and a traction body, enables the valve anchor to precisely surround the original valve leaflet, thereby simplifying the implantation procedure of the valve anchor and reducing the difficulty of implantation.

[0006] To achieve at least one of the above objectives, the present invention provides a valve anchor having a contracted state and an expanded state, and being able to switch between the contracted state and the expanded state;

[0007] The valve anchor includes an elastic wire, a receiving portion, and a traction body; the receiving portion is disposed outside the elastic wire and connected to the elastic wire; the receiving portion is distributed along the extension direction of the elastic wire and has a cavity;

[0008] The traction body is disposed within the cavity of the receiving portion, and after being wound into a closed loop at the distal end of the receiving portion corresponding to the elastic wire, it is divided into two parts. The two parts extend within the receiving portion along the axis of the receiving portion, and both ends of the traction body extend out of the receiving portion at the proximal end of the receiving portion corresponding to the elastic wire. The traction body can be pulled to control the direction of movement of the distal end of the valve anchor.

[0009] Optionally, the valve anchor is helical in shape and has an annular inner cavity for accommodating the artificial heart valve; the valve anchor is capable of adaptively expanding the outer contour of the artificial heart valve when subjected to stress and deformation, so as to apply an anchoring force to the artificial heart valve.

[0010] Optionally, in the expanded state, the valve anchor has an anchoring section surrounding the original leaflet, the anchoring section having at least one coil, and the valve anchor also has a gripping section axially connected to the anchoring section; the radius of curvature of the gripping section is greater than the radius of curvature of the anchoring section, so that the valve anchor moves along the cavity wall of the predetermined cavity and expands during implantation.

[0011] Optionally, the receiving portion is provided with a plurality of independently configured cavities for the traction body to pass through. After passing through one cavity, the traction body bends at the end of the receiving portion corresponding to the distal end of the elastic wire and then passes into another cavity.

[0012] Optionally, the number of traction bodies is one, and the receiving part includes two hollow tubes arranged side by side. Both hollow tubes are arranged parallel to the elastic wire. The two hollow tubes are connected to each other and / or connected to the elastic wire. Each hollow tube has a cavity, so that the two parts of the traction body are respectively inserted into the two hollow tubes.

[0013] Optionally, the number of traction bodies is two, and the receiving part includes four hollow tubes arranged sequentially along the circumference of the elastic wire. The four hollow tubes are all arranged parallel to the elastic wire, and the four hollow tubes are connected to each other and / or connected to the elastic wire. Each hollow tube has a cavity, so that the two parts of each traction body are respectively inserted into the corresponding two hollow tubes.

[0014] Optionally, the distal end of the receiving portion is sealed.

[0015] Optionally, the distal end of the receiving portion is closed and has a spherical, conical, or elliptical shape.

[0016] Optionally, the receiving portion includes a plurality of receiving structures spaced apart along the extension direction of the elastic wire, each receiving structure having at least two through holes arranged side by side along the radial direction of the elastic wire, the through holes of all the receiving structures forming at least two cavities, the traction body sequentially passing through one row of the through holes in all the receiving structures along the axis of the elastic wire, and after bending at the end of the receiving portion corresponding to the distal end of the elastic wire, sequentially passing through another row of the through holes in all the receiving structures.

[0017] To achieve the above objectives, the present invention also provides a valve system comprising an artificial heart valve and a valve anchor as described in any one of the claims, wherein the artificial heart valve is accommodated in the valve anchor.

[0018] In the valve anchor and valve system provided by the present invention, the valve anchor has a contracted state and an expanded state, and can switch between the contracted state and the expanded state; the valve anchor includes an elastic wire, a receiving portion, and a traction body; the receiving portion is disposed outside the elastic wire and connected to the elastic wire; the receiving portion is distributed along the extension direction of the elastic wire and has a cavity; the traction body is partially disposed in the cavity of the receiving portion, and after being wound into a closed loop at the end of the receiving portion corresponding to the distal end of the elastic wire, it is divided into two parts, the two parts extending along the axis of the receiving portion within the receiving portion, and both ends of the traction body protruding from the receiving portion at the end of the receiving portion corresponding to the proximal end of the elastic wire; the traction body can be pulled to control the movement direction of the distal end of the valve anchor. With this configuration, since the valve anchor is pre-shaped into a specific structure, such as a spiral structure, before implantation, it can expand and form around the native valve leaflet during gradual release. In particular, the valve anchor can control the movement direction (including the orientation of the distal end) of the valve anchor through its own traction body during expansion. This ensures that the distal end of the valve anchor can always move along the wall of the predetermined chamber (such as the ventricle). It also allows the valve anchor to remain parallel to the native valve annulus during movement without being disturbed by the periodic motion of the heart. This ensures that the valve anchor can grasp all the native valve leaflets and chordae tendineae and other native tissues after full expansion, avoiding slippage towards the apex of the heart or injury to the myocardium due to the influence of the heart's anatomy. This improves the reliability and safety of artificial heart valve surgery.

[0019] Furthermore, the valve system includes an artificial heart valve and a valve anchor, the artificial heart valve being housed within the valve anchor. With this configuration, the valve system eliminates the need for a lanyard structure to capture the guide wire, and when the valve anchor is helical, there is no need for a mating fastening device on the valve anchor. This simplifies the valve anchor implantation process, reduces the difficulty of implantation, and improves the success rate of artificial heart valve implantation, thereby reducing harm to the patient and promoting postoperative recovery.

[0020] The valve anchor preferably has an anchoring section, which connects the artificial heart valve to the anchoring section through an interference fit between the inner cavity and the artificial heart valve, and applies an anchoring force to the artificial heart valve. After the valve anchor is implanted, the traction body is removed, and the valve anchor adapts to the external contour of the artificial heart valve, thereby fixing the artificial heart valve in the predetermined object. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the valve anchor in a preferred embodiment of the present invention;

[0022] Figure 2 This is a partial structural schematic diagram of the valve anchor in another preferred embodiment of the present invention;

[0023] Figure 3 This is a schematic diagram of the valve anchor in another preferred embodiment of the present invention;

[0024] Figure 4 This is a schematic diagram of the valve anchor in another preferred embodiment of the present invention;

[0025] Figure 5 This is a schematic diagram of the initial use scenario of the valve anchor in a preferred embodiment of the present invention.

[0026] Figure 6 This is a schematic diagram illustrating a preferred embodiment of the present invention where the valve anchor moves toward the apex of the heart.

[0027] Figure 7 This is a schematic diagram of a preferred embodiment of the present invention showing a scenario in which the valve anchor surrounds the original valve leaflet.

[0028] Figure 8 This is a schematic diagram of the valve anchor and the use scenario after implantation of the artificial heart valve in a preferred embodiment of the present invention.

[0029] In the figure: valve anchor 1; elastic wire 11; receiving part 12; cavity 121; cavity tube 122; receiving structure 123; through hole 124; traction body 13; inner cavity 14; anchoring section 15; grasping section 16; original leaflet 21; chordae tendineae 22; artificial heart valve 3; outflow section 31; valve annulus section 32; flange section 33; delivery sheath 4. Detailed Implementation

[0030] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become clearer from the following description. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to facilitate and clarify the illustration of the embodiments of the present invention.

[0031] The terms “center,” “longitudinal,” “lateral,” “length,” “width,” “thickness,” “upper,” “lower,” “front,” “rear,” “left,” “right,” “vertical,” “horizontal,” “top,” “bottom,” “inner,” “outer,” “clockwise,” “counterclockwise,” “axial,” “radial,” and “circumferential” indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the present invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention.

[0032] In the description of this invention, it should be understood that the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0033] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "fixation," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection, an electrical connection, or a connection that allows communication between them; they can refer to a direct connection or a connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0034] As used in this specification, the term "proximal" generally refers to the end closer to the surgeon; the term "distal," in contrast to "proximal," generally refers to the end farther from the surgeon. As used in this specification, the term "radial" refers to the direction parallel to the native annulus after the valve anchor or valve system is implanted in the heart, i.e., the radial direction of the native annulus; the term "axial" refers to the direction perpendicular to the native annulus after the valve anchor or valve system is implanted in the heart, i.e., the axial direction of the native annulus.

[0035] The core idea of ​​this invention is to provide a valve anchor and valve system. The valve anchor can firmly anchor an artificial heart valve to the original leaflet in the heart, such as the aortic, tricuspid, or mitral valve, thereby replacing the original heart valve (aortic, tricuspid, or mitral valve). It should be understood that the heart contains four chambers: the left atrium, right ventricle, and left ventricle. During the entire cardiac cycle, the pumping action of the left and right sides of the heart generally occurs synchronously. The thin membrane separating the atria and ventricles is called the atrioventricular valve. Each atrium is connected to its corresponding atrial valve through the atrial vestibule. The atrioventricular valve acts as a one-way valve, ensuring the normal flow of blood within the heart chambers. The atrioventricular valve between the left atrium and left ventricle is the mitral valve, and the atrioventricular valve between the right atrium and right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and into the lungs; then, blood flows to the left atrium through the pulmonary veins. The aortic valve guides blood flow through the aorta to the whole body.

[0036] During ventricular filling (diastole), the aortic and pulmonary valves close to prevent blood from flowing back into the ventricles; simultaneously, the mitral and tricuspid valves open to allow blood to flow from the atria into the corresponding ventricles. During ventricular systole (emptying), the mitral and tricuspid valves close to prevent blood from flowing from the atria into the corresponding ventricles; simultaneously, the aortic and pulmonary valves open to allow blood to be pumped out of the ventricles and through the aorta and pulmonary artery to reach the whole body and lungs; then the left and right atria relax to allow peripheral blood to flow back into the left and right atria.

[0037] When the atrioventricular valves malfunction, they often fail to close properly. The atrioventricular valves typically consist of an annulus, primary leaflets, chordae tendineae, and supporting structures. The mitral valve has two primary leaflets, and the tricuspid valve has three. The contact between these leaflets allows the mitral or tricuspid valve to close or seal, preventing blood flow between the ventricles and atria during ventricular systole. Incomplete sealing between the primary leaflets of the mitral and tricuspid valves is called valvular regurgitation or malcontinence. In this case, during ventricular systole, blood in the ventricles can flow back into the corresponding atrium through the gap between the mitral or tricuspid valves. This often leads to heart failure, reduced blood flow, decreased blood pressure, and reduced oxygen levels reaching the body's tissues. Furthermore, atrioventricular regurgitation can cause blood to flow from the left atrium back into the pulmonary veins, causing pulmonary congestion. Severe atrioventricular regurgitation, if left untreated, can lead to permanent disability or death.

[0038] As in the background art, in the traditional design of separating valve anchors from artificial heart valves, the valve anchors need to rely on a rope loop structure to form a guide coil when released. Furthermore, when the anchor ring is released along the guide coil, a fastening device needs to be designed at the end of the anchor ring to form a closed ring structure. This makes the delivery process of the anchor ring delivery system complicated and increases the difficulty of implanting the valve anchors.

[0039] To address the above technical problems, this invention provides a valve anchor that eliminates the need for a lanyard structure to capture the guide wire, thus simplifying the implantation process, reducing the difficulty of implantation, and improving the reliability and convenience of artificial heart valve surgery.

[0040] The present invention will now be described in detail with reference to the accompanying drawings and preferred embodiments. Unless otherwise specified, the following embodiments and features can complement or combine with each other.

[0041] like Figure 1 and Figure 8As shown, a preferred embodiment of the present invention provides a valve anchor 1 (hereinafter referred to as valve anchor 1), the valve anchor 1 including an elastic wire 11, a receiving portion 12 and a traction body 13; the receiving portion 12 is disposed outside the elastic wire 11 and connected to the elastic wire 11; the receiving portion 12 is distributed along the entire extension direction of the elastic wire 11 and has a cavity 121, so that the shape of the receiving portion 12 corresponds to the shape of the elastic wire 11; the traction body 13 is partially disposed in the cavity 121 of the receiving portion 12, and the traction body 13 is divided into two parts after being wound into a closed loop at the end of the receiving portion 12 corresponding to the distal end of the elastic wire 11, and the closed loop at the distal end of the receiving portion 12 serves as the force application point; in addition, the two parts of the traction body 13 extend along the axis of the receiving portion 12 within the receiving portion 12, and the two ends of the traction body 13 extend out of the receiving portion 12 at the proximal end of the receiving portion 12 corresponding to the elastic wire 11 to facilitate the operator to operate the traction body 13.

[0042] The valve anchor 1 has a contracted state and an expanded state, and can switch between the contracted state and the expanded state. The traction body 13 can be pulled to control the direction of movement of the distal end of the valve anchor 1. It should be understood that the traction body 13 being wound into a closed loop at the end of the receiving portion 12 corresponding to the distal end of the elastic wire 11 means that the traction body 13 can bypass the distal end of the valve anchor 1 and be divided into two parts, and then the two parts of the traction body 13 can extend in the cavity 121. At this time, the direction of movement of the distal end of the valve anchor 1 can be controlled by pulling the two ends of the traction body 13.

[0043] In this embodiment, the traction body 13 is movably disposed in the cavity 121 of the receiving portion 12. Either end of the traction body 13 can be pulled to move the distal end of the entire valve anchor 1 in a predetermined direction, such as returning the distal end of the valve anchor 1 to its original predetermined position, thereby restoring the entire valve anchor 1 to its predetermined shape. As a preferred embodiment, under the pulling of the traction body 13, the distal end of the entire valve anchor 1 can always move along the cavity wall of the predetermined chamber, and the valve anchor 1 is closed and shaped according to the cavity wall. After the valve anchor 1 is fully expanded, the valve anchor 1 can be positioned around the original valve leaflet of the predetermined object, and the valve anchor 1 can be fixed at the original valve annulus using the artificial heart valve 3.

[0044] In this embodiment, the valve anchor 1 is spiral-shaped in the expanded state and has an annular cavity 14 for accommodating the artificial heart valve 3.

[0045] Figure 8 This illustrates an application scenario of the artificial heart valve 3 according to a specific embodiment of the present invention. See also... Figure 8After implantation, taking mitral valve replacement as an example, the artificial heart valve 3 is partially housed within the annular lumen 14. The valve anchor 1 is positioned and fixed to the mitral valve annulus through the expansion or structure of the artificial heart valve 3. Specifically, the fixing method of the valve anchor 1 is related to the structure of the artificial heart valve 3. The artificial heart valve 3 can adopt an existing structure, specifically including an interconnected outflow segment 31 and annular segment 32. In some cases, the artificial heart valve also includes a flange segment 33 to improve the anchoring effect of the artificial heart valve 3 and prevent paravalvular leakage. The outflow segment 31, annular segment 32, and flange segment 33 are axially connected sequentially, and after the artificial heart valve 3 expands, the inner diameters of the outflow segment 31 and flange segment 33 are both larger than the inner diameter of the annular segment 32. When the artificial heart valve 3 has the aforementioned structure of being convex at both ends and concave in the middle (i.e., a waist-shaped structure), the artificial heart valve 3 can expand without compressing the valve anchor 1. In this case, the valve anchor 1 is attached to the annulus segment 32 of the artificial heart valve and can be held in place by the outflow segment 31 and the flange segment 33 of the artificial heart valve 3. If the artificial heart valve 3 is cylindrical or conical, the valve anchor 1 can be compressed against the annulus through the expansion of the artificial heart valve 3. In this case, the valve anchor 1 can adapt to the external contour of the expanded artificial heart valve 3 when deformed under force, so as to apply anchoring force to the artificial heart valve 3.

[0046] For more specific reference, see Figure 1 and Figure 5 As shown, the valve anchor 1 can be placed in the delivery sheath 4 and moved with the delivery sheath 4 to the mitral valve annulus. Then, under the push of the delivery system, the valve anchor 1 can be gradually moved out of the delivery sheath 4 and released in the left ventricle. During the release process, the movement direction of the distal end of the valve anchor 1 is adjusted by pulling the traction body 13, thereby ensuring that the distal end of the valve anchor 1 always moves in a predetermined direction. Finally, under the control of the traction body 13, it is spirally wound in a predetermined direction and surrounds the original leaflet 21. Moreover, during the molding process, the orientation of the distal end of the valve anchor 1 is controlled by the traction body 13. This allows the valve anchor 1 to remain parallel to the original valve annulus without being disturbed by the periodic motion of the heart during movement. This ensures that after the valve anchor 1 is fully expanded, it can grasp all the original leaflets 21 and chordae tendineae 22 and other original tissues, avoiding slippage towards the apex of the heart or injury to the myocardium due to the influence of the heart's anatomy, thereby improving the reliability and safety of the artificial heart valve 3 surgery.

[0047] It should be understood that the predetermined object refers to the main body on which the artificial heart valve 3 needs to be implanted, and the predetermined object generally refers to the human heart. The predetermined chamber refers to a chamber in the heart that can accommodate and fix the valve anchor 1, such as the left or right ventricle of the human heart. The predetermined direction refers to the direction of movement of the valve anchor 1 that allows it to surround the original leaflet 21 without pointing towards the apex of the heart or damaging the distal end of the valve anchor 1. Preferably, the predetermined direction is along the wall of the predetermined chamber.

[0048] This invention also provides a valve system, including an artificial heart valve 3 and a valve anchor 1, wherein the artificial heart valve 3 is housed within the valve anchor 1. This valve system eliminates the need for a lanyard structure to capture the guide wire, and when the valve anchor 1 is helical, there is no need to design a fastening device for docking on the valve anchor 1. This simplifies the implantation process of the valve anchor 1, reduces the difficulty of implantation, and improves the success rate of artificial heart valve 3 implantation, thereby reducing harm to the patient.

[0049] Preferably, the outer diameter of the artificial heart valve 3 is larger than the inner diameter of the valve anchor 1. This allows the valve anchor 1 to deform under stress after the artificial heart valve 3 is implanted and expands. Since the elastic wire 11 is elastic, the valve anchor 1 can also adapt to the external contour of the artificial heart valve 3 when deformed under stress. An anchoring force can be applied to the artificial heart valve 3 through the interference fit between the valve anchor 1 and the artificial heart valve 3, thereby enabling the artificial heart valve 3 to be more firmly connected to the valve anchor 1. The valve anchor 1 can also provide an anchoring force for the artificial heart valve 3 to be anchored in the heart, so as to fix the artificial heart valve 3 at the original leaflet 21, that is, the artificial heart valve 3 is fixed in the predetermined object by the valve anchor 1.

[0050] Furthermore, the elastic wire 11 is made of an elastic material, preferably a material with shape memory function and strong elastic deformation capability, to ensure that the elastic wire 11 can undergo a large degree of elastic deformation in the axial, radial, or circumferential directions. The elastic wire 11 can be pre-shaped into a spiral shape, so that the elastic wire 11 can be stretched along the extension direction (i.e., the length direction) and placed in the delivery sheath 4. When the valve anchor 1 is released, the elastic wire 11 can return to the spiral shape during the gradual removal of the delivery sheath 4, so that the valve anchor 1 can form a spiral shape after expansion and anchor at the position of the original leaflet 21.

[0051] This application does not limit the elastic material used to prepare the elastic wire 11, as long as it is a metallic or polymeric material capable of elastic deformation. For example, the elastic wire 11 can be made of one or more of stainless steel, titanium alloy, and nickel-titanium alloy. The material of the elastic wire 11 can also be a polymeric material, such as nylon or polyester fiber. Furthermore, each elastic wire 11 can be prepared from one or more materials; for example, segments of different types of materials can be connected to form the elastic wire 11. The elastic wire 11 can be a solid or hollow structure, as long as it can provide sufficient support. At the same time, the cross-sectional shape of the elastic wire 11 is not limited; it can be circular, annular, or rectangular, or it can be a variable diameter or variable cross-section design, meaning that the cross-sectional size or shape of the elastic wire 11 is different at different locations to meet the design requirements of the valve anchor 1.

[0052] This application does not limit the material used to prepare the traction body 13; the traction body 13 only needs to be able to be stretched and bent. The traction body 13 in this application can be made of metal wire, metal tube, or polymer wire, for example, it can be made of one or more combinations of stainless steel wire, titanium alloy wire, and nickel-titanium alloy wire. To allow the traction body 13 to adapt to the size of the cavity 121 of the receiving part 12, the diameter of the traction body 13 can be set to 0.1 mm to 1.5 mm to facilitate the movement of the traction body 13 within the cavity 121 of the receiving part 12.

[0053] Furthermore, the accommodating portion 12 is provided with multiple independently configured cavities 121 through which the traction body 13 passes (see...). Figure 1 A traction element 13 passes through one cavity 121, bends at the distal end of the receiving portion 12 corresponding to the elastic wire 11, and then passes into another cavity 121. Specifically, refer to... Figure 1 As shown, each cavity 121 is a continuous cavity. The traction body 13 can enter through the proximal end of one cavity 121 of the receiving portion 12 and exit through the distal end of that cavity 121. Then, the traction body 13 bends at the end of the receiving portion 12 corresponding to the distal end of the elastic wire 11 and enters through the distal end of another cavity 121 and exits through the proximal end of the other cavity 121. It should be understood that the proximal end of the cavity 121 corresponds to the proximal end of the elastic wire 11, so that the proximal end of the receiving portion 12 is close to the proximal end of the elastic wire 11; the distal end of the cavity 121 corresponds to the distal end of the elastic wire 11, so that the distal end of the receiving portion 12 is close to the distal end of the elastic wire 11. With this configuration, when the valve anchor 1 begins to release (e.g....), Figure 5 ), and the distal end of the valve anchor 1 moves away from the predetermined direction and slides toward the apex of the heart (e.g. Figure 6When the valve anchor 1 is in its original position, the operator can pull both ends of the traction body 13 to bend the distal end of the valve anchor 1 towards the proximal end and return it to its original position. This restores the entire valve anchor 1 to its original spiral shape and allows it to continue moving along the wall of the predetermined chamber (e.g., Figure 7 This allows for multiple controls on the movement direction of the distal end of the valve anchor 1 during its release, until the valve anchor 1 surrounds the original leaflet 21. After the valve anchor 1 is implanted, the traction body 13 can be withdrawn to fix the valve anchor 1 in the position of the original valve annulus, thus completing the implantation of the valve anchor 1. It should be noted that because the elastic wire 11 in the valve anchor 1 has shape memory function, the valve anchor 1 can automatically return to its predetermined spiral shape after expansion. When the distal end of the valve anchor 1 moves towards the apex of the heart, pulling the two ends of the traction body 12 can bend the distal end of the valve anchor 1 and return it to its original predetermined position, thereby allowing the valve anchor 1 to continue moving along the cavity wall of the predetermined chamber.

[0054] In some embodiments, see Figure 1 and Figure 2 The number of traction bodies 13 is one. The accommodating part 12 includes two hollow tubes 122 arranged side by side. Both hollow tubes 122 are arranged parallel to the elastic wire 11. Each hollow tube 122 has a cavity 121 so that the two parts of the traction body 13 are respectively inserted into the two hollow tubes 122. In one embodiment, the two hollow tubes 122 can be connected to the elastic wire 11 respectively. For example, the two hollow tubes 122 can be arranged on both sides of the elastic wire 11. In another embodiment, the two hollow tubes 122 are connected to each other, and only one hollow tube 122 is connected to the elastic wire 11. For example, the elastic wire 11 and one hollow tube 122 can be arranged on both sides of the other hollow tube 122. See reference. Figure 1 As shown, in this embodiment, each hollow tube 122 is connected to the elastic wire 11 and another hollow tube 122, respectively, that is, the elastic wire 11 and the two hollow tubes 122 form a triangular-like structure (see reference). Figure 1 The structure of the elastic wire 11 and the hollow tube 122 reduces the cross-sectional size of the valve anchor 1, facilitating delivery by the delivery system. In this document, the delivery system refers to the delivery system for the valve anchor 1 or the artificial heart valve 3, that is, a device capable of carrying the compressed valve anchor 1 or the artificial heart valve 3 within a predetermined object (e.g., the human heart).

[0055] This application does not limit the material used to prepare the hollow tube 122. For example, the hollow tube 122 may be made of a low-strength polymer material, such as polyethylene, PU, ​​or polytetrafluoroethylene.

[0056] In this embodiment, the elastic wire 11 and the hollow tube 122 are of the same length, and the elastic wire 11 and the hollow tube 122 are positioned correspondingly and can be connected at the contact position by sewing, bonding or other means.

[0057] In other embodiments, the receiving part 12 may also include only a cavity tube 122. In this case, the cavity tube 122 is provided with a cavity 121 through which the traction body 13 passes. After the traction body 13 forms a closed loop at the distal end of the valve anchor 1 (for example, after the traction body 13 passes through the two round holes at the distal end of the valve anchor 1), it enters the cavity 12 of the cavity tube 122.

[0058] Reference Figure 3 As shown, in other embodiments, the number of traction bodies 13 is two, and the receiving portion 12 includes four hollow tubes 122 arranged sequentially along the elastic wire 11. All four hollow tubes 122 are parallel to the elastic wire 11, and each hollow tube 122 has a cavity 121, so that the two parts of each traction body 13 are respectively inserted into the corresponding two hollow tubes 122. In one embodiment, the four hollow tubes 122 can be connected to each other to form a square-like structure before being connected to the elastic wire 11, in which case only two hollow tubes 122 are connected to the elastic wire 11. In another embodiment, all four hollow tubes 122 can be connected to the elastic wire 11 and an adjacent hollow tube 122, in which case the four hollow tubes 122 can be connected to each other to form a square-like structure, and the elastic wire 11 is inserted into the square structure (see reference). Figure 3 (The structure of the elastic wire 11 and the hollow tube 122). Therefore, this application does not limit the placement of the elastic wire 11 and the elastic tube 15. It should be understood that in the above-mentioned two or four hollow tubes 122, the material, size and stiffness of each hollow tube 122 can be the same or different. It is preferred that they are the same, so as to facilitate the traction body 13 to better control the distal end of the hollow tube 122.

[0059] Preferably, when there are four cavity tubes 122 and two traction bodies 13, the two parts of each traction body 13 can be wound into a closed loop at the distal end of the receiving portion 12 corresponding to the elastic wire 11 and pass through different cavities 121. In one embodiment, the two traction bodies 13 can be arranged crosswise at the distal end of the valve anchor 1 (see reference). Figure 3 At this point, the two parts of each traction body 13, after being wound into a closed loop, can respectively pass through the cavities 121 of the two hollow tubes 122 symmetrically arranged along the axial direction of the elastic wire 11. With this configuration, when the valve anchor 1 begins to release (e.g....), Figure 5 And the distal end of valve anchor 1 moves away from the predetermined direction and slides toward the apex of the heart (e.g.) Figure 6When the valve anchor 1 is in operation, the operator can fix one traction body 13 and pull both ends of another traction body 13. Pulling different traction bodies 13 can move the distal end of the valve anchor 1 in different directions, thereby enabling the traction body 13 to control the movement of the distal end of the valve anchor 1 more directionally. Specifically, pulling different traction bodies 13 can move the distal end of the valve anchor 1 in a predetermined direction away from the atrium or in a predetermined direction closer to the atrium, so that the distal end of the valve anchor 1 can move more accurately to the predetermined position and continue to move along the cavity wall of the predetermined chamber.

[0060] In another embodiment, two traction bodies 13 can be arranged parallel to each other at the distal end of the valve anchor 1. In this case, the two parts of each traction body 13 after being wound into a closed loop can pass through the cavity 121 of the adjacent cavity tube 122 respectively. At this time, the operator can fix one of the traction bodies 13 and pull the two ends of the other traction body 13, so that the distal end of the valve anchor 1 can be moved to the predetermined position and the distal end of the valve anchor 1 can continue to move along the cavity wall of the predetermined cavity.

[0061] Preferably, the distal end of the receiving portion 12 is sealed, which facilitates the movement of the traction body 13 within the cavity 121, reduces the resistance to the traction body 13 entering or exiting the delivery system, and also reduces the risk of thrombosis at the distal end of the valve anchor 1. In this embodiment, referring to... Figure 2 As shown, all cavity tubes 122 have distal sealing arrangements that contact the predetermined chamber. For example, a silicone gasket can be placed at the distal end of the cavity 121 to seal the distal end of the valve anchor 1.

[0062] More preferably, the distal end of the receiving portion 12 is closed and has a spherical, conical, or elliptical shape. This arrangement can reduce the risk of thrombosis caused by the implantation of the valve anchor 1, and can also allow the distal end of the valve anchor 1 to transition smoothly, so as to prevent the distal end of the valve anchor 1 from scratching the myocardial wall or the apex of the heart.

[0063] Reference Figure 4As shown, in some embodiments, the receiving portion 12 includes a plurality of receiving structures 123 spaced apart along the extension direction of the elastic wire 11. Each receiving structure 123 has at least two through holes 124 arranged radially side by side along the elastic wire 11. The through holes 124 of all receiving structures 123 form at least two cavities 121. The traction body 13 passes sequentially through a corresponding row of through holes 124 in all receiving structures 123 along the axis of the elastic wire 11, and then bends at the distal end of the receiving portion 12 corresponding to the elastic wire 11 before sequentially passing through another corresponding row of through holes 124 in all receiving structures 123. In this embodiment, each receiving structure 123 includes two interconnected rings, each of which is connected to the elastic wire 11. Each ring has a through hole 124. The traction body 13 passes sequentially through a corresponding row of through holes 124 in all rings, and then bends at the distal end corresponding to the elastic wire 11 before sequentially passing through another corresponding row of through holes 124 in all rings, thereby reducing the risk of thrombosis that may be caused by the cavity tube 122. In other embodiments, the two rings of each receiving structure 123 may also be separated and connected to the elastic wire 11 respectively. The receiving structure 123 is not limited to rings; the receiving structure 123 only needs to include two through holes 124 arranged side by side. This application does not limit the specific structure of the receiving structure 123.

[0064] This application does not limit the number of receiving structures 123; the number of receiving structures 123 can be set as needed. To better control the distal end of the valve anchor 1, the spacing between the receiving structures 123 at the distal end of the valve anchor 1 can be reduced, or the wall thickness of the receiving structures 123 at the distal end of the valve anchor 1 can be increased. This application does not limit the connection method between the receiving structure 123 and the elastic wire 11; the receiving structure 123 can be connected to the elastic wire 11 by welding, sewing, or bonding.

[0065] Please continue reading. Figure 1 In the expanded state, the valve anchor 1 has an anchoring section 15 surrounding the original leaflet 21. The anchoring section 15 has at least one coil, the number of turns being the number of turns wound when the anchoring section 15 is pre-shaped. Preferably, it has two turns, so that the anchoring section 15 can have sufficient anchoring force for the artificial heart valve 3, and can deform to adapt to the external contour of the artificial heart valve 3 when the artificial heart valve 3 expands, thereby achieving anchoring of the artificial heart valve 3 through the valve anchor 1.

[0066] To ensure that the valve anchor 1 can surround the native leaflet 21, the inner diameter of the anchoring segment 15 (i.e., the maximum diameter of the inner cavity 14 in the valve anchor 1) typically corresponds to the size of the native leaflet 21. For example, in this embodiment, the radius of the inner contour of the anchoring segment 15 is 5mm to 20mm, and a suitable valve anchor 1 can be selected according to different patients. This application does not limit the shape of the anchoring segment 15, but preferably, the shape of the outer contour of the expanded anchoring segment 15 corresponds to the inner contour of the native leaflet 21 to achieve better anchoring. For example, the expanded shape of the anchoring segment 15 can be circular, arc-shaped, or elliptical, etc.

[0067] In one embodiment, the anchoring segment 15 may be formed by winding an elastic wire 11 of one material and a hollow tube 122 of one material. In another embodiment, the anchoring segment 15 may also be formed by connecting segments of elastic wire 11 of two or more materials and hollow tubes 122 of two or more materials. For example, elastic wires 11 of different types of materials may be connected to each other, hollow tubes 122 of different types of materials may be connected to each other, and then the elastic wires 11 and hollow tubes 122 may be connected radially to form the anchoring segment 15.

[0068] To increase the frictional force during anchoring of the anchoring segment 15, thereby further enhancing the anchoring effect of the valve anchor 1 within the heart, a high-friction coefficient coating can be applied to the surface of the anchoring segment 15. The high-friction coefficient coating can be one or more combinations of polyethylene and PET materials.

[0069] Reference Figure 1 and Figure 5 As shown, in the expanded state, the valve anchor 1 preferably also has a gripping section 16 axially connected to the anchoring section 15. The radius of curvature of the gripping section 16 is larger than that of the anchoring section 15, so that the valve anchor 1 can move and expand along the wall of the predetermined chamber when implanted. Due to the larger radius of the gripping section 16, when the valve anchor 1 is released in the delivery sheath 4, the gripping section 16 can always be in close contact with the wall of the predetermined chamber, so that the valve anchor 1 can grip all the original leaflets 21 and chordae tendineae 22 and other original tissues, and will contain the original leaflets 21 and chordae tendineae 22 and other original tissues inside the lumen 14 (i.e., surrounding all the original leaflets 21 and chordae tendineae 22) when the valve anchor 1 moves, so as to ensure that the artificial heart valve 3 can be in close contact with the original leaflets 21 after implantation. It should be noted that when the valve anchor 1 passes through the middle of the chordae tendineae 22, that is, when the valve anchor 1 fails to contain the original leaflet 21 and the chordae tendineae 22 in the lumen 14, because part of the chordae tendineae 22 tissue is located outside the valve anchor 1, the artificial heart valve 3 cannot be tightly attached to part of the original leaflet 21 after implantation, which may lead to paravalvular leakage and may cause the failure of the artificial heart valve 3 surgery.

[0070] Of course, if the traction body 13 has sufficient strength, for example, by using a material with high stiffness to prepare the traction body 13 or increasing the wall thickness of the material used to prepare the traction body 13, the radius of curvature of each part of the anchoring segment 15 can be increased so that the anchoring segment 15 can move along the cavity wall of the predetermined chamber after release. After the valve anchor 1 is fully implanted, the traction body 13 is withdrawn, and the anchoring segment 15 can automatically return to the coil structure with a smaller radius of curvature as in the predetermined shape and closely adhere to the original leaflet 21. At this time, the valve anchor 1 can adapt to the external contour of the artificial heart valve 3 and provide anchoring force to the artificial heart valve 3. With this setting, the valve anchor 1 can reduce the initial radius of curvature of the grasping segment 16, or make the radius of curvature of the grasping segment 16 the same as that of the anchoring segment 15. In this case, after the valve anchor 1 is implanted, the grasping segment 16 will not float inside the predetermined chamber, which is beneficial for the long-term implantation of the valve anchor 1 in the human body.

[0071] To ensure that the grasping segment 16 always moves along the wall of the predetermined chamber during movement, the radius of curvature of the grasping segment 16 usually corresponds to the size of the predetermined chamber. That is, the radius of the outer contour of the grasping segment 16 after expansion corresponds to the radius of the inner contour of the predetermined chamber. The appropriate valve anchor 1 can be selected according to different patients, so that the valve anchor 1 can move closely against the wall of the predetermined chamber without easily inserting into the myocardial wall.

[0072] This application does not limit the shape of the gripping segment 16; the gripping segment 16 can be an arc structure or a coil structure. When the gripping segment 16 is an arc structure, it can be composed of a single arc or multiple arc segments connected together, and the length of the arc can be set as needed. The radius of curvature of each arc segment in the multiple arc segments constituting the gripping segment 16 is 10mm to 30mm to better assist the valve anchor 1 in gripping all the original leaflets 21 and chordae tendineae 22, etc. When the gripping segment 16 is a coil structure, the number of turns in the coil structure does not exceed 2 turns, so that the gripping segment 16 can be easily deformed and its direction of movement changed under the pulling of the traction body 13.

[0073] To reduce friction during the movement of the gripping section 16, i.e., to further reduce resistance during the movement of the gripping section 16, a low-friction coefficient coating can be applied to the surface of the gripping section 16. The low-friction coefficient coating can be one or more of polytetrafluoroethylene (PTFE) or velvet fabric.

[0074] In one example, different elastic wires 11 and hollow tubes 122 can be used to make the anchoring section 15 and the gripping section 16 respectively, and the anchoring section 15 and the gripping section 16 can be connected to each other to form the valve anchor 1. That is, the anchoring section 15 and the gripping section 16 are made separately and then connected to each other. In other examples, a single elastic wire 11 and a single hollow tube 122 connected to each other can be wound successively to form the anchoring section 15 and the gripping section 16 to form an integral valve anchor 1.

[0075] In a non-limiting embodiment, taking mitral valve replacement as an example, the implantation process of the valve anchor 1 and the artificial heart valve 3 is as follows:

[0076] Reference Figures 5-8 As shown, the valve anchor 1 is retracted within the delivery sheath 4, which can enter the left ventricle via the aorta, atrium, or other pathways. The valve anchor 1 is then pushed to the sheath orifice of the delivery sheath 4, and release of the valve anchor 1 begins within the left ventricle. First, the gripping segment 16 of the valve anchor 1 is pushed out from the delivery sheath 4. Due to the large radius of curvature of the gripping segment 16 after pre-forming the valve anchor 1, the gripping segment 16 can advance along the ventricular wall as it moves within the ventricle. For example... Figure 6 As shown, when the valve anchor 1 is disturbed by the movement of the ventricular wall or when the distal end of the valve anchor 1 enters the longitudinal gap of the myocardium, the distal end of the valve anchor 1 may slide towards the apex of the heart. At this time, the advancement of the valve anchor 1 is stopped, and the distal end of the valve anchor 1 is disengaged from the myocardial wall and returned to its predetermined position by pulling the two ends of the traction body 13. The distal end of the valve anchor 1 is then aligned parallel to the original valve annulus so that the distal end of the valve anchor 1 can continue to move along the wall of the predetermined chamber. Then the valve anchor 1 is advanced again. During the release of the valve anchor 1, if the distal end of the valve anchor 1 moves towards the apex again, the traction body 13 can be pulled again to adjust the direction of movement of the distal end of the valve anchor 1. This operation is repeated until the valve anchor 1 can surround all the original leaflets 21 and chordae tendineae 22 and other original tissues. Once it is confirmed that the valve anchor 1 has completely detached from the delivery sheath 4 and is able to surround the native leaflet 21, the delivery system maintains the position of the valve anchor 1 and begins the implantation of the artificial heart valve 3.

[0077] The artificial heart valve is used to replace and substitute for the natural mitral valve. The artificial heart valve 3 can enter the atrium via the inferior vena cava or other pathways, and cross the native leaflet 21 to enter the lumen 14 of the valve anchor 1. The artificial heart valve 3 can be expanded in diameter using a balloon in a single procedure or by self-expanding sheath retraction. During this expansion, the anchoring segment 15 in the valve anchor 1 undergoes elastic or plastic deformation. When deformed, the anchoring segment 15 adapts to the shape of the annulus segment 32 in the artificial heart valve 3, and is fully and securely connected to and sealed with the annulus segment 32, thereby fixing the valve anchor 1 and the artificial heart valve 3 into a single unit. The anchoring segment 15 can apply an anchoring force to the expanded artificial heart valve 3 to achieve anchoring of the artificial heart valve 3 at the location of the native leaflet 21.

[0078] like Figure 8 As shown, taking a waist-shaped artificial heart valve 3 as an example, the artificial heart valve 3 includes an outflow segment 31, a valve annulus segment 32, and a flange segment 33 connected axially in sequence. After the artificial heart valve 3 expands, the inner diameters of the outflow segment 31 and the flange segment 33 are both larger than the inner diameter of the valve annulus segment 32. After the valve anchor 1 and the artificial heart valve 3 are implanted, the implantation positions of the valve anchor 1 and the artificial heart valve 3 need to be adjusted so that the valve anchor 1 is located at the position of the valve annulus segment 32 of the artificial heart valve 3, and the valve anchor 1 surrounds and abuts the original leaflet 21. At this time, the expanded artificial heart valve 3 can provide anchoring force to the valve anchor 1 within the predetermined object. At the same time, the outflow segment 31 and the flange segment 33, with their larger radii, can limit the axial movement of the valve annulus segment 32 of the artificial heart valve 3, so that the valve annulus segment 32 can only be located at the position of the valve anchor 1, thereby ensuring that the artificial heart valve 3 cannot move axially after implantation. After the artificial heart valve 3 is fully expanded, the operator can remove the traction body 13 and withdraw the delivery system after confirming that the artificial heart valve 3 and the valve anchor 1 have been firmly implanted in the predetermined position, thereby completing the implantation surgery of the artificial heart valve 3 and the valve anchor 1.

[0079] It should also be understood that the valve system provided in the embodiments of the present invention may include the valve anchor 1 provided in any embodiment.

[0080] In summary, the valve anchor 1 and valve system provided by this invention allow the valve anchor 1, with its elastic wire 11, to be gradually expanded and, after expansion, to surround the original valve leaflet. During expansion, the valve anchor 1 can also adjust the movement direction of its distal end via the traction body 13. This ensures that the valve anchor 1 always moves along the wall of the predetermined chamber and remains parallel to the original valve annulus without being disturbed by the periodic motion of the heart. This guarantees that after full expansion, the valve anchor 1 can grasp all the original valve leaflet 21 and chordae tendineae 22, preventing it from slipping towards the apex or puncturing the myocardium due to cardiac anatomy, thus improving the reliability and safety of the artificial heart valve 3 surgery. Furthermore, this valve system eliminates the need for a lanyard structure to capture the guide wire, simplifying the implantation process of the valve anchor 1, reducing its difficulty, and increasing the success rate of artificial heart valve 3 implantation. This reduces harm to the patient and facilitates postoperative recovery.

[0081] The valve anchor 1 provided by the present invention includes an anchoring section 15. The anchoring section 15 can achieve the connection between the artificial heart valve 3 and the anchoring section 15 through an interference fit between the inner cavity 14 and the artificial heart valve 3, and apply an anchoring force to the artificial heart valve 3. After the valve anchor 1 is implanted, the traction body 13 is removed, and the valve anchor 1 can adapt to the external contour of the artificial heart valve 3, thereby allowing the artificial heart valve 3 to be fixed in the predetermined object by the valve anchor 1.

[0082] The above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A valve anchor, comprising: The valve anchor has a contracted state and an expanded state, and can switch between the contracted state and the expanded state; The valve anchor includes an elastic wire, a receiving portion, and a traction body; the receiving portion is disposed outside the elastic wire and connected to the elastic wire; the receiving portion is distributed along the extension direction of the elastic wire and has a cavity; The traction body is disposed in the cavity of the receiving part, and after being wound into a closed loop at the end of the receiving part corresponding to the distal end of the elastic wire, it is divided into two parts. The two parts extend along the axis of the receiving part, and the two ends of the traction body extend out of the receiving part at the end of the receiving part corresponding to the proximal end of the elastic wire. One of the traction bodies passes through one of the cavities, bends at its distal end corresponding to the distal end of the elastic wire in the receiving portion, and then passes into another cavity; the traction body can be pulled to control the direction of movement of the distal end of the valve anchor.

2. The valve anchor of claim 1, wherein, The valve anchor is helical in shape and has an annular inner cavity for accommodating the artificial heart valve; the valve anchor is capable of adaptively expanding the outer contour of the artificial heart valve when subjected to stress and deformation, so as to apply anchoring force to the artificial heart valve.

3. The valve anchor of claim 2, wherein, In the expanded state, the valve anchor has an anchoring section surrounding the original leaflet, the anchoring section having at least one coil, and the valve anchor also has a gripping section axially connected to the anchoring section; the radius of curvature of the gripping section is greater than the radius of curvature of the anchoring section, so that the valve anchor moves along the cavity wall of the predetermined cavity and expands during implantation.

4. The valve anchor of any of claims 1-3, wherein, The accommodating part is provided with a plurality of independently configured cavities for the traction body to pass through.

5. The valve anchor of claim 4, wherein, The number of traction bodies is one, and the receiving part includes two hollow tubes arranged side by side. Both hollow tubes are arranged parallel to the elastic wire. The two hollow tubes are connected to each other and / or connected to the elastic wire. Each hollow tube has a cavity, so that the two parts of the traction body are respectively inserted into the two hollow tubes.

6. The valve anchor of claim 4, wherein, The number of traction bodies is two. The accommodating part includes four hollow tubes arranged sequentially along the circumference of the elastic wire. The four hollow tubes are all arranged parallel to the elastic wire. The four hollow tubes are connected to each other and / or connected to the elastic wire. Each hollow tube has a cavity, so that the two parts of each traction body are respectively inserted into the corresponding two hollow tubes.

7. The valve anchor of claim 4, wherein, The distal end of the receiving portion is sealed.

8. The valve anchor of claim 7, wherein, The distal end of the receiving portion is closed and has a spherical, conical, or elliptical shape.

9. The valve anchor of claim 4, wherein, The receiving portion includes a plurality of receiving structures spaced apart along the extension direction of the elastic wire. Each receiving structure has at least two through holes arranged side by side along the radial direction of the elastic wire. The through holes of all the receiving structures form at least two cavities. After the traction body passes through one row of the through holes in all the receiving structures in sequence along the axis of the elastic wire, it bends at the end of the receiving portion corresponding to the distal end of the elastic wire and then passes through another row of the through holes in all the receiving structures in sequence.

10. A valve system characterized by, It includes an artificial heart valve and a valve anchor as described in any one of claims 1-9, wherein the artificial heart valve is used to be housed in the valve anchor.

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