CN117045394A

CN117045394A - Valve anchor and valve system

Info

Publication number: CN117045394A
Application number: CN202210487351.4A
Authority: CN
Inventors: 何东; 马康玲; 刘祥; 魏勇强
Original assignee: Jiangsu Zhenyi Medical Technology Co ltd; Shanghai Zhenyi Medical Technology Co ltd
Current assignee: Jiangsu Zhenyi Medical Technology Co ltd; Shanghai Zhenyi Medical Technology Co ltd
Priority date: 2022-05-06
Filing date: 2022-05-06
Publication date: 2023-11-14
Also published as: WO2023213107A1

Abstract

The invention provides a valve anchor and a valve system, wherein the valve anchor comprises an elastic wire, a containing part and a traction body; the accommodating part is arranged outside the elastic wire and is connected with the elastic wire; the accommodating parts are distributed along the extending direction of the elastic wires and are provided with cavities; the traction body part is arranged in the cavity of the accommodating part, is divided into two parts after the end part of the accommodating part corresponding to the distal end of the elastic wire is wound into a closed loop, extends along the axis of the accommodating part in the accommodating part, and extends out of the accommodating part at the end part of the accommodating part corresponding to the proximal end of the elastic wire; the traction body can be pulled to control the direction of movement of the distal end of the valve anchor. According to the invention, the valve anchor can accurately encircle the native valve leaflet under the cooperation of the elastic wire and the traction body, so that the implantation step of the valve anchor is simplified, and the implantation difficulty is reduced.

Description

Valve anchor and valve system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a valve anchoring piece and a valve system.

Background

Transcatheter mitral valve replacement surgery (TMVR) is a method of using a catheter to intervene, compressing a prosthetic heart valve in vitro to a delivery system, delivering the prosthetic heart valve to the mitral valve annulus of a human body, and releasing and fixing the prosthetic heart valve at the mitral valve annulus to replace native valve leaflets. Compared with the surgical operation, the mitral valve replacement operation does not need an external circulation auxiliary device, has small wound and quick recovery of patients, can obviously improve the hemodynamic index of the postoperative patients, has smaller wound when being implanted through the atrial septum path of the femoral vein relative to the apical path, and has wider audience.

Although mitral valve replacement techniques have evolved rapidly, there are still limitations to the manner in which prosthetic heart valves can be anchored. Traditional anchoring methods are mainly to fix the prosthetic heart valve by designing anchoring thorns to grasp native valve leaflets or by over-sizing the prosthetic heart valve. Both of these anchoring means are prone to damage to the native valve leaflet or compression of the native annulus tissue, thereby adversely affecting patient recovery.

The prior art also adopts the design that an anchoring piece is separated from a prosthetic heart valve, for example, the prosthetic heart valve is composed of an anchoring ring and a valve main body, the design that the anchoring ring is separated from the valve main body can effectively avoid the compression of a native valve ring, the native valve leaflet is not easy to damage, and meanwhile, the size of each part of a conveying system is reduced, so that the movement of the conveying system in a body is facilitated. In this manner, the anchoring ring is delivered separately from the valve body. Wherein the process of releasing the anchoring ring by the anchoring ring delivery system is complicated, firstly the anchoring ring delivery system needs to release the rope loop structure in the heart to catch the end of the guide wire so that the guide wire forms a guide coil, and then the anchoring ring can be implanted along the guide coil. At the same time, the end of the anchoring ring is also specially designed with a butt-joint fastening device, so that the anchoring ring has a closed ring structure. In addition, when the artificial heart valve is in a kidney-shaped structure (i.e., convex at both ends and concave in the middle), in order to achieve the desired anchoring effect, the mutual positions of the artificial heart valve and the anchoring ring need to be adjusted multiple times, so that the anchoring ring is just clamped into the concave of the artificial heart valve, the difficulty and complexity of the implantation operation of the artificial heart valve are increased, the operation proficiency of an operator is high, and meanwhile, the health of a patient is adversely affected due to the overlong operation time.

Disclosure of Invention

The invention aims to provide a valve anchoring piece and a valve system, which can enable the valve anchoring piece to accurately encircle a primary valve leaflet under the cooperation of an elastic wire and a traction body, so that the implantation step of the valve anchoring piece can be simplified, and the implantation difficulty is reduced.

To achieve at least one of the above objects, the present invention provides a valve anchor having a contracted state and an expanded state, and being switchable between the contracted state and the expanded state;

the valve anchoring piece comprises an elastic wire, a containing part and a traction body; the accommodating part is arranged outside the elastic wire and is connected with the elastic wire; the accommodating parts are distributed along the extending direction of the elastic wires and are provided with cavities;

the traction body part is arranged in the cavity of the accommodating part, is divided into two parts after the end part of the accommodating part corresponding to the distal end of the elastic wire is wound into a closed loop, extends along the axis of the accommodating part in the accommodating part, and extends out of the accommodating part at the end part of the accommodating part corresponding to the proximal end of the elastic wire; the traction body can be pulled to control the direction of movement of the distal end of the valve anchor.

Optionally, the valve anchor is spiral in shape and has an annular lumen for receiving a prosthetic heart valve; the valve anchor is capable of adapting to the outer contour of the expanded prosthetic heart valve upon deformation under force to apply an anchoring force to the prosthetic heart valve.

Optionally, in the expanded state, the valve anchor has an anchor segment surrounding the native valve She Yong, the anchor segment having at least one turn of a coil, the valve anchor further having a grasping segment axially connected to the anchor segment; the radius of curvature of the grabbing section is larger than that of the anchoring section, so that the valve anchoring piece moves along the cavity wall of the preset cavity when being implanted and expands and forms.

Optionally, a plurality of cavities which are independently arranged and used for the traction body to penetrate are arranged in the accommodating part, one traction body penetrates through one cavity and then penetrates into the other cavity after bending at the end part of the accommodating part corresponding to the far end of the elastic wire.

Optionally, the number of the traction body is one, the accommodating part includes two cavity pipes arranged side by side, two cavity pipes are all arranged in parallel with the elastic wire, two cavity pipes are connected with each other and/or with the elastic wire, and each cavity pipe is provided with one cavity, so that two parts of one traction body are respectively penetrated in the two cavity pipes.

Optionally, the number of the traction body is two, the holding portion includes four cavity pipes that distribute in proper order along the elastic wire circumference, four cavity pipes all with the elastic wire parallel arrangement, four cavity pipes interconnect and/or with the elastic wire is connected, every cavity pipe has one the cavity, so that every two parts of the traction body wear to establish respectively in two corresponding cavity pipes.

Optionally, the distal end of the receiving portion is sealingly disposed.

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

Optionally, the holding portion includes along a plurality of holding structures of extending direction interval arrangement of elastic yarn, every holding structure has at least two edges the radial through-hole that sets up side by side of elastic yarn, all holding structure the through-hole constitutes at least two the cavity, the traction body is followed the axis of elastic yarn passes in proper order all behind the through-hole of one row in the holding structure after the holding portion corresponds the tip bending of the distal end of elastic yarn is followed in proper order and is penetrated in all the holding structure another row in the through-hole again.

To achieve the above object, the present invention also provides a valve system comprising a prosthetic heart valve for being received in the valve anchor, and any one of the valve anchors.

In the valve anchors and valve systems provided herein, the valve anchors have a contracted state and an expanded state, and are switchable between the contracted state and the expanded state; the valve anchoring piece comprises an elastic wire, a containing part and a traction body; the accommodating part is arranged outside the elastic wire and is connected with the elastic wire; the accommodating parts are distributed along the extending direction of the elastic wires and are provided with cavities; the traction body part is arranged in the cavity of the accommodating part, is divided into two parts after the end part of the accommodating part corresponding to the distal end of the elastic wire is wound into a closed loop, extends along the axis of the accommodating part in the accommodating part, and extends out of the accommodating part at the end part of the accommodating part corresponding to the proximal end of the elastic wire; the traction body can be pulled to control the direction of movement of the distal end of the valve anchor. When configured in this way, since the valve anchor is pre-shaped into a specific structure, such as a spiral structure, the valve anchor can be expanded and molded around the native valve leaflet when gradually released, and particularly, the valve anchor can also control the moving direction (including the direction of the distal end) of the distal end of the valve anchor by a traction body during the expansion process, so that the distal end of the valve anchor can be ensured to always move along the cavity wall of a predetermined cavity (such as a ventricle), and the valve anchor can be ensured to be always parallel to the native valve annulus without being interfered by the periodical motion of the heart when moving, thereby ensuring that the valve anchor can grasp all the native tissues such as the native valve leaflet and chordae after being fully expanded, avoiding the influence of the heart anatomy to slide to the apex direction or stab the cardiac muscle, and further improving the reliability and safety of the artificial heart valve operation.

Further, the valve system includes a prosthetic heart valve for receipt in the valve anchor and a valve anchor. When so configured, the valve system does not need a rope loop structure to capture the guide wire, and when the valve anchor is in a spiral shape, a butt-joint fastening device is not required to be designed on the valve anchor, so that the implantation process of the valve anchor can be simplified, the implantation difficulty of the valve anchor can be reduced, the success rate of implantation of the artificial heart valve can be improved, and further, the damage to a patient can be reduced, and the postoperative rehabilitation of the patient is facilitated.

The valve anchor preferably has an anchor section which can be connected to the anchor section by an interference fit between the lumen and the prosthetic heart valve and which exerts an anchoring force on the prosthetic heart valve. After implantation of the valve anchor, the retractor is withdrawn and the valve anchor can adapt to the outer contour of the prosthetic heart valve, thereby allowing the prosthetic heart valve to be secured in the intended subject by the valve anchor.

Drawings

FIG. 1 is a schematic structural view of a valve anchor in a preferred embodiment of the present invention;

FIG. 2 is a schematic view of a partial structure of a valve anchor in another preferred embodiment of the present invention;

FIG. 3 is a schematic structural view of a valve anchor in another preferred embodiment of the present invention;

FIG. 4 is a schematic structural view of a valve anchor in another preferred embodiment of the present invention;

FIG. 5 is a schematic view of the use scenario of a valve anchor in an initial release phase in accordance with a preferred embodiment of the present invention;

FIG. 6 is a schematic view of the use of the valve anchor of a preferred embodiment of the present invention moving in the apical direction;

FIG. 7 is a schematic view of the use of a valve anchor surrounding a native leaflet in a preferred embodiment of the present invention;

fig. 8 is a schematic view of the valve anchor and prosthetic heart valve in a preferred embodiment of the present invention in use after implantation.

In the figure: a valve anchor 1; an elastic thread 11; a housing portion 12; a cavity 121; a cavity tube 122; a receiving structure 123; a through hole 124; a traction body 13; a lumen 14; an anchor section 15; a gripping section 16; native valve leaflets 21; chordae tendineae 22; a prosthetic heart valve 3; an outflow section 31; an annulus segment 32; a flange section 33; a delivery sheath 4.

Detailed Description

The invention is described in further detail below with reference to the drawings and the specific examples. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention.

The terms "center," "longitudinal," "transverse," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counter-clockwise," "axial," "radial," "circumferential," etc. refer to an orientation or positional relationship based on that shown in the drawings, merely for convenience of description and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the invention.

In the description of the present invention, it should be understood that the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present invention, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.

In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and include, for example, either fixedly attached, detachably attached, or integrally formed; may be mechanically connected, may be electrically connected or may be in communication with each other; either directly, or through an intermediary, may be internal to the two elements or in an interactive relationship with the two elements, unless explicitly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

As used in this specification, the term "proximal" generally refers to the end that is proximal to the operator; the term "distal" is opposite "proximal" and generally refers to the end that is distal from the operator. As used in this specification, the term "radial" refers to a direction parallel to the native annulus, i.e., radial of the native annulus, after implantation of the valve anchor or valve system into the heart; the term "axial" refers to the direction perpendicular to the native annulus, i.e., the axial direction of the native annulus, after implantation of the valve anchor or valve system in the heart.

The core idea of the present invention is to provide a valve anchor by means of which a prosthetic heart valve can be firmly anchored to a native valve She Chu in the heart, such as at the aortic, tricuspid or mitral valve, thereby replacing the original heart valve (aortic, tricuspid or mitral valve). It is understood that the heart contains four chambers, namely, the left atrium, right ventricle, right atrium, and left ventricle. The pumping action on the left and right sides of the heart generally occurs simultaneously throughout the cardiac cycle. The membranes separating the atria from the ventricles are called atrioventricular valves, each connected to a respective atrioventricular valve by an atrioventricular vestibule, which function as a one-way valve, i.e. ensure the normal flow of blood in the heart chamber. Wherein the atrioventricular valve between the left atrium and the left ventricle is the mitral valve and the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and flows the blood to the lungs; and then blood flows through the pulmonary veins to the left atrium. The aortic valve directs blood flow through the aorta to the whole body.

During ventricular filling (diastole), the aortic and pulmonary valves are closed to prevent backflow of blood in the arteries back into the ventricles; while the mitral and tricuspid valves open to allow blood to pass from the atria into the corresponding ventricles. During ventricular systole (evacuation), the mitral and tricuspid valves close to prevent blood from the atria from entering the respective ventricles; while the aortic and pulmonary valves open to allow blood to be pumped from the ventricles and through the aortic and pulmonary arteries to the whole body and lungs; and then the left and right atria are dilated to return peripheral blood to the left and right atria.

When the atrioventricular valve is in a problem, the atrioventricular valve is often not closed normally. Since the atrioventricular valve generally comprises an annulus, native leaflets, chordae tendineae and a support structure. Wherein the mitral valve has two native leaflets and the tricuspid valve has three native leaflets, and abutment between each of the native leaflets enables the mitral or tricuspid valve to close or seal, thereby preventing blood flow between the ventricle and the atrium during ventricular systole. Failure to fully seal between the native leaflets of the mitral and tricuspid valves, known as heart valve insufficiency or malacia, when, during ventricular systole, blood in the ventricles can flow back through the gaps between the mitral or tricuspid valves to the respective atria, which tends to result in heart failure, reduced blood flow, reduced blood pressure, and reduced oxygen content of the blood to the various tissues of the human body in the patient, and atrioventricular valve insufficiency may also cause blood to flow back from the left atrium to the pulmonary veins, causing congestion in the lungs; severe atrioventricular valve insufficiency can lead to permanent disability or death of the patient if left untreated.

As background art, in the design that the conventional valve anchor is separated from the prosthetic heart valve, the valve anchor needs to rely on a rope loop structure to form a guide wire into a guide loop when released, and a fastening device needs to be designed at the end of an anchor ring to form a closed loop structure when the anchor ring is released along the guide loop, which can lead to complex conveying process of an anchor ring conveying system and increase implantation difficulty of the valve anchor.

In order to solve the technical problems, the invention provides the valve anchor, which does not need a rope sleeve structure to capture the guide wire, so that the implantation process of the valve anchor can be simplified, the implantation difficulty of the valve anchor is reduced, and the reliability and convenience of the artificial heart valve operation can be further improved.

The invention will be described in detail below with reference to the drawings and the preferred embodiments. The following embodiments and features of the embodiments may be complemented or combined with each other without conflict.

As shown in fig. 1 and 8, a preferred embodiment of the present invention provides a valve anchor 1 (hereinafter referred to as a valve anchor 1), the valve anchor 1 including an elastic wire 11, a receiving portion 12, and a traction body 13; the accommodating part 12 is arranged outside the elastic wire 11 and is connected with the elastic wire 11; the accommodating parts 12 are distributed along the whole extending direction of the elastic wire 11 and are provided with cavities 121, so that the shape of the accommodating parts 12 corresponds to the shape of the elastic wire 11; the traction body 13 is partially arranged in the cavity 121 of the accommodating part 12, the traction body 13 is divided into two parts after being wound into a closed loop at the end part of the accommodating part 12 corresponding to the distal end of the elastic wire 11, and the closed loop is formed at the distal end part of the accommodating part 12 to serve as a force application point; in addition, two parts of the traction body 13 extend along the axis of the accommodating portion 12 in the accommodating portion 12, and both ends of the traction body 13 extend out of the accommodating portion 12 at the end portion of the accommodating portion 12 corresponding to the proximal end of the elastic wire 11 to facilitate the operation of the traction body 13 by an operator.

The valve anchor 1 has a contracted state and an expanded state, and is switchable 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 fact that the traction body 13 is wound in 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, in which case the moving direction of the distal end of the valve anchor 1 can be controlled by pulling the two ends of the traction body 13.

In this embodiment, the traction body 13 is movably arranged in the cavity 121 of the receiving portion 12, and 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 to return the distal end of the valve anchor 1 to a position at the time of initial presetting, thereby returning the entire valve anchor 1 to the shape at the time of presetting. As a preferred embodiment, the distal end of the entire valve anchor 1 can be moved all along the wall of the predetermined chamber under the pulling of the pulling body 13, and the valve anchor 1 is folded and shaped in the shape of the wall. After the valve anchor 1 is fully expanded, the valve anchor 1 can be positioned around the native valve leaflets of the predetermined subject, and the valve anchor 1 can be secured at the native annulus using the prosthetic heart valve 3.

In this embodiment, the valve anchor 1 is spiral in shape in the expanded state and has an annular lumen 14 for receiving the prosthetic heart valve 3.

Fig. 8 illustrates an application scenario of the prosthetic heart valve 3 according to an embodiment of the present invention. Referring to fig. 8, after implantation in the body, for example a mitral valve replacement, the prosthetic heart valve 3 is partially received in the annular lumen 14 and the valve anchor 1 is positioned and secured at the mitral valve annulus by expansion or configuration of the prosthetic heart valve 3. In particular, the manner in which the valve anchor 1 is secured is related to the structure of the prosthetic heart valve 3. The prosthetic heart valve 3 may take on existing construction and in particular may comprise an outflow section 31 and an annular section 32 connected to each other, and in some cases a flange section 33 to enhance the anchoring effect of the prosthetic heart valve 3 and to prevent paravalvular leakage. The outflow section 31, the annular section 32 and the flange section 33 are axially connected in sequence, and after the artificial heart valve 3 is expanded, the inner diameters of the outflow section 31 and the flange section 33 are both larger than the inner diameter of the annular section 32. When the artificial heart valve 3 is in the structure with the convex middle concave (i.e. the kidney-shaped structure), the artificial heart valve 3 can not compress the valve anchoring member 1 when being expanded, and the valve anchoring member 1 is abutted against the annular segment 32 of the artificial heart valve and can be clamped in the concave part through the outflow segment 31 and the flange segment 33 of the artificial heart valve 3. If the prosthetic heart valve 3 is cylindrical or conical, the valve anchor 1 can be pressed against the annulus by expansion of the prosthetic heart valve 3, at which time the valve anchor 1 can adapt to the outer contour of the expanded prosthetic heart valve 3 when deformed under force to exert an anchoring force on the prosthetic heart valve 3.

As shown in more detail with reference to fig. 1 and 5, the valve anchor 1 may be placed in the delivery sheath 4 and moved with the delivery sheath 4 to the mitral valve annulus position, after which the valve anchor 1 may be gradually moved out of the delivery sheath 4 and released in the left ventricle under the pushing of the delivery system, the valve anchor 1 may be moved in a predetermined direction throughout the release by pulling the traction body 13 to adjust the direction of movement of the distal end of the valve anchor 1, thereby ensuring that the distal end of the valve anchor 1 is always moved in the predetermined direction, and finally spiral-wound in the predetermined direction under the control of the traction body 13 and around the native valve leaflet 21. In addition, in the molding process, the traction body 13 controls the direction of the distal end of the valve anchoring member 1, so that the valve anchoring member 1 can be always parallel to the native valve annulus without being interfered by the periodical motion of the heart when moving, thereby ensuring that the valve anchoring member 1 can grasp all native tissues such as the native valve leaflet 21, the chordae tendineae 22 and the like after being fully expanded, avoiding sliding towards the apex direction or stabbing the cardiac muscle under the influence of the heart anatomy structure, and further improving the reliability and safety of the operation of the artificial heart valve 3.

It is to be understood that the predetermined object refers to a body in which the prosthetic heart valve 3 is to be implanted, the predetermined object generally referring to the heart of a human body. The predetermined chamber refers to a chamber in the heart that can accommodate and fix the valve anchor 1, e.g. the predetermined chamber refers to the left or right ventricle of the human body. The predetermined direction refers to a moving direction of the distal end of the valve anchor 1 which enables the valve anchor 1 to encircle the native valve leaflet 21 without pointing toward the apex of the heart or damaging the myocardial wall, and preferably, the predetermined direction is a direction along the wall of the predetermined chamber.

Embodiments of the present invention also provide a valve system comprising a prosthetic heart valve 3 and a valve anchor 1, the prosthetic heart valve 3 being for accommodation in the valve anchor 1. The valve system does not need a rope sleeve structure to capture the guide wire, and a butt-joint fastening device is not required to be designed on the valve anchoring piece 1 when the valve anchoring piece 1 is in a spiral shape, so that the implantation process of the valve anchoring piece 1 can be simplified, the implantation difficulty of the valve anchoring piece 1 can be reduced, the implantation success rate of the artificial heart valve 3 can be improved, and the injury to a patient can be reduced.

Preferably, the outer diameter of the prosthetic heart valve 3 is larger than the inner diameter of the valve anchor 1, so that after implantation of the prosthetic heart valve 3, the valve anchor 1 can be deformed under stress after expansion of the prosthetic heart valve 3, and the elastic wire 11 has elasticity, so that the valve anchor 1 can adapt to the outer contour of the prosthetic heart valve 3 under stress deformation, and can apply anchoring force to the prosthetic heart valve 3 through interference fit between the valve anchor 1 and the prosthetic heart valve 3, thereby enabling the prosthetic heart valve 3 to be connected with the valve anchor 1 more firmly, and can also provide anchoring force for anchoring the prosthetic heart valve 3 in the heart through the valve anchor 1, so that the prosthetic heart valve 3 is fixed at the native valve 21 even if the prosthetic heart valve 3 is fixed in a predetermined object through the valve anchor 1.

Further, the elastic wire 11 is made of an elastic material, preferably a material having a shape memory function and a strong elastic deformability, so as to ensure that the elastic wire 11 can be elastically deformed to a large extent in the axial, radial or circumferential directions. The elastic yarn 11 may be previously shaped into a spiral shape, so that the elastic yarn 11 may be stretched in the extending direction (i.e., the length direction) and placed in the delivery sheath 4. Upon release of the valve anchor 1, the elastic wire 11 may revert to a spiral shape during gradual removal of the delivery sheath 4, so that the valve anchor 1, after expansion, can form a spiral shape and anchor in place of the native leaflets 21.

The elastic material for producing the elastic yarn 11 is not limited in the present application, and any elastic material may be used as long as it is a metal material or a polymer material capable of elastically deforming. For example, the elastic wire 11 may be made of one or a combination of stainless steel, titanium alloy and nickel-titanium alloy, and the material of the elastic wire 11 may also be made of a polymer material, such as nylon material, polyester fiber, and the like. Furthermore, each elastic filament 11 may be made from a combination of one or more materials, for example, segments of different kinds of materials may be interconnected to form the elastic filament 11. The elastic wire 11 may be a solid or hollow structure as long as it can provide a sufficiently strong supporting force. Meanwhile, the cross-sectional shape of the elastic wire 11 is not limited, such as a round shape, a ring shape or a rectangular shape, or may be a design with a variable diameter or a variable cross section, that is, the cross sections of the elastic wire 11 at different positions are different in size or shape, so as to meet the design requirements of the valve anchoring member 1.

The application is not limited to the material from which the traction body 13 is made, and the traction body 13 only needs to be capable of stretching and bending. The traction body 13 in the present application may be provided as a metal wire, a metal tube, a high polymer wire, or the like, and the traction body 13 may be provided as one or a combination of a plurality of stainless steel wires, titanium alloy wires, nickel-titanium alloy wires, or the like, for example. To enable the traction body 13 to adapt to the size of the cavity 121 of the receiving portion 12, the diameter of the traction body 13 may be set to 0.1mm to 1.5mm to facilitate movement of the traction body 13 in the cavity 121 of the receiving portion 12.

Further, a plurality of cavities 121 (see fig. 1) are provided in the accommodating portion 12, in which the traction body 13 is disposed in a penetrating manner, and one traction body 13 penetrates into the other cavity 121 after passing through one cavity 121, and bends at the end of the accommodating portion 12 corresponding to the distal end of the elastic wire 11. Specifically, referring to fig. 1, each cavity 121 is a continuous cavity, and the traction body 13 can penetrate into the proximal end of one cavity 121 of the accommodating portion 12 and penetrate out from the distal end of the cavity 121, and then the traction body 13 penetrates into the distal end of the other cavity 121 and penetrates out from the proximal end of the other cavity 121 after the end of the accommodating portion 12 corresponding to the distal end of the elastic wire 11 is bent. It should be appreciated that the proximal end of the cavity 121 corresponds to the proximal end of the elastic wire 11, such 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, with the distal end of the receiving portion 12 being close to the distal end of the elastic wire 11. So configured, when the valve anchor 1 begins to release (fig. 5), and the distal end of the valve anchor 1 moves away from the predetermined direction and slides toward the apex of the heart (fig. 6), the operator can pull on both ends of the traction body 13 to bend the distal end of the valve anchor 1 proximally and return to the position at the time of initial presetting, thereby returning the entire valve anchor 1 to the spiral shape at the time of presetting and continuing to move in the cavity wall direction of the predetermined chamber (fig. 7), so that the moving direction of the distal end of the valve anchor 1 can be controlled multiple times during the release of the valve anchor 1 until the valve anchor 1 is made to encircle the native valve leaflet 21. And after implantation of the valve anchor 1, the traction body 13 can be withdrawn to fix the valve anchor 1 in position in the native annulus, thereby completing implantation of the valve anchor 1. Since the elastic wire 11 in the valve anchor 1 has a shape memory function, the valve anchor 1 can automatically return to a spiral shape at the time of predetermined shape after expansion. When the distal end of the valve anchor 1 is moved in the apical direction, pulling on the two ends of the traction body 12 can bend the distal end of the valve anchor 1 and return to the position when initially pre-set, thereby enabling the valve anchor 1 to continue to move in the direction of the lumen wall of the predetermined chamber.

In some embodiments, referring to fig. 1 and 2, the number of the traction bodies 13 is one, the accommodating portion 12 includes two cavity tubes 122 disposed side by side, and the two cavity tubes 122 are disposed parallel to the elastic wire 11, and each cavity tube 122 has one cavity 121, so that two portions of one traction body 13 respectively pass through the two cavity tubes 122. In an embodiment, two cavity tubes 122 may be connected to the elastic wire 11, respectively, for example, two cavity tubes 122 may be disposed at both sides of the elastic wire 11. In another embodiment, two cavity tubes 122 are connected to each other, and only one cavity tube 122 is connected to the elastic wire 11, for example, the elastic wire 11 and one cavity tube 122 may be disposed on both sides of the other cavity tube 122. Referring to fig. 1, in the present embodiment, each cavity tube 122 is connected to the elastic wire 11 and the other cavity tube 122, respectively, that is, the elastic wire 11 and the two cavity tubes 122 form a triangle-like structure (refer to the structure of the elastic wire 11 and the cavity tubes 122 in fig. 1), so that the cross-sectional size of the valve anchor 1 can be reduced to facilitate the delivery of the delivery system. Herein, the delivery system refers to a delivery system of the valve anchor 1 or the prosthetic heart valve 3, i.e. refers to a device capable of carrying the compressed valve anchor 1 or prosthetic heart valve 3 for movement within a predetermined object, such as a human heart.

The material of the cavity tube 122 is not limited in the present application. For example, the hollow tube 122 may be made of a relatively low-strength polymer material, such as polyethylene, PU, polytetrafluoroethylene, or the like.

In this embodiment, the lengths of the elastic wire 11 and the hollow tube 122 are the same, and the positions of the elastic wire 11 and the hollow tube 122 correspond to each other and can be sewn, adhered or connected in other ways at the contact positions.

In other embodiments, the accommodating portion 12 may also include only one cavity tube 122, where a cavity 121 through which the traction body 13 passes is disposed in the cavity tube 122, and the traction body 13 enters the cavity 12 of the cavity tube 122 after the distal end of the valve anchor 1 forms a closed loop (for example, after the traction body 13 passes through two circular holes at the distal end of the valve anchor 1).

Referring to fig. 3, in other embodiments, the number of the traction bodies 13 is two, the accommodating portion 12 includes four cavity tubes 122 sequentially distributed along the elastic wire 11, the four cavity tubes 122 are all disposed parallel to the elastic wire 11, and each cavity tube 122 has one cavity 121, so that two portions of each traction body 13 respectively pass through the corresponding two cavity tubes 122. In one embodiment, four cavity tubes 122 may be connected to each other to form a square-like structure and then connected to the elastic wire 11, where only two cavity tubes 122 are connected to the elastic wire 11. In another embodiment, four cavity tubes 122 may be connected to the elastic wire 11 and an adjacent cavity tube 122, where the four cavity tubes 122 may be connected to each other to form a square-like structure, and then the elastic wire 11 may be inserted into the square-like structure (refer to the structure of the elastic wire 11 and the cavity tube 122 in fig. 3). The present application is not limited to the placement positions of the elastic wire 11 and the elastic tube 15. It should be understood that in the two or four cavity tubes 122 described above, the material, size, and rigidity of each cavity tube 122 may be the same or different. Preferably the same, to facilitate better control of the distal end of the hollow tube 122 by the retractor 13.

Preferably, when the number of hollow tubes 122 is four and the number of traction bodies 13 is two, the two parts of each traction body 13 can be wound in a closed loop at the end of the receiving portion 12 corresponding to the distal end of the elastic wire 11 and pass through different cavities 121. In one embodiment, two traction bodies 13 may be disposed at the distal end of the valve anchor 1 in a crossing manner (refer to fig. 3), and two portions of each traction body 13 wound into a closed loop may pass through the cavities 121 of two cavity tubes 122 symmetrically disposed along the axial direction of the elastic wire 11, respectively. So configured, when the valve anchor 1 begins to release (fig. 5) and the distal end of the valve anchor 1 moves away from the predetermined direction and slides toward the apex of the heart (fig. 6), the operator can secure one of the traction bodies 13 and pull on both ends of the other traction body 13, and pulling on the different traction bodies 13 can move the distal end of the valve anchor 1 in different directions, thereby enabling the traction bodies 13 to control the distal movement of the valve anchor 1 more directionally. In particular, pulling on the different traction bodies 13 can move the distal end of the valve anchor 1 in a direction away from the atrium or in a direction closer to the atrium than the predetermined direction, so that the distal end of the valve anchor 1 can be moved more accurately to the position at the time of the pre-shaping and the distal end of the valve anchor 1 can be continued to move along the wall of the predetermined chamber.

In another embodiment, two traction bodies 13 may be disposed in parallel at the distal end of the valve anchor 1, where two portions of each traction body 13 wound into a closed loop may respectively pass through the cavity 121 of the adjacent cavity tube 122, where an operator may fix one traction body 13 and pull both ends of the other traction body 13, so that the distal end of the valve anchor 1 may be moved to a predetermined position, and the distal end of the valve anchor 1 may be further moved along the wall of the predetermined chamber.

Preferably, the distal end of the receiving portion 12 is sealed, which facilitates movement of the traction body 13 within the cavity 121, reduces resistance to entry or withdrawal of the traction body 13 into the delivery system, and reduces the risk of thrombus at the distal end of the valve anchor 1. In this embodiment, referring to fig. 2, all of the cavity tubes 122 are provided with a distal seal in contact with the predetermined chamber, for example, a silicone gasket may be placed at the distal end of the cavity 121 to seal the distal end of the valve anchor 1.

More preferably, the distal end of the housing portion 12 is closed and spherical, conical or oval in shape, which on the one hand reduces the risk of thrombosis associated with implantation of the valve anchor 1; on the other hand, the distal end of the valve anchor 1 can be allowed to smoothly transition to prevent the distal end of the valve anchor 1 from scratching the myocardial wall or apex.

Referring to fig. 4, in some embodiments, the accommodating portion 12 includes a plurality of accommodating structures 123 spaced along the extending direction of the elastic wire 11, each accommodating structure 123 has at least two through holes 124 disposed side by side along the radial direction of the elastic wire 11, the through holes 124 of all the accommodating structures 123 form at least two cavities 121, and after the traction body 13 sequentially passes through a corresponding row of through holes 124 in all the accommodating structures 123 along the axis of the elastic wire 11, after the end portion of the accommodating portion 12 corresponding to the distal end of the elastic wire 11 is bent, it sequentially passes through a corresponding other row of through holes 124 in all the accommodating structures 123. In this embodiment, each accommodating structure 123 includes two rings that are connected to each other and each connected to the elastic wire 11, each ring has one through hole 124, and the traction body 13 sequentially passes through a corresponding row of through holes 124 in all the rings, and sequentially passes through a corresponding other row of through holes 124 in all the rings after being bent corresponding to the distal ends of the elastic wires 11, so as to reduce the risk of thrombus that may be caused by the cavity tube 122. In other embodiments, the two rings of each containment structure 123 may also be separate and connected to the elastic strands 11, respectively. The accommodating structure 123 is not limited to a circular ring, and the accommodating structure 123 only needs to include two through holes 124 arranged side by side, and the specific structure of the accommodating structure 123 is not limited in the present application.

The number of the accommodating structures 123 is not limited in the present application, and the number of the accommodating structures 123 may be set as needed. To allow for better control of the distal end of the valve anchor 1, the spacing between the receiving structures 123 at the distal end of the valve anchor 1 may be reduced or the wall thickness of the receiving structures 123 at the distal end of the valve anchor 1 may be increased. The connection manner of the receiving structure 123 and the elastic wire 11 is not limited in the present application, and the receiving structure 123 may be connected to the elastic wire 11 by welding, sewing or bonding.

With continued reference to fig. 1, in the expanded state, the valve anchor 1 has an anchor segment 15 for encircling the native leaflet 21, the anchor segment 15 having at least 1 turn, where the number of turns is the number of turns of the anchor segment 15 when pre-shaped. Preferably 2 turns, which allows the anchoring segment 15 to have sufficient anchoring force for the prosthetic heart valve 3 and to deform to adapt to the outer contour of the prosthetic heart valve 3 upon expansion of the prosthetic heart valve 3, so that anchoring of the prosthetic heart valve 3 can be achieved by the valve anchor 1.

To enable the valve anchor 1 to encircle the native valve leaflet 21, the inner diameter of the anchoring section 15 (i.e. the largest diameter of the lumen 14 in the valve anchor 1) generally corresponds to the size of the native valve leaflet 21, as in the present embodiment the inner contour of the anchoring section 15 has a radius of 5 mm-20 mm, and an adapted valve anchor 1 may be selected for different patients. The shape of the anchoring section 15 is not limited in the present application, and preferably, the shape of the outer contour of the anchoring section 15 after expansion corresponds to the shape of the inner contour of the native valve leaflet 21, so as to achieve better anchoring, for example, the shape of the anchoring section 15 after expansion may be circular, circular arc, oval, or the like.

In one embodiment, the anchor segment 15 may be wound from a material of the elastic wire 11 and a material of the hollow tube 122. In another embodiment, the anchoring section 15 may be formed by connecting two or more elastic wires 11 of materials and two or more hollow tubes 122 of materials in sections, for example, the elastic wires 11 of different kinds of materials may be connected to each other, the hollow tubes 122 of different kinds of materials may be connected to each other, and then the elastic wires 11 and the hollow tubes 122 may be connected to each other in the radial direction to form the anchoring section 15.

To increase the friction of the anchoring section 15 during anchoring, i.e. to further increase the anchoring effect of the valve anchor 1 in the heart, a high friction coefficient coating may be applied to the surface of the anchoring section 15. The Gao Maca coefficient cover may be a combination of one or more of polyethylene and PET materials.

Referring to fig. 1 and 5, in the expanded state, the valve anchor 1 preferably further has a grasping section 16 axially connected to the anchoring section 15, the grasping section 16 having a radius of curvature greater than that of the anchoring section 15 so that the valve anchor 1 moves along the wall of the predetermined chamber and expands to shape when implanted. Due to the larger radius of the grasping section 16, the grasping section 16 is allowed to always abut against the lumen wall of the predetermined chamber when the valve anchor 1 is released within the delivery sheath 4, so that the valve anchor 1 can grasp all of the native tissue, such as native valve leaflets 21 and chordae tendineae 22, and will contain the native tissue, such as native valve leaflets 21 and chordae tendineae 22, within the lumen 14 (i.e., around all of the native valve leaflets 21 and chordae tendineae 22) as the valve anchor 1 is moved, so as to ensure that the prosthetic heart valve 3 is able to abut against the native valve leaflets 21 after implantation. When the valve anchor 1 passes through the middle of the chordae tendineae 22, that is, the valve anchor 1 fails to accommodate the native valve leaflet 21 and the chordae tendineae 22 in the inner cavity 14, since a portion of the chordae tendineae 22 tissue is located outside the valve anchor 1 at this time, the prosthetic heart valve 3 cannot be closely attached to a portion of the native valve leaflet 21 after implantation, which may result in the generation of paravalvular leakage and may result in failure of the operation of the prosthetic heart valve 3.

Of course, if the traction body 13 has sufficient strength, for example, by using a stiffer material for the traction body 13 or by increasing the wall thickness of the material from which the traction body 13 is made, the radius of curvature of the various parts of the anchoring segment 15 can be increased so that the anchoring segment 15 can move itself along the wall of the predetermined chamber after release. After the valve anchor 1 is fully implanted, the traction body 13 is pulled away, and the anchoring section 15 can automatically recover to a coil structure with smaller curvature radius when in a preset shape and cling to the native valve leaflet 21, so that the valve anchor 1 can adapt to the external contour of the artificial heart valve 3 and provide anchoring force for the artificial heart valve 3. So arranged, the valve anchor 1 can reduce the initial radius of curvature of the grasping section 16 or make the radius of curvature of the grasping section 16 the same as the radius of curvature of the anchoring section 15, at which time the grasping section 16 will not float inside the predetermined chamber after implantation of the valve anchor 1, thereby facilitating long-term implantation of the valve anchor 1 in the human body.

In order to enable the gripping section 16 to be moved along the lumen wall of the predetermined chamber at all times during movement, the radius of curvature of the gripping section 16 generally corresponds to the size of the predetermined chamber, i.e. the radius of the expanded outer contour of the gripping section 16 corresponds to the radius of the inner contour of the predetermined chamber, and the adapted valve anchor 1 can be selected according to the individual patient, so that the valve anchor 1 can be moved against the lumen wall of the predetermined chamber without being inserted into the myocardial wall relatively easily.

The shape of the grabbing section 16 is not limited in the present application, and the grabbing section 16 may have a circular arc structure or a coil structure. When the grabbing section 16 is in an arc structure, the grabbing section 16 can be formed by single arc or multiple arc connection, and the length of the arc can be set according to the requirement. Wherein, the curvature radius of each arc section in the multiple arc sections forming the grabbing section 16 is 10 mm-30 mm, so that the valve anchoring member 1 is better assisted to grab all the structures of the native valve leaflets 21, chordae tendineae 22 and the like. When the grasping section 16 is a coil structure, the number of turns of the coil structure is not more than 2 turns, so that the grasping section 16 can be easily deformed to change the moving direction by pulling of the pulling body 13.

To reduce friction during movement of the gripping section 16, i.e. to further reduce the resistance during movement of the gripping section 16, the surface of the gripping section 16 may be coated with a coating having a low coefficient of friction. The low friction coating may be one or a combination of polytetrafluoroethylene or velvet cloth.

In one example, the anchoring segment 15 and the grasping segment 16 can be made from different elastic wires 11 and hollow tubes 122, respectively, and the anchoring segment 15 and the grasping segment 16 can be connected to each other to form the valve anchor 1, i.e., the anchoring segment 15 and the grasping segment 16 are formed separately and then connected to each other. In other examples, an elastic wire 11 and a hollow tube 122 connected to each other may be used to sequentially wind the anchoring section 15 and the grasping section 16 to form the integrated valve anchor 1.

In a non-limiting embodiment, taking mitral valve replacement as an example, the implantation procedure of the valve anchor 1 and prosthetic heart valve 3 is:

referring to fig. 5-8, the valve anchor 1 is contracted in the delivery sheath 4, the delivery sheath 4 may be advanced into the left ventricle via the aorta, atrium, or other route, and then the valve anchor 1 may be advanced to the sheath orifice of the delivery sheath 4 and release of the valve anchor 1 may begin in the left ventricle. First, the gripping section 16 of the valve anchor 1 is pushed out of the delivery sheath 4, and the gripping section 16 can be advanced along the lumen wall as the valve anchor 1 moves through the ventricle due to the large radius of curvature of the gripping section 16 after being pre-shaped. As shown in fig. 6, when the valve anchor 1 is disturbed by the movement of the ventricular wall or the distal end of the valve anchor 1 enters the slit in the longitudinal direction of the heart muscle, the distal end of the valve anchor 1 may slide in the direction of the apex of the heart, at which time the advancement of the valve anchor 1 is stopped, and the distal end of the valve anchor 1 is separated from the wall of the heart muscle by pulling both ends of the traction body 13 and returned to the position at the time of the predetermined shaping, and the distal end of the valve anchor 1 is again made parallel to the native annulus, so that the distal end of the valve anchor 1 can continue to move along the wall of the predetermined chamber. And then the valve anchor 1 is continuously pushed, if the distal end of the valve anchor 1 moves towards the apex direction again during the release process of the valve anchor 1, the traction body 13 can be pulled again to adjust the moving direction of the distal end of the valve anchor 1, and the operation is repeated until the valve anchor 1 can encircle all the native tissues such as the native valve leaflets 21, the chordae tendineae 22 and the like. Upon confirming that the valve anchor 1 has completely disengaged from the delivery sheath 4 and is able to encircle the native leaflets 21, the delivery system is allowed to maintain the position of the valve anchor 1 and implantation of the prosthetic heart valve 3 begins.

The prosthetic heart valve is used to replace and substitute a native mitral valve. The prosthetic heart valve 3 may enter the atrium via the inferior vena cava or other route and cross the native leaflets 21 into the lumen 14 of the valve anchor 1; the artificial heart valve 3 can be expanded by balloon disposable balloon expansion or adopting a self-expanding sheath and the like, the anchoring section 15 in the valve anchoring member 1 can generate elastic deformation or plastic deformation during the expansion, the anchoring section 15 can adapt to the shape of the annular section 32 in the artificial heart valve 3 during the deformation, and the anchoring section 15 is fully fixedly connected and sealed with the annular section 32, so that the valve anchoring member 1 and the artificial heart valve 3 are fixedly connected into a whole. The anchoring section 15 is capable of applying an anchoring force to the expanded prosthetic heart valve 3 to effect anchoring of the prosthetic heart valve 3 at the native leaflet 21 site.

As shown in fig. 8, taking the kidney-shaped prosthetic heart valve 3 as an example, the prosthetic heart valve 3 includes an outflow section 31, an annular section 32 and a flange section 33 which are axially connected in order, and after the prosthetic heart valve 3 is expanded, the inner diameters of the outflow section 31 and the flange section 33 are both larger than the inner diameter of the annular section 32. After implantation of the valve anchor 1 and prosthetic heart valve 3, the implantation positions of the valve anchor 1 and prosthetic heart valve 3 need to be adjusted so that the valve anchor 1 is positioned at the annulus segment 32 of the prosthetic heart valve 3 and so that the valve anchor 1 encircles and abuts the native valve leaflet 21, at which point the expanded prosthetic heart valve 3 can provide an anchoring force to the valve anchor 1 within the predetermined subject. At the same time, the outflow section 31 and the flange section 33 with larger radii can limit the annular section 32 of the prosthetic heart valve 3 in the axial direction, even if the annular section 32 can only be located at the position of the valve anchor 1, so that it is ensured that the prosthetic heart valve 3 cannot move in the axial direction after implantation. After the prosthetic heart valve 3 has been fully expanded, the operator can withdraw the traction body 13 and withdraw the delivery system after confirming that the prosthetic heart valve 3 and the valve anchor 1 have been firmly implanted in the predetermined position, thereby completing the implantation procedure of the prosthetic heart valve 3 and the valve anchor 1.

It should also be appreciated that the valve system provided by embodiments of the present invention may include the valve anchor 1 provided in any of the embodiments.

In summary, in the valve anchoring member 1 and the valve system provided by the invention, the valve anchoring member 1 with the elastic wire 11 can be expanded gradually and surrounds the native valve leaflets after expansion, and the valve anchoring member 1 can also adjust the moving direction of the distal end of the valve anchoring member 1 through the traction body 13 in the expansion process, so that the valve anchoring member 1 can be ensured to always move along the cavity wall of a preset cavity, and the valve anchoring member 1 can be enabled to be always parallel to the native valve annulus without being interfered by the periodical motion of the heart in the moving process, so that the valve anchoring member 1 can be ensured to grasp all the native tissues such as the native valve leaflets 21, the chordae 22 and the like after complete expansion, and the influence of the heart anatomy structure on the heart cusp direction or the heart muscle puncture is avoided, and the reliability and the safety of the operation of the artificial heart valve 3 can be further improved. In addition, the valve system does not need a rope sleeve structure to capture the guide wire, so that the implantation process of the valve anchoring piece 1 can be simplified, the implantation difficulty of the valve anchoring piece 1 can be reduced, the success rate of implantation of the artificial heart valve 3 can be improved, and further the injury to a patient can be reduced, and the postoperative rehabilitation of the patient is facilitated.

The valve anchor 1 provided by the invention comprises an anchor section 15, wherein the anchor section 15 can realize the connection of the artificial heart valve 3 and the anchor section 15 through interference fit between the inner cavity 14 and the artificial heart valve 3, and apply anchoring force to the artificial heart valve 3. After implantation of the valve anchor 1, the pulling body 13 is withdrawn, and the valve anchor 1 can adapt to the outer contour of the prosthetic heart valve 3, so that the prosthetic heart valve 3 can be fixed in a predetermined subject by the valve anchor 1.

The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present invention.

Claims

1. A valve anchor, wherein the valve anchor has a contracted state and an expanded state, and is switchable between the contracted state and the expanded state;

2. The valve anchor of claim 1, wherein the valve anchor is spiral in shape and has an annular lumen for receiving a prosthetic heart valve; the valve anchor is capable of adapting to the outer contour of the expanded prosthetic heart valve upon deformation under force to apply an anchoring force to the prosthetic heart valve.

3. The valve anchor of claim 2, wherein in the expanded state the valve anchor has an anchor segment surrounding a native valve She Yong, the anchor segment having at least one turn of a coil, the valve anchor further having a grasping segment axially connected to the anchor segment; the radius of curvature of the grabbing section is larger than that of the anchoring section, so that the valve anchoring piece moves along the cavity wall of the preset cavity when being implanted and expands and forms.

4. The valve anchor of any one of claims 1-3, wherein a plurality of independently disposed cavities are provided in the receiving portion for the traction body to pass through, one of the traction bodies passing through one of the cavities and then penetrating the other of the cavities after bending at an end of the receiving portion corresponding to the distal end of the elastic wire.

5. The valve anchor of claim 4, wherein the number of said traction bodies is one, said receiving portion comprises two cavity tubes arranged side by side, both of said cavity tubes being arranged parallel to said elastic wire, both of said cavity tubes being interconnected and/or connected to said elastic wire, each of said cavity tubes having one of said cavities such that two portions of one of said traction bodies are respectively threaded into both of said cavity tubes.

6. The valve anchoring member according to claim 4, wherein the number of the traction bodies is two, the accommodating portion comprises four cavity tubes sequentially distributed along the circumferential direction of the elastic wire, the four cavity tubes are arranged in parallel with the elastic wire, the four cavity tubes are connected with each other and/or the elastic wire, each cavity tube is provided with one cavity, and two parts of each traction body respectively penetrate into the corresponding two cavity tubes.

7. The valve anchor of claim 4, wherein a distal end of the receptacle is sealingly disposed.

8. The valve anchor of claim 7, wherein the distal end of the receptacle is closed and spherical, conical or elliptical in shape.

9. The valve anchor of claim 4, wherein the receiving portion includes a plurality of receiving structures spaced apart along the direction of extension of the elastic wire, each of the receiving structures having at least two through holes disposed side-by-side along the radial direction of the elastic wire, the through holes of all of the receiving structures comprising at least two of the cavities, the traction body passing sequentially through one of the rows of through holes of all of the receiving structures along the axis of the elastic wire, and then sequentially through the other of the rows of through holes of all of the receiving structures after bending an end of the receiving portion corresponding to the distal end of the elastic wire.

10. A valve system comprising a prosthetic heart valve for receipt therein, and the valve anchor of any one of claims 1-9.