CN115607338A - Transcatheter heart valve replacement system - Google Patents

Abstract

The invention relates to a transcatheter heart valve replacement system, which structurally comprises a heart valve prosthesis and a valve anchoring device, wherein the valve anchoring device comprises at least one annular component, the heart valve prosthesis comprises a valve support, and the valve support at least comprises a main body part; the annular member is provided with a first connector having a tendency to extend towards the main body portion, the first connector either piercing or not piercing the native leaflets and cooperating with the main body portion; and/or the main body portion is provided with a second connector having a tendency to extend towards the annular member, the second connector either piercing or not piercing the native leaflets and co-operating with the annular member. The invention can provide more layers of interaction force between the artificial heart valve and the valve anchoring device, so that the artificial heart valve and the valve anchoring device are more tightly combined and generate stable anchoring force, and the artificial heart valve is prevented from displacement or deformation in the cardiac phase.

Description

Transcatheter heart valve replacement system

Technical Field

The invention relates to the field of medical instruments for cardiac intervention, in particular to a transcatheter heart valve replacement system.

Background

In recent years, the field of transcatheter heart valve interventional therapy has rapidly developed, wherein the design difficulties of transcatheter heart valve instruments include: "replace the patient's heart valve, restore normal heart blood flow" and "anchor the prosthetic valve at the patient's heart valve and avoid paravalvular leakage".

Compared with the traditional valve products (the artificial valve needs to complete ' valve anchoring ' and ' replace the diseased valve of the patient), the heart valve replacement system consisting of the artificial heart valve and the anchoring instrument has the following advantages:

(1) The structure of the prosthetic valve is simpler and only needs to consider how to restore normal cardiac blood flow. The valve does not need to be anchored, the heart anatomy of the human body does not need to be considered (the valve does not need to be D-shaped);

(2) The artificial valve is anchored by a fishing ring, and has less harm to a human body compared with the barb anchoring of the traditional valve (the barb needs to prick into cardiac muscle);

(3) Prosthetic valves are suitable for more patients, and conventional valves rely on prosthetic valve circumferences that are larger than the patient's own annulus circumference (oversize use) to achieve valve fixation and prevent paravalvular leakage. The novel device realizes valve fixation and prevents paravalvular leakage by means of the cooperation of the artificial valve and the catching ring, can be suitable for more patients, and reduces paravalvular leakage.

Such a heart valve replacement system consisting of two-part instruments (prosthetic heart valve and anchoring instrument) needs to solve a key technical problem: how to stably connect the artificial heart valve and the anchoring device avoids abnormal phenomena of axial movement, radial rotation and the like of the valve after the artificial heart valve is implanted.

Disclosure of Invention

The invention discloses a transcatheter heart valve replacement system, which aims to solve the technical problems in the prior art.

The invention adopts the following technical scheme:

a transcatheter heart valve replacement system is provided, comprising a prosthetic heart valve and a valve anchoring device;

the valve anchoring device comprises at least one annular member; the valve anchoring device is capable of being positioned outside the native valve chordae tendineae and conforming to changes in the native valve annulus morphology;

the artificial heart valve comprises a valve support, wherein the valve support comprises a main body part, and a flow channel for blood circulation is defined in the main body part; the prosthetic heart valve can be positioned inside the native valve and replace the physiological function of the native valve;

the annular member is provided with a first connector having a tendency to extend towards the main body portion, the first connector either piercing or not piercing the native leaflets and cooperating with the main body portion;

and/or the body portion is provided with a second connector having a tendency to extend towards the annular member, the second connector either piercing the native leaflets or not and co-operating with the annular member.

Preferably, the valve anchoring device comprises a plurality of annular members, and adjacent annular members are connected end to end and have a spiral structure.

Preferably, the valve anchoring device comprises a plurality of annular members, each annular member is in a closed ring shape, the annular members are axially arranged in parallel, and adjacent annular members are elastically connected.

Preferably, the axial length of at least part of the annular member is adapted to the axial length of the main body portion, and/or the inner diameter of at least part of the annular member is adapted to the outer diameter of the main body portion.

As the preferred technical scheme, the main body part is in a net pipe shape and is provided with a plurality of polygonal grid structures which are connected with each other.

As a preferred technical solution, the valve stent further comprises a skirt portion; the skirt edge part is in a flange disc-shaped structure, and the small-diameter end of the skirt edge part is connected with the main body part.

Preferably, the first connector comprises a plurality of first anchoring arms disposed inwardly of at least a portion of the annular member and extending radially inwardly.

As a preferred technical scheme, the first anchoring arm is straight or arc-shaped;

the first anchoring arm is bent towards the direction departing from the blood flow; alternatively, the first anchoring arm is bent toward a direction compliant with blood flow.

Preferably, the first connecting element comprises a plurality of anchoring grooves, which are arranged on the inner side of at least part of the ring-shaped element and which have a contour adapted to the second connecting element.

As a preferred technical scheme, the anchoring groove comprises a variable diameter section arranged on the annular member, and the variable diameter section is in a waisted shape.

Preferably, the first connecting member includes a plurality of magnetic members, and the magnetic members are disposed on the annular member in a U-shape, a ring shape, or a spiral shape, and at least a portion of the magnetic members face radially inward of the annular member.

As a preferable technical scheme, a plurality of first connecting pieces are circumferentially and symmetrically distributed on the inner side of at least part of the annular component; alternatively, the first and second electrodes may be,

the first connecting pieces are circumferentially distributed on the inner side of at least part of the annular component in a staggered mode.

As a preferred technical scheme, the second connecting piece comprises a plurality of second anchoring arms, the second anchoring arms are arranged on the outer side of the main body part, and the second anchoring arms are straight or arc-shaped; the second anchoring arm can be configured to extend radially outward when the valve stent is expanded.

Preferably, the second anchoring arm is bent in a direction away from the blood flow; alternatively, the second anchoring arm is bent toward a direction compliant with blood flow.

Preferably, the length of the second anchoring arm is greater than the cross-sectional diameter of the annular member.

As a preferred technical scheme, the second connecting piece comprises a plurality of reducing sections arranged on the grid structure, and the reducing sections are waisted.

Preferably, the second connector comprises a plurality of magnetic members, and the magnetic members are arranged on the grid structure in a U shape, a ring shape or a spiral shape, and at least part of the magnetic members face the radial outer side of the main body part.

As a preferred technical scheme, a plurality of second connecting pieces are circumferentially and symmetrically distributed on the outer side of the main body part; alternatively, the first and second electrodes may be,

the plurality of second connecting pieces are circumferentially distributed on the outer side of the main body part in a staggered manner.

According to a preferable technical scheme, the first connecting piece comprises metal or other hard high polymer materials, and the first connecting piece is fixedly connected with the annular member or integrally formed;

and/or the second connecting piece comprises metal or other hard high polymer materials, and the second connecting piece is fixedly connected with the main body part or integrally formed.

The technical scheme adopted by the invention can achieve the following beneficial effects:

(1) The invention provides a transcatheter heart valve replacement system, which consists of a prosthetic heart valve and a valve anchoring device, wherein the valve anchoring device can surround the outer side of valve chordae tendineae and provides positioning points for the implantation of a subsequent prosthetic heart valve while capturing native valve leaflets; the artificial heart valve can be implanted in a mitral valve and a tricuspid valve and replace the physiological functions of a native valve. The valve anchoring device and the prosthetic heart valve are capable of cooperating with each other to prevent undesired displacement of the prosthetic heart valve due to tissue relaxation/contraction during the cardiac cycle. In order to further increase the structural fit between the prosthetic heart valve and the valve anchoring device, at least one of the two is provided with a connecting member capable of piercing or not piercing the native valve leaflets and connecting the other one, so that the prosthetic heart valve and the valve anchoring device are more tightly combined and generate a stable anchoring force to prevent the prosthetic heart valve from being displaced, deformed or radially rotated in the cardiac phase.

(2) In some preferred embodiments, a first connector may be provided inside the valve anchoring device, which may be an anchoring arm, an anchoring slot, or a magnetic member; when the first connector is an anchoring arm, the anchoring arm is capable of piercing radially inward the native leaflet or yet further connecting with a connector on the prosthetic heart valve; when the first connecting piece is the anchoring groove, the connecting piece on the artificial heart valve can pierce the native valve leaflet and is connected with the anchoring groove; when the first connector is a magnetic member, at least a portion of the section of the prosthetic heart valve is also configured as a magnetic member or is ferromagnetic, and the magnetic member is preferably textured or structured with surface irregularities to provide a magnetic connection while providing a high frictional force.

(3) In some preferred embodiments, a second connector may be provided on the outside of the prosthetic heart valve, which may be an anchoring arm, an anchoring slot, or a magnetic member; when the second connecting piece is the anchoring arm, the anchoring arm can radially penetrate out of the native valve leaflet and is abutted against the valve anchoring device, the anchoring arm is long in length, and preferably, the anchoring arm has a contour matched with the valve anchoring device on one side abutted against the valve anchoring device, so that the anchoring arm and the valve anchoring device can be stably connected, the artificial heart valve cannot be easily separated from the valve anchoring device, and even if the heart generates or suffers from large-amplitude tremor or the native valve generates organic lesions again, the replacement system can still normally play a role; when the second connecting piece is an anchoring groove, the connecting piece on the valve anchoring device can pierce through the native valve leaflet and is connected with the anchoring groove; when the second connector is a magnetic member, it is preferable to use the same magnetic member as in the valve anchoring device to provide both a magnetic connection and a large frictional force.

(4) The artificial heart valve and the valve anchoring device can be simultaneously provided with connecting pieces, and the connecting pieces of the artificial heart valve and the valve anchoring device are mutually matched; or a connecting piece can be arranged in one of the two parts and is directly matched with the other part; both arrangements allow a stable connection between the prosthetic heart valve and the valve anchoring device.

(5) In a preferred embodiment of the invention, the inflow end of the artificial heart valve is provided with the skirt part, and the sealing membrane is sewn on the outer side of the skirt part, so that the paravalvular leakage can be effectively prevented, and the operation risk is reduced.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly introduced below to form a part of the present invention, and the exemplary embodiments and the description thereof illustrate the present invention and do not constitute a limitation of the present invention. In the drawings:

FIG. 1 is a schematic view of a preferred embodiment of a valve anchoring device disclosed in example 1 of the present invention;

FIG. 2 is a schematic structural view of a valve stent according to a preferred embodiment disclosed in example 1 of the present invention;

FIG. 3 is a view showing the engagement of a valve stent with a valve anchoring device according to a preferred embodiment of the present invention disclosed in example 1;

FIG. 4 is a schematic view of a preferred embodiment of the valve anchoring device disclosed in example 2 of the present invention;

FIG. 5 is a schematic view of another preferred embodiment of the valve anchoring device disclosed in example 2 of the present invention;

FIG. 6 is a schematic structural view of a valve stent according to another preferred embodiment disclosed in example 2 of the present invention;

FIG. 7 is an enlarged view of a portion of FIG. 6 at A;

FIG. 8 is a view of the engagement of a valve stent with a valve anchoring device in accordance with a preferred embodiment of the present invention as disclosed in example 2;

FIG. 9 is a view of the engagement of the second anchoring arms with the annular member in accordance with a preferred embodiment of the present invention as disclosed in example 2;

FIG. 10 is a view of a preferred embodiment of the valve anchoring device in use in the heart, as disclosed in example 2 of the present invention;

FIG. 11 is a diagram of a preferred embodiment heart valve replacement system as disclosed in example 2 of the present invention in use inside the heart;

FIG. 12 is a schematic view of a preferred embodiment of the valve anchoring device disclosed in example 4 of the present invention;

FIG. 13 is a schematic view of a preferred embodiment of the valve anchoring device disclosed in example 5 of the present invention;

FIG. 14 is a schematic view of a preferred embodiment of the valve anchoring device of the present invention as it is being delivered, according to example 5 of the present invention;

FIG. 15 is a schematic view of a preferred embodiment of the valve anchoring device of the present invention as released in example 5;

FIG. 16 is a view of the engagement of a valve stent with a valve anchoring device in accordance with a preferred embodiment of the present invention as disclosed in example 5;

FIG. 17 is a schematic view of a preferred embodiment of the valve anchoring device disclosed in example 6 of the present invention;

FIG. 18 is a view showing the engagement of a valve stent and a valve anchoring device in a preferred embodiment of the present invention disclosed in example 6;

description of the reference numerals:

valve stent 100, second anchoring arm 110, body portion 120, wave bar 121, node 122, skirt portion 130;

valve anchoring device 200, 200', annular member 210, 210', first anchoring arm 220, 220', resilient connecting element 230, snap-in structure 240, anchoring groove 250, magnetic member 260;

left atrium 300, left ventricle 400, native leaflets 500, chordae tendineae 600.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to the specific embodiments of the present invention and the accompanying drawings. In the description of the present invention, it is noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or magnetically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in a specific case to those of ordinary skill in the art. In addition, in the description of the present application, the terms "first", "second", and the like are used only for distinguishing the description, and are not intended to indicate or imply relative importance.

It is to be understood that the disclosed embodiments are merely exemplary of the invention, and are not intended to be exhaustive or exhaustive. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

To address the problems in the prior art, embodiments of the present application provide a transcatheter heart valve replacement system, comprising a prosthetic heart valve and a valve anchoring device; the valve anchoring device comprises at least one annular member; the valve anchoring device is capable of being positioned outside the native valve chordae tendineae and conforming to changes in the native valve annulus morphology; the artificial heart valve comprises a valve support, wherein the valve support comprises a main body part, and a flow passage for blood to flow is defined in the main body part; the prosthetic heart valve can be positioned inside the native valve and replace the physiological function of the native valve; the annular member is provided with a first connector which has a tendency to extend towards the main body portion, and the first connector pierces or does not pierce the native valve leaflets and is mutually matched with the main body portion; and/or the main body portion is provided with a second connector having a tendency to extend towards the annular member, the second connector either piercing or not piercing the native leaflets and co-operating with the annular member.

Example 1

To address the problems of the prior art, the present embodiments provide a transcatheter heart valve replacement system that may be applied to any valve in the heart; for convenience of explanation, this embodiment will be described with reference to transcatheter mitral valve replacement as an example.

Referring to fig. 1-3, a heart valve replacement system includes a prosthetic heart valve and a valve anchor 200; the artificial heart valve comprises a valve stent 100 and artificial valve leaflets; the valve-anchoring device 200 includes at least one annular member 210 that is implantable at the chordae tendineae 600 plexus of the mitral valve and provides axial and radial forces to cooperate and interact with a prosthetic heart valve implanted within the mitral valve, which cooperate to reduce the size of the native mitral valve and reduce mitral regurgitation, while the valve-anchoring device 200 can more securely anchor the position of the prosthetic heart valve, effectively avoiding the prosthetic heart valve from shifting during myocardial motion.

Preferably, the artificial leaflet is made of a commercially available porcine aortic valve, bovine pericardial valve or porcine pericardial valve, or is made of a biocompatible polymer material for replacing the physiological function of the native leaflet 500; preferably, the artificial leaflets are sewn to the inside of the valve stent 100.

Preferably, a sealing membrane is also sewn to the inflow end of the valve holder 100 to prevent paravalvular leakage.

In a preferred embodiment, the valve stent 100 is made of biocompatible metal, has two configurations of collapse and expansion, can be delivered in the human body in the collapsed configuration, and can be radially expanded by balloon expansion, mechanical dilator or its own shape memory properties, and has a substantially mesh-like shape after implantation in the heart and expansion, with a central portion extending through the defined space for blood flow; the valve stent 100 is capable of anchoring at the native annulus and receiving the prosthetic valve leaflets.

Optionally, when the valve stent 100 is configured as a self-expanding stent, the valve stent 100 is made of a shape memory alloy, such as nitinol or copper-aluminum-nickel alloy; optionally, when the valve stent 100 is configured as a balloon-expandable or mechanically-expandable stent, the valve stent 100 is made of a material such as stainless steel or a cobalt-based alloy.

In a preferred embodiment, the valve stent 100 is a self-expanding stent formed by processing a shape memory alloy material, including but not limited to weaving, laser cutting, welding, riveting, threading, etc., to form a multi-row interconnected polygonal lattice structure, as shown in fig. 2; the adjacent grid structures are connected through wave bars 121 or nodes 122 with certain elasticity, wherein the grid structures can be arranged into rhombic grids or hexagonal grids; preferably, the upper and lower opposite corners of the lattice structure are V-shaped.

In a preferred embodiment, the valve stent 100 comprises a body portion 120, the body portion 120 is a cylindrical structure or a similar cylindrical structure, and can be positioned at the connecting transition region of the native leaflets 500 of the mitral valve and the chordae tendineae 600, and is mutually matched with the valve anchoring device 200; more preferably, the valve stent 100 further comprises a skirt portion 130; wherein the skirt 130 is disposed at the inflow end of the entire valve holder 100 and is positionable at the annulus of the mitral valve, the skirt 130 is preferably configured as a flange-disk-shaped structure, and a sealing membrane is disposed inside or outside the skirt 130 to further prevent paravalvular leakage. The main body portion 120 and the skirt portion 130 are radially expandable and compressible to ensure that they are compressed during delivery in a blood vessel and then expand to open by self-expansion after reaching the mitral valve.

In a preferred embodiment, the valve anchoring device 200 is configured in a generally helical configuration, as shown in fig. 1, in which case the valve anchoring device 200 can be considered as being formed by a plurality of open-loop annular members 210 joined end-to-end, with each helix being one annular member 210; on the one hand, the helical structure provides both axial and radial deformability to accommodate changes in the morphology of the myocardial tissue throughout the cardiac cycle, while also facilitating surgical placement, and on the other hand, provides radially inward contractive forces to support, mate with, and anchor the main body portion 120 of the valve stent 100.

In a preferred embodiment, the valve anchoring device 200 is helically coiled from a pre-formed shape memory metal, preferably a nickel-titanium alloy, that is elastically deformable at least radially and axially to conform to changes in the shape of the myocardial tissue; the valve anchoring device 200 can be delivered in a straight line in the human body and can be wound around the chordae tendineae 600 after release in the left ventricle 400.

Preferably, the valve anchoring device 200 comprises at least two annular members 210, the distance between adjacent annular members 210 being 1.0-5.0mm; preferably, the axial length of the valve anchoring device 200 is adapted to the length of the body portion 120 of the valve stent 100; preferably, the inner diameter of the valve anchoring device 200 is adapted to the outer diameter of the body portion 120 of the valve stent 100.

Further, the shape and size of the atrium/valve/ventricle may vary from patient to patient, and those skilled in the art will appreciate that the specific size of the valve anchoring device 200 and the number of annular members 210 provided may be adapted according to the patient's condition.

Preferably, the valve anchoring device 200 is provided with a first connector on at least one annular member 210, the first connector being configured as a plurality of first anchoring arms 220, preferably the plurality of first anchoring arms 220 being circumferentially arranged inside the annular member 210 and extending in the direction of the body portion 120.

Optionally, the first anchoring arm 220 may be made of memory alloy, polymer, fiber or other high polymer material, and is fixedly connected by riveting, welding, crimping, adhering or welding; in a more preferred embodiment, the first anchoring arms 220 are made of the same material as the annular member 210, and can be integrally formed, and the first anchoring arms 220 are preformed to extend radially inward, so as to ensure that the first anchoring arms 220 are attached to the surface of the annular member 210 when the valve-anchoring device 200 is delivered in a straight line shape, thereby avoiding damage to the delivery system or human body.

Optionally, the first anchoring arms 220 extend radially inward toward a direction away from blood flow; preferably, the first anchoring arms 220 extend radially inward and toward the blood flow-compliant direction, corresponding to the mitral valve, i.e. extend radially obliquely downward, forming a barb-like structure, and on the one hand, the valve anchoring device 200 can move downward by a certain distance under the influence of its own weight, and during the movement, the first anchoring arms 220 can penetrate the native leaflets 500, so that the combination of the valve anchoring device 200 and the native tissue is more secure; on the other hand, during the downward movement of the valve anchoring device 200, the first oblique anchoring arm 220 also limits the movement thereof, so as to achieve a good limiting effect.

Preferably, the first anchoring arm 220 is angled at an acute angle to the vertical, more preferably 30-75 °.

In a preferred embodiment, the first anchoring arm 220 is a flat structure, extending radially inward in a straight line shape; in another preferred embodiment, the first anchoring arm 220 extends inwardly in a generally arcuate shape, as shown in FIG. 1; in other preferred embodiments, the first anchoring arm 220 can also be tilted in a clockwise or counterclockwise direction to further increase the contact area between the first anchoring arm 220 and the native tissue after penetrating the native leaflet 500, thereby further ensuring the tightness and stability of the combination of the two.

In a preferred embodiment, the length of the first anchoring arm 220 is defined as: allowing it to penetrate the native leaflets 500, but not piercing the native leaflets 500; at this time, the valve anchoring device 200 and the valve stent 100 are not in direct contact with each other, but the anchoring action is enhanced by further increased friction therebetween.

In another preferred embodiment, the length of the first anchoring arm 220 is defined as: allowing it to pierce the native leaflets 500, but not beyond the inner wall of the prosthetic heart valve; at this time, there may be direct contact between the valve-anchoring device 200 and the valve stent 100, and there may be not only friction but also other forces therebetween. The length of the first anchoring arm 220 is set not to exceed the inner wall of the artificial heart valve, so as to prevent the first anchoring arm from puncturing the artificial valve leaflet and causing the artificial heart valve to fail.

Preferably, when the first anchoring arm 220 can pierce the native leaflet 500, its structure is configured to be substantially arc-shaped; more preferably, a second connector is provided where the valve stent 100 may abut the first anchoring arms 220, in which case the second connector may be provided as: a groove or a waisted shape matched with the profile of the first anchoring arm 220 is arranged on the wave rod 121 at the position corresponding to the position of the first anchoring arm 220; specifically, some of the wave bars 121 may be tapered to form a waisted structure.

It will be understood by those skilled in the art that when the first anchoring arms 220 can pierce the native leaflets 500, they do not necessarily have to abut against the wave bars 121 on the valve holder 100, but may also penetrate the sealing membrane of the valve holder 100, in which case it can be considered that there is no direct contact between the valve-anchoring device 200 and the valve holder 100, but there is direct contact between the valve-anchoring device 200 and the prosthetic heart valve. Therefore, in the present embodiment, the second connecting element is not required to be disposed, and the second connecting element may not be disposed.

In a preferred embodiment, the first anchoring arms 220 may be disposed on a plurality of annular members 210 and may be circumferentially symmetrically distributed or circumferentially staggered.

It will be understood by those skilled in the art that, since different patients have different ages, sexes, heights, weights, lesion positions, lesion conditions, etc., in order to ensure that the heart valve replacement system can be well fitted with the native valve to function, the sizes of the prosthetic heart valve and the valve anchoring device 200 and the relative position angles thereof can be adjusted or selected adaptively, and will not be described herein again.

In the present embodiment, the method of using the above-mentioned prosthetic heart valve is as follows:

the valve anchor 200, when delivered, is disposed in a straight line in the delivery device, through which the valve anchor 200 is transvascularly or transapically accessed to the left ventricle 400, and delivered between the mitral chordae tendineae 600 and the wall of the left ventricle 400. The valve anchoring device 200 is passed through the gap between the chordae 600 and the wall of the left ventricle 400, is delivered along the wall of the left ventricle 400, and finally wraps the chordae 600, as can be seen in fig. 10. On one hand, the capture of the mitral valve leaflets is realized, and on the other hand, the anchoring position is provided for the implantation of a subsequent artificial heart valve.

After release of the valve anchor 200, the radially inner first connectors also return to the pre-shaped configuration, i.e., extend radially inward, and penetrate into the native leaflets 500.

The prosthetic heart valve is compressed by the transporter and then enters the femoral vein, and is released after passing through the interatrial septum and reaching the mitral valve, the main body part 120 of the valve stent 100 is correspondingly arranged at the radial inner side of the valve anchoring device 200, and referring to fig. 11, the skirt part 130 is correspondingly arranged at the left atrium 300 side of the mitral valve, so as to prevent perivalvular leakage and reduce the surgical risk.

In one aspect, when the first connector length of the valve anchoring device 200 can only penetrate the native leaflets 500 without piercing, there is no direct contact between the valve anchoring device 200 and the valve support 100, enhancing the anchoring effect by further increased friction between the two.

On the other hand, when the first connector of the valve anchoring device 200 is long enough to pierce through the native valve leaflet 500, there is a possibility of direct contact between the valve anchoring device 200 and the valve support 100, and there is not only friction between the two, but also other acting forces, and at this time, the valve support is preferably provided with a second connector which can be shape-matched with the first connector and stably abut against each other, so as to provide a better and stable anchoring force, prevent the valve support 100 from being displaced in the cardiac phase, and make the artificial heart valve and the native tissue structure fit more safely and stably.

Example 2

Still taking the example of mitral valve implantation, in this embodiment, a transcatheter heart valve replacement system is provided that also includes a prosthetic heart valve and a valve anchoring device 200.

As shown in fig. 4 and 5, the valve anchoring device 200 is preferably configured in a substantially spiral structure and has a plurality of end-to-end annular members 210, and the structure of the annular members 210 is the same as that in embodiment 1, and will not be described again. In this embodiment, the valve anchoring device 200 is no longer provided with the first anchoring arm 220 as described in embodiment 1.

Preferably, the heart valve prosthesis comprises a valve support 100, a prosthetic leaflet and a sealing membrane, and the structures of the three are the same as those in embodiment 1, and will not be described herein again. In this embodiment, the valve stent 100 is no longer provided with the waisted second connector as described in embodiment 1.

Referring to fig. 6, in a preferred embodiment, at least one row of second connecting elements is circumferentially arranged on the partially adjacent grid structure or grid structure wave bars 121 of the main body 120 of the valve stent 100, and the second connecting elements are configured as a plurality of second anchoring arms 110, preferably, the plurality of second anchoring arms 110 can be attached to the outer peripheral wall of the valve stent 100 in a compressed state of the valve stent 100, can extend toward the radial outer side of the valve stent 100 in a released state and penetrate at least into the native valve leaflets 500, and more preferably, the second anchoring arms 110 penetrate out of the native valve leaflets 500 and are stably abutted against the valve anchoring device 200.

Preferably, the second anchoring arm 110 can be made of memory alloy, polymer, fiber or other high molecular material, and is fixed to the valve stent 100 by welding, crimping or riveting; in a more preferred embodiment, the second anchoring arm 110 is made of the same material as the valve stent 100, and is integrally cut and formed; a nickel titanium alloy material is preferably used, which can ensure that the contracted state is kept in the delivery process to the human body, the valve stent 100 expands and penetrates into the valve leaflet native valve leaflet 500 after being released, and then the stable shape is kept; more importantly, the nickel-titanium alloy as a biocompatible material is safer, has the performances of wear resistance and corrosion resistance, and does not generate rejection reaction.

Optionally, the second anchoring arm 110 extends radially outward in the direction of the outflow end; preferably, the second anchoring arm 110 extends radially outwards and in the direction of the inflow end, corresponding to the mitral valve, i.e. radially obliquely upwards, forming a barb-like structure. After the second anchoring arms 110 penetrate out of the native valve leaflets 500, the second anchoring arms can abut against the lower sides of the annular members, so that the valve stent 100 and the valve anchoring device 200 are tightly combined and generate a stable anchoring force, and the valve stent 100 is prevented from being displaced in the cardiac phase.

Preferably, the angle α of the second anchoring arm 110 to the vertical is an acute angle, more preferably 30-75 °, as shown in fig. 7.

In a preferred embodiment, the second anchoring arm 110 is circular or elliptical in cross-section, and extends radially outward in a straight line shape; in another preferred embodiment, the second anchoring arm 110 extends outwardly in a generally arcuate shape, or at least a section of the second anchoring arm 110 is arcuate in shape and the curvature matches the profile of the annular member 210 to ensure stable abutment therebetween.

In other preferred embodiments, the second anchoring arm 110 may also be tilted in a clockwise or counterclockwise direction to provide a larger contact area with the annular member 210, thereby further increasing the friction force and ensuring the tightness of the combination. Alternatively, the second anchoring arms 110 disposed in the same row are inclined in the same direction, but the inclination angles may be different in order to provide more angular/radial frictional force with the valve anchoring device 200, so that the combination of the two is more stable. Preferably, the inclination directions of the second anchoring arms 110 arranged in the same row are consistent, and the inclination directions of the second anchoring arms 110 arranged in different rows may be inconsistent, so as to avoid the valve anchoring device 200 from being detached from the valve stent 100 in compliance with the inclination tendency of a certain row.

Referring to fig. 8 and 9, it is preferable that the length L of the second anchoring arm 110 is longer than the sectional diameter d of the ring member 210 regardless of whether the second anchoring arm 110 is straight or arc-shaped, in order to prevent the second anchoring arm 110 and the ring member 210 from being separated due to the movement of the myocardium; preferably, L.gtoreq.2 d.

In a preferred embodiment, the shape, size, inclination angle, etc. of the second anchoring arms 110 disposed at different positions may be the same or different from each other.

In a preferred embodiment, the second anchoring arms 110 may be disposed on a plurality of rows of grid structures and may be circumferentially symmetrical or circumferentially staggered.

More preferably, at least some sections of the annular member 210 are provided with first connectors configured with a plurality of anchoring grooves 250 having variable diameter structures, and some sections of the annular member 210 are arranged to be concave grooves or waisted shapes matched with the profile of the second anchoring arms 110, as shown in fig. 5, and the positions and the sizes of the anchoring grooves 250 are matched with the second anchoring arms 110, so that stable contact between the annular member 210 and the second anchoring arms 110 is realized, the valve anchoring device 200 and the valve support 100 are difficult to separate, and the stability of matching between the two is improved.

Referring to fig. 10 and fig. 11, in the present embodiment, the above replacement system is used in the same manner as in embodiment 1, except that: when the prosthetic heart valve is released, the second connectors of its peripheral wall are able to radially pierce the native leaflets 500 and stably abut the annular member 210.

Example 3

Still taking the example of mitral valve implantation, in this embodiment, a transcatheter heart valve replacement system is provided that also includes a prosthetic heart valve and a valve anchoring device 200.

Referring to the solutions of embodiments 1 and 2, in the present embodiment, the first anchoring arm 220 is disposed at the inner side of the valve anchoring device 200, the second anchoring arm 110 is disposed at the outer periphery of the valve stent 100, and the first anchoring arm 220 and the second anchoring arm 110 are disposed alternately, so as to achieve a multi-level stable connection between the valve anchoring device 200 and the prosthetic heart valve, so that the prosthetic heart valve is more safe and stable to fit with the native tissue structure.

In this embodiment, the first anchoring arms 220 may be circumferentially symmetrically distributed or staggered, and the second anchoring arms 110 may also be circumferentially symmetrically distributed or asymmetrically distributed, so long as the first anchoring arms 220 and the second anchoring arms 110 do not contact each other.

In a preferred embodiment, at least some sections of the ring member 210 are provided with anchoring grooves 250, and the position and size of the anchoring grooves 250 match with the second anchoring arms 110. More preferably, a waisted structure like anchoring groove 250 is also provided on some wave bars 121 of valve stent 100 to achieve a stable abutment between valve stent 100 and first anchoring arm 220.

In this embodiment, the other configurations of the heart valve prosthesis, the valve anchoring device 200 are the same as those of embodiment 1 or embodiment 2, and are not described again.

Example 4

Still taking the example of mitral valve implantation, in this embodiment, a transcatheter heart valve replacement system is provided that also includes a prosthetic heart valve and a valve anchoring device 200.

In this embodiment, the valve anchoring device 200 is still configured in a generally helical configuration and has a plurality of end-to-end annular members 210, the configuration of the annular members 210 being the same as in embodiment 1 above, but the valve anchoring device 200 is no longer provided with first anchoring arms 220 as described in embodiment 1 or anchoring slots 250 as described in embodiment 2.

In this embodiment, the prosthetic heart valve includes a valve stent 100, a prosthetic leaflet, and a sealing membrane, and the valve stent 100 is the same as that in embodiment 1, but does not have the second anchoring arm 110 as described in embodiment 2 or the waisted structure as described in embodiment 1.

As shown in fig. 12, preferably, in the present embodiment, a plurality of first connectors are disposed on the annular member 210, and the first connectors are a plurality of magnetic members 260; preferably, a plurality of second connectors are provided on the valve stent 100, the second connectors also being configured as a plurality of magnetic members 260.

In a preferred embodiment, the first and second connectors are provided for the purpose of magnetically connecting the annular member 210 to the valve holder 100, but since the annular member 210 and the valve holder 100 are preferably made of metal material, which is ferromagnetic, the magnetic attraction between the annular member 210 and the valve holder 100 can be achieved when only the first or second connectors are provided.

Preferably, the magnetic member 260 in the first connector or the second connector may be configured as a U-shaped, annular, spiral or tube shape with a pattern on the surface, and the magnetic member 260 may be sleeved and fixed on the annular member 210 or the wave rod 121 of the main body 120 by welding, crimping, riveting, or the like; preferably, when the magnetic member 260 is provided on the wave bar 121 of the main body portion 120, it is necessary to ensure that at least a portion of the segment faces radially outward to ensure that the annular member 210 can be attracted; preferably, when the magnetic member 260 is disposed on the annular member 210, at least a portion of the segment faces radially inward to ensure attraction to the valve holder 100.

Preferably, no matter what shape the magnetic member 260 is configured into, the magnetic member 260 is selectively disposed on the inner surface of the annular member 210 or the outer surface of the wave rod 121, and at least protrudes from the surfaces of the two, or the surface of the magnetic member 260 is textured, so as to ensure that the friction force between the prosthetic heart valve and the valve-anchoring device 200 can be increased while generating the magnetic attraction, and thus the stable connection between the prosthetic heart valve and the valve-anchoring device 200 can be realized.

Preferably, the magnetic member 260 is made of neodymium-iron-boron alloy, which has the features of small volume, light weight and strong magnetism, so as to provide greater magnetic attraction force.

Preferably, in the present embodiment, when the annular member 210 and the valve stent 100 are both provided with the magnetic members 260, the magnetic members 260 may be symmetrically distributed or staggered in the circumferential direction, but it is necessary to ensure that the positions are matched with each other to ensure that the annular member 210 and the valve stent 100 can attract each other.

Preferably, when only a plurality of first connectors are provided on the annular member 210, the main body portion 120 of the valve stent 100 is provided with a ferromagnetic material at least at the sections corresponding to the first connectors, and particularly, some titanium-nickel alloy having ferromagnetic property may be selected.

Preferably, when the second connector is provided only on the main body portion 120 of the valve stent 100, the annular member 210 is provided with a ferromagnetic material at least in a section corresponding to the second connector, and specifically, some nickel-titanium alloy having ferromagnetic property may be selected.

In this embodiment, the usage of the replacement system is the same as that of embodiment 1, and is not described herein again.

Example 5

Still taking the example of mitral valve implantation, in this embodiment, a transcatheter heart valve replacement system is provided that also includes a prosthetic heart valve and a valve-anchoring device 200'.

Preferably, in this embodiment, the specific arrangement of the prosthetic heart valve is the same as that of embodiment 1, and is not described herein again.

Referring to fig. 13-16, preferably, the valve anchoring device 200 'includes a plurality of closed annular members 210', with elastic connection between adjacent annular members 210', and axial parallel arrangement between adjacent annular members 210'. Preferably, the plurality of annular members 210' are not radially deformed to support, mate with and anchor the body portion 120 of the valve stent 100; while the elastic connections 230 between adjacent annular members 210 'may provide the axial deformability of the valve anchoring device 200' to conform to the morphological changes of the myocardial tissue throughout the cardiac cycle.

In a preferred embodiment, the annular member 210 'is made of a shape memory metal, preferably nitinol, and the elastic connecting member 230 is also made of a shape memory metal and is fixed to the annular member 210' by welding or crimping. The elastic connection members 230 are preferably symmetrically distributed in a plurality along the circumference of the annular member 210', and each elastic connection member 230 is parallel to the axial direction of the valve anchoring device 200'.

Preferably, the ring member 210 'can be arranged in the delivery device in a straight line shape when delivering, as shown in fig. 14, the two ends of the ring member 210' are provided with the snap structures 240, the snap structures 240 can be arranged as pins and grooves, such as the connecting structures in highline, after reaching the left ventricle 400 and releasing the ring member 210', the shape is returned to the ring shape in a straight line shape, and the snap structures 240 at the two ends are connected end to end, so as to achieve the catching of the native valve leaflet 500 by the valve anchoring device 200', as shown in fig. 15.

Preferably, the valve anchoring device 200' comprises at least two annular members 210', the distance between adjacent annular members 210' being 1.0-5.0mm; preferably, the axial length of the valve anchoring device 200' is adapted to the length of the body portion 120 of the valve stent 100; preferably, the valve anchoring device 200' has an inner diameter that is adapted to the outer diameter of the body portion 120 of the valve stent 100, as shown in fig. 16.

Further, the shape and size of the atrium/valve/ventricle may vary from patient to patient, and those skilled in the art will appreciate that the specific size of the valve anchoring device 200' and the number of annular members 210' provided may be adapted according to the patient's condition.

Preferably, the valve anchoring device 200' is provided with a first attachment means on the at least one annular member 210', which is configured as a plurality of first anchoring arms 220', preferably the plurality of first anchoring arms 220' is circumferentially arranged inside the annular member 210' and extends in the direction of the body portion 120.

Alternatively, the first anchoring arm 220' may be made of the same material as that used in embodiment 1, and will not be described herein.

Optionally, the first anchoring arm 220' extends radially inward toward a direction away from blood flow; preferably, the first anchoring arms 220 'extend radially inward and towards the blood flow-compliant direction, corresponding to the mitral valve, i.e. radially obliquely downward, forming a barb-like structure, on the one hand, the valve anchoring device 200' can move downward a certain distance under the influence of its own weight, during which movement the first anchoring arms 220 'can penetrate the native leaflets 500, so that the bonding of the valve anchoring device 200' and the native tissue is more secure; on the other hand, during the downward movement of the valve anchoring device 200', the first anchoring arm 220' is also used to limit the movement thereof, so as to achieve a good limiting effect.

Preferably, the first anchoring arm 220' is angled at an acute angle to the vertical, more preferably 30 to 75 °.

In a preferred embodiment, the first anchoring arm 220' is a flat structure, extending radially inward in a straight line shape; in another preferred embodiment, the first anchoring arm 220' extends inwardly in a generally arcuate shape; in other preferred embodiments, the first anchoring arm 220 'may also be tilted in a clockwise or counterclockwise direction to further increase the contact area between the first anchoring arm 220' and the native tissue after penetrating into the native leaflet 500, thereby further ensuring the tightness and stability of the combination of the two.

In a preferred embodiment, the length of the first anchoring arm 220' is defined as: allowing it to penetrate the native leaflets 500, but not piercing the native leaflets 500; at this time, the valve anchoring device 200' and the valve stent 100 are not in direct contact with each other, but the anchoring effect is enhanced by further increased friction therebetween.

In another preferred embodiment, the length of the first anchoring arm 220' is defined as: allowing it to pierce the native leaflets 500, but not beyond the inner wall of the prosthetic heart valve; at this time, there may be direct contact between the valve-anchoring device 200' and the valve stent 100, and there may be not only friction but also other forces therebetween. The length of the first anchoring arm 220' is set not to exceed the inner wall of the artificial heart valve, so as to prevent the first anchoring arm from puncturing the artificial valve leaflet and causing the artificial heart valve to fail.

Preferably, when the first anchoring arm 220' can pierce the native leaflet 500, its structure is configured to be substantially arc-shaped; more preferably, a second connector is provided where the valve stent 100 may abut the first anchoring arm 220', in which case the second connector may be provided as: a groove or a waisted shape matched with the profile of the first anchoring arm 220 'is arranged on the wave rod 121 at the position corresponding to the position of the first anchoring arm 220'; in particular, some of the wave bars 121 may be tapered to form a waisted structure.

It will be understood by those skilled in the art that while the first anchoring arms 220' may pierce the native leaflets 500, they do not necessarily have to abut against the wave bars 121 on the valve stent 100, but may also penetrate the sealing membrane of the valve stent 100, in which case it may be considered that there is no direct contact between the valve-anchoring device 200' and the valve stent 100, but there is direct contact between the valve-anchoring device 200' and the prosthetic heart valve. Therefore, in the present embodiment, the second connecting member is not necessarily required to be disposed, and the second connecting member may not be disposed.

In a preferred embodiment, the first anchoring arms 220 'may be disposed on a plurality of annular members 210' and may be circumferentially symmetrically distributed or circumferentially staggered.

It will be understood by those skilled in the art that, since different patients have different ages, sexes, heights, weights, lesion positions, lesion conditions, etc., in order to ensure that the heart valve replacement system can be well fitted with the native valve to function, the sizes of the prosthetic heart valve and the valve anchoring device 200' and the relative position angles thereof can be adjusted or selected adaptively, and will not be described herein again.

In the present embodiment, the method of using the above-mentioned prosthetic heart valve is as follows:

the valve anchor 200 'is, when delivered, arranged in a straight line in the delivery device, through which the valve anchor 200' is transvascularly or transapically accessed to the left ventricle 400 and delivered between the mitral chordae tendineae 600 and the wall of the left ventricle 400. The valve anchoring device 200' passes through the gap between the chordae tendineae 600 and the wall of the left ventricle 400, and surrounds the chordae tendineae 600, and the clamping structures 240 at the two ends are clamped and fixed with each other to form a complete closed ring shape, so that on one hand, the capturing of the mitral valve leaflets is realized, and on the other hand, an anchoring site is provided for the subsequent implantation of the artificial heart valve.

After release of the valve anchor 200', the first connectors on the radially inner side thereof also return to the pre-shaped configuration, i.e. extend radially inward, and penetrate into the native leaflets 500.

The artificial heart valve is compressed by the conveyor and enters the way through the femoral vein, and is released after passing through the interatrial septum and reaching the mitral valve, the main body part 120 of the valve support 100 is correspondingly arranged at the radial inner side of the valve anchoring device 200', and the skirt part 130 is correspondingly arranged at the left atrium 300 side of the mitral valve, so that the perivalvular leakage is prevented, and the operation risk is reduced.

On the one hand, when the first connector length of the valve-anchoring device 200 'can only penetrate the native leaflets 500 without piercing, there is no direct contact between the valve-anchoring device 200' and the valve stent 100, enhancing the anchoring effect by further increased friction between the two.

On the other hand, when the first connector length of the valve-anchoring device 200 'can pierce through the native valve leaflet 500, there is a possibility of direct contact between the valve-anchoring device 200' and the valve stent 100, and there is not only friction force but also other acting force between the two, and at this time, the valve stent is preferably further provided with a second connector which can be matched in shape with the first connector and stably abut against each other, so as to provide a better and stable anchoring force, prevent the valve stent 100 from being displaced during the cardiac phase, and make the artificial heart valve and the native tissue structure fit more safely and stably.

Example 6

Still taking mitral valve implantation as an example, in the present embodiment, a transcatheter heart valve replacement system is provided, which also includes a prosthetic heart valve and a valve anchoring device 200'.

Referring to fig. 17 and 18, preferably, the valve anchoring device 200' is configured as a plurality of annular members 210' arranged in parallel and closed, and the structure of the annular members 210' is the same as that in the embodiment 5, and is not repeated herein. In this embodiment, the valve anchoring device 200 'is no longer provided with the first anchoring arm 220' as described in embodiment 5.

The artificial heart valve comprises a valve support 100, artificial valve leaflets and a sealing film; preferably, the valve stent 100 is provided with a second anchoring arm 110 at the periphery thereof, and the specific arrangement of the second anchoring arm 110 may be the same as that of embodiment 2, which is not described herein again.

In this embodiment, it is more preferable that at least some sections of the annular member 210 'are provided with first connecting elements, the first connecting elements are configured with a plurality of anchoring slots 250 with variable diameter structures, and the location and size of the anchoring slots 250 are matched with the second anchoring arms 110 by arranging some sections of the annular member 210' to be concave grooves or waisted shapes matched with the profiles of the second anchoring arms 110, so as to realize stable abutment between the annular member 210 'and the second anchoring arms 110, ensure that the valve anchoring device 200' is difficult to disengage from the valve holder 100, and improve the stability of fit between the two.

Example 7

Still taking mitral valve implantation as an example, in the present embodiment, a transcatheter heart valve replacement system is provided, which also includes a prosthetic heart valve and a valve anchoring device 200'.

Referring to the solutions of embodiments 5 and 6, in this embodiment, the first anchoring arms 220 'are disposed on the inner side of the valve anchoring device 200', the second anchoring arms 110 are disposed on the outer periphery of the valve stent 100, and the first anchoring arms 220 'and the second anchoring arms 110 are disposed alternately, so as to achieve a multi-level stable connection between the valve anchoring device 200' and the artificial heart valve, so that the artificial heart valve can be matched with the native tissue structure more safely and stably.

In this embodiment, the first anchoring arms 220 'may be circumferentially symmetrically distributed or staggered, and the second anchoring arms 110 may also be circumferentially symmetrically distributed or asymmetrically distributed, so long as the first anchoring arms 220' and the second anchoring arms 110 are not in contact with each other.

In a preferred embodiment, anchoring grooves 250 are provided at least in some sections of the ring-shaped member 210', and the position and size of the anchoring grooves 250 match with the second anchoring arms 110. More preferably, a waisted structure like anchoring groove 250 is also provided on some wave bars 121 of valve stent 100 to achieve a stable abutment between valve stent 100 and first anchoring arm 220'.

Example 8

Still taking mitral valve implantation as an example, in the present embodiment, a transcatheter heart valve replacement system is provided, which also includes a prosthetic heart valve and a valve anchoring device 200'.

In the present embodiment, the structure of the valve anchoring device 200 'is the same as that in embodiment 5 described above, but the first anchoring arm 220' is not provided; the prosthetic heart valve is also not provided with the second anchoring arm 110.

Preferably, in this embodiment, a plurality of first connectors are provided on the ring member 210', and the first connectors are a plurality of magnetic members 260; preferably, a plurality of second connectors are provided on the valve stent 100, the second connectors also being configured as a plurality of magnetic members 260.

In a preferred embodiment, the first and second connectors are provided for the purpose of magnetic connection between the annular member 210' and the valve holder 100, but since the annular member 210' and the valve holder 100 are preferably made of metal material, and can be ferromagnetic, magnetic attraction between the annular member 210' and the valve holder 100 can be achieved when only the first or second connectors are provided.

Preferably, the surface of the magnetic member 260 is provided with texture, so as to ensure that the friction force between the prosthetic heart valve and the valve anchoring device 200 'can be increased while generating magnetic attraction, and thus, the stable connection between the prosthetic heart valve and the valve anchoring device 200' is realized.

Preferably, in this embodiment, the specific arrangement manner of the magnetic member 260 is the same as that of embodiment 4, and is not described herein again.

While the present invention has been described with reference to the embodiments shown in the drawings, the present invention is not limited to the embodiments, which are illustrative and not restrictive, and it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention as defined in the appended claims.

Claims (19)

1. A transcatheter heart valve replacement system comprising a prosthetic heart valve and a valve anchoring device;

the valve anchoring device comprises at least one annular member; the valve anchoring device is positionable outside native valve chordae tendineae and conforms to changes in the native annulus morphology;

the prosthetic heart valve includes a valve holder including a body portion defining a flow channel for the flow of blood therethrough; the prosthetic heart valve is positionable inside the native valve and replaces the physiological function of the native valve;

the annular member is provided with a first connector having a tendency to extend towards the main body portion, the first connector piercing or not piercing native leaflets and cooperating with the main body portion;

and/or the body portion is provided with a second connector having a tendency to extend towards the annular member, the second connector either piercing or not piercing the native leaflets and co-operating with the annular member.

2. The transcatheter heart valve replacement system of claim 1, wherein the valve anchoring device comprises a plurality of the annular members, adjacent annular members being joined end-to-end in a helical configuration.

3. The transcatheter heart valve replacement system of claim 1, wherein the valve anchoring device comprises a plurality of the annular members, each of the annular members having a closed loop shape, the plurality of annular members being axially arranged in parallel and resiliently connected between adjacent annular members.

4. The transcatheter heart valve replacement system of claim 2 or 3, wherein at least a portion of the annular member has an axial length that is adapted to an axial length of the body portion and/or wherein at least a portion of the annular member has an inner diameter that is adapted to an outer diameter of the body portion.

5. The transcatheter heart valve replacement system of claim 1, wherein the main body portion is in the form of a mesh tube having a plurality of interconnected polygonal mesh structures.

6. The transcatheter heart valve replacement system of claim 5, wherein the valve stent further comprises a skirt portion; the skirt part is of a flange disc-shaped structure, and the small-diameter end of the skirt part is connected with the main body part.

7. The transcatheter heart valve replacement system of claim 1, wherein the first connector includes a plurality of first anchoring arms disposed inboard of at least a portion of the annular member and extending radially inward.

8. The transcatheter heart valve replacement system of claim 7, wherein the first anchoring arm is straight or arcuate;

the first anchoring arm is bent away from the blood flow; alternatively, the first anchoring arm is bent toward a direction compliant with blood flow.

9. The transcatheter heart valve replacement system of claim 1, wherein the first connector includes a plurality of anchor slots disposed inside at least a portion of the annular member, the anchor slots having a profile that conforms to the second connector.

10. The transcatheter heart valve replacement system of claim 9, wherein the anchoring slot includes a variable diameter section disposed on the annular member, the variable diameter section being waisted.

11. The transcatheter heart valve replacement system of claim 1, wherein the first connector comprises a plurality of magnetic members disposed on the annular member in a U-shape, an annular shape, or a spiral shape with at least some segments facing radially inward of the annular member.

12. The transcatheter heart valve replacement system of any one of claims 7-11, wherein a plurality of the first connectors are circumferentially symmetrically distributed on an inner side of at least a portion of the annular member; alternatively, the first and second electrodes may be,

the first connecting pieces are circumferentially distributed on the inner side of at least part of the annular component in a staggered mode.

13. The transcatheter heart valve replacement system of claim 1, wherein the second connector includes a plurality of second anchoring arms disposed outside of the body portion, the second anchoring arms being straight or arcuate; the second anchoring arms are configured to extend radially outward when the valve stent is expanded.

14. The transcatheter heart valve replacement system of claim 13, wherein the second anchoring arm is bent away from blood flow; alternatively, the second anchoring arm is bent toward a direction compliant with blood flow.

15. The transcatheter heart valve replacement system of claim 13, wherein a length of the second anchoring arm is greater than a cross-sectional diameter of the annular member.

16. The transcatheter heart valve replacement system of claim 5, wherein the second connector includes a plurality of variable diameter sections disposed on the lattice structure, the variable diameter sections being waisted.

17. The transcatheter heart valve replacement system of claim 5, wherein the second connector comprises a plurality of magnetic members disposed on the lattice structure in a U-shape, an annular shape, or a spiral shape with at least some segments facing radially outward of the body portion.

18. The transcatheter heart valve replacement system of any one of claims 13-17, wherein the plurality of second connectors are circumferentially symmetrically disposed on an outer side of the body portion; alternatively, the first and second electrodes may be,

the plurality of second connecting pieces are circumferentially distributed on the outer side of the main body part in a staggered manner.

19. The transcatheter heart valve replacement system of claim 1, wherein the first connector comprises a metal or other hard polymeric material, the first connector being affixed to or integrally formed with the annular member;

and/or the second connecting piece comprises metal or other hard high polymer materials, and the second connecting piece is fixedly connected with the main body part or integrally formed.

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