CN117462304A - Prosthetic heart valve and transcatheter heart valve replacement system - Google Patents

Abstract

The invention relates to a prosthetic heart valve and a transcatheter heart valve replacement system, wherein the prosthetic heart valve comprises a valve support, the valve support comprises a first sub-support and a second sub-support, the first sub-support is provided with an inflow section, a first main body section and an outflow section, the proximal end of the inflow section is provided with a delivery connecting piece, the first main body section is in a net pipe shape, and the outflow section is in a flaring shape; the second sub-support is provided with a skirt edge section, a second main body section and a support connecting section, wherein the skirt edge section is in a flange disc shape, the second main body section comprises a plurality of straight support rods which are longitudinally arranged, and the end part of the support connecting section is fixedly connected with the end part of the outflow section. The artificial heart valve provided by the invention can be anchored at the annulus more firmly, so that medical accidents are avoided, the total length is shorter, the artificial heart valve is convenient to convey to the mitral valve or the tricuspid valve through a vascular access, in addition, the blood flow dynamics performance is more excellent, the effective orifice area is larger, and the problem that a delivery connecting piece arranged at the proximal end can block blood outflow is avoided.

Description

Prosthetic heart valve and transcatheter heart valve replacement system

Technical Field

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

Background

A prosthetic heart valve is a medical device used to treat heart valve disease that can replace a dysfunctional or damaged native valve and restore normal blood flow to the heart.

Prosthetic heart valves are typically made of biological or synthetic materials, of four types: mitral valve, aortic valve, tricuspid valve and pulmonary valve. Wherein, mitral Valve (Mitral Valve) is located between left atrium and left ventricle, and tricuspid Valve (Tr icuspid Valve) is located between right atrium and right ventricle. The common artificial mitral valve or artificial tricuspid valve consists of a metal bracket, artificial valve leaves, a sealing membrane and other structures, is released after passing through the apex of the heart to a target implantation position through a catheter to replace a heart valve of a patient, recovers normal heart blood flow direction, and simultaneously needs to ensure that the artificial valve can be anchored at the heart valve of the patient and avoid paravalvular leakage.

Although transcatheter prosthetic heart valve replacement has grown in recent years, the prosthetic heart valves of the prior art have problems:

1) The anchoring mechanism of the valve stent is not reliable enough, the anchoring capability is weak, and the stability of the artificial valve at the valve annulus cannot be completely ensured;

2) The skirt section of the valve outer bracket has poor compliance and cannot be completely attached to the atrial wall, and meanwhile, the main section of the valve outer bracket is not easy to deform, so that the artificial heart valve cannot be completely attached to the annulus and the ventricular wall;

3) The diameter of the valve inner stent is smaller, the area of the orifice is smaller, and the hemodynamic performance is poorer;

4) The valve stent of the prior art is longer in length and the hard segment of the delivery device is longer, resulting in less easy handling during trans-femoral delivery in the body.

Disclosure of Invention

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

The invention adopts the following technical scheme:

in one aspect, the present invention provides a prosthetic heart valve comprising a valve stent comprising a first sub-stent and a second sub-stent sleeved outside thereof, both being radially collapsible and expandable;

the first sub-stent controls the unidirectional flow of blood through a covering film and valve blades which are arranged on the inner side, and the first sub-stent is sequentially provided with an inflow section, a first main body section and an outflow section from the proximal end to the distal end;

the second sub-stent is used for anchoring the artificial heart valve at the native valve annulus and is sequentially provided with a skirt edge section, a second main body section and a stent connecting section from the proximal end to the distal end;

the outflow section is flaring, and the support connecting section is necking, and the outflow section and the support connecting section are mutually abutted and fixed so as to reduce the axial length of the valve support.

As a preferred technical solution, the first body section is in the form of a mesh tube for providing a blood flow channel;

the first body section comprises a plurality of rows of grid structures, and adjacent grid structures among the rows are connected in a staggered manner.

As a preferred technical solution, the surface of the first main body section is provided with a plurality of petals She Feng, each petal She Feng is provided with a plurality of suture holes, and the leaflets can be fixed on the suture holes by sutures.

As a preferred solution, the inflow segment has the same diameter as the first body segment, and the inflow segment is circumferentially provided with at least two delivery connectors extending proximally for releasable connection with a valve delivery device delivered via a vascular access.

As the preferable technical scheme, the small diameter end of the outflow section is connected with the first main body section, the large diameter end of the outflow section is flared outwards in the radial direction and then extends towards the far end in the axial direction, the end part of the support connecting section is closed inwards in the radial direction and extends towards the far end in the axial direction, and the large diameter end of the outflow section is abutted against the end part of the support connecting section and is fixedly connected with the end part of the support connecting section.

As the preferable technical scheme, the far end of the outflow section is provided with a frame-shaped structure, and the end part of the bracket connecting section is embedded in the frame-shaped structure and fixedly connected.

As the preferable technical scheme, the support connecting section comprises a plurality of Y-shaped structures which are circumferentially arranged, each Y-shaped structure comprises a vertical rod and two inclined rods, the inclined rods and the proximal ends of the vertical rods are in a closing-in shape and extend, and at least the end parts of the distal ends of the vertical rods extend axially and are embedded in the frame-shaped structures.

As a preferred technical solution, the second body section comprises a plurality of longitudinally arranged straight support bars arranged parallel to each other for adapting to the contour of the native annulus;

the radial support force of the second body section is less than the radial support force of the bracket connection section.

As the preferable technical scheme, the V-shaped connecting rods are arranged between the adjacent straight supporting rods, the two end parts of the V-shaped connecting rods are respectively fixed on the adjacent straight supporting rods, and the V-shaped connecting rods can radially expand and be jointed with the native valve leaflet tissues after the valve stent is released.

As a preferred solution, the second body section is provided with at least one row of V-shaped connecting rods, each row of V-shaped connecting rods being configured to be circumferentially continuous or spaced apart.

As a preferred technical scheme, the skirt section is in a flange shape and is used for being attached to the atrial wall;

the skirt edge section comprises a plurality of herringbone connecting structures and elastic supporting pieces, one end of each herringbone connecting structure is connected with the proximal end of the second main body section, and the other end of each herringbone connecting structure is connected with the distal end of each elastic supporting piece;

the elastic support is configured as a folded-back structure formed by bending the elongated structure back and forth in a direction intersecting the axial direction.

As a preferred technical solution, the folded back structure comprises a plurality of axially connected S-shaped structures;

alternatively, the fold-back structure comprises a plurality of link structures;

alternatively, the return structure comprises a spring structure.

As a preferred embodiment, the first sub-stent and the second sub-stent each comprise a shape memory material.

In another aspect, the present invention also provides a transcatheter heart valve replacement system comprising:

the prosthetic heart valve of any one of the above;

a valve delivery mechanism, the distal end of the valve delivery mechanism being releasably connectable with the proximal end of the prosthetic heart valve, the valve delivery mechanism being capable of delivering and releasing the prosthetic heart valve to a preset location via the vascular access.

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

the invention mainly provides a prosthetic heart valve suitable for mitral valve or tricuspid valve replacement, wherein the main structure of a valve support comprises a first sub-support on the inner side and a second sub-support on the radial outer side, the first sub-support and the second sub-support are fixedly connected at the outflow end, and the first sub-support and the second sub-support can be radially expanded after being released.

The channel defined in the first sub-support can control unidirectional flow of blood, the proximal end of the channel is provided with a delivery connecting piece, the distal end of the channel is in a flaring shape, and the channel is combined with the closing structure of the support connecting section of the second sub-support, so that on one hand, the total length of the valve support is shorter, the valve support is beneficial to conveying a prosthetic heart valve to a mitral valve or a tricuspid valve position through a blood vessel, on the other hand, the blood flow dynamics performance is more excellent, the effective flap opening area is larger, and the delivery connecting piece arranged at the proximal end does not need to worry that the blood flows out.

The outside second sub-support can perfectly laminate the mitral valve annulus, and the second main body section does not adopt a grid structure, but uses a plurality of straight support rods which are axially arranged in parallel, so that the second main body section is easier to deform to better adapt to the outline of the mitral valve annulus, and in addition, the skirt section is provided with a plurality of elastic support pieces, so that the mitral valve annulus can be completely laminated with the atrial wall. Although the second sub-stent has good compliance, since the second sub-stent has a significantly larger size than the first sub-stent, the size or function of the blood flow channel defined within the first sub-stent is not affected even if the second sub-stent is compressed by the annulus.

Further, the radial supporting force of the second main body section of the second sub-support is smaller than the radial supporting force of the support connecting section, so that the second sub-support can be in a rough 'gourd-shaped' structure after being implanted, the second sub-support has a larger perimeter size compared with an annulus, the second sub-support is matched with the V-shaped connecting rod which is arranged on the second main body section and protrudes outwards in the radial direction, the valve support can have more stable anchoring capacity, the artificial heart valve can be firmly anchored at the annulus, and medical accidents caused by displacement of the artificial heart valve in the heart are avoided.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the description of the embodiments are briefly described below to form a part of the present invention, and the exemplary embodiments of the present invention and the description thereof illustrate the present invention and do not constitute undue limitations of the present invention. In the drawings:

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

FIG. 2 is a schematic view showing the structure of a first sub-mount according to a preferred embodiment of the present invention disclosed in example 1;

FIG. 3 is a schematic view showing the structure of a second sub-mount according to a preferred embodiment of the present invention disclosed in example 1;

FIG. 4 is a schematic view of the end of the bracket connection section according to a preferred embodiment of the invention disclosed in example 1;

FIG. 5 is a schematic view showing the structure of the second sub-stent before implantation in accordance with the preferred embodiment of the present invention disclosed in example 1;

FIG. 6 is a schematic view showing the structure of a second sub-stent after implantation in accordance with the preferred embodiment of the present invention as disclosed in example 1;

FIG. 7 is a schematic view of the structure of an inner stent and an outer stent of a valve stent of the prior art;

fig. 8 is a schematic structural view of a first sub-mount and a second sub-mount according to a preferred embodiment of the present invention disclosed in example 1.

Reference numerals illustrate:

the first sub-stent 10, inflow segment 11, delivery connector 111, first main body segment 12, flap She Feng junction 121, outflow segment 13, connecting rod 131, frame-like structure 132, second sub-stent 20, skirt segment 21, return structure 212, second main body segment 22, straight support bar 221, v-shaped connecting rod 222, stent connector segment 23, vertical bar 231, inner stent 30, outer stent 40.

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 specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be 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 explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; the magnetic connection can be mechanical connection or magnetic connection; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by 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 merely to distinguish between descriptions and are not to be construed as indicating or implying relative importance.

In the technical field of interventional medical devices, the position close to the operator is generally defined as the proximal end, and the position far from the operator is defined as the distal end. The direction of the central axis of the cylinder, the pipe body and the like is defined as the axial direction. Radial refers to a direction through the central axis in a radial plane, e.g., a straight direction along a diameter or radius, or a straight direction perpendicular to the central axis.

It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

To solve the problems existing in the prior art, the embodiments of the present application provide a prosthetic heart valve, including a valve stent, where the valve stent includes a first sub-stent 10 and a second sub-stent 20 sleeved outside the first sub-stent, both of which can radially collapse and expand; the first sub-stent 10 controls the unidirectional flow of blood through a covering film and valve blades arranged on the inner side, and the first sub-stent 10 is sequentially provided with an inflow section 11, a first main body section 12 and an outflow section 13 from the proximal end to the distal end; the proximal end of the inflow segment 11 is provided with a delivery connector 111 for releasable connection with a valve delivery mechanism; the first main body section 12 is in a net pipe shape and is used for providing a blood flow channel; the outflow section 13 is flared and fixedly connected with the second sub-bracket 20; the second sub-stent 20 is used for anchoring the prosthetic heart valve at the native valve annulus, the second sub-stent 20 is sequentially provided with a skirt section 21, a second main body section 22 and a stent connecting section 23 from the proximal end to the distal end, and the skirt section 21 is in a flange shape and is used for being attached to the atrial wall; the second body section 22 comprises a plurality of longitudinally arranged straight support bars 221, the straight support bars 221 being arranged parallel to each other for adapting to the contour of the native annulus; the end of the bracket connecting section 23 is in a closing shape and is fixedly connected with the end of the flaring outflow section 13 so as to reduce the axial length of the valve bracket.

Example 1

To solve the problems of the prior art, the present embodiment provides a prosthetic heart valve, preferably for mitral or tricuspid valve replacement.

1-8, a prosthetic heart valve includes a valve stent, a sealing membrane, and a prosthetic leaflet, wherein the valve stent is capable of radially collapsing upon delivery, radially expanding upon release, the expanded valve stent being capable of anchoring at an annulus and providing a passageway for blood flow; the sealing film is covered on the valve support and used for preventing paravalvular leakage; the artificial valve leaflet is used for replacing the physiological function of the original valve leaflet, and ensures the unidirectional flow of blood.

The proximal end of the valve stent is a blood inflow end, the distal end is a blood outflow end, the valve stent comprises a first sub-stent 10 and a second sub-stent 20 sleeved outside the first sub-stent, and the first sub-stent 10 and the second sub-stent 20 are fixedly connected at the distal end, as shown in fig. 1, wherein a channel for blood circulation is defined inside the first sub-stent 10, the blood unidirectional flow is controlled through a covering film and artificial valve leaflets arranged inside the first sub-stent, and the second sub-stent 20 is used for anchoring the artificial heart valve at a native valve annulus to avoid displacement or falling of the artificial heart valve.

Preferably, both the first sub-stent 10 and the second sub-stent 20 are made of shape memory material, capable of automatically recovering to an in vitro pre-formed shape after release at the annulus; preferably, the shape memory material is selected from nickel titanium alloy or copper aluminum nickel alloy.

The artificial valve is made of commercial porcine aortic valve, bovine pericardium valve or porcine pericardium valve or made of polymer material with biocompatibility, and is used for replacing the physiological function of the original valve; preferably, the artificial flap She Fengzhi is on the inside of the first sub-stent 10.

The cover may optionally cover at least a portion of the first sub-stent 10 and/or the second sub-stent 20 for preventing perivalvular leakage.

As shown in fig. 2-3, preferably, the first sub-stent 10 is sequentially provided with an inflow segment 11, a first main body segment 12 and an outflow segment 13 from the proximal end to the distal end, the second sub-stent 20 is sequentially provided with a skirt segment 21, a second main body segment 22 and a stent connecting segment 23 from the proximal end to the distal end, wherein the inflow segment 11 can be releasably connected with a delivery mechanism, so that the whole prosthetic heart valve can be delivered through a vascular passageway, the end part of the outflow segment 13 is fixedly connected with the end part of the stent connecting segment 23, so as to realize the connection between the first sub-stent 10 and the second sub-stent 20, the skirt segment 21 can be attached to the atrial wall, and the second main body segment 22 can be attached to the inner side of an annulus.

Preferably, the second body segment 22 has a diameter that is substantially larger than the first body segment 12 to ensure that when the second body segment 22 is deformed by the valve annulus compression, no further compression affects the size of the first body segment 12, ensuring structural stability of the blood flow passageway.

The dimensions or proportions of the second body section 22 and the first body section 12 may be adjusted to the actual situation, subject to different pathological basis and physiological differences in different patients, but at least it is ensured that the second body section 22 remains in a larger gap with the first body section 12 while not abutting it.

It will be appreciated by those skilled in the art that the mitral valve annulus contour shape is not symmetrical and uniform, but rather exhibits a non-circular D shape or kidney-like shape, with the tricuspid valve circumference being more complex and irregular than the mitral valve, generally exhibiting a triangular or oval shape; this unpredictability of the mitral and tricuspid valves makes it difficult to design a valve stent that is fully contoured to the annulus, which if not fully contoured may leave gaps between the prosthetic heart valve and the native annulus, resulting in blood flowing back to the atrium through these gaps, creating paravalvular leaks. In the prior art, the main body section structure of the outer support of the valve support is often configured into a grid structure, and the structure has stronger structural strength after being released, so that the valve support is difficult to adapt to an irregular annular contour.

In a preferred embodiment, the second body section 22 comprises a plurality of longitudinally disposed straight support bars 221 without further provision of cross bars or diagonal bars in the longitudinal straight support bars 221, further, adjacent straight support bars 221 are disposed parallel to each other, the plurality of parallel axially disposed straight support bars 221 providing better compliance to adapt to the contour of the native annulus when the second body section 22 is radially compressed by the annulus, ensuring that the second sub-stent 20 fully conforms to the ventricle wall under compression of the annulus.

Preferably, the plurality of straight support rods 221 are circumferentially equidistantly distributed to ensure more uniform and stable stress, and optionally, the size, number and spacing of the straight support rods 221 may be adjusted according to practical situations, which is not particularly limited herein.

Preferably, the circumference of the second body section 22 is larger than the circumference of the annulus to ensure that the annulus can squeeze the second body section 22, with the interaction force, ensuring stability of the valve holder position and preventing it from shifting.

Preferably, the radial support force of the second body section 22 is smaller than the radial support force of the bracket connection section 23, or the structural stability of the second body section 22 is smaller than the structural stability of the bracket connection section 23. Before the valve stent is implanted into the annulus, as shown in fig. 5, after the valve stent is implanted into the annulus, the second main body section 22 is extruded to radially contract, but the stent connecting section 23 has larger radial supporting force and stable structure, and at this time, the second sub-stent 20 integrally forms a 'gourd-shaped' waisted structure, as shown in fig. 6, so that the valve stent is more firmly clamped at the annulus.

As shown in fig. 3, in order to further enhance the anchoring effect of the valve stent, V-shaped connecting rods 222 are provided between adjacent straight support rods 221, and two ends of each V-shaped connecting rod 222 are respectively fixed on the adjacent straight support rods 221, and each V-shaped connecting rod 222 can collapse and be coplanar with the adjacent straight support rods 221 when the valve stent is delivered, can radially expand and penetrate into the native tissue after the valve stent is released, or can cover and clamp the valve leaflet tissue of the patient after the valve stent is released, so that the valve stent is prevented from being shifted due to pushing up the valve leaflet tissue in the systolic period, and in addition, the length of valve leaflets can be shortened after the V-shaped connecting rods 222 cover the valve leaflet tissue, so that the blood flow of an outflow channel is prevented from being influenced.

Preferably, the V-shaped connecting rod 222 extends towards the atrial side after expansion to form a generally barb-like structure, but has a larger contact area with native tissue than barbs, which can increase anchoring or coating of leaflet tissue, and when the ventricle is contracting to pump blood, the valve stent is squeezed to have a tendency to move towards the atrial side, and due to the presence of the V-shaped connecting rod 222, the tendency of the valve stent to move can be prevented, ensuring the stability of the position of the valve stent throughout the cardiac cycle.

Specifically, when the V-shaped connecting rod 222 radially expands, an included angle exists between the plane in which it is located and the straight supporting rod 221, and the included angle is an acute angle.

Preferably, the second body section 22 is provided with at least one row of V-shaped connecting rods 222, each row of V-shaped connecting rods 222 being configured to be circumferentially continuous or spaced apart, and when configured to be circumferentially continuous, each row of V-shaped connecting rods 222 forming a continuous zigzag-like structure.

In a preferred embodiment, the second body section 22 is provided with 2 to several rows of V-shaped connecting rods 222, each row of V-shaped connecting rods 222 being configured to be circumferentially continuous.

In a preferred embodiment, the second body section 22 is provided with 2 to several rows of V-shaped connecting rods 222, each row of V-shaped connecting rods 222 being configured to be circumferentially spaced apart, and adjacent rows of V-shaped connecting rods 222 being disposed in a spaced apart relationship, while reducing the compression volume of the second body section 22 while also ensuring uniform stress on the second body section 22.

It should be noted that, in the above embodiment, the radial supporting force of the second main body section 22 is configured to be smaller than the radial supporting force of the stent connecting section 23, the second sub-stent 20 is configured with a larger circumference compared to the annulus, and the V-shaped connecting rod 222 is disposed on the second main body section 22, so that the anchoring performance of the valve stent can be improved, but when the valve stent is specifically disposed, one or three of the above embodiments may be optionally disposed at the same time, and particularly when the above three embodiments are disposed at the same time, the cooperation of the three can provide the valve stent with the most excellent anchoring performance.

Preferably, as shown in fig. 3, the skirt section 21, when released, has a generally flange-like shape and comprises a plurality of "chevron" shaped connecting structures, one end of which connects to the proximal end of the second body section 22 and the other end of which connects to the distal end of the resilient support, and a resilient support; preferably, the resilient support is configured as a return structure 212 of elongate structure folded back and forth in a direction intersecting the axial direction, the return structure 212 being adapted to provide a higher compliance to ensure a better conformation of the skirt segment 21 to the atrial wall, avoiding paravalvular leakage.

In one preferred embodiment, the fold-back structure 212 comprises a plurality of axially connected S-shaped structures, in another preferred embodiment, the fold-back structure 212 comprises a plurality of link structures, and in some other preferred embodiments, the fold-back structure 212 comprises a spring structure.

Alternatively, the folded back structure 212 may be provided with only an S-shaped structure, or may be provided with only a link structure or a spring structure, or may be alternately arranged.

Preferably, the second sub-support 20 is fixedly connected with the outflow section 13 of the first sub-support 10 through a support connecting section 23 at the distal end thereof, preferably, the support connecting section 23 is in a convergent shape, the outflow section 13 is in a flaring shape, and finally, the two sections are abutted, and the fixed connection is realized through welding, riveting or bonding and the like.

In the prior art, a larger gap exists between the inner support 30 and the outer support 40, so that the outflow end of the outer support 40 is required to be set to be in a closed shape, the design can cause the overall length of the valve support to be too long, the length of the artificial heart valve in the conveying process is too long, the trafficability is reduced, and the artificial heart valve cannot be conveyed into the heart through a vascular access; in the preferred embodiment, the inner outflow section 13 is formed into a flared shape, the outer stent-connecting section 23 is formed into a necked-in shape, and the two sections are abutted and fixed, which corresponds to distributing the length of the necked-in opening of the outflow end of the outer stent 40 to the outflow end of the inner stent 30, so that the total length of the valve stent can be made shorter, and the valve stent is beneficial for the delivery of the artificial heart valve to the mitral valve or tricuspid valve through the vascular access, particularly the femoral vein, with reference to fig. 8. Furthermore, the hemodynamic performance can be improved by providing the outflow section 13 in a flared shape.

In a preferred embodiment, the support connection section 23 includes a plurality of circumferentially arranged Y-shaped structures, each Y-shaped structure including a vertical rod 231 and two diagonal rods, the diagonal rods extending in a convergent manner from the proximal end of the vertical rod 231, at least the distal end of the vertical rod 231 extending axially for fixed connection with the end of the outflow section 13.

Alternatively, the cross-sectional dimensions of the vertical bar 231 and the diagonal bar in the Y-shaped structure are the same as or different from the cross-sectional dimensions of the straight support bar 221 of the second body section 22, and the Y-shaped structure is cut or welded integrally with the straight support bar 221.

In a preferred embodiment, the small diameter end of the outflow section 13 is connected to the first body section 12, the large diameter end of the outflow section 13 has a plurality of connecting rods 131, the connecting rods 131 are flared radially outwards and then extend axially distally, the axially extending region abuts the end of the bracket connection section 23, and the two are fixedly connected.

As shown in fig. 2-4, preferably, the end of the connecting rod 131 of the outflow section 13 is provided with a frame structure 132, the distal end of the vertical rod 231 of the bracket connecting section 23 is embedded in the frame structure 132 and fixedly connected, preferably, the distal end of the vertical rod 231 is matched with the frame structure 132 in size, and after the two are embedded, more welding spots are formed, and then laser welding is performed, so that the two are more firmly connected.

Preferably, the number of the connecting rods 131 of the outflow section 13 is matched with and fixedly connected with the number and the arrangement positions of the vertical rods 231 of the bracket connection section 23 one by one.

Preferably, the first body section 12 is mesh-like and includes a plurality of rows of lattice structures, with adjacent lattice structures being connected in staggered relation. The mesh structure is more stable and less prone to deformation than the straight support rods 221 of the second body segment 22 to maintain a circular cross-section, without affecting the size or function of the blood flow passageway defined within the first body segment 12 even if the second body segment 22 is compressed by the annulus.

In a preferred embodiment, the shape memory alloy material is processed by a process including, but not limited to, braiding, laser cutting, welding, rivet connection, threaded connection, etc., to form a multi-row interconnected lattice structure, wherein the lattice structure may be configured as a diamond-shaped lattice or a hexagonal-shaped lattice; preferably, both the upper and lower opposite corners of the grid structure are V-shaped.

Specifically, the specific size of the grid in the grid structure can be freely adjusted according to actual needs, and is not limited herein.

Preferably, the surface of the first body segment 12 is provided with three petals She Feng points 121, each petal She Feng point 121 being provided with a plurality of suture holes to which the leaflets can be secured by sutures.

Preferably, the proximal end of the inflow segment 11 is provided with a delivery connector 111 for releasable connection with a valve delivery mechanism. Because the delivery connector 111 of the traditional valve stent is arranged at the outflow end of blood, the blood flow can be influenced, and the blockage is caused, when the delivery connector 111 is arranged at the inflow end of blood flow, the artificial heart valve can be delivered into a patient body through the thigh, and the outflow of blood from the artificial heart valve can not be influenced.

Preferably, the inflow segment 11 is of the same diameter as the first body segment 12, and the inflow segment 11 is circumferentially provided with at least two delivery connectors 111, the delivery connectors 111 extending proximally and being releasably connectable to a valve delivery device delivered via a vascular access.

Compared with the existing artificial heart valve, the artificial heart valve provided by the embodiment can be anchored at the annulus more firmly, the artificial heart valve is prevented from being shifted in the heart to cause medical accidents, the total length is shorter, the artificial heart valve is convenient to convey to the mitral valve or the tricuspid valve through a vascular access, in addition, the blood flow dynamics performance is more excellent while the outflow channel is not influenced, the effective flap opening area is larger, and the blood outflow is not blocked by the delivery connecting piece 111 arranged at the inflow end.

Example 2

In this embodiment, a transcatheter heart valve replacement system is provided, which includes the prosthetic heart valve of embodiment 1 and a valve delivery device, and the technical features included in the foregoing embodiment are naturally inherited in this embodiment and are not described in detail herein.

Preferably, the distal end of the valve delivery mechanism is releasably connectable with the proximal end of the prosthetic heart valve, the valve delivery mechanism being capable of delivering and releasing the prosthetic heart valve to a preset location via a vascular access.

In particular, the specific structure of the valve delivery mechanism may refer to any of the embodiments disclosed in the prior art and is not specifically limited herein.

The embodiments of the present invention have been described above with reference to the accompanying drawings, but the present invention is not limited to the above-described embodiments, which are merely illustrative and not restrictive, and many forms may be made by those having ordinary skill in the art without departing from the spirit of the present invention and the scope of the claims, which are to be protected by the present invention.

Claims (14)

1. A prosthetic heart valve comprising a valve stent comprising a first sub-stent and a second sub-stent sleeved outside the first sub-stent, both being radially collapsible and expandable;

the first sub-stent controls the unidirectional flow of blood through a covering film and valve leaflets arranged on the inner side, and the first sub-stent is sequentially provided with an inflow section, a first main body section and an outflow section from the proximal end to the distal end;

the second sub-stent is used for anchoring the artificial heart valve at the native valve annulus, and is sequentially provided with a skirt section, a second main body section and a stent connecting section from the proximal end to the distal end;

the outflow section is flaring, the support connecting section is necking, and the outflow section and the support connecting section are mutually abutted and fixed so as to reduce the axial length of the valve support.

2. The prosthetic heart valve of claim 1, wherein the first body segment is mesh-tubular for providing a blood flow passageway;

the first main body section comprises a plurality of rows of grid structures, and the adjacent grid structures among the rows are connected in a staggered manner.

3. The prosthetic heart valve of claim 1, wherein the surface of the first body segment is provided with a plurality of petals She Feng, each of the petals She Feng being provided with a plurality of suture holes to which the leaflets can be secured by sutures.

4. The prosthetic heart valve of claim 1, wherein the inflow segment is the same diameter as the first body segment, the inflow segment being circumferentially provided with at least two delivery connectors extending proximally, releasably connectable to a valve delivery device delivered via a vascular access.

5. The prosthetic heart valve of claim 1, wherein the small diameter end of the outflow segment is connected to the first body segment, the large diameter end of the outflow segment flares radially outward and then extends axially distally, the end of the stent-graft segment flares radially inward and extends axially distally, and the large diameter end of the outflow segment abuts the end of the stent-graft segment and is fixedly connected thereto.

6. The prosthetic heart valve of claim 5, wherein the distal end of the outflow segment is provided with a frame-like structure, and the end of the stent-attachment segment is embedded within and fixedly attached to the frame-like structure.

7. The prosthetic heart valve of claim 6, wherein the stent-graft segment comprises a plurality of circumferentially disposed Y-shaped structures, each of the Y-shaped structures comprising a vertical stem and two diagonal stems extending in a convergent manner from a proximal end of the vertical stem, at least an end of a distal end of the vertical stem extending axially and being embedded within the frame-like structure.

8. The prosthetic heart valve of claim 1, wherein the second body segment comprises a plurality of longitudinally disposed straight support bars disposed parallel to one another for conforming to the contour of a native annulus;

the radial supporting force of the second main body section is smaller than the radial supporting force of the bracket connecting section.

9. The prosthetic heart valve of claim 8, wherein V-shaped connecting rods are disposed between adjacent ones of the straight support rods, the V-shaped connecting rods being secured at each end to the adjacent straight support rods, the V-shaped connecting rods being capable of radially expanding and engaging native leaflet tissue upon release of the valve stent.

10. The prosthetic heart valve of claim 9, wherein the second body segment is provided with at least one row of the V-shaped connecting rods, each row of the V-shaped connecting rods configured to be circumferentially continuous or spaced apart.

11. The prosthetic heart valve of claim 1, wherein the skirt section is flange-shaped for conforming to an atrial wall;

the skirt edge section comprises a plurality of herringbone connecting structures and an elastic supporting piece, one end of each herringbone connecting structure is connected with the proximal end of the second main body section, and the other end of each herringbone connecting structure is connected with the distal end of the elastic supporting piece;

the elastic support is configured as a folded-back structure formed by bending back and forth the elongated structure in a direction intersecting the axial direction.

12. The prosthetic heart valve of claim 11, wherein the return structure comprises a plurality of axially connected S-shaped structures;

alternatively, the fold-back structure comprises a plurality of link structures;

alternatively, the return structure comprises a spring structure.

13. The prosthetic heart valve of claim 1, wherein the first subframe and the second subframe each comprise a shape memory material.

14. A transcatheter heart valve replacement system, comprising:

the prosthetic heart valve of any one of claims 1-13;

a valve delivery mechanism having a distal end releasably connectable to a proximal end of the prosthetic heart valve, the valve delivery mechanism being capable of delivering and releasing the prosthetic heart valve to a preset location via a vascular access.