CN111772879B

CN111772879B - An artificial heart valve

Info

Publication number: CN111772879B
Application number: CN202010680139.0A
Authority: CN
Inventors: 请求不公布姓名
Original assignee: Shanghai Zhenyi Medical Technology Co ltd
Current assignee: Shanghai Zhenyi Medical Technology Co ltd
Priority date: 2020-07-15
Filing date: 2020-07-15
Publication date: 2024-11-26
Anticipated expiration: 2040-07-15
Also published as: CN111772879A

Abstract

The invention discloses a prosthetic heart valve, which comprises a bracket main body for supporting a prosthetic valve leaflet and an anchoring frame for anchoring the bracket main body to an annulus; the anchor frame is disposed at a predetermined position near the outflow path side, the holder body is disposed at a predetermined position outside the anchor frame and far from the outflow path side, and the anchor frame abuts against and is connected to the holder body. Compared with a single-layer bracket, the bracket main body and the anchoring frame are respectively used for supporting and anchoring the valve leaflet, and the radial dimension of the bracket main body is smaller, so that the dimension of the artificial valve leaflet is also smaller, and the fatigue resistance of the valve leaflet is improved; the size of the valve leaflet becomes smaller, so the valve leaflet material is correspondingly reduced; the size of the anchoring frame is reduced relative to the inner and outer nested double-layered brackets, so that the anchoring frame is made of less material and skirt material; the less material, the smaller the post-crimping size and the easier to crimp and load.

Description

Artificial heart valve

Technical Field

The invention relates to the technical field of medical appliances, in particular to a heart valve prosthesis for implantation in a heart.

Background

The heart contains four heart chambers, the left atrium and left ventricle being located on the left side of the heart and the right atrium and right ventricle being located on the right side of the heart. The atrium forms a ventricular outflow tract with the ventricle, the left ventricle forms a left ventricular outflow tract with the aorta, and the right ventricle forms a right ventricular outflow tract with the pulmonary artery. Valves with a one-way valve function are arranged at the positions of the chamber inflow channel and the chamber outflow channel, so that the normal flow of blood in the heart chamber is ensured. When this valve becomes problematic, cardiac hemodynamics changes and cardiac dysfunction, known as valvular heart disease.

Mitral regurgitation can lead to myocardial remodeling and progressive ventricular enlargement, ultimately leading to heart failure. Transcatheter mitral valve replacement surgery (TMVR) uses a catheter-mediated approach to compress a prosthetic valve in vitro into a delivery system, deliver the prosthetic valve to the mitral valve annulus of a human, and releasably secure the prosthetic valve to the mitral valve annulus to replace the native valve. Compared with the surgery, TMVR does not need an extracorporeal circulation auxiliary device, has small wound and quick recovery of patients, and can obviously improve the hemodynamic index of the postoperative patients.

Although mitral valve replacement techniques have evolved rapidly, there are still some recognized challenges in the design of valves, such as:

1. The native annulus diameter of the mitral valve is larger than the aortic valve, and accordingly the leaflet area of the prosthetic valve is also larger. The larger the leaflet area, the poorer the fatigue resistance.

2. Aiming at the existing mitral valve prosthesis, the diameter of the conveying catheter is large, so that the conveying difficulty and the risk of vascular injury are increased.

3. The atrioventricular valve assembly has a complex structure, if the height under the prosthetic valve is too high, the native heart structure and the heart function can be influenced, the heart tissue such as papillary muscles are touched abnormally, meanwhile, left ventricular outflow tract obstruction (LVOT) is easily caused, and bad postoperative influence is induced.

Tricuspid valve also suffers from excessive subvalvular height and obstruction of the right ventricular outflow tract.

Disclosure of Invention

The present invention provides a prosthetic heart valve that addresses the above-described deficiencies in the prior art.

The technical scheme of the invention is as follows:

A prosthetic heart valve comprising a stent body for supporting a prosthetic leaflet, and an anchoring frame for anchoring the stent body to an annulus; the anchor frame is disposed at a predetermined position near the outflow path side, the holder body is disposed at a predetermined position outside the anchor frame and away from the outflow path side, and the anchor frame is abutted against and connected with the holder body.

The heart valve is implanted at the annulus to replace the native leaflets for the function of opening and closing the blood passageway. Compared with the existing single-layer bracket, the bracket main body and the anchoring frame are used for supporting the valve leaflet and anchoring respectively, and the radial dimension of the bracket main body is smaller, so that the dimension of the artificial valve leaflet arranged on the bracket main body is also smaller, and the fatigue resistance of the valve leaflet is improved; the size of the valve leaflet becomes smaller, so the valve leaflet material is correspondingly reduced; compared with the traditional double-layer bracket nested inside and outside, the bracket main body and the anchoring frame are of a structure of parallel connection left and right, and the size of the anchoring frame is relatively smaller, so that the materials of the anchoring frame and the skirt materials covered on the anchoring frame are fewer; the less material, the smaller the post-crimping size and the easier to crimp and load.

Studies have shown that if a prosthetic mitral valve is capable of driving blood flow along the side walls of the heart chamber, the blood may turn smoothly, creating a large vortex, directing the blood toward the aorta and then to the whole body. The heart valve with left and right structures, the valve leaves are positioned on the bracket main body, the bracket main body deflects more towards the side of the ventricular wall, and blood flow tends to flow along the ventricular side wall, which is more beneficial to keeping the left atrium natural 'blood flow vortex', thereby promoting the recovery of ventricular function, especially in fragile patients with serious damage to the heart condition. Preferably, the outer peripheral side of the anchoring frame and the outer peripheral side of the bracket main body are abutted against each other and connected at the abutted position. With such a structure, the anchoring frame and the bracket main body can form surface-to-surface contact, so that the connection between the anchoring frame and the bracket main body is more stable.

Preferably, the abutting part of the anchoring frame and the bracket main body is of a single-layer structure, so that the material of the heart valve can be saved.

Preferably, the anchoring frame or the bracket main body is a non-closed structure. The non-closed structure can reduce the material of the anchoring frame or the stent body.

Preferably, the anchoring frame is of an opening structure along the axial direction, the anchoring frame is propped against the periphery of the bracket main body at the opening, and the opening end of the anchoring frame is connected with the bracket main body; or the support main body is of an opening structure along the axial direction, the support main body is propped against the periphery of the anchoring frame at the opening, and the opening end of the support main body is connected with the anchoring frame. The opening structure arranged along the axial direction can further reduce the material of the valve bracket and the skirt material covered on the valve bracket on the premise of not influencing the function of the anchoring frame or the bracket main body, and is easier to hold and release the valve prosthesis.

Preferably, at the abutting position, a part of the anchoring frame is of an open structure, a part of the bracket main body abutting against the anchoring frame is of a non-open structure, other parts of the anchoring frame are of a non-open structure, and a part of the bracket main body abutting against the anchoring frame is of an open structure.

Preferably, the anchoring frame has a notch structure, the notch structure is located at the outflow section of the anchoring frame, and the notch structure is configured to face the direction of the outflow channel. The notch structure prevents the anchoring frame from crossing the ventricular wall, so the prosthetic heart valve does not place the ventricular wall too far against the right side of the aortic valve or the left side of the pulmonary valve. Simultaneously, the notch structure configured at the outflow section reduces the subvalvular height of the frame portion, reducing the risk of outflow tract obstruction.

Preferably, the valve comprises a prosthetic leaflet, and the flap She Bushe is in the main body. The leaflet has one end connected to the body portion and a free end of the leaflet is joined therebetween.

When the valve is in a working state, the artificial valve leaves replace the original valve leaves to realize the function of opening and closing the blood channel.

In order to prevent the heart valve from moving relatively in the conveying system, the heart valve is smoothly implanted in a preset position in the conveying process and is completely detached and released, the heart valve also comprises at least one connecting lug, and the heart valve is connected with the conveying system through the connecting lug; the connecting lugs are arranged at the end part of the inflow section or the end part of the outflow section of the bracket main body, or the connecting lugs are arranged at the end part of the inflow section or the end part of the outflow section of the anchoring frame.

Preferably, the heart valve further comprises a skirt for sealing. The skirt is used for realizing the sealing function, ensures that a single channel of blood flows from the inflow channel end of the heart valve to the outflow channel end of the valve prosthesis, and can effectively prevent paravalvular leakage and regurgitation.

Compared with the prior art, the invention has the following beneficial effects:

First, compared with the structure of the existing single-layer stent, the stent main body and the anchoring frame are respectively used for supporting the valve leaflet and anchoring, and the radial dimension of the stent main body is smaller, so that the dimension of the artificial valve leaflet is smaller, and the fatigue resistance of the valve leaflet is improved; the leaflet size becomes smaller, so the leaflet material is also reduced; compared with the traditional double-layer bracket nested inside and outside, the bracket main body and the anchoring frame adopt a structure of parallel connection left and right, and the size of the anchoring frame is reduced, so that the materials and skirt materials of the anchoring frame are fewer; the less material, the smaller the post-crimping size and the easier to crimp and load. In addition, the heart valve with the left and right structures, the valve leaflets are positioned on the bracket main body, the bracket main body is deviated more towards the ventricular wall side, and blood flow tends to flow along the ventricular side wall, so that the natural 'blood flow vortex' of the left atrium is maintained, and the recovery of ventricular function is promoted, especially in fragile patients with serious damage to the heart condition.

Secondly, the bracket main body and the anchoring frame adopt a structure of parallel connection left and right, so that the bracket main body and the anchoring frame form surface-surface contact, and the connection between the bracket main body and the anchoring frame is more stable.

Thirdly, the anchoring frame is also provided with a notch structure, when the notch structure faces the outflow channel, the notch structure enables the anchoring frame not to cross the wall surface of the ventricle, so that the artificial heart valve can not enable the wall of the ventricle to be too abutted against the right side of the aortic valve or the left side of the pulmonary valve, and the influence of the artificial heart valve body on the heart function can be reduced; when the anchoring frame is in a non-closed structure along the axial direction, the opening structure along the axial direction ensures that the material of the valve bracket and the skirt material covered on the valve bracket can be further reduced on the premise of not influencing the functions of the anchoring frame or the bracket main body, and the valve prosthesis is easier to hold and release.

Of course, it is not necessary for any one product to practice the invention to achieve all of the advantages set forth above at the same time.

Drawings

FIG. 1 is a schematic view showing a part of the structure of a prosthetic heart valve according to embodiment 1 of the present invention;

FIG. 2 is a schematic top view of a prosthetic heart valve of embodiment 1 of the present invention;

FIG. 3 is a schematic perspective view of a prosthetic heart valve of embodiment 1 of the present invention;

fig. 4 is a schematic structural view of an anchor frame of embodiment 1 of the present invention;

FIG. 5 is a schematic top view of an anchor frame of embodiment 1 of the present invention;

FIG. 6 is another schematic perspective view of a prosthetic heart valve of embodiment 1 of the present invention;

FIG. 7 is another schematic structural view of an anchor frame according to embodiment 1 of the present invention;

Fig. 8 is a schematic structural view of a stent body according to embodiment 1 of the present invention;

fig. 9 is a schematic top view of a holder body according to embodiment 1 of the present invention;

Fig. 10 is a schematic structural view of another stent body according to embodiment 1 of the present invention;

Fig. 11 is a schematic top view of still another stand body of embodiment 1 of the present invention;

FIG. 12 is a schematic representation of the implantation of a prosthetic heart valve of example 1 of the present invention in the heart;

FIG. 13 is a schematic view of a prosthetic heart valve of example 3 of the present invention;

FIG. 14 is a schematic view of another prosthetic heart valve of embodiment 3 of the present invention;

FIG. 15 is a schematic view of yet another prosthetic heart valve of example 3 of the present invention;

Fig. 16 is a schematic perspective view of a prosthetic heart valve of embodiment 4 of the present invention.

Reference numerals: a holder main body 110; a body inflow section 111; a body transition section 112; a main body outflow section 113; a hanger 114; an anchor frame 210; an inflow section 211; a transition section 212; an outflow section 213; a securing ear 214; abutment 215; a notch structure 216; a frame open end 300; a body open end 301.

Detailed Description

For purposes of more clarity in describing the structural features of the present invention, the terms "proximal" and "distal" are used as the azimuthal terms, wherein "proximal" refers to the end that is proximal to the apex of the heart during surgery; "distal" means the end distal from the apex of the heart. The terms "heart valve" and "prosthetic heart valve" have the same meaning.

As described herein, when the prosthetic heart valve is a mitral valve, the "outflow tract" refers to the left ventricular outflow tract, and when the prosthetic heart valve is a tricuspid valve, the "outflow tract" refers to the right ventricular outflow tract. As used herein, "quasi-circular" refers to a hexagon and a polygon with more than six sides, which is close to a circle in nature, and "flower-shaped" refers to the shape of the outer edges of petals. As described herein, square includes rectangular and square.

In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are directions or positional relationships based on the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements to be referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

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; can be mechanically or electrically connected; 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 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.

The invention will be further illustrated with reference to specific examples. It should be understood that these examples are illustrative of the present invention and are not intended to limit the scope of the present invention. Modifications and adaptations of the invention will occur to those skilled in the art and are intended to be within the scope of the invention in practice.

Example 1

The present embodiment provides a mitral valve prosthetic heart valve, see fig. 1-12, which is a schematic illustration of the heart valve of the present embodiment, wherein the heart valve comprises a stent body 110 for supporting prosthetic leaflets, and an anchoring frame 210 for anchoring the stent body 110 to the annulus; the anchor frame 210 is disposed at a predetermined position near the left chamber outflow path, and the bracket main body 110 is disposed at a predetermined position outside the anchor frame 210 and far from the left chamber outflow path, with the anchor frame 210 abutting and connected with the bracket main body 110.

At least two artificial leaflets are disposed in the stent body 110, and the number of artificial leaflets may be the same as or different from that of the native leaflets, each leaflet being arranged in the circumferential direction of the stent body 110. The leaflets may be secured to the stent body 110 by direct or indirect connection, with the free ends of the leaflets engaging one another. The material of the valve leaflet is animal pericardium or polymer material, such as pig pericardium and cattle pericardium, and polymer material such as PET or PTFE. The number of artificial valve leaflets and valve leaflet materials can be set according to actual clinical needs, and are not described in detail herein.

In this embodiment, the stent main body 110 and the anchoring frame 210 are connected in parallel, and compared with the existing single-layer stent, the stent main body 110 and the anchoring frame 210 are respectively used for supporting the valve leaflet and anchoring, and the radial dimension of the stent main body 110 is smaller, so that the dimension of the artificial valve leaflet is smaller, and the fatigue resistance of the valve leaflet is improved; the leaflet becomes smaller in size, so the leaflet material decreases. The less anchor frame 210 and skirt material, the less material, the smaller the size after crimping, and the easier crimping and loading than conventional inner and outer nested double-layered brackets.

Studies have shown that if a prosthetic mitral valve is capable of driving blood flow along the side walls of the heart chamber, the blood may turn smoothly, creating a large vortex, directing the blood toward the aorta and then to the whole body. The heart valve with left and right structures, the valve leaves are positioned on the bracket main body, the bracket main body deflects more towards the side of the ventricular wall, and blood flow tends to flow along the ventricular side wall, which is more beneficial to keeping the left atrium natural 'blood flow vortex', thereby promoting the recovery of ventricular function, especially in fragile patients with serious damage to the heart condition. In the present embodiment, the outer peripheral side of the anchor frame 210 and the outer peripheral side of the holder main body 110 abut against each other and are connected at the abutting portion 215. Reference is made to fig. 1,2, 3, 6, wherein fig. 3, 6 are schematic perspective views of a prosthetic heart valve, respectively. The stent body 110 is a cylinder, and the anchoring frame 210 forms an abutment with the stent body 110 from the distal edge to the proximal edge, and is connected at the abutment 215. The stent body 110 and the anchoring frame 210 form a surface-to-surface contact therebetween, so that the connection therebetween is more stable. Of course, in other embodiments, the stent body 110 and the anchor frame 210 may also be connected in abutment at a predetermined position between the two ends. The area and the abutting area between the stent body 110 and the anchoring frame 210 should be selected according to the actual requirements, and the connection site between the stent body 110 and the anchoring frame 210 should not be used to limit the scope of the present invention.

The anchoring frame 210 includes an inflow segment 211, a transition segment 212, and an outflow segment 213, the inflow segment 211 being secured within the left atrium, the transition segment 212 being secured at the annulus, the outflow segment 213 extending into the left ventricle.

With continued reference to fig. 1, 2, 4, 6, and 7, in a preferred embodiment, the outflow section 213 is configured to extend away from the left chamber outflow tract on a side thereof proximate the left chamber outflow tract. When the heart valve is implanted, the outflow segment 213 of the anchoring frame 210 is gradually moved away from the left ventricular outflow tract, so that the heart valve of the present embodiment can reduce the effect on heart function and prevent conduction block.

In this embodiment, on the side close to the left chamber outflow channel, the distance between the outflow section 213 and the axial center of the stand body 110 is R, wherein R gradually decreases in a linear manner from the distal end to the proximal end, as shown in fig. 6, and the outflow section 213 is a slope. Of course, in other embodiments, R may alternatively be tapered in a non-linear fashion, such as an arcuate surface, again enabling a reduced risk of left-hand outflow tract obstruction.

With continued reference to fig. 7, the tangential to the outflow section 213 is at an angle α to the axial direction, and α is an acute angle, near the outflow channel side of the left chamber. If the angle α is too small, the outflow section 213 deviates from the outflow tract to a too small extent, increasing the risk of blockage of the outflow tract, and if the angle α is too large, increasing the resistance to crimping, the angle α is preferably in the range of 30 ° to 60 °.

Referring to fig. 8, the stent body 110 in the present embodiment is a cylinder, and includes a body inflow section 111, a body transition section 112, and a body outflow section 113. Of course, in other embodiments, the bracket main body 110 may be an elliptical cylinder (as shown in fig. 10), a cone, or a combination of a cylinder and a cone. In this embodiment, the cross section of the bracket main body 110 is a circle (as shown in fig. 9), and in other embodiments, the cross section of the bracket main body 110 may be configured like a circle, a D-shape, or a flower shape, or a combination structure. As shown in fig. 11, the bracket main body 110 has a flower-shaped cross section.

The bracket main body 110 is a net structure composed of a plurality of rows of units, the constituent units of the embodiment are diamond structures, and the diamond net surface has the advantages of simple forming process and smoother net surface. In other alternative embodiments, the constituent cells may also be triangular, square, pentagonal, drop-shaped, etc. grid cells that may form a closed shape. The stent body 110 is used for fixing the valve leaflet, so that the specific shape and the shape of the constituent unit can be selected according to the actual requirements, and are not intended to limit the scope of the present invention.

With continued reference to fig. 8 and 10, the proximal end of the main body outflow section 113 of the stent main body 110 is further provided with a tab 114, the tab 114 being adapted to be connected to a delivery system, ensuring that the heart valve is loaded into the delivery system, released from the delivery system and the relative position of the valve to the delivery system during delivery is unchanged. Of course, in other embodiments, the lugs 114 may also be provided at the distal end of the body inflow section 111, or at both ends of the stent body 110.

Since the heart valve is implanted in the body via a delivery system, the stent body 110 should have some ability to elastically deform and be crimped within the delivery system during delivery. The bracket main body 110 of the embodiment is manufactured by cutting nickel-titanium alloy pipes, the outer diameter of the pipes is 5-15 mm, and the diameter size after shaping is selected according to actual needs. In other embodiments, the material of the stent body 110 also includes an elastically or plastically deformable material, such as a balloon expandable, or may be a shape memory alloy that is responsive to a temperature change to transition between a contracted delivery state and an expanded deployment state. Specifically, the stent body 110 may be made of, for example, nitinol, titanium alloy, cobalt chrome alloy, MP35n, 316 stainless steel, L605, phynox/Elgiloy, platinum chrome, or other biocompatible metals as known to those skilled in the art.

With continued reference to fig. 4, as a schematic structural view of the anchor frame 210 of the present embodiment, the outer circumferential side of the anchor frame 210 may be preconfigured to the same curvature as the outer circumferential side of the stent body 110, i.e., configured to be partially recessed at the center in the circumferential direction, and then fixed to the outer circumference of the stent body 1.

In an alternative embodiment, the anchoring frame 210 is a column, the anchoring frame 210 is connected to the outer circumferential side of the bracket body 110, and the bracket body 110 and the anchoring frame 210 form a structure that abuts against each other after the connection is completed. The anchoring frame 210 may be configured as a cylinder, an elliptical cylinder, a cone, or a combination of a cylinder and a cone. The cross-sectional shape of the anchor frame 210 may be circular, D-shaped, quasi-circular, flower-shaped, or other irregular shape, or a combination of these shapes.

The anchor frame 210 is a mesh structure composed of a plurality of rows of cells, which in this embodiment are diamond-shaped cells. Of course, in other embodiments, the cells may also be triangular, square, pentagonal, round-like, drop-shaped, etc. grid cells that may form a closed shape. The shape, number, and arrangement of the anchor frames 210 should be selected according to actual needs, and are not limited herein.

In another alternative embodiment, the proximal end of the outflow section 213 of the anchoring frame 210 is further provided with securing ears 214, the securing ears 214 being adapted to be connected to a delivery system to ensure that the heart valve is loaded into the delivery system, released from the delivery system and the relative position of the valve to the delivery system during delivery is unchanged. Of course, in other embodiments, the securing ears 214 may also be provided at the distal end of the inflow segment 211, or at both ends of the anchor frame 210.

Since the heart valve is crimped into the delivery system for delivery, the anchoring frame 210 should have a stiffness that is less than the stiffness of the stent body 110. Preferably, the anchoring frame 210 of the present embodiment is woven from nickel-titanium alloy, and the weaving process provides the anchoring frame 210 with better deformability and is easy to hold and transport. Of course, in other embodiments, the anchor frame 210 may also employ an elastically or plastically deformable material, such as balloon-expandable, or may be a shape memory alloy that is responsive to a temperature change to transition between a contracted delivery state and an expanded deployment state. Such as with nitinol, titanium alloy, cobalt chrome alloy, MP35n, 316 stainless steel, L605, phynox/Elgiloy, platinum chrome, or other biocompatible metals as known to those skilled in the art.

In this embodiment, the connection is performed at the contact points of the bracket main body 110 and the anchoring frame 210, specifically, the connection may be performed by riveting, welding, fastening, or sewing, and an appropriate connection manner may be selected according to the materials of the bracket main body 110 and the anchoring frame 210.

Further, the heart valve of the present embodiment also includes a skirt for sealing. The skirt may be disposed on the inner surface, the outer surface, or both the inner and outer surfaces of the stent body 110, or the inner surface, the outer surface, or both the inner and outer surfaces of the anchoring frame 210. The skirt is used for realizing the sealing function, ensures that a single channel of blood flows from the inflow channel end of the heart valve to the outflow channel end of the valve prosthesis, and can effectively prevent paravalvular leakage and regurgitation. Wherein the skirt is made of animal pericardium or biocompatible polymer material, such as pig pericardium and cattle pericardium, and biocompatible polymer material such as PET and PTFE. The area, area and material of the skirt should be set according to the actual clinical requirements, and are not limited here.

In this embodiment, the anchoring form of the valve prosthesis is not limited, and flanges may be provided on the stent main body 110 and the anchoring frame 210, and the anchoring form of Oversize may be adopted; anchoring structures such as thorns, flukes and the like can be arranged on the bracket main body 110 and the anchoring frame 210 to grasp the primary tissues, and the anchoring structures can also be fixed in a mode of anchoring the tether to the ventricular wall or in a mode of combining a plurality of modes.

Example 2

The present embodiment provides a tricuspid valve prosthesis, which has a structure similar to that of embodiment 1, except that the stent body 110 of the present embodiment is implanted at an annulus in the right ventricular outflow tract, and the anchoring frame 210 is fixed at a predetermined position near the right ventricular outflow tract.

In order to reduce the impact of the heart valve on the right chamber outflow tract, the outflow segment 213 is arranged gradually further away from the right chamber outflow tract, thereby reducing the risk of obstruction of the right chamber outflow tract.

Example 3

The present embodiment provides a prosthetic heart valve, which is an improvement on the basis of embodiment 1 or embodiment 2, wherein the abutment 215 of the anchoring frame 210 and the stent body 110 is of a single-layer structure.

In one embodiment, referring to fig. 13, a schematic view of the prosthetic heart valve of the present embodiment is shown, wherein the anchoring frame 210 is a non-closed structure. That is, the anchoring frame 210 has an open structure in the axial direction, the cross section of which is C-shaped, the open end of the anchoring frame 210 in the axial direction is a frame open end 300, and the frame open end 300 is abutted to the outer circumference of the bracket main body 110 and connected.

In another embodiment, referring to fig. 14, a schematic view of the prosthetic heart valve of the present embodiment is shown, wherein the stent body 110 is a non-closed structure, the stent body 110 is an open structure along the axial direction, the cross section of the open structure is C-shaped, the open end of the stent body 110 is a body open end 301, and the body open end 301 abuts against the periphery of the anchoring frame 210 and is connected.

In another alternative embodiment, at the abutment 215, a portion of the anchor frame 210 is in a non-closed configuration, while a portion of the stent body 110 abutting thereto is in a closed configuration, and the other portion of the anchor frame 210 is in a closed configuration, while a portion of the stent body 110 abutting thereto is in a non-closed configuration. Referring to fig. 15, for a schematic perspective view of the heart valve of the present embodiment, the anchoring frame 210 is opened at a predetermined position at the proximal end and the stent body 110 is opened at a predetermined position at the distal end, wherein the frame opening end 300 abuts against the outer periphery of the stent body 110 and the body opening end 301 abuts against the outer periphery of the anchoring frame 210, so that the abutting portion 215 is of a single-layer structure.

The axially disposed open structure allows for a further reduction in the material of the valve stent, as well as the skirt material overlying it, without affecting the function of the anchoring frame 210 or stent body 110, making crimping and release of the valve prosthesis easier.

Example 4

This embodiment provides a prosthetic heart valve that is an improvement over embodiments 1,2 or 3, wherein the outflow section of the anchoring frame 210 is configured with a notch arrangement 216, see fig. 16. The notch structure 216 is disposed toward the outflow tract side.

The notch structure 216 prevents the anchoring frame from crossing the ventricular wall surface, so that the prosthetic heart valve does not place the ventricular wall too far against the right side of the aortic valve or the left side of the pulmonary valve, and the impact of the prosthetic heart valve body on heart function can be reduced.

The notch arrangement 216 reduces the subvalvular height of the outflow section 213, thereby reducing the risk of outflow tract obstruction. The shape and area of the notch structure 216 should be configured according to clinical needs, and are not intended to limit the scope of the present invention.

The foregoing disclosure is only of the preferred embodiments of the invention. The preferred embodiments are not exhaustive or to limit the invention to the precise form disclosed. Obviously, many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and the practical application, to thereby enable others skilled in the art to best utilize the invention. The invention is limited only by the claims and the full scope and equivalents thereof.

Claims

1. A prosthetic heart valve comprising a stent body for supporting a prosthetic leaflet and an anchoring frame for anchoring the stent body to an annulus; the anchoring frame is arranged at a preset position close to the outflow channel side, the bracket main body is arranged outside the anchoring frame and is far away from the preset position of the outflow channel side, and the anchoring frame is abutted against and connected with the bracket main body; wherein the outer peripheral side of the anchoring frame and the outer peripheral side of the bracket main body are mutually abutted and connected at an abutting position; the anchoring frame comprises an inflow section, a transition section and an outflow section, wherein the inflow section is fixed in the left atrium, the transition section is fixed at the annulus, and the outflow section extends into the left atrium; the anchoring frame has a notch structure located at the outflow section of the anchoring frame, and the notch structure is configured to face the direction of the outflow channel.

2. The prosthetic heart valve of claim 1, wherein the anchor frame is of single-layer construction against the stent body.

3. The prosthetic heart valve of claim 2, wherein the anchoring frame or the stent body is a non-closed structure.

4. The prosthetic heart valve of claim 3, wherein the anchoring frame is an open structure in an axial direction, the open end of the anchoring frame being connected to the stent body; or the support main body is of an opening structure along the axial direction, and the opening end of the support main body is connected with the anchoring frame.

5. The prosthetic heart valve of claim 2, wherein at the abutment, a portion of the anchoring frame is open, a portion of the stent body against which it abuts is non-open, while other portions of the anchoring frame are non-open, and a portion of the stent body against which it abuts is open.

6. The prosthetic heart valve of claim 1, further comprising at least one connector lug by which the heart valve is connected to a delivery system; the connecting lugs are arranged on the bracket main body or the anchoring frame.

7. The heart valve prosthesis of claim 1, wherein the valve comprises a prosthetic leaflet, the leaflet She Bushe in the body portion.

8. The prosthetic heart valve of claim 1, wherein the anchoring frame or the stent body is further provided with a skirt for sealing.