CN111772878A

CN111772878A - Heart valve prosthesis

Info

Publication number: CN111772878A
Application number: CN202010680119.3A
Authority: CN
Inventors: 不公告发明人
Original assignee: Shanghai Zhenyi Medical Technology Co ltd
Current assignee: Jiangsu Zhenyi Medical Technology Co.,Ltd.; Shanghai Zhenyi Medical Technology Co.,Ltd.
Priority date: 2020-07-15
Filing date: 2020-07-15
Publication date: 2020-10-16

Abstract

The invention discloses a heart valve prosthesis, which comprises a support and a valve, wherein the support comprises a main body part for supporting the valve and a frame part for fixing the main body part. The main body part and the valve are fixed at the valve ring through the frame part to replace a native valve, so that the function of opening and closing a blood channel is realized, the first ventricle section of the frame part is far away from the outflow channel at the outflow channel, and the longitudinal size of the frame part against the atrium and the valve ring is small, so that the influence of the valve prosthesis on the heart function can be reduced, and the conduction block can be prevented; the valve leaflet is positioned in the main body part of the support, and the radial size of the main body part is smaller, so that the size of the artificial valve leaflet is smaller, and the fatigue resistance of the valve leaflet is improved; meanwhile, as the whole size of the valve prosthesis is reduced, the pressing and holding space of the outflow tract is saved, the size of a required conveying system is reduced, and the valve prosthesis is easy to load and convey.

Description

Heart valve prosthesis

Technical Field

The invention relates to the technical field of medical instruments, in particular to a heart valve prosthesis implanted in a heart.

Background

The heart contains four 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. A ventricular inflow channel is formed between the atrium and the ventricle, a left ventricular outflow channel is formed between the left ventricle and the aorta, and a right ventricular outflow channel is formed between the right ventricle and the pulmonary artery. Valves with the function of a one-way valve are arranged at the left ventricle inflow channel and the left ventricle outflow channel, so that the normal flow of blood in the heart cavity is ensured. When a problem occurs with the valve, the hemodynamics of the heart change and the heart functions abnormally, which is called valvular heart disease.

Mitral regurgitation can lead to myocardial remodeling, progressive enlargement of the ventricles, and ultimately heart failure. Transcatheter mitral valve replacement surgery (TMVR) employs a catheter-based approach to extracorporeally compress a prosthetic valve to a delivery system for delivery to the mitral annulus of a human subject, and release-secure the prosthetic valve at the mitral annulus to replace the native valve. Compared with the surgical operation, the TMVR does not need an extracorporeal circulation auxiliary device, has small wound and quick recovery of the patient, and can obviously improve the hemodynamics index of the postoperative patient.

Although mitral valve replacement techniques have been developed at a rapid pace, there are several recognized challenges in the design of valves, such as:

1. the atrioventricular valve assembly has a complex structure, and if the height below the prosthetic valve is too high, the native cardiac structure and cardiac function are affected, and the heart tissue such as papillary muscles is touched to cause abnormal conditions, and meanwhile, left ventricular outflow tract obstruction (LVOT) is easily caused, and adverse postoperative influence is induced.

2. The native annulus of the mitral valve is larger in diameter compared to the aortic valve, and accordingly, the leaflet area of the prosthetic valve is also large.

The tricuspid valve also has the problem of outflow tract blockage, most of the existing valve stents have single-layer structures, the area of the valve leaflet corresponding to the stent with the single-layer structure is large, and the larger the area of the valve leaflet is, the worse the fatigue resistance is. Meanwhile, the valve leaflet has a large area, the size of the needed stent is correspondingly large, the diameter of a catheter for conveying the valve prosthesis is also large, and the conveying difficulty and the risk of blood vessel injury are increased.

Disclosure of Invention

The present invention provides a heart valve prosthesis which can solve the above-mentioned defects in the prior art.

The technical scheme of the invention is as follows:

a heart valve prosthesis comprising a valve, a stent;

the stent comprises a body portion for supporting a valve and a frame portion for securing the body portion at a native annulus, the body portion being connected with the frame portion;

the frame portion includes an atrial segment deployed within an atrium, a valve ring segment deployed at an annulus, and a ventricular segment deployed within a ventricle; the ventricular segment comprises a first ventricular segment located on a side proximal to the outflow tract; the first ventricular segment is spaced from the axis of the frame portion by a distance R1, wherein R1 tapers in a linear or non-linear manner in the atrial-to-ventricular direction. The first ventricular segment is gradually far away from the outflow tract, and the longitudinal size of the frame part abutting against the atrium and the valve ring is small so as to reduce the influence of the valve prosthesis on the heart function and prevent conduction block.

Because the valve is positioned in the main body part of the stent, compared with the existing single-layer stent, the radial size of the main body part is smaller, the size of the artificial valve leaflet is smaller, and the fatigue resistance of the valve leaflet is improved; and, because the radial dimension of main part is less, valve prosthesis bulk size diminishes, easily loads and transports.

Preferably, an included angle between a tangent of the first ventricular segment and the axial direction is alpha, and alpha is an acute angle; preferably, the included angle α is in the range of 30 ° to 60 °. If the angle α is too small, the first ventricular segment 2131 will deviate from the outflow tract too little, increasing the risk of obstruction of the outflow tract, and if too large, increasing the resistance to squeezing, therefore the angle α is preferably in the range of 30 ° to 60 °.

Preferably, the main body and the frame are nested inside and outside, the main body is nested inside, and a distance between an axis of the main body and an axis of the frame is r, where r is greater than 0. The main body part and the frame part are fixed in an eccentric mode, and the main body part is far away from one side of the outflow channel, so that the risk of blockage of the outflow channel is further reduced. Research shows that if the artificial mitral valve can drive blood to flow along the side wall of the ventricle, the blood can turn smoothly and generate a large vortex, so that the blood is shot to the aorta and then flows to the whole body. Heart valves of eccentric construction, because the leaflets are on the stent body, which is biased toward the ventricular wall, blood flow tends to follow the ventricular sidewall, which is more beneficial in maintaining the natural "swirl of blood flow" in the left atrium, thereby promoting recovery of ventricular function, especially in vulnerable patients with severely compromised heart conditions.

Preferably, the main body part is far away from the outflow channel and abuts against the frame part, the abutting of the main body part and the frame part can generate more connecting points, the main body part and the frame part are convenient to fixedly connect, the main body part is far away from one side of the outflow channel to the maximum extent, and the risk of blockage of the outflow channel is reduced.

Preferably, the frame portion and the main body portion are arranged in a left-right parallel configuration, wherein the frame portion is located on a side close to the outlet, the main body portion is located outside the frame portion, and the frame portion abuts against an outer peripheral side of the main body portion and is connected at the abutting portion.

Preferably, the frame part is a non-closed structure, the non-closed structure can reduce the material of the support, and the non-closed structure enables the valve prosthesis to be easily crimped.

In a preferred embodiment, the frame part is of an opening structure along the axial direction, the frame part is connected with the outer periphery of the main body part at the opening, and the non-closed structure can reduce the material of the bracket, so that the valve prosthesis is easier to press and transport due to the reduction of the material.

Preferably, the bracket further comprises a fixing part fixed to the conveying system, and the fixing part is disposed at an end of the main body part or an end of the frame part. The fixing part is connected with the delivery system for loading and releasing the valve prosthesis to separate from the delivery system, and the valve prosthesis is ensured not to be displaced when being transported in the delivery system.

Preferably, the valve comprises a prosthetic valve leaflet which is arranged on the main body part. The leaflets are connected at one end to the body portion with a commissure between the free ends of the leaflets.

Under the working state of the valve, the artificial valve leaf replaces the native valve leaf to realize the function of opening and closing the blood channel.

Preferably, the bracket is further provided with a skirt for sealing. The shirt rim is used for realizing sealed function, guarantees that the single passageway of blood can effectively prevent perivalvular leakage and palirrhea for flowing into the outflow way end that says that the end flows to valve prosthesis from valve prosthesis.

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

firstly, the main body part and the valve are fixed at the native valve ring of the inflow channel through the frame part to replace the native valve, so that the function of opening and closing a blood channel is realized, the first ventricle section of the frame part is far away from the outflow channel at the position close to the outflow channel, the longitudinal size of the frame part against the atrium and the valve ring is small, the main body part is also far away from the outflow channel to the maximum extent, the influence of the valve prosthesis on the heart function can be reduced, and the conduction block can be prevented.

Secondly, the valve leaflet is positioned in the main body part of the stent, and compared with the existing single-layer stent, the radial size of the main body part is smaller, so that the size of the artificial valve leaflet is smaller, and the fatigue resistance of the valve leaflet is improved; meanwhile, as the radial size of the main body part is smaller, the whole size of the valve prosthesis is reduced, the pressing and holding space of the outflow tract is saved, the size of a required conveying system is reduced, and the valve prosthesis is easy to load and convey.

Third, when the main body portion and the frame portion are arranged at a predetermined distance from each other, i.e., in an eccentric configuration, or when the main body portion and the frame portion are arranged in a left-right connection configuration, when the stent is used as a mitral valve, because the stent main body is biased toward the ventricular wall, blood tends to flow along the ventricular sidewall, which is more beneficial to maintain the natural "blood flow vortex" of the left atrium, thereby promoting the recovery of ventricular function, especially in a vulnerable patient with severely damaged heart conditions.

Fourthly, when the main body part and the frame part are connected in a left-right mode, the material of the bracket can be reduced; when the frame part is in a non-closed structure, the material of the bracket can be further reduced, and the clamping, loading and transportation of the valve prosthesis are easier due to the reduced material.

Of course, it is not necessary for any product in which the invention is practiced to achieve all of the above-described advantages at the same time.

Drawings

FIG. 1 is a schematic view of the overall structure of a stent according to example 1 of the present invention;

fig. 2 is a schematic structural view of a frame portion of embodiment 1 of the present invention;

FIG. 3 is a schematic structural view of the valve prosthesis of example 1 of the present invention delivered into the heart;

FIG. 4 is a schematic perspective view of a stent of embodiment 1 of the present invention;

FIG. 5 is a schematic structural view of a main body part in embodiment 1 of the present invention;

FIG. 6 is a schematic plan view of a main body part in embodiment 1 of the present invention;

FIG. 7 is a schematic top view of a stent according to example 1 of the present invention;

FIG. 8 is another schematic top view of the stent of example 1 of the present invention;

FIG. 9 is a schematic view of a stent and anchoring structure according to example 1 of the present invention;

FIG. 10 is a schematic top view of a stent and anchoring structure according to example 1 of the present invention;

FIG. 11 is a schematic structural view of a stent according to example 2 of the present invention;

FIG. 12 is a schematic structural view of a stent according to example 2 of the present invention;

fig. 13 is a top view of a frame portion of embodiment 3 of the invention;

fig. 14 is a schematic structural view of a stent of embodiment 3 of the present invention.

Reference numerals: a bracket 100; a main body portion 110; a frame portion 210; an atrial segment 211; a flap ring segment 212; ventricular segment 213, first ventricular segment 2131; a second ventricular segment 2132; an inflow section 111; an outflow section 113; a transition section 112; a hanging lug 114; securing ears 214.

Detailed Description

The invention provides a heart valve prosthesis, comprising a valve and a bracket for fixing the valve at a native valve ring; the support comprises a main body part for supporting the valve and a frame part for fixing the main body part, wherein the main body part is connected with the frame part, the longitudinal dimension of the frame part abutting against the atrium and the valve ring on the side close to the outflow tract is small, and when the first ventricle section extends towards the main body part, the influence of the valve prosthesis on the heart function can be reduced, and the conduction block can be prevented.

The heart valve prosthesis of the invention is applicable to mitral valves as well as tricuspid valves, and as described herein, when the valve prosthesis is a mitral valve, it is fixed at the native annulus of the left ventricular inflow tract, where the term "outflow tract" refers to the left ventricular outflow tract. When the valve prosthesis is a tricuspid valve, it is fixed at the native annulus of the right ventricular inflow tract, in which case the term "outflow tract" refers to the right ventricular outflow tract.

The invention is further illustrated below by way of a mitral valve as an example.

To more clearly describe the structural features of the present invention, the terms "proximal" and "distal" are used as terms of orientation, wherein "proximal" refers to the end that is near the apex of the heart during a procedure; "distal" means the end distal to the apex of the heart.

As used herein, "longitudinal height" refers to the dimension of a component in the axial direction of the valve prosthesis. As used herein, "valve prosthesis" has the same meaning as "heart valve prosthesis". As used herein, the term "valve" when used alone refers to a plurality of prosthetic leaflets secured about the circumference of a main body portion. As used herein, the "left ventricular outflow tract" has the same meaning as LVOT.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular 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 otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically 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 specific cases to those skilled in the art.

As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

The implant of the present invention will be described in further detail with reference to the accompanying drawings and specific embodiments. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is provided solely for the purpose of facilitating and distinctly claiming the embodiments of the present invention. It should be understood that these examples are only for illustrating the present invention and are not intended to limit the scope of the present invention. In practice, the invention will be understood to cover all modifications and variations of this invention provided they come within the scope of the appended claims.

Example 1

The present embodiment provides a mitral heart valve prosthesis, which is a schematic view of the valve prosthesis of the present embodiment, and includes a valve and a stent 100, see fig. 1 to 10.

The stent 100 comprises a main body part 110 for supporting the valve and a frame part 210 for fixing the main body part 110, wherein the main body part 110 is connected with the frame part 210; frame portion 210 includes an atrial section 211 deployed within the atrium, an annulus section 212 deployed at the annulus, and a ventricular section 213 deployed within the ventricle, the annulus section 212 being located between the atrial section 211 and the ventricular section 213. The ventricular segment 213 includes a first ventricular segment 2131 and a second ventricular segment 2132, the first ventricular segment 2131 being located on a side proximal to the left ventricular outflow tract, and the second ventricular segment 2132 being located on a side distal to the left ventricular outflow tract.

On the side near the left ventricular outflow tract, the atrial segment 211 and the annulus segment 212 abut the atrium and the annulus, respectively, at a corresponding height L1, as shown in fig. 2 and 4. On the side remote from the left chamber outflow tract, frame portion 210 has a height L2, wherein L1 is less than L2; and the first ventricular segment 2131 is configured to extend away from the left ventricular outflow tract to reduce the effect of the valvular prosthesis on cardiac function and prevent conduction block.

Referring to fig. 3, the body portion 110, the valve, is secured at the annulus of the left ventricular inflow tract by a frame portion 210, replacing the native valve. On the left ventricular outflow tract side, the longitudinal dimension of the frame portion 210 against the atrium and annulus is small, and the first ventricular segment 2131 of the frame portion 210 is far away from the left ventricular outflow tract, so that the influence of the valve prosthesis on the heart function can be reduced, and the conduction block can be prevented. Meanwhile, the valve leaflet of the embodiment is positioned in the main body part of the support, and compared with a single-layer support, the radial size of the main body part is smaller, so that the size of the artificial valve leaflet is smaller, and the fatigue resistance of the valve leaflet is improved. And, because the radial dimension of main part is less, valve prosthesis bulk size diminishes, easily loads and transports.

Referring to fig. 2 and 4, the first ventricular segment 2131 is spaced from the axis B-B of the frame portion 210 by a distance R1 and the second ventricular segment 2132 is spaced from the axis B-B of the frame portion 210 by a distance R2. In one embodiment, R1 tapers in a linear manner from the atrium to the ventricle while R2 remains unchanged when the first ventricular segment 2131 is a sloped surface. Of course, in other embodiments, R1 may also taper in a non-linear manner, such that the first ventricular segment 2131 is arcuate in shape, again to achieve a reduced risk of left ventricular outflow tract occlusion. When the first ventricular segment 2131 is an arc, R1 refers to the distance from the tangent to the axis of the arc at a predetermined point.

The tangent to the first ventricular segment 2131 includes an acute angle α with the axial direction. If the angle α is too small, the first ventricular segment 2131 will deviate from the outflow tract too little, increasing the risk of obstruction of the outflow tract, and if too large, increasing the resistance to squeezing, therefore the angle α is preferably in the range of 30 ° to 60 °.

In this embodiment, the main body 110 and the frame 210 are nested inside and outside, the main body 110 is nested inside, the frame 210 is nested outside, and a distance between an axis a-a of the main body 110 and an axis B-B of the frame 210 is r, where r is greater than 0, as shown in fig. 4. That is, the main body 110 and the frame 210 are eccentrically designed, and the main body 110 is offset in a direction away from the left ventricular outflow tract, so that the risk of blockage of the left ventricular outflow tract can be further reduced.

The magnitude of r determines the degree of eccentricity of the body 110, and the smaller r, the smaller the degree of deviation, and the larger r, the larger the degree of eccentricity of the body 110. Preferably, in the present embodiment, the main body portion 110 is far away from the left chamber outflow tract and abuts against the frame portion 210, as shown in fig. 1, 3, 4 and 9. At this time, r is at the maximum, and the outer peripheral side of the body 110 abuts against the frame portion 210. The outer circumference of the main body 110 abuts against the frame 210 to form more connection points, which facilitates the fixed connection between the main body and the frame, and the main body is furthest away from the side of the outflow channel, thereby reducing the risk of blockage of the outflow channel.

Meanwhile, research shows that if the artificial mitral valve can drive blood to flow along the side wall of the ventricle, the blood can turn smoothly and generate a large vortex, so that the blood is emitted to the aorta and then flows to the whole body. Heart valves of eccentric construction, because the leaflets are on the stent body, which is biased toward the ventricular wall, blood flow tends to follow the ventricular sidewall, which is more beneficial in maintaining the natural "swirl of blood flow" in the left atrium, thereby promoting recovery of ventricular function, especially in vulnerable patients with severely compromised heart conditions.

In this embodiment, the connection between the frame portion 210 and the main body portion 110 may be formed by riveting, welding, snapping, stitching, or bonding with an adhesive, so as to ensure that the main body portion 110 and the frame portion 210 do not move relative to each other, and the specific connection manner may be selected according to the materials, the molding manners, and the like of the frame portion 210 and the main body portion 110, and is not limited herein.

As shown in fig. 5, it is a schematic structural diagram of the main body 110 of the present embodiment. The body portion 110 includes an inflow section 111, an outflow section 113, and a transition section 112 therebetween. The main body 110 is an elliptical cylinder. Of course, in other embodiments, the body 110 may be a cylinder, as shown in fig. 7, or a cone, or a combination of a cylinder and a cone. The cross-sectional shape of the body portion 110 may be circular, or may be quasi-circular, D-shaped, flower-shaped, or other irregular shapes. The quasi-circular shape refers to a hexagon and a polygon with more than six sides, the nature of the polygon is close to a circle, and the flower shape is shown in fig. 6.

The main body 110 is configured to have a mesh structure with a plurality of rows of constituent units, in this embodiment, the constituent units are diamond-shaped structures, which has the advantage of simple forming process, and the formed diamond-shaped mesh surface is more flat. Of course, in other embodiments, the constituent units may also be triangular, square, pentagonal, quasi-circular, drop-shaped, etc. grid units that can form a closed shape, and a square includes a rectangle and a square. The shape and size of the constituent elements and the number of rows of the constituent elements are selected according to the material, process, etc. of the main body.

The body portion 110 may be selected from a self-expanding or plastically deformable material, such as a balloon expandable, or may be a shape memory alloy that is responsive to temperature changes to transition between a contracted delivery state and an expanded deployed state. In particular, the body portion 110 may be made of, for example, nitinol, titanium alloy, cobalt-chromium alloy, MP35n, 316 stainless steel, L605, Phynox/Elgiloy, platinum-chromium, or other biocompatible metals as known to those skilled in the art. Preferably, the main body portion 110 of this embodiment is made of a nickel-titanium alloy tube by cutting, and the process is more mature and reliable, wherein the outer diameter of the tube is 5-15 mm, and the outer diameter of the tube is the size in a natural state, and the diameter size after shaping should be selected according to actual needs.

With continued reference to FIG. 2, frame portion 210 is a cylindrical composite structure in which atrial section 211 has a large radial dimension, ventricular section 213 is an asymmetric structure, and frame portion 210 is circular in cross-section, D-shaped. Of course, in other embodiments, the frame portion 210 may also be a cone, or a combination of a cylinder and a cone, and the cross-sectional shape of the frame portion 210 may also be a quasi-circular shape, a D-shape, a flower shape, or other irregular shape, or a combination of a plurality thereof.

The frame portion 210 is configured to have a mesh structure with several rows of constituent units, in this embodiment, the constituent units are diamond-shaped structures, but in other embodiments, the constituent units may also be triangular, diamond-shaped, pentagonal, quasi-circular, drop-shaped, and the like, which may form a closed shape. The shape and size of the constituent elements and the number of rows of the constituent elements are selected according to the material, process, etc. of the main body.

The frame portion 210 may be made of, for example, nitinol, titanium alloy, cobalt chromium alloy, MP35n, 316 stainless steel, L605, Phynox/Elgiloy, platinum chromium, or other biocompatible metals as known to those skilled in the art. Optionally, an elastically or plastically deformable material is also included, such as a balloon expandable, or may be a shape memory alloy that is responsive to temperature changes to transition between a contracted delivery state and an expanded deployed state. Preferably, the frame portion 210 of the present embodiment is woven from nitinol, and in alternative embodiments, the frame portion 210 may be made from a relatively low stiffness material. This may further reduce the influence of the valve prosthesis on the heart function.

Further, the stent 100 may further comprise a fixation portion that is secured to the delivery system, the fixation portion being connected to the delivery system, such as to a delivery sheath, to ensure that the valve prosthesis is loaded into the delivery system, released from the delivery system, and transported in vivo without changing the relative position of the valve prosthesis and the delivery system. Referring to fig. 5, in this embodiment, the securing portion is a tab 114 disposed at the proximal end of the outflow section 113, the tab 114 being adapted to couple to a delivery system. Of course, in other embodiments, the fixation portion may also be disposed at the distal end of the inflow section 111, or at both the proximal end of the outflow section 113 and the distal end of the inflow section 111.

In another alternative embodiment, the fixation portion further comprises fixation ears 214 disposed at the proximal end of the ventricular segment 213, as shown in FIG. 2. Of course, in other alternative embodiments, the fixation portion may also be disposed distal to the atrial segment 211, or both proximal to the ventricular segment 213 and distal to the atrial segment 211. The fixing part is connected with the delivery system, therefore, the position and the number of the fixing part configuration are selected according to the type and the implantation mode of the delivery system, and are not limited here.

The valve prosthesis of this embodiment is a mitral valve prosthesis, and the valve has at least two leaflets, one end of which is connected directly or indirectly to the main body 110, and the free ends of which are joined together. In the working state, the artificial valve leaf replaces the native valve leaf to realize the function of opening and closing the blood channel. The valve leaflet can be made of animal pericardium or other biocompatible polymer materials, such as PET or PTFE. The selection of the size and the material can be carried out according to different application scenes.

In this embodiment, the holder 100 is further provided with a skirt for sealing. The shirt rim is used for realizing sealed function, guarantees that the single passageway of blood can effectively prevent perivalvular leakage and palirrhea for flowing into the outflow way end that says that the end flows to valve prosthesis from valve prosthesis. The skirt may be disposed only on the main body 110, only on the frame 210, or both the main body 110 and the frame 210; the skirt can be laid on a single surface or double surfaces. When the skirt is disposed over the annular region formed by the body portion 110 and the frame portion 210, the skirt serves to prevent thrombus from forming in the annular region.

The skirt is made of animal pericardium or biocompatible polymer material, the animal pericardium is pig pericardium or bovine pericardium, and the biocompatible polymer material is PET or PTFE. The area of skirt deployment, the deployment area and the materials should be set according to the actual clinical requirements and are not limited here.

The anchoring form of the valve prosthesis is not limited in this embodiment, and a flange may be provided on the stent 100, as shown in fig. 7 and 8, and the anchoring form of Oversize is adopted; the stent 100 may also be provided with anchoring structures such as spines, flukes and the like to grasp native tissues, as shown in fig. 1 and 3; the fixation may also be by tether anchoring to the myocardial wall, or may be by a combination of means. As shown in fig. 9 and 10, the valve prosthesis is fixed by a combination of a flange and a tether, the atrial section 211 of the frame portion 210 is provided with a flange, and the outflow section 113 of the main body portion 110 is connected with a tether, which is anchored to the myocardial wall. The specific anchoring form should be selected according to the actual diagnosis and treatment requirements.

Example 2

The present embodiment provides a valve prosthesis, which is an improvement over embodiment 1, wherein the frame portion 210 and the main body portion 110 are configured to be juxtaposed in the left-right direction.

Referring to fig. 11, which is a schematic view of the overall structure of the stand 100 of the present embodiment, fig. 12 is a schematic perspective view of the stand 100. The main body 110 is a cylinder, the main body 110 is located outside the frame 210, and the outer periphery of the frame 210 abuts against the outer periphery of the main body 110 and is connected to the abutting position. With such a structure, more connection points can be generated between the frame portion 210 and the main body portion 110, so that the contact area between the frame portion 210 and the main body portion 110 is larger, and the connection between the frame portion 210 and the main body portion is more stable; further, the main body portion 110 is maximally distanced from the left ventricular outflow tract. The left-right connection structure can reduce the material of the frame portion 210 compared with the structure in which the frame portion is nested inside and outside, and is convenient to press and hold.

When the valve prosthesis of the present embodiment is implanted, the frame portion 210 should be disposed at a predetermined position near the left ventricular outflow tract.

Example 3

The present embodiment provides a valve prosthesis, which is an improvement on embodiment 1 or embodiment 2, wherein the frame portion 210 is configured as a non-closed structure.

As shown in FIG. 13, which is a top view of the frame portion 210, the frame portion 210 is a non-enclosed structure that is semi-circular or C-shaped in cross-section. The non-closed configuration can further save material in the frame portion 210, making the valve prosthesis easier to grip and transport.

As shown in fig. 14, which is a schematic perspective view of the bracket of the present embodiment, the frame portion 210 and the main body portion 110 are arranged side by side, wherein the frame portion 210 has an opening structure along the axial direction, and the frame portion 210 is connected to the outer periphery of the main body portion 110 at the opening.

The embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other. The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims. 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 their full scope and equivalents.

Claims

1. A heart valve prosthesis, comprising a valve, a stent;

the stent comprises a body portion for supporting a valve and a frame portion for securing the body portion at a native annulus, the body portion being connected with the frame portion; the frame portion includes an atrial segment deployed within an atrium, a valve ring segment deployed at an annulus, and a ventricular segment deployed within a ventricle; the ventricular segments include a first ventricular segment on a side proximal to the outflow tract, the first ventricular segment being spaced from an axis of the frame portion by a distance R1, wherein R1 tapers in a linear or non-linear manner in a direction from the atrium to the ventricle.

2. The heart valve prosthesis of claim 1, wherein a tangent of the first ventricular section includes an angle α with the axial direction, the angle α being in the range of 30 ° to 60 °.

3. The heart valve prosthesis of claim 1, wherein the body portion and the frame portion are in a nested configuration, the body portion nested inside, and a distance between an axis of the body portion and an axis of the frame portion is r, wherein r is greater than 0.

4. The heart valve prosthesis of claim 3, wherein the body portion is distal to the outflow tract and abuts the frame portion.

5. The heart valve prosthesis of claim 1, wherein the frame portion and the body portion are in a side-by-side configuration.

6. The heart valve prosthesis of any of claims 1-5, wherein the frame portion is a non-closed structure.

7. The heart valve prosthesis of claim 6, wherein the frame portion is an open structure in an axial direction, and the frame portion is connected to a peripheral side of the body portion at the opening.

8. The heart valve prosthesis of claim 1, wherein the stent further comprises a fixation portion secured to the delivery system, the fixation portion disposed at an end of the body portion or at an end of the frame portion.

9. The heart valve prosthesis of claim 1, wherein the valve includes a prosthetic leaflet disposed in the body portion.

10. The heart valve prosthesis of claim 1, wherein the stent is further provided with a skirt for sealing.