CN114191146A

CN114191146A - Valve support and artificial valve device comprising same

Info

Publication number: CN114191146A
Application number: CN202111666612.0A
Authority: CN
Inventors: 徐海洋; 尹安远
Original assignee: Shanghai Lanfan Boao Medical Technology Co ltd
Current assignee: Shanghai Lanfan Boao Medical Technology Co ltd
Priority date: 2021-12-31
Filing date: 2021-12-31
Publication date: 2022-03-18

Abstract

The present disclosure provides a valve stent comprised of a plurality of diamond-shaped meshes. Each rhombic grid consists of four wave bars, the valve stent has a compression state and an expansion state, a first area and a second area are sequentially connected from an outflow end to an inflow end along the axial direction of the valve stent, the first area is provided with a frustum structure gradually reduced towards the outflow end, the outflow end is provided with a plurality of V-shaped structures, each V-shaped structure consists of two connected wave bars, and each wave bar is of a deflection structure around the wave bar. The second region has a tubular configuration, and an axially intermediate position of the second region includes an annulus mounting region for fixation to the native annulus. The present disclosure also provides a prosthetic valve device including the valve stent and the prosthetic valve leaflet as described above. The prosthetic leaflet is attached to the inner surface of the valve stent and is secured to at least the transition region between the first region and the second region. The outflow end of the valve support according to the embodiment of the disclosure can be integrally in a vortex shape and slightly retracted radially inwards along with the opening and closing of the artificial heart valve, so that the stress at the valve leaflet can be obviously reduced, and the potential risk of calcified deposition of the valve leaflet is reduced.

Description

Valve support and artificial valve device comprising same

Technical Field

The present disclosure relates to medical devices, and more particularly, to valve stents and prosthetic valve devices for transcatheter valve replacement.

Background

The heart valve is a core component of the heart, and is continuously opened and closed in the working process of the heart so as to realize normal blood circulation, when the valve is changed due to congenital or acquired diseases, the valve cannot be normally opened and closed, so that great influence is caused on the health and life of people, and the heart cannot normally work due to serious valve diseases, and the artificial heart valve needs to be replaced.

Currently, artificial biological heart valves are mainly used, which are mainly classified into surgical implantation type and transcatheter intervention type according to the characteristics of implantation into the human body. The interventional artificial biological heart valve is pre-pressed into a catheter, and is installed to a designated position through a valve conveying device through a path such as an aorta or a small apical opening, so that the interventional artificial biological heart valve has the advantages of short operation time, no need of stopping and jumping of the heart, less blood loss and the like, and is obviously reduced in trauma and more popular compared with an implanted artificial valve in a surgical operation. However, the interventional bioprosthetic heart valve also has the problem of calcification and deposition of valve leaflets, so that the service life of the current bioprosthetic heart valve can only reach 10 years at most, and after the bioprosthetic heart valve fails, a patient needs to face secondary operation and corresponding risks.

Disclosure of Invention

In order to solve the problems, the valve support and the artificial valve device are provided, the outflow end with the frustum structure and the flexible deflectable wave rod are adopted, and the stress at the valve leaflet is obviously reduced, so that the potential calcification deposition risk of the valve leaflet is reduced, and the service life of the product is prolonged.

The present disclosure provides a valve stent comprised of a plurality of diamond-shaped meshes. Each rhombic grid consists of four wave bars, the valve stent has a compression state and an expansion state, a first area and a second area are sequentially connected from an outflow end to an inflow end along the axial direction of the valve stent, the first area is provided with a frustum structure gradually reduced towards the outflow end, the outflow end is provided with a plurality of V-shaped structures, each V-shaped structure consists of two connected wave bars, and each wave bar is of a deflection structure around the wave bar. The second region has a tubular configuration, and an axially intermediate position of the second region includes an annulus mounting region for fixation to the native annulus.

In one embodiment, the deflection angle of the wave bar is 2 ° to 10 °.

In one embodiment, the two wave bars in the V-shaped structure deflect in the same direction.

In one embodiment, the material of the valve stent is a shape memory material or a superelastic material.

In one embodiment, a transition region is arranged between the first region and the second region, the transition region is provided with at least two valve fixing holes along the circumferential direction of the valve support, and the at least two valve fixing holes are uniformly distributed along the circumferential direction of the valve support.

In one embodiment, the annulus mounting region has a diameter that is smaller than the diameter of the valve holder at other locations; and/or the diamond-shaped lattice of the annulus mounting region is smaller than the diamond-shaped lattice at other locations of the valve stent.

In one embodiment, a plurality of radiopaque visualization points are distributed along the circumference of the valve stent at the annulus mounting region.

In one embodiment, the valve stent has a height of 28mm to 50 mm; the diameter of the end part of the outflow end of the first area is 20-30 mm; the diameter of the valve ring installation area is 18 mm-28 mm.

The present disclosure also proposes a prosthetic valve device comprising a valve stent as described in any of the above embodiments and a prosthetic leaflet. The prosthetic leaflet is attached to the inner surface of the valve stent and is secured to at least the transition region between the first region and the second region.

In one embodiment, the valve stent is configured such that as the prosthetic leaflet closes, the angle of deflection of the wave bars increases and the radial dimension of the first region decreases.

The outflow end of the valve support according to the embodiment of the disclosure can be integrally in a vortex shape and slightly retracted radially inwards along with the opening and closing of the artificial heart valve, so that the stress at the valve leaflet can be obviously reduced, the potential risk of calcification and deposition of the valve leaflet is reduced, the treatment effect of the artificial valve device is improved, and the service life of the artificial valve device is prolonged.

Drawings

To more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly introduced below, and it is apparent that the drawings in the following description relate only to some embodiments of the present disclosure and are not limiting to the present disclosure.

Fig. 1 is a schematic view of a valve stent 100 according to one embodiment of the present disclosure.

Fig. 2a is a schematic top view of a first region 120 according to one embodiment of the present disclosure when the prosthetic leaflet is open.

Fig. 2b is a schematic top view of the first region 120 according to one embodiment of the present disclosure when the prosthetic leaflet is closed.

Detailed Description

The technical solutions in the embodiments of the present disclosure will be clearly and completely described below with reference to the drawings in the embodiments of the present disclosure, and it is obvious that the described embodiments are only a part of the embodiments of the present disclosure, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments disclosed herein without making any creative effort, shall fall within the protection scope of the present disclosure.

Unless otherwise defined, all terms (including technical and scientific terms) used in the embodiments of the present disclosure have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

The use of "first," "second," and similar terms in the embodiments of the disclosure is not intended to indicate any order, quantity, or importance, but rather to distinguish one element from another. The use of the terms "a" and "an" or "the" and similar referents do not denote a limitation of quantity, but rather denote the presence of at least one. Likewise, the word "comprising" or "comprises", and the like, means that the element or item listed before the word covers the element or item listed after the word and its equivalents, but does not exclude other elements or items. In the following description, spatial and orientational terms such as "upper", "lower", "front", "rear", "top", "bottom", vertical "and" horizontal "may be used to describe embodiments of the invention, but it is understood that these terms are merely used to facilitate the description of the embodiments shown in the drawings and do not require that the actual apparatus be constructed or operated in a particular orientation. In the following description, the use of terms such as "connected," "coupled," "secured," and "attached" may refer to two elements or structures being directly connected without other elements or structures therebetween, or indirectly connected through intervening elements or structures, unless expressly stated otherwise herein. It should be noted that the "diamond" in this document may be a diamond structure or a quadrilateral structure that approximates a diamond. The "wave bars" herein are the basic components of the lattice forming the valve stent, which may be straight bars or bars with a curvature. The term "outflow end" as used herein refers to the end to which blood flows through the valve; the "inflow end", i.e. the end from which blood flows into the valve, is the side closer to the aortic arch, for example, the aortic valve, and the inflow end is the side closer to the left ventricle.

Transcatheter Aortic Valve Implantation (TAVI) stent systems are currently in use on the market, such as: Venus-A, J-Valve, etc., all use a self-expanding stent as a support frame, and biological tissue valves, such as bovine pericardium and porcine pericardium, are sewed on the inner wall of the support frame. The designed product has excellent performance and convenient use, is accepted by most clinical experts, but has the problems of easy calcification, short service life and the like of biological tissues. When the TAVI system is used for a certain period of time, the valve failure needs to be confronted with a secondary operation, which brings great risk to the patient.

To this end, embodiments of the present disclosure provide a valve stent and a prosthetic valve device to solve the above technical problems, which can be described with particular reference to the following description.

Fig. 1 is a schematic view of a valve stent 100 according to one embodiment of the present disclosure. As can be seen, the valve stent 100 is constructed from a plurality of diamond-shaped cells 110, each diamond-shaped cell 110 being constructed from four struts 122, and each diamond-shaped cell being expandable. By "expandable" is meant that the area of the diamond-shaped cells 110 can be increased and decreased, respectively, when the valve stent 100 is radially expanded and radially contracted. The valve stent 100 has a compressed state and an expanded state. The valve stent 100 is provided with a first region 120 and a second region 130 which are sequentially connected from the outflow end to the inflow end along the axial direction. The first region 120 has a truncated cone structure that tapers towards the outflow end. The frustum structure here is, for example, a truncated cone (or called truncated cone), a truncated pyramid, or the like. In one embodiment, the frustum structure is a frustum, as shown. The second region 130 has a tubular configuration, and an axially intermediate position of the second region 130 includes an annulus mounting region 140 for fixation to a native annulus. As can be seen, the annulus mounting region 140 has a diameter that is smaller than the diameter of the valve holder at other locations. The diamond-shaped lattice 110 at the annulus mounting region 140 is smaller in size than the diamond-shaped lattice 110 at other locations of the valve stent 100 such that the lattice density at the annulus mounting region 140 is greater than the lattice density at other locations of the valve stent 100. The radial support strength of the valve stent 100 composed of diamond-shaped meshes 110 is greatly determined by the density of the meshes, and when the density of the meshes is higher, the radial support force of the valve stent 100 is higher, so that the annular safety zone of the valve stent 100 can be more firmly attached to the aortic annulus. It is to be noted that the "lattice density" herein refers to the number of lattices per unit area. "size" refers primarily to the area of the diamond-shaped mesh.

The outflow end has a plurality of V-shaped structures 124, the V-shaped structures 124 being formed by two wave bars 122 connected. The proximal ends of at least two of the plurality of V-shaped structures 124 have T-shaped connecting rods 128. The number of the corresponding T-shaped connecting rods 128 can be set according to actual needs. In one embodiment, as shown, the number of T-shaped connecting rods 128 is 3, and 3T-shaped connecting rods 128 are evenly distributed along the circumference of the valve stent 100. Each T-shaped connecting rod 128 comprises a rod extending circumferentially of the valve stent at its outflow end. In one embodiment, the rod at the outflow end of the T-shaped connecting rod 128 has a circular arc structure that curves around the central axis of the valve stent, so that the valve stent 100 in a compressed state is sufficiently attached to the anchor of the delivery system, the contour diameter of the attachment is greatly reduced by the local structure, and the valve system is safely anchored in the catheter. And due to the arc structural design, the timeliness of releasing and anchoring is effectively ensured while the safe anchoring is ensured, and the hooking phenomenon during the release of the valve in the operation is reduced.

The wave rod 122 of the present disclosure is itself flexible and has deflection characteristics, i.e., the wave rod 122 can deflect along its circumference. During systole and diastole, when the native aortic annulus contracts with the contraction movement of the left ventricle, the valve stent 100 contracts inward in the radial direction, thereby driving the wave rod 122 to further deflect in the circumferential direction, and making the deflection angle larger. In order to avoid the displacement of the stent, the valve stent in the prior art is usually designed to have high radial supporting force, for example, a crown structure design is adopted at the part of the valve stent corresponding to the outflow end, so that the overall rigidity of the valve stent is high. When the heart contracts and the valve leaflets close, the valve stent still tends to be spread radially outwards at the moment, which causes stress concentration on the valve leaflets, is easy to calcify and deposit and influences the service life of the valve leaflets. In the truncated cone design of the present disclosure, the diameter of the outflow end of the valve stent 100 is smaller and the amount of metal material is less than that of the conventional crown-type structure, so that the valve stent 100 has the necessary rigidity (support) and also has a certain flexibility. In other words, the valve stent 100 of the present disclosure is more compliant than existing more rigid (crown) valve stents. During systole and diastole, on the one hand, the native aortic annulus will have a correspondingly larger or smaller diameter, resulting in a change in the radial dimension of the self-expanding valve stent 100 secured against the native aortic annulus, e.g., as the heart undergoes a systolic motion, the aortic annulus will have a smaller diameter, and thus the diameter of the valve stent 100 (particularly at the outflow tract) will also have a correspondingly smaller diameter. In other words, the aortic blood vessels and the inner wall of the left ventricle around the aortic valve apply a force in the radial direction thereof to the valve stent 100 attached thereto, thereby making the radial diameter of the valve stent 100 smaller. It should be noted that wave bars 122 are flexible such that they can be slightly retracted radially inward of valve stent 100 during valve closure. On the other hand, the native aortic annulus and the blood vessel may apply a force to the valve stent 100 in its circumferential direction, which force, due to the flexibility of the valve stent 100 of the present disclosure, may cause the valve stent 100 to deflect in its circumferential direction against the proximal portion of the aortic wall, in other words, the wave bars 122 in the first region 120 deflect in the circumferential direction of the valve stent 100. Therefore, in practical operation, when the implanted artificial valve leaflet is closed, the wave bars 122 in the first region 120 are pulled to slightly retract in the radial direction of the valve support 100 at a certain deflection angle, so that the wave bars 122 at the outflow end can move locally along with the heart valve opening and closing movement, thereby transferring the stress generated by the pressure gradient from the artificial valve leaflet (which is a biological material and has unpredictable performance) to the valve support 100 (which is a synthetic material and has isotropic characteristic and predictable mechanical performance), so that the stress at the valve leaflet can be reduced remarkably, and the potential risk of calcific deposition of the valve leaflet is reduced. It should be noted that although the native aortic annulus and blood vessels may apply forces to the valve stent 100 in its circumferential direction, conventional crown stents are relatively less likely to collapse, resulting in stress concentrations on the valve leaflets. In summary, when the outflow end of the wave rod 122 deflects, the wave rod also moves in the circumferential direction and the radial inward direction of the valve stent 100, and at this time, the distal end (the end close to the inflow end) of the wave rod 122 in the first region 120 is restricted in movement due to the connection with the second region 130, so that each wave rod 122 deflects, inclines and bends simultaneously, the outflow end of the valve stent 100 is overall in a vortex shape and slightly retracts radially inward, and the stress accumulated on the valve leaflet is released. It should be noted that "deflection" in this context means that the outflow end of the wave rod is twisted in the circumferential direction of the wave rod, and does not mean that the wave rod is transformed into a bent form.

In one embodiment, the first region 120 has 6V-shaped structures 124, wherein the proximal ends of the 3V-shaped structures 124 have T-shaped connecting bars 128, and the T-shaped connecting bars 128 are evenly distributed along the circumference of the valve stent 100, and each T-shaped connecting bar 128 comprises a rod 129 extending along the circumference of the valve stent at its outflow end. Wherein the wave rod 122 deflects along itself. Taking the aortic valve as an example, when the left ventricle contracts, blood flows through the valve to the aorta, and the valve leaflets fixed to the valve stent 100 open, with the wave bars 122 in the initial position, as shown in fig. 2 a. When the diameter of the aortic annulus becomes smaller, the aortic blood vessels and the inner wall of the left ventricle around the aortic annulus exert forces in the radial and circumferential directions on the valve stent 100 attached thereto, so that the outflow ends of the wave bars 122 will also move in the circumferential and radially inward directions of the valve stent 100 when deflecting themselves. In other words, when the prosthetic valve leaflet is closed, the wave rod 122 is pulled to slightly retract in the radial direction of the valve support 100 by a certain deflection angle α, so that the wave rod 122 can move locally along with the opening and closing movement of the heart valve. At this time, each wave rod 122 deflects, tilts and bends simultaneously, as shown in fig. 2b, resulting in the outflow end of the valve stent 100 being overall in a vortex shape and slightly converging radially inward, i.e., the angle α of deflection of the position of the rod 129, thereby releasing the stress accumulated on the leaflets. In one embodiment, the deflection angle of the wave bar is 2 ° to 10 ° in the natural state. In one embodiment, both wave bars in the V-shaped structure 124 deflect in the same direction, e.g., both deflect in a clockwise direction or both deflect in a counter-clockwise direction.

In one embodiment, the valve stent 100 can be made of a shape memory material or a superelastic material. The shape memory material is, for example, a nickel titanium alloy, preferably nitinol. With this material, the valve stent 100 can self-expand from the contracted state to the expanded state, which can be achieved, for example, by applying thermal energy, other energy, etc., or by removing an external force (e.g., a compressive force). The valve stent 100 can be repeatedly compressed and re-expanded without damaging the structure of the stent. In addition, the valve stent 100 may be laser cut from a complete tubing stock or may be assembled from separately formed wave bar connections.

A transition region is disposed between the first region 120 and the second region 130, and the transition region is provided with at least two valve fixing holes 126 along the circumferential direction of the valve stent 100. At least two valve fixing holes 126 are uniformly distributed along the circumferential direction of the valve stent 100. The number of valve fixation holes 126 may be determined according to the number of valve leaflets. In one embodiment, the valve device is used in aortic valve replacement surgery, the number of valve leaflets (not shown) is 3, and the corresponding number of valve fixation holes 126 is 3, it should be noted that three valve leaflets in the valve are attached to the inner surface of the valve stent 100 and fixed with the valve fixation holes 126 at the transition region.

In one embodiment, a plurality of radiopaque visualization points 132 are distributed at the annulus mounting region 140 along the circumference of the valve stent 100, and the annulus mounting region 140 corresponds to the native annulus location, so that the valve stent 100 or the entire valve device has good visualization during implantation, positioning accuracy when the valve stent 100 is released is also improved, operation time is reduced, and operation risk is reduced. The material of the radiopaque imaging spot 134 is, for example, gold or platinum iridium. In one embodiment, the number of visualization points 132 may be set to 2-6, depending on the actual requirements and the size of the valve stent.

In one embodiment, the height of the valve stent 100 can be 28-50 mm, depending on the actual surgical needs. In order to ensure the support performance of the valve stent, the whole height of the traditional valve stent structure is high, the height range is 40-65 mm, and the part of the valve stent corresponding to the outflow port is designed to be a crown structure with a large outer diameter. After the valve stent is implanted into a diseased site, the original hemodynamics of the heart valve are easily influenced, and some valves possibly block branch vessels. The whole valve is long, the valve leaves are high in position, the blood flow perfusion of coronary artery blood vessels can be influenced, the thrombus occurrence rate is high, and the like. As described above, according to the present disclosure, by providing the annulus mounting region 140 on the valve stent 100 and increasing its lattice density, the radial support force of this region is made greater so that the annulus safety region 140 of the valve stent 100 can more firmly fit against the aortic annulus. Therefore, the valve stent 100 can be stably installed at the position of the aortic valve without the design of the crown-type outflow end, which greatly reduces the size of the valve stent 100, simplifies the structure of the stent, reduces the use amount of metal materials and reduces related complications. Here, "height" refers to a dimension along the axial direction of the valve holder 110.

The valve stent 100 with further optimized design can be selected according to the structural size requirements of the valve stent 100 for the actual operation. In one embodiment the diameter at the outflow end of the first section is 20-30 mm, i.e. the smallest diameter of the truncated cone structure is in the range 20-30 mm. Compared with the traditional crown-type outflow end design, the frustum structure design can further reduce the press-fitting diameter of the valve stent 100, so that the passing outer diameter of the artificial valve device is reduced. According to the physiological and anatomical characteristics of a patient population, if the blood vessel of a patient is thin, the diameter range of the frustum structure can be designed in a targeted manner, which cannot be realized by the traditional crown structure, because the outer diameter at the outflow end of the traditional crown structure is large and the metal consumption is large, but if the specification is smaller, the stent has insufficient support performance, and other problems such as valve leakage can be caused. In one embodiment, the annulus mounting region 140 has a diameter of 18mm to 28 mm. As described above, the diamond-shaped lattice 110 at the annulus region 140 has the highest density, i.e., the greater number of lattices per unit area, resulting in greater radial forces at the annulus region 140. Because the aortic valves of different patients have different sizes, the radial force of the annulus mounting region 140 required to securely mount the valve holder 110 on the native annulus is correspondingly different, so that the size of the aortic valve can be designed and selected appropriately for different patient groups, and the diameter of the annulus mounting region 140 can be adjusted, so that the annulus mounting region 140 can provide sufficient radial force, which facilitates better mounting and fixation of the valve holder 100 on the aortic valve. In addition, the local size of the valve stent 110 can be designed and fine-tuned within the above size range to accommodate different aortic valve structures according to the physiological anatomical features of different patient populations.

In light of the foregoing, the present disclosure also provides a prosthetic valve device. The artificial valve device comprises the valve support 100 and the artificial valve leaflet. The prosthetic leaflet is attached to the inner surface of the valve stent 100 and is secured to at least the transition region between the first region 120 and the second region 130. In one embodiment, valve stent 100 is configured such that as the prosthetic leaflet closes, the angle of deflection of the wave bars increases and the radial dimension of the first region 120 decreases. In the prosthetic valve device according to the embodiments of the present disclosure, the valve stent 100 is more compliant than a (crown) valve stent having higher rigidity. When the heart contracts and the leaflets close, the native aortic annulus and blood vessels exert forces circumferentially and radially inward on the valve stent 100, thereby reducing the radial diameter of the valve stent 100. Thus, when the outflow end of the flexible wave rod 122 deflects, the outflow end of the flexible wave rod 122 can simultaneously move along the circumferential direction and the radial inward direction of the valve stent 100, so that each wave rod 122 deflects, tilts and bends at the same time, the outflow end of the valve stent 100 is integrally vortex-shaped and slightly collected radially inward, the stress accumulated on the valve leaflet is released, the stress at the valve leaflet can be obviously reduced, the potential risk of calcification and deposition of the valve leaflet is reduced, and the service life of the valve leaflet is prolonged. It should be noted that the valve holders and prosthetic valve devices of the present disclosure can be used not only for aortic valves, but also for other valves, such as mitral valve and tricuspid valve.

The following points need to be explained:

(1) the drawings of the embodiments of the disclosure only relate to the structures related to the embodiments of the disclosure, and other structures can refer to common designs.

(2) Without conflict, embodiments of the present disclosure and features of the embodiments may be combined with each other to arrive at new embodiments.

The above is only a specific embodiment of the present disclosure, but the scope of the present disclosure is not limited thereto, and the scope of the present disclosure should be determined by the scope of the claims.

Claims

1. A valve stent (100) composed of a plurality of diamond-shaped meshes (110), each of the diamond-shaped meshes (110) being composed of four wave bars (122), the valve stent (100) having a compressed state and an expanded state, a first region (120) and a second region (130) being sequentially connected from an outflow end to an inflow end in an axial direction of the valve stent, wherein:

the first region (120) has a truncated cone structure tapering towards the outflow end, the outflow end having a plurality of V-shaped structures (124) consisting of two of said wave bars connected, each wave bar being in a deflected configuration around itself; and

the second region (130) has a tubular configuration, and an axially intermediate position of the second region (130) includes an annulus mounting region (140) for fixation to a native annulus.

2. The valve stent (100) according to claim 1, wherein the deflection angle of the wave bars is 2 ° to 10 °.

3. The valve stent (100) of claim 1, wherein two of the wave bars in the V-shaped structure (124) deflect in the same direction.

4. The valve stent (100) according to claim 1, wherein the material of the valve stent (100) is a shape memory material or a superelastic material.

5. The valve stent (100) according to claim 1, wherein a transition region is arranged between the first region (120) and the second region (130), the transition region is provided with at least two valve fixing holes (126) along the circumference of the valve stent (100), and the at least two valve fixing holes (126) are evenly distributed along the circumference of the valve stent (100).

6. The valve holder (100) of claim 1, wherein the annulus mounting region (140) has a diameter that is smaller than a diameter at other locations of the valve holder; and/or the presence of a gas in the gas,

the diamond-shaped cells (110) of the annulus mounting region (140) are smaller in size than the diamond-shaped cells (110) at other locations of the valve stent.

7. The valve stent (100) of claim 1, wherein a plurality of radiopaque visualization points (132) are distributed along a circumference of the valve stent at the annulus mounting region (140).

8. The valve stent (100) of claim 1,

the height of the valve stent (100) is 28-50 mm;

the diameter at the end of the outflow end of the first region (120) is 20-30 mm;

the diameter of the valve ring installation area (140) is 18-28 mm.

9. A prosthetic valve device, comprising:

the valve stent (100) of any one of claims 1 to 8; and

a prosthetic leaflet attached to an inner surface of the valve stent (100) and secured at least at a transition region between the first region (120) and the second region (130).

10. The prosthetic valve device of claim 9, wherein the valve stent (100) is configured such that as the prosthetic valve leaflet closes, the angle of deflection of the wave bars increases and the radial dimension of the first region (120) decreases.