CN115737202A

CN115737202A - Artificial heart valve device

Info

Publication number: CN115737202A
Application number: CN202111033894.0A
Authority: CN
Inventors: 石若璘
Original assignee: Zhixin Medical Technology Shanghai Co ltd
Current assignee: Zhixin Medical Technology Shanghai Co ltd
Priority date: 2021-09-03
Filing date: 2021-09-03
Publication date: 2023-03-07

Abstract

The invention provides a prosthetic heart valve device which comprises an outer layer support, an inner layer valve support, an isolation bridge structure, valve leaves and a skirt edge. The outer layer support is sleeved on the outer side of the inner layer valve support through an isolation bridge structure, the valve leaves are arranged on the inner side of the inner layer valve support, and the skirt edges are attached to the inner side and the outer side of the outer layer support and the inner side of the inner layer support. Wherein, keep apart the bridge structure and include a plurality of isolation bridges, a plurality of isolation bridges set up along outer support circumference, and keep apart the bridge and have first end and second end, outer support is connected to first end, the inlayer support of inlayer valve support is connected to the second end, first end and second end have the clearance in outer support's radial, in order to realize through keeping apart the bridge structure that the deformation volume of outer support and the deformation volume of inlayer support are relatively independent, make outer support can be designed to have better flexibility and compliance and need not to worry its deformation and influence the apparatus life of valve leaf, still make the heart valve prosthesis device can adapt to more extensive disease crowd, and for it provides reliable and stable treatment.

Description

Artificial heart valve device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a heart valve prosthesis device which belongs to an interventional type transcatheter.

Background

The existing interventional valve replacement device is usually composed of a support made of a metal material and valve leaves attached to the support, wherein in order to enable the artificial heart valve to have better sealing performance, the support needs to be pre-shaped to a certain extent according to the anatomical structure characteristics of the valve and deform to a certain extent after being implanted, so that the purpose of sealing is achieved by better attaching native tissues. The fluid properties of the structure and the durability of the material of the valve leaflet attached to the stent place certain limits on the amount of deformation that occurs after implantation of the stent. When the stent is greatly deformed after being implanted, the sealing performance of the valve leaflets and the service life of the device are significantly affected.

For aortic valve replacement devices, the native leaflets are often associated with calcification, resulting in the cross-section of the implanted aortic valve stent often being compressed into an oval shape. For mitral valve replacement devices, whose native mitral valve annulus is saddle-shaped, due to the large variation between patients, there is a risk of paravalvular leakage at the junction of the anterior and posterior leaflets of the mitral valve for stents that cannot be deformed to match the morphology of the annulus.

In order to solve the above problems, a double-layered stent valve design is adopted, such as the mayonnaise Intrepid mitral valve prosthesis, which adopts a softer outer stent to match the tissue morphology and an inner stent with a certain strength to attach the valve leaflets. However, since the outer bracket and the inner bracket are rigidly connected together by riveting or welding, the deformation of the outer bracket exceeding a certain amount still has a great influence on the inner bracket inside.

Disclosure of Invention

The invention aims to provide a prosthetic heart valve device which can reduce the influence of the deformation of an outer layer bracket on an inner layer bracket and a valve leaf, can provide stable and effective sealing performance when treating a case with larger individual difference, and does not lose the service life of an apparatus.

In order to solve the above problems, the present invention provides a prosthetic heart valve device, which is anchored on the mitral valve annulus at the junction of the left atrium and the left ventricle during operation, and comprises an outer layer support, an inner layer valve support, an isolation bridge structure, valve leaflets and a skirt, wherein the outer layer support is sleeved on the outer side of the inner layer valve support through the isolation bridge structure, the valve leaflets are arranged on the inner side of the inner layer valve support, the skirt is attached to the outer layer support and/or the inner layer valve support,

wherein, the isolation bridge structure includes a plurality of isolation bridges, and a plurality of isolation bridges are followed outer support circumference sets up, just the isolation bridge has first end and second end, first end is connected outer support, the second end is connected the inlayer support of inlayer valve support, first end and second end are in the radial clearance that has of outer support.

Optionally, a plurality of the isolation bridges are uniformly arranged along the circumferential direction of the outer layer bracket.

Optionally, the number of the isolation bridges is 3 to 30.

Optionally, the isolation bridge is formed by at least 1 flexible connecting rod.

Further, when the number of the flexible connecting rods is 1, the isolation bridge is I-shaped along the axial direction; and

when the quantity of flexible connecting rod is 2 at least, 2 at least flexible connecting rod is V-arrangement, N shape or M shape along the axial direction after end to end links up in proper order.

Furthermore, the number of the flexible connecting rods is 2, and the isolation bridge is V-shaped along the axial direction.

Optionally, the outer stent has two forms, namely a crimped state and an expanded state, in which the axial dimension of the outer stent is increased and the circumferential diameter of the outer stent is decreased, and in which the axial dimension of the outer stent is decreased and the circumferential diameter of the outer stent is increased.

Further, the inner-layer valve support comprises an inner-layer support and a valve, the valve is attached to the inner side of the inner-layer support along the circumferential direction,

the inner layer support is formed by connecting a plurality of structural units, is tubular, and is a latticed structural unit or a wavy structural unit.

Further, outer layer support includes and is formed by a plurality of constitutional unit interconnect, just outer layer support is the tubulose, outer layer support's constitutional unit is latticed constitutional unit or wave constitutional unit.

Further, during the transportation process, the gap between the first end and the second end becomes smaller, and the isolation bridge is embedded into the structural unit of the outer stent or the structural unit of the inner stent.

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

the invention provides a heart valve prosthesis device which comprises an outer layer support, an inner layer valve support, an isolation bridge structure, valve leaves and a skirt edge, wherein the outer layer support is sleeved outside the inner layer valve support through the isolation bridge structure, the valve leaves are arranged inside the inner layer valve support, the isolation bridge structure comprises a plurality of isolation bridges, the isolation bridges are arranged along the circumferential direction of the outer layer support, the isolation bridges are provided with first ends and second ends, the first ends are connected with the outer layer support, the second ends are connected with the inner layer support of the inner layer valve support, and gaps are formed between the first ends and the second ends in the radial direction of the outer layer support, so that the deformation quantity of the outer layer support and the deformation quantity of the inner layer support are relatively independent through the isolation bridge structure, the outer layer support can be designed to have better flexibility and compliance, the deformation of the outer layer support does not need to affect the service life of the valve leaves, the heart valve prosthesis device can adapt to a wider disease group, and a stable and reliable treatment effect can be provided for the heart valve prosthesis device.

Drawings

FIG. 1 is a schematic diagram of a left heart structure according to an embodiment of the present invention;

FIG. 2 is a schematic view of a prosthetic heart valve device according to one embodiment of the present invention in a left heart configuration;

FIG. 3 is a schematic perspective view of a prosthetic heart valve device according to an embodiment of the present invention;

FIG. 4 is a schematic cross-sectional view of a prosthetic heart valve device according to an embodiment of the present invention;

FIG. 5 is a simplified schematic illustration of a prosthetic heart valve device according to one embodiment of the present invention;

FIG. 6 is a schematic view of the structure of an outer stent and an inner stent according to an embodiment of the present invention;

FIG. 7 is a schematic view of a valve leaflet according to an embodiment of the invention;

FIG. 8 is a schematic structural diagram of an isolation bridge according to an embodiment of the present invention;

fig. 9a-9c are schematic structural diagrams of an isolation bridge according to an embodiment of the invention under different viewing angles.

Description of reference numerals:

1-a prosthetic heart valve device; 2-left atrium; 3-valve leaflets; 4-mitral valve annulus; 5-papillary muscle; 6-left ventricle; 7-left ventricular outflow tract;

10-outer layer support; 20-inner valve stent; 21-inner layer support; 22-a valve; 30-an isolation bridge structure; 31-an isolation bridge; 40-valve leaflet; 50-skirt edge;

101-outer inflow section; 102-outer outflow tract section; 103-barb structure; 104-a first fixed structure; 211-inner layer inflow channel; 212-inner outflow tract; 213-a second fixation structure; 310-a first end; 320-a second end; 311-Flexible connecting rod.

Detailed Description

A prosthetic heart valve device of the present invention will be described in further detail below. The present invention will now be described in more detail with reference to the accompanying drawings, in which preferred embodiments of the invention are shown, it being understood that one skilled in the art may modify the invention herein described while still achieving the advantageous effects of the invention. Accordingly, the following description should be construed as broadly as possible to those skilled in the art and not as limiting the invention.

In the interest of clarity, not all features of an actual implementation are described. In the following description, well-known functions or constructions are not described in detail since they would obscure the invention in unnecessary detail. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific details must be set forth in order to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art.

In order to make the objects and features of the present invention more comprehensible, embodiments of the present invention are described in detail below with reference to the accompanying drawings. It is to be noted that the drawings are in a very simplified form and are all used in a non-precise ratio for the purpose of facilitating and distinctly aiding in the description of the embodiments of the invention. As used herein, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The terms "inner", "outer", and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

Fig. 1 is a schematic structural diagram of the left heart structure of the present embodiment. As shown in fig. 1, the left heart structure is composed of a left atrium 2, a left ventricle 6, a mitral valve annulus 4 at the junction of the left atrium 2 and the left ventricle 6, mitral valve leaflets 3 attached thereto, papillary muscles 5 located in the left ventricle 6, chordae tendineae thereof, and the like. A healthy heart pumps blood from the left atrium 2 into the left ventricle 6 and the leaflets 3 ensure a unidirectional flow of blood, eventually exiting through the left ventricular outflow tract 7. Due to mitral valve disease, the leaflets 3 do not fully ensure one-way flow of blood within the heart, resulting in mitral regurgitation.

Fig. 2 is a schematic structural view of the left heart structure of the heart valve prosthesis device of the present embodiment. As shown in fig. 2, the present embodiment provides a prosthetic heart valve device 1 that, by being implanted transcatheter into the heart and ultimately anchored to the mitral annulus 4, the prosthetic heart valve device 1 replaces the leaflets 3 to ensure unidirectional blood flow to heal mitral regurgitation. The heart valve prosthesis device 1 has two forms, a deployed form when in normal operation and a crimped form when compressed for insertion into a sheath, so that the heart valve prosthesis device 1 is switched between a compressed state and an expanded state.

Fig. 3 is a schematic perspective view of a heart valve prosthesis device according to the present embodiment. Fig. 4 is a schematic cross-sectional view of a heart valve prosthesis device according to the present embodiment. Fig. 5 is a simple schematic view of the heart valve prosthesis device of the present embodiment. As shown in fig. 3-5, the prosthetic heart valve device 1 includes an outer stent 10, an inner valve stent 20, an isolation bridge structure 30, valve leaflets 40, and a skirt 50. The outer-layer stent 10 is sleeved on the outer side of the inner-layer valve stent 20, and the valve leaflets 40 are arranged on the inner side of the inner-layer valve stent 20.

The outer layer stent 10 is composed of structural units with changeable axial forms, such as grid structural units or wave structural units, and the like, and is composed of at least one row of structural units which are mutually connected in the circumferential direction in the axial direction, and a plurality of rows of units in the axial direction can be mutually and directly connected or indirectly connected. Preferably, the grid-shaped structural units can be rhombic, pentagonal, hexagonal and the like, which can form a closed-shaped structural unit.

The outer stent 10 has two forms of a crimped state in which the axial dimension of the outer stent 10 is increased and the circumferential diameter is decreased, and an expanded state in which the axial dimension of the outer stent 10 is decreased and the circumferential diameter is increased.

Fig. 6 is a schematic structural view of the outer layer stent and the inner layer stent of the present embodiment. As shown in fig. 6, the outer stent 10 includes an outer inflow channel section 101 and an outer outflow channel section 102 connected in the axial direction, the outer inflow channel section 101 is disposed near the left atrium 2, the outer inflow channel section 101 corresponds to a portion where blood flows into the prosthetic heart valve device 1 during valve operation, and the circumferential diameter of the outer inflow channel section 101 is gradually reduced from the left atrium 2 toward the left ventricle 6 to match the size change of the inner wall of the heart from the left atrium 2 to the mitral annulus 4. The outer outflow tract section 102 is disposed close to the left ventricle 6, the outer outflow tract section 102 corresponds to a portion of the prosthetic heart valve device from which blood flows out during valve operation, the circumferential diameter of the outer outflow tract section 102 gradually increases from the left atrium 2 toward the left ventricle 6, and gradually decreases after exceeding the opening size of the mitral valve annulus 4, so as to achieve morphological anchoring of the outer stent 10 without affecting blood flow outflow from the left ventricle outflow tract 7.

The outer flow inlet segment 101 flares away from the outer flow outlet segment 102 and extends away from the inner valve support 20 to cover the inner wall of the heart at the mitral annulus 4. The shape enables the outer layer inflow channel section 101 to have good flexibility so as to be attached to a native anatomical structure to achieve better immediately postoperative sealing performance, promote tissue growth, and achieve better endothelialization and long-term sealing performance. The shape of the outer layer inflow channel section 101 may be a circular, D-shaped or oval design, and preferably, the shape of the outer layer inflow channel section 101 is a circular shape, so as to eliminate the circumferential alignment requirement during surgical implantation.

Outer layer support 10 still includes barb structure 103, barb structure 103 sets up on outer layer inflow canal section 101 or outer outflow canal section 102 keep away from the lateral wall of inner layer valve support 20, and evenly sets up along outer layer support 10's circumference, barb structure 103's one end is connected on outer layer inflow canal section 101 or outer outflow canal section 102, and the other end is the free end, the free end sets up towards left atrium 2 for it is supplementary to anchor outer layer support 10 in native tissue.

Optionally, the end of the outer flow channel segment 101 away from the outer flow channel segment 102 or the end of the outer flow channel segment 102 away from the outer flow channel segment 101 has a first fixing structure 104, and the first fixing structure 104 is used for connecting a delivery system for delivering the prosthetic heart valve device 1.

The inner valve stent 20 comprises an inner stent 21 and a valve circumferentially attached to the inside of the inner stent 21. The inner stent 21 is tubular to provide an attachment environment for the valve leaflets 40 and skirt 50. The inner valve stent 20 has significant radial and axial stiffness and can withstand the pulling of the valve leaflets 40. The inner layer stent 21 is composed of structural units such as grid structural units or wave structural units, etc., which can change in axial form. The axial direction of the device consists of at least one row of structural units which are mutually connected in the circumferential direction, and the plurality of rows of units in the axial direction can be directly connected or indirectly connected with each other. The inner layer stent 21 is made of biocompatible materials with shape memory characteristics such as nickel titanium and the like, or biocompatible materials such as cobalt-chromium alloy, stainless steel and the like, and is manufactured by the processes of heat treatment, sand blasting, polishing or other processes capable of processing stents after cutting. When the inner layer support 21 is made of nickel-titanium materials, the rigidity of the inner layer support 21 can be enhanced by increasing the wall thickness and the rod width, adjusting the phase transition temperature point and the like, so that the fatigue performance of the valve leaf is ensured.

The inner layer support 21 comprises an inner layer inflow channel 211 and an inner layer outflow channel 212 which are connected along the axial direction, wherein the inner layer inflow channel 211 is arranged close to the left atrium 2 and corresponds to the inner layer support part of the artificial heart valve device into which blood flows when the valve is operated; the inner outflow tract 212 is positioned adjacent the left ventricle 6 and corresponds to the inner stent portion of the prosthetic heart valve device through which blood flows during valve operation.

The inner outflow channel 212 has a tubular structure, and the portion of the inner outflow channel 212 connected to the inner inflow channel 211 has the same size. Optionally, the portion of the inner outflow tract 212 radially away from the inner inflow tract 211 is flared away from the inner outflow tract 212 and extends toward the outer stent 10, i.e., the end of the inner outflow tract 211 near the left atrium 2 may curve circumferentially outward to provide a smoother blood flow path. The inner outflow tract 212 connects the valve leaflets 40 and the inside of the inner stent 21 is stably connected to the valve.

Optionally, the end of the inner layer inflow channel 211 remote from the inner layer outflow channel 212 or the end of the inner layer outflow channel 212 remote from the inner layer inflow channel 211 has a second fixing structure 213, and the second fixing structure 213 is used for connecting a delivery system for delivering the prosthetic heart valve device 1.

Fig. 7 is a schematic structural view of a valve leaflet of the present embodiment. As shown in fig. 7, the number of the valve leaflets 30 is at least two, and in this embodiment, the number of the valve leaflets 30 is three. The valve leaflet 30 is made of animal pericardium or other biocompatible polymer materials, one end of the valve leaflet 30 is directly or indirectly stably connected with the inner-layer stent 21, the other end of the valve leaflet 30 is a free end, and the free end protrudes towards one side, away from the inner-layer outflow channel 212, of the inner-layer inflow channel 211, so that the whole of at least two valve leaflets 30 is in a bowl shape. The valve leaflet 30 is attached to the inner outflow channel 212, and in an operating state, the valve leaflet 30 replaces the native valve leaflet to realize the function of opening and closing a blood channel so as to realize the unidirectional passage of blood flow.

Referring to fig. 6, the skirt 50 is a thin film attached to the inner surface or the outer surface of the stent and having the function of preventing perivalvular leakage, etc., the outer stent 10 and the inner stent 21 may both have the skirt 50, and the skirt 50 is disposed at the end of the outer stent 10 close to the left ventricle and/or close to the left atrium, and is also disposed at the end of the inner stent 21 close to the left ventricle and/or close to the left atrium. The skirt 50 is used to assist in sealing the inner valve stent 20.

Fig. 8 is a schematic structural diagram of the isolation bridge of the present embodiment. Fig. 9a is a schematic view of the structure of the isolation bridge of fig. 8 from the AA perspective. Fig. 9b is a schematic front view of the isolation bridge of the present embodiment. Fig. 9c is a schematic top view of the isolation bridge of the present embodiment. As shown in fig. 8-9c, referring to fig. 6, the prosthetic heart valve device 1 further includes an isolation bridge structure 30, wherein the isolation bridge structure 30 connects the outer stent 10 and the inner stent 21.

The isolation bridge structure 30 includes a plurality of isolation bridges 31, and the number of the isolation bridges 31 is 3 to 30. The plurality of isolation bridges 31 are uniformly arranged along the circumferential direction of the outer stent 10, are positioned between the outer stent 10 and the inner stent 21, and are used for connecting the outer stent 10 and the inner stent 21. The isolation bridge 31 has two ends, namely a first end 310 and a second end 320, and a gap is formed between the first end 310 and the second end 320, so that the deformation of the outer stent 10 and the deformation of the inner stent 21 are relatively independent through the isolation bridge structure 30, the outer stent 10 can be designed to have better flexibility and compliance without worrying about the influence of the deformation on the device life of valve leaflets, the artificial heart valve device 1 can adapt to wider disease groups, and a stable and reliable treatment effect is provided for the artificial heart valve device. In addition, the inner layer stent 21 can provide more stable attachment for the valve leaflet under the connection of the isolation bridge structure 30, and improves the hemodynamic performance and the service life of the artificial heart valve device 1. Compared with the direct rigid connection between the outer bracket 10 and the inner bracket 21, the present embodiment connects the outer bracket 10 and the inner bracket 21 through the isolation bridge structure 30, which can connect the outer bracket 10 with a larger deformation amount on the premise of having a smaller rigidity, and also enables the inner bracket 21 to have a smaller radial dimension in the crimped state. Further reducing the overall sheath size of the prosthetic heart valve device 1 reduces the likelihood of vascular complications in the patient during transcatheter treatment.

The isolation bridge 31 is formed by at least 1 flexible connection bar 311. When the isolation bridge 31 is formed by 1 flexible connection rod 311, the isolation bridge 31 is I-shaped in the axial direction; when the quantity of flexible connecting rod 311 is 2 at least, 2 at least flexible connecting rod 311 links up end to end in proper order and forms structures such as V-arrangement, N shape, M shape, can also be that more flexible connecting rods 311 form, and it only needs to satisfy isolation bridge 31 and has both ends and have the clearance between the both ends, and both ends are in the footpath of outer support 10 is not overlapped. As shown in fig. 8-9c, in the present embodiment, the isolation bridge 31 is formed by 2 flexible connection rods 311 to form the isolation bridge 31 in a V-shaped structure. When the outer stent 10 is in the crimped state, the isolation bridge 31 deforms, and the radial distance between the two ends along the outer stent 10 decreases, so that the isolation bridge 31 can be completely embedded into the structural unit of the outer stent 10 or the inner stent 21, the isolation bridge 31 does not occupy the radial space of the conveying sheath in the conveying process, and the size of the whole sheath of the artificial heart valve device 1 is reduced. It should be noted that the V-shaped, N-shaped, M-shaped, etc. structures are the structural shapes shown in the axial direction of the isolation bridge 31, for example, the V-shaped isolation bridge 31 shown in fig. 9a from the axial view in the embodiment, but as shown in fig. 9b to 9c, the isolation bridge 31 at other view angles may observe other shapes, not the V-shape.

The first end 310 is connected to the outer stent 10, for example, at the intersection of the structural units of the outer stent 10, and the second end 320 is connected to the inner stent 21, for example, at the intersection of the structural units of the inner stent 21. For the convenience of preparation, the isolation bridge 31 and the outer layer bracket 10 are integrally cut and connected to the inner layer bracket 21 through riveting or welding; or, the isolation bridge 31 and the inner layer bracket 21 are integrally cut and connected to the outer layer bracket 10 by riveting or welding.

The material of the isolation bridge 31 is the same as that of the outer stent and the inner stent, for example, a biocompatible material with shape memory property such as nickel titanium or a biocompatible material such as cobalt-chromium alloy and stainless steel is used.

In summary, the invention provides a prosthetic heart valve device, and a design of a double-layer stent valve and an isolation bridge structure of the prosthetic heart valve device, wherein an isolation bridge structure is added between an outer stent and an inner stent, so that the influence of the deformation of the outer stent after implantation on the inner stent and valve leaflets attached to the inner stent is minimized, and the design can stably and effectively provide sealing performance without losing the service life of instruments when treating cases with large individual differences.

In addition, it should be noted that the terms "first" and "second" in the specification are only used for distinguishing each component, element, step and the like in the specification, and are not used for indicating a logical relationship or a sequential relationship between each component, element, step and the like, unless otherwise specified or indicated. It is to be understood that while the present invention has been described in conjunction with the preferred embodiments thereof, it is not intended to limit the invention to those embodiments. It will be apparent to those skilled in the art that many changes and modifications can be made, or equivalents employed, to the presently disclosed embodiments without departing from the intended scope of the invention. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention are still within the scope of the protection of the technical solution of the present invention, unless the contents of the technical solution of the present invention are departed.

Claims

1. A prosthetic heart valve device is anchored on a mitral valve annulus at the junction of the left atrium and the left ventricle when in work and is characterized by comprising an outer layer support, an inner layer valve support, an isolation bridge structure, valve leaves and a skirt edge, wherein the outer layer support is sleeved on the outer side of the inner layer valve support through the isolation bridge structure, the valve leaves are arranged on the inner side of the inner layer valve support, the skirt edge is attached to the outer layer support and/or the inner layer valve support,

2. The prosthetic heart valve device of claim 1, wherein a plurality of the isolation bridges are uniformly disposed along a circumferential direction of the outer stent.

3. The prosthetic heart valve device of claim 1, wherein the number of isolation bridges is between 3 and 30.

4. The prosthetic heart valve device of claim 1, wherein the isolation bridge is formed from at least 1 flexible connecting rod.

5. The prosthetic heart valve device of claim 4,

when the number of the flexible connecting rods is 1, the isolation bridge is I-shaped along the axial direction; and

6. The prosthetic heart valve device of claim 5, wherein the number of the flexible connecting rods is 2, and the isolation bridge is V-shaped in an axial direction.

7. The prosthetic heart valve device of claim 1, wherein the outer stent has two configurations, a crimped state in which the outer stent increases in axial dimension and decreases in circumferential diameter, and an expanded state in which the outer stent decreases in axial dimension and increases in circumferential diameter.

8. The prosthetic heart valve device of claim 7, wherein the inner layer valve stent comprises an inner layer stent and a valve circumferentially attached to an inner side of the inner layer stent,

9. The prosthetic heart valve device of claim 8, wherein the outer stent comprises a plurality of structural units interconnected to form a tubular shape, and wherein the structural units of the outer stent are lattice structural units or wave structural units.

10. The prosthetic heart valve device of claim 9, wherein a gap between the first end and the second end is reduced during delivery, and the isolation bridge is embedded into a structural unit of the outer stent or a structural unit of the inner stent.