CN114681139A

CN114681139A - Valve stent and prosthetic valve assembly

Info

Publication number: CN114681139A
Application number: CN202011615841.5A
Authority: CN
Inventors: 潘孔荣; 张存义; 张海; 张一�
Original assignee: Peijia Medical Technology Suzhou Co ltd
Current assignee: Peijia Medical Technology Suzhou Co ltd
Priority date: 2020-12-31
Filing date: 2020-12-31
Publication date: 2022-07-01

Abstract

A valve stent and prosthetic valve assembly, the valve stent comprising an inner stent and an outer stent connected to each other; the inner support comprises at least two first extension parts, and the first extension parts face the outer support and form a first angle with the inner support; the outer support comprises at least two second extending parts, and the second extending parts face to the inner support and form a second angle with the outer support; each first extension part is correspondingly connected with the second extension part; at least one of the first angle and the second angle is not a right angle. In this way, the present application can enhance the anchoring effect of the valve stent on native heart tissue.

Description

Valve stent and prosthetic valve assembly

Technical Field

The present application relates to the field of medical device technology, and in particular, to a valve stent and prosthetic valve assembly.

Background

A heart valve-like disorder is a very common heart disorder, such as valve damage that may be caused by rheumatic fever. With the aging and the increasing population, senile valvular disease and valvular lesion caused by coronary heart disease myocardial infarction are more and more common. These valvular lesions not only endanger life safety and affect quality of life, but also bring serious burden and stress to families and society.

Currently, a valve prosthesis can be implanted at a diseased heart valve by a heart valve replacement procedure, i.e. by an invasive, minimally invasive method, to replace the originally diseased heart valve of a patient. However, the valve holder is prone to displacement due to the high pressure of blood flow between the atrium and ventricle.

Disclosure of Invention

The technical problem that this application mainly solved provides a valve support and prosthetic valve subassembly, can strengthen the anchoring effect of valve support to native heart tissue.

In order to solve the technical problem, the application adopts a technical scheme that: providing a valve stent, wherein the valve stent comprises an inner stent and an outer stent which are connected with each other, the inner stent comprises at least two first extension parts, the first extension parts face to the outer stent and form a first angle with the inner stent; the outer support comprises at least two second extension parts, and the second extension parts face the inner support and form a second angle with the outer support; each first extension part is correspondingly connected with the second extension part; at least one of the first angle and the second angle is not a right angle.

The valve support further comprises a connecting piece, and the connecting piece is sleeved on the end portions of the first extending portion and the second extending portion and used for connecting and fixing the first extending portion and the second extending portion.

The connecting mode of the first extending part and the second extending part is any one or combination of welding, flat pressing, tooth pressing and riveting.

Wherein the first angle is 30-60 degrees, and the second angle is 30-60 degrees.

Wherein the first angle is equal to the second angle.

Wherein, the outer support still includes main part, shirt rim structure, transition member and anchor assembly, and the shirt rim structure is connected to the transition member and main part, and anchor assembly includes a plurality of barbs that set up on the outer support and radially outwards extend, and the barb is used for anchoring valve stent on the heart.

The outer support further comprises an auxiliary anchoring assembly, the auxiliary anchoring assembly is connected with the skirt structure and located between any two transition rods and used for providing radial force for the outer support.

Wherein the rigidity of the inner bracket is greater than that of the outer bracket.

Wherein, the valve stent is a mitral valve stent or a tricuspid valve stent.

In order to solve the above technical problem, another technical solution adopted by the present application is: a prosthetic valve assembly is provided that includes an interconnected prosthetic valve and the valve stent described above.

The beneficial effect of this application is: in contrast to the state of the art, the present application provides a valve stent comprising an inner stent and an outer stent connected to each other; the inner support comprises at least two first extending parts facing the outer support and forming a first angle with the inner support, the outer support comprises at least two second extending parts facing the inner support and forming a second angle with the outer support, each first extending part and each second extending part are correspondingly connected, and at least one of the first angle and the second angle is not a right angle; the connection of the inner support and the outer support is realized through the connection of the first extension part and the second extension part, and the stress of the connecting structure can be regulated and controlled through the angle of the first extension part and the second extension part, so that the connecting structure can provide radial supporting force for the outer support, and the anchoring effect of the valve support on native heart tissue is assisted to be enhanced.

Drawings

FIG. 1 is a front view of a valve stent according to an embodiment of the present application;

FIG. 2 is a schematic view of an axial configuration of an embodiment of the valve stent of the present application;

FIG. 3 is a simplified structural schematic of an embodiment of the valve stent of the present application;

FIG. 4 is a simplified schematic diagram of the connection structure of the inner and outer frames of the present application;

FIG. 5 is a cross-sectional view of the connection structure of the inner stent and the outer stent of the present application;

FIG. 6 is an axial view of another connection structure of the inner and outer frames of the present application;

FIG. 7 is a cross-sectional view of another connection structure of the inner stent and the outer stent of the present application;

FIG. 8 is a schematic top view of an embodiment of a valve stent of the present application;

FIG. 9 is a schematic front view of another embodiment of a valve stent of the present application;

FIG. 10 is a schematic view of an axial structure of another embodiment of a valve stent of the present application;

fig. 11 is a schematic view of a prosthetic valve assembly of the present application implanted within a heart.

Detailed Description

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

It should be noted that if descriptions related to "first", "second", etc. are provided in the embodiments of the present application, the descriptions of "first", "second", etc. are only used for descriptive purposes and are not to be construed as indicating or implying relative importance or implicitly indicating the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In addition, technical solutions between various embodiments may be combined with each other, but must be realized by a person skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination of technical solutions should be considered to be absent and not be within the protection scope of the present application.

In order to make the purpose, technical solution and effect of the present application clearer and clearer, the present application is further described in detail below with reference to the accompanying drawings and examples.

The present application provides a valve stent comprising an inner stent and an outer stent connected to each other; the inner support comprises at least two first extending parts facing the outer support and forming a first angle with the inner support, the outer support comprises at least two second extending parts facing the inner support and forming a second angle with the outer support, each first extending part and each second extending part are correspondingly connected, and at least one of the first angle and the second angle is not a right angle; the connection of the inner support and the outer support is realized through the connection of the first extension part and the second extension part, and the stress of the connecting structure can be regulated and controlled through the angle of the first extension part and the second extension part, so that the connecting structure can provide radial supporting force for the outer support, the anchoring effect of the valve support on native heart tissues is assisted to be enhanced, and the fitting degree of the valve support and the native heart tissues is improved.

Referring to fig. 1-2, fig. 1 is a front view of a valve stent, and fig. 2 is an axial view of the valve stent. The present application provides a valve stent 100, the valve stent 100 can support prosthetic leaflets, which can be considered as a frame structure supporting prosthetic leaflets, ensuring that the normal operation of the prosthetic leaflets is not affected during systole and diastole, and the prosthetic leaflets supported by the valve stent 100 are relatively fixed with respect to native heart tissue so that the prosthetic leaflets can assist in repairing and/or replacing the function of a defective native heart valve.

The valve stent 100 includes an inner stent 110 and an outer stent 130 connected to each other to form a main body frame structure supporting prosthetic leaflets. The inner support 110 is used for positioning and installing the prosthetic leaflet and can support the normal operation of the prosthetic leaflet; the outer stent 130 may be anchored to the native annulus region, securing the valve stent 100 relative to the native heart tissue, and the valve stent 100 in apposition to the native heart tissue. The valve stent 100 may be a mitral valve stent or a tricuspid valve stent, and is not particularly limited herein.

Optionally, the stiffness of inner bolster 110 is greater than the stiffness of outer bolster 130. The inner support 110 plays a role in supporting the prosthetic leaflet, and the inner support 110 is hard relative to the outer support 130, so that the inner support is not easy to deform when being pressed or extruded, and the normal operation of the prosthetic leaflet arranged in the inner support is not influenced; the outer stent 130 protects the inner stent 110 to a certain extent, and the outer stent 130 is relatively soft, so that the compression on the inner stent 110 when the prosthetic leaflets are closed can be reduced.

Alternatively, the inner stent 110 and the outer stent 130 may be laser cut from one or more tubes, but not specifically limited thereto, preferably from a shape memory metal tube, such as nitinol, etc., and the valve stent 100 formed using the shape memory metal tube may be self-expandable from a compressed state, i.e., the valve stent 100 formed using the shape memory metal tube is more readily self-expandable from a collapsed or constrained structural state to an expanded or in-use structural state. In other embodiments, the inner support 110 and the outer support 130 may also be made of wires, such as shape memory metal wires, which may be specifically arranged according to the actual application scenario and are not specifically limited herein.

Referring to fig. 3-4, fig. 3 is a simplified structural diagram of an embodiment of a valve stent of the present application, and fig. 4 is a simplified structural diagram of a connection structure between an inner stent and an outer stent of the present application. The inner bracket 110 provided by the present application has at least two first extending portions 111, the first extending portions 111 extend toward the outer bracket 130 and form a first angle α with the inner bracket 110; meanwhile, the outer bracket 130 provided by the present application has at least two second extending portions 131, and the second extending portions 131 extend toward the inner bracket 110 and form a second angle β with the outer bracket 130; the first extension 111 and the second extension 131 are connected to form the connection portion 200, and at least one of the first angle α and the second angle β is not a right angle. Through the specific angle of adjusting and setting first angle alpha and second angle beta, can make connecting portion 200 give outer support 130 a radial holding power to strengthen valve support 100 to native heart tissue's anchoring effect, promote valve support 100 and native heart tissue's laminating degree, and can prevent the paravalvular leakage. The length L of the connecting portion 200 may be specifically set in an actual application scenario, and is not specifically limited herein. In one embodiment, the valve stent 100 comprises at least two connecting portions 200 formed by the first extending portion 111 and the second extending portion 131, and the at least two connecting portions 200 are distributed in the circumferential direction, so that the anchoring effect of the valve stent 100 on the native heart tissue is more stable.

Optionally, the first angle α and the second angle β are not both right angles, and both the first angle α and the second angle β may be acute angles, as shown in fig. 3, by setting the first angle α and the second angle β as acute angles, the connecting structure may be in a Z shape, and the Z-shaped connecting structure may provide a stable radial supporting force to the outer stent 130, assist in enhancing the anchoring effect of the valve stent 100 on the native heart tissue, so as to improve the fitting degree of the valve stent 100 and the native heart tissue.

Specifically, as shown in fig. 3, the native heart tissue contracts and expands in the cardiac cycle, and a force with a magnitude of F is generated to press the outer stent 130 in the valve stent 100, so that the relative position of the outer stent 130 and the native heart tissue changes, and since the inner stent 110 and the outer stent 130 are relatively fixed, the relative position of the inner stent 110 and the native heart tissue changes, so that the prosthetic leaflet supported on the valve stent 100 cannot perform a corresponding function. The first extending portion 111 and the second extending portion 131 form a zigzag-like coupling structure by adjusting the angles at which the first angle α and the second angle β are set, and the zigzag-like coupling structure can give a radial supporting force f to the outer bracket 130. When the valve stent 100 is compressed, the radial supporting force F can balance the compression acting force F applied to the valve stent 100, so that the valve stent 100 can move synchronously along with the movement of the native heart tissue, the relative position of the valve stent 100 and the native heart tissue is kept unchanged, namely, the valve stent 100 does not generate relative displacement relative to the native heart tissue, the anchoring effect of the valve stent 100 on the native heart tissue is assisted to be enhanced, the fitting degree of the valve stent 100 and the native heart tissue is improved, and perivalvular leakage is prevented.

Optionally, the first angle α is 30 ° -60 °, the second angle β is 30 ° -60 °, and specific degrees of the first angle α and the second angle β can be determined according to actual use requirements, and are not particularly limited herein. The first angle α and the second angle β are acute angles, and from another angle they can also be considered as obtuse angles. Specifically, taking the second angle β as an example, as shown in fig. 4, the second extending portion 131 extends toward the inner bracket 110 from the point O on the outer bracket 130 and forms a second angle β with the outer bracket 130, and the second angle β may be regarded as an acute angle, which is an angle formed by the second extending portion 131 and the OB section on the outer bracket 130, or an obtuse angle, which is an angle formed by the second extending portion 131 and the OA section on the outer bracket 130.

Further, the first extension part 111 and the second extension part 131 form a connecting structure similar to a zigzag shape, so that the axial length of the main body of the valve stent 100 can be reduced, and obstruction of ventricular outflow tracts caused by overlong axial length of the valve stent 100 is avoided; in the native cardiac cycle, the change in annular radial expansion is large, and the connection between the outer stent 130 and the inner stent 110 is located away from the native annular region, which can avoid the influence of annular radial expansion on the normal operation of the inner stent 110.

Referring to fig. 5, fig. 5 is a cross-sectional view illustrating a connection structure between an inner frame and an outer frame according to the present application. In this embodiment, the first extension 111 and the second extension 131 are overlapped and connected to form the connection portion 200. That is, from the ends of the first extension 111 and the second extension 131, a portion of the first extension 111 and a portion of the second extension 131 are overlapped and connected to achieve the connection fixation of the inner bracket 110 and the outer bracket 130. In other embodiments, the first extension portion 111 and the second extension portion 131 may also be fixedly connected end to end, and are not limited herein.

Alternatively, the overlapped ends of the first extension part 111 and the second extension part 131 may be fixed by one or more combinations of welding, flat pressing, tooth pressing, riveting, and the like, and the overlapped ends of the first extension part 111 and the second extension part 131 are not limited in this respect. For example, taking welding as an example, the end of the first extension portion 111 and the end of the second extension portion 131 are welded together to overlap each other by bonding a welding agent by heating, high temperature, high pressure, or the like.

As shown in fig. 5, the ends of the first extension portion 111 and the second extension portion 131 are overlapped in a staggered manner to form a connecting portion 200, and a first coupling member 170 is disposed between the first extension portion 111 and the second extension portion 131 at the connecting portion 200, and the ends of the first extension portion 111 and the second extension portion 131 are connected together by the first coupling member 170.

With continued reference to fig. 5, the valve holder 100 further includes a connecting member 150, and the connecting member 150 is sleeved on the ends of the first extending portion 111 and the second extending portion 131 to connect and fix the first extending portion 111 and the second extending portion 131. That is, the connecting part 200 of the first extending part 111 and the second extending part 131 is sleeved with the connecting member 150, so that the connection between the first extending part 111 and the second extending part 131 is more stable, and a greater and more stable radial supporting force can be provided for the valve stent 100. It is understood that the connecting member 150 may be a fastening member such as a sleeve, and the connecting member 150 may be in interference fit with the first extending portion 111 and the second extending portion 131 to enhance the stability of the connection, and may be specifically selected and arranged according to the actual use requirement, which is not limited herein.

Referring to fig. 6-7, fig. 6 is a schematic view of an axial view of another connection structure of the inner bracket and the outer bracket of the present application, and fig. 7 is a schematic cross-sectional view of another connection structure of the inner bracket and the outer bracket of the present application. In this embodiment, the ends of the first extension 111 and the second extension 131 are nested and form the connection part 200. Wherein, the end of one of the first extension 111 and the second extension 131 is provided with at least one groove, and the end of the other extension is provided to match with the groove. For example, the end of the first extension portion 111 is provided with at least one groove, and the end of the second extension portion 131 is embedded into the groove of the first extension portion 111 and is connected with the groove of the first extension portion 111 in a matching manner, so that the first extension portion 111 and the second extension portion 131 are connected and fixed. In other embodiments, at least one groove may be provided at an end of the second extension 131, and the end of the first extension 111 is embedded in the groove of the second extension 131 and is connected to the groove of the second extension 131 in a matching manner.

Specifically, as shown in fig. 6, the end of the first extension 111 may be regarded as a rivet having a certain width; the second extension 131 can be regarded as a connected piece (riveted piece) provided with a nail hole; the end surface area of the end of the first extension part 111 is larger than the end surface area of the end of the second extension part 131, the width of the rivet is larger than or equal to the inner diameter of the nail hole, so that the rivet is fixedly connected with the connected piece through the nail hole of the connected piece, that is, the end parts of the first extension part 111 and the second extension part 131 are connected and fixed like a riveting element, thereby forming the connecting part 200, being capable of providing an outward radial supporting force to the outer support 130, ensuring that the relative positions of the valve support 100 and the native heart tissue are kept unchanged, thereby assisting in enhancing the anchoring effect of the valve support 100 on the native heart tissue, and improving the fitting degree of the valve support 100 and the native heart tissue.

In this embodiment, the second extending portion 131 is connected to two opposite sides of the first extending portion 111, and the inner side of the second extending portion 131 is attached to two opposite sides of the first extending portion 111, so that the connection between the first extending portion 111 and the second extending portion 131 is more tight and more stable. Compared to the connection of the first extension 111 and the second extension 131 in the above-described embodiment, the connection of the first extension 111 and the second extension 131 in this embodiment can effectively reduce the volume of the sheath or the carrier that is loaded, thereby making it easier to deliver and implant the valve stent 100 in a minimally invasive manner (e.g., transapical, transventricular, transatrial, transseptal, etc.) in the atrium and/or ventricle.

Further, the connecting piece 150 is sleeved on the outer side of the connecting portion 200, so that the stability of the connecting portion 200 formed by overlapping the first extending portion 111 and the second extending portion 131 is improved, and a larger and more stable radial supporting force can be provided for the outer bracket 130. In addition, at the connection portion 200, second coupling members 190 are provided between opposite sides of the second extension portion 131 and the connection member 150, and cooperate to complete operations such as welding for fixedly connecting the connection member 150 and the connection portion 200.

Referring to fig. 1-2 and 8 in combination, fig. 8 is a schematic top view of an embodiment of a valve stent of the present application. Valve stent 100 includes an inner stent 110, with valve stent 100 being open to allow stent 110 to expand and valve stent 100 being closed to allow stent 110 to contract. As shown in fig. 8, the inner stent 110 is generally cylindrical, which may have a diameter of between 28 and 35 millimeters. Specifically, as shown in fig. 1 and 2, the inner bracket 110 includes a first extension 111, a flap portion 115, and a stabilizer portion 117.

Wherein, prosthetic leaflets are disposed within the inner stent 110, and are movable during blood flow. The flap portions 115 are used to sew the prosthetic leaflet into the region of the inner stent 110 where the prosthetic leaflet can be disposed, connecting the prosthetic leaflet to the inner stent 110. The stabilizers 117 can stabilize the structure of the inner stent 110 throughout the prosthetic leaflet after it is sewn within the inner stent 110.

Specifically, the number of prosthetic leaflets in the inner stent 110 can be 2, 3, etc., and is not particularly limited herein. When the number of the prosthetic leaflets is even, the prosthetic leaflets may be centrally symmetrically distributed along the circumferential direction of the inner surface of the inner stent 110; when the number of the prosthetic leaflets is odd, the prosthetic leaflets can be uniformly arranged along the circumferential direction of the inner surface of the inner stent 110 at equal intervals; two adjacent prosthetic leaflets join together near one end of the inner stent 110 to form a lobe angle. When the native heart tissue begins the contraction cycle, the prosthetic leaflets move in the same direction, depending on the direction of blood flow, and without damaging the prosthetic leaflets, the prosthetic leaflets create as large an opening as possible in the inner stent 110 to allow blood to flow from one chamber of the heart to another or to the exterior of the heart. When the contraction cycle of the native heart tissue is over, the blood will flow in the opposite direction, pushing the leaflets in the opposite direction to close the prosthetic leaflets, preventing retrograde blood flow through or blood backflow. That is, the prosthetic leaflets act as one-way valves in the inner stent 110, allowing blood to move in only one direction (e.g., from the left atrium to the left ventricle), and blocking regurgitation or reflux of blood.

Optionally, the inner stent 110 may further be provided with positioning holes for positioning and installing the prosthetic leaflets on the inner stent 110, so that the prosthetic leaflets supported by the valve stent 100 can help repair and/or replace the function of the defective native heart valve.

With continued reference to fig. 1-2 and 8, the valve stent 100 further includes an outer stent 130 fixedly connected to the inner stent 110, the outer stent 130 including a second extension 131, a body portion 132, a skirt structure 133, a transition bar 135, and an anchor assembly 137. A transition bar 135 connects the skirt structure 133 and the body portion 132; the anchor assembly 137 anchors the native annulus region such that the valve stent 100 is coupled to native heart tissue, thereby enabling the prosthetic leaflets to assist in repairing and/or replacing the function of a defective native heart valve.

As shown in fig. 1 and 2, the skirt structure 133 may be substantially flower-shaped as a whole, and is connected to the main body portion 132 through the transition rods 135, and the skirt structure 133 between two adjacent transition rods 135 may have various corrugated shapes. Specifically, as shown in fig. 1 and 2, the skirt structure 133 may be W-shaped, so that the skirt structure 133 may adapt to the physiological structure of the mitral valve or the tricuspid valve, that is, the outer stent 130 may better conform to the native valve annulus with a shape similar to the D-shape, and may form a D-shape or adapt to an anatomical structure more easily, so as to better conform to the real anatomical structure of the mitral valve, reduce the compression on the aorta, and prevent perivalvular leakage.

Optionally, the skirt structure 133 can be shaped specifically for a practical application, and is not limited specifically herein, in order to better conform to heart muscle tissue without increasing the resistance of the valve stent 100 to enter the sheath.

With continued reference to fig. 1-2, in this embodiment, the anchoring assembly 137 includes a plurality of barb structures disposed on the outer stent 130 and extending radially outward, so that the valve stent 100 penetrates into native heart tissue through the barb structures to anchor with the native annulus and the leaflet tissue, thereby fixing the valve stent 100 on the heart, improving the fit between the valve stent 100 and the heart, constraining the axial freedom of the valve stent 100 under the tensile force of the native valve, and effectively reducing the probability of the valve stent 100 shifting after implantation.

Wherein, the barb structure comprises at least two types, one type is a proximal barb 1371 which is close to the valve ring position, namely the barb structure which is close to the heart; the other is a distal barb 1373 near the leaflet location, i.e., a barb structure away from the heart; the proximal barb 1371 and the distal barb 1373 are opposite each other. Through setting up two-way barb structure, pierce into native valve ring with proximal end barb 1371 and pierce into native valve leaflet tissue with distal end barb 1373 for anchoring effect to native valve ring and valve leaflet tissue is more firm, effectively reduces valve support 100 and has appeared the probability of shifting for native heart tissue, has guaranteed actual operation's possibility. Alternatively, the proximal barbs 1371 and the distal barbs 1373 may be linear, curvilinear, or otherwise shaped, and are not particularly limited herein.

Referring to fig. 9-10, fig. 9 is a front view of another embodiment of the valve stent of the present application, and fig. 10 is an axial view of another embodiment of the valve stent of the present application. The outer stent 130 may further comprise auxiliary anchor assemblies 139, the auxiliary anchor assemblies 139 being located between any two transition bars 135 and connected to the skirt structure 133 to increase the outward radial support force, further enhance the anchoring effect of the valve stent 100 to the native heart tissue, promote the conformity of the valve stent 100 to the native heart tissue, and restore the defective native heart valve structure for a re-expansion movement.

In another embodiment, the present application further provides a prosthetic valve assembly. The prosthetic valve assembly includes the prosthetic valve and the valve stent 100 of the above-described embodiment, which are connected to each other.

Alternatively, the prosthetic valve may be a prosthetic leaflet, which is a thin layer of material, typically made of a homogenous or heterogeneous biological material, such as porcine pericardium, bovine pericardium, etc., or made of an artificial ultra high molecular weight polyethylene, nylon blend, polymer material, which is durable and does not suffer from tensile deformation or fatigue.

The number of prosthetic leaflets may be one, two or more, and the like, and is not particularly limited herein.

The valve stent 100 can support prosthetic leaflets, which can be considered as a frame structure that supports the prosthetic leaflets, by virtue of the anchoring attachment of the valve stent 100 to the native annulus region, such that the prosthetic leaflets supported by the valve stent 100 are relatively fixed with respect to the native heart tissue and more closely conform to the native heart tissue, such that the prosthetic leaflets can assist in repairing and/or replacing the function of a defective native heart valve.

Referring to fig. 11, fig. 11 is a schematic view of a prosthetic valve assembly of the present application implanted in a heart. In an embodiment, the valve stent 100 may be a mitral valve stent, may be delivered in a minimally invasive manner (e.g., transapical, transventricular, transatrial, transseptal, etc.) and implanted within the atrium and/or ventricle. When receiving the oppression effort that native heart tissue produced at the cardiac cycle, the similar Z style of calligraphy's connection structure in valve support 100 can provide a radial holding power and can balance the oppression power that valve support 100 received for valve support 100 can be along with native heart tissue synchronous motion, guarantees that the relative position of valve support 100 and native heart tissue keeps unchangeable, thereby supplementary reinforcing valve support 100 to the anchoring effect of native heart tissue, promotes the laminating degree of valve support 100 and native heart tissue, prevents the perivalvular leakage. In addition, the outer stent 130 uses a structural design with a larger opening area at the valve ring anchoring position, which can effectively reduce the functional damage of correspondingly limiting the systole and diastole caused by the compression of the outer stent 130 on the native valve ring, thereby increasing the implantation success rate of the prosthetic valve assembly.

In distinction to the prior art, the present application provides a valve stent and prosthetic valve assembly. The valve stent comprises an inner stent and an outer stent; the inner support comprises at least two first extending parts facing the outer support and forming a first angle with the inner support, the outer support comprises at least two second extending parts facing the inner support and forming a second angle with the outer support, each first extending part and each second extending part are correspondingly connected, and at least one of the first angle and the second angle is not a right angle; the connection and fixation of the inner support and the outer support are realized through the connection of the first extension part and the second extension part, and the first extension part and the second extension part form a Z-shaped connection structure through setting the angle formed by the first extension part and the inner support and the angle formed by the second extension part and the outer support, and the Z-shaped connection structure can give a radial supporting force to the outer support. When receiving the oppression effort that native heart tissue produced at the cardiac cycle, radial holding power can balance the oppression power that valve support received for valve support can be along with native heart tissue synchronous motion, guarantees that the relative position of valve support and native heart tissue keeps unchangeable, thereby supplementary reinforcing valve support to the anchoring effect of native heart tissue, promotes valve support and native heart tissue's laminating degree, prevents that the valve is leaked all around.

The above description is only for the purpose of illustrating embodiments of the present application and is not intended to limit the scope of the present application, and all modifications of equivalent structures and equivalent processes, which are made by the contents of the specification and the drawings of the present application or are directly or indirectly applied to other related technical fields, are also included in the scope of the present application.

Claims

1. A valve stent, comprising:

an inner stent and an outer stent connected to each other;

the inner support comprises at least two first extensions, the first extensions face the outer support and form a first angle with the inner support; the outer support comprises at least two second extending parts, the second extending parts face to the inner support and form a second angle with the outer support; each first extension part is correspondingly connected with the second extension part;

at least one of the first angle and the second angle is not a right angle.

2. The valve stent of claim 1,

the valve support further comprises a connecting piece, wherein the connecting piece is sleeved at the end parts of the first extending part and the second extending part and used for connecting and fixing the first extending part and the second extending part.

3. The valve stent of claim 1,

the first extension part and the second extension part are connected in any one or more combination of welding, flat pressing, tooth pressing and riveting.

4. The valve stent of claim 1,

the first angle is 30-60 degrees, and the second angle is 30-60 degrees.

5. The valve stent of claim 4,

the first angle is equal to the second angle.

6. The valve stent of claim 1,

the outer stent further comprises a main body part, a skirt edge structure, a transition rod piece and an anchoring assembly, wherein the transition rod piece is connected with the skirt edge structure and the main body part, the anchoring assembly comprises a plurality of barbs which are arranged on the outer stent and extend outwards in the radial direction, and the barbs are used for anchoring the valve stent on the heart.

7. The valve stent of claim 6,

the outer stent further comprises an auxiliary anchoring assembly, wherein the auxiliary anchoring assembly is connected with the skirt structure and positioned between any two transition rods and used for providing radial force for the outer stent.

8. The valve stent of claim 1,

the rigidity of the inner support is greater than the rigidity of the outer support.

9. The valve stent of claim 1,

the valve stent is a mitral valve stent or a tricuspid valve stent.

10. A prosthetic valve assembly, comprising an interconnected prosthetic valve and the valve stent of any one of claims 1-9.