Prosthetic heart valve

Abstract

The present application provides a kind of artificial heart valve, including metal support and the valve valve of being arranged in metal support, metal support includes support body, support body is completely covered by apron, to effectively improve the contact buffer between metal support and valve valve, reduce the probability of hemolysis, and accelerate the endothelialization process outside artificial heart valve, while enhancing the sealing performance inside support, reduce the risk of paravalvular leakage, another can reduce the damage of metal support when sheathing and releasing, enhance the fatigue resistance of metal support, improve the safety and reliability of operation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an interventional transcatheter artificial heart valve. Background Technology

[0002] In recent years, with the advancement of interventional treatment techniques, transcatheter artificial heart valve replacement or repair has rapidly developed and been applied clinically, achieving satisfactory results. This minimally invasive procedure involves implanting an artificial heart valve into the heart's native valve to replace or repair damaged natural valves.

[0003] refer to Figure 1 Interventional transcatheter artificial heart valves typically consist of a metal stent 1 and leaflets 2 housed within the stent. The procedure does not require open-chest surgery, resulting in minimal trauma and rapid recovery. It offers a new solution for patients with valvular stenosis whose lives cannot be prolonged or whose pain cannot be alleviated by conventional treatments. Interventional transcatheter artificial heart valves usually also include a skirt 3. The skirt 3 plays various roles in the practical application of artificial heart valves, including but not limited to providing a buffer between the leaflets 2 and the metal stent 1, assisting in inducing blood flow, promoting endothelialization of the valve tissue, and reducing the risk of hemolysis.

[0004] However, existing transcatheter artificial heart valves still face several challenges in application. For example, the skirt provides insufficient buffering between the leaflet and the metal stent; direct blood flow impacts the stent, increasing the risk of hemolysis; lateral endothelialization is slow; there is a risk of paravalvular leakage within the stent, reducing its seal; and the high friction between the stent and the sheath wall during insertion and release makes the stent susceptible to damage, affecting its fatigue resistance. Therefore, there is an urgent need to provide a novel artificial heart valve to address at least one of the technical problems of existing artificial heart valves. Summary of the Invention

[0005] The purpose of this invention is to provide an artificial heart valve that adopts a fully enclosed skirt design. By completely enclosing the stent body, the contact buffer between the metal stent and the valve can be effectively improved, the probability of hemolysis can be reduced, and the endothelialization process on the outside of the artificial heart valve can be accelerated. At the same time, the sealing performance inside the stent can be enhanced, and the damage to the metal stent during sheathing and release can be reduced, effectively enhancing the fatigue resistance of the metal stent.

[0006] To achieve at least one of the above objectives, the present invention provides an artificial heart valve, comprising a metal stent and a valve disposed within the metal stent, wherein the metal stent comprises a stent body and the stent body is completely enclosed by a skirt.

[0007] Optionally, the skirt is attached to the surface of the support body, and the skirt and the support body are connected to form a structure that cannot be separated from each other.

[0008] Optionally, the skirt includes an inner skirt and an outer skirt; the inner skirt covers the entire inner surface of the support body and is connected to the valve and the support body respectively; the outer skirt covers the entire outer surface of the support body and is connected to the support body; the inner skirt and the outer skirt are connected to each other to form a fully enclosed skirt.

[0009] Optionally, the skirt can be a one-piece molded structure or a split molded structure.

[0010] Optionally, the artificial heart valve has an inflow end and an outflow end; the outer skirt is connected to the inner skirt at the outflow end via a first connecting portion; the outer skirt is also connected to the inner skirt at the inflow end via a second connecting portion; the first connecting portion and the second connecting portion respectively cover the outflow end face and the inflow end face of the stent body.

[0011] Optionally, the metal bracket further includes a protruding structure disposed on the bracket body, the protruding structure extending at least partially beyond the outer surface of the bracket body, and the protruding structure being at least partially exposed outside the skirt.

[0012] Optionally, the protruding structure directly pierces the skirt hem, or the skirt hem has pre-drilled holes for the protruding structure to pass through.

[0013] Optionally, the protruding structure is used to penetrate a predetermined object, and / or the protruding structure is used for a detachable connection with a delivery device for an artificial heart valve.

[0014] Optionally, the metal support is a single-layer mesh support structure, or the metal support is a multi-layer mesh support structure.

[0015] Optionally, the thickness of the skirt does not exceed 0.2 mm.

[0016] Compared with the prior art, the present invention has the following technical effects:

[0017] The artificial heart valve provided by this invention includes a metal stent and a valve disposed within the metal stent. The metal stent includes a stent body, which is completely enclosed by a skirt. This configuration can more effectively provide contact buffering between the valve and the metal stent, reduce the probability of hemolysis, and allow for faster endothelialization of the artificial heart valve. Furthermore, the metal stent can rapidly form the desired thrombus, enhancing its sealing effect after implantation, reducing paravalvular leakage, and providing better hemodynamic performance. In particular, it can reduce plastic damage to the surface of the metal stent during implantation, ensuring its fatigue resistance, thereby improving the safety and reliability of the surgery.

[0018] In the artificial heart valve provided by this invention, the skirt is attached to the surface of the stent body, and the skirt and the stent body are connected to form an inseparable structure. This configuration can reduce the compression size of the artificial heart valve during delivery and reduce the difficulty of delivery. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the structure of an interventional transcatheter artificial heart valve;

[0020] Figure 2 A schematic diagram of the left ventricular structure used in the artificial heart valve provided in an embodiment of the present invention;

[0021] Figure 3 This is an application scenario diagram of the artificial heart valve placed at the native mitral valve annulus, as provided in an embodiment of the present invention;

[0022] Figure 4 and Figure 5 These are schematic diagrams of the artificial heart valve provided in the embodiments of the present invention from different perspectives.

[0023] [The annotations in the attached figures are explained below]:

[0024] 1-Metal stent; 2-Leaflet; 3-Skirt; 4-Left atrium; 5-Mitral valve annulus; 6-Left ventricle; 7-Mitral valve leaflet; 8-Papillary muscle; 9-Left ventricular outflow tract;

[0025] 10-Artificial heart valve; 101-Inflow end; 102-Outflow end; 11-Valve valve; 12-Skirt; 121-Inner skirt; 122-Outer skirt; 13-Connecting part; 131-First connecting part; 132-Second connecting part; 14-Connecting structure; 15-Anchoring structure. Detailed Implementation

[0026] The present invention will now be described in further detail. The invention will be described in more detail below with reference to the accompanying drawings, which illustrate preferred embodiments of the invention. It should be understood that those skilled in the art can modify the invention described herein while still achieving its advantageous effects. Therefore, the following description should be understood as being of general knowledge to those skilled in the art and is not intended to limit the invention.

[0027] For clarity, not all features of the actual embodiments are described. In the following description, well-known functions and structures are not detailed in detail, as they would obscure the invention with unnecessary detail. It should be understood that in the development of any actual embodiment, numerous implementation details must be made to achieve the developer's specific objectives, such as changes from one embodiment to another according to limitations related to the system or business. Furthermore, it should be understood that such development work may be complex and time-consuming, but is merely routine work for those skilled in the art.

[0028] To make the objectives and features of the present invention more apparent and understandable, the specific embodiments of the present invention will be further described below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise ratios, and are only used to facilitate and clarify the illustration of the embodiments of the present invention. In this document, the term "or" is generally used to include the meaning of "and / or" unless otherwise expressly indicated.

[0029] As used in this specification, the terms "inflow end" and "outflow end" refer to the direction in which blood flows through the valve prosthesis. While "inflow end" and "outflow end" are not restrictive, "inflow end" generally refers to the end near where blood flows into the artificial heart valve, and "outflow end" generally refers to the end near where blood flows out of the artificial heart valve. As used in this specification, the singular forms "a," "an," and "the" include the plural objects unless otherwise expressly stated. As used in this specification, the term "or" generally means "and / or" unless otherwise expressly stated. Furthermore, "inner" or "internal" or "medial" refers to the side of the stent closer to the human tissue, while "outer" or "external" or "lateral" refers to the side of the stent closer to the human tissue. It should also be noted that, unless specifically stated or indicated, the terms "first" and "second" in this specification are used only to distinguish individual components, elements, steps, etc., and are not used to indicate logical or sequential relationships between individual components, elements, steps, etc.

[0030] Figure 2 This diagram illustrates the structural schematic of the left ventricular structure used in the artificial heart valve provided in an embodiment of the present invention. Figure 2As shown, the left ventricular structure consists of the left atrium 4, the left ventricle 6, the mitral valve annulus 5 at the junction of the left atrium 4 and the left ventricle 6, the mitral valve leaflets 7 attached to it, and the papillary muscles 8 and their chordae tendineae located within the left ventricle 6. A healthy heart pumps blood from the left atrium 4 into the left ventricle 6, and the mitral valve leaflets 7 ensure unidirectional blood flow, ultimately draining out through the left ventricular outflow tract 9. Due to mitral valve disease, the mitral valve leaflets 7 cannot completely guarantee unidirectional blood flow within the heart, leading to mitral regurgitation.

[0031] However, it should be understood that the artificial heart valve of the present invention can be applied not only to the mitral valve, but also to the tricuspid valve, aortic valve, or pulmonary valve. In the following description, the artificial heart valve provided by the present invention is illustrated using the mitral valve as an example, but should not be construed as limiting the present invention.

[0032] Figure 3 This diagram illustrates an application scenario where the artificial heart valve 10 provided in this embodiment of the invention is placed at the native mitral valve annulus 5. Figure 3 As shown, in this embodiment, the artificial heart valve 10 is implanted into the heart via a catheter and ultimately anchored to the mitral valve annulus 5. The artificial heart valve 10 replaces the mitral valve leaflet 7 to ensure unidirectional blood flow, thereby curing mitral regurgitation. The artificial heart valve 10 has two forms: an expanded form during normal operation and a compressed form when inserted into the sheath, allowing the artificial heart valve 10 to switch between compressed and expanded states.

[0033] Figure 4 and Figure 5 The diagrams show the structure of the artificial heart valve 10 provided in the embodiments of the present invention from different perspectives. Figure 4 and Figure 5 As shown, the artificial heart valve 10 includes a metal stent that provides primary support strength for the valve (the main body of the metal stent is not visible in the figure because it is encased in a biomaterial); a valve valve 11 (i.e., an artificial leaflet valve); and a skirt 12 that provides connection between the metal stent and the valve valve 11. The valve valve 11 is disposed inside the metal stent and is typically connected to the stent body of the metal stent via the skirt 12. Typically, after connecting the skirt 12 to the valve valve 11, the skirt 13 is then connected to the stent body.

[0034] This invention does not limit the structure of the metal support; it can be implemented using existing structures. The metal support in this embodiment includes a support body.

[0035] Valve 11 consists of at least two leaflets; in this embodiment, the number of leaflets is three. Valve 11 is made of animal pericardium or other biocompatible polymer material. One end of valve 11 is directly and stably connected to skirt 12, and the other end of valve 11 is a free end. The connecting end of valve 11 protrudes sinus-shaped towards the inflow end 101 (e.g., Figure 5 (As indicated by the lead line labeled a), the free end of valve 11 corresponds to the valve outflow end 102, such that the entire at least two valve leaflets are bowl-shaped. In operation, valve 11 replaces the original valve to open and close the blood passage, enabling unidirectional blood flow.

[0036] The skirt 12 is a thin film attached to the inner and outer surfaces of the stent, serving functions such as preventing paravalvular leakage, reducing friction, promoting endothelialization, and reducing hemolysis. Specifically, the stent body of the metal stent is completely enclosed by the skirt 12. "Completely enclosed" means the stent body is entirely covered by the skirt 12. The stent body is typically a hollow tubular structure, enclosed by the skirt 12 from the inside out or from the outside in, including the end faces of the stent body. However, "completely enclosed" should not be narrowly interpreted as a completely sealed state. In special cases, to ensure the function of the metal stent, functional structures on the stent need to be exposed outside the skirt 12. The fully enclosed skirt 12 acts like a thin protective sheath, completely separating the leaflets from the stent body, and also completely isolating the stent body from the blood flow environment.

[0037] This configuration effectively separates the valve 11 from the stent by using the skirt 12 covering the inner surface of the stent body. This significantly reduces the likelihood of fatigue failure caused by the valve 11 colliding with the stent body during long-term reciprocating motion. It also effectively reduces the risk of metal ions precipitating from the stent body onto the valve 11 surface, leading to valve 11 calcification. Furthermore, with the entire inner surface of the stent body covered by the skirt 12, even if the leaflets undergo creep and lengthen after long-term implantation, the skirt 12 can still effectively prevent collisions between the leaflets and the stent body during the opening and closing motion of the cardiac cycle, providing better cushioning and protection. Simultaneously, the skirt 12 covering the outer surface of the stent body not only prevents the metal stent body from being directly exposed to the blood environment, thus avoiding direct contact between the metal stent and the endothelium at the implantation site, but also more effectively promotes the endothelialization process on the outer side of the valve. Furthermore, the skirt 12, which fully encloses the stent body, avoids direct impact of blood flow on the metal stent, reducing the probability of hemolysis, enhancing the internal sealing of the stent body, lowering the risk of paravalvular leakage, and providing better hemodynamic performance after implantation. In particular, the outer skirt 12 can provide friction buffer between the metal stent body and the inner wall of the sheath during sheath retraction and release, reducing plastic damage to the surface of the metal stent body during implantation, thus ensuring its fatigue resistance and effectively improving the safety and reliability of the surgery.

[0038] In one specific embodiment, the skirt 12 includes an inner skirt 121 and an outer skirt 122. The inner skirt 121 covers the entire inner surface of the metal support body and is directly connected to one end of the valve 11, and is also connected to the support body. The inner skirt 121 can be fixed to the support body by one or more combinations of sewing, bonding, welding, or other methods. Preferably, the inner skirt 121 is tightly fitted to the inner surface of the support body, that is, the inner skirt 121 and the support body are connected to form an inseparable structure. The connection between the inner skirt 121 and the valve 11 can also be fixed by one or more combinations of sewing, bonding, welding, or other methods. Meanwhile, the outer skirt 122 covers the entire outer surface of the support body and is connected to the support body. The outer skirt 122 can also be fixed to the support body by one or more combinations of sewing, bonding, welding, or other methods. Preferably, the outer skirt 122 is tightly fitted to the outer surface of the support body, that is, the outer skirt 122 and the support body form an inseparable structure. Further, the inner skirt 121 and the outer skirt 122 are interconnected to form a fully enclosed skirt 12. It should be understood that the outer surface of the support body refers to the exposed surface, including the outer peripheral surface and end face of the support body; the inner surface of the support body refers to the surface located inside the support body, specifically including the inner peripheral surface of the support body.

[0039] In a preferred embodiment, the entire skirt 12 needs to be fitted to the surface of the stent body, and the skirt 12 and the stent body are connected to form an inseparable structure, so that the compression size of the entire artificial heart valve 10 is smaller when it is passed through the catheter, reducing the difficulty of implantation and delivery. Preferably, the thickness of the skirt 12 does not exceed 0.2 mm, which can reduce the compression size of the entire artificial heart valve 10 when it is passed through the catheter.

[0040] Given the requirements for the sealing, ductility, and tensile strength of the skirt 12, and provided that it meets the requirements for medical implantation, the preferred material for the skirt 12 is one or a combination of polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), or other polymeric materials that can meet the requirements.

[0041] It should be understood that in the artificial heart valve 10 provided by the present invention, the metal stent can be a single-layer mesh stent structure or a multi-layer mesh stent structure. The multi-layer mesh stent structure includes, but is not limited to, two layers. The multi-layer mesh stent structure provides better support, is less prone to displacement, and the multiple stents can have different strengths. The outer stent is used to limit the implantation position, while the inner stent is used to ensure the valve's hydrodynamic performance. The two stents do not interfere with each other, and the deformation of the inner stent after implantation will not affect its shape or performance. The outer stent is positioned outside and surrounds the inner stent, and the inner and outer stents are connected and can move relative to each other.

[0042] This invention is particularly suitable for solving the problems associated with multilayer stents. By completely encapsulating the multilayer stent, it can effectively reduce the contact pressure damage that the complexity of the multilayer stent structure may cause to the biomaterial leaflets during the compression of the artificial heart valve, while also achieving the advantages mentioned above. It should be understood that when the metal stent is a multilayer mesh structure, taking a double-layer stent as an example, the inner skirt 121 covers the inner surface of the inner stent, and the outer skirt 122 wraps around the outer surface of the outer stent.

[0043] In some embodiments, the skirt 13 is a one-piece structure, such as a three-dimensional one-piece molding, which provides better sealing. For example, the inner skirt 121 extends from the inner side of the support body to the outer side of the support body to form the outer skirt 122, or the outer skirt 122 extends from the outer side of the support body to the inner side of the support body to form the inner skirt 121.

[0044] In other embodiments, the skirt 13 is a split-molded structure, meaning that the inner skirt 121 and the outer skirt 122 are independently arranged and fixedly connected. For example, the outer skirt 122 and the inner skirt 121 are connected by a connecting part 13.

[0045] The artificial heart valve 10 has an inflow end 101 and an outflow end 102. As an example, the outflow end 102 corresponds to one end of the ventricle, and the inflow end 101 corresponds to one end of the atrium.

[0046] In one specific embodiment, the connecting portion 13 includes a first connecting portion 131 and a second connecting portion 132; the outer skirt 122 is connected to the inner skirt 121 at the outflow end 102 of the artificial heart valve via the first connecting portion 131, such as by suturing, adhesion, welding, or one or more combinations thereof; the outer skirt 122 is also connected to the inner skirt 121 at the inflow end 101 of the artificial heart valve via the second connecting portion 132, such as by suturing, adhesion, welding, or one or more combinations thereof. In implementation, the first connecting portion 131 and the second connecting portion 132 respectively cover the outflow end face and the inflow end face of the stent body, both of which are outer surfaces. To reduce implementation difficulty, the skirt 12 is preferably a split-molded structure.

[0047] When the skirt 12 is a split molding structure, the skirt 12 can be composed of different materials. For example, the outer skirt 122 needs better inner skinning ability, so it needs a larger surface roughness. Therefore, the material of the outer skirt 122 is preferably polyethylene terephthalate (PET). The first connecting part 131 corresponding to the outlet end 102 does not have high requirements for ductility but has high requirements for sealing performance. Therefore, the material of the first connecting part 131 is preferably selected from one or a combination of polytetrafluoroethylene (PTFE) and expanded polytetrafluoroethylene (e-PTFE).

[0048] Both the skirt 12 and the connecting portion 13 are made of polymer or treated biological tissue. This invention does not limit the specific materials used to manufacture the skirt 12 and the connecting portion 13. It should be understood that the materials for the skirt 12 and the connecting portion 13 include, but are not limited to, the polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and expanded polytetrafluoroethylene (e-PTFE) listed above. As those skilled in the art will understand, in other embodiments, the materials for the skirt 12 and the connecting portion 13 may also be other polymers. The skirt 12 and / or the connecting portion 13 may be made of one material or a combination of multiple materials.

[0049] Typically, metal stents have protruding structures on their body, such as protruding structures that connect to the delivery device of an artificial heart valve, and / or protruding structures that penetrate into the myocardium, blood vessels, or other predetermined objects, or protruding structures that perform other functions. This application does not limit the specific types of protruding structures. In order not to affect the original function of the metal stent, the protruding structures are at least partially exposed on the outside of the skirt 12.

[0050] For example, in one exemplary embodiment, the artificial heart valve 10 of the present invention needs to be compressed and sheathed before being implanted at a predetermined site during surgery. This action typically requires the connecting structure 14 on the metal stent to work with the delivery device of the artificial heart valve to perform functions such as connection, fixation, stretching, and disengagement. Here, the connecting structure 14 is a protruding structure. The connecting structure 14 is located at the outflow end of the stent body and is used for a separable connection with the delivery device of the artificial heart valve. To ensure that the function of the connecting structure 14 is not affected, the connecting structure 14 is at least partially exposed outside the skirt 12, allowing the connecting structure 14 to extend out of the skirt 12 and connect normally with the delivery device. The present invention does not require a specific structure for the connecting structure 14, which can be of various forms, such as the form of a connecting hole.

[0051] In this embodiment of the invention, the connecting structure 14 extends beyond the skirt 12 and has a connecting hole. Generally, there are multiple connecting structures 14 distributed circumferentially along the support body. All connecting structures 14 extend beyond the skirt 12. In specific implementations, the connecting structure 14 can directly pierce the skirt 12, or the skirt 12 may have holes for the connecting structure 14 to pass through.

[0052] For example, in another exemplary embodiment, the protruding structure is an anchoring structure 15, which is disposed on the stent body to enhance the fixation of the artificial heart valve at the valve annulus. In this case, the anchoring structure 15 extends at least partially beyond the outer surface of the stent body to allow it to penetrate human tissue for anchoring. To avoid affecting the puncture and fixation capabilities of the anchoring structure 15, it is at least partially exposed outside the skirt 12. This invention does not specify the specific type of anchoring structure 15; it can be various forms of fixation, such as barbs, hooks, anchor pins, etc. This application does not limit the specific location of the anchoring structure 15 on the stent body.

[0053] In this embodiment of the invention, the anchoring structure 15 extends entirely from the outer surface of the support body and passes through the outer skirt 122. There are generally multiple anchoring structures 15, which are separately arranged on the support body. All anchoring structures 15 extend beyond the outer skirt 122. In specific implementations, the anchoring structure 15 can directly pierce the outer skirt 122, or the outer skirt 122 may have pre-drilled holes for the anchoring structure 15 to pass through.

[0054] It should be understood that the protruding structure may protrude or pierce through the inner skirt 121, or it may protrude or pierce through the first connecting portion 131 or the second connecting portion 132, or other possible locations to achieve the intended function, and it is not necessarily required to protrude or pierce through the outer skirt 122. Furthermore, the size of the holes on the skirt 12 for the protruding structure to pass through is generally just large enough to allow the protruding structure to pass through, in order to ensure sealing performance.

[0055] In summary, the artificial heart valve provided by this invention, by completely wrapping the metal stent body with a skirt, effectively provides contact buffering between the valve and the stent body, reduces the probability of hemolysis, and allows the outer skirt to accelerate the endothelialization of the artificial heart valve. Meanwhile, the stent encased by the inner skirt can quickly form the expected thrombus, enhancing its sealing effect after implantation, reducing paravalvular leakage, providing better hemodynamic performance, and reducing plastic damage to the surface of the metal stent during implantation to ensure its fatigue resistance and improve the safety and reliability of the surgery.

[0056] It should be understood that the above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any form or substance. Furthermore, although the innovation of the present invention originates from the field of mitral valve technology, those skilled in the art will understand that the artificial heart valve of the present invention can also be applied to the replacement of tricuspid, aortic, or pulmonary valves. It should also be understood that the skirt in the present invention, while fully enclosing the stent body of the metal stent, does not affect the original function of the metal stent, such as sheathing, release, anchoring, or other functions. Therefore, functional structures on the metal stent, including but not limited to protruding structures and connecting structures, are exposed on the outside of the skirt.

[0057] It is understood that although the present invention has been disclosed above with reference to preferred embodiments, these embodiments are not intended to limit the present invention. For any person skilled in the art, many possible variations and modifications can be made to the technical solutions of the present invention based on the disclosed technical content, or equivalent embodiments can be modified accordingly, without departing from the scope of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the present invention shall still fall within the protection scope of the present invention.

Claims

1. An artificial heart valve, comprising a metal stent and a valve disposed within the metal stent, characterized in that, The metal support includes a support body completely wrapped by a skirt; the skirt adheres to the surface of the support body and the skirt and the support body are connected to form an inseparable structure; the metal support is a multi-layer mesh support structure, in which the outer support layer is disposed outside the inner support layer and surrounds the inner support layer, the inner support layer is connected to the outer support layer and can move relative to it; the thickness of the skirt does not exceed 0.2mm; the support body is provided with a protruding structure, the protruding structure piercing the skirt or the skirt having holes for the protruding structure to pierce; The skirt includes an inner skirt and an outer skirt; the inner skirt covers the inner surface of the inner support; the outer skirt covers the outer surface of the outer support; the inner skirt and the outer skirt are connected to each other to form a fully enclosed and separately formed skirt; The outer skirt is connected to the inner skirt at the outflow end of the artificial heart valve via a first connecting portion; the outer skirt is connected to the inner skirt at the inflow end of the artificial heart valve via a second connecting portion; the first connecting portion and the second connecting portion respectively cover the end face of the outflow end and the end face of the inflow end of the stent body; the material of the outer skirt is polyethylene terephthalate; the material of the first connecting portion is selected from one or a combination of polytetrafluoroethylene, expanded polytetrafluoroethylene, etc. The protruding structure includes a connecting structure and an anchoring structure; the connecting structure is disposed at the outflow end of the support body and is used for a separable connection with the conveying device; the anchoring structure extends from the outer surface of the support body and passes through the outer skirt.

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