Heart valve stents and artificial heart valves

Abstract

The present disclosure belongs to the technical field of medical devices, and provides an (artificial / implantable type) heart valve stent and an artificial heart valve. The heart valve stent includes a support unit and a protruding and extending branch structure. A flow passage through which blood flows is defined in the support unit. The protruding and extending branch structure extends from the support unit to the outside of the flow passage. A protruding and extending portion capable of abutting against heart tissue is formed on the protruding and extending branch structure. A gap for accommodating the native valve leaflet of the heart is formed between the protruding and extending branch structure and the support body. According to the technical solution of the present disclosure, the stability and reliability of the installation and fixation of the heart valve stent can be improved, the service life of the heart valve stent can be extended, the risk of re-replacing the patient's valve can be reduced, and the stenosis of the coronary artery can be alleviated after the heart valve stent is used in the patient.

Description

Technical Field

[0001] This disclosure belongs to the technical field of medical devices, and specifically relates to heart valve stents and artificial heart valves.

[0002] (Cross-reference to Related Applications) This disclosure claims priority based on a Chinese application filed with the Chinese Patent Office on July 12, 2022, with application number CN202210820044.3 and title "Implantable Heart Valve Stent and Artificial Heart Valve", a Chinese application filed with the Chinese Patent Office on July 12, 2022, with application number CN202210820049.6 and title "Heart Valve Stent and Artificial Heart Valve", a Chinese application filed with the Chinese Patent Office on July 12, 2022, with application number CN202210822410.9 and title "Artificial Heart Valve Stent and Artificial Heart Valve", and a Chinese application filed with the Chinese Patent Office on March 3, 2023, with application number CN2023102038996 and title "Heart Valve Stent and Artificial Heart Valve", and all of its content is incorporated herein by reference.

Background Art

[0003] The heart valves are located between the atria and ventricles, and between the ventricles and the aorta, and function as one-way valves for the one-way flow of blood. The four valves in the human body are called the mitral valve, tricuspid valve, aortic valve, and pulmonary valve, respectively. When these valves are diseased (e.g., stenosed or insufficient), they affect blood flow, lead to abnormal heart function, and ultimately result in heart failure.

[0004] Currently, when there is a valve disease, treatment is often carried out using valve replacement surgery, that is, replacing it with an artificial mechanical valve or a biological valve. However, conventional heart valve stents are prone to coming off due to the influence of blood flow after implantation, and the stability of attachment and fixation is relatively poor, which impairs the service life of artificial heart valves, increases the risk of re-replacement of the patient's valves, and after some heart valve stents are attached, coronary artery occlusion is likely to occur.

Summary of the Invention

[0005] This disclosure provides a cardiac valve stent. The cardiac valve stent comprises a support body and at least one protruding extension branch structure connected to the support body, wherein a flow passage for blood is defined in the support body, the protruding extension branch structure extends outward from the support body outward from the flow passage, the protruding extension branch structure has a protruding extension portion that can contact cardiac tissue, and a gap is formed between the protruding extension branch structure and the support body for accommodating the cardiac valve leaflets.

[0006] Optionally, the support body includes a plurality of support units, and the flow passage is defined and formed by the plurality of support units. Each of the support units includes two first support structures for connecting to different valve leaflets, and a second support structure connected to the two first support structures, with a space formed between the two first support structures and the second support structure that can be covered by connecting a cover member.

[0007] This disclosure further provides another type of heart valve stent, the heart valve stent being made of at least one elongated material woven into a defined shape, the heart valve stent having a defined flow passage for blood flow, and at least one of the elongated material extending outward from the flow passage to form a protruding extension that can contact cardiac tissue.

[0008] Optionally, the heart valve stent includes a plurality of support units, and the flow passage is defined and formed by the plurality of support units. Each of the support units includes two first support structures for connecting to different valve leaflets, and a second support structure connected to the two first support structures, with a space formed between the two first support structures and the second support structure that can be covered by connecting a cover member.

[0009] Optionally, if upstream and downstream directions are defined along the direction in which blood flows through the flow passage, the second support structure is located upstream of the two first support structures.

[0010] Optionally, the two first support structures extend downstream from both ends of the second support structure, and the two first support structures are joined and connected.

[0011] Optionally, the two first support structures extend downstream from both ends of the second support structure, and the second ends of the two first support structures are connected to each other.

[0012] Optionally, each of the support units is connected to the protruding extension branch structure, and the protruding extension branch structure is located between two adjacent support units in the circumferential direction of the support body.

[0013] Optionally, each support unit is connected to two of the protruding extension branch structures, and two of the protruding extension branch structures between two adjacent support units are connected to each other.

[0014] Optionally, the two protruding extension branch structures between two adjacent support units are formed from a single braided wire.

[0015] Optionally, a connecting ring is formed on the downstream portion of the first support structure.

[0016] Optionally, the connecting ring is formed on each of the first support structures.

[0017] Optionally, a first rivet knot structure is provided upstream of the connecting ring, and the connecting ring is formed as a closed ring by the first rivet knot structure.

[0018] Optionally, each support unit and its adjacent support unit are connected by a rivet structure to form a second rivet-connected structure, in which the first support structure and the second support structure of two adjacent support units are arranged in parallel, and the gap for accommodating the heart's own valve leaflets is formed between the protruding extension branch structure and the first support structure and the second support structure in the second rivet-connected structure.

[0019] Optionally, the two first support structures of each support unit are connected by a rivet structure to form a third rivet connection structure.

[0020] Optionally, along the direction in which blood flows through the flow passage, the protruding extension branch structure includes a continuous protruding extension segment and a connecting segment. The protruding extension segment is bent and extended in a direction away from the flow passage, and the connecting segment is connected at one end to the protruding extension segment and at the other end to the supporting body, with the angle formed between the protruding extension segment and the axial direction of the flow passage being 1° to 150°.

[0021] Optionally, the horizontal distance a between the end of the connecting segment that connects to the protruding extension segment and the support body located upstream of the flow passage is 1 mm to 20 mm.

[0022] Optionally, the heart valve stent is made by weaving together at least one elongated piece of material.

[0023] Optionally, each support unit further includes a third support structure, the third support structure forming a connecting ring located downstream of the heart valve stent.

[0024] Optionally, the third support structure has one end connected to the first support structure and the other end forming the protruding extension.

[0025] Optionally, each of the support units has two of the third support structures. One end of each of the two third support structures is connected to each of the two first support structures, and the other ends of the two third support structures respectively form the protruding extensions.

[0026] Optionally, one connection ring is respectively formed at the most downstream position of each of the third support structures.

[0027] Optionally, the protruding extension of each support unit and the protruding extension of the adjacent support unit are formed by bending the same elongated material, and the two adjacent protruding extensions are continuously formed.

[0028] Optionally, each support unit and the adjacent support unit are connected by a rivet structure to form a first rivet connection structure. In the first rivet connection structure, each elongated material is arranged in parallel, and the two protruding extensions are located in the middle.

[0029] Optionally, the two first support structures of each support unit are connected by a rivet structure to form a second rivet connection structure, and the third support structure is also connected to the second rivet connection structure.

[0030] Optionally, the angle formed between the protruding extension direction of the protruding extension and the direction perpendicular to the axial direction of the flow passage is 15° to 90°.

[0031] Optionally, along the direction in which blood flows through the flow passage, the third support structure includes continuous protruding extension segments, transition segments, and connection segments. The protruding extension segment forms the protruding extension. One end of the transition segment is connected to the protruding extension segment, and the other end bends and extends in a direction away from the flow passage. The angle formed between the transition segment and the direction perpendicular to the axial direction of the flow passage is 60° to 150°. One end of the connection segment is connected to the transition segment, and the other end is connected to the first support structure.

[0032] Optionally, the elongated material may include a shape memory alloy wire.

[0033] Optionally, the second support structure may be made by weaving together diameter-changing shape memory alloy wires, or A shape memory alloy tube is fitted around a portion of the outer circumference of the second support structure.

[0034] This disclosure further provides implantable cardiac valve stents.

[0035] The implantable heart valve stent includes a plurality of support units, and the plurality of support units define and form a flow passage through which blood flows. At least one of the support units includes a protruding extension branch structure, the protruding extension branch structure extending in a direction away from the flow passage to form a protruding extension portion that can contact cardiac tissue, and the protruding extension branch structure extending in an upstream direction of the flow passage to form a connecting structure that can connect to a cover member.

[0036] Optionally, each support unit includes two first support structures for connecting to different valve leaflets, and a first space is formed between the two first support structures and the connecting structure, which can be covered by connecting a cover member.

[0037] Optionally, if upstream and downstream directions are defined along the direction in which blood flows through the flow passage, the connecting structure is located upstream of the two first support structures.

[0038] Optionally, the connection structure includes at least one subconnection structure, the at least one of which is installed overlapping with or at a distance from the connection structure.

[0039] Optionally, the two first support structures extend downstream from both ends of the connecting structure, and the two first support structures are joined and connected.

[0040] Optionally, each of the support units includes the protruding extension branch structure, and the protruding extension branch structure is located between two adjacent support units in the circumferential direction of the flow passage.

[0041] Optionally, each support unit includes two of the protruding extension branch structures, and the connecting structures formed by the two protruding extension branch structures are connected to each other.

[0042] Optionally, a second space for passing medical equipment is formed between each of the aforementioned protruding extension branch structures and the first support structure.

[0043] Optionally, the protruding extension branch structure and the first support structure are made by braiding together a single braided wire.

[0044] Optionally, the protruding extension branch structure has a connecting ring formed at the end located downstream of the flow passage.

[0045] Optionally, each support unit and its adjacent support unit are connected by a rivet structure to form a first rivet-connected structure, and in the first rivet-connected structure, the first support structures and connecting structures of two adjacent support units are arranged in parallel.

[0046] Optionally, the two first support structures of each support unit are connected by a rivet structure to form a second rivet connection structure.

[0047] Optionally, the protruding extension branch structure includes a first connecting segment, a contact segment, and a second connecting segment, which are connected in order, wherein the first connecting segment is connected to the first riveted structure, the contact segment has its first end connected to the first connecting segment and its second end protruding and extending away from the flow passage, and the second connecting segment has one end connected to the second end of the contact segment and the other end connected to the first support structure.

[0048] Optionally, the angle α between the contact segment and the axial direction of the flow passage is between 10° and 150°.

[0049] Optionally, the distance b between the second end of the contact segment and the first connecting segment is 1 mm to 20 mm.

[0050] Optionally, the implantable heart valve stent is constructed by braiding at least one braided wire.

[0051] Optionally, the braided wire may include a shape memory alloy wire.

[0052] Optionally, the connection structure may be made by braiding a diameter-changing shape memory alloy wire, or A shape memory alloy tube is fitted around a portion of the outer circumference of the aforementioned connecting structure.

[0053] This disclosure further provides an artificial cardiac valve. The artificial cardiac valve comprises a cardiac valve stent based on any one of the above or an implantable cardiac valve stent based on any one of the above, A valve leaflet provided within the flow passage and connected to the first support structure of the cardiac valve stent or the implantable cardiac valve stent, The system includes a first sealing cover member which is installed in and connected to the space formed between the two first support structures and the second support structure of the cardiac valve stent or implantable cardiac valve stent, thereby covering the space.

[0054] Optionally, the system further includes a second sealing cover member that is positioned to surround the outer circumference of the heart valve stent or the implantable heart valve stent.

[0055] Optionally, the second sealing cover member is disc-shaped, and its outer peripheral edge is bent downstream of the heart valve stent to form a protruding edge.

[0056] Optionally, the material of the valve leaflet is at least one of polymer materials, biomaterials, and tissue engineering materials.

[0057] Optionally, the method of connecting the valve leaflet to the first support structure of the cardiac valve stent or the implantable cardiac valve stent is one of the following: sewing with sutures, adhesive bonding, hot melt bonding, or polymer bonding.

[0058] This disclosure provides another type of cardiac valve stent. The cardiac valve stent includes a support body and at least one protruding extension branch structure. The support body includes a plurality of support units, which define and form a passage through which blood flows, each of which includes two first support structures for connecting to different valve leaflets, and at least one of the support units includes a second support structure, the second support structure being provided on the side of the first support structure closer to its adjacent support unit. The protruding and extending branch structure is fixed relative to two adjacent support units and extends outward from the support body to the passage, forming a gap between the protruding and extending branch structure and the support body for accommodating the heart's own valve leaflets.

[0059] Optionally, each support unit includes two of the second support structures, with the two second support structures in each support unit being located on either side of the two first support structures.

[0060] Optionally, each support unit includes a third support structure connected to two of the first support structures, and a space is formed between the two first support structures and the third support structure that is covered by the connection of a first cover member.

[0061] Optionally, each of the first support structures is fixed relative to one of the protruding extension branch structures, and each of the protruding extension branch structures is fixedly connected relative to two adjacent first support structures belonging to each of two adjacent support units, with the intermediate portion of the protruding extension branch structure forming a protruding extension for contact with cardiac tissue.

[0062] Optionally, two adjacent second support structures belonging to each of two adjacent support units are located between projecting extension branch structures that connect to these two support units along the circumferential direction of the heart valve stent.

[0063] Optionally, two adjacent second support structures belonging to each of two adjacent support units are located inside the protruding extension branch structure that connects to these two support units along the radial direction of the heart valve stent.

[0064] Optionally, the downstream portions of the two first support structures of the support unit and the downstream portions of the two protruding extension branch structures are connected by a rivet structure to form a first rivet connection structure, and these two protruding extension branch structures are two protruding extension branch structures that are fixed relative to these two first support structures.

[0065] Optionally, each of the second support structures is fixed relative to one of the protruding extension branch structures, the intermediate portion of which forms a protruding extension for contact with cardiac tissue.

[0066] Optionally, portions of two adjacent second support structures belonging to each of two adjacent support units are located along the circumferential direction of the heart valve stent, between the protruding extension branch structures that connect to these two support units.

[0067] Optionally, portions of two adjacent second support structures belonging to each of two adjacent support units are located inside the protruding extension branch structure that connects to these two support units along the radial direction of the heart valve stent.

[0068] Optionally, the downstream portions of the two first support structures of the support unit are connected by a rivet structure to form a first rivet-connected structure, and the downstream portion of the protruding extension branch structure and the second support structure are connected by a rivet structure to form a second rivet-connected structure.

[0069] Optionally, the upstream portions of two adjacent first support structures belonging to each of two adjacent support units, the upstream portions of two adjacent second support structures, and the downstream portions of two adjacent third support structures are connected by a rivet structure to form a third rivet connection structure.

[0070] Optionally, each support unit may be formed by braiding one braided wire, and each protruding extension branch structure may be formed by another braided wire.

[0071] Optionally, the braided wire includes a diameter change portion, the diameter of which is larger than the diameter of the other portion, and the diameter change portion is provided in correspondence with the rivet structure.

[0072] Optionally, the braided wire may be made from a diameter-changing shape memory alloy wire, thereby forming the diameter-changing portion, or A shape memory alloy tube is fitted around the outer circumference of the braided wire, and the portion fitted with the shape memory alloy tube is the diameter change portion.

[0073] Optionally, a connecting ring is formed downstream of each of the support units.

[0074] This disclosure further provides an artificial cardiac valve, the artificial cardiac valve comprising a cardiac valve stent according to any one of the above, a valve leaflet provided in the passage and connected to a first support structure of the cardiac valve stent, and a first cover member configured to cover by connection a space formed between two first support structures and a third support structure of the support unit of the cardiac valve stent.

[0075] Optionally, the artificial heart valve further includes a second cover member, the second cover member being positioned to surround the outer circumference of the heart valve stent, the upstream end of the second cover member being connected to the first cover member, and the circumference of the second cover member gradually increasing and then gradually decreasing from the upstream end to the downstream end.

[0076] Optionally, an annular first projection is formed at the downstream end of the second cover member, and the first projection is formed toward the downstream of the heart valve stent.

[0077] Optionally, the first protruding edge and the second cover member are provided with a housing notch, configured to accommodate the support body.

[0078] Optionally, an annular second projection is formed on the outer peripheral edge of the second cover member, and the second projection is formed toward the downstream of the heart valve stent.

[0079] Optionally, the second projection is provided on the outermost edge of the second cover member, where the circumference is greatest.

[0080] To more clearly illustrate the technical concepts of the embodiments of this disclosure, the drawings used in the embodiments of this disclosure are briefly described below. The drawings described are merely illustrative of some embodiments of this disclosure and do not limit its scope. Those skilled in the art can obtain other relevant drawings based on these drawings without employing inventive ability. The arrows in Figures 1 and 6 indicate the direction of blood flow. [Brief explanation of the drawing]

[0081] [Figure 1] This is a schematic diagram of a heart valve stent viewed from a certain angle according to some embodiments of the present disclosure. [Figure 2] This is a schematic diagram of a heart valve stent from a different angle, according to some embodiments of the present disclosure. [Figure 3] This is a schematic enlarged view of area A in Figure 2. [Figure 4] This is a schematic partial diagram of a second support structure according to one embodiment of the present disclosure. [Figure 5] This is a schematic partial diagram of a second support structure according to another embodiment of the present disclosure. [Figure 6] This is a schematic diagram of an artificial heart valve according to some embodiments of the present disclosure. [Figure 7] This is a schematic diagram of a heart valve stent viewed from a certain angle according to another embodiment of the present disclosure. [Figure 8] This is a schematic diagram of a heart valve stent from another angle according to another embodiment of the present disclosure. [Figure 9] This is a schematic enlarged view of area A in Figure 8. [Figure 10] This is a schematic diagram of an artificial heart valve according to another embodiment of the present disclosure. [Figure 11] This is a schematic diagram of an implantable heart valve stent according to an embodiment of the present disclosure, viewed from a certain angle. [Figure 12] This is a schematic diagram of an implantable heart valve stent as seen from another angle, according to an embodiment of the present disclosure. [Figure 13] This is a schematic enlarged view of area A in Figure 12. [Figure 14] This is a schematic diagram of one type of connection configuration of the connection structure according to the embodiments of the present disclosure. [Figure 15] This is a schematic diagram of another type of connection configuration of the connection structure according to the embodiments of this disclosure. [Figure 16] This is a schematic diagram of an artificial heart valve according to another embodiment of the present disclosure. [Figure 17] This is a schematic perspective view of a heart valve stent according to another embodiment of the present disclosure. [Figure 18] This is a schematic perspective view of a heart valve stent from another angle according to another embodiment of the present disclosure. [Figure 19] This is a schematic perspective view of a heart valve stent, valve leaflet, and first cover member according to an embodiment of the present disclosure. [Figure 20]This is a schematic diagram of the braided wire of a heart valve stent according to an embodiment of the present disclosure. [Figure 21] This is a schematic diagram of the braided wire of another heart valve stent according to an embodiment of the present disclosure. [Figure 22] This is a schematic perspective view of another heart valve stent according to an embodiment of the present disclosure. [Figure 23] This is a schematic perspective view of another heart valve stent according to an embodiment of the present disclosure, viewed from a different angle. [Figure 24] This is a schematic diagram of a cardiac prosthesis according to an embodiment of the present disclosure. [Figure 25] This is a schematic perspective view of the second cover member in a cardiac prosthesis according to an embodiment of the present disclosure. [Figure 26] This is a schematic perspective view of the second cover member in another artificial heart valve according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0082] The technical concepts in the embodiments of this disclosure will be described clearly and completely below with reference to the drawings used in the embodiments of this disclosure. The embodiments described are only some, and not all, embodiments of this disclosure. The components in the embodiments of this disclosure shown herein with reference to the drawings can be arranged and designed in various ways. For this reason, the following detailed description of the embodiments of this disclosure shown in the drawings is merely to illustrate selected embodiments of this disclosure and does not limit the scope of the disclosure that is to be protected. Based on the embodiments of this disclosure, all other embodiments that a person skilled in the art could obtain without using their inventive ability also fall within the scope of protection of this disclosure.

[0083] In this disclosure, directions or positional relationships expressed by terms such as “up,” “down,” “left,” “right,” “front,” “back,” “top,” “bottom,” “inside,” “outside,” “intermediate,” “vertical,” “horizontal,” “lateral,” and “vertical” are based on the drawings. These terms are for the sole purpose of better describing this disclosure and its embodiments and do not limit the devices, elements, or components to having a particular direction or being configured or operated in a particular direction.

[0084] Furthermore, some of the terms mentioned above may be used to express meanings other than those indicating direction or positional relationships. For example, the term “above” may, in some cases, be used to indicate a specific dependency or connection. Those skilled in the art will be able to understand the specific meanings of these terms in this disclosure in accordance with the specific context.

[0085] Furthermore, terms such as "attachment," "installation," "provided," "connection," and "linking" should be understood in a broad sense. For example, it may be a fixed connection, a removable connection, or an integral connection. It may also be a mechanical connection or an electrical connection. It may also be a direct connection, an indirect connection via an intermediate object, or the internals of two devices, elements, or components may be in communication. A person skilled in the art will be able to understand the specific meaning of the above terms in this disclosure depending on the specific situation.

[0086] Furthermore, terms such as "first," "second," etc., are primarily used to distinguish between different devices, elements, or components (whether of the same or different specific type or structure), and do not explicitly or implicitly indicate the relative importance or number of the devices, elements, or components in question. Unless otherwise specified, "multiple" means "two or more."

[0087] In the first aspect, one embodiment of the present disclosure provides an (artificial) heart valve stent 10, which includes a support body 100 and at least one protruding extension branch structure 200 connected to the support body 100. A flow passage 120 through which blood flows is defined in the support body 100. The protruding extension branch structure 200 extends outward from the support body 100 to the flow passage 120, and has a protruding extension portion 210 that can contact cardiac tissue, and a gap 300 is formed between the protruding extension branch structure 200 and the support body 100 for accommodating the heart's own valve leaflets 20.

[0088] In the above embodiment, the (artificial) heart valve stent 10 includes a support body 100 and at least one protruding extension branch structure 200 connected to the support body 100. The support body 100 is positioned at the location of the original aortic valve, and a blood flow passage 120 is defined in the middle portion of the support body 100. The protruding extension branch structure 200 is installed extending outward from the support body 100, away from the flow passage 120, and has a protruding extension portion 210 that can contact cardiac tissue (e.g., Valsalva sinus) formed on the protruding extension branch structure 200. As a result, when the (artificial) heart valve stent 10 is placed in the position of the original aortic valve, the protruding extension portion 210 contacts the cardiac tissue and fixes the (artificial) heart valve stent 10 in place, preventing the (artificial) heart valve stent 10 from being displaced under the action of blood pressure on the valve leaflets 20 when the valve leaflets 20 close. This improves the stability and reliability of the placement of the heart valve stent in the position of the original aortic valve and extends the service life of the (artificial) heart valve stent 10. Furthermore, a gap exists between the protruding extension branch structure 200 and the support body 100, which allows the heart's own valve leaflets 20 to be accommodated within this gap when the (artificial) heart valve stent 10 is installed in the position of the original aortic valve. This prevents coronary artery blockage caused by interference between the heart's own valve leaflets 20 and the (artificial) heart valve stent 10, thereby contributing to improved safety during the installation of the (artificial) heart valve stent 10.

[0089] In some embodiments, the support body 100 includes a plurality of support units 110, which define and form the flow passage 120, each of which includes two first support structures 111 for connecting to different valve leaflets 20, and at least one second support structure 112 connected to the two first support structures 111, with a space formed between the two first support structures 111 and the second support structure 112 that can be covered by connecting a cover member.

[0090] In the above embodiment, the (artificial) heart valve stent 10 includes a plurality of support units 110, which are connected to each other to define and form a flow passage 120 through which blood flows. Each support unit 110 includes two first support structures 111 and a second support structure 112 connected to one end of each of the two first support structures 111. A space is formed between the second support structure 112 and the two first support structures 111 that can be covered by connecting a cover member. When this space is covered by connecting a cover member, blood can only flow through the flow passage 120, thereby preventing blood from flowing on the outer periphery of the (artificial) heart valve stent 10.

[0091] For example, there are three support units 110, and these three support units 110 form the support body 100.

[0092] In some embodiments, if the direction in which blood flows through the flow passage 120 defines an upstream and downstream direction, the second support structure 112 is located upstream of the two first support structures 111.

[0093] In the above embodiment, the second support structure 112 is located upstream of the two first support structures 111, that is, a blood inflow end is formed in the direction of the second support structure 112, and a blood outflow end is formed in the direction of the two first support structures 111, so that blood flows in from the direction of the second support structure 112 and flows out from the direction of the first support structures 111.

[0094] In some embodiments, the two first support structures 111 each extend downstream from both ends of the second support structure 112, and the two first support structures 111 merge and connect to each other.

[0095] In the above embodiment, the first ends of the two first support structures 111 are connected to both ends of the second support structure 112, respectively, and the second ends extend downstream of the flow passage 120, where they merge and connect, thereby forming a closed space between the first support structures 111 and the second support structure 112 that can be covered by connecting a cover member. The second ends of the two first support structures 111 can be connected by riveting or welding.

[0096] In some embodiments, each of the support units 110 is connected to the protruding extension branch structure 200, and the protruding extension branch structure 200 is located between two adjacent support units 110 in the circumferential direction of the support body 100.

[0097] In the above embodiment, there are multiple protruding extension branch structures 200, and each support unit 110 is connected to a protruding extension branch structure 200. Specifically, the multiple protruding extension branch structures 200 are installed at intervals and located between two adjacent support units 110 in the circumferential direction of the support body 100. In this way, when the protruding extension portions 210 of the multiple protruding extension branch structures 200 come into contact with cardiac tissue (e.g., the sinus of Valsalva), the reliability and stability of the (artificial) heart valve stent 10 after installation can be effectively improved.

[0098] In some embodiments, each support unit 110 is connected to two of the protruding extension branch structures 200, and the two protruding extension branch structures 200 between two adjacent support units 110 are connected to each other.

[0099] In the above embodiment, the ends of the two protruding extension branch structures 200 located upstream of the flow passage 120 between two adjacent support units 110 are connected, that is, the two protruding extension portions 210 of the two protruding extension branch structures 200 are connected to each other, thereby contributing to improved reliability and stability when the protruding extension portions 210 come into contact with cardiac tissue.

[0100] In some embodiments, the two protruding extension branch structures 200 between two adjacent support units 110 are formed by a single braided wire 131.

[0101] In the above embodiment, the two protruding extension branch structures 200 between two adjacent support units 110 are integrally formed by a single braided wire 131, eliminating the need for further connections by methods such as welding or riveting, and contributing to improved production efficiency of the product.

[0102] In some embodiments, a connecting ring 400 is formed downstream of the first support structure 111.

[0103] In the above embodiment, a connecting ring 400 is formed on the first support structure 111, and the connecting ring 400 is located downstream of the flow passage 120 and is connected to the transport system for the (artificial) heart valve stent 10, enabling the transport system to deliver and retrieve the (artificial) heart valve stent 10.

[0104] In some embodiments, the connecting ring 400 is formed on each of the first support structures 111.

[0105] In the above embodiment, there are multiple connecting rings 400, and all of the multiple connecting rings 400 are located downstream of the flow passage 120. If all of the multiple connecting rings 400 are connected to the transport system for the (artificial) heart valve stent 10, it can contribute to improving the reliability of the delivery of the (artificial) heart valve stent 10.

[0106] In some embodiments, a first rivet knot structure 114 is provided upstream of the connecting ring 400, and the first rivet knot structure 114 forms the connecting ring 400 as a closed ring.

[0107] In the above embodiment, by installing the first rivet knotting structure 114 upstream of the connecting ring 400, the connecting ring 400 is formed as a closed ring structure, which contributes to the connection between the connecting member of the conveying system and the connecting ring 400, and can contribute to improving the reliability of the connection between the connecting member of the conveying system and the connecting ring 400.

[0108] In some embodiments, each support unit 110 and its adjacent support unit 110 are connected by a rivet structure to form a second rivet knot structure 115, in which the first support structure 111 and the second support structure 112 of two adjacent support units 110 are arranged in parallel, and the gap 300 for accommodating the heart's own valve leaflets 20 is formed between the protruding extension branch structure 200 and the first support structure 111 and the second support structure 112 in the second rivet knot structure 115.

[0109] In the above embodiment, each support unit 110 and two adjacent support units 110 are connected by a rivet structure, that is, the connection points between the two first support structures 111 and the second support structure 112 of each support unit 110, and the connection points between the two first support structures 111 and the second support structure 112 of the adjacent support unit 110 are connected by a rivet structure to form a second rivet knot structure 115. In the first rivet knot structure 114, the first support structures 111 and the second support structures 112 of two adjacent support units 110 are arranged in parallel, which contributes to improving the reliability of the connection of each support unit 110, improving the aesthetic appearance of the product, and the first support structures 111 and the second support structures 112 in the protruding extension branch structure 200 and the second rivet knot structure 115 are installed with a gap between them, defining a gap for accommodating the heart's own valve leaflets 20.

[0110] In some embodiments, the two first support structures 111 of each support unit 110 are connected by a rivet structure to form a third rivet connection structure 116.

[0111] In the above embodiment, the connection points between the two first support structures 111 of each support unit 110, located downstream of the flow passage 120, are connected by a rivet structure such as a rivet pipe to form a third rivet connection structure 116. This effectively ensures a secure connection between the ends of the two first support structures 111 of each support unit 110, located downstream of the flow passage 120.

[0112] In some embodiments, along the direction in which blood flows through the flow passage 120, the protruding extension branch structure 200 includes a continuous protruding extension segment 220 and a connecting segment 230, wherein the protruding extension segment 220 is bent and extended in a direction away from the flow passage 120, and the connecting segment 230 is connected at one end to the protruding extension segment 220 and at the other end to the support body 100, and the angle of the angle formed between the protruding extension segment 220 and the axial direction of the flow passage 120 is between 1° and 150°.

[0113] In the above embodiment, the protruding extension segment 220 is located downstream of the flow passage 120, and the connecting segment 230 has one end connected to the protruding extension segment 220 and the other end extending downstream of the flow passage 120 and connected to the first support structure 111 of the support body 100. By setting the angle between the protruding extension segment 220 and the axial direction of the flow passage 120 to 150°, the protruding extension segment 220 can be made to contact cardiac tissue (e.g., sinus of Valsalva) in a position corresponding to the cardiac tissue, and this can contribute to improving the stability of the protruding extension segment 220 when it contacts cardiac tissue.

[0114] Specifically, an installation space is defined between the connecting segment 230 and the first support structure 111 for passing medical devices such as coronary artery stents when they are installed.

[0115] In some embodiments, the horizontal distance a between the end of the connecting segment 230 that connects to the protruding extension segment 220 and the support body 100 located upstream of the flow passage 120 is 1 mm to 20 mm.

[0116] In the above embodiment, by setting the distance a between the end of the connecting segment 230 that connects to the protruding extension segment 220 and the support body 100 located upstream of the flow passage 120 to 1 mm to 20 mm, on the one hand, it is possible to ensure that the protruding extension segment 220 can come into contact with cardiac tissue and prevent the protruding extension segment 220 from excessively protruding and extending, damaging other cardiac tissues, and on the other hand, after the protruding extension segment 220 comes into contact with the side of the protruding extension segment 220 that is close to the support body 100, the protruding extension branch structure 200 and the support body 100 are accommodated in the gap between the protruding extension branch structure 200 and the support body 100, so that the protruding extension segment 20 can be easily accommodated in the gap.

[0117] In some embodiments, the heart valve stent 10 is made by weaving together at least one elongated piece of material.

[0118] In the above embodiment, the elongated material is, for example, a shape memory alloy wire or a nickel-titanium alloy wire. If the (artificial) heart valve stent 10 is made by weaving together a single elongated material, its integrity is relatively high, which can contribute to processing and molding. If the (artificial) heart valve stent 10 is made by weaving together multiple elongated materials, the two elongated materials to be connected can be fixedly connected by rivet tubes or welding. In addition, the connection point of the two elongated materials to be connected can be fixedly connected by welding or screw connections.

[0119] In a second aspect, one embodiment of the present disclosure further provides another heart valve stent 10. The heart valve stent 10 is made by weaving at least one elongated material into a defined shape, and the heart valve stent 10 has a defined flow passage 120 through which blood flows, and at least one elongated material extends outward from the flow passage 120 to form a protruding extension portion 210 that can contact cardiac tissue.

[0120] The heart valve stent 10 according to the embodiments of this disclosure is positioned in the location of the original aortic valve. The heart valve stent 10 is made by weaving together at least one elongated material into a defined shape, and a blood flow passage 120 is defined in the middle of the heart valve stent 10. Exemplarily, the elongated material is the shape memory alloy wire or the nickel-titanium alloy wire. At least one elongated portion of the material extends outward, projecting away from the flow passage 120, thereby forming a protruding extension 210 that can contact cardiac tissue (e.g., the sinus of Valsalva). When the heart valve stent 10 is positioned in the original aortic valve location, the protruding extension 210 contacts the cardiac tissue, securing the heart valve stent 10 and preventing displacement of the heart valve stent 10 under the pressure of blood on the valve leaflets 20 when the leaflets 20 close. This improves the stability and reliability of the placement of the heart valve stent 10 in the original aortic valve location, extends the service life of the heart valve stent 10, and contributes to improved stability of the heart valve stent 10 when used in patients without calcification.

[0121] In some embodiments, the heart valve stent 10 includes a plurality of support units 110, which define and form the flow passage 120, each of which includes two first support structures 111 for connecting to different valve leaflets 20, and a second support structure 112 connected to the two first support structures 111, with a space formed between the two first support structures 111 and the second support structure 112 that can be covered by connecting a cover member.

[0122] In some embodiments, the heart valve stent 10 includes a plurality of support units 110, which are connected to define and form a flow passage 120. Each support unit 110 includes two first support structures 111 and a second support structure 112 connected to one end of each of the two first support structures 111, and a space is formed between the second support structure 112 and the two first support structures 111 that can be covered by connecting a cover member, and when this space is covered by connecting a cover member, blood can only flow through the flow passage 120, thereby preventing blood from flowing on the outer periphery of the heart valve stent 10.

[0123] For example, there are three support units 110.

[0124] In some embodiments, if the direction in which blood flows through the flow passage 120 defines an upstream and downstream direction, the second support structure 112 is located upstream of the two first support structures 111.

[0125] In the above embodiment, the second support structure 112 is located upstream of the two first support structures 111, that is, a blood inflow end is formed in the direction of the second support structure 112, and blood outflow ends are formed in the two first support structures 111, so that blood flows in from the direction of the second support structure 112 and flows out from the direction of the first support structures 111.

[0126] In some embodiments, the two first support structures 111 each extend downstream from both ends of the second support structure 112, and the two first support structures 111 are connected at their second ends.

[0127] In the above embodiment, the first ends of the two first support structures 111 are connected to both ends of the second support structure 112, respectively, and extend downstream of the flow passage 120. The second ends of the two first support structures 111 are also connected to each other, thereby forming a closed space between them and the second support structure 112 that can be covered by connecting a cover member. The second ends of the two first support structures 111 can be connected by riveting or welding.

[0128] In some embodiments, each support unit 110 further includes a third support structure 113, the third support structure 113 forming a connecting ring 400 located downstream of the heart valve stent 10.

[0129] In the above embodiment, the support unit 110 further includes a third support structure 113, the third support structure 113 forming a connecting ring 400 located downstream of the heart valve stent 10. The connecting ring 400 is connected to a transport system for the heart valve stent 10, enabling the transport system to deliver and retrieve the heart valve stent 10.

[0130] Each support unit 110 has two third support structures 113, and the ends of each of the two third support structures 113 located downstream of the heart valve stent 10 are connected to the second ends of the two first support structures 111, respectively, after forming a connecting ring 400.

[0131] In some embodiments, the downstream end of the third support structure 113 is connected to the first support structure 111 after forming a connecting ring 400, and the upstream end of the third support structure 113 is connected to the first support structure 111 after forming a connecting ring 400, while the upstream end of the third support structure 113 is connected to a protruding extension 210 that can contact cardiac tissue. The third support structure 113 and the first support structure 111 may be connected integrally, or they may be fixedly connected by rivet or welding.

[0132] In some embodiments, each support unit 110 has two third support structures 113, with one end of each of the two third support structures 113 connected to the two first support structures 111, and the other ends of the two third support structures 113 each forming the protruding extension portion 210.

[0133] In the above embodiment, each support unit 110 includes two third support structures 113, the two third support structures 113 located on either side of the two first support structures 111, the first end of each third support structure 113 being connected to the downstream end of the two first support structures 111 located downstream of the flow passage 120, and the other end of each forming a protruding extension 210 that can contact cardiac tissue.

[0134] In some embodiments, one connecting ring 400 is formed at the downstream end of each of the third support structures 113.

[0135] In the above embodiment, one connecting ring 400 is formed at the downstream end of each third support structure 113. The connecting ring 400 is connected to the connecting structure of the transport system, allowing the cardiac valve stent 10 to be delivered into cardiac tissue by the delivery mechanism, thereby improving the stability and reliability of the delivery.

[0136] In some embodiments, the protruding extension portion 210 of each support unit 110 and the protruding extension portion 210 of the adjacent support unit 110 are formed by bending the same elongated material, and two adjacent protruding extension portions 210 are formed continuously with each other.

[0137] In the above embodiment, the two adjacent protruding extensions 210 in the two adjacent support units 110 are formed by bending the same elongated material and are formed continuously, which prevents damage to cardiac tissue by the protruding extensions 210 due to stress concentration, and further improves the support strength of the protruding extensions 210, thereby improving the reliability of the installation of the cardiac valve stent 10.

[0138] In some embodiments, each support unit 110 and its adjacent support unit 110 are connected by a rivet structure to form a first rivet-connected structure 114, in which each elongated material is arranged in parallel and two of the protruding extensions 210 are located in the middle.

[0139] In the above embodiment, each support unit 110 and two adjacent support units 110 are connected by a rivet structure, that is, the connection points between the two first support structures 111 and the second support structure 112 of each support unit 110, and the connection points between the two first support structures 111 and the second support structure 112 of the adjacent support unit 110 are connected by a rivet structure to form two first rivet knot structures 114, and the third support structure 113 is also connected to the first rivet knot structures 114. In the first rivet knot structures 114, each elongated material is arranged in parallel, which contributes to improving the reliability of the connection of each support unit 110, improving the aesthetic appearance of the product, and the protruding extension portion 210 of each support unit 110 is located in the middle of the support unit 110, which contributes to contacting the cardiac tissue.

[0140] In some embodiments, the two first support structures 111 of each support unit 110 are connected by a rivet structure to form a second rivet-connected structure 115, and the third support structure 113 is also connected to the second rivet-connected structure 115.

[0141] In the above embodiment, the connection points between the two first support structures 111 of each support unit 110, located downstream of the flow passage 120, are connected by a rivet structure such as a rivet pipe to form a second rivet connection structure 115. The two third support structures 113 of each support unit 110 are also connected to the second rivet connection structure 115, effectively ensuring a reliable connection between the two first support structures 111 and the two third support structures 113 in each support unit 110.

[0142] In some embodiments, the angle formed between the protruding extension direction of the protruding extension portion 210 and the direction perpendicular to the axial direction of the flow passage 120 is 15° to 90°.

[0143] In the above embodiment, by setting the angle of the angle formed between the plane on which the protruding extension portion 210 is located and the direction perpendicular to the axial direction of the flow passage 120 to 15° to 90°, when the cardiac valve stent 10 is positioned in the original aortic valve position, the protruding extension portion 210 contributes to contacting the cardiac tissue in accordance with the position of the cardiac tissue, thereby contributing to improved stability of contact between the protruding extension portion 210 and the cardiac tissue.

[0144] In some embodiments, along the direction in which blood flows through the flow passage 120, the third support structure 113 includes a continuous protruding extension segment 220, a transition segment 240, and a connecting segment 230, wherein the protruding extension segment 220 forms the protruding extension portion 210, the transition segment 240 has one end connected to the protruding extension segment 220 and the other end bent and extended in a direction away from the flow passage 120, with an angle of 60° to 150° between the angle formed between the transition segment 240 and a direction perpendicular to the axial direction of the flow passage 120, and the connecting segment 230 has one end connected to the transition segment 240 and the other end connected to the first support structure 111.

[0145] In the above embodiment, the third support structure 113 includes a protruding extension segment 220, a transition segment 240, and a connecting segment 230 that are sequentially connected along the flow direction of the flow passage 120. The protruding extension segment 220 protrudes outward from the flow passage 120 to form a protruding extension portion 210 that can contact cardiac tissue, and the transition segment 240 has one end connected to the protruding extension segment 220 and the other end bent and extends in a direction away from the flow passage 120, with an angle of 60° to 150° between the transition segment and a direction perpendicular to the axial direction of the flow passage 120, thereby allowing the cardiac valve stent 10 to widen the original aortic valve area and ensure normal blood flow. The connecting segment 230 has one end connected to the transition segment 240, and the other end bends and extends toward the first support structure 111 to form a connecting ring 400 at the downstream end of the flow passage 120, after which it is connected to the first support structure 111. This defines a relatively large space between the third support structure 113 and the valve leaflet 20, so that when a coronary artery stent is placed in a patient, the coronary artery stent can be installed using this space.

[0146] In a third aspect, one embodiment of the present disclosure provides an implantable heart valve stent 10. The heart valve stent 10 includes a plurality of support units 110, which define and form a flow passage 120 through which blood flows, and at least one of the support units 110 includes a protruding extension branch structure 200, the protruding extension branch structure 200 protruding and extending in a direction away from the flow passage 120 to form a protruding extension portion 210 that can contact cardiac tissue, and the protruding extension branch structure 200 extending upstream of the flow passage 120 to form a connecting structure 250 that can be connected to a cover member.

[0147] In the above embodiment, the heart valve stent 10 includes a plurality of support units 110, which are connected to each other to define and form a flow passage 120 through which blood flows. At least one support unit 110 includes a protruding extension branch structure 200, which protrudes and extends in a direction away from the flow passage 120 to form a protruding extension portion 210 that can contact cardiac tissue. This allows the protruding extension portion 210 to contact cardiac tissue when the heart valve stent 10 is placed in the original aortic valve position, thereby fixing the heart valve stent 10 in place. This prevents the heart valve stent 10 from being displaced under the pressure of blood on the valve leaflets 20 when the leaflets 20 close, improving the stability and reliability of the placement of the heart valve stent in the original aortic valve position and extending the service life of the heart valve stent 10. Furthermore, the protruding extension portion 210 extends upstream of the flow passage 120 to form a connecting structure 250 that can be connected to the sealing cover member. After the sealing cover member and the connecting structure 250 are connected, it is possible to prevent blood from flowing on the outer circumference of the flow passage 120, thereby improving the fluidity of blood when it flows along the axial direction of the flow passage 120.

[0148] Optionally, in patients with relatively severe calcification of the valve leaflet 20, the protruding extension 210 directly contacts the calcified valve leaflet 20 of the patient. Because the hardness of the calcified valve leaflet 20 is relatively high, the protruding extension 210 effectively provides support when it contacts the calcified valve leaflet 20, ensuring reliability and stability when the heart valve is positioned in its original location.

[0149] In some embodiments, each support unit 110 includes two first support structures 111 for connecting to different valve leaflets 20, and a first space 600-A is formed between the two first support structures 111 and the connecting structure 250, which can be covered by connecting a cover member.

[0150] In the above embodiment, each support unit 110 includes two first support structures 111, and a first space 600-A is formed between the two first support structures 111 and the connecting structure 250, which can be covered by connecting a cover member. When this space is covered by connecting a cover member, blood can only flow through the flow passage 120, thereby preventing blood from flowing on the outer periphery of the heart valve stent 10.

[0151] In some embodiments, if the direction in which blood flows through the flow passage 120 defines an upstream and downstream direction, the connecting structure 250 is located upstream of the two first support structures 111 and is formed in continuity with the upstream end of the protruding extension branch structure 200 located upstream of the flow passage 120 to form the connecting structure 250.

[0152] In the above embodiment, the connecting structure 250 is located upstream of the two first support structures 111, that is, a blood inflow end is formed in the direction of the connecting structure 250, and a blood outflow end is formed in the direction of the two first support structures 111, so that blood flows in from the direction of the connecting structure 250 and flows out from the direction of the first support structures 111. The connecting structure 250 is formed in continuity with the end of the protruding extension branch structure 200 located upstream of the flow passage 120, and is formed as a connecting structure 250 that can be covered by connecting a cover member.

[0153] In some embodiments, the connection structure 250 includes at least one subconnection structure 251, the at least one subconnection structure 251 being installed overlapping with or spaced apart from the connection structure 250.

[0154] In the above embodiment, at least one sub-connection structure 251 is connected to the connection structure 250, and at least two support structures are installed overlapping or spaced apart, thereby increasing the support strength when the connection structure 250 is supported at the original heart valve site, and improving the stability when the heart valve stent 10 is installed.

[0155] In some embodiments, the two first support structures 111 each extend downstream from both ends of the connecting structure 250, and the two first support structures 111 merge and connect to each other.

[0156] In the above embodiment, the first ends of the two first support structures 111 are connected to both ends of the connecting structure 250, respectively, and the second ends extend downstream of the flow passage 120, where they merge and connect, thereby forming a closed space between the two first support structures 111 and the connecting structure 250 that can be covered by connecting a cover member.

[0157] For example, the connection method between the second ends of the two first support structures 111, and the connection method between the two first support structures 111 and the connecting structure 250, can be by riveting or welding.

[0158] In some embodiments, each of the support units 110 includes the protruding extension branch structure 200, and the protruding extension branch structure 200 is located between two adjacent support units 110 in the circumferential direction of the flow passage 120.

[0159] In the above embodiment, there are multiple protruding extension branch structures 200, and each support unit 110 includes a protruding extension branch structure 200. Specifically, the multiple protruding extension branch structures 200 are installed at intervals and located between two adjacent support units 110 in the circumferential direction of the support body 100. In this way, the protruding extension portions 210 of the multiple protruding extension branch structures 200 come into contact with cardiac tissue (e.g., calcified valve leaflets 20), thereby effectively improving the reliability and stability of the cardiac valve stent 10 after installation.

[0160] In some embodiments, each support unit 110 includes two of the protruding extension branch structures 200, and the connecting structures 250 formed by the two protruding extension branch structures 200 are connected to each other.

[0161] In the above embodiment, the connection structures 250 formed by the two protruding extension branch structures 200 of each support unit 110 are connected to each other (for example, by integral connection, welding, or riveting), which contributes to improved stability when covering the space formed between the connection structure 250 and the first support structure 111 by connecting the sealing cover member, contributes to improved product integrity, and improves reliability and stability when the heart valve stent 10 is placed in the location of the original heart valve.

[0162] In some embodiments, a second space 600-B for passing medical equipment is formed between each of the protruding extension branch structures 200 and the first support structure 111.

[0163] In the above embodiment, a second space 600-B is formed between each protruding extension branch structure 200 and the first support structure 111 connected thereto, allowing medical devices such as coronary artery stents to pass through. This makes it possible to easily attach medical devices such as coronary artery stents after the heart valve stent 10 has been installed.

[0164] In some embodiments, the protruding extension branch structure 200 and the first support structure 111 are made by braiding together a single braided wire 131.

[0165] In the above embodiment, the protruding extension branch structure 200 and the first support structure 111 are made by braiding a single braided wire 131, and since these two structures are formed in a continuous manner, further connections by methods such as welding or riveting are unnecessary, which can contribute to improving the production efficiency of the product and improving the integrity of the product.

[0166] In some embodiments, the protruding extension branch structure 200 has a connecting ring 400 formed at the end located downstream of the flow passage 120.

[0167] In the above embodiment, a connecting ring 400 is provided on the protruding extension branch structure 200, and the connecting ring 400 is located downstream of the flow passage 120 and is connected to a transport system for the (artificial) heart valve stent 10, enabling the transport system to deliver and retrieve the heart valve stent 10.

[0168] In some embodiments, each support unit 110 and its adjacent support unit 110 are connected by a rivet structure to form a first rivet knot structure 114, in which the first support structures 111 and connecting structures 250 of two adjacent support units 110 are arranged in parallel, and the end of the protruding extension branch structure 200 located upstream of the flow passage 120 is located in the first rivet knot structure 114.

[0169] In the above embodiment, each support unit 110 and two adjacent support units 110 are connected by a rivet structure, that is, the connection points between the two first support structures 111 of each support unit 110 and the connecting structure 250, and the connection points between the two first support structures 111 of the adjacent support unit 110 and the connecting structure 250 are connected by a rivet structure to form a first rivet knot structure 114. In the first rivet knot structure 114, the first support structures 111 of two adjacent support units 110 and the connecting structure 250 are arranged in parallel, which contributes to improving the reliability of the connection of each support unit 110, improving the aesthetic appearance of the product, and the end of the protruding extension branch structure 200 located upstream of the flow passage 120 is also located in the second rivet knot structure 115 and is formed continuously with the connecting structure 250.

[0170] In some embodiments, the two first support structures 111 of each support unit 110 are connected by a rivet structure to form a second rivet-connected structure 115.

[0171] In the above embodiment, the connection points between the two first support structures 111 of each support unit 110, located downstream of the flow passage 120, are connected by a rivet structure such as a rivet pipe to form a second rivet connection structure 115. This effectively ensures a secure connection between the ends of the two first support structures 111 of each support unit 110, located downstream of the flow passage 120.

[0172] In some embodiments, the protruding extension branch structure 200 includes a first connecting segment 230, a contact segment, and a second connecting segment 230, which are connected in sequence, the first connecting segment 230 being connected to the first riveted structure 114, the contact segment having a first end connected to the first connecting segment 230 and a second end protruding and extending away from the flow passage 120, and the second connecting segment 230 having one end connected to the second end of the contact segment and the other end connected to the first support structure 111.

[0173] In the above embodiment, the protruding extension branch structure 200 includes a first connecting segment 230, a contact segment, and a second connecting segment 230, which are connected in sequence. At least a portion of the first connecting segment 230 is located in the first riveted structure 114 and is formed in continuity with the connecting structure 250. The contact segment has a first end connected to the first connecting segment 230, and its second end protrudes outward from the flow passage 120 to form a protruding extension portion 210 that can contact cardiac tissue. The second connecting segment 230 has one end connected to the contact segment, and its other end extends in a direction closer to the flow passage 120 and is connected to the first support structure 111.

[0174] In some embodiments, the angle α formed by the contact segment and the axial direction of the flow passage 120 is between 10° and 150°.

[0175] In the above embodiment, by setting the angle α between the contact segment and the axial direction of the flow passage 120 to 10° to 150°, it is possible to contribute to the contact segment contacting the cardiac tissue (for example, the calcified valve leaflet 20) and to improve the stability of the contact segment when it contacts the cardiac tissue.

[0176] In some embodiments, the distance b between the second end of the contact segment and the first connecting segment 230 is 1 mm to 20 mm.

[0177] In the above embodiment, the first connecting segment 230 is connected to the first riveted structure 114 along the axial direction of the flow passage 120. By setting the distance b between the second end of the contact segment and the first connecting segment 230 to 1 mm to 20 mm, it is possible to ensure that the contact segment contacts the cardiac tissue, while preventing the contact segment from excessively protruding outward from the flow passage 120 and damaging the cardiac tissue.

[0178] In some embodiments, the implantable heart valve stent 10 is made by braiding at least one braided wire 131.

[0179] In the above embodiment, the braided wire 131 is, for example, a shape memory alloy wire or a nickel-titanium alloy wire. When the heart valve stent 10 is made by braiding a single braided wire 131, its integrity is relatively high, which can contribute to processing and molding. When the heart valve stent 10 is made by braiding multiple elongated materials, the two elongated materials to be connected can be fixedly connected by rivet tubes or welding. In addition, the connection point of the two elongated materials to be connected can be fixedly connected by welding or screw connections.

[0180] In some embodiments, the connecting structure 250 is made by weaving together diameter-changing shape memory alloy wires, or a shape memory alloy tube 500 is fitted around a part of the outer circumference of the connecting structure 250.

[0181] In the above embodiment, the connecting structure 250 is made by weaving together diameter-changing shape memory alloy wires, or by encircling a part of the outer circumference of the connecting structure 250 with a shape memory alloy tube 500. This increases the diameter of a part of the connecting structure 250, thereby increasing the support force of the support provided by the heart valve stent 10 and improving the stability of the support.

[0182] In some embodiments, the heart valve stent 10, with the first and / or second and / or third surfaces described above, includes an elongated material or braided wire 131, which may include a shape memory alloy wire.

[0183] In the heart valve stent 10 according to the first and / or second aspects described above, in the above embodiment, the (artificial) heart valve stent 10 is made by braiding at least one shape memory alloy wire, the shape memory alloy wire is deformable when subjected to an external force and can return to its original shape when the external force is released, the artificial valve stent can be easily fed in by a transport system after the shape memory alloy wire has been deformed by an external force, and after the artificial valve stent has been fed into the original aortic valve site, the shape memory alloy wire quickly returns to its original shape, thereby improving the reliability of positioning and attaching the heart valve stent 10 to the aortic valve site. If the heart valve stent 10 is made by braiding multiple shape memory alloy wires, the two shape memory alloy wires to be connected can be fixedly connected by riveting or welding. The heart valve stent 10 can also be fixedly connected by welding or screw connections.

[0184] In some embodiments, the heart valve stent 10 with the first and / or second surfaces described above is made of a second support structure 112 woven from at least one diameter-changing shape memory alloy wire, or a shape memory alloy tube 500 is fitted around a portion of the outer circumference of the second support structure 112.

[0185] In the above embodiment, the heart valve stent 10 with the first and / or second surfaces described above has a second support structure 112 made by weaving together diameter-changing shape memory alloy wires, or a shape memory alloy tube 500 is fitted around a part of the outer circumference of the second support structure 112. By increasing the diameter of a part of the second support structure 112, the supporting force of the support by the heart valve stent 10 can be increased and the stability of the support can be improved.

[0186] In a fourth aspect, embodiments of the present disclosure further provide other prosthetic heart valves 1. The other prosthetic heart valves 1 include an (artificial) heart valve stent 10, which is a heart valve stent 10 with a first or second aspect, or an implantable heart valve stent 10 with a third aspect; a valve leaflet 20 provided in the flow passage 120 and connected to a first support structure 111 of the (artificial) heart valve stent 10; a first sealing cover member 30 configured to cover by connection the space formed between the two first support structures 111 and the second support structure 112 of the (artificial) heart valve stent 10; and a second sealing cover member 40 installed so as to surround the outer periphery of the (artificial) heart valve stent 10. In some embodiments, the second sealing cover member 40 is installed so as to surround the outer periphery of the first sealing cover member 30 and is sealedly connected to the first sealing cover member 30.

[0187] In the above embodiment, the valve leaflets 20 are located within the flow passage 120 and connected to the first support structure 111 of the heart valve stent 10, allowing control of blood flow by opening and closing the valve leaflets 20. For example, when the heart contracts, the valve leaflets 20 open to send blood from the heart to the rest of the body via the aorta, and when the heart relaxes, the valve leaflets 20 close in a timely manner to prevent blood from returning from the aorta to the ventricles. First sealing cover members 30 are installed in the space formed between the two first support structures 111 and the second support structure 112 of each support unit 110 of the heart valve stent 10, thereby preventing blood from flowing on the outer periphery of the heart valve stent 10 and ensuring that blood flows in from the blood inlet end and out from the blood outlet end. A second sealing cover member 40 is installed to surround the outer periphery of the (artificial) heart valve stent 10 and is configured to prevent backflow of blood and prevent perivalvular backflow.

[0188] In some embodiments, the second sealing cover member 40 is disc-shaped, and the outer peripheral edge of the second sealing cover member 40 is bent downstream of the heart valve stent 10 to form a protruding edge.

[0189] In the above embodiment, the second sealing cover member 40 is disc-shaped, so that when the heart valve stent 10 is positioned in the original aortic valve position, the second sealing cover member 40 abuts against the original heart valve tissue, and the outer peripheral edge of the second sealing cover member 40 bends downstream of the heart valve stent 10 to form a protruding edge. In this way, when the valve leaflets 20 close, blood can only flow from the valve leaflets 20 upwards above the second sealing cover member 40, flowing above the second sealing cover member 40, effectively preventing backflow of blood and preventing circumvalvular backflow.

[0190] In some embodiments, the material of the valve leaflet 20 is one of polymer materials, biomaterials, and tissue engineering materials.

[0191] In the embodiments described above, the material of the valve leaflet 20 is, for example, bovine pericardium, porcine pericardium, bovine / porcine heart valve material, etc.

[0192] In some embodiments, the method of connecting the valve leaflet 20 to the first support structure 111 of the (artificial) heart valve stent 10 is one of adhesive, hot melt, or polymer adhesive.

[0193] In the above embodiment, the valve leaflets 20 are fixedly connected to the first support structure 111 of the (artificial) heart valve stent 10 by one of the following methods: adhesive bonding, hot melt bonding, or polymer bonding. This prevents damage or detachment of the valve leaflets 20 due to stress concentration and contributes to improving the product's service life.

[0194] In the fifth aspect, one embodiment of the present disclosure further provides another heart valve stent 10 comprising a support body 100 and at least one protruding extension branch structure 200. The support body 100 comprises a plurality of support units 110, which define and form a blood passage 120, each of which comprises two first support structures 111 for connecting to different valve leaflets 20, and at least one of the support units 110 comprises a second support structure 112, the second support structure 112 being located on the side of the first support structure 111 closer to its adjacent support unit 110. The protruding extension branch structure 200 is fixed relative to two adjacent support units 110 and extends from the support body 100 outward from the passage 120, forming a gap 300 between the protruding extension branch structure 200 and the support body 100 that accommodates the heart's own valve leaflets 20.

[0195] This disclosure describes how, by installing a first support structure 111 and a second support structure 112 to form a support body 100, the structure of the support body 100 becomes stronger, the passage 120 is less likely to deform, and by installing a protruding extension branch structure 200 that contacts cardiac tissue, the cardiac valve stent 10 becomes more secure and less likely to come loose after being implanted in the heart, thereby extending the service life of the cardiac valve stent 10 and reducing the risk of the patient needing valve replacement.

[0196] In some embodiments, each support unit 110 includes two of the second support structures 112, with the two second support structures 112 in each support unit 110 being provided on both sides of the two first support structures 111.

[0197] In the implementation process described above, the overall structure of the support body 100 can be made stronger by installing two first support structures 111 and two second support structures 112 on both sides of the two first support structures 111.

[0198] In some embodiments, each support unit 110 includes a third support structure 113 connected to two of the first support structures 111, and a space is formed between the two first support structures 111 and the third support structure 113 that is covered by the connection of a first cover member 50.

[0199] In the above implementation process, by installing the third support structure 113, a space covered by the first cover member 50 is formed by the third support structure 113 and the first support structure 111, thereby preventing the backflow of blood.

[0200] In some embodiments, each of the first support structures 111 is fixed relative to one of the protruding extension branch structures 200, and each of the protruding extension branch structures 200 is fixedly connected relative to two adjacent first support structures 111 belonging to each of two adjacent support units 110, with the intermediate portion of the protruding extension branch structure 200 forming a protruding extension portion 210 for contact with cardiac tissue.

[0201] In the above implementation process, by connecting each protruding extension branch structure 200 with the two adjacent first support structures 111, the overall structure of the cardiac valve stent 10 can be made more stable. By forming a protruding extension portion 210 with the intermediate portion of the protruding extension branch structure 200, contact with cardiac tissue can be achieved, and the cardiac valve stent 10 can be more stably positioned in a predetermined location in the heart.

[0202] In some embodiments, two adjacent second support structures 112, each belonging to one of two adjacent support units 110, are located along the circumferential direction of the heart valve stent 10, between projecting extension branch structures 200 that connect to these two support units 110.

[0203] In the above implementation process, the two adjacent second support structures 112 belonging to each of the two adjacent support units 110 are positioned along the circumferential direction of the heart valve stent 10 between the protruding extension branch structures 200 that connect to the two support units 110. This allows the second support structures 112 to perform their support role more effectively and to make the structure of the heart valve stent 10 more robust.

[0204] In some embodiments, two adjacent second support structures 112, each belonging to one of two adjacent support units 110, are located inside the protruding extension branch structure 200 that connects to the two support units 110 along the radial direction of the heart valve stent 10.

[0205] In the above implementation process, the two adjacent second support structures 112 belonging to each of the two adjacent support units 110 are positioned along the radial direction of the heart valve stent 10, inside the protruding extension branch structure 200 that connects to these two support units 110. This allows the second support structures 112 to perform their support role more effectively, making the structure of the heart valve stent 10 more robust. Furthermore, the formation of a gap 300 between the protruding extension branch structure 200 and the support body 100 that accommodates the heart's own valve leaflets 20 contributes to the protruding extension branch structure 200 contacting cardiac tissue, allowing the heart valve stent 10 to be positioned more stably in the predetermined location in the heart.

[0206] In some embodiments, the downstream portions of the two first support structures 111 of the support unit 110 and the downstream portions of the two protruding extension branch structures 200 are connected by a rivet structure to form a first rivet connection structure 114, and these two protruding extension branch structures 200 are two protruding extension branch structures 200 that are fixed relative to the two first support structures 111.

[0207] In the above implementation process, by connecting the first support structure 111 and the protruding extension branch structure 200 with a rivet structure, the structures of the first support structure 111 and the protruding extension branch structure 200 become less prone to deformation and stronger, thereby making the overall structure of the heart valve stent 10 stronger.

[0208] In some embodiments, each of the second support structures 112 is fixed relative to one of the protruding extension branch structures 200, the intermediate portion of which forms a protruding extension portion 210 for contact with cardiac tissue.

[0209] In the above implementation process, each protruding extension branch structure 200 is connected to one second support structure 112, thereby making the overall structure of the cardiac valve stent 10 more stable. Furthermore, by forming a protruding extension portion 210 with the intermediate portion of the protruding extension branch structure 200, contact with cardiac tissue is achieved, allowing the cardiac valve stent 10 to be positioned more stably in a predetermined location in the heart.

[0210] In some embodiments, portions of two adjacent second support structures 112, each belonging to one of two adjacent support units 110, are located along the circumferential direction of the heart valve stent 10 between projecting extension branch structures 200 that connect to these two support units 110.

[0211] In the above implementation process, a portion of two adjacent second support structures 112 belonging to each of two adjacent support units 110 is positioned along the circumferential direction of the heart valve stent 10 between the protruding extension branch structures 200 that connect to these two support units 110. This allows the second support structures 112 to perform their support role more effectively and to make the structure of the heart valve stent 10 more robust.

[0212] In some embodiments, portions of two adjacent second support structures 112, each belonging to one of two adjacent support units 110, are located inside the projecting extension branch structure 200 that connects to these two support units 110 along the radial direction of the heart valve stent 10.

[0213] In the above implementation process, a portion of the two adjacent second support structures 112 belonging to each of the two adjacent support units 110 is located inside the protruding extension branch structure 200 that connects to these two support units 110, along the radial direction of the heart valve stent 10. This allows the second support structures 112 to perform their support role more effectively, making the structure of the heart valve stent 10 more robust. Furthermore, a gap 300 is formed between the protruding extension branch structure 200 and the support body 100 to accommodate the heart's own valve leaflets 20, which contributes to the protruding extension branch structure 200 contacting the cardiac tissue, allowing the heart valve stent 10 to be positioned more stably in the predetermined location in the heart.

[0214] In some embodiments, the downstream portions of the two first support structures 111 of the support unit 110 are connected by a rivet structure to form a first rivet knot structure 114, and the downstream portion of the protruding extension branch structure 200 and the second support structure 112 are connected by a rivet structure to form a second rivet knot structure 115.

[0215] In the above implementation process, the rivet structure connects the two first support structures 111 of the support unit 110, and connects the protruding extension branch structure 200 and the second support structure 112. This makes the structures of the first support structure 111, the protruding extension branch structure 200, and the second support structure 112 less prone to deformation and more robust, thereby making the overall structure of the heart valve stent 10 more robust.

[0216] In some embodiments, the upstream portions of two adjacent first support structures 111 belonging to each of two adjacent support units 110, the upstream portions of two adjacent second support structures 112, and the downstream portions of two adjacent third support structures 113 are connected by a rivet structure to form a third rivet-connected structure 116.

[0217] In the above implementation process, by connecting the first support structure 111, the second support structure 112, and the third support structure 113 with a rivet structure, the structures of the first support structure 111, the second support structure 112, and the third support structure 113 become less prone to deformation and stronger, thereby making the overall structure of the heart valve stent 10 stronger.

[0218] In some embodiments, each support unit 110 is formed by braiding one braided wire 131, and each protruding extension branch structure 200 is formed by another braided wire 131.

[0219] In the above implementation process, by braiding one braided wire 131 to form one support unit 110, it is possible to contribute to the fabrication of the support unit 110, eliminating the need for other connecting structures, and making the structure of the support unit 110 simpler and stronger. By forming a protruding extended branch structure 200 with another braided wire 131, it is possible to contribute to the formation of a gap 300 between the protruding extended branch structure 200 and the support body 100 that accommodates the heart's own valve leaflets 20, allowing the protruding extended branch structure 200 to come into contact with the cardiac tissue.

[0220] In some embodiments, the braided wire 131 includes a diameter-changing portion 134, the diameter of which is larger than the diameter of the other portion, and the diameter-changing portion 134 is provided in correspondence with the rivet structure.

[0221] In the above implementation process, by providing the diameter change portion 134 of the braided wire 131 in accordance with the rivet structure, it can contribute to the rivet connection of the braided wire 131, making it less likely for the braided wire 131 to slide within the rivet knot structure or to come out of the rivet knot structure, resulting in a stronger rivet connection.

[0222] In some embodiments, the braided wire 131 is made of a diameter-changing shape memory alloy wire, thereby forming the diameter-changing portion 134, or a shape memory alloy tube 500 is fitted around the outer circumference of the braided wire 131, and the portion fitted with the shape memory alloy tube 500 is the diameter-changing portion 134.

[0223] In the above implementation process, by forming the diameter-changing section 134 using a diameter-changing shape memory alloy wire as the braided wire 131, the process of attaching the rivet structure can be simplified. Furthermore, by forming the diameter-changing section 134 by encircling the outer circumference of the braided wire 131 with a shape memory alloy tube 500, the manufacturing process of braiding the support unit 110 or the protruding extension branch structure 200 can be simplified.

[0224] In some embodiments, a connecting ring 400 is formed downstream of each support unit 110.

[0225] In the above implementation process, the connecting ring 400 is formed downstream of the support unit 110, allowing the support unit 110 to be formed by weaving with a single braided wire 131, thereby making the structure of the support unit 110 more robust.

[0226] In the sixth aspect, one embodiment of the present disclosure further provides another artificial cardiac valve 1. The other artificial cardiac valve 1 includes the cardiac valve stent 10 described above, a valve leaflet 20 provided in the passage 120 and connected to a first support structure 111 of the cardiac valve stent 10, and a first cover member 50 configured to cover by connection the space formed between the two first support structures 111 and the third support structure 113 of the support unit 110 of the cardiac valve stent 10.

[0227] In the above implementation process, by installing the first support structure 111 and the second support structure 112 to form the support body 100, the structure of the support body 100 becomes stronger, the passage 120 is less likely to deform, and by installing the protruding extension branch structure 200 that abuts against cardiac tissue, the cardiac valve stent 10 becomes more secure and less likely to come loose after being implanted in the heart, extending the service life of the cardiac valve stent 10 and reducing the risk of the patient needing valve replacement again. By installing the valve leaflets 20 and the first cover member 50, blood flows from upstream to downstream of the support body 100, preventing backflow.

[0228] In some embodiments, the artificial heart valve 1 further includes a second cover member 60, which is positioned to surround the outer circumference of the heart valve stent 10, with the upstream end of the second cover member 60 connected to the first cover member 50, and the circumference of the second cover member 60 gradually increases and then gradually decreases from the upstream end to the downstream end.

[0229] In the above implementation process, by installing the second cover member 60 on the outer circumference of the heart valve stent 10, the second cover member 60 comes into contact with the cardiac tissue, further preventing blood reflux. Furthermore, by having the circumference of the second cover member 60 gradually increase from the upstream end to the downstream end and then gradually decrease, the middle portion of the outer circumference of the second cover member 60 comes into contact with the cardiac tissue, resulting in a better effect in preventing blood reflux.

[0230] In some embodiments, an annular first projection 601 is formed at the downstream end of the second cover member 60, and the first projection 601 is formed toward the downstream of the heart valve stent 10.

[0231] In the above implementation process, by installing the first protruding edge 601 at the downstream end of the second cover member 60, the effect of preventing blood backflow is improved.

[0232] In some embodiments, the first protruding edge 601 and the second cover member 60 are formed with a housing notch 602, and the housing notch 602 is configured to accommodate the support body 100.

[0233] In the above implementation process, by forming a housing notch 602 in the first protruding edge 601 and the second cover member 60 for accommodating the support body 100, the first protruding edge 601 and the second cover member 60 and the support body 100 can be brought into closer contact, preventing backflow of blood between the first protruding edge 601 and the second cover member 60 and the support body 100.

[0234] In some embodiments, an annular second projection 703 is formed on the outer peripheral edge of the second cover member 60, and the second projection 703 is formed toward the downstream of the heart valve stent 10.

[0235] In the above implementation process, providing a second protruding edge 703 on the outer peripheral edge of the second cover member 60 provides a better effect in preventing blood backflow.

[0236] In some embodiments, the second protruding edge 703 is provided on the outermost edge of the second cover member 60, where the circumference is greatest.

[0237] In the above implementation process, by providing the second protruding edge 703 on the outermost edge of the second cover member 60 with the largest circumference, the second protruding edge 703 comes into contact with the cardiac tissue, resulting in a better effect in preventing the backflow of blood.

[0238] The proposed technology described herein has the following effects: 1. This disclosure provides at least one protruding extension branch structure connected to a support body, and the protruding extension branch structure protrudes and extends outward from the support body to the outside of the flow passage, forming a protruding extension portion that contacts cardiac tissue, thereby significantly reducing the risk of displacement of the cardiac valve stent in patients with regurgitation. 2. In this disclosure, a gap is formed between the protruding extension and the supporting body to accommodate the heart's own valve leaflets, thereby reducing the risk of coronary artery blockage after the placement of the heart valve stent. 3. The heart valve stent relating to this disclosure is made by braiding shape memory alloy wire and has a connecting ring formed to connect to a transport system, thereby enabling complete recovery of the heart valve stent. 4. The cardiac valve stent related to this disclosure has a longer service life. 5. The valve leaflets relating to this disclosure are made of polymer material and can contribute to extending the service life of the valve leaflets. 6. The artificial heart valves relating to this disclosure are relatively small in volume and therefore less likely to cause biocompatibility. 7. The valve leaflets according to this disclosure are uniformly applied to the surface of a heart valve stent using a polymer material, resulting in greater adhesion and preventing damage or detachment of the valve leaflets due to excessive stress during sewing with sutures.

[0239] Other structures and advantages of this disclosure will be described in the following sections, or some structures and advantages may be inferred from the specification, confirmed without objection, or become apparent by practicing the above-described technology of this disclosure.

[0240] To further clarify the above-mentioned objectives, structure, and advantages of this disclosure, preferred embodiments are described below in detail with reference to the drawings.

[0241] As shown in Figures 1, 2, and 6, embodiments of the present disclosure provide a (artificial) heart valve stent 10. The (artificial) heart valve stent 10 includes a support body 100 and at least one protruding extension branch structure 200 connected to the support body 100. A flow passage 120 through which blood flows is defined in the support body 100. The protruding extension branch structure 200 extends outward from the support body 100 to the flow passage 120 and has a protruding extension portion 210 that can contact cardiac tissue, and a gap 300 is formed between the protruding extension branch structure 200 and the support body 100 for accommodating the heart's own valve leaflets.

[0242] In the above embodiment, the (artificial) heart valve stent 10 includes a support body 100 and at least one protruding extension branch structure 200 connected to the support body 100. The support body 100 is positioned at the location of the original aortic valve, and a blood flow passage 120 is defined in the middle of the support body 100. The protruding extension branch structure 200 is positioned extending outward from the support body 100, away from the blood flow passage 120, and has a protruding extension portion 210 that can contact cardiac tissue (e.g., sinus of Valsalva). This allows the protruding extension portion 210 to contact cardiac tissue when the heart valve stent is positioned at the location of the original aortic valve, thereby fixing the heart valve stent in place and preventing displacement of the heart valve stent under the action of blood pressure on the leaflets 20 when the leaflets 20 close. This improves the stability and reliability of the placement of the heart valve stent at the location of the original aortic valve and extends the service life of the heart valve stent. Furthermore, a gap exists between the protruding extension branch structure 200 and the support body 100. This allows the heart's own valve leaflets to be accommodated within this gap when the heart valve stent is installed in the original aortic valve position, preventing coronary artery blockage caused by interference between the heart's own valve leaflets and the heart valve stent, thereby contributing to improved safety during the installation of the (artificial) heart valve stent 10.

[0243] As shown in Figure 2, in some embodiments, the support body 100 includes a plurality of support units 110, which define and form a flow passage 120. Each support unit 110 includes two first support structures 111 for connecting to different valve leaflets 20, and at least one second support structure 112 connected to the two first support structures 111. A space is formed between the two first support structures 111 and the second support structure 112 that can be covered by connecting a cover member.

[0244] In the above embodiment, the heart valve stent includes a plurality of support units 110, which are connected to each other to define a flow passage 120 through which blood flows. Each support unit 110 includes two first support structures 111 and a second support structure 112 connected to one end of each of the two first support structures 111. A space is formed between the second support structure 112 and the two first support structures 111 that can be covered by connecting a cover member. When this space is covered by connecting a cover member, blood can only flow through the flow passage 120, thereby preventing blood from flowing on the outer circumference of the heart valve stent.

[0245] Specifically, in one embodiment, the first support structure 111 and the second support structure 112 may be formed by weaving the same braiding wire, and both may be formed in a continuous manner. For the sake of explanation, we will refer to them as the first support structure 111 and the second support structure 112. In addition, the support unit 110 and multiple support units 110 may also be formed by weaving the same braiding wire.

[0246] For example, there are three support units 110, and these three support units 110 form the support body 100.

[0247] As shown in Figures 1 and 2, in some embodiments, if we define the upstream and downstream directions along the direction in which blood flows through the passage 120, the second support structure 112 is located upstream of the two first support structures 111.

[0248] In the above embodiment, the second support structure 112 is located upstream of the two first support structures 111, that is, a blood inflow end is formed in the direction of the second support structure 112, and a blood outflow end is formed in the direction of the two first support structures 111, so that blood flows in from the direction of the second support structure 112 and flows out from the direction of the first support structures 111.

[0249] As shown in Figures 1 and 2, in some embodiments, the two first support structures 111 each extend downstream from both ends of the second support structure 112, and the two first support structures 111 merge and connect.

[0250] In the above embodiment, the first ends of the two first support structures 111 are connected to both ends of the second support structure 112, respectively, and the second ends extend downstream of the flow passage 120, where they merge and connect, thereby forming a closed space between the first support structures 111 and the second support structure 112 that can be covered by connecting a cover member. The second ends of the two first support structures 111 can be connected by riveting or welding.

[0251] As shown in Figures 1 and 2, in some embodiments, each support unit 110 is connected to a protruding extension branch structure 200, and the protruding extension branch structure 200 is located between two adjacent support units 110 in the circumferential direction of the support body 100.

[0252] In the above embodiment, there are multiple protruding extension branch structures 200, and each support unit 110 is connected to a protruding extension branch structure 200. Specifically, the multiple protruding extension branch structures 200 are installed at intervals and located between two adjacent support units 110 in the circumferential direction of the support body 100. In this way, when the protruding extension portions 210 of the multiple protruding extension branch structures 200 come into contact with cardiac tissue (e.g., the sinus of Valsalva), the reliability and stability of the (artificial) heart valve stent 10 after installation can be effectively improved.

[0253] Specifically, in one embodiment, the protruding extension branch structure 200 and the support unit 110 are formed by weaving together the same braided wire and are formed in a continuous manner.

[0254] As shown in Figures 1 and 2, in some embodiments, each support unit 110 is connected to two protruding extension branch structures 200, and the two protruding extension branch structures 200 between two adjacent support units 110 are connected to each other.

[0255] In the above embodiment, the ends of the two protruding extension branch structures 200 located upstream of the flow passage 120 between two adjacent support units 110 are connected, that is, the two protruding extension portions 210 of the two protruding extension branch structures 200 are connected to each other, thereby contributing to improved reliability and stability when the protruding extension portions 210 come into contact with cardiac tissue.

[0256] As shown in Figures 1 and 2, in some embodiments, two protruding extension branch structures 200 between two adjacent support units 110 are formed by a single braided wire.

[0257] In the above embodiment, the two protruding extension branch structures 200 between two adjacent support units 110 are integrally formed by a single braided wire, eliminating the need for further connections such as welding or riveting, and contributing to improved production efficiency of the product.

[0258] As shown in Figures 1 and 2, in some embodiments, a connecting ring 400 is formed downstream of the first support structure 111.

[0259] In the above embodiment, a connecting ring 400 is formed on the first support structure 111, and the connecting ring 400 is located downstream of the flow passage 120 and is connected to the transport system for the (artificial) heart valve stent 10, enabling the transport system to deliver and retrieve the heart valve stent.

[0260] As shown in Figures 1 and 2, in some embodiments, a connecting ring 400 is formed on each of the first support structures 111.

[0261] In the above embodiment, if there are multiple connecting rings 400, and all of the multiple connecting rings 400 are located downstream of the flow passage 120, and the multiple connecting rings 400 are connected to the transport system for the (artificial) heart valve stent 10, it can contribute to improving the reliability of the delivery of the (artificial) heart valve stent 10.

[0262] As shown in Figures 1 and 2, in some embodiments, a first rivet knot structure 114 is provided upstream of the connecting ring 400, and the first rivet knot structure 114 forms the connecting ring 400 as a closed ring.

[0263] In the above embodiment, by installing the first rivet knotting structure 114 upstream of the connecting ring 400, the connecting ring 400 is formed as a closed ring structure, which contributes to the connection between the connecting member of the conveying system and the connecting ring 400, and can contribute to improving the reliability of the connection between the connecting member of the conveying system and the connecting ring 400.

[0264] As shown in Figures 1 and 2, in some embodiments, each support unit 110 and its adjacent support unit 110 are connected by a rivet structure to form a second rivet knot structure 115, in which the first support structure 111 and the second support structure 112 of two adjacent support units 110 are arranged in parallel, and a gap 300 for accommodating the heart's own valve leaflets is formed between the protruding extension branch structure 200 and the first support structure 111 and the second support structure 112 in the second rivet knot structure 115.

[0265] In the above embodiment, each support unit 110 and two adjacent support units 110 are connected by a rivet structure, that is, the connection points between the two first support structures 111 and the second support structure 112 of each support unit 110, and the connection points between the two first support structures 111 and the second support structure 112 of the adjacent support unit 110 are connected by a rivet structure to form a second rivet knot structure 115. In the first rivet knot structure 114, the first support structures 111 and the second support structures 112 of two adjacent support units 110 are arranged in parallel, which contributes to improving the reliability of the connection of each support unit 110, improving the aesthetic appearance of the product, and the first support structures 111 and the second support structures 112 in the protruding extension branch structure and the second rivet knot structure 115 are installed with a gap between them, defining a gap for accommodating the heart's own valve leaflets.

[0266] As shown in Figures 1 and 2, in some embodiments, the two first support structures 111 of each support unit 110 are connected by a rivet structure to form a third rivet connection structure 116.

[0267] In the above embodiment, the connection points between the two first support structures 111 of each support unit 110, located downstream of the flow passage 120, are connected by a rivet structure such as a rivet pipe to form a third rivet connection structure 116. This effectively ensures a secure connection between the ends of the two first support structures 111 of each support unit 110, located downstream of the flow passage 120.

[0268] As shown in Figures 1 to 3, in some embodiments, along the direction in which blood flows through the flow passage 120, the protruding extension branch structure 200 includes a continuous protruding extension segment 220 and a connecting segment 230, the protruding extension segment 220 being bent and extended in a direction away from the flow passage 120, the connecting segment 230 being connected at one end to the protruding extension segment 220 and at the other end to the support body 100, and the angle between the protruding extension segment 220 and the axial direction of the flow passage 120 being 1° to 150°.

[0269] In the above embodiment, the protruding extension segment 220 is located downstream of the flow passage 120, and one end of the connecting segment 230 is connected to the protruding extension segment 220, and the other end extends in the downstream direction of the flow passage 120 and is connected to the first support structure 111 of the support body 100. By setting the angle formed by the protruding extension segment 220 and the axial direction of the flow passage 120 to be 1° to 15°, it contributes to the protruding extension segment 220 abutting against the heart tissue corresponding to the position of the heart tissue (for example, the sinus of Valsalva), and can contribute to improving the stability when the protruding extension segment 220 abuts against the heart tissue.

[0270] Specifically, a mounting space for passing through when mounting a medical device such as a coronary stent is defined between the connecting segment 230 and the first support structure 111.

[0271] As shown in FIGS. 1 to 3, in some embodiments, the horizontal distance a between the end of the connecting segment 230 connected to the protruding extension segment 220 and the support body 100 located upstream of the flow passage 120 is 1 mm to 20 mm.

[0272] In the above embodiment, by setting the distance a between the end of the connecting segment 230 connected to the protruding extension segment 220 and the support body 100 located upstream of the flow passage 120 to be 1 mm to 20 mm, on the one hand, it ensures that the protruding extension segment 220 can abut against the heart tissue, and on the other hand, after the self-valve leaflet of the heart abuts against the side close to the support body 10 of the protruding extension segment 220, it is accommodated in the gap between the protruding extension branch structure 200 and the support body 100, and the self-valve leaflet of the heart can be easily accommodated in the gap.

[0273] In some embodiments, the heart valve stent is formed by braiding with at least one elongated material.

[0274] In the above embodiment, illustratively, the elongated material is a shape memory alloy wire or a nickel-titanium alloy wire, etc. When the (artificial) heart valve stent 10 is woven by one elongated material, its integrity is relatively high and it can contribute to the processing and shaping. When the heart valve stent is woven by a plurality of elongated materials, two connected elongated materials can be fixedly connected by connection with a rivet tube or welding. Also, the connection points of two connected elongated materials can be fixedly connected by welding or screw connection.

[0275] In some embodiments, the elongated material includes a shape memory alloy wire.

[0276] In the above embodiment, the (artificial) heart valve stent 10 is woven by at least one shape memory alloy wire. The shape memory alloy wire can be deformed when subjected to an external force and can return to its original shape when the external force is released. After deforming the shape memory alloy wire with an external force, the artificial valve stent can be easily fed into the conveying system by the conveying system. After the artificial valve stent is fed to the location of the original aortic valve, the shape memory alloy wire quickly returns to its original shape, thereby improving the reliability that the heart valve stent is arranged and attached to the location of the aortic valve. When the (artificial) heart valve stent 10 is woven by a plurality of shape memory alloy wires, two connected shape memory alloy wires can be fixedly connected by connection with a rivet tube or welding. Also, the (artificial) heart valve stent 10 can be fixedly connected by welding or screw connection.

[0277] FIG. 4 is a schematic partial configuration diagram of a second support structure 112 according to an embodiment of the present disclosure. In some embodiments, the second support structure 112 is woven by at least one shape memory alloy wire with a diameter change.

[0278] FIG. 5 is a schematic partial configuration diagram of a second support structure 112 according to another embodiment of the present disclosure. In some embodiments, a shape memory alloy tube 500 is annularly installed on a part of the outer periphery of the second support structure 112.

[0279] In the above embodiment, the second support structure 112 is made by weaving together diameter-changing shape memory alloy wires, or a shape memory alloy tube 500 is fitted around a part of the outer circumference of the second support structure 112. By increasing the diameter of a part of the second support structure 112, the supporting force of the support by the heart valve stent can be increased, and the stability of the support can be improved.

[0280] As shown in Figure 6, in the second phase, embodiments of the present disclosure provide an artificial heart valve. The artificial heart valve includes one (artificial) heart valve stent 10 according to the embodiments of the first phase, a valve leaflet 20 provided in a flow passage 120 and connected to a first support structure 111 of the (artificial) heart valve stent 10, a first sealing cover member 30 configured to cover the space formed between the two first support structures 111 and the second support structure 112 of the (artificial) heart valve stent 10 by connection, and a second sealing cover member 40 installed to surround the outer circumference of the (artificial) heart valve stent 10.

[0281] In the above embodiment, the valve leaflets 20 are located within the flow passage 120 and connected to the first support structure 111 of the heart valve stent, allowing control of blood flow by opening and closing the valve leaflets 20. For example, when the heart contracts, the valve leaflets 20 open to send blood from the heart to the rest of the body via the aorta, and when the heart relaxes, the valve leaflets 20 close in a timely manner to prevent blood from returning from the aorta to the ventricles. A first sealing cover member 30 is installed in the space formed between the two first support structures 111 and the second support structure 112 of each support unit 110 of the heart valve stent, thereby preventing blood from flowing on the outer periphery of the heart valve stent and ensuring that blood flows in from the blood inlet end and out from the blood outlet end. A second sealing cover member 40 is installed to surround the outer periphery of the (artificial) heart valve stent 10 and is configured to prevent backflow of blood and prevent perivalvular backflow.

[0282] As shown in Figure 6, in some embodiments, the second sealing cover member 40 is disc-shaped, and the outer peripheral edge of the second sealing cover member 40 is bent downstream of the heart valve stent to form a protruding edge.

[0283] As shown in Figures 7 to 9, Figure 7 is a schematic diagram of a cardiac valve stent 10 according to some embodiments of the present disclosure, Figure 8 is a schematic diagram of a cardiac valve stent 10 according to some embodiments of the present disclosure viewed from another angle, and Figure 9 is a schematic enlarged view of location A in Figure 8. A first aspect embodiment of the present disclosure provides a cardiac valve stent 10. The cardiac valve stent 10 is made by weaving at least one elongated material into a defined shape, and a flow passage 120 through which blood flows is defined in the cardiac valve stent 10, and at least one elongated material extends outward from the flow passage 120 to form a protruding extension portion 210 that can contact cardiac tissue.

[0284] The heart valve stent 10 according to the embodiments of this disclosure is positioned in the location of the original aortic valve. The heart valve stent 10 is made by weaving together at least one elongated material into a defined shape, and a blood flow passage 120 is defined in the middle of the heart valve stent 10. Exemplarily, the elongated material is the shape memory alloy wire or the nickel-titanium alloy wire. At least one elongated portion of the material extends outward, projecting away from the flow passage 120, thereby forming a protruding extension 210 that can contact cardiac tissue (e.g., the sinus of Valsalva). When the heart valve stent 10 is positioned in the original aortic valve location, the protruding extension 210 contacts the cardiac tissue, securing the heart valve stent 10 and preventing displacement of the heart valve stent 10 under the pressure of blood on the valve leaflets 20 when the leaflets 20 close. This improves the stability and reliability of the placement of the heart valve stent 10 in the original aortic valve location, extends the service life of the heart valve stent 10, and contributes to improved stability of the heart valve stent 10 when used in patients without calcification.

[0285] As shown in Figures 7 and 8, in some embodiments, the heart valve stent 10 includes a plurality of support units 110, which define and form a flow passage 120, each support unit 110 including two first support structures 111 for connecting to different valve leaflets 20, and a second support structure 112 connected to the two first support structures 111, with a space formed between the two first support structures 111 and the second support structure 112 that can be covered by connecting a cover member.

[0286] For example, the number of support units is three.

[0287] As shown in Figures 7 and 8, in some embodiments, if we define the upstream and downstream directions along the direction in which blood flows through the passage 120, the second support structure 112 is located upstream of the two first support structures 111.

[0288] In the above embodiment, the second support structure 112 is located upstream of the two first support structures 111, that is, a blood inflow end is formed in the direction of the second support structure 112, and a blood outflow end is formed in the direction of the two first support structures 111, so that blood flows in from the direction of the second support structure 112 and flows out from the direction of the first support structures 111.

[0289] As shown in Figures 7 and 8, in some embodiments, the two first support structures 111 each extend downstream from both ends of the second support structure 112, and the two first support structures 111 are connected at their second ends.

[0290] In the above embodiment, the first ends of the two first support structures 111 are connected to both ends of the second support structure 112, respectively, and extend downstream of the flow passage 120. Furthermore, the second ends of the two first support structures 111 are connected to each other, thereby forming a closed space between them and the second support structure 112 that can be covered by connecting a cover member. The second ends of the two first support structures 111 are connected by methods such as riveting, welding, or bonding. In addition, the two first support structures 111 and the second support structure 112 can be connected integrally, that is, they are different parts of the same elongated material woven into a defined shape.

[0291] As shown in Figures 7 and 8, in some embodiments, each support unit 110 further includes a third support structure 113, the third support structure 113 forming a connecting ring 400 located downstream of the heart valve stent 10.

[0292] In the above embodiment, the support unit 110 further includes a third support structure 113, which forms a connecting ring 400 located downstream of the heart valve stent 10. The connecting ring 400 is connected to a transport system for the heart valve stent 10, enabling the transport system to deliver and retrieve the heart valve stent 10.

[0293] Each support unit 110 has two third support structures 113, and the ends of each of the two third support structures 113 located downstream of the heart valve stent 10 are connected to the second ends of the two first support structures 111, respectively, after forming a connecting ring 400. The connection here may include mechanical connections such as welding, bonding, or riveting, and both may represent extensions of the same object, that is, both belong to the same structure and represent different parts with different names.

[0294] As shown in FIGS. 7 and 8, in some embodiments, the end of the third support structure 113 located downstream of the heart valve stent 10 forms a connection ring 400 and is then connected to the first support structure 111, and the other end located upstream of the heart valve stent 10 forms a protruding extension 210 that can abut against the heart tissue. The third support structure 113 and the first support structure 111 may be integrally connected, or may be fixedly connected by riveting or welding.

[0295] As shown in FIGS. 7 and 8, in some embodiments, each support unit 110 has two third support structures 113. One end of each of the two third support structures 113 is connected to each of the two first support structures 111, and the other end of each of the two third support structures 113 forms a protruding extension 210 respectively.

[0296] In the above embodiments, each support unit 110 includes two third support structures 113. The two third support structures 113 are respectively located on both sides of the two first support structures 111. The first ends of the two third support structures 113 are respectively connected to the ends of the two first support structures 111 located downstream of the flow passage 120, and the other ends form protruding extensions 210 that can respectively abut against the heart tissue.

[0297] As shown in FIGS. 7 and 10, in some embodiments, one connection ring 400 is respectively formed at the most downstream location of each third support structure 113.

[0298] In the above embodiments, one connection ring 400 is respectively formed at the most downstream location of each third support structure 113. The connection rings 400 are all located on the most downstream side of the flow passage 120 and are connected to the connection structure of the conveying system, so that the heart valve stent can be fed into the heart tissue by the feeding mechanism, and the feeding stability and reliability can be improved.

[0299] As shown in Figures 7 and 8, in some embodiments, the protruding extension portion 210 of each support unit 110 and the protruding extension portion 210 of the adjacent support unit 110 are formed by bending the same elongated material, and two adjacent protruding extension portions 210 are formed continuously with each other.

[0300] In the above embodiment, the two adjacent protruding extensions 210 in the two adjacent support units 110 are continuous, formed by bending the same elongated material. This prevents damage to cardiac tissue from the protruding extensions 210 due to stress concentration, and further improves the support strength of the protruding extensions 210, thereby improving the reliability of the cardiac valve stent installation.

[0301] As shown in Figures 7 and 8, in some embodiments, each support unit 110 and its adjacent support unit 110 are connected by a rivet structure to form a first rivet knot structure 114, in which each elongated material is arranged in parallel and the protruding extension portion 210 is located in the middle.

[0302] In the above embodiment, each support unit 110 and two adjacent support units 110 are connected by a rivet structure, that is, the connection points between the two first support structures 111 and the second support structure 112 of each support unit 110, and the connection points between the two first support structures 111 and the second support structure 112 of the adjacent support unit 110 are connected by a rivet structure to form two first rivet knot structures 114, and the third support structure 113 is also connected to the first rivet knot structures 114. In the first rivet knot structures 114, each elongated material is arranged in parallel, which contributes to improving the reliability of the connection of each support unit 110, improving the aesthetic appearance of the product, contributing to the contraction and expansion of the heart valve stent 10, and the protruding extension portion 210 of each support unit 110 is located in the middle of the support unit 110, which contributes to contact with cardiac tissue.

[0303] As shown in Figures 7 and 8, in some embodiments, the two first support structures 111 of each support unit 110 are connected by a rivet structure to form a second rivet-connected structure 115, and the third support structure 113 is also connected to the second rivet-connected structure 115.

[0304] In the above embodiment, the connection points between the two first support structures 111 of each support unit 110, located downstream of the flow passage 120, are connected by a rivet structure such as a rivet pipe to form a second rivet connection structure 115. The two third support structures 113 of each support unit 110 are also connected to the second rivet connection structure 115, effectively ensuring a reliable connection between the two first support structures 111 and the two third support structures 113 in each support unit 110.

[0305] A rivet connection according to any one of the above embodiments involves binding multiple members with a single binding member (generally a metal member).

[0306] As shown in Figure 9, in some embodiments, the angle formed between the plane on which the protruding extension portion 210 is located and the direction perpendicular to the axial direction of the flow passage 120 is between 15° and 90°.

[0307] In the above embodiment, by setting the angle of the angle formed between the plane on which the protruding extension portion 210 is located and the direction perpendicular to the axial direction of the flow passage 12 to 15° to 90°, when the cardiac valve stent 10 is positioned in the original aortic valve position, the protruding extension portion 210 contributes to contacting the cardiac tissue in accordance with the position of the cardiac tissue, thereby contributing to improved stability of contact between the protruding extension portion 210 and the cardiac tissue.

[0308] As shown in Figure 9, in some embodiments, along the direction in which blood flows through the flow passage 120, the third support structure 113 includes a continuous protruding extension segment 220, a transition segment 240, and a connecting segment 230, wherein the protruding extension segment 220 forms a protruding extension portion 210, the transition segment 240 has one end connected to the protruding extension segment and the other end bent and extended in a direction away from the flow passage 120, with an angle of 60° to 150° between the angle formed between the transition segment 240 and the direction perpendicular to the axial direction of the flow passage 120, and the connecting segment 230 has one end connected to the transition segment 240 and the other end connected to the first support structure 111.

[0309] In the above embodiment, the third support structure 113 includes 10131 connected sequentially along the flow direction of the flow passage 120, a transition segment 240, and a connecting segment 230. The protruding extension segment 220 protrudes and extends outward from the flow passage 120 to form a protruding extension portion 210 that can contact cardiac tissue. The transition segment 240 has one end connected to the protruding extension segment 220 and the other end bent and extends away from the flow passage 120, with the angle of the transition segment 240 between the direction perpendicular to the axial direction of the flow passage 120 being 60° to 150°. This allows the cardiac valve stent 100 to widen the original aortic valve area and ensure normal blood flow. The connecting segment 230 has one end connected to the transition segment 240, and the other end bends and extends toward the first support structure 111 to form a connecting ring 400 at the downstream end of the flow passage 120, after which it is connected to the first support structure 111. This creates a relatively large space between the third support structure 113 and the valve leaflet 20, which can be used to attach the coronary artery stent when performing coronary artery stent placement surgery on a patient.

[0310] For example, the protruding extension segment 220, transition segment 240, and connecting segment 230 of the third support structure 113 are integrally connected, that is, they are made by weaving the same elongated material into a defined shape.

[0311] Referring to Figures 6 and 10, Figure 10 is a schematic diagram of an artificial heart valve 100 according to some embodiments of the present disclosure. In addition to the structure of the artificial heart valve 100 shown in Figure 6, the second sealing cover member 40 is installed so as to surround the outer circumference of the first sealing cover member 30 and is sealed and connected to the first sealing cover member 30.

[0312] In the above embodiment, the valve leaflets 20 are located within the flow passage 120 and connected to the heart valve stent 10, and the opening and closing of the valve leaflets 20 can control blood flow. For example, when the heart contracts, the valve leaflets 20 open to send blood from the heart to the rest of the body via the aorta, and when the heart relaxes, the valve leaflets 20 close in a timely manner to prevent blood from returning from the aorta to the ventricles. A first sealing cover member 30 is installed in the space formed between the two first support structures 111 and the second support structure 112 of each support unit 110 of the heart valve stent 10, thereby preventing blood from flowing on the outer periphery of the heart valve stent 10 and ensuring that blood flows in from the blood inlet end and out from the blood outlet end. A second sealing cover member 40 is further installed surrounding the outer periphery of the first sealing cover member 30 and is sealed and connected to the first sealing cover member 30, and the second sealing cover member 40 prevents backflow of blood and prevents circumvalvular backflow.

[0313] As shown in Figure 10, in some embodiments, the second sealing cover member 40 is disc-shaped, and the outer peripheral edge of the second sealing cover member 40 is bent downstream of the heart valve stent to form a protruding edge.

[0314] As shown in Figures 11, 12, and 16, a first aspect embodiment of the present disclosure provides an implantable cardiac valve stent 10. The implantable cardiac valve stent 10 includes a plurality of support units 110, which define and form a flow passage 120 through which blood flows, and at least one support unit 110 includes a protruding extension branch structure 200, the protruding extension branch structure 200 protruding and extending in a direction away from the flow passage 120 to form a protruding extension portion 210 that can contact cardiac tissue, and the protruding extension branch structure 200 extending upstream of the flow passage 120 to form a connecting structure 250 that can be connected to a cover member.

[0315] In the above embodiment, the implantable heart valve stent 10 includes a plurality of support units 110, which are connected to each other to define and form a flow passage 120 through which blood flows. At least one support unit 110 includes a protruding extension branch structure 200, which protrudes and extends in a direction away from the flow passage 120 to form a protruding extension portion 210 that can contact cardiac tissue. This allows the protruding extension portion 210 to contact cardiac tissue when the heart valve stent is placed in the original aortic valve position, thereby fixing the heart valve stent in place and preventing displacement of the heart valve stent under the action of blood pressure on the valve leaflets 20 when the leaflets 20 close. This improves the stability and reliability of the placement of the heart valve stent in the original aortic valve position and extends the service life of the heart valve stent. Furthermore, the protruding extension portion 210 extends upstream of the flow passage 120 to form a connecting structure 250 that can be connected to the sealing cover member. After the sealing cover member and the connecting structure 250 are connected, it is possible to prevent blood from flowing on the outer circumference of the flow passage 120, thereby improving the fluidity of blood when it flows along the axial direction of the flow passage 120.

[0316] Specifically, in patients with relatively severe calcification of the valve leaflet 20, the protruding extension 210 directly contacts the calcified valve leaflet of the patient. Because the calcified valve leaflet 20 has relatively high hardness, the protruding extension 210 effectively provides support when it contacts the calcified valve leaflet 20, ensuring reliability and stability when the heart valve stent is placed in the original location of the heart valve.

[0317] Specifically, in one embodiment, the protruding extension branch structure 200 and the support unit 110 may be formed by weaving the same braided wire, and both are formed in a continuous manner. For the sake of explanation, we will refer to them as the protruding extension branch structure 200 and the support unit 110. Furthermore, each support unit 110 and multiple support units 110 may also be formed by weaving the same braided wire.

[0318] As shown in Figures 11 and 12, in some embodiments, each support unit 110 includes two first support structures 111 for connecting to different valve leaflets 20, and at least one connecting structure 250 for connecting to the two first support structures 111, with a first space 600-A formed between the two first support structures 111 and the connecting structure 250, which can be covered by connecting a cover member.

[0319] In the above embodiment, each support unit 110 includes two first support structures 111, and a first space 600-A is formed between the two first support structures 111 and the connecting structure 250, which can be covered by connecting a cover member. When this space is covered by connecting a cover member, blood can only flow through the flow passage 120, thereby preventing blood from flowing on the outer periphery of the heart valve stent.

[0320] As shown in Figures 11 and 12, in some embodiments, if we define an upstream and downstream direction along the direction in which blood flows through the flow passage 120, the connecting structure 250 is located upstream of the two first support structures 111 and is formed in continuity with the end of the protruding extension branch structure 200 located upstream of the flow passage 120.

[0321] In the above embodiment, the connecting structure 250 is located upstream of the two first support structures 111, that is, a blood inflow end is formed in the direction of the connecting structure 250, and a blood outflow end is formed in the direction of the two first support structures 111, so that blood flows in from the direction of the connecting structure 250 and flows out from the direction of the first support structures 111. The connecting structure 250 is formed in continuity with the end of the protruding extension branch structure 200 located upstream of the flow passage 120, and is formed as a connecting structure 250 that can be covered by connecting a cover member.

[0322] As shown in Figures 14 and 15, in some embodiments, the connection structure 250 includes at least one subconnection structure 251, the at least one subconnection structure 251 being installed overlapping with or spaced apart from the connection structure 250.

[0323] In the above embodiment, at least one sub-connection structure 251 is connected to the connection structure 250, and the at least one sub-connection structure 251 is installed overlapping or spaced apart from the connection structure 250, thereby increasing the support strength when the connection structure 250 is supported at the original heart valve site, and improving the stability when the heart valve stent is installed.

[0324] As shown in Figures 11 and 12, in some embodiments, the two first support structures 111 each extend downstream from both ends of the connecting structure 250, and the two first support structures 111 merge and connect.

[0325] In the above embodiment, the first ends of the two first support structures 111 are connected to both ends of the connecting structure 250, respectively, and the second ends extend downstream of the flow passage 120, where they merge and connect, thereby forming a closed space between the two first support structures 111 and the connecting structure 250 that can be covered by connecting a cover member.

[0326] For example, the connection method between the second ends of the two first support structures 111, and the connection method between the two first support structures 111 and the connecting structure 250, can be by riveting or welding.

[0327] As shown in Figures 11 and 12, in some embodiments, each support unit 110 includes a protruding extension branch structure 200, and the protruding extension branch structure 200 is located between two adjacent support units 110 in the circumferential direction of the flow passage 120.

[0328] In the above embodiment, there are multiple protruding extension branch structures 200, and each support unit 110 includes a protruding extension branch structure 200. Specifically, the multiple protruding extension branch structures 200 are installed at intervals and located between two adjacent support units 110 in the circumferential direction of the support body. In this way, the protruding extension portions 210 of the multiple protruding extension branch structures 200 come into contact with cardiac tissue (e.g., calcified valve leaflets), thereby effectively improving the reliability and stability of the cardiac valve stent after installation.

[0329] As shown in Figures 11 and 12, in some embodiments, each support unit 110 includes two protruding extension branch structures 200, and the connecting structures 250 formed by the two protruding extension branch structures 200 are connected to each other.

[0330] In the above embodiment, the connection structures 250 formed by the two protruding extension branch structures 200 of each support unit 110 are connected to each other (for example, by integral connection, welding, or riveting), which contributes to improved stability when covering the space formed between the connection structure 250 and the first support structure 111 by connecting the sealing cover member, contributes to improved product integrity, and improves reliability and stability when the heart valve stent is placed in the location of the original heart valve.

[0331] As shown in Figures 11 and 12, in some embodiments, a second space 600-B for passing medical equipment is formed between each protruding extension branch structure 200 and the first support structure 111.

[0332] In the above embodiment, a second space 600-B is formed between each protruding extension branch structure 200 and the first support structure 111 connected thereto, allowing medical devices such as coronary artery stents to pass through. This makes it possible to easily install medical devices such as coronary artery stents after the heart valve stents have been installed.

[0333] In some embodiments, the protruding extension branch structure 200 and the first support structure 111 are made by braiding together a single braided wire.

[0334] In the above embodiment, the protruding extension branch structure 200 and the first support structure 111 are made by braiding together a single braided wire, and since these two structures are formed in a continuous manner, further connections by methods such as welding or riveting are unnecessary, which can contribute to improving the production efficiency of the product and improving the overall integrity of the product.

[0335] As shown in Figures 11, 12, and 16, in some embodiments, the protruding extension branch structure 200 has a connecting ring 400 formed at the end located downstream of the flow passage 120.

[0336] In the above embodiment, a connecting ring 400 is installed on the protruding extension branch structure 200, and the connecting ring 400 is located downstream of the flow passage 120 and is connected to the transport system for the implantable heart valve stent 10, enabling the transport system to deliver and retrieve the heart valve stent.

[0337] As shown in Figures 11 and 12, in some embodiments, each support unit 110 and its adjacent support unit 110 are connected by a rivet structure to form a first rivet knot structure 114, in which the first support structures 111 and connecting structures 250 of two adjacent support units 110 are arranged in parallel, and the end of the protruding extension branch structure 200 located upstream of the flow passage 120 is located in the first rivet knot structure 114.

[0338] In the above embodiment, each support unit 110 and two adjacent support units 110 are connected by a rivet structure, that is, the connection points between the two first support structures 111 of each support unit 110 and the connecting structure 250, and the connection points between the two first support structures 111 of the adjacent support unit 110 and the connecting structure 250 are connected by a rivet structure to form a first rivet knot structure 114. In the first rivet knot structure 114, the first support structures 111 of two adjacent support units 110 and the connecting structure 250 are arranged in parallel, which contributes to improving the reliability of the connection of each support unit 110, improving the aesthetic appearance of the product, and the end of the protruding extension branch structure 200 located upstream of the flow passage 120 is also located in the second rivet knot structure 115 and is formed continuously with the connecting structure 250.

[0339] As shown in Figures 11 and 12, in some embodiments, the two first support structures 111 of each support unit 110 are connected by a rivet structure to form a second rivet-connected structure 115.

[0340] In the above embodiment, the connection points between the two first support structures 111 of each support unit 110, located downstream of the flow passage 120, are connected by a rivet structure such as a rivet pipe to form a second rivet connection structure 115. This effectively ensures a secure connection between the ends of the two first support structures 111 of each support unit 110, located downstream of the flow passage 120.

[0341] As shown in Figures 11, 12, and 13, in some embodiments, the projecting extension branch structure 200 includes a first connecting segment, a contact segment, and a second connecting segment, which are connected in sequence, the first connecting segment being connected to a first riveted structure 114, the contact segment having its first end connected to the first connecting segment and its second end projecting outwards from the flow passage 120, and the second connecting segment having one end connected to the second end of the contact segment and the other end connected to a first support structure 111.

[0342] In the above embodiment, the protruding extension branch structure 200 includes a first connecting segment, a contact segment, and a second connecting segment, which are connected in sequence, with at least a portion of the first connecting segment located in the first riveted knotting structure 114 and formed continuously with the connecting structure 250. The contact segment has a first end connected to the first connecting segment, and its second end protrudes outward from the flow passage 120 to form a protruding extension portion 210 that can contact cardiac tissue. The second connecting segment has one end connected to the contact segment, and its other end extends in a direction closer to the flow passage 120 and is connected to the first support structure 111.

[0343] As shown in Figure 13, in some embodiments, the angle α between the contact segment and the axial direction of the flow passage 120 is 10° to 150°.

[0344] In the above embodiment, by setting the angle α between the contact segment and the axial direction of the flow passage 120 to 10° to 150°, it is possible to contribute to the contact segment coming into contact with cardiac tissue (for example, calcified valve leaflets) and to improve the stability of the contact segment when it comes into contact with cardiac tissue.

[0345] As shown in Figure 13, in some embodiments, the distance b between the second end of the contact segment and the first connecting segment is 1 mm to 20 mm.

[0346] In the above embodiment, the first connecting segment is connected to the first riveted structure 114 along the axial direction of the flow passage 120. By setting the distance b between the second end of the contact segment and the first connecting segment to 1 mm to 20 mm, it is possible to ensure that the contact segment contacts the cardiac tissue, while preventing the contact segment from excessively protruding outward from the flow passage 120 and damaging the cardiac tissue.

[0347] In some embodiments, the implantable heart valve stent 10 is made by braiding at least one braided wire.

[0348] In the embodiments described above, the braided wire is, for example, a shape memory alloy wire or a nickel-titanium alloy wire. When the heart valve stent is made by braiding a single braided wire, the integrity of the heart valve stent is relatively high, which can contribute to processing and molding. When the heart valve stent is made by braiding multiple elongated materials, the two elongated materials to be connected can be fixedly connected by rivet tubes or welding. In addition, the connection point of the two elongated materials to be connected can be fixedly connected by welding or screw connections.

[0349] In some embodiments, the braided wire includes a shape memory alloy wire.

[0350] In the above embodiment, the heart valve stent is made by braiding at least one shape memory alloy wire, and the shape memory alloy wire is deformable when subjected to an external force and can return to its original shape when the external force is released. After the shape memory alloy wire is deformed by an external force, the implantable heart valve stent 10 is easily delivered by the transport system, and after the artificial valve stent is delivered to the original aortic valve site, the shape memory alloy wire quickly returns to its original shape, thereby improving the reliability of positioning and attaching the heart valve stent to the aortic valve site.

[0351] In some embodiments, the connecting structure 250 is made by weaving together diameter-variable shape memory alloy wires, or a shape memory alloy tube is fitted around a portion of the outer circumference of the connecting structure 250.

[0352] In the above embodiment, the connecting structure 250 is made by weaving together diameter-changing shape memory alloy wires, or by encircling a part of the outer circumference of the connecting structure 250 with a shape memory alloy tube. By increasing the diameter of a part of the connecting structure 250, the supporting force of the support by the heart valve stent can be increased, and the stability of the support can be improved.

[0353] As shown in Figure 16, a second embodiment of the present disclosure provides a cardiac prosthesis. The cardiac prosthesis includes one implantable cardiac valve stent 10 according to the first embodiment, a valve leaflet 20 provided in a flow passage 120 and connected to a first support structure 111 of the implantable cardiac valve stent 10, a first sealing cover member 30 configured to cover the space formed between the two first support structures 111 and the connecting structure 250 of the cardiac valve stent by connection, and a second sealing cover member 40 installed to surround the outer periphery of the implantable cardiac valve stent 10.

[0354] In the above embodiment, the valve leaflets 20 are located within the flow passage 120 and connected to the first support structure 111 of the heart valve stent, allowing control of blood flow by opening and closing the valve leaflets 20. For example, when the heart contracts, the valve leaflets 20 open to send blood from the heart to the rest of the body via the aorta, and when the heart relaxes, the valve leaflets 20 close in a timely manner to prevent blood from returning from the aorta to the ventricles. A first sealing cover member 30 is installed in the space formed between the two first support structures 111 and the connecting structure 250 of each support unit 110 of the heart valve stent, thereby preventing blood from flowing on the outer periphery of the heart valve stent and ensuring that blood flows in from the blood inlet end and out from the blood outlet end. A second sealing cover member 40 is installed to surround the outer periphery of the heart valve stent 10 and is configured to prevent backflow of blood and prevent perivalvular backflow.

[0355] In some embodiments, the method of connecting the valve leaflet 20 to the first support structure 111 of the heart valve stent is one of adhesive, hot melt, or polymer adhesive.

[0356] In the above embodiment, the second sealing cover member 40 is disc-shaped, so that when the heart valve stent is positioned in the original aortic valve position, the second sealing cover member 40 abuts against the original heart valve tissue, and the outer peripheral edge of the second sealing cover member 40 bends downstream of the heart valve stent to form a protruding edge. In this way, when the valve leaflets 20 close, blood can only flow from the valve leaflets 20 upwards above the second sealing cover member 40, flowing above the second sealing cover member 40, effectively preventing backflow of blood and preventing circumvalvular backflow.

[0357] In some embodiments, the material of the valve leaflet 20 is one of polymer materials, biomaterials, and tissue engineering materials.

[0358] In the embodiments described above, the material of the valve leaflet 20 is, for example, bovine pericardium, porcine pericardium, bovine / porcine heart valve material, etc.

[0359] In some embodiments, the method of connecting the valve leaflet 20 to the first support structure 111 of the (artificial) heart valve stent 10 is one of adhesive, hot melt, or polymer adhesive.

[0360] In the above embodiment, the valve leaflets 20 are fixedly connected to the first support structure 111 of the (artificial) heart valve stent 10 by one of the following methods: adhesive bonding, hot melt bonding, or polymer bonding. This prevents damage and detachment of the valve leaflets 20 due to stress concentration and contributes to improving the product's service life.

[0361] Referring to Figures 17 to 19, Figure 17 is a schematic perspective view of a heart valve stent according to an embodiment of the present disclosure, Figure 18 is a schematic perspective view of a heart valve stent from another angle according to an embodiment of the present disclosure, and Figure 19 is a schematic perspective view of a heart valve stent, valve leaflets, and first cover member according to an embodiment of the present disclosure. The heart valve stent 10 includes a support body 100 and at least one protruding extension branch structure 200, the support body 100 includes a plurality of support units 110 which define and form a passage 101 through which blood flows, each support unit 110 includes two first support structures 111 for connecting to different valve leaflets 20, at least one support unit 110 includes a second support structure 112 which is provided on the side of the first support structure 111 closer to its adjacent support unit 110, the protruding extension branch structure 200 is fixed relative to two adjacent support units 110 and extends outward from the support body 100 to the outside of the passage 101, and a gap (not shown) is formed between the protruding extension branch structure 200 and the support body 100 to accommodate the heart's own valve leaflets.

[0362] By installing the first support structure 111 and the second support structure 112 to form the support body 100, the support body 100 has more support parts in the circumferential direction, the structure of the support body 100 becomes stronger, the passage 101 is less likely to deform, blood flows more smoothly through the passage 101 and blood flow velocity is not impaired. By installing the protruding extension branch structure 200 that abuts against cardiac tissue, the heart's own valve leaflets are housed between the protruding extension branch structure 200 and the support body 100, thereby making the heart valve stent 10 less likely to come loose after being implanted in the heart and making it stronger, extending the service life of the heart valve stent 10 and reducing the risk of the patient needing valve replacement again.

[0363] In some embodiments, the support body 100 includes three support units 110, and the three support units 110 form the support body 100. The support body 100 has a simple structure, is easy to manufacture, and has a relatively strong structure.

[0364] In other embodiments, the support body 100 may be composed of two or more support units 110, or more than two support units 110.

[0365] In some embodiments, each support unit 110 includes two second support structures 112, with the two second support structures 112 in each support unit 110 being provided on both sides of the two first support structures 111.

[0366] By installing two first support structures 111 and two second support structures 112 on either side of the two first support structures 111, the overall structure of the support body 100 can be made stronger.

[0367] In some embodiments, each support unit 110 includes a third support structure 113 connected to two first support structures 111, and a space is formed between the two first support structures 111 and the third support structure 113 that is covered by the connection of a first cover member 50.

[0368] By installing the third support structure 113, a space covered by the first cover member 50 is formed by the third support structure 113 and the first support structure 111, thereby preventing the backflow of blood.

[0369] In some embodiments, each first support structure 111 is fixed relative to one protruding extension branch structure 200, and each protruding extension branch structure 200 is fixedly connected relative to two adjacent first support structures 111 belonging to each of two adjacent support units 110, with the intermediate portion of the protruding extension branch structure 200 forming a protruding extension portion 210 for contact with cardiac tissue.

[0370] By connecting each protruding extension branch structure 200 to two adjacent first support structures 111, the two adjacent support units 110 are connected and fixed, making the overall structure of the support body 100 more stable. By forming a protruding extension portion 210 with the intermediate portion of the protruding extension branch structure 200, contact with cardiac tissue is achieved, allowing the cardiac valve stent 10 to be positioned more stably in the predetermined location of the heart.

[0371] In some embodiments, two adjacent second support structures 112, each belonging to one of two adjacent support units 110, are located along the circumferential direction of the heart valve stent 10 between projecting extension branch structures 200 that connect the two support units 110.

[0372] The two adjacent second support structures 112, each belonging to one of the two adjacent support units 110, are positioned along the circumferential direction of the heart valve stent 10 between the protruding extension branch structure 200 connecting the two support units 110. This allows the second support structures 112 to perform their support role more effectively, mitigating the problem of deformation caused by excessive spacing between the two adjacent first support structures 111 of the two adjacent support units 110, and making the structure of the heart valve stent 10 more robust.

[0373] In some embodiments, two adjacent second support structures 112, each belonging to one of two adjacent support units 110, are located inside a protruding extension branch structure 200 that connects the two support units 110 along the radial direction of the heart valve stent 10.

[0374] The two adjacent second support structures 112, each belonging to one of the two adjacent support units 110, are positioned along the radial direction of the heart valve stent 10, inside the protruding extension branch structure 200 that connects the two support units 110. This allows the second support structures 112 to perform their support role more effectively, making the structure of the heart valve stent 10 more robust. Furthermore, the formation of a gap between the protruding extension branch structure 200 and the support body 100 that accommodates the heart's own valve leaflets contributes to the protruding extension branch structure 200 contacting cardiac tissue, allowing the heart valve stent 10 to be positioned more stably in its predetermined location in the heart.

[0375] In some embodiments, the downstream portions of the two first support structures 111 of the support unit 110 and the downstream portions of the two protruding extension branch structures 200 are connected by a rivet structure to form a first rivet connection structure 114, and these two protruding extension branch structures 200 are two protruding extension branch structures 200 that are fixed relative to these two first support structures 112.

[0376] By connecting the first support structure 111 and the protruding extension branch structure 200 with a rivet structure, the structures of the first support structure 111 and the protruding extension branch structure 200 become less prone to deformation and stronger, thereby making the overall structure of the heart valve stent 10 stronger.

[0377] In some embodiments, the upstream portions of two adjacent first support structures 111 belonging to each of two adjacent support units 110, the upstream portions of two adjacent second support structures 112, and the downstream portions of two adjacent third support structures 113 are connected by a rivet structure to form a third rivet-connected structure 115.

[0378] By connecting the first support structure 111, the second support structure 112, and the third support structure 113 with a rivet structure, the structures of the first support structure 111, the second support structure 112, and the third support structure 113 become less prone to deformation and more robust, thereby making the overall structure of the heart valve stent 10 more robust.

[0379] In some embodiments, each support unit 110 is formed by braiding one braided wire 131, and each protruding extension branch structure 200 is formed by another braided wire 131.

[0380] By forming one support unit 110 by braiding with one braided wire 131, the fabrication of the support unit 110 can be simplified, eliminating the need for other connecting structures and making the structure of the support unit 110 simpler and stronger. By forming the protruding extended branch structure 200 with another braided wire 131, the fabrication is made easier, and it contributes to creating a gap between the protruding extended branch structure 200 and the support body 100 to accommodate the heart's own valve leaflets, allowing the protruding extended branch structure 200 to come into contact with cardiac tissue.

[0381] In some embodiments, the braided wire 131 includes a diameter change section, the diameter of which is larger than the diameter of the rest of the wire, and the diameter change section is provided in correspondence with a rivet structure.

[0382] By providing a diameter change section of the braided wire 131 that corresponds to the rivet structure, it can contribute to the rivet connection of the braided wire 131, making it less likely for the braided wire 131 to slide within the rivet knot structure or to come loose from within the rivet knot structure, resulting in a stronger rivet connection.

[0383] Figure 20 is a schematic diagram of a braided wire for a heart valve stent according to an embodiment of the present disclosure. In some embodiments, the braided wire 131 is made of a diameter-changing shape memory alloy wire, thereby forming a diameter-changing portion 132.

[0384] By forming a diameter-changing section 132 using a diameter-changing shape memory alloy wire as a braided wire 131, when forming a support unit 110 or a protruding extension branch structure 200 by braiding with the diameter-changing shape memory alloy wire, the diameter-changing section directly corresponds to the rivet connection position, and the diameter-changing section 132 is further connected by a rivet connection member, thereby simplifying the installation process of the rivet structure.

[0385] Figure 21 is a schematic diagram of the braided wire of another heart valve stent according to an embodiment of the present disclosure. In the other embodiment, a shape memory alloy tube is mounted around the outer circumference of the braided wire 133, and the portion where the shape memory alloy tube is mounted is the diameter change portion 134.

[0386] By mounting a shape memory alloy tube around the outer circumference of the braided wire 133 to form a diameter change section 134, when braiding the support unit 110 or the protruding extension branch structure 200 with the braided wire 133, it is not necessary to consider the position of the diameter change section 134. After the support unit 110 or the protruding extension branch structure 200 has been braided, the shape memory alloy tube can be installed at the rivet connection points to form the diameter change section 134 for rivet connection, thereby simplifying the braiding process for the support unit 110.

[0387] As shown in Figures 17 to 19, in some embodiments, a connecting ring 400 is formed downstream of each support unit 110.

[0388] By forming the connecting ring 400 downstream of the support unit 110, the support unit 110 can be formed by weaving with a single braided wire 131, the connecting ring 400 is less prone to deformation, and therefore the first support structure 111 and the second support structure 112 are also less prone to deformation, making the structure of the support unit 110 more robust.

[0389] Referring to Figures 22 and 23, Figure 22 is a schematic perspective view of another heart valve stent according to an embodiment of the present disclosure, and Figure 23 is a schematic perspective view of another heart valve stent according to an embodiment of the present disclosure from a different angle. The heart valve stent 10 includes a support body 800 and at least one protruding extension branch structure 900, the configuration of the support body 800 is similar to the configuration of the support body 100 in the heart valve stent 10 described above, and is therefore omitted from this description.

[0390] This embodiment differs from the above embodiment in the following respects. Each second support structure 812 is fixed relative to one protruding extension branch structure 900, and the intermediate portion of the protruding extension branch structure 900 forms a protruding extension portion 910 for contact with cardiac tissue.

[0391] Each protruding extension branch structure 900 connects to one second support structure 812, thereby connecting and fixing two adjacent support units 810, making the overall structure of the support body 800 more stable. By forming a protruding extension portion 910 with the intermediate portion of the protruding extension branch structure 900, contact with cardiac tissue is achieved, allowing the cardiac valve stent 10 to be positioned more stably in the predetermined location of the heart.

[0392] In some embodiments, portions of two adjacent second support structures 812, each belonging to one of two adjacent support units 810, are located along the circumferential direction of the heart valve stent 10 between projecting extension branch structures 900 that connect to these two support units 810.

[0393] By positioning portions of two adjacent second support structures 812, each belonging to one of two adjacent support units 810, along the circumferential direction of the heart valve stent 10 between the protruding extension branch structures 900 that connect to these two support units 810, the second support structures 812 can better perform their support role, mitigating the problem of deformation caused by excessive spacing within the protruding extension branch structures 900, and making the structure of the heart valve stent 10 more robust.

[0394] In some embodiments, portions of two adjacent second support structures 812, each belonging to one of two adjacent support units 810, are located inside a projecting extension branch structure 900 that connects to these two support units 810 along the radial direction of the heart valve stent 10.

[0395] Because portions of two adjacent second support structures 812, each belonging to one of two adjacent support units 810, are located inside the protruding extension branch structure 900 that connects to these two support units 810, along the radial direction of the heart valve stent 10, the second support structures 812 can better perform their support role, making the structure of the heart valve stent 10 more robust. Furthermore, because a gap is formed between the protruding extension branch structure 900 and the support body 800 to accommodate the heart's own valve leaflets, the protruding extension branch structure 900 can come into contact with cardiac tissue, allowing the heart valve stent 10 to be positioned more stably in its predetermined location in the heart.

[0396] In some embodiments, the downstream portions of the two first support structures 811 of the support unit 810 are connected by a rivet structure to form a first rivet-connected structure 814, and the downstream portion of the protruding extension branch structure 900 and the second support structure 400 are connected by a rivet structure to form a second rivet-connected structure 815.

[0397] The rivet structure connects the two first support structures 811 of the support unit 810 and connects the protruding extension branch structure 900 and the second support structure 812, making the structures of the first support structure 811, the protruding extension branch structure 900 and the second support structure 812 less prone to deformation and more robust, thereby making the overall structure of the heart valve stent 10 more robust.

[0398] In some embodiments, the upstream portions of two adjacent first support structures 811 belonging to each of two adjacent support units 810, the upstream portions of two adjacent second support structures 812, and the downstream portions of two adjacent third support structures 813 are connected by a rivet structure to form a third riveted connection structure 816.

[0399] By connecting the first support structure 811, the second support structure 812, and the third support structure 813 with a rivet structure, the structures of the first support structure 811, the second support structure 812, and the third support structure 813 become less prone to deformation and stronger, thereby making the overall structure of the heart valve stent 10 stronger.

[0400] Referring to Figures 24 and 19, Figure 24 is a schematic diagram of an artificial heart valve according to an embodiment of the present disclosure. The artificial heart valve includes a heart valve stent 10, a valve leaflet 20 provided in a passage 101 and connected to a first support structure 111 of the heart valve stent 10, and a first cover member 50 configured to cover, by connection, the space formed between the two first support structures 111 and the third support structure 113 of the support unit 110 of the heart valve stent 10.

[0401] By installing the first support structure 111 and the second support structure 112 to form the support body 100, the structure of the support body 100 becomes stronger, the passage 101 is less likely to deform, and by installing the protruding extension branch structure 200 that contacts cardiac tissue, the cardiac valve stent 10 becomes more secure and less likely to come loose after being implanted in the heart, extending the service life of the cardiac valve stent 10 and reducing the risk of the patient needing valve replacement. By installing the valve leaflets 20 and the first cover member 50, blood flows from upstream to downstream of the support body 100, preventing backflow.

[0402] Figure 25 is a schematic perspective view of a second cover member in an artificial heart valve according to an embodiment of the present disclosure. In some embodiments, the artificial heart valve further includes a second cover member 60, which is installed to surround the outer circumference of the heart valve stent 10, with the upstream end of the second cover member 60 connected to the first cover member 50, and the circumference of the second cover member 60 gradually increases and then gradually decreases from the upstream end to the downstream end.

[0403] By installing the second cover member 60 on the outer circumference of the heart valve stent 10, the second cover member 60 comes into contact with the cardiac tissue, further preventing blood reflux. Furthermore, by having the circumference of the second cover member 60 gradually increase from the upstream end to the downstream end and then gradually decrease, the middle portion of the outer circumference of the second cover member 60 comes into contact with the cardiac tissue, resulting in a better effect in preventing blood reflux.

[0404] In some embodiments, an annular first projection 601 is formed at the downstream end of the second cover member 60, and the first projection 601 is formed toward the downstream of the heart valve stent 10.

[0405] By installing the first protruding edge 601 at the downstream end of the second cover member 60, the effect of preventing blood backflow is improved.

[0406] In some embodiments, a housing notch 602 is formed in the first protruding edge 601 and the second cover member 60, and the housing notch 602 is configured to accommodate the support body 100.

[0407] By forming a housing notch 602 in the first protruding edge 601 and the second cover member 60 to accommodate the support body 100, the first protruding edge 601 and the second cover member 60 and the support body 100 can be brought into closer contact, preventing backflow of blood between the first protruding edge 601 and the second cover member 60 and the support body 100.

[0408] Figure 26 is a schematic perspective view of a second cover member in another prosthetic heart valve according to an embodiment of the present disclosure. In some embodiments, a first projection 701 is formed at the downstream end of the second cover member 70, a housing notch 702 is formed in the first projection 701 and the second cover member 70, and an annular second projection 703 is formed on the outer peripheral edge of the second cover member 70, with the second projection 703 being formed toward the downstream of the heart valve stent 10.

[0409] By installing the second protruding edge 703 on the outer peripheral edge of the second cover member 70, the second protruding edge 703 comes into contact with the cardiac tissue, resulting in a better effect in preventing the backflow of blood.

[0410] In some embodiments, the second protruding edge 703 is provided on the outermost edge of the second cover member 70, where the circumference is greatest.

[0411] By providing the second protruding edge 703 at the outermost edge of the second cover member 70, which has the largest circumference, the second protruding edge 703 can better contact the cardiac tissue, resulting in a better effect in preventing blood backflow.

[0412] In other embodiments, the second projection 703 may be provided between the downstream end of the second cover member 70 and the outermost edge of the second cover member 70 with the longest circumference.

[0413] In all embodiments of this disclosure, “large” and “small,” “many” and “few,” and “above” and “below” are relative terms. Further explanation of the expression of such relative terms is omitted in the embodiments of this disclosure.

[0414] The phrases “in this embodiment,” “in an embodiment of this disclosure,” or “in an optional embodiment” in the specification mean that certain features, structures, or characteristics relating to an embodiment are included in at least one embodiment of this disclosure. Therefore, “in this embodiment,” “in an embodiment of this disclosure,” or “in an optional embodiment” in the specification do not necessarily refer to the same embodiment. Furthermore, these specific features, structures, or characteristics can be combined in one or two embodiments in any suitable manner. It will be obvious to those skilled in the art that all embodiments described in the specification are optional embodiments, and that the operations and modules involved are not necessarily essential to this disclosure.

[0415] In various embodiments of this disclosure, the numbering of the steps described above does not limit the order of execution, as the order of execution of each step is determined by its function and inherent logic. Therefore, the numbering of the steps described above should be understood as not limiting the steps of implementation of the embodiments of this disclosure.

[0416] The foregoing are merely specific embodiments of the present disclosure, and the scope of protection of the present disclosure is not limited thereto. A person skilled in the art will know that any modification or substitution made within the scope of the art disclosed herein falls within the scope of protection of the present disclosure. Therefore, the scope of protection of the present disclosure is equivalent to the claims.

[0417] In this specification, relational terms such as "First" and "Second" are used solely to distinguish one entity or action from another, and do not necessarily imply or require any factual relationship or order between such entities or actions. Furthermore, terms such as "having" and "including," and any variations thereof, are intended to encompass non-exclusive inclusion. Thus, a process, method, article, or apparatus containing a set of elements is not necessarily limited to these elements and may include other elements not explicitly stated or specific to these processes, methods, articles, or apparatus. Unless otherwise specified, the expression "~including" does not exclude situations where the process, method, article, or apparatus containing such elements also has other similar elements.

[0418] Industrial applicability This disclosure belongs to the field of medical devices technology and provides (implantable) cardiac valve stents and cardiac prosthetic valves. According to the proposed technology of this disclosure, it is possible to improve the stability and reliability of the attachment and fixation of cardiac valve stents, extend the service life of cardiac valve stents, reduce the risk of re-replacement of the patient's valve, and contribute to reducing coronary artery blockage after cardiac valve stents have been used in patients. [Explanation of symbols]

[0419] 1. Artificial heart valve 10. Heart valve stent or (artificial) heart valve stent or implantable heart valve stent 100 Supporter 110 Support Unit 111 1st support structure 112 Second support structure 113 Third support structure 114 First rivet knot structure 115 Second rivet knot structure 116 Third rivet knot structure 120 Flow passage or passage 131 Braided Wire 132 Diameter change section 133 Braided Wire 134 Diameter change section 200 Protruding and extended branch structure 210 Protruding extension part 220 Protruding extended segment 230 connection segments 240 Transition Segments 250 connection structure 251 Subconnection Structure 300 void 400 connecting rings 500 shape memory alloy tube 600-A 1st space 600-B 2nd space 20 leaflets 30 First sealing cover member 40 Second sealing cover member 800 Supporter 810 Support Unit 811 1st support structure 812 Second support structure 813 Third support structure 814 First rivet knot structure 815 Second rivet knot structure 816 Third rivet knot structure 900 Protruding extended branch structure 910 Protruding extension part 20 leaflets 50 First cover member 60 Second cover member 601 First ridge 602 Retaining cutout 70 Second cover member 701 First ridge 702 Retaining cutout 703 Second ridge

Claims

1. The structure comprises a support body and at least one protruding extension branch structure connected to the support body, wherein a flow passage for blood is defined in the support body, the protruding extension branch structure extends from the support body outward from the flow passage, the protruding extension branch structure has a protruding extension portion that can contact cardiac tissue, and a gap is formed between the protruding extension branch structure and the support body for accommodating the heart's own valve leaflets. The support body includes a plurality of support units, and the flow passage is defined and formed by the plurality of support units. Each of the support units includes two first support structures for connecting to different valve leaflets, and a second support structure connected to the two first support structures, with a space formed between the two first support structures and the second support structure that can be covered by connecting a cover member. If we define the upstream and downstream directions along the direction in which blood flows through the flow passage, then the second support structure is located upstream of the two first support structures. The two first support structures each extend downstream from both ends of the second support structure, and the two first support structures merge and connect to each other. Each of the support units is connected to the protruding extension branch structure, and the protruding extension branch structure is located between two adjacent support units in the circumferential direction of the support body. Each of the support units is connected to two of the protruding extension branch structures, and the two protruding extension branch structures between two adjacent support units are connected to each other. A heart valve stent characterized by the following features.

2. Along the direction in which blood flows through the flow passage, the protruding extension branch structure includes a continuous protruding extension segment and a connecting segment, The protruding extended segment is bent and extended in a direction away from the flow passage, the connecting segment has one end connected to the protruding extended segment and the other end connected to the support body, and the angle formed between the protruding extended segment and the axial direction of the flow passage is between 1° and 150°. The horizontal distance (a) between the end of the connecting segment that connects to the protruding extension segment and the support body located upstream of the flow passage is 1 mm to 20 mm. The cardiac valve stent according to feature 1.

3. The two protruding extension branch structures between two adjacent support units are formed from a single braided wire. The cardiac valve stent according to feature 2.

4. A connecting ring is formed in the downstream portion of the first support structure. The cardiac valve stent according to feature 1.

5. The connecting ring is formed on each of the first support structures. The cardiac valve stent according to feature 4.

6. A first rivet knotting structure is provided upstream of the connecting ring, and the connecting ring is formed as a closed ring by the first rivet knotting structure. The cardiac valve stent according to feature 4.

7. Each of the support units and its adjacent support unit are connected by a rivet structure to form a second rivet knot structure, in which the first support structure and the second support structure of two adjacent support units are arranged in parallel, and the gap for accommodating the heart's own valve leaflets is formed between the protruding extension branch structure and the first support structure and the second support structure in the second rivet knot structure. The cardiac valve stent according to feature 1.

8. The two first support structures of each support unit are connected by a rivet structure to form a third rivet connection structure. The cardiac valve stent according to feature 1.

9. A cardiac valve stent according to claim 1, A valve leaflet provided within the flow passage and connected to the first support structure of the heart valve stent, The first sealing cover member is installed in and connected to the space formed between the two first support structures and the second support structure of the heart valve stent, and covers the space. An artificial heart valve characterized by the following features.

10. The system further includes a second sealing cover member that is installed to surround the outer circumference of the heart valve stent, The second sealing cover member is disc-shaped, and its outer peripheral edge is bent downstream of the heart valve stent to form a protruding edge. The artificial cardiac valve according to feature 9.

11. The material of the valve leaflet is at least one of polymer materials, biomaterials, and tissue engineering materials. The artificial cardiac valve according to feature 9.

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