Heart valve stent and heart prosthesis

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] The present 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 "Implanted 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, cause abnormal heart function, and ultimately lead to 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 falling out due to the influence of blood flow after implantation, and the stability of installation and fixation is relatively poor, which impairs the service life of artificial heart valves, increases the risk of re-replacing the patient's valves, and after some heart valve stents are installed, coronary artery blockage is likely to occur.

Summary of the Invention

[0005] The present disclosure provides a heart valve stent. The heart valve stent includes a support body and at least one protruding and extending branch structure connected to the support body. A flow passage through which blood flows is defined in the support body. The protruding and extending branch structure extends from the support body 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 self-valve leaflet of the heart is formed between the protruding and extending branch structure and the support body.

[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 respectively, and a second support structure connecting the two first support structures. A space that can be covered by the connection of a cover member is formed between the two first support structures and the second support structure.

[0007] The present disclosure further provides another type of heart valve stent. The heart valve stent is formed by braiding at least one elongated material into a specified shape. A flow passage through which blood flows is defined in the heart valve stent. At least one of the elongated materials protrudes and extends to the outside of the flow passage to form a protruding and extending portion capable of abutting against heart 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 respectively, and a second support structure connecting the two first support structures. A space that can be covered by the connection of a cover member is formed between the two first support structures and the second support structure.

[0009] Optionally, when the upstream direction and the downstream direction 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 each extend in the downstream direction from both ends of the second support structure, and the two first support structures merge and are connected.

[0011] Optionally, the two first support structures each extend in the downstream direction 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 and extending branch structure, and the protruding and extending branch structure is located between two adjacent support units in the circumferential direction of the support body.

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

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

[0015] Optionally, a connecting ring is formed at a 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 connection structure is provided at a position upstream of the connecting ring, and the connecting ring is formed as a closed ring by the first rivet connection structure.

[0018] Optionally, each of the support units and its adjacent support unit are connected by a rivet structure to form a second rivet connection structure. In the second rivet connection structure, the first support structure and the second support structure of two adjacent support units are parallel, and a gap for accommodating the self-valve cusp of the heart is formed between the protruding extension branch structure and the first support structure and the second support structure in the second rivet connection 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 continuous protruding extension segments and connection segments. The protruding extension segment bends and extends in a direction away from the flow passage. One end of the connection segment is connected to the protruding extension segment, and the other end is connected to the support body. The angle formed between the protruding extension segment and the axial direction of the flow passage is 1° to 150°.

[0021] Optionally, the horizontal distance a between the end of the connection segment connected 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 formed by braiding at least one elongated material.

[0023] Optionally, each of the support units further includes a third support structure, and a connection ring located downstream of the heart valve stent is formed by the third support structure.

[0024] Optionally, one end of the third support structure is connected to the first support structure, and the other end forms the protruding extension portion.

[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 segments form the protruding extensions. 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 includes a shape memory alloy wire.

[0033] Optionally, the second support structure is woven with a shape memory alloy wire having a diameter change, or A shape memory alloy tube is annularly installed on a part of the outer periphery of the second support structure.

[0034] The present disclosure further provides an implantable heart valve stent.

[0035] The implantable heart valve stent includes a plurality of support units, and a flow passage through which blood flows is defined and formed by the plurality of support units. At least one of the support units includes a protruding extended branch structure, and the protruding extended branch structure forms a protruding extension that can protrude and extend in a direction away from the flow passage and abut against heart tissue, and the protruding extended branch structure extends in the upstream direction of the flow passage to form a connection structure that can be connected to a cover member.

[0036] Optionally, each of the support units includes two first support structures for connecting to different valve tips, and a first space that can be covered by the connection of a cover member is formed between the two first support structures and the connection structure.

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

[0038] Optionally, the connection structure includes at least one sub-connection structure, and at least one of the sub-connection structures is installed overlapping or spaced apart from the connection structure.

[0039] Optionally, the two first support structures each extend in the downstream direction from both ends of the connection structure, and the two first support structures merge and are connected.

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

[0041] Optionally, each of the support units includes two of the protruding and extending branch structures, and the connection structures formed by the two protruding and extending branch structures are connected to each other.

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

[0043] Optionally, the protruding and extending branch structure and the first support structure are formed by braiding with a single braided wire.

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

[0045] Optionally, each of the support units and its adjacent support unit are connected by a rivet structure to form a first rivet joint structure. In the first rivet joint structure, the first support structures and the connection 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 joint structure.

[0047] Optionally, the protruding and extending branch structure includes a first connection segment, a contact segment, and a second connection segment that are sequentially connected. The first connection segment is connected to the first rivet joint structure. One end of the contact segment is connected to the first connection segment, and the second end protrudes and extends in a direction away from the flow passage. One end of the second connection segment is connected to the second end of the contact segment, and the other end is connected to the first support structure.

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

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

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

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

[0052] Optionally, the connection structure is formed by braiding with a shape memory alloy wire having a diameter change, or A shape memory alloy tube is annularly mounted on a part of the outer periphery of the connection structure.

[0053] The present disclosure further provides an artificial heart valve. The artificial heart valve includes a heart valve stent according to any one of the above or an implantable heart valve stent according to any one of the above, and A valve tip provided in the flow passage and connected to the first support structure of the heart valve stent or the implantable heart valve stent, A first sealing cover member installed and connected in a space formed between two first support structures and a second support structure of the heart valve stent or the implantable heart valve stent to cover the space.

[0054] Optionally, it further includes a second sealing cover member installed to surround the outer peripheral side of the heart valve stent or the implantable heart valve stent.

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

[0056] Optionally, the material of the valve tip is at least one of a polymer material, a biological tissue material, and a tissue engineering material.

[0057] Optionally, the connection method between the valve tip and the first support structure of the heart valve stent or the implantable heart valve stent is one of sewing with suture, adhesion, hot melt, and polymer adhesion.

[0058] The present disclosure provides another type of heart valve stent. The heart valve stent includes a support main body and at least one protruding and extending branch structure. The support main body includes a plurality of support units, and a passage through which blood flows 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 tips respectively. At least one of the support units includes a second support structure, and the second support structure is provided on the side of the first support structure close to its adjacent support unit. The protruding and extending branch structure is relatively fixed to two adjacent support units and extends from the support main body to the outside of the passage, and a gap for accommodating the self-valve tip of the heart is formed between the protruding and extending branch structure and the support main body.

[0059] Optionally, each of the support units includes two second support structures, and the two second support structures in each support unit are respectively provided on both sides of the two first support structures.

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

[0061] Optionally, each of the first support structures is fixed relative to one of the protruding and extending branch structures, and each of the protruding and extending branch structures is fixedly connected relative to two adjacent first support structures belonging to two adjacent support units respectively, and an intermediate portion of the protruding and extending branch structure forms a protruding and extending portion for abutting against the heart tissue.

[0062] Optionally, two adjacent second support structures belonging to two adjacent support units respectively are located between the protruding and extending branch structures connecting these two support units along the circumferential direction of the heart valve stent.

[0063] Optionally, two adjacent second support structures belonging to two adjacent support units respectively are located inside the protruding and extending branch structures connecting these two support units along the radial direction of the heart valve stent.

[0064] Optionally, a downstream portion of the two first support structures of the support unit and a downstream portion of the two protruding and extending branch structures are connected by a rivet structure to form a first rivet connection structure, and these two protruding and extending branch structures are two protruding and extending 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 and extending branch structures, and an intermediate portion of the protruding and extending branch structure forms a protruding and extending portion for abutting against the heart tissue.

[0066] Optionally, a part of two adjacent second support structures belonging to two adjacent support units respectively is located between the protruding and extending branch structures connecting these two support units along the circumferential direction of the heart valve stent.

[0067] Optionally, a part of two adjacent second support structures belonging to two adjacent support units respectively is located inside the protruding and extending branch structures connecting 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 joint structure, and the downstream portion of the protruding extended branch structure and the second support structure are connected by a rivet structure to form a second rivet joint structure.

[0069] Optionally, the upstream portions of two adjacent first support structures belonging to 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 joint structure.

[0070] Optionally, each support unit is formed by braiding with one braided wire, and each protruding extended branch structure is formed by another braided wire.

[0071] Optionally, the braided wire includes a diameter change portion, the diameter of the diameter change portion is larger than the diameter of other portions, and the diameter change portion is provided corresponding to the rivet structure.

[0072] Optionally, the braided wire is made of a shape memory alloy wire with a diameter change, thereby forming the diameter change portion, or A shape memory alloy tube is annularly mounted on the outer periphery of the braided wire, and the portion where the shape memory alloy tube is annularly mounted is the diameter change portion.

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

[0074] The present disclosure further provides a heart valve prosthesis. The heart valve prosthesis includes a heart valve stent according to any one of the above, a valve tip provided in the passage and connected to the first support structure of the heart valve stent, and a first cover member configured to cover the space formed between the two first support structures and the third support structure of the support unit of the heart valve stent by connection.

[0075] Optionally, the artificial heart valve further includes a second cover member, the second cover member is installed so as to surround the outer peripheral side of the heart valve stent, the upstream end of the second cover member is connected to the first cover member, and the second cover member has a gradually increasing and then gradually decreasing perimeter from the upstream end to the downstream end.

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

[0077] Optionally, a receiving notch is formed in the first flange and the second cover member, and the receiving notch is configured to receive the support body.

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

[0079] Optionally, the second flange is provided at the outer peripheral edge of the second cover member with the largest perimeter.

[0080] To more clearly explain the technical solutions of the embodiments of the present disclosure, the drawings used in the embodiments of the present disclosure will be briefly described below. The drawings to be described only show some embodiments of the present disclosure and do not limit the scope. Those skilled in the art can obtain other related drawings based on these drawings without using inventive capabilities. The directions of the arrows in FIGS. 1 and 6 indicate the direction of blood flow.

Brief Description of the Drawings

[0081]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

Figure 21

Figure 22

Figure 23

Figure 24

Figure 25

Figure 26

DETAILED DESCRIPTION OF THE INVENTION

[0082] Hereinafter, while referring to the drawings used in the embodiments of the present disclosure, the technical solutions in the embodiments of the present disclosure will be clearly and completely described. The described embodiments are only some embodiments of the present disclosure, not all embodiments. The components in the embodiments of the present disclosure shown in the drawings can be arranged and designed in various ways. For this reason, the following detailed description of the embodiments of the present disclosure shown in the drawings only shows the selected embodiments of the present disclosure and does not limit the scope of the present disclosure to be protected. Based on the embodiments of the present disclosure, those skilled in the art can also obtain all other embodiments without using inventive capabilities, which also belong to the protection scope of the present disclosure.

[0083] In the present disclosure, the directions or positional relationships represented by terms such as "upper", "lower", "left", "right", "front", "rear", "top", "bottom", "inner", "outer", "middle", "vertical", "horizontal", "lateral", and "longitudinal" are based on the drawings. These terms are merely for better explaining the present disclosure and its embodiments, and do not limit that the corresponding device, element, or component has a specific direction or is configured and operated in a specific direction.

[0084] And, in addition to being able to indicate a direction or positional relationship, some of the above terms may also be used to represent other meanings in some cases. For example, the term "upper" may, in some cases, be used to indicate a specific dependency or connection relationship. Those skilled in the art can understand the specific meanings of these terms in the present disclosure according to the specific situation.

[0085] Also, terms such as "mounting", "installing", "being provided", "connecting", and "coupling" should be understood in a broad sense. For example, it may be a fixed connection, a removable connection, or an integral connection. And it may be a mechanical connection or an electrical connection. Also, it may be a direct connection or an indirect connection via an intermediate, and the interiors of two devices, elements, or components may communicate with each other. Those skilled in the art can understand the specific meanings of the above terms in the present disclosure according to the specific situation.

[0086] Also, terms such as "first", "second", etc. are merely for mainly distinguishing different devices, elements, or components (the specific types or structures may be the same or different), and do not explicitly or implicitly indicate the relative importance or number of the corresponding devices, elements, or components. Unless otherwise specified, "a plurality" means "two or more".

[0087] In a first aspect, an embodiment of the present disclosure provides an (artificial) heart valve stent 10. The (artificial) heart valve stent 10 includes a support body 100 and at least one protruding and extending 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 and extending branch structure 200 extends from the support body 100 to the outside of the flow passage 120, and a protruding and extending portion 210 capable of abutting against heart tissue is formed on the protruding and extending branch structure 200. A gap 300 for accommodating the native valve leaflet 20 of the heart is formed between the protruding and extending branch structure 200 and the support body 100.

[0088] In the above embodiment, the (artificial) heart valve stent 10 includes a support body 100 and at least one protruding and extending branch structure 200 connected to the support body 100. The support body 100 is disposed at the position of the original aortic valve, and a flow passage 120 through which blood flows is defined in the middle portion of the support body 100. The protruding and extending branch structure 200 extends from the support body 100 to the outside spaced apart from the flow passage 120, and a protruding and extending portion 210 capable of abutting against heart tissue (such as the sinus of Valsalva) is formed on the protruding and extending branch structure 200. Thus, when the (artificial) heart valve stent 10 is disposed at the position of the original aortic valve, the protruding and extending portion 210 abuts against the heart tissue to play a role in fixing the (artificial) heart valve stent 10, and it is possible to prevent the (artificial) heart valve stent 10 from being displaced under the action of the pressure of the blood on the valve leaflet 20 when the valve leaflet 20 closes. Thereby, the stability and reliability of the placement of the heart valve stent at the position of the original aortic valve can be improved, and the service life of the (artificial) heart valve stent 10 can be extended. And there is a gap between the protruding and extending branch structure 200 and the support body 100. Thus, when the (artificial) heart valve stent 10 is attached to the position of the original aortic valve, the native valve leaflet 20 of the heart can be accommodated in the gap, preventing blockage of the coronary artery caused by mutual interference between the native valve leaflet 20 of the heart and the (artificial) heart valve stent 10, and contributing to the improvement of the safety during the attachment of the (artificial) heart valve stent 10.

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

[0090] In the above embodiment, the (artificial) heart valve stent 10 includes a plurality of support units 110, and the plurality of support units 110 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 respectively connected to one ends of the two first support structures 111. A space that can be covered by the connection of a cover member is formed between the second support structure 112 and the two first support structures 111. When the space is covered by the connection of the cover member, blood can only flow through the flow passage 120, thereby preventing blood from flowing on the outer peripheral side of the (artificial) heart valve stent 10.

[0091] Exemplarily, the number of support units 110 is three, and the three support units 110 form the support body 100.

[0092] In some embodiments, when the upstream direction and the downstream direction are defined along the direction in which blood flows through the flow passage 120, 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 inlet end is formed in the direction where the second support structure 112 is located, and a blood outlet end is formed in the direction where the two first support structures 111 are located. Blood flows in from the direction where the second support structure 112 is located and flows out from the direction where the first support structure 111 is located.

[0094] In some embodiments, the two first support structures 111 each extend from both ends of the second support structure 112 in the downstream direction, and the two first support structures 111 merge and are connected.

[0095] In the above embodiment, the two first support structures 111 have their first ends respectively connected to both ends of the second support structure 112, and their second ends extend in the downstream direction of the flow passage 120 and merge and are connected, so that a closed space that can be covered by the connection of the cover member is formed between the two first support structures 111 and the second support structure 112. The second ends of the two first support structures 111 can be connected by rivet tube connection or welding.

[0096] In some embodiments, each of the support units 110 is connected to the protruding and extending branch structure 200, and the protruding and extending 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 a plurality of protruding and extending branch structures 200, and each support unit 110 is connected to the protruding and extending branch structure 200. Specifically, the plurality of protruding and extending branch structures 200 are installed at intervals and are located between two adjacent support units 110 in the circumferential direction of the support body 100. In this way, when the protruding and extending portions 210 of the plurality of protruding and extending branch structures 200 abut against the heart tissue (for example, the sinus of Valsalva), the reliability and stability of the (artificial) heart valve stent 10 after being attached can be effectively improved.

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

[0099] In the above embodiment, ends of each 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 improving the certainty and stability when the protruding extension portion 210 abuts against the heart 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, and no further connection by means such as welding or riveting is required, which can contribute to improving the production efficiency of the product.

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

[0103] In the above embodiment, a connection ring 400 is formed on the first support structure 111. The connection ring 400 is located downstream of the flow passage 120 and is connected to the delivery system of the (artificial) heart valve stent 10 to realize the delivery and retrieval of the (artificial) heart valve stent 10 by the delivery system.

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

[0105] In the above embodiment, there are a plurality of connection rings 400, and all of the plurality of connection rings 400 are located downstream of the flow passage 120. If all of the plurality of connection rings 400 are connected to the delivery system of 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 connection structure 114 is provided at a position upstream of the connection ring 400, and the connection ring 400 is formed as a closed ring by the first rivet connection structure 114.

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

[0108] In some embodiments, each of the support units 110 and the adjacent support unit 110 are connected by a rivet structure to form a second rivet connection structure 115. In the second rivet connection structure 115, 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 self-valve tip 20 of the heart 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 connection 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 of the two first support structures 111 and the second support structures 112 of each support unit 110 and the connection points of the two first support structures 111 and the second support structures 112 of the adjacent support unit 110 are connected by a rivet structure to form a second rivet connection structure 115. In the first rivet connection structure 114, the first support structure 111 and the second support structure 112 of two adjacent support units 110 are arranged in parallel, thereby contributing to improving the certainty of the connection of each support unit 110, improving the aesthetics of the product, and the protruding extension branch structure 200 and the first support structure 111 and the second support structure 112 in the second rivet connection structure 115 are installed at intervals to define a gap for accommodating the self-valve tip 20 of the heart.

[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 of the two first support structures 111 of each support unit 110, which are located downstream of the flow passage 120, are connected by a rivet structure such as a rivet tube to form a third rivet connection structure 116. Thereby, a reliable connection of the ends of the two first support structures 111 of each support unit 110, which are located downstream of the flow passage 120, can be effectively ensured.

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

[0113] In the above embodiment, the protruding and extending segment 220 is located downstream of the flow passage 120. One end of the connecting segment 230 is connected to the protruding and extending 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 main body 100. By setting the angle formed between the protruding and extending segment 220 and the axial direction of the flow passage 120 to be 1° to 150°, it contributes to the protruding and extending 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 the improvement of the stability when the protruding and extending segment 220 abuts against the heart tissue.

[0114] Specifically, a mounting space for passing a medical device such as a coronary stent is defined between the connecting segment 230 and the first support structure 111.

[0115] In some embodiments, the horizontal distance a between the end of the connection 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 embodiments, by setting the distance a between the end of the connection segment 230 that connects 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 can be ensured that the protruding extension segment 220 can abut against the heart tissue, and it can be prevented that the protruding extension segment 220 protrudes and extends excessively to damage other tissues of the heart. On the other hand, after the natural valve leaflet 20 of the heart abuts against the side close to the support body 100 of the protruding extension segment 220, it can be accommodated in the gap between the protruding extension branch structure 200 and the support body 100, and the natural valve leaflet 20 of the heart can be easily accommodated in the gap.

[0117] In some embodiments, the heart valve stent 10 is formed by braiding with at least one elongated material.

[0118] In the above embodiments, exemplarily, the elongated material is a shape memory alloy wire or a nickel-titanium alloy wire, etc. When the (artificial) heart valve stent 10 is formed by braiding with one elongated material, its integrity is relatively high and it can contribute to processing and forming. When the (artificial) heart valve stent 10 is formed by braiding with a plurality of elongated materials, the two connected elongated materials can be fixedly connected by connection with a rivet tube or welding. Also, the connection points of the two connected elongated materials can be fixedly connected by welding or screw connection.

[0119] In a second aspect, one embodiment of the present disclosure further provides another heart valve stent 10. The heart valve stent 10 is formed by braiding at least one elongated material into a defined shape, and a flow passage 120 through which blood flows is defined in the heart valve stent 10. At least one elongated material protrudes and extends outwardly beyond the flow passage 120 to form a protruding extension portion 210 capable of abutting against heart tissue.

[0120] The heart valve stent 10 according to an embodiment of the present disclosure is disposed at the position of the original aortic valve. The heart valve stent 10 is formed by braiding at least one elongated material into a defined shape, and a flow passage 120 through which blood flows is defined in an intermediate portion of the heart valve stent 10. Exemplarily, the elongated material is a shape memory alloy wire or a nickel-titanium alloy wire, etc. A part of at least one elongated material protrudes and extends outwardly away from the flow passage 120 to form a protruding extension portion 210 capable of abutting against heart tissue (such as the sinus of Valsalva). Thereby, when the heart valve stent 10 is disposed at the position of the original aortic valve, the protruding extension portion 210 abuts against the heart tissue, which serves to fix the heart valve stent 10, and it is possible to prevent the heart valve stent 10 from being displaced under the action of the pressure of blood at the valve tip 20 when the valve tip 20 closes. Thereby, the stability and reliability of the placement of the heart valve stent 10 at the position of the original aortic valve can be improved, the service life of the heart valve stent 10 can be extended, and it can contribute to the improvement of the stability of the heart valve stent 10 used in patients without calcification.

[0121] In some embodiments, the heart valve stent 10 includes a plurality of support units 110, and the flow passage 120 is defined and formed by the plurality of support units 110. Each support unit 110 includes two first support structures 111 for connecting to different valve tips 20 respectively, and a second support structure 112 connecting the two first support structures 111. A space capable of being covered by the connection of a cover member is formed between the two first support structures 111 and the second support structure 112.

[0122] In some embodiments, the heart valve stent 10 includes a plurality of support units 110, and the plurality of support units 110 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 respectively connected to one ends of the two first support structures 111. A space that can be covered by connection of a cover member is formed between the second support structure 112 and the two first support structures 111. When the space is covered by connection of the cover member, blood can only flow through the flow passage 120, thereby preventing blood from flowing on the outer peripheral side of the heart valve stent 10.

[0123] Exemplarily, the number of support units 110 is three.

[0124] In some embodiments, when an upstream direction and a downstream direction are defined along the direction in which blood flows through the flow passage 120, 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 where the second support structure 112 is located, and blood outflow ends are formed in the two first support structures 111. Blood flows in from the direction where the second support structure 112 is located and flows out from the direction where the first support structure 111 is located.

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

[0127] In the above-described embodiment, the two first support structures 111 have their first ends respectively connected to both ends of the second support structure 112, extend in the downstream direction of the flow passage 120, and the second ends of the two first support structures 111 are connected to each other, thereby forming a closed space between the second support structure 112 that can be covered by the connection of the cover member. The second ends of the two first support structures 111 can be connected by rivet tube connection or welding.

[0128] In some embodiments, each of the support units 110 further includes a third support structure 113, and a connection ring 400 located downstream of the heart valve stent 10 is formed by the third support structure 113.

[0129] In the above-described embodiment, the support unit 110 further includes a third support structure 113, and a connection ring 400 located downstream of the heart valve stent 10 is formed by the third support structure 113. The connection ring 400 is connected to the delivery system of the heart valve stent 10 to realize the delivery and retrieval of the heart valve stent 10 by the delivery system.

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

[0131] In some embodiments, after the end of the third support structure 113 located downstream of the heart valve stent 10 forms the connection ring 400, it is 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 rivet connection or welding.

[0132] In some embodiments, each of the support units 110 has two of the 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 ends of the two third support structures 113 respectively form the protruding extension portions 210.

[0133] 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 that are located downstream of the flow passage 120, and the other ends respectively form protruding extension portions 210 that can abut against the heart tissue.

[0134] In some embodiments, one connection ring 400 is respectively formed at the most downstream position of each of the third support structures 113.

[0135] In the above embodiments, one connection ring 400 is respectively formed at the most downstream position of each of the third support structures 113. The connection ring 400 is connected to the connection structure of the conveying system, and the heart valve stent 10 can be fed into the heart tissue by the feeding mechanism, so that the feeding stability and reliability can be improved.

[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 the two adjacent protruding extension portions 210 are continuously formed.

[0137] In the above embodiments, the two adjacent protruding extension portions 210 in the two adjacent support units 110 are formed by bending the same elongated material and are continuously formed, which can prevent the heart tissue from being damaged by the protruding extension portion 210 due to stress concentration. Furthermore, the support strength of the protruding extension portion 210 can be improved, and the mounting reliability of the heart valve stent 10 can be improved.

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

[0139] In the above embodiment, each support unit 110 and its 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 its adjacent support unit 110 are connected by a rivet structure to form two first rivet joint structures 114, and the third support structure 113 is also connected to the first rivet joint structure 114. In the first rivet joint structure 114, each elongated material is arranged in parallel, thereby contributing to improving the connection reliability of each support unit 110, improving the aesthetics of the product, and contributing to the protruding extension part 210 of each support unit 110 being located in the middle of the support unit 110 and contacting the heart 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 joint structure 115, and the third support structure 113 is also connected to the second rivet joint structure 115.

[0141] In the above embodiment, the connection points located downstream of the flow passage 120 between the two first support structures 111 of each support unit 110 are connected by a rivet structure such as a rivet tube to form a second rivet joint structure 115, and the two third support structures 113 of each support unit 110 are also connected to the second rivet joint structure 115, effectively ensuring the 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 and extending direction of the protruding and extending 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 formed between the plane where the protruding and extending portion 210 is located and the direction perpendicular to the axial direction of the flow passage 120 to 15° to 90°, when the heart valve stent 10 is disposed at the position of the original aortic valve, the protruding and extending portion 210 can contribute to contacting the heart tissue corresponding to the position of the heart tissue, and can contribute to improving the stability of the contact between the protruding and extending portion 210 and the heart 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 and extending segment 220, a transition segment 240, and a connection segment 230. The protruding and extending segment 220 forms the protruding and extending portion 210. One end of the transition segment 240 is connected to the protruding and extending segment 220, and the other end is bent and extended in a direction away from the flow passage 120. The angle formed between the transition segment 240 and the direction perpendicular to the axial direction of the flow passage 120 is 60° to 150°. One end of the connection segment 230 is connected to the transition segment 240, and the other end is connected to the first support structure 111.

[0145] In the above-described embodiment, the third support structure 113 includes a protruding extension segment 220, a transition segment 240, and a connection segment 230 that are sequentially connected along the flow direction of the flow passage 120. The protruding extension segment 220 protrudes and extends outward from the flow passage 120 to form a protruding extension portion 210 that can abut against the heart tissue. One end of the transition segment 240 is connected to the protruding extension segment 220, and the other end is bent and extended in a direction away from the flow passage 120. The angle formed between the transition segment 240 and the direction perpendicular to the axial direction of the flow passage 120 is 60° to 150°. Thereby, the original aortic valve location can be expanded by the heart valve stent 10 to ensure normal blood flow. One end of the connection segment 230 is connected to the transition segment 240, and the other end is bent and extended in a direction close to the first support structure 111. After forming the connection ring 400 at the most downstream portion of the flow passage 120, it is connected to the first support structure 111. Thereby, a relatively large space is defined between the third support structure 113 and the valve tip 20, and when a coronary artery stent implantation operation is performed on a patient, the coronary artery stent can be attached using this space.

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

[0147] In the above-described embodiment, the heart valve stent 10 includes a plurality of support units 110, and the plurality of support units 110 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 and extending branch structure 200, and the protruding and extending branch structure 200 forms a protruding and extending portion 210 that protrudes and extends in a direction away from the flow passage 120 and can abut against heart tissue. Thus, when the heart valve stent 10 is disposed at the position of the original aortic valve, the protruding and extending portion 210 abuts against the heart tissue, thereby playing a role in fixing the heart valve stent 10, and preventing the heart valve stent 10 from being displaced under the action of the pressure of the blood at the valve tip 20 when the valve tip 20 closes. The stability and reliability of the placement of the heart valve stent at the position of the original aortic valve can be improved, and the service life of the heart valve stent 10 can be extended. And the protruding and extending portion 210 extends upstream of the flow passage 120 to form a connection structure 250 that can be connected to a sealing cover member. After the sealing cover member and the connection structure 250 are connected, it is possible to prevent blood from flowing on the outer peripheral side of the flow passage 120, and improve the smoothness when blood flows along the axial direction of the flow passage 120.

[0148] Optionally, in the case of a patient with relatively severe calcification of the valve tip 20, the protruding and extending portion 210 directly abuts against the calcified valve tip 20 of the patient. Since the hardness of the calcified valve tip 20 is relatively large, when the protruding and extending portion 210 abuts against the calcified valve tip 20, it can play a good supporting role, and the reliability and stability when the heart valve is disposed at the location of the original heart valve can be guaranteed.

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

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

[0151] In some embodiments, when the upstream direction and the downstream direction are defined along the direction in which blood flows through the flow passage 120, the connection structure 250 is located upstream of the two first support structures 111 and is continuously formed with the end of the protruding and extending branch structure 200 that is located upstream of the flow passage 120 to form the connection structure 250.

[0152] In the above-described embodiment, the connection structure 250 is located upstream of the two first support structures 111. That is, a blood inflow end is formed in the direction where the connection structure 250 is located, and a blood outflow end is formed in the direction where the two first support structures 111 are located. Blood flows in from the direction where the connection structure 250 is located and flows out from the direction where the first support structure 111 is located. The connection structure 250 is continuously formed with the end of the protruding and extending branch structure 200 that is located upstream of the flow passage 120 and is formed as a connection structure 250 that can be covered by connecting cover members.

[0153] In some embodiments, the connection structure 250 includes at least one sub-connection structure 251, and at least one of the sub-connection structures 251 is installed overlapping or spaced apart from the connection structure 250.

[0154] In the above-described 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, increasing the support strength when the connection structure 250 is supported at the location of the original heart valve and improving the stability when the heart valve stent 10 is installed.

[0155] In some embodiments, the two first support structures 111 each extend from both ends of the connection structure 250 in the downstream direction, and the two first support structures 111 merge and are connected.

[0156] In the above embodiment, the two first support structures 111 are each connected to both ends of the connection structure 250 at the first end, and the second ends extend in the downstream direction of the flow passage 120 and merge and are connected, so that a closed space that can be covered by the connection of the cover member is formed between the connection structure 250.

[0157] Exemplarily, as the connection method of the second ends of the two first support structures 111 and the connection method between the two first support structures 111 and the connection structure 250, connection by a rivet tube or welding can be used.

[0158] In some embodiments, each of the support units 110 includes the protruding and extending branch structure 200, and the protruding and extending 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 a plurality of protruding and extending branch structures 200, and each support unit 110 includes the protruding and extending branch structure 200. Specifically, the plurality of protruding and extending branch structures 200 are installed at intervals and are located between two adjacent support units 110 in the circumferential direction of the support main body 100. In this way, by the protruding and extending portions 210 of the plurality of protruding and extending branch structures 200 abutting against the heart tissue (for example, the calcified valve leaflet 20), the reliability and stability of the heart valve stent 10 after installation can be effectively improved.

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

[0161] In the above-described embodiment, when the connection structures 250 formed by the two protruding and extending branch structures 200 of each support unit 110 are connected to each other (for example, integral connection, welding, or rivet connection, etc.), it can contribute to improving the stability when covering the space formed between the connection structure 250 and the first support structure 111 by the connection of the sealing cover member, can contribute to improving the integrity of the product, and can improve the reliability and stability when the heart valve stent 10 is placed at the location of the original heart valve.

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

[0163] In the above-described embodiment, a second space 600-B for passing a medical device such as a coronary artery stent is formed between each protruding and extending branch structure 200 and the first support structure 111 connected thereto. Thereby, after the heart valve stent 10 is attached, a medical device such as a coronary artery stent can be easily attached.

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

[0165] In the above-described embodiment, the protruding and extending branch structure 200 and the first support structure 111 are formed by braiding with a single braided wire 131. Since these two structures are continuously formed, further connection by means such as welding or rivet connection is unnecessary, which can contribute to improving the production efficiency of the product and can contribute to improving the integrity of the product.

[0166] In some embodiments, a connection ring 400 is formed at the end of the protruding and extending branch structure 200 located downstream of the flow passage 120.

[0167] In the above-described embodiment, a connection ring 400 is provided on the protruding extension branch structure 200. The connection ring 400 is located downstream of the flow passage 120 and is connected to the delivery system of the (artificial) heart valve stent 10, so as to realize the delivery and retrieval of the heart valve stent 10 by the delivery system.

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

[0169] In the above-described embodiment, each support unit 110 and its two adjacent support units 110 are connected by a rivet structure, that is, the connection points of the two first support structures 111 and the connection structure 250 of each support unit 110, and the connection points of the two first support structures 111 and the connection structure 250 of its adjacent support unit 110 are connected by a rivet structure to form a first rivet connection structure 114. In the first rivet connection structure 114, the first support structure 111 and the connection structure 250 of two adjacent support units 110 are arranged in parallel. Thereby, it can contribute to improving the certainty of connection of each support unit 110, improving the aesthetics 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 connection structure 115 and is continuously formed with the connection 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 connection structure 115.

[0171] In the above embodiment, the connection points of the two first support structures 111 of each support unit 110, which are located downstream of the flow passage 120, are connected by a rivet structure such as a rivet tube to form a second rivet joint structure 115, thereby effectively ensuring the reliable connection of the ends of the two first support structures 111 of each support unit 110, which are located downstream of the flow passage 120.

[0172] In some embodiments, the protruding and extending branch structure 200 includes a first connection segment 230, an abutting segment, and a second connection segment 230 that are connected in sequence. The first connection segment 230 is connected to the first rivet joint structure 114. One end of the abutting segment is connected to the first connection segment 230, and the other end protrudes and extends in a direction away from the flow passage 120. One end of the second connection segment 230 is connected to the other end of the abutting segment, and the other end is connected to the first support structure 111.

[0173] In the above embodiment, the protruding and extending branch structure 200 includes a first connection segment 230, an abutting segment, and a second connection segment 230 that are connected in sequence. At least a part of the first connection segment 230 is located in the first rivet joint structure 114 and is continuously formed with the connection structure 250. One end of the abutting segment is connected to the first connection segment 230, and the other end protrudes and extends outside the flow passage 120 to form a protruding and extending portion 210 that can abut against the heart tissue. One end of the second connection segment 230 is connected to the abutting segment, and the other end extends in a direction close to the flow passage 120 and is connected to the first support structure 111.

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

[0175] In the above embodiment, by setting the angle α formed between the abutting segment and the axial direction of the flow passage 120 to be 10° to 150°, it contributes to the abutting segment abutting on the position of the heart tissue (for example, the calcified valve cusp 20), and can contribute to the improvement of the stability when the abutting segment abuts on the heart tissue.

[0176] In some embodiments, the distance b between the second end of the abutting 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 rivet connection structure 114 along the axial direction of the flow passage 120. By setting the distance b between the second end of the abutting segment and the first connecting segment 230 to be 1 mm to 20 mm, on the one hand, it can ensure that the abutting segment abuts on the heart tissue, and on the other hand, it can prevent the abutting segment from protruding and extending excessively outside the flow passage 120 and damaging the heart tissue.

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

[0179] In the above embodiment, illustratively, the braided wire 131 is a shape memory alloy wire or a nickel-titanium alloy wire, etc. When the heart valve stent 10 is formed by braiding with one braided wire 131, its integrity is relatively high and it can contribute to processing and forming. When the heart valve stent 10 is formed by braiding with a plurality of elongated materials, the two connected elongated materials can be fixedly connected by rivet tube connection or welding. Also, the connection points of the two connected elongated materials can be fixedly connected by welding or screw connection.

[0180] In some embodiments, the connection structure 250 is formed by braiding with a shape memory alloy wire with a diameter change, or a shape memory alloy tube 500 is annularly installed on a part of the outer periphery of the connection structure 250.

[0181] In the above embodiment, the connection structure 250 is formed by braiding with a shape memory alloy wire having a diameter change, or a shape memory alloy tube 500 is mounted around a part of the outer periphery of the connection structure 250, so that the diameter of a part of the connection structure 250 is increased, the supporting force of the support by the heart valve stent 10 can be increased, and the stability of the support can be improved.

[0182] In some embodiments, the heart valve stent 10 according to the above first aspect and / or second aspect and / or third aspect includes an elongated material or braided wire 131 including a shape memory alloy wire.

[0183] In the heart valve stent 10 according to the above first aspect and / or second aspect, in the above embodiment, the (artificial) heart valve stent 10 is formed by braiding with at least one shape memory alloy wire. The shape memory alloy wire can be deformed when receiving 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 10 is arranged and attached at the location of the aortic valve. When the heart valve stent 10 is formed by braiding with a plurality of shape memory alloy wires, the two connected shape memory alloy wires can be fixedly connected by connection with a rivet tube or welding. Further, the heart valve stent 10 can be fixedly connected by welding or screw connection.

[0184] In some embodiments, the heart valve stent 10 according to the above first aspect and / or second aspect is formed by braiding the second support structure 112 with at least one shape memory alloy wire having a diameter change, or a shape memory alloy tube 500 is mounted around a part of the outer periphery of the second support structure 112.

[0185] In the above-described first aspect and / or second aspect, for the heart valve stent 10, in the above embodiment, the second support structure 112 is formed by braiding with a shape memory alloy wire with a diameter change, or a shape memory alloy tube 500 is looped around a part of the outer periphery of the second support structure 112, so that the diameter of a part of the second support structure 112 can be increased, 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, an embodiment of the present disclosure further provides another artificial heart valve 1. The other artificial heart valve 1 includes the (artificial) heart valve stent 10 of the heart valve stent 10 according to the first aspect or the second aspect, or the implantable heart valve stent 10 according to the third aspect, a valve tip 20 provided in the flow passage 120 and connected to the first support structure 111 of the (artificial) heart valve stent 10, and 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 so as to surround the outer peripheral side of the (artificial) heart valve stent 10. In some embodiments, the second sealing cover member 40 is installed so as to surround the outer peripheral side of the first sealing cover member 30 and is hermetically connected to the first sealing cover member 30.

[0187] In the above embodiment, the valve tip 20 is located within the flow passage 120 and is connected to the first support structure 111 of the heart valve stent 10. The opening and closing of the valve tip 20 can control the blood flow. For example, when the heart contracts, the valve tip 20 opens to send the blood in the heart to the whole body through the aorta. And when the heart relaxes, the valve tip 20 closes in a timely manner to prevent the blood in the aorta from returning to the ventricle. The first sealing cover member 30 is respectively installed in the space formed between the two first support structures 111 and the second support structures 112 of each support unit 110 of the heart valve stent 10. Thereby, it can prevent the blood from flowing on the outer peripheral side of the heart valve stent 10 and ensure that the blood flows in from the blood inflow end and flows out from the blood outflow end. The second sealing cover member 40 is installed so as to surround the outer peripheral side of the (artificial) heart valve stent 10 and is configured to prevent the backflow of blood and prevent the perivalvular backflow.

[0188] In some embodiments, the second sealing cover member 40 has a disc shape, 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 has a disc shape. Thereby, when the heart valve stent 10 is arranged at the position of the original aortic valve, 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 is bent downstream of the heart valve stent 10 to form a protruding edge. In this way, when the valve tip 20 closes, the blood can only flow upward from the valve tip 20 to the second sealing cover member 40, flow above the second sealing cover member 40, effectively prevent the backflow of blood, and prevent the perivalvular backflow.

[0190] In some embodiments, the material of the valve tip 20 is one of a polymer material, a biological tissue material, and a tissue engineering material.

[0191] In the above embodiment, illustratively, the material of the valve tip 20 is a material such as bovine pericardium, porcine pericardium, bovine / porcine heart valve.

[0192] In some embodiments, the connection method between the valve tip 20 and the first support structure 111 of the (artificial) heart valve stent 10 is one of adhesion, hot melt, and polymer adhesion.

[0193] In the above embodiment, the valve tip 20 is fixedly connected to the first support structure 111 of the (artificial) heart valve stent 10 by one of the methods of adhesion, hot melt, and polymer adhesion, so as to avoid damage and detachment of the valve tip 20 caused by stress concentration, and contribute to the improvement of the service life of the product.

[0194] In a fifth aspect, an embodiment of the present disclosure further provides another heart valve stent 10. This heart valve stent 10 includes a support main body 100 and at least one protruding and extending branch structure 200. The support main body 100 includes a plurality of support units 110, and a passage 120 through which blood flows is defined and formed by the plurality of support units 110. Each of the support units 110 includes two first support structures 111 for connecting to different valve tips 20 respectively. At least one of the support units 110 includes a second support structure 112, and the second support structure 112 is provided on the side of the first support structure 111 close to its adjacent support unit 110. The protruding and extending branch structure 200 is relatively fixed to two adjacent support units 110 and extends outward from the support main body 100 to the outside of the passage 120, and a gap 300 for accommodating the natural valve tip 20 of the heart is formed between the protruding and extending branch structure 200 and the support main body 100.

[0195] The present disclosure forms the support main body 100 by installing the first support structure 111 and the second support structure 112, so that the structure of the support main body 100 becomes stronger, the passage 120 is not easily deformed, and by installing the protruding and extending branch structure 200 that contacts the heart tissue, the heart valve stent 10 is not easily dislodged and becomes stronger after being implanted in the heart, the service life of the heart valve stent 10 can be extended, and the risk of re-replacing the valve of the patient can be reduced.

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

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

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

[0199] In the above realization 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, and blood backflow can be prevented.

[0200] In some embodiments, each of the first support structures 111 is relatively fixed to one of the protruding and extending branch structures 200, and each of the protruding and extending branch structures 200 is relatively fixedly connected to two adjacent first support structures 111 belonging to two adjacent support units 110 respectively, and an intermediate portion of the protruding and extending branch structure 200 forms a protruding and extending portion 210 for abutting against heart tissue.

[0201] In the above realization process, by connecting each protruding and extending branch structure 200 to two adjacent first support structures 111, the overall structure of the heart valve stent 10 can be made more stable, and by forming the protruding and extending portion 210 by the intermediate portion of the protruding and extending branch structure 200, abutment with heart tissue can be realized, and the heart valve stent 10 can be more stably arranged at a predetermined position of the heart.

[0202] In some embodiments, two adjacent second support structures 112 belonging to each of two adjacent support units 110 are located between two support units 110 and a protruding extended branch structure 200 connecting therewith along the circumferential direction of the heart valve stent 10.

[0203] In the above realization process, since two adjacent second support structures 112 belonging to each of two adjacent support units 110 are located between two support units 110 and a protruding extended branch structure 200 connecting therewith along the circumferential direction of the heart valve stent 10, the second support structure 112 can better play a supporting role and strengthen the structure of the heart valve stent 10.

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

[0205] In the above realization process, since two adjacent second support structures 112 belonging to each of two adjacent support units 110 are located inside the protruding extended branch structure 200 connecting the two support units 110 along the radial direction of the heart valve stent 10, the second support structure 112 can better play a supporting role and strengthen the structure of the heart valve stent 10. Moreover, since a gap 300 for accommodating the native leaflet 20 of the heart is formed between the protruding extended branch structure 200 and the support body 100, the protruding extended branch structure 200 contributes to abutting against the heart tissue, and the heart valve stent 10 can be more stably arranged at a predetermined position of the heart.

[0206] In some embodiments, a downstream portion of the two first support structures 111 of the support unit 110 and a downstream portion of the two protruding extended branch structures 200 are connected by a rivet structure to form a first rivet joint structure 114, and the two protruding extended branch structures 200 are two protruding extended branch structures 200 that are relatively fixed to the two first support structures 111.

[0207] In the above realization process, by connecting the first support structure 111 and the protruding and extending branching structure 200 through a rivet structure, the structures of the first support structure 111 and the protruding and extending branching structure 200 are not easily deformed and become stronger, and the overall structure of the heart valve stent 10 becomes stronger.

[0208] In some embodiments, each of the second support structures 112 is relatively fixed to one of the protruding and extending branching structures 200, and an intermediate portion of the protruding and extending branching structure 200 forms a protruding and extending portion 210 for abutting against heart tissue.

[0209] In the above realization process, by connecting each protruding and extending branching structure 200 to one second support structure 112 respectively, the overall structure of the heart valve stent 10 can be made more stable, and by forming the protruding and extending portion 210 with the intermediate portion of the protruding and extending branching structure 200, abutting against the heart tissue can be realized, and the heart valve stent 10 can be arranged more stably at a predetermined position of the heart.

[0210] In some embodiments, a part of two adjacent second support structures 112 belonging to two adjacent support units 110 respectively is located between the protruding and extending branching structures 200 connecting these two support units 110 along the circumferential direction of the heart valve stent 10.

[0211] In the above realization process, by a part of two adjacent second support structures 112 belonging to two adjacent support units 110 respectively being located between the protruding and extending branching structures 200 connecting these two support units 110 along the circumferential direction of the heart valve stent 10, the second support structure 112 can play a better supporting role, and the structure of the heart valve stent 10 can be made stronger.

[0212] In some embodiments, a part of two adjacent second support structures 112 belonging to two adjacent support units 110 is located inside the protruding and extending branch structure 200 connecting the two support units 110 along the radial direction of the heart valve stent 10.

[0213] In the above realization process, a part of two adjacent second support structures 112 belonging to two adjacent support units 110 is located inside the protruding and extending branch structure 200 connecting the two support units 110 along the radial direction of the heart valve stent 10. As a result, the second support structure 112 can better play a supporting role and strengthen the structure of the heart valve stent 10. Since a gap 300 for accommodating the self-valve tip 20 of the heart is formed between the protruding and extending branch structure 200 and the support main body 100, the protruding and extending branch structure 200 contributes to contacting the heart tissue, and the heart valve stent 10 can be more stably arranged at a predetermined position of 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 connection structure 114, and the downstream portion of the protruding and extending branch structure 200 and the second support structure 112 are connected by a rivet structure to form a second rivet connection structure 115.

[0215] In the above realization process, by connecting the two first support structures 111 of the support unit 110 and connecting the protruding and extending branch structure 200 and the second support structure 112 by a rivet structure, the structures of the first support structure 111, the protruding and extending branch structure 200, and the second support structure 112 are less likely to be deformed and become stronger, and the overall structure of the heart valve stent 10 becomes stronger.

[0216] In some embodiments, the upstream portions of two adjacent first support structures 111 belonging to 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 connection structure 116.

[0217] In the above realization 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 are less likely to be deformed and become stronger, and the overall structure of the heart valve stent 10 becomes stronger.

[0218] In some embodiments, each of the support units 110 is formed by braiding with a single braided wire 131, and each protruding and extending branch structure 200 is formed by another single braided wire 131.

[0219] In the above realization process, by braiding with a single braided wire 131 to form one support unit 110, it can contribute to the production of the support unit 110, no other connection structure is required, and the structure of the support unit 110 can be made simpler and stronger. By forming the protruding and extending branch structure 200 with another single braided wire 131, it contributes to forming a gap 300 for accommodating the self-valve tip 20 of the heart between the protruding and extending branch structure 200 and the support main body 100, so that the protruding and extending branch structure 200 can contact the heart tissue.

[0220] In some embodiments, the braided wire 131 includes a diameter-changing portion 134, the diameter of the diameter-changing portion 134 is larger than the diameters of other portions, and the diameter-changing portion 134 is provided corresponding to the rivet structure.

[0221] In the above realization process, by providing the diameter-changing portion 134 of the braided wire 131 corresponding to the rivet structure, it can contribute to the rivet connection of the braided wire 131, and it is less likely to occur that the braided wire 131 slides within the rivet connection structure or slips out of the rivet connection structure, and the rivet connection is stronger.

[0222] In some embodiments, the braided wire 131 is made of a shape memory alloy wire with a diameter change, thereby forming the diameter change portion 134, or a shape memory alloy tube 500 is annularly mounted on the outer periphery of the braided wire 131, and the portion where the shape memory alloy tube 500 is annularly mounted is the diameter change portion 134.

[0223] In the above realization process, by forming the diameter change portion 134 with a shape memory alloy wire with a diameter change as the braided wire 131, the mounting process of the rivet structure can be simplified, and by annularly mounting the shape memory alloy tube 500 on the outer periphery of the braided wire 131 to form the diameter change portion 134, the braiding production process of 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 of the support units 110.

[0225] In the above realization process, since the connecting ring 400 is formed downstream of the support unit 110, the support unit 110 can be formed by braiding with a single braided wire 131, and the structure of the support unit 110 becomes stronger.

[0226] In a sixth aspect, an embodiment of the present disclosure further provides another artificial heart valve 1. The other artificial heart valve 1 includes the above heart valve stent 10, a valve tip 20 provided in the passage 120 and connected to the first support structure 111 of the heart valve stent 10, and a first cover member 50 configured to cover 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 by connection.

[0227] In the above realization process, by installing the first support structure 111 and the second support structure 112 to form the support main body 100, the structure of the support main body 100 becomes stronger, the passage 120 is less likely to deform, and by installing the protruding extended branch structure 200 that abuts against the heart tissue, after the heart valve stent 10 is implanted in the heart, it is difficult to come off and becomes stronger, the service life of the heart valve stent 10 can be extended, and the risk of re-replacing the patient's valve can be reduced. By installing the valve tip 20 and the first cover member 50, blood flows from the upstream to the downstream of the support main body 100, and no backflow occurs.

[0228] In some embodiments, the artificial heart valve 1 further includes a second cover member 60, the second cover member 60 is installed to surround the outer peripheral side of the heart valve stent 10, the upstream end of the second cover member 60 is connected to the first cover member 50, and the second cover member 60 has a gradually increasing and then gradually decreasing perimeter from the upstream end to the downstream end.

[0229] In the above realization process, by installing the second cover member 60 on the outer peripheral side of the heart valve stent 10, the second cover member 60 abuts against the heart tissue, and further prevents blood backflow. And, since the second cover member 60 has a gradually increasing and then gradually decreasing perimeter from the upstream end to the downstream end, the middle part of the outer periphery of the second cover member 60 abuts against the heart tissue, and the effect of preventing blood backflow is better.

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

[0231] In the above realization process, by installing the first flange 601 at the downstream end of the second cover member 60, the effect of preventing blood backflow is better.

[0232] In some embodiments, a receiving notch 602 is formed in the first flange 601 and the second cover member 60, and the receiving notch 602 is configured to receive the support body 100.

[0233] In the above realization process, by forming the receiving notch 602 for receiving the support body 100 in the first flange 601 and the second cover member 60, the first flange 601 and the second cover member 60 are more closely attached to the support body 100, and it is possible to prevent the backflow of blood between the first flange 601 and the second cover member 60 and the support body 100.

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

[0235] In the above realization process, by providing the second flange 703 on the outer peripheral edge of the second cover member 60, the effect of preventing the backflow of blood is better.

[0236] In some embodiments, the second flange 703 is provided on the outer peripheral edge of the second cover member 60 having the largest perimeter.

[0237] In the above realization process, by providing the second flange 703 on the outer peripheral edge of the second cover member 60 having the largest perimeter, the second flange 703 abuts against the heart tissue, and the effect of preventing the backflow of blood is better.

[0238] The technical solution of the present disclosure has the following effects. 1. The present disclosure provides at least one protruding and extending branch structure connected to the support body, and the protruding and extending branch structure protrudes and extends from the support body to the outside of the flow passage to form a protruding and extending portion that abuts against the heart tissue, so that the risk of displacement of the heart valve stent of the backflow patient can be well reduced. 2. In the present disclosure, a gap for accommodating the native valve leaflet of the heart is formed between the protruding extension and the supporting body, and the native valve leaflet of the heart is accommodated in the gap, whereby the risk of coronary artery blockage after the heart valve stent is attached can be reduced. 3. The heart valve stent according to the present disclosure is woven by a shape memory alloy wire, and a connection ring for connecting to a delivery system is formed, whereby complete recovery of the heart valve stent can be realized. 4. The service life of the heart valve stent according to the present disclosure is longer. 5. The valve leaflet according to the present disclosure is made of a polymer material and can contribute to extending the service life of the valve leaflet. 6. The artificial heart valve according to the present disclosure has a relatively small volume and a lower possibility of causing biocompatibility problems. 7. The valve leaflet according to the present disclosure is uniformly coated on the surface of the heart valve stent using a polymer material, and has a greater adhesive force, which can prevent damage and detachment of the valve leaflet caused by excessive stress during sewing with sutures.

[0239] Other structures and advantages of the present disclosure will be described in the subsequent parts, or some structures and advantages can be inferred from the specification or confirmed without objection, or can be made clear by implementing the above technologies of the present disclosure.

[0240] To make the above objects, structures, and advantages of the present disclosure clearer, the following preferred embodiments will be given and described in detail with reference to the drawings.

[0241] As shown in FIGS. 1, 2, and 6, an embodiment of the present disclosure provides an (artificial) heart valve stent 10. The (artificial) heart valve stent 10 includes a support body 100 and at least one protruding and extending branched 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 and extending branched structure 200 extends from the support body 100 to the outside of the flow passage 120, and a protruding and extending portion 210 capable of abutting against heart tissue is formed. A gap 300 for accommodating the natural valve leaflet of the heart is formed between the protruding and extending branched structure 200 and the support body 100.

[0242] In the above embodiment, the (artificial) heart valve stent 10 includes a support body 100 and at least one protruding and extending branched structure 200 connected to the support body 100. The support body 100 is disposed at the position of the original aortic valve, and a flow passage 120 through which blood flows is defined in the middle portion of the support body 100. The protruding and extending branched structure 200 extends from the support body 100 to the outside spaced apart from the flow passage 120, and a protruding and extending portion 210 capable of abutting against heart tissue (such as the sinus of Valsalva) is formed in the protruding and extending branched structure 200. Thus, when the heart valve stent is disposed at the position of the original aortic valve, the protruding and extending portion 210 abuts against the heart tissue, thereby playing a role in fixing the heart valve stent, and preventing the heart valve stent from being displaced under the action of the pressure of the blood at the valve leaflet when the valve leaflet 20 closes. As a result, the stability and reliability of the placement of the heart valve stent at the position of the original aortic valve can be improved, and the service life of the heart valve stent can be extended. And there is a gap between the protruding and extending branched structure 200 and the support body 100. Thus, when the heart valve stent is attached at the position of the original aortic valve, the natural valve leaflet of the heart is accommodated in the gap, preventing blockage of the coronary artery caused by mutual interference between the natural valve leaflet of the heart and the heart valve stent, and contributing to the improvement of the safety during the attachment of the (artificial) heart valve stent 10.

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

[0244] In the above embodiment, the heart valve stent includes a plurality of support units 110, and the plurality of support units 110 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 ends of the two first support structures 111 respectively. A space that can be covered by the connection of a cover member is formed between the second support structure 112 and the two first support structures 111. When the space is covered by the connection of the cover member, blood can only flow through the flow passage 120, thereby preventing blood from flowing on the outer peripheral side of the heart valve stent.

[0245] Specifically, in one embodiment, the first support structure 111 and the second support structure 112 can be formed by braiding the same braided wire, and the two are continuously formed. For the sake of convenience of description, they are called the first support structure 111 and the second support structure 112. Also, the support unit 110 and the plurality of support units 110 can also be formed by braiding the same braided wire.

[0246] Exemplarily, the number of support units 110 is three, and the three support units 110 form the support body 100.

[0247] As shown in FIGS. 1 and 2, in some embodiments, when the upstream direction and the downstream direction are defined along the direction in which blood flows through the flow 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 where the second support structure 112 is located, a blood outflow end is formed in the direction where the two first support structures 111 are located, blood flows in from the direction where the second support structure 112 is located, and flows out from the direction where the first support structure 111 is located.

[0249] As shown in FIGS. 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 are connected.

[0250] In the above embodiment, the two first support structures 111 have their first ends respectively connected to both ends of the second support structure 112, and their second ends extend downstream in the flow passage 120 and merge and are connected, so that a closed space that can be covered by the connection of the cover member is formed between the two first support structures 111 and the second support structure 112. The second ends of the two first support structures 111 can be connected by riveting or welding.

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

[0252] In the above embodiment, there are a plurality of protruding and extending branch structures 200, and each support unit 110 is connected to a protruding and extending branch structure 200. Specifically, the plurality of protruding and extending branch structures 200 are installed at intervals and are located between two adjacent support units 110 in the circumferential direction of the support main body 100. In this way, when the protruding and extending portions 210 of the plurality of protruding and extending branch structures 200 abut against the heart tissue (for example, the aortic sinus), the reliability and stability of the (artificial) heart valve stent 10 after installation can be effectively improved.

[0253] Specifically, in one embodiment, the protruding extended branching structure 200 and the support unit 110 are formed by braiding with the same braided wire and are formed continuously.

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

[0255] In the above embodiment, the ends of each of the two protruding extended branching structures 200 between two adjacent support units 110, which are located upstream of the flow passage 120, are connected. That is, the two protruding extended portions 210 of the two protruding extended branching structures 200 are connected to each other, which can contribute to improving the reliability and stability when the protruding extended portion 210 abuts against the heart tissue.

[0256] As shown in FIGS. 1 and 2, in some embodiments, the two protruding extended branching structures 200 between two adjacent support units 110 are formed by one braided wire.

[0257] In the above embodiment, the two protruding extended branching structures 200 between two adjacent support units 110 are integrally formed by one braided wire, and no further connection by means such as welding or riveting connection is required, which can contribute to improving the production efficiency of the product.

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

[0259] In the above embodiment, a connection ring 400 is formed on the first support structure 111. The connection ring 400 is located downstream of the flow passage 120 and is connected to the delivery system of the (artificial) heart valve stent 10 to realize the delivery and retrieval of the heart valve stent by the delivery system.

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

[0261] In the above embodiment, there are a plurality of connection rings 400, and all of the plurality of connection rings 400 are located downstream of the flow passage 120. If the plurality of connection rings 400 are connected to the delivery system of 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 FIGS. 1 and 2, in some embodiments, a first riveting structure 114 is provided at a position upstream of the connection ring 400, and the connection ring 400 is formed as a closed ring by the first riveting structure 114.

[0263] In the above embodiment, by installing the first riveting structure 114 at a position upstream of the connection ring 400, the connection ring 400 is formed as a closed ring structure, which contributes to the connection between the connection member of the delivery system and the connection ring 400, and can contribute to improving the certainty of the connection between the connection member of the delivery system and the connection ring 400.

[0264] As shown in FIGS. 1 and 2, in some embodiments, each support unit 110 and its adjacent support unit 110 are connected by a riveting structure to form a second riveting structure 115. In the second riveting structure 115, 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 native valve leaflets of the heart is formed between the protruding extension branching structure 200 and the first support structure 111 and the second support structure 112 in the second riveting structure 115.

[0265] In the above-described embodiment, each support unit 110 and two adjacent support units 110 are connected by a rivet structure, that is, the connection points of the two first support structures 111 and the second support structure 112 of each support unit 110, and the connection points of 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 joint structure 115. In the first rivet joint structure 114, the first support structures 111 and the second support structures 112 of two adjacent support units 110 are arranged in parallel, thereby contributing to improving the certainty of connection of each support unit 110, improving the aesthetic appearance of the product, and the protruding extension branch structure and the first support structure 111 and the second support structure 112 in the second rivet joint structure 115 are installed at intervals, defining a gap for accommodating the self-valve tip of the heart.

[0266] As shown in FIGS. 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 joint structure 116.

[0267] In the above-described embodiment, the connection points of the two first support structures 111 of each support unit 110, which are located downstream of the flow passage 120, are connected by a rivet structure such as a rivet tube to form a third rivet joint structure 116, thereby effectively ensuring the reliable connection of the ends of the two first support structures 111 of each support unit 110, which are located downstream of the flow passage 120.

[0268] As shown in FIGS. 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 continuous protruding extension segments 220 and connection segments 230. The protruding extension segments 220 bend and extend in a direction away from the flow passage 120, and one end of the connection segment 230 is connected to the protruding extension segment 220, and the other end is connected to the support body 100. The angle formed by the protruding extension segment 220 and the axial direction of the flow passage 120 is 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 between the protruding extension segment 220 and the axial direction of the flow passage 120 to be 1° to 150°, 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 the improvement of the stability when the protruding extension segment 220 abuts against the heart tissue.

[0270] Specifically, a mounting space for passing 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 100 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 at least one elongated material.

[0274] In the above embodiment, by way of example, the elongated material is a shape memory alloy wire, a nickel-titanium alloy wire, or the like. When the (artificial) heart valve stent 10 is woven from a single elongated material, its integrity is relatively high and it can contribute to processing and shaping. When the heart valve stent is woven from a plurality of elongated materials, the two connected elongated materials can be fixedly connected by connection with a rivet tube or welding. Also, the connection points of the 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 from 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 removed. After deforming the shape memory alloy wire with an external force, the artificial valve stent can be easily inserted by a delivery system. After the artificial valve stent is inserted into 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 at the location of the aortic valve. When the (artificial) heart valve stent 10 is woven from a plurality of shape memory alloy wires, the 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 from 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 formed by braiding with a shape memory alloy wire having a diameter change, or a shape memory alloy tube 500 is looped around a part of the outer periphery of the second support structure 112, so that the diameter of a part of the second support structure 112 is increased, 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 FIG. 6, in the second aspect, the embodiment of the present disclosure provides a heart artificial valve. The heart artificial valve includes any one of the (artificial) heart valve stents 10 according to the embodiment of the first aspect, a valve tip 20 provided in the flow passage 120 and connected to the first support structure 111 of the (artificial) heart valve stent 10, and 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 so as to surround the outer peripheral side of the (artificial) heart valve stent 10.

[0281] In the above embodiment, the valve tip 20 is located in the flow passage 120 and connected to the first support structure 111 of the heart valve stent, and the flow of blood can be controlled by the opening and closing of the valve tip 20. For example, when the heart contracts, the valve tip 20 opens to send the blood in the heart to the whole body through the aorta, and when the heart relaxes, the valve tip 20 closes in time to prevent the blood in the aorta from returning to the ventricle. The 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 peripheral side of the heart valve stent and ensuring that blood flows in from the blood inflow end and flows out from the blood outflow end. The second sealing cover member 40 is installed so as to surround the outer peripheral side of the (artificial) heart valve stent 10 and is configured to prevent blood backflow and prevent perivalvular backflow.

[0282] As shown in FIG. 6, in some embodiments, the second sealing cover member 40 is in a disc shape, 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 FIGS. 7 to 9, FIG. 7 is a schematic configuration diagram of the heart valve stent 10 according to some embodiments of the present disclosure, FIG. 8 is a schematic configuration diagram of the heart valve stent 10 according to some embodiments of the present disclosure as viewed from another angle, and FIG. 9 is a schematic enlarged configuration diagram of a portion A in FIG. 8. Embodiments of the first aspect of the present disclosure provide a heart valve stent 10. The heart valve stent 10 is formed by braiding at least one elongated material into a defined shape, and a flow passage 120 through which blood flows is defined in the heart valve stent 10. At least one elongated material protrudes and extends outside the flow passage 120 to form a protruding and extending portion 210 that can abut against the heart tissue.

[0284] The heart valve stent 10 according to the embodiment of the present disclosure is disposed at the position of the original aortic valve. The heart valve stent 10 is formed by braiding at least one elongated material into a defined shape, and a flow passage 120 through which blood flows is defined in the middle portion of the heart valve stent 10. Exemplarily, the elongated material is a shape memory alloy wire or a nickel-titanium alloy wire, etc. By a part of at least one elongated material protruding and extending outwardly spaced from the flow passage 120, a protruding and extending portion 210 that can abut against the heart tissue (for example, the sinus of Valsalva) is formed. Thus, when the heart valve stent 10 is disposed at the position of the original aortic valve, the protruding and extending portion 210 abuts against the heart tissue, which serves to fix the heart valve stent 10 and can prevent the heart valve stent 10 from being displaced under the action of the pressure of the blood at the valve tip 20 when the valve tip 20 closes. Accordingly, the stability and reliability of the arrangement of the heart valve stent 10 at the position of the original aortic valve can be improved, the service life of the heart valve stent 10 can be extended, and it can contribute to the improvement of the stability of the heart valve stent 10 used in patients without calcification.

[0285] As shown in FIGS. 7 and 8, in some embodiments, the heart valve stent 10 includes a plurality of support units 110, and the plurality of support units 110 define and form a flow passage 120. Each support unit 110 includes two first support structures 111 for connecting to different valve tips 20 respectively, and a second support structure 112 connecting the two first support structures 111. A space that can be covered by the connection of a cover member is formed between the two first support structures 111 and the second support structure 112.

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

[0287] As shown in FIGS. 7 and 8, in some embodiments, when the upstream direction and the downstream direction are defined along the direction in which blood flows through the flow 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 inlet end is formed in the direction where the second support structure 112 is located, and a blood outlet end is formed in the direction where the two first support structures 111 are located. Blood flows in from the direction where the second support structure 112 is located and flows out from the direction where the first support structure 111 is located.

[0289] As shown in FIGS. 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 two first support structures 111 are such that the first ends are respectively connected to both ends of the second support structure 112, extend in the downstream direction of the flow passage 120, and the second ends of the two first support structures 111 are connected to each other, thereby forming a closed space between the second support structure 112 that can be covered by the connection of the cover member. The second ends of the two first support structures 111 are connected by a method such as connection by a rivet tube, welding, or adhesion. Further, the two first support structures 111 and the second support structure 112 can be integrally connected, that is, they are different parts formed by braiding the same elongated material into a specified shape.

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

[0292] In the above embodiment, the support unit 110 further includes a third support structure 113, and the third support structure 113 forms a connection ring 400 located downstream of the heart valve stent 10. The connection ring 400 is connected to the delivery system of the heart valve stent 10, and the delivery and retrieval of the heart valve stent 10 are realized by the delivery system.

[0293] Each support unit 110 has two third support structures 113, and the ends of the two third support structures 113 located downstream of the heart valve stent 10 are respectively connected to the second ends of the two first support structures 111 after forming the connection ring 400. The connection here may include mechanical connections such as welding, adhesion, and rivet connection, and both may represent the extension 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, after the end of the third support structure 113 located downstream of the heart valve stent 10 forms the connection ring 400, it is 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.

[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 FIGS. 7 and 8, in some embodiments, the protruding extension 210 of each support unit 110 and the protruding extension 210 of its adjacent support unit 110 are formed by bending the same elongated material, and the two adjacent protruding extensions 210 are continuously formed.

[0300] In the above embodiment, the two adjacent protruding extensions 210 in two adjacent support units 110 are continuous and formed by bending the same elongated material, preventing the heart tissue from being damaged by the protruding extension 210 due to stress concentration, and further improving the support strength of the protruding extension 210 and the reliability of the installation of the heart valve stent.

[0301] As shown in FIGS. 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 connection structure 114. In the first rivet connection structure 114, each elongated material is arranged in parallel, and the protruding extension 210 is located in the middle.

[0302] In the above embodiment, each support unit 110 and its two adjacent support units 110 are connected by a rivet structure, that is, the connection points of the two first support structures 111 and the second support structure 112 of each support unit 110, and the connection points of the two first support structures 111 and the second support structure 112 of its adjacent support unit 110 are connected by a rivet structure to form two first rivet connection structures 114, and the third support structure 113 is also connected to the first rivet connection structure 114. In the first rivet connection structure 114, each elongated material is arranged in parallel, thereby contributing to improving the certainty of the connection of each support unit 110, improving the aesthetics of the product, contributing to the contraction and expansion of the heart valve stent 10, and the protruding extension 210 of each support unit 110 is located in the middle of the support unit 110, contributing to contacting the heart tissue.

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

[0304] In the above embodiment, the connection points of the two first support structures 111 of each support unit 110, which are located downstream of the flow passage 120, are connected by a rivet structure such as a rivet tube 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, and reliable connection between the two first support structures 111 and the two third support structures 113 in each support unit 110 can be effectively ensured.

[0305] The rivet connection according to any one of the above embodiments includes binding a plurality of members by one binding member (generally, a metal member).

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

[0307] In the above embodiment, by setting the angle formed between the plane where the protruding extension 210 is located and the direction perpendicular to the axial direction of the flow passage 12 to 15° to 90°, when the heart valve stent 10 is disposed at the position of the original aortic valve, the protruding extension 210 contributes to abutting against the heart tissue corresponding to the position of the heart tissue, and can contribute to improving the stability of the abutment between the protruding extension 210 and the heart tissue.

[0308] As shown in FIG. 9, in some embodiments, along the direction in which blood flows through the flow passage 120, the third support structure 113 includes continuous protruding extension segments 220, transition segments 240, and connection segments 230. The protruding extension segments 220 form protruding extensions 210. One end of the transition segment 240 is connected to the protruding extension segment, and the other end bends and extends in a direction away from the flow passage 120, and the angle formed between the direction perpendicular to the axial direction of the flow passage 120 is 60° to 150°. One end of the connection segment 230 is connected to the transition segment 240, and the other end is connected to the first support structure 111.

[0309] In the above embodiment, the third support structure 113 includes 10131, a transition segment 240, and a connection segment 230 that are sequentially connected along the flow direction of the flow passage 120. The protruding extension segment 220 forms a protruding extension 210 that protrudes and extends outside the flow passage 120 and can contact the heart tissue. One end of the transition segment 240 is connected to the protruding extension segment 220, and the other end bends and extends in a direction away from the flow passage 120. The angle formed between the transition segment 240 and the direction perpendicular to the axial direction of the flow passage 120 is 60° to 150°. Thereby, the original aortic valve location can be expanded by the heart valve stent 100 to ensure normal blood flow. One end of the connection segment 230 is connected to the transition segment 240, and the other end bends and extends in a direction close to the first support structure 111 and forms a connection ring 400 at the most downstream location of the flow passage 120 and then is connected to the first support structure 111. Thereby, a relatively large space is formed between the third support structure 113 and the valve tip 20, and when a coronary artery stent is implanted in the patient, the coronary artery stent can be attached using this space.

[0310] Exemplarily, the protruding extension segments 220, transition segments 240, and connection segments 230 of the third support structure 113 are integrally connected, that is, they are formed by braiding the same elongated material into a specified shape.

[0311] Referring to FIGS. 6 and 10, FIG. 10 is a schematic configuration diagram of a heart valve prosthesis 100 according to some embodiments of the present disclosure. In addition to the structure of the heart valve prosthesis 100 shown in FIG. 6 above, the second sealing cover member 40 is installed so as to surround the outer peripheral side of the first sealing cover member 30 and is sealingly connected to the first sealing cover member 30.

[0312] In the above embodiment, the valve leaflet 20 is located within the flow passage 120 and is connected to the heart valve stent 10. The opening and closing of the valve leaflet 20 can control the blood flow. For example, when the heart contracts, the valve leaflet 20 opens to send the blood in the heart to the whole body through the aorta, and when the heart relaxes, the valve leaflet 20 closes in a timely manner to prevent the blood in the aorta from returning to the ventricle. The first sealing cover member 30 is installed in the space formed between the two first support structures 111 and the second support structures 112 of each support unit 110 of the heart valve stent 10, thereby preventing the blood from flowing on the outer peripheral side of the heart valve stent 10 and ensuring that the blood flows in from the blood inflow end and flows out from the blood outflow end. A second sealing cover member 40 that surrounds the outer peripheral side of the first sealing cover member 30 and is sealingly connected to the first sealing cover member 30 is further installed. The second sealing cover member 40 blocks the backflow of blood and prevents perivalvular backflow.

[0313] As shown in FIG. 10, in some embodiments, the second sealing cover member 40 is in a disk shape, 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 FIGS. 11, 12, and 16, an embodiment of the first aspect of the present disclosure provides an implantable heart valve stent 10. The implantable heart valve stent 10 includes a plurality of support units 110, and a flow passage 120 through which blood flows is defined and formed by the plurality of support units 110. At least one support unit 110 includes a protruding and extending branch structure 200, and a protruding and extending portion 210 that protrudes and extends in a direction away from the flow passage 120 and can abut against heart tissue is formed. And the protruding and extending branch structure 200 extends in the upstream direction of the flow passage 120 to form a connection 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, and the plurality of support units 110 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 and extending branch structure 200, and a protruding and extending portion 210 that protrudes and extends in a direction away from the flow passage 120 and can abut against heart tissue is formed. Thus, when the heart valve stent is disposed at the position of the original aortic valve, the protruding and extending portion 210 abuts against the heart tissue, thereby playing a role in fixing the heart valve stent and preventing the heart valve stent from being displaced under the action of the pressure of the blood at the valve tip 20 when the valve tip 20 closes. Thereby, the stability and reliability of the arrangement of the heart valve stent at the position of the original aortic valve can be improved, and the service life of the heart valve stent can be extended. And the protruding and extending portion 210 extends upstream of the flow passage 120 to form a connection structure 250 that can be connected to a sealing cover member. After the sealing cover member and the connection structure 250 are connected, it is possible to prevent blood from flowing on the outer peripheral side of the flow passage 120 and improve the fluidity when blood flows along the axial direction of the flow passage 120.

[0316] Specifically, in the case of a patient with relatively severe calcification of the valve tip 20, the protruding extension 210 directly abuts against the calcified valve tip of the patient. Since the hardness of the calcified valve tip 20 is relatively large, when the protruding extension 210 abuts against the calcified valve tip 20, it can play a good supporting role, ensuring the reliability and stability when the heart valve stent is placed at the original location of the heart valve.

[0317] Specifically, in one embodiment, the protruding extension branch structure 200 and the support unit 110 can be formed by braiding with the same braided wire, and the two are continuously formed. For the sake of convenience of explanation, they are referred to as the protruding extension branch structure 200 and the support unit 110. Also, each support unit 110 and a plurality of support units 110 can also be formed by braiding with the same braided wire.

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

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

[0320] As shown in FIGS. 11 and 12, in some embodiments, when the upstream direction and the downstream direction are defined along the direction in which the blood flows through the flow passage 120, the connection structure 250 is located upstream of the two first support structures 111 and is continuously formed with the end of the protruding extension branch structure 200 located upstream of the flow passage 120.

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

[0322] As shown in FIGS. 14 and 15, in some embodiments, the connection structure 250 includes at least one sub-connection structure 251, and at least one sub-connection structure 251 is installed overlapping or spaced apart from the connection structure 250.

[0323] In the above-described embodiment, at least one sub-connection structure 251 is connected to the connection structure 250, and at least one sub-connection structure 251 is installed overlapping or spaced apart from the connection structure 250, so that the support strength when the connection structure 250 is supported at the location of the original heart valve can be increased, and the stability during the installation of the heart valve stent can be improved.

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

[0325] In the above-described embodiment, the two first support structures 111 are respectively connected to both ends of the connection structure 250 at the first ends, the second ends extend downstream in the flow passage 120, and are merged and connected, so that a closed space that can be covered by the connection of the cover member is formed between the connection structure 250.

[0326] Exemplarily, as the connection method of the second ends of the two first support structures 111 and the connection method between the two first support structures 111 and the connection structure 250, they can be connected by rivet pipes or welding.

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

[0328] In the above embodiments, there are a plurality of protruding and extending branch structures 200, and each support unit 110 includes a protruding and extending branch structure 200. Specifically, the plurality of protruding and extending branch structures 200 are installed at intervals and are located between two adjacent support units 110 in the circumferential direction of the support body. In this way, by the protruding and extending parts 210 of the plurality of protruding and extending branch structures 200 abutting against the heart tissue (for example, the calcified valve tip), the reliability and stability of the heart valve stent after installation can be effectively improved.

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

[0330] In the above embodiments, the connection structures 250 formed by the two protruding and extending branch structures 200 of each support unit 110 are connected to each other (for example, integral connection, welding or rivet connection, etc.), which can contribute to the improvement of stability when covering the space formed between the connection structure 250 and the first support structure 111 by the connection of the sealing cover member, can contribute to the improvement of the integrity of the product, and can improve the reliability and stability when the heart valve stent is arranged at the original heart valve location.

[0331] As shown in FIGS. 11 and 12, in some embodiments, a second space 600-B for passing a medical device 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 for passing a medical device such as a coronary stent is formed between each protruding extension branch structure 200 and the first support structure 111 connected thereto. Thereby, after the heart valve stent is attached, a medical device such as a coronary stent can be easily attached.

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

[0334] In the above embodiment, the protruding extension branch structure 200 and the first support structure 111 are formed by braiding with a single braided wire, and since these two structures are continuously formed, further connection by a method such as welding or riveting connection is unnecessary, which can contribute to the improvement of the production efficiency of the product and the improvement of the integrity of the product.

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

[0336] In the above embodiment, a connection ring 400 is installed on the protruding extension branch structure 200. The connection ring 400 is located downstream of the flow passage 120 and is connected to the delivery system of the implantable heart valve stent 10 to realize the delivery and retrieval of the heart valve stent by the delivery system.

[0337] As shown in FIGS. 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 joint structure 114. In the first rivet joint structure 114, the first support structure 111 and the connection structure 250 of two adjacent support units 110 are parallel, and the end of the protruding extension branch structure 200 located upstream of the flow passage 120 is located in the first rivet joint structure 114.

[0338] In the above embodiment, each support unit 110 and its 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 connection structure 250 of each support unit 110, and the connection points between the two first support structures 111 and the connection structure 250 of its adjacent support unit 110 are connected by a rivet structure to form a first rivet joint structure 114. In the first rivet joint structure 114, the first support structure 111 and the connection structure 250 of two adjacent support units 110 are parallel. Thereby, it can contribute 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 joint structure 115 and is continuously formed with the connection structure 250.

[0339] As shown in FIGS. 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 joint structure 115.

[0340] In the above embodiment, the connection points of 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 tube to form a second rivet joint structure 115. Thereby, it can effectively ensure the reliable connection of 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 FIGS. 11, 12, and 13, in some embodiments, the protruding and extending branch structure 200 includes a first connection segment, an abutting segment, and a second connection segment that are connected in sequence. The first connection segment is connected to the first rivet connection structure 114. The abutting segment has a first end connected to the first connection segment and a second end that protrudes and extends in a direction away from the flow passage 120. The second connection segment has one end connected to the second end of the abutting segment and the other end connected to the first support structure 111.

[0342] In the above embodiment, the protruding and extending branch structure 200 includes a first connection segment, an abutting segment, and a second connection segment that are connected in sequence. At least a part of the first connection segment is located in the first rivet connection structure 114 and is continuously formed with the connection structure 250. The abutting segment has a first end connected to the first connection segment and a second end that protrudes and extends outside the flow passage 120 to form a protruding and extending portion 210 that can abut against the heart tissue. The second connection segment has one end connected to the abutting segment and the other end that extends in a direction close to the flow passage 120 and is connected to the first support structure 111.

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

[0344] In the above embodiment, by setting the angle α formed between the abutting segment and the axial direction of the flow passage 120 to 10° to 150°, it can contribute to the abutting of the abutting segment against the heart tissue (for example, the calcified valve leaflet), and can contribute to the improvement of the stability when the abutting segment abuts against the heart tissue.

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

[0346] In the above-described embodiment, the first connection segment is connected to the first rivet connection structure 114 along the axial direction of the flow passage 120. By setting the distance b between the second end of the abutting segment and the first connection segment to be 1 mm to 20 mm, on the one hand, it can be ensured that the abutting segment abuts against the heart tissue, and on the other hand, it can be prevented that the abutting segment protrudes and extends excessively outside the flow passage 120 to damage the heart tissue.

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

[0348] In the above-described embodiment, illustratively, the braided wire is a shape memory alloy wire or a nickel-titanium alloy wire, etc. When the heart valve stent is formed by braiding with one braided wire, the integrity of the heart valve stent is relatively high and can contribute to processing and forming. When the heart valve stent is formed by braiding with a plurality of elongated materials, the two connected elongated materials can be fixedly connected by connection with a rivet tube or welding. Also, the connection points of the two connected elongated materials can be fixedly connected by welding or screw connection.

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

[0350] In the above-described embodiment, the heart valve stent is formed by braiding with 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. After deforming the shape memory alloy wire with an external force, the implantable heart valve stent 10 can be easily fed into a delivery system. After the artificial valve stent is fed into 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 installed at the location of the aortic valve.

[0351] In some embodiments, the connection structure 250 is formed by braiding with a shape memory alloy wire having a diameter change, or a shape memory alloy tube is annularly installed on a part of the outer periphery of the connection structure 250.

[0352] In the above embodiment, the connection structure 250 is formed by braiding with a shape memory alloy wire having a diameter change, or a shape memory alloy tube is annularly installed on a part of the outer periphery of the connection structure 250, so that the diameter of a part of the connection structure 250 can be increased, 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 FIG. 16, an embodiment of the second aspect of the present disclosure provides a heart artificial valve. The heart artificial valve includes any one implantable heart valve stent 10 according to the embodiment of the first aspect, a valve tip 20 provided in the flow passage 120 and connected to the first support structure 111 of the implantable heart valve stent 10, and a first sealing cover member 30 configured to cover the space formed between the two first support structures 111 of the heart valve stent and the connection structure 250 by connection, and a second sealing cover member 40 installed so as to surround the outer peripheral side of the implantable heart valve stent 10.

[0354] In the above embodiment, the valve tip 20 is located in the flow passage 120 and connected to the first support structure 111 of the heart valve stent. The opening and closing of the valve tip 20 can control the blood flow. For example, when the heart contracts, the valve tip 20 opens to send the blood in the heart to the whole body through the aorta, and when the heart relaxes, the valve tip 20 closes in time to prevent the blood in the aorta from returning to the ventricle. The first sealing cover member 30 is installed in the space formed between the two first support structures 111 of each support unit 110 of the heart valve stent and the connection structure 250, thereby preventing the blood from flowing on the outer peripheral side of the heart valve stent and ensuring that the blood flows in from the blood inflow end and flows out from the blood outflow end. The second sealing cover member 40 is installed so as to surround the outer peripheral side of the heart valve stent 10 and is configured to prevent the backflow of blood and prevent the perivalvular backflow.

[0355] In some embodiments, the connection method between the valve tip 20 and the first support structure 111 of the heart valve stent is one of adhesion, hot melt, and polymer adhesion.

[0356] In the above embodiments, the second sealing cover member 40 has a disk shape. Thus, when the heart valve stent is disposed at the position of the original aortic valve, the second sealing cover member 40 abuts against the original heart valve tissue, and the outer peripheral edge portion of the second sealing cover member 40 is bent in the downstream direction of the heart valve stent to form a protruding edge. In this way, when the valve tip 20 closes, blood can only flow upward from the valve tip 20 to above the second sealing cover member 40, flows above the second sealing cover member 40, effectively preventing the backflow of blood and preventing the circumferential backflow of the valve.

[0357] In some embodiments, the material of the valve tip 20 is one of a polymer material, a biological tissue material, and a tissue engineering material.

[0358] In the above embodiments, by way of example, the material of the valve tip 20 is materials such as bovine pericardium, porcine pericardium, bovine / porcine heart valves, and the like.

[0359] In some embodiments, the connection method between the valve tip 20 and the first support structure 111 of the (artificial) heart valve stent 10 is one of adhesion, hot melt, and polymer adhesion.

[0360] In the above embodiments, the valve tip 20 is fixedly connected to the first support structure 111 of the (artificial) heart valve stent 10 by one of the methods of adhesion, hot melt, and polymer adhesion, preventing damage and detachment of the valve tip 20 caused by stress concentration, and contributing to the improvement of the service life of the product.

[0361] Referring to FIGS. 17 to 19, FIG. 17 is a schematic perspective configuration diagram of a heart valve stent according to an embodiment of the present disclosure, FIG. 18 is a schematic perspective configuration diagram of the heart valve stent viewed from another angle according to an embodiment of the present disclosure, and FIG. 19 is a schematic perspective configuration diagram of the heart valve stent, valve tip, 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 and extending branch structure 200. The support body 100 includes a plurality of support units 110, and a passage 101 through which blood flows is defined and formed by the plurality of support units 110. Each support unit 110 includes two first support structures 111 for connecting to different valve tips 20 respectively. At least one support unit 110 includes a second support structure 112, and the second support structure 112 is provided on the side of the first support structure 111 closer to its adjacent support unit 110. The protruding and extending branch structure 200 is relatively fixed to two adjacent support units 110 and extends from the support body 100 to the outside of the passage 101, and a gap (not shown) for accommodating the heart's own valve tip is formed between the protruding and extending branch structure 200 and the support body 100.

[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 through the passage 101 more smoothly, and the blood flow rate is not impaired. By installing the protruding and extending branch structure 200 that contacts the heart tissue, the heart's own valve tip is accommodated between the protruding and extending branch structure 200 and the support body 100. As a result, after the heart valve stent 10 is implanted in the heart, it is more difficult to come off and becomes stronger, the service life of the heart valve stent 10 can be extended, and the risk of the patient's valve being replaced again can be reduced.

[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 configuration, is easy to manufacture, and has a relatively strong structure.

[0364] In other embodiments, the support body 100 may be composed of two support units 110 or more than three support units 110, which is not limited herein.

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

[0366] By installing the two first support structures 111 and respectively installing the two second support structures 112 on both sides 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 the two first support structures 111, and a space covered by the connection of the first cover member 50 is formed between the two first support structures 111 and the third support structure 113.

[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, and backflow of blood can be prevented.

[0369] In some embodiments, each first support structure 111 is relatively fixed to one protruding and extending branch structure 200 respectively, and each protruding and extending branch structure 200 is relatively fixedly connected to two adjacent first support structures 111 belonging to two adjacent support units 110 respectively, and an intermediate portion of the protruding and extending branch structure 200 forms a protruding and extending portion 210 for abutting against the heart tissue.

[0370] By connecting two adjacent first support structures 111 adjacent to each protruding and extending branch structure 200, it serves to connect and fix two adjacent support units 110, making the overall structure of the support body 100 more stable. By forming a protruding and extending portion 210 by the middle portion of the protruding and extending branch structure 200, contact with the heart tissue can be realized, and the heart valve stent 10 can be placed more stably at a predetermined position of the heart.

[0371] In some embodiments, two adjacent second support structures 112 belonging to each of two adjacent support units 110 are located between the protruding and extending branch structures 200 connecting these two support units 110 along the circumferential direction of the heart valve stent 10.

[0372] By the fact that two adjacent second support structures 112 belonging to each of two adjacent support units 110 are located between the protruding and extending branch structures 200 connecting these two support units 110 along the circumferential direction of the heart valve stent 10, the second support structure 112 can play a better supporting role, reducing the problem of being prone to deformation caused by an excessive interval between two adjacent first support structures 111 of two adjacent support units 110, and making the structure of the heart valve stent 10 stronger.

[0373] In some embodiments, two adjacent second support structures 112 belonging to each of two adjacent support units 110 are located inside the protruding and extending branch structures 200 connecting these two support units 110 along the radial direction of the heart valve stent 10.

[0374] Two adjacent second support structures 112, each belonging to two adjacent support units 110, are located inside a protruding and extending branch structure 200 that connects these two support units 110 along the radial direction of the heart valve stent 10. As a result, the second support structure 112 can play a better supporting role and strengthen the structure of the heart valve stent 10. A gap for accommodating the self-valve leaflet of the heart is formed between the protruding and extending branch structure 200 and the support body 100, which contributes to the contact of the protruding and extending branch structure 200 with the heart tissue and enables the heart valve stent 10 to be more stably arranged at a predetermined position in the heart.

[0375] In some embodiments, a downstream portion of two first support structures 111 of the support unit 110 and a downstream portion of two protruding and extending branch structures 200 are connected by a rivet structure to form a first riveted joint structure 114, and these two protruding and extending branch structures 200 are two protruding and extending branch structures that are relatively fixed to these two first support structures 112.

[0376] By connecting the first support structure 111 and the protruding and extending branch structure 200 with a rivet structure, the structures of the first support structure 111 and the protruding and extending branch structure 200 are less likely to deform and become stronger, and the overall structure of the heart valve stent 10 becomes stronger.

[0377] In some embodiments, an upstream portion of two adjacent first support structures 111, each belonging to two adjacent support units 110, an upstream portion of two adjacent second support structures 112, and a downstream portion of two adjacent third support structures 113 are connected by a rivet structure to form a third riveted joint 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 are less likely to deform and become stronger, and the overall structure of the heart valve stent 10 becomes stronger.

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

[0380] By braiding with one braided wire 131 to form one support unit 110, it can contribute to the production of the support unit 110, eliminate the need for other connection structures, and simplify and strengthen the structure of the support unit 110. By forming the protruding extension branching structure 200 with another braided wire 131, the production is simpler, and it contributes to forming a gap for accommodating the self-valve tip of the heart between the protruding extension branching structure 200 and the support main body 100, enabling the protruding extension branching structure 200 to contact the heart tissue.

[0381] In some embodiments, the braided wire 131 includes a diameter change portion, the diameter of the diameter change portion is larger than the diameter of other portions, and the diameter change portion is provided corresponding to the rivet structure.

[0382] By providing the diameter change portion of the braided wire 131 corresponding 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 connection structure or come out of the rivet connection structure, and making the rivet connection stronger.

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

[0384] By forming the diameter change portion 132 with the shape memory alloy wire with a diameter change as the braided wire 131, when braiding with the shape memory alloy wire with a diameter change to form the support unit 110 or the protruding extension branching structure 200, the diameter change portion directly corresponds to the position of the rivet connection. Furthermore, the diameter change portion 132 can be connected by a rivet connection member, simplifying the attachment process of the rivet structure.

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

[0386] By winding a shape memory alloy tube around the outer periphery of the braided wire 133 to form the diameter change portion 134, when forming the support unit 110 or the protruding extension branch structure 200 by braiding with the braided wire 133, it is not necessary to consider the position of the diameter change portion 134. After the support unit 110 or the protruding extension branch structure 200 can be braided, the shape memory alloy tube can be installed at the rivet connection location to form the diameter change portion 134 for rivet connection, and the braiding manufacturing process of the support unit 110 can be simplified.

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

[0388] By forming the connection ring 400 downstream of the support unit 110, the support unit 110 can be formed by braiding with one braided wire 131, and the connection ring 400 is difficult to deform. Therefore, the first support structure 111 and the second support structure 112 are also difficult to deform, and the structure of the support unit 110 becomes stronger.

[0389] Referring to FIGS. 22 and 23, FIG. 22 is a schematic perspective configuration diagram of another heart valve stent according to an embodiment of the present disclosure, and FIG. 23 is a schematic perspective configuration diagram of the other heart valve stent viewed from another angle according to an embodiment of the present disclosure. The heart valve stent 10 includes a support main body 800 and at least one protruding extension branch structure 900. Since the configuration of the support main body 800 is similar to the configuration of the support main body 100 in the above heart valve stent 10, the description is omitted here.

[0390] This embodiment is different from the above embodiment in the following points. Each second support structure 812 is fixedly opposed to one protruding and extending branching structure 900, and an intermediate portion of the protruding and extending branching structure 900 forms a protruding and extending portion 910 for abutting against the heart tissue.

[0391] By connecting each protruding and extending branching structure 900 to one second support structure 812, it serves to connect and fix two adjacent support units 810, and the overall structure of the support body 800 is more stable. By forming the protruding and extending portion 910 by the intermediate portion of the protruding and extending branching structure 900, abutment with the heart tissue is realized, and the heart valve stent 10 can be arranged more stably at a predetermined position of the heart.

[0392] In some embodiments, a part of two adjacent second support structures 812 belonging to each of two adjacent support units 810 is located between the protruding and extending branching structures 900 connecting these two support units 810 along the circumferential direction of the heart valve stent 10.

[0393] A part of two adjacent second support structures 812 belonging to each of two adjacent support units 810 is located between the protruding and extending branching structures 900 connecting these two support units 810 along the circumferential direction of the heart valve stent 10, whereby the second support structure 812 can better play the role of support, reduce the problem of being prone to deformation caused by an excessive interval inside the protruding and extending branching structure 900, and can make the structure of the heart valve stent 10 stronger.

[0394] In some embodiments, a part of two adjacent second support structures 812 belonging to each of two adjacent support units 810 is located inside the protruding and extending branching structures 900 connecting these two support units 810 along the radial direction of the heart valve stent 10.

[0395] A part of two adjacent second support structures 812 belonging to each of two adjacent support units 810 is located inside a protruding and extending branch structure 900 that connects to these two support units 810 along the radial direction of the heart valve stent 10. As a result, the second support structure 812 can play a better supporting role and strengthen the structure of the heart valve stent 10. A gap for accommodating the self-valve leaflet of the heart is formed between the protruding and extending branch structure 900 and the support body 800, which contributes to the contact of the protruding and extending branch structure 900 with the heart tissue and enables the heart valve stent 10 to be more stably arranged at a predetermined position of 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 joint structure 814, and the downstream portion of the protruding and extending branch structure 900 and the second support structure 400 are connected by a rivet structure to form a second rivet joint structure 815.

[0397] By using the rivet structure to connect the two first support structures 811 of the support unit 810 and to connect the protruding and extending branch structure 900 and the second support structure 812, the structures of the first support structure 811, the protruding and extending branch structure 900, and the second support structure 812 are less likely to be deformed and become stronger, and the overall structure of the heart valve stent 10 becomes stronger.

[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 rivet joint structure 816.

[0399] By using the rivet structure to connect the first support structure 811, the second support structure 812, and the third support structure 813, the structures of the first support structure 811, the second support structure 812, and the third support structure 313 are less likely to be deformed and become stronger, and the overall structure of the heart valve stent 10 becomes stronger.

[0400] Referring to FIGS. 24 and 19, FIG. 24 is a schematic configuration 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 tip 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 a space formed between two first support structures 111 and a third support structure 113 of a support unit 110 of the heart valve stent 10 by connection.

[0401] By installing the first support structure 111 and the second support structure 112 to form a support main body 100, the structure of the support main body 100 becomes stronger, the passage 101 is less likely to deform, and by installing a protruding extension branch structure 200 that abuts against the heart tissue, the heart valve stent 10 is less likely to come out after being implanted in the heart and becomes stronger, the service life of the heart valve stent 10 can be extended, and the risk of replacing the patient's valve again can be reduced. By installing the valve tip 20 and the first cover member 50, blood flows from the upstream to the downstream of the support main body 100 and no backflow occurs.

[0402] FIG. 25 is a schematic perspective configuration diagram 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 installed so as to surround the outer peripheral side of the heart valve stent 10, the upstream end of the second cover member 60 is connected to the first cover member 50, and the second cover member 60 has a gradually increasing and then gradually decreasing perimeter from the upstream end to the downstream end.

[0403] By installing the second cover member 60 on the outer peripheral side of the heart valve stent 10, the second cover member 60 can abut against the heart tissue and further prevent blood backflow. And because the perimeter of the second cover member 60 gradually increases and then gradually decreases from the upstream end to the downstream end, the middle part of the outer periphery of the second cover member 60 abuts against the heart tissue, and the effect of preventing blood backflow is better.

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

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

[0406] In some embodiments, a receiving notch 602 is formed in the first flange 601 and the second cover member 60, and the receiving notch 602 is configured to receive the support body 100.

[0407] By forming the receiving notch 602 for receiving the support body 100 in the first flange 601 and the second cover member 60, the first flange 601 and the second cover member 60 are more closely attached to the support body 100, and blood backflow between the first flange 601 and the second cover member 60 and the support body 100 can be prevented.

[0408] FIG. 26 is a schematic perspective configuration diagram of a second cover member in another artificial heart valve according to an embodiment of the present disclosure. In some embodiments, a first flange 701 is formed at the downstream end of the second cover member 70, a receiving notch 702 is formed in the first flange 701 and the second cover member 70, an annular second flange 703 is further formed at the outer peripheral edge of the second cover member 70, and the second flange 703 is formed toward the downstream of the heart valve stent 10.

[0409] By installing the second flange 703 at the outer peripheral edge of the second cover member 70, the second flange 703 abuts against the heart tissue, and the effect of preventing blood backflow is better.

[0410] In some embodiments, the second flange 703 is provided at the outer peripheral edge of the second cover member 70 having the largest perimeter.

[0411] By providing the second flange 703 at the outermost peripheral edge portion of the second cover member 70 having the largest perimeter, the second flange 703 can better contact the heart tissue, and the effect of preventing blood backflow is better.

[0412] In other embodiments, the second flange 703 may be provided between the downstream end of the second cover member 70 and the outermost peripheral edge portion of the second cover member 70 having the largest perimeter, and is not limited herein.

[0413] In all embodiments of the present disclosure, "large" and "small", "many" and "few", "upper" and "lower" are relative terms. For such expressions of relative terms, further explanation is omitted in the embodiments of the present disclosure.

[0414] As described in the specification, "in this embodiment", "in the embodiments of the present disclosure" or "in an alternative embodiment" means that a specific feature, structure or characteristic related to the embodiment is included in at least one embodiment of the present disclosure. Therefore, the "in this embodiment", "in the embodiments of the present disclosure" or "in an alternative embodiment" described in the specification do not necessarily refer to the same embodiment. Also, these specific features, structures or characteristics can be combined in one or two embodiments in any suitable manner. It is obvious to those skilled in the art that all the embodiments described in the specification are alternative embodiments, and the operations and modules involved are not necessarily essential to the present disclosure.

[0415] In various embodiments of the present disclosure, the numbers of the above steps do not limit the execution order, because the execution order of each step is determined by its function and internal logic. Therefore, it should be understood that the numbers of the above steps do not limit the implementation steps of the embodiments of the present disclosure.

[0416] The above are only specific embodiments of the present disclosure, and the protection scope of the present disclosure is not limited thereto. Any changes or substitutions made by those skilled in the art within the technical scope disclosed in the present disclosure belong to the protection scope of the present disclosure. Therefore, the protection scope of the present disclosure shall be subject to the scope of the claims.

[0417] In this specification, relational terms such as first and second are used only to distinguish one entity or action from another entity or action, and do not necessarily require or imply any actual relationship or order between such entities or actions. In addition, terms such as "having", "including" and any variations thereof are intended to cover non-exclusive inclusion. Therefore, a process, method, article or device that includes a series of elements is not necessarily limited to these elements, and may include other elements not specified or inherent to these processes, methods, articles or devices. Unless otherwise specified, for elements limited by the expression "comprising", the situation where the process, method, article or device comprising the elements also has other similar elements is not excluded.

[0418] Industrial Applicability The present disclosure belongs to the technical field of medical devices and provides an (implantable) heart valve stent and an artificial heart valve. According to the technical solution of the present disclosure, it is possible to improve the stability and reliability of the installation and fixation of the heart valve stent, extend the service life of the heart valve stent, reduce the risk of the patient's valve being replaced again, and contribute to the reduction of coronary artery blockage after the heart valve stent is used by the patient.

Description of Reference Numerals

[0419] 1 Artificial heart valve 10 Heart valve stent or (artificial) heart valve stent or implantable heart valve stent 100 Support body 110 Support unit 111 First support structure 112 Second support structure 113 Third support structure 114 First Rivet Joint Structure 115 Second Rivet Joint Structure 116 Third Rivet Joint Structure 120 Flow Passage or Passage 131 Braided Wire 132 Diameter Change Portion 133 Braided Wire 134 Diameter Change Portion 200 Protruding Extension Branch Structure 210 Protruding Extension Portion 220 Protruding Extension Segment 230 Connection Segment 240 Transition Segment 250 Connection Structure 251 Sub-Connection Structure 300 Gap 400 Connection Ring 500 Shape Memory Alloy Tube 600-A First Space 600-B Second Space 20 Valve Tip 30 First Sealing Cover Member 40 Second Sealing Cover Member 800 Support Main Body 810 Support Unit 811 First Support Structure 812 Second Support Structure 813 Third Support Structure 814 First Rivet Joint Structure 815 Second Rivet Joint Structure 816 Third Rivet Joint Structure 900 Protruding Extension Branch Structure 910 Protruding Extension Portion 20 Valve Tip 50 First Cover Member 60 Second Cover Member 601 First Flange 602 Accommodation Notch 70 Second Cover Member 701 First Flange 702 Accommodation Notch 703 Second Flange

Claims

1. A heart valve stent comprising a support body and at least one protruding and extending branched structure connected to the support body, wherein a flow passage through which blood flows is defined in the support body, the protruding and extending branched structure extends from the support body to the outside of the flow passage, a protruding and extending portion capable of abutting against heart tissue is formed in the protruding and extending branched structure, and a gap for accommodating the self-valve leaflet of the heart is formed between the protruding and extending branched structure and the support body. A heart valve stent characterized by the above.

2. 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 respectively, and a second support structure connecting the two first support structures, and a space that can be covered by the connection of a cover member is formed between the two first support structures and the second support structure. The heart valve stent according to claim 1, characterized by the above.

3. A heart valve stent formed by braiding at least one elongated material into a specified shape, wherein a flow passage through which blood flows is defined in the heart valve stent, and at least one of the elongated materials protrudes and extends to the outside of the flow passage to form a protruding and extending portion capable of abutting against heart tissue. A heart valve stent characterized by the above.

4. 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 respectively, and a second support structure connecting the two first support structures, and a space that can be covered by the connection of a cover member is formed between the two first support structures and the second support structure. The heart valve stent according to claim 3, characterized by the above.

5. When the upstream direction and the downstream direction 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. The heart valve stent according to claim 2 or 4, characterized by the above.

6. The two first support structures each extend from both ends of the second support structure in the downstream direction, and the two first support structures merge and are connected. Optionally, the two first support structures each extend from both ends of the second support structure in the downstream direction, and the second ends of the two first support structures are connected to each other. The heart valve stent according to claim 5, characterized in that.

7. Each of the support units is connected to the protruding and extending branch structure, and the protruding and extending branch structure is located between two adjacent support units in the circumferential direction of the support body. The heart valve stent according to any one of claims 2, 5 to 6, characterized in that.

8. Each of the support units is connected to two of the protruding and extending branch structures, and the two protruding and extending branch structures between two adjacent support units are connected to each other. The heart valve stent according to claim 7, characterized in that.

9. The two protruding and extending branch structures between two adjacent support units are formed by one braided wire. The heart valve stent according to claim 8, characterized in that.

10. A connecting ring is formed at a downstream portion of the first support structure. The heart valve stent according to any one of claims 2, 5 to 6, characterized in that.

11. The connecting ring is formed on each of the first support structures. The heart valve stent according to claim 10, characterized in that.

12. A first rivet connection structure is provided at a position upstream of the connecting ring, and the connecting ring is formed as a closed ring by the first rivet connection structure. The heart valve stent according to claim 10, characterized in that.

13. Each support unit and its adjacent support unit are connected by a rivet structure to form a second rivet connection structure. In the second rivet connection structure, the first support structure and the second support structure of two adjacent support units are arranged in parallel, and a gap for accommodating the self-valve tip of the heart is formed between the protruding and extending branch structure and the first support structure and the second support structure in the second rivet connection structure. The heart valve stent according to any one of claims 2, 5 to 6, characterized in that.

14. The two first support structures of each support unit are connected by a rivet structure to form a third rivet connection structure. The heart valve stent according to any one of claims 2, 5 to 6, characterized in that.

15. Along the direction in which blood flows through the flow passage, the protruding and extending branch structure includes continuous protruding and extending segments and connecting segments. The protruding and extending segment bends and extends in a direction away from the flow passage. One end of the connecting segment is connected to the protruding and extending segment, and the other end is connected to the support body. The angle formed between the protruding and extending segment and the axial direction of the flow passage is 1° to 150°. The heart valve stent according to any one of claims 1 to 2, 5 to 6, characterized in that.

16. The horizontal distance (a) between the end of the connecting segment that connects to the protruding and extending segment and the support body located upstream of the flow passage is 1 mm to 20 mm. The heart valve stent according to claim 15, characterized in that.

17. The heart valve stent is formed by braiding at least one elongated material. The heart valve stent according to any one of claims 1 to 2, 5 to 6, characterized in that.

18. Each of the support units further includes a third support structure, and a connecting ring located downstream of the heart valve stent is formed by the third support structure. The heart valve stent according to claim 4 or 6, characterized in that.

19. One end of the third support structure is connected to the first support structure, and the other end forms the protruding and extending portion. The heart valve stent according to claim 18, characterized in that.

20. Each of the support units has two third support structures. One end of each of the two third support structures is connected to the two first support structures respectively, and the other end of each of the two third support structures forms the protruding and extending portion. The heart valve stent according to claim 19, characterized in that.

21. One connecting ring is formed at the most downstream position of each of the third support structures. The heart valve stent according to claim 20, characterized in that.

22. The protruding and extending portion of each support unit and the protruding and extending portion of the adjacent support unit are formed by bending the same elongated material, and the two adjacent protruding and extending portions are continuously formed. The heart valve stent according to any one of claims 4 to 6, 18 to 21, characterized in that.

23. Each of the support units and the adjacent support unit are connected by a rivet structure to form a first rivet joint structure. In the first rivet joint structure, each elongated material is arranged in parallel, and the two protruding extension parts are located in the middle. The heart valve stent according to any one of claims 4 to 6, 18 to 21, characterized in that.

24. The two first support structures of each support unit are connected by a rivet structure to form a second rivet joint structure, and the third support structure is also connected to the second rivet joint structure. The heart valve stent according to any one of claims 18 to 21, characterized in that.

25. The angle formed between the protruding extension direction of the protruding extension part and the direction perpendicular to the axial direction of the flow passage is 15° to 90°. The heart valve stent according to any one of claims 3 to 6, 18 to 21, characterized in that.

26. Along the direction in which blood flows through the flow passage, the third support structure includes a continuous protruding extension segment, a transition segment, and a connection segment. The protruding extension segment forms the protruding extension part. 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. The heart valve stent according to any one of claims 18 to 21, characterized in that.

27. The elongated material includes a shape memory alloy wire. The heart valve stent according to any one of claims 3 to 4, 17 to 26, characterized in that.

28. The second support structure is knitted by a shape memory alloy wire with a diameter change, or A shape memory alloy tube is annularly installed on a part of the outer periphery of the second support structure. The heart valve stent according to any one of claims 2, 5 to 6, 18 to 26, characterized in that.

29. Including a plurality of support units, and a flow passage through which blood flows is defined and formed by the plurality of support units. At least one of the support units includes a protruding extended branched structure, and the protruding extended branched structure forms a protruding extension that protrudes and extends in a direction away from the flow passage and can abut against the heart tissue, and the protruding extended branched structure extends in the upstream direction of the flow passage to form a connection structure that can be connected to the cover member An implantable heart valve stent characterized by the above.

30. Each of the support units includes two first support structures for connecting to different valve tips, and a first space that can be covered by the connection of the cover member is formed between the two first support structures and the connection structure The implantable heart valve stent according to claim 29, characterized by the above.

31. When the upstream direction and the downstream direction are defined along the direction in which blood flows through the flow passage, the connection structure is located upstream of the two first support structures The implantable heart valve stent according to claim 30, characterized by the above.

32. The connection structure includes at least one sub-connection structure, and at least one of the sub-connection structures is installed overlapping or spaced apart from the connection structure The implantable heart valve stent according to claim 30, characterized by the above.

33. The two first support structures each extend in the downstream direction from both ends of the connection structure, and the two first support structures merge and are connected The implantable heart valve stent according to any one of claims 30 to 32, characterized by the above.

34. Each of the support units includes the protruding extended branched structure, and the protruding extended branched structure is located between two adjacent support units in the circumferential direction of the flow passage The implantable heart valve stent according to any one of claims 29 to 32, characterized by the above.

35. Each of the support units includes two of the protruding extended branched structures, and the connection structures formed by the two protruding extended branched structures are connected to each other The implantable heart valve stent according to claim 34, characterized by the above.

36. A second space for passing a medical device is formed between each of the protruding extended branched structures and the first support structure The implantable heart valve stent according to claim 35, characterized by the above.

37. The protruding extended branched structure and the first support structure are formed by braiding with a single braided wire The implantable heart valve stent according to any one of claims 30 to 32, characterized in that...

38. The protruding and extending branch structure is formed with a connecting ring at the end located downstream of the flow passage. The implantable heart valve stent according to any one of claims 29 to 32, characterized in that...

39. Each of the support units and its adjacent support unit are connected by a rivet structure to form a first rivet connection structure. In the first rivet connection structure, the first support structure and the connection structure of two adjacent support units are arranged in parallel. The implantable heart valve stent according to any one of claims 30 to 32, characterized in that...

40. The two first support structures of each support unit are connected by a rivet structure to form a second rivet connection structure. The implantable heart valve stent according to any one of claims 30 to 32, characterized in that...

41. The protruding and extending branch structure includes a first connection segment, a contact segment, and a second connection segment that are sequentially connected. The first connection segment is connected to the first rivet connection structure. The contact segment has a first end connected to the first connection segment and a second end that protrudes and extends in a direction away from the flow passage. The second connection segment has one end connected to the second end of the contact segment and the other end connected to the first support structure. The implantable heart valve stent according to any one of claims 30 to 32, characterized in that...

42. The angle (α) formed between the contact segment and the axial direction of the flow passage is 10° to 150°. The implantable heart valve stent according to claim 41, characterized in that...

43. The distance between the second end of the contact segment and the first connection segment is 1 mm to 20 mm. The implantable heart valve stent according to claim 41, characterized in that...

44. The implantable heart valve stent is formed by braiding with at least one braided wire. The implantable heart valve stent according to any one of claims 29 to 32, characterized in that...

45. The braided wire includes a shape memory alloy wire. The implantable heart valve stent according to claim 42, characterized in that...

46. The connection structure is formed by braiding with a shape memory alloy wire having a diameter change, or A shape memory alloy tube is annularly mounted on a part of the outer periphery of the connection structure The implantable heart valve stent according to any one of claims 30 to 32, characterized in that

47. A heart valve stent according to any one of claims 1 to 28 or an implantable heart valve stent according to any one of claims 29 to 46, and A valve tip provided in the flow passage and connected to the first support structure of the heart valve stent or the implantable heart valve stent, A first sealing cover member installed in and connected to a space formed between two first support structures and the second support structure of the heart valve stent or the implantable heart valve stent to cover the space, Optionally, further comprising a second sealing cover member installed to surround the outer peripheral side of the heart valve stent or the implantable heart valve stent A heart artificial valve, characterized in that

48. The second sealing cover member has a disc shape, and the outer peripheral edge of the second sealing cover member is bent downstream of the heart valve stent to form a protruding edge The heart artificial valve according to claim 47, characterized in that

49. The material of the valve tip is at least one of a polymer material, a biological tissue material, and a tissue engineering material The heart artificial valve according to claim 47 or 48, characterized in that

50. The connection method between the valve tip and the first support structure of the heart valve stent or the implantable heart valve stent is one of sewing with a sewing thread, adhesion, hot melt, and polymer adhesion The heart artificial valve according to claim 47 or 48, characterized in that

51. Including a support main body and at least one protruding and extending branch structure, The support main body includes a plurality of support units, and a plurality of the support units define and form a passage through which blood flows. Each of the support units includes two first support structures for connecting to different valve tips respectively, and at least one of the support units includes a second support structure. The second support structure is provided on the side of the first support structure close to its adjacent support unit, The protruding and extending branch structure is relatively fixed to two adjacent support units and extends from the support main body to the outside of the passage, and a gap for accommodating the self-valve tip of the heart is formed between the protruding and extending branch structure and the support main body A heart valve stent, characterized in that

52. Each of the support units includes two of the second support structures, and the two second support structures in each support unit are respectively provided on both sides of the two first support structures. The heart valve stent according to claim 51, characterized in that.

53. Each of the support units includes a third support structure connected to the two first support structures, and a space covered by the connection of the first cover member is formed between the two first support structures and the third support structure. The heart valve stent according to claim 52, characterized in that.

54. Each of the first support structures is relatively fixed to one of the protruding and extending branch structures, and each of the protruding and extending branch structures is relatively fixedly connected to two adjacent first support structures belonging to two adjacent support units respectively. An intermediate portion of the protruding and extending branch structure forms a protruding and extending portion for abutting against heart tissue. The heart valve stent according to claim 53, characterized in that.

55. Two adjacent second support structures belonging to two adjacent support units respectively are located between the protruding and extending branch structures connecting the two support units along the circumferential direction of the heart valve stent. The heart valve stent according to claim 54, characterized in that.

56. Two adjacent second support structures belonging to two adjacent support units respectively are located inside the protruding and extending branch structures connecting the two support units along the radial direction of the heart valve stent. The heart valve stent according to claim 54, characterized in that.

57. A downstream portion of the two first support structures of the support unit and a downstream portion of the two protruding and extending branch structures are connected by a rivet structure to form a first rivet connection structure, and the two protruding and extending branch structures are two protruding and extending branch structures that are relatively fixed to the two first support structures. The heart valve stent according to any one of claims 54 to 56, characterized in that.

58. Each of the second support structures is relatively fixed to one of the protruding and extending branch structures, and an intermediate portion of the protruding and extending branch structure forms a protruding and extending portion for abutting against heart tissue. The heart valve stent according to claim 53, characterized in that.

59. A part of two adjacent second support structures belonging to two adjacent support units respectively is located between the protruding and extending branch structures connecting the two support units along the circumferential direction of the heart valve stent. The heart valve stent according to claim 58, characterized in that...

60. A part of two adjacent second support structures belonging to each of two adjacent support units is located inside the protruding extension branch structure that connects to these two support units along the radial direction of the heart valve stent. The heart valve stent according to claim 58, characterized in that...

61. The downstream portions of the two first support structures of the support unit are connected by a rivet structure to form a first rivet joint 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 joint structure. The heart valve stent according to any one of claims 58 to 60, characterized in that...

62. 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 joint structure. The heart valve stent according to claim 53, characterized in that...

63. Each support unit is formed by braiding with a single braided wire, and each protruding extension branch structure is formed by another single braided wire. The heart valve stent according to claim 57, 61 or 62, characterized in that...

64. The braided wire includes a diameter change portion, the diameter of the diameter change portion is larger than the diameter of other portions, and the diameter change portion is provided corresponding to the rivet structure. The heart valve stent according to claim 63, characterized in that...

65. The braided wire is made of a shape memory alloy wire with a diameter change shape, thereby forming the diameter change portion, or A shape memory alloy tube is annularly installed on the outer periphery of the braided wire, and the portion where the shape memory alloy tube is annularly installed is the diameter change portion. The heart valve stent according to claim 64, characterized in that...

66. A connection ring is formed downstream of each support unit. The heart valve stent according to any one of claims 53 to 65, characterized in that...

67. The heart valve stent according to any one of claims 51 to 66, and A valve tip provided in the passage and connected to the first support structure of the heart valve stent, and A first cover member configured to cover the space formed between the two first support structures and the third support structure of the support unit of the heart valve stent by connection. A heart valve prosthesis characterized by the above.

68. The heart valve prosthesis further includes a second cover member, the second cover member is installed so as to surround the outer peripheral side of the heart valve stent, the upstream end of the second cover member is connected to the first cover member, and the second cover member has a gradually increasing and then gradually decreasing circumferential length from the upstream end to the downstream end The heart valve prosthesis according to claim 67, characterized by the above.

69. An annular first flange is formed at the downstream end of the second cover member, and the first flange is formed toward the downstream of the heart valve stent The heart valve prosthesis according to claim 68, characterized by the above.

70. A notch for accommodation is formed in the first flange and the second cover member, and the notch for accommodation is configured to accommodate the support body The heart valve prosthesis according to claim 69, characterized by the above.

71. An annular second flange is formed at the outer peripheral edge of the second cover member, and the second flange is formed toward the downstream of the heart valve stent The heart valve prosthesis according to claim 68, characterized by the above.

72. The second flange is provided at the outer peripheral edge portion of the second cover member having the largest circumferential length The heart valve prosthesis according to claim 71, characterized by the above.

Images