Implantable heart valve stent and heart valve prosthesis

Abstract

The present application provides an implantable heart valve stent and a heart valve prosthesis, wherein the implantable heart valve stent includes a plurality of support units, and the plurality of support units are arranged to form a flow channel for blood circulation; wherein at least one support unit includes a convex branch, the convex branch protrudes in a direction away from the flow channel to form a convex portion that can abut against heart tissue, and the convex branch extends in the upstream direction of the flow channel to form a connector that can be connected to a skirt. Through the technical solution of the present application, the stability and reliability of the installation and fixation of the heart valve stent can be improved, and the risk of the patient replacing the valve again can be reduced.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an implantable heart valve stent and a heart valve prosthesis. Background Art

[0002] Heart valves grow between the atria and ventricles, and between the ventricles and aortas, and act as one-way valves to help blood flow in one direction. The four valves in the human body are called the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. If these valves become diseased (such as becoming narrow or incompletely closed), it will affect the movement of blood flow, causing abnormal heart function and eventually leading to heart failure.

[0003] At present, when the valve is diseased, valve replacement is mostly used for treatment, that is, replacing the valve with an artificial mechanical valve or a biological valve. Especially for patients with valve leaflet calcification, the existing heart valve stent is easy to fall off due to blood flow after implantation, and the stability of installation and fixation is poor, which affects the service life of the artificial heart valve and increases the risk of patients having to replace the valve again. Summary of the invention

[0004] The purpose of the embodiments of the present application is to provide an implantable heart valve stent, which is used to improve the stability and reliability of the installation and fixation of the heart valve stent and reduce the risk of the patient having to replace the valve again.

[0005] In a first aspect, an embodiment of the present application provides an implantable heart valve stent, which includes a plurality of support units, and the plurality of support units are arranged to form a flow channel for blood circulation; wherein at least one of the support units includes a protruding branch, the protruding branch protrudes in a direction away from the flow channel to form a protruding portion that can abut against heart tissue, and the protruding branch extends in the upstream direction of the flow channel to form a connector that can be connected to a skirt.

[0006] In the above embodiment, the heart valve stent includes a plurality of support units, which are interconnected and enclose a flow channel for blood circulation. Among them, at least one support unit includes a convex branch body, and the convex branch body convexly extends in a direction away from the flow channel to form a convex portion, and the convex portion is used to abut against the heart tissue. When the heart valve stent is supported at the original aortic valve, the convex portion abuts against the heart tissue, thereby playing a role in fixing the heart valve stent, preventing the heart valve stent from being displaced due to the pressure generated by the blood on the valve leaflets when the valve leaflets are closed, thereby improving the stability and reliability of the heart valve stent supported at the original aortic valve, and improving the service life of the heart valve stent. At the same time, the convex branch body extends upstream of the flow channel to form a connector for connecting the sealing skirt. After the sealing skirt is connected to the connector, it can prevent blood from flowing from the peripheral side of the flow channel, and improve the smoothness of blood flowing along the axial direction of the flow channel.

[0007] Specifically, for patients with severe leaflet calcification, the protruding portion can directly abut against the patient's calcified leaflets. Since the calcified leaflets are harder, the protruding portion can play a good supporting role when abutting against them, and ensure the reliability and stability of the heart valve when it is supported at the original heart valve.

[0008] In some embodiments, each of the support units includes two first support bodies respectively connected to different leaflets, and a first space that can be connected and covered by a skirt is formed between the two first support bodies and the connecting body.

[0009] In the above embodiment, each support unit includes two first support bodies, and a first space for skirt connection and covering is formed between the two first support bodies and the connecting body. When the skirt connection covers in the space, blood can only flow through the flow channel to avoid blood flowing from the peripheral side of the heart valve stent.

[0010] In some embodiments, the upstream and downstream directions are defined according to the direction of blood passing through the flow channel, and the connector is located in the upstream direction of the two first supports and is continuous with one end of the protruding branch located in the upstream direction of the flow channel to form the connector.

[0011] In the above embodiment, the connector is located in the upstream direction of the two first supports, that is, the direction of the connector forms a blood inflow end, and the direction of the two first supports forms a blood outflow end, and the blood first flows in from the direction of the connector and then flows out from the direction of the first supports. The connector is configured as a connector, and the connector is continuous with one end of the protruding branch located in the upstream direction of the flow channel, thereby forming a connector for the skirt to connect and cover.

[0012] In some embodiments, the connector includes at least one sub-connector, and at least one of the sub-connectors is overlapped or spaced apart from the connector.

[0013] In the above embodiments, by connecting at least one sub-connector to the connector and stacking or spacing at least two support bodies, the support strength of the connector when supporting the original heart valve can be improved, thereby further improving the stability of the heart valve stent during installation.

[0014] In some embodiments, the two first supports extend from two ends of the connector toward the downstream direction respectively, and the two first supports are joined and connected.

[0015] In the above embodiment, the first ends of the two first support bodies are respectively connected to the two ends of the connector, and the second ends extend toward the downstream direction of the flow channel and merge and connect, thereby forming a closed loop space for connecting the covering skirt with the connector.

[0016] Exemplarily, the second ends of the two first support bodies, and the connection between the two first support bodies and the connecting body can be connected by riveting or welding.

[0017] In some embodiments, each of the support units includes the convex extension, and the convex extension is located between two adjacent support units along the circumferential direction of the flow channel.

[0018] In the above embodiment, there are multiple protruding branches, and each support unit includes a protruding branch. Specifically, the multiple protruding branches are arranged at intervals and are located between two adjacent support units in the circumferential direction of the support body. When the protruding parts of the multiple protruding branches abut against the heart tissue (such as calcified leaflets), the reliability and stability of the heart valve stent after installation can be effectively improved.

[0019] In some embodiments, each of the support units includes two protruding branches, and a connecting body formed by the two protruding branches is connected to each other.

[0020] In the above embodiment, the connecting body formed by the two protruding branches of each support unit is connected to each other (such as being integrally connected, welded or riveted, etc.), which helps to improve the stability of the sealing skirt when it is connected and covered in the space formed between the connecting body and the first support body, and helps to improve the integrity of the product, and improve the reliability and stability of the heart valve stent when it is supported at the original heart valve.

[0021] In some embodiments, a second space for a medical device to pass through is formed between each of the protruding branches and the first support body.

[0022] In the above embodiment, a second space for medical devices such as coronary stents to pass through is formed between each protruding branch and the first support body connected thereto, thereby facilitating the installation of medical devices such as coronary stents after the heart valve stent is installed.

[0023] In some embodiments, the protruding branch and the first support body are formed by braiding a braided wire.

[0024] In the above embodiment, the protruding support body and the first support body are woven from a braided wire, and the two are continuous, without the need for secondary connection such as welding or riveting, which helps to improve the production efficiency of the product and helps to improve the integrity of the product.

[0025] In some embodiments, a connecting ring is formed at one end of the protruding branch located downstream of the flow channel.

[0026] In the above embodiment, a connecting ring is provided on the protruding branch, and the connecting ring is located downstream of the flow channel, and is used to connect with the delivery system of the artificial heart valve stent to realize the delivery and recovery of the heart valve stent through the delivery system.

[0027] In some embodiments, each of the support units is connected to an adjacent support unit through a riveting structure to form a first riveted knot, in which the first support bodies and connecting bodies of two adjacent support units are arranged in parallel, and the end of the protruding branch located upstream of the flow channel is located in the first riveted knot.

[0028] In the above embodiment, each support unit is connected to two adjacent support units through a riveting structure, that is, the connection between the two first support bodies and the connecting body of each support unit, and the connection between the two first support bodies and the connecting body of the adjacent support unit are connected together through a riveting structure to form a first riveted knot. In the first riveted knot, the first support bodies and the connecting body of the two adjacent support units are arranged in parallel, which helps to improve the reliability of the connection of each support unit and improve the aesthetics of the product, and the end of the protruding branch located upstream of the flow channel is also located in the second riveted knot and is continuous with the connecting body.

[0029] In some embodiments, the two first supporting bodies of each supporting unit are connected by a riveting structure to form a second riveted joint.

[0030] In the above embodiment, the connection between the two first support bodies of each support unit located downstream of the flow channel is connected by a riveted structure such as a riveted tube to form a second riveted knot, thereby effectively ensuring the reliability of the connection at one end of the two first support bodies in each support unit located downstream of the flow channel.

[0031] In some embodiments, the protruding branch includes a first connecting section, an abutting section, and a second connecting section connected in sequence, the first connecting section is connected to the first rivet joint; the first end of the abutting section is connected to the first connecting section, and the second end protrudes away from the flow channel; one end of the second connecting section is connected to the second end of the abutting section, and the other end is connected to the first support body.

[0032] In the above embodiment, the protruding branch includes a first connecting segment, an abutting segment and a second connecting segment which are connected in sequence, wherein at least a portion of the first connecting segment is located in the first rivet joint and is continuous with the connecting body; the first end of the abutting segment is connected to the first connecting segment, and the second end protrudes toward the outside of the flow channel, thereby forming a protruding portion that can abut against the heart tissue; one end of the second connecting segment is connected to the abutting segment, and the other end extends in a direction close to the flow channel, and finally connected to the first support body.

[0033] In some embodiments, the angle α between the abutment section and the axial direction of the flow channel is in the range of 10° to 150°.

[0034] In the above embodiment, by setting the angle α between the abutment section and the axial direction of the flow channel within the range of 10° to 150°, it is possible to facilitate the abutment of the abutment section with the position of the heart tissue (such as calcified leaflets), and to help improve the stability of the abutment section when abutting with the heart tissue.

[0035] In some embodiments, a distance b between the second end of the abutting segment and the first connecting segment is in the range of 1 mm to 20 mm.

[0036] In the above embodiment, the first connecting section is connected to the first riveted joint along the axial direction of the flow channel. By setting the distance b between the second end of the abutting section and the first connecting section within the range of 1 mm to 20 mm, on the one hand, it can ensure that the abutting section can abut against the heart tissue, and on the other hand, it can prevent the abutting section from protruding too far to the outside of the flow channel, thereby damaging the heart tissue.

[0037] In some embodiments, the implantable heart valve stent is formed by braiding at least one braided wire.

[0038] In the above embodiments, the braided wire can be memory alloy wire or nickel-titanium alloy wire, etc., for example. Among them, when the heart valve stent is formed by braiding a single braided wire, the heart valve stent has a high integrity and is easy to process and form. When the heart valve stent is formed by braiding multiple longitudinal materials, the two connected longitudinal materials can be fixedly connected by riveting or welding. In addition, the connection between the two connected longitudinal materials can also be fixedly connected by welding or threaded connection.

[0039] In some embodiments, the braided wires include memory alloy wires.

[0040] In the above embodiment, the heart valve stent is made of at least one memory alloy wire, which can be deformed under the influence of external force and return to its original shape after the external force is removed. This facilitates the artificial heart valve stent to be transported through the transport system after the memory alloy wire is deformed under the influence of external force, and when transported to the original aortic valve, the memory alloy wire can quickly return to its original shape, thereby improving the reliability of the heart valve stent installation at the aortic valve.

[0041] In some embodiments, the connector is woven from variable diameter memory alloy wires; or, a memory alloy tube is partially embedded in the outer circumference of the connector.

[0042] In the above embodiments, the connector is woven from variable diameter memory alloy wires, or a memory alloy tube may be partially sleeved on the outer circumference of the connector to partially increase the diameter of the connector, thereby increasing the supporting force of the heart valve stent and further improving the stability of the support.

[0043] In the second aspect, an embodiment of the present application provides a heart valve prosthesis, comprising an implantable heart valve stent as described in any one of the embodiments of the first aspect; a valve leaflet disposed in the flow channel and connected to the first support body of the implantable heart valve stent; a first sealing skirt connected and covered in the space formed between the two first support bodies and the connecting body of the heart valve stent; and a second sealing skirt surrounded by the outer peripheral side of the implantable heart valve stent.

[0044] In the above embodiment, the valve leaflets are located in the flow channel and connected to the first support body of the heart valve stent. The opening or closing of the valve leaflets can control whether the blood circulates. For example, when the heart contracts, the valve leaflets open to allow the blood in the heart to flow to the whole body through the aorta. At the same time, when the heart relaxes, the valve leaflets can be closed in time to prevent the blood in the aorta from flowing back into the ventricle. A first sealing skirt is provided in the space formed between the two first support bodies and the connector of each support unit of the heart valve stent, so as to prevent blood from flowing from the peripheral side of the heart valve stent and ensure that blood only flows in from the blood inlet end and flows out from the blood outlet end. A second sealing skirt is also provided around the peripheral side of the implantable heart valve stent, and the second sealing skirt is used to prevent blood from flowing back and avoid paravalvular leakage.

[0045] In some embodiments, the second sealing skirt is disc-shaped, and a peripheral side of the second sealing skirt is folded toward the downstream of the heart valve stent to form a flange.

[0046] In the above embodiment, the second sealing skirt is disc-shaped, so that when the heart valve stent is supported on the original aortic valve, the second sealing skirt is in contact with the original heart valve tissue, and the circumferential side of the second sealing skirt is folded toward the downstream direction of the heart valve stent to form a flange. When the valve leaflet is closed, blood can only flow from the valve leaflet to the top of the second sealing skirt and flow from the top of the second sealing skirt, thereby effectively preventing blood reflux and avoiding paravalvular leakage.

[0047] In some embodiments, the material of the leaflet is one of a polymer material, a biological tissue material and a tissue engineering material.

[0048] In the above embodiments, illustratively, the material of the leaflet is bovine pericardium, porcine pericardium, bovine / porcine heart valve, or the like.

[0049] In some embodiments, the leaflet is connected to the first support body of the heart valve stent by bonding, hot melting, or polymer adhesion.

[0050] In the above embodiments, the leaflets can be fixedly connected to the first support body of the heart valve stent by one of the methods of bonding, hot melting, and polymer adhesion, so as to prevent the leaflets from being damaged or falling off due to stress concentration, thereby helping to increase the service life of the product.

[0051] The technical solution of this application has the following effects:

[0052] 1. The implantable heart valve stent provided in the present application includes a plurality of support units, at least one of which is provided with a convex branch, and the convex branch protrudes outward from the flow channel to form a convex portion, and the convex portion abuts against the heart tissue. Especially for patients with calcification, the entire structure can effectively reduce the risk of heart valve stent displacement in patients with pure reflux.

[0053] 2. The heart valve stent of the present application is made of memory alloy wire and is formed with a connecting ring that can be used to connect to a delivery system, thereby enabling full recovery of the heart valve stent.

[0054] 3. The heart valve stent of the present application has a longer service life.

[0055] 4. The valve leaflets of the present application are made of polymer materials, which helps to increase the service life of the valve leaflets.

[0056] 5. The heart valve prosthesis of the present application is smaller in size and less prone to bio-incompatibility.

[0057] 6. The valve leaflets of the present application are coated evenly on the surface of the heart valve stent using polymer materials, which have greater adhesion and can avoid damage or falling off of the valve leaflets due to excessive stress when sewing with sutures.

[0058] Other features and advantages of the present disclosure will be set forth in the following description, or some features and advantages may be inferred or unambiguously determined from the description, or may be learned by implementing the above-mentioned technology of the present disclosure.

[0059] In order to make the above-mentioned objects, features and advantages of the present application more obvious and easy to understand, preferred embodiments are specifically cited below and described in detail with reference to the attached drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments of the present application will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0061] Figure 1 A schematic structural diagram of an implantable heart valve stent provided in an embodiment of the present application from one perspective;

[0062] Figure 2 A schematic structural diagram of an implantable heart valve stent provided in an embodiment of the present application from another perspective;

[0063] Figure 3 for Figure 2 The enlarged structural diagram of the middle A part;

[0064] Figure 4 A schematic diagram of a connection structure of a connector provided in an embodiment of the present application;

[0065] Figure 5 A schematic diagram of another connection structure of a connector provided in an embodiment of the present application;

[0066] Figure 6 A schematic diagram of the structure of a heart valve prosthesis provided in an embodiment of the present application.

[0067] Reference numerals:

[0068] Implantable heart valve stent 100; leaflet 200; first sealing skirt 300; second sealing skirt 400; support unit 10; protruding branch 20; connecting ring 30; first riveted knot 40; second riveted knot 50; first space 60; second space 70; first support body 101; flow channel 103; protruding portion 201; connecting body 202;

[0069] in, Figure 1 and Figure 6 The direction of the arrows in the figure indicates the direction of blood circulation. DETAILED DESCRIPTION

[0070] The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all of the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the application claimed for protection, but merely represents the selected embodiments of the present application. Based on the embodiments of the present application, all other embodiments obtained by those skilled in the art without making creative work belong to the scope of protection of the present application.

[0071] In the present application, the terms "upper", "lower", "left", "right", "front", "back", "top", "bottom", "inner", "outer", "middle", "vertical", "horizontal", "lateral", "longitudinal" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings. These terms are mainly used to better describe the present application and its embodiments, and are not used to limit the indicated devices, elements or components to have a specific orientation, or to be constructed and operated in a specific orientation.

[0072] In addition, some of the above terms may be used to express other meanings in addition to indicating orientation or positional relationship. For example, the term "on" may also be used to express a certain dependency or connection relationship in some cases. For those of ordinary skill in the art, the specific meanings of these terms in this application can be understood according to specific circumstances.

[0073] In addition, the terms "installed", "set", "provided with", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral structure; it can be a mechanical connection, or a point connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be an internal connection between two devices, elements, or components. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0074] In addition, the terms "first", "second", etc. are mainly used to distinguish different devices, elements or components (the specific types and structures may be the same or different), and are not used to indicate or imply the relative importance and quantity of the indicated devices, elements or components. Unless otherwise specified, "plurality" means two or more.

[0075] Please refer to Figure 1 , Figure 2 and Figure 6The first aspect of the present application provides an implantable heart valve stent 100, comprising a plurality of support units 10, wherein the plurality of support units 10 are arranged to form a flow channel 103 for blood circulation; wherein at least one support unit 10 comprises a protruding branch 20, the protruding branch 20 protrudes in a direction away from the flow channel 103 to form a protruding portion 201 that can abut against heart tissue, and the protruding branch 20 extends in the upstream direction of the flow channel 103 to form a connector 202 that can be connected to a skirt.

[0076] In the above embodiment, the implantable heart valve stent 100 includes a plurality of support units 10, which are interconnected and enclose a flow channel 103 for blood circulation. Among them, at least one support unit 10 includes a convex branch 20, and the convex branch 20 convexly extends in a direction away from the flow channel 103 to form a convex portion 201, and the convex portion 201 is used to abut against the heart tissue. When the heart valve stent is supported at the original aortic valve, the convex portion 201 abuts against the heart tissue, thereby playing a role in fixing the heart valve stent, preventing the heart valve stent from being displaced due to the pressure generated by the blood on the leaflets 200 when the leaflets 200 are closed, thereby improving the stability and reliability of the heart valve stent at the original aortic valve, and improving the service life of the heart valve stent. At the same time, the protruding portion 201 extends upstream of the flow channel 103 to form a connector 202 for connecting to the sealing skirt. After the sealing skirt is connected to the connector 202, blood can be prevented from flowing from the peripheral side of the flow channel 103, thereby improving the smoothness of blood flowing along the axial direction of the flow channel 103.

[0077] Specifically, for patients whose leaflets 200 are severely calcified, the protruding portion 201 can directly abut against the patient's calcified leaflets. Since the calcified leaflets 200 are harder, the protruding portion 201 can play a good supporting role when abutting against them, and ensure the reliability and stability of the heart valve when it is supported at the original heart valve.

[0078] Specifically, in one embodiment, the convex limb 20 and the support unit 10 can be formed by the same braided wire, and the two are continuous. The reason why they are called convex limb 20 and support unit 10 is for the convenience of description. In addition, each support unit 10 and multiple support units 10 can also be formed by the same braided wire.

[0079] Please refer to Figure 1 and Figure 2 In some embodiments, each support unit 10 includes two first support bodies 101 respectively connected to different leaflets 200, and at least one connector 202 connecting the two first support bodies 101, and a first space 60 that can be connected and covered by a skirt is formed between the two first support bodies 101 and the connector 202.

[0080] In the above embodiment, each support unit 10 includes two first support bodies 101, and a first space 60 for skirt connection covering is formed between the two first support bodies 101 and the connecting body 202. When the skirt connection covers in the space, blood can only flow from the flow channel 103 to avoid blood flowing from the peripheral side of the heart valve stent.

[0081] Please refer to Figure 1 and Figure 2 In some embodiments, the upstream and downstream directions are defined according to the direction of blood passing through the flow channel 103, and the connector 202 is located in the upstream direction of the two first support bodies 101, and is continuous with one end of the protruding branch 20 located in the upstream direction of the flow channel 103 to form the connector 202.

[0082] In the above embodiment, the connector 202 is located in the upstream direction of the two first supports 101, that is, the direction of the connector 202 forms a blood inflow end, and the direction of the two first supports 101 forms a blood outflow end, and the blood first flows in from the direction of the connector 202, and then flows out from the direction of the first supports 101. The connector 202 is configured as a connector 202, and the connector 202 is continuous with one end of the protruding branch 20 located in the upstream direction of the flow channel 103, thereby forming a connector 202 for the skirt to connect and cover.

[0083] Please refer to Figure 4 and Figure 5 In some embodiments, the connector 202 includes at least one sub-connector 2021 , and the at least one sub-connector 2021 is overlapped or spaced apart from the connector 202 .

[0084] In the above embodiment, by connecting at least one sub-connector 2021 to the connector 202, at least one sub-connector 2021 is superimposed or spaced apart with the connector 202, the supporting strength of the connector 202 when supported on the original heart valve can be improved, so as to further improve the stability of the heart valve stent during installation.

[0085] Please refer to Figure 1 and Figure 2 In some embodiments, the two first support bodies 101 extend from two ends of the connector 202 toward the downstream direction respectively, and the two first support bodies 101 are joined and connected.

[0086] In the above embodiment, the first ends of the two first support bodies 101 are respectively connected to the two ends of the connector 202, and the second ends extend toward the downstream direction of the flow channel 103 and merge and connect, thereby forming a closed loop space for connecting the covering skirt with the connector 202.

[0087] Exemplarily, the second ends of the two first support bodies 101 and the connection between the two first support bodies 101 and the connecting body 202 can be connected by riveting or welding.

[0088] Please refer to Figure 1 and Figure 2 In some embodiments, each support unit 10 includes a convex extension 20 , and the convex extension 20 is located between two adjacent support units 10 along the circumference of the flow channel 103 .

[0089] In the above embodiment, there are multiple protruding branches 20, and each support unit 10 includes a protruding branch 20. Specifically, the multiple protruding branches 20 are arranged at intervals and are located between two adjacent support units 10 in the circumferential direction of the support body. When the protruding portions 201 of the multiple protruding branches 20 abut against the heart tissue (such as calcified leaflets), the reliability and stability of the heart valve stent after installation can be effectively improved.

[0090] Please refer to Figure 1 and Figure 2 In some embodiments, each support unit 10 includes a connecting body 202 formed by two protruding branches 20 connected to each other.

[0091] In the above embodiment, the connecting body 202 formed by the two protruding branches 20 of each support unit 10 is connected to each other (such as being integrally connected, welded or riveted, etc.), which helps to improve the stability of the sealing skirt when it is connected and covered in the space formed between the connecting body 202 and the first support body 101, and helps to improve the integrity of the product, and improve the reliability and stability of the heart valve stent when it is supported at the original heart valve.

[0092] Please refer to Figure 1 and Figure 2 In some embodiments, a second space 70 for the medical device to pass through is formed between each protruding branch 20 and the first support body 101.

[0093] In the above embodiment, a second space 70 for medical devices such as coronary stents to pass through is formed between each protruding branch 20 and the first support body 101 connected thereto, thereby facilitating the installation of medical devices such as coronary stents after the heart valve stent is installed.

[0094] In some embodiments, the protruding branch 20 and the first support body 101 are formed by braiding a braided wire.

[0095] In the above embodiment, the protruding support 20 and the first support body 101 are woven from a braided wire, and the two are continuous, without the need for secondary connection such as welding or riveting, which helps to improve the production efficiency of the product and helps to improve the integrity of the product.

[0096] Please refer to Figure 1 , Figure 2 and Figure 6 In some embodiments, a connecting ring 30 is formed at one end of the protruding branch 20 located downstream of the flow channel 103 .

[0097] In the above embodiment, a connecting ring 30 is provided on the protruding branch 20. The connecting ring 30 is located downstream of the flow channel 103 and is used to connect with the delivery system of the artificial heart valve stent to realize the delivery and recovery of the heart valve stent through the delivery system.

[0098] Please refer to Figure 1 and Figure 2 In some embodiments, each support unit 10 is connected to an adjacent support unit 10 through a riveting structure to form a first riveted junction 40. In the first riveted junction 40, the first support bodies 101 and connecting bodies 202 of two adjacent support units 10 are arranged in parallel, and one end of the protruding branch 20 located upstream of the flow channel 103 is located in the first riveted junction 40.

[0099] In the above embodiment, each support unit 10 is connected to two adjacent support units 10 through a riveting structure, that is, the connection between the two first support bodies 101 of each support unit 10 and the connecting body 202, and the connection between the two first support bodies 101 of the adjacent support unit 10 and the connecting body 202 are connected together through a riveting structure to form a first riveted joint 40. In the first riveted joint 40, the first support bodies 101 and the connecting body 202 of the two adjacent support units 10 are arranged in parallel, which helps to improve the reliability of the connection of each support unit 10 and improve the aesthetics of the product, and the end of the protruding branch 20 located upstream of the flow channel 103 is also located in the second riveted joint 50 and is continuous with the connecting body 202.

[0100] Please refer to Figure 1 and Figure 2 In some embodiments, the two first support bodies 101 of each support unit 10 are connected by a riveting structure to form a second riveted joint 50 .

[0101] In the above embodiment, the connection between the two first support bodies 101 of each support unit 10 located downstream of the flow channel 103 is connected by a riveted structure such as a riveted tube to form a second riveted joint 50, thereby effectively ensuring the reliability of the connection at one end of the two first support bodies 101 in each support unit 10 located downstream of the flow channel 103.

[0102] Please refer to Figure 1 , Figure 2 and Figure 3In some embodiments, the protruding branch 20 includes a first connecting section, abutting section, and a second connecting section connected in sequence, the first connecting section is connected to the first rivet joint 40; the first end of the abutting section is connected to the first connecting section, and the second end protrudes in a direction away from the flow channel 103; one end of the second connecting section is connected to the second end of the abutting section, and the other end is connected to the first support body 101.

[0103] In the above embodiment, the protruding branch 20 includes a first connecting section, an abutting section and a second connecting section which are connected in sequence, wherein at least a portion of the first connecting section is located in the first rivet knot 40 and is continuous with the connecting body 202; the first end of the abutting section is connected to the first connecting section, and the second end protrudes toward the outside of the flow channel 103, thereby forming a protruding portion 201 that can abut against the heart tissue; one end of the second connecting section is connected to the abutting section, and the other end extends in a direction close to the flow channel 103, and finally connected to the first support body 101.

[0104] Please refer to Figure 3 In some embodiments, the angle α between the abutting section and the axial direction of the flow channel is in the range of 10° to 150°.

[0105] In the above embodiment, by setting the angle α between the abutment section and the axial direction of the flow channel within the range of 10° to 150°, it is possible to facilitate the abutment of the abutment section with the position of the heart tissue (such as calcified leaflets), and to help improve the stability of the abutment section when abutting with the heart tissue.

[0106] Please refer to Figure 3 In some embodiments, a distance b between the second end of the abutting section and the first connecting section is in the range of 1 mm to 20 mm.

[0107] In the above embodiment, the first connecting section is connected to the first rivet knot 40 along the axial direction of the flow channel. By setting the distance b between the second end of the abutting section and the first connecting section within the range of 1 mm to 20 mm, on the one hand, it can ensure that the abutting section can abut against the heart tissue, and on the other hand, it can prevent the abutting section from protruding too far to the outside of the flow channel 103, thereby damaging the heart tissue.

[0108] In some embodiments, the implantable heart valve stent 100 is formed by braiding at least one braided wire.

[0109] In the above embodiments, the braided wire can be memory alloy wire or nickel-titanium alloy wire, etc., for example. Among them, when the heart valve stent is formed by braiding a single braided wire, the heart valve stent has a high integrity and is easy to process and form. When the heart valve stent is formed by braiding multiple longitudinal materials, the two connected longitudinal materials can be fixedly connected by riveting or welding. In addition, the connection between the two connected longitudinal materials can also be fixedly connected by welding or threaded connection.

[0110] In some embodiments, the braided wires include memory alloy wires.

[0111] In the above embodiment, the heart valve stent is made of at least one memory alloy wire, which can be deformed under the influence of external force and return to its original shape after the external force is removed. This facilitates the artificial heart valve stent to be transported through the transport system after the memory alloy wire is deformed under the influence of external force, and when transported to the original aortic valve, the memory alloy wire can quickly return to its original shape, thereby improving the reliability of the heart valve stent installation at the aortic valve.

[0112] In some embodiments, the connector 202 is woven from variable diameter memory alloy wires; or, a memory alloy tube is partially embedded in the outer circumference of the connector 202 .

[0113] In the above embodiment, the connector 202 is woven with variable diameter memory alloy wire, or a memory alloy tube can be partially sleeved on the outer peripheral side of the connector 202 to partially increase the diameter of the connector 202, thereby improving the supporting force of the heart valve stent and further improving the stability of the support.

[0114] Please refer to Figure 6 The second aspect of the present application provides a heart valve prosthesis, including an implantable heart valve stent 100 as in any one of the first aspect embodiments; a valve leaflet 200, which is arranged in the flow channel 103 and connected to the first support body 101 of the implantable heart valve stent 100; a first sealing skirt 300, which is connected and covered in the space formed between the two first support bodies 101 and the connecting body 202 of the heart valve stent; and a second sealing skirt 400, which is surrounded by the outer peripheral side of the implantable heart valve stent 100.

[0115] In the above embodiment, the leaflets 200 are located in the flow channel 103 and connected to the first support body 101 of the heart valve stent. The opening or closing of the leaflets 200 can control whether the blood circulates. For example, when the heart contracts, the leaflets 200 open to allow the blood in the heart to flow to the whole body through the aorta. At the same time, when the heart relaxes, the leaflets 200 can be closed in time to prevent the blood in the aorta from returning to flow into the ventricle. A first sealing skirt 300 is provided in the space formed between the two first support bodies 101 and the connector 202 of each support unit 10 of the heart valve stent, so as to prevent blood from circulating around the heart valve stent and ensure that blood only flows in from the blood inlet end and flows out from the blood outlet end. A second sealing skirt 400 is also provided around the outer peripheral side of the heart valve stent 100. The second sealing skirt 400 is used to prevent blood from reflux and avoid paravalvular leakage.

[0116] In some embodiments, the second sealing skirt 400 is disc-shaped, and the circumferential side of the second sealing skirt 400 is folded toward the downstream of the heart valve stent to form a cuff.

[0117] In the above embodiment, the second sealing skirt 400 is disc-shaped, so that when the heart valve stent is supported on the original aortic valve, the second sealing skirt 400 can be in contact with the original heart valve tissue, and the circumferential side of the second sealing skirt 400 is folded toward the downstream direction of the heart valve stent to form a flange. When the leaflet 200 is closed, blood can only flow from the leaflet 200 to the top of the second sealing skirt 400, and flow from the top of the second sealing skirt 400, thereby effectively preventing blood reflux and avoiding paravalvular leakage.

[0118] In some embodiments, the material of the leaflet 200 is one of a polymer material, a biological tissue material, and a tissue engineering material.

[0119] In the above embodiment, illustratively, the material of the leaflet 200 is bovine pericardium, porcine pericardium, bovine / porcine heart valve or the like.

[0120] In some embodiments, the leaflet 200 and the first support body 101 of the heart valve stent are connected by bonding, hot melting, or polymer adhesion.

[0121] In the above embodiment, the leaflet 200 can be fixedly connected to the first support body 101 of the heart valve stent 100 by one of the methods of bonding, hot melting, and polymer adhesion, so as to prevent the leaflet 200 from being damaged or falling off due to stress concentration, which helps to improve the service life of the product.

[0122] In all the embodiments of the present application, "big" and "small" are relative, "more" and "less" are relative, and "up" and "down" are relative. The expressions of such relative terms are not elaborated in the embodiments of the present application.

[0123] It should be understood that the "in this embodiment", "in the embodiment of the present application" or "in one of the embodiments" mentioned throughout the specification means that the specific features, structures or characteristics related to the embodiment are included in at least one embodiment of the present application. Therefore, "in this embodiment", "in the embodiment of the present application" or "in one of the embodiments" appearing throughout the specification may not necessarily refer to the same embodiment. In addition, these specific features, structures or characteristics can be combined in one or more embodiments in any suitable manner. Those skilled in the art should also be aware that the embodiments described in the specification are all optional embodiments, and the actions and modules involved are not necessarily required for the present application.

[0124] In the various embodiments of the present application, it should be understood that the size of the serial numbers of the above-mentioned processes does not necessarily mean the order of execution. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present application.

[0125] The above is only a specific implementation of the present application, but the protection scope of the present application is not limited thereto. Any person skilled in the art who is familiar with the present technical field can easily think of changes or substitutions within the technical scope disclosed in the present application, which should be included in the protection scope of the present application. Therefore, the protection scope of the present application should be based on the protection scope of the claims.

Claims

1. A heart valve prosthesis, characterized in that: Including implantable heart valve stents; The implantable heart valve stent comprises a plurality of support units, and the plurality of support units are arranged to form a flow channel for blood circulation; Wherein, at least one of the support units comprises a convex branch body, the convex branch body protrudes in a direction away from the flow channel to form a convex portion that can abut against the heart tissue, and the convex branch body extends in an upstream direction of the flow channel to form a connector that can be connected to the skirt; Each of the support units is connected to an adjacent support unit through a riveting structure to form a first riveted joint, in which the two first support bodies and the two connecting bodies of two adjacent support units are arranged in parallel; The heart valve prosthesis further comprises: A valve leaflet is disposed in the flow channel and connected to the first support body of the implantable heart valve stent; A first sealing skirt connected to and covering the space formed between the two first supporting bodies and the connecting body of the heart valve stent; A second sealing skirt is arranged around the outer peripheral side of the heart valve stent; The second sealing skirt is in a disc shape, and a peripheral side of the second sealing skirt is folded toward the downstream of the heart valve stent to form a flange.

2. The heart valve prosthesis according to claim 1, characterized in that: Each of the support units comprises two first support bodies respectively connected to different leaflets, and a first space which can be connected and covered by a skirt is formed between the two first support bodies and the connecting body.

3. The heart valve prosthesis according to claim 2, characterized in that: The upstream and downstream directions are defined according to the direction in which blood passes through the flow channel, and the connector is located in the upstream direction of the two first supports.

4. The heart valve prosthesis according to claim 2, characterized in that: The connector includes at least one sub-connector, and at least one of the sub-connectors is arranged to overlap or be spaced apart from the connector.

5. The heart valve prosthesis according to any one of claims 2 to 4, characterized in that: The two first supporting bodies extend from two ends of the connecting body toward the downstream direction respectively, and the two first supporting bodies are joined and connected.

6. The heart valve prosthesis according to any one of claims 1 to 4, characterized in that: Each of the support units includes the convex extension, and the convex extension is located between two adjacent support units along the circumferential direction of the flow channel.

7. The heart valve prosthesis according to claim 6, characterized in that: Each of the support units includes two protruding branches, and a connecting body formed by the two protruding branches is connected to each other.

8. The heart valve prosthesis according to claim 7, characterized in that: A second space for passing a medical device is formed between each of the protruding branches and the first support body.

9. The heart valve prosthesis according to any one of claims 2 to 4, characterized in that: The protruding branch and the first support body are formed by weaving a braided wire.

10. The heart valve prosthesis according to any one of claims 1 to 4, characterized in that: A connecting ring is formed at one end of the protruding branch located downstream of the flow channel.

11. The heart valve prosthesis according to any one of claims 2 to 4, characterized in that: The two first supporting bodies of each supporting unit are connected by a riveting structure to form a second riveted joint.

12. The heart valve prosthesis according to any one of claims 2 to 4, characterized in that: The protruding branch includes a first connecting section, a butt section and a second connecting section connected in sequence, the first connecting section is connected to the first rivet joint; the first end of the butt section is connected to the first connecting section, and the second end protrudes in a direction away from the flow channel; one end of the second connecting section is connected to the second end of the butt section, and the other end is connected to the first support body.

13. The heart valve prosthesis according to claim 12, characterized in that: An included angle α between the abutting section and the axial direction of the flow channel is in the range of 10° to 150°.

14. The heart valve prosthesis according to claim 12, characterized in that: A distance b between the second end of the abutting section and the first connecting section is in the range of 1 mm to 20 mm.

15. The heart valve prosthesis according to claim 9, characterized in that: The braided wires include memory alloy wires.

16. The heart valve prosthesis according to any one of claims 2 to 4, characterized in that: The connector is woven from variable diameter memory alloy wires; or a memory alloy tube is partially embedded in the outer peripheral side of the connector.

17. The heart valve prosthesis according to claim 1, characterized in that: The material of the leaflet is at least one of a polymer material, a biological tissue material and a tissue engineering material.

18. The heart valve prosthesis according to claim 1, characterized in that: The connection method between the valve leaflet and the first support body of the implantable heart valve stent is one of suture sewing, bonding, hot melting, and polymer adhesion.

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