CN115252224A

CN115252224A - Heart valve support and heart valve prosthesis

Info

Publication number: CN115252224A
Application number: CN202210820049.6A
Authority: CN
Inventors: 梁向斌; 钟伟; 王松
Original assignee: Shanghai Yixin Medical Devices Co ltd
Current assignee: Shanghai Yixin Medical Devices Co ltd
Priority date: 2022-07-12
Filing date: 2022-07-12
Publication date: 2022-11-01

Abstract

The application relates to the technical field of medical equipment, and provides a heart valve stent and a heart valve prosthesis, wherein the heart valve stent is formed by weaving and shaping at least one lengthwise material; the heart valve stent is provided with a flow passage for blood circulation; wherein, at least one lengthwise material protrudes to the outside of the flow channel to form a protrusion part which can be abutted with the heart tissue. Through the technical scheme of this application, when heart valve support props up and connects in former aortic valve department, protruding portion can with looks butt to improve the fixed stability and the reliability of heart valve support installation, thereby improved heart valve support's life, and reduced the risk that the valve was replaced once more to the patient.

Description

Heart valve support and heart valve prosthesis

Technical Field

The application relates to the technical field of medical equipment, in particular to a heart valve stent and a heart valve prosthesis.

Background

The heart valve grows between the atrium and ventricle, between the ventricle and aorta, and acts as a one-way valve to assist the unidirectional movement of blood flow. The four valves of the human body are called the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve, respectively. If these valves become diseased (e.g., become stenotic or incompetent), they can interfere with the movement of blood flow, thereby causing cardiac dysfunction, and ultimately heart failure.

At present, when a valve has a pathological change, the valve replacement is mostly adopted for treatment, namely, an artificial mechanical valve or a biological valve is replaced, but the existing heart valve stent is easy to fall off under the influence of blood flow after being implanted, the stability of installation and fixation is poor, the service life of the artificial heart valve is influenced, and the risk of replacing the valve again by a patient is increased.

Disclosure of Invention

The problem to be solved by the present invention is to provide a heart valve stent which is advantageous for improving the stability after transplantation.

In a first aspect, embodiments of the present application provide a heart valve stent, which is formed by weaving and shaping at least one lengthwise material; the heart valve stent defines a flow channel for the circulation of blood; wherein at least one of the elongated materials protrudes outward of the flow channel to form a protrusion that abuts the cardiac tissue.

The heart valve support provided by the embodiment of the application is used for being supported at an original aortic valve, wherein the heart valve support is formed by weaving and shaping at least one lengthwise material, and a flow channel for blood circulation is defined in the middle of the heart valve support.

In some embodiments, the heart valve stent comprises a plurality of support cells, the plurality of support cells enclosing to form the flow channel; each support unit comprises two first support bodies and a second support body, wherein the two first support bodies are used for being connected with different valve leaflets respectively, the second support body is connected with the two first support bodies, and a space which can be connected and covered by skirt cloth is formed between the two first support bodies and the second support body.

In some embodiments, the heart valve stent includes a plurality of support cells interconnected to one another and enclosing the outflow channel. And each supporting unit comprises two first supporting bodies and a second supporting body which is respectively connected with one end of each first supporting body, a space for connecting and covering the skirting cloth is formed between the second supporting body and the two first supporting bodies, and when the skirting cloth is connected and covered in the space, blood can only flow from the flow channel, so that the blood is prevented from flowing around the heart valve support.

Illustratively, the number of the supporting units is three.

In some embodiments, the second support is located upstream of the two first supports, with the upstream and downstream directions being defined by the direction of blood through the flow channel.

In the above embodiment, the second support is located upstream of the two first supports, that is, the second support is located in the direction of the blood inflow end, the two first supports are located in the direction of the blood outflow end, and the blood flows in through the second support and then flows out through the first supports.

In some embodiments, the two first supporting bodies extend from two ends of the second supporting body to the downstream direction respectively and are connected with the second ends of the two first supporting bodies.

In the above embodiment, the first ends of the two first supporting bodies are connected to the two ends of the second supporting body, respectively, and extend in the downstream direction of the flow passage, and the second ends of the two first supporting bodies are connected to form a closed loop space for connecting the covering skirt cloth to the second supporting body. Wherein, the second ends of the two first supporting bodies can be connected by riveting or welding the riveting tubes.

In some embodiments, each of the support units further comprises a third support forming a connection ring located downstream of the heart valve stent.

In the above embodiment, the support unit further comprises a third support body, the third support body is formed with a connection ring located at the downstream of the heart valve stent, and the connection ring is used for connecting with a delivery system of the heart valve stent and realizing the delivery and recovery of the heart valve stent by the delivery system.

It will be appreciated that each support unit has two third supports, each of which is connected to the second ends of the two first supports at one end of the downstream side of the heart valve stent after the connection ring is formed.

In some embodiments, one end of the third support downstream of the heart valve stent is connected to the first support after forming the connection ring, and the other end upstream of the heart valve stent forms a protrusion for abutment with heart tissue. The third support body can be integrally connected with the first support body or fixedly connected in a riveting or welding mode.

In some embodiments, the number of the third supporting bodies of each supporting unit is two, one end of each of the two third supporting bodies is connected to the two first supporting bodies, and the other end of each of the two third supporting bodies forms the protruding portion.

In the above embodiment, each support unit includes two third supports, two of the third supports are located on two sides of the two first supports, and first ends of the two third supports are respectively connected with one ends of the two first supports located downstream of the flow channel, and the other ends of the two third supports form protrusions for abutting against the heart tissue.

In some embodiments, the connecting ring is formed at the most downstream of each third support.

In the above embodiment, the most downstream of each third support forms a connection ring, and the connection ring is used for connecting with the connection structure of the delivery system, so as to deliver the heart valve stent to the heart tissue through the delivery mechanism, thereby improving the stability and reliability of the delivery process.

In some embodiments, the protrusion of each supporting unit and the protrusion of the adjacent supporting unit are formed by bending the same longitudinal material, and two adjacent protrusions are continuous.

In the above embodiment, two adjacent protruding portions of two adjacent supporting units are formed by bending the same lengthwise material and are continuous, so that damage to cardiac tissue caused by stress concentration of the protruding portions is avoided, the supporting strength of the protruding portions can be improved, and the reliability of installation of the cardiac valve stent is improved.

In some embodiments, each of the supporting units is connected to an adjacent supporting unit by a riveting structure to form a first riveting node, in which the longitudinal materials are arranged in parallel and the two protrusions are located therebetween.

In the above embodiment, each supporting unit is connected to two adjacent supporting units through a riveting structure, that is, the joint of the two first supporting bodies and the second supporting body of each supporting unit and the joint of the two first supporting bodies and the second supporting body of the supporting unit adjacent thereto are connected through a riveting structure, and two first riveting joints are formed, and the third supporting body is also connected to the first riveting joint. In the first riveting joint, the longitudinal materials are arranged in parallel, so that the reliability of the connection of each supporting unit is improved, the attractiveness of the product is improved, and the protruding part of each supporting unit is positioned in the middle of the supporting unit and is convenient to abut against heart tissues.

In some embodiments, the two first supporting bodies of each supporting unit are connected by a riveting structure to form a second riveting joint, and the third supporting body is also connected in the second riveting joint.

In the above embodiment, the two first supporting bodies of each supporting unit and the connecting part located at the downstream of the flow channel are connected by a riveting structure such as a riveting pipe to form a second riveting joint, and the two third supporting bodies of each supporting unit are also connected in the second riveting joint, so that the reliability of connection between the two first supporting bodies and the two third supporting bodies in each supporting unit is effectively ensured.

In some embodiments, an angle between a protruding direction of the protruding portion and a direction perpendicular to the axial direction of the flow channel is in a range of 15 ° to 90 °.

In the above embodiment, by setting the included angle between the plane of the protruding portion and the direction perpendicular to the axial direction of the flow channel to be in the range of 15 ° to 90 °, when the heart valve support is supported and connected to the original aortic valve, the protruding portion can correspond to the heart tissue position, which facilitates the abutment with the heart tissue and helps to improve the stability of the abutment of the protruding portion with the heart tissue.

In some embodiments, the third support comprises consecutive protrusions, transitions and connecting segments along the direction of blood flow through the flow channel; wherein the protruding section forms the protruding portion; one end of the transition section is connected with the convex extending section, the other end of the transition section is bent and extended towards the direction far away from the flow channel, and the included angle between the transition section and the direction vertical to the axial direction of the flow channel is in the range of 60-150 degrees; one end of the connecting section is connected with the transition section, and the other end of the connecting section is connected with the first supporting body.

In the above embodiment, the third support body includes a protruding section, a transition section, and a connection section that are sequentially connected along the flow direction of the flow channel, wherein the protruding section protrudes to the outside of the flow channel to form a protruding portion for abutting against the cardiac tissue, one end of the transition section is connected to the protruding section, the other end of the transition section bends and extends in a direction away from the flow channel, and an included angle between the transition section and the direction perpendicular to the axial direction of the flow channel is set within a range of 60 ° to 150 °, so as to ensure that the heart valve stent can prop open the original aortic valve, thereby ensuring that the blood can normally flow. One end of the connecting section is connected with the transition section, the other end of the connecting section is bent and extended towards the direction close to the first support body, and the connecting section is connected with the first support body after a connecting ring is formed at the most downstream position of the flow channel, so that a larger space can be defined between the third support body and the valve leaflet, and the coronary stent can be installed through the space when a patient performs a coronary stent installation operation.

In some embodiments, the elongated material comprises memory alloy wire.

In the embodiment, the heart valve stent is woven by at least one memory alloy wire, so that the heart valve stent is convenient to deform for conveying through the conveying system, and when the heart valve stent is conveyed to the original aortic valve, the memory alloy wire can quickly restore the original shape, and the reliability of the heart valve stent in supporting the aortic valve is improved. When the heart valve support is woven by adopting a plurality of memory alloy wires, the two connected memory alloy wires are fixedly connected in a riveting or welding mode through the riveting pipe. In addition, the heart valve support can also be fixedly connected through welding and screw connection.

In some embodiments, the second support body is woven by at least one variable diameter memory alloy wire; or a memory alloy pipe is partially embedded on the outer peripheral side of the second supporting body.

In the above embodiment, the second support body is woven by using variable diameter memory alloy wires, or a memory alloy tube may be partially sleeved on the outer circumferential side of the second support body to partially increase the diameter of the second support body, so that the supporting force of the heart valve stent support may be improved, and the stability of the support may be further improved.

In a second aspect, embodiments of the present application provide a heart valve prosthesis, comprising: the heart valve stent of any one of the embodiments of the first aspect; the valve leaflet is arranged in the flow channel and is connected with the first support body of the heart valve support; the first sealing skirt cloth is connected and covered in a space formed between the two first supporting bodies and the second supporting body of the heart valve support; and the second sealing skirt cloth is arranged around the outer peripheral side of the first sealing skirt cloth and is in sealing connection with the first sealing skirt cloth.

In the above embodiments, the valve leaflet is located in the flow channel and connected to the heart valve support, and the opening or closing of the valve leaflet can control whether blood flows, for example, when the heart contracts, the valve leaflet opens to flow the blood in the heart to the whole body through the aorta, and simultaneously, when the heart relaxes, the valve leaflet can close in time to prevent the blood in the aorta from returning to the ventricle. The first sealing skirts are arranged in the space formed between the two first supporting bodies and the second supporting body of each supporting unit of the heart valve stent, so that blood can be prevented from flowing around the heart valve stent, and the blood can only flow in from the blood inflow end and flow out from the blood outflow end. Still enclose at the periphery side of first sealed skirt cloth and be equipped with the sealed skirt cloth of second with first sealed skirt cloth sealing connection, the sealed crowd limit of second is used for preventing blood reflux, avoids taking place the valve peripherad and leaks.

In some embodiments, the second sealing skirt is disk-shaped, and a circumferential side of the second sealing skirt is folded downstream of the heart valve stent to form a flange.

In the above embodiment, the second sealing skirt is discoid, thereby can support when the heart valve support connects in former aortic valve department, the second sealing skirt is organized butt with former heart valve, and the week side of second sealing skirt turns over to the downstream direction of heart valve support and is formed with the turn-ups, then when the leaflet was closed, blood can only flow to the second sealing skirt top from leaflet department, and circulate from the second sealing skirt top, thereby can prevent effectively that blood is palirrhea, avoid taking place the perivalvular leak.

In some embodiments, the material of the leaflet is one of a polymeric material, a biological tissue material, and a tissue engineering material.

In the above embodiments, the material of the valve leaflet is exemplified by bovine pericardium, porcine pericardium, bovine/porcine heart valve, and the like.

In some embodiments, the leaflet is attached to the heart valve stent by one of adhesion, heat fusion, and polymer attachment.

In the embodiment, the valve leaflet can be fixedly connected with the heart valve support in one mode of bonding, hot melting and polymer attachment, so that the valve leaflet is prevented from being damaged and falling off due to stress concentration, and the service life of a product is prolonged.

The technical scheme of the application has the following effects:

1. this application is used for the protruding portion of butt department in the heart tissue through setting up at heart valve support, and the risk that pure regurgitation patient takes place heart valve support displacement of reduction that can be fine.

2. The heart valve support is woven by the memory alloy wires, a connecting ring which can be used for being connected with a conveying system is formed, and the heart valve support can be completely recycled.

3. The heart valve stent has longer service life.

4. The leaflet of this application adopts macromolecular material, helps improving the life of leaflet.

5. The heart valve prosthesis of the present application is smaller in size and has a lower tendency to cause biological incompatibilities.

6. The valve leaflet of this application adopts the even coating of macromolecular material on heart valve support's surface, and adhesive force is bigger, can avoid taking place because of the condition that the too big valve leaflet that leads to of stress damages, drops when adopting the suture to make.

Additional structures and advantages of the disclosure will be set forth in the description which follows, or in part may be learned by practice of the techniques of the disclosure.

In order to make the aforementioned objects, structures and advantages of the present application more comprehensible, preferred embodiments accompanied with figures are described in detail below.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are required to be used in the embodiments of the present application will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered as limiting the scope, and that those skilled in the art can also obtain other related drawings based on the drawings without inventive efforts.

FIG. 1 is a schematic view of a heart valve stent according to some embodiments of the present disclosure;

FIG. 2 is a structural schematic diagram of another perspective of a heart valve stent provided in accordance with some embodiments of the present disclosure;

FIG. 3 is an enlarged view of portion A of FIG. 2;

fig. 4 is a partial structural schematic view of a second support body according to an embodiment of the present application;

fig. 5 is a partial structural schematic view of a second supporting body according to another embodiment of the present application;

fig. 6 is a schematic structural view of a heart valve prosthesis provided in some embodiments of the present application.

Reference numerals are as follows:

a heart valve prosthesis 100; a heart valve stent 10; a leaflet 20; a first sealing skirt 30; a second sealing skirt 40; a support unit 101; the first support 1011; the second support 1012; a third support 1013; a protruding portion 102; a connection ring 103; a flow channel 104; a memory alloy tube 105; a first riveting node 106; a second riveting joint 107; a protruding section 10131; a transition section 10132; a connection section 10133;

in fig. 1 and 4, arrows indicate the direction of blood flow.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. The components of the embodiments of the present application, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following detailed description of the embodiments of the present application, as presented in the figures, is not intended to limit the scope of the claimed application, but is merely representative of selected embodiments of the application. All other embodiments, which can be derived by a person skilled in the art from the embodiments of the present application without making any creative effort, shall fall within the protection scope of the present application.

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

Moreover, some of the above terms may be used to indicate other meanings besides the orientation or positional relationship, for example, the term "on" may also be used to indicate some kind of attachment or connection relationship in some cases. The specific meaning of these terms in this application will be understood by those of ordinary skill in the art as the case may be.

Furthermore, the terms "mounted," "disposed," "provided," "connected," and "connected" are to be construed broadly. For example, it may be a fixed connection, a removable connection, or a unitary construction; can be a mechanical connection, or a point connection; either directly or indirectly through intervening media, or may be an internal communication between two devices, elements or components. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art as the case may be.

Furthermore, the terms "first," "second," and the like, are used primarily to distinguish one device, element, or component from another (the specific nature and configuration may be the same or different), and are not used to indicate or imply the relative importance or number of the indicated devices, elements, or components. "two" means two or more unless otherwise specified.

Referring to fig. 1 to 3, fig. 1 is a schematic structural diagram of a heart valve stent 10 according to some embodiments of the present application; FIG. 2 is a schematic view of another angle of the heart valve stent 10 according to some embodiments of the present disclosure; fig. 3 is an enlarged schematic view of a portion a in fig. 2. In a first aspect, the embodiment of the present application provides a heart valve stent 10, where the heart valve stent 10 is formed by weaving and shaping at least one lengthwise material; the heart valve stent 10 defines a flow channel 104 for the circulation of blood; wherein at least one of the elongated materials protrudes outward of the flow channel 104 to form a protrusion 102 that abuts the heart tissue.

The present invention provides a heart valve stent 10 for being supported at a native aortic valve, wherein the heart valve stent 10 is formed by weaving and shaping at least one lengthwise material, and a flow channel 104 for blood to flow is defined in the middle of the heart valve stent 10, and illustratively, the lengthwise material may be memory alloy wire or nitinol wire, etc., and the at least one lengthwise material partially protrudes to the outside far from the flow channel 104 to form a protrusion 102 for abutting against heart tissue (such as aortic sinus), so that when the heart valve stent 10 is supported at the native aortic valve, the protrusion 102 abuts against the heart tissue to fix the heart valve stent 10, and prevent the heart valve stent 10 from being displaced due to the pressure generated by blood on the leaflets 20 when the leaflets 20 are closed, thereby improving the stability and reliability of the heart valve stent 10 supported at the native aortic valve, extending the service life of the heart valve stent 10, and contributing to improving the stability of the heart valve stent 10 used in patients without calcification.

Referring to fig. 1 and 2, in some embodiments, the heart valve stent 10 includes a plurality of support units 101, the plurality of support units 101 enclosing a flow channel 104; each support unit 101 includes two first supports 1011 for connecting to different valve leaflets 20, and a second support 1012 connecting to the two first supports 1011, and a space is formed between the two first supports 1011 and the second support 1012 and can be covered by a skirt.

In the above embodiment, the heart valve stent 10 includes a plurality of supporting units 101, and the plurality of supporting units 101 are connected to each other and surround the outflow channel 104. Each support unit 101 includes two first supports 1011 and a second support 1012 connected to one end of each of the two first supports 1011, and a space for connecting and covering the skirts is formed between the second support 1012 and the two first supports 1011, so that blood can only flow through the flow channel 104 when the skirts are connected and covered in the space, thereby preventing blood from flowing through the periphery of the heart valve stent 10.

Illustratively, the number of support units is three.

Referring to fig. 1 and 2, in some embodiments, the second support 1012 is located upstream of the two first supports 1011 according to the upstream and downstream directions defined by the direction of blood passing through the flow channel 104.

In the above embodiment, the second support body 1012 is located upstream of the two first support bodies 1011, that is, the direction of the second support body 1012 forms a blood inflow end, the two first support bodies 1011 forms a blood outflow end, and blood firstly flows in through the direction of the second support body 1012 and then flows out from the direction of the first support bodies 1011.

Referring to fig. 1 and fig. 2, in some embodiments, two first supporting bodies 1011 extend from two ends of the second supporting body 1012 in a downstream direction and are connected to second ends of the two first supporting bodies 1011.

In the above embodiment, the first ends of the two first supports 1011 are connected to the two ends of the second support 1012, respectively, and extend in the downstream direction of the flow channel 104, and the second ends of the two first supports 1011 are connected, thereby forming a closed-loop space for connecting the covering skirt with the second support 1012. The second ends of the two first supporting bodies 1011 can be connected by riveting, welding or bonding with a riveting tube. In addition, the two first supporting bodies 1011 and the second supporting body 1012 can also be integrally connected, that is, the same longitudinal material is used to weave and shape different parts.

Referring to fig. 1 and 2, in some embodiments, each support unit 101 further comprises a third support 1013, the third support 1013 forming a connection ring 103 located downstream of the heart valve stent 10.

In the above embodiment, the supporting unit 101 further comprises a third supporting body 1013, the third supporting body 1013 is formed with a connecting ring 103 located at the downstream of the heart valve stent 10, and the connecting ring 103 is used for connecting with a delivery system of the heart valve stent 10, so as to realize the delivery and recovery of the heart valve stent 10 by the delivery system.

It will be understood that each support unit 101 has two third supports 1013, and one end of each of the two third supports 1013 located at the downstream of the heart valve stent 10 is connected to the second ends of the two first supports 1011 after the connecting ring 103 is formed. The connection here includes mechanical connection between the two, such as welding, bonding, riveting, etc.; also included are extensions where both are the same object, i.e. both are the same body, with different names referring to different parts.

Referring to fig. 1 and 2, in some embodiments, one end of the third support 1013 downstream of the heart valve stent 10 is connected to the first support 1011 after forming the connection ring 103, and the other end upstream of the heart valve stent 10 forms the protrusions 102 for abutment with the heart tissue. The third support 1013 may be integrally connected to the first support 1011, or fixedly connected by riveting or welding.

Referring to fig. 1 and 2, in some embodiments, the number of the third supporting bodies 1013 of each supporting unit 101 is two, one end of each of the two third supporting bodies 1013 is connected to the two first supporting bodies 1011, and the other end of each of the two third supporting bodies 1013 forms a protrusion 102.

In the above embodiment, each support unit 101 includes two third supports 1013, the two third supports 1013 are located on both sides of the two first supports 1011, and first ends of the two third supports 1013 are respectively connected with one ends of the two first supports 1011 located downstream of the flow channel 104, and the other ends form protrusions 102 for abutting against the heart tissue.

Referring to fig. 1 and 6, in some embodiments, a connecting ring 103 is formed at the most downstream position of each third support 1013.

In the above embodiment, the most downstream of each third support 1013 forms a connection ring 103, and the connection ring 103 is located at the most downstream side of the flow channel 104 and is used for connecting with the connection structure of the delivery system, so as to deliver the heart valve stent to the heart tissue by the delivery mechanism, thereby improving the stability and reliability of the delivery process.

Referring to fig. 1 and 2, in some embodiments, the protrusion 102 of each supporting unit 101 and the protrusion 102 of the adjacent supporting unit 101 are formed by bending the same longitudinal material, and two adjacent protrusions 102 are continuous.

In the above embodiment, two adjacent protrusions 102 of two adjacent supporting units 101 are formed by bending and continuous the same longitudinal material, so as to prevent the protrusions 102 from damaging the heart tissue due to stress concentration, and further improve the supporting strength of the protrusions 102 and the reliability of installing the heart valve stent.

Referring to fig. 1 and 2, in some embodiments, each supporting unit 101 is connected to an adjacent supporting unit 101 by a riveting structure to form a first riveting node 106, in the first riveting node 106, the longitudinal materials are arranged in parallel, and two protruding portions 102 are located in the middle.

In the above embodiment, each supporting unit 101 is connected to two adjacent supporting units 101 through a riveting structure, that is, the connection between the two first supporting bodies 1011 and the second supporting body 1012 of each supporting unit 101 and the connection between the two first supporting bodies 1011 and the second supporting body 1012 of the supporting unit 101 adjacent thereto are connected through a riveting structure, two first riveting nodes 106 are formed, and the third supporting body 1013 is also connected to the first riveting node 106. In the first riveting node 106, the longitudinal materials are arranged in parallel, which helps to improve the reliability of connection of each supporting unit 101, improve the aesthetic appearance of the product, and facilitate contraction and expansion of the heart valve stent 100, and the protruding part 102 of each supporting unit 101 is located in the middle of the supporting unit 101 to facilitate abutment with heart tissue.

Referring to fig. 1 and 2, in some embodiments, the two first supporting bodies 1011 of each supporting unit 101 are connected by a riveting structure to form a second riveting node 107, and the third supporting body 1013 is also connected to the second riveting node 107.

In the above embodiment, the two first supporting bodies 1011 and the connecting portion located at the downstream of the flow channel 104 of each supporting unit 101 are connected by a riveting structure such as a riveting pipe to form the second riveting joint 107, and the two third supporting bodies 1013 of each supporting unit 101 are also connected in the second riveting joint 107, so that the reliability of connection between the two first supporting bodies 1011 and the two third supporting bodies 1013 in each supporting unit 101 is effectively ensured.

It will be appreciated that riveting as described in any of the above embodiments includes the case where a plurality of elements are held together by a holding member, typically a metal member.

Referring to fig. 3, in some embodiments, the included angle between the plane of the protrusion 102 and the direction perpendicular to the axial direction of the flow channel 104 is in the range of 15 ° to 90 °.

In the above embodiment, by setting the included angle between the plane of the protrusion 102 and the direction perpendicular to the axial direction of the flow channel 104 within the range of 15 ° to 90 °, when the heart valve stent 10 is supported at the native aortic valve, the protrusion 102 can correspond to the position of the heart tissue, thereby facilitating the abutment with the heart tissue and improving the stability of the abutment of the protrusion 102 with the heart tissue.

Referring to FIG. 3, in some embodiments, the third support 1013 includes consecutive protruding sections 10131, transition sections 10132 and connecting sections 10133 along the direction of blood passing through the flow channel 104; wherein the protruding section 10131 forms a protruding part 102; one end of the transition section 10132 is connected with the protruding section, the other end is bent and extended in the direction far away from the flow channel 104, and the included angle between the directions vertical to the axial direction of the flow channel 104 is in the range of 60-150 degrees; the connecting section 10133 has one end connected to the transition section 10132 and the other end connected to the first support 1011.

In the above embodiment, the third support 1013 includes 10131, a transition section 10132 and a connection section 10133 which are connected in sequence along the flow direction of the flow channel 104. The protruding section 10131 protrudes to the outside of the flow channel 104 to form a protruding portion 102 for abutting against heart tissue, one end of the transition section 10132 is connected to the protruding section 10131, the other end of the transition section 10132 bends and extends in a direction away from the flow channel 104, and an included angle between the transition section 10132 and the direction perpendicular to the axial direction of the flow channel 104 is set within a range of 60 degrees to 150 degrees, so as to ensure that the heart valve stent 100 can prop open the original aortic valve, and further ensure that blood can normally flow. The connection section 10133 has one end connected to the transition section 10132 and the other end bent and extended in a direction close to the first support 1011 and connected to the first support 1011 after forming the connection ring 103 at the most downstream of the flow passage 104, thereby defining a large space between the third support 1013 and the leaflet 20 so that the coronary stent can be installed through the space when the patient performs a coronary stent installation procedure.

Illustratively, the protruding section 10131, the transition section 10132 and the connecting section 10133 of the third supporting body 1013 are integrally connected, i.e., formed by knitting and shaping the same longitudinal material.

In some embodiments, the elongated material comprises memory alloy wire.

In the above embodiment, the heart valve stent 10 is woven by at least one memory alloy wire, so that the memory alloy wire is easy to deform for delivery by the delivery system, and when the memory alloy wire is delivered to the original aortic valve, the memory alloy wire can quickly recover the original shape, and the reliability of the heart valve stent 10 in supporting the aortic valve is improved. When the heart valve stent 10 is woven by a plurality of memory alloy wires, two connected memory alloy wires are fixedly connected by riveting or welding the riveting tubes. In addition, the heart valve stent 10 can also be fixedly connected by welding or screwing.

Referring to fig. 4, fig. 4 is a partial structural schematic view of a second supporting body 1012 according to an embodiment of the present disclosure. In some embodiments, second support 1012 is woven from at least one wire of a variable diameter memory alloy.

Referring to fig. 5, fig. 5 is a partial structural schematic view of a second supporting body 1012 according to another embodiment of the present disclosure. In some embodiments, the memory alloy tube 105 is partially embedded in the outer periphery of the second support 1012.

In the above embodiment, the second support body 1012 is woven by using variable diameter memory alloy wires, or the memory alloy tube 105 may be partially sleeved on the outer circumferential side of the second support body 1012 to partially increase the diameter of the second support body 1012, so that the supporting force of the heart valve stent 10 may be increased, and the stability of the support may be further improved.

Referring to fig. 6, fig. 6 is a schematic structural diagram of a heart valve prosthesis 100 according to some embodiments of the present disclosure. In a second aspect of the present application, embodiments provide a heart valve prosthesis 100 comprising: the heart valve stent 10 of any of the embodiments of the first aspect; a leaflet 20 disposed within the flow channel 104 and coupled to a first support 1011 of the heart valve stent 10; the first sealing skirt 30 is connected and covered in a space formed between the two first supporting bodies 1011 and the second supporting body 1012 of the heart valve support 10; and a second sealing skirt cloth 40 which surrounds the outer periphery of the first sealing skirt cloth 30 and is connected with the first sealing skirt cloth 30 in a sealing manner.

In the above embodiment, the valve 20 is located in the flow channel 104 and connected to the heart valve stent 10, and the valve 20 is opened or closed to control the circulation of blood, such as when the heart contracts, the valve 20 is opened to allow the blood in the heart to flow to the whole body through the aorta, and when the heart relaxes, the valve 20 is closed in time to prevent the blood in the aorta from flowing back into the ventricle. The first sealing skirt 30 is disposed in the space formed between the two first support bodies 1011 and the second support body 1012 of each support unit 101 of the heart valve stent 10, so that blood can be prevented from flowing around the heart valve stent 10, and blood can be ensured to flow in only from the blood inflow end and flow out from the blood outflow end. The periphery side of the first sealing skirt cloth 30 is also surrounded by a second sealing skirt cloth 40 which is connected with the first sealing skirt cloth 30 in a sealing way, and the second sealing group edge is used for preventing blood from flowing back to avoid the perivalvular leakage.

Referring to fig. 6, in some embodiments, the second sealing skirt 40 has a disk shape, and the peripheral side of the second sealing skirt 40 is folded to form a flange downstream of the heart valve stent 10.

In the above embodiment, the second sealing skirt 40 is disc-shaped, so that when the heart valve stent 10 is supported at the original aortic valve, the second sealing skirt 40 abuts against the original heart valve tissue, and the peripheral side of the second sealing skirt 40 is folded toward the downstream direction of the heart valve stent 10 to form a flange, when the valve leaflets 20 are closed, blood can only flow over the second sealing skirt 40 from the valve leaflets 20, and flow over the second sealing skirt 40, so that the regurgitation of blood can be effectively prevented, and the perivalvular leakage can be avoided.

In some embodiments, the material of the leaflet 20 is one of a polymeric material, a biological tissue material, and a tissue engineering material.

In the above embodiments, the material of the leaflet 20 is exemplified by bovine pericardium, porcine pericardium, bovine/porcine heart valve, and the like.

In some embodiments, the leaflet 20 is attached to the heart valve stent 10 by one of adhesive bonding, heat staking, or polymer attachment.

In the above embodiment, the leaflet 20 can be fixedly connected to the cardiac valve stent 10 by one of adhesion, heat fusion, and polymer adhesion, so as to prevent the leaflet 20 from being damaged and falling off due to stress concentration, which is helpful to improve the service life of the product.

In all embodiments of the present application, the terms "large" and "small" are relatively speaking, and the terms "upper" and "lower" are relatively speaking, so that descriptions of these relative terms are not repeated herein.

It should be appreciated that reference throughout this specification to "in this embodiment," "in an embodiment of the present application," or "in one of the embodiments" means that a particular structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present application. Thus, the appearances of the phrases "in this embodiment," "in an embodiment of the present application," or "in one of the embodiments" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular structures, or characteristics may be combined in any suitable manner in one or both embodiments. Those skilled in the art should also appreciate that the embodiments described in this specification are all alternative embodiments and that the acts and modules involved are not necessarily required for this application.

In various embodiments of the present application, it should be understood that the sequence numbers of the above-mentioned processes do not imply a necessary order of execution, and the order of execution of each process should be determined by its function and inherent logic, and should not constitute any limitation to the implementation process of the embodiments of the present application.

The above description is only for the specific embodiments of the present application, but the scope of the present application is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present application, and shall be covered by the scope of the present application. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.

Claims

1. A heart valve support is characterized in that,

the heart valve support is formed by weaving and shaping at least one lengthwise material; the heart valve stent defines a flow channel for the passage of blood; wherein at least one of the longitudinal materials protrudes to the outside of the flow channel to form a protrusion part which can be abutted with cardiac tissue.

2. The heart valve stent of claim 1, wherein the heart valve stent comprises a plurality of support cells, the plurality of support cells enclosing to form the flow channel;

each supporting unit comprises two first supporting bodies and a second supporting body, the two first supporting bodies are used for being connected with different valve leaflets respectively, the second supporting bodies are connected with the two first supporting bodies, and a space which can be connected and covered by skirting cloth is formed between the two first supporting bodies and the second supporting bodies.

3. The heart valve stent of claim 2, wherein the second support is located upstream of the two first supports according to the upstream and downstream directions defined by the direction of blood flow through the flow channel.

4. The heart valve stent of claim 3, wherein the two first supports extend in the downstream direction from the two ends of the second support, and the second ends of the two first supports are connected.

5. A heart valve stent according to claim 4, wherein each of the support units further comprises a third support forming a connection ring located downstream of the heart valve stent.

6. A heart valve stent as defined in claim 5, wherein one end of the third support is connected to the first support and the other end forms the protrusion.

7. The heart valve stent of claim 6, wherein the number of the third supports of each of the support units is two, one end of each of the two third supports is connected to the two first supports, and the other end of each of the two third supports forms the protrusion.

8. The heart valve stent of claim 7, wherein the most downstream of each of the third supports forms one of the connection rings.

9. The heart valve stent of any one of claims 2-8, wherein the protrusion of each support unit is formed by bending the same longitudinal material as the protrusion of the adjacent support unit, and the adjacent two protrusions are continuous.

10. The heart valve stent of any one of claims 2-8, wherein each of the supporting units is connected to an adjacent supporting unit by a riveting structure to form a first riveting joint, and the first riveting joint is formed by arranging longitudinal materials in parallel and arranging two protrusions in the middle.

11. The heart valve stent according to any one of claims 5-8, wherein the two first support bodies of each support unit are connected by a riveting structure forming a second riveting node, the third support body also being connected in the second riveting node.

12. The heart valve stent according to any one of claims 1 to 8, wherein an angle between a projecting direction of the projecting portion and a direction perpendicular to the axial direction of the flow channel is in a range of 15 ° to 90 °.

13. The heart valve stent of any one of claims 5-8, wherein the third support comprises consecutive protruding sections, transition sections and connecting sections in the direction of blood flow through the flow channel;

wherein the protruding section forms the protruding portion; one end of the transition section is connected with the protruding section, the other end of the transition section bends and extends in the direction away from the flow channel, and the included angle between the transition section and the direction perpendicular to the axial direction of the flow channel is in the range of 60-150 degrees; one end of the connecting section is connected with the transition section, and the other end of the connecting section is connected with the first supporting body.

14. The heart valve stent of any one of claims 1-8, wherein the lengthwise material comprises memory alloy wire.

15. The heart valve stent of any one of claims 2-8, wherein the second support is woven from a memory alloy wire of variable diameter type; alternatively, the first and second electrodes may be,

and a memory alloy tube is partially embedded on the outer peripheral side of the second supporting body.

16. A heart valve prosthesis comprising the heart valve stent of any one of claims 1-15;

the valve leaf is arranged in the flow channel and is connected with the first support body of the heart valve support;

the first sealing skirt cloth is connected and covered in a space formed between the two first supporting bodies and the second supporting body of the heart valve support;

and the second sealing skirt cloth surrounds the outer peripheral side of the first sealing skirt cloth and is in sealing connection with the first sealing skirt cloth.

17. The heart valve stent of claim 16, wherein the second sealing skirt is disk-shaped, and a peripheral side of the second sealing skirt is folded over downstream of the heart valve stent to form a cuff.

18. The heart valve stent of claim 16 or 17, wherein the material of the leaflet is at least one of a polymeric material, a biological tissue material, and a tissue engineering material.

19. The heart valve stent of claim 16 or 17, wherein the leaflet is attached to the heart valve stent by one of sewing, bonding, heat fusing, and polymer attaching.