CN218338568U

CN218338568U - Artificial heart valve support and heart valve prosthesis

Info

Publication number: CN218338568U
Application number: CN202221803273.6U
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: 2023-01-20
Anticipated expiration: 2032-07-12

Abstract

The application relates to the technical field of medical equipment, and provides a prosthetic heart valve stent and a heart valve prosthesis, wherein the prosthetic heart valve stent comprises a support main body and at least one protruding branch body connected with the support main body; the support body defines a flow channel for the passage of blood therethrough; the convex branch body extends from the support main body to the outer side of the flow channel to form a convex part which can be abutted with heart tissue, and a gap which can contain the native valve leaf of the heart is formed between the convex branch body and the support main body. Through the technical scheme of this application, can improve the fixed stability and the reliability of heart valve support installation to improve heart valve support's life, reduced the risk that the valve was replaced once more to the patient, and help reducing the patient and take place the condition that coronary artery blockked up when using artificial heart valve support.

Description

Artificial heart valve stent and heart valve prosthesis

Technical Field

The application relates to the technical field of medical equipment, in particular to a prosthetic 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 pathological changes, 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, the risk of replacing the valve again by a patient is increased, and the phenomenon of coronary artery blockage easily occurs after part of the heart valve stent is installed.

SUMMERY OF THE UTILITY MODEL

An object of the embodiment of the application is to provide a prosthetic heart valve stent and a heart valve prosthesis, which are used for improving the stability and reliability of mounting and fixing the prosthetic heart valve stent, reducing the risk of replacing a valve again for a patient, and reducing the risk of coronary blockage for the patient.

The embodiment of the application provides a prosthetic heart valve support which comprises a support main body and at least one protruding branch body connected with the support main body; the support body defines a flow channel for the passage of blood; the convex branch body extends from the support main body to the outer side of the flow channel, a convex part capable of being abutted with heart tissue is formed, and a gap capable of accommodating the native valve leaflet of the heart is formed between the convex branch body and the support main body.

In the above embodiment, the prosthetic heart valve stent comprises a support body and at least one projecting limb connected to the support body. The supporting main body is used for being supported at an original aortic valve, a flow channel for blood circulation is defined in the middle of the supporting main body, the convex branch body extends from the supporting main body to the outer side far away from the flow channel and is provided with a convex part for abutting with cardiac tissue (such as an aortic sinus), when the cardiac valve support is supported at the original aortic valve, the convex part abuts with the cardiac tissue to play a role in fixing the cardiac valve support, and the displacement of the cardiac valve support caused by the pressure generated by blood on valve leaflets when the valve leaflets are closed is prevented, so that the supporting stability and reliability of the cardiac valve support at the original aortic valve are improved, and the service life of the cardiac valve support is prolonged; meanwhile, a gap is formed between the protruding branch body and the supporting main body, when the heart valve support is arranged at the original main artery valve, the native valve leaflet of the heart can be contained in the gap, so that the condition that the native valve leaflet of the heart interferes with the heart valve support to cause coronary artery blockage is prevented, and the safety of the artificial heart valve support during installation is improved.

In some embodiments, the support body comprises a plurality of support units, the plurality of support units enclosing to form the flow channel; each support unit comprises two first support bodies and at least one second support body, the two first support bodies are used for being connected with different valve leaflets respectively, the at least one 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 the above embodiments, the heart valve stent comprises a plurality of support units, which are connected to each other and enclose a flow channel for the circulation of blood. Wherein, every support element all includes two first supporter and the second supporter that links to each other with the one end of two first supporters respectively, and is formed with the space that is used for the skirt to connect the cover between second supporter and two first supporters, and when the skirt connection covers in this space for blood can only circulate from the circulation canal, circulates from heart valve support's week side in order to avoid blood.

Illustratively, the number of the supporting units is three, and the three supporting units are arranged in a surrounding manner to form the supporting body.

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 a direction forming a blood inflow end, the two first supports are located in a direction forming a blood outflow end, and blood flows in through the second support and then flows out from the first support.

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

In the above embodiment, the first ends of the two first supporting bodies are respectively connected with the two ends of the second supporting body, and the second ends extend towards the downstream direction of the flow channel and are joined together, so that a closed-loop space for connecting the covering skirts is formed between the two first supporting bodies and the second supporting body. The second ends of the two first supporting bodies can be connected in a riveting or welding mode through riveting tubes.

In some embodiments, the protruding branches are connected to each of the supporting units, and the protruding branches are located between two adjacent supporting units in the circumferential direction of the supporting body.

In the above embodiment, the number of the projecting branches is plural, and the projecting branch is connected to each supporting unit. Specifically, the plurality of convex branches are arranged at intervals and are positioned between two adjacent supporting units in the circumferential direction of the supporting main body, so that when the convex parts of the plurality of convex branches are abutted with heart tissues (such as an aortic sinus), the reliability and the stability of the artificial heart valve stent after installation can be effectively improved.

In some embodiments, two of the protruding branches are connected to each of the supporting units, and two of the protruding branches between two adjacent supporting units are connected to each other.

In the above embodiment, the two protrusions between two adjacent support units are connected at one end in the upstream direction of the flow channel, that is, the two protrusions of the two protrusions are connected to each other, which helps to improve the reliability and stability of the protrusions in contact with the heart tissue.

In some embodiments, two of the protruding branches between two adjacent supporting units are formed by one braided wire.

In the embodiment, two protruding branches between two adjacent supporting units are integrally formed by adopting one weaving wire, and secondary connection in modes of welding, riveting and the like is not needed, so that the production efficiency of products is improved.

In some embodiments, a connection ring is formed in a downstream direction of the first support body.

In the above embodiment, the first support body is formed with a connection ring located downstream of the flow channel for connection with a delivery system of the prosthetic heart valve stent to enable delivery and retrieval of the heart valve stent by the delivery system.

In some embodiments, each of the first supports is formed with the connection ring.

In the above embodiment, the number of the connection rings is multiple, and the connection rings are all located in the downstream direction of the flow channel, which helps to improve the reliability of the prosthetic heart valve stent during the delivery process when the connection rings are all connected with the delivery system of the prosthetic heart valve stent.

In some embodiments, a first riveting node is provided upstream of the connecting ring, the first riveting node forming the connecting ring into a closed loop.

In the above embodiment, by providing the first riveting node at the upstream of the connection ring, the connection ring can form a closed loop structure, which facilitates connection between the connection member of the conveying system and the connection ring, and helps to improve reliability when the connection member of the conveying system is connected to the connection ring.

In some embodiments, each of the support units is connected with an adjacent support unit through a riveting structure to form a second riveting joint, in which the first support body and the second support body of two adjacent support units are arranged in parallel, and the protruding support bodies and the first support body and the second support body in the second riveting joint form the gap for accommodating the native cardiac valve leaflet.

In the above embodiment, each support unit is connected with two adjacent support units through a riveting structure, that is, the connection between the two first support bodies and the second support body of each support unit and the connection between the two first support bodies and the second support body of the adjacent support unit are connected through a riveting structure, and form a second riveting joint. In the first riveting joint, the first supporting body and the second supporting body of two adjacent supporting units are arranged in parallel, so that the connection reliability of each supporting unit is improved, the attractiveness of the product is improved, the protruding supporting bodies and the first supporting body and the second supporting body in the second riveting joint are arranged at intervals, and a gap for accommodating the native valve leaflet of the heart is defined.

In some embodiments, the two first supporting bodies of each supporting unit are connected by a riveting structure and form a third riveting joint.

In the above embodiment, the two first supporting bodies of each supporting unit located at the connecting position downstream of the flow channel are connected through a riveting structure such as a riveting tube to form a third riveting joint, so that the reliability of connection of one end of each supporting unit located at the downstream of the flow channel of the two first supporting bodies is effectively ensured.

In some embodiments, the protrusion branch comprises a continuous protrusion section and a connection section along the direction of blood passing through the flow channel; wherein, the protruding section bends and extends in the direction away from the flow channel; one end of the connecting section is connected with the protruding section, the other end of the connecting section is connected with the supporting main body, and an included angle between the protruding section and the axial direction of the flow channel is in a range of 1-150 degrees.

In the above embodiment, the protruding section is located downstream of the flow channel, and one end of the connecting section is connected to the protruding section, and the other end extends in the downstream direction of the flow channel, and is finally connected to the first support body of the support body. The included angle between the protruding section and the axial direction of the flow channel is set to be in the range of 1-150 degrees, so that the protruding section can correspond to the position of heart tissue (such as aortic sinus) conveniently, the protruding section can abut against the heart tissue conveniently, and the stability of the protruding section abutting against the heart tissue is improved.

Specifically, an installation space is defined between the connecting section and the first support body and is used for allowing medical devices such as coronary stents and the like to pass through when being installed.

In some embodiments, a horizontal distance a between an end of the connection section connected to the protruding section and the support body located upstream of the flow channel is set in a range of 1mm to 20 mm.

In the above embodiment, by setting the distance a between the end of the connecting section connected to the protruding section and the support body located upstream of the flow channel to be in the range of 1mm to 20mm, it is ensured that the protruding section can abut against the heart tissue on the one hand, and the protruding section is prevented from protruding too long to damage other tissues of the heart; on the other hand, the native valve leaflet of the heart can be conveniently accommodated in the gap between the protruding branch body and the supporting main body after abutting against one side of the protruding branch section close to the supporting main body, so that the convenience of accommodating the native valve leaflet of the heart in the gap is improved.

In some embodiments, the heart valve stent is woven from at least one lengthwise material.

In the above embodiments, the elongate material may be, for example, a memory alloy wire or a nitinol wire. When the artificial heart valve support is formed by weaving a lengthwise material, the artificial heart valve support has high integrity and is convenient to machine and form. When the heart valve support is woven by a plurality of lengthwise materials, the two connected lengthwise materials can be fixedly connected by riveting or welding the riveting tubes. In addition, the joint of the two connected longitudinal materials can also be fixedly connected through welding and screw thread connection.

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

In the above embodiment, that is, the artificial heart valve stent is woven by at least one memory alloy wire, the memory alloy wire can deform under the driving of an external force and return to the original shape after the external force is cancelled, so that the artificial heart valve stent can be conveniently conveyed through the conveying system after the memory alloy wire deforms under the driving of the external force, and when the artificial heart valve stent is conveyed to the original aortic valve, the memory alloy wire can quickly return to the original shape, and the reliability of the installation of the heart valve stent at the aortic valve is improved.

In some embodiments, the second support body is woven by using variable diameter memory alloy wires; 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 a prosthetic heart valve stent as described in any one of the embodiments of the first aspect; the valve leaf is arranged in the flow channel and is connected with the first support body of the artificial 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 artificial heart valve stent; and the second sealing skirt cloth is arranged around the outer circumferential side of the artificial heart valve support.

In the above embodiments, the valve leaflet is located in the flow channel and connected to the first support body of 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 allow the blood in the heart to flow to the whole body through the aorta, and when the heart relaxes, the valve leaflet can close in time to prevent the blood in the aorta from flowing back 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. The periphery side of the artificial heart valve stent is also surrounded by a second sealing skirt, and the second sealing group edge is used for preventing blood from flowing back to avoid perivalvular leakage.

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 leaflet is made of bovine pericardium, porcine pericardium, bovine/porcine heart valve, or the like.

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

In the embodiment, the valve leaflet can be fixedly connected with the first support body of the artificial 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 through setting up at least one protruding branch body that links to each other with the support main part, protruding branch body is protruding to stretch the protruding portion that forms in the outside of flowing in the passageway from the support main part, and protruding portion passes through the butt in heart tissue department, and the risk that pure palirrhea patient takes place heart valve support displacement is reduced that can be fine.

2. The utility model provides a but be formed with the space that can hold the native valve leaf of heart between protruding portion and the support subject, the native valve leaf holding of heart in this space to can both reduce the risk that causes coronary artery jam after the installation of heart valve support.

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

4. The heart valve support has longer service life.

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

6. The heart valve prosthesis of the present application is smaller in size and has a lower tendency to cause biological non-fusion.

7. 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 adopting the condition that the too big valve leaflet that leads to of stress damages, drops when suture is made.

Additional features and advantages of the disclosure will be set forth in the description which follows, or in part may be learned by the practice of the above-described techniques of the disclosure, or may be learned by practice 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 structural view of a perspective view of a prosthetic heart valve stent provided in accordance with some embodiments of the present application;

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

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

fig. 4 is a partial structural schematic view of a second supporting 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 prosthetic heart valve stent 100; a support body 10; a support unit 101; a first support 1011; a second support 1012; a flow channel 102; a protruding branch 20; a protruding portion 201; a protruding section 202; a connection section 203; a void 30; a connection ring 40; a first rivet joint 50; a second riveting joint 60; a third riveting node 70; a memory alloy tube 80; a leaflet 200; a first sealing skirt 300; a second sealing skirt 400;

in fig. 1 and 6, the direction of the arrow indicates the direction of blood flow.

Detailed Description

The technical solutions in the embodiments of the present application will be described clearly and completely with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only some embodiments of the present application, and not all embodiments. The components of the embodiments of the present application, generally described and illustrated in the figures herein, can 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 appropriate.

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.

Moreover, the terms "first," "second," and the like, are used primarily to distinguish one device, element, or component from another (the specific type and configuration may or may not be the same), 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, 2 and 6, the present application provides a prosthetic heart valve stent 100 including a support body 10 and at least one protruding branch 20 connected to the support body 10; the support body 10 defines a flow channel 102 for the flow of blood; the protruding branch 20 extends from the support body 10 to the outside of the flow channel 102, and forms a protruding portion 201 capable of contacting with the heart tissue, and a gap 30 capable of accommodating the native valve leaflet of the heart is formed between the protruding branch 20 and the support body 10.

In the above embodiment, the prosthetic heart valve stent 100 includes the support body 10 and at least one projecting leg 20 connected to the support body 10. The supporting main body 10 is used for being supported at an original aortic valve, a flow channel 102 for blood to flow through is defined in the middle of the supporting main body 10, the protruding branch body 20 extends from the supporting main body 10 to the outside far away from the flow channel 102, and a protruding part 201 for abutting against heart tissue (such as an aortic sinus) is formed, when the heart valve stent is supported at the original aortic valve, the protruding part 201 abuts against the heart tissue to play a role of fixing the heart valve stent, and the heart valve stent is prevented from being displaced under the pressure generated by blood on the valve leaflet 200 when the valve leaflet 200 is closed, so that the supporting stability and reliability of the heart valve stent at the original aortic valve are improved, and the service life of the heart valve stent is prolonged; meanwhile, a gap is formed between the protruding branch body 20 and the supporting main body 10, so that when the heart valve stent is installed at the original aortic valve, the native valve leaflets of the heart can be accommodated in the gap, thereby preventing the occurrence of coronary artery blockage caused by mutual interference between the native valve leaflets of the heart and the heart valve stent, and being helpful for improving the safety of the artificial heart valve stent 100 during installation.

Referring to fig. 2, in some embodiments, the supporting body 10 includes a plurality of supporting units 101, and the supporting units 101 surround to form a flow channel 102; each support unit 101 includes two first supports 1011 for connecting to different valve leaflets 200, and at least one second support 1012 connecting to the two first supports 1011, and a space that can be covered by a skirt is formed between the two first supports 1011 and the second support 1012.

In the above embodiment, the heart valve stent comprises a plurality of supporting units 101, and the plurality of supporting units 101 are connected with each other and enclose a flow channel 102 for blood circulation. Each support unit 101 comprises two first support bodies 1011 and a second support body 1012 connected with one end of each of the two first support bodies 1011, and a space for connecting and covering the skirts is formed between the second support body 1012 and the two first support bodies 1011, so that blood can only flow through the flow channel 102 when the skirts are connected and covered in the space, and the blood is prevented from flowing through the periphery of the heart valve stent.

Specifically, in one embodiment, the first support 1011 and the second support 1012 may be formed by knitting the same knitting yarn, and they are continuous, so that they are referred to as the first support 1011 and the second support 1012 for convenience of description. In addition, the supporting unit 101 and the supporting units 101 may be formed by knitting the same knitting yarn.

Illustratively, the number of the supporting units 101 is three, and three supporting units 101 are arranged to form the supporting body 10.

Referring to FIGS. 1 and 2, in some embodiments, the second support 1012 is located upstream of the two first supports 1011, depending on the upstream and downstream directions defined by the direction of blood flow through the flow channel 102.

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 direction of the two first support bodies 1011 forms a blood outflow end, and blood flows in the direction of the second support body 1012 and then flows out of 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 the two first supporting bodies 1011 are joined together.

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 the second ends extend in the downstream direction of the flow channel 102 and are joined together, so that a closed loop space for connecting the covering skirts is formed between the two first supports 1011 and the second support 1012. The second ends of the two first supporting bodies 1011 can be connected by riveting or welding a riveting tube.

Referring to fig. 1 and 2, in some embodiments, a protrusion 20 is connected to each supporting unit 101, and the protrusion 20 is located between two adjacent supporting units 101 in the circumferential direction of the supporting body 10.

In the above embodiment, the number of the protrusions 20 is plural, and the protrusion 20 is connected to each supporting unit 101. Specifically, the plurality of protruding branches 20 are arranged at intervals and located between two adjacent supporting units 101 in the circumferential direction of the supporting body 10, so that after the protruding portions 201 of the plurality of protruding branches 20 are abutted against heart tissue (such as aortic sinus), the reliability and stability of the artificial heart valve stent 100 after installation can be effectively improved.

Specifically, in one embodiment, the protrusion 20 and the supporting unit 101 may be formed by weaving the same woven wire, and the protrusion 20 and the supporting unit 101 are also continuous.

Referring to fig. 1 and 2, in some embodiments, two protrusions 20 are connected to each supporting unit 101, and two protrusions 20 between two adjacent supporting units 101 are connected to each other.

In the above embodiment, the ends of two protrusions 20 between two adjacent supporting units 101 in the upstream direction of flow channel 102 are connected, that is, two protrusions 201 of two protrusions 20 are connected to each other, which helps to improve the reliability and stability of protrusions 201 abutting against heart tissue.

Referring to fig. 1 and 2, in some embodiments, two protruding branches 20 between two adjacent supporting units 101 are formed by a braided wire.

In the above embodiment, two protruding branches 20 between two adjacent supporting units 101 are integrally formed by using one woven wire, and secondary connection by welding or riveting is not required, which is helpful for improving production efficiency of products.

Referring to fig. 1 and 2, in some embodiments, the first support body 1011 has a connection ring 40 formed in a downstream direction.

In the above embodiment, the first support body 1011 is formed with the connection ring 40, and the connection ring 40 is located at the downstream of the flow channel 102 and is used for connecting with the delivery system of the artificial heart valve stent 100, so as to realize the delivery and the recovery of the heart valve stent by the delivery system.

Referring to fig. 1 and 2, in some embodiments, each of the first supporting bodies 1011 is formed with a connection ring 40.

In the above embodiment, in which the number of the connection rings 40 is plural, and the plural connection rings 40 are all located downstream of the flow channel 102, when the plural connection rings 40 are all connected to the delivery system of the prosthetic heart valve stent 100, the reliability of the prosthetic heart valve stent 100 during the delivery process is improved.

Referring to fig. 1 and 2, in some embodiments, a first riveting node 50 is disposed upstream of the connection ring 40, and the first riveting node 50 forms the connection ring 40 into a closed loop.

In the above embodiment, by providing the first riveting joint 50 at the upstream of the connection ring 40, the connection ring 40 can form a closed loop structure, which facilitates the connection of the connection elements of the conveying system with the connection ring 40 and helps to improve the reliability of the connection elements of the conveying system with the connection ring 40.

Referring to fig. 1 and 2, in some embodiments, each supporting unit 101 is connected to an adjacent supporting unit 101 through a riveting structure to form a second riveting node 60, in the second riveting node 60, first supporting bodies 1011 and second supporting bodies 1012 of two adjacent supporting units 101 are arranged in parallel, and a gap 30 for accommodating a native cardiac valve leaflet is formed between the protruding branch body 20 and the first supporting body 1011 and the second supporting body 1012 located in the second riveting node 60.

In the above embodiment, each supporting unit 101 is connected to two adjacent supporting units 101 by 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 by a riveting structure, and form the second riveting joint 60. In the first riveting node 50, the first support 1011 and the second support 1012 of two adjacent support units 101 are arranged in parallel, which helps to improve the reliability of the connection of each support unit 101 and improve the aesthetic appearance of the product, and the protruding support is spaced apart from the first support 1011 and the second support 1012 in the second riveting node 60 and defines a gap for accommodating the native valve leaflet of the heart.

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, and form a third riveting joint 70.

In the above embodiment, the connection positions of the two first supports 1011 of each support unit 101 downstream of the flow channel 102 are connected by a riveting structure such as a riveting tube to form the third riveting joint 70, thereby effectively ensuring the reliability of connection of one ends of the two first supports 1011 of each support unit 101 downstream of the flow channel 102.

Referring to FIGS. 1-3, in some embodiments, in the direction of blood flow through the flow channel 102, the protrusion 20 comprises a continuous protrusion section 202 and a connecting section 203; wherein, the protruding section 202 bends and extends in a direction away from the flow channel 102; one end of the connecting section 203 is connected with the protruding section 202, the other end is connected with the support main body 10, and the included angle between the protruding section 202 and the axial direction of the flow channel 102 is in the range of 1-150 degrees.

In the above embodiment, the protruding section 202 is located downstream of the flow channel 102, and one end of the connection section 203 is connected to the protruding section 202, and the other end extends downstream of the flow channel 102, and is finally connected to the first support 1011 of the support body 10. By setting the included angle between the protruding section 202 and the axial direction of the flow channel 102 within the range of 1 ° to 150 °, the protruding section 202 can be easily positioned corresponding to the heart tissue (e.g., the aortic sinus) to be abutted against the heart tissue, and the stability of the protruding section 202 in abutment against the heart tissue can be improved.

Specifically, an installation space is defined between the connection section 203 and the first support body 1011 for allowing a medical device such as a coronary stent to pass through when being installed.

Referring to fig. 1 to 3, in some embodiments, the horizontal distance a between the end of the connection section 203 connected to the protruding section 202 and the support body 10 located upstream of the flow channel 102 is set in the range of 1mm to 20 mm.

In the above embodiment, by setting the distance a between the end of the connecting section 203 connected to the protruding section 202 and the support main body 10 located upstream of the flow channel 102 within the range of 1mm to 20mm, on one hand, the protruding section 202 can be ensured to be abutted against the heart tissue, and on the other hand, the native heart valve leaflet can be conveniently accommodated in the gap between the protruding support body 10 and the support main body 20 after abutting against the side of the protruding section 202 close to the support main body 10, thereby improving the convenience of accommodating the native heart valve leaflet in the gap.

In some embodiments, the heart valve stent is woven from at least one lengthwise piece of material.

In the above embodiments, the elongated material may be, for example, a memory alloy wire or a nitinol wire. When the artificial heart valve stent 100 is woven by a lengthwise material, the artificial heart valve stent 100 has high integrity and is convenient to machine and form. When the heart valve support is woven by a plurality of lengthwise materials, the two connected lengthwise materials can be fixedly connected by riveting or welding the riveting tubes. In addition, the joint of the two connected longitudinal materials can also be fixedly connected by welding or screwing.

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

In the above embodiment, that is, the artificial heart valve stent 100 is woven by at least one memory alloy wire, the memory alloy wire can be deformed under the driving of an external force, and returns to the original shape after the external force is cancelled, so that the artificial heart valve stent can be conveniently conveyed by the conveying system after the memory alloy wire is deformed under the driving of the external force, and when the artificial heart valve stent is conveyed to the original aortic valve, the memory alloy wire can quickly return to the original shape, thereby improving the reliability of the installation of the heart valve stent at the aortic valve.

Referring to fig. 4, in some embodiments, the second supporting body 1012 is woven by using variable diameter memory alloy wires.

Referring to fig. 5, in some embodiments, a memory alloy tube 80 is partially embedded in the outer periphery of the second supporting body 1012.

In the above embodiment, the second support body 1012 is woven by using variable diameter memory alloy wires, or the memory alloy tube 80 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 support may be improved, and the stability of the support may be further improved.

Referring to fig. 6, in a second aspect, the present application provides a heart valve prosthesis, including a prosthetic heart valve stent 100 according to any one of the embodiments of the first aspect; a leaflet 200 disposed within the flow channel 102 and coupled to the first support 1011 of the prosthetic heart valve stent 100; the first sealing skirt cloth 300 is connected and covered in a space formed between two first supporting bodies 1011 and a second supporting body 1012 of the artificial heart valve stent 100; and a second sealing skirt 400 surrounding the outer circumferential side of the prosthetic heart valve stent 100.

In the above embodiment, the valve leaflet 200 is located in the flow channel 102 and connected to the first support 1011 of the heart valve support, and the opening or closing of the valve leaflet 200 can control whether blood flows, for example, when the heart contracts, the valve leaflet 200 opens to flow the blood in the heart to the whole body through the aorta, and simultaneously, when the heart relaxes, the valve leaflet 200 can close in time to prevent the blood in the aorta from flowing back into the ventricle. The first sealing skirt 300 is arranged 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, so that the circulation of blood from the peripheral side of the heart valve stent can be avoided, and the blood is ensured to flow in only from the blood inflow end and flow out from the blood outflow end. The outer peripheral side of the artificial heart valve stent 100 is also surrounded by a second sealing skirt 400, and the second sealing group edge is used for preventing blood from flowing back and avoiding paravalvular leakage.

Referring to fig. 6, in some embodiments, the second sealing skirt 400 has a disc shape, and the circumferential side of the second sealing skirt 400 is folded back to the downstream of the heart valve stent to form a flange.

In the above embodiment, the second sealing skirt 400 is disc-shaped, so that when the heart valve stent is supported at the original aortic valve, the second sealing skirt 400 abuts against the original heart valve tissue, and the peripheral side of the second sealing skirt 400 is folded towards the downstream direction of the heart valve stent to form a flange, when the valve leaflet 200 is closed, blood can only flow to the upper side of the second sealing skirt 400 from the valve leaflet 200 and flow over the second sealing skirt 400, 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 200 is one of a polymeric material, a biological tissue material, and a tissue engineering material.

In the above embodiments, the material of the leaflet 200 is exemplified by bovine pericardium, porcine pericardium, bovine/porcine heart valve, and the like.

In some embodiments, the connection between the leaflet 200 and the first support 1011 of the prosthetic heart valve stent 100 is one of adhesion, heat fusion, and polymer adhesion.

In the above embodiment, the leaflet 200 can be fixedly connected to the first support 1011 of the artificial heart valve stent 100 by one of adhesion, thermal fusion, and polymer adhesion, so as to prevent the leaflet 200 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," "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 size of the serial number of each process described above does not mean that the execution sequence is necessarily sequential, and the execution sequence of each process should be determined by its function and inherent logic, and should not constitute any limitation on 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 prosthesis stent is characterized by comprising a support main body and at least one convex branch body connected with the support main body; the support body defines a flow channel for the passage of blood; the protruding branch body extends from the support main body to the outer side of the flow channel to form a protruding part which can be abutted with cardiac tissue, and a gap which can contain the native valve leaflet of the heart is formed between the protruding branch body and the support main body.

2. The prosthetic heart valve stent of claim 1, wherein the support body 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, 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.

3. The prosthetic heart valve stent of claim 2, wherein the second support is upstream of the two first supports according to a direction defining an upstream and downstream direction of blood flow through the flow channel.

4. The heart valve prosthesis stent of claim 3, wherein the two first supporting bodies extend from both ends of the second supporting body in the downstream direction, and the two first supporting bodies are joined together.

5. The prosthetic heart valve stent of any one of claims 2-4, wherein the outrigger is connected to each of the support units and is located between two adjacent support units in a circumferential direction of the support body.

6. The prosthetic heart valve stent of claim 5, wherein two of the projecting branches are connected to each of the supporting units, and two of the projecting branches between two adjacent supporting units are connected to each other.

7. The prosthetic heart valve stent of claim 6, wherein two of the projecting branches between two adjacent supporting units are formed of a single piece of braided wire.

8. The prosthetic heart valve stent of any one of claims 2-4, wherein the first support body has a connecting ring formed in a downstream direction.

9. The prosthetic heart valve stent of claim 8, wherein each of the first supports is formed with the attachment ring.

10. The prosthetic heart valve stent of claim 8, wherein the attachment ring is provided with a first rivet joint upstream thereof, the first rivet joint causing the attachment ring to form a closed loop.

11. The stent as claimed in any one of claims 2 to 4, wherein each of the supporting units is connected to an adjacent supporting unit by a riveting structure to form a second riveting joint in which first and second supporting bodies of two adjacent supporting units are arranged in parallel, and the protruding branches form the space for accommodating a native cardiac valve leaflet between the first and second supporting bodies in the second riveting joint.

12. The prosthetic heart valve stent of any one of claims 2-4, wherein the two first supports of each support unit are connected by a riveted structure and form a third riveted joint.

13. The prosthetic heart valve stent of any one of claims 1-4, wherein the protrusion comprises a continuous protrusion section and a connection section in a direction of blood flow through the flow channel;

wherein, the protruding section bends and extends in the direction away from the flow channel; one end of the connecting section is connected with the protruding section, the other end of the connecting section is connected with the supporting main body, and an included angle between the protruding section and the axial direction of the flow channel is in the range of 1-150 degrees.

14. The prosthetic heart valve stent of claim 13, wherein a horizontal distance a between an end of the connecting section connected to the protruding section and the support body upstream of the flow channel is set in a range of 1mm to 20 mm.

15. The prosthetic heart valve stent of any of claims 1-4, wherein the heart valve stent is woven from at least one lengthwise piece of material.

16. The prosthetic heart valve stent of claim 15, wherein the lengthwise material comprises memory alloy wire.

17. The prosthetic heart valve stent of any one of claims 2-4, wherein the second support is woven from a memory alloy wire of variable diameter type; or,

the outer periphery of the second support body is partially embedded with a memory alloy tube.

18. A heart valve prosthesis comprising the prosthetic heart valve stent of any one of claims 1-17;

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

and the second sealing skirt cloth is arranged around the outer circumferential side of the artificial heart valve support.

19. The heart valve prosthesis of claim 18, wherein the second sealing skirt is disk-shaped and a circumferential side of the second sealing skirt is folded over downstream of the heart valve stent to form a cuff.

20. The heart valve prosthesis of claim 18 or 19, wherein the material of the leaflet is one of a polymeric material, a biological tissue material, and a tissue engineering material.

21. The heart valve prosthesis of claim 18 or 19, wherein the leaflet is attached to the first support of the prosthetic heart valve stent by one of sewing, gluing, heat fusing, and polymer attachment.