CN115177409A

CN115177409A - Implanted heart valve stent and heart valve prosthesis

Info

Publication number: CN115177409A
Application number: CN202210820044.3A
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: 2022-10-14

Abstract

The application provides an implanted heart valve stent and a heart valve prosthesis, wherein the implanted heart valve stent comprises a plurality of supporting units, and a flow channel for blood circulation is formed by the surrounding of the supporting units; wherein, at least one supporting unit comprises a convex branch body, the convex branch body convexly extends in the direction far away from the flow passage to form a convex part which can be abutted with the heart tissue, and the convex branch body extends in the upstream direction of the flow passage to form a connecting body which can be connected with the skirting cloth. Through the technical scheme of this application, can improve fixed stability and the reliability of heart valve support installation to reduce the risk that the patient replaces the valve once more.

Description

Implanted heart valve stent and heart valve prosthesis

Technical Field

The application relates to the technical field of medical equipment, in particular to an implantable 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 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 is diseased, a valve replacement operation is mostly adopted for treatment, namely, an artificial mechanical valve or a biological valve is replaced, particularly for a patient with valve leaflet calcification, an 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 valve replacement of the patient is increased.

Disclosure of Invention

It is an object of embodiments of the present application to provide an implantable heart valve stent for improving the stability and reliability of the mounting and fixation of the heart valve stent and reducing the risk of a patient replacing the valve again.

In a first aspect, embodiments of the present application provide an implantable heart valve stent, which includes a plurality of support units, where the plurality of support units enclose a flow channel for blood to flow through; at least one of the supporting units comprises a protruding branch body, the protruding branch body protrudes and extends towards the direction far away from the flow channel to form a protruding part which can be abutted against the cardiac tissue, and the protruding branch body extends towards the upstream direction of the flow channel to form a connecting body which can be connected with the skirt cloth.

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. The at least one supporting unit comprises a convex branch body, the convex branch body convexly extends in the direction far away from the flow channel to form a convex part, the convex part is used for abutting against heart tissues, when the heart valve support is supported at the original aortic valve, the convex part abuts against the heart tissues, so that the effect of fixing the heart valve support is achieved, the heart valve support is prevented from being displaced under the pressure effect of blood on valve leaflets when the valve leaflets are closed, the supporting stability and reliability of the heart valve support at the original aortic valve are improved, and the service life of the heart valve support is prolonged. Meanwhile, the convex branch body extends towards the upstream of the flow passage to form a connecting body for connecting the sealing skirts, and after the sealing skirts are connected with the connecting body, blood can be prevented from flowing from the peripheral side of the flow passage, and the smoothness of the blood in axial flowing along the flow passage is improved.

Specifically, for the patient with the valve leaflet having serious calcification, the protruding part can be directly abutted with the calcified valve leaflet of the patient, and the calcified valve leaflet has high hardness, so that the protruding part can play a good supporting role when being abutted with the calcified valve leaflet, and the reliability and the stability of the heart valve at the original heart valve support are ensured.

In some embodiments, each of the support units includes two first supports respectively connected to different valve leaflets, and a first space coverable by a skirt connection is formed between the two first supports and the connecting body.

In the above embodiment, each support unit includes two first support bodies, and a first space for the skirt cloth to connect and cover is formed between the two first support bodies and the connecting body, and when the skirt cloth is connected and covered in the space, blood can only flow through the flow passage, so as to avoid the blood flowing through the peripheral side of the heart valve stent.

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

In the above embodiment, the connecting body is located in the upstream direction of the two first supporting bodies, that is, the direction of the connecting body forms the blood inflow end, the direction of the two first supporting bodies forms the blood outflow end, and blood flows in from the direction of the connecting body and then flows out from the direction of the first supporting bodies. And the connector is configured as a connector which is continuous with one end of the protruding branch body in the upstream direction of the flow channel, thereby forming a connector for connecting and covering the skirt cloth.

In some embodiments, the connecting body comprises at least one sub-connecting body, and at least one sub-connecting body is arranged on the connecting body in a superposition mode or a spaced mode.

In the above embodiment, the connecting body is connected to at least one sub-connecting body, and the at least two supporting bodies are arranged in an overlapping manner or at intervals, so that the supporting strength of the connecting body when the connecting body supports the original heart valve can be improved, and the stability of the heart valve stent during installation can be further improved.

In some embodiments, the two first supporting bodies extend from two ends of the connecting body to the downstream direction respectively, 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 connecting 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 connecting body.

For example, the second ends of the two first supporting bodies and the connection mode of the two first supporting bodies and the connecting body can be connected by riveting or welding a riveting tube.

In some embodiments, each of the support units includes the protrusion, and the protrusion is located between two adjacent support units in the circumferential direction of the flow channel.

In the above embodiment, the number of the protrusions is plural, and each of the support units includes the protrusion. Specifically, the plurality of protruding 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 protruding parts of the plurality of protruding branches abut against heart tissues (such as calcified valve leaflets), the reliability and the stability of the heart valve stent after installation can be effectively improved.

In some embodiments, each of the support units includes two of the protruding branches, and the connectors formed by the two protruding branches are connected to each other.

In the above embodiment, the connecting body formed by the two protruding branches of each supporting unit is connected with each other (e.g., integrally connected, welded or riveted), so as to contribute to improving the stability of the sealing skirt when the sealing skirt is connected and covered in the space formed between the connecting body and the first supporting body, and contribute to improving the integrity of the product, and improve the reliability and stability of the heart valve stent supported and connected to the original heart valve.

In some embodiments, a second space is formed between each of the protruding branches and the first support for passing a medical device.

In the above embodiment, a second space for passing medical devices such as coronary stents is formed between each protruding branch body and the first supporting body connected with the protruding branch body, so as to facilitate convenience in installation of the medical devices such as coronary stents after the installation of the heart valve stents.

In some embodiments, the protruding branch and the first support are woven by a weaving wire.

In the embodiment, the protruding branch body and the first supporting body are woven by one weaving yarn, and the protruding branch body and the first supporting body are continuous and do not need to be connected secondarily in modes of welding, riveting or the like, so that the production efficiency of a product is improved, and the integrity of the product is improved.

In some embodiments, the end of the protrusion downstream of the flow channel is formed with a connection ring.

In the above embodiment, the protruding branch body is provided with a connection ring, and the connection ring is located at the downstream of the flow channel and is used for connecting with a delivery system of the artificial heart valve stent, so that the delivery and the recovery of the heart valve stent can be realized through the delivery system.

In some embodiments, each of the support units is connected to an adjacent support unit through a riveting structure to form a first riveting joint, in the first riveting joint, the first support bodies and the connecting bodies of two adjacent support units are arranged in parallel, and one end of the protruding support body, which is located at the upstream of the flow channel, is located in the first riveting joint.

In the above embodiment, each supporting unit is connected with two adjacent supporting units through a riveting structure, that is, the connection point of the two first supporting bodies and the connecting body of each supporting unit and the connection point of the two first supporting bodies and the connecting body of the supporting unit adjacent thereto are connected together through a riveting structure, and form a first riveting joint. In the first riveting joint, the first supporting bodies and the connecting bodies of two adjacent supporting units 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 end, located at the upstream of the flow channel, of the convex branch body is also located in the second riveting joint and is continuous with the connecting bodies.

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

In the above embodiment, the two first supporting bodies of each supporting unit located at the connection position downstream of the flow channel are connected through a riveting structure such as a riveting tube to form a second 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 protruding branch comprises a first connecting section, an abutting section and a second connecting section which are connected in sequence, wherein the first connecting section is connected in the first riveting joint; the first end of the abutting section is connected with the first connecting section, and the second end of the abutting section protrudes in the direction far away from the flow channel; one end of the second connecting section is connected with the second end of the abutting section, and the other end of the second connecting section is connected with the first supporting body.

In the above embodiment, the protruding branch includes a first connection section, an abutting section and a second connection section connected in sequence, wherein at least a portion of the first connection section is located in the first riveting joint and is continuous with the connection body; the first end of the abutting section is connected with the first connecting section, and the second end of the abutting section protrudes towards the outer side of the flow channel so as to form a protruding part capable of abutting with the heart tissue; one end of the second connecting section is connected with the abutting section, and the other end of the second connecting section extends towards the direction close to the flow channel and is finally connected with the first supporting body.

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

In the above embodiment, by setting the angle α between the abutment section and the axial direction of the flow channel to be in the range of 10 ° to 150 °, it is possible to facilitate the abutment of the abutment section with the position of the heart tissue (e.g., calcified leaflets), and to contribute to the improvement of the stability of the abutment section in abutment with the heart tissue.

In some embodiments, the distance b between the second end of the abutment section and the first connection section is in the range of 1mm to 20 mm.

In the above embodiment, the first connecting section is connected to the first riveting node along the axial direction of the flow channel, and the distance b between the second end of the abutting section and the first connecting section is set within the range of 1mm to 20mm, so that on one hand, the abutting section can be ensured to abut against cardiac tissue, and on the other hand, the abutting section can be prevented from protruding to the outside of the flow channel for too long a distance, which causes damage to the cardiac tissue.

In some embodiments, the implantable heart valve stent is formed from at least one braided wire.

In the above embodiments, the braided wire may be, for example, a memory alloy wire or a nitinol wire, etc. When the heart valve support is formed by weaving one piece of weaving silk, the heart valve support is high in integrity and 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 braided wires comprise memory alloy wires.

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

In some embodiments, the connector is woven from variable diameter memory alloy wires; or a memory alloy pipe is partially embedded on the outer peripheral side of the connecting body.

In the above embodiment, the connector 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 connector to partially increase the diameter of the connector, 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 provide a heart valve prosthesis comprising an implantable 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 implanted heart valve support; the first sealing skirt cloth is connected and covered in a space formed between the two first supporting bodies and the connecting body of the heart valve support; and the second sealing skirt cloth is arranged around the outer circumferential side of the implanted heart valve support.

In the above embodiment, the valve leaflets are 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 leaflets can control whether blood flows, for example, when the heart contracts, the valve leaflets open to allow the blood in the heart to flow to the whole body through the aorta, and when the heart relaxes, the valve leaflets close in time to prevent the blood in the aorta from flowing back into the ventricle. The first sealing skirts are arranged in the space formed between the two first supporting bodies and the connecting 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 peripheral side of the implanted heart valve stent is also surrounded by a second sealing skirt cloth which is used for preventing blood from flowing back and avoiding perivalvular leakage.

In some embodiments, the second sealing skirt is disc-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-mentioned embodiment, the sealed skirt of second is discoid to can support when former aortic valve department at heart valve support, the sealed skirt of second is organized the looks butt with former heart valve, and the week side of the sealed skirt of second turns over to the downstream direction of heart valve support and is formed with the turn-ups, when then the leaflet is closed, blood can only flow to the sealed skirt of second top from leaflet department, and circulate from the sealed skirt of second top, thereby can prevent effectively that blood from 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 first support of 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 first support body of 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. the application provides an implantation type heart valve support includes a plurality of supporting element, and at least one supporting element is through setting up protruding branch body, and protruding branch body is protruding to stretch into protruding portion of stretching in the outside of circulation channel, and protruding portion passes through the butt in heart tissue department, especially to calcification patient, and the risk that pure regurgitation patient emergence heart valve support displacement that whole structure can be fine reduces.

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 support has longer service life.

4. The utility model provides a leaflet adopts macromolecular material, helps improving leaflet's life.

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

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 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.

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

Drawings

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 view angle of an implantable heart valve stent provided in an embodiment of the present application;

FIG. 2 is a schematic structural view from another perspective of an implantable heart valve stent provided in accordance with an embodiment of the present application;

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

FIG. 4 is a schematic view of a connection structure of a connector according to an embodiment of the present disclosure;

FIG. 5 is a schematic view of another connection structure of the connector provided in the embodiments of the present application;

fig. 6 is a schematic structural diagram of a heart valve prosthesis provided in an embodiment of the present application.

Reference numerals are as follows:

an implantable heart valve stent 100; a leaflet 200; a first sealing skirt 300; a second sealing skirt 400; a support unit 10; a protruding branch 20; a connection ring 30; a first rivet joint 40; a second riveting node 50; the first space 60; a second space 70; a first support 101; a flow channel 103; a protruding portion 201; a connecting body 202;

note that the direction of the arrow in fig. 1 and 6 indicates the direction in which blood flows.

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 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 appropriate.

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. "plurality" means two or more unless otherwise specified.

Referring to fig. 1, fig. 2 and fig. 6, in an embodiment of the first aspect of the present application, an implantable cardiac valve stent 100 is provided, which includes a plurality of support units 10, wherein the plurality of support units 10 enclose a flow channel 103 for blood circulation; wherein, at least one support unit 10 comprises a protrusion branch 20, the protrusion branch 20 protrudes to the direction far away from the flow channel 103 to form a protrusion 201 capable of abutting with the heart tissue, and the protrusion branch 20 extends to the upstream direction of the flow channel 103 to form a connecting body 202 capable of connecting with the skirt.

In the above embodiment, the implantable heart valve stent 100 includes a plurality of support units 10, and the plurality of support units 10 are connected to each other and enclose the flow channel 103 for blood to flow through. Wherein, at least one supporting unit 10 includes a protruding branch 20, and the protruding branch 20 protrudes towards the direction far away from the flow channel 103 to form a protruding portion 201, the protruding portion 201 is used for abutting against the heart tissue, when the heart valve support is supported at the original aortic valve, the protruding portion 201 abuts against the heart tissue, thereby playing the role of fixing the heart valve support, preventing the heart valve support from displacing under the pressure effect generated by blood on the valve leaflet 200 when the valve leaflet 200 is closed, thereby improving the stability and reliability of the support of the heart valve support at the original aortic valve, and improving the service life of the heart valve support. Meanwhile, the convex part 201 extends to the upstream of the flow channel 103 to form a connecting body 202 for connecting the sealing skirt, and after the sealing skirt is connected with the connecting body 202, the blood can be prevented from flowing from the peripheral side of the flow channel 103, so that the fluency of the blood flowing along the axial direction of the flow channel 103 is improved.

Specifically, for a patient with the valve leaflet 200 being calcified seriously, the protruding part 201 can be directly abutted with the calcified valve leaflet of the patient, and the calcified valve leaflet 200 has higher hardness, so that the protruding part 201 can play a good supporting role when abutted with the calcified valve leaflet, and the reliability and the stability of the heart valve at the original heart valve can be ensured.

Specifically, in one embodiment, protrusion 20 and support unit 10 may be formed by knitting the same piece of knitting yarn, and they are continuous, so that the protrusions 20 and support unit 10 are referred to for convenience of description. In addition, each supporting unit 10 and a plurality of supporting units 10 can be braided by the same braided wire.

Referring to fig. 1 and 2, in some embodiments, each supporting unit 10 includes two first supporting bodies 101 respectively connected to different valve leaflets 200, and at least one connecting body 202 connected to the two first supporting bodies 101, and a first space 60 capable of being covered by a skirt connection is formed between the two first supporting bodies 101 and the connecting body 202.

In the above embodiment, each support unit 10 includes two first supports 101, and a first space 60 for skirt connection and covering is formed between the two first supports 101 and the connecting body 202, and when the skirt connection and covering is in the space, blood can only flow through the flow channel 103, so as to avoid the blood flowing through the peripheral side of the heart valve stent.

Referring to fig. 1 and 2, in some embodiments, the connecting body 202 is located in the upstream direction of the two first supporting bodies 101 and is continuous with one end of the protrusion 20 located in the upstream direction of the flow channel 103 to form the connecting body 202, wherein the upstream and downstream directions are defined according to the direction of blood passing through the flow channel 103.

In the above embodiment, the connecting body 202 is located at the upstream direction of the two first supporting bodies 101, that is, the direction of the connecting body 202 forms the blood inflow end, the direction of the two first supporting bodies 101 forms the blood outflow end, and blood firstly flows in through the direction of the connecting body 202 and then flows out from the direction of the first supporting body 101. And the connection body 202 is configured as a connection body 202, and the connection body 202 is continuous with one end of the projecting branch body 20 in the upstream direction of the flow passage 103, thereby forming the connection body 202 for connecting and covering the skirt.

Referring to fig. 4 and fig. 5, in some embodiments, the connecting body 202 includes at least one sub-connecting body 2021, and the at least one sub-connecting body 2021 is disposed on the connecting body 202 in an overlapping manner or in a spaced manner.

In the above embodiment, the connecting body 202 is connected to at least one sub-connecting body 2021, and the at least one sub-connecting body 2021 and the connecting body 202 are disposed in an overlapping manner or at an interval, so that the supporting strength of the connecting body 202 when supporting the original heart valve can be improved, and the stability of the heart valve stent during installation can be further improved.

Referring to fig. 1 and fig. 2, in some embodiments, two first supporting bodies 101 respectively extend from two ends of the connecting body 202 in a downstream direction, and the two first supporting bodies 101 are joined together.

In the above embodiment, the first ends of the two first supporting bodies 101 are respectively connected to the two ends of the connecting body 202, and the second ends extend in the downstream direction of the flow channel 103 and are joined together, so that a closed-loop space for connecting the covering skirts is formed between the two first supporting bodies 202.

For example, the second ends of the two first supporting bodies 101 and the connection manner between the two first supporting bodies 101 and the connection body 202 can be connected by riveting or welding a riveting tube.

Referring to fig. 1 and 2, in some embodiments, each support unit 10 includes a protrusion 20, and the protrusion 20 is located between two adjacent support units 10 along the circumferential direction of the channel 103.

In the above embodiment, the number of the protrusions 20 is plural, and each of the support units 10 includes the protrusion 20. Specifically, the plurality of protruding branches 20 are arranged at intervals and located between two adjacent supporting units 10 in the circumferential direction of the supporting body, so that when the protruding portions 201 of the plurality of protruding branches 20 contact with heart tissue (such as calcified valve leaflets), the reliability and stability of the heart valve stent after installation can be effectively improved.

Referring to fig. 1 and 2, in some embodiments, each supporting unit 10 includes two connectors 202 formed by protruding branches 20.

In the above embodiment, the connecting body 202 formed by the two protruding branches 20 of each supporting unit 10 is connected with each other (e.g. integrally connected, welded or riveted), so as to improve the stability of the sealing skirt connection covering the space formed between the connecting body 202 and the first supporting body 101, and to improve the integrity of the product, and to improve the reliability and stability of the heart valve stent supported on the original heart valve.

Referring to fig. 1 and 2, in some embodiments, a second space 70 is formed between each protrusion 20 and the first support 101 for passing the medical device.

In the above embodiment, the second space 70 for passing the medical device such as coronary stent is formed between each protruding branch 20 and the first supporting body 101 connected to the protruding branch, so as to facilitate the convenience of installing the medical device such as coronary stent after installing the heart valve stent.

In some embodiments, the protrusions 20 and the first support 101 are formed by weaving a piece of braided wire.

In the above embodiment, the protruding branch 20 and the first supporting body 101 are woven by a woven wire, and the two are continuous without secondary connection by welding or riveting, which is helpful for improving the production efficiency of the product and the integrity of the product.

Referring to fig. 1, 2 and 6, in some embodiments, the end of protrusion 20 downstream of flow channel 103 is formed with a connecting ring 30.

In the above embodiment, the protruding branch 20 is provided with the connection ring 30, and the connection ring 30 is located at the downstream of the flow channel 103 for connecting with the delivery system of the artificial heart valve stent, so as to realize the delivery and recovery of the heart valve stent by the delivery system.

Referring to fig. 1 and 2, in some embodiments, each of the supporting units 10 is connected to an adjacent supporting unit 10 by a riveting structure to form a first riveting node 40, in the first riveting node 40, the first supporting body 101 and the connecting body 202 of two adjacent supporting units 10 are arranged in parallel, and one end of the protruding branch 20 located upstream of the flow channel 103 is located in the first riveting node 40.

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

Referring to fig. 1 and 2, in some embodiments, the two first supporting bodies 101 of each supporting unit 10 are connected by a riveting structure and form the second riveting node 50.

In the above embodiment, the connection positions of the two first supports 101 of each support unit 10 located downstream of the flow channel 103 are connected by a riveting structure such as a riveting pipe to form the second riveting joint 50, so that the reliability of the connection of the ends of the two first supports 101 located downstream of the flow channel 103 in each support unit 10 is effectively ensured.

Referring to fig. 1, 2 and 3, in some embodiments, the protruding branch 20 includes a first connecting section, an abutting section and a second connecting section, which are connected in sequence, and the first connecting section is connected to the first riveting node 40; the first end of the abutting section is connected with the first connecting section, and the second end of the abutting section protrudes in the direction far away from the flow channel 103; one end of the second connection section is connected to the second end of the abutment section, and the other end is connected to the first support 101.

In the above embodiment, the protruding branch 20 includes a first connection section, an abutting section and a second connection section connected in sequence, wherein at least a portion of the first connection section is located in the first riveting node 40 and is continuous with the connection body 202; the first end of the abutting section is connected with the first connecting section, and the second end of the abutting section protrudes towards the outer side of the flow channel 103, so that a protruding part 201 capable of abutting with heart tissue is formed; one end of the second connecting section is connected to the abutting section, and the other end extends in a direction close to the flow channel 103, and is finally connected to the first support 101.

Referring to fig. 3, in some embodiments, the angle α between the abutting section and the axial direction of the flow channel is in the range of 10 ° to 150 °.

Referring to fig. 3, in some embodiments, the distance b between the second end of the abutting section and the first connecting section is in the range of 1mm to 20 mm.

In the above embodiment, the first connecting section is connected to the first riveting joint 40 along the axial direction of the flow channel, and the distance b between the second end of the abutting section and the first connecting section is set within the range of 1 mm-20 mm, so that on one hand, the abutting section can be ensured to abut against the heart tissue, and on the other hand, the abutting section can be prevented from protruding to the outside of the flow channel 103 for too long a distance, which may cause damage to the heart tissue.

In some embodiments, the implantable heart valve stent 100 is formed from at least one woven wire braid.

In the above embodiments, the braided wire may be a memory alloy wire, a nitinol wire, or the like, for example. When the heart valve support is formed by weaving one piece of weaving silk, the heart valve support is high in integrity and 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 braided wires comprise memory alloy wires.

In some embodiments, connector 202 is woven from a memory alloy wire of variable diameter; alternatively, a memory alloy tube is partially fitted around the outer periphery of the connector 202.

In the above embodiment, the connector 202 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 connector 202 to partially increase the diameter of the connector 202, 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 of the present application, a heart valve prosthesis is provided, which includes the implantable heart valve stent 100 according to any one of the embodiments of the first aspect; a leaflet 200 disposed within the flow channel 103 and connected to the first support 101 of the implantable heart valve stent 100; the first sealing skirt cloth 300 is connected and covered in a space formed between the two first supporting bodies 101 and the connecting body 202 of the heart valve stent; and a second sealing skirt 400 surrounding the outer circumferential side of the implantable heart valve stent 100.

In the above embodiment, the valve leaflet 200 is located in the flow channel 103 and connected to the first support 101 of the heart valve stent, 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 is opened 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 be closed in time to prevent the blood in the aorta from flowing back into the ventricle. The first sealing skirts 300 are arranged in the space formed between the two first supporting bodies 101 and the connecting body 202 of each supporting unit 10 of the heart valve stent, so that blood can be prevented from flowing through the peripheral side of 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 second sealing skirt cloth 400 is further arranged around the outer peripheral side of the heart valve stent 100, and the second sealing skirt cloth 400 is used for preventing blood from flowing back and avoiding perivalvular leakage.

In some embodiments, the second sealing skirt 400 has a disk shape, and the peripheral side of the second sealing skirt 400 is folded over 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 of the leaflet 200 and the first support 101 of the heart valve stent is one of adhesion, heat fusion, and polymer adhesion.

In the above embodiment, the leaflet 200 can be fixedly connected to the first support 101 of the heart valve stent 100 by one of adhesion, heat 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 feature, 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 features, structures, or characteristics may be combined in any suitable manner in one or more 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. An implantation type heart valve support is characterized in that,

the implanted heart valve support comprises a plurality of supporting units, and a flow channel for blood circulation is formed by the surrounding of the supporting units;

and at least one of the supporting units comprises a convex branch body, the convex branch body convexly extends in the direction far away from the flow passage to form a convex part which can be abutted with heart tissues, and the convex branch body extends in the upstream direction of the flow passage to form a connecting body which can be connected with the skirt cloth.

2. The implantable heart valve stent of claim 1, wherein each support unit comprises two first supports respectively connected with different valve leaflets, and a first space which can be covered by a skirt connection is formed between the two first supports and the connecting body.

3. The implantable heart valve stent of claim 2, wherein the connecting body 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 implantable heart valve stent of claim 2, wherein the connector comprises at least one sub-connector, and at least one sub-connector is disposed one of overlying and spaced from the connector.

5. The implantable heart valve stent as in any one of claims 2-4, wherein the two first supports extend in the downstream direction from respective ends of the connecting body, and the two first supports are joined together.

6. The implantable heart valve stent of any one of claims 1-4, wherein each of the support units comprises the projecting branch, and the projecting branch is located between two adjacent support units in the circumferential direction of the flow channel.

7. The implantable heart valve stent of claim 6, wherein each of said support units comprises two of said projecting branches, and the connectors formed by the two projecting branches are connected to each other.

8. The implantable heart valve stent of claim 7, wherein a second space is formed between each of the projections and the first support for passage of a medical device.

9. The implantable heart valve stent of any one of claims 2-4, wherein the projecting legs and the first support are woven from a single piece of braided wire.

10. The implantable heart valve stent of any one of claims 1-4, wherein the end of the projecting branch downstream of the flow channel is formed with a connection ring.

11. The implantable heart valve stent according to any one of claims 2-4, wherein each of the support units is connected with the adjacent support unit by a riveting structure to form a first riveting joint in which the first support body and the connecting body of the adjacent two support units are arranged in parallel.

12. The implantable 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 second riveted joint.

13. The implantable heart valve stent of any one of claims 2-4, wherein the protruding branch comprises a first connecting section, an abutment section, and a second connecting section connected in series, the first connecting section being connected in the first riveting node; the first end of the abutting section is connected with the first connecting section, and the second end of the abutting section protrudes in the direction far away from the flow channel; one end of the second connecting section is connected with the second end of the abutting section, and the other end of the second connecting section is connected with the first supporting body.

14. The implantable heart valve stent of claim 13, wherein the angle a between the abutment section and the axial direction of the flow channel is in the range of 10 ° to 150 °.

15. The implantable heart valve stent of claim 13, wherein a distance b between the second end of the abutment section and the first connection section is in a range of 1mm to 20 mm.

16. The implantable heart valve stent of any one of claims 1-4, wherein the implantable heart valve stent is formed from at least one woven wire.

17. The implantable heart valve stent of claim 16, wherein the braided wires comprise memory alloy wires.

18. The implantable heart valve stent of any one of claims 2-4, wherein the connector is woven from variable diameter memory alloy wires; or,

a memory alloy tube is partially embedded on the peripheral side of the connector.

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

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

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

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

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

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

22. The heart valve prosthesis of claim 19 or 20, wherein the leaflet is attached to the first support of the implantable heart valve stent by one of sewing, gluing, heat fusing, and polymer attachment.