CN115414157A

CN115414157A - Valve device and valve device system

Info

Publication number: CN115414157A
Application number: CN202211387817.XA
Authority: CN
Inventors: 潘炳跃; 呙小旭
Original assignee: Guangdong Hanyu Medical Technology Co ltd
Current assignee: Guangdong Hanyu Medical Technology Co ltd
Priority date: 2022-11-07
Filing date: 2022-11-07
Publication date: 2022-12-02
Anticipated expiration: 2042-11-07
Also published as: CN115414157B

Abstract

The embodiment of the application provides a valve device and a valve device system. In the valve device provided by the application, after the valve device is conveyed to a specified position, the first support is in an unfolded state, the first cylindrical sub-section is attached to the inner wall of an outflow channel in a left ventricle, the third cylindrical sub-section is attached to the inner wall of an ascending aorta, the second sub-section surrounding the artificial biological valve is fixed at the position of an original ascending aortic valve, the anchoring elements arranged at one end, close to the third sub-section, of the third sub-section are inserted into aortic sinuses between the native valve and the inner wall of the aorta, and the probability that the anchoring elements are inserted into the aortic sinuses can be increased by uniformly arranging the anchoring elements along the circumferential direction of the third sub-section, so that the fixing strength of the valve device and the position of the original ascending aortic valve can be improved, and the success rate of aortic valve replacement is further improved.

Description

Valve device and valve device system

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to a valve device and a valve device system.

Background

The aortic valve is a valve located between the left ventricle and the ascending aorta, and functions as a one-way valve, and is in an open state when the heart contracts so that blood can flow from the left ventricle to the ascending aorta, and is in a closed state when the heart relaxes so as to ensure that the blood in the ascending aorta does not flow back to the left ventricle.

In case of aortic valve lesion, the problem of aortic valve regurgitation is likely to occur, i.e. aortic valve insufficiency, part of blood flowing out of the left ventricle flows back to the left ventricle, and in case of large amount of regurgitated blood, the life and health of the patient are seriously threatened.

At present, one of the main means for inhibiting aortic regurgitation is to replace the native aortic valve with a prosthetic valve device, but in the aortic valve replacement process, the fixation strength of the existing prosthetic valve device and the position of the native ascending aortic valve is weak, the fixation difficulty of the prosthetic valve is high, and the success rate of aortic valve replacement is low.

Disclosure of Invention

The application provides a valve device and a valve device system aiming at the defects of the existing mode, and aims to solve the technical problem that in the prior art, the valve device is difficult to fix in the aortic valve replacement process.

In a first aspect, the present application provides a valve device comprising: a first stent, a bioprosthetic valve, and at least two anchors;

the first support comprises a first subsection, a second subsection and a third subsection which are sequentially connected and integrally formed, the second subsection is annularly provided with an artificial biological valve, and the first subsection, the second subsection and the third subsection are all in a cylindrical shape when the first support is in an unfolded state; the anchoring elements are arranged at one end of the third subsection close to the second subsection, and all the anchoring elements are uniformly distributed along the circumferential direction of the third subsection.

In a second aspect, the present application provides a valve device system comprising: the valve device and the delivery device for delivering the valve device provided in the first aspect;

in the delivery stage, the valve device is compressed and arranged in the delivery device; after the delivery device reaches the designated position, the first subsection, the second subsection and the third subsection of the first stent in the valve device are sequentially separated from the delivery device, so that the first subsection, the second subsection and the third subsection are in a cylindrical unfolding state, and an anchoring element arranged at one end of the third subsection close to the second subsection is inserted into the designated target.

The beneficial technical effects brought by the technical scheme provided by the embodiment of the application comprise:

in the valve device provided by the application, after the valve device is conveyed to a specified position, the first support is in an unfolded state, the first cylindrical sub-section is attached to the inner wall of an outflow channel in a left ventricle, the third cylindrical sub-section is attached to the inner wall of an ascending aorta, the second sub-section surrounding the artificial biological valve is fixed at the position of an original ascending aortic valve, the anchoring elements arranged at one end, close to the third sub-section, of the third sub-section are inserted into aortic sinuses between the native valve and the inner wall of the aorta, and the probability that the anchoring elements are inserted into the aortic sinuses can be increased by uniformly arranging the anchoring elements along the circumferential direction of the third sub-section, so that the fixing strength of the valve device and the position of the original ascending aortic valve can be improved, and the success rate of aortic valve replacement is further improved.

Additional aspects and advantages of the present application will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the present application.

Drawings

The foregoing and/or additional aspects and advantages of the present application will become apparent and readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which:

FIG. 1 is a schematic view of a valve device according to an embodiment of the present disclosure;

fig. 2 is a schematic structural diagram of a third sub-section of the first stent in the valve device shown in fig. 1 according to the embodiment of the present disclosure;

fig. 3 is a bottom view of the third subsection of fig. 2 at any time according to the embodiment of the present application.

Description of the reference numerals:

1-a first scaffold;

11-a first subsection; 12-a second sub-segment; 13-a third sub-section; 131-a connecting portion;

2-artificial biological valve;

3-anchor.

Detailed Description

Embodiments of the present application are described below in conjunction with the drawings in the present application. It should be understood that the embodiments set forth below in connection with the drawings are exemplary descriptions for explaining technical solutions of the embodiments of the present application, and do not limit the technical solutions of the embodiments of the present application.

As used herein, the singular forms "a", "an", "the" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, and/or components, but do not preclude the presence or addition of other features, components, and/or groups thereof, that may be implemented as required by the art. The term "and/or" as used herein means at least one of the items defined by the term, e.g., "a and/or B" may be implemented as "a", or as "B", or as "a and B".

To make the objects, technical solutions and advantages of the present application more clear, embodiments of the present application will be described in further detail below with reference to the accompanying drawings.

At present, in the aortic valve replacement process, the fixation strength between the existing artificial valve device and the left ventricle and ascending aorta is weak, the difficulty of fixing the artificial valve is high, and the success rate of aortic valve replacement is low.

Moreover, in the aortic valve replacement process, the radiography is completed through X-rays, the radiography shows a planar image, the structure of the aortic sinus is difficult to clearly show, so that an operator needs to frequently rotate the valve device, and the anchor of the valve device is inserted into the corresponding aortic sinus, which increases the difficulty of aortic valve replacement and further reduces the success rate of aortic valve replacement.

The present application provides a valve device and a valve device system, which aim to solve the above technical problems of the prior art.

The following describes the technical solutions of the present application and how to solve the above technical problems with specific embodiments. It should be noted that the following embodiments may be referred to, referred to or combined with each other, and the description of the same terms, similar features, similar implementation steps and the like in different embodiments is not repeated.

The embodiment of the application provides a valve device, and the structural schematic diagram of the valve device is shown in fig. 1. The valve device comprises: the method comprises the following steps: a first stent 1, a bioprosthetic valve 2, and at least two anchors 3.

In the embodiment of the application, the first support 1 comprises a first subsection 11, a second subsection 12 and a third subsection 13 which are sequentially connected and integrally formed, the second subsection 12 is annularly provided with the artificial biological valve 2, and the first subsection 11, the second subsection 12 and the third subsection 13 are all in a cylindrical shape when the first support 1 is in a spreading state; the anchoring elements 3 are arranged at one end of the third subsection 13 close to the second subsection 12, and all the anchoring elements 3 are evenly distributed along the circumferential direction of the third subsection 13.

In the valve device provided by the application, after the valve device is conveyed to a specified position, the first stent 1 is in a deployed state, the cylindrical first subsection 11 is attached to the inner wall of an outflow passage in a left ventricle, the cylindrical third subsection 13 is attached to the inner wall of an ascending aorta, the second subsection 12 encircling the bioprosthetic valve 2 is fixed at the position of an original ascending aortic valve, the aortic sinuses, which are arranged at one end, close to the second subsection 12, of the third subsection 13 are inserted into the position between the native valve and the inner wall of the aorta, and by arranging the anchoring elements 3 uniformly and circumferentially distributed along the third subsection 13, the probability that the anchoring elements 3 are inserted into the aortic sinuses can be increased, so that the fixing strength of the position where the valve device and the original ascending aortic valve are located can be improved, and the success rate of aortic valve replacement is further improved.

In the embodiment of the present application, the aortic valve replacement is taken as an example to illustrate the working principle of the valve device provided in the embodiment of the present application. In the embodiment of the present application, as shown in fig. 1, the first support 1 includes a first sub-section 11, a second sub-section 12, and a third sub-section 13 that are sequentially connected and integrally formed, and the first sub-section 11, the second sub-section 12, and the third sub-section 13 that are in a cylindrical state are connected to form the cylindrical first support 1.

As shown in fig. 1, the second sub-segment 12 located in the middle of the first stent 1 is surrounded by the bioprosthetic valve 2, the bioprosthetic valve 2 is used to replace a native aortic valve, one end of the third sub-segment 13 close to the second sub-segment 12 is provided with a plurality of anchoring elements 3, and each anchoring element 3 is uniformly arranged along the circumferential direction of the third sub-segment 13. In the embodiment of the application, the position is the communication part of the outflow tract of the left ventricle and the ascending aorta, and the communication part comprises the outflow tract of part of the left ventricle, the original ascending aorta valve and part of the ascending aorta. After the valve device is delivered to the designated position of the human body, the second cylindrical sub-section 12 is positioned at the primary ascending aortic valve, so that the bioprosthetic valve 2 surrounded by the second sub-section 12 can replace the primary aortic valve. Anchoring elements 3 are inserted into the aortic sinuses between the original ascending aortic valve and the inner wall of the aorta, so that the first support 1 can be fixed at a designated position in a human body.

Optionally, the third subsection 13 is provided with three anchors 3 near one end of the second subsection 12.

After the valve device is conveyed to the designated position of the human body, the cylindrical first subsection 11 positioned at one end of the second subsection 12 is attached to the inner wall of the outflow tract in the left ventricle, and the cylindrical third subsection 13 positioned at the other end of the second subsection 12 is attached to the inner wall of the ascending aorta, so that the contact area of the first stent 1 and the designated position can be increased, and the fixing strength of the first stent 1 can be guaranteed.

Optionally, in the embodiment of the present application, the first support 1 is formed by integrally molding the first subsection 11, the second subsection 12, and the third subsection 13, so that the structural strength of the first support 1 can be ensured, and the production rate of the first support 1 can be improved. Moreover, after the first bracket 1 is fixed at the designated position, the probability that the first bracket 1 entirely falls off can be reduced.

Optionally, in this embodiment of the present application, the artificial biologic valve 2 may include a biologic material such as bovine pericardium and porcine pericardium, and may further include a polymer material such as silicone rubber, polyurethane, and polytetrafluoroethylene. Optionally, in the present embodiment, the bioprosthetic valve 2 may include three independent valves, each connected to the inner peripheral wall of the second subsection 12; optionally, the bioprosthetic valve 2 may further include an integrally formed valve structure, a peripheral wall of the valve structure is connected with an inner peripheral wall of the second subsection 12, and three valve leaflets capable of being closed and opened are arranged in the middle of the valve structure.

Alternatively, in the present embodiment, the bioprosthetic valve 2 may be sutured to the second sub-segment 12 with sutures, such that the bioprosthetic valve 2 is fixedly connected to the second sub-segment 12.

Optionally, as shown in fig. 2 and 3, in one embodiment of the present application, the third subsection 13 is uniformly circumferentially arranged with at least six anchors 3.

In the embodiment of the present application, in order to facilitate visual understanding of the arrangement relationship between the third subsection 13 and the anchoring member 3 in the first bracket 1, as shown in fig. 2 and 3, a front view and a bottom view of the third subsection 13 are shown. As shown in fig. 3, six anchors 3 are evenly arranged in the circumferential direction of the third subsection 13. In fig. 3, the connection portion 131 is not marked for clarity of the arrangement of the third subsection 13 and the anchoring member 3.

As understood by those skilled in the art, the aortic sinuses of the human body often include the left, right and posterior sinuses. In the embodiment of the present application, one end of the third subsection 13 close to the second subsection 12 is provided with at least six anchoring elements 3, and each anchoring element 3 is uniformly arranged along the circumferential direction of the third subsection 13, thereby in the process of implanting the valve device into the human body, on the premise of ensuring that the left sinus, the right sinus and the rear sinus are all inserted with one anchoring element 3 at least, the rotation of the operator can be reduced, the frequency of the first stent 1 can be adjusted, the implantation difficulty of the valve device can be reduced, the success rate of aortic valve replacement can be improved, and meanwhile, the time required for implanting the valve device can be shortened.

Alternatively, as shown in fig. 1-3, in one embodiment of the present application, anchor member 3 is connected to third subsection 13 at one end, and is distal to third subsection 13 and toward second subsection 12 at the other end; the angle between the plane in which the anchoring member 3 lies and the radial plane of the second subsection 12 is acute.

In the embodiment of the present application, as shown in fig. 1, one end of the anchor 3 is connected to the third subsection 13, and the other end of the anchor 3 is connected to the third subsection 13 and faces the second subsection 12, so that an included angle between a plane where the anchor 3 is located and a radial plane of the second subsection 12 is an acute angle, and in the implantation process of the valve device, the anchor 3 can be ensured to be gradually inserted into the aortic sinus along a direction in which the ascending aorta points to the left ventricular outflow tract, without affecting other human tissues except the aortic sinus, and the injury to other human tissues can be reduced.

Moreover, when the valve device has a problem and needs to be taken out of a human body, the aortic sinus can be gradually pulled out along the direction of the left ventricular outflow tract pointing to the ascending aorta, the valve device can be conveniently recovered, and the damage to a patient can be reduced.

Optionally, in the embodiment of the present application, the other end of the anchor 3, i.e. the free end of the anchor 3, is of a blunt structure, i.e. the free end is in the shape of a rounded corner, an arc, etc. so as to avoid the free end of the anchor 3 from stabbing the aortic sinus.

Optionally, as shown in fig. 1 and fig. 2, the included angle between the anchor 3 and the third sub-segment 13 is an acute angle, and by the cooperation of the anchor 3 and the third sub-segment 13, after the valve device reaches the designated position, the V-shaped structure formed by the anchor 3 and the third sub-segment 13 can assist in clamping the native aortic valve, so that the fixing strength of the valve device can be further enhanced, and the probability of displacement and falling-off of the valve device can be reduced.

Optionally, as shown in fig. 1, in an embodiment of the present application, the first sub-section 11, the second sub-section 12, and the third sub-section 13 are coaxially arranged, and maximum radial sizes of the first sub-section 11 and the third sub-section 13 are greater than a radial size of the second sub-section 12.

In the embodiment of the present application, as shown in fig. 1, a first subsection 11, a second subsection 12, and a third subsection 13 which are in a deployed state and are in a cylindrical shape are coaxially arranged, and a maximum radial dimension of the first subsection 11 is greater than a radial dimension of the second subsection 12, and a maximum radial dimension of the third subsection 13 is greater than a radial dimension of the second subsection 12, so that the first stent 1 in the deployed state is in a dumbbell shape with a narrow middle part and wide ends.

It will be appreciated by those skilled in the art that the diameter of the ascending aorta and the diameter of the outflow tract in the left ventricle are substantially the same, and that due to the presence of the native aortic valve, the diameter at the location of the native aortic valve is significantly smaller than the diameter of the ascending aorta and the diameter of the outflow tract in the left ventricle. In the embodiment of the present application, by setting the maximum radial dimensions of the first subsection 11 and the third subsection 13 to be larger than the radial dimension of the second subsection 12, the static friction force between the first subsection 11 and the inner wall of the outflow tract can be increased, the static friction force between the third subsection 13 and the inner wall of the ascending aorta can be increased, the fixing strength between the first subsection 11 and the outflow tract and the fixing strength between the third subsection 13 and the ascending aorta can be further enhanced, the fixing strength of the valve device can be further enhanced, and the shedding probability of the valve device can be reduced.

Optionally, as shown in fig. 1, in an embodiment of the present application, the radial dimension of the first subsection 11 is gradually reduced along a direction in which the first subsection 11 is close to the second subsection 12; the radial dimension of the third subsection 13 decreases in a direction in which the plane of the geometrical centre of the third subsection 13 points in the radial plane of the second subsection 12.

In the embodiment of the present application, as shown in fig. 1, the radial dimensions of the first subsection 11 and the third subsection 13 are gradually changed. Optionally, in a direction in which the first sub-section 11 is close to the second sub-section 12, the radial dimension of the first sub-section 11 is gradually reduced until the radial dimension of the first sub-section 11 is equal to the radial dimension of the second sub-section 12, as shown in fig. 1, the first sub-section 11 is in a cone shape, so that smooth transition of a connection portion between the first sub-section 11 and the second sub-section 12 can be ensured, and discomfort caused by a sharp connection portion between the first sub-section 11 and the second sub-section 12 to a wall of an outflow tract can be avoided.

Optionally, in a direction that a plane where a geometric center of the third sub-section 13 is located points at a radial plane of the second sub-section 12, a radial dimension of the third sub-section 13 is gradually reduced until the radial dimension of the third sub-section 11 is equal to the radial dimension of the second sub-section 12, so that smooth transition of a connecting portion between the second sub-section 12 and the third sub-section 13 can be ensured, and discomfort to a vessel wall of an ascending aorta due to an abrupt connection of the connecting portion between the second sub-section 12 and the third sub-section 13 can be avoided.

Optionally, in an embodiment of the present application, in a direction in which the third sub-section 13 is close to the second sub-section 12, a radial dimension of the third sub-section 13 gradually decreases until the radial dimension of the third sub-section 13 is equal to the radial dimension of the second sub-section 12, that is, an unfolded form of the third sub-section 13 is the same as that of the first sub-section 11, and is also a cone.

Optionally, as shown in fig. 1 and fig. 2, in an embodiment of the present application, the other end of the third subsection 13, which is far away from the second subsection 12, is provided with at least two connecting portions 131, and each connecting portion 131 is uniformly arranged along the circumferential direction of the third subsection 13.

In the embodiment of the present application, as shown in fig. 1 and fig. 2, the other end of the third sub-segment 13, which is far away from the second sub-segment 12, is provided with a connecting portion 131, the connecting portion 131 is used for being detachably connected with a delivery device, during a delivery stage of the valve device, the delivery device can provide a pushing force to the connecting portion 131, so that the valve device is detached from a delivery catheter of the delivery device, and after replacement of the valve device is completed, the delivery device is detached from the connecting portion 131, so as to facilitate withdrawing the delivery device out of the body.

Optionally, as shown in fig. 1 and fig. 2, the other end of the third sub-section 13, which is far away from the second sub-section 12, is provided with three connecting portions 131, and the three connecting portions 131 are uniformly arranged along the circumferential direction of the third sub-section 13, so that it can be ensured that the thrust provided by the delivery device is uniformly applied to the first stent 1, the valve device is conveniently and smoothly separated from the delivery catheter, and the operation difficulty is reduced.

It should be noted that, a person skilled in the art may select the number of the connecting portions 131 according to actual requirements, and the valve device provided in the present application is not limited to the number of the connecting portions 131.

Optionally, as shown in fig. 1, in an embodiment of the present application, a radial dimension of the third sub-section 13 gradually decreases along a plane where a geometric center of the third sub-section 13 is located and in a direction toward a plane where another end of the third sub-section 13, which is far away from the second sub-section 12, is located.

In the embodiment of the present application, as shown in fig. 1 and fig. 2, the radial dimension of the third sub-section 13 gradually decreases along the direction in which the plane where the geometric center of the third sub-section 13 is located points to the radial plane of the second sub-section 12; the plane of the geometric center of the third subsection 13 points to the direction of the plane of the other end of the third subsection 13 far away from the second subsection 12, and the radial size of the third subsection 13 is gradually reduced. That is, the third subsection 13 in the unfolded state is in a drum shape with a wide middle part and narrow ends.

In the embodiment of the present application, as shown in fig. 1, by providing the third sub-section 13 with the shape shown in fig. 1, the probability of contact between the connecting portion 131 and the ascending aorta vessel wall can be reduced, the connecting portion 131 can be prevented from irritating the ascending aorta vessel wall, and discomfort caused by the connecting portion 131 to the ascending aorta vessel wall can be avoided.

Moreover, during implantation of the valve device, the connection portion 131 can be prevented from stimulating the ascending aortic wall during the insertion of the anchoring member 3 into the aortic sinus by the operator. In the process of recovering the valve device, the connecting part 131 can be prevented from penetrating into the ascending aorta tube wall, so that the valve device can be recovered through the aorta, and the recovery difficulty of the valve device is reduced.

Optionally, as shown in fig. 1, in an embodiment of the present application, one end of the connecting portion 131 is connected to the third subsection 13, and the other end is far away from the third subsection 13; the angle between the plane of the connection 131 and the radial plane of the third subsection 13 is acute. Thereby, the contact probability of the connecting part 131 and the ascending aorta vessel wall can be reduced, the connecting part 131 can be prevented from stimulating the ascending aorta vessel wall, discomfort caused by the connecting part 131 to the ascending aorta vessel wall is avoided, and the implantation and recovery of the valve device are facilitated.

Optionally, as shown in fig. 1, a circumferential dimension of the other end of the connecting portion 131 along the third sub-segment 13 is greater than a circumferential dimension of one end of the connecting portion 131 along the third sub-segment 13, so as to facilitate connection between the connecting portion 131 and the delivery device, optionally, the other end of the connecting portion 131 may be provided with a through hole, the guide wire is inserted into the through hole, and after the implantation of the valve device is completed, the guide wire is directly pulled out of the through hole.

Alternatively, as shown in fig. 1, in one embodiment of the present application, the first stent 1 comprises a shape memory material; the first subsection 11, the second subsection 12 and the third subsection 13 each comprise a plurality of connected grid cells; in each grid cell located at the end of the third subsection 13 close to the end of the second subsection 12, at least two grid cells are bent at the end close to the second subsection 12 to form the anchoring element 3.

In the embodiment of the present application, the first stent 1 comprises a shape memory material, so that the first stent 1 can self-expand after being implanted to make the first stent 1 in a deployed state, thereby achieving the purpose of supporting the passage between the outflow tract and the ascending aorta. Alternatively, the shape memory material may comprise a shape memory alloy, a shape memory polymer, or the like.

Optionally, as shown in fig. 1, the first subsection 11, the second subsection 12, and the third subsection 13 each include a plurality of connected grid units, and when the first stent 1 is in the expanded state, the plurality of connected grid units are connected to form a cylindrical grid stent with a narrow middle part and wide ends.

Optionally, in the embodiment of the present application, the first stent 1 is a grid stent formed by laser cutting a tubular object made of a material with a shape memory property, so that the first subsection 11, the second subsection 12 and the third subsection 13 are integrally formed.

Optionally, in an embodiment of the present application, the first sub-segment 11 of the first stent 1 is provided with a coating, and since blood is emitted from the outflow tract of the left ventricle to the ascending aorta, the perivalvular leak phenomenon can be reduced by providing a coating on the first sub-segment 11. Optionally, the covering membrane is made of a high molecular material or a biological tissue membrane.

Optionally, in the embodiment of the present application, both the second subsection 12 and the third subsection 13 may be provided with a coating.

Based on the same inventive concept, embodiments of the present application provide a valve device system including any one of the valve devices provided in the above embodiments and a delivery device for delivering the valve device.

In the embodiment of the application, in the delivery stage, the valve device is compressed and installed in the delivery device; after the delivery device reaches the designated position, the first subsection 11, the second subsection 12 and the third subsection 13 of the first stent 1 in the valve device are sequentially separated from the delivery device, so that the first subsection 11, the second subsection 12 and the third subsection 13 are in a cylindrical unfolding state, and the anchoring element 3 arranged at one end of the third subsection 13 close to the second subsection 12 is inserted into the designated target.

In embodiments of the present application, the delivery device may include a delivery catheter, and the valve device is compressively mounted within the delivery catheter of the delivery device during the delivery phase. After the delivery catheter of the delivery device reaches a designated position through an artery, applying a pushing force to the valve device to push the first sub-segment 11 out of the delivery catheter, so that the first sub-segment 11 in a unfolding state can be attached to the inner peripheral wall of the outflow tract of the left ventricle; continuously applying pushing force to the valve device, pushing the second sub-section 12 out of the delivery catheter, so that the second sub-section 12 in the unfolded state can be attached to the inner peripheral wall of the position of the native aortic valve; the pushing force is continuously applied to the valve device to push the third subsection 13 out of the delivery catheter, so that the anchoring element 3 arranged at one end of the third subsection 13 close to the second subsection 12 is inserted into the designated target, namely, the anchoring element 3 is inserted into the aortic sinus, and the third subsection 13 in the unfolding state can be attached to the inner peripheral wall of the ascending aorta.

Optionally, in an embodiment of the present application, the valve device further includes a transmission member detachably connected to the connection portion 131 disposed at an end of the third sub-segment 13 away from the second sub-segment 12.

In the embodiment of the present application, the transmission member is detachably connected to the connecting portion 131, and can provide a pushing force to the connecting portion 131, during the delivery stage, the transmission member and the valve device are compressed and installed in the delivery catheter together, and after the delivery device reaches the designated position, the transmission member controls the first subsection 11, the second subsection 12 and the third subsection 13 to sequentially separate from the delivery catheter.

Optionally, the transmission member may also provide a pulling force to the connecting portion 131 to adjust the position of the anchoring member 3 relative to the aortic sinus by the transmission member during adjustment of the insertion of the anchoring member 3 into the aortic sinus, so as to facilitate the insertion of the anchoring member 3 into the aortic sinus. Simultaneously, when valve device is retrieved to needs, provide pulling force through the driving medium to connecting portion 131, can directly retrieve valve device through the aorta, reduce valve device's the recovery degree of difficulty.

By applying the embodiment of the application, at least the following beneficial effects can be realized:

1. in the valve device provided by the application, after the valve device is conveyed to a designated position, the first support 1 is in a deployed state, the cylindrical first sub-section 11 is attached to the inner wall of an outflow channel in a left ventricle, the cylindrical third sub-section 13 is attached to the inner wall of an ascending aorta, the second sub-section 12 surrounding the artificial biological valve 2 is fixed at the position of an original ascending aortic valve, the aortic sinuses arranged between the native valve and the inner wall of the aorta are inserted into the anchoring elements 3 at one end, close to the second sub-section 12, of the third sub-section 13, and the anchoring elements 3 are uniformly distributed along the circumferential direction of the third sub-section 13, so that the probability that the anchoring elements 3 are inserted into the aortic sinuses can be increased, the fixing strength of the valve device and the position of the original ascending aortic valve can be improved, and the success rate of aortic valve replacement can be further improved.

2. In the valve device provided by the embodiment of the application, the first sub-section 11, the second sub-section 12 and the third sub-section 13 are coaxially arranged, and the maximum radial sizes of the first sub-section 11 and the third sub-section 13 are larger than the radial size of the second sub-section 12, so that the static friction force between the first sub-section 11 and the inner wall of the outflow tract can be increased, the static friction force between the third sub-section 13 and the inner wall of the ascending aorta can be increased, the fixing strength between the first sub-section 11 and the outflow tract and the fixing strength between the third sub-section 13 and the ascending aorta can be enhanced, the fixing strength of the valve device can be further enhanced, and the falling probability of the valve device can be reduced.

Those of skill in the art will appreciate that the various operations, methods, steps in the processes, acts, or solutions discussed in this application can be interchanged, modified, combined, or eliminated. Further, other steps, measures, or schemes in various operations, methods, or flows that have been discussed in this application can be alternated, altered, rearranged, broken down, combined, or deleted. Further, the steps, measures, and schemes in the various operations, methods, and flows disclosed in the present application in the prior art can also be alternated, modified, rearranged, decomposed, combined, or deleted.

In the description of the present application, the directions or positional relationships indicated by the words "center", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like are for convenience of description or simplification based on the exemplary directions or positional relationships shown in the drawings, and do not indicate or imply that the devices or components referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be construed as limiting the present application.

The terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, the meaning of "a plurality" is two or more unless otherwise specified.

In the description of the present application, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.

In the description herein, particular features, structures, materials, or characteristics may be combined in any suitable manner in any one or more embodiments or examples.

The foregoing is only a part of the embodiments of the present application, and it should be noted that it is within the scope of the embodiments of the present application that other similar implementation means based on the technical idea of the present application can be adopted by those skilled in the art without departing from the technical idea of the present application.

Claims

1. A valve device, comprising: a first scaffold (1), a bioprosthetic valve (2) and at least two anchors (3);

the first support (1) comprises a first subsection (11), a second subsection (12) and a third subsection (13) which are sequentially connected and integrally formed, the artificial biological valve (2) is annularly arranged on the second subsection (12), and the first subsection (11), the second subsection (12) and the third subsection (13) are all cylindrical when the first support (1) is in a spreading state; the anchoring elements (3) are arranged at one end of the third subsection (13) close to the second subsection (12), and the anchoring elements (3) are uniformly distributed along the circumferential direction of the third subsection (13).

2. The valve device according to claim 1, characterized in that said third subsection (13) is uniformly circumferentially arranged with at least six of said anchors (3).

3. The valve device according to claim 1, wherein the anchor (3) is connected to the third subsection (13) at one end and is directed away from the third subsection (13) and towards the second subsection (12) at the other end;

the plane of the anchoring element (3) and the radial plane of the second subsection (12) form an acute angle.

4. The valve device according to claim 1, wherein the first subsection (11), the second subsection (12) and the third subsection (13) are coaxially arranged, and the maximum radial dimension of the first subsection (11) and the maximum radial dimension of the third subsection (13) are larger than the radial dimension of the second subsection (12).

5. The valve device according to claim 4, characterized in that the radial dimension of the first subsection (11) decreases gradually in the direction in which the first subsection (11) approaches the second subsection (12);

the radial size of the third subsection (13) is gradually reduced along the direction that the plane of the geometric center of the third subsection (13) points to the radial plane of the second subsection (12).

6. The valve device according to claim 1, wherein the other end of the third subsection (13) far away from the second subsection (12) is provided with at least two connecting parts (131), and the connecting parts (131) are uniformly arranged along the circumferential direction of the third subsection (13).

7. The valve device according to claim 6, characterized in that the radial dimension of the third subsection (13) decreases gradually along the plane of the geometric center of the third subsection (13) towards the direction of the plane of the other end of the third subsection (13) away from the second subsection (12).

8. The valve device according to claim 1, wherein the first stent (1) comprises a shape memory material; -said first subsection (11), said second subsection (12) and said third subsection (13) each comprise a plurality of connected grid cells;

at least two grid units in each grid unit of the third subsection (13) close to one end of the second subsection (12) are bent to form an anchoring piece (3) close to one end of the second subsection (12).

9. A valve device system, comprising: the valve device of any one of claims 1-8 and a delivery device for delivering the valve device;

in a delivery stage, the valve device is compressively mounted within the delivery device; after the delivery device reaches a designated position, a first subsection (11), a second subsection (12) and a third subsection (13) of a first support (1) in the valve device sequentially depart from the delivery device, so that the first subsection (11), the second subsection (12) and the third subsection (13) are in a cylindrical unfolding state, and the anchoring element (3) arranged at one end, close to the second subsection (12), of the third subsection (13) is inserted into a designated target.

10. The valve device system according to claim 9, further comprising a transmission member detachably connected to a connecting portion (131) provided at an end of the third subsection (13) remote from the second subsection (12).