CN115414157B

CN115414157B - Valve device and valve device system

Info

Publication number: CN115414157B
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: 2023-07-04
Anticipated expiration: 2042-11-07
Also published as: CN115414157A

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 the designated position, the first support is in the unfolding state, the first cylindrical subsection is attached to the inner wall of the outflow channel in the left ventricle, the third cylindrical subsection is attached to the inner wall of the ascending aorta, the second subsection Duan Gu of the annular artificial biological valve is fixed at the position of the original ascending aortic valve, the anchoring pieces arranged at one end, close to the second subsection, of the third subsection are inserted into the aortic sinuses between the original aortic valve and the inner wall of the aorta, and the probability that the anchoring pieces are inserted into the aortic sinuses can be increased by uniformly arranging the anchoring pieces along the circumferential direction of the third subsection, so that the fixing strength of the position of the valve device and the original ascending aortic valve can be improved, and the success rate of aortic valve replacement is 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 positioned between the left ventricle and the ascending aorta and plays a role of a one-way valve, and the aortic valve is in an open state when the heart contracts, so that blood can flow from the left ventricle to the ascending aorta, and the aortic valve is in a closed state when the heart relaxes, so that the blood in the ascending aorta can not flow back to the left ventricle.

When the aortic valve is diseased, the aortic valve is likely to be regurgitated, that is, the aortic valve is not closed completely, and part of blood flowing out of the left ventricle is regurgitated back to the left ventricle, so that the life health of a patient is seriously threatened under the condition that the amount of the regurgitated blood is large.

At present, one of the main means for inhibiting aortic valve regurgitation is to replace a native aortic valve with an artificial valve device, however, in the aortic valve replacement process, the fixing strength of the existing artificial valve device at the position where the original ascending aortic valve is located is weak, the fixing difficulty of the artificial 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 the valve device is difficult to fix in the aortic valve replacement process in the prior art.

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

the first bracket comprises a first subsection, a second subsection and a third subsection which are sequentially connected into a whole, wherein the second subsection is provided with an artificial biological valve in a surrounding mode, and the first subsection, the second subsection and the third subsection are cylindrical when the first bracket is in an unfolding state; the anchoring pieces are arranged at one end of the third sub-section, which is close to the second sub-section, and the anchoring pieces are uniformly distributed along the circumferential direction of the third sub-section.

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 above;

during the delivery phase, the valve device is compressively mounted within the delivery device; after the conveying device reaches the designated position, the first sub-section, the second sub-section and the third sub-section of the first bracket in the valve device are sequentially separated from the conveying device, so that the first sub-section, the second sub-section and the third sub-section are in a cylindrical unfolding state, and an anchoring piece arranged at one end, close to the second sub-section, of the third sub-section is inserted into the designated target.

The beneficial technical effects that technical scheme that this application embodiment provided brought include:

in the valve device provided by the application, after the valve device is conveyed to the designated position, the first support is in the unfolding state, the first cylindrical subsection is attached to the inner wall of the outflow channel in the left ventricle, the third cylindrical subsection is attached to the inner wall of the ascending aorta, the second subsection Duan Gu of the annular artificial biological valve is fixed at the position of the original ascending aortic valve, the anchoring pieces arranged at one end, close to the second subsection, of the third subsection are inserted into the aortic sinuses between the original aortic valve and the inner wall of the aorta, and the probability that the anchoring pieces are inserted into the aortic sinuses can be increased by uniformly arranging the anchoring pieces along the circumferential direction of the third subsection, so that the fixing strength of the position of the valve device and the original ascending aortic valve can be improved, and the success rate of aortic valve replacement is improved.

Additional aspects and advantages of the 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 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, in which:

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

FIG. 2 is a schematic view of a third sub-section of the first stent of the valve device of FIG. 1 according to an embodiment of the present application;

fig. 3 is a bottom view of the third subsection of fig. 2 at any time provided in accordance with an embodiment of the present application.

Reference numerals illustrate:

1-a first bracket;

11-a first subsection; 12-a second subsection; 13-a third subsection; 131-a connection;

2-artificial biological valve;

3-anchors.

Detailed Description

Embodiments of the present application are described below with reference to the drawings in the present application. It should be understood that the embodiments described below with reference to the drawings are exemplary descriptions for explaining the technical solutions of the embodiments of the present application, and the technical solutions of the embodiments of the present application are not limited.

As used herein, the singular forms "a", "an", "the" and "the" are intended to include the plural forms as well, unless expressly stated otherwise, as understood by those skilled in the art. It should 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, all as may be practiced in the art. The term "and/or" as used herein refers to 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".

For the purpose of making the objects, technical solutions and advantages of the present application more apparent, the 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 fixing strength between the existing artificial valve device and the left ventricle and the ascending aorta is weak, the artificial valve is difficult to fix, and the success rate of aortic valve replacement is low.

In addition, in the aortic valve replacement process, radiography is completed through X rays, a planar image is displayed in a radiography mode, the structure of the aortic sinus is difficult to clearly display, an operator needs to frequently rotate the valve device, an anchor of the valve device is inserted into the corresponding aortic sinus, the difficulty of aortic valve replacement is increased, and the success rate of aortic valve replacement is further reduced.

The valve device and the valve device system provided by the application aim to solve the technical problems in the prior art.

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

Embodiments of the present application provide a valve device, a schematic structural diagram of which is shown in fig. 1. The valve device comprises: comprising the following steps: a first stent 1, an artificial bioprosthetic valve 2 and at least two anchors 3.

In the embodiment of the application, the first bracket 1 comprises a first subsection 11, a second subsection 12 and a third subsection 13 which are sequentially connected into a whole, 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 cylindrical when the first bracket 1 is in an unfolding state; the anchoring elements 3 are arranged at one end of the third sub-section 13 close to the second sub-section 12, and the anchoring elements 3 are uniformly distributed along the circumferential direction of the third sub-section 13.

In the valve device provided by the application, after the valve device is conveyed to the designated position, the first support 1 is in a unfolding state, the first cylindrical subsection 11 is attached to the inner wall of the outflow channel in the left ventricle, the third cylindrical subsection 13 is attached to the inner wall of the ascending aorta, the second subsection 12 of the annular artificial biological valve 2 is fixed at the position of the original ascending aortic valve, the anchoring piece 3 arranged at one end, close to the second subsection 12, of the third subsection 13 is inserted into the aortic sinus between the original valve and the inner wall of the aorta, and through arranging the anchoring pieces 3 uniformly along the circumferential direction of the third subsection 13, the probability that the anchoring pieces 3 are inserted into the aortic sinus can be increased, so that the fixing strength of the position of the valve device and the original ascending aortic valve can be improved, and the success rate of aortic valve replacement is further improved.

In the embodiments of the present application, the operation principle of the valve device provided in the embodiments of the present application is described by taking aortic valve replacement as an example. In this embodiment, as shown in fig. 1, the first bracket 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 shape in an expanded state are connected to form the first bracket 1 that is in a cylindrical shape.

As shown in fig. 1, the second subsection 12 positioned in the middle of the first stent 1 is surrounded by an artificial biological valve 2, the artificial biological valve 2 is used for replacing a native aortic valve, one end of the third subsection 13, which is close to the second subsection 12, is provided with a plurality of anchoring pieces 3, and the anchoring pieces 3 are uniformly distributed along the circumferential direction of the third subsection 13. In the embodiment of the application, the designated position is a communication position between the outflow tract of the left ventricle and the ascending aorta, and comprises a part of the outflow tract of the left ventricle, an original ascending aortic valve and a part of the ascending aorta. After the valve device is delivered to the prescribed location of the human body, the second subsection 12, which is cylindrical, is positioned in the original ascending aortic valve so that the prosthetic valve 2, which is encircled by the second subsection 12, can replace the original aortic valve. The aortic sinus between the original ascending aortic valve and the inner wall of the aorta is inserted with the anchoring pieces 3, so that the first support 1 can be fixed at a designated position in the human body, in the embodiment of the application, each anchoring piece 3 is uniformly distributed along the circumference of the third subsection 13, so that the probability that each aortic sinus is inserted with the anchoring piece 3 can be increased, the fixing strength of the valve device and the position where the original ascending aortic valve is located can be improved, and the success rate of aortic valve replacement is further improved.

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

Moreover, after the valve device is delivered to the specified position of the human body, the first cylindrical 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 third cylindrical 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 between the first stent 1 and the specified position can be increased, and the fixing strength of the first stent 1 can be ensured.

Optionally, in the embodiment of the present application, the first sub-section 11, the second sub-section 12 and the third sub-section 13 are integrally formed to form the first support 1, 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. Further, after the first bracket 1 is fixed to the predetermined position, the probability of the first bracket 1 falling off as a whole can be reduced.

Optionally, in the embodiment of the present application, the bioprosthetic valve 2 may include biological materials such as bovine pericardium and porcine pericardium, and may also include polymer materials such as silicone rubber, polyurethane, and polytetrafluoroethylene. Alternatively, in embodiments of the present application, the prosthetic valve 2 may comprise three separate pieces of valve, each piece of valve being connected to the inner peripheral wall of the second subsection 12; optionally, the prosthetic valve 2 may further comprise an integrally formed valve structure, the peripheral wall of which is connected to the inner peripheral wall of the second subsection 12, the middle of which comprises three leaflets that can be closed and opened.

Alternatively, in the embodiment of the present application, the prosthetic valve 2 may be sewn to the second subsection 12 by a suture, such that the prosthetic valve 2 is fixedly connected to the second subsection 12.

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

In this embodiment, for facilitating visual understanding of the arrangement relationship between the third subsection 13 and the anchor 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 illustrated. As shown in fig. 3, six anchors 3 are uniformly arranged along the circumferential direction of the third subsection 13. In fig. 3, the connection 131, which is obscured, is not marked for clarity in showing the arrangement of the third subsection 13 and the anchor 3.

Those skilled in the art will appreciate that the aortic sinuses of the human body often include the left sinus, the right sinus, and the posterior sinus. In this embodiment, the one end that third subsection 13 is close to second subsection 12 is provided with six at least anchors 3, and each anchor 3 evenly arranges along the circumference of third subsection 13 to under the in-process of valve device implantation human body, under the prerequisite that ensures that left sinus, right sinus and back sinus all have inserted an anchor 3 at least, can reduce operating personnel and rotate, adjust the frequency of first support 1, can reduce the implantation degree of difficulty of valve device, can improve the success rate of aortic valve replacement, simultaneously, help shortening valve device implantation required time.

Alternatively, as shown in fig. 1-3, in one embodiment of the present application, one end of the anchor 3 is connected to the third sub-section 13, and the other end is remote from the third sub-section 13 and towards the second sub-section 12; the angle between the plane in which the anchor 3 lies and the radial plane of the second subsection 12 is acute.

In this embodiment, as shown in fig. 1, one end of the anchor 3 is connected with the third subsection 13, and the other end of the anchor 3 is 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 the direction of the ascending aorta pointing to the left ventricle outflow channel, other human tissues except the aortic sinus can not be influenced, and damage to other human tissues can be reduced.

Moreover, when the valve device is problematic and needs to be taken out from the human body, the aortic sinus can be gradually pulled out along the left ventricular outflow tract in the direction of the ascending aorta, the valve device can be conveniently recovered, and the damage to the 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 configuration, i.e. the free end is rounded, curved, etc. to avoid the free end of the anchor 3 stabbing the aortic sinus.

Optionally, as shown in fig. 1 and fig. 2, the included angle between the anchor 3 and the third subsection 13 is an acute angle, and after the valve device reaches the designated position through the cooperation of the anchor 3 and the third subsection 13, the V-shaped structure formed by the anchor 3 and the third subsection 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 shifting and falling off of the valve device can be reduced.

Alternatively, as shown in fig. 1, in one 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 the maximum radial dimension of each of the first sub-section 11 and the third sub-section 13 is larger than the radial dimension of the second sub-section 12.

In this embodiment, as shown in fig. 1, the first sub-section 11, the second sub-section 12 and the third sub-section 13, which are in a cylindrical shape in an expanded state, are coaxially arranged, and the maximum radial dimension of the first sub-section 11 is greater than the radial dimension of the second sub-section 12, and the maximum radial dimension of the third sub-section 13 is greater than the radial dimension of the second sub-section 12, so that the first support 1 in the expanded state is a dumbbell shape with a narrow middle 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 the diameter at the location of the primary aortic valve is significantly smaller than the diameter of the ascending aorta and the diameter of the outflow tract in the left ventricle due to the presence of the primary aortic valve. In this embodiment of the application, through setting up the biggest radial dimension of first subsection 11 and third subsection 13 all to be greater than the radial dimension of second subsection 12 to can increase the stiction of first subsection 11 and outflow tract inner wall, can increase the stiction of third subsection 13 and ascending aorta inner wall, and then can strengthen the fixed strength of first subsection 11 and outflow tract and the fixed strength of third subsection 13 and ascending aorta, can further strengthen the fixed strength of valve device, can reduce valve device's probability of coming off.

Alternatively, as shown in fig. 1, in one embodiment of the present application, the radial dimension of the first subsection 11 gradually decreases in the direction in which the first subsection 11 approaches the second subsection 12; the radial dimension of the third subsection 13 gradually decreases in a direction in which the plane in which the geometric center of the third subsection 13 is located points to the radial plane of the second subsection 12.

In this embodiment, as shown in fig. 1, the radial dimensions of the first subsection 11 and the third subsection 13 are all gradually changed. Optionally, along the direction that the first sub-section 11 approaches the second sub-section 12, the radial dimension of the first sub-section 11 gradually decreases 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 conical cylinder shape, so that smooth transition of a connecting portion between the first sub-section 11 and the second sub-section 12 can be ensured, and discomfort caused to the wall of the outflow channel by abrupt connection of the first sub-section 11 and the second sub-section 12 is avoided.

Optionally, along the direction that the plane of the geometric center of the third sub-segment 13 points to the radial plane of the second sub-segment 12, the radial dimension of the third sub-segment 13 gradually decreases until the radial dimension of the third sub-segment 11 is equal to the radial dimension of the second sub-segment 12, so that smooth transition of the connecting part between the second sub-segment 12 and the third sub-segment 13 can be ensured, and discomfort brought to the wall of the ascending aorta by the abrupt connection part between the second sub-segment 12 and the third sub-segment 13 is avoided.

Optionally, in one embodiment of the present application, the radial dimension of the third sub-section 13 gradually decreases along the direction in which the third sub-section 13 approaches the second sub-section 12 until the radial dimension of the third sub-section 13 is equal to the radial dimension of the second sub-section 12, i.e. the expanded form of the third sub-section 13 is the same as the expanded form of the first sub-section 11, and is also cone-shaped.

Optionally, as shown in fig. 1 and 2, in an embodiment of the present application, at least two connection portions 131 are disposed at the other end of the third sub-section 13 away from the second sub-section 12, and each connection portion 131 is uniformly arranged along the circumferential direction of the third sub-section 13.

In this embodiment, as shown in fig. 1 and fig. 2, the other end of the third subsection 13, which is far away from the second subsection 12, is provided with a connection portion 131, the connection portion 131 is used for being detachably connected with a delivery device, and in the delivery stage of the valve device, the delivery device can provide thrust for the connection portion 131, so that the valve device is separated from the delivery catheter of the delivery device, and after replacement of the valve device is completed, the delivery device is separated from the connection portion 131, so that the delivery device is conveniently withdrawn from the body.

Optionally, as shown in fig. 1 and fig. 2, the other end of the third subsection 13 far away from the second subsection 12 is provided with three connecting portions 131, and the three connecting portions 131 are uniformly distributed along the circumferential direction of the third subsection 13, so that the thrust provided by the conveying device can be ensured to uniformly act on the first bracket 1, the valve device is convenient to be smoothly separated from the conveying catheter, and the operation difficulty is reduced.

It should be noted that, a person skilled in the art may select the number of the connection portions 131 according to actual needs, and the valve device provided in the present application does not specifically limit the number of the connection portions 131.

Optionally, as shown in fig. 1, in an embodiment of the present application, the radial dimension of the third subsection 13 gradually decreases along the plane in which the geometric center of the third subsection 13 is located, and in a direction in which the other end of the third subsection 13 is located away from the plane in which the second subsection 12 is located.

In this embodiment, as shown in fig. 1 and fig. 2, along the direction that the plane in which the geometric center of the third sub-segment 13 is located points to the radial plane of the second sub-segment 12, the radial dimension of the third sub-segment 13 gradually decreases; the plane in which the geometric center of the third sub-section 13 is located points to the direction in which the other end of the third sub-section 13 is away from the plane in which the second sub-section 12 is located, and the radial dimension of the third sub-section 13 gradually decreases. I.e. the third subsection 13 in the unfolded state is in the shape of a drum with a wide middle and narrow ends.

In this embodiment, as shown in fig. 1, by setting the third subsection 13 with the shape shown in fig. 1, the contact probability between the connecting portion 131 and the wall of the ascending aorta can be reduced, the connecting portion 131 can be prevented from stimulating the wall of the ascending aorta, and discomfort of the connecting portion 131 to the wall of the ascending aorta is avoided.

Furthermore, during implantation of the valve device, the connection 131 can be prevented from irritating the wall of the ascending aorta during the operator's adjustment of the insertion of the anchor 3 into the aortic sinus. In the process of recovering the valve device, the connecting part 131 can be prevented from penetrating into the wall of the ascending aorta, so that the valve device can be recovered through the aorta, and the recovery difficulty of the valve device is reduced.

Alternatively, as shown in fig. 1, in one embodiment of the present application, one end of the connecting portion 131 is connected to the third sub-section 13, and the other end is remote from the third sub-section 13; the angle between the plane in which the connection 131 is located and the radial plane of the third subsection 13 is acute. Thereby can reduce the contact probability of connecting portion 131 and ascending aorta pipe wall, can avoid connecting portion 131 to amass the ascending aorta pipe wall, avoid connecting portion 131 to bring discomfort for the ascending aorta pipe wall, be convenient for valve device implantation and retrieve.

Optionally, as shown in fig. 1, the circumferential dimension of the other end of the connecting portion 131 along the third subsection 13 is greater than the circumferential dimension of the one end of the connecting portion 131 along the third subsection 13, so that the connecting portion 131 and the delivery device can be conveniently connected, optionally, the other end of the connecting portion 131 can be provided with a through hole, a guide wire is arranged in the through hole in a penetrating manner, and the guide wire can be directly pulled out of the through hole after the implantation of the valve device is completed.

Alternatively, as shown in fig. 1, in one embodiment of the present application, the first stent 1 comprises a shape memory material; the first sub-segment 11, the second sub-segment 12 and the third sub-segment 13 each comprise a plurality of connected grid cells; of the grid cells located at the end of the third subsection 13 near the second subsection 12, at least two grid cells are bent at the end near the second subsection 12 to form the anchor 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 implantation to enable the first stent 1 to be in a deployed state, thereby achieving the purpose of supporting a channel between an outflow tract and an ascending aorta. Alternatively, the shape memory material may comprise a shape memory alloy, a shape memory polymer, or the like.

Alternatively, as shown in fig. 1, each of the first subsection 11, the second subsection 12 and the third subsection 13 includes a plurality of connected grid cells, and in the unfolded state of the first stent 1, the plurality of connected grid cells are connected to form a tubular grid stent having a narrow middle and wide ends.

Alternatively, in the embodiment of the present application, the first stent 1 is a lattice stent formed by laser cutting a tubular object made of a material having shape memory characteristics, so that the first sub-segment 11, the second sub-segment 12, and the third sub-segment 13 are integrally formed.

Optionally, in one embodiment of the present application, the first subsection 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 occurrence of perivalvular leakage can be reduced by providing the first subsection 11 with a coating. Optionally, the coating is made of a polymer material or a biological tissue film.

Alternatively, 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 comprising any of the valve devices provided in the various embodiments described above and a delivery device for delivering the valve device.

In embodiments of the present application, during the delivery phase, the valve device is compressively mounted within the delivery device; after the delivery device reaches the designated position, the first sub-section 11, the second sub-section 12 and the third sub-section 13 of the first stent 1 in the valve device are sequentially separated from the delivery device, so that the first sub-section 11, the second sub-section 12 and the third sub-section 13 are in a cylindrical unfolding state, and the anchoring piece 3 arranged at one end, close to the second sub-section 12, of the third sub-section 13 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, pushing the first subsection 11 out of the delivery catheter, so that the first subsection 11 in a unfolded state can be attached to the inner peripheral wall of the left ventricular outflow tract; continuing to apply thrust to the valve device and pushing the second sub-section 12 out of the delivery catheter so that the second sub-section 12 in the deployed state can conform to the inner peripheral wall of the native aortic valve at the location; continuing to apply thrust to the valve device, the third sub-segment 13 is pushed out of the delivery catheter, so that the anchor 3 provided at the end of the third sub-segment 13 near the second sub-segment 12 is inserted into the specified target, i.e., so that the anchor 3 is inserted into the aortic sinus, and so that the third sub-segment 13 in the deployed state can be fitted to the inner peripheral wall of the ascending aorta.

Optionally, in one embodiment of the present application, the valve device further comprises a transmission member detachably connected to a connection 131 provided at an end of the third subsection 13 remote from the second subsection 12.

In this embodiment, the driving medium is detachably connected with the connecting portion 131, and can provide thrust to the connecting portion 131, and in the delivery stage, the driving medium is installed in the delivery catheter together with the valve device in a compression mode, and after the delivery device reaches the designated position, the first subsection 11, the second subsection 12 and the third subsection 13 are controlled to be separated from the delivery catheter in sequence through the driving medium.

Optionally, the driving member may also provide a pulling force to the connection 131 to enable the position of the anchor 3 relative to the aortic sinus to be adjusted by the driving member during the insertion of the anchor 3 into the aortic sinus, facilitating the insertion of the anchor 3 into the aortic sinus. Meanwhile, when the valve device needs to be recovered, the transmission part provides a pulling force for the connecting part 131, so that the valve device can be recovered directly through the aorta, and the recovery difficulty of the valve device is reduced.

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 the designated position, the first support 1 is in a unfolding state, the first cylindrical subsection 11 is attached to the inner wall of the outflow channel in the left ventricle, the third cylindrical subsection 13 is attached to the inner wall of the ascending aorta, the second subsection 12 of the annular artificial biological valve 2 is fixed at the position of the original ascending aortic valve, the anchoring piece 3 arranged at one end, close to the second subsection 12, of the third subsection 13 is inserted into the aortic sinus between the original valve and the inner wall of the aorta, and through arranging the anchoring pieces 3 uniformly along the circumferential direction of the third subsection 13, the probability that the anchoring pieces 3 are inserted into the aortic sinus can be increased, so that the fixing strength of the position of the valve device and the original ascending aortic valve can be improved, and the success rate of aortic valve replacement is further improved.

2. In the valve device provided by the embodiment of the application, through setting up first subsection 11, second subsection 12 and third subsection 13 coaxial setting, and the biggest radial dimension of first subsection 11 and third subsection 13 is all greater than the radial dimension of second subsection 12 to can increase the static friction of first subsection 11 and outflow tract inner wall, can increase the static friction of third subsection 13 and ascending aorta inner wall, and then can strengthen the fixed strength of first subsection 11 and outflow tract and the fixed strength of third subsection 13 and ascending aorta, can further strengthen the fixed strength of valve device, can reduce the probability that drops of valve device.

Those of skill in the art will appreciate that the various operations, methods, steps in the flow, actions, schemes, and alternatives discussed in the present application may be alternated, altered, combined, or eliminated. Further, other steps, means, or steps in a process having various operations, methods, or procedures discussed in this application may be alternated, altered, rearranged, split, combined, or eliminated. Further, steps, measures, schemes in the prior art with various operations, methods, flows disclosed in the present application may also be alternated, altered, 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", etc., are based on the exemplary directions or positional relationships shown in the drawings, are for convenience of description or simplifying the description of the embodiments of the present application, and do not indicate or imply that the apparatus or components referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present application.

The terms "first," "second," and the like, 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 defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present application, unless otherwise indicated, the meaning of "a plurality" is two or more.

In the description of the present application, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the terms in this application will be understood by those of ordinary skill in the art in a specific context.

In the description of the present specification, a particular feature, structure, material, or characteristic may be combined in any suitable manner in 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, for those skilled in the art, other similar implementation means based on the technical ideas of the present application are adopted without departing from the technical ideas of the solutions of the present application, and also belong to the protection scope of the embodiments of the present application.

Claims

1. A valve device, comprising: a first stent (1), an artificial 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 into a whole, the second subsection (12) is annularly arranged on the artificial biological valve (2), the first subsection (11), the second subsection (12) and the third subsection (13) are all cylindrical when the first support (1) is in an unfolding state, the cylindrical first subsection (11) is used for being attached to the inner wall of an outflow channel in a left ventricle, the cylindrical second subsection (12) is used for being fixed at an original ascending aortic valve, and the cylindrical third subsection (13) is used for being attached to the inner wall of an ascending aorta; the anchoring pieces (3) are arranged at one end, close to the second subsection (12), of the third subsection (13), the anchoring pieces (3) are uniformly distributed along the circumferential direction of the third subsection (13), and the anchoring pieces (3) are used for being inserted into an aortic sinus between the original ascending aortic valve and the inner wall of an aorta; one end of the anchor (3) is connected to the third subsection (13), and the other end is remote from the third subsection (13) and faces the second subsection (12); the other end of the anchoring piece (3) does not exceed the artificial biological valve (2); the included angle between the plane where the anchoring piece (3) is located and the radial plane of the second sub-section (12) is an acute angle, the anchoring piece (3) and the third sub-section (13) form a V-shaped structure, the first sub-section (11), the second sub-section (12) and the third sub-section (13) are coaxially arranged, 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), and the radial size of the first sub-section (11) is gradually reduced along the direction that the first sub-section (11) approaches the second sub-section (12); the radial dimension of the third sub-section (13) gradually decreases along the direction of the plane where the geometric center of the third sub-section (13) is located to the radial plane of the second sub-section (12), the radial dimension of the third sub-section (13) gradually decreases along the direction of the plane where the geometric center of the third sub-section (13) is located to the plane where the other end of the third sub-section (13) is away from the second sub-section (12), the radial dimension of the third sub-section (13) gradually decreases, the second sub-section in a cylindrical shape is located to the original ascending aortic valve, an anchoring piece is inserted into the aortic sinus between the original ascending aortic valve and the inner wall of the aortic valve, and the first sub-section, the second sub-section and the third sub-section in the first bracket are all provided with a covering film, and the covering film is molded by adopting high polymer materials or biological tissues.

2. Valve device according to claim 1, characterized in that the third sub-section (13) is circumferentially evenly arranged with at least six of the anchors (3).

3. Valve device according to claim 1, wherein the third sub-section (13) is provided with at least two connection portions (131) at its other end remote from the second sub-section (12), each connection portion (131) being evenly arranged along the circumference of the third sub-section (13).

4. Valve device according to claim 1, characterized in that the first stent (1) comprises a shape memory material; -the first sub-segment (11), the second sub-segment (12) and the third sub-segment (13) each comprise a plurality of connected grid cells; of the grid cells located at one end of the third subsection (13) close to the second subsection (12), at least two grid cells are bent to form an anchor (3) at one end of the third subsection (13) close to the second subsection (12).

5. A valve device system, comprising: the valve device of any one of claims 1-4 and a delivery device for delivering the valve device; during a delivery phase, the valve device is compressively mounted within the delivery device; after the conveying device reaches a designated position, a first subsection (11), a second subsection (12) and a third subsection (13) of the first bracket (1) in the valve device are sequentially separated from the conveying 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 piece (3) arranged on one end, close to the second subsection (12), of the third subsection (13) is inserted into a designated target.

6. Valve device system according to claim 5, further comprising a transmission member detachably connected to a connection (131) provided at an end of the third subsection (13) remote from the second subsection (12).