CN115607339B

CN115607339B - Valve device and valve device implantation system

Info

Publication number: CN115607339B
Application number: CN202211386983.8A
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: 2023-02-28
Anticipated expiration: 2042-11-07
Also published as: CN115607339A

Abstract

The embodiment of the application provides a valve device and a valve device implantation system. In the valve device that this application provided, through setting up the adjusting part who is connected with the second sub-support, after the valve device is carried to the assigned position in the human body, be in the minimum radial dimension that the expansion state is cylindric second sub-support through adjusting part regulation, the lateral wall of outflow tract in the second sub-support oppression left ventricle that can avoid being in the expansion state, thereby can avoid the outflow tract to narrow down, can avoid the outflow tract to appear and block the problem, and then can improve the success rate of valve replacement art.

Description

Valve device and valve device implantation system

Technical Field

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

Background

The heart valve refers to a valve between an atrium and a ventricle or between a ventricle and an artery, wherein a valve located between a left ventricle and a left atrium is called a mitral valve. In the case of a diseased mitral valve, the problem of mitral regurgitation is likely to arise, i.e., the mitral valve is difficult to close as the left ventricle contracts, causing regurgitation of blood from the left ventricle into the left atrium. Mitral regurgitation can be a serious threat to the patient's health.

Currently, the primary means of inhibiting mitral regurgitation involves replacing the native mitral valve with a prosthetic valve device. However, in the mitral valve replacement process, the left ventricular outflow tract is easy to be obstructed, so that the success rate of valve replacement is low.

Disclosure of Invention

The application provides a valve device and a valve device implantation system aiming at the defects of the prior art, and aims to solve the technical problem that the outflow tract is easy to have obstruction in the valve replacement process in the prior art.

In a first aspect, the present application provides a valve device comprising:

an artificial biological valve;

the first support comprises a first sub-support and a second sub-support, one end of the first sub-support is connected with one end of the second sub-support, the artificial biological valve is connected with the inner peripheral wall of the first sub-support, and the first sub-support in the unfolding state and the second sub-support in the unfolding state are both cylindrical;

and the adjusting assembly is connected with the other end, away from the first sub-bracket, of the second sub-bracket so as to adjust the minimum radial dimension of the second sub-bracket.

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

in the conveying stage, the transmission part is connected with the adjusting component of the valve device, and the valve device is compressed and installed in the conveying control device;

after the conveying control device reaches the designated position, the first sub-support and the second sub-support of the first support in the valve device are both in a cylindrical expansion state, and the transmission piece is used for driving the adjusting assembly so as to adjust the minimum radial size of the second sub-support.

The beneficial technological effect that technical scheme that this application provided brought includes:

in the valve device that this application provided, through setting up the adjusting part who is connected with the second sub-support, after the valve device is carried to the assigned position in the human body, be in the minimum radial dimension that the expansion state is cylindric second sub-support through adjusting part regulation, the lateral wall of outflow tract in the second sub-support oppression left ventricle that can avoid being in the expansion state, thereby can avoid the outflow tract to narrow down, can avoid the outflow tract to appear and block the problem, and then can improve the success rate of valve replacement art.

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 an exploded view of the first stent of the valve device of FIG. 1 according to an embodiment of the present disclosure;

FIG. 3 is a schematic view of the valve device of FIG. 1 in an initial state after implantation in a heart, according to an embodiment of the present disclosure;

FIG. 4 is a schematic view of the valve device of FIG. 1 after modulation after implantation in a heart, as provided by an embodiment of the present application;

FIG. 5 is a schematic view of an adjustment assembly of another valve device provided in accordance with an embodiment of the present disclosure;

FIG. 6 is a schematic view of a retainer of the adjustment assembly of FIG. 5 according to an exemplary embodiment of the present disclosure;

FIG. 7 is a schematic structural view of an adjustment member of the adjustment assembly of FIG. 5 according to an exemplary embodiment of the present disclosure;

FIG. 8 is a schematic view of an adjustment member of an adjustment assembly of another valve device provided in accordance with an embodiment of the present disclosure;

FIG. 9 is a cross-sectional view of a retainer of the adjustment assembly of the valve device of FIG. 1 provided by an embodiment of the present application;

FIG. 10 is a schematic view of an assembly of the clamping member and the clamping member of FIG. 9 in an uncompressed state with the adjustment member according to an embodiment of the present application;

FIG. 11 is a schematic view of the clamping member of FIG. 9 with the clamping body and the clamping member in a pressing state and the adjustment member assembled together according to an embodiment of the present application;

FIG. 12 is a schematic view of a second stent of the valve device of FIG. 1 according to an embodiment of the present disclosure;

FIG. 13 is a schematic view of a valve device implantation system according to an embodiment of the present disclosure;

fig. 14 is a schematic view of the assembly of the control device and the transmission member in the valve device implantation system of fig. 13, according to an embodiment of the present disclosure.

Description of the reference numerals:

1-artificial biological valve;

2-a first support;

21-a first sub-mount; 22-a second sub-mount; 221-an anchor; 2211-anchoring portion; 23-skirt part;

3-a regulating component;

31-a clip; 311-a chucking body; 3111-a first via; 312-a snap; 3121-a second through hole; 313-an elastic member;

32-an adjustment member; 321-a first portion; 322-a second portion; 3221-a third via;

4-a second scaffold;

5-a transmission member;

6-a conveying device; 61-a first handle; 62-a delivery catheter;

7-a control device; 71-a pushing tube; 72-a push rod; 73-a second handle; 74-a locking valve;

101-left atrium; 102-left ventricle; 1021-outflow tract; 103-aorta; 1031-aortic valve; 104-anterior valve; 105-posterior lobe.

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.

For the valve device for mitral valve replacement existing in the current market, in the mitral valve replacement process, the valve stent in the expanded state can press the outflow tract of the left ventricle, so that the outflow tract becomes narrow, even the outflow tract is obstructed, blood in the left ventricle is difficult to flow to the aorta through the outflow tract, the blood supply of the aorta is affected, the life health of a patient is further damaged, and the success rate of valve replacement is reduced.

If the size of the valve stent is reduced in order to reduce the degree that the valve stent presses the left ventricular outflow tract in the unfolded state, the anchoring force of the valve stent is reduced, the valve stent is easy to move and even fall off, and the success rate of valve replacement is further reduced.

The present application provides a valve device and a valve device implantation 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, the structural schematic diagram of the valve device is shown in fig. 1, the structural explosion schematic diagram of a first support in the valve device shown in fig. 1 is shown in fig. 2, the schematic diagram of the initial state of the valve device after being implanted into a heart is shown in fig. 3, and the schematic diagram of the valve device after being implanted into the heart after being adjusted is shown in fig. 4. The valve device comprises: an artificial bio-valve 1, a first stent 2 and an adjustment assembly 3.

In the embodiment of the application, the first stent 2 comprises a first sub-stent 21 and a second sub-stent 22, one end of the first sub-stent 21 is connected with one end of the second sub-stent 22, the artificial biological valve 1 is connected with the inner peripheral wall of the first sub-stent 21, and both the first sub-stent 21 in the expanded state and the second sub-stent 22 in the expanded state are cylindrical; and the adjusting component 3 is connected with the other end, far away from the first sub-bracket 21, of the second sub-bracket 22 so as to adjust the minimum radial dimension of the second sub-bracket 22.

In the valve device provided by the application, through setting up the adjusting part 3 that is connected with second sub-support 22, after the valve device is carried to the assigned position in the human body, adjust the minimum radial dimension that is cylindric second sub-support 22 in the state of expanding through adjusting part 3, the lateral wall of outflow channel 1021 in the second sub-support 22 that can avoid being in the state of expanding oppresses left ventricle 102 can be avoided to can avoid outflow channel 1021 to narrow, can avoid outflow channel 1021 to block the problem, and then can improve the success rate of valve replacement art.

In the embodiment of the present application, as shown in fig. 1 and 2, the first stent 2 includes a first sub-stent 21 and a second sub-stent 22 connected to each other, and both the first sub-stent 21 in the expanded state and the second sub-stent 22 in the expanded state are cylindrical, as shown in fig. 1 and 2, one end of the first sub-stent 21 is connected to one end of the second sub-stent 22, so that the cylindrical first sub-stent 21 and the cylindrical second sub-stent 22 are connected to form a cylindrical stent which is communicated with each other.

In the embodiment of the present application, as shown in fig. 1 and fig. 2, the artificial biologic valve 1 is connected to the first sub-stent 21 and is surrounded by the peripheral wall of the first sub-stent 21 in a cylindrical shape; the adjusting assembly 3 is connected to the other end of the second sub-mount 22, which is away from the first sub-mount 21, to adjust the minimum radial dimension of the second sub-mount 22.

In the present embodiment, the mitral valve replacement is taken as an example to illustrate the working principle of the valve device provided in the present embodiment. In order to facilitate a clear understanding of the working principle of the valve device provided in the embodiments of the present application, the following description will be made with reference to fig. 1 to 4.

As shown in fig. 3, after the valve device is implanted into the heart, the first stent 2 is located at the communication position between the left atrium 101 and the left ventricle 102, specifically, the first sub-stent 21 is located in the left atrium 101, and the second sub-stent 22 is located at the position of the native mitral valve, and is clamped and fixed by the anterior valve 104 of the native mitral valve and the posterior valve 105 of the native mitral valve, so that the bioprosthetic valve 1 can work in place of the native mitral valve.

As shown in fig. 3, since the native mitral valve is located close to the outflow tract 1021 of the left ventricle 102, the side wall of the outflow tract 1021 includes the anterior valve 104 of the native mitral valve, the minimum radial dimension of the second sub-stent 22 in the expanded state is D1, the outflow tract 1021 narrows because the second sub-stent 22 in the expanded state presses against the anterior valve 104 of the native mitral valve, and thus the amount of blood flowing from the left ventricle 102 to the aorta 103 is reduced, and the pressing of the second sub-stent 22 may affect the operation of the aortic valve 1031 located between the aorta 103 and the outflow tract 1021, further affect the blood flowing from the left ventricle 102 to the aorta 103, and thus may cause obstruction of the outflow tract 1021.

As shown in fig. 4, the minimum radial dimension of the second sub-stent 22 can be adjusted by the adjusting component 3, the minimum radial dimension of the end of the second sub-stent 22 away from the first sub-stent 21 can be reduced, the minimum radial dimension of the second sub-stent 22 in the expanded state is D2, and as can be seen from a comparison between fig. 3 and fig. 4, the minimum radial dimension of the second sub-stent 22 is significantly reduced, so that the second sub-stent 22 in the expanded state can be prevented from excessively pressing the anterior valve 104 of the native mitral valve, that is, the degree of the second sub-stent 22 pressing the side wall of the outflow tract 1021 in the left ventricle 102 can be reduced, the side wall of the outflow tract 1021 can be prevented from being significantly deformed, the outflow tract 1021 can be prevented from being narrowed, and the outflow tract 1021 can be prevented from being obstructed.

Moreover, in the embodiment of the present application, since the adjusting component 3 adjusts the minimum radial dimension of the second sub-stent 22 in the cylindrical shape in the expanded state, during the delivery of the valve device into the body, it is not necessary to judge the relative angle between the outflow tract 1021 and the valve device in advance, when the second sub-stent 22 is to be extruded to the side wall of the outflow tract 1021, the second sub-stent 22 can be prevented from extruding the side wall of the outflow tract 1021 by the adjustment of the adjusting component 3, the difficulty of the implantation of the valve device can be reduced, the implantation speed of the valve device can be increased, and the time required for valve replacement can be shortened.

Further, after the valve device is implanted into the preset position of the human body, the first stent 2 is in the expanded state, that is, in the process of adjusting the minimum radial dimension of the second sub-stent 22, the first stent 2 is also in the expanded state, so that the anchoring elements arranged on the outer peripheral wall of the second sub-stent 22 and the anchoring elements of the valve leaflets, the chordae tendinae and other cardiac tissues are not affected, the fixation of the first stent 2 and the heart is not affected, the difficulty of the valve device implantation can be further reduced, the implantation speed of the valve device can be increased, and the time required for valve replacement can be shortened.

Optionally, in this embodiment of the application, the artificial biologic valve 1 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. Alternatively, in the present embodiment, the bioprosthetic valve 1 may include three separate valves, each of which is connected to the inner circumferential wall of the first sub-stent 21 in the first stent 2. Optionally, the bioprosthetic valve 1 may further include an integrally formed valve structure, a peripheral wall of the valve structure is connected with an inner peripheral wall of the first sub-stent 21, and three valve leaflets which can be closed and opened are included in the middle of the valve structure.

Optionally, in this embodiment of the application, the bioprosthetic valve 1 may be sutured to the first sub-holder 21 by a suture, so that the bioprosthetic valve 1 is fixedly connected to the first sub-holder 21, the connection strength between the bioprosthetic valve 1 and the first sub-holder 21 is ensured, and the service life of the valve device is ensured.

Alternatively, as shown in fig. 5-7, in one embodiment of the present application, the adjustment assembly 3 comprises a clamping member 31 and at least two adjustment members 32; the chucking member 31 includes a chucking body 311, and at least two first through holes 3111 are provided in the chucking body 311; the first part 321 of the adjusting part 32 is connected with the other end of the second sub-bracket 22, and the second part 322 passes through the first through hole 3111; the adjusting member 32 is used to drive the connection point of the second sub-mount 22 and the first portion 321 to be close to the center of the radial plane of the second sub-mount 22 under the action of the external force.

In the embodiment of the present application, as shown in fig. 5, a schematic structural diagram of an adjustment assembly 3 provided in the embodiment of the present application is provided, and in order to clearly show how the adjustment assembly 3 is connected to a transmission member 5 of a valve device implantation system mentioned later, the transmission member 5 is shown in fig. 5.

In the present embodiment, the adjustment assembly 3 comprises at least two adjustment members 32 of the gripping member 31, and optionally, as shown in fig. 5, one gripping member 31 is provided with four adjustment members 32.

As shown in fig. 6, the chucking member 31 includes a chucking body 311, at least two first through holes 3111 are provided in the chucking body 311, and optionally, four first through holes 3111 are provided in the chucking body 311.

As shown in fig. 7, the adjusting member 32 includes a first portion 321 and a second portion 322 that are integrally formed, as can be seen from fig. 1 and 5, the first portion 321 is connected to the other end of the second subframe 22 away from the first subframe 21, the second portion 322 is used for penetrating the first through hole 3111, and a portion of the second portion 322 is penetrated in the first through hole 3111, when an external force is applied to the second portion 322, the second portion 322 drives the first portion 321 to move toward the first through hole 3111, and the first portion 321 drives the connection portion of the second subframe 22 and the first portion 321 to be close to the center of the radial plane of the second subframe 22, so as to adjust the minimum radial dimension of the second subframe 22, and prevent the second subframe 22 in the expanded state from pressing the sidewall of the outflow channel 1021, thereby avoiding the problem of obstruction of the outflow channel 1021.

Alternatively, as shown in fig. 1, 5 and 6, in one embodiment of the present application, the clamping member 31 is arranged coaxially with the second sub-mount 22, and the radial dimension of the clamping body 311 is smaller than the minimum radial dimension of the second sub-mount 22.

In the embodiment of the present application, as shown in fig. 1, the clamping member 31 is coaxially disposed with the second sub-mount 22, so that in the process of adjusting the minimum radial dimension of the second sub-mount 22, it can be ensured as much as possible that the displacement distance of the joint of each second sub-mount 22 and the first portion 321, which is close to the center of the radial plane of the second sub-mount 22, is consistent, and the accuracy of adjusting and controlling the minimum radial dimension of the second sub-mount 22 is improved.

Optionally, in the embodiment of the present application, as shown in fig. 1 and fig. 6, the radial dimension of the chucking body 311 is smaller than the minimum radial dimension of the second sub-mount 22, and during the process of adjusting the minimum radial dimension of the second sub-mount 22, it can be ensured that the connection point of each second sub-mount 22 and the first portion 321 is close to the center of the radial plane of the second sub-mount 22.

Alternatively, as shown in fig. 7 and 8, in one embodiment of the present application, the included angle between the first portion 321 and the second portion 322 is an obtuse angle; the second portion 322 is interference fit with the first through-hole 3111.

In the embodiment of the present application, the adjusting member 32 has a certain rigidity and elasticity, such as a memory alloy wire, so that the included angle between the first portion 321 and the second portion 322 can be kept stable. As shown in fig. 7, an included angle between the first portion 321 and the second portion 322 is an obtuse angle, so that in a sliding process of the second portion 322 along the first through hole 3111 under the action of an external force, the first portion 321 can be prevented from sliding into the first through hole 3111, a limiting effect can be achieved, and the problems that the second sub-bracket 22 is damaged, the first bracket 2 is displaced and the like due to an excessive force transmitted from the first portion 321 to the second sub-bracket 22 under the condition of an excessive external force can be prevented.

In the embodiment of the present application, the second portion 322 is in interference fit with the first through hole 3111, so that the static friction force between the second portion 322 and the peripheral wall of the first through hole 3111 is greater than the restoring force at the connection between the second sub-bracket 22 and the first portion 321, so that after the minimum radial dimension of the second sub-bracket 22 is adjusted to meet the requirement by applying an external force to the adjusting element 32, the adjusted minimum radial dimension of the second sub-bracket 22 can be maintained after the external force is removed, and the second sub-bracket 22 can be prevented from pressing the side wall of the outflow duct 1021 after the external force is removed.

Optionally, as shown in fig. 7, the adjusting element 32 is formed by a strip of alloy wire with memory, and a part of the alloy wire is bent to form one end of the first portion 321 for connecting with the second sub-stent 22, as shown in fig. 7, the end of the first portion 321 connected with the second sub-stent 22 is in a rounded triangle shape, and one side of the rounded triangle is connected with the second sub-stent 22, so that the contact area between the first portion 321 and the second sub-stent 22 can be increased, the number of the adjusting elements 32 in the adjusting assembly 3 can be reduced, the structure of the valve device can be simplified, the occupied volume of the valve device can be reduced, and the application scenario of the valve device can be expanded.

As shown in fig. 7, another portion of the alloy wire is bent to form a third through hole 3221 at an end of the second portion 322 away from the first portion 321, and the transmission member 5 is inserted through the through hole to facilitate the withdrawal of the transmission member 5 after the valve device is implanted to the set position.

Alternatively, as shown in fig. 8, the adjusting member 32 is also formed by a memory alloy wire, except that the length of the memory alloy wire is greater than that of the memory alloy wire shown in fig. 7, so that the radial dimensions of the first portion 321 and the second portion 322 formed by bending can be ensured, and the structural strength of the adjusting member 32 can be ensured.

It should be noted that, as shown in fig. 7 and 8, in order to facilitate clear illustration of the structure of the regulating member 32, a boundary line between the first part 321 and the second part 322 is indicated by a dotted line, and in an actual product, the first part 321 and the second part 322 are integrally formed and the dotted line does not exist.

Alternatively, as shown in fig. 1, 5 and 6, in an embodiment of the present application, the first through holes 3111 are uniformly arranged along the circumferential direction of the chucking body 311; the first portions 321 are uniformly arranged in the circumferential direction of the second sub-stent 22.

In the embodiment of the present application, as can be seen from fig. 5 and 6, the first through holes 3111 are uniformly arranged along the circumferential direction of the chuck body 311, that is, the first through holes 3111 are uniformly arranged along the circumferential direction of the same reference circle of the radial plane in the shape of the chuck body 311, and as can be seen from fig. 1 and 5, the first portions 321 are uniformly arranged along the circumferential direction of the second sub-mount 22, so that the adjustment and control accuracy of the minimum radial dimension of the second sub-mount 22 can be improved.

Alternatively, as shown in fig. 1, 5 and 6, the first through holes 3111 and the adjusting pieces 32 are both arranged in pairs, and two of the first through holes 3111 arranged in pairs are symmetrically arranged with respect to the axis of the chuck body 311, and two of the adjusting pieces 32 arranged in pairs are symmetrically arranged with respect to the axial direction of the second sub-mount 22, so that the adjustment control accuracy of the minimum radial dimension of the second sub-mount 22 can be further improved.

Alternatively, as shown in fig. 9, 10 and 11, in one embodiment of the present application, the adjustment assembly 3 comprises a gripping member 31 and at least two adjustment members 32; the chucking member 31 includes a chucking body 311 and a chucking member 312; the chucking body 311 is provided with at least two first through holes 3111, and the engaging member 312 is provided with at least two second through holes 3121; the adjusting part 32 is a flexible part, one part of the adjusting part 32 is connected with the other end of the second sub-bracket 22, the other part of the adjusting part is arranged in the first through hole 3111 and the second through hole 3121 in a penetrating way, and one side wall of the second through hole 3121 clamps the other part of the adjusting part 32 in the first through hole 3111; the adjusting member 32 is used to drive the connection of the second sub-mount 22 and a portion of the adjusting member 32 to be close to the center of the radial plane of the second sub-mount 22 under the action of an external force.

In the embodiment of the present application, as shown in fig. 9 to 11, the fastening member 31 includes a fastening body 311 and a fastening member 312, the fastening body 311 is provided with at least two first through holes 3111, the fastening member 312 is provided with at least two second through holes 3121, and optionally, the fastening member 312 includes a groove, and at least a portion of the fastening body 311 is located in the groove of the fastening member 312. The first through hole 3111 and the second through hole 3121 are disposed in a staggered manner, so that the sidewall of the second through hole 3121 can be inserted into the first through hole 3111.

In the embodiment of the present application, the adjusting element 32 is a flexible element, optionally, the adjusting element 32 is an alloy rope woven from alloy wires, one part of the adjusting element 32 is connected to the other end of the second sub-frame 22, as shown in fig. 10 and 11, another part of the adjusting element 32 is inserted into the first through hole 3111 and the second through hole 3121, when the adjusting element 32 is not subjected to an external force, one side wall of the second through hole 3121 engages another part of the adjusting element 32 in the first through hole 3111, and when the external force applied to the adjusting element 32 is greater than the engaging force between the engaging body 311 and the engaging member 312, part of the adjusting element 32 slides along the first through hole 3111 and the second through hole 3121, so as to drive the connection part of the second sub-frame 22 and the adjusting element 32 to be close to the center of the radial plane of the second sub-frame 22, thereby adjusting the minimum radial dimension of the second sub-frame 22, and preventing the second sub-frame 22 in the unfolded state from pressing the side wall of the outflow tract 1021, thereby avoiding the obstruction of the outflow tract 1021.

Alternatively, when the external force applied to the adjusting member 32 is removed, such that a side wall of the second through hole 3121 catches another portion of the adjusting member 32 in the first through hole 3111, the adjusted minimum radial dimension of the second sub-mount 22 can be maintained, and the second sub-mount 22 can be prevented from pressing the side wall of the outflow conduit 1021 after the external force is removed.

Optionally, as shown in fig. 9 and 10, in one embodiment of the present application, the retainer 31 further comprises an elastic member 313; one end of the elastic element 313 is connected to the locking body 311, and the other end is connected to the engaging element 312, so as to drive a sidewall of the second through hole 3121 to be inserted into the first through hole 3111.

In the embodiment of the present application, as shown in fig. 9 and 10, one end of the elastic element 313 is connected to the locking body 311, and the other end is connected to the engaging element 312, and when the elastic element 313 is not subjected to an external force, the elastic element 313 drives the locking body 311 to approach the engaging element 312, so that a sidewall of the second through hole 3121 is inserted into the first through hole 3111.

Optionally, the elastic member 313 is a spring.

Alternatively, as shown in fig. 1, 5 and 6, in one embodiment of the present application, the chucking body 311 has a ring shape, and an inner circumferential wall of the chucking body 311 having the ring shape is provided with a screw structure.

In the embodiment of the present application, as shown in fig. 6, the clamping body 311 is annular, and the inner peripheral wall of the clamping body 311 is provided with a thread structure, so that the clamping body 311 can be detachably connected to a control device of the valve device implantation system, which will be described later and will not be described herein again.

Optionally, in one embodiment of the present application, the valve device further comprises at least one of: the peripheral wall of the second sub-bracket 22 is provided with at least one anchoring piece 221, one side of the anchoring piece 221, which is far away from the second sub-bracket 22, is provided with at least one anchoring portion 2211, the free end of the anchoring portion 2211 is far away from the second sub-bracket 22, and the included angle between the plane of the free end of the anchoring portion 2211 and the plane of the second sub-bracket 22 is an acute angle; a skirt part 23 is arranged at the joint of the first sub-bracket 21 and the second sub-bracket 22; the first bracket 2 comprises a shape memory material, the first bracket 2 comprises a plurality of connected grid cells, and the plurality of connected grid cells are connected to form a cylindrical grid bracket when the first bracket 2 is in an unfolded state; the artificial biological valve 1 is connected with the inner peripheral wall of the second bracket 4, and the outer peripheral wall of the second bracket 4 is connected with the inner peripheral wall of the first bracket 2.

In the embodiment of the present application, as shown in fig. 1 and 2, the outer peripheral wall of the second sub-mount 22 is provided with at least one anchor 221. The specific number of the anchoring elements 221 arranged on the second sub-bracket 22 can be selected by those skilled in the art according to actual requirements, and the number of the anchoring elements 221 is not limited in any way. Alternatively, as shown in fig. 1, the anchoring elements 221 are uniformly arranged along the circumferential direction of the second sub-stent 22.

Optionally, as shown in fig. 1 and 2, one end of the anchor 221 is of a V-like structure, so that the anchor 221 can hook the leaflets (i.e., the anterior valve 104 and the posterior valve 105), chordae tendinae, etc. of the native mitral valve, which can enhance the strength of the valve device for fixing to the heart and reduce the chance of the valve device shifting and falling off.

Optionally, as shown in fig. 1 and fig. 2, a side of the anchor 221 away from the second sub-bracket 22 is provided with at least one anchor portion 2211, a free end of the anchor portion 2211 is away from the second sub-bracket 22, and an included angle between a plane of the free end of the anchor portion 2211 and a plane of the second sub-bracket 22 is an acute angle. After the valve device is implanted into the heart, the anchors 2211 are used to assist in clamping portions of the heart tissue, such as the valve leaflets, so that the strength of the valve device fixed to the heart can be enhanced, and the probability of displacement and falling off of the valve device can be reduced.

Alternatively, as shown in fig. 1, in a direction from one end of the anchor portion 2211 to the other end, an included angle between a plane of the other end of the anchor portion 2211 and a plane of the second sub-mount 22 gradually changes. Alternatively, all of the anchor portions 2211 provided to the same anchor 221 have the same angle with the anchor 221.

In the embodiment of the present application, as shown in fig. 1 to 4, a skirt portion 23 is provided at the junction of the first sub-bracket 21 and the second sub-bracket 22. Optionally, as shown in fig. 1 and fig. 2, the skirt portion 23 is disposed around the periphery of the joint of the first sub-stent 21 and the second sub-stent 22, and the free end of the skirt portion 23 extends in a direction away from the second sub-stent 22, so that the skirt portion 23 abuts against the inner wall of the left atrium 101, thereby facilitating the fixation of the first stent 2 to the left atrium 101, and reducing the occurrence of a valve leakage phenomenon. Optionally, the skirt portion 23 comprises a plurality of grid cells.

In the present embodiment, the first stent 2 comprises a shape memory material so that the first stent 2 can self-expand after implantation to place the first stent 2 in a deployed state. Alternatively, the shape memory material may include a shape memory alloy, a shape memory polymer, or the like.

Alternatively, as shown in fig. 1 and 2, the first stent 2 includes a plurality of connected lattice cells, and the plurality of connected lattice cells are connected to form a lattice stent in a cylindrical shape in an expanded state of the first stent 2.

Optionally, the first stent 2 is a mesh stent formed by weaving metal wires with shape memory characteristics, and is softer than a mesh stent formed by laser cutting, so that when the first stent 2 effectively supports the position of the native mitral valve, stimulation of the first stent 2 on cardiac tissue due to expansion can be reduced, and discomfort of a patient caused by the first stent 2 can be avoided. Meanwhile, the first support 2 can be compressed conveniently, so that the valve device can be compressed into a smaller conveying device, and the valve device is prevented from being incapable of being extruded and installed on the conveying device due to overlarge size.

In the embodiment of the present application, as shown in fig. 1 and 12, the valve device further includes a second stent 4, the bioprosthetic valve 1 is connected to an inner circumferential wall of the second stent 4, optionally, the bioprosthetic valve 1 and the second stent 4 are fixed by suture lines, and an outer circumferential wall of the second stent 4 is connected to an inner circumferential wall of the first stent 2. Through setting up in artificial biological valve 1 lug connection's second support 4, can avoid sewing up the influence of artificial biological valve 1 to first support 2 to can improve the production efficiency of valve device.

Optionally, the second stent 4 comprises a shape memory material to enable the second stent 4 to self-expand after implantation to place the second stent 4 in a deployed state. Alternatively, as shown in fig. 1, the second stent 4 also comprises a plurality of connected grid cells, and in particular, the second stent 4 is a grid stent formed by laser cutting a material with shape memory property.

Optionally, in one embodiment of the present application, the first stent 2 and the second stent 4 are each provided with a covering membrane to reduce the occurrence of paravalvular leakage.

Based on the same inventive concept, embodiments of the present application provide a valve device implantation system, which is schematically illustrated in fig. 13, and includes: a transmission member 5, a delivery control device and any valve device provided in the above embodiments.

In the embodiment of the application, the transmission member 5 is connected with the adjusting component 3 of the valve device during the delivery stage, and the valve device is compressed and installed in the delivery control device. After the delivery control device reaches the designated position, the first sub-stent 21 and the second sub-stent 22 of the first stent 2 in the valve device are in a cylindrical expansion state, and the transmission member 5 is used for driving the adjusting assembly 3 to adjust the minimum radial dimension of the second sub-stent 22.

In the embodiment of the present application, after the delivery control device reaches the designated position, the first stent 2 is detached from the delivery control device, so that the first sub-stent 21 and the second sub-stent 22 of the first stent 2 are both in a cylindrical expanded state, so that the first sub-stent 21 is located in the left atrium 101, the second sub-stent 22 is located at the position of the native mitral valve and is clamped and fixed by the anterior valve 104 of the native mitral valve and the posterior valve 105 of the native mitral valve, and in the process of fixing the first stent 2 to the heart, the transmission component 5 is used for driving the adjusting component 3 to adjust the minimum radial dimension of the second sub-stent 22, so as to prevent the second sub-stent 22 in the expanded state from pressing the side wall of the outflow channel 1021 in the left ventricle 102, thereby preventing the outflow channel 1021 from narrowing, and avoiding the outflow channel 1021 from blocking.

After the first stent 2 is fixed to the heart, the transmission member 5 is withdrawn from the patient. Optionally, in the embodiment of the present application, the transmission member 5 comprises a wire, a portion of which is detachably connected to the adjustment assembly 3, and the operator controls another portion of the wire, thereby enabling the operator to control the adjustment assembly 3.

Alternatively, as shown in fig. 13, in one embodiment of the present application, the conveyance control means includes the conveyance means 6 and the control means 7; the delivery device 6 is used for delivering the valve device in a compressed state to a designated position; a part of the transmission piece 5 penetrates through a hole which is arranged at one end of the adjusting piece 32 far away from the second sub-bracket 22 in the adjusting component 3, and two ends of the transmission piece 5 are connected with the control device 7; the control device 7 is used for moving the adjusting assembly 3 via the transmission member 5 and for pushing the valve device out of the delivery device 6.

In the embodiment of the present application, the delivery device 6 is used for delivering the valve device in the compressed state to the designated position, the control device 7 is matched with the delivery device 6, and when the delivery device 6 delivers the valve device in the compressed state to the designated position, the control device 7 pushes the valve device out of the delivery device 6.

In the embodiment of the present application, as shown in fig. 1, fig. 5, fig. 12 and fig. 13, a part of the transmission member 5 penetrates through a third through hole 3221 arranged at one end of the adjusting member 32 far away from the second sub-bracket 22 in the adjusting assembly 3, and two ends of the transmission member 5 are connected with the control device 7, so that the movement of the transmission member 5 can be controlled by the control device 7, and the transmission member 5 drives the adjusting assembly 3 to move, so as to adjust the minimum radial dimension of the second sub-bracket 22.

Alternatively, as shown in fig. 13, in one embodiment of the present application, the delivery device 6 comprises a first handle 61 and a delivery catheter 62, the valve device is compressed and mounted in the delivery catheter 62 during the delivery stage, and the first handle 61 is sleeved on a part of the delivery catheter 62.

In the embodiment of the present application, as shown in fig. 13, the delivery device 6 includes a delivery catheter 62 and a first handle 61, the delivery catheter 62 is used for installing the compressed valve device, the first handle 61 is sleeved on a portion of the delivery catheter 62, and in the delivery stage, the operator holds the first handle 61, thereby facilitating the operation of the operator.

Alternatively, as shown in fig. 13 and 14, in one embodiment of the present application, the control device 7 comprises a push pipe 71, a push rod 72, a second handle 73 and a lock valve 74; part of the pushing pipe 71 is sleeved in the conveying device 6; a part of the pushing rod 72 is sleeved in the pushing pipe 71, and one end of the part of the pushing rod 72 is screwed with the clamping body 311 of the clamping member 31 in the adjusting assembly 3; the second handle 73 is sleeved on part of the push pipe 71; one end of the second handle 73 is provided with a locking valve 74, and both ends of the transmission member 5 are connected to one locking valve 74.

In the embodiment of the present application, as shown in fig. 13 and 14, the control device 7 includes a push pipe 71, a push rod 72, a second handle 73, and a lock valve 74.

Optionally, a portion of the pushing tube 71 is inserted through the conveying conduit 62 and the first handle 61 of the conveying device 6, the pushing tube 71 provides a passage for the movement of the pushing rod 72, a portion of the pushing rod 72 is sleeved in the pushing tube 71, and one end of the portion of the pushing rod 72 is screwed with the thread structure of the clamping body 311 of the clamping member 31 in the adjusting assembly 3. The other end of the push rod 72 is disposed at one end of the second handle 73 away from the delivery device 6, and after the delivery device 6 delivers the valve device in the compressed state to a specified position, the operator can release the screw connection between the push rod 72 and the retainer 31 by rotating the other end of the push rod 72.

Alternatively, as shown in fig. 13 and 14, one end of the second handle 73 is provided with a locking valve 74, a part of the transmission member 5 is inserted into a hole of the adjusting member 32, the second portion 322 of which is far away from the first portion 321, both ends of the transmission member 5 are connected to one locking valve 74, and an operator can move the adjusting assembly 3 driven by the transmission member 5 by pulling one end of the transmission member 5, so as to adjust the minimum radial dimension of the second sub-bracket 22.

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

in the valve device that this application provided, through setting up the adjusting part 3 of being connected with second sub-support 22, after the valve device is carried to the assigned position in the human body, be in the minimum radial dimension that the cylindrical second sub-support 22 is to be of expansion state through adjusting part 3 regulation, the lateral wall that can avoid being in the second sub-support 22 of expansion state oppression outflow 1021 in the left ventricle 102, thereby can avoid outflow 1021 to narrow, can avoid outflow 1021 to block the problem, and then can improve the success rate of valve replacement art.

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, various operations, methods, steps, measures, schemes in the various processes, methods, procedures that have been discussed in this application may be alternated, modified, rearranged, decomposed, combined, or eliminated. Further, steps, measures, schemes in the prior art having various operations, methods, procedures disclosed in the present application may 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 simplicity of describing the embodiments of the present application 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 therefore, 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 to implicitly indicate 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, "a plurality" means 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:

an artificial biological valve (1);

the first stent (2) comprises a first sub-stent (21) and a second sub-stent (22), one end of the first sub-stent (21) is connected with one end of the second sub-stent (22), the artificial biological valve (1) is connected with the inner peripheral wall of the first sub-stent (21), and the first sub-stent (21) in a spreading state and the second sub-stent (22) in the spreading state are both cylindrical;

and the adjusting assembly (3) is connected with the other end, far away from the first sub-bracket (21), of the second sub-bracket (22) so as to adjust the minimum radial dimension of the second sub-bracket (22).

2. The valve device according to claim 1, characterized in that said adjustment assembly (3) comprises a gripping member (31) and at least two adjustment members (32);

the clamping piece (31) comprises a clamping body (311), and at least two first through holes (3111) are formed in the clamping body (311);

the first part (321) of the adjusting piece (32) is connected with the other end of the second sub-bracket (22), and the second part (322) penetrates through the first through hole (3111); the adjusting piece (32) is used for driving the joint of the second sub-bracket (22) and the first part (321) to be close to the center of a radial plane of the second sub-bracket (22) under the action of external force.

3. The valve device according to claim 2, characterized in that said gripping member (31) is arranged coaxially to said second sub-stent (22), said gripping body (311) having a radial dimension smaller than the minimum radial dimension of said second sub-stent (22).

4. The valve device of claim 2, wherein the angle between the first portion (321) and the second portion (322) is an obtuse angle;

the second portion (322) is in interference fit with the first through-hole (3111).

5. The valve device according to claim 2, wherein each of the first through holes (3111) is uniformly arranged along a circumferential direction of the chucking body (311);

the first parts (321) are uniformly arranged along the circumferential direction of the second sub-bracket (22).

6. The valve device according to claim 1, characterized in that the adjustment assembly (3) comprises a clamping member (31) and at least two adjustment members (32);

the clamping piece (31) comprises a clamping body (311) and a clamping piece (312); the clamping body (311) is provided with at least two first through holes (3111), and the clamping piece (312) is provided with at least two second through holes (3121);

the adjusting piece (32) is a flexible piece, one part of the adjusting piece is connected with the other end of the second sub-bracket (22), the other part of the adjusting piece penetrates through the first through hole (3111) and the second through hole (3121), and one side wall of the second through hole (3121) clamps the other part of the adjusting piece in the first through hole (3111); the adjusting piece (32) is used for driving a connection part of the second sub-bracket (22) and a part of the adjusting piece to be close to the center of a radial plane of the second sub-bracket (22) under the action of external force.

7. The valve device according to claim 6, wherein said retainer (31) further comprises an elastic member (313);

one end of the elastic piece (313) is connected with the clamping body (311), and the other end of the elastic piece is connected with the clamping piece (312) so as to drive one side wall of the second through hole (3121) to be inserted into the first through hole (3111).

8. The valve device according to any of claims 2 to 7, wherein the check body (311) is annular, and an inner circumferential wall of the annular check body (311) is provided with a thread structure.

9. The valve device of claim 1, further comprising at least one of:

the peripheral wall of the second sub-bracket (22) is provided with at least one anchoring piece (221); at least one anchoring part (2211) is arranged on one side of the anchoring part (221) far away from the second sub-bracket (22), the free end of the anchoring part (2211) is far away from the second sub-bracket (22), and the included angle between the plane where the free end of the anchoring part (2211) is located and the plane where the second sub-bracket (22) is located is an acute angle;

a skirt part (23) is arranged at the joint of the first sub-bracket (21) and the second sub-bracket (22);

the first support (2) comprises a shape memory material; the first support (2) comprises a plurality of connected grid units, and the plurality of connected grid units are connected to form a cylindrical grid support when the first support (2) is in an unfolded state;

the artificial biological valve (1) is connected with the inner peripheral wall of the second support (4), and the outer peripheral wall of the second support (4) is connected with the inner peripheral wall of the first support (2).

10. A valve device implantation system, comprising: a transmission (5), a delivery control device and a valve device according to any one of claims 1 to 9;

in the delivery phase, the transmission member (5) is connected with an adjusting component (3) of the valve device, and the valve device is compressed and installed in the delivery control device;

after the conveying control device reaches a designated position, a first sub-bracket (21) and a second sub-bracket (22) of a first bracket (2) in the valve device are in a cylindrical unfolding state, and the transmission piece (5) is used for driving the adjusting assembly (3) so as to adjust the minimum radial size of the second sub-bracket (22).

11. The valve device implantation system according to claim 10, wherein the delivery control device includes a delivery device (6) and a control device (7);

the delivery device (6) is used for delivering the valve device in a compressed state to a specified position;

a part of the transmission piece (5) penetrates through a hole which is formed in the adjusting component (3) and is formed in one end, far away from the second sub-bracket (22), of the adjusting piece (32), and two ends of the transmission piece (5) are connected with the control device (7); the control device (7) is used for driving the adjusting component (3) to move through a transmission piece (5) and pushing the valve device out of the conveying device (6).

12. The valve device implantation system according to claim 11, wherein the delivery device (6) comprises a first handle (61) and a delivery catheter (62) and a first handle (61), the valve device being compressively mounted within the delivery catheter (62) during a delivery stage, the first handle (61) sheathing a portion of the delivery catheter (62).

13. The valve device implantation system of claim 11, wherein the control device (7) comprises a push tube (71), a push rod (72), a second handle (73), and a lock valve (74);

part of the pushing pipe (71) is sleeved in the conveying device (6); part of the pushing rod (72) is sleeved in the pushing pipe (71), and one end of the pushing rod (72) is in threaded connection with a clamping body (311) of a clamping piece (31) in the adjusting assembly (3); the second handle (73) is sleeved on part of the pushing pipe (71); one end of the second handle (73) is provided with the locking valve (74), and two ends of the transmission piece (5) are connected to one locking valve (74).