WO2023133723A1

WO2023133723A1 - Interventional mitral valve stent having two side claws, and interventional mitral valve

Info

Publication number: WO2023133723A1
Application number: PCT/CN2022/071562
Authority: WO
Inventors: 钟生平; 靳永富; 孟春旺
Original assignee: 金仕生物科技（常熟）有限公司
Priority date: 2022-01-12
Filing date: 2022-01-12
Publication date: 2023-07-20

Abstract

An interventional mitral valve stent having two side claws, and an interventional mitral valve, wherein, the stent comprises a body (100), a limiting part (110) is formed at one end of the body (100), the other end of the body (100) is provided with two introduction claws (200), a projection of the body (100) in the implantation direction is oval or D-shaped, and the introduction claws (200) are arranged at two ends of the body (100) in a long-axis direction. By providing the two introduction claws (200) at two ends of the long axis of the stent, pulling the introduction claws (200) allows for adjusting the height of two ends of the limiting part (110) in the long-axis direction, thus ensuring that the limiting part (110) is reliably attached to the inner wall of the atrium (300), allowing the interventional valve to replace the operation of the native valve during the adjustment period, thus avoiding the problem of restricted or obstructed blood flow during the adjustment period and providing the surgeon sufficient time for adjustment operations; and by means of a swing conveying system (500) and support from the limiting part (110) on the inner wall of the atrium (300), the limiting part (110) can be shaped according to the structural form of the inner wall of the atrium (300), thereby eliminating a gap (400) between the limiting part (110) and the inner wall of the atrium (300).

Description

Interventional mitral valve holder with claws on both sides and intervening mitral valve

technical field

The present application relates to the technical field of medical devices, and in particular to an interventional mitral valve holder with claws on both sides and an interventional mitral valve.

Background technique

For the human mitral valve, there are large differences due to individual differences. During the implantation of the interventional valve, a long period of adjustment is required before the valve is separated from the delivery system. During this period, the native valve is stretched by the interventional valve and loses its original function. The intervening valve that is being adjusted begins to work.

Traditionally, there are three, four or more claws for mitral valve holders. Before the release of the interventional mitral valve, three, four or more income claws are fixed in the delivery system at the same time, forming support for each other, so that the interventional mitral valve and the delivery system form a stable rigid structure; and Since the delivery system is limited by the apex of the heart, it cannot move horizontally or vertically, and can only swing at the point of contact between the delivery system and the apex of the heart, so that the angle between the brim of the mitral valve and the atrial wall cannot be changed As a result, the brim of the hat cannot fit well with the atrial wall, resulting in difficulty in endothelialization.

application content

The purpose of this application is to provide an interventional mitral valve frame and an interventional mitral valve with claws on both sides, so as to solve the problem that the brim of the interventional mitral valve cannot be guaranteed to be in contact with the atrial wall during the implantation adjustment process of the above-mentioned prior art. fit problem.

The first aspect of the present application provides an interventional mitral valve holder with claws on both sides, including:

Body, one end of the body forms a stopper, the other end of the body is provided with two receiving claws, the projection of the body in the direction of implantation is elliptical or D-shaped, and the receiving claws are set on the Both ends of the body in the direction of the long axis.

In a possible implementation manner, in the short axis direction of the body, one end of the body is inclined toward the other end of the body.

In a possible implementation manner, the two receiving claws are arc-shaped, and the receiving claws are drawn toward the center of the body.

In a possible implementation manner, when the body is stretched, the limiting portion is folded toward the outside of the body.

In a possible implementation manner, the body includes a plurality of connecting ribs, and when the body is in a stretched state, each of the connecting ribs is connected to form a network.

In a possible implementation manner, the body and the receiving claw are integrally formed.

The second aspect of the present application also provides an interventional mitral valve, which includes the interventional mitral valve holder provided in the first aspect of the application, and the interventional mitral valve also includes a valve leaflet and a valve skirt, and the valve skirt The inner wall of the intervening mitral valve frame is fixedly covered, and the leaflet is connected to the valve skirt.

The technical solution provided by the application can achieve the following beneficial effects:

The intervening mitral valve frame and the intervening mitral valve with claws on both sides provided by this application can adjust the limit part by setting two retracting claws at both ends of the long axis of the valve frame, and by pulling the retracting claws The height of the two ends in the direction of the long axis ensures that the limit part fits reliably with the inner wall of the atrium, so that the interventional valve can replace the original valve during the adjustment period, avoiding the problem of blood flow being blocked or unable to pass during the adjustment period, and allowing the operator to have Fully adjust the operation time, and through the swing delivery system, and the support of the limiting part on the inner wall of the atrium, the limiting part can be shaped according to the shape and structure of the inner wall of the atrium, and the gap between the limiting part and the inner wall of the atrium can be eliminated.

It is to be understood that both the foregoing general description and the following detailed description are exemplary only and are not restrictive of the application.

Description of drawings

FIG. 1 is a schematic structural view of an intervening mitral valve holder with claws on both sides provided by the embodiment of the present application;

Fig. 2 is the front view of the interventional mitral valve holder with claws on both sides provided by the embodiment of the present application;

Fig. 3 is a side view of an interventional mitral valve holder with claws on both sides provided by the embodiment of the present application;

Fig. 4 is a top view of an intervening mitral valve holder with claws on both sides provided by the embodiment of the present application;

Fig. 5 is a state diagram of a state where there is a gap after the limit part of the intervening mitral valve frame with claws on both sides provided by the embodiment of the present application is fitted to the inner wall of the atrium;

Fig. 6 is a state view of the intervening mitral valve holder with claws on both sides provided by the embodiment of the present application, after the limiting part is fitted to the inner wall of the atrium without gaps.

Reference signs:

100-body;

110-limiting part;

120-connecting rib;

200 - income claw;

300 - atrium;

400-gap;

500 - conveyor system;

600 - apex;

610-holes.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the application and together with the description serve to explain the principles of the application.

Detailed ways

In order to make the purpose, technical solution and advantages of the present application clearer, the present application will be further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain the present application, and are not intended to limit the present application.

In the description of this application, unless otherwise clearly specified and limited, the terms "first" and "second" are only used for the purpose of description, and cannot be understood as indicating or implying relative importance; unless otherwise specified or stated , the term "plurality" refers to two or more; the terms "connection", "fixation" and so on should be understood in a broad sense, for example, "connection" can be a fixed connection, a detachable connection, or an integrated Connected, or electrically connected; either directly or indirectly through an intermediary. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application according to specific situations.

In the description of this specification, it should be understood that the orientation words such as "up" and "down" described in the embodiments of the present application are described from the perspective shown in the drawings, and should not be interpreted as a description of the embodiments of the present application. limited. Furthermore, in this context, it also needs to be understood that when it is mentioned that an element is connected "on" or "under" another element, it can not only be directly connected "on" or "under" another element, but can also To be indirectly connected "on" or "under" another element through an intervening element.

The human mitral valve varies greatly from individual to individual. When it is necessary to implant an interventional valve, it is usually necessary to use a delivery system as a carrier to make the interventional valve be bundled in the delivery system, and be connected to the delivery system through the receiving claws on the interventional valve. Then, the interventional valve is moved to the position to be implanted in the human body by the delivery system and released.

For the interventional mitral valve, after the interventional mitral valve is released, it can be automatically stretched and riveted to the implantation site. However, after the intervening mitral valve is stretched, due to the differences in the shape of the human mitral valve due to individual differences, the cap brim of the intervening mitral valve cannot fully fit the atrial wall, that is, there is a gap between the cap brim and the atrium wall , this gap will cause problems such as paravalvular leakage and inability to endothelialize, which poses a great safety hazard to the human body. Therefore, before the intervening mitral valve is separated from the delivery system, a long period of adjustment is required so that the brim of the intervening valve can fit the inner wall of the atrium, and during this adjustment, the native valve is inserted into the mitral valve. The strut shape loses its original function, and at this time it is necessary to make the interventional mitral valve, which is still in adjustment, begin to replace the native valve.

Wherein, traditionally, there are three, four or more claws for inserting into the mitral valve holder. Before the release of the interventional mitral valve, three, four or more income claws are fixed in the delivery system at the same time, forming support for each other, so that the interventional mitral valve and the delivery system form a stable rigid structure; and Since the delivery system is limited by the apex of the heart, it cannot move horizontally or vertically, and can only swing at the point of contact between the delivery system and the apex of the heart, so that the angle between the brim of the mitral valve and the atrial wall cannot be changed As a result, the brim of the hat cannot fit well with the atrial wall, resulting in difficulty in endothelialization.

At the same time, during the adjustment period of the interventional mitral valve implantation, because three, four or more income claws are restricted by the delivery system to be brought together, the interventional mitral valve cannot be fully opened during the adjustment period, resulting in difficulty in blood circulation. Flow, if the mitral valve is adjusted in this state, it will cause hypoxia in the human body due to the difficulty in blood flow during the adjustment period, threatening life. However, the existing interventional mitral valve can only be fully opened after it is completely separated from the delivery system, which causes the blood flow to be blocked or unable to pass through during the adjustment period, so that the operator does not have sufficient adjustment operation time, which affects the quality of the operation.

For this reason, as shown in Fig. 1 to Fig. 4, the application provides a kind of intervening mitral valve frame (hereinafter referred to as the valve frame) with claws on both sides, which includes a body 100, and one end of the body 100 forms a limiting portion 110. The limiting part 110 can also be called the brim. After the interventional mitral valve (hereinafter referred to as the interventional valve) is implanted, the limiting part 110 can be attached to the inner wall of the atrium 300 to realize the limitation and prevent the interventional valve Break away and fall into the ventricle. The other end of the main body 100 is provided with two receiving claws 200. The projection of the main body 100 on the implantation direction is elliptical or D-shaped. The elliptical or D-shaped main body 100 has a long axis and a short axis. Two ends of the main body 100 in the direction of the long axis.

During the delivery of the interventional valve, the delivery system 500 can pass through the hole 610 on the apex 600, and the hole 610 can support the delivery system 500, and due to the restriction of the hole 610, the delivery system 500 can be prevented from moving in a direction perpendicular to the hole 610. Displacement occurs in the axis direction to ensure the stability and delivery accuracy of the delivery system 500 . Wherein, since the tissue of the apex 600 is relatively soft, the delivery system 500 can swing with the hole 610 as a fulcrum, so as to realize the adjustment of the interventional valve. During the release process of the interventional valve, the two receiving claws 200 are kept connected with the delivery system 500 , and the slow release of the interventional valve can be realized through the traction of the delivery system 500 to the receiving claws 200 .

Wherein, during the adjustment period before the interventional valve is fully released, the main body 100 has been separated from the delivery system 500, and since the two receiving claws 200 are located at opposite ends of the main body 100, there will not be more than three receiving claws 200 formed between the two receiving claws 200. The relatively stable rigid structure formed between the income claws 200, the main body 100 can be stretched in the direction of its short axis, so that the blood can flow and supply oxygen to the human body, so that the main body 100 is separated from the delivery system 500, and the two income When the claw 200 is kept connected with the delivery system 500, there is enough adjustment time to adjust the height of the two ends of the stopper 110 in the long axis direction by pulling the receiving claw 200, so as to ensure that the stopper 110 is reliably connected to the inner wall of the atrium 300. Fitting allows the interventional valve to replace the original valve during the adjustment period, avoiding the problem of blood flow being blocked or unable to pass during the adjustment period, allowing the operator to have sufficient adjustment operation time to ensure the quality of the operation.

Specifically, as shown in Fig. 5 and Fig. 6, during the adjustment period, since the delivery system 500 is restricted by the apex 600, it is difficult to displace in the radial direction of the hole 610 on the apex 600, but the delivery system 500 and the hole of the apex 600 The contact position of 610 can be formed as the fulcrum of the delivery system 500, and the apical tissue is relatively soft, the delivery system 500 can swing on this fulcrum, so that the delivery system 500 can pull the two receiving claws 200, and can adjust the two receiving claws 200 pulling amplitude, for example, when the conveying system 500 pulls the receiving claw 200 at the left end, the left end of the body 100 can swing to the direction in which the receiving claw 200 at the left end is pulled, and when the conveying system 500 pulls the receiving claw 200 at the right end At this time, the right end of the main body 100 can swing to the direction in which the retracting claw 200 at the right end is pulled, thereby realizing the adjustment of the position of the main body 100, ensuring that the stopper 110 can fully fit the inner wall of the atrium 300, preventing paravalvular leakage and easy Endothelialization. Wherein, the left end and the right end of the body 100 are two ends in the long axis direction of the body 100 .

Wherein, the two receiving claws 200 have a certain degree of elasticity and have relatively large deformability. During the implantation adjustment period, through the swing delivery system 500 and the support of the limiting part 110 on the inner wall of the atrium 300, the limiting part 110 can be shaped according to the shape and structure of the inner wall of the atrium 300, so that the limiting part 110 can be aligned with the atrium 300. The inner wall is fully fit to provide good conditions for the later endothelialization.

It should be noted that after the existing interventional mitral valve is stretched at the implantation site, a gap 400 is likely to appear between the front end or rear end of the interventional mitral valve in the short axis direction and the inner wall of the atrium 300, resulting in poor fit. cause paravalvular leak. For the existing interventional valve with more than three income claws 200, since a relatively stable rigid structure is formed between more than three income claws 200, the interventional valve cannot be independently adjusted to the front end or the rear end. When the claws 200 are pulled, the whole of the interventional valve moves or swings synchronously, which also causes one end of the interventional valve to be adjusted to eliminate the gap 400, but a new gap 400 appears at the other end or causes the gap 400 at the other end to expand. In addition, if more than three receiving claws 200 have two ends respectively located in the short axis direction of the interventional valve, the interventional valve will become flatter during the release process, affecting the passage of blood flow.

For this reason, in this application, by arranging two receiving claws 200 in the long axis direction of the main body 100, the above-mentioned stable rigid structure will not be formed between the two receiving claws 200, and the elastic deformation of various parts of the main body 100 can be enhanced. ability, when pulling the receiving claw 200 at one end, the body 100 located on both sides of the receiving claw 200 can be slightly deformed, so that the limiting parts 110 near the two sides of the receiving claw 200 can follow the deformation of the main body 100 and the atrium The inner wall of 300 is fully fitted, and the position away from the receiving claw 200 on the body 100 may not be deformed, so that by pulling any one receiving claw 200, the position on the limit part 110 close to the corresponding receiving claw 200 can be realized. Adjust without affecting other parts of the limiting part 110, thereby effectively eliminating the gap 400 between the limiting part 110 and the inner wall of the atrium 300 in the direction of the short axis of the main body 100, preventing paravalvular leakage and ensuring the quality of the operation.

Specifically, in the short axis direction of the body 100 , one end of the body 100 is inclined toward the other end of the body 100 . In this way, it can better match the shape of the original mitral valve, so that the interventional valve can naturally fit the implantation site when it is released, reducing the frequency of adjustment and shortening the operation time.

Specifically, the two retracting claws 200 can be arc-shaped, and the retracting claws 200 are drawn toward the center of the body 100, so that when the interventional valve needs to be completely released, the retracting claws 200 can be easily separated from the delivery system 500, and the retracting claws 200 can be avoided from being separated from the delivery system 500. The system 500 or the internal tissues of the human body interfere.

Specifically, when the main body 100 is stretched, the limiting portion 110 is folded to the outside of the main body 100 , so that the limiting portion 110 can be attached to the inner wall of the atrium 300 to realize the limiting.

Specifically, the body 100 includes a plurality of connecting ribs 120 , and when the body 100 is stretched, each connecting rib 120 is connected to form a network. The main body 100 in the form of a network has the ability to elastically deform, and can realize two states of contraction and expansion. In the contracted state, the valve frame can be contained in the delivery system 500. Released at the implant site, and can abut against the inner wall of the implant site to achieve riveting.

Specifically, in order to facilitate processing and ensure the integrity of the structure, the body 100 and the receiving claw 200 can be integrally formed.

The embodiment of the present application also provides an intervening mitral valve, which includes valve leaflets, a valve skirt and the intervening mitral valve frame provided in any embodiment of the application, the valve skirt is fixedly covered on the inner wall of the intervening mitral valve frame, The leaflets are attached to the petal skirt. By setting two receiving claws 200 at both ends of the long axis of the valve frame, by pulling the receiving claws 200, the height of the two ends of the limiting part in the direction of the long axis can be adjusted to ensure that the limiting part fits reliably with the inner wall of the atrium. The interventional valve can replace the original valve during the adjustment period, avoiding the problem of blood flow being blocked or unable to pass through during the adjustment period, so that the operator has sufficient adjustment operation time to ensure the quality of the operation.

The above descriptions are only preferred embodiments of the present application, and are not intended to limit the present application. For those skilled in the art, there may be various modifications and changes in the present application. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of this application shall be included within the protection scope of this application.

Claims

An interventional mitral valve holder with claws on both sides, characterized in that it includes:

The main body (100), one end of the main body (100) forms a stopper (110), and the other end of the main body (100) is provided with two receiving claws (200), and the main body (100) is positioned in the direction of implantation The projection above is elliptical or D-shaped, and the receiving claws (200) are arranged at both ends of the main body (100) in the direction of the long axis.
The interventional mitral valve frame with claws on both sides according to claim 1, characterized in that, in the short axis direction of the body (100), one end of the body (100) faces toward the body ( 100) the other end is inclined.
The interventional mitral valve holder with claws on both sides according to claim 1, characterized in that, the two retraction claws (200) are arc-shaped, and the retraction claws (200) are toward the body ( 100) center gathers.
The interventional mitral valve holder with claws on both sides according to claim 1, characterized in that, when the main body (100) is stretched, the limiting part (110) moves toward the main body (100) ) with the outer fold.
The interventional mitral valve frame with claws on both sides according to claim 1, characterized in that, the body (100) includes a plurality of connecting ribs (120), and the body (100) is in a stretched state , each of the connecting ribs (120) is connected to form a network.
The interventional mitral valve holder with claws on both sides according to any one of claims 1-5, characterized in that, the body (100) and the retracting claws (200) are integrally formed.
An intervening mitral valve, characterized in that it includes the intervening mitral valve holder described in any one of claims 1-6, the intervening mitral valve also includes valve leaflets and a valve skirt, and the valve skirt is fixedly covered on The inner wall of the intervening mitral valve frame, the leaflets are connected to the valve skirt.