WO2023000579A1

WO2023000579A1 - Mitral valve intervention valve and delivery system

Info

Publication number: WO2023000579A1
Application number: PCT/CN2021/134822
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: 2021-07-21
Filing date: 2021-12-01
Publication date: 2023-01-26
Also published as: CN113349987A

Abstract

The present application relates to a mitral valve intervention valve and a delivery system. The intervention valve comprises a valve frame, a valve skirt, and valve leaflets; the valve skirt fixedly covers the inner wall of the valve frame; the valve leaflets are connected to the valve skirt; when the valve frame is in a spread state, an everted structure is formed at one end of the valve frame. The intervention valve further comprises an adjustment structure; one end of the adjustment structure is fixed to the valve frame or the valve skirt; and the other end of the adjustment structure is an operating end configured to adjust an implantation position of the mitral valve intervention valve by means of external pulling. According to the present application, an implantation state can be further adjusted by means of the adjustment structure after implantation, so as to ensure that the implantation position of the intervention valve can effectively match the valve annulus, and prevent the occurrence of paravalvular leakage. In addition, the operating end of the adjustment structure can be fixed at the apex of heart to always yield a restrain effect on the intervention valve, and ensures, in conjunction with structures such as barbs, reliable matching between the intervention valve and the valve annulus, thereby preventing paravalvular leakage caused by non-effective matching with the valve annulus due to the movement of the intervention valve toward the direction of the atrium.

Description

Mitral valve interventional valve and delivery system

technical field

The present application relates to the technical field of medical devices, in particular to a mitral valve interventional valve and a delivery system.

Background technique

The interventional therapy of transapical mitral valve is an emerging discipline. After opening the chest cavity, the mitral valve interventional valve is delivered to the position of the mitral valve annulus through the delivery system through the apex for release. However, due to the complex physiological structure of the mitral valve, the front and rear rings have a certain inclination angle, and the shape of the ring is D-shaped or elliptical, so there are high requirements for the release height and angle of the interventional valve; at the same time, Since the valve release claws used to release the interventional valve in the delivery system cannot be controlled independently by the delivery system, it is difficult to meet the requirements for the release height and angle of the valve at the same time, and thus the interventional valve and the valve ring cannot be effectively matched, which is easy cause paravalvular leak. In addition, the existing interventional valve still has the risk of relative movement between the valve annulus after working for a period of time after operation. If the interventional valve moves axially relative to the valve annulus, it will cause paravalvular leakage , There is even a risk of the involved valve detaching from the annulus.

application content

The purpose of the present application is to provide a mitral valve interventional valve and a delivery system to solve the above-mentioned problems in the prior art that the implantation position of the mitral valve interventional valve cannot be effectively matched with the annulus and reliably fixed.

The first aspect of the present application provides a mitral valve interventional valve, which includes a valve frame, a valve skirt and leaflets, the valve skirt is fixedly covered on the inner wall of the valve frame, and the valve leaflets are connected to the valve skirt, when the valve frame is stretched, one end of the valve frame is formed with an eversion structure;

The mitral valve interventional valve also includes an adjustment structure, one end of the adjustment structure is fixed to the valve frame or the valve skirt, and the other end of the adjustment structure is an operating end, which is used to adjust the valve by external force. Describe the implantation position of the mitral valve interventional valve.

In a possible design, the adjustment structure includes more than two connection ends, and the more than two connection ends are connected to different positions in the circumferential direction of the valve frame or the valve skirt at intervals.

In a possible design, the adjustment structure is a pulling wire.

In a possible design, the adjusting structure is fixed on an end of the valve frame away from the everted structure.

In a possible design, the flap frame includes a plurality of connecting beams, and when the flap frame is stretched, a plurality of hollow parts are formed between the plurality of connecting beams, and one end of the adjustment structure is fixed on on the connecting beam.

In a possible design, the length of the pulling wire is greater than 8cm.

In a possible design, the number of the pulling wires is two or more.

In a possible design, the colors of the two or more pulling wires are different.

In a possible design, the pulling thread is one of polytetrafluoroethylene thread, nylon thread, polyester thread, polyester thread, polypropylene thread and polyethylene thread.

The second aspect of the present application also provides a delivery system, which includes the mitral valve intervention valve provided in the first aspect of the application, the delivery system includes a proximal end and a distal end, and the distal end of the delivery system is provided with a useful a fixing structure for fixing the mitral valve interventional valve;

A hollow passage is provided in the delivery system, and the end of the adjustment structure away from the valve holder passes through the hollow passage and leads out from the proximal end of the delivery system;

Alternatively, one end of the adjustment structure away from the valve holder is fixed to the delivery system.

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

The mitral valve interventional valve and delivery system provided by this application can further adjust the implantation state by adjusting the structure after implantation, so as to ensure that the implantation position of the interventional valve can effectively match the valve annulus and prevent paravalvular leakage.

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 state diagram when the existing interventional valve and valve ring are badly matched;

Fig. 2 is a schematic structural diagram of the mitral valve interventional valve provided by the embodiment of the present application;

Fig. 3 is a state diagram of the mitral valve interventional valve provided by the embodiment of the present application without adjustment after implantation;

Fig. 4 is a diagram of the adjusted state of the mitral valve interventional valve provided by the embodiment of the present application after implantation.

Reference signs:

1-petal frame;

11-valgus structure;

12 - connecting beam;

2- Regulatory structure;

21-connection end;

3 - atrium;

4 - Ventricles;

5-valve ring;

6- Intervening valve;

7 - Gap.

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 description

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. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood 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 mitral valve is the left atrioventricular valve, which includes an anterior cusp located anteromedially and a posterior cusp located posterolaterally. The mitral valve can ensure blood circulation from the left atrium to the left ventricle and through a certain flow. When the left ventricle contracts, the blood in the chamber is squeezed, the blood hits the valve, the mitral valve closes, and the blood does not flow into the left atrium.

When the mitral valve is diseased, an artificial valve can be implanted in the body through interventional means to replace the function of the original mitral valve. The intervention method is to send the artificial valve to the implantation site through the delivery system, stretch the valve through the self-expanding property of the valve or expand the valve by means of a balloon, and rivet it on the corresponding annulus.

However, the physiological structure of the mitral valve is relatively complex and not a regular shape. In order to ensure that the implantation position of the mitral valve can have a good cooperation with the annulus after the release of the mitral valve, the release height and angle of the interventional valve have certain influences. Very demanding. If the interventional valve 6 cannot be fully matched with the annulus 5 after release, such as the release height of the interventional valve 6 is insufficient or the release angle is large, a large gap 7 will appear between the interventional valve 6 and the annulus 5, as shown in Figure 1 , which in turn will lead to the problem of paravalvular leakage, affecting the health of the patient, and even the risk of intervening the valve 6 and detaching from the valve annulus 5 .

To this end, as shown in Figures 2 to 4, the embodiment of the present application provides a mitral valve interventional valve (hereinafter also referred to as an interventional valve), which includes a valve frame 1, a valve skirt and leaflets, and the valve skirt is fixedly covered On the inner wall of the valve frame 1 , the leaflets are connected to the valve skirt. When the valve frame 1 is stretched, one end of the valve frame 1 forms an eversion structure 11 .

Wherein, the valve frame 1 is made of elastic material. When the interventional valve 6 is delivered into the heart through the delivery system, the valve holder 1 can be bundled into a tubular shape and installed in the delivery system, so that it can enter the heart with the delivery system. When the interventional valve 6 reaches the position of the lesion, the interventional valve 6 can partially pass through the annulus 5, and at the same time, the delivery system can release the interventional valve 6, and the interventional valve 6 is automatically stretched, and can be fixed to the annulus through barbs, etc. 5. At the same time, after the intervening valve 6 is stretched, an everted valgus structure 11 is formed at one end thereof, and the everted structure 11 can abut against the atrium 3, so as to realize the axial limit of the intervening valve 6 and prevent the intervening valve 6 Detach from annulus 5. At this time, when the ventricle 4 contracts, the blood in the chamber is squeezed, and the blood hits the valve, and the intervening valve 6 of the mitral valve closes, and the blood does not flow into the atrium 3 .

The interventional valve 6 provided in the embodiment of the present application also includes an adjustment structure 2, one end of the adjustment structure 2 is fixed to the valve frame 1 or the valve skirt, and the other end of the adjustment structure 2 is an operating end, which is used to pull by external force to Adjust the implantation position of the mitral valve interventional valve 6 .

In one operation, the operating end of the adjustment structure 2 is fixed to the delivery system and enters the human body together with the delivery system. After the interventional valve 6 is released, the delivery system is withdrawn from the human body, and the operation end of the adjustment structure 2 can be delivered by the delivery system. Taken out of the heart or outside the body, the operator can properly pull the operating end of the adjustment structure 2 to further adjust the cooperation state of the interventional valve 6 and the annulus 5, so that the interventional valve 6 can precisely cooperate with the annulus 5 to prevent paravalvular leakage . Specifically, the end of the adjustment structure 2 away from the operating end is mainly connected to the position on the valve frame 1 or the valve skirt that is likely to be poorly matched with the valve ring 5. There may be one position, or two or more positions. , when there are more than two such positions, the adjustment structure 2 can also be connected to more than two such positions respectively, when a certain position of the interventional valve 6 is poorly matched with the annulus 5, as shown in Figure 3 At the position of the gap 7, the adjustment structure 2 at the corresponding position or the adjustment structure 2 near the corresponding position can be properly pulled to adjust the interventional valve 6 at this position and the annulus 5 to cooperate reliably, as shown in FIG. 4 .

In another operation, the operating end of the adjustment structure 2 is led out of the heart or outside the human body through the delivery system, and remains outside the human body during the implantation of the interventional valve 6 . After the interventional valve 6 is released at the lesion, the operating end located outside the heart or the human body can be pulled to adjust the cooperation between the interventional valve 6 and the annulus 5 without waiting for the delivery system to be withdrawn from the human body, thereby improving the operation Efficiency; of course, in this mode of operation, it is also possible to withdraw the delivery system and operate the adjustment structure 2 at the same time, and it is also possible to operate the adjustment structure 2 after the delivery system is completely withdrawn from the human body, so the operation is flexible.

It should be emphasized that the release of the existing interventional valve 6 to the annulus 5 is a one-time operation, and the implantation state of the interventional valve 6 cannot be adjusted again after implantation. The mitral valve interventional valve 6 provided in the embodiment of the present application can further adjust the implantation state through the adjustment structure 2 after implantation, and the interventional valve 6 can work normally after being released into the annulus 5, according to the interventional valve The working state and implantation state of 6 can be finely adjusted through the adjustment structure 2, so that the interventional valve 6 can be effectively matched with the annulus 5, and paravalvular leakage can be prevented.

In addition, after the adjustment of the interventional valve 6 is completed, the operating end of the adjustment structure 2 can be fixed on the apex of the heart, so that the adjustment structure 2 can always have a restraining effect on the interventional valve 6, and cooperate with structures such as barbs to ensure that the intervention The reliable cooperation between the valve 6 and the valve annulus 5 prevents the intervening valve 6 from moving toward the atrium 3 and failing to cooperate with the valve annulus 5 to cause paravalvular leakage.

Specifically, the adjustment structure 2 includes more than two connecting ends 21, and the more than two connecting ends 21 are connected to different positions in the circumferential direction of the valve frame 1 or the valve skirt at intervals.

It should be noted that the anterior and posterior rings of the mitral valve have a certain inclination angle, and the shape of the ring is D-shaped or elliptical, which limits the interventional valve 6 to only have a unique implantation state that can match the valve ring 5. There is a deviation in the release height or release angle of the valve 6, and some positions on the interventional valve 6 cannot be effectively matched with the annulus 5, which may easily lead to paravalvular leakage, and the deviation may not be completely consistent due to possible deviations during operation , causing the position of the poor cooperation between the interventional valve 6 and the valve annulus 5 is also inconsistent.

For this reason, in this embodiment, the adjustment structure 2 includes more than two connecting ends 21, and the more than two connecting ends 21 are connected to different positions in the circumferential direction of the valve frame 1 or the valve skirt at intervals. When the interventional valve 6 has poor cooperation with the annulus 5 at different positions, the adjustment structure 2 at this position or the adjustment structure 2 near this position can be operated to adjust the interventional valve 6, thereby ensuring that the various positions of the interventional valve 6 In the released state, the adjusting structure 2 can be adjusted to the state of effectively cooperating with the annulus 5 to prevent paravalvular leakage.

Specifically, the adjustment structure 2 may be a pulling wire, and the pulling wire may specifically be one of polytetrafluoroethylene wire, nylon wire, polyester wire, polyester wire, polypropylene wire and polyethylene wire. There may be more than two pulling wires, and they are respectively fixed at different positions of the valve frame 1 or the valve skirt in the circumferential direction, so that the position where the interventional valve 6 is connected to the pulling wires can be adjusted by pulling the corresponding pulling wires. Mating state of ring 5.

It should be noted that the colors of two or more pulling lines are different. In this embodiment, there are preferably two traction wires, wherein one traction wire is connected to the anterior ring of the interventional valve 6 to adjust the position of the anterior ring through the traction wire; the other traction wire is connected to the rear of the interventional valve 6 ring to adjust the position of the rear ring via this pull wire. Since the implantation position of the interventional valve 6 in the heart generally needs to be determined by angiography, if the angiography shows that the implantation position of the interventional valve 6 cannot effectively match the annulus 5, the position of the interventional valve 6 can be adjusted by pulling the corresponding traction wire and combining with imaging. The implantation position is adjusted until the implantation position of the interventional valve 6 can effectively cooperate with the annulus 5 . However, the operation end of the traction wire is located outside the heart. If each traction wire is a line with the same appearance, the operator cannot distinguish the position where each traction wire is connected to the interventional valve 6, resulting in the inability to perform adjustment operations, and even misoperation and failure. The deviation of the implantation position of the interventional valve 6 is exacerbated. Therefore, in this implementation, by making the colors of the pulling wires different, the corresponding position connected to the interventional valve 6 can be accurately judged according to the color of the pulling wires, thereby ensuring the accuracy of the adjustment operation.

As a specific implementation, the adjustment structure 2 is fixed on the end of the valve frame 1 away from the eversion structure 11 . The eversion structure 11 and the traction wire are respectively located on both sides of the interventional valve 6 in the axial direction, so that the state of the interventional valve 6 can be adjusted conveniently by pulling the adjustment structure 2 .

As a specific implementation, the valve frame 1 includes a plurality of connecting beams 12. When the valve frame 1 is stretched, a plurality of hollow parts are formed between the connecting beams 12, and one end of the adjustment structure 2 is fixed to the connecting beams 12. superior. In this embodiment, the adjustment structure 2 is a pulling wire, which can be bound to the connecting beam 12 , which can ensure the reliable connection between the pulling wire and the interventional valve 6 without affecting the normal operation of the interventional valve 6 .

Specifically, the length of the pulling wire is greater than 8 cm, so as to ensure that after the interventional valve 6 is implanted, the operating end of the pulling wire can be pulled out from the human body for pulling operation. In this embodiment, the pulling line is preferably 30 cm.

The embodiment of the present application also provides a delivery system, which includes the mitral valve intervention valve 6 provided in any embodiment of the application, the delivery system includes a proximal end and a distal end, and in the art, the proximal end is closer to the operator The distal end is the end farther away from the operator, and the distal end of the delivery system is provided with a fixing structure for fixing the mitral valve interventional valve 6 . When the interventional valve 6 is delivered, the interventional valve 6 is bundled into a tubular shape and placed in the delivery system, while being fixed to the fixed structure; when the interventional valve 6 is released, the fixed structure can be separated from the interventional valve 6, so that the interventional valve 6 can automatically Stretch and cooperate with valve annulus 5.

Wherein, in one embodiment, a hollow channel may be provided in the delivery system, and the end of the adjustment structure 2 away from the valve holder 1 is led out from the proximal end of the delivery system through the hollow channel.

Specifically, the operating end of the adjustment structure 2 is led out of the human body through the delivery system, and remains outside the human body during the implantation of the interventional valve 6 . After the interventional valve 6 is released at the lesion, the operating end located outside the human body can be pulled to adjust the cooperation between the interventional valve 6 and the annulus 5 without waiting for the delivery system to be withdrawn from the human body, thereby improving the operating efficiency; of course , in this mode of operation, it is also possible to withdraw the delivery system and operate the adjustment structure 2 at the same time, and it is also possible to operate the adjustment structure 2 after the delivery system is completely withdrawn from the human body, and the operation is flexible.

In another embodiment, the end of the adjustment structure 2 away from the valve frame 1 is fixed to the delivery system. Specifically, the operating end of the adjustment structure 2 is fixed to the delivery system and enters the human body together with the delivery system. After the interventional valve 6 is released, the delivery system is withdrawn from the human body, and the operating end of the adjustment structure 2 can be taken out of the body by the delivery system. , the operator can properly pull the operating end of the adjustment structure 2 to further adjust the cooperation state of the interventional valve 6 and the annulus 5, so that the interventional valve 6 can precisely cooperate with the annulus 5 to prevent paravalvular leakage.

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

A mitral valve interventional valve, characterized in that it comprises a valve frame (1), a valve skirt and leaflets, the valve skirt is fixedly covered on the inner wall of the valve frame (1), and the valve leaflets are connected to the valve skirt, when the valve frame (1) is stretched, one end of the valve frame (1) is formed with an eversion structure (11);

The mitral valve interventional valve also includes an adjustment structure (2), one end of the adjustment structure (2) is fixed to the valve frame (1) or the valve skirt, and the other end of the adjustment structure (2) is The operating end is used to adjust the implantation position of the mitral valve interventional valve by being pulled by external force.
The mitral valve interventional valve according to claim 1, characterized in that, the adjustment structure (2) includes more than two connecting ends (21), and more than two connecting ends (21) are connected to the valve at intervals. frame (1) or at different positions in the circumferential direction of the valve skirt.
The mitral valve interventional valve according to claim 1 or 2, characterized in that the adjustment structure (2) is a traction wire.
The mitral valve interventional valve according to claim 3, characterized in that the adjustment structure (2) is fixed on the valve frame (1) at an end away from the everted structure (11).
The mitral valve interventional valve according to claim 4, characterized in that, the valve frame (1) includes a plurality of connecting beams (12), and the valve frame (1) is in a stretched state, and a plurality of the A plurality of hollow parts are formed between the connecting beams (12), and one end of the adjusting structure (2) is fixed on the connecting beams (12).
The mitral valve interventional valve according to claim 3, wherein the length of the pulling wire is greater than 8 cm.
The mitral valve interventional valve according to claim 3, wherein the number of the pulling wires is two or more.
The mitral valve interventional valve according to claim 7, wherein the colors of the two or more pulling wires are different.
The mitral valve interventional valve according to claim 3, wherein the traction wire is one of polytetrafluoroethylene wire, nylon wire, polyester wire, polyester wire, polypropylene wire and polyethylene wire.
A delivery system, characterized in that it includes the mitral valve intervention valve according to any one of claims 1-9, the delivery system includes a proximal end and a distal end, and the distal end of the delivery system is provided with a Describe the fixed structure of the mitral valve interventional valve;

A hollow channel is provided in the delivery system, and an end of the adjustment structure (2) away from the valve holder (1) passes through the hollow channel and is led out from the proximal end of the delivery system;

Alternatively, the end of the adjustment structure (2) away from the valve frame (1) is fixed to the delivery system.