Anchoring device and transcatheter artificial aortic valve system

Abstract

The utility model provides an anchoring device and a transcatheter artificial aortic valve system. The anchoring device is of an integrated structure and comprises an anchoring valve ring support at the telecentric end and an anchoring foot at the proximal end. The anchoring valve ring support is of a cylindrical net-shaped structure. The number of the anchoring feet is three, the anchoring feet are distributed on the periphery of the proximal end of the anchoring valve ring support, the anchoring feet have an abduction angle relative to the axis of the anchoring valve ring support, and each anchoring foot is of a C-shaped hollow structure. According to the anchoring device and the transcatheter artificial aortic valve system, after the anchoring device is released through a catheter, the anchoring foot is embedded into the aortic sinus bottom corresponding to the aorta root, the native valve is extruded between the anchoring foot and the artificial aortic valve, and a first anchoring state is formed; after the artificial aortic valve is expanded, the artificial aortic valve is tightly attached to the anchoring valve ring support and the aortic valve ring to form a second anchoring state; double anchoring provides a stable and reliable supporting effect for the artificial aortic valve.

Description

Technical Field

[0001] The present application relates to the technical field of transcatheter aortic valve implantation, and in particular to an anchoring device and a transcatheter artificial aortic valve system. Background Art

[0002] The research and clinical application of transcatheter aortic valve replacement (TAVR) have been going on for more than 20 years. Due to its advantages of minimal invasiveness, rapid recovery, and definite short- and medium-term effects, it has been recognized as an alternative surgical option for elderly or high-risk patients undergoing traditional surgical aortic valve replacement, and its indications are gradually expanding to low-risk and younger patients. Currently, millions of patients with aortic valve diseases worldwide have benefited, with an annual growth rate of 40%.

[0003] Aortic valve regurgitation is a common form of valvular heart disease. According to the data of the Chinese Registry of Valvular Heart Disease, among patients with moderate to severe aortic valve disease in China, the proportion of pure aortic valve regurgitation is as high as 38.8% at most. Since the valves of patients with pure aortic valve regurgitation often lack calcification, the leaflets are softer, and there are often dilations of the aortic valve annulus and ascending aorta, which lead to difficult valve anchoring and risks such as valve displacement or even detachment, obstruction of the coronary artery opening, severe perivalvular leakage, and postoperative conduction block. If the interventional aortic valve can ensure accurate positioning and stable anchoring after being released in the body, the above problems are expected to be solved.

[0004] Currently, only the foreign J-Valve valve system is certified for use in patients with aortic valve regurgitation, while there is no special valve system for aortic valve regurgitation in China, and the existing TAVR valves cannot meet the treatment needs of such patients. Summary of the Invention

[0005] To solve the existing technical problems, the present application provides an anchoring device and a transcatheter artificial aortic valve system that can provide accurate positioning and stable anchoring.

[0006] To achieve the above object, the technical solution of the embodiment of the present application is realized as follows:

[0007] On the one hand, the embodiment of the present application provides an anchoring device. The anchoring device is an integrated structure and includes an anchoring annulus stent at the distal end and anchoring feet at the proximal end. The anchoring annulus stent is in a cylindrical mesh structure. There are 3 anchoring feet distributed on the outer periphery of the proximal end of the anchoring annulus stent. The anchoring feet have an abduction angle relative to the axis of the anchoring annulus stent, and each anchoring foot is in a C-shaped hollow structure.

[0008] In one embodiment, each anchoring foot includes a connecting section and an arc section. The connecting sections are arranged at both ends of the arc section and are connected to the proximal end of the anchoring annulus stent.

[0009] In one embodiment, the anchoring annulus stent includes an axial segment, a peak segment and a valley segment. A plurality of the axial segments are arranged around the axis in a direction parallel to the axis of the anchoring annulus stent. The peak segment is arc-connected to the proximal ends of two adjacent axial segments, and the valley segment is arc-connected to the distal ends of two adjacent axial segments, so that the anchoring annulus stent is in a shape formed by a metal wire traveling back and forth in a direction parallel to the axis and connected end to end.

[0010] In one embodiment, the connecting segment extends from the proximal end of the axial segment, and the arc segment is curve-connected to two adjacent connecting segments and the proximal ends thereof expand outward.

[0011] In one embodiment, the abduction angle of the plane where the arc segment is located relative to the axis direction of the anchoring annulus stent is between 25° and 40°.

[0012] In one embodiment, the axial length of the anchoring annulus stent is 2-20 mm and the diameter is 24-40 mm.

[0013] In one embodiment, the radial length of the anchoring foot is 10-25 mm.

[0014] In one embodiment, three fixing rings are respectively arranged at the distal end of the anchoring annulus stent corresponding to the connection points of the three anchoring feet.

[0015] On the other hand, an embodiment of the present application provides a transcatheter artificial aortic valve system, including the anchoring device, a delivery sheath and an artificial aortic valve according to the foregoing description. The anchoring device can be transformed between a first form and a second form; the first form is the working form of the anchoring device after being implanted into the human aortic root, and the second form is the form in which the anchoring device is compressed and loaded into the delivery sheath.

[0016] In one embodiment, the diameter of the anchoring annulus stent is less than or equal to the diameter of the artificial aortic valve.

[0017] The anchoring device and the transcatheter artificial aortic valve system of the present application have at least the following beneficial effects: In the anchoring device and the transcatheter artificial aortic valve system of the present application, after the anchoring device is released into the aortic root through a catheter, three anchoring feet distributed around the anchoring annulus stent are embedded into the bottoms of three corresponding aortic sinuses of the aortic root, so that the entire anchoring device cannot fall downward into the left ventricular outflow tract or the left ventricle. After the artificial aortic valve is implanted, the native valve is squeezed between the anchoring feet and the artificial aortic valve, forming a first-stage anchoring state; after the artificial aortic valve is expanded, it closely abuts against the anchoring annulus stent and the aortic annulus, forming a second-stage anchoring state; the dual anchoring provides a stable and reliable supporting effect for the artificial aortic valve, making it possible to perform transcatheter aortic valve replacement for patients with non-calcified and non-anchoring simple aortic valve regurgitation. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 FIG. 6 is a schematic perspective view of the anchoring device in the first form according to an embodiment of the present application;

[0019] Figure 2 is Figure 1 the front view structural schematic diagram of the anchoring device in FIG. 6;

[0020] Figure 3 is Figure 1 the top view structural schematic diagram of the anchoring device in FIG. 6;

[0021] Figure 4 is Figure 1 the bottom view structural schematic diagram of the anchoring device in FIG. 6;

[0022] Figure 5 is Figure 1 the partial enlarged structural schematic diagram of the anchoring annulus stent of the anchoring device in FIG. 6;

[0023] Figure 6 is Figure 1 the partial enlarged structural schematic diagram of the anchoring device in FIG. 6;

[0024] Figure 7A , Figure 7B , Figure 7C FIGS. 44, 45, and 46 are respectively schematic diagrams of the release process of the anchoring device of the transcatheter artificial aortic valve system according to an embodiment of the present application;

[0025] Figure 8 FIG. 48 is a schematic diagram of the transcatheter artificial aortic valve system being sent into the aortic root for release in FIG. 7;

[0026] Figure 9 FIG. 52 is a schematic diagram after the transcatheter artificial aortic valve system in FIG. 7 is released in the aortic root.

[0027] The reference numerals of the components in the figures are as follows:

[0028] Anchoring device 100;

[0029] Anchoring annulus stent 10 (wherein, axial section 11, peak section 12, valley section 13);

[0030] Anchoring foot 20 (wherein, connecting section 21, arc section 22);

[0031] Fixing ring 30;

[0032] Delivery sheath 200. Specific embodiments

[0033] The technical solution of the present application will be further elaborated in detail below in conjunction with the accompanying drawings of the specification and specific embodiments.

[0034] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which this application belongs. The terms used in the specification of this application herein are only for the purpose of describing specific embodiments and are not intended to limit the implementation of this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0035] In the description of this application, it should be understood that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing this application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to this application. In the description of this application, unless otherwise stated, the meaning of "a plurality of" is two or more.

[0036] In the description of this application, it should be noted that unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0037] In the anchoring device of this application and the transcatheter artificial aortic valve system, the anchoring device assists in transcatheter aortic valve implantation and is used to provide support and anchoring for transcatheter aortic valve implantation (TAVR) in patients with pure aortic valve regurgitation. After implanting this anchoring device, it makes it possible to perform transcatheter aortic valve replacement in patients with non-calcified pure aortic valve regurgitation.

[0038] Please refer to Figure 1 、 Figure 2 、 Figure 3 and Figure 4 , which is a schematic structural view of the anchoring device 100 in the first form of an embodiment of the present application. The anchoring device 100 can transform between a relaxed first form (such as the form shown in Figure 1 ) and a compressed second form. Among them, the first form is the working form of the anchoring device 100 after being implanted and deployed at the root of the human aortic artery; the second form is a compressed strip shape, that is, the delivery form of the anchoring device 100 when it is delivered through a catheter.

[0039] The transcatheter aortic valve implantation anchoring device 100 of an embodiment of the present application is an integrated structure, including an anchoring annulus stent 10 at the distal end and an anchoring foot 20 at the proximal end. Among them, the anchoring annulus stent 10 is fixedly connected to the anchoring foot 20. The connection method between the anchoring annulus stent 10 and the anchoring foot 20 can be integrally formed by means such as winding with an integrated shape memory wire, laser engraving, or 3D printing. Different from other split-type or anchoring devices with welding points, the integrated structure of the anchoring device 100 is more firm and stable, effectively avoiding the uneven system quality caused by the change of welding temperature during the production process of traditional positioning anchoring devices, enabling mass production, and ensuring the stable and reliable quality of the system. The anchoring foot 20 has a certain abduction angle relative to the anchoring annulus stent 10, and the anchoring annulus stent 10 and the anchoring foot 20 have a dual anchoring effect.

[0040] The anchoring annulus stent 10 is in a cylindrical mesh structure and has a certain range of expandable potential, which can match various different models of artificial aortic valves and different degrees of aortic annulus dilation and ascending aorta dilation lesions. The anchoring annulus stent 10 is formed by winding in a "roundabout" mesh shape, and the long axis of the roundabout shape is parallel to the axis of the anchoring annulus stent 10.

[0041] Please refer to Figure 5 more specifically. The anchoring annulus stent 10 includes an axial section 11, a wave crest section 12, and a wave trough section 13. A plurality of axial sections 11 are arranged around the axis along the direction parallel to the axis of the anchoring annulus stent 10. The wave crest section 12 is arc-connected to the proximal ends (upper ends) of two adjacent axial sections 11, and the wave trough section 13 is arc-connected to the distal ends (lower ends) of two adjacent axial sections 11, so that the anchoring annulus stent 10 can be formed by a metal wire winding back and forth in the direction parallel to the axis and connecting the head and tail. The axial length of the anchoring annulus stent 10 is 2-20 mm, and the diameter is 24-40 mm. A variety of different models can be set within this size range. The "roundabout" structure of the anchoring annulus stent 10 gives it a large range of expandable potential. After implantation, it can be applicable to different degrees of annulus and ascending aorta dilation lesions, and at the same time can match various different models of artificial aortic valves.

[0042] There are three anchoring feet 20, which are evenly distributed on the outer periphery of the proximal end of the anchoring annulus stent 10 and correspond one by one to the bottoms of the three aortic sinuses corresponding to the aortic root. They are used to embed into the bottoms of the aortic sinuses at the root of the ascending aorta to accurately position and fix the anchoring feet 20 of the system. When the artificial aortic valve prosthesis is implanted, the native valve is clamped between the two, forming the first anchoring state. Each anchoring foot 20 has a "C"-shaped hollow structure, so as not to block the coronary artery opening and affect coronary blood flow.

[0043] Please refer to Figure 6 , more specifically, each anchoring foot 20 includes a connecting section 21 and an arc section 22. The connecting section 21 is arranged at both ends of the arc section 22 and is connected to the proximal end of the anchoring annulus stent 10. The connecting section 21 extends upward from the proximal end (upper end) of the axial section 11 of the anchoring annulus stent 10. The arc section 22 is curve-connected to two adjacent connecting sections 21 and the upper end expands outward. The radial length of the anchoring foot 20 is 10-25 mm; the abduction angle between the plane where the arc section 22 of the anchoring foot 20 is located and the axis direction of the anchoring annulus stent 10 is between 25° and 40°, and the optimal abduction angle is 30°. After the anchoring foot 20 is unfolded relative to the anchoring annulus stent 10 (in the first form), it forms a petal-like shape with a hollow in the middle and no membrane covering, and there is no risk of blocking the coronary artery opening after implantation.

[0044] After the anchoring device 100 is released into the aortic root through the catheter, the three anchoring feet 20 evenly distributed around the anchoring annulus stent will accurately embed into the bottoms of the three corresponding aortic sinuses at the aortic root; after the artificial aortic valve is implanted, the native valve is squeezed between the anchoring annulus stent 10 and the artificial aortic valve, so that the anchoring annulus stent 10 cannot drop downward into the left ventricular outflow tract or the left ventricle, which is the first anchoring state; the diameter of the anchoring annulus stent 10 is slightly smaller than or equal to the diameter of the subsequent selected artificial aortic valve. After the artificial aortic valve prosthesis is implanted, it closely abuts against the anchoring annulus stent 10 and the aortic annulus, which is the second anchoring state. The anchoring device 100 provides double anchoring forces to provide anchoring and support for the subsequent implantation of the artificial aortic valve.

[0045] To facilitate the fixation of the anchoring device 100 during catheter delivery in the second form, at the end of the anchoring annulus stent 10 at the distal end of the connection between the three anchoring feet 20 (the lowest point of the wave trough section 13), three fixing rings 30 are provided, which can be buckled to the fixing nails of the delivery system, so that the artificial aortic valve will not shift during loading and release and can be retrieved if necessary.

[0046] Please refer to Figure 7A 、 Figure 7B and Figure 7C, a transcatheter artificial aortic valve system according to an embodiment of the present application includes an anchoring device 100, a delivery sheath 200, and an artificial aortic valve (not shown in the figure). The anchoring device 100 can be loaded into the delivery sheath 200 in a second configuration and delivered through the delivery sheath 200.

[0047] Please refer to Figure 8 and Figure 9 , the process of the transcatheter artificial aortic valve system of the present application is as follows:

[0048] (a) In ice-saline, use a compressor to compress the anchoring device 100 into a thin strip in the second configuration. Buckle the fixing ring 30 onto the fixing nail of the delivery system and place the entire anchoring device 100 into the delivery sheath 200. The anchoring device 100 cannot be fully deployed in the delivery sheath 200 due to the restriction of the tube wall, as Figure 7A shown in;

[0049] (b) Along the guide wire, deliver the delivery sheath 200 equipped with the anchoring device 100 to a predetermined position in the ascending aorta;

[0050] (c) Slowly withdraw the delivery sheath 200. First, open the anchoring feet 20 and push them towards the ventricular direction. While pushing, rotate the delivery sheath 200 so that the 3 anchoring feet 20 correspond to the 3 coronary sinus positions, and further push towards the ventricular direction until the 3 anchoring feet 20 are respectively stuck at the 3 aortic sinuses, without falling into the left ventricular outflow tract or the left ventricle and without affecting the cardiac conduction system, as Figure 7B and Figure 8 shown in;

[0051] (d) Continue to completely withdraw the delivery sheath 200, release the anchoring annulus stent 10 and the entire anchoring device 100. The anchoring device 100 will be fixed above the annulus level, playing an anchoring role for subsequent implantation of the artificial aortic valve prosthesis, as Figure 7C and Figure 9 shown in. When reaching the predetermined position, after withdrawing the delivery sheath, the anchoring device 100 will resume the designed shape, that is, the first configuration.

[0052] In summary, after the anchoring device of the present application is released through a catheter into the aortic root, the three anchoring feet evenly distributed around the annulus stent will accurately embed into the bottoms of the corresponding three aortic sinuses in the aortic root, preventing the entire anchoring device from slipping downward into the left ventricular outflow tract or the left ventricle. After the implantation of the artificial aortic valve, the native valve is squeezed between the anchoring feet and the artificial aortic valve prosthesis, forming the first anchoring state; after the artificial aortic valve prosthesis expands, it closely adheres to the annulus stent and the aortic annulus, forming the second anchoring state; these two anchoring states provide a stable and reliable supporting effect for the artificial aortic valve, making it possible to perform transcatheter aortic valve replacement for patients with simple aortic valve regurgitation without calcification and lacking anchoring.

[0053] In addition, the beneficial effects of the anchoring device and the transcatheter artificial aortic valve system of the present application are also reflected in the following aspects:

[0054] (1) Minimally invasive implantation. The overall structure of the anchoring device of the present application is streamlined and can be compressed and loaded into a smaller-sized delivery sheath, making it easy to be implanted through the femoral artery approach.

[0055] (2) Active and accurate positioning. The anchoring feet of the anchoring device of the present application are evenly distributed around the anchoring annulus stent. The arc-shaped anchoring feet have a certain function of autonomously finding the sinus bottom. After the anchoring device is sent into the aortic root through the delivery sheath and released after appropriate adjustment for general positioning, it will actively and accurately embed into the bottom of the aortic sinus in the aortic root; the radiopaque anchoring feet also provide reference and guarantee for the accurate positioning of the subsequent implantation of the artificial aortic valve prosthesis.

[0056] (3) Facilitate subsequent transcatheter aortic valve replacement. The anchoring annulus stent of the anchoring device of the present application has a large expansion potential and can be suitable for aortic annulus dilation and ascending aorta dilation lesions of different degrees, and can match more different models of artificial aortic valve prostheses.

[0057] (4) High safety. During and after the release process of the anchoring device of the present application, it does not affect the function of the native aortic valve, will not flip, and does not affect coronary blood flow; it will not fall off into the left ventricular outflow tract and the left ventricle and does not affect the conduction system; both the distal and proximal ends are arc-shaped structures, which will not damage blood vessels and the heart, with high safety.

[0058] (5) Optimize the surgical method. After the anchoring device of the present application is implanted, it can replace the first valve in the "sandwich" surgical method, providing a safer and lower-cost first valve for support in the current "valve-in-valve" implantation method for simple aortic valve regurgitation, that is, the "sandwich" surgical method, and reducing the risks such as coronary artery occlusion and conduction block caused by valve-in-valve implantation.

[0059] (6) Facilitate the full life cycle management of patients. After the anchoring device of the present application is implanted, a shorter artificial aortic valve prosthesis can be implanted with the support of stable and reliable dual anchoring forces. For patients with a longer survival rate, it is beneficial for re-aortic valve implantation (ViV) after valve deterioration.

[0060] (7) Can be industrially produced. The overall structure of the anchoring device of the present application is streamlined and has no welding points. It can be formed by winding, laser engraving or 3D printing with a shape memory metal wire such as nitinol. Industrial mass production can also ensure stable quality and effectively avoid the uneven quality of the stent caused by temperature changes such as welding.

[0061] It should be noted that in this article, the term "including", "comprising" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements not only includes those elements, but also includes other elements not expressly listed, or further includes elements inherent to such process, method, article or device. Without further limitation, an element defined by the statement "including a..." does not exclude the existence of additional identical elements in the process, method, article or device including that element.

[0062] The above is only the specific implementation manner of the present application, but the protection scope of the present application is not limited thereto. Any person skilled in the art within the technical scope disclosed by the present application can easily think of changes or substitutions, which should all be covered within the protection scope of the present application. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.

Claims

1. An anchoring device, characterized in that: The anchoring device (100) is an integrated structure and includes an anchoring valve ring bracket (10) at the distal end and an anchoring foot (20) at the proximal end; the anchoring valve ring bracket (10) is a cylindrical mesh structure; there are three anchoring feet (20) distributed on the outer periphery of the proximal end of the anchoring valve ring bracket (10), and the anchoring feet (20) have an abduction angle relative to the axis of the anchoring valve ring bracket (10), and each of the anchoring feet (20) is a C-shaped hollow structure.

2. The anchoring device according to claim 1, characterized in that: Each of the anchoring legs (20) comprises a connecting section (21) and an arc section (22), wherein the connecting section (21) is arranged at both ends of the arc section (22) and is connected to the proximal end of the anchoring valve ring support (10).

3. The anchoring device according to claim 2, characterized in that: The anchoring valve ring bracket (10) comprises an axial section (11), a crest section (12) and a trough section (13), wherein the plurality of axial sections (11) are arranged around the axis in a direction parallel to the axis of the anchoring valve ring bracket (10), wherein the crest section (12) arc-shapedly connects the proximal ends of two adjacent axial sections (11), and the trough section (13) arc-shapedly connects the distal ends of two adjacent axial sections (11), so that the anchoring valve ring bracket (10) is in the shape of a metal wire moving back and forth in a direction parallel to the axis and connected end to end.

4. The anchoring device according to claim 3, characterized in that: The connecting section (21) extends from the proximal end of the axial section (11), and the arc section (22) connects two adjacent connecting sections (21) in a curved line, with the proximal end expanding outward.

5. The anchoring device according to claim 4, characterized in that: The outward angle of the plane where the arc segment (22) is located relative to the axial direction of the anchoring valve ring support (10) is between 25° and 40°.

6. The anchoring device according to claim 1, characterized in that: The anchoring valve ring support (10) has an axial length of 2 to 20 mm and a diameter of 24 to 40 mm.

7. The anchoring device according to claim 1, characterized in that: The radial length of the anchoring foot (20) is 10 to 25 mm.

8. The anchoring device according to claim 1, characterized in that: The distal end of the anchoring valve ring support (10) is provided with three fixing rings (30) corresponding to the interconnected positions of the three anchoring legs (20).

9. A transcatheter artificial aortic valve system, characterized in that: It comprises an anchoring device (100) according to any one of claims 1 to 8, a delivery sheath (200) and an artificial aortic valve, wherein the anchoring device (100) can be transformed between a first form and a second form; the first form is the working form of the anchoring device (100) after being implanted in the root of the human aorta, and the second form is the form of the anchoring device (100) being compressed and loaded into the delivery sheath (200).

10. The transcatheter aortic valve prosthesis system according to claim 9, characterized in that: The diameter of the anchoring valve ring support (10) is less than or equal to the diameter of the artificial aortic valve.

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