Recoverable double anchoring valve device

Abstract

The invention relates to the technical field of medical instruments, in particular to a recoverable double anchoring valve device which comprises an outer-layer support, an inner-layer support and an artificial valve, the artificial valve is arranged on the inner side of the inner-layer support, and the outer-layer support is connected to the periphery of the inner-layer support in a sleeving mode; a plurality of buffer connecting rods are connected between the inner-layer bracket and the outer-layer bracket; a first barb assembly and a second barb assembly are arranged on the outer side of the outer layer support in the circumferential direction. The first barb assemblies and the second barb assemblies are arranged in a staggered mode. A first barb assembly, a second barb assembly and a third barb assembly are annularly arranged on the outer-layer bracket; a plurality of outer locking claws are annularly arranged at the lower end of the outer-layer bracket at equal intervals; a plurality of inner locking claws are annularly arranged at the lower end of the inner-layer support at equal intervals. The device is novel in structure, and the anchoring stability between the device and the valve is improved; in addition, the buffer connecting rod is connected between the inner-layer stent and the outer-layer stent, so that deformation of the inner-layer stent is avoided, and recovery and release are facilitated.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a recyclable double-anchored valve device. Background Art

[0002] In order to solve the problem of LVOT (left ventricular outflow tract) obstruction, existing artificial valves simply shorten the valve frame structure, which will sacrifice the reliability of anchoring. Although a longer valve will affect LVOT obstruction, its length can better ensure the coaxiality of the implant. If a shorter artificial valve is implanted, once the positioning angle is deflected, the coaxiality cannot be guaranteed, and the valve may be easily displaced and flipped, which is not conducive to the treatment effect. In addition, the current outer stent and inner stent are not easy to be fully pre-released and fully recyclable. In order to solve the problems of poor coaxiality, inaccurate positioning and inconvenience of complete recyclability of short valves, a recyclable valve device with better anchoring effect is urgently needed. Summary of the invention

[0003] In view of the problems in the prior art, the present invention provides a recyclable double-anchored valve device with a novel structure, which improves the stability of the anchoring between the valve and ensures that the valve will not fall off or shift or flip. In addition, a buffer connecting rod is connected between the inner layer stent and the outer layer stent to buffer the connection between the inner layer stent and the outer layer, avoiding compression of the inner layer stent and deformation, and facilitating recovery and release.

[0004] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0005] The present invention provides a recyclable double anchor valve device, which comprises an outer stent, an inner stent and an artificial valve, wherein the artificial valve is arranged on the inner side of the inner stent, and the outer stent is sleeved on the outer periphery of the inner stent; a plurality of buffer connecting rods are connected between the inner stent and the outer stent;

[0006] The outer circumference of the outer layer stent is provided with a first barb assembly and a second barb assembly, the first barb assembly is located above the second barb assembly; the first barb assembly and the second barb assembly are arranged in a staggered manner; the first barb assembly is used to pierce the valve ring; the second barb assembly is used to pierce the valve ring or the valve leaflet;

[0007] The outer stent ring is provided with a first barb assembly, a second barb assembly and a third barb assembly; the first barb assembly, the second barb assembly and the third barb assembly are arranged sequentially from top to bottom; the first barb assembly is used to hook the tendineae on both sides; the second barb assembly is used for the leaflets on both sides; the third barb assembly is used to hook the lowest position between the front and rear leaflets of the mitral valve;

[0008] The lower end of the outer layer support is provided with a plurality of outer locking claws at equal intervals; the lower end of the inner layer support is provided with a plurality of inner locking claws at equal intervals; the upper end of the inner locking claw is movably connected to the lower end of the inner layer support.

[0009] The first barb assembly includes a plurality of first barb bodies which are arranged at equal intervals around the outer periphery of the outer layer support, and the first barb bodies are bent toward the outside of the outer layer support.

[0010] Preferably, the bending angle of the first barb body is set at 85° to 95°.

[0011] The second barb assembly includes a plurality of second barb bodies which are arranged at equal intervals around the outer periphery of the outer layer support, and the second barb bodies are bent toward the outside of the outer layer support.

[0012] Preferably, the bending angle of the second barb body is set at 40° to 60°.

[0013] Wherein, the first barb assembly includes a plurality of tendon barbs, and the plurality of tendon barbs are evenly distributed on both sides of the outer periphery of the outer layer support, and the plurality of tendon barbs of the outer layer support on each side are evenly spaced and distributed in arc shapes.

[0014] Wherein, the second barb assembly includes a plurality of leaflet barbs, and the plurality of leaflet barbs are evenly distributed on both sides of the outer periphery of the outer layer stent, and the plurality of leaflet barbs of the outer layer stent on each side are evenly spaced and distributed in arc shapes.

[0015] Wherein, the third barb assembly includes a plurality of terminal barbs, and the plurality of terminal barbs are evenly distributed on both sides of the outer periphery of the outer layer support, and the plurality of terminal barbs of the outer layer support on each side are evenly spaced and distributed in arc shapes.

[0016] Wherein, both ends of the buffer connecting rod are movably connected to the outer layer support and the inner layer support through movable connecting pieces respectively.

[0017] Beneficial effects of the present invention:

[0018] The present invention has a novel structure. The first barb assembly is inserted into the valve ring, and the second barb assembly is used to make up for the valve ring or valve leaflet that the first row of barbs have not penetrated. The first barb assembly and the second barb assembly form a complementary positional relationship in the height direction and the circumferential direction, respectively, to improve the stability of anchoring with the valve; further, the first barb assembly, the second barb assembly and the third barb assembly are respectively provided to hook the chordae tendineae and the valve leaflet to ensure that the valve will not fall off or shift and flip; in addition, the buffer connecting rod is connected between the inner layer support and the outer layer support to play a role in buffering the connection between the inner layer support and the outer layer. When the ventricle contracts and the valve closes, the blood pressure The inner stent has the force to move toward the atrium, and is connected to the outer stent by a buffer connecting rod to prevent displacement, while the outer stent itself is firmly anchored to the mitral valve tissue by barbs and radial force; the buffering effect of the buffer connecting rod means that when the outer stent is deformed, the buffer connecting rod decomposes the pressure to avoid compressing the inner stent to deform; further, the angle of the inner locking claw can be adjusted at will. Under this setting, after implantation, the balloon can be expanded to ensure that there are no obstacles in the direction of blood outflow; wherein, the multiple inner locking claws of the inner stent have a certain elasticity and ductility, and become longer when subjected to tension and shortened when subjected to pressure; it is convenient to cooperate with the outer stent to bear force and enter the catheter, so as to facilitate recovery and release. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a schematic structural diagram of a recyclable double anchored valve device of the present invention.

[0020] Figure 2 This is a schematic structural diagram from another perspective of a recyclable dual-anchored valve device of the present invention.

[0021] Figure 3 It is a schematic structural diagram of the outer layer support of the present invention.

[0022] Figure 4 It is a schematic structural diagram of the inner layer support of the present invention.

[0023] Figure 5 It is a schematic structural diagram of the movable connecting member of the present invention.

[0024] Figure 6 It is a schematic structural diagram of a buffer connecting rod according to the second embodiment of the present invention.

[0025] exist Figures 1 to 6 Reference numerals in the drawings include:

[0026] 100. Artificial valve;

[0027] 1. Outer support; 2. Inner support; 3. Buffer connecting rod; 4. First barb body; 5. Second barb body; 6. Chordae barbs; 7. Leaflet barbs; 8. End barbs; 9. Outer locking claws; 10. Inner locking claws; 11. Round holes; 12. Movable connector; 13. Rotating spindle; 14. Limiting head; 15. Elastic bending part. DETAILED DESCRIPTION

[0028] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work belong to the protection scope of the present invention. It is understood that the drawings are only provided for reference and illustration, and are not used to limit the present invention. The connection relationship shown in the drawings is only for the convenience of clear description and does not limit the connection method.

[0029] It should be noted that when a component is considered to be "connected" to another component, it can be directly connected to another component, or there may be an intermediate component at the same time. Unless otherwise defined, all technical and scientific terms used in this document have the same meaning as those generally understood by technicians in the technical field of the present invention. It should also 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 a mechanical connection, an electrical connection, or the internal connection of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0030] It should also be noted that in the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention 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 cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0031] Embodiment 1

[0032] like Figures 1 to 5As shown, a recyclable double-anchored valve device comprises an outer stent 1, an inner stent 2 and an artificial valve 100, wherein the artificial valve 100 is arranged on the inner side of the inner stent 2, and the outer stent 1 is sleeved on the outer periphery of the inner stent 2; a plurality of buffer connecting rods 3 are connected between the inner stent 2 and the outer stent 1; the outer stent 1 and the inner stent 2 are deformable metal components, conventional technology; a first barb assembly and a second barb assembly are arranged outwardly on the outer periphery of the outer stent 1, and the first barb assembly is located above the second barb assembly; the first barb assembly and the second barb assembly are arranged in an alternating manner; the first barb assembly is used for Inserted into the valve ring; the second barb assembly is used to insert into the valve ring or into the valve leaflet; the outer layer support 1 ring is provided with a first hook assembly, a second hook assembly and a third hook assembly; the first hook assembly, the second hook assembly and the third hook assembly are arranged in sequence from top to bottom; the first hook assembly is used to hook the chordae tendineae on both sides; the second hook assembly is used for the valve leaflets on both sides; the third barb assembly is used to hook the lowest position between the anterior and posterior leaflets of the mitral valve; the lower end of the outer layer support 1 is evenly spaced and provided with a plurality of outer locking claws 9; wherein, the lower end of the inner layer support 2 is evenly spaced and provided with a plurality of inner locking claws 10; preferably, the number of the outer locking claws 9 and the number of the inner locking claws 10 are both six.

[0033] Specifically, the present invention has a novel structure. The first barb assembly is inserted into the valve ring, and the second barb assembly is used to make up for the valve ring or valve leaflet that the first row of barbs has not penetrated. The first barb assembly and the second barb assembly form a complementary positional relationship in the height direction and the circumferential direction, respectively, to improve the stability of anchoring with the valve; further, the first hook assembly, the second hook assembly and the third hook assembly are respectively provided to hook the chordae tendineae and the valve leaflet to ensure that the valve will not fall off or shift and flip; in addition, the buffer connecting rod 3 is connected between the inner layer support 2 and the outer layer support 1 to play a role in buffering the connection between the inner layer support 2 and the outer layer. When the ventricular contraction valve is closed, the inner layer support has a force to move toward the atrium due to blood pressure, and is connected to the outer layer support 1 through the buffer connecting rod 3 to prevent displacement, while the outer layer support 1 itself is firmly anchored to the mitral valve tissue through the barbs and radial force; the buffering effect of the buffer connecting rod 3 means that when the outer layer support 1 is deformed, the buffer connecting rod 3 The connecting rod 3 decomposes the pressure to avoid the inner stent 2 from being deformed by compression; at the same time, under the cooperation of the first barb assembly, the second barb assembly, the first hook assembly, the second hook assembly and the third hook assembly, they are firmly anchored on the mitral valve tissue by the barbs and radial force respectively, playing the role and effect of double anchoring; further, the upper end of the inner locking claw 10 is movably connected to the lower end of the inner stent 2, and further, the upper end of the inner locking claw 10 and the lower end of the inner stent 2 can be connected and bound by a polymer line or a metal wire. Under this setting, the angle of the inner locking claw 10 can be adjusted at will. Under this setting, after implantation, the balloon is expanded to ensure that there is no obstacle in the direction of blood outflow; wherein, the multiple inner locking claws 10 of the inner stent 2 have a certain elasticity and ductility, and become longer when subjected to tension and shortened when subjected to pressure; it is convenient to cooperate with the outer stent 1 to bear force to enter the catheter, that is, all ends of the outer stent are fully controlled, and all ends of the inner stent are also fully controlled, which is convenient for recovery and release.

[0034] In the embodiment of the present application, the first barb assembly includes a plurality of first barb bodies 4 arranged at equal intervals on the outer periphery of the outer layer support 1, and the first barb body 4 is bent toward the outside of the outer layer support 1. Preferably, the bending angle of the first barb body 4 is set at 85° to 95°. The second barb assembly includes a plurality of second barb bodies 5 arranged at equal intervals on the outer periphery of the outer layer support 1, and the second barb body 5 is bent toward the outside of the outer layer support 1. Preferably, the bending angle of the second barb body 5 is set at 40° to 60°.

[0035] Specifically, the first barb body 4 has a larger bending angle for piercing the valve ring, and a bending angle close to 90° can effectively avoid tearing of the valve ring and potential puncture risk of the main valve ring in the anterior valve area; the second barb body 5 is used to make up for the valve ring that the first row of barbs has not pierced or to pierce the valve leaflet. The bending angle of the second barb body 5 is smaller to reduce the impact on the valve leaflet. At the same time, the height direction is complementary to the first barb body 4, and the circumferential position is staggered and complementary to the first barb body 4.

[0036] In an embodiment of the present application, the first barb assembly includes a plurality of tendon barbs 6, and the plurality of tendon barbs 6 are evenly distributed on the outer periphery of the outer layer support 1 on two opposite sides, and the plurality of tendon barbs 6 of the outer layer support 1 on each side are evenly spaced and distributed in arc shapes; the first barb assembly is located below the second barb assembly.

[0037] In the embodiment of the present application, the second barb assembly includes a plurality of leaflet barbs 7, which are evenly distributed on the other two sides of the outer periphery of the outer stent 1, and the plurality of leaflet barbs 7 on each side of the outer stent 1 are evenly spaced and distributed in arcs. The third barb assembly includes a plurality of terminal barbs 8, which are evenly distributed on the other two sides of the outer periphery of the outer stent 1, and the plurality of terminal barbs 8 on each side of the outer stent 1 are evenly spaced and distributed in arcs.

[0038] Specifically, the terminal barb 8 and the leaflet barb 7 are arranged in an alternating manner to better hook the leaflet, and the terminal barb 8 is located below the leaflet barb 7; wherein, the width of the chordae barb 6 is relatively narrower than the width of the leaflet barb 7 and the terminal barb 8, so as to facilitate entry into the gap between the chordae; the leaflet barb 7 is higher than the terminal barb 8 and is used to hook the leaflets on both sides; the terminal barb 8 is used to hook the lowest leaflet, because the middle of the front and rear leaflets is the longest, and the height of this section is the lowest.

[0039] Furthermore, a circular hole 11 is provided at the upper end of the terminal barb 8, and the circular hole 11 can be connected to a developing metal piece for development.

[0040] In the embodiment of the present application, the two ends of the buffer connecting rod 3 are movably connected to the outer support 1 and the inner support 2 through the movable connecting piece 12, that is, the movable connecting pieces 12 at the two ends of the buffer connecting rod 3 are movably connected to the outer support 1 and the inner support 2, respectively, and a buffer space is formed between two adjacent connecting rods; preferably, the number of the buffer connecting rods 3 is three, and the three connecting rods are equidistantly arranged in a circular ring between the inner support 2 and the outer support 1, and the area formed between every two buffer connecting rods 3 and between the inner support 2 and the outer support 1 is hollow to form a buffer space, and the angle of the area is 120°, corresponding to the angle of the front valve area, and the radial force on the outer support 1 in this area is smaller, and when the outer support 1 is deformed, the connecting rods aligned with the two sides of the front valve area can rotate tangentially, thereby decomposing the external force and avoiding deformation of the inner support 2; under this setting, it can not only ensure that the deformation of the outer support 1 after implantation will not affect the inner support 2, but also the front The posterior valve area has different radial support forces, which can better adapt to the tissue of the native mitral valve ring of the human body, and at the same time ensure its uniformity when entering and exiting the catheter; since there are three buffer connecting rods 3, the area formed by the cooperation between every two connecting rods and the inner stent 2 and the outer stent 1 is hollow, forming a buffer space, that is, three buffer spaces are formed, and any buffer space is aligned with the outflow tract position, which can reduce the obstruction caused by structural interference; there is a gap between the inner stent 2 and the outer stent 1 at the outflow tract position, which can be close to the inner stent 2 when subjected to a smaller compressive force, thereby deviating to the posterior valve side and making room for Lvot; at the same time, it is easier to fit the shape of the valve ring, so as not to interfere with Lvot and not to deform the inner stent 2; further, the movable connecting member 12 includes a rotating main shaft 13 and a limiting head 14 connected to both ends of the rotating main shaft 13, and the limiting head 14 is in the shape of a mushroom head, and the surface of the limiting head 14 is smooth, which is convenient for sheathing.

[0041] Specifically, in a natural state, the inner stent 2 is in the middle of the outer stent 1, forming a concentric circle. When the outer stent 1 is squeezed and deformed in a specific direction, the movable connecting piece 12 rotates relative to the inner stent 2 and the outer stent 1 respectively, thereby causing the connecting rod to deflect and decomposing the deformation force of the outer stent 1, so that the inner stent 2 continues to maintain a circular shape and avoids deformation of the inner stent 2; ensuring its structural stability and thus strong working stability; not only can it ensure that the deformation of the outer stent after implantation will not affect the inner stent, but also the front and rear valve regions have different radial support forces, which better adapts to the tissue of the native mitral valve ring, and at the same time can ensure its uniformity when the catheter enters and exits.

[0042] Embodiment 2

[0043] In the second embodiment of the present application, Figure 6As shown, the difference from the first embodiment is that an elastic bending portion 15 is provided in the middle of the buffer connecting rod 3, and the elastic bending portion 15 allows the buffer connecting rod 3 to be stretched and then reset, and can adapt to the deformation of the outer layer support 1 without affecting the structural stability of the inner layer support 2, and at the same time has a certain radial buffer.

[0044] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Although the present invention is disclosed as a preferred embodiment as above, it is not used to limit the present invention. Any technician familiar with the profession can make some changes or modifications to equivalent embodiments of equivalent changes by using the technical contents disclosed above without departing from the scope of the technical solution of the present invention. However, any simple modification, equivalent changes and modifications made to the above embodiments according to the technology of the present invention are within the scope of the technical solution of the present invention without departing from the content of the technical solution of the present invention.

Claims

1. A retrievable double anchored valve device, characterized in that: It comprises an outer layer stent, an inner layer stent and an artificial valve, wherein the artificial valve is arranged on the inner side of the inner layer stent, and the outer layer stent is sleeved on the outer periphery of the inner layer stent; a plurality of buffer connecting rods are connected between the inner layer stent and the outer layer stent; The outer circumference of the outer layer stent is provided with a first barb assembly and a second barb assembly, the first barb assembly is located above the second barb assembly; the first barb assembly and the second barb assembly are arranged in a staggered manner; the first barb assembly is used to pierce the valve ring; the second barb assembly is used to pierce the valve ring or the valve leaflet; The outer stent ring is provided with a first barb assembly, a second barb assembly and a third barb assembly; the first barb assembly, the second barb assembly and the third barb assembly are arranged sequentially from top to bottom; the first barb assembly is used to hook the tendineae on both sides; the second barb assembly is used for the leaflets on both sides; the third barb assembly is used to hook the lowest position between the front and rear leaflets of the mitral valve; The lower end of the outer layer support is provided with a plurality of outer locking claws at equal intervals; the lower end of the inner layer support is provided with a plurality of inner locking claws at equal intervals; the upper end of the inner locking claw is movably connected to the lower end of the inner layer support.

2. A retrievable dual anchored valve device according to claim 1, characterized in that: The first barb assembly includes a plurality of first barb bodies which are arranged at equal intervals around the outer periphery of the outer layer support, and the first barb bodies are bent toward the outside of the outer layer support.

3. A retrievable dual anchored valve device according to claim 2, characterized in that: The bending angle of the first barb body is set at 85° to 95°.

4. A retrievable dual anchored valve device according to claim 1, characterized in that: The second barb assembly includes a plurality of second barb bodies which are arranged at equal intervals around the outer periphery of the outer layer support, and the second barb bodies are bent toward the outside of the outer layer support.

5. A retrievable dual anchored valve device according to claim 4, characterized in that: The bending angle of the second barb body is set at 40° to 60°.

6. A retrievable dual anchored valve device according to claim 1, characterized in that: The first barb assembly includes a plurality of tendon barbs, and the plurality of tendon barbs are evenly distributed on both sides of the outer periphery of the outer layer support, and the plurality of tendon barbs of the outer layer support on each side are evenly spaced and distributed in arc shapes.

7. A retrievable dual anchored valve device according to claim 1, characterized in that: The second barb assembly includes a plurality of leaflet barbs, and the plurality of leaflet barbs are evenly distributed on both sides of the outer periphery of the outer layer stent, and the plurality of leaflet barbs of the outer layer stent on each side are evenly spaced and distributed in arc shapes.

8. A retrievable dual anchored valve device according to claim 1, characterized in that: The third barb assembly includes a plurality of terminal barbs, and the plurality of terminal barbs are evenly distributed on both sides of the outer periphery of the outer layer support, and the plurality of terminal barbs of the outer layer support on each side are evenly spaced and distributed in arc shapes.

9. A retrievable dual anchored valve device according to claim 1, characterized in that: The two ends of the buffer connecting rod are movably connected to the outer layer bracket and the inner layer bracket through movable connecting pieces respectively.

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