Valve device with double anchoring function

Abstract

The utility model relates to the technical field of medical instruments, in particular to a valve device with double anchoring, 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 sleeved on the periphery of the inner-layer support. 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; the first barb assembly, the second barb assembly and the third barb assembly are sequentially arranged from top to bottom. The valve anchor is novel in structure, and stability of anchoring between the valve anchor and the valve is improved; the valve is ensured not to fall off or shift and turn over; in addition, the buffer connecting rod is connected between the inner-layer support and the outer-layer support, so that the inner-layer support is prevented from being pressed to deform.

Description

Technical Field

[0001] This utility model relates to the technical field of medical devices, and in particular to a valve device with dual anchoring. Background Technology

[0002] Existing artificial valves, in order to solve LVOT (left ventricular outflow tract) obstruction, simply shorten the valve frame structure. This sacrifices the reliability of anchoring. Although longer valves may affect LVOT obstruction, their length can better ensure the coaxiality of implantation. If a shorter artificial valve is implanted, once the positioning angle is deviated, the coaxiality cannot be guaranteed, and the valve is prone to displacement and overturning, causing terrible consequences. In order to solve the problems of poor release coaxiality and inaccurate positioning of short valves, there is an urgent need for a valve device with better anchoring effect. Summary of the Invention

[0003] This invention addresses the problems in the prior art by providing a valve device with dual anchoring. The novel structure improves the stability of the anchoring with the valve, ensuring that the valve will not detach or shift and flip. In addition, a buffer connecting rod connects the inner and outer stents, which acts as a buffer between the inner and outer stents, preventing the inner stent from being compressed and deformed.

[0004] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:

[0005] This utility model provides a valve device with dual anchoring, which includes an outer support, an inner support, and an artificial valve. The artificial valve is disposed inside the inner support, and the outer support is sleeved on the outer periphery of the inner support. Multiple buffer connecting rods are connected between the inner support and the outer support.

[0006] The outer support has a first barb assembly and a second barb assembly arranged outward from its outer periphery, with the first barb assembly 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 to insert into the valve annulus; the second barb assembly is used to insert into the valve annulus or into the valve leaflet.

[0007] The outer support 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 chordae 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 in the middle of the anterior and posterior leaflets of the mitral valve.

[0008] The first barb assembly includes a plurality of equally spaced first barb bodies arranged in a ring around the outer periphery of the outer support, the first barb bodies being bent outward toward the outer side of the outer support.

[0009] Preferably, the bending angle of the first barb body is set at 85° to 95°.

[0010] The second barb assembly includes a plurality of equally spaced second barb bodies arranged in a ring around the outer periphery of the outer support, the second barb bodies being bent outward toward the outer side of the outer support.

[0011] Preferably, the bending angle of the second barb body is set at 40° to 60°.

[0012] The first barb assembly includes multiple tendon barbs, which are evenly distributed on both sides of the outer periphery of the outer support, and the multiple tendon barbs on each side of the outer support are distributed in an equally spaced arc shape.

[0013] The second barb assembly includes multiple leaflet barbs, which are evenly distributed on both sides of the outer periphery of the outer support. The multiple leaflet barbs on each side of the outer support are distributed in an equally spaced arc shape.

[0014] The third barb assembly includes multiple end barbs, which are evenly distributed on both sides of the outer periphery of the outer support. The multiple end barbs on each side of the outer support are distributed in an equally spaced arc shape.

[0015] The lower end of the outer support is provided with multiple external locking claws at equal intervals.

[0016] The lower end of the inner support is provided with multiple inner locking claws at equal intervals.

[0017] The beneficial effects of this utility model are:

[0018] This utility model features a novel structure. A first barb assembly is inserted into the valve annulus, and a second barb assembly is used to compensate for any gaps in the first row of barbs that are not embedded in the annulus or leaflets. The first and second barb assemblies are complementary in both height and circumferential directions, improving the stability of the anchorage with the valve. Furthermore, a first, second, and third hook assembly are provided to hook the chordae tendineae and leaflets, ensuring the valve does not detach, shift, or overturn. Additionally, a buffer connecting rod connects the inner and outer stent layers, providing a buffer between them. When the ventricle contracts and the valve closes, the inner stent, under blood pressure, experiences a force that pushes it towards the atrium. This force is prevented by the buffer connecting rod connecting it to the outer stent, while the outer stent itself is firmly anchored to the mitral valve tissue through the barbs and radial force. The buffering effect of the connecting rod means that when the outer stent deforms, the connecting rod distributes the pressure, preventing the inner stent from deforming. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the structure of a valve device with dual anchoring according to the present invention.

[0020] Figure 2 This is a schematic diagram of another perspective of the valve device with dual anchoring according to the present invention.

[0021] Figure 3 This is a schematic diagram of the outer support structure of this utility model.

[0022] Figure 4 This is a schematic diagram of the inner support structure of this utility model.

[0023] Figure 5 This is a structural schematic diagram of the movable connector of this utility model.

[0024] Figure 6 This is a schematic diagram of the buffer connecting rod in Embodiment 2 of this utility model.

[0025] exist Figures 1 to 6 The reference numerals in the figures include:

[0026] 100. Artificial valves;

[0027] 1. Outer support; 2. Inner support; 3. Buffer connecting rod; 4. First barb body; 5. Second barb body; 6. Tendon barb; 7. Leaflet barb; 8. End barb; 9. Outer locking claw; 10. Inner locking claw; 11. Round hole; 12. Movable connector; 13. Rotating spindle; 14. Limiting head; 15. Elastic bending part. Detailed Implementation

[0028] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present utility model, not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present utility model without creative effort are within the protection scope of the present utility model. It is understood that the accompanying drawings are provided for reference and illustration only and are not intended to limit the present utility model. The connection relationships shown in the drawings are only for clear description and do 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 the other component, or there may be an intervening component. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. It should also be noted that, unless otherwise expressly specified and limited, the terms "installed," "connected," and "linked" should be interpreted broadly, for example, as a fixed connection, a detachable connection, or an integral connection; as a mechanical connection or an electrical connection; or as a connection within two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. The terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to limit the invention.

[0030] It should also be noted that in the description of this utility model, the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0031] Example 1

[0032] like Figures 1 to 5 As shown, a valve device with dual anchoring includes an outer support 1, an inner support 2, and an artificial valve 100. The artificial valve 100 is disposed inside the inner support 2, and the outer support 1 is sleeved on the outer periphery of the inner support 2. Multiple buffer connecting rods 3 connect the inner support 2 and the outer support 1. The outer support 1 and the inner support 2 are deformable metal components, using conventional technology. A first barb assembly and a second barb assembly are disposed outwardly on the outer periphery of the outer support 1, with the first barb assembly located behind the second barb assembly. Above; the first barb assembly and the second barb assembly are staggered; the first barb assembly is used to pierce the valve annulus; the second barb assembly is used to pierce the valve annulus or the valve leaflet; the outer support 1 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 chordae tendineae on both sides; the second barb assembly is used for the valve leaflets on both sides; the third barb assembly is used to hook the lowest position in the middle of the anterior and posterior leaflets of the mitral valve.

[0033] Specifically, this utility model features a novel structure. A first barb assembly is inserted into the valve annulus, and a second barb assembly is used to compensate for any gaps in the valve annulus or leaflets where the first row of barbs has not penetrated. The first and second barb assemblies are complementary in both the height and circumferential directions, improving the stability of the anchoring with the valve. Furthermore, a first, second, and third barb assembly are respectively provided to hook the chordae tendineae and leaflets, ensuring that the valve will not detach or shift / overturn. Additionally, a buffer connecting rod 3 connects the inner support 2 and the outer support 1, providing a buffer for the connection between the inner and outer support layers. The function of the inner stent is that when the ventricular systolic valve closes, the pressure from the blood flow causes the inner stent to move towards the atrium. This movement is prevented by connecting the inner stent to the outer stent 1 via the buffer connecting rod 3. The outer stent 1 itself is firmly anchored to the mitral valve tissue by barbs and radial force. The buffering effect of the buffer connecting rod 3 is that when the outer stent 1 deforms, the buffer connecting rod 3 decomposes the pressure, preventing the inner stent 2 from deforming. At the same time, with the cooperation of the first barb assembly, the second barb assembly, the first barb assembly, the second barb assembly, and the third barb assembly, the inner stent is firmly anchored to the mitral valve tissue by barbs and radial force, achieving a dual anchoring function and effect.

[0034] In this embodiment, the first barb assembly includes a plurality of equally spaced first barb bodies 4 arranged in a ring around the outer periphery of the outer support 1, the first barb bodies 4 being bent outwards from the outer support 1. Preferably, the bending angle of the first barb bodies 4 is set to 85° to 95°. The second barb assembly includes a plurality of equally spaced second barb bodies 5 arranged in a ring around the outer periphery of the outer support 1, the second barb bodies 5 being bent outwards from the outer support 1. Preferably, the bending angle of the second barb bodies 5 is set to 40° to 60°.

[0035] Specifically, the first barb body 4 has a large bending angle for inserting into the valve annulus. At the same time, the bending angle of nearly 90° can effectively avoid tearing the valve annulus and also avoid the potential risk of puncturing the main valve annulus in the anterior valve region. The second barb body 5 is used to compensate for the valve annulus that the first row of barbs has not inserted into or to insert into the valve leaflet. The bending angle of the second barb body 5 is smaller, reducing the impact on the valve leaflet. At the same time, its height direction is complementary to the first barb body 4, and its circumferential position is staggered and complementary to the first barb body 4.

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

[0037] In this embodiment, the second barb assembly includes a plurality of leaflet barbs 7, which are evenly distributed on the other two opposite sides of the outer periphery of the outer support 1, with the leaflet barbs 7 on each side of the outer support 1 arranged in an equally spaced arc shape. The third barb assembly includes a plurality of end barbs 8, which are evenly distributed on the other two opposite sides of the outer periphery of the outer support 1, with the end barbs 8 on each side of the outer support 1 arranged in an equally spaced arc shape.

[0038] Specifically, the terminal barb 8 and the leaflet barb 7 are arranged in an alternating pattern to better hook the leaflets, with the terminal barb 8 located below the leaflet barb 7. The width of the chordae tendineae barb 6 is relatively narrower than the width of the leaflet barb 7 and the terminal barb 8, making it easier to enter the gap between the chordae tendineae. 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 section between the front and rear leaflets is the longest and has the lowest height.

[0039] Furthermore, the upper end of the end barb 8 is provided with a round hole 11, which can be used to tie and connect the developing metal part for developing.

[0040] In this embodiment, the lower end of the outer stent 1 is provided with a plurality of external locking claws 9 at equal intervals; wherein, the lower end of the inner stent 2 is provided with a plurality of internal locking claws 10 at equal intervals; preferably, the number of both external locking claws 9 and internal locking claws 10 is six. Specifically, the upper end of the internal locking claw 10 is movably connected to the lower end of the inner stent 2. Further, the upper end of the internal locking claw 10 and the lower end of the inner stent 2 can be connected and bound by polymer thread or metal wire. With this setting, the angle of the internal locking claw 10 can be adjusted at will. With this setting, after implantation, balloon dilation ensures that there are no obstructions in the direction of blood outflow. The plurality of internal locking claws 10 of the inner stent 2 have a certain degree of elasticity and extensibility, becoming longer under tension and shorter under pressure; facilitating their cooperation with the outer stent 1 in receiving force and entering the catheter.

[0041] In this embodiment, the two ends of the buffer connecting rod 3 are movably connected to the outer support 1 and the inner support 2 respectively through the movable connecting member 12. That is, the movable connecting members 12 at both 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, there are three buffer connecting rods 3, which are arranged in an evenly spaced circular ring between the inner support 2 and the outer support 1. The area formed between every two buffer connecting rods 3 and the inner support 2 and the outer support 1 is hollow, forming a buffer space. The angle of this area is 120°, corresponding to the angle of the anterior flap area. The radial force on the outer support 1 in this area is smaller, and when the outer support 1 deforms, the connecting rods on both sides of the anterior flap area can rotate tangentially, thereby dispersing the external force and preventing the inner support 2 from deforming. With this setting, it can be ensured that the deformation of the outer support 1 after implantation will not affect the inner support 2, and the anterior flap area will be more stable. The posterior leaflet region has different radial support forces, which better adapts to the tissue of the human mitral valve annulus and ensures its uniformity when entering and exiting the catheter. Since there are three buffer connecting rods 3, the area formed between each pair of connecting rods and between the inner support 2 and the outer support 1 is hollow, forming a buffer space, that is, three buffer spaces are formed. Any one of the buffer spaces can be aligned with the outflow tract position to reduce obstruction caused by structural interference. There is a gap between the inner support 2 and the outer support 1 at the outflow tract position, which can bring the inner support 2 closer under less pressure, thus biasing it towards the posterior leaflet side and making room for the Lvot. At the same time, it is easier to fit the shape of the valve annulus, so as not to interfere with the Lvot and not to deform the inner support 2. Furthermore, the movable connector 12 includes a rotating main shaft 13 and limiting heads 14 connected to both ends of the rotating main shaft 13. The limiting heads 14 are mushroom-shaped and have a smooth surface for easy insertion into the sheath.

[0042] Specifically, in its natural state, the inner stent 2 is located in the middle of the outer stent 1, forming a concentric circle. When the outer stent 1 is compressed and deformed in a specific direction, the movable connector 12 rotates relative to the inner stent 2 and the outer stent 1 respectively, thereby causing the connecting rod to deflect and decompose the deformation force of the outer stent 1, so that the inner stent 2 continues to maintain its circular shape and avoids deformation of the inner stent 2; thus ensuring its structural stability and strong working stability; it not only ensures that the deformation of the outer stent after implantation will not affect the inner stent, but also that the anterior and posterior flap regions have different radial support forces, better adapting to the tissue of the original mitral valve annulus, and ensuring its uniformity when entering and exiting the catheter.

[0043] Example 2

[0044] In Embodiment 2 of this application, as Figure 6As shown, the difference from Embodiment 1 is that the buffer connecting rod 3 is provided with an elastic bending part 15 in the middle. The elastic bending part 15 allows the buffer connecting rod 3 to be stretched and reset, which can adapt to the deformation of the outer support 1 and does not affect the structural stability of the inner support 2, while also having a certain radial buffer.

[0045] The above description is merely a preferred embodiment of the present utility model and is not intended to limit the present utility model in any way. Although the present utility model has been disclosed above with reference to a preferred embodiment, it is not intended to limit the present utility model. Any person skilled in the art can make some changes or modifications to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present utility model. Any simple modifications, equivalent changes, and modifications made to the above embodiments based on the present utility model without departing from the scope of the present utility model shall fall within the scope of the present utility model.

Claims

1. A valve device with dual anchoring, characterized in that: It includes an outer stent, an inner stent, and an artificial valve. The artificial valve is disposed inside the inner stent, and the outer stent is sleeved on the outer periphery of the inner stent. Multiple buffer connecting rods connect the inner stent and the outer stent. The outer support has a first barb assembly and a second barb assembly arranged outward from its outer periphery, with the first barb assembly 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 to insert into the valve annulus; the second barb assembly is used to insert into the valve annulus or into the valve leaflet. The outer support 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 chordae 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 in the middle of the anterior and posterior leaflets of the mitral valve.

2. The valve device with dual anchoring according to claim 1, characterized in that: The first barb assembly includes a plurality of first barb bodies that are equally spaced and arranged around the outer periphery of the outer support, and the first barb bodies are bent outward toward the outer side of the outer support.

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

4. A valve device with dual anchoring according to claim 1, characterized in that: The second barb assembly includes a plurality of equally spaced second barb bodies arranged in a ring around the outer periphery of the outer support, the second barb bodies being bent outward toward the outer side of the outer support.

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

6. A valve device with dual anchoring according to claim 1, characterized in that: The first barb assembly includes multiple tendon barbs, which are evenly distributed on both sides of the outer periphery of the outer support, and the multiple tendon barbs on each side of the outer support are distributed in an equally spaced arc shape.

7. A valve device with dual anchoring according to claim 1, characterized in that: The second barb assembly includes multiple leaflet barbs, which are evenly distributed on both sides of the outer periphery of the outer support. The multiple leaflet barbs on each side of the outer support are distributed in an equally spaced arc shape.

8. A valve device with dual anchoring according to claim 1, characterized in that: The third barb assembly includes multiple end barbs, which are evenly distributed on both sides of the outer periphery of the outer support. The multiple end barbs on each side of the outer support are distributed in an equally spaced arc shape.

9. A valve device with dual anchoring according to claim 1, characterized in that: The lower end of the outer support is provided with multiple external locking claws at equal intervals.

10. A valve device with dual anchoring according to claim 1, characterized in that: The lower end of the inner support is provided with multiple inner locking claws at equal intervals.

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