Artificial heart valve device

Abstract

The invention relates to the technical field of medical instruments, in particular to an artificial heart valve device which comprises an outer-layer support, an inner-layer support and artificial valve leaflets, the artificial valve leaflets are arranged on the inner side of the inner-layer support, barb assemblies are arranged on the periphery of the outer-layer support, the outer-layer support is connected to the periphery of the inner-layer support in a sleeving mode, and the barb assemblies are arranged on the outer-layer support. A plurality of connecting rods are annularly arranged between the outer-layer support and the inner-layer support at equal intervals, rotating shaft connecting pieces are rotationally arranged at the two ends of each connecting rod respectively, the two ends of each connecting rod are movably connected with the outer-layer support and the inner-layer support through the rotating shaft connecting pieces respectively, and a buffer space is formed between every two adjacent connecting rods. Deformation of the inner-layer support can be avoided, the structural stability of the inner-layer support is guaranteed, and therefore the working stability is high; it can be guaranteed that deformation of the outer stent does not affect the inner stent after implantation, the anterior and posterior valve areas have different radial supporting force, and meanwhile uniformity can be guaranteed when a catheter enters and exits.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an artificial heart valve device. Background Art

[0002] After implantation, the current artificial mitral valve prosthesis will reduce the cross-sectional area of ​​the left ventricular outflow tract, and even cause left ventricular outflow tract obstruction in severe cases. In view of this, the current method is to ① make the stent into a D shape, with the straight edge aligned with the left ventricular outflow tract; ② soften the mesh at the outflow tract position, or delete the mesh in the outflow tract area. Although these two methods can ensure the expected effect after implantation, due to the uneven structure of the stent itself or the radial force, it will be more troublesome to enter and exit the catheter, and it will also cause greater stress in and out of the catheter, increasing the risk of damage to the material, which will affect the future fatigue effect. Summary of the invention

[0003] In view of the problems in the prior art, the present invention provides an artificial heart valve device, which avoids deformation of the inner layer stent and ensures its structural stability, thereby making it highly stable in operation; it not only ensures 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 supporting forces, which better adapts to the tissue of the native mitral valve ring, and at the same time ensures its uniformity when the catheter enters and exits.

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

[0005] The present invention provides an artificial heart valve device, which includes an outer layer stent, an inner layer stent and an artificial valve leaf, wherein the artificial valve leaf is arranged on the inner side of the inner layer stent, a barb assembly is arranged on the outer periphery of the outer layer stent, the outer layer stent is sleeved on the outer periphery of the inner layer stent, a plurality of connecting rods are evenly spaced between the outer layer stent and the inner layer stent, and rotating shaft connecting pieces are rotatably arranged at both ends of the connecting rod, and the two ends of the connecting rod are movably connected to the outer layer stent and the inner layer stent through the rotating shaft connecting pieces, and a buffer space is formed between two adjacent connecting rods.

[0006] Wherein, a lower sealing edge is connected between the lower end of the inner layer support and the lower end of the outer layer support.

[0007] Wherein, an upper sealing edge is connected between the upper end of the inner layer support and the upper end of the outer layer support.

[0008] Wherein, a flange body is sleeved on the inner side of the upper end of the outer layer support, and a flange sealing edge is arranged on the outer wall of the flange body along its circumference.

[0009] Among them, a plurality of tree-like encryption structures are evenly distributed on the outer wall of the flange body.

[0010] Wherein, an outer support edge is arranged on the inner circumference of the outer layer support.

[0011] Wherein, the barb assembly includes a first barb group and a second barb group which are arranged circumferentially along the outer wall of the outer layer support, and the first barb group is located above the second barb group.

[0012] Among them, the first barb group includes a first barb body with multiple equally spaced rings arranged on the outer wall of the outer layer bracket, and the second barb group includes a second barb body with multiple equally spaced rings arranged on the outer wall of the outer layer bracket, and the first barb body and the second barb body are arranged in a staggered manner.

[0013] Wherein, an elastic bending portion or a connecting rotating component is provided in the middle of the connecting rod.

[0014] Among them, a plurality of locking claws are evenly spaced at the lower end of the outer layer bracket, and an escape position is provided between two adjacent locking claws. The lower ends of the locking claws are bent toward the inner side of the outer layer bracket.

[0015] Beneficial effects of the present invention:

[0016] The present invention has a novel structure and an ingenious design. The inner layer support and the outer layer support are connected by a rotating shaft connector and a connecting rod. In a natural state, the inner layer support is in the middle of the outer layer support and presents a concentric circle. When the outer layer support is squeezed and deformed in a specific direction, the rotating shaft connector rotates relative to the inner layer support and the outer layer support respectively, so that the connecting rod is deflected, and the deformation force of the outer layer support is decomposed, so that the inner layer support continues to maintain a circular shape, avoiding deformation of the inner layer support, ensuring its structural stability and thus making it highly stable at work. Not only can it ensure that the deformation of the outer layer support after implantation will not affect the inner layer support, but the front and rear valve regions have different radial supporting forces, which can better adapt to the non-uniform tissue of the native mitral valve ring and ensure its uniformity when the catheter enters and exits. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 This is a schematic structural diagram of an artificial heart valve device of the present invention from a first perspective.

[0018] Figure 2 This is a schematic structural diagram of an artificial heart valve device of the present invention from a second viewing angle.

[0019] Figure 3 This is a schematic structural diagram of an artificial heart valve device of the present invention from a third viewing angle.

[0020] Figure 4 This is a schematic structural diagram of an artificial heart valve device of the present invention from a fourth viewing angle.

[0021] Figure 5 for Figure 4 Sectional view of AA.

[0022] Figure 6 This is a schematic diagram of the structure of the outer support of Example 1 when it is subjected to stress.

[0023] Figure 7 Schematic diagram of the structure of the connecting rod of the first embodiment.

[0024] Figure 8 It is a schematic structural diagram of the rotating shaft connecting member of the first embodiment.

[0025] Fig. 9 Schematic diagram of the structure of the connecting rod of the second embodiment.

[0026] Fig.10 Schematic diagram of the structure of the connecting rod of the third embodiment.

[0027] Fig.11 Schematic diagram of the structure of the connecting rod of the fourth embodiment.

[0028] Fig.12 This is a schematic diagram of the structure of the rotating shaft connecting member of the fifth embodiment.

[0029] Fig.13 This is a schematic diagram of the structure of the rotating shaft connecting member of the sixth embodiment.

[0030] Fig.14 It is a cross-sectional view of the rotating shaft connecting member of the sixth embodiment.

[0031] exist Figures 1 to 14 Reference numerals in the drawings include:

[0032] 1. Outer support; 2. Inner support; 3. Artificial valve leaf; 4. Connecting rod; 5. Rotating shaft connector; 6. Buffer space; 7. Lower sealing edge; 8. Upper sealing edge; 9. Flange body; 10. Flange sealing edge; 11. Tree-like encryption structure; 12. Outer support edge; 13. First barb body; 14. Second barb body; 15. Locking claw; 16. Avoidance position; 17. Elastic bending part; 18. Upper section; 19. Middle section; 20. Lower section; 21. Upper rotating shaft body; 22. Lower rotating shaft body; 23. Upper limit protrusion; 24. Lower limit protrusion; 25. Rod body; 26. Wave crest; 27. Wave trough; 28. Binding line; 29. ​​Left connecting part; 30. Right connecting part; 31. Rotating main shaft; 32. Limiting head. DETAILED DESCRIPTION

[0033] 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.

[0034] 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.

[0035] 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.

[0036] Embodiment 1

[0037] like Figures 1 to 8As shown, an artificial heart valve device comprises an outer layer support 1, an inner layer support 2 and an artificial valve leaf 3, wherein the artificial valve leaf 3 is arranged on the inner side of the inner layer support 2, and a barb assembly is arranged on the outer periphery of the outer layer support 1, and the outer layer support 1 is sleeved on the outer periphery of the inner layer support 2, and a plurality of connecting rods 4 are evenly spaced between the outer layer support 1 and the inner layer support 2, and a rotating shaft connector 5 is rotatably arranged at both ends of the connecting rod 4, and the two ends of the connecting rod 4 are movably connected to the outer layer support 1 and the inner layer support 2 through the rotating shaft connector 5, that is, the rotating shaft connectors 5 at both ends of the connecting rod 4 are movably connected to the outer layer support 1 and the inner layer support 2, respectively, and a buffer space 6 is formed between two adjacent connecting rods 4. Specifically, the present invention has a novel structure and an ingenious design. The inner layer support 2 and the outer layer support 1 are connected by a rotating shaft connector 5 and a connecting rod 4. In a natural state, the inner layer support 2 is in the middle of the outer layer support 1 and presents a concentric circle. When the outer layer support 1 is squeezed and deformed in a specific direction, the rotating shaft connector 5 rotates relative to the inner layer support 2 and the outer layer support 1 respectively, so that the connecting rod 4 is deflected, and the deformation force of the outer layer support 1 is decomposed, so that the inner layer support 2 continues to maintain a circular shape, avoiding deformation of the inner layer support 2, ensuring its structural stability and thus making it highly stable at work. Not only can it ensure that the deformation of the outer support after implantation will not affect the inner support, but the front and rear valve regions have different radial supporting forces, which can better adapt to the non-uniform tissue of the native mitral valve ring (the front valve region is soft and the rear valve region is hard), and at the same time its uniformity can be ensured when the catheter enters and exits.

[0038] In the embodiment of the present application, preferably, the number of connecting rods 4 is three, and the three connecting rods 4 are evenly distributed between the inner stent 2 and the outer stent 1 in an equidistant circle, and the area formed between every two connecting rods 4 and between the inner stent 2 and the outer stent 1 is hollow, forming a buffer space 6, and the angle of this area is 120°, corresponding to the angle of the front lobe area, and the radial force exerted on the outer stent 1 in this area is smaller, and when the outer stent 1 is deformed, the connecting rods 4 aligned with the two sides of the front lobe area can rotate tangentially, thereby decomposing the external force and avoiding deformation of the inner stent 2; under this setting, not only can it be ensured that the deformation of the outer stent 1 after implantation will not affect the inner stent 2, but also the front and rear lobe areas have different radial support The supporting force can better adapt to the tissue of the native mitral valve ring of the human body, and at the same time, its uniformity can be ensured when the catheter enters and exits; since there are three connecting rods 4, the area formed by the cooperation between every two connecting rods 4 and the inner stent 2 and the outer stent 1 is hollow, forming a buffer space 6, that is, three buffer spaces 6 are formed, and any buffer space 6 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 to make room for the LVOT; at the same time, it is easier to fit the shape of the valve ring, so as not to interfere with the LVOT and not to deform the inner stent 2.

[0039] Furthermore, the number of connecting rods 4 may be a multiple of three to ensure stable insertion into the sheath, and a hollow buffer space 6 is formed between the inner layer stent 2 and the outer layer stent 1 in the front lobe area.

[0040] like Figure 6 As shown, it is a schematic diagram of the state of the outer layer stent 1 when it is subjected to force. When the external force F squeezes and deforms the outer layer stent 1, one end of the hollow buffer space 6 is aligned with the left ventricular outflow tract, namely, area A (front valve area); the area P (back valve area) in the figure is supported by the connecting rod 4, and the area A is the hollow buffer space 6. The purpose of this design is to make the front valve area easier to deform so as to fit the original D-shaped structure of the human body, and the front valve is relatively soft, and the corresponding area of ​​the outer layer stent 1 is also relatively soft; at the same time, after deformation, the outer layer stent 1 as a whole moves closer to the back valve area, thereby more effectively ensuring that the outflow tract is not obstructed.

[0041] In the embodiment of the present application, the rotating shaft connector 5 includes a rotating main shaft 31 and a limiting head 32 connected to both ends of the rotating main shaft 31. The limiting head 32 is in the shape of a mushroom head and has a smooth surface for easy insertion into the sheath.

[0042] In the embodiment of the present application, a lower sealing edge 7 is connected between the lower end of the inner layer support 2 and the lower end of the outer layer support 1, wherein an upper sealing edge 8 is connected between the upper end of the inner layer support 2 and the upper end of the outer layer support 1. Specifically, under this action, the valve can be sealed to prevent blood from passing through and thrombus accumulation.

[0043] In the embodiment of the present application, a flange body 9 is also sleeved on the inner side of the upper end of the outer layer support 1, and a flange sealing edge 10 is provided along the circumference of the outer wall of the flange body 9. Specifically, the flange body 9 can be used to seal when suturing materials, and further, the flange sealing edge 10 is provided to prevent peripheral leakage of the valve.

[0044] In the embodiment of the present application, a plurality of tree-like encryption structures 11 are evenly distributed on the outer wall of the flange body 9. Specifically, the tree-like encryption structures 11 are used to encrypt the periphery of the flange body 9 to reduce / prevent valve periphery leakage.

[0045] In the embodiment of the present application, an outer stent edge 12 is provided on the inner circumference of the outer stent 1. Specifically, it plays a role in preventing the peripheral leakage of the valve.

[0046] In the embodiment of the present application, the barb assembly includes a first barb group and a second barb group arranged circumferentially along the outer wall of the outer layer stent 1, and the first barb group is located above the second barb group. Wherein, the first barb group includes a first barb body 13 with a plurality of equally spaced rings arranged on the outer wall of the outer layer stent 1, and the second barb group includes a second barb body 14 with a plurality of equally spaced rings arranged on the outer wall of the outer layer stent 1, and the first barb body 13 and the second barb body 14 are arranged in a mutually staggered manner. Specifically, under the above arrangement, a height difference is formed between the first barb body 13 and the second barb body 14, the first barb body 13 is used to anchor on the native valve ring of the human body, and the second barb body 14 is used to anchor on the native valve leaflet of the human body. Further, according to actual needs, the bending angle and length of the first barb body 13 and the second barb body 14 are differentiated to ensure good anchoring on the native valve ring and valve leaflet.

[0047] In the embodiment of the present application, the lower end of the outer stent 1 is provided with a plurality of locking claws 15 at equal intervals, and an avoidance position 16 is provided between two adjacent locking claws 15; wherein, the lower end of the locking claw 15 is bent toward the inner side of the outer stent 1. Specifically, the locking claw 15 can be used to connect with the conveyor to facilitate a series of operations such as sheathing, releasing, implanting anchoring, and unlocking of the artificial valve device; wherein, the avoidance position 16 is located between the two locking claws 15, and the grid of the vacant area is concave inwardly in the radial direction of the outer stent 1 to reduce interference with the ventricular wall and the leaflets, and aligning the avoidance position 16 with the LVOT (left ventricular outflow tract) can effectively avoid LVOT obstruction.

[0048] Embodiment 2

[0049] In the second embodiment of the present application, Fig. 9 As shown, the difference from the first embodiment is that an elastic bending portion 17 is provided in the middle of the connecting rod 4, and the elastic bending portion 17 allows the connecting rod 4 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.

[0050] Embodiment 3

[0051] In the third embodiment of the present application, Fig.10 As shown, the difference from Example 1 is that: the connecting rod 4 includes an upper section 18, a middle section 19 and a lower section 20, the upper end of the upper section 18 is rotatably connected to the shaft connecting member 5 and is movably connected to the inner layer bracket 2 through the shaft connecting member 5, the lower end of the upper section 18 is rotatably connected to the upper end of the middle section 19 through an upper shaft body 21, the lower end of the middle section 19 is rotatably connected to the upper end of the lower section 20 through a lower shaft body 22, and the lower end of the lower section 20 is rotatably connected to the shaft connecting member 5 and is movably connected to the outer layer bracket 1 through the shaft connecting member 5. Specifically, under the above-mentioned setting, when the connecting rod 4 is subjected to force, the middle section 19 rotates inwardly along the radial direction of the outer layer bracket 1, thereby reducing the gap between the inner layer bracket 2 and the outer layer bracket 1, and ensuring that the deformation force of the outer layer bracket 1 does not directly act on the inner layer bracket 2, thereby avoiding causing deformation of the inner layer bracket 2; wherein, the middle section 19, the upper rotating shaft body 21, and the lower rotating shaft body 22 form the connecting and rotating assembly of the embodiment of the present application.

[0052] Furthermore, an upper limit protrusion 23 abutting against an upper end side of the middle section 19 is provided on the lower end side of the upper section 18, and a lower limit protrusion 24 abutting against a lower end side of the middle section 19 is provided on the upper end side of the lower section 20. Under the action of the upper limit protrusion 23 and the lower limit protrusion 24, it is ensured that the middle section 19 cannot continue to rotate after rotating to a certain angle, which can effectively prevent the connecting rod 4 from excessively rotating and causing knotting and being unable to rebound to the original position, thereby avoiding affecting the overall function of the outer layer bracket 1 and the inner layer bracket 2.

[0053] Embodiment 4

[0054] In the fourth embodiment of the present application, Fig.11 As shown, the difference from the first embodiment is that: a plurality of connecting rods 4 are integrally connected and form a wave ring structure; a plurality of rod bodies 25 are protruded from the inner and outer sides of the wave ring structure respectively to connect with the inner support 2 and the outer support 1, and the wave ring structure is provided with a plurality of wave peaks 26 and wave troughs 27, which can play a buffering role.

[0055] Embodiment 5

[0056] In the fifth embodiment of the present application, Fig.12 As shown, the difference from Example 1 is that the shaft connector 5 is a binding wire 28 or a bundled metal wire, and the binding wire 28 can be knotted or the metal wire can be bundled to ensure that the connection between the shaft connector 5 and the inner layer bracket 2 and the outer layer bracket 1 has a smaller range of freedom, which can achieve better buffering and also play a supporting role.

[0057] Embodiment 6

[0058] In Example 6 of the present application, Figure 13 to Figure 14 As shown, the difference from the first embodiment is that the shaft connector 5 includes a left connecting portion 29 and a right connecting portion 30, and the left connecting portion 29 and the right connecting portion 30 are detachably connected and can be achieved by threaded connection, which is convenient for assembly and disassembly.

[0059] 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. An artificial heart valve device, characterized in that: It includes an outer layer support, an inner layer support and an artificial valve leaf, the artificial valve leaf is arranged on the inner side of the inner layer support, the outer layer support is provided with a barb assembly at its periphery, the outer layer support is sleeved on the outer periphery of the inner layer support, a plurality of connecting rods are evenly spaced between the outer layer support and the inner layer support, both ends of the connecting rod are rotatably provided with a rotating shaft connecting piece, the two ends of the connecting rod are movably connected to the outer layer support and the inner layer support through the rotating shaft connecting piece, and a buffer space is formed between two adjacent connecting rods.

2. An artificial heart valve device according to claim 1, characterized in that: A lower sealing edge is connected between the lower end of the inner layer support and the lower end of the outer layer support.

3. An artificial heart valve device according to claim 1, characterized in that: An upper sealing edge is connected between the upper end of the inner layer support and the upper end of the outer layer support.

4. The artificial heart valve device according to claim 1, characterized in that: A flange body is sleeved on the inner side of the upper end of the outer layer support, and a flange sealing edge is arranged on the outer wall of the flange body along its circumference.

5. An artificial heart valve device according to claim 4, characterized in that: The outer wall of the flange body is evenly distributed with a plurality of tree-like encryption structures.

6. The artificial heart valve device according to claim 1, characterized in that: An outer support edge is arranged on the inner circumference of the outer layer support.

7. The artificial heart valve device according to claim 1, characterized in that: The barb assembly comprises a first barb group and a second barb group which are arranged circumferentially along the outer wall of the outer layer support, wherein the first barb group is located above the second barb group.

8. An artificial heart valve device according to claim 7, characterized in that: The first barb group includes a first barb body with multiple equally spaced rings arranged on the outer wall of the outer layer support, and the second barb group includes a second barb body with multiple equally spaced rings arranged on the outer wall of the outer layer support. The first barb body and the second barb body are arranged in a staggered manner.

9. The artificial heart valve device according to claim 1, characterized in that: The middle part of the connecting rod is provided with an elastic bending part or a connecting rotating component.

10. The artificial heart valve device according to claim 1, characterized in that: The lower end of the outer layer support is provided with a plurality of locking claws at equal intervals, and an escape position is provided between two adjacent locking claws; the lower end of the locking claw is bent toward the inner side of the outer layer support.

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