Artificial heart valve device

Abstract

The utility model 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 an artificial valve leaf, the artificial valve leaf is 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 with the periphery of the inner-layer support in a sleeved 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, structural stability of the inner-layer support is guaranteed, and 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 utility model relates to medical equipment technical field especially is a kind of artificial heart valve device. BACKGROUND

[0002] Present artificial mitral valve prosthesis implantation will make left ventricular outflow tract cross-sectional area decrease, and serious even left ventricular outflow tract obstruction occurs;In view of this, the method currently used is ① the stent is made into D shape, wherein the straight line side is aligned with left ventricular outflow tract;②The grid at the outflow tract position is soft, or the grid at the outflow tract region is deleted.The two methods can ensure the desired effect after implantation, but due to the uneven structure or radial force of the stent itself, it will cause trouble when entering and exiting the catheter, and also make the stress of entering and exiting the catheter larger, increase the risk of material damage, so as to affect the future fatigue effect. SUMMARY

[0003] The utility model provides a kind of artificial heart valve device for the problems in prior art, avoid inner layer stent deformation, ensure its structure stability to make working stability strong;Not only can ensure that the deformation of outer stent after implantation does not affect inner stent, and front and rear valve area has different radial support force, better adaptation native mitral annulus tissue, while entering and exiting catheter can also ensure its uniformity.

[0004] To solve the above technical problems, the utility model adopts the following technical scheme:

[0005] The utility model provides a kind of artificial heart valve device, it includes outer layer stent, inner layer stent and artificial valve leaflet, the artificial valve leaflet is arranged at the inboard of the inner layer stent, the outer periphery of the outer layer stent is provided with barb subassembly, the outer layer stent is sleeved in the outer periphery of the inner layer stent, multiple connecting rods are arranged at equal intervals between the outer layer stent and the inner layer stent, the both ends of the connecting rod are rotatably provided with shaft connecting piece, the both ends of the connecting rod are movably connected with the outer layer stent and the inner layer stent by the shaft connecting piece, and the adjacent two connecting rods form buffer space.

[0006] Wherein, the lower end of the inner layer stent is connected with the lower end of the outer layer stent and is connected with the lower end of the outer layer stent.

[0007] Wherein, the upper end of the inner layer stent is connected with the upper end of the outer layer stent and is connected with the upper end of the outer layer stent.

[0008] Wherein, the upper end of the outer layer stent is also sleeved with flange body in the inboard, and the outer wall of the flange body is provided with flange sealing edge along its circumferential direction.

[0009] Wherein, the outer wall of the flange body is evenly distributed and provided with multiple tree encryption structures.

[0010] The inner side of the outer layer support is circumferentially provided with an outer support surrounding edge.

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

[0012] The first barb group comprises a plurality of first barb bodies circumferentially arranged on the outer wall of the outer layer support, and the second barb group comprises a plurality of second barb bodies circumferentially arranged on the outer wall of the outer layer support, and the first barb bodies and the second barb bodies are arranged in a staggered manner.

[0013] The middle part of the connecting rod is provided with an elastic bending part or a connecting rotating assembly.

[0014] The lower end of the outer layer support is circumferentially provided with a plurality of locking claws, and an empty space is arranged between adjacent two locking claws, and the lower end of the locking claw is arranged to be bent towards the inner side of the outer layer support.

[0015] The beneficial effects of the present application are as follows:

[0016] The present application has the advantages of novel structure and ingenious design, the inner layer support and the outer layer support are connected by the cooperation of the rotating shaft connecting piece and the connecting rod, in a natural state, the inner layer support is located in the middle of the outer layer support, and presents a concentric circle, when the outer layer support is extruded in a specific direction, the rotating shaft connecting piece rotates relative to the inner layer support and the outer layer support respectively, so that the connecting rod is deflected, the deformation force of the outer layer support is decomposed, so that the inner layer support continues to maintain a circular shape, avoids deformation of the inner layer support, ensures the structural stability, and makes the working stability strong; not only can ensure that the deformation of the outer support after implantation does not affect the inner support, but also the front and rear valve regions have different radial support forces, better adapt to the tissue of the original native mitral annulus, and can also ensure uniformity when the catheter is inserted and withdrawn. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1 It is a first view structure schematic view of the artificial heart valve device.

[0018] Figure 2 It is a second view structure schematic view of the artificial heart valve device.

[0019] Figure 3 It is a third view structure schematic view of the artificial heart valve device.

[0020] Figure 4 It is a fourth view structure schematic view of the artificial heart valve device.

[0021] Figure 5 Fig. 1 is a perspective view of an artificial valve according to an embodiment of the present application. Figure 4 Fig. 2 is a sectional view of A-A in Fig. 1.

[0022] Figure 6 Fig. 3 is a schematic view of the structure of the outer support of the artificial valve of Fig. 1 under stress.

[0023] Figure 7 Fig. 4 is a schematic view of the structure of the connecting rod of the artificial valve of Fig. 1.

[0024] Figure 8 Fig. 5 is a schematic view of the structure of the pivot connecting piece of the artificial valve of Fig. 1.

[0025] Figure 9 Fig. 6 is a schematic view of the structure of the connecting rod of the artificial valve of Fig. 2.

[0026] Figure 10 Fig. 7 is a schematic view of the structure of the connecting rod of the artificial valve of Fig. 3.

[0027] Figure 11 Fig. 8 is a schematic view of the structure of the connecting rod of the artificial valve of Fig. 4.

[0028] Figure 12 Fig. 9 is a schematic view of the structure of the pivot connecting piece of the artificial valve of Fig. 5.

[0029] Figure 13 Fig. 10 is a schematic view of the structure of the pivot connecting piece of the artificial valve of Fig. 6.

[0030] Figure 14 Fig. 11 is a sectional view of the pivot connecting piece of Fig. 6.

[0031] In the drawings: Figures 1 to 14 The reference numerals in the drawings include:

[0032] 1, outer support; 2, inner support; 3, artificial valve leaflet; 4, connecting rod; 5, pivot connecting piece; 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 surrounding edge; 13, first barb body; 14, second barb body; 15, locking claw; 16, clearance; 17, elastic bending portion; 18, upper section; 19, middle section; 20, lower section; 21, upper pivot body; 22, lower pivot body; 23, upper limiting protrusion; 24, lower limiting protrusion; 25, rod body; 26, wave crest; 27, wave trough; 28, binding wire; 29, left connecting portion; 30, right connecting portion; 31, rotating main shaft; 32, limiting head. DETAILED DESCRIPTION

[0033] With reference to the drawings of the embodiments of the present application, the technical solutions in the embodiments of the present application will be clearly and completely described. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments of the present application, all the other embodiments obtained by those of ordinary skill in the art without creative work belong to the protection scope of the present application. It can be understood that the drawings are only provided for reference and illustration, and are not used to limit the present application. The connection relationship shown in the drawings is only for the purpose of clear description, and does not limit the connection mode.

[0034] 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 a middle component can exist at the same time. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the present application belongs. It should be noted that, unless otherwise specified and limited, the terms "mounting", "connection", "connection" should be understood broadly, for example, it can be fixed connection, or detachable connection, or integral connection; it can be mechanical connection, or electrical connection, or the communication between two elements. For those of ordinary skill in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances. The terms used in the specification of the present application are only for the purpose of describing the specific embodiments, and are not intended to limit the present application.

[0035] It should be noted that in the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the purpose of facilitating the description of the present application and simplifying the description, and are not intended to indicate or imply that the indicated device or element must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first", "second", "third" are only for the purpose of description, and cannot be understood as indicating or implying relative importance.

[0036] Embodiment one

[0037] As Figures 1 to 8The utility model discloses a kind of artificial heart valve devices, including outer layer support 1, inner layer support 2 and artificial valve leaflet 3, the artificial valve leaflet 3 is arranged on the inside of the inner layer support 2, the outer periphery of the outer layer support 1 is provided with barb assembly, the outer layer support 1 is sleeved on the outer periphery of the inner layer support 2, multiple connecting rods 4 are arranged in multiple connecting rods 4 between the outer layer support 1 and the inner layer support 2, the both ends of the connecting rod 4 are respectively rotationally provided with shaft connecting piece 5, the both ends of the connecting rod 4 are respectively connected with the outer layer support 1 and the inner layer support 2 by the shaft connecting piece 5, i.e. the shaft connecting piece 5 of connecting rod 4 both ends is respectively connected with outer layer support 1, inner layer support 2, and the buffer space 6 is formed between the two adjacent connecting rods 4. Specifically, the utility model novel structure, ingenious design, the inner layer support 2 and outer layer support 1 are connected by shaft connecting piece 5 and connecting rod 4 cooperation, in natural state, inner layer support 2 is in the middle of outer layer support 1, presents concentric circle, when outer layer support 1 is extruded towards specific direction and deforms, shaft connecting piece 5 respectively relative to inner layer support 2, outer layer support 1 occurs rotation, so that connecting rod 4 is deflected, and the deformation force of outer layer support 1 is decomposed, so that inner layer support 2 continues to keep circular, avoid inner layer support 2 deformation, guarantee its structure stability to make the working stability strong;Not only can guarantee that the deformation of outer support after implantation does not affect inner support, and the front and rear valve area has different radial support force, better adaptation native mitral annulus tissue, simultaneously when entering and exiting catheter, can also guarantee its uniformity.

[0038] In this embodiment, preferably, there are three connecting rods 4, which are evenly distributed in a circular pattern between the inner support 2 and the outer support 1. The area formed between every two connecting rods 4 and between the inner support 2 and the outer support 1 is hollow, forming a buffer space 6. 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 4 on both sides of the anterior flap area can rotate tangentially, thereby dispersing the external force and preventing deformation of the inner support 2. With this configuration, not only can the deformation of the outer support 1 after implantation not affect the inner support 2, but the anterior and posterior flap areas also have different radial support. The support structure better adapts to the tissue of the human mitral valve annulus and ensures uniformity during catheter insertion and exit. Since there are three connecting rods 4, the area formed between each pair of connecting rods 4 and the inner stent 2 and outer stent 1 is hollow, creating a buffer space 6. This results in three buffer spaces 6, where any one of these spaces can be aligned with the outflow tract, reducing obstruction caused by structural interference. The gap between the inner stent 2 and outer stent 1 at the outflow tract allows the stent to approach the inner stent 2 with less pressure, thus shifting towards the posterior leaflet and creating space for the lvot. Simultaneously, it more easily conforms to the shape of the valve annulus, preventing interference with the lvot and deformation of the inner stent 2.

[0039] Furthermore, the number of connecting rods 4 can be a multiple of three to ensure stable sheath insertion, and a hollow buffer space 6 is formed between the inner support 2 and the outer support 1 in the anterior lobe region.

[0040] like Figure 6 The diagram shows the state of the outer support 1 under stress. When the external force F compresses and deforms the outer support 1, one end of the hollow buffer space 6 is aligned with the left ventricular outflow tract, i.e., region A (anterior lobe region). Region P (posterior lobe region) in the diagram is supported by the connecting rod 4. Region A is the hollow buffer space 6. The purpose of this design is to make the anterior lobe region more easily deformable to conform to the original D-shaped structure of the human body. The anterior lobe is relatively soft, and the corresponding outer support 1 region is also relatively soft. At the same time, after deformation, the outer support 1 moves towards the posterior lobe region as a whole, thereby more effectively ensuring that the outflow tract is not obstructed.

[0041] In this embodiment of the 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 mushroom-shaped and has a smooth surface, which facilitates insertion into the sheath.

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

[0043] In the embodiment of the present application, the upper end of the outer layer support 1 is further sleeved with a flange body 9, and the outer wall of the flange body 9 is provided with a flange sealing edge 10 along the circumference thereof. Specifically, the flange body 9 can be used for sealing when suturing the material, and further, the flange sealing edge 10 is provided to prevent the periphery leakage of the valve.

[0044] In the embodiment of the present application, the outer wall of the flange body 9 is uniformly provided with a plurality of tree-shaped encryption structures 11. Specifically, the tree-shaped encryption structure 11 is used to encrypt the periphery of the flange body 9 to reduce / prevent the periphery leakage of the valve.

[0045] In the embodiment of the present application, the inner side of the outer layer support 1 is circumferentially provided with an outer support surrounding edge 12. Specifically, the periphery leakage of the valve is prevented.

[0046] In the embodiment of the present application, the barb assembly includes a first barb group and a second barb group circumferentially arranged along the outer wall of the outer layer support 1, and the first barb group is located above the second barb group. The first barb group includes a plurality of first barb bodies 13 equally spaced and arranged on the outer wall of the outer layer support 1, and the second barb group includes a plurality of second barb bodies 14 equally spaced and arranged on the outer wall of the outer layer support 1, and the first barb body 13 and the second barb body 14 are arranged in a 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 for anchoring on the original valve ring of the human body, the second barb body 14 is used for anchoring on the original valve leaflet of the human body, and further, the bending angle and length of the first barb body 13 and the second barb body 14 are distinguished according to actual needs to ensure that they can be well anchored on the original valve ring and valve leaflet.

[0047] In this embodiment, the lower end of the outer stent 1 is provided with multiple locking claws 15 at equal intervals, and a clearance position 16 is provided between two adjacent locking claws 15; wherein, the lower end of the locking claw 15 is bent inward toward the outer stent 1. Specifically, the locking claws 15 can be used to connect with the delivery device to facilitate a series of operations such as sheath retraction, release, implantation anchoring, and unlocking of the artificial valve device; wherein, the clearance position 16 is located between two locking claws 15, and the mesh of the empty area is concave in the radial direction of the outer stent 1 to reduce interference with the ventricular wall and leaflets, and aligning the clearance position 16 with the LVOT (left ventricular outflow tract) can effectively avoid LVOT obstruction.

[0048] Example 2

[0049] In Embodiment 2 of this application, as Figure 9 As shown, the difference from Embodiment 1 is that the connecting rod 4 is provided with an elastic bending part 17 in the middle. The elastic bending part 17 allows the connecting rod 4 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.

[0050] Example 3

[0051] In Embodiment 3 of this application, as Figure 10 As shown, the difference from Embodiment 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 rotating shaft connector 5 and is movably connected to the inner support 2 through the rotating shaft connector 5. The lower end of the upper section 18 is rotatably connected to the upper end of the middle section 19 through the upper rotating shaft 21. The lower end of the middle section 19 is rotatably connected to the upper end of the lower section 20 through the lower rotating shaft 22. The lower end of the lower section 20 is rotatably connected to the rotating shaft connector 5 and is movably connected to the outer support 1 through the rotating shaft connector 5. Specifically, under the above configuration, when the connecting rod 4 is subjected to force, the middle section 19 rotates inward along the radial direction of the outer support 1, reducing the gap between the inner support 2 and the outer support 1, ensuring that the deformation force of the outer support 1 does not directly act on the inner support 2, and avoiding deformation of the inner support 2; wherein, the middle section, the upper rotating shaft, and the lower rotating shaft form the connecting rotating assembly of this application embodiment.

[0052] Furthermore, the upper section 18 has an upper limit protrusion 23 on one side of its lower end that abuts against the upper end of the middle section 19, and the lower section 20 has a lower limit protrusion 24 on one side of its upper end that abuts against the lower end of the middle section 19. Under the action of the upper limit protrusion 23 and the lower limit protrusion 24, the middle section 19 is ensured to stop rotating after rotating to a certain angle. This effectively prevents the connecting rod 4 from rotating excessively and causing the knot to fail to spring back to its original position, thus avoiding affecting the overall function of the outer support 1 and the inner support 2.

[0053] Example 4

[0054] In Embodiment 4 of this application, as Figure 11 As shown, the difference from Embodiment 1 is that: multiple connecting rods 4 are integrally connected and formed into a wave-like structure; several rods 25 protrude from the inner and outer sides of the wave-like structure to connect with the inner support 2 and the outer support 1, and the wave-like structure is provided with several peaks 26 and valleys 27, which can play a buffering role.

[0055] Example 5

[0056] In Embodiment 5 of this application, as Figure 12 As shown, the difference from Embodiment 1 is that the pivot connector 5 is a binding wire 28 or a binding metal wire. By tying the binding wire 28 into a knot or binding the metal wire, the connection between the pivot connector 5 and the inner support 2 and the outer support 1 can have a small range of freedom, which can achieve better buffering and also play a supporting role.

[0057] Example 6

[0058] In Embodiment Six of this application, as Figures 13 to 14 As shown, the difference from Embodiment 1 is that the rotating shaft connector 5 includes a left connecting part 29 and a right connecting part 30. The left connecting part 29 and the right connecting part 30 are detachably connected, which can be achieved by threaded connection, making it convenient for assembly and disassembly.

[0059] 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 prosthetic heart valve device, characterized by: The artificial valve comprises an outer layer support, an inner layer support and artificial valve leaflets, the artificial valve leaflets are arranged inside the inner layer support, the outer periphery of the outer layer support is provided with a barb assembly, the outer layer support is sleeved on the outer periphery of the inner layer support, a plurality of connecting rods are arranged at equal intervals between the outer layer support and the inner layer support, rotating shaft connecting pieces are arranged at both ends of the connecting rod, and the connecting rod is movably connected with the outer layer support and the inner layer support through the rotating shaft connecting pieces, and a buffer space is formed between adjacent two connecting rods.

2. The prosthetic heart valve device of claim 1, 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.

3. The prosthetic heart valve device of claim 1, 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.

4. The prosthetic heart valve device of claim 1, wherein: A flange body is further 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 the circumference thereof.

5. The prosthetic heart valve device of claim 4, wherein: A plurality of tree-shaped encryption structures are uniformly arranged on the outer wall of the flange body.

6. The prosthetic heart valve device of claim 1, wherein: An outer support surrounding edge is arranged on the inner side of the outer layer support along the circumference thereof.

7. The prosthetic heart valve device of claim 1, wherein: The barb assembly comprises a first barb group and a second barb group arranged along the outer wall of the outer layer support along the circumference thereof, and the first barb group is arranged above the second barb group.

8. The prosthetic heart valve device of claim 7, wherein: The first barb group comprises a plurality of first barb bodies arranged at equal intervals on the outer wall of the outer layer support, the second barb group comprises a plurality of second barb bodies arranged at equal intervals on the outer wall of the outer layer support, and the first barb bodies and the second barb bodies are arranged in a staggered manner.

9. The prosthetic heart valve device of claim 1, wherein: An elastic bending part or a connecting rotating assembly is arranged at the middle part of the connecting rod.

10. The prosthetic heart valve device of claim 1, wherein: A plurality of locking claws are arranged at equal intervals on the lower end of the outer layer support, and an empty space is arranged between adjacent two locking claws, and the lower end of the locking claw is arranged to be bent towards the inner side of the outer layer support.

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