An artificial heart valve

Abstract

The present invention provides an artificial heart valve, comprising: valve leaflets and an annular valve frame. The outer surface of the annular valve frame is provided with N plug-in parts, and the N plug-in parts are evenly distributed in the circumferential direction of the annular valve frame. N is a natural number not less than 2. The first ends of the N plug-in parts are provided with mounting holes, and the N plug-in parts are connected to N traction wires through the mounting holes. The valve leaflets are sutured and fixed to the inner surface of the annular valve frame. When the N traction wires are stretched, the N plug-in parts remain in a straight state. When the N traction wires are not stretched, the first ends of the N plug-in parts bend away from the annular valve frame. In the embodiments of the present invention, by providing N plug-in parts on the annular valve frame and fixing them on the native valve in the human body through the N plug-in parts, the occurrence of perivalvular leakage and regurgitation can be effectively reduced.

Description

Technical Field

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

[0002] Heart and vascular diseases are increasing with increasing life expectancy and have become a common ailment among the elderly. Implanting an artificial heart valve is a common treatment. To improve the fit of artificial heart valves after implantation and reduce the occurrence of problems such as paravalvular leakage and regurgitation, the design of artificial heart valves has been enhanced with a skirt. However, even with the addition of a skirt, implantation of artificial heart valves can still be prone to paravalvular leakage and regurgitation. Summary of the Invention

[0003] The embodiment of the present invention provides an artificial heart valve to solve the problem of paravalvular leakage in the related art.

[0004] To achieve the above-mentioned purpose, an embodiment of the present invention provides an artificial heart valve, comprising: leaflets and an annular valve frame, wherein:

[0005] The outer surface of the annular valve frame is provided with N plug-ins, and the N plug-ins are evenly distributed in the circumferential direction of the annular valve frame, where N is a natural number not less than 2;

[0006] The first ends of the N plug-ins are provided with mounting holes, and the N plug-ins are connected to the N traction wires through the mounting holes;

[0007] The valve leaflet is sutured and fixed to the inner surface of the annular valve frame;

[0008] When the N traction wires are stretched, the N plug-ins remain in a straight state;

[0009] When the N traction wires are not stretched, the first ends of the N plug-ins are bent in a direction away from the annular valve frame.

[0010] As an optional embodiment, the N plug-ins include a first plug-in, a second plug-in and a third plug-in, the shape of the first plug-in, the shape of the second plug-in and the shape of the third plug-in are adapted to each other, and the size of the first plug-in, the size of the second plug-in and the size of the third plug-in are adapted to each other.

[0011] As an optional embodiment, a cutting groove is provided at the first end of the first plug-in, the cutting groove is located in the direction of a first traction wire connected to the mounting hole along the first plug-in, and the N traction wires include the first traction wire;

[0012] When the first traction wire is not stretched, the cutting groove cuts the first traction wire.

[0013] As an alternative embodiment, the first end of the first plug is circular or oval.

[0014] As an alternative embodiment, the second end of the first plug is provided with a protrusion, and the position where the annular valve holder is connected to the first plug is provided with a groove, and the groove is adapted to the protrusion.

[0015] As an alternative embodiment, the first end of the first plug is provided with a wrapping layer, and the wrapping layer is sewn to the first end of the first plug.

[0016] As an alternative embodiment, the wrapping layer is made of polyethylene terephthalate material.

[0017] As an alternative embodiment, the material of the N plugs is a shape memory metal material.

[0018] As an alternative embodiment, the annular valve holder includes at least one compression layer, and the compression layer is composed of a plurality of rhombuses or a plurality of hexagons connected end to end.

[0019] As an alternative embodiment, the material of the annular valve holder is cobalt-chromium alloy.

[0020] One of the technical solutions in the above technical solutions has the following advantages or beneficial effects:

[0021] In the present invention, by providing N plugs on the annular valve holder and fixing the N plugs on the native valve in the human body, the occurrence of paravalvular leakage and regurgitation can be effectively reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the description of the embodiments of the present invention will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0023] Figure 1 is a schematic structural diagram of an artificial heart valve provided by an embodiment of the present invention;

[0024] Figure 2 is one of the N plug anchoring schematic diagrams of the artificial heart valve provided by an embodiment of the present invention;

[0025] Figure 3 is the second of the N plug anchoring schematic diagrams of the artificial heart valve provided by an embodiment of the present invention;

[0026] Figure 4 It is a schematic structural diagram of another artificial heart valve provided by an embodiment of the present invention;

[0027] Figure 5 It is a schematic plan view of a native leaflet provided by an embodiment of the present invention;

[0028] Figure 6 It is a schematic plan position diagram of an artificial heart valve provided by an embodiment of the present invention;

[0029] Figure 7 It is a schematic structural diagram of a first plug provided by an embodiment of the present invention;

[0030] Figure 8 It is a schematic structural diagram of a delivery device provided by an embodiment of the present invention;

[0031] Figure 9 It is a schematic diagram of the delivery process of an artificial heart valve provided by an embodiment of the present invention;

[0032] Figure 10 It is a schematic diagram of the plug and the traction wire during the anchoring process provided by an embodiment of the present invention;

[0033] Figure 11 It is a schematic plan structural diagram of an annular valve frame provided by an embodiment of the present invention. Detailed implementation manners

[0034] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0035] Please refer to Figure 1 , Figure 1 which is a schematic structural diagram of an artificial heart valve provided by an embodiment of the present invention. As shown in Figure 1 , the artificial heart valve includes: leaflets and an annular valve frame

[0036] 10. On the outer surface of the annular valve frame

[0037] 10, there are N plugs

[0038] 20. The N plugs

[0039] In the case where the N traction wires are stretched, the N plugs 20 remain in a straight state;

[0040] In the case where the N traction wires are not stretched, the first ends of the N plugs 20 bend away from the annular valve frame 10.

[0041] In this embodiment, by providing N plugs 20 on the annular valve frame 10, the N plugs 20 can be fixed on the native heart valve in the human body, thereby reducing the occurrence of paravalvular leakage and regurgitation of the artificial heart valve.

[0042] Among them, during the implantation process of the N plugs 20, as Figure 2 shown, Figure 2 The upper figure in shows the case where the N traction wires are stretched. At this time, the N plugs 20 are in a straight state. At this time, the operator can implant the artificial heart valve into the human body through the delivery device. After the artificial heart valve is delivered to the target area, the operator controls the traction wires to make the traction wires slack. At this time, the first ends of the N plugs 20 bend away from the annular valve frame 10 as shown in the middle figure in Figure 2 . The operator can rotate the annular valve frame 10 according to the positions of the N plugs 20 for adjustment, so that the N plugs 20 can be better anchored to the native heart valve in the human body. After the adjustment is completed, the operator releases the N traction wires, and the N plugs 20 are anchored to the native heart valve in the human body, as shown in the lower figure in Figure 2 .

[0043] In addition, the cross-sectional view of the N plugs 20 during the implantation process is as shown in Figure 3 shown, Figure 3 The upper left figure in is the native heart valve in the human body; Figure 3 The upper right figure in is during the implantation process of the N plugs 20. At this time, the N plugs 20 are in a straight state; Figure 3 The lower left figure in is during the implantation process of the N plugs 20. The operator controls the traction wires to make the traction wires slack. At this time, the first ends of the N plugs 20 bend away from the annular valve frame 10. The operator can also rotate the annular valve frame 10 to adjust the positions of the N plugs 20; Figure 3 The lower right figure in is that the artificial heart valve is completely anchored to the native heart valve.

[0044] Among them, the operator can adjust a single traction wire among the N traction wires to control the movement of a single plug.

[0045] As an alternative embodiment, as shown in Figure 4As shown, the N plugs 20 include a first plug 21, a second plug 22, and a third plug 23. The shapes of the first plug 21, the second plug 22, and the third plug 23 are adapted to each other, and the sizes of the first plug 21, the second plug 22, and the third plug 23 are adapted to each other.

[0046] In this embodiment, since the native heart valve in the body is a tricuspid valve, as Figure 5 shown, setting the number of plugs of the artificial heart valve to three can be adapted to the tricuspid valve. As Figure 6 shown, the three plugs are adapted to the three native leaflets in the body, and the three plugs can be stably riveted on the three native leaflets.

[0047] Among them, the shapes of the first plug 21, the second plug 22, and the third plug 23 are set to be adapted to each other, and the sizes of the first plug 21, the second plug 22, and the third plug 23 are set to be adapted to each other, so that the first plug 21, the second plug 22, and the third plug 23 can achieve the same anchoring effect after being implanted into the body.

[0048] As an alternative embodiment, as Figure 7 shown, a cutting groove 202 is provided at the first end of the first plug 21. The cutting groove 202 is located in the direction of the first traction wire connected to the first plug 21 along the mounting hole 201. The N traction wires include the first traction wire;

[0049] When the first traction wire is not stretched, the cutting groove 202 cuts off the first traction wire.

[0050] In this embodiment, since the artificial heart valve needs to be implanted in the human body for a long time, and the first traction wire is used by the operator during the operation process, and the traction wire needs to be removed from the body after use, a cutting groove 202 is provided at the first end of the first plug 21. When the first traction wire is not stretched, the cutting groove 202 cuts off the first traction wire, and then the operator removes the first traction wire from the body.

[0051] Among them, as Figure 8 shown, the delivery device 30 of the artificial heart valve is shown on the left side of the figure. The artificial heart valve to be implanted into the body is installed in the housing 301 of the delivery device 30, as Figure 8 shown in the right figure. The housing 301 can move under the control of the operator to expose the artificial heart valve installed in the housing 301. After the delivery device 30 assembles the artificial heart valve, the operator transports the artificial heart valve to the target position through the delivery device 30, as Figure 9 shown in the upper left figure. At this time, the operator operates the delivery device to control the housing 301 to move backward to expose the artificial heart valve, as Figure 9 shown in the upper middle figure. At this time, the artificial heart valve expands and abuts against the inner wall of the blood vessel, asFigure 9 As shown in the upper right figure of Figure 9 As shown in the lower left figure of

[0052] Among them, as Figure 9 During the inflation process of the artificial heart valve as shown in the upper right figure of Figure 10 As shown in the upper figure of Figure 10 After the artificial heart valve is inflated, the operator rotates the annular valve frame 10 so that the three plugs can be matched to the three native valve leaflets. After the rotation of the annular valve frame 10 is completed, the operator relaxes the traction wire, and at this time the three plugs are bent, as Figure 10 As shown in the middle figure of

[0053] As an alternative embodiment, as Figure 7 shown, the first end of the first plug 21 is set to be circular or elliptical.

[0054] In this embodiment, the first end of the first plug 21 is set to be circular or elliptical, which increases the contact area between the first plug 21 and the native valve leaflet, and can increase the stability after anchoring while reducing the interference with the internal tissues.

[0055] As an alternative embodiment, the second end of the first plug 21 is provided with a protrusion 203, and a groove 101 is provided at the connection position between the annular valve frame 10 and the first plug 21, and the groove 101 is adapted to the protrusion 203.

[0056] In this embodiment, the second end of the first plug 21 is provided with a protrusion 203, as Figure 7 shown, and at the same time a groove 101 is provided at the connection position between the annular valve frame 10 and the first plug 21, as Figure 11 shown in the upper figure of Figure 11 As shown in the lower figure of

[0057] As an alternative embodiment, the first end of the first plug 21 is provided with a wrapping layer, and the wrapping layer is sutured to the first end of the first plug 21.

[0058] In this embodiment, a wrapping layer is provided on the first end surface of the first plug 21. During the anchoring process of the artificial heart valve, the first end of the first plug 21 contacts the native valve leaflet. The wrapping layer can reduce the damage of the first plug 21 to the native valve leaflet tissue and reduce the possible side effects on the human body caused by the first plug 21.

[0059] As an alternative embodiment, the wrapping layer is made of polyethylene terephthalate material.

[0060] In this embodiment, the wrapping layer is made of polyethylene terephthalate material, which can reduce the damage around the native valve leaflet by the first plug 21 to an ideal range and avoid possible problems such as inflammation.

[0061] As an alternative embodiment, the material of the N plugs 20 is a shape memory metal material.

[0062] In this embodiment, the material of the N plugs 20 is a shape memory metal material, so that the plugs can return to their original state when the operator releases the traction wire and can be successfully anchored on the surface of the native valve leaflet.

[0063] Among them, the shape memory metal material is preferably a nickel-titanium alloy material.

[0064] As an alternative embodiment, the annular valve frame 10 includes at least one compression layer, and the compression layer is composed of a plurality of rhombuses or a plurality of hexagons connected end to end.

[0065] In this embodiment, the annular valve frame 10 needs to be compressed first during the implantation process and then expand to its original size in the target area. The plurality of rhombuses or hexagons of the compression layer can achieve this effect while maintaining the strength of the annular valve frame 10 in the axial direction.

[0066] Among them, the annular valve frame 10 includes at least one compression layer, and can also be set to multiple layers. The number of layers of the annular valve frame 10 can be adjusted according to the specific needs of different human bodies to meet the requirements for artificial heart valves of different heights.

[0067] As an alternative embodiment, the material of the annular valve frame 10 is cobalt-chromium alloy.

[0068] In this embodiment, the material of the annular valve frame 10 is cobalt-chromium alloy, so that the annular valve frame 10 can return to its pre-compression structure after being implanted into the body.

[0069] It should be noted that in this text, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, such that a process, method, article or device comprising a series of elements not only includes those elements but also other elements not expressly listed, or elements inherent to such process, method, article or device. Without further limitation, an element defined by the phrase "comprising an..." does not exclude the presence of additional identical elements in the process, method, article or device comprising such element.

[0070] The embodiments of the present invention have been described above in conjunction with the accompanying drawings. However, the present invention is not limited to the above specific embodiments. The above specific embodiments are merely illustrative rather than restrictive. Under the inspiration of the present invention, those of ordinary skill in the art can also make many forms without departing from the spirit of the present invention and the scope protected by the claims, and all of them fall within the protection scope of the present invention.

Claims

1. An artificial heart valve, characterized in that, Comprising: Leaflets and an annular valve frame, wherein, The outer surface of the annular valve frame is provided with N plug-ins, and the N plug-ins are evenly distributed in the circumferential direction of the annular valve frame, and N is a natural number not less than 2; The first ends of the N plug-ins are provided with mounting holes, and the N plug-ins are connected to N traction wires through the mounting holes; The leaflets are sutured and fixed to the inner surface of the annular valve frame; When the N traction wires are stretched, the N plug-ins remain in a straight state; When the N traction wires are not stretched, the first ends of the N plug-ins bend away from the annular valve frame; The N plug-ins include a first plug-in, a second plug-in and a third plug-in, the shapes of the first plug-in, the second plug-in and the third plug-in are adapted to each other, and the sizes of the first plug-in, the second plug-in and the third plug-in are adapted to each other; The first end of the first plug-in is provided with a cutting groove, the cutting groove is located in the direction of the first traction wire connected by the first plug-in along the mounting hole, and the N traction wires include the first traction wire; When the first traction wire is not stretched, the cutting groove cuts off the first traction wire.

2. The artificial heart valve according to claim 1, characterized in that, The first end of the first plug-in is set to be circular or oval.

3. The artificial heart valve according to claim 1, characterized in that, The second end of the first plug-in is provided with a protrusion, and a groove is provided at the connection position of the annular valve frame and the first plug-in, and the groove is adapted to the protrusion.

4. The artificial heart valve according to claim 1, characterized in that, The first end of the first plug-in is provided with a wrapping layer, and the wrapping layer is sutured and connected to the first end of the first plug-in.

5. The artificial heart valve according to claim 4, characterized in that, The wrapping layer is made of polyethylene terephthalate material.

6. The artificial heart valve according to claim 1, characterized in that, The material of the N plug-ins is a shape memory metal material.

7. The artificial heart valve according to claim 1, characterized in that, The annular valve frame includes at least one compression layer, and the compression layer is composed of a plurality of rhombuses or a plurality of hexagons connected end to end.

8. The artificial heart valve according to claim 7, characterized in that, The material of the annular valve frame is cobalt-chromium alloy.

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