Novel aortic valve stent and artificial valve

Abstract

The utility model belongs to the technical field of medical instruments, and particularly discloses a novel aortic valve support and an artificial valve. The novel aortic valve stent is made of memory metal wires, is of a grid cylindrical structure and comprises an inflow end stent, a connecting part stent and an outflow end stent. The connecting part bracket comprises an interval side bracket, an interval opposite side bracket and other side wall brackets; the grid area and the metal wire width of the interval side support and the interval opposite side support are larger than those of the other side wall supports, and the metal wire thickness and the deformation amount compliance are smaller than those of the other side wall supports. The artificial valve comprises a novel aortic valve support, axial positioning metal, valve leaflets and an anti-regurgitation skirt edge, wherein the valve leaflets and the anti-regurgitation skirt edge are made of polymer materials. The problems of perivalvular regurgitation, abnormal heart conduction and short service life of the existing artificial valve can be solved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, and in particular to a novel aortic valve stent and an artificial valve. Background Art

[0002] Aortic stenosis (AS) is a structural change of the valve caused by congenital or acquired factors, and its incidence increases with age. Transcatheter active valve replacement (TAVR) is a safe and feasible minimally invasive treatment for severe AS. Since it was first approved by the FDA in 2011 for use in patients with severe AS who are not suitable for surgical treatment, its indications have been continuously expanded to AS populations with low and medium surgical risks. In recent years, the application of TAVR in patients with isolated aortic regurgitation has also received widespread attention.

[0003] After the artificial valve is implanted, it will compress the atrioventricular conduction system located at the root of the aorta, leading to postoperative cardiac conduction abnormalities. If there is insufficient support, it will cause paravalvular regurgitation. At the current stage, artificial valve implantation still cannot effectively solve the clinical pain points of cardiac conduction abnormalities and paravalvular regurgitation. In addition, the mainstream valve material currently used is made of animal pericardium, which has a short service life. Young patients face the risk of secondary valve replacement surgery. Utility Model Content

[0004] The utility model aims to provide a novel aortic valve stent and artificial valve to solve the problems of abnormal cardiac conduction, paravalvular regurgitation and short service life existing in the existing artificial valves.

[0005] In order to achieve the above purpose, the specific technical solutions adopted by the utility model are as follows:

[0006] The first aspect of the utility model is to provide a new type of aortic valve stent, which is made of memory metal wire and has a grid cylindrical structure. From bottom to top, it includes an inflow end stent, a connecting part stent and an outflow end stent; the connecting part stent includes an interval side stent, an interval opposite side stent and the remaining side wall stents arranged between the interval side stent and the interval opposite side stent; the grid area constituting the interval side stent and the interval opposite side stent is larger than the grid area constituting the remaining side wall stents; the metal wire constituting the grid of the interval side stent and the interval opposite side stent is wider and thinner than the metal wire constituting the remaining side wall stents.

[0007] The utility model forms an interval side bracket, an interval opposite side bracket and other side wall brackets by performing differentiated designs on the grid area, wire width and wire thickness of different parts of the connecting part bracket. Such a setting can effectively reduce the compression of the aortic valve bracket on the nerve conduction bundle and solve the problem of abnormal cardiac conduction. At the same time, it ensures that the aortic valve bracket has a good support level and reduces the problem of paravalvular regurgitation.

[0008] Furthermore, the form factor compliance of the memory metal constituting the septal side stent and the septal opposite side stent is smaller than that of the memory metal constituting the remaining side wall stents, so as to generate a smaller radial support force on the septal side. The conduction bundle runs in the ventricular septum, and a larger support force will compress the ventricular septum and then the conduction bundle, resulting in conduction block. The form factor compliance is the support force of the memory metal on the aortic valve when the compression degree is the same.

[0009] Furthermore, the grid of the connecting portion support is in a rhombus shape, and the grids of the inflow end support and the outflow end support are in a rhombus shape or a hexagon shape.

[0010] Furthermore, the radial dimensions of the inflow end stent and the outflow end stent are both larger than the radial dimensions of the connecting portion stent, and the connecting portion stent and the inflow end stent and the outflow end stent are respectively provided with an arc-shaped transition, so that the aortic valve stent is stably stuck at the heart valve orifice position.

[0011] The second aspect of the utility model is to provide a novel artificial valve, which includes the novel aortic valve stent.

[0012] Furthermore, the valve also includes leaflets and an anti-reflux skirt; the leaflets are provided with at least two, which are arranged in the connecting part bracket, have fixed edges and free edges, and the free edges between the leaflets can be pressed against and separated from each other, thereby realizing the closing and opening of the flow channel in the bracket; the anti-reflux skirt is wrapped around the inflow end bracket, is trumpet-shaped, and is attached to the subvalvular tissue to reduce paravalvular leakage and prevent the valve from shifting toward the outflow end.

[0013] Furthermore, a leaflet connecting hole is provided on the connecting portion bracket, and the fixing edge of the leaflet is sutured or embedded in the leaflet connecting hole by silk thread.

[0014] Furthermore, the material of the valve leaflet and the anti-reflux skirt is a polymer, specifically, polyhedral oligomeric silsesquioxane, nanocomposite graphene-siloxane polymer, siloxane polyurethane-urea or poly (styrene-b-isobutylene-b-styrene), poly (styrene-b-4-vinylbenzocyclobutene-b-isobutylene-b-styrene-b-4-vinylbenzocyclobutene), polyethylene terephthalate, bacterial cellulose, linear low-density polyethylene, hyaluronic acid enhanced linear low-density polyethylene, etc. The valve leaflet and the anti-reflux skirt are made of these polymer materials, which have good biocompatibility, hemodynamic properties and service life, and make up for the shortcomings of artificial biological valves and artificial mechanical valves.

[0015] Furthermore, the valve also includes two axial positioning metals extending from the end of the outflow end bracket, and the two axial positioning metals are respectively arranged in the directly opposite areas of the septal side bracket and the septal opposite side bracket. The valve is folded during delivery, and the axial direction of the valve cannot be clearly observed. The axial positioning metals can be used to distinguish the septal side bracket, the septal opposite side bracket and the other side wall brackets, which helps to determine the axial direction of the valve before release and improve the accuracy of the release position.

[0016] The utility model has the following beneficial effects:

[0017] By setting the regional size and characteristics of the connecting part of the aortic valve stent, the pressure of the artificial valve on the nerve conduction bundle is reduced, solving the problem of abnormal cardiac conduction after the artificial valve is implanted, and the artificial valve has sufficient support to fit firmly to the valve orifice, reduce the problem of paravalvular regurgitation, and prevent blood stasis and thrombosis in the gap. By using polymer materials as the material of the leaflets and skirts in the artificial valve, the service life of the artificial valve is increased and the possibility of secondary valve replacement surgery is reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 : Schematic diagram of the structure of the new artificial valve described in Example 1.

[0019] Figure 2 : An expanded view of the new artificial valve described in Example 1.

[0020] In the figure: 1-new aortic valve stent, 2-axial positioning metal, 3-valve leaflet, 4-anti-reflux skirt; 11-inflow end stent, 12-connection part stent, 13-outflow end stent; 121-spacing side stent, 122-spacing opposite side stent, 123-other side wall stents. DETAILED DESCRIPTION

[0021] The present invention is further described below in conjunction with the accompanying drawings and specific embodiments.

[0022] Example 1

[0023] A new type of artificial valve, the structure of Figure 1-2 As shown, it includes a novel aortic valve stent 1, an axial positioning metal 2, a valve leaflet 3 and an anti-reflux skirt 4.

[0024] The novel aortic valve stent 1 is made of memory metal wire and has a grid cylindrical structure, and includes an inflow end stent 11, a connecting part stent 12 and an outflow end stent 13 from bottom to top. The connecting part stent 12 is in a diamond grid shape, and the inflow end stent 11 and the outflow end stent 13 are in a hexagonal grid shape; the radial dimensions of the inflow end stent 11 and the outflow end stent 13 are both larger than the radial dimensions of the connecting part stent 12, and the connecting part stent 12 and the inflow end stent 11 and the outflow end stent 13 are respectively in an arc-shaped transition, so that the entire stent can be stably stuck in the original valve orifice of the heart.

[0025] The connecting part support 12 includes an interval side support 121, an interval opposite side support 122 and the remaining side wall support 123. The interval side support 121 and the interval opposite side support 122 are arranged opposite to each other and have the same structure. The remaining side wall support 123 connects the interval side support 121 and the interval opposite side support 122. The area of ​​the rhombus grid (single) constituting the interval side support 121 and the interval opposite side support 122 is larger than the area of ​​the rhombus grid (single) constituting the remaining side wall support 123; the metal wire constituting the grid of the interval side support 121 and the interval opposite side support 122 is wider and thinner than the metal wire constituting the remaining side wall support 123; the shape variable compliance of the memory metal constituting the interval side support 121 and the interval opposite side support 122 is smaller than the memory metal constituting the remaining side wall support 123. The differentiated setting of these areas of the connecting part support 12 can reduce the compression of the nerve conduction bundle while ensuring the stable support of the support, and simultaneously solve the problems of paravalvular regurgitation and abnormal cardiac conduction.

[0026] The two axial positioning metals 2 are symmetrically arranged, which are sheet structures extending from the end of the outflow end bracket 13 and are used to determine the axial position of the valve before release; the two axial positioning metals 2 are respectively arranged in the opposite areas of the interval side bracket 121 and the interval opposite side bracket 122.

[0027] The valve leaflets 3 are provided with three and are arranged in the connecting part bracket 12. The three valve leaflets form a one-way valve to control the one-way flow of blood from the inflow end to the outflow end of the novel aortic valve bracket 1. Each valve leaflet 3 has a fixed edge and a free edge. The fixed edge is sutured to the valve leaflet connection hole opened in the connecting part bracket 12 by silk thread, and the free edges between the valve leaflets 3 can be pressed against and separated from each other; during the ventricular diastole, the valve leaflets 3 are closed to seal the flow channel so that the blood in the aorta will not flow back to the left ventricle, and during the ventricular systole, the valve leaflets 3 are opened to allow the blood in the left ventricle to flow into the aorta.

[0028] The anti-reflux skirt 4 is wrapped around the inflow end support 11 and is in a trumpet shape. When in use, it is attached to the subvalvular tissue to reduce paravalvular leakage and prevent the valve from shifting toward the outflow end. The anti-reflux skirt 4 and the leaflet 3 are both made of polymer materials, specifically linear low-density polyethylene in this embodiment.

[0029] The method of using the novel artificial valve is as follows: the artificial valve is contracted in the catheter, a catheter guidewire is placed in the femoral artery, the guidewire is passed along the artery to the heart, the guidewire with the artificial valve is passed along the catheter to the original valve position of the left ventricle, the artificial valve is released, the artificial valve is opened and stuck in the original valve orifice, and then the catheter guidewire is withdrawn to complete the placement of the artificial valve. After the artificial valve of this embodiment is placed in the heart, the incidence of cardiac conduction abnormalities and paravalvular regurgitation can be reduced.

[0030] This specific implementation method is only an explanation of the utility model, not a limitation of the utility model. Any changes made by those skilled in the art after reading the specification of the utility model will be protected by the patent law as long as they are within the scope of the claims of the utility model.

Claims

1. A novel aortic valve stent, characterized in that: The invention is made of memory metal wire and has a grid cylindrical structure, and comprises, from bottom to top, an inflow end bracket (11), a connection part bracket (12) and an outflow end bracket (13); the connection part bracket (12) comprises an interval side bracket (121), an interval opposite side bracket (122) and other side wall brackets (123) arranged between the interval side bracket (121) and the interval opposite side bracket (122); the grid area constituting the interval side bracket (121) and the interval opposite side bracket (122) is larger than the grid area constituting the other side wall brackets (123); the metal wire constituting the grid of the interval side bracket (121) and the interval opposite side bracket (122) is wider and thinner than the metal wire constituting the other side wall brackets (123).

2. The novel aortic valve stent according to claim 1, characterized in that: The shape-variable compliance of the memory metal constituting the spacing side bracket (121) and the spacing opposite side bracket (122) is smaller than that of the memory metal constituting the remaining side wall brackets (123).

3. The novel aortic valve stent according to claim 1, characterized in that: The grid of the connection portion bracket (12) is in a rhombus shape, and the grids of the inflow end bracket (11) and the outflow end bracket (13) are in a rhombus shape or a hexagon shape.

4. The novel aortic valve stent according to claim 1, characterized in that: The radial dimensions of the inflow end bracket (11) and the outflow end bracket (13) are both larger than the radial dimensions of the connecting portion bracket (12), and the connecting portion bracket (12) and the inflow end bracket (11) and the outflow end bracket (13) are respectively formed into arc-shaped transitions.

5. A novel artificial valve, characterized in that: A novel aortic valve stent comprising any one of claims 1-4.

6. The novel artificial valve according to claim 5, characterized in that: It also includes leaflets (3) and an anti-reflux skirt (4); the leaflets (3) are provided with at least two and are arranged in the connecting portion bracket (12), and have fixed edges and free edges. The free edges between the leaflets (3) can be pressed against and separated from each other, thereby realizing the closing and opening of the flow channel in the bracket; the anti-reflux skirt (4) is wrapped around the inflow end bracket (11) and is in a trumpet shape.

7. The novel artificial valve according to claim 5, characterized in that: It also includes two axial positioning metals (2) extending from the end of the outflow end bracket (13), and the two axial positioning metals (2) are respectively arranged in the opposite areas of the spacing side bracket (121) and the spacing opposite side bracket (122).

8. The novel artificial valve according to claim 6, characterized in that: The connection portion support (12) is provided with a leaflet connection hole, and the fixing edge of the leaflet (3) is sutured or embedded in the leaflet connection hole by silk thread.

9. The novel artificial valve according to claim 6, characterized in that: The material of the valve leaf (3) and the anti-reflux skirt (4) is polymer.

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