CARDIAC VALVE PROSTHESIS

• US 20130345800A1
• Filed: 08/21/2013
• Published: 12/26/2013
• Est. Priority Date: 02/10/2005
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Stacchino, Carla, Bergamasco, Giovanni, Burriesci, Gaetano, Righini, Giovanni
• Granted Patent: US 8,920,492 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: Y10T 29/49833 Punching, piercing or reaming part by surface of second part

Abstract

A method of repairing a native cardiac valve such as the aortic valve includes positioning a cardiac valve prosthesis at an implantation site proximate the native cardiac valve to be repaired. The cardiac valve prosthesis includes an armature and a plurality of prosthetic valve leaflets, the armature including first and second annular elements, a plurality of anchor members extending between the first and second annular elements, and a plurality of valve support members extending from at least one of the first and second annular elements, the plurality of prosthetic valve leaflets being coupled to and supported by the valve support members. The method further includes radially expanding the cardiac valve prosthesis such that each of the anchor members arches radially outward from the first annular element to the second annular element and engages a wall of a respective one of a plurality of native Valsalva sinuses located distal to the native cardiac valve so as to enable anchorage of the cardiac valve prosthesis at the implantation site.

Claims

1. A method of repairing a native aortic valve, the method comprising:

positioning an aortic valve prosthesis at an implantation site proximate the native aortic valve to be repaired, the aortic valve prosthesis including an armature and a plurality of prosthetic valve leaflets, the armature including first and second annular elements, a plurality of anchor members extending between and connecting the first and second annular elements, and a plurality of valve support members extending from at least one of the first and second annular elements, the plurality of prosthetic valve leaflets being coupled to and supported by the valve support members; and

radially expanding the armature such that each of the anchor members arches radially outward from the first annular element to the second annular element and engages a wall of a respective one of a plurality of native Valsalva sinuses located distal to the native aortic valve so as to enable anchorage of the aortic valve prosthesis at the implantation site.

2. The method of claim 1, wherein radially expanding the armature includes radially expanding the first and second annular elements such that the first annular element engages a wall of a native annulus proximal to the plurality of Valsalva sinuses, and the second annular element engages a wall of a native annulus distal to the plurality of Valsalva sinuses.

3. The method of claim 2, wherein positioning the aortic valve prosthesis at the implantation site is performed with the aortic valve prosthesis in a radially collapsed configuration.

4. The method of claim 3, wherein positioning the aortic valve prosthesis at the implantation site is performed using a catheter.

5. The method of claim 3, wherein the armature is configured to be self-expandable from the radially collapsed configuration to a radially expanded configuration, and wherein radially expanding the armature includes allowing the armature to self-expand toward the radially expanded configuration.

6. The method of claim 5, wherein the armature is made from a material having shape memory properties.

7. The method of claim 6, wherein allowing the armature to self-expand toward the radially expanded configuration includes disengaging the aortic valve prosthesis from a sheath retaining the aortic valve prosthesis in the radially collapsed configuration.

8. The method of claim 1, wherein the first annular element has a proximal end that is flared outward.

9. The method of claim 1, wherein the aortic valve prosthesis includes a valve sleeve including the plurality of prosthetic valve leaflets and a base, the base disposed about the first annular element, the plurality of prosthetic valve leaflets attached to the base.

10. The method of claim 1, wherein the anchor members are angularly displaced from one another about a principal axis of the aortic valve prosthesis.

11. The method of claim 10, wherein the valve support members are angularly displaced from one another and from the anchor members about the principal axis of the aortic valve prosthesis.

12. The method of claim 11, wherein the valve support members are cantilevered from the first annular element.

13. The method of claim 11, wherein the valve support members extend from and are connected to the first and second annular elements.

14. A method of repairing a native aortic valve, the method comprising:

positioning an aortic valve prosthesis in a radially contracted configuration at an implantation site proximate the native aortic valve to be repaired, the cardiac valve prosthesis including an armature and a valve sleeve including a plurality of prosthetic valve leaflets, the armature including first and second annular elements, a plurality of anchor members extending between and connecting the first and second annular elements, and a plurality of valve support members extending between and connected to the first and second annular elements, the valve sleeve being coupled to the armature; and

allowing the armature to radially expand such that each of the anchor members arches radially outward from the first annular element to the second annular element and engages a wall of a respective one of a plurality of native Valsalva sinuses located distal to the native aortic valve so as to enable anchorage of the aortic valve prosthesis at the implantation site.

15. The method of claim 14, wherein allowing the armature to radially expand includes allowing the first and second annular elements to radially expand such that the first annular element engages a wall of a native annulus proximal to the plurality of Valsalva sinuses, and the second annular element engages a wall of a native annulus distal to the plurality of Valsalva sinuses.

16. The method of claim 15, wherein allowing the first and second annular elements to radially expand includes disengaging the aortic valve prosthesis from a sheath retaining the aortic valve prosthesis in the radially collapsed configuration.

17. The method of claim 16, wherein allowing the armature to radially expand includes allowing the armature to radially expand such that each of the anchor members arches radially outward from the first annular element to the second annular element and engages and generally conforms to the wall of the respective one of a plurality of native Valsalva sinuses.

18. The method of claim 15, wherein the valve sleeve further includes a base disposed about the first annular element, and wherein the plurality of prosthetic valve leaflets are attached to the base.

19. The method of claim 18, wherein the anchor members are angularly displaced from one another about a principal axis of the aortic valve prosthesis, and wherein the valve support members are angularly displaced from one another and from the anchor members about the principal axis of the aortic valve prosthesis, and wherein the valve sleeve is attached to each of the valve support members with each one of the plurality of prosthetic valve leaflets extending between two adjacent valve support members.

20. The method of claim 14, wherein positioning the aortic valve prosthesis is performed using a catheter.