Minimally-invasive cardiac-valve prosthesis

• US 9,867,695 B2
• Filed: 08/09/2013
• Issued: 01/16/2018
• Est. Priority Date: 03/03/2004
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Stacchino, Carla, Bergamasco, Giovanni, Burriesci, Gaetano
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US13/963,191
• Publication Number:
  US 20130325112A1
• Time in Patent Office: 1,621 Days
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A cardiac-valve prosthesis is adapted for percutaneous implantation. The prosthesis includes an armature adapted for deployment in a radially expanded implantation position, the armature including a support portion and an anchor portion, which are substantially axially coextensive with respect to one another. A set of leaflets is coupled to the support portion. The leaflets can be deployed with the armature in the implantation position. The leaflets define, in the implantation position, a flow duct that is selectably obstructable. The anchor portion can be deployed to enable anchorage of the cardiac-valve prosthesis at an implantation site.

Claims

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

positioning a cardiac valve prosthesis at an implantation site corresponding to the location of the native aortic valve, the cardiac valve prosthesis including an armature and a set of valve leaflets, the armature having a first end portion distal to the set of valve leaflets, an opposite second end portion proximal to the set of valve leaflets, a principal axis extending longitudinally through the first end portion and the second end portion, a plurality of valve support ribs extending longitudinally from the first end portion to the second end portion, and a plurality of anchoring ribs, wherein each of the plurality of anchoring ribs extends longitudinally from the first end portion to the second end portion, the set of valve leaflets coupled to and supported by the valve support ribs; and

allowing the armature to expand such that each of the plurality of anchoring ribs arches longitudinally radially outward from the principal axis to anchor the cardiac valve prosthesis at the implantation site.

2. The method of claim 1, wherein positioning the cardiac valve prosthesis at the implantation site includes positioning the cardiac valve prosthesis at the implantation site with the armature in a radially compressed condition.

3. The method of claim 2, wherein the steps of positioning the cardiac valve prosthesis at the implantation site and allowing the armature to expand are performed without first removing leaflets of the native aortic valve.

4. The method of claim 1, wherein the plurality of anchoring ribs include three sets of anchoring ribs spaced about the principal axis of the cardiac valve prosthesis, each set of anchoring ribs located so as to extend into and adhere to a respective one of a Valsalva sinus located distal to the native aortic valve when the armature is allowed to expand.

5. The method of claim 4, wherein the plurality of valve support ribs includes three valve support ribs spaced about the principal axis of the cardiac valve prosthesis, the valve support ribs defining lines of commissure of the set of valve leaflets.

6. The method of claim 5, wherein each of the valve support ribs includes a generally straight portion.

7. The method of claim 1, wherein each of the plurality of anchoring ribs includes a top part and a bottom part, and wherein allowing the armature to expand includes allowing the armature to expand such that the top part of each of the anchoring ribs arches longitudinally radially outward and extends into a respective Valsalva sinus.

8. The method of claim 7, wherein allowing the armature to expand includes allowing the armature to expand such that the bottom part of each of the anchoring ribs extends partially into a ventricular chamber proximal to an annulus of the native aortic valve.

9. The method of claim 8, wherein positioning the cardiac valve prosthesis includes positioning the cardiac valve prosthesis such that the top and bottom parts of the anchoring ribs are positioned astride the annulus of the native aortic valve.

10. The method of claim 1, wherein the armature is made of a material having shape-memory characteristics, and wherein allowing the armature to expand includes retracting a sheath maintaining the armature in a compressed condition.

11. The method of claim 10, wherein the material having shape-memory characteristics is nitinol.

12. The method of claim 1, wherein allowing the armature to expand includes radially expanding the armature using a balloon catheter.

13. The method of claim 1, wherein positioning the cardiac valve prosthesis includes introducing the cardiac valve prosthesis using a catheter.

14. The method of claim 1, wherein allowing the armature to expand includes allowing the armature to expand such that each of the plurality of anchoring ribs arches longitudinally radially outward and extends into and conforms to a wall of a respective Valsalva sinus.

15. The method of claim 1, wherein the cardiac valve prosthesis further includes a flared portion configured to channel blood flow through a flow duct defined by the set of valve leaflets.

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

positioning a cardiac valve prosthesis at an implantation site corresponding to the location of the native aortic valve, the cardiac valve prosthesis including an armature and a set of valve leaflets, the armature having a first end portion, an opposite second end portion, a principal axis extending through the first end portion and the second end portion, a plurality of valve support ribs extending between the first end portion and the second end portion, and a plurality of anchoring ribs, wherein each of the plurality of anchoring ribs is directly connected to the first end portion and to the second end portion and extends from the first end portion to the second end portion, the set of valve leaflets coupled to and supported by the valve support ribs; and

allowing the armature to radially expand such that each of the plurality of anchoring ribs includes a top portion, a bottom portion, and an intermediate portion that arches radially outward from and coplanar with the top portion and the bottom portion and with the principal axis to anchor the cardiac valve prosthesis at the implantation site.

17. The method of claim 16, wherein positioning the cardiac valve prosthesis at the implantation site includes positioning the cardiac valve prosthesis at the implantation site with the armature in a radially compressed condition.

18. The method of claim 17, wherein the steps of positioning the cardiac valve prosthesis at the implantation site and allowing the armature to radially expand are performed without first removing leaflets of the native aortic valve.

19. The method of claim 17, wherein allowing the armature to radially expand includes retracting a sheath maintaining the armature in the radially compressed condition.

20. The method of claim 19, wherein allowing the armature to radially expand includes allowing the armature to radially expand such that each of the plurality of anchoring ribs arches radially outward and extends into a respective Valsalva sinus.