Intra-annular mounting frame for aortic valve repair

• US 10,130,462 B2
• Filed: 04/22/2013
• Issued: 11/20/2018
• Est. Priority Date: 10/06/2006
• Status: Active Grant

• Current Assignee: BioStable Science & Engineering, Inc.
• Original Assignee: BioStable Science & Engineering, Inc.
• Inventors: Rankin, J. Scott
• Primary Examiner(s): Schall, Matthew
• Application Number:
  US13/868,011
• Publication Number:
  US 20140012374A1
• Time in Patent Office: 2,038 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2210/0071 thermoplastic
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses

Abstract

An intra-annular mounting frame for an aortic valve having native aortic cusps is provided which includes a frame body with native leaflet reorienting curvatures and interconnecting points; the curvatures shaped to be received inside the valve below the native aortic cusps and to reorient the native aortic cusps within the aortic valve, where each of the curvatures extends concavely upward from a reference latitudinal plane tangential to each curvature'"'"'s base.

Claims

1. A method of repairing an aortic valve having an aortic wall, native aortic cusps, and commissures, the method comprising:

a) providing an intra-annular mounting frame comprising a plurality of native cusp reorienting curvatures, interconnecting points, and posts,

the intra-annular mounting frame corresponding to the aortic valve and each curvature corresponding to one of the native aortic cusps, the interconnecting points connecting to the curvatures to form the mounting frame;

b) inserting the intra-annular mounting frame into an aortic valve annulus with the curvatures positioned adjacent to where the native aortic cusps connect to the aortic wall; and

c) suturing the intra-annular mounting frame to the aortic valve annulus with the sutures passing through the aortic wall and passing both above and below the native aortic cusps to implant the intra-annular mounting frame into the aortic valve.

2. The method of claim 1, wherein the suturing of step c) further comprises mattress sutures.

3. The method of claim 1, wherein the suturing of step c) further comprises horizontal mattress sutures.

4. The method of claim 3, wherein, the suturing of step c) comprises three horizontal mattress sutures per native aortic cusp.

5. The method of claim 3, wherein the suturing of step c) comprises one horizontal mattress suture per commissure of the aortic valve annulus.

6. The method of claim 3, wherein the suturing of step c) comprises twelve sutures to implant the intra-annular mounting frame into the aortic valve annulus.

7. The method of claim 1, further comprising the sutures passing through perforations in the intra-annular mounting frame.

8. The method of claim 1, further comprising the sutures passing through cloth covering the intra-annular mounting frame.

9. The method of claim 8, further comprising the sutures passing through polyethylene terephthalate cloth covering the intra-annular mounting frame.

10. The method of claim 1, further comprising the sutures passing through pledgets positioned above the native aortic cusps.

11. The method of claim 1, wherein the pledgets comprise polytetrafluoroethylene or pledgets.

12. The method of claim 1, further comprising restoring native aortic cusp coaptation of the aortic valve to proper orientation within the aortic wall by attaching the sutures to the intra-annular mounting frame.

13. The method of claim 1, further comprising:

d) reorienting the cusps and commissures of the aortic valve so that the aortic valve has a diameter of from about 16 millimeters to about 27 millimeters.

14. The method of claim 1, further comprising:

d) reorienting the native cusps and commissures of the aortic valve so that the aortic valve has a diameter of from about 18 millimeters to about 25 millimeters.

15. A method of repairing an aortic valve having an aortic wall, native aortic cusps, and commissures, comprising:

a) providing an intra-annular mounting frame comprising a plurality of native cusp reorienting curvatures, interconnecting points, and posts,

the intra-annular mounting frame corresponding to the aortic valve and each curvature corresponding to one of the native aortic cusps, the interconnecting points connecting to the curvatures to form the mounting frame;

b) inserting the intra-annular mounting frame into an aortic valve annulus with the curvatures positioned adjacent to where the native aortic cusps connect to the aortic wall; and

c) suturing the intra-annular mounting frame into the aortic valve annulus with the sutures engaging the intra-annular mounting frame from below the aortic valve and passing through the aortic wall and under the native aortic cusps to above the cusps to implant the intra-annular mounting frame into the aortic valve to reduce the diameter of the aortic valve.