Leaflet reinforcement for regurgitant valves

• US 8,348,963 B2
• Filed: 07/03/2003
• Issued: 01/08/2013
• Est. Priority Date: 07/03/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: HLT, Inc. (Bracco SPA)
• Inventors: Wilson, Robert F.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): YABUT, DIANE D
• Application Number:
  US10/613,121
• Publication Number:
  US 20040106989A1
• Time in Patent Office: 3,477 Days
• Field of Search: 606/151, 606/898, 606/213, 606/41, 128/898
• US Class Current: 606/151
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets

Abstract

A support, and a method for attaching said support, for providing additional strength to existing regurgitant or prolapsed valve leaflets. The support restores an otherwise non-functioning, or poorly functioning, native valve to a functioning condition, obviating the need for a complete valve removal or replacement. The support may also be applied to a functioning valve leaflet as a prophylactic measure against future failure. The delivery method includes a delivery mechanism for attaching the support to the native valve leaflet.

Claims

1. A method of reinforcing a native valve leaflet comprising implanting a sutureless reinforcing device to the valve leaflet, said support extending radially into said leaflet and positioned away from adjacent native valve leaflets, thereby allowing any free edges of the valve leaflet to form a seal with free edges of the adjacent native valve leaflets during diastole.

2. The method of claim 1 wherein implanting a reinforcing device to the at least one valve leaflet comprises attaching a reinforcing support to a downstream surface of the at least one valve leaflet.

3. The method of claim 1 wherein implanting a reinforcing device to the at least one valve leaflet comprises attaching a reinforcing support to an upstream surface of the at least one valve leaflet.

4. The method of claim 1 wherein implanting a reinforcing device to the at least one valve leaflet comprises attaching a reinforcing support to both an upstream surface and a downstream surface of the at least one valve leaflet.

5. The method of claim 4 wherein attaching a reinforcing support to both an upstream surface and a downstream surface of the at least one valve leaflet comprises sandwiching the at least one valve leaflet between adjacent support members on opposite sides of the at least one valve leaflet.

6. The method of claim 5 wherein sandwiching the at least one valve leaflet between adjacent support members on opposite sides of the at least one valve leaflet comprises sandwiching the at least one valve leaflet between adjacent, interlocking support members on opposite sides of the at least one valve leaflet.

7. A method of reinforcing a native valve comprising implanting at least one sutureless reinforcing device to at least one valve leaflet, each of said at least one sutureless reinforcing devices corresponding to a single leaflet such that no sutureless reinforcing device contacts more than one leaflet, said at least one sutureless reinforcing device positioned away from free edges of said at least one valve leaflet, thereby allowing any free edges of the at least one valve leaflet to form a seal with free edges of adjacent leaflets during diastole.

8. The method of claim 7 wherein implanting at least one reinforcing device to the at least one valve leaflet comprises attaching a reinforcing support to a downstream surface of the at least one valve leaflet.

9. The method of claim 7 wherein implanting at least one reinforcing device to the at least one valve leaflet comprises attaching a reinforcing support to an upstream surface of the at least one valve leaflet.

10. The method of claim 7 wherein implanting at least one reinforcing device to the at least one valve leaflet comprises attaching a reinforcing support to both an upstream surface and a downstream surface of the at least one valve leaflet.

11. The method of claim 10 wherein attaching a reinforcing support to both an upstream surface and a downstream surface of the at least one valve leaflet comprises sandwiching the at least one valve leaflet between adjacent support members on opposite sides of the at least one valve leaflet.

12. The method of claim 11 wherein sandwiching the at least one valve leaflet between adjacent support members on opposite sides of the at least one valve leaflet comprises sandwiching the at least one valve leaflet between adjacent, interlocking support members on opposite sides of the at least one valve leaflet.