Reduced dehiscence annuloplasty ring

• US 8,932,350 B2
• Filed: 11/28/2011
• Issued: 01/13/2015
• Est. Priority Date: 11/30/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Brunnett, William C., Curtis, Alison S.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Woznicki, Jacqueline
• Application Number:
  US13/305,546
• Publication Number:
  US 20120136435A1
• Time in Patent Office: 1,142 Days
• Field of Search: 623/2.36
• US Class Current: 623/2.36
• 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 2/2448 D-shaped rings
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0004 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0019 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2250/0036 differing in thickness

Abstract

A prosthetic remodeling annuloplasty ring for use in tricuspid or mitral valve repairs to provide support after annuloplasty surgery. The annuloplasty ring includes a relatively rigid core extending around an axis that is discontinuous to define two free ends. A suture-permeable interface surrounding the core includes floppy regions adjacent both free ends of the core. Sutures are used to attach the annuloplasty ring to the annulus, including at least one suture through each of the floppy regions to secure the free ends of the ring and minimize the risk of ring dehiscence, or pull through of the sutures through the annulus tissue. The floppy regions may project from each free end into the gap toward each other, be radially enlarged such as paddle-like extensions, or may comprise outwardly lateral extensions at the free ends of the core.

Claims

1. A prosthetic annuloplasty ring, comprising:

a relatively rigid ring core defining a discontinuous periphery around an axis along an inflow-outflow direction with a first free end separated from a second free end across a gap; and

a suture-permeable interface surrounding the ring core along its length, wherein the interface forms floppy regions that extend circumferentially and cantilevered from both free ends and towards each other into the gap and through which sutures may be passed to secure the annuloplasty ring to a valve annulus.

2. The annuloplasty ring of claim 1, wherein the floppy regions comprise enlarged paddle-shaped generally circular extensions.

3. The annuloplasty ring of claim 1, wherein the interface comprises an elastomeric sleeve closely surrounding the ring core and a fabric covering around the sleeve.

4. The annuloplasty ring of claim 3, wherein the elastomeric sleeve is molded around the ring core and defines a shape of the floppy regions surrounded by the fabric covering.

5. The annuloplasty ring of claim 3, wherein the elastomeric sleeve is molded closely around the ring core, and the floppy regions comprise only the fabric covering.

6. The annuloplasty ring of claim 1, wherein the ring core comprises a solid titanium alloy member.

7. The annuloplasty ring of claim 1, wherein the ring core has a gradually diminishing cross-section from a midsection to the free ends such that the free ends are more flexible in bending than the midsection.

8. The annuloplasty ring of claim 7, wherein the free ends are more flexible in up-and-down bending than radial bending.

9. The annuloplasty ring of claim 1, wherein the annuloplasty ring is shaped for implanting at the tricuspid annulus, and has an asymmetrical ovoid shape.

10. The annuloplasty ring of claim 1, wherein the annuloplasty ring is shaped for implanting at the mitral annulus, and has a generally rounded D-shape.

11. A prosthetic annuloplasty ring, comprising:

a relatively rigid ring core defining a discontinuous periphery around an axis along an inflow-outflow direction with a first free end separated from a second free end across a gap; and

a suture-permeable interface surrounding the ring core along its length, wherein the interface forms floppy regions that extend and are cantilevered radially outward at both free ends of the core and through which sutures may be passed to secure the annuloplasty ring to a valve annulus.

12. The annuloplasty ring of claim 11, wherein the enlarged floppy regions extend between 2-4 times farther outward than a portion of the suture-permeable interface that extends along the length of the core between the enlarged floppy regions.

13. The annuloplasty ring of claim 11, wherein the interface comprises an elastomeric sleeve closely surrounding the ring core and a fabric covering around the sleeve.

14. The annuloplasty ring of claim 13, wherein the elastomeric sleeve is molded around the ring core and defines a shape of the enlarged floppy regions surrounded by the fabric covering.

15. The annuloplasty ring of claim 13, wherein the elastomeric sleeve is molded closely around the ring core, and the enlarged floppy regions comprise only the fabric covering.

16. The annuloplasty ring of claim 11, wherein the ring core comprises a solid titanium alloy member.

17. The annuloplasty ring of claim 11, wherein the ring core has a gradually diminishing cross-section from a midsection to the free ends such that the free ends are more flexible in bending than the midsection.

18. The annuloplasty ring of claim 17, wherein the free ends are more flexible in up-and-down bending than radial bending.

19. The annuloplasty ring of claim 11, wherein the annuloplasty ring is shaped for implanting at the tricuspid annulus, and has an asymmetrical ovoid shape.

20. The annuloplasty ring of claim 11, wherein the annuloplasty ring is shaped for implanting at the mitral annulus, and has a generally rounded D-shape.

21. The annuloplasty ring of claim 11, wherein the interface extends both radially outward and inward so as to be cantilevered towards each other across the gap to form enlarged paddle-shaped floppy regions.