Annuloplasty ring with reduced dehiscence

• US 10,543,089 B2
• Filed: 10/24/2016
• Issued: 01/28/2020
• 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): Woznicki, Jacqueline
• Application Number:
  US15/333,055
• Publication Number:
  US 20170042679A1
• Time in Patent Office: 1,191 Days
• 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 tricuspid annuloplasty ring, comprising:

a ring core made of a relatively rigid material and 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 that surrounds the ring core along its length and extends circumferentially from both free ends into the gap to form floppy regions through which sutures may be passed to secure the annuloplasty ring to a valve annulus, the floppy regions being axially flattened, wherein the annuloplasty ring defined by the ring core and interface has an asymmetrical ovoid shape shaped for implanting at the tricuspid 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 floppy regions are not radially larger than a portion of the suture-permeable interface surrounding the ring core.

4. The annuloplasty ring of claim 1, wherein the floppy regions extend circumferentially between about 3-10 mm past the free ends.

5. The annuloplasty ring of claim 1, wherein the floppy regions extend circumferentially between about 20-25 mm past the free ends.

6. The annuloplasty ring of claim 1, wherein the suture-permeable interface comprises an elastomeric sleeve surrounding the ring core and a fabric covering around the elastomeric sleeve.

7. The annuloplasty ring of claim 6, wherein the elastomeric sleeve is molded around the ring core and defines a shape of the floppy regions surrounded by the fabric covering.

8. The annuloplasty ring of claim 6, wherein the elastomeric sleeve is molded around the ring core, and the floppy regions comprise only the fabric covering.

9. The annuloplasty ring of claim 8, wherein the floppy regions are not radially larger than a portion of the suture-permeable interface surrounding the ring core.

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

11. The annuloplasty ring of claim 1, wherein the ring core comprises a Cobalt Chromium alloy member.

12. A prosthetic tricuspid annuloplasty ring, comprising:

a ring core made of a relatively rigid material and 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 that surrounds the ring core along its length and extends circumferentially from both free ends into the gap to form floppy ends more flexible than the ring core and through which sutures may be passed to secure the annuloplasty ring to a valve annulus, wherein the suture-permeable interface comprises an elastomeric sleeve immediately surrounding the ring core and a fabric covering around the sleeve, with the elastomeric sleeve forming no part of the floppy ends, wherein the floppy ends are not radially larger than a portion of the interface surrounding the ring core, and wherein the annuloplasty ring defined by the ring core and interface has an asymmetrical ovoid shape shaped for implanting at the tricuspid annulus.

13. The annuloplasty ring of claim 12, wherein the floppy ends are axially flattened.

14. The annuloplasty ring of claim 12, wherein the floppy ends extend circumferentially between about 20-25 mm past the free ends.

15. The annuloplasty ring of claim 12, wherein the ring core has free ends that are more flexible than a mid-portion of the ring core.

16. The annuloplasty ring of claim 12, wherein the elastomeric sleeve is molded around the ring core and defines a shape of the floppy ends surrounded by the fabric covering.

17. The annuloplasty ring of claim 12, wherein the elastomeric sleeve is molded closely around the ring core, and the floppy ends comprise only the fabric covering.

18. The annuloplasty ring of claim 12, wherein the floppy ends comprise only fabric.

19. The annuloplasty ring of claim 12, wherein the ring core comprises a solid titanium alloy member.

20. The annuloplasty ring of claim 12, wherein the ring core comprises a Cobalt Chromium alloy member.