Methods of implanting an annuloplasty ring for reduced dehiscence

• US 9,474,607 B2
• Filed: 01/12/2015
• Issued: 10/25/2016
• 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:
  US14/595,075
• Publication Number:
  US 20150127099A1
• Time in Patent Office: 652 Days
• US Class Current: 1/1
• 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 method of implanting a prosthetic annuloplasty ring, comprising:

providing an annuloplasty ring having a relatively rigid ring core defining a discontinuous periphery around a blood flow orifice 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 includes enlarged floppy regions adjacent both free ends that are larger than any other area of the interface, through which sutures may be passed to secure the annuloplasty ring to a valve annulus, wherein the floppy regions extend radially outward and circumferentially from both free ends toward each other into the gap such that the closest points across the gap are unsupported by the core;

pre-installing sutures at a valve annulus including passing the sutures entirely through the valve annulus;

threading the pre-installed sutures through the suture-permeable interface around the annuloplasty ring, including threading at least one suture through each of the enlarged floppy regions;

parachuting the annuloplasty ring down the pre-installed sutures; and

securing the annuloplasty ring against the valve annulus using the pre-installed sutures,

wherein the interface comprises a molded elastomeric sleeve closely surrounding the ring core and a fabric covering around the sleeve, and the enlarged floppy regions comprise an extension of the fabric covering without the elastomeric sleeve.

2. The method of claim 1, wherein the valve annulus has a first side on which the annuloplasty ring will be implanted and a second side opposite thereto, and wherein the step of pre-installing sutures includes passing at least some of the sutures through a pledget comprising a securing plate formed of a suture-permeable and flexible material positioned on the second side of the annulus and opposite the enlarged floppy regions of the annuloplasty ring.

3. The method of claim 1, wherein the step of threading the pre-installed sutures through the suture-permeable interface around the annuloplasty ring includes threading the pre-installed sutures through an outer edge of the interface formed around the periphery thereof.

4. The method of claim 3, wherein the enlarged floppy regions comprise paddle-shaped generally circular extensions, and the pre-installed sutures are installed on both outer and inner edges of the generally circular extensions.

5. The method 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.

6. A method of implanting a prosthetic annuloplasty ring, comprising:

providing an annuloplasty ring having a relatively rigid ring core defining a discontinuous periphery around a blood flow orifice 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 from both free ends toward each other into the gap such that the closest points across the gap are unsupported by the core and that are larger than any other area of the interface through which sutures may be passed to secure the annuloplasty ring to a valve annulus;

pre-installing sutures at a valve annulus including passing the sutures entirely through the valve annulus;

threading the pre-installed sutures through the suture-permeable interface around the annuloplasty ring, including threading at least one suture through each of the floppy regions;

parachuting the annuloplasty ring down the pre-installed sutures; and

securing the annuloplasty ring against the valve annulus using the pre-installed sutures,

wherein the interface comprises a molded elastomeric sleeve closely surrounding the ring core and a fabric covering around the sleeve, and the floppy regions comprise an extension of the fabric covering without the elastomeric sleeve.

7. The method of claim 6, wherein the valve annulus has a first side on which the annuloplasty ring will be implanted and a second side opposite thereto, and wherein the step of pre-installing sutures includes passing at least some of the sutures through a pledget comprising a securing plate formed of a suture-permeable and flexible material positioned on the second side of the annulus and opposite the floppy regions of the annuloplasty ring.

8. The method of claim 6, wherein the step of threading the pre-installed sutures through the suture-permeable interface around the annuloplasty ring includes threading the pre-installed sutures through an outer edge of the interface formed around the periphery thereof.

9. The method of claim 6, wherein the floppy regions extend a distance L of between about 20-25 mm past the free ends of the core.

10. The method of claim 6, 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.

11. The method of claim 6, wherein the floppy regions extend radially outward from adjacent portions of the interface at both free ends of the core.

12. The method of claim 11, wherein the valve annulus has a first side on which the annuloplasty ring will be implanted and a second side opposite thereto, and wherein the step of pre-installing sutures includes passing at least some of the sutures through a pledget comprising a securing plate formed of a suture-permeable and flexible material positioned on the second side of the annulus and opposite the floppy regions of the annuloplasty ring.

13. The method of claim 11, wherein the elastomeric sleeve incudes an outer bulge formed on an outer edge around the ring providing a sewing cuff, and the step of threading the pre-installed sutures through the suture-permeable interface around the annuloplasty ring includes threading the pre-installed sutures through the sewing cuff around the ring.

14. The method of claim 13, wherein the floppy regions extend between 2-4 times farther radially outward than the sewing cuff.

15. The method of claim 13, 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.

16. The method of claim 13, wherein the annuloplasty ring has an asymmetrical ovoid shape configured for implanting at the tricuspid annulus.