Flexible annuloplasty ring

• US 9,326,858 B2
• Filed: 02/05/2013
• Issued: 05/03/2016
• Est. Priority Date: 08/24/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Migliazza, John F., Crockett, Bob, Abram, Tim
• Primary Examiner(s): Sharma, Yashita
• Application Number:
  US13/759,928
• Publication Number:
  US 20130211512A1
• Time in Patent Office: 1,183 Days
• Field of Search: 623 236- 241, 600/37, 606/139, 606151-158
• US Class Current: 1/1
• 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 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

An annuloplasty repair segment for heart valve annulus repair. In one embodiment a multi-stranded cable replaces solid core wire for both the tricuspid and mitral valves. Cable allows for greater deployment flexibility for minimally-invasive surgical (MIS) implant, while still maintaining the required strength and similar tensile properties of solid-core wire. In addition, selective placement of point-welds or other such control points locally control other parameters such as the amount and direction of displacement as the ring undergoes external loading. Cable with well-placed control points result in a MIS annuloplasty ring with sufficient flexibility in the x-y plane to allow a surgeon to squeeze the ring into a small incision, such as for example 1 cm×1 cm, while maintaining structural rigidity under forces exerted on the implanted ring by the cardiac cycle and allowing for asymmetrical deflection to be designed into the product.

Claims

1. An annuloplasty ring adapted for implantation at a native heart valve annulus, consisting essentially of:

a flexible core member comprising a multi-stranded braided cable formed of multiple metallic wire strands wound into multi-strand braids with the multi-strand braids being braided into the multi-stranded braided cable and having elastic properties with a first elastic modulus and a relaxed shape that forms an open ring with two free ends separated across a gap, the relaxed shape defining a peripheral shape of the ring sized to extend around and be in contact with an endocardial surface of the native heart valve annulus and the elastic properties of the braided cable being sufficient to provide remodeling to the annulus when implanted; and

an outer covering of suture-permeable material closely encasing the flexible core member.

2. The annuloplasty ring of claim 1, wherein the multi-stranded braided cable has at least seven multi-strand braids in cross-section.

3. The annuloplasty ring of claim 2, wherein the multi-stranded braided cable has a 7×

7 cross-sectional braid pattern.

4. The annuloplasty ring of claim 2, wherein the multi-stranded braided cable has a 7×

19 cross-sectional braid pattern.

5. The annuloplasty ring of claim 2, wherein the multi-stranded braided cable has a 19×

7 cross-sectional braid pattern.

6. The annuloplasty ring of claim 2, wherein the multi-stranded braided cable has a 7×

7×

7 cross-sectional braid pattern.

7. The annuloplasty ring of claim 1, wherein the multi-stranded braided cable comprises strands of at least two different metals braided together.

8. The annuloplasty ring of claim 1, wherein the multi-stranded braided cable has sufficient flexibility to enable it to be manipulated into an elongated shape to fit within a tubular access device, while the elastic properties cause a return to the relaxed shape when expelled from the tubular access device.

9. The annuloplasty ring of claim 1, wherein the multi-stranded braided cable has sufficient flexibility to enable a bend diameter of <

10 mm without permanent deformation.

10. The annuloplasty ring of claim 1, wherein the multi-stranded braided cable is formed of a Cobalt Chromium alloy of minimum bending diameter of <

10 mm.

11. The annuloplasty ring of claim 1, wherein individual strands of the multi-stranded braided cable are coated with inert polymers.

12. The annuloplasty ring of claim 1, wherein the multi-stranded braided cable has a diameter of less than 2.03 mm (0.08 in).

13. The annuloplasty ring of claim 1, wherein the suture-permeable outer covering comprises a silicone tube closely encasing the core member and a fabric cover surrounding the silicone tube.

14. The annuloplasty ring of claim 13, wherein the two free ends of the flexible core member are capped.

15. The annuloplasty ring of claim 1, further including at least one point-weld on the flexible core member to locally influence the amount and direction of displacement as the ring undergoes external loading.

16. The annuloplasty ring of claim 1, further including at least one discrete control point located on the flexible core member creating a localized region of higher elastic modulus than the flexible core member.

17. The annuloplasty ring of claim 16, wherein at least one control point is bent to control the shape of the core member.

18. The annuloplasty ring of claim 17, wherein the annuloplasty ring is shaped for implant at the mitral annulus and has a convex posterior portion and a relatively straight anterior portion, and wherein there are at least three control points that control the shape.

19. The annuloplasty ring of claim 18, wherein there is a control point centered on a minor axis of the ring in the posterior portion.

20. The annuloplasty ring of claim 17, wherein the annuloplasty ring is shaped for implant at the tricuspid annulus and there are at least three control points that control the shape.

21. The annuloplasty ring of claim 16, wherein the control point comprises a tubular member extending at least 3 mm in length crimped to the flexible core member.

22. The annuloplasty ring of claim 16, wherein the control point comprises a coiled wire extending at least 3 mm in length and helically wrapped around the flexible core member.