Multi-stranded heat set annuloplasty rings

• US 10,265,171 B2
• Filed: 06/07/2017
• Issued: 04/23/2019
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Migliazza, John F., De Paulis, Ruggero
• Primary Examiner(s): Hong, John C
• Application Number:
  US15/616,716
• Publication Number:
  US 20170266004A1
• Time in Patent Office: 685 Days
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• 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 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2230/0095 Saddle-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0042 differing in shape-memory transition temperatures, e.g. in martensitic transition temperature, in austenitic transition temperature
• CPC Class Codes: A61F 2310/00005 The prosthesis being constructed from a particular material
• CPC Class Codes: C22F 1/10 of nickel or cobalt or alloys based thereon
• CPC Class Codes: Y10T 29/49826 Assembling or joining
• CPC Class Codes: Y10T 29/49844 Through resilient media
• CPC Class Codes: Y10T 29/49865 by temperature differential [e.g., shrink fit]
• CPC Class Codes: Y10T 29/4989 with spreading of cable strands
• CPC Class Codes: Y10T 29/49908 Joining by deforming
• CPC Class Codes: Y10T 29/49948 Multipart cooperating fastener [e.g., bolt and nut]
• CPC Class Codes: Y10T 29/49968 Metal fusion joining
• CPC Class Codes: Y10T 29/49986 Subsequent to metal working
• CPC Class Codes: Y10T 29/49998 Work holding
• CPC Class Codes: Y10T 29/5353 Assembled on core

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. Stranded cable provides 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 being able to pass through an 18 Fr or smaller catheter, while maintaining structural rigidity under forces exerted on the implanted ring by the cardiac cycle. The particular shape of the annuloplasty ring is fixed using a heat setting process.

Claims

1. An annuloplasty ring, comprising:

a flexible core member formed of a metal heat set, by exposure to a temperature higher than 500°

C. for a period of time, such that the flexible core member has a heat-set shape that corresponds to a native heart valve and has physical properties such that the annuloplasty ring can be deformed, during implantation, to fit through an access device and regain the heat-set shape after exiting the access device and, when attached to the native heart valve, the flexible core member is strong enough to remodel the native heart valve; and

a suture-permeable outer covering around the flexible core member.

2. The annuloplasty ring of claim 1, wherein the flexible core member comprises a braided cable formed of multiple wire strands braided together.

3. The annuloplasty ring of claim 1, wherein the flexible core member comprises a multi-stranded braided cable formed of multiple wire strands wound into multi-strand braids with the multi-strand braids being braided into the multi-stranded braided cable.

4. The annuloplasty ring of claim 3, wherein the multi-stranded braided cable has at least seven multi-strand braids in cross-section.

5. The annuloplasty ring of claim 1, wherein the flexible core member has sufficient flexibility to enable the flexible core member to be deformed into an elongated shape to fit through a tubular access device.

6. The annuloplasty ring of claim 1, wherein the metal is MP35N LT.

7. The annuloplasty ring of claim 1, wherein the metal is Nitinol.

8. The annuloplasty ring of claim 1, wherein the peripheral shape is closed.

9. The annuloplasty ring of claim 1, wherein the peripheral shape is open with two free ends.

10. The annuloplasty ring of claim 9, further including a cap or weld on the two free ends to cover individual strand ends.

11. The annuloplasty ring of claim 1, wherein the flexible core member defines a saddle shape with both a posterior portion and an anterior portion defined by two free ends rising upward from left and right sides.

12. The annuloplasty ring of claim 1, wherein the flexible core member has sufficient flexibility to enable the flexible core member to be passed through a 1 centimeter wide opening and then regain the heat-set shape.

13. The annuloplasty ring of claim 1, wherein the metal has been heat set by exposure to a temperature of 550°

C. or higher.

14. An annuloplasty ring, comprising:

a flexible core member formed of a metal that has been heat set, by exposure to a temperature higher than 500°

C. for a period of time, such that the flexible core member has a heat-set saddle shape with both a posterior portion and an anterior portion defined by two free ends rising upward from left and right sides and has physical properties such that the annuloplasty ring can be straightened, during implantation, to fit through a tubular access device and regain the heat-set saddle shape after exiting the tubular access device and, when attached to a native heart valve, the flexible core member is strong enough to remodel the native heart valve; and

a suture-permeable outer covering around the flexible core member.

15. The annuloplasty ring of claim 14, wherein the flexible core member comprises a multi-stranded braided cable formed of multiple wire strands wound into multi-strand braids with the multi-strand braids being braided into the multi-stranded braided cable.

16. The annuloplasty ring of claim 15, wherein the multi-stranded braided cable has at least seven multi-strand braids in cross-section.

17. The annuloplasty ring of claim 14, wherein the flexible core member further comprises a braided cable that has sufficient flexibility to enable the flexible core member to be passed through a 1 centimeter wide tubular access device and then regain the heat-set saddle shape.

18. The annuloplasty ring of claim 14, further including a cap or weld on the two free ends to cover individual strand ends.

19. The annuloplasty ring of claim 14, wherein the metal has been heat set by exposure to a temperature of 600°

C. or higher.

20. An annuloplasty ring, comprising:

a flexible metal core member having a heat-set shape, set by exposure to a temperature higher than 500°

C., that corresponds to a native heart valve and having an elastic modulus sufficient that the annuloplasty ring can be deformed to fit through a 1 centimeter wide opening during implantation and regain the heat-set shape after passing through the opening and, when attached to the native heart valve, the flexible core member can remodel the native heart valve; and

a suture-permeable outer covering around the flexible core member.