Multi-stranded heat set annuloplasty rings
AssigneeEdwards Lifesciences Corporation
InventorsJohn F. Migliazza, Ruggero De Paulis
Life of this patent
Estimating the term…
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.
Claims13
A method for forming an annuloplasty ring, comprising:
- providing a flexible core member comprising a braided metal cable made of a metal having an austenite start temperature of at least 500° C.;
- providing a holding fixture having a base member and at least one clamping member, wherein the base member and clamping member have complementary channels therein that together provide a three-dimensional mold for the desired peripheral shape of the annuloplasty ring;
- holding the core member in a desired peripheral shape of the annuloplasty ring by placing the core member between the base member and the at least one clamping member;
- while being held in the desired peripheral shape, heating the core member above its austenitic final temperature and maintaining that temperature for a period of time to cause a crystalline structure alteration from martensitic to austenitic;
- cooling the core member with a quench;
- and
- adding a suture-permeable outer covering around the flexible core member.
Dependencies are inferred from the claim text.