title: Fatigue and durability of Nitinol stents.
abstract: Nitinol self-expanding stents are effective in treating peripheral artery disease, including the superficial femoral, carotid, and renal arteries. However, fracture occurrences of up to 50% have been reported in some stents after one year. These stent fractures are likely due to in vivo cyclic displacements. As such, the cyclic fatigue and durability properties of Nitinol-based endovascular stents are discussed in terms of an engineering-based experimental testing program. In this paper, the combined effects of cardiac pulsatile fatigue and stent-vessel oversizing are evaluated for application to both stents and stent subcomponents. In particular, displacement-controlled fatigue tests were performed on stent-like specimens processed from Nitinol microtubing. Fatigue data were collected with combinations of simulated oversizing conditions and pulsatile cycles that were identified by computer modeling of the stent that mimic in vivo deformation conditions. These data are analyzed with non-linear finite element computations and are illustrated with strain-life and strain-based constant-life diagrams. The utility of this approach is demonstrated in conjunction with 10 million cycle pulsatile fatigue tests of Cordis SMART Control((R)) Nitinol self-expanding stents to calculate fatigue safety factors and thereby predict in vivo fatigue resistance. These results demonstrate the non-linear constant fatigue-life response of Nitinol stents, whereby, contrary to conventional engineering materials, the fatigue life of Nitinol is observed to increase with increasing mean strain.
authors.affiliation: Nitinol Devices and Components, 47533 Westinghouse Dr., Fremont, CA 94539, United States. apfremont@yahoo.com
authors.forename: A R
authors.initials: AR
authors.lastname: Pelton
authors.forename: V
authors.initials: V
authors.lastname: Schroeder
authors.forename: M R
authors.initials: MR
authors.lastname: Mitchell
authors.forename: Xiao-Yan
authors.initials: XY
authors.lastname: Gong
authors.forename: M
authors.initials: M
authors.lastname: Barney
authors.forename: S W
authors.initials: SW
authors.lastname: Robertson
mesh_terms: D000497:Alloys / Q000737:chemistry*; D001807:Blood Vessel Prosthesis; D019245:Compressive Strength; D003198:Computer Simulation; D017076:Computer-Aided Design; D055119:Elastic Modulus; D004867:Equipment Design; D019544:Equipment Failure Analysis; D006244:Hardness; D008962:Models, Theoretical; D015607:Stents; D013718:Tensile Strength
chemical_list: D000497:Alloys; C013616:nitinol