Nitinol fatigue strain limit versus both strain amplitude (range 0.25-1.25%) and mean strain (1.0, 2.0, and 4.0%) was investigated using a tension-tension method. In order to apply the fatigue testing results to a nitinol stent and evaluate stent fatigue performance, the dog-bone style specimens were processed from the same raw material common to implantable stent manufacturing, i.e., similar nitinol tubing, surface quality, and electropolished surface. To simulate a physiological environment, the tension-tension fatigue tests were conducted in water at 37°C. This strain-controlled fatigue test was conducted with a run-out set at 10 6 cycles. The fatigue strain limit at 10 6 cycles as well as the mean strain effect and the effects of inclusions are discussed. Fatigue results appeared in a bi-modal pattern when the strain amplitude was at a level between too high, which made all specimens to fail, and too low, which allowed all specimens to survive.
Finite Element Analysis (FEA) of Nitinol medical devices has become prevalent in the industry. The analysis methods have evolved in time with the knowledge about the material, the manufacturing processes, the testing or in vivo loading conditions, and the FEA technologies and computing power themselves. As a result, some common practices have developed. This paper presents a study in which some commonly made assumptions in FEA of Nitinol devices were challenged and their effect was ascertained. The base model pertains to the simulation of the fabrication of a diamond shape stent specimen, followed by cyclic loading. This specimen is being used by a consortium of several stent manufacturers dedicated to the development of fatigue laws suitable for life prediction of Nitinol devices. The FEA models represent the geometry of the specimens built, for which geometrical tolerances were measured. These models use converged meshes, and all simulations were run in the FEA code Abaqus making use of its Nitinol material models. Uniaxial material properties were measured in dogbone specimens subjected to the same fabrication process as the diamond specimens. By convention, the study looked at computed geometry versus measured geometry and at the maximum principal strain amplitudes during cyclic loading. The first aspect studied was the effect of simulating a single expansion to the final diameter compared to a sequence of three partial expansions each followed by shape setting. The second aspect was to ascertain whether it was feasible to conduct the full analysis with a model based on the electropolished dimensions or should an electropolish layer be removed only at the end of fabrication, similar to the manufacturing process. Finally, the effect of dimensional tolerances was studied. For this particular geometry and loading, modeling of a single expansion made no discernable difference. The fabrication tolerances were so tight that the effect on the computed fatigue drivers was also very small. The timing of the removal of the electropolished layer showed an effect on the results. This may have been so, because the specimen studied is not completely periodic in the circumferential direction.
The uniaxial behavior of Nitinol in different forms and at different temperatures has been well documented in the literature. Mathematical models for the three-dimensional behavior of this class of materials, covering superelasticity, plasticity, and shape memory effects have been previously developed. Phenomenological models embedded in FEA analysis are part of common practice today in the development of devices made out of Nitinol. In vivo loading of medical devices has cyclic characteristics. There have been some indications in the literature that cyclic loading of Nitinol modifies substantially its behavior. A consortium of several stent manufacturers, Safe Technology and Dassault Systèmes Simulia Corp., dedicated to the development of fatigue laws suitable for life prediction of Nitinol devices, has conducted an extensive experimental study of the modifications in uniaxial behavior of both Nitinol wire and tubing due to cyclic loading. The Abaqus Nitinol material model has been extended to capture some of the phenomena observed and is described in this article. Namely, a preload beyond 6% strain alters the transformation plateaus; if the cyclic load amplitude is large enough, permanent deformations (residual martensite) are observed; the lower plateau increases; and the upper plateau changes. The modifications to the upper plateau are very interesting in the sense that it appears broken: its start stress gets lowered creating a new plateau up to the highest level of cyclic strain, followed by resuming the original plateau until full transformation. Since quite often the geometry of a device at the point at which it is subjected to cyclic loading is very much dependent on the manufacturing, deployment, and preloading sequence, it is important that analyses be conducted with the original material behavior up to that point, and then with the cyclic behavior thereafter.
The widespread development and use of implants made from NiTi is accompanied by the publication of many NiTi material characterization studies. These publications have increased significantly the knowledge about the mechanical properties of NiTi. However, this knowledge also increased the complexity of the numerical simulation of NiTi implants or devices. This study is focused on the uniaxial behavior of NiTi tubing due to cyclic loading and had the goal to deliver both precise and application-oriented results. Single aspects of this study have already been published (Wagner in Ein Beitrag zur strukturellen und funktionalen Ermü dung von Drähten und Federn aus NiTi-Formgedaechtnislegierungen, Ph.D. Thesis, 2005; Eucken and Duerig in Acta Metall 37: 2245-2252, 1989 Yawny et al. in Z Metallkd 96:608-618, 2005); however, there is no publication known that shows all the single effects combined in a ''duty cycle case.'' It was of particular importance to summarize the main effects of pre-strain and subsequent small or large strain amplitudes on the material properties. The phenomena observed were captured in an extended Abaqus Ò Nitinol material model, presented by Rebelo et al. (A Material Model for the Cyclic Behavior of Nitinol, SMST Extended Abstracts 2010). The cyclic tensile tests were performed using a video extensometer to obtain accurate strain measurement on small electro-polished dog-bone specimen that were incorporated into a stent framework so that standard manufacturing methods could be used for the fabrication. This study indicates that a prestrain beyond 6% strain alters the transformation plateaus and if the cyclic displacement amplitude is large enough, additional permanent deformations are observed, the lower plateau and most notably the upper plateau change. The changes to the upper plateau are very interesting in the sense that an additional stress plateau develops: its ''start stress'' is lowered thereby creating a new plateau up to the highest level of cyclic strain, followed by resuming the original plateau until full transformation. This study was conducted in the course of the work of a consortium of several stent manufacturers, SAFE Technology Limited and Dassault Systèmes Simulia Corp., dedicated to the development of fatigue laws suitable for life prediction of Nitinol devices.
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