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 106 cycles. The fatigue strain limit at 106 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.
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