A statistical approach to understand the role of inclusions on the fatigue resistance of superelastic Nitinol wire and tubing.

Superelastic wires and diamond-shaped stent surrogates were manufactured from Nitinol rods and tubing, respectively, from five different mill product suppliers - Standard VAR, Standard VIM, Standard VIM+VAR, Process-Optimized VIM+VAR, and High-Purity VAR. High-cycle fatigue tests up to 10(7) cycles were conducted under tension-tension conditions for wires and bending conditions for diamonds. These materials were compared under both testing methods at 37°C with 6% prestrain and 3% mean strain (unloading plateau) with a range of alternating strains. The High-Purity VAR material outperformed all alloys tested with a measured 10(7)-fatigue alternating strain limit of 0.32% for wire and 1.75% for diamonds. Process-Optimized VIM+VAR material was only slightly inferior to the High Purity VAR with a diamond alternating bending strain limit of 1.5%. These two "second generation" Nitinol alloys demonstrated approximately a 2× increase in 10(7)-cycle fatigue strain limit compared to all of the Standard-grade Nitinol alloys (VAR, VIM, and VIM+VAR) that demonstrated virtually indistinguishable fatigue performance. This statistically-significant increase in fatigue resistance in the contemporary alloys is ascribed to smaller inclusions in the Process-Optimized VIM+VAR material, and both smaller and fewer inclusions in the High-Purity VAR Nitinol.