Self-expanding vascular implants are typically manufactured from Nitinol tubing, using laser cutting, shape setting, and electropolishing processes. The mechanical and fatigue behavior of those devices are affected by the raw material and its processing such as the melting process and subsequent warm and cold forming processes. Current trends focus on the use of raw material with fewer inclusions to improve the fatigue performance. Further device miniaturization and higher fatigue life requirements will drive the need toward smaller inclusions and new manufacturing methods. As published previously, the high-cycle fatigue region of medical devices from standard processed Nitinol is usually about 0.4-0.5% half-alternating strain. However, these results highly depend on the ingot and semi-finished materials, the applied manufacturing processes, the final dimensions of test samples, and applied test methods. Fabrication by sputter deposition is favorable, because it allows the manufacturing of micro-patterned Nitinol thin-film devices without small burrs, heat-affected zones, microcracks, or any contamination with carbides, as well as the fabrication of complex components e.g., 3D geometries. Today, however, there is limited data available on the fatigue behavior for real stent devices based on such sputter-deposited Nitinol. A detailed study (e.g., using metallographic methods, corrosion, tensile, and fatigue testing) was conducted for the first time in order to characterize the micro-patterned Nitinol thin-film material.
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The authors would like to thank Dr. Markus Wohlschlögel, Michael Quellmalz, Hannes Feldmann and Marcel Brock at Admedes Schuessler GmbH and Christoph Bechtold from Acquandas GmbH for technical discussion as well as sample fabrication.
This article is an invited paper selected from presentations at the International Conference on Shape Memory and Superelastic Technologies 2013, held May 20-24, 2013, in Prague, Czech Republic, and has been expanded from the original presentation.
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Siekmeyer, G., Schüßler, A., de Miranda, R.L. et al. Comparison of the Fatigue Performance of Commercially Produced Nitinol Samples versus Sputter-Deposited Nitinol. J. of Materi Eng and Perform 23, 2437–2445 (2014). https://doi.org/10.1007/s11665-014-1101-x
- fatigue performance
- nitinol tubing
- vascular implants