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Rotary Bend Fatigue of Nitinol to One Billion Cycles

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Abstract

Nitinol implants, especially those used in cardiovascular applications, are typically expected to remain durable beyond 108 cycles, yet literature on ultra-high cycle fatigue of nitinol remains relatively scarce and its mechanisms not well understood. To investigate nitinol fatigue behavior in this domain, we conducted a multifaceted evaluation of nitinol wire subjected to rotary bend fatigue that included detailed material characterization and finite element analysis as well as post hoc analyses of the resulting fatigue life data. Below approximately 105 cycles, cyclic phase transformation, as predicted by computational simulations, was associated with fatigue failure. Between 105 and 108 cycles, fractures were relatively infrequent. Beyond 108 cycles, fatigue fractures were relatively common depending on the load level and other factors including the size of non-metallic inclusions present and the number of loading cycles. Given observations of both low cycle and ultra-high cycle fatigue fractures, a two-failure model may be more appropriate than the standard Coffin-Manson equation for characterizing nitinol fatigue life beyond 108 cycles. This work provides the first documented fatigue study of medical grade nitinol to 109 cycles, and the observations and insights described will be of value as design engineers seek to improve durability for future nitinol implants.

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Data Availability

The experimental fatigue life dataset is provided with this published article as a supplementary file. All other datasets are available from the corresponding author on reasonable request.

Notes

  1. \(\Phi \left(x\right)=P\left(Z\le x\right)=\frac{1}{\sqrt{2\pi }}\underset{-\infty }{\overset{x}{\int }}\mathrm{exp}\left\{-\frac{{u}^{2}}{2}\right\}\mathrm{d}u.\)

  2. Due to numerical convergence issues, the parameter \({\varepsilon }_{50}\) was “hard” set to 0.56% strain rather than identified using maximum likelihood techniques. This choice for \({\varepsilon }_{50}\) was based on inspection of the observed cycles to fracture data. Samples run at this nominal strain level of 0.56% saw roughly equal proportions fracture before and after 10 million cycles. As a result of setting the parameter, the fit of the \({\varepsilon }_{50}\) parameter may not be optimal, and the confidence bounds on \({\varepsilon }_{50}\) could not be calculated. Work to improve the numerical algorithm to treat \({\varepsilon }_{50}\) as a true model parameter is ongoing.

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Acknowledgements

Many individuals have supported this research and we would specifically like to recognize the efforts of Burns Doran, Tony Bauer, and Chiang Xiong in making the specimens and running the tests at BSC as well as Terry Woods, Charlie Yongpravat, Finn Donaldson, and Matthew Di Prima from FDA for their thoughtful discussions throughout the project. This work was performed under a Research Collaborative Agreement between FDA, Medtronic, and Boston Scientific and was funded by the U.S. FDA Center for Devices and Radiological Health (CDRH) Critical Path program. The research was supported in part by an appointment to the Research Participation Program at the U.S. FDA administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and FDA. The findings and conclusions in this article have not been formally disseminated by the U.S. FDA and should not be construed to represent any agency determination or policy. The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services.

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Authors and Affiliations

  1. U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA

    J. D. Weaver, G. M. Sena, K. I. Aycock & S. Sivan

  2. Medtronic, Mounds View, MN, USA

    A. Roiko & W. M. Falk

  3. Boston Scientific (BSC), Maple Grove, MN, USA

    B. T. Berg

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  1. J. D. Weaver
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Correspondence to J. D. Weaver.

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This article is an invited submission to Shape Memory and Superelasticity selected from presentations at the Shape Memory and Superelastic Technology Conference and Exposition (SMST2022) held May 16–20, 2022, at The Westin Carlsbad Resort, San Diego, California, and has been expanded from the original presentation. The issue was organized by Dr. Srinidhi Nagaraja, G.RAU, Inc. and Dr. Ashley Bucsek, University of Michigan.

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Weaver, J.D., Sena, G.M., Aycock, K.I. et al. Rotary Bend Fatigue of Nitinol to One Billion Cycles. Shap. Mem. Superelasticity 9, 50–73 (2023). https://doi.org/10.1007/s40830-022-00409-7

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