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Nitinol Release of Nickel under Physiological Conditions: Effects of Surface Oxide, pH, Hydrogen Peroxide, and Sodium Hypochlorite

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Abstract

Nitinol is a nickel–titanium alloy widely used in medical devices for its unique pseudoelastic and shape-memory properties. However, nitinol can release potentially hazardous amounts of nickel, depending on surface manufacturing yielding different oxide thicknesses and compositions. Furthermore, nitinol medical devices can be implanted throughout the body and exposed to extremes in pH and reactive oxygen species (ROS), but few tools exist for evaluating nickel release under such physiological conditions. Even in cardiovascular applications, where nitinol medical devices are relatively common and the blood environment is well understood, there is a lack of information on how local inflammatory conditions after implantation might affect nickel ion release. For this study, nickel release from nitinol wires of different finishes was measured in pH conditions and at ROS concentrations selected to encompass and exceed literature reports of extracellular pH and ROS. Results showed increased nickel release at levels of pH and ROS reported to be physiological, with decreasing pH and increasing concentrations of hydrogen peroxide and NaOCl/HOCl having the greatest effects. The results support the importance of considering the implantation site when designing studies to predict nickel release from nitinol and underscore the value of understanding the chemical milieu at the device–tissue interface.

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Acknowledgements

Funding for this work was provided by the U.S. Food and Drug Administration Center for Devices and Radiological Health. The project was supported by appointments of authors (H.S., P.A.T.) to the Research Participation Program administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and the U.S. Food and Drug Administration. The authors would like to thank Dr. Katherine Vorvolakos for review of this manuscript.

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    Authors and Affiliations

    1. Division of Biology, Chemistry, and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993-0002, USA

      Eric M. Sussman, Paul A. Turner, David M. Saylor, David D. Simon, Pavel Takmakov, Hainsworth Y. Shin & Dianne E. Godar

    2. Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993-0002, USA

      Huiyu Shi, Jason D. Weaver, Shiril Sivan & Matthew A. Di Prima

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    This invited article is part of a special topical focus in the journal Shape Memory and Superelasticity on Cardiovascular Nitinol Medical Devices. The issue was organized by Dr. Srinidhi Nagaraja, G.RAU, Inc. and Dr. Harshad M. Paranjape, Confluent Medical Technologies, Inc.

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    Sussman, E.M., Shi, H., Turner, P.A. et al. Nitinol Release of Nickel under Physiological Conditions: Effects of Surface Oxide, pH, Hydrogen Peroxide, and Sodium Hypochlorite. Shap. Mem. Superelasticity 8, 98–106 (2022). https://doi.org/10.1007/s40830-022-00364-3

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