Surface finishing of Nitinol for implantable medical devices: A review

Nitinol (NiTi), a nickel-titanium alloy, has been used for various cardiovascular, orthopedic, fracture fixation, and orthodontic devices. As with most other metallic biomaterials, the corrosion resistance and biocompatibility of NiTi are primarily determined by the properties of the surface oxide layer such as thickness, chemical composition, structure, uniformity, and stability. Currently, a number of finishing methods are used to improve the properties of surface oxide of NiTi with an ultimate goal to produce a defect-free, impurity-free, thin homogeneous oxide layer that is stable and composed of only titanium dioxide (TiO₂ ) with negligible amount of Ni species. This review discusses the effects of various surface finishing methods such as mechanical polishing, electropolishing, magnetoelectropolishing, heat treatments at different temperatures, passivation, chemical etching, boiling in water, hydrogen peroxide treatment, and sterilization techniques (steam autoclave, ethylene oxide, dry heat, peracetic acid, and plasma-based treatments) on the properties of a surface oxide layer and how it impacts the corrosion resistance of NiTi. Considering the findings of the literature review, a checklist has been provided to assist with choosing finishing/sterilization methods and relevant rationale and recommendations to consider when selecting a surface finishing process for NiTi used in implantable medical devices.