Method for Fabricating Miniaturized NiTi Self-Expandable Thin Film Devices with Increased Radiopacity

Abstract

Nitinol is the material of choice for many medical applications, in particular for minimally invasive implants due to its superelasticity and biocompatibility. However, NiTi has limited radiopacity which complicates positioning in the body. A common strategy to increase the radiopacity of NiTi devices is the addition of radiopaque markers by micro-riveting or micro-welding. The recent trend of miniaturizing medical devices, however, reduces their radiopacity further, and makes the addition of radiopaque markers to these miniaturized devices difficult. NiTi thin film technology has great potential to overcome such limitations and to fabricate new generations of miniaturized, self-expandable NiTi medical devices with additional functionalities, such as structured multilayer devices with increased radiopacity. For this purpose, we have produced superelastic thin film NiTi samples covered locally with Tantalum structures of different thickness and different shape. These multilayer devices were characterized regarding their mechanical and corrosion properties as well as their X-ray visibility. The superelastic behavior of the underlying NiTi layer is impeded by the Ta layer, and shows therefore a dependence on the Tantalum patterning geometry and thickness. No delamination was observed after mechanical and corrosion tests. The multilayers reveal excellent corrosion resistance, as well as a significant increase in radiopacity.