Design, development and performance of a Fe-Mn-Si-Cu alloy for bioabsorbable medical implants.

Abstract

Bioabsorbable metallic alloys constitute a very challenging and innovative field, mainly aimed to develop the next generation of temporary medical implants. Degradation data, biological in vitro and in vivo tests are of major importance in particular for complex alloys, in which the individual element additions could enhance material performance and add functionalities. In this study, a novel Fe-Mn-Si-Cu alloy was carefully designed for vascular and blood-contact applications, and its microstructure, mechanical behavior, degradation behavior and biological performances were investigated accordingly. In previous studies, Mn and Si were found to be suitable elements to effectively enhance mechanical properties and accelerate corrosion rate in simulated body fluid. Cu was added for further grain refinement by the formation of small Cu-rich particles, potentially impacting mechanical properties and degradation behavior. In addition, the feasibility of inducing antibacterial effects in a Fe-Mn-Si-Cu alloy with low Cu content was investigated. The alloy was prepared firstly on a small scale by vacuum arc remelting, then on a larger scale by vacuum induction melting and converted into sheets by conventional thermomechanical processing techniques. Heat treatments were explored to find optimal microstructure conditions. The results confirm promising mechanical, degradation and biological performance in testing the material in in vitro conditions, showing that the degradation products are neither systematically cytotoxic nor have any hemotoxic effects. On the other hand, the expected antibacterial effects could not be confirmed.