Irradiation-Assisted Stress-Corrosion Cracking of Nitinol During eBeam Sterilization

Abstract

Medical device fractures during gamma and electron beam (eBeam) sterilization have been reported. Two common factors in these device fractures were a constraining force and the presence of fluorinated ethylene propylene (FEP). This study investigated the effects of eBeam sterilization on constrained light-oxide nitinol wires in FEP. The goal was to recreate these fractures and determine their root cause. Superelastic nitinol wires were placed inside FEP tubes and constrained with nominal outer fiber strains of 10, 15, and 20%. These samples were then subjected to a range of eBeam sterilization doses up to 400 kGy and compared with unconstrained wires also subjected to sterilization. Fractures were observed at doses of >100 kGy. Analysis of the fracture surfaces indicated that the samples failed due to irradiation-assisted stress-corrosion cracking (IASCC). This same effect was also observed to occur with PTFE at 400 kGy. These results suggest that nitinol is susceptible to IASCC when in the presence of a constraining stress, fluorinated polymers, and irradiation.