Implantable electrical feedthrough reliability demonstration testing and life prediction

An accelerated life test has been developed for rapidly evaluation of implantable medical device feedthrough (FT) hermeticity performance. The accelerated test allows for process and/or design optimization in order maximize characterize the hermeticity longevity in a relative short period of time. A zero failure reliability demonstration approach has been developed to demonstrate the new FT designs met the reliability goals using quantitative accelerated life tests. FT design A, has demonstrated a reliability level of R>;0.9994 at 95% confidence with respect to 20 year 37°C hermetic life based on zero failure reliability demonstration testing (150°C, 175°C and 200°C tests). FT design B has demonstrated a reliability level of R>;0.9999 at 95% confidence with respect to 5 year 37°C hermetic life based on zero failure reliability demonstration approach (150°C and 175°C tests) or modeling failure data (200°C tests).