On the Stability of Silicone-Encapsulated CMOS ICs for Active Implantable Devices: 4.3 Years of Accelerated Life Testing

Abstract

The reliability of polymer-encapsulated CMOS integrated circuits (ICs) is critical for the development of miniaturised active implantable medical devices (AIMDs). Traditional hermetic packaging methods become impractical as implant sizes decrease, necessitating alternative methods of protection from body fluids. This study evaluates the long-term stability of silicone-encapsulated CMOS ICs through accelerated life testing using electrical impedance spectroscopy (EIS) and visual inspection. CMOS interdigitated combs (IDCs) were encapsulated in medical grade silicone rubber, subjected to immersion in phosphate-buffered saline (PBS), and tested at elevated temperatures (47{degrees}C, 67{degrees}C, and 87{degrees}C) under both 5V DC and biphasic voltage biases for up to 4.3 years. Remarkably, no insulation failures were observed in the IDCs, with no significant water ingress detected through impedance changes. Failures at the ICs were limited to wire bond open-circuits, though there was some pad discolouration/corrosion. Other failures were elsewhere, not at the ICs. This highlights the stability of modern silicon oxide/silicon nitride bilayer passivation when encapsulated in adhesive silicone rubber. Visual analysis revealed occasional solder and aluminium pad corrosion, particularly at higher temperatures, but these changes did not correlate with EIS failures. The findings suggest that silicone encapsulation, combined with passivation and shielding strategies, enables long-term IC reliability in biofluid environments. To our knowledge, this paper presents the longest reported accelerated ageing study of test structures for implantable devices, laying the groundwork for the integration of silicone-encapsulated ICs into next-generation chip-scale bioelectronic implants.