Implantable biomedical sensor array with biocompatible hermetic encapsulation

Abstract. The treatment of metabolic diseases, such as diabetes mellitus, requires sensitive measuring systems. These should be able to detect the different metabolism-related parameters (blood glucose level, pH, pCO₂) simultaneously and continuously. A new approach is an implantable wireless sensor microarray consisting of several hydrogel-based piezoresistive sensors that can provide an on-line monitoring of physiological parameters in the human body fluid. The specifically customized stimuli-responsive hydrogels enable the development of reliable biosensors for different analytes. In this regard, the on-line medical diagnostics attracts the main interest. The developed sensor system and its encapsulation should correspond to high requirements on the biocompatibility of implants according to the medical standard DIN EN ISO 10993-5. A multi-layer sensor encapsulation consisting of parylene C and amphiphilic block copolymers was proposed for subcutaneous implants and characterized using contact angle measurements and X-ray photoelectron spectroscopy. In vitro studies with model cells showed no cytotoxicity of the polyethylene glycol-based block copolymers. In order to understand the behavior of implants under physiological conditions, the interaction of the implant surface with biological specimen like proteins is discussed, taking into account the possible protein adsorption on the implant surface due to tissue inflammation around the implant, which should be minimized. Finally, the biocompatibility of the developed sensor system was studied to prove the suitability of the approach.