An integration concept for an implantable biosensor for the continuous monitoring of blood sugar levels is presented. The system architecture is based on technical modules used in cardiovascular implants in order to minimize legal certification efforts for its perspective usage in medical applications. The sensor chip operates via the principle of affinity viscometry, which is realized by a fully embedded biomedical microelectromechanical systems (BioMEMS) prepared in 0.25-µm complementary metal–oxide–semiconductor (CMOS)/BiCMOS technology. Communication with a base station is established in the 402–405 MHz band used for medical implant communication services (MICS). The implant shall operate within the interstitial tissue, and the hermetical sealing of the electronic system against interaction with the body fluid is established using titanium housing. Only the sensor chip and the antenna are encapsulated in an epoxy header closely connected to the metallic housing. The study demonstrates that biosensor implants for the sensing of low-molecular-weight metabolites in the interstitial may successfully rely on components already established in cardiovascular implantology.
A microelectronic biosensor was subjected to in vivo exposure by implanting it in the vicinity of m. trapezii (Trapezius muscle) from cattle. The implant is intended for the continuous monitoring of glucose levels, and the study aimed at evaluating the biostability of exposed semiconductor surfaces. The sensor chip was a microelectromechanical system (MEMS) prepared using 0.25 µm complementary metal–oxide–semiconductor CMOS/BiCMOS technology. Sensing is based on the principle of affinity viscometry with a sensoric assay, which is separated by a semipermeable membrane from the tissue. Outer dimensions of the otherwise hermetically sealed biosensor system were 39 × 49 × 16 mm. The test system was implanted into cattle in a subcutaneous position without running it. After 17 months, the device was explanted and analyzed by comparing it with unexposed chips and systems. Investigations focused on the MEMS chip using SEM, TEM, and elemental analysis by EDX mapping. The sensor chip turned out to be uncorroded and no diminishing of the topmost passivation layer could be determined, which contrasts remarkably with previous results on CMOS biosensors. The negligible corrosive attack is understood to be a side effect of the semipermeable membrane separating the assay from the tissue. It is concluded that the separation has enabled a prolonged biostability of the chip, which will be of relevance for biosensor implants in general.
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