Implantable and ingestible medical devices (IIMDs): optimal-performance-oriented design and evaluation methodology (DEM-II-MED)

Biotelemetry permits the measurement of physiological signals at a distance. Its latest application is in implantable and ingestible medical devices (IIMDs). In this project, a Design-and-Evaluation closed-loop Methodology for biotelemetry-telemedicine-integrated systems of antenna-enabled IIMDs (DEMIIMD) is implemented. The DEMIIMD consists of five interconnected design-and-evaluation steps (1. data/power circuit, 2. IIMD-antenna, 3. biotelemetry link, 4. patient safety, 5. telemedicine link), and one overall evaluation step. Application-specific requirements must be taken into account at all steps to render the design suitable for the application at hand. Studies will be developed in six workpackages (WPs). The first five WPs will address research issues raised within the first five steps of the DEMIIMD, respectively. Emphasis will be on IIMD-antenna design, biotelemetry link modeling and performance, and safety. Extensive numerical and in-vitro/in-vivo studies will be performed. Electronics and biotelemetry-telemedicine-integration issues will also be addressed. The sixth WP will be devoted to numerical and in-vitro studies to validate the DEMIIMD within the framework of a novel system for wireless intracranial pressure (ICP) monitoring, as an alternative to the traditional wired approaches. Novelty lies in the proposal of the DEMIIMD as a standardized procedure which addresses interconnecting interdisciplinary challenges to design and test integrated systems for antenna-enabled IIMDs. Significant progress beyond the state of the art will be provided, with the highlights being: optimized design algorithms for miniature IIMD-antennas, reliable antenna testing, thermal/multi-source/in-vitro dosimetry for IIMDs, novel methods to assess tissue temperature rise, in- and out-of-body channel modeling, biotelemetry-telemedicine-integration, and a novel wireless approach to ICP monitoring.