Although interest in implantable telemetry has grown substantially during this decade, a major technical challenge remains: increasing the operating range of the telemetry link while miniaturizing the implant body. Under this "Fast-Track" project, we propose to establish feasibility (Phase I) and then develop a prototype (Phase II) of an ultraminiature implantable telemetry device for monitoring pressure, heart rate, and temperature. The initial focus will be on preterm labor and post- surgical monitoring of the fetus following fetal surgery. Advances in preterm labor assessment and monitoring of fetal vital signs will reduce the significant neonatal and long-term health problems that affect thousands and cost billions annually. In collaboration with Dr. Scott Adzick, a pioneer in preterm labor management and fetal surgery, Data Sciences will address the key challenges of 1) increasing the range for bidirectional communications with the implanted device, and 2) size reduction of the electronics and battery. The device will leverage core patented technology and know-how that Data Sciences Int'l (DSI) has commercialized for telemetric monitoring of blood pressure. A successful Phase I feasibility demonstration will lead to an accelerated Phase II focused on prototype fabrication for in vivo testing. PROPOSED COMMERCIAL APPLICATIONS: As envisioned, this novel ultraminiature monitoring device has a number of potential applications in clinical medicine, including fetal (post-surgical) and obstetric monitoring, long-term ambulatory cardiovascular assessment, and monitoring of life- threatening hypertension. Advances realized will also be applicable to DSI products designed for long-term telemetry for small-animal studies. DSI has a proven track record of commercializing SBIR technologies and is an SBIR Tibbetts Award Winner.
