(A. Rosen, F. Kralick)

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Abstract: Elevation of the Intracranial Pressure (ICP) is one of the most important issues in neurosurgery and neurology in clinical practice. ICP monitoring is utilized in many pathological conditions of the brain including trauma, neoplasm, and infection, and is the most sensitive indication of shunt failure for the treatment of hydrocephalus. The current method of ICP measurement requires cables that emanate from the scalp that tether the patient to monitors in an ICU setting. This is associated with patient morbidity, most commonly infection and mortality. A wireless, completely implantable device, operating at Industrial-Scientific-Medical (ISM) band of 2.4 GHz was developed and tested. In-vitro and in-vivo evaluations were performed to demonstrate the feasibility of microwave pressure monitoring through scalp, device integrity over a long period of time, and repeatability of pressure measurements. The present prototype is implanted in a burr hole (12 mm) drilled in the skull during a neurosurgical procedure. A patient in need of such a monitor undergoes a surgery for the underlying cause of elevated ICP. Thus, no additional procedure is required for the device implantation. This device will be miniaturized further for a possibility of implantation at the bed-side. In-vitro studies were conducted for a month to gauge the device reliability in terms of its performance and integrity in a medium emulating the biological environment. Long term in-vitro and in-vivo (canine) studies for up to a year will be conducted to evaluate the device performance. The goal of this research activity will be to collect data on the reliability of this device which will be a part of the statistical results needed to apply for FDA approval for performing clinical trials. The implantation of our proposed device in cases of chronic conditions (like hydrocephalus) will have a significant impact on the currently required post-operative medical cost.