Intraoperative Brain Dysfunction Monitor/Detector
Small Business Information
CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE, CLEVELAND, OH, 44103
AbstractDESCRIPTION (provided by applicant): In this program, we propose to develop an advanced intraoperative wireless monitor for the early detection of brain dysfunction and ischemia that would be particularly suited for cardiovascular surgeries. Cardiovascular surgeries are procedures particularly prone to intra- and postoperative brain injury. One of the major difficulties faced by the surgical team is the eventual interruption of blood flow to the brain following, for example, aortic or carotid clamping. This can result in a critical drop in the oxygenation level in the brain - brain ischemia which seriously affects the neurologic outcome (cognitive impairment, seizures, loss of motor/speech/vision functions, and ultimately, death). Our proposed intraoperative brain dysfunction/detector will quantify and analyze cortical activity of the patient by real-time analysis of EEG acquired from multiple scalp locations during the surgical procedure. The proposed system combines state-of-the art miniature wireless bio-telemetry technology of the Cleveland Medical Devices Inc. with an enhanced multi-channel version of a novel and very promising wavelet-based algorithm recently developed by the PI for quantitative monitoring of anesthetic depth based on a single frontal EEG channel. The multi-channel cortical activity indexes to be developed in this program will present a real-time status of the global brain state. In addition, these indexes will be employed by a warning algorithm module, which will enable an alarm based on several predetermined patterns of cortical activity indicative of local brain dysfunction. Toward the end of Phase I, the proposed system will undergo an extensive clinical evaluation at the operating rooms of two medical centers.
* information listed above is at the time of submission.