Deployable Closed-Loop Anesthesia System

The AutoTIVA system, to be developed under this program, comes as an answer to the Army requirement for a "deployable automated analgesia and anesthesia system".The AutoTIVA device concept is akin to that of an autopilot for anesthesia and sedation, where the administration of both intravenous analgesics and hypnotics are adjusted continuously in real-time, to drive and maintain patients in a pre-defined cortical activity level.This system integrates a clinical-grade 2-channel electroencephalographic device to acquire the patient brainwaves, and our proprietary WAVcns analysis to calculate the level of cortical activity from the acquired signals. The proprietary WAVcns index is used as a feedback quantity to regulate the infusion rates of both analgesics and hypnotics. Drug delivery is ensured via two off-the-shelf syringe infusion pumps directly connected to the AutoTIVA platform.The proposed Phase II program builds on our Phase I results, transitioning from a prototype-level system to a first commercial device deployable at the outset of the program. In addition, further enhancements of the system user interface and control mechanism will be made to address some of the limitations identified in the Phase I, and based on the feedback from our Clinical Advisory Board.