VIVONICS INC — Department of Defense SBIR Phase II: An automated, closed loop individualized system for administration of analgesic and anesth

Description

An automated, closed loop individualized system for administration of analgesic and anesthetic medication to patients is proposed in order to ensure vigilant, optimized care, especially in special circumstances when a large number of trauma patients must be treated simultaneously by a limited number of medical personnel. The result is improved pain management, safety, outcome, and reduced complications such as post-traumatic stress disorder (PTSD). The Deployable Analgesia Administration System (DAAU) optimally sets the infusion rate and rapidly delivers an initial bolus, based on a population pharmacokinetic approach and employs feedback from vital signs monitoring and automated mental status assessment, as well as a novel means to actively query the brain to monitor analgesic/anesthetic depth, in order to safely oversee infusion. A staged product development is proposed, moving from automatic analgesia/anesthesia delivery to the conscious patient, to infusion of medication into patients whose level of consciousness is diminished either by their injuries or requirement for surgical depth of anesthesia. Phase II consists of (1) verification of biomarkers which reflect patient status and their incorporation into medication infusion algorithms, (2) construction and verification of function of a Deployable Autonomous Analgesia Unit (DAAU) prototype, (3) preclinical verification of safety of DAAU in established animal models receiving analgesia/anesthesia from the DAAU, (4) further investigation of a noninvasive sensor for monitoring analgesic/anesthetic depth (as the DAAU adjusts infusion), (5) risk management, and (6) testing to assess ease of use and setup.