Testing and Commercialization of a Superior Device to Maintain Perioperative Normothermia In Anesthetized Patients

Project SummaryAbstractThis proposal presents Phase II of Mercury Biomedandapos s plan for commercializing the new and innovative WarmSmart technology to more effectively keep surgical patients normothermicWarmSmart embodies several breakthrough concepts in bioheat transfer to manage core temperatureWe are building a costcompetitive patient warming technology that will be superior to existing technologies while being more convenienteasy to useand safeWell established clinical evidence shows that unwarmed anesthetized patients rapidly become aboutC hypothermicWe have also shown in many randomized trials that this degree of hypothermia promotes surgical site infectionimpairs drug metabolismand increases blood loss and transfusion requirementThe most widely applied technology for keeping patients warm during surgery uses heating applied over large areas of the body surface via forced convection of hot air through a cover surrounding patientsA recent study of surgical patients shows that this technology fails to keep patients above the minimum acceptable core temperatureCin two thirds of patientsForced air covers also occupy large fractions of the body surface which can restrict access to patients during surgeryWarmSmart requires access to only the hands and feet where uniquely high rates of blood flow can occur through glabrous skinThe Division of PharmacologyPhysiology and Biological Chemistry has a list of approved topics that includedevelopment oftreatments involved in peri operative conditionsand this project advances those objectivesIn Phase Iwe made considerable advances in both the technology and understanding of the human physiology related to the technologyBoth Phase I specific aims were accomplished throughexecuting physiological experiments in humans that provided conclusive evidence that our system reduces the vasoconstriction thresholdcore temperature triggering thermoregulator vasocontrictionin patients subjected to a cooling stimulusandbuilding a fully functioning working prototype of a solid state system that uses Positive Temperature Coefficient heating apparatus at the glabrous skin region to efficiently transfer heat to the human bodyPhase II of the project will have five specific aims to prepare for the commercialization of the WarmSmart devicemeasure the physiological sensitivity of the Selective Thermal StimulationTemperatureCycle timesSTS Locationdetermine the rate at which the WarmSmart system can warm anesthetized patientstest the hypothesis that the WarmSmart systemandapos s performance is non inferior to current forced air warming solutionsdesign and develop a commercializable WarmSmart systemandsecure FDA approval for the WarmSmart system Project Narrative Mercury Biomed seeks to continue clinical validationdevelopment and application for FDA approval of its novel peri operative warming technology to provide anesthetized patients and their operating room clinical staff with a welcomed alternative to current patient warming technologies