This proposal presents Phase 1 of the plan of Mercury Biomed, LLC for commercializing the new and innovative WarmSmart technology to more effectively keep patients warm during anesthetized surgery. The WarmSmart technology is based on IP licensed from the University of Texas at Austin, who is the academic partner for this STTR proposal. WarmSmart embodies several breakthrough concepts in bioheat transfer to manage core temperature. We anticipate a cost competitive technology that will offer equivalent or superior thermal performance than existing technologies with multiple unique advantages and that will be much more convenient, simple, and safe to use. The most widely applied existing technology for keeping patients warm during surgery uses heating applied over large areas of the body surface via forced convection of hot air through an outer bag placed onto the patient. A recent comprehensive study shows that this technology failed to maintain patients above the minimum acceptable core temperature throughout surgeries in 2/3 of the cases, plus it occupies large areas of the body surface, placing unnecessary restrictions on access to the patient during surgery. WarmSmart requires access to only the hands and feet where uniquely high rates of blood flow can occur through glabrous skin, constituting the body's already existing high performance heat flow pathway between the surface and the core. Not only does WarmSmart add heat more effectively to combat drops in core temperature, in doing so it blocks and reverses the primary heat loss process caused by anesthesia, making it doubly effective. The project will have two specific aims to prepare for conducting clinical trials with WarmSmart in Phase 2. In SA #1 an existing thermoelectric powered device available to Mercury will be redesigned and reengineered to meet the minimum of 75W heating capacity. The heart of the existing technology is a thermoelectric energy source that can provide a water flow to heating pads applied to the hands and feet at precisely regulated temperatures. Enhancements will include a more efficient design for the water flow heat exchangers and a higher flow capacity water pump. New water flow pads will incorporate state-of-the-art heat exchanger design principles. A new operator interface will be created based on input from our advisory panel of anesthesiologists to ensure practical acceptance of WarmSmart. In SA #2 working prototypes of WarmSmart will be designed, fabricated, and experimentally verified for thermal performance. UT will conduct scientific and initial human heat transfer analysis, and Mercury will perform a 14-point verification protocol for final refinement in preparation for clinical trials and subsequent FDA registration. The deliverable outcome is ten tested WarmSmart devices that can be applied in clinical trials with our medical collaborators at Cleveland Clinic.
WarmSmart is a new concept in devices for perioperative warming of anesthetized patients to more effectively keep them above the safe minimum core body temperature and to be more compatible for use with surgical procedures. WarmSmart will make the management of anesthesia safer and more convenient, and will provide better results for patient recovery from surgery.