The broader impact and commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to reduce the risk of patients experiencing a severe drop in body temperature during surgery, known as inadvertent perioperative hypothermia (IPH). In the United States, 57.5 million procedures are performed annually with significant risk of IPH and an estimated 22 million surgical patients develop clinical complications associated with IPH. IPH leads to increased wound infections, blood loss, cardiac problems, increased use of mechanical ventilation, and longer stays in hospital, contributing to 1 million excess inpatient days and $1.6 billion in yearly costs. The proposed technology will develop a novel device to prevent IPH, saving an estimated $2,000-$3,500 per patient or $1 billion. This Small Business Innovation Research (SBIR) Phase I project aims to create a body heat transfer model that accurately integrates the novel device with a tissue model of the lower limb. The resulting model will enable in silico evaluation of device performance (heat output), efficacy (heat transfer), and safety (burn risk) across a broad clinical setting (expanded surgical procedures and patient demographics). We will collect clinical data from a proof-of-concept feasibility study to create and validate a model. Further simulation in support of prototype development efforts enable the optimization of critical parameters. Physical prototypes (including sub-components) will be developed and manufactured based on the optimized design. Prototypes will be evaluated for thermal performance under controlled bench-top tests, with empirical results compared to expected values generated by the model. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
