Portable Body Temperature Conditioner.

摘要

Many patients become hypothermic after severe injury due to environmental exposure during transport. These patients also have decreased thermoregulation due to blood loss. Normal core body temperature is defined as 37 deg C and core body temperature below 35 deg C and above 40 deg C is defined as hypothermia and hyperthermia respectively. Studies have shown much better outcomes for patients with either trauma or hypothermia compared to patients with both trauma and hypothermia. Additionally, studies have shown that decreasing the hyperthermic patient s core body temperature rapidly to 38 deg C lowers the incidence of complications and the risk of death. Currently, one of the most effective treatments for dysthermic patients involves the use of active convective/conductive heating/cooling devices. However, current devices require heavy or bulky equipment not suitable for military applications. Rocky Research and University of Nevada School of Medicine (UNSOM) have developed a novel Portable Body Temperature Conditioner (PBTC). This portable device is designed to promote normothermic conditions in injured or ill patients under typical conditions encountered in the field and during medical evacuation when access to electrical power is not available. The heating/cooling system has been designed to maximize efficiency allowing for a reduction in component and battery weight. Patient simulation testing was performed to evaluate thermal load and efficacy of PBTC with the use of a thermal manikin. Quality system regulation (QSR) and several design phase documents were started that are required for future FDA 510(k) submission of this medical device. The PBTC prototype allows thermal management therapy to be delivered to patients in a previously unattainable manner.