A Small, Portable, and Powerless Sterilization System for Medical/Dental Instruments

The U.S. military has a significant need to sterilize medical and dental instruments in environments where standard non-portable, power-consuming sterilization methods are limited and/or unavailable. Lynntech proposes to develop a small, light-weight, and powerless steam sterilization system for field use. The system includes small, disposable heating/cooling cartridges that exploit well-known exothermic and endothermic reactions. Once initiated, the cartridge heats the instruments to the required sterilization temperature and after the appropriate amount of time has elapsed, an endothermic cooling reaction is automatically triggered within the cartridge to cool the instruments to a usable temperature, thus minimizing sterilization cycle time. In Phase I, we will select optimal exothermic and endothermic reactions based on the weight-energy ratio, cost, safety, and environmental considerations, as well as demonstrate the sterilization of instruments inoculated with the standard FDA test organisms, B. atrophaeus and G. stearothermophilus spores. In Phase II, we will assemble a deployable prototype sterilization system optimized for performance, size, weight, and ruggedness in accordance with feedback from the COTR. The development of the system and associated experiments will be performed in accordance with FDA's 510(k) application submission requirements which will facilitate the transition of the technology to a suitable Phase III partner.