E. A. Jacuzzi, R. G. Lipmyer, InnoMotus LLC, Ann Arbor, MI
The authors have created a novel thermal and sterilization cycling counter with functionality based on shape-memory Nitinol, and an elegant, yet simple design. The device is a response to the burgeoning market for reuse of single-use medical devices by hospitals. Tracking the number of times a device has been cycled has proven challenging because of the number of processes, people, and companies involved in re-sterilizing this equipment. Presently, all other methods to achieve this require significant human intervention. The device is capable of being configured in either a linear or circular design depending on the application required. The design can be configured to any number of cycles, and the size can be varied from as small as ¼” square to as large as desired. The authors plan to produce an initial prototype run by January to assess manufacturing techniques for mass production and begin integration with specific medical instruments.
Summary: A novel sterilization counter has been developed using shape memory Nitinol for use in the medical reuse industry. The need for such a device stems from clinical reuse of single use devices, which is a double digit growth industry, and the need to accurately track sterilization cycles to determine safety and efficacy. The device is competely passive and can be configured in a linear or circular pattern, with a cycle count from 2-5000 depending on the application. The extremely small size of the hermetically sealed package allows for integration with a multitude of devices.
