The opportunity exists for greatly improving the state of the art of external uterine contraction monitoring through the development of an innovative concept for a new contraction sensor (tocotonometer). Uterine contraction monitoring is extremely important during labor and delivery, as it provides quantitative data for the diagnosis of fetal distress, and for the regulation of therapeutic measures. Current external uterine contraction monitoring methods are regarded as qualitative, marginally reliable representations of intrauterine pressure (IUP) monitoring methods. In addition, current tocotonometers suffer from problems of accuracy, reliability, patient comfort, and difficulty in use and cleaning.
The specific aim of the proposal is to complete the product development of a reliable, disposable uterine contraction sensor. An innovative concept for a new contraction sensor led to the design, construction, and clinical testing of product prototypes during Phase I of the grant. During Phase II, the product version of the disposable air bladder and its associated electronic interface module will be designed, prototyped, bench tested, and clinically tested. Following successful testing, a pre-production run of 100 disposables and 10 interfaces will be produced and qualified. The necessary manufacturing documentation will be prepared, and the first production run will be produced, qualified, and released for sale.
