Women’s Health

Abstract

 Biomarkers available in the vaginal canal can provide valuable and accurate information for reproductive health. Accurate monitoring can provide insights into fertility, cycle tracking, and infection detection. This development includes an intravaginal sensor that measures temperature and pH levels. Data would be available on a HIPAA complaint, encrypted app for patient and clinician use. Data is collected each morning to ensure the highest level of accuracy in basal body temperature measurements. Our device is a flexible ring shaped device that includes a thermocouple, pH sensor, lithium polymer battery, and a silicone coating. The silicone coating ensures patient comfort and biocompatibility during extended periods of time. The design includes a rechargeable battery and is meant to be worn throughout several cycles, including 28 days of continuous use. Several key challenges including sensor calibration and biocompatibility are addressed in this design. Potential applications for this device extend beyond fertility and cycle tracking. Additional applications include detection of bacterial vaginosis, yeast infections, and pregnancies. This design aims to improve reproductive healthcare by individualizing monitoring and providing real time data. Future work on this design includes both short and long term wearability studies, miniaturization, manufacturing optimization, clinical validation and verification. This device is being developed in compliance with FDA regulations and follows Class II Medical Device protocols and guidelines.

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