Non Invasive Urine Output Monitor

Thormed Innovation Llc, Dallas TX

Investigators

Abstract

PROJECT SUMMARY ThorMed Innovation aims to develop a reusable and noninvasive wearable product that reduces the use of the current gold standard of indwelling urethral catheterizations for the purpose of monitoring organ function. The goal is to produce an automated measurement platform that achieves the high accuracy required for hemodynamic monitoring and would transform the management of patients undergoing surgical procedures and in intensive care settings. Indwelling urethral catheterization is the leading cause of secondary nosocomial bloodstream infections with an associated mortality rate of 10% and a financial impact of $1.82 billion annually in the United States. While the CDC has issued guidance to reduce the use of IUCs, there is no alternative method of monitoring that meets the need. Cart-based ultrasound (US) and portable Point-Of- Care Ultrasound (POCUS) units provide accurate volume measurements, but their use is impractical due to the need for a sonographer, specialized, and often large equipment. A novel solution is a Wearable Wireless Ultrasound (US) urinary Bladder Monitoring system (WWUS-BM). The technical challenges of creating such a device include integrating low power electronics to achieve a wearable form-factor with long battery life, capable of automated measurements of very high accuracy. The specific aims of this proposal are to: (1) Develop a wearable ultrasound platform with integrated electronic and mechanical platform providing 3D imaging and wireless connectivity to a smart device. (2) Develop and validate custom volume measurement software to delineate the outline of the bladder and compute an accurate 3D volume from multiple 2D acquired scans. (3) Validate accuracy of WWUS-BM with in vitro experiments and ex vivo in pig bladder. The outcome of this program will be a wearable unit for autonomous hemodynamic monitoring that can move to a clinical trial in Phase 2.