Non Invasive Urine Output Monitor

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.

Grant Number: 1R41EB036929-01A1
NIH Institute/Center: NIH
Principal Investigator: Katherine Brown