Background: Continuous bladder irrigation (CBI) is a common post-operative treatment option for the management of gross hematuria in pediatric patients. Current treatment systems have several limitations such as the lack of standardized assessment of hematuria severity as well as the need for manual adjustments leading to a significant work effort requirement by the bedside clinical staff and the risk of complications if inadequate oversight is administered. The goal was to develop a novel adaptive, automated, and intuitive CBI system that avoids the need for frequent manual monitoring as well as provides a standardized assessment of hematuria severity.
Methods:An engineering and clinical team jointly produced a novel CBI device for pediatric patients by developing design specifications and system diagrams for the device as well as identifying five key design components. Considerations for clinical accuracy, cost, technical complexity, reliability, form factor, ease of automation, and responsivity were prioritized.
Results:A high-fidelity, fully functioning device prototype was developed that addressed the five key designs components and were integrated via a software system that consolidated all sensor data and user inputs while displaying the clinical information on a user-friendly interface that included remote access. 1) Hematuria severity measurement – benchtop testing revealed an accuracy of greater than 95% with a spectral sensor that calculated the blood concentration in the outflow waste fluid based on the color intensity at 6 visible wavelength channels with a nonlinear least-squares regression analysis. 2) Inflow rate control – a tube compression apparatus utilized a linear actuator to compress the CBI tubing and control the saline inflow rate with submillimeter precision with an error rate of less than 3%. 3) Supply/waste bag volume and inflow/outflow rate measurement – Weight-based sensors were able to measure the supply and waste bag volumes and the inflow and outflow rates based on weight change over time with an error rate of less than 3%. 4) User Interface - A web-based, interactive, bedside touchscreen display that consolidated all sensor and patient data in a user-friendly format was created that included remote access capabilities. 5) Notification System: the interface incorporated LED lights, speakers, and SMS text alerts to deliver notifications regarding system issues such as abnormal flow rates, increased severe hematuria, and the need for saline/waste bag replacement.
Conclusions:A novel automated and intuitive UTI and blood clot prevention device for continuous bladder irrigation in pediatric patients with gross hematuria can provide standardized quantitative hematuria measurements and an automated saline flow control to individualize CBI to specific patient needs via a user-friendly interface. Future studies will assess the patient and provider usability of this device in clinical settings.
