Development of a Reusable, Sensor-Enabled Smart Catheter
Abstract
Populations: Individuals living with spinal cord injury often rely on urinary intermittent catheters to urinate, as their injury interrupts the neural connection between the brain and the bladder. This blocks the sensation of bladder fullness as well as the neurological control needed to urinate, a combination of symptoms collectively referred to as neurogenic bladder. Other than individuals with spinal cord injury, people with spina bifida, multiple sclerosis, parkinsonism, and stroke may also exhibit symptoms consistent with neurogenic bladder. Background: As a result of these symptoms, individuals living with neurogenic bladder and spinal cord injury rely on catheters to drain urine from the bladder. The predominant type of catheters used by people with spinal cord injuries are intermittent catheters, which are only inserted into the body for less than 5 minutes at a time every 4 to 6 hours. The intermittent catheters available on the market are universally labeled for single-use; despite this, individuals with spinal cord injury still frequently get complicated urinary tract infections (UTIs). These UTIs are usually more severe than those that impact the general population, and can require strong antibiotics and/or hospitalization to effectively treat. The causes and signs of complicated urinary tract infections in this population are not well understood by the medical community, and there are competing theories as to why these urinary tract infections develop. Objective: This proposed research will investigate if sensors that track clinically relevant data can be integrated into the existing design of a reusable intermittent catheter system, which includes a near field communications-tagged intermittent catheter and a reprocessing unit that cleans and disinfects the catheter between uses. This system has been developed and patented by CathBuddy, Inc. to improve access to high quality catheters at a lower price point made possible through the safe and standardized reuse of intermittent catheters. CathBuddy, Inc. will collaborate with the Poliks Lab at the Center for Advanced Microelectronics Manufacturing (CAMM), a New York State Center of Advanced Technology for Flexible Medical Device Manufacturing and the New York Node NextFlex Manufacturing USA, at Binghamton University to complete this research. It will involve the development of smart catheter designs that integrate single sensors as well as multi-sensor arrays into the tip, shaft, and funnel of CathBuddy, Inc.’s reusable intermittent catheter. These designs will be prototyped at the CAMM, manufactured by design and fabrication contractors, and tested in purpose-built physical model systems to validate the performance, precision, and reliability of these sensors, even after multiple uses and cleaning/disinfection cycles. Clinical Applications: This research will yield a technology that, through the longitudinal data-tracking made possible with sensor-enabled catheters, can help clinicians improve the understanding of complicated urinary tract infections in an intermittent catheterization setting. We expect that this will help to improve diagnostic decision-making, reduce unnecessary antibiotic use, and reduce healthcare expenses. In the short term, the technology will be utilized by researchers studying bladder physiology of people with spinal cord injuries and will enable the consistent capture of relevant data. This will build a nuanced understanding of urinary health in people with spinal cord injury that may inform personalized prevention and treatment of urinary tract infection as well as the development of novel drugs, therapies, and devices for people living with spinal cord injuries. Time to Person-Related Outcomes: This technology will be integrated into the CathBuddy, Inc. commercially available smart reusable intermittent catheters within the next 5 to 7 years. We expect it will have a tremendous impact on urinary care mana
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210605
Entities
People
- Daniel Wollin
Organizations
- Binghamton University
- United States Army