SBIR Phase I: Development of a Sterilization-based Reusable Catheterization System

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be to improve the process of intermittent urinary catheterization while decreasing the risk of associated infection For individuals who cannot empty their bladder due to anatomic or physiologic causes, single-use intermittent catheterization is the safest method for bladder emptying. Despite this, typical catheterization methods produce an annual 40-60% risk of complicated urinary tract infection, leading to over $4 billion of avoidable healthcare costs and patient morbidity. Some catheterization tools are safer than standard disposable catheters (e.g. no-touch catheters), but these are more costly and rarely used. To address this cost, some individuals attempt to sterilize their single-use catheters and reuse them in an off-label manner, increasing the risk of urinary tract infection to 70-80% per year. This project aims to develop a safe reusable catheter with the benefits of a no-touch catheter, allowing for an at-home sterilization device; this innovation will allow for a decrease in urinary tract infection risk, improvement in catheter usability, decreased catheter spending, and a 99% reduction of catheter-associated waste.This Small Business Innovation Research (SBIR) Phase I project will focus on the technical sterilization abilities of this novel purpose-built catheter sterilization device, especially when dealing with anticipated formation of bacterial biofilms. This research will involve exposing catheter samples to pathogen-inoculated urine, performing the anticipated cleaning and sterilization methodologies, and utilizing previously-validated fluorescence imaging techniques to document the presence and location of surviving bacteria and biofilm formation. It is expected that the intended sterilization techniques inherent in this novel device will provide adequate sterilization assurance for safe catheter reuse. This project will also focus on the feasibility of the laboratory-validated cleaning and sterilization protocol for anticipated users to perform without medical supervision. This research will examine cleaning and sterilization protocols by individual catheter users to determine points of potential risk to inform design of the device and the protocol.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.