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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力将是改进间歇性导尿的过程，同时降低因解剖或生理原因而无法排空膀胱的个人的相关感染风险，一次性间歇性导尿是最安全的膀胱排空方法。尽管如此，典型的导尿方法每年产生40%-60%的复杂尿路感染风险，导致超过40亿美元的可避免的医疗成本和患者发病率。一些导尿工具比标准的一次性导尿管更安全(例如非接触式导尿管)，但这些工具更昂贵，很少使用。为了解决这一成本，一些人试图对他们的一次性使用导尿管进行消毒，并以标签外的方式重复使用它们，从而将尿路感染的风险增加到每年70%-80%。该项目旨在开发一种安全的可重复使用的导管，具有非接触式导管的优点，允许在家中使用灭菌装置；这一创新将降低尿路感染风险，提高导管的可用性，减少导管相关的浪费，并减少99%的导管相关废物。这个小型企业创新研究(SBIR)第一阶段项目将专注于这种新型专用导管灭菌装置的技术灭菌能力，特别是在处理预期的细菌生物被膜形成时。这项研究将涉及将导管样本暴露于接种病原体的尿液中，执行预期的清洁和消毒方法，并利用先前验证的荧光成像技术来记录存活细菌和生物膜形成的存在和位置。预计这种新型装置所固有的预定灭菌技术将为安全的导管重复使用提供足够的灭菌保证。该项目还将侧重于实验室验证的清洁和消毒方案的可行性，以供预期用户在没有医疗监督的情况下执行。这项研究将检查每个导管使用者的清洁和灭菌方案，以确定潜在的风险点，以便为装置和方案的设计提供信息。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.