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

这项小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力将是改善间歇性导尿术的过程，同时降低相关感染的风险。对于因解剖或生理原因无法排空膀胱的个人，一次性间歇性导尿术是膀胱排空的最安全方法。尽管如此，典型的导尿方法每年产生40-60%的复杂性尿路感染风险，导致超过40亿美元的可避免的医疗保健费用和患者发病率。一些导管插入工具比标准的一次性导管（例如无接触导管）更安全，但这些工具更昂贵且很少使用。为了解决这一成本问题，一些人试图对一次性使用的导尿管进行消毒，并以标签外的方式重复使用，这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，具有无接触导管的优点，可用于家庭灭菌装置;这种创新将允许降低尿路感染的风险，改善导管的可用性，减少导管的花费，并减少99%的导管相关废物。这项小型企业创新研究（SBIR）第一阶段项目将重点关注这种新型专用导管灭菌装置的技术灭菌能力，特别是在处理预期形成的细菌生物膜时。这项研究将涉及将导管样本暴露于病原体接种的尿液，执行预期的清洁和灭菌方法，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。预期该新型器械固有的预期灭菌技术将为安全重复使用导管提供充分的灭菌保证。该项目还将重点关注实验室确认的清洁和灭菌方案的可行性，以便预期用户在没有医疗监督的情况下进行操作。这项研究将检查清洁和消毒方案的个人导管用户，以确定潜在的风险点，通知设计的设备和protocol.This奖项反映了NSF的法定使命，并已被认为是值得的支持，通过评估使用基金会的知识价值和更广泛的影响审查标准。

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.