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

SBIR 第一阶段：开发基于灭菌的可重复使用导尿系统

• 批准号: 2021595
• 负责人: Souvik Paul
• 金额: $ 25.6万
• 依托单位: CATHBUDDY, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2021-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2021595&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; Sterilization; based

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.

这项小型企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力将是改善间歇性尿导管插入的过程，同时减少因解剖学或生理原因而无法空膀胱的个体相关感染的风险，由于单一使用的间歇性导管是一种使膀胱空的空白的方法。尽管如此，典型的导管方法每年产生40-60％的尿路感染风险，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。某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，但是这些工具更为昂贵且很少使用。为了解决这一成本，一些人试图对单利用导管进行消毒，并以标签外的方式重复使用，将尿路感染的风险增加到每年70-80％。该项目旨在开发具有无接触导管的好处的安全可重复使用的导管，从而允许在家进行灭菌设备。这种创新将使尿路感染风险降低，导管可用性的提高，导管支出的降低以及与导管相关的废物的减少99％。这项小型企业创新研究（SBIR）I阶段项目将重点关注这种新型专用构建的导管型生物的技术灭菌能力，尤其是在处理预期的BAC形式时。这项研究将涉及将导管样品暴露于病原体接种的尿液中，进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记录幸存细菌和生物膜形成的存在和位置。预计这种新型设备固有的预期灭菌技术将为安全导管重用提供足够的灭菌保证。该项目还将重点关注实验室验证清洁和灭菌协议的可行性，以供预期的用户在没有医疗监督的情况下执行。这项研究将检查单个导管用户的清洁和灭菌协议，以确定为设备设计和协议的潜在风险点。该奖项反映了NSF的法定任务，并被认为是值得通过基金会的知识分子和更广泛影响的评估审查标准来通过评估来支持的。