SBIR Phase II: Development and Design Verification of a Reusable, No-Touch Catheter System

这个小企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力将是将一种新颖的、可重复使用的、间歇性的导尿系统从一个功能原型推进到最终的生产等效设备。通过进一步的设计改进和FDA的提交，这个项目的目标是使产品能够到达需要间歇导尿的人的手中。目前间歇性导尿管的使用充满了并发症，包括频繁的尿路感染，昂贵的供应，大量的材料足迹，以及产生大量的塑料废物。该项目旨在通过允许可重复使用的导尿管系统的商业化来改善当前的导尿管景观，该系统将减少插入过程中的接触污染，减少塑料废物，并通过降低每次使用成本来实现高质量导尿管的广泛使用。通过这些改进，与间歇性导尿相关的医疗成本可以显著降低。此外，基于与导尿患者的频繁互动和灵巧性受损，系统的设计将纳入当前导尿领域创新过程中经常被忽视的人们的需求和想法。这个小企业创新研究（SBIR）二期项目将完成一种新型、可重复使用的间歇导尿系统和便携式后处理设备的设计，并将该系统推向商业化。间歇导尿是一个技术上静态的领域，自20世纪70年代以来没有显著改变，在尿路感染风险、供应成本和减少环境浪费方面几乎没有改善。虽然相关的SBIR一期项目建立了导管再处理的概念验证，但二期项目将包括优化和更先进的微生物功效测试。该评估将特别关注SBIR第一阶段客户发现活动中提出的润滑和紧凑性问题，以及多次重复使用再处理。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值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 II project will be to advance a novel, reusable, intermittent, urinary catheterization system from a functional prototype to the final production-equivalent device. By progressing the system through additional design improvements and FDA submission, the goal of this project is to enable the product to reach the hands of individuals who require intermittent catheters to urinate. Current intermittent urinary catheter use is fraught with complications including frequent urinary tract infections, expensive supplies, and large material footprints, as well as the generation of a significant amount of plastic waste. This project seeks to improve the current catheter landscape by allowing for commercialization of a reusable catheter system that will reduce contact contamination during insertion, reduce plastic waste, and enable widespread use of high-quality urinary catheters by decreasing the per-use cost. Through these improvements, healthcare costs associated with intermittent catheterization can be dramatically decreased. Additionally, based on frequent interactions with individuals who catheterize and suffer from impaired dexterity, the design of the system will incorporate the needs and ideas of people who are often ignored during innovation within the current catheterization space.This Small Business Innovation Research (SBIR) Phase II project will finalize the design of a novel, reusable, intermittent urinary catheterization system and portable reprocessing device as well as advance the system towards commercialization. Intermittent urinary catheterization is a technologically static field that has not changed significantly since the 1970s, with minimal improvements in urinary tract infection risk, supply cost, and environmental waste reduction. While the associated SBIR Phase I project established proof-of-concept catheter reprocessing, the Phase II project will include optimization and more advanced microbiologic efficacy testing. This assessment will focus on specifically addressing concerns regarding lubrication and compactness brought up during SBIR Phase I customer discovery activities, as well as multiple reuse reprocessing.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.