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

SBIR 第二阶段：可重复使用的非接触式导管系统的开发和设计验证

• 批准号: 2147852
• 负责人: Souvik Paul
• 金额: $ 100万
• 依托单位: CATHBUDDY, INC.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2147852&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Development; Design

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.

这项小型企业创新研究（SBIR）II期项目的更广泛的影响/商业潜力将是将新颖，可重复使用的，间歇性的尿导管系统从功能性原型到最终生产等效设备。通过通过其他设计改进和FDA提交来进步系统，该项目的目的是使产品能够接触到需要间歇性导管小便的个人的手。当前的间歇性尿导管的使用充满并发症，包括频繁的尿路感染，昂贵的供应和大型材料足迹，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管系统的商业化来改善当前导管景观，该导管系统将在插入过程中减少接触污染，减少塑料废物，并通过降低每用途成本来广泛使用高质量的尿管。通过这些改进，与间歇性导管插入术有关的医疗保健成本可以大大降低。此外，基于与敏捷不良的个人进行频繁互动，系统的设计将结合当前导管插入空间内经常被忽视的人的需求和思想。这II阶段项目将最终确定一个小说，可延期，间歇性的导管系统和端口的设备，并将其用于良好的设备，并将其置于端口化的设备，并将其用于端口化的设备。自1970年代以来，间歇性尿管插入术是一个技术上静态的领域，尿路感染风险，供应成本和降低环境废物的变化最小。尽管相关的SBIR I期项目建立了概念验证导管后处理，但II期项目将包括优化和更先进的微生物学疗效测试。该评估将集中于专门解决有关SBIR I阶段客户发现活动中提出的润滑和紧凑性的问题，以及多次重复使用后处理。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优点和更广泛影响的审查标准来通过评估来通过评估来支持的。