SBIR Phase I: A Novel Device Alternative to Temporary Ostomies

SBIR 第一阶段：替代临时造口的新型设备

• 批准号: 1938482
• 负责人: Kenton Fong
• 金额: $ 22.5万
• 依托单位: Savage Medical 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: 2020-03-01 至 2021-02-28
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1938482&HistoricalAwards=false
• 关键词: SBIR; Phase; Novel; Device; Alternative

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to improve the care and quality of life of colon cancer patients by reducing or eliminating the need for temporary ostomies, saving $25+ k per patient in direct surgical costs and eliminating $8.5 k per patient in annual maintenance costs; this could generate total savings of $60 k per patient treated. The proposed solution could address the need for temporary ostomy surgery; this procedure is performed 300,000+ times per year in the US. This system would reduce the risks of bowel leakage after colon resections, a problem occurring in roughly 36% of patients and generating fatal consequences in 22%. More importantly, the technology has the potential to dramatically reduce or eliminate the morbidity and mortality from ostomies and improve a patient’s quality of life. The research and development of a reliable, reversible, and cost-effective means to protect segments of bowel has broader implications and potential applications to treating a number of disease conditions, such as Crohn’s disease, ulcerative colitis, diverticulitis, ischemic bowel disease, bowel trauma, and even early colon cancer.The proposed project will develop a system to reduce diverting ostomies, which are often placed above the reconnection site to protect against leaks and their consequences. This project will develop an intraluminal fecal diversion technology using a novel anchoring mechanism that is safe, reliable, and easily reversible. The goal of this project is to optimize the design of both the device and clinical treatment algorithms for design, safety, and use; and validate the new design and protocols in subsequent animal studies.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阶段项目的更广泛影响是通过减少或消除对临时性术语的需求，为直接手术成本节省25+ K的需求，从而改善结肠癌患者的护理和质量，并消除每位患者每位患者每年维护成本的$ 8.5 K；这可能会产生每位接受治疗的患者$ 60 K的总节省。提出的解决方案可以解决暂时造口术手术的需求。在美国，此过程每年执行300,000次以上。该系统将减少结肠切除后肠泄漏的风险，大约36％的患者发生问题，并产生22％的致命后果。更重要的是，该技术有可能大大降低或消除术语的发病率和死亡率并改善患者的生活质量。一种可靠，可逆和成本效益的方法的研究和发展保护肠细分具有更广泛的影响和潜在的治疗，以治疗许多疾病，例如克罗恩病，溃疡性结肠炎，溃疡性结肠炎，缺血性肠道疾病，诊断，肠外伤，肠外伤，甚至是早期的colon colon consection systems of System systemies to neproys to s eusipome syport of sivers ost ost ost ost s的漏洞他们的后果。该项目将使用一种安全，可靠且易于可逆的新型锚定机制开发出腔内粪便转移技术。该项目的目的是优化设计，安全性和使用的设备和临床处理算法的设计；并在随后的动物研究中验证了新的设计和协议。该奖项反映了NSF的法定任务，并通过使用基金会的知识分子优点和更广泛的影响标准来评估，被认为是宝贵的支持。