SBIR Phase I: A Novel Device Alternative to Temporary Ostomies

该小型企业创新研究（SBIR）第一阶段项目的更广泛影响是通过减少或消除临时造口的需要来改善结肠癌患者的护理和生活质量，为每位患者节省25 + k美元的直接手术费用，并为每位患者节省8.5 k美元的年度维护费用;这可以为每位治疗患者节省6万美元的总费用。所提出的解决方案可以解决临时造口手术的需求;在美国，这种手术每年进行300，000多次。 该系统将降低结肠切除术后肠漏的风险，大约36%的患者会出现这个问题，22%的患者会产生致命的后果。更重要的是，该技术有可能大大减少或消除造口的发病率和死亡率，并提高患者的生活质量。 研究和开发一种可靠的、可逆的和具有成本效益的方法来保护肠段具有更广泛的意义和潜在的应用，以治疗许多疾病，如克罗恩病、溃疡性结肠炎、憩室炎、缺血性肠病、肠创伤，甚至早期结肠癌。拟议的项目将开发一种系统，以减少改道造口，其通常放置在重新连接位置的上方以防止泄漏及其后果。该项目将开发一种使用安全、可靠且易于逆转的新型锚定机制的腔内粪便分流技术。 该项目的目标是优化设备和临床治疗算法的设计、安全性和使用;并在随后的动物研究中验证新的设计和方案。该奖项反映了NSF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 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.