SBIR Phase II: A Novel Device Alternative to Temporary Ostomies

这项小企业创新研究（SBIR）二期项目的更广泛影响是改善结肠癌患者的护理和生活质量，同时降低医疗保健成本。开发一种可靠的、可逆的、具有成本效益的方法来保护肠段，在治疗许多常见疾病如结肠癌、克罗恩病、溃疡性结肠炎、憩室炎、缺血性肠病和腹部创伤等方面具有潜在的应用前景。在美国，每年有超过12万例临时造口手术，其中大部分可以随着资助技术的发展而消除，解决了64亿美元的总市场机会。这项资助的设备最初将针对4万多名进行低位肠切除术的患者，其中大多数是直肠癌患者。这意味着美国的初始市场规模为2亿美元。仅在美国直肠切除市场全面渗透的整体影响是节省24亿美元。这项小型企业创新研究（SBIR）二期项目推进了一种保护肠道部分的新技术的开发。结直肠癌是第三大最常见的癌症，大约30-40%的病例涉及直肠。直肠癌的典型治疗方法是手术切除。然而，术后吻合口瘘发生率高达10-18%，伴有严重腹部败血症的高死亡率。目前，为了减轻吻合口泄漏的严重后果，通常将转移造口置于吻合口之上，但临时造口本身是高度病态的，具有显著的死亡率风险，对医疗系统来说是昂贵的，并且严重影响患者的生活质量。这项获得资助的技术是一种医疗设备，在愈合过程中为肠道提供暂时的、微创的保护，避免了转移造口的需要。该项目将进行设计验证测试、最终用户测试和大型动物验证测试，以获得人类研究批准。该项目的目标是拥有一个完全验证的（完成台式和动物试验），临床准备的医疗设备，为进一步开发做好准备。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 of this Small Business Innovation Research (SBIR) Phase II project is to improve the care and quality of life of colon cancer patients while reducing healthcare costs. The development of a reliable, reversible, and cost-effective means to protect segments of bowel has potential applications to treating a number of common disease conditions such as colon cancer, Crohn’s disease, ulcerative colitis, diverticulitis, ischemic bowel disease, and abdominal trauma. There are more than 120,000 temporary ostomies (surgical openings) performed each year in the US, and a majority of these can be eliminated with the development of the funded technology, addressing a $6.4 Billion total market opportunity. This funded device will initially target the over 40,000 individuals who have low bowel resections, the majority for rectal cancer. This represents an initial market size of $200 million in US. The overall impact with full market penetration in just the US rectal resection market is $2.4 billion in savings.This Small Business Innovation Research (SBIR) Phase II project advances the development of a novel technology to protect segments of bowel. Colorectal cancer is the third most common cancer with about 30-40% of cases involving the rectum. Rectal cancer is typically treated with surgical resection. However, anastomotic leaks can occur in up 10-18% of patients after resection, with an associated high mortality due to severe abdominal sepsis. Currently, diverting ostomies are typically placed above the anastomosis to mitigate the severe consequences of an anastomotic leak, but temporary ostomies themselves are highly morbid, have significant risk of mortality, are expensive to the healthcare system, and drastically impact patient’s quality of life. The funded technology is a medical device that provides temporary, minimally invasive protection of bowel during the healing process, avoiding the need for a diverting ostomy. This project will perform design verification testing, end user testing, and large animal validation testing required for human study approval. The goal of this project is to have a fully validated (both benchtop and animal testing completed), clinically ready medical device ready for further development.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.