SBIR Phase I: Endoluminal Fixation of a Distraction Enterogenesis Device

SBIR 第一阶段：牵引肠发生装置的腔内固定

• 批准号: 2036538
• 负责人: Andre Bessette
• 金额: $ 25.6万
• 依托单位: ECLIPSE ENTEROGENESIS, 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: 2020-12-15 至 2022-03-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2036538&HistoricalAwards=false
• 关键词: SBIR; Phase; Endoluminal; Fixation; Distraction

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to create a novel intestinal lengthening system for the treatment of Short Bowel Syndrome (SBS). SBS is a devastating condition defined by the loss of greater than 50% of a patient’s small bowel due to a congenital or acquired defect that often requires surgical treatment. For pediatric patients, SBS can be more devastating with the mortality rate approaching 50%. Existing non-surgical treatment options are inadequate and often lead to complications such as life-threatening central venous line infections, clotting of the major venous systems, metabolic imbalance, liver disease, and organ failure. The average cost per SBS patient ranges from $150,000-$200,000 for nutrition alone, and when combined with pharmaceutical therapies, the cost can exceed $500,000 per year. Today, there is no known restorative solution to SBS. This project will develop a technology that can be delivered endoscopically to the small intestine without the need of open surgery. This Small Business Innovation Research (SBIR) Phase 1 project intends to create the first fixation method for devices to be endoscopically placed inside the small intestine, held temporarily in place, and then released for natural passing out of the body in the stool. Current fixation methods and technology are permanent and require either an open surgical procedure or a device that remains in place. This project will be accomplished as follows: (1) select a preferred fixation method, including fabrication and testing subassemblies on the laboratory bench to optimize fixation performance and subsequent release; (2) incorporate the optimal fixation and release concept with existing endoscopic imaging and delivery devices to demonstrate system feasibility on the laboratory bench; and (3) prepare a system for animal testing.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.

这项小企业创新研究（SBIR）一期项目的更广泛影响/商业潜力是创造一种用于治疗短肠综合征（SBS）的新型肠道延长系统。SBS是一种毁灭性的疾病，由于先天性或获得性缺陷，患者小肠损失超过50%，通常需要手术治疗。对于儿科患者来说，SBS的死亡率可能更大，接近50%。现有的非手术治疗方案不足，并经常导致并发症，如危及生命的中心静脉线感染、主要静脉系统凝血、代谢失衡、肝脏疾病和器官衰竭。每名SBS患者仅营养方面的平均费用就在15万至20万美元之间，如果与药物治疗相结合，每年的费用可能超过50万美元。目前，还没有已知的恢复SBS的解决方案。这个项目将开发一种技术，可以通过内窥镜进入小肠，而不需要开腹手术。这项小型企业创新研究（SBIR）第一阶段项目旨在创造第一种固定方法，通过内窥镜将设备放置在小肠内，暂时固定在原位，然后释放，使其随粪便自然排出体外。目前的固定方法和技术是永久性的，需要开放的外科手术或保留在原位的装置。本项目将完成如下工作：(1)选择一种首选的固定方法，包括在实验室工作台上制作和测试组件，以优化固定性能和随后的释放；(2)将最佳固定和释放概念与现有的内窥镜成像和输送设备结合起来，在实验室台上演示系统的可行性；(3)准备动物试验系统。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。