SBIR Phase I: Endoluminal Fixation of a Distraction Enterogenesis Device

这个小企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力是创建一种用于治疗短肠综合征（SBS）的新型肠延长系统。SBS是一种破坏性疾病，其定义为由于先天性或后天性缺陷导致患者小肠损失超过50%，通常需要手术治疗。对于儿科患者，SBS可能更具破坏性，死亡率接近50%。现有的非手术治疗选择是不够的，往往会导致并发症，如危及生命的中心静脉线感染，凝血的主要静脉系统，代谢失衡，肝脏疾病和器官衰竭。每名SBS患者的平均成本仅营养就在15万至20万美元之间，如果与药物治疗相结合，每年的成本可能超过50万美元。今天，没有已知的SBS恢复性解决方案。该项目将开发一种技术，可以通过内窥镜输送到小肠，而不需要开放手术。该小型企业创新研究（SBIR）第1阶段项目旨在为器械创建第一种固定方法，该器械将通过内窥镜放置在小肠内，暂时固定在适当位置，然后释放，以便在粪便中自然排出体外。目前的固定方法和技术是永久性的，需要开放式外科手术或保持原位的器械。 该项目将按以下方式完成：（1）选择首选固定方法，包括在实验室工作台上制造和测试固定器，以优化固定性能和后续释放;（2）将最佳固定和释放概念与现有内窥镜成像和输送器械结合，以证明系统在实验室工作台上的可行性;和（3）准备一个动物试验系统。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/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.