SBIR Phase II: Endoluminal Fixation of a Distraction Enterogenesis Device

这项小企业创新研究（SBIR）二期项目的更广泛影响/商业潜力是推进一种治疗短肠综合征的创新疗法。与目前慢性且与危险并发症、再住院和高死亡率相关的非根治性治疗相比，拟议的解决方案有可能大大改善患者及其家属的预后和生活质量。这个项目潜在的商业影响同样巨大。目前，治疗短肠综合征的费用为每位患者每年数十万美元。使美国每年的医疗支出增加了50多亿美元。因此，提出的治疗方案可以节省大量的金钱和专家的时间。这个小企业创新研究（SBIR）二期项目将为短肠综合征患者创造一种治疗方法，目前该患者通过静脉营养治疗，缺乏有效的治疗方法。提出的解决方案将延长肠道，增加吸收表面积，恢复肠道的自然功能，使患者能够从他们所吃的食物中获得足够的营养。所提出的系统包括非破坏性组织锚和一个推动它们拉伸肠道并迫使其生长的弹簧。在开发组织锚定之前，该项目开发了一种递送方法，使系统能够通过微创手术植入肠道。将从儿科胃肠病学家和外科医生那里收集有关交付方法的反馈，并且将在临床前大型动物研究中测量设备的性能。拟议项目的成功完成将证明通过微创手术实现体内肠道延长，并为规划后续临床前测试奠定基础，这将是监管部门批准该产品商业化所必需的。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/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the advancement of an innovative therapy for Short Bowel Syndrome. Compared to current non-curative treatments that are chronic and associated with dangerous complications, rehospitalization, and high mortality, the proposed solution has the potential to substantially improve outcomes and quality-of-life for patients and their families. The potential commercial impact of this project is likewise substantial. Treating short bowel syndrome currently costs hundreds of thousands of dollars per patient per year. adds more than $5 billion to US healthcare expenditures annually. Thus, the proposed curative solution can lead to enormous savings in dollars and in specialists’ time.This Small Business Innovation Research (SBIR) Phase II project will create a curative therapy for patients with Short Bowel Syndrome, which is currently managed with intravenous nutrition and lacks effective treatments. The proposed solution will lengthen the intestine, increasing the absorptive surface area and restoring the natural function of the gut, enabling patients to get sufficient nutrition from the food they eat. The proposed system comprises nondestructive tissue anchors and a spring that pushes against them to stretch the intestine and force it to grow. Having previously developed the tissue anchors, this project develops a delivery method that will allow the system to be implanted in the intestine through a minimally invasive procedure. Feedback will be gathered from pediatric gastroenterologists and surgeons about the delivery method, and device performance will be measured in pre-clinical large-animal studies. Successful completion of the proposed project will demonstrate intestinal lengthening in vivo, achieved via a minimally invasive procedure, and establish a foundation for planning subsequent preclinical testing that will be required for regulatory approval to commercialize the product.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.