I-Corps: Minimally-Invasive Gastrointestinal Nutrient Delivery Device

这个I-Corps项目的更广泛的影响/商业潜力是提供一种新的方法来管理超重，这是我们时代的主要健康危机之一。肥胖现在影响了近40%的美国人口。它是慢性疾病的主要诱因，包括2型糖尿病和冠状动脉疾病。目前的减肥药和减肥器价格昂贵，而且效果一般，而且很容易引起不良反应。减肥手术是最有效的治疗方法之一，只有不到1%的美国医疗合格人口可以使用或接受。该项目开发了一种医疗设备，可以根据需要在门诊环境中放置和移除，而不需要先进的技术技能或设备。最初的商业化努力将针对因体重过重而拒绝手术的术前患者，在这一群体的临床效益证明后，将扩展到其他客户群。该设备有可能被广泛用于减肥的个人有限的治疗减肥选择。I-Corps项目旨在开发一种微创、完全可逆的医疗设备，以模拟高效减肥手术胃旁路手术后的营养输送方式，将营养输送到上肠。不使用手术或药物，而是以一种新颖的方式使用营养来控制食欲。在胃旁路手术后，营养物质在进食后涌入上肠，这向身体发出信号，表明它已经吃饱了，尽管有明显的热量限制。这种反应不同于单纯节食引起的禁食反应。该装置使用改良的细长肠内喂食管，将选定的营养配方引导到小肠中所需的部位。该项目基于临床研究，该研究表明，通过肠内喂食管将单剂量营养物质快速输送到上肠，可以迅速抑制食欲，减少食物摄入量。一种原型装置已经开发出来，并在一项试点临床研究中进行了测试。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 I-Corps project is to provide a new approach to managing excess weight, one of the major health crises of our time. Obesity now affects nearly 40% of the US population. It is the main contributor to chronic disease, including type 2 diabetes and coronary artery disease. Current weight loss medications and devices are expensive and only moderately effective, with significant concern for adverse events. One of the most effective therapies, bariatric surgery, is available to or acceptable to less than 1% of the medically eligible US population. This project develeops a medical device that can be placed and removed as needed in an outpatient setting without the need for advanced technical skills or equipment. The initial commercialization efforts will be with pre-operative patients who are being denied surgery due to excess weight and, after demonstration of clinical benefit in this group, expand to other customer segments. The device has the potential to be widely used for weight loss by individuals with limited therapeutic weight loss options.This I-Corps project is aimed at developing a minimally-invasive, fully-reversible medical device that delivers nutrient to the upper intestine in a manner that simulates nutrient delivery following the highly effective weight-loss surgery, gastric bypass. No surgery or drugs are used, rather the underlying strategy is to use nutrient in a novel manner to control appetite. Following gastric bypass surgery, nutrient floods the upper intestine after eating and this signals to the body that it has been overfed, despite significant caloric restriction. This response is distinct from the fasting response induced by simple dieting. The device uses a modified slim enteral feeding tube to direct a select nutrient formulation to the desired site in the small intestine. This project is based on clinical research that demonstrates that appetite can be rapidly suppressed, and food intake reduced by a single dose of nutrient delivered rapidly to the upper intestine by an enteral feeding tube. A prototype device has been developed and tested in a pilot clinical study.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.