I-Corps: Minimally-Invasive Gastrointestinal Nutrient Delivery Device

University Of Southern California, Los Angeles CA

Investigators

Abstract

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.