SBIR Phase I: Endoluminal Fixation of a Distraction Enterogenesis Device

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.