A Novel Catheter Enterogenesis Device to Treat Short Bowel Syndrome

Period of Performance: 07/01/2012 - 06/30/2013

$456K

Phase 2 SBIR

Recipient Firm

Mc3, Inc.
DEXTER, MI 48130
Principal Investigator
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): Short bowel syndrome (SBS) represents a large loss of intestinal length, compromising the absorption of nutrients and fluids to sustain life. Although patients may be maintained on parenteral (intravenous) nutrition, the morbidity can be devastating and associated mortality rates exceed 30%. Care for each SBS patient is in excess of $250,000 per year and estimated costs for just the first five years of the care of a child with SBS exceed 1.5 million. Although a number of strategies have been used to treat SBS, the results have been disappointing with high complication rates and death. Application of longitudinal distractive forces, as directed with an intraluminally placed device, induces intestinal growth in pig small intestine (1.7-fold) over a 7-day period. The lengthening (enterogenesis) is not merely a stretching of the intestine, but true growth with preservation of intestinal function. The goal of this proposal is to develop a catheter-based device which could be placed intralumenally for days to weeks in a clinical setting to deliver longitudinal forces to the intestine, allowing for an elongation of the bowel while keeping the continuity of the gastrointestinal tract intact. The catheter enterogenesis device (CED) is envisioned as a simple, effective means of improving survival for SBS sufferers. Phase 1 resulted in the successful development of a working prototype. Two inflated balloons effectively anchored to the intestinal wall and delivered the forces previously determined to be effective for enterogenesis. The aims of this proposal is to develop the insertion and removal technique for the device with a preference for endoscopic placement, to assess the safety of the device through blood flow measurements, gross tissue examination and histological assessment and finally to demonstrate the efficacy of the device to lengthen the bowel in a chronic study. Device development will accompany each stage. The overall impact of this device will provide a low cost, safe and effective device to treat patients with short bowel syndrome in response to a tremendous unmet need for patients and their families. Variations of the CED may treat disease processes in other hollow visceral organs such as esophageal and intestinal atresia, ischemic and infection processes resulting in massive colon resection and congenital exstrophy.