A Novel Catheter Enterogenesis Device to Treat Short Bowel Syndrome

Mc3, Inc., Ann Arbor MI

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): Abstract Short bowel syndrome (SBS) represents a loss of sufficient length of intestine 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 dollars (corrected to 2005 U.S. dollars). Recently, we have pioneered the application of longitudinal distractive forces, as directed with an intraluminally placed device, to induce intestinal growth - enterogenesis. We have demonstrated significant lengthening of pig small intestine (2.7-fold) over a 10-day period. The lengthening is not merely a stretching of the intestine, but true growth with preservation of intestinal function. The overall goal of this research proposal is to develop a catheter based device which could be placed for days to weeks in a clinical setting to deliver linear forces to the intestine, allowing for an elongation of the intestine while keeping the continuity of the intestine intact. The catheter enterogenesis device (CED) is envisioned as a simple, effective means of improving survival for SBS sufferers. Aims are to define the requirements of the CED in terms of small bowel geometry and tissue properties, to design and build a disposable prototype and to demonstrate safe intraluminal placement, anchoring to the small bowel wall, delivery of distractive forces and acceptable flow of enteric material past the CED. This will pave the way to more extensive Phase 2 studies investigating chronic device application, optimizing the treatment protocol, demonstrating statistically significant bowel lengthening and evaluating possible complications. PUBLIC HEALTH RELEVANCE: Project Narrative The overall goal of this research proposal is to develop a catheter based device which will deliver linear forces to the intestine, allowing for an elongation of the intestine while keeping the continuity of the intestine intact. The catheter enterogenesis device (CED) is envisioned as a simple, effective means of improving survival for short bowel syndrome sufferers.