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.

Public Health Relevance

The overall goal of this research proposal is to develop a catheter based device which will deliver linear forces resulting in the growth of the intestine. The catheter enterogenesis device (CED) is envisioned as a simple, minimally invasive and effective means of improving survival for short bowel syndrome sufferers.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44DK085765-03
Application #
8296352
Study Section
Special Emphasis Panel (ZRG1-DKUS-E (10))
Program Officer
Densmore, Christine L
Project Start
2009-12-01
Project End
2014-06-30
Budget Start
2012-07-01
Budget End
2014-06-30
Support Year
3
Fiscal Year
2012
Total Cost
$455,717
Indirect Cost
Name
MC3, Inc.
Department
Type
DUNS #
806687406
City
Ann Arbor
State
MI
Country
United States
Zip Code
48103
Demehri, Farokh R; Wong, Philip M; Freeman, Jennifer J et al. (2014) A novel double-balloon catheter device for fully endoluminal intestinal lengthening. Pediatr Surg Int 30:1223-9
Ralls, Matthew W; Sueyoshi, Ryo; Herman, Richard et al. (2013) Development of a novel approach to safely couple the intestine to a distraction-induced device for intestinal growth: use of reconstructive tissue matrix. Pediatr Surg Int 29:151-6