Short bowel syndrome (SBS) results in significant morbidity and mortality in children and adults. It is a chronic condition that occurs in up to 25 i 100,000 live births, affects at least 15,000 adults, and costs more than $2.3 billion annually in the United States. SBS is caused by loss of intestinal length, and thus digestive and absorptive capacity as a result of various surgical diseases. For patients who do not have enough bowel to absorb appropriate calories, the only therapies are long term parenteral nutrition, with its dual risks of catheter related blood stream infections and liver failure, or intestinal transplantation, which carries risks related to rejection and immunosuppression. One alternative is to mechanically stretch the small segments of bowel to induce growth. This has been used widely in other types of tissue. We propose a new extraluminal model of distraction enterogenesis (growth of small bowel by stretch) that uses shape memory polymer (SMP) device. This material can be shaped to custom specifications and works as a self-deploying tissue expander, which can provide exact forces to stretch the bowel in an appropriate pattern to promote effective growth safely. This grant will sponsor phase I research allowing for SMP device development and initial animal in vivo studies. This research will be conducted through two aims. First, SMPs will be synthesized, tested and their performance will be evaluated. Second, prototype devices will be implanted in vivo and the resulting intestinal growth and function will be characterized.
We aim to create an implantable device and animal model that effectively and safely induces bowel growth that will be scalable to larger animals and humans. This research will be carried out by scientists at MedShape and surgeons at Boston's Children's Hospital.

Public Health Relevance

Short bowel syndrome is a chronic condition that occurs in up to 25 in 100,000 live births, affects at least 15,000 adults, and costs more than $2.3 billion annually in the United States. Most of the morbidity, mortality (up to 50%), and cost stem from the chronic use of parenteral nutrition. Distraction enterogenesis is a potential therapy to augment patients' bowel function by promoting growth of intestine, which would ultimately allow them to wean from parenteral nutrition. This proposal seeks to employ shape memory polymer technology to effectively and safely induce intestinal growth.

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 I (R43)
Project #
1R43DK105735-01
Application #
8905061
Study Section
Special Emphasis Panel (ZRG1-DKUS-N (10))
Program Officer
Densmore, Christine L
Project Start
2015-04-01
Project End
2015-09-30
Budget Start
2015-04-01
Budget End
2015-09-30
Support Year
1
Fiscal Year
2015
Total Cost
$149,457
Indirect Cost
Name
Medshape Solutions, Inc.
Department
Type
DUNS #
601306413
City
Atlanta
State
GA
Country
United States
Zip Code
30318