MEDSHAPE, INC. — Department of Health and Human Services SBIR Phase I: 300

Description

DESCRIPTION provided by applicant Short bowel syndrome SBS results in significant morbidity and mortality in children and adults It is a chronic condition that occurs in up to i live births affects at least adults and costs more than $ 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 Bostonandapos s Childrenandapos s Hospital PUBLIC HEALTH RELEVANCE Short bowel syndrome is a chronic condition that occurs in up to in live births affects at least adults and costs more than $ billion annually in the United States Most of the morbidity mortality up to and cost stem from the chronic use of parenteral nutrition Distraction enterogenesis is a potential therapy to augment patientsandapos 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