Research Project
9136437
? DESCRIPTION (provided by applicant): Enteral nutrition using feeding tubes provides a long-term means of improving the nutritional status for infants and children with neurological syndromes, cancer, gastrointestinal disease, cardiac disease, and metabolic disease by allowing administration of feeding formula directly to the stomach through the upper abdomen. More than 70,000 pediatric percutaneous gastrostomy (PG) tubes are placed in US hospitals annually. The majority of PG tube complications-resulting in 15% morbidity-include microbial contamination, tube clogging, dislodgement, and stomal complications. Prevention of PG tube complications requires implementation of innovative biomaterials that are safe for vulnerable infant and child populations. This directive is consistent with the NIH goals of improving human health, as well as the specific NICHD goals of ensuring that all children have the chance to achieve their full potential for healthy and productive lives, free from disease and disability. In pursuit of those important goals, Sharklet Technologies Inc. proposes to incorporate a bio-inspired Sharklet micropattern on pediatric PG tubes to significantly reduce bacterial contamination, clogging, displacement, and stomal complications. The anticipated impact of this technology is to reduce PG device failure, thereby generally improving infant and child health for thousands and minimizing pediatric patient morbidity. The Sharklet micropattern achieves these effects without the use of chemical additives or toxic compounds, which is important for a pediatric population that is typically more sensitive to medical device surface chemicals. The power of Sharklet is that the novel micropattern can be produced in the same approved biomedical materials used currently. The improved PG device envisioned by the Sharklet R&D team is expected to 1) reduce bacterial contamination that causes infections, 2) improve feeding formula flow to reduce clogging, and 3) enhance stoma formation to limit dislodgement and painful stoma site cellulitis. The feasibility of attaining each of these improvements will be pursued by the expert Sharklet interdisciplinary team via two main Phase I SBIR Specific Aims {involving testing device prototypes with the Sharklet micropattern}. Aim 1 will focus on {implementing} the Sharklet micropattern to the PG tube lumen to reduce feeding formula accumulation by at least 50% (p<0.05) and microbial biofilm formation by >90% (p<0.05). Aim 2 will focus on {implementing} the Sharklet micropattern to the device exterior to promote at least 50% (p<0.05) faster in vitro epidermal keratinocyte migration and >25% (p<0.05) thicker stomal wall formation in vivo. Key preliminary work by Sharklet is a strong foundation for achieving these Aims. Once Phase I SBIR milestones are met, a follow-on Phase II SBIR project will be focused on completing development/commercialization of the Sharklet micropatterned PG device. Sharklet Technologies has extensive experience in developing and commercializing medical devices: previous incorporation of the Sharklet micropattern for {alternative mechanisms of preventing device complications} have been accomplished on a Foley urinary catheter and an endotracheal tube.
