Project Description:

The Pouch Pal revolutionizes neonatal ostomy care by introducing an independent three-ringed device designed to improve the refeeding process. An ostomy is when the patient has a segment of their intestine cut, and each end is sutured to the belly’s surface. Currently, neonates with ostomies face challenges when refed through ostomy bags, including catheter dislodgement, stool leakage, and time-intensive setup. This novel solution addresses this urgent clinical need and focuses on enabling healthcare providers to easily refeed patients, ensuring efficacy and efficiency.

With approximately 375,000 neonates requiring ostomies annually in the US, the market demand for improved ostomy care is significant. As part of the care, refeeding allows for continuing the development of the intestine, which is crucial for recovery. This process involves collecting stool drainage from the proximal opening of the intestine, known as the stoma, and then injecting it through a catheter into the distal segment of the bowel, known as the mucous fistula. The current standard of care requires custom modification of the collection bag to allow catheter entry. The Pouch Pal aims to address this inefficiency by integrating a catheter port, which will facilitate the refeeding process and improve patient outcomes. Extensive evaluation, including catheter diameter testing, leak testing, and membrane tensile testing, has verified the efficacy of the Pouch Pal design.

The Pouch Pal seamlessly integrates with any standard ostomy bag. The silicone membrane ensures a leakproof seal around the catheter, decreasing the risk of catheter dislodgement and peripheral line infections. The magnetic attachment mechanism provides a tight connection to the bag surface, enabling patient-specific placement for the catheter port on the bag. The Pouch Pal represents a significant advancement in neonatal ostomy care, promising to enhance patient outcomes, reduce the burden on healthcare workers, and improve the overall efficiency of refeeding procedures.