In-Patient Pediatric Gastrojejunal Tube Cleaner Eliminating Surgical Intervention

DESCRIPTION provided by applicant In this Phase II NIH SBIR Actuated Medical Inc will complete the development of the Pedi GJ ClearTM device for clearing occlusions and restoring patency in situ to pediatric gastrojejunal feeding tubes GJ tubes eliminating the need to surgically replace clogged tubes Public Health Problem Enteral nutrition is provided for patients that have a functioning lower gastrointestinal tract but are unable to orally ingest nutrients and are at risk of malnutrition Conditions necessitating long term enteral nutrition include prematurity gastrointestinal dysfunction cancer treatment neurological disorders heart disease and congenital metabolic abnormalities When long term enteral access is needed percutaneous gastrostomy jejunostomy or gastrojejunal tubes can be surgically placed Reported clogging rates of GJ and J tubes have been as high as mainly due to the small bore considerable length and convoluted geometries for placement Degradation of the tube due to fungal growth is another major issue Furthermore young pediatric patients tend to exhaust energy reserves very quickly and are highly susceptible to the dehydration and hypo and hyper glycemia that can result from a clogged tube In the U S infants and children are dependent on narrow bore feeding tubes The Pedi GJ Clear reliably clears occlusions and maintains feeding tube patency while the tube remains in the child The Pedi GJ Clear operates around tight curves in long narrow tubing without risk to bowel tissue tube dislodgement or tube integrity The patent pending catheter based device employs a flexible wire in a smooth catheter and an irrigation mechanism optimized to clear obstructions quickly restoring patency and cleaning inner walls The project goal is a non surgical intervention option for patency re establishment in obstructed pediatric GJ tubes that is low cost and easy to operate A routine maintenance cleaning will ultimately be included in patient care to maintain wall cleanliness and reduce tube degradation due to fungus and bacteria growth Other indwelling tubes that suffer from occlusions and deterioration will be later targets for development and commercialization with the base platform technology Phase I proved feasibility of the Pedi GJ Clear to clear occlusions and met the Specific Aims Reviews by practicing clinicians were extremely positive and have been used to guide the Phase II Beta prototype design requirements Phase II Hypothesis The Pedi GJ Clear will safely restore patency to occluded GJ tubes in patient with a success rate of at least in a pilot human clinical trial n Additionally porcine testing n e confirms safety and efficacy t a success rate e Specific Aims Integration of final design features including irrigation and electronics Fabrication and Design Verification Design Validation and Pilot Human Clinical Evaluation PUBLIC HEALTH RELEVANCE Enteral nutrition is provided for patients that have a functioning lower gastrointestinal tract but are unable to orally ingest nutrients and are at ris of malnutrition When long term enteral access is needed gastrojejunal GJ tubes can be surgically placed Reported clogging rates of GJ and J tubes have been as high as mainly due to the small bore considerable length and convoluted geometries Degradation of the tube due to fungal growth is another major issue Furthermore young pediatric patients tend to exhaust energy reserves very quickly and are highly susceptible to the dehydration hypo and hyper glycemia that can result from a clogged tube In this Phase II SBIR Actuated Medical Inc will complete the development of an the Pedi GJ Clear device for clearing obstructions and restoring patency in patient to pediatric gastrojejunal feeding tubes GJ tubes eliminating the need to surgically replace clogged tubes and reducing tube degradation due to fungus and bacteria growth