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 35%, 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. 3,000 - 5,000 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 0.95 (95%) in a pilot human clinical trial (n = 30). Additionally, porcine testing (n e 30) confirms safety and efficacy t a success rate e 0.95.
Specific Aims : 1) Integration of final design features, including irrigation and electronics, 2) Fabrication and Design Verification 3) Design Validation and 4) Pilot Human Clinical Evaluation.
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 35%, 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.
