Pediatric Gastrojejunal Feeding Tube (GJ-tube) Cleaner
Department of Health and Human Services
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Small Business Information
ACTUATED MEDICAL, INC.
310 ROLLING RIDGE DR, BELLEFONTE, PA, -
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): Long-term enteral nutrition, via a feeding tube, is often provided to pediatric patients who have a functioning gastrointestinal tract but are at risk of malnutrition due to their inability to properly ingest nutrientsorally. Enteral feeding can be accomplished by surgically implanting a percutaneous feeding tube that provides access to the stomach, small intestine, or both. Occlusion of the tubes is a regular complication, particularly with the long, small diameter tubes that access the small intestine (J- or GJ-tubes). Bacterial and fungus growth along the tube wall is another serious issue that can accelerate tube degradation and significantly reduce tube life. When patency cannot be restored by conventional means (syringe flush and/or chemical treatments), the child must be admitted to a hospital to have the tube surgically removed and replaced with a new one. This disruption of nutrition is a very time-consuming, expensive and agonizing experience for the child and caregivers. In this NIH SBIR program, Piezo Resonance Innovations Inc. (PRII) will develop and conduct preliminary testing for safety and efficacy of the Pedi-GJ Tube-ClearTM, an active pediatric gastrojejunal feeding tube (GJ-tube) cleaner that cleans efficiently while the tube remains in the patient, in-situ. The device will be designed to break up feeding tube clogs, restore patency, and clean walls - reestablishing nutrition and medication support quickly to an ill child. In Phase I, PRII will explore micro-actuation technologies in optimizing the Pedi-GJ Tube-ClearTM prototype. The efficacy of the prototype will then be evaluated by clinicians. A preliminary evaluation of device safety will also be performed in a porcine model near the end of the 9-monthproject. The pediatric feeding tube cleaner will extend the life of implanted feeding tubes, improving patient comfort and health while providing parents and nursing staff greater peace of mind. Phase I Hypothesis: The Pedi-GJ Tube-ClearTM prototype willremove 90% of simulated obstructions and restore patency without causing dislodgement or damage to the tube. Specific Aims: 1. Build a Pedi-GJ Tube-ClearTM prototype that can be inserted into clinical GJ-tubes. 2. Demonstrate that the Pedi-GJ Tube-ClearTM prototype can remove obstructions and clean the inner wall without damage or dislodgement of the GJ-tube with in vitro model. 3. Demonstrate the device can be operated in vivo without causing tube dislodgement or damage to the intestinal or stomach wallsvia endoscopic observation and histological analysis. Expected Outcomes: Test data (in-vitro and in vivo) that verifies that the Pedi-GJ Tube-ClearTM device is safe and effective in clearing obstructions in 10Fr GJ-tubes. PRII will manufacture the devicein its FDA compliant, ISO 13485-certified facility in Bellefonte, PA. PRII is in discussions with three potential strategic partners in the enteral feeding market for sales/marketing/distribution. PUBLIC HEALTH RELEVANCE: Long-term feeding tubes areneeded to provide nutrition to children who cannot digest food orally. For gastrojejunostomy (GJ) tubes, specifically designed to access the small intestine, clogging rates as high 35% occur. Long term degradation due to bacteria and fungus colonization in the feeding tube is also a major concern. If a clog cannot be removed by conventional approaches, the tube must be surgically removed and replaced - a very time-consuming, expensive and agonizing experience for the child and parents. The goal of this project is a simple, non-surgical intervention option for reestablishing and maintaining patency and cleanliness in pediatric GJ feeding tubes while the tube remains in the patient.
* information listed above is at the time of submission.