Percutaneous Ultrasound Gastrostomy (PUG): Engineering and Feasibility Assessment of a Pediatric Device

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The goal of this project is to test a potentially safer, more accessible method for placement of gastrostomy feeding tubes in pediatric patients. Millions of patients worldwide require enteral nutrition, and hundreds of thousands of gastrostomy (feeding tube placement) procedures are performed annually in the United States alone, over 10,000 of which are in children. The current standard of practice for placement of nearly all feeding tubes worldwide is called the Percutaneous Endoscopic Gastrostomy (PEG) method. PEG is costly, complex, and potentially risky to perform, as it is performed in a surgical suite about 85% of the time, requiring specialty providers and sophisticated imaging instruments. Open surgical gastrostomy is another alternative, but is more invasive. We have invented a new device and method, using magnets and low-cost, non-invasive ultrasound, called the Point-of-Care Ultrasound Magnet Aligned Gastrostomy (PUMA-G) device, which will improve and simplify the gastrostomy procedure on many dimensions. The PUMA-G device is applied using the Percutaneous Ultrasound Gastrostomy (PUG) procedure. The most important difference between our method and PEG, is that the PUMA-G device will eliminate several safety risks of PEG while also allowing up to 80% of all gastrostomy procedures to be performed at the patient’s bedside - without specialist consultants, expensive imaging, and surgical suite time (for the remaining 20% of cases, the PUMA-G device will be contraindicated, and a conventional PEG or open surgical gastrostomy may be performed). Migration of methods from the surgical theatre to the patient bedside has successfully occurred for many different specialty procedures over the previous two decades, and in each instance has led to substantially reduced cost and improved patient satisfaction, with comparable or better safety outcomes. PUMA-G has been designed, built, and tested successfully in adults, with over 15 successful live canine experiments and 6 live human patient cases to date. Recently, many world-class pediatricians who have seen the PUMA-G device have recognized it as a superior method for use in children, and have requested a PUMA-G device be built which is sized and designed for use in smaller patients. This project will design, test, and validate in a live rabbit model a smaller PUMA-G device for safer and less costly ultrasound gastrostomy in children.