CoapTech, LLC — Department of Health and Human Services SBIR Phase I: 300

Description

The goal of this project is to test a potentially safermore accessible method for placement of gastrostomy feeding tubes in pediatric patientsMillions of patients worldwide require enteral nutritionand hundreds of thousands of gastrostomyfeeding tube placementprocedures are performed annually in the United States aloneoverof which are in childrenThe current standard of practice for placement of nearly all feeding tubes worldwide is called the Percutaneous Endoscopic GastrostomyPEGmethodPEG is costlycomplexand potentially risky to performas it is performed in a surgical suite aboutof the timerequiring specialty providers and sophisticated imaging instrumentsOpen surgical gastrostomy is another alternativebut is more invasiveWe have invented a new device and methodusing magnets and low costnon invasive ultrasoundcalled the Point of Care Ultrasound Magnet Aligned GastrostomyPUMA Gdevicewhich will improve and simplify the gastrostomy procedure on many dimensionsThe PUMA G device is applied using the Percutaneous Ultrasound GastrostomyPUGprocedureThe most important difference between our method and PEGis that the PUMA G device will eliminate several safety risks of PEG while also allowing up toof all gastrostomy procedures to be performed at the patient s bedsidewithout specialist consultantsexpensive imagingand surgical suite timefor the remainingof casesthe PUMA G device will be contraindicatedand a conventional PEG or open surgical gastrostomy may be performedMigration of methods from the surgical theatre to the patient bedside has successfully occurred for many different specialty procedures over the previous two decadesand in each instance has led to substantially reduced cost and improved patient satisfactionwith comparable or better safety outcomesPUMA G has been designedbuiltand tested successfully in adultswith oversuccessful live canine experiments andlive human patient cases to dateRecentlymany world class pediatricians who have seen the PUMA G device have recognized it as a superior method for use in childrenand have requested a PUMA G device be built which is sized and designed for use in smaller patientsThis project will designtestand validate in a live rabbit model a smaller PUMA G device for safer and less costly ultrasound gastrostomy in children The PUMA G system is a novel medical device allowing gastrostomyfeeding tube insertionwith solely minimally invasive ultrasound imagingin adultsIn order to leverage the safety and efficiency advantages of the PUMA G potential in childrenpediatricians have requested CoapTech devise a PUMA G device for their patients most commonly indicated for G tubesandltyrs oldCoapTech will work with clinical experts and patient family advocates torigorously devise functional design requirements for a PUG device intended for patients andltkgserially test prototypes in benchtop settings to verify needs are metandassess the feasibility and tolerability of a final prototype in a pediatric rabbit model