This paper describes a novel percutaneous ultrasound gastrostomy (PUG) procedure and the CoapTech point-of-care ultrasound magnet-aligned gastrostomy (PUMA-G) device, which were developed to allow the placement of gastrostomy tubes by physicians across a variety of specialties, using ultrasound equipment found in many nonspecialized medical locations while consuming fewer resources. The current practice for the placement of gastrostomy tubes requires highly specialized equipment and trained physicians, which can delay the performance of the procedure or make it inaccessible in some locations. The PUMA-G device consists of an orogastric catheter with a balloon that encloses a magnetic bar at its distal end and an external, handheld magnet. The orogastric tube is passed through the mouth or the nose and into the stomach. The external magnet is then used to maneuver the balloon to the desired location in the stomach, with feedback and guidance from real-time ultrasound visualization. The novelty of this approach is the use of magnets to create the static compressive force needed for coaptation, in which the stomach is pushed flush against the abdominal wall, allowing ultrasound visualization of the entire gastrostomy tract (skin to stomach), safe cutaneous puncture, and guidewire-assisted placement of the gastrostomy tube. The development of the PUMA-G device has been aided by benchtop and simulation testing in addition to canine and human cadaver studies. The PUMA-G device was used successfully in 29 of 30 cadaver tests, with the one failure attributed to operator error and not the device. Further testing in live patients will assess the safety of the procedure, the speed with which it can be completed, the cost savings, and other benefits the device might offer over the existing gastrostomy procedures.
|Original language||English (US)|
|Journal||Journal of Medical Devices, Transactions of the ASME|
|State||Published - Jun 1 2019|
ASJC Scopus subject areas
- Medicine (miscellaneous)
- Biomedical Engineering