An innovative device designed to secure gastrostomy buttons recently won the Shark Tank challenge at the 2022 North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) annual meeting.
The Button Huggie, co-invented by Steve Moulton, MD, a professor of pediatric surgery at the University of Colorado School of Medicine, and Tyler Mironuck, an engineering graduate of the Design Center Colorado program at CU Boulder, is designed to reduce or eliminate gastrostomy button dislodgements, excessive movement, leaking, and skin irritation or infection.
A gastrostomy button is a surgical device that is inserted through the abdominal wall and into the lumen of the stomach. Gastrostomy button placement is the third most common non-cardiac, inpatient surgical procedure performed in children in the United States. These low-profile devices help children and adults maintain body weight, stay hydrated, and take medication.
Moulton envisioned the Button Huggie based on what he observed in his patients, as well as hearing from other clinicians and parents or caregivers. They repeatedly reported that excessive movement of gastrostomy buttons is associated with leakage from the tract, skin breakdown, time-consuming dressing changes, and accidental dislodgement.
Since the introduction of the initial prototype several years ago, Moulton and Mironuck have presented the Button Huggie at several academic meetings and medical device competitions around the country. The recent NASPGHAN meeting in Orlando, Florida, was another important opportunity to present the Button Huggie, says Mironuck, only this time to a large group of pediatric gastroenterologists and GI nurses, who provided great reviews and much interest.
“Now one of the key things is getting the word out,” says Mironuck, who presented the Button Huggie at the NASPGHAN conference. “I can’t tell you how many people came up to our booth after the presentation and said, ‘This fills a really big need.’”
Engineering solutions
Throughout his career as a pediatric surgeon, Moulton has placed many gastronomy buttons, or g-buttons. Although the goal for their use is to make things easier for patients, they can cause problems for patients and their caregivers.
“We probably place three to six gastronomy buttons in children each week at Children’s Hospital Colorado,” Moulton says. “But there had been no device to secure them. Families are given tape and gauze and told to put the gauze under the g-button and secure it with four strips of tape, then change the gauze once a day. Tape doesn’t really secure the g-button, however, so it moves side to side and up and down in the gastrostomy tract. This constant movement widens the tract, which leads to leakage of gastric contents, skin breakdown, malodor and soilage of a child’s clothing. Plus, research shows that 7% of g-buttons are accidentally dislodged in the first six weeks after placement.”
With the goal of revolutionizing the way g-buttons are managed, and with support from a CU Department of Surgery Academic Enrichment Fund grant, Moulton partnered with a team of engineering graduate students at CU Boulder in 2017 to develop the Button Huggie. Mironuck was one of the students on this team who took the lead and eventually partnered with Moulton to found EZaLife to market and sell the Button Huggie.
“First and foremost, it needed to be a securement device,” Mironuck explains. “However, in talking with nurses at Children’s Hospital, we identified another pain point: tape. The current standard of care requires removing tape from the skin every time the gauze is replaced, which can cause a rash around that area. So, we started thinking of a way to replace the gauze without having to remove tape every time.”
To solve this issue, the engineering team drew inspiration from ostomy pouches, which are typically a two-component system with a base and a detachable bag. Similarly, they envisioned a two-component system, only with a detachable lid instead of a bag. Opening the lid allows access to the g-button and gauze, so gauze could now be changed without removing any tape.
“One of the other challenges we faced was coming up with a user-friendly way to slide the gauze under the g-button, after the lid is open,” Mironuck says. “There’s not a lot of room underneath a g-button and that, combined with the fact that we wanted to make the Button Huggie as small as possible for our pediatric patients, resulted in very little room to get your fingers in there. So, we came up with a novel internal structure that helps guide the gauze under and around the g-button. This resulted in quick and painless gauze replacements, which can be done in less than a minute.”
Better patient care
Those and other innovations led to the first Button Huggie iterations that filled a significant and previously unmet need. The Button Huggie won first place at the 2019 Children’s Hospital Colorado Innovation Challenge and first place at the 2019 UCSF-Stanford Pediatric Device Accelerator, as well as second place in the 2019 CU Boulder New Venture Challenge.
Moulton and Mironuck founded EZaLife in early 2020 to market the Button Huggie, plus several other medical devices currently in development. Moulton is the principal investigator of an upcoming clinical trial of the Button Huggie at six large pediatric hospitals, in which more than 200 participants will be randomized to use either a Button Huggie or standard tape and gauze to secure their child’s g-button.
"The Button Huggie benefits pediatric and adult patients because they can shower with it, swim with it, work out with it, and only have to change out the adhesive about once a week instead of multiple times a day,” Moulton explains. “Once the tract is mature, it’s less critical that the g-button is secured, but it can take six, nine, 12 months for the gastrostomy tract to become bullet-proof, and some patients can have g-tube site problems for years. Ultimately, our goal is better patient care and to make life as easy and painless as possible for them.”
