The History of the Button Huggie
Gastrostomy tube or button placement is the third most common non-cardiac, in-patient surgical procedure performed in children in the US.1 These devices provide a secure route for nutrition, medications, and fluid therapy for patients with complex medical needs. The most common type of gastrostomy device placed in children is a gastrostomy button (g-button). These devices help children maintain body weight or facilitate weight gain, correct nutritional deficiencies, hydrate, provide medication(s), and improve their quality of life. Unfortunately, a variety of distressing problems often complicate healing and maintenance of the gastrostomy tract. These include pain and discomfort, leakage, infection, granulation tissue formation and accidental dislodgement. All of these problems are related to excessive movement of the g-button in the tract. G-buttons are also associated with uncommon but life-threatening complications. The Pennsylvania Patient Safety Authority reported approximately 4% of gastrostomy tubes placed in the state caused serious patient harm, which they defined as peritonitis, sepsis, or death.2
Given the frequency and significance of these complications the American Society for Parenteral and Enteral Nutrition (ASPEN) published a monograph entitled, “Safe Practice for Enteral Nutrition”, and strongly recommended some form of external securement for g-buttons.3 And yet, despite this recommendation, no commercially available device appeared on the market. Following initial g-button placement parents and caregivers have traditionally been instructed to use gauze and tape--the so-called “Tic-Tac-Toe” dressing--to secure their child’s g-button and manage peristomal drainage. As a result, g-button complications persist, which we viewed as both a challenge and an opportunity. Thus, over the past three years, Dr. Steve Moulton has collaborated with Tyler Mironuck and the CU Graduate Design Program in Mechanical Engineering to develop the Button Huggie: a precision-designed, low-profile g-button securement device.
More than 1 million g-buttons are placed or replaced throughout the world each year, including more than 250,000 in the US and more than 2,000 per year at Children’s Hospital Colorado. Given the frequency, invasiveness, and broad clinical indications for the placement of these devices, it is not surprising to learn that emergency department (ED) visits and hospital readmissions are common after g-button placement in children. Goldin et al4 found that 8.6% of children who underwent g-button placement had a g-button-related ED visit and 3.9% were readmitted within 30 days for a g-button site infection (26.6%), mechanical g-button complication (22%), or need for g-button replacement (19.4%). Landisch et al5 noted that early laparoscopic g-button dislodgement (< 6wks) occurred in 7.6% of patients, with an average IR (interventional radiology) cost for replacement of $7,105.
Although gastrostomy feedings are effective, maternal caregivers of chronically ill children with a gastrostomy spend on average 8 hours/day in their child’s care, compared to 3 hours/day for non-gastrostomy dependent children.6 Studies on families of children with gastrostomy tube feedings report high levels of burnout and stress.7 Adjusted for inflation, the annual cost associated with the care of gastrostomy devices is $51,000 per patient, or more than $1.5 billion/year.
- HCUPnet. Utilization project: agency for healthcare research and quality. Rockville, MD: United States Department of Health & Human Services; 2009.
- Michelle Feil. Dislodged Gastrostomy Tubes: Preventing a Potentially Fatal Complication Pennsylvania Patient Safety Advisory, Vol. 14, No. 1—March 2017;14:9-16. http://patientsafety.pa.gov/ADVISORIES/documents/201703_dislodgedGI.pdf
- Boullata JI, Carrera AL, Harvey L, Escuro AA, Hudson L, Mays A, McGinnis C, Wessel JJ, Bajpai S, Beebe ML, Kinn TJ, Klang MG, Lord L, Martin K, Pompeii-Wolfe C, Sullivan J, Wood A, Malone A, Guenter P, ASPEN Safe Practices for Enteral Nutrition Therapy Task Force, American Society for Parenteral and Enteral Nutrition. ASPEN safe practices for enteral nutrition therapy. JPEN J Parenter Enteral Nutr. 2017 Jan;41(1):15-103. Epub 2016 Nov 5
- Goldin AB, Heiss KF, Hall M, et al. Emergency Department Visits and Readmissions among Children after Gastrostomy Tube Placement. J Pediatr 2016;174:139-45.
- Landisch R, Colwell RC, Densmore JC. Infant gastrostomy outcomes: The cost of complications. J Pediatr Surg 2016; 51: 1976–1982.
- Heyman MB, Harmatz P, Acree M, Wilson L, Moskowitz JT, Ferrando S, Folkman S. Economic and psychologic costs for maternal caregivers of gastrostomy-dependent children. J Pediatr 2004;145(4): 511-516.
- Pedersen SD, Parsons HG, Dewey D. Stress levels experienced by the parents of enterally fed children. Child Care Health Dev. 2004 Sep;30(5):507-13.