SURGERY
Advances and Answers in Pediatric Health
2 Inventions in: Pediatric Surgery
Is there a better way to secure
gastrostomy buttons and central venous
catheters than tape and gauze?
Pediatric surgeon Steven Moulton, MD, places a lot
of gastrostomy buttons. Most pediatric surgeons do.
Worldwide, about 2.5 million of these feeding tube
devices will be placed or replaced this year. That figure
is expected to exceed 3.5 million by 2021.
“And they’re fraught with problems,” says Dr. Moulton, who also
serves as Director of Children’s Hospital Colorado’s Trauma and
Burn programs. “If you make a new hole in the stomach, it’s going
to leak. The gastric contents are acidic, which can cause a skin rash.
It’s moist, so that can lead to a skin infection. And gastrostomy
buttons can be accidentally dislodged. I often overhear nurses on
the phone with parents, who have constant problems with these
devices. And the only things we’re giving parents to secure them
are tape and gauze. I thought, ‘There has to be a better way.’”
1. The Button Huggie
A $25,000 seed funding grant was enough to pull together a team
of mechanical engineering graduate students at the University of
Colorado Boulder. The problem was a complicated one.
“We had to balance securing the gastrostomy button with
facilitating changing the gauze pad and stabilizing the device.
It needed to provide ventilation for the gastrostomy site, and it
had to be childproof. We also wanted at least one component to
be reusable,” says Dr. Moulton. “We went through hundreds of
iterations. Hundreds.”
One discovery, suggested by research assistant Tyler Mironuck,
was an inner structure that acts as a guide for securing the
gastrostomy device and facilitates replacing the gauze sponge
around the button’s stem.
The resulting device, known as the Button Huggie, won the
Children’s Colorado Center for Innovation Challenge in 2019,
providing an additional $40,000 in funding. These funds are being
used to support a 200-patient clinical trial that will start this fall at
several pediatric hospitals, including Children’s Colorado, Phoenix
Children’s, Primary Children’s and Stanford Children’s.
2. The Snuggie
Under Food and Drug Administration rules, the Button Huggie didn’t
count as a new device, since its purpose was to secure a device that
was already cleared by the FDA. That saved considerable time and
expense in the approval process. And it got Dr. Moulton thinking:
What other surgical devices need to be secured?
One obvious choice was external tunneled central venous
catheters, which are inserted in a vein to facilitate access for
chemotherapy, lab draws and a host of other applications. These
are held in place by a Dacron cuff under the skin. Over the course
of about four weeks, subcutaneous tissue grows into the cuff and
secures the catheter. The trouble is those four weeks.
“And if the patient is sick or immunocompromised it could be eight
weeks or longer,” says Dr. Moulton. “And in the meantime, the catheter
is just dangling, waiting to get caught on something.”
There’s also the risk of bacteria migrating up the catheter and
around the unsecured cuff, infecting the bloodstream.
With a $25,000 grant from the Children’s Hospital Colorado Center
for Children’s Surgery, Dr. Moulton assembled another team at
CU Boulder with a new challenge and a new set of requirements.
The securement device could not change the method nurses were
familiar with for dressing the exit site. Nor could it crimp or in any
way damage the catheter, which could cause blood leakage or
infection or require an operation to replace the damaged catheter.
“The design we came up with is completely separate from the exit
site, so it doesn’t change the method of dressing at all,” Dr. Moulton
says. “And it simplifies the management of the hub and greatly
reduces the chances of dislodgement.”
A 20-patient clinical trial to test the first Snuggie prototype device
will start in the next month or two. •
The design of the Button
Huggie, created to secure
gastrostomy buttons,
went through hundreds
of iterations.
The Snuggie secures
external tunneled
central venous
catheters without
interfering with
dressing changes.
7