N.C. – April 15, 2015 – The day Madi Pope was born
last June she had serious difficulty swallowing and breathing. Her doctors
transferred her to the Neonatal Intensive Care Unit at Brenner Children’s Hospital,
part of Wake Forest Baptist Medical Center.
Examination revealed that
she had a rare congenital defect of the larynx (voice box), trachea (windpipe)
and esophagus (passage to the stomach) called laryngotracheoesophageal cleft.
It causes food or fluid to get into the airway and damage the lungs. This
potentially fatal condition required reconstructive surgery.
To perform a series of
life-saving operations on the newborn girl, Adele Evans, M.D.,
a pediatric ear, nose and throat specialist at Wake Forest Baptist, needed a
special type of small plastic tube that split into two smaller tubes to help
the baby breathe. Trouble was, there was no such device.
Because of the baby’s
condition, normal intubation with a single-channel tube wouldn’t work. So Evans
decided to improvise, which physicians have the liberty to do in critical
situations. Working at her kitchen table, she used a scalpel to trim the ends
of three endotracheal tubes, placed the two smaller tubes into the larger one,
then secured and sealed it with superglue.
After checking the
device’s stability, Evans built a second one at the hospital the next day and
kept it sterile until she used it to intubate the baby, then 12 days old, for
her first series of surgeries. The hand-made device functioned flawlessly,
allowing the infant to breathe with ventilator assistance during surgery and
“I wasn’t trying to invent
something,” Evans said. “I was just trying to make the baby safe.”
Recognizing that her
improvised device could be improved upon, Evans reached out to product
innovation services at Wake
Forest Innovations, the Medical Center’s commercialization arm.
The task was assigned to
Mohammad Albanna, Ph.D. He assessed Evans’ need and evaluated the possibility
of having such a device manufactured in consultation with Cathtek Inc., a
Winston-Salem company that makes catheters and related medical accessories.
But by mid-September as
the baby grew and her condition became more medically complex, the improvised
breathing tube’s effectiveness decreased. There was no more time for additional
research and development. A professionally made device was needed, immediately.
“That’s not exactly our
normal process but we were aware of what was needed and why, so we were happy
to do what we could as quickly as possible,” said Todd Cassidy, the president
of Cathtek, which provided its services free of charge.
In less than two days,
Evans received a custom-made tube, which she immediately put to use. Less than
three weeks later, following successful surgery, the baby girl was able to
breathe on her own. A little more than two months later, she got to go home
with her parents, Megan and Matthew Pope of Advance, just in time for
“Dr. Evans went out of her
way to handle Madi’s complicated care and to make sure that people in other
areas worked together for Madi,” said Matthew Pope. “We feel that Madi received
110 percent if not more from Dr. Evans. There is not a doubt in our minds that
had it not been for Dr. Evans our daughter would not be alive today.”
With a provisional patent
filed, Wake Forest Baptist is developing a plan for rigorous testing of the
device and a clinical trial, to be conducted later this year, to determine if
it can help other patients.
between a physician, product innovation services and a local company working
together to help save a child’s life – is a sterling example of open innovation
at its finest,” said Eric
Tomlinson, D.Sc., Ph.D., Wake Forest Baptist’s chief innovation officer. “I
can’t imagine a better illustration of what we do, and why we do it.”