Collaboration Leads to Invention of Potentially Lifesaving Medical Device at Wake Forest Baptist

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 afterwards.


“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 WakeForest 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 Christmas.


“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.


“This collaboration 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.”


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