To perform a series of life-saving operations on a newborn girl, Adele Evans, M.D., needed a special type of small plastic tube to help the baby breathe. Trouble was, there was no such device.
So Evans, a pediatric ear, nose and throat specialist at Wake Forest Baptist Medical Center, opted to make one herself. Her hand-made device worked, allowing the infant to breathe during hours of delicate surgeries and for weeks afterwards.
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. They in turn conferred with a local medical device manufacturer to see if and how such an item could be made.
But as the baby grew and her condition became more medically complex, the improvised breathing tube’s effectiveness decreased. A professionally made device was needed, immediately.
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 after that, she went home with her family, just in time for Christmas.
Today, Wake Forest Baptist is planning to test Evans’ invention to determine if it can help other patients.
Madi Pope was brought to the Neonatal Intensive Care Unit at Wake Forest Baptist’s Brenner Children’s Hospital the day she was born last June because she had serious difficulty swallowing and breathing. Examination revealed that she had a laryngotracheoesophageal cleft, a rare congenital defect of the larynx (voice box), trachea (windpipe) and esophagus (passage to the stomach) that allows food or fluid to get into the airway and damage the lungs. This potentially fatal condition required reconstructive surgery.
To perform the challenging procedures, Evans needed to secure the infant’s airway so she could breathe properly with the aid of a ventilator. The standard way to do this would be intubation, the insertion of a flexible single-channel tube through the mouth and down the throat to the point where the trachea branches into the left and right bronchi, the passages to the lungs. But this tiny child had no tracheal wall to keep the air in the lungs and out of the esophagus and stomach. She needed a tube that bifurcated, or split, into two smaller tubes that would extend into her bronchi and deliver air into her lungs.
But that type of tube didn’t exist.
“I’d never seen one, nobody at the hospital had either, and there was nothing like it in any of the medical supply catalogs,” Evans said. “It was pretty clear there was no such thing.”
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 then placed the two smaller (2.5 mm diameter) tubes into the larger (6 mm) one, secured and sealed the assembly with Krazy Glue. 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.”
She realized, however, that while her invention worked well it was probably only a stopgap measure. So she again contacted product innovation services at Wake Forest Innovations to see if a smaller, more sophisticated version could be made.
The task was assigned to Mohammad Albanna, Ph.D. He assessed Evans’ need – a bifurcated tube with an upper (tracheal) segment narrower than her hand-made model’s but wider lower (bronchial) segments and smoother interior and exterior surfaces – 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.
That evaluation process was still in progress in mid-September when Evans called Albanna to inform him that the baby girl’s condition had become complicated by a bleeding disorder and swelling that constricted her repaired airway. This rendered a traditional tube ineffective, and the hand-made device was too large to use. Evans asked if she could get the smaller tube right away.
The U.S. Food and Drug Administration has strict regulations regarding the use of manufactured medical devices on patients, so Albanna quickly but carefully reviewed the relevant federal guidelines to see if a Cathtek-made tube would qualify for a custom-device exemption from the normal – and lengthy – federal approval process. He determined that it would, and contacted the company to see if it could do the job.
Cathtek went right to work. Two 3 mm-diameter tubes were placed side-by-side on a stainless steel rod called a mandrel and wedged into the end of a 4 mm-diameter tube. The rod was then heated sufficiently to fuse the three tubes together by melting, which created a seamless, airtight junction that required no additional adhesive or sealant.
“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.
The finished device was delivered to Evans the next day, and she immediately used it to re-intubate the baby. It worked – and kept working for 19 days, when it was removed because young Madi was able to breathe on her own.
In November, Evans requested two more custom-made devices from Cathtek through Wake Forest Innovations. One, to accommodate changes in the infant’s airway, was a modified version of the first tooled device, with slightly narrower (2.5 mm) bronchial segments. The other, to allow a surgical procedure creating an opening through the neck into the windpipe, was an existing tracheostomy tube shortened and smoothed to Evans’ specifications based upon the baby’s needs. Both of these also proved successful.
On Dec. 22 little Madi, not yet six months old, was discharged from the hospital, much to the relief and delight of her parents, Megan and Matthew Pope of Advance.
“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,” Matthew Pope said. “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.”
After hearing about Evans’ innovation and its successful use, three of her fellow physicians – Thomas Pranikoff, a pediatric surgeon; Neal Kon, chair of cardiothoracic surgery; and Doug Ririe, head of pediatric and cardiothoracic anesthesia – expressed interest in using the device in their specialties. Consequently, Evans, Pranikoff and Ririe are developing a plan for rigorous testing of the device and a clinical trial, to be conducted later this year.
A provisional patent application for the low-profile bifurcated endotracheal-endobronchial tube listing Evans as the inventor has been filed with the U.S. Patent and Trademark Office, and Wake Forest Innovations will support the development and commercialization of the device as warranted.
Meanwhile, Evans and her partners in the device’s creation, production and use can take pride in being part of something truly special.
“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 image a better illustration of what we do, and why we do it.”