The day Madi Pope was born last June, she has had serious difficulty swallowing and breathing. To help her, her doctors transferred her to the Neonatal Intensive Care Unit at Brenner Children’s Hospital www.brennerchildrens.org, part of the Wake Forest Baptist Medical Center www.wakehealth.edu.
Examination revealed that she had a rare congenital defect of the larynx, trachea, and esophagus called laryngotracheoesophageal cleft. It causes food or fluid to get into the airway and damage the lungs, can be potentially fatal, and requires reconstructive surgery.
To perform a series of life-saving operations on the newborn, Adele Evans, M.D., a pediatric ear, nose, and throat specialist at Wake Forest Baptist, needed a special type of small plastic tube that could split into two smaller tubes to help the baby breathe. Unfortunately, there was no such device.
Because of the baby’s condition, normal intubation with a single-channel tube wouldn’t work. So Dr. 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, and 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.
Recognizing that her improvised device could be improved upon, Evans reached out to product innovation services at Wake Forest Innovations www.wakeforestinnovations.com, 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 the device manufactured in consultation with Cathtek Inc., www.cathtek.com a Winston-Salem company that makes catheters and related medical accessories.
However, 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 as a professionally made device was needed immediately.
Cathtek in less than two days provided Dr. Evans with a custom-made tube, which she immediately used. Less than three weeks later following successful surgery, the baby girl was able to breathe on her own and two months later, she went home with her parents.
A provisional patent has been filed. Wake Forest Baptist is developing a plan for rigorous testing of the device and a clinical trial will be conducted later this year to determine if it can be used to help other patients.