Using customized, 3D-printed splints, doctors at the University of Michigan’s C.S. Mott Children’s Hospital successfully treated three infants with tracheobronchomalacia, a typically fatal airway disease that causes the windpipe to periodically collapse and prevents normal breathing. A report on the implanted splints was published in the April 29 issue of Science Translational Medicine.
About one in 2,000 babies is born with tracheobronchomalacia. Conventional treatment involves inserting a breathing tube into the patient’s neck, attaching the child to an artificial ventilator, and using sedatives and narcotics to keep the child calm and still. There is no cure for the condition and life expectancies are grim.
“Today we see a way to cure a disease that has been killing children for generations,” senior author Glenn Green, MD, an associate professor of pediatric otolaryngology at C.S. Mott Children’s Hospital, told NBC News.
Green and colleague Scott Hollister, PhD, a professor of biomedical engineering and mechanical engineering and an associate professor of surgery at the University of Michigan (U-M), used 3D printing to create a device that would keep the windpipe open and restore breathing. The experimental airway tubes are made to be stitched to the outside of the trachea, holding the airway open in much the same way a pole holds up a tent.
The researchers used measurements taken from the three patients’ CT scans to produce customized, 3D-printed splints fitted in size and shape for each child. Made of thin layers of plastic, the splints are designed to spread as the trachea grows so they don’t have to be replaced and to be reabsorbed into the body over time.
With emergency clearance from the Food and Drug Administration (FDA) for use of the device, the first 3D splint surgery was performed in 2012 on then 3-month-old Kaiba Gionfriddo.
“The first time he was hospitalized, doctors told us he may not make it out,” Kaiba’s mother April Gionfriddo, said in a news release. “It was scary knowing he was the first child to ever have this procedure, but it was our only choice and it saved his life.”
Following the success of Kaiba’s surgery, the device was implanted in 5-month-old Ian Orbich and 16-month-old Garrett Peterson. None of the children have experienced complications. Three-year-old Kaiba was recently seen for a follow-up appointment and his splint is dissolving as expected. Both Ian and Garrett are also flourishing.
“It’s hard to convey how sick these children were. All of these children had been in the intensive care unit for several months. They all had tracheostomies where breathing tubes were put in their necks,” Green told NBC News.
“Now these children are home with their families. These children are now learning to sit and stand and run as they are no longer sedated,” added Green.
Noting that the device worked better than ever imagined, Green and his colleagues are meeting with the FDA to get approval for a clinical trial involving up to 30 children.