April and Bryan Gionfriddo were dining out one night when their six-week-old son, Kaiba, stopped breathing and turned blue.
"He spent 10 days in the hospital and then came home," April said. "Two days later he ended up turning blue on us again, he stopped breathing on us. I prayed every night just hoping he would pull through."
Kaiba was diagnosed with tracheobronchomalacia, which collapsed his windpipe so he could not breathe.
"Quite a few doctors said he had a good chance of not leaving the hospital alive," April said. "It was the most devastating thing a parent could hear. At that point, we were desperate. Anything that would work, that would make him live, we pretty much would take it and run with it."
They found hope at the University of Michigan, where Scott Hollister, PhD, professor of biomedical engineering and associate professor of surgery, 3D printed a splint to open Kaidba's airway.
Glenn Green, M.D., associate professor of pediatric otolaryngology at the University of Michigan then sewed the splint around the outside of Kaiba's airway to expand the bronchus and give it a skeleton to aid proper growth.
The splint, which was made from a biopolymer called polycaprolactone, should be reabsorbed by the body in about three years.
"It was amazing," Green said. "As soon as the splint was put in, the lungs started going up and down for the first time and we knew he was going to be OK."
Kaiba was off ventilator support 21 days after the procedure, and has not had breathing trouble in the 20 months since then.
The procedure was so unprecedented that Green and Hollister had to obtain emergency clearance from the U.S. Food and Drug Administration beforehand.
"This is the first time this procedure has been done anywhere in the world," Green said.
The image-based design and 3D biomaterial printing process can be adapted to build and reconstruct a number of tissue structures. Green and Hollister have already utilized the process to build and test patient specific ear and nose structures in pre-clinical models. In addition, the method has been used by Hollister with collaborators to rebuild bone structures (spine, craniofacial and long bone) in pre-clinical models.
"The material we used is a nice choice for this. It takes about two to three years for the trachea to remodel and grow into a healthy state, and that's about how long this material will take to dissolve into the body," Hollister said. "Kaiba's case is definitely the highlight of my career so far. To actually build something that a surgeon can use to save a person's life? It's a tremendous feeling."
Severe tracheobronchomalacia is rare. About 1 in 2,200 babies are born with tracheomalacia and most children grow out of it by age 2 or 3, although it often is misdiagnosed as asthma that doesn't respond to treatment. Severe cases, like Kaiba's, make up only about 10 percent of all diagnosed cases.
"He has not had another episode of turning blue," April said. "We are so thankful that something could be done for him. It means the world to us."