April and Bryan Gionfriddo's 6-month-old son, Kaiba, wasn't breathing, and the prognosis wasn't good.
Kaiba had tracheobronchomalacia, a condition that caused his airways to close and caused his face to turn blue. A ventilator kept him alive temporarily, but doctors were doubtful he'd make a full recovery.
Tracheobronchomalacia affects about 1-in-2,200 infants born in the United States. Often, babies can grow out of it by the time they are 2 or 3 years old. But Kaiba's case was one of the worst doctors at the hospital had ever seen.
"In Kaiba's case, it would have been fatal," says Dr. Glenn Green, who performed Kaiba's surgery. "We had to come up with a novel treatment, it was a very complex case."
A small piece of plastic turned out to be the key to saving his life.
Kaiba became the first person to have his life saved by a 3-D printed device: Doctors at the University of Michigan's C.S. Mott Children's Hospital designed a customized splint that opened his airways and saved his life. The details of Kaiba's case were published Wednesday in the New England Medical Journal.
Green and Scott Hollister, a biomedical engineer, had been working on medical applications of 3-D printing for several years, but never on a human patient. The team asked for, and received, emergency Food and Drug Administration approval to use the stint. They thought it had about a 50-50 chance of working.
"Honestly, we had never heard of 3-D printing before until they mentioned it at the hospital," Gionfriddo says. "At that point, it seemed like the only thing that could work, there was no other option."
Hollister took a CT scan of Kaiba's chest and, using computer design software, created a splint that would perfectly attach to his trachea. Within a couple days, the device was ready to be surgically implanted.
Within minutes of having the splint implanted, Kaiba began breathing. Within three weeks, he was completely off a ventilator.
The case represents the latest breakthrough for 3-D printing, an emerging technology that allows engineers to create physical objects from computer-designed blueprints. 3-D printers have been used to make guns, statues and toys – NASA even wants to use them to create food. But perhaps their most promising application lies in the medical industry.
3-D printers have been used to create skull implants, teeth and rudimentary organ replacements. Green is working on creating nose, ear and jawbone replacements for children born without them or who lost them due to cancer or accidents.
"There are no definite limits on what it can do now," Green says. "In this case, we were able to put very specific engineering properties into a device that could not have been done with something that was jury-rigged by hand."
In the future, most hospitals might have a 3-D printer in order to create customized devices that could save patients' lives. Rather than sending a plaster cast to a factory somewhere, a process that can take months, they could be made in-house in the matter of hours or days.
"Traditionally, if you wanted something done quickly, you'd have to do make something by hand," Green says. "If you got something from a factory, it's either not patient specific or takes a long time."
The upsides, Hollister says, are obvious.
"You can make complex, customized things for a patient's anatomy, and you can build them rapidly from a CT scan image," he says. "Ours isn't the first 3-D device printed, but it's the first used in a life-or-death situation. I think as the technology advances, you'll see whole engineering groups at some hospitals."
Green and Hollister have spent the greater part of the last year looking for wider FDA approval. They were only able to get emergency clearance from the FDA because Kaiba's case was a life-or-death situation and his parents signed a waiver.
Since implanting the splint into Kaiba more than a year ago, he's been breathing normally. The family has gone back to their Youngstown, Ohio home. He still sees Green every three months, but there was very little follow-up care needed. He should be able to breathe normally after the device dissolves and is otherwise a healthy toddler.
"He's doing wonderful," Gionfriddo says. "He's been breathing well."