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U-M doctors use 3-D printer to build life-saving device

University of Michigan
April Giofriddo holds her son, Kaiba, who now breathes on his own after U-M surgeons implanted a splint created on a 3-D printer.

An Ohio baby is likely alive today because of the collaborative ingenuity of two University of Michigan doctors and their teams.

Kaiba Gionfriddo has a condition called tracheobronchomalacia – a blockage of the airway to the lungs. The condition affects about 1 in 2,200 babies born in the U.S. Many grow out of it by the time they’re two or three years old. Sometimes the disorder is misdiagnosed as asthma.

Kaiba stopped breathing every day, and his parents, April and Bryan Gionfriddo, were told their child would probably not survive.That’s when two University of Michigan doctors went into action. Glenn Green, a U-M associate professor of pediatric otolaryngology, and Scott Hollister, a U-M professor of biomedical engineering and mechanical engineering and associate professor of surgery, had already been working together to create a tissue-engineered trachea that would be produced on a 3-D printer.

Using high-resolution imaging and computer-aided design, the team made a custom splint for Kaiba and received emergency clearance from the Food and Drug Administration to use it in the child.

“There have been patients before that have had similar problems that have died on us, so it’s been a very scary problem to deal with,” says Green. “We had done a fair amount of preliminary work in devising the splint, and so when an opportunity came for a child that had this problem, we were ready to go with it.”

Kaiba was brought to Ann Arbor by Survival Flight, and on February 9, 2012, the splint was sewn into his airway to expand the bronchus and give it a frame to help it grow properly.

“We were all a little nervous,” Green says. “Scott Hollister made a whole bunch of different sizes (of the splint) in case something unexpected happened or something fell on the floor, because there was no other box that you could go to for more.

“Then we went into the operating room and confirmed how bad the problem was. His chest was opened and he was put on bypass. The sutures were tied through the splint to open up the bronchus, and as soon as that was done, we saw the left lung going up and down for the first time.”

Green says that drew a big cheer in the operating room.

The surgery took about two and a half hours, and less than month after the splint was inserted, Kaiba was completely removed from a respirator and was able to breathe on his own.

Kaiba is now 20 months old.

http://youtu.be/O82nC9ro6Io

“He’s had no more episodes where he’s turned blue. He’s been growing well. He does have some unrelated medical issues that are being worked out now, but we are very pleased with the progress,” Green says.

Kaiba still has a tracheostomy tube in his throat, but that will likely be removed in about two months.

The polymer splint is designed to be absorbed into the baby’s body after two or three years.

Hollister says 3-D printing shows great promise in medicine.

“There’s already one device that’s been approved for cranioplasty – plugging holes in the skull,” he says. “We have used it to build noses and ears that we’re testing in preclinical models with other maxillofacial surgeons at U-M. We can replicate a piece of your facial bone, and implant it with growth factors and cells in the muscle to get blood vessel growth into the structure.

“Then, after a month to two months you can transplant it into the face and hook it up to arteries that’ll be immediately profused with blood,” Hollister explains. “We’ve built a lot of bone structures and we’ve done some spine fusion with these materials. We can basically design a replacement for any piece of anatomy in the body with a biomaterial.”

Green says once CT and MRI scans of the patient are completed, the data is imported into the 3-D printer and the device can be manufactured immediately.

“It’s extremely fast,” Green says. “That’s one of the exciting things – the potential to rapidly manufacture a device for somebody with a life-threatening condition.”

The study is featured in the New England Journal of Medicine: DOI: 10.1056/1 NEJMc1206319