Baby's life saved by 3D-printed tracheal splint

4 June 2013

Doctors at the University of Michigan have saved the life of a 20-month-old baby with a collapsed trachea by printing a custom designed splint based on a CT scan of his trachea. See video below.

Dr Glenn Green, associate professor of pediatric otolaryngology at the University of Michigan and Dr Scott Hollister, professor of biomedical engineering and mechanical engineering and associate professor of surgery obtained emergency clearance from the US FDA to create and implant a tracheal splint made from the biopolymer polycaprolactone.

The splint was sewn around the baby's airway to expand the bronchus and give it a skeleton to aid proper growth. Over about three years, the splint will be reabsorbed by the body. The case is featured today in the New England Journal of Medicine.

Green and Hollister were able to make the custom-designed, custom-fabricated device using high-resolution imaging and computer-aided design. The device was created directly from a CT scan of Kaiba's trachea/bronchus, integrating an image-based computer model with laser-based 3D printing to produce the splint.

“Our vision at the University of Michigan Health System is to create the future of health care through discovery. This collaboration between faculty in our Medical School and College of Engineering is an incredible demonstration of how we achieve that vision, translating research into treatments for our patients,” says Ora Hirsch Pescovitz, M.D., U-M executive vice president for medical affairs and CEO of the U-M Health System.

“Groundbreaking discoveries that save lives of individuals across the nation and world are happening right here in Ann Arbor. I continue to be inspired and proud of the extraordinary people and the amazing work happening across the Health System.”

Baby Kaiba Gionfriddo was off ventilator support 21 days after the procedure, and has not had breathing trouble since then.

“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,” says Hollister. “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.”

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.

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, are about 10 percent of that number. And they are frightening, says Green. A normal cold can cause a baby to stop breathing. In Kaiba’s case, the family was out at a restaurant when he was six weeks old and he turned blue. Before the device was placed, Kaiba continued to stop breathing on a regular basis and required resuscitation daily.

“Severe tracheobronchomalacia has been a condition that has bothered me for years,” said Green. “I’ve seen children die from it. To see this device work, it’s a major accomplishment and offers hope for these children.”

“Even with the best treatments available, he continued to have these episodes. He was imminently going to die. The physician treating him in Ohio knew there was no other option, other than our device in development here,” Green added.

 

More information

The research has been published in the New England Journal of Medicine: DOI: 10.1056/1 NEJMc1206319

 

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