Children with rare birth defect are breathing easier with device made at Georgia Tech

Children with TM may breathe noisily, have chronic coughing, wheezing, frequent airway infections such as pneumonia or bronchitis, shortness of breath or difficulty swallowing. Most cases are diagnosed when the child is 2-3 months old and improve on their own within two years.

For severe cases, the traditional treatment is a tracheostomy, a surgery to insert a breathing tube into the patient’s neck. In general, breathing through the tube carries a 1% death risk for children each year it’s used, according to Steven Goudy, an ear, nose and throat doctor at Children’s Healthcare of Atlanta. More serious cases carry a higher death rate, he said.

To avoid the need for a permanent breathing tube, biomedical engineers at Georgia Tech used 3D printing technology to custom design an airway stent for Justice based on a CT scan of her collapsed airway. Goudy and a team of specialists at Children’s Pediatric Technology Center (PTC) at Georgia Tech then implanted the device outside her trachea to hold it open.

Credit: Rob Felt

Credit: Rob Felt

The airway splint is made from a bioabsorbable material that will grow with the child before degrading and being absorbed. By then, doctors expect the child’s airway to remain open on its own.

Children’s is one of just four medical centers in the nation offering the device.

Justice was among five patients at Children’s who received the experimental splint over the past six years as part of a “humanitarian use” exception by the U.S. Food and Drug Administration, which approves medical devices. Four of the patients, including Justice, were able to wean off oxygen after receiving the device, according to a study published last year in the International Journal of Pediatric Otorhinolaryngology.

While she’s only 4, Justice shares that she can smell peppermint at her day care because of a “magical” treatment.

One patient wasn’t as fortunate. Despite the implanted device, the infant died after significant respiratory complications. The patient was one of two in the study with tracheobronchomalacia (TBM), which occurs when both the trachea and the bronchial tubes, the airways leading to the lungs, collapse.

While severe TM can cause life-threatening, near-complete airway collapse, the study estimated an 80% death risk for those with severe TBM. Still, the study concluded that the device could greatly benefit patients with severe, unrelenting TM or TBM. Justice is proof.

“It’s good news that patients of Georgia have this technology,” Goudy said. The alternatives aren’t very promising. One child with severe breathing issues who could use the technology has been at another children’s hospital for two or three years, he said.

But Justice was able to return home just a month after her surgery. “Ultimately she’s full of energy with a big personality,” said her mom, Emanuella. Justice’s twin, Journee, didn’t develop the rare disorder.

Northside Hospital, where they were born, noticed the defect even before Justice was born. She was later cared for in the neonatal unit there before further treatment at Children’s. “She was so tiny, and all the tubes were everywhere,” Emanuella recalled. “Every day was a roller coaster.”

Because little was known about the experimental treatment, Emanuella and her husband Jean, both trained as software engineers, had to trust the technology. The medical team also reassured them consistently. “We went on faith; faith in the team and our individual faith that it would work. … It’s still amazing that she has this [device] inside her body and it is growing with her.”

Emanuella admits they took a risk agreeing to the treatment. “No one wants their child to be a guinea pig or be the first at anything, but someone needs to be the first in order to save the rest.”

The alternative is “so scary to think about,” she said. “We are just grateful and enjoy the moments we have. With every year, our confidence grows.”

Justice continues to take medicine and uses a machine that helps clear mucus from her lungs, her mom said. Otherwise, she’s an energetic child who can write her name, knows simple math, enjoys dancing, singing, soccer, and swimming.

Another patient at Children’s is expected to receive the airway device at the end of August, said Scott Hollister, a biomedical engineer and lead developer of the 3D splint, who works with Children’s Pediatric Technology Center at Georgia Tech.

Hollister helped develop a previous version of the airway device at the University of Michigan before coming to Georgia Tech in 2017. But initial studies on the original device convinced the Georgia Tech team to modify the design to allow for growth as the child’s airway expands.

The new design will require further testing before it can be approved by the FDA for general use. Hollister predicted the device could be on the market in three years and benefit 200 to 500 patients each year.

Georgia Tech’s collaborations with a handful of research partners in Atlanta and nationwide also is leading to other new 3D biomedical devices.

For instance, Hollister is working with Children’s and Emory University to 3D print covers that can easily be slipped on or off to prevent blood infections that might occur when tubes are placed into a chest vein to deliver medicine to cancer patients.

Preclinical animal testing is underway at Emory on 3D-printed cardiac patches that can be used as heart tissue. Hollister also is working with Emory Midtown on 3D printing for breast reconstruction after a woman has a mastectomy to remove breast cancer.

Editor’s note: This story was updated to better describe baby Justice Altidor’s physical condition in the first paragraph.