Groundbreaking 3D-Printed Pediatric Airway Splints Show Improved Outcomes Over Time
Three years ago, doctors pioneered a 3D-printed medical device that prevented the windpipes of infants and toddlers from collapsing, a symptom of tracheobronchomalacia (TBM). This week, the team released a promising new study that found all three children fitted with the device have experienced long-term benefits.
TBM is extremely rare, but often fatal. Glen Green, one of the developers of the device, blogged that 1 in 2,200 babies are born with tracheomalacia, but that most children grow out of it by age two. More severe cases are much more difficult to treat, and with traditional treatments, these babies must live on mechanical ventilation for a significant portion of their infancy and could experience a number of comorbid conditions.
As an alternative, researchers from the University of Michigan’s C.S. Mott Children’s Hospital (CSMC) in 2012 developed a tiny splint that could hold a child’s windpipe open so that he could breathe properly while his tissue developed.
To produce the device, researcher took high resolution CT scans of the children’s trachea and bronchus and 3D printed each splint to perfectly match each child’s throat. The tiny splints were made out of polycaprolactone, a biodegradable polyester designed to slowly dissolve as the babies’ tracheas grew.
So far, the splints have been implanted in three patients with special emergency clearance from the FDA, and the CSMC team has followed each case to see how the splints were tolerated over time. They published their results in Science Translational Medicine.
“At the time of publication, these infants no longer exhibited life-threatening airway disease and had demonstrated resolution of both pulmonary and extrapulmonary complications of their TBM. Long-term data show continued growth of the primary airways,” the study authors wrote.
In a press release, the team reported that none of the children had experience any complications but said that the study was not designed to be a safety evaluation. Larger and more thorough clinical trials could show some adverse effects, they cautioned.
“We are pleased to find that all of our cases so far have proven to improve these patients’ lives. The potential of 3D printed medical devices to improve outcomes for patients is clear, but we need more data to implement this procedure in medical practice,” Green said.
Green commented in his blog that the idea of a device designed to adjust to tissue growth and dissolve over time held a lot of promise in medical research. According to Green, their methods could be adapted for a number of different applications including ear and nose structures or even bone repair.
“The challenge before us now is to find a way to refine the technology, test it, and make it available for other children all over the world,” said Green.
Image credit: University of Michigan Health System