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3D printed tracheal splints are shown around a model of a patient’s trachea. The splints are designed to be absorbed into the body, allowing for expansion of the trachea and bronchus. (Credit: Rob Felt, Georgia Tech)

Children’s Healthcare of Atlanta has performed Georgia’s first-ever procedure to place 3D-printed tracheal splints in a pediatric patient. Biomedical engineers at the Georgia Institute of Technology helped create three custom splints using an innovative and experimental 3D printing technology.

Scott Hollister, PhD, developed the process for creating the tracheal splint using 3D printing technology at University of Michigan C.S. Mott Children’s Hospital prior to joining Georgia Tech.The splints were created using reconstructions of the patient’s air ways from CT scans. Hollister and his team of biomedical engineers collaborated with the Global Center for Medical Innovation (GCMI) so that GCMI could create multiple versions of the splint, of varying sizes, to ensure the perfect fit was available for the surgical team to select and place around the patient’s airways during surgery. GCMI will also support the ongoing development and commercialization of the technology.

A cross-functional team of Children’s surgeons used the custom-made splints to assist the breathing of a 7-month-old patient battling life-threatening airway obstruction. The 7-month-old patient who received the surgery is battling both congenital heart disease and tracheo-bronchomalacia, a condition that causes severe life-threatening airway obstruction. During his six-month inpatient stay in the Pediatric Intensive Care Unit at Children’s, he experienced frequent episodes of airway collapse that could not be corrected by typical surgery protocols. The clinical team proposed surgically inserting an experimental 3D-printed tracheal splint, which is a novel device still in development, to open his airways and expand the trachea and bronchus.

In a complex 10-hour surgery, Children’s cross-functional team of surgeons successfully placed three 3D-printed splints around the patient’s trachea on the morning of August 17, 2018. The splints will eventually be absorbed into the body, allowing for expansion of the trachea and bronchus.

The Children’s tracheal splint team included Steve Goudy, M.D., and April Landry, M.D., (ENT), pediatric otolaryngologists; Subhadra Shashidharan, M.D., pediatric cardiothoracic surgeon; and Kevin Maher, M.D., pediatric cardiologist.

As the tracheal procedure concluded, the child was placed on a heart lung machine for surgical repair of his cardiac defect. Postoperative care took place in the Cardiac ICU and the Pediatric ICU at Children’s.

The 3D-printed tracheal splint is a new device still under development, as safety and effectiveness have not yet been determined and is therefore not available for clinical use. The Children’s team sought emergency clearance from the FDA to move forward with the procedure under expanded access guidelines.

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