First patient-specific 3D-printed trachea implanted in humans

University Hospital (UH) medical staff recently inserted the first patient-specific 3D-printed T-tube into a human patient. The patient was suffering from complications with his standard T-tube. The FDA approved the use under compassionate use.

Sterling Brown, a patient who had undergone a tracheostomy due to life-threatening complications from obesity and hypertension, suffered from the side effects of a standard T-tube.

“Sterling has a very uniquely shaped airway,” said Dr. Scott Howard, otolaryngologist and Director of the Voice, Airway and Swallowing Center at UH Cleveland Medical Center. “The commercially available T-tube wasn’t a good fit for him despite attempts to modify it and was causing complications including infections and damage to his vocal cords.”

Although the FDA has not yet approved patient-specific 3D-printed T-tubes, similar patient-specific Y-stents for the lower airway have been approved. Dr. Benjamin Young, medical director of bronchoscopy at UH Cleveland Medical Center, said: “We’ve had success using the custom airway Y-stents in several of our patients. When it became apparent Sterling’s T-tube was causing so much trouble for him, we believed a custom device might help if we could make it happen.”

Dr. Howard erhielt die Genehmigung zur Anwendung aus humanitären Gründen und arbeitete mit VisionAir Solutions zusammen, einem in Cleveland ansässigen Unternehmen, das auf patientenspezifische Silikon-Atemwegsstents spezialisiert ist. Die Software des Unternehmens nutzt CT-Scans zur Erstellung eines 3D-Modells der Atemwege. Howard und Young passten das Design der T-Röhre genau an die Dimensionen von Browns Atemwegen an. Die patientenspezifische T-Röhre wurde am 26. Juni 2024 eingesetzt und zeigte schnell positive Ergebnisse.

“After the surgery to place this T-tube which was made for me, I had fewer complications,” said Brown. “The fit is improved and it creates less mucus. I’m talking better and the tube is no longer damaging my vocal cords.”

Traditional T-tubes need to be replaced regularly. Brown’s patient-specific version also needs to be changed, but at longer intervals, which means fewer procedures and hospital stays.

“I’m grateful to my medical team for not giving up. I’ve been sick for a long time,” he said. “I have hope to live a normal life again and find joy in singing thanks to the determination of my doctors.”

Brown is currently in a care facility and receiving therapy. If his recovery continues to progress, the T-tube could eventually be removed, allowing him to breathe, speak and sing normally again.