Novel 3D printed tracheostomy tube offers life-changing solution for pediatric patient

In a pioneering case that showcases the potential of patient-specific 3D printing in pediatric medicine, a multidisciplinary team at the Mayo Clinic has successfully developed and implemented a fully individualized 3D printed tracheostomy tube for a young patient suffering from recurrent, life-threatening tracheal erosion. The case, recently published in Otolaryngology Case Reports, marks the first documented instance of a 3D printed tracheostomy tube being used to address vertebral erosion caused by a conventional tracheostomy cannula.

The patient, a 14-year-old girl with a complex medical history including pontocerebellar hypoplasia type 1B, neuromuscular scoliosis, and long-standing tracheostomy dependence, presented with a rare and severe complication: full-thickness erosion of the posterior tracheal wall into the vertebral bodies. This condition was exacerbated by progressive loss of thoracic kyphosis and the narrowing of the anterior-posterior diameter of her thoracic inlet, which distorted the natural curvature of the trachea. Commercially available tracheostomy tubes were unable to accommodate this anatomy without exerting damaging pressure on the trachea, ultimately contributing to the erosion and raising alarm for potential vertebral osteomyelitis, a life-threatening complication.

Previously, the patient had undergone invasive thoracic surgeries, including manubriectomy and reimplantation of the innominate artery, which had temporarily resolved her symptoms. However, as her condition progressed and surgical options diminished, the care team pursued a novel route: the creation of a custom tracheostomy tube using 3D printing technologies.

Using a high-resolution CT scan of the patient’s thorax, engineers designed a tube that precisely followed the tortuous path of her trachea while avoiding the ulcerated areas. The device was printed in a dental-grade biocompatible resin—poly methacrylate—chosen for its durability, smooth finish, and suitability for sterilization. The tube was fabricated using FDA-cleared software and equipment typically employed for class II medical devices. The final design replicated the dimensions of the patient’s previous tracheostomy tube but featured an adjusted curvature to prevent pressure on the tracheal wall.

Following approval for compassionate use by the FDA and the Mayo Clinic’s IRB, the custom tube was placed during a bronchoscopy procedure. Unlike the standard tube, which had veered into the erosion site and contributed to granulation tissue formation, the 3D-printed tube aligned with the midline of the trachea and bypassed the ulcer entirely. Post-placement results were remarkable: the patient’s pain resolved, there were no signs of infection, and follow-up imaging revealed the regrowth of healthy tracheal tissue and proper anatomical alignment. Repeat bronchoscopy at eight weeks confirmed complete healing of the ulcer, with only minor granulation tissue remaining.

At nearly three years of follow-up, the tube remains in place without complications. Minor adjustments were made to address early issues, including a pressure ulcer at the stoma and difficulty threading ties through the tube’s eyelets. These were resolved by redesigning the flanges and enlarging the tie openings, improvements made quickly thanks to the flexibility of in-house 3D printing.

This case underscores the unique needs of pediatric patients with complex anatomical deformities and the limitations of off-the-shelf medical devices. In situations where anatomy deviates significantly from the norm—particularly in conditions like hypokyphotic scoliosis—custom solutions may not just be beneficial but essential. The authors emphasize the significant advantages of locally manufactured, patient-specific airway devices: rapid turnaround, cost-efficiency, and adaptability to anatomical changes over time.

While custom tracheostomy devices have previously been modeled and fabricated through third-party manufacturers, this marks the first instance of an entirely 3D-printed tracheostomy tube being used directly in a clinical setting. Its success opens the door for broader use of 3D printing in managing complex pediatric airway cases and signals a promising shift toward personalized medicine, especially in patient populations underserved by conventional device markets.

The study’s authors—Dr. Ibrahim Serhat Karakuş, Adam J. Wentworth, Dr. Jonathan M. Morris, and Dr. R. Paul Boesch—collectively represent expertise in pulmonology, biomedical engineering, and medical 3D printing. Together, they advocate for increased exploration of 3D-printed devices to meet the individualized needs of pediatric patients with anatomical challenges where traditional interventions fall short.