World’s First Customized 3D Printed Airway Stents Developed and Implemented in France

Not all 3D printing in the medical field means that someone’s managed to 3D print skin, kidneys, or other organs. Oftentimes, 3D printing technology is used in the creation of medical tools and instruments, patient-specific models, surgical guides, and stents. Stents are basically small, expandable tubes used to keep passageways, like blood vessels, arteries, or airways open. Last year, Northwestern University used 3D printing to develop patient-specific vascular stents, and a cardiologist at the Heart Institute Children’s Hospital Los Angeles was able to create a custom pediatric stent by using a 3D printed model of the patient’s heart. But now, researchers in France have broken some new ground. The team was built through a collaboration between Toulouse-based startup AnatomikModeling and the Pulmonology department at Toulouse University Hospital. They’ve successfully developed, and implanted, a number of custom stents that have identical anatomies to the trachea and/or bronchi of their patients, and they say it’s the world’s first 3D customized airway stent ever created.

These made to measure stents give patients who can’t wear standard prostheses hope that they can soon, literally, breathe easy. Stenosis, which means narrowing, of the bronchi and/or trachea, can cause patients to suffer difficulty breathing, and can only be managed by implanting a stent in the patient’s airway. Any number of things can cause stenosis, including tracheal tissue disease, post-lung transplantation complications, anatomical tracheal idiosyncrasies, and post-intubation and post-tracheotomy problems. In addition, patients with lung cancer often suffer from upper airway obstructions. Implanting a patient-specific tracheobronchial prosthesis can be life-changing for patients suffering trachea/bronchi stenosis.

3D custom made airway stent [Image: AnatomikModeling]

AnatomikModeling was established in 2015, after a decade of collaboration with Toulouse University Hospital working on 3D modeling techniques and advanced reconstructive surgery. The startup develops customized medical devices for maxillofacial surgery, thoracic surgery, and reconstructive surgery, focusing specifically on solutions for muscle deficiency (atrophy of the calf muscle), Poland syndrome (total or partial absence of the pectoralis muscle, and Pectus Excavatum (funnel chest).

The first results from a clinical trial that the startup completed with Toulouse University Hospital were recently published in a paper, titled “Treatment of Post-transplant Complex Airway Stenosis with a Three-dimensional, Computer-assisted Customized Airway Stent,” in the American Journal of Respiratory and Critical Care Medicine. Co-authors of the paper include Laurent Brouchet MD, PhD; Alain Didier; Nicolas Guibert; Christophe Hermant; Julien Mazieres; Laurent Mhanna; Benjamin Moreno, PhD; and Gavin Plat.

To make the new prostheses, researchers take CT scan images of the patient’s airways, and create a virtual 3D reconstruction, which is then used to make a mold. The patient-specific prosthesis is made using medical grade silicone elastomer. Using a prosthesis pusher, the prosthesis is implanted during a conventional bronchoscopy, while the patient is under general anesthesia.  The stent’s rigidity can also be calculated, as a function of the stenosis of the bronchi and/or trachea.

The technology is currently being evaluated in an an ongoing clinical trial, and the initial results are pretty promising. Several patients who have successfully received these new implants are reporting no complications yet, and a “markedly improved quality of life.” Discuss in the 3D Printed Stent forum at 3DPB.com.