Early preclinical evaluation of a novel, computer aided designed, 3D printed, bioresorbable posterior cricoid scaffold

Objectives: The posterior cricoid split with rib graft is a procedure that elegantly corrects pediatric posterior glottic stenosis and subglottic stenosis. Currently, the procedure requires harvesting of rib cartilage which leaves room for optimization. With use of three dimensional printing technology, our objective was to design a device that would negate the need for costal cartilage harvesting in this procedure. Methods: An optimized, novel polycaprolactone scaffold was designed using computer aided design software and three dimensional printing. A pilot proof of concept study was conducted with implantation of the device in three porcine animal subjects. Device was evaluated by post-procedural clinical course, endoscopic exams, post -mortem exam, and histological evaluation. Results: A series of variably sized scaffolds were created. The scaffolds showed structural integrity and suc-cessfully expanded the cricoid cartilage in the porcine model study. Post-operative endoscopy and clinical exams demonstrated no signs of implant instability or failure. Gross and histologic exams showed successful mucos-alization over the scaffold and cartilage ingrowth by six weeks. Conclusion: This porcine animal pilot study demonstrated early success of a computer-aided designed, 3D printed, bioresorbable PCL posterior graft scaffold. The scaffolds eliminate the need for costal cartilage harvesting and had excellent surgical usability. The scaffolds functioned as designed, offering proof of concept and grounds for further evaluation to expand on this small pilot study with larger animal studies and continued design refinement.