Development of a 3D bellows tracheal graft: Mechanical behavior analysis, fabrication and an in vivo feasibility study

Artificial tracheal grafts should have not only enough compressive strength to maintain an open tracheal lumen, but also sufficient flexibility for stable mechanical behavior, similar to the native trachea at the implant site. In this study, we developed a new 3D artificial tracheal graft using a bellows design for considering its mechanical behavior. To investigate the mechanical behavior of the bellows structure, finite element method (FEM) analysis in terms of longitudinal tension/compression, bending and radial compression was conducted. The bellows structure was then compared with the cylinder structure generally used for artificial tracheal grafts. The FEM analysis showed that the bellows had outstanding flexibility in longitudinal tension/compression and bending. Moreover, the bellows kept the lumen open without severe luminal deformation in comparison with the cylinder structure. A three-dimensional artificial tracheal graft with a bellows design was fabricated using indirect solid freeform fabrication technology, and the actual mechanical test was conducted to investigate the actual mechanical behavior of the bellows graft. The fabricated bellows graft was then applied to segmental tracheal reconstruction in a rabbit model to assess its applicability. The bellows graft was completely incorporated into newly regenerated connective tissue and no obstruction at the implanted site was observed for up to 8 weeks after implantation. The data suggested that the developed bellows tracheal graft could be a promising alternative for tracheal reconstruction.