Abstract
Severe infantile tracheobronchomalacia (TBM) is often treated with invasive surgery and fixed-size implants to support the trachea during respiration. A novel 3D-printed extra-luminal splint has been developed as a flexible and bioresorbable alternative. Therefore, the goal of the present study was to use an in vitro breathing simulator model to comprehensively evaluate the structural stiffness and failure modes of two sizes of a novel bioresorbable 3D-printed splint design under a range of physiological degradation conditions. Two thicknesses, 2 mm and 3 mm, of a novel 3D-printed bioresorbable splint were evaluated under two different degradation conditions, phosphate-buffered saline (PBS) and sodium hydroxide (NaOH). The splints were subjected to simulated breathing loading, involving a cyclic opening and closing of the splint by 2 mm, for a targeted duration of 7.5 to 30 million cycles. A separate new set of splints were statically soaked in their respective degradation condition for a comparative analysis of the effects of cyclic loading by the degradation medium. After successfully simulated breathing or static soaking, non-destructive tensile and compressive strengths were evaluated, and overall stiffness was calculated from destructive tensile testing. The present study indicates that the splints were more significantly degraded under simulated breathing conditions than under soaking. Cyclic simulated breathing specimens failed far earlier than the intended duration of loading. Over time, both 2 mm and 3 mm splints became increasingly more flexible when subjected to the static degradation conditions. Interestingly, there was little difference in the compressive and tensile strengths of the 2 mm and 3 mm thickness splints. The bioresorbable nature of PCL offers a valuable advantage as it eliminates the need for splint removal surgery and increases device flexibility over time with degradation. This increased flexibility is crucial because it allows for uninhibited growth and development of the infant's trachea over the intended use period of 2 years. The results of this study confirm that the splints were able to withstand tensile forces to prevent tracheal collapse. This study further supports the successful use of 3D-printed splints in the treatment of infantile TBM.