Cardiovascular stents are currently being used for intraluminal stenting of the trachea for tracheomalacia treatment. These devices composed of permanent materials are controversial due to their limitations at internal reinforcement and biocompatibility, especially in pediatrics. We show in a pediatric tracheomalacia rabbit model, a poly-L-lactic acid (PLLA) Double Opposed Helical bioresorbable stent (DH) elicits a more mild inflammatory response in the malacic airway compared to a control metal stent. To further improve efficacy, a multi-drug delivery, bioresorbable coating was designed. The coating design controllably delivers ciprofloxacin (antibiotic) for one week and dexamethasone (anti-inflammatory agent) for three months. The bioresorbable polymeric components also demonstrate feasible visibility utilizing Magnetic Resonance Imaging (MRI). The local multi-drug delivery and imaging capabilities in this coating design in combination with the bioresorbable DH stent will result in a successful intervention specifically design for pediatric tracheomalacia. This design will eliminate long-term risks associated with current permanent devices and provide necessary theranostic agents to facilitate healing and monitor progress via non-invasive imaging techniques.

Bioresorbable stents with limited functional lifetimes and with drug delivery capabilities are desired. Various methods have been investigated to induce porosity in bioresorbable polymeric stent fibers, thereby to permit increased drug reservoir capacity versus polymer-coated metal stents. We developed microporous surface layers on PLLA fibers to serve as the drug reservoir, but found that impurities, the use of chemicals, and multiple step procedures associated with our, and other published methods limited utility. Thus we investigated theoretically attractive CO 2 blowing methods, in which gas under pressure and temperature induces porosity. We report the results of initial studies of CO 2 -induced porosity in PLLA stent fibers.