Balloon-expandable trilayer nitrided iron/Zn/poly-D,L-lactic acid metallic tracheal stent: structural characterization, mechanical performance, and short-term safety evaluation in rabbits
Abstract
Background: Pediatric airway stenosis and tracheomalacia may require airway stenting to maintain patency. However, conventional metallic or silicone airway stents are associated with frequent complications such as granulation, mucus plugging, and migration. Although bioresorbable polymer stents reduce long-term indwelling, degradation fragments may still pose a risk of airway obstruction. Therefore, a tracheal stent designed to provide reliable early mechanical support, favorable tissue compatibility, and potential long-term bioresorption remains needed. This study aims to develop and evaluate a biodegradable tracheal stent with improved mechanical performance and biocompatibility.
Methods: A balloon-expandable trilayer tracheal stent was fabricated with a load-bearing nitrided iron (Fe-N) framework, a zinc (Zn) buffering layer, and an outer poly-D,L-lactic acid (PDLLA) coating. The layered structure and composition were verified by scanning electron microscopy (SEM), energy-dispersive spectroscopy (EDS), X-ray photoelectron spectroscopy (XPS), X-ray diffraction (XRD), and Fourier-transform infrared spectroscopy (FTIR). Radial compression testing was performed and compared with a pure iron stent of the same geometry. Stent extracts were prepared to evaluate in vitro biocompatibility using BEAS-2B cells, including scratch assay, 5-ethynyl-2'-deoxyuridine (EdU) assay, Transwell assay, terminal deoxynucleotidyl transferase dUTP nick-end labeling (TUNEL), cytoskeleton staining,…
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