Triple-layered polyurethane prosthesis with wrinkles for repairing partial tracheal defects.

OBJECTIVES/HYPOTHESIS The purpose of this study was to develop a triple-layered artificial polyurethane (PU) scaffold with a wrinkled layer for reconstruction of partial tracheal defects. STUDY DESIGN Animal experiment. METHODS PU/Pluronic F127 solution was transformed into an asymmetrically porous PU membrane by an immersion precipitation method. The nonporous wrinkled film was prepared by a simple casting of the PU solution on a grooved mold. The triple-layered wrinkled PU scaffolds were fabricated by simple inosculating between the wrinkled film and the porous membranes as in a sandwich (porous/wrinkled/porous structure). Scaffolds were transplanted into 10 New Zealand rabbits after creating tracheal windows. Endoscopic and histological examinations and mechanical tests were performed. RESULTS The thickness and outer pore size of the prepared triple-layered PU scaffold were ∼1.95 mm and ∼200 μm, respectively. The wrinkled PU scaffold showed better maximum flexural strength compared to the nonwrinkled scaffold (1.03 ± 0.19 vs. 0.56 ± 0.09 MPa). Eight of 10 rabbits survived through all of the examinations and procedures. Endoscopic findings revealed that respiratory mucosa was observed over the scaffold at 3 weeks, and it was an entirely covered scaffold at 6 weeks. The circular framework of the tracheal lumen was maintained in seven of 10 rabbits. Histologic findings showed that ciliated respiratory mucosa covered the surface of the scaffolds. The tensile strength of the scaffold-implanted trachea was lower than that of the normal control. CONCLUSIONS A wrinkled, triple-layered PU scaffold can be used as a ready-made scaffold for reconstruction of partial tracheal defects. LEVEL OF EVIDENCE NA.