Polydioxanone (PPDX), as an FDA approved polymer in tissue engineering, is an important component of some promising medical devices, e.g., biodegradable stents. The hydrolytic degradation of polydioxanone stents plays a key role in the safety and efficacy of treatment. A new fast and convenient method to quantitatively evaluate the hydrolytic degradation of PPDX stent material was developed. PPDX esophageal stents were degraded in phosphate-buffered saline for 24 weeks. For the first time, the changes in Raman spectra during PPDX biodegradation have been investigated here. The level of PPDX hydrolytic degradation was determined from the Raman spectra by calculating the area under the 1732 cm-1 peak shoulder. Raman spectroscopy, unlike Fourier transform infrared (FT-IR) spectroscopy, is also sensitive enough to monitor the decrease in the dye content in the stents during the degradation. Observation by a scanning electron microscope showed gradually growing cracks, eventually leading to the stent disintegration. The material crystallinity was increasing during the first 16 weeks, suggesting preferential degradation of the amorphous phase. Our results show a new easy and reliable way to evaluate the progression of PPDX hydrolytic degradation. The proposed approach can be useful for further studies on the behavior of PPDX materials, and for clinical practice.

Department of Biology University of Hradec Králové Rokitanského 62 500 03 Hradec Králové Czech Republic

Department of Chemistry University of Hradec Králové Rokitanského 62 500 03 Hradec Králové Czech Republic

Department of Medical Biophysics Faculty of Medicine in Hradec Králové Charles University 500 03 Hradec Králové Czech Republic

Department of Physics University of Hradec Králové Rokitanského 62 500 03 Hradec Králové Czech Republic

ELLA CS s r o Milady Horákové 504 45 500 06 Hradec Králové Czech Republic

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A Complex In Vitro Degradation Study on Polydioxanone Biliary Stents during a Clinically Relevant Period with the Focus on Raman Spectroscopy Validation