In vivo assessment of a novel biodegradable ureteral stent

Abstract

Purpose: To perform an in vivo assessment of a newly developed biodegradable ureteral stent (BUS) produced with natural-based polymers. Methods: The BUS is based on a patented technology combining the injection process with the use of supercritical fluid technology. The study was conducted at ICVS-University of Minho (Braga, Portugal) and a total of ten domestic pigs were used. In seven animals, the experimental BUS stent was inserted, whereas in the remaining a commercially available stent was used (6-Fr Biosoft(®) duo stents, Porges Coloplast, Denmark). Post-stenting intravenous pyelogram was used to evaluate the degree of hydronephrosis. The in vivo stent degradation was measured as a function of the weight loss. Moreover, the tensile properties of the BUS were tested during in vivo degradation. After maximum 10 days, animals were killed and necropsy was performed. Tissues were compared between the stented groups as well as between the non-stented contralateral ureters and stented ureters in each group. Biocompatibility was assessed by histopathological grading. Results: In all cases, the BUS was only visible during the first 24 h on X-ray, and in all cases, the BUS was completely degraded in urine after 10 days, as confirmed on necropsy. During the degradation process, the mechanical properties of the BUS decreased, while the commercial ureteral stents remained constant. At all time-points after stent insertion, the level of hydronephrosis was minimal. Overall, animals stented with BUS had an average grade of hydronephrosis which was lower compared to the controls. The BUS showed better pathological conditions, and hence better biocompatibility when compared with commercial stents. Conclusions: Notwithstanding the limitations of the present study, the in vivo testing of our novel natural origin polymer-based BUS suggests this device to feature homogeneous degradation, good urine drainage, and high biocompatibility. Next steps will be to increase its stability and to improve the radiopacity without compromising its degradation. Ultimately, clinical studies will be required to determine the safety and feasibility of its use in humans.