A novel biodegradable esophageal stent: results from mechanical and animal experiments.

Biodegradable esophageal stents eliminate stent retrieval, but usually induce hyperplasia. This study investigated the properties of a novel biodegradable stent in vitro and in vivo. The degradation of the novel stent was observed in phosphate buffered saline (PBS) for 8 weeks. The radial forces, pH values, morphology, and retention rate of the intrinsic viscosity (R[η]) of the new biodegradable stent were all evaluated. In vitro, the pH values remained constant for 4 weeks and declined from weeks 4 to 8. The biodegradable threads degraded and ruptured at 6 weeks. Consequently, the radial force of the stent decreased to zero at that time. The curve of R[η] decreased with time linearly in PBS. To study the stents in vivo, we used a stricture model in which the middle esophagus of rabbits was damaged by alkali burn. Stents were inserted 2 weeks after injury and observed for 8 weeks. We assessed complications related to stent insertion, degradation of the stent, and survival of the rabbits. Two stents migrated, and one rabbit died. In the other rabbits, two stents degraded and moved into the stomach during the sixth week, five during the seventh week and one during the eighth week, respectively. One stent remained in position until the end of the study. In conclusion, our newly designed stent retained the strong radial force of self-expandable metal stents (SEMSs) and maintained the biodegradable properties of biodegradable (BD) stents.