Immersed multilayer biodegradable ureteral stent with reformed biodegradation: An in vitro experiment.

Objective: The aim of this study was to develop a novel immersed multilayer biodegradable ureteral stent with reformed biodegradation and evaluate it in vitro. Methods: Poly(glycolic-co-lactic acid) (PGLA), microsphere zein and BaSO4 were employed to produce a multilayer biodegradable stent using immersion technology. Tests of the biodegradable stents and conventional control stents were conducted in human urine in vitro to evaluate the biodegradable properties. The biocompatibility was assessed by the morphology and proliferation of urine-derived cells cultured with extracted media from the biodegradable stent and a latex material positive control. Results: An immersed multilayer biodegradable stent was successfully produced. It began to degrade in week 2 and was fully degraded by week 4. The mass loss ratio in the first 2 weeks was low (approximately 10.0% at 1 week, 20.0% at 2 weeks) and increased after 3 weeks (approximately 70%) to the end of testing. During the first 2 weeks, the radial compression load performances of the biodegradable stents were better than those of the control stents with statistically significant differences (p = 0.00, p = 0.01) and the tensile strengths were lower in the biodegradable stents than those in the control stents throughout the experiment. SEM showed that the stents degraded layer by layer from the outer to the inner wall. The influences on the cells of extracted medium from the biodegradable stents were morphologically slight and lower than 10% in relative growth rates. Conclusions: This preliminary study demonstrates that the immersed multilayer biodegradable ureteral stent has good radial compression and biocompatible performance and can be degraded in vitro within 4 weeks in a moderate manner.