Yang Ganggang, Xie Hua, Huang Yichen, Lv Yiqing, Zhang Mingqing, Shang Yafeng, Zhou Junmei, Wang Liping, Wang Jin-Ye, Chen Fang
1 Department of Urology, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.
2 School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.
J Biomater Appl. 2017 Mar;31(8):1235-1244. doi: 10.1177/0885328217692279.
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 BaSO 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.
目的 本研究旨在开发一种具有改良生物降解性能的新型浸没式多层可生物降解输尿管支架，并在体外对其进行评估。方法 采用聚（乙醇酸 - 乳酸）（PGLA）、玉米醇溶蛋白微球和硫酸钡，利用浸没技术制备多层可生物降解支架。在体外人尿液中对可生物降解支架和传统对照支架进行测试，以评估其生物降解性能。通过用从可生物降解支架和乳胶材料阳性对照中提取的培养基培养的尿液来源细胞的形态和增殖来评估生物相容性。结果 成功制备了浸没式多层可生物降解支架。它在第2周开始降解，并在第4周完全降解。前2周的质量损失率较低（第1周约为10.0%，第2周约为20.0%），3周后增加（约70%）直至测试结束。在前2周，可生物降解支架的径向压缩载荷性能优于对照支架，差异具有统计学意义（p = 0.00，p = 0.01），并且在整个实验过程中，可生物降解支架的拉伸强度低于对照支架。扫描电子显微镜显示，支架从外壁到内壁逐层降解。可生物降解支架提取培养基对细胞的影响在形态上轻微，相对生长率低于10%。结论 这项初步研究表明，浸没式多层可生物降解输尿管支架具有良好的径向压缩和生物相容性性能，并且可以在4周内在体外以适度的方式降解。
