Biomaterials Lab, Department of Mechanical Engineering, Chang Gung University, 259, Wen-Hwa 1st Road, Kwei-San, Tao-Yuan 333, Taiwan.
Ann Biomed Eng. 2010 Oct;38(10):3185-94. doi: 10.1007/s10439-010-0075-6. Epub 2010 May 22.
The purpose of this report was to develop novel balloon-expandable self-lock drug-eluting poly(ε-caprolactone) stents. To fabricate the biodegradable stents, polycaprolactone (PCL) components were first fabricated by a lab-scale micro-injection molded machine. They were then assembled and hot-spot welded into mesh-like stents of 3 and 5 mm in diameters. A special geometry of the components was designed to self-lock the assembled stents and to resist the external pressure of the blood vessels after being expanded by balloons. Characterization of the biodegradable PCL stents was carried out. PCL stents exhibited comparable mechanical property to that of metallic stents. No significant collapse pressure reduction and weight loss of the stents were observed after being submerged in PBS for 12 weeks. In addition, the developed stent was coated with paclitaxel by a spray coating technique and the release characteristic of the drug was determined by an in vitro elution method. The high-performance liquid chromatography analysis showed that the biodegradable stents could release a high concentration of paclitaxel for more than 60 days. By adopting the novel techniques, we will be able to fabricate biodegradable drug-eluting PCL stents of different sizes for various cardiovascular applications.
本报告旨在开发新型球囊扩张自锁定载药聚己内酯（PCL）支架。为了制备可生物降解支架，首先通过实验室规模的微注塑机制造聚己内酯（PCL）组件。然后，将它们组装并热熔焊接成直径为 3 和 5 毫米的网状支架。组件的特殊几何形状旨在自锁定组装好的支架，并在通过球囊扩张后抵抗血管的外部压力。对可生物降解的 PCL 支架进行了特性分析。PCL 支架表现出与金属支架相当的机械性能。支架在 PBS 中浸泡 12 周后，没有观察到明显的坍塌压力降低和重量损失。此外，通过喷涂技术将紫杉醇涂覆在开发的支架上，并通过体外洗脱方法确定药物的释放特性。高效液相色谱分析表明，可生物降解的支架能够在 60 天以上的时间内释放出高浓度的紫杉醇。通过采用新技术，我们将能够为各种心血管应用制造不同尺寸的可生物降解载药 PCL 支架。
