Arsenal Medical, Inc., 480 Arsenal Street, Watertown, MA 02472, USA.
Biomaterials. 2010 Nov;31(31):7847-55. doi: 10.1016/j.biomaterials.2010.06.057. Epub 2010 Aug 8.
The goal of this study was to evaluate the biocompatibility of materials for use in fully bioabsorbable vascular stents. 10:90 poly(L-lactic-co-glycolic acid) (10:90 L-PLGA), 85:15 poly(L-lactic-co-glycolic acid) (85:15 L-PLGA), polydioxanone (PDO), and poly-L-lactic acid (L-PLA) polymers were chosen as materials. Polymeric fibers were woven into a braided structure with a mass equivalent to or greater than that expected for a vascular stent, secured to balloon-expandable bare metal stents and implanted into porcine carotid arteries. The in vivo response was analyzed at 30 and 90 days by angiography, histopathology, and histomorphometry. All vessels were patent at 30 and 90 days. Injury score and neointima formation was mild for all samples. The faster-degrading 10:90 L-PLGA had the highest inflammatory response at 30 days, but was completely absorbed with minimal inflammation and neointimal formation at 90 days. PDO showed signs of partial absorption at 90 days, while 85:15 L-PLGA and L-PLA demonstrated minimal absorption at 30 and 90 days. The inflammatory response to these three groups was similar over the experimental period. Using a robust materials-testing platform, we demonstrated long-term patency and intravascular biocompatibility of bioabsorbable polymers with varying rates of resorption. The data point to biocompatibility of a polymeric stent in the vascular space that is fully absorbable in less than a year.
本研究的目的是评估完全可生物吸收血管支架用材料的生物相容性。选择了 10:90 聚(L-丙交酯-co-乙交酯)(10:90 L-PLGA)、85:15 聚(L-丙交酯-co-乙交酯)(85:15 L-PLGA)、聚二氧杂环己酮(PDO)和聚 L-乳酸(L-PLA)聚合物作为材料。将聚合物纤维编织成与血管支架预期质量相等或更大的编织结构,固定在球囊扩张的裸金属支架上,并植入猪颈动脉。通过血管造影、组织病理学和组织形态计量学在 30 天和 90 天分析体内反应。所有血管在 30 天和 90 天都保持通畅。所有样本的损伤评分和新生内膜形成均较轻。降解速度较快的 10:90 L-PLGA 在 30 天时表现出最高的炎症反应,但在 90 天时完全吸收,炎症和新生内膜形成最小。PDO 在 90 天时出现部分吸收迹象,而 85:15 L-PLGA 和 L-PLA 在 30 天和 90 天时吸收较少。这三组在整个实验期间的炎症反应相似。使用强大的材料测试平台,我们证明了具有不同吸收率的可生物吸收聚合物具有长期通畅性和血管内生物相容性。数据表明,在不到一年的时间内,血管内完全可吸收的聚合物支架具有生物相容性。