Isotalo T, Halasz A, Talja M, Tammela T L, Paasimaa S, Törmälä P
Division of Urology, Tampere University Hospital, Lahti, Finland.
J Endourol. 1999 Sep;13(7):525-30. doi: 10.1089/end.1999.13.525.
The bioabsorption time as well as other properties of bioabsorbable polymers can be affected by the choice of the basic molecule, by the degree of its polymerization, and by the coating material used in the device. The aim of our present study was to evaluate the biocompatibility of a new caprolactone copolymer-coated, self-reinforced poly-L-lactic acid (SR-PLLA) urethral stent by means of a rabbit muscle implantation test. This new material has previously been tested for cytotoxicity using the thymidine incorporation method (DNA synthesis inhibition test), no toxicity being evidenced.
Fifteen male rabbits were used as experimental animals. Rods made from pure lactic acid, pure caprolactone copolymer, and caprolactone-coated lactic acid were placed on both sides of the dorsal muscles, eight implants per rabbit. Rods made from latex and silicone were used as positive and negative controls, respectively. The animals were sacrificed after 1 week, 1 month, or 6 months. Tissue reactions around the implants were analyzed and scored semiquantitatively.
Acute tissue reactions attributable to operative trauma were seen in all specimens at 1 week. After 6 months, chronic inflammatory changes and foreign-body reactions were seen only in the positive controls.
The new caprolactone copolymer material is highly biocompatible.
生物可吸收聚合物的生物吸收时间以及其他特性会受到基本分子的选择、其聚合度以及器械中使用的涂层材料的影响。我们当前研究的目的是通过兔肌肉植入试验来评估一种新型己内酯共聚物涂层的自增强聚-L-乳酸（SR-PLLA）尿道支架的生物相容性。这种新材料此前已通过胸腺嘧啶核苷掺入法（DNA合成抑制试验）进行了细胞毒性测试，未发现毒性。
15只雄性兔子用作实验动物。将由纯乳酸、纯己内酯共聚物以及己内酯涂层乳酸制成的棒材放置在背部肌肉两侧，每只兔子植入8根。由乳胶和硅酮制成的棒材分别用作阳性和阴性对照。在1周、1个月或6个月后处死动物。对植入物周围的组织反应进行分析并进行半定量评分。
在1周时，所有标本中均可见到归因于手术创伤的急性组织反应。6个月后，仅在阳性对照中观察到慢性炎症变化和异物反应。
新型己内酯共聚物材料具有高度生物相容性。
