热固性乙烯基酯树脂基碳纤维复合材料骨内固定物的生物安全性研究

Biocompatible study on orthopedic internal fixation with thermosetting vinylesterresin-based carbon fiber composite materials

目的对自制的碳纤维复合树脂材料进行生物安全性评价,为其临床应用的安全性提供实验依据。方法参照国内外医用高分子材料生物学评价实验方法,对该材料进行了有关生物相容性的检测试验。结果该碳纤维复合材料对机体无毒性,对组织、皮肤无刺激性,无溶血,对皮肤无致敏性,无致突变性,植入皮肤及组织内反应很小。结论该碳纤维复合材料是一种对机体无毒性和不良反应的理想的生物材料,其性能已经达到临床要求。

Objective To observe biocompatibility of orthopedic internal fixation with carbon fiber reinforced resin,in order to evaluate the safety for patients and provide scientific evidence for clinical use.Methods The biocompatibility study of orthopedic internal fixation with carbon fiber reinforced resin was refered to domestic and abroad experimental methods of biological evaluation of medical polymer materials.Results The biocompatibility of orthopedic internal fixation with carbon fiber reinforced resin was satisfactory.It had no toxicity and side-effects eg.hemolysis and hypotension.It had no carcinogenicity andreactogenicity in tissues and skin.Conclusions The carbon fiber reinforced resin was a kind of satisfactory replacement material for orthopedic internal fixation for the standard in clinical use.