Takami Y, Nakazawa T, Makinouchi K, Glueck J, Nosé Y
Department of Surgery, Baylor College of Medicine, Houston, Texas 77030, USA.
J Biomed Mater Res. 1997 Sep 5;36(3):381-6. doi: 10.1002/(sici)1097-4636(19970905)36:3<381::aid-jbm12>3.0.co;2-h.
The double pivot bearings in the Gyro C1E3 centrifugal blood pump incorporate a high-purity alumina (Al2O3) ceramic and an ultra-high-molecular-weight polyethylene (UHMWPE). This centrifugal pump has been developed as a completely sealless pump for long-term usage. The combination of Al2O3 and UHMWPE are the materials of choice for the acetabular bearing in artificial joints, which have proven to be clinically reliable for over 10 years. Previous studies have examined the biocompatibility of Al2O3 and UHMWPE as bulky implant materials. The present study investigated this material as a blood-contacting material using a standard assessment in vitro and in vivo analysis. The examined items were systemic toxicity, sensitization (guinea pig maximization test), cytotoxicity (elution test), mutagenicity (Ames test), direct contact hemolysis, and thrombogenicity. The studies were performed according to the United States Pharmacopoeia and published previous studies. The samples of both Al2O3 and UHMWPE demonstrated no differences from the negative controls in all tests. These findings indicate that both Al2O3 and UHMWPE are biocompatible materials for double-pivot bearings in the centrifugal blood pump.
陀螺C1E3离心式血泵中的双枢轴轴承采用了高纯度氧化铝（Al2O3）陶瓷和超高分子量聚乙烯（UHMWPE）。这种离心泵已被开发为一种完全无密封的长期使用泵。Al2O3和UHMWPE的组合是人工关节髋臼轴承的首选材料，在临床上已被证明可靠超过10年。以往的研究考察了Al2O3和UHMWPE作为大块植入材料的生物相容性。本研究使用标准的体外评估和体内分析来研究这种材料作为血液接触材料的情况。检查的项目包括全身毒性、致敏性（豚鼠最大化试验）、细胞毒性（洗脱试验）、致突变性（艾姆斯试验）、直接接触溶血和血栓形成性。这些研究是根据美国药典和先前发表的研究进行的。Al2O3和UHMWPE的样品在所有测试中均与阴性对照无差异。这些发现表明，Al2O3和UHMWPE都是离心式血泵双枢轴轴承的生物相容性材料。
