Biocompatibility of alumina ceramic and polyethylene as materials for pivot bearings of a centrifugal blood pump

Abstract

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.

The Genotoxic Potential of Novel Materials Used in Modern Hip Replacements for Young Patients

“…Alumina's biocompatibility has been evaluated by Takami et al using the Ames test in bacteria; no mutagenic activity was observed in 5 tester strains of Salmonella typhimurium. In addition, no cytotoxicity was observed in mouse fibroblast cells following incubation with Al 2 O 3 disks in cultures for up to 48 hours (Takami et al, 1997).…”

Development of a New Zirconia-Toughened Alumina: Promising Mechanical Properties and Absence of In Vitro Carcinogenicity

“…Zirconia ceramics have been considered potentially carcinogenic due to the possible radioactivity ofthe precursors. (13)(14), and did not induce tumours after long-term implantation in rabbits (15). A review on zirconia radioactivity and its possible carcinogenic potential reported that the radioactivity of the powder depends on the source of ores used in the production ofthe chemical precursor of the zirconia (16)(17).…”

Commodity Thermoplastics

“…However, oxidation of the surface during radiation sterilization can affect the biocompatibility [64], so sterilization should be conducted in an inert atmosphere in order to maintain the inertness of the surface. The material was evaluated using system toxicity, sensitization, cytotoxicity, mutagenicity, and direct contact hemolysis and thrombogenicity tests [65]. The material was evaluated using system toxicity, sensitization, cytotoxicity, mutagenicity, and direct contact hemolysis and thrombogenicity tests [65].…”