辐射灭菌超高分子量聚乙烯氧化水平变化[医用植入材料应用]

S. Phillips, A. Puckett, A. McKie
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摘要

摘要:本研究的目的是监测辐射灭菌超高分子量聚乙烯(UHMWPE)氧化水平随时间的变化。超高分子量聚乙烯标本在空气中包装,并使用商业循环在2.5兆加仑或3.7兆加仑灭菌。同一批次未灭菌材料的对照标本在同一时间段内进行监测。每个样品在收到后切片,产生三个100 /spl mu/m厚的样品,使用傅里叶变换红外(FTIR)显微镜进行表征。采用游标平台和可调狭缝孔径,以100 /spl μ m的增量采集光谱。在两种辐射水平下,初始表面氧化水平都比对照样品高300%。储存12个月后,准备并检查额外的样品。样品在空气中辐照3.7兆加仑时,表面氧化增加500%,向材料中扩展200 /spl μ l /m。在2.5 μ g辐照下,样品表面氧化水平增加了300%,而在200 μ g / m2辐照下,氧化水平仅增加了170%。这些结果表明,辐射灭菌的超高分子量聚乙烯在储存过程中会显著增加。辐射灭菌的超高分子量聚乙烯植入物的氧化可能对这些材料的承载性能产生重大影响。
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Oxidation level changes in radiation sterilized ultra high molecular weight polyethylene [medical implant material application]
Summary form only received as follows: The objective of this study was to monitor the change in oxidation levels of radiation sterilized ultra high molecular weight polyethylene (UHMWPE) with time. Specimens of UHMWPE were packaged in air and sterilized at 2.5 megarads or 3.7 megarads using a commercial cycle. Control specimens from the same lot of material which were not sterilized were monitored over the same time period. Each sample was sectioned upon receipt to produce three 100 /spl mu/m thick specimens which were characterized using Fourier transform infrared (FTIR) microscopy. Spectra were collected at 100 /spl mu/m increments using a vernier stage and adjustable slit aperture. The initial surface oxidation levels were 300% greater than control samples for both radiation levels. After 12 months of storage, additional samples were prepared and examined. Samples irradiated at 3.7 megarads in air showed an additional 500% increase in surface oxidation which extended 200 /spl mu/m into the material. For the sample irradiated at 2.5 megarads a 300% additional increase in oxidation level was found on the surface but the oxidation level was only 170% greater at 200 /spl mu/m. These results suggest that radiation sterilized UHMWPE undergoes significant increases during storage. Oxidation of radiation sterilized UHMWPE implants may have a significant impact on the bearing properties of these materials.
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