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[关于技术和灭菌对全关节置换中UHMWPE的结构、性能及使用寿命影响的当前认知]

[Current knowledge on the effect of technology and sterilization on the structure, properties and longevity of UHMWPE in total joint replacement].

作者信息

Pokorný D, Šlouf M, Fulín P

机构信息

I. Ortopedická klinika 1. LF UK Praha, FN Motol, Praha.

出版信息

Acta Chir Orthop Traumatol Cech. 2012;79(3):213-21.

Abstract

Ultrahigh molecular weight polyethylene (UHMWPE) is the most frequently used bearing surface in currently used total joint replacements (TJR). According to the literature available, UHMWPE is the best polymer material, in terms of biocompatibility, mechanical properties and wear resistance, for this application. In spite of this fact, UHMWPE wear (i.e., release of microscopic particles from the polymer surface) remains one of the main reasons of TJR failures. Consequently, the wear of UHMWPE is a subject of intensive study by both materials scientists and orthopaedic surgeons. The structure and properties of UHMWPE strongly depend on the way of processing and post-processing modifications. The processing includes polymer resin preparation (microparticles about 100 ěm in size) and resin consolidation (forming bulk material). Post-processing modifications aim at increasing wear resistance and oxidation stability which are regarded as major factors involved in TJR failure. In order to maintain high purity materials for medical application, it is not allowed to use additional chemicals during the modification processes. The only exception is the use of vitamin E, a natural stabilizer and antioxidant. Considering all the above mentioned facts, the modifications can be based on (I) ionizing radiation such as gamma rays or accelerated electrons, (II) thermal modification, (III) additional stabilization with vitamin E, and (IV) sterilization. According to the modifications, we usually differentiate three generations of UHMWPE. The 1st generation UHMWPE is not modified except for obligatory sterilization. The sterilization procedures based on chemical procedures (formaldehyde vapours, hot water) have lately been forbidden, abandoned and replaced by gamma-irradiation with doses of 25-45 kGy. In the course of time, sterilization by means of gamma-irradiation showed to be unsuitable due to oxidative degradation of UHMWPE, which resulted in lower wear resistance, worse material properties and a decrease in longevity of joint replacements. The 2nd generation UHMWPE or highly cross-linked UHMWPE is material treated with ionizing radiation (gamma-rays or accelerated electrons) at higher doses (usually 50-100 kGy). The irradiation is followed by thermal treatment in order to eliminate residual radicals and limit oxidative degradation that occurs in the 1st generation UHMWPE types. Finally, the material is sterilized usually by modern procedures using ethylene oxide or gas plasma neither of which causes oxidative degradation (as opposed to gamma-irradiation sterilization). The 3rd generation UHMWPE is basically the same as that of the 2nd generation. The main difference consists in slightly better mechanical properties (strength, fatigue) and further stabilization to oxidative degradation. This is achieved by special procedures, some of which are either controversial (sequential irradiation) or well-accepted by a great majority of the orthopaedic community (vitamin E stabilization). Only the future will show whether the difference between the 2nd and 3rd generations of UHMWPE will play any role in increasing TJR longevity and therefore the quality of its performance. The final objective of all of UHMWPE modifications is, as already mentioned, to increase wear resistance, oxidative resistance and mechanical performance of the polymer. These changes, especially an increase in wear resistance, have been confirmed to prolong the longevity of total joint replacements based on UHMWPE.

摘要

超高分子量聚乙烯(UHMWPE)是目前使用的全关节置换术(TJR)中最常用的承重表面材料。根据现有文献,就生物相容性、机械性能和耐磨性而言,UHMWPE是此应用中最佳的聚合物材料。尽管如此,UHMWPE磨损(即聚合物表面微观颗粒的释放)仍然是TJR失败的主要原因之一。因此,UHMWPE的磨损是材料科学家和骨科医生深入研究的课题。UHMWPE的结构和性能在很大程度上取决于加工方式和后处理改性。加工过程包括聚合物树脂制备(约100μm大小的微粒)和树脂固结(形成块状材料)。后处理改性旨在提高耐磨性和氧化稳定性,这被视为TJR失败的主要相关因素。为了保持用于医疗应用的材料的高纯度,在改性过程中不允许使用额外的化学物质。唯一的例外是使用维生素E,一种天然稳定剂和抗氧化剂。考虑到上述所有事实,改性可基于:(I)电离辐射,如伽马射线或加速电子;(II)热改性;(III)用维生素E进行额外稳定化处理;以及(IV)灭菌。根据改性情况,我们通常将UHMWPE分为三代。第一代UHMWPE除了必须进行的灭菌外未作改性。基于化学程序(甲醛蒸汽、热水)的灭菌程序最近已被禁止、废弃,并被剂量为25 - 45 kGy的伽马射线辐照所取代。随着时间的推移,由于UHMWPE的氧化降解,伽马射线辐照灭菌显示出不合适,这导致耐磨性降低、材料性能变差以及关节置换的使用寿命缩短。第二代UHMWPE或高度交联的UHMWPE是用较高剂量(通常为50 - 100 kGy)的电离辐射(伽马射线或加速电子)处理的材料。辐照后进行热处理,以消除残留自由基并限制第一代UHMWPE类型中发生的氧化降解。最后,通常采用现代程序用环氧乙烷或气体等离子体对材料进行灭菌,这两种方法都不会引起氧化降解(与伽马射线辐照灭菌相反)。第三代UHMWPE与第二代基本相同。主要区别在于机械性能(强度、疲劳性)略好,并且对氧化降解有进一步的稳定作用。这是通过特殊程序实现的,其中一些程序存在争议(顺序辐照),而另一些则被大多数骨科界人士广泛接受(维生素E稳定化)。只有未来才能表明第二代和第三代UHMWPE之间的差异是否会在提高TJR使用寿命从而提高其性能质量方面发挥任何作用。如前所述,所有UHMWPE改性的最终目标是提高聚合物的耐磨性、抗氧化性和机械性能。这些变化,尤其是耐磨性的提高,已被证实可延长基于UHMWPE的全关节置换的使用寿命。

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