外科植入物骨关节假体材料的选择

目的:骨关节假体产品的成功极大程度上依赖于选用的材料,外科植入物骨关节假体材料的选择须充分体现物理学、化学、生物力学及临床科学的紧密结合,同时须考虑制造工艺的影响。探讨骨关节假体材料选择的系统依据具有重要意义。资料来源:计算机检索Pubmed数据库,搜索2006-04以前有关骨关节假体材料的文章,检索词“ArtificialJointMaterials,biomaterial”,限定文章语言种类为English;检索中国期刊全文数据库、万方数据2006-04以前的相关文章,检索词“人工关节材料,生物医学材料”;中国标准咨询服务网检索标准,关键词“外科植入物、Implantsforsurgery”;同时检索相关书籍。资料选择:对资料进行初审,选取符合研究要求的有关文章找全文。采用标准:①人工关节材料要求。②外科植入物人工关节相关标准。排除标准:重复研究。资料提炼:共收集到390篇国内外有关人工关节材料及骨骼的力学性能的文章及膝关节外形尺寸测量的文章,相关标准242份,排除重复或类似的同一研究,选取其中10篇具有代表性的文章与25份标准进行归纳总结。资料综合:①骨关节假体材料的选择须充分体现物理学、化学、生物力学及临床科学的紧密结合。②选择一种合适的骨关节置换材料需要进行两个基本的考虑:植入体的功能要求和与人体内的反应。③骨关节假体材料主要类别有:生物医学金属材料、生物医学无机非金属材料、生物陶瓷、生物医学复合材料等,各种材料须符合规定的国际或国家及行业标准。④材料的最终确定要兼顾标准、法规、战略导向的综合要求。结论:主要立足于工程学,从置换材料的临床要求、骨关节假体设计注意事项、常用生物医学材料的性能、与材料相关的产品注册及法规要求、材料标准选择的战略性等角度说明材料选择的基本原则,从而为骨关节假体设计人员提供材料选择所值得借鉴的系统思路。

Selection of materials for joint prosthesis in surgical implants

OBJECTIVE: The success of joint prosthesis greatly depends on the materials, which should be a perfect combination of physics, chemistry, biomechanics and clinical sciences in choice of them. In addition, the effect of manufacture technology can not be neglected. So, it is significant to probe into the systematic basis in materials selection of joint prosthesis.DATA SOURCES: A computer-based search was conducted in Pubmed database for articles about joint prosthesis published before April 2006 with the key words of "artificial joint materials, biomaterial", and the language was limited to English. Meanwhile, Chinese Journal Full-text Database (CJFD) and Wanfang database were looked for relevant literatures published before April 2006 with the key words of "artificial joint material, biomedical material", and the language was limited to Chinese. Besides,the standards for materials were searched in Chinese service net for standard consultation with the key words of "implants for surgery" in both Chinese and English. At the same time, relevant books were also manually searched.STUDY SELECTION: Data were checked in the first trial, and related articles according to the criteria of research were looked for the full text.Inclusion criteria: ① Requirements for artificial joint material. ② Relevant standards for artificial joint of surgical implants. Exclusion criteria: Repetitive studies were excluded.DATA EXTRACTION: A total of 390 domestic and overseas articles,which were in relation to the mechanical properties of artificial joint material and bone and measurement of the overall dimensions of knee joint,were collected. There were still 242 relevant standards, while the repetitive studies and similar researches were excluded. Ten typical articles and 25 standards in collection were summed up and reviewed.DATA SYNTHESIS: ①Close combination of physics, chemistry, biomechanics and clinical sciences is sufficiently embodied in the selection of the materials. ② Two aspects must be taken into consideration: Requirements for function of the implant and the responses inside the human body.③ Main types of materials for joint prosthesis: biomedical metallic material, biomedical inorganic material of nonmetal, bioceramic, biomedical compound materials and so on. All kinds of materials that have been adopted should accord with the international or state or trade standards.④ The final determination of materials should meet the comprehensive requirements of standards, laws and regulations, as well as strategic targeting. CONCLUSION: Based on engineering, the fundamental principles of materials selection for joint prosthesis are illustrated from the following angles: clinical requirements for materials of replacement, attentions in joint prosthesis design, commonly used biomedicine materials performance, requirements of product registration and laws & regulations related to the materials, the strategy in the choice of material standard etc. As a result, a valuable system approach is provided for joint-prosthesis designers to select materials.