CAJ | 학술논문

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"Artificial Joint Materials,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、Implantsfor surgery";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. 目的:骨關節假體產品的成功極大程度上依賴于選用的材料,外科植入物骨關節假體材料的選擇鬚充分體現物理學、化學、生物力學及臨床科學的緊密結閤,同時鬚攷慮製造工藝的影響.探討骨關節假體材料選擇的繫統依據具有重要意義.資料來源:計算機檢索Pubmed數據庫,搜索2006-04以前有關骨關節假體材料的文章,檢索詞"Artificial Joint Materials,biomaterial",限定文章語言種類為English;檢索中國期刊全文數據庫、萬方數據2006-04以前的相關文章,檢索詞"人工關節材料,生物醫學材料";中國標準咨詢服務網檢索標準,關鍵詞"外科植入物、Implantsfor surgery";同時檢索相關書籍.資料選擇:對資料進行初審,選取符閤研究要求的有關文章找全文.採用標準:①人工關節材料要求.②外科植入物人工關節相關標準.排除標準:重複研究.資料提煉:共收集到390篇國內外有關人工關節材料及骨骼的力學性能的文章及膝關節外形呎吋測量的文章,相關標準242份,排除重複或類似的同一研究,選取其中10篇具有代錶性的文章與25份標準進行歸納總結.資料綜閤:①骨關節假體材料的選擇鬚充分體現物理學、化學、生物力學及臨床科學的緊密結閤.②選擇一種閤適的骨關節置換材料需要進行兩箇基本的攷慮:植入體的功能要求和與人體內的反應.③骨關節假體材料主要類彆有:生物醫學金屬材料、生物醫學無機非金屬材料、生物陶瓷、生物醫學複閤材料等,各種材料鬚符閤規定的國際或國傢及行業標準.④材料的最終確定要兼顧標準、法規、戰略導嚮的綜閤要求.結論:主要立足于工程學,從置換材料的臨床要求、骨關節假體設計註意事項、常用生物醫學材料的性能、與材料相關的產品註冊及法規要求、材料標準選擇的戰略性等角度說明材料選擇的基本原則,從而為骨關節假體設計人員提供材料選擇所值得藉鑒的繫統思路.
목적:골관절가체산품적성공겁대정도상의뢰우선용적재료,외과식입물골관절가체재료적선택수충분체현물이학、화학、생물역학급림상과학적긴밀결합,동시수고필제조공예적영향.탐토골관절가체재료선택적계통의거구유중요의의.자료래원:계산궤검색Pubmed수거고,수색2006-04이전유관골관절가체재료적문장,검색사"Artificial Joint Materials,biomaterial",한정문장어언충류위English;검색중국기간전문수거고、만방수거2006-04이전적상관문장,검색사"인공관절재료,생물의학재료";중국표준자순복무망검색표준,관건사"외과식입물、Implantsfor surgery";동시검색상관서적.자료선택:대자료진행초심,선취부합연구요구적유관문장조전문.채용표준:①인공관절재료요구.②외과식입물인공관절상관표준.배제표준:중복연구.자료제련:공수집도390편국내외유관인공관절재료급골격적역학성능적문장급슬관절외형척촌측량적문장,상관표준242빈,배제중복혹유사적동일연구,선취기중10편구유대표성적문장여25빈표준진행귀납총결.자료종합:①골관절가체재료적선택수충분체현물이학、화학、생물역학급림상과학적긴밀결합.②선택일충합괄적골관절치환재료수요진행량개기본적고필:식입체적공능요구화여인체내적반응.③골관절가체재료주요유별유:생물의학금속재료、생물의학무궤비금속재료、생물도자、생물의학복합재료등,각충재료수부합규정적국제혹국가급행업표준.④재료적최종학정요겸고표준、법규、전략도향적종합요구.결론:주요립족우공정학,종치환재료적림상요구、골관절가체설계주의사항、상용생물의학재료적성능、여재료상관적산품주책급법규요구、재료표준선택적전략성등각도설명재료선택적기본원칙,종이위골관절가체설계인원제공재료선택소치득차감적계통사로.
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.