CN201312845Y - 一种抗菌人工关节假体 - Google Patents
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Abstract
本实用新型公开的一种抗菌人工关节假体，其特征在于在人工关节假体与人体骨面接触部位是由人工关节假体基材层和覆盖其上的、厚度为5～350μm含金属银涂层构成。由于本实用新型提供的人工关节假体表面具有的金属银或金属银/羟基磷灰石涂层既能持续地释放出杀菌的银离子，又能在进入菌体使其失去活性后从菌体中游离出来，重复进行杀菌，因而不仅使得这种新型人工假体在植入人体后发生感染、松动的并发症的可能性大为降低，还避免了已有的抗生素骨水泥层所产生的一系列问题，且具有极好的生物相容性和生物活性。
Description
技术领域
本实用新型属于医疗器械技术领域，具体涉及一种可植入人体内的抗菌人工关节假体。
背景技术
人工关节假体自100多年前应用于临床以来，虽获得了巨大的发展，但仍然有许多问题尚需解决，如植入人体后产生的感染问题。据统计，全髋关节置换术后，感染率为0.1％～1％；全肘关节感染率为1％～4％；而膝关节则达到4％～47％。众所周知，人工关节假体感染是一种灾难性的并发症。究其原因，生物被膜(biofilm)是引起人工关节假体感染的主要因素。生物被膜是细菌为了适应生存环境而粘附于生物材料或活性组织表面，并包被在自身产生的粘液性蛋白多糖基质中而形成的细菌群落或微克隆，它是一个不断变化的动态结构(Costerton JW，StewartPS，Greenberg EP.Bacterialbiofilms：a common cause of persistent infections.Science，1999；284(5418)：1318-1322)。当人工关节假体植入体内后，表面立即被血液成分(蛋白、血浆大分子、红细胞、血小板)覆盖，形成所谓的条件膜，细菌通过化学作用，如范德华力、酸根、静电、疏水性作用及蛋白结合等，粘附在条件膜和假体表面。机体免疫力正常时，多数浮游菌被杀死，少数残存细菌粘附到材料表面之后调整基因表达，在生长繁殖的同时分泌大量胞外粘质物(extracellular slime substance，ESS)，将多个细菌粘连到一起形成生物被膜。平时，细菌多以休眠状态藏匿于生物被膜中，当有特定触发因素时即从休眠或静止状态转变为致病菌。感染一旦发生就会使假体产生松动，丧失正常功能，给患者带来极大的痛苦，且感染还会反复发作，迁延难愈(Nelson CL，Mclaren AC，Mclarten SG，et al.Is aseptic loosening truly aseptic？Clin Orthop，2005；437：25-30)，而常规的抗生素疗法很难奏效，因而人工关节置换术后感染的预防和治疗一直是该领域中一项极其重要的课题。继而有人研究成功了在普通聚甲基丙烯酸甲酯(PMMA)骨水泥中添加抗生素而在人工关节假体表面形成抗生素骨水泥(antibiotic impregnated bone cement)层来作为解决感染较为常用的方法一(Espehaug B，Engesaerer LB，Voll set SE，et al.Antibioticpro ylaxis in total hip arthroplasty.Review of 10，905 primary cemented totalhip replacements reported to the Norwegian arthroplasty register，1987 to1995[J].J Bone Joint surg(Br)，1997，79(4)：590-595)。但经使用后发现，抗生素骨水泥长期释放低浓度抗生素，容易使细菌产生耐药性，而且随着添加抗生素的增多，过敏反应发生的几率也很高，且一旦发生处理困难，必须取出假体，这不仅会给病人带来极大的痛苦，而且还要带来过重的经济负担。
发明内容
本实用新型的目的是针对已有技术的问题，提供一种抗菌人工关节假体，以极大的减少植入后人工关节假体的感染及松动的发生率。
本实用新型提供的一种抗菌人工关节假体，其特征在于在人工关节假体在植入后与人体骨面接触部位是由人工关节假体基材层和覆盖其上的金属银层构成。
由于在植入的人工关节假体表面有金属银涂层，因而当其与体液等氧化介质接触后，金属银将逐渐被氧化而释放出银离子，当微量银离子到达微生物细胞膜时，因细胞膜带有负电荷，银离子首先会依靠库伦力牢固吸附在细胞膜上，然后进一步穿透细胞壁进入病菌内，与病菌生物体内的蛋白质、核酸中存在的巯基(-SH)、氮基(-NH2)等含硫、氨的官能团发生反应，使病菌的蛋白质凝固，破坏病菌的细胞合成酶的活性，使细胞丧失分裂增殖能力而最终消亡，从而达到抗菌并减少或消除人工关节假体相关感染发生的目的。
为了使本实用新型提供的人工关节假体不仅具有抗菌作用，还具有良好的生物相容性，本实用新型提供的人工关节假体是在人工关节假体与人体骨面接触部位是由人工关节假体基材层和覆盖其上的金属银/羟基磷灰石层或金属银层构成。上述假体基材层可为含微孔的基材层或不含微孔的基材层。
本实用新型提供的抗菌人工关节假体，其覆盖在人工关节假体基材层上的金属银/羟基磷灰石层或金属银层的厚度为5～350μm。
覆盖在本实用新型人工关节假体基材层上的金属银/羟基磷灰石层或金属银层可采用已有的常规真空等离子喷涂、电子直线加速器辐照、低能离子束溅射沉积、电沉积烧结、磁控溅射等方法来制备形成。
目前，人工关节假体感染最主要的致病菌为葡萄球菌。为了考察本实用新型提供的抗菌人工关节假体的抗菌效果，本实用新型将家兔作为实验对象，分别采用普通的未镀银的人工关节假体做对照组，以覆盖了金属银/羟基磷灰石层的人工关节假体为实验组，行髋关节置换手术，术后即刻在股骨的髓质部分注入1×107CFU的金黄色葡萄球菌，4周后分别进行放射学检查、细菌学检测以及血清C—反应蛋白(C—reactiveprotein，CRP)的测定。结果发现抗菌关节假体组感染率明显低于普通关节组。
本实用新型具有以下优点：
1、由于本实用新型提供的人工关节假体表面具有的金属银涂层既能持续地释放出杀菌的银离子，又能在进入菌体使其失去活性后从菌体中游离出来，重复进行杀菌，因而不仅使得这种新型人工假体在植入人体后发生感染、松动的并发症的可能性大为降低，还避免了已有的抗生素骨水泥层所产生的一系列问题。
2、由于本实用新型提供的人工关节假体表层在具有了金属银的基础上，还含有与生物骨组织中的磷酸钙无机物相似的羟基磷灰石，因而使得该人工关节假体还具有极好的生物相容性和生物活性。
3、由于本实用新型人工关节假体基材层上的金属银/羟基磷灰石层中的Ag的热膨胀系数比羟基磷灰石(HA)高，使得羟基磷灰石在用电沉积烧结时从烧结温度冷却到室温的过程会产生压应力，不仅可有效抑制裂纹的扩展，使HA/Ag复合涂层的结合强度明显提高，还因包含具有一定延展性的金属Ag，使涂层的韧性也能够有所提高。
附图说明
图1为人工髋关节假体的结构示意图；
图2为人工膝关节假体胫骨侧的结构示意图；
图3为人工膝关节假体股骨侧的结构示意图；
图4为人工关节假体上有金属银层或金属银/羟基磷灰石层部位的剖视结构示意图。
具体实施方式
下面结合附图给出实施例以对本实用新型进行具体描述，有必要在此指出的是以下实施例只用于对本实用新型作进一步说明，不能理解为对本实用新型保护范围的限制，该领域的技术熟练人员根据上述本实用新型内容对本实用新型所作出的一些非本质的改进和调整，仍属于本实用新型的保护范围。
实施例1
首先用制备人工关节假体的基材，如钴合金或钛合金加工成如图1所示的髋关节假体1，此假体可做成含微孔表面的假体或不含微孔表面的普通假体，然后再在其球头2外表面和其柄3的下半部分的外表面(即图1中涂黑部分)用磁控溅射喷涂一层厚度为6μm的金属银层8，使在人工关节髋假体1与人体骨面接触的球头2外表面和其柄3的下半部分的部位是由人工关节假体基材层7和覆盖其上的金属银层8构成，如图4所示。
实施例2
首先用制备人工关节假体的基材，如钴合金或钛合金加工成如图1所示的髋关节假体1，此假体可做成含微孔表面的假体或不含微孔表面的普通假体，然后再在其球头2外表面和其柄3的下半部分的外表面(即图1中涂黑部分)用电沉积烧结法沉积烧结一层厚度为280μm的金属银/羟基磷灰石层8，使在人工髋关节假体1与人体骨面接触的球头2外表面和其柄3的下半部分的部位是由人工关节假体基材层7和覆盖其上的金属银/羟基磷灰石层8构成，如图4所示。
实施例3
首先用制备人工关节假体的基材，如钴合金或钛合金加工成如图2、3所示的膝关节胫骨侧假体4或膝关节股骨侧假体6，此假体可做成含微孔表面的假体或不含微孔表面的普通假体，然后分别再在胫骨侧假体4胫骨基座的下表面，包括整个植入柱5的外表面(即图2中涂黑部分)和膝关节股骨侧假体6的内表面(即图3中涂黑部分)用真空等离子喷涂一层厚度为40μm的金属银层8，使在人工膝关节假体与人体骨面接触的膝关节胫骨侧假体4基座的下表面，包括整个植入柱5的外表面或膝关节股骨侧假体6的内表面部位是由人工关节假体基材层7和覆盖其上的金属银层8构成，如图4所示。
实施例4
首先用制备人工关节假体的基材，如钴合金或钛合金加工成如图2、3所示的膝关节胫骨侧假体4或膝关节股骨侧假体6，此假体可做成含微孔表面的假体或不含微孔表面的普通假体，然后分别再在胫骨侧假体4胫骨基座的下表面，包括整个植入柱5的外表面(即图2中涂黑部分)和膝关节股骨侧假体6的内表面(即图3中涂黑部分)用真空等离子喷涂一层厚度为100μm的金属银/羟基磷灰石层8，使在人工膝关节假体与人体骨面接触的膝关节胫骨侧假体4基座的下表面，包括整个植入柱5的外表面或膝关节股骨侧假体6的内表面部位是由人工关节假体基材层7和覆盖其上的金属银/羟基磷灰石层8构成，如图4所示。
Claims (3)
1、一种抗菌人工关节假体，其特征在于在人工关节假体与人体骨面接触部位是由人工关节假体基材层(7)和覆盖其上的含金属银涂层(8)构成。
2、根据权利要求1所述的抗菌人工关节假体，其特征在于在人工关节假体与人体骨面接触部位是由人工关节假体基材层(7)和覆盖其上的金属银/羟基磷灰石层(8)或金属银层(8)构成。
3、根据权利要求1或2所述的抗菌人工关节假体，其特征在于覆盖在人工关节假体基材层上的金属银层(8)或金属银/羟基磷灰石层(8)的厚度为5～350μm。
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103298499A (zh) * | 2010-10-05 | 2013-09-11 | 德鲁有限责任公司 | 具有抗菌涂层滑动表面的假体组件 |
| CN104127914A (zh) * | 2014-07-29 | 2014-11-05 | 复旦大学附属华山医院 | HAp掺合银和铜抗菌剂复合涂层的制备方法 |
| CN104353117A (zh) * | 2014-11-18 | 2015-02-18 | 孙钢 | 一种使骨水泥后续产生热量的方法 |
| CN105559948A (zh) * | 2015-12-14 | 2016-05-11 | 北京大学第一医院 | 一种人工关节假体 |
| CN113101414A (zh) * | 2021-03-18 | 2021-07-13 | 常熟中科世纪生物科技有限公司 | 一种具有抗感染功能的人工关节假体 |
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2008
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103298499A (zh) * | 2010-10-05 | 2013-09-11 | 德鲁有限责任公司 | 具有抗菌涂层滑动表面的假体组件 |
| CN104127914A (zh) * | 2014-07-29 | 2014-11-05 | 复旦大学附属华山医院 | HAp掺合银和铜抗菌剂复合涂层的制备方法 |
| CN104353117A (zh) * | 2014-11-18 | 2015-02-18 | 孙钢 | 一种使骨水泥后续产生热量的方法 |
| CN104353117B (zh) * | 2014-11-18 | 2016-01-20 | 孙钢 | 一种使骨水泥后续产生热量的方法 |
| CN105559948A (zh) * | 2015-12-14 | 2016-05-11 | 北京大学第一医院 | 一种人工关节假体 |
| CN105559948B (zh) * | 2015-12-14 | 2018-12-18 | 北京大学第一医院 | 一种人工关节假体 |
| CN113101414A (zh) * | 2021-03-18 | 2021-07-13 | 常熟中科世纪生物科技有限公司 | 一种具有抗感染功能的人工关节假体 |
| CN113101414B (zh) * | 2021-03-18 | 2023-03-14 | 常熟中科世纪生物科技有限公司 | 一种具有抗感染功能的人工关节假体 |
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