CN103298499A - 具有抗菌涂层滑动表面的假体组件 - Google Patents

具有抗菌涂层滑动表面的假体组件 Download PDF

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CN103298499A
CN103298499A CN2011800484199A CN201180048419A CN103298499A CN 103298499 A CN103298499 A CN 103298499A CN 2011800484199 A CN2011800484199 A CN 2011800484199A CN 201180048419 A CN201180048419 A CN 201180048419A CN 103298499 A CN103298499 A CN 103298499A
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R·图尔
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Waldemar Link GmbH and Co KG
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Abstract

本发明涉及一种关节内假体的假体组件(11、23)，所述假体组件(11、23)包括滑动表面(19、24)，其设计为与另一假体组件(11、23)的匹配滑动表面(26)形成滑动关节。滑动表面(19、24)可以由滑动表面涂层(20)形成，所述滑动表面涂层(20)沉积在假体组件(10、22)的主体上，其中所述滑动表面涂层(20)具有抗菌作用。滑动表面涂层对滑动关节区域内的微生物具有活性。

Description

具有抗菌涂层滑动表面的假体组件
本发明涉及一种关节内假体(joint endoprosthesis)的假体组件(prosthesiscomponent)。假体组件包括滑动表面，其适于与匹配滑动表面形成滑动关节。匹配滑动表面可以是另一假体组件的表面、或关节的相应的骨支撑、和/或软组织。
由于人体无法耐受假体而没有并发症，因此将假体植入人体内通常会产生困难。并发症通常由所谓的生物膜引起，其会在植入状态以及在细菌已在表面大量繁殖后形成。可以发现，风险不仅从植入状态下直接贴近人体组织的假体的表面区域产生，而还从用于与其它假体组件接合的那些表面区域产生。这些表面区域特别是包括与其它假体组件接合以复制自体关节功能的假体组件的那些滑动表面。这些区域中的表面生物膜很大程度上超出了人体防御机制的控制。生物膜继续从滑动表面区域释放微生物到周围区域是存在风险的。微生物从滑动表面区域蔓延进入周围区域的趋势会由于滑动表面的频繁运动这一事实而进一步增强。
假体的滑动表面相比表面的其余区域而言承受完全不同等级的载荷。同时，关节中会产生相对运动，人体的几乎全部重量，加上加速力，在工作时都作用在假体的滑动表面上。在这些条件下，很难阻止微生物的蔓延。
当从该现有技术开始着手时，本发明基于提供一种假体组件的目的，其在植入人体时不太可能引起并发症。该目的通过权利要求1的特征来实现。根据本发明，假体组件具有滑动表面涂层，所述滑动表面涂层具有抗菌活性。在从属权利要求中可获得有益的实施方式。
首先将解释一些术语。具有抗菌活性的涂层通过减弱微生物的生存能力或生殖能力的潜力而自身与众不同。这通常通过从涂层中释放具有抗菌活性的物质实现。
假体的滑动关节由第一假体组件的滑动表面和第二假体组件的相关匹配滑动表面形成。在一连串移动期间，滑动表面和匹配滑动表面之间的接触会涉及滑动表面的不同表面区域。术语滑动表面包括关节在假体内运动时可能与匹配滑动表面接触的所有表面区域。
当在主体上施加涂层时，就给主体增加了额外的材料。全部由新增加的材料组成的层会在主体的表面上产生。并不排除根据本发明的涂层也可能施加至除滑动表面之外的假体组件的表面区域。然而，通常情况下，其它表面区域不具有任何涂层，而只有滑动表面被涂覆。
由于根据本发明的涂层，抗菌作用被引入滑动表面区域，并因此进入人体防御无法到达的区域。如果滑动表面区域中没有抗菌作用，则微生物就会粘附于上并继续反复繁殖。根据本发明的抗菌涂层作用于微生物，从而阻止了并发症的风险。
假体表面上的抗菌涂层是公知的，例如参见EP2036517。然而，到目前为止，它们仅预期用于承受很小机械载荷的假体的表面区域。
体内特别适用的抗菌剂是银。从涂层释放的银粒子对粘附到涂层表面的微生物具有良好效果。如果银粒子扩散到涂层外而没有遇见微生物，它们会在体内电解液中结合而形成氯化银(AgCl)，并且能够以这种形式排出体外。于是，银对其他身体细胞不存在有害作用。因此，滑动表面涂层优选地包括银。银优选地从滑动表面涂层中以单个银离子的形式释放。
关节假体的滑动表面承受高等级的机械载荷。滑动表面的高承载能力可通过滑动表面涂层为硬质材料涂层来实现。优选地，滑动表面涂层包括难熔金属基氮化物、氧氮化物或氧化物。有利地，滑动表面涂层此外还包含可从涂层释放的银。难熔金属为第4、5、6族的贱金属(base metal)，其具有高熔点。它们包括第4族中的钛、锆和铪，第5族中的钒、铌和钽，以及第6族中的铬、钼和钨。钛、锆、铌和钽是特别适于涂覆假体内组件的难熔金属。在难熔金属离子与作为活性气体的氧和/或氮结合时形成的那些化合物，被称为难熔金属基氮化物、氧氮化物或氧化物。这些化合物因为极大的硬度而自身与众不同。在滑动表面涂层此外还包括银时，氮化物、氧氮化物或氧化物的形成中不仅包含难熔金属的离子，此外还包含银离子。银离子结合到得到的涂层中。
利用包含银的硬质材料涂层，抗菌活性随着银含量的增加而增强。如果涂层的设计主要集中在高抗菌活性上，在硬质材料涂层中可选择约25％重量比的银。然而，与不包含银的硬质材料涂层相比，其机械承载能力会显著减小。因此，为了本发明的目的，在硬质材料涂层中应当选择较低重量比的银。重量比优选地处于2％到15％之间的范围，更优选地为3％到10％之间。可以看到，利用这样的低银含量，在机械承载能力和抗菌作用之间达到了良好平衡。
滑动表面涂层应形成为使得银主要以单个银离子的形式释放，而不是以较大粒子的形式释放。单个银离子能够在滑动表面之间起作用，而不对滑动表面产生磨耗作用。
假体组件的主体可由金属或金属合金组成。钛或钛合金为特别适合的材料。
例如，根据本发明的滑动表面涂层可通过PVD(物理气相沉积)过程施加至假体组件的主体。为此，提供靶标用于溶出材料，随后形成涂层。可提供单个靶标，其包括难熔金属和银。然而，还可能提供多个靶标，其中第一靶标包括难熔金属，以及第二靶标包括银。
为了溶出离子，例如可以在电极和靶标之间产生电弧，其以局部有限的方式为靶标提供足以使离子溶出的能量。为靶标提供局部足够能量的另一种可能性是将激光光束引导在靶标上。虽然非常昂贵，一种可替代的可能性是利用电子束提供能量。
自由离子流通到假体组件的主体上。为此，在靶标和主体之间施加电压，通过该方式离子朝向主体加速。靶标和主体的反应容器容纳活性气体，例如氧气或氮气或氧气和氮气的混合物。难熔金属离子、以及银和/或铜离子，与活性气体反应。由于该反应发生在主体表面上，会形成根据本发明的滑动表面涂层。该反应可在真空下发生，优选地在高度真空下。
如果阻止涂层在假体组件滑动表面之外的表面区域形成，这些表面区域在涂覆过程中可进行遮蔽。这些表面区域例如可用热稳定材料覆盖。耐受等离子涂覆过程中主导条件的任何材料被指定为热稳定的。特别地，热稳定材料可以是金属。
为了在滑动表面和匹配滑动表面之间的运动期间将磨耗保持为最小，滑动表面应当尽可能平滑。根据DIN EN ISO 4288和3274确定，滑动表面的平均粗糙度Ra优选地小于0.05μm。
此外，本发明涉及一种关节内假体，具有根据本发明设计的第一假体组件以及具有第二假体组件。第二假体组件包括匹配滑动表面，其与第一假体组件的滑动表面形成滑动关节。
现将基于有益实施方式的实例，参照附图描述本发明，其中：
图1示出了根据本发明装备的髋关节内假体；
图2示出了图1的放大细节；以及
图3示出了根据本发明装配的膝关节内假体。
图1中所示的髋关节内假体包括股骨组件10和髋臼组件(acetabularcomponent)11。股骨组件10包括股骨柄12，其插入股骨13的骨髓腔中。股骨柄12之后是假体颈14，其形成进入关节头15的过渡。髋臼组件11结合到髋骨16中，它在此处替代自体髋臼。髋臼组件11包括金属外壳17、以及由高密度聚乙烯制成的附着件18。
当植入时，关节头15位于聚乙烯附着件18中，从而关节头15与聚乙烯附着件18形成滑动关节。因而，关节头15的表面作为滑动表面19与聚乙烯附着件18的匹配滑动表面26接合。滑动表面的平均粗糙度Ra小于0.03μm。
股骨组件10由钛合金制成。如图2中以很大的放大尺度所示，滑动表面涂层20施加到滑动表面区域19中的关节头15。滑动表面涂层20通过PVD过程产生并具有约3μm的厚度。滑动表面涂层20由氮化钛组成，其中包含被包封的银原子21，而银离子未按比例示出。在滑动表面涂层20中，银离子占约5％的重量比。
银以单独原子的形式包含在滑动表面涂层20中，而不是以较大粒子的形式存在。在使用假体期间，单个银离子从滑动表面涂层20溶出。银离子在滑动关节区域发挥抗菌作用。单个银离子足够小从而不会对聚乙烯附着件18产生磨耗作用。
图3示出了装配有根据本发明的滑动表面涂层的膝关节假体。膝关节假体包括股骨组件22和胫骨组件23。股骨组件22的滑动表面24与胫骨组件23的聚乙烯附着件25接合，并形成再生天然膝盖功能的滑动关节。
股骨组件22和胫骨组件23由传统的铬钴合金组成。如图2中所示的抗菌滑动表面涂层20施加到股骨组件22的滑动表面24上。
在图3的膝关节假体中，始终只有滑动表面24的很小的表面区域位于聚乙烯附着件25上。各个表面区域根据膝关节假体的运动状态而改变。滑动表面涂层20遍布整个滑动表面24，即，遍布可能与聚乙烯附着件25接触的所有表面区域。从滑动表面涂层20扩散出的银离子具有对粘附其上的微生物的抗菌作用。

Claims (9)

1.关节内假体的假体组件，其包括滑动表面(19、24)，所述滑动表面(19、24)适于与另一假体组件(11、23)的匹配滑动表面(26)、或关节的相应的骨支撑、和/或软组织形成滑动关节，其特征在于，所述滑动表面(19、24)由施加到所述假体组件(10、22)的主体上的滑动表面涂层(20)形成，并且所述滑动表面涂层(20)具有抗菌作用。
2.根据权利要求1所述的假体组件，其特征在于所述滑动表面涂层(20)包含银。
3.根据权利要求1或2所述的假体组件，其特征在于所述滑动表面涂层(20)包含难熔金属基氮化物、氧氮化物或氧化物。
4.根据权利要求3所述的假体组件，其特征在于所述难熔金属是钛。
5.根据权利要求3或4所述的假体组件，其特征在于银(21)在所述滑动表面涂层(20)中占2％至15％的重量比，优选3％至10％的重量比。
6.根据权利要求3至5中任一项所述的假体组件，其特征在于所述滑动表面涂层(20)具有0.5μm至5μm的厚度。
7.根据权利要求3至6中任一项所述的假体组件，其特征在于所述滑动表面涂层(20)可以通过PVD方法获得。
8.根据权利要求1至7中任一项所述的假体组件，其特征在于所述滑动表面(19、24)的平均粗糙度Ra小于0.05μm。
9.关节内假体，其具有根据权利要求1至8中任一项设计的第一假体组件和具有匹配滑动表面(26)的第二假体组件(11、23)，其中所述第一假体组件的滑动表面(19、24)与所述第二假体组件(11、23)的匹配滑动表面(26)形成滑动关节。
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