CN101801315B - 内置式假肢部件 - Google Patents

内置式假肢部件 Download PDF

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Publication number
CN101801315B
CN101801315B CN2008801080701A CN200880108070A CN101801315B CN 101801315 B CN101801315 B CN 101801315B CN 2008801080701 A CN2008801080701 A CN 2008801080701A CN 200880108070 A CN200880108070 A CN 200880108070A CN 101801315 B CN101801315 B CN 101801315B
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China
Prior art keywords
skin
endoprosthesis component
intermediate layer
endoprosthesis
silver
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CN2008801080701A
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CN101801315A (zh
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罗格·图尔
赫尔穆特·D·林克
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Waldemar Link GmbH and Co KG
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Waldemar Link GmbH and Co KG
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Landscapes

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Abstract

本发明涉及一种内置式假肢部件(17)以及一种用于制备内置式假肢部件(17)的方法。内置式假肢部件(17)具有一设定内置式假肢部件(17)形状的物体(23)。具有一外层(25)的所述物体(23)布置在内置式假肢部件在植入状态下与人体组织接触的表面部分(22)上，所述外层(25)含有基于一难熔金属的氮化物、氧氮化物或氧化物，其中，所述外层(25)中还含有银和/或铜。根据本发明，一中间层(24)布置在所述外层(25)与物体(23)之间，可从外部接触所述中间层(24)部分。使用根据本发明的方法制造内置式假肢部件(17)。通过本发明，可通过使外层(25)实现长效的抗菌作用，并且可以额外地从中间层(24)向周围的组织发挥抗菌作用。

Description

内置式假肢部件
技术领域
本发明涉及一种内置式假肢部件，其具有一设定内置式假肢部件形状的物体。具有一外层的所述物体布置在内置式假肢部件在植入状态下与人体组织接触的表面部分上。所述外层含有基于一难熔金属的氮化物、氧氮化物或氧化物，所述外层中还含有银和/或铜。本发明还涉及一种制备所述内置式假肢部件的方法。 
背景技术
作为人体骨骼组成部分的内置式假肢部件必须要满足多种要求。内置式假肢部件必须足够稳固，这样才能承受在骨骼之中产生的力。此外，内置式假肢部件在植入状态下与包括骨骼在内的人体组织接触的组成部分必须具有良好的相容性。 
已知情况为，在内置式假肢部件与人体组织接触的表面部分上设置由硬材料构成的涂层，硬材料例如为基于一难熔金属的氮化物、氧氮化物或氧化物。这种类型的硬材料涂层机械性能好且相容性良好。 
但在将这种内置式假肢部件应用于人体中仍然有时会产生问题。可能会有妨碍内置式假肢部件融入人体的微型有机体附着在内置式假肢部件的表面上。内置式假肢部件表面上存在微型有机体的危险性越大，以及内置式假肢部件与人体组织的接触面越大，将内置式假肢部件植入人体所须进行的手术就越大。必须进行大量手术以及内置式假肢大面积与人体组织接触的手术例如会用于头-颈假肢颈以及大腿骨完全被假肢替代的假肢。 
由WO 03/094774已知，为了起到抗菌作用，将由金属或一金属合金构成的植入物的表面氧化，并且为生成的硬材料层配备银粒子。由于硬材料层只能非常缓慢地与周围的人体组织反应，所以银粒子在这段时间内将从硬材料层上脱落。这种硬材料层也可保持长时间有效。在刚刚装入植入物之后，植入物周围可能还存在较大数量的微型有机体。而从硬材料层上脱落的银粒子剂量并不足以对较大数量的微型有机体产生有效作用。 
发明内容
本发明的目的在于，提供一种开篇所述类型的内置式假肢部件以及一种制备所述内置式假肢部件的方法，从而避免微型有机体妨碍内置式假肢部件融入人体。本发明的目的通过下述特征而达成：一种内置式假肢部件，其具有一设定内置式假肢部件形状的物体，具有一外层的所述物体布置在内置式假肢部件在植入状态下与人体组织接触的表面部分上，所述外层含有基于一难熔金属的氮化物、氧氮化物或氧化物，其中，所述外层中还含有银和/或铜，一中间层布置在所述外层与物体之间，可从外部接触所述中间层部分。根据本发明的内置式假肢部件的特征在于，在外层与物体之间设置一中间层，可以从外部触及中间层部分。 
首先要对一些概念进行解释。设定内置式假肢部件形状的物体至少在接触人体组织的内置式假肢部件的表面区域中区别于内置假肢部件之处在于：表面上额外涂有涂层。 
内置式假肢部件通常无需全部表面均与人体组织相连。内置式假肢部件可以在其表面上具有用于例如与另一内置式假肢部件配合作用的区域，从而形成一个关节。在本发明的范围内并不要求与人体组织接触的表面的所有区域均涂有一外层或一中间层。只要这些区域的部分表面涂有一外层和/或一中间层即可。 
与周围环境直接接触的层被称为外层。外层不会再被其它层覆盖。外层无须是全面涂覆，外层也可以有穿孔或者仅采取小岛状的涂覆方式。 
中间层的至少部分表面被外层覆盖。在不涂覆外层或外层有穿孔的区域中，中间层可直接与周围环境接触。中间层是部分地可从外部触及的。可直接从外部触及的中间层位置与不能直接从外部触及的中间层位置在内置式假肢部件的表面上交替出现。中间层的材料不同于制成内置式假肢部件的材料。 
人体组织这个概念应该从广义上去理解。它包括人体的内置式假肢件可以接触的所有人体中的元素，例如也包括骨骼。 
难熔金属为第四、第五及第六子群中的难熔金属、贱金属。包括第四子群中的钛、锆和铪，第五子群中的钒、铌和钽，以及第六子群中的铬、钼和钨。尤其适合于涂覆内置式假肢部件的难熔金属为钛、锆、铌和钽。将难熔金属离子与作为反应气体的氧气和/或氮气形成的化合物被称为基于一难熔金属的氮化物、氧氮化物或氧化物。这些化合物的特征在于硬度高，因此其形成的层被称为硬材料层。 
如果外层还含有银和/或铜，那么在生成氮化物、氧氮化物或氧化物时不仅有难熔金属离子和一反应气体参与，还有银离子和/铜离子参与。银离子和/或铜离子融合在生成的覆层中。外层因为含有银和/或铜而具有长效的抗菌作用。抗菌作用可以实现例如高硬度和高耐磨强度等良好的机械性能。 
由于在物体与外层之间设置了一个部分可从外部触及的中间层，所以除硬材料涂层长效的抗菌作用以外，内置式假肢部件的表面还可以具有其他作用。因此，中间层例如可以设计为，中间层在短时间内释放出较大剂量的抗菌剂。较大剂量的抗菌剂可以在手术结束后防止感染。 
设定内置式假肢部件形状的物体可由金属或一金属合金制成。尤其适合的材料为钛和钛合金。外层的概念也包括一个经多次涂覆工序而形成的涂层。如果在一次涂覆工序中所形成的涂层过薄，则尤其需要通过多次涂覆工序来完成涂层的涂装。 
中间层可以由银、铜和/或金构成。中间层优选为全面积涂覆。与外层的硬材料相比，这种中间层在与人体组织接触时受侵蚀的速度明显更快。因此可以释放出较大剂量的抗菌粒子。 
在可以从外部触及中间层的区域中外层是被穿通的。穿孔的直径可以为几μm或明显大于几μm。对于最小直径仅为几μm的穿孔，称之为多孔外层。如果微型穿孔直径例如在mm范围内，就可以大面积地从外部触及中间层。尤其可将外层设计为，穿孔面积占至少20％，优选为至少40％，更为优选为60％。 
如果外层的微结构或纳米结构具有突出的尖端，就可以增强抗菌作用。表面结构中突出的尖端所指的构造为，源自表面的所有方向上的尖端在相对于表面方向的倾斜角大于45°。与平滑的表面相比，可导电的尖端可为环绕其周边形成强大的电场，从而对微型有机体施加负面作用。 
本发明还涉及一种制备这种内置式假肢部件的方法。为了制备内置式假肢部件首先要准备一个设定内置式假肢部件形状的物体。所述物体上用于与人体组织相连的表面部分具有一涂层，所述涂层此时虽然仍未被一个外层所覆盖，但仍简单起见将其称为中间层。对中间层的表面结构没有特别的要求。表面可以为光滑或者具有宏观结构、微型结构或纳米结构。 
还要准备可以从中析出组成涂层所需的材料的目标物。可以准备既含有难熔金属又含有银和/或铜的单一的目标物。也可以准备多个目标物，其中，一第一目标物含有难熔金属，而一第二目标物含有银和/或铜。 
从一或多个目标物中析出难熔金属离子以及银和/或铜离子。为了析出离子，可以例如在一电极与目标物之间生成一电弧，电弧向目标物局部有限制地(仅使离子可以析出)供能。也可以使用激光照射目标物而向目标物局部提供足够多的能量。另一种成本昂贵的替代方案为，通过电磁辐射来输送能量。 
借助反应气体将自由的离子引导至物体被中间层所覆盖的表面部分上，形成了外层，可穿过此外层接触中间层。可以在目标物与物体之间设置一电压，此电压可在物体方向上使离子加速。装有目标物和物体的反应容器内含有反应气体，例如为氧气或氮气或氧气与氮气的混合物。难熔金属离子以及银和/或铜离子与反应气体反应而形成含有这三种组成部分的分子。在一实施形式中形成Ti-AgN分子。这种在物体表面进行的反应生成了按照本发明的外层。反应可以在真空下进行，优选在高真空下进行。这种类型的方法可以参见等离子涂层法。如果物体表面事先经过喷砂处理，所涂覆的涂层就会更加牢固。 
另一种可行方案为，外层采取可保证中间层可从外部接触的设计。例如可以生成一个具有微型穿孔的多孔外层，其方式为，对单个或多个目标物输送能量使除离子之外还有最大直径大于20μm的碎片从目标物中脱出。碎片向各个方向移动，从而会撞击到在物体表面形成的外层。所形成的外层在被碎片撞击的位置会有小块脱落。这就形成了多孔外层，可以从外部穿过所述多孔外层触及中间层。 
另一种保证中间层的可接触性的可行方案为，在物体待涂覆的表面部分上设置一个由热稳定材料制成的护具。所述护具覆盖部分表面，而表面的其它部分则外露。这 种护具可以例如为网状或栅栏状。这样仅会在没有被护具覆盖的位置上形成小岛状的外层。移除热稳定材料之后，就可以在相应的位置从外部接触中间层。热稳定材料应定义为在等离子涂层法的条件下仍保持稳定的材料。热稳定材料尤其可为一金属。 
如果选用恰当的等离子涂层法参数，就可以形成微型结构或纳米结构上具有突出的尖端的外层。如果中间层为银、铜和/或金，同样可以借助等离子涂层法来进行涂装。也可以借助电化学分离来将中间层涂覆至物体上。 
附图说明
下面按照附图借助本发明的一个优选实施形式来对本发明进行进一步说明，其中： 
图1为一个具有多个内置式假肢部件的内置式假肢； 
图2为一个根据本发明的内置式假肢部件； 
图3为图2的横截面图的部分放大视图； 
图4为本发明的另一实施形式中如图3的视图； 
图5为本发明的又一实施形式中如图3的视图；以及 
图6为本发明的一实施形式中图2中的内置式假肢部件表面的部分放大视图。 
具体实施方式
图1所示的内置式假肢是用于替代人体骨骼中从髋部延伸至膝盖下方的部分。一球形关节头10构成一个用于与髋臼配合作用的关节面。关节头10通过一螺栓连接与内置式假肢的顶端11相连。替代大腿骨中干的内置式假肢部分具有三个内置式假肢部件12，13，14。内置式假肢部件12，13，14相互之间以及与顶端11之间均为螺栓连接。用于连接小腿骨的杆16通过一铰链连接与弯头15相连。 
内置式假肢部件12，13，14可以选用不同的长度，这样内置式假肢将可以适配于不同的长度的大腿骨。图2显示了一个相应于内置式假肢部件12，13，14的内置 式假肢部件17的放大视图。内置式假肢部件17具有一螺栓18以及一用虚线表示的螺栓钻孔19。通过螺栓18以及螺栓钻孔19，内置式假肢部件17可以在上下两端与相同类型的内置式假肢部件相连，例如内置式假肢部件12，13，14。螺栓18、螺栓钻孔19以及邻接的端面20和21构成了内置式假肢部件17表面中用于与其他内置式假肢部件配合作用的部分。而内置式假肢部件17的侧面22则用于在植入状态下与人体组织接触。 
设定内置式假肢部件17形状的物体23位于侧面22的区域中，其具有一中间层24和一外层25。由银构成的中间层24在侧面22区域中覆盖物体23。覆盖中间层24的外层25为通过等离子涂层法涂覆的硬材料涂层，由钛、氮及银构成。 
在图4所示的实施例中，外层25为多孔的。中间层24从而可以穿过外层25中的微小穿孔对周围的组织发生抗菌作用。 
图6显示的是内置式假肢部件17的侧面22的俯视放大图。外层25仅呈小岛状覆盖中间层24。外层25同样具有微型穿孔，周围的组织可以通过这些穿孔与中间层24直接接触。中间层24被外层25涂覆的区域内，中间层24也可如图3所示一样气密，周围的组织与中间层24之间从而无法形成直接接触。 
图5所示的外层25的纳米结构上具有突出的尖端26。可导电的尖端形成一个环绕尖端26的电场，此电场可增强外层25的抗菌作用。图5中没有显示中间层。 

Claims (14)

1.一种内置式假肢部件，其具有一设定内置式假肢部件(17)形状的物体(23)，具有一外层(25)的所述物体(23)布置在内置式假肢部件在植入状态下与人体组织接触的表面部分(22)上，所述外层(25)含有基于一难熔金属的氮化物、氧氮化物或氧化物，其中，所述外层(25)中还含有银和/或铜，其特征在于，一中间层(24)布置在所述外层(25)与物体(23)之间，可从外部接触所述中间层(24)部分。
2.根据权利要求1所述的内置式假肢部件，其特征在于，所述中间层(24)由银、铜和/或金构成。
3.根据权利要求1或2所述的内置式假肢部件，其特征在于，所述外层(25)穿孔，穿孔面积比例占至少20％。
4.根据权利要求1或2所述的内置式假肢部件，其特征在于，所述外层(25)穿孔，穿孔面积比例占至少40％。
5.根据权利要求1或2所述的内置式假肢部件，其特征在于，所述外层(25)穿孔，穿孔面积比例占至少60％。
6.根据权利要求1或2所述的内置式假肢部件，其特征在于，所述外层(25)为多孔的。
7.根据权利要求1或2所述的内置式假肢部件，其特征在于，所述外层(25)在微型结构或纳米结构上具有突出的尖端(26)。
8.一种用于制备内置式假肢部件(17)的方法，具有以下步骤：
a.准备一个设定内置式假肢部件形状的物体(23)，其中，所述物体(23)上用于与人体组织相连的表面部分(22)具有一中间层(24)；
b.准备一难熔金属及银和/或铜，其形式为一或多个目标物；
c.从一或多个目标物中析出难熔金属离子以及银和/或铜离子；
d.将离子与一反应气体共同引导至覆盖着中间层(24)的物体(23)的表面部分(22)上，从而形成一外层(25)，可以穿过所述外层(25)接触中间层(24)。
9.根据权利要求8所述的方法，其特征在于，借助电弧从一或多个目标物中析出离子。
10.根据权利要求8所述的方法，其特征在于，借助激光从一或多个目标物中析出离子。
11.根据权利要求8所述的方法，其特征在于，借助电磁辐射从一或多个目标物中析出离子。
12.根据权利要求8至10中任一项权利要求所述的方法，其特征在于，在步骤a)中准备一个物体(23)，所述物体(23)的中间层(24)由银、金和/或铜构成。
13.根据权利要求8至10中任一项权利要求所述的方法，其特征在于，在步骤c)中额外有直径大于20μm的碎片从目标物中脱落，所述碎片在步骤d)中被引导至物体(23)上。
14.根据权利要求8至10中任一项权利要求所述的方法，其特征在于，在步骤d)之前使用一由热稳定材料制成的护具覆盖在待涂覆的物体的表面部分上。
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CN101801315A (zh) 2010-08-11
ATE506032T1 (de) 2011-05-15

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