CN102512268B - 包含无菌接合面的髋臼 - Google Patents

包含无菌接合面的髋臼 Download PDF

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Publication number
CN102512268B
CN102512268B CN201110303378.5A CN201110303378A CN102512268B CN 102512268 B CN102512268 B CN 102512268B CN 201110303378 A CN201110303378 A CN 201110303378A CN 102512268 B CN102512268 B CN 102512268B
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unit
plug
shell
lay
directed
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CN102512268A (zh
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托马斯·格拉德尔
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    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
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Abstract

本发明涉及一种髋臼，包括：金属的插入壳，该插入壳具有基本为半球形的凸形外部锚固面以及凹形接收面，该凸形外部锚固面形成为锚固在患者的骨盆的髋臼腔中。所述髋臼还包括陶瓷固定式最终关节插件，它具有外部表面和内部接收面，该外部表面接合在插入壳的凹形接收面中，该内部接收面包括基本为半球形的凹形关节表面，以便能接合假体股骨头或移动式关节插件，并使该假体股骨头或移动式关节插件枢转。该髋臼以无菌的组装状态被包装，其中陶瓷固定式最终关节插件接合在具有周向接收结构的插入壳中，该周向接收结构可接收用于固定冲击器以便安放髋臼的装置，并设计成使得该冲击器可在陶瓷固定式最终关节插件的存在的情况下被固定到该髋臼。

Description

包含无菌接合面的髋臼
本申请是申请日为2008年1月8日、名称为“包含无菌接合面的髋臼”的专利申请200880001880.7的分案申请。
技术领域
本发明涉及一种假体髋臼，该假体髋臼用于置换髋部的自然髋臼。
背景技术
全髋部假体包括构成球关节的两部分，即凹形部分和凸形部分，所述凹形部分用于置换髋部的自然髋臼，而凸形部分用于置换股骨的头部。
关节的凸形部分一般包括一杆，该杆用于深入到股骨的骨髓管中，杆的近端通过颈状部连接到球头上，该球头用于伸入到髋臼中。
关节的凹形部分必须置换髋部的自然髋臼并且总体称之为髋臼，它通常包括半球形的插入壳，该插入壳容纳在制备于骨盆的骨中的髋臼腔中，并且在该插入壳中容纳有最终关节插件。插入壳按常规由金属制成。
关节插件由具有低摩擦系数的材料例如聚乙烯或陶瓷制成。
在单动式髋臼中，聚乙烯或陶瓷插件被固定到插入壳中，并包括一同轴且基本为半球形的关节腔，在该关节腔中，该髋臼接合关节的凸形部分的球头并使之枢转。然后在凸形假体部分的球头和插件的关节腔之间产生关节的旋转运动。
当将插入壳放置在髋臼腔中时，必须能使用冲击器来保持和操纵该插入壳，并能对它施加力以便在良好方位情况下将它钉在骨的髋臼腔中一段时间，该段时间尤其足够使粘合剂在插入壳的外表面和骨的髋臼腔之间固定。
在单动式髋臼中，冲击器一般包括螺纹端部分，该螺纹端部分固定到设置于插入壳的中心处的螺孔中。
当使用髋假体时存在的主要问题是脱位的危险，即，球形股骨头从关节腔离开。
为了减少脱位的危险，提出了双动式髋臼结构，在该结构中插入壳是金属，并接收聚乙烯关节插件，所述关节插件自身旋转式安装在插入壳中。这种结构的缺点是存在关节插件的逐渐磨损，这种逐渐磨损使得关节不稳定并且存在使用几年之后脱位的危险。
另一种用于防止脱位的有效手段是，在单动式髋臼中使用较大直径的球形假体股骨头。为了使股骨头离开关节腔，股骨头必须脱出达到基本等于股骨头的半径的距离。因此，假体股骨头的直径越大，则发生假体脱位所需的力也越大。
然而，患者的髋臼腔具有固定的尺寸，该尺寸非常难以(或者根本不能)修改。因而固定的关节插件的必要厚度决定假体股骨头的可能直径。因此，已经设想使用薄的固定式关节插件，以便能增加假体股骨头的直径。为了进一步减小固定式关节插件的厚度以有利于股骨头的直径，并且同时减小磨损的危险，已经设想带有金属插入壳的插件和陶瓷插件，陶瓷具有比聚乙烯好的低摩擦性能和大机械强度。陶瓷的较大的机械强度使它即使在很薄时也能承受关节中的机械应力。在现代化陶瓷情况下，固定式关节插件可以使用约4mm或更小的厚度。专利文献EP 1290992A1中描述了一种这样的陶瓷插件髋臼。
为了进一步增加假体股骨头的直径，上述文献教导用同样厚度的陶瓷固定式插件来减小插入壳的厚度。因此，金属壳具有0.1-2mm的厚度，而陶瓷插件具有小于4mm的厚度。
然而，在冲击髋臼以将它安放期间，或者甚至在随后的使用假体期间，都观察到陶瓷插件断裂的危险大大增加。
按照本发明，可以认为，这种断裂是由机械力在陶瓷插件上的不均匀分布引起的，同时应注意，专利文献EP 1290992A1未涉及这些问题，并且没有说明正确冲击髋臼的手段。
发明内容
本发明所致力的问题是减少髋部假体的脱位的危险，同时减少陶瓷插件在被冲击到患者的骨盆的髋臼腔中期间以及随后的假体使用期间断裂的危险。
为了达到上述和其它的目的，本发明提出一种髋臼，该髋臼包括：
-金属的插入壳，该插入壳具有一基本为半球形的凸形外部锚固面和一凹形接收面，该外部锚固面设计成(使该外部锚固面适合，conform)能锚固在患者的骨盆中的髋臼腔中，该凹形接收面具有环形边缘，
-陶瓷的固定式最终关节插件，该关节插件具有外部表面和内部接收面，该外部表面接合在插入壳的凹形接收面中，该内部接收面包括基本为半球形的凹形关节面，以便能接合假体股骨头和移动式关节插件并使它们枢转，
-陶瓷固定式最终关节插件的厚度为小于或等于约4mm，
-该插入壳包括一环形接收结构，该环形接收结构伸出到插入在插入壳中的固定式最终关节插件的接收面的外面，并包括环形接收面，该环形接收面设计成(使该环形接收面适合)能在陶瓷固定式最终关节插件存在的情况下在所述环形接收面上固定冲击器，
-插入壳在其环形边缘附近具有小于或等于4mm并且大于2mm的厚度。
由于插入壳和关节插件的厚度小，所以可为股骨头和凹形关节表面提供最大尺寸，以便有效地减少在随后的使用期间关节脱位的危险。同时，尽管(具有)这些小厚度，但环形接收结构仍能不仅在髋臼被冲击器冲击期间有效保持该髋臼，而且当在冲击之前装配时还提供插入壳和关节插件之间的有效配合。由于陶瓷关节插件保持与插入壳接触并吸收一部分力，所以这种配合减少了插入壳在冲击期间变形的危险。这种配合还减少了冲击期间关节插件断裂的危险，冲击力加到插入壳上，此后该插入壳用分布在陶瓷关节插件上的方式传送冲击力。在冲击之后，这种配合也减少了关节插件随后断裂的危险，因为机械力用有规律的和分布的方式在关节插件和没有变形的插入壳之间传输。
在安放期间，插入壳保持附接到固定式最终关节插件。因此，这两个部分之间的界面保持不可接近和无菌，同时在手术期间没有污染的危险。
由于周向接收结构伸出到插在插入壳中的固定式最终关节插件的外面，以及由于插入壳在环形边缘的附近-即在构成周向接收结构的区域中-的足够厚度，所以尽管固定式最终关节插件防止接近设置在插入壳的中心处的任何螺纹孔，但可靠地将冲击器固定到插入壳上也是可行的。
此外，在使用假体的极端位置中，承载假体股骨头的假体颈状部压靠在伸出的周向接收结构上。这样，假体颈状部不抵靠陶瓷固定式最终插件，并因此没有因局部点负荷的施加而损坏该插件的危险。
环形接收面优选地从插入壳的凹形接收面延伸并与其连接，因此是插入壳的内部表面的环形部分。这种周向接收结构是紧凑的，且容易用普通生产设备生产。这种周向接收结构还与插入壳成一个部件，并因此可靠地使外科医生能施加必要的力，以用于假体的良好固定和良好定向。
髋臼有利地可以与安放及定向插件相关联(相互作用)，该安放及定向插件可拆卸(可移动地)地固定到插入壳的周向接收结构上并包括一种装配结构，冲击器可以可拆卸地固定到该装配结构上。这种固定到插入壳的周缘的插件可在该壳上很好地分布由外科医生所施加的用以固定和定向假体的力。
按照本发明的另一有利方面，髋臼以无菌装配状态被包装，其中陶瓷固定式最终关节插件接合在插入壳中，安放及定向插件固定在插入壳上。
这种组合的一个好处是在运输和操纵期间安放及定向插件将陶瓷关节插件保持在插入壳中。因此能提供一种关节插件，该关节插件简单地接合在插入壳中，然后如果外科医生需要可以将关节插件从插入壳中取出，而没有在安放髋臼之前将其意外取出的危险。这种组合可以独立地使用关节插件和插入壳的厚度特点。
为了进一步强化关节插件，固定到插入壳的环形接收面上的安放及定向插件可以压在陶瓷固定式最终关节插件的内部接收面上或者与该内部接收面相距一小的距离。
替代性地或者附加地，固定到环形接收面上的安放及定向插件可以包括一个或多个伸出的弹性肋，该弹性肋适于压在陶瓷固定式最终关节插件上，以便将该陶瓷固定式最终关节插件保持在插入壳中。
陶瓷固定式最终关节插件可由聚乙烯制成，聚乙烯是容易消毒并且可用在手术环境中的低成本材料。
装配结构优选地可以包括带螺纹的固定孔，该固定孔形成在安放及定向插件中，可以允许冲击器的对应带螺纹部分拧入其中。这可生产简单、可靠而价廉的装配结构，以允许使用众所周知且容易获得的冲击器。
按照本发明的第一有利实施例：
-周向接收结构可以包括连续的或不连续的环形槽，
-安放及定向插件可以包括连续的或不连续的环形肋，该环形肋弹性地接合在环形槽中。
按照本发明的第二有利实施例：
-周向接收结构可以包括内螺纹或外螺纹，
-安放及定向插件可以包括外螺纹或内螺纹，该外螺纹或内螺纹与周向接收结构的螺纹配合，以便通过将该安放及定向插件拧入周向接收结构中而可拆卸地固定安放及定向插件。
因此，各种周向接收结构和安放及定向插件可被容易且低成本地生产，并提供足够的强度，以使外科医生能施加用于良好地固定且良好地定向假体所必须的力。
在本发明的第一实施例中，带螺纹的固定孔可有利地为开放的孔，其适于与包括螺纹杆的拆卸工具配合，该螺纹杆适于拧到该固定孔中并具有一远端，该远端设计成(使该远端适合)在将螺纹杆拧到安放及定向插件的固定孔中期间压在固定式最终关节插件的凹形关节面上。
可供选择地，在本发明的第一实施例中，可有利地包括：
-安放及定向插件可设计成(可使安放及定向插件适合)，使得在将安放及定向插件固定到插入壳的周向接收结构上后，在安放及定向插件与固定式最终关节插件的凹形关节面的底部之间仍有自由空间，
-安放及定向插件可以在其周缘与插入壳的短的环形延伸部分密封地接触，
-固定孔可以是开放的孔，该孔提供外部和自由空间之间的连接-所述自由空间位于安放及定向插件与固定式最终关节插件之间，并且该孔的尺寸设计成使得在其内可以密封地接合注射器的端部。
本发明的另一方面提出一种生产假体髋部髋臼的方法，该方法包括以下步骤：
a)提供金属的插入壳，该插入壳具有凹形接收面和伸出的环形接收结构，
b)提供陶瓷的关节插件，该关节插件具有外部表面和凹形关节表面，
c)将关节插件的外部表面接合在插入壳的凹形接收面中，
d)在微生物防护套中对由此形成的组合进行消毒(灭菌)。
该方法的优点是即使假体更无菌-特别是在关节插件和插入壳的接合面处，同时又能使用简单地可拆卸地接合在插入壳中的关节插件。
消毒可以在装配关节插件和插入壳之后通过用γ射线轰击实施。这种消毒过程适合所用的材料，即插入壳的金属和关节插件的陶瓷。
该方法有利地还可以在消毒之前包括将安放及定向插件固定到插入壳上的附加步骤c1)。
这种方法，无论是否包括固定安放及定向插件的步骤，可以与是否存在关节插件和插入壳的特定厚度特点无关地使用。
本发明的另一方面还提出这种方法，该方法包括随后的步骤：
e)在手术室中打开密封的防护套，
f)将冲击器固定到髋臼上，
g)将髋臼接合在骨内的髋臼腔中，并冲击髋臼以将其固定到骨上。
附图说明
本发明的其它目的、特点和优点从下面参照附图给出的具体实施例的说明中示出，在附图中：
-图1是本发明的髋臼具有安放及定向插件的部件分解图；
-图2是插入壳的侧视图；
-图3是图1的元件的剖视图；
-图4是图1的元件在装配之后的剖视图；
-图5是固定到冲击器上的本发明的髋臼的局部剖视图；
-图6是图5的细部的视图；
-图7和图8是示出拆卸安放及定向插件的第一种方法的剖视图；
-图9是示出拆卸安放及定向插件的第二种方法的剖视图；
-图10是示出一种髋臼的安放及定向插件，它还包括用于保持关节插件的弹性肋。
具体实施方式
在图1、3和4中，示出了单动式或双动式髋臼。双动式髋臼包括：
-插入壳1，该插入壳1具有一基本上是半球形的凸形外部锚固面2以及一凹形接收面3，所述凸形外部锚固面2适于锚固在患者的骨盆内的髋臼腔中，
-陶瓷的固定式最终关节插件4，该插件4具有外部表面5和内部接收面6，所述外部表面5接合在插入壳1的凹形接收面3中，而上述内部接收面6包括一基本上是半球形的凹形关节表面7，以便能接合假体股骨头或移动关节插件(未示出)并使其枢转。
最终关节插件4被叫做固定式最终关节插件是因为它相对于插入壳1固定。
在图1、3和4中，插入壳1包括锚固翼27，该锚固翼27用于伸入患者的髋臼腔的骨中，以保证良好地锚固到插入壳1。
图1和图3分别是用透视图和剖视图示出的部件分解图，而图4是图1和3中的元件当装配在一起时的剖视图。
在图4的构型中，髋臼以无菌装配状态被包装，其中陶瓷的固定式最终关节插件4接合在插入壳1中。插入壳1包括一周向接收结构8，该接收结构8适合于接收用于固定髋臼安放冲击器的装置，并且成形为使得能用接合在插入壳1中的陶瓷固定式最终关节插件4将冲击器固定到髋臼上。
陶瓷的固定式最终关节插件4具有一小的厚度E’，以便能使用大直径的假体股骨头。
为了表征关节插件的厚度，一般考虑它在与其凹形关节表面垂直的不同方向上的平均厚度。当关节插件具有平的底部时，如在图1、3和4的固定式最终关节插件4那样，该底部的厚度一般用于确定该插件的平均厚度。
因此，固定式最终关节插件4的厚度基本等于在图3、4和6-8中示出的厚度E’。
为了有效地减少脱位的危险，选择小的厚度E’以便增加假体股骨头(未示出)的直径或者能使用移动式关节插件(未示出)，上述假体股骨头用于插入固定式最终关节插件4的凹形关节表面7中(在专利文献EP1290992A1所述类型的单动式髋臼的情况下)，而上述移动式关节插件用于接收假体股骨头(如专利文献WO 2004/069091中所述类型的双动式髋臼的情况那样)。
厚度E’如此选择，以便固定式最终关节插件4可以承受患者在正常使用髋假体期间所产生的应力，而没有过早磨损或退化变质。
所谓小的厚度E’是指厚度E’小于或等于约4mm，优选地小于或等3.5mm。可将如专利文献EP 1188729中所描述的陶瓷用于这个目的。
为了表征插入壳的厚度，一般考虑它在其凹形接收表面的上边缘附近的厚度。因此，插入壳1的厚度基本上等于在图3和6-9中示出的厚度E。该厚度E是插入壳1在插入壳1的凹形接收表面3的环形边缘9附近的平均厚度。
为了进一步且有效地减少单动式或双动式髋臼脱位的危险，选择小的厚度E。所谓小的厚度E是指厚度E小于或等于约4mm，优选地小于或等于3mm，但大于2mm，以保证足够的机械强度。
从图4和8中可以更清楚地看出，插入壳1包括伸出到已插在插入壳1中的固定式最终关节插件4的接收面6的外面的周向接收结构8。
周向接收结构8构成插入壳1的壁的短环形延伸部分，其中，在本实施例中，一内部环形接收面10(在图4和8中用虚线示出)从插入壳1的凹形接收面3延伸并与其连续。
在图1-9的实施例中，为了能固定冲击器，设置一安放及定向插件11，该插件11可拆卸地固定到插入壳1的周向接收结构8上。因此，安放及定向插件11可以在接合于插入壳1中(图4，5，6，7和9)的陶瓷固定式最终关节插件4存在的情况下固定到插入壳1上，并可以在将髋臼冲击到患者的髋臼腔中之后与插入壳1分开(如图8中更好示出的)。
安放及定向插件11包括一装配结构12，冲击器可以可拆卸地固定到该装配结构上。在被固定到插入壳1的周边上之后，安放及定向插件11可将外科医生施加的力分布在插入壳1上，以便通过冲击器将假体固定和定向。
在图1-9所示的实施例中，装配结构12包括一形成在安放及定位插件11中的带螺纹的固定孔13。冲击器15的带螺纹部分14可拧入该带螺纹的固定孔13(图5和6)。因此，要将冲击器15从安放及定向插件11上拆下，将冲击器15的带螺纹部分14从带螺纹的固定孔13旋出就够了。
在图1-9所示的实施例中，周向接收结构8包括环形槽16，在该环形槽中接合有环形肋17，所述环形肋设置在安放及定向插件11上。当装配插入壳1、固定式最终关节插件4和安放及定向插件11时，环形肋17弹性地接合在环形槽16中，该装配过程在图3中用箭头30和31示意示出。
在图1-9所示的实施例中，环形槽16和环形肋17是连续的。环形槽16和环形肋17的连续的特点使得能在插入壳1中围绕该插入壳1的整个外周将安放及定向插件11均匀而最大程度地保持。
然而，可以设想环形肋17和环形槽16的其它形式。例如，环形槽16和环形肋17可以不连续。
同样，环形槽16和环形肋17在安放及定向插件11或插入壳1上的布局可以与图1-9所示的布局不同。
在图1-9中，环形槽16设置在插入壳1的周向接收结构8的环形内部接收面10上，而安放及定向插件11的环形肋17是弹性接合在环形槽16中的外部环形肋17。安放及定向插件11未在侧向上伸出到插入壳1的周缘的外面。因此，在髋臼的冲击和定向期间，在它们的髋臼腔的周缘，安放及定向插件11与患者的骨盆的骨材料之间没有冲突的危险。
在未在图1-9中示出的本发明的另一实施例中，周向接收结构8和安放及定向插件11包括相互配合的螺纹，以便通过将安放及定向插件11拧到周向接收结构8上来可拆卸地固定安放及定向插件11。当安放及定向插件11的螺纹是外螺纹时，周向接收结构8的螺纹是内螺纹；而当安放及定向插件11的螺纹是内螺纹时，周向接收结构8的螺纹是外螺纹。
在使用时，髋臼以无菌装配状态被包装，其中陶瓷的固定式最终关节插件4接合在插入壳1中(图4)。为将插入壳1放置在髋臼腔中，外科医生使用冲击器15，该冲击器15具有带螺纹的端部部分14，该部分固定到形成在安放及定向插件11中的带螺纹的固定孔13中(图5和6)。
冲击器15包括凸缘26，该凸缘压在安放及定向插件11的上表面28上。凸缘26将冲击和定向力分布在安放及定向插件11上。
外科医生利用冲击器15来施加力以便将插入壳1钉到骨的髋臼腔中，施加转动力矩以调节插入壳1的方位，并且将插入壳1保持在固定位置中一段时间，该段时间尤其足够粘合剂在插入壳1的外表面和骨中的髋臼腔之间固结。
在这些操作期间，插入壳1受到很大的力，由于小的厚度E(图6)，所以该力可能使插入壳1在单独与患者的骨盆的骨接触时变形。在冲击插入壳1期间，插入壳1的这种变形可以通过接合于插入壳1中的固定式最终关节插件4的存在而被阻止。
因此，即使患者的骨盆的骨容由于插入壳1的小厚度E而易于使该插入壳1变形，陶瓷固定式最终关节插件4也足够坚固而抵销这种变形。陶瓷固定式最终关节插件4加强了插入壳1。
插入壳1、固定式最终关节插件4以及安放及定向插件11有利地可以在无菌状态下包装在一起。然后外科医生可以一次操作用它的固定式最终关节插件4冲击插入壳1。这样节省了外科医生宝贵的手术时间，从而有助于减少与可能的感染相关的手术风险。
在已经冲击装配有固定式最终关节插件4的插入壳1之后，外科医生将安放及定向插件11从插入壳1的周向接收结构8中拆下，并将选定的假体股骨头放到固定式最终关节插件4的凹形关节表面7中。
从插入壳1中拆卸安放及定向插件11的步骤更具体地在图7-9中示出。
拆卸安放及定向插件11的第一种方法在图7和8中示出。
在图7和8中，开放的带螺纹的固定孔13能与包括螺纹杆19的拆卸工具18接合，该螺纹杆19适于拧到该固定孔13中。拆卸工具18具有远端20，该远端20适合当将螺纹杆19拧到安放及定向插件11的固定孔13中时压在固定式最终关节插件4的凹形关节表面7上。
当安放及定向插件11的环形助17已弹性地从环形槽16离开时，将螺纹杆19拧到固定孔13中(视所用的螺纹的构造而定用种种方法转动该螺纹杆)，使安放及定向插件11沿轴向方向I-I移动离开插入壳11，直至该安放及定向插件被完全拆开(图8)。
拆卸工具18的远端20适于压在固定式最终关节插件4的凹形关节表面7上而不损坏它。
拆卸安放及定向插件11的第二种方法在图9中示出。
在该图9中，安放及定向插件11的形状设计成，使得在该安放及定向插件11已经被固定到插入壳1的周向接收结构8上后，在安放及定向插件11和固定式最终关节插件4的凹形关节表面7的底部之间仍有自由空间S。安放及定向插件11在插入壳1的短的环形延伸部分9中沿着它的周缘进行密封接触。
固定孔13的开发的特点提供外部与形成在安放及定向插件11与固定的最终关节插件4之间的自由空间S之间的连通。
固定孔13的尺寸设计成能与一加压流体进料管21的端部接合。
该管21将流体从外部送到自由空间S中，如箭头22所示。然后流体充满自由空间S，并且管21中和自由空间S中的流体压力沿着轴线I-I在安放及定向插件11上沿箭头32所限定的方向产生推力。在足够的流体压力和该压力可施加于其上的安放及定向插件11的足够面积的情况下，可通过使环形肋17离开环形槽16而将安放及定向插件11快速而方便地从插入壳1中抽出。
实际上，已经通过使用注射器而得到了良好的结果。流体进料管21因而可以是注射器的端部。使用注射器在医学方面是特别有益的。这是可以消毒并且容易在手术室中使用的常规医用物体。可供选择地，流体进料管21可以是冲击器自身的管状部分。
用来使插入壳1与安放及定向插件11分开的流体可以是水或生理血清，可以使用并在手术室中很广泛地使用的流体。
实际上，已经通过使用聚乙烯安放及定向插件11得到了良好的结果。聚乙烯是可以在手术室中使用、便于消毒并且成本低的材料。
在图6中，可以看出，安放及定向插件11被固定在插入壳1的周向接收结构8上，并与陶瓷固定式最终关节插件4的内部接收面6相距小的距离e。该距离e能可靠而牢固地将环形肋17围绕环形槽16的整个周缘接合在环形槽16中。此外，在将髋臼冲击到患者的骨盆的髋臼腔中期间，轴向冲击力将使安放及定向插件11沿轴线I-I很轻微地变形，从而距陶瓷固定式最后插件4的内部接收面6或其周向边缘的距离更短或甚至压在其上。
如果聚乙烯安放及定向插件11变成压在陶瓷固定式最终关节插件4的内部接收面6或其周向边缘上，则固定式最终关节插件4传送冲击和定向髋臼的力。固定式最终关节插件4还保持压靠插入壳1的凹形接收面3，这确保该固定式最终关节插件4有助于插入壳1的刚度并防止其变形。
如果在冲击髋臼期间在安放及定向插件11与陶瓷固定式最终关节插件4的内部接收面6之间仍有大的距离e，如图4和6-9中所示，则可在固定式最终关节插件4和插入壳1之间设置锥形配合23。因而可以确定，尽管存在距离e和由冲击引起的振动，固定式最终关节插件4仍然有助于插入壳1的刚度并防止该插入壳1变形，尤其是可能由于径向力而发生的变形，该径向力如箭头24所示，并由患者的骨盆的骨材料引起。
在图10所示的实施例中，安放及定向插件11具有伸出的弹性助11a，该弹性肋可弹性压靠陶瓷关节插件4，以保持它被压到插入壳1中。在所示的实施例中，弹性肋11a取环形唇边的形式，并压靠内部接收面6。或者，可以设置压靠陶瓷关节插件4的前周向边缘的弹性肋，或者可以设置多个弹性肋或其它弹性形状，以便同时压靠关节插件4。
显然，与通常已知的单动式髋臼相比，接合在插入壳1中的陶瓷固定式最终关节插件4的存在可省去对固定螺钉的使用，所述固定螺钉用于通过贯穿该插入壳从其凹形接收面到其凸形外部锚固面2的通孔而固定在患者的骨盆的髋臼腔中。
在这种情况下，在插入壳1的凸形外部锚固面2的上边缘附近设置图2所示的外部固定凸耳25可能是有利的。该外部固定凸耳25包括开口29，螺钉(未示出)通过该开口29以便锚固在患者的骨盆的骨中。
尽管只清楚地说明了少数几种把安放及定向插件11固定到插入壳1上的方法，但很显然，任何其它可供选择的固定方法都包括在本发明的保护范围内。例如，可通过强制插入安放及定向插件11而将该安放及定向插件11固定到插入壳1的周向接收结构8上。
插入壳1可以由金属例如钛或铬和钴合金钢制成。插入壳1同样可以由PEEK(聚醚醚酮)或任何其它合适的材料制成。插入壳1的外部凸形面2有利地可以覆盖有一层HAP(羟基磷灰石)。
实际中，已经通过接合厚度E小于或等于4mm的金属插入壳1中的、厚度E’小于或等于3.5mm的陶瓷固定式最终关节插件4实现了在冲击期间良好的抗脱位能力和良好的抗变形性。
本发明不限于上面已清楚地说明的实施例，而是包括下面权利要求书的范围内所包含的变型及其概括。

Claims (14)

1.生产体外假体髋部髋臼组件的方法，包括以下步骤：
a)提供金属的插入壳(1)，该插入壳具有凹形接收面(3)和周向接收结构(8)，
b)提供陶瓷的关节插件(4)，该陶瓷的关节插件与该插入壳是区别开的并且与该插入壳分开地制造，该陶瓷的关节插件具有外部表面(5)和内部接收面(6)，该内部接收面包括凹形关节表面(7)，
c)将该陶瓷的关节插件(4)的外部表面(5)接合在插入壳(1)的凹形接收面(3)中，
c1)在插入壳(1)上可拆卸地固定一安放及定向插件(11)，该安放及定向插件具有一装配结构(12)，冲击器(15)能可拆卸地固定到该装配结构上，
d)在微生物防护套中对由此形成的组件进行消毒。
2.按照权利要求1所述的方法，其特征在于，通过用γ射线轰击来实施消毒步骤d)。
3.按照权利要求1或2所述的方法，其特征在于，安放及定向插件(11)由聚乙烯制成。
4.按照权利要求1或2所述的方法，其特征在于，装配结构(12)包括带螺纹的固定孔(13)，该固定孔形成在安放及定向插件(11)中，使得冲击器(15)的对应的带螺纹部分(14)能被拧入。
5.按照权利要求1或2所述的方法，其特征在于，固定到插入壳(1)上的安放及定向插件(11)压在该陶瓷的关节插件(4)的内部接收面(6)上或者与该内部接收面(6)隔开一小的距离(e)。
6.按照权利要求1或2所述的方法，其特征在于，固定到插入壳(1)上的安放及定向插件(11)包括一个或多个伸出的弹性肋(11a)，所述弹性肋适于压在该陶瓷的关节插件(4)上，以便将该陶瓷的关节插件保持在插入壳(1)中。
7.按照权利要求1或2所述的方法，其特征在于，插入壳(1)在环形边缘(9)附近具有小于或等于4mm并且大于2mm的厚度(E)。
8.按照权利要求1或2所述的方法，其特征在于，该陶瓷的关节插件(4)具有小于或等于4mm的厚度(E’)。
9.按照权利要求1或2所述的方法，其特征在于，周向接收结构(8)为环形。
10.按照权利要求1或2所述的方法，其特征在于：
-周向接收结构(8)包括连续的或不连续的环形槽(16)，
-安放及定向插件(11)包括连续或不连续的环形肋(17)，所述环形肋弹性地接合在环形槽(16)中。
11.按照权利要求10所述的方法，其特征在于：
-环形槽(16)是连续的，
-安放及定向插件(11)的环形肋(17)是弹性地接合在环形槽(16)中的连续的外部环形肋(17)。
12.按照权利要求1或2所述的方法，其特征在于：
-周向接收结构(8)包括内螺纹或外螺纹，
-安放及定向插件(11)包括外螺纹或内螺纹，该螺纹与周向接收结构(8)的螺纹配合，以便通过将该安放及定向插件(11)旋拧到周向接收结构(8)上来可拆卸地固定该安放及定向插件。
13.按照权利要求4所述的方法，其特征在于，带螺纹的固定孔(13)是适于与拆卸工具(18)配合的开放的孔，该拆卸工具包括适于旋拧到该固定孔(13)中的螺纹杆(19)，该螺纹杆具有远端(20)，所述远端(20)设计成使得在将螺纹杆(19)拧到安放及定向插件(11)的固定孔(13)中期间压靠该陶瓷的关节插件(4)的凹形关节表面(7)。
14.按照权利要求4所述的方法，其特征在于：
-安放及定向插件(11)设计成，使得在将安放及定向插件(11)固定到插入壳(1)的周向接收结构(8)上后，在该安放及定向插件(11)与该陶瓷的关节插件(4)的凹形关节表面(7)的底部之间仍有自由空间(S)，
-安放及定向插件(11)在其周缘与插入壳(1)的周向接收结构(8)密封地接触，
-固定孔(13)是开放的孔，从而提供外部和处于安放及定向插件(11)与该陶瓷的关节插件(4)之间的自由空间(S)之间的连通，该固定孔的尺寸设计成在其内密封地接合加压流体管的端部。
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