CN101039638A - 用于安装髋臼杯的器械 - Google Patents

用于安装髋臼杯的器械 Download PDF

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CN101039638A
CN101039638A CNA2005800346530A CN200580034653A CN101039638A CN 101039638 A CN101039638 A CN 101039638A CN A2005800346530 A CNA2005800346530 A CN A2005800346530A CN 200580034653 A CN200580034653 A CN 200580034653A CN 101039638 A CN101039638 A CN 101039638A
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cup
jointer
shaped spare
assembly
impacter
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CN101039638B (zh
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托马斯·格拉德尔
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4609—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of acetabular cups
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Abstract

本发明涉及一种分别设计成沿周缘(7a)彼此紧密压配合的杯状件(1)和临时插入件(2)。该临时插入件(2)包括通过临时插入件(2)的外表面与杯状件的内表面之间的自由空间(9)与外部连通的通孔(10)。可将冲击器的带螺纹端部接合进该通孔(10)中，以便在安装杯状件时操作该杯状件(1)。可接合一注射器，从而能将加压液体注射入自由空间(9)中，由此使临时插入件(2)与杯状件(1)分离，而不会破坏该杯状件(1)的内表面。从而，在安装杯状件(1)时能安全地操作该杯状件，而不存在破坏该杯状件(1)的内表面的危险。

Description

用于安装髋臼杯的器械
技术领域
本发明涉及用于安装人造髋臼杯以替换髋部的先天髋臼杯的器械。
背景技术
整个髋部假体包括构成髌骨关节的两个部分，即将替换髋部的先天髋臼杯的凹部分和将替换股骨的头部的凸部分。
关节的凸部分通常包括将刺入股骨的髓管中的杆，并且其近中心端通过颈状部分连接到将刺入髋臼杯中的球形头部。
关节的必须替换髋部的先天髋臼杯并将整体称为髋臼杯的凹部分通常包括具有凸近端面和凹远端面的半球形金属杯状件，该凸近端面容纳在由盆骨制备的髋臼腔中，该凹远端面接纳用具有低摩擦系数的塑料材料例如聚乙烯或陶瓷制成的插入件的半球形凸近端面，该插入件本身具有同轴的半球形远端凹腔，该凹腔接纳关节凸部分的球形头部。
已提出单移动性假体，其中聚乙烯或陶瓷插入件固定在金属杯状件的凹远端面内，关节的旋转运动发生在假体的凸部分的球形头部和插入件的半球形远端凹腔之间。
还提出了双移动性假体，其中聚乙烯或陶瓷插入件本身能够在金属杯状件的凹远端面内旋转，从而关节的旋转运动一方面在插入件的凸近端面和金属杯的凹远端面之间发生，另一个方面在插入件的半球形远端凹腔和凸关节部分的球形头部之间发生。
在所有情况下，一个难题是将金属杯定位和固定在骨头的髋臼内。实际上，将杯状件装配和固定在髋臼内的质量对于假体的寿命—即对于骨头和金属杯状件之间的连接的耐久性—是非常重要的。
因此，当将杯状件安装在髋臼内时，必须能使用冲击器以施加力以将杯状件插入骨头的髋臼中、能施加转动力矩以用于调节杯状件的朝向并且尤其能将杯状件在固定位置保持足够长的时间以使杯状件的凸近端面和骨头的髋臼之间粘合。然后，必须能收回冲击器而不向杯状件施力，以便不损害杯状件固定在髋臼内的质量。
但是，尤其在双移动性假体的情况下—其中杯状件的凹远端面构成必须非常光滑的滑动面并且为此通常进行镜面抛光以使插入件能在杯状件内自由枢转，必须防止用于将杯状件安装进髋臼内的器械损害凹远端面的所有危险。例如，能够沿径向膨胀和收缩并且靠在杯状件的凹远端面的多个不连续区域上以在安装期间保持杯状件的器械必然会造成杯状件的凹入远端面的永久且局部的变形或者保持力不足，这种保持方式是不可接受的。
文献EP 0504521 A1提出一种具有凸近端面的冲击器，该凸近端面夹在杯状件的凹远端面内。在将杯状件固定在髋臼内之后，利用轴向滑杆将冲击器与杯状件分开，该滑杆沿轴向靠在杯状件的凸远端滑动面的中心上并且通过外科医生操作触发器而运动。滑杆的靠接接合会局部损害杯状件的滑动面，这是不可接受的。
文献FR 2809305 A1提出通过在头部和杯状件的凹远端面之间自由空间内产生真空而在冲击器的端部将杯状件保持在该头部上。为此，冲击器体部具有手动操作的活塞泵，该活塞泵用于经由贯穿头部的孔从自由空间中抽吸出空气。O形环阻止空气进入自由空间。头部向环绕自由空间的杯状件的凹远端面部分施加撞击力。该装置复杂、必然需要许多部件且带有许多气体密封装置，并且该文献未提到或解决由不平衡的支承应力导致的杯状件的凹远端面变形的问题。
已设想许多用于保持杯状件而不支靠其凹远端面的其它装置。第一种这样的装置主要利用其环形唇缘及其外表面的相邻部分保持杯状件。但是，这会在围绕杯状件的保持区域内局部恶化骨质，这会削弱杯状件随后在骨头内的保持力。
文献US 4632111 A说明了适用于固定底切杯状件的装置。冲击器包括安装在柄的端部且接合在杯状件的凹远端面内的半球形头部。环形凸缘安装成在该柄上滑动，并且被旋拧在该柄上的衬套朝头部推动。弹性环在该头部和凸缘之间沿轴向压缩且沿径向膨胀，从而靠在杯状件的凹远端面的环形底切部分上以固定冲击器。旋松衬套以收回凸缘，使弹性环缩回，然后收回冲击器。该装置复杂、包括含有大量部件的组件，并且不适于固定未被底切的杯状件。此外，旋拧操作会在杯状件上会导致不希望的力矩，这具有使在髋臼内的固定质量变差的危险。
文献DE 19628193 A说明了一种具有外围弹性环和接合在贯穿该杯状件的底部的孔内的定中心榫的冲击器头。这种穿孔的杯状件结构不适用于双移动性的假体。
因此，当前已知的杯状件安装器械不能在不损害杯状件或相邻的骨头的情况下为杯状件的自由定向以及其在骨头内的足够的支承提供令人满意的杯状件保持。
在将杯状件安装在髋臼内之后，外科医生通常需要将试验插入件装在杯状件内，此插入件的形状与假体的永久插入件基本相同并用于一次或多次接纳关节的凸部分。这使得外科医生能试验关节的凸部分的多种尺寸，并进行灵活性测试。这旨在使得外科医生能根据患者的形态学选择关节的凸部分的最合适的尺寸。然后，外科医生除去试验插入件以插入永久插入件，选择的关节的凸部分的头部将被容纳在其中。
对于这些操作，在使用上述参考文献中所述的装置时，外科医生因此必须能利用较大量的待组装部件，每个部件都必须是无菌的：髋臼杯假体、试验插入件、永久插入件、多个人造凸部分以及用于在安装杯状件的同时保持该杯状件的复杂器械。特别地，上述文献都没有指出或使得冲击器头部具有试验插入件的作用，以使该试验插入件能够接纳股骨头。
如果患者具有不同尺寸，则外科医生必须具有足够的重要部件储备，这会增加固定资产的总成本。
发明内容
本发明通过提出一种新颖的器械以避免已知髋臼杯假体安装器械的缺陷，该新颖的器械确保并控制用于操纵杯状件并将杯状件安装在髋臼内的冲击器上的机械力，而完全不存在因该器械而使杯状件的凹远端面变形或恶化的危险。
通过根据本发明的装置，应当能将杯状件压紧在髋臼内、以精确且令人满意的方式将该杯状件定向并将该杯状件正确地固定在髋臼内，而不会损害杯状件的凹远端滑动面，并且杯状件的外表面上不存在任何多余物或者破坏围绕杯状件的骨头的周缘区域。
根据本发明的装置应当能无区别地应用于单移动性假体和双移动性假体。
本发明的另一目的是减小外科医生在安装假体时必须组装的无菌部件的数量。因此可减少器械的储存量并有助于外科医生的工作，同时降低与操作相关联的危险。
根据本发明的另一目的，为确保将杯状件高质量地固定在骨头内，应当能在不向杯状件施加可使该杯状件相对于其固定在其中的骨头平移或旋转的机械力的情况下使器械和杯状件分离。
为实现上述以及其它目标，本发明提出一套髋臼杯假体安装装置，其包括由凸近端面、具有滑动面的凹远端面和周向唇缘限定的杯状件，还包括用于将杯状件紧固在冲击器上的接合器，该接合器包括：
-用于将接合器可拆下地固定在冲击器上的固定装置，
-杯状件上的固定装置，当接合器固定在杯状件上时在该接合器和杯状件之间留有自由空间，
-进入孔，接合器和杯状件之间的自由空间通过该进入孔与外部连通，
其中：
-该杯状件在其凹远端面上具有柱状或略微呈锥状的环形保持面，该保持面使该滑动面朝周向唇缘延伸，
-该接合器包括柱状或略微呈锥状的环形接合面，该接合面的形状与杯状件的环形保持面相同，
-结果，接合器可在其环形接合面被沿径向夹紧在杯状件的环形保持面内的情况下被以流体密封的方式强制保持。
由于接合器成形为围绕其周缘以流体密封的方式被强制保持在杯状件内，该接合器仅靠在杯状件的凹远端面的环形保持面上，远离滑动面，从而避免在杯状件的滑动面上产生任何不规则部。
此外，由于在接合器通过其环形接合面以流体密封的方式被强制保持在杯状件内之后在该接合器和杯状件之间留有自由空间，并且由于接合器包括进入孔，因此随后可通过经由该进入孔向接合器和杯状件之间的自由空间注射加压流体—有利地是加压液体—来从杯状件取回该接合器。所述加压流体产生对称的轴向合成力，该轴向合成力可将接合器从杯状件排出并向杯状件的滑动面施加机械应力，该机械应力由于流体压力而规则地分布。这还可避免杯状件的滑动面发生任何局部变形，并且防止向杯状件施加任何牵引、振荡或旋转应力。
接合器在杯状件内的强制固定可足以确保接合器并从而确保杯状件牢固地紧固在冲击器上。
但是，此外优选在杯状件的周向唇缘上设置用以沿轴向靠接接合器的止挡装置，以限制该接合器进入杯状体。从而，冲击器可向接合器施加较大的冲击力，该力一方面通过接合在杯状件内的接合器的环形面而另一方面通过支靠在杯状件的周向唇缘上的止挡装置传递给杯状件。
有利地，可通过使杯状件的环形保持面包括至少一个环形凹槽并且使接合器的环形接合面包括至少一个用于接合在环形凹槽中的对应环形肋改进杯状件到接合器的紧固。凹槽和肋的深度较小以改进紧固，但是不会危及随后的接合器与杯状件的分离。
杯状件可优选包括大致为半球形的滑动面，该滑动面有利地经过镜面抛光、通过短柱形或略微呈锥形的环形保持面延伸。然后，接合器能够靠在不是杯状件的滑动面的环形保持面上，这减小了施加在半球形滑动面上的机械应力。
接合器可通过任何装置紧固在冲击器上。但是，用于将接合器固定在冲击器上的装置优选地包括接合器内的用于旋拧在冲击器的对应螺纹部分上的带螺纹的固定孔。如果固定孔不是该进入孔，则该固定孔必须是盲孔。
根据本发明的接合器用作冲击器和杯状件之间的连接装置。
但是，通过使接合器在远端面上具有其尺寸能接合股骨假体的头部的半球形腔，可有利地使该接合器具有第二功能—即临时试验插入件功能。该半球形腔可与接合器的凸近端面同心，在双移动性假体的情况下尤其如此。很清楚，这减小了将被外科医生组装以安装假体的部件的数量，因为不再需要与接合器分离的专用试验插入件。
有利地将通向杯状件和接合器之间的自由空间的进入孔的形状和尺寸设计成使得注射器的端部能流体密封地接合在其中。这样，可利用简单的注射器—外科医生通常可利用的器械—注入加压流体而不需要另外设备。
优选地，接合器的进入孔可带有螺纹以通过使冲击器的对应带螺纹部分能旋拧在接合器内来同时实现接合器固定孔的作用。
然后，接合器的进入孔可有利地位于半球形腔的底部内，该半球形腔的尺寸形成为允许接合股骨假体的头部。
如已知的假体中那样，试验插入件型接合器可用聚乙烯制成。另一方面，永久插入件可用聚乙烯或陶瓷制成。
还提出一种具有带螺纹部分的冲击器，该带螺纹部分用于将冲击器旋拧在接合器的带螺纹的固定孔内。
优选地，冲击器还可在带螺纹部分的基部具有半球形部分，该半球形部分的形状和尺寸设计成能被容纳在接合器的对应的半球形腔内。这使得机械应力在冲击器和接合器之间分布更均匀，该应力较高并且在杯状件压在髋臼内时出现。
根据本发明，有利地向外科医生提供临时试验插入件型接合器，该接合器的环形接合面事先被以流体密封的方式强制固定在杯状件的环形保持面内，此组件有利地是无菌的并且被包装在密封的保护套内。
在组装接合器和杯状件时—该组装在可生产厂内进行，可有利地使用下列连续的步骤：
a)将接合器冷却以减小其尺寸，
b)将接合器安置在杯状件内，
c)当接合器在杯状件内就位后，使该接合器返回室温以便膨胀，从而接合器的环形接合面以流体密封的方式被强制固定在杯状件的环形保持面内。
还优选地提供这样的步骤，即，当接合器和杯状件已经紧固在一起后，利用伽马射线对接合器和杯状件进行杀菌。
安装杯状件之后，可通过这样的步骤使接合器与杯状件分离，在该步骤中，通过进入孔将加压流体—有利地为加压液体注入接合器和杯状件之间的自由空间。
附图说明
从下面参照附图对具体实施例的说明中可了解本发明的其它目的、特征和优点，在附图中：
-图1是根据本发明一个实施例的组件的透视图，该组件包括其中将强制接合试验性地嵌入且临时插入的接合器的髋臼杯假体；
-图2是插入密封的保护套中的图1的组件的侧视图；
-图3是图1的组件的正视图；
-图4是沿图3的线A-A截取的径剖面的侧视图；
-图5是示出接合在图4的插入件-杯状件组件的临时插入件内的冲击器的剖面侧视图；
-图6是示出接合在根据本发明的插入件-杯状件组件内的临时插入件的通道内的注射器的剖面侧视图。
具体实施方式
在图1到4所示的实施例中，髋臼杯假体安装器械包括杯状件1和与嵌入式临时试验插入件相吻合的接合器2。
杯状件1构成将固定在盆骨的髋臼内的永久杯状件。
另一方面，接合器2至少用作在杯状件1和冲击器之间的中间部件，该冲击器用于当将杯状件1安装在髋臼内时操纵该杯状件，然后该接合器2将被永久插入件替换。
杯状件1是具有较薄的壁的半球体，其具有大致为半球形的凸近端面3和包括半球形滑动面5a的凹远端面5，该凸近端面3在图4内可更好地看到并任选地具有锚定翅片4，该滑动面5a通过柱形或稍微呈锥形的环形保持面5b延伸到周向唇缘6。
杯状件1的半球形面5a优选地为光滑且规则的并优选经镜面抛光，以便构成滑动面，半球形永久插入件可在该滑动面内很好地枢转，该插入件在杯状件1装在髋臼内之后被引入该杯状件1中。
接合器2具有由凸近端面7和具有半球形腔8的远端面11限定的大致弄圆的形状。
接合器2的凸近端面7具有柱形或略微呈锥形的环形接合面7a和从构成杯状件1的半球形滑动面5a的半球形形状后退的中心圆顶7b。结果，在图4所示的配合状态，在临时插入件2和杯状件1之间存在自由空间9。
环形接合面7a具有与环形保持面5b对应的形状，并且该接合面7a直径使得该接合面能被强制保持在杯状件1的环形保持面5b内，以便接合器2和杯状件1能构成可经受高的机械应力而不会彼此相对地移动的子组件，该应力大于当将杯状件安装在髋臼内时必须施加在该杯状件上的力。
在图5和6内，环形接合面7a和环形保持面5b是光滑的。
或者，在图4的实施例中，杯状件1的环形保持面5b包括至少一个环形凹槽5c，而接合器2的环形接合面7a包括至少一个对应的环形肋7c，该肋适于接合在环形凹槽5c内。
接合器2的半球形腔8的尺寸形成为可接纳股骨关节凸部分中的球关节头。因此，接合器2可构成临时试验插入件。
接合器2的底部设有进入孔10，位于接合器2和杯状件1之间的自由空间9通过该进入孔与外部连通。
接合器2的远端面11的边缘为圆形周向肋12，该肋构成在图4所示的压配合位置支靠杯状件1的周向唇缘6的止挡装置。结果，周向肋12阻止接合器2进一步刺入杯状件1。在附图所示的实施例中，进入孔10还构成用于可拆开地固定冲击器的装置。为此，该进入孔包括内螺纹10a。
现在考虑图5，其再次示出杯状件1、临时试验插入件型接合器2、接合器2的半球形腔8和带螺纹的进入孔10。
该附图还示出冲击器13，该冲击器包括柄13a、杆13b和旋拧在带螺纹的进入孔10内的带螺纹端部13c。冲击器13优选地在带螺纹部分13c的基部包括半球形部分13d，该半球形部分的外形和尺寸形成为能容纳在接合器2的对应半球形腔8内。因此，冲击器13用于在杯状件1插入并在髋臼中定位期间操纵该杯状件。
图6示出将接合器2从杯状件1分离的步骤。在此实施例中，设有注射器14，该注射器含有合适的液体例如生理盐水并具有流体密封地接合在接合器2的进入孔10内的尾端件14a。然后，使用注射器14在压力下将液体注入自由空间9，从而使接合器2与杯状件1分离。
或者，为避免使用辅助的注射器，冲击器13可包括管状柄：从而图5示出包括轴向通道13e的冲击器13。在分离步骤期间，可将液体引入轴向通道13e，然后引入一活塞杆13f，该活塞杆强制液体进入自由空间9。
在附图所示的实施例中，接合器2包括半球形腔8以实现临时试验插入件的作用。但在不脱离本发明的范围的情况下，接合器2也可不具有这种半球形腔，而是仅用作用于利用冲击器13将杯状件1定位在髋臼内的接合器。
同样，在所示实施例中，进入孔10同时用作用于将冲击器13固定在接合器2上的装置。或者，可在接合器2的中心部分设置孔以固定冲击器13，而用于注入液体的进入孔10可移位。用于固定冲击器的孔在此情况下必须是盲孔。
下面将说明根据本发明的器械的使用。
在工厂中，可通过包括以下步骤的过程将接合器2组装在杯状件1内：
a)将接合器2冷却到足够低的温度以稍微减小其尺寸，所述尺寸最初使得在相同温度下接合器2的环形接合面7的直径稍大于杯状件1的环形保持面5b的直径；降低接合器2的温度将减小其外径，从而有助于进入本身保持为室温的杯状件1以进行接合；
b)然后将接合器2定位在杯状件1内，从而周向肋12靠接周向唇缘6；
c)在杯状件1中就位后，接合器2可返回室温以膨胀，从而该接合器2压配合在杯状件1内，并通过其环形接合面7a被流体密封地强制保持在杯状件1内。
然后在密封的保护套15(图2)内利用伽马射线对接合器-杯状件组件进行杀菌。从此刻开始，将接合器-杯状件组件以无菌状态包装在密封的保护套15中。
在使用位置即在手术室中，外科医生除去密封的保护套15，并将无菌冲击器13旋拧到进入孔10内。然后，外科医生利用冲击器13和压配合的接合器2操纵杯状件1，向杯状件1提供安置和定向杯状件1所需的所有机械力。
然后，外科医生通过旋松冲击器13来取下该冲击器。
接着，外科医生将临时插入件型球关节头装配在接合器2的半球形腔8内，然后将其用作临时试验插入件。
已选定假体的凸部分后，外科医生可通过利用如图6所示的注射器14引入加压的液体或其它流体或者在如图5所示具有活塞杆13f和轴向通道13e的冲击器13中将临时插入件2从杯状件1取下。
然后，将永久插入件装在杯状件1内，该杯状件本身已在髋臼中就位。
所有上述操作都可在不使杯状件1的半球形滑动面8变形并且不在杯状件1上施加不希望的力的情况下进行。
本发明并不局限于已明确说明的实施例，而是包括在下面的权利要求范围内的变型和概括。

Claims (18)

1.髋臼杯假体安装装置组件，包括由凸近端面(3)、具有滑动面(5a)的凹远端面(5)和周向唇缘(6)界定的杯状件(1)，还包括用于将该杯状件(1)连接在冲击器(13)上的接合器(2)，该接合器(2)包括：
-用于将接合器(2)可拆下地固定在冲击器(13)上的固定装置(10，10a)，
-杯状件(1)上的固定装置，当接合器(2)固定在杯状件(1)上时在该接合器(2)和杯状件(1)之间留有自由空间(9)，
-进入孔(10)，接合器(2)和杯状件(1)之间的自由空间(9)通过该进入孔与外部连通，
其特征在于：
-该杯状件(1)在其凹远端面(5)上具有柱状或略微呈锥状的环形保持面(5b)，该环形保持面使所述滑动面(5a)朝周向唇缘(6)延伸，
-该接合器(2)包括柱状或略微呈锥状的环形接合面(7a)，该环形接合面的形状与杯状件(1)的环形保持面(5b)一致，
-从而，接合器(2)可在其环形接合面(7a)被沿径向夹紧在杯状件(1)的环形保持面(5b)内的情况下被以流体密封的方式强制保持。
2.根据权利要求1的组件，其特征在于，接合器(2)包括止挡装置(12)，该止挡装置用于沿轴向支靠在杯状件(1)的周向唇缘(6)上以限制接合器(2)进入杯状件(1)。
3.根据权利要求1或2的组件，其特征在于，杯状件(1)的滑动面(5a)基本为半球形、通过短的柱状或略微呈锥状的环形保持面(5b)延伸。
4.根据权利要求1到3中任一项的组件，其特征在于，杯状件(1)的环形保持面(5b)包括至少一个环形凹槽(5c)，接合器(2)的环形接合面(7a)包括至少一个用于接合在所述环形凹槽(5c)中的对应环形肋(7c)。
5.根据权利要求1到4中任一项的组件，其特征在于，所述用于将接合器(2)固定在冲击器(13)上的装置包括接合器(2)内的带螺纹的固定孔(10)，以用于使冲击器(13)的对应的带螺纹部分(13c)旋入。
6.根据权利要求1到5中任一项的组件，其特征在于，通向杯状件(1)和接合器(2)之间的自由空间(9)的进入孔(10)的形状和尺寸设计成使得注射器(14)的端部(14a)能以流体密封的方式接合在其中。
7.根据权利要求1到6中任一项的组件，其特征在于，接合器(2)的进入孔(10)带有螺纹(10a)，以便通过使冲击器(13)的对应带螺纹部分(13c)能旋入该接合器(2)内来实现接合器固定孔的作用。
8.根据权利要求7的组件，其特征在于，冲击器(13)包括具有轴向通道(13e)和活塞杆(13f)的管状柄，液体能通过该轴向通道(13e)引入，该活塞杆(13f)强制液体进入自由空间(9)。
9.根据权利要求1到8中任一项的组件，其特征在于，接合器(2)是在其远端面(11)上包括半球形腔(8)的临时试验插入件，该半球形腔(8)的尺寸设计成能够接合股骨假体的头部。
10.根据权利要求9的组件，其特征在于，接合器(2)的进入孔(10)位于半球形腔(8)的底部。
11.根据权利要求9或10的组件，其特征在于，接合器(2)由聚乙烯制成。
12.根据权利要求1到11中任一项的组件，其特征在于，该组件还包括冲击器(13)，该冲击器具有用于旋拧在接合器(2)的带螺纹的固定孔(10)内的带螺纹部分(13c)。
13.根据权利要求12的组件，其特征在于，该冲击器(13)还在带螺纹部分(13c)的基部包括半球形部分(13d)，该半球形部分的形状和尺寸设计成能被容纳在接合器(2)的对应的半球形腔(8)内。
14.根据权利要求1到13中任一项的组件，其特征在于，接合器(2)的环形接合面(7a)被以流体密封的方式强制固定在杯状件(1)的环形保持面(5b)内。
15.根据权利要求14的组件，其特征在于，该接合器-杯状件组件以无菌状态包装在密封的保护套(15)内。
16.用于组装根据权利要求1到15中任一项的组件中的接合器(2)和杯状件(1)的方法，其特征在于，该方法包括以下步骤：
a)将接合器(2)冷却以减小其尺寸，
b)将接合器(2)安置在杯状件(1)内，
c)当接合器(2)在杯状件(1)内就位后，使该接合器(2)返回室温以便膨胀，从而接合器(2)的环形接合面(7a)被以流体密封的方式强制固定在杯状件(1)的环形保持面(5b)内。
17.根据权利要求16的组装方法，其特征在于，该方法包括当接合器(2)和杯状件(1)已经连接在一起后，利用伽马射线对接合器和杯状件进行杀菌的步骤。
18.用于使根据权利要求1到15中任一项的组件中的接合器(2)与杯状件(1)分离的方法，其特征在于，该方法包括通过进入孔(10)将加压流体一有利地为加压液体注入接合器(2)和杯状件(1)之间的自由空间(9)内的步骤。
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