CN102056572A - 组装式的股骨头假肢 - Google Patents

组装式的股骨头假肢 Download PDF

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Publication number
CN102056572A
CN102056572A CN2009801210907A CN200980121090A CN102056572A CN 102056572 A CN102056572 A CN 102056572A CN 2009801210907 A CN2009801210907 A CN 2009801210907A CN 200980121090 A CN200980121090 A CN 200980121090A CN 102056572 A CN102056572 A CN 102056572A
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CN
China
Prior art keywords
femoral head
artificial limb
head artificial
packing ring
assembled femoral
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN2009801210907A
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English (en)
Inventor
A·凯勒
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Waldemar Link GmbH and Co KG
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Waldemar Link GmbH and Co KG
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Publication date
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Publication of CN102056572A publication Critical patent/CN102056572A/zh
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Abstract

本发明涉及一种组装式的股骨头假肢，它包括一个用来插入股骨的髓心孔中的柄部(1)和一个带有定位面(25)的颈部(2)，后者用螺栓(3)固定在柄部(1)的端部。根据本发明，至少配置了一个分离的垫圈(4)，该垫圈放置在柄部(1)的支撑面(15)和颈部(2)的定位面(25)之间并用螺栓(3)固定。这样，通过一个零件的简单交换就可便捷地制备不同尺寸的股骨头假肢，这种假肢有利于手术医生即使在手术中发现困难时也能调整假肢的长度。

Description

组装式的股骨头假肢
技术领域
本发明涉及一种组装式的股骨头假肢，它包括一个用来插入股骨髓心孔中的柄部和一个带有定位面的颈部，后者用螺栓固定在柄部近端上的支撑面上。
背景技术
在由于磨损或生病引起自然股骨头区域产生缺损并在植入人工髋关节的情况下装配股骨头假肢是有疗效的。众所周知，股骨头假肢有各式各样的结构型式，其中的差别特别表现在股骨的固定方式上。确切地说，这种差别涉及插入柄的形状和尤其是其长度。柄及其长度的选择应适应患者个体的解剖学的比例关系。为了使所需的不同假肢件数保持很少，股骨头假肢须按模块方式进行组装，这是熟知的。例如有一种熟知的结构就是把锚定在股骨的一个髓心管中的柄部和支承构成髋关节关节球的头部用膨胀螺栓连接在一起(EP-A-0 843 251)。用这种组装式的股骨头假肢固然可以达到所需的件数的明显减少，但要考虑所需的柄长和/或头部高度方面的个体差别，仍然需要相当多的件数。
发明内容
本发明的目的在于对上述组装式的股骨头假肢进行如下改进，使之用较少的件数即可满足需要。
本发明的解决方案示于具有独立权利要求所述特征的股骨头假肢中，诸多有利的改进则可从各项从属权利要求中得知。
组装式的股骨头假肢包括一个用于插入股骨的髓心孔中的柄部和一个带有定位面的颈部、后者用螺栓固定在颈部近端上的支撑面上，根据本发明，至少配置了一个分离的垫圈，该垫圈布置在柄部的支撑面和颈部的定位面之间并用螺栓固定。
本发明用这种在柄部和颈部之间布置垫圈的方式达到了患者个体解剖学上需要的股骨头假肢的较好适配性，其中由于该垫圈被框入凹槽中，达到了高的连接安全性。使用本发明垫圈可改变股骨头假肢的有效的柄长度而无需许多具有不同长度的柄部。所以手术医生在手术中也能改变股骨头假肢的有效的柄长，而不需要另外的柄部。这样，例如在骨缺损比手术计划预期的范围扩大并由此需要较长的柄长的情况下，手术医生也能灵活地在手术过程中对改变的要求有效地作出反应。此外，沉入式布置的优点是，通过柄部的垫圈相互啮合到颈部的凹槽内，构成了一个导向装置，来使柄部和颈部相互保持在一个规定的位置内。所以本发明兼有件数少和可变性大的优点，也即由于沉入式的布置，而不减弱各部件之间的连接稳定性。
支撑面和定位面宜设计成基本上呈平面，这里所谓基本上呈平面指的是这两个面没有类似定心销那样的结构元件。平面的形状一方面具有容易制作的优点，另一方面的优点则是为力的传递提供了大的不间断的面积。同样地，还容易进行装配，因为这与装有结构元件的情况有所不同，不会在柄部和颈部连接时产生倾斜或卡住。
所用的螺栓最好为膨胀螺栓。所谓膨胀螺栓这里指的是其螺纹和螺栓头之间的一段螺杆直径比螺纹芯部直径小的螺栓。这种形状的膨胀螺栓具有这样的优点，即使在安装植入的部件时或在持续负荷和振荡负荷的影响下，螺栓也不会产生松动的危险，这对使用多个垫圈的情况尤为重要。通过使用这种膨胀螺栓，明显地提高了植入的假肢的固定可靠性和功能可靠性。
框状的凹槽最好设计成套状，该套的内表面包围住柄部的近端，而其底部则构成定位面、这样柄部近端的整个横截面面积都可作为支撑面使用，从而提供了一个大的传递载荷的面积。柄部的近端的外表面最好设计成导向面。这里所谓导向面指的是它与该套共同作用，对倾覆力矩和弯曲力矩提供了一个实际上没有间隙的支撑。
此外，螺栓的螺纹段的长度最好大于该垫圈的厚度。这样，不论在具体使用情况中是否使用某一种垫圈，都可使用同一种螺栓。因此，无需为本发明带有或不带有垫圈的假肢的使用配置单独的螺栓。这特别适用于配置有不同厚度的多种垫圈的情况。如果螺纹的长度至少是最薄那种垫圈的厚度时，则可实现螺栓数目的减少。
最好配置两种不同的垫圈，其厚度保持1∶3的比例。在这种情况下，通过选用两种垫圈就可提供5种不同的长度(完全不用或用一个1倍厚度的垫圈、用两个2倍厚度的垫圈、用一个3倍厚度和1倍厚度的垫圈)。如果不用两种垫圈而用三个其厚度比为5∶2∶1的垫圈，则可达到长度变化可能性的加倍。用这三种垫圈可在最薄的垫圈的1倍和8倍之间调节总厚度。加上根本就不配置垫圈的方案，则对这三种垫圈来说，就可产生总共9种不同的长度方案。当然，作为长度变化不只用一种螺栓为宜，而是按不同的长度配置多种螺栓。这样可进一步减少不同零件的数目。其中螺栓最好这样设计，特别是螺纹长度应选择是够大，以使不同的螺栓数目小于组合的垫圈数目。
支撑面和定位面最好设置相互配合的啮合齿。由于这种啮合齿，柄部和颈部可有效地防止不希望出现的相互扭转。为此，这种啮合齿宜做成径向啮合齿。这种径向啮合齿一方面能可靠地防止两个零件的不希望的相互扭转，另一方面又可实现相互的定中心。
最好配置一个力矩支撑柄，使其以可拆卸的方式与颈部连接，这样就可通过它承受在拧紧螺栓时对颈部产生的反向扭矩，从而可避免反向扭矩的不希望的引入柄部。力矩支撑柄最好为颈部的定位锥体设置一个定位装置。通常为了支承关节球而设置的现成的固定锥体反正设计得足够大而且一般可供使用。力矩支撑柄用上述定位装置就可以简便的方式连接到颈部。如果在该定位装置上布置一个带手动偏心轮的夹紧机构乃是特别适宜的。这样，作手术的医生无需别的工具就可把力矩支撑柄与颈部连接起来，或者在拧紧螺栓后又可从颈部松开。
最好配置一个测定扭矩的拧紧扳手。这里所谓测定扭矩的拧紧扳手指的是这种扳手可调到预定的力矩值。通过指针和标度显示特别适用，即当预定的力矩值达到后，指针便指到该标度。
本发明进一步涉及到一套带有多个不同厚度的垫圈的组装式股骨头假肢。
附图说明
下面参照附图来说明本发明，附图中示出了一个有利的实施例。附图表示：
图1本发明组装式股骨头假肢的零件分解图；
图2a-c图1所示本发明组装式股骨头假肢的不同长度的三个例子；
图3图1所示本发明组装式股骨头假肢所用的螺栓的结构型式；
图4图1组装式股骨头假肢的垫圈；
图5该组装式股骨头假肢用一个垫圈的颈部的放大图；
图6用在图1组装式股骨头假肢上的力矩支撑柄的俯视图；
图7图6所示力矩支撑柄的夹紧装置的放大圈；
图8图3所示螺栓的拧紧扳手。
具体实施方式
按附图所示的实施例，组装式股骨头假肢包括一个柄部1和一个颈部2，它们通过一个放置在颈部2上的并啮合到柄部1的、作为螺栓紧固件的膨胀螺栓3相互连接在一起。此外，这种“组装式股骨头假肢可具有一或多个垫圈4。
柄部1包括一逐渐呈锥形缩小的下锚定区11，该锚定区带有若干沿着柄部1的纵向延伸的锚固筋12。此外柄部1在其上部区域包括一个减小了横截面的连接件13，该连接件基本上具有圆柱形的表面14，其外轮廓与垫圈4的外轮廓一致。在其上端，它具有一个配有径向啮合齿16的支撑面15。
颈部2分为两个功能区：第一功能区为固定区21，它包括人工髂关节的关节球(未示出)用的构成截头锥体的固定轴；而其第二功能区则包括锚固区22，其远端邻接固定区21并沿股骨头假肢的纵轴方向延伸。锚固区22在其远端有一个锚固套24，其口径和形状设计成与垫圈4和圆柱形连接件13的口径和形状一致。该套24用其大致垂直于股骨头假肢纵轴延伸的底部25构成定位面，该定位面设计成与柄部1的支撑面15共同作用。为此，该定位面25具有径向啮合齿，该啮合齿与柄部1的径向啮合齿互补。该套24的深度是这样选择的，即垫圈4和支撑面15在装配好的状态下至少可以沉入其中，因而构成一个框腔。由于径向啮合齿以及由于该框腔，便可借助套24实现两个部分的可靠而精确定位的装配。
柄部1在其近端在支撑面15的中心有一个螺栓连接孔16，该孔做成盲孔并配有内螺纹，其尺寸与膨胀螺栓31的螺纹一致。所以通过螺栓31的简单拧紧就可达到本发组装式股骨头假肢的柄部1和颈部2之间的牢固和抗扭的连接。
此外，不只配有一个垫圈4，而是配有一组不同的垫圈4、4’、4”，其区别主要是厚度不同；其余外部尺寸以及底面和顶面的径向啮合齿最好都是相同的。螺栓连接件设计成带有减小螺杆直径31的市售膨胀螺栓3，膨胀螺栓3的下端即远端设置有细螺纹32，其长度是这样选择的，即只用一个螺栓就可实现组装式股骨头假肢的两个不同的尺寸(长度)。为此，膨胀螺栓3的螺纹32的长度至少要像两个不同垫圈4、4’的厚度差那样长。这样就可把同一个膨胀螺栓3用于垫圈4、4’、4”的至少两种不同的尺寸。从而达到了这样的目的：只用图3所示的少量不同长度的膨胀螺栓3、3’即可组合大量的垫圈。这里所谓螺纹32的长度指的是实际的有效长度，即扣除了螺纹始端或终端的可能没有完全承载的螺纹线。膨胀螺栓3设计成用一定的力从而用一定的扭矩即可实现预拧紧，其优点是可在螺栓连接中集成一定的弹性，这样即使在颈部2、垫圈4、4’、4”和柄部1之间产生小运动(所谓微运动)的情况下，也不会出现螺栓连接的松动。为了用正确的扭矩拧紧膨胀螺栓3，最好用图8所示的拧紧扳手，对这种扳手稍后还要进行详细说明。
图4所示的不同垫圈4、4’、4”具有5∶2∶1的厚度比。例如最小厚度的垫圈4具有5毫米的厚度，中等厚度的垫圈4’具有10毫米的厚度，而最大厚度的垫圈4”则具有25毫米的厚度。用这种厚度比只需三种不同的垫圈4、4’、4”即可达到最小垫圈4的厚度的一倍至八倍的全部厚度尺寸，其中最多用三种垫圈，并在一直到七倍厚度的全部情况中只需两种垫圈。这样，一方面从灵活性来说几乎达到了最佳的折衷，另一方面又达到了垫圈4、4’、4”数的减少。这样组成的不同长度的股骨头假肢2、2’、2”的例子如图2a、b、c所示。
在手术过程中，手术医生只需根据具有情况就可确定组装式股骨头假肢的希望长度，并根据这个长度选出垫圈4、4’、4”的数量和种类。垫圈被插入颈部2的套24中，如图5所示。安装时通过垫4推动膨胀螺栓3的螺纹32，直至它从垫圈4伸出为止，然后继续拧入膨胀螺栓，直至没有螺纹32为止，于是垫圈4包围柄31。这时可接上连接件13并把膨胀螺栓3的螺纹32拧入定位孔16中。通过用拧紧工具6拧紧，柄部1和颈部2便相互牢固连接。如欲组装式股骨头假肢具有长一点的长度，则只需用较大厚度的垫圈4’代替垫圈4即可。因为螺纹32的长度宜大于垫圈4和垫圈4’的厚度之间的厚度差，所以螺纹32即使在戴上较厚的垫圈4’时仍然在下方从垫圈4’伸出，这样它就可在不作任何改变的情况下直接引入柄部1的定位孔16中并拧紧。只有在需要使用多个或相差大的垫圈4”的较大长度变化时，才可能需要使用另一种较长的膨胀螺栓3’(见图3)。
为了便于植入组装的股骨头假肢，专门设置了一个扭矩支撑柄5，该柄是为了更好地支撑在最终拧紧螺栓3时产生的反向扭矩设计的，被推到用于定位关节头(未示出)设置的锥体22上。这样就能使在拧紧螺栓时产生的力矩不作用到柄部1。扭矩支撑柄5包括一个可用一只手握住的手柄51，在其远端52有一个定位头52，在手柄51和定位头52之间的过渡区设置一个环53作为挡块。在定位头52内为颈部2的锥体22设置了一个定位孔54。此外，在头部52还设置了一个夹紧装置55，该装置包括一个夹紧片56，后者布置在环53的远端的正面而可旋转，并具有一个伸入定位孔54区域内的偏心轮57。在定位孔54中布置了一个塑料杯58，该杯罩住定位孔54的侧壁和底部。塑料杯58是柔性的，其外表面紧贴夹紧装置55的偏心轮区57。偏心轮区57是这样设计的，即它在夹紧片56转到环53上时可挤压塑料杯58。这样，插入定位孔54内的锥体22就能可靠固定在扭矩支撑柄5上。偏心轮57通过叶片56的简单的返回运动回到塑料杯58不再挤压锥体22的位置、于是该锥体被松开、则可轻易取下扭矩支撑柄5。
为了在植入时螺栓3即使在困难的条件下也能可靠地用要求的扭矩拧紧，特为此配置了一个拧紧扳手6，它包括一个手柄61，后者通过一根延长的扭力棒62与插套63连接。该插套设计成可套装在螺栓头33上，以便转动膨胀螺栓3。为此，插套63的下部有一个六角孔，其口径与螺栓头33的外轮廓匹配。插套63的上部抗扭地布置了一个用钢制成的刚性测杆64，该测杆与扭力棒62平行延伸且在其手柄侧端有一个指针65。该指针与固定布置在手柄61上的扭矩标度67共同作用。后者设有零力矩以及希望的拧紧力矩的刻度66。拧紧扳手6按众所周知的方式使用，即在拧紧膨胀螺栓3时，可在扭矩标度尺67上观察到在扭力棒62和刚性测杆64之间通过相对扭转所施加的扭矩。所以手术医生只需观察标度尺67上的相应刻度66，即使在困难的植入情况或操作情况时也能保证拧紧扭矩的正确值。

Claims (18)

1.组装式的股骨头假肢包括一个用来插入股骨髓心孔中的柄部(1)和一个带有定位面(25)的颈部(2)，后者用螺栓(3)固定在柄部(1)的端部，
其特征为，
至少配置了一个分离的垫圈(4)，该垫圈放置在柄部(1)的支撑面(15)和颈部(2)的定位面(25)之间并用该螺栓固定，而定位面(25)则沉入一个框住垫圈(4)的凹槽中。
2.按权利要求1的组装式股骨头假肢，
其特征为，
支撑面(15)和定位面(25)基本上都是平面。
3.按权利要求1或2的组装式股骨头假肢，
其特征为，
该螺栓是膨胀螺栓(3)。
4.按前述权利要求任一项的组装式股骨头假肢，
其特征为，
在套(24)的底部构成定位面(25)，其内表面包围住柄部(1)的近端。
5.按权利要求4的组装式股骨头假肢，
其特征为，
柄部(1)近端的外表面(14)构成导向面。
6.按前述权利要求任一项的组装式股骨头假肢，
其特征为，
该螺栓具有螺纹段(34)，其长度大于垫圈(4)的厚度。
7.按前述权利要求任一项的组装式股骨头假肢，
其特征为，
配置了具有不同厚度的多种垫圈(41、42、43)。
8.按权利要求7的组装式股骨头假肢，
其特征为，
配置了两种垫圈，其厚度比为1∶3。
9.按权利要求7的组装式股骨头假肢，
其特征为，
配置了三种垫圈(4、4’、4”)，其厚度比为5∶2∶1。
10.按权利要求7至9任一项的组装式股骨头假肢，
其特征为，
配置了具有不同长度的多种螺栓。
11.按权利要求10的组装式股骨头假肢，
其特征为，
不同螺栓的数目小于垫圈(4、4’、4”)的组合数目。
12.按前述权利要求任一项的组装式股骨头假肢，
其特征为，
在支撑面(15)和定位面(25)上设置有相互啮合的齿部(16)。
13.按权利要求12的组装式股骨头假肢，
其特征为，
该齿部是径向啮合齿(16)。
14.按权利要求1至13任一项的组装式股骨头假肢组成的组装式股骨头假肢组，
其特征为，
配置了具有不同厚度的多种垫圈(4、4’、4”)。
15.按权利要求14的组装式股骨头假肢组，
其特征为，
配置了一个扭矩支撑柄(5)，该支撑柄以可拆卸的方式与颈部(2)抗扭连接。
16.按权利要求15的组装式股骨头假肢组，
其特征为，
扭矩支撑柄(5)为颈部(2)的定位锥体(22)配置了一个定位装置。
17.按权利要求16的组装式股骨头假肢组，
其特征为，
在该定位装置上设置了一个带有一只手操作偏心轮(57)的夹紧装置(55)。
18.按权利要求14至17任一项的组装式股骨头假肢组，
其特征为，
为螺栓(3)配置了一个测定扭矩的拧紧扳手(6)。
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FR2735972B3 (fr) * 1995-06-30 1999-06-11 Mecanurgie Sa Soc Prothese femorale de reconstruction
US6330845B1 (en) * 2000-05-17 2001-12-18 Bristol-Myers Squibb Wrench for an implant
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CN104717940A (zh) * 2012-07-26 2015-06-17 沃尔德马连接两合公司 用于长杆式假体的插接模块
CN103705316A (zh) * 2012-09-28 2014-04-09 德普伊新特斯产品有限责任公司 包括有变化的前/后锥角的股骨杆部件的整形髋关节假体
CN103705316B (zh) * 2012-09-28 2017-06-09 德普伊新特斯产品有限责任公司 包括有变化的前/后锥角的股骨杆部件的整形髋关节假体
CN104902852A (zh) * 2013-01-02 2015-09-09 沃尔德马连接两合公司 具有优化轴的髋部假体
CN103505307A (zh) * 2013-05-01 2014-01-15 刘礼初 一种生物型人工髋关节股骨柄
CN109152582A (zh) * 2016-05-25 2019-01-04 沃尔德马连接两合公司 用于在骨组织中产生缺口的工具
CN109152582B (zh) * 2016-05-25 2021-06-29 沃尔德马连接两合公司 用于在骨组织中产生缺口的工具
CN107693165A (zh) * 2017-10-13 2018-02-16 北京爱康宜诚医疗器材有限公司 股骨假体
CN111447891A (zh) * 2017-12-15 2020-07-24 沃尔德马连接两合公司 带有旋转部件的模块化的内置假体-杆轴系统
CN113367851A (zh) * 2021-05-22 2021-09-10 北京力达康科技有限公司 一种长度可调的髋关节假体

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EP2276422B1 (de) 2018-02-21
TR201807036T4 (tr) 2018-06-21
DE202008004730U1 (de) 2008-07-03
PL2276422T3 (pl) 2018-07-31
ES2662067T3 (es) 2018-04-05
AR073532A1 (es) 2010-11-17

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