CN101039636A - 用于关节替代物的金属轴承 - Google Patents

用于关节替代物的金属轴承 Download PDF

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Publication number
CN101039636A
CN101039636A CNA2005800351539A CN200580035153A CN101039636A CN 101039636 A CN101039636 A CN 101039636A CN A2005800351539 A CNA2005800351539 A CN A2005800351539A CN 200580035153 A CN200580035153 A CN 200580035153A CN 101039636 A CN101039636 A CN 101039636A
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CN
China
Prior art keywords
bearing surface
metal bearing
hardness
hard metal
prosthese
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Granted
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CNA2005800351539A
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CN100551340C (zh
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迈克尔·E·卡罗尔
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Microport Orthopedics Holdings Inc
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Wright Medical Technology Inc
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Landscapes

  • Health & Medical Sciences (AREA)
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  • Transplantation (AREA)
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  • Dermatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)
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  • Non-Disconnectible Joints And Screw-Threaded Joints (AREA)

Abstract

本发明涉及用于关节替代物的金属轴承。本发明提供了一种矫形关节假体，该矫形关节假体包括具有软金属轴承表面的第一组件和具有硬金属轴承表面的第二组件。所述软金属轴承表面具有至少大约20Rc的硬度，而所述硬金属轴承表面具有比所述软金属轴承表面高至少大约15Rc的硬度。所述软金属轴承表面和所述硬金属轴承表面构成为彼此关节连接。所述硬金属轴承表面相对于所述软金属轴承表面的硬度比优选为至少大约1.5，并且优选为小于大约3。所述硬金属轴承表面优选地比所述软金属轴承表面硬出不超过大约40Rc。所述硬金属轴承表面优选地具有大约40Rc与大约60Rc之间的硬度。

Description

用于关节替代物的金属轴承
技术领域
本发明涉及矫形假体，更具体地说，涉及为了减少假体的磨损碎屑并增加其使用寿命而具有不等硬度的金属轴承的假体。
背景技术
矫形关节假体被用于替代诸如在髋部、膝部、踝部或肩部中的患病关节。矫形关节假体包括轴承表面，该轴承表面允许进行与天然关节的关节连接(articulating)表面相似的关节连接。
关于矫形关节假体的一个问题是轴承组件的磨损。在关节连接期间，轴承表面在负载下彼此相对滑动，这导致轴承表面磨损，包括轴承表面的细微颗粒损失。随着时间的推移，这种颗粒在病人体内累积，从理论上讲，这些颗粒可能对某些病人造成不利的生理反应。另外，颗粒的逐渐损失导致轴承表面的侵蚀，这最终可以导致假体损坏。为了使关节假体中的磨损碎屑最小化，已经进行了多种努力。近年来，已经将努力集中于对两个关节连接表面都是金属的金属对金属(“MOM”)关节假体和关节连接表面之一是陶瓷而相对表面是金属的陶瓷对金属(“COM”)假体，以及两个关节连接表面都是陶瓷的陶瓷对陶瓷(“COC”)假体的使用上。
由于硬陶瓷材料提供的耐磨性增加，所以预期COC和COM组合的磨损较低。材料刚性中的差异，尤其是COM组合中的差异，已经被示出易于轴承润滑，由此降低磨损。另外，COM轴承组合具有相对较高的从大约3X到大约5X，并且典型地大约为4X的硬度比(hard differential)范围，这被认为有助于降低磨损率。
尽管COM和COC假体具有低磨损性质，但陶瓷头存在破裂的风险，该风险可能致使某些外科医生远离COM假体，尽管存在低磨损的好处。另外，陶瓷材料的脆性和较低的韧性使其难于制造在表面重整过程中所用类型的大直径的股骨头。与传统的金属对聚合物(“MOP”)假体相比，MOM假体产生较少的磨损颗粒。MOM关节假体通常由遵循ASTM F75和/或F1537规格的钴类合金制成。在传统的MOM关节假体中，相对的轴承表面由相同的钴铬合金制成，由此具有大致相同的硬度(通常来说，从大约25Rc到45Rc的范围)。至今很少将注意力放在MOM轴承表面的硬度上。人们认为除硬度以外的其它因素对MOM髋部假体的磨损率的影响更大。最重要的磨损因素是表面抛光度、清洁度、以及球形度。因此，近来为了改进MOM关节假体的性能，已经将努力集中于改进表面抛光度、清洁度、以及球形度上，而非钴铬轴承表面的硬度上。
尽管与MOP假体相比，MOM假体具有较低的磨损量，但是金属磨损颗粒非常小并且数量高，而且金属磨损颗粒的生理学影响未被完全了解。由此，人们关注于进一步减少来自MOM假体的磨损颗粒量。
在陶瓷对金属(“COM”)关节假体中，陶瓷轴承表面显著硬于金属轴承表面，因此必然会提供混合轴承效果。WO 0117464 A1(Fisher等人)讨论了通过使用COM来改进矫形假体中的磨损。WO 0117464 A1公开了这样选择所述两个表面的材料，即，所述材料的硬度比其它关节系统中的材料硬度大，以减轻两个表面在关节连接期间磨损的趋势，并且所述材料的硬度不等，从而可以确保所述两个表面中的一个在关节连接期间能够大致保持平滑。这又可以导致相对表面的磨损较低。WO 0117464 A1注意到，使用比金属材料显著硬的陶瓷材料具有使陶瓷材料在关节连接期间磨损的趋势最小化的优点。WO 0117464包括的磨损测试数据显示出来自COM假体的磨损碎屑显著少于来自MOM假体的磨损碎屑。根据WO 0117464，MOM假体显示出，对于大约第一个百万周期来说，磨合(bedding in)磨损率为3.12±0.45mm3/106周期，随后其稳定至1.56±0.78mm3/106周期的稳定状态磨损率。与此相比，COM假体显示出，基本上没有磨合阶段，而且在三百万周期测试期间稳定状态磨损率大约为0.01mm3/106周期。来自COM组件的磨损碎屑基本上全部是金属。
在A Novel Low Wearing Differential Hardness，Ceramic-On-Metal HipJoint Prosthesis，34 J’l of Biomechanics，1291-1298(2001)(Firkins等人)中提供了对COM和MOM髋部假体进行比较的进一步数据。在上述文章第1296页，Firkins的文章报告了MOM假体的磨损率，MOM假体的磨损率显示出比COM假体的磨损率高出100倍的磨损度。在上述文章第1293页，Firkins测试了由医用氧化铝(ISO 6474)制造的股骨头和由医用低碳(小于0.07％)精制钴铬合金(ASTM F1537)制造的股骨头。在上述文章第1293页，Firkins将陶瓷和钴铬头与由医用高碳(大于0.2％)精制钴铬合金(ASTM F1537)制造的髋臼杯耦合。在上述文章第1294页，Firkins报告了在第一个百万周期期间MOM假体的磨合率为3.09±0.46mm3/106周期，而稳定状态磨损率为1.23±0.5mm3/106周期。在上述文章第1294页，在测试期间，MOM假体的总磨损率为1.62mm3/106周期。在上述文章第1294页，Firkins注意到，MOM假体的大约70％的磨损出现在低碳钴铬合金头上。与MOM假体磨损相比，在上述文章第1294页，Firkins报告了在五百万周期测试期间COM假体的磨损率为0.1mm3/106周期。由此，在上述文章第1294-1296页，Firkins的结果暗示MOM假体以比COM假体大100倍的速率磨损。
据欧洲专利申请0,841,041 A2(Farrar)报告，如果金属对金属假体的两个关节连接表面由碳含量不匹配的金属形成，则磨损得以改进。根据EP 0,841,041 A2，对碳含量不匹配的MOM髋部假体的测试表明，对于将低碳含量合金用于股骨头而将高碳含量合金用于髋臼杯的假体来说，观察到了最低的平均磨损(重量损失)，反之亦然(第4栏，第46-53行)。据EP 0,841,041 A2报告，对于股骨头和髋臼杯都由低碳含量合金形成或者都由高碳含量合金形成的假体来说，观察到了最高的平均磨损(第4栏，第46-53行)。尽管EP 0,841,041 A2报告了对MOM假体的测试高达两百万周期，但是该专利未能报告实际磨损测试数据，由此，不能定量地评估在该专利中所声称的磨损。
EP 0,841,041 A2没有注意到不匹配碳之间的硬度差别。这大概是因为具有不同碳含量的低碳含量的CoCrMo合金基本上具有相同的硬度值。例如，低碳含量为0.07重量％的CoCr可以具有41Rc的硬度，而高碳含量为0.25重量％的CoCr可以具有42Rc的硬度。
在金属轴承的普通领域中，已经长期将由硬金属轴承与软金属轴承组合构成的混合轴承用于降低轴承组件的磨损上。然而，混合轴承的硬度差是通过由两种不同类型的金属而非由同一类型的金属形成轴承表面来提供的。
尽管现有技术的COM假体默认具有因将不同材料用于两个轴承表面而造成的不等硬度轴承表面，但是，没有尝试探索将不等硬度概念应用至MOM假体的磨损的范围。由此，对于关节假体来说，需要具有超过现有技术的下列特征和优点。
发明内容
本发明的一个目的是提供一种通过利用不等硬度来降低磨损的MOM矫形关节假体。
本发明的另一目的是提供一种通过使用当前用于关节假体的钴铬合金来降低假体接受者中的磨损碎屑量的MOM矫形关节假体。
本发明的这些和其它目的通过提供一种矫形关节假体来实现，该矫形关节假体包括具有软金属轴承表面的第一组件和具有硬金属轴承表面的第二组件。所述软金属轴承表面具有至少大约20Rc的硬度，而所述硬金属轴承表面具有比所述软金属轴承表面高出至少大约15Rc的硬度。所述软金属轴承表面和所述硬金属轴承表面构成为彼此关节连接。所述硬金属轴承表面相对于所述软金属轴承表面的硬度比优选为至少大约1.5，并且优选为小于大约3。所述硬金属轴承表面优选地比所述软金属轴承表面硬出不超过大约40Rc。所述硬金属轴承表面优选地具有大约40Rc与60Rc之间的硬度。
当结合附图考虑时，根据下列对本发明的详细说明，本发明的前述和其它目的、特征、方面以及优点将变得更加清楚。
附图说明
图1是本发明的结合金属对金属不等硬度概念的矫形假体的代表图；
图2是显示根据本发明的不等硬度MOM髋部假体的磨损与传统的MOM和COM髋部假体的磨损的比较的图表；
图3是显示根据本发明的不等硬度MOM髋部假体的磨损率与硬度相同的传统MOM假体的磨损率的比较的图表；
图4是本发明的利用不等硬度概念的模块化(modular)髋部假体结构的侧视图；
图5示出了假体茎部的前视图；
图6是例示假体的茎部与耦合部件之间的耦合的剖视图；
图7示出了假体耦合部件的可能实施例；
图8-12示出了适于应用在假体茎部上并且具有不同延伸纵向轴线的模块化颈部的其它可能实施例；
图13示出了在耦合端部处具有假体耦合部件的假体茎部的另一实施例；
图14和15分别是待与图13所示的假体茎部一起使用的耦合部件的端视图和剖视图。
具体实施方式
在下列对优选实施例的详细说明中，对构成本说明一部分的附图进行了引用，并且在附图中通过例示的方式示出了可以实践本发明的具体实施例。要理解的是，在不脱离本发明的范围的情况下，可以利用其它实施例并且可以进行结构上的改变。
本发明是这样一种矫形关节假体，在该矫形关节假体中，轴承表面中的一个轴承表面的材料是金属材料，而另一个轴承表面的材料是具有与所述一个轴承表面的硬度不同的硬度的金属材料。为了在本发明的讨论中一致和清楚起见，将具有较软金属的轴承表面称为“软金属轴承表面”，而将包含较硬金属的轴承表面称为“硬金属轴承表面”。当然，“软”和“硬”金属轴承表面都是相对术语，并且在此将它们用于说明轴承表面之间的硬度关系，而非绝对的物理特性。
图1提供了本发明的结合不等硬度金属轴承概念的髋部假体的代表图。该假体包括具有第一轴承表面32的第一组件30和具有第二轴承表面52的第二组件50。轴承表面32、52的尺寸和构成使它们按天然关节的方式彼此相对地关节连接。例如，在图1中，第一轴承表面32为凸状，而第二轴承表面52为凹状，以使第一轴承表面32和第二轴承表面52按髋部假体或肩部假体的方式彼此相对地关节连接。在一优选实施例中，凹状轴承表面为软金属轴承表面，而凸状轴承表面为硬金属轴承表面。然而，凹状轴承表面可以是硬金属轴承表面，而凸状轴承表面可以是软金属轴承表面。
软金属轴承表面优选地具有大约25Rc至大约35Rc之间的硬度。硬金属轴承表面优选地具有大约40Rc至大约60Rc之间的硬度。
钴铬合金是本发明中使用的优选金属。钴铬合金具有良好的磨损特性，并且可以被精确地构造成提供希望的球形度、清洁度以及表面抛光度。可以将本发明的不等硬度概念应用至已经通过用于医学装置的FDA批准的所有医用CoCrMo合金。软金属轴承表面的碳含量优选为0.2重量％到0.25重量％。硬金属轴承表面的碳含量优选为0.2重量％到0.3重量％，但是，可以使用低碳合金(小于0.10重量％)。可以将本发明的不等硬度概念应用至具有很少碳含量或没有碳含量的CoCrMo合金。
轴承表面的优选直径将与现有假体的直径匹配。在髋部假体的情况下，优选直径一般将落入大约20mm至60mm之间，优选范围根据髋部假体的类型而进一步改变。
本发明的假体的第一组件和第二组件可以完全由提供轴承表面的金属制成。另选的是，在两个组件中的一个或两个中，轴承表面的材料可以仅提供组件的一部分。例如，髋部假体的股骨组件的球形头可以由钴铬合金形成，该球形头具有锥形中空部，用于接收股骨组件的主体部分的锥形销。可以将髋臼组件制造成分离的外壳和插入物，该插入物提供轴承表面。
可以将本发明的不等硬度概念应用至模块化髋部假体，如美国专利4,957,510(Cremescoli)及其欧洲副本EP 0310566B1中描述的类型，通过引用将它们并入于此。因而，假体可设置有构成为与分离的颈部部件(如固定颈部或模块化颈部)的一端部接合的球形头9。图4-15示出了模块化颈部实施例的示例，该示例还在美国专利4,957,510中示出。参照图4-15，髋部假体结构基本上包括由具有给定长度的扁杆(flat bar)构成的茎部1。表面可以设置有多个纵向狭缝2。具体的说，假体茎部1按照适当弯曲的纵向轴线延伸并且具有大致卵形的底端部3。茎部在其顶部设置有在其凹状周长线的侧部处扩大的部分4，在部分4上形成了卵形截面的具有适当倾斜轴线并且适当锥化(tapered)的座部或凹部5。图4到6清楚显示，扩大的部分4可以具有开槽的倾斜面，在该倾斜面中形成有多个(所示实施例中为三个)隔开的槽，它们被特别设计成用于接收向内生长的股骨，以便在股骨(未示出)中与上述狭缝2共同提供对茎部1的非常牢固的卡合(gripping)。在座部中可以牢固地容纳有小杆或耦合部件7的、也具有卵形截面的一个端部6，该耦合部件7的另一端部8具有锥形或莫尔斯锥度的平截头体，以牢固地限制球形头9(对应于图1中的轴承部30)，球形头9又适用于与病人的骨盆的髋臼耦合。小杆或模块化颈部7可以根据具体使用需求而具有任何希望的可变长度。小杆7可以具有不同的相对于小杆7的接合在茎部的座部5中的端部倾斜的轴线，并且该端部的轴线与所述座部的轴线一致。基本上可以根据与通过限定所述座部的轴线的线设定的平面有关的平面中的任一平面来获得这种倾斜。
如图15所示，茎部的一实施例使用这样的耦合部件，该耦合部件包括偏离其轴向延伸部的插入端部。由此，假体形成为包括实际上构成茎部的顶部的中间弯曲部(由10表示)的延伸部的耦合部件。即使在最小厚度的假体中，这种构造也会提供插入耦合部件的可能性，同时保证茎部耦合部件组件的完美且可再现的定位，而没有两个部分可能脱离的任何风险。
图13到15示出了另一可能实施例，在该实施例中，在茎部1的扩大的端部处设置有耳部20，该耳部20大致呈锥形并具有椭圆形截面。可从耳部20突出一柱形部分21，该柱形部分设置在所述耳部20的轴向延伸部上。更具体地说，可以将耳部20接合并且牢固锁定在配对形状的中空部22中，该中空部22形成在假体的耦合部件的轴向端部(由23所示)处。在需要时中空部22可设置有用于容纳上述柱形部分21的凹部24。
基于U.S.4,957,510的对模块化颈部的前述说明仅仅是可以使用本发明的概念的模块化颈状茎部的一个实施例的示例。可以按本领域技术人员已知的各种构造(如笔直、锥形、矩形，或开缝)来构成茎部1。茎部1的外表面可以是平滑的或者例如具有纵向槽、水平槽、花键、沟槽(flute)或进行表面修整(例如喷砂；等离子喷涂；HA)，或它们的组合。可以设置颈部部件7的各种尺寸和偏移(例如，笔直，前坡度(antegrade)/后坡度(retrotgrad)；内翻/外翻)。茎部1的座部5可以采取多种形式，如卵形、球形、具有圆角的矩形，或者更优选地，采取图7和8所示类型的跑道构造，而模块化颈部7的端部6具有匹配构造。
本发明的一个目的是，通过提供不等硬度轴承表面来降低制造成本，在该不等硬度轴承表面中，相对的关节连接表面中的每一个表面都由当前批准用于矫形植入应用的钴铬合金制造，由此减少制造步骤。然而，应当可以采用另选方式来提供不等硬度轴承系统的硬化组件。可以利用诸如汽相淀积金属氧化物或离子轰击等技术将不等硬度轴承系统的硬化组件设置为表面层，以在表面处生成混合的金属陶瓷基体。另选的是，可以通过热处理来形成所述层，以使与下层金属相比，在轴承表面上赋予更大的硬度。轴承层可以是不连续的，或者可以逐渐过渡至基底金属。
测试/实验
包括下面描述的意外结果的本发明源自Wright Medical发起的以利用当前批准用于矫形植入应用的材料来寻找可能存在的最低磨损的轴承耦合为目的的磨损测试。在测试不等硬度的MOM轴承之前，WrightMedical测试了COM轴承组合以确定磨损率。正如所料，Wright观察到与公布的MOM磨损率相比，COM髋部假体的磨损率降低。要注意的是，COM髋部假体在陶瓷与金属轴承表面之间通常具有大约4X的硬度比，本发明人假定不等硬度轴承提供改进的磨损性能的能力可以存在下限。没有限定与磨损改进有关的对不等硬度的限制。许多硬度磨损模型在描述等式中仅包括一个硬度值，由此不能考虑利用不同硬度的轴承的效果。
为了研究硬度比的下限，Wright Medical决定测试在头部与外壳之间具有相对较低的硬度差的CoCr MOM髋部假体。在测试开始时，认为具有相对较低的硬度差的CoCr MOM假体可能显示出比现有MOM轴承组合略好的磨损特性。事实上，如下所述，测试得出了意外的结果，即，由具有硬度差的CoCr合金制造的髋部假体产生的磨损结果可与利用COM假体获得的磨损结果相当。
为了在不等硬度的下限中测试磨损，在下列股骨头和髋臼杯材料的组合上进行了磨损测试：
1、经铸造且热处理的CoCr头和杯(头和杯两者均遵循ASTM F75；头和杯两者的Rc＝25-30；硬度比＝1.0X；n＝7)
2、经铸造的CoCr头/经铸造的CoCr杯(头和杯两者均遵循ASTMF75；头和杯两者的Rc＝25-30；硬度比＝1.0X；n＝3)
3、精制CoCr头/经铸造-热处理的CoCr杯(头遵循ASTM 1537/杯遵循ASTM F75；头的Rc＝42/杯的Rc＝25；硬度比＝1.68X；n＝3)
4、经热处理的精制CoCr头/经铸造-热处理的CoCr杯(头遵循ASTMF1537HT/杯遵循ASTM F75；头的Rc＝50-52/杯的Rc＝25；硬度比＝2.08X；n＝2)
利用SHORE WESTERN OBM磨损测试机根据用于髋部磨损测试的典型WMT磨损测试协议进行磨损测试(90％的牛血清润滑剂；三重峰值Paul分布(2000N最大@1Hz)；处于倒转位置的试样(头在上/外壳在下))。按特定间隔对试样称重，以确定质量损失。所有试样直径都为54mm。在上述第1组中描述的材料组合当前用于Wright Medical的CONSERVE PLUS MOM髋部假体。与金属对聚合物假体和有竞争力的MOM假体相比，第1组的组合产生了低磨损。然而，如上所述，一些外科医生因从磨损碎屑释放的金属离子带来的潜在副作用而仍然存在对利用MOM假体的忧虑，由此，关注于进一步降低磨损。
在第3组和第4组中，将Wright的典型CONSERVE PLUS髋臼杯(与第1组使用的杯类型相同)抵靠由精制CoCr制成的股骨头进行测试。第3组的股骨头由BIODUR CCM+MICROMELTTM CoCrMo杆(可从Carpenter Technology of Reading，Pennsylvania获得)按原样条件制造，其具有42Rc的硬度。第4组的股骨头由BIODUR CCM+MICROMELTTMCoCrMo杆按热处理条件(在空气中1350华氏温度下达24小时)制造，其获得大约50Rc到52Rc的硬度。与Wright Medical的典型髋臼杯(Rc＝25)相比，精制原样杆和精制热处理杆提供不等硬度。硬度比在大约1.5到2X的范围内。如上所述，陶瓷对金属轴承组合的硬度比典型地在4X左右，并且可以从大约3X到5X或甚至更高的范围变化。
图2和3的图表中示出了测试结果。图2和3的测试结果显示了不等硬度MOM髋部假体轴承的几种意外的特性：(1)与相同类型和相同尺寸的传统MOM假体相比显著更低的磨损；(2)与相同尺寸和相同类型的传统MOM假体相比，磨损率与COM假体的磨损率匹配；(3)总磨损匹配或超过COM假体的总磨损；以及(4)消除了磨合阶段。
如图2所示，与Wright的传统CONSERVE PLUS MOM股骨假体相比，不等硬度金属轴承展示了低得多的磨损。虽然与传统CONSERVEPLUS MOM假体相比，预期不等硬度的MOM轴承的磨损稍微降低，但减少量是惊人的。具有1.68X的硬度比的第3组的MOM假体在整个测试期间仅示出了大约0.107mm3的磨损。具有2.08硬度比的第2组的MOM假体在整个测试期间仅示出了大约0.298mm3的磨损。与此相比，具有1.0X的传统硬度比的CONSERVE PLUS MOM假体在测试期间显示了大约1.478mm3的总磨损。由此，第3组CoCr MOM轴承显示了比相同尺寸(54mm)的CONSERVE PLUS MOM轴承低大约14X的磨损。第4组CoCr MOM轴承显示了比相同尺寸(54mm)的CONSERVEPLUS MOM轴承低大约5.0X的磨损。与公布的MOM髋部假体的数据相比，测试结果也是惊人的。例如，Firkins(上述讨论的)利用不同测试方法已经示出在四百万周期之后的大约8mm3的MOM磨损率。
出乎意料的是，当不等硬度的CoCr MOM轴承和COM轴承与相同尺寸和相同类型的传统MOM轴承相比时，不等硬度的CoCr MOM轴承和COM轴承的磨损上展示了相似的减少。图3示出了与相同尺寸(32mm)的传统MOM系统相比，Wright Medical测试的COM轴承在磨损上展示了大约14.5X的减少。如上所述，具有1.68X的硬度比的第3组的CoCr MOM轴承显示了比相同尺寸(54mm)的典型CONSERVEPLUS MOM轴承低大约14.0X的磨损。
从总磨损的角度来讲，第3组的不等硬度的MOM轴承的磨损平均低于COM轴承的磨损(不等硬度MOM的0.107mm3对比COM的0.172mm3)。尽管第4组的不等硬度MOM轴承没有与COM轴承的磨损结果匹配，但是，第4组的轴承的总磨损与COM轴承处于相同的数量级上(2.08X不等硬度MOM的0.298mm3对比COM的0.172mm3)。这表示与传统CONSERVE PLUS MOM轴承相比，磨损显著地减少，与COM轴承相比，传统CONSERVE PLUS MOM轴承在磨损上显示出几乎十倍的增加(1.478mm3对比0.172mm3)。如上所述，陶瓷材料的脆性和较低的韧性使其难于制造在髋部表面重整过程中所用类型的大直径(例如，54mm)的陶瓷头。本发明通过允许制造与COM轴承的磨损率匹配的、同时基本上消除了有关陶瓷破裂的风险的髋部假体来解决这个问题，结果对于大尺寸髋部假体来说可能具有特殊的意义。
如图3所示，不等硬度金属轴承还展示出没有磨合阶段。因为如上所述，事先认可了MOM假体具有磨合阶段(例如参见WO 0117464A1报告的3.12±0.45mm3/106周期的磨合率；还参见Firkins)，所以这个结果也是意外的。如图3所示，Wright的CONSERVE PLUS MOM假体展示了大约3.1mm3的磨合磨损阶段，虽然预期不等硬度的MOM假体的磨合率会稍微减少，但磨合阶段的消除是一个惊人的结果。因为磨合阶段产生大量的金属颗粒，所以磨合阶段的消除对于接受假体植入的病人来说是非常重要的。
为什么图2和3表示的磨损数据是意外的，存在几个原因。MOM轴承组合的硬度比是COM系统的硬度比的一半，这暗示不等硬度的MOM轴承的磨损率将显著高于COM轴承的磨损率。MOM的硬度比是在小硬度范围(对于MOM轴承，大约为25-50Rc)上实现的，而COM假体是在大硬度范围上实现不等硬度的。CoCr合金与陶瓷相比具有较低的耐磨性。全部前述因素暗示不等硬度的MOM轴承的磨损率应当显著高于COM轴承的磨损率，结果本应与公布的关于MOM磨损率的结果一致。如上所述，虽然预期不等硬度轴承的磨损稍微降低，但减少量是惊人的。
另外，现有技术没有给出MOM假体(更不用说由当前批准用于假体的合金制造的假体轴承)可以实现与COM假体相当的磨损水平的任何启示。例如，在上述文章第1296页(上述讨论的)，Firkins报告了MOM假体的磨损率，该磨损率显示出比COM假体高100倍的磨损度。Firkins或别处没有建议MOM假体可以实现与COM假体相当的磨损水平。然而，惊人的是，图2中报告的结果与在上述文章第1294页Firkins报告的COM髋部假体的磨损率相似。由此，本发明的不等硬度轴承概念产生意外的结果。
尽管已经根据具体实施例对本发明进行了说明，但期望对本发明的另选和修改对本领域技术人员而言毫无疑问是显而易见的。因此，旨在将下列权利要求解释为覆盖落入本发明的真实精神和范围内的对本发明的全部另选和修改。

Claims (24)

1、一种矫形关节的假体，该假体包括：
第一组件，该第一组件具有由钴铬合金制成的软金属轴承表面，所述软金属轴承表面具有至少大约20Rc的硬度，
第二组件，该第二组件具有由钴铬合金制成的硬金属轴承表面，所述硬金属轴承表面具有比所述软金属轴承表面高至少大约15Rc的硬度，并且
所述软金属轴承表面和所述硬金属轴承表面构成为彼此关节连接。
2、根据权利要求1所述的假体，其中，所述硬金属轴承表面相对于所述软金属轴承表面的硬度比为至少大约1.5。
3、根据权利要求1所述的假体，其中，所述硬金属轴承表面相对于所述软金属轴承表面的硬度比处于大约1.5与大约3之间。
4、根据权利要求1所述的假体，其中，所述硬金属轴承表面比所述软金属轴承表面硬出不超过大约40Rc。
5、根据权利要求1所述的假体，其中，所述硬金属轴承表面具有大约40Rc与大约60Rc之间的硬度。
6、根据权利要求1所述的假体，其中，所述第一组件和所述第二组件中的一个具有大致凸状的轴承表面，而所述第一组件和所述第二组件中的另一个具有大致凹状的轴承表面，该大致凹状的轴承表面构成为在其中接收具有所述凸状的轴承表面的所述组件。
7、根据权利要求6所述的假体，其中，所述软金属轴承表面为凹状，而所述硬金属轴承表面为凸状。
8、根据权利要求1所述的假体，其中，所述软金属轴承表面的所述钴铬合金符合ASTM F75，而所述硬金属轴承表面的所述钴铬合金符合ASTM 1537。
9、根据权利要求8所述的假体，其中，所述硬金属轴承表面被热处理，以增加所述硬金属轴承表面的硬度。
10、一种髋关节的假体，该假体包括：
髋臼杯，该髋臼杯具有软金属轴承表面，所述软金属轴承表面由钴铬合金形成，
股骨组件，该股骨组件具有股骨头部，所述股骨头部具有硬金属轴承表面，所述硬金属轴承表面由钴铬合金形成，
所述硬金属轴承表面具有比所述软金属轴承表面高至少大约15Rc的硬度，并且
所述软金属轴承表面和所述硬金属轴承表面构成为彼此关节连接。
11、根据权利要求10所述的假体，其中，所述硬金属轴承表面相对于所述软金属轴承表面的硬度比为至少大约1.5。
12、根据权利要求10所述的假体，其中，所述硬金属轴承表面相对于所述软金属轴承表面的硬度比处于大约1.5与大约3.0之间。
13、根据权利要求10所述的假体，其中，所述硬金属轴承表面比所述软金属轴承表面硬出不超过大约40Rc。
14、根据权利要求10所述的假体，其中，所述硬金属轴承表面具有大约40Rc与大约60Rc之间的硬度。
15、根据权利要求10所述的假体，其中，所述软金属轴承表面的所述钴铬合金符合ASTM F75，而所述硬金属轴承表面的所述钴铬合金符合ASTM 1537。
16、根据权利要求15所述的假体，其中，所述硬金属轴承表面被热处理，以增加所述硬金属轴承表面的硬度。
17、一种髋部的假体，该假体包括：
球形轴承部件，该球形轴承部件在其中具有颈状凹部，
股骨茎部，该股骨茎部具有靠近其近端部的凹部，
模块化颈状部件，该模块化颈状部件的近端部构成为与所述球形轴承部件的所述颈状凹部固定地接合，所述模块化颈状部件的远端部构成为与所述茎部的所述凹部固定地接合，
髋臼植入物，该髋臼植入物具有构成为用于与所述球形轴承部件进行关节连接的凹状轴承表面，
其中，所述球形轴承部件和所述凹状轴承表面中的一个包括由钴铬合金制成的软金属轴承表面，该软金属轴承表面具有至少大约20Rc的硬度，并且
其中，所述球形轴承部件和所述凹状轴承表面中的所述另一个包括由钴铬合金制成的硬金属轴承表面，所述硬金属轴承表面具有比所述软金属轴承表面高至少大约15Rc的硬度，使得在所述球形部件与所述凹状轴承表面之间存在硬度比，由此减轻所述髋部的假体的磨损。
18、根据权利要求17所述的假体，其中，所述硬金属轴承表面相对于所述软金属轴承表面的硬度比为至少大约1.5。
19、根据权利要求17所述的假体，其中，所述硬金属轴承表面相对于所述软金属轴承表面的硬度比处于大约1.5与大约3之间。
20、根据权利要求17所述的假体，其中，所述硬金属轴承表面比所述软金属轴承表面硬出不超过大约40Rc。
21、根据权利要求17所述的假体，其中，所述硬金属轴承表面具有大约40Rc与大约60Rc之间的硬度。
22、根据权利要求17所述的假体，其中，所述球形轴承部件包括所述硬金属轴承表面，而所述凹状轴承部件包括所述软金属轴承表面。
23、根据权利要求17所述的假体，其中，所述软金属轴承表面的所述钴铬合金符合ASTM F75，而所述硬金属轴承表面的所述钴铬合金符合ASTM 1537。
24、根据权利要求17所述的假体，其中，所述硬金属轴承表面被热处理，以增加所述硬金属轴承表面的硬度。
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US7867281B2 (en) 2011-01-11
CN100551340C (zh) 2009-10-21
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AU2005295707B2 (en) 2012-03-08
EP1830750A1 (en) 2007-09-12
US20080200988A1 (en) 2008-08-21
KR101118800B1 (ko) 2012-03-20
KR20070083670A (ko) 2007-08-24
WO2006044576A1 (en) 2006-04-27
AU2005295707A1 (en) 2006-04-27
DE602005017937D1 (de) 2010-01-07
JP4499159B2 (ja) 2010-07-07
US20060085079A1 (en) 2006-04-20
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US7361194B2 (en) 2008-04-22
ATE449582T1 (de) 2009-12-15

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