CN105640672B - 膝假体系统 - Google Patents

膝假体系统 Download PDF

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CN105640672B
CN105640672B CN201610138299.6A CN201610138299A CN105640672B CN 105640672 B CN105640672 B CN 105640672B CN 201610138299 A CN201610138299 A CN 201610138299A CN 105640672 B CN105640672 B CN 105640672B
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tibial component
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D·D·奥格尔
D·P·费茨佩特里克
J·G·威斯
A·P·赖特
C·M·沃纳
S·A·黑兹布劳克
D·L·德芬鲍夫
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Abstract

本发明公开了一种用于全膝置换手术的膝假体系统，其包括多种尺寸明显不同的股骨部件、多种尺寸明显不同的固定胫骨部件、多种尺寸明显不同的活动胫骨部件、多个固定插入件和多个活动插入件。每个所述活动插入件的尺寸和形状确定为使之可与所述股骨部件之一最佳地匹配，并且可与所述活动胫骨部件中的任一个一起使用。每个所述固定插入件的尺寸和形状确定为使之可与所述股骨部件之一最佳地匹配，并且可与所述固定胫骨部件中的任一个一起使用。

Description

膝假体系统
本申请为2011年1月21日提交的专利申请“膝假体系统”（申请号：201110031384.X，申请人：德普伊产品公司）的分案申请。
背景技术
本公开总体上涉及外科手术装置和手术，更具体地讲，涉及可植入的全膝置换假体。
在全膝置换（TKR）手术中植入患者体内的被最广泛使用的类型的膝假体包括三个部件：金属股骨部件，其附着于股骨远端；金属胫骨部件（或托盘），其附着于近端胫骨；以及聚合物（UHMWPE）插入件（也称支承件或镶嵌物），其安装于股骨部件和胫骨部件之间。还可获得与这些膝假体的一些结合使用的各种类型的髌骨置换物。膝假体的两种类型为：用于当后交叉韧带不再有活力时使用的后稳定型（PS）假体以及（后）交叉韧带保留型（CR）膝假体。这两种类型的膝假体的每一种可设置为固定支承膝假体，其中插入件不相对于胫骨部件运动，或者设置为活动支承膝假体，其中插入件在胫骨部件的光滑平台上旋转。使用活动插入件还是固定插入件很大程度上取决于患者的膝韧带和其它软组织的状况。
膝假体系统可包括多种尺寸的股骨、胫骨和插入件部件，以适应全世界TKR患者群体中患者解剖结构的不同。膝假体系统的设计需要在许多重要因素间权衡，所述因素涉及（仅例举一些）运动性能、临床结果、植入物耐久性、成本和易用性。关于膝假体的运动性能和寿命二者的重要考虑是股骨部件支承表面和插入件支承表面之间的型合度。
研究人员通常将冠状面或矢状面的型合度表征为股骨部件的股骨髁的凸面半径与相接的插入件表面的凹面半径的比率。型合率为零代表平坦的插入件表面，对应于高负载下的非常高的接触应力。型合率为0.99代表高型合度，通常对应于高接触面积、相对低的接触应力，以及随之而来的插入件聚乙烯表面的磨损率降低。
研究人员已经发现冠状面的型合度对假体寿命的影响可能会大于矢状面的型合度对假体寿命的影响。例如，在Kuster等人的论文“The effects of conformity and loadin total knee replacement（在全膝置换中型合度和负载的影响）”(Clinical Orthopaedics and Related Research（临床整形外科和相关研究），第375期、302-12页，2000年6月)中，作者发现压缩表面应力、剪切应力和von Mises应力受到型合率改变的影响，而受负载变化的影响较小。在更新近的Berend等人的论文“Effects of coronal planeconformity on tibial loading in TKA: a comparison of AGC flat versusconforming articulations（在TKR中冠状面型合度对胫骨负载的影响：AGC平坦与型合关节连接的比较）”(Surgical Technology Int.（外科手术技术），第18期，第207-212页，2009年)中，作者研究了型合度对患者的近端胫骨负载的影响。近端胫骨的不合适的负载可导致胫骨部件在胫骨中的无菌性松动，并最终导致假体失效从而需要修复手术。作者发现冠向凹形扭曲部件造成胫骨前内侧的应变增大，同时造成胫骨后侧的应变显著减小。他们还发现在型合与平坦关节连接中近端胫骨应变减小并集中。
但是，本领域中周知的是，非常高的型合度也可引起（例如）插入件表面的不良负载状况，或者引起对股骨部件的过度约束，从而抑制了对于关节性能和患者舒适度而言重要的关节运动。因此，只要应力低于插入件材料的屈服强度，则用接触面积的中间值来设计可以是最佳的，以达成关节松弛和型合率的最佳组合。
全世界的TKR患者群体的患者解剖结构不同，这使膝假体设计者面对的挑战复杂化。具有较小股骨的体型较小的患者明显需要较小的膝假体。与用于体型大的患者的大股骨部件相比，小股骨部件的股骨部件内外髁各自具有更小的冠状半径。为了保持合适的型合率以及包括髁间距在内的其它几何关系，小股骨部件必须与合适尺寸的插入件匹配。然而，除了大范围的患者尺寸之外，股骨和胫骨之间的尺寸比例也变化很大。例如，对于给定尺寸的近端胫骨，一些患者具有比其它患者更大的股骨远端。在这种情况下，当使用目前可用的膝假体系统时，医生可能需要选择植入与股骨稍微不匹配而与插入件匹配的股骨部件，或者与股骨匹配而与插入件稍微不匹配的股骨部件。
因此，根据上述考虑，需要这样一种膝假体系统，其允许医生选择与特定患者的股骨尺寸相符的股骨部件、与胫骨尺寸相符的胫骨部件以及与股骨部件最佳匹配并与胫骨部件相容的插入件。这种膝假体系统应当包括固定类型和活动类型的假体这二者，并用于CR和PS这两种手术。此外，所述系统应当顾及全世界患者群体的患者解剖结构的各种变化。
除了提供最佳匹配的膝假体部件之外，还存在保持和降低膝假体系统的成本和复杂度的持续需要。膝假体系统可包括多种尺寸的、各用于左右膝的股骨部件、胫骨部件和插入件，以适应患者解剖结构和状况的变化。此外，每个插入件可具有多种厚度，从而医生可选择引起合适关节张力的一种。因此，膝假体制造商必须提供代表大量不同尺寸组合的非常大的部件库存，以顾及世界范围的患者群体。因此，需要允许部件可互换的改进的膝假体系统，以用最少量的部件得到必要的尺寸组合。
膝假体系统设计过程中的另一考虑是对于PS股骨部件植入的骨预备。PS和CR股骨部件这二者均有一对分离的髁，所述髁与股骨远端的自然髁在一定程度上相似。对于PS股骨部件，位于髁之间的盒状物（或髁间窝）包括与PS插入件上的棘突相互作用的特征。PS股骨部件的植入需要在股骨远端切割凹槽以接纳所述盒状物。在一些当前的膝假体系统中，对于所有的PS股骨部件尺寸来说，盒状物的尺寸都是相同的，从而需要在股骨远端切割相同尺寸的凹槽，即使对于较小的股骨也是一样。然而，如果可能的话，最好在为了附连股骨部件的股骨的预备期间保存自然骨骼。因此，还需要这样一种膝假体系统，其在解决前述需要的同时，每个PS股骨部件具有其尺寸相对于股骨尺寸按比例确定的盒状物。
膝假体系统设计过程中的另一考虑是为胫骨部件植入而进行的骨预备。目前可获得的活动和固定的TKR假体系统包括一定范围内的解剖尺寸的胫骨部件。对于这些系统中的一些，用于特定尺寸的活动TKR假体的胫骨部件具有与同样尺寸的固定TKR假体的构造不同的构造。具体地讲，支持固定支承插入件的平台的形状可以不同于支持活动支承插入件的平台的形状。这可导致切除的胫骨平台表面的覆盖范围发生小的（但可能是显著的）差异。虽然不尽理想，医生可通过选择较大尺寸的胫骨部件来获得期望的胫骨覆盖范围。更理想的是，设有活动和固定胫骨部件的TKR系统具有针对与周围组织的相互作用、运动性能等而优化的通用平台轮廓形状。
另外，目前可获得的TKR系统设有这样的胫骨部件，其具有可变长度的柄部以适应不同胫骨状况。此外，活动胫骨部件柄部的构造可以不同于固定胫骨部件柄部的构造。接着，这类系统要求有大量不同的扩孔工具用于各外科手术。优选的TKR系统会包括具有不同长度柄部的活动和固定胫骨部件，但是不要求用于预备胫骨的若干个不同的扩孔工具。这还为医生提供选择合适类型的胫骨部件的术中灵活度，同时减少在外科手术中需备用的器械数量。
附图说明
虽然本说明书以权利要求书进行总结，其中特别指出并明确主张本发明的权利，但以下的说明和附图将进一步说明受权利要求书保护的本发明的一些非限制性实例。除非另外指明，相同的附图标记指代相同的要素。
图1是固定CR假体110的透视图。
图2是CR股骨部件20的透视图，所述CR股骨部件是图1所示的固定CR假体110和图9所示的活动CR假体130的一部分。
图3是固定CR插入件50的透视图，所述固定CR插入件是图1所示的固定CR假体110的一部分。
图4是固定胫骨部件70的透视图，所述固定胫骨部件是图1所示的固定CR假体110和图5所示的固定PS假体120的一部分。
图5是固定PS假体120的透视图。
图6是PS股骨部件10的透视图，所述PS股骨部件是图5所示的固定PS假体120和图13所示的活动PS假体140的一部分。
图7是固定PS插入件30的透视图，所述固定PS插入件是图5所示的固定PS假体120的一部分。
图8是固定胫骨部件70的透视图，所述固定胫骨部件也在图4中示出。
图9是活动CR假体130的透视图。
图10是CR股骨部件20是透视图，所述CR股骨部件也在图2中示出。
图11是活动CR插入件60的透视图，所述活动CR插入件是图9所示的活动CR假体130的一部分。
图12是活动胫骨部件80的透视图，所述活动胫骨部件是图13所示的活动CR假体130和活动PS假体140的一部分。
图13是活动PS假体140的透视图。
图14是PS股骨部件10的透视图，所述PS股骨部件也在图10中示出。
图15是活动PS插入件40的透视图，所述活动PS插入件是图13所示的活动PS假体140的一部分。
图16是活动胫骨部件80的透视图，所述活动胫骨部件也在图12中示出。
图17是表示按多种尺寸组合进行配置的膝假体系统100的图表，各假体在图1、5、9和13中示出。
图18是尺寸1的活动胫骨部件的前视图。
图19是尺寸3的活动胫骨部件的前视图。
图20是尺寸7的活动胫骨部件的前视图。
图21是尺寸9的活动胫骨部件的前视图。
图22A是图18的尺寸一的活动胫骨部件的俯视图。
图22B是尺寸1的固定胫骨部件的俯视图。
图23A是图19的尺寸3的活动胫骨部件的俯视图。
图23B是尺寸3的固定胫骨部件的俯视图。
图24A是图20的尺寸7的活动胫骨部件的俯视图。
图24B是尺寸7的固定胫骨部件的俯视图。
图25A是图21的尺寸9的活动胫骨部件的俯视图。
图25B是尺寸9的固定胫骨部件的俯视图。
具体实施方式
在本公开中，术语“前、后、外、内”通常分别指代外科手术患者的前、后、外侧和中线，虽然文中还对于装置使用这些术语。图1示出了针对这些术语以及术语“下、上”的指向箭头。另外，我们有意在提及“医生”和“使用者”时也包括在外科手术中可帮助医生的任何人。
以下文献全文以引用方式并入本文中。
美国专利7,628,818，标题为“Fixed-Bearing Knee Prosthesis HavingInterchangeable Components（具有可互换部件的固定支承膝假体）”，由Hazebrouck等人(以下称“Hazebrouck”)于2007年9月28日提交，并于2009年4月2日公布。
美国专利申请No. 12/165582，标题为“Posterior-Stabilized OrthopaedicProsthesis（后稳定型整形外科假体）”，由Wyss等人(以下称为“Wyss”)于2008年6月30日提交。
Hazebrouck公开了固定支承膝假体系统，其中不同尺寸的插入件各自可与每种尺寸的胫骨部件相容，使得医生可选择其尺寸针对患者胫骨适当确定的胫骨部件以及与股骨部件匹配的插入件。
Wyss公开了这样一种膝假体系统，所述膝假体系统具有多种尺寸明显不同的PS（固定或活动）插入件，所述插入件具有从下表面向上延伸的棘突。所述棘突的后侧具有凹陷凸轮面和突起凸轮面。每个PS股骨部件具有一对间隔开的髁，所述髁限定具有后凸轮的髁间窝。后凸轮包括凹陷凸轮面和突起凸轮面。在第一阶段的屈曲过程中，后凸轮的凹陷凸轮面接触棘突的突起凸轮面，在第二阶段的屈曲过程中，后凸轮的突起凸轮面接触棘突的凹陷凸轮面。
图1-16示出了在图17中示出的膝假体系统100的各部件。这些部件中的每一种均可有多种尺寸，并且可如下所述地匹配到一起，从而为医生提供大量的尺寸组合。通过利用膝假体系统100，医生可针对大的患者群体中的每个患者选择正确匹配患者的股骨和胫骨这二者的尺寸组合。也就是说，股骨部件的尺寸被定得明显不同以配合股骨，且胫骨部件的尺寸被定得明显不同以配合胫骨，并且膝假体的部件被最佳地匹配以避免对关节性能采取折中办法。
膝假体系统100的尺寸明显不同的股骨和胫骨部件的一个特征是每个部件与所述部件将要连接于其上的特定尺寸的骨骼的相称性。通常，部件的尺寸比例改变，但形状不变。例如，股骨部件可具有尺寸按比例确定的髁间距离，使得大的股骨部件的髁间距离按比例地大于小的股骨部件的髁间距离。相似地，大的胫骨部件可具有与小的胫骨部件相比在比例上更宽和更深的后缺口。
图1是交叉韧带保留型固定支承膝假体110的透视图，其也被称作固定CR假体110，其包括CR股骨部件20（图10）、固定CR插入件50（图11）和固定胫骨部件70（图12）。固定CR假体110可与在图1中示出的Hazebrouck的膝假体相同或相似。Hazebrouck公开了多种尺寸明显不同的插入件（或支承件）中的任一个可固定到多种尺寸明显不同的胫骨部件（或托盘）中的任一个。因此，可以针对每个股骨部件的尺寸改善插入件的关节连接表面的几何形状和其它特征。这种互换能力也允许在设计一系列股骨部件时更少地增加尺寸。CR股骨部件20包括内髁24和外髁26，这二者在固定CR支承件50的上表面56上关节连接。固定胫骨部件70的前支墩(buttress) 75和后支墩76将CR插入件50固定地保持到固定胫骨部件70上，使得CR插入件50的下表面54置于固定胫骨部件70的平台72上。固定胫骨部件70还包括插入到通过外科手术预备的近端胫骨中的柄部74。
图5是后稳定型固定支承膝假体120，其也称固定PS假体120，其包括PS股骨部件10、固定PS插入件30和固定胫骨部件70。PS股骨部件10可与在图1中示出的Wyss的股骨部件相同或相似。PS股骨部件10包括内髁14和外髁16，这二者在固定PS插入件30的上表面36上关节连接。PS股骨部件10还包括位于内髁14和外髁16之间的盒状物32。盒状物32包住可操作地与固定PS插入物30的棘突32接合的后凸轮和前凸轮（二者均不可见），如Wyss所述。固定胫骨部件70的前支墩75和后支墩776可保持PS插入件30，使得PS插入件30的下表面34坐落在固定胫骨部件70的平台72上。
图9是交叉韧带保留型活动支承膝假体130的透视图，其也称活动CR假体130，其包括CR股骨部件20（前文已参照图2进行了描述）、活动CR支承插入件60和活动胫骨部件80。CR股骨部件20的内髁24和外髁26在活动CR插入件60的上表面66上关节连接。活动CR插入件60的下表面64相对于活动胫骨部件80的平台82关节连接。柱68从下表面64向下延伸并可旋转地插入活动胫骨部件80的中空柄部84。
图13是后稳定型活动支承膝假体140，其也称活动PS假体140，其包括PS股骨部件10（前文已参照图6进行了描述）、活动PS插入件40和活动胫骨部件80（前文已参照图12进行了描述）。活动PS插入件40包括可与图7所示的固定PS插入件30的上表面36和棘突32相同的上表面46和棘突42。活动PS插入件40还包括可与图3所示的固定CR插入件50的下表面54相同的下表面34。
图17是表示包括图1、图5、图9和图13中的各膝假体的一体式膝假体系统40的图表。各部件10、20、30、40、50、60、70和80可按照多种尺寸（例如，十种尺寸）设置，以适应患者群体大范围变化的解剖结构。这些部件可如下匹配到一起：
PS股骨部件10的任一尺寸可与固定PS插入件30或活动插入件40的任一尺寸匹配。
CR股骨部件20的任一尺寸可与固定CR插入件50或活动CR插入件60的任一尺寸匹配。
固定胫骨部件70的任一尺寸可与固定PS插入件30或固定CR插入件50的任一尺寸匹配。
活动胫骨部件80的任一尺寸可与活动PS插入件40或活动CR插入件60的任一尺寸匹配。
另外，各插入件30、40、50和60的每种尺寸可以多种厚度提供。
如前所述，患者的解剖结构不仅在尺寸方面有变化，而且在股骨/胫骨的尺寸比例方面有变化。利用TKR手术的历史数据，可确定为全世界群体内的大多数患者所需的尺寸组合。例如，可用尺寸定得显然不同的膝假体适应对于差不多所有患者中的每个患者的股骨和胫骨这二者的配合，实现方式如下：通过将股骨部件与大两种尺寸或小两种尺寸范围内的胫骨部件配对。“尺寸3”的CR股骨部件可与“尺寸1、2、3、4或5”的（固定或活动）胫骨部件中的任一个一起使用，而“尺寸1”的CR股骨部件可与“尺寸1、2或3”的（固定或活动）胫骨部件中的任一个一起使用。相似地，“尺寸5”的固定胫骨部件可与“尺寸3、4、5、6或7”的（CR或PS）固定插入件中的任一个一起使用。通过利用膝假体系统100，这些配对中的每一对使股骨部件能够与插入件最佳地匹配，以保持理想的几何关系。
表1列出了示例性实施例的膝假体系统100的部件。表2列出了针对表1列出的各股骨部件提供的股骨部件尺寸。表2还针对每个股骨部件尺寸给出：对于表1中列出的各插入件相容的插入件尺寸，以及对于表1中列出的各胫骨部件相容的胫骨部件尺寸。
表1：膝假体系统部件
部件 尺寸的个数 厚度的个数 部件的个数
PS股骨(右) 14 --- 14
PS股骨(左) 14 --- 14
CR股骨(右) 14 --- 14
CR股骨(左) 14 --- 14
活动PS插入件 10 9 90
固定PS插入件 10 9 90
活动CR插入件 10 8 80
固定CR插入件 10 8 80
活动胫骨 10 --- 10
固定胫骨 10 --- 10
总计 416
表2：相容的尺寸
股骨部件尺寸 插入件尺寸 胫骨部件尺寸
1 1 1, 2, 3
2 2 1, 2, 3, 4
3 3 1, 2, 3, 4, 5
3N 3 1, 2, 3, 4, 5
4 4 2, 3, 4, 5, 6
4N 4 2, 3, 4, 5, 6
5 5 3, 4, 5, 6, 7
5N 5 3, 4, 5, 6, 7
6 6 4, 5, 6, 7, 8
6N 6 4, 5, 6, 7, 8
7 7 5, 6, 7, 8, 9
8 8 6, 7, 8, 9, 10
9 9 7, 8, 9, 10
10 10 8, 9, 10
表1和表2中示出的膝假体系统100的实施例提供了2176种独特的假体部件组合。在这些组合的每一个中，股骨部件的尺寸被定得明显不同以配合患者的股骨，同时与插入件最佳匹配，并且胫骨部件的尺寸被定得明显不同以配合患者的胫骨，同时与插入件相容。结果，膝假体系统100可让医生不用对世界患者群体中的每个患者在运动性能和植入关节寿命之间进行折中。
如前文指出，髌骨部件也可与膝假体组合地提供以用于植入。髌骨部件可以被提供多种尺寸。适于用在膝假体系统100中的髌骨植入物的实例为可得自DePuyOrthopaedics, Inc. (Warsaw, IN)的“P.F.C. Sigma髌骨植入物”。膝假体系统100的另一实施例还可包括两种独特类型的髌骨部件，每个类型有五种尺寸，从而允许医生从21,760种独特的部件组合中进行选择。在这些组合的每个中，股骨部件的尺寸被定得明显不同以匹配患者的股骨，同时与插入件最佳匹配，并且胫骨部件的尺寸被定得明显不同以配合患者的胫骨，同时与插入件相容。
膝假体系统100允许医生选择一种用于植入到患者体内的膝假体部件的组合，其中所述部件的尺寸被定得明显不同以配合患者的股骨和胫骨，同时还被最佳匹配，以避免对重建关节的性能采取折中办法。膝假体系统100还提供PS股骨部件，既然（固定或活动）PS插入件与每个PS股骨部件匹配，所述PS股骨部件的尺寸就按比例确定为适合股骨。膝假体系统100还可降低必需的植入部件库存的成本和复杂度，以顾及世界范围的患者群体，这主要是由于部件的可互换性。
如前文阐明，需要这样一种膝假体系统，其包括具有不同长度的柄部的活动和固定胫骨部件，但不要求用于预备胫骨的若干个不同的扩孔工具。如图17所示，活动胫骨部件80和固定胫骨部件70可具有用于每种解剖尺寸的大致相似或相同的外尺寸和构造，使得医生能够利用相同的器械按照大致相同的方式预备近端胫骨。这还允许医生甚至在通过外科手术预备好近端胫骨之后植入任一种类型的胫骨部件。
图18、19、20和21示出了膝假体系统100的四种代表性尺寸的活动胫骨部件80。例如，膝假体系统100可具有十种尺寸的固定胫骨部件70和十种尺寸的活动胫骨部件80，如表2所示。图18是尺寸1的活动胫骨部件150的前视图，其具有尺寸1的平台152、尺寸1的柄部154和在柄部154和平台152之间延伸的一对对置的龙骨151、153。柄部154具有长度为“E”的远端部分156和长度为“A”的近端部分158。
图19是尺寸3的活动胫骨部件160的前视图，其具有尺寸3的平台162、尺寸3的柄部164和一对对置的龙骨161、163。柄部164具有长度同样为“E”的远端部分166和长度为“B”的近端部分168。
图20是尺寸7的活动胫骨部件170的前视图，其具有尺寸7的平台172、尺寸7的柄部174和一对对置的龙骨171、173。柄部174具有长度同样为“E”的远端部分176和长度为“C”的近端部分178。
图21是尺寸9的活动胫骨部件180的前视图，其具有尺寸9的平台182、尺寸9的柄部184和一对对置的龙骨181、182。柄部184具有长度同样为“E”的远端部分186和长度为“D”的近端部分188。
如图18、19、20和21所示，长度“D”大于长度“C”，长度“C”大于长度“B”，长度“B”大于长度“A”。通常，增加的柄部长度对应于柄部近端部分的增加长度，而远端部分的长度保持不变。
远端部分156、166、176和186还可具有相同的大致锥形的形状。近端部分158、168、178和188可具有大致相同的截头圆锥形形状，并且主要在长度上发生变化。龙骨151、153、161、163、171、173、181、183可具有大致相似的构造和取向。本领域技术人员应当清楚，医生可使用相同的扩孔工具来在近端胫骨形成期望深度的腔，以接纳各种尺寸的柄部154、164、174和184中的任一种。因为多种尺寸明显不同的固定胫骨部件中每个的外部尺寸和构造可与所述多种尺寸明显不同的活动胫骨部件中对应的一个大致相似或相同，所以对于给定尺寸的任一所述固定或活动胫骨部件来说近端胫骨的外科手术预备可相同，并且对于固定和活动胫骨部件这二者的所有尺寸来说，需要的器械可以相同。
如前文阐明，还希望全膝置换系统包括具有通用的平台轮廓或“占有面积”的活动和固定胫骨部件，所述平台轮廓或“占有面积”对于胫骨平台的覆盖范围、与周围组织的交互作用、运动性能和其它因素进行优化。图22A、22B、23A、23B、24A、24B、25A和25B示出了膝假体系统100的四种代表性尺寸的固定和活动胫骨部件的俯视（平面）图。如前所述，膝假体部件100可具有十种尺寸的固定胫骨部件70和十种尺寸的活动胫骨部件80，如表2所示。
图22A示出了尺寸1的活动胫骨部件150，其具有与图22B所示的尺寸1的固定胫骨部件250的平台252的“占有面积”或轮廓相似的“占有面积”或轮廓的平台152。
图23A示出了尺寸3的活动胫骨部件160，其具有与图23B所示的尺寸1的固定胫骨部件260的平台262的轮廓相似的轮廓的平台162。
图24A示出了尺寸7的活动胫骨部件170，其具有与图24B所示的尺寸1的固定胫骨部件270的平台272的轮廓相似的轮廓的平台172。
图25A示出了尺寸9的活动胫骨部件180，其具有与图25B所示的尺寸1的固定胫骨部件280的平台282的轮廓相似的轮廓的平台182。
对于每种尺寸的胫骨部件，针对用于特定解剖尺寸的活动和固定胫骨部件这二者来说，平台轮廓（从顶部沿着柄部轴线的方向看）是相同的。当在活动和固定假体之间选择时，不需要改变胫骨部件尺寸来获得相同的胫骨平台覆盖范围。通用平台形状的另一优点是可在两种胫骨部件的制造过程中使用相同的造模工具或所述工具的一部分，使得部件成本降低。
以上说明并描述了各种实施例和实例。但是，本领域普通技术人员可修改本文描述的方法和装置而不脱离本发明的总体概念。例如，附图的具体材料、尺寸和比例应当被理解为非限制性实例。因此，以下权利要求的范围不应被理解为受限于说明书和附图中显示和描述的结构、材料或行为的细节。

Claims (18)

1.一种用于交叉韧带保留型（CR）和后稳定型（PS）全膝置换手术的膝假体系统，其包括：
a. 多个不同尺寸的CR股骨部件，每个CR股骨部件都具有内髁表面和外髁；
b. 多个不同尺寸的PS股骨部件，每个PS股骨部件都具有内髁表面和外髁表面；
c. 多个不同尺寸的固定胫骨部件；
d. 多个不同尺寸的活动胫骨部件；
e. 多个不同尺寸的CR活动插入件，每个CR活动插入件都具有构造成与一个尺寸的CR股骨部件的内髁表面铰接的内支承表面和构造成与相同尺寸的CR股骨部件的外髁表面铰接的外支承表面，其中每个尺寸的CR活动插入件都能够安装在大两种尺寸或小两种尺寸范围内的活动胫骨部件上；
f. 多个不同尺寸的CR固定插入件，每个CR固定插入件都具有构造成与一个尺寸的CR股骨部件的内髁表面铰接的内支承表面和构造成与相同尺寸的CR股骨部件的外髁表面铰接的外支承表面，其中每个尺寸的CR固定插入件都能够安装在大两种尺寸或小两种尺寸范围内的固定胫骨部件上；
g. 多个不同尺寸的PS固定插入件，每个PS固定插入件都具有构造成与一个尺寸的PS股骨部件的内髁表面铰接的内支承表面和构造成与相同尺寸的PS股骨表面的外髁表面铰接的外支承表面，其中每个尺寸的PS固定插入件都能够安装在大两种尺寸或小两种尺寸范围内的固定胫骨部件上；以及
h. 多个PS活动插入件，每个PS活动插入件都具有构造成具有与一个尺寸的PS股骨部件的内髁表面铰接的内支承表面和构造成与相同尺寸的PS股骨部件的外髁表面铰接的外支承表面，其中每个尺寸的PS活动插入件都能够安装在大两种尺寸或小两种尺寸范围内的活动胫骨部件上，
i. 其中每个胫骨部件都具有平台和从所述平台向远端延伸的柄部，每个柄部都具有远端部分和近端部分；所述远端部分和所述近端部分具有不同的形状，每个尺寸的胫骨部件的所述柄部的所述远端部分都具有相同的长度和相同的大致锥形的形状，且每个尺寸的胫骨部件的所述柄部的所述近端部分具有不同的长度；
其中，多个不同尺寸的固定胫骨部件的每一个都具有平台，前支墩和后支墩从所述平台延伸，用于保持多个PS固定插入件的任意一个以及多个CR固定插入件的任意一个；并且每个PS固定插入件都具有下表面，下表面带有限定在其中的凹陷，用于接纳大两种尺寸或小两种尺寸范围内的固定胫骨部件的所述前支墩和后支墩，并且每个CR固定插入件都具有下表面，下表面带有限定在其中的凹陷，用于接纳大两种尺寸或小两种尺寸范围内的固定胫骨部件的所述前支墩和后支墩。
2.根据权利要求1所述的膝假体系统，其特征在于：所述多个PS固定插入件的每一个和所述多个PS活动插入件的每一个都具有下表面和由该下表面向上延伸的棘突，所述棘突具有包括凹陷凸轮面和突起凸轮面的后侧，并且每个PS股骨部件的后凸轮都包括凹陷凸轮面和突起凸轮面，其中在第一阶段的屈曲过程中所述后凸轮的凹陷凸轮面接触所述棘突的突起凸轮面，并且在第二阶段的屈曲过程中，所述后凸轮的突起凸轮面接触所述棘突的凹陷凸轮面。
3.根据权利要求2所述的膝假体系统，其特征在于：多个不同尺寸的PS股骨部件的每一个都包括髁间窝，并且其中每个不同尺寸的PS股骨部件的髁间窝都相对于股骨尺寸按比例地确定尺寸和成形，以便配合患者腿骨的特定解剖尺寸和形状。
4.根据权利要求1-3的任一项所述的膝假体系统，其特征在于：还包括多个髌骨部件，其中的任一个都能够与多个不同尺寸的CR股骨部件的任一个以及与多个不同尺寸的PS股骨部件的任一个一起使用。
5.根据权利要求1-3的任一项所述的膝假体系统，其特征在于：多个CR固定插入件的每一个都具有与所述多个CR固定插入件的其他的插入件不同的厚度，多个CR活动插入件的每一个都具有与所述多个CR活动插入件的其他的插入件不同的厚度，多个PS固定插入件的每一个都具有与所述多个PS固定插入件的其他的插入件不同的厚度，而多个PS活动插入件的每一个都具有与所述多个PS活动插入件的其他的插入件不同的厚度。
6.根据权利要求1-3的任一项所述的膝假体系统，其特征在于：用于固定和活动胫骨部件的特定解剖尺寸的柄部具有大致相同的外部尺寸和构造，使得对于用于特定解剖尺寸的每一个固定和活动胫骨部件所需的近端胫骨的手术准备大致相同。
7.一种用于交叉韧带保留型（CR）和后稳定型（PS）全膝置换手术的膝假体系统，其包括：
a. 多个不同尺寸的CR股骨部件；
b. 多个不同尺寸的PS股骨部件；
c. 多个不同尺寸的固定胫骨部件；
d. 多个不同尺寸的活动胫骨部件；
e. 多个不同尺寸的CR活动插入件，每个CR活动插入件的尺寸和形状都设置成使得每个CR活动插入件都能够最优地匹配其中一个所述CR股骨部件；
f. 多个不同尺寸的聚合物CR固定插入件，每个CR固定插入件都具有铰接表面，所述铰接表面的尺寸和形状设置成使得每一个都能够最优地匹配其中一个CR股骨部件；
g. 多个不同尺寸的聚合物PS固定插入件，每个PS固定插入件都具有铰接表面，所述铰接表面的尺寸和形状设置成使得每一个都能够最优地匹配其中一个PS股骨部件；
h. 多个PS活动插入件，每个PS活动插入件的尺寸和形状都设置成使得每一个都能够最优地匹配其中一个PS股骨部件；
其中：
所述固定胫骨部件具有用于将选定的PS固定插入件或CR固定插入件以及选定的其中一个固定胫骨部件固定在一起的安装结构；并且其中
每个胫骨部件都具有平台和从所述平台向远端延伸的柄部，每个柄部都具有远端部分和近端部分，所述远端部分和所述近端部分具有不同的形状，每个尺寸的胫骨部件的柄部的远端部分都具有相同的长度和相同的大致锥形的形状，并且每个尺寸的胫骨部件的柄部的近端部分都具有不同的长度；
其中，多个不同尺寸的固定胫骨部件的每一个都具有平台，前支墩和后支墩从所述平台延伸，用于保持多个PS固定插入件的任意一个以及多个CR固定插入件的任意一个；并且每个PS固定插入件都具有下表面，下表面带有限定在其中的凹陷，用于接纳大两种尺寸或小两种尺寸范围内的固定胫骨部件的所述前支墩和后支墩，并且每个CR固定插入件都具有下表面，下表面带有限定在其中的凹陷，用于接纳大两种尺寸或小两种尺寸范围内的固定胫骨部件的所述前支墩和后支墩。
8.根据权利要求7所述的膝假体系统，其特征在于：还包括多个髌骨部件，任一个髌骨部件都能够与多个不同尺寸的CR股骨部件的任一个一起使用，并与多个不同尺寸的PS股骨部件的任一个一起使用。
9.根据权利要求7或权利要求8所述的膝假体系统，其特征在于：每个不同尺寸的PS股骨部件都包括髁间窝，并且所述髁间窝相对于股骨尺寸按比例地确定尺寸和成形，以便配合患者腿骨的特定解剖尺寸和形状。
10.根据权利要求7或权利要求8所述的膝假体系统，其特征在于：用于固定和活动胫骨部件的特定解剖尺寸的柄部具有大致相同的外部尺寸和构造，使得对于用于特定解剖尺寸的每一个固定和活动胫骨部件所需的近端胫骨的手术准备大致相同。
11.一种用于交叉韧带保留型（CR）和后稳定型（PS）全膝置换手术的膝假体系统，其包括：
a. 多个固定CR膝假体；
b. 多个活动CR膝假体；
c. 多个固定PS膝假体；
d. 多个活动PS膝假体；
其中每个固定的假体代表一个尺寸组合并且包括多个不同尺寸的股骨部件的其中一个，多个不同尺寸的胫骨部件的其中一个，以及多个不同尺寸的插入件的其中一个，且每个假体处于性能最优地匹配与所述股骨部件的尺寸相匹配的所述插入件的尺寸，以及独立于所述股骨部件的尺寸的所述胫骨部件的尺寸，从而所述膝假体系统能够用于患者群体内各种解剖结构；以及
其中：
所述固定CR膝假体和所述固定PS膝假体的所述胫骨部件包括具有支墩的平台；
每个尺寸的胫骨部件都具有不同的尺寸比例；
所述固定CR膝假体和所述固定PS膝假体的所述插入件并且包括具有限定在其中的凹陷的下表面，所述凹陷用于接纳所述固定CR膝假体和所述固定PS膝假体的所述胫骨部件的支墩；
所述固定CR膝假体和固定PS膝假体的每个尺寸的插入件都具有不同的尺寸比例，
所述固定CR膝假体和所述固定PS膝假体的每个插入件都能够与所述固定CR膝假体和所述固定PS膝假体的大两种尺寸或小两种尺寸范围内的所述胫骨部件安装在一起；并且其中
每个胫骨部件都具有平台和从所述平台向远端延伸的柄部，每个柄部都具有远端部分和近端部分，所述远端部分和所述近端部分具有不同的形状，每个尺寸的胫骨部件的所述柄部的所述远端部分具有相同的长度和相同的大致锥形的形状，并且每个尺寸的胫骨部件的所述近端部分具有不同的长度；
固定胫骨部件的前支墩和后支墩将CR插入件固定地保持到固定胫骨部件上，使得CR插入件的下表面置于固定胫骨部件的平台上；固定胫骨部件的前支墩和后支墩保持PS插入件，使得PS插入件的下表面坐落在固定胫骨部件的平台上。
12.一种用于交叉韧带保留型（CR）和后稳定型（PS）全膝置换手术的膝假体系统，其包括：
a. 多个不同尺寸的CR股骨部件；
b. 多个不同尺寸的PS股骨部件；
c. 多个不同尺寸的固定胫骨部件和多个不同尺寸的活动胫骨部件；
d. 多个不同尺寸的CR固定插入件；
e. 多个不同尺寸的PS固定插入件；
f. 多个不同尺寸的CR活动插入件；以及
g. 多个不同尺寸的PS活动插入件；
其中：
每个尺寸的CR股骨部件都与任一尺寸的CR固定插入件相容；
每个尺寸的CR股骨部件都与任一尺寸的CR活动插入件相容；
每个尺寸的PS股骨部件都与任一尺寸的PS固定插入件相容；
每个尺寸的PS股骨部件都与任一尺寸的PS活动插入件相容；
每个尺寸的固定胫骨部件都具有不同的尺寸比例；
每个尺寸的CR固定插入件都具有不同的尺寸比例；
每个尺寸PS固定插入件都具有不同的尺寸比例；
胫骨部件和插入件具有互补的安装结构，使得每个尺寸的CR固定插入件都能够安装在大两种尺寸或小两种尺寸范围内的固定胫骨部件上，每个尺寸的CR活动插入件都与大两种尺寸或小两种尺寸范围内的活动胫骨部件相容，每个尺寸的PS固定插入件都能够安装在大两种尺寸或小两种尺寸范围内的固定胫骨部件上并且每个尺寸的PS活动插入件都与大两种尺寸或小两种尺寸范围内的活动胫骨部件相容；并且其中
每个胫骨部件都具有平台和从所述平台向远端延伸的柄部，每个柄部都具有远端部分和近端部分，所述远端部分和所述近端部分具有不同的形状，每个尺寸的胫骨部件的柄部的远端部分具有相同的长度和相同的大致锥形的形状，而每个尺寸的胫骨部件的柄部的近端部分具有不同的长度；
固定胫骨部件的前支墩和后支墩将CR插入件固定地保持到固定胫骨部件上，使得CR插入件的下表面置于固定胫骨部件的平台上，且固定胫骨部件的前支墩和后支墩保持PS插入件，使得PS插入件的下表面坐落在固定胫骨部件的平台上。
13.根据权利要求12所述的膝假体系统，其特征在于，用于固定和活动胫骨部件的特定解剖尺寸的柄部具有大致相同的外部尺寸和构造，使得对于用于特定解剖尺寸的每一个固定和活动胫骨部件所需的近端胫骨的手术准备大致相同。
14.根据权利要求12或权利要求13所述的膝假体系统，其特征在于，多个不同尺寸的固定胫骨部件的每一个都具有前支墩和后支墩由其延伸的平台，用于保持多个PS固定插入件的任一个和多个CR固定插入件的任一个。
15.根据权利要求12或权利要求13所述的膝假体系统，其特征在于，多个PS固定插入件的每一个和多个PS活动插入件的每一个都具有下表面和由该下表面向上延伸的棘突，所述棘突具有包括凹陷凸轮面和突起凸轮面的后侧，并且其中多个不同尺寸的PS股骨部件的每一个都包括在其间限定髁间窝的一对分离的髁，以及定位在所述髁间窝中的后凸轮，所述后凸轮包括凹陷凸轮面和突起凸轮面，其中在第一阶段的屈曲过程中所述后凸轮的凹陷凸轮面接触所述棘突的突起凸轮面，并且在第二阶段的屈曲过程中，所述后凸轮的突起凸轮面接触所述棘突的凹陷凸轮面。
16.根据权利要求15所述的膝假体系统，其特征在于：每个不同尺寸的PS股骨部件的髁间窝都相对于股骨尺寸按比例地确定尺寸和成形，以便配合患者腿骨的特定解剖尺寸和形状。
17.根据权利要求12或权利要求13所述的膝假体系统，其特征在于：多个CR固定插入件的每一个都具有与所述多个CR固定插入件的其他的插入件不同的厚度，多个CR活动插入件的每一个都具有与所述多个CR活动插入件的其他的插入件不同的厚度，多个PS固定插入件的每一个都具有与所述多个PS固定插入件的其他的插入件不同的厚度，而多个PS活动插入件的每一个都具有与所述多个PS活动插入件的其他的插入件不同的厚度。
18.根据权利要求12或权利要求13所述的膝假体系统，其特征在于：还包括多个髌骨部件，任一个髌骨部件都能够与多个不同尺寸的CR股骨部件的任一个一起使用，并与多个不同尺寸的PS股骨部件的任一个一起使用。
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