CN1204953A - 人造关节,尤其是人造髋关节 - Google Patents

人造关节,尤其是人造髋关节 Download PDF

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Publication number
CN1204953A
CN1204953A CN97191419A CN97191419A CN1204953A CN 1204953 A CN1204953 A CN 1204953A CN 97191419 A CN97191419 A CN 97191419A CN 97191419 A CN97191419 A CN 97191419A CN 1204953 A CN1204953 A CN 1204953A
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China
Prior art keywords
supporting shell
bearing
fulcrum ball
rotation axis
workpiece
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Granted
Application number
CN97191419A
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English (en)
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CN1204855C (zh
Inventor
M·瑟利施
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Zimmer Inc
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Zimmer GmbH
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    • B24B11/00Machines or devices designed for grinding spherical surfaces or parts of spherical surfaces on work; Accessories therefor
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    • A61F2310/00389The prosthesis being coated or covered with a particular material
    • A61F2310/00395Coating or prosthesis-covering structure made of metals or of alloys

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Abstract

本发明介绍了一种人造髋关节的几何结构,它使得同类、耐磨的金属材料、例如,PROTASUL21WF能够在一个球形支承内用作支承壳(1)和支承球(2),能够不出现微件焊接以及过度磨损,同时,其它性能,如韧性、形状稳定性以及弹性,能够被应用在关节的功能中。通过支承面A和B的平均半径Rm、rm,以及允许形状偏差(12、13)和支承面允许粗糙度之间合适的关系,同类金属材料的微件焊接受到很大程度的阻碍。

Description

人造关节,尤其是人造髋关节
本发明涉及一种人造关节,尤其是一种人造髋关节,它有一个支承壳,和一个支承球,支承壳拥有中心为Ms的凹面球形支承面A,支承球拥有中心为Mk的凸面球形支承面B,支承面B通常相对于紧固轴D旋转对称地设置,紧固轴D位于人造髋关节杆的轴颈方向。
人造髋关节要求相对移动的支承体的材料配对,这种材料配对具有良好的自润滑性能。因此在材料组合方面的传统匹配方案,也包括不同种配件的配对。这样,相对软的聚乙烯制支承壳与硬质的金属或陶瓷关节体组合到一起,并且在人造髋关节刚起步时,具有不同硬度和耐磨性的金属材料互相组合。尽管作了一切努力,采用这些材料组合从来没能消除配件的磨损。对于聚乙烯材料来说,比如在髋关节内发生磨损,支承面每年被这种磨损朝主要作用力的方向磨去约0.2mm,而且,同样对于金属表面来说,由于集中荷载与微件焊接而在上表面内发生磨损现象,这种现象一旦开始,很快地使整个相互作用面受到损坏。
本发明的目的在于实现一种低磨损配置。这种配置具有独立的权利要求1中的特征,通过下述方式实现:即支承壳与关节头由一种耐磨金属材料制得;表面A具有平均半径Rm而表面B具有平均半径rm,二者间的差值为35μm<Rm-rm<85μm;表面A在角α处于90°<α<180°范围内的形状偏差小于±7.5μm;表面B在角β>140°范围内的形状偏差小于±2μm;支承球在面B之外,被回缩的表面C所延续,表面C具有比表面B到中心Mk更短的距离,而表面A的粗糙度相当于值Ra<0.08μm,并且表面B的粗糙度相当于值Ra<0.08μm。通过用同类,耐磨的金属材料生产、测量与搭配支承面,就在支承面之间实现了一种几何结构,这种几何结构与体液的毛细作用、以及支承面互相滑过时产生的浮力一起,很大程度地阻止了微焊接与磨损。通过抑制微焊接,对于同类、耐磨的金属材料来说,这些材料的有益的性能,例如韧性、形状稳定性与弹性能够得到利用。在均匀组织上产生的表面,既不会由于表面与基体之间的硬度差异受大荷载作用时被折断,又不会从基体上剥落。同时表面之间很好地互相适应,这样在静止状态下不会出现不允许的挤压。
如果表面A和B的粗糙度相当于Ra<0.05μm,这种效果还将更好。
如果钴铬镍材料,例如SULZER股份公司符合ISO5832/4的材料PROTASUL 21WF按下述工艺加工,它们都特别合适,在这种工艺情况下,球体的圆形生成面同样地转动,然而其转轴轴相对于工件的转轴线偏转,目的是磨削、精磨、抛光一个球形,直到达到前面提到的直径,形状精度与表面质量公差。
从属权利要求2至5和12提供了本发明合适的其它构造。通过使用比较高弹性的聚乙烯制内壳实现,内壳的可拆卸连接已为人所熟知。这不能由显著地更具有韧性的金属材料制内壳代替。功能与制造都与这种代替相矛盾。因此,有必要使支承壳在支承壳的外侧面与弹性塑料制、例如聚乙烯制中间体紧固连接,聚乙烯在它的另一侧面与外壳可拆卸地连接。如果中间体的可拆卸连接不变,尤其植入的塑料壳可被金属支承壳替换;如果支承球通过某种可拆卸连接。例如通过某种可拆卸的圆锥形连接设置在关节杆上,那么从精密度出发,必要的支承球同样能够被更换到假肢关节杆上。通过把支承球与支承壳设计为可更换方式,它以能够被无菌包装,一直到被送到手术台上。移植关节的位置控制还与操纵式支承球一起进行,操纵式支承球不会伤害支承壳,而精密支承球只有在接近结束时才被装入。
很有趣地发现,对于低磨损的金属/金属搭配来说,当处于前面的粗糙度Ra时,单个部件的形状误差对润滑起到比带宽更大的影响,平均半径差Rm-rm可以仅位于带宽内。对于人造髋关节通常的支承球直径,例如28mm的名义直径来说,允许平均半径差可为35μm<Rm-rm<85μm,如果从绝对力求达到的加工尺寸出发,而不是从选择配对出发,上述平均半径差相当于50μm的带宽。如果平分这个偏差带,对于两个部件来说,将为平均半径Rm或rm保留25μm的绝对生产精度。对放弃选择配对即把每个支承球与每种支承壳配对而言,该精度值已足够好。当然这只有当形状精度受到控制时才成为可能为了遵守必要的公差值。这种形状偏差必须被很精确地遵守,并且需要特殊的制造工艺。按照独立的权利要求6,通过下述方法实现上述直径、开头精度与粗糙度偏差值,即支承壳作为工件并作为一个按公差下限在支承面A的范围尺寸不足的内粗车削的壳并紧固,它的极轴位于在机床主轴的旋转内;或者粗车削的在支承面B内尺寸过大的支承球,具紧固轴D位于机床主轴的旋转轴线上;并且,在工件旋转期间,圆柱形磨削刀具的圆柱轴被旋转固定在刀具主轴的旋转轴内,圆柱形磨削刀具端面的圆形棱边在添加磨料的情况下压紧工件的支承面A,B,在这种情况下,刀具主轴的旋转轴在小于90°的偏转角度γ、δ内,δ工件主轴的旋转轴在某交叉点相交,并且在这种情况下,通过朝刀具主轴的旋转轴方向递送机床至轴,实现挤压力。
这种配置的优点在于,在工件与刀具各自所固定主轴上的刚性范围内,并在加工面上被互相对心。由于加工过程的运动,在工件与机床刀具上产生磨削,这种磨削强制性地导致在两种部件上形成球面。在刀具的端面切断边核上存在一条球面的窄圆形带,而在工件上产生相同的球形球面A、B。通过刀具加工面上的每个点面对工件加工面上的每个点进行磨削作用,产生完美球面片断A、B。
从属权利要求7至11介绍了该工艺其它合理的形式。下述内容对于制做支承壳的支承面A很合适。即把支承壳δ刀具旋转轴之间的角度在39°与45°之间进行选择。由于这样的话生成面以及与生成面相对应的圆柱的直径就可以被选择得很大,以至于界限角α可能增加到接近180°,而这个圆柱体并没有刮到壳的内部边缘,那么就形成了尽可能更大的支承面界限角。所以为了达到更大的界限角α。只有沿刀具旋转轴方向1的进刀运动是必要的。如果界限角α明显地小于180°,虽然可以选择更大的生成面圆直径,而生成面相反仅作为被断开的圆而啮合。
当制做支承球时已表明,只要一方面支承球除支承面以外的所有其它表面部分进一步缩回,并且另一方面在标准荷载状况下,支承壳与支承面B的赤道被调整到接近于互相平行,在这种条件下,当开头精度为±2μm时,界限角β约为180°的支承面B实质上已足够满足关节的功能要求。为了制做支承面B,圆柱形带空心筒的旋转刀具的偏转角γ,可以被更大限度地例如在60°至20°之间调整。由于产生的环形面即使当界限角β大于180°时也不会接近到支承面B的中心,所以,为了足够准确地外算推算剩下的加工期间,可以在加工期间,例如通过一个带有镶钻卡规面的卡规,测出支承面B的支承球直径。
除了在支承壳的支承面A的赤道上抛光入口半径外,为了支承壳与支承球必要的精度,还可以在数控机床上自动实施其余加工过程。
支承球与支承壳上的微小磨损比外展现了下述优点,即使用按照本发明的实施方法,没有必要由于支承面劣化,进行重新手术。由于这一原因,在用粘固的假肢杆时,支承球可以与杆连接为整体,而对于直接置入的杆、例如钛制杆来说,只要操作上没有出于空间原因规定支承球事后固定在转置的关节杆上,就使用一次性连接方法固定。由于仅有锚固的寿命决定了继续啮合的期限,使用在解剖学上相适应的,可牢固地锚定的关节杆是值得的,它具有S状杆形,杆形在近端的轴颈区域内有前倾部分,并且有一个靠后部沿曲线或弯曲段伸出的杆端头。
下面借助于实施例介绍本发明。图示为:
图1用简图方式展示了支承壳的一个纵向切面;
图2a用简图方式展示了界限角β<180°的支承球切面;
图2b用简图方式展示了界限角β<180°的支承球切面;
图3用简图与展开形式展示了支承壳与支承球的轮廓图,它以按其平均半径之间的差距来布置;
图4用简图形式展示了当在机床上加工时,支承球与刀具的位置;
图5用简图形式展示了当在机床上加工时,支承壳与刀具的位置;以及
图6用简图形式展示了支承壳的实施方式,支承壳与一个塑料中间体固定连接,塑料中间体的另一侧被以可拆卸方式固定在外侧的壳内。
使用这些图介绍的人造关节几何结构,使得同类、耐磨金属材料为PROTASUL 21WF有可能被用作为球面支座内的支承壳与支承球,却不出现微件焊接与过度磨损,而其它性能,如韧性、开头稳定性与弹性能够发挥作用。通过在支承面A和B的平均半径Rm、rm以及支承面容许形状偏差12、13和容许粗糙度之间合适的关系,大幅度阻止了同类金属材料的微件焊接。
在图1中表现了人造髋关节的支承壳1,它的球形支承面在约小于180°的α角度范围内延伸,并且拥有一段到球面中心的距离R。与图1类似,在图2a和2b中表现了一个具有球形支承面B的支承球2,它延伸的角度β>140°,并且拥有一段到支承球中心Mk的距离r。
在图2a和2b中的两种支承球在支承面B的外侧借助于准球面C继续延伸,然而球面C到支承面B中心Mk的距离比支承面β的半径γ小。这段较短的距离例如通过下述方式产生,即关节头在磨削之前考虑到区域C内的以后的中心点Mk,就已被加工成扁平形状或设计为锥形。支承球通过可拆卸锥形连接6与假肢杆27连接,这里的锥体紧固轴D与旋转对称支承面B的旋转轴互相重叠,这样支承面B与锥形连接无关,总占据相同的位置。
在图3中,以展开形式画出球形面A和B各自检测截面。画出了从一条未在图中展示的共同基线出发,平均距离Rm处在角α范围内延伸的支承面A,以及平均距离rm处,在角β范围内延伸的支承面B。其中,为了在图中垂直于扫描方向上的放大率比扫描展开方向大几十次方倍。支承壳的支承面A至平均半径Rm的允许开头偏差处于±7.5μm的一个偏差带宽度范围内,而粗糙度Ra<0.05μm。支承球的支承面B至平均半径rm的允许形状偏差为±2μm,而粗糙度Ra<0.05μm。如果这种组合的平均半径差位于35μm<Rm<rm<85μm的极限范围内,并且有某种耐磨的金属合金作为支承壳1和支承球2的原材料,合金例如渗有块状碳化物作为辅助体,那么在存在体液情况下达到一承载能力,尽管使用同类金属合金,却大幅度排队了在髋关节承受正常尚载时的表面微型焊接与破坏。
图4中的构造涉及一种支承球2,它用一个内圆锥面固定在定位芯轴23上,这里的定位芯轴23附属于一根机床主轴24,并且它绕它的旋转轴15的转速例如为850μ/mm,一根被偏转了例如为30°角度的刀具至轴20绕它的旋转轴16的转速例如为2000μ/mm,这里的两根旋转轴15、16在交叉点25上相交,这个点构成了后来加工完的支承球2中心点。在刀具主轴20内同轴有一根圆形的空心圆柱18,被定位作为加工刀具用于磨削、珩磨或抛光,它的被断开的圆形内棱18I,构成一根内径为di的生成面。空心圆柱由通常用于磨削、没有结合颗粒的材料、例如金属氧化物或碳化物组成。通过添加未在图中表示的磨料,并且朝进刀与旋转轴16方向压紧空心圆柱体18的端面,生成面表面18I与承压面B互相磨削为完美的支承面B截面,在这种情况下,支承面B的半径r十分缓慢地减小,而生成面18I被扩大到一个呈圆形、球形拱状的条带。通过相应的材料选择,在这个条带上的磨损可以被保持得很小。这样形成的支承面B能够通过附属的界限角β确定,并且在尺寸方向取决于刀具的偏转角γ与生成面的直径di。与此相应,如在图2a、2b中所示,支承面B的界限角β大于或小于180°。当如图4所示界限角β>180°时,为了经过一段可外推的时间确定中断对半径γ的成品尺寸的磨削,半径γ的验收可以在磨削期间通过经两根旋转轴15、16的交叉点25进行直径测量得以确定。对于偏转角γ和内径di来说,20°≤γ≤60°和1.8γ>di>1.1γ可以规定为最优区间。
在如图5所示的构造中,支承壳1以下述方式用卡盘21夹紧在机床主轴22内,即支承壳1的极轴与主轴22的旋转轴14叠合,这时主轴22的转速ns例如为850u/min。刀具主轴19偏转了一个偏转角δ,并且工件主轴22的旋转轴14与刀具主轴19的旋转轴在交叉点25相交,交叉点25相当于后来支承面A的中心。在刀具主轴内,同轴紧固了一根作为磨削刀具、用没有结合颗粒的材料制做圆形实心圆柱体17,它以例如为2050μ/min的转速转动,并且以其端面的外棱构成圆形生成面17a。通过添加磨料、并且朝刀具的旋转轴16的方向调整生成面17a,支承面A与生成面17a强制地磨削为完美的球面片段。为了更好地掌握半径R的尺寸,棱边17被预先核准为球形。其优点在于,刀具的磨损仅造成微不足道的尺寸变化,并且对支承壳1规定半径R的保证得以简化。对于偏转角δ来说,得到最佳范围是39°<δ<45°。如果支承面的界限角α不应过于低于180°,而且例如只应该朝刀具旋转轴16的方向进行进刀,对于生成面的外径da与偏转角δ来说,得出一个优选应用区域: 1.6 R < da cos &delta; < 2.2 R
图3中的图示用于,阐明关于平均半径Rm,rm的尺寸差、以及关于支承壳形状偏差的允许偏差12和支承球形状偏差的允许偏差13、和关于支承面A、B粗糙度的原则上的关联。在实践中,支承球2的质量通过使用“Talyround”测量仪表进行圆度测量得以监测。而为了从测量点确定平均的球形,并且内插形状偏差,支承壳在测量机上、在不同平面的内侧被径向用测针接触。在支承面B区域内的支承球2的允许开头偏差为±2μm,而对于支承壳的支承面A来说允许±7.5μm的开头偏差。两个部件的粗糙度Ra位于0.08μm以下,最好在0.05μm以下。
这种几乎无磨损的结构的承载能力很充足,这样关节头与支承壳的半径,如在图6中所示,可以被设计为小于通常的聚乙烯支承壳。这意味着,由于金属支承壳1可以配置具有足够壁厚的聚乙烯中间体4,中间体的外部尺寸相应于原来的聚乙烯支承壳的外部尺寸,所以即使对于被移置具有可更换的聚乙烯壳的外壳4来说,支承壳与关节头的更换也是可能的。在这种情况下,通过联接部分7与支承壳1牢固连接的中间体3可以比原来的聚乙烯支承壳拥有更小的壁厚。其优点在于,被移置的可更换聚乙烯壳可以被一个带有聚乙烯中间体、相应的金属支承壳替换。图6中的外壳4拥有直到其外侧三分之二高度的齿9,齿9朝向赤道,而在外侧上面的三分之一高度内设置尖11,它对准平行于极轴10的方向。一种这样的外壳可以在一个以骨头预备的尺寸较小的凹陷处楔入。这样尖11可以嵌入到未在图中表示的骨头基体内,而方向朝下的齿可以在初始应力的作用下在骨头基体附近滑过,并且用齿尖阻碍在末端位置的往回滑动,目的是实现足够的初始锚定。

Claims (12)

1.人造关节,尤其是人造髋关节,它具有一个支承壳(1)和支承球(2),支承壳(1)拥有中心为Ms的凹面球形面A;支承球(2)拥有中心为Mk的凸面球形面B;人造关节在通常情况下,被相对于紧固轴D、旋转对称地布置在人造髋关节杆的轴颈方向内;其特征在于:支承壳(1)与关节头(2)由一种耐磨金属材料制成;表面A的平均半径为Rm而表面B的平均半径为rm,这里它们的差值为35μm<Ra-rm<8.5μm;在90°<α<180°角度范围内延伸的表面A的形状偏差小于±7.5μm;在β>140°的角度范围内延伸的表面B的形状偏差小于±2μm;支承球(2)在表面B的外侧通过回缩的表面C来延续。表面C具有比表面B到中心点Mk更小的距离,而表面A的粗糙度相当于值Ra<0.08μm,并且表面B的粗糙度相当于值Ra<0.08μm。
2.如权利要求1所述的人造关节,其特征在于,表面A的粗糙度值Ra<0.05μm,而表面B的粗糙度值Ra<0.05μm。
3.如权利要求1或2所述的人造关节,其特征在于,支承壳(1)在它的外侧通过连接部分(7)与中间体(3)牢固地连接,其中的中间体可以以可拆卸方式与外壳(4)相连接。
4.如权利要求3所述的人造关节,其特征在于,中间体材料比金属支承壳材料的弹性大十倍。
5.如权利要求1所述的人造关节,其特征在于,支承球可以通过一种可拆卸的圆锥面连接(6),在紧固轴D的方向上与关节杆连接起来,目的是获得一种与连接无关、效果相同的局部球面B。
6.用于制作如权利要求1或2所述人造关节、尤其是人造髋关节的工艺,其特征在于,支承壳(1)作为工件并作为一个在支承面A的区域内尺寸不足的粗车削过的壳被紧固,其极轴(10)位于机床主轴(22)的旋转轴线(14)内;或者作为工件、已在支承面B的区域内尺寸不足的已被粗车削的支承球(2)被紧固,利用其紧固轴D位于机床主轴的旋转轴线放置(15)内;并且在工件旋转期间,一根圆柱形的磨削体(17、18)转到地紧固,其圆柱体轴位于刀具主体轴(19、20)的旋转轴线(16)上,其端面上的圆形棱边(17a、18)、在添加磨料的情况下,压靠到工件(1、2)的支承面A、B上,在这种情况下,刀具主轴(19、20)的旋转轴线(16)在偏转角(γ、δ)小于90°的区域内,与工件主轴(14、15)的旋转轴线在一个交叉点相交,并且这时通过沿刀具主轴的旋转轴线(16)的方向送进刀具主轴(19、20),产生压靠力。
7.如权利要求6所述的工艺,其特征在于,处于刀具主轴(19)的旋转轴线(16)与支承壳主轴(22)的旋转轴线(14)之间的角度(δ),位于45°和39°之间;并且圆形棱边(17a)的外径da如下选择,即遵守 1 . 6 R < da cos &delta; < 2 . 2 R
8.如权利要求6所述的工艺,其特征在于,位于刀具主轴(20)的旋转轴线(16)与支承球主轴(24)的旋转轴线(15)之间的角度(γ),在20°和60°之间,并且圆形棱边(18I)的内径di满足条件18γ>di>1.1γ。
9.如权利要求6至8中的一条所述的工艺,其特征在于,工件分别作为支承壳(1)以转速ns、作为支承球(2)以转速nk旋转,而这时刀具(17、18)拥有接近两倍于工件的转速(nw),然而最好不要形成工件的转速整数倍。
10.如权利要求6至9中的一条所述的工艺,其特征在于,采用磨削,珩磨或抛光。
11.如权利要求8所述的工艺,其特征在于,为了根据存储的金属去除率值,利用一种控制装置,确定加工到规定直径的剩余时间,在进行加工支承球(2)期间,进行表面B的通过中点Mk直径测量。
12.如权利要求1至5所述的人造髋关节,其特征在于,为了实现尽可能长的锚固寿命,关节杆具有S状与解剖学相适应的杆形,它在近端的轴颈区域内带有前倾部分,并且带有一个靠后部沿曲线或弯曲段外伸的杆端。
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