CN101669844A - 具有可控髁曲率的后十字韧带保持型骨科膝盖假体 - Google Patents
具有可控髁曲率的后十字韧带保持型骨科膝盖假体 Download PDFInfo
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Abstract
本发明涉及具有可控髁曲率的后十字韧带保持型骨科膝盖假体。一种骨科膝盖假体包括胫骨支承件和构造成与胫骨支承件关节连接的股骨部件。股骨部件包括在矢状面内弯曲的髁表面。髁表面的曲率半径在早期屈曲和中期屈曲之间逐渐变小。此外,在一些实施例中,曲率半径可在中期屈曲过程中增加。
Description
相关美国专利申请的交叉参考
【0001】对2008年6月30日申请的、专利申请号为No.XX/XXX,XXX、由Joseph G.Wyss发明的、名称为“Posterior Stabilized Orthopaedic Prosthesis HavingControlled Condylar Curvature”的美国专利申请;2008年6月30日申请的、专利申请号为No.XX/XXX,XXX、由John L.Williams发明的、名称为“OrthopaedicFemoral Component Having Controlled Condylar Curvature”的美国专利申请;2008年6月30日申请的、专利申请号为No.XX/XXX,XXX、由Joseph G.Wyss发明的、名称“Posterior Stabilized Orthopaedic Prosthesis”的美国专利申请;和2008年6月30日申请的、专利申请号为No.XX/XXX,XXX、由Joseph G.Wyss发明的、名称为“Orthopaedic Knee Prosthesis Having Controlled Condylar Curvature”的美国临时专利申请进行交叉参考,上述申请中的每一个的整体在此引用作为参考。
技术领域
【0002】本发明总体上涉及骨科假体,尤其是用在膝盖置换手术中的骨科假体。
背景技术
【0003】关节成形术是一种公知的外科手术程序,其使用假体关节来替换患病的和/或受损的天然关节。典型的膝盖假体包括胫骨盘、股骨部件聚合物插件或在胫骨盘和股骨部件之间定位的支承件。根据患者关节受损的严重程度,可以使用灵活变动的骨科假体。例如,当期望限制膝盖假体的运动,诸如当呈现重要软组织损伤或缺失时,膝盖假体可以包括“固定的”胫骨支承件。备选地,当期望更大的运动自由度时,膝盖假体可以包括“活动的”胫骨支承件。另外,膝盖假体可以是设计成替换患者股骨的两个髁的股骨-胫骨界面的整个膝盖假体,或是设计成替换患者股骨的单个髁的股骨-胫骨界面的单间隔的(或单髁的)膝盖假体。
【0004】用于替换患者天然膝盖的骨科膝盖假体的类型也取决于患者的后十字韧带在外科手术中是得以保持还是被牺牲掉(即移除)。例如,如果患者的后十字韧带在外科手术中损伤、患病和/或以其他方式被移除,后稳定膝盖假体可以用于以更后的屈曲度来提供另外的支撑和/或控制。备选地,如果后十字韧带是完整无缺的,可以使用十字保持型膝盖假体。
【0005】通常将典型的骨科膝盖假体设计成复制患者关节的自然运动。当膝盖屈曲和伸展时,股骨和胫骨部件关节连接并经受相对前后运动和相对内外转动的组合。但是,患者的周围软组织在贯穿关节的运动范围内也影响骨科膝盖假体的运动学和稳定性。即,由骨科部件上的患者软组织施加于骨科部件上的力会导致骨科膝盖假体不想要的或非期望的运动。例如,当股骨部件相对于胫骨支承件运动经过屈曲范围时,骨科膝盖假体可能呈现出大量非自然(反常的)前向平移(即,股骨部件和胫骨支承件之间的接触点前向移动)。该反常的前向平移可能导致关节稳定性的缺失、加速磨损、反常的膝盖运动学,和/或使患者在一些活动中经历非稳定性的感觉。
发明内容
【0006】根据一方面,骨科膝盖假体可以包括股骨部件和胫骨支承件。在一些实施例中,股骨部件可以实施为后十字保持型股骨部件。股骨部件可以包括在矢状面中弯曲的髁表面。胫骨支承件可以包括构造成与股骨部件的髁表面关节连接的支承表面。在一些实施例中,股骨部件的髁表面可以在髁表面上的第一接触点处以第一屈曲度来接触支承表面,以及在髁表面上的第二接触点处以第二屈曲度来接触支承表面。第一屈曲度可以小于大约30度。例如,第一屈曲度可以在0度到10度的范围内。第二屈曲度可以在45度到90度的范围内。例如,第二屈曲度可以在60度到90度的范围内。在一个特定的实施例中,第一屈曲度为大约5度,第二屈曲度为大约65度。
【0007】股骨部件的矢状面中的髁表面可以包括在第一接触点处的第一曲率半径和在第二接触点处的第二曲率半径。在一些实施例中,第一曲率半径和第二曲率半径之比可在1.10至1.45范围内。例如,在一个特定的实施例中,第一曲率半径与第二曲率半径之比为大约1.35。
【0008】在一些实施例中,矢状面中的髁表面还可以在髁表面上的第三接触点处以第三屈曲度来接触支承表面。第三屈曲度可以大于第二屈曲度。例如,第三屈曲度可以在80度至110度范围内。在一个特定的实施例中,第三屈曲度为大约90度。
【0009】矢状面中的髁表面在第三接触点处可以包括第三曲率半径。第三曲率半径可以大于第二曲率半径至少0.5毫米。第一曲率半径和第三曲率半径之比在1.10至1.45范围内,并且可小于第一曲率半径和第二曲率半径之比。例如,在一个特定的实施例中,曲率半径为大约1.28。
【0010】另外,在一些实施例中,髁表面可以在髁表面上的第四接触点处以第四屈曲度来接触支承表面。第四屈曲度可以大于第三屈曲度。例如,第四屈曲度可以在90度至120度范围内。在一个特定的实施例中,第三屈曲度为大约105度。
【0011】矢状面中的髁表面在第四接触点处还可以包括第四曲率半径。第四曲率半径可小于第三曲率半径。第一曲率半径和第四曲率半径之比可以在1.10至1.45范围内。例如,在一个特定的实施例中,曲率半径为大约1.305。
【0012】此外,在一些实施例中,当股骨部件从第一屈曲度向第二屈曲度运动时,髁表面可以在第一接触点和第二接触点之间的多个接触点接触支承表面。多个接触点中的每个接触点可由从公共原点延伸到多个接触点的各个接触点的射线限定。每条射线可具有由下式定义的长度:rθ=(a+(b*θ)+(c*θ2)+(d*θ3)),其中rθ为在θ屈曲度时限定接触点的射线长度,a为20至50之间的系数值,b为选自-0.30<b<0.0,0.00<b<0.30和b=0的区间内的系数值。如果b处于-0.30<b<0.00区间,则c为在0.00至0.012间的系数值,而d为在-0.00015至0.00间的系数值。备选地,如果b处于0<b<0.30区间,则c为在-0.010至0.00之间的系数值,而d为在-0.00015至0.00间的系数值。还备选地,如果b等于0,则c为处于选自-0.0020<c<0.00和0.00<c<0.0025的区间内的系数值,且d为在-0.00015至0.00之间的系数值。在一些实施例中,第一曲率半径的原点和射线的公共原点之间的距离在0至10毫米范围内。
【0013】在一些实施例中,股骨部件的髁表面在矢状面中可以包括第一弯曲表面部分和第二弯曲表面部分。在第二接触点和第三接触点之间可限定第一弯曲表面部分。在第三接触点和第四接触点之间可限定第二弯曲表面部分。在这样的实施例中,第一弯曲表面部分可具有大体等于第三曲率半径的基本恒定的曲率半径。另外,第二弯曲表面部分可具有大体等于第四曲率半径的基本恒定的曲率半径。
【0014】根据另一方面,骨科膝盖假体可包括股骨部件和胫骨支承件。在一些实施例中,股骨部件可实施为后十字保持型股骨部件。股骨部件可包括在矢状面中弯曲的髁表面。胫骨支承件可包括构造为与股骨部件的髁表面关节连接的支承表面。在一些实施例中,股骨部件的髁表面可以在髁表面上的第一接触点处以第一屈曲度来接触支承表面,在髁表面上的第二接触点处以第二屈曲度来接触支承表面,当股骨部件从第一屈曲度向第二屈曲度运动时,髁表面可以在第一接触点和第二接触点之间的多个接触点接触支承表面。第一屈曲度可以小于大约30度。例如,第一屈曲度可在0度到10度的范围内。第二屈曲度可在45度到90度的范围内。例如,第二屈曲度可在60度到90度的范围内。在一个特定的实施例中,第一屈曲度为大约5度而第二屈曲度为大约65度。
【0015】多个接触点中的每一个接触点可由从公共原点延伸到多个接触点的各个接触点的射线限定。每条射线可具有由下式定义的长度:rθ=(a+(b*θ)+(c*θ2)+(d*θ3)),其中rθ为在θ屈曲度时限定接触点的射线长度,a为处于20至50间的系数值,以及b为选自-0.30<b<0.0,0.00<b<0.30和b=0的区间中的系数值。如果b处于-0.30<b<0.00区间,则c为在0.00到0.012间的系数值,而d为在-0.00015到0.00间的系数值。备选地,如果b处于0<b<0.30区间,则c为在-0.010到0.00间的系数值,而d为在-0.00015到0.00间的系数值。还备选地,如果b等于0,则c为处于选自-0.0020<c<0.00和0.00<c<0.0025的区间中的系数值,且d为在-0.00015到0.00间的系数值。在一些实施例中,第一曲率半径的原点和射线的公共原点之间的距离在0到10毫米范围内。
【0016】另外,在一些实施例中,髁表面可在髁表面上的第三接触点处以第三屈曲度来接触支承表面,并且可在髁表面上的第四接触点处以第四屈曲度来接触支承表面。第三屈曲度可大于第二屈曲度,而第四屈曲度可大于第三屈曲度。矢状面中的髁表面可包括第一接触点处的第一曲率半径,第二接触点处的第二曲率半径,第三接触点处的第三曲率半径,以及第四接触点处的第四曲率半径。第一曲率半径与第三曲率半径之比可小于第一曲率半径与第二曲率半径之比。另外,第一曲率半径与第三曲率半径之比可小于第一曲率半径与第四曲率半径之比。例如,在一个特定的实施例中,第一曲率半径与第二曲率半径之比约为1.35,第一曲率半径与第三曲率半径之比约为1.28,第一曲率半径与第三曲率半径之比约为1.305。
【0017】此外,在一些实施例中,股骨部件的髁表面在矢状面中可包括第一弯曲表面部分和第二弯曲表面部分。在第二接触点和第三接触点之间可定义第一弯曲表面部分。在第三接触点和第四接触点之间可定义第二弯曲表面部分。在这样的实施例中,第一弯曲表面部分可具有大体等于第三曲率半径的基本恒定的曲率半径。另外,第二弯曲表面部分可具有大体等于第四曲率半径的基本恒定的曲率半径。
【0018】根据另一方面,骨科膝盖假体可包括股骨部件和胫骨支承件。股骨部件可包括在矢状面中弯曲的髁表面。胫骨支承件可包括构造成与股骨部件的髁表面关节连接的支承表面。在一些实施例中,股骨部件的髁表面可在髁表面上的第一接触点处以第一屈曲度来接触支承表面,在髁表面上的第二接触点处以第二屈曲度来接触支承表面,在髁表面上的第三接触点处以第三屈曲度来接触支承表面,以及当股骨部件从第一屈曲度向第二屈曲度运动时,髁表面可在第一接触点和第二接触点之间的多个接触点来接触支承表面。第一屈曲度可小于约30度,第二屈曲度可在45度到90度之间,且第三屈曲度可大于第二屈曲度。
【0019】股骨部件的矢状面中的髁表面可包括第一接触点处的第一曲率半径,第二接触点处的第二曲率半径,以及第三接触点处的第三曲率半径。第一曲率半径与第二曲率半径之比可在1.10到1.45范围内。第一曲率半径与第三曲率半径之比可小于第一曲率半径与第二曲率半径之比,并且可在1.10到1.45范围内。
【0020】多个接触点中的每一个接触点可由从公共原点延伸到多个接触点的各个接触点的射线限定。每条射线可具有由下式定义的长度:rθ=(a+(b*θ)+(c*θ2)+(d*θ3)),其中rθ为在θ屈曲度时限定接触点的射线长度,a为处于20至50之间的系数值,b为处于选自-0.30<b<0.0,0.00<b<0.30和b=0的区间的系数值。如果b处于-0.30<b<0.00区间,则c为在0.00到0.012间的系数值,而d为在-0.00015到0.00间的系数值。备选地,如果b处于0<b<0.30区间,则c为在-0.010到0.00间的系数值,而d为在-0.00015到0.00间的系数值。还备选地,如果b等于0,则c为处于选自-0.0020<c<0.00和0.00<c<0.0025的区间的系数值,且d为在-0.00015到0.00间的系数值。在一些实施例中,第一曲率半径的原点和射线的公共原点之间的距离在0到10毫米范围内。
【0021】另外,在一些实施例中,彼此间隔的每对髁可包括髁表面。在这样的实施例中,髁表面可以为大致对称的或者不对称的。
附图说明
【0022】详细描述具体参考以下附图,其中:
【0023】图1是骨科膝盖假体的一个实施例的分解透视图;
【0024】图2是大体沿着剖面线2-2截取的图1的骨科假体的股骨部件的一个实施例的横截面视图;
【0025】图3是以约0屈曲度放置于图1的骨科假体的胫骨支承件上的图2的股骨部件的横截面视图;
【0026】图4是以约45屈曲度放置的图3的股骨部件和胫骨支承件的横截面视图;
【0027】图5是以约90屈曲度放置的图3的股骨部件和胫骨支承件的横截面视图;
【0028】图6是一个仿真股骨部件的前后向平移的图表,所述仿真股骨部件具有位于各种屈曲度处的增加的曲率半径;
【0029】图7是另一个仿真股骨部件的前后向平移的图表,所述仿真股骨部件具有位于各种屈曲度处的增加的曲率半径;
【0030】图8是另一个仿真股骨部件的前后向平移的图表,所述仿真股骨部件具有位于各种屈曲度处的增加的曲率半径;
【0031】图9是另一个仿真股骨部件的前后向平移的图表,所述仿真股骨部件具有位于各种屈曲度处的增加的曲率半径;
【0032】图10是股骨部件尺寸族的曲率半径长度值和比值的一个实施例的表格;
【0033】图11是图1的骨科假体的股骨部件的一个实施例的横截面视图;
【0034】图12是股骨部件尺寸族的限定图1的股骨部件弯曲的多项式的系数值的一个实施例的表格;以及
【0035】图13是图1的股骨部件的另一个实施例的另一个髁的横截面视图。
具体实施方式
【0036】虽然本公开的构思易于具有各种修改和替代方式,其通过附图中的例子已经示出了其特定的示范性实施例,并将在此进行详细的描述。然而应该理解的是,并没有意图将本公开的构思限制于所公开的特殊形式,而相反,其意图在于覆盖所有落入由所附权利要求限定的本发明的精神和范围内的修改、等同变化以及可替代形式。
【0037】参考在此描述的骨科植入物和患者自然骨骼,在整个本公开中可以使用诸如前、后、内侧、外侧、上、下等等表示解剖学参考的术语。这样的术语在骨骼研究和骨科领域均具有众所周知的意义。在说明书和权利要求中这样的解剖学参考术语的使用意图在于与它们众所周知的意义保持一致,除非另外注明。
【0038】现在参考图1,在一个实施例中,后十字保持型骨科膝盖假体10包括股骨部件12、胫骨支承件14和胫骨盘16。示意性地,股骨部件12和胫骨盘16由诸如钴-铬或钛的金属材料构成,但在其它实施例中,也可以由诸如陶瓷材料、聚合物材料、生物工程材料等的其它材料形成。示意性地,胫骨支承件14由诸如超高分子量聚乙烯(UHMWPE)的聚合物材料形成,但在其它实施例中也可以由诸如陶瓷材料、金属材料、生物工程材料等的其它材料形成。
【0039】如下面进行更详细的讨论,将股骨部件12构造成与胫骨支承件14关节连接,所述胫骨支承件14被构造成与胫骨盘16连接。将胫骨支承件14实施为旋转或活动胫骨支承件并将所述胫骨支承件14构造成在使用中相对胫骨盘12旋转。但是,在其它实施例中,可以将胫骨支承件14实施为固定的胫骨支承件,其可以受到限制或约束以防相对胫骨盘16旋转。
【0040】将胫骨盘16构造成固定至外科手术准备的患者胫骨近端(未示出)。可以将胫骨盘16通过使用骨粘结或其它连接方式而固定至患者胫骨上。胫骨盘16包括具有顶表面20和底表面22的平台18。示意性地,顶表面20是大致平坦的,在一些实施例中可以是高抛光的。胫骨盘16也可以包括从平台18的底表面22向下延伸的杆24。腔或孔26限定在平台18的顶表面20中且向下延伸至杆24中。如下面更详细的讨论,孔26成形为容纳胫骨插件14的互补杆。
【0041】如上所讨论的,将胫骨支承件14构造成与胫骨盘16连接。胫骨支承件14包括具有上支承表面32和底表面34的平台30。在将胫骨支承件14实施为旋转或活动胫骨支承件的示意性实施例中,支承件14包括从平台30的底表面32向下延伸的杆36。当将胫骨支承件14连接至胫骨盘16时,杆36就容纳在胫骨盘16的孔26中。在使用中,将胫骨支承件14构造成绕着由杆36限定的轴线相对于胫骨盘16旋转。在将胫骨支承件14实施为固定的胫骨支承件的实施例中,支承件14可以或可以不包括杆22和/或可以包括其它装置或特征以将胫骨支承件14固定至非旋转构造的胫骨盘12上。
【0042】胫骨支承件14的上支承表面32包括内侧支承表面42和外侧支承表面44。将内侧和外侧支承表面42、44构造成容纳或以其它方式接触对应的股骨部件14的内侧和外侧髁,如下面更详细讨论。这样,每个支承表面42、44具有凹的轮廓。
【0043】将股骨部件12构造成连接患者股骨远端的外科手术准备表面(未示出)。可以将股骨部件12通过骨粘结或其它连接方式而固定至患者股骨上。股骨部件12包括具有一对内侧和外侧髁52、54的外关节连接表面50。将髁52、54间隔开以将髁内开口56限定在其间。在使用中,髁52、54替换患者股骨的天然髁且被构造成关节连接在胫骨支承件14的平台30的对应支承表面42、44上。
【0044】应认识到的是,将示意性的骨科膝盖假体10构造成替换患者的右膝盖,并且这样的,将支承表面42和髁52看作内侧定位;以及将支承表面44和髁54看作外侧定位。但是,在其它实施例中,可以将骨科膝盖假体10构造成替换患者的左膝盖。在这样的实施例中,应认识到的是支承表面42和髁52可以外侧定位而支承表面44和髁54可以内侧定位。无论如何,可以将在此描述的特征和构思并入构造成替换患者任一膝盖的骨科膝盖假体中。
【0045】现在参照附图2,股骨部件12的每个髁52、54包括髁表面100,其在矢状面中凸形地弯曲。髁表面100由多个弯曲表面部分102、104、106和108形成,其每个都与相邻的弯曲表面部分相切。每个弯曲表面部分102、104、106和108以不同屈曲度范围接触胫骨支承件14。例如,在早期屈曲期间,髁表面100的弯曲表面部分102、104接触胫骨支承件14。即,当股骨部件12以早期屈曲度相对于胫骨支承件14关节连接时,股骨部件12以每个早期屈曲度在弯曲表面部分102或弯曲表面部分104上的一个或多个接触点接触胫骨支承件14。例如,如图3所示,当股骨部件12以约0屈曲度定位时,股骨部件12在髁表面100上的接触点112接触胫骨支承件14的支承表面42。
【0046】类似地,髁表面100的弯曲表面部分104在中期屈曲中接触胫骨支承件14;并且髁表面100的弯曲表面部分106在后期屈曲中接触胫骨支承件14。当股骨部件12以中间屈曲度相对于胫骨支承件14关节连接时,股骨部件12以每个中期屈曲度在弯曲表面部分104上的一个或多个接触点接触胫骨支承件14。例如,如图4所示,当股骨部件12以约45屈曲度定位时,股骨部件12在髁表面100上的接触点114接触胫骨支承件14的支承表面42。另外,当股骨部件12以后期屈曲度相对于胫骨支承件14关节连接时,股骨部件12以每个后期屈曲度在弯曲表面部分106的一个或多个接触点接触胫骨支承件14。例如,如图5所示,当股骨部件12以约90屈曲度定位时,股骨部件12在髁表面100上的接触点116处接触胫骨支承件14的支承表面42。当然,应认识到的是,股骨部件12以任意一个特定的屈曲度在髁表面100上的多个接触点处接触胫骨支承件14。然而,为了清楚地描述,仅在图3-5中分别示出了接触点112、114、116。
【0047】返回参照附图2,髁表面100的每个弯曲表面部分102、106、108分别由恒定的曲率半径R1、R3、R4限定。然而,如下面更详细描述的,弯曲表面部分104由多条射线而非恒定的曲率半径限定。如下面更详细讨论的,弯曲表面部分104设计为将髁表面100从弯曲表面部分102的曲率半径R1逐渐过渡到曲率半径R2,弯曲表面部分104与弯曲表面部分106相切。
【0048】弯曲表面部分102、104、106、108被设计为使得股骨部件12相对胫骨支承件14的反常前向平移量减少或以其他方式延迟到更大的屈曲度发生。应认识到的是,通过将股骨部件开始任何反常前向平移延迟到更大的屈曲度,在患者的通常不能深度弯曲的活动中可以减少反常前向平移的总体发生率。
【0049】在典型的骨科膝盖假体中,无论何时膝盖假体以大于零度的屈曲度定位时,都可能发生反常前向平移。当骨科膝盖假体关节连接至较大屈曲度时,前向平移的可能性增加。在这样的方位中,只要股骨部件和胫骨支承件之间的切向(牵引)力不能满足下面等式时,股骨部件在胫骨支承件上的反常前向平移就可发生:
【0050】T<μN (1)
【0051】其中“T”为切向(牵引)力,“μ”为股骨部件和胫骨支承件的摩擦系数,“N”为股骨部件和胫骨支承件之间的法向力。通常而言,股骨部件和胫骨支承件之间的切向(牵引)力可以由下式限定:
【0052】T=M/R (2)
【0053】其中“T”为股骨部件和胫骨支承件之间的切向(牵引)力,“M”为膝盖力矩,“R”为在特定屈曲度与胫骨支承件接触的髁表面的矢状面中的曲率半径。应认识到的是,等式(2)是主导的现实中的等式的简化形式,其没有考虑如惯性和加速度的其它因素。无论如何,等式(2)提供骨科膝盖假体的反常前向平移可以通过控制股骨部件的髁表面的曲率半径而减少或延迟的见解。即,通过控制髁表面的曲率半径(如增加或维持曲率半径),等式(2)的右边减少,从而降低切向(牵引)力的值并满足等式(1)。如上所讨论的,通过确保切向(牵引)力满足等式(1),股骨部件在胫骨支承件上的反常前向平移可以减少或以其他方式延迟至更大的屈曲度。
【0054】基于上述分析,一种减少或者延迟股骨部件12的反常前向平移的方法是确保髁表面100在早期和中期屈曲范围中的曲率半径的变化不是太大或者太突然(如,曲率半径中的角度变化相对于屈曲度变化之比不是很大)。即,如果曲率半径R1与曲率半径R2、R3或R4之比过大,则可能发生股骨部件12的反常前向平移。这样,通过设计股骨部件12的髁表面100使得早期屈曲的弯曲表面部分102的曲率半径R1与(i)早期屈曲的弯曲表面部分104的曲率半径R2之比,与(ii)中期屈曲的弯曲表面部分106的曲率半径R3之比,以及与(iii)后期屈曲的弯曲表面部分108的曲率半径R4之比小于预定的阈值,能意想不到地减少或者以其他方式延迟反常前向滑动。
【0055】因此,在一个实施例中,股骨部件12的髁表面100被设计为这样,即曲率半径R1与曲率半径(i)R2、(ii)R3和(iii)R4之比的每一个都处于约1.10到约1.45之间。在一个特定的实施例中,髁表面100设计为这样,即曲率半径R1与曲率半径R2之比处于约1.30到约1.40之间,而在另一个特定的实施例中,约为1.35。此外,在一个特定的实施例中,髁表面100设计为这样,即曲率半径R1与曲率半径R3之比处于约1.20到约1.30之间,而在另一个特定的实施例中,约为1.28。再者,在一个特定的实施例中,髁表面100设计为这样,即曲率半径R1与曲率半径R4之比处于约1.25到约1.35之间,而在另一个特定的实施例中,约为1.305。
【0056】此外,根据关于等式(1)和(2)的上述分析,另一种减少或者延迟股骨部件12的反常前向平移的方法是在早期和/或中期屈曲过程中增加髁表面100的曲率半径。这样,在一个实施例中,股骨部件12的髁表面100设计为这样,即弯曲表面部分106的曲率半径R3大于弯曲表面部分104的曲率半径R2。
【0057】确定曲率半径R2和曲率半径R3之间的增加量,以及在产生这种增加时的髁表面100上的屈曲度,从而影响反常前向平移的产生。更详细的讨论见与此同时提交的序列号为XX/XXX,XXX,题目为“Orthopaedic FemoralComponent Having Controlled Condylar Curvature”的美国专利申请,其在此引用作为参考,采用LifeMOD/Knee Sim,2007.1.0 Beta 16软件程序执行对各种股骨部件设计的多个仿真以分析在早期屈曲度和中期屈曲度中增加股骨部件的髁表面的曲率半径的效果,所述软件程序可以从LifeModeler,Inc.of San Clemente,California商业获取。基于这样的分析,可以确定,可以通过在大约30屈曲度至大约90屈曲度范围内的屈曲度处增加髁表面的曲率半径大约0.5毫米至大约5毫米范围中的量来减少或以其他方式延迟股骨部件相对于胫骨支承件的反常前向平移。
【0058】例如,图6中示出的图表200呈现了使用股骨部件的深弯曲膝盖仿真的结果,其中髁表面的曲率半径在30屈曲度、50屈曲度、70屈曲度和90屈曲度处增加了0.5毫米(即从25.0毫米至25.5毫米)。类似地,图7中示出的图表300呈现了使用股骨部件的深弯曲膝盖仿真的结果,其中髁表面的曲率半径在30屈曲度、50屈曲度、70屈曲度和90屈曲度处增加了1.0毫米(即从25.0毫米至26.0毫米)。图8中示出的图表400呈现了使用股骨部件的深弯曲膝盖仿真的结果,其中髁表面的曲率半径在30屈曲度、50屈曲度、70屈曲度和90屈曲度处增加了2.0毫米(即从25.0毫米至27.0毫米)。再者,图9中示出的图表500呈现了使用股骨部件的深弯曲膝盖仿真的结果,其中髁表面的曲率半径在30屈曲度、50屈曲度、70屈曲度和90屈曲度处增加了5.0毫米(即从25.0毫米至26.0毫米)。
【0059】在图表200、300、400、500中,将股骨部件的内侧髁(“内侧”)和外侧髁(“外侧”)的髁最低或最远点(CLP)描绘成股骨部件相对胫骨支承件定位的图示。这样,向下倾斜的线表示股骨部件在胫骨支承件上的向后滚动,向上倾斜的线表示股骨部件在胫骨支承件上的前向平移。
【0060】如在图表200、300、400、500中所示出的,在每个实施例中股骨部件的前向滑动延迟直到大约100屈曲度之后;以及将前向平移量限制到小于大约1毫米。具体地,通过在更早屈曲度处髁表面的曲率半径更大量的增加来促进股骨部件在胫骨支承件上的“向后滚动”。当然,曲率半径的增加量和在引入这种增加时的屈曲度受到诸如患者膝盖的解剖学关节空隙、胫骨支承件的尺寸等的限制。无论如何,基于图表200、300、400、500中记录的仿真,股骨部件在胫骨支承件上的反常前向平移可以通过在早于中期屈曲过程中增加股骨部件的髁表面的曲率半径而减少或以其他方式延迟。
【0061】返回参照附图2,基于上述分析,在一个实施例中,股骨部件12的髁表面100设计为这样,即曲率半径R3大于曲率半径R2的量在约0.5毫米至约5毫米范围内。如下论述,在一些实施例中,特定的增加量可基于股骨部件的尺寸而定。此外,基于上述分析,髁表面100被设计为这样,即曲率半径从R2到R3的增加在约45到约90屈曲度范围内发生。在一个特定的实施例中,曲率半径从R2到R3的增加在髁表面100上的约65屈曲度时发生。
【0062】如上所述,弯曲表面部分104被设计为使曲率半径从R1逐渐过渡到曲率半径R2。这样,可基于所需的过渡率选择由弯曲表面部分104限定的角度大小。例如,在一个实施例中,股骨部件12的髁表面100设计为这样,即弯曲表面部分104从约0度到约30度范围内的第一屈曲度延伸到从约45度到约90度范围内的第二屈曲度。在一个特定的实施例中,弯曲表面部分104从约5屈曲度延伸到约65屈曲度。应认识到的是,弯曲表面部分104的定位(即,初始屈曲度)和大小(即,由此限定的角度)还至少部分地确定出早期屈曲的弯曲表面部分102的定位和大小。这样,在一个实施例中,弯曲表面部分102从约-10屈曲度(即,过度伸展10度)到约0屈曲度范围内的第一屈曲度延伸到从约5度到约30度范围内的第二屈曲度。在一个特定的实施例中,弯曲表面部分102从约-10屈曲度延伸到约5屈曲度。
【0063】类似地,弯曲表面部分106和108的定位和大小至少部分地确定了弯曲表面部分104的定位和大小。此外,弯曲表面部分106和108的定位和大小基于或者其他方式受限于膝盖的关节间隙的解剖学限制。也就是,股骨部件12的髁表面100的后侧的总体尺寸和构造被这样设计,即股骨部件12“装配”到膝盖的关节间隙中,且允许股骨部件12适当地固定到患者的手术准备远端股骨。如此,在一个实施例中,弯曲表面部分106从约45度到约90度范围内的第一屈曲度延伸到从约80度到约110度范围内的第二屈曲度。在一个特定的实施例中,弯曲表面部分106从约65屈曲度延伸到约90屈曲度。类似地,在一个实施例中,弯曲表面部分108从约80度到约110度范围内的第一屈曲度延伸到从约90度到约120度范围内的第二屈曲度。在一个特定的实施例中,弯曲表面部分106从约90屈曲度延伸到约105屈曲度。
【0064】应认识到的是,股骨部件12的髁表面100的曲率半径R2到R3的特定增加量和/或对髁表面100上的这种增加的定位还可基于股骨部件12的尺寸按比例调节或者受其他方式的影响。即,应认识到的是,髁表面100的曲率半径R2到R3的0.5毫米的增加在与较大尺寸股骨部件相比的小尺寸股骨部件中是相对较大的增加。如此,股骨部件12的髁表面100的曲率半径R2到R3增加的幅度可基于股骨部件的大小而改变。然而,在一个实施例中,曲率半径R1与曲率半径R2、R3和R4之比在股骨部件尺寸族中保持在基本恒定的值。
【0065】例如,如图10中所示,表格600为股骨部件尺寸族1到10限定了每个曲率半径R1、R2、R3、R4的长度。如在表格600中所示,股骨部件12的每个尺寸1-10的每个曲率半径R1、R2、R3、R4的长度可这样选择,即R1/R2、R1/R3、以及R1/R4之比在股骨部件尺寸上是基本恒定的。在示例性的实施例中,如之前讨论的,对于股骨部件尺寸1到10,曲率半径R1与曲率半径R2之比保持在大约1.35,对于股骨部件尺寸1到10,曲率半径R1与曲率半径R3之比保持在大约1.28,并且对于股骨部件尺寸1到10,曲率半径R1与曲率半径R4之比保持在大约1.305。
【0066】现在参照图11,基于对等式(1)和(2)的上述分析,另一种减少或者延迟股骨部件12在胫骨支承件14上的反常前向平移发生的方法是在离散的曲率半径之间逐渐过渡,这样在屈曲度范围内髁表面100的曲率半径的变化被减少。如此,在一个实施例中,早期屈曲的弯曲表面部分104设计为提供从第一曲率半径R1到第二曲率半径R2的逐渐过渡。为此,弯曲表面部分104由多条射线120定义,所述射线从公共原点O发出。多条射线120的每一条限定了弯曲表面部分104上的各个接触点130。虽然为了使得附图清晰,仅在图11中示出了三条射线120,但应认识到可采用无穷多条射线120来限定弯曲表面部分104。
【0067】基于每个屈曲度的每条射线120的长度可以确定每个接触点130的位置,接触点130共同限定了弯曲表面部分104。尤其地且令人意想不到地,已经确定通过根据下面的多项式限定弯曲表面部分104,能够减少或者延迟股骨部件12在胫骨支承件14上的反常前向平移,多项式为:
【0068】rθ=(a+(b*θ)+(c*θ2)+(d*θ3)), (3)
【0069】其中“rθ”为在“θ”屈曲度下限定弯曲表面部分104上的接触点130的射线120的长度(公制单位),“a”是20至50间的标量值,“b”是系数值,“b”如下选择:
【0070】-0.30<b<0.00, (4)
【0071】0.00<b<0.30,或者
【0072】b=0
【0073】如果选择的系数“b”在-0.30<b<0.00范围内,则系数“c”和“d”如下选择:
【0074】0.00<c<0.012,以及 (5)
【0075】-0.00015<d<0.00
【0076】备选地,如果选择的系数“b”在0.00<b<0.30范围内,则系数“c”和“d”如下选择:
【0077】-0.010<c<0.00,以及 (6)
【0078】-0.00015<d<0.00
【0079】再者,如果选择的系数“b”等于0,则系数“c”和“d”如下选择:
【0080】-0.0020<c<0.00,或者 (7)
【0081】0.00<c<0.0025,以及
【0082】-0.00015<d<0.00
【0083】应认识到的是,标量“a”和系数“b”、“c”和“d”的值的范围是多项式(3)的无穷多个可能解的子集。即,可从无穷多个可能解中确定上面提供的特定的范围组从而得出曲线族(即,弯曲表面部分104),其提供髁表面100从曲率半径R1到曲率半径R2的逐渐过渡,这样可减少或延迟股骨部件12相对于胫骨支承件14的前向平移。此外,应认识到的是,上面的每个系数“a”、“b”、“c”和“d”的数值范围是关于使用公制单位设计的实施例所提供的。然而,这种系数值的范围可转换到使用其他单位制的实施例中,例如英制单位。
【0084】弯曲表面部分104的总体形状还受到设置多条射线120的公共原点O的影响。通过限制多条射线120的公共原点O和曲率半径R1的原点122之间的距离124(其限定出早期屈曲的弯曲表面部分102),可以减少或者延迟股骨部件12在胫骨支承件14上的反常前向滑动。如此,在一个实施例中,多条射线120的公共原点O的位置这样选择,即公共原点O和曲率半径R1的原点120之间的距离124小于大约10毫米。
【0085】应认识到的是,在一些实施例中,公共原点O和曲率半径R1的原点122之间的距离124以及特定的系数值可基于股骨部件12的特定尺寸而定。例如,如图12所示,表格700示出了上面定义的多项式(3)的系数值以及公共原点O和曲率半径R1的原点122之间的距离124的值的一个特定实施例。如表格700所示,公共原点O和曲率半径R1的原点122之间的距离124和标量“a”的数值相对股骨部件尺寸而变化。然而,在这个特定的实施例中,系数“b”、“c”和“d”的数值相对股骨部件尺寸是恒定的。然而,应认识到的是,在其他的实施例中,系数值“b”、“c”和“d”可相对股骨部件的尺寸而变化。
【0086】上面已经关于股骨部件12的单一髁52、54对股骨部件12的髁表面100的总体形状和设计进行了描述。应认识到的是,在一些实施例中,股骨部件12的两个髁52、54可以是对称的且具有类似的髁表面100。但是,在其它实施例中,股骨部件12的髁52、54可以不对称。例如,如图13中所示,股骨部件12可包括具有髁表面800的第二髁52、54,髁表面800部分地由多个弯曲表面部分802、804、806、808限定。类似于髁表面100的弯曲表面部分102、104、106、108,每个弯曲表面部分802、804、806、808与每个邻接的髁表面800的弯曲表面部分相切。此外,弯曲表面部分802由曲率半径R5限定,曲率半径R5经由弯曲表面部分804逐渐过渡为曲率半径R6。类似于弯曲表面部分104,弯曲表面部分804由多条射线820限定,射线820从公共原点O1发出。此外,弯曲表面部分806由曲率半径R7限定,而弯曲表面部分808由曲率半径R8限定。
【0087】如此,在髁52、54对称的实施例中,弯曲表面部分202、802在基本相等的屈曲度之间延伸(即,弯曲表面部分202、802每个可从基本相等的早期屈曲度延伸到基本相等的后期屈曲度)。类似地,弯曲表面部分204、804在基本相等的屈曲度之间延伸,弯曲表面部分206、806在基本相等的屈曲度之间延伸,弯曲表面部分208、808在基本相等的屈曲度之间延伸。此外,曲率半径R5大致等于曲率半径R1,曲率半径R6大致等于曲率半径R2,曲率半径R7大致等于曲率半径R3,以及曲率半径R8大致等于曲率半径R4。再者,上述的等式(4)的系数值“a”、“b”、“c”和/或“d”的组对于两个髁是基本类似的。
【0088】然而,在其他实施例中,髁52、54是不对称的。如此,弯曲表面部分202、802可在不同的屈曲度之间延伸。此外,弯曲表面部分204、804可在不同的屈曲度之间延伸,弯曲表面部分206、806可在不同的屈曲度之间延伸,以及弯曲表面部分207、807可在不同的屈曲度之间延伸。
【0089】此外,在髁52、54非对称的那些实施例中,曲率半径R5可不同于曲率半径R1,曲率半径R6可不同于曲率半径R2,曲率半径R7可不同于曲率半径R3,和/或曲率半径R8可不同于曲率半径R4。再者,上述的等式(3)的系数值“a”、“b”、“c”和/或“d”的组在髁表面100和800之间可以是不同的。
【0090】虽然在附图和前面描述中已经对本公开进行了示出和描述,但是这样的示出和描述在本质上被认为是示例性的而非限制性的,要理解的是,只对示意性的实施例进行了示出和描述,在本公开精神内的所有改变和修改都需要得到保护。
【0091】本公开的多个优点来自本文描述的装置和组件的各种特征。要注意的是,本公开的装置和组件的可替代实施例可以不包括所有描述的特征,但仍从这类特征的至少一些优点中受益。那些本领域的普通技术人员可以容易地自行设计出结合本发明一个或多个特征并且落入由所附权利要求限定的本公开的精神和范围内的装置和组件。
Claims (10)
1、一种骨科膝盖假体,包括:
股骨部件,其具有在矢状面内弯曲的髁表面;以及
胫骨支承件,具有构造成与所述股骨部件的所述髁表面关节连接的支承表面,
其中,所述髁表面(i)在所述髁表面上的第一接触点处以第一屈曲度接触所述支承表面,所述第一屈曲度小于大约30度,以及(ii)在所述髁表面上的第二接触点处以第二屈曲度接触所述支承表面,所述第二屈曲度大于约45度,
其中(i)所述矢状面中的所述髁表面在所述第一接触点处具有第一曲率半径,(ii)所述矢状面中的所述髁表面在第二接触点处具有第二曲率半径,以及(iii)第一曲率半径与第二曲率半径之比在1.10到1.45的范围内。
2、根据权利要求1所述的骨科膝盖假体,其中所述第一曲率半径与所述第二曲率半径之比为大约1.35。
3、根据权利要求1所述的骨科膝盖假体,其中所述第一屈曲度在0度到10度的范围内,所述第二屈曲度在60度到70度的范围内。
4、根据权利要求1所述的骨科膝盖假体,其中:
(i)所述髁表面在所述髁表面上的第三接触点处以第三屈曲度接触所述支承表面,所述第三屈曲度大于所述第二屈曲度,以及
(ii)所述矢状面中的所述髁表面在所述第三接触点处具有第三曲率半径,所述第三曲率半径比所述第二曲率半径大至少0.5毫米。
5、根据权利要求4所述的骨科膝盖假体,其中所述第一曲率半径与所述第三曲率半径之比在1.10到1.45的范围内。
6、根据权利要求4所述的骨科膝盖假体,其中:
(i)所述髁表面在所述髁表面上的第四接触点处以第四屈曲度接触所述支承表面,所述第四屈曲度大于所述第三屈曲度,以及
(ii)所述矢状面中的所述髁表面在所述第四接触点处具有第四曲率半径,所述第四曲率半径小于所述第三曲率半径。
7、根据权利要求6所述的骨科膝盖假体,其中所述第一曲率半径与所述第二曲率半径之比为大约1.35,所述第一曲率半径与所述第三曲率半径之比为大约1.28,所述第一曲率半径与所述第三曲率半径之比为大约1.305。
8、根据权利要求6所述的骨科膝盖假体,其中:
所述股骨部件的所述髁表面在所述矢状面中包括(i)在所述第二接触点和所述第三接触点之间限定的第一弯曲表面部分,以及(ii)在所述第三接触点和所述第四接触点之间限定的第二弯曲表面部分,
所述第一弯曲表面部分具有大体等于所述第三曲率半径的基本恒定的曲率半径,以及
所述第二弯曲表面部分具有大体等于所述第四曲率半径的基本恒定的曲率半径。
9、根据权利要求1所述的骨科膝盖假体,其中:
所述第二屈曲度在45度到90度的范围内,
当所述股骨部件从所述第一屈曲度向所述第二屈曲度运动时,所述髁表面在所述第一接触点和所述第二接触点之间的多个接触点接触所述支承表面,以及
所述多个接触点中的每一个接触点由从公共原点延伸到所述多个接触点的各个接触点的射线所限定,每条射线具有由下列多项式定义的长度:
rθ=(a+(b*θ)+(c*θ2)+(d*θ3)),
其中rθ为在θ屈曲度时限定接触点的射线长度,a为处于20至50之间的系数值,b为处于选自-0.30<b<0.00、0.00<b<0.30和b=0的区间的系数值,
其中当b处于-0.30<b<0.00区间时,(i)c为在0.00到0.012间的系数值,(ii)d为在-0.00015到0.00之间的系数值,
其中当b处于0<b<0.30区间时,(i)c为在-0.010到0.00间的系数值,(ii)d为在-0.00015到0.00间的系数值,以及
其中当b等于0时,(i)c为处于选自-0.0020<c<0.00和0.00<c<0.0025的区间的系数值,(ii)d为在-0.00015到0.00间的系数值。
10、根据权利要求9所述的骨科膝盖假体,其中:
所述第一曲率半径具有原点,以及
在所述第一曲率半径的原点和所述射线的公共原点之间的距离在0到10毫米范围内。
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AU2016200458B2 (en) | 2017-05-25 |
AU2016200458A1 (en) | 2016-02-18 |
US20140243987A1 (en) | 2014-08-28 |
CN101669844B (zh) | 2014-03-26 |
US9452053B2 (en) | 2016-09-27 |
AU2009202632A1 (en) | 2010-01-14 |
JP2010012261A (ja) | 2010-01-21 |
EP2275054A1 (en) | 2011-01-19 |
EP2275053A1 (en) | 2011-01-19 |
JP5631561B2 (ja) | 2014-11-26 |
US20120239158A1 (en) | 2012-09-20 |
ES2570378T3 (es) | 2016-05-18 |
US20090326664A1 (en) | 2009-12-31 |
US8784496B2 (en) | 2014-07-22 |
ES2562676T3 (es) | 2016-03-07 |
EP2275054B1 (en) | 2016-02-10 |
ES2570453T3 (es) | 2016-05-18 |
EP2147660A1 (en) | 2010-01-27 |
JP6133239B2 (ja) | 2017-05-24 |
JP2014208265A (ja) | 2014-11-06 |
EP2275053B1 (en) | 2015-11-25 |
US8192498B2 (en) | 2012-06-05 |
EP2147660B1 (en) | 2016-02-24 |
AU2009202632B2 (en) | 2015-11-05 |
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