CN101642394B - 具有可控制髁曲的整形外科股骨部件 - Google Patents

具有可控制髁曲的整形外科股骨部件 Download PDF

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CN101642394B
CN101642394B CN200910163957.7A CN200910163957A CN101642394B CN 101642394 B CN101642394 B CN 101642394B CN 200910163957 A CN200910163957 A CN 200910163957A CN 101642394 B CN101642394 B CN 101642394B
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J·G·威斯
C·M·沃纳
D·索科洛夫
J·S·李
J·L·威廉斯
S·T·戈马
J·M·阿马科斯特
D·W·伦普尔
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DePuy Products Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • A61F2/3836Special connection between upper and lower leg, e.g. constrained
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • A61F2/3859Femoral components
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • A61F2/3868Joints for elbows or knees with sliding tibial bearing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/30199Three-dimensional shapes
    • A61F2002/30242Three-dimensional shapes spherical
    • A61F2002/30245Partial spheres

Abstract

本发明涉及具有可控制髁曲的整形外科股骨部件,其中外科整形膝关节假体包括具有髁表面的股骨部件。髁表面由一个或多个曲率半径限定,其被控制以减少或延迟股骨部件相对胫骨支承的前向平移的开始。

Description

具有可控制髁曲的整形外科股骨部件
相关美国专利申请的交叉参考
本申请根据35 U.S.C.§119(e)要求2008年6月30日申请的、专利申请号为No.61/077,124、由Joseph G.Wyss等人发明的、名称为“Orthopaedic FemoralComponent Having Controlled Condylar Curvature,”的美国临时专利申请的优先权,其整个引用在此作为参考。
对2008年6月30日申请的、专利申请号为No.12/165,579、由John L.Williams等人发明的、名称为“Orthopaedic Femoral Component Having ControlledCondylar Curvature”的美国实用专利;2008年6月30日申请的、专利申请号为No.12/165,574、由Christel M.Wagner发明的、名称为“Posterior Cruciate-RetainingOrthopaedic Knee Prosthesis Having Controlled Condylar Curvature”的美国实用专利;2008年6月30日申请的、专利申请号为No.12/165,575、由Joseph G.Wyss发明的、名称为“Posterior Stabilized Orthopaedic Knee Prosthesis Having ControlledCondylar Curvature”的美国实用专利;以及2008年6月30日申请的、专利申请号为No.12/165,582、由Joseph G.Wyss发明的、名称为“Posterior StabilizedOrthopaedic Prosthesis”的美国实用专利进行交叉参考;其每一个的整体在此引用作为参考。
技术领域
本公开通常涉及整形外科假体,尤其是用在膝关节替换外科手术中的整形外科假体。
背景技术
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。典型的膝关节假体包括胫骨盘、股骨部件和聚合物插件或在胫骨盘和股骨部件之间定位的支承。根据患者关节受损的严重程度,可以使用灵活变通的整形外科假体。例如,当期望限制膝关节假体的运动,诸如当呈现重要软组织缺失或损伤时,膝关节假体可以包括“固定的”胫骨支承。备选地,当期望更大的运动自由度时,膝关节可以包括“运动的”胫骨支承。另外,膝关节假体可以是设计成替换患者股骨的两个髁的股骨-胫骨界面的整个膝关节假体,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)膝关节假体。
用于替换患者天然膝关节的整形外科膝关节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(即被移除)。例如,如果患者的后十字韧带在外科手术中损伤、患病和/或另外被移除,后稳定膝关节假体可以用于以更后的屈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,可以使用十字保持膝关节假体。
通常将典型的整形外科膝关节假体设计成复制患者关节的自然运动。当屈膝和伸展膝关节时,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整形外科膝关节假体的运动学和稳定性。即,由患者软组织施加于整形外科部件上的力会导致整形外科膝关节假体不想要的或非期望的运动。例如,当股骨部件在通过屈膝范围内移动时,整形外科膝关节假体可以展示多个非自然(反常的)前向平移。
在典型的整形外科膝关节假体中,反常的前向平移可以在近似任何屈度处发生,但尤其是在后屈度的中间处发生。通常可以将反常的前向平移限定为胫骨支承上股骨部件反常的相对运动,其中股骨部件和胫骨支承之间的接触“点”关于胫骨支承前向“滑动”。该反常的前向平移可导致关节稳定性的缺失、加速破损、反常的膝关节运动学和/或使得患者在一些活动中经受非稳定性的感觉。
发明内容
根据一个方面,整形外科膝关节假体可以包括股骨部件和胫骨支承。股骨部件可以具有在矢状面中弯曲的髁表面。胫骨支承可以包括构造成与股骨部件的髁表面关节连接的支承面。股骨部件的髁表面可构造成髁表面上的第一接触点处以小于大约30度的第一屈度来接触支承面。股骨部件的髁表面还可以构造成在髁表面上的第二接触点处以大于大约45度的第二屈度来接触支承面。另外,股骨部件的髁表面可构造成在髁表面上的第三接触点处以大于第二屈度的第三屈度来接触支承面。在一些实施例中,第一屈度可以在0度至10度的范围内,第二屈度可以在60度至70度的范围内,以及第三屈度可以在80度至110度的范围内。例如,在一个特别的实施例中,第一屈度是大约5度,第二屈度是大约65度,以及第三屈度是大约90度。
矢状面中的髁表面在第一接触点处可以具有第一曲率半径,在第二接触点处具有第二曲率半径,以及在第三接触点处具有第三曲率半径。在一些实施例中,第三曲率半径可以大于第二曲率半径至少0.5毫米。另外,在第一接触点和第二接触点之间的矢状面中的髁表面可包括多个弯曲表面片段。每个弯曲表面片段可具有不同的曲率半径。
多个弯曲表面片段可包括最前弯曲表面片段。在一些实施例中,最前弯曲表面片段的曲率半径可具有大于多个弯曲表面片段中的其它任一弯曲表面片段曲率半径的长度。另外,在一些实施例中,每个在最前弯曲表面片段之后的弯曲表面片段的曲率半径的长度可小于在前邻近的弯曲表面片段的曲率半径的长度。例如,在一些实施例中,每个在最前弯曲表面片段之后的弯曲表面片段的曲率半径的长度小于在前邻近的弯曲表面片段的曲率半径的长度0.1毫米至5毫米范围内、1毫米至3毫米的范围内和/或大约1毫米的距离。
多个弯曲表面片段中的每一个可对应一个对应角。在一些实施例中,多个弯曲表面片段对应的每个角是大致相等的。在其它的实施例中,由每个在最前弯曲表面片段之后的弯曲表面片段对应的角可小于由在前邻近的弯曲表面片段对应的角。例如,在一些实施例中,由每个在最前弯曲表面片段之后的弯曲表面片段对应的角可小于由在前邻近的弯曲表面片段对应的角0.5度至5度范围内的量。另外,在其它实施例中,由每个在最前弯曲表面片段之后的弯曲表面片段对应的角可大于由在前邻近的弯曲表面片段对应的角。例如,在一些实施例中,由每个在最前弯曲表面片段之后的弯曲表面片段对应的角可大于由在前邻近的弯曲表面片段对应的角0.5度至5度范围内的量。
根据另一方面,整形外科膝关节假体可以包括股骨部件和胫骨支承。股骨部件可以具有在矢状面中弯曲的髁表面。胫骨支承可以是构造成与股骨部件的髁表面关节连接的支承面。股骨部件的髁表面可以构造成在髁表面上的第一接触点处以在0至大约30度范围内的第一屈度来接触支承面。股骨部件的髁表面也可以构造成在髁表面上的第二接触点处以在45度至90度范围内的第二屈度来接触支承面。在第一接触点和第二接触点之间的矢状面内的髁表面可包括至少五个弯曲表面片段。每个弯曲表面片段可具有与其他弯曲表面片段不同长度的曲率半径。
多个弯曲表面片段可包括最前弯曲表面片段。最前弯曲表面片段的曲率半径可具有大于多个弯曲表面片段中其它任一弯曲表面片段曲率半径的长度。另外,每个在最前弯曲表面片段之后的弯曲表面片段的曲率半径的长度可以小于在前邻近的弯曲表面片段的曲率半径的长度。例如,在最前弯曲表面片段之后的每个弯曲表面片段的曲率半径的长度可以小于在前邻近的弯曲表面片段的曲率半径的长度1毫米至3毫米范围内的距离。
多个弯曲表面片段的每一个可对应一个对应角。在一些实施例中,由每个在最前弯曲表面片段之后的弯曲表面片段对应的角可小于由在前邻近的弯曲表面片段对应的角。在其它实施例中,由每个在最前弯曲表面片段之后的弯曲表面片段对应的角可大于由在前邻近的弯曲表面片段对应的角。
根据另一方面,整形外科膝关节假体可以包括股骨部件和胫骨支承。股骨部件可以具有在矢状面中弯曲的髁表面。胫骨支承可以是构造成与股骨部件的髁表面关节连接的支承面。股骨部件的髁表面可以构造成在髁表面的第一接触点处以0至大约30度范围内的第一屈度与胫骨支承接触。股骨部件的髁表面也可以构造成在髁表面的第二接触点处以45度至90度范围内的第二屈度与胫骨支承接触。在第一接触点和第二接触点之间的矢状面内的髁表面可以包括至少五个弯曲表面片段,每个弯曲表面片段可对应一个相应的、基本上相等的角,并可以具有不同于其他弯曲表面片段的曲率半径。
附图说明
参照附图,进行详细描述,其中:
图1是整形外科膝关节假体的一个实施例的分解透视图;
图2是整形外科膝关节假体的另一个实施例的分解透视图;
图3是股骨部件和图1胫骨支承的一个实施例的横截面视图,所述图1的胫骨支承通常是沿着剖面线2-2所作的且具有关节连接至第一屈度的股骨部件;
图4是股骨部件和图3的胫骨支承的横截面视图,所述图3的胫骨支承具有关节连接至第二屈度的股骨部件;
图5是股骨部件和图3的胫骨支承的横截面视图,所述图3的胫骨支承具有关节连接至第三屈度的股骨部件;
图6是图1的股骨部件的另一个实施例的横截面视图;
图7是图1的股骨部件的另一个实施例的横截面视图;
图8是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屈度处的增加的曲率半径;
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屈度处的增加的曲率半径;
图10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屈度处的增加的曲率半径;
图11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屈度处的增加的曲率半径;
具体实施方式
虽然本公开的观念易受各种修改和替代形式的影响,其具体的例证性实施例已经通过图中实例的形式示出且在此将进行详细的描述。然而应该理解的是,并没有意图将本公开的观念限制于所公开的特殊形式,但相反,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。
参考在此描述的整形外科植入物和患者天然解剖结构二者,在贯穿该公开中可以使用诸如前、后、中间、横向、上、下及其它的表示解剖参考的术语。这样的术语在解剖学学习和整形外科领域均具有很好理解的意义。在说明书和权利要求中这样的解剖参考术语的使用意图在于与它们很好理解的意义保持一致,除非另外注明。
现在参照图1,在一个实施例中,整形外科膝关节假体10包括股骨部件12、胫骨支承14和胫骨盘16。示意性地,股骨部件12和胫骨盘16由诸如钴-铬或钛的金属材料形成,但在其它实施例中,也可以由诸如陶瓷材料、聚合材料、生物工程材料或相似的其它材料形成。示意性地,胫骨支承14由诸如超高分子量聚乙烯(UHMWPE)的聚合材料形成,但在其它实施例中也可以由诸如陶瓷材料、金属材料、生物工程材料或相似的其它材料形成。
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14关节连接,所述胫骨支承14被构造成连接胫骨盘16。在图1的示意性实施例中,将胫骨支承14具体化为旋转或移动支承以及将所述胫骨支承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14具体化为固定的胫骨支承,其可以受相对胫骨盘16的旋转的限制或约束。
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经由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磨光的。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。将腔或孔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的补充杆。
如上所讨论的,将胫骨支承14构造成连接胫骨盘16。胫骨支承14包括具有顶支承面32和底表面34的平台30。在示意性实施例中,其中将胫骨支承14具体化为旋转或移动胫骨支承,支承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14连接至胫骨盘16上时,杆36就容纳在胫骨盘16的孔26中。在使用中,将胫骨支承14构造成绕着由相对于胫骨盘16的杆36限定的轴旋转。在实施例中,其中将胫骨支承14具体化为固定的胫骨支承,支承14可以或可以不包括杆22和/或包括其它装置或特征以将胫骨支承14固定至非旋转构造的胫骨盘12上。
胫骨支承14的顶支承面32包括中间支承面42和横向支承面44。将中间和横向支承面42、44构造成容纳或另外接触如下面更详细讨论的对应的股骨部件14的中间和横向髁。同样地,每个支承面42、44具有凹轮廓。
将股骨部件12构造成连接患者股骨的远端外科手术准备表面(未示出)。可以将股骨部件12经由骨粘结或其它连接方式而固定至患者股骨上。股骨部件12包括具有一对中间和横向髁52、54的外关节连接表面50。将髁52、54间隔开以将内髁开口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14的平台30的对应支承面42、44上。
将图1的示意性整形外科膝关节假体10具体化为后十字-保持膝关节假体。即,将股骨部件12具体化为后十字-保持膝关节假体并将胫骨支承14具体化为后十字-保持胫骨支承14。但是,在其它实施例中,如图2所示意的,可以将整形外科膝关节假体10具体化为后十字-牺牲式膝关节假体。
在这样的实施例中,将胫骨支承14具体化为后稳定化胫骨支承且包括从平台30向上延伸的隆起60。将隆起60定位在支承面42、44之间且包括前侧62和具有凸轮表面66的后侧64。在示意性实施例中,凸轮表面66具有大致凹入弯曲。但是,包括具有其它几何结构的凸轮表面66的隆起60可以用在其它实施例中。例如,包括具有大致“S”形横截剖面隆起的胫骨支承可以用在其它实施例中,诸如在此被引用作为参考的申请号为12/165,582、由Joseph G.Wyss发明的、名称为“Posterior Stabilized Orthopaedic Knee Prosthesis”的美国专利中描述的胫骨支承。
另外,在这样的实施例中,将股骨部件12具体化为后稳定化股骨部件且包括内髁切口或凹槽57(而不是开口56)。将后凸轮80(在幻影中示出)和前凸轮82定位在内髁切口57中。后凸轮80朝向股骨部件12的后侧定位且包括构造成在使用中与胫骨支承12的隆起60的凸轮表面66接合或另外接触的凸轮表面86。
应该理解的是,即使将整形外科膝关节假体10具体化为后十字-保持或十字-牺牲式膝关节假体,下面对膝关节假体10的股骨部件12和胫骨支承14进行讨论且在剩下的附图中进行了示意,关于后十字-保持膝关节假体,理解的是这样的描述同样应用于如下这些实施例中,即在这些实施例中将整形外科膝关节假体10具体化为后十字-牺牲式(后稳定化)整形外科膝关节假体。
应该理解的是,将示意性的整形外科膝关节假体10构造成替换患者的右膝关节,以及同样的,将支承面42和髁52看作中间定位;以及将支承面44和髁54看作横向定位。但是,在其它实施例中,可以将整形外科膝关节假体10构造成替换患者的左膝关节。在这样的实施例中,应该理解的是支承面42和髁52可以横向定位而支承面44和髁54可以中间定位。无论如何,可以将在此描述的特征和概念并入构造成替换患者任一膝关节的整形外科膝关节假体中。
现在参照图3-5,将股骨部件12构造成在使用中关节连接在胫骨支承14上。股骨部件12的每个髁52,54包括髁表面100,其在矢状面中凸向弯曲且被构造成接触各自的支承面42、44。例如,在图3所示的一个实施例中,当整形外科膝关节假体10处在伸展中或另外不是处于屈膝(如大约0度屈膝)中,髁52的髁表面100在髁表面100的一个或多个接触点102处接触支承面42(或关于髁54的支承面44)。
另外,当整形外科膝关节假体10通过中间屈度进行关节连接时,股骨部件12在髁表面100的一个或多个接触点处接触胫骨支承14。例如,在如图4所示的一个实施例中,当以中间屈度(如大约45度)关节连接整形外科膝关节假体10时,髁表面100在髁表面100上的一个或多个接触点104处接触支承面42。类似地,当以后屈度(如大约70屈度)关节连接整形外科膝关节假体10时,如图5所示,髁表面100在髁表面100上的一个或多个接触点106处接触支承面42。应该理解的是,当然,股骨部件12可以在髁表面100上的多个接触点处以任一特殊屈度来接触胫骨支承14。但是,为了描述清晰,在图3-5中只分别示意了接触点102、104、106。
将整形外科膝关节假体10构造成相对胫骨支承14的股骨部件12的大量反常前向平移可以减少或另外延迟至更后的(即更大)屈度。尤其是,如下面更详细的讨论,一个或两个髁52、54的髁表面100具有特殊的几何结构或构造成减少和/或延迟前向平移的弯曲,以及在一些实施例中,促进股骨部件12的“向后滚动”或后向平移。应该理解的是,通过将股骨部件12的反常前向平移的开始延迟到更大的屈度,在患者的这些活动中可以减少反常前向平移的整个发生,其中典型地不会导致过度屈膝。
在典型的整形外科膝关节假体中,无论何时膝关节假体以大于零度的屈度定位时,都可以发生反常前向平移。当以大屈度尤其是在中屈度范围中关节连接整形外科膝关节假体时,前向平移的可能性通常是增加的。在这样的方位中,无论何时股骨部件和胫骨支承之间的切向(牵引)力不能满足下面方程式时,胫骨支承上股骨部件的反常前向平移可以发生:
T<μN    (1)
其中“T”是切向(牵引)力,“μ”是股骨部件和胫骨支承的摩擦系数,以及“N”是股骨部件和胫骨支承之间的法向力。通常而言,股骨部件和胫骨支承之间的切向(牵引)力可以由下式限定:
T=M/R    (2)
其中“T”是股骨部件和胫骨支承之间的切向(牵引)力,“M”是膝关节力矩,以及“R”是以特殊屈度与胫骨支承接触的髁表面的矢状面中的曲率半径。应该理解的是,方程式(2)是管理现实中方程式的简化形式,其没有考虑如惯量和加速度的其它因素。无论如何,方程式(2)提供整形外科膝关节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洞察。即,通过控制髁表面的曲率半径(如增加或维持曲率半径),方程式(2)的右边减少,从而降低切向(牵引)力的值并满足方程式(1)。如上所讨论的,通过确保切向(牵引)力满足方程式(1),胫骨支承上股骨部件的反常前向平移可以减少或另外延迟至更大的屈度。
基于以上分析,为了减少或延迟反常前向平移的开始,对股骨部件12的一个或两个髁52、54的髁表面100的几何结构进行控制。例如,在一些实施例中,对髁表面100的曲率半径进行控制,由此曲率半径在一个屈度范围内保持恒定和/或在早于中间屈度范围内增加。相比而言,典型股骨部件具有在远曲率半径处(即在大约0屈度处)开始降低的曲率半径。但是,已经确定,通过在早于中间屈度的整个预定范围内维持相对恒定的曲率半径(即不降低曲率半径)和/或在预定屈度范围内增加曲率半径,可以减少或延迟股骨部件12的反常前向平移。
另外,在一些实施例中,髁表面100构造成或设计成使得髁表面100离散曲率半径之间的变化是平缓的。即,通过离散曲率半径之间的渐变而不是骤变,可以减少或延迟股骨部件12的反常前向平移。另外,在一些实施例中,对在早于中间屈度范围(如从大约0度至大约90度)内的髁表面的曲率半径中的变化率进行控制,由此变化率小于预定阈值。即,可以确定,如果髁表面100的曲率半径的降低率大于预定阈值,则可以发生反常前向平移。
相应地,在如图6-12所示意的一些实施例中,股骨部件12的髁表面100在早于中间屈度中具有增大的曲率半径。通过增加曲率半径,反常前向平移可以减少或延迟至更后的屈度。确定曲率半径R2和曲率半径R3之间增加量(见图6和7)以及在该处产生这样增加的髁表面100上的屈度,以影响反常前向平移的产生。在申请号为No.12/165,579、名称为“Orthopaedic Femoral Prosthesis HavingControlled Condylar Curvature”的美国专利申请中进行了更详细的描述,其与本发明同时提出并引用在此作为参考,使用lifeMOD/Knee Sim,version 1007.1.0Beta 16软件程序执行各种股骨部件设计的多个仿真以分析增加在较早屈度和中间屈度中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进行商业获取。基于这样的分析,可以确定,相对胫骨支承的股骨部件的反常前向平移可以通过增加髁表面的曲率半径大约0.5毫米至大约5毫米范围中的量或大约30屈度至大约90屈度范围内的更大屈度来减少或另外延迟。
例如,在图8中示意的图表200呈现了使用股骨部件的深弯曲膝关节仿真的结果,其中髁表面的曲率半径在30屈度、50屈度、70屈度和90屈度处增加了0.5毫米(即从25.0毫米至25.5毫米)。类似地,在图9中示意的图表300呈现了使用股骨部件的深弯曲膝关节仿真的结果,其中髁表面的曲率半径在30屈度、50屈度、70屈度和90屈度处增加了1.0毫米(即从25.0毫米至26.0毫米)。在图10中示意的图表400呈现了使用股骨部件的深弯曲膝关节仿真的结果,其中髁表面的曲率半径在30屈度、50屈度、70屈度和90屈度处增加了2.0毫米(即从25.0毫米至27.0毫米)。另外,在图11中示意的图表500呈现了使用股骨部件的深弯曲膝关节仿真的结果,其中髁表面的曲率半径在30屈度、50屈度、70屈度和90屈度处增加了5.0毫米(即从25.0毫米至26.0毫米)。
在图表200、300、400、500中,将股骨部件的中间髁(“中间”)和横向髁(“横向”)的髁最低或最远点(CLP)描绘成股骨部件相对胫骨支承定位的表示。同样地,向下倾斜的线表示胫骨支承上股骨部件的向后滚动以及向上倾斜的线表示胫骨支承上股骨部件的前向平移。
如在图表200、300、400、500中所示意的,在每个实施例中对股骨部件的前向滑动进行延迟直到在大约100屈度之后;以及将前向平移量限制到小于大约1毫米。尤其是,通过在更早屈度处髁表面的曲率半径更大量的增加来促进胫骨支承上股骨部件的“向后滚动”。当然,曲率半径中的增加量和在该处引入这样的增加的屈度受到诸如患者膝关节的解剖学关节空隙、胫骨支承的尺寸和相似因素的限制。无论如何,基于图表200、300、400、500中记录的仿真,胫骨支承上股骨部件的反常前向平移可以通过在早于中间屈膝过程中增加股骨部件的髁表面的曲率半径得以减少或另外延迟。
相应地,参照回到图6和7,矢状面中髁表面100由大量弯曲表面片段102、104、106、108部分地形成。每个弯曲平面片段的矢状端与髁表面100的任一邻接弯曲表面片段的矢状端相切。每个弯曲表面片段102、106、108由各自曲率半径来限定。尤其是,弯曲表面片段102由曲率半径R1来限定,弯曲表面片段106由曲率半径R3来限定,而弯曲表面片段108由曲率半径R4来限定。另外,如下面更详细讨论的,弯曲表面片段104设计为从第一曲率半径R1到第二曲率半径R2的渐变。为此,弯曲表面片段104由多个弯曲表面片段110、120限定,其中每个由单独的曲率半径R5限定。
如上所讨论的,将股骨部件12的髁表面100构造成弯曲表面片段106的曲率半径R3大于弯曲表面片段104的曲率半径R2。在一个实施例中,曲率半径R3比曲率半径R2大0.5毫米或更多。在另一个实施例中,曲率半径R3比曲率半径R2大2毫米或更多。另外在另一个实施例中,曲率半径R3比曲率半径R2大2毫米或更多。在一特殊实施例中,曲率半径R3比曲率半径R2大至少5毫米或更多。但是可以理解的是,R2和R3之间曲率半径的特定增加可基于或由在一些实施例中股骨部件12的特定尺寸来决定。
每个弯曲表面片段102、104、106、108在通过不同的屈度范围接触胫骨支承14的支承面42(或44)。例如,弯曲表面片段102从更早的屈度θ1延伸至更晚的屈度θ2。弯曲表面片段104从屈度θ2延伸至更晚的屈度θ3。弯曲表面片段106从屈度θ3延伸至更晚的屈度θ4。
例如,在一个实施例中,弯曲表面片段102从大约-10屈度(即伸展过度10度)的屈度θ1延伸至大约5屈度的屈度θ2。弯曲表面片段104从大约5屈度的屈度θ2延伸至大约65屈度的屈度θ3。弯曲表面片段106从大约65屈度的屈度θ3延伸至大约90屈度的屈度θ4,而弯曲表面片段108从大约90屈度的屈度θ4延伸至大约104屈度的屈度θ5。
但是可以理解的是,弯曲表面片段102、104、106、108的每一个可以从不同于上面所讨论的屈度延伸。例如,弯曲表面片段102、104、106、108延伸的特殊屈度可以基于或另外基于诸如股骨部件10的类型(如十字保持或后稳定化)、股骨部件10的尺寸和/或相似的来确定。
如上所讨论的,弯曲表面片段104设计为从曲率半径R1到曲率半径R2的渐变。为此,如图5所示意的一个实施例中,弯曲表面片段104由多个弯曲表面片段110限定。在图5示意的实施例中,弯曲表面片段104由6个弯曲表面片段110A、110B、110C、110D、110E、110F限定,但在其它实施例中,也可以由更多或更少的弯曲表面片段110来限定或另外包括更多或更少的弯曲表面片段110。弯曲表面片段110的特定使用数量可以基于例如弯曲表面片段104对应的角度大小。
髁表面100的每个弯曲表面片段110通过不同的屈度范围与胫骨支承14的支承面42(或44)接触。例如,弯曲表面片段110A从屈度θ2延伸到更后的屈度θC1,弯曲表面片段110B从屈度θC1延伸到更后的屈度θC2,弯曲表面片段110C从屈度θC2延伸到更后的屈度θC3,弯曲表面片段110D从屈度θC3延伸到更后的屈度θC4,弯曲表面片段110E从屈度θC4延伸到更后的屈度θC5,以及弯曲表面片段110F从屈度θC5延伸到更后的屈度θ3。
在图5示意的实施例中,每个弯曲表面片段110延伸基本上相等的屈度。即,θ2与θC1之间、θC1与θC2之间、θC2与θC3之间、θC3与θC4之间、θC4与θC5之间以及θC5与θ3之间的屈度基本上相等。在特定的实施例中,每个弯曲表面片段110延伸大约10度。但是,在其它实施例中,每个弯曲表面片段110可以延伸更大或更小的量。特别地,在一个实施例中,每个弯曲表面片段从大约1度延伸(即相对的角)到大约15度。
每个弯曲表面片段110由曲率半径R5限定。即,弯曲表面片段110A由曲率半径R5A限定,弯曲表面片段110B由曲率半径R5B限定,弯曲表面片段110C由曲率半径R5C限定,弯曲表面片段110D由曲率半径R5D限定,弯曲表面片段110E由曲率半径R5E限定,弯曲表面片段110F由曲率半径R5F限定。每个曲率半径R5小于(即具有更短的长度)在前邻近的曲率半径R5。即,R5F小于R5E,R5E小于R5D,R5D小于R5C,R5C小于R5B,R5B小于R5A。例如,在一个实施例中,每个曲率半径R5可以具有小于在前邻近的曲率半径R5大约0.1毫米至大约5毫米范围内的量的长度。但是,在其它实施例中,每个曲率半径R5可以具有小于在前邻近的曲率半径R5大于或小于该值的量的长度。每个曲率半径R5的特定长度可基于特定应用、弯曲表面片段104的长度以及定义的方程式和/或相似的来确定。
现在参见图7,在另一个实施例中,弯曲表面片段104可由多个弯曲表面片段120形成,其中每个弯曲表面片段120可以延伸不同的度数(即不同大小的对应角)。例如,在图7所示意的实施例中,弯曲表面片段104由10个弯曲表面片段120A、120B、120C、120D、120E、120F、120G、120H、120I、120J限定。弯曲表面片段120A从屈度θ1延伸到更后的屈度θC1,弯曲表面片段120B从屈度θC1延伸到更后的屈度θC2,弯曲表面片段120C从屈度θC2延伸到更后的屈度θC3,弯曲表面片段120D从屈度θC3延伸到更后的屈度θC4,弯曲表面片段120E从屈度θC4延伸到更后的屈度θC5,以及弯曲表面片段120F从屈度θC5延伸到更后的屈度θC6,弯曲表面片段120G从屈度θC6延伸到更后的屈度θC7,弯曲表面片段120H从屈度θC7延伸到更后的屈度θC8,弯曲表面片段120I从屈度θC8延伸到更后的屈度θC9,弯曲表面片段120J从屈度θC9延伸到更后的屈度θ3。
如上讨论的,每个弯曲表面片段120延伸不同的屈度。即,θ2与θC1之间、θC1与θC2之间、θC2与θC3之间、θC3与θC4之间、θC4与θC5之间以及θC5与θC6、θC6与θC7之间、θC7与θC8之间、θC8与θC9之间、θC9与θ3之间的屈度均不相同。在一些实施例中,每个弯曲表面片段120对应的角小于在前邻近片段120对应的角。例如,在图7示意的实施例中,弯曲表面片段120A延伸大约10度,弯曲表面片段120B延伸大约9度,弯曲表面片段120C延伸大约8度,弯曲表面片段120D延伸大约7度,弯曲表面片段120E延伸大约6度,弯曲表面片段120F延伸大约5度,弯曲表面片段120G延伸大约4度,弯曲表面片段120H延伸大约3度,弯曲表面片段120I延伸大约2度,弯曲表面片段120J延伸大约1度。
虽然在图7所示意的实施例中每个弯曲表面片段120对应的角比在前邻近的片段120小1度,但是在其它实施例中,弯曲表面片段120可以对应小于在前邻近的片段120的1个度数的角。另外,在其它实施例中,每个弯曲表面片段120对应的角可以大于在前邻近的片段120对应的角。例如,在一些实施例中,每个弯曲表面片段120对应的角可以大于在前邻近的片段120对应的角大约0.5、1或更大的度数。而且,在一些实施例中,每个弯曲表面片段120对应的角可以有不同的大小。这样,在一些实施例中,每个弯曲表面片段120可以大于或小于在前邻近的弯曲表面120。
关于股骨部件12的单一髁52、54,上面已经对股骨部件12的髁表面100的整个形状和尺寸进行了描述。应该理解的是,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。即,每个髁52、54可以具有髁表面100,该髁表面100具有此处描述的特征但与另一个髁52、54不对称。
而在附图和前面描述中已经对本公开进行了示意和描述,这样的示意和描述在特征上考虑为例证性的而非限制性的,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期望得以保护。
本公开的大量优点起于在此描述的装置和部件的各种特征。要注意的是,本公开的装置和部件的可替代实施例可以不包括所有表述的特征,但仍从这种特征的至少一些优点中受益。那些本领域的技术人员可以容易地设计他们自己的组合本发明一个或多个特征的装置和部件的实现形式并且落入由所附权利要求限定的本公开的精神和范围内。

Claims (10)

1.—种整形外科膝关节假体,其包括
股骨部件,具有在矢状面中弯曲的髁表面;以及
胫骨支承,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面,
其中,所述髁表面(i)在所述髁表面上第一接触点处以小于30度的第一屈度接触所述支承面,(ii)在所述髁表面上的第二接触点处以大于45度的第二屈度来接触所述支承面,(iii)在所述髁表面上的第三接触点处以大于所述第二屈度的第三屈度来接触所述支承面,
其中所述矢状面中所述髁表面在所述第一接触点处具有第一曲率半径,在所述第二接触点处具有第二曲率半径,以及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,
其中在第一接触点和第二接触点之间的所述矢状面中所述髁表面包括多个弯曲表面片段,每个弯曲表面片段具有不同的曲率半径。
2.如权利要求1所述的整形外科膝关节假体,其中所述多个弯曲表面片段包括最前弯曲表面片段,所述最前弯曲表面片段的曲率半径具有大于所述多个弯曲表面片段中的其它任何弯曲表面片段的曲率半径的长度。
3.如权利要求2所述的整形外科膝关节假体,其中在所述最前弯曲表面片段之后的每个弯曲表面片段的曲率半径的长度小于在前邻近的弯曲表面片段的曲率半径。
4.如权利要求3所述的整形外科膝关节假体,其中在所述最前弯曲表面片段之后的每个弯曲表面片段的曲率半径的长度比在前邻近的弯曲表面片段的曲率半径的长度小0.1毫米至5毫米范围内的距离。
5.如权利要求4所述的整形外科膝关节假体,其中在所述最前弯曲表面片段之后的每个弯曲表面片段的曲率半径的长度比在前邻近的弯曲表面片段的曲率半径的长度小1毫米至3毫米范围内的距离。
6.如权利要求5所述的整形外科膝关节假体,其中在所述最前弯曲表面片段之后的每个弯曲表面片段的曲率半径的长度比在前邻近的弯曲表面片段的曲率半径的长度小1毫米。
7.如权利要求1所述的整形外科膝关节假体,其中所述多个弯曲表面片段的每一个对应一个相应的角,所述多个弯曲表面片段对应的每个角大致相等。
8.如权利要求1所述的整形外科膝关节假体,其中(i)所述多个弯曲表面片段包括最前弯曲表面片段以及(ii)每个所述多个弯曲表面片段对应一个相应的角,由每个在最前弯曲表面片段之后的弯曲表面片段对应的角小于由在前邻近的弯曲表面片段对应的角。
9.如权利要求8所述的整形外科膝关节假体,其中所述由每个在最前弯曲表面片段之后的弯曲表面片段对应的角比由在前邻近的弯曲表面片段对应的角小0.5度至5度范围内的量。
10.如权利要求1所述的整形外科膝关节假体,其中:(i)所述多个弯曲表面片段包括最前弯曲表面片段以及(ii)每个所述多个弯曲表面片段对应一个相应的角,由每个在最前弯曲表面片段之后的弯曲表面片段对应的角大于由在前邻近的弯曲表面片段对应的角。
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