CN101675901B - 具有可控制髁屈曲度的骨科股骨部件 - Google Patents

具有可控制髁屈曲度的骨科股骨部件 Download PDF

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CN101675901B
CN101675901B CN200910163980.6A CN200910163980A CN101675901B CN 101675901 B CN101675901 B CN 101675901B CN 200910163980 A CN200910163980 A CN 200910163980A CN 101675901 B CN101675901 B CN 101675901B
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CN101675901A (zh
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J·L·威廉斯
S·T·戈马
J·M·阿马科斯特
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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
    • A61F2/3859Femoral 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
    • 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
    • A61F2/38Joints for elbows or knees
    • A61F2/3886Joints for elbows or knees for stabilising knees against anterior or lateral dislocations
    • 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
    • A61F2/389Tibial 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
    • A61F2/3859Femoral components
    • A61F2002/3863Condyles fitted on an anchored base

Abstract

本发明涉及具有可控制髁屈曲度的骨科股骨部件。一种骨科膝盖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,所述曲率半径被控制以减少或延迟股骨部件相对胫骨支承件的前向平移的开始。

Description

具有可控制髁屈曲度的骨科股骨部件
相关美国专利申请的交叉参考
对2008年6月30日申请的、专利申请号为No.XX/XXXX,XX、由ChristelM.Wagner发明的、名称为“Posterior Cruciate-Retaining Orthopaedic Knee ProsthesisHaving 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、名称为“PosteriorStabilized Orthopaedic Knee Prosthesis Having Controlled Condylar Curvature”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/XXXX,XX、由Joseph G.Wyss发明的、名称为“Posterior Stabilized Orthopaedic Prosthesis”的美国专利申请;以及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 ControlledCondylar Curvature”的美国临时专利申请进行交叉参考;其每一个的整体在此引用作为参考。
技术领域
本公开通常涉及骨科假体,尤其是用在膝盖替换外科手术中的骨科假体。
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。典型的膝盖假体包括胫骨盘、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。
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,可以使用十字保持膝盖假体。
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,当股骨部件在通过屈曲范围内移动时,骨科膝盖假体可以展示多个非自然(反常的)前向平移。
在典型的骨科膝盖假体中,反常的前向平移可以在近似任何屈曲度处发生,但尤其是在后屈曲度内侧处发生。通常可以将反常的前向平移限定为胫骨支承件上股骨部件反常的相对运动,其中股骨部件和胫骨支承件之间的接触“点”关于胫骨支承件前向“滑动”。该反常的前行平移可导致关节稳定性的缺失、加速破损、反常的膝盖运动学和/或使得患者在一些活动中经历非稳定性的感觉。
发明内容
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。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等于大约0度的第一屈曲度来接触支承表面。髁表面还可以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。第二屈曲度可以大于第一屈曲度。例如,第二屈曲度可以在大约10度至大约100度的范围内。在一些特殊的实施例中,第二屈曲度为大约30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。第二曲率半径可以大于第一曲率半径至少0.5毫米。例如,第二半径可以大于第一半径至少2毫米或至少5毫米的距离。在一些实施例中,第一曲率半径和第二曲率半径之比在0.50至0.99范围内。例如,第一曲率半径和第二曲率半径之比可以在0.90至0.99范围内。
另外,在一些实施例中,髁表面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并小于大约90度。矢状面中的髁表面在第三接触点处可以具有第三曲率半径。第三曲率半径可以大于第一曲率半径并小于第二曲率半径。例如,在一些实施例中,第三半径大于第二半径至少0.5毫米。但是,在其它实施例中,第三曲率半径可以大于第一和第二曲率半径。
在一些实施例中,股骨部件的髁表面是内侧髁表面,胫骨支承件的支承表面是内侧支承表面。股骨部件可以包括在矢状面中弯曲的外侧髁表面。胫骨支承件可以包括构造成与股骨部件的外侧髁表面关节连接的外侧支承表面。在一些实施例中,外侧髁表面和内侧髁表面在矢状面中是基本上对称的。但是,在其它实施例中,外侧髁表面和内侧髁表面在矢状面中不是基本上对称的。
另外,在一些实施例中,外侧髁表面在外侧髁表面上的第一点处以第三屈曲度来接触外侧支承表面。第三屈曲度可以小于大约30度。外侧髁表面也可以在外侧髁表面上的第二点处以第四屈曲度来接触外侧支承表面。第四屈曲度可以大于第三屈曲度。另外,矢状面中的外侧髁表面可以包括第一接触点处的第一曲率半径和第二接触点处的第二曲率半径。第二曲率半径可以大于第一曲率半径至少0.5毫米。在一些实施例中,外侧髁的第二曲率半径可以不同于内侧髁的第二曲率半径。另外,在一些实施例中,第二屈曲度可以不同于第四屈曲度。此外,在一些实施例中,第一曲率半径和第二曲率半径之间的差不同于第三曲率半径和第四曲率半径之间的差。
根据另一方面,骨科膝盖假体可以包括股骨部件和胫骨支承件。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。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。第一屈曲度可以小于30度。髁表面也可以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。第二屈曲度可以大于大约30度。
在这些实施例中,矢状面中的髁表面具有第一接触点处的第一曲率半径和第二接触点处的第二曲率半径。第一曲率半径和第二曲率半径之比可以在0.80至0.99范围内。例如,第一曲率半径和第二曲率半径之比可以在0.90至0.99范围内。
根据另一方面,骨科膝盖假体可以包括股骨部件和胫骨支承件。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。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。例如,第一屈曲度可以是大约0度。髁表面也可以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。第二屈曲度可以大于大约50度。例如,在一些实施例中,第二屈曲度可以大于大约70度。
在一些实施例中,矢状面中的髁表面可以包括从第一接触点延伸至第二接触点的弯曲表面部分。可以由基本恒定的曲率半径来限定弯曲表面部分。
根据另一方面,骨科膝盖假体可以包括股骨部件。股骨部件可以包括在矢状面中弯曲的髁表面。髁表面可以包括前表面和后表面。前表面和后表面可以在髁表面上的最前点处相遇。后表面可以包括位于与最上点和最下点距离相等的最上点和中间点。矢状面中的后表面可以具有在最下点和中间点之间的后表面上的第一点处的第一曲率半径。矢状面中的后表面可以具有在第一点和最上点之间的后表面上的第二点处的第二曲率半径。第二曲率半径可以大于第一曲率半径至少0.5毫米。
附图说明
详细描述尤其涉及以下附图,其中:
图1是骨科膝盖假体的一个实施例的分解透视图;
图2是骨科膝盖假体的另一个实施例的分解透视图;
图3是大体沿着剖面线2-2截取的图1的股骨部件和胫骨支承件的一个实施例的横截面视图,其中股骨部件关节连接至第一屈曲度;
图4是图3的股骨部件和胫骨支承件的横截面视图,其中股骨部件关节连接至第二屈曲度;
图5是图3的股骨部件和胫骨支承件的横截面视图,其中股骨部件关节连接至第三屈曲度;
图6是图1的股骨部件的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是图1的股骨部件的另一个实施例的横截面视图;
图9是图1的股骨部件的另一个实施例的横截面视图;
图10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;
图11是仿真胫骨插件关于图10的仿真股骨部件的内部旋转(如图表中向上或正方向所示)的图表;
图12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;
图13是仿真胫骨插件关于图12的仿真股骨部件的内部旋转(如图表中向上或正方向所示)的图表;
图14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;
图15是仿真胫骨插件关于图14的仿真股骨部件的内部旋转(如图表中向上或正方向所示)的图表;
图16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;
图17是仿真胫骨插件关于图16的仿真股骨部件的内部旋转(如图表中向上或正方向所示)的图表;
图18是图1的股骨部件的另一个实施例的横截面视图;
图19是图1的股骨部件的另一个实施例的横截面视图;
图20是图1的股骨部件的另一个实施例的横截面视图;以及
图21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
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。
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。
现在参照图1,在一个实施例中,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-铬或钛的金属材料形成,但在其它实施例中,也可以由诸如陶瓷材料、聚合物材料、生物工程材料或相似的其它材料形成。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。在图1的示意性实施例中,将胫骨支承件14实施为旋转或移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。
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。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的互补杆。
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。在示意性实施例中,其中将胫骨支承件14实施为旋转或移动胫骨支承件,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,将胫骨支承件14构造成绕着由杆36限定的轴相对于胫骨盘16旋转。在实施例中,其中将胫骨支承件14实施为固定的胫骨支承件,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。
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构造成容纳或以其他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。
将图1的示意性骨科膝盖假体10实施为后十字保持式(posteriorretaining)膝盖假体。即,将股骨部件12实施为后十字保持式膝盖假体并将胫骨支承件14实施为后十字保持胫骨支承件14。但是,在其它实施例中,如图2所示的,可以将骨科膝盖假体10实施为后十字牺牲式(posterior sacrificing)膝盖假体。
在这样的实施例中,将胫骨支承件14实施为后稳定化胫骨支承件且包括从平台30向上延伸的脊骨60。将脊骨60定位在支承表面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具有大致凹的弯曲。但是,包括具有其它几何结构的凸轮表面66的脊骨60可以用在其它实施例中。例如,包括具有大致“S”形横截面外形的脊骨的胫骨支承件可以用在其它实施例中,诸如由Joseph G.Wyss等发明的、名称为“Posterior StabilizedOrthopaedic Prosthesis”的美国专利申请No.XX/XXX,XXX中描述的胫骨支承件,该申请在此通过引用并入本文。
另外,在这样的实施例中,将股骨部件12实施为后稳定化股骨部件且包括髁内凹口或凹槽57(而不是开口56)。将后凸轮80(以虚线示出)和前凸轮82定位在髁内凹口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件12的脊骨60的凸轮表面66接合或以其他方式接触的凸轮表面86。
应认识到的是,虽然可以将骨科膝盖假体10实施为后十字保持式或十字牺牲式膝盖假体,但是下面将关于后十字保持膝盖假体对膝盖假体10的股骨部件12和胫骨支承件14进行讨论且在剩余附图中示出,应理解的是这样的描述同样可应用于将骨科膝盖假体10实施为后十字牺牲式(后稳定化)骨科膝盖假体的实施例中。
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。
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件14上。股骨部件12的每个髁52,54包括髁表面100,其在矢状面中凸地弯曲且被构造成接触各自的支承表面42、44。例如,在图3所示的一个实施例中,当骨科膝盖假体10处在伸展中或以其他方式不屈曲(如大约0度屈曲)时,髁52的髁表面100在髁表面100的一个或多个接触点102处接触支承表面42(或关于髁54的支承表面44)。
另外,当骨科膝盖假体10通过中间屈曲度进行关节连接时,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件14。例如,在如图4所示的一个实施例中,当以中间屈曲度(如大约45度)关节连接骨科膝盖假体10时,髁表面100在髁表面100上的一个或多个接触点104处接触支承表面42。类似地,当骨科膝盖假体10关节连接至后面屈曲度(如大约70屈曲度)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处接触支承表面42。应认识到的是,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曲度来接触胫骨支承件14。但是,为了描述清晰,在图3-5中只分别示出了接触点102、104、106。
将骨科膝盖假体10构造成使得股骨部件12相对于胫骨支承件14的反常前向平移量可以减少或以其他方式延迟至更后面的(即更大)屈曲度。具体地,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。应认识到的是,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曲度,在患者的这些活动中可以减少反常前向平移的总体发生率,其中通常不会导致深度弯曲。
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,都可以发生反常前向平移。当骨科膝盖假体关节连接至较大屈曲度尤其至中间屈曲范围时,前向平移的可能性通常是增加的。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)力不能满足下面方程式时,胫骨支承件上股骨部件的反常前向平移就可发生:
T<μN            (1)
其中“T”是切向(牵引)力,“μ”是股骨部件和胫骨支承件的摩擦系数,“N”是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:
T=M/R            (2)
其中“T”是股骨部件和胫骨支承件之间的切向(牵引)力,“M”是膝盖力矩,“R”是以特殊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,方程式(2)是主导的现实中的方程式的简化形式,其没有考虑如惯性和加速度的其它因素。无论如何,方程式(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),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),胫骨支承件上股骨部件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。
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曲度范围内保持恒定和/或在早于中间屈曲度范围内增加。相比而言,典型股骨部件具有在远曲率半径处(即在大约0屈曲度处)开始降低的曲率半径。但是,已经确定,通过在早于中间屈曲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/或在预定屈曲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,对在早于中间屈曲度范围(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,使得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,则会发生反常前向平移。
相应地,在如图6-8所示的一些实施例中,股骨部件12的髁表面100在早于中间屈曲度中具有从较小曲率半径R1增大至较大曲率半径R2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曲度,如下更详细讨论。
确定曲率半径R2和曲率半径R3之间的增加量,以及在该处产生这样增加的髁表面100上的屈曲度,以影响反常前向平移的产生。使用LifeMOD/KneeSim,version 1007.1.0 Beta 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曲度和中间屈曲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毫米或更大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。
例如,在图10和11中示出的图表200、250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,在图12和13中示出的图表300、350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)。在图14和15中示出的图表400、450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)。另外,在图16和17中示出的图表500、550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)。
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,向下倾斜的线表示胫骨支承件上股骨部件的向后滚动,向上倾斜的线表示胫骨支承件上股骨部件的前向平移。在图表250、350、450、550中,关于每个屈曲度,描绘了每个示意性实施例的仿真股骨部件和胫骨支承件之间的用度数来表示的相对内外旋转量。图表250、350、450、550中的向上倾斜线对应于胫骨关于股骨的内旋转量(或股骨关于胫骨的外旋转)。
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胫骨支承件上股骨部件的“向后滚动”。另外,如图表250、350、450、550中所示的,通过在更早屈曲度处髁表面的曲率半径中更大量的增加来增加股骨部件和胫骨支承件之间内外旋转量。当然,曲率半径中的增加量和在该处引入这样的增加的屈曲度受到诸如患者膝盖的解剖学关节空隙、胫骨支承件的尺寸和相似因素的限制。无论如何,基于图表200、250、300、350、400、450、500、550中记录的仿真,胫骨支承件上股骨部件的反常前向平移可以通过在早于中间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。
相应地,参照回到图6-9,在一个实施例中,矢状面中的髁表面100由大量弯曲表面部段102、104部分地形成。每个弯曲平面部段102、204的矢状端与髁表面100的任一邻接弯曲表面部段的矢状端相切。每个弯曲表面部段102、104由各自曲率半径来限定。尤其地,弯曲表面部段102由曲率半径R1限定,弯曲表面部段104由曲率半径R2限定。
如上所讨论的,将股骨部件12的髁表面100构造成弯曲表面部段104的曲率半径R2大于弯曲表面部段102的曲率半径R1。在一个实施例中,曲率半径R2比曲率半径R1大0.5毫米或更多。在另一个实施例中,曲率半径R2比曲率半径R1大1毫米或更多。另外在另一个实施例中,曲率半径R2比曲率半径R1大2毫米或更多。在一特殊实施例中,曲率半径R2大于曲率半径R3在大约0.5毫米至大约5毫米范围内的距离。
但是应认识到的是,在一些实施例中,R1和R2之间曲率半径的具体增加可以基于或由股骨部件12的特殊尺寸决定。例如,在一些实施例中,R1和R2之间曲率半径的增加可以基于R1的尺寸。即,在一些实施例中曲率半径R1和曲率半径R2之比可以低于预定阈值或在目标值的特定范围内。例如,在一些实施例中,曲率半径R1和曲率半径R2之比在0.80和0.99之间。在一个特殊实施例中,曲率半径R1和曲率半径R2之比在0.90和0.99之间。
每个弯曲表面部段102、104通过不同的屈曲度范围接触胫骨支承件14的支承表面42(或44)。例如,弯曲表面部段102从更早的屈曲度θ1延伸至更后的屈曲度θ2。弯曲表面部段104从屈曲度θ2延伸至更后的屈曲度θ3。具体屈曲度θ1、θ2和θ3可以在各实施例之间变化并基于诸如骨科假体类型(如十字保持或后稳定化)、骨科假体的其它部件的定位(如股骨部件12的凸轮的定位)、股骨凸轮的尺寸、胫骨支承件14的曲率、患者骨骼等标准。例如,在一个实施例中,如图6所示,弯曲表面部段102从大约0度的屈曲度θ1延伸至大约30度的屈曲度θ2。弯曲表面部段104从大约30度的屈曲度θ2延伸至大约110度的屈曲度θ3。
如上所讨论的,具体屈曲度θ1、θ2和θ3可以基于具体实施例和股骨部件12的其它特征得以确定。例如,更大屈曲度θ3可以被确定或以其他方式基于期望而定,以允许股骨部件12的最后-上端110“围成”圈。这样的构造可以为了在患者关节间隙内定位而适当地调节尺寸或配置股骨部件12。股骨部件12的端部110可以由多个附加曲率半径来形成,其从屈曲度θ3处开始。这样,具体屈曲度θ3可以被确定或基于如下屈曲度,即在该屈曲度处附加的曲率半径必须开始形成所期望的端部110。
在另一个实施例中,如图7所示,弯曲表面部段102从大约0度的屈曲度θ1延伸至大约50度的屈曲度θ2。弯曲表面部段104从大约50度的屈曲度θ2延伸至大约110度的屈曲度θ3。另外,在另一个实施例中,如图8所示,弯曲表面部段102从大约0度的屈曲度θ1延伸至大约70度的屈曲度θ2。弯曲表面部段104从大约70度的屈曲度θ2延伸至大约110度的屈曲度θ3。在另一个示意性实施例中,如图9所示,弯曲表面部段102从大约0度的屈曲度θ1延伸至大约90度的屈曲度θ2。弯曲表面部段104从大约90度的屈曲度θ2延伸至大约110度的屈曲度θ3。
再次应认识到的是,图6-9的实施例是示意性的实施例,在其它实施例中,每个弯曲表面部段102、104可以从不同于以上关于图6-9所示和所讨论的屈曲度延伸。例如,在图6-9的每个实施例中,虽然弯曲表面部段102示出为在大约0度的屈曲度开始,但是在其它实施例中,弯曲表面部段102可以从0度之前的屈曲度(即伸展过度的屈曲度)开始。
现在参照图18,应认识到的是,即使图6-9的示意性实施例仅包括曲率半径的一个增加(即R1和R2之间),在其它实施例中,髁表面可以包括任何数量的曲率半径增加。例如,在图18所示的一个实施例中,髁表面100可以由多个弯曲表面部段600、602、604、606、608形成,其每一个的矢状端与邻接的弯曲表面部段相切。弯曲表面部段600从更前的屈曲度θ1延伸至更后的屈曲度θ2。弯曲表面部段602从屈曲度θ2延伸至更后的屈曲度θ3。弯曲表面部段604从屈曲度θ3延伸至更后的屈曲度θ4。弯曲表面部段606从屈曲度θ4延伸至更后的屈曲度θ5。弯曲表面部段608从屈曲度θ5延伸至更后的屈曲度θ6。
每个弯曲表面部段600、602、604、606、608由各自曲率半径限定。尤其地,弯曲表面部段600由曲率半径R1限定,弯曲表面部段602由曲率半径R2限定,弯曲表面部段604由曲率半径R3限定,弯曲表面部段606由曲率半径R4限定,弯曲表面部段608由曲率半径R5限定。曲率半径R2大于曲率半径R1。类似地,曲率半径R3大于曲率半径R2。曲率半径R4大于曲率半径R3。以及,曲率半径R5大于曲率半径R4。以此方式,髁表面100由多个弯曲表面部段形成,每个具有大于邻接的前弯曲表面部段的曲率半径。而且,图18中所示出的实施例只是一个示意性实施例。在其它实施例中,髁表面100可以由更多个或更少个具有相对前向邻接弯曲表面部段增加的曲率半径的弯曲表面部段形成。
现在参照图19,髁表面100可以包括在早于中间屈曲度中曲率半径的增加和曲率半径的减少。即,在一些实施例中,髁表面100的曲率半径可以从初始曲率半径初始地增加到增加的曲率半径并随后降低至大于在后屈曲之前的初始半径(如在大约90屈曲度之前)的降低的曲率半径。
例如,在图19所示的一个实施例中,髁表面100由多个弯曲表面部段700、702、704形成,其每一个的矢状端与邻接的弯曲表面部段相切。弯曲表面部段700从更前的屈曲度θ1延伸至更后的屈曲度θ2。弯曲表面部段702从屈曲度θ2延伸至更后的屈曲度θ3。弯曲表面部段704从屈曲度θ3延伸至更后的屈曲度θ4。
每个弯曲表面部段700、702、704由各自曲率半径限定。尤其地,弯曲表面部段700由曲率半径R1限定,弯曲表面部段702由曲率半径R2限定,弯曲表面部段704由曲率半径R3限定。曲率半径R2大于曲率半径R1。曲率半径R3小于曲率半径R2而大于曲率半径R1。以此方式,髁表面100的曲率半径初始从R1增加至R2,以及随后降低至R3。但是,因为R3仍旧大于远处半径R1,如上详细讨论的,股骨部件12的反常前向平移可以减少或延迟。
另外,如上所讨论的,R1和R2之间以及R1和R3之间的具体增加量可以在各实施例之间变化并基于多个变化标准中的一个或多个,所述标准诸如骨科假体(如十字保持或后稳定化)、骨科假体的其它部件的定位(如股骨部件12的凸轮的定位)、股骨凸轮的尺寸、胫骨支承件14的曲率、患者的骨骼等。在一个具体的实施例中,每个曲率半径R2、R3大于曲率半径R1至少0.5毫米。
现在参照图20,控制髁表面100的曲率半径的另一方式是通过早于中间屈曲度而维持曲率半径。如上所讨论的,典型股骨部件具有在远曲率半径(即在大约0屈曲度)处开始降低的曲率半径。但是,已经确定在早于中间屈曲度的整个预定范围内维持相对恒定的曲率半径(即不减小曲率半径)可以减少或延迟股骨部件12的反常前向平移。
相应地,在图20所示的一个实施例中,髁表面100可以由弯曲表面部段800形成。弯曲表面部段800从更前的屈曲度θ1延伸至更后的屈曲度θ2。弯曲表面部段800由恒定的或基本恒定的曲率半径R1限定。在一个示意性实施例中,弯曲表面部段800对向大约110度的角,但在其它实施例中可以是更大或更小的。例如,在一个具体实施例中,弯曲表面部段800对向至少50度的角。另外,如上所讨论的,具体屈曲度θ1、θ2可以基于多个标准中的一个或多个,所述标准诸如骨科假体类型(如十字保持或后稳定化)、骨科假体的其它部件的定位(如股骨部件12的凸轮的定位)、股骨凸轮的尺寸、胫骨支承件14的曲率、患者的骨骼等。
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21所示出的,股骨部件12可以包括具有髁表面900的第二髁52、54,其部分地由多个弯曲表面部段902、904限定。弯曲表面部段902从更前的屈曲度θ4延伸至更后的屈曲度θ5。弯曲表面部段904从屈曲度θ5延伸至更后屈曲度θ6。弯曲表面部段902由曲率半径R3限定,弯曲表面部段904由曲率半径R4限定。
这样,在髁52、54是对称的的实施例中,屈曲度θ4基本上等于屈曲度θ1,屈曲度θ5基本上等于屈曲度θ2,屈曲度θ6基本上等于屈曲度θ3。另外,曲率半径R3基本上等于曲率半径R1,曲率半径R4基本上等于曲率半径R2。
但是在其它实施例中,髁52、54是非对称的。这样,屈曲度θ4可以不同于屈曲度θ1。另外或可替代地,屈曲度θ5可以不同于屈曲度θ2。即,在髁52、54之间,从曲率半径R1至R2以及从曲率半径R3至R4的增加在不同的屈曲度处都可以发生。而且,屈曲度θ6可以不同于屈曲度θ3。另外,在髁52、54是对称的实施例中,曲率半径R3可以不同于曲率半径R1和/或曲率半径R4可以不同于曲率半径R2。
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被认为是示例性的而并不限制特征,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。
本公开的多个优点来自本文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描述的特征,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,其包括:
股骨部件,其具有在矢状面中弯曲的髁表面;以及
胫骨支承件,其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)在所述髁表面上第一接触点处以等于0度的第一屈曲度接触所述支承表面,(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所述第一屈曲度,
其中(i)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(ii)所述第二曲率半径大于所述第一曲率半径至少0.5毫米。
2.如权利要求1所述的骨科膝盖假体,其中所述第二屈曲度在10度至100度范围内。
3.如权利要求1所述的骨科膝盖假体,其中所述第二曲率半径大于所述第一曲率半径至少2毫米的距离。
4.如权利要求1所述的骨科膝盖假体,其中所述第一曲率半径和所述第二曲率半径之比在0.50至0.99范围内。
5.如权利要求4所述的骨科膝盖假体,其中所述第一曲率半径和所述第二曲率半径的比在0.90至0.99范围内。
6.如权利要求1所述的骨科膝盖假体,
其中所述髁表面在所述髁表面上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而小于90度,
其中(i)所述矢状面中所述髁表面在第三接触点处具有第三曲率半径,以及(ii)所述第三曲率半径大于所述第一曲率半径并小于所述第二曲率半径。
7.如权利要求1所述的骨科膝盖假体,
其中所述髁表面在所述髁表面上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而小于90度,
其中(i)所述矢状面中所述髁表面在所述第三接触点处具有第三曲率半径,以及(ii)所述第三曲率半径大于所述第二曲率半径。
8.如权利要求1所述的骨科膝盖假体,其中:
(i)所述股骨部件的所述髁表面是内侧髁表面,所述胫骨支承件的所述支承表面是内侧支承表面,
(ii)所述股骨部件还包括在矢状面中弯曲的外侧髁表面,以及
(iii)所述胫骨支承件还包括构造成与所述股骨部件的外侧髁表面关节连接的外侧支承表面。
9.如权利要求8所述的骨科膝盖假体,其中所述外侧髁表面和所述内侧髁表面在矢状面内基本上对称。
10.如权利要求8所述的骨科膝盖假体,
其中所述外侧髁表面(i)在所述外侧髁表面上第三接触点处以第三屈曲度接触所述外侧支承表面,所述第三屈曲度小于30度,以及(ii)在所述外侧髁表面上第四接触点处以第四屈曲度接触所述外侧支承表面,所述第四屈曲度大于所述第三屈曲度,以及
其中(i)所述矢状面中的外侧髁表面在所述第三接触点处具有第三曲率半径,(ii)所述矢状面中的外侧髁表面在所述第四接触点处具有第四曲率半径,以及(iii)所述第四曲率半径大于所述第三曲率半径至少0.5毫米。
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