CN108135701A - 包括胫骨承载组件的假体系统 - Google Patents

包括胫骨承载组件的假体系统 Download PDF

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CN108135701A
CN108135701A CN201680061268.3A CN201680061268A CN108135701A CN 108135701 A CN108135701 A CN 108135701A CN 201680061268 A CN201680061268 A CN 201680061268A CN 108135701 A CN108135701 A CN 108135701A
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bearing assembly
shin bone
compartment
bone bearing
femoral component
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CN108135701B (zh
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N·德鲁里
J·布莱洛克
S·E·怀特
C·B·格雷
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Zimmer GmbH
Zimmer Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2/389—Tibial components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/30934—Special articulating surfaces

Abstract

根据一个实施例，公开了胫骨承载组件，用于在膝盖置换手术中连接股骨组件的内侧髁和外侧髁。胫骨承载组件可包括远端面和与远端面相对置的关节面。关节面能包括内侧间室和外侧间室，配置成分别连接股骨组件的内侧髁和外侧髁。外侧间室可具有外侧关节轨迹，其具有外侧前后范围。外侧关节轨迹可包含沿着外侧间室近端面的多个最远点，其在股骨组件回滚期间与外侧髁接触。内侧间室可在构型上不同于外侧间室且可具有约9mm‑约13mm的前唇高度。

Description

包括胫骨承载组件的假体系统
优先权请求
本申请要求2015年9月21日提交的美国临时专利申请序列号62/221,461的权益，还要求2016年3月16日提交的美国临时专利申请序列号62/309,046的权益，在此要求的各申请优先权的权益以及各申请通过引用全文纳入本文。
技术领域
本主题涉及矫形外科手术，更具体涉及用于膝关节成形术的假体、系统和方法。
发明背景
矫形外科手术和假体通常用于修复和/或置换人体中受损骨头和组织。例如，膝关节成形术能用于通过修复股骨和/或胫骨的受损或患病的关节面恢复自然膝盖功能。在膝关节内割开一个切口以暴露含关节的骨头。切割指南用于引导移出待置换的关节面。假体用于复制(replicate)关节面。膝盖假体可以包括植入股骨远端的股骨组件，其与胫骨承载组件和植入胫骨近端的胫骨组件连接(articulate)以复制健康天然膝盖的功能。已知不同类型的关节成形术，包括全膝关节成形术，其中关节的所有连接间室(articulatingcompartment)用假体组件修复。
发明内容
本公开一般涉及临时胫骨假体、系统和方法。此外，本发明者意识到，如在全膝关节成形术中，对于膝假体而言，相对于外侧髁，股骨组件的内侧髁能在膝关节屈曲期间经历更少的前后平移。就股骨组件而言，这能导致股骨回滚期间的外旋转(rotation)和内侧绕轴运动(pivoting motion)。考虑到这些运动学，本发明者设计有内和外侧间室的胫骨植入物，其能以更理想方式适应股骨组件的这类运动。因此，本发明者建议用于胫骨承载组件的内侧间室以及胫骨承载组件的外侧间室，所述内侧间室能配制成提供与股骨组件内侧髁的高度一致性和约束性，可以使所述外侧间室成形以在深屈曲中帮助股骨组件外侧髁外部回滚。
内侧稳定性
鉴于上述情况，本发明者设计了胫骨承载组件家族，其可以具有至少11种不同标准尺寸以在与可以具有至少9种不同标准尺寸的胫骨组件家族和可以具有至少12种不同标准尺寸的股骨组件家族一起使用时获得更兼容的组合。由于组件数量和各家族不同尺寸之间的所设计的兼容性，胫骨承载组件家族的至少11种不同标准尺寸的24种组合能与股骨组件家族的至少12种不同标准尺寸兼容而一起可操作使用。更具体地，由于股骨组件与胫骨承载组件那么多不同尺寸之间的所设计的相容性，在最坏情况下，在伸展中(inextension)，股骨组件与胫骨承载组件之间的一致性能具有最多1.1:1的一致比例，不同尺寸胫骨承载组件与不同尺寸股骨组件之间超过半数(54％)的一致性能具有1:1的内侧一致性比例。
本发明者进一步认识到，通过增加股骨组件内侧髁与胫骨承载组件内侧间室之间的一致性，随着接触面积增加能实现更高的内侧髁内侧稳定度。因此，本发明者建议能促进更高一致性(和因而更大接触面积)的胫骨承载关节面构造和示例，其中来自各组件家族的不同尺寸股骨和胫骨承载组件的相容性组合能联合以实现更需要、更大的接触面积。这类示例可实现某一排列，其中最少31％的内侧间室总表面积能接触0°屈曲的股骨组件，最少13％的内侧间室总表面积能接触45°屈曲的股骨组件。根据进一步的示例，排列中平均54％的内侧间室总表面积能接触0°屈曲的股骨组件且平均38％的内侧间室总表面积能接触45°屈曲的股骨组件。本发明者还建议用于胫骨承载组件内侧间室的前唇高度在9mm-13mm之间(取决于胫骨承载组件尺寸)。此前唇高度能提供更高的前半脱位阻力以提供对股骨组件内侧髁更大的约束。
外侧运动性
为帮助股骨组件外侧髁相对于胫骨承载组件外侧间室的更高运动性，本发明者建议胫骨承载组件外侧间室的矢状几何可以配制成具有2个不同的半径，包括前半径和后半径。当在横截面上观察时，后半径绕内侧间室驻留点(关节面上的拐点，在所述拐点关节面具有最深的远端范围(extent))成弧线以帮助股骨组件外旋转用于深屈曲。另外，在一些示例中，可以定位外侧髁驻留点以进一步帮助股骨组件外侧髁回滚用于深屈曲。具体地，对于前胫骨斜率为0°的不同尺寸胫骨承载组件家族，外侧驻留点的前后位置作为胫骨承载组件的总前后范围的百分数，可以是从胫骨承载组件最前点到最后点所测量的总前后范围的约65％-约69％。
为进一步阐明本文公开的设备和洗脱，提供以下非限制性实施例：
实施例1是胫骨承载组件，用于在膝盖置换手术中与股骨组件内侧髁和外侧髁连接，该胫骨承载组件可以包括远端面和与远端面相对置的关节面。关节面能包括内侧间室和外侧间室，配置成分别连接股骨组件的内侧髁和外侧髁。外侧间室可具有外侧关节轨迹，所述外侧关节轨迹具有外侧前后范围，外侧关节轨迹可以包括沿着外侧间室近端面的多个最远点，其在股骨组件回滚期间与外侧髁接触。内侧间室可在构型上不同于外侧间室且可以具有约9mm-约13mm的前唇高度。
实施例2中，实施例1的主题可任选地包括，外侧间室可以具有前部和后部，当投影到胫骨承载组件横截面上时，前部可以限定外侧关节轨迹为名义上的直线，当投影到胫骨承载组件横截面上时，后部能以有朝向内侧间室的曲线限定外侧关节轨迹。
实施例3中，实施例2的主题可任选地包括，外侧间室在前部中具有第一矢状半径(sagittal radius)且在后部中具有第二矢状半径。
实施例4中，实施例1-3中任意一个或多个的主题可任选地包括，内侧间室具有内侧关节轨迹，所述内侧关节轨迹具有内侧前后范围，所述内侧前后范围不同于外侧前后范围。内侧关节轨迹能包括沿着内侧间室近端面的多个最远点，其在股骨组件回滚期间被内侧股骨髁接触。当投影到承载组件横截面上时，内侧间室能定义内侧关节轨迹作为名义上的直线且内侧关节轨迹具有单一矢状半径。
实施例5中，实施例4的主题可任选地包括，内侧间室可以配置成具有处在从胫骨承载组件最前点到最后点所测量的胫骨承载组件总前后范围的约61％-约66％的距离的内侧驻留点。
实施例6中，实施例1-4中任意一个或多个的主题可任选地包括，外侧间室可以配置成具有处在从胫骨承载组件最前点到最后点所测量的胫骨承载组件总前后范围的约65％-约69％的距离的外侧驻留点。
实施例7中，实施例1-6中任意一个或多个的主题可任选地包括，其中相对于内侧髁配置所述内侧间室，股骨组件0°屈曲时，所述内侧间室总表面积的约31％-约63％与股骨组件内侧髁接触。
实施例8中，实施例1-6中任意一个或多个的主题可任选地包括，内侧间室可以配置成与内侧髁具有约1.1一致比-约1.1:1一致比，一致比可以包括内侧间室矢状半径与内侧髁矢状半径之间的类似性之比。
实施例9是用于膝关节成形术的系统，其可以包括具有至少12种不同标准尺寸的股骨组件家族和具有至少11种不同标准尺寸的胫骨承载组件家族。各股骨组件可包括内侧髁和外侧髁。各胫骨承载组件可包括远端面和与远端面相对置的关节面。关节面可以包括内侧间室和外侧间室，配置成分别连接股骨组件的内侧髁和外侧髁。胫骨承载组件家族能配置成胫骨承载组件家族的至少11种不同标准尺寸的24种组合能够与股骨组件家族至少12种不同标准尺寸及胫骨组件家族至少9种不同标准尺寸兼容而一起可操作使用。
实施例10中，实施例9的主题可任选地包括，股骨组件家族和胫骨承载组件家族可以配置成股骨组件0°屈曲时内侧间室总表面积的约31％-约63％与股骨组件内侧髁接触。
实施例11中，实施例9-10中任意一个或多个的主题可选包括内侧间室，其能配置成与内侧髁具有约1.1一致比-约1.1:1一致比，一致比能包括内侧间室矢状半径与内侧髁矢状半径之间的类似性之比。
实施例12中，实施例9-11中任意一个或多个的主题可任选地包括，内侧间室可以配置成具有处在从胫骨承载组件最前点到最后点所测量的胫骨承载组件总前后范围的61％-约66％的距离的内侧驻留点。
实施例13中，实施例9-12中任意一个或多个的主题可任选地包括，股骨组件家族的至少12种不同标准尺寸中的10种可以与胫骨承载组件家族的至少11种不同标准尺寸中的10种兼容而一起可操作使用。
实施例14中，实施例9-13中任意一个或多个的主题可任选地包括，股骨组件家族的至少12种不同标准尺寸中的8种可以与胫骨承载组件家族的至少11种不同标准尺寸中的6种兼容而一起可操作使用。
实施例15中，实施例9-14中任意一个或多个的主题可任选地包括，胫骨承载组件家族的至少11种不同标准尺寸中的9种可以与股骨组件家族的至少12种不同标准尺寸中不超过2种兼容，股骨组件家族的至少12种不同标准尺寸中不超过4种可以与胫骨承载组件家族至少11种不同标准尺寸中的2种兼容而一起可操作使用。
实施例16中，实施例9-15中任意一个或多个的主题可任选地包括，内侧间室可以具有约9mm-约13mm的前唇高度。
实施例17中，实施例9-16中任意一个或多个的主题可任选地包括，内侧间室具有内侧关节轨迹，所述内侧关节轨迹具有内侧前后范围，所述内侧前后范围不同于外侧前后范围。内侧关节轨迹可以包括沿着内侧间室近端面的多个最远点，其在股骨组件回滚期间与内侧股骨髁接触。当投影到承载组件横截面上时，内侧间室可以定义内侧关节轨迹为名义上的直线且内侧关节轨迹具有单一矢状半径。
实施例18是用于在膝盖置换手术中连接股骨组件内侧髁和外侧髁的胫骨承载组件，所述胫骨承载组件可以包括远端面和与远端面相对置的关节面。关节面可以包括内侧间室和外侧间室，配置成分别连接股骨组件的内侧髁和外侧髁。外侧间室可以配置成具有处在从胫骨承载组件最前点到最后点所测量的胫骨承载组件总前后范围的约65％-约69％的距离的外侧驻留点。
实施例19中，实施例18的主题可任选地包括，内侧间室构型不同于外侧间室且具有约9mm-约13mm的前唇高度。
实施例20中，实施例18-19中任意一个或多个的主题可任选地包括，外侧间室具有外侧关节轨迹，所述外侧关节轨迹具有外侧前后范围。外侧关节轨迹可以包含沿着外侧间室近端面的多个最远点，其在股骨组件回滚期间与外侧髁接触。外侧间室可以具有前部和后部，当投影到胫骨承载组件横截面上时，前部可以限定外侧关节轨迹为名义上的直线，当投影到胫骨承载组件横截面上时，后部能以朝向内侧间室的曲线限定外侧关节轨迹。
实施例21中，实施例20的主题可任选地包括，外侧间室在前部中具有第一矢状半径且在后部中具有第二矢状半径。
实施例22中，可任选地配置实施例1-21中任意一种或任意组合的设备或方法，使得所有所列举的要素或选择可使用或从中选择。
本设备和系统的这些和其它实施例和特征部分地示于以下发明详述。此综述意在提供本主题的非限制性实施例-不意在提供排他性或详尽的解释。纳入下面的详细描述以提供关于本设备和系统的进一步信息。
附图说明
附图不必然按比例绘制，如同数字能以不同角度描述类似组件。例如，具有不同字母后缀的数字能代表类似组件的不同例子。附图一般通过举例的方式而非限制方式阐明本文档讨论的各个实施例。
根据本申请实施例，图1显示有正常内侧和外侧髁运动的天然胫骨近端的示意图。
根据本申请实施例，图2显示与胫骨承载组件组装的股骨组件。
根据本申请实施例，图2A显示冠状面中图2的股骨组件和胫骨承载组件的横截面。
根据本申请实施例，图3阐明松动(laxity)包线(envelope)和图2和2A的股骨组件相对于图2和2A的胫骨承载组件的可允许的前后平移。
根据本申请实施例，图4A-4D显示图3的松动包线相对于现有技术系统的图。
根据本申请实施例，图5是胫骨承载组件近端面的俯视图，包括特征如内侧间室和外侧间室。
根据本申请实施例，图5A是图5的胫骨承载组件冠状面的剖视图。
根据本申请实施例，图5B和5C显示图5的胫骨承载组件的内侧，包括内侧间室。
根据本申请实施例，图6和6A显示图5的胫骨承载组件的外侧。
根据本申请实施例，图7显示胫骨承载组件家族相对于股骨组件、胫骨组件和胫骨承载组件家族的尺寸分级(sizing)表。
根据本申请实施例，图8显示股骨髁与胫骨承载组件间室之间接触区域的俯视图，在股骨组件不同屈曲角度显示。
发明详述
本申请涉及胫骨假体、系统和方法。例如，所述系统可以包括胫骨承载组件和股骨组件。
根据本申请实施例，图1显示天然胫骨12的近端10的示意图。天然胫骨12可以包括外侧髁14和内侧髁16。
外侧髁14可在形状和尺寸上不同于内侧髁16。图1阐明叠加于外侧髁14上的股骨外侧髁和叠加(superimposed)于内侧髁16上的股骨内侧髁的前后平移量。通常，股骨内侧髁相对于股骨外侧髁能在膝关节屈曲期间经历更少的前后平移。就天然股骨而言，这能导致股骨回滚期间的外旋转和内侧绕轴运动。图1提供实例，其中从约-5°到约120°屈曲角度，股骨内侧髁经历约1.5mm前后平移，而股骨外侧髁经历约18mm前后平移。
在全膝关节成形术(简称为“TKA”)中，股骨的内和外侧髁都可以切除。类似地，可以用切割设备切除胫骨以去除内侧关节面和外侧关节面。也可以去除其它膝盖部分如髁间隆起、ACL。根据TKA类型，特征(feature)如PCL可以是备用的或也可以去除。可以在股骨和胫骨上植入假体，提供置换的关节面。尽管所显示的参考TKA和对应植入物，本文所述技术和方法也能应用于其它膝关节成形术手术如部分膝关节成形术(例如膝关节单髁置换术)。
根据一个实施例，图2和2A显示股骨组件110与胫骨承载组件112的集合100，用于TKA。如图2所示，股骨组件110可以包括关节面114(图2中仅显示一个)和近端面116。如图2A所示，关节面114可以包括内侧髁118和外侧髁120。胫骨承载组件112可包括关节面122和远端面124。关节面122可包括内侧间室126和外侧间室128。
股骨组件110可以包括与Zimmer Biomet 膝盖系统兼容的股骨组件，该系统由Zimmer Biomet Holding,Inc.生产。股骨组件的构造多方面描述于美国专利号8,858,643、9,072,607、8,690,954、8,764,838、8,932,365和美国申请公开号2012/0323336，其公开内容通过引用全文纳入。因此，不在本文极详细地描述股骨组件110的具体特征。
如图2和2A的实施例中所示，胫骨承载组件112与股骨组件110兼容而一起可操作使用，并为此进行配置。具体地，胫骨承载组件112的关节面122可以配置成在其上接受股骨组件110的关节面114，并可以配置成允许股骨组件110以模拟天然膝盖运动学的方式相对于其移动(如考虑屈曲的股骨组件110回滚，包括前后平移)。
股骨组件110的近端面116可以配置成接受和偶联股骨的切除的远端面。如图2A所示，关节面114可包括内侧髁118和外侧髁120。关节面122可包括内侧间室126和外侧间室128。如图2A所示，内侧间室126和外侧间室128能配置成分别连接股骨组件110的内侧髁118和外侧髁120。可以安排关节面122与远端面124相对置。可以远端面124成形为连接(interface with)胫骨托件近端面(未显示)，所述胫骨托件可以固定于胫骨的切割的近端面(未显示)。
根据一个实施例，图3显示胫骨承载组件112的关节面122。尽管胫骨承载组件112显示具有允许图3和本文其它图中十字韧带保留构型的切断，但胫骨承载组件112可以有其它设计，包括其它实施例所述的后方稳定构型和/或超一致构型，其不意在用于十字韧带保留构型。
后续进一步详细讨论的关节面122的多个方面允许胫骨承载组件112给股骨组件110(图2A)的内侧髁118(图2A)提供想要的稳定性，同时额外给股骨组件110(图2A)的外侧髁120(图2A)提供想要的移动性。图3和4阐述在松动范围方面想要的稳定的内侧髁和可移动的外侧髁，并伴有对此的讨论。图5-6A和8阐述内侧和外侧承载间室126、128的构型的多个特征，并伴有对此的讨论，所述构型能在屈曲期间改善内侧髁的稳定性并额外地能提高外侧髁的移动性。尺寸分级方案示于图7，用于各家族的多种胫骨承载组件和股骨组件的尺寸分级，所用方式使得其能组合使用以更好实现想要的稳定的内侧髁和可移动的外侧髁。
图3中阐明，如圆圈130L和130M所示，从0°-120°屈曲，内侧间室126和外侧间室128具有不同的平均前后松动。如图4A-4D的曲线图所示，松动可以包括一定程度的(a degreeof)外侧髁和内侧髁前后位置变化，根据股骨组件屈曲程度绘制。图4A的曲线图150和图4B的曲线图152分别是内侧髁118和外侧髁120的图，用于图3胫骨承载组件112的十字韧带保留构型。如图4B的曲线图152所示，与市售可得膝盖组件设计相比(如图4B的区域156所示)进行测量时，内侧髁118(图2A)与胫骨承载组件112一起使用时，可相对更稳定(具有更紧的松动范围，如图4B的区域154所示)，所述设计是膝盖系统的十字韧带保留构型，由Zimmer Biomet Holdings,Inc.,Warsaw,Indiana生产。类似地，图4A的曲线图150显示，与相同市售可得膝盖系统(如图4A的区域159所示)相比进行测量时，外侧髁120(图2A)与胫骨承载组件112一起使用时，可具有更多的移动性(具有更大的松动范围，如图4A的区域158所示)。
图4C的曲线图160和图4D的曲线图162分别是外侧髁和内侧髁的图，用于本文所述胫骨承载组件的十字韧带舍弃构型。如图4D的曲线图162所示，与市售可得膝盖组件设计(如图4D的区域164所示)相比进行测量时，股骨组件的内侧髁可相对更稳定(具有更紧的松动范围，如图4D的区域166所示)，所述设计是膝盖系统的十字韧带舍弃构型，由Zimmer Biomet Holdings,Inc.,Warsaw,Indiana生产。类似地，图4C的曲线图160显示，与相同市售可得膝盖系统(如图4C的区域170所示)相比进行测量时，股骨外侧髁可具有相对更多的移动性(具有更大的松动范围，如图4C的区域168所示)。
图5、5A、5B和5C是根据本申请实施例的胫骨承载组件212视图。胫骨承载组件212与本文前述的胫骨承载组件112基本类似，且在胫骨承载组件构造(construction)方面加入进一步的细节。如图5所示，胫骨承载组件212可以包括关节面214、外围216、后部空槽(cutout)218和前部缓冲(relief)空间219。关节面214可包括内侧间室220、外侧间室222和髁间隆起224。
如前所述，当在膝盖中可操作组装时，关节面214可以与股骨组件的髁(未显示)接触。股骨组件的髁可接触内侧和外侧间室220、222。更具体地，可以配置内侧能间室220和外侧间室222(例如，形状为碟形)用于分别连接股骨组件的内侧髁和外侧髁(如图2A所示)。关节面214(本文有时称为近端面)一般可与远端面215相对置，如图5A和5C所示。外围216可以包括连接远端面215与关节面214的侧壁。如后面进一步详细解释的，内侧间室220可在构型上不同于外侧间室222。例如，相对于外侧间室222，内侧间室220可具有不同尺寸和形状。例如，外侧间室222的前后曲率可不同于内侧间室220。类似地，如图5C和图6A所示，外侧间室222的内-外侧曲率可不同于内侧间室220的内-外侧曲率。
如图5的实施例所示，外侧间室222可以具有外侧关节轨迹226，所述外侧关节轨迹226具有外侧前后范围LAP。外侧关节轨迹226可以包括沿着外侧间室222近端面214的多个最远点，其在股骨组件回滚期间与股骨外侧髁接触。类似地，内侧间室220可以具有内侧关节轨迹228，所述内侧关节轨迹228具有内侧前后范围MAP，MAP不同于外侧前后范围LAP。内侧关节轨迹228可以包括沿着内侧间室220近端面214的多个最远点，其在股骨组件回滚期间与股骨内侧髁接触。
如图5、6和6A所示，在一个实施例中，外侧间室222可具有前部230和后部232。当投影到胫骨承载组件212横截面上时，前部230可以限定外侧关节轨迹226为名义上的直线231。当投影到胫骨承载组件212横截面上时，后部232可以限定义外侧关节轨迹226为朝向内侧间室220的曲线233。
与此不同的是，当投影到胫骨承载组件212横截面上时，内侧关节轨迹228可以限定名义上的直线235，由内侧间室220定义的内侧关节轨迹228可包括仅具有单一矢状半径R的统一单曲线，如图5C所示。在一些情况中，可以由内侧关节轨迹228限定的名义上的直线与外侧关节轨迹226后部230所限定的名义上的直线基本平行。
为方便起见，本讨论涉及胫骨承载组件212与股骨组件之间沿着关节轨迹226、228的接触的点、轨迹或线。然而，当然应理解，接触的各潜在点或线(即沿着关节轨迹226、228之一的任何点)不是真实的点或线，而是如图8所示的接触区域。这些接触区域可相对更大或更小，这取决于多种因素，如假体材料、施加于胫骨承载组件212与股骨组件之间界面的压力的量，胫骨承载组件212相对于股骨组件的相对形状等。此外，应理解，一些影响接触区域尺寸的因素可在假体使用期间动态变化，如在走路、爬楼梯或蹲伏期间于股骨/胫骨界面处的所施加的压力的量。出于本讨论目的，接触点可作为接触区域几何中心处的点。进而(in turn)，几何中心指所有以下直线的交叉点，所述直线将给定区域分成对各条线等力矩的2个部分。换言之，几何中心可以说是给定区域所有点的均值(即算术平均数)。类似地，线或轨迹是通过并二等分接触延伸区域的接触的中线。
内侧间室220和外侧间室222都可以包括驻留点234及236。驻留点234及236可分别包括沿着内侧关节轨迹228和外侧关节轨迹226的最远点。如下表1所示，内侧间室220可以配置成具有处在从胫骨承载组件212最前点A到胫骨承载组件212最后点P所测量的胫骨承载组件212总前后范围T的约61％-约66％的距离的内侧驻留点234。
如表2所示，外侧间室222可以配置成具有处在从胫骨承载组件212最前点A到最后点P所测量的胫骨承载组件212总前后范围T的约65％-约69％的距离的外侧驻留点236。
如图5所示，后部空槽218经调整尺寸和位置(sized and positioned)以在植入胫骨承载组件212后适合后十字韧带。髁间隆起224可包括关节面214的髁间脊，其可以置于内侧与外侧间室220、222之间。髁间隆起224一般能从后部空槽218到前部缓冲空间219前后延伸。因此，由髁间隆起224限定的髁间脊可以置于内侧与外侧的碟形的内侧和外侧间室220、222之间，并占据其间的可用前后空间。
图5A以冠状面显示通过承载组件的横截面，并阐明内侧间室220和外侧间室222的每一个的内侧-外侧半径R1及R2。根据不同实施例，就内侧和外侧而言，这些半径可以相同或不同。图5A额外阐明远端面215、外围216和髁间隆起224。如图5A所示，可以使外围216成形以紧密配合胫骨托件侧壁(未显示)的对应特征，如从而产生过盈配合。
图5B和5C更详细显示胫骨承载组件212内侧，包括内侧间室220。如图5C所示，胫骨承载组件212可具有约9mm-约13mm的前唇高度，从驻留点234到内侧间室220的最近端点测量所述前唇高度。图5C以沿着矢状平面的横截面显示内侧间室220，并显示内侧间室220可具有单一矢状半径RSM。
图6和6A更详细显示胫骨承载组件212外侧面，包括与图5-5C不同视角(perspective)的外侧间室222。图6显示，外侧间室222可具有前部230和后部232。回忆图5，当投影到胫骨承载组件212横截面上时，前部230能限定外侧关节轨迹226为名义上的直线231。当投影到胫骨承载组件212横截面上时，后部232可以限定外侧关节轨迹226为朝向内侧间室220的曲线233。图6A以横截面显示外侧间室222，并显示外侧间室222可在前部具有第一矢状半径RSL1且在后部具有第二矢状半径RSL2，第一矢状半径RSL1与第二矢状半径RSL2之间的转换由线P指示。
本文所述胫骨承载组件和股骨组件可以作为胫骨承载组件家族和股骨组件家族分别各自可用。胫骨承载组件家族可具有相同设计类别(如成形为十字韧带恢复)且具有不同标准尺寸(如从小尺寸A到最大尺寸J)。类似地，股骨承载组件家族可具有相同设计类别(如成形为与十字韧带保留型胫骨承载组件连接)且具有不同标准尺寸(如从小尺寸1到最大尺寸12)。
图7显示胫骨组件312家族相对于股骨组件314家族的尺寸分级表。更具体地，该尺寸分级表显示股骨组件314家族可以具有至少12种不同标准尺寸1-12。如前所讨论和阐述，各股骨组件可具有相同设计类别且可以包括内侧髁和外侧髁。胫骨组件312家族可以具有至少9种不同标准尺寸A-J。如图7所示，胫骨承载组件313家族可以配置成存在11种标准尺寸且胫骨组件家族的至少9种不同标准尺寸的组合与股骨组件314家族的至少12种不同标准尺寸兼容而一起可操作使用(如促进与天然膝盖类似的所需连接)。图7还阐明胫骨承载组件的11种不同标准尺寸中的9种与胫骨组件的12种标准尺寸中不超过2种相容。根据进一步的实施例，股骨组件314家族的至少12种不同标准尺寸中的10种能与胫骨承载组件313家族的至少9种不同标准尺寸中的8种兼容而一起可操作使用。另外，股骨组件314家族的至少12种不同标准尺寸中的8种能与胫骨承载组件313家族的至少9种不同标准尺寸中的6种兼容而一起可操作使用。根据进一步的实施例，股骨组件家族的至少12种不同标准尺寸中不超过4种能与胫骨承载组件至少12种不同标准尺寸中的2种兼容而一起可操作使用。
此重叠的尺寸分级和提供许多不同兼容尺寸可以有益处，包括提供稳定性增加的股骨组件内侧髁。例如，通过具有胫骨承载组件家族和股骨组件家族，前者可包括至少11种不同标准尺寸且后者可包括至少12种不同标准尺寸，有24种不同的可能的可操作组合，在最坏情况下，伸直的股骨组件与胫骨承载组件之间的内侧一致性能具有1.1:1的一致性比例，超过半数(54％)的胫骨承载组件家族的尺寸与股骨组件家族的尺寸之间的可操作组合可以具有1:1的一致比例。“一致性”(在膝假体背景下也称为“一致”或“一致比例”)指矢状平面中凸的股骨髁与对应的凹的胫骨关节间室之间曲率的类似性。因此，一致性比例可包括内侧胫骨承载间室矢状半径与内侧股骨髁矢状半径之间的类似性比例。
此外，具有重叠的尺寸分级和提供许多不同的兼容尺寸(单独和/或除了使间室成形之外，使用之前讨论的方面进行，以更好符合髁)可适合(provide for)股骨组件内侧髁与胫骨承载组件内侧间室之间增加的接触区域。因此，股骨组件可以具有更高的相对于内侧髁的稳定性。这类接触区域402(内侧间室接触区域)和404(外侧间室接触区域)的示例示于图8，其显示胫骨承载组件412的关节面414在不同屈曲角度接触股骨组件。表3显示来自胫骨承载组件和股骨组件家族的不同尺寸的股骨组件及胫骨承载组件组合可以实现排列，其中在股骨组件0°屈曲，内侧间室总表面积的最少31％能被接触，在股骨组件45°屈曲，内侧间室总表面积的最少13％能被接触。
表3
根据表3所示的实施例，可以配置不同尺寸的股骨租金和胫骨承载组件的组合，使得在股骨组件0°屈曲时，内侧间室总表面积的约31％-约63％与股骨组件内侧髁接触。换言之，可以相对于内侧髁配置内侧间室，在股骨组件0°屈曲时，所述内侧间室总表面积的约31％-约63％与股骨组件内侧髁接触。
额外说明
上面的详细描述包括参考附图，其形成详细描述的部分。附图以阐述方式显示特定实施方案，其中能实践本发明。这些实施方案也在本文称为“实施例”。这类实施例可包括除了所示或所述的那些之外的要素。然而，本发明者也考虑仅提供所示或所述要素的实施例。此外，本发明者还考虑使用所示或所述要素任何组合或排列的实施例(或其一个或多个方面)，关于特定实施例(或其一个或多个方面)或关于本文所示或所述其它实施例(或其一个或多个方面)。
本文档中，使用术语“一(a)”或“一(an)”与专利文献中一样，包括一种或多于一种，独立于任何其它例子或使用“至少一种”或“一种或多种”。本文档中，除非另有说明，术语“或”用于指非排他性或从而“A或B”包括“A但非B”、“B但非A”以及“A和B”。本文档中，术语“包括”和“在其中”用作各术语“包含”及“其中”的简明英语等价物。同样，在以下权利要求中，术语“包括”和“包含”是开放式的，即包括权利要求中该术语后所列那些之外的要素的系统、装置、物品、组合物、配制物或工艺仍视作在该权利要求范围内。此外，在以下权利要求中，术语“第一”、“第二”和“第三”等仅用作标签，不意在将数值要求施加于其对象。
上面的描述意在阐述，而不是限制。例如，上述实施例(或其一个或多个方面)能彼此联用。能使用其它实施例，如通过本领域普通技术人员回顾上面的描述。提供摘要以符合37C.F.R.§1.72(b)，从而使读者能迅速确定技术公开的性质。应理解，其不用于解释或限制权利要求范围或意义。同样，在上面的详细描述中，多种特征能聚集到一起以使公开内容合理化。这不应解释为指未要求权利的公开特征对任何权利要求必要。相反，本发明主题可能不太在于具体公开实施例的所有特征。因此，下列权利要求在此作为实施例或实施方案纳入详细描述，各权利要求自身作为分开的实施例，预计这类实施例能以多种组合或排列彼此联合。本发明范围应参考所附权利要求以及这类权利要求所述等价物的全范围确定。

Claims (21)

1.一种胫骨承载组件，用于在膝盖置换手术中与股骨组件的内侧髁和外侧髁连接，所述胫骨承载组件包括：
远端面；和
与所述远端面相对置的关节面，关节面包括内侧间室和外侧间室，配置成分别连接股骨组件的内侧髁和外侧髁；
所述外侧间室具有外侧关节轨迹，所述外侧关节轨迹具有外侧前后范围，所述外侧关节轨迹包含沿着外侧间室近端面的多个最远点，其在股骨组件回滚期间与外侧髁接触；
内侧间室在构型上不同于外侧间室且具有约9mm-约13mm的前唇高度。
2.如权利要求1所述的胫骨承载组件，其中所述外侧间室具有前部和后部，当投影到胫骨承载组件横截面上时，所述前部限定外侧关节轨迹为名义上的直线，当投影到胫骨承载组件横截面上时，所述后部以朝向内侧间室的曲线限定外侧关节轨迹。
3.如权利要求2所述的胫骨承载组件，其中所述外侧间室在前部中具有第一矢状半径且在后部中具有第二矢状半径。
4.如权利要求1-3中任一项或任何组合所述的胫骨承载组件，其中所述内侧间室具有内侧关节轨迹，所述内侧关节轨迹具有内侧前后范围，所述内侧前后范围不同于外侧前后范围，所述内侧关节轨迹包含沿着内侧间室近端面的多个最远点，其在股骨组件回滚期间与内侧股骨髁接触，其中当投影到承载组件横截面上时，内侧间室限定内侧关节轨迹为名义上的直线，且所述内侧关节轨迹具有单一矢状半径。
5.如权利要求4所述的胫骨承载组件，其中所述内侧间室配置成具有处在从胫骨承载组件最前点到最后点所测量的胫骨承载组件总前后范围的约61％-约66％的距离的内侧驻留点。
6.如权利要求1-4中任一项或任何组合所述的胫骨承载组件，其中所述外侧间室配置成具有处在从胫骨承载组件最前点到最后点所测量的胫骨承载组件总前后范围的约65％-约69％的距离的外侧驻留点。
7.如权利要求1-6中任一项或任何组合所述的胫骨承载组件，其中相对于内侧髁配置所述内侧间室，股骨组件0°屈曲时，所述内侧间室总表面积的约31％-约63％与股骨组件内侧髁接触。
8.如权利要求1-6中任一项或任何组合所述的胫骨承载组件，其中所述内侧间室配置成与内侧髁具有约1:1一致比-约1.1:1一致比，一致比包括内侧间室矢状半径与内侧髁矢状半径之间的类似性之比。
9.一种用于膝关节成形术的系统，所述系统包括：
具有至少12种不同标准尺寸的股骨组件家族，各股骨组件包括内侧髁和外侧髁；和
具有至少11种不同标准尺寸的胫骨承载组件家族，各胫骨承载组件包括：
远端面；和
与远端面相对置的关节面，关节面包括内侧间室和外侧间室，配置成分别连接股骨组件的内侧髁和外侧髁；
配置胫骨承载组件家族，使得胫骨承载组件家族的至少11种不同标准尺寸的24种组合能与股骨组件家族的至少12种不同标准尺寸及胫骨组件家族的至少9种不同标准尺寸兼容而一起可操作使用。
10.如权利要求9所述的系统，其中配置所述股骨组件家族和胫骨承载组件家族，使得股骨组件0°屈曲时，内侧间室总表面积的约31％-约63％与股骨组件内侧髁接触。
11.如权利要求9所述的系统，其中所述内侧间室配置成与内侧髁具有约1:1一致比-约1.1:1一致比，一致比包括内侧间室矢状半径与内侧髁矢状半径之间的类似性之比。
12.如权利要求9-11中任一项或任何组合所述的系统，其中所述内侧间室配置成具有处在从胫骨承载组件最前点到最后点所测量的胫骨承载组件总前后范围的61％-约66％的距离的内侧驻留点。
13.如权利要求9-12中任一项或任何组合所述的系统，其中所述股骨组件家族的至少12种不同标准尺寸中的10种能与胫骨承载组件家族的至少11种不同标准尺寸中的10种兼容而一起可操作使用。
14.如权利要求9-13中任一项或任何组合所述的系统，其中所述股骨组件家族的至少12种不同标准尺寸中的8种能与胫骨承载组件家族的至少11种不同标准尺寸中的6种兼容而一起可操作使用。
15.如权利要求9-14中任一项或任何组合所述的系统，其中所述胫骨承载组件家族的至少11种不同标准尺寸中的9种能和股骨组件家族的至少12种不同标准尺寸中不超过2种兼容，股骨组件家族至少12种不同标准尺寸中不超过4种能与胫骨承载组件家族的至少11种不同标准尺寸中的2种兼容而一起可操作使用。
16.如权利要求9-15中任一项或任何组合所述的系统，其中所述内侧间室具有约9mm-约13mm的前唇高度。
17.如权利要求9-16中任一项或任何组合所述的系统，其中所述内侧间室具有内侧关节轨迹，所述内侧关节轨迹具有内侧前后范围，所述内侧前后范围不同于外侧前后范围，内侧关节轨迹包含沿着内侧间室近端面的多个最远点，其在股骨组件回滚期间与内侧股骨髁接触，其中当投影到承载组件横截面上时，内侧间室限定内侧关节轨迹为名义上的直线且内侧关节轨迹具有单一矢状半径。
18.一种胫骨承载组件，用于在膝盖置换手术中与股骨组件内侧髁和外侧髁连接，所述胫骨承载组件包括：
远端面；和
与远端面相对置的关节面，关节面包括内侧间室和外侧间室，配置成分别连接股骨组件的内侧髁和外侧髁；
外侧间室配置成具有处在为从胫骨承载组件最前点到最后点所测量的胫骨承载组件总前后范围的约65％-约69％的距离的外侧驻留点。
19.如权利要求18所述的胫骨承载组件，其中所述内侧间室的构型不同于外侧间室且具有约9mm-约13mm的前唇高度。
20.如权利要求18-19中任一项或任何组合所述的胫骨承载组件，其中所述外侧间室具有外侧关节轨迹，所述外侧关节轨迹具有外侧前后范围，外侧关节轨迹包含沿着外侧间室近端面的多个最远点，其在股骨组件回滚期间与外侧髁接触，其中外侧间室具有前部和后部，当投影到胫骨承载组件横截面上时，前部定义外侧关节轨迹为名义上的直线，当投影到胫骨承载组件横截面上时，后部以朝向内侧间室的曲线限定外侧关节轨迹。
21.如权利要求20所述的胫骨承载组件，其中所述外侧间室在前部中具有第一矢状半径且在后部中具有第二矢状半径。
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