CN105208944A - 通用髋臼引导件和相关联的器械 - Google Patents

通用髋臼引导件和相关联的器械 Download PDF

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CN105208944A
CN105208944A CN201480027016.XA CN201480027016A CN105208944A CN 105208944 A CN105208944 A CN 105208944A CN 201480027016 A CN201480027016 A CN 201480027016A CN 105208944 A CN105208944 A CN 105208944A
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CN105208944B (zh
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C·伊阿什
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Special Single Liability Co That Is Constructed With Of Bai Ou Meter
Biomet Manufacturing LLC
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    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8897—Guide wires or guide pins
    • A—HUMAN NECESSITIES
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    • 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
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    • A61F2/4603—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4609—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof of acetabular cups
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/1662—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1664—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body for the hip
    • A61B17/1666—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body for the hip for the acetabulum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
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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
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2002/4687—Mechanical guides for implantation instruments

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Abstract

提供了一种整形手术装置，包括可用于制备患者的髋臼以接纳髋臼植入物的患者特异性髋臼引导件。该髋臼引导件具有本体，该本体具有构造用于匹配特定患者的臀部关节的髋臼的外部三维表面，该髋臼是利用患者臀部关节的数据设计的。髋臼引导件还可以包括周面环形边缘。

Description

通用髋臼引导件和相关联的器械
技术领域
本教导涉及髋臼引导件，具体涉及患者特异性引导件和各种相关联的器械。
背景技术
在解剖结构例如人类或其它动物解剖结构中，一部分可能受损。可以将假体件安放在解剖结构中以替换受损的部位。本教导针对用于将髋臼植入物植入患者的髋臼以进行臀部关节置换的患者特异性髋臼引导件和相关联的器械。患者特异性髋臼引导件可包括允许使用多个使用者选择的入路中的一个执行手术的多个部分。
发明内容
本教导提供一般用于制备患者的髋臼以沿对齐轴线接纳髋臼植入物例如髋臼杯的各种器械和方法。在术前规划中利用患者相关解剖结构的三维重构可以确定对齐轴线并可确定和设计各种患者特异性引导件和其它相关联的器械。对于髋臼手术，重构可包括骨盆或部分骨盆，包括骨盆的髋臼和髋臼周围区域。三维重构可基于治疗对象的图像数据，例如利用商业上可获得的图像软件制备的磁共振图像数据(MRI)、计算机断层扫描(CT)图像数据、超声波和/或X射线扫描。
本教导提供例如患者特异性髋臼引导件，该髋臼引导件可用于制备患者的髋臼以接纳髋臼植入物例如髋臼杯。髋臼引导件可具有包括周面环形边缘和外部三维表面的拱形本体，该拱形本体基于在针对患者的术前规划期间获得的患者髋臼的三维图像、构造用于匹配特定患者的髋臼。患者特异性对准引导件可以永久附接和/或可去除地定位到周面边缘。患者特异性对准引导件可具有限定患者特异性对齐轴线的纵向孔口，其中对齐取向构造用于在患者的术前阶段为患者引导髋臼植入物。对准引导件具有构造用于与患者髋臼的髋臼周围表面和/或髋臼边缘表面的相应部分配合的患者特异性下表面。
在一些实施例中，髋臼引导件可包括多个间隔开的对准凸缘(也称为指部或延伸部)。各个对准凸缘可以从髋臼引导件的周面边缘延伸出并附接到髋臼引导件的周面边缘。各个对准凸缘具有构造用于与患者髋臼的髋臼边缘的选定表面配合的患者特异性下表面。
本教导还提供了一种臀部关节置换的方法。该方法包括将患者特异性髋臼引导件插入患者髋臼。髋臼引导件的拱形本体的患者特异性下表面与髋臼的相应表面的凹面(negative)基本配合。引导件可包括从髋臼引导件的周面边缘延伸出并在髋臼的髋臼边缘的一部分上延伸的至少一个患者特异性对准凸缘。
所述引导件和方法包括穿过患者特异性对准引导件的孔口将对齐销钉插入患者骨骼。患者特异性对准引导件可以可去除地附接到髋臼引导件的周面边缘。患者特异性对准引导件在术前构造用于限定用于插入髋臼植入物的患者特异性对齐取向。所述方法包括去除髋臼引导件而不去除对齐销钉，并沿大体平行于对齐销钉的取向插入髋臼植入物。但平行对齐可包括来自使用者或制造偏差的误差和/或使用者的选择性不平行对齐。
本教导的适用性的其它领域从下文提供的描述中将变得显然。应该理解，描述和特定示例仅用于说明而不用于限制本教导的范围。
附图说明
从详细描述和附图可以更全面地理解本教导，其中：
图1A是根据各个实施例的引导件的第一视角的平面图；
图1B是根据各个实施例的图1A的引导件的第二视角的平面图；
图1C是图1A的引导件的侧视图；
图2是根据各个实施例的正被安放的图1A的引导件的局部环境平面图；
图3A是根据各个实施例的图1A的引导件的第一视角的局部环境平面图；
图3B是根据各个实施例的图1A的引导件的第二视角的局部环境平面图；
图4是根据各个实施例的销钉引导件；
图5A和5B是利用引导件和器械安放的对齐销钉的局部环境平面图；
图6-8是根据各个实施例利用引导件和具有器械引导件的器械安放的对齐销钉的局部环境平面图；以及
图9是安放在骨盆中的假体的局部环境平面图。
在贯穿附图的几个视图中相应的附图标记标示相应的部件。
具体实施方式
下面的描述仅仅是实际上的示例，绝不用于限制本教导、应用或使用。
本教导总体上提供用于整形手术例如用于臀部的关节替换或修整手术的患者特异性髋臼对齐引导件、插入件和/或其它相关联的器械。患者特异性对齐引导件和相关联的器械可基于特定患者的医学扫描利用计算机辅助成像方法与常规的或与患者特异性植入构件一起使用。
如引用在此作为参考的2012年1月1日授权的美国专利No.8,092,465和2012年2月21日提交的美国专利申请出版物No.2012/0226283所述，在术前规划阶段，可以在包括医生办公室的机构获得患者相关解剖结构的成像数据。成像数据可包括例如骨盆、臀部、膝盖、脚踝或其它关节或患者解剖结构的相关部位的详细扫描。可利用MRI、CT、X-Ray、超声波或任何其它的成像系统获得成像数据。所获得的成像数据可用于构建关节或患者的解剖结构的其它部位的三维计算机成像，并用于准备可包括骨骼或关节制备的最初的术前规划，例如为切除、铣削、铰孔、扩孔以及植入物选择和安装做规划，设计用于外科手术的患者特异性引导件、模板、工具和对齐草案。另外，在外科手术之前可制备患者的关节和相关联的骨骼的物理模型，用于引导件和植入物的可视化和试验。
通过从各个供应商或开发者例如加拿大蒙特利尔的ObjectResearchSystems或ORS处可购买的各种计算机辅助制图(CAD)程序、应用和/或软件可提供用于获得相关患者的解剖结构的三维计算机图像的计算机模型设计。计算机模型设计程序或其它应用可构造和用于规划术前外科手术规划，包括规划各个骨骼制备手术，以选择或设计/修改植入物以及设计患者特异性引导件和工具。患者特异性引导件和工具可包括患者特异性假体构件以及患者特异性工具，包括铰孔、扩孔、铣削、钻孔或切割工具、对齐引导件、模板和其它患者特异性器械。
术前规划可以以计算机文件形式或者包括三维图形文件或数字数据集的任何其它计算机或数字表示的形式存储在任何计算机存储介质中。与交互式软件或其它应用相关联的数字形式的术前规划可以经由硬件介质、基于网络或移动或云服务、或可以利用蜂窝网络的便携式设备来执行。该规划可经由各种系统或媒介提供给外科医生或其他开业医生进行审核。利用交互式软件或应用，外科医生可以审核所述规划，以及相对于解剖结构的图像调整各个植入构件的图像的位置。外科医生可以修改所述规划并将修改后的规划连同建议或改变发送给制造商。可以重复该交互式审核过程，直到将最终经核准的规划发送给生产设备以制备真实的实物构件。在各个实施例中，实物的和数字的患者特异性骨骼模型、引导件和器械可以在术前提供给外科医生进行试验和标记。
在外科医生核准外科手术规划后，可以根据术前外科手术规划利用CAD程序或其它三维模型设计软件例如加拿大的蒙特利尔的ObjectResearchSystems或ORS提供的软件来设计患者特异性植入物和相关工具，包括例如用于特定患者的关节或其它解剖结构部位的外科手术制备的对齐引导件、切割/铣削/铰孔/扩孔或其它工具。可通过各种光固化成型方法、选择性激光烧结、熔融沉积成型、或其它快速成形方法、和/或计算机控制的机加工来制造患者特异性引导件和其它器械。在一些实施例中，可生成用于加工患者特异性引导件和/或植入物的工具路径的计算机指令并存储在工具路径数据文件中。该工具路径数据可以作为输入提供给CNC铣削或其它自动机加工系统，可以根据用途由聚合物、陶瓷、金属或其它合适的材料机加工出所述工具和植入物并消毒。消毒过的工具和植入物可以运送给外科医生或医学机构以在外科手术中使用。
患者特异性植入物、引导件、模板、工具或它们的一部分在文中定义为通过用于特定患者的术前规划、根据按患者的术前图像扫描重新构建的特定患者的解剖结构的三维图像而构建。患者特异性构件构建成紧密地贴合并与患者的解剖结构的表面基本配合或匹配。配合或匹配一般例如患者解剖结构的对应表面部分的凹模、凹面、或相反、或镜面。根据特定的手术、植入物和工具运用，解剖结构表面可包括具有或不具有相关软组织例如关节软骨的骨骼表面。不需要反映例如不影响引导件安放的患者关节表面的极小的不平整部。
如上所述，患者特异性对齐引导件和植入物一般构造用于匹配特定患者的解剖结构并仅安装/对准到特定患者的相应表面的一个位置，因为各个患者独特的解剖结构特征可用作界标，并可引导对齐引导件或植入物仅安放在一个位置而不需要术中图像导航、患者标记或其它术中引导。一般利用基于患者3D解剖结构图像的计算机模型设计来构造和制造患者特异性对齐引导件，如上所述，该对齐引导件具有通过上文讨论的计算机方法制成的与患者骨骼表面(具有或不具有软骨或其它软组织)的三维图像/模型的相应表面贴合接触和匹配的接合面。
通常，患者特异性引导件具有直接接触特定患者的解剖结构的选定区域的选定部位的外表面。例如，患者特异性引导件在适当定位时可包括直接接触患者解剖结构(例如特定患者的髋臼)的约80％的外表面(例如髋臼引导件的外部拱起表面)，包括约90％的接触和约98％的接触。因此，与患者匹配的引导件的外表面可与解剖结构的选定部位基本配合。但应该理解，患者特异性引导件的某些外部部位与患者可以不具有实质接触，而其它部位设计成即使在其它部位(某些外部部位)不接触患者时也确保接触。因此，与患者匹配的引导件可以具有与患者基本匹配并具有或可获得与患者选定数量的接触的部位。
患者特异性对齐引导件可包括一个或多个定制的引导形式，例如引导孔口或插套管的引导柱体或插套管的引导延伸部或插孔，根据外科医生核准的术前规划，所述引导形式可用于支撑或引导其它器械例如钻孔引导件、铰刀、切刀、切割引导件和切割垫块，或用于插入销钉或其它紧固件。患者特异性对齐引导件可用于微创手术，也可用于具有多个微创切口的手术。在2012年1月10日授权的美国专利No.8,092,465、2011年12月6日授权的美国专利No.8,070,752、2012年3月13日授权的美国专利No.8,133,234、2009年1月22日公开的美国公报No.2009/0024131、2008年5月15日公开的美国公报No.2008/0114370、2012年10月30日授权的美国专利No.8,298,237、2011年11月15日公开的美国公报No.2011/0224674、2011年7月28日公开的美国公报No.2011/0184419、和2012年9月6日公开的美国公报No.2012/0226283中公开了各种对齐引导件和术前规划手术，所有这些专利和申请都引用在此作为参考。
参考图1A和1B，示出髋臼引导件100。髋臼引导件100可包括与引用在此作为参考的2012年12月11日提交的美国专利申请13/711,306中描述的髋臼引导件类似的各个部分。如上所述，髋臼引导件100可包括基本匹配患者的解剖结构的外表面102。通常，外表面102可形成为与患者的解剖结构例如髋臼配合，以接合髋臼从而相对于治疗对象的髋臼以单个选定的位置和取向对准或定位髋臼引导件100。可基于术前规划期间获得的治疗对象的图像数据设计和形成外表面102。除了外表面，一个或多个对准凸缘110可形成为从引导件100的上部或周面边缘112伸出。对准凸缘110可以接合患者的髋臼的髋臼边缘，以帮助相对于患者对准引导件100。另外，对准凸缘110可帮助相对于髋臼引导引导件100，以确保引导件100适当地安放在髋臼中用于执行手术。
另外，引导件100可包括例如引用在此作为参考的2012年12月11日提交的美国专利申请13/711,306中公开的各个附加的部分。简言之，各个附加的部分可包括穿过引导件100的表面102形成的通道或窗口114，以帮助观察解剖结构的部分例如髋臼。除了窗口114，还可限定一个或多个固定孔口116，以帮助相对于治疗对象固定引导件100。例如，螺钉可穿过通道116以帮助相对于治疗对象固定引导件100。另外，可穿过对准凸缘110、边缘112或引导件的其它部分设置各个通道，以帮助相对于治疗对象固定引导件100。销钉、平头钉、螺钉和其它元件可以穿过引导件的选定部分，以将引导件100固定到治疗对象。但应该理解，各个固定元件不是必须帮助相对于患者保持或固定引导件100。如文中进一步所述，引导件100相对于患者对准可提供引导件100的适当的定位和固定，以定位对齐销钉。
引导件100还包括内表面120，窗口114和通道116也可穿过所述内表面形成。另外，一个或多个柱体或定位元件130和140可以从引导件100的内表面伸出。定位柱体130可以是主柱体或中央定位柱体140的扩增柱体。通常，主柱体140可以从中央延伸或沿引导件100的中央轴线延伸，并限定引导件100的中央对齐轴线A。通常，中央主柱体140可以限定在规划过程中相对于治疗对象或患者已经预定的对齐轴线A。通常，对齐轴线A如文中进一步所讨论可用于相对于用于定位对齐销钉150的髋臼或骨盆定位或确保销钉引导件的位置，如文中进一步所讨论。对齐销钉可以是钻孔销钉、穿刺销钉、或适当的细长元件。对齐销钉150可以沿辅助轴线A1形成或定位，该辅助轴线形成为基本平行于穿过中央柱体140的轴线A。两个轴线A1和A确保对齐销钉150以用于对齐各个器械和假体的预定的取向定位在骨盆内，如文中进一步所讨论。对齐销钉150穿过可移动的、可铰接的对齐或销钉引导件160定位。销钉引导件160可由选定的材料例如金属或金属合金形成，以安装在中央柱体140上。引导件100的剩余部分如上所述基本可由作为容易成形的材料的聚合物形成。但是由于对齐销钉150相对于销钉引导件160的定位，销钉引导件160可抵抗磨损和变形。
销钉引导件160可经由形成在臂轴套162中的中央引导孔口相对于引导件100定位。臂轴套162可以接合中央柱体140并大体沿箭头164的方向绕中央柱体140转动。销钉引导件160大体沿箭头164的方向的移动允许穿过本体168形成的销钉孔口166的移动。对齐销钉150可穿过孔口166。本体168可连接到第一臂部170，该第一臂部可与第二臂部172协作。第一臂部170可大体沿箭头174的方向相对于第二臂部172关节式动作或平移。例如，第一臂部170可以至少部分接纳在第二臂部172中并可相对于第二臂部172移动。因此，本体168可相对于中央柱体140转动并也可相对于中央柱体140沿纵向平移。通常，本体168的移动也可以沿着或相对于引导件100的边缘112。
根据各个实施例，销钉引导件160可相对于中央孔口柱体140定位，使得引导轴套162沿轴线A对齐。然后第一臂件170和第二臂件172可以在由边缘112的一部分限定的第一引导表面180上延伸。如文中进一步所讨论，第二引导表面182也可以形成在边缘112上。然而，销钉引导件160可以相对于中央柱体140转动并被引导或靠置在第一引导表面180上。另外，第一或第二引导臂170、172可以平移，以改变引导件本体168在横向相对于中央柱体140的距离。
如文中进一步所讨论，在术前规划期间可以限定对齐轴线A，以帮助对齐各个器械和植入物部分。因此，也可以相对于轴线A限定中央柱体140的位置。销钉引导件160可形成为相对于轴线A具有一关系，使得轴线A1基本平行于引导件100的轴线A或与引导件100的轴线A成选定的角度。当对齐销钉150穿过销钉引导件160的引导孔口166时，对齐销钉150也沿轴线A1定位到患者的解剖结构中。
在选定的手术中，销钉引导件160可以沿第一引导表面180和/或第二引导表面182相对于引导件100定位。在各个实施例中，第一引导表面180可设置用于在前侧入路以定位对齐销钉150并进一步执行髋臼的植入手术。第二引导表面182可设置用于在后外侧入路以用于相同的目的，例如定位对齐销钉150和/或执行髋臼的手术。因此，引导件100可设置用于执行前侧和后外侧手术。销钉引导件160对于两种入路可以是相同的，其中带有穿过其中的孔口166的引导件本体168形成用于针对任一入路相对于引导件100定位。但孔口166也可设置用于针对前侧入路或后外侧入路具有不同的选定轴线A1。由于与引导表面180或182的相互作用或者由于销钉引导件160绕中央柱体140的转动，会导致不同的角度。
继续参考图1A-1C并另外参考图2A-3B，引导件100可以相对于治疗对象的骨盆200定位，例如定位在髋臼202中。引导件100还可以相对于髋臼接合髋臼边缘204，以帮助相对于髋臼202定位和对准引导件100。引导件100一旦相对于髋臼202被定位就可用于将对齐销钉150安放在骨盆中，以引导手术。
引导件100可利用包括柄部222和引导接合部224的插入件220插入。引导接合部224可以单独设置或与柄部222设置成一体的单个部件。然而，引导接合部224可以包括主体226，该主体可限定用于接纳和接合中央柱体140的内部孔口。指部或腿部228和230可横向于柄部222延伸以接合第二柱体130。两个腿部228、230可基本平行地形成以接合第二柱体130。因此，插入件220可以接合引导件100以固定地保持引导件100，同时定位在骨盆200的髋臼202中。
插入件220可以接合引导件100，以将引导件定位在患者的骨盆200中。当插入件220接合髋臼引导件100以相对于插入件220不可旋转地固定髋臼引导件时，插入件220可用于确保引导件100相对于解剖结构适当的定位和取向。例如，引导件100可以转动，以确保引导件相对于治疗对象适当的对准和接合。因此，一旦插入件220接合引导件100，引导件就可以相对于骨盆200转动、定位和移动、或以其它方式适当地移动，以确保适当地对准到骨盆200。
一旦定位在髋臼202中，引导件100可用于将对齐销钉150定位到骨盆200中。可以理解，患者的解剖结构可限定各个解剖结构平面，包括如图3B所示的轴面(AP)、矢面(SP)和前侧骨盆面(APP)。可以穿过包括引导件本体168的销钉引导件160定位对齐销钉150，以将对齐销钉150定位在骨盆200中。
如上文所述，销钉引导件160可沿各个表面180、182移动，以将对齐引导件本体168定位在选定位置。外科医生导致的对齐本体168的移动可帮助确保对齐销钉150定位在解剖结构的适当结实并足够致密的部位中以保持对齐销钉150用于手术。虽然对齐销钉150沿大体平行于引导件100的主柱体140的轴线A的轴线A1定位，但销钉150可相对于髋臼202定位在多个位置，以确保相对于髋臼202适当固定。因此，一旦确定入路并开始，可相对于第一引导表面180定位销钉引导件160以执行前侧入路和/或相对于引导表面182定位销钉引导件160以执行后外侧入路。可相对于引导件100的中央柱体140基本保持对齐销钉150的角度，但可相对于中央柱体140设置引导件本体168的平移位置，以定位引导件100。
如上文所述，继续参考图3A和3B并进一步参考图1A-2，一旦引导件100被定位于患者的髋臼202中并在患者的髋臼202中恢复原状，对齐销钉150可穿过销钉引导件160进入骨盆200。但是，首先本体168可通过借助于轴套162绕主柱体140转动而相对于引导件100移动，并由于第一臂部170的关节式连接而离中央柱体140一定距离地被关节式连接。因此，使用者可以大体沿箭头164的方向使本体168绕中央柱体转动，以相对于髋臼202将本体168定位在选定的位置。例如，第一臂部170、第二臂部172或这两个臂部可以沿相应的表面180和182移动，以将引导件本体168定位用于前侧或后外侧手术。此外，可基于使用者观察到的患者的解剖结构对本体168的定位进行微调。虽然手术可以预先规划，但使用者可基于对解剖结构的直接肉眼观察来确定安放或定位对齐销钉150的具体位置。另外，外科医生在手术中可改变规划，这可能要求或允许相对于对齐引导件100的中央柱体140改变对齐销钉150的位置。此外，在手术过程中可以选择将对齐销钉150定位在距中央柱体140一定的距离处。
外科医生或使用者可以确定在术中执行前侧或后外侧手术。因此，一旦外科医生开始手术例如给病人制作初始切口，外科医生可确定是否从前侧或后外侧入路完成手术。因此，由于本体168沿轴线A1与中央柱体140的轴线A对齐，单个引导件100可形成用于允许基于前侧或后外侧入路定位对齐销钉150。
如图3A所示，引导轴套162定位在其上的中央柱体140的轴线A允许本体168的轴线A1、因此允许对齐销钉150的轴线与中央轴线A对齐。由此，本体168的位置可定位在绕中央柱体140的任何地点，同时保持中央柱体140的轴线A和本体168的轴线A1的平行或其它选定的取向。可以理解，本体的轴线A1不需要平行于中央柱体140的轴线A。例如，本体168的轴线A1可规划成相对于中央柱体140的轴线A成一角度。可基于对齐销钉150的角度位置实现对植入物、铰刀和其它工具相对于对齐销钉150的定位的选择。
一旦本体168通过使用者以选定的取向定位，销钉150可被驱动进入骨盆。通常，销钉150可定位成靠近髋臼202的边缘204。销钉150可利用任何合适的机构例如钻孔电机250移动到解剖结构中。钻孔电机250可以是适当的钻孔电机例如外科手术领域公知的钻孔电机。钻孔电机可包括卡盘252，以接合并驱动对齐销钉150穿过本体168的孔口166进入解剖结构。
一旦销钉150定位在骨盆200中，可从销钉150去除对齐引导件100。销钉引导件160可以沿销钉150的长度移动，以将销钉引导件160从销钉150和患者去除。当对齐引导件100不直接与销钉150连接时，对齐引导件100可以沿任何选定的方向去除。也就是说，对齐引导件100经由销钉引导件160与销钉150互相连接。但可以理解，销钉引导件160可以与对齐引导件100的剩余部分形成组件，例如在中央柱体140处形成枢轴，该枢轴形成销钉引导件160的轴套162。
除了如上所述的单个本体168，如图4所示，双本体销钉引导件160’可设有单个第一臂部170’。因此，本体可包括第一本体168a和第二本体168b。两个本体可包括穿过其中的孔口166a和166b。各个孔口166a和166b可形成为基本平行于中央柱体140的中央轴线A。然而，包括分开的孔口166a和166b的双本体168a和168b可用于在手术中相对于骨盆200的解剖结构引导彼此处于固定的和已知的关系的两个对齐销钉。因此可以理解，可相对于解剖结构设置如图5B所示的第一对齐销钉150和第二对齐销钉151。销钉引导件160’可包括与上文所述的销钉引导件160类似的其它部分。例如，第一臂部170’可以相对于第二臂部172’和中央轴套162’关节式连接。中央轴套162’可包括可安装在中央柱体140上以允许销钉引导件160’相对于对齐引导件100转动的中央孔口或盲孔163。
继续参考图1-4并附加参考图5A-6，一旦去除对齐引导件100，对齐销钉150和/或对齐销钉151可以定位并保持在骨盆200的解剖结构中。然后，器械例如铰刀或插入把手300可以相对于对齐销钉150定位，以执行手术的更多部分例如给髋臼202铰孔和/或将髋臼植入物400(图9)定位在已铰孔或已制备的髋臼202中。
对齐销钉150可为器械300提供直接对齐，或者在替换方案中，一个或多个第二对齐销钉310可相对于对齐销钉150定位，以提供器械300的直接对齐。第二对齐销钉310可以直接连接到对齐销钉150，或经由第二引导件320与对齐销钉150互相连接并形成为适当的细长元件。第二引导件320可包括穿过销钉150的通孔330。第二引导件320还可以包括第二对齐销钉310可以定位在其中的第二通孔或盲孔340。第二对齐销钉310可以沿轴线B定位，轴线B预先规划用于沿轴线B’对齐器械300。但应该理解，如果对齐销钉150的轴线A1也可以是用于器械300的对齐轴线，则仅对于对齐销钉150不需要提供用于器械300的直接对齐引导的情形提供第二对齐销钉310。
器械300可以与第二对齐销钉310和/或对齐销钉150目视对齐，以执行手术的各个部分，例如铰孔和/或安放髋臼假体。除了器械300与对齐销钉310目视对齐或作为替代，如图6所示，也可提供物理对齐引导件360。物理对齐引导件360可包括例如经由附接套圈362与器械300物理的且基本刚性的附接。对齐引导件360还可以包括用于接合对齐销钉310的凹槽和/或台肩或其它接合部分364。因此可以在器械300和对齐销钉310之间提供物理连接或接触，以确保器械300与对齐销钉310适当的对齐。
接合台肩364可设置成基本敞开，以允许器械300相对于对齐销钉310移动。器械对齐引导件360不完全围绕对齐销钉310的至少一部分。也就是说，可以沿对齐销钉310的长度的轴向之外的方向拉开器械对齐引导件360。
但根据如图7所示的各个实施例，可设置在对齐套圈362处接合器械300的器械对齐引导件380。对齐引导件380可包括具有空心中央孔口386的细长筒体384。空心中央孔口386可围绕第二对齐销钉310。因此，对齐引导件380一般可通过轴向移动从对齐销钉310去除。对齐销钉310在所有侧向保持在对齐引导件380中。
内部孔口386的内径可相对于第二对齐销钉310的外径或尺寸设定为选定的尺寸。例如，孔口386的内径可以基本等于第二对齐销钉310的外径。因此，一旦对齐引导件380与第二对齐销钉310接触或互相连接，可以提供对齐引导件386相对于销钉310非常小的移动。因此，器械300可以相对于对齐销钉310基本保持刚性。
作为替代方案，内部孔口386可以包括比对齐销钉310的外径大一些的内径。例如，孔口386的内径可以比对齐销钉310的外径大10％、20％、50％、或选定的量。作为一个示例，孔口386的内径可以比对齐销钉310的外径大约1毫米(mm)至约10mm、包括约2mm至约5mm、还包括约3mm。
如果孔口386的内径大于对齐销钉310的外径，则对齐引导件380可相对于对齐销钉310在限定的量内横向移动。但横向或侧向移动受到引导件380的内径的限制。因此，从销钉310完全去除被限定为引导件380的轴向运动。当对齐引导件380可以相对于对齐销钉310横向移动时，器械300也可以相对于对齐销钉310移动。器械300相对于对齐销钉310的移动可允许使用者选择改变严格的预先规划的手术。因此，使用者可以在术中确定器械300相对于髋臼202的与对齐销钉150和/或对齐销钉310的预先选定和规划的取向有较小改变的选定的或适当的对齐。
根据各个实施例，在图8中示出对齐引导件390。对齐引导件390可以与对齐引导件380类似，只是384处的筒体可包括一个或多个环形件392而不是一个细长的筒体。各个环形件392也可限定与对齐销钉310的外径在尺寸上有关系的内径394。内径394相对于对齐销钉310的外径的关系可以类似于具有孔口内径386的筒体384相对于对齐销钉310的外径的关系。因此，在这里不提供对其的详细讨论。然而，环形件可以提供有限的横向移动同时将销钉310保持在环形件内。引导件390从销钉310完全去除可以限定于引导件390相对于销钉310的轴向移动。
如上所述，对齐引导件390可以经由附接套圈392与器械300互相连接。因此，根据各个实施例，对齐引导件可以设置用于与对齐销钉310和/或150、151互相连接或协作，以允许在物理上确定器械300相对于各销钉的对齐。
参考图1A-8并附加参考图9，器械300可用于铰孔和/或安放髋臼假体400。假体400可以定位在骨盆200的已制备的髋臼202中。髋臼假体400可以利用器械300通过与对齐销钉150和/或151和/或310对齐而定位。因此，如上所述，髋臼假体400可以沿中央柱体140的轴线或平行于中央柱体140的轴线A而定位。但应该理解，由于销钉引导件160相对于中央柱体140的定位、第二引导件320相对于对齐销钉150和/或151的定位、和器械经由引导件360、380和/或390相对于对齐销钉310和/或150、151的定位，髋臼假体400可以相对于轴线A以任何适当的和预先选定的取向定位。然而，对齐引导件100可以设计和制造成在髋臼202和/或边缘240中与患者的解剖结构相互作用以制备髋臼202，以针对特定患者实现髋臼假体400相对于骨盆200的预定取向。
可以以各种组合并基于外科医生偏好或患者和术前或术中环境使用各种患者特异性引导件、第二引导件、铰刀、引导件把手、插入件、撞击器、支撑装置、电子定位器和其它器械，以制备髋臼并沿术前确定的对齐取向引导和植入髋臼植入物。在这方面，不同实施方式的提供冗余功能的工具和器械可以以工具箱形式或根据外科医生的需求提供给外科医生。
例如，在文中描述的方法的范围内可以以各种组合提供和使用上文描述的适配器和其它器械。
上述讨论仅公开和描述了本教导的示例性方案。此外，在文中明确地设想了各个实施例之间的特点、元件和/或功能的混合和匹配，所以本领域普通技术人员可以从公开内容中认识到一个实施例的特点、元件和/或功能可以适当地结合到另一实施例，除非上文有相反的描述。此外，可以对本教导进行很多修改以适应特定的部位或材料而不会脱离本教导的实质范围。本领域技术人员从这些讨论以及从附图和权利要求中可以容易地认识到，可以对其进行各种改变、修改和变型而不会脱离下面的权利要求中限定的本教导的精神和范围。

Claims (29)

1.一种用于在髋臼附近安放对齐销钉的髋臼引导系统，包括：
髋臼引导件，包括：
所述髋臼引导件的外表面，所述外表面构造成具有用于基本接合特定患者的髋臼的几何形状，和
从所述髋臼引导件的内表面延伸出的中央柱体；和
销钉引导件，包括：
引导件轴套，其可接合到所述中央柱体并相对于所述中央柱体可转动，和
引导件本体，其从所述引导件轴套延伸出、可操作以相对于所述引导件轴套移动；
其中所述引导件本体限定孔口，以允许所述对齐销钉穿过引导件的孔口并接合所述髋臼附近的区域。
2.根据权利要求1所述的髋臼引导系统，其中，所述销钉引导件还包括：
直接从引导件本体延伸出的第一臂；和
直接从引导件轴套延伸出的第二臂。
3.根据权利要求1所述的髋臼引导系统，其中，所述第一臂构造成相对于所述第二臂沿纵向关节式动作，以使所述引导件本体从所述中央柱体移动选定的距离。
4.根据权利要求1所述的髋臼引导系统，其中，由所述孔口限定的销钉轴线平行于由所述中央柱体限定的引导件轴线。
5.根据权利要求1所述的髋臼引导系统，其中，所述引导件本体包括限定第一孔口的第一引导件本体和限定第二孔口的第二引导件本体。
6.根据权利要求5所述的髋臼引导系统，其中，所述第一孔口和所述第二孔口平行；
其中，所述第一引导件本体和所述第二引导件本体相对于彼此被固定。
7.根据权利要求1所述的髋臼引导系统，还包括：
配置成相对于所述中央柱体穿过所述孔口的对齐销钉。
8.根据权利要求7所述的髋臼引导系统，还包括：
限定器械引导件孔口的器械引导件，所述器械引导件孔口具有大于所述对齐销钉的外径的内径。
9.一种用于在髋臼附近安放对齐销钉的髋臼引导系统，包括：
对齐引导件，其具有被构造用于匹配特定患者的外表面；
中央柱体，当所述外表面定位在特定患者的解剖结构中时，所述中央柱体沿引导件轴线从所述对齐引导件的内表面延伸；
上边缘，其至少包括第一支撑部和第二支撑部；
销钉引导件，其具有：
轴套，所述轴套配置用于与所述中央柱体相互作用以允许所述轴套绕所述中央柱体转动，
从所述轴套延伸出的引导件本体，
直接连接到所述引导件本体的第一臂，和
直接连接到所述轴套的第二臂，
其中，所述第一臂相对于所述第二臂可移动；
其中，所述引导件本体构造成相对于所述对齐引导件的中央柱体可移动；
其中，所述引导件本体限定中央孔口，对齐销钉构造成穿过所述中央孔口。
10.根据权利要求9所述的系统，其中，所述第一臂至少部分地接纳在所述第二臂中。
11.根据权利要求9所述的系统，其中，所述第一臂沿所述第二臂移动，以改变所述引导件本体与所述轴套的距离。
12.根据权利要求11所述的系统，其中，所述轴套限定接纳所述中央柱体的至少一部分的盲孔。
13.根据权利要求12所述的系统，其中，由所述中央柱体限定的所述引导件轴线平行于由所述引导件本体中的所述孔口限定的销钉轴线；
其中，所述对齐销钉构造成与所述销钉轴线对齐。
14.根据权利要求12所述的系统，其中，所述轴套绕所述中央柱体转动，所述引导件本体至少由于所述轴套的转动而绕所述中央柱体转动。
15.根据权利要求9所述的系统，还包括：
器械对齐引导件，其限定具有内径的内部孔口。
16.根据权利要求15所述的系统，还包括：
所述对齐销钉或第二对齐销钉中的至少一个，其中，所述对齐销钉或第二对齐销钉中的所述至少一个的每个具有小于所述器械对齐引导件的内径的外径。
17.根据权利要求16所述的系统，还包括：
配置用于附接到所述器械对齐引导件的器械。
18.一种利用髋臼引导系统在髋臼附近安放引导销钉的方法，包括：
基于特定患者的髋臼的几何形状，将髋臼引导件的外部弯曲表面定位在髋臼中，其中，所述外部弯曲表面具有基本匹配特定患者的髋臼的几何形状；
使销钉引导件与中央柱体相互连接；
绕所述中央柱体转动所述销钉引导件，以相对于所述中央柱体定位所述销钉引导件的引导件本体。
19.根据权利要求18所述的方法，还包括：
选择所述引导件本体相对于所述中央柱体的位置，并将所述引导件本体转动到选定的位置；以及
使所述销钉引导件靠置在所述髋臼引导件的选定的边缘部分上。
20.根据权利要求19所述的方法，还包括：
从第一边缘部分和间隔开的第二边缘部分选择所述选定的边缘部分；
其中，所述第一边缘部分和所述第二边缘部分中的每个包括用于支撑所述销钉引导件的表面。
21.根据权利要求19所述的方法，还包括：
相对于所述销钉引导件的第二臂部沿纵向移动第一臂部；
其中，相对于所述销钉引导件的第二臂部沿纵向移动第一臂部导致相对于所述中央柱体线性地平移所述引导件本体。
22.根据权利要求21所述的方法，还包括：
在所述髋臼附近在所述选定的位置安装对齐销钉，使其穿过所述引导件本体。
23.根据权利要求22所述的方法，还包括：
提供具有孔口的器械引导件，所述孔口具有大于所述对齐销钉的外径的内径。
24.根据权利要求23所述的方法，还包括：
至少由于所述孔口的内径大于所述对齐销钉的外径，从由所述对齐销钉限定的轴线移动器械。
25.根据权利要求24所述的方法，还包括：
在所述器械被连接到所述器械引导件而所述器械引导件连接到所述对齐销钉的情况下，将髋臼假体安放在髋臼中。
26.一种形成用于在髋臼附近安放引导销钉的髋臼引导系统的方法，包括：
基于特定患者的髋臼的几何形状，形成髋臼引导件的具有如下几何形状的外部弯曲表面，所述几何形状基本匹配特定患者的髋臼；
形成从所述髋臼引导件的内表面沿柱体长轴线延伸的中央柱体；和
形成销钉引导件，所述销钉引导件配置用于连接到所述中央柱体以绕所述中央柱体转动，从而相对于所述中央柱体定位所述销钉引导件的引导件本体。
27.根据权利要求26所述的方法，还包括：
形成所述髋臼引导件的第一平坦边缘部；
形成髋臼引导件的第二平坦边缘部；
其中，所述第一平坦部被定位用于前侧入路手术，所述第二平坦边缘部被定位用于后外侧入路手术。
28.根据权利要求26所述的方法，还包括将所述销钉引导件形成为具有第一臂和第二臂，所述第一臂相对于第二臂可移动以选择所述引导件本体与所述中央柱体的距离。
29.根据权利要求26所述的方法，还包括：
形成器械引导件，所述器械引导件限定具有内径的中央引导孔口；
在对齐销钉上移动所述器械引导件，其中，所述对齐销钉包括小于所述内径的外径。
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