CN107666885A - 髋臼引导系统及放置引导销的方法 - Google Patents

髋臼引导系统及放置引导销的方法 Download PDF

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CN107666885A
CN107666885A CN201680031024.0A CN201680031024A CN107666885A CN 107666885 A CN107666885 A CN 107666885A CN 201680031024 A CN201680031024 A CN 201680031024A CN 107666885 A CN107666885 A CN 107666885A
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acetabular bone
unit
plug
patient
guiding device
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CN107666885B (zh
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T·D·维特
A·达文波特
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Special Single Liability Co That Is Constructed With Of Bai Ou Meter
Biomet Manufacturing LLC
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1742—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hip
    • A61B17/1746—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hip for the acetabulum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8872—Instruments for putting said fixation devices against or away from the bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • 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
    • 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
    • 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
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4609—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of acetabular cups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B2017/568—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor produced with shape and dimensions specific for an individual patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides

Abstract

一种用于将引导销放置在髋臼附近的髋臼引导系统包括患者特定髋臼引导器，其可以包括内表面和外表面，外表面构造成具有配准到特定患者的髋臼内的几何结构，第一钻插件，其配置为在第一位置处由所述引导器接收，第一钻插件具有被构造成同心地接收在引导器的引导孔中的第一纵向孔，所述引导孔延伸至所述内表面外面，第二钻插件，其配置为在距所述第一位置预定距离的第二位置处固定到位于所述髋臼外面的骨部分，第二钻插件形成第二纵向孔，以及可选择性移除的对准销，其配置为由所述第一纵向孔和所述第二纵向孔中的至少一个接收。

Description

髋臼引导系统及放置引导销的方法
相关申请的交叉引用
本申请要求于2015年3月30日提交的美国专利申请序列No.14/673,230的优先权，其内容被整体通过引用方式并入本文。
发明内容
为了更好地说明这里公开的器械，这里提供了非限制性的例子列表：
在示例1中，可以提供一种用于将引导销放置在髋臼附近的髋臼引导系统，其包括患者特定髋臼引导器，患者特定髋臼引导器包括内表面和外表面，所述外表面可以构造成具有配准到特定患者的髋臼内的几何结构，第一钻插件可以配置为在第一位置处由所述患者特定髋臼引导器接收，所述第一钻插件可以具有第一纵向孔，所述第一纵向孔可以构造成同心地接收在所述患者特定髋臼引导器的引导孔中，所述引导孔可以延伸至所述内表面外面，第二钻插件可以配置为在距所述第一位置预定距离的第二位置处固定到位于所述髋臼外面的骨部分，所述第二钻插件可以形成第二纵向孔，并且可选择性移除的对准销可以配置为由所述第一纵向孔和所述第二纵向孔中的至少一个接收。
在示例2中，示例1的髋臼引导系统被可选地构造成使所述第二钻插件可以包括近侧部分和远侧部分，所述远侧部分包括至少一个防退出特征。
在示例3中，示例2的髋臼引导器被可选地构造成使所述至少一个防退出特征包括从所述远侧部分的外表面延伸的螺纹和翼部中的至少一个。
在示例4中，示例2的髋臼引导器被可选地构造成使所述近侧部分能够被驱动器接合，所述驱动器被配置用于旋转所述近侧部分，由此将所述远侧部分驱动到所述位于髋臼外面的骨部分中。
在示例5中，示例4的髋臼引导系统还包括被配置成将所述对准销联接到所述驱动器的联接机构。
在示例6中，示例5的髋臼引导系统被可选地构造成使得，经由所述联接机构，所述驱动器被围绕着所述对准销旋转至相对于所述髋臼的预定位置。
在示例7中，示例6的髋臼引导系统被可选地构造成使在与所述预定位置相关的第二位置处所述驱动器将所述第二钻插件驱动到骨内。
在示例8中，示例7的髋臼引导系统被可选地构造成使所述对准销被配置为从所述第一钻插件选择性地移除并组装到所述第二钻插件。
在示例9中，可以提供一种利用髋臼引导系统将引导销放置在髋臼附近的方法，包括提供患者特定髋臼引导器，包括将所述患者特定髋臼引导器的外表面形成为具有配准到特定患者的髋臼内的几何结构，提供第一钻插件，所述第一钻插件具有第一纵向孔，所述第一纵向孔被构造成同心地接收在所述患者特定髋臼引导器的引导孔中，所述引导孔延伸到所述患者特定髋臼引导器的内表面外面，以在第一位置处对准所述第一钻插件，提供第二钻插件，所述第二钻插件具有第二纵向孔并且被配置为在距所述第一位置预定距离的第二位置处固定到骨头部分，以及提供可选择性移除的对准销，所述对准销被配置为由所述第一纵向孔或所述第二纵向孔中的至少一个接收。
在示例10中，示例9的方法被可选地构造成使得，将所述患者特定髋臼引导器的外表面形成为被构造成具有配准到特定患者的髋臼内的几何结构包括获取所述特定患者的图像和将所述患者特定髋臼引导器的外表面设计为具有与所述特定患者的髋臼相配合的配合表面。
在示例11中，示例9或示例10的方法被可选地构造成使得，提供所述第二钻插件包括提供近侧部分和在远侧部分上提供至少一个防退出特征。
在示例12中，示例11的方法还包括接合所述近侧部分以便在所述第二位置处将所述远侧部分驱动到位于骨部分内，以及将所述对准销组装到所述第二钻插件中。
在示例13中，示例12的方法还包括在将所述第二钻插件保持于所述骨部分中的同时从所述第二钻插件选择性地移除所述对准销。
在示例14中，示例11-13中任一个的方法还包括将所述对准销联接到驱动器，所述驱动器被配置为在距所述第一位置预定距离的第二位置处将所述第二钻插件驱动到所述骨部分内。
在示例15中，示例14的方法还包括在所述第二位置处通过所述驱动器将所述第二钻插件驱动到所述骨部分中。
在示例16中，示例15的方法还包括从所述第一钻插件选择性地移除所述对准销并将所述对准销定位到所述第二钻插件中。
在示例17中，可以提供一种植入髋臼植入物的方法，包括形成患者特定髋臼引导器，所述患者特定髋臼引导器具有外表面，所述外表面具有被形成为配准到特定患者的髋臼内的几何结构，在相对于所述髋臼的第一位置处将第一钻插件连接到所述患者特定髋臼引导器，所述第一钻插件具有第一纵向孔，所述第一纵向孔被构造成同心地接收在所述患者特定髋臼引导器的引导孔中，所述引导孔延伸到所述内表面外面，以在第一位置处对准所述第一钻插件，在所述第一位置处将对准销固定到骨的第一部分，所述对准销由所述第一纵向孔接收，移除患者特定髋臼引导器和第一钻插件，将驱动器联接到对准销，在第二位置处利用所述驱动器将具有第二纵向孔的第二钻插件驱动到骨的第二部分内，所述第二位置距所述第一位置预定距离，并且从第一钻插件选择性地移除对准销。
在示例18中，示例17的方法还包括在所述第二位置处将所述对准销固定到所述骨的第二部分，所述对准销由所述第二纵向孔接收。
在示例19中，示例18的方法还包括从所述第二钻插件选择性地移除所述对准销。
在示例20中，示例19的方法还包括在从所述第一钻插件移除所述对准销之后对所述髋臼进行扩孔。
在示例21中，示例20的方法还包括在对所述髋臼进行扩孔之后插入所述对准销使其穿过所述第二钻插件的所述第二纵向孔。
在示例22中，示例21的方法还包括基于由所述对准销限定的轴线将髋臼植入物植入到被扩孔的髋臼中。
在示例23中，示例1-22中的任何一个或任何组合的设备，系统或方法可以可选地构造成使得所列举的所有元件或选项可以进行使用或可以从中进行选择。
本装置，系统和方法的这些和其他示例和特征将在下面的具体实施方式中详细阐述。本概述旨在提供本专利申请的主题的概述。不意图提供本发明的排他性或详尽的阐述。下面的详细描述用于提供关于本专利申请的进一步信息。
附图说明
从下面的详细描述和附图中本教导将得到更充分地理解，其中：
图1A是根据本教导的患者特定髋臼导向器的前面等轴测视图；
图1B是图1A的患者特定髋臼引导器的侧面等轴测视图；
图1C是根据本教导的替代性钻插件的透视图；
图2A是根据本教导的、具有插件手柄的患者特定髋臼引导器的俯视等轴测视图；
图2B是根据本教导的、具有插件手柄的患者特定髋臼引导器的侧视平面图；
图3A是图1的患者特定髋臼引导器的等轴测环境视图；
图3B是带有被附接的插件的、图1的患者特定髋臼引导器的等轴测环境视图；
图4是图1的患者特定髋臼引导器和对准销的另一等轴测环境视图；
图5是髋臼植入物的等轴测环境视图；
图6A-6B是髋臼和替代钻插件和对准销的等轴测环境视图；
图7是图6A-6B的髋臼和工具和替代钻插件和对准销的等轴测环境视图；
图8是包括钻插件的图1的患者特定髋臼引导器的等轴测环境视图；
图9-10是包括工具和联接器的图8的等轴测环境视图；和
图11A-11B是图8的等轴测环境视图，示出了对准销的移除和重新组装。
贯穿附图中的多个视图，对应的附图标记表示对应的部分。
具体实施方式
以下描述在本质上仅仅是示例性的，并且决不旨在限制本教导，应用或使用。
本教导总体上提供用于矫形手术中、例如用于髋关节的置换或修复手术中的患者特定髋臼对准引导器，插件和/或其它相关器械。患者特定对准引导器和相关的器械可以与传统的植入物部件一起使用，或者可以与基于特定患者的医疗扫描、利用计算机辅助成像方法制备的患者特定植入物部件一起使用。
本教导提供了用于通常制备患者的髋臼以沿着对准轴线接收髋臼植入物(例如，髋臼杯)的各种器械和方法。可以在术前计划期间利用患者的相关解剖学结构(诸如骨盆或其部分)的三维重建来设计对准轴线，各种患者特定引导器以及其他相关器械。三维重建可以基于医学图像。
本教导提供了例如可用于制备患者的髋臼以接收髋臼植入物(例如髋臼杯)的患者特定髋臼引导器。髋臼引导器具有圆顶形本体，该圆顶形本体具有周边环形边沿和外部三维表面，该外部三维表面被构造成匹配在患者的术前计划期间从患者的髋关节的三维医学图像获得的特定患者髋关节的髋臼。患者特定配准引导器可以永久地或可拆卸地连接到周边边沿。患者特定配准引导器具有纵向孔，该纵向孔限定具有对准取向的患者特定的对准轴线，该对准取向被配置为在患者术前计划期间引导患者的髋臼植入物。配准引导器具有被构造成与患者髋臼的髋臼周围表面和/或髋臼沿表面的对应部分匹配的患者特定底表面。
用于将引导销放置在髋臼附近的髋臼引导系统，包括患者特定髋臼引导器，其包括内表面和外表面，所述外表面被构造成具有配准到特定患者的髋臼内的几何结构，第一钻插件，其被配置为在第一位置处由所述引导器接收，所述第一钻插件具有第一纵向孔，所述第一纵向孔被构造成同心地接收在所述引导器的引导孔中，所述引导孔延伸至所述内表面外面，第二钻插件，其被配置为在距所述第一位置预定距离的第二位置处固定到位于所述髋臼外面的骨部分，所述第二钻插件形成第二纵向孔，以及可选择性移除的对准销，其被配置为由所述第一纵向孔和所述第二纵向孔中的至少一个接收。
在其他特征中，利用髋臼引导系统将引导销放置在髋臼附近的方法包括提供患者特定髋臼引导器，包括将所述患者特定髋臼引导器的外表面形成为具有配准到特定患者的髋臼内的几何结构，提供第一钻插件，所述第一钻插件具有第一纵向孔，所述第一纵向孔被构造成同心地接收在所述患者特定髋臼引导器的引导孔中，所述引导孔延伸到所述患者特定髋臼引导器的内表面外面，以在第一位置处对准所述第一钻插件，提供第二钻插件，所述第二钻插件具有第二纵向孔并且被配置为在距所述第一位置预定距离的第二位置处固定到骨头部分，以及提供可选择性移除的对准销，所述对准销被配置为由所述第一纵向孔或所述第二纵向孔中的至少一个接收。
在又其他特征中，植入髋臼植入物的方法包括形成患者特定髋臼引导器，所述患者特定髋臼引导器具有外表面，所述外表面具有被形成为配准到特定患者的髋臼内的几何结构，在相对于所述髋臼的第一位置处将第一钻插件连接到所述患者特定髋臼引导器，所述第一钻插件具有第一纵向孔，所述第一纵向孔被构造成同心地接收在所述患者特定髋臼引导器的引导孔中，所述引导孔延伸到所述内表面外面，以在第一位置处对准所述第一钻插件，在所述第一位置处将对准销固定到骨的第一部分，所述对准销由所述第一纵向孔接收，移除患者特定髋臼引导器和第一钻插件，将驱动器联接到对准销，在第二位置处利用所述驱动器将具有第二纵向孔的第二钻插件驱动到骨的第二部分内，所述第二位置距所述第一位置预定距离，并且从第一钻插件选择性地移除对准销。
如在2012年1月1日授权的美国专利No.8,092,465、和在2012年2月21日提交的美国专利申请公开文献No.2012/0226283、以及在2014年3月11日提交的美国专利申请公开文献No.2014/0276873中所述的，在术前计划阶段期间，患者的相关解剖结构的成像数据可以在包括医生办公室的设施中获得，其中所有这些申请被以引用方式并入本文。此成像数据可以包括例如对骨盆，髋关节，膝关节，踝关节或其他关节或者患者解剖结构的相关部分的详细扫描。成像数据可以使用MRI，CT，和X射线，超声或任何其他成像系统来获得。所获得的成像数据可用于构建患者解剖结构的关节或其他部分的三维计算机图像，以及准备可包括骨或关节准备发初始计划方案，比如计划切除，铣削，扩孔(ream)，拉孔(broach)，以及植入物选择和装配，设计患者特定引导器，设计模板，设计工具和用于外科手术的对准协议。另外，可以准备患者的关节和相关骨头的物理模型，以在手术过程之前使引导器和植入物进行可视和对其进行试验。
用于获得相关患者解剖结构的三维计算机图像的计算机建模可以通过各种计算机辅助绘图(CAD)程序，应用程序和/或可从各种销售商或开发商商购获得的软件来提供，例如从加拿大蒙特利尔的Object Research Systems或ORS获得。计算机建模程序或其他应用程序可以被配置和用于计划术前手术计划，包括计划各种骨准备程序，选择或设计/修改植入物和设计患者特定引导器和工具。特定患者引导器和工具可包括患者特定假体部件和患者特定工具，包括扩孔，拉削，铣削，钻孔或切割工具，对准引导器，模板和其他患者特定器械。
术前计划可以存储在任何计算机存储介质中，以计算机文件或任何其他计算机或数字报告的形式，包括三维图形文件或数字数据集。与交互式软件或其他应用程序相关联的数字形式的术前计划可以通过硬介质、基于网络的或移动通信或云的服务，或可以访问蜂窝网络的便携式设备而变得可用。该计划可以通过各种系统或媒介提供给外科医生或其他医务人员进行审查。使用交互式软件或应用程序，外科医生可以检查该计划，并且相对于解剖结构的图像操纵各植入物部件的图像的位置。外科医生可以修改该计划并将其发送给制造商并提供建议或更改。交互式审查过程可能会重复，直到最终批准的计划被发送到制造工厂以准备真正的实体部件。在各实施例中，可以在术前将实体和数字的患者特定骨模型，引导器和器械提供给外科医生进行试验和标记。
在手术计划被外科医生批准之后，患者特定植入物和相关工具(包括例如对准引导器，切割/铣削/扩孔/拉削或用于手术准备特定患者的关节或其他解剖部分的其他工具)可以使用CAD程序或其他三维建模软件(例如由加拿大蒙特利尔的Object ResearchSystems或ORS提供的软件)、例如根据术前手术计划来设计。可以通过各种立体平版印刷方法，选择性激光烧结，熔融沉积造型，或其他快速成型方法，和/或计算机控制加工来制造患者特定引导器和其他器械。在一些实施例中，可以生成用于加工患者特定引导器和/或植入物的工具路径的计算机指令并将其存储在工具路径数据文件中。刀具路径数据可以作为输入提供给CNC磨床或其他自动化加工系统，并且这些工具和植入物可以根据用途由聚合物，陶瓷，金属或其他合适的材料机加工，并且被消毒。灭菌后的工具和植入物可被运送到外科手术或医疗机构以在手术过程中使用。
患者特定植入物，引导器，模板，工具或其部分在本文中被由患者的术前图像扫描重建的特定患者解剖结构的三维图像进行定义，如通过用于特定患者的术前计划构建的那些。患者特定部件被构造成紧密符合至并且配合或基本匹配至患者解剖结构的表面。配合或匹配通常作为患者解剖结构的相应表面部分的阴模，阴面或反面或镜像面。根据特定的过程，植入物和工具的使用，解剖学表面可以包括具有或不具有相关软组织、比如关节软骨的骨表面。患者关节表面的微小不规则处(例如那些不影响引导器的放置的不规则处)不需要被镜像。
如上所述，患者特定对准引导器和植入物通常被配置为匹配特定患者的解剖结构并且在特定患者的对应表面上的仅一个位置处适配/配准到患者，因为对于每个患者来说都是唯一性的解剖特征可以用作标记，并且可以在仅一个位置中引导对准引导器或植入物的放置，而不需要术中图像导航，患者标记或其他术中引导。通常基于患者的3D解剖图像利用计算机建模来配置和制造患者特定对准引导器，所述患者特定对准引导器具有接合表面，该接合表面被制造为如上所述一致地接触和匹配到患者骨表面(具有或不具有软骨或其他软组织)的三维图像/模型的对应表面，通过上面讨论的计算机方法。
通常，患者特定引导器具有直接接触特定患者解剖结构的选定区域的选定部分的外表面。例如，患者特定引导器可以包括当被正确定位时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，髋臼引导器的外部圆顶形表面)，包括约90％接触和约98％接触。因此，患者匹配的引导器的外表面可以与解剖结构的选定部分实质上匹配。然而，应该理解的是，患者特定引导器的某些外部部分可能不与患者实质接触，而其他部分设计成即使在其他部分不与患者接触时也要确保接触。因此，患者匹配的引导器可以具有实质上患者匹配的部分，并且具有或可以实现与患者的选定量的接触。
患者特定对准引导器可以包括一个或多个定制的引导结构，例如引导孔或者空心引导柱或者空心引导延伸部或者插口，其可以用于支撑或者引导其他器械，比如钻引导器，扩孔刀，刀具，切割引导器和切割块，或者根据外科医生批准的术前计划用于插入销或其他紧固件。患者特定对准引导器可以用于微创手术，也可以用于具有多个微创切口的手术。各种对准引导器和术前计划过程在下述中公开了：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号；2009年1月22日公开的美国文献No.2009/0024131；日期为2008年5月15日的美国文献No.2008/0114370，目前为美国专利No.8,298,237，其于2012年10月30日获得授权；2011年11月15日公开的美国文献No.2011/0224674；2011年7月28日公开的美国文献No.2011/0184419；以及2012年9月6日公开的美国文献No.2012/0226283，所有专利和申请都被以引用方式并入本文。
参考图1A-3B，本教导提供了患者特定髋臼引导器100和髋臼引导器插件300。髋臼引导器100可以与各种其它器械结合使用，以总体上提供患者特定对准轴线A。患者特定对准轴线A用于插入对准销230并且通常用于将髋臼植入物或髋臼杯250定向、插入和植入患者的髋臼(或髋臼腔)82中，以便于髋臼82的被引导的扩孔，并且相对于对准轴线A或对准销230总体上引导任何器械和过程。对准轴线A被在术前计划期间从患者的髋关节的三维图像中确定为髋臼植入物250将沿其插入的轴线。对准轴线A大致垂直于髋臼82以及髋臼植入物250的对应髋臼接合表面252。更具体地说，参照图3B，可以相对于骨盆80的轴向平面(AP)，矢状平面(SP)和骨盆前平面(APP)选择和指定对准轴线A的取向(即，角度)。冠状平面是垂直于轴向平面和矢状平面的竖直平面(未示出)。骨盆前平面(APP)被定义为经过患者骨盆80的两个髂前棘(anterior iliac spines)和耻骨联合(pubic symphysis)的平面。当在患者的负重轮廓(站立)中观察时，APP可能从与冠状平面的平行中偏离。另外，APP平面在仰卧位可以具有不同的取向。此偏离量因患者而异，使得在没有额外信息的情况下外科医生无法依靠骨盆前平面来引导髋臼植入物和避免运动期间的撞击。骨盆前平面与冠状平面之间的角度可以称为骨盆倾角，并且当骨盆前平面与冠状平面平行时为零。本教导将确定用来插入髋臼植入物的患者特定轴线。通过利用患者特定髋臼引导器插入到骨内的对准销230的取向以及在术前计划期间引入到髋臼引导器内的标记配准(registration)来物理地、且唯一地确定出患者特定的对准轴线。具体而言，基于患者的髋关节图像的术前计划可以准确地确定对准轴线A的取向，并且通过患者骨盆80上的患者特定髋臼引导器100在术中进行固定，以在手术过程中引导外科医生。
患者特定髋臼引导器100可以在唯一(仅一个)位置接合并配准特定患者的髋臼82，并且可以提供相对于髋臼植入物250(图1)的计划取向的精确对准轴线A(图4)。在重量轻且尺寸紧凑且体积小的设计中，患者特定髋臼引导器100还可以提供牢固的安装和旋转稳定性。
图1A-3B示出了具有圆顶形本体102的患者特定髋臼引导器100，圆顶形本体102具有被构造成接触和接合髋臼82的三维的患者特定底表面或外表面104。外表面104被设计和/或形成为匹配来自患者髋关节的三维图像的髋臼82的对应表面的负面。因此，外表面104被形成为当定位在髋臼82中时紧密配合、比如接触髋臼82的大约85％至大约100％。因此，引导器100的外表面104包括可以镜像或匹配髋臼82的表面。
患者特定髋臼引导器100的圆顶形本体102可以具有窗口106形式的一个或多个开口，用于减小患者特定髋臼引导器100的重量并提供对下面的解剖结构的改进的可视性。圆顶形本体102还可以包括附加孔或其它孔口109，所述附加孔或其它孔口用于在髋臼82中钻孔并且对应于用于髋臼植入物250的固定螺钉的孔254。患者特定髋臼引导器100的圆顶形本体102由引导器边沿108界定，所述引导器边沿呈闭合轮廓式的周边环形表面的形式，该环形表面可以具有不平整的、不规则的、锯齿形的或波浪形的形状，遵循患者髋臼82周围的髋臼边沿84(和髋臼周围表面)的对应形状。
另外，患者特定髋臼引导器100可以包括一个或多个配准钩，也称为延伸部或凸缘110，它们沿着围绕髋臼边沿84的三维曲面、在不同的且间隔开的位置处从引导器边沿108伸出。配准钩110被配置成通过以患者特定的方式复制髋臼边沿84的相应下面表面部分或标记来为患者特定髋臼引导器100提供额外的配准位置。具体而言，每个配准钩110可以具有弯曲的(三维的)底表面112，该弯曲的(三维的)底表面112是患者特定的，并且是在患者的术前计划期间被选择为标记位置的特定位置处的、髋臼边沿84的表面的负面。每个配准钩110可以包括孔114，用于接收固定销或其他固定元件(未示出)以将患者特定髋臼引导器100附接到患者的骨盆。另外，配准钩110可以包括加强脊或肋。选定的加强肋包括在2013年3月8日提交的美国专利申请No.13/790,770中图示和描述的那些，其被通过引用方式并入本文。
患者特定髋臼引导器100可以包括可移除的或不可移除的配准和对准引导器120(简称为配准引导器120)，其具有沿着患者特定对准取向A的纵向孔124。可移除的钻插件122具有纵向孔126，该纵向孔可被同心地接收在配准引导器120的孔124中。配准引导器120的孔124的壁可以限定出锥形部，所述锥形部与可移除的钻插件122的端部的互补锥形部127接合。这些互补的锥形部可以确保孔124和插入孔126的适当的和选择的对准。因此，孔124和插入孔126可以是同心且共同延伸的。
钻插件122可以在对准销230的插入期间提供稳定性和耐磨性。对准销230可被沿着对准轴线A插入并且进一步具有纵向轴线，所以该纵向轴线沿着对准轴线A延伸。对准销230可以包括能够钻入到髋臼82的骨内或其附近的骨内的钻尖端231。对准销230被接收在对准引导器120和钻插件122的同心孔124，126中。因此，对准销230沿着对准轴线A定向。
钻插件122可以由坚韧和/或坚固的材料形成。例如，钻插件122可以是金属的并且是可重复使用的，而配准引导器120和髋臼引导器100是患者特定的并且可以由诸如聚合物材料的较软材料制成，并且可以是一次性的。钻插件122的坚韧材料可以接合对准销230而不会变形和/或磨损，以保护配准引导器120免于由于接合对准销230而受到损坏。此外，在插入销230的过程中，钻插件122通常形成为不会磨损到足以允许销230移离对准轴线A的程度。
在一些实施例中，钻插件122包括近侧部分125和远侧部分129。远侧部分129可以包括多个骨接合翅部127a和多个螺纹中的一者，所述多个螺纹比如是图1C中所示的自攻螺纹127b。应该理解的是，虽然本文仅描述了翅部和螺纹，但是钻插件122可以包括任何合适的固定和/或防退出特征。翅部127a和螺纹127b中每一者被构造成在髋臼82处或其附近钻入骨中，并阻止钻插件122从骨头中退出。然而，应该理解，可以提供多个钻插件或销引导器。如本文所讨论的，具有翅部127a或螺纹127b的那些可以不直接接合引导器100。
简要地参考图7和8，工具、例如驱动器包括手柄504，轴508和插口部分512。插口部分512构造成接合钻插件122的近侧部分125。例如，插口部分512包括远侧开口516。远侧开口516构造成接收钻插件122的近侧部分125，诸如在插口部分512的内壁内。内壁可以形成六边形接合或其他适当的接合。
如下面将要描述的那样，插口部分512可以接合近侧部分并且例如利用手柄504沿着轴线A驱动或移动插件122。当接合部分接合近侧部分125时，钻插件122被推动，使得翅部127a接合骨并将远侧部分129驱动到骨中。应该理解的是，虽然钻孔插件122显示为具有翼部127a，但是本文的原理适用于包括螺纹127b或任何合适的防退出特征的钻插件。
轴508构造成在手柄504和插口部分512之间提供足够的长度。例如，轴508可以提供足够长的长度以供外科医生操作驱动器500而不必进入患者的解剖结构内。可以理解，轴508可以具有任何合适的长度。
手柄504被配置成接收外科医生的手，用于驱动器500的操作。在使用中，外科医生可相对于轴线A旋转手柄，从而使插口部分512接合近侧部分125并将远侧部分129驱动到骨内，如上所述。而且，可以使用锤子或其他工具来冲击或转动驱动器500。
如图7所示，驱动器500包括通孔520。通孔520同心地穿过手柄504，轴508和插口部分512。此外，当接合钻插件122时，通孔520可以与钻插件122的插入孔126同心并共同延伸。以这种方式，对准销230可穿过驱动器500并穿过钻插件122。在外科医生将钻插件122钻入骨中之后，可沿着轴线A移除驱动器500，而对准销230保持组装在钻插件122中。
图8示出组装在钻插件122中的对准销230。在一些实施方式中，钻插件122可以包括设置在钻插件122的远侧部分129上的翅部127a或螺纹127b，如关于图1C所描述的。翅部127a可以同心地接收在配准引导器120的孔124中。因此，任何其他合适的防退出特征或者如图8所示不具有防退出特征都可以与引导器100一起使用。
配准引导器120可以具有底表面部分，该底表面部分是患者特定的底表面128，其可以在患者的术前计划期间确定的预定标记位置处钩在引导器边沿108四周或卡合或以其他方式接合并接触引导器边沿108。包括患者特定底表面128的配准引导器120在相应的位置处与患者的髋臼边沿84的表面和/或骨盆80的髋臼周围区域匹配。
配准引导器120的孔124和钻插件122的孔126可具有限定纵向狭缝133的开放式(即不连续)周边。狭缝133可构造成允许在不移除被插入骨盆80中并且定义出对准轴线A的对准销230的情况下将患者特定髋臼引导器100从患者的骨盆80移除。换句话说，也可以通过相对于狭缝133和纵向轴线A侧向或横向移动、而不必须仅仅通过沿着对准轴线A或沿着对准销230运动来移除患者特定髋臼引导器100。
患者特定髋臼引导器100可以包括第一柱130和可选的第二柱132(以假想线示出)。这两个柱130，132可以从患者特定髋臼引导器100的圆顶形本体102的内表面105(与外表面104相反)延伸。如本文所讨论的，柱130有助于引导器100的放置和对准。此外，可以理解的是，第二柱132是可选的，引导器100不必须包括。
可选地，第一柱130可以限定穿过髋臼引导器的圆顶形本体102的孔，用于使用销或其它紧固件可选地固定到髋臼82。然而，此孔不是必需的，并且柱130可以是封闭的中空柱或实心柱。第一柱130可被居中地定位并且相对于患者特定髋臼引导器100的圆顶形本体102的切线以及下面的髋臼82表面垂直。可选的第二支柱132(如果包括的话)可以相对于第一支柱130在相对于引导器边沿108的周边的径向方向上偏置。第二柱132的高度可以相对于第一支柱130更短。柱130，132可用于使用髋臼引导器插件(诸如图2-3B所示的髋臼引导器插件300)来将患者特定髋臼引导器100插入。
柱130可以是从引导器100伸出并与引导器100一起形成的插入和对准柱。然而，进一步理解的是，插入柱130可以以任何适当的方式与引导器100相互连接，例如使用粘合剂或其他固定机构。无论如何，柱130可以形成为包括非圆形或非圆柱形形状。例如，柱130可以包括梯形，卵形，长方形或其他选定的形状。可以在柱130的横截面中和/或沿着柱130的高度延伸的轴线观察到所述非圆形形状。
柱130可以包括柱对准轴线130a，其可以具有相对于引导器100、特别是相对于穿过配准引导器120的对准轴线A的特定取向。如本文进一步讨论的，对准轴线130a可以用于使引导器100相对于解剖结构的选定部分(包括解剖学标记)对准。可以在患者图像中、例如在计划手术期间预先确定解剖学标记。因此，包括柱对准轴线130a的柱130可以辅助使引导器100相对于骨盆80中的髋臼82在旋转方面实现对准。此外，柱130的非圆形形状可以辅助相对于选定的插件300(图2A和2B)保持和接合引导器100，如本文进一步讨论的。而且，柱130可以包括朝向唯一引导器100的内表面105附近的柱130基部131渐变的外部几何结构。同样，如本文进一步讨论的，柱130的锥形部可以辅助引导器相对于插件300的接合和固定。
特别参照图2A和图2B，插件300可以在第一端部302附近接合第一柱130，第一端部302限定内孔或捕捉区域304，该内孔或捕捉区域304被与柱130的上部或顶部133互补地成形和/或匹配。如上所述，中心柱130的形状可以限定柱对准轴线130a。一旦插件300接合柱130，插件300的互补内孔304也可以限定与柱对准轴线130a匹配或对准的插件孔轴线。相应地，器械300以选定和键合的方式接合和可连接到柱130。以键合的方式，插件300以选定的单一取向和位置接合柱130，这也允许插件300被定位在相对于引导器100的单一取向和位置。因此，插件300可以与引导器100以选定的单一取向和位置相互连接，以允许相对于骨盆80操纵引导器。
轴306的第一端部302可以进一步包括接合柱130的外锥形部的锥形部。与柱体130的外锥形部连接的接收孔304的凹锥形部可以帮助相对于插件手柄300保持和固定柱130和引导器100。然而，应该理解的是，还可以提供额外的附接机构，比如干涉配合、卡合配合、相对于手柄300接合柱130的螺钉或螺栓，或其他适当的连接机构。
另外，插件300可以包括延伸到手柄308的轴306。手柄308可被使用者抓住以相对于引导器100操纵插件300使其接合柱130。一旦插件300被联接到柱130，则在插件300接合到柱130上之后插件可以使导向器100相对于骨盆80进一步平移和旋转。
另外，插件300可以包括对准部分，诸如夹具或对准杆310，其可以在接合或联接区域312处联接到轴306和/或与轴306一起形成。在插入和定位引导器100期间，使用者可以在患者的软组织外面看到对准部分。因此，当插件300以单一位置和取向接合柱130时，用户可以通过观察对准部分而知道引导器100的对准。
联接区域312可以包括内螺纹以接合对准夹具或杆310的外螺纹。然而，另外还可以提供其它的连接机构，诸如允许对准夹具或杆直接接触解剖结构或软组织的预定部分的开槽孔。可替代地，对准部分(例如对准夹具310)可以与轴306永久地固定在一起或与轴306制造为单一件。然而，对准夹具310可以从轴306沿着对准部分或夹具轴线310a延伸。对准夹具310的对准部分轴线310a可以形成为与柱130的柱对准轴线130a对准。因为柱130以单一选定的和预定的位置和取向接合轴306中的内孔304，所以轴306将以基本上单一的取向和位置与柱130接合并对准。因此，限定对准轴线310a的对准夹具310与柱130的轴线130a对准。然而，应该理解的是，出于本文进一步讨论的目的，不需要对准夹具310，接合柱130的手柄300就可以为使用者提供适当的固定和对准。
参照图3A和3B，引导器100可以以选定的方式定位在骨盆80的髋臼82中。如上所述，中心柱130限定了柱对准轴线130a。当插件300与轴线130a对准时，由于孔304与柱130的接合，手柄300可以从患者外面从视觉上观察到。另外，对准夹具310也可以定位在轴306的一部分上，使其在导向器100定位在髋臼82附近或髋臼82内时也位于患者的外面。可以理解的是，当从患者外面观看时，诸如外科医生的使用者可以在将引导器100定位在髋臼82内的时候具有对准夹具310和/或插件300的一部分的清晰视野。
由于引导器100被定位在髋臼82内，所以柱对准轴线130a可以延伸到引导器100外面，以允许与骨盆的一部分(比如，解剖学标志400，可以包括髂前上棘(ASIS))对准。可以预先确定解剖学标志，例如在手术的计划过程中。穿过对准引导器120的对准轴线A也可以在预先计划的过程中选择。这样，引导器100的设计可以基于预定标记和对准轴线A的预定位置进行。然后，引导器100可以制造成具有柱130，柱130具有相对于对准轴线A形成的柱对准轴线130a，这样柱对准轴线130a与预定标记的对准将使对准轴线A处于预定位置和取向。
因此，轴线A相对于髋臼82的位置可以预先确定，并且可以相对于骨盆80定位，由于引导器100被配准在髋臼82内。如上所述，引导器100被基本上仅在单一位置和取向上配准到髋臼82内(即，通过引导器100的外表面104与髋臼82的总体匹配或接触)。相应地，手柄300可以用于沿着箭头410的方向定位和旋转引导器100。插件300可用于在箭头410的任一方向或两个方向上掠过选定长度的弧。限定出与柱对准轴线130a对准的夹具轴线310a的对准夹具310可以全部设计成确保当对准轴线A处于患者体内所选定的预先计划位置时获得引导器100的配准。相应地，通过移动手柄300，如在图2A和图2B中示出的，外科医生可以清楚地观察到对准夹具310相对于患者的各种标记，诸如ASIS 400，比如从患者软组织外面。
旋转该引导器100可以使中心柱130的柱对准轴线130a相对于骨盆80移动。例如，如图3B所示，柱130的柱对准轴线130a可被定位成指向骨盆80的髂嵴420或与其对准。中心柱130的柱对准轴线130a'的定位也使夹具320的夹具轴线310A'与髂嵴420对准。在手术期间，外科医生可以观察到对准夹具310与髂嵴420定向或对准，并且确定引导器100必须向前旋转或朝向耻骨430旋转。然后使用者可以根据需要旋转插件300和引导器100，并且总体上沿着箭头410中的一个的方向旋转。这样，使用者可以确定引导器100的正确移动，以相对于诸如ASIS 400的预选标记对引导器进行定位。通过允许使用者观察夹具310或插件300的选定部分，对准夹具310可以辅助和/或确保引导器100被定位和配准到髋臼82内。此外，因为插件300以键合的方式接合柱130，所以这至少帮助引导器100的旋转对准。因此，当髋臼引导器100以选定的单一位置和取向配准在髋臼82内时，在使用者的观察下，对准夹具310可以辅助确保引导器100处于预先选择的或预先计划的位置并且相对于预先计划和选择的取向增加对准引导器100的速度。
可以理解的是，引导器100可以相对于在手术过程中能够被使用者观察到和/或触摸导的任何选定的解剖学标记来定向。例如，可以理解的是，中心柱130可被设计和定位在引导器100内，使得当引导器100被正确配准在髋臼82内时柱对准轴线130a与髂嵴420对准。因此，如果将引导器100的预先计划或预先确定的取向选择成使轴线130A与不同的标记对准，则不需要使柱对准轴线130a与ASIS 400对准以确保引导器100与患者正确地配准。
然而，基于与所选标记的预先计划或预定的对准，插件300可以用于在引导器100插入和放置到髋臼82内的过程中使引导器100相对于髋臼82旋转。一旦被正确地配准，插件300可被从中心柱130移除，并且可以使对准销230穿过已经定位在配准引导器120内的钻插件122，如图4所示。当使对准销230插入穿过已经定位在配准引导器120内的钻插件122时，对准销230总体上沿着相对于引导器100预先设计的对准轴线A延伸。此外，通过定位引导器100使其配准到髋臼82内，对准轴线A处于相对于髋臼82的预先计划和选择的位置。定位对准销230使其穿过被定位在对准引导器120内的钻插件122并且使其钻入骨盆80内使定位销230沿着轴线A定位。
如上所述，通过使插件300相对于中心柱130定位以沿着中心柱130的柱对准轴线130a对准对准夹具310或手柄300的其他选定部分来实现引导器100的定位。因此，通过下述引导器100可被相对于患者正确配准：至少通过手柄300和引导器100(因为其与手柄300联接)的旋转，相对于诸如ASIS 400的选定解剖学标记与对准夹具300对准。以这种方式，插件300可以用于从旋转的角度定位引导器100，以将对准轴线A置于预定的位置和取向，用于放置销230。
一旦对准销230被定位在骨盆80内，通常钻孔插件122可被沿着对准销230移除，并且引导器100可被相对于对准销230纵向地和/或侧向地移除。然后，对准销230可被直接地或间接地用于引导手术的各个部分，例如髋臼82的扩孔和/或定位髋臼植入物250，如图5所示。通过使具有中心轴线A'的髋臼植入物250与对准销230对准，髋臼植入物250可以以对准轴线A为基准而定位在髋臼中。因此，如图5所示，可以与已经相对于骨盆80预先进行计划和确定的对准轴线A对准地定位髋臼植入物250。
在不同实施例中，销230可以与引导器100和钻插件122一起定位在选定位置(例如患者特定位置)，并且被保持在该选定位置以进行手术的剩余部分。然而，在不同的实施例中，可以将销230移除，而钻插件或引导器122可以在整个手术或手术的剩余部分中保持在解剖结构中。此外，如本文所讨论的，可以将第一钻插件放置在销230上，并将第二钻插件或引导器放置在第二位置处。可以在手术的剩余部分中使第二钻插件或引导器保持在解剖结构中，但移除引导器100和第一钻插件122。
因此，附加地或替代地，对准销230可以在选定的过程(例如髋臼82的扩孔)期间被选择性地移除。如图8所示，钻插件122包括设置在远侧部分129上的骨接合翅部127a。(请注意，钻插件122可以可选地包括自攻螺纹127b或其他合适的防退出特征)。如上所述，外科医生可以使用诸如驱动器500的工具将钻插件122驱动到髋臼82处或附近的骨头内。
如上所述，翅部127a、或者可选的螺纹127b防止钻插件122从骨中退出。因此，对准销230可被选择性地沿着轴线A移除而不会失去对准轴线A的基准。换言之，在对准销230已经移除后，钻插件122保持留在骨内并且提供对轴线A的参考。根据外科医生的需要或期望通过移除对准销230，外科医生可以扩孔或执行其他操作过程，而不受对准销230的阻碍。
在又一实施例中，对准销230可被移除并且组装在位于髋臼82附近的骨预定区域处的替代钻插件122中，但是在与由被连接到引导器100的钻插件122限定的位置不同的位置。如图9所示，联接机构600可以将对准销230联接到驱动器500。
对准销230可以根据上述方法中任一个组装到第一钻插件122。在一些情况下，外科医生可能需要无障碍的工作空间来对髋臼82进行扩孔或执行其他手术过程。因此，外科医生可以如上所述从第一钻插件122移除对准销230。附加地或替代地，外科医生可以将对准销230重新定位到一术前定义的位置以便继续引导过程的各个部分，诸如对髋臼82的扩孔和/或定位髋臼植入物250。
联接机构600可以形成为可松开地联接两个或更多个构件，包括销230。因此，联接机构可以包括构造成接收轴508的一部分的第一开口604和构造成接收对准销230的一部分的、距第一开口604一被选定和被形成的距离610的第二开口608。距离610可以在术前计划期间确定。例如，可以选择驱动器500与对准销230之间的距离610，以如下面将详细描述的那样将对准销230重新定位在相对于髋臼82的预定位置处。因此，联接机构也可以是患者特定联接机构600。
驱动器500被配置为驱动第二钻插件122a，例如上面描述的那些。通过联接机构600，对准销230用作于放置第二钻插件122a的引导器。接着，外科医生通过联接机构600、例如利用推动、击打或转动的方式来围绕着轴线A驱动驱动器500，直到选择了合适的和/或预定的骨区域。因此，引导器100和第一钻插件122可以用于放置销230。在销230的定位之后，第二钻插件122a可被放置在与第一钻插件122的位置不同的第二位置处。
例如，可以在计划期间预定和/或选择第二位置650。第二位置可以由距离610和/或相对于解剖结构的选定取向来定义，比如与PSIS或ASIS对准。因此，一旦驱动器500经由联接机构600联接到销230，其就可以与选定的解剖结构或其他部分对准，以便沿着轴线B与第二位置650对准。接着，可以使用驱动器500来将第二钻插件122a放置在第二位置650处。
如图10所示，外科医生将第二钻插件122a驱动到骨内，如上所述。应该注意的是，第二钻插件122a可以包括翅部127a，螺纹127b或设置在远侧部分129上的任何其他防退出特征。然后，外科医生可以将驱动器500从第二钻插件122a移除，如图11A所示。
另外参考图11B，外科医生可以将对准销230从第一钻插件122移除并且将对准销230组装到第二钻插件122a中。以这种方式，在手术过程期间，例如在对髋臼82扩孔时，可以移除对准销230以避免妨碍。此外，根据预定的计划，例如基于患者图像，对准销230可以在组装在第二钻插件122a中时直接或间接地提供引导。如果被选定，则外科医生可以将对准销230从第二钻插件122a移除并将对准销230重新组装到第一钻插件122中。因此可以理解的是，这些钻插件可以定位成用于接收由外科医生选定的销230
此外，根据需要销230也可被移除并重新组装到第二钻引导器122a中。因此，钻引导器122可与引导器100分离开地固定在骨中，以允许保留用于放置销230的位置，而与销230的重复移除和重新放置无关。而且，可以理解的是，销230可以限定引导轴线，例如用于扩孔或植入物放置，而与其放置在何处无关。因此，如上所述，销230不需要位于附接到引导器100的钻插件122中来提供引导轴线，用于执行过程的各部分。
此外，可以选择的是，穿过被附接到引导器100的钻插件122限定的轴线A可能永远不会被选择用于执行对髋臼的改变，例如扩孔或植入物放置，而是轴线A可以仅仅被定义用来引导第二钻插件122a的放置，用于限定轴线B以辅助该过程。因此，以如上面关于轴线A所述的类似的方式，轴线B也可以由使用者(例如外科医生)使用。
可以理解的是，患者特定引导器100可被定位在患者的髋臼82内预先计划和配准的位置处。患者特定引导器100的定位可能需要轴向移动到髋臼82和/或在髋臼82内轴向移动并且在髋臼82内旋转地定位。插件300可以相对于中心柱130联接，中心柱130在预先计划和选定的位置处固定到髋臼引导器100，使得柱130的柱对准轴线130a可以与预定标记对准。包括对准夹具310或其他适当的对准部分的插件300可以与中心柱130的柱对准轴线130a对准以供使用者观察。在将导向器100插入髋臼82期间使用者看到对准轴线和/或对准夹具310可以允许使用者通过将对准夹具310与预定标记、比如ASIS 410对准来确保导向器100在髋臼82内的正确定位。因此，以键合的方式以预定取向相对于引导器100联接的插件300可用于辅助将患者特定引导器100确保放置在髋臼82内。
根据各种实施例，当引导器100被放置在髋臼82内的预定位置和取向中时，引导器100被配准到髋臼82。通常，由于外表面104与髋臼单独接触或利用对准钩110的各部门和/或表面128接触，发生和/或实现上述配准。因此，引导器100可以以特定的和预定的位置和取向配准到特定患者的髋臼82。
各种患者特定引导器、辅助引导器、扩孔器、引导手柄、插件、冲击器、支撑装置、电子定位器和其他仪器可以以各种组合使用，并且可以基于外科医生的喜好或患者以及术前或术中情况使用，用于准备髋臼并沿着术前确定的对准取向引导和植入髋臼植入物。在这方面，提供冗余功能和不同实施例的工具和仪器可以以套件或根据外科医生的请求提供给外科医生。
例如，在本文所述的方法的范围内，上述的适配器和其他仪器可以各种组合提供和使用。
前面的讨论仅仅公开和描述了本教导的示例性布置。此外，在本文中明确地设想了各种实施例之间的特征、元件和/或功能的混合和匹配，以使得本领域的普通技术人员从本公开中能够意识到一个实施例的特征、元件和/或功能可以并入另一实施例内，除非另有说明。而且，在不偏离本发明的实质范围的情况下，可以做出许多修改以使特定的情况或材料适应于本教导。本领域的技术人员从此讨论中以及从附图和权利要求中很容易地认识到，在不偏离如所附权利要求限定的本教导的实质和范围的情况下，可以进行各种改变，修改和变化。

Claims (22)

1.一种用于将引导销放置在髋臼附近的髋臼引导系统，包括：
患者特定髋臼引导器，其包括内表面和外表面，所述外表面被构造成具有配准到特定患者的髋臼内的几何结构；
第一钻插件，所述第一钻插件被配置为在第一位置处由所述患者特定髋臼引导器接收，所述第一钻插件具有第一纵向孔，所述第一纵向孔被构造成同心地接收在所述患者特定髋臼引导器的引导孔中，所述引导孔延伸至所述内表面外面；
第二钻插件，所述第二钻插件被配置为在距所述第一位置预定距离的第二位置处固定到位于所述髋臼外面的骨部分，所述第二钻插件形成第二纵向孔；以及
可选择性移除的对准销，所述对准销被配置为由所述第一纵向孔和所述第二纵向孔中的至少一个接收。
2.根据权利要求1所述的髋臼引导系统，其中所述第二钻插件包括近侧部分和远侧部分，所述远侧部分包括至少一个防退出特征。
3.根据权利要求2所述的髋臼引导器，其中所述至少一个防退出特征包括从所述远侧部分的外表面延伸的螺纹和翼部中的至少一个。
4.根据权利要求2所述的髋臼引导器，其中所述近侧部分能够被驱动器接合，所述驱动器被配置用于旋转所述近侧部分，由此将所述远侧部分驱动到所述位于髋臼外面的骨部分中。
5.根据权利要求4所述的髋臼引导系统，还包括被配置成将所述对准销联接到所述驱动器的联接机构。
6.根据权利要求5所述的髋臼引导系统，其中经由所述联接机构所述驱动器被围绕着所述对准销旋转至相对于所述髋臼的预定位置。
7.根据权利要求6所述的髋臼引导系统，其中在与所述预定位置相关的第二位置处所述驱动器将所述第二钻插件驱动到骨内。
8.根据权利要求7所述的髋臼引导系统，其中所述对准销被配置为从所述第一钻插件选择性地移除并组装到所述第二钻插件。
9.一种利用髋臼引导系统将引导销放置在髋臼附近的方法，包括：
提供患者特定髋臼引导器，包括将所述患者特定髋臼引导器的外表面形成为具有配准到特定患者的髋臼内的几何结构；
提供第一钻插件，所述第一钻插件具有第一纵向孔，所述第一纵向孔被构造成同心地接收在所述患者特定髋臼引导器的引导孔中，所述引导孔延伸到所述患者特定髋臼引导器的内表面外面，以在第一位置处对准所述第一钻插件；
提供第二钻插件，所述第二钻插件具有第二纵向孔并且被配置为在距所述第一位置预定距离的第二位置处固定到骨头部分；以及
提供可选择性移除的对准销，所述对准销被配置为由所述第一纵向孔或所述第二纵向孔中的至少一个接收。
10.根据权利要求9所述的方法，其中将所述患者特定髋臼引导器的外表面形成为被构造成具有配准到特定患者的髋臼内的几何结构包括获取所述特定患者的图像和将所述患者特定髋臼引导器的外表面设计为具有与所述特定患者的髋臼相配合的配合表面。
11.根据权利要求9或权利要求10所述的方法，其中提供所述第二钻插件包括提供近侧部分和在远侧部分上提供至少一个防退出特征。
12.根据权利要求11所述的方法，还包括接合所述近侧部分以便在所述第二位置处将所述远侧部分驱动到位于骨部分内，以及将所述对准销组装到所述第二钻插件中。
13.根据权利要求12所述的方法，还包括在将所述第二钻插件保持于所述骨部分中的同时从所述第二钻插件选择性地移除所述对准销。
14.根据权利要求11-13中任一项所述的方法，还包括将所述对准销联接到驱动器，所述驱动器被配置为在距所述第一位置预定距离的第二位置处将所述第二钻插件驱动到所述骨部分内。
15.根据权利要求14所述的方法，还包括在所述第二位置处通过所述驱动器将所述第二钻插件驱动到所述骨部分中。
16.根据权利要求15所述的方法，还包括从所述第一钻插件选择性地移除所述对准销并将所述对准销定位到所述第二钻插件中。
17.一种植入髋臼植入物的方法，包括：
形成患者特定髋臼引导器，所述患者特定髋臼引导器具有外表面，所述外表面具有被形成为配准到特定患者的髋臼内的几何结构；
在相对于所述髋臼的第一位置处将第一钻插件连接到所述患者特定髋臼引导器，所述第一钻插件具有第一纵向孔，所述第一纵向孔被构造成同心地接收在所述患者特定髋臼引导器的引导孔中，所述引导孔延伸到所述内表面外面，以在第一位置处对准所述第一钻插件；
在所述第一位置处将对准销固定到骨的第一部分，所述对准销由所述第一纵向孔接收；
移除患者特定髋臼引导器和第一钻插件；
将驱动器联接到对准销；
在第二位置处利用所述驱动器将具有第二纵向孔的第二钻插件驱动到骨的第二部分内，所述第二位置距所述第一位置预定距离；并且
从第一钻插件选择性地移除对准销。
18.根据权利要求17所述的方法，还包括在所述第二位置处将所述对准销固定到所述骨的第二部分，所述对准销由所述第二纵向孔接收。
19.根据权利要求18所述的方法，还包括从所述第二钻插件选择性地移除所述对准销。
20.根据权利要求19所述的方法，还包括在从所述第一钻插件移除所述对准销之后对所述髋臼进行扩孔。
21.根据权利要求20所述的方法，还包括在对所述髋臼进行扩孔之后插入所述对准销使其穿过所述第二钻插件的所述第二纵向孔。
22.根据权利要求21所述的方法，还包括基于由所述对准销限定的轴线将髋臼植入物植入到被扩孔的髋臼中。
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US20160287408A1 (en) 2016-10-06
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