CN106456193A - 肱骨切割引导件 - Google Patents
肱骨切割引导件 Download PDFInfo
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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
- A61B17/14—Surgical saws ; Accessories therefor
- A61B17/15—Guides therefor
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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
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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
- A61B17/175—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hip for preparing the femur for hip prosthesis insertion
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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
- A61B17/1778—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the shoulder
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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
- A61B17/56—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
Abstract
用于切除或表面置换肱头的肱骨切割引导系统。肱骨切割引导系统包括被配置为可拆除地接合到肱头的主切割引导构件。所述主切割引导构件包括患者特异性骨接合表面，限定出主切割面的主细长槽，以及被配置用于接收一对引导销针的一对圆柱形孔隙。辅助切割引导构件包括被配置为与所述一对引导销针配合的一对通孔，并且所述辅助切割引导构件包括限定出辅助切割面的辅助细长槽。
Description
技术领域
本发明涉及肱骨切割引导构件。
背景技术
本部分提供与本发明相关的背景信息，但不必然是现有技术。
在肩部关节形成术中，上膊骨(humeral bone)可能需要表面置换或切除以接收肩关节植入体。手术之前，医生通常会通过X射线、CT、超声、MRI、或PET提取包括上膊骨的手术区域的多个图像。基于这些图像，医生能够确定对于表面置换或切除上膊骨的最佳行动方案，以及确定用于肩部修复的主手术过程是解剖还是反向关节置换术(anatomical orreverse arthroplasty)。然而，在手术过程中，比较常见的情况是医生确定预先选择的行动方案不适合该患者。如果在手术过程中改变行动方案，那么在结束关节置换之前可能需要新的器械正确地完成上膊骨的表面置换或切除。
发明内容
本部分提供本公开的总体概要，不是其完整范围的全面公开或不是所有其特征。
本公开提供了一种用于切除或表面置换肱头的肱骨切割引导系统。该切割引导系统包括被配置为可拆除地接合到肱头的主切割引导构件。所述主切割引导构件包括患者特异性骨接合表面，限定出主切割面的主细长槽，以及被配置用于接收一对引导销针的一对圆柱形孔隙。该切割引导系统还包括辅助切割引导构件，其包括被配置为与所述一对引导销针配合的一对通孔，其中所述辅助切割引导构件包括限定出辅助切割面的辅助细长槽。
本公开还提供了一种切除或表面置换肱头的方法。该方法包括将主切割引导构件附连到肱头。所述主切割引导构件包括患者特异性骨接合表面，限定出主切割面的主细长槽，以及一对圆柱形孔隙。该方法还包括确定所述主切割面对于肱头的切除或表面置换来说是否足够。如果所述主切割面足够，则进行肱头的切除或表面置换。如果所述主切割面对于肱头的切除或表面置换来说不足够，则使一对引导销针穿过所述圆柱形孔隙接合到肱头，除去主切割引导槽，并且将辅助切割引导构件附接到销针，所述辅助切割引导构件包括限定出辅助切割面的辅助细长槽。
其它应用性领域将从在下面提供的描述中变得显然。本发明内容中的描述和特殊示例仅用于示意目的而不意于限制本公开的范围。
附图说明
这里描述的附图仅用于所选实施例的示意目的，不是所有可能的实施方式，并且不意于限制本公开的范围。
图1是用于反向肩关节置换术的现有技术植入体的分解图；
图2是图1的现有技术植入体的环境视图；
图3是根据本公开的原理的肱骨切割引导系统的立体环境视图；
图4是根据本公开的原理的肱骨切割引导构件的立体环境视图；
图5是图3中示出的肱骨切割引导件的外部的立体图；
图6是图3中示出的肱骨切割引导件的内部的另一立体图；
图7是根据本公开的原理的辅助切割引导件的立体图；
图8是图4中示出的销针的立体环境视图，其中图4中的肱骨切割引导件被去除；
图9是图7中示出的辅助切割引导件被安装到图8中示出的销针的立体环境视图；
图10是根据本公开的原理的肱骨切割引导系统的立体环境视图；
图11是图10中示出的肱骨切割引导系统的另一立体环境视图；
图12是形成图10中示出的肱骨切割引导系统的一部分的肱骨配合构件的立体环境视图；
图13是形成图10中示出的肱骨切割引导系统的一部分的肱骨切割引导构件的立体图；
图14是图12中示出的肱骨配合构件的立体图；
图15是根据本公开的原理的另一肱骨切割引导系统的立体环境视图；
图16是图15中示出的肱骨切割引导系统的另一立体环境视图；
图17是图15中示出的肱骨切割引导构件的立体图；和
图18是图15中示出的肱骨切割引导构件的另一立体图。
贯穿若干附图，对应的参考数字表示对应的零件。
具体实施方式
现在参考附图更完整地描述示例性实施例。
本公开总体上提供一种患者特异性手术器械，例如，包括对准引导件，钻削引导件，以及在肩关节置换术、肩表面置换术和其它手术中使用的其它工具，所述其它手术过程是与肩关节或肩关节的各骨头、包括肱头相关的手术。本公开可应用于解剖肩关节置换和反向肩关节置换或表面置换。本患者特异性器械可与传统的植入部件一起使用，或与使用根据本公开的计算机辅助图像方法制备的患者特异性植入部件和/或骨植物一起使用。利用对患者解剖学结构的医学扫描(比如MRI、CT、超声、X射线、PET等)进行计算机建模而获得患者解剖学结构三维图像，患者特异性假体部件和患者特异性引导件，模板和其它器械，可利用各种商业上可获得的CAD程序和/或例如通过加拿大蒙特利尔的Object ResearchSystem或ORS的软件制备。
患者特异性器械和任何相关的患者特异性植入体和骨植物总体上可以根据对从医学图像扫描产生的患者3-D解剖学结构图像进行的计算机建模而设计和制造，所述医学图像扫描包括，例如，X射线、MRI、CT、PET、超声或其它医学扫描。这些患者特异性器械可具有三维接合表面，所述三维接合表面是与具有或不具有相关联的软组织的三维骨表面互补的并且被制造成在仅一个位置上与其大体配合和匹配(即，作为大致负向或镜像或反向表面)，所述具有或不具有相关联的软组织的三维骨表面被通过前述CAD或软件重新构造为3-D图像。非常小的不规则性不需要引入三维接合表面中。患者特异性器械可以包括定制性引导结构，比如，引导孔或空心引导柱或空心引导延伸部或插口，它们可用于支撑或引导其它器械，比如钻削引导件、铰孔器、切割器、切割引导件和切割块，或用于插入引导销针、K-线、或根据医生批准的术前规划的其它紧固件。
在不同实施例中，本公开的患者特异性器械可还包括一个或多个患者特异性引导构件，用于在相应的患者特异性插入点处接收和引导工具，比如钻或锯或导丝，并且用于相对于特定患者的被选解剖学结构或反向轴线进行定向。患者特异性器械可包括用于引导与手术过程相关的患者特异性植入体或现成的植入体的植入的引导或定向结构和特征。患者特异性器械以及可能存在的各种患者特异性植入体和骨植物的各特征的几何形态、形状和定向可以在该手术过程的术前规划阶段期间、与患者解剖学结构的计算机辅助建模相关地进行确定。在术前规划阶段期间，可对患者特异性器械、定制的、半定制的或非定制的植入体和其它非定制工具进行选择，并且可利用来自医生或与手术过程相关的其它工作人员的输入制造用于特异性患者的患者特异性部件。
在下面的讨论中，术语“患者特异性”、“定制”或“定制的”被限定为应用到包括工具、植入体、它们的某些部分或组合的部件，其包括特定的几何特征，包括表面、曲线、或其它线，并且被制成为实质上密切符合患者解剖学结构的相应几何特征或解剖标志的镜像图像或负向或互补表面，所述几何特征或解剖标志是在术前规划阶段期间、基于通过计算机成像方法从对患者的图像扫描重新构造的对应解剖学结构的3-D计算机图像获得或收集的。此外，患者特异性引导特征，比如引导孔隙、引导槽、引导构件或被包括在对准引导件、钻削引导件、切割引导件、粗锉(rasps)或其它器械或植入体中的其它孔或开口，被定义为具有位置、定向、尺寸、形状和/或定义对于特殊患者的解剖学结构来说特定的切割面和轴线的特征，包括基于与患者有关的计算机辅助术前规划的各解剖学或机械轴线。
患者特异性引导构件可被配置为，通过在手术期间将对应对准引导件定向和放置在骨头上面以与对应标记配合，而与天然解剖学结构的标记对准地配合。所述解剖学标记用作用于定位各种对准引导构件、钻削引导件或其它患者特异性器械的被动基准标识或基准标识。
各种患者特异性对准引导构件可由任何生物相容性材料制成，包括聚合物、陶瓷、金属或其组合物。患者特异性对准引导构件可以是一次性的并且可与可重复使用的并且是非患者特异性的切割和引导部件相结合或一起使用。
更具体地，本公开提供用于解剖和反向关节置换术的患者特异性肱骨切割引导构件的多种实施例。本公开的肱骨切割引导件可具有参照肩关节的各部分的患者特异性接合表面，并且包括管状钻削引导件、引导孔或套管或能够精确地定位引导销针用于后面的肱骨制备和植入手术过程并且用于对准目的其它引导结构，包括用于解剖学和反向关节置换术两者的植入位置控制、植入形式控制、植入倾斜控制。
下面，在肱骨引导构件的一部分被描述为“参照”解剖学结构的一部分时，应理解肱骨引导构件的该参照部分是镜像该对应解剖学部分并且是作为负向部分的患者特异性部分。
在一些实施例中，肱骨引导构件可具有内置孔、开口或窗口，允许医生用打标记笔、磨石、手术刀、或能够在上膊骨或肱骨模型上或中制造用作记号的标记的任何其它装置来标记肱骨或上膊骨模型。这些标记可用于辅助引导件的定向。
参考图1和2，示出了现有技术的反向肩关节植入体10。反向肩关节植入体10包括肱骨柄12，肱骨托盘14，肱骨支承件16，盂关节球部(glenosphere)18和具有板部分22和中心凸起24的基板20。肱骨柄12被植入上膊骨26中，并且具有经由莫氏(Morse)锥形连接部耦合到公锥形部30的近端28，公锥形部30从肱骨托盘14的板32延伸。盂关节球部18可以是模块式的并且包括与支承件16关节连接的头部34和偏置双锥形部部件36。双锥形部部件36具有被接合到头部34的对应锥形开口40的第一锥形部分38和被接合到关节窝基板20的中心凸起24的第二锥形部分42。中心螺钉44穿过基板20进入患者肩胛骨的关节面46。外围螺钉48被用于将基板20锁定在关节面46中。
如图2中最佳示出的，上膊骨26必须包括用于与肱骨托盘14的板32抵接的平面50。为了提供平面50，上膊骨26必须首先使用比如骨锯(未示出)的工具进行切割。为了使该锯以正确的角度相对于上膊骨26进行定向，本公开提供了肱骨切割引导系统52。
参考图3-9，示出了根据本公开的一方面的示例性肱骨切割引导系统52。肱骨切割引导系统52包括患者特异性主切割引导构件54和辅助切割引导构件56。主切割引导构件54被配置为患者特异性的，使主引导构件54与上膊骨26相配合。在这一点上，主切割引导构件54包括内或骨接合表面58，其是与带有或不带有相关联软组织的上膊骨26的三维骨表面60互补的并且被制成为在仅一个位置与其实质上配合和匹配(即，作为大致负向或镜像或反向表面)，该三维骨表面被通过前述CAD或软件重新构造为3-D图像。
主切割引导构件54的外表面62被大致成形为饼状并且包括一对孔隙64。孔隙64为医生提供看穿到上膊骨26的视线。另外，孔隙64减少形成主切割引导件54所需的材料的量。然而，应理解，在不偏离本公开的范围的情况下主切割引导构件54可被形成为没有孔隙64。不管怎样，如果主切割引导构件54被提供有孔隙64，那么会有肋65在孔隙64之间延伸并且包括从其伸出的突出部66。突出部66提供弯曲的接触表面68，以允许肱骨引导构件54被医生操作至与上膊骨26正确对准。换句话说，医生可将指尖放在接触表面68上，允许医生更容易定向主切割引导构件54，使骨接合表面58与上膊骨26的骨表面60正确对准。不论主切割引导构件54是否包括孔隙64，主切割引导构件54都可包括突出部66。
主切割引导构件54可包括限定出患者特异性销针引导孔隙72的远端70。销针引导孔隙72被按照特定患者对准并且允许钻、施氏针或导丝(未示出)通过，以允许在适当位置处铰削上膊骨26，以用于上膊骨26的任何预期表面置换。另外，销针引导孔隙72允许上膊骨26用铰削装置(未示出)进行铰削，用于无柄假体切除术，如果需要。
主切割引导构件54的近端74限定患者特异性主细长槽76。主细长槽76用于接收来自切割工具、比如骨锯(未示出)的刀片，比如允许上膊骨26进行表面置换或切除以提供平面50。主细长槽76形成在从外表面62向外延伸的隔板78中。隔板78包括上表面80和相反的下表面82。隔板78沿着近端74的基本上整个长度延伸。通过提供隔板78上的主细长槽76而不是简单地在外表面62上形成主细长槽76，工具刀片被实质上防止了在上膊骨26的表面置换而形成平面50的过程中被不正确地倾斜。
主切割引导构件54可包括从隔板78向外延伸的凸耳83(图6)。凸耳83包括背离上膊骨26的外表面84，和面对着上膊骨26的内表面85。类似于骨接合表面58，凸耳83的内表面85被配置为患者特异性的，使内表面85与上膊骨26配合。特别是，包括内表面85的凸耳83被配置为安置在上膊骨26的肱二头肌沟中并且与其相配合。因此，当主切割引导构件54与上膊骨26配合时，凸耳83可用作用于主切割引导构件54的对准装置。
一旦医生已经将主引导构件54正确地附连到上膊骨26，医生就可以确定是否要切除上膊骨26了。也就是说，在进行肩关节置换术之前，医生进行主手术过程和辅助手术过程的规划。例如，主手术过程可以是切除上膊骨26用于反向肩关节植入体10。可选地，辅助手术过程可以是切除上膊骨26用于解剖学肩植入体(未示出)，这需要切除上膊骨26的不同部分。不管怎样，医生在已经附连了用于进行主手术过程的主切割引导构件54之后，医生可能确定该主手术过程对于该患者来说不适合。相比之下，医生可以确定辅助手术过程是否更有益于患者。不管选择哪个手术过程，主切割引导构件54都允许根据需要实施主和辅助手术过程。
更具体地，除包括细长槽76之外，主切割引导构件54包括一对患者特异性管状引导孔隙86。管状引导孔隙86可被定位成靠近隔板78的相反两端，并且允许钻通过来铰削上膊骨26。在铰削上膊骨26之后，一对销针88可被植入上膊骨26中。例如，销针88可以是施氏针或K-线。然而，本领域内的技术人员已知的任何类型的销针可被植入。
在植入销针88之后，主切割引导构件54可被从上膊骨26除去，而销针88留在该位置。然后，辅助切割引导构件56可与销针88配合。辅助切割引导构件56是大致成形为平行六面体的构件，包括第一、第二、第三、和第四主表面90，92，94，和96。侧表面98可形成在切割引导构件56的相反两端上。连接每一个主表面90-96以及将主表面90-96连接到侧表面98的拐角可以是弯曲的或被斜切的，如图7中最佳示出的。
一对通孔99在第二和第四主表面92和96之间延伸用于接收销针88。另外，辅助细长槽100可在第二和第四主表面92和96之间延伸。虽然仅示出了单一辅助槽100，但应理解辅助切割引导构件56可包括多个辅助细长槽100。提供多个辅助细长槽100允许切割引导构件56可重复使用，并且允许医生选择适当的辅助细长槽100来切除上膊骨26。辅助细长槽100可形成在通孔99的任一侧，没有限制。一旦辅助切割引导构件56与销针88相配合，则可以根据需要使用所选辅助细长槽100作为切割工具、比如骨锯的引导件而对上膊骨26进行表面置换。应理解，如果在手术期间医生确定应使用在由主细长槽76提供的切割高度之外的不同切割高度，则可以使用辅助细长槽100。还应理解销针88不必须相对于上膊骨26定向以提供不同切割高度。相比之下，在销针88与上膊骨26配合并且辅助切割引导构件56被接合到销针88时，则引导孔隙86可包括提供不同(即，不平行)切割面的定向。
根据上述实施例，肱骨切割引导系统52允许多个切割高度和平面被执行肱骨表面置换术的医生选择。因为主切割引导构件54是患者特异性的并且包括主细长槽76以及管状引导孔隙86，所以主切割引导构件54可为患者制备用于在手术前确定的主和辅助手术过程的每一个。
现在参考图10至14，示出了另一示例性肱骨切割引导系统200。肱骨切割引导系统200包括包含肱骨配合构件202和肱骨切割引导构件204的主切割引导构件。肱骨配合构件202包括多个抓握构件206。在图示实施例中，肱骨配合构件202包括从中心毂214向外延伸的三个抓握构件208，210和212。然而，应理解，在不偏离本公开的范围的情况下任何数目的抓握构件206可被使用。
每一个抓握构件206包括被固定到中心毂214的近端216和远离中心毂214定位的远端218。中心毂214和抓握构件206分别包括内或骨接合表面217以及背离上膊骨26的外表面219。类似于肱骨切割引导系统52，骨接合表面217是与带有或不带有相关联软组织的上膊骨26的三维骨表面60互补的并且被制成为在仅一个位置与其实质上配合和匹配(即，作为大致负向或镜像或反向表面)，该三维骨表面被通过前述CAD或软件重新构造为3-D图像。
抓握构件206可设计为尺寸不同。在图示实施例中，例如，抓握构件208和210具有大致相同的尺寸，而抓握构件212比抓握构件208和210宽。然而，抓握构件212的长度小于抓握构件208和210的长度。不管怎样，抓握构件212提供与上膊骨26更大的接触量，帮助将肱骨配合构件202定位在上膊骨26上。由于抓握构件208和210具有比抓握构件212大的长度，所以抓握构件208和210可包括与上膊骨26的不同突出部配合的患者特异性钩部215。
中心毂214可以椭圆形的并且包括平面外表面220。中心毂214可包括具有不同深度和轨迹的一对凹槽222和224。例如，凹槽222可具有比凹槽224大的深度。凹槽222和224的不同深度使得肱骨配合构件202可在解剖肩关节置换术或反向肩关节置换术中的每一个中使用。也就是说，深度较大的凹槽222可用于解剖肩关节置换术，而深度较浅的凹槽224可用于反向肩关节置换术。然而，应理解，深度较大的凹槽222可用于反向肩关节置换术，深度较小的凹槽224可用于解剖肩关节置换术，如医生在术前确定的。而且，应理解凹槽222和224不必须平行布置。也就是说，凹槽222可相对于凹槽224倾斜，或反之。不管怎样，凹槽222和224可根据患者特异性术前规划以预期的方式定向。
凹槽222和224被设计为与肱骨切割引导构件204配合。如在图13中最佳示出的，肱骨切割引导构件204包括引导臂226和附接臂228。引导臂226和附接臂228被示出为是整体，但在不偏离本公开的范围的情况下也可以单独形成并且进行附接。引导臂226包括通过侧面232连接的外表面228和相反的内表面230。患者特异性主细长槽234在外表面228和内表面230之间延伸用于接收例如对上膊骨26进行表面置换的骨锯的切割刀片。虽然仅示出了单一主细长槽234，但应理解可提供多个细长槽234，以为医生提供不同的切割面来为患者选择，用于在手术期间调整切割高度。引导臂226可包括通孔236。通孔236为医生提供确保肱骨切割引导构件204被相对于上膊骨26正确对准的视线。
附接臂228从引导臂226大致正交向外延伸，并且包括被附接到引导臂226的近端238以及远侧自由端240。附接臂228包括平面上表面242和平面下表面244，平面上和下表面242和244通过侧表面246连接。细长孔隙248在平面上和下表面242和244之间延伸。类似于通孔236，细长孔隙248为医生提供确保肱骨切割引导构件204相对于上膊骨26正确对准的视线。
突伸部250在远侧自由端240处从平面下表面244向外延伸。突伸部250被设计尺寸为与凹槽222或凹槽224配合，取决于正在进行的解剖学或反向肩关节置换术。因为这些手术过程在不同的切割面上进行，所以不同深度的凹槽222和224允许引导臂226的主细长槽234根据所选的凹槽222或224而布置在不同的切割面上。突伸部250还允许切割引导构件204相对于上膊骨26进行枢转。这允许医生在上膊骨26的表面置换或切除开始之前将切割引导构件204定位在上膊骨26的适当位置。可选地，应理解突伸部250和凹槽222和224可被成形为不允许切割引导构件204相对于上膊骨26枢转。相反，因为切割引导系统200是患者特异性的，所以切割引导构件204相对于上膊骨26的正确定向可在肱骨切割引导系统200附接到上膊骨26之前选择。
切割引导构件204可配置为类似于肱骨引导构件54。也就是说，切割引导构件204另外包括允许钻通过以铰削上膊骨26的一对患者特异性圆柱形孔隙252。在铰削上膊骨26之后，一对销针88可被植入上膊骨26中。销针88例如可以是施氏针或K线。然而，本领域内技术人员已知的任何销针可被植入。在植入销针88之后，肱骨配合构件202和切割引导构件204可被从上膊骨26移除，同时销针88保持在位。然后，辅助切割引导构件56可与销针88配合以提供又另一切割面供医生选择。类似于前面描述的实施例，还应理解销针88不必须相对于上膊骨26定向来提供不同切割高度。相比之下，在销针88与上膊骨26配合并且辅助切割引导构件56被接合到销针88时，圆柱形孔隙252可包括提供不同(即，不平行)切割面的定向。
根据上述实施例，肱骨切割引导系统200允许多个切割高度和平面供执行肱骨关节置换术的医生选择。因为肱骨配合构件202是患者特异性的并且包括用于不同手术过程的凹槽222和224，它们被设计为与切割引导构件204配合，肱骨切割引导系统200可为患者制备用于在手术前确定的主和辅助手术过程的每一个(例如解剖学或反向肩关节置换术)。
现在参考图15至18，示出了另一示例性肱骨切割引导系统300。切割引导系统300类似于肱骨切割引导系统200在于切割引导系统300包括包含肱骨配合构件302和肱骨切割引导构件304的主切割引导构件。然而，在本实施例中，肱骨配合构件302和肱骨切割引导构件304是整体的。肱骨配合构件302包括多个抓握构件306。在图示实施例中，肱骨配合构件302包括从中心毂314向外延伸的两个抓握构件308和310。然而，应理解，在不偏离本公开的范围的情况下可使用任何数目的抓握构件306。
每一个抓握构件306包括被固定到中心毂314的近端316和远离中心毂314定位的远端318。中心毂314和抓握构件306分别包括内或骨接合表面315和背离上膊骨26的外表面317。类似于肱骨切割引导系统52，骨接合表面315是与带有或不带有相关联软组织的上膊骨26的三维骨表面60互补的并且被制成为在仅一个位置与其实质上配合和匹配(即，作为大致负向或镜像或反向表面)，该三维骨表面被通过前述CAD或软件重新构造为3-D图像。在图示实施例中，抓握构件308和310具有大致相同的尺寸。然而，应理解，在不偏离本公开的范围的情况下抓握构件306可被设计为尺寸不同。
中心毂314可包括圆柱形基部部分320。管轴322可从基部部分320向外延伸，限定出患者特异性销针引导孔隙324。销针引导孔隙324允许钻(未示出)通过，允许上膊骨26在适当位置处进行铰削，用于上膊骨26的任何预期表面置换术。另外，销针引导孔隙324允许上膊骨26被铰削，用于干无柄假体切除术，如果需要。
如在图16-18中最佳示出的，肱骨切割引导构件304包括通过侧面332连接的外表面328和相反的内表面330。患者特异性主细长槽334在外表面328和内表面330之间延伸，用于接收例如对上膊骨26进行表面置换的骨锯的切割刀片。虽然只示出了单一主细长槽334，但应理解可提供多个细长槽334，以为医生提供不同的切割面来为患者选择。
切割引导构件304被配置为类似于肱骨引导构件54。也就是说，切割引导构件304另外包括一对患者特异性圆柱形孔隙352，允许钻通过用于铰削上膊骨26。在铰削上膊骨26之后，一对销针88可被植入上膊骨26中。销针88例如可以是施氏针或K线。然而，本领域内技术人员已知的任何类型的销针可被植入。在植入销针88之后，肱骨配合构件302和切割引导构件304可被从上膊骨26移除，同时销针88保持在位。然后辅助切割引导构件56可与销针88配合，以为医生提供又另一切割面供选择。而且，应理解销针88不必须相对于上膊骨26定向来提供不同切割高度。相比之下，在销针88与上膊骨26配合并且辅助切割引导构件56被接合到销针88时，圆柱形孔隙352可包括提供不同(即，不平行)切割面的定向。
根据上述实施例，肱骨切割引导系统300允许多个切割高度和平面供执行肱骨表面置换的医生选择。因为肱骨配合构件302和肱骨切割引导构件304是患者特异性的并且包括患者特异性细长槽322和患者特异性圆柱形孔隙352，所以肱骨切割引导系统300可为患者制备用于在手术之前确定的主和辅助手术过程中的每一个(例如，解剖学或反向肩关节置换术)。
对各实施例进行的前述描述已经被提供用于示意和描述目的。它不意于是排他性的或限制本发明。特殊实施例的单个元件或特征一般不限制于该特殊实施例，而是在使用时是可互换的并且可在所选实施例中使用，即使没有进行特别示出和描述。同样可以多种方式改变。这些变化不能认为是从本发明的偏离并且所有修改被包含在本发明的范围内。
Claims (27)
1.一种用于切除或表面置换肱头的肱骨切割引导系统，包括：
被配置为可拆除地接合到肱头的主切割引导构件，所述主切割引导构件包括患者特异性骨接合表面，和限定出主切割面的主细长槽，并且包括被配置用于接收一对引导销针的一对圆柱形孔隙；和
辅助切割引导构件，其包括被配置为与所述一对引导销针配合的一对通孔，所述辅助切割引导构件包括限定出辅助切割面的辅助细长槽。
2.根据权利要求1所述的肱骨切割引导系统，其中，所述主切割引导构件包括从其外表面延伸的突出部，所述突出部限定出相对于肱头操纵主切割引导构件的接触表面。
3.根据权利要求1所述的肱骨切割引导系统，其中，所述主切割引导构件包括形成于其中的孔隙，其被配置为当将主引导构件接合到肱头时提供至肱头的视线。
4.根据权利要求1所述的肱骨切割引导系统，其中，所述主切割引导构件包括从其外表面突伸的隔板，所述隔板至少部分地限定所述主细长槽。
5.根据权利要求4所述的肱骨切割引导系统，其中，所述圆柱形孔隙被形成在隔板的相反两端上。
6.根据权利要求1所述的肱骨切割引导系统，其中，所述患者特异性骨接合表面与肱头的患者骨表面互补。
7.根据权利要求1所述的肱骨切割引导系统，其中，所述主切割引导构件包括从其伸出的凸耳，所述凸耳被配置为对应于肱头的患者特异性沟槽。
8.根据权利要求1所述的肱骨切割引导系统，其中，所述主切割引导构件包括接合到中心毂的多个抓握构件。
9.根据权利要求8所述的肱骨切割引导系统，其中，所述抓握构件中的每一个包括患者特异性骨接合表面。
10.根据权利要求8所述的肱骨切割引导系统，其中，所述抓握构件中的至少一个包括被配置用于与肱头配合的钩特征。
11.根据权利要求8所述的肱骨切割引导系统，其中，所述抓握构件被设计为尺寸不同。
12.根据权利要求1所述的肱骨切割引导系统，其中，所述主切割引导构件由肱骨配合构件和肱骨切割引导构件组成。
13.根据权利要求12所述的肱骨切割引导系统，其中，所述肱骨切割引导构件被可拆除地附接到肱骨配合构件。
14.根据权利要求1所述的肱骨切割引导系统，其中，所述肱骨切割引导构件和肱骨配合构件是整体。
15.根据权利要求12所述的肱骨切割引导系统，其中，所述肱骨配合构件包括接合到中心毂的多个抓握构件。
16.根据权利要求15所述的肱骨切割引导系统，其中，所述抓握构件中的每一个包括患者特异性骨接合表面。
17.根据权利要求15所述的肱骨切割引导系统，其中，所述抓握构件中的至少一个包括被配置用于与肱头配合的钩特征。
18.根据权利要求15所述的肱骨切割引导系统，其中，所述抓握构件被设计为尺寸不同。
19.一种确定如何切除或表面置换肱头的方法，包括：
确定主切割面对于肱头的切除或表面置换来说是否足够，以使用主切割引导构件，所述主切割引导构件包括患者特异性骨接合表面，和限定出所述主切割面的主细长槽，并且包括一对圆柱形孔隙；
其中，在所述主切割面对于肱头的切除或表面置换来说不足的情况下，确定使用被配置为穿过所述圆柱形孔隙而接合到肱头的一对引导销针，以及包括限定出辅助切割面的辅助细长槽的辅助切割引导构件，所述辅助切割引导构件被配置用于附接到销针。
20.根据权利要求19所述的方法，其中，所述患者特异性骨接合表面以肱头的患者骨表面互补。
21.根据权利要求19所述的方法，其中，所述主切割引导构件包括接合到中心毂的多个抓握构件。
22.根据权利要求21所述的方法，其中，所述抓握构件中的每一个包括患者特异性骨接合表面。
23.根据权利要求19所述的方法，其中，所述主切割引导构件由肱骨配合构件和肱骨切割引导构件组成。
24.根据权利要求23所述的方法，其中，所述肱骨切割引导构件被可拆除地附接到肱骨配合构件。
25.根据权利要求23所述的方法，其中，所述肱骨切割引导构件和肱骨配合构件是整体。
26.根据权利要求23所述的方法，其中，所述肱骨配合构件包括接合到中心毂的多个抓握构件。
27.根据权利要求26所述的方法，其中，所述抓握构件中的每一个包括患者特异性骨接合表面。
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| EP (1) | EP3142570B1 (zh) |
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Also Published As
| Publication number | Publication date |
|---|---|
| EP3142570A1 (en) | 2017-03-22 |
| WO2015175397A1 (en) | 2015-11-19 |
| CN106456193B (zh) | 2020-02-28 |
| US20150320430A1 (en) | 2015-11-12 |
| US9408616B2 (en) | 2016-08-09 |
| EP3142570B1 (en) | 2022-06-29 |
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