CN106974697A - 植入修正髋关节假体的器械组件 - Google Patents

植入修正髋关节假体的器械组件 Download PDF

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Publication number
CN106974697A
CN106974697A CN201710159262.6A CN201710159262A CN106974697A CN 106974697 A CN106974697 A CN 106974697A CN 201710159262 A CN201710159262 A CN 201710159262A CN 106974697 A CN106974697 A CN 106974697A
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China
Prior art keywords
elongation
axis
distal side
pattern
reamer
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Granted
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CN201710159262.6A
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CN106974697B (zh
Inventor
J.E.卡尔
M.A.胡德
R.E.萨特斯韦特
L.G.麦克利里
R.M.弗比
W.穆哈马德
M.J.福廷
D.E.拉舒雷
V.S.格希瓦鲁赫塞
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DePuy Products Inc
DePuy Synthes Products Inc
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DePuy Products Inc
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    • A61B17/164Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans intramedullary
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Abstract

本发明公开了植入修正髋关节假体的器械组件。一种用于在外科手术期间植入整形髋关节假体的外科器械组件,包括型式复制器械和近侧试验器械。所述型式复制器械包括伸长轴,所述伸长轴具有:对齐键,所述对齐键形成于所述伸长轴的远端中,所述对齐键具有纵向轴线;和对齐槽口,所述对齐槽口形成于所述伸长轴的相对的近端中,所述对齐槽口具有与所述对齐键的纵向轴线位于同一假想线上的纵向轴线。所述近侧试验器械包括:第一部件,具有形成于其外表面中的对齐键,所述第一部件具有纵向轴线;和第二部件,其枢转联接至所述第一部件以允许所述第二部件围绕所述第一部件的纵向轴线旋转,所述第二部件包括配置成容纳股骨头试验件的颈杆。

Description

植入修正髋关节假体的器械组件
本申请是申请号为201280028040.6、国际申请日为2012年4月5日的发明名称为“植入修正髋关节假体的器械组件和使用它的整形外科手术”的发明专利申请的分案申请。
相关专利申请的交叉引用
本专利申请根据35 U.S.C §119(e)要求2011年4月6日提交的美国临时专利申请序列号61/472,500的优先权,该临时专利申请全文据此以引用方式并入本文中。
技术领域
本公开整体涉及用于执行整形关节置换手术的整形外科器械,更具体地讲涉及用于执行髋关节置换修正手术的整形外科器械。
背景技术
在患者的一生中,由于例如疾病或创伤的原因,可能需要对患者执行关节置换手术。关节置换手术可能涉及使用植入到患者的骨中的一者中的假体。在髋关节置换手术的情形中,将股骨假体植入到患者的股骨中。这种股骨假体通常包括球形的头部连同伸长的髓内杆,该球形头部承靠患者的髋臼,该髓内杆用于将股骨部件固定到患者的股骨。为将假体固定到患者的股骨,首先对患者的股骨的髓内腔进行手术准备(如扩孔和/或钻孔),使得随后可将股骨假体的髓内杆植入到该髓内腔中。
在执行这种髋关节置换手术的过程中,通常需要使外科医生在选择假体时具有一定程度的灵活性。具体地讲,其中将被植入假体的骨的解剖结构对于不同患者可能有所不同。例如,给定患者的股骨可能相对长或相对短,从而分别要求使用具有相对长或相对短的杆的股骨假体。此外,在某些情况下,例如当需要使用相对长的杆长度时,所述杆必须也是弓形的,以便适形于患者的股骨的解剖结构。
因此,已设计出模块化的假体。顾名思义,模块化假体是以模块形式构成的,因此可选择假体的各个部件来满足给定患者解剖结构的需要。例如,典型的模块化假体包括近侧主体部件,该近侧主体部件能够组装至多个远侧杆部件中的任一者。此种设计允许选择远侧杆部件,并随后将其植入到患者骨中的适形于患者的解剖结构的位置中,同时还允许在一定程度上相对于患者的髋臼对近侧主体部件进行自主定位。
有时,可能需要对患者执行髋关节修正外科手术。在这种髋关节修正外科手术中,通过手术移除先前植入的髋关节假体,并在患者的股骨中植入髋关节置换假体。
发明内容
根据一个方面,在执行髋关节修正手术期间所使用的模块化股骨假体包括近侧主体部件、远侧杆部件和锁定螺栓。
根据另一个方面,可在整形外科手术期间使用起动器扩孔钻来扩大患者的股骨的髓内腔,以植入模块化股骨假体。
根据另一个方面,在使用起动器扩孔钻之后,可使用远侧扩孔钻来扩大患者的股骨的髓内腔。
可将远侧扩孔钻在其使用之后留在患者的股骨的髓内腔中。接着可将近侧试验器械联接到该远侧扩孔钻并执行试验复位,以确认适当的腿部长度、部件取向和偏置。
根据另一个方面,可在扩孔钻位于患者的股骨的髓内腔中时将扩孔钻导引器轴联接到远侧扩孔钻。
根据另一个方面,可使用修整锉刀来锉患者的股骨。
根据又一个方面,可将远侧杆部件联接到杆插入工具,以便于将杆部件植入到患者的股骨的髓内腔中。
根据另一个方面,可使用近侧扩孔钻来对患者的股骨进行扩孔,以便植入近侧主体部件。
根据另一个方面,可将近侧试验器械联接到试验杆插入工具并随后将其固定到所植入的远侧杆部件。
根据另一个方面,可将型式复制器械联接到所植入的远侧杆部件。可使用型式复制器械来调整近侧主体部件的型式,以使其与近侧试验器械的型式相匹配。
根据又一个方面,可使用外科手术夯来初始地接合远侧杆部件和近侧主体部件之间的锥形锁套连接部。
根据另一个方面,可使用稳杆器和扭矩扳手来安装锁定螺栓,以将近侧主体部件锁定至远侧杆部件。
附图说明
尤其参考以下附图进行详细说明,其中:
图1是在执行髋关节修正手术期间使用的模块化股骨假体的近侧主体部件的透视图;
图2是图1所示近侧主体部件的剖视图;
图3是模块化股骨假体的远侧杆部件的正视图,该远侧杆部件用于在执行髋关节修正手术期间连同近侧主体部件使用;
图4是图3所示远侧杆部件的顶部正视图;
图5是沿图3的线5-5截取的沿箭头方向观察的远侧杆部件的剖视图;
图6为更详细地示出远侧杆部件的局部放大剖视图,其中图6是取自图5,如通过圆圈区域所标出的那样;
图7是起动器扩孔钻的正视图,该起动器扩孔钻用于在执行髋关节修正手术期间对患者的股骨进行手术准备;
图8是用于驱动本文所述各种器械的手动手柄;
图9是远侧扩孔钻的正视图,该远侧扩孔钻用于在执行髋关节修正手术期间对患者的股骨进行手术准备;
图10是沿图9的线10-10截取的沿箭头方向观察的远侧扩孔钻的放大剖视图;
图11是延伸工具的透视图,该延伸工具用于在执行髋关节修正手术期间驱动图9和图10所示的远侧扩孔钻;
图12是图11的延伸工具的正视图;
图13是沿图12的线13-13截取的沿箭头方向观察的延伸工具的剖视图;
图14是近侧试验器械的试验轴的透视图,该试验器械用于在执行髋关节修正手术期间执行试验复位;
图15和16是图14所示试验轴的正视图;
图17是沿图15的线17-17截取的沿箭头方向观察的试验轴的剖视图;
图18是近侧试验器械的试验颈杆的顶部正视图,该试验器械用于在执行髋关节修正手术期间执行试验复位,应当注意,该试验颈杆的一部分已被切除,以为更详细地示出试验颈杆的摩擦夹钳;
图19是图18的试验颈杆的正视图;
图20是沿图18的线20-20截取的沿箭头方向观察的试验颈杆的剖视图;
图21是扩孔钻导引器轴的透视图,该扩孔钻导引器轴用于在执行髋关节修正手术期间引导多个器械;
图22是图21的扩孔钻导引器轴的正视图;
图23是沿图22的线23-23截取的沿箭头方向观察的扩孔钻导引器轴的剖视图;
图24是修整锉刀的正视图,该修整锉刀用于在执行髋关节修正手术期间对患者的股骨进行手术准备;
图25是沿图24的线25-25截取的沿箭头方向观察的修整锉刀的剖视图;
图26是杆插入工具的正视图,该杆插入工具用于在执行髋关节修正手术期间以手术方式将远侧杆部件植入到患者的股骨中;
图27是沿图26的线27-27截取的沿箭头方向观察的杆插入工具的剖视图;
图28是锥形件保护套筒的透视图,该锥形件保护套筒用于在执行髋关节修正手术期间保护远侧杆部件的锥形件;
图29是图28所示锥形件保护套筒的放大剖视图;
图30是近侧扩孔钻的透视图,该近侧扩孔钻用于在执行髋关节修正手术期间对患者的股骨进行手术准备;
图31是图30所示近侧扩孔钻的正视图;
图32是沿图31的线32-32截取的沿箭头方向观察的近侧扩孔钻的剖视图;
图33是试验杆插入工具的透视图,该试验杆插入工具用于在执行髋关节修正手术期间安装图14-20所示的近侧试验器械;
图34是试验杆插入工具的侧正视图,为清楚地进行说明,其中以横截面示出该试验杆插入工具的保持承窝;
图35是试验杆插入工具的保持承窝的放大正视图;
图36是在执行髋关节修正手术期间使用的型式复制器械的透视图;
图37是图36的型式复制器械的侧正视图;
图38是图37的沿线38-38截取沿箭头方向观察的型式复制器械的远端的放大剖视图;
图39是图36的沿线39-39截取沿箭头方向观察的型式复制器械的近端的放大剖视图;
图40是在执行髋关节修正手术期间使用的稳杆器的透视图;
图41是图40所示稳杆器的驱动杆的放大透视图;
图42是图40所示稳杆器的侧正视图;
图43是类似于图42的视图,但为清楚地进行说明,其以横截面显示稳杆器的一部分;
图44为示出起动器扩孔钻的局部正视图,该起动器扩孔钻用于在执行髋关节修正手术期间对患者的股骨的髓内腔进行扩孔;
图45为示出延伸工具和远侧扩孔钻的局部正视图,所述延伸工具和远侧扩孔钻用于在执行髋关节修正手术期间对患者的股骨的髓内腔进行扩孔;
图46为示出近侧试验器械的局部正视图,该近侧试验器械在执行髋关节修正手术期间联接到远侧扩孔钻;
图47为示出扩孔钻导引器轴的局部正视图,该扩孔钻导引器轴在执行髋关节修正手术期间联接到远侧扩孔钻;
图48和49为示出修整锉刀的局部正视图,该修整锉刀用于在执行髋关节修正手术期间锉患者的股骨;
图50为示出远侧杆部件的局部正视图,该远侧杆部件在执行髋关节修正手术期间联接到杆插入工具;
图51为示出杆插入工具的局部正视图,该杆插入工具用于在执行髋关节修正手术期间将远侧杆部件插入到患者的股骨的髓内腔中;
图52为示出扩孔钻导引器轴的局部正视图,该扩孔钻导引器轴在执行髋关节修正手术期间固定到远侧杆部件;
图53为示出近侧扩孔钻的局部正视图,该近侧扩孔钻用于在执行髋关节修正手术期间对患者的股骨的髓内腔进行扩孔;
图54-56为示出试验杆插入工具的正视图,该试验杆插入工具用于在执行髋关节修正手术期间将近侧试验器械联接到远侧杆部件;
图57为示出在执行髋关节修正手术期间被调整的试验颈杆的型式的局部放大透视图;
图58是型式复制器械和近侧主体部件的局部正视图,该型式复制器械和近侧主体部件在执行髋关节修正手术期间联接到所植入的远侧杆部件;
图59为更详细地示出型式复制器械和远侧杆部件的放大正视图,图59是取自图58,如通过圆圈区域所标出的那样,应当注意,为清楚地进行说明,图59已相对于图58旋转90度;
图60是近侧试验器械的局部正视图,该近侧试验器械在执行髋关节修正手术期间联接到型式复制器械;
图61为示出近侧主体部件的型式的局部正视图,该型式在执行髋关节修正手术期间利用型式复制器械被调整成与近侧试验器械的型式相匹配;
图62和63为示出外科手术夯的局部正视图,该外科手术夯用于在执行髋关节修正手术期间接合远侧杆部件和近侧主体部件之间的锥形锁套连接部;
图64为示出锁定螺栓的局部正视图,该锁定螺栓在执行髋关节修正手术期间被插入到近侧主体部件中;
图65和66是锁定螺栓的局部正视图,该锁紧螺栓在执行髋关节修正手术期间通过使用稳杆器和T形扭矩扳手而被拧紧;
图67是模块化股骨假体的锁定螺栓的透视图,该模块化股骨假体在执行髋关节修正手术期间连同近侧主体部件和远侧杆部件使用;
图68是图67所示锁定螺栓的正视图;
图69是沿图68的线69-69截取的沿箭头方向观察的锁定螺栓的剖视图;
图70为更详细地示出锁定螺栓的放大剖视图,其中图70取自图69,如通过圆圈区域所标出的那样;
图71是在执行髋关节修正手术期间使用的试验杆插入工具的另一实施例的正视图;
图72是沿图71的线72-72截取的沿箭头方向观察的试验杆插入工具的剖视图;和
图73是图72的沿线73-73截取沿箭头方向观察的试验杆插入工具的支持承窝的放大剖视图。
具体实施方式
虽然本公开的概念易于具有各种修改形式和替代形式,但本发明的具体示例性实施例已在附图中以举例的方式示出,并且将在本文中详细说明。然而应当理解,本文无意将本发明的概念限制为所公开的具体形式,而是相反,本发明的目的在于涵盖本发明的实质和范围内的所有修改形式、等同形式和替代形式。
在本公开中有关本文所述的整形植入物和患者的自然解剖部分均可以通篇使用表示解剖学参考的术语,例如前侧、后侧、内侧、外侧、上、下等。这些术语在解剖学和整形外科领域均具有公知的含义。除非另外指明,否则说明书和权利要求中使用的此类解剖参考术语旨在符合其公知的含义。
现在参见图1-5,其中示出在执行髋关节修正手术期间使用的模块化股骨假体10。模块化股骨假体10包括近侧主体部件12和远侧杆部件14。如下文中将参照图64-66所述,模块化股骨假体还包括锁定螺栓504,该锁定螺栓用于在近侧主体部件12和远侧杆部件14之间提供副锁(主锁是下文中所述的锥形锁)。假体10配置成在髋关节修正手术期间植入到患者的股骨20(参见图40-57)中。具体地讲,模块化假体10被植入到患者的股骨20的经手术准备(如被扩孔和/或钻孔)的髓内腔22中。
头部部件(未示出)被固定到近侧主体部件12的放大颈杆16的端部,以承靠在患者的天然髋臼或假体承窝上,该假体承窝已被植入到患者的骨盆中以取代其髋臼。通过这种方式,模块化股骨假体10和天然或人工髋臼共同用作取代患者髋关节的系统。
远侧杆部件14可被设置成多个不同的构型,以便满足给定患者的解剖结构的需要。具体地讲,杆部件14可配置成具有多种不同的长度,以适形于患者的解剖结构(如,相对长的杆部件14与长的股骨20一起使用,相对短的杆与短的股骨20一起使用,等等)。此外,如果给定患者的解剖结构需要,远侧杆部件14可被设置成弓形构型。此外,如果给定患者的解剖结构需要,远侧杆部件14也可被设置成具有各种直径。在一个示例性实施例中,杆部件14可被设置成具有四个长度- 140mm、190mm、240mm和290mm。这些杆部件被设置成以1mm的直径增量处于14至31mm的范围内,但在一些实施例中,此范围内的一些尺寸(如,28mm和30mm)可省略。在这样的替代实施例中,可得到具有两个较短长度(即,140mm和190mm长度)的直杆部件,其中可获得角度为3°的三个较长的杆长度(即,190mm、240mm和290mm)来适应股骨前弓的曲率。
同样,近侧主体部件12(和固定到该近侧主体部件的头部部件)也可设置有各种不同的构型,从而得到适形于不同患者的不同解剖结构所需的灵活性。例如,近侧主体部件12可设置有四个不同的长度- 75mm、85mm、95mm和105m。和远侧杆部件14一样,近侧主体部件12也可设置有各种直径。例如,在一个示例性实施例中,近侧主体部件12可设置有三个不同的直径- 20mm、24mm和28mm。近侧主体部件12的偏置可改变,以增大假体10的偏置。头部部件可设置有不同的直径,以满足给定患者的解剖结构的需要。
如图1和图2所示,近侧主体部件12包括主体24,颈杆16从该主体向内侧延伸。头部部件(未示出)渐缩配合或以其他方式固定到伸长颈杆16的端部。主体24中还形成有锥形镗孔28。远侧杆部件14的锥形柱30(参见图3-6)被容纳到近侧主体部件12的锥形镗孔28中。如下文中更详细地讨论,将远侧杆部件14的锥形柱30和限定近侧主体部件12的锥形镗孔28的侧壁朝彼此推动的步骤会将近侧主体部件12锁定到远侧杆部件14。
近侧主体部件12的主体24的上表面具有形成于其中的埋头腔32。埋头腔32的下侧通向锁定沟槽34中。锁定沟槽34的下侧通向连接镗孔36中,该连接镗孔继而通向锥形镗孔28中。如以下所更详细讨论,锁定螺栓504(参见图64)穿过埋头腔32而被插入,并随后延伸穿过连接镗孔36,以接合远侧杆部件14。
如图3-6所示,锥形柱30形成于远侧杆部件14的主体38的上端中。远侧杆部件14的主体38的上表面内形成有一组上部螺纹40。如以下所更详细地讨论,上部螺纹40用于将远侧杆部件14联接到在其使用期间被冲击的外科器械。上部螺纹40的下侧设置有一组下部螺纹42。下部螺纹42用于将远侧杆部件14连同那些在使用中未被冲击的外科器械联接到髋关节假体10的锁定螺栓504(参见图64)。由于在植入股骨假体10期间下部螺纹未受被冲击的外科器械影响,因此最终用于固定假体螺栓的螺纹(即,下部螺纹42)在外科手术期间被保护不受损坏。在本文所述的示例性实施例中,上部螺纹40是M8规格的螺纹,而下部螺纹42是M6规格的螺纹。
在本文所述的示例性实施例中,下部螺纹42体现为专用于释放应力梯级的改进型螺纹。具体地讲,如在图6中最佳示出,下部螺纹42的外边缘54被倒圆。出乎意料的是,测试和建模已经显示,此种倒圆的边缘54能够释放远侧杆部件14中的应力梯级。其中形成有下部螺纹42的盲孔的远端的设计也能另外地释放应力梯级。具体地讲,盲孔的从下部螺纹42向后延伸的远端56是倒圆的,以替代点或其他几何形状。换句话讲,远侧杆部件14的主体38中所形成的从螺纹42向后延伸的盲孔具有倒圆的远端56。和下部螺纹42的圆的外边缘54一样,测试和建模已经出乎意料地显示,此种倒圆的远端56能够释放远侧杆部件14中的应力梯级。
例如呈突出部形式的对齐键44从远侧杆部件14的主体38的上表面向后延伸。对齐键44和远侧杆部件14的顶点一致。换句话讲,弓形杆部件14具有沿其曲率的凸面延伸的顶点(即,脊)。在植入远侧杆部件14期间,该顶点必须与患者的股骨20的具有相似曲率的对应侧适当地对齐。如下文所述,通过甚至在杆部件14位于髓内腔中时允许外科医生看到顶点的位置,对齐键44有利于对远侧杆部件14的顶点进行适当地取向。
如在图4中所示,远侧杆部件14的主体38的上表面内形成有键槽46。键槽46形成于侧壁48中,该侧壁限定上部螺纹40的外部开口50。在本文所述的示例性实施例中,键槽46体现为瓣状槽口,该槽口配置成容纳外科试验器械的瓣状键,但可以使用其他形状的槽口和接片。如下文所述,此种结构允许复制近侧试验主体部件的试验的取向,以用于植入近侧主体部件12。
现在参见图7-43,其中示出用于将股骨假体10植入到患者的股骨20的髓内腔22中的各种器械。在图7中,示出可在患者的股骨20的手术准备的初始步骤中使用的起动器扩孔钻60。起动器扩孔钻60用于扩大患者髓内腔22的其中植入有远侧杆部件14的部分。起动器扩孔钻60包括伸长刀柄62,该刀柄具有用于配合到旋转动力工具86(参见图45)或手动手柄80(参见图8和图44)的卡盘中的近端64。起动器扩孔钻60还包括位于刀柄62的相对的远端处的切割头66。起动器扩孔钻60的切割头66包括锋利的切割末端68,多个螺旋形切割槽70从该切割末端延伸。切割末端68切穿此前移除的股骨假体的任何碎屑或粘固剂残留物。当起动器扩孔钻60位于患者的股骨20的髓内腔22中并旋转时,切割头66对股骨的骨组织进行扩孔或换句话讲进行切割,从而获得通往股骨腔的畅通通道。这种通往股骨腔的通道确保股骨假体10的各部件适当地对齐。
起动器扩孔钻60包括多个着色的深度标记72、74、76和78,这些标记在切割头66的近端上方位置处的其刀柄62上形成。着色的深度标记72、74、76和78中的每一个对应于多个不同近侧主体部件12的标准头部中心。例如,近侧主体部件12可设置有四个不同的长度-75mm、85mm、95mm和105m。在本文所述的示例性实施例中,深度标记72是蓝色的且对应于75mm近侧主体部件12的头部中心的位置,深度标记74是绿色的且对应于85mm近侧主体部件12的头部中心的位置,深度标记76是黄色的且对应于95mm近侧主体部件12的头部中心的位置,且深度标记78是红色的且对应于105mm近侧主体部件12的头部中心的位置。深度标记72、74、76和78可体现为被雕刻在刀柄62中的沟槽,其中每一个填充有对应颜色的环氧树脂油墨。在外科手术期间,起动器扩孔钻60钻到患者的股骨20的髓内腔22中的更深处,直到期望的深度标记与更大的转子84的末端82对齐(参见图44)并且实现通往髓内腔22的畅通通道为止。这样,如果起动器扩孔钻60未被驱动超过适当的着色的深度标记72、74、76和78,则会避免对腔22的远端过度地扩孔。
起动器扩孔钻60的刀柄62的近端64中形成有凸型连接器88。连接器88配合到旋转动力工具86(参见图45)或手动手柄80(参见图8)的卡盘中,以将起动器扩孔钻60联接到旋转驱动源。
起动器扩孔钻60可由医用级金属构造,例如不锈钢、钴铬合金或钛,但可以使用其他金属或合金。此外,在一些实施例中,也可使用诸如聚醚醚酮(PEEK)之类的刚性聚合物。
现在参见图9和图10,其中示出可在对患者的股骨20进行手术准备期间在起动器扩孔钻60之后使用的远侧扩孔钻90。和起动器扩孔钻60一样,远侧扩孔钻90用于对患者髓内腔22的其中植入有远侧杆部件14的部分进行扩孔。使用逐渐增大的远侧扩孔钻90会产生具有容纳股骨假体10的远侧杆部件14所需的最终几何形状(即,形状)的镗孔。远侧扩孔钻90包括伸长刀柄92,该刀柄具有与延伸工具120(参见图11-13)相配合的近端94。如下文中将更详细地描述,延伸工具120又可被固定到旋转动力工具86(参见图45)或手动手柄80(参见图8)的卡盘。
远侧扩孔钻90还包括位于刀柄92的相对的远端98处的切割头96。远侧扩孔钻90的切割头96包括多个螺旋形切割槽100。切割槽100的外部切割表面是渐缩的,以模仿远侧杆部件14的几何形状。当远侧扩孔钻90位于患者的股骨20的髓内腔22中且旋转时,切割槽100对股骨20的骨组织进行扩孔或换句话讲进行切割。
为适应远侧杆部件14的各种不同的构型,远侧扩孔钻90可同样被设置成多种不同的构型。具体地讲,远侧扩孔钻90可配置成具有各种不同的长度,以产生大小足以容纳各种不同长度的远侧杆部件14的扩孔的镗孔(如,相对长的远侧扩孔钻90对股骨20进行准备,以用于植入相对长的杆部件14,相对短的远侧扩孔钻90对股骨20进行准备,以用于植入相对短的杆部件14,等等)。另外,远侧扩孔钻90可被设置成具有各种直径,以产生直径足以容纳具有各种直径的远侧杆部件14的扩孔的镗孔。在一个示例性实施例中,远侧扩孔钻90可被设置成具有四个长度- 140mm、190mm、240mm和290mm。这些扩孔钻90被设置成以1mm的直径增量介于14mm至31mm之间。
远侧扩孔钻90的近端94具有形成于其中的埋头驱动连接器102。驱动连接器102的形状设定成容纳锁定钳口148和延伸工具120的驱动花键126(参见图11-13)。限定驱动连接器102的侧壁104中限定有多个L形锁定槽口106。限定驱动连接器102的侧壁104位于锁定槽口106的后侧,且该侧壁中限定有凹型驱动承窝108。在本文所述的示例性实施例中,凹型驱动承窝108体现为与延伸工具120的驱动花键126的尺寸和形状互补的凹型六角驱动承窝。如以下结合图11-13所述,延伸工具120的锁定钳口148可位于锁定槽口106中并随后与侧壁104接合,以选择性地将延伸工具120锁定到远侧扩孔钻90的近端94。这样做时,延伸工具的驱动花键126便被容纳到远侧扩孔钻90的凹型驱动承窝108中。当延伸工具120以此种方式被锁定到远侧扩孔钻90时,延伸工具的驱动花键126的旋转会使远侧扩孔钻90旋转。
如在图10的横截面中所示,盲孔110的近端通向连接器102中。盲孔110远离凹型驱动承窝108朝远侧延伸。盲孔110的上端具有螺纹。即,限定盲孔110近端的侧壁中形成有多个螺纹112。在本文所述的示例性实施例中,螺纹112不贯穿盲孔110的整个长度延伸。因此,镗孔的远端是光滑的(即,不具有螺纹)。螺纹112的尺寸设定成与远侧杆部件14的下部螺纹42相匹配。这样,在本文所述的示例性实施例中,螺纹112是M6规格的螺纹。
和起动器扩孔钻60一样,远侧扩孔钻90可由医用级金属构造,例如不锈钢、钴铬合金或钛,但可以使用其他金属或合金。此外,在一些实施例中,也可使用诸如聚醚醚酮(PEEK)之类的刚性聚合物。
现在参见图11-13,其中示出可在对患者的股骨20进行手术准备期间与远侧扩孔钻90结合使用的延伸工具120。延伸工具120可用于驱动远侧扩孔钻90对患者髓内腔22的其中植入有远侧杆部件14的部分进行扩孔。延伸工具120包括伸长的驱动轴122,该驱动轴具有用于配合到旋转动力工具86(参见图45)或手动手柄80(参见图8)的卡盘中的近端124。延伸工具120还包括位于驱动轴122的相对的远端128处的驱动花键126。延伸工具120的驱动花键126包括多个驱动齿130。当驱动花键126的驱动齿130位于远侧扩孔钻90的凹型驱动承窝108中时,驱动轴122联接到远侧扩孔钻90。因此,驱动轴122的旋转会导致远侧扩孔钻90的旋转。
延伸工具120的驱动轴122包括伸长的轴主体132。凸型连接器134形成于轴主体132的近端136中。连接器134配合到旋转动力工具86(参见图45)或手动手柄80(参见图8)的卡盘中,以将驱动轴122联接到旋转驱动源。套筒138围绕轴主体132而定位。套筒138通过轴承140而联接到轴主体132的外表面。因此,轴主体132(以及因此驱动轴122)独立于套筒138而旋转。套筒138用作夹持件,以用于允许外科医生在驱动轴122旋转期间握住延伸工具120。
伸长末端142远离轴主体132的远端朝远侧延伸。具体地讲,伸长末端142的近端144被固定到轴主体132的远端146。伸长末端142具有形成于其远端中的一对锁定凸缘148。锁定钳口148相对地面向彼此。末端142具有延伸穿过其中的伸长镗孔150。伸长镗孔150的远端(即,孔150的接近锁定钳口148的部分)限定远侧镗孔152,该远侧镗孔的直径小于孔150的其余部分所限定的近侧孔154。限定远侧镗孔152的侧壁具有内部几何形状,该内部几何形状与驱动花键126的外部几何形状相匹配。此种互补特征增强了延伸工具120在驱动远侧扩孔钻90时的旋转稳定性。
驱动轴122还包括锁定组件156。锁定组件156包括锁定杠杆158,该锁定杠杆经由枢轴销160可枢转地联接到轴主体132。弹簧连杆162的一端联接到锁定杠杆158,其另一端联接到花键轴166的近端164。驱动花键126形成于花键轴166的远端168中。驱动花键126可定位在延伸或锁定位置(如图13所示)和回缩或解锁位置之间,在延伸或锁定位置中,驱动花键126伸出伸长末端142的远端,在回缩或解锁位置中,驱动花键162回缩到伸长末端142的远侧镗孔152中位于锁定钳口148近侧的位置处。
为将延伸工具120固定到远侧扩孔钻90,穿过远侧扩孔钻的驱动连接器102的锁定槽口106的开口端插入锁定钳口148并随后使其旋转。接着,将驱动花键126定位在其延伸(即,锁定)位置,以将延伸工具120固定到远侧扩孔钻90,在所述延伸位置中,所述驱动花键被容纳到远侧扩孔钻的凹型驱动承窝108中。
由于经由弹簧连杆162联接到花键轴166,锁定杠杆158为可操作的,以使驱动花键126在其延伸(即,锁定)位置和其回缩(即,解锁)位置之间移动。也就是说,当锁定杠杆158位于其锁定位置(如图13所示)时,驱动花键位于其延伸(即锁定)位置。然而,当向下(沿图13所示的取向)拉动锁定杠杆158以便围绕枢轴销160枢转时,弹簧连杆162和花键轴166被推向右侧(沿图13所示的取向),以便释放弹簧连杆162的张力并将驱动花键126定位在其回缩(即,解锁)位置。
延伸工具120包括形成于其伸长末端142上的多个着色的深度标记172、174、176和178。和起动器扩孔钻60的深度标记72、74、76和78一样,着色的深度标记172、174、176和178中的每一个对应于各种近侧主体部件12中的一者的标准头部中心。例如,近侧主体部件12可设置有四个不同的上部/下部长度- 75mm、85mm、95mm和105m。在本文所述的示例性实施例中,深度标记172是蓝色的且对应于75mm近侧主体部件12的头部中心的位置,深度标记174是绿色的且对应于85mm近侧主体部件12的头部中心的位置,深度标记176是黄色的且对应于95mm近侧主体部件12的头部中心的位置,且深度标记178是红色的且对应于105mm近侧主体部件12的头部中心的位置。深度标记172、174、176和178可体现为被雕刻在伸长末端142中的沟槽,其中每一个填充有对应颜色的环氧树脂油墨。在外科手术期间,延伸工具120钻进患者的股骨20的髓内腔22中的更深处,直到期望的深度标记与更大的转子84的末端82对齐(参见图45)为止。这样,如果延伸工具120未被驱动超过适当的着色的深度标记172、174、176和178,则会避免对腔22的远端过度地扩孔。
延伸工具120配置成与各种构型的远侧扩孔钻90中的任一者相配合。换句话讲,各种构型的远侧扩孔钻90中的每一个与延伸工具120相容。
延伸工具120的金属部件(如,驱动轴126、远侧末端142等的各种部件)可由医用级金属构造,例如不锈钢、钴铬合金或钛,但可以使用其他金属或合金。此外,在一些实施例中,也可使用诸如聚醚醚酮(PEEK)之类的刚性聚合物。套筒138可由相似的金属或由诸如迭尔林之类的聚合物构造。
现在参见图14-20,其中示出近侧试验器械180。近侧试验器械180是模块化的,因此体现为两个分开的部件-试验轴182和试验颈杆184。和本文所述的其他器械和植入物一样,近侧试验器械180的部件(即,试验轴182和试验颈杆184)可被设置成具有多个不同的尺寸。例如,在本文所述的示例性实施例中,试验轴182可体现为具有四个不同的长度(如,75mm、85mm、95mm、或105mm),以便在组装到远侧扩孔钻90或远侧杆部件14时模仿75mm、85mm、95mm或105mm的近侧主体部件12。在本文所述的示例性实施例中,试验颈杆184可被设置成具有两个不同的偏置尺寸- 45mm和40mm。试验轴182和试验颈杆184的各种构型可混合并相互配合,以产生不同尺寸的试验品。此种模块化器械显著减小了执行相关外科手术所需的器械数目。例如,一些现有技术的试验器械套件包括12个不同的近侧试验器械,而本文所述的示例性系统具有六个器械(四个试验轴和两个试验颈杆)。
如在图14-17中所示,试验轴182包括主体186,该主体具有延伸穿过其中的伸长镗孔188。锁紧螺钉190被捕集在镗孔188中。锁紧螺钉190的近端中形成有六角驱动头部192,其相对的远端中形成有多个锁定螺纹194。螺纹194的尺寸设定成容纳到远侧杆部件14的下部螺纹42和远侧扩孔钻90的螺纹112中。因此,在本文所述的示例性实施例中,锁紧螺钉190的螺纹194是M6规格的螺纹。如在图14的透视图和图17的剖视图中所示,锁紧螺钉190的驱动头部192被捕集在轴承196中且位于试验轴主体186的近端中所形成的沟槽198中。
试验轴182的主体186的形状一般是圆柱体的。主体186的近端202限定了杆204,以容纳试验颈杆184。主体186中形成有肩部206。试验颈杆184在杆204上向下滑动并由肩部206支撑。如在图14-16中所示,杆204具有形成于其中的花键表面208。如下文中更详细地描述,花键表面208被试验颈杆184的锁定棘爪244接合(参见图18),以将试验颈杆184相对于试验轴182锁定在期望取向或“型式”(即,转动角)中。
如在图14-16中所示,试验轴的主体186中形成有对齐平面210。平面210靠近主体远端212形成。对齐平面210体现为平浅的槽口。平面210有利于在外科手术期间插入近侧试验器械180。
试验轴182还包括对齐键214,该对齐键呈例如肋的形式,该肋从主体186的远端212向外延伸。对齐键214的长轴在向上/向下方向上延伸。对齐键214配置成与形成于远侧杆部件14的主体38上表面中的键槽46(参见图4)相配合。在本文所述的示例性实施例中,对齐键214的横截面形状是瓣状的,以与杆部件的键槽46的形状互补。
如图18-20所示,试验颈杆184包括主体224,该主体具有自其向内侧延伸的颈杆226。试验头部(未示出)以渐缩配合或其他方式固定到颈杆226。主体224中还形成有镗孔228。镗孔228贯穿主体224的侧部在向上/向下方向上延伸。试验轴182的近侧杆204被容纳到试验颈杆184的镗孔228中。试验颈杆184在试验轴182的杆204上向下滑动,直到试验颈杆的主体224的下表面230接触形成于试验轴的主体186中的肩部206(参见图14-17)为止。
试验颈杆184的主体224的上表面内形成有埋头腔232。埋头腔232的下侧通向锁定沟槽234中。腔232和沟槽234容纳锁定机构236。锁定机构236包括摩擦夹钳238和锁紧螺钉240。锁紧螺钉240的近端中形成有六角驱动头部242。当试验颈杆184位于试验轴182上时,锁定机构236可用于将试验颈杆184相对于试验轴182锁定到期望取向或“型式”(即,转动角)中。具体地讲,当用六角驱动器(例如图56中所示的驱动器)拧紧锁紧螺钉240时,摩擦夹钳238夹持或以其他方式接合试验轴182的杆204的外表面,从而防止试验颈杆184相对于试验轴182旋转。如在图18中所示,摩擦夹钳238具有形成于其中的锁定棘爪244。当使用六角驱动器512(例如图56中所示的驱动器)拧紧锁紧螺钉240时,锁定棘爪244被推动到位于试验轴182的花键表面208的沟槽中的一者的位置中。锁定棘爪244接触形成花键表面208的沟槽的侧壁,从而防止试验颈杆184相对于试验轴182旋转。当用六角驱动器放松锁紧螺钉240时,摩擦夹钳238脱离试验轴182的杆204,从而使试验颈杆184能够围绕试验轴182自由地旋转。
近侧试验器械180的试验轴182和试验颈杆184可由医用级金属构造,例如不锈钢,钴铬合金或钛,但可以使用其他金属或合金。此外,在一些实施例中,也可使用诸如聚醚醚酮(PEEK)之类的刚性聚合物。
现在参见图21-23,其中示出扩孔钻导引器轴250。扩孔钻导引器轴250可固定到位于患者的股骨20的髓内腔22中的远侧杆部件14或远侧扩孔钻90,以引导外科医生推进修整锉刀290(参见图24和图25)或近侧扩孔钻390(参见图30-32)。扩孔钻导引器轴250包括主体252,该主体具有延伸穿过其中的伸长镗孔254。锁紧螺钉256被捕集在镗孔254中。锁紧螺钉256的近端中形成有六角驱动承窝258,其相对的远端中形成有多个锁定螺纹260。如下文中所更详细地描述,可将六角驱动器插入到六角驱动承窝258中并进行旋转,以将扩孔钻导引器轴250拧紧到远侧杆部件14或远侧扩孔钻90。锁紧螺钉的螺纹260的尺寸设定成容纳到远侧杆部件14的下部螺纹42和远侧扩孔钻90的螺纹112中。因此,在本文所述的示例性实施例中,锁紧螺钉256的螺纹260是M6规格的螺纹。
扩孔钻导引器轴250的主体252的远端262具有形成于其中的对齐平面264。对齐平面264体现为平浅的槽口。对齐平面264的尺寸和形状设定成与对齐键44的尺寸和形状紧密互补,该对齐键从远侧杆部件14的主体38的上表面向上延伸。如上所述,对齐键44与远侧杆部件14的顶点对齐。在将扩孔钻导引器轴250附接到远侧杆部件14期间,对齐键44邻接并接触形成于扩孔钻导引器轴的主体252中的对齐平面264。
和近侧试验器械180的试验轴182一样,扩孔钻导引器轴250还包括对齐键284,该对齐键呈例如肋的形式,该肋从主体252的远端262向外延伸。对齐键284的长轴在向上/向下方向上延伸。对齐键284配置成与形成于远侧杆部件14的主体38上表面中的键槽46(参见图4)相配合。在本文所述的示例性实施例中,对齐键284的横截面形状是瓣状的,以与杆部件的键槽46的形状互补。
扩孔钻导引器轴250包括形成于其主体252上的多个着色的深度标记272、274、276和278。和起动器扩孔钻60的深度标记72、74、76和78以及延伸工具120的深度标记172、174、176和178一样,着色的深度标记272、274、276和278中的每一个对应于各种近侧主体部件12中的一者的标准头部中心。例如,如上所述,近侧主体部件12可设置有四个不同的上部/下部长度- 75mm、85mm、95mm和105m。在本文所述的示例性实施例中,深度标记272是蓝色的且对应于75mm近侧主体部件12的头部中心的位置,深度标记274是绿色的且对应于85mm近侧主体部件12的头部中心的位置,深度标记276是黄色的且对应于95mm近侧主体部件12的头部中心的位置,且深度标记278是红色的且对应于105mm近侧主体部件12的头部中心的位置。深度标记272、274、276和278可体现为在扩孔钻导引器轴250的主体252中雕刻出的沟槽,其中每一个填充有对应颜色的环氧树脂油墨。
扩孔钻导引器轴250还包括形成于其近端附近的另一着色标记280。如在图21和图22中所示,扩孔钻导引器轴的主体252的外表面内形成有着色标记280。和着色的深度标记272、274、276和278一样,着色标记280可体现为在扩孔钻导引器轴的主体252中所雕刻出的沟槽,且填充有预定颜色的环氧树脂油墨,或者作为另外一种选择,可体现为激光标记。在本文所述的示例性实施例中,着色标记280是黑色的。如下文中将更详细地描述,着色标记280允许外科医生通过透过形成于修整锉刀290中的窗口314(参见图24和图25)或形成于近侧扩孔钻390中的窗口414(参将图30-32)观察着色标记280而在视觉上确认已达到适当座置高度。具体地讲,在外科手术期间,将修整锉刀290(参见图24和图25)或近侧扩孔钻390(参见图30-32)推进到患者的股骨20的髓内腔22中的更深处,直到可透过形成于修整锉刀290中的窗口314(参见图24和图25)或形成于近侧扩孔钻390中的窗口414(参将图30-32)观察到着色标记280为止。这样,可避免对髓内腔22的过度锉整或过度扩孔。
扩孔钻导引器轴250可由医用级金属构造,例如不锈钢、钴铬合金或钛,但可以使用其他金属或合金。此外,在一些实施例中,也可使用诸如聚醚醚酮(PEEK)之类的刚性聚合物。
现在参见图24和图25,其中更详细地示出了修整锉刀290。修整锉刀290用于对某些患者的股骨20进行手术准备。例如,当在未呈现大的近侧畸形的患者体内植入具有相对小的直径(如,14-20mm)的弓形远侧杆部件14时,可能需要使用修整锉刀290。修整锉刀290移除额外的骨,以便于适当地座置弓形的远侧杆部件14。
和本文所述的其他器械和植入物一样,修整锉刀290可被设置成具有多种不同的尺寸。例如,修整锉刀290可被设置成具有各种直径,以适应各种不同远侧杆部件14的不同直径。在一个示例性实施例中,杆部件14可被设置成以1mm的增量介于14mm到31mm之间。在这种情况下,修整锉刀290可被设置成具有相似的尺寸。
修整锉刀290包括伸长轴292,该伸长轴具有固定到其近端296的手柄294。修整锉刀290也包括固定到轴292的相对的远端302的切割头298。修整锉刀290的切割头298是弓形的,并在其两个外侧上包括多个切割齿304。切割齿304沿切割头298的长度纵向地延伸。当修整锉刀290以摆动运动推进时,修整锉刀290的切割齿304沿两个方向研磨或换句话讲切割股骨20的骨组织,从而逐渐形成凹口,该凹口具有容纳弓形远侧杆部件14所需的几何形状(即,形状)。
如在图25中所示,手柄294位于修整锉刀290的轴292上,使得手柄294的一端长于另一端。此能为外科医生提供对切割头298位置的视觉参考。也就是说,切割头298与手柄294的较短侧位于轴292的同一侧上。这样做时,手柄294的较短侧使外科医生能够在使用修整锉刀290期间在视觉上参照切割头298的位置。这允许切割头298相对于远侧杆部件的顶点的期望位置以180°对齐。
修整锉刀290的轴292具有形成于其中的导向盲孔306。如在图25的剖视图中所示,导孔306的远端308在邻近切割头298的位置处限定在修整锉刀290的轴292的远端302中(即,贯穿该远端开口)。如上所述,切割头298的形状一般是弓形的,其凹面面向轴292的中心轴线。这种形状为扩孔钻导引器轴250提供进入导孔306的间隙。
导孔306的相对的近端310位于锉刀的伸长轴292中的其近端296和其远端302之间的位置处。导孔306的近端310位于轴292的中间的近侧上,靠近轴292向下渐缩至其固定到手柄294的较小直径的位置。导孔306的中心线和修整锉刀290的纵向轴线位于同一条线上。
限深器312位于导孔306的近端310中。当修整锉刀290完全就位时,限深器312在扩孔钻导引器轴的锁紧螺钉256的驱动承窝258的上表面282上落到最低处(参见图21- 23)。在本文所述的示例性实施例中,限深器312体现为榫钉销,该榫钉销以一横切锉刀轴292的纵向轴线的角度被焊接到形成于该轴中的镗孔中。应当理解,也可使用限深器的其他构型,包括与锉刀轴292成一体的构型。
如在图24和图25中所示,锉刀轴292的用于限定导孔306的侧壁316中限定有多个开槽的开口或“观察窗”314。观察窗314允许外科医生在扩孔钻导引器轴250被容纳到导孔306内时观察扩孔钻导引器轴。这样做时,外科医生能通过透过形成于修整锉刀290中的观察窗314观察扩孔钻导引器轴250的着色标记280而在视觉上确认已实现对修整锉刀290的适当座置。具体地讲,如在图24的正视图中所示,锉刀轴292的外表面内形成有着色标记318。着色标记318围绕轴292的外周边延伸,并与观察窗314相交。和着色深度扩孔钻导引器轴250的着色标记280一样,着色标记318可体现为在锉刀轴292的外表面内所雕刻出的沟槽,且填充有预定颜色的环氧树脂油墨,或者作为另外一种选择,可体现为激光标记。在本文所述的示例性实施例中,着色标记318是黑色的。当扩孔钻导引器轴250的着色标记280(其可透过观察窗314看见)与修整锉刀290的着色标记318对齐时,外科医生可在视觉上确认已实现对修整锉刀290的适当座置。
在本文所述的示例性实施例中,修整锉刀290被设计成用于移除适量骨组织的修整工具。因此,与本文所述的其他实施例不同,手柄294不可移除地(例如通过焊接)固定到锉刀轴292的近端296。此种设置防止修整锉刀290联接到动力工具。在其他设置中,可能期望实现电动型锉刀。在这种情况下,可采用可移除手柄,例如图8的手动手柄80。
修整锉刀290可由医用级金属构造,例如不锈钢、钴铬合金或钛,但可以使用其他金属或合金。此外,在一些实施例中,也可使用诸如聚醚醚酮(PEEK)之类的刚性聚合物。
现在参见图26和图27,其中示出杆插入工具330。可将杆插入工具330固定到远侧杆部件14,以便于将远侧杆部件14植入到患者的股骨20的髓内腔22中。杆插入工具330包括主体332,该主体具有延伸穿过其中的伸长镗孔334。套筒336定位在杆插入工具的主体332周围。套筒336例如通过重叠注塑而不可移动地联接到杆插入工具主体332的外表面。套筒336用作夹持件,以允许外科医生在植入远侧杆部件14时握住杆插入工具。
锁定杆338被捕集在镗孔334中。旋钮340被固定在锁定杆338的近端。除用于将杆插入工具330固定到远侧杆部件14之外,旋钮340还用作冲击表面。也就是说,外科医生击打旋钮340的上表面342,以将远侧杆部件14驱动到患者的股骨20的髓内腔22内的骨组织中。如在图26和图27中所示,旋钮340具有形成于其中的多个孔362。可将杆或其他类型的手柄(未示出)插入到孔362中,以在旋钮340旋转期间增大外科医生的杠杆效率。
如在图27的横截面中所示,形成于镗孔334内的主体332中的一组内部螺纹344和锁定杆338上的一组外部螺纹358容许锁定杆338与镗孔334保持在一起,同时还允许在两次使用之间拆卸杆插入工具330以进行清洗。
锁定杆338的远端中形成有一组锁定螺纹346。螺纹346的尺寸设定成容纳到远侧杆部件14的上部螺纹40(参见图6)中。如上所述,上部螺纹40用于将远侧杆部件14联接到杆插入工具330以及在其使用期间受到冲击的任何其他外科器械。因此,未用于将锁定螺栓504组装到股骨假体10的一组螺纹(即,上部螺纹40)会受到与外科医生对杆插入工具330施加的冲击相关联的负荷。这样做时,将锁定螺栓504组装到股骨假体10时所使用的一组螺纹(即,下部螺纹42)不会受到与外科医生对杆插入工具330施加的冲击相关联的负荷。此种“螺纹保护”确保了用于容纳锁定螺栓504的杆部件螺纹(即,下部螺纹42)不会因柄插入过程而受损。换句话讲,由于在植入股骨假体10期间下部螺纹42未受被冲击的外科器械影响,因此最终用于固定假体的锁定螺栓504的螺纹(即,下部螺纹42)在外科手术期间被保护不受损坏。如上所述,远侧杆部件14的上部螺纹40是M8规格的螺纹,而下部螺纹42是M6规格的螺纹。因此,杆插入工具330的锁定螺纹346是M8规格的螺纹。由于螺纹规格较大(如,M8对M6),杆插入工具330的锁定螺纹346无法被无意地驱动到远侧杆部件14的下部螺纹42中。
杆插入工具330的主体332的远端348具有形成于其中的对齐凹口350。对齐凹口350的尺寸和形状设定成与对齐键44的尺寸和形状紧密互补,该对齐键从远侧杆部件14的主体38的上表面向上延伸(参见图4)。如上所述,对齐键44与远侧杆部件14的顶点对齐。在将杆插入工具330附接到远侧杆部件14期间,对齐键44被容纳到形成于杆插入工具的主体332中的对齐凹口350中。
杆插入工具330的主体332的远端348固定有保持凸缘360。保持凸缘360围绕主体332的外周边的一部分延伸。如下文中更详细地讨论,保持凸缘360防止锥形件保护套筒380在杆插入工具330的使用期间无意地从远侧杆部件14脱离。
一对冲击翼352从杆插入工具330的主体332的近端354向外延伸。在本文所述的示例性实施例中,冲击翼352与杆插入工具330的主体332形成为一体。如上所述,在植入远侧杆部件14期间,外科医生击打旋钮340的上表面342,以将远侧杆部件14驱动到患者的股骨20的髓内腔22内的骨组织中(即,沿向下的方向驱动远侧杆部件14)。如果外科医生需要从患者的股骨20的髓内腔22重新定位或移除远侧杆部件14(其中远侧杆部件14仍固定到该髓内腔),则外科医生击打冲击翼352的底侧356(即,冲击翼352的下侧)。此种冲击会沿向上的方向驱动杆插入工具330(以及因此附接到杆插入工具的远侧杆部件14),从而允许将杆插入工具从患者的股骨20的髓内腔22移除,或在该髓内腔内对其进行重新定位。
一旦外科医生已将远侧杆部件14定位在患者的股骨20的髓内腔22中,就可以通过旋转旋钮340以将锁定螺纹346从远侧杆部件14的上部螺纹40释放而使杆插入工具330从远侧杆部件14脱离。
杆插入工具330包括形成于其主体332上的多个着色的深度标记372、374、376和378。和起动器扩孔钻60的深度标记72、74、76和78、延伸工具120的深度标记172、174、176和178、以及扩孔钻导引器轴250的深度标记272、274、276和278一样,着色的深度标记372、374、376和378中的每一个对应于各种近侧主体部件12中的一者的标准头部中心。例如,如上所述,近侧主体部件12可设置有四个不同的上部/下部长度- 75mm、85mm、95mm和105m。在本文所述的示例性实施例中,深度标记372是蓝色的且对应于75mm近侧主体部件12的头部中心的位置,深度标记374是绿色的且对应于85mm近侧主体部件12的头部中心的位置,深度标记376是黄色的且对应于95mm近侧主体部件12的头部中心的位置,且深度标记378是红色的且对应于105mm近侧主体部件12的头部中心的位置。深度标记372、374、376和378可体现为在杆插入工具330的主体332中雕刻出的沟槽,其中每一个填充有对应颜色的环氧树脂油墨。在外科手术期间,杆插入工具330(其中远侧杆部件14固定到该杆插入工具)钻进患者的股骨20的髓内腔22中的更深处,直到期望的深度标记与更大的转子84的末端82对齐(参见图51)为止。这样,可将远侧杆部件14植入到期望的植入深度。
杆插入工具330的金属部件(例如,杆插入工具的主体332、锁定杆338等等)可由医用级金属构造,例如不锈钢、钴铬合金或钛,但可以使用其他金属或合金。此外,在一些实施例中,也可使用诸如聚醚醚酮(PEEK)之类的刚性聚合物。夹持件336可由例如硅树脂等聚合物构造。
现在参见图28和图29,其中示出锥形件保护套筒380。在本文所述的示例性实施例中,锥形件保护套筒380与远侧杆部件14包装在一起。锥形件保护套筒380被安装在形成于远侧杆部件14的上端中的锥形柱30上(参见图50-52)。如上所述,远侧杆部件14的锥形柱30被容纳到近侧主体部件12的锥形镗孔28中,其中所施加的压缩力将两个部件以锥形锁套的方式锁定在一起。锥形件保护套筒380减少或甚至消除外科手术过程中对远侧杆部件14的锥形柱30的外表面的潜在损坏,从而提高远侧杆部件14和近侧主体部件12之间的锥形锁套的完整性。锥形件保护套筒380包括空心主体382,该主体具有延伸穿过其中的伸长镗孔384。
位于伸长镗孔384中的斜面边缘386将锥形件保护套筒380分成上部和下部。当锥形件保护套筒380组装到远侧杆部件14的主体38时,锥形件保护套筒380的斜面边缘386的近侧起点接合远侧杆部件14的锥形柱30的近侧表面。在这种组装过程中,锥形件保护套筒380的主体382接合伸长镗孔384远端的部分也接合远侧杆部件14的锥形柱30的远侧表面。因此,锥形件保护套筒380的上部坐于远侧杆部件14的主体38的上表面的上方。这样,锥形件保护套筒380的上部用作夹持件,该夹持件被力或其他器械夹持或以其他方式接合,以有利于锥形件保护套筒380在其使用后被移除。锥形件保护套筒380的上部的外表面包括多个肋388。肋388在锥形件保护套筒380的移除期间提供外科钳的接合表面。
如上所述,锥形件保护套筒380与远侧杆部件14包装在一起。因此,它连同远侧杆部件14在无菌包装件中被提供给外科医生。锥形件保护套筒380可预装在远侧杆部件14上,因此与远侧杆部件14在同一无菌包装件中被提供给外科医生。作为另外一种选择,锥形件保护套筒380可在与包括远侧杆部件14的无菌包装件分开的无菌包装件中被提供给外科医生。在这种情况下,外科医生从单独的包装件中移除锥形件保护套筒380并将其在植入前安装到远侧杆部件14上。
锥形件保护套筒380可由任何适宜的材料制成,包括医用级聚合物材料。此种聚合物材料的例子包括聚乙烯,例如超高分子量聚乙烯(UHMWPE)或聚醚醚酮(PEEK)。在这种构型中,锥形件保护套筒380可用作一次性器械。
现在参见图30-32,其中为更详细地示出近侧扩孔钻390。近侧扩孔钻390用于对患者的股骨20进行手术准备,用于植入近侧主体部件12。如下文中结合图48所述,在远侧杆部件14上方进行近侧扩孔钻390的操作,以确保最终的座置高度和杆的生物力学。在一些实施例中,当远侧扩孔钻90位于患者的股骨20中时,也可在远侧扩孔钻90上方进行近侧扩孔钻390的操作。
和本文所述的其他器械和植入物一样,近侧扩孔钻390可被设置成具有多种不同的尺寸。例如,近侧扩孔钻390可被设置成具有各种直径,以适应近侧主体部件12的各种不同的构型。在一个示例性实施例中,近侧扩孔钻390可设置有20mm、24mm和28mm的切割头直径。
近侧扩孔钻390包括伸长轴392,该伸长轴具有用于配合到旋转动力工具86(参见图53)或手动手柄80(参见图8)的卡盘中的近端394。近侧扩孔钻390还包括位于轴392的相对的远端398处的切割头396。近侧扩孔钻390的切割头396包括多个螺旋形切割槽402。当近侧扩孔钻390位于患者的股骨20中并进行旋转时,切割槽402对股骨20的骨组织进行扩孔或换句话讲进行切割,以形成用于容纳近侧主体部件12的几何形状的手术形成的腔。切割头396的形状一般是圆柱体的或锥形的。切割头396的中心线和近侧扩孔钻390的纵向轴线位于同一条线上。如在图30和图31中所示,切割槽402的切割前缘404延伸超出轴392的远端398。
近侧扩孔钻390的轴392具有形成于其中的导向盲孔406。如在图32的剖视图中所示,导孔406的远端408在邻近切割头396的位置处限定在近侧扩孔钻390的轴392的远端398中(即,贯穿该远端而开口)。导孔406的相对的近端410位于扩孔钻伸长轴392的近端394附近。导孔406的中心线和近侧扩孔钻390的纵向轴线位于同一条线上。
限深器412位于导孔406的近端410中。当近侧扩孔钻390完全就位时,限深器412在扩孔钻导引器轴250的锁紧螺钉256的驱动承窝258的上表面282上落到最低处(参见图22和23)。在本文所述的示例性实施例中,限深器412体现为榫钉销,该榫钉销以一横切扩孔钻轴392的纵向轴线的角度被焊接到形成于该轴中的镗孔中。应当理解,也可使用限深器的其他构型,包括与扩孔钻轴392成一体的构型。
如在图30-32中所示,扩孔钻轴392的用于限定导孔406的侧壁416中限定有多个开槽的开口或“观察窗”414。观察窗414允许外科医生在扩孔钻导引器轴250被容纳到导孔406内时观察扩孔钻导引器轴。这样做时,外科医生能通过透过形成于近侧扩孔钻390中的观察窗414观察扩孔钻导引器轴250的着色标记280而在视觉上确认已实现对近侧扩孔钻390的适当座置。具体地讲,如在图30的正视图中所示,扩孔钻轴392的外表面内形成有着色标记418。着色标记418围绕轴392的外周边延伸,并与观察窗414相交。和着色深度扩孔钻导引器轴250的着色标记280一样,着色标记418可体现为在扩孔钻轴392的外表面内所雕刻出的沟槽,且填充有预定颜色的环氧树脂油墨,或者作为另外一种选择,可体现为激光标记。在本文所述的示例性实施例中,着色标记418是黑色的。当扩孔钻导引器轴250的着色标记280(其可透过观察窗414看见)与近侧扩孔钻390的着色标记418对齐时,外科医生可在视觉上确认已实现对近侧扩孔钻390的适当座置。
凸型连接器420形成于扩孔钻轴392的近端394中。连接器420配合到旋转动力工具86(参见图53)或手动手柄80(参见图8)的卡盘中,以将近侧扩孔钻390联接到旋转驱动源。
近侧扩孔钻390包括形成于其主体392上的多个着色的深度标记422、424、426和428。和起动器扩孔钻60的深度标记72、74、76和78、延伸工具120的深度标记172、174、176和178、扩孔钻导引器轴250的深度标记272、274、276和278、以及杆插入工具330的深度标记372、374、376和378一样,着色的深度标记422、424、426和428中的每一个对应于各种近侧主体部件12中的一者的标准头部中心。例如,如上所述,近侧主体部件12可设置有四个不同的上部/下部长度- 75mm、85mm、95mm和105m。在本文所述的示例性实施例中,深度标记422是蓝色的且对应于75mm近侧主体部件12的头部中心的位置,深度标记424是绿色的且对应于85mm近侧主体部件12的头部中心的位置,深度标记426是黄色的且对应于95mm近侧主体部件12的头部中心的位置,且深度标记428是红色的且对应于105mm近侧主体部件12的头部中心的位置。深度标记422、424、426和428可体现为在近侧扩孔钻390的主体392中雕刻出的沟槽,其中每一个填充有对应颜色的环氧树脂油墨。
近侧扩孔钻390可由医用级金属构造,例如不锈钢、钴铬合金或钛,但可以使用其他金属或合金。
现在参见图33和图34,其中示出试验杆插入工具430。试验杆插入工具430可用于夹紧近侧试验器械180以便于将其附接到植入于患者的股骨20的髓内腔22中的远侧扩孔钻90或远侧杆部件14。试验杆插入工具430与一把手术剪或手术钳的类似之处在于,它包括相对于枢轴销434一起枢转的一对杠杆432。杠杆432中的每一个的近端固定有手柄或环436。杠杆432的远端配合形成圆柱体的保持承窝442。保持承窝442的尺寸和形状设定成容纳形成于试验轴182的近端202中的杆204。具体地讲,如图35的正视图所示,保持承窝442具有形成于其中的沟槽444。沟槽444的尺寸设定成紧密地模仿试验轴182的杆204的外表面的尺寸,以便将该外表面容纳到沟槽中。如在图35的正视图中同样所示,沟槽444配置有“三瓣”几何形状,以确保保持承窝442牢固地接合试验轴182。
当外科医生将两个环436彼此远离地推动时,杠杆432围绕销434枢转,且保持承窝442的两半略微地远离彼此伸展。试验轴182的杆204可随后被推进到保持承窝442的沟槽444中。然后,外科医生可挤压或换句话讲将两个环436朝彼此推动,从而使杠杆432围绕销434朝彼此枢转。这样做能将保持承窝442的两半朝彼此推动,从而挤压试验轴182的杆204,以便将试验轴182保持在保持沟槽442中。如在图33中所示,试验杆插入工具430的杠杆432中的每一个中在环436之间的位置处形成有多个棘齿446。棘齿446允许外科医生将杠杆432锁定在一位置处,在该位置中,试验轴182被锁定在保持承窝442中。
试验杆插入工具430可由医用级金属构造,例如不锈钢、钴铬合金或钛,但可以使用其他金属或合金。
现在参见图36-39,其中示出型式复制器械460。如下文中将结合图58-61更详细地描述,可使用型式复制器械460来确保被植入的近侧主体部件12的型式复制在试验期间利用近侧试验器械180所确定的型式。
型式复制器械460包括伸长轴462,该伸长轴具有从其远端466延伸的对齐柄464。在本文所述的示例性实施例中,形式复制器械460体现为单一部件。因此,对齐柄464与伸长轴462形成为一体。呈例如肋形式的对齐键468从对齐柄464向外延伸。对齐键468的纵向轴线在向上/向下方向上延伸。对齐键468配置成与形成于远侧杆部件14的主体38上表面中的键槽46(参见图4)相配合。在本文所述的示例性实施例中,对齐键468的横截面形状是瓣状的,以与杆部件的键槽46的形状互补。这样,对齐键468与对齐键214相同,所述对齐键形成于近侧试验器械180的试验轴182的远端212上(参见图14-16)。
如图39的横截面所示,型式复制器械的轴462具有形成于其近端472中的埋头盲孔470。轴的近端472中还形成有对齐槽口474。和对齐键468一样,对齐槽口474的纵向轴线在向上/向下方向上延伸。对齐槽口474的近端476是开口的,其远端478被封闭在轴462中。如在图39的剖视图中所示,对齐槽口474通向形成于轴462中的孔470中。
如在图36中所示,型式复制器械的对齐槽口474与其对齐键468对齐。具体地讲,对齐槽口474的纵向轴线和对齐键的纵向轴线位于相同假想线480上。
如下文中参照图58-61更详细地讨论,在将近侧主体部件12以锥形锁套锁定到所植入的远侧杆部件14的外科手术期间,近侧试验器械180的试验轴182的远端212(参见图14-16)被插入到形成于型式复制器械轴462的近端中的盲孔470中。这样做时,形成于近侧试验器械180的试验轴182上的对齐键214被容纳到形成于型式复制器械轴462中的对齐槽口474中。
和本文所述的许多其他器械一样,型式复制器械460包括形成于其轴462的外表面上的多个着色的深度标记482、484、486和488。和本文所述的其他深度标记(例如,起动器扩孔钻60的深度标记72、74、76和78、延伸工具120的深度标记172、174、176和178等等)不同,着色的深度标记482、484、486和488中的每一个不对应于各种近侧主体部件12中的一者的标准头部中心,而是对应于各种近侧主体部件12中的一者的肩部52的位置(参见图2)。例如,如上所述,近侧主体部件12可设置有四个不同的上部/下部长度- 75mm、85mm、95mm和105m。在本文所述的示例性实施例中,深度标记482是蓝色的且对应于75mm近侧主体部件12的肩部52的位置,深度标记484是绿色的且对应于85mm近侧主体部件12的肩部52的位置,深度标记486是黄色的且对应于95mm近侧主体部件12的肩部52的位置,且深度标记488是红色的且对应于105mm近侧主体部件12的肩部52的位置。深度标记482、484、486和488可体现为在型式复制器械460的轴462中雕刻出的沟槽,其中每一个填充有对应颜色的环氧树脂油墨。
型式复制器械460可由医用级金属构造,例如不锈钢、钴铬合金或钛,但可以使用其他金属或合金。此外,在一些实施例中,也可使用诸如聚醚醚酮(PEEK)之类的刚性聚合物。
现在参见图40-43,图中示出了稳杆器490。可将稳杆器490固定到近侧主体部件12,以防止所植入的模块化股骨假体10在锁定螺栓504的安装(参见图64-66)期间旋转。稳杆器490包括主体492,该主体具有延伸穿过其中的伸长镗孔494。驱动杆514被捕集在镗孔494中。驱动杆514的近端中形成有方形驱动头496,其相对的远端中形成有驱动承窝498。驱动承窝498的尺寸设定成容纳锁定螺栓504的头部502(参见图64)。因此,驱动杆514的驱动头496的旋转会使驱动承窝498旋转,因此使位于其中的锁定螺栓504的头部502旋转。
如图40和42所示,手柄506远离稳杆器490的主体492向上延伸。外科医生握住手柄506以防止在植入锁定螺栓504期间稳杆器490发生旋转(因此防止近侧主体部件12发生对应的旋转)。如在图40和42中所示,手柄506具有滚花的外表面。尤其是在存在外科手术期间常常存在的流体的情况下,这种有纹理的表面能够提高外科医生握紧手柄506的能力。
叉件508沿大致向下的方向远离稳杆器490的主体492延伸。如在下文中结合图64-66所述,当稳杆器490被安装在所植入的模块化股骨假体10上时,近侧主体部件12的伸长颈杆16被捕集在叉件508的叉齿510之间。因此,当外科医生防止稳杆器在锁定螺栓504的安装期间旋转时,所植入的模块化股骨假体10同样不能旋转,这是因为近侧主体部件12的伸长颈杆16被捕集在叉件508中。叉件508的叉齿510可被涂布或以其他方式覆盖非金属(如Radel)帽,以防止对近侧主体部件12的伸长颈杆16造成损伤。
稳杆器490可由医用级金属构造,例如不锈钢、钴铬合金或钛,但可以使用其他金属或合金。
现在参见图44-66,其显示外科手术,在所述外科手术中使用本文结合图7-43所述的各种器械,以对患者的股骨20进行手术准备,用于植入图1-6所示的股骨假体10。通常,股骨假体10作为修正手术的一部分而被植入。因此,外科手术从术前计划开始,在术前计划中,除其他事项之外,还可获得CT扫描或其他类型的术前图像,以计划现有股骨植入物的移除,连同修正股骨假体10的放置位置和取向。当术前计划结束后,解剖并收缩患者的软组织,以允许触及髋关节。通常实现对患者现有股骨假体的完全暴露(即,此前植入的假体现在被移除且由股骨假体10替代)。
然后,移除先前的股骨植入物。具体地讲,外科医生取出先前的股骨植入物,从而在患者的股骨20中的先前股骨植入物所放置的位置留出暴露的开口。然后外科医生对患者的股骨20的髓内腔22进行准备以容纳修正股骨假体10。起初,如图44所示,外科医生使用起动器扩孔钻60来对患者髓内腔22的植入远侧杆部件14的部分扩孔。为此,外科医生将起动器扩孔钻的近端64插入到手动手柄80(或任选地,旋转动力工具86)的卡盘中。接着,外科医生将起动器扩孔钻60的切割头66定位在患者的股骨20的髓内腔22中,然后旋转手柄80。手柄的这种旋转会使切割槽70以扩孔或换句话讲切割股骨的骨组织,从而获得畅通触及股骨腔的通道。如此触及髓内腔22可确保在后续的外科手术步骤期间修正股骨假体10的各部件适当地对齐。在本文所述的示例性实施例中,在进行远侧扩孔之前,可使用140mm长的起动器扩孔钻60来获得畅通触及股骨腔的通道。
如上所述,起动器扩孔钻刀柄62上的着色的深度标记72、74、76和78的每一个对应于多个不同近侧主体部件12的标准头部中心。例如,近侧主体部件12可设置有四个不同的长度- 75mm、85mm、95mm和105m。在本文所述的示例性实施例中,起动器扩孔钻60可被座置到85mm近侧主体的高度,以重新建立股骨头的旋转中心。这样做时,一个较短尺寸的近侧主体和两个较长的主体随后保持增大或减小腿部长度。因此,起动器扩孔钻60钻进患者的股骨20的髓内腔22中的更深处,直到深度标记74与更大的转子84的末端82对齐(参见图44)为止。在获得畅通触及患者的股骨20的髓内腔22的通道后,起动器扩孔钻60接着被移除。
接下来,外科医生利用远侧扩孔钻90来对患者髓内腔22的植入远侧杆部件14的部分扩孔。远侧扩孔钻90可产生具有容纳股骨假体10的远侧杆部件14所需的最终几何形状(即,形状)的镗孔。基于在术前制模过程期间所确定的远侧杆部件14的期望直径和长度,外科医生首先选择欲使用的适当尺寸的远侧扩孔钻90。具体地讲,如上所述,远侧扩孔钻90可被设置成具有四个不同的长度- 140mm、190mm、240mm和290mm,其中每一个对应于远侧杆部件14的可用长度中的一者。这些扩孔钻90被设置成以1mm的直径增量介于14mm至31mm之间。
根据患者的股骨20的髓内腔22的尺寸,外科医生选择具有适当大小的直径和长度的远侧扩孔钻90并将其附接到延伸工具120。为此,外科医生首先将延伸工具120的锁定杠杆158向下(沿图13的取向)拉动,以便将延伸工具120的驱动花键126定位到其回缩(即,解锁)位置。接着,外科医生通过远侧扩孔钻驱动连接器102的锁定槽口106的开口端而插入延伸工具120的锁定钳口148。然后,外科医生旋转延伸工具120,使得锁定钳口148被捕集在远侧扩孔钻的驱动连接器102的锁定槽口106中。这能在延伸工具120和所选的远侧扩孔钻90之间形成轴向稳定性。接着,外科医生将锁定杠杆158移动到其锁定位置(如图13所示),从而将驱动花键126移动到其延伸(即,锁定)位置,在该位置中,其被容纳到远侧扩孔钻的凹型驱动承窝108中。这可将远侧扩孔钻90锁定到延伸工具120,从而在延伸工具120和远侧扩孔钻90之间形成旋转稳定性。
随后将延伸工具120的凸型连接器134插入到旋转动力工具86的卡盘中。如图45所示,随后外科医生将远侧扩孔钻90的切割头96插入到患者的股骨20的髓内腔22中并启动动力工具86。动力工具86旋转远侧扩孔钻90,从而使其切割槽100以扩孔或换句话讲切割股骨20的骨组织。延伸工具120(其中远侧扩孔钻90固定该延伸工具)钻进患者的股骨20的髓内腔22中的更深处,直到期望的深度标记172、174、176和178与更大的转子84的末端82对齐为止。
接着从延伸工具120中移除初始的远侧扩孔钻90,并随后将具有下一更大直径和/或长度的扩孔钻90附接到延伸工具120并重复上述过程。外科医生用不断增大的远侧扩孔钻90来扩大直径和/或长度,直到与足够的皮质骨组织接合(被称为“良好的皮质颤动”)并获得适当的深度为止。
然后,外科医生可选择使用远侧扩孔钻90来执行试验手术。具体地讲,如果存在大的近侧畸形,且不存在传统的骨标志,则可对远侧扩孔钻90进行缩小,以获得例如对腿部长度和偏置的早期指示。在这种情况下,外科医生拉动延伸工具120上的锁定杠杆158,从而允许延伸工具120与仍位于患者的股骨20的髓内腔22中的远侧扩孔钻90脱离。然后,如图46所示,外科医生将近侧试验器械180固定到位于患者的股骨20的髓内腔22中的远侧扩孔钻。具体地讲,外科医生选择试验轴182,该试验轴对应于在远侧扩孔期间所参照的远侧扩孔钻深度(即,在扩孔期间基于所述远侧扩孔钻深度来利用深度标记172、174、176和178)。要插入试验轴182,外科医生使用试验杆插入工具430。具体地讲,外科医生将杆插入工具430的两个环436远离彼此推动,使得杠杆432围绕销434枢转,且保持承窝442的两半略微地远离彼此而伸展。试验轴182的杆204可随后被推进到保持承窝442的沟槽444中。然后,外科医生挤压或换句话讲将两个环436朝彼此推动,从而使杠杆432围绕销434枢转。这样做能将保持承窝442的两半朝彼此推动,从而挤压试验轴182的杆204,以便将试验轴182保持在保持沟槽442中。
接着,将试验轴182的远端插入到形成于远侧扩孔钻90的近端94中的埋头驱动连接器102中。这样做时,试验轴182的锁定螺纹194始于远侧扩孔钻90的螺纹112中。随后,外科医生将六角驱动器512(例如图56所示者)插入到试验轴的锁紧螺钉190的六角驱动头192中。然后,外科医生旋转六角驱动器512,以便旋转试验轴的锁紧螺钉190的远端中所形成的锁定螺纹194,从而将试验轴的螺纹194驱动到远侧扩孔钻90的螺纹112中。应当理解,六角驱动器512可体现为扭矩限制六角驱动器,以防止过度拧紧锁紧螺钉190。
如图46所示,可在将试验轴182联接到远侧扩孔钻90之前将试验颈杆184安装在试验轴182上。如果不事先安装,则可在将轴联接到远侧扩孔钻90之后将试验颈杆184安装在试验轴182上。为此,外科医生推进试验颈杆184,使得试验轴182的近侧杆204被容纳到试验颈杆184的镗孔228中。试验颈杆184在试验轴182的杆204上向下滑动,直到试验颈杆的主体224的下表面230接触形成于试验轴182的主体186中的肩部206(还可参见图14-17)为止。
此时,试验颈杆184可相对于试验轴182自由地活动。在将试验颈杆184取向为适当的型式时,可通过将手动的通用六角驱动器512(例如图56中所示者)插入到形成于试验颈杆的锁紧螺钉240的近端中的六角驱动头242中,而将所述试验颈杆固定在期望的位置。然后,外科医生可通过旋转六角驱动器512来拧紧锁紧螺钉240。由此,试验颈杆的摩擦夹钳238的锁定棘爪244被推动到试验轴182的花键表面208的沟槽中的一者的位置中。锁定棘爪244接触形成花键表面208的沟槽的侧壁,从而防止试验颈杆184相对于试验轴182旋转。应当理解,六角驱动器512可体现为扭矩限制六角驱动器,以防止过度拧紧锁紧螺钉240。
接着,外科医生将试验股骨头(未示出)安装到试验颈杆184上并执行试验复位,以确认适当的腿部长度、偏置和部件取向。一旦完成试验复位,就通过以上述方式将试验杆插入工具430联接到试验轴182来移除近侧试验器械180。随后,外科医生将六角驱动器512插入到试验轴的锁紧螺钉190的六角驱动头192中并沿与其在安装期间的旋转方向相反的方向旋转该六角驱动器,从而沿着使形成于试验轴的驱动轴122的远端中的锁定螺纹194离开远侧扩孔钻90的螺纹112的方向旋转所述锁定螺纹。接着可从远侧扩孔钻90移除近侧试验器械180。
当在未呈现大的近侧畸形的患者体内植入具有相对小的直径(如,14-20mm)的弓形远侧杆部件14时,可能需要使用修整锉刀290。如图48和49所示,外科医生可使用修整锉刀290来移除额外的骨,以便于适当地座置弓形远侧杆部件14。为使用修整锉刀290,外科医生首先将扩孔钻导引器轴250联接到仍位于患者的股骨20的髓内腔22中的远侧扩孔钻90(参见图47)。为此,将扩孔钻导引器轴250的远端布置在远侧扩孔钻90的近端94上。然后,外科医生通过将手动通用六角驱动器512(例如图56中所示者)插入到形成于扩孔钻导引器轴的锁紧螺钉256近端中的六角驱动承窝258中,而将扩孔钻导引器轴250固定到远侧扩孔钻90。接着,外科医生可旋转六角驱动器,以驱动扩孔钻导引器轴的锁紧螺钉256,从而将其螺纹260驱动到远侧扩孔钻90的螺纹112中。应当理解,六角驱动器512可体现为扭矩限制六角驱动器,以防止过度拧紧锁紧螺钉256。
随后,外科医生选择修整锉刀290,该修整锉刀的直径与在术前远侧扩孔操作期间所用的最终远侧扩孔钻90的直径相对应(此尺寸也对应于术前所确定的远侧杆部件14的尺寸)。接着,外科医生定位修整锉刀290,使得其导孔306的远端308位于扩孔钻导引器轴250的近端上方。然后推进修整锉刀290,使得扩孔钻导引器轴250进入修整锉刀290的导孔306。一旦插入到扩孔钻导引器轴250上方,外科医生就使用手柄294通过180°的摆动运动来回摆动修整锉刀290,从而使修整锉刀290的切割齿304沿两个方向研磨或换句话讲切割内侧皮质的多余骨组织。因此,逐渐形成具有容纳弓形远侧杆部件14所需的几何形状(即,形状)的凹口,且应被定位成相对于远侧杆部件顶点的计划位置成180°。当修整锉刀290完全就位时,修整锉刀的限深器312在扩孔钻导引器轴的锁紧螺钉256的驱动承窝258的上表面282上落到最低处(还可参见图22和23)。
在这样使用修整锉刀290期间,当扩孔钻导引器轴250沿锉刀的导孔306行进时,锉刀的观察窗314允许外科医生看到该扩孔钻导引器轴。这样做时,外科医生能通过透过形成于修整锉刀290中的观察窗314观察扩孔钻导引器轴250的着色标记280而在视觉上确认已实现对修整锉刀290的适当座置。具体地讲,当扩孔钻导引器轴250的着色标记280(其可透过观察窗314看见)与修整锉刀290的着色标记318对齐时,外科医生可在视觉上确认已实现对修整锉刀290的适当座置。
一旦完成修整操作,就从扩孔钻导引器轴250移除修整锉刀290。随后,通过以下方式将扩孔钻导引器轴250自身从远侧扩孔钻90移除:将手动通用六角驱动器512插入到形成于扩孔钻导引器轴的锁紧螺钉256近端中的六角驱动承窝258中,并沿与安装期间的旋转方向相反的方向旋转锁紧螺钉256,从而沿着使形成于锁紧螺钉256远端中的锁定螺纹260离开远侧扩孔钻90的螺纹112的方向旋转所述锁定螺纹。接着可从远侧扩孔钻90移除扩孔钻导引器轴250。
随后可从患者的股骨20的髓内腔22移除远侧扩孔钻。为此,外科医生以上述方式将延伸工具120联接到远侧扩孔钻90。然后,外科医生操作旋转动力工具86(或手动手柄80),以将远侧扩孔钻90退出患者的股骨20的髓内腔22。
一旦已移除远侧扩孔钻90,外科医生就可植入远侧杆部件14。为此,外科医生首先确保锥形件保护套筒380被安装在远侧杆部件14的上端中所形成的锥形柱30上。锥形件保护套筒380减少或甚至消除在后续的外科手术步骤期间对远侧杆部件14的锥形柱30的外表面的潜在损坏,从而提高远侧杆部件14和近侧主体部件12之间的锥形锁套的完整性。如上所述,锥形件保护套筒380可由制造商预先安装在远侧杆部件14上,因此外科医生无需对此予以额外关注。作为另外一种选择,如果锥形件保护套筒380在单独的无菌包装件中提供给外科医生,则外科医生从该单独的包装件中取出锥形件保护套筒380,并在植入之前将其安装到远侧杆部件14上。
然后,如图50所示,远侧杆部件14联接到杆插入工具330。外科医生将杆插入工具的对齐凹口350与对齐键44对齐,该对齐键从远侧杆部件14的主体38的上表面向上延伸。如上所述,对齐键44与远侧杆部件14的顶点对齐。远侧杆部件14相对于杆插入工具330被定位成使得对齐键44被容纳到杆插入工具远端中所形成的对齐凹口350。
接着,外科医生旋转杆插入工具330的旋钮340,以将其锁定杆338的锁定螺纹346插入到远侧杆部件14的上部螺纹40中(参见图6)。如上所述,上部螺纹40用于将远侧杆部件14联接到杆插入工具330和任何其他在植入杆部件期间承载负荷的外科器械。
如图51所示,外科医生随后将远侧杆部件插入到患者的股骨20的髓内腔22中。外科医生可使用外科锤(未示出)来击打旋钮340的上表面342,以将远侧杆部件14驱动到患者的股骨20的髓内腔22内的骨组织中。外科医生继续将远侧杆部件14驱动到患者的股骨20的髓内腔22中的更深处,直到杆插入工具330的期望深度标记372、374、376和378与更大转子84的末端82对齐为止(参见图51)。在如此植入远侧杆部件期间,位于杆插入工具330上的“APEX”标记提供对弓形远侧杆部件14顶点的位置的视觉指示器。这样,外科医生能够在患者的股骨20的髓内腔22中适当地取向弓形远侧杆部件14。
一旦已达到远侧杆部件14的期望植入深度,就移除杆插入工具330。为此,外科医生沿与安装期间的旋转方向相反的方向旋转杆插入工具330的旋钮340,从而沿着使形成于锁定杆338的远端中的锁定螺纹346离开远侧杆部件14的上部螺纹40的方向旋转所述锁定螺纹。随后,外科医生可从患者的股骨20的髓内腔22移除杆插入工具330。
在植入远侧杆部件14之后,外科医生接下来对患者的股骨20进行准备,以容纳近侧主体部件12。尽管可在远侧扩孔钻90上完成近侧主体准备,然而在所植入的远侧杆部件14上进行准备有利于实现最终的座置高度和杆的生物力学。锥形件保护套筒380在近侧主体准备期间保持固定到远侧杆部件14的锥形柱30。
如图53所示,外科医生可使用近侧扩孔钻390来移除额外的骨组织,以有利于适当地座置近侧主体部件12。为使用近侧扩孔钻390,外科医生首先将扩孔钻导引器轴250联接到所植入的远侧杆部件14(参见图52)。为此,外科医生将扩孔钻导引器轴的对齐平面264与对齐键44对齐,该对齐键从远侧杆部件14的主体38的上表面向上延伸。在这样做时,扩孔钻导引器轴250相对于远侧杆部件14被定位成使得扩孔钻导引器轴的对齐键284与远侧杆部件14的上表面内所形成的键槽46(参见图4)对齐并容纳到该键槽中,从而将扩孔钻导引器轴250的远端插入到由远侧杆部件的上部螺纹40形成的开口中。因此,扩孔钻导引器轴250的锁定螺纹260始于远侧杆部件14的下部螺纹42中。然后,外科医生通过将手动通用六角驱动器512(参见图56)插入到形成于扩孔钻导引器轴的锁紧螺钉256近端中的六角驱动承窝258中,而将扩孔钻导引器轴250锁定到远侧杆部件14。接着,外科医生可旋转六角驱动器,以驱动扩孔钻导引器轴的锁紧螺钉256,从而将螺纹260驱动到远侧杆部件14的下部螺纹42中。如上所述,六角驱动器512可体现为扭矩限制六角驱动器,以防止过度拧紧锁紧螺钉256。
外科医生接着选择近侧扩孔钻390的起始尺寸。在示例性实施例中,外科医生可选择具有20mm直径作为起始尺寸的近侧扩孔钻390。随后将所选的起始近侧扩孔钻390(如,20mm的近侧扩孔钻)的凸型连接器420插入到旋转动力工具86或手动手柄80的卡盘中。接着,外科医生定位近侧扩孔钻390,使得其导孔406的远端408位于扩孔钻导引器轴250的近端上方。然后推进近侧扩孔钻390,使得扩孔钻导引器轴250进入近侧扩孔钻390的导孔406。
一旦被插入到扩孔钻导引器轴250上方,外科医生就启动旋转动力工具86,以驱动(即,旋转)近侧扩孔钻390,从而使扩孔钻切割头396的螺旋形切割槽402研磨或换句话讲切割股骨20的骨组织。当近侧扩孔钻390完全就位时,近侧扩孔钻的限深器412在扩孔钻导引器轴250的锁紧螺钉256的驱动承窝258的上表面282上落到最低处(参见图22和23)。在这样使用修整锉刀近侧扩孔钻390期间,当扩孔钻导引器轴250沿扩孔钻的导孔406行进时,扩孔钻的观察窗414允许外科医生看到该扩孔钻导引器轴。这样做时,外科医生能通过透过形成于近侧扩孔钻390中的观察窗414观察扩孔钻导引器轴250的着色标记280而在视觉上确认已实现对近侧扩孔钻390的适当座置。具体地讲,当扩孔钻导引器轴250的着色标记280(其可透过观察窗414看见)与近侧扩孔钻390的着色标记418对齐时,外科医生可在视觉上确认已实现对近侧扩孔钻390的适当座置。
随后,外科医生移除具有起始尺寸(如,20mm直径)的近侧扩孔钻390,并用逐渐增大的近侧扩孔钻390来逐渐地对患者的股骨20进行扩孔,直到实现期望的皮质骨接触并且所扩孔的腔具有容纳外科医生所选近侧主体部件12所需的几何形状(即,形状)为止。
一旦完成近侧扩孔操作,就从股骨20移除具有最终期望尺寸的近侧扩孔钻390。随后,通过以下方式将扩孔钻导引器轴250自身从远侧杆部件14移除:将手动通用六角驱动器512(例如图56中所示者)插入到形成于扩孔钻导引器轴的锁紧螺钉256近端中的六角驱动承窝258中,并沿与安装期间的旋转方向相反的方向旋转锁紧螺钉256,从而沿着使形成于锁紧螺钉256远端中的锁定螺纹260离开远侧杆部件14的螺纹42的方向旋转所述锁定螺纹。接着可从远侧杆部件14移除扩孔钻导引器轴250。
如图54-56所示,一旦从远侧杆部件14移除扩孔钻导引器轴250,就可执行近侧主体试验手术。为此,外科医生首先将近侧试验器械180固定到植入在患者的股骨20的髓内腔22中的远侧杆部件14。具体地讲,外科医生选择试验轴182,该试验轴对应于在柄插入期间所参照的远侧杆深度(即,在柄插入期间基于所述远侧杆深度来利用深度标记372、374、376和378)。要插入试验轴182,外科医生使用试验杆插入工具430。具体地讲,外科医生将杆插入工具430的两个环436远离彼此推动,使得杠杆432围绕销434枢转,且保持承窝442的两半略微地远离彼此而伸展。试验轴182的杆204可随后被推进到保持承窝442的沟槽444中。然后,外科医生挤压或换句话讲将两个环436朝彼此推动,从而使杠杆432围绕销434枢转。这样做能将保持承窝442的两半朝彼此推动,从而挤压试验轴182的杆204,以便将试验轴182保持在保持沟槽442中。
接着将试验轴182的远端插入到所植入的远侧杆部件14的上端中。为此,外科医生将试验轴182的远端上所形成的对齐平面210与对齐键44对齐,该对齐键从远侧杆部件14的主体38的上表面向上延伸(参见图4)。在这样做时,形成于扩孔钻导引器轴182的远端中的对齐键214与形成于远侧杆部件14的上表面中的键槽46(参见图4)对齐并容纳到该键槽中,从而将试验轴182的远端插入到由远侧杆部件的上部螺纹40形成的开口中。因此,试验轴182的锁定螺纹194始于远侧杆部件14的下部螺纹42中。随后,外科医生将六角驱动器512(参见图56)插入到试验轴的锁紧螺钉190的六角驱动头192中。然后,外科医生旋转六角驱动器512,以便旋转试验轴的锁紧螺钉190的远端中所形成的锁定螺纹194,从而将试验轴的螺纹194驱动到远侧杆部件14的下部螺纹42中。一旦将试验轴182固定到远侧杆部件14,就移除试验杆插入工具430。如上所述,六角驱动器512可体现为扭矩限制六角驱动器,以防止过度拧紧锁紧螺钉190。
如图54和55所示,在将试验轴182联接到远侧杆部件14之前,可将试验颈杆184安装在试验轴182上。如果不事先安装,则可在将轴联接到远侧杆部件14之后将试验颈杆184安装在试验轴182上。为此,外科医生推进试验颈杆184,使得试验轴182的近侧杆204被容纳到试验颈杆184的镗孔228中。试验颈杆184在试验轴182的杆204上向下滑动,直到试验颈杆的主体224的下表面230接触形成于试验轴182的主体186中的肩部206(还可参见图14-17)为止。
如图57所示,在过程的此刻,试验颈杆184可相对于试验轴182自由地活动。在将试验颈杆184取向为适当的型式时,可通过将手动的通用六角驱动器512(例如图56中所示者)插入到形成于试验颈杆的锁紧螺钉240的近端中的六角驱动头242中,而将所述试验颈杆固定在期望的位置。然后,外科医生可通过旋转六角驱动器来拧紧锁紧螺钉240。由此,试验颈杆的摩擦夹钳238的锁定棘爪244被推动到试验轴182的花键表面208的沟槽中的一者的位置中。锁定棘爪244接触形成花键表面208的沟槽的侧壁,从而防止试验颈杆184相对于试验轴182旋转。如上所述,六角驱动器512可体现为扭矩限制六角驱动器,以防止过度拧紧锁紧螺钉240。
接着,外科医生将试验股骨头(未示出)安装到试验颈杆184上并执行试验复位,以确认适当的腿部长度、偏置和部件取向。如果需要在执行试验复位之后,外科医生可通过松动试验颈杆184的锁紧螺钉240、调整型式、以及随后重新拧紧锁紧螺钉240来重复该过程。一旦完成令外科医生满意的试验复位,就在无需将试验颈杆184从试验轴182解锁的情况下移除近侧试验器械180。换句话讲,在将近侧试验器械180从所植入的远侧杆部件14移除期间,保持试验颈杆184相对于试验轴182的取向(即,器械的型式)。要在不扰乱试验颈杆184相对于试验轴182的取向(即,器械的型式)的情况下移除近侧试验器械180,以上述方式将试验插入器具430联接到试验轴182。随后,外科医生将六角驱动器512插入到试验轴的锁紧螺钉190的六角驱动头192中并沿与其在安装期间的旋转方向相反的方向旋转该六角驱动器,从而沿着使形成于试验轴的驱动轴122的远端中的锁定螺纹194离开所植入的远侧杆部件14的下部螺纹42的方向旋转所述锁定螺纹。接着可将近侧试验器械180从远侧杆部件14移除,并保持其试验产生的形式仍不受损。
如图58-61所示,可利用型式复制器械460将使用近侧试验器械180通过近侧试验手术所形成的型式复制到近侧主体部件12。首先,外科医生移除锥形件保护套筒380,以便暴露形成于远侧杆部件14的上端中的锥形柱30。然后外科医生检查锥形柱30以确保其是干的且没有碎屑。如果需要清洗,则通过加压盐水溶液冲洗来洗涤锥形柱30,并随后完全干燥。
型式复制器械460可接着联接到所植入的远侧杆部件14。为此,外科医生将形成于型式复制器械460远端中的对齐键468与形成于远侧杆部件14上表面中的键槽46(参见图4)对齐,并将型式复制器械460的远端插入到由远侧杆部件的上部螺纹40所形成的开口中。如在图58中所示,随后可将近侧主体部件12安装到型式复制器械460上。为此,外科医生推进近侧主体部件12,使得型式复制器械460被容纳到近侧主体部件12的锥形镗孔28中。接着,近侧主体部件12沿型式复制器械460向下滑动,使得远侧杆部件14的锥形柱30被容纳到其锥形镗孔28中。
随后,在试验轴182和试验颈杆184仍被锁定于近侧试验期间所确定的形式中(参见图54-57)的情况下,将近侧试验器械180联接到型式复制器械460的近端。具体地讲,如图60和61所示,将近侧试验器械180的试验轴182的远端212(参见图14-16)插入到形成于型式复制器械460近端中的盲孔470中。这样做时,形成于近侧试验器械180的试验轴182上的对齐键214被容纳到形成于型式复制器械轴462中的对齐槽口474中。
随后可旋转近侧主体部件12以与近侧试验器械180的型式相匹配。也就是说,外科医生可沿型式复制器械460的纵向轴线向下看并旋转近侧主体部件12,以使得其颈杆16与试验颈杆184的伸长颈杆226对齐。因此,近侧主体部件12被放置成与近侧试验期间所获得的型式(参见图54-57)相同的型式。一旦近侧试验器械180的型式在近侧主体部件12的位置中被复制,就接着将近侧试验器械180提起离开型式复制器械460的近端。
如图62和63所示,一旦移除近侧试验器械180,锥形夯540就可在型式复制器械460上滑动。如在图62中所示,锥形夯540具有形成于其中的伸长的盲孔542。孔542的尺寸设定成使得在使用夯540期间锥形夯540的远侧边缘544接触近侧主体部件12的肩部52而不干扰型式复制器械460。换句话讲,一旦在型式复制器械460上滑动,外科医生就用外科锤轻轻地敲打锥形夯540,以在型式复制器械460在孔542中不落到最低处的情况下初始地接合远侧杆部件14和近侧主体部件12之间的锥形锁套连接部。如上所述,一旦被植入,型式复制器械460上的着色的深度标记482、484、486和488中的每一个就对应于近侧主体部件12的肩部52的位置。因此,着色的深度标记482、484、486和488可用作深度标记,以确保在移除型式复制器械460之前,远侧杆部件14的锥形柱30和近侧主体部件12的锥形镗孔28不会显著地脱位。接着移除锥形夯540和型式复制器械460。接着,外科医生使用锥形件组装工具(例如2010年6月15日提交的美国专利申请序列号12/815,915中所述的锥形件组装工具)来完全接合远侧杆部件14和近侧主体部件12之间的锥形锁套连接部。
随后,外科医生获得具有适当尺寸的锁定螺栓504。图67-70中为更详细地示出了锁定螺栓504。如该图所示,锁定螺栓504具有远离其头部502延伸的刀柄524。刀柄524具有形成于其中的多个外部螺纹526。锁定螺栓的螺纹526小于远侧杆部件14的上部螺纹40,使得锁定螺栓的螺纹在锁定螺栓504的安装期间无需螺纹接合便从所述上部螺纹经过。相反,锁定螺栓的螺纹526的尺寸设定成与远侧杆部件14的下部螺纹42进行螺纹接合。因此,在本文所述的示例性实施例中,锁定螺栓的螺纹526体现为M6螺纹。此外,和远侧杆部件14的下部螺纹42一样,锁定螺栓的螺纹526体现为专用于释放应力梯级的改进型螺纹。具体地讲,如在图68-69中最佳示出,锁定螺栓的螺纹526体现为经修改的MJ6 × 1.0磨制螺纹。
阶梯状的垫圈528被安装在锁定螺栓504上。阶梯状的垫圈528用作偏置构件,以抵抗锁定螺栓504在安装时松动。如在图67-70中所示,螺栓头部502的凸缘用作对阶梯状垫圈528的压缩器。在安装之前,夹子530将阶梯状垫圈528保持在锁定螺栓504的刀柄524上。
锁定螺栓504和阶梯状垫圈528均可由医用级金属构造,例如不锈钢、钴铬合金或钛,但可以使用其他金属或合金。夹子530可由刚性聚合物构造,例如聚醚醚酮(PEEK)。
再次参见图64,一旦外科医生获得具有适当尺寸的锁定螺栓504,随后就安装锁定螺栓504以用作近侧主体部件12和远侧杆部件14之间的副锁。为此,外科医生穿过近侧主体部件12的埋头腔32插入锁定螺栓504(参见图64)。然后,外科医生用指压转动锁定螺栓504,从而在锁定螺栓504的螺纹526与远侧杆部件14的下部螺纹42之间形成初始螺纹接合。接着,外科医生对锁定螺栓504施加预定的扭矩。为此,外科医生使用稳杆器490结合扭矩扳手(例如图65和66中所示的T形手柄的扭矩扳手520)。如图65所示,外科医生首先将扭矩扳手52的驱动承窝522联接到形成于稳杆器的驱动杆514近端中的方形驱动头496。一旦以此种方式联接,扭矩扳手520的旋转就会使稳杆器的驱动杆514旋转,并因此驱动形成于远端中的驱动承窝498。
固定有扭矩扳手520的稳杆器490随后被组装在所植入的股骨假体10上。具体地讲,外科医生推进稳杆器490与股骨假体10接触,使得锁定螺栓504的头部502被容纳到稳杆器的驱动杆514的驱动承窝498中,且近侧主体部件12的伸长颈杆16被捕集在稳杆器的叉件508的叉齿510之间(参见图66)。
一旦稳杆器490以上述方式被固定到所植入的股骨假体10,外科医生就拧紧锁定螺栓504。具体地讲,外科医生转动T形手柄的扭矩扳手520直至其发出卡嗒声。听到这种卡嗒声表明已对锁定螺栓504施加适当的扭矩,从而使外科医生确认锁定螺栓504已完全就位。随后从所植入的股骨假体10上移除固定有扭矩扳手520的稳杆器490。
如果出于某种原因外科医生需要解除远侧杆部件14和近侧主体部件12之间的锥形锁套连接部,则外科医生可使用锥形件拆卸工具,例如2010年9月1日提交的美国专利申请序列号12/873,612中所述的锥形件拆卸工具。在使用这种拆卸工具之前,外科医生首先移除锁定螺栓504。
现在参见图71-73,其中示出试验杆插入工具630的另一种实施例,该试验杆插入工具可固定到近侧试验器械180,以利于将其附接到被植入在患者的股骨20的髓内腔22中的远侧扩孔钻90或远侧杆部件14。试验杆插入工具630包括主体632,该主体具有延伸穿过其中的伸长镗孔634。套筒636定位在杆插入工具的主体632周围。套筒636例如通过重叠注塑而不可移动地联接到杆插入工具主体632的外表面。套筒636用作夹持件,以允许外科医生在将近侧试验器械180组装到远侧扩孔钻90或远侧杆部件14期间握住试验杆插入工具630。
驱动杆638被捕集在镗孔634中。旋钮640被固定到驱动杆638的近端。旋钮640的旋转会使驱动杆638旋转。驱动杆638包括位于其远端处的六角驱动末端652(参见图72和73)。当六角驱动末端652位于近侧试验轴182的六角驱动头192中并旋转时,形成于试验轴的驱动轴122的远端中的锁定螺纹194同样地旋转。如上所述,试验轴的驱动轴122的这种旋转会将驱动轴的螺纹194驱动到远侧杆部件14的下部螺纹42中或远侧扩孔钻90的螺纹112中。
试验杆插入工具630的主体632的远端具有形成于其中的保持承窝642。保持承窝642的尺寸和形状设定成容纳形成于试验轴182的近端202中的杆204。具体地讲,如图73的剖视图所示,保持承窝642具有形成于其中的圆形沟槽644。沟槽644的内径被设定成紧密地模仿试验轴182的杆204的外径的尺寸,以便将该杆容纳在沟槽中。如在图73的剖视图中所示,保持承窝642具有延伸穿过其中的对齐销646。对齐销646大致垂直于试验杆插入工具630的纵向轴线而设置。对齐销646基本上“压扁”圆形沟槽644的一侧。对齐销646沿相对于试验杆插入工具630的期望取向对齐近侧试验器械180的试验轴182。
如在图72的剖视图中所示,固位环648定位在限定试验杆插入工具保持承窝642的沟槽644的侧壁650中。固位环648搭锁在试验轴182的杆204外表面上的沟槽周围,以将近侧试验器械180的试验轴182保持在保持承窝642中。
试验杆插入工具630的金属部件(如,杆插入工具的主体632、驱动杆638等等)可由医用级金属构造,例如不锈钢、钴铬合金或钛,但可以使用其他金属或合金。此外,在一些实施例中,也可使用诸如聚醚醚酮(PEEK)之类的刚性聚合物。套筒636可由例如迭尔林或硅树脂等聚合物构造。
尽管在附图和上述说明中已详细地举例说明和描述了本公开,但此类图示和描述应视为示例性的而不是限制性的,应当理解的是,仅示出和描述了示例性的实施例,并且本发明实质范围内的所有改变和变型都应受到保护。
本发明具有从本文所述装置、系统和方法的多个特征而产生的多个优点。应当注意的是,本发明的装置、系统和方法的替代实施例可能不包括所述的所有特征,但仍然可以受益于这些特征的优点中的至少一些。本领域的普通技术人员可以容易地设计出其自己装置、系统和方法的实施方式,该实施方式可整合本发明特征中的一项或多项,并且落在本发明的实质和范围内。

Claims (18)

1.一种用于在外科手术期间植入整形髋关节假体的外科器械组件,包括:
型式复制器械,所述型式复制器械包括伸长轴,所述伸长轴具有(i)对齐键,所述对齐键形成于所述伸长轴的远端中,所述对齐键具有纵向轴线,和(ii)对齐槽口,所述对齐槽口形成于所述伸长轴的相对的近端中,所述对齐槽口具有与所述对齐键的纵向轴线位于同一假想线上的纵向轴线,和
近侧试验器械,包括:
第一部件,具有形成于其外表面中的对齐键,所述第一部件具有纵向轴线,
第二部件,其枢转联接至所述第一部件以允许所述第二部件围绕所述第一部件的纵向轴线旋转,所述第二部件包括配置成容纳股骨头试验件的颈杆,
其中,(i)所述伸长轴的近端中限定孔,所述孔沿平行于所述对齐槽口和所述对齐键的纵向轴线的方向延伸,并且(ii)所述对齐槽口向内延伸穿过所述伸长轴的外表面且通向所述孔中,并且
其中,当所述近侧试验器械固定到所述型式复制器械时,所述近侧试验器械的对齐键定位在所述型式复制器械的对齐槽口中,以便使所述近侧试验器械在相对于所述型式复制器械的预定取向上对齐。
2.根据权利要求1所述的外科器械组件,其中,所述对齐键包括从所述伸长轴的远端向外延伸的伸长肋。
3.根据权利要求1所述的外科器械组件,其中,所述对齐键具有瓣状横截面形状。
4.根据权利要求1所述的外科器械组件,其中,所述孔包括形成于所述伸长轴的近端中的盲孔。
5.根据权利要求1所述的外科器械组件,其中,所述型式复制器械的对齐键配置成与形成于远侧杆部件的上表面中的键槽配合,以便当所述型式复制器械固定到所述远侧杆部件时使所述型式复制器械在相对于所述远侧杆部件的预定取向上对齐。
6.一种用于在外科手术期间植入整形髋关节假体的外科器械组件,所述外科器械组件包括:
型式复制器械,所述型式复制器械包括伸长轴,所述伸长轴具有(i)对齐键,所述对齐键形成于所述伸长轴的远端中,所述对齐键具有纵向轴线,和(ii)对齐槽口,所述对齐槽口形成于所述伸长轴的相对的近端中,所述对齐槽口具有与所述对齐键的纵向轴线位于同一假想线上的纵向轴线,和
近侧试验器械,包括:
第一部件,具有形成于其外表面中的对齐键,所述第一部件具有纵向轴线,
第二部件,其枢转联接至所述第一部件以允许所述第二部件围绕所述第一部件的纵向轴线旋转,所述第二部件包括配置成容纳股骨头试验件的颈杆,
其中,当所述近侧试验器械固定到所述型式复制器械时,所述近侧试验器械的对齐键定位在所述型式复制器械的对齐槽口中,以便使所述近侧试验器械在相对于所述型式复制器械的预定取向上对齐。
7.根据权利要求6所述的外科器械组件,其中,所述型式复制器械的对齐键包括从所述伸长轴的远端向外延伸的伸长肋。
8.根据权利要求6所述的外科器械组件,其中,所述型式复制器械的对齐键具有瓣状横截面形状。
9.根据权利要求6所述的外科器械组件,其中:
所述伸长轴的近端具有形成于其中的孔,
所述孔沿平行于所述伸长轴的纵向轴线的方向延伸,并且
所述对齐槽口通向所述孔中。
10.根据权利要求9所述的外科器械组件,其中,所述孔包括形成于所述伸长轴的近端中的盲孔。
11.根据权利要求6所述的外科器械组件,其中,所述型式复制器械的对齐键配置成与形成于远侧杆部件的上表面中的键槽配合,以便当所述型式复制器械固定到所述远侧杆部件时使所述型式复制器械在相对于所述远侧杆部件的预定取向上对齐。
12.一种用于在外科手术期间植入整形髋关节假体的外科器械组件,所述外科器械组件包括:
型式复制器械,所述型式复制器械包括伸长轴,所述伸长轴具有(i)对齐键,所述对齐键形成于所述伸长轴的远端中,所述对齐键具有纵向轴线,(ii)对齐槽口,所述对齐槽口形成于所述伸长轴的相对的近端中,所述对齐槽口具有与所述对齐键的纵向轴线位于同一假想线上的纵向轴线,和(iii)多个沟槽,其形成在所述伸长轴的外表面中且定位在所述对齐键与所述对齐槽口之间,和
近侧试验器械,包括:
第一部件,具有形成于其外表面中的对齐键,所述第一部件具有纵向轴线,
第二部件,其枢转联接至所述第一部件以允许所述第二部件围绕所述第一部件的纵向轴线旋转,所述第二部件包括配置成容纳股骨头试验件的颈杆,
其中,当所述近侧试验器械固定到所述型式复制器械时,所述近侧试验器械的对齐键定位在所述型式复制器械的对齐槽口中,以便使所述近侧试验器械在相对于所述型式复制器械的预定取向上对齐。
13.根据权利要求12所述的外科器械组件,其中,(i)所述伸长轴的近端具有形成于其中的孔,(ii)所述孔沿平行于所述伸长轴的纵向轴线的方向延伸,并且(iii)所述对齐槽口在垂直于所述轴的纵向轴线的方向上延伸穿过所述伸长轴的外表面以通向所述孔中。
14.根据权利要求12所述的外科器械组件,其中,所述对齐键包括从所述伸长轴的远端向外延伸的伸长肋。
15.根据权利要求12所述的外科器械组件,其中,所述对齐键具有瓣状横截面形状。
16.根据权利要求12所述的外科器械组件,其中:
所述伸长轴的近端具有形成于其中的孔,
所述孔沿平行于所述伸长轴的纵向轴线的方向延伸,并且
所述对齐槽口通向所述孔中。
17.根据权利要求16所述的外科器械组件,其中,所述孔包括形成于所述伸长轴的近端中的盲孔。
18.根据权利要求12所述的外科器械组件,其中,所述型式复制器械的对齐键配置成与形成于远侧杆部件的上表面中的键槽配合,以便当所述型式复制器械固定到所述远侧杆部件时使所述型式复制器械在相对于所述远侧杆部件的预定取向上对齐。
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