CN103402463B - 用于脊椎稳定的体内装置和板及定位该装置和板的器械 - Google Patents

用于脊椎稳定的体内装置和板及定位该装置和板的器械 Download PDF

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Publication number
CN103402463B
CN103402463B CN201280010956.9A CN201280010956A CN103402463B CN 103402463 B CN103402463 B CN 103402463B CN 201280010956 A CN201280010956 A CN 201280010956A CN 103402463 B CN103402463 B CN 103402463B
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China
Prior art keywords
plate
implant
relative
pair
socket
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CN201280010956.9A
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CN103402463A (zh
Inventor
W·D·阿姆斯特朗
T·A·卡尔斯
J·A·考恩
J·P·邓肯
R·A·海因斯
A·J·麦尔肯特
J-P·穆巴塞尔
M·D·H·西尔科克斯三世
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Warsaw Orthopedic Inc
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Warsaw Orthopedic Inc
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    • A61F2/00Filters 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
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    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/447Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
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    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7059Cortical plates
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    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
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Abstract

本发明提供了用于在第一和第二椎骨之间提供稳定的系统、方法和装置。具体来说,在一种形式中,系统包括植入物和独立板,植入物构造成定位在第一和第二椎骨之间的脊椎盘空间内,而独立板用于与第一和第二椎骨的脊椎盘外表面接合。该系统还包括带有接合部分的插入器械,该接合部分构造成可释放地与植入物和板相接合,这样,植入物和板可一起相对于第一和第二椎骨定位。在一个方面,当用器械使植入物和板接合时,植入物相对于板的角度定向可以调整。在该方面或另一方面,当植入物和板通过器械接合时,植入物和板保持邻近的关系。然而,也可考虑不同的形式和应用。

Description

用于脊椎稳定的体内装置和板及定位该装置和板的器械
技术领域
本申请总地涉及包括体内植入装置和相关支承板的脊椎稳定,并还涉及相对于脊柱一起插入和定位植入装置和支承板的器械和方法。
背景技术
为了矫正和稳定脊椎和便于脊椎不同高度处的融合,人们已经开发出好几种技术和系统。某些技术和系统包括将一个或多个体内植入物定位在相邻椎骨之间的脊椎盘空间内。当植入物放置到脊椎盘空间内时,植入物进入脊椎盘空间所采取的通道或路径,提供了让植入物从脊椎盘空间作倒退运动的路径。在某些形式中,可用板来阻止植入物的倒退运动,和/或对相邻的椎骨提供附加的稳定性。如果采用板的话,则通常在植入物植入之后的单独外科手术步骤中,将板定位成与相邻椎骨相接合。植入物也可在植入之前先附连到板上,但如此的附连会限制植入物和板为适应椎骨的脊椎解剖学的各个方面而进行彼此调整的可调性,和/或增加外科手术的时间和复杂性。
因此,在包括体内植入装置和相关支承板的脊椎稳定方面,以及插入和定位植入装置和支承板的器械和方法方面,仍需作进一步的改进。
发明内容
本发明提供用于脊椎稳定的体内植入物和相关的支承板,以及相对于脊柱一起插入和定位植入物和支承板的器械和技术。具体来说,在一种形式中,系统包括植入物和独立板,植入物构造成定位在第一和第二椎骨之间的脊椎盘空间内,而独立板用于与第一和第二椎骨接合。该系统还包括带有接合部分的插入器械,该接合部分构造成可释放地与植入物和板相接合,这样,在单一外科步骤中,便可相对于第一和第二椎骨一起定位植入物和板。在一个方面,当用器械使植入物和板接合时,植入物相对于板的角度定向可以调整。在该方面或另一方面,当植入物和板通过器械接合时,植入物和板保持邻近的关系。然而,也可考虑不同的形式和应用。
在一个实施例中,提供脊椎稳定的系统包括植入物,该植入物包括从前端延伸到相对的尾端的本体。该本体还包括上骨接合表面和相对的下骨接合表面,当植入物定位在上和下椎骨之间的脊椎盘空间内时,上和下骨接合表面接合上和下椎骨相应的端板。该系统还包括与上和下椎骨接合的板。该板包括在上端和相对的下端之间延伸的本体,该板本体包括顶表面和相对的底表面,当板与上和下椎骨接合时,两个表面面对上和下椎骨。插入器械包括接合部分,该接合部分构造成可释放地与植入物和板相接合,这样,当植入物和板通过器械接合时,植入物相对于板的角度定向可调整。
在另一实施例中,提供脊椎稳定的系统包括植入物,该植入物包括从前端延伸到相对的尾端的本体。该本体还包括上骨接合表面和相对的下骨接合表面,当植入物定位在上和下椎骨之间的脊椎盘空间内时,上和下骨接合表面接合上和下椎骨相应的端板。该系统还包括与上和下椎骨接合的板,该板包括在上端和相对的下端之间延伸的本体。该板本体还包括近端表面、相对的远端表面,以及面向远端的中间部分,该中间部分构造成与植入物的尾端配合。插入器械包括接合部分,该接合部分构造成可释放地与植入物和板相接合,这样,当植入物和板通过器械接合时,植入物和板保持邻近的关系,一旦脱开与器械接合,植入物便从板移位。
在还有另一实施例中,提供第一和第二椎骨之间脊椎稳定的方法包括提供植入物,该植入物包括从前端延伸到相对的尾端的本体,该本体还包括上骨接合表面和相对的下骨接合表面。该方法还包括提供用于与第一和第二椎骨接合的板。该板包括延伸在上端和相对的下端之间的本体。该方法的其它步骤包括使插入器械与植入物和板接合,其包括将植入物和板保持在邻近的、脱开偶联的结构中;用插入器械将植入物的前端插入在第一和第二椎骨之间的脊椎盘空间内,并将植入物推进到脊椎盘空间内,直到板的底表面接触第一和第二椎骨的脊椎盘外的表面。该实施例的另一方面包括:当插入器械与植入物和板接合且植入物和板保持在邻近的、脱开偶联的结构中时,相对于板来转动植入物。还有,该实施例的另一方面包括沿着通过插入器械和板的对应导向孔导向至少一个紧固件,以与其中一个椎骨接合。
其它的实施例包括独特的方法、技术、系统、装置、成套工具、组件、设备,和/或结合第一和第二椎骨的稳定和支承一起使用的装置。然而,在其它的实施例中,也可考虑不同的形式和应用。
从详细描述和随描述提供的附图中,本申请的其它实施例、形式、特征、方面、益处、目的和优点将会变得明白。
附图说明
图1是示意的平面图,使某些特征显示为剖视图,其朝向脊柱的椎骨体端板的轴向平面观看,体内植入物和板相对于端板定位。
图2是示意的立面图,其朝向脊柱的椎骨高度处的矢状平面观看,该脊柱包括图1的椎骨体、体内植入物和板。
图3是图1所示体内植入物的俯视平面图。
图4是图1所示体内植入物的侧视平面图。
图4A和4B是另一替代实施例的体内植入物的侧视平面图。
图5是图1所示体内植入物的立体图。
图6是图1所示板的前视平面图。
图7和8是图1所示板的相对的侧视平面图。
图9是一个实施例的插入器械的平面图,该插入器械构造成相对于脊柱插入和定位图1的体内植入物和板。
图10是围绕器械纵向轴线转过90度的图9所示插入器械的平面图。
图11是围绕器械纵向轴线转过180度的图9所示插入器械远端的平面图。
图12是沿视图线12-12截取的图9所示插入器械近端的剖视图。
图13是图9所示器械内部构件的平面图。
图14是沿视图线14-14截取的图13所示内部构件的剖视图。
图15是图13所示内部构件远端的立体图。
图16是图9所示器械的外部构件的平面图。
图17是沿视图线17-17截取的图16所示外部构件的剖视图。
图18是与图1的体内植入物和板接合的图9所示器械的平面图。
图19是另一个替代实施例的插入器械的平面图,该插入器械构造成相对于脊柱插入和定位图1的体内植入物和板。
图20是围绕器械纵向轴线转过90度的图19所示插入器械的平面图,其中,某些特征显示为沿着视图线20-20截取的剖视图。
具体实施方式
为了便于理解本发明的原理,现将参照附图中所示的实施例,并用特殊的语言来描述它们。然而,应该理解到,由此并不意图限制本发明的范围。在所示装置和描述的方法中,任何如此替代做法和进一步的修改,以及如文中所说明的本发明原理的任何如此的其它应用,通常都会被与本发明相关的技术领域内的技术人员所想到。
提供各种方法、技术、器械、装置和植入物,用以恢复和/或将坍瘪的、部分坍瘪的、损坏的、疾患的,或其它功能减弱的脊椎盘空间保持在要求的脊椎盘空间高度处和邻近端板的定向。该器械和植入物可用在使用微创入侵的器械的技术中,以及可用于进入脊椎盘空间的技术,但也可考虑在非微创手术的进入。进入到坍瘪脊椎盘空间可以是单入口、双入口或多入口方式。器械和植入物也可用于直接的前接近到脊椎盘空间,但也可考虑其它的接近方法,包括侧向的、前-侧向、后-侧向、斜向和后接近方法。还有,外科方法、技术、器械和植入物可在所有脊椎的脊骨段处找到应用,包括腰椎、胸椎和颈椎区域。
在一个方面,提供用于脊椎稳定的体内植入物和相关的支承板,以及相对于脊柱一起插入和定位植入物和支承板的器械和技术。具体来说,在一种形式中,系统包括植入物和独立板,植入物构造成定位在第一和第二椎骨之间的脊椎盘空间内,而独立板用于与第一和第二椎骨接合。该系统还包括带有接合部分的插入器械,该接合部分构造成可释放地与植入物和板相接合,这样,在单一外科步骤中,便可相对于第一和第二椎骨一起定位植入物和板。在一个方面,当用器械使植入物和板啮合时,植入物相对于板的角度定向可调整。在该方面或另一方面,当植入物和板通过器械接合时,植入物和板保持邻近的关系。然而,也可考虑不同的形式和应用。
现在总地参照图1,该图示出了平面图,使某些特征显示为剖视图,其朝向椎骨体V1的轴向平面尾端地观看。如图1和2所示,脊椎体内植入物10定位在脊骨体V1、V2之间的脊椎盘内的脊骨端板E1上,用多个骨接合紧固件,将板12基本上在脊椎盘外,或在盘空间外固定到脊骨体V1、V2,其中两个紧固件显示为骨螺钉14、16的形式。在所示的形式中,一部分板12还延伸在脊骨体V1、V2之间,但也可考虑这样的形式,其中,板12完全定位在脊椎盘外,板没有延伸在脊骨体V1、V2之间的部分。脊骨体V1连同脊骨体V2以及脊椎盘空间D包括位于颈椎区域的脊柱段SC,但如上所述,植入物10和板12在胸椎和腰椎区域的植入也是可能的和可以想到的。植入物10定位在脊骨体V1、V2之间的脊椎盘空间D内,这样,当植入物处于其植入的定向时,它接触端板E1和E2。在所示的形式中,板12定位成沿着脊骨体V1、V2面向前的表面躺着,但也可考虑板12沿着脊骨体V1、V2的交替面向的表面定位,这根据植入物10对脊骨体V1、V2的定向而定。类似地,在所示的形式中,脊骨体V1、V2可从前面接近方式进入,但侧向的、前-侧向、后-侧向、斜向和后接近方法也是可能的。此外,如图所示,植入物10和板12一般地彼此邻近和彼此邻接接合的方式定位,但应该认识到,由于植入物10和板12实体上彼此不附连,或其它方式彼此偶联,这将在下面作详细讨论,所以,植入物10远离板12的运动也是可能的。
现在总地参照图3-5,植入物10包括本体18,其尺寸适于配合在邻近脊骨体V1、V2之间的脊椎盘空间D内。本体18从前端20延伸到相对的尾端22。在所示的形式中,前端20通常包括定位在倾斜表面26、28之间的平面表面24,倾斜表面可便于植入物10插入到脊椎盘空间D内,和/或分开脊骨体V1、V2。在其它未图示的形式中,前端20可包括凸出的倒圆鼻部,以便于植入物插入到脊椎盘空间D内和分开脊骨体V1、V2。例如,如图3所示,本体18还包括插座23,X光线照相标记物可定位在该插座内,以便于植入物10在图像引导下放置在脊骨体V1、V2之间。
本体18还包括上和下骨接合表面30、32,它们带有突脊34、36(其中只有几个示出,以保持其清晰起见),以提高与脊骨端板E1和E2的接合。在其它形式中,上和下骨接合表面30、32可设置有螺纹、槽、齿形压花纹或其它表面粗糙形式,这里仅提供几个可能性,目的在于提高与脊骨端板E1和E2的接合。在所示形式中,骨接合表面30包括介于前端20和尾端22之间的大致凸出的结构,而骨接合表面32包括介于前端20和尾端22之间的大致平面的或直的结构。在其它形式中,应该认识到,骨接合表面30也可以是平面的,而骨接合表面32也可以是凸出弧形的。还有,骨接合表面30、32在前端20和尾端22之间的构造上的变化都是可能的。此外,骨接合表面30、32大致构造成:植入物10被接纳在端板E1和E2之间,并沿着本体18的至少一部分内与端板E1和E2的至少一部分内接触。本体18还包括从前端20延伸到尾端22并还从骨接合表面30延伸到骨接合表面32的相对的侧壁38、40。侧壁38、40可彼此平行,或相对于彼此成锥度,以朝向前端20汇聚或发散。侧壁38、40从前端20至尾端22可以是平面的、凹陷的或凸出的,从骨接合表面30至骨接合表面32可以是凹陷的或凸出的,或者是它们的组合。
本体18还包括通过骨接合表面30、32敞开的空穴42,以便于骨通过本体18生长,但不存在空穴42的形式也是可能的。在其它未示出的形式中,可以考虑,本体18还可包括一个或多个开口,它们延伸通过侧壁38、40和/或前端和尾端20、22并与空穴42连通。此外,尽管未予示出,但应该认识到,可将一个或多个生物相容的材料定位在空穴42内,例如,该生物相容材料提供治疗的效果或提高骨通过植入物10的生长。如此生物相容材料的实例可包括:磷酸钙、羟磷灰石-磷酸三钙(HA-TCP)混合物、生物活性玻璃、硫酸钙骨隙填料、胶原质、血纤维蛋白、白蛋白、卡拉蛋白(karatin)、丝、弹性蛋白、去矿化骨基质、颗粒骨、充质(mysenchymal)干细胞、荷尔蒙、诸如转化生长因子β(TGFb)蛋白、骨形态发生基因蛋白(包括BMP和BMP2)之类的生长因子,或血小板衍生出的生长因子,这里只是提供几种可能性。在一个方面,生物相容材料在纳入时可分别在骨接合表面30、32上面和下面略微地延伸,以便于邻近的脊骨体将压缩荷载施加到生物相同材料上和通过生物相容材料。
例如,如图4所示,植入物10的尾端22大致在骨接合表面30、32之间呈凸出弧形。此外,尾端22还包括细长狭槽44,其定位在骨接合表面30、32之间并延伸在侧壁38、40之间,但在其它形式中,应该认识到,尾端22可不设置有细长狭槽44。本体18还包括第一插座46,其形成在侧壁38内并大致地包括圆形结构,该结构构造成接纳插入器械的对应构造部分,其进一步的细节将在下文中提供。本体18还包括形成在侧壁38内的槽口或槽47。槽47包括上和下表面48、50以及面向侧面的表面52、54,槽47延伸通过尾端22而与第一插座46连通。在所示的形式中,上和下表面48、50大致布置成相对于彼此呈倾斜定向,但也可考虑其它的形式。本体18还包括形成在侧壁40内的第二插座56,其大致包括圆形结构,该结构构造成接纳插入器械的对应构造部分,其进一步的细节将在下文中提供。本体18还包括形成在侧壁40内的槽口或槽57。槽57包括上和下表面58、60,以及延伸通过尾端22而与第二插座56连通。在所示的形式中,上和下表面58、60大致布置成相对于彼此呈倾斜定向,但也可考虑其它的形式。
尽管前面未予讨论,但应该认识到,允许接纳插入器械的对应构造部分的插座46、56的大致圆形结构,在植入物10和板12通过插入器械接合时,使得植入物10相对于板12的角度定向可调整,其进一步的细节将在下文中提供。然而,应该认识到,植入物10的其它构造也是可能的,以在植入物10和板12通过插入器械接合时,允许植入物10相对于板12的角度定向可以调整。例如,参照图4A,从替代实施例的植入物10a中已经省略了细长狭槽44和槽47、57。此外,插座46a大致构造成细长狭槽,该狭槽构造成接纳插入器械的倒圆特征,以便用器械固定住植入物10a,同时还在植入物10a和板12通过插入器械接合时,允许调整植入物10a相对于板12和插入器械的角度定向。作为另一实例,图4B示出另一替代实施例的植入物10b,从该植入物10b中已经省略了细长狭槽44和槽47、57。植入物10b包括呈正确形状的狭槽形式的插座46b,其构造成接纳插入器械的倒圆特征,以便用器械固定住植入物10b,同时还在植入物10b和板12通过插入器械接合时,允许调整植入物10b相对于板12和插入器械的角度定向。尽管在图4A和4B中未予示出,但应该认识到,与插座46a、46b相对定位的插座可与插座46a、46b类似地构造。此外,还应该认识到,除上述的差别之外,植入物10a、10b通常与植入物10类似地构造。
有关板12的进一步细节显示在图6-8中。板12包括沿着中心轴线68延伸的本体66,该中心轴线68定向成大致沿着脊柱SC的中心轴线延伸,并在板12植入时,从脊骨体V1延伸到脊骨体V2。在所示形式中,本体66一般地包括大致方形构造,但也可考虑其它的形式,在这些形式中,本体66沿着中心轴线68拔长并包括矩形的、卵形的或椭圆形的形状,这里只是提供几个实例而已。本体66包括上端或向头侧的端70以及相对的下端或尾部端72,以及延伸在端部70、72之间的相对的侧表面74、76。本体66还包括邻近上端70的上骨螺纹孔78、80,以及邻近下端72的下骨螺纹孔82、84。骨螺纹孔78、80和82、84延伸通过本体66的顶表面86和底表面88并在该两表面处敞开,大致地布置成允许骨螺钉斜向延伸通过和远离本体66。具体来说,骨螺纹孔78、80大致布置成允许骨螺钉延伸通过其中,以沿侧向、朝向头部的方向斜向延伸到板12,同时,骨螺纹孔82、84大致布置成允许骨螺钉延伸通过其中,以沿侧向、朝向尾部的方向斜向延伸到板12。尤其是,该结构中的骨螺纹孔78、80和82、84的定向允许使用相对较大的骨螺钉,导致更好地与邻近椎骨体接合和获益。此外,在该结构中,骨螺纹孔78、80和82、84的轨迹朝向板12上方的公共部位延伸,这样,使得通过板12插入螺钉所需的操作空间减小,由此,对病人周围解剖学结构的影响最小。在其它未示出的形式中,应该认识到,板12可设置有邻近于各个上端70和下端72的一个骨螺纹孔,或多于两个的骨螺纹孔。
本体66还包括可固定到带有螺纹轴的本体66上的固定元件86、夹子或允许固定构件86转动同时附连在本体66上的其它构造。固定元件86包括交叉形的构造,其包括端部86a-d和中心驱动工具插座88。为清楚起见,应该认识到,固定元件86已经从图7-8的本体66中省略了。固定元件86还包括凹陷弧形的侧壁部分90a-b,其可同时与相应邻近的骨螺纹孔78、80、82、84对齐,以使骨螺钉和其近端头部插入邻近的骨螺纹孔78、80、82、84内。当骨螺钉头部座落在骨螺纹孔78、80、82、84内时,固定元件86可转动,而使端部86a-d交迭相应的骨螺纹孔78、80、82、84,并阻塞或接触骨螺钉头部,以防止骨螺钉从骨螺纹孔78、80、82、84退出。还应该认识到,固定元件86的其它形状和设计也是可能的,用以防止骨螺钉从骨螺纹孔78、80、82、84退出。例如,在一个未予示出的形式中,固定元件86可呈螺纹紧固件的形式,在它附连到脊骨体V1、V2上之后,其与板12相接合,这样,螺纹紧固件的至少一部分的放大头部在骨螺纹孔78、80、82、84上延伸。
板12的本体66还包括延伸到侧表面74、76内的槽92、94,并从顶表面86延伸到底表面88。如图7所示,槽92包括插座96,其大致地具有跑道形状的构造。具体来说,插座96包括平行侧面,它们之间延伸着弓形的或倒圆的端部。如图8所示,槽94包括也大致地具有跑道形状构造的插座98。在其它未予示出的形式中,应该认识到,也可考虑提供几个可能性的包括卵形或多边形的其它构造。插座96、98构造成接纳插入器械的对应构造部分,其进一步的细节将在下文中提供。
此外,本体66还包括中间部分100,其包括面离顶表面86的凹陷形状的表面102。表面102大致构造成:当植入物10和板12彼此相邻地定位时,与植入物10的尾端22配合。中间部分100远离顶表面86延伸,以使表面102相对于底表面88的上部和下部104、106偏移顶表面86。类似地,例如,如图2所示,当底表面88的上部和下部104、106接触脊骨体V1、V2且板12与脊骨体V1、V2接合时,该结构导致表面102和至少一部分的中间部分100定位在脊骨体V1、V2之间的脊椎盘空间D内。然而,在其它未予示出的形式中,应该认识到,表面102可与底表面88的上部和下部104、106对齐,或相对于底表面88的上部和下部104、106朝向顶表面86偏移,这样,当板与脊骨体V1、V2接合时,板12没有延伸入脊椎盘空间D内的部分。在其它未予示出的形式中,表面102可以是平坦的,或包括凸出的形状,其构造成与具有凹陷尾端22的植入物10配合。
现在总地参照图9-17,将提供有关插入器械120的进一步细节,该插入器械构造成与植入物10和板12接合并相对于脊骨体V1、V2定位植入物10和板12。器械120沿着纵向轴线L从近端122延伸到远端124,并还包括内部构件126、外部构件128和驱动构件130。内部构件126延伸在螺纹的近端部分132和远端接合部分134之间。远端接合部分134分叉到部分148、150内,部分148、150包围中空内部160,尖齿136、138从其中延伸出。部分148、150还包括邻近于尖齿136、138近端的锥形表面162、164,部分148、150围绕通道158可枢转,使得尖齿136、138可相对于彼此移动,以便于器械120与植入物10和板12的接合和脱开接合。尽管未予示出,但应该认识到,弹簧和诸如橡胶塞那样的其它可回弹的弹性材料可定位在通道158内,使得尖齿136、138通常远离彼此地偏置。尖齿136包括远端的、大致为圆形的突出部140,其构造成定位在植入物10的插座46内。尖齿136还包括大致跑道形的突出部142,其近端地与突出部140间隔开,并构造成定位在板12的插座96内。尖齿136还构造成:当器械120与植入物10和板12接合时,尖齿定位在植入物10的槽47内和板12的槽92内。尖齿138包括远端的、大致为圆形的突出部144,其构造成定位在植入物10的插座56内。尖齿138还包括大致跑道形的突出部146,其近端地与突出部144间隔开,并构造成定位在板12的插座98内。尖齿138还构造成:当器械120与植入物10和板12接合时,尖齿定位在植入物10的槽57内和板12的槽94内。内部构件126还包括开口152,其斜向于纵向轴线L延伸到与中空内部160连通。另一组开口154、156与开口152相对地定位,并斜向于纵向轴线L延伸到与中空内部160连通。
外部构件128延伸在近端170和远端172之间,并包括接纳内部构件126的中空内部174。外部构件128还包括开口176,其斜向于纵向轴线L延伸到与中空内部174连通。突脊177沿着开口176的一部分延伸,并形成开口176的相对部分176a、176b。另一组开口178、180(图11)与开口176相对地定位,并斜向于纵向轴线L延伸到与中空内部174连通。当内部构件126定位在外部构件128内且器械120与植入物10和板12接合时,外部构件128的开口176大致与内部构件126的开口152对齐,而外部构件128的开口178、180大致与内部构件126的开口154、156对齐。类似地,在该结构中,开口152、176的配合允许骨螺钉通过器械120放置到板12的骨螺纹孔82、84内并通过板12的骨螺纹孔82、84。具体来说,开口176和开口152的部分176a布置成使得突脊177导向骨螺钉进入到板12的骨螺纹开口82内,同时,开口176和开口152的部分176b布置成使得突脊177导向骨螺钉进入到板12的骨螺纹开口84内。此外,开口154、156和开口178、180的配合,允许骨螺钉通过器械120放置到板12的骨螺纹孔78、80内并通过该骨螺纹孔78、80。具体来说,开口154和178大致相对于器械120布置,以导向骨螺钉进入板12的骨螺纹开口80,同时,开口156和180大致相对于器械120布置,以导向骨螺钉进入板12的骨螺纹开口78。此外,尽管前面未予讨论,但应该认识到,开口152、176的配合还可便于固定元件86插座88的接合,从而在放置骨螺钉之后便于固定元件86转动,但也可考虑通过中空内部160沿着器械120的长度插入器械来接合固定元件86。此外,尽管前面未予讨论,但也应该认识到,开口152、176、开口154、178和开口156、180的配合,也可便于用一个或多个诸如锥子、钻头或丝锥之类的器械进入到脊骨体V1、V2,这里只是提供几个可能性而已,以为骨螺钉准备脊骨体V1、V2。
外部构件128的近端170还包括环形槽182,槽182内定位固定环184,以使外部构件128与驱动构件130偶联,这样,驱动构件130独立地相对于外部构件128转动。驱动构件130包括内螺纹,内螺纹构造成与内部构件126的近端螺纹部分132接合。类似地,驱动构件130的转动导致内部构件126沿着纵向轴线L相对于外部构件128作轴向位移。销186从外部构件128延伸到内部构件126上的狭槽190内,以防止内部构件126相对于外部构件128转动。此外,锁定构件188延伸通过驱动构件130,并有选择地与内部构件126接合,一旦达到内部构件126和外部构件128之间要求的关系,便可阻止驱动构件130相对于内部构件126的转动。尽管前面未予讨论,但应该认识到,内部构件126沿着纵向轴线L相对于外部构件128沿近端方向的轴向运动,导致外部构件128的远端172与内部构件126的远端接合部分134的锥形表面162、164接合。当远端172与锥形表面162、164接合时,部分148、150和尖齿136、138被强制朝向彼此。此外,内部构件126沿着纵向轴线L相对于外部构件128沿远端方向的轴向运动,使外部构件128的远端172与锥形表面162、164脱开接合,从而允许部分148、150和尖齿136、138远离彼此移动。
如上所述,植入物10和板12不彼此偶联或其它方式彼此附连。然而,植入物10和板12可彼此相邻地定位,以使植入物10的尾端22与板12的表面102配合。当植入物10和板12定位在该结构中时,它们各可通过器械120接合,例如,如图18所示。具体来说,尖齿136可定位在板12的槽94内和植入物10的槽57内,令突出部140定位在植入物10的插座56内,突出部142定位在板12的插座98内。类似地,尖齿138可定位在板12的槽92内和植入物10的槽47内,令突出部144定位在植入物10的插座46内,突出部146定位在板12的插座96内。一旦尖齿136、138与植入物10和板12接合,内部构件126可相对于外部构件128近端地移动,以将植入物10和板12夹紧在尖齿136、138之间。植入物10和板12和器械120的接合一般以毗邻的关系固定住植入物10和板12。具体来说,突出部140、144与植入物10的插座46、56的接合,以及突出部142、146与板12的插座96、98的接合,可阻止植入物10离开板12位移。然而,一旦器械120脱开接合,植入物10便可离开板12位移。
尽管前面未予讨论,但应该认识到,插座46、56和突出部140、144的圆形构造,以及植入物10尾端22的凸出形状和板12表面102的对应的凹陷形状,在植入物通过器械120接合时,允许植入物10相对于器械120和板12转动。此外,槽96、98和突出部142、146的跑道形构造,阻止板12相对于器械120转动。在所示形式中,通过尖齿136与槽57的上表面58接触,以及尖齿138与槽47的上表面48接触,使得植入物10相对于板12和器械120的转动将在第一方向上受到限制,并通过尖齿136与槽57的下表面60接触,以及尖齿138与槽47的下表面50接触,使得植入物10相对于板12和器械120的转动将在第二方向上受到限制。类似地,应该认识到,上和下表面48、50相对于彼此的定向以及上和下表面58、60相对于彼此的定向可以修正,以在它们通过器械120接合时,便于区分出植入物10相对于板12的转动角度。然而,在其它形式中,可以考虑,植入物10可构造成其相对于板12的转动不受限制。
当通过器械120接合时,植入物10和板12可在单一外科手术步骤中一起相对于脊骨体V1、V2定位。具体来说,可将植入物10的前端20定位在椎骨V1、V2之间的脊椎盘空间D内,并将植入物推进到脊椎盘空间内,直到板12的底表面88接触脊骨体V1、V2。当插入植入物10和前进到脊椎盘空间D内时,植入物10可相对于板12转动,以有必要适应脊骨体V1、V2相对于脊椎盘空间D的定向。例如,当植入物10和板12用于脊柱SC的弧形或脊柱前凸部分内时,一旦植入物插入脊椎盘空间D内,植入物10可如图18所示斜向地延伸,而不是正交地延伸到板12。一旦植入物10合适地定位在脊椎盘空间D内,且板12对着脊骨体V1、V2定位,骨螺钉便可通过器械120插入,以用上面一对的螺钉和下面一对的螺钉附连到脊骨体V1、V2。在螺钉已经插入和被固定构件86覆盖之后,器械120便可与植入物10和板12脱开接合并从外科部位处移去。
图19-20中示出了替代实施例的插入器械200,其构造成与植入物10和板12接合,并相对于脊骨体V1、V2定位植入物10和板12。器械200沿着纵向轴线LL从近端202延伸到远端204,并包括内部构件206、外部构件208和驱动构件210。内部构件206延伸在螺纹的近端部分212和远端接合部分214之间。远端接合部分214分叉到部分216、218内,部分216、218形成尖齿220、222。部分216、218还包括靠近尖齿220、222定位的锥形表面,部分216、218相对于彼此侧向地位移,以使尖齿220、222可移动而便于器械200与植入物10和板12接合和脱开接合。尖齿220包括远端的、大致为圆形的突出部224,其构造成定位在植入物10的插座46内。尖齿220还包括大致跑道形的突出部226,其近端地与突出部224间隔开,并构造成定位在板12的插座96内。尖齿220还构造成:当器械200与植入物10和板12接合时,尖齿定位在植入物10的槽47内和板12的槽92内。尖齿222包括远端的、大致为圆形的突出部228,其构造成定位在植入物10的插座56内。尖齿222还包括大致跑道形的突出部230,其近端地与突出部228间隔开,并构造成定位在板12的插座98内。尖齿222还构造成:当器械200与植入物10和板12接合时,尖齿定位在植入物10的槽57内和板12的槽94内。
外部构件208延伸在近端232和远端234之间,并包括接纳内部构件206的中空内部。远端234还包括相对的尖齿236、238,它们构造成沿着尖齿220、222的侧向表面延伸并与侧向表面接合。外部构件208还包括锥形表面,它们靠近尖齿236、238定位并构造成与内部构件206的锥形表面接合。外部构件208的近端232还包括环形槽,其中定位有固定环240,以使外部构件208与驱动构件210偶联,这样,驱动构件210可相对于外部构件208独立地转动。驱动构件210包括内螺纹,其构造成与内部构件206的螺纹的近端部分212接合。类似地,驱动构件210的转动导致内部构件206沿着纵向轴线L相对于外部构件208作轴向位移。销242从外部构件208延伸到内部构件206上的狭槽内,以防止内部构件206相对于外部构件208转动。此外,锁定构件244延伸通过驱动构件210,并有选择地与内部构件206接合,一旦达到内部构件206和外部构件208之间要求的关系,便可阻止驱动构件210相对于内部构件206的转动。尽管前面未予讨论,但应该认识到,内部构件206沿着纵向轴线L相对于外部构件208沿近端方向的轴向运动,导致外部构件208的锥形表面与内部构件206的锥形表面接合,这迫使尖齿朝向彼此。此外,内部构件206沿着纵向轴线L相对于外部构件208沿远端方向的轴向运动,使内和外构件206、208的锥形表面脱开接合,从而允许部分216、218和尖齿220、222远离彼此移动。
当植入物10和板12如上所讨论地彼此邻近地定位时,它们可各通过器械200接合。具体来说,尖齿220可定位在板12的槽94内和植入物10的槽57内,令突出部224定位在植入物10的插座56内,突出部226定位在板12的插座98内。类似地,尖齿222可定位在板12的槽92内和植入物10的槽47内,令突出部228定位在植入物10的插座46内,突出部230定位在板12的插座96内。一旦尖齿220、222与植入物10和板12接合,内部构件206可相对于外部构件208近端地移动,以将植入物10和板12夹紧在尖齿220、222之间。植入物10和板12与器械120的接合一般以毗邻的关系固定住植入物10和板12。具体来说,突出部224、228与植入物10的插座46、56的接合,以及突出部226、230与板12的插座96、98的接合,可阻止植入物10离开板12位移。然而,一旦器械200脱开接合,植入物10便可离开板12自由地位移。
尽管前面未予讨论,但应该认识到,插座46、56和突出部224、228的圆形构造,以及植入物10尾端22的凸出形状和板12表面102的对应的凹陷形状,在植入物通过器械200接合时,允许植入物10相对于器械200和板12转动。此外,槽96、98和突出部226、230的跑道形构造,在器械与板12接合时,阻止板12相对于器械200转动。在所示形式中,通过尖齿220与槽57的上表面58接触,以及尖齿222与槽47的上表面48接触,使得植入物10相对于板12和器械200的转动将在第一方向上受到限制,并通过尖齿220与槽57的下表面60接触,以及尖齿222与槽47的下表面50接触,使得植入物10相对于板12和器械200的转动将在第二方向上受到限制。类似地,应该认识到,上和下表面48、50相对于彼此的定向以及上和下表面58、60相对于彼此的定向可以修正,以在它们通过器械200接合时,便于区分出植入物10相对于板12的转动角度。然而,在其它形式中,可以考虑,植入物10可构造成其相对于板12的转动不受限制。当通过器械200接合时,如上结合器械120所讨论的,植入物10和板12可在单一外科手术步骤中一起相对于脊骨体V1、V2定位。一旦植入物10和板12相对于脊骨体V1、V2定位,可将接纳骨螺钉而准备脊骨体V1、V2的一个或多个器械定位在尖齿220、222之间,并通过板12的骨螺纹孔78、80、82、84,其后通过板12从尖齿220、222之间插入骨螺钉。
如上所讨论的,器械120、200可用来接合和插入植入物10和板12,板12与植入物10是独立的;即,板12不是机械地附连或其它方式偶联到植入物10。在该形式中,植入物10和板12通过器械120、200以毗邻关系保持彼此邻近,但当不通过器械120、200接合时,可以其它方式相对于彼此自由地位移。此外,植入物10和板12与器械120、200的接合,允许植入物10相对于板12枢转,这通过器械120、200相对于器械120、200保持静止,这样,在植入物10和板12植入过程中,可调整植入物10相对于板12的定向。在其它未示出的形式中,应该认识到,植入物10和板12的构造可以反过来,使得板12可相对于植入物10枢转,这通过器械120、200相对于器械120、200保持静止,这样,在植入物10和板12植入过程中,可调整板12相对于植入物10的定向。在其它形式中,也可考虑使用器械120、200来接合和插入偶联到板的植入物。此外,尽管已经图示和描述了植入物10和板12的具体设计,但应该认识到,植入物10和板12其它的设计也落入本发明的范围之内。
此外,尽管前面未予讨论,但应该认识到,当植入物10和板12由器械120、200接合时,植入物10通常对中在板12上。类似地,在该结构中,板12通常相对于植入物10和对应的脊椎盘空间对中,在用器械120、200定位植入物10和板12之后,将植入物10插入脊椎盘空间内,无需对板12作任何进一步操纵或调整。尤其是,通过该结构使板12相对于植入物10对中,可导致骨螺纹孔78、80和82、84相对于定位在脊椎盘空间相对侧上的脊骨端板合适地定位,以便通过其中插入骨螺钉,并与脊骨接合。类似地,在某些方面,由于器械120、200提供了板12相对于植入物10的对中效应,假定骨螺纹孔78、80和82、84相对于邻近的脊骨合适地放置,板12便可设置有相对较短的长度。然而,在其它的方面,可以考虑板12的长度由于该结构而不作调整。
在一个实施例中,对第一和第二脊骨提供稳定的系统包括植入物和板,该植入物构造成定位在脊骨之间,而板构造成对着各个脊骨的外表面定位并与外表面接合。植入物和板可在一种结构中各由单一的外科器械接合,该结构在植入物和板植入过程中,便于调整植入物和板相对于彼此的定向。此外,通过器械使植入物和板接合,可在单一外科手术步骤中,便于一起植入该植入物和板,不去除植入物相对于板的可调整性。在一个方面,植入物和板相对于彼此独立(即,植入物和板彼此不偶联),当器械与板接合时,器械使植入物和板保持毗邻的关系。
尽管前面未予讨论,但应该认识到,除非另有描述,否则,文中所述的植入物、装置和器械可用任何合适的生物相容材料制造,包括但不限于:钛、钛合金、不锈钢、金属合金、多芳基醚酮(PAEK)、聚醚醚酮(PEEK)、碳加强的PEEK、聚醚酮酮(PEKK)、聚砜、聚醚酰亚胺、聚酰亚胺、超高分子量的聚乙烯(UHMWPE),以及塑料等,这里只举出几个可能性而已。植入物和板可用相同材料制造,或用不同材料制造。当然,可以理解的是,对于所要测量的特殊脊骨,以及对于植入物和板将要相对于其定位的脊骨的特殊部位或结构来说,各部件的相对尺寸可以修改。
此外,还应该认识到,文中所述的植入物、器械、装置、系统、技术和方法也可用于涉及动物的外科手术中,或用于培训、教育、市场行销、销售和/或广告目的的演示。此外,文中所述的植入物、器械、装置、系统、技术和方法也可用于诸如尸体那样非生命物体上或结合非生命物体使用,培训辅助或模型,或结合外科系统的试验、外科手术、整形外科器械和/或装置。
文中陈述的任何理论、操作机理、证据或发现都旨在进一步提高对本发明的理解,决不意图令本发明依赖于如此的理论、操作机理、证据或发现。应该理解到,以上描述中使用的词语“较佳的”、“较佳地”或“首选的”,表示如此描述的特征可能更加理想,然而,它可能不是必要的,缺乏这样特征的实施例可认为仍在本发明的范围之内,本发明范围由附后的权利要求书来定义。在阅读权利要求书时,当使用诸如冠词“a”、“an”、“至少一个”,和/或“至少一部分”等的词语/词组时,并无意图将权利要求书限制到仅一个物项,除非在权利要求书中具体地有相反之陈述。此外,当使用语言“至少一部分”和/或“一部分”时,该项可包括一部分和/或全部项,除非具体地有相反之陈述。
尽管在附图和以上的描述中已经详细地图示和描述了本发明,但这些附图和以上描述应被看作是说明性的而不是限制的特性,应该理解到,仅是选定的实施例已作了图示和描述,落入文中所定义或由任何以下的权利要求书定义的本发明精神之内的所有的变化、修改和等价物,都要求受到保护。

Claims (14)

1.一种用于提供脊椎稳定的系统,所述系统包括:
植入物,所述植入物包括从前端延伸到相对的尾端的本体,所述本体包括上骨接合表面和相对的下骨接合表面,当所述植入物定位在上和下椎骨之间的脊椎盘空间内时,所述上和下骨接合表面接合所述上和下椎骨相应的端板;
用于与所述上和下椎骨接合的板,所述板包括在上端与相对的下端之间延伸的板本体,所述板本体包括顶表面和相对的底表面,当所述板与所述上和下椎骨接合时,所述顶表面和底表面面对所述上和下椎骨,所述板包括多个孔和可转动地设置在所述板的外表面上的固定元件,所述固定元件包括由间隙所间隔的多个臂,以致于所述固定元件可在第一位置与第二位置之间转动,在所述第一位置中,所述臂不覆盖所述多个孔,在所述第二位置中,所述臂覆盖住所述多个孔;以及
插入器械,所述插入器械包括接合部分,该接合部分构造成可释放地与所述植入物和所述板相接合,其中,当所述植入物和所述板通过所述器械接合时,所述植入物相对于所述板的角度定向可调整。
2.如权利要求1所述的系统,其特征在于,当所述植入物和所述板通过所述插入器械接合时,所述板相对于所述器械的转动受到限制。
3.如权利要求2所述的系统,其特征在于,所述植入物和所述板与所述器械的接合阻止所述植入物相对于所述板位移,而一旦所述植入物和所述板脱开与所述器械接合,则所述植入物可相对于所述板自由地移位。
4.如权利要求1所述的系统,其特征在于,所述植入物包括第一对插座,所述第一对插座定位在所述上和下骨接合表面之间的所述植入物的相对侧上,所述板包括第二对插座,所述第二对插座定位在所述顶表面和底表面之间的所述板的相对侧上。
5.如权利要求4所述的系统,其特征在于,所述器械的所述接合部分包括一对相对定位的尖齿,所述尖齿各包括第一突出部和第二突出部,所述第一突出部构造成定位在所述第一对插座中的对应一个内,而第二突出部构造成定位在所述第二对插座中的对应一个内。
6.如权利要求5所述的系统,其特征在于,所述板包括第一和第二槽,它们形成在所述相对侧内并在所述顶表面和底表面之间延伸,所述第二对插座中的对应一个定位在各个所述第一和第二槽内。
7.如权利要求6所述的系统,其特征在于,所述植入物包括第一槽口和第二槽口,所述第一槽口从所述第一对插座中的第一个延伸且通过所述植入物的所述尾端开口,所述第二槽口则从所述第一对插座中的第二个延伸且通过所述植入物的所述尾端开口。
8.如权利要求7所述的系统,其特征在于,当所述植入物和所述板通过所述器械接合时,所述尖齿定位在所述第一槽口和所述第一槽以及所述第二槽口和所述第二槽的相应一个内。
9.如权利要求5所述的系统,其特征在于,所述尖齿的所述第一突出部包括大致圆柱形构造,所述尖齿的所述第二突出部包括大致跑道形构造。
10.如权利要求5所述的系统,其特征在于,所述尖齿的所述第一突出部定位在所述器械的远端,而所述尖齿的所述第二突出部在所述第一突出部的近端间隔开。
11.如权利要求1所述的系统,其特征在于,所述板本体包括第一对孔和第二对孔,所述第一对孔邻近于所述上端并延伸通过所述顶表面和底表面,所述第二对孔邻近于所述下端并延伸通过所述顶表面和底表面,所述板还包括第一对骨接合紧固件和第二对骨接合紧固件,所述第一对骨接合紧固件延伸通过所述第一对孔以与所述上椎骨接合,所述第二对骨接合紧固件延伸通过所述第二对孔以与所述下椎骨接合。
12.如权利要求1所述的系统,其特征在于,所述多个孔构造成便于一个或多个骨接合紧固件通过所述插入器械和所述板插入,以便与所述椎骨接合。
13.如权利要求1所述的系统,其特征在于,所述固定元件等距离地定位在所述板本体的上端与下端之间,并且等距离地定位在所述板本体的相对两侧之间。
14.一种用于提供脊椎稳定的系统,所述系统包括:
植入物,所述植入物包括从前端延伸到相对的尾端的本体,所述本体包括上骨接合表面和相对的下骨接合表面,当所述植入物定位在上和下椎骨之间的脊椎盘空间内时,所述上和下骨接合表面接合上和下椎骨相应的端板;
与上和下椎骨接合的板,所述板包括在上端和相对的下端之间延伸的本体,所述板本体包括近端表面、相对的远端表面以及面向远端的中间部分,所述中间部分构造成与所述植入物的所述尾端配合,所述板包括多个孔和可转动地设置在所述板的外表面上的固定元件,所述固定元件包括由间隙所间隔的多个臂,以致于所述固定元件可在第一位置与第二位置之间转动,在所述第一位置中,所述臂不覆盖所述多个孔,在所述第二位置中,所述臂覆盖住所述多个孔;以及
插入器械,所述插入器械包括接合部分,所述接合部分构造成可释放地与所述植入物和所述板相接合,其中,当所述植入物和所述板通过所述器械接合时,所述植入物和所述板保持邻近的关系,一旦脱开与所述器械接合,所述植入物便从所述板移位。
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