CN101389279B - 多轴线骨附连组合件 - Google Patents

多轴线骨附连组合件 Download PDF

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CN101389279B
CN101389279B CN200580024659XA CN200580024659A CN101389279B CN 101389279 B CN101389279 B CN 101389279B CN 200580024659X A CN200580024659X A CN 200580024659XA CN 200580024659 A CN200580024659 A CN 200580024659A CN 101389279 B CN101389279 B CN 101389279B
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molectron
saddle member
hole
anchoring element
packing ring
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CN101389279A (zh
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R·A·法利斯
H·S·泰勒
J·W·波伊内尔
B·J·科茨
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Warsaw Orthopedic Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A—HUMAN NECESSITIES
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    • 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
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    • 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7038—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other to a different extent in different directions, e.g. within one plane only
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    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
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    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
    • A61B2090/035—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself preventing further rotation

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Abstract

一种后路固定系统，该系统包括鞍形元件和锚定元件。锚定元件将鞍形元件固定于骨。鞍形元件包括可形成通道的一对竖直部分。鞍形元件还具有由内壁限定的通过其中的孔穴，孔穴在鞍形元件中形成下方开口。鞍形元件中的下方开口可包括围绕鞍形轴线对称排列的倾斜切口，以增加骨螺钉相对于鞍形元件的轴线的可成角度。通道适合接受矫形外科杆，鞍形元件中的孔穴适合接受锚定元件。鞍形元件和锚定元件可连接以实现元件的多轴线运动。

Description

多轴线骨附连组合件
技术领域
本发明一般涉及用于矫正脊椎损伤或变形的矫形外科植入物，更具体地、但非排他性地涉及用于固定一部分脊椎、如颈椎，从而将其矫正或使其复原的装置。
背景技术
在脊椎外科领域，已知出于多种原因将植入物置于椎骨中，包括(a)矫正脊柱异常弯曲，其中包括脊柱侧凸弯曲，(b)为断裂或受损椎骨维持适当间隔并提供支撑，和(c)在脊柱上进行其它治疗。
典型的植入物系统利用杆作为支撑和稳定元件。在这种植入物中，将两个或多个螺钉插入需进行植入的两个或多个椎骨中。然后，将杆植入或连接于螺钉头部，或者植入连接杆与螺钉头部的连接装置，并将连接固定。这样，一支撑结构固定于椎骨。
许多种骨固定螺钉的结构是单轴的。就是说，这种装置连接于杆或板，使得通过杆或板的纵轴线与通过固定装置的纵轴线相互间只能有一种定位。虽然在某些情况下是有用的，但在许多治疗情况下，使用这种不可弯曲装置所需的精密度是不切实际的。
近来，引入了具有多轴性能的骨固定装置。这种结构的例子参见美国专利5,797,911、5,954,725、5,810,818和6,485,491，它们被结合于此作为参考。这些装置有助于降低放置固定装置所需的精度，因为固定装置的鞍形部分是可沿多轴线放置在锚定部分上的。因此，可放置鞍形部分以便接受杆，限制或消除已有装置所固有的许多放置方面的困难。
大多数这种装置被设计成用于胸椎或腰椎高度的脊柱固定，且仅允许锚定元件相对于鞍形元件成有限的角度。本领域需要一种多轴线骨附连组合件，具体是具有更大成角程度的、可用于脊柱颈椎区域的组合件。
发明内容
本发明的一个实施方式是一种独特的多轴线骨附连组合件，其包括鞍形元件和骨锚定元件。鞍形元件具有多个竖直部分，这些竖直部分形成穿过鞍形元件的通道。鞍形元件还具有由内壁限定的、通过其中的孔穴，孔穴形成鞍形元件中的下方开口。鞍形元件中的下方开口可包含围绕鞍形元件的轴线对称排列的倾斜切口，以增加所允许的骨螺钉相对于鞍形元件的轴线可成的角度。切口的位置、角度和数量可根据多轴线骨附连组合件的应用需要而变化。骨锚定元件延伸通过开口。骨锚定元件包括头部和锚定部分。本发明的另一个实施方式包括垫圈(顶部元件)。垫圈可具有凹陷部分以容纳矫形杆，并可包括径向延伸的突出物。垫圈匹配入鞍形元件的孔穴，位于骨锚定元件上方。
参考附图，由示例性实施方式的描述，本发明各种实施方式的其它特征和实际优点将显而易见。
附图说明
图1显示了根据本发明一个实施方式的骨锚定组合件的局部横截面图。
图2显示了根据本发明另一个实施方式的骨锚定组合件的局部横截面图。
图3显示了根据本发明一个实施方式的鞍形元件的侧视图。
图4显示了根据本发明一个实施方式的鞍形元件的侧视图。
图5显示了根据本发明一个实施方式的鞍形元件的截面视图。
图6显示了根据本发明另一个实施方式的鞍形元件的截面视图。
图7显示了图2中的鞍形元件的俯视图。
图8显示了一个实施方式的锚定元件的侧视图。
图9显示了根据本发明一个实施方式的垫圈的立体图。
图10显示了图10中的垫圈的俯视图。
图11显示了图9中的垫圈的横截面图。
图12显示了根据本发明另一个实施方式的垫圈的俯视图。
图13显示了根据本发明一个实施方式的紧定螺钉的侧视图。
图14显示了图13紧定螺钉的俯视图。
图15显示了根据本发明另一个实施方式的外紧定螺钉的横截面图。
图16显示了图15外紧定螺钉的俯视图。
图17显示了本发明中所使用的卡环的立体图。
图17a显示了本发明中所使用的另一种实施方式的卡环的侧视图。
图18显示了图17中的卡环的俯视图。
图19显示了根据本发明另一个实施方式的骨锚定组合件的局部横截面图。
图20显示了一个实施方式的图19所示鞍形元件的横截面图。
图21显示了图20中的鞍形元件的俯视图。
图22显示了图19所示垫圈的横截面图。
图23显示了根据本发明一个实施方式的鞍形元件的仰视图。
图24显示了图23鞍形元件的等轴测图。
图25显示了根据本发明一个实施方式的鞍形元件的仰视图。
图26显示了图25鞍形元件的等轴测图。
图27显示了根据本发明一个实施方式的鞍形元件的横截面图。
具体实施方式
现在将参考附图所示实施方式并采用具体语言描述这些实施方式。但是，应理解这些实施方式并不限制本发明的范围，认为所示装置中的改变或进一步改进，以及本文所示本发明实施方式原理的进一步应用都是本发明所属领域技术人员通常所明白的。
在图1中显示了多轴线骨锚定组合件20的一个实施方式。骨锚定组合件20包括鞍形元件22、骨锚定元件24和紧定螺钉元件30。鞍形元件22通常为U形，它的两个竖直部分32形成延伸通过鞍形元件22的通道34。然后，通道34被构造成可容纳细长元件36，例如脊柱杆。为实现后路颈部固定，杆36可具有多种所需长度和直径中的一种。如图1所示，通道34的宽度稍大于杆36的直径，这使杆36更容易插入通道34，也可补偿杆的外形修整，并且使同一鞍形元件22可采用一定范围内的杆尺寸。如图3所示，设置通道34的弯曲底部255，使得当完全嵌套入孔穴38的下部时，骨锚定元件24头部58的顶部可在通道34的弯曲底部255的边缘上延伸，使得位于通道34中的杆36紧密啮合骨锚定元件24的头部58。鞍形元件22还包括穿过其中的孔穴38，孔穴38的轴线基本上垂直于通道34的轴线。
在图1、2和19所示的鞍形元件22的具体实施方式中，竖直部分32各自具有外表面40和内表面42。内表面42基本上平行于孔穴38的轴线，且沿鞍形元件22的纵轴线。在图3所示实施方式中，(**)外表面40相对于内表面42和鞍形元件22的纵轴线倾斜而向内呈锥形，这种锥形使鞍形元件22的操纵更容易并减小鞍形元件22的体积。在鞍形元件22的底部附近，孔穴38由壁部分44所限定。在一个实施方式中，壁部分44包括圆形区段52，其平面基本上垂直于孔穴38的纵轴线。但是，壁部分44和区段52可以是任何形状，只要孔穴38在壁部分44的区段52处的直径大于骨锚定元件24的柄部72的直径且小于骨锚定元件24的头部58的直径。
竖直部分32还包括内螺纹部分52，如图1所示。内螺纹部分52被构造成螺纹连接紧定螺钉30，如下所述。在其它实施方式中，如图2和19所示，分别构建内螺纹部分52a和52d，使得当紧定螺钉30固定在鞍形元件22中时，内螺纹部分终止于杆36上方。在一个实施方式中，如图2和19所示，鞍形元件22包括延伸围绕孔穴38的释放槽(relief groove)16。释放槽16消除了内螺纹上通常发现的螺旋状螺纹跳动。在另一些实施方式中，鞍形元件22不包括释放槽。在又一些实施方式中，如图4所示，竖直部分32可包括外螺纹部分64而不是内螺纹部分。外螺纹部分164被构造成螺纹连接外紧定螺钉30a，如下所述。在该实施方式中，外表面40相互平行。
在壁部分44下方，孔穴38通过圆锥形壁部分46向外开放。通过减少鞍形元件22下部对骨锚定元件24的柄部部72的干扰，圆锥形壁部分46使骨锚定元件24能以任何无限数量的有限角度相对于鞍形元件22的纵轴线定位。
如图23-27所示，壁部分44的圆锥形壁部分46包含围绕孔穴38的纵轴线对称排列的倾斜切口62以增加骨螺钉相对于孔穴38的纵轴线的可成角度。任何切口数量、切口形状、切口相对于通道34轴线的位置、切口相对于垂直于孔穴38轴线的平面的角度、切口尺寸以及各切口间的角度间隔可对于特定应用而变化。如图23和24所示，存在三个大致为圆柱形的倾斜切口。两个倾斜切口62从通道34的轴线偏移30度，所有三个倾斜切口62相互间隔120度。如图25和26的实施方式所示，存在三个大致为圆柱形的倾斜切口。其中一个倾斜切口62在通道34的轴线上，所有三个倾斜切口62相互间隔120度。
如图8所示，本发明一个实施方式的骨锚定元件24包括含螺纹60的螺纹部分56、柄部72和头部58。在一个实施方式中，骨锚定元件24的头部58基本上为球形。但是，应理解，也可采用离开头部58的中心等距离的任何外形。在所示实施方式中，头部58的上部形成有工具啮合凹槽76。可选择工具啮合凹槽76的特定形状以配合任何合适的螺钉驱动工具。相互之间，螺纹部分56的直径应小于头部58的直径，柄部72应比螺纹部分56的最宽部分要窄。显然，可采用适合插入椎骨体的任何头部设计、柄部设计、螺距或尖端锥形。如果螺距允许旋入壁部分44，螺纹部分56甚至可以比头部58更大。
多轴线骨锚定组合件20可还包括紧定螺钉30。在该实施方式中，如图13-14所示，紧定螺钉30大致为圆柱形，具有外螺纹102。在一个实施方式中，外螺纹102是锯齿螺纹。在另一个实施方式中，螺纹102是倒角螺纹，以尽可能减小两竖直元件32间的端间隙。这种倒角螺纹的一个例子在美国专利6,296,642中描述，该专利被结合于此作为参考。
如图13-14所示，该实施方式的紧定螺钉30包括基本上为平面的端面110，以尽可能减小组合件20的剖面。紧定螺钉30还包括工具啮合镗孔112。工具啮合镗孔112与工具联用，用于将紧定螺钉30引入鞍形元件22。
在另一个实施方式中，如图15-16所示，紧定螺钉30a包括内螺纹202，以匹配鞍形元件22的竖直延伸元件32上的外螺纹164。紧定螺钉还包括内螺塞部分300，它具有底面以抵靠位于鞍形22中的杆36的顶面，在一个实施方式中提供一种向下驱动杆36以抵靠骨锚定元件24的头部的手段，在另一个实施方式中提供一种向下驱动杆36以抵靠垫圈26的手段。在另一个实施方式中，内螺塞300的底面301包括许多隆起的金属突出物，以啮合并压入杆36。紧定螺钉30a的一端具有工具啮合镗孔112。如图15所示，紧定螺钉30a还可包括圆形端面206以减少对患者的内在创伤，或为大致平面的端面以尽可能减小组合件20的剖面。工具啮合镗孔112与工具联用以将紧定螺钉30a引入鞍形元件22。
在图2中，显示了本发明另一个实施方式的多轴线骨锚定组合件20a。类似于图1所示以及以上所述实施方式，骨锚定组合件20a包括骨锚定元件24和紧定螺钉元件30。但是，该实施方式还包括垫圈(顶部元件)26。还是在本实施方式中，构建内螺纹部分52a，使得当紧定螺钉30固定在鞍形元件22中时，内螺纹部分52a终止于杆36上方。鞍形元件22还包括围绕孔穴38延伸的释放槽16。在一些实施方式中，组合件20a还包括C形卡环28，该卡环如以下所述那样匹配鞍形元件22。
在图2、5和7所示实施方式中，鞍形元件22还包括围绕孔穴38延伸的内部凹槽48。凹槽48被构造成容纳压缩状态下的卡环28，即凹槽48的外径至少稍小于卡环28的正常未压缩时的外径。所示实施方式的鞍形组合件22还包括一个或多个在各个竖直部分32中纵向延伸的沟槽50。如下进一步所述，一个或多个沟槽50适于放置垫圈26，并可以是圆形(例如圆柱形)、方形、或其它合适的形状以容纳垫圈26。在该实施方式中，设置通道34的弯曲底部255，使得当杆36插入其中时，杆36将压制啮合垫圈，垫圈26本身将压制啮合骨锚定元件24的头部58。
现在参考图9-12，其中显示了本发明一个实施方式的垫圈26。垫圈26包括上部80、下部82以及通过其中的孔穴84。上部80和下部82可构建为整体或独立构建并通过任何已知的方式连接在一起。在所示实施方式中，上部80的上表面86可包括凹陷部分88，凹陷部分88形成大小和构型可容纳细长元件(例如，图1的杆36)放置在其中的圆柱体的一部分。下部82还包括面向卡环28的上表面83。
现在参考图11，垫圈26具有穿过上部80和下部82设置的孔穴84。孔穴84包括下凹面96和柱面98。在一个具体的实施方式中，凹面96为球形以与锚定元件24头部58的一部分基本一致。下部82通常为圆盘形，并可包括一个或多个从其沿径向延伸的突出物90。突出物90与沟槽50配合，使垫圈26的凹陷部分88与通道34a对齐并防止垫圈26旋转，以尽可能减少杆36与凹陷部分88之间的错位。
在一个实施方式中，如图9-10所示，突出物90各自包括两个基本上为平面的侧表面92，以及圆形且可形成圆柱体的一部分的端面94。调节突出物90的大小和形状，以匹配和容易滑入鞍形元件22竖直部分32a的沟槽50中。在图12所示的另一个实施方式中，突出物90a各自包括圆形端面100。
在一些实施方式中，多轴线骨锚定组合件20a包括卡环28以使垫圈26抵靠锚定元件24固定。这种卡环28的一个实施方式如图17-18所示。卡环28具有中央开口114和形成于其中的压缩狭缝116。卡环28还具有第一表面118、相对的第二表面120、限定开口114的内侧表面122以及外侧表面124。压缩狭缝116允许卡环28压缩并匹配入鞍形元件22的内部凹槽48。凹槽48入口的直径至少稍小于未压缩卡环28的外径126。卡环28的开口114的内径能使卡环28匹配在垫圈26的上部80周围。表面118和120中的一个与下部82的上表面83啮合，以固定垫圈26。卡环28可具有方形截面，如图2所示，或者是圆形或其它合适形状的截面，在一个特定的实施方式中由形状记忆合金如镍钛合金(nitinol)构成。
另一个实施方式的卡环28’如图17a所示。卡环28’为非平面，且在一个实施方式中具有其中形成有相对峰129a和相对谷129b的一系列波状起伏。或者，非平面卡环28’可具有其它弯曲构型，或者可具有沿其延伸的指形弹簧元件。一旦组装组合件20a，非平面卡环28’使鞍形元件22、锚定元件24和垫圈26间的间隙更小，因为非平面卡环28’可填充更大部分的鞍形元件22的凹槽。
在图19中，显示了工具本发明另一个实施方式的多轴线骨锚定组合件20d。类似于上述图1所示以及以上所述实施方式，骨锚定组合件20d包括骨锚定元件24和紧定螺钉元件30。然而，该实施方式还包括垫圈(顶部元件)26d。在一些实施方式中，组合件20d还包括C形卡环28，该卡环如以下所述那样匹配鞍形元件22d。
鞍形元件22d具体显示的实施方式可包括内部凹槽48d。如图所示，凹槽48d围绕孔穴38d延伸，在该具体实施方式中，凹槽48d在凹槽48d的顶部与其底部之间是一致的。凹槽48d被构造成可容纳压缩状态下的卡环28。在一种形式中，凹槽48d的厚度264大于卡环28。并且，图20-21所示鞍形物组合件22d的实施方式不包括在各竖直部分32d内纵向延伸的沟槽50。竖直部分32d还包括内螺纹部分52d，其被构造成螺纹连接紧定螺钉30。
现在参考图22，显示了本发明另一个实施方式的垫圈26d。垫圈26d包括上部80d、下部82d、卡环凹槽266以及穿过其中的孔穴84d。上部80d、下部82d、卡环凹槽266可一体构建或独立构建并以任何已知的方式连接在一起。卡环28匹配在凹槽266内，以使垫圈26d固定在鞍形元件22d内。在一个实施方式中，通过将锚定元件24a插入并穿过鞍形元件22d中的孔穴38d来组装组合件20d。然后，当卡环28位于至少一部分凹槽266中，将垫圈26d插入孔穴38d。随着垫圈26d穿过鞍形元件22d，卡环28压入凹槽266，并膨胀入沟槽48d以使垫圈26d保持在鞍形元件22d内。然后，将细长元件插入通道34d，将紧定螺钉(如以上所述的那种)旋入鞍形元件22d的内螺纹部分52d，以将细长元件、垫圈26d和锚定元件24a锁定在一起。
垫圈26d具有穿过上部80d和下部82d设置的孔穴84d。孔穴84d包括下凹面96d和柱面98d。下凹面96d适合容纳锚定元件24a的头部58a。在图22所示具体实施方式中，下部82d通常为圆盘形状。在该具体实施方式中，下部82d不具有突出物90。
虽然在附图和上述说明中详细显示和描述了本发明的实施方式，认为这些实施方式是示例性而不是限制性的。应理解，仅显示和描述了优选的实施方式。

Claims (14)

1.一种多轴线骨附连组合件，所述组合件包括：
骨锚定元件，它包括头部和锚定部分；
鞍形元件，它具有多个竖直部分，这些竖直部分形成通过所述鞍形元件的通道以使长形杆可接纳在其中，其中，所述竖直部分包括螺纹部分，所述鞍形元件还具有由内壁限定的穿过其中的孔穴，所述骨锚定元件可插入并穿过该孔穴，所述孔穴在所述鞍形元件中形成下方开口，该下方开口啮合所述骨锚定元件的头部，从而防止所述骨锚定元件的头部穿过其中，其中，所述下方开口包含围绕鞍形元件的纵轴线对称排列的许多倾斜切口；以及
用于螺纹啮合所述多个竖直部分的螺纹部分的紧定螺钉，所述紧定螺钉还包括用于啮合所述长形杆的啮合部分；
还包括用于容纳所述长形杆的垫圈，所述垫圈匹配入所述鞍形元件的所述孔穴中且位于所述骨锚定元件上方，所述垫圈包括用于容纳所述长形杆的凹陷部分，所述竖直部分各自具有一个或多个形成在其中的沟槽，所述垫圈包括一个或多个对齐元件与其匹配，以尽可能减少所述杆与所述凹陷部分之间的错位。
2.如权利要求1所述的组合件，其特征在于，所述竖直部分为内螺纹，所述紧定螺钉为外螺纹。
3.如权利要求2所述的组合件，其特征在于，所述螺纹部分具有倒角螺纹。
4.如权利要求1所述的组合件，其特征在于，所述竖直部分为外螺纹，所述紧定螺钉为内螺纹。
5.如权利要求4所述的组合件，其特征在于，所述紧定螺钉包括凸圆形上表面。
6.如权利要求4所述的组合件，其特征在于，所述螺纹部分具有倒角螺纹。
7.如权利要求1所述的组合件，其特征在于，所述锚定元件是骨螺钉。
8.如权利要求7所述的组合件，其特征在于，所述骨螺钉包括具有凸形下侧的头部。
9.如权利要求8所述的组合件，其特征在于，所述凸形下侧是球形。
10.如权利要求1所述的组合件，其特征在于，当所述紧定螺钉完全螺纹啮合入所述多个竖直部分中时，所述螺纹部分位于所述长形杆上方。
11.如权利要求10所述的组合件，其特征在于，所述内壁包括邻近所述螺纹部分的释放槽。
12.如权利要求1所述的组合件，其特征在于，所述内壁包括凹槽，所述组合件还包括匹配在所述凹槽内的卡环以使所述垫圈保持在所述鞍形元件的所述孔穴中。
13.如权利要求1-12中任一项所述的组合件，其特征在于，所述下方开口为圆形开口。
14.如权利要求13所述的组合件，其特征在于，所述圆形开口为平面且基本上垂直于所述鞍形元件的纵轴线。
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