CN100462058C - 可变偏置式脊柱固定系统 - Google Patents

可变偏置式脊柱固定系统 Download PDF

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CN100462058C
CN100462058C CNB2004800162091A CN200480016209A CN100462058C CN 100462058 C CN100462058 C CN 100462058C CN B2004800162091 A CNB2004800162091 A CN B2004800162091A CN 200480016209 A CN200480016209 A CN 200480016209A CN 100462058 C CN100462058 C CN 100462058C
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body element
orthopedic instruments
compressible ring
hole
ring
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CN1832705A (zh
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M·M·莫里森
D·N·贝克
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Warsaw Orthopedic Inc
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    • 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
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • 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
    • A61B17/68—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
    • A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped
    • 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
    • A61B17/68—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
    • A61B17/7041—Screws or hooks combined with longitudinal elements which do not contact vertebrae with single longitudinal rod offset laterally from single row of screws or hooks
    • 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
    • A61B17/68—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
    • A61B17/704—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other the longitudinal element passing through a ball-joint in the screw head

Abstract

一种用于将纵向零件如脊柱杆锁定于骨固定件的骨固定系统，使纵向零件的轴线相对于骨固定的轴线可变取向。被狭槽沿基本水平面分裂成上部和下部的一件式主体零件包括纵向零件如脊柱杆可通过其中的球状零件。骨固定件的一部分通过在主体零件的上部和下部的每一个上具有诸部分的孔。拧紧固定螺钉将主体零件的上部和下部拉在一起并将骨固定件和脊柱杆锁定在所需位置。

Description

可变偏置式脊柱固定系统
发明领域
本发明总地涉及医学植入物，尤其涉及适合于将纵向零件如杆连接于骨固定件的接受和锁定组件。
发明背景
已知许多用于治疗各种骨损伤、变形和疾病的医学植入物。在这些医学植入物中，有在外科手术过程中植入的脊柱固定系统以治疗多种问题。这些治疗包括矫正先天性脊柱畸形、修复脊柱损伤和融合椎骨，以稳定退变疾病并缓解慢性低腰背疼痛。已开发了几种技术和系统用于矫正和/或稳定脊柱和/或促进脊柱融合。在一种系统中，将一纵向零件如可弯曲杆沿脊柱的一部分放置，并通过许多固定零件将其沿脊柱纵向固定于两个或多个椎骨。这种脊椎固定零件可包括钩、各种类型的螺钉或螺栓，每个零件被构造成可接合椎体的特定部分。在一个实施例中，外科医生可在合适的解剖位置先将脊椎固定零件连接于脊柱，然后将每个脊椎固定零件连接于脊柱杆。一些固定零件包括适合于接受杆或其它纵向零件的头部。在其它系统中，接受和固定组件用于牢固地将杆连接于固定零件。
美国专利5,176,680公开了一种用于将脊柱杆固定于脊椎螺钉的装置。该脊柱杆通过一开口环，该开口环位于具有叉形头的脊椎螺钉的诸分叉之间。通过在诸分叉之间拧入的锁定螺钉将该组件锁入所需位置并直接锁定在开口环上。
用于将脊柱杆固定于骨螺栓的组件见美国专利5,938,663。该脊柱杆通过一位于锁定组件的钳夹内的开口环。螺栓的带螺纹头部通过锁定组件中的一对开口，并且锁紧螺帽拧在螺栓上。若拧紧锁定螺帽，锁定组件在一具体位置夹在锁紧螺帽和螺栓中间凸缘或螺栓头之间。
发明概述
本发明体现在下面的权利要求书中，以下的叙述不是以任何方式限制、限定或其它方式确定合法保护的范围。在一般意义上，本发明涉及用于将纵向零件锁定于骨固定(anchor)件的矫形器械。本发明的一个实施例涉及一矫形器械，该矫形器械包括具有固定(anchor)部分和杆部分的骨固定件，具有主体件和可压缩环的锁定组件以及和固定螺钉。主体零件包括由连接部分连接并由槽分开的下部和上部。下部和上部各包括第一孔和第二孔。第一孔的形状能使骨固定件的杆部分通过该孔。第二孔的形状能使固定螺钉(set screw)通过其拧上以压缩主体零件。主体零件还包括连接部分、上部和下部内的空腔。可压缩环包括用于接受纵向零件的中央通道，且位于主体零件空腔内。通过固定螺钉压缩主体零件可将压缩环和纵向零件锁定于所需位置。
附图简要说明
图1是本发明器械的一个实施例的立体图。
图1A是沿图1中的线13-13，在箭头方向观察的局部剖面图。
图2是如图1所示实施例的分解的立体图。
图3也是如图1所示实施例的立体图。
图4是如图1所示的主体零件的实施例的立体图。
图5是如图4所示实施例的俯视图。
图6是沿图5中的线6-6，在箭头方向观察的剖面图。
图7是沿图4中的线7-7，在箭头方向观察的剖面图。
图8是如图1所示的可压缩环的实施例的立体图。
图9是如图8所示实施例的端面图。
图10是沿图9中的线10-10，在箭头方向观察的剖面图。
图11是本发明器械另一个实施例的立体图。
图12是本发明器械再一个实施例一部分的立体图。
具体实施方式
为了促进对本发明原理的理解，现将叙述附图中所示的实施例和用专门语言来说明实施例。然而会理解到并不因此限制本发明的范围，为对于本发明相关领域的技术人员通常会发生的那样考虑了为本文所示本发明装置中的许多改变和修改，以及原理的进一步应用。
首先总地参考图1-3，显示根据本发明一个实施例的矫形器械20。矫形器械20包括蒂螺钉22、脊柱杆24以及包括主体零件28和可压缩环30的锁定组件26。蒂螺钉22基本上沿第一轴线连接于主体零件28，杆24在主体零件28内配合在环30内，使得杆24沿许多第二轴线的任一方向延伸，如下进一步所述。提供固定螺钉32用于压紧锁定组件26，也如下所述。
蒂螺钉22包括适合于插入椎体(未示出)的螺纹部分34和杆部分36。在所示实施例中，杆部分36沿其总的长度基本上是圆柱形(即基本上直径不变)，且较光滑，没有凸起、隆起或其它障碍物。会理解到杆部分36可具有除了圆柱形杆之外的截面，例如正六角形或相似的截面，或粗糙的表面。而且，可使用其它固定部分如钩代替螺纹部分34，或与螺纹实施例如蒂螺钉32一起使用钩零件。虽然在这里主要使用术语“蒂螺钉”，优选零件32可以是加工有螺纹、钩、或其它方式构造以啮合骨，以及可被构造成用于连接其它骨或骨部分。所示实施例的蒂螺钉22还包括适于啮合驱动工具的上部38以便于蒂螺钉22插入脊椎或其它骨中。在一个具体的实施例中，上部38包括内六角形座40。
现总地参考图4-7，显示锁定组件26的主体零件28的一个实施例。在本实施例中，主体零件28是沿基本水平面裂开的一件式零件。主体零件28具有带上表面44的上部42和下部46。部分42和46通过连接部分48连接并通过中间狭槽50分开。主体零件28还包括第一边47和第二边49。
第一孔52和第二孔54延伸通过主体零件28和狭槽50。在一个具体的实施例中，孔52和54具有基本上平行的轴线。孔52的上部56在主体零件28的上部42内且孔52的下部58在主体零件28的下部46内。孔54的上部60在主体零件28的上部42内且孔54的下部62在主体零件28的下部46内。上孔部分56与下孔部分58(图7)同轴线且上孔部分60与下孔部分62同轴线。
各孔部分56、58、60和62都包括上边、下边和内表面。因此，相对于孔52，上孔部分56具有上边64、下边66和内表面68，下孔部分58具有上边70、下边72和内表面74。在一个实施例中内表面68和74光滑且直径基本不变，或者可粗糙如通过压花产生或其它表面类型或处理。
相似地，相对于孔54，上孔部分60具有上边76、下边78和内表面80，下孔部分62具有上边82、下边84和内表面86。在一个实施例中内表面80光滑且直径基本不变。上孔部分60也可包括斜面或弄圆部分88。若固定螺钉32是压缩主体零件28的零件(如下所述)，内表面86带螺纹。
主体零件28还包括内空腔90。空腔90朝向主体零件28的边47和49敞开，形成一对同轴线开口92和94(图7)。开口92具有外边93且开口94具有外边95。在一个具体的实施例中，开口92和94的轴线基本上垂直于孔52的轴线(即上孔部分56和下孔部分58)和/或孔54的轴线(即上孔部分60和下孔部分62)。开口92和94的直径可基本不变，且大于杆24。或者，可对开口92和94的外边93和95倒角，以使杆24通过其的角度位置增加，如下进一步所述。
尤其参考图7，在一个实施例中空腔90优选包括中央部分98，它至少一部分由弧形(即凹形)壁部分100定界，并且，每侧还包括基本圆柱形的侧部102和104。侧部102包括壁103且侧部104包括壁105。在该具体实施例中，侧部102和104的半径比中央部分98的半径小且所有三部分同轴线。在中央部分98和各圆柱形侧部102和104之间是边缘表面106和108。
图8-10显示了一个可压缩环30的实施例。环30包括基本位于中央的通道112，形成同轴线开口111和113，和纵向狭槽114。优选地，环30包括邻近狭槽114的第一凸起116和第二凸起118。或者，环30可包括邻近狭槽114的单一凸起。中央通道112的尺寸能使杆24通过其中，并且，当环30处于非压缩状态时，杆相对于环30可平移和旋转移动。狭槽114允许压缩环30，以将杆24锁定在环30中，如下进一步所述。任选地，环30可包括与狭槽114相对的表面凹槽120，如图9所示，以使环30更加可弯曲并改善环30的压缩。选择环30的未压缩外径122以使其小于未压缩空腔90的内径，但大于处于压缩状态中的主体零件28的空腔90的内径91。环30和空腔90的未压缩直径间的关系使得在压缩前环30相对于空腔90可旋转地定向。具体地说，在矫形器械20植入过程中环30位于空腔90内时，直接或间接地通过操纵杆24通过环30的中央通道112，操纵环30，如下进一步所述。
如图10的实施例所示，中央通道112包括至少一个弧形(即凹形)内壁部分126的中央部分124，且每侧具有基本圆柱形侧向部分128和130。侧部128包括壁129且侧部130包括壁131。在该具体实施例中，侧部128和130的半径比中央部分124的半径小，且所有三部分同轴线。中央部分124及各侧部128和130之间是边缘表面132和133。
杆24优选是实质光滑(如喷丸处理)基本圆柱形的零件，具有足够的直径和强度以抵抗脊椎的负荷和压力。会理解到在其它实施例中杆24可带螺纹或具有正六角形或其它多角形截面。优选外科医生可弯曲或构造杆24，使其适于外科医生所需脊椎的治疗或支持。
固定螺钉32包括螺钉头136，适于啮合驱动工具，如带有内六角形座138，以及带螺纹的杆部分140。优选地，螺钉头136还包括斜面或弄圆部分142，以容纳主体零件28的上孔60的倒角或弄圆部分88。或者，固定螺钉32还可包括可分离头部结构特征。具有分离部分的固定螺钉的例子见美国专利6,193,719和6,478,795，其全部内容通过引用包括在此。图11显示矫形器械20的另一个实施例，它包括具有可分离头部分148的固定螺钉146。
现结合使杆24通过蒂螺钉22和锁定组件26连接于脊椎的(未示出)的一部分将描述矫形器械20及其各种零件的使用。本领域技术人员将明白，在本发明范围和精神内，可使用可替换的结构和方法，可装备主体的可替换的诸部分。
准备邻近需要治疗脊柱区域的外科手术部位，形成最小侵入性开口或其它切口，以接近脊柱。将蒂螺钉22通过切口插入椎骨至所需深度。在一个实施例中，插入蒂螺钉22，使其螺纹部分34的全部长度都位于骨内。将主体零件28置于螺钉22上，使蒂螺钉22的杆部分36插入通过主体零件28的孔52(即下孔部分58和上孔部分56)，如图1A所示。为了清楚表示，该图中除去了杆24和环30。优选地，在主体零件28插入外科手术部位并置于蒂螺钉22上之前，环30位于主体零件28的空腔90内。或者，在将主体零件28置于蒂螺钉22上之后，可将环30插入空腔90中。
在该具体实施例中，杆部分36没有凸起、隆起或其它障碍物，以使主体零件28沿杆部分36放置于任何所需的位置。优选地，主体零件28沿杆36放置，以使主体零件28不接触脊椎组织而不损伤该组织。一旦主体零件28位于蒂螺钉22上，将杆24插入主体零件28和环30，使杆24延伸通过中央通道112。外科医生操纵杆24和环30直到杆24相对于蒂螺钉22呈所需角度。这种可操纵性使杆24的最近点和蒂螺钉22之间的距离可变化，并且杆24相对于主体零件28和蒂螺钉22的角度可变化。或者，在通过主体零件28的孔52(即上孔部分56和下孔部分58)插入蒂螺钉22之前，可通过环30的中央通道112和主体零件28的空腔90插入杆24。
如果存在，图6中所示的环30上的凸起116和118，例如通过限制环30绕中央通道112的纵向轴线的旋转，使狭槽114与狭槽50基本保持对齐。已发现，所述对齐比狭槽114和狭槽50不对齐能允许更完全或有效压缩环30。如图3所示，通过空腔90内的环30的杆24在各个方向相对于空腔90的轴线的角度可大到至少20°。这种成角度使外科医生可按需调节杆24相对于蒂螺钉22的位置。
一旦按需组装并定位，矫形器械20锁定入适当位置中。如图6所示，将固定螺钉32通过上孔部分60插入孔54并拧入下孔62。拧紧固定螺钉32使主体零件28的上部42和下部46相互靠近以压缩主体零件28。
若通过拧紧固定螺钉32压缩主体零件28，上孔56的边64和66及下孔58的边70和72沿主体零件28的上部42和下部46枢转。迫使边66和68接触或撞击在杆部分36上，将主体零件28锁定于蒂螺钉22的杆36。如果主体零件28(即上部42和下部46受压后在一起)被压缩，空腔90也被压缩。空腔90的壁100、101和103压缩环110，并且，边106和108固定锁定环70防止旋转和平移。如果环110被压缩，中央通道112也被压缩。环110的壁125、126和127被压靠于抗杆24而保持杆24，并且，边132和133锁定杆24相对于蒂螺钉22的取向。
优选地，一旦将矫形器械20的组件锁定入所需取向，固定螺钉32的头部136与在主体零件28的上表面44平齐或在其之下，如图1所示。如上所述，器械20可包括具有可分离头部分148的固定螺钉146(图11)。优选地，一旦可分离头部分148从固定螺钉146除去，固定螺钉148的余下部分150与主体零件144的上表面44平齐或在其之下。
主体零件28’的另一个实施例如图12所示。除了孔52(容纳蒂螺钉22)离开空腔90的轴线更远之外，主体零件28’与主体零件28基本相同，如上所述。注意在图12中，连接孔52和54的轴线的线L1与垂直于空腔90的轴线的线L2形成钝角。这种改变可增加蒂螺钉22和杆24间的距离，用于较大的患者或涉及器械20的诸部分之间的附加空间和/或不同角度的情况。
装置的组件由用于外科植入的生物相容性材料构成，如不锈钢、各种钛合金、合适的硬塑料或其它已知材料。
虽然本发明在附图和前述中被详细图示和描述，但同样被认为是图示解释性和在性质上不是限制性的。应理解，只显示并描述了优选的实施例，且在本发明的精神范围内的所有变化和修改都要求保护。例如，在外科手术部位主体零件28置于蒂螺钉22上之前，杆24可连接于环30和主体零件28。在这种情况下，一个或多个主体零件28，每个具有插入其中的环30，可预先置于杆24上。在一个或多个蒂螺钉22插入骨中后，可放置带有预置主体零件(多数)28和环(多数)30的杆24，以使主体零件(多数)28位于蒂螺钉(多数)22上，如上所述。
冠词“一”、“一个”、“所述”和“这个”不是限制于单个零件，其包括一个或多个这种零件。

Claims (9)

1.一种矫形器械，包括：
具有固定部分和杆部分的骨固定件；
纵向零件；
具有主体零件和可压缩环的锁定组件，所述组件连接所述骨固定件和所述纵向零件；和
连接于所述主体零件的固定螺钉；
其中，所述主体零件包括被连接部分连接并被狭槽分离的下部和上部，所述下部和所述上部各包括第一孔和第二孔，所述第一孔的构造使所述骨固定件的所述杆部分能通过其中，所述第二孔的构造使所述固定螺钉可插入其中以压缩所述主体零件，所述主体零件还包括容纳所述可压缩环和一部分所述纵向零件的空腔；
其中，所述可压缩环包括中央通道以接受一部分所述纵向零件，
其中，所述固定螺钉对所述主体零件的压缩使所述可压缩环和纵向零件相对于所述主体零件，以及所述骨固定件相对于所述主体零件锁定在所需位置，和
其中，所述可压缩环还包括至少一个邻近纵向狭槽的凸起。
2.如权利要求1所述的矫形器械，其特征在于，所述第一孔有光滑壁。
3.如权利要求1所述的矫形器械，其特征在于，所述骨固定件是蒂螺钉。
4.如权利要求1所述的矫形器械，其特征在于，所述纵向零件是脊柱杆。
5.如权利要求1所述的矫形器械，其特征在于，所述固定螺钉包括可分离头部分。
6.如权利要求1所述的矫形器械，其特征在于，所述可压缩环还包括纵向狭槽。
7.如权利要求6所述的矫形器械，其特征在于，所述可压缩环还包括环绕所述可压缩环的轴线与所述纵向狭槽相对的槽。
8.如权利要求1所述的矫形器械，其特征在于，所述可压缩环还包括两个邻近所述纵向狭槽的凸起。
9.如权利要求6所述的矫形器械，其特征在于，所述中央通道还包括具有至少一个边缘表面的壁部分。
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KR20060012325A (ko) 2006-02-07
US20040254574A1 (en) 2004-12-16
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WO2004110289A1 (en) 2004-12-23
US7270665B2 (en) 2007-09-18
ATE398972T1 (de) 2008-07-15
AU2004247116A1 (en) 2004-12-23
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CA2528515A1 (en) 2004-12-23

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