CN101342087A - 用于以侵入性最小的方式放置脊椎固定元件的方法和装置 - Google Patents

用于以侵入性最小的方式放置脊椎固定元件的方法和装置 Download PDF

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CN101342087A
CN101342087A CNA200810213200XA CN200810213200A CN101342087A CN 101342087 A CN101342087 A CN 101342087A CN A200810213200X A CNA200810213200X A CN A200810213200XA CN 200810213200 A CN200810213200 A CN 200810213200A CN 101342087 A CN101342087 A CN 101342087A
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spinal fixation
fixation element
vertebra
anchoring piece
access device
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CN101342087B (zh
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D·G·安德森
C·W·西克沃尔
G·J·罗斯
S·P·塞洛弗
N·M·希伊
R·A·鲁伯特
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DePuy Spine LLC
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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
    • 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
    • A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A61B17/7083—Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements
    • A61B17/7085—Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements for insertion of a longitudinal element down one or more hollow screw or hook extensions, i.e. at least a part of the element within an extension has a component of movement parallel to the extension's axis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • 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
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7011—Longitudinal element being non-straight, e.g. curved, angled or branched
    • 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
    • A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S606/00—Surgery
    • Y10S606/914—Toolkit for installing or removing spinal positioner or stabilizer

Abstract

一种用于将脊椎固定元件引入到患者的身体内的经皮进入装置，其包括：适合于经皮递送以与脊椎植入物配合起来并且包括近端和远端的伸长的大体上是圆柱形的管道；在伸长的大体上是圆柱形的管道的近端和远端之间延伸的内腔，内腔适合于在大致上平行于内腔的纵向轴线的第一方向上传送经过其的脊椎固定元件，并且适合于在不同于第一方向的第二方向上将脊椎固定元件递送到脊椎锚固件位点内；和至少一个从伸长的大体上是圆柱形的管道的远端延伸经过其至少部分的用于有助于将脊椎固定元件从第一方向转换到第二方向的侧壁开口。

Description

用于以侵入性最小的方式放置脊椎固定元件的方法和装置
技术领域
本申请涉及在脊椎手术中使用的工具，并且特别地涉及用于将脊椎固定元件引入到一个或多个在患者的脊椎内的脊椎锚固件位点的侵入性最小的方法和装置。
背景技术
由于许多已知的原因，脊椎固定装置在整形外科手术中使用，以使在邻近的椎骨主体之间的想要的关系对准和/或固定。这样的装置典型地包括脊椎固定元件例如相对刚性的固定杆，通过将元件接附到多种锚固装置例如钩、栓、线或螺钉，脊椎固定元件连结到邻近的椎骨。固定元件可以具有根据目标植入位点的性质设计的预定轮廓，并且一旦安装好了，器械就使椎骨保持成想要的空间关系，直到实现了想要的康复或脊椎融合，或持续一段较长的时间。
脊椎固定元件可以锚固到椎骨的特定部分。由于每块椎骨的形状和尺寸都是不同的，所以多种锚固装置已经开发出来，以有助于接合骨的特别部分。例如，椎弓根螺钉组件的形状和尺寸构造为接合椎弓根骨。这样的螺钉典型地包括适合于旋拧到椎骨内的带有螺纹的柄和具有杆接收元件的头部部分，杆接收元件的形式通常为形成在头部内的U形槽。固定螺钉、塞子或类似类型的紧固机构用于将固定元件例如脊椎杆锁定到椎弓根螺钉的杆接收头部内。在使用时，每个螺钉的柄部分都旋拧到椎骨内，并且一旦进行了适当的定位，杆就安放经过每个螺钉的杆接收部件，并且通过使帽或其它固定器机构收紧，杆锁定在适当的位置，以使每个螺钉和固定杆都牢靠地相互连接起来。
近来，脊椎手术的趋势朝向以下方面发展：提供侵入性最小的用于植入脊椎固定装置的装置和方法。例如，在编号为6,530,929的Justis等人的美国专利中，披露了一种这样的方法，并且它使用两个经皮进入装置，用于将锚固装置例如脊椎螺钉植入到邻近的椎骨内。脊椎杆然后引入经过距经皮进入位点某个距离的第三切口，并且杆横向地移动到每个脊椎螺钉的杆接合部分内。经皮进入装置然后可以用于将闭合机构应用到杆接和头部，以锁定在其内的杆。尽管这种过程优于现有技术的侵入性技术，但横向地将杆引入可能对周围的组织和肌肉造成严重的损害。而且，使用三个分开的进入位点可能不合乎人们意愿地使手术过程延长，并且使患者的损伤和恢复时间增加。
因此，需要对用于将脊椎固定元件引入到患者的脊椎内的侵入性最小的装置和方法进行改进。
发明内容
在这里所披露的内容是用于将脊椎固定元件递送到一个或多个在患者的脊柱内的脊椎锚固件位点的侵入性最小的方法和装置。在一个实施例中，所提供的侵入性最小的手术方法包括形成经过位于在患者的脊柱内的椎骨附近的组织的切口，并且将工具的钝顶插入经过切口，同时沿着在切口和椎骨之间延伸的肌肉平面操纵工具，以将肌肉分开。钝顶优选地具有大致上平的构形，或它包括至少一个大致上平的表面。在示范性的实施例中，工具的钝顶适合于将胸最长肌和多裂肌分开。方法也可以包括将引导线插入经过延伸经过工具的内腔。引导线优选地定位，从而使它延伸到椎骨内。一旦进行了适当的定位，工具就可以移开，而将引导线留在适当的位置，以接收优选地沿着引导线递送到椎骨的脊椎植入物例如脊椎锚固件。上述的方法可以重复进行，以将一个或多个额外的植入物递送到邻近的椎骨。脊椎固定元件例如脊椎杆然后可以沿着延伸到椎骨主体的路径中的一条递送，并且它可以连结到植入在邻近的椎骨内的植入物。在示范性的实施例中，固定元件可以在大致上平行于第一路径的纵向轴线的方向上插入经过路径中的一条。在某些示范性的实施例中，脊椎固定元件可以递送经过沿着从组织表面到椎骨中的一块的路径延伸的套管。
在另一个示范性的实施例中，在脊椎手术中使用的医用装置套件可以包括具有形成在其远端的钝的部件并且适合于在不对肌肉造成损害的情况下沿着肌肉平面将肌肉分开的组织解剖工具。示范性的组织解剖工具可以包括延伸经过其的内腔。套件也可以包括至少一条适合于布置经过在组织解剖工具内的内腔的引导线和至少一个适合于植入在椎骨主体内的脊椎锚固件。套件也可以包括至少一个适合于提供从组织表面到椎骨主体的用于将脊椎锚固件递送到椎骨主体的路径的套管和/或至少一个适合于连结到至少两个脊椎锚固件并且在至少两个脊椎锚固件之间延伸的脊椎固定元件。
在本发明的又一个实施例中，具有与其配合的经皮进入装置并且具有延伸经过其并且限定了纵向轴线的内腔的脊椎锚固件经皮递送到椎骨主体。脊椎固定元件然后在固定元件大致上平行于经皮进入装置的纵向轴线的第一长度方向上，前进经过在经皮进入装置内的内腔。脊椎固定元件然后可以受到操纵，以在第二方向上延伸，从而使固定元件与第一方向成某个角度，以相对于脊椎锚固件定位脊椎固定元件。方法也可以包括以下步骤：用与其配合的第二经皮进入装置经皮将第二脊椎锚固件递送到椎骨主体。脊椎固定元件因而优选地在第二方向上在第一脊椎锚固件和第二脊椎锚固件之间延伸。
在示范性的实施例中，经皮进入装置的形式为伸长的大体上是圆柱形的适合于经皮递送并且适合于与脊椎锚固件配合的管道。管道可以包括带有延伸在其之间的内腔的近端和远端。内腔适合于在大致上平行于经皮进入装置的纵向轴线的第一长度方向上，经过其传送脊椎固定元件，并且适合于在与第一方向成某个角度的并且较优选地是大致上平行于患者的脊柱的第二方向上，将脊椎固定元件递送到脊椎锚固件位点。经皮进入装置也可以包括至少一个从伸长的大体上是圆柱形的管道的远端延伸经过其至少部分的侧壁开口，以有助于将脊椎固定元件从第一方向转换到第二方向。在一个实施例中，装置包括形成在其内的邻近其远端的相对的侧壁开口。装置也可以可选择地或者替代地包括形成在内腔内的适合于将布置在其内的脊椎固定元件从第一方向指引到第二方向的引导部件。例如，引导部件可以是形成在经皮进入装置的内腔内的倾斜的架子。
在本发明的另一个实施例中，提供了用于将脊椎固定元件递送到在患者的脊柱内的脊椎锚固件位点的侵入性最小的方法。方法包括以下步骤：将脊椎固定元件引入到经皮进入装置的内腔内。内腔优选地形成了到达在患者的椎骨内的脊椎锚固件的路径。在示范性的实施例中，经皮进入装置所具有的外部直径大致上与它所接附到的脊椎锚固件的最大宽度相同或小于这个宽度。本领域的技术人员应该意识到的是，经皮进入装置的外部直径可以可选择地大于它所接附到的脊椎锚固件的外部直径。方法还包括以下步骤：在大致上平行于经皮进入装置的纵向轴线的第一长度方向上，使脊椎固定元件在远端方向上前进经过内腔，并且操纵脊椎固定元件为在大致上平行于患者的脊柱的第二方向上。脊椎固定元件然后可以相对于一个或多个脊椎锚固件进行定位。
在本发明的其它方面内，所提供的侵入性最小的手术方法包括以下步骤：在患者体内制造第一经皮切口，并且形成从第一经皮切口到在第一椎骨主体上的锚固件位点的第一路径。优选地，路径是侵入性最小的路径，从而使它只是通到单一的锚固件位点而不是通到多个锚固件位点。例如，通过具有大致上统一的从第一经皮切口到在第一椎骨主体上的第一锚固件位点的宽度的经皮进入装置，这可以实现。在示范性的实施例中，第一路径所具有的宽度大致上等于第一经皮切口的宽度或小于这个宽度，和/或大致上等于第一锚固件的宽度或小于这个宽度。方法也包括以下步骤：将第一锚固件放置经过第一经皮切口，使第一锚固件沿着第一路径前进到单一的锚固件位点，并且在大致上平行于第一路径的纵向轴线的方向上，将固定元件放置经过第一路径。
在再一个实施例中，第二经皮切口可以在患者体内制造，并且从第二经皮切口到在第二椎骨主体上的第二锚固件位点的第二侵入性最小的路径可以形成。第二锚固件然后沿着第二路径前进到在第二椎骨主体上的第二锚固件位点。
也提供了额外的用于将脊椎固定元件引入到一个或多个脊椎锚固件位点的方法和装置。
附图说明
图1是根据本发明的一个实施例的连结到锚固件的经皮进入装置的透视图；
图2是沿着图1所示的经皮进入装置的纵向轴线所做的截面图；
图3A是具有形成在其内的引导部件的经皮进入装置的另一个实施例的部分剖开图；
图3B是图3A所示的具有围绕其布置的套筒和与其配合的脊椎锚固件的经皮进入装置的部分剖开图；
图4A是三个形成在患者背部的胸腰筋膜内的经皮切口的后视图；
图4B是六个形成在患者背部的胸腰筋膜内的经皮切口的后视图；
图5A是显示了对围绕患者椎骨的肌肉进行钝器解剖的端视图；
图5B是图5A所示的椎骨的端视图，显示了使用手指用于沿着所解剖的肌肉平面将肌肉分开以进入椎骨的技术；
图5C是图5A所示的椎骨的端视图，显示了使用工具用于沿着所解剖的肌肉平面将肌肉分开以进入椎骨的技术的另一个实施例；
图5D是图5C所示的椎骨的端视图，显示了进一步沿着所解剖的肌肉平面插入的工具；
图5E是图5C所示的椎骨的端视图，显示了将引导线放置经过工具并且进到患者的椎骨内；
图5F是图5C-5E所示的工具的侧视图；
图5G是图5F所示的沿着线A-A所做的截面图；
图6是图4所示的椎骨的端视图，显示了将引导线放置经过切口并且以进到患者的椎骨内；
图7是图6所示的椎骨的端视图，具有闭塞器和若干布置在引导线之上以使组织和肌肉扩张的扩张器；
图8是植入在椎骨内并且具有连结到其并且延伸经过形成在患者的组织表面内的经皮切口的经皮进入装置的第一脊椎锚固件和植入到邻近的椎骨内并且具有连结到其的带有延伸经过其的驱动器工具的经皮进入装置的第二脊椎锚固件的透视图；
图9是两个接附到布置在处在患者的脊柱内的邻近的椎骨内的脊椎锚固件的经皮进入装置的透视图；
图10图示了用于将脊椎固定元件引入经过图9所示的经皮进入装置中的一个的部分剖开图的方法；
图11是图10所示的使用推动器装置而朝向脊椎锚固件前进的脊椎固定元件的透视图；
图12是图11所示的在其完全定位在邻近的脊椎锚固件的接收器头部内之后的脊椎固定元件的透视图；
图13图示了用于将脊椎固定元件引入经过图3A和3B所示的经皮进入装置的部分剖开图的方法；
图14是图13所示的使用推动器装置而朝向脊椎锚固件前进的脊椎固定元件的透视图；
图15是图14所示的进一步朝向邻近的脊椎锚固件的接收器头部前进的脊椎固定元件的透视图；
图16是图15所示的将要布置在邻近的脊椎锚固件的接收器头部内的脊椎固定元件的透视图；和
图17是围绕图12所示的经皮进入装置定位并且压缩装置朝向彼此的压缩工具和应用经过经皮进入装置中的一个以相对于脊椎锚固件锁定脊椎固定元件的闭合机构的透视图。
具体实施方式
本发明提供了用于将脊椎固定元件引入到在患者的脊柱内的手术位点内的侵入性最小的方法和装置。大体上，方法牵涉以下步骤：在长度方向上，使脊椎固定元件沿着从侵入性最小的经皮切口延伸到脊椎锚固件位点的侵入性最小的路径前进。在示范性的实施例中，经皮进入装置用于形成用于接收脊椎固定元件并且用于将固定元件递送到脊椎锚固件位点的侵入性最小的路径。脊椎固定元件优选地在长度方向上插入经过在经皮进入装置内的内腔，从而使脊椎固定元件定向成大致上平行于经皮进入装置的纵向轴线。当脊椎固定元件接近或到达路径的远端的时候，脊椎固定元件可以受到操纵，以相对于经皮进入装置将它定向在想要的角度，从而优选地使脊椎固定元件大致上平行于患者的脊柱。脊椎固定元件然后可以可选择地定位，以将它直接地或间接地连结到一个或多个脊椎锚固件。如果需要的话，紧固元件或其它闭合机构然后可以引入到脊椎锚固件位点内，以固定地使脊椎固定元件与锚固件(多个锚固件)配合起来。
由于本发明的方法和装置可以通过使用一个或多个侵入性最小的经皮切口以进入脊柱而实现，所以本发明的方法和装置是特别有利的。这样的切口使对所介入的组织的损害最小化，并且它们使恢复时间和术后疼痛减少。本发明也有利地提供了用于沿着侵入性最小的路径递送脊椎固定元件和锚固件的技术，因而无需在手术位点形成大的工作区域。
尽管多种装置可以用于实施本发明的方法，但图1和2图示了与脊椎锚固件50(图1)配合以形成脊椎植入组件10的经皮进入装置12的示范性的实施例。像所显示的那样，装置12的形式为大体上伸长的圆柱形的具有形成在其内并且限定了在近端12a和远端12b之间延伸的纵向轴线L的内部内腔12c的管道。基于所意图的用途，进入装置12的尺寸可以发生变化，但它的长度1应该允许进入装置12的近端12a定位在患者的身体外侧，同时进入装置12的远端12b连结到布置在位于患者的脊椎内的椎骨内的脊椎锚固件例如锚固件50或定位在这个锚固件附近。进入装置12也优选地适合于提供用于递送脊椎固定元件的侵入性最小的路径，并且特别地，经皮进入装置12也应该适合于植入经过侵入性最小的经皮切口，经皮切口是相对小的典型地具有小于所插入经过的装置的直径或宽度的长度的切口。
在示范性的实施例中，装置12所具有的内部直径di足以允许脊椎固定元件优选地在长度方向上引入经过其。内部直径di也可以可选择地构造为允许驱动器机构引入经过其，用于应用闭合机构，以相对于脊椎锚固件锁定脊椎固定元件。进入装置12的外部直径do也可以发生变化，并且它可以与脊椎锚固件的外部直径dr相同、小于脊椎锚固件的外部直径dr或大于脊椎锚固件的外部直径dr。在所图示的实施例中，进入装置12所具有的外部直径do大致上与脊椎锚固件的外部直径dr相同，如图1所示，脊椎锚固件是脊椎螺钉50的接收器头部52。由于切口的尺寸无需较所需要的大，所以这是特别有利的。匹配的进入装置12的外部直径do和锚固件50的外部直径dr也允许进入装置12和/或锚固件50引入经过套管。如果进入装置12与锚固件50配合起来，那么匹配的外部直径do、dr也允许套筒或其它装置可滑动地围绕其布置，以防止在进入装置12和锚固件50之间的脱离。在另一个示范性的实施例中，进入装置12的外部直径do可以稍微大于脊椎锚固件的外部直径dr。作为非限制性的例子，在脊椎锚固件的接收器头部所具有的外部直径dr为大约13mm的情况下，进入装置12所优选具有的外部直径do为大约15mm。
经皮进入装置12也优选地包括至少一个形成在其内的侧壁开口或槽14，并且较优选地，它包括两个形成在其内并且从其远端12b在近端方向上延伸的相对的侧壁开口(只显示了一个开口14)。开口14允许脊椎固定元件在脊椎固定元件大致上平行于进入装置12的纵向轴线L的第一长度方向上引入经过装置12。脊椎固定元件然后可以受到操纵，以延伸成与第一方向成某个角度，从而使固定元件在大致上横向于进入装置12的纵向轴线L的方向上例如在大致上平行于患者的脊椎的方向上延伸。由于脊椎固定元件的长度L必须大于进入装置12的内部直径di，所以开口14允许脊椎固定元件经过其，同时从第一长度方向转换到第二方向。本领域的技术人员应该意识到的是，基于脊椎固定元件的构形，脊椎固定元件相对于纵向轴线L的确切位置当然可以发生变化。
每个开口14的形状和尺寸都可以发生变化，但开口(多个开口)14应该有效地允许脊椎固定元件从第一方向移动到第二方向。在示范性的实施例中，开口14在大约一半的经皮进入装置12的长度或小于一半的经皮进入装置12的长度上延伸。每个槽14的形状都可以是大体上伸长的，并且它们每个所应该具有的宽度w都足以适应脊椎固定元件的直径。本领域的技术人员应该意识到的是，经皮进入装置12可以包括任何数目的具有任何足以允许脊椎固定元件从第一方向移动到第二方向的形状的侧壁开口。
在图3A-3B所示的本发明的另一个实施例中，经皮进入装置112也可以可选择地包括形成在内腔112c的远端112b内的引导部件120，以有助于将脊椎固定元件从第一方向引导到第二方向。引导部件120可以具有多种构形，但它应该有效地将脊椎固定元件从第一方向引导朝向接附到进入装置112或定位在进入装置112附近的锚固件50并且可选择地朝向植入在邻近的椎骨内的锚固件(多个锚固件)。在示范性的实施例中，像所显示的那样，引导部件120的形式为形成在进入装置112的内部内腔112c内并且优选地定位成与形成在进入装置112内的单一的侧壁槽114相对的倾斜的架子。基于所使用的固定元件的类型和/或进入装置的几何形状，倾斜的架子120的形状和尺寸可以发生变化。在使用时，当脊椎固定元件例如脊椎杆的前端接触架子120的时候，架子120开始将脊椎固定元件指引到第二方向，由此使脊椎固定元件在大致上横向于装置112的轴线L并且优选地大致上平行于患者的脊柱的方向上延伸。脊椎固定元件然后可以受到操纵，以像在下面所较详细讨论的那样，相对于一个或多个脊椎锚固件对它进行定位。
返回参考图1，在使用时，经皮进入装置12可以适合于接附到脊椎锚固件50。因此，经皮进入装置12的远端12c可以包括一个或多个形成在其上或其内的配合元件18，用于接合锚固件50。例如，适宜的配合元件包括螺纹、扭曲锁定接合、卡扣接合或任何其它在本领域中所已知的技术，并且在示范性的实施例中，配合元件形成在进入装置12的远端12b的相对的内部表面上。优选地具有与形成在经皮进入装置12内的侧壁开口14相应的侧壁开口(未显示)的套筒100(在图3B中部分显示)或其它装置也可以放置在经皮进入装置12之上，可选地也放置在植入物50上，以在使用期间，防止进入装置12与植入物50脱离。在与其同时提交的题目为“Percutaneous Access Devices andBone Anchor Assemblies”的专利申请中，披露了用于使经皮进入装置12与锚固件配合起来的示范性的技术。本领域的技术人员应该意识到的是，多种其它技术可以用于可移开地使经皮进入装置与锚固件匹配起来。
为了参考，图1图示了用于与本发明的方法和装置一起使用的示范性的脊椎锚固件。本领域的技术人员应该意识到的是，多种锚固件包括例如脊椎螺钉、钩、栓和线可以与本发明的装置和方法一起使用。图1所图示的脊椎螺钉包括在远端的骨接合部分例如带有螺纹的柄54和在近端的适合于安放优选地为脊椎杆(未显示)的脊椎固定元件的U形接收器头部52。带有螺纹的柄54可以固定地接附到接收器头部52，以形成单轴的螺钉，或可选择地，像所显示的那样，柄54可以构造为可转动地布置经过形成在接收器头部52的远端内的开口以允许柄54相对于接收器头部52进行转动的多轴的螺钉。多种技术可以使用，以允许头部52相对于柄54进行转动。
图4A-17显示了植入脊椎固定元件的侵入性最小的方法。尽管方法与在这里所披露的经皮进入装置12和脊椎螺钉50一起显示和描述，但本领域的技术人员应该意识到的是，方法没有受到与这样的装置一起使用的限制，并且多种其它在本领域中所已知的装置可以使用。而且，尽管在图4-14中只显示了两个进入装置12、12’和两个锚固件50、50’，但本发明的方法可以通过使用任何数目的进入装置和锚固件而实施。方法也可以通过只使用在这里所披露的方法步骤中的一些和/或通过使用其它在本领域中所已知的方法而实施。
过程优选地以形成经过位于想要的植入位点附近的组织的侵入性最小的经皮切口开始。尽管切口的位置、形状和尺寸基于所植入的脊椎锚固件的类型和数量，但图4A图示了三个形成在位于患者背部的胸腰筋膜内的三个邻近椎骨的一侧的侵入性最小的中线经皮切口62a-c，而图4B图示了三个形成在位于患者背部的胸腰筋膜内的三个邻近椎骨的相对侧的额外的侵入性最小的中线经皮切口62d-f。每个切口6a-f都是直径为大约10-20mm的穿刺切口，然而，基于过程，这可以发生变化。在示范性的实施例中，每个切口6a-f的直径都等于或小于所插入经过其的锚固件和/或经皮进入装置的最大直径。
尽管可能不是必需的，但如图5A-5B所示，一旦经皮切口62a-f形成，钝的手指解剖就可以可选择地使用，以将胸最长肌和多裂肌分开，由此将横突和上部关节突的面和结合处暴露出来。
图5C-5E图示了另一个示范性的用于通过使用钝的工具200而将胸最长肌和多裂肌分开的技术，在图5F-5G中，较详细地显示了钝的工具200。首先参考图5F-5G，工具200大体上包括具有近端202a和远端202b的刚性的伸长的轴202。轴202也包括延伸经过其的在近端202a和远端202b之间的内腔202c，用于接收引导线例如k线。内腔202c可以确定尺寸为接收递送经过内腔202c的引导线202c。近端202a可以包括形成在其内的把手204，以有助于握住工具200。把手204事实上可以具有任何形状和尺寸。例如，如图5F-5G所示，在示范性的实施例中的把手204具有大体上伸长的圆柱形的形状，并且它包括形成在其上的隆起204a，以有助于抓住装置。
工具200的远端202b包括形成在其上的钝的部件206。钝的部件206可以适合于例如确定尺寸和形状为沿着肌肉平面将肌肉分开，同时伴随地使对所分开的肌肉的损伤最小化。尽管钝的部件206的形状可以发生变化，但在示范性的实施例中，像所显示的那样，钝的部件206具有大致上伸长的矩形的带有相对的前部表面206a和后部表面206b的形状。在前部表面206a和后部表面206b之间的宽度可以在远端方向上逐渐变细或减小，从而使最远端的宽度wb2小于最近端的宽度wb1。这样的示范性的构形有助于将钝的部件206插入在组织例如肌肉之间，以允许组织分开。在前部表面206a和后部表面206b的相对的侧边缘之间延伸的宽度ws也可以发生变化，但在示范性的实施例中，像所显示的那样，宽度ws沿着前部表面206a和后部表面206b的长度是不变的。
尽管没有显示，但工具200也可以可选择地包括布置在伸长的轴202内的内部管道，用于使椎骨做好准备。特别地，内部管道可以可滑动地布置在伸长的轴202内，以允许内部管道在远端方向上移动到骨内，以在椎骨内形成痕迹，由此使骨为锥子或丝锥作好准备。工具200也可以可选择地作为钻子引导件。特别地，伸长的轴202所具有的内部直径适合于接收经过其的钻子，以将钻子引导朝向椎骨并且进到椎骨内。轴202也作为用于保护钻子的套管，避免在钻子和围绕工具200的肌肉之间的接触。本领域的技术人员应该意识到的是，工具200可以具有多种其它构形，并且工具200可以适合于多种其它用途。
现在参考图5C-5E，显示了在使用时的示范性的工具200。像所显示的那样，在经皮切口62a-f形成之后，像先前所描述的那样，解剖工具200的钝的部件206可以插入经过切口62。切口62的深度可以足以允许在胸最长肌和多裂肌之间的脂肪层确定位置。一旦确定了位置，工具200就可以受到操纵，以将胸最长肌和多裂肌分开或撕开，由此将横突和上部关节突的面和结合处暴露出来。一旦如图5D所示，工具200定位成邻近椎骨60或顶在椎骨60上，引导线例如k线64就可以插入经过在工具200内的内腔202c，以如图5E所示，将k线64的远端定位在椎骨60或定位在椎骨60内。荧光透视或其它成像可以使用，以有助于正确地放置k线64。工具200然后可以从k线64移开，而将k线64留下来作为用于多种其它装置的引导件，在下面，较详细地描述了多种其它装置。这个过程可以在每个切口62a-f重复进行，以有助于放置多个脊椎锚固件。
在工具200没有使用的情况下，引导线例如k线64可以在切口形成之前或在切口形成之后，植入在每个脊椎锚固件植入位点。如图6所示，k线64优选地在肌肉之间延伸，并且在脊椎锚固件的想要的进入点进到椎骨内。荧光成像可以使用，以有助于正确地放置k线64。
切口的相对的端部然后可以扩张，以提供用于将脊椎锚固件递送到每个植入位点的路径。图7图示了通过使用闭塞器66a而在切口62的一端进行的扩张，闭塞器66a具有放置在其上的若干尺寸增加的扩张器66b、66c。扩张器66b、66c在闭塞器66a和k线64上递送，以使围绕切口62的皮肤基本上伸展，并且使路径扩展到锚固件位点。
如图8所示，一旦切口62扩张到适当的尺寸，锚固件就可以递送到每个锚固件位点。这个过程典型地牵涉了通过使用一个或多个骨准备器械例如钻子、丝锥、锥子、磨锥、探针等而使椎骨60做好准备。尽管不总是必需的，但一个或多个套管可以用于提供从切口62到锚固件位点的路径，用于插入骨准备器械和/或锚固件。在示范性的实施例中，相对小的套管用于将骨准备器械引入到手术位点内。切口62然后可以进一步扩张，并且小的套管可以用适合于接收锚固件或与锚固件配合的较大的套管替换。
一旦椎骨60准备好了，脊椎锚固件就可以植入在每个植入位点。在锚固件50、50’插入到骨60、60’内之后，进入装置12、12’可以与每个锚固件50、50’配合，但更优选地，在锚固件50、50’插入到骨60、60’内之前，每个经皮进入装置12、12’接附到锚固件50、50’，以为用于将锚固件50驱动到骨60、60’内的驱动器工具提供路径。图8图示了植入在第一椎骨60内并且具有接附到其的进入装置12的锚固件50。尽管没有显示，但锚固件50优选地加套管，以允许k线64延伸经过锚固件50和进入装置12，以将装置50、12引导朝向植入位点。图8还图示了具有与其配合的进入装置12’的第二锚固件50’。像所显示的那样，螺钉50’将要植入在邻近第一椎骨60的第二椎骨60’内。一旦螺钉50’定位成邻近椎骨60’，驱动器工具90就可以定位经过进入装置12’，并且连结到螺钉50’的接收器头部52’，以将螺钉50’驱动到椎骨60’内。
在另一个实施例中，套筒可以在装置12、12’、50、50’植入之前或在装置12、12’、50、50’植入之后，放置在每个进入装置12、12’之上，以防止装置12、12’与它们所接附的锚固件50、50’脱离。图3B所部分图示的套筒100的形式优选地为具有与每个进入装置12、12’大致相同的构形的套管。在进入装置12、12’使用接合形成在每个螺钉头部52、52’的外部表面上的相应的棘爪的销部件的情况下，由于套筒可以防止销部件与棘爪脱离，所以使用套筒是特别合乎人们意愿的。套筒也可以可选择地作为进入装置，这允许进入装置12、12’从锚固件50、50’拆卸下来并且移开。
在锚固件50、50’植入之后，脊椎固定元件70递送到锚固件位点。通过将脊椎固定元件70引入经过接附到锚固件50、50’的经皮进入装置12、12’中的一个，或经过提供了到达锚固件(多个锚固件)50、50’的路径的一些其它经皮进入装置，这可以实现。如图9所示，脊椎固定元件例如脊椎杆70在第一长度方向上引入到装置12内，从而使脊椎固定元件70大致上平行于进入装置12的纵向轴线L。在固定元件具有弯曲的取向或它具有一些其它构形的情况下，应该理解的是，当固定元件定位成在长度方向经过经皮进入装置的时候，它处在“大致上平行的”方向上。
如图10和11所示，脊椎固定元件70然后在远端方向上朝向经皮进入装置12的远端12b移动。脊椎固定元件70的移动可以通过使用操纵器装置80而实现。操纵器装置80可以具有多种构形，但它应该有效地允许脊椎固定元件70的移动受到控制。本领域的技术人员应该意识到的是，多种其它技术可以用于将脊椎固定元件70引导经过经皮进入装置12，并且相对于一个或多个锚固件50、50’定位脊椎固定元件70。而且，脊椎固定元件70可以具有多种构形，以有助于插入经过经皮进入装置。作为非限制性的例子，题目为“Flexible Spinal FixationElements”并且与其同时提交的专利申请所披露的脊椎固定元件当它经过经皮进入装置的时候可以发生弯曲，由此允许脊椎固定元件从第一方向转换到第二方向。该申请也披露了用于沿着引导线或缆线递送脊椎固定元件的技术，因而不再需要操纵器装置。例如，除了机械的和柔性的固定元件之外，其它适宜于与本发明一起使用的脊椎固定元件包括可膨胀的固定元件例如那些在编号为2002/0068975的Teitelbaum等人的题目为“Formable Orthopedic Fixation Systemwith Cross Linking”的美国专利公开件、编号为2002/0082600的Shaolian等人的题目为“Formable Orthopedic Fixation Systems”的美国专利公开件和编号为2002/0198526的Shaolian等人的题目为“Formed In Place Fixation System with Thermal Acceleration”的美国专利公开件中所披露的固定元件，这些美国专利公开件中的每个都通过参考在此完全地合并。
现在参考图11和12，当脊椎固定元件70靠近进入装置12的远端12b的时候，脊椎固定元件70可以受到操纵，以使脊椎固定元件70采取与第一方向不同并且较优选地是大致上平行于患者的脊柱和/或横向于第一方向的第二方向。应该理解的是，基于所植入的固定装置的类型及进入装置12的方向，在第二方向上的固定元件的角度可以发生变化，由于进入装置12可以相对于患者的脊柱定位在若干角度，所以进入装置12的方向在整个手术过程中可以发生变化。
在脊椎固定元件70从第一方向转换到第二方向期间，脊椎固定元件70的前端应该在皮下定位。在进入装置12包括槽或开口(只显示了一个开口14)的情况下，开口(多个开口)14可以使用，以当它们允许脊椎固定元件70在进行转动期间延伸经过其的时候，有助于将脊椎固定元件70移动到第二方向。然而，基于开口14的长度、脊椎固定元件70的长度和/或脊椎固定元件70的构形，这可以不是必需的。如图11和12所示，只是脊椎固定元件70的前端70a经过开口14中的一个从经皮进入装置12出来。
参考图12，连续地对脊椎固定元件70进行操纵，直到脊椎固定元件70相对于一个或多个脊椎锚固件定位。基于所使用的脊椎锚固件的类型，固定元件可以定位成直接地或间接地与脊椎锚固件配合起来。如图12所示，固定元件70完全地安放在邻近的脊椎锚固件50、50’的接收器头部52、52’内。如果使用的话，操纵器装置80然后可以从进入装置12移开。
在另一个实施例中，图3A和3B所示的经皮进入装置112可以使用，以有助于将脊椎固定元件引入到手术锚固件位点内。像先前所陈述的那样，进入装置112包括形成在其内的引导部件20，以将脊椎固定元件70从第一方向指引到第二方向。这在图13-16中进行了图示。像所显示的那样，当脊椎固定元件70在远端方向上移动以与引导部件120发生接触的时候，引导部件120使脊椎固定元件70发生转动并且朝向在经皮进入装置112内的开口114延伸。因此，脊椎固定元件70指向第二方向，由此它可以定位在邻近的脊椎植入物50、50’的接收器头部52、52’内或定位在邻近的脊椎植入物50、50’的接收器头部52、52’附近。
返回参考图12，一旦脊椎固定元件70完全地安放在邻近的脊椎锚固件50、50’的接收器头部52、52’内，如果使用的话，推动器轴80然后就可以从脊椎固定元件70移开或拆卸下来，并且闭合机构就可以应用到接收器头部52、52’中的一个或两个，以在其内保持脊椎固定元件70。然而，在示范性的实施例中，在将闭合机构应用到每个锚固件50、50’之前，压缩工具100用于压缩进入装置12、12’朝向彼此。然而，在进行压缩之前，闭合机构(多个闭合机构)可以部分地应用。
在图17中，显示了示范性的压缩工具300，并且大体上，它所包括的相对的臂302、304彼此在其大致中点枢转地连结起来，从而使每个臂302、304都包括适合于围绕经皮进入装置12、12’布置的远端部分302b、304b和近端把手部分302a、304a。装置300也可以包括布置在臂302、304之间的支点(未显示)，以有助于臂302、304相对于彼此的移动受到控制。在使用时，每个臂302、304的远端部分302b、304b都放置成围绕进入装置12、12’，优选地围绕每个装置12、12’的远端12b、12b’和/或围绕每个锚固件50、50’的头部52、52’。如图17所示，近端把手部分302a、304a然后朝向彼此收拢，以使进入装置12、12’朝向彼此移动，优选地，同时维持在其之间的相对间隔。
一旦进行了适当的定位，闭合机构就可以优选地经由进入装置12、12’应用到每个锚固件头部50、50’，以使脊椎固定元件70保持在接收器头部52、52’内。多种闭合机构和用于递送闭合机构的工具在本领域中是已知的，并且它们可以与本发明一起使用。作为非限制性的例子，图13图示了布置经过进入装置12的驱动器工具90，用于将闭合机构例如固定螺钉应用到脊椎锚固件50的接收器头部52，以相对于脊椎锚固件50锁定脊椎固定元件70。对于邻近的脊椎锚固件(多个脊椎锚固件)，这个步骤可以重复进行。
本领域的技术人员应该意识到的是，脊椎固定元件70不必直接地接附到每个锚固件50、50’，并且它可以通过使用例如带夹或带有槽的或形成分支的连接器而间接地接附到锚固件50、50’。
一旦固定元件70相对于植入物50、50’固定，进入装置12、12’就可以从植入物50、50’移开，而只将每个进入装置12、12’引入的侵入性最小的经皮切口留在患者体内。由于它使对患者造成的损伤的量减小，并且它使对围绕手术位点的肌肉的损害最小化，所以这是特别有利的。
像先前所陈述的那样，本领域的技术人员应该意识到的是，方法可以以任何顺序通过使用任何步骤而实施。而且，本发明的进入装置可以用于同时或逐次递送多个脊椎固定元件，和/或用于进行多种其它在这里所没有图示或没有描述的手术过程。
基于上述的实施例，本领域的技术人员应该意识到本发明的其它特征和优点。因此，除了后附的权利要求书所指出的之外，本发明不受到所特别显示和描述的内容的限制。所有在这里所引用的公开件和参考都通过参考在这里明确地完全地合并。

Claims (8)

1.一种用于将脊椎固定元件引入到患者的身体内的经皮进入装置，其包括：
适合于经皮递送以与脊椎植入物配合起来并且包括近端和远端的伸长的大体上是圆柱形的管道；
在伸长的大体上是圆柱形的管道的近端和远端之间延伸的内腔，内腔适合于在大致上平行于内腔的纵向轴线的第一方向上传送经过其的脊椎固定元件，并且适合于在不同于第一方向的第二方向上将脊椎固定元件递送到脊椎锚固件位点内；和
至少一个从伸长的大体上是圆柱形的管道的远端延伸经过其至少部分的用于有助于将脊椎固定元件从第一方向转换到第二方向的侧壁开口。
2.根据权利要求1所述的经皮进入装置，其特征在于，内腔适合于在大致上平行于患者的脊柱的第二方向上递送脊椎固定元件。
3.根据权利要求1所述的经皮进入装置，其特征在于，伸长的大体上是圆柱形的管道包括形成在其内的邻近其远端的相对的侧壁开口。
4.根据权利要求1所述的经皮进入装置，其特征在于，伸长的大体上是圆柱形的管道的内腔包括适合于将布置其中的脊椎固定元件从第一方向指引到第二方向的引导部件。
5.根据权利要求4所述的经皮进入装置，其特征在于，引导部件包括形成在伸长的大体上是圆柱形的管道的内腔内的倾斜的架子。
6.根据权利要求5所述的经皮进入装置，其特征在于，倾斜的架子形成为恰好邻近伸长的大体上是圆柱形的管道的远端。
7.根据权利要求5所述的经皮进入装置，其特征在于，倾斜的架子定位在大致上与形成在伸长的大体上是圆柱形的管道内并且在近端方向上从其远端延伸的侧壁开口相对的位置。
8。根据权利要求1所述的经皮进入装置，其特征在于，伸长的大体上是圆柱形的管道的远端适合于可释放地与脊椎锚固件配合。
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