CN102512231B - 椎板间-棘突间脊椎稳定系统 - Google Patents

椎板间-棘突间脊椎稳定系统 Download PDF

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CN102512231B
CN102512231B CN201110412703.1A CN201110412703A CN102512231B CN 102512231 B CN102512231 B CN 102512231B CN 201110412703 A CN201110412703 A CN 201110412703A CN 102512231 B CN102512231 B CN 102512231B
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securing member
lateral sidewall
nut
spinous process
bone securing
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CN102512231A (zh
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F·T·特劳特魏因
R·列辛格
G·L·洛韦里
M·R·维斯科廖西
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Paradigm 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
    • 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
    • A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/1604—Chisels; Rongeurs; Punches; Stamps
    • A61B17/1606—Chisels; Rongeurs; Punches; Stamps of forceps type, i.e. having two jaw elements moving relative to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8665—Nuts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
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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
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    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A—HUMAN NECESSITIES
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    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/8875—Screwdrivers, spanners or wrenches
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/025—Joint distractors
    • A61B2017/0256—Joint distractors for the spine

Abstract

本发明提供了一种可植入的椎板间-棘突间稳定系统。该系统可包括U形的可植入装置，该可植入装置具有下部、上部、在所述下部和上部之间延伸的中部以及用于与椎骨的棘突接合的成对的侧向壁，每个侧向壁包括用于接纳骨紧固件的具有埋头孔的孔口。该系统还可包括骨紧固件，该骨紧固件包括螺栓和螺母以用于将可植入装置固定于棘突。可提供插入工具以使螺栓和螺母穿过可植入装置的孔口对准。

Description

椎板间-棘突间脊椎稳定系统
本申请是申请号为200780048956.7的中国专利申请的分案申请，原申请的申请日为2007年11月29日，发明创造名称为“椎板间-棘突间脊椎稳定系统”。
本申请要求2006年11月30日提交的U.S.临时申请No.60/868,080的优先权，其内容整体引用于此作为参考。
技术领域
本发明涉及用于治疗脊柱疾病的装置和方法，包括用于稳定相邻椎骨的椎板间-棘突间脊椎/椎骨稳定装置(interlaminar-interspinous vertebralstabilization device)以及使用这些装置的方法。
背景技术
脊柱疾病导致严重的病状。这些疾病包括椎骨、椎间盘、椎小关节和围绕脊柱的连接组织的异常。这些异常可能源于多种原因，包括机械损伤或椎间盘退变性疾病。这些异常可导致脊柱不稳定，使脊柱变得不齐整并在相邻椎骨间产生微动。脊椎不齐整和微动可能导致脊椎骨表面磨损并最终引起剧烈的疼痛。此外，这些疾病常常是慢性的和会逐渐加重的问题。
对于脊柱疾病的治疗可包括长期的医药治疗或外科手术。医药治疗通常旨在控制病症如疼痛，而非矫正根本的问题。对于某些患者来说，这可能需要长期使用止痛药，而这可能改变患者的精神状态或引起其它不利的副作用。
近来已可应用多种棘突间稳定装置。这些装置可植入在两个或多个相邻椎骨的棘突之间。通过这样稳定棘突，可从椎间盘上消除较大的压力以防止病情加重或改善病情，如椎管狭窄。此外，可对脊椎运动进行控制而不用显著改变脊柱的解剖学构造。
现有可用的棘突间稳定系统可使用多种不同机构固定在相邻的棘突之间。例如，这种装置可包括尖锐的倒钩或与棘突的骨表面接合的其它表面突起。此外，可在植入物和相邻的骨骼的周围安置柔性的韧带或缝线。但是，需要向棘突提供更加刚性和牢固的连接。例如，需要刚性连接以防止棘突间装置移动或滑动到不适当的位置。此外，还需要刚性连接以限制选定的脊椎水平/高度(vertebral level)处的运动并促进该脊椎水平处的融合。此外也希望提供一种还可在相邻的椎骨之间装配于椎板间的装置，从而增强该区域的稳定性。
本发明描述了一种椎板间-棘突间脊椎稳定系统，该系统易于植入并可牢固地附接于棘突上，同时安置在椎板间。
发明内容
本发明描述了一种用于治疗脊柱不稳定疾病的椎板间-棘突间脊椎稳定系统和使用这种系统的方法。该系统包括适于安置在相邻椎骨的棘突之间的椎板间-棘突间脊椎稳定装置和用于将该装置固定于棘突的骨紧固件。还提供了使用这种系统的插入工具和方法。
本发明的一个方面包括一种可植入的椎板间-棘突间稳定系统。该系统可包括U形的可植入装置，该可植入装置具有下部、上部、在下部和上部之间延伸的中部以及用于与椎骨的棘突接合的成对的侧向壁，每个侧向壁包括用于接纳骨紧固件的具有埋头孔的孔口。该系统还可包括骨紧固件，该骨紧固件包括用于将可植入装置固定于棘突的螺旋件和螺母。此外，可提供插入工具以用于在组装骨紧固件期间使螺旋件和螺母穿过可植入装置的孔口适当地对准。
本发明的第二方面包括一种可植入的椎板间-棘突间稳定系统。该系统可包括可植入装置，该可植入装置具有下部、上部和成对的侧向壁，所述成对的侧向壁从下部和上部中的至少一个伸出以便与椎骨的棘突接合。在下部和上部之间延伸的U形中部使得该装置能够在两个相邻椎骨之间定位在椎板间。每个侧向壁可包括用于接纳骨紧固件的孔口。该系统还可包括骨紧固件和插入工具，该骨紧固件包括用于将可植入装置固定于棘突的螺栓和螺母，该插入工具用于使螺栓和螺母穿过可植入装置的孔口对准。
本发明的第三方面包括一种稳定脊柱的方法。该方法可包括选择待治疗的脊椎水平和将U形植入物安置在选定的脊椎水平的两个棘突之间。该植入物可包括下部、上部、在上部和下部之间延伸的、构造成安置在椎板间的中部，以及从下部和上部中的至少一个伸出的第一对侧向壁。所述侧向壁安置在选定的脊椎水平的棘突之一的相对两侧。此外，每个侧向壁可包括用于接纳骨紧固件的孔口，且可这样将植入物固定在棘突中的至少一个上：将螺栓穿过侧向壁中的一个的孔口，并将螺母穿过位于棘突的相对侧上的侧向壁的孔口，使得螺母和螺栓穿过棘突并以螺纹连接相结合。
应当理解，上述一般性说明和下面的详细说明都仅为示例性和说明性的，而非对权利要求所要求保护的本发明构成限制。
结合在本说明书中并构成本说明书一部分的附图示出本发明的数个实施例，并与所作说明一起用于解释本发明的原理。
本发明的其它目的和优点将在下面的说明中部分阐述，或者可通过本发明的实施而被认识到。通过在所附权利要求中特别指出的要素及组合可实现和获得本发明的目的和优点。
附图说明
图1示出椎板间-棘突间脊椎稳定系统的示例性实施例的透视图；
图2A示出图1所示的系统的可植入装置的侧视图；
图2B示出图2A的装置沿线A-A截取的剖切后视图；
图2C是示出图2B的细节的放大图；
图3示出图1所示的椎板间-棘突间脊椎稳定系统的骨紧固件的透视图；
图4A示出插入工具的侧视图，该插入工具可与根据一个示例性实施例的椎板间-棘突间脊椎稳定系统一起使用；
图4B示出图4A的插入工具的俯视图；
图5A示出带有图3的骨紧固件的图4A和4B的插入工具的侧视图；
图5B示出图5A的插入工具的一部分和骨紧固件的一部分的放大图；
图5C示出图5A的插入工具的另一部分和骨紧固件的另一部分的另一放大图；
图6A示出可与图1的椎板间-棘突间脊椎稳定系统一起使用的拧紧器具的侧视图；
图6B示出图6A的拧紧器具的端部的放大图；
图7示出与图6A的拧紧器具一起使用的图5A的插入工具和图5B的骨紧固件的透视图；
图8示出图5A的插入工具和图3的骨紧固件的透视图；
图9是利用本发明的插入工具和拧紧器具植入稳定系统的透视图；
图10是根据一个示例性实施例的部分组装的棘突间系统的透视图；
图11A示出可在植入本发明的椎板间-棘突间脊椎稳定系统期间使用的打孔工具的透视图；
图11B示出图11A的打孔工具的放大图；
图12示出可在植入本发明的椎板间-棘突间脊椎稳定系统期间使用的一把压缩钳；
图13示出植入本发明的椎板间-棘突间脊椎稳定系统期间的图12的压缩钳。
具体实施方式
图1示出用于稳定相邻椎骨的可植入的椎板间-棘突间脊椎稳定系统10。该系统10包括构造成安置在相邻椎骨的棘突之间的可植入装置20。该装置可包括用于将该装置固定于棘突的一个或多个骨锚固件。此外，在一个实施例中，骨锚固件可相对于棘突刚性地固定该装置，从而限制选定的脊椎水平处的运动并促进此脊椎水平处的融合。
该装置20可包括间隔体。该间隔体20可具有各种不同的形状和厚度，并可由各种不同的材料制成。如图1所示，在一个实施例中，间隔体20可包括在下部32和上部34之间延伸的中部30。在被植入患者体内时，上部34构造成与第一棘突的一部分接触，而下部32构造成与相邻的第二棘突的一部分接触。如图所示，在一个实施例中，中部30、下部32和上部34可共同形成大致为U形的间隔体20。间隔体20可通过例如设置可伸展和/或可压缩的中部30而构造成柔性的和/或可弯曲的。该中部30可用作柔性铰链，使得上部34和下部32可相互离开或靠近地移动。此外，U形的间隔体使得装置10在植入后可安置或装配在椎板间，从而增强相邻椎骨的稳定性。
如图1所示，为了与相邻椎骨的棘突接合，间隔体20可设置有从下部和上部32、34伸出的一对侧向壁或支架36。该对侧向壁36的每一个都限定用于接纳棘突的镫形件38。可为该间隔体20设置不同尺寸或高度的侧向壁36以便适应患者身体构造的变化。同样，不同间隔体20的侧向壁36可设置在沿下部32或上部34长度的不同位置处。由此外科医生可根据待支承的特定脊椎水平和患者的身体构造选择适当地设定形状和尺寸的间隔体20。
此外，侧向壁36也可相对于间隔体20进行调节。例如，在一个实施例中，侧向壁36可由具有韧性/延展性的(malleable)材料制成，使得在植入之后外科医生可将侧向壁36压缩到一起以减小侧向壁36之间的间隙，从而将间隔体20牢牢地固定在位于其中的棘突上。此外，如图1的位于下方的侧向壁36所示，侧向壁36可被展开以便有利于插入。例如，可使用外科手术钳或镊子使侧向壁36压缩或展开。
多种生物相容性材料适合用于形成本发明的间隔体20。例如，在一个实施例中，间隔体20可由医用等级的金属如钛或钛合金形成。间隔体20还可由多种其它材料例如不锈钢、钴铬合金、陶瓷和/或聚合材料如超高分子量聚乙烯(UHMWPE)和聚醚醚酮(PEEK)形成，这些材料或单独使用，或与其它适当的材料结合使用。
为了进一步增强装置10固定到周围的骨骼和软组织上的能力，装置10可包括多种表面变型。例如，间隔体20可包括有利于组织连接、结合或固定的表面变动。这些表面变动可包括齿、倒钩、凸缘、表面粗糙化或向装置10的一个或多个部分添加生物活性剂。例如，装置10可包括用于将装置10紧固在骨骼和/或软组织上的一个或多个倒钩40。如图所示，倒钩40可位于间隔体20上，例如位于下部32和/或上部34的外表面上。作为替换地或附加地，倒钩40可位于侧向壁36的内表面上。倒钩40可有助于将间隔体20牢固地接合于椎骨的连接组织或骨面，例如椎骨的棘突。
此外，装置10还可包括粗糙的或多孔的表面。粗糙的或多孔的表面可增强植入物表面与骨骼之间的连接。此外，某些多孔表面可促进组织向内生长以在装置10的各部分与周围的骨骼和/或软组织之间形成生物结合。粗糙的或多孔的表面可包括在装置10的任意部分上。
装置10的表面还可包括生物活性剂。这些活性剂可包括成骨因子以进一步促进装置10的部件与周围的骨骼和/或软组织之间的结合。此外，装置10可包括治疗剂，例如抗生素、类固醇、抗血栓剂、消炎药和/或止痛剂。在一个实施例中，生物活性剂可包含在装置上的覆层内。作为替换地或附加地，该装置可为多孔的并且生物活性剂可包含在装置的孔内。生物活性剂例如可以是用于调节软骨或骨头生长的骨形成蛋白/骨形态发生蛋白(BMP)。
本发明的侧向壁或支架36也可包括用于接纳骨紧固件以将支架36固定到棘突上的孔口50。这种紧固构件可确保支架36被平地和/或牢固地压靠在棘突上以避免支架36相对于该棘突的任何间隙。此外，当可植入装置20以这种方式紧固到棘突上时，该系统10可用作促进融合的装置。
所述孔口可包括一定范围内的尺寸和形状。例如，如图2C所示，孔口50可包括埋头孔52以便能将骨紧固件60更好地靠置在侧向壁36上。此外，如图2A所示，由于上部34的长度可以比下部32的长度短，所以下部和上部32、34的孔口50可沿纵向轴线错开。此特征允许沿脊柱叠置或植入多个可植入装置20。
现在转到图3，骨紧固件60可包括螺栓70，该螺栓包括头部72和带螺纹的长形体74。为了将螺栓70固定在孔口50中，设置有螺母80，该螺母具有头部82、体部84和带螺纹的内腔86，该内腔用于接纳螺栓70的带螺纹的长形体74。如图1所示，当螺母80被旋拧到螺栓70上时，侧向壁36可相互靠拢。这样，骨紧固件60和间隔体20可与棘突形成紧密、牢固的连接。在一些实施例中，间隔体20和相邻的棘突之间的紧密、牢固的连接将限制选定的脊椎水平处的运动，从而促进该水平处的融合。在其它实施例中，螺母80和螺栓70可被充分拧紧以便防止间隔体20在棘突之间移动错位，但也可留有足够的宽松度以允许间隔体20和棘突之间有少量间隙，从而不会促进融合或使融合较慢地发生。此外，如下面的图10所示，在一些实施例中，该系统10可包括两个骨紧固件60，使得下部和上部的侧向壁36都可牢牢地紧固于棘突。这样，可设想，装置20在定位于两个相邻椎骨的棘突之间时可固定到一个棘突上而不固定到另一个棘突上，或者可固定到两个相邻的棘突上。
图4A和图4B示出在植入期间用于组装骨紧固件60的插入工具100。该插入工具100可包括一对延伸到握持部分112的手柄110。握持部分112可包括诸如为凸起部分114的表面变型以便为使用者提供牢靠的握持表面。如本领域所公知，手柄110以类似于夹钳和剪刀的方式通过可枢转的铰链120相互连接。臂115从各手柄110的末端延伸，该臂115包括骨紧固件保持部分140A、140B。臂115通过可枢转的铰链连接部122连接于手柄110。可在手柄110之间设置板簧130以便朝张开的位置偏压保持部分140A、140B。
如在图5B和图5C中更详细地示出，骨紧固件保持部分140A可包括一腔体，该腔体构造成在植入过程中牢固地保持骨紧固件60的螺栓70的头部72，骨紧固件保持部分140B可包括第二腔体，该第二腔体构造成牢固地保持螺母80的头部82，如图8所示。此外，如图5C所示，该骨紧固件保持部分140B还可包括(齿轮)传动机构150。该传动机构150包括从骨紧固件保持部分140B延伸的端口160。端口160可包括构造成接纳如图6A和图6B所示的拧紧器具200的开孔162。如图7所示，拧紧器具200可包括在近侧延伸到握持部分204和在远侧延伸到末端206的轴202，该末端成形和构造成互补地配合在端口160的开孔162内。
如图9所示，为了组装系统10，可植入的装置20被插入到相邻椎骨的棘突之间。可使用任意适当的外科手术方法来使棘突暴露/可见。如图11A和图11B所示，在可植入装置20被适当地对准而使棘突被牢固地容纳在装置20的镫形件38内之后，可穿过所述一对侧向壁36中的每一个的孔口50打孔(所述孔口作为用于安设通过棘突的孔的引导)，并使得骨紧固件60可定位在该孔中并穿过棘突。可利用例如打孔器300形成所述孔。打孔器300可包括由板簧320和可枢转的铰链322连接的一对臂312。所述臂312在近侧延伸到握持部分314和在远侧延伸到夹爪316。从各夹爪316延伸有适于切穿骨的锋利的切刃318。
如图所示，锋利的切刃318可成形为类似筒形，与可植入装置的孔口50的直径匹配。锋利的切刃318可构造成在骨骼被切割时接纳并移除骨骼。例如，如图所示，筒形的锋利的切刃318可包括在骨骼被切割时接纳骨骼的中空的内部区域。由此被切除的骨骼被打孔器300保持，并可在形成孔之后被移除。为了确保没有剩余额外的骨材料残留，外科医生可选择按需要在一个或多个重复步骤中通过插入具有与所述孔直径相同的筒形末端的任何适当工具将被切出的孔清理干净。一旦所述孔被制成并被清理，便可将骨紧固件60插入穿过侧向壁36的孔口50。
为了将骨紧固件60固定到安设好的装置20上，可将骨紧固件60的螺栓70和螺母80分别安置到插入工具100的骨紧固件保持部分140A、140B中。然后，对插入工具100进行定位以将螺栓70和螺母80与装置20的孔口50对准。当已确定螺栓70和螺母80的角度和位置正确时，可将拧紧器具200安置到端口160中。旋转握持部分204使得传动机构150转动及螺母80转动，从而将螺母80旋拧到螺栓70上。
插入工具有利于螺栓70和螺母80的对准和旋拧。例如，由于壁36的侧面上的可用空间有限，外科医生难以将螺栓70和螺母80穿过棘突定位。插入工具100将螺栓70和螺母80保持在适当对准的位置以便确保它们在组装过程中易于旋拧到一起。此外，插入工具100和附带的拧紧器具200使得螺母80易于转动以便使部件相互固定。
应当理解，如图9和图10所示，拧紧器具200可在螺栓70和螺母80附接到插入工具100上之前或之后连接于插入工具100，且首先可将骨紧固件60旋拧通过间隔体20的上部34，然后可将附加的骨紧固件60旋拧通过下部32。此外，拧紧器具200使得使用者能够通过调节握持部分204的顺时针和/或逆时针转动的圈数来容易地控制期望的拧紧程度。
在一些实施例中，可设置一个或多个附加的器具以辅助定位待治疗椎骨的棘突。例如，为了在腰椎骨的棘突之间恰当地植入装置20，需要将患者定位成具有一定程度的脊柱前凸。但是，在外科手术过程中，患者可能未被理想地定位。因此，为了帮助外科医生来产生期望的脊柱前凸程度，如图12所示，可设置一把压缩钳350。
压缩钳350可包括两个末端夹持部分354、358。可推动夹持部分354、358穿过位于待治疗脊椎水平的棘突366、370的上方和下方的棘突间韧带。然后，可压拢夹持部分354、358以将棘突366、370朝向彼此推动以便装配到椎板间-棘突间装置20的镫形件38中。
一旦将装置20适当地定位，便可使用前述骨锚固件60和插入工具100将装置20固定于棘突366、370上。此外，为了在骨锚固件60的插入过程中有助于将棘突366、370保持在压缩位置，压缩钳350可包括锁定机构362。该锁定机构例如可包括设置在压缩钳手柄的近侧部分的棘齿系统。
在一些实施例中，插入工具100、拧紧器具200、打孔器300和压缩钳350可设置成与一个或多个装置20一起使用的器具组。因此，可将插入工具100和打孔器的尺寸和形状设定为使得利用打孔器300产生的孔可与由插入工具100保持的螺栓70和螺母80适当地对准。
通过利用骨紧固件60将可植入装置20牢固地固定到棘突上，可促进骨组织的融合。此外，如果需要，可在可植入装置20的中部30内放置附加的骨生长材料，例如骨移植物，以便加强骨骼的生长和融合。当然，应当理解，如前面所述，可在可植入装置20的表面上设置其它的促进生长的表面变型，例如孔隙或孔，以便实现这种向内生长。
此外，尽管装置20被描述为具有上部和下部的侧向壁36，但是装置20也可包括具有单对侧向壁36的U形植入物。例如，可在L5-S1脊椎水平处使用这种装置。例如，装置20可包括单对侧向壁36，该对侧向壁构造成与L5椎骨的棘突接合。此外，装置20可包括用于将下部32固定于骶骨的机构。如上所述，可利用骨锚固件60将上部的侧向壁固定于L5棘突，从而限制L5-S1水平处的运动并促进该水平处的融合。在2006年4月7日提交的共同待决的U.S.专利申请No.11/400,586中描述了用于将该装置20固定于骶骨的各种装置和机构，该专利申请的全部内容引用于此作为参考。
考虑到本说明书和在此公开的对本发明的实践，本发明的其它实施例对于本领域技术人员而言是显而易见的。本说明书和示例仅应被认为是示例性的，本发明的真正范围和精神由所附权利要求限定。

Claims (14)

1.一种脊柱稳定系统，包括：
可植入装置，该可植入装置具有U形的间隔体和一对侧向壁，所述间隔体构造成安置在椎骨之间并包括下部、上部、在所述下部和上部之间延伸的中部，所述一对侧向壁从所述下部和上部中的一个伸出以与椎骨的棘突接合，所述侧向壁的每一个都包括用于接纳骨紧固件的孔口；
骨紧固件，该骨紧固件包括螺栓和螺母以用于将所述可植入装置固定在所述棘突上；
插入工具，该插入工具使所述螺栓和螺母穿过所述侧向壁的孔口组装在一起，该插入工具包括第一臂、第二臂并构造成使所述螺栓和螺母在组装过程中相对于彼此保持对准，所述第一臂包括接纳所述螺栓的第一骨紧固件保持部分，所述第二臂包括接纳所述螺母的第二骨紧固件保持部分，所述插入工具还包括位于所述第二骨紧固件保持部分的内部的齿轮机构，其中所述齿轮机构的转动使得所述螺母转动；和
拧紧器具，该拧紧器具构造成与所述插入工具的所述齿轮机构协作以组装所述骨紧固件。
2.根据权利要求1所述的系统，其特征在于，所述中部是柔性的。
3.根据权利要求1所述的系统，其特征在于，所述间隔体包括有利于锚固在骨组织上的表面变型。
4.根据权利要求3所述的系统，其特征在于，所述表面变型包括齿、倒钩、凸缘、表面粗糙化或生物活性剂。
5.根据权利要求1所述的系统，其特征在于，所述间隔体还包括置于其中的骨移植材料。
6.根据权利要求1所述的系统，其特征在于，所述一对侧向壁中的一个侧向壁相对于所述一对侧向壁中的另一个侧向壁可动。
7.根据权利要求1所述的系统，其特征在于，所述螺栓和螺母是螺旋的。
8.根据权利要求1所述的系统，其特征在于，所述侧向壁的每个孔口都包括埋头孔。
9.根据权利要求1所述的系统，其特征在于，还包括从所述下部和上部中的另一个伸出的第二对侧向壁，并且还包括另一个骨紧固件，该另一个骨紧固件包括插入穿过所述第二对侧向壁的螺栓和螺母。
10.根据权利要求1所述的系统，其特征在于，所述拧紧器具可附装在所述插入工具的所述齿轮机构上并且使所述螺母相对于所述螺栓转动。
11.根据权利要求1所述的系统，其特征在于，所述拧紧器具的转动使所述螺栓和螺母旋拧在一起。
12.根据权利要求1所述的系统，其特征在于，还包括压缩钳，该压缩钳用于将棘突安置在所述一对侧向壁之间。
13.根据权利要求1所述的系统，其特征在于，还包括打孔器，该打孔器构造成穿过所述棘突的骨组织打孔以形成用于接纳所述骨紧固件的孔。
14.根据权利要求13所述的系统，其特征在于，所述打孔器将从所述棘突切除的骨组织移除以形成所述孔。
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TW200833292A (en) 2008-08-16
US8439951B2 (en) 2013-05-14
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US7922750B2 (en) 2011-04-12
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AU2007325094A1 (en) 2008-06-05
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US20080228225A1 (en) 2008-09-18
WO2008067452A1 (en) 2008-06-05
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