CN100594857C - 脊椎植入物和脊椎植入*** - Google Patents

脊椎植入物和脊椎植入*** Download PDF

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Publication number
CN100594857C
CN100594857C CN200580002566A CN200580002566A CN100594857C CN 100594857 C CN100594857 C CN 100594857C CN 200580002566 A CN200580002566 A CN 200580002566A CN 200580002566 A CN200580002566 A CN 200580002566A CN 100594857 C CN100594857 C CN 100594857C
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China
Prior art keywords
cleat assemblies
tubular body
end wall
vertebral
spinal implant
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Expired - Fee Related
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CN200580002566A
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CN1909857A (zh
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D·G·卡拉哈里奥斯
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Warsaw Orthopedic Inc
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Warsaw Orthopedic Inc
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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
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Abstract

一种脊椎植入物包括管状体(22)，其尺寸可配合在两脊椎终板之间，和一对环形楔子组件(24、26)。各楔子组件包括外端壁(40)、内端壁(42)、和限定空心通孔(38)的侧壁(34、36)。从各外端壁延伸一个或多个长钉，并且各空心通孔的尺寸可配合覆盖管状体的端部，和沿管状体长度的至少一部分从端部滑动通过。

Description

脊椎植入物和脊椎植入***
技术领域
本发明一般涉及一种替代一个或多个脊椎体及其邻近椎间盘的植入物，而更具体地涉及具有用于稳定组件的脊椎植入组件。
背景技术
由于外伤、疾病或先天性缺陷可产生各种脊髓损伤和残缺。这些损伤和疾病可以最终导致一个或多个脊椎体损坏，并导致脊椎切除，其中一个或多个损坏的脊椎体及其邻近的椎间盘被切除。脊椎切除以后的脊骨重建对于外科医生形成不小的挑战。
外科手术关心在剩余向头的和向尾的脊椎体之间***脊椎植入物，以便保证植入物能够抵御轴向、扭转和剪切负载而不致造成植入物和相关移植材料的向前移位(“出界”)或向后退出。企图尽量降低减少这些方法失败的现有脊椎植入物通常导致其它不良的后果，诸如器械脱落、移植材料或植入物下沉、移植材料移位或附近血管或软组织结构由于其较高外形设计而侵蚀。
因此，需要一种脊椎植入组件，它能够防止出界或退位而不致伤害附近的骨骼、血管或软组织结构并且也不致显著地延长或复杂化外科手术过程。
发明内容
为达到上述目的，根据本发明的一个方面，一种脊椎植入物，用于***在两脊椎终板之间，包括：管状体，其尺寸配合在两脊椎终板之间；一对环形楔子组件，各楔子组件包括外端壁、内端壁、和限定空心通孔的侧壁，其中从各外端壁延伸一个或多个长钉，并且其中各空心通孔的尺寸配合覆盖管状体的端部，并且直接沿轴向沿管状体长度的至少一部分从端部滑动通过，在两脊椎终板之间***管状体以前，管状体滑动穿过在各楔子组件中的空心通孔，并且其中在各外端壁上的长钉互相指向外面，并且延伸趋向管状体的相对端部而不延伸超过管状体的相对端部，所述脊椎植入物还包括用于固定管状体到楔子组件的固定组件，固定组件包括：延伸通过各楔子组件侧壁的一个或多个小孔；延伸通过一个或多个小孔之一而与管状体接触的固定部件。
此外，根据本发明的另一个方面，一种脊椎植入物，用于***两脊椎终板之间，包括：生物支撑件，其尺寸配合在两脊椎终板之间；一对环形楔子组件，各楔子组件包括外端壁、内端壁、和限定空心通孔的侧壁，其中从各外端壁延伸一个或多个长钉，和其中各空心通孔的尺寸配合覆盖生物支撑件的端部，并且被构造成直接沿轴向沿生物支撑件长度的至少一部分从端部滑动通过，其中在两脊椎终板之间***生物支撑件以前，生物支撑件滑动穿过在各楔子组件中的空心通孔，并且其中在各外端壁上的长钉互相指向外面，并且延伸趋向生物支撑件的相对端部而不延伸超过生物支撑件的相对端部，所述脊椎植入物还包括用于固定生物支撑件到楔子组件的固定组件，固定组件包括：延伸通过各楔子组件侧壁的一个或多个小孔；延伸通过一个或多个小孔之一而与生物支撑件接触的固定部件。
此外，根据本发明的再一个方面，一种脊椎植入***，用于***在两脊椎终板之间的可变空间中以便建立要求的脊椎对准，该植入***包括：具有第一对面端和第二对面端的管状体，该管状体的尺寸可跨接在脊椎终板之间的至少一部分上；第一楔子组件，包括第一带长钉的端壁，用于将第一楔子组件固定在脊椎终板之一上，和限定第一空心通孔的第一侧壁以便使第一对面端滑动地通过第一楔子组件；第二楔子组件，包括第二带长钉的端壁，用于将第二楔子组件固定在另一脊椎终板上，和限定第二空心通孔的第二侧壁，第二空心通孔的尺寸使第二对面端滑动地通过第二楔子组件，其中第一楔子组件可滑动地通过第一对面端，第二楔子组件可滑动地通过第二对面端，并且带长钉的第一端壁指向第一对面端，而带长钉的第二对端壁指向第二对面端，其中带长钉的诸端壁并不延伸到第一和第二对面端以外，所述脊椎植入***还包括一个固定***，用于在第一和第二楔子组件固定在脊椎终板上以后将第一和第二楔子组件固定到管状体上，固定***包括延伸通过各楔子组件侧壁的一个或多个小孔；延伸通过一个或多个小孔之一而与管状体接触的固定部件。
附图说明
图1为在脊柱内一个损坏脊椎体的立体图。
图2为按照本发明一个实施例的脊椎植入组件的分解图。
图3a为按照本发明第一实施例的楔子组件立体图。
图3b为按照本发明第二实施例的楔子组件立体图。
图4为在未接合位置中的脊椎植入组件立体图。
图5为设置在完整锥骨之间的脊椎植入组件立体图。
图6为包括设置在完整椎骨之间生物支撑件的脊椎植入组件立体图。
具体实施方式
为促进对于本发明的理解，现在将参考附图中阐明的实施例或例子，并且对其描述采取特定的语言。应该理解，本发明范围并不因此受到限制。对于所描述实施例的任何改变或进一步变型，和在此描述本发明原理的深入应用均认为是本行业有关熟练人士发生的正常行为。
首先参照图1，参考数字10涉及带有延伸在两个完整椎骨12b及12c之间的损坏椎骨12a的脊柱，并且椎间盘14a延伸在椎骨12a及12c之间。在典型的外科切除中，椎骨12a连同椎间盘14a及14b一起切除，从而在两椎骨12b及12c之间形成空缺。该过程可以利用本行业熟练人士所熟知的前方、前方侧面或其它方法实施。按照本发明实施例的脊椎植入组件然后用来充填在两完整椎骨12b及12c之间。虽然将要描述的实施例假定在除去单个椎骨的基础上，应该理解当外科手术需要时在本发明一个不同的实施例中，可以***在椎间盘空间中而不必除去椎骨。在还有另一个实施例中，本发明可以应用在除去两个或更多病态或损坏椎骨及其邻近椎间的脊椎盘切除手术以后的脊柱重建中。
现在参考图2，按照本发明一个实施例的脊椎植入组件一般用参考数字20表示，并包括连接在两个楔子组件24及26之间(其方式将在以下描述)的管状体22。管状体22限定中空的通孔28，其中可以配置接纳骨骼生成材料(未示)。为充分利用骨骼生成材料并在脊椎或椎间盘外科手术的后果中促进康复和骨骼复原，管状体22中可以设置多个开口30，以容许骨骼及组织向内生长和血管生长。管状体22可以设置成为各种长度或修整配合由于脊椎切除形成的空隙，以避免在植入后损坏邻近完整椎骨的较弱骨骼。
在一个实施例中，一种外科网孔管或“笼”(在本行业中是众所周知的)可以用来作为管状体22。这样笼子的例子披露在美国专利中。
在此综合属于Drewry等的5,897,336和6,149,651专利(即“Drewry专利”)作为参考。如在Drewry专利中所描述，管状体可包括斜角的、互相交叉的长形杆而形成多个三角形小孔。也如在Drewry专利中所描述，管状体可具有非圆形截面并且其形状成为更加密切配合邻近完整椎骨的外形。
楔子组件24包括具有外侧壁34和内侧壁36的环形件32，它们限定一个可以通过(例如利用滑动)管状体22的通孔38。内侧壁36可是光滑的，以促进管状体22滑动通过。环形件32还可以包括延伸在外侧壁34和内侧壁36之间的外端壁40和内端壁42，而外端壁40具有多个长钉44，其形状适合于穿过邻近的完整椎骨的终板，以在原处保持楔子组件24。
为在楔子组件内部和周围促进骨骼向内生长和形成血管，可以在外侧壁34和内侧壁36上设置一个或多个穿过的小孔46，并且与通孔38连通。在安装后，这些小孔46可以充填移植材料以加速康复过程。此外，为在安装后固定楔子组件在管状体24上，可以在件32的侧壁34和36上设置通过的螺纹小孔48，它们与通孔38连通，其中各小孔48适合于接纳固定机构50(例如，可以是平头机器螺丝)。
其它例子包括预先固定的销子、铆钉、和/或U形钉。
为安装方便，楔子组件24的内端壁42可以设置多个对准位置52，其形状用来配合在安装工具(未示)上的对应栓钉以便容许楔子组件24旋转和轴向移动。根据对准位置52沿内端壁42的位置，对准位置52可以配置成为内端壁42上的凹进区域或者延伸通过内端壁42并且与小孔46连通的开口。在另一可替代方案中，对准位置52可以从内端壁42向外突出以便与在安装工具(未示)上对应凹进区域配合。外端壁40可包括沟槽53或其它纹理以减少活动，并且当楔子组件已经嵌入邻近完整椎骨的端部以后，促进在楔子组件24之间获得牢固的接触面。
在可替代的方案中，楔子组件24的形状可以改变为广泛地适应病人不同的解剖构造和外科应用，而仍对于邻近完整的椎骨提供牢固和稳定的结合。为对应脊柱的宫颈、胸腔、或腰椎区域或者最密切地配合具体病人的解剖特征，部件32可以制造成为广泛不同的直径。还有，内侧壁36的尺寸可以容许管状体22(例如具有从13mm到25mm的预定直径)滑动地穿过部件32。虽然图2描述环形部件32为大体圆柱形，对于邻近完整的椎骨提供无干涉的对准，外侧壁34和/或内侧壁36的轮廓可以更密切地对应于邻近完整椎骨的形状，从而获得低矮的安装外形。
现在参照图3a，楔子组件24的外端壁40基本上平行地对准内端壁42。可替代地，如图3b所示，楔子组件24具有端壁40及42，它们互相成为斜角以便适应各种脊柱前凸和脊柱后凸角度。成角度的端壁可以提供牢固和稳定的安装，这样可密切地配合具体病人的对准要求。例如，楔子组件24可以具有4.8度或15度的脊柱前凸角度。
再参照图2，楔子组件26可包括一个或多个长钉54和一个或多个具有相应定位螺丝的螺纹小孔56。长钉54、小孔56和定位螺丝58可以与以上描述楔子组件24的长钉44、小孔48和定位螺丝50完全相同。楔子组件26的其它特征可与楔子组件24相同，因此将不予详细描述。不过应该指出，楔子组件24不一定与楔子组件26完全相同。例如，楔子组件24可以包括图3a所示基本平行的端壁，而楔子组件26与图3b所示的楔子组件24完全相同，包括互相成为角度的端壁。
管状体22和楔子组件24及26可以包括生物兼容的材料或由其形成。这样的材料在强度方面能够足够抵抗外部压力、轴向、扭转或弯曲负荷，并且其强度对于邻近完整椎骨提供足够支承。该器件可以完全由钛制成，不过其它生物兼容材料也可以使用，诸如外科级的不绣钢、诸如HEDROCEL&commat的多孔钛材料(由美国新泽西州的Implex Corporation of Allendale提供)，或射线透明的聚合物材料，诸如聚醚醚酮(PEEK)(由联合王国的Victrex PLC提供)。脊椎植入组件20的部件22、24和26可以用同样的材料形成，或者可替代地可以用不同但兼容的材料制成。
现在参照图4，图2的部件可以预先装配以便容许脊椎植入组件20植入脊柱中由于脊椎切除而形成的空缺。例如，一旦管状体22已经选定和/或修整而配合在完整椎骨之间的空隙中(如参照图1中所讨论)，楔子组件24可以放置在管状体22的端部上，其中长钉44延伸趋向管状体的端部。楔子组件26可以放置在管状体22的另一端，而长钉54延伸趋向管状体的另一端，其方向相反于长钉44。为在安装中不损坏邻近终板的较弱骨骼，楔子组件可以滑动地沿管状体定位，使长钉不突出在管状体端部以外。
管状体22然后可以充填适当的骨质生成材料(未示)，包括自体移植体、同种异体移植种体、异种移植体、去除矿物质的骨骼、合成和天然骨胳移植替代物，诸如生物陶瓷和聚合物，和骨质诱导因子。应该理解，骨质生成移植材料可以在脊椎植入组件20安装以前或安装中任何时候充填，并且甚至在安装以后通过管状体22中开口30***移植材料而进行充填。
现在参照图5，图4中的构造可以在外科手术中***由于椎骨12a(在图1中)的切除而形成的空缺，其中长钉44延伸趋向完整的椎骨12b和长钉54延伸趋向完整的椎骨12c。
楔子组件24及26可沿管状体22前进，并且趋向完整椎骨的终板，直到长钉嵌入终板为止。
根据外科手术的方法和手术的暴露程度，可以利用本行业中已知的一种或多种器件使楔子组件嵌入脊椎终板。在一个例子中，楔子组件可利用具有分叉或可变C-形头部的冲击器安装。该头部可以容纳各种直径的楔子组件。冲击器头部上的栓钉与楔子组件24的外端壁40中对准位置52配合以便旋转地和轴向地使楔子组件定位，并且握住楔子组件而同时用小锤打击冲击器，使长钉嵌入邻近脊椎终板。该过程可对于楔子组件26重复进行。
另一个可以用来安装楔子组件的器件是分隔器，该器件可***在两楔子组件之间而迫使其互相分开进入邻近脊椎终板。在楔子组件长钉利用(例如)分隔器或冲击器嵌入以后，分隔器也可以用来在向头的和向尾的完整椎骨之间建立要求的空缺，而使矢状平面的外科修复平衡。还有另一使楔子组件定位的器件是一种压缩器，它锚定在相对静止的结构上，可以用来将长钉拉入邻近椎骨的终板。这些器件或其它在行业中已知的器件可以单独使用或联合安装楔子组件并且在邻近椎骨之间建立要求的间隔距离。
在楔子组件24及26安装并且正确地间隔定位以后，固定机构50(在本例子中为定位螺丝)可以***楔子组件24的小孔48中并旋转，直到其至少一部分通过内侧壁36冒出为止。在某些实施例中，定位螺丝50可以预先固定。定位螺丝50还可以穿过管状体22的网孔以便将管状体22固定在楔子组件24上。可替代地，定位螺丝可以在管状体22表面上施加压力以将管状体22固定在楔子组件24上。楔子组件26可以用对于楔子组件24所描述的完全同样方式固定在管状体22上。在脊椎体更换组件20安装以后，附加的生物生长材料可以通过小孔充填在楔子组件24中以便促进骨骼康复和和生长。组件26同样可以充填生物成长材料。
与其它前侧稳定技术相比，安装脊椎植入组件20相对地比较简单并且相对需要植入其它硬件或准备榫眼的外科手术相比可以缩短手术时间。此外，脊椎植入组件20的安装可以补充而不是干涉其它植入稳定器件(诸如螺钉及板、螺钉及杆、和支撑螺钉***)。一旦安装以后，植入物20具有很低矮的外形，从而减少血管结构侵蚀的风险。
如以上安装的脊椎体更换组件20可以承受扭转、轴向和剪切负载，减少向前位移或向后退缩的风险，并且因此尽量减少病人发生神经缺陷。还有，这样的安装可以防止管状体下坐(“望远镜管式的伸缩”)或者生物支撑进入邻近脊椎终板的相对较弱骨骼，这通常在传统接榫技术中发生。防止发生下坐可能由于嵌入的长钉和端壁更宽的表面面积，即在邻近完整的椎骨端部较大的面积上分布负载。因为楔子组件并不处于管状体的空心通孔以内，而是固定在管状体以外，所披露的构造进一步提供一个优点，即容许位于管状体内部的生物成长材料和邻近椎骨终板之间增加接触，以便促进骨骼生长。
在某些应用中可能另一种安装方法是有利的，例如脊椎植入组件20的部件并不预先初步装配。楔子组件24及26的长钉44及54，在管状体22通过楔子组件24及26之间以前，各自被驱入完整的椎骨12b和12c中(图1)。管状体22然后可充填生物成长材料，并且滑动地定位在楔子组件24及26之间的空间中。定位螺丝50和58然后如以上所述进行安装。
现在参照图6，在另一可替代实施例中，管状体22可以用生物支撑移植材料60更换而形成脊椎植入组件62。
支撑件可以是同种异体或自体移植材料，而移植物可以取自腓骨、肱部、或其它任何本行业中已知的来源。在该实施例中，终板24及26放置在生物支撑移植物60上，其尺寸可配合在邻近完整椎骨终板之间。脊椎植入组件62然后可以按照对于脊椎植入组件20所描述的相似方法安装。
不过在该实施例中，定位螺丝50及58的形式可以使其用螺纹旋入生物支撑移植件56中。例如，尖头螺丝是合适的。
虽然以上只详细描述本发明几个示范性实施例，本行业熟练人士将立即理解在这些示范性方案中可以有许多变型而不致实质上偏离本发明的新颖原理和优点。相应地，所有这些变型均将包括在以下权利要求所限定的本发明范围以内。在权利要求中，手段和功能条款打算包括在此描述的结构作为实施所叙述的功能，并且不但包括结构上的相当者，还包括相当的结构。

Claims (16)

1.一种脊椎植入物，用于***在两脊椎终板之间，包括：
管状体，其尺寸配合在两脊椎终板之间；
一对环形楔子组件，各楔子组件包括外端壁、内端壁、和限定空心通孔的侧壁，
其中从各外端壁延伸一个或多个长钉，并且其中各空心通孔的尺寸配合覆盖管状体的端部，并且直接沿轴向沿管状体长度的至少一部分从端部滑动通过，在两脊椎终板之间***管状体以前，管状体滑动穿过在各楔子组件中的空心通孔，并且其中在各外端壁上的长钉互相指向外面，并且延伸趋向管状体的相对端部而不延伸超过管状体的相对端部，所述脊椎植入物还包括用于固定管状体到楔子组件的固定组件，固定组件包括：延伸通过各楔子组件侧壁的一个或多个小孔；延伸通过一个或多个小孔之一而与管状体接触的固定部件。
2.如权利要求1所述的脊椎植入物，其特征在于，一个或多个小孔具有螺纹并且固定部件为定位螺丝。
3.如权利要求1所述的脊椎植入物，其特征在于，一个或多个开口延伸通过各楔子组件的侧壁，开口的尺寸容许移植材料进入空心通孔。
4.如权利要求1所述的脊椎植入物，其特征在于，各楔子组件的内端壁具有一个或多个对准位置以便使楔子组件对准和定位。
5.如权利要求1所述的脊椎植入物，其特征在于，对于楔子组件中的至少一个，外端壁相对于内端壁形成角度。
6.如权利要求5所述的脊椎植入物，其特征在于，外端壁与内端壁之间的角度在4到15度之间。
7.如权利要求1所述的脊椎植入物，其特征在于，楔子组件的诸端壁具有沟槽。
8.如权利要求1所述的脊椎植入物，其特征在于，各楔子组件的空心通孔是光滑的。
9.如权利要求1所述的脊椎植入物，其特征在于，空心通孔的直径在13mm到25mm之间。
10.一种脊椎植入物，用于***两脊椎终板之间，包括：
生物支撑件，其尺寸配合在两脊椎终板之间；
一对环形楔子组件，各楔子组件包括外端壁、内端壁、和限定空心通孔的侧壁，其中从各外端壁延伸一个或多个长钉，和其中各空心通孔的尺寸配合覆盖生物支撑件的端部，并且被构造成直接沿轴向沿生物支撑件长度的至少一部分从端部滑动通过，其中在两脊椎终板之间***生物支撑件以前，生物支撑件滑动穿过在各楔子组件中的空心通孔，并且其中在各外端壁上的长钉互相指向外面，并且延伸趋向生物支撑件的相对端部而不延伸超过生物支撑件的相对端部，
所述脊椎植入物还包括用于固定生物支撑件到楔子组件的固定组件，固定组件包括：延伸通过各楔子组件侧壁的一个或多个小孔；延伸通过一个或多个小孔之一而与生物支撑件接触的固定部件。
11.如权利要求10所述的脊椎植入物，其特征在于，所述小孔带有螺纹，所述固定部件为延伸通过各小孔以便将生物支撑件固定在楔子组件上的定位螺丝。
12.如权利要求11所述的脊椎植入物，其特征在于，在分隔力分开楔子组件以后定位螺丝延伸通过各小孔以获得所要求的脊椎对准。
13.一种脊椎植入***，用于***在两脊椎终板之间的可变空间中以便建立要求的脊椎对准，该植入***包括：
具有第一对面端和第二对面端的管状体，该管状体的尺寸可跨接在脊椎终板之间的至少一部分上；
第一楔子组件，包括第一带长钉的端壁，用于将第一楔子组件固定在脊椎终板之一上，和限定第一空心通孔的第一侧壁以便使第一对面端滑动地通过第一楔子组件；
第二楔子组件，包括第二带长钉的端壁，用于将第二楔子组件固定在另一脊椎终板上，和限定第二空心通孔的第二侧壁，第二空心通孔的尺寸使第二对面端滑动地通过第二楔子组件，其中第一楔子组件可滑动地通过第一对面端，第二楔子组件可滑动地通过第二对面端，并且带长钉的第一端壁指向第一对面端，而带长钉的第二对端壁指向第二对面端，其中带长钉的诸端壁并不延伸到第一和第二对面端以外，
所述脊椎植入***还包括一个固定***，用于在第一和第二楔子组件固定在脊椎终板上以后将第一和第二楔子组件固定到管状体上，固定***包括延伸通过各楔子组件侧壁的一个或多个小孔；延伸通过一个或多个小孔之一而与管状体接触的固定部件。
14.如权利要求13所述的***，其特征在于，所述小孔带有螺纹，并且所述固定部件为可延伸通过各带螺纹小孔的定位螺丝。
15.如权利要求14所述的***，其特征在于，在分隔力改变脊椎终板之间的空间以后，定位螺丝延伸通过各带螺蚊的小孔，以建立要求的脊椎对准。
16.如权利要求13所述的***，其特征在于，尺寸容许移植材料进入第一空心通孔的一个或多个开口延伸通过第一侧壁。
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