CN105534621A - 肌间融合器、椎间盘假体、锚定装置及植入器械 - Google Patents
肌间融合器、椎间盘假体、锚定装置及植入器械 Download PDFInfo
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- CN105534621A CN105534621A CN201510994246.XA CN201510994246A CN105534621A CN 105534621 A CN105534621 A CN 105534621A CN 201510994246 A CN201510994246 A CN 201510994246A CN 105534621 A CN105534621 A CN 105534621A
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- Prior art keywords
- anchoring device
- fusion device
- vertebra
- prosthese
- fusion
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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- 238000000034 method Methods 0.000 abstract description 12
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- 230000004048 modification Effects 0.000 description 31
- 238000003780 insertion Methods 0.000 description 16
- 230000037431 insertion Effects 0.000 description 16
- 208000007623 Lordosis Diseases 0.000 description 14
- 230000033001 locomotion Effects 0.000 description 13
- 238000013461 design Methods 0.000 description 11
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- 208000037873 arthrodesis Diseases 0.000 description 2
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Landscapes
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
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Abstract
提供肌间融合器、椎间盘假体、锚定装置和植入所提供的融合器或假体以及锚定装置的器械,以及在椎骨中植入脊椎植入物和锚定装置的***和方法。肌间融合器或椎间盘假体紧密配合到锚定装置(1),该锚定装置包括沿纵轴线呈弧形且在纵轴线上是细长形的本体(10),其尺寸和曲率半径以这种方式被设计,即通过使其纵轴线基本沿椎间空间的平面而将锚定装置(1)植入到椎骨的椎板中,在椎间空间内利用器械将锚定装置(1)***以通过位于融合器(2A、2B)的至少一个***壁内或椎间盘假体(2C)的至少一个板上的沟槽,以便穿到至少一个椎板内。
Description
本申请是申请日为2008年6月9日、发明名称为“肌间融合器、椎间盘假体、锚定装置及植入器械”的中国专利申请200880025422.7(PCT/IB2008/001484)的分案申请。
技术领域
本发明涉及整形外科植入物领域,并且更加确切地涉及脊椎植入物领域,例如椎间盘假体和肌间融合器(intersomaticcage)。椎间盘假体被植入两块邻近的椎骨之间以便维持或恢复椎骨间的间隙同时也可保持良好的可动性。肌间融合器被植入两块邻近的椎骨之间以允许在盘间隙中的骨组织移植物(或替代物)的***和生长,以便实现关节固定(两个椎骨的融合)。当***融合器后,椎骨的间隙可用自适应松质骨或适当的骨质替代物充满。特别地,此外,本发明涉及用于椎间融合移植术的椎间盘假体和肌间融合器,并且更加确切地涉及通过骨的锚定装置将其精确附连到椎骨以及用植入器械将其精确植入到盘空间内。
背景技术
本领域的一个问题涉及在椎间盘假体或肌间融合器被植入盘间隙中后,在肌间融合器的情况下至少在融合器任一侧的移植物生长和在肌间融合器与椎骨融合之前,椎间盘假体或肌间融合器在盘间隙中的稳定性。更一般地,这个问题涉及脊椎植入物(融合器或假体)在椎骨上的固定。例如存在的风险是假体或融合器在当病人活动时施加在其上的应力作用下或是植入物将不能继续牢固固定到椎骨时将在椎骨间隙内活动。因此脊椎植入物(假体或融合器)必须不但有阻止其枢转转动的外形而且必须有阻止其在椎骨间隙内或相对于椎骨活动的装置。
从以前的设计,我们知道的解决方法包括用槽口装备假体或融合器的上表面和下表面来防止运动。但是,这种解决办法并不完美并且假体或融合器仍能活动。从以前的设计,我们熟悉的方法还包括用骨质锚定装置装备假体或融合器,该骨质锚定装置被用来牢固地将假体或融合器附连到在其间植入假体或融合器的椎骨的椎板。这种类型的骨质锚定装置证明能有效固定假体或融合器。但是这种方法在植入过程中存在问题。
由于涉及到的尺寸的原因,而且特别是由于在椎骨间隙边缘存在血管和神经,所以通常非常难以进入椎骨间隙或椎骨间隙的边缘(或周围区域)。骨质锚定装置必须穿透椎骨到达足够的深度来牢固固定该装置。因此,这些骨质锚定装置通常沿着与椎骨间隙的平面几乎垂直的接近轴线或至少在相对于椎骨间隙的平面的基本斜轴线上的接近轴线被植入。其他类型的骨质锚定装置装配到与脊柱轴线基本平行并且在椎骨的一个面上延伸假体或融合器的板上。因此这些不同类型的装置需要外科医生实施较大的切口,对病人将会诱发损伤及相当大的风险。此外,这种类型的骨质锚定装置不易植入,因为其需要在椎骨间隙的边缘有足够的空间来允许该装置的植入,不幸地,根据所讨论的椎骨的不同,并非总是这种情况。而且,根据骨质锚定装置,如螺钉,在椎骨间隙周围必须清理出很大的间隙以便允许用于固定骨质锚定装置的器械通过。此外,一些骨质锚定装置必须距椎骨间隙在一定距离处且通常沿着与椎骨间隙的平面基本平行的接近轴线被螺钉固定或被压到椎骨内并且它们需要在椎骨间隙的边缘清理出较大的区域。
在本文中,提供脊椎植入物的锚定装置(以下简单地作为“装置”被引用)是有用的,例如肌间融合器或椎间盘假体,其在椎骨间隙的边缘不必具有比植入物本身的植入所需的间隙更大的间隙。因此希望骨质锚定装置尽可能最小地侵害其植入。
本发明的一些实施例的目标是通过提供一种锚定装置来克服以前设计的某些缺陷,该锚定装置被牢固地并且在椎板内的足够深度处植入以保持脊椎植入物倚靠这些椎骨的锚定装置,同时尽可能小地侵害它的植入。例如,该装置的植入可以在基本沿着椎骨间隙的平面或形成斜轴线(特别地如果是在该椎骨间隙的边缘被植入)的接近轴线上,但不需要在椎骨间隙周围清理出更大空间。
此目标的许多或所有方面可通过在至少一块椎骨内锚定脊椎植入物的一种锚定装置来实现,该锚定装置包括沿纵轴线在穿透端(penetrationend)和对接端(abutmentend)之间延伸的细长形本体,其特征是该本体具有沿着纵轴线勾勒的弧形外形,该弧形的尺寸和曲率半径以这种方式被设计,即通过没有变形地***通过位于脊椎植入物上且穿过至少一部分植入物的至少一个孔或托盘而可以将所述锚定装置植入到椎骨的表面内,该孔或托盘的形状、尺寸和取向被设置成允许锚定装置虽然其有弯曲但没有变形的通路,因此锚定装置穿透至少一块椎骨的表面并且在该椎骨的表面上或沿着该椎骨的表面牢固固定脊柱植入物。
根据一些实施例的另一个特征,所述本体所勾勒的圆弧的尺寸和曲率半径被设计成使得锚定装置可在与脊柱的垂直轴线成近似90°角度的接近轴线(approachaxis)上被植入到椎板中。
根据一些实施例的另一个特征,所述弧形且细长的本体包括至少一个弧形板。
根据一些实施例的另一个特征,所述穿透端包括倒角或斜角以便有利于所述装置穿入椎骨内。
根据一些实施例的另一个特征,所述本体装备有槽口,该槽口被定向成阻止所述装置被植入椎骨后的后撤。
根据一些实施例的另一个特征,所述本体的对接端包括至少一个止动元件,该至少一个止动元件用来与装置要固定的融合器或假体的至少一个表面相配合。
根据一些实施例的另一个特征,所述止动元件包括在锚定装置的至少一个面上的凸耳。
根据一些实施例的另一个特征,所述止动元件包括在本体侧面上的两个凸耳。
根据一些实施例的另一个特征,所述本体包括在其至少一个侧面上的弹性凸耳,该弹性凸耳面向对接端并且形成了阻止锚定装置后撤的止动元件。
本发明的一些实施例的目标是通过提供无需在椎骨间隙周围清理太大的空间就能轻易植入的肌间融合器来克服一些以前设计的某些缺点。
这个目标的多个或所有方面能通过一种肌间融合器实现,该肌间融合器包括形成用来接受骨组织移植或替代物的腔的壁,其特征是***壁包括横穿融合器的至少一部分的至少一个孔,该孔的形状、尺寸及取向与根据本发明的一个实施例所述的锚定装置的尺寸及曲率半径相适合,以便允许该锚定装置尽管有曲率但没有变形地通过该孔,从而将锚定装置定向成沿其间要植入融合器的椎骨中的一块椎骨的椎骨表面的方向,该锚定装置的尺寸和曲率半径被设计成使得该锚定装置可通过被***孔而被植入到椎骨表面内。
根据一些实施例的另一个特征,在所述壁的***表面,所述孔包括用来与锚定装置的至少一个止动元件相配合的至少一个止动元件表面。
根据一些实施例的另一个特征,所述止动元件表面包括被设置在孔的任一侧上的两个凹口,且所述凹口用来容纳在所述锚定装置的本体的侧面上的两个突出凸耳。
根据一些实施例的另一个特征,所述止动元件表面包括适于容纳在所述锚定装置的本体的至少一面上的突出凸耳的壁的***表面。
根据一些实施例的另一个特征,在所述壁的下表面或上表面,所述孔包括至少一个止动元件表面,该至少一个止动元件表面用来与所述锚定装置的至少一个弹性凸耳相配合、面向其对接端,这样的止动可阻止锚定装置从孔中后撤。
根据一些实施例的另一个特征,所述***壁包括用来与用于植入融合器的器械的抓握端相配合的至少一个附连设备。
根据一些实施例的另一个特征,所述壁的上表面和下表面中的至少一个表面包括防止融合器在其要被植入其间的椎骨之间运动的槽口。
根据一些实施例的另一个特征,通过融合器的上表面和下表面的参考平面(meanplane)形成了角度,该角度在融合器要被植入其间的椎骨上施加了脊柱前凸。
根据一些实施例的另一个特征,通过融合器的上表面和下表面的参考平面是大致相互平行的。
根据一些实施例的另一个特征,所述***壁包括两个孔,其每个孔面向上表面和下表面中的一个表面,从而允许锚定装置被锚定到在其间要植入融合器的椎骨中的每个椎骨内。
根据一些实施例的另一个特征,所述***壁包括彼此相依/横靠(alongside)设置的至少两个孔,每个孔限定了在融合器内锚定装置的一个可能的***轴线并且间接地限定了椎骨之间的融合器的一个可能的***轴线。
根据一些实施例的另一个特征,所述***壁包括在其上表面和下表面中的至少一个表面的至少一个***部分上的至少一个倒角,从而便于在椎骨之间***融合器。
本发明的一些实施例的目标是通过提供在椎骨间隙周围不需清理太大的空间就能轻易植入的椎间盘假体来克服一些以前设计的某些缺陷。
该目标的多个或所有方面能通过包括至少第一个板和第二板的椎间盘假体实现,该第一板和第二板利用至少一个弧形表面被相互铰接在一起,所述椎间盘假体的特征是至少一个板包括横穿至少一个板的至少一部分的至少一个孔,该孔的形状、尺寸和取向与根据本发明的一个实施例所述的锚定装置的尺寸和曲率半径相适应,以便允许该锚定装置尽管其有曲率但没有变形地通过该孔,从而将锚定装置定向成沿在其间要植入假体的椎骨中的一块椎骨的椎骨表面的方向,该锚定装置的尺寸和曲率半径被设计成使得该锚定装置可通过被***通过孔而被植入到椎骨表面内。
根据一些实施例的另一个特征,在板的***表面,所述孔包括用来与所述锚定装置的至少一个止动元件相配合的至少一个止动元件表面。
根据一些实施例的另一个特征,所述止动元件表面包括位于所述孔的任一侧上的两个凹槽,且该凹槽用来容纳在所述锚定装置的本体的侧面上的两个突出凸耳。
根据一些实施例的另一个特征,所述止动元件表面包括板的***表面,该板的***表面用来容纳在所述锚定装置的本体的至少一面上的突出凸耳。
根据一些实施例的另一个特征,在所述板的下表面或上表面,所述孔包括至少一个止动元件表面,该至少一个止动元件表面用来与所述锚定装置的至少一个弹性凸耳相配合、面向其对接端,这样的设置限制了所述锚定装置从孔中后撤。
根据一些实施例的另一个特征,至少一个所述板包括用来与植入假体的器械的抓握端相配合的至少一个附连设备。
根据一些实施例的另一个特征,至少一个所述板的上表面和下表面中的至少一个表面包括防止假体在其植入其间的椎骨之间运动的槽口。
根据一些实施例的另一个特征,穿过假体的至少一个板的上表面和下表面的中间平面形成了角度,该角度在假体要被植入其间的椎骨上施加了脊柱前凸。
根据一些实施例的另一个特征,穿过假体的至少一个板的上表面和下表面的中间平面是大致相互平行的。
根据一些实施例的另一个特征,每个板包括孔,每个孔面向上表面和下表面中的一个表面,从而允许通过将锚定装置锚定在假体要被植入其间的椎骨中的每一个椎骨内来将每个板固定。
根据一些实施例的另一个特征,所述假体包括具有几乎是平面的表面的可移动核芯,该核芯装配到一个板的几乎是平面的表面上和与另一个板的弧形表面互补的弧形表面上。
根据一些实施例的另一个特征,所述核芯包括与至少一个板上的设备互补的配合设备,从而限制核芯相对于该板的旋转移动和/或线性移动。
本发明的一些实施例的目标是通过提供在椎骨之间植入脊椎植入物(肌间融合器或椎间盘假体)和/或在这些椎骨中的至少一个椎骨中植入锚定装置的器械来克服一些以前设计的某些缺陷。该目标的多个或全部方面能通过在两块邻近的椎骨间植入脊椎植入物和在这些椎骨中的至少一个椎骨中植入锚定装置的器械来实现,这种器械首先包括至少一个具有头部的撞针(impactor),该头部的形状和尺寸被设计来推动锚定装置,并且所述器械其次包括沿纵轴线在第一端和第二端之间延伸的至少一个细长形的导杆,所述第一端被称为融合器或假体的抓握端,所述第二端被称为推动端,其中该抓握端包括用来与附连脊椎植入物的设备相配合的至少一个抓握设备,其特征是该导杆包括头部,其形状和尺寸被设计来至少部分地容纳撞针的头部并且其包括具有与根据本发明的一个实施例所述的锚定装置的曲率半径基本相同的曲率半径的至少一个引导表面,以便引导该锚定装置通过包括根据本发明的一个实施例所述的肌间融合器或根据本发明的一个实施例所述的椎间盘假体的脊椎植入物的孔,用于使锚定装置进入脊椎要被植入物植入其间的椎骨中的一个椎骨的椎骨表面内。
根据一些实施例的另一个特征,所述导杆的头部包括腔体,该腔体的形状和尺寸被设计来接纳所述锚定装置及至少部分地接纳撞针的头部,所述导引表面包括至少两个弧形沟槽,弧形沟槽各位于该腔体的一个侧面上以便在其本体的两个侧面上引导锚定装置,同时撞针的头部从这些沟槽的一端到另一端穿到该腔体内。
根据一些实施例的另一个特征,所述撞针包括杆,当利用把手操作该杆时,该杆相对于所述导杆滑动。
根据一些实施例的另一个特征,所述撞针包括至少一个止动元件,该止动元件限制了撞针头部在导杆头部内的穿透。
根据一些实施例的另一个特征,所述抓握设备在抓握端伸出到导杆的头部之外,以便允许抓握融合器或假体,这种抓握是通过使得引导表面的一端开口在融合器或假体内的孔上从而被支持且引导表面的另一端保持可***锚定装置而实现的。
根据一些实施例的另一个特征,所述附连设备是凹槽并且所述抓握设备是杆的一端,当用把手操作该杆时,该杆在导杆本体内滑动从而进入和离开融合器或假体的凹槽。
根据一些实施例的另一个特征,所述杆包括装配到凹槽中的螺纹孔上的螺纹端,从而当用把手操作该杆时可确保融合器或假体固定。
根据一些实施例的另一个特征,所述附连设备是凹槽并且所述抓握设备是弯曲杆的一端,称为压舌板,该压舌板的曲率半径与其***壁被勾勒成圆弧的融合器的曲率半径几乎相同,同时凹槽被设置在返回部件(returnpart)上,该返回部件在由壁所勾勒的圆弧构成的部件的圆心方向延伸由融合器的壁所勾勒的圆弧的一端,并且压舌板紧密装配到在该返回部件和由融合器的壁勾勒的圆弧的另一端之间的融合器的外形轮廓上,第二抓握设备设置在该另一端。
根据一些实施例的另一个特征,所述第二抓握设备被设置在压舌板的基座上,但在与支撑压舌板相对的一侧上,并且其包括用来容纳安装在导杆的杆上的插销的第二凹槽,其中当用把手操作该杆时,该杆在插销***第二凹槽内的至少一个位置和插销从第二凹槽取出并且因此释放融合器的位置之间枢转。
根据一些实施例的另一个特征,所述导杆的头部几乎沿融合器所勾勒的圆弧的曲率半径呈弧形或弯曲的。
根据一些实施例的另一个特征,所述撞针的头部的外形轮廓几乎是弧形或弯曲的以便赋予该轮廓与其在导杆头部内的通道相符合的曲率半径,其中撞针的头部被安装到允许其枢转的旋转轴线上从而可经过在导杆头部处的弧形处或弯曲处。
本发明的一些实施例的目标是通过提供在椎骨间脊椎植入物的植入***来克服一些以前设计的某些缺陷。该目标的多个或全部方面能通过在两个邻近的椎骨间脊椎植入物的植入***实现,该***包括至少一个脊椎植入物和在至少一块椎骨中锚定植入物的至少一个锚定装置,其特征是:
—脊椎植入物包括根据本发明的一个实施例所述的肌间融合器或根据本发明的一个实施例所述的椎间盘假体;以及
—锚定装置包括根据本发明的一个实施例所述的锚定装置。
根据一些实施例的另一个特征,所述***包括根据本发明的一个实施例所述的器械。
本发明的一些实施例的目标是通过提供在椎骨之间脊椎植入物(肌间融合器或椎间盘假体)的植入方法来克服一些以前设计的某些缺点。
本目标的多个或全部方面能通过***脊椎植入物的方法实现,其包括:
—提供根据本发明的锚定装置;
—提供脊椎植入物,该脊椎植入物包括根据本发明的一个实施例所述的肌间融合器或根据本发明的一个实施例所述的椎间盘假体;
—提供根据本发明实施例的植入器械;
—用植入器械的抓握装置来抓握脊椎植入物;
—在脊柱的邻近椎骨之间的椎骨间隙中***脊椎植入物;
—通过使得锚定装置的纵轴线沿着接近轴线来放置锚定装置,其中该接近轴线基本上沿着椎骨间隙的平面;
—使用植入器械的撞针,***锚定装置使其通过植入器械的导杆头部和植入物中的孔,同时锚定装置横穿植入物的至少一部分;以及
—使用植入器械的撞针,在邻近的椎骨中的一个椎骨中植入锚定装置的穿透端。
附图说明
在阅读下面描述并且参考附图,本发明各个实施例的其他特征和优点将变得更清楚,其中:
-图1A表示根据本发明的一个实施例所述的锚定装置的透视图,图1B表示根据本发明的另一个实施例所述的锚定装置的俯视图,以及图1C和图1D表示根据本发明的两个不同的实施例所述的锚定装置的侧视图;
-图2A、图2B和图2D分别表示根据本发明的实施例所述的肌间融合器的透视图、俯视图和轮廓图,图2C表示沿图2B所示的剖面2C-2C上该肌间融合器的剖视图及图2E表示沿图2D所示的剖面2E-2E上该肌间融合器的剖视图;
-图3A和图3B分别表示根据本发明的一个实施例所述的肌间融合器的前透视图和俯视图,图3C表示沿着图3B所示的剖面3C-3C的该肌间融合器的剖视图及图3D表示沿着图3B所示的剖面3D-3D的该肌间融合器的剖视图;
-图4A和图4B分别表示根据本发明的一个实施例所述的肌间融合器的前透视图和俯视图,图4C表示沿着图4B所示的剖面4C-4C的该肌间融合器的剖视图,以及图4D表示沿着图4B所示的剖面4D-4D的该肌间融合器的剖视图;
-图5A和图5B分别表示根据本发明的一个实施例所述的锚定装置植入导杆的头部的透视图和前视图,图5C和图5D分别表示根据本发明的一个实施例所述的锚定装置的引导元件的透视图和侧视图以及图5E表示用根据本发明的一个实施例所述的两个引导元件装备的导杆头部的前视图;
-图6A表示根据本发明的一个实施例所述的植入导杆和撞针的透视图,图6B、图6C和图6D分别表示根据本发明的一个实施例所述的植入导杆的俯视图、沿着图6B所示剖面6C-6C的植入导杆的剖试图和沿着图6C所示剖面6D-6D的植入导杆的剖视图,以及图6E表示根据本发明的一个实施例所述的撞针的侧视图;
-图7A和图7C分别表示即将被嵌入和已被嵌入的植入导杆、撞针、融合器及锚定装置的根据本发明的一个实施例所述的组装装置的俯视图,图7B和图7D分别表示沿着图7A所示的剖面7B-7B和沿着图7C所示的剖面7D-7D的该组装装置的剖视图;
-图8A和图8B分别表示用根据本发明的一个实施例所述的锚定装置装备的肌间融合器的透视图以及图8C表示装有根据本发明的一个实施例所述的肌间融合器的植入导杆一端的透视图;
-图9A和图9B分别表示装有用根据本发明的一个实施例所述的锚定装置装备的肌间融合器的植入导杆一端的透视图和俯视图以及图9C表示图9B所示的剖面9C-9C的剖视图;
-图10A、图10B和图10C分别表示支撑的肌间融合器的一个实施例的透视图、俯视图和沿图10B的轴线10C-10C的剖视图以及图10D、图10E和图10F分别表示支撑的肌间融合器的另一个实施例的透视图、俯视图和沿着图10E的轴线10F-10F的剖示图;
-图11A和图11B分别表示用锚定装置装备的椎间盘假体的一个实施例的透视图和侧视图,以及图11C和图11D分别表示用锚定装置装备的椎间盘假体的另一个实施例的透视图和侧视图。
具体实施方式
此外,本发明涉及锚定装置(1),该锚定装置是大致弧形并且用于脊椎植入物例如脊椎融合器(2A、2B)或椎间盘假体(2C)。在各种实施例中,所述锚定装置(1)可以是刚性的并且与设置在其固定的融合器(2A、2B)或假体(2C)上的孔或槽(20)配合。一般地,该孔或槽能被调整为沟槽来接纳锚定装置(1),但是本领域的技术人员将会意识到本发明为所述的锚定装置和所述的孔或槽(本文用其延伸含义)提供了多种形状并且意识到本文所用的术语“孔”、“槽”以及“沟槽”不应该被看作限制本发明的范围。此外,本发明还涉及脊椎融合器(2A、2B)和椎间盘假体(2C),在各种实施例中其可能有适于接纳锚定装置(1)的沟槽(20)或其他孔或槽。此外,本发明还涉及植入脊椎融合器(2A、2B)或椎间盘假体(2C)的器械和植入锚定装置来牢固固定融合器(2A、2B)或椎间盘假体(2C)的器械。在各种实施例中,所述器械是为锚定装置(1)而设计的以便在椎骨中固定该锚定装置并且还固定肌间融合器(2A、2B)或椎间盘假体(2C),该肌间融合器(2A、2B)或椎间盘假体(2C)包括保持或附连植入器械的至少一个构件(24),以便允许这些构件通过该器械被抓握或啮合。该附连装置(attachmentdevice)可以包括可容纳该器械的至少一个抓握装置(321)的至少一个凹槽(24),如图所示且下面将详细描述。但是,这个附连设备(24)还可包括在融合器或假体的外部上凸出的部分并且该部分被***到抓握设备(未示出)的凹槽内。另外,在某些实施变型中,这个附连设备(24)可至少部分地由融合器(2A、2B)或椎间盘假体(2C)的不同表面构成,该器械的抓握设备(321)于是具有与这些表面互补的外形轮廓以便允许抓握融合器或假体。
各种实施例允许该装置和相关器械尺寸的减小,从而允许在基本上是沿着椎骨间隙(盘间隙)的平面的接近轴线上植入锚定装置。如下所述即使当锚定装置试图沿着斜轴线植入,尺寸的减小也是特别有利的。本发明的各种实施例通过用在脊椎植入物(2A、2B、2C)中横穿该植入物至少一部分的孔(20)轻松植入锚定装置(1),且该锚定装置的尺寸和曲率半径以这种方式被设计,即该锚定装置(1)通过无变形地被***通过孔(20)而被植入到椎骨表面内,该孔(20)的形状、尺寸和取向被设置成允许锚定装置(1)尽管其有弯曲但没有变形地通过,因此该锚定装置(1)穿到至少一块椎骨表面内并且在这个椎骨表面上固定脊椎植入物。因此,本发明的这些实施例使用具有弧形本体的锚定装置,该弧形本体适于自由穿过其试图固定的脊椎植入物的接纳孔。因此,弧形锚定装置尽管其有弧形轮廓但没有变形地自由通过所述孔,有利于其植入到椎骨中。因此,在各种实施例中锚定装置可以是基本刚性的。
锚定装置(1)还可包括沿纵轴线在第一端和第二端之间延伸的细长形本体(10)。在本描述中,第一端称为穿透端且第二端称为对接端。各种实施例的锚定装置(1)的本体(10)可有弧形轮廓,该轮廓沿着纵轴线勾勒成弧形,例如圆弧或椭圆弧,其尺寸和曲率半径(或半径)以如下方式被设计,即锚定装置(1)通过使得装置(1)的纵轴线近似沿着椎骨间隙的平面而被植入到椎骨的椎板内。各种实施变型具有的锚定装置(1)可具有不同的曲率半径(或半径)。该装置在本体(10)的不同部分上还可具有多种不同的曲率半径,或可具有沿本体(10)变化的曲率半径。因此,该本体可有,例如圆弧或椭圆弧的外形轮廓,但是也可勾勒成更复杂的曲线,例如是具有相同曲率半径或不同曲率半径的多个圆弧首尾连接在一起或者是具有相同曲率半径或不同曲率半径的多个椭圆弧首尾连接在一起,甚至是其的任意组合,甚至是沿主体的位置的函数的曲率半径。在本描述中,术语“弧”、“圆弧”以及“曲率半径”对应于所有这些可能性。
因此,本发明的一些实施例提供了与锚定装置(1)的曲率半径(或半径)相关的不同的实施变型。例如,根据该装置(1)及特别是在其间植入融合器或假体的椎骨的装置的使用,该装置(1)优选地可具有在各种间隙中较大或较小尺寸的曲率半径。例如,根据预期用途该半径可能大小不一。根据锚定装置(1)的曲率半径,分别通过该装置(1)的穿透端和对接端的轴线形成角度(AC),特别地在图1C和图1D中可以看出。虽然该角度(AC)通常将会在90°到180°的范围内,但其也可选择小于90°的角度。该角度(AC)优选是处在110°和160°之间,在许多情况下在该角度范围内比超出这个范围能更有利于该设备的植入。根据期望的固定设置,角度(AC)的选择可以几乎是开放的。例如,如果想要通过使其牢固地紧贴靠椎板来固定该融合器或假体,则角度(AC)能在120°到180°的范围内选择,而如果相反想要固定融合器或假体以便防止其在椎间盘间隙的平面内的运动,则角度(AC)能在90°到150°之间选择。不同的实施变型可为锚定装置(1)提供不同角度来固定融合器或假体。例如在一个优选实施例中,角度(AC)可有例如接近135°的相互适合值,来通过使融合器或假体紧贴靠紧椎板以固定该装置并且阻止融合器或假体在椎间盘间隙的平面内的运动。
另外,根据融合器或假体的实施例,不管是自然脊柱前凸或病理性脊柱前凸(pathologicallordosis)或由假体所造成的前凸,该装置均可以选择不同的角度,主要是促进牢固安装。锚定装置(1)可被***通过沟槽(20),该沟槽设置在融合器(2A、2B)的至少一个***壁上或椎间盘假体(2C)的至少一个板上,并且横穿该融合器(2A、2B)或假体(2C)的至少一部分。该沟槽(20)可从融合器(2A、2B)的壁(25)的***表面或从假体(2C)的板的***表面延伸到该融合器(2A、2B)或该板的上表面或下表面,且具有为锚定装置(1)曲率半径设计的取向,从而在其间植入融合器(2A、2B)或假体的椎骨中的一块椎骨的椎板方向上定向该锚定装置。利用沟槽(20)的这个取向,锚定装置(1)可穿到至少一个椎板内并且紧靠该椎板固定融合器(2A、2B)或假体(2C)。取决于锚定装置(1)的曲率半径和角度(AC),根据不同的实施例,沟槽(20)的厚度和方向可不同。
因此本发明的一些实施例提供了肌间融合器(2A、2B),该肌间融合器包括形成接纳骨组织移植物或替代物的腔体(23)的***壁(25)。如图所示,这样的融合器可包括在其中心由其壁(25)形成的腔体(23),但是在其他实施变型中,该融合器还可由在其内部没有腔体的机体(block)组成,例如从以前的设计可知这样的融合器至少是成对使用以便在融合器之间形成腔体。在图10A所表示的实施变型中,肌间融合器(2A)包括从一侧到另一侧横穿其腔体(23)的支架(27)(brace),该支架(27)可被配置来加固融合器(2A)的壁(25)。这个支架(27)可具有不同的形式和取向,并且例如可被定向成在椎骨之间沿着融合器(2A)的***轴线。在各种实施例中,支架(27)可有小于融合器其余部分的高度。支架(27)相对于融合器其余部分具有的较小高度可允许融合器环抱具有任何不规则外形轮廓的椎板。因此,例如如图10A到图10C所述,支架(27)的上表面和下表面分别位于比融合器(2A)的上表面和下表面较低和较高的位置。因此,如果两块邻近椎骨的椎板具有***物,则融合器将遵循这些板的外形并且通常提供了更好的稳定性。在图10A到图10C所示的这个实施方式中,支架没有槽口因为其将不会与椎板相接触。但是,例如即使在这种情况下,该支架(27)仍可具有槽口(22),以便当骨质移植物已经围绕融合器生长时可增加融合器的稳定性。在图10D到图10F的实施方式中,支架(27)的下表面与融合器(2A)其余部分的下表面位于同一水平面上,而支架(27)的上表面位于比融合器(2A)其余部分的上表面较低的位置,具体地如图10E可以看出。在这个实施方式中,支架(27)的下表面装备有槽口(22)且在融合器的其余部分也具有槽口从而可限制融合器的运动。在一个变型中,这个支架可能不包括槽口。在一个变型中,这种类型的融合器还可被用在相对于该示例的相反的构型(inverseconfiguration)中。因此,在这个变型中,支架(27)将具有与融合器其余部分的上表面在同一水平面上的上表面和位于比融合器其余部分较高的下表面。支架的所有可能的变型可自然地包括与融合器的其他特征有关的其他变型。
在本发明的一些实施例中,融合器(2A、2B)的壁(25)包括至少一个沟槽(20),该沟槽具有尽管允许锚定装置(1)弯曲但仍能通过的宽度。为了允许锚定装置通过,这个沟槽(20)可有基本上大于锚定装置(1)高度的宽度(由沟槽所表示的孔隙的高度)。这个沟槽(20)横穿在壁(25)的***表面和融合器(2A、2B)的上表面或下表面之间的融合器(2A、2B),且具有为锚定装置(1)的曲率半径所设计的取向,以便沿其间植入融合器(2A、2B)的椎骨中的一块椎骨的椎板方向定向该锚定装置。
本发明的一些实施例提供了椎间盘假体(2C)。该假体(2C)包括沿着弧形表面铰接的至少一个第一板(51)和一个第二板(52)。在一个实施例中,特别地在图11A和图11B中可以看出,假体(2C)仅包括两个具有弧形表面的板(51,52)。该两个板(51,52)的这些弧形表面是互补的并且匹配在一起以便通过绕轴线旋转或相对彼此倾斜所述板而允许板(51,52)具有关节/铰接处(articulation),其中所述轴线与所述板的平面几乎垂直。特别地在图11C和图11D中可以看出的另一个实施例中,假体(2C)包括两个板(51,52)和中部核芯(centralcore)(53),该中部核芯相对于板(51,52)中的至少一个板是可活动的。在一个实施例中,这个核芯(53)包括基本上是平面且匹配到一个板(51,52)的基本平面的表面上的表面以及弧形表面,该弧形表面匹配到另一个板(52,51)的互补的弧形表面上。该弧形表面允许以前所述的(倾斜和/或旋转)关节连接,并且该平面表面允许核芯相对于包括平面表面的板的线形运动和/或核芯相对于该板围绕与板的平面几乎垂直的轴线旋转。另外,根据所用的实施例,核芯(53)可包括在至少一个板(51,52)上的互补的配合设备(530),以便限制核芯(53)相对于这个板的旋转运动和/或线形运动。在本发明的一些实施例中,假体(2C)的至少一个板(51,52)包括至少一个沟槽(20),该沟槽具有允许锚定装置(1)尽管弯曲但仍能通过的宽度。这个沟槽(20)可具有基本上大于锚定装置(1)高度的宽度(沟槽所勾勒的孔隙的高度)。与如上所述的具有肌间融合器(2A、2B)的一些实施例类似,椎间盘假体(2C)可具有一个或多个沟槽(20),该沟槽横穿板(51,52)且沿其间植入假体(2C)的椎骨中的一块椎骨的椎板方向定向锚定装置(1)。在一些实施例中,沟槽(20)的尺寸和取向可分别与锚定装置(1)的尺寸和曲率半径相适合。
在本发明的优选实施例中,沟槽(20)的宽度将稍大于锚定装置(1)的厚度,足以允许锚定装置在沟槽内通过,但是通过锚定装置(1)仅稍微增加融合器(2A、2B)或假体(2C)的保持力,而在沟槽(20)内锚定装置没有过大的间隙。在各种实施例中,装置(1)沿着对接端的曲线可被配置为与沟槽(20)相干涉(配合)以便通过锚定装置(1)充分地增加融合器(2A、2B)或假体(2C)的保持力。在本发明的某些实施例中,沟槽(20)的长度可基本与装置(1)的宽度相同,因此一旦锚定装置被***沟槽(20)内则会有很小的或没有间隙。锚定装置(1)的长度可被设计以用于被横穿的沟槽(20)的深度并且被设计成该装置必须穿透椎板的深度。
因此,锚定装置(1),利用其曲率半径和其所***的沟槽(20)的取向,可沿接近轴线被植入,该接近轴线基本沿椎骨间隙的平面,即沿着融合器(2A、2B)或假体(2C)被植入的平面,锚定装置的这种植入方式有利于椎间盘假体或融合器的所有元件和锚定装置接近椎骨间隙的边缘。在一个实施例中,本体(10)所勾勒的弧形的尺寸和曲率半径被设计成使得锚定装置(1)可沿与脊柱的垂直轴线成40°和140°之间的角度且优选地是大约90°的角度的接近轴线被植入到椎板内。对于给定的锚定装置(1),根据椎骨边缘的尺寸该角度可不同,并且根据所用装置(1)的曲率半径和在其对接端和穿透端之间形成的角度(AC),不同的锚定装置(1)的角度也可不同。
在本发明的一个实施例中,具体地在图1(A到D)中可以看出,弧形的且细长的本体(10)包括至少一个弧形板。如图所示这个板可以是基本矩形的,但在没有超出本发明的原理的情况下可自然地有多种形状。同样地,在其他的实施变型中,本体(10)可包括弧形杆,且沟槽(20)具有与这个杆的区段相配合的外形轮廓,不过自然本发明允许其他实施例,特别是关于本体(10)的外形轮廓允许其他实施例。在其他实施变型中(未示出),这个锚定装置(1)的本体(10)可包括两个板(或两个杆),该板或杆通常相互平行且通过安装到融合器或假体中的沟槽(20)中心的杆的内弯部分在对接端被连接在一起,例如,如申请FR2827156(或WO03/005939)和FR2879436(或WO2006/120505)所示和所述的平锚,通过参考合并于此。
锚定装置(1)的穿透端穿到在其间植入融合器(或假体)的椎骨中的一块椎骨的椎板内。在本发明的一个实施例中,该穿透端包括有利于装置(1)穿到椎骨内的倒角(13)或斜角,具体地在图1C和图1D中可以看出。在一个实施变型中,例如如图1B所示,这个穿透端还可包括V-形槽形式的凹口(15),从而有利于穿透端穿到椎板内。对接端邻接抵靠该装置所固定的融合器或假体的表面,从而更加稳固地和牢固地保持锚定装置抵靠椎板。
)在锚定装置(1)的不同的实施变型中,本体(10)的对接端包括至少一个止动元件(11),该止动元件与装置(1)所固定的融合器(2A、2B)或假体(2C)的至少一个表面相配合。用一种互补方式,在融合器(2A、2B)或假体(2C)的不同的实施变型中,在壁(25)的***表面的水平面上,沟槽(20)包括与锚定装置(1)的至少一个止动元件(11)相配合的至少一个止动元件表面(21)。在一个实施例中,具体地在图1A和图1D中可看出,止动元件(11)包括在锚定装置(1)的至少一个面上的凸耳。在所示的示例中,这个止动元件仅包括面向本体(10)所勾勒的弧形构成部分的圆的内部的凸耳,但是该凸耳可采用不同取向。于是融合器(2A、2B)或假体(2C)可仅包括在沟槽(20)下方的、这个止动元件(11)的接触表面。于是融合器(2A、2B)或假体(2C)的止动元件表面(21)可包括用来容纳锚定装置(1)的本体(10)的至少一个面上的凸耳的壁(25)或板(51,52)的***表面。具体地在图1B和图1C可看出的另一个实施例中,止动元件(11)包括在本体(10)侧面上的两个凸耳。这两个凸耳可由被卡配(click-fitted)到沟槽内的两个插销(latch)组成。在这个实施例中,例如融合器(2A、2B)或假体(2C)的止动元件表面(21)可以包括位于沟槽(20)任一侧面上的两个凹口(21)以用来容纳锚定装置(1)的本体(10)侧面上的两个凸耳。例如这两个凹口可有适合卡配锚定装置(1)的凸耳的外形和尺寸。另外,具体地在图11A和图11C中可看出,板的***在沟槽水平面上形成了开口以***锚定装置并且位于这个开口和板的***之间的边缘形成了一种杆,锚定装置(1)的止动元件(11)可安装在这种杆上。因此,装置(1)的止动元件(11)可由被卡配到板边缘上的弧形部分组成。因此,在装置(1)被植入椎骨之间后,该装置(1)是可移动的(在许多实施例中)且可被植入椎骨内及被安装到假体的板上。这个实施例在适当时,允许在最后固定之前调整椎骨之间的假体的位置。
在本发明的某些实施例中,本体(10)包括在其至少一个侧面上的一个或多个弹性凸耳(14),所述弹性凸耳面向对接端并且形成了阻挡锚定装置(1)后撤的止动元件。具体地如图1A和图1B所示,例如这个弹性凸耳(14)可以呈现在本体(10)的两个横向侧面上,但是自然地其可位于本体的单个面上,如上表面或下表面。通过沿对接端的方向定向凸耳(14),这个(或这些)凸耳被用来相对于融合器(2A、2B)或假体(2C)来固定锚定装置(1)。当装置(1)被***沟槽(20)内时,凸耳(14)由于其弹性而折回,因此,即使如以前所述本体(10)的宽度与沟槽(20)的长度大致相同,仍允许装置(1)通过沟槽,因此例如本体(10)中的凹口被用来折叠这些凸耳(14)或利用与沟槽(20)相关的本体(10)的外形轮廓。在本体(10)上的这些弹性凸耳(14)的位置还可被设置以便其沿着融合器(2A、2B)的壁(25)的下表面或上表面或在假体(2C)的板(51,52)的下表面或上表面冒出沟槽(20)的另一侧。在这个实施例中,在壁(25)的下表面或上表面,沟槽(20)可包括与这些凸耳相配合的至少一个止动元件表面。另一方面,本体(10)上的这些弹性凸耳(14)的位置还可被设置以便其不会从沟槽(20)冒出,于是可具有允许凸耳(14)展开并阻挡锚定装置(1)的后撤的至少一个凹槽。
在本发明的某些实施例中,本体(10)装备有槽口(12),该槽口被定向成以便当装置(1)被植入椎骨后可阻挡装置后撤。具体地如图1A和图1B所示,在没有超出本发明的原理范围内的情况下,根据实施变型这些槽口的数目、尺寸及形状可不同。
根据实施例,融合器(2A、2B)可具有不同的外形轮廓。参考附图,以下描述给出了一些非限制性实施变型,但是在没有超出本发明的原理范围内的情况下融合器(2A、2B)和假体(2C)当然可有其他的外形轮廓。例如,图2A到图2E所示的融合器(2A)是基本环形的,且具有基本圆形的***,除了用来***锚定装置(1)的沟槽(20)的位置以外,在该点处融合器(2A)将被植入器械(3、4)保持。融合器(2A、2B)和假体(2C)的外形轮廓当然可能不同,因此根据一些实施例,与融合器(2A、2B)或假体(2C)相接触的所述器械(3、4)的端部的外形也可能不同。例如,融合器(2A、2B)和假体(2C)可具有不同的外形轮廓,该外形轮廓优选地具有为***装置(1)所设计的沟槽(20),和适合与植入器械的一端相配合的附连设备(24)。根据实施例,这些附连设备(24)可与靠近这些附连设备(24)的融合器(2A、2B)或假体(2C)的特殊外形相关联从而允许与器械(3、4)有良好的配合或甚至可能具有适配到器械(3、4)的互补外形上的具体外形轮廓。例如该器械可以包括接触表面,该接触表面紧密配合到靠近凹槽(24)和/或沟槽(20)的假体(2C)的外形轮廓上。同样地,如前所述,融合器(2A、2B)可包括在其中心或非中心处的腔体(23),且该腔体通常可以在给定的椎骨间隙内(如果尺寸允许)植入多个肌间融合器(2A、2B)。因此植入的融合器一般被用来包围在椎骨间隙内生长的骨组织(植入物)并且允许在其间植入骨组织的两块椎骨的融合(关节固定术)。通常也用替代物来代替骨质移植物。无论如何,融合器(2A、2B)的目的是恢复或维持椎骨间的间隙。在植入物生长和椎骨融合之前,融合器(2A、2B)应该恰当地保持在盘间隙中的位置,并且本发明的各种实施例有利于其固定。
在植入用来保持融合器(2A、2B)就位的锚定装置(1)之前,融合器(2A、2B)将会有在盘间隙内运动的风险。在某些实施例中,壁(25)的上表面和下表面中的至少一个表面将包括槽口(22),该槽口阻止植入椎骨间的融合器(2A、2B)在椎骨之间的运动。同样地,假体(2C)的至少一个板(51,52)可被安装到与椎骨相接触的板的表面上,且具有稳定设备,如槽口或鳍状物(fin)或被用来阻止其在椎骨间的运动的任何类型的结构,从而在假体被锚定装置(1)固定之前增加假体的稳定性。因此,至少一个板(51、52)的上表面和下表面中的至少一个表面可包括阻止假体(2C)在其所植入的椎骨之间运动的槽口(22)。根据各种实施例,这些槽口(22)或其他稳定设备可具有不同的取向,以便阻止融合器(2A、2B)或假体(2C)在一个或多个方向的运动。例如,槽口(22)可基本上相互平行并且全部垂直于融合器(2A、2B)或假体(2C)的***轴线,但另一方面,槽口(22)可在融合器(2A、2B)或假体(2C)的不同部分上具有不同的方向,从而阻止任何方向的运动。
在一些情况下,特别是根据必须在其间植入融合器(2A、2B)或假体(2C)的椎骨,期望融合器(2A、2B)或假体(2C)除了保持椎骨间的间隙之外还允许对脊柱前凸或脊柱后凸强加作用。因此,某些实施例提供了通过融合器(2A、2B)的上表面和下表面的参考平面(meanplane)而形成的角度(A1),从而在其间植入融合器(2A、2B)的椎骨上施加了脊柱前凸。例如,图2B表示根据本发明的一个实施例所述融合器(2A)的俯视图。这个融合器基本沿图2B所示的轴线2C-2C、图2C的横截面图的平面被植入。图2C表示出融合器(2A)的下表面和上表面的参考平面(28)形成了沿轴线2C-2C施加脊柱前凸的角度(A1)。另一方面,在某些实施例中,通过融合器(2A、2B)的上表面和下表面的参考平面可以是相互基本平行的。同样地,假体(2C)可包括其上表面和下表面是相互基本平行的板,而可不包括其上表面和下表面形成一定角度的板,该角度例如可施加脊柱前凸或脊柱后凸。因此,在某些实施例中,通过假体(2C)的至少一个板(51、52)的上表面和下表面的参考平面形成了角度(A1),该角度在其间植入假体(2C)的椎骨上施加了脊柱前凸,例如申请FR2869528(或WO2005/104996)和FR2879436(或WO2006/120505)所描述,通过参考合并于此。在其他实施例中,通过假体(2C)的至少一个板(51、52)的上表面和下表面的参考平面是大致相互平行的。对于包括可动的中部核芯(53)的假体而言(该核芯的运动被配合设备(530)限制),脊柱前凸可利用核芯(53)来获得,其中借助于这些配合设备(530)和/或板的配合设备(531)而使得核芯(53)在静止时偏心。
此外,在某些实施例中,融合器(2A、2B)的***壁(25)可包括在其上表面和下表面的至少一个表面的至少一个***部分上的至少一个倒角(250),以便有利于在椎骨之间***融合器(2A、2B)。具体地如图2B所示,融合器(2A)的这个倒角(250)可基本设置在植入假体的轴线上(图2B中的2C-2C)。此外,具体地如图2D所示,这个倒角(250)可被存在于融合器(2A)的下和上两个表面上。这个倒角(250)或斜角的轮廓通过使得其初接边缘(attackingedge)(其首先被***)上的高度稍微小于融合器其余部分的高度而有利于融合器(2A、2B)的植入。同样地,假体(2C)的板可包括在与椎骨接触的板表面的***上、有利于假体(2C)在盘间隙内***的至少一个倒角。
在某些实施例中,融合器(2A、2B)的***壁(25)包括两个叠置(superimposed)的沟槽(20),每个沟槽均面向上表面和下表面中的一个表面,以便允许在其间植入融合器(2A、2B)的每个椎骨中锚定所述锚定装置(1)。同样地,每个板(51、52)可包括沟槽(20),每个沟槽可以面向上表面和下表面中的一个表面,以便允许通过在其间植入假体(2C)的每个椎骨中锚定所述锚定装置(1)来固定每个板(51、52)。在其他实施例中,融合器(2A、2B)可仅具有单一沟槽(20)。在一些实施例中,假体(2C)的仅一个板(51、52)具有沟槽而另一个板没有。
在某些实施例中,融合器(2A、2B)可沿基本沿椎骨间隙的平面设置的轴线被植入,但是该轴线相对于脊柱的垂直轴线是倾斜的,从而允许其例如在椎骨之间在血管的通过点处被植入以便阻止正面进入椎骨间隙。在此种情况下,融合器(2A)应该被植入在如下的植入轴线上,该植入轴线相对于脊柱(矢状轴线)的前后轴线是倾斜的,即意味着在该轴线上脊柱前凸可能不得不产生。如图3B所示,锚定装置(1)的***轴线沿着表示图3C的剖面轴线3C-3C被定向,并且融合器(2A)被植入在该轴线上,但是由于椎骨间隙入口的可能尺寸,所以椎骨的前后轴线可沿着与融合器相关的轴线3D-3D被定向,因此其可被倾斜植入。具体地如图3A所示并且与图3C和图3D比较,融合器(2A)可允许利用其上表面和下表面之间的倾斜角度(A1,图3A)施加脊柱前凸,但是通过其上表面和下表面的参考平面(28)的倾斜轴线是沿轴线3D-3D而不是沿轴线3C-3C定向的。因此,融合器沿轴线3D-3D施加的脊柱前凸比沿轴线3C-3C施加的更大从而该融合器可沿与相当于椎骨的前后轴线(矢状轴线)的轴线3D-3D相关的倾斜轴线3C-3C被植入。因此,根据这个特殊实施例所述的融合器可被倾斜地植入并且允许施加相对于脊柱恰当排列的脊柱前凸。
在其他实施例中,***壁(25)可包括彼此相依设置的至少两个沟槽(20),每个这样的沟槽在融合器(2A、2B)中限定锚定装置(1)的一个可能的***轴线,并且间接地限定在椎骨间的融合器(2A、2B)的一个可能的***轴线。例如,具体地如图4A和图4B所示,融合器(2A)包括两个叠置的沟槽(20),一个沟槽面向在沿两个叠置的沟槽(20)设置的第一轴线(图4B的轴线4C-4C)上的融合器的上表面和下表面中的一个表面,一个沟槽面向在第二轴线(图4B的轴线4D-4D)上的融合器的上表面和下表面中的一个表面。在这个实施变型中,通过对比图4C和图4D可以看出,融合器(2A)可沿轴线4C-4C或沿轴线4D-4D被植入,但是通过融合器上表面和下表面的参考平面的斜面沿着轴线4C-4C被定向。因此这种类型的融合器可因此被倾斜地(沿轴线4D-4D)或正面地(沿轴线4C-4C)植入。以相对类似的方式,图11A到图11D所表示的假体的板(51、52)中的每个板都包括多个沟槽(20)。在所示的示例中,这些沟槽被设置在板的边缘上,但是相对与假体的前后轴线被置于中心或远离中心位置设置。于是这些沟槽限定了骨质锚定装置(1)的两个可能的***轴线,即在前后轴线或倾斜轴线上。此外,假体(2C)的附连设备(24)靠近每个这样的沟槽设置,以便允许在椎骨中装置(1)碰撞过程中假体的抓握。因此,这些附连设备(24)也限定了椎骨间假体(2C)被器械***的两个可能的***轴线,即前后轴线或倾斜轴线。当领会本公开后,本领域的技术人员将会理解本发明允许关于这些附连设备(24)和沟槽(20)的位置和形状的多种变型。顺便在图11A和图11B将会注意到,例如具有两个锚定板的装置(1)彼此没有相同的方向,这可通过它们的沟槽(20)的不同方向来说明。自然地,这些图只是简单地说明,并且绝不是限制,因为当领会本公开后,想象板上沟槽(20)的方向、形状以及位置的任何类型的组合是可能的。
在其他实施例中,肌间融合器可以是椎间孔入路(transforaminal)类型,意味着通过孔被植入。例如在专利申请FR2897259(或美国专利申请序列号为No.11,378,165或WO2007/093900的专利申请)中所描述的融合器,其每一个都被转让给本申请的受让人,并且其每一个都通过参考合并于此,这种类型的融合器是特别有利的,因为其相对较小且因此可通过椎间孔入路路线被植入。用于椎间融合植入物的这种类型的肌间融合器可包括通常限定为弧形(特别是圆弧)的本体,该本体包括侧向凹面、侧向凸面、基本横向上表面、基本横向下表面、在本体的第一纵向末端的端壁以及在与该端壁相对的本体的第二纵向末端的内向弯曲的返回部件(returnpart)。该端壁包括端孔,该端孔被配置为接纳植入器械的杆的保持端并且与本体限定的弧形大致相切。在本发明的各种实施例中,具体地在图8A和图8B中可以看出,融合器(2B)呈圆弧外形,并且包括至少一个沟槽(20),其形状、尺寸及取向适合根据本发明的不同实施例的弧形锚定装置(1)的***。具体地在图8A中可以看出,对于以前所述的融合器(2A),融合器的壁(25)可在内部或非内部形成腔体(23)。此外,具体地在图8A中可以看出,该壁(25)可包括允许植入物生长穿过融合器(2B)的至少一个侧开口(26)。虽然这些侧开口在有关以前所述的融合器(2A)的其他图中没有表示,但是当本领域的技术人员领会本公开后将会认识到适当时这些融合器也可包括这种开口(26)。这种融合器(2B)具有弓形***壁(25),例如勾勒为圆弧。该融合器(2B)的曲率半径和后者的尺寸根据实施例以及根据在其间必须植入它们的椎骨可自然地不同。弧形融合器(2B)的壁(25)在其一端通过在壁(25)所勾勒的弧形表面的内部方向上延伸的返回部件而被延伸。在某些实施例中,具体地在图8B和图8C中可以看出,这个返回部件可包括有利于其植入椎骨间的倒角(250)。如肌间融合器(2A)的第一个实施变型,肌间融合器(2B)的这些椎间孔入路的实施变型在其下表面或上表面的至少一个表面的至少一部分上可装备有槽口(22)。无论何种类型的融合器(2A、2B),这些槽口(22)可具有不同的取向并且呈现线形或圆形形式,或任何其他类型的形式,并且槽口所勾勒的线或圆可相互交叉或不交叉。例如,具体地在图8B和图8C中可以看出,槽口(22)可勾勒成人字形或圆弧形图案。根据肌间融合器(2A)的以前的实施例,以前所述的锚定装置(1)的不同的实施例可自然地适合于融合器(2B)的这些椎间孔入路的实施变型,反之亦然。同样地,只要尺寸允许或适于允许使用,则关于沟槽(20)的不同的实施例可适合于这种类型的椎间孔入路融合器(2B),反之亦然。
在一些实施例中,肌间融合器(2A、2B)或椎间盘假体(2C)将利用特殊器械(3、4)植入,该特殊器械被用来在椎骨间植入肌间融合器(2A、2B)或椎间盘假体(2C)以及可被用来在椎板中植入锚定装置(1)。在这些实施例中,融合器(2A、2B)的***壁(25)或至少一个板(51、52)可包括至少一个附连设备(24),该附连设备与用来植入融合器(2A、2B)或假体(2C)的器械(3、4)的抓握端相配合。如以前所述,这个附连设备(24)可包括容纳抓握设备(321)一端的至少一个凹口(24)。具体地在图3A中可以看出,融合器可包括两个凹口(24),每个凹口设置在沟槽的一侧以便于抓持融合器,但是凹口当然可设置在其他地方,优选地使得这些凹口通过互补的器械便于融合器(2A、2B)或假体(2C)的抓持。具体地在图4A中可以看出,在融合器中的沟槽(20)可与单个凹口(24)相关联,不过即使当如本实施方式示例的融合器(2A、2B)包括多个沟槽(20)时,可以围绕沟槽(20)提供多个凹口(24)。有关本文所描述的附连设备(24)和沟槽(20)的数目和位置的这些不同变型自然地同样适用于融合器(2A、2B)和假体(2C)。
因此本发明的各种实施例还涉及用来在椎骨间植入肌间融合器(2A、2B)或椎间盘假体(2C)以及在至少一个这样的椎骨中植入锚定装置(1)的器械(3、4)。该器械可包括撞针(4),该撞针包括头部(40),其形状和尺寸被设计来推动锚定装置(1)。该器械还可包括在纵轴线上在融合器或假体的所谓的抓握端的第一端和所谓的推进端的第二端之间延伸的细长形导杆(3)。该抓握端包括与附连融合器(2A、2B)或假体(2C)的至少一个器件(24)相配合的至少一个抓握设备(321)。根据实施例,该推进端可包括把手(33),该把手用来推动支撑融合器(2A、2B)或假体(2C)的导杆以便将融合器(2A、2B)或假体(2C)***椎骨间隙内。这个把手也可以由止动元件组成,外科医生可利用例如已知类型的工具在其上轻轻敲击以便在椎骨间引入融合器或假体。当领会本公开后,本领域的技术人员将会意识到本文所述器械(3、4)的不同的元件可以无论融合器(2A、2B)或假体(2C)是何种实施例而存在,除非在本描述中明确指出特殊元件仅涉及以前所述的一种类型的融合器或一种类型的假体。
所述器械的导杆(3)可包括头部(30),其形状和尺寸被设计来至少部分地容纳撞针的头部(40),并且包括至少一个引导表面(31),该引导表面具有与锚定装置(1)的曲率半径大致相同的曲率半径。这个弧形表面(31)可引导这个锚定装置(1)通过肌间融合器(2A、2B)或椎间盘假体(2C)的沟槽(20),从而使得锚定装置(1)进入在其间植入融合器(2A、2B)或假体(2C)的椎骨中的一块椎骨的椎板中。
所述导杆(3)可包括细长形本体(32),该本体允许无需太多空间即可进入椎骨间隙。所述撞针(4)还可包括细长形本体(42),该本体相对于导杆(3)的本体(32)滑动。在某些实施例中,撞针(4)包括把手(41),该把手用来使得撞针的本体(42)相对于导杆(3)滑动。这个把手还可起到止动元件的作用,在其上外科医生可利用例如已知类型的工具轻轻敲击以便使得锚定装置(1)穿到椎板内。此外,在某些实施例中,撞针(4)可包括至少一个止动元件(43),该止动元件限制了撞针(4)头部(40)在导杆(3)的头部(30)内的穿透。在某些变型中,这个止动元件的位置可沿着撞针(4)的本体(42)被调整,用于调整撞针的穿透能力使之适合导杆(3)的头部(30)的尺寸和所用锚定装置(1)的尺寸。例如,如前所述,锚定装置(1)可具有可变化地适应周围环境和导杆头部(30)的长度,并且特别地弧形引导表面(31)的尺寸也将根据锚定装置(1)的长度被设计。
根据实施例,如图6B所示,导杆(3)的本体(32)可具有两个杆或管(32),不过导杆(3)也可具有一个杆或一个管,即使导杆包括多个抓握设备(321),优选地允许这些设备(321)固定融合器或假体。具体地在图6D中可以看出,在某些实施例中,抓握设备(321)可由杆(321)组成,这些杆自由地配合在管(32)内以构成导杆(3)的本体。在某些实施例中,这些杆可不在本体(32)内。在不同的实施例中,抓握设备(321)可包括杆的一端,当用把手(33)操纵该端时,该端在导杆(3)的本体(32)中滑动,从而进入和离开融合器(2A)的凹口(24)。在这些实施变型中,这些抓握设备(321)在其末端可包括螺纹以便螺纹连接到融合器(2A、2B)的凹口(24)内,该凹口可包括螺纹孔。在某些实施变型中,杆(321)因此可包括安装到凹口(24)的螺纹孔内的螺纹端,从而当通过把手(33)操纵该杆时,可固定融合器(2A)。在其它变型中,该杆的尺寸可被调整以精确穿到凹口内并且通过此精确调整允许保持融合器。杆(321)和凹口(24)的这些不同的变型自然地也可适用于假体(2C)。例如,图11A到图11D所表示的假体包括板(51、52),该板包括容纳这些抓握设备(321)的凹口(24)。在所表示的实施方式的示例中,抓握设备(321)可靠近导杆(3)的头部(30)的上表面和下表面,从而使这些设备(321)允许假体(2C)的两个板(51、52)的正确抓握。本发明的各种实施例允许附连设备(24)和抓握设备(321)的其他实现方法,例如如前所述。此外,在图11C和图11D的假体(2C)的实施方式的示例中,该假体包括两个板(51、52)和核芯(53),附连设备(24)还可包括位于核芯上的附连设备,因此后者也通过器械(3、4)来保持。例如,面对假体(2C)的导杆头部(30)的表面可具有与两个板和核芯组件互补的外形,以便环抱假体的外形并且保持假体元件的稳定。
在图6(A到E)和图7(A到D)所表示的实施例中,本体(32)包括用来引导撞针(4)的引导板(34)。在这些实施例中,该板(34)包括在导杆本体(32)的轴线上引导撞针的凹槽。在其他可能的实施例中,例如如图9A所示,撞针(4)的本体(42)可被安装成在导杆的本体(32)内滑动,但是本发明自然允许其他实施变型,优选地允许撞针(4)相对于头部(30)被引导并且相对于导杆(3)滑动。
具体地在图5A中可以看出,导杆(3)的头部(30)包括腔体(300),其形状和尺寸被设计为接纳锚定装置(1)和至少部分地接纳撞针(4)的头部(40)。本发明的各种实施例自然允许头部(30)的不同实施例以及本文仅作为说明所给出的示例。导杆的头部(30)可包括至少一个通道(320),融合器或假体的抓握设备(321)将被***通过该通道(320)从而在导杆(3)的端部保持融合器或假体。在图5A和图5B所表示的实施例中,这个头部包括在腔体(300)两侧上的两个相同的通道,因为头部(30)的这个实施例被设计成安装到具有两个抓握设备(321)的导杆(3)上。当领会本公开后,本领域的技术人员将会意识到本发明将允许使用仅一个抓握设备(321)或,另一方面,通过减小抓握设备的尺寸和使其围绕腔体具有不同分布来增加它们的数量,例如在被植入的融合器上提供互补的凹口。此外,给定的器械(3、4)可用来植入不同类型的融合器(2A、2B)或假体(2C),优选地具有被设计成互补的导杆(3)的抓握设备(321)和融合器(2A、2B)或假体(2C)的附连设备(24)。例如,包括图5E所表示的头部(30)的器械可用来植入图4A的融合器(2A),即使在这个示例中将不会用到导杆(3)的一个抓握设备(321)。在导杆(3)的头部(30)的腔体(300)内可具有锚定装置(1)的至少一个弧形引导表面(31)。在作为示例所述的实施例中,这个引导表面(31)可包括至少两个弧形凹槽(31),每个凹槽位于这个腔体(300)的一侧上以在其本体(10)的两侧上引导锚定装置(1)。于是撞针(4)的头部(40)被设计为从这些凹槽(31)的一端到另一端地穿到腔体(300)内,从而推动锚定装置(1)从这些凹槽(31)的一端到另一端。在图5(A到E)所表示的实施例中,头部(30)的腔体(300)可接纳两个引导元件(310)(在图5C和图5D中具体可见),每个引导元件包括引导凹槽(31)并且每个设置在腔体(300)的一侧上,具体地在图5E中可以看出。在这个实施方式的示例中,引导元件(310)通过将头部(30)***腔体(300)内而与头部(30)装配在一起,该腔体(300)可包括用来使这些引导元件(310)固定的固定设备。例如在其他实施方式的示例中,例如图8C和图9(A到C)所表示的导杆(3)的头部(30),该头部(30)将直接由在腔体(300)内侧上的引导凹槽(31)组成。在这个示例中,该头部可由两个组装部件组成从而便于弧形凹槽(31)的加工制造。
在某些实施例中,如图3A、图4A和图5A所示,融合器(2A)的凹口(24)可靠近沟槽(20)制造,并且抓握设备(321)的通道(320)可靠近腔体(300),以便允许融合器靠近在撞针(4)作用下锚定装置(1)可能在融合器上施加压力的位置处正确地抓握。附连假体(2C)的设备(24)自然可以相同方式组成。
具体地在图6C和图9B中可以看出,抓握设备(321)在抓握端的位置处可伸出到导杆(3)的头部(30)之外。具体地在图7A和图7B或在图9A和图9C中可以看出,导杆可允许通过使得引导表面(31)的一端终止在融合器(2A、2B)内的沟槽(20)内来保持融合器(2A、2B)并且使得引导表面(31)的另一端仍然保持能够***锚定装置(1),从而抓握该融合器。在这些实施例中,当融合器(2A、2B)已经被安装到抓握设备(321)上后,锚定装置(1)可被***该头部(30)内,但是其他实施例,其可能是不太有利的但是植入费用较低,可能需要在融合器(2A、2B)安装之前***锚定装置(1)。这些变型还可适用于假体(2C),其可以相同方式设计并且因此可用与描述融合器(2A、2B)的相同器械植入。
对于椎间孔入路(transforaminal)融合器(2B),所述器械可允许融合器实际上在其全部长度上被支持,这可有利于融合器(2B)***椎骨间隙内并且防止该器械损坏。在融合器(2B)的这个实施例中,抓握设备(321)可以是弧形杆的一端,例如压舌板,其可具有与具有勾勒成弧形的***壁(25)的融合器(2B)的曲率半径基本相同的曲率半径。在这个实施例中,凹口(24)可设置在返回部件上,该返回部件在由壁(25)构成部件所勾勒的圆弧的圆心方向上延伸由融合器(2B)的壁(25)所勾勒的圆弧的一端。压舌板可在该返回部件和由融合器(2B)的壁(25)所勾勒圆弧的另一端之间环抱融合器(2B)的外形轮廓。在该壁(25)的所述另一端,融合器(2B)可有利地包括第二抓握设备以支持融合器(2B)。在椎间孔入路融合器的某些实施例中,第二抓握设备可被设置在压舌板的基座,但是在支承压舌板的侧面的相对一侧上。第二抓握设备可包括第二凹口(241),该凹口用来容纳安装到导杆(3)的杆(340)上的插销(341)。如以前所说明的导杆的本体(32)和撞针的本体(42)或抓握设备(321),这个杆(340)可被自由安装在导杆的本体(32)内或安装到外部上,因此优选地相对于头部(30)引导该杆。这个杆(340)可通过把手来操纵并且可在插销(341)与第二凹口(241)啮合的至少一个位置以及插销(341)从第二凹口(241)抽出并且因此释放融合器(2B)的位置之间枢转。
在植入器械(3、4)的某些实施例中,特别适合椎间孔入路融合器,其***必须沿相对于椎骨的前后轴线的弧形或倾斜轴线实现,导杆(3)的头部(30)可基本沿融合器(2B)所勾勒的弧形的曲率半径呈弧形或弯曲。因此,弯曲器械允许更容易地通过孔,尽管其可用于其它情况下。在导杆(3)的头部(30)的这个弯曲实施例中,撞针(4)的头部(40)可具有几乎呈弧形或弯曲的外形因此其具有与在导杆(3)的头部(30)内的通道相匹配的曲率半径。此外,在特别有利的变型中,撞针(4)的这个头部(40)可被安装到旋转轴线(425)上,该旋转轴线安装在撞针的本体(42)上。这个轴线(425)允许撞针的头部(40)枢转以便通过在导杆(3)的头部(30)内的弧线或弯曲处,具体地在图9B中可以看出。在另一个实施变型中,撞针(4)可以是直的并且被设计为在与例如图9B的轴线9C-9C大致平行的倾斜轴线上***头部(30),且该头部(30)之后具有足够尺寸的开口来允许撞针(4)的头部(40)的引入。
本发明允许本文所描述的实施例之间的多种组合。特别地,此外,本发明还涉及在两块邻近椎骨之间的脊椎植入物的植入***。在一些实施例中,此***包括至少一个脊椎植入物(2A、2B、2C)和在至少一块椎骨中固定植入物的至少一个锚定装置(1)。特别地,该脊椎植入物(2A、2B、2C)包括根据本发明的实施例的肌间融合器(2A、2B)或根据本发明的实施例的椎间盘假体(2C),并且锚定装置(1)包括根据本发明的实施例的锚定装置(1)。在一些实施例中,此***还包括根据本发明的实施例的器械(3、4)。
此外,本发明还涉及***脊椎植入物的方法。在一些实施例中,该方法包括以下步骤:
-根据本发明实施例提供锚定装置(1);
-提供脊椎植入物(2A、2B、2C),例如根据本发明的实施例的肌间融合器(2A、2B)或根据本发明的实施例的椎间盘假体;
-提供根据本发明的实施例的植入器械(3、4);
-用植入器械(3、4)的抓握装置来抓持脊椎植入物(2A、2B、2C);
-在脊柱的相邻椎骨之间的椎骨间隙内***脊椎植入物(2A、2B、2C);
-使用植入器械的撞针,***锚定装置(1)使其通过植入器械(3、4)的导杆头部并通过植入物内的孔(20),且锚定装置(1)横穿植入物(2A、2B、2C)的至少一部分;以及
-使用植入器械的撞针,在相邻椎骨中的一块椎骨内植入锚定装置(1)的穿透端。
在一些实施例中,该方法还可包括通过使得锚定装置的纵向轴线沿接近轴线来放置锚定装置(1)的步骤,其中所述接近轴线基本沿椎骨间隙的平面。在一些变型中,根据在脊椎植入物中的孔(20)的位置,该方法可包括沿相对于椎骨间隙的平面是斜轴线的接近轴线定向锚定装置的步骤。在一些实施例中,根据本发明的弧形锚定装置可被使用以避免外科医生围绕椎骨间隙清理太多空间。例如,一些肌间融合器或椎间盘假体已知包括延伸出椎骨间隙、抵靠相邻椎骨中的至少一个椎骨的***表面的壁或凸缘。假体或融合器基本存在于椎骨间隙的平面中并且可包括与脊椎轴线基本平行(因此与该间隙的平面正交)延伸的壁或凸缘。此壁或凸缘通常要求外科医生清理椎骨间隙周围的椎骨表面以便与椎骨正交地植入锚定装置,并且另外清理到椎骨表面的通路以使用工具来锚定所述锚定装置。因为锚定装置具有曲率,所以其可以使用倾斜的接近轴线并且可通过设置在融合器或假体的壁中的孔(20)被压紧在椎骨中,此孔与以前所述的锚定装置(1)相适合,但是具有与锚定装置的倾斜的接近轴线相适合的取向。因为该锚定装置将沿倾斜轴线被植入,所以外科医生仅须清理壁或凸缘将要邻接的椎骨表面并且不必清理更多的组织来使工具通过。这样使用锚定装置减少了移植的传染性,因为对于锚定装置的***,外科医生不需要在椎骨间隙周围清理比植入其本身所需间隙更大空间。
在领会本发明后,本领域的技术人员将意识到在不偏离本发明的原理的情况下,允许实施例有多种其他具体形式。因此,除所附权利要求外,这些现有的实施例必须被认为仅仅是说明性的,并且不应局限于具体说明的本发明可在前述给定范围所限定的范围内修改。
Claims (10)
1.在至少一块椎骨中锚定脊椎植入物(2A、2B、2C)的锚定装置(1),其包括在穿透端和对接端之间延伸的在纵向轴线上的细长外形的本体(10),所述锚定装置的特征是所述本体(10)具有沿着所述纵轴线、勾勒成弧的弧形外形,所述弧形外形的尺寸和曲率半径被设计成使得所述锚定装置(1)能通过没有变形地被***通过设置在所述脊椎植入物上的至少一个孔(20)并横穿所述植入物的至少一部分而被植入到椎骨的表面,所述孔(20)的形状、尺寸和取向被设置成允许所述锚定装置(1)尽管其具有曲率但没有变形地通过,因此所述锚定装置(1)穿到至少一块椎骨表面内并且使所述脊椎植入物固定到该椎骨表面上。
2.根据权利要求1所述的锚定装置(1),其特征是所述本体(10)所勾勒的圆弧的尺寸和曲率半径被设计成使得所述锚定装置(1)在与脊柱的垂直轴线成近似90°角度的接近轴线上植入到椎板中。
3.根据权利要求1和2中的一项权利要求所述的锚定装置(1),其特征是弧形且细长形的所述本体(10)包括至少一个弧形板。
4.根据权利要求1-3中的一项权利要求所述的锚定装置(1),其特征是所述穿透端包括有利于所述装置(1)穿到所述椎骨中的倒角(13)或斜角。
5.根据权利要求1-4中的一项权利要求所述的锚定装置(1),其特征是所述本体(10)装备有槽口(12),其中所述槽口(12)被定向成使得在其被植入椎骨后可阻止所述装置(1)的后撤。
6.根据权利要求1-5中的一项权利要求所述的锚定装置(1),其特征是所述本体(10)的所述对接端包括至少一个止动元件(11),该止动元件用来与所述装置(1)将要固定的所述融合器(2A、2B)或假体(2C)的至少一个表面相配合。
7.根据权利要求6所述的锚定装置(1),其特征是所述止动元件(11)包括在所述锚定装置(1)的至少一个面上的突出凸耳。
8.根据权利要求6所述的锚定装置(1),其特征是所述止动元件(11)包括在所述本体(10)的侧面上的两个突出凸耳。
9.根据权利要求1-8中的一项权利要求所述的锚定装置(1),其特征是所述本体(10)包括在其至少一个侧面上、面向所述对接端并且形成了阻止所述锚定装置(1)后撤的止动元件的弹性凸耳(14)。
10.肌间融合器(2A、2B),其包括壁(25),该壁(25)形成用以接纳骨组织移植物或替代物的腔体(23),所述肌间融合器的特征是所述***壁(25)包括横穿所述融合器(2A、2B)的至少一部分的至少一个孔(20),所述孔(20)的形状、尺寸和取向是与根据前面任意一项权利要求所述的锚定装置(1)的尺寸和曲率半径相适合的,以便允许此锚定装置(1)尽管其具有曲率但没有变形地通过该孔(20),从而沿在其间将植入所述融合器(2A、2B)的椎骨中的一个椎骨的椎骨表面方向来定向所述锚定装置(1),所述锚定装置(1)的尺寸和曲率半径被设计成使得所述锚定装置(1)可通过被***通过所述孔(20)而被植入到椎骨表面内。
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CN200880025422.7A CN101878007B (zh) | 2007-06-08 | 2008-06-09 | 肌间融合器、椎间盘假体、锚定装置及植入器械 |
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