CN101394813A - 用于脊柱关节重建的修复器件 - Google Patents
用于脊柱关节重建的修复器件 Download PDFInfo
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- CN101394813A CN101394813A CNA2007800075097A CN200780007509A CN101394813A CN 101394813 A CN101394813 A CN 101394813A CN A2007800075097 A CNA2007800075097 A CN A2007800075097A CN 200780007509 A CN200780007509 A CN 200780007509A CN 101394813 A CN101394813 A CN 101394813A
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- prosthetic device
- joint
- connection element
- vertebra
- joint component
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Abstract
修复器件,用于置于上椎骨和下椎骨之间所限定的椎间隙,以提供所述上和下椎骨的关节运动,所述修复器件包括:上关节部分——其被设置为至少部分置于所述椎间隙,和下关节部分——其被设置为至少部分置于所述椎间隙。所述下关节部分可以被设置为与所述上关节部分协作,以便提供所述上和下椎骨的关节运动。连接元件可以在脊柱的通常方向延伸。所述连接元件被设置为被固定到所述上和下椎骨的至少一个上,以便至少部分牢固固定所述上边关节部分和下边关节部分的所述一个到适当位置。
Description
背景技术
椎间盘关节成形术(Disc arthroplasty)是治疗受伤的、退化的或者患病的脊柱关节的一种方法。一些椎间盘关节成形术治疗包括用保持活动性的脊椎间盘取代受伤的关节椎间盘,这能允许脊柱关节咬合或活动。通常用螺丝钉作为固件将这些保持活动的脊椎间盘结合到邻近的椎骨上。有时,螺丝钉的位置可能低于期望,可能导致椎骨的一些弱化,和可能不充分地将保持活动的脊椎间盘固定在适当的位置。这样的低于期望的结合能够限定保持活动性的脊椎盘的可操作性。
所需要的是修复器件,用于插入椎骨空间之间,其可以被较好地固定在脊柱上或更有效地提供期望的特性。此处公开的后关节取代器件克服了先有技术的一个或多个问题。
发明概述
在一个示例性的方面,本公开是关于修复器件,其用于在上边椎骨和下边椎骨之间限定的椎骨空间的取代,以提供上边椎骨和下边椎骨的关节活动。所述修复器件可以包含上边关节部分,其被配置为至少部分地放置于椎骨间空间中,和下边关节部分,其被配置为至少部分地放置于椎骨间空间中。下边的关节部分可以被配置为与上边的关节部分配合,以提供上边和下边的椎骨的咬合活动。
在另一个方面,结合元件可以从上边关节部分和下边关节部分中的一个上,按照脊柱的总体方向延伸出来。结合元件可以被配置为固定到上边椎骨和下边椎骨的至少一个上,以至少部分地,将所述上边关节部分和下边关节部分的至少一个紧固在适当的位置。
在另一个示例性方面,该公开内容针对保持活动的修复器件部件,用于取代限定在上边椎骨和下边椎骨之间的脊椎空间。所述修复器件可以包括被配置为至少部分地放置在椎骨空间的关节部分。所述关节部分可以被配置为与配对部分协作,以提供上边椎骨和下边椎骨的咬合活动。所述关节部分可以包括主体和结合元件。
在另一个方面,所述主体可以被配置为相对于所述上边和下边的椎骨之一个而被固定。所述结合元件可以被配置为将所述上边和下边椎骨之所述一个固定在椎骨空间外、并且与椎骨空间隔开的位置。
在另一个方面,结合元件可以是挠性的。所述主体可以被配置为相对于上边和下边椎骨中的一个而被固定,并且所述挠性结合元件可以被配置为结合到所述上边和下边椎骨的另一个上。
在另一个示例性的方面,该公开内容针对修复器件,用于取代在上边和下边椎骨之间所限定的椎骨空间。所述器件可以包括保持活动的修复器件部件,作为第一关节部分。第二关节部分可以被配置为与第一关节部分配合,以提供上边和下边椎骨的结合关节活动。第二个关节部分可以被配置为相对于所述上边和下边椎骨的另外一个而被固定。
在另一个示例性的方面,该公开内容针对在上边和下边椎骨之间限定的脊椎空间中移植修复器件、以提供上边和下边椎骨的结合关节活动的方法。所述方法可以包括将上边的关节部分至少部分地放在椎骨间的空间和将下边的关节部分至少部分地放在椎骨间的空间中。所述下边的关节部分可以配合上边的关节部分,以提供上边和下边椎骨的结合关节运动。从上边和下边的关节部分之一个上,在脊柱的总体方向上,延伸出来的结合元件可以被固定到处于椎骨间空间之外的所述上边和下边椎骨的至少一个上,以至少部分地将上边和下边的关节部分的所述一个固定在适当的位置。
在一些示例性的方面,此处公开的所述关节取代器件可以包括在以下先前专利申请中所公开的一个或者多个特征,通过引用将它们的全部内容包含在此:
2005年1月7日提交的美国发明专利申请序列号11/031,602,标题为“Spinal Arthroplasty Device and Method;”
2005年1月7日提交的美国发明专利申请序列号11/031,603,标题为“Dual Articulating Spinal Device and Method;”
2005年1月7日提交的美国发明专利申请序列号11/031,780,标题为“Split Spinal Device and Method;”
2005年1月7日提交的美国发明专利申请序列号11/031,904,标题为“Interconnected Spinal Device and Method;”
2005年1月7日提交的美国发明专利申请序列号11/031,700,标题为“Support Structure Device and Method;”
2005年1月7日提交的美国发明专利申请序列号11/031,783,标题为“Mobile Bearing Spinal Device and Method;”
2005年1月7日提交的美国发明专利申请序列号11/031,781,标题为“Centrally Articulating Spinal Device and Method;”和
2005年1月7日提交的美国发明专利申请序列号11/031,903,标题为“Posterior Spinal Device and Method。”
附图简要说明
图1是椎骨柱部分的侧面图的绘图显示;
图2是限定椎骨间空间的一对邻近椎骨体的侧视图的绘图显示。
图3是示例性椎骨间修复器件的等角视图的绘图显示。
图4是示例性椎骨间修复器件的俯视图的绘图显示。
图5是示例性椎骨间修复器件的侧视图的绘图显示。
图6是示例性椎骨间修复器件的端视图的绘图显示。
图7是表明椎骨间修复器件的内部特征的绘图显示。
图8A和8B是处于椎骨间空间中的椎骨间修复器件的绘图显示。
图9是在下边椎骨上放置的椎骨间修复器件的绘图显示。
图10是等角视图的绘图显示,其图示了根据本公开内容另一个方面所述的示例性椎骨间修复器件,其中紧固件是分解的。
图示了示例性椎骨间修复器件的侧视图。
图12图示了在椎骨间盘空间内的示例性椎骨间修复器件。
发明详述
本发明一般涉及椎骨重建器件,以及,更具体地说,涉及用于移植的椎骨间修复器件。为了促进理解本发明的原理,现在将参考在附图中说明的实施方式或者实例,特定的语言将被用于说明同一事物。然而,可以理解的是,发明的范围不因此受限制。所述的实施方式的任何变化和进一步的改良,和此处所述的发明原理的进一步应用,正如对本发明所述技术领域的普通技术人员而言那样,是可以想到的。
图1显示了脊柱10的部分的侧视图,说明了被天然的椎间盘D1、D2、D3隔开的由相邻的上边和下边脊椎V1、V2、V3、V4构成的群。四个椎骨的说明仅被意欲作为例子。另一个例子是骶骨和一个椎骨。
为了进一步的实施例,通过参照图2叙述两个椎骨。所述两个椎骨形成脊柱节段12,其包括上椎骨14和下椎骨16。一些类型的椎间盘关节成形术,需要将已经位于所述两个椎骨14、16之间的一些或所有的天然椎间盘经过椎间盘切除术或类似的手术方法去除。去除患病的或者退化的椎间盘导致在上椎骨和下椎骨14、16之间形成椎间空间S。虽然图2的说明一般地描述了作为腰椎关节的脊柱节段12,但是可以理解的是,本公开内容的所述器件、系统和方法也可以被用于脊柱的所有区域,包括颈部和胸部区域。应理解的是,在本公开内容的说明书和权利要求书中,术语上边和下边椎骨也包括不直接形成椎间隙S、但是位于分别高于或低于直接形成椎间隙S的椎骨之位置的椎骨。
一些常规的脊柱修复器件用前路手术(anterior procedure)安装,需要医师使用令人痛苦的和有时有创伤的手术进入脊柱。一旦假体用前路手术安装后,瘢痕组织可以在敏感的血管上生成。如果需要第二个手术,医师可以被要求将瘢痕组织除去,以接近以前放置的假体。这个敏感的手术可以导致患者附加的痛苦。此处公开的椎骨间修复器件可以比现有的器件优越,因为它可以用后路手术安装。因此,医师不必接近或破坏存在于脊柱前边的重要血管。而且,如果第二个手术是必需的,医师容易接近先前放置的假体,不用将瘢痕组织从敏感的血管上除去。
因此,所述程序可能被简化并可能对患者导致较小的痛苦。
一些移植手术需要放置将修复器件固定在适当位置的固件。在一些常规的系统中,这些固件一般被打入椎骨体。然而,一些患者,包括年老患者的椎骨体,可能变得脆弱,并变成用于锚定的较差期望位置。由于这个原因,随着时间的过去,椎骨体中的固件可能变得松动和开始摇晃,风险是移植的修复器件的移位。所述固件也可能出现另外的问题。例如,固件一般被打入椎骨体的侧面,仅仅高于或低于椎骨空间。
因此,固件可能浅浅地位于椎骨的表面,很接近终板。这个浅位置可能潜在地减慢骨头在终板处的生长速度,因为骨头与修复器件的表面紧密配合。另外,固件的浅位置可能使椎骨的终板脆弱,并且如果遭受极限负荷,椎骨可能劈开,潜在地需要附加的外科手术和更换修复器件。此处公开的椎骨间修复器件可以允许将器件固件导入与椎骨终板隔开的位置的椎骨中,在一些情况下,导入椎弓根,而不是椎骨体中。
图3-7显示了可植入图2中椎间隙S的修复器件20的几个视图。图8A和8B显示了在椎骨空间S就位的修复器件20。所述修复器件20允许椎骨14相对于椎骨16具有结合关节,以提供脊柱关节的活动。以类似于天然椎间盘如椎间盘D1-D4中的任意一个的方式,进行尺寸变化以便适合椎骨间空间的高度,修复器件20对椎骨提供支持和稳定。图3是修复器件20的等角侧视图,图4是俯视图。图5是侧视图,图6是端视图。图7显示了修复器件20的部分,其分别显示了内部特征。参照图3-7,修复器件20包括上边关节部分22和下边关节部分24。所述上边关节部分22包括由椎间盘段26形成的上边主体,后段28,以及在椎间盘与后端26、28之间延伸的桥30。同样地,下边关节部分24包括由椎间盘段32形成的下边主体,后段34,以及在椎间盘与后端32、34之间延伸的桥36。
上边和下边的关节部分22、24可以由任何合适的生物相容的材料组成,其包括金属,如钴-铬合金、钛合金、镍钛合金和/或不锈钢合金。陶瓷材料如铝氧化物或氧化铝、锆氧化物或氧化锆、致密金刚石颗粒和/或热解碳也是可以适合的。聚合物材料也可以使用,包括聚芳醚酮(PAEK)家族的任何成员,如聚醚醚酮(PEEK)、碳强化PEEK或聚醚酮酮(PEKK);聚砜;聚醚酰亚胺;聚酰亚胺、超高分子量聚乙烯(UHMWPE)和/或交联的UHMWPE。包括上边关节部分22和下边关节部分24的各段可以由不同的材料组成,由此允许金属对金属、金属对陶瓷、金属对聚合物、陶瓷对陶瓷、陶瓷对聚合物或聚合物对聚合物的构造。
在所示的示例性的实施方式中,每个上边和下边的关节部分22、24是由单件材料完整地形成或者模制的。在其它的实施方式中,上边或下边关节部分22、24任一个的一个或多个的椎间盘段、后段和桥段可以单独形成并结合到其它段的一个或多个。这些实施方式中的结合可以用本技术领域已知的任何固定机制完成,包括,在其他方式中,例如,螺纹连接、螺栓连接或者锁存器连接。在那些实施方式中,所述椎间盘段、后段和桥段也可以由不同的材料组成。
上边关节部分22的椎间盘段可以包括骨头接触表面38和与骨头接触表面38相对的内表面44。第一个关节部分42可以形成内表面44(图7)之一部分。在所示的实施方式中,第一个关节表面42是隐窝。同样地,下边关节部分24的椎间盘段32可以包括与内表面48相对的骨头接触表面40,其中第二个关节部分表面46形成内表面48(图7)之一部分并被配置为与第一个关节表面42紧密配合。在所示的实施方式中,第二个关节表面46是突出面。
第一个关节表面和第二个关节表面42、46一起可以形成咬合关节,其允许上边和下边的关节部分22、24彼此相对咬合。该咬合依次可以允许上边椎骨14相对于下边椎骨16的咬合运动,并且在一些实施方式中,可以允许与天然椎间盘所提供的活动相似的活动。在所示的实施方式中,第二个关节表面46是部分球体,其可以在第一个关节表面42内旋转或平移,形成松散限制的球和窝型关节。虽然显示为球和窝关节,但是第一个和第二个关节表面42和46可以是任何形状或设计,其允许上边和下边关节部分22、24中的一个相对于上边和下边关节部分22、24的另一个活动。例如,第一个和第二个关节表面42、46可以包括槽和隐窝、球和碟或其它形状的特征。在一些实施方式中,第一个和第二个关节表面42、46由不同于椎间盘段26、32的剩余一个的材料构成,以提供合适的咬合。
上边和下边关节部分22、24的骨头接触表面38、40可以包括增强移植的修复器件20之固定作用的特征或涂层。例如,表面38、40可以被粗糙化,如通过化学蚀刻、喷丸处理、砂磨、碾磨、使成锯齿状和/或金刚石切刻变得粗糙化。上边和下边关节部分22、24的所有或部分骨头接触表面38、40涂有生物相容的和骨传导的材料,如羟基磷灰石(HA)、磷酸三钙(TCP)和/或碳酸钙,以促进骨头的生长和固定。可选地,骨诱导性涂层,如来自转化生长因子(TGF)β超家族的蛋白,或骨形态发生蛋白,如BMP2或BMP7,可以被使用。其它合适的特征可以包括穗、脊和/或其它表面质地和特征。
在所示的示例性实施方式中,任选的上边和下边骨头连接器50、52分别在骨头连接表面38、40上形成。这些骨头连接器50、52,以有助于将上边和下边关节部分22、24固定在适当位置的方式向上边和下边椎骨14、16延伸。在所示的实施例中,骨头连接器50、52是龙骨脊,其被配置为延伸进入在椎骨终板内形成的凹口或槽内。所述骨头连接器也可以是系列的脊、突出或其它的表面特征,其帮助于将修复器件20固定在适当的位置。
所述桥段30、36分别从椎间盘间段26、32向后延伸。在所示的实施方式中,所述桥段30、36基本上沿着修复器件20的纵向中心线58(图4)延伸。在其它的实施方式中,桥段没有与椎间盘段的纵向中心线对齐,但是可以弯曲或成角度离开该纵向中心线。
后段28、34可被置于桥段30、36的末端,并且在一些实施方式中,其可被设置以适合于邻近椎骨14、16的突起。下边关节部分24的后段34可包括尾60,其通常在沿脊柱的方向延伸;并且通过上边关节部分22的后段28。
尾60可连接到桥段36,并且在示出的实例中,其通过桥段36中的弯曲形成。向上延伸,尾60可至少部分安排在高于桥段36的位置。尾60的一部分可形成运动制动器66(图5),其被设置以限定上边和下边关节部分22、24之间的结合关节的范围。在所示的实施方式中,运动制动器66在具有一定长度的尾60中的一个弯曲:设定该长度以与上边关节部分22一起工作以限制上边和下边关节部分22、24的关节旋转的可行范围。应该注意尾60可以是基本上直的或者可以是弯曲的、有角度的或者其它方式形成的。在一示例性实施方式中,尾60可包括具有与突出的关节面46的弯曲同心的曲线。
上边关节部分22的后段28包括在其中形成的孔70,其被设置为接受下边关节部分24的尾60。在所示的实施方式中,后段28的一部分形成运动制动器69,其被设置为与尾60上的运动制动器66合作。因此,当上边和下边关节部分22、24如图5中所示进行装配,运动制动器66和运动制动器69合作限制修复器件20的结合关节的范围。另外,孔70被设置,以便当关节面42、46配对时,尾60以关节运动在该范围内仍可以自由发生的方式延伸通过孔70。
因为运动制动器66、69的结构,当处于图2的椎间隙S的外面时,可设置上边和下边关节部分22、24进行组装。此外,在椎间隙S内,上边和下边关节部分22、24很难解开。因此,在植入后,上边和下边关节部分22、24变得不对齐的机会被减小。而且,尾60和孔70减少上边和下边关节部分22、24的一个绕上边和下边关节部分22、24的另一个发生轴旋转的机会。因此,尽管形成球窝关节,但是上边和下边关节部分22、24被连接在一起,所以孔70和尾60限制轴向旋转。
在所示的实施方式中,上关节部分包括结合元件(附着元件)——例如板72,从上关节部分22的上面主体向上延伸——和紧固件74。设置板72连接紧固件74至上面的主体,并设置板72位于沿邻近椎骨的椎弓根,以便紧固件74延伸入椎弓根(图8A和8B)。在所示的实施方式中,板72具有比桥30更大的宽度,并且板72从所述桥延伸。孔76使紧固件74通过板72进入邻近椎骨。孔76包括扇形轮廓78,在所示的实例中,所述扇形轮廓78由交叠孔形成,每个孔允许紧固件74通过。在所示的实例中,扇形轮廓78由每一个示出两个孔的单独部分形成,这为紧固件提供四个位置选择。
因此,医师植入修复器件20可选择哪一个可用的选择,以插入紧固件74。应该注意:在其它实施方式中,可使用不同数量的孔或洞。
紧固件74可以是骨螺钉,其具有用于插入骨的螺纹部分80,以及可操作地挤压板72以将该板固定于骨的头部82。紧固件74可以在基本上通过纵轴形成的平面上插入骨中,并且在所示的实施方式中,紧固件74基本上平行于纵轴。在所示实施方式中,头部本身的直径大于板72的扇形轮廓78的孔的直径,并且其与该板接触。垫圈或其它硬件可与紧固件74一起使用,以将板固定于骨。适合用于板72的一个示例性紧固件,在下面参考图10进一步描述。尽管被示出为螺丝钉,但是紧固件74可以是可将板固定于适当位置的任何其它紧固件。
接头84可允许板72相对于上边关节部分22的上面主体移动。在所示的实例中,接头84是一个铰链,其提供板72相对于上面主体沿纵向中心线58的方向移动。给板72提供自由度可使板72对椎弓根更容易放置,并且可以弥补板和椎弓根之间的任何空间。在一些实施方式中,在适当位置将板72固定于椎弓根,并且安全地使上关节部分22的椎间盘段26位于椎骨14的终板,在适当位置有效地锁住接头84。
通过提供与椎间隙S间隔开的连接位置,板72和接头84使修复器件20被固定于椎弓根,而不是椎体。因此,修复器件20被连接到脊柱中更强的骨头,这提供另外的支持。这可减低随时间紧固件松弛或摇晃的机会。这也减少当紧固件被置于非常靠近脊椎终板时可能出现的问题。这可以在椎体开始变得相对脆的患者中发现特别应用。
图8A和8B是在上和下椎骨14、16之间的修复器件20的侧视图。如所示,椎间盘段26可以位于沿上椎骨14的下表面,并且椎间盘段32可以位于下椎骨16的上表面。然而,本领域普通技术人员应该理解两个椎间盘段26、32不限于这样的排列;与本文阐述的相比,其可位于不同的位置和/或不同地成形。
图8A示出当脊柱在自然位置时的器件20,而图8B示出当脊柱在弯曲状态时的器件20。尽管没有显示,但是修复器件20也允许关节拉伸。参考图8B,但在弯曲状态时,上边关节部分22的后段28的运动制动器69与下边关节部分24的运动制动器66接触。因此,修复器件20的弯曲/拉伸和/或扭转关节范围被限制于运动制动器66和69所允许的量。图8A示出连接到基本中心位的修复器件20,其中孔70被排列在尾60的大约中部区域。当处与拉伸时,在一些实施方式中,关节范围被桥段30、36所限制,桥段30、36可作为运动制动器限制上边和下边关节部分22、24之间的关节。在所示的实例中,修复器件20的全部运动范围可以大约为45度。然而,运动范围与其相比可或多或少,根据通过运动制动器所控制的。
图9示出在下椎骨16上适当位置的修复器件20的俯视图。在图9中,显然地,可设置修复器件20以安置于盘间空间的一半上,而第二修复器件20可被安置于盘间空间的另一半上。因此,在一些实施方式中,完整的假体盘可包括一对修复器件20,一个用于左边,另一个用于右边,它们一起协作代替天然盘。应该是十分明显地,右和左修复器件20在结构和功能上可基本相似。
关节修复器件100的另一实施方式在图10-12中示出。关节修复器件100与前面描述的关节修复器件20具有很多相似特征。这里不再重复这些特征的详细描述。然而,应该理解前面描述的关于器件20的任何特征可被运用到器件100,反之亦然。
关节修复器件100包括上关节部分102和下关节部分104,每一个分别具有椎间盘段106、108,并且每一个分别具有后段110、112。代替前面描述的连接板72,修复器件100包括连接元件,如尾114,其从下关节部分104延伸,通过上关节部分102中的孔,以连接到上椎骨14。因此,在该实施方式中,下关节部分104连接上椎骨14。
健康的脊柱分配携带的载荷,以便大约80%的载荷被携带在椎骨的前区,大约20%的载荷被携带在椎间关节面上。在通过后路手术操作除去关节面后,椎骨的前区典型地携带全部100%的载荷。在图10-12的实施方式中,尾114将上椎骨14连接到下关节部分104,以便任何被施加载荷的百分比再仅仅被椎骨的前面部分承载,而且被后面部分承载。因此,通过在前面部分和后面部分之间分配所施加的载荷,修复器件100具有比传统修复器件更接近与天然脊柱相匹配的载荷分布。
而且,因为后路植入操作通常包括去除作为韧带和肌肉的连接位置的小面关节或突起,它们的去除可限制关节控制关节连接的范围的能力。因此,传统通过后路操作植入的修复器件提供关节接合,但其可在很大程度上不受控制。随着除去肌肉和韧带,修复的关节可变得松弛。本文公开的椎间修复器件可使关节连接缓冲,从而对脊柱提供更大的稳定性和更多的控制。
尾114包括下尾部分120、上尾部分122和柔性的缓冲器124。下尾部分120可相似于前面描述的尾60形成,并且可以是下关节部分104的整个部分,或者可选地,可以通过连接器,如接头、支架或其它体系,连接到下关节部分104。上尾部分122适合于连接到紧固件126。在所示的实例中,上尾部分122是直杆。然而,上尾部分122可以是直的或弯曲的,以对下关节部分104提供杠杆作用和期望的载荷分布。上和下尾部分122、120可由适合于修复器件100的任何材料形成。在一些实施方式中,上和下尾部分122、120由同种材料形成,而在其它实施方式中,它们可由不同材料形成。
柔性的缓冲器124可允许上和下尾部分122、120之间的相对移动。这种移动性能使上和下椎骨14、16在屈伸运动中移动,尽管下关节部分104被连接到上和下椎骨14、16两者之上。柔性的缓冲器124可由任何适合的生物相容性材料形成;在其它材料中,所述生物相容性材料包括例如弹性材料和聚合物。在所示的实例中,柔性的缓冲器124与上和下尾部分122、120共线。然而,在其它实施方式中,柔性的缓冲器124的直径和厚度可大于或小于上和下尾部分122、120的直径和厚度。在一些实例中,柔性的缓冲器124超模压在上和下尾部分122、120上。在其它实例中,上和下尾部分122、120可以通过能从上尾部分延伸到下尾部分的金属索——并且提供弹性垫以转移载荷——来固定在脊柱后部。在一个实施方式中,索可被固定在每一端,例如在上和下尾部分122、120内,并可限制伸展度的范围,而柔性的缓冲器124可控制弯曲的量。在其它实施方式中,不能固定该索以限制弯屈或伸展的范围,而仅仅是将各个尾部分固定在一起。
如在图10中所示,紧固件126可被设置以可调节地连接到椎骨14和上尾部分122。这里,紧固件126包括骨部分128和头部分130。骨部分128可包括螺纹,并且可被设置以本领域已知的方式连接到骨。在该示例性实施方式中,头部分130形成有U-型,其被设置接受上尾部分122。固定螺丝钉132可被钉入所述U-型,将上尾部分122固定在固定螺丝钉132和所述U-型的基底之间的适当位置。在所示的实例中,固定螺丝钉132包括外部螺纹,其与U型的内部螺纹相匹配。松开固定螺丝钉132放出尾114,其然后可被调节或处理到预期的位置。然后,拧紧固定螺丝钉132将尾114固定在适当位置。
紧固件126可被在基本上平行于修复器件100的纵轴134的方向上钉入椎骨。在一个实例中,紧固件126被钉入椎弓根,而在另一个实例中,紧固件被钉入椎体。
修复器件20、100可被植入椎骨14、16之间,如将在下面描述的。一般而言,如上面描述的,人造椎间修复器件20、100可被植入锥体,使用与已知的经椎间孔腰椎椎体间融合术(transforaminal lumbarinterbody fusion(TLIF))或后路椎间盘融合术(posterior lumbar interbodyfusion(PLIF))相似的经椎间孔方法(transforaminal approach)。PLIF方法通常是更普通的,并且依赖更多的进入脊椎间隙的行走根(traversingroot)和硬膜(dura)的缩回。TLIF方法典型地更间接,其需要更少的出口根(exiting root)的缩回,并且更少的硬膜外出血(epidural bleeding)以及更少的行走结构的缩回。也可能使用远外侧方法(far lateralapproach)进入间隙。在一些情况下,可能使用远外侧方法进入间隙而没有切除关节面。而且,已知通过腰肌的直接的外侧方法(direct lateralapproach)。该方法完全避免后神经元件。预期修复器件20、100的实施方式可使用任何这些普通的方法。
根据这些方法的至少一个,切口例如中线切口可在患者背部进行,一些或所有受侵袭的盘和周围的组织可通过孔移除。椎骨14的上终板表面可被碾磨、锉磨或其它方式切除,以与和上关节部分的骨接触面的轮廓相匹配,以便标准化在椎骨14的上终板表面上的压力分布和/或在骨向内生长前提供初始的固定。椎骨14的终板的准备可导致扁平表面,或者导致如袋、沟或与骨接触面38上相应特征匹配的其它轮廓的表面轮廓。椎骨16的下终板可被相似地制备为接受下关节部分至出口神经根和背根神经节允许的程度。在一些方法中,椎骨14、16的天然小面关节可被修剪或除去,以为关节部分的后段腾出空间。
然后,修复器件的上边和下边关节部分可被定向,以便尾延伸通过孔。然后,上边和下边关节部分可被同时引入经椎间孔开口,并且被置于上和下椎骨之间适当的脊椎间盘空间。
在一些过程中,上边和下边关节部分可被通过插管引入。如果该部件是模块的,那么修复器件可以是一次植入的部件,并且最后引入上边和下边关节部分的后段。
桥段可以在后面方向从盘间段上延伸和在后面方向从椎间隙S延伸。后段被置于椎间盘间隙的后面方向,以取代或补充天然小面关节的功能。
参考修复器件20,板72可绕其接头84旋转,以便其与骨接触。医师在具有扇形轮廓78的孔76中可选择适当的洞,以引入紧固件74。该选择可基于位置,医师相信该位置对于将紧固件74固定入骨是最理想的。可通过孔将洞钻入骨,并且紧固件74可被钉入该洞。应该注意,在一些实施方式中,板不与骨直接接触,而是可将间隔器、垫圈或缓冲器置于板和骨之间。
参考修复器件100,医师可选择适当的位置放置紧固件126,优选在允许尾114上的柔性的缓冲器124被置于紧固件126和椎间隙S之间的位置。可将洞钻入骨,并且可将紧固件126钉入该洞。然后,尾114可被固定于盘间隙S外的紧固件126。
当安装时,关节面42、46产生的球窝型关节可以是相对稳定的,并自身置于中心。前关节和后连接(通过尾和孔连接形成的)使修复器件20抵抗剪切力,特别是前-后的力。此外,由圆柱体14、16限定的绕纵向中心线的旋转运动可以被尾和孔连接中的限制,以及使用两个修复器件提供的联合限制所限制。
前关节和尾和孔连接的坚实并宽容的结构,允许在修复器件的安置中存在失调和轻微的不精确。例如,关节的球窝结构容忍两个部分之间的一定量的失调。尾和孔的相互作用也调节修复器件20、21之间的平行失调和/或前-后失调。在一些实施方式中,单一单侧修复器件可被植入,而在另一些实施方式中,形成右和左器件的两个器件可被植入。
在一些实施方式中,尾114由单一刚性部件和柔性缓冲器形成。例如,尾可以包括从关节部分延伸的下尾部分。然后,柔性的缓冲器可以从下部延伸并被固定在紧固件。因此,在这样的实施方式中,上尾部分可以从设计中除去。在又一实施方式中,尾部完全由柔性缓冲器形成,所以整个尾是柔性的。也考虑包括多个柔性部分和多个刚性部分的其它实施方式。
在一些实施方式中,上边和下边关节部分都包括具有至少一个柔性部分的尾。在这些实施方式中,尾延伸经过彼此,所以来自下关节部分的尾延伸连接到上椎骨,而来自上关节部分的尾延伸连接到下椎骨。可形成这些尾具有相似或不同水平的柔性,以提供期望的缓冲和载荷分布。上边和下边关节部分可以包括或可以不包括用于接收相对尾的孔。
相似地,在一些实施方式中,上边和下边关节部分都包含板。这些板可从关节部分的主体延伸,并且使每个关节部分被固定到各自的椎骨。每一板可具有一个或多个孔,其可以是扇形的,这为紧固件提供了一个以上的位置。应该注意,在任何实施方式中,板在除桥段以外的任何位置可被连接到关节部分的主体。例如,在一些实施方式中,板从后面部分延伸。
在一些实施方式中,修复器件包括具有柔性缓冲器的板和尾。在这些实施方式中的一些,板和尾可以使用相同的固定螺丝或者不同的固定螺丝。
尽管上面仅详细描述了一些示例性实施方式,但是本领域普通技术人员将很容易理解在示例性实施方式中许多改变是可能的,而没有本质上背离本公开内容的新的教导和优点。因此,所有这类变化和选择拟被包括在本发明的范围内,如在下面权利要求中所限定的。本领域普通技术人员应该也意识到这类改变和等价构建或方法没有背离本公开内容的精神和范围,他们可对本文进行各种变化、替代和选择而没有背离本公开内容的精神和范围。应该理解所有空间参考例如“水平的”、“垂直的”、“顶部”、“上部”、“下部”、“底部”、“左边”、“右边”、“头的”、“尾的”、“上面”和“下面”仅仅是为了说明的目的,并且在本公开的范围内可以改变。在权利要求书中,方法和功能项拟包括本文描述的、实施引用的功能的元件,并且不但包括结构等价物而且包括等价元件。
Claims (50)
1.修复器件,用于置于上椎骨和下椎骨之间限定的椎间隙,以提供所述上椎骨和下椎骨的关节运动,所述修复器件包括:
上关节部分,其被设置为至少部分置于所述椎间隙;
下关节部分,其被设置为至少部分置于所述椎间隙,并且被设置为与所述上关节部分协作以便提供所述上椎骨和下椎骨的关节运动;和
连接元件,其从所述上关节部分和下关节部分的一个起、在脊柱的通常方向延伸,所述连接元件被设置为固定到所述上和下椎骨的至少一个上,以便将所述上和下关节部分的一个至少部分牢固固定到适当位置。
2.权利要求1所述的修复器件,其中所述上边和下边关节部分每一个具有后段,其被设置排列在所述椎间隙后面的位置,所述连接元件从后面部分延伸。
3.权利要求1所述的修复器件,其中所述连接元件包括柔性部分。
4.权利要求3所述的修复器件,其中所述柔性部分被设置对所述关节提供缓冲。
5.权利要求4所述的修复器件,其中所述缓冲是在弯曲和延伸中都缓冲。
6.权利要求3所述的修复器件,其中所述连接元件包括刚性上部分。
7.权利要求6所述的修复器件,其中所述连接元件包括刚性下部分。
8.权利要求7所述的修复器件,其中所述柔性部分被排列在所述刚性上和下部分之间。
9.权利要求3所述的修复器件,其中所述柔性部分由弹性材料形成。
10.权利要求3所述的修复器件,其中所述柔性部分包括延伸通过那里的索。
11.权利要求1所述的修复器件,其中所述上边和下边关节部分的一个的另一个包括孔,孔至少部分绕所述连接元件延伸。
12.权利要求1所述的修复器件,包括紧固件,被设置以将所述连接元件固定于所述上和下椎骨的至少一个。
13.权利要求1所述的修复器件,其中所述紧固件可调节地连接到所述连接元件。
14.权利要求1所述的修复器件,其中所述紧固件可调节地连接到所述连接元件的刚性部分。
15.权利要求1所述的修复器件,其中所述连接元件被设置从下面之一延伸:
从所述上关节部分至所述下椎骨;和
从所述下关节部分至所述上椎骨。
16.权利要求1所述的修复器件,其中所述连接元件被设置为在多个可选择的位置接受紧固件。
17.权利要求1所述的修复器件,其中所述连接元件是刚性板。
18.权利要求1所述的修复器件,其中所述上边和下边关节部分的一个包括后面部分和桥部分,所述连接元件从所述桥部分延伸。
19.权利要求1所述的修复器件,其中所述连接元件通过接头被连接到所述上边和下边关节部分的一个。
20.权利要求19所述的修复器件,其中所述接头提供对所述连接元件的自由度。
21.权利要求19所述的修复器件,其中所述接头是铰链。
22.权利要求1所述的修复器件,其中所述连接元件包括被设置接受紧固件的至少一个孔。
23.权利要求22所述的修复器件,其中所述至少一个孔是扇形孔,并进一步包括设置被驱动通过所述扇形孔的紧固件。
24.权利要求1所述的修复器件,其中所述连接元件至少延伸至所述上或下椎骨的椎弓根。
25.权利要求1所述的修复器件,其中所述紧固件被设置基本上沿所述上边和下边关节部分的一个的中线排列。
26.保持运动的修复器件元件,用于置于上椎骨和下椎骨之间限定的椎间隙,所述修复器件包括:被设置为至少部分置于所述椎间隙的关节部分,所述关节部分被设置为相匹配的关节部分协作提供所述上和下椎骨的关节运动,所述关节部分包括主体和连接元件,
其中所述主体被设置为相对于所述上和下椎骨的一个而被固定,所述连接元件被设置为在所述椎间隙外面和与所述椎间隙隔开的位置固定于所述上和下椎骨的至少一个。
27.权利要求26所述的修复器件,其中所述连接元件包括孔。
28.权利要求27所述的修复器件,其中所述孔是扇形孔,所述假肢并进一步包括设置被驱动通过所述扇形孔的紧固件。
29.权利要求26所述的修复器件,其中所述连接元件被设置为在多个可选择的位置接受紧固件。
30.权利要求26所述的修复器件,其中所述连接元件是刚性板。
31.权利要求26所述的修复器件,其中所述上边和下边关节部分的一个包括后面部分和桥部分,所述连接元件从所述桥部分延伸。
32.权利要求26所述的修复器件,其中所述连接元件包括接头。
33.权利要求32所述的修复器件,其中所述接头连接所述连接元件和所述主体。
34.权利要求32所述的修复器件,其中所述接头提供对所述连接元件的自由度。
35.权利要求32所述的修复器件,其中所述接头是铰链。
36.权利要求26所述的修复器件,其中所述连接元件至少延伸至所述上或下椎骨的椎弓根。
37.权利要求26所述的修复器件,包括紧固件,所述紧固件被设置为连接到所述连接元件,并基本上沿所述上边和下边关节部分的一个的中线排列。
38.运动保持的修复器件元件,用于置于上椎骨和下椎骨之间限定的椎间隙,包括:被设置为至少部分置于所述椎间隙的关节部分,所述关节部分被设置为相匹配的关节部分协作提供所述上和下椎骨的关节运动,所述关节部分包括主体和柔性连接元件,其中所述主体被设置为相对于所述上和下椎骨的一个而被固定,所述柔性连接元件被设置为连接到所述上和下椎骨的另一个。
39.权利要求38所述的修复器件,其中所述柔性连接元件被设置为沿脊柱的总体方向延伸。
40.权利要求38所述的修复器件,其中所述柔性连接元件被设置为沿所述上和下椎骨的另一个的外部延伸。
41.权利要求38所述的修复器件,其中所述柔性连接元件被设置为排列于所述椎间隙后面的位置。
42.权利要求38所述的修复器件,其中所述柔性部分被设置为对关节运动提供缓冲。
43.权利要求42所述的修复器件,其中所述柔性部分被设置为在弯曲和延伸中都提供缓冲。
44.权利要求38所述的修复器件,其中所述柔性连接元件包括刚性上部分。
45.权利要求44所述的修复器件,其中所述柔性连接元件包括刚性下部分。
46.权利要求45所述的修复器件,其中所述柔性连接元件包括排列于所述上和下刚性部分之间的柔性部分。
47.权利要求38所述的修复器件,其中所述柔性连接元件至少部分由弹性材料形成。
48.权利要求38所述的修复器件,其中所述柔性连接元件包括延伸穿过那里的索。
49.修复器件,用于置于上椎骨和下椎骨之间限定的椎间隙,所述修复器件包括:
权利要求40所述的运动保持的修复器件元件作为第一关节部分;和
第二关节部分,其被设置与所述第一关节部分协作,以便给所述上和下椎骨提供关节运动,其中所述第二关节部分被设置为相对于所述上和下椎骨的另一个而被固定。
50.权利要求49所述的修复器件,进一步包括紧固件,所述紧固件被设置为连接所述柔性连接元件到所述上和下椎骨的另一个上。
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2006
- 2006-01-30 US US11/342,961 patent/US7635389B2/en active Active
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2007
- 2007-01-12 CN CNA2007800075097A patent/CN101394813A/zh active Pending
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- 2007-01-12 EP EP07762459A patent/EP1983943A1/en not_active Withdrawn
- 2007-01-12 AU AU2007208185A patent/AU2007208185A1/en not_active Abandoned
- 2007-01-12 KR KR1020087021154A patent/KR20080093141A/ko not_active Application Discontinuation
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CN105142576A (zh) * | 2013-03-15 | 2015-12-09 | 内奥斯外科公司 | 用于修复椎间盘的装置 |
CN105142576B (zh) * | 2013-03-15 | 2017-04-12 | 内奥斯外科公司 | 用于修复椎间盘的装置 |
Also Published As
Publication number | Publication date |
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WO2007087477A1 (en) | 2007-08-02 |
US20070191945A1 (en) | 2007-08-16 |
US7635389B2 (en) | 2009-12-22 |
JP2009525147A (ja) | 2009-07-09 |
EP1983943A1 (en) | 2008-10-29 |
KR20080093141A (ko) | 2008-10-20 |
AU2007208185A1 (en) | 2007-08-02 |
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