CN1551747A - 脊椎稳定组件 - Google Patents

脊椎稳定组件 Download PDF

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CN1551747A
CN1551747A CNA028175018A CN02817501A CN1551747A CN 1551747 A CN1551747 A CN 1551747A CN A028175018 A CNA028175018 A CN A028175018A CN 02817501 A CN02817501 A CN 02817501A CN 1551747 A CN1551747 A CN 1551747A
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implant
assembly
human body
vertebra
ligament
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CN100393286C (zh
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让・泰勒
让·泰勒
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    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
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Abstract

本发明涉及一种组件,该组件包括:一个缓冲后植入体(10),用于通过侧向通道位于两个被治疗的相邻椎骨(2、3)的骨板—脊椎连接处,而不切除上脊椎后韧带(5),所述植入体(10)有一个高度,当该植入体就位时,这个高度可以使上脊椎后韧带(5)恢复解剖学张力;和至少一个肌体间缓冲植入体(11),用于通过与解剖时使用的通道相同的后—侧通道插入到两个被治疗的椎骨(2、3)的椎板之间,所述植入体(11)有一个高度,该植入体就位时,这个高度可以恢复椎间盘(4)的解剖学高度,并且使共同的前韧带恢复解剖学张力。

Description

脊椎稳定组件
技术领域
本发明涉及一种脊椎、特别是腰椎的稳定组件。正如下面将要描述的,这种组件可以作为一种具有双重作用的辅助假体。
背景技术
已经知道,两个相邻椎骨,特别是腰部的椎骨的活动度取决于前侧的椎间盘和后侧的成对的小关节面(facettes articulaires)。
椎间盘和小关节面的位置保证扭转时在与脊柱垂直的平面中以及脊柱弯曲和延伸时在一个纵分面中自动限制运动。
椎间盘的形状、结构和高度使椎间盘具有保持脊柱前凸、缓冲和应力分布的补充功能。在后部,小关节面引导运动,并起着铰链的作用。
椎间盘的老化过程导致前后椎间盘——小关节面的这种平衡的紊乱。一般说来,椎间盘的退化先于小关节面的退化。椎间盘的萎缩和不稳定导致小关节面形成的后脊柱处应力部分转移,这会导致小关节面失去一致性以及韧带松弛。因此产生关节表面的损坏,而这又会导致具有机械和神经特征的各种症状。
为了治疗这些症状,已经考虑通过在两个有关脊椎的平台之间插入一个移植物来进行一前关节固定术(arthrodèse antérieur)。这个移植物大部分时间包含在一个叫做“融合笼(cage de fusion)”的刚性笼内。
但是,这种技术会保留转动的不稳定性,这种不稳定性会中期地破坏预期的镇痛结果,因此现在确定应该通过一个后关节固定术来完善前关节固定术。
这种类型的手术具有一些局限性和缺点。实际上,这种手术针对处于前期的严重症状,并且由于病人经常经历了一个病症变化比较缓慢的阶段,这种手术没有消除危险。另外,这种手术可能在相邻的关节处造成中期或长期的有害结果。
由于这个原因,一些叫做“non-fusion”的技术得到发展,这些技术关注早期治疗以及减轻椎间盘——小关节面的退化现象。
在椎间盘间隙方面,已经开发了目的在于代替髓核(nucleuspulposus)的不同缓冲植入体,其形状为成对的垫子或椭圆形或螺旋形的构件。
这些植入体的植入可以通过一个前入口进行,缺点是损伤共同的前椎骨韧带,或者通过一个后入口进行,缺点是由于植入物体的体积而导致不可忽视的骨质损失。
也已经考虑了注射一种能够就地聚合的胶体的技术,甚至使用形状为两个金属板的实心椎间盘修补体,金属板中加入缓冲材料,并且在相邻椎板的每一个处贴靠椎间盘。
这些技术在椎间盘退化并结合小关节面磨损和/或韧带松弛的治疗方面还不能完全令人满意。
还考虑了限制小关节面的关节间隙的设备。这种类型的设备包括一个编织的连续韧带,通过内茎式螺丝钉(vis pediculaires)的偏移位于脊椎骨的棘突之间或者沿着小关节面,以及/或者包括一个分开(distractant)的缓冲构件,该构件位于椎骨板—脊椎连接处,以减小小关节面的间隙,同时拉紧后面的囊—韧带构件。
已经证明,这种技术在上述治疗方面也不能令人满意。
发明内容
本发明的目的是克服这个基本的缺点,并提供一种稳定组件,用于稳定两相邻椎骨,所述相邻椎骨同时经受一椎间盘退化、并伴有韧带松弛以及可能有的小关节面磨损,另外,这个组件植入比较简单并且具有比较少的侵袭性(invasif)。
根据本发明,这个组件包括:
—一个缓冲的后植入体,适合于通过侧向通道放入到两个被治疗的相邻椎骨的椎骨板—脊椎结合处,而不切除上脊椎后韧带(ligamentpostérieur supra-épineux),这个后植入体有一个高度,当将其就位时,这个高度可以使上脊椎后韧带重新恢复解剖张力;和
—至少一个肌体间缓冲植入体,适合于通过与解剖时使用的相同后—侧通道插在两个被治疗椎骨的相邻椎板之间,这个植入体有一个高度,当植入体就位时,这个高度可以恢复椎间盘的解剖学高度,并且使共同的前韧带恢复解剖学张力。
因此,符合本发明的组件不仅可以在小关节面之间和椎板之间重新建立椎骨的解剖学间距,还可以通过保留共同的前韧带和上脊椎后韧带使这些韧带恢复解剖学张力。
这种恢复张力的作用是恢复这些韧带之间存在的解剖学韧带“平衡”,同时使椎间盘和小关节面恢复它们的解剖学功能,即椎间盘的缓冲功能和小关节面铰链功能和后平衡功能。
后植入体直接放在小关节面的后面,在脊柱间的韧带复合体处,并且能够经受压缩和拉伸的冲击。
肌体间植入体最好沿着椎板的周围尽可能向前就位。因此该植入体位于应力最大处。后植入体最大程度的远离可以更好地重新建立所述的前—后韧带的平衡。
因此,后植入体和肌体间植入体的功能是吸收脊柱向前和向后弯曲运动时产生的压缩和拉伸应力。当脊柱向前弯曲时,通过后植入体恢复功能张力的上脊椎后韧带保证它限制运动的解剖学功能,由于后植入体施加的辅助和控制,这种功能被优化和加强,因为逐渐拉伸限制了运动。同时,肌体间植入体帮助衰退的椎间盘吸收上脊椎体对下脊椎体施加的压缩应力,并缓解了所谓的“蠕变”现象,即椎间盘在一个压力作用下的下陷。肌体间植入体同时提供一个限制后面的软结构承受的拉伸作用的辅助限制。当脊柱向后弯曲时,通过肌体间植入体恢复功能张力的前椎骨韧带保证它逐渐限制运动的解剖学功能,拉伸缓冲植入体辅助并配备了这种功能。同时,后植入体被压缩,因此在小关节面的铰链和后平衡功能方面优化了小关节面的作用。
因此,每个植入体的作用与其它植入体的作用相结合。其中一个植入体的拉伸通过相互依赖的自我限制作用适应另一个植入体的压缩。
另外,首先使用一个唯一的通道可以大大简化手术,并且使本发明所述组件的侵袭性非常小。
还设有保持装置,用于保证就位的后植入体与棘突的连续性。这种保持装置可以包括后植入体的适当形状,形成接受棘突的相反凹槽,并且使后植入体具有“空竹”或“H”的形状,以及/或包括将后植入体固定在棘突上的装置,如两个独立的连接带或一些不限制植入体变形的刚性固定构件。
后植入体可以由一个单一构件构成,或者可以由两个组装的部分构成,每个部分被脊椎间间隙的一侧带动,并且在这个间隙处互相组装在一起。当这个后植入体的形状为“空竹”或“H”形并且由一个单一构件构成时,整个组件可以包括一个把这个植入体保持在一个变形状态的构件,在这个状态中,植入体包括的两个侧耳互相靠近,以便可以把植入体侧向插入到被治疗椎骨的棘突之间。
本发明的所述组件可以包括一个延伸到椎板的前侧区域的肌体间植入体,以便加强椎骨的侧向稳定性,并且可以辅助周向纤维环(annulusfibrosus périphérique);该植入体具有曲线形状,呈部分环形。
本发明所述组件还可以作为一个辅助周围纤维环的肌体间植入体的替代和补充包括一个肌体间植入体,用于替代和/或辅助所述核。因此这个植入体的整体形状可以是“菜豆”形或“Ω”形,并带有一个中间部分被两个在后侧上突起的侧叶延长的中间部分。该植入体也可以是球形。
最好至少一个肌体间植入体的横截面为三角形或梯形,并且以它的向前的最长侧边植入。
这样形成的植入体符合解剖学的椎间盘的斜率。
至少一个肌体间植入体可以包括保证将它保持在椎板之间的装置。特别是,这种装置包括一个与椎板相适应的肌体间植入体的形状,用于把这个肌体间植入体保持在这些平台之间。当肌体间植入体为球形时,它可以包括一个减少它的移动危险的赤道边缘。
后植入体可以包括一个缓冲材料如硅酮、聚氨酯、亲水聚合物、聚碳酸酯的核心,或一个具有形状记忆功能的金属构件和一个包围这个核心的外套。这个外套可以有效地保护这个核心或构件不受摩擦。外套可以由编织纤维形成。
肌体间植入体可以具有相同的结构。
这个肌体间植入体的就位可以通过一个设有一个活塞的引入导管来实现。这个植入体被压缩嵌入到这个引入管中,并且可以通过活塞被挤出。
引入管暂时压缩植入体。这种体积缩小,即植入体的体积缩小可以只有一个与解剖通道类似的手术通道,避免任何骨质的不稳定损失。通过穿过韧带的后—侧通道(LVCP)使管子进入到椎间盘的间隙中。一个半刚性的引导器引导并控制肌体间植入体的良好就位,然后穿过进入导管将半刚性引导器取出。
附图说明
为了更好地了解本发明,下面将参照所附示意图再次描述本发明,附图作为非限定性的例子表示本发明涉及组件的几个可能的实施例。
图1是两个要通过该组件治疗的病态椎骨的侧视图;
图2是按照一实施例的、该组件包括的一个后植入体的透视图;
图3是按照一实施例的、该组件可以包括的一个肌体间植入体的透视图;
图4和图5分别是通过一个为此设置的工具把肌体间植入体引入到椎骨体之间的过程中以及在这些椎骨体之间就位后的顶视图;
图6是两个植入体就位后两个椎骨的侧视图;
图7是一个按照另一实施例的肌体间植入体与图5类似的图;
图8是按照另一实施例的肌体间植入体的剖面图;
图9是该组件包括的符合另一实施例的后植入体和这个植入体要植入的两个椎骨的视图。
具体实施方式
图1表示两个椎骨2、3,它们的椎间盘4已经下陷。这种下陷导致上脊椎后韧带5和共同的前韧带6松弛、导致小关节面8受压迫过度紧张并可能使小关节面8产生病变、以及导致椎骨体7、9在前侧有互相接触的危险。
为了治疗这种症状,本发明提出一种两个植入体10、11共同作用的组件,即一个图2中看到的后植入体10和一个图3中看到的肌体间植入体11。
后植入体10由一个被一个编织外套包围的硅酮核心构成,编织外套由聚酯纤维制成,确保对核心的保护。该植入体有一个脊椎间的部分15和两对从部分15的两侧突起的侧耳16。
部分15的厚度略大于椎骨2、3前凸时脊椎间的解剖学间隙,使得当植入体10在骨板—脊椎连接处就位时所述部分15被棘突17轻微压缩。因此植入体10在这个位置可以使上脊椎后韧带5恢复解剖学张力。
部分15钻有两个横向管道20,如图6所示,这两个管道20用于接受两个独立的连接带21。连接带21用于使植入体10与棘突17紧密连接。每个连接带21可以由一个编织带构成,它的一端相嵌在一个插入弯针的端部,另一端包括一个环,在连接带21紧紧地锁定在相应的棘突17上之后,所述环相嵌在连接带21上。
与植入体10的总高度相比,侧耳16具有很大的高度,上侧耳和下侧耳的高度分别为总高度的33%和40%。同一对侧耳的两个侧耳16的内表面是倾斜的,向它们之间形成的凹陷的底部方向互相收敛。与植入体10的平均厚度相比,侧耳16有一个比较大的平均厚度,上侧耳和下侧耳的平均厚度分别为植入体10平均厚度的27%和30%。
这些侧耳16可以保证把植入体10保持在棘突17之间,而无论椎骨2、3的相对运动、特别是绕脊柱轴的转动如何,。
肌体间植入体11也由一个核心构成,该核心被一个聚酯纤维的编织外套包围,外套确保对核心的保护。植入体11具有曲线形状,为部分环形,并且它的尺寸使其就位后沿椎骨体7、9环形边缘的一个宽的前面部分延伸。当植入体11就位时,它的高度可以恢复椎间盘4的解剖学高度,并且使共同的前韧带6恢复解剖学张力。
实际使用时,首先通过侧向通道实现脊椎间韧带复合体的切除,然后将椎骨2、3分开,并将后植入体10放在棘突17之间,直接在关节小面8的后面,即在骨板—脊椎连接处。侧耳16的柔软性不会成为这种插入的障碍。两个位于植入体10插入一侧的侧耳16可以保持在互相翻折的位置,便于植入体10的插入。
然后每个连接带21穿过它所带有的环地嵌入,并且通过穿过这个环的滑动紧紧地锁定在对应棘突17的周围。然后把环相嵌在连接带21上,从而把这个连接带保持在锁定棘突17的位置上。
由于这种保持,植入体10既可以受压缩冲击,也可以受拉伸冲击。
植入体11通过在解剖时使用的同样的后——侧通道插入到两个椎骨2、3的椎板之间。如图4所示,植入体11的就位通过一个工具25实现,工具25包括一个设有一个活塞27和一个活塞杆28的引入管26。植入体11在压缩状态下嵌入到这个引入管中,并且在就位时通过活塞27从引入管中挤出。
植入体10和11可以在小关节面8之间和椎板之间共同重新建立椎骨2、3的解剖学间隙,但是还特别保留共同的前韧带6和上脊椎后韧带5,使这些韧带处于解剖学张力中。
因此,当脊柱向前弯曲时,上脊椎后韧带5可以重新保证它限制运动的解剖学功能。植入体10可以通过它的拉伸性帮助并控制这个韧带的动作。同时,植入体11恢复椎间盘4的缓冲功能,并且吸收上椎骨体7施加在下椎骨体9上的压缩应力,实现对周向纤维环(annulus fibrosuspériphérique)的辅助作用。因此植入体11还对上椎骨体7有逐渐的缓冲作用,防止椎骨体7、9之间接触的危险。
当脊柱向后弯曲时,脊椎前韧带6可以重新保证它的逐渐限制运动的解剖学功能。同时,植入体10被压缩,因此帮助小关节面8的铰链和后平衡的功能。
图7、8表示肌体间植入体11也可以代替一个图1-6所示的肌体间植入体11或作为它的补充用于替代和/或辅助所述核(nucléus)。如图7所示,它的整体形状可以是“菜豆”形或“Ω”形,并带有一个被两个突起在后侧上的侧叶延长的中间部分,或者如图8所示为球形,球形设有一个减少它的移动危险的赤道边缘。在第二种情况下,植入体11包括所述球形11a和一个形成所述边缘的环形11b,环形11b的开口的直径小于球形11a的直径,因此球形11a穿过这个开口带有变形地被嵌入,然后被固定在环形11b上。
图9表示后植入体10的形状可以为H形,并且包括一个把这个植入体的两个侧耳10a保持在一个变形状态的“卡子”30上,侧耳10a在变形状态下互相靠近。因此卡子30可以很方便地把植入体10侧向插入到被治疗的椎骨2、3的棘突17之间,直到未变形的侧耳贴靠棘突17,然后将卡子30取出,使侧耳10a展开,因此使植入体保持就位。
从上面可以看出,本发明对已有技术带来决定性的改进,并提供一种可以使同时经受椎间盘退化和韧带松弛以及小关节面磨损的椎骨的完全稳定功能的组件,这种组件植入比较简单,并且具有比较少的侵袭性。因此这种组件形成一种带有双重作用的辅助假体。
当然本发明不限于上面作为非限定例子描述的实施例,而是囊括进入所附权利要求确定的保护范围内的所有实施变型。

Claims (16)

1.稳定椎骨(2、3)特别是腰部椎骨的稳定组件,其特征在于,所述组件包括:
-一缓冲后植入体(10),适合于通过侧向通道放置到两个被治疗的相邻椎骨(2、3)的骨板-脊椎连接处,而不切除上脊椎后韧带(5),这个植入体(10)有一个高度,当该植入体就位时,这个高度可以使所述上脊椎后韧带(5)恢复解剖学张力;
-至少一肌体间缓冲植入体(11),适合于通过与解剖时使用的相同的后-侧通道插入到两个被治疗的椎骨(2、3)的椎板之间,这个植入体(11)有一个高度,当该植入体就位时,这个高度可以恢复椎间盘(4)的解剖学高度,并且使共同的前韧带(6)恢复解剖学张力。
2.如权利要求1所述的组件,其特征在于,所述组件包括保持装置(16、21),用于保证所述就位的后植入体(10)与棘突(17)的连续性。
3.如权利要求2所述的组件,其特征在于,所述保持装置包括一与所述后植入体(10)适当匹配的结构,并形成接受所述棘突(17)的相对的空孔部分。
4.如权利要求2或3所述的组件,其特征在于,所述保持装置包括把所述后植入体(10)固定在所述棘突(17)上的固定装置,例如两个独立的连接带(21)或一些不限制所述植入体(10)变形的刚性固定构件。
5.如权利要求1至4中任一项所述的组件,其特征在于,所述后植入体(10)由一单一构件构成,并且插入到所述椎骨(2、3)的棘突(17)之间。
6.如权利要求3至5中任一项所述的组件,其特征在于,所述后植入体的形状为“空竹”形或“H”形,并且为一个单一构件;而且所述组件包括一个把该后植入体保持在一变形状态的构件,在这个状态中,所述植入体包括的两个侧耳互相靠近,以便可以把所述植入体侧向插入到被治疗的棘突之间。
7.如权利要求1至4中任一项所述的组件,其特征在于,所述后植入体由两个组装的部分组成,其中的每一个部分被带到脊椎间的间隙的一侧,并且在这个间隙处互相组装在一起。
8.如权利要求1至7中任一项所述的组件,其特征在于,所述组件包括一肌体间植入体(11),适合于延伸在所述椎板的前侧区域处,以便加强所述椎骨(2、3)的侧向稳定性,并且可以辅助周向纤维环。
9.如权利要求8所述的组件,其特征在于,所述肌体间植入体(11)的形状为曲线形,呈部分环形。
10.如权利要求1至8中任一项所述的组件,其特征在于,所述组件包括一个用于替代和/或辅助所述核的肌体间植入体。
11.如权利要求10所述的组件,其特征在于,所述组件的总体形状为“菜豆”形、或“Ω”形——带有一个被两个在后侧上突起的侧叶延长的中间部分、或者为球形。
12.如权利要求1至11中任一项所述的组件,其特征在于,至少一个肌体间植入体的横截面为三角形或梯形,并且以它的朝向前侧的最大侧边植入。
13.如权利要求1至12中任一项所述的组件,其特征在于,至少一个肌体间植入体(11)包括保证把它保持在所述椎板之间的装置。
14.如权利要求13所述的组件,其特征在于,将所述肌体间植入体(11)保持在所述椎板之间的装置包括一适应所述椎板形状的肌体间植入体(11)的匹配结构,以便把这个肌体间植入体(11)保持在所述椎骨(2、3)之间。
15.如权利要求1至14中任一项所述的组件,其特征在于,所述后植入体(10)和/或肌体间植入体(11)包括一缓冲材料如硅酮、聚氨酯、亲水聚合物、聚碳酸酯的核心或一具有形状记忆功能的金属构件,和一包围这个核心的外套。
16.使如权利要求1至15中任一项所述肌体间植入体(11)就位的工具,其特征在于,所述工具包括一设有一活塞(27)的引入导管(26),所述植入体(11)在压缩状态下嵌入到这个引入管(26)中,并且可以通过所述活塞(27)从所述引入管中挤出。
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