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CN1522128A - 椎间盘假体和安装工具 - Google Patents

椎间盘假体和安装工具 Download PDF

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Publication number
CN1522128A
CN1522128A CNA028114353A CN02811435A CN1522128A CN 1522128 A CN1522128 A CN 1522128A CN A028114353 A CNA028114353 A CN A028114353A CN 02811435 A CN02811435 A CN 02811435A CN 1522128 A CN1522128 A CN 1522128A
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CN
China
Prior art keywords
kernel
prosthese
plate
load
bearing surface
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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
Application number
CNA028114353A
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English (en)
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CN100401996C (zh
Inventor
�ſˡ�����
雅克·博兰
若埃尔·德莱克林
米夏埃尔·奥尼穆斯
̩
埃尔韦·沙泰涅
热罗姆·阿兰
F����̩��
让-保罗·F·斯泰布
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LDR Medical SAS
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LDR Medical SAS
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Publication of CN100401996C publication Critical patent/CN100401996C/zh
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Abstract

本发明关于了一个替代纤维软骨盘的椎间盘假体，保证各脊椎椎骨或脊椎端之间的连接。对假体的内核(2)提供一个移动或转动挡块，或者在与椎骨接触的板(1，3)之间引入一个角度修正，或者这些特性的组合，本发明增加了这种假体的稳定性。这种挡块由内核之外的部分(6，20)得到，并且采用垂直于它们接触方向的接触表面。与内核承载表面(21，23)之间角度(a3)引入的这种角度修正措施一起，这种挡块容许更好的稳定性。

Description

椎间盘假体和安装工具
本发明关于一个替代纤维软骨盘的椎间盘假体，保证各脊椎椎骨或脊椎端之间的连接。
椎间盘由一个可变形但不可压缩的单元形成，称为“柔内核”，包含约80％的水，被几个弹性纤维层包围，集中来保持内核，吸收作用到整个盘上的力和稳定活节接合。由于随着冲击、感染、受力过大或仅由于过长时间而引起的压缩、位移或磨损，这些单元往往可能破碎或损伤。
这种关节单元的破碎可能引起病人的强烈疼痛和活动受到明显约束。除了堵塞有缺陷关节和可能完全去除受损的椎间盘的外科手术外，近二十多年来的医疗途径是用手术以一个功能假体替代有缺陷的椎间盘。但是，采用这种假体需要一个不太笨重的组件，它支承足够的力，或者具有长期坚固性。另外，巨大而剧烈疼痛已经影响到病人的舒适性，使得希望设置一个假体，最可靠地复现自然的活动能力，同时对有时已受损的脊椎保证最好的稳定能力。
所以采用这种假体主要取决于稳定性，它容许脊椎在活动时与在静力时或长期不变位置时一样。
已经提出了具有可压缩材料基的各种假体，目的在于复现自然活动的运动学特性，同时复现其各部分和它们的形状或塑性特征，如在专利FR 124 815中描述，它提出一个用纺织材料增强合成橡胶材料制成的椎间盘。这些组件存在寿命通常太受限制的缺点，并且也受到实际上由于这个弹性造成的缺陷。事实上，因为假体完全可压缩，相对于假体放置其中的椎骨，可产生假体的逐渐滑动，这往往导致假体脱离其支座。附加的固定销不能充分改善这个问题，因为假体材料可压缩性容许的微小活动也包括一个垂直分量，它很容易在每次活动中使得销脱离它们的支座。
在不依靠材料变形的假体中，专利DE 30 23 353描述了一种经常采用的假体类型，它由一个形状为双凸透镜的内核形成，在两个板之间形成活节接合，每个板在其中心具有一个形状与内核大致互补的腔，并且在其周边具有一个限制这个内核的肩部。与采用较大接触面积的更受限制的球套接头相比，这种设置具有优点，大大减少了磨损。
为了在一侧各板相互倾斜，在上述一侧的内核边上由板的内腔使板作活节接合，但由于转动运动，在另一侧使它们边的离开程度大于静止的位置。这个分离趋向脱离它们支承的椎骨板，在刚固定板的位置上损伤椎骨的表面，并且还容许逐渐移动，存在完全弹出假体的风险。
在专利FR 2 659 226中描述的另一类假体包括一个具有凹面的上板，它在球段形式的内核上滑动，这个内核固定在下板的腔内。在这种情形下，从板空间的观点看，转动比较满意，但上板在中心位于假体外的球上滑动也引起横向位移，它对运动学特性和对附近身体组织有害。
在专利FR 2 730 159中提出一个办法是形式为一个具有两个球面的内核，球面沿着相同的方向，并且具有不同的半径。具有圆柱外形的内核在属于下板的凸面上滑动，本身在顶上具有一个凸面，上板在凸面上滑动。由于内核可以水平运动，当板接近另一侧时内核处于从一侧离开的位置。但是，这个装置缺点为具有内核完全弹出假体外的风险，这个缺点在专利DE 30 23 353描述的组件中也存在。
为了限制内核弹出的风险，专利WO 00 53 127以及US 5 401 269和US 4 759 766提出了提供一个以不同方式产生的移动挡块。
在某些变型中，公布了一个为凸块形式的移动挡块，从内核的接触表面突出并且可在板的凹口中活动，或者相反。所以这种内部挡块类型位于内核和板之间的接触面或支承面内部，因此显著减少了可用表面。支承表面的减少增加了材料承受的应力，从而增加了磨损或蠕变应变或超过弹性极限的风险。支承表面和容纳挡块的凹口之间的区别也会引起如下风险：使被支承在上面的零件留有痕迹和受损伤。
在某些情形中，这种中心挡块为非圆形，在一定程度上限制了内核相对于设有挡块的板的转动。但是，这种非圆形形成的附加约束也限制了支承的可用表面。另外，这种形状的棱角本身形成了易碎区，它对这种挡块的转动作用仅保证低的坚固性。
在其他的变型中，从内核突出一个环并且在两板之间的空间中包围着内核。在环的外部，在沿着脊椎轴线的一定高度上，这个环向着每个板变宽，它形成了两个内部边界，可以支承在上述板接触表面的外部边界上。但是，这种外周边挡块类型存在某些缺点，特别是由于阻碍引起的缺点。
事实上，这种环的形式具有显著的垂直阻碍(沿着脊椎轴线)，板的接触表面也必须具有一定的高度才能够挡住这个环的移动。另外，这类挡块的周边形状也占有显著的径向空间，特别是在脊椎具有最小宽度的截面中，如径向平面中。如果在椎间盘空间中可用的空间受限制，这个环占有了可能对假体的其余部分有用的空间，限制了根据运动学特性的效果或可靠性。
另外，这种外周边挡块的类型需要采用双凸形状的内核，以容许对板的接触表面提供足够的高度来形成对这个挡块有用的外边界。所以，对具有一个或两个凹面的内核难以产生这种挡块类型，而这种内核形式可把假体的运动学特性做得对病人使用更舒适。
在内核和板之间的接触表面为非圆情形时，这种环也能够限制内核相对于板的转动间隙，例如依靠两个同心和不同半径椭圆的周边接触。但是，这种接触是根据相互支承表面之间的非常紧密角度实现的，它使得这种限制的位置不十分精确，并且增加了磨损或夹紧阻塞的风险。另外，由这种运动学特性容许的转动间隙直接取决于移动容许的间隙，在假体设计时不能独立于后者作选择。
本发明的一个目的是提出一种假体，依靠组成它的零件的相对位置的更大精度和坚固性，使得脊椎有更好的稳定性。
按照权利要求1的一个椎骨假体组件达到了这个目的。
另外，为了保证在安装这种假体之后脊椎的稳定性，不同病理造成脊椎承受的损伤导致决定安装一个假体，有时重建由脊椎弹性不再能提供的稳定性或姿势是有用的。根据病人的病理和病史，然后可以指示在锥骨间空间的构形中引入一定的角度修正，例如在脊椎前凸或后凸的情形中。
现有某些类型的假体采用改变一个板的厚度来引入这种修正。但是这种修正并不总是稳定的，特别是因为在活动时内核在板上的支承位置变化太大。
因此本发明的另一个目的是提出一个假体，依靠重建适于假体产生的运动学特性的姿势，使得假体具有更好的稳定性。
采用按照权利要求6的锥骨间假体组件达到了这个目的。
本发明的补充扩展在相关的权利要求中描述。
阅读参照附图的描述，本发明及其特征和优点将会更明显，其中：
图1表示了本发明假体的分解透视图，为一个包括凸下板和提供中心和环形挡块的型式；
图2表示了本发明假体组件的分解剖视图，为同样的型式；
图3表示了本发明假体组件的分解剖视图，为一个包括一个具平下表面的内核和具有环形挡块的下板的变型；
图4表示了本发明假体组件的分解侧剖视图，为一个包括具凹下表面的内核、附加块和具环形挡块的下板的变型；
图6a表示了本发明假体组件的侧剖视图，为一个具有中心、环形和倾斜挡块的变型，处于最大倾斜位置；
图6b表示了先前技术假体的侧剖视图，其中内核具有固定的位置；
图6c表示了先前技术假体的侧剖视图，其中内核可活动，并且在最大倾斜位置的作用力下受载弹出；
图5表示了一个变型的假体组件分解侧剖视图，包括一个容许露出中心挡块的附加块和一个具有环形挡块的平下板；
图7表示了一个变型的假体组件侧剖视图，没有环形挡块，其中中心挡块具有燕尾形状的垂直截面，处于最大倾斜位置；
图8a和8b表示了本发明假体组件的侧剖视图，按照一个具有倾斜轴线的变型，分别在单下板和有附加块的情形下，包括一个环形挡块和一个与支承内核的接触表面结合的中心挡块；
图8c表示了本发明假体组件径向平面中的侧剖视图，按照一个具有修正内核的变型，内核具有两个接触表面不平行的面；
图9a表示了本发明假体组件的透视图，按照一个在内核外具有两个挡块的变型，挡块被夹持在与下板成整体的立柱之间的一个凹区中；
图9b表示了本发明假体组件的透视图，按照一个在内核外具有两个挡块的变型，每个挡块在其两臂之间夹持了与下板成整体的一个立柱；
图10表示了本发明一个装置的透视图，用于安装这种假体；
图11表示了本发明一个装置的透视图，用于插入这种假体，处于在两个椎骨之间沿横向引入假体时的位置；
图12按照本发明的一个实施例，表示了一个具有插入导座的装配工具透视图；
图13表示了本发明假体的透视图，位于本发明插入导座的入口；
图14按照本发明一个实施例，表示了一个器件的透视图，此时假体准备压入椎间盘空间。
图6b表示了按照专利FR 2 659 226公布的先前技术的假体，它包括一个在内核(2AA)上滑动的凹上板(3AA)，内核具有一个球形上帽(23AA)，本身固定在下板(1AA)的一个凹区中；处于水平位置和最大倾斜位置。由于提供与内核接触面的球的中心(csAA)位于这个上板(3AA)之外，其倾斜结合了显著的横向位移。这个位移断开了脊椎垂直外形的连续性，妨碍整个活动功能，有风险立即或长期损伤椎骨周围的组织，如韧带和脊髓。
图6c表示了按照专利FR 2 730 159公布的先前技术的假体，它包括一个可活动内核，内核具有两个沿相同方向定位的球面，在两个板之间可以横向移动和可以容许倾斜而没有横向位移。但是，在极限位置上，上板球面的最远边界仅把内核保持在外侧上。因为这个边界本身已经升高，这有很大的风险：太高的垂直压力或水平附加力使内核向假体外部弹出，引起强烈的疼痛和有风险立即损伤脊椎周围的组织，如韧带或脊髓。
在图6a表示的一个实施例中，本发明的一个假体包括一个下板(1)，它环绕一个内核(2)与一个上板(3)成活节接合，内核在两面具有相同方向的两个球形滑动表面。内核(2)的下表面(21)为凹形，并且在设在下板(1)上面的一个互补凸面(12)(称为内面)上滑动。上表面(23)为凸形，并且在设在上板(3)下面的一个互补凹面(32)(称为内面)上滑动。在这个实施例中，内核(2)下接触面(21)的半径大于其凸上表面(23)的半径，提供其两个接触面的球的中心位于这两个表面的同一对称轴线(d2)上。在它们的侧面，两个板具有接触面(12，32)，其对称轴(d12，d32)垂直于它们的外面(10，30)。由于在上滑动表面上环绕其中心(cs)转动，内核沿一个方向的水平位移部分被内核在其下滑动表面上环绕其中心(ci)的转动(它引入内核(2)的水平位移，因而引入上滑动表面中心(cs)的水平位移)所补偿。确定提供这些滑动表面(12，21，23，32)的两个球的半径，在板倾斜时作相互比较，从而修正板的横向位移。在一个实施例中，可以选择这些滑动表面(12，21，23，32)的半径，使得板的活动减小到一个倾斜角度，相应有一个可能的垂直位移，但上板相对于下板没有水平位移。
为了在倾斜位置作用力时避免内核(2)弹出的风险，用一个中心挡块保持内核在其间隙中，例如挡块由一个圆柱块(4)形成，从下板凸面突出，与设在内核下凹面的接触面(21)中心上的一个凹口(22)边配合。
在一个实施例(图6a)中，下板在其上面还具有一个近似圆柱形空腔(11)，其中边(112)从与内核(2)的接触面(12)突出，并且与这个内核的近似圆柱形周边(20)配合，保证环形挡块对它的作用，同时限制它朝着提供它的接触面(12)之外的活动。
在一个实施例(图6a)中，板的内表面在滑动表面之外的部分(113，331)上，具有能够在它们之间配合的形式，以挡住板相互倾斜在规定角度(a1)上。
在图7中表示的一个实施例中，挡块(4)设在下板(1)的凸面(12)上，并且具有近似倒锥形状，也就是说，与提供它的表面(12)对着的一端(42)上截面较大。凹口(22)的内表面(224)具有一个切口形状，当内核处于靠在这个挡块(4)的最远位置时，凹口(22)的内表面(224)与挡块(4)的外表面(40)配合来限制内核的升高。
例如按照与材料强度、磨损或追求的运动学特性相关的准则，可以确定涉及挡块机构的不同形状和尺寸，例如，外部(图9a和9b)、环形、中心或倾斜，从而协调不同零件达到阻挡的次序。例如，可以确定这些形状和尺寸，使得各零件在同一活动阶段达到阻挡，例如由下板(1)和上板(3)之间的倾斜角度来确定。
在图7和8a所示的实施例中，很少或完全没有采用环形挡块作用，它容许减少假体的垂直阻碍。
在图3所示的实施例中，内核(2)的下表面(21a)可以近似为平的，然后在也近似为平的下板(1)接触表面(12a)上滑动。在这个实施例中，下板接触表面(12a)的平面度容许这个板的边(112)从这个表面突出，特别有效地起到环形挡块的作用。所以，可以设法不用中心挡块，从而增加了下板和内核之间的公共接触表面，它在一方面减少了各零件的磨损，另一方面减少了由于设置凹口轮廓(22，图6a)使板面留有痕迹的风险，在其他实施例中凹口容纳了中心挡块(4，图6a)。
在图4表示的实施例中，下板(1)在其上面具有一个近似圆柱形的空腔(11)，它的平底(15)容纳一个称为块(5)的中间件。这个零件例如被空腔边(112)固定在空腔(11)中，并且在其上面具有一个凸表面(52)，内核的下凹表面(21)在它上面滑动。这个实施例具有例如内核在其上面滑动的凸面(52)，容许更容易和更便宜地得到运动流动性所需的良好表面质量和假体的耐久性。它还容许几种模型设有不同形状和质量的块(5)，根据对同一下板模型的各个用途，可在外科手术之前或当时进行选择。
在图5表示的实施例中，下板(1)在近似圆柱形的空腔(11)中容纳一个块(5)，块具有一个垂直穿孔，与下板成整体的挡块(4)穿过它。在其上表面，这个块支承一个凸面(52)，内核(2)和上板堆放在它上面。
作为一个变型，挡块(4)可以在块(5)的凸接触面上与块成整体(图8b)。
为了在静止状态下得到两个椎骨之间相对位置的修正效果，可以产生一个假体变型，其中一个或几个零件的接触面(12，15，52，21，23，32)或支承面(10，30)的对称轴线不重合。然后在两个板上沿着垂直其外表面(10，30)方向由椎骨施加的压力(F)将倾向于引入和连续保持板间的一个不为零的倾角(a5，a3，图8a，8b和8c)，例如在脊椎前凸情形中。
在图8a中表示了这种变型的一个实施例，其中下板(1)接触面(12)的对称轴线(d12)与上述下板外表面垂直方向(d10)形成一个确定的角度(a4)，而上板(3)内接触面(32)的对称轴线(d32)垂直于上述上板(3)的外表面(30)。上板(3)的下接触面具有一条对称轴线，平行于上述上板(3)外面支承面(30)的垂直方向。
在按照图8b表示的相同原理的另一个变型中，采用的假体组件包括提供一个块(5)的下板(1)，块的上接触面(52)具有一条对称轴线(d52)，与垂直于下面(51)的方向(d51)形成一个确定的角度(a4)。下板(1)和上板(3)的内接触面(15，32)具有垂直于它们相关外面支承面(10，30)的对称轴线。因此，在外科手术时，可以根据所希望的修正程度，在几个具有不同倾角的块(5)之间进行选择。可以用任何已知的方式(未表示)，如在块(5)和提供它的下板(1)之间的楔、槽或相补不平形状，环绕垂直于下板(1)的轴线把块(5)保持固定。
在按照相同原理的另一个变型中，如图8c所示，内核(2)具有两个接触面(21，23)，其对称轴线(d21，d23)在它们之间形成一个确定的角度(a2)。下板(1)和上板(3)的内接触面(12，32)具有垂直于它们相关外面支承面(10，30)的对称轴线。然后依靠上述内核的一个转动阻挡机构(在图8c中未表示，这种机构在以下描述(图9a和9b))，由内核引入的角度修正(a3)可以沿着相对于病人身体所希望的方向保持不变。
在一个实施例中，本发明假体具有一个外部阻挡机构，位于内核(2)接触面的周边之外。
在图9a所示的一个变型中，这个机构由两个突出部分(6)形成，它们沿相反的方向从内核(2)周边的圆柱形外表面突出。每个突出部分夹持在一个凹区(162)中，凹区被与下板(1)成整体的两个立柱(161)限定。这些立柱与突出部分(6)配合，或与内核周边表面(20)配合，或者与两者均配合，以限制这个内核在转动时平行于上述板的移动。凹区足够大到容许内核作假体运动学特性所需的微小运动，同时足够窄到使得这个内核和下板在某个位置上，例如在脊椎最大倾斜位置上靠近。然后内核(2)的突出部分(6)或周边表面(20)与下板立柱(161)配合来夹持上述内核并避免任何横向弹出。
立柱(161)在端部比在底部具有更大截面，因此限制了内核的升高。
在按照相同原理和图9b所示的另一个工作变型中，这个机构由两个突出部分(6)形成，它们沿相反的方向从内核(2)周边的圆柱形外表面突出。每个突出部分具有两个臂，限定了一个凹区(66)，它夹持一个与下板(1)成整体的立柱(163)。立柱(163)在端部比在底部具有更大截面。
这些挡块实施例(图9a和9b)可以容许去除中心挡块，因此增加了接触表面，减少了磨损。这些挡块类型(6)还特别有用，因为限制了内核环绕近似平行于脊椎轴线的轴线的转动。事实上，这个限制使得可能采用一个修正内核，其中各接触表面具有不平行的对称轴线，同时沿着一个相对于病人身体不变的方向保持它们的修正。
在图6a所示的实施例中，下板(1)和上板(3)容纳了把锥骨固定在其外表面上的装置，设计成把假体固定在脊椎的各椎骨或相邻部分之间。这些固定装置可以是销(8)或楔，在离开提供它们的板的一端具有小的截面。然后在其中安装假体的椎骨(V)材料中冲孔，例如在保持椎骨分开的工具退出时韧带施加的压力作用下，嵌接或压接这些销。把销打入椎骨(V，图6a)材料中，防止假体从其原位滑出。
在图1所示实施例中，板(1，3)具有一个或几个不平形状，如缺口(7)或穿孔(未表示)，它们能够卡住一个抓紧工具，以便在需要时从其原位取出假体。下板(1)具有一个提供中心挡块(4)的凸上接触表面(12)和一个具有形成环形挡块的边(112)的空腔。
在图10所示的实施例中，本发明的一个插入装置由称为插入导座的一个零件(9)形成，它具有截面近似为矩形的内通道(90)，假体(P)可在其中滑动。这个通道(90)由两个截面形状为“U”的半导座(91，92)形成，它们相反设置和相互配合。在一端，导座(9)具有一个或两个沿其纵轴(d9)突出的称为支承块或支承边(910，920)的部分。这些支承块(910，920)形成了通道壁的延伸部分，称为垂直壁，它们形成了通道(90)矩形截面的短侧壁。
在图10和11所示的应用方法中，按照以下步骤进行本发明假体组件的安装：
-用已知的工具，例如脱位工具分开椎骨；
-在脱位工具附近滑进插入导座(9)，从而在椎骨(V)之间引入支承边(910，920)；
-松开和抽出脱位工具，由插入导座的支承边保持椎骨分开；
-引入准备安装到通道中的假体，并且滑到靠近脊椎；
-根据椎骨之间现有的空间形态调整假体的倾斜程度，按照一个相应的角度(a9)分开通道的两个部分(91，92)以协助这个调整；
-把假体推入通道的内部，在椎骨间空间中定位；
-把通道的支承块(910，920)抽到椎骨间空间之外，把用于固定椎骨(V)的块压接到椎骨中。
在图12a到14的实施例中，本发明用于安装假体的器件包括一个插入导座(93)，它设有一个内通道(90)。这个通道(90)具有近似矩形的截面，或者形状与假体外部轮廓大致相补。在近似平行于板(1，3)外表面的位置中和沿着它移动时，这个内通道(90)的尺寸和形状适于假体通过和从其一端引导到另一端。根据各个用途，插入导座(93)的通道(90)可以在对着假体板的壁上包括凹口。这种凹口能使设在假体板上的固定装置(8，81)通过，同时精确地在通道中引导假体。在这里所示的实施例中，这些凹口具有沿着轴线(d9)的槽(934，936)形，槽设在对着板(1，3)的通道内壁上。
垂直于假体板，即位于包含脊椎轴线平面内的通道(90)壁(931，932)在称为工作端的一端，沿着这个通道轴线(d9)延伸一个确定的距离，从而相对上述通道平行于假体板的壁向外突出。因此由于这些延伸壁形成突出部分或支承边，可以插入椎骨间的空间，保持板与包围这个空间的两个椎骨分开。
确定这些支承边(931，932)的高度，从而保持适当的空间，以容许按照所提供的固定方法，引入假体及其固定装置(8，81)。如果在自由引入空间之前由销套(8)或楔(81)形成固定装置，则支承边将足够高，以容许这些销套或楔的高度通过。如果固定装置由楔形成，楔需要从椎骨板表面中一个空心沟槽或侧向开孔穿过这些板，则这些支承边的高度可以足够低，以容许假体高度而不是楔的高度通过。
在用外科手术安装这种假体时，外科医生开始取出椎间盘或其碎片，然后采用脱位工具增加需要容纳假体的椎骨之间现有的盘空间。这种工具往往用一个细长手柄形成，一端有一个平的部分。在椎骨之间引入这个平端，然后做出转动，以增加椎骨的分离。
在本发明的器件中，一旦脱位工具位于椎骨之间，插入导座(93)的内通道(90)被设置成能够在这种脱位工具附近穿过。一旦在脱位工具周围时靠近脊椎，推入插入导座，从而把它的边(931，932)引入在椎骨之间，位于近似平行于脊椎的平面中。使脱位工具在插入导座的通道(90)中滑动，然后可以从脊椎取出脱位工具，而支承边的高度在椎骨之间保持足够的高度，以容许假体的安装。在这里所示的实施例中，插入导座(93)具有与一个导座装配工具(94)相互锁定的装置，导座装配工具用于使导座靠近脊椎和有助于它的安装。这个导座装配工具(94)还可用于取出插入导座及其支承边，以及一旦假体定位时，使椎骨固紧在假体上。
这种导座装配工具(94)在图12a和12b中说明。这个工具(94)由两个细长管(941，946)组成，用位于这个工具一端(称为装配端)的装置(945)相互活节接合。这两个细长管在与装配端相反的一端上，每个设有用于插入导座(93)的锁定装置。这个锁定装置例如可在每个管(941，946)上包括一个钩(942，947)，钩的开口位置对着另一个管。当导座装配工具(94)接近插入导座(93)时，在其活节接合附近把管相互靠紧，可以使每个钩(942，947)紧密包围从插入导座每个槽(933，935)上突出的“T”形舌片(934，936)。在每个管(941，943)内，沿着管轴有一个杆(943，948)，它可以依靠包括螺旋轮(944，949)的螺旋装置相对于管纵向移动。旋转这些螺旋轮使杆沿着管前进，然后与螺旋轮对着的杆端靠到并阻挡钩(942，947)(钩设在容纳这个杆的管上)内的插入导座(93)舌片(934，936)。因此这个阻挡作用可以充分稳定地把导座锁定到导座装配工具上，使得可以在脊椎上的脱位工具附近定位上述导座。
锁定插入导座(93)或设在上述插入导座上其他部分的这些装置(934，936)还可以把一个接近装置(95)引导和锁定到这个插入导座上。这个接近装置(95)包括用于定位假体的装置，设置这个定位装置来定位和保持被装配假体在相对于这个接近装置(95)的确定位置中，即使没有插入导座(93)时也如此。在接近装置上定位假体可以相互锁定接近装置和插入导座来把假体放在这样一个位置：它可以易于从上述接近装置移到插入导座(93)的内槽(90)中。因此，可以与其他操作独立地在接近装置(95)中准备假体。然后可以把插入导座安装在没有预先被假体占有的脊椎上，然后方便和快速地把这个假体插进插入导座(93)，而后者已经处于靠在脊椎的位置中。
如在图14中很好说明，这个接近装置(95)包括了用活节接合件(955)相互连接的两个轴(951，952)，从而把假体(P)夹紧在两个展平的部分之间，保证假体相对于这个接近装置的确定位置。与活节接合件对着的这些轴端包括锁定装置(953，954)，它们能够与插入导座(93)的锁定装置(934，936)配合，保证接近装置(95)相对于插入导座(93)的确定位置，以及装配的一定稳定性。在每个轴(951，952)端，这些锁定装置(953，954)可以特别包括一个凹口，其中两个臂包围在插入导座的槽(933，935)外面，同时在上述插入导座“T”形舌片(934，936)的上条之下滑动。
一旦已安装的插入导座(93)替代了脱位工具以及接近装置(95)锁定到这个导座上，则假体处于相对于脊椎的稳定位置，可以插进插入导座中，然后滑动到椎间盘空间。这里可借助于压紧装置或压紧器(96)达到这个移动，压紧器包括一个能够压住被装配假体的压紧端，分配在两个板上而不与内核接触。这个压紧器包括一个中央细长件(960)，它在活节接合端(955)上插入设在接近装置(95)上的“U”形开口的引导装置中。这个压紧器包括称为装配端或敲击端的另一端(962)，它可以用手或者任何已知工具或设备作用一个连续压力或重复冲击。然后这种沿着通道(90)轴线(d9)在压紧器装配端(962)上的作用将被在假体上的一端(961)响应，从而使假体滑进插入导座(93)的通道(90)，然后插入或压紧在椎骨之间的空间中。
在这里描述的本发明所有假体组件中，需要理解“下板”(表示在图的底部和编号1)和“上板”(表示在图的顶部和编号3)的区别完全是习惯，组件能够用于不同的位置，甚至与下板向着脊椎底部的位置相反。
因此，本发明提出了一个椎间盘假体组件，包括至少三个部分，这些部分包括一个称为下板的板(1)和称为上板的板(3)，环绕着至少一个称为内核(2)的中间部分产生一个在上述零件承载表面(12，15，21，23，32)之间支承和滑动的活节接合，这些零件之一包括至少一个突出部分或不平形状，与至少另一个上述零件的形状配合来形成一个挡块，限制内核活动的可能性，其特征在于：这种挡块功能采用至少一个在承载表面之外的挡块，包括从至少一个板(1)上突出的至少一个部分(161，163)，位于上述板承载表面(12，15)之外和包括一个朝着假体内部的面，这个面与位于内核承载表面(21，23)之外的内核(2)周边部分(6)配合，其中表面朝着内核的外部，在近似垂直于脊椎的平面内，限制内核的移动或转动或其两者。
按照一个特定方面，与下板(1)和上板(3)接触的内核(2)承载表面(21，21a，23)具有对称轴线(分别为d21，d23)，它们之间形成一个不为零的确定角度(a2)，使得施加在两个板(1，3)上沿着垂直其外表面方向的压力(F)引入这些板相互倾斜的一个角度(a3)。
按照一个特定方面，在由挡块表面相互支承的零件(6，161，163)之间的接触，使得这个外挡块限制了内核(2)相对于至少一个板(1)的转动，这个支承沿着近似平行于每个挡块表面法线的方向。
按照一个特定方面，外挡块包括一个从内核(2)上突出的舌片(6)，依靠限制这个舌片(6)在由立柱(161)限定的一个凹区(162)中，立柱从上述板(1)内面突出，或者依靠一个把这个舌片分成两个臂的凹区(66)，臂包围着从上述板(1)内面突出的一个立柱(163)，舌片与板之一(1)配合，这里板内面定义为向着内核一侧的面。
按照一个特定的方面，至少一个立柱(161，161，163)端部具有比它底部大的截面，这个增大的立柱与内核(2)外挡块舌片(6)的形状配合，相对于提供这个立柱的板(1)，限制了上述内核的升高。
按照同样的精神，本发明还提出了一个椎间盘假体组件，包括至少三个部分，包括一个称为下板的板(1)和称为上板的板(3)，环绕着至少一个称为内核(2)的中间部分产生一个在上述零件承载表面(12，15，21，23，32)之间支承和滑动着的活节接合，这些零件之一至少包括一个突出部分或不平形状，与至少另一个上述零件的形状配合来形成一个挡块，限制内核活动的可能性，其特征在于：与下板(1)和上板(3)接触的内核(2)承载表面(21，21a，23)具有对称轴线(分别为d21，d23)，它们之间形成一个不为零的确定角度(a2)，使得施加在两个板(1，3)上沿着垂直其外表面方向的压力(F)引入这些板相互倾斜的一个角度(a3)。
按照一个特定方面，这个组件的特征在于：挡块的功能采用在承载表面之外的至少一个挡块，包括至少一个部分(161，163)，从位于上述板承载表面(12，15)之外的至少一个板(1)上突出，并且包括向着假体内部的一个面，这个面与位于内核承载表面(21，23)之外的内核(2)周边部分(6)配合，其中表面朝着内核的外部，在近似垂直于脊椎的平面内，限制内核的移动或转动或其两者。
按照一个特定方面，当两个板使它们的外面(10，30)相互平行时，它们的承载表面(12，12a，32)与具有对称轴线(d12，d32)的内核(2)承载表面(21，21a，23)配合，它们之间形成一个确定角度(a4)，使得施加在两个板(1，3)上沿着垂直其外表面方向的压力(F)引入这些板相互倾斜的一个角度(a5)。
按照一个特定方面，由下板(1)内面和上板(3)内面提供的承载表面(12，32)每个均与内核(2)的支承表面(分别为21，23)互补接触，每个分别具有凸和凹形，或者相反，这个内核本身具有一个周边(20)，近似为沿着其接触面(21，32)对称轴线的圆柱形。
按照一个特定方面，下板(1)内面具有一个承载表面(12a)，与内核(2)下面的承载表面(21a)配合，上述内核在其上面包括一个凸承载表面(23)，与上板(3)内面的凹承载表面(32)互补接触，下板内面的承载表面(12a)延伸到足以容许内核相对于上述下板的活动。
按照一个特定方面，称为块(5)的一个中间零件附加在板之一(1)的内面，环绕内核(2)产生一个与另一个板(3)的活节接合，内核具有一个凹的承载表面(21)和一个凸的承载表面(23)，这两个承载表面一方面以互补方式与块(5)的一个承载表面(52)接触，另一方面与不包括块的板(3)内面的承载表面(32)接触。
按照一个特定方面，块(5)凹承载表面(52)的对称轴线(d52)与一条轴线(d51)形成一个确定的角度(a4)，轴线(51)垂直于与板(1)接触的表面(51)，使得施加在两个板(1，3)上沿着垂直其外表面方向的压力(F)引入这些板相互倾斜的一个角度(a5)。
按照一个特定方面，至少一个承载表面(12，52，21，23，32)容许活节接合具有一部分为球的形状。
按照一个特定方面，内核(2)两个面的承载表面具有一部分为球的形状，具有凹承载表面(21)的面的半径大于具有凸承载表面(23)的面的半径。
按照一个特定方面，每个板(1，3)在其外面包括一个或几个小截面的突出部分，形成椎骨的固定连接，一旦假体在两个椎骨或骨元件(V)之间定位，在压力作用下这些突出部分嵌入或压入邻近骨元件(V)的表面中。
按照一个特定方面，假体的一个或几个零件包括不平形状、缺口(7)或穿孔，易于再接受一个工具来协助取出上述假体。
按照一个特定方面，板(1，3)由钴-铬不锈钢基的合金制成，内核(2)具有聚乙烯基。
按照同样的精神，本发明提出了一个器件，用于插入或安装按照权利要求1到17之一的假体，其特征在于：它包括一个具有内通道(90)的插入导座(9，93)，  内通道具有一个端部，其中某些边或支承边(910，920，931，932)沿着通道纵轴(d9)从其他边突出，从而能够替代先前采用的已知类型的脱位工具，以增加椎间盘空间的开口，这个通道(90)具有一个内截面，能够在脱位工具保持这个开口时包围它们，然后容许通过上述通道取出它们，而上述支承边(910，920，931，932)则替代脱位工具来保持椎间盘空间的开口，然后容纳和引导假体(P)插入这个椎间盘空间。
按照一个特定方面，在沿着垂直于插入方向的截面中，内通道(90)具有一个近似矩形截面，或者具有一个与假体外部轮廓大致相补的形状。
按照一个特定方面，在包含脊椎轴线的平面中，插入导座(93)的支承边(931，932)形成通道(90)壁的一个延伸部分。
按照一个特定方面，插入导座(9)由至少两个零件(91，92)形成，它们沿着平行于通道纵轴(d9)的一个或几个平面分开，这些零件每一个包括通道横截面的至少一部分，并且能够按照一个确定的角度(a9)分开，容许在通道中引入和滑动假体(P)。
按照一个特定方面，在与假体(P)板(1，3)外面对着的壁上，通道(90)内表面包括至少一个槽(913，914)，当假体在这个通道(90)中移动时，容许设在这些板上用于固定的突出部分(8，81)通过。
按照一个特定方面，器件包括假体的接近装置(95)，能够容纳假体和能够把所有不同部分与假体保持一起，接近装置(95)能够用锁定装置与插入导座(93)连接，从而可把假体放在通道(90)入口，处于适合进入通道(90)的位置。
按照一个特定方面，器件包括称为压紧器(96)的插入装置，把假体压入插入导座(93)的通道(90)中，然后进入椎间盘空间，这个压紧器由接近装置(95)引导，从而在与通道(90)入口位置相反的假体部分上与假体接触，这个压紧器能够施加或传递压力或重复冲击到假体，使它滑入通道，然后插入椎间盘空间。
按照一个特定方面，接近装置包括两个轴(951，952)，沿一条轴线连接到一个装配端(955)，这些轴能够闭合来把假体(P)夹紧在它们之中，并且保持假体被装配，这两个轴的每一个对导座(93)提供连接装置，然后这个连接装置保持这两个轴闭合在假体上。
对于熟悉这些技术的人员来说，显然本发明容许无数其他具体形式的实施例而不脱离所申请的本发明应用领域。因此，必须考虑本实施例仅为说明方式，而可以在所附权利要求范围规定的领域内修改，并且本发明不一定限于以上给出的细节。

Claims (25)

1.一个椎间盘假体组件包括至少三个部分，这些部分包括一个称为下板的板(1)和称为上板的板(3)，环绕着至少一个称为内核(2)的中间部分产生一个在上述零件承载表面(12，15，21，23，32)之间支承和滑动的活节接合，这些零件之一包括至少一个突出部分或不平形状，与至少另一个上述零件的形状配合来形成一个挡块，限制内核活动的可能性，其特征在于：这种挡块功能采用至少一个在承载表面之外的挡块，包括从至少一个板(1)上突出的至少一个部分(161，163)，位于上述板承载表面(12，15)之外和包括一个朝着假体内部的面，这个面与位于内核承载表面(21，23)之外的内核(2)周边部分(6)配合，其中表面朝着内核的外部，在近似垂直于脊椎的平面内，限制内核的移动或转动或其两者。
2.按照权利要求1的组件，特征在于：与下板(1)和上板(3)接触的内核(2)承载表面(21，21a，23)具有对称轴线(分别为d21，d23)，它们之间形成一个不为零的确定角度(a2)，使得施加在两个板(1，3)上沿着垂直其外表面方向的压力(F)引入这些板相互倾斜的一个角度(a3)。
3.按照权利要求1到2的组件，特征在于：由于在由挡块表面相互支承的零件(6，161，163)之间的接触，使得这个外挡块限制了内核(2)相对于至少一个板(1)的转动，这个支承沿着近似平行于每个挡块表面法线的方向。
4.按照权利要求1到3的组件，特征在于：外挡块包括一个从内核(2)上突出的舌片(6)，依靠限制这个舌片(6)在由立柱(161)限定的一个凹区(162)中，立柱从上述板(1)内面突出，或者依靠一个把这个舌片分成两个臂的凹区(66)，臂包围着从上述板(1)内面突出的一个立柱(163)，舌片与板之一(1)配合，这里板内面定义为向着内核一侧的面。
5.按照权利要求1到4的组件，特征在于：至少一个立柱(161，161，163)端部具有比它底部大的截面，这个增大的立柱与内核(2)外挡块舌片(6)的形状配合，相对于提供这个立柱的板(1)，限制了上述内核的升高。
6.一个椎间盘假体组件包括至少三个部分，包括一个称为下板的板(1)和称为上板的板(3)，环绕着至少一个称为内核(2)的中间部分产生一个在上述零件承载表面(12，15，21，23，32)之间支承和滑动着的活节接合，这些零件之一至少包括一个突出部分或不平形状，与至少另一个上述零件的形状配合来形成一个挡块，限制内核活动的可能性，其特征在于：与下板(1)和上板(3)接触的内核(2)承载表面(21，21a，23)具有对称轴线(分别为d21，d23)，它们之间形成一个不为零的确定角度(a2)，使得施加在两个板(1，3)上沿着垂直其外表面方向的压力(F)引入这些板相互倾斜的一个角度(a3)。
7.按照权利要求6的组件，特征在于：挡块的功能采用在承载表面之外的至少一个挡块，包括至少一个部分(161，163)，从位于上述板承载表面(12，15)之外的至少一个板(1)上突出，并且包括向着假体内部的一个面，这个面与位于内核承载表面(21，23)之外的内核(2)周边部分(6)配合，其中表面朝着内核的外部，在近似垂直于脊椎的平面内，限制内核的移动或转动或其两者。
8.按照权利要求1到6之一的组件，特征在于：当两个板使它们的外面(10，30)相互平行时，它们的承载表面(12，12a，32)与具有对称轴线(d12，d32)的内核(2)承载表面(21，21a，23)配合，它们之间形成一个确定角度(a4)，使得施加在两个板(1，3)上沿着垂直其外表面方向的压力(F)引入这些板相互倾斜的一个角度(a5)。
9.按照权利要求1到6之一或按照权利要求8的组件，特征在于：由下板(1)内面和上板(3)内面提供的承载表面(12，32)每个均与内核(2)的支承表面(分别为21，23)互补接触，每个分别具有凸和凹形，或者相反，这个内核本身具有一个周边(20)，近似为沿着其接触面(21，32)对称轴线的圆柱形。
10.按照权利要求1到3或8到9中的一个的组件，特征在于：下板(1)内面具有一个承载表面(12a)，与内核(2)下面的承载表面(21a)配合，上述内核在其上面包括一个凸承载表面(23)，与上板(3)内面的凹承载表面(32)互补接触，下板内面的承载表面(12a)延伸到足以容许内核相对于上述下板的活动。
11.按照权利要求1到6或8到10中的一个的组件，特征在于：称为块(5)的一个中间零件附加在板之一(1)的内面，环绕内核(2)产生一个与另一个板(3)的活节接合，内核具有一个凹的承载表面(21)和一个凸的承载表面(23)，这两个承载表面一方面以互补方式与块(5)的一个承载表面(52)接触，另一方面与不包括块的板(3)内面的承载表面(32)接触。
12.按照权利要求11的组件，特征在于：块(5)凹承载表面(52)的对称轴线(d52)与一条轴线(d51)形成一个确定的角度(a4)，轴线(51)垂直于与板(1)接触的表面(51)，使得施加在两个板(1，3)上沿着垂直其外表面方向的压力(F)引入这些板相互倾斜的一个角度(a5)。
13.按照权利要求1到6或8到12中的一个的组件，特征在于：至少一个承载表面(12，52，21，23，32)容许活节接合具有一部分为球的形状。
14.按照权利要求1到6或8到13中的一个的组件，特征在于：内核(2)两个面的承载表面具有一部分为球的形状，具有凹承载表面(21)的面的半径大于具有凸承载表面(23)的面的半径。
15.按照权利要求1到6或8到14中的一个的组件，特征在于：每个板(1，3)在其外面包括一个或几个小截面的突出部分，形成椎骨的固定连接，一旦假体在两个椎骨或骨元件(V)之间定位，在压力作用下这些突出部分嵌入或压入邻近骨元件(V)的表面中。
16.按照权利要求1到6或8到15中的一个的组件，特征在于：假体的一个或几个零件包括不平形状、缺口(7)或穿孔，易于再接受一个工具来协助取出上述假体。
17.按照权利要求1到6或8到15中的一个的组件，特征在于：板(1，3)由钴-铬不锈钢基的合金制成，内核(2)具有聚乙烯基。
18.一个器件，用于插入或安装按照权利要求1到17之一的假体，特征在于：它包括一个具有内通道(90)的插入导座(9，93)，内通道具有一个端部，其中某些边或支承边(910，920，931，932)沿着通道纵轴(d9)从其他边突出，从而能够替代先前采用的已知类型的脱位工具，以增加椎间盘空间的开口，这个通道(90)具有一个内截面，能够在脱位工具保持这个开口时包围它们，然后容许通过上述通道取出它们，而上述支承边(910，920，931，932)则替代脱位工具来保持椎间盘空间的开口，然后容纳和引导假体(P)插入这个椎间盘空间。
19.按照权利要求18的安装假体器件，特征在于：在沿着垂直于插入方向的截面中，内通道(90)具有一个近似矩形截面，或者具有一个与假体外部轮廓大致相补的形状。
20.按照权利要求18到19之一的安装假体器件，特征在于：在包含脊椎轴线的平面中，插入导座(93)的支承边(931，932)形成通道(90)壁的一个延伸部分。
21.按照权利要求18到20之一的安装假体器件，特征在于：插入导座(9)由至少两个零件(91，92)形成，它们沿着平行于通道纵轴(d9)的一个或几个平面分开，这些零件每一个包括通道横截面的至少一部分，并且能够按照一个确定的角度(a9)分开，容许在通道中引入和滑动假体(P)。
22.按照权利要求18到21之一的安装假体器件，特征在于：在与假体(P)板(1，3)外面对着的壁上，通道(90)内表面包括至少一个槽(913，914)，当假体在这个通道(90)中移动时，容许设在这些板上用于固定的突出部分(8，81)通过。
23.按照权利要求18到22之一的安装假体器件，特征在于：器件包括假体的接近装置(95)，能够容纳假体和能够把所有不同部分与假体保持一起，接近装置(95)能够用锁定装置与插入导座(93)连接，从而可把假体放在通道(90)入口，处于适合进入通道(90)的位置。
24.按照权利要求18到23之一的安装假体器件，特征在于：器件包括称为假体压紧器(96)的插入装置，把假体压入插入导座(93)的通道(90)中，然后进入椎间盘空间，这个压紧器由接近装置(95)引导，从而在与通道(90)入口位置相反的假体部分上与假体接触，这个压紧器能够施加或传递压力或重复冲击到假体，使它滑入通道，然后插入椎间盘空间。
25.按照权利要求18到24之一的安装假体器件，特征在于：接近装置包括两个轴(951，952)，沿一条轴连接到一个装配端(955)，这些轴能够闭合来把假体(P)夹紧在它们之中，并且保持假体被装配，这两个轴的每一个对导座(93)提供连接装置，然后这个连接装置保持这两个轴闭合在假体上。
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CN101111207B (zh) * 2004-12-22 2012-02-15 Ldr医疗公司 椎间盘假体
CN102551924B (zh) * 2004-12-22 2016-08-17 Ldr医疗公司 椎间盘假体
CN101170968B (zh) * 2005-05-03 2010-08-25 斯宾阿特有限公司 椎间盘假体
CN103211669A (zh) * 2006-03-14 2013-07-24 西畔亚特股份公司 椎间盘假体
CN105105890A (zh) * 2015-08-31 2015-12-02 北京市春立正达医疗器械股份有限公司 一种颈椎椎间盘假体
CN106236334A (zh) * 2016-09-30 2016-12-21 深圳清华大学研究院 人工颈椎椎间盘假体
CN108836580A (zh) * 2018-07-06 2018-11-20 北京爱康宜诚医疗器材有限公司 人工椎间盘架体
CN108969162A (zh) * 2018-07-27 2018-12-11 深圳清华大学研究院 一种椎间运动保留装置

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US20180098859A1 (en) 2018-04-12
CA2602540A1 (en) 2002-11-14
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CA2446095C (en) 2008-12-02
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IL158740A (en) 2008-06-05
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WO2002089701A2 (en) 2002-11-14

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