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CN1649552A - 颈部椎间假体 - Google Patents

颈部椎间假体 Download PDF

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Publication number
CN1649552A
CN1649552A CNA03805695XA CN03805695A CN1649552A CN 1649552 A CN1649552 A CN 1649552A CN A03805695X A CNA03805695X A CN A03805695XA CN 03805695 A CN03805695 A CN 03805695A CN 1649552 A CN1649552 A CN 1649552A
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tooth
intervertebral prostheses
vertebral body
cover plate
flange
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CN100536803C (zh
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A·凯勒
P·C·麦卡菲
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Waldemar Link GmbH and Co KG
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Waldemar Link GmbH and Co KG
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract

带有两个盖板的颈部椎间假体，其中盖板在各种情况下要与相邻椎体之一相连。至少两个盖板(1，3)之一具有面向椎体(7)的齿部(9)，齿部的齿具有陡的面向腹侧的齿侧面(10)和不太陡的面向背侧的齿侧面(11)。当假体以足够的压力被安装到其相邻椎体之间时，锯齿形齿部和抵靠表面的组合足以将假体牢固地保持在希望的位置。在许多情况下，这使得可以不采用额外的螺钉固定。在这种情况下，带有抵靠表面(16)的凸缘(15)最好缩短以使其能够容纳在骨(7)的凹槽内，并且假体不会在腹侧方向上伸出到超过相邻椎体(7)的腹侧对齐表面。

Description

颈部椎间假体
在脊柱颈部只有非常少的接收椎间假体的空间。甚至假体零件向后背方向轻微的偏移也会影响脊髓的神经。因此，牢固地固定假体是非常重要的。对于脊柱腰椎部分的椎间假体，已知的是为面对相邻椎体的假体盖板提供肋条或凸起，这些肋条或凸起接合在为椎体内准备好的凹槽内或设计成锋利的并可自行切割的。可行的原因在于腰部脊柱的椎体较大较高，因此有足够的空间供这类固定装置使用。这也适用于固定凸缘，其中固定凸缘位于假体盖板的腹侧边缘以接收用于将盖板固定到相关椎体上的接骨螺钉。颈部区域的椎体较小并且高度低，通常使得无法使用这些固定装置，从而所述固定装置显然不能满足要求。特别是必须避免假体在腹侧有凸出的部分，因为这些凸出部分会刺激正好位于其前方的食道。
因此，本发明的目的在于提供一种带有小固定元件的颈部椎间假体，其中该固定元件考虑了有限的空间条件但提供了足够的可靠性。
根据本发明的解决方案是通过权利要求的特征实现的。基本原理涉及使用两个相互作用的固定工具，即一方面涉及一个与骨配合的锯齿部，另一方面涉及一个抵靠件，其中所述锯齿部防止假体在腹侧方向上的相对运动并促进向背侧的相对运动，所述抵靠件可靠地限制向背侧的相对运动。
根据权利要求1，至少假体的两个盖板之一在其与相关椎体配合的表面上备有齿部，齿部包括至少一个齿，齿带有陡的面向腹侧的齿侧面和不太陡的面向背侧的齿侧面。通常将其称为锯齿。这些锯齿的作用是当盖板和相关椎体之间有相对运动时，在椎体上施加力，该力趋向于向背侧方向推椎体。因此，锯齿能够保证盖板和假体不会产生不希望的向腹侧方向的移动。可取的是在齿部中提供多个这类齿。齿最好象肋一样相对前后方向横向延伸。齿部应该基本覆盖整个表面。至少它应该大约覆盖面向椎体的可用表面的一半。齿必须足够高以能够产生足够的作用。另一方面，这些齿必须尽可能低以只占据小的垂直空间。已经证明，有利的是它们高度为0.2和0.6毫米之间，它们在前后方向上的间隔在0.5和2毫米之间。
只有盖板和相关的椎体之间存在相对运动时，齿部在背侧方向上施加的力才是有效的。这种相对运动是不希望有的，因为在通常情况下，很明显希望盖板和相关椎体之间是绝对固定的。事实上，可以被看作宏观粗糙结构的齿通常有助于保持盖板和相关椎体之间的固定状态。这一点可通过这样的方法得到进一步的加强，即在假体表面上提供促进骨和假体表面之间密切连接的涂层，例如促进骨生长的多微孔材料和/或生物活性材料。
在发生相对运动时，齿部在背侧方向上向盖板施加的力被抵靠表面抵销，其中抵靠表面位于盖板的腹侧边缘上以与相关椎体的腹侧边缘配合。该抵靠表面的作用是这样的，即仅在夹板的抵靠表面靠接在椎体腹侧边缘上之前，锯齿的力才能使盖板，并从而也使假体向背侧方向上移动。尺寸是这样选择的，即当抵靠表面靠接在椎体腹侧边缘上时，假体精确到达其希望的位置。
抵靠表面最好由凸缘形成，凸缘对称布置在盖板的腹侧边缘上，其宽度最好至少为盖板中横向尺寸的一半。其结果是，凸缘始终平行地抵靠在椎体的腹侧边缘上，并且避免了希望的假体前后轴线相对椎体前后方向发生倾斜。
凸缘可备有孔以接收固定元件，例如接骨螺钉。但在大多数情况下是没有必要的。更加有利的设计是没有这种螺钉孔，并且凸缘高度较低以能够仅施加其抵靠作用。这是因为可以在椎体中形成一个接收凸缘的凹槽。其结果是，假体可相对相邻椎体的腹侧对齐表面向背侧一直推进到它不会对那里的食道或任何神经或脉管产生刺激为止。从腹侧方向看，假体甚至可一直保持完全位于该对齐表面后面，并从而可完全锚定在椎体区域。不用螺钉孔还有这样的优点，即凸缘高度可以非常低，从而植入物非常小并可通过例如内窥镜的窄进入通路植入。
如果锯齿设计为相对前后方向横向延伸的肋，那么存在盖板相对相关的椎体在这些肋的方向上移动的可能性。这种现象可通过提供相对齿肋方向横向延伸的凹槽或肋来避免。凹槽允许骨质向内生长并从而防止了不希望的横向运动。任何提供的肋最好是可自行切割的，这样当插入假体时，它们就能穿透到椎体的表面内。
抵靠表面不必由凸缘形成。代为替代，相对盖板平面横向伸出的凸起在许多情况下就足够了。这些凸起应该成对对称布置，以允许使假体的方向与椎体的方向一致。在一对对称布置且相互间隔开的凸起上形成抵靠表面具有这样的优点，即通常位于食道附近的椎体腹侧中心区域没有假体零件。
所有的假体腹侧边缘和棱边都应该做成圆形的以使其刺激相邻器官的可能性最小。
下面参考示出有利的示例性实施例的附图更详细地描述本发明。在附图中：
图1示出了基本按实际比例的假体上端板的平面图，
图2以放大的比例示出了同一结构，
图3以与图2对应的比例示出了前后方向的剖面。
假体包括下盖板1，假体核2和上盖板3，其中所述上盖板由硬的耐久材料，特别是金属制成，所述假体核由具有良好滑动特性的聚乙烯或其它塑料制成，所述上盖板由和下盖板1相同的材料制成。假体核2与下盖板1牢固连接，但还是可以拆开的。连接是通过下盖板1背侧和两个横向侧面上的凹槽凸缘4实现的，备有互补凹槽的假体核2可插入到这些凹槽凸缘内。在推入位置，假体核通过螺栓5固定。假体核2和上盖板3构成相互作用的，互补的，最好是球形的滑动表面6。
盖板1和3分别面对相关椎体7的表面设计成相同的。它们表面的较大部分由多个齿9覆盖，这些齿设计为锯齿形，即带有面向腹侧的陡的齿侧面10和面向背侧的不太陡的齿侧面11。陡的齿侧面可取的是基本与盖板延伸平面垂直。
齿9是肋形的，这些肋相对前后方向的中轴线8横向延伸并在中间断开以形成凹槽12。在凹槽12区域没有齿9。在所示示例中，凹槽的底面13与齿的底面重合并在图3中以虚线表示。但是，凹槽还可以更深些或更浅些。作为中心布置凹槽的替代方案，还可提供在表面上分布的多个可能更窄的凹槽。这里推荐对称布置。假体插入并与相邻骨质配合后，面向凹槽的齿9横向端面产生防止假体相对骨横向移动的阻力。在以后的使用中，由于骨质向凹槽12内生长，该阻力是增加的。
不用凹槽，还可通过相对形成齿9的肋延伸方向横向延伸的一个或多个肋产生这种作用。这些肋应该窄并且锋利，以在插入假体时，它们可容易地穿入到骨质内并不会妨碍随后盖板表面在各自相关骨表面上产生的紧配合。
为促进假体表面和骨表面之间的紧密接触，假体表面可备有涂层14，骨质可向涂层的孔内生长，或者涂层在生物学上促进骨质的结合。
在腹侧边缘，盖板1，3备有脊形凸起15，这些凸起在头部方向或尾部方向上延伸超过带有齿9的表面。由于其基本为平面，所以也将凸起称为凸缘。为简单起见，如图3中所示，当凸起仅具有很低的高度时，也使用这种表达方式。当植入时，该凸缘可这样定位，即其面向背侧的抵靠表面16位于相关椎体7的腹侧限制表面17前部。但根据解剖学的实际情况，由于这种布置可能使假体零件在腹侧上伸出到超过相邻椎体的对齐面23并对食道或其它器官造成刺激，所以可取的是这样的手术技术，即凸缘15凹进到骨内(如图3中所示)。换句话说，在椎体的腹侧边缘上去除少量材料以形成凹槽，凹槽的形状和尺寸与凸缘15匹配并在植入后接收凸缘。这样，凸缘的抵靠表面16靠在该凹槽的腹侧端面上。为使抵靠表面16紧靠在该端面上，可将凸缘的边缘18做成圆形的。这样骨不会被过度削弱，这要求凸缘超过带齿9表面的高度很低。该高度应该在0.5到2毫米量级上，可取的是在0.8和1.3毫米之间。如果用植入物在前后方向(AP方向)上最大尺寸的分数表示，这意味着可取的是0.5到2个齿。
凸缘高度低具有这样的优点，即与凸缘备有固定元件(例如螺钉孔)的实施例相比，植入物的尺寸大大减少了。尺寸的减少允许通过手术开口或相应小直径插入通道进行植入，例如在内窥镜植入过程中。
根据本发明的假体可非常牢固地安装，其中产生背侧“进给方向的”锯齿防止产生不希望的向腹侧方向的移动，而凸缘限制了假体向背侧方向的移动。从而保持了在植入时选定的位置，在该位置凸缘15的抵靠表面16靠接在相关椎体或在椎体中形成的凹槽的对应腹侧表面上。
通过齿9获得的假体安装的可靠性取决于安装的假体在相邻椎体之间受到足够的压力。如果保留了后部纵向韧带，那么这种压力通常是足够的。如果这是不可能的，则医生会优选考虑用接骨螺钉进行附加的固定。为此，提供了这样的设计，其中如点划线19所示，凸缘15的高度更高，并如点划线所示，包括用于接收接骨螺钉20的螺钉孔。如果进行手术的外科医生怀疑骨质量是否足以仅通过压配合和齿9就能牢固地锚定假体，那么这种设计也是推荐使用的。如果选择了具有较高凸缘的型式，则医生通常无需通过在椎体内形成的凹槽将该凸缘嵌入到椎体内，因为这样做可以使椎体被过度削弱。作为替代，在这种情况下，假体通常安装成使凸缘位于椎骨的腹侧表面前部。
为在任何情况下都能避免对相邻器官的刺激或使刺激最小，所有可能在腹侧方向上伸出超过相邻椎体对齐表面的边缘都做成圆形的，如例如边缘21所示。
假体的齿部9应该足够精细，使得植入后假体就能立刻到达其相对相邻椎体的最终位置。换句话说，应该避免这种情况，即在稍后的某个阶段，在相邻椎体之间进行挤压的过程中，齿过多沉入到椎体内。这实际上会伴随着椎骨之间神经通路横截面产生不希望的减少。在这方面，已经证明可用的齿高在0.2和0.6毫米之间，可取的是在0.3和0.5毫米之间，并且齿顶间距为0.4到2毫米。
腹侧抵靠表面16不必在假体整个宽度上延伸。作为替代，它还可由单独的间隔开的凸起构成，这些凸起最好对称布置。在图1中示出了两个这种凸起22。如图2中所示，如果提供了凸缘形的抵靠表面16，那么抵靠表面最好做成凹面形以与椎体的腹侧边缘匹配。如果凸缘没有螺钉孔并且相应缩短以结合到椎体的凹槽内，则直的抵靠表面16也是可以的，因为与其配合的凹槽端面可以任何希望的方式成形，而直线成形是特别简单的。

Claims (20)

1、带有两个盖板(1，3)的颈部椎间假体，其中两个盖板在各种情况下要连接在相邻椎体(7)上，其特征在于，至少两个盖板(1，3)之一具有面向椎体(7)的齿部(9)，该齿部具有至少一个齿(9)，齿(9)带有陡的面向腹侧的齿侧面(10)和不太陡的面向背侧的齿侧面(11)，其特征还在于，盖板(1，3)在其腹侧边缘具有与椎体(7)腹侧表面配合的面向背侧的抵靠表面(16)。
2、根据权利要求1中所述的椎间假体，其特征在于，两个盖板(1，3)都具有所述的齿部(9)和抵靠表面(16)。
3、根据权利要求1中所述的椎间假体，其特征在于，齿部由锯齿形的多个齿(9)组成，并且至少面向椎体(7)的表面的一半被齿部覆盖。
4、根据权利要求3中所述的椎间假体，其特征在于，几乎整个面向椎体(7)的表面都被齿部(9)覆盖。
5、根据权利要求3中所述的椎间假体，其特征在于，齿高在0.2到0.8毫米之间。
6、根据权利要求5中所述的椎间假体，其特征在于，齿距在0.4到2毫米之间。
7、根据权利要求3或4中所述的椎间假体，其特征在于，齿部的齿(9)相对前后方向(8)基本横向延伸。
8、根据权利要求7中所述的椎间假体，其特征在于，面向椎体(7)的表面具有相对齿部的齿横向延伸的凹槽(12)和/或肋。
9、根据权利要求3中所述的椎体假体，其特征在于，齿备有多孔和/或促进骨生长的涂层(14)。
10、根据权利要求1或2中所述的椎间假体，其特征在于，抵靠表面(16)由盖板(1，3)的腹侧凸缘(15)形成。
11、根据权利要求10中所述的椎间假体，其特征在于，凸缘(15，19)具有螺钉孔。
12、根据权利要求10中所述的椎间假体，其特征在于，凸缘(15)没有螺钉孔。
13、根据权利要求10中所述的椎间假体，其特征在于，凸缘超过带有齿部的表面(13)的高度为0.5到2毫米。
14、根据权利要求10中所述的椎间假体，其特征在于，凸缘(15)超过带有齿部的表面(13)的高度不大于盖板前后方向尺寸的五分之一。
15、根据权利要求10中所述的椎间假体，其特征在于，凸缘(15)的延伸宽度至少为盖板宽度的一半。
16、根据权利要求1或2中所述的椎间假体，其特征在于，抵靠表面(16)由两个凸起(22)形成，这两个凸起相互间隔开并相对盖板(1，3)的前后中心轴线(8)对称布置。
17、根据权利要求1或2中所述的椎间假体，其特征在于，腹侧边缘做成圆的。
18、用于插入颈部椎间假体的方法，其中假体具有至少一个备有齿部(9)和面向背侧的腹侧抵靠表面(16)的盖板(1，3)，在该方法中，在插入椎间假体之前，与该盖板(1，3)配合的椎体(7)在腹侧边缘备有凹槽以接收带有抵靠表面(16)的盖板(3)部分(15)。
19、根据权利要求14中所述的方法，其特征在于，凹槽在前后方向上的深度尺寸是这样的，即假体在食道方向上没有一部分明显超过相邻椎体(7)的腹侧对齐表面。
20、根据权利要求14中所述的方法，其特征在于，该方法是通过内窥镜法进行的。
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US7267691B2 (en) 2007-09-11
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