CN1419431A - 笼架形椎间植入物 - Google Patents

笼架形椎间植入物 Download PDF

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Publication number
CN1419431A
CN1419431A CN01807012A CN01807012A CN1419431A CN 1419431 A CN1419431 A CN 1419431A CN 01807012 A CN01807012 A CN 01807012A CN 01807012 A CN01807012 A CN 01807012A CN 1419431 A CN1419431 A CN 1419431A
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CN
China
Prior art keywords
cage
afterbody
hole
sidewall
millimeters
Prior art date
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Pending
Application number
CN01807012A
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English (en)
Inventor
O·莫雷特
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Scolio GmbH
Original Assignee
Scolio GmbH
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Filing date
Publication date
Application filed by Scolio GmbH filed Critical Scolio GmbH
Publication of CN1419431A publication Critical patent/CN1419431A/zh
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    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/4465—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
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Abstract

本发明涉及笼架形椎间植入物，它由一凹弯侧壁(1)、一隆凸侧壁(2)、一前部(3)和一尾部(4)和至少一道隔壁(5，6)构成并因而有至少两个空腔(7，8，9)。一上笼架面和一下笼架面(10，11)朝向前部－尾部地形成一个第一脊椎前凸角(α1)并与之垂直地形成一个第二脊椎前凸角(α2)，在这里，笼架面(10，11)在笼架外相交。因此，笼架结构的特点是双楔形几何形状(双楔形笼架)，这种几何形状取决于两个脊椎前凸角(α2和α1)并且有利地适应于椎间区的人体结构。此外，笼架的特点是倾覆力矩高，这个力矩有效地阻止了笼架倾覆。笼架结构制造方法作为主要步骤地规定了借助高压水流束来加工笼架材料。事实证明，该冷切割法是非常经济的。

Description

笼架形椎间植入物
技术领域
本发明涉及根据权利要求1的笼架形椎间植入物及根据权利要求23的其制造方法。
背景技术
本发明涉及椎间植入物及其制造方法，这种植入物被用在脊椎的两个椎体之间，它起到了两个椎体的关节固定作用并因而通过它来获得最初的椎间盘高度并也使神经根孔恢复其原始尺寸。
脊椎的各块椎骨具有一椎体、一椎弓、一棘突、两个横突和两个上关节突和两个下关节突。椎骨与相邻的椎间盘相连并且得到椎体。椎间盘由富液纤维软骨构成并且将各椎体连接起来。椎间盘的大小对应于在人体中出现的负荷地从上往下递增。椎间盘起到了弹性缓冲作用并弹性减弱了冲击。
众所周知的是，椎间盘可以围拢，或者内胶芯因撕裂而可能出现在结缔组织状的软骨外环中。此外，椎间盘可能部分进入椎间孔中或者进入脊髓腔中。另外，这种突出可能是向背侧的、向中间的或向体侧的。这样的突出最经常出现在L4-L5-S1和C6-C7椎骨上。如果不治疗这样的突出，则会出现对神经根孔的压力损伤或者横断性损害。如果典型的物理治疗如医疗体操或按摩不起效，则必须通过手术使椎间盘分开。现在，存在着植入这样的植入物(笼架)的可行方案，由此一来，可能在两个椎体之间发生关节病。
从EP0916323A1中知道了一种椎间植入物，它具有豆状结构并且可被装在椎骨之间。所述植入物具有一个楔形，它是通过两个纵侧壁的不同高度产生的。包围植入物的壁设有成行的孔，以促进与骨组织共生。不利的是，植入物只在一个方向上具有楔形并且由于侧设孔的数量大而加工起来很费事。
另外，公开了以“Brantigan Cage”命名的笼架结构，它们给其笼架面配备了许多齿，以防止笼架不希望的移动。它们由聚醚醚酮制成地(作为PEEK压制件)具有不够的强度，其在受力情况下可能导致笼架结构断裂。为了接纳器械而设置一个单头螺纹，由此得到不充分的器械操作。由于成方形几何形状而产生一个较小的倾覆力矩，这产生了不利的影响。
发明内容
本发明的任务是提供笼架形椎间植入物，它具有由两个脊椎前凸角决定的双楔形几何形状并且确保了更好的器械操作。本发明的另一个任务是制造这样的植入物。
根据本发明，利用一种按照权利要求1措辞的植入物并通过一种按照权利要求23措辞的该植入物的制造方法来完成所述任务。
附图说明
以下，结合图来描述本发明，其中：
图1是笼架的透视图；
图2是图1的笼架的俯视图；
图3A-3D是图2的截面图；
图4A-4C是图2的截面图；
图5是沿展开的径向线a-a′的图2的截面图；
图6A-6B是具有不同地安置的导向件的尾部的侧视图；
图7以俯视图示出了一个有一隔壁和带凹槽的倾斜尾部的笼架的
实施例。
实施方式的具体描述
图1以透视图示出了一个笼架100，它由一凹弯侧壁1、一隆凸侧壁2、一前部3和一尾部4构成。侧壁1、2通过隔壁5、6相连，从而笼架内部被分成空腔7、8、9。此外，给内侧壁1配设了第一内曲率半径R1，给外侧壁2配设了第二外曲率半径R2。
侧壁1、2、隔壁5、6以及前部3和尾部4具有上界面或下界面，它们限定出一个上笼架面或下笼架面10、11。
凹弯侧壁1具有成圆形的凹槽13、14、15，它们大致设置于空腔7、8、9的中央并且是形成骨物质所必需的。隆凸侧壁2也可以有这样的凹槽(未示出)。
笼架面10、11在前部3、尾部4和隔壁5、6的区域内具有板状凸起24、25、26、27，其走向大致平行于笼架面，以后将描述其性能。
前部3成圆形并且通过一样的壁厚连接笼架侧壁1、2。它在前侧具有斜面23、23′，所述斜面使得在椎间区内插入和定位笼架变得简单了。尾部4成矩形并且也通过一样的壁厚连接笼架侧壁1、2。它在后侧具有一个孔20，所述孔具有内螺纹并且被设置用于器械安装。在孔20的两侧设有导向件21、22，在这里，它们例如成筋条状，但是它们也可以由成半圆柱形的凹槽构成。导向件用于引导器械并在松开器械时防止任何不允许的笼架转动。一旦笼架位于其在两块椎骨之间的最终位置上，而这通常是在器械轴线被垂直于病人后背平面地导向移动时才出现的，则可以从笼架中取下器械。事实证明，这种控制可能性是很有帮助并且是很有用的。
导向件或筋条21、22过渡到尾部4面的过渡段在筋条两侧被倒圆，以避免可能出现的缺口效应，这对由塑料或复合材料制成的实施方案来说是有意义的。在尾部4和前部3中，设置了用于接纳一个由高密度金属构成的标记的孔31、32、33。由钽构成的球和/或销特别适用于此。所述销设置在孔内，它们是垂直于或平行于孔20地设置的。这样，可以通过图象放大器在手术中观察并判断笼架的位置。
图2示出了按照截面A-A′至截面D-D′和截面E-E′至截面G-G′的图1的笼架100的俯视图。也可以看到径向线a-a′的走向，它经过笼架的中心。
图3A-3D表示按照图2的截面位置的笼架截面图。图3A表示尾部4的截面A-A′。可以看到用于接纳器械的孔20和用于标记的孔31、32。还可以看到，尾部外侧面的高度大于内侧面高度。因而，尾部顶面不再平行于底面(作为笼架面10、11局部)地延伸。这两个面构成一个脊椎前凸角α2，它等于0.1°-4°并最好是2°。在图3A中，为了看得更清楚而放大比例地示出了脊椎前凸角α2。在尾部的底侧上，用α2/2表示该角。
如果尾部外侧面的高度小于内侧面高度，则得到了笼架的相反偏斜或由笼架面10、11构成的楔形，其楔尖朝着相反方向。如果脊椎前凸角α2在上述两种情况下都等于零，则笼架面10、11作为特殊情况如极限情况地是平行的，但这只是笼架的一个不太优选的设计形式。在笼架面10、11局部上设置了凸起24、24′，它们在这里是平行于笼架面地形成的，但它们不一定非要如此。
图3B、3C示出了带有凸起25、25′或26、26′的隔壁5或6的截面B-B′或C-C′，所述凸起设置在笼架面10、11局部上。这些凸起的走向也是平行于笼架面的，它们也允许看到脊椎前凸角α2。
图3D示出了前部3的截面D-D′。可以看到用于标记的孔33。可以看到凸起27、27′，它们设置于前部3笼架面10、11的局部上。所述凸起的走向也大致平行于笼架面，它们也允许看到脊椎前凸角α2。
都凸出到笼架面10、11外但只有0.3毫米-0.8毫米的凸起24、25、26、27用于在完成手术后锚固笼架并且有助于防止笼架移动。
图4A-4C按图2的截面位置表示笼架截面。可以看到侧壁1、2、上笼架面和下笼架面10、11以及仅在图4A中一侧示出的半个脊椎前凸角α2。
图5表示沿展开径向线a-a′的图2的截面图。可以在前部3中看到用于标记的孔33、斜面23、23′和凸起27、27′，可以在尾部4中看到孔20、凸起24、24′。隔壁5、6具有凸起25、25′或26、26′。
还可以看到，前部3的高度大于尾部4的高度。因此，笼架面10、11的走向不再是平行的。这两个面构成了一个所谓的脊椎前凸角α1，它等于2°-8°，但最好为3°、5°或7°。在图5中，为了看得更清楚而放大比例地示出了这个取决于脊椎前凸角α1的不平行情况。
当然，笼架结构可以在本发明范围内广泛地改变。因此，例如隔壁5、6的数量或空腔7、8、9的数量不局限于2或3个。有一个或多个隔壁的笼架结构是可行的。
图6A、6B分别示出了具有绕孔20而不同地设置的导向件21、22的尾部的侧视图。在图6A中，导向件是大致平行于笼架面10、11设置的，而在图6B中，它们与笼架面大致成45°。但是，这个角度可以取0-90°内的任何一个值。不过，导向件21、22也不一定非要被布置成是相互平行的，它们可以具有呈V形的布局。
作为材料，可以考虑使用塑料、碳纤维加强型塑料和金属或金属合金。优选使用这样的塑料，如聚醚醚酮(PEEK)、聚醚酮醚醚酮(PEKEEK)和聚砜(PS)，作为复合材料地特别优选由聚醚醚酮(CFK/PEEK)和聚醚酮醚醚酮(PEKEEK)构成的碳纤维加强型复合物，它们也被称为ULTRAPEK和OSTAPEK。
作为金属或金属合金，优选使用钛及其合金，例如根据ISO标准5832-3的钛合金Ti6-A14-V。金属笼架可以具有羟基磷灰石陶瓷(HAK)涂层或磷酸三钙(TCP)涂层，由此一来，有利地影响到植入物的长期性能。
由于笼架的弯曲形状，它具有一有利的高倾覆力矩M，这个力矩有效地阻止笼架倾覆。与具有相同的中心横截面和相同长度的方形笼架的倾覆力矩相比，事实证明本发明的笼架结构要高出至少1.30倍。对于图1的笼架来说，倍数等于1.58。
本发明笼架结构的优点来自于双楔形几何形状，这种几何形状是由两个脊椎前凸角α1、α2决定的并且出色地适应于椎间区内的人体结构。因此，“双楔形笼架”或“DWS笼架”名称也被用于这样的笼架。成型于笼架面上的凸起有效地防止了笼架在完成手术后在治疗过程中移位。
上述类型的笼架结构的特点是强度高，尽管用料少，但仍然获得了这样的高强度。这样一来，极大加速了骨物质的形成。事实证明，这种性能可以通过“笼架材料指数(CMI)”来描述，它是按照公式(I)定义的：
CMI＝笼架材料体积/笼架体积              (I)即，作为笼架材料体积与总的笼架体积之比。因此，
a)对于CFK/PEEK、CFK/PEKEK和CFK/PS来说，CMI小于0.25并最好是0.22，
b)对于钛或钛合金来说，CMI小于0.20并最好是0.17，
在这里，要考虑由笼架尺寸决定的变化并且这样的变化只带来不重要的差异。
接着，描述制造这样的笼架的方法。
该方法分以下四步进行：
1、水流束切割
在第一步骤中，在第一方向上借助高压水流束来加工由笼架材料制成的毛坯。这种已知的经济的冷切割法一般以3000巴的冲蚀剂来工作(U.W.Hunziker-Jost，Schweizer Prazision-Fertigungstechnik，第81-86页，汉瑟出版社，慕尼黑(1991))。毛坯被如此紧固住，即水流束垂直于后来的笼架面。此时，高精度地切割出前部3、尾部4的侧壁1、2的形状及至少一个隔壁5、6和至少两个空腔7、8、9与导向件21、22的形状。切割边几乎没有毛边。在材料厚度为10毫米的情况下，在仿形切割中获得了高达100毫米/分的金属切割速度和高达300毫米/分的复合材料切割速度。
2、铣削
现在，如此从毛坯中分离出来笼架坯在第二步骤中被重新夹紧，确切地说是在大致垂直于第一方向的第二方向上，在这个方向上，用铣刀继续加工笼架坯。根据第一脊椎前凸角α1地铣削笼架面10、11，按照第二脊椎前凸角α2地铣削板状凸起24、25、26、27，并且铣削出前部3的斜面23、23′、侧壁1的至少一个凹槽和第一孔20。在第二步骤中，也给孔20攻制上内螺纹，所述内螺纹是为接纳器械而设的。在这种情况下，在数控(CNC)自动铣床上使用小口径铣刀组件。如果在外侧壁2上也设置凹槽，则必须再次重新固定笼架坯。
3、安装标记
在第三步骤中，把标记装在笼架坯上，所述标记使得随后在手术时和手术后借助一个图象放大器来判断笼架位置成为可能。装上在尾部中的标记用第二孔和在前部中的标记用第二孔31、32、33，标记成由钽制成的球和/或销的形式地被装入所述孔中。
4、终加工
在第四步骤中，进行被概括为终加工的最后作业，即善后处理(Trovalisieren)，以便给局部锋利的边缘清除毛刺或倒圆。随后，进行笼架的打标，这例如可借助激光打标机来进行。接着，笼架接受清洗加工，它例如包括多级超声波清洗。笼架的包装也属于终加工。
主要的方法步骤是用高压水流束进行切割。因此，选择一种有利的分离方法，它被证明是非常经济的。
随后描述的例子让人们了解到了各式各样的笼架设计方案，举出这样的例子决不应被视为是穷举。
图7作为实施例地以俯视图示出了一个具有一道隔壁和一个带凹槽的倾斜尾部的笼架。侧壁1、2、带凸起和斜面23的前部3、带凸起的隔壁5、空腔7、9对应于图1所述的笼架部件。但是，带有相对笼架面凸起的凸起的尾部4在这里具有一个菱形形状。尽管在这里成凹槽形式的导向件21、22与图1一样地设置在尾部面4′上，但示出了用于接纳器械的孔指向空腔7边缘，这通过用于孔的轴30位置来表示。所述孔攻制有内螺纹M4。笼架面朝向前部-尾部地构成一个3°的脊椎前凸角α1并且朝向弯曲侧壁1、2的曲率半径中心地构成一个2°的脊椎前凸角α2。因此，带凸起的隔壁的高度在外侧面处为8.1毫米，在内侧面处为7.8毫米。侧壁1具有两个侧凹槽，它们大致位于空腔7、9的中心。内曲率半径R1等于11毫米，外曲率半径R2等于19毫米。其中对应的中心错开1.1毫米。这个笼架是由CFK/PEEK制成的，在这里，在第一方法步骤中采用了水流束切割设备BYJET(Bystronic LaserAG，CH-3362 Niederoenz)。
作为其它实施例地，根据图6的笼架结构由按照ISO标准5832-3的钛合金Ti6-Al4-V制成，在这里，在第一方法步骤中也采用了水流束切割设备BYJET。

Claims (27)

1、用于笼架形椎间植入物的笼架，它包括一被分成空腔的笼架体，其特征在于，笼架(100)由一凹弯侧壁(1)、一隆凸侧壁(2)、一前部(3)和一尾部(4)构成，其中给内侧壁(1)配属一个第一内曲率半径(R1)并给外侧壁(2)配属一个第二外曲率半径(R2)，所述侧壁与所述前部和所述尾部相连，侧壁(1，2)与至少一道隔壁(5，6)相连，所述隔壁大致垂直于所述侧壁，由此一来，笼架(100)具有至少两个空腔(7，8，9)并且侧壁(1，2)、前部(3)和尾部(4)和所述的至少一道隔壁(5，6)构成一上笼架面和一下笼架面(10，11)，其中所述下笼架面如此朝向前部-尾部地形成一个第一脊椎前凸角(α1)并与之垂直地形成一个第二脊椎前凸角(α2)，即笼架面(10，11)在笼架外相交。
2、如权利要求1所述的笼架，其特征在于，内侧壁(1)具有小于外侧壁(2)的高度，或者外侧壁(2)具有小于内侧壁(1)的高度，这样一来，形成了一个第二脊椎前凸角(α2)。
3、如权利要求1或2所述的笼架，其特征在于，前部(3)和尾部(4)大致具有相同的第二脊椎前凸角(α2)。
4、如权利要求1-3之一所述的笼架，其特征在于，脊椎前凸角(α1)等于2°-8°并最好为3°、5°或7°。
5、如权利要求1-4之一所述的笼架，其特征在于，脊椎前凸角(α2)等于0.1°-4°并最好是2°，在极端情况下，它等于零。
6、如权利要求1-5之一所述的笼架，其特征在于，第一内曲率半径(R1)和第二外曲率半径(R2)大致具有相同的中心，但最好是错开设置的中心。
7、如权利要求1-6之一所述的笼架，其特征在于，第一内曲率半径(R1)等于15毫米-23毫米并最好是22毫米，第二外曲率半径(R2)等于18毫米-26毫米并最好是19毫米、21毫米或23毫米。
8、如权利要求1-7之一所述的笼架，其特征在于，内侧壁(1)具有至少一个凹槽(13，14，15)。
9、如权利要求1-8之一所述的笼架，其特征在于，外侧壁(2)具有至少一个凹槽。
10、如权利要求1-9之一所述的笼架，其特征在于，前部(3)成倒圆形状并且具有至少一个斜面(23)。
11、如权利要求1-10之一所述的笼架，其特征在于，尾部(4)在其中心具有一个带内螺纹的孔(20)，该孔被两个其走向大致平行或成V形延伸的导向件(21，22)围住。
12、如权利要求11所述的笼架，其特征在于，导向件(21，22)是大致垂直于或大致平行于或相对笼架面成0-90°并最好是45°角地绕孔(20)设置的。
13、如权利要求11或12所述的笼架，其特征在于，导向件(21，22)成筋条或凹槽形状。
14、如权利要求1-13之一所述的笼架，其特征在于，在前部(3)和尾部(4)中设置了用于由高密度金属制成的且成球和/或销形状的标记的孔(31，32，33)。
15、如权利要求14所述的笼架，其特征在于，钽被规定作为标记用金属。
16、如权利要求14或15所述的笼架，其特征在于，成销状的标记是大致垂直于或平行于孔(20)地设置的。
17、如权利要求1-16之一所述的笼架，其特征在于，笼架面(10，11)具有板状凸起(24，25，26，27)，它们大致平行于所述笼架面地延伸。
18、如权利要求1-17之一所述的笼架，其特征在于，所述笼架具有一个对准内曲率半径(R1)的中心的倾覆力矩(M)，这个倾覆力矩与横截面相同、长度相同且笼架结构相似的方形笼架的倾覆力矩相比而高出至少1.30倍。
19、如权利要求1-18之一所述的笼架，其特征在于，它由塑料并且优选地是由聚醚醚酮(PEEK)、聚醚酮醚醚酮(PEKEEK)或聚砜(PS)制成，或者由复合材料构成并最好由由CFK/PEEK和CFK/PEKEEK构成的碳纤维加强型复合物构成。
20、如权利要求1-18之一所述的笼架，其特征在于，它由钛或钛合金构成。
21、如权利要求20所述的笼架，其特征在于，它可以具有羟基磷灰石陶瓷(HAK)涂层或磷酸三钙(TCP)涂层。
22、如权利要求1-21之一所述的笼架，其特征在于，它具有笼架材料指数(CMI)，这个指数是按公式(I)定义的：
CMI＝笼架材料体积/笼架体积           (I)对于CFK/PEEK、CFK/PEKEK和PS来说，CMI小于0.25并最好是0.22，对于钛或钛合金来说，CMI小于0.20并最好是0.17。
23、制造如权利要求1-22之一所述的笼架的方法，其特征在于，在第一步骤中，在第一方向上借助高压水流束来切割一个由笼架材制成的毛坯，其中形成前部(3)和尾部(4)的侧壁(1，2)的形状、所述的至少一道隔壁(5，6)、所述的至少两个空腔(7，8，9)和导向件(21，22)的形状，在第二步骤中，在一个大致垂直于第一方向的第二方向上铣削该毛坯，在第三步骤中装上标记并且在第四步骤中进行终加工。
24、如权利要求23所述的方法，其特征在于，在第二步骤中，根据第一脊椎前凸角(α1)铣削笼架面(10，11)并按照第二脊椎前凸角(α2)铣削板状凸起(24，25，26，27)并且铣削出前部(3)的斜面(23，23′)、侧壁(1)的至少一个凹槽(13，14，15)和第一孔(20)。
25、如权利要求24所述的方法，其特征在于，给第一孔(20)攻制上内螺纹。
26、如权利要求22-25之一所述的方法，其特征在于，在第三步骤中，设置用于所述标记的第二孔(31，32，33)并装入所述标记。
27、如权利要求22-26之一所述的方法，其特征在于，所述加工毛坯的终加工包括善后处理、打标、清洗和包装。
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ATE251429T1 (de) 2003-10-15
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AU2001240410A1 (en) 2001-10-03
HK1052627A1 (en) 2003-09-26
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DK1274375T3 (da) 2004-02-09
WO2001070144A1 (de) 2001-09-27
CA2404086A1 (en) 2002-09-19
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TR200302303T4 (tr) 2004-01-21
JP2003527196A (ja) 2003-09-16

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