CN101115451B - 椎间假体 - Google Patents

椎间假体 Download PDF

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Publication number
CN101115451B
CN101115451B CN2005800451310A CN200580045131A CN101115451B CN 101115451 B CN101115451 B CN 101115451B CN 2005800451310 A CN2005800451310 A CN 2005800451310A CN 200580045131 A CN200580045131 A CN 200580045131A CN 101115451 B CN101115451 B CN 101115451B
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CN
China
Prior art keywords
calotte
mentioned
prosthetic component
intervertebral prostheses
prosthetic
Prior art date
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.)
Expired - Fee Related
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CN2005800451310A
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English (en)
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CN101115451A (zh
Inventor
B·莱希曼
R·弗里格
A·阿彭策勒
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Synthes USA LLC
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Synthes USA LLC
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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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    • 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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    • 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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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
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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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    • A61F2310/0073—Coating or prosthesis-covering structure made of compounds based on metal carbides
    • A61F2310/00748—Coating made of titanium carbide

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Neurology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • Holders For Sensitive Materials And Originals (AREA)
  • Belt Conveyors (AREA)
  • Portable Nailing Machines And Staplers (AREA)
  • Automatic Disk Changers (AREA)

Abstract

本发明公开了一种椎间假体，具有中心轴线，包括：A)第一假体部件，具有第一接合表面和第一内表面，二者横过中心轴线设置并具有球形凹槽；B)第二假体部件，具有第二接合表面和第二内表面，二者横过中心轴线设置并具有与上述凹槽叠合的帽状物；C)第一和第二假体部件，可通过帽状物用关节的方式连接，上述帽状物可滑动地接收在凹槽中；因而D)第一和第二假体部件具有宽度B和长度H，它们横过中心轴线，上述第一和第二假体部件还分别包括纵向轴线L1、L2，所述中心轴线L1、L2平行于相应的长度H延伸；因而E)，长度H大于宽度B，这样可以把假体部件放入椎间空间的位置中，其中两个纵向轴线L1和L2在与中心轴线垂直的平面中伸出时，两个纵向轴线L1和L2彼此相交成角度为α＞0°。

Description

椎间假体
技术领域
本发明涉及一种椎间假体，尤其是涉及一种椎间盘假体。
背景技术
近年来，椎间假体已在脊柱外科手术中获得了广泛接受。这些假体是在前面或前侧插在椎体之间代替椎间盘。这种植入技术存在某种危险，因为通路穿过腹部分区导引。有一危险是可能伤害前面腰脊柱的区域中较大的血管(vessel)。从生物力学观点来看，前面通路的缺点是脊柱的前面纵向韧带必须部分或全部切开，以便能插入假体。这种切开将导致脊柱的某种不稳定性，并且在最坏情况下可能促使假体的腹部移动。为了减少假体移动的危险，采用不同的锚固机构把假体固定在相邻椎体的盖板上。
这种类型的椎间假体从MARNAY的WO 01/01893中已知。这种已知的假体包括两个板，所述两个板具有球窝关节和两个不同形状的突出部分，用于将假体锚固在两个椎骨中。在上述文献中还提出在插入期间使假体的高度减至最小，因为两个假体相互接合。尽管提供了固定机构，但对假体来说仍有沿着插入通道回移的危险。
发明内容
本发明打算为此提供补救办法。依据本发明，提供一种椎间假体，包括：A.第一假体部件，所述第一假体部件具有第一接合表面和第一内表面，上述第一接合表面横过中心轴线设置，用于接触第一邻接椎体的端板，而上述第一内表面也横过中心轴线设置，并具有球形凹槽；B.第二假体部件，所述第二假体部件具有第二接合表面和第二内表面，上述第二接合表面横过中心轴线设置，用于接触第二邻接椎体的端板，而上述第二内表面也横过中心轴线设置，并具有与上述凹槽叠合的帽状物；因而C.第一和第二假体部件可用帽状物以关节的方式连接，所述帽状物可滑动地接收在凹槽中；D.第一和第二假体部件各具有横过中心轴线的宽度B和长度H，上述第一和第二假体部件还包括平行于各自的长度H延伸的纵向轴线L1、L2；因而E.长度H大于宽度B，以便可以把假体部件放入椎间空间内的一个位置中，当在垂直于中心轴线的平面中伸出时在上述位置中的两个纵向轴线L1和L2彼此以角度α＞0°相交，其中长度H与宽度B的比值是在3∶1和5∶1之间。
本发明涉及一种椎间假体，所述椎间假体用于植入目的可分解成两部分，并通过经椎间孔(transforaminal)和或外孔(extraforaminal)通路插入椎间空间。椎间假体的关节优选的是由球形帽状物和对应的球形凹槽组成。在植入两个假体部件期间，所述两个假体部件通过两个分开的通路分开植入到椎间空间中，假体部件的两个纵向轴线在椎间空间中彼此交叉。通过自由选定两个假体部件的纵向轴线之间的角度α，可以在插入点保持不变的情况下调节矢状方向上交点的位置。这种调节可以通过CT或X射线摄影在手术前绘制平面图，或者可以在手术期间内通过导丝和/或导板限定。
用本发明所得到的优点主要是由于本发明的椎间假体：
-可以对用于任何对椎体的椎间假体进行单独调节。因此，可以考虑运动元件的单独解剖；
-单独分段的运动次序可以由外科医生在手术之前考虑和限定；
-与以完全装配好的状态插入椎间空间的植入物相比，使得不复杂和安全的手术技术成为可能；
-使假体由于脊柱的弯曲/伸展或侧向弯曲而引起的前/后和/或侧向移动的危险减至最小；
-自然的椎间盘只必须部分地移走，亦即为了在椎间空间(椎间盘)中植入两个假体部件，只需要清理出宽度B和长度H的两条通路，从而仅有两个假体部件的接合表面处于与相应的端板的骨接触。其余的椎间盘保持在原位，并且一旦植入了两个假体部件就防止椎间假体侧向和/或前-后移动。
在优选实施例中，假体部件的长度H与其宽度B之间的比值是在3∶1和5∶1之间。这种设计的优点主要是，为了在椎间空间(椎间盘)中植入两个假体部件，只需要清理出宽度B和长度H的两条狭窄通路。
在另一个实施例中，椎间假体以两个构件实现，亦即帽状物与两个假体部件的其中之一制成一个构件。
在另一个实施例中，椎间假体以3个构件实现，从而使形成第三构件的帽状物可与两个假体部件的其中之一连接。这种设计的优点主要是在下述事实中看到，即板和帽状物可以用不同的材料实现，从而使它能对关节表面达到最佳滑动性能。对于板来说，优选材料是钛或钛合金及PEEK或有涂层的变体，而对帽状物来说，优选的材料是高交联聚乙烯(X-UHMWPE)、钴和铬的合金或陶瓷材料。
在另一个实施例中，椎间假体用至少3个构件实现，并包括有凹槽的关节壳体，因而上述关节壳体可作为第三构件附接到上述第一和第二假体部件的其中之一上。这种设计的优点主要是在下述事实中看到，即板和帽状物可以用不同的材料实现，从而对关节表面能达到最佳滑动性能。
在另一个实施例中，帽状物和关节壳体由金属和塑料制成的材料组合组成。这个实施例的优点是它能使用业已证明的关节替代材料的组合，例如高交联聚乙烯(X-UHMWPE)和钴与铬的合金。另一些优点是在下述事实中看到的，即对关节表面的相对位移可实现低摩擦力及可实现轴向冲击载荷的补偿。
在另一个实施例中，使用陶瓷-陶瓷关节。
在另一个实施例中，帽状物和凹槽的表面涂有碳化钛或无定形碳(ADLC)，用它们能显著降低摩擦系数。
在另一个实施例中，至少帽状物是用记忆金属或能溶胀的材料(例如水凝胶)制成。
在另一个实施例中，至少帽状物用可流动的热固性材料制成。单体、共聚用单体、均聚物、低聚物或含有这些热固性可流动的物质的混合物可以适当地从下面一组物质中选定：
a)聚乙二醇类，优选的是聚(双)丙烯酸乙二醇酯；
b)正乙烯基吡咯烷酮；
c)乙烯树脂，优选的是乙烯醇；和
d)苯乙烯。
这样得到的聚合物可以在它们的弹性方面广泛改变。这些设计的优点主要是在下述事实中看到的，即由于减小的关节体积，插入椎间假体变得侵害性较小，而增加的体积最适合于达到最佳关节功能。
在另一个实施例中，第一假体部件从第一套至少M≥2的第一假体部件中选定，而第二假体部件是从第二套至少N≥2的第二假体部件中选定。上述第一和第二套可以包括具有不同高度、关节半径或相应半径的中心的位置亦即旋转的中心的第一和第二假体部件。利用这个实施例，可以得到下列优点：
-因为两个部件部分可以用模块化方式布置，所以旋转中心的位置高度可调；
-各部件还可以改变帽状物的半径，这使它能调节椎间假体的旋转中心；
-椎间假体的旋转中心的位置、角度及平移运动的部分可以在较宽的范围内自由选定，平移运动的部分是横过假体部件的中心轴线测得的彼此相对运动的部分；
-假体部件还可以考虑运动段的关节要求，因为它能包括具有不同半径的帽状物。较大的帽状物半径在偏转期间有较高的平移运动的部分，这样在患者的脊柱的弯曲时把增加的压力放在小平面关节上，并导致其加速退化；
-假体部件的高度和相应的椎间假体的关节帽状物的半径可以改变，并因此可适用于不同椎间空间的尺寸。
按照本发明把椎间假体植入椎间空间中的方法包括以下步骤：
A)经由第一通路把第一假体部件横过椎间假体的中心轴线地植入到椎间区域中；
B)经由第二通路将椎间假体的第二假体部件横过椎间假体的中心轴线地植入到椎间区域中，所述第二通路与第一通路不同，因而两个假体部件当横过中心轴线测量时，各具有宽度B和长度H＞B及第一和第二假体部件的纵向轴线L1和L2，所述第一和第二纵向轴线L1和L2平行于长度H延伸，彼此相交成一角度α＞0；和
C)在植入期间用关节的方式将第二假体部件联接到第一假体部件上。
根据本发明的方法的实施例的类型，至少一个通路是经孔式地或外孔式地定位。经孔的通路在脊柱外科手术中已知并设立。由于经孔的通路，所以在对腹部或背部韧带或神经结构没有不利影响的情况下，朝椎间盘空间可以有大的开口。
在优选实施例中，两个通路设置在后面。
在另一个实施例中，第一凹槽经孔式地设置。
在另一个实施例中，第二凹槽外孔式地设置。
在另一个实施例中，位于两个椎体之间的空间中的椎间盘只移出到这种程度，以使设计用于抵靠到骨上的两个假体部件的整个接合表面与相应的椎体的端板有完全的骨接触。
在另一个实施例中，两个通路各具有一个进入点E，所述进入点E与矢状轴线间隔开，矢状轴线在中间朝前-后方向以这种方式延伸，以使两个植入的假体部件的纵向轴线L1和L2形成角度α。优选的是，角度α是在25°和120°之间的范围内。
附图说明
下面，将参照按照本发明的椎间假体的多个实施例的部分示意图更详细说明本发明及发明的改进。
在附图中：
图1是本发明的椎间假体的一个实施例的透视图；
图2是图1所示的本发明的椎间假体的实施例的上视图；
图3是图1所示的本发明的椎间假体的实施例的上视图，该图3与图2类似，但具有不同的角度α、不同的距离A和沿着矢状轴线10离位的交点S。
具体实施方式
图1所示的实施例主要包括椎间假体1，所述椎间假体1由具有矩形接合表面4、5的两个假体部件2、3组成。上述两个假体部件2、3具有长度H和宽度B，它们利用关节14可松开地相互连接。关节14由帽状物9和相应的凹槽11组成。在这个实施例中，帽状物9的半径大于假体部件3的宽度B，但小于上述假体部件3的长度H，长度H比宽度B长4到5倍。这种设计特点导致两个假体部件2、3的纵向轴L1、L2相对彼此具有不同的总体斜度，所述斜度取决于角α的大小(α＝在垂直于中心轴线6延伸的平面中纵向轴L1、L2之间的角度)。在角度α为90°时达到最佳的关节功能。在上述角度α为90°的情况下，倾斜的角度是角度α为0时二倍。
图2所示的实施例包括第一和第二假体部件2、3，所述第一和第二假体部件2、3是具有纵向轴线L1和L2及矢状轴线10的纵向构件。两个假体部件2、3的纵向轴线L1、L2有一交点S，并形成角度α。两进入点E之间的距离A和交点S因纵向轴线L1和L2所形成的不同角度α而有变动(图3和4)，上述进入点E相对于矢状轴线10对称设置，并标示将两个假体部件2、3插入椎间空间的点。
图3和4所示的两个横截面图各包括两个假体部件2和3，所述假体部件2和3都具有它们各自的纵向轴线L1和L2。由于纵向轴线L1和L2彼此相对位置的改变而产生不同的角度α，所以交点S沿着矢状轴线位移，而随着距离A增加，进入点E的位置保持不变。按照专门文献中所给出的评价，图3所示的变体与图4所示的变体相比是有利的，上述图3所示的变体具有一相对于椎体的端板的中心在后面设置的交点S，而上述图4所示的变体具有一相对于端板的中心在前面设置的交点S。
外科手术方法说明
下面，将参照图2说明能植入椎间假体1的外科手术方法。
a)在植入之前，如假体部件2、3的大小所要求的那样准备椎间盘。不用去除整个椎间盘，只需要清理出两条足够大的通路，以便椎间假体1的两个接合表面4、5可以与椎体的盖板直接接触。为此，只把椎间空间(椎间盘)去除到这种程度，以使两个假体部件的整个接合表面与它们各自的端板有骨接触。而其余的椎间盘保持在原位，并防止一旦植入两个假体部件2、3时椎间假体侧向移动。
b)在椎间盘中制备两个植入帽状物之后，经由两个后面/侧面通路12、13实施植入两个假体部件2、3。优选的是首先植入假体部件2、3中的一个，随后植入假体部件2、3中的另一个。两个对应的关节中心(帽状物9-凹槽11)一位于两个纵向轴线L1和L2的交点S中，就可以通过关节14使两个假体部件2、3相互连接，上述关节14由帽状物9和凹槽11组成。由于椎间盘部分在侧向上保持两个假体部件2、3，并使帽状物9和凹槽11联接，所以椎间假体1可靠地存留在椎间空间中。旋转中心位于中心矢状平面中，并可以前后变动，中心矢状平面是穿过患者身体前后延伸并在中心与身体相交的平面。
为了植入，可以使用两个经转孔或外孔通路12、13，上述经转孔或外孔通路12、13在脊柱外科手术中已知和形成。一旦实施了联接，则两个假体部件2、3形成一个单元，所述单元允许相邻的椎体的端板彼此相对倾斜。
由于椎间假体1的后植入技术，所以脊柱的腹部韧带结构保持原封不动，并且不削弱它们使脊柱稳定的功能。此外，原封不动的结构减少了椎间假体1的腹侧移动和危害脊柱区中腹部结构的危险。也可以在前面尤其是在较高的腰部及胸腰椎区中应用同样的外科治疗技术。解剖的环境严格地阻止前面插入，因为通路被主动脉和静脉腔妨碍。另外，在这种情况下，纤维环及前面纵向韧带的腹部结构保持原封不动。

Claims (14)

1.一种椎间假体(1)，包括：
A.第一假体部件(2)，所述第一假体部件(2)具有第一接合表面(4)和第一内表面(7)，上述第一接合表面(4)横过中心轴线(6)设置，用于接触第一邻接椎体的端板，而上述第一内表面(7)也横过中心轴线(6)设置，并具有球形凹槽(11)；
B.第二假体部件(3)，所述第二假体部件(3)具有第二接合表面(5)和第二内表面(8)，上述第二接合表面(5)横过中心轴线(6)设置，用于接触第二邻接椎体的端板，而上述第二内表面(8)也横过中心轴线(6)设置，并具有与上述凹槽(11)叠合的帽状物(9)；因而
C.第一和第二假体部件(2；3)可用帽状物(9)以关节的方式连接，所述帽状物(9)可滑动地接收在凹槽(11)中；
D.第一和第二假体部件(2；3)各具有横过中心轴线(6)的宽度B和长度H，上述第一和第二假体部件(2；3)还包括平行于各自的长度H延伸的纵向轴线L1、L2；因而
E.长度H大于宽度B，以便可以把假体部件(2；3)放入椎间空间内的一个位置中，当在垂直于中心轴线(6)的平面中伸出时在上述位置中的两个纵向轴线L1和L2彼此以角度α＞0°相交，
其中长度H与宽度B的比值是在3∶1和5∶1之间。
2.如权利要求1所述的椎间假体(1)，其中第二假体部件(3)和帽状物(9)由一个构件组成。
3.如权利要求1所述的椎间假体(1)，其中上述椎间假体(1)用至少3个构件得到，上述帽状物(9)是第三构件，可附接到上述第二假体部件(3)上。
4.如权利要求1或2或3所述的椎间假体(1)，其中上述椎间假体(1)用至少3个构件得到，并包括关节式壳体，所述关节式壳体包括凹槽(11)，该凹槽(11)可以作为第三构件附接到上述第一假体部件(2)上。
5.如权利要求4所述的椎间假体(1)，其中帽状物(9)和关节式壳体由金属和塑料配对的材料组成。
6.如权利要求4所述的椎间假体(1)，其中帽状物(9)和关节式壳体由配对的陶瓷-陶瓷材料组成。
7.如权利要求1或2或3所述的椎间假体(1)，其中帽状物(9和凹槽(11)的表面涂有碳化钛或无定形碳(ADLC)。
8.如权利要求1或2或3所述的椎间假体(1)，其中至少帽状物(9)是用记忆金属制成。
9.如权利要求1或2或3所述的椎间假体(1)，其中至少帽状物(9)是用能溶胀的材料制成。
10.如权利要求1或2或3所述的椎间假体(1)，其中至少帽状物(9)用可流动的热固性材料制成。
11.如权利要求10所述的椎间假体(1)，其中至少帽状物(9)用单体、共聚用单体、均聚物、低聚物或含有热固性可流动物质的混合物制成。
12.如权利要求11所述的椎间假体(1)，其中热固性可流动的物质从下面一组物质中选定：
a)聚乙二醇类；
b)正乙烯基吡咯烷酮；
c)乙烯树脂；和
d)苯乙烯。
13.如权利要求1或2所述的椎间假体(1)，其中上述第一假体部件(2)从至少M≥2的第一套第一假体部件(2)中选定，M为第一套第一假体部件的个数。
14.如权利要求1或2所述的椎间假体(1)，其中上述第二假体部件(3)从至少N≥2的第二套第二假体部件(3)中选定，N为第二套第二假体部件的个数。
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TW200724114A (en) 2007-07-01
ZA200704626B (en) 2008-09-25
US20080154383A1 (en) 2008-06-26
WO2006069465A1 (en) 2006-07-06
AU2005321738A1 (en) 2006-07-06
KR20070098801A (ko) 2007-10-05
ZA200704653B (en) 2009-09-30
KR20070098825A (ko) 2007-10-05
ATE549042T1 (de) 2012-03-15
CA2592421A1 (en) 2006-07-06
ATE475380T1 (de) 2010-08-15
CA2592505A1 (en) 2006-07-06

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