CN1545398A - 脊椎之间的假体 - Google Patents

脊椎之间的假体 Download PDF

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CN1545398A
CN1545398A CNA018235522A CN01823552A CN1545398A CN 1545398 A CN1545398 A CN 1545398A CN A018235522 A CNA018235522 A CN A018235522A CN 01823552 A CN01823552 A CN 01823552A CN 1545398 A CN1545398 A CN 1545398A
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prosthese
counterpart
protuberance
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vertebra
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CN1271974C (zh
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克劳德·马蒂厄
ϣ
贝亚特·莱希曼
保罗·帕夫洛夫
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AO Technology AG
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Synthes AG Chur
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A61B17/7068—Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; Tools therefor

Abstract

脊椎之间的假体(1)具有一个能插入脊椎之间区域的具有一个中心轴线(4)的中间部分(2)、一个内端(7)和一个外端(8)以及两个在外端伸出的、相对于中心轴线(4)沿半径方向和直径方向延伸的突出部(3)，突出部(3)能插入两个相邻的脊椎骨体的棘突之间的区域，中间部分(2)在其背向突出部(3)的内端(7)上有一个轴向的凹槽(5)，用于容纳一个基本上与假体(1)对称的配合件(6)。

Description

脊椎之间的假体
技术领域
本发明涉及一种按照权利要求1前序部分的脊椎之间的假体，一个假体的配合件以及由它们组合成的多部件的脊椎之间的假体。
这样的假体被用作为损坏的椎间盘的两个相邻的脊椎骨体之间的间距保持器，否则这两个脊椎骨体之间的间距就会缩小。通过使间距重新变大，混乱的关节的负载也被减小。
背景技术
由WO99/42051已知一种这样的脊椎之间的假体，这种假体具有一个插入椎间空间的中间件，在中间件的右边和左边有从中间部分伸出的前和后各一对耳朵，把中间件-在实现植入后-固定在两个相邻的脊椎骨体的棘突(Dornfortsatz：突起的棘部)之间的区域内。
这种已知假体的不利之处是它的一体性，这增加了植入的困难，使得必须拆除脊椎上的韧带。拆除这条韧带来了其他的缺点，即假体在背面没有可靠的支持物。由于这个原因在WO99/42051中建议，为假体在脊椎之间的中间件钻一个通孔，以便在其中穿过一根带子，用这根带子能够把假体固定在相邻脊椎骨体的棘突上。这些是耗时和复杂的。
以上对现有技术的讨论只是为了解释本发明范围，并不意味被引用的现有技术在本申请或其优选权的时间实际上已经公布或为公众所知。
发明内容
在这里本发明将予以帮助。本发明的任务是，创造一种脊椎间的假体，这种假体能在保留脊椎上的韧带的条件下被植入，使手术总体上节省地实现，并且保证不需要附加的装置保证背面植入的安全性。
本发明通过一个多部件的脊椎之间的假体来解决这个提出的任务，在此各个部件可能具有不同的机械特性。
根据本发明的脊椎之间的假体基本上包括一个能插入脊椎之间区域的中间部分，此中间部分具有一个中心轴线和两个在外端伸出的、相对于中心轴线沿半径和直径方向延伸的突出部，此突出部能插进两个相邻的脊椎骨体的棘突之间的区域。在中间部分上在其背对着突出部的内端上有一个轴向的凹槽，它用于容纳一个基本上与假体对称的配合件。
在优选实施形式中，中间部分具有连接件，用这个连接件能把配合件固定在假体上。这个连接件具有这样的性能，即，在连接件固定时相互确定突出部在假体上的位置和突出部在配合件上的位置。最好连接件由具有一个挡块的卡口式连接构成，使在配合件固定在假体上时突出部在假体上和配合件上占据它们所希望的位置。可以用一个螺栓连接或锥面连接代替卡口式连接把两个部件相互固定在一起，在这种情况下，假体和配合件最好有一个扭转锁定件，使配合件只能在一个确定的位置插入假体的轴向凹槽中。连接件的另外一种构造由至少一个能弹性变形的凸块构成，这个凸块在假体和配合件组合之后能锁定或卡锁在其上。
在按照本发明假体的另外一个优选实施形式中连接件具有至少一个能够弹性变形的凸块，这个凸块在假体和配合件组合时能弹性变形，并且在假体和配合件组合后能啮合到一个互补的凹槽中。
一个优选的进一步构造在于，与中心轴线垂直的横截面：
a)通过中间部分在它的最窄处在内端区域具有50到300mm2，最好是70到250mm2的面积；以及
b)通过突出部的面积为70到500mm2，最好是100到450mm2。
此外假体最好用弹性材料制造，使中间部分在径向上能弹性变形。通过用塑料制造假体或带有径向能弹性变形的簧片的中间部分的构造能够达到足够的径向弹性变形能力。
假体可以用人造橡胶、硅树脂或由聚碳酸酯族制成的聚合物制造。如果借助于合适的机械装置能实现假体在位于脊椎空间中的中间部分区域的弹性，也有可能用金属材料制造假体。
在按照本发明假体的另外一个实施形式中假体构成为空心的，空腔壁能缩陷和/或能通过填充空腔而膨胀。能缩陷的空腔壁具有以下优点，假体由此能够产生较大的变形，就像它是弹性材料允许的那样。
在内端区域内中间部分的外表面可以构成为光滑的或粗糙的。通过外表面的构造能够影响骨头的生长，在此粗糙的外表面促进骨头在假体上生长，而光滑的外表面使这种生长变困难或完全阻止这种生长。可以通过埋入羟磷灰石(HA)保护与骨头接触的植入体表面。
在优选实施形式中按照本发明的配合件具有一个内端、一个外端以及在两个外端上伸出的同样在半径和直径方向上延伸的突出部，这两个突出部能被放入两个相邻的脊椎骨的棘突之间的与假体相对的空间。此外在配合件上向着内端有一个能插入假体上的凹槽中的榫部。因此在植入时能把假体和配合件准确地对准。
如假体一样配合件可以配备有类似的彼此互补的连接件。连接件也可以是卡口式连接、能弹性变形的凸块或者螺栓连接同样还有锥面连接。在配合件上同样可以设有一个类似的彼此互补的扭转锁定件。
按照本发明的带有配合件的椎间假体的优选实施形式的特点在于，它在组合状态下具有一垂直于中心轴线的对称面，其中椎间假体的突出部和配合件的突出部从平行于中心轴线的方向看有一个至少2mm的间距，最好是至少3mm的间距。脊椎之间的假体的突出部和配合件的突出部的最大间距为15mm，最好是12mm。
附图说明
在下面借助多个实施例的部分示意图对本发明和本发明的进一步构成进行更加详细的解释。附图中：
图1a  示出按照本发明的带有配合件的脊椎之间的假体的优选实施形式的一个截面；
图1b  在图1a中示出的按照本发明的带有配合件的假体的侧视图；
图2  按照本发明的带有配合件的脊椎之间的假体的另外一个优选实施形式的一个截面；
图3  按照本发明的带有配合件的脊椎之间的假体的又另外一个优选实施形式的一个截面；
图4  按照本发明的带有配合件的脊椎之间的假体的另外一个优选实施形式的一个截面；
图5  按照本发明的带有配合件的脊椎之间的假体的另外一个优选实施形式的一个视图。
具体实施方式
在图1中示出了在组合状态下的带有配合件6的脊椎之间的假体1。假体1的中间部分2以假体1的内端7与配合件6邻接。在假体1的外端8上两个突出部3垂直于中心轴线4，并且在直径方向上相对地设置。突出部3在所示的实施形式中被设计成一个椭圆状体的一半。配合件6的同样在半径方向上和在直径方向上相互相对的突出部3被对称地设置在一个与中心轴线4垂直的平面上。三个径向的并在假体1与中心轴线4平行的方向看的横截面上对称设置的凸块17(Nocken)用作为假体1和配合件6之间的扭转锁定件(Verdrehungssicherung)，凸块17在中间部分2上在假体1的内端7上突出并且嵌入在配合件6上的互补的槽18中。中间部分2有一个与中心轴线4同轴的凹槽5，凹槽5从内端7深入假体1的深度为T。配合件6有一个与凹槽5互补配合的并且在假体1和配合件6组合时能插入槽5中的榫部(Zapfen)16。假体1还有一个带有能够贴合在假体1外端8上的螺钉头26的固定螺钉19。固定螺钉19可与中心轴线4同轴地穿过假体1，并且能借助一个卡口式连接27被锁定在配合件6的榫部16上，从而使假体1和配合件6可拆开地被锁住。固定螺钉19和配合件6被一个与中心轴线4同轴的孔20穿透，使假体1和配合件6能在径向上缩陷(kollabierbar)。
图2示出在组合状态下的带有配合件6的假体的另外一个实施形式。凹槽5从内端7到外端8同轴地穿过假体1。配合件6的榫部16在假体1和配合件6组合时被推入贯通的凹槽中一直到假体1的内端碰到配合件6的突出部3。配合件6在外端15和内端14之间还贯穿有一个孔20。连接件11被做成螺栓连接，在此螺栓21通过假体1上的凹槽5并通过配合件6上的孔20从假体1的外端8伸到配合件6的外端15，并且能用螺母22锁住。此外假体1有一个空腔12，使空腔壁13能可选择地缩陷或用填充材料充填空腔12而膨胀。
在图3中示出的实施形式与上述的实施形式的不同之处在于，配合件6上的榫部16完全穿过假体上的凹槽5，使配合件6的内端14和假体1的外端8对齐。配合件6还有多个从内端14贯穿到外端15的通孔20，这些孔20的轴线与中心轴线4平行。用于固定脊椎之间的假体1和配合件6的环扎丝(Cerclagedraht)23能穿过这些孔20。
在图4中示出的实施形式与在图1中示出的实施形式的不同之处仅在于，连接件11有一个能穿过与中心轴线4同轴的贯穿假体1和配合件6的孔20的锁紧螺栓28。锁紧螺栓28的头29能够贴靠在配合件6的外端15上，并且在它的顶端有能径向变形的凸块31，凸块31在组合好的假体1和配合件6时能嵌入一个其直径大于孔20直径的尾孔(Hinterdrehung)30，使假体1和配合件6保持在一起。为了把锁紧螺栓28插进孔20，凸块31能够借助于轴向设置的槽32垂直于中心轴线4压缩，使锁紧螺栓28穿过孔20，而在组合状态下凸块31弹性回弹，并且啮合在假体1上的尾孔30中。锁紧螺栓28有与中心轴线4同轴的通孔，这样能插入销钉25，由此阻止凸块31沿径向向内弹性变形。
在图5中示出按照本发明的带有配合件6的假体1的另外一个实施形式。在假体1外端8以及配合件6外端15上设置有垂直于中心轴线4并在直径方向上相互相对的突出部3，在这个实施形式中突出部3具有与中心轴线4平行的一个半圆形横截面。凹槽5从内端7到外端8与中心轴线4平行地穿过假体1。在凹槽5内设有非常大螺距的内螺纹36。配合件6又有一个邻接内端14的榫部16，榫部16有与内螺纹36互补配合的外螺纹33，这样假体1和配合件6能够用这个螺栓连接可拆卸地相互固定在一起。在榫部16和突出部3之间在配合件6上有一个第一锯齿状的齿部34，齿部34在假体1与配合件6组合时能与在假体1内端7上的一个互补配合的第二齿部35啮合，这样通过齿部34、35的不对称构造形成防止假体1和配合件6的非故意松开的保险装置。

Claims (32)

1.一种脊椎之间的假体(1)，它具有一个能插入脊椎之间区域的具有一个中心轴线(4)的中间部分(2)、一个内端(7)和一个外端(8)以及两个在外端(8)伸出的相对于中心轴线(4)沿半径方向和直径方向延伸的突出部(3)，该突出部(3)能插入两个相邻的脊椎骨体的棘突之间的区域，其特征在于，中间部分(2)在其背向突出部(3)的内端(7)上有一个轴向的凹槽(5)，用于容纳一个基本上与假体(1)对称的配合件(6)。
2.按照权利要求1所述的假体(1)，其特征在于，中间部分(2)有连接件(11)，用连接件(11)能把配合件(6)固定在中间部分(2)上。
3.按照权利要求1或2所述的假体(1)，其特征在于，与中心轴线(4)垂直的通过中间部分(2)的横截面(9)在内端(7)区域在中间部分(2)最窄处(10)具有50到300mm2，最好是70到250mm2的面积。
4.按照权利要求1至3之一所述的假体(1)，其特征在于，通过突出部(3)的垂直于中心轴线(4)的横截面具有70到500mm2，最好是100到450mm2的面积。
5.按照权利要求1至4之一所述的假体(1)，其特征在于，假体(1)用一种弹性材料制造，中间部分(2)在其最窄处(10)的直径的弹性变形允许为相对于未收负荷的直径的10-60％，最好是15到50％。
6.按照上述权利要求1至5之一所述的假体(1)，其特征在于，假体(1)由肖氏硬度为65A-90A的塑料构成。
7.按照权利要求1至5之一所述的假体(1)，其特征在于，假体(1)由一种金属材料构成，并且中间部分(2)具有能在径向弹性变形的簧片。
8.按照权利要求1至7之一所述的假体(1)，其特征在于，假体(1)构成为空心的，其空腔壁(13)能选择地缩陷或通过用填充材料填充空腔(12)而能膨胀。
9.按照权利要求1至8之一所述的假体(1)，其特征在于，中间部分(2)在其内端(7)区域其外表面构成为光滑的。
10.按照权利要求1至8之一所述的假体(1)，其特征在于，中间部分(2)在其内端(7)区域其外表面构成为粗糙的。
11.按照权利要求1至10之一所述的假体(1)，其特征在于，至少在假体(1)表面的一部分在假体材料中埋入羟磷灰石(HA)。
12.按照权利要求2至11之一所述的假体(1)，其特征在于，连接件(11)包括卡口式连接(27)。
13.按照权利要求2至11之一所述的假体(1)，其特征在于，连接件(11)具有能弹性变形的凸块(31)，该凸块(31)在假体(1)和配合件(6)组合之后能锁定在配合件上。
14.按照权利要求13所述的假体(1)，其特征在于，连接件(11)设有一个与中心轴线(4)同轴的孔(20)，假体(1)有一个能插入孔(20)中的销钉。
15.按照权利要求2至11之一所述的假体(1)，其特征在于，连接件(11)包括一锥面连接。
16.按照权利要求2至11之一所述的假体(1)，其特征在于，连接件(11)包括一螺栓连接。
17.按照权利要求13至16之一所述的假体(1)，其特征在于，假体(1)包括一个能容纳在配合件(6)中的扭转锁定件。
18.按照权利要求1所述的假体(1)，其特征在于，中间部分(2)的轴向凹槽(5)由贯穿整个中间部分的通孔构成。
19.按照权利要求1至18之一所述的假体(1)，其特征在于，从平行于中心轴线(4)的方向看突出部(3)的横截面是半圆面。
20.用于按照权利要求1至19之一所述的假体(1)的配合件(6)，其特征在于，
A)配合件(6)有一个内端(14)、一个外端(15)；
B)两个在外端(15)伸出的相对于中心轴线(4)沿半径方向和直径方向延伸的突出部(3)，该突出部(3)能插入两个相邻的脊椎骨的棘突之间的区域，以及
C)朝向内端(14)有一个能插入假体(1)凹槽(5)的榫部(16)。
21.按照权利要求20所述的配合件(6)，其特征在于，榫部(16)包括能把假体(1)固定在配合件(6)上的连接件(11)。
22.按照权利要求21所述的配合件(6)，其特征在于，连接件(11)包括一卡口式连接。
23.按照权利要求21所述的配合件(6)，其特征在于，连接件(11)具有能弹性变形的凸块，该凸块在假体(1)和配合件(6)组合之后能锁定在配合件上。
24.按照权利要求21所述的配合件(6)，其特征在于，连接件(11)包括一锥面连接。
25.按照权利要求21所述的配合件(6)，其特征在于，连接件(11)包括一螺栓连接。
26.按照权利要求22至24之一所述的配合件(6)，其特征在于，假体(1)包括一个能容纳在配合件(6)中的扭转锁定件。
27.按照权利要求22至26之一所述的配合件(6)，其特征在于，从平行于中心轴线(4)的方向看一突出部(3)的横截面是半圆面。
28.带有一配合件(6)的脊椎之间的假体(1)，其特征在于，假体(1)在组合的状态下有一个与中心轴线(4)垂直的对称面。
29.按照权利要求1至19之一所述的脊椎之间的假体(1)，它有一个按照权利要求20至26之一所述的配合件(6)。
30.按照权利要求28或29所述的带有一配合件(6)的脊椎之间的假体(1)，其特征在于，脊椎之间的假体(1)的突出部(3)与配合件(6)的突出部(3)具有一个至少2mm，最好是至少3mm的间距。
31.按照权利要求28至30之一所述的带有一配合件(6)的脊椎之间的假体(1)，其特征在于，脊椎之间的假体(1)的突出部(3)与配合件(6)的突出部(3)具有一个最大15mm，最好是最大12mm的间距。
32.按照权利要求28至31之一所述的带有一配合件(6)的脊椎之间的假体(1)，其特征在于，脊椎之间的假体(1)具有一个第一扭转锁定件，配合件(6)具有一个与第一扭转锁定件互补的第二扭转锁定件，使脊椎之间的假体(1)的突出部(3)和配合件(6)的突出部(3)能进入一个相互对齐的位置。
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CN102802546A (zh) * 2009-06-12 2012-11-28 凯丰有限责任公司 棘突间植入物和使用方法
CN102802546B (zh) * 2009-06-12 2015-02-04 凯丰有限责任公司 棘突间植入物和使用方法
CN102283703A (zh) * 2011-04-06 2011-12-21 柳昌和 脊椎棘突间距保持装置
CN102283703B (zh) * 2011-04-06 2014-06-11 柳昌和 脊椎棘突间距保持装置
WO2017101599A1 (zh) * 2015-12-15 2017-06-22 宁波华科润生物科技有限公司 棘突间固定系统
US10624681B2 (en) 2015-12-15 2020-04-21 Ningbo Hicren Biotechnology Co., LTD Interspinous process bracing system

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SK1002004A3 (en) 2004-08-03
TW534811B (en) 2003-06-01
WO2003015645A1 (de) 2003-02-27
CA2495119C (en) 2010-02-02
US7442208B2 (en) 2008-10-28
EP1418852A1 (de) 2004-05-19
CN1271974C (zh) 2006-08-30
CA2495119A1 (en) 2003-02-27
JP2004537389A (ja) 2004-12-16
US20040199255A1 (en) 2004-10-07
CZ2004212A3 (cs) 2004-06-16
JP4947879B2 (ja) 2012-06-06

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