CN100588380C - 包括球缺形关节面的椎间植入物 - Google Patents

包括球缺形关节面的椎间植入物 Download PDF

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CN100588380C
CN100588380C CN03826779A CN03826779A CN100588380C CN 100588380 C CN100588380 C CN 100588380C CN 03826779 A CN03826779 A CN 03826779A CN 03826779 A CN03826779 A CN 03826779A CN 100588380 C CN100588380 C CN 100588380C
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joint
intervertebral implant
described intervertebral
parts
convex surface
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CN1802132A (zh
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B·莱希曼
R·比尔基
R·弗里格
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AO Technology AG
Synthes GmbH
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Synthes AG Chur
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Abstract

本发明涉及一种椎间植入物(1)，特别是人造的椎间盘，包括一条中心轴线(2)、一个上件(3)和一个下件(4)，其中：A)上件(3)具有一个上对合面(5)，其适用于贴靠到一个位于其上面的椎骨体的底板上；B)下件(4)具有一个下对合面(6)，其适用于贴靠到一个位于其下面的椎骨体的盖板上；C)两个件(3、4)中的一个包括一个具有一个第一关节面A的凸面的关节件(12)，而两个件(3、4)中的另一个包括一个具有一个在第一关节面A上可滑动支承的第二关节面B的关节壳(13)；以及D)凸面的关节件(12)和关节壳(13)构成一关节(9)，借其两个件(3、4)可绕至少一条转动轴线相互相对转动；其中E)其中一个件(3、4)包括至少一个连接装置(20)，借其将两个件(3、4)结合在一起，而不妨碍关节(9)的可转动性；并且F)连接装置(20)在关节(9)的任何的接合中允许在两个件(3、4)之间有一个轴向间隙X＞0。

Description

包括球缺形关节面的椎间植入物
技术领域
本发明涉及一种椎间植入物、特别是人造的椎间盘。
背景技术
在去除一个损坏的天然的椎间盘或一个损坏的椎间盘的髓核以后将现在的植入物插入两个邻接的椎骨体的椎间空隙。这样的植入物的植入的目的是，重新导致尽可能天然的状态，亦即特别是恢复原来的椎间盘高度并从而恢复两个邻接的椎骨体之间原来的间距。此外邻接的椎骨体的相互相对运动应该可尽可能无阻碍地以其天然的方式进行。为此在天然的限度内保持前倾/后倾、亦即椎骨体的屈曲和伸展时以及在椎骨体的侧向弯曲时的运动可能性是重要的。沿脊椎柱的天然的韧带和肌肉基本上是完整镇静的，从而这些进一步稳定机械的椎间盘代替物的运动。
由MARNAY氏的WO 01/01893已知一种这样的椎间植入物。该已知的植入物包括一个下盖板和一个上盖板以及一在两盖板之间设置的关节，其中两盖板的外表面可贴靠到邻接的椎骨体的盖板或底板上。该关节基本上包括一球缺形的第一关节件和一个互补的关节壳作为第二关节件，从而各盖板可相互相对多轴地转动。对该已知的椎间植入物不利的是，虽然两盖板各与一个关节件相连接，但关节件并从而整个的植入物在原位只能借助于专用的工具固定在一起。
由BERRY氏的US 5,895,428已知一种椎间植入物，其包括连接装置用以将各关节件固定在一起。对该已知的椎间植入物不利的是，各连接装置在两关节件的相对运动过程中也无间隙地相互滑动而不可能形成体液的润滑膜。
发明内容
在这里本发明将消除弊端。本发明的目的在于，提供一种椎间植入物，其具有一个可转动运动的关节，关节的各元件是可预组装的并且借助于连接装置有间隙地固定在一起，从而在各滑动面之间可以形成体液的润滑膜。
根据本发明，提出一种椎间植入物，包括一条中心轴线、一个上件和一个下件，其中A)上件具有一个上对合面，该上对合面适用于贴靠到一个位于其上面的椎骨体的底板上；B)下件具有一个下对合面，该下对合面适用于贴靠到一个位于其下面的椎骨体的盖板上；C)两个件中的一个包括一个具有一个第一关节面的凸面的关节件，而两个件中的另一个包括一个具有一个在第一关节面上可滑动支承的第二关节面的关节壳；以及D)凸面的关节件和关节壳构成一个关节，借其两个件可绕至少一条转动轴线相互相对转动，其中E)其中一个件包括至少一个连接装置，借其将两个件结合在一起，而不妨碍关节的可转动性；其特征在于，F)连接装置在关节的任何的接合中允许在两个件之间继而在第一关节面与第二关节面之间有一个轴向间隙X＞0；并且G)两个件在其对合面上设有宏观的结构。
根据本发明，连接装置包括一个可与两个件之一相连接而松动地支承于两个件中的另一个内的锚定元件。
根据本发明，凸面的关节件和关节壳由一种金属-塑料材料副构成。
通过本发明达到的优点可看出基本上在于，由于按照本发明的椎间植入物
-关节只具有一对关节面；
-可相互嵌接的连接装置在各关节件的相互相对转动运动过程中在生理需要的范围内总是具有间隙并从而并不阻碍各关节件的运动，
-在各滑动面之间可以形成体液的润滑膜并从而可达到对滑动面的较小的磨损或磨蚀；
-将椎间植入物固定在一起的各连接装置由几何上简单的元件构成；
-可达到低的制造成本；以及
-各关节件与盖板相连接，从而它们不可能移动和破坏周围的组织。
在一种优选的实施形式中，间隙X至少为0.005mm，优选至少为0.05mm。借此可达到的优点是，在各滑动面之间可以形成体液的厚度X的润滑膜。此外，借助于附加的暂时的固定装置可以简单地防止各关节面的损坏。
在另一种实施形式中，间隙X最大为0.5mm，优选最大为0.6mm。
在又一种实施形式中，连接装置包括一个锚定元件，其可连接于两个元件之一上并且松动地贴靠到两元件的另一个上。借此可达到连接装置的简单的实施形式并从而达到低的制造成本。
优选凸面的关节件具有一个空腔，其在凸面的关节件的想象的顶点处是敞开的，并且锚定元件在其中可轴向移动到使其在消除间隙X以后轴向贴靠在空腔壁上。借此也可达到连接装置的简单的实施形式并从而达到低的制造成本。
在另一种实施形式中，凸面的关节件包括一个球面的第一关节面A和关节壳包括一个与其互补的第二关节面B。通过关节面的球面的实施形式可达到的优点是，两元件可相互相对多轴地转动。
关节面的尺寸根据应用是不同的，其中在不同的实施形式中凸出球面的关节件的第一关节面A的半径在3mm与25mm之间，优选在4mm与20mm之间。
在又一实施形式中，凸面的关节件和关节壳由金属-塑料材料副构成。借此可达到的优点是：
-可采用已证明适用的关节代替物材料的组合，例如高度交联的聚乙烯(X-UHMWPE)和钴铬合金；
-在各滑动面的相对移动过程中可达到微小的摩擦力；以及
-可达到对轴向冲击载荷的阻尼。
在另一种实施形式中，关节面A、B涂覆碳化钛或非晶碳(ADLC)，借此显著地降低摩擦系数。
在又一种实施形式中，两个元件在对合面上涂覆钛层。
在另一种实施形式中，各对合面构成为凸面的并且匹配于邻接的椎骨体的天然的盖板表面或底板表面。
在又一种实施形式中，两个元件在其对合面上设有宏观的结构，其优选构成为许多突起部。
这些突起部在不同的实施形式中可以包括：
-角锥状的突起部；
-至少一个对称于中平面的楔状筋条，其沿一条前后的直线位于有关的对合面上；或
-对称中平面设置的锯齿状的齿。
通过这样的宏观结构的实施形式可达到的优点是，一方面可将转矩绕一条与对合面相交的转动轴线更好地从椎骨体传向椎间植入物，而另一方面可以增大骨在其上生长的面积。齿的优点是，其可以更好地穿入邻接的椎骨体的终板内。角锥状的突起部优选具有0.12mm3与1.4mm3之间的体积V。
在另一实施形式中，突起部至少部分地涂覆羟基磷灰石层或双相的羟基磷灰石-磷酸三钙混合物层，借此达到的优点是，两所述材料被完全结合于骨内或甚至由新的天然的骨组织取代。
根据应用在不同的实施形式中适用下列的几何形状及其随后的尺寸：
-空腔构成为同轴于中心轴线的圆柱形的；
-空腔具有6mm与20mm之间的直径D；
-空腔具有平行于中心轴线测量的在0.5mm与8mm之间的高度H；
-空腔具有一个同轴于中心轴线的收缩，其通入到凸面的关节件的关节面A内；
-收缩构成为同轴于中心轴线的圆柱形的；以及
-收缩具有一个直径d，其中比值d∶D在30％与75％之间。
附图说明
以下借助一个实施例的部分示意图还要更详细地说明本发明和本发明的进一步构成。其中：
图1本发明的椎间植入物的一个实施形式的剖面图；
图2图1中所示的本发明的椎间植入物的实施形式的前视图；
图3图1和2中所示的本发明的椎间植入物的实施形式的透视图；
图4图1至3中所示的本发明的椎间植入物的实施形式的分解图；
图5一椎间植入物的上件的透视图；
图6图5中所示的椎间植入物的实施形式的上件的侧视图；
图7另一椎间植入物的实施形式的上件的侧视图；以及
图8图7中所示的椎间植入物的实施形式的上件的脊部视图。
具体实施方式
图1至4中所示的本发明的椎间植入物1的实施形式基本上包括一个上件3、一个下件4和一个在两个件3、4之间设置的用于两个件3、4的铰接的关节9，其中，上件3具有一个与中心轴线相交的上对合面5，用以贴靠到上面邻接的椎骨体的底板上，下件4具有一个与中心轴线相交的下对合面7，用以贴靠到下面邻接的椎骨体的盖板上。关节9构成两部分的，其中凸面的关节件12构成球面部分并且与下件4相连接而互补于凸面的关节件12构成的关节壳13与上件3相连接。上件3和关节壳13在图中所示的实施形式中是两部分的，从而上件3例如可由钛或钴铬合金制造而关节壳13例如可由塑料制造。
凸面的关节件12同心于中心轴线2构成，并且其向上件3的下表面6的方向缩小。关节壳13也同心于中心轴线2设置，其中关节壳13的开口向下件4的上表面8的方向定向。将两个件3、4固定在一起的锚定元件15同轴于中心轴线2设置并且具有一个销16，该销以其后端25在关节壳的表面的想象的顶点30穿过关节壳13并且固定在上件3上，并且包括一个具有较大直径的圆盘形扩大部26，该扩大部设置在销16的前端27上。凸面的关节件12具有一个从其变窄侧进入的、与中心轴线2同轴的开口28，该开口通入到在凸面的关节件12的内部的具有较大直径的圆柱形空腔29内。锚定元件15以及开口28和空腔29的几何尺寸选择成使销16在开口28内和扩大部26在空腔29内可移动地设置。开口28的直径小于圆盘形板26的直径，使得凸面的关节件12和关节壳13继而使得在其上固定的两个件3、4被轴向结合在一起，而并不阻碍关节9的运动。销16在开口28内和板26在空腔29内的移动性能够实现两个件3、4相互相对多轴的可转动性。销16的长度确定成使在关节9的任何接合中扩大部26在销16的前端27处只有在消除间隙X以后才贴靠在开口28与空腔29之间的过渡上。
如图4中所示，两个件3、4各包括一个前侧的侧面31、41，各一个背侧的侧面32、42和各两个侧向的侧面33、34，43、44。此外，两对合面5、7构成为凸面的并且设有许多突起部18。中平面35位于侧向的侧面33、34，43、44之间的中心，其在这里也构成椎间植入物1的对称平面。此外，两对合面5、7包括两个平行的对称于中平面35设置的并且至少通入前侧的侧面31、41的凹槽39，其例如适用于容纳一个牵引工具(未示出)的臂。各突起部18在这里构成为角锥状的突起部38。
除图4中所示的角锥状的突起部38以外，在上对合面和下对合面5、7上的突起部18，如图5和6中所示，包括各一个楔状的比角锥状的突起部38增高的筋条36，其平行于一个在中平面35(图4)内的直线位于对合面5、7上。为了椎间植入物1可更好地插入椎间空隙内，筋条36的高度向背侧的侧面32的方向减小。
图7和8中示出突起部18的另一实施形式。相对于角锥状的突起部38增高的齿37部分地构成锯齿状的。其中较陡的齿侧面向前侧的侧面31的方向定向。其中各齿37位于一个在中平面35(图4)内的直线上并且从前侧的侧面31延伸到背侧的侧面32。
图5至8中分别只示例性示出上件3。突起部18包括角锥状的突起部38、一筋条36(图5和6)或齿37(图7和8)的同一实施形式可类似地转到下件4上。

Claims (24)

1.椎间植入物(1)，包括一条中心轴线(2)、一个上件(3)和一个下件(4)，其中
A)上件(3)具有一个上对合面(5)，该上对合面适用于贴靠到一个位于其上面的椎骨体的底板上；
B)下件(4)具有一个下对合面(6)，该下对合面适用于贴靠到一个位于其下面的椎骨体的盖板上；
C)两个件(3、4)中的一个包括一个具有一个第一关节面(A)的凸面的关节件(12)，而两个件(3、4)中的另一个包括一个具有一个在第一关节面(A)上可滑动支承的第二关节面(B)的关节壳(13)；以及
D)凸面的关节件(12)和关节壳(13)构成一个关节(9)，借其两个件(3、4)可绕至少一条转动轴线相互相对转动，其中
E)其中一个件(3、4)包括至少一个连接装置(20)，借其将两个件(3、4)结合在一起，而不妨碍关节(9)的可转动性；
其特征在于，
F)连接装置(20)在关节(9)的任何的接合中允许在两个件(3、4)之间继而在第一关节面(A)与第二关节面(B)之间有一个轴向间隙X＞0；并且
G)两个件(3、4)在其对合面(5、7)上设有宏观的结构。
2.按照权利要求1所述的椎间植入物(1)，其特征在于，间隙X至少为0.005mm。
3.按照权利要求1或2所述的椎间植入物(1)，其特征在于，间隙X最大为0.5mm。
4.按照权利要求1或2所述的椎间植入物(1)，其特征在于，连接装置(20)包括一个可与两个件(3、4)之一相连接而松动地支承于两个件(3、4)中的另一个内的锚定元件(15)。
5.按照权利要求4所述的椎间植入物(1)，其特征在于，凸面的关节件(12)具有一个空腔(29)，该空腔在凸面的关节件(12)的想象的顶点(30)处是敞开的，并且锚定元件(15)在其中可轴向移动到使其在消除间隙X以后轴向贴靠在空腔壁上。
6.按照权利要求1或2所述的椎间植入物(1)，其特征在于，凸面的关节件(12)包括一个球面的第一关节面(A)，而关节壳(13)包括一个与其互补的第二关节面(B)。
7.按照权利要求6所述的椎间植入物(1)，其特征在于，凸面的球缺形的关节件(12)的第一关节面(A)的半径在3mm与25mm之间。
8.按照权利要求7所述的椎间植入物(1)，其特征在于，凸面的球缺形的关节件(12)的第一关节面(A)的半径在4mm与20mm之间。
9.按照权利要求1或2所述的椎间植入物，其特征在于，凸面的关节件(12)和关节壳(13)由一种金属-塑料材料副构成。
10.按照权利要求1或2所述的椎间植入物(1)，其特征在于，关节面(A、B)涂覆碳化钛或非晶碳(ADLC)。
11.按照权利要求1或2所述的椎间植入物(1)，其特征在于，两个件(3、4)在对合面(5、7)上涂覆有钛层。
12.按照权利要求1或2所述的椎间植入物(1)，其特征在于，对合面(5、7)构成为凸面的。
13.按照权利要求1或2所述的椎间植入物(1)，其特征在于，宏观的结构是许多突起部(18)。
14.按照权利要求13所述的椎间植入物(1)，其特征在于，突起部(18)包括角锥状的突起部(38)。
15.按照权利要求13所述的椎间植入物(1)，其特征在于，
A)两个件(3、4)各包括一个前侧的和一个背侧的侧面(31、41，32、42)以及各两个侧向的侧面(33、34，43、44)；
B)一个中平面(35)位于侧面(33、34，43、44)之间的中心；以及
C)突起部(18)包括至少一个对称于中平面(35)的楔状的筋条(36)，筋条平行于一个在中平面(35)内的直线地位于有关的对合面(5、7)上。
16.按照权利要求13所述的椎间植入物(1)，其特征在于，
A)两个件(3、4)各包括一个前侧的和一个背侧的侧面(31、41，32、42)以及各两个侧向的侧面(33、34，43、44)；
B)一个中平面(35)位于侧面(33、34，43、44)之间的中心；以及
C)突起部(18)包括对称于中平面(35)设置的锯齿状的齿(37)。
17.按照权利要求14所述的椎间植入物(1)，其特征在于，一个角锥状的突起部(38)具有0.12mm3与1.4mm3之间的体积V。
18.按照权利要求13所述的椎间植入物(1)，其特征在于，突起部(18)至少部分地涂覆有羟基磷灰石层或一种双相的羟基磷灰石-磷酸三钙混合物层。
19.按照权利要求5所述的椎间植入物(1)，其特征在于，空腔(29)构成为同轴于中心轴线(2)的圆柱形的。
20.按照权利要求19所述的椎间植入物(1)，其特征在于，空腔(29)具有6mm与20mm之间的直径D。
21.按照权利要求19所述的椎间植入物(1)，其特征在于，空腔(29)具有平行于中心轴线(2)测量的在0.5mm与8mm之间的高度H。
22.按照权利要求5所述的椎间植入物(1)，其特征在于，空腔(29)具有一个同轴于中心轴线(2)的开口(28)，其通入到凸面的关节件(12)的关节面(A)内。
23.按照权利要求22所述的椎间植入物(1)，其特征在于，开口(28)构成为圆柱形的。
24.按照权利要求23所述的椎间植入物(1)，其特征在于，开口(28)具有一个直径d并且比值d∶D在30％与75％之间。
CN03826779A 2003-07-22 2003-07-22 包括球缺形关节面的椎间植入物 Expired - Fee Related CN100588380C (zh)

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CA2533473A1 (en) 2005-01-22
WO2005007040A1 (de) 2005-01-27
CN1802132A (zh) 2006-07-12
BR0318405A (pt) 2006-08-01
NZ544724A (en) 2010-03-26
US8133281B2 (en) 2012-03-13
ES2326877T3 (es) 2009-10-21
CA2533473C (en) 2011-03-15
EP1646336B1 (de) 2009-07-08
AU2003304352B2 (en) 2008-09-25
ATE435630T1 (de) 2009-07-15
CL2004001821A1 (es) 2005-05-06
JP2007504847A (ja) 2007-03-08
KR20060061337A (ko) 2006-06-07
DE50311697D1 (de) 2009-08-20
EP1646336A1 (de) 2006-04-19
US20060229725A1 (en) 2006-10-12
TWI321044B (en) 2010-03-01
TW200507795A (en) 2005-03-01
AU2003304352A1 (en) 2005-02-04
KR100973034B1 (ko) 2010-07-30
JP4299834B2 (ja) 2009-07-22
AR045072A1 (es) 2005-10-12

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