CN101351171A - 解剖学上的椎间盘定位架及其应用 - Google Patents

解剖学上的椎间盘定位架及其应用 Download PDF

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CN101351171A
CN101351171A CNA2006800482370A CN200680048237A CN101351171A CN 101351171 A CN101351171 A CN 101351171A CN A2006800482370 A CNA2006800482370 A CN A2006800482370A CN 200680048237 A CN200680048237 A CN 200680048237A CN 101351171 A CN101351171 A CN 101351171A
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locating rack
intervertebral disc
intermediate layer
multilamellar
disc locating
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热罗姆·勒维厄
帕特里克·托比阿诺
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Spineart SA
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Abstract

本发明涉及多层椎间盘定位架(1)，其具有至少三个叠置层——下层(3)、上层(2)、以及至少一个中间层(4)，所述至少一个中间层(4)用与下层(3)和上层(2)的材料不同的材料制成，且刚性较小，其特征在于，从俯视角度看，其具有菜豆籽的一般形状，且可由后入口或后侧入口植入。

Description

解剖学上的椎间盘定位架及其应用
本发明涉及解剖学上的椎间盘定位架及其应用。
目前，腰椎病用各种不同的方法治疗。
关节固定术在于紧固一个盘形件，以抑制两个相邻椎骨之间的活动。它们通过在两个椎体之间插入保持架加以实现。保持架是一种固体盒，其中央充填以松质骨。保持架的壁穿孔，以便与椎体融合。这种保持架在例如FR-A-2851457、FR-A-2736538、FR-A-2703580、FR-A-2816201、FR-A-2808673和FR-A-2790945中述及。但是，它们限制患者的活动范围。此外，它们增大相邻椎间盘的作用，从而引起其较快地磨损。
用前部植入法采用椎间盘假器的腰椎关节成形术，是弥补关关节固定术的缺陷的可供选择的办法。这里采用假器布置成替代椎间盘，构成与椎体接触的两个坪，其间放置一个中间部件，所述中间部件或者是一个球窝，或者是一个用弹性材料制成的部件。如果是具有球窝的系统，那么，上坪在其内表面具有与中间部件的球窝吻合良好的球面形状，以使脊柱正常活动。在用弹性材料制成的中间部件的情况下，是通过变形进行活动。
近来使用的这些技术具有恢复椎间盘活动的优越性。但是，其放置可能难度很大，甚至具有危险性。实际上，用前部植入法植入假器，要动主动脉和腔静脉，这可能很危险。此外，很多脊柱外科医生不习惯于前部植入法技术，必须由另一专科(例如血管科)的外科医生帮助，显然，这会增大成本，且无益于提高技能。
FR-A-2858546提出制成两部分的假器，其可用后部植入法植入。但是，假器的两个部分具有球窝部分，其中心必须重合，以使假器可正常工作。因此，这在植入时难以精确。
此外，如果在患者生存时两个部分之一即使略有变动，两个球窝部分就不再具有相同的中心，因此，组件不再工作。
另外，这种假器不能由后侧入口植入(TLIF式)。
此外，它不能减震。
AU-A-4238202也提出一种用后部植入法植入的假器。但是，其圆柱形形状不符合外科医生的习惯。另外，其稳定性成问题。实际上，如果不施行关节固定术，那么，患者在整个生存期间就要持续活动，因此，显然可担心时间一长会松开。
此外，这种假器不能由后侧植入。另外，它难以嵌塞在夹持椎间盘中。
因此，需要配设一个椎间盘定位架，其尤其可根据解剖学上的活动要求进行变形，不要求特殊的运动特性，且可由后入口或后侧入口植入。
不过，本申请人在长时间研究之后，提出一种由一个或两个部分制成的假器，其可由后入口或后侧入口植入，弥补了所述缺陷。
本发明在其最一般的实施例中提出多层椎间盘定位架，其具有两个构件，用于有效地锚固在椎坪上。这里，应当指出，本发明的装置针对后部定位架领域，而不是针对例如前部定位架领域。因此，前部定位架仅具有一个构件，一般来说，其宽度为25至40毫米，厚度为7至14毫米，长度为20至30毫米，而可由后入口或后侧入口植入的定位架，例如本发明的定位架，具有两个构件，它们由硬膜分开，一般来说，其宽度为8至12毫米，厚度为7至14毫米，长度为20至26毫米。本发明的菜豆形定位架不成对使用，其宽度约为10毫米，厚度为7至14毫米，曲线长度约为25至40毫米。
更确切地说，本专利申请涉及多层椎间盘定位架，其特征在于，它具有至少三个叠置层--下层、上层、以及至少一个中间层，所述至少一个中间层用与下层和上层的材料不同的材料制成，且刚性较小，其特征还在于，其具有适于由后入口或后侧入口植入的尺寸。
更确切地说，本专利申请涉及多层椎间盘定位架，其具有至少三个叠置层--下层、上层、以及至少一个中间层，所述至少一个中间层用与下层和上层的材料不同的材料制成，且刚性较小，其特征在于，从俯视的角度看，它具有菜豆籽的一般形状。
实质上，椎间盘定位架用于插入在两个椎骨之间。因此，通常，位于装假器的人的头部一侧的层称为“上”层。具有定向意义的其它用语，例如“前”和“后”或“上”和“下”，也是指保持架植入到装假器的脊柱中时的几何位置。
在实施本发明的优选条件下，上述多层椎间盘定位架仅具有一个中间层。
例如，至少一个中间层可用弹性材料制成，优选地，用弹性塑料制成，特别是用加聚或缩聚硅树脂塑料制成，或用聚氨酯塑料制成，尤其是用聚氨酯弹性材料制成，例如POLY MEDICA INDUSTRIES公司(马萨诸塞州)生产的商品
Figure A20068004823700061
中间层可仅用一种材料制成，或用两种材料的混合物制成，例如用硅树脂塑料和聚氨酯的混合物制成。
在实施本发明的其它优选条件下，至少一个中间层还具有一个或多个孔，其有规律地或无规律地分布在所述中间层中。因此，可以具有不同的减震类型，以适于所需的响应特性。
由于采用适当的厚度，至少一个中间层可再现关节的活动。例如，如果人朝前弯身，那么，位于L4和L5之间的椎间盘应向前挤压约2毫米；如果朝其右侧弯身，则该椎间盘应在其右侧部分挤压约1.5毫米。因此，弹性构件要具有所需的高度，以达到解剖学上活动所要求的最大优选幅度。弹性构件的所需高度也可以是解剖学上活动所要求的最大幅度的至少50％，有利地是至少70％，尤其是至少80％，特别是至少90％。
至少一个中间层的厚度可以是2至12毫米，优选地是3至11毫米，尤其是4至10毫米，特别是5至9毫米。
后面，在本专利申请中，至少一个中间层的所述一种或多种材料的刚度以其硬度表示。
至少一个中间层的所述一种或多种材料的硬度例如可以是40肖氏硬度至60肖氏硬度，优选地是50肖氏硬度至55肖氏硬度，特别是25肖氏硬度至45肖氏硬度，尤其是30肖氏硬度至40肖氏硬度。
可以将至少一个中间层的所述一种或多种材料的厚度选择、硬度选择与孔的形状和尺寸选择结合起来，以获得所需的减震效果。
至少一个中间层可以在其厚度上分层，且接纳插入件，所述插入件尤其是用与所述至少一个中间层的构成材料不同的另一弹性材料制成。该插入件也可以通到外部，从而构成附加中间层。插入件的弹性材料通常比所述至少一个中间层的构成材料更具挠性(或相反更具刚性)。
下层和上层形成板，其用坚固的材料制成，优选地，可用钛制成，且有利地，在表面配有涂层，尤其是单独的或配以羟磷灰石的多孔钛涂层。通常，其外表面最好开槽或带齿，以使本发明的椎间盘定位架长期具有基本稳定性。
在实施本发明的其它优选条件下，多层椎间盘定位架首先插入在两个椎骨之间的一侧，在垂直剖面上具有细长形状或纺锤形状，例如呈锥体形状或呈炮弹形状。
在实施本发明的其它优选条件下，上述多层椎间盘定位架所具有的一般形状接近长方形平行六面体，在这种情况下，如果成对使用，从俯视角度看，则具有菜豆籽的形状。
本发明的多层椎间盘定位架尤其可以用复制模在形成下层和上层的板之间制成，所述板在内部具有凹凸不平的表面。
本发明的多层椎间盘定位架具有非常引人注目的特性和质量。
由于其弹性中间层，它容许定位不精确，且根据解剖学上的活动要求进行变形。
在两个球形表面之间存在接触的假器会产生完美的转动运动。因此，该系统具有髌骨连接的运动特性。不过，在正常活动时，椎间盘具有转动和平移相结合的无规则的运动。本发明的椎间盘定位架中的弹性材料可使定位架如同身体需要那样变形，而无需强制固定的路径。本发明的椎间盘定位架不要求特殊的运动特性。
此外，它们可减震。
本发明的具有接近平行六面体的一般形状的椎间盘定位架的形状，与待嵌塞保持架的形状相同。在这种情况下，在硬膜的每一侧植入两个定位架。这种定位架可以按照与用于待嵌塞腰椎保持架的技术相同的技术，用后部植入法植入。
本发明的从俯视角度看具有菜豆籽一般形状的椎间盘定位架，可以按照与菜豆籽形保持架的植入技术相同的后侧植入法植入。在这种情况下，仅植入一个定位架。
本发明的优选椎间盘定位架的入口区域的炮弹形状便于夹持椎间盘之间的植入。
如同在与椎坪接触的区域和/或含或不含羟磷灰石涂层的多孔钛涂层上实施的齿那样，下层和上层的外部结构使本发明的椎间盘定位架立刻和长期具有极好的稳定性。
本发明的配有各种不同形状和尺寸的孔和/或使用不同的弹性材料以构成中间层的椎间盘定位架，可获得各种不同的减震效果。
这些特性下面在实验部分予以说明。它们证明上述定位架用于通过椎间盘假器的腰椎关节成形术。
因此，本专利申请最后涉及采用椎间盘假器的腰椎关节成形术的方法，其中，在需要采用椎间盘假器施行腰椎关节成形术的人的两个椎骨之间，嵌入至少一个上述的多层椎间盘定位架。
参照附图，本发明将得到更好的理解，附图如下：
图1、2、3和4是本发明的椎间盘定位架的立体图；
图5是本发明的定位架的俯视图，该定位架呈如图3所示的菜豆形，处于两个椎骨之间的其最终植入位置；
图6是图1、2和4所示的本发明的两个定位架的正视垂直剖面图，其也植入在两个椎骨之间；以及
图7至16是本发明的配有不同类型的孔的定位架的垂直剖面图。
如图1所示，应当注意，所示的椎间盘定位架1具有三层，即上层2、下层3、以及中间层4，所述上层2由具有开槽表面的钛板构成，所述下层3具有相同的结构，所述中间层4在所示的模型上由硬度为35肖氏硬度的聚氨酯构成(POLY MEDICA INDUSTRIES公司(马萨诸塞州)生产的商品名为
Figure A20068004823700081
的聚氨酯弹性材料)。
可以看出，椎间盘定位架1的一般形状是长方形平行六面体的形状，但是，如图左部所示，其端部之一呈纺锤形。这种形状可更容易地插入到两个夹持椎骨之间。
在这里所示的模型上，中间层4的厚度在椎间盘定位架的整个结构上是不变的。
上钛板2和下钛板3逐渐变细，以获得所需的骨架。
图2上基本上可以看到与图1上相同的特征，但是，中间层4不具有不变的厚度，而是随着接近纺锤形端部逐渐增大厚度。
图1和2所示的定位架成对使用，如同后面图6所示。
相反，图3所示的模型如果单独使用，则如图5所示。在该图3所示的椎间盘定位架上，可看到与图1上基本相同的构件，但是，从俯视图看，其一般形状不是长方形平行六面体的形状，而是菜豆籽的形状。
图4所示的模型是图2所示的模型的一个实施例。但是，中间层4由两种不同的材料组成且分开。实际上，插入件5所用的材料不同于构成同钛板2和3接触的中间层4的材料。在第一实施例中，插入件5用较具刚性的塑料制成。相反，在另一实施例中，插入件用刚性较小的材料制成。在第三实施例中，插入件是用钛制成的插入件。
在所示的模型中，插入件5在侧边上容易直接接近，但是在椎间盘定位架1的用于首先插入到两个椎骨之间的部分处，不通到外部，如图左部所示。
图5示出图3所示类型的椎间盘定位架1植入就位。箭头示出外科医生将椎间盘定位架1插入到两个椎骨之间的方向。
图6是图1所示类型的两个定位架的正视垂直剖面图，所述定位架植入在两个相邻的椎骨5、6之间。附图中央示出硬膜7。
图7至16示出本发明的具有各种各样的孔的定位架。对于图7至11所示的定位架来说，这些孔为复式，且基本上对称地分布在定位架中。
在图12所示的定位架上，定位架的纵向端部基本上不配有中间层，因为存在一个通到外部的孔。对图15和16来说是一样的。
采用图7和8所示的定位架，会获得定位架的均匀变形。
采用图9所示的定位架，中央的变形较大，从而增大吸震能力。
采用图10所示的定位架，两个叠置孔增大等负荷变形。
采用图11所示的定位架，每一侧较大的孔增大弯曲和伸长变形能力。
采用图12所示的定位架，端部的材料凹口有利于增大弯曲和伸长变形能力。
采用图13所示的定位架，孔不对称地进行布置，以有利于弯曲和伸长。
采用图14所示的定位架，仅在一侧布置的孔有利于弯曲和伸长。如果孔布置在后侧上，则有利于伸长，如果孔布置在前侧上，则有利于弯曲。
采用图15和16所示的定位架，将均匀变形与仅一侧有凹口结合起来，以有利于弯曲或伸长。如果凹口布置在后侧，则有利于伸长，如果布置在前侧，则有利于弯曲。

Claims (9)

1.多层椎间盘定位架(1)，其特征在于，它具有至少三个叠置层--下层(3)、上层(2)、以及至少一个中间层(4)，所述至少一个中间层(4)用与下层(3)和上层(2)的材料不同的材料制成，且刚性较小，其特征还在于，其具有适于由后入口或后侧入口植入的尺寸。
2.根据权利要求1所述的多层椎间盘定位架，其特征在于，从俯视角度看，它具有菜豆籽的一般形状。
3.根据权利要求1或2所述的多层椎间盘定位架，其特征在于，多层椎间盘定位架(1)的首先插入到两个椎骨之间的侧边在垂直剖面上具有细长形状或纺锤形状。
4.根据权利要求1至3中之一所述的多层椎间盘定位架，其特征在于，所述至少一个中间层(4)还具有一个或多个孔，其有规律地或无规律地分布在所述中间层(4)中。
5.根据权利要求1至4中之一所述的多层椎间盘定位架，其特征在于，它仅具有一个中间层(4)。
6.根据权利要求1至5中之一所述的多层椎间盘定位架，其特征在于，所述至少一个中间层(4)用弹性材料制成，例如用弹性塑料、加聚或缩聚硅树脂塑料、或聚氨酯塑料制成。
7.根据权利要求1至6中之一所述的多层椎间盘定位架，其特征在于，所述至少一个中间层(4)的厚度为3至11毫米。
8.根据权利要求1至7中之一所述的多层椎间盘定位架，其特征在于，所述至少一个中间层(4)的所述一种或多种材料的硬度为50肖氏硬度至55肖氏硬度。
9.根据权利要求1至8中之一所述的多层椎间盘定位架，其特征在于，所述至少一个中间层(4)在其厚度上分层，且接纳一个插入件(5)。
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CN106955174A (zh) * 2016-11-30 2017-07-18 重庆润泽医药有限公司 一种弹性椎间融合器
CN110368147A (zh) * 2019-08-05 2019-10-25 北京爱康宜诚医疗器材有限公司 椎间融合器及其制备方法
CN112891030A (zh) * 2021-03-22 2021-06-04 四川大学华西医院 专用于颈椎曲度反弓的颈椎椎间高度维持器和其制造方法

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JP2009519800A (ja) 2009-05-21
EP1981443A2 (fr) 2008-10-22
BRPI0620110A2 (pt) 2011-11-01
WO2007077319A2 (fr) 2007-07-12
ES2367766T3 (es) 2011-11-08
BRPI0620110B8 (pt) 2021-06-22
KR20080085050A (ko) 2008-09-22
FR2894808A1 (fr) 2007-06-22
KR101323775B1 (ko) 2013-10-29
BRPI0620110B1 (pt) 2018-03-06
EP1981443B1 (fr) 2011-06-15
WO2007077319A3 (fr) 2007-08-30
US20090093885A1 (en) 2009-04-09
CA2634326A1 (fr) 2007-07-12
FR2894808B1 (fr) 2009-02-06
ATE512644T1 (de) 2011-07-15
JP5209493B2 (ja) 2013-06-12

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