CN1158979C - 可扩张骨接合套 - Google Patents

可扩张骨接合套 Download PDF

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Publication number
CN1158979C
CN1158979C CNB971978913A CN97197891A CN1158979C CN 1158979 C CN1158979 C CN 1158979C CN B971978913 A CNB971978913 A CN B971978913A CN 97197891 A CN97197891 A CN 97197891A CN 1158979 C CN1158979 C CN 1158979C
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implant
arm
implant according
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Expired - Fee Related
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CNB971978913A
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CN1230880A (zh
Inventor
大卫·阿塔里
ˡ�Ф��
让－卢克·肖万
大卫·阿蒂亚
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Caga Concept LLC
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Caga Concept LLC
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Abstract

本发明涉及一种可扩张骨接合植入物，它具有一些臂(5)，每个臂在一端与一个基座(7)相连，基座钻有一个孔(8)，该植入物适于从两个相邻椎骨的相对表面之间的后方放入，以使它们保持一定距离，以恢复脊柱的稳定性。根据本发明，所述臂(5)和基座(7)限定一个中空套(1)，套在“初始”位置时呈准圆柱形的总体外形，具有准圆形截面，套(1)的朝向臂(5)末端的内部容积(9)的至少一部分呈准圆截锥形，其大底部朝向基座(7)，所述植入物具有至少三个臂(5)，并且在内部容积(9)内具有至少一个分隔器(2)，所述分隔器适于穿过孔(8)和截锥形大底部。

Description

可扩张骨接合套
本发明涉及一种可扩张骨接合套。
本发明的技术领域是可植入的骨植入物或假体以及使用这些骨植入物或假体的外科技术的技术领域。
本发明的主要应用是提供用于从后部方向插入到两个相邻椎骨的相对表面之间的植入物，以便在其间保持一定的距离，并且例如在相应的关节衰竭之后，通过将两个椎骨固定在一起，恢复脊柱的稳定性。
目前有几种技术，通过植入一个及时使椎骨融合在一起的移植物、或者植入一个立即将椎骨固定在一起的假体，同时仍然可以及时在椎骨之间进行融合，以恢复“正常的”腰椎前突。
在另一种上述技术中，主要使用还称为“套”的植入物，有些套为中空刚性整件，具有内/外互通槽，以接纳一个骨移植物，随后，骨移植物通过槽与两侧邻接的椎骨融合在一起。在该领域中，可参阅1996年3月21日公开的WO96/08205“圆锥形锥间融合套”以及1995年2月8日公开的EP637440“体内脊柱植入物”。但是，这类套的外部尺寸是给定的和固定的，而椎骨对之间的距离却不是恒定不变的。另外，要给予一定角位置的相对椎骨表面的斜度不能使刚性套从后部方向加以使用，只能从前部方向进行插入。
因此，已经研制出其它类型的套，这些套具有两个基本平行的臂，这两个臂与一个刚性壳体相连接，可使一个蜗杆螺钉系统进行转动，然后使螺钉上啮合的一个楔从接近两个臂末端的初始位置朝着使这两个臂连在一起的壳体移动，从而使两个臂呈一定角度张开。然后，可以将这种最初呈平坦形状的套插入椎骨之间，接着，通过转动楔的驱动轴，调节臂间所需角度或者从后部入口进行设置。
这种套或植入物在例如1995年8月2日公开的EP664994的“体内椎骨套”或者1995年11月17日公开的EP2719763的“椎骨植入物”中有所描述。
但是，这种机械程度比中空刚性套高、因而比较复杂的装置留给融合移植物的内部容积较小，而且因为其形状不是圆形对称形状，即使它们在椎骨间能够更好地确保一定的方位角，也要求准备一条接纳它们的、具有相同矩形截面的通道，而这会使手术复杂化。
因此，提出的问题是要能够使植入物或套同时既具有一个普通刚性套的形状，首先便于植入，其次具有较大的内部容积，又可以在植入之后，使套末端的直径增大到一定数值，该数值相当于其位于外科植入点附近的端部的直径，并相应于椎骨后部表面的直径，而又具有尽量少的机械构件。
解决该问题的一种办法是可扩张的骨接合植入物，这种植入物具有一些臂，每个臂在一端与一个基座相连，该基座钻有一个孔，所述臂和基座构成一个中空套，这种套处于“初始”位置时，具有圆柱形或准圆柱形的总体外部形状，围绕其对称轴线旋转而形成这种形状的母线或者是一条直线，或者具有一段弯曲的中间部分、例如半径大的凸圆弧形，并且具有母线围绕其运行的一条准曲线，因此还限定准圆柱形的截面，这提供了一种圆柱体，或者是一种正圆柱体，或者是一种在本案中称为“卵形”或“椭圆形”的圆柱体，以下称为圆柱体或准圆柱体；套的朝向臂末端的内部容积的至少一部分呈准圆截锥形，其大底部朝向基座，植入物具有至少三个臂和至少一个分隔器，处于初始位置时，分隔器的尺寸与内部容积中截锥形大底部的尺寸相适应，并且适于穿过所述孔。
处于“工作”位置时，分隔器使臂张开，所述内部容积呈圆柱形，套的外形呈近似截锥形，一旦分隔器置于所需位置，就没有任何内部构件保留在由臂、分隔器和孔限定的空间内。
“初始”位置和“工作”位置的定义分别由图1、3A、4A、5A、9、10、11和图2、3B、3C、4B、5B示出。“初始”位置是植入物安置就位之前的位置，当植入物安置就位时，即在套内的臂之间没有固定分隔器时，套具有截面不变的圆柱形外部容积。“工作”位置是植入物在例如两个椎骨之间的最终位置，其臂由置于最终调节位置的分隔器张开，套的总体外形为近似截锥形，从基座张开，与植入物朝其外科植入点的端部、朝其较深地安放在椎骨之间的末端相适应。
为了使套更好地固定在骨中，为了避免以后套的移动，臂的外表面最好进行滚花、铣槽或采用具有凸纹的螺纹型面加工螺纹。
同样，为了减小植入后的套发生转动和移动的危险，并同时增大与椎骨表面的接触面积，至少植入物的基座、最好还有臂的侧边具有至少两个可以是平行的平坦部分，每个平坦部分围绕植入物的轴线对称地布置在两个相邻的臂之间。这些平坦部分，可借助套的总体卵形形状，由于减小了植入物发生转动的危险，使得扩张后能得到更好的固定。此外，所述卵形形状能够比静止时套的基本圆柱形形状的外部母线是一条直线更好地使套在扩张后返回到圆锥形而无弯曲部分的外部轮廓，从而对椎骨体产生分布较好的推力，帮助骨移植物发挥更好的作用。
为了在其后端加强所述套，特别是如果基座上有大孔，从而在套安放就位和扩张之后易于使骨质充填所述套，基座的孔要适于接纳一个用于对套的内部容积加以封闭的插塞。作为例子，插塞可以旋进孔中，孔加工有螺纹。在这种情况下，插塞防止骨质的失散，根据制造插塞的材料，它还可以对套起到加强作用。
各种实施例示于以下的附图中。结果是新型的可扩张骨接合植入物可解决所提出的问题，对于上述主要应用来说尤其如此。
配置至少四个臂，或者四至八个臂，使得可以进行双向扩张，从而更好地压紧椎骨的两个相对的表面，如果在保持所述扩张的分隔器和端座上的孔或插塞之间不设置连接件或杆，则可确保有较大的内部容积，以接纳大量骨质，从而增进愈合和融合，特别是要使之连接在一起的椎骨之间的融合。由于在套的后端具有一个穿过基座的大孔，所述充填手术变得更为容易。
另外，由于所述孔的缘故，可以通过骨接合套底部表面和顶部表面上的位于臂之间的槽刮削椎骨的表面。
而且，上述扩张系统非常简单，因为只包括两个构件，即分隔器和套(可以具有一个位于其端部的插塞以及还可以具有一个如下所述的中间分隔器)，而安装后则无连接件，因为用于固定分隔器和插塞的任何杆或轴随后被除去。
因此，本发明比前述的一些现有的植入物或套具有许多优越性，它还具有其它一些优越性，但是，上述优越性已足以表明本发明的新颖性和实用性。
说明书和下面的附图给出本发明具有四个臂的植入物的两个非限制性实施例，在不超出本发明范围的情况下还可以有其它一些实施例，例如具有三个臂或四个臂以上的实施例。
附图如下：
图1是一个实施例中处于“初始”位置的植入物的立体图，其各构件处于一条公共安装轴线XX’上。
图2是图1所示植入物处于“工作”位置时的立体图，三个构件装配在一起。
图3A、4A和5A分别是一个套的一个剖视图和两个轴向侧视图，一个是套的前表面侧视图，另一个是套的后表面侧视图，示出处于“初始”位置的另一个植入物实施例。
图3B、4B和5B是图3A、4A和5A所示的同一个套的相同的视图，但是套的互补构件组装在一起，处于“工作”位置。
图3C是与图3、4和5所示实施例中处于“工作”位置的植入物的垂直于轴线的侧视图。
图6、7和8是本发明植入物的套的细部图。
图9、10和11分别是图1和2所示实施例中植入物的一个局部侧视图和两个示出前表面和后表面的轴向视图。
图12、13和14分别是图1、2、9、10和11所示实施例中一个非螺纹端部分隔器、图3、4和5所示实施例中一个螺纹端部和/或中间分隔器、以及本发明任一实施例中一个封闭插塞的正视图和剖视图。
无论怎样的实施例，可扩张的骨接合植入物通常都包括一些臂5，每个臂在一端与一个基座7相连，基座7钻有一个孔8。根据本发明的一个主要特征，臂5和基座7构成一个中空套1，套1在图1、3A、4A和5A以及图9、10和11所示出的“初始”位置时，一般呈圆柱形或准圆柱形的总体外形，其截面也是呈圆柱形或准圆柱形的准曲线，连接所述准曲线并通过围绕其对称轴线XX’进行移动而形成圆柱形或准圆柱形的母线或者是一条直线，或者是一个大半径的凸圆弧形，这或者提供一个如图3A中实线201所示的圆形对称的正圆柱体，或者提供一个在该情况下称为“卵形”或“椭圆形”的准圆柱体，即呈略微凸起的外形，如图3A中虚线202所示。套1的朝向臂5末端的内部容积9的至少一部分呈准圆对称的截锥形，其较大的底部距离基座7较近，其植入物具有至少四个臂5和至少一个分隔器2，分隔器适于穿过孔8，并通过截锥形的大底部进入内部容积9。
如图2、3B、4B、5B和3C所示，即在“工作”位置，端部分隔器2使臂5张开，然后，内部容积9呈圆柱形，而套1的外形呈近似截锥形。例如如图3B所示，实线201示出从一个处于初始位置的规则基圆柱体获得的略微凸起的形状，而虚线202示出从一个初始为椭圆形的圆柱体而获得的比较直的形状，如图3A所示。一旦分隔器2安置在所需位置，用于使植入物和分隔器安置就位的内部构件就不留在由臂5、分隔器2和孔8所限定的空间内。
不管怎样的实施例，臂5的至少一部分外表面加工有具有凸纹的螺纹轮廓11，如图7所示。特别是，根据实施例，对于长度L约为20毫米至25毫米的一个套来说，臂5的螺纹部分的长度1可为13毫米至16毫米，螺距P为1.5毫米至2毫米，套的圆柱体的外径D为9毫米至16毫米，对于相邻螺纹牙之间的螺纹角β约为60°来说，螺纹牙111高约为0.7毫米至0.9毫米，螺纹内部牙型112的半径约为0.4毫米。牙型的圆形形状使应力集中最小，从而可以经受大的作用力和冲击。
因此，这种具有凸纹的外螺纹便于安装，因为插入植入物时，是旋入已经用同植入物的孔8相一致的工具所开的孔中，所以不会发生冲击，不会受损伤，一旦安置就位，这种螺纹还确保固定在骨中，从而避免以后的任何移动。
基座7可包括至少两个平坦部分6，这两个平坦部分彼此平行或者彼此略微倾斜，更为紧密地与椎骨的外形相贴合，每个平坦部分布置在两个相邻臂5之间，如图1、2、9、10和11所示。基座7也可以具有四个平坦部分，形成正方形或准正方形截面，如图3、4和5中的实施例所示。除了基座之外，臂5本身也可以具有各自的平坦部分，臂5的平坦部分至少要与基座的平坦部分相一致，如图3至5中的实施例所示，如果植入物的截面为准圆形，则尤其如此，也可以不设置平坦部分，如图1、2以及9至11中的实施例所示。这些平坦部分可以由如上所述的略呈卵形或椭圆形的植入物纵向截面代替，或者至少与之相连。
基座7的孔8可以加工有螺纹15，如图6中的实施例所示，螺纹15具有螺脊和螺槽皆为圆形的螺距，为了与上述实施例所给出的尺寸相联系，一个孔8可以具有7毫米至10毫米的内径d、1毫米至1.5毫米的螺距P’、约0.6毫米的螺纹深度以及约30°的螺纹牙壁间的螺纹角γ。
然后，用于封闭内部容积9的一个插塞3旋进孔8，用作一个植入物安装杆的一个固定点，或者在植入物安置就位、端部分隔器2使臂张开之后，插塞3旋进孔8，封闭内部容积9，以便首先是加强所述套，其次是防止已经植入到套内的任何骨质穿过所述后端。
这种插塞3示于图14A的正视图和图14B的侧视图，具有图6所示的螺纹152以及一个多边形中央孔17，该孔为正方形、六边形等，或者由任何适于固定一个杆端的构件代替，所述杆具有一个相适应的端部，以便使插塞旋进旋出。
另外，在植入物的后表面上和基座7的孔8周边上，可以形成一些销或槽，用于围绕杆固定一部分“辅助”安装件，使套1、分隔器和/或插塞3能够加以推动，以便植入物安置就位时使植入物的定位更为牢固，并且便于拆除辅助件而无需移动植入物。
在具有四个臂5的实施例中，套1具有四个槽10，形成臂间空间，如图8所示，图8例如是沿图9中箭头VIII的视图。这种槽首先用于增进内部容积9中的骨质与相邻椎间盘的融合，其次在植入物安装期间，使臂5进行更好的变形，这一特殊部分的臂的截面小于其端部的截面。另外，这种槽可以是长椭圆形，其朝向臂5末端的端部比其相对的端部窄，如图8所示。并且终止于所述臂的一对对相邻臂的末端之间的一条狭缝101。一旦套扩张以后，至少对于主槽10来说，这种形状可以形成一个具有平行边缘的槽。另外，选用这种形状的轮廓代替图3A所示的宽度不变的一种槽，可以增大分隔器2和套臂5末端之间的支承面面积，从而提供更大的强度。
在图1、2、9、10和11所示的实施例中，限定套1内部容积9的一些臂5的内表面是平滑的，因此，该容积在其末端包括一个轴向腔室12，适于接纳分隔器2，如图12所示，并且适于通过一个凸肩13保持分隔器，该凸肩的直径大于处于工作位置的套的内部容积9的直径，如图1所示。
分隔器2具有一个轴向螺纹孔14，适于接纳一个杆，至少杆端也加工有螺纹，并且适于只要施加推力并进行平移就可使分隔器安装就位，安装杆随后予以拆除。
如图1和2所示，为了避免套1的壳体由于相邻椎骨的压力而在大应力下、在其靠近臂5末端的前端发生变形而围绕分隔器2滑移、使臂一个朝向另一个移动的危险，可以使分隔器配置至少两个键18或其它构件，它们围绕植入物的轴线XX′对称布置。这种分隔器在植入物安置就位之前，从臂端进入而安放在套1内；或者基座7具有至少两个相应槽19，当安放该分隔器时，如果分隔器2需要通过基座插入，槽19允许两个键18沿其进行滑移，键的宽度e不大于两个相邻臂5末端之间的间距。
该装置可包括其它系统，使臂在扩张后不变形，例如在臂端一个槽中装一个外环，臂可使之变形。
在图3、4和5所示的实施例中，限定套1内部容积9的臂5的内表面加工有螺纹，螺距相当于基座7的孔8的螺距，例如如图6所示，分隔器2相应地加工有螺纹，如图13A和13B所示。
在该具有内螺纹的实施例中，套1也可以包括至少另一个中间分隔器4，该中间分隔器如同端部分隔器2那样加工有螺纹，可以在它后面旋入，以便首先压缩植入在两个分隔器之间的空间中的骨质，其次加强套的中央部分。
端部分隔器2和中间分隔器4分别具有轴向多边孔16，这些孔适于接纳一个可拆卸杆，该杆具有一个形状相适应的凸形端部，以便安装这些分隔器时对它们进行推动。
套1的内部容积9的截锥形形状可以具有例如6°至9°的半倾角α。

Claims (13)

1.一种可扩张的骨接合植入物，它具有一些臂(5)，每个臂在一端与一个基座(7)相连，基座钻有一个孔(8)，其特征在于，所述臂(5)和基座(7)构成一个中空套(1)，这种套处于“初始”位置时，呈准圆柱形的总体外形，具有准圆形截面，套(1)的朝向所述臂(5)末端的内部容积(9)的至少一部分呈准圆截锥形，其大底部朝向所述基座(7)，所述植入物具有至少三个臂(5)，并且在所述内部容积(9)内具有至少一个分隔器(2)，所述分隔器与截锥形大底部的尺寸相适应，一旦分隔器(2)置于所需位置，在由所述臂(5)、分隔器(2)和孔(8)所限定的空间内就不保留任何内部构件。
2.根据权利要求1所述的植入物，其特征在于，处于“工作”位置时，所述分隔器(2)使所述臂(5)张开，所述内部容积(9)趋于圆柱形，而套(1)的外形趋于近似截锥形。
3.根据权利要求1所述的植入物，其特征在于，所述臂(5)的至少一部分外表面加工有具有凸纹的螺纹轮廓(11)。
4.根据权利要求1所述的植入物，其特征在于，基座(7)具有至少两个平坦部分(6)，每个平坦部分布置在两个相邻臂(5)之间。
5.根据权利要求1所述的植入物，其特征在于，基座(7)的孔(8)适于接纳一个插塞(3)，用于封闭套(1)的内部容积(9)。
6.根据权利要求1所述的植入物，其特征在于，限定套(1)内部容积(9)的臂(5)的内表面是平滑的，所述容积在其末端具有一个轴向腔室(12)，适于接纳所述分隔器(2)，并且适于通过一个凸肩(13)保持所述分隔器，该凸肩的直径大于处于“工作”位置的套的内部容积(9)的直径。
7.根据权利要求6所述的植入物，其特征在于，所述分隔器(2)包括一个轴向螺纹孔(14)，适于接纳一个可以拆除的安装杆，至少杆端也加工有螺纹并且是相适应的。
8.根据权利要求7所述的植入物，其特征在于，所述分隔器(2)包括至少两个键(18)，它们围绕植入物的轴线对称布置，键的宽度(e)不大于两个相邻臂(5)末端之间所需的间距。
9.根据权利要求1所述的植入物，其特征在于，限定套(1)内部容积(9)的臂(5)的内表面加工有螺纹，所述分隔器(2)相应地也加工有螺纹。
10.根据权利要求9所述的植入物，其特征在于，所述套(1)具有至少一个第二中间分隔器(4)，这种中间分隔器如同端部分隔器(2)那样加工有螺纹。
11.根据权利要求10所述的植入物，其特征在于，所述分隔器(2，4)分别具有轴向多边形孔(16)，适于接纳一个可拆卸杆，该杆具有一个形状相适应的凸形端部，以便推动所述分隔器并使之安装就位。
12.根据权利要求1至11之一所述的植入物，其特征在于，套(1)的总体外形呈圆柱形，通过围绕其对称轴线XX′旋转而形成所述圆柱形的母线具有一个弯曲的中间部分，使套呈卵形。
13.根据权利要求12所述的植入物，其特征在于，所述中间部分是一个具有大半径的圆弧形部分。
CNB971978913A 1996-09-13 1997-09-12 可扩张骨接合套 Expired - Fee Related CN1158979C (zh)

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