CN101330884A - 用于对椎骨进行固定和体内融合的保持架 - Google Patents

用于对椎骨进行固定和体内融合的保持架 Download PDF

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CN101330884A
CN101330884A CNA2006800457970A CN200680045797A CN101330884A CN 101330884 A CN101330884 A CN 101330884A CN A2006800457970 A CNA2006800457970 A CN A2006800457970A CN 200680045797 A CN200680045797 A CN 200680045797A CN 101330884 A CN101330884 A CN 101330884A
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plate
retainer
stud
hole
disengagement
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CN101330884B (zh
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热罗姆·勒维厄
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Spineart SA
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Abstract

一种用于对椎骨进行固定和体内融合的系统，包括至少一个保持架和一个与所述保持架的主平面垂直地邻近的板，其中，所述板(1)和所述保持架(2)具有孔(21)和双头螺栓(12)，所述双头螺栓(12)能够插入所述孔21中并可释放地锁定于所述孔21中，通过简单的拖拉和拆卸装置即可将板(1)移除，一种成套工具包括所述用于对椎骨进行固定和体内融合的系统以及所述拆卸装置。

Description

用于对椎骨进行固定和体内融合的保持架
本发明涉及用于对椎骨进行固定和体内融合(intersomatic fusion)的保持架，以及该保持架的应用，还涉及一种拆卸装置。
用于对椎骨进行固定和体内融合的系统应用于颈椎棘突的外科手术中。这些系统基于被称为椎骨间保持架的假体的使用，用于当椎间盘弱化时，重新建立两个相邻椎骨之间解剖学上的距离。通过安装在保持架内的骨移植物的生长，该保持架使椎骨在椎间空间内相对固定。
例如，文献FR-A-2 8514 57、2 736 538、2 816 201、2 808 673和2 790 945描述了包括至少一个保持架的用于对椎骨进行固定和体内融合的系统。
一种改进的移植物是专利文献FR-A-2 747 034中描述的保持架/板装配。该系统包括开口的内部保持架，并允许放置骨移植物或者放置促进体内融合的材料，以促使所涉及的两个椎骨的融合，所述内部保持架容纳松质骨并趋向于设置在两个椎骨之间。在该系统中描述的保持架包括位于其前表面的外部元件，该外部元件形成板，所述板在与位于保持架任一侧的导入平面基本垂直的平面内延伸。在保持架的两端，具有用于固定在将相互连接的至少两个相邻椎骨上的装置。该装置确保了保持架的定位和不移动。外部板可制造在内部保持架中，或者这两个元件也可分开制造，之后再由连接装置连接在一起。这些连接装置使保持架/板装配“锁定”，这种锁定使外科医生不能轻易地将其拆卸。这是因为，当欲拆下这块板时，必须将其以平行于所述保持架的前表面所在的平面的方式平移，而被称为最小入侵技术的最近的手术技术在所述板的周围未留有允许这种平移的空间。
也可能发生这种情况，位于颈椎棘突的前部的板的长期存在给病人带来不便。
因此，期望有这样一种用于对椎骨进行固定和体内融合的系统：其允许板被轻易移除，但将保持架仍留在适当位置，尤其是不需要首先以平移的方式移动它。
对外科医生而言，能够选择用于固定板的螺钉的植入位置、以及在未能植入螺钉的情况下能够选择在另一个位置重新植入另一个螺钉也将是有利的。
因此，期望有这样一种用于对椎骨进行固定和体内融合的系统：其允许外科医生将板自由地定位于椎骨体上。
经过漫长的研究之后，申请人开发了一种保持架，在这种保持架中，保持架/板装配的装配更为容易。此外，在某些实施方案中，只要螺钉没有植入椎骨体内，该板就能够自由地转动。
正是为了这个目的，本申请的主题是用于对椎骨进行固定和体内融合的系统，包括至少一个保持架和一个板，所述板设置为与所述保持架的主平面垂直，所述系统的特征在于，所述板和所述保持架中的一个具有孔，而另一个具有能够插入所述孔并被可逆地封锁于所述孔内的双头螺栓(stud)，所述板能够通过简单的拖拉而移除。
保持架可具有各种形状，尤其是圆柱形、截头圆锥体形或平行六面体，其优选地由钛、PEEK(聚醚醚酮)或任何生物相容的材料制成。该保持架包括确定锥间空间的前表面、后表面、左表面和右表面，还包括上部和下部的开口表面。
板优选地具有大体呈平面的平行六面体或椭圆形形状。其有利地为细长的，并且尤其由钛、不锈钢或任何其它的生物相容的材料制成。
为了确保板在相邻椎骨上的固定，该板包括大体朝向其两端中每一端的孔，所述孔允许用植入椎骨体内的螺钉将所述板固定。
根据本发明的一种实施方案，保持架包括双头螺栓，而板包括孔。然而，按照本发明的优选实施方案，保持架包括孔，而板包括双头螺栓。
当保持架包括孔而板包括双头螺栓时，孔将有利地位于保持架的前侧面。用于这部分的双头螺栓将有利地位于朝向板的各端的孔之间。相反，当保持架包括双头螺栓而板包括孔时，双头螺栓将有利地位于保持架的前侧面，而孔将有利地位于朝向板的各端的孔之间。
双头螺栓可插入或可逆地封锁于所述孔内，并允许所述板相对于保持架旋转。该双头螺栓可对应于平行六面体形状的凸起，但其优选地为圆柱形的或内接于圆柱体内部。当该双头螺栓为圆柱形或内接于圆柱体内部时，板更易于相对于保持架旋转。
双头螺栓和孔的相对的形状和尺寸使得，双头螺栓可插入孔内并在拖拉上锁定。例如，圆柱形的双头螺栓能与圆柱形的孔配合，但也可与例如立方形或六边形的形状配合。
在本发明的优选实施方案中，双头螺栓具有用于将所述双头螺栓封锁于所述孔内的系统，尤其是由在所述双头螺栓的端部升起的凸缘(优选地为圆柱形)形成的系统，或由位于双头螺栓的端部的销钉形成的系统，或者是由优选的有利于将双头螺栓导入孔内的锥形轴环形成的系统，该锥形轴环位于沿着双头螺栓的长度的中部。当双头螺栓具有由有利于将双头螺栓导入孔内的锥形轴环形成的系统时，孔内具有供所述轴环插入的槽。而该槽的一个壁将倾斜，以允许通过拖拉而将板抽出。
根据本发明的一种实施方案，孔的内侧是经轧边的，以使得当凸缘位于所述双头螺栓的端部时，可通过拖平而将板抽回。
在实现本发明的优选条件下，双头螺栓为中空的，尤其是中空圆柱形的，并具有纵向裂口，该纵向裂口使得双头螺栓具有弹性性质。因此，当将双头螺栓引入孔内时，双头螺栓的壁元件能够朝向彼此地接近，以允许这种引入，然后恢复其原始的配置，以便在完成引入之后就实现封锁。
根据本发明的再一种实施方案，板上具有双头螺栓，且双头螺栓的内部具有用于允许将拆卸装置固定的固定系统，如下文所述。该固定系统可包括例如槽，尤其是螺纹。
还可提供具有孔的保持架和板，以及连接片。连接片具有例如优选地为圆柱形销的形状，例如设计为与双头螺栓类似。
有利地，保持架在其至少一个侧面上包括至少一个开口，该开口允许保持架在个人日常生活的运动过程中发生变形，从而将刺激造骨细胞生长的机械压力传递给位于所述保持架内部的移植物。
有利地，位于左侧面和右侧面的开口是基本对称的，并且在具有多个裂口的情况下，其可为交替的、堆叠的或倾斜的水平裂口的的形式。上述开口还可为对齐或不对齐的平行立面体形状或优选地为圆形的连续的或间隔的孔，或者为由纵向槽连接的孔的形式。这些开口具有双重功能，即，允许移植物形成血管，并使保持架具有期望的变形性能。在这种情况下，保持架优选地由PEEK制成。
本发明还涉及一种上述系统的拆卸装置，包括安装于管内并配备有手柄的轴杆，所述管的一端具有桥状物，所述桥状物上装配有两个相间隔的支腿，用于放置于板的各侧并制成所述保持架，所述轴杆的一端具有用于固定板或双头螺栓的构件，所述轴杆能够在所述管内纵向移动。
根据本发明的一种实施方案，所述轴杆能够滑动，并在远离其具有紧固装置的端部具有杆，该杆在被驱动时允许所述轴杆纵向移动，使得双头螺栓能解锁，并通过简单的拖拉将板抽出。
根据本发明的另一种实施方案，所述轴杆的一端具有螺纹，并与成形于管上的接合部共同工作。通过螺纹连接至所述双头螺栓的内螺纹和通过管而封锁平移，所述轴杆允许施加拖拉，用于将双头螺栓解锁并将板抽出。桥状物可沿所述轴杆具有内螺纹，以更好地引导轴杆。
根据本发明的再一种实施方案，通过在所述轴杆的端部提供钩子，以钩在所述板上，而将所述板紧固。
在实现本发明的优选条件下，所述轴杆的远离所述手柄的端部具有螺纹，而双头螺栓上具有可与所述轴杆的该端部配合的内螺纹。在与支撑在保持架上的“支腿”的配合工作中，该系统使得双头螺栓可被解锁，且板将通过简单的拖拉而被抽出。
本发明还涉及一种包括上述系统和上述拆卸装置的成套工具。
本发明还涉及一种包括上述系统、上述拆卸装置、以及用于将板螺纹连接于椎骨上的螺钉的成套工具。
本发明主题的上述包括保持架和板的、用于对椎骨进行固定和体内融合的系统以及该装置的拆卸装置具有非常有利的性质和质量。
该系统尤其允许在将保持架保持于适当位置的同时将板更容易地抽出，而不必例如首先将其平移移动。并且，由于可以转动，因而其允许外科医生将板自由地定位于椎骨体上。
在下面的实验部分示出这些性质。它们证明在颈椎棘突的外科手术中，采用上述的用于对椎骨进行固定和体内融合的系统及其拆卸装置是正确的。
根据本发明的固定系统还可包括两个或多个包括上述的保持架和板的系统，这些系统通过所述板相互连接，并可成对地相互重叠也可不重叠。
使用上述用于对椎骨进行固定和体内融合的系统及其拆卸装置的优选条件也适用于上述的本发明的其它主题，尤其适用于包括它们的成套工具。
通过参考附图，可更好地理解本发明，其中：
图1示出了保持架和板在拆开时的立体图，并在局部剖视图中使出了双头螺栓的放大细节；
图2示出了保持架和板装配在一起时的立体图；
图3示出了用于拆卸板的装置的立体图；
图4示出了用于拆卸板的装置的剖视图；
图5示出了在向板施加拉力之前，用于拆卸板的装置的端部的立体图；以及
图6示出了在向板施加拉力之后，用于拆卸板的装置的端部的立体图。
方向性的措词如“前”和“后”、“顶部”和“底部”或“上部”和“下部”是指将保持架植入待治疗的脊柱时，保持架的朝向。因此，在图1中，前侧壁位于右上方，而后侧壁位于左下方。
如图1所示，根据本发明的系统包括板1和保持架2。
图1中示出的保持架2具有大体为平行六面体的形状，并且关于通过脊柱的主轴线的前后平面对称。保持架2具有前侧壁22和后侧壁23。
前侧壁22和后侧壁23由右侧壁25和左侧壁26连接在一起。
保持架2的顶部和底部是完全敞开的，因而没有顶壁和底壁。
在示出的椎间保持架中，四个侧壁相对于横穿脊柱的轴线的平面垂直地上升。
右侧壁25和左侧壁26具有细长开口27，细长开口27具有与横穿脊柱轴线的平面平行的轴线。在图1中，该开口的形状包括由径向裂口连接的三个圆柱形孔。
保持架2的内部具有由侧壁限定的空闲容积，用于由骨移植物填充。
保持架2的前侧壁22具圆柱形孔21，圆柱形孔21的内侧是经轧边的28。
垂直于保持架2的主平面安装的板1具有平的且大体为平行六面体的形状，而其端部为圆角。
板1与中空的圆柱形双头螺栓12一体地连接，双头螺栓12上具有狭长槽13和凸缘11，凸缘11的直径略大于保持架2的孔21的直径、但小于轧齿边28的直径。四个狭长槽13使得因此而形成的四个圆柱形部分具有一定的弹性，从而允许将中空的双头螺栓12引导至孔21内，并借助凸缘11与轧齿边28的配合将其锁定于孔中。
中空的双头螺栓12的内部具有螺纹14，螺纹14用于与下面描述的装置配合用于将板拆除。
板1通过穿过在板1的各端形成的孔14的螺钉(未示出)固定于相邻的椎骨上，如图1所示。这些孔被设置于板1上圆柱体12的每侧。
图2示出了连接在一起的板1和保持架2。板1上和保持架2可枢接在一起，从而允许固定螺钉安装在不同的位置。
图3示出了根据本发明的拆卸装置。该工具由轴杆4和管5组成。
管5的一端具有桥状物52，桥状物52具有两个支腿51；管5的另一端具有加宽的区域，例如允许将其抓握于手指之间。两个支腿51之间至少间隔板1的中间部分的宽度。
轴杆4的一端具有螺纹42，而另一端具有由轴杆4的加宽形成的手柄。
轴杆4延伸穿过管5，并在管5上远离螺纹桥状物52的端部6进入接合部(abutment)。
因此，支腿可在所述板的任一侧与保持架相对。轴杆4的螺纹端42可与中空的双头螺栓12的内螺纹接合。由于采用了螺纹连接，因而通过旋转手柄即可将板1抽出，而无需通过其他方式移动，尤其是平移。因此，螺纹连接使得轴杆4在管内纵向移动。
图4示出上述拆卸设备的剖视图，示出了轴杆4、管5和二者共同的接合部6。
图5中示出了用于拆卸板的装置，其支腿51在板1的各侧支撑于保持架2上。轴杆4的螺纹端42螺纹连接于安装在板1上的中空的双头螺栓12的带螺纹的内部。
图6示出了螺纹连接于板上的拆卸装置。通过简单的拖拉，双头螺栓12已被解锁，并且板1被抽出，而保持架2仍保持于适当位置。
图示出的保持架2由PEEK制成。板1由钛制成。

Claims (11)

1.用于对椎骨进行固定和体内融合的系统，包括至少一个保持架和一个与所述保持架的主平面垂直的板，所述系统的特征在于，所述板(1)和所述保持架(2)具有孔(21)和双头螺栓(12)，所述双头螺栓(12)能够插入所述孔(21)中并逆向地封锁于所述孔(21)内，从而允许所述板(1)能够相对于所述保持架(2)旋转，所述板(1)能够通过简单的拖拉操作而被移除。
2.根据权利要求1所述的系统，其特征在于，所述孔(21)形成于所述保持架内，而所述双头螺栓(12)安装于所述板(1)上。
3.根据权利要求1和2中之一所述的系统，其特征在于，所述双头螺栓(12)为圆柱形。
4.根据任意一项权利要求所述的系统，其特征在于，所述双头螺栓(12)为具有纵向裂口的中空圆柱体。
5.根据任意一项权利要求所述的系统，其特征在于，所述双头螺栓(12)具有位于所述板(1)内的、用于将所述双头螺栓(12)封锁于所述孔(21)内的系统。
6.根据权利要求1-5中任意一项所述的系统，其特征在于，所述双头螺栓(12)的一端具有升起的凸缘(11)。
7.根据任意一项权利要求所述的系统，其特征在于，所述双头螺栓(12)的内部具有用于固定拆卸装置的系统。
8.根据权利要求3-7中任意一项所述的系统，其特征在于，所述双头螺栓(12)的内部具有螺纹。
9.一种用于对椎骨进行固定和体内融合的系统的拆卸装置，其中所述系统包括至少一个保持架和一个与所述保持架的主平面垂直的板，其中，所述板(1)和所述保持架(2)具有孔(21)和双头螺栓(12)，所述双头螺栓(12)能够插入所述孔(21)并逆向地封锁于所述孔(21)中，从而允许所述板(1)能够相对于所述保持架(2)旋转，所述板(1)能够通过简单的拖拉操作而被移除，
其特征在于，所述拆卸装置包括配备有手柄的轴杆(4)，并且所述拆卸装置的端部具有用于将所述板(1)或所述双头螺栓(12)紧固的部件(42)，所述部件(42)安装于管(5)内，所述管(5)的一端具有两个相间隔的支腿(51)，用于放置在所述板(1)的任一侧，并用于支撑在所述保持架(2)上，所述轴杆(4)能够在所述管(5)内纵向移动。
10.根据权利要求9所述的拆卸装置，其特征在于，所述拆卸装置的所述轴杆(4)在其远离所述手柄的一端具有螺纹(42)。
11.一种成套工具，包括例如由权利要求1至8中任意一项所限定的用于对椎骨进行固定和体内融合的系统，以及例如由权利要求9至10中之一所限定的拆卸装置。
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CN104135971B (zh) * 2012-02-24 2016-12-21 Ldr医疗公司 用于椎间植入物的锚定装置和系统、椎间植入物以及植入仪器
CN102860888A (zh) * 2012-09-07 2013-01-09 中山大学附属第三医院 一体化腰椎椎间钛板融合器
CN102860888B (zh) * 2012-09-07 2015-08-05 中山大学附属第三医院 一体化腰椎椎间钛板融合器
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CN107095713A (zh) * 2016-02-22 2017-08-29 北京纳通科技集团有限公司 一种用于脊柱的固定系统
CN107095713B (zh) * 2016-02-22 2020-06-09 北京纳通科技集团有限公司 一种用于脊柱的固定系统
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BRPI0619437A2 (pt) 2011-10-04
WO2007065993A3 (fr) 2007-12-06
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CA2632848A1 (fr) 2007-06-14
MX2008007208A (es) 2008-10-17
EP1957011A2 (fr) 2008-08-20
EP1957011B1 (fr) 2017-09-20
CN101330884B (zh) 2011-02-16
FR2894130A1 (fr) 2007-06-08
KR20080085010A (ko) 2008-09-22
US20080294262A1 (en) 2008-11-27
JP2009518090A (ja) 2009-05-07
WO2007065993A2 (fr) 2007-06-14

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