CN105025845A - 可侧向扩张的椎间融合植入物 - Google Patents

可侧向扩张的椎间融合植入物 Download PDF

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Publication number
CN105025845A
CN105025845A CN201380065299.2A CN201380065299A CN105025845A CN 105025845 A CN105025845 A CN 105025845A CN 201380065299 A CN201380065299 A CN 201380065299A CN 105025845 A CN105025845 A CN 105025845A
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CN
China
Prior art keywords
intervertebral fusion
fusion implant
supportive body
side stand
implant
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Granted
Application number
CN201380065299.2A
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English (en)
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CN105025845B (zh
Inventor
K.德姆舍夫斯基
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Facet Link Inc
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Facet Link Inc
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Priority claimed from EP12197580.9A external-priority patent/EP2742915A1/de
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Publication of CN105025845A publication Critical patent/CN105025845A/zh
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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Abstract

本发明涉及一种用于使两个相邻的椎骨融合的椎间融合植入物;该椎间融合植入物包括可调节的支撑构件(2),该支撑构件的下表面和上表面(23、34)被设计成支撑在相邻椎骨的端面上。可以侧向地围绕连接点(30)而旋转的侧臂(3)具有平面的顶部(34)和平面的顶部(33)。设置驱动装置(4),该驱动装置是用于使侧臂(3)旋转进入其中使侧臂从支撑构件(2)中展开的位置(图2b;操作位置)。因此,植入物是特别地小,并且在被植入目标位置之后可以启动使得植入物扩张,从而在椎间隙中提供较大的支撑面。因此,可以利用微创手术来治愈甚至相对较大面积的缺陷。

Description

可侧向扩张的椎间融合植入物
技术领域
本发明涉及一种用于使两个相邻椎骨融合的椎间融合植入物;该椎间融合植入物包括可调节的支撑主体;该支撑主体的基部表面和盖板表面构造成支承在椎骨上。
脊柱的椎间盘由于磨损或病理变化而遭受退变。如果采用药物和/或理疗的保守治疗无效,那么有时需要进行手术治疗。就此而论,已知将可移动或不可移动的植入物插入容纳退化椎间盘的椎间隙中。该植入物接替退化椎间盘的支撑功能,并且在这个意义上讲恢复相邻椎骨之间的稳定支撑。不可移动的植入物也被称为“融合植入物”。
已知有各种外科技术可用于将融合植入物植入。传统的外科技术牵涉到腹侧进入路径,由此避免损伤脊柱中脊髓的危险。然而,该优点的获得是以经过患者腹腔或胸腔的非常长的进入路径为代价。因为这会引起并发症,所以已确立了替代的进入路径,即从背侧进入。尽管后者提供短路径的优点,但存在碰撞或损伤脊髓的危险。为了使此危险最小化,通常是通过微创手术来执行操作。直接从背侧进入的此类型方法被称为PLIF(后路腰椎椎体间融合术)或TLIF(经椎间孔腰椎椎体间融合术),其中分别从后向方向或侧向方向使椎间盘暴露。由于此方法中采用的通过微创手术所形成的横向切口较小,因而融合植入物的尺寸势必受到很大的限制。
对于采用PLIF或TLIF技术的治疗而言,已知有非常小的融合植入物。这些植入物提供以下优点:由于它们具有小尺寸,因而能够通过微创手术而植入。然而,它们的小尺寸的固有缺点是:由于小尺寸,因而支撑功能是有限的,有时是不充分的。尽管较大尺寸的融合植入物将会改善支撑功能,但由于微创手术的限制因而是不现实的。
已完成本发明以改进在本文开始部分所提及类型的融合植入物,该融合植入物虽然仍然具有小的进入截面(如微创手术中所常见的),但它可以实现改善的支撑效果。
根据本发明,提供一种用于使两个相邻椎骨融合的椎间融合植入物;该植入物包括可调节的支撑主体,该支撑主体的基部表面和盖板表面构造成支承在相邻椎骨的端板上,就侧支架而言,该侧支架可以围绕铰链侧向地枢转并且其基部和盖板具有平面的延伸部;本发明还提供一种驱动装置,该驱动装置是用于使侧支架枢转出而进入从支撑主体中展开的位置(工作位置)。
本发明是基于开发椎间融合植入物的概念;该植入物在组装位置具有特别小的尺寸,并且在组装后可以在设想的植入部位被启用使得它变得较大并由此在椎间隙中提供较大的用于支撑的支撑表面。后一种状态被称为工作位置。结果,根据本发明的植入物将经过相对较小的进入开口而进入的优点(正如微创手术中所常见的)与具有相对较大支撑表面的优点(正如以显著地更加创伤性的方式而植入的常规植入物中所常见的)统一起来。
本发明是基于以下概念:由于侧向枢转机构而使植入物尽可能小以便于组装、以及通过枢转出而使植入物在设想的植入部位尽可能大。这里,首先将看似矛盾的目的,即用于植入的小尺寸与用于使椎骨相互融合的最大可能支撑表面相互联系起来。因此,根据本发明的植入物也适合于治疗相对较大面积的椎间盘缺陷,该植入物应当是精确的,即使仅通过微创手术便可执行操作。在现有技术中没有该植入物的实例。
侧支架有利地构造成铰杆扩张器,该铰杆扩张器包括具有展开臂的枢转臂。因此形成大致三角形的结构,该结构能够良好且安全地引导枢转出的臂,由此有效地消除在枢转期间卡住(这会导致植入物的闭锁)的危险。如果在工作位置展开臂被锁紧在支撑主体上,这是特别有利的。这种锁紧确保工作位置的维持,即使在出现大的负载的情况下。在一个经证实的实施例中,在展开期间将滑动部件附接到展开臂,并且利用驱动装置使滑动部件发生位移特别是回缩,并且当到达工作位置时优选地锁定入凹槽中。该锁定导致强制锁紧,从而提供针对不希望的分离的特别高的安全性。
为了确保根据本发明的植入物在组装期间具有尽可能小的尺寸,优选地将侧支架回缩入支撑主体中。通过这种定位而获得最小可能设计。因此,可以选择支撑主体的最大可能尺寸;因此,也可以将回缩到支撑主体中的侧支架选择成相对较大。
为了简化插入并且消除被束缚在周围组织上的危险,侧支架的基部和盖板优选地构造成使得它们与处在组装位置中的支撑主体的基部和/或盖板表面齐平。这形成无间隙的连续表面。如果侧支架的基部和盖板位于平面中,即它们与支撑主体的基部和/或盖板表面对齐,则尤其可证明了其价值。所实现的是,在展开后支架的基部和盖板可与两个相邻椎骨的端板可靠地接触,该接触与支撑主体自身同样是精确的。
为了促进根据本发明的植入物生长入椎间隙中,可以设置被布置在支撑主体的基部表面和/或盖板表面上并且/或者被布置在侧支架的基部或盖板上的切削齿。切削齿,尤其在展开运动期间,可以导致端板的修整,由此促进并加速自然骨生长因此促进并加速两个椎骨的受欢迎的融合。
在侧支架的自由端有利地设置扩张构件,该扩张构件分别对于基部和盖板是精确的。该扩张构件增大在侧支架的自由端区域中的负荷承载表面。由此,进一步改善支撑效果。
已证明将侧支架的长度设计成短于支撑主体的长度是有利的。该长度的优选值是在支撑主体长度的0.7至0.9倍的范围。如果侧支架的铰链被定位成在展开状态中使得支撑主体与侧支架形成近似等腰三角形,则形成对于实际要求是非常有利的用于展开状态的几何形状。这可以实现端板的牢固支撑,尤其是在其靠近边缘的区域,该区域具备相对较硬的皮质层。然后,支撑效果显著地优于常规植入物的情况,常规植入物由于它们的小尺寸性质因而是位于其中承载能力显著较小的端板的中心。
侧支架优选地构造成使得侧支架枢转出至少达支撑主体宽度值的三倍的行程。由此实现能够实现牢固支撑的植入物的基部宽度,甚至在椎间隙中只有单个植入物的情况下。
对于实际应用而言,如果支撑主体的端面(优选地前端面)具有斜面并且是大体平直的,则是有利的。这里,前端面应理解成是在植入状态中朝向患者前侧的端面;因此,后侧是朝向患者背侧的一侧。借助于平坦化的端面,而减小对与椎体邻接的组织(特别是延伸到椎体的大血管)造成组织刺激的危险。由此,显著地减小由于植入所造成损伤的危险。
为了能够可靠地驱动椎间融合植入物使其经过也为植入物植入所设置的相同进入路径,优选地设置用于驱动装置的端面连接件,优选地在后端面上。结果,可以驱动椎间融合植入物经过相同的进入路径,并且这不需要改变进入路径或者甚至布设另一个进入路径。
驱动装置有利地具有自我保持设计。由此使得在没有额外支撑的情况下将支架固定在枢转出的位置。在用于驱动装置的一个有利实施例中,设置作为驱动器的主轴。这使精确地运动到目标位置成为可能,因为主轴的每次旋转运动实现特定量的由间距所预先确定的展开。此外,主轴能够实现可逆的驱动,因此如果在植入期间出现意外问题,展开臂也可以任选地再次枢转回。主轴所提供另一个优点是固有的自我保持。
如果在展开后自我保持性能不是决定性的,因为例如支架在任何情况下通过锁紧而牢固地保持在其展开位置,那么可以设置可取出的主轴。结果,在植入完成后能够取出主轴。一方面,这提供身体异物不必停留在体内的优点,另一方面,这提供能够将骨材料(例如移植物或碎屑)导入如此形成的支撑主体的空腔中的优点。因此,所导入的骨材料促进骨生长并由此加速相邻椎体的融合。优选地设置开口,在驱动装置的情况下经过该开口而完全地进入支撑主体的空腔。该开口经常将是经过其中将驱动装置导入支撑主体中的开口。
此外,本发明涉及一种用于椎间融合植入物的器械包;该器械包包括导向管、插入杆和驱动杆。将插入杆插入导向管并将插入杆连接到在导向管后端面上的椎间融合植入物。为了可旋转地将植入物牢固地保持在导向管上,导向管优选地具有舌部,该舌部被设计成接合入在椎间植入物的支撑主体的相应凹槽中。最后,用插入杆推动驱动杆使其经过导向管。驱动杆的作用是驱动驱动装置。驱动杆优选地自身承载一部分的驱动装置,即在其前端采用螺纹的形式,其中该螺纹起用于驱动装置的主轴的作用。
附图说明
下面将参照其中描绘优选示例性实施例的附图来更详细地说明本发明。具体地:
图1示出了根据本发明的、在椎体之间的椎间隙中的椎间融合植入物的示意图。
图2示出了处在组装位置和工作位置中的、根据图1的示例性实施例的图示。
图3示出了第一示例性实施例的透视图。
图4示出了器械包的图示。
图5示出了关于插入器械的连接的详细图示。
图6示出了第二示例性实施例的主视图。
图7示出了第二示例性实施例的透视图。
图8示出了处在工作位置中的、在组装期间和组装完成后的中间状态的第二示例性实施例的图示。
图9示出了处在组装位置和工作位置中的第三示例性实施例的图示。
具体实施方式
提供一种用于植入在两个紧邻的椎体9、9’之间的椎间隙91中的椎间融合植入物,该椎间融合植入物在全文中是用附图标记1表示。在生理学完好的脊柱中,椎间盘90位于在椎骨之间的椎间隙中。该椎间盘由于疾病或磨损会经历退变,因此必须至少部分地将其切除。为了实现椎间隙91的充分支撑,尽管有椎间盘材料的损失,并且为了防止脊柱的塌陷,而将椎间融合植入物1插入椎间隙91中。椎间融合植入物1提供支撑行为,因此以自然的方式通过骨生长而促进两个相邻椎骨9、9’的融合。
现在参照图2和图3中的图示。图中所描绘的第一示例性实施例包括支撑主体 2,并且侧支架3以可借助于铰链30而枢转的方式被布置在支撑主体 2上 。侧支架具有两部分设计,其中枢转臂31的一端以枢转方式可移动地被安装在铰链30上并且同样地以可通过第二铰链36而枢转的方式可移动地连接到展开臂32。这形成可以枢转出的结构,如同铰杆(参照图2b)。
还提供驱动装置4,在图示的示例性实施例中该驱动装置4包括整体的驱动主轴41和滑动部件 42。用固定销43将滑动部件42以枢转方式可移动地布置在展开臂32的自由端上。在中心,滑动部件 42具有带阴螺纹的通孔。将驱动装置的主轴41引导经过该通孔,并且利用主轴41的头部44将驱动装置的主轴41安装在支撑主体2的后端壁22中。如果通过主轴头的旋转使主轴41旋转,那么滑动部件42从在主轴前端的组装位置(参见图2a)开始在向后方向上运动,其中枢转臂31和展开臂32侧向地枢转出,如同膝关节。
在其前部的放大前端面21上,支撑主体2具有平直的斜面。相对于由主轴41所形成的支撑主体2的纵向轴线的法线,该斜面具有大约20°的角度。利用斜面可实现前端面的平直的、非突出设计。由此,使对位于椎骨前面的组织造成刺激的危险最小化。
支撑主体2具有在其上侧上的盖板表面23、和相应地在其下侧上的基部表面24。盖板表面23和基部表面24是用于支承在两个相邻椎体9、9’的相应端板92、93上。与盖板表面23和基部表面24齐平的是侧支架3的盖板 33或基部34。所实现的是:在与来自支撑主体2的支撑相同的水平面上,在枢转出的侧支架上存在支撑。在组装位置中,盖板33与支撑主体的盖板表面23齐平;因此同样地基部34相对于基部表面24齐平。
齿5被布置在盖板33和基部34上(这里未示出)。齿被对准使得当侧支架3枢转出时,齿从相关的端板92、93中除去骨材料并因此执行在此区域中的骨修整。
为了植入的目的,而提供图4中所描绘的器械包7。该器械包7包括插入杆70、导向管73和驱动杆76。推动插入杆70使其经过导向管73,并将插入杆70的前端附接到椎间融合植入物1的支撑主体2。可以经过例如在PLIF(后腰椎间融合)法范围内所形成的微创进入路径,将如此形成的组合体导入椎间隙91中。然后它占据图2a中所示的位置。在下一步骤中,利用驱动装置而展开。在根据图2和图3中所描绘的示例性实施例中,为此目的,将合适的螺杆驱动器插入驱动主轴41的螺纹头44中,由此通过使主轴41旋转而使侧支架3枢转出。这是以如下方式而实现:借助于正在被旋转的主轴41在向后方向上(即朝向螺纹头44)拉动的滑动部件42因此借助于附接到滑动部件 42的展开臂32,而使侧臂31枢转出。最后,到达图2b中所示的组装位置。
在图2b中,能够确认:具体地由虚线所表示的椎体的硬皮质边缘以有利于力传递的方式而承载于在盖板表面或基部表面上的宽表面部上(即在支撑主体2的后端面和前端面的区域)以及承载于被设置在侧支架3上的扩张构件39上。由于该宽的设计,可以实现非常好的力传递,甚至对于相对较小的植入物。
图9中所描述的第三示例性实施例是第一示例性实施例的变体。显著的不同之处在于:利用铰链30’将侧支架3联接在后端上,而不是联接在前端上,如图1至图3中所描绘的第一实施例。因此,根据第三示例性实施例的椎间融合植入物在相反的方向上展开,即在向前方向上。结果,用于驱动主轴41的螺纹头44’位于与铰链30’相同的一侧,铰链30’相应地具有侧向偏移由此在这里提供充分的安装空间。此外,在此实施例中,后端面23’也具有斜面从而获得尽可能地平滑且不具有刺激周围组织危险的末端。否则,相同的部件具有与上述第一示例性实施例相同的功能。它们也具有相同的附图标记。关于此方面,可参考以上的描述。
参照图5-图8来说明第二示例性实施例。第二示例性实施例大体上具有与第一示例性实施例相同的设计,其中相同或相似的元件是用相同的附图标记来表示。其不同之处在于驱动装置4’。因此,在驱动装置4’中设置滑动部件42,利用该滑动部件42以与第一示例性实施例同样的方式实现侧支架3的展开。然而,驱动装置4’不包括其自己的主轴,但仅仅将相应的主轴安装于在支撑主体后端面22上的扩大的开口25中。该扩大的开口25可以具有阴螺纹。开口25的直径是引导经过铰链部件的带螺纹通孔的尺寸的大约两倍。
此外,从端面22中延伸出的U形凹槽27被设置在支撑主体2的基部侧24上。U形凹槽27是用于保持器械包的固定舌部,正如将在下面所说明的。
此外,凹槽28被布置于在其中滑动部件42位于工作位置中的支撑主体区域中的盖板表面和基部表面23、24上。这些凹槽的形状被设计成使得它们以强制锁紧方式来保持展开臂32的滑动部件侧端。以此方式,将展开臂锁紧在向前/向后方向上,因此也将枢转臂31锁紧在其枢转出的位置。为了确保牢固的强制锁紧,展开臂32的铰链部件侧具备接合边缘38。因此,凹槽28与接合边缘38共同地构成锁紧装置8。
由于独立于驱动装置4的锁紧装置8,因而在使侧支架3枢转出之后主轴41不再必须停留在植入物中。因此,可以取出所述主轴。结果,为保持主轴头44而设置的开口25变得不被占据,并且可以用作用于支撑主体2中的内部空间20的进入开口。结果,在将植入物插入并将其展开进入工作位置之后,可以经过微创开口将移植物或碎屑与骨材料一起导入,从而促进两个邻接椎体9、9’的融合。
在下文中描述了使用器械包的植入,如图4中所示。导向管73具有在其前端的舌部74;该舌部74以强制锁紧的方式接合在支撑主体2中的凹槽27中,因此将主体2加以固定以对抗导向管73上的旋转。推动插入杆70使其经过导向管73,并且将在前端的其螺纹71拧入开口25中的阴螺纹。结果,将在导向管73处的植入物牢固地保持在插入杆70上(参见图5)。在下一步骤中,引导驱动杆76经过插入杆70,为此目的已将插入杆70钻成空心的。利用其螺纹77,使驱动杆76接合入滑动部件42中。结果,在其组装位置中,将植入物1’保持在器械包上,如图6中所示。然后,可以经过微创进入路径,将植入物1’导入椎间隙91中。此后,通过使驱动杆76旋转而使滑动部件42在向后方向上运动,驱动杆76起驱动装置4的主轴的作用,因此使展开臂32向外运动并且相应地使枢转臂31在侧向方向上枢转出。当锁紧装置8的锁止件38接合在凹槽28中时,利用完全枢转出的枢转臂31而达到组装位置。结果,将植入物锁紧。然后,可以取出驱动杆76,并且同样地可以用插入销70将导向管73取出。

Claims (24)

1.一种用于使两个相邻椎骨(9、9’)融合的椎间融合植入物,所述椎间融合植入物包括可调节的支撑主体(2),所述支撑主体(2)的基部表面和盖板表面(23、24)构造成支承在所述相邻椎骨(9、9’)的端板(92、93)上;
其特征在于,设置侧支架(3),所述侧支架(3)可以围绕铰链(30)侧向地枢转,并且所述侧支架(3)的基部(34)和盖板(33)具有平面的设计,并且设置驱动装置(4),所述驱动装置(4)是用于使所述侧支架(3)枢转出去而进入从所述支撑主体(2)中展开的位置(工作位置)。
2.如权利要求1所述的椎间融合植入物,其特征在于,所述侧支架(3)构造成为具有枢转臂(31)和展开臂(32)的铰杆扩张器。
3.如权利要求2所述的椎间融合植入物,其特征在于,在所述工作位置将所述展开臂(32)锁紧在所述支撑主体(2)上。
4.如权利要求3所述的椎间融合植入物,其特征在于,在所述展开期间将滑动部件(42)附接到所述展开臂(32)并且利用所述驱动装置(4)使所述滑动部件(42)位移,并且当到达所述工作位置时优选地将其锁定入凹槽(28)中。
5.如前述权利要求中任一项所述的椎间融合植入物,其特征在于,在组装位置中,将所述侧支架(3)回缩入所述支撑主体(2)中。
6.如权利要求5所述的椎间融合植入物,其特征在于,在所述组装位置中,所述侧支架(3)的所述基部(34)和/或盖板(33)与所述支撑主体(2)的所述基部和/或盖板表面(23、24)齐平。
7.如前述权利要求中任一项所述的椎间融合植入物,其特征在于,使所述侧支架(3)的所述基部(34)和/或盖板(33)与所述支撑主体(2)的所述基部和/或盖板表面(23、24)对齐。
8.如权利要求7所述的椎间融合植入物,其特征在于,将切削齿(5)布置在所述基部(34)和/或盖板(33)上。
9.如前述权利要求中任一项所述的椎间融合植入物,其特征在于,将所述基部(34)和/或盖板(33)的扩张构件(39)设置在所述侧支架(3)的所述自由端。
10.如前述权利要求中任一项所述的椎间融合植入物,其特征在于,所述侧支架(3)具有所述支撑主体(2)的长度的大约0.7至0.9倍的长度。
11.如权利要求10所述的椎间融合植入物,其特征在于,用于所述侧支架(3)的所述铰链(30)被定位成使得所述支撑主体(2)与所述展开的侧支架(3)形成近似等腰三角形。
12.如前述权利要求中任一项所述的椎间融合植入物,其特征在于,所述侧支架(3)枢转出去至少达对应于所述支撑主体(2)的宽度值的三倍的行程。
13.如前述权利要求中任一项所述的椎间融合植入物,其特征在于,所述支撑主体(2)的端面(21)优选地前端面具有斜面并且大体上是平直的。
14.如前述权利要求中任一项所述的椎间融合植入物,其特征在于,在端面(22)上优选地在后端面上,设置用于所述驱动装置(4)的连接件(44)。
15.如前述权利要求中任一项所述的椎间融合植入物,其特征在于,所述驱动装置(4)是自我保持的。
16.如前述权利要求中任一项所述的椎间融合植入物,其特征在于,所述驱动装置(4)具有作为驱动器的主轴(41)。
17.如权利要求16所述的椎间融合植入物,其特征在于,所述主轴(41)是可取出的。
18.如前述权利要求中任一项所述的椎间融合植入物,其特征在于,设置开口(25),当经过所述开口(25)取出所述驱动装置(4)时可完全地进入在所述支撑主体(2)中的空腔(20)。
19.如前述权利要求中任一项所述的椎间融合植入物,其特征在于,将用于插入杆(70)的附接件布置在所述支撑主体(2)上,所述附接件优选地采用具有阴螺纹的开口(25)的形式。
20.如前述权利要求中任一项所述的椎间融合植入物,其特征在于,将用于扭转支撑的联接件(27)布置在所述支撑主体(2)上。
21.如前述权利要求中任一项所述的椎间融合植入物,其特征在于,在所述支撑主体(2)上设置用于所述侧支架(3)的锁紧装置(8)。
22.一种用于如权利要求1至21中任一项所述的椎间融合植入物的器械包,其特征在于,所述器械包(7)包括导向管(73)、插入杆(70)和驱动杆(76)。
23.如权利要求22所述的器械包,其特征在于,将用于接合入所述椎间融合植入物的所述支撑主体(2)中的舌部(74)布置在所述导向管(73)的前端。
24.如权利要求22或23所述的器械包,其特征在于,所述驱动杆(76)具有在其前端的螺纹(77),所述驱动杆(76)起所述驱动装置(4)的主轴的作用。
CN201380065299.2A 2012-12-14 2013-12-16 可侧向扩张的椎间融合植入物 Expired - Fee Related CN105025845B (zh)

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