CN100358484C - 用于融合椎骨的装置 - Google Patents

用于融合椎骨的装置 Download PDF

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Publication number
CN100358484C
CN100358484C CNB008034532A CN00803453A CN100358484C CN 100358484 C CN100358484 C CN 100358484C CN B008034532 A CNB008034532 A CN B008034532A CN 00803453 A CN00803453 A CN 00803453A CN 100358484 C CN100358484 C CN 100358484C
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China
Prior art keywords
implant
end member
face
bone
passage
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Expired - Fee Related
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CNB008034532A
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CN1352541A (zh
Inventor
多米尼克·D·梅瑟利
戴维·C·保罗
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AO Technology AG
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Synthes AG Chur
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Abstract

公开了用于融合椎骨的装置，包括植入体和用于该植入体的端部构件，其中端部构件包括：一具有纵向轴线(27)和顶面(18、812)的第一部分(12)，该顶面用于与椎骨的端板接触；一与纵向轴线(27)共轴的第二部分(14)，其形状与尺寸做成要装在植入体的端部上；一连接第一和第二部分(12、14)的肩部(16)，其尺寸做成在第二部分(14)装在植入体上时靠在植入体的边缘上，其特征为，顶面(18)有用于接纳外科手术器械的第一通道(20)；第二部分(14)的高度小于植入体的高度，以及，顶面(18、812)进一步包括多个用于与椎骨互锁的齿(32)。

Description

用于融合椎骨的装置
技术领域
本发明涉及用于骨头尤其是椎骨的融合的装置，并且特别涉及用于融合骨头尤其是椎骨的植入体的端部构件。
背景技术
骨缺陷的治疗和处理仍然是矫形学的具有挑战性方面之一。骨缺陷在非常广泛的临床状况下发生。要恢复具有骨缺陷的任何长形骨头的自然的解剖学上的长度和形状是有疑难的。此外，不论什么时候，当必须去掉椎骨时，必须插入一椎骨间距器，以恢复脊柱的自然长度和曲率，并且促进骨融合。恢复脊椎结构和稳定性，并且促进融合，在一种称为Corpectomy的外科手术过程中甚至还要困难，在该手术过程中，要去掉一段或几段椎骨。
研发了许多不同的植入体，以用在骨缺陷中。所谓的“筛网移植体”已经证明特别有效。这类植入体的一种是从美国赛州的Synthes(USA)of paoli公司得到的SynMeshTM。SynmeshTM是一个钛做的筛网圆柱体，它在其表面上做有许多均匀地隔开的、尺寸均匀的少孔，分布在其表面上。为了对付各种产生骨缺陷的临床状况，SynmeshTM可按不同长度和直径得到。市场上得到的用于治疗骨缺陷的同种植入体植入体现在已成为有用的。
虽然筛网式同种移植植入体的临床结果一般是肯定的，但是一种可能的临床并发症为植入体的沉陷(Subsidence)。只要骨头是极其多孔性的，植入体的端部的过度况入它所接触的骨头中是特别麻烦的。同时根据力学和生理学的观点，加大植入体与骨头之间的接触表面面积也是有益的。授予Biedermann等人的美国专利NO.5702451公开了企图对付这种情况的端环。不过，所公开的端环没有用于夹持、插入和拔出器械的设施。因此，移植可能很困难。
此外，在移植以后，在骨头与所公开的端环之间可能有过度的移动。这可能延缓甚至可能阻止骨融合。
从DE19509317ULRICH知道另一种用于骨头尤其是椎骨的融合的植入件，它由多个可沿轴向安装的构件组成。这种已知的植入体包括两个端部的植入体构件和一个中间的第三植入体构件，后者可绕一共同的轴线与端部构件作旋转的连接。中间构件用螺纹与一个端部构件连接，以使植入体的长度可通过转动中间构件来调节。
如同上面所讨论的所示出的那样，需要有一种与骨融合植入体一起使用的改进的端部构成件。
发明内容
本发明用一种用于骨头尤其是椎骨的融合的装置解决这一问题，并且特别涉及用于融合骨头特别是椎骨的植入体的端部构件。
按本发明的用于融合椎骨的装置，包括植入体和用于该植入体的端部构件，其中端部构件包括：一具有纵向轴线和顶面的第一部分，该顶面用于与椎骨的端板接触；一与纵向轴线共轴的第二部分，其形状与尺寸做成要装在所述植入体的端部上；一连接第一和第二部分的肩部，其尺寸做成在第二部分装在所述植入体上时靠在所述植入体的边缘上，其中，顶面有用于接纳外科手术器械的第一通道；第二部分的高度小于植入体的高度，以及顶面进一步包括多个用于与椎骨互锁的齿。
本发明涉及一种与和于融合部分骨头的骨融合植入体一起使用的端部构件。端部构件有一第一部分、一其尺寸做成能插入植入体的孔中的第二部分和一在第一部分与第二部分之间的肩部。当第二部分被插入孔中时，肩部靠在植入体的边缘上。第一部分的顶面在尺寸与形状上都与骨头一致并且有一个通道或多个通道，以用于接纳外科手术器械。当存在多个通道时，所有通道可按同一方向通过(例如，通道沿前外侧方向通过)，或通道可沿不同方向通过(例如，一第一通道沿前后方向通过，一第一通道沿横向通过)；以及顶面进一步包括多个用于与椎骨互锁的齿。
按本发明的一种优选实施方式，第一、二通道分别占第一部分的横截面面积的20％～50％、20％～80％。
如果植入体用金属制造，则端部构件也用同样的材料制造，以便耐腐蚀。端部构件也可以用同种植入体移植骨头制造，端部构件可以有楔形或球形轮廓，以恢复骨头的自然曲率或矫正非正交的切骨。建立楔形轮廓的一个途径为使第一部分的第一端比第二端厚。
顶面可做成任意的合适的截面形状，如卵圆形、椭圆形或圆形，并且可以是环形或实心的。顶面可以是扁平的平面，或可以有一模仿骨头的表面形貌的曲率。顶面可以做有齿，或将组织做成与骨头互锁。齿可以是角锥形或锯齿形。
为了将端部构件固定在植入体上，第二部分可以有一用于接纳紧固器的孔。另一种方案为，第二部分的外表面可以有突起，它们的尺寸做成能配合在植入体的小孔中。在一作为例子的实施例中，第二部分包括多个翼片，以将端部构件固定在植入体上。这些翼片可以有弹性，以使翼片在第二部分被插入植入体中时向内弯曲并向外往回弯曲，以建立一摩擦配合，将端部构件固定在植入体上。在另一实施中，端部构件有一铰接在或可摆动地连至第一部分上的突起、一在第二部分中的螺纹孔和一可插入螺纹孔中的紧定螺钉。将紧定螺钉拧入孔中，使突起向外移动，从而将端构件固定在植入体上。
在另一个实施例中，按照本发明的端部构件包括一其尺寸与形状都与骨头一致的顶面和一从顶面伸出的套筒，套筒的构形与尺寸做成能接纳植入体的一个端部。端部构件进一步包括第一和第二段，第二段可在一打开位置与一封闭位置之间摆动，在打开位置，有利于用套筒接纳植入体的端部，而在封闭位置则将端部构件固定在植入体上。一锁紧元件将端部构件紧固在封闭位置上。
在另一实施例中，端部构件包括一外环和一内环，外环有一具有做成斜坡的表面的尖头(prong)，内环可相对于外环旋转。内环有一突起，它在旋转时与尖头的做成斜坡的表面接触，从而将尖头沿径向向外推。
附图说明
在附图中公开了本发明的优选的特点，其中，相同的参考标号在几个附图中都代表同样的元件，其中：
图1示出按照本发明的端部构件的第一实施例的透视图；
图2示出插在圆柱形筛网植入体中的图1的端部构件的侧视图；
图3示出具有椭圆形的端部构件的透视图；
图4a示出一端部构件的透视图，它具有椭圆形状、并有用于改进植入体的稳定性的齿；
图4b示出一端部构件的透视图，它具有便于使用植入器械的第一和第二通道；
图4c示出端部构件的另一实施例的透视图，它具有第一和第二通道；
图5示出一端部构件的侧视图，它有一楔形轮廓；
图6示出一端部构件的透视图，它有用于固定在植入体上的突起；
图7示出一非环形端部构件的透视图；
图8示出按照本发明的端部构件的底部的透视图；
图9示出按照本发明的端部构件的底部的透视图；
图10示出按照本发明的端部构件的另一实施例的俯视图；
图11示出图10的端部构件的剖视图；
图12示出按照本发明的端部构件的另一实施例的俯视图；
图13示出固定在圆柱形筛网植入体上的图12的端部构件；以及
图14示出按照本发明的端部构件的另一实施例的剖视图。
具体实施方式
图1示出按照本发明的端部构件10的第一实施例。端部构件10有一第一部分12和一第二部分14。由于第一部分12大于第二部分14，故在第一和第二部分12、14之间的交界处形成一肩部16；第一部分12的顶面18上做有用于容纳外科手术器如夹持器械、插入器械和/或拔出器械的第一通道20。顶面18在图1中所示为有一圆形。不过，从其它实施例可以明白，顶面18可以有任何合适的形状。顶面18最好有一与其所接触的骨头的形状匹配的形状。
第二部分14也示出有一圆形。如同顶面18的情况一样，第二部分14可以有任何合适的形状。第二部分14的形状最好与和端部构件一起使用的骨融合植入体的形状匹配。如同在图2中最清楚地看出的那样，第二部分14的尺寸和形状做成能被插入骨融合植入体22的内孔中，以使肩部1 6靠在骨融合植入体22上。骨融合植入体22可以是多种不同类型的植入体，例如包括筛网植入体、同种植入体，或任何金属或非金属植入体。如果植入体22用金属材料制造，则端部构件10最好用同样的金属材料或用非金属材料制造，以避免混合的金属(电池)腐蚀。端部构件10也可用来自网眼状骨、皮质骨、网眼状骨与皮质骨的组合，或网眼状骨与皮质骨的复合物等制成的同种植入体骨做成。在端部构件10与骨融合植入体22植入以后，生理上的压力将会力图使端部构件10固定就位，靠在骨融合植入体22上。不过，为了提供进一步的稳定性，并便于手术前或手术中的搬运，第二部分14可以固定在骨融合植入体22上。例如，第二部分14可以压配合或弹夹配合在骨融合植入体22中。此外，由于骨融合植入体22通常是能变形的，故骨融合植入体22可以压折在端部构件10上。第二部分14也可做有一个孔24，以用于接纳像销或螺钉这样的紧固件。端部构件10被插入骨融合植入体22中，以使孔24与骨融合植入体22上的小孔26之一对齐。孔24可部分地或全部穿过第二部分14，并可做有螺纹。如图6所示，第二部分14可按另一种方案有突起28，其尺寸做成配合在小孔26中，以便机械地将端部构件固定在骨融合植入体上。将端部构件固定在骨融合植入体上的其它示例性机构在下面较详细地描述。
回过去看图1至2，顶面18的表面积大于骨融合植入体22的顶面与底面的表面积。由于有此较大的表面积，故在顶面18与所包围的骨头之间的接触面积将大于植入体22的顶面与底面的接触面积。接触面积的增加有助于抵抗植入体22的沉陷。加大的接触面积还有其它的好处，如在端部构件与所包围的骨头之间有较好的载荷分担。顶面18作为具有环形空间30的环示出。新的骨头可做成环形空间30的形状，以促进融合。环形空间中可填以骨屑或任何其它骨诱导的或骨传导(Osteoconductive)材料，以促进骨头的形成。
另一种方案为，如图7所示，顶面18可以是实心的表面，以使顶面18与所包围的骨头之间的接触面积为最大。实心的顶面18在这种临床状况中将是理想的，即，其中沉陷是特别关注的问题。
图3示出按照本发明的端部构件110的第二实施例。总体上，端部构件110(以及下面要描述的实施例)的大部分结构是与端部构件10的结构相同或可比的，因此，对于同样的部分采用了同样的参考数字，并且认为这些同样的部分的讨论是不必要的。端部构件110有一卵形或椭圆形的形状，并且用在所包围的骨头(因而是骨融合植入体)基本为卵圆形或椭圆形的情况。当端部构件有一种与端部构件110一样的非对称形状时，可沿任何取向设置第一通道20。例如，所示第一通道20是沿端部构件110的长轴通过的，不过，也可以按任何相对于所包围的骨头取向不同的方向通过。第一通道20的设置的易变性意味着，第一通道20可以放置成最适于所用的特殊的外科手术路径。具体地说，如果端部构件110通过沿前部/背部的方向的短轴植入，则第一通道20对于侧面的外科手术路径是理想的。如果希望是前面或背面的路径，则第一通道20应当沿前面-背面的方向延伸。
图4a示出一端部构件210，它具有相对于端部构件210的长轴按一角度通过的第一通道20。第一通道20的方向对于在脊椎外科手术中使用的前外侧外科手术路径是优选的。图4b示出一包括第一和第二通道20、21的端部构件212，它们都相对于端部构件212的长轴按一角度通过。第一和第二通道20、21最好相对于端部构件212的长轴对称地布置。在端部构件212上同时设置第一和第二通道20、21，使之在植入时，第一和第二通道20、21中的至少一个能够被接近，不管是用左侧还是右侧作为前外侧(anterolateral)外科手术路径。此外，通道20、21的布置允许在骨融合植入体的每一端上使用一个端部构件，并且在顶部的端部构件上仍然有通道与底部的端部构件的通道对齐。图4c示出一端部构件214，它也包括第一和第二通道20、21。第一通道20平行于端部构件214的长轴通过，而第二通道2 1则垂直于端部构件214的长轴通过。在端部构件214上同时包括第一和第二通道20、21，提供对第一和第二通道20、21的至少一个的接近，而不管端部构件214的植入取向和外科手术路径如何。
对图4a、4b和4c所示的每个端部构件，顶面18有多个齿32，它在端部构件和所包围的骨头之间提供一机械的互锁。齿32通过刺入骨头提供机械的互锁。由齿32提供的初始的机械稳定性使端部构件的手术后的拉出或挤出的危险性成为最小。齿32可有任何合适的构形如角锥形、锯齿形等等。要不然，顶面18也可以将结构做成在端部构件与所包围的骨头之间提供机械的互锁。
如图5所示，端部构件310有一楔形轮廓。楔形轮廓可用在脊椎应用中，以便恢复脊椎骨或其它骨头的自然曲率。楔形轮廓也可用于补偿病理学所从事的、临床状况下或去掉骨头时错误地造成的非垂直切骨。应当指出，由于端部构件通常都用在骨融植入体的每一端，故可以同时使用具有不同楔形轮廓的端部构件。达到这种楔形的一种方式来自在第一部分12上从第一端34至第二端36逐渐减小厚度，以使顶面有由一角度α规定的斜度。在图5中，所示顶面18为一平直的平面。不过，顶面18也可以是曲线形的表面，但是仍然保持楔形的轮廓。由于曲线可以做成脊椎骨端板的表面形貌的镜面映像，故曲线形的顶面18可以与脊椎骨端板的轮廓形状一致。
如同前面所讨论的那样，图6示出一做有突起28的端部构件，该突起的尺寸做成能配合在骨融合植入体22(图2)的小孔26中。也已经讨论过的图7示出一具有实心的顶面18的端部构件510，该顶面最好在有较高的沉陷发生率时使用。
图8示出一有一第二部分14的端部构件610，该第二部分包括多个翼片40，用于将端部构件610固定在骨融合植入体22上。在一个实施例中，翼片40有弹性，以致当端部构件610的第二部分14被推入骨融合植入体中时，翼片40向内弯曲，然后往回向外弯曲，以将端部构件610固定在骨融合植入体22上。由于骨融合植入体22有一些弹性，使之能向外弯曲，以接纳翼片40，故翼片40不一定必须是有弹性的。翼片40的数目、尺寸和布置可以改变。图9示出与端部构件610相似的端部构件710，它只是整体形状有所改变(从圆形变成卵圆形或椭圆形)。
图10和11示出一端部构件810，它有另一种将端部构件810固定在骨融合植入体22上的机构。具体一些说，端部构件810是一个盖子，它座落在植入体22的顶上。端部构件810包括一顶面812与一套筒814，顶面的尺寸与形状与骨头一致，套筒从顶面812伸出。套筒814的形状与尺寸做成接纳植入体22的一部分。为了便于在植入件22中插入端部构件810和从其中取出，端部构件810最好做成两段816、818。在一个作为例子的实施例中，段816、818在枢轴820处可摆动地连接，以使段816、818可以分开，也就是说，端部构件810打开。端部构件810还包括一锁紧机构，以使两段816、818保持接触。在一个实施例中，此锁紧机构包括一第一有细齿的边缘822，它与第二有细齿的边缘824合作。
图12和13示出一端部构件910，它包括内环和外环912、914。内环912可相对于外环914旋转。内环912有用于接纳工具以转动内环912的措施(所示为孔916，它接纳工具的尖头)。内环912还有一对突起918，它与位于外环914上的有弹性的尖头920合作。当内环912旋转时，突起918与尖头920接触并沿径向往外推尖头920。当端部构件910配合在植入体22中时，尖头920的沿径向向外的移动使尖头920压靠在植入体22上，以将端部构件910固定在植入体22上。
图14示出一端部构件950，其中，第二部分14包括至少一个突起952。突起952在接合处953可摆动地与第二部分14连接，以便当一紧定螺钉954拧入螺纹孔956时，紧定螺钉954使突起952向外移动。此向外移动将端部构件950固定在植入体22上。接合处953最好有一比突起952的其余部分小的横截面，以使由紧定螺钉954产生的弯曲在接合处953产生。
虽然在上面描述了本发明的各种说明，但是应当明白，各种特点可以单独使用或按其任何组合使用。
因此，本发明不仅仅限于此处所引用的专门优选的实施例。此外，应当明白，对于熟悉本发明所属的技术的人，可以在本发明的范围内作各种改变与改进。因此，根据此处所提出的、在本发明的范围与精神内的公开内容，由本领域的技术人员得到的所有合适的改进都可作为本发明的其它实施例包括在内。因此，本发明的范围由所附权利要求所限定。

Claims (34)

1.一种用于融合椎骨的装置，包括植入体和用于该植入体的端部构件，其中端部构件包括：
A)一具有纵向轴线(27)和顶面(18、812)的第一部分(12)，该顶面用于与椎骨的端板接触；
B)一与纵向轴线(27)共轴的第二部分(14)，其形状与尺寸做成要装在所述植入体的端部上；
C)一连接第一和第二部分(12、14)的肩部(16)，其尺寸做成在第二部分(14)装在所述植入体上时靠在所述植入体的边缘上，其特征为，
D)顶面(18)有用于接纳外科手术器械的第一通道(20)；
E)第二部分(14)的高度小于植入体的高度，以及
F)顶面(18、812)进一步包括多个用于与椎骨互锁的齿(32)。
2 .如权利要求1的装置，其特征为，第二部分(14)的形状与尺寸做成能被插入植入体的一个孔中。
3.如权利要求1的装置，其特征为，第二部分(14)包括一套筒(814)，其形状与尺寸做成能接纳植入体的一个端部。
4.如权利要求1至3的任一项的装置，其特征为，顶面(18、812)有用于接纳外科手术器械的第二通道(21)。
5.如权利要求1至3的任一项的装置，其特征为，通道(20)穿入第一部分(12)中，与纵向轴线(27)正交。
6.如权利要求4的装置，其特征为，第二通道(21)穿入第一部分(12)中，与纵向轴线(27)正交。
7.如权利要求1至3的任一项的装置，其特征为，第一通道(20)朝顶面(18、812)敞开。
8.如权利要求4的装置，其特征为，第二通道(21)朝顶面(18、812)敞开。
9.如权利要求1至3的任一项的装置，其特征为，第一通道(20)的形状做成相对于纵向轴线(27)对称。
10.如权利要求4的装置，其特征为，第二通道(21)的形状做成相对于纵向轴线(27)对称。
11.如权利要求1至3的任一项的装置，其特征为，第一通道(20)占第一部分(12)的横截面面积的20％～80％。
12.如权利要求4的装置，其特征为，第二通道(21)占第一部分(12)的横截面面积的20％～50％。
13.如权利要求4的装置。其特征为，第一通道(20)相对于第二通道(21)按一角度通过。
14.如权利要求4的装置，其特征为，第一通道(20)平行于第二通道(21)通过。
15.如权利要求1至3的任一项的装置，其特征为，齿(32)有角锥形形状。
16.如权利要求1至3的任一项的装置，其特征为，顶面(18、812)是实心的。
17.如权利要求1至3的任一项的装置，其特征为，顶面(18、812)是环形的。
18.如权利要求1至3的任一项的装置，其特征为，顶面(18、812)是圆形的。
19.如权利要求1至3的任一项的装置，其特征为，顶面(18、812)是卵形或椭圆形的。
20.如权利要求1至3的任一项的装置，其特征为，顶面(18、812)是扁平的平面。
21.如权利要求1至3的任一项的装置，其特征为，端部构件有一楔形轮廓。
22.如权利要求21的装置，其特征为，第一部分(12)有一第一端(34)和一第二端(36)，第一端的高度大于第二端的高度，以产生楔形轮廓。
23.如权利要求1至3的任一项的装置，其特征为，端部构件可紧固在植入体上。
24.如权利要求23的装置，其特征为，端部构件可松开地与植入体连接。
25.如权利要求24的装置，其特征为，第二部分(14)有一用于接纳一紧固件的孔(24)，以将端部构件固定在植入体上。
26.如权利要求1或2的装置，其特征为，第二部分(14)的外表面有至少一个突起(28)，其尺寸做成配合在植入体的一个小孔中，以将端部构件固定在植入体上。
27.如权利要求1或2的装置，其特征为，第二部分(14)包括多个翼片(40)，以将端部构件固定在植入体上。
28.如权利要求27的装置，其特征为，所述多个翼片(40)的每一个都有弹性，在第二部分(14)插入植入体中时向内弯曲并朝外往回弯曲，以将端部构件固定在植入体上。
29.如权利要求1至3的任一项的装置，其特征为，端部构件用与植入体相同的材料制造。
30.如权利要求1至3的任一项的装置，其特征为，端部构件用同种植入体骨头制造。
31.如权利要求1或2的装置，其特征为，所述端部构件进一步包括一与第一部分(12)可摆动地连接的突起(952)、一在第二部分(14)中的螺纹孔(956)和一紧定螺钉(954)，该螺钉可用螺纹插在螺纹孔中，紧定螺钉(954)插在螺纹孔(956)中，使突起(952)往外移动，将端部构件固定在植入体上。
32.如权利要求3的装置，其特征为，第一和第二部分(12、14)各自包括两段(816、818)和一锁紧机构，该两段可在一打开位置与一封闭位置之间摆动，在打开位置，便于用套筒(814)接纳植入体的端部，在封闭位置，将端部构件固定在植入体上，锁紧机构将端部构件固定在封闭位置上。
33.如权利要求32的装置，其特征为，锁紧机构包括一第一有细齿的边缘(822)和一第二有细齿的边缘(824)，这些边缘彼此合作。
34.如权利要求1至3的任一项的装置，其特征为，第二部分(14、910)包括一外环(914)和一内环(912)，外环有一具有做成斜坡的表面的尖头(920)，内环可相对于外环(914)旋转并包括至少一个突起(918)，该突起(918)在旋转时与尖头(920)的做成斜坡的表面接触，从而沿径向向外推尖头(920)。
CNB008034532A 1999-02-04 2000-02-03 用于融合椎骨的装置 Expired - Fee Related CN100358484C (zh)

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WO2000045751A1 (en) 2000-08-10
TW519488B (en) 2003-02-01
KR20020016612A (ko) 2002-03-04
AU758029B2 (en) 2003-03-13
CA2360871A1 (en) 2000-08-10
CN1352541A (zh) 2002-06-05
EP1148848A1 (en) 2001-10-31
ES2329332T3 (es) 2009-11-25
KR100757066B1 (ko) 2007-09-10
DE60042817D1 (en) 2009-10-08
EP1148848B1 (en) 2009-08-26
NZ513158A (en) 2003-10-31
CA2360871C (en) 2009-04-28
ATE440572T1 (de) 2009-09-15
AU2274500A (en) 2000-08-25
JP2002536063A (ja) 2002-10-29
ZA200105336B (en) 2002-01-17

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