CN101111207B - 椎间盘假体 - Google Patents

椎间盘假体 Download PDF

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Publication number
CN101111207B
CN101111207B CN2005800476337A CN200580047633A CN101111207B CN 101111207 B CN101111207 B CN 101111207B CN 2005800476337 A CN2005800476337 A CN 2005800476337A CN 200580047633 A CN200580047633 A CN 200580047633A CN 101111207 B CN101111207 B CN 101111207B
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CN
China
Prior art keywords
plate
prosthese
adaptation element
anatomic adaptation
fixture
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Expired - Fee Related
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CN2005800476337A
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English (en)
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CN101111207A (zh
Inventor
W·塞格斯
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LDR Medical SAS
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LDR Medical SAS
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Priority to CN201210011546.8A priority Critical patent/CN102551924B/zh
Publication of CN101111207A publication Critical patent/CN101111207A/zh
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0091—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type

Abstract

本发明涉及包括至少三部分的椎间盘假体，包括上板件(1)、下板件(2)和至少可相对一板件移动的芯件(3)，其中它也包括两个解剖型调节元件(11、22)，各元件一方面具有与椎骨表面接触的表面(110、220)，另一方面具有表面(111)，表面(111)至少一部分表面与安装解剖型调节元件(11或22)的板件对面的板件(1或2)的至少一部分接触，解剖型调节元件(11、22)经固定装置(113、223)固定至各板件(1、2)上。

Description

椎间盘假体
技术领域
本发明涉及旨在置换纤维软骨盘、确保脊柱椎骨间连结的椎间盘假体。
背景技术
先有技术中已知各种类型的椎间盘假体。许多假体，如专利申请WO 02 089 701和WO 2004/041129所示示例，包括绕中芯件形成笼状的下板件和上板件。部分假体允许上板件相对中芯件旋转，并可选允许中芯件相对下板件滑动。中芯件相对下板件的滑动是基本特征，因其必须允许芯件自发定位于理想位置，从而在装有假体的病人移动期间，减少施于假体的约束。芯件的位移与不平坦表面附近至少一板件的协作使得假体的板件间有倾斜度，有利于装有假体的病人的灵活性。芯件的位移也阻止其遭受主约束时在负载下变形。部分假体具有骨锚定装置，可将假体连至其间将插入假体的椎骨。
但是，对脊柱中给定位置的同一椎骨，不同人的椎骨尺寸变化很大，但对于给定的人，这取决于脊柱中其间将插入假体的椎骨的位置。椎间盘假体的尺寸必须适合其间将插入假体的椎骨，这取决于人以及脊柱中椎骨的位置。另外，根据装有假体的病人脊柱疾患，可纠正该疾患的假体有时是优选的。因此假体可用于纠正脊柱前凸等椎骨倾斜度缺陷。现有技术已知的是，特别是专利申请WO 2004/034935和DE 20320 454包括至少两个板件和至少一个芯件，其中板件的尺寸可以变化以适应假体将要植入其间的椎骨的尺寸。专利申请WO 2004/034935也描述了接触椎骨的板件表面上的凸面、斜面或圆面，用于假体和椎骨体表面之间的良好接触。因而要使假体适合尽可能多的病例，必须设想板件尺寸和倾斜度不同的大量假体。大量假体的主要不便之处在于制造成本高且库存水平高。在本文中，提出的假体的结构适用于不同尺寸的椎骨并具有不同板件倾斜度是有利的。该假体可降低库存水平和制造成本。
发明内容
本发明的目的是要提出允许假体的不同部分相互间有限移动并包括用于限制其至少一方向位移的芯件的椎间盘假体。同一假体可以以低成本调节以适合不同尺寸的椎骨。
这一目的可通过具有至少三部分的椎间盘假体实现，所述至少三部分包括上板件、下板件和至少相对一板件可移动的芯件，特征在于其包括两个解剖型调节元件，各元件一方面具有与椎骨表面接触的表面，另一方面具有这样的表面，该表面的至少一部分表面具有与板件的至少一部分接触的表面，解剖型调节元件相对于板件的至少一部分安装，解剖型调节元件经固定装置固定至各板件上。
根据另一特征，解剖型调节元件是环绕各板件的冠，并分别延长其上下表面以提供假体与相邻椎骨的接触表面，接触表面与没有解剖型调节元件时相比较大，不同尺寸解剖型调节元件的冠可在板件上调整以适用于不同尺寸的椎骨。
根据另一特征，解剖型调节元件是称为解剖型的板件，其覆盖板件并分别延长其上下表面以提供假体与相邻椎骨的接触表面，接触表面与没有解剖型调节元件时相比较大，不同尺寸解剖型调节元件的板件可在板件上调整以适用于不同尺寸的椎骨。
根据另一特征，解剖型调节元件对称地延长上下板件各自的上下表面，使表面在板件前、后、侧部不同边上的延伸相等。
根据另一特征，解剖型调节元件对称地延长上下板件各自的上下表面，使表面在板件前、后、侧边至少一边上的延伸大于在其他边上的延伸。
根据另一特征，芯件的上表面与上板件下表面的至少一部分接触，芯件的下表面与下板件上表面的至少一部分接触。
根据另一特征，至少一板件的表面的至少一部分为凹面，并且在接触芯件时与芯件的凸面互补。
根据另一特征，至少一板件的表面至少一部分为平面，并且在接触芯件时与芯件的平面互补。
根据另一特征，位于至少一板件和芯件边缘附近的公母协作装置在没有过度摩擦的情况下限制芯件相对该板件沿基本平行于板件的轴的平移，并限制或抑制芯件相对该板件绕基本垂直于板件的轴的转动。
根据另一特征，各公协作装置的尺寸稍小于各母协作装置的尺寸以使装有协作装置的芯件和板件间稍有空隙。
根据另一特征，各公协作装置的尺寸与各母协作装置的尺寸基本相同以避免装有协作装置的芯件和板件间留有空隙。
根据另一特征，板件的协作装置是与芯件的公协作装置协作的母协作装置。
根据另一特征，芯件的公协作装置是位于芯件两侧边的块件，而板件的母协作装置是位于板件两侧边中每个上的成对的四个壁。
根据另一特征，假体板件上的解剖型调节元件的固定装置可拆卸的，允许更换以可移动方式固定于假体板件的解剖型调节元件。
根据另一特征，板件上解剖型调节元件的固定装置是位于解剖型调节元件上的固定装置，并且与假体板件上的固定装置互补。
根据另一特征，解剖型调节元件一方面通过与面对板件至少一部分的表面的至少一部分接触而固定于板件上，另一方面通过固定装置与假体板件上的互补固定装置接触而固定于板件上。
根据另一特征，板件上解剖型调节元件的固定装置是位于解剖型调节元件上的公固定装置，与位于假体板件上的母固定装置协作，反之亦然。
根据另一特征，假体板件上的母固定装置是位于假体板件边缘的平面。
根据另一特征，假体板件上的母固定装置是假体另一板件边缘中形成的凹槽。
根据另一特征，假体板件上的母固定装置是假体板件的母协作装置边缘中形成的凹槽。
根据另一特征，假体板件上的母固定装置是一板件边缘上的平面和假体另一板件边缘的母协作装置中形成的凹槽。
根据另一特征，假体至少一板件上的母固定装置是板件中一个的至少第一边上的平面和假体的板件至少第二边中形成的凹槽，在几何形状上第二边面对板件的第一边。
根据另一特征，假体板件上的母固定装置中至少一个包括至少一切口以允许在该母固定装置上阻挡解剖型调节元件的公固定装置的。
根据另一特征，板件上解剖型调节元件的固定装置是位于解剖型调节元件上的母固定装置，并且与也可与假体板件上的母固定装置协作的公中间装置协作。
根据另一特征，解剖型调节元件一方面通过其上下表面的至少一部分与上下板件的至少一部分分别接触而固定于板件上，另一方面通过公中间装置与解剖型调节元件上的母固定装置接触以及与假体板件上的母固定装置接触而固定于板件上。
根据另一特征，公中间装置具有紧固装置，所述紧固装置阻挡公中间装置使之处于与解剖型调节元件上的母固定装置以及假体板件上的母固定装置协作的位置。
根据另一特征，公中间装置是解剖型调节元件上的母固定装置中的滑板，以与假体板件上的母固定装置协作，公中间装置的紧固装置是位于该板件至少一侧上的至少一形状不规则部分，并旨在与解剖型调节元件上的母固定装置中和/或板件上的母固定装置中的至少一开口协作，从而阻挡公中间装置使之处于与解剖型调节元件上的母固定装置和假体板件上的母固定装置协作的位置。
根据另一特征，公中间装置的紧固装置是解剖型调节元件的公中间装置中和母固定装置中的孔，解剖型调节元件的母固定装置中的孔可接收阻挡公中间装置使之处于与假体板件的母固定装置协作位置的紧固销。
根据另一特征，代表每个解剖型调节元件上下表面的正中面是基本平行的或形成锐角，角的倾斜度可调节假体的总体形状适合脊柱的结构或可能纠正使用假体的病人的椎骨倾斜度缺陷。
根据另一特征，相同的解剖型调节元件可与上下表面成不同角度的不同板件组装。
根据另一特征，上板件的上表面与下板件的下表面之间的角度通过代表下板件和/或上板件的上下表面的正中面形成角度而产生，或通过由协作装置限制芯件绕使板件中至少一个倾斜的位置移动而产生。
根据另一特征，相同的板件可与厚度和/或尺寸和/或形状不同的芯件组装。
根据另一特征，解剖型调节元件包括将解剖型调节元件固定至板件上、将假体插入椎骨间并可能调节假体不同元件间相对位置时固定于解剖型调节元件的可移动骨锚定元件。
根据另一特征，解剖型调节元件的可移动骨锚定元件是配有被定向以在插入椎骨后阻止拆除板件的切口的至少一板件，板件的远端具有弯曲折叠其上的部分，并旨在用作钩子以与制于解剖型调节元件外周附近的开口的边缘互锁。
根据另一特征，解剖型调节元件的可移动骨锚定元件的具有切口的板件的弯曲折叠其上的部分与也配有被定向以在插入椎骨后阻止拆除板件的切口的第二板件共同延长。
根据另一特征，解剖型调节元件包括的可移动骨锚定元件是插入其间将植入假体的椎骨相邻表面的槽内的至少一个小翼，所述小翼包括被定向以阻止假体弹出椎骨间外壳的切口，小翼的远端具有弯曲折叠其上的部分，并旨在用作钩子以与解剖型调节元件外周附近的开口的边缘互锁。
根据另一特征，小翼还包括尺寸可调节以紧密插入解剖型调节元件和/或板件的槽内的销。
附图说明
通过下文参照附图所述说明，本发明的其他特征和优点将更加明显，其中：-图1示出了根据本发明实施例的假体的不同元件的分解透视图，-图2示出了根据本发明另一实施例的假体的不同元件的分解透视图，-图3示出了根据本发明另一实施例的假体的透视图。-图4A和4B分别示出了根据本发明实施例的装有解剖型调节元件的上板件的仰视图和沿图4A所示平面A-A所截剖视图，图4C和4D分别示出了根据本发明实施例的装有解剖型调节元件的上板件的平面图和沿图4C所示平面B-B所截剖视图，-图5A示出了根据本发明实施例的装有解剖型调节元件的上板件的仰视图，图5B和5C分别示出了根据本发明实施例的装有解剖型调节元件的上板件的沿图5A所示平面C-C和平面D-D所截剖视图，-图6A和6B示出了根据本发明两个不同实施例的装有解剖型调节元件的上板件部分仰视图，-图7A和7B示出了根据本发明两个不同实施例的装有解剖型调节元件的下板件的透视图。-图8A和8B分别示出了根据本发明实施例的装有解剖型调节元件且其固定装置打开的下板件部分仰视图和沿图8A所示平面E-E所截剖视图，图8C和8D分别示出了与图8A和8B所示相同实施例的仰视图和沿图8C所示平面F-F所截剖视图，但根据本发明实施例的解剖型调节元件的固定装置关闭并锁定，-图9A和9B分别示出了根据本发明实施例的装有解剖型调节元件且其固定装置打开的下板件部分仰视图和沿图9A所示平面G-G所截剖视图，图9C和9D分别示出了与图9A和9B所示相同实施例的仰视图和沿图9C所示平面H-H所截剖视图，但根据本发明实施例的解剖型调节元件的固定装置关闭并锁定，-图10A和10B分别示出了根据本发明实施例的包括骨锚定装置的假体和根据该实施例的一骨锚定装置的透视图，-图11A和11B分别示出了根据本发明实施例的包括骨锚定装置的假体的透视图和沿图11A所示平面I-I所截剖视图。
具体实施方式
根据本发明的椎间盘假体包括通过芯件3与下板件2相连的上板件1，各板件1、2装有解剖型调节元件11、22，从而允许调节假体的总尺寸使之适合其间将被插入假体的椎骨尺寸。因此，由于解剖型调节元件11、22，由两块板件1、2和芯件3组成的单个单元可被用于不同尺寸的椎骨，这大幅减少了制造假体及其变体的成本。根据本发明的假体的优点在于其包括的简单部件的解剖型调节元件11、22可变化尺寸以适合脊柱的不同椎骨，如调节假体的厚度以适合椎间隙和/或调节假体的板件1、2的倾斜度以适合病人椎骨的倾斜度。尽管解剖型调节元件11、22可调节假体适合不同尺寸的椎骨，如果需要，自然可使用不同尺寸和形状的板件1、2和芯件3。
根据本发明的假体的两个解剖型调节元件11、22是上元件11和下元件22。上元件11一方面上表面110至少部分与第一椎骨的下表面接触，另一方面下表面111至少部分与上板件1的部分接触。下元件22一方面下表面220至少部分与第二椎骨的上表面接触，另一方面上表面222至少部分与下板件2的部分接触。两个解剖型调节元件11、22中每个均通过各自固定装置113、223固定于板件1、2。
芯件3稍有厚度(3至15毫米，取决于其间将插入假体的椎骨)。为了较好的吸收约束，芯件可由模仿自然椎间盘弹性的物理属性的可压缩材料例如聚乙烯制成。
在本发明的所有可能实施例中，芯件3在其上表面30和下表面34中至少一个的至少一部分上具有凸面部分。在图1至9所示实施例中，芯件3的上表面30为凸面部分，其与上板件1的下表面14的凹面部分140互补，而芯件3的下表面34为平面部分，其与下板件2上表面24的平面至少一个部分互补。上板件1的下表面14的凹面部分140，如图4A、4B、5A、5B和5C特别直观所示，具有圆形外周。在其它可能的实施例(未示出)中，芯件3的下表面34为凸面部分，其与下板件2上表面24的凹面部分互补，而芯件3的上表面30为平面部分，其与上板件1的下表面14的至少一个平面部分互补。在其它实施例(未示出)中，凹面位于芯件3的上表面30和下表面34中一表面的一部分上，与位于板件1、2中一板件的表面的一部分上的凸面协作。在本发明的不同可能实施例(未示出)中，芯件3的非凸面或非凹面可分别为例如稍有凹起或凸进。
在图1至图9所示实施例中，装有假体的病人俯身时，与芯件3的凸面部分互补的上板件1的下表面14的凹面部分140可倾斜上板件1。由于上板件1相对芯件3倾斜，凹面部分140与凸面34间的协作提供了与假体的连接面。连接的中心自然是芯件3的凸面34顶端。在所示实施例中，芯件3的下表面和下板件2的上表面为平面，以允许芯件3相对下板件2沿基本平行下板件2的轴平移和绕基本垂直下板件2的轴旋转时有空隙。在装有假体的病人移动期间，上板件1的倾斜度和芯件的空隙允许芯件3朝向吸收施于假体约束的理想位置移动。因此上板件1和芯件3之间的移动以及芯件3相对下板件2的空隙允许病人移动并可选地消除假体定位的缺陷。空隙同样具有防止假体因施于假体的约束磨损过快。
不考虑本实施例，芯件3也具有分别与板件1、2中至少一个的母或公协作装置23互补的公或母协作装置33。位于至少一板件1、2和芯件3边缘附近的公、母协作装置23、33在没有过度摩擦的情况下限制芯件3相对板件1、2沿基本平行板件1、2的轴平移，并限制或抑制芯件3相对板件1、2绕基本垂直板件1、2的轴旋转。各公协作装置33的尺寸稍小于各母协作装置23的尺寸以允许装有协作装置的芯件3和板件1、2之间稍有空隙。相反，各公协作装置33也可与各母协作装置23尺寸基本相同，以防止装有协作装置的芯件3和板件1、2之间留有空隙。
在图1至3所示实施例中，芯件3具有与下板件2上的母协作装置23互补的公协作装置33。芯件3的公协作装置33是，例如，出现在芯件3侧边上形状为基本平行六面体的搭扣或块件，如图1至3特别直观所示。母协作装置23是，例如，成对位于下板件2两侧边中每个边上的四个壁。壁可朝向假体的中心弯曲，以覆盖芯件3的公协作装置33的至少一部分，并避免提升芯件3和上板件1。协作装置23、33还防止芯片3在假体上约束过多时弹出假体。在另一实施例(未示出)中，芯件3的各公协作装置33尺寸与下板件2的各母协作装置23的尺寸基本相同，以避免芯件3相对下板件2平移和旋转时留有空隙。在后种情况下，假体仅允许上板件1相对芯件3倾斜。在另一实施例(未示出)中，芯件3具有的母协作装置是例如下板件2上的公装置的互补凹槽。下板件2上的公装置可包括如下板件2的两边上向假体内部弯曲并相互面对的两个块件或两个突边。突边例如可被换成具有孔的块件，通过销穿过孔而将搭扣固定至所述孔。在另一实施例(未示出)中，下板件2具有圆底端。通过互补，芯件3下表面下具有井。根据所需结果下板件2的半圆底端和芯件3的井的尺寸可出于选择以根据平移和旋转中芯件3稍有空隙或没有空隙来进行调节。在其它实施例(未示出)中，协作装置可位于芯件3和上板件1上，而不是下板件2上。
现参照图1说明第一实施例。在此实施例中，上解剖型调节元件11和下解剖型调节元件22是称为解剖型的板件，其分别覆盖上板件1和下板件2。上解剖型调节元件11和下解剖型调节元件22的各上表面222和下表面111具有分别容纳下板件2和上板件1的构架。在另一实施例中，解剖型调节元件的各上表面222和下表面111可为平面并包括制动器，其对于前述构架而言，分别阻止下板件2和上板件1相对解剖型调节元件移动。下解剖型调节元件22和上解剖型调节元件11各自的上表面222和下表面111分别延长上板件1和下板件2的上表面10和下表面20以提供假体和相邻椎骨的接触表面，接触表面与没有解剖型调节元件11、22时相比较大。解剖型调节元件11、22的解剖型板件的不同尺寸可调节适用于两块板件1、2和芯件3制成的单个单元，以提供假体和不同尺寸椎骨间的良好接触。
在图2所示根据本发明的假体实施例中，解剖型调节元件11、22是环绕上板件1和下板件2的冠。在此实施例中，上板件1和下板件2的上表面10和下表面20的各边倾斜并分别与上冠11和下冠22的各自的下内侧边111和上内侧边222互补。板件1、2的边以及解剖型调节冠11、22的倾斜形状与解剖型调节元件的固定装置113、223协作以保持解剖型调节冠11、22分别固定于假体上板件1和下板件2的平面。解剖型调节冠11、22分别延长上板件1和下板件2的上表面10和下表面20以提供假体和相邻椎骨间的接触表面，接触表面与没有解剖型调节元件11、22时相比较大。与前述解剖型板件11、22相同，由于解剖型调节元件11、22的冠的不同尺寸，由两块板件1、2和芯件3制成的单个单元可调节以适合不同尺寸的椎骨。
在本发明的所有实施例中，解剖型调节元件11、22可对称或不对称地延长上板件1和下板件2各自的上表面10和下表面20。因而，例如，解剖型调节元件11、22的前边与椎骨的接触表面可大于后边与椎骨的接触表面，使得(上述)假体的连接中心位于相对脊柱自然轴的中心，即偏心至椎骨后部2/3-1/3部分。
根据所选实施例，根据本发明的椎间盘假体例如可纠正脊柱前凸缺陷。与相邻椎骨接触的假体上下表面间需要存在角度。该角度可通过制造代表下表面14和上表面10的正中面形成角度的上板件1获得。另一可能是下板件2的代表下表面20和上表面24的正中面形成角度。另一可能是解剖型调节元件11、22至少一个的代表下、上表面的正中面形成角度。因而可使用由两块板件1、2和芯件3制成的单个单元来引导或不引导脊柱前凸，取决于与其相关的解剖型调节元件11、12。在图3所示实施例中，下解剖型板件22的下表面220与上表面222形成角度。获得该角度的另一可能是芯件3相对假体中心的稍稍偏移的位置。芯件3稍偏移的位置可由例如公母协作装置23、33在其间的可调节定位而保持。如果外科医生期望，例如，假体引导保持于一定范围值内的脊柱前凸，由于芯件3和下板件2之间协作装置23、33的精确调节，他选择的假体的芯件3绕使至少一板件稍稍持久倾斜的位置相对下板件2平移和旋转中稍有空隙。因而，根据所选实施例，代表各解剖型调节元件11、22的上表面110、222和下表面111、220的正中面可基本平行或形成锐角。该角度所获倾斜允许调节假体的总体形状，以适合脊柱的结构或可能纠正使用假体的病人的椎骨倾斜度缺陷。相同解剖型调节元件11、22可与不同板件1、2组装在一起，所述板件1、2的上表面10、24和下表面14、20形成不同角度。相反，上表面10、24和下表面14、20平行的板件1、2与上表面110、222和下表面111、220形成不同角度的解剖型调节元件11、22组装在一起。上板件1的上表面10和下板件2的下表面20之间的角可通过代表下板件2和/或上板件1的下表面20、14和上表面24、10的正中面形成角度而产生，或通过由协作装置23、33限制芯件3绕使板件1、2中至少一个倾斜的位置移动而产生。
图1至3示出了解剖型调节元件11、22的可移动骨锚定装置60。骨锚定装置60可在将其固定至板件1、2时尤其是将假体插入椎骨间时被固定于解剖型调节元件11、22。这一特征允许外科医生轻松定位假体于椎骨间，然后一旦假体已正确定位就插入骨锚定装置60。在图1所示实施例中，可移动骨锚定装置60是配有插入椎骨后阻止拆除板件的切口62的板件61。板件61可由例如具有或不具有阻止拆除板件的切口的钉形杆替换。板件61的远端具有弯曲折叠其上的部分63。弯曲部分63形成钩形，旨在与解剖型调节元件11、22外周附近的开口的边缘16、26互锁。开口的边缘16、26形成骨锚定装置60互锁的杆形。实际上，弯曲部分63允许骨锚定装置60扣紧解剖型调节元件11、22的杆16、26。杆可替换为可扣紧骨锚定装置60的任何等效装置。在图1至9所示实施例中，杆16、26位于解剖型调节元件11、22的前边，以在假体经前部装置(通过从前面进入椎骨)插入椎骨间后允许外科医生使用。如果假体的移植将通过后部装置完成，解剖型调节元件11、22可具有位于其后缘的杆16、26。如果假体的移植将通过后部装置完成，解剖型调节元件11、22可具有位于其至少一个边的杆16、26。在图2至3所示实施例中，解剖型调节元件11、22的可移动骨锚定装置60的具有切口的板件61的弯曲折叠其上的钩形部分63与同样配有插入椎骨后阻止拆除板件61的切口62的第二板件61共同延长。在图2所示实施例中，第二板件61与第一板件相比较短，而在图3所示实施例中，第二板件61与第一板件相比较长。骨锚定装置60锁紧于杆16、26使其具有有利于假体连接的可变角。实际上，根据障碍，外科医生可选择期望将骨锚定装置60引入椎骨的角度。另外，可在定位假体于椎骨间后插入骨锚定装置60使得假体的不同元件1、2、3的相对位置可以调节。实际上，假体的插入在假体的元件上产生约束，所述元件互相可移动，并且它们有定位不佳的危险。由于本发明，外科医生可在确定连接假体前调节假体元件间的相对位置。
很明显，该假体可包括上述装置外的其它骨锚定装置60，而不背离本发明的范围。为了给出非限制性示例，该骨锚定装置60可包括如专利申请第WO03/039400所示固定于假体的小翼或如专利申请第WO04/041129所示经解剖型调节元件钉入椎骨的双头螺柱。图10A、10B、11A和11B示出了锚定装置60的一实施例。根据本实施例的骨锚定装置60由包括弯曲折叠其上的钩形部分63的小翼组成，使得小翼可适用于解剖型调节元件。小翼的钩形部分63，如图10B特别直观所示，允许锚定装置60与解剖型调节元件11、22外周附近开口的边缘16、26互锁，如图11A和11B特别直观所示。开口的边缘16、26形成一种骨锚定装置60于其上互锁的杆，如上所述。小翼还包括可插入出现在板件和/或解剖型调节元件表面上的槽的销64(或榫钉)，其中小翼将被固定于所述槽上，如图11B特别直观所示。槽65和销64的尺寸可调节以使销64固定于槽65。例如，销64可为基本圆锥形，锥体较大直径位于销的底部，较小直径位于其末端。槽65的侧壁可调节，与销64的锥形协作，使得销可紧密插入槽内，从而固定骨锚定装置60至解剖型调节元件11、22。例如，槽65表面的宽度可大于其底面宽度。通过首先将钩形部分63互锁至解剖型调节元件11、22的杆16、26，之后绕杆旋转骨锚定装置60直至销64紧密伸入解剖型调节元件11、22和/或板件1、2的槽65，从而固定骨锚定装置60至本发明的假体。对于本发明的所有假体，小翼60可为标准尺寸，小翼60的销64在槽65内的位置可作为解剖型调节元件11、22的尺寸的函数而变化。根据解剖型调节元件11、22的厚度，销64仅伸入解剖型调节元件11、22内或可横穿解剖型调节元件11、22并伸入板件1、2中的槽65内，如图11bB上板件1示例所示。由于解剖型调节元件11、22的尺寸(直径)可变化，其槽长度也可变化，并可由与杆16、26距离可变以使孔可接收销64的孔替换，但当销设计为伸入板件时，板件应包括槽，因为销与板件外周的距离取决于解剖型调节元件11、22的尺寸。一旦固定至解剖型调节元件11、22上，小翼60可与接触的相邻椎骨表面钻的槽协作。因而，外科医生可在其间将插入假体的椎骨表面开槽。椎骨中的槽自然根据小翼的位置和方相对矢形面定向。该方向应预先确定，并将设置和固定假体的方向。同样，椎骨中槽的深度及其从外周的伸出也作为小翼60尺寸的函数而预先确定，并将允许外科医生调节假体各元件的相对位置，并预测假体相对椎骨自然轴的位置。小翼包括将与椎骨中所开槽底面接触的表面上的切口66。小翼60的切口66将阻止假体从椎骨间外壳中弹出，例如当假体受到强约束时。很明显，尤其根据示出两个实施例的图11B，小翼60的钩形部分63可定向以使其可通过插入解剖型调节元件11、22外周附近的开口内或通过从开口外侧插入而互锁至杆16、26上。
很明显，上述骨锚定装置60可特别调节以适合本发明的解剖型调节元件11、22，但也可调节以适合板件外周附近包括开口的其它类型椎间盘假体的板件。板件中这样的开口的边缘16、26形成一种杆16、26，骨锚定装置60的两个可拆除实施例中钩形部分可互锁于杆16、26上。
图4至9示出了横向配有解剖型调节元件11、22的假体的板件1、2并定义板件1、2上的解剖型调节元件11、22的固定装置113、223、15、25的不同实施例。固定装置113、223、15、25可拆除的，这意味着解剖型调节元件11、22可轻松连至假体板件1、2并从假体板件1、2拆除。固定装置113、223、15、25允许更换以可移动方式固定至板件1、2的解剖型调节元件11、22。板件1、2上解剖型调节元件11、22的固定装置113、223、15、25是位于解剖型调节元件11、22上并与位于假体板件1、2上的固定装置15、25互补的固定装置113、223。解剖型调节元件11、22一方面经其下表面111和上表面222至少一部分与上板件1和下板件2至少一部分分别接触从而固定至板件1、2上，另一方面经其固定装置113、223与位于假体板件1、2上的互补固定装置15、25接触从而固定至板件1、2上。对于如图4A至4D所示解剖型板件11、22，因上板件1和下板件2各自的上表面10和下表面20经固定装置113、223、15、25稳固连于位于上解剖型板件11和下解剖型板件22各自的上表面111和下表面222的构架，可使解剖型调节元件11、22固定至板件1、2上。对于如图5A至5C所示解剖型冠11、22，因上板件1和下板件2各自的上表面10和下表面20的倾斜部分经固定装置113、223、15、25稳固连于上解剖型板件11和下解剖型板件22各自的上表面111和下表面222的倾斜部分，可使解剖型调节元件11、22固定至板件1、2上。现参照图4至9说明板件1、2上解剖型调节元件11、22的固定装置113、223、15、25的不同实施例。很明显固定装置以示例形式给出，可由任何等效装置替换而不背离本发明的范围。同样，本发明允许使用下述不同固定装置113、223、15、25的任何组合。
在一些实施例中，板件1、2上解剖型调节元件11、22的固定装置113、223、15、25是位于解剖型调节元件11、22并与位于假体板件1、2上的母固定装置15、25协作的公固定装置113、223。位于假体板件1、2上的母固定装置15、25可为例如位于假体板件1、2边缘上的平面15、25，或制于假体板件1、2边缘中15、25或假体板件1、2的母协作装置23边缘中的凹槽15、25。
在图4A和4B所示实施例中，在下表面111后边上，解剖型板件11的固定装置113是突边，其被定形且具有一定尺寸以接收上板件1下表面14后边的部分15。在下表面111前边上，解剖型板件11的固定装置113是具有装有搭扣的旋转轴的插销，所述搭扣可绕该轴旋转并接收上板件1下表面14后边的部分15，如图4A和4B特别直观所示。图4A至4C所示右插销处于打开位置，左插销处于关闭位置。在图4C和4D所示实施例中，在下表面222后边上，下解剖型板件22的固定装置223是突边，其被定形且具有一定尺寸以适合插入制于下板件2协作装置23的开口25内。在下表面222前边上，上解剖型板件22的固定装置223是具有旋转轴的插销，所述旋转轴之上装有搭扣以接收位于下板件2后边协作装置23部分中的凹槽25。图4A至4D所示插销可由如位于假体板件1、2上的紧固装置55保持在关闭位置。例如，如图4C所示，位于下板件2协作装置23的一部分上的凹槽25上的切口55阻止下解剖型板件22的插销223回转。
在图5A至5C所示实施例中，上解剖型调节冠11的前后边具有为突边的固定装置113，所述突边与位于上板件下表面14边缘的平面部分15协作。
在图6A至9D所示实施例中，板件1、2上解剖型调节元件11、22的固定装置113、223、15、25是位于解剖型调节元件11、22上、与公中间装置50协作的母固定装置113、223，公中间装置50也与位于假体板件1、2上的母固定装置15、25协作。解剖型调节元件11、22一方面经其上表面111和下表面222至少一部分与上板件1和下板件2至少一部分分别接触从而固定至板件1、2上，另一方面经其公中间装置50与位于解剖型调节元件11、22上的母固定装置113、223以及假体板件1、2上的母固定装置15、25接触从而固定至板件1、2上。公中间装置50是位于解剖型调节元件11、22上的母固定装置113、223中的滑动板件50，以与位于假体板件1、2上的母固定装置15、25协作。板件50为平行六面体形状，其侧边上可包括翼片500，如图7A特别直观所示。公中间装置50的翼片500与具有翼片500可滑动的滑道的解剖型调节元件11、22上的母固定装置113、223以及假体板件1、2上的母固定装置15、25形状互补。板件50的翼片500与解剖型调节元件11、22上的母固定装置113、223以及板件1、2上的母固定装置15、25的滑道的互补形状阻止板件50在经紧固装置55阻挡前脱离母固定装置113、223、15、25。
公中间装置50具有阻挡公中间装置50使之处于与解剖型调节元件11、22上的母固定装置113、223以及假体板件1、2上的母固定装置15、25协作位置的紧固装置55。紧固装置55是例如位于板件50至少一侧的至少一形状不规则部分55，并旨在与解剖型调节元件11、22的母固定装置113、223中和/或板件1、2的母固定装置15、25中的至少一开口550协作。开口550可与公中间装置50或其紧固装置的形状互补，如图6A和6B所示。
在图6A所示实施例中，具有公中间装置50的板件朝向后端加宽，具有紧固装置55的形状不规则部分是位于板件50后半部分的切口。切口55被引入上和/或下解剖型调节元件11、22的母固定装置113、223时压缩板件50的后端，如图6A左板件所示。板件50到达解剖型调节元件11、22的母装置113、223和板件1、2的装置15、25产生的滑道行程末端时，这意味着当其与两种母装置同时协作时，例如解剖型调节元件11、22的母装置113、223上的开口550从该点分开板件50，如图6A右板件所示。图7B示出了固定装置实施例的透视图，在所述固定装置中板件50旨在保持于下板件2的协作装置23的母装置25中。该图也特别示出了位于如下解剖型板件22上的构架，所述构架的厚度可大于下板件2的厚度。根据芯件3的下板件2的协作装置23、33的尺寸，该构架边缘可提供外周挡部，以限制芯件3相对下板件2的位移。在图6B所示实施例中，组成公中间装置50的紧固装置55的形状不规则部分是位于板件50侧边上的搭扣。如图6B中左板件所示，当搭扣被引入母装置113、223的滑道中时，搭扣55受压。当板件被推至阻挡位置，搭扣55在位于上和/或下解剖型调节元件11、22的母装置113、223侧边的开口550中自然打开，如图6B右板件50所示。
图7A以及图8A至8D示出了公中间装置50的另一可选实施例。在此实施例中，组成板件50的紧固装置55的板件50的形状不规则部分是公中间装置50中的孔，其由解剖型调节元件11、22的母固定装置113、223的孔550延长，如图8B特别直观所示。孔550旨在接收紧固销55，所述紧固销在它们与位于假体板件1、2上的母固定装置协作的位置阻挡公中间装置50，如图8C所示。
图9A至9D示出了公中间装置50的紧固装置55另一可选实施例。在此实施例中，组成板件50的紧固装置55的形状不规则部分是位于板件下表面的切口55，一旦推至板件1、2的母固定装置15、25就通过阻止拆除板件50来与解剖型调节元件的母固定装置113、223中的开口550协作，如图9D所示。
对于专业人员，很明显本发明具有众多其它具体形式但不背离本发明申请所要求范围的实施例。因此，实施例仅是示例性的，可在权利要求界定范围内修改，本发明无须受上述详细说明限制。

Claims (37)

1.一种椎间盘假体，包括至少三部分，包括上板件(1)、下板件(2)和至少相对一板件可移动的芯件(3)，特征在于其包括两个解剖型调节元件(11、22)，该元件延伸假体的直径和/或高度，各调节元件(11、22)一方面具有与椎骨表面接触的表面(110、220)，另一方面具有这样的表面(111)，该表面的至少一部分具有与板件(1、2)的至少一部分接触的表面，所述解剖型调节元件(11、22)相对于所述板件(1、2)的至少一部分安装，所述解剖型调节元件(11、22)经固定装置(113、223)固定至所述板件(1、2)上。
2.根据权利要求1的椎间盘假体，其中所述解剖型调节元件(11、22)是环绕所述板件(1和2)的冠，并分别延长其上表面(10)和下表面(20)以提供所述假体与相邻椎骨的接触表面，接触表面与没有解剖型调节元件(11、22)时相比较大，不同尺寸的所述解剖型调节元件(11、22)的冠可在所述板件上调整以适用于不同尺寸的椎骨。
3.根据权利要求1的椎间盘假体，其中解剖型调节元件(11、22)是称为解剖型的板件，其覆盖所述板件(1和2)并分别延长其上表面(10)和下表面(20)以提供所述假体与相邻椎骨的接触表面，接触表面与没有解剖型调节元件(11、22)时相比较大，不同尺寸的所述解剖型调节元件的板件可在所述板件上调整以适用于不同尺寸的椎骨。
4.根据权利要求1的椎间盘假体，其中所述解剖型调节元件(11、22)对称地延长所述上板件(1)和所述下板件(2)各自的上表面(10)和下表面(20)，使表面(10、20)在所述板件(1、2)前、后、侧部不同边上的延伸相同。
5.根据权利要求1的椎间盘假体，其中所述解剖型调节元件(11、22)不对称地延长上板件(1)和下板件(2)各自的上表面(10)和下表面(20)，使表面(10、20)在所述板件(1、2)前、后、侧边至少一边上的延伸大于在其他边上的延伸。
6.根据权利要求1的椎间盘假体，其中所述芯件(3)的上表面(30)与所述上板件(1)下表面(14)的至少一部分接触，所述芯件(3)的下表面(34)与所述下板件(2)上表面(24)的至少一部分接触。
7.根据权利要求1的椎间盘假体，其中至少一板件(1、2)的表面(14、24)的至少一部分(140)为凹面，并且与其接触的所述芯件(3)的凸面(30)互补。
8.根据权利要求1的椎间盘假体，其中至少一个板件(1、2)的表面(14、24)的所述至少一部分为平面，并且与其接触的所述芯件(3)的平面(34)互补。
9.根据权利要求1的椎间盘假体，其中位于至少一板件(1、2)和芯件(3)边缘附近的公母协作装置(23、33)限制芯件(3)相对该板件(1、2)沿基本平行于板件(1、2)的轴的平移，并限制或抑制芯件(3)相对该板件(1、2)绕基本垂直于板件(1、2)的轴的转动。
10.根据权利要求9的椎间盘假体，其中各公协作装置(33)的尺寸稍小于各母协作装置(23)的尺寸以使装有协作装置的所述芯件(3)和所述板件(1、2)间稍有空隙。
11.根据权利要求9的椎间盘假体，其中各公协作装置(33)的尺寸与各母协作装置(23)的尺寸基本相同以避免装有协作装置的所述芯件(3)和所述板件(1、2)间留有空隙。
12.根据权利要求9的椎间盘假体，其中所述板件(1、2)的协作装置(23)是与所述芯件(3)的公协作装置(33)协作的母协作装置。
13.根据权利要求12的椎间盘假体，其中所述芯件(3)的所述公协作装置(33)是位于所述芯件(3)两侧边的两个块件，而所述板件(1、2)的所述母协作装置(23)是位于所述板件(1、2)两侧边中每个上成对的四个壁。
14.根据权利要求1的椎间盘假体，其中所述假体的所述板件(1、2)上的所述解剖型调节元件(11、22)的所述固定装置(113、223、15、25)是可拆卸的，允许更换以可移动方式固定于所述假体的所述板件(1、2)的所述解剖型调节元件(11、22)。
15.根据权利要求1的椎间盘假体，其中所述板件(1、2)上的所述解剖型调节元件(11、22)的所述固定装置(113、223、15、25)是位于所述解剖型调节元件(11、22)上的固定装置(113、223)，并且与所述假体的所述板件(1、2)上的固定装置(15、25)互补。
16.根据权利要求15的椎间盘假体，其中所述解剖型调节元件(11、22)一方面通过与面对所述板件(1、2)至少一部分的表面(111和222)的至少一部分接触而固定于所述板件(1、2)上，另一方面通过固定装置(113、223)与所述假体的所述板件(1、2)上的所述互补固定装置(15、25)接触而固定于所述板件(1、2)上。
17.根据权利要求15的椎间盘假体，其中所述板件(1、2)上的所述解剖型调节元件(11、22)的所述固定装置(113、223、15、25)是位于所述解剖型调节元件(11、22)上的公固定装置(113、223)，并与位于所述假体的所述板件(1、2)上的母固定装置(15、25)协作，反之亦然。
18.根据权利要求17的椎间盘假体，其中所述假体的所述板件(1、2)上的所述母固定装置(15、25)是位于所述假体的所述板件(1、2)边缘的平面(15、25)。
19.根据权利要求17的椎间盘假体，其中所述假体的所述板件(1、2)上的所述母固定装置(15、25)是所述假体板件(1、2)边缘中形成的凹槽(15、25)。
20.根据权利要求17的椎间盘假体，其中所述假体的所述板件(1、2)上的所述母固定装置(15、25)是所述假体的所述板件(1、2)的所述母协作装置(23)边缘中形成的凹槽。
21.根据权利要求17的椎间盘假体，其中所述假体的所述板件(1、2)上的所述母固定装置(15、25)是一板件(1)边缘上的平面(15)和所述假体的另一板件(2)边缘的所述母协作装置(23)中形成的凹槽(25)。
22.根据权利要求17的椎间盘假体，其中所述假体至少一板件(1、2)上的所述母固定装置(15、25)是所述板件(1、2)中一个的至少第一边上的平面(15、25)和所述假体的所述板件(1、2)至少第二边中形成的凹槽(15、25)，在几何形状上所述第二边面对所述板件(1、2)的所述第一边。
23.根据权利要求17的椎间盘假体，其中所述假体的所述板件(1、2)上的所述母固定装置(15、25)中至少一个包括至少一个切口(55)以允许在该母固定装置(15、25)上阻挡所述解剖型调节元件(11、22)的所述公固定装置(113、223)。
24.根据权利要求1的椎间盘假体，其中所述板件(1、2)上的所述解剖型调节元件(11、22)的所述固定装置(113、223、15、25)是位于所述解剖型调节元件(11、22)上的母固定装置(113、223)，并且与也与所述假体的所述板件(1、2)上的所述母固定装置(15、25)协作的所述公中间装置(50)协作。
25.根据权利要求24的椎间盘假体，其中所述解剖型调节元件(11、22)一方面通过其上表面(111)和下表面(222)的至少一部分分别与所述上板件(1)和所述下板件(2)的至少一部分接触而固定于所述板件(1、2)上，另一方面通过所述公中间装置(50)与所述解剖型调节元件(11、22)上的所述母固定装置(113、223)接触以及与所述假体的所述板件(1、2)上的所述母固定装置(15、25)接触而固定于所述板件(1、2)上。
26.根据权利要求24的椎间盘假体，其中所述公中间装置(50)具有紧固装置(55)，所述紧固装置(55)阻挡所述公中间装置(50)使之处于与所述解剖型调节元件(11、22)上的所述母固定装置(113、223)以及所述假体的所述板件(1、2)上的所述母固定装置(15、25)协作的位置。
27.根据权利要求26的椎间盘假体，其中所述公中间装置(50)是所述解剖型调节元件(11、22)上的所述母固定装置(113、223)中的滑板(50)，以与所述假体的所述板件(1、2)上的所述母固定装置(15、25)协作，所述公中间装置(50)的所述紧固装置(55)是位于该滑板(50)至少一侧上的至少一形状不规则部分(55)并旨在与所述解剖型调节元件(11、22)上的所述母固定装置(113、223)中和/或所述板件(1、2)上的所述母固定装置(15、25)中的至少一开口(550)协作，从而阻挡由该滑板(50)形成的所述公中间装置使之处于与所述解剖型调节元件(11、22)上的所述母固定装置(113、223)和所述假体的所述板件(1、2)上的所述母固定装置(15、25)协作的位置。
28.根据权利要求26的椎间盘假体，其中所述公中间装置(50)的所述紧固装置(55)是所述解剖型调节元件(11、22)上的所述公中间装置(50)中和所述母固定装置(113、223)中的孔，所述解剖型调节元件(11、22)的所述母固定装置(113、223)中的所述孔(550)可接收阻挡所述公中间装置(50)使之处于与所述假体的所述板件(1、2)上的所述母固定装置(15、25)协作位置的紧固销(55)。
29.根据权利要求1的椎间盘假体，其中代表所述解剖型调节元件(11、22)的至少一个的所述上表面(110、222)和所述下表面(111、220)的正中面是基本平行的或形成锐角，角的倾斜度可调节所述假体的总体形状适合脊柱的结构或可能纠正使用所述假体的病人的椎骨倾斜度缺陷。
30.根据权利要求1的椎间盘假体，其中相同的解剖型调节元件(11、22)可与上表面(10、24)和下表面(14、20)成不同角度的不同板件(1、2)组装。
31.根据权利要求9的椎间盘假体，其中所述上板件(1)的所述上表面(10)与所述下板件(2)的所述下表面(20)之间的角度通过代表所述下板件(2)和/或所述上板件(1)的所述下表面(20、14)和所述上表面(24、10)的正中面形成角度而产生，或通过由所述协作装置(23、33)限制所述芯件(3)绕使所述板件(1、2)的至少一个倾斜的位置移动而产生。
32.根据权利要求1的椎间盘假体，其中相同的板件(1、2)可与厚度和/或尺寸和/或形状不同的芯件(3)组装。
33.根据权利要求1的椎间盘假体，其中所述解剖型调节元件(11、22)包括将所述解剖型调节元件(11、22)固定至所述板件(1、2)上、将所述假体插入椎骨间并可能调节所述假体的不同元件(1、2、3)间相对位置时固定于所述解剖型调节元件(11、22)的可移动骨锚定元件(60)。
34.根据权利要求33的椎间盘假体，其中所述解剖型调节元件(11、22)的可移动骨锚定元件(60)是配有被定向以在插入椎骨后阻止拆除板件(61)的切口(62)的至少一板件(61)，所述板件(61)的远端具有弯曲折叠其上的部分(63)，并旨在用作钩子以与制于所述解剖型调节元件(11、22)外周附近的开口的边缘(16、26)互锁。
35.根据权利要求34的椎间盘假体，其中所述解剖型调节元件(11、22)的所述可移动骨锚定元件(60)的具有切口的板件(61)的弯曲折叠其上的部分(63)与也配有被定向以在插入椎骨后阻止拆除板件(61)的切口(62)的第二板件(61)共同延长。
36.根据权利要求1的椎间盘假体，其中所述解剖型调节元件(11、22)包括的可移动骨锚定元件(60)是插入其间将植入所述假体的椎骨相邻表面的槽内的至少一个小翼，所述小翼包括被定向以阻止所述假体弹出所述椎骨间外壳的切口(66)，所述小翼(60)的远端具有弯曲折叠其上的部分(63)，并旨在用作钩子以与所述解剖型调节元件(11、22)外周附近的开口的边缘(16、26)互锁。
37.根据权利要求36的椎间盘假体，其中所述小翼(60)还包括尺寸可调节以紧密插入所述解剖型调节元件(11、22)和/或所述板件(1、2)的槽(65)内的销(64)。
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