CN1387423A - 铰接的脊柱植入物 - Google Patents

铰接的脊柱植入物 Download PDF

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Publication number
CN1387423A
CN1387423A CN00815243A CN00815243A CN1387423A CN 1387423 A CN1387423 A CN 1387423A CN 00815243 A CN00815243 A CN 00815243A CN 00815243 A CN00815243 A CN 00815243A CN 1387423 A CN1387423 A CN 1387423A
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CN
China
Prior art keywords
spinal implant
vertebra
hinged
implant
chamber
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN00815243A
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English (en)
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CN1262253C (zh
Inventor
J·C·考特恩
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Warsaw Orthopedic Inc
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SDGI Holdings Inc
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Publication of CN1387423A publication Critical patent/CN1387423A/zh
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Publication of CN1262253C publication Critical patent/CN1262253C/zh
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    • A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
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Abstract

一种用于椎间盘复位的脊柱植入物(10)。植入物由两个半圆柱形元件(20、22)构成,每个元件与相邻的成对脊椎(12、14)之一接触。一铰接的球与穴接头和/或摇杆以及两元件之间的通道抵抗脊椎之间的压力和阻止侧向运动,但允许枢转运动,藉此防止移位。融合室(30、34)可使骨头向内生长以使诸元件与脊椎融合。生物相容的、可生物吸收的支柱、填隙片(82)、垫片和/或端盖(90)可使第一(20)与第二(22)半圆柱形元件临时稳定。可将移植期间从脊椎上去除的骨碎片或骨生长激励器插入融合室,或将其它方法应用于植入物以使骨头向内生长。

Description

铰接的脊柱植入物
供参照的相关申请
本申请是1999年4月23日提交的共同待批的专利申请No.09/298,524的继续申请，该申请是1998年4月23日提交的共同待批的专利申请No.19/065,816的继续申请。
技术领域
本发明总的涉及一种用于椎间盘复位的脊柱植入物；更具体地说，涉及一种通过骨头向内生长使相邻脊椎融合的铰接植入物，从而恢复适当的椎间空隙，并且在保持脊柱的柔性的同时消除神经根和/或脊髓的压力。
背景技术
脊柱由多个脊椎构成，脊椎在通常状态下被软骨质的椎间盘彼此隔开。这些盘形成相邻脊椎之间的缓冲，以抵抗沿脊柱的支承轴线的压力，但允许在脊椎之间有限制地运动以提供健康脊骨的柔性特征。受伤、疾病或其它退化性紊乱会导致一个或多个椎间盘收缩、萎陷、恶化或者变得移位、突出或损伤。这会导致相邻的神经根或脊髓受压而引起慢性且经常的疼痛，并且在预先情况下引起上和/或下肢的单向瘫痪。
已经提出了许多用来使损伤或脱位的椎间盘复位的装置和方法。一种普通的方法是永久性地稳定或“融合”相邻脊椎以保持适当的椎间空隙，并且消除脊椎之间的相对运动。已经形成了多种使脊椎稳定的方法。例如，已经将骨头的榫形部分的自然发生的移植植入到脊椎之间，以使骨头生长横过椎间空隙，藉此使相邻的脊椎融合成一大块骨头。该过程的缺点是需要从病人身体的其它部分获得用于移植的供给骨，通常需要一次分离手术过程并且导致复杂化和费用的增加。另一来源是尸体的骨头，这种骨头具有潜在的传送疾病、损伤移植结合、萎陷或移位的复杂化。又一种形成脊椎稳定性的方法包括在相邻的脊椎之间植入穿孔的圆柱形骨篮(bonebasket)。将用于移植的脊椎在修整时产生的骨碎片插入骨篮，促使骨头长入、通过以及在该篮周围生长。
已经成功地证明相邻脊椎的融合可使脊椎稳定并且永久性地保持在椎间空隙中，但已经发现存在许多缺点。相邻脊椎的融合必须消除一部分脊骨的正常运动范围，因而使病人的脊柱柔度减少。另外，脊椎的融合使强加在脊柱的相邻运动部分上的应力增加，随后通常使已融合的脊椎上方和下方的正常接合面被破坏。
还提出了使用修补物来更换损伤的椎间盘，该修补物使所述椎间盘“结合”以允许脊椎之间的相对运动。已经发现这种先前所知的装置通常会有修补物与脊椎之间固连不充分的问题存在。先前所知的已结合的修补物的组件之间的预定运动会导致修补物与相邻骨表面之间的相对运动。由于该种运动会破坏骨头向内生长，因此通常认为已结合的修补物与向内生长的骨头的附连不相容。另外，由于这些装置的结合元件通常必须占用一基本垂直的宽度以达到运动的所需范围，而且必须装配在椎间空隙内，因此与脊椎的固定点一样，通常使用设置在结合元件的任何一侧上的平板或表面来附连该种装置。通过加压或摩擦配合、尖钉突出物、螺钉或销来实现该附连，在某些情况下使用向内生长入多孔表面的组织作为补充。然而，这些附连机构缺乏理想的固定程度和强度。此外，几个该种装置具有用来附连装置的附连凸缘，该附连凸缘延伸过脊椎表面。已经发现一些不理想之处，如延伸凸缘会妨碍或损伤相邻的组织。例如，已有报告说凸缘延伸入紧密相邻的、易损伤的食道区域会妨碍吞咽和说话，或者导致穿孔或潜在的致命感染。使用螺钉和销连接的另一缺陷是用于该种连接件的移位和导致损伤的可能性。
因而，可以看到仍然需要一种脊椎植入物，该脊柱植入物可有效地永久保持椎间空隙，以便在尽可能地保持受影响的脊椎之间的运动的自然范围的同时防止神经或脊髓受压。还需要一种装置，该装置可以与脊椎永久、牢固地附连，但不突伸过被附连的外表面。又需要一种用于更换受损伤或移位的盘的方法，该方法在保持脊椎之间的自然相对运动的同时保持椎间空隙以防止神经和脊髓受压。本发明的主要目的是提供满足这些和其它需要的装置和方法。
发明内容
简而言之，在一较佳形式中，本发明包括一脊柱植入物，它包括一第一元件，该第一元件具有用于接触一第一脊椎的第一连接装置。第一连接装置包括一第一融合室，该第一融合室在其中具有至少一个开口，便于骨头生长入第一融合室以使第一元件与第一脊椎融合。植入物还包括一第二元件，该第二元件具有用于接触一第二脊椎的第二连接装置。第二连接装置包括一第二融合室，该第二融合室在其中具有至少一个开口，便于骨头生长入第二融合室以使第二元件与第二脊椎融合。植入物还包括内部铰接装置，该装置使第一元件与第二元件连接，以允许第一元件与第二元件之间相对运动。术语“内部铰接装置”的意思是允许装置的组件之间相对运动的装置，而不是装置与诸如相邻骨头或其它组织的外部结构之间的装置。
在本发明的特定实施例中，第一和第二元件可具有半预制形或半椭圆形的外表面。第一和第二元件各自具有：其中穿有一个或多个开口的外壁以使骨头向内生长入融合室，以及具有若干形成内部铰接装置的、邻接的结合面。在又一较佳实施例中，结合表面构成接触的凹面和凸面，以形成一球与穴型接头(或槽与通道或其它所述接头)，该接头允许脊椎之间的相对枢转运动，但抵抗其间的加压。
第一和第二元件可以结合以形成一单个元件，可以使用与下面的先前所知的非铰接脊椎融合植入物的移植类似的方法来移植该元件。在所述临时装置生物降解分离以使第一与第二元件之间铰接之后，通过插入可生物吸收的元件以允许移植，以使临时性的稳定装置可用于第一和第二元件的刚性连接，在最初稳定的时期中，可使骨头向内生长入融合室并且使第一与第二元件与相邻的骨头融合。
本发明可以进一步地叙述成包括一脊柱植入物，该脊柱植入物具有：一第一铰接面；一第二铰接面，该第二铰接面沿大致与脊柱平行的支承轴线与第一铰接面的至少一部分接触；第一连接装置，该第一连接装置用于使第一铰接面与一第一脊椎相连；以及第二连接装置，该第二连接装置用于使第二铰接面与一第二脊椎相连。第一和第二铰接面抵抗沿支承轴线方向的第一与第二元件之间的轴向压力、但允许第一与第二元件之间的相对枢转运动。第一连接装置和第二连接装置中的至少一个(最好是两个)包括一融合室，该融合室在其中具有至少一个便于骨头向内生长的开口，藉此永久且牢固地将植入物固定就位。
在又一较佳形式中，本发明包括一种保持一第一脊椎与一第二脊椎之间的椎间空隙的方法。该方法包括以下步骤：去除第一脊椎的一部分，以便在其中形成一空腔；将脊柱植入物的一第一元件安装在第一脊椎中形成的空腔内；以及将脊柱植入物的一第二元件连接于第二脊椎。第一元件包括一第一铰接面和一第一融合室，该第一融合室在其中具有至少一个便于骨头从第一脊椎处向内生长的开口。第二元件包括一第二铰接面，其中，连接第一和第二铰接面，以形成允许第一与第二元件之间的相对枢转运动、但防止第一与第二元件之间的相对受压的一接头。在又一较佳实施例中，该方法还可包括去除第二脊椎的一部分以便在其中形成用于容纳第二元件的一空腔。第二元件还可包括便于骨头从第二脊椎处向内生长的一第二融合室。去除脊椎部分所形成的骨碎片适合移植或者可将骨头生长的刺激化合物或装置插入融合室以增强骨头向内生长。
参照下面的详细叙述、结合所附的附图进行阅读将更容易地理解本发明的这些和其它目的、特征和优点。
附图说明
图1示出了本发明的一圆柱体形状的脊柱植入物的立体图；
图2示出了图1的脊柱植入物的横剖侧视图；
图3示出了图1的脊柱植入物的横剖端视图；
图4a示出了本发明的圆柱形脊柱植入物在其位置处的端视图；
图4b示出了本发明的圆柱形脊柱植入物在其位置处的侧视图；
图5是本发明的又一实施例的横剖端视图；
图6a示出了本发明的椭圆形脊柱植入物的横剖端视图；
图6b示出了本发明的另一椭圆形脊柱植入物的横剖端视图；
图7示出了锥形脊柱植入物的横剖端视图；
图8示出了具有一摇杆和通道铰接装置的脊柱植入物的横剖端视图；
图9示出了具有一摇杆和沙漏通道铰接装置的脊柱植入物的横剖端视图；
图10a和10b示出了具有一摇杆和另一沙漏通道铰接装置的脊柱植入物的立体图；
图11a和11b示出了具有一摇杆和另一沙漏通道铰接装置的脊柱植入物的立体图；
图12是本发明的椭圆形脊柱植入物在其位置处的端视图；
图13是本发明的锥形脊柱植入物在其位置处的侧视图；
图14示出了用于在脊柱的脊椎之间切割椭圆截面的手术仪器；
图15a和15b示出了具有另一菱形通道以及相应的菱形摇杆铰接装置的脊柱植入物的立体图。
具体实施方式
现在请详细参见附图，图中相同的标号始终代表相同的部件，现在将叙述本发明的较佳型式。在图1-3中可以看到，本发明的一实施例包括一脊柱植入物10，该脊柱植入物总地包括一第一元件20和一第二元件22。用一内部铰接装置24将第一元件20连接于第二元件22，以使第一与第二元件之间相对地枢转运动。
图4A和4B示出了本发明的脊柱植入物10，该植入物就地安装在一第一脊椎12与一第二脊椎14之间。将图示的植入物10植入脊椎体的前方、第五颈椎骨与第六颈椎骨之间。然而，本发明的装置和方法可适用于接近脊椎的前方、侧向和后方。
在图2-3中可以很好地看到，植入物10的第一元件20包括第一连接装置，该第一连接装置以第一融合室30的形式用来接触第一脊椎12。第一融合室30中形成至少一开口32，便于骨头从第一脊椎12处生长入、通过以及在第一融合室30的周围生长，以使第一元件融合于第一脊椎12。最好设置多个开口32以便进一步地促进骨头向内生长。与其它已知的连接装置相比，已经发现骨头向内生长形成的融合可以在植入物10与骨骼结构之间提供更持久的刚性连接。
植入物10的第二元件22包括用于接触第二脊椎14的一第二连接装置。第二连接装置最好包括一第二融合室34，该融合室的构造基本上与上述第一融合室30相似，并且包括至少一个形成于其中的开口36，便于骨头从第二脊椎14处长入、通过以及在第二融合室34的周围生长。或者，第二连接装置可以包括一粘合连接、螺钉连接、销连接或任何其它有效的、可代替的连接装置。然而，第二融合室30的规定是较佳的，因为它与其它已知的附连装置相比提供了更持久且牢固的连接。尽管附图中描述的第一元件20和第一脊椎12与上面的第二元件22和第二脊椎14相同，但应予理解的是，本发明可以等同地理解为倒置构造，其中本文所述的第一元件附连于第一脊椎的第一元件在脊柱上的高度低于附连于第二元件的第二脊椎。第一和第二元件可由生物相容的材料制成，所述材料包括但不限于钛、手术用合金、不锈钢、铬钼合金、钴铬合金、锆氧化陶瓷、不能吸收的聚合体以及其它预先考虑的生物相容的金属或聚合物材料。
现在请参见图2-3，本发明的铰接装置24最好包括：设置在第一元件20上的一第一铰接面40，以及设置在第二元件22上的一邻接的第二铰接面42。第一和第二铰接面40、42最好由低摩擦、磨损和抗冲击、生物相容的材料制成或涂覆有该种材料，例如：钛、不锈钢、手术用合金、铬钼合金、钴铬合金、锆氧化陶瓷、不能吸收的聚合体以及其它生物相容的金属或聚合物材料。铰接装置24抵抗第一与第二元件20、22之间的轴向压力，但允许在其间相对地枢转运动。因而，如图4所示，在移植时，铰接装置24抵抗沿着大致沿图示的脊柱(例如在图4中)的支承轴线44在第一与第二脊椎12、14之间延伸的轴向压力，但允许脊椎之间的枢转运动。可将术语“枢转”理解成围绕支承轴线44(例如通过使头部向右或向左旋转以便在颈椎骨之间旋转)的旋转或扭转运动和/或沿任何相对于支承轴线44的方向成角度倾斜的倾斜运动(例如，向前或向后地点头和/或使向下的头部向右或左倾斜)中的一种运动或两者兼有。
为第一内部铰接面40设置一空隙(例如一凹面46)，该空隙可容纳从第二内部铰接表面42处突起的一隆起(例如一凸面48)，以便在第一与第二脊椎12、14之间抵抗轴向压力以及垂直于支承轴线44的侧向移动。这种“球与穴(ball-and-socket)”设置可围绕第一与第二脊椎12、14之间的支承轴线44相对旋转。铰接装置24可设有一个或多个止动件，以限制旋转运动允许的范围。
除了用于铰接装置24的“球与穴”设置以外，其它构造也是可行的。在另一实施例中，如图8和10所示，铰接装置包括摇杆100和通道101。第二铰接面42可以包括一基本上呈U形的通道101，该通道沿第二元件22的长度延伸。第一铰接面40包括一相应形状的摇杆100，例如，该摇杆可以是沿第一元件20的长度的半椭圆形。该种设置在一平面上只允许一种倾斜运动。在另一种该实施例中，如图9所示，通过修改通道102的形状可将运动的第二范围加入铰接装置24。例如，修改后的通道102的形状大致为穿过通道102的深度的沙漏状。通道基部103和嘴部104处的通道宽度大于中点105处的通道宽度。沙漏形的通道102允许沿两个垂直线性平面倾斜运动。
在第二种可替代的实施例中，如图11a和11b所示，通过修改通道106的形状可将运动的第二种可替代的范围加入铰接装置24。例如，修改后的通道106的形状大致为通过第二元件22的长度的沙漏状。通道的纵向中点107处的通道宽度小于通道的前端108和尾端109处的通道宽度。具有直接揭示的益处的本技术领域中的熟练人士将理解的是，本文所述的“沙漏”状包括多种曲线或直线边缘，只要通道的端点处或附近的宽度(或通道的顶部和底部)宽于端点之间的某些点处的宽度即可。沙漏状通道106允许两种运动范围、倾斜运动以及围绕中心轴线的枢转运动。这些运动对于某些病人是十分理想的。
在第三种可替代的实施例中，如图15a和15b所示，通过修改通道110的形状可将运动的第三种可替代的范围加入铰接装置24。例如，修改后的通道110的形状大致为通过第二元件22的长度的菱形。通道的纵向中点111处的通道宽度大于通道的前端112和尾端113处的通道宽度。另外，第一铰接表面40包括一相应形状的摇杆113，例如该摇杆可以是沿第一元件20的长度的菱形。本技术领域中的熟练人才会从本揭示中得益，他们会理解到：本文所述的“菱形”包括多种曲线或直线边缘，只要通道的端点之间的某些点处的宽度(或通道的顶部和底部)宽于端点处或附近的宽度即可。菱形通道110允许三种运动范围、倾斜运动以及围绕中心轴线的枢转运动。这些运动对于某些病人是十分理想的。
铰接装置24最好还包括一个或多个角偏移斜面50，所述斜面形成在第一内部铰接面40和/或第二内部铰接面42，以便沿一个或多个方向在第一与第二脊椎12、14之间相对倾斜运动。根据附图所示的实施例，如图9较佳地所示，在一大致呈锥形的构造中，第一和第二内部铰接面40、42各自设有一角偏移斜面50，藉此可以沿所有方向(360°)倾斜运动。一大致呈圆锥形的构造也是可行的，并且同样允许旋转运动和360°的倾斜运动。另外，如图10和11所示，第一和第二铰接面40、42可以各自提供一大致呈弧形的构造，该构造提供范围更大的运动。
在第一和第二铰接面40、42的每一周缘附近设置约5°的斜面50，以便估计脊骨运动的自然范围，因而允许沿相邻脊椎之间的所有方向有约10°的倾斜。如图所示，铰接装置24的枢转点或轴线大致位于第一和第二铰接表面40、42的中间，并且如图4所示，在插入时对准脊柱的垂直旋转轴线。然而，可以有选择地变化该位置，以使铰接装置24的旋转中心定位在脊柱的垂直旋转轴线的中间、前方、后方、左面、右面或偏心(沿前/后和左/右的方向偏心)，实现脊柱的正确对准，藉此恢复最佳的矢状和冠状脊柱的平衡和对准。
在图1较好所示的一实施例中，本发明的植入物10的第一和第二元件20、22最好包括邻接的、大致呈半圆柱形的外壁60、70，以形成大致呈圆柱形的本体。如上所述，在它们的装配构造中，第一元件20和第二元件22彼此邻接，其对应的第一和第二铰接表面40、42彼此相邻并接触。第一元件20最好包括一第一辐射式的外壁60。一个或多个便于骨头向内生长的开口32设置在该第一辐射式外壁60中，并且与第一辐射式外壁60和第一铰接面40之间形成的一第一融合室62连通。类似地，第二元件22最好包括一第二辐射式外壁70，该外壁限定一个或多个便于骨头向内生长的开口36。开口36与第二辐射式外壁70和第二铰接面34之间形成的一第二融合室72连通。第一和第二辐射式外壁60、70可以设置螺纹80，以便在移植期间将植入物10前推入椎间空隙，并且一旦在植入以后，协助植入物10固定就位。每一第一和第二辐射式外壁60、70上的螺纹80最好对准，以便在第一和第二元件20、22接触时形成连续的螺纹。在某些情况下，如同授予Kuslich等人的美国专利No.5,489,308所述的那样，最好提供自攻螺纹80和/或将螺纹80构造成引导植入开口32产生的骨碎片。在其它并非较佳的实施例中，可以用具有轮廓的外表面来替换螺纹80，所述轮廓包括平滑的、带键的、有凸缘的、尖钉状或珠状表面的特征。植入物10还可以包括一个或多个在第一和/或第二元件20、22中的支承凸缘85，所述支承凸缘可用来辅助加强。
在图6a、6b和12较好示出的第二实施例中，本发明的植入物10的第一和第二元件20、22最好包括邻接的、大致呈半椭圆形的外壁97、99，以形成大致呈椭圆形的本体。如上所述，在它们的装配构造中，第一元件20和第二元件22彼此邻接，其对应的第一和第二铰接面40、42彼此相邻并接触。第一元件20最好还包括一第一辐射式外壁97。一个或多个便于骨头向内生长的开口32设置在该第一辐射式外壁97中，并且与第一辐射式外壁97和第一铰接面40之间形成的一第一融合室62连通。类似地，第二元件最好包括一第二辐射式外壁99，该外壁限定一个或多个便于骨头向内生长的开口36。开口36与第二辐射式外壁99和第二铰接面42之间形成的一第二融合室72连通。在可替代的实施例中，第一和第二元件20、22的带轮廓的外表面可以包括平滑的、带键的、有凸缘的、尖钉状或珠状表面的特征，以便一旦在植入以后，将元件固定就位。植入物10还可以包括一个或多个在第一和/或第二元件20、22中的支承凸缘85，所述支承凸缘可用来辅助加强。
在一又一实施例中，如图7和12所示，元件10沿水平轴线倾斜。尾端92具有一垂直半径，该半径大于前端93的垂直半径。锥形形状使需要去除的材料数量减少，并且使植入物10插在第一与第二脊椎之间的方便程度增加。
在又一较佳实施例中，本发明还包括一个或多个稳定装置的设施，所述稳定装置用于临时连接第一元件20与第二元件22，以防止其间的相对运动。例如，在将植入物10安装入椎间空隙的过程中，最好将第一和第二元件20、22刚性地保持就位。另外，第一和第二元件20、22应当在植入后的充分长的时间之内保持刚性连接，以使骨头充分地向内生长入融合室，从而在病人的正常活动期间防止植入物10与脊椎12、14之间的相对运动。一般而言，在将第一和第二元件20、22分开并且彼此相对铰接之前，让骨头向内生长约八至二十周是相当充分的。使用由可生物吸收的材料构成的中等期限(medium-term)的稳定装置，本发明可以实现第一和第二元件的临时稳定，而且不需要第二次手术过程。可生物吸收的材料的示例包括聚葡萄酸盐聚合物或类似物、丙交酯、聚二烷酮、聚羟乙酸盐、丙交酯/乙交酯共聚物。适当地选择构造的材料可以有效地控制稳定装置的生物递降分解所需的时间长度。在稳定装置被人体溶解并吸收之后，分开植入物10的第一和第二元件以使其铰接。在一个示例的实施例中，如图3所示，稳定装置可以包括一个或多个生物递降分解的填隙片82，所述填隙片楔合在第一元件20与第二元件22之间，以防止其间的相对运动。在又一示例的实施例中，将第一和第二元件20、22放置成其连接构造，如图2-3所示，然后将一可生物降解分离的聚合物插入或填满铰接面40与42之间的空间，该聚合物设有中等期限的临时稳定装置以使诸元件连接就位。注意避免将聚合物填满融合室30、34和通向融合室的开口32、36。螺纹82还将保持外露以协助装置的移植。在又一示例的实施例中，如图2所示，稳定装置包括一可拆卸和/或可生物吸收的端盖90，该端盖可释放地与植入物10的尾端92接触，以连接第一与第二元件20、22。端盖可以包括：一个或多个用于接触植入物10的夹具94，以及一条或多条用于接触扳手、驱动装置或其它致动装置键槽96，所述扳手、驱动装置或其它致动装置可用于将植入物10前推入椎间空隙。可以将一第二可拆卸和/或可吸收的端盖安装在植入物10的前端93上。如同下面更详细的叙述那样，端盖的另外作用是将骨碎片保持在融合室30、34的腔室62、72内，直至骨头充分地向内生长并且发生融合。
图5描述了本发明的又一实施例，该图示出了一植入物10，该植入物总地包括基本如上所述的第一和第二元件20、22，并且还包括一中间铰接元件，该中间铰接元件在所述实施例中包括一大致呈半球形的碗状盖子90，该盖子插在第一元件20的凹面46和第二元件22的凸面48之间。盖子90最好是由抗磨损、低摩擦的材料制成的结构，它略微具有弹性以吸收冲击负荷。盖子90的规定可使盖子的顶面与第一元件20的凹面46之间和盖子的底面与第二元件22的凸面48之间的界面铰接，形成一双极铰接。该设置通过将磨损分布在两铰接界面之上以减少铰接面上的摩擦磨损。盖子90的凹入的底面与第二元件22的凸面48的啮合以及盖子90的凸出的顶面与第一元件20的凹面46的啮合可以在安装植入物10时防止盖子90被移出。
本发明还包括保持第一脊椎12与第二脊椎14之间所需的椎间空隙的方法。该方法最好包括去除第一脊椎的一部分以便在其中形成一腔室、将铰接的脊柱植入物的一第一元件安装入腔室以及将植入物的一第二元件与第二脊椎连接。用于执行该方法的铰接脊柱植入物最好与上述示例的实施例大致类似，该植入物具有第一和第二内部铰接面，邻接所述内部铰接面以形成允许第一与第二元件之间的相对枢转运动、但防止其间的相对轴向压力的一接头。最好至少一个元件还包括一融合室，该融合室包括一腔室和至少一个与该腔室连通的开口，便于骨头从相应的脊椎处生长入、通过以及在融合室的周围生长。在一较佳形式中，本发明的方法包括使用用于骨头向内生长的腔室使植入物的第一和第二元件与相应的脊椎附连。在该实施例中，最好去除第二脊椎的一部分以便在其中形成用于容纳植入物的第二元件的一腔室。本发明的方法还包括将骨碎片插入植入物的融合室，所述骨碎片可以是上述脊椎去除部分形成的碎片。所示的这些骨碎片的存在将刺激并且增强骨头向内生长入融合室。在又一实施例中，本发明的方法预料到用于刺激骨头长入、通过和/或在融合室的周围生长的装置的应用。用于刺激骨头生长的装置可以包括诸如电气或磁性骨生长激励器、骨形态发生型蛋白质(BMP)、羟基磷灰石化合物、去除矿物质的骨化合物和/或骨生长刺激装置或化合物。还预料到将通常称为手术胶水的氰基丙烯酸酯引入到融合室的外表面上，它可用来将植入物固定于最佳位置以等待骨头生长。
除了本文阐述的以外，可以使用先前所知的、大致与用来移植非铰接的刚性融合植入物的方法类似的方式来移植本发明的铰接脊柱植入物。例如，本发明的方法可以使用从用于颈部和胸部的脊柱节的前方路径或者从用于腰部脊柱节的前方或后方的侧向路径通向脊柱的标准手术路径。钻或削一大致呈圆形的孔以实现脊椎部分的去除，该孔的直径和深度适合与待使用的植入物大致配合，并且桥接第一和第二脊椎。另外，可使圆孔具有锥度，并使其前端的直径小于尾端的直径。该孔的中心最好设定在椎间空隙的上方、大约在第一与第二脊椎之间的中间。然后将在孔内攻出螺纹以便插入植入物。
在另一方法中，使用一种独特的手术仪器来实现脊椎部分的去除，如图14所示，该仪器用于钻一椭圆形的孔，该孔的大、小直径和深度适合与待使用的植入物大致配合，并且桥接第一和第二脊椎。最好将手术仪器固定于钻头，以便向切割部分提供旋转的能量。手术仪器的切割部分由椭圆形的切割刀片内的圆形开槽钻头护套构成。开槽钻头向外延伸出切割刀片以便在第一与第二脊椎之间切割一圆形部分。当钻头切入脊椎时，然后切割刀片去除剩余的材料以形成一椭圆形孔，该孔的大、小直径和深度适合与待使用的植入物大致配合，桥接第一与第二脊椎。
或者，植入物可以设有自攻螺纹。将植入物与接触的第一和第二铰接面装配，使用基本如上所述的稳定装置使植入物的第一和第二元件刚性连接。稳定的植入物进入到孔的理想深度。最好前推植入物，直至尾端92与脊椎的外表面相平齐或相对于该表面略微凹入，藉此消除植入物的向外突起部分妨碍或损伤相邻或区域内的血管、神经或内脏结构。
在需要较大承载力的腰部区域中，可将两个铰接的植入物放置成平行的位置，而且每一彼此相邻的纵向轴线呈大致平行的设置，以使弯曲/延伸运动单独进行。该设置通常需要去除脊椎材料以形成两个开口或一延伸的开口，以使两植入物相连通。或者，可以使用横过腹部的敞开的手术路径、横过腹部的腹腔镜路径或者腹膜后的敞开的前部路径将单个具有适当尺寸的植入物放置在空隙中，以便进行围绕如上所述的用于颈部或胸部的椎间盘空隙的单个铰接点的枢转运动。
骨头在手术以后将向内生长，使植入物的第一和/或第二元件与相应的脊椎融合。在经过充分的时间以后，稳定装置溶化并吸收入人体，分开铰接装置以允许第一与第二元件之间的相对运动，从而保持脊柱的柔性并且使相邻的椎间关节上的破坏性应力最小。植入物抵抗第一与第二元件之间的轴向压力，藉此防止第一与第二脊椎之间的相对压力，从而保持所需的椎间空隙。此外，将植入物压入接受者的脊椎位置，消除在下一相邻血管、神经或内脏结构上的冲击。
尽管本发明已以其较佳形式进行了揭示，但本技术领域中的熟练人士应当清楚的是，可以在不违背所附的权利要求书中阐述的本发明及其等价物的精神和范围的情况下对本发明进行多种修改、增添和删除。

Claims (26)

1.一种脊柱植入物，它包括：
(a)一第一元件，所述第一元件包括一第一铰接面、一第一外表面以及用来与一第一脊椎接触的一第一连接装置；
(b)一第二元件，所述第二元件包括一第二铰接面、一第二外表面以及用来与一第二脊椎接触的一第二连接装置；
(c)一尾壁和一前壁；以及
(d)一铰接装置，所述铰接装置使所述第一铰接面与所述第二铰接面连接，以允许所述第一元件与所述第二元件之间的相对运动，其中，所述铰接装置抵抗沿所述支承轴线方向的轴向压力。
2.如权利要求1所述的脊柱植入物，其特征在于，所述第一铰接面邻接于所述第二铰接面，以形成所述铰接装置。
3.如权利要求2所述的脊柱植入物，其特征在于，所述铰接装置包括在所述第一元件中的一凹面以及所述第二元件中的一凸面，其中所述凸面的至少一部分与所述凹面接触。
4.如权利要求2所述的脊柱植入物，其特征在于，所述铰接装置包括沿所述第二元件长度的一通道以及沿所述第一元件长度的一摇杆，其中所述摇杆的至少一部分与所述通道接触。
5.如权利要求4所述的脊柱植入物，其特征在于，沿所述第二元件长度的所述通道在所述通道的顶部和底部处的宽度大于在所述顶部与所述底部之间的某些点处的宽度。
6.如权利要求4所述的脊柱植入物，其特征在于，沿所述第二元件长度的所述通道在每一端部处的通道宽度大于每一端部之间的某些点处的通道宽度。
7.如权利要求4所述的脊柱植入物，其特征在于，沿所述第二元件长度的所述通道在每一端部处的通道宽度小于每一端部之间的某些点处的通道宽度。
8.如权利要求7所述的脊柱植入物，其特征在于，沿所述第一元件长度的所述摇杆在每一端部处的摇杆宽度小于每一端部之间的某些点处的摇杆宽度。
9.如权利要求1所述的脊柱植入物，其特征在于，所述第一连接装置包括一第一融合室，所述第一融合室位于所述第一铰接面与所述第一外表面之间，而所述第一外表面包括至少一个便于骨头向内生长入所述第一融合室的开口。
10.如权利要求1所述的脊柱植入物，其特征在于，所述第二连接装置包括一第二融合室，所述第二融合室位于所述第二铰接面与所述第二外表面之间，而所述第二外表面包括至少一个便于骨头向内生长入所述第二融合室的开口。
11.如权利要求1所述的脊柱植入物，其特征在于，所述第一外表面包括一第一辐射式外壁，而所述第二外表面包括一第二辐射式外壁。
12.如权利要求11所述的脊柱植入物，其特征在于，所述第一辐射式外壁和所述第二辐射式外壁包括一固定装置，所述固定装置用于将所述脊柱植入物固定在所述第一脊椎与所述第二脊椎之间的空腔内。
13.如权利要求12所述的脊椎植入物，其特征在于，所述固定装置包括在所述第一和第二辐射式外表面上的一螺纹表面。
14.如权利要求11所述的脊柱植入物，其特征在于，所述第一辐射式外壁和所述第二辐射式外壁包括一半圆柱形外表面。
15.如权利要求11所述的脊柱植入物，其特征在于，所述第一辐射式外壁和所述第二辐射式外壁包括一半椭圆形外表面。
16.如权利要求1所述的脊柱植入物，其特征在于，所述尾壁的一第一垂直半径大于所述端壁的一第二垂直半径。
17.如权利要求1所述的脊柱植入物，其特征在于，它还包括一稳定装置，所述稳定装置用于使所述第一元件与所述第二元件临时刚性连接。
18.如权利要求17所述的脊柱植入物，其特征在于，所述稳定装置包括一端盖，所述端盖适于与所述第一元件的一部分与所述第二元件的一部分可拆卸地接触。
19.如权利要求17所述的脊柱植入物，其特征在于，所述稳定装置包括至少一个可生物吸收的元件，所述元件适合在植入后进行吸收。
20.如权利要求1所述的脊柱植入物，其特征在于，所述中间铰接元件位于所述第一和第二铰接面之间。
21.如权利要求20所述的脊柱植入物，其特征在于，所述第一铰接面包括一凹面，而所述第二铰接面包括一凸面，所述中间铰接元件包括一大致呈半球状的盖子。
22.一种保持一第一脊椎与一第二脊椎之间的椎间空隙的方法，所述方法包括以下步骤：
(a)去除所述第一脊椎的一部分，以便在其中形成一空腔；
(b)将脊柱插入物的一第一元件安装在所述第一脊椎中形成的所述空腔内，所述第一元件包括一第一铰接面和一第一融合室，所述第一融合室在其中具有至少一个便于骨头向内生长的开口；
(c)将所述脊柱植入物的一第二元件连接于所述第二脊椎，所述第二元件包括一第二铰接面，其中，连接所述第一和第二铰接面，以形成允许所述第一与第二元件之间的相对枢转运动、但防止所述第一与第二元件之间的相对受压的一接头。
23.如权利要求22所述的方法，其特征在于，它包括将所述第一脊椎的所述去除部分的至少一部分插入外部融合室。
24.如权利要求23所述的方法，其特征在于，所述第二元件还包括其中具有至少一开口的一第二融合室，其中，所述方法还包括去除所述第二脊椎的一部分以便在其中形成一空腔，并且将所述脊柱植入物的所述第二元件安装在所述第二脊椎形成的所述空腔内。
25.如权利要求24所述的方法，其特征在于，所述方法还包括将用于刺激骨头生长的装置应用于每一所述第一和第二融合室。
26.如权利要求22所述的方法，其特征在于，所述方法还包括在所述第一元件安装在所述第一脊椎的空腔内之前，将所述第一元件临时性地刚性连接于所述第二元件，所述第二元件具有至少一个可生物吸收的稳定装置。
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JP2002512079A (ja) * 1998-04-23 2002-04-23 コーゼン リサーチ グループ インク． 関節結合脊椎インプラント

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* Cited by examiner, † Cited by third party
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CN101170970B (zh) * 2005-05-02 2011-08-03 活动脊柱技术有限公司 椎间盘假体
CN102217983B (zh) * 2005-05-02 2013-01-30 活动脊柱技术有限公司 椎间盘假体
CN103547237A (zh) * 2011-05-18 2014-01-29 欧利奇两合股份有限公司 假体脊椎盘
CN103547237B (zh) * 2011-05-18 2016-06-08 欧利奇两合股份有限公司 假体脊椎盘
US10098750B2 (en) 2011-05-18 2018-10-16 Ulrich Gmbh & Co. Kg Prosthetic intervertebral disk
CN105287059A (zh) * 2014-07-30 2016-02-03 上海祥尧医疗器械有限公司 椎体间融合器及其植入装置

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WO2001015638A1 (en) 2001-03-08
ES2284520T3 (es) 2007-11-16
EP1214027B1 (en) 2007-05-16
AU778600B2 (en) 2004-12-09
US6019792A (en) 2000-02-01
DE60034893T2 (de) 2008-01-24
DE60034893D1 (de) 2007-06-28
ATE362353T1 (de) 2007-06-15
US6440168B1 (en) 2002-08-27
AU6922400A (en) 2001-03-26
CN1262253C (zh) 2006-07-05
EP1214027A1 (en) 2002-06-19
CA2382572A1 (en) 2001-03-08
JP2003512090A (ja) 2003-04-02

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