CN101437469B - 可膨胀的椎间隔片及其使用方法 - Google Patents

可膨胀的椎间隔片及其使用方法 Download PDF

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CN101437469B
CN101437469B CN2007800164777A CN200780016477A CN101437469B CN 101437469 B CN101437469 B CN 101437469B CN 2007800164777 A CN2007800164777 A CN 2007800164777A CN 200780016477 A CN200780016477 A CN 200780016477A CN 101437469 B CN101437469 B CN 101437469B
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intervertebral spacers
cylinder
intervertebral
spacers
slit
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CN101437469A (zh
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E·J·艾伦
L·G·B·库帕
D·B·沃克
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Warsaw Orthopedic Inc
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Warsaw Orthopedic Inc
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Abstract

椎间隔片，其以压缩构造形式被插入到椎骨之间，且在插入后膨胀以接触邻近的椎骨。该椎间隔片包括第一元件和第二元件，所述第二元件在缩进和伸展的位置之间，相对于第一元件可移动。

Description

可膨胀的椎间隔片及其使用方法
发明背景
本申请针对于稳定椎骨的装置和方法，更具体地，针对于用于替代椎间盘、椎骨或两者结合的椎间移植物和使用方法，以分离和/或稳定脊柱。
脊柱被分成四个区域，包括颈部、胸部、腰部、骶尾部区。颈区包括被标识为C1-C7的上七块椎骨。胸区包括被确定为T1-T12的随后12块椎骨。腰区括五块椎骨L1-L5。骶尾区包括形成骶骨和尾骨的九块融合的椎骨。脊柱的椎骨以弯曲的构造排列，弯曲的构造包括颈曲、胸曲和腰骶曲。椎间盘位于椎骨之间，且允许屈曲、伸展、侧向弯曲和旋转。
许多情况可以导致椎间盘和/或椎骨的损伤。该损伤可以由多种原因产生，包括具体的事件例如外伤、退化情况、肿瘤或感染。椎间盘和椎骨的损伤可以导致疼痛、神经缺损，和/或活动度丧失。
多种操作包括替代全部或部分椎骨、全部或部分椎间盘、或两者都替代。一个或多个替代移植物可以被插入，以替代损伤的椎骨和/或椎间盘。该移植物降低了或消除了疼痛和神经缺损，且增加了运动范围。
发明概述
本申请针对于椎间隔片，其以压缩的构造被插入在椎骨之间且在插入后膨胀以接触相邻的椎骨。该椎间隔片可以包括第一元件和第二元件，第二元件在缩回和伸展位置之间相对于第一元件运动。在插入期间，第二元件可以以相对于第一元件的缩回位置被放置。可以使通向插入后手术的流体圆柱体或气体圆柱体开动，以将椎间隔片膨胀到希望的高度。椎间隔片可被用于替代椎间盘、椎骨或两者的结合。
在一个实施方式中，第一元件包括在此形成的第一圆柱体。第二元件包括第二圆柱体，所述第二圆柱体大小适合并被设定为插入到第一圆柱体内。该第一和第二圆柱体限定了膨胀房室。流体阀被提供，用于将流体引入到所述膨胀房室中，以膨胀所述椎骨隔片。下位的锁定机构在调整过的高度锁住上级元件。下位锁定机构包括缝隙，所述缝隙限定第一和第二夹具位置以及力产生元件，以将夹具力应用到所述第一和第二夹具部分。
附图说明
图1是代表性椎间隔片的透视图，该椎间隔片位于两个椎骨间的缩进的位置。
图2是代表性椎间隔片的透视图，该椎间隔片位于两个椎骨之间的伸展的位置。
图3是代表性椎间隔片的分解透视图。
图4是代表性椎间隔片的下位元件透视图。
图5是代表性椎间隔片的上位元件透视图。
图6是一个代表性椎间隔片的详图。
图7和8示例说明了插入椎间隔片的代表性方法。
发明详述
本申请涉及用于替代椎间盘、椎骨，或两者结合的移植物，以及插入移植物的方法。该移植物包括椎间隔10，其可以以压缩的构造被插入到椎体之间，如图1中所示，且随后膨胀以接触相邻的椎体，如图2所示。
图3-5说明了椎间隔片10的一个代表性实施方式。该椎间隔片10包括下位元件12和上位元件60，所述上位元件60相对于下位元件12从缩回的位置可移动到伸展的位置。如下面更详细的描述，该下位元件12包括第一圆柱体22，而该上位元件60包括第二圆柱体72，第二圆柱体72可插入到第一圆柱体22中。圆柱体22和72一同限定了膨胀方室。当流体被引入到膨胀房室中时，该上位元件60迅速远离下位元件12。而圆柱体22和72显示具有圆形的横断面，本领域技术人员将会意识到圆柱体22和72可以具有其它的形状，例如方形、矩形、椭圆形、肾形，等等。
图4示例了下位元件12的一个实施方式的细节。该下位元件12包括主体14，所述主体包括接触邻近椎体的底面15。该底面15可以是有织纹的，以紧握椎体。例如，齿纹、脊纹、或凹槽可以在底面15形成，以提高紧握能力。主体14具有椭圆形的构造，其包括中央区16和翼区18和20。圆柱体22在中央区16中形成。流体口24在中央区16中形成，以将流体引入到由圆柱体22和72形成的膨胀房室中。单向阀26(图3)放置在流体口24中，其允许流体，例如盐溶液引入到膨胀房室中，且阻止流体从膨胀房室中流出。一个或多个空腔30可以在翼区18和20中形成，以降低重量和材料的需求。
缝隙32可以在翼区18中形成。缝隙32将翼区18分别分成第一和第二夹具部分34和36，且将圆柱体22的壁和底部横断。可压缩密封件50被放置在缝隙32中，以防止流体从膨胀房室中渗漏。夹具部分34包括凹入面38。一对间隔耳40从凹入面38向外伸出，用于装配销42。销42的端部被稳固地固定在耳40中形成的开口中。可以使用固定销42的任何合适的技术。螺丝钉孔44从凹入面38向内延伸，以接受锁定螺丝钉46。螺丝钉孔44穿过缝隙32，因此该螺丝钉孔44被分成两部分44a，44b。螺丝钉孔44的44b部分是罗纹的。当锁定螺丝钉46被拧紧时，夹具部分34和36被拉在一起，引起圆柱体22的轻微收缩。如在本文随后所描述的，这种夹具排列如同锁定机构一样起作用，以在适合的高度调整已经完成时，在适当的位置紧紧地锁定上位元件60。
上位元件60，如图5中所示，包括平板62，其具有接合邻近椎体的顶面64。该顶面64可以是织纹的，以紧握椎体。例如，小的齿纹、脊纹或凹槽可以在顶面64中形成，以提高紧握的能力。顶板62被塑造成大体上对应于下位元件12的形状。顶板62包括中央区66和翼区68和70。圆柱体72从顶板62的底面延伸。圆柱体72大小适合于装进下位元件12内的圆柱体22。在一个实施方式中，圆柱体22的内部尺度和圆柱体22的外部直径大小为紧公差，以使密封在圆柱体22的内壁和圆柱体72的外表面之间形成。但是，在本领域的技术人员将意识到可以使用环形密封件，以在圆柱体22和72之间形成流体密闭封件。环形凹槽54可以在圆柱体72的外表面中形成，以放置密封件52。
可以提供机构，以防止下位元件12和上位元件60分离。在一个实施方式中，一对弹力指74从上位元件60的顶板62的底面向下延伸。该弹力指74的放大端76被构造成能在下位元件12上接合锁定翼片28。当上位元件60与下位元件12装配时，锁定指74的端部接触锁定翼片28。锁定指74的放大端76上的凸轮面78使弹力指74朝外弯曲且通过锁定翼片28。一旦放大端76通过锁定翼片28，弹力指74就返回到它们的原始位置，因此防止了上位元件60的分离。因此，弹力指74和锁定翼片28协同作用，以使上位元件60保持在适当的位置。
图6示例了防止下位元件12和上位元件60分离的可选择的方法。在这个实施方式中，向内伸出的唇80在圆柱体22的顶端形成且向外伸出的唇82在圆柱体72的底端形成。在这个实施方式中，上位元件60可以与下位元件12装配，其通过将上位元件60在冷的液体中，例如，液态氮中浸蘸以收缩上位元件60。当上位元件60收缩时，圆柱体72上的唇82将穿过圆柱体22上的唇80。而当返回到环境温度时，该上位元件60随后将膨胀到它的原始尺寸。
下位元件12和上位元件60可以由任何适宜的材料如PEEK制备。下位元件12和/或上位元件60的顶板62可以是多孔的，以允许骨的生长。嵌入的生物包衣，例如hydroxia appetite(HA)、BMP、或磷酸钙可以被用于促进骨的生长。下位和上位元件12和72的接触表面也可以是织纹的，以紧握邻近的椎体。
在使用中，上位元件60被装配到下位元件12中，且以压缩的构造，在相对于下位元件12的缩进的位置与上位元件60放置，如图1所示。该椎间隔片10，以压缩的构造，穿过套管150被插入到两个椎体之间的椎间空隙中(图1)。本领域的技术人员将意识到椎间隔片10可以替代一个或多个椎间盘/或椎体。在插入椎间隔片10之后，流体或压缩气体被引入到膨胀房室中，以使上位元件60延伸远离下位元件12，如图2所示。该上位元件60升高直到下位和上位元件12和60的接触表面与邻近的椎体接合。一旦椎间隔片10的高度调整合适，锁定螺丝钉24被拧紧，以相对于下位元件12的固定位置锁定上位元件60。拧紧锁定螺丝钉46使下位元件12的圆柱体22紧缩且夹紧圆柱体22的外表面。因此，圆柱体22本身作为夹具起作用，将下位和上位元件12，60锁定在合适的位置，甚至在流体从膨胀房室中渗漏的情况下。
图7和8示例了插入椎间隔片10的代表性插入工具100。插入工具100包括细长机架102，其具有在此形成的三个内腔106，108和110。进入到椎间空隙的入口可通过穿过插入到身体内的套管150获得。图7和8示例了套管150的远端和插入工具100。该插入工具100包括钩元件102，所述钩元件在椎间隔片10上接合销42。因为椎间隔片10前进穿过套管150，该椎间隔片10最初呈现图7中所显示的位置。当椎间隔片10从套管150的末端离开时，推杆104被用于将椎间隔片10旋转进入到合适的角度位置。
钩元件102和推杆104穿过第一空腔106。第二空腔108与锁定螺丝钉46排列。第三空腔110与流体阀26排列。在椎间隔片10被放置合适后，流体输送线可以被插入穿过空腔110且与流体阀26接合，将流体输送到膨胀房室中，以膨胀椎间隔片10。随后，工具被插入穿过中间空腔108，以拧紧锁定螺丝钉42。
上面描述的实施方式包括作为上位元件的元件60和下位元件的元件12。在另一个实施方式中，这些元件60，12的方向可以是互换的，元件60作为下位元件起作用而元件12作为上位元件起作用。
一个实施方式包括从后外侧方向进入脊柱。其它的申请考虑其它的途径，包括后向、前向、前侧向和测向接近脊柱，且进入脊柱的其他区域，包括脊柱的颈部、胸部、腰部、和/或骶部。
术语“远的”通常被限定为以患者的方向，或远离设备的使用者。相反，“近的”通常意味远离患者或朝向使用者。空间相对术语，例如“在下面”，“朝下”，“较低的”，“在上面”，“上部的”，等等被用于方便的描述，以解释一个元件相对于第二个元件的位置。这些术语倾向于包括该装置的不同方向，除了那些在图中描述的不同方向。而且，术语例如“第一”，“第二”等等也被用于描述多种元件、区域、部分、等等且也不意图受到限制。类似的术语指代类似元件贯穿本说明书。
如本文所用，术语“具有”、“包含”、“包括”、“含有”等等开放式词语，其指明了所陈述的元件或附图的存在，但没有排除附加的元件或附图。冠词“一个(一种)”、“一(一种)”、和“该”倾向于包括复数以及单数，除非上下文清晰地指明其他。
本发明可以在不脱离本发明的范围和本质特征下，以不同于于本文所讲述的其他具体方式进行。因此，本实施方式在所有方面被认为是示例性的，而不是限制性的，且在所附权利要求书中的含义内和同等范围内的所有变化倾向于被包括在其中。

Claims (24)

1.一种椎间隔片，其包括：
第一元件，其包括第一接触表面，以接触相邻椎体，并且包括在此形成的第一圆柱体；
第二元件，其包括第二接触表面和包括第二圆柱体，第二圆柱体可被插入到第一圆柱体内，所述第一和第二圆柱体限定膨胀房室；
阀门，用于将流体引入到所述膨胀房室内，以膨胀所述椎间隔片；
缝隙，其在与所述第一圆柱体横交的所述第一元件内形成，所述缝隙限定了在所述缝隙对立边上的第一和第二夹具部分；以及
力产生元件，以将夹具力应用到所述第一和第二夹具部分，所述夹具力穿过该第一和第二夹具部分传导到所述第一圆柱体，使所述第一圆柱体在所述第二圆柱体周围紧缩。
2.如权利要求1所述的椎间隔片，其中所述力产生元件包括螺丝钉，所述螺丝钉被拧紧以产生夹具力。
3.如权利要求2所述的椎间隔片，其进一步包括可压缩的密封件，所述密封件位于所述缝隙中以将所述流体包含在所述膨胀房室中。
4.如权利要求1所述的椎间隔片，其进一步包括锁紧机构，以防止该第一和第二圆柱体分离。
5.如权利要求4所述的椎间隔片，其中所述锁紧机构包括一个或多个弹性指，所述弹性指在该第一或第二元件之一中形成，用于将一个或多个翼片接合在另一个元件上。
6.如权利要求4所述的椎间隔片，其中所述锁紧机构包括向内伸出的元件，其在第一圆柱体的上端形成；以及向外伸出元件，其在第二圆柱体的下端形成， 并被排列为接触所述向内伸出的元件。
7.如权利要求1所述的椎间隔片，其进一步包括密封件，所述密封件位于所述第一圆柱体的内壁和所述第二圆柱体的外壁之间，以将所述的流体包含在所述膨胀房室内。
8.如权利要求1所述的椎间隔片，其进一步包括工具接合元件，用于通过插入工具进行接合。
9.如权利要求8所述的椎间隔片，其中所述工具接合元件被构造为当它在椎体间插入期间，允许所述椎间隔片旋转。
10.如权利要求9所述的椎间隔片，其中所述工具接合元件包括销，其被构造成通过钩接合在插入工具上，所述钩围绕所述销可旋转。
11.如权利要求1所述的椎间隔片，其中第一和第二元件的至少一个包括多孔的部分，以促进骨生长到椎间隔片内。
12.如权利要求1所述的椎间隔片，其中第一和第二接触表面的至少一个包括织纹，以紧握相邻的椎间体。
13.一种椎间隔片，其包括：
第一和第二元件，以接触相邻的椎体，所述第一元件具有接触一个椎体的第一接触表面，而所述第二元件具有接触另一个椎体的第二接触表面；
流体圆柱体，其被连接到所述第一和第二元件，所述流体圆柱体包括连接到所述第一元件的外圆柱体和连接到所述第二元件的内圆柱体，所述外圆柱体和所述内圆柱体限定用于容纳流体的膨胀房室；和
夹紧机构，其位于所述第一元件上，以将所述流体圆柱体锁在固定的位置，所述的夹紧机构被构造为使所述外圆柱体紧缩且夹紧所述内圆柱体，其中所述夹 紧机构包括：缝隙，其在与所述外圆柱体横交的所述第一元件内形成，所述缝隙限定了在所述缝隙对立边上的第一和第二夹具部分；以及力产生元件，以将夹具力应用到所述第一和第二夹具部分，所述夹具力穿过所述第一和第二夹具部分传导到所述外圆柱体，使所述外圆柱体在所述内圆柱体周围紧缩。
14.如权利要求13所述的椎间隔片，其中所述力产生元件包括螺丝钉，所述螺丝钉被拧紧以产生夹具力。
15.如权利要求13所述的椎间隔片，其进一步包括可压缩的密封件，所述密封件位于所述缝隙中，以将所述的流体包含在所述膨胀房室中。
16.如权利要求13所述的椎间隔片，其进一步包括锁紧机构，以防止所述内圆柱体和外圆柱体分离。
17.如权利要求16所述的椎间隔片，其中所述锁紧机构包括一个或多个弹性指，其在所述第一或第二元件之一上形成，用于将一个或多个翼片接合到另一个元件上。
18.如权利要求16所述的椎间隔片，其中所述锁紧机构包括向内伸出的元件，其在所述外圆柱体的上端形成；以及向外伸出元件，其在所述内圆柱体的下端形成，并被排列为接触所述向内伸出的元件。
19.如权利要求13所述的椎间隔片，其进一步包括密封件，所述密封件位于所述外圆柱体的内壁和所述内圆柱体的外壁之间，以将所述流体包含在所述的膨胀房室内。
20.如权利要求13所述的椎间隔片，其进一步包括工具接合元件，用于通过插入工具进行接合。 
21.如权利要求20所述的椎间隔片，其中所述工具接合元件被构造为当它在椎体间插入期间，允许所述椎间隔片旋转。
22.如权利要求21所述的椎间隔片，其中所述工具接合元件包括销，其被构造成通过钩接合到插入工具上，所述钩围绕所述销可旋转。
23.如权利要求13所述的椎间隔片，其中所述第一元件和第二元件中的至少一个包括多孔的部分，以促进骨生长到椎间隔片内。
24.如权利要求13所述的椎间隔片，其中所述第一和第二接触表面的至少一个包括织纹，以紧握邻近的椎间体。 
CN2007800164777A 2006-04-27 2007-04-04 可膨胀的椎间隔片及其使用方法 Expired - Fee Related CN101437469B (zh)

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WO2007127583A1 (en) 2007-11-08
US7998210B2 (en) 2011-08-16
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JP2009535109A (ja) 2009-10-01
JP4598871B2 (ja) 2010-12-15
US20100318189A1 (en) 2010-12-16
US8372148B2 (en) 2013-02-12
US20070255413A1 (en) 2007-11-01
ATE475376T1 (de) 2010-08-15
EP2010105B9 (en) 2010-11-03
US20110238182A1 (en) 2011-09-29
DE602007008084D1 (de) 2010-09-09
EP2010105B1 (en) 2010-07-28
EP2010105A1 (en) 2009-01-07
CN101437469A (zh) 2009-05-20
KR101289175B1 (ko) 2013-07-26
ES2348268T3 (es) 2010-12-02
US7794501B2 (en) 2010-09-14

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