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CN105055054A - 椎骨椎体间的间隔件和连接板组件 - Google Patents

椎骨椎体间的间隔件和连接板组件 Download PDF

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Publication number
CN105055054A
CN105055054A CN201510377908.9A CN201510377908A CN105055054A CN 105055054 A CN105055054 A CN 105055054A CN 201510377908 A CN201510377908 A CN 201510377908A CN 105055054 A CN105055054 A CN 105055054A
Authority
CN
China
Prior art keywords
plate portion
implant
bone
bone fixation
fixing hole
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
CN201510377908.9A
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English (en)
Other versions
CN105055054B (zh
Inventor
W·P·麦克多诺
W·L·斯特劳斯博
C·邦纳
T·佩佩
R·梅里
M·亨泽克
M·杰格
T·库恩齐
D·科赫
R·庞泽
J·里希特
R·伯杰
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.)
AO Technology AG
Synthes GmbH
Original Assignee
Synthes AG Chur
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Publication of CN105055054A publication Critical patent/CN105055054A/zh
Application granted granted Critical
Publication of CN105055054B publication Critical patent/CN105055054B/zh
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Abstract

本申请公开了一种用于插入椎骨之间的椎间盘空间中的植入体，其中，该植入体包括：间隔件部分(20)；板部分(50)，该板部分与间隔件部分连接；两个骨固定元件(70)，用于与椎骨接合；以及保持机构，用于防止骨固定元件在外科手术后从板部分退出。保持机构可以呈弹簧偏压卡扣器元件(110)的形式，该弹簧偏压卡扣器元件偏压成与骨固定元件连通，使得一旦骨固定元件前进经过卡扣器元件，卡扣器元件就偏压回它的初始位置，在该初始位置，卡扣器元件与骨固定元件相接。也可选择，保持机构可以呈推进器(310)的形式，该推进器可在第一位置和第二位置之间旋转，在该第一位置，骨固定元件可插入，在该第二位置，防止骨固定元件退出。

Description

椎骨椎体间的间隔件和连接板组件
本分案申请是基于申请号为200980150740.0(其国际申请号为PCT/US2009/063529)、申请日为2009年11月6日、发明名称为“椎骨椎体间的间隔件和连接板组件”的中国专利申请的分案申请。
相关申请的交叉引用
本申请要求美国临时专利申请No.61/112441和美国临时专利申请No.61/139920的优先权，该美国临时专利申请No.61/112441的申请日为2008年11月7日，标题为“Zero-ProfileInterbodySpacerandCoupledPlateAssembly”，该美国临时专利申请No.61/139920的申请日为2008年12月22日，标题为“ScrewandPlateLockingMechanismsforSmallerBonePlates”，这些文献的内容整个被本文参引。
背景技术
在本领域中已知包括椎体间的间隔件部分和机械连接板部分的椎间植入体用于恢复椎间盘高度、允许在相邻椎骨本体之间产生熔合和用于在愈合过程中提供稳定的固定。
希望构成一种零轮廓植入体，其中，防止将植入体固定在椎骨本体上的骨固定元件从骨和/或板中退出。
另外，希望构成一种零轮廓植入体，它包括防止植入体植入制备的椎间盘空间内太深的特征和多轴线骨固定元件连接器。螺钉退出和植入体过度插入制备的椎间盘空间中将可能对植入体的性能有不利影响。
发明内容
本发明大致涉及一种脊椎植入体。更具体地说，本发明涉及一种零轮廓椎体间的间隔件和连接的板组件，用于插入在相邻上部和下部椎骨本体之间的椎间盘空间中。优选是，植入体包括：间隔件部分；板部分，该板部分与间隔件部分连接；多个骨固定元件，用于与椎骨本体接合；以及保持机构，用于防止骨固定元件在外科手术后与植入体脱开。
在一个示例实施例中，植入体包括：第一和第二骨固定元件；间隔件部分；板部分，该板部分与间隔件部分连接；以及第一和第二弹簧偏压卡扣器元件，用于防止第一和第二骨固定元件从形成于板部分中的骨固定孔退出(例如防止外科手术后与植入体脱开)。优选是，间隔件部分包括：顶表面，用于与上部椎骨本体接触；底表面，用于与下部椎骨本体接触；第一侧表面；第二侧表面；前表面；以及后表面。
板部分包括顶表面、底表面、第一侧表面、第二侧表面、前表面、后表面、第一和第二骨固定孔以及第一和第二钻孔。第一和第二骨固定孔的尺寸设置成用于分别接收第一和第二骨固定元件。第一骨固定孔倾斜成使得第一骨固定元件与上部椎骨本体接合，而第二骨固定孔倾斜成使得第二骨固定元件与下部椎骨本体接合。第一钻孔与第一骨固定孔连通，第二钻孔与第二骨固定孔连通。
第一和第二弹簧偏压卡扣器元件分别布置在第一和第二钻孔中。第一和第二弹簧偏压卡扣器元件可从第一位置运动至第二位置。在第一位置中，第一和第二卡扣器元件的至少一部分分别突出至第一和第二骨固定孔中，使得一旦第一和第二骨固定元件分别插入第一和第二骨固定孔中，第一和第二卡扣器元件就分别至少局部覆盖第一和第二骨固定元件，以便防止退出。第一和第二弹簧偏压卡扣器元件优选是偏压向第一位置。
优选是，第一和第二骨固定元件的插入使得第一和第二骨固定元件的头部部分分别与第一和第二弹簧偏压卡扣器元件接触，以便使得第一和第二弹簧偏压卡扣器元件从它们的第一位置弹回至第二位置。然后，第一和第二骨固定元件的进一步插入使得第一和第二骨固定元件的头部部分运动至第一和第二弹簧偏压卡扣器元件的远侧，从而导致第一和第二卡扣器元件从它们的第二位置自动地运动至第一位置。
优选是，植入体还包括第一和第二止动器，以便防止植入体在植入过程中过度插入和在第一和第二骨固定元件的插入过程中帮助固定植入体的位置。优选是，第一止动器延伸至板部分的顶表面的上面，用于与上部椎骨本体接触，而第二止动器延伸至板部分的底表面的下面，用于与下部椎骨本体接触。优选是，第一和第二止动器与板部分一体形成。
在另一示例实施例中，植入体优选是包括：第一和第二骨固定元件；间隔件部分；板部分，该板部分与间隔件部分连接；以及推进器(propeller)元件，用于防止第一和第二骨固定元件从板部分退出和板部分的过度插入。间隔件部分包括：顶表面，用于与上部椎骨本体接触；底表面，用于与下部椎骨本体接触；第一侧表面；第二侧表面；前表面；以及后表面。
板部分包括顶表面、底表面、第一侧表面、第二侧表面、前表面、后表面、以及第一和第二骨固定孔。第一和第二骨固定孔的尺寸设置成用于分别接收第一和第二骨固定元件。第一骨固定孔倾斜成使得第一骨固定元件与上部椎骨本体接合，而第二骨固定孔倾斜成使得第二骨固定元件与下部椎骨本体接合。
优选是，推进器包括在第一端和第二端之间延伸的纵向轴线。推进器在第一和第二骨固定孔之间与板部分连接。在使用中，推进器可在第一位置和第二位置之间旋转，在该第一位置中，推进器并不与第一和第二骨固定孔干涉，因此第一和第二骨固定元件能够分别插入第一和第二骨固定孔中；在该第二位置中，推进器的第一端至少局部覆盖第一骨固定孔的至少一部分，推进器的第二端至少局部覆盖第二骨固定孔的至少一部分，以便一旦植入就防止第一和第二骨固定元件退出。优选是，推进器旋转通过大约90度(90°)范围从第一位置至第二位置。推进器优选是包括螺钉，用于与形成于板部分中的螺纹钻孔接合。在使用中，在第一位置，推进器的纵向轴线优选是定向成大致与植入体的轴线平行和与椎骨本体的头－尾轴线平行，使得推进器的第一端延伸至板部分的顶表面的上面，推进器的第二端延伸至板部分的底表面的下面，使得推进器在植入体的植入过程中用作止动器，以便在第一和第二骨固定元件的插入过程中防止过度插入和帮助固定植入体的位置。
在另一示例实施例中，尺寸设置成用于插入在上部和下部椎骨本体之间的椎间盘空间中的植入体包括：(a)第一和第二骨固定元件；(b)间隔件部分，该间隔件部分包括：顶表面，用于与上部椎骨本体接触；底表面，用于与下部椎骨本体接触；第一侧表面；第二侧表面；前表面；以及后表面；以及(c)板部分，该板部分与间隔件部分连接。板部分包括顶表面、底表面、第一侧表面、第二侧表面、前表面和后表面。板部分还包括第一和第二骨固定孔以及第一和第二钻孔，第一和第二骨固定孔的尺寸设置成用于分别接收第一和第二骨固定元件。第一骨固定孔倾斜成使得第一骨固定元件与上部椎骨本体接合，而第二骨固定孔倾斜成使得第二骨固定元件与下部椎骨本体接合。第一钻孔与第一骨固定孔连通，第二钻孔与第二骨固定孔连通。植入体还包括第一和第二弹簧偏压卡扣器元件，分别用于防止第一和第二骨固定元件退出。第一弹簧偏压卡扣器元件布置在第一钻孔中，第二弹簧偏压卡扣器元件布置在第二钻孔中。第一和第二弹簧偏压卡扣器元件可从第一位置运动至第二位置。在第一位置中，第一和第二卡扣器元件的至少一部分分别突伸至第一和第二骨固定孔中，使得一旦第一和第二骨固定元件分别插入第一和第二骨固定孔中，第一和第二卡扣器元件就分别至少局部覆盖第一和第二骨固定元件，以便防止退出，第一和第二弹簧偏压卡扣器元件被偏压向第一位置。
优选是，板部分的高度基本等于间隔件部分的高度，板部分的宽度优选基本等于间隔件部分的宽度。优选是，间隔件部分包括分别形成于它的第一和第二侧表面中的第一和第二凹口，板部分优选是包括从该板部分伸出的第一和第二凸起，用于与第一和第二凹口接合。
优选是，各第一和第二弹簧偏压卡扣器元件包括弹簧和卡扣器元件。优选是，卡扣器元件包括凸出至第一和第二骨固定孔中用于分别与第一和第二骨固定元件相互作用的锥形的第一端以及用于与弹簧相互作用的第二端。第一和第二弹簧偏压卡扣器元件优选是分别通过第一和第二销而分别固定在第一和第二钻孔中。
在使用中，第一和第二骨固定元件的插入优选是使得第一和第二弹簧偏压卡扣器元件从它们各自的第一位置运动至它们各自的第二位置。第一和第二骨固定元件的插入优选是使得第一和第二骨固定元件的头部部分分别与第一和第二弹簧偏压卡扣器元件接触，以便使得第一和第二弹簧偏压卡扣器元件从它们的第一位置弹回至它们的第二位置。优选是，第一和第二骨固定元件的进一步插入将使得第一和第二骨固定元件的头部部分向第一和第二弹簧偏压卡扣器元件的远侧运动，从而导致第一和第二卡扣器元件从它们的第二位置自动地运动至它们的第一位置。
优选是，植入体还包括第一和第二止动器，以便防止植入体在植入过程中过度插入以及在第一和第二骨固定元件的插入过程中帮助固定植入体的位置，第一止动器延伸至板部分的顶表面的上面，用于与上部椎骨本体接触，第二止动器延伸至板部分的底表面的下面，用于与下部椎骨本体接触。优选是，第一和第二止动器与板部分一体形成。
在另一示例实施例中，尺寸设置成用于插入在上部和下部椎骨本体之间的椎间盘空间中的植入体包括：(a)第一和第二骨固定元件；(b)间隔件部分，该间隔件部分包括：顶表面，用于与上部椎骨本体接触；底表面，用于与下部椎骨本体接触；第一侧表面；第二侧表面；前表面；以及后表面；以及(c)板部分，该板部分与间隔件部分连接。板部分包括顶表面、底表面、第一侧表面、第二侧表面、前表面、后表面、以及第一和第二骨固定孔。第一和第二骨固定孔的尺寸设置成用于分别接收第一和第二骨固定元件。第一骨固定孔倾斜成使得第一骨固定元件与上部椎骨本体接合，而第二骨固定孔倾斜成使得第二骨固定元件与下部椎骨本体接合。植入体还包括(d)推进器元件，该推进器元件有在第一端和第二端之间延伸的纵向轴线。推进器元件在第一和第二骨固定孔之间与板部分连接。推进器可在第一位置和第二位置之间旋转，在该第一位置中，推进器并不与第一和第二骨固定孔干涉，因此第一和第二骨固定元件能够分别插入第一和第二骨固定孔中；在该第二位置中，推进器的第一端至少局部覆盖第一骨固定孔的至少一部分，推进器的第二端至少局部覆盖第二骨固定孔的至少一部分，以便一旦植入就防止第一和第二骨固定元件退出。在第一位置，推进器的纵向轴线优选是定向成与植入体的轴线大致平行，使得推进器的第一端延伸至板部分的顶表面的上面，推进器的第二端延伸至板部分的底表面的下面，使得推进器在植入体的植入过程中用作止动器，以便防止植入体过度插入，并在第一和第二骨固定元件的插入过程中固定该植入体的位置。
优选是，推进器旋转通过大约90度(90°)范围从第一位置至第二位置。推进器优选是包括螺钉，用于与形成于板部分中的螺纹钻孔接合。优选是，板部分的后表面包括锥形凹口，该锥形凹口在推进器从第一位置旋转至第二位置时形成用于推进器的第一和第二端的引导斜面，使得在第二位置，推进器处于与板部分的后表面平齐。
附图说明
当结合附图阅读时将更好地理解前面的概述以及后面对本申请的优选实施例的详细说明。为了示例说明本申请的植入体，附图中表示了优选实施例。不过应当知道，本申请并不局限于所示的确切布置和工具。附图中：
图1A表示了根据本申请第一优选实施例的植入体的前向透视图；
图1B表示了图1A的植入体的侧视图；
图1C表示了图1A的植入体的俯视图；
图1D表示了图1A的植入体的前向视图；
图1E表示了图1A的植入体沿图1C的线1E－1E剖开的剖视图；
图1F表示了图1A的植入体沿图1A的线1F－1F剖开的剖视图；
图2A表示了图1A的植入体的板部分的前向透视图；
图2B表示了图2A的板部分沿图2A的线2B－2B剖开的剖视图；
图2C表示了与图1A的植入体结合使用的保持机构的放大剖视图；
图2D表示了图2C的保持机构的透视图；
图2E－2J表示了图1A中所示的植入体的多个可选视图，包括设置成在撞击(impaction)过程中至少局部嵌入椎骨本体中的止动器部件的各种可选设计；
图3A表示了用于接触和弹回图2D的保持机构的示例取出仪器的俯视平面图，以便能够从植入体中取出骨固定元件；
图3B是图3A的取出仪器沿图3A的线3B－3B的放大剖视图；
图4A表示了根据本申请第二优选实施例的植入体的前向透视图，保持机构处于第一位置；
图4B表示了图4A中所示的植入体的侧视图，保持机构处于第一位置；
图4C表示了图4A中所示的植入体的前向透视图，保持机构处于第二位置；
图4D表示了图4A中所示的植入体的侧视图，保持机构处于第二位置；
图5A表示了图4A中所示的植入体的前向透视图，该植入体插入在相邻椎骨本体之间的椎间盘空间中，保持机构处于第一位置，其中，保持机构用作止动器，防止植入体过度插入椎间盘空间中；
图5B表示了图4A中所示的植入体的前向透视图，该植入体插入在相邻椎骨本体之间的椎间盘空间中，保持机构处于第二位置；
图6A表示了图4A中所示的植入体的顶部透视图，板部分包括可选的螺纹阻挡机构；
图6B表示了图6A中所示的植入体的可选顶部透视图，表示了可选的螺纹阻挡机构与植入的骨固定元件接触；
图7A表示了与图4A的植入体结合使用的板部分的前向分解透视图，保持机构包括用于与板部分接合的第二示例连接机构；
图7B表示了图7A中所示的板部分和保持机构沿图7A的线7B－7B剖开的剖视图；
图8表示了与图4A的植入体结合使用的板部分的局部剖视图，保持机构包括用于与板部分接合的第三示例连接机构；
图9A表示了图4A中所示的植入体的前向透视图，该植入体包括第二示例间隔件部分；
图9B表示了图9A中所示的植入体的顶部透视图，其中省略了可选的多孔PEEK部分；
图9C表示了图9A中所示的植入体沿图9A中的线9C－9C剖开的剖视图，其中省略了可选的多孔PEEK部分；
图10A－10E表示了用于插入图4A的植入体的示例插入仪器和方法的多个视图；以及
图11A－11C表示了用于插入植入体的示例插入器和钻引导仪器的多个视图。
具体实施方式
下面的说明书中使用的某些术语只是为了方便，而不是限定。词语“右”、“左”、“下部”和“上部”表示所参考的图中的方向。词语“内侧”或“远侧”和“外侧”或“近侧”是指分别朝向和远离植入体和它的相关部件的几何中心的方向。词语“前面”、“后面”、“上面”、“下面”以及相关词语和/或短语是指所参考的人体的优选位置和方位，而不是进行限制。术语包括上述词语、衍生词和类似意思的词。
类似参考标号将在整个申请中用于介绍这里所述的植入体的各优选实施例的类似或相同部件，且说明书将集中在各实施例的、使得该特殊实施例与其它实施例区分的特定特征。
本申请的优选实施例涉及植入体10、200(“10－200”)。应当知道，尽管植入体10－200的各实施例将结合脊椎外科手术来介绍，但是本领域技术人员应当知道，植入体10－200以及它的部件可以用于植入身体的其它部分中，例如包括长骨或者膝盖、臀部、肩部或其它关节置换中的骨，或者用于骨量扩增。
优选是，植入体10－200的各个实施例的尺寸和形状设置成植入在相邻椎骨本体V之间。植入体10－200的尺寸和形状可以设置成替代在相邻椎骨本体V之间的全部或基本全部椎间盘空间D，或者只替代椎间盘空间D的一部分。此外，优选的植入体10－200可以设置成替代整个椎骨本体V和相关椎间盘空间D或者病人脊椎中的多个椎间盘空间D，如本领域普通技术人员根据阅读本申请可知。植入体10－200可适用于在前部、前－侧部、直接侧部、椎间孔外、经椎间孔和后部进入方法中插入脊椎内。
各优选实施例的植入体10－200包括椎体间的间隔件部分20、220、220′(“20－220”)和板部分50、250、250′、250"、250″′(“50－250”)。优选是，间隔件部分20－220的尺寸和形状设置成用于植入在相邻椎骨本体V之间的椎间盘空间D中。各优选实施例的间隔件部分20－220包括顶表面22、底表面24、第一侧表面26、第二侧表面28、前表面30和后表面32。顶表面和底表面22、24适合与相邻椎骨本体V的端板接触和用于相对于端板固定。优选是，间隔件部分20－220的尺寸和形状设置成保持和/或恢复在相邻椎骨本体V之间的所需椎间盘高度。因此，顶表面和底表面22、24可以包括一系列的齿、脊、尖头或其它类似凸起25，以便帮助将植入体10－200固定在相邻椎骨本体V的端板上。
顶表面和底表面22、24还可以包括弯曲或锥形表面，以便帮助提供用于与病人的脊椎匹配的解剖学形状，或者以所需方式来定向相邻椎骨本体V的端板。沿前－后方向的特殊表面形状和曲率、锥度或可选表面特征以及沿中间-侧部方向的特殊表面形状和曲率、锥度或可选表面特征将取决于植入体10－200将植入的位置和/或外科医生的偏好或者植入体10－200是否用于身体中的其它区域。
间隔件部分20－220还可以包括一个或多个钻孔、开口、窗口或槽道34，用于接收骨移植材料。例如，植入体10－200可以包括穿过间隔件部分20－220从顶表面22延伸至底表面24的一个或多个竖直开口、窗口或槽道，用于插入骨移植材料，以便在植入体10－200植入后促进穿过竖直开口、窗口或槽道34的骨生长。如果间隔件部分20－220由非同种异体移植物或非骨生长材料而构成(例如聚醚醚酮“PEEK”)，一个或多个钻孔、开口、窗口或槽道34将特别优选。
优选是，板部分50－250与间隔件部分20－220连接，以便在愈合过程中增加植入体的稳定性以及在植入过程中最佳地定向骨固定元件70的轨道。
各优选实施例的板部分50－250包括顶表面52、底表面54、第一侧表面56、第二侧表面58、前表面60和后表面62。板部分50－250优选是与间隔件部分20－220的后表面32接触，且优选是并不延伸超过间隔件部分20－220的竖直或横向周边或者并不大大增加间隔件部分20－220的竖直或横向周边。这样，植入体10－200具有较低轮廓。另外，这样，板部分50－250优选是整个植入在相邻椎骨本体V之间的椎间盘空间D中，以便使得板部分50－250几乎没有或者没有外部轮廓(例如，板部分50－250并不向前延伸超过椎间盘空间D的边缘)。这样，几乎没有或者没有结构凸出至椎间盘空间D的边界外部或椎骨本体V的轮廓外部，从而限制发育异常(dysphasia)和病人的不舒服。在使用中，板部分50－250的尺寸和结构可以设置成使得板部分50－250的顶表面和底表面52、54与相邻椎骨本体V的端板接触。也可选择，板部分50－250的尺寸和结构可以设置成使得只有间隔件部分20－220与相邻椎骨本体V接触。例如，板部分50－250的高度可以足够小，以便使得它在植入位置中与间隔件部分20－220连接时并不与椎骨本体V接触。
板部分50－250可以通过目前或以后知道的任意连接机构而与间隔件部分20－220连接。例如，间隔件部分20－220可以包括形成于侧表面或后表面中的一个或多个凹口36，用于与从板部分50－250伸出的一个或多个凸起64接合。优选是，间隔件部分20包括形成于它的各侧表面26、28中的凹口36，用于与从板部分50－250伸出的凸起64接合。凹口36可以完全从间隔件部分20的顶表面22延伸至底表面，或者可以只从顶表面或底表面20、22部分地伸出。用于使得板部分50－250与间隔件部分20－220连接的其它连接机构在国际专利申请No.PCT/US2008/082473中公开，该国际专利申请No.PCT/US2008/082473的申请日为2008年11月5日，标题为“LowProfileIntervertebralImplant”，该文献的内容整个被本文参引。
优选是，板部分50－250的后表面62包括用于与一个或多个插入工具接合的工具接合特征80。工具接合特征80可以为目前或以后已知用于该目的的任意形式，包括形成于板部分50－250的后表面62中的一个或多个凹口，该凹口分别从顶表面和底表面52、54伸出，用于与插入工具的臂接合。也可选择，工具接合特征80可以是形成于板部分50－250的后表面62中的螺纹孔(未示出)等，用于与从插入工具伸出的螺纹杆接合。
优选是，植入体10－200包括一个或多个骨固定孔40，用于接收一个或多个骨固定元件70，优选是骨螺钉，从而在使用中，在植入体10－200插入在相邻椎骨本体V之间的椎间盘空间D内之后，植入体10－200可以固定在相邻椎骨本体V上。优选是，骨固定元件70包括螺纹杆72和局部球形的头部部分74，该头部部分74在它与骨固定孔40接触的位置处大致平滑。螺纹杆72可以是自攻丝，即并不需要钻出导向孔，但是并不这样限制。骨固定元件70并不局限于骨螺钉70，而是可以包括螺旋钉、远侧膨胀的钉或螺钉等。优选是，骨固定孔40的尺寸和形状设置成使得骨固定元件70的头部部分74在骨固定元件70完全植入时并不向近侧凸出超过板部分50的后表面62。
优选是，骨固定孔40包括弯曲或截头球形表面，用于与骨固定元件70的头部部分74的大致平滑或截头球形表面的下侧接触，使得骨固定元件70能够相对于板部分50－250进行多轴线旋转，可以根据外科医生的偏好或需要选择多个轨道角度用于骨固定元件70，从而能够在愈合过程中调整植入体10－200。
优选是，板部分50－250包括第一和第二骨固定孔40，用于接收第一和第二骨固定元件70，其中，第一骨固定元件70向上倾斜，用于与上部椎骨本体V接合，第二骨固定元件70向下倾斜，用于与下部椎骨本体V接合。也就是，骨固定孔40优选是具有相对于植入体10－200倾斜定向的纵向轴线41，使得骨固定元件70相对于间隔件部分20的顶表面和底表面22、24形成紧固件角度，其中，骨固定角度可以在20度(20°)和60度(60°)之间的范围内，更优选是在30度(30°)和50度(50°)之间。骨固定角度可以对于所有孔40都相同，或者可以对于各孔40不同。此外，骨固定孔40可以向内朝向植入体10－200的中心，或者向外离开植入体10－200的中心，优选是以横向骨固定角度α，使得骨固定元件70朝着植入体10－200的中心平面横向向内延伸或者离开植入体10－200的中心平面横向向外延伸。横向骨固定角度α可以在正60度(60°)和负60度(-60°)之间的范围内，优选是在0度(0°)和正或负30度(30°)之间，更优选是大约正或负15度(15°)。横向骨固定角度α可以对于所有孔40都相同，或者可以对于各孔40不同。不过，本领域普通技术人员通过阅读本发明可以知道，因为骨固定元件70为多轴线，因此可以有多个可能的角度，如后面更详细所述。
不过应当知道，植入体10－200可以包括三个、四个、五个或更多的骨固定孔40，这些骨固定孔40设置成接收相应数目的、成任意数目结构的骨固定元件70。此外，从顶表面和底表面22、24伸出的骨固定元件70的数目可以变化，从顶表面22伸出的骨固定元件70的数目不需要等于从底表面24伸出的骨固定元件70的数目。
优选是，用于骨固定孔40的出口开口至少局部形成于板部分50－250的顶表面或底表面52、54中。出口开口还可以至少局部或整个形成于间隔件部分20－220的顶表面或底表面22、24中。骨固定孔40还可以包括局部球形内部容积，以便容纳骨固定元件70的头部部分74的局部球形几何形状，从而对于骨固定元件70能够选择相对于椎骨本体V的一定范围的多轴线方位。
优选是，植入体10－200还包括保持机构，用于降低骨固定元件70可能在外科手术后与植入体10－200脱开并离开椎间盘空间D的可能性。在使用中，保持机构优选是覆盖骨固定孔40和(因此)骨固定元件70的至少一部分，以便防止骨固定元件70退出，如后面更详细所述。
包括间隔件部分20－220和板部分50－250的植入体10－200可以由任意合适的可生物相容材料或材料组合来构成，这些可生物相容材料包括但不局限于：一种或多种以下金属，例如钛、钛合金、不锈钢、铝、铝合金、镁等；聚合物例如PEEK、多孔PEEK、碳纤维PEEK、可再吸收聚合物、PLLA等；同种异体移植物；合成的同种异体移植物的替代物；呈生物玻璃形式的陶瓷；钽；镍钛诺；或者可选的骨生长材料或者这些材料的一些复合材料或者组合。
间隔件部分20－220可以由与板部分50－250不同的材料来形成。例如，板部分50－250可以由金属材料例如钛或钛合金形成，间隔件部分20－220可以由非金属材料(例如聚合物如PEEK、同种异体移植物、可生物再吸收材料、陶瓷等)形成。也可选择，板部分50－250和间隔件部分20－220可以由相同材料形成。此外，板部分50－250和间隔件部分20－220可以一体形成、预先装配、或者分开地提供给外科医生并在手术室中装配。
如本领域普通技术人员可知，植入体10－200或它的部分也可以涂覆有各种化合物，以便增强骨在上面生长或骨向内生长，从而促进愈合或能够修正植入体10－200，这些化合物包括羟磷灰石、钛-镍、钛的蒸气等离子体喷射沉积、或者等离子体处理以便使得表面亲水。
参考图1A－2J，第一优选实施例的椎间植入体10包括间隔件部分20、板部分50、第一和第二骨固定元件70以及保持机构。在第一优选实施例中，保持机构呈弹簧偏压卡扣器元件110的形式。更优选是，板部分50包括与各骨固定孔40连通的钻孔112，用于接收弹簧114和卡扣器元件116。钻孔112限定了与骨固定孔40和(因此)骨固定元件70的纵向轴线41相交的纵向轴线。相交角度可以为横向、垂直或者锐角。
优选是，卡扣器116包括用于接触或与骨固定元件70的头部部分74相互作用的第一端118以及用于接收、接触或者与弹簧114相互作用的第二端120。优选是，弹簧114的尺寸和形状设置成偏压卡扣器116，以便使得一旦骨固定元件70插入骨固定孔40内，则卡扣器116凸出至骨固定孔40中和骨固定元件70的头部部分74上面，以便防止退出。优选是，弹簧偏压卡扣器116通过销或定位螺钉125而固定在钻孔112中。也就是，卡扣器116可以包括形成于其中的槽或凹口126，用于与位于钻孔125a内的销或定位螺钉125匹配。销或定位螺钉125和槽或凹口126的相互作用防止卡扣器116从钻孔112掉下。例如，卡扣器116优选是包括圆形铣削狭槽126，且销或定位螺钉125可以有螺纹，并优选是包括形状配合部，使得卡扣器116可以接收和卡在形成于卡扣器116中的狭槽126的内部。也可以使用其它机构来用于将弹簧偏压卡扣器116固定在板部分50上。
在第一优选实施例中，板部分50还包括第一和第二止动器65，其中，第一止动器65从板部分50的顶表面52向上凸出，用于与上部椎骨本体V接触，第二止动器65从板部分50的底表面54向下凸出，用于与下部椎骨本体V接触。可以设想包括更多或更少的止动器65。具有第一和第二止动器65将方便使得植入体10相对于相邻椎骨本体V充分布置，而不管病人脊椎的不规则解剖结构如何，该不规则解剖结构通常具有椎骨本体V的外表面的特征。止动器65优选是成一体地形成于板部分50上。
在使用中，止动器65设置成在植入过程中抵靠椎骨本体V的前侧，不过根据使用的外科手术处理过程和插入通路，止动器65可以抵靠椎骨本体V的侧面或前－侧面。止动器65帮助防止植入体10在植入过程中过度插入，并帮助在骨固定元件70的插入过程中固定植入体10的位置，如后面更详细所述。部分地，由于止动器65的布置，植入体10大致有至少沿头－尾中线在椎间盘空间D外部的零轮廓，这是因为板部分50的后表面62可以设计成凸形，以便与椎间盘空间D匹配。参考图2E－2J，如果需要，止动器65的远侧表面65a可以设置成在撞击过程中至少局部嵌入椎骨本体V中，以便进一步减小板部分50在椎间盘空间D外部的轮廓。例如，如图2E中所示，止动器65的远侧表面65a可以包括从它伸出的棱椎形凸起或齿66，用于在撞击过程中至少局部嵌入椎骨本体V中。也可选择，止动器65的远侧表面65a可以包括从它伸出的多个凸起或齿67(如图2F中所示)、竖直叶片形凸起68(如图2G和2H中所示)或横向叶片形凸起69(如图2I和2J中所示)，用于在撞击过程中至少局部嵌入椎骨本体V中。
在操作中，外科医生制备通向椎间盘空间D的通路或槽道，进行至少局部椎间盘切除术，并将包括间隔件部分20和板部分50的植入体10插入椎间盘空间D中，直到止动器65与相邻椎骨本体V接触。在外科医生选择了用于骨固定元件70的所需进入角度之后，外科医生在有或没有预先形成的导向孔的情况下使得第一和第二骨固定元件70以选定角度进入和通过骨固定孔40。骨固定元件70前进至骨固定孔40中将使得骨固定元件70的头部部分74与骨固定孔40的内部球形部分接触，并将椎骨本体V拉动成对齐，而不是导致植入体100过度插入，这是因为止动器65在骨固定操作的过程中引导椎骨本体V的运动。也就是，因为止动器65与相邻椎骨本体V接触和防止植入体10过度插入椎间盘空间D中，因此骨固定元件70的前进将使得相邻椎骨本体V拉拢和/或重新定位在一起，以便促进熔合。骨固定元件70前进，直到椎骨本体V最佳对齐，且骨固定元件70的头部部分74前进至骨固定孔70的球形部分中。
当骨固定元件70前进通过骨固定孔40时，骨固定元件70的头部部分74的下侧与凸出至骨固定孔40中的、卡扣器元件116的第一端118(优选是锥形端部部分117)接触，从而推压卡扣器元件116以便弹回至弹簧114上，并使得卡扣器元件116从骨固定孔40退回，使得骨固定元件70能够植入。一旦骨固定元件70的头部部分74前进经过卡扣器元件116的锥形端部部分117，弹簧114将卡扣器元件116推回至它们的初始位置，在该初始位置，卡扣器元件116至少局部凸出至骨固定孔40中。在该位置，卡扣器元件116的第一端118设计成覆盖骨固定元件70的头部部分74的顶表面的至少一部分、与骨固定元件70的头部部分74的顶表面接触和/或相互作用，以便阻挡骨固定元件70的头部部分74和限制骨固定元件70使其不会退出骨固定孔40。具体地说，卡扣器元件110的第一端118优选是伸入骨固定孔40中，使得骨固定元件70的头部部分74在不碰撞第一端118的情况下不能离开骨固定孔40。
在植入后，骨固定元件70优选是自由地肘节运动(toggle)，以便能够在外科手术后的愈合过程中进行调整。参考图3A和3B，如果外科医生确定植入体10的放置并不是最佳时，可以通过用钝器或套筒来压缩卡扣器元件116而进行调节，以便使得骨固定元件70能够取出。例如，取出仪器1000可以包括用于与骨固定元件70接合的内部轴1010以及用于接触和弹回卡扣器元件116的外部轴1020，使得骨固定元件70可以从板部分50中取出。
参考图4A－5B，第二优选实施例的椎间植入体200包括椎体间的间隔件部分220、板部分250、第一和第二骨固定元件70以及保持机构。在第二优选实施例中，保持机构呈可在第一位置(在图4A、4B和5A中所示)和第二位置(在图4C、4D和5B中所示)之间运动(更优选是旋转)的推进器310的形式。在第一位置，推进器310并不与第一和第二骨固定孔40干涉，因此第一和第二骨固定元件70能够插入相邻椎骨本体V中。在第二位置，推进器310阻挡或覆盖骨固定孔40的至少一部分，因此阻挡或覆盖植入的骨固定元件70的至少一部分，以便防止退出。
优选是，推进器310预先装配或预先附接在板部分250上。推进器310可以通过本领域目前或以后知道的任意连接机构而附接在板部分250上，所述任意连接机构包括下述内容。在第二优选实施例中，推进器310通过保持螺钉320而预先装配在板部分250上，该保持螺钉320与布置在形成于板部分250中的骨固定孔40之间的螺纹钻孔(未示出)相接。保持螺钉320可以伸入间隔件部分220内并可与该间隔件部分220螺纹连接，但是并不局限于此。也可选择，保持螺钉320可以通过附接在保持螺钉320的杆上的螺旋楔形件、十字销杆、铆钉等而相对于板部分250牢固连接。推进器310包括限定了纵向轴线的第一和第二端312、314，该纵向轴线大致横过保持螺钉320的纵向轴线。
优选是，推进器310和保持螺钉320可从第一位置旋转通过大约90度(90°)范围至第二位置。在第一位置，推进器310的纵向轴线定向成大致与植入体200的纵向轴线平行以及大致与脊椎的头－尾轴线平行，因此推进器310并不与骨固定孔40或骨固定元件70干涉，以便使得骨固定元件70能够插入相邻椎骨本体V中。在第二位置，推进器310的纵向轴线大致定向成垂直于脊椎的头－尾轴线，因此推进器310阻挡或覆盖骨固定孔40和骨固定元件70的至少一部分，以便防止退出。也就是，在第二位置，推进器310覆盖骨固定元件70的头部部分74的至少一部分，而在第一位置，推进器310允许骨固定元件70插入骨固定孔40中和插入相邻椎骨本体V中。
优选是，保持螺钉320包括用于与插入仪器500接合的接合特征321，如下面更详细所述，以便使得保持螺钉320和推进器310旋转至第一和第二位置和在该第一和第二位置之间旋转。保持螺钉320和推进器310相互连接，且优选是可通过在保持螺钉320的外径和穿过推进器310的沉孔(未示出)的直径之间的两点干涉配合而一起旋转。
优选是，板部分250包括锥形凹口330，该锥形凹口330形成引导斜面，使得在第二位置，推进器310优选是处于与板部分250的后表面62平齐(最好如图4D中所示)。因此，在第一位置(图4A和4B)，推进器310从板部分250的后表面62伸出，而在第二位置(图4C和4D)，推进器310的前方表面处于与后表面62大致平齐或者相对于后表面62稍微凹入。因此，在植入结构中，当推进器310处于第二位置时，整个植入体200(包括推进器310)都处于病人的脊椎的边界内，或者相对于椎骨V的前侧处于后面。
在操作中，外科医生制备通向椎间盘空间D的通路或槽道，进行至少局部椎间盘切除术，并在推进器310处于第一位置的情况下将包括间隔件部分220和板部分250的植入体200插入椎间盘空间D中。在第一位置，推进器310的尺寸设置成在植入体200的植入过程中用作止动器，从而防止植入体200的过度插入，以及在插入骨固定元件70的过程中固定植入体200的位置。特别是，推进器310的端部312、314与相邻的椎骨本体V接触和/或接合，从而机械地锁定植入体200向椎间盘空间D中的进一步插入(最好如图5A所示)。
当外科医生选择骨固定元件70的所需进入角度后，外科医生在有或没有预先形成的导向孔的情况下以选定的角度将第一和第二骨固定元件70推入骨固定孔40中并通过该骨固定孔40。骨固定元件70前进至骨固定孔40中将使得骨固定元件70的头部部分74与骨固定孔40的内部球形部分接触，并将椎骨本体V拉动成对齐，而不是导致植入体200过度插入，这是因为推进器310优选是在骨固定操作的过程中引导椎骨本体V的运动。骨固定元件70前进，直到椎骨本体V最佳地对齐，且骨固定元件70的头部部分74前进至骨固定孔70的球形部分中。然后，通过使得插入仪器与保持螺钉320上的仪器接合特征321匹配，保持螺钉320和推进器310由形成于板部分250的后表面62中的凹口330引导而从第一位置旋转90度(90°)至第二位置。当保持螺钉320从第一位置旋转至第二位置时，保持螺钉320优选是根据形成于它的杆上的螺纹节距而向远侧前进，且推进器310沿由凹口330形成的引导斜面而向下旋转，并当覆盖骨固定元件70的头部部分74时将位于该凹口内。由凹口330形成的引导斜面的形状优选是阻止推进器310过度旋转经过第二位置，使得推进器310的端部至少局部覆盖骨固定元件70的头部部分74。同样，通过推进器310而防止骨固定元件70从板部分250和间隔件部分220退出。
在植入后，骨固定元件70优选是自由地肘节运动，以便能够在外科手术后的愈合过程中进行调整。当外科医生确定植入体200的放置并不是最佳时，可以通过使得推进器310往回旋转至第一位置而进行调节，从而解除对骨固定元件70的头部部分74的阻挡，并能够对它进行调节。
参考图6A和6B，图中表示了用于植入体200的板部分250′的第二优选实施例。在板部分250′的第二优选实施例中，骨固定孔40包括凸出的螺纹阻挡机构350，该螺纹阻挡机构350的尺寸和形状设置成允许第一和第二骨固定元件70相对于骨固定孔40进行螺纹前进，直到形成于骨固定元件70的杆72上的最近侧螺纹73向远侧前进经过螺纹阻挡机构350为止，在该处，螺纹阻挡机构350的远侧表面与最近侧螺纹73的近侧接触，以便阻止第一和第二骨固定元件70从骨固定孔40退出。螺纹阻挡机构350可以采取升高脊或者中断的材料环的形式，或者为设置成允许骨固定元件70的最近侧螺纹73前进至将阻止沿相反方向退回的点的各种其它凸出特征。也可选择，螺纹阻挡机构350可以布置在骨固定孔40中以便阻挡骨固定元件70的头部部分74的近侧表面，而不是阻挡最近侧螺纹73。也可选择，螺纹阻挡机构350可以设置成与形成于骨固定元件70的头部部分74的侧部上的相应凹入部分(未示出)接合。
骨固定元件70还可以包括在最近侧螺纹73和头部部分74的远侧部分之间的底切部75，用于使得骨固定元件70在完全布置于骨固定孔40中之后能够大致自由地旋转，从而在植入过程中允许椎骨本体V相对于植入体200滞后(lagging)。
在操作中，植入体200定位在相邻椎骨本体V之间，骨固定元件70前进至骨固定孔40中，直到形成于骨固定元件70的杆部分72上的最近侧螺纹73前进经过凸出的螺纹阻挡机构350为止。骨固定元件70相对于板部分250′完全布置在该位置中。螺纹阻挡机构350的远侧表面与形成于骨固定元件70的杆部分72上的最近侧螺纹73的近侧接触，以便限制骨固定元件70，防止其从骨固定孔40退出。骨固定元件70在完全放置之后由于包括位于各骨固定元件70的最近侧螺纹73和头部部分74之间的底切部75而大致自由旋转，以便在植入过程中允许椎骨本体V相对于植入体200滞后。然后，推进器310可以与螺纹阻挡机构350结合使用，以便在骨固定元件270的插入过程中固定植入体200的位置，以及增加了附加的防退出。也可选择，可以设想，螺纹阻挡机构350可以包含在植入体10的第一优选实施例中。
参考图7A和7B，图中表示了用于植入体200的板部分250"的第三优选实施例。板部分250"的第三优选实施例包括用于使得推进器310"与板部分250"连接的可选连接机构。在该实施例中，推进器310"包括多个狭槽317"，这些狭槽317"从推进器310"的远端316"伸出，使得推进器310"包括多个弹簧状的指状件315"，这些指状件315"沿与推进器310"的端部312"、314"的纵向轴线大致垂直地向远侧延伸的轴线来定向。优选是，弹簧指状件315"包括在它的远端316"处的、向外伸出的凸缘318"。板部分250"优选是包括布置在骨固定孔40之间的、无螺纹的钻孔263"。该无螺纹钻孔263"优选是包括一个或多个斜面263a"和一个或多个台阶263b"，用于与弹簧指状件315"相接，以便将推进器310"固定在板部分250"上。
可选的保持夹340"(例如由例如耐蚀游丝合金形成的叉骨形夹)可以安装在钻孔263"中，以便通过允许推进器310"插入钻孔263"中同时附加防止推进器310"从钻孔263"退出而进一步帮助将推进器310"固定在板部分250"上。
在操作中，推进器310"通过将弹性指状件315"插入钻孔263"中直到推进器310"卡扣至钻孔263"内、将推进器310"保持于其中而装配在板部分250"上。也就是，当弹性指状件315"前进至钻孔263"内时，形成于推进器310"的远端316"上的锥形凸缘318"和弹性指状件315"压缩，使得指状件315"通过可选的保持夹340"，然后，弹性指状件315"局部向外弹回。当凸缘318"通过时，保持夹340"可以另外稍微向外弯曲，然后，保持夹340"弹回至它的初始结构。当弹性指状件315"继续前进至钻孔263"内时，指状件315"经过台阶263b"，随后在斜面263a"附近向外弯曲至它们的未偏转结构。这样，通过在凸缘318"和台阶263b"之间的相互作用而防止推进器310"通过钻孔263"退出。
参考图8，图中表示了用于植入体200的板部分250″′的第四优选实施例。板部分250″′的第四优选实施例包括用于使得推进器310″′与板部分250″′连接的第三可选连接机构。在该实施例中，无螺纹的钻孔263″′包括第一斜面263a″′、第一台阶263b″′、第二优选螺旋形斜面263c″′和第二台阶263d″′(当从板部分250″′的后表面62运动时)。推进器310″′的结构基本与上述第二示例连接机构的推进器310"相同。
在操作中，推进器310″′通过将弹性指状件315″′插入无螺纹钻孔263″′中直到推进器310″′卡扣在该钻孔263″′内而装配在板部分250″′上，该钻孔将推进器310″′保持于其中。当弹性指状件315″′前进至钻孔263″′中时，弹性指状件315″′在锥形凸缘318″′经过第一斜面263a″′和越过第一台阶263b″′时压缩，在经过第一台阶时，弹性指状件315″′和凸缘318″′局部向外弹出，从而将推进器310″′固定在板部分250″′上。通过在凸缘318″′和第一台阶263a″′之间的相互作用而防止推进器310″′通过钻孔263″′退出。此外，当推进器310″′从第一位置运动至第二位置时，弹性指状件315″′进一步前进至钻孔263″′内，其中，凸缘318″′由优选螺旋形成的第二斜面263c″′来引导，直到凸缘318″′通过第二台阶263d″′。弹性指状件315″′和凸缘318″′向外弯曲至它们的未偏转结构，以便通过在凸缘318″′和第二台阶263d″′之间的相互作用而防止推进器310″′通过钻孔263″′退出。
参考图9A－9C，用于椎间植入体10－200的第一和第二优选实施例(所示为第二优选实施例)的间隔件部分220′的可选实施例包括位于中心的多孔PEEK区域422，该多孔PEEK区域422由普通PEEK部分420同心环绕。
在操作中，植入体200以与前面所述类似的方式植入和固定在椎间盘空间D中。间隔件部分220′的中心多孔PEEK部分422具有孔隙，该孔隙提供了血液能够通过其流过和骨能够通过其生长的合适通路，以便帮助促进与相邻椎骨本体V的熔合和在相邻椎骨本体V之间的熔合。多孔PEEK部分422可以从间隔件部分220′的顶表面22延伸至底表面24。也可选择，间隔件部分220′可以包括桥接件424。当间隔件部分220′包括桥接件424时，第一和第二盲钻孔426、428优选是分别从顶表面和底表面22、24延伸至桥接件424。盲钻孔426、428可以包括锥形侧表面430，使得盲钻孔426、428的直径朝着间隔件部分220′的中心增大。桥接件424可以由与间隔件部分220′的其余部分相同的材料来形成，但是优选是由多孔PEEK构成。也可选择，桥接件424可以除去，例如能够从间隔件部分220′脱出，以便提供轴向通孔。在操作中，盲钻孔426、428优选是充满骨移植物或其它熔合促进材料，且植入体200′植入在相邻椎骨本体V之间的椎间盘空间D中。盲钻孔426、428的可选锥形侧壁430有助于在盲钻孔426、428内产生熔合时固定植入体200′在椎间盘空间D内的位置。
下面将参考图10A－10E介绍示例插入仪器500和用于插入植入体200的方法。结合示例方法，推进器310将在未附接在板部分250上时被介绍和表示。不过，示例方法可以很容易地用于在推进器310预先附接在板部分250上的情况下操作，或者用于通过植入体10的第一优选实施例来操作，如本领域普通技术人员根据阅读本申请可知。
插入仪器500设置成与推进器310连接、与板部分250连接、将植入体200至少局部插入椎间盘空间D中、允许将骨固定元件70插入骨固定孔40中、将推进器310固定在板部分250上(如果需要)、以及使得推进器310从第一位置旋转至第二位置(如果需要)。
优选是，插入仪器500包括内部杆520和外部管形部件530。内部杆520优选是包括用于与形成于保持螺钉320上的接合特征321相接的远侧接合特征525，例如星形驱动器。优选是，外部管形部件530包括远侧接合特征535，用于与形成于板部分250上的相应接合特征(未示出)相接。因此，仪器500通过使得形成于仪器500的内部杆520上的接合特征525固定在推进器310上而保持推进器310。仪器500通过用形成于外部管形部件530上的接合特征535抓紧板部分250而保持植入体200。
内部杆520设置成在外部管形部件530内沿仪器500的纵向轴线501平移。因此，内部杆520和(因此)推进器310可以相对于外部管形部件530(和因此相对于植入体200)向近侧平移。对于推进器310未附接在板部分250上且板部分250并不包括一个或多个止动器的实施例，仪器500还可以包括一个或多个止动器(未示出)，以便防止植入体200过度插入椎间盘空间D中以及在骨固定元件70的植入过程中固定植入体200相对于椎间盘空间D的位置。
在操作中，外科医生通过使用仪器500来将植入体200插入椎间盘空间D内，以便使得植入体200前进至在相邻椎骨本体V之间的椎间盘空间D内，直到一个或多个止动器(未示出)抵靠椎骨本体V的前侧(或者侧部或前－侧部)。然后，骨固定元件70穿过骨固定孔40插入椎骨本体V中，同时通过止动器与椎骨本体V的相互作用而限制植入体200的滞后。
如果未附接，推进器310和保持螺钉320可以再通过使得内部杆520相对于外部管形部件530向远侧平移而前进至形成于板部分250中的相应钻孔263中。然后，内部杆520旋转，以便使得推进器310从它的第一位置运动至它的第二位置，从而防止植入的骨固定元件70退出。然后，仪器500与推进器310和保持螺钉320脱开。
参考图11A－11C，可选的插入器和钻引导仪器600能够用于插入任意前述植入体10－200以及用于对齐锥子、钻、驱动器仪器等的轨道，用于导向孔的形成和/或骨固定元件的插入。插入器和钻引导仪器600包括从一对手柄620、625伸出的一对臂610、615，该对手柄620、625在枢转点630处连接。臂610、615分别包括在它们远端处的瞄准筒612、616，用于对齐锥子、钻、骨固定元件等的轨道。筒612、616分别包括布置在它们的外表面上的引导肋613、617，用于与形成于植入体200的骨固定孔40中的键625相接。相接的引导肋613、617和键625设置成限制植入体10－200相对于仪器600的旋转，该特征对于只有两个骨固定孔40的植入体10－200特别优选。
在操作中，插入器和钻引导仪器600的臂610、615通过将手柄620、625挤压在一起而打开，筒612、616插入形成于板部分250中的骨固定孔40中，使得引导肋613、617与键625相接。在牢固抓紧植入体10－200时，臂610、615锁定就位，且仪器600可以用于将植入体10－200插入至少局部清除的、在椎骨本体V之间的椎间盘空间D中。然后，筒612、616可以用于对齐锥子、钻等的轨道，以便形成用于骨固定元件70的导向孔，或者可以在使用自钻孔骨固定元件70的情况下对齐骨固定元件70的轨道。在植入骨固定元件70之后，臂610、615打开，插入器和钻引导仪器600与植入体组件脱开。
尽管前述说明和附图表示了本发明的优选实施例，但是应当知道，在不脱离由附加权利要求限定的本发明精神和范围的情况下可以进行多种附加、变化、组合和/或代替。特别是，本领域技术人员应当知道，本发明可以以其它特殊形式、结构、布置、比例和通过其它元件、材料和部件来实施，而并不脱离本发明的精神或实质特征。本领域技术人员应当知道，在本发明的实际使用中，本发明可以用于多种变化的结构、布置、比例、材料和部件等，它们特别适合特殊情况和操作需要，而并不脱离本发明的原理。此外，这里所述的特征可以单独或与其它特征组合地使用。因此，这里所述的实施例在所有方面都被认为是示例性和非限定的，本发明的范围将由附加权利要求来表示，而不是限定为前述说明。

Claims (15)

1.一种椎间植入体，其包括：
间隔件部分，所述间隔件部分限定了间隔件后表面和与间隔件后表面相对的间隔件前表面；以及
板部分，所述板部分限定了板后表面和与板后表面相对的板前表面，所述板部分还限定了顶表面和与顶表面相对的底表面，所述板部分设置成与间隔件部分连接，使得板前表面面向间隔件后表面，所述板部分限定凹口，所述凹口设置成接收植入体插入工具，所述凹口部分地由板后表面限定，部分地由顶表面限定。
2.根据权利要求1所述的椎间植入体，其中所述板前表面相对于第一方向与板后表面相对，所述凹口朝着板前表面延伸并终止于第一表面处，所述第一表面面向与第一方向相对的方向。
3.根据权利要求2所述的椎间植入体，其中，所述底表面相对于第二方向与顶表面相对，所述凹口从顶表面延伸并终止于第二表面处，所述第二表面面向与第二方向相对的方向。
4.根据权利要求3所述的椎间植入体，其中，沿平行于第二方向的直线测量的从第二表面到顶表面的第一距离小于沿所述直线测量的从第二表面到底表面的第二距离。
5.根据权利要求4所述的椎间植入体，其中，沿平行于第一方向的直线测量的从第一表面到板后表面的第三距离小于沿平行于第一方向的所述直线测量的从第一表面到板前表面的第四距离。
6.根据权利要求3所述的椎间植入体，其中，所述凹口为第一凹口，所述板部分限定了第二凹口，所述第二凹口设置成接收植入体插入工具，所述第二凹口部分地由板后表面限定，部分地由底表面限定。
7.根据权利要求6所述的椎间植入体，其中，所述第一凹口朝着板前表面延伸并终止于第一表面处，所述第一表面面向与第一方向相对的方向，所述第一凹口从顶表面延伸并终止于第二表面处，所述第二表面面向与第二方向相对的方向。
8.根据权利要求7所述的椎间植入体，其中，所述第二凹口朝着板前表面延伸并终止于第三表面处，所述第三表面面向与第一方向相对的方向。
9.根据权利要求8所述的椎间植入体，其中，所述第二凹口从底表面延伸并终止于第四表面处，所述第四表面面向第二方向。
10.根据权利要求9所述的椎间植入体，其中，沿平行于第二方向的第一直线测量的从第二表面到顶表面的第一距离小于沿所述第一直线测量的从第二表面到底表面的第二距离，沿平行于第二方向的第二直线测量的从第四表面到底表面的第三距离小于沿所述第二直线测量的从第四表面到顶表面的第四距离。
11.根据权利要求10所述的椎间植入体，其中，所述第一距离等于第三距离，所述第二距离等于第四距离。
12.根据权利要求6所述的椎间植入体，其中，所述椎间植入体设置成被插入位于上部椎骨本体和下部椎骨本体之间的椎间盘空间中，使得所述顶表面面向上部椎骨本体，底表面面向下部椎骨本体，所述板部分限定了骨固定孔，所述骨固定孔设置成接收骨固定元件，以便将椎间植入体与上部椎骨本体和下部椎骨本体中的一个固定。
13.根据权利要求12所述的椎间植入体，其中，骨固定孔是第一骨固定孔，板部分限定了第二骨固定孔，所述第二骨固定孔设置成接收骨固定元件，以便将椎间植入体与上部椎骨本体和下部椎骨本体中的另一个固定，第一凹口和第二凹口相对于第三方向都定位在第一骨固定孔和第二骨固定孔之间，所述第三方向垂直于第一方向和第二方向。
14.根据权利要求12所述的椎间植入体，还包括保持机构，所述保持机构设置成防止被插入骨固定孔中的骨固定元件退出所述骨固定孔，其中，所述保持机构包括钻孔，所述钻孔由板部分限定而成，所述钻孔与第一凹口和第二凹口间隔开。
15.一种成套用具，包括：
根据权利要求1-14中任一项所述的椎间植入体；以及
设置成被插入凹口中的植入体插入工具。
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