CN102892387A - 椎间植入物以及移植物输送系统和方法 - Google Patents

椎间植入物以及移植物输送系统和方法 Download PDF

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Publication number
CN102892387A
CN102892387A CN2011800205171A CN201180020517A CN102892387A CN 102892387 A CN102892387 A CN 102892387A CN 2011800205171 A CN2011800205171 A CN 2011800205171A CN 201180020517 A CN201180020517 A CN 201180020517A CN 102892387 A CN102892387 A CN 102892387A
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implant
spinal implant
spinal
graft materials
inner chamber
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CN102892387B (zh
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吉姆·R·林恩
鲁塞尔·W·纳尔逊
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Pinnacle Spine Group LLC
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Pinnacle Spine Group LLC
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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)

Abstract

根据一些实施方式,一种用于利用脊柱植入物促进脊柱融合的方法包括:提供脊柱植入物,其中,该脊柱植入物包括前壁、后壁和构造成在该前壁与该后壁之间延伸的两个横向壁。在一些实施方式中,该脊柱植入物还包括大致放置在该前壁、该后壁与两个横向壁之间的至少一个内腔,其中,该内腔适于接收至少一种移植材料和/或其它填充材料。在一些布置中,该脊柱植入物的前壁包括将内腔放置成与脊柱植入物的外部区域或部分流体连通的至少一个开口或孔。在一个实施方式中,这两个横向壁中的至少之一包括进入端口。该方法还包括将脊柱植入物放置在患者的两个相邻的椎骨之间,并将至少一种移植材料和/或其它填充材料经该进入端口引导到该脊柱植入物的内腔中。在一些实施方式中,输送到内腔中的移植材料和/或其它填充材料的至少一部分构造成通过前壁的一个或更多个开口离开。

Description

椎间植入物以及移植物输送系统和方法
优先权信息
本申请根据美国法典第35条第119(e)款要求于2010年3月16日提交的美国临时专利申请No.61/314,509和于2010年10月4日提交的美国临时专利申请No.61/389,671的权益,由此,这两篇专利申请的全部内容以参引的方式被结合于此。
技术领域
本申请主要涉及一种脊柱融合过程,并且更为具体地,涉及脊柱植入物以及相关的系统、工具和方法。
背景技术
椎间盘会随时间的流逝而退化或在不同的情况下受损。在一些情况下,可将椎间植入物放置在被椎间盘预先占据的空间内。这种植入物可有助于维持相邻的椎骨之间的所需间距和/或促进相邻的椎骨之间的融合。骨移植物和/或其它材料在脊柱植入物内的使用可促进相邻的椎骨体的融合。因此,存在对改良的椎间植入物以及相关的器械、工具、系统和方法的需求。
发明内容
根据一些实施方式,一种被构造为用于放置在患者的椎间空间之内的脊柱植入物包括:前壁、后壁、第一横向壁和第二横向壁,以使得该第一和第二横向壁大体在前壁和后壁之间延伸。该脊柱植入物另外还包括至少一个内腔,该至少一个内腔至少部分地被前壁、后壁和第一和第二横向壁限定。在一些实施方式中,该植入物包括顶部表面和/或底部表面,该顶部表面具有构造成至少部分地接合第一椎骨体的下表面的多个齿部,该底部表面包括构造成至少部分地接合第二椎骨体的上表面的多个齿部,该第二椎骨体与所述第一椎骨体相邻。在一些实施方式中,该至少一个内腔至少部分地从植入物的顶部表面延伸至该植入物的底部表面。该植入物还包括延伸通过前壁的至少一个开口,其中,这种开口与内腔流体连通。在一些实施方式中,脊柱植入物另外包括设置在前壁、第一横向壁和/或第二横向壁中的至少一个进入端口。在一些实施方式中,该植入物构造成利用该进入端口可松开地固定至插入工具。在一些实施方式中,该植入物构造成横越相邻的椎骨体的整个宽度或大致整个宽度。在一些实施方式中,该进入端口构造成接收输送到该至少一个内腔中的至少一种移植物材料。在一些实施方式中,后壁不包括任何开口。
根据一些实施方式,通过该进入端口输送到该至少一个内腔中的过量的移植材料构造成通过前壁的一个或更多个开口离开该植入物。在一个实施方式中,该进入端口带有螺纹,使得可将包括对应的螺纹样式的输送工具选择性地附接至该脊柱植入物以及从该脊柱植入物上拆下。在一些实施方式中,该植入物包括一个或更多个凹处和/或其它特征,该一个或更多个凹处和/或其它特征构造成与植入物输送工具上的对应的凸缘或其它突出构件相匹配。在一个实施方式中,第一横向壁和第二横向壁中的每一个构造成与相邻的椎骨体的外围支承区域大致对齐。在其它实施方式中,沿着植入物的顶部表面和/或底部表面的齿部构造成朝向植入物的横向中心倾斜。在一些实施方式中,该倾斜的齿部有助于在植入之后将植入物保持在目标椎间空间内和/或有助于减少移植材料沿着植入物的顶部表面和底部表面离开该植入物的至少一个内腔的迁移的可能性。
根据一些实施方式,第一横向壁和/或第二横向壁包括锥形部分,以便于植入物插入到椎间空间中。在一个实施方式中,该脊柱植入物还包括多个延伸到内腔中的尖头,用于保持放置在其中的移植物或其它构件。在一些实施方式中,这种尖头构造成将海绵、多孔泡沫和固化的移植材料中的至少一种保持在植入物的至少一个内腔内。在一些实施方式中,该植入物构造成用于放置在患者脊柱的腰部或胸部部分内。在一些实施方式中,该植入物构造成用于至椎间空间中的横向或前部插入。在若干个实施方式中,该植入物包括聚醚醚酮(PEEK)和/或其它材料。
根据一些实施方式,第一横向壁和第二横向壁中的每一个的长度为植入物的整个长度的约10%至20%。在其它实施方式中,第一横向壁和第二横向壁中的每一个的长度小于植入物的整个长度的约10%或大于植入物的整个长度的约20%。在一个实施方式中,沿着植入物的顶部表面和/或底部表面中的至少一个的齿部至少部分地以同心的方式定向。在一个实施方式中,沿着植入物的顶部表面和底部表面中的至少一个的齿部的曲率半径随着与植入物的中心的距离的增大而增大。在一些布置中,植入物的顶部表面和/或底部表面为大致平面的。在其它实施方式中,植入物的顶部表面和/或底部表面为大致弯曲的、带有沟槽的、圆形的和/或非平面的。
根据一些实施方式,该植入物包括脊柱前凸的植入物,使得第一横向壁的高度大于第二横向壁的高度。在一些实施方式中,内腔不包括任何内部壁或隔壁。在替代实施方式中,内腔包括由至少一个内部壁或隔壁分开的至少两个内部子腔。在一个实施方式中,植入物包括至少一个不透射线的标记。在若干个实施方式中,进入端口为大致圆形的。在其它实施方式中,该进入端口为非圆形的(例如,正方形的、其它矩形的或多边形的、卵形的、椭圆形的、不规则的形状等)。
根据一些实施方式,进入端口包括约6mm的最小直径。在其它实施方式中,进入端口的直径或其它横截面尺寸大于或小于约6mm(例如,4mm、5mm、7mm、8mm等)。在一些实施方式中,进入端口适于接收通过其中的填充管、导管或其它管路,其中,这种填充管、导管或其它管路构造成将移植材料或填充材料选择性地输送到植入物的内腔中。在一些实施方式中,该至少一个进入端口的直径与穿设有该至少一个进入端口的第一横向壁或第二横向壁的高度的比率为约0.4与0.8之间(例如,约0.4、0.45、0.5、0.55、0.6、0.65、0.7、0.75、0.8、0.85、0.9等)。在一个实施方式中,该至少一个进入端口的直径与穿设有该至少一个进入端口的第一横向壁或第二横向壁的高度的最小比率为约0.5、0.6、0.7或0.8。
根据一些实施方式,该进入端口包括阀或其它流体阻塞装置或特征,以有助于将移植材料保持在植入物的至少一个内腔内。在一些实施方式中,前壁的外部轮廓为大致弯曲的。在一些布置中,后壁的外部轮廓为大致平面的。
根据一些实施方式,一种用于促进脊柱融合的方法包括:提供脊柱植入物(例如,于此公开的植入物中的一个或其等效物)并将脊柱植入物放置在患者的两个相邻的椎骨体或椎骨之间。该方法还包括将至少一种移植物材料经植入物的端口引导到脊柱植入物的内腔中。在一些实施方式中,将输送到该至少一个内腔中的移植材料和/或其它填充材料(例如,超过植入物的容量的材料)的至少一部分构造成在已将足量的至少一种移植材料输送到该至少一个内腔中时经前壁的一个或更多个开口离开。
根据一些实施方式,将脊柱植入物放置在两个相邻的椎骨体之间包括将脊柱植入物可释放地固定至插入工具组件的远侧端部,其中,将该插入工具组件至少部分地固定至脊柱植入物的进入端口。在一些实施方式中,将该进入端口既用于将植入物固定至植入物输送工具又用于将移植材料和/或其它材料输送至植入物的内部。在一些实施方式中,将移植材料和/或其它材料引导到内腔中包括使这种材料通过插入工具组件的管状部分。在其它实施方式中,将材料引导到内腔中包括使该材料通过单独的管路,该单独的管路适于可移除地放置在脊柱植入物的进入端口内。在一个实施方式中,将移植材料和/或其它材引导到内腔中包括利用注射器经管子注射这种材料。
根据一些实施方式,将管子的路线定为穿过填充管组件的内部通道,其中,该填充管组件构造成在将移植材料和/或其它材料引导到植入物的内腔中的同时,接合脊柱植入物的至少一部分。在一些实施方式中,将输送到内腔中的移植材料的至少一部分构造成通过处于植入物的上表面和/或下表面与椎骨体的相邻终板表面之间的界面离开。在一些实施方式中,在将脊柱植入物放置在两个相邻椎骨体之间之前,内腔的至少一个部包括移植材料。在一些实施方式中,在已将该脊柱植入物固定在两个相邻的椎骨体之间之后,将附加量的移植材料输送到植入物的内腔中。
根据一些实施方式,该方法还包括为脊柱植入物的输送准备至少一个相邻的椎骨体表面,其中,准备相邻的椎骨体表面包括利用锉磨工具和/或其它磨擦或粗化工具来磨擦所述表面。在一些实施方式中,这种工具包括一个或更多个粗糙表面或特征,该一个或更多个粗糙表面或特征构造成磨擦骨和/或其它组织。在一些实施方式中,该方法另外包括在将脊柱植入物放置在患者的两个相邻的椎骨体之间之前,将定尺寸工具放置在目标椎间空间内,以确定所述脊柱植入物的适当的尺寸。在一些实施方式中,该定尺寸工具构造成将相邻的椎骨体撑开所需要的距离。
根据一些实施方式,一种套件包括:脊柱植入物(例如,于此公开的那些套件中的任何一个或其等效物)、构造成可移除地固定至脊柱植入物的植入物输送工具以及构造成将至少一种移植材料和/或其它填充材料选择性地输送到脊柱植入物的内部(例如,内腔)中的移植材料输送系统。在一些布置中,该移植材料输送系统包括构造成穿过脊柱植入物的至少一个进入端口的管路、定尺寸工具和注射器。
根据一些实施方式,一种用于利用脊柱植入物促进脊柱融合的方法包括:提供脊柱植入物,其中,该脊柱植入物包括前壁、后壁和构造成在前壁与后壁之间延伸的两个横向壁。在一些实施方式中,该脊柱植入物还包括至少一个内腔,该至少一个内腔大致设置在前壁、后壁与两个横向壁之间,其中,该内腔适于接收至少一种移植材料和/或其它填充材料。在一些布置中,该脊柱植入物的前壁包括将内腔放置成与脊柱植入物的外部区域或部分流体连通的至少一个开口或孔。在一个实施方式中,这两个横向壁中的至少一个包括进入端口。该方法另外包括将脊柱植入物放置在患者的两个相邻的椎骨之间以及将至少一种移植材料和/或其它填充材料经进入端口引导到脊柱植入物的内腔中。在一些实施方式中,将输送到内腔中的移植材料和/或其它填充材料的至少一部分构造成通过前壁的一个或更多个开口离开。
在一些实施方式中,将脊柱植入物放置在两个相邻的椎骨之间包括将脊柱植入物可移除地固定至插入工具组件的远侧端部,其中,将该插入工具组件至少部分地固定至脊柱植入物的进入端口。在一个实施方式中,将移植材料引导到内腔中包括使该移植材料穿过插入工具组件的管状部分。在一些实施方式中,将移植材料引导到内腔中包括利用注射器通过柔性管子注射一种或更多种移植材料。在一些实施方式中,将该柔性管子的路线定位穿过填充管组件的内部通道,其中,将该填充管组件构造成在将移植材料引导到内腔中的同时接合脊柱植入物的至少一部分。在一些布置中,将输送到内腔中的移植材料和/或其它填充材料的至少一部分构造成通过位于脊柱植入物的上表面和/或下表面与椎骨体的相邻终板表面之间的界面离开。在一个实施方式中,在将脊柱植入物放置在两个相邻的椎骨体之间之前,内腔的至少一部分包括移植材料。在一些实施方式中,这种预载的移植材料或物品包括移植物、吸收性海绵或其它构件等。
根据一些实施方式,一种构造成用于放置在患者的椎间空间内的植入物包括:前壁、后壁、第一横向壁和第二横向壁,其中,第一横向壁和第二横向壁构造成在前壁与后壁之间延伸。该植入物还包括顶部表面和底部表面,该顶部表面具有适于至少部分地接合第一椎骨体的下表面的多个齿部,该底部表面具有适于至少部分地接合第二椎骨体的上表面的多个齿部,其中,该第二椎骨体与第一椎骨体相邻。该植入物还包括设置在前壁、后壁、第一横向壁和第二横向壁之间的一个或更多个内腔,其中,该内腔至少部分地从植入物的顶部表面延伸至植入物的底部表面。
在一些实施方式中,该植入物另外包括延伸通过前壁的至少一个开口,其中,该开口与内腔流体连通。在一个实施方式中,该植入物还包括设置在前壁、第一横向壁和/或第二横向壁中的至少一个进入端口,其中,该植入物构造成利用该进入端口可移除地固定至插入工具。在一些实施方式中,该进入端口构造成在已将植入物固定在椎间空间内之后,接收输送到内腔中的移植材料。在一个实施方式中,后壁不包括任何开口。在一些布置中,输送到内腔中的移植材料构造成通过前壁的至少一个开口离开该植入物。
根据一些实施方式,该植入物包括聚醚醚酮(PEEK)。在若干布置中,第一横向壁和第二横向壁中的每一个的长度为植入物的整个长度的约10%至20%。在一些实施方式中,第一横向壁和第二横向壁中的每一个构造成与相邻的椎骨构件的外围支承区域大致对齐。在一些实施方式中,沿着植入物的顶部表面和/或底部表面设置的多个齿部构造成朝向植入物的横向中心倾斜。在一个实施方式中,第一横向壁和/或第二横向壁包括锥形部分,以便于植入物到椎间空间中的插入。在一些布置中,植入物构造成用于到目标椎间空间中的横向、前部或后部插入。在一些实施方式中,植入物构造成用于放置在患者脊柱的腰部或胸部部分内。在一个实施方式中,植入物另外包括延伸到内腔中的尖头,用于保持放置在其中的移植物或其它构件。
附图说明
参考某些实施方式的附图描述本申请的这些和其它特征、方面和优点,附图预计用于举例说明、但并不限制本公开。将会明白的是,这些附图出于举例说明本公开的原理并且可不按比例绘制。
图1A示出了根据一个实施方式的脊柱植入物的主视立体图;
图1B示出了图1A的植入物的后视立体图;
图2示出了图1A的植入物的俯视图;
图3A示出了图1A的植入物的侧视图;
图3B和3C示出了图1A的植入物的侧视详图;
图4和5示出了图1A的植入物的不同的侧视图;
图6A示出了根据一个实施方式的植入物以及构造成接合该植入物的插入工具的立体图;
图6B示出了根据一个实施方式的脊柱植入物的局部俯视图;
图6C示出了根据一个实施方式的脊柱植入物的立体图;
图6D示出了根据一个实施方式的脊柱植入物的俯视图;
图7A示出了根据一个实施方式的植入物的前侧视图,该植入物处于目标椎间空间内并固定至插入工具组件;
图7B示出了图7A的植入物的横向侧视图;
图8示出了定尺寸和撑开工具的两个实施方式;
图9示出了用于在植入脊柱植入物之前用作准备工具的锉磨或磨擦工具的一个实施方式;
图10A和10B示出了用于准备椎间空间的锉磨或磨擦工具的另一实施方式的立体图;
图11示出了根据一个实施方式的附接至脊柱植入物的插入工具组件的立体图;
图12A示出了图11的插入工具组件和植入物的分解立体图;
图12B示出了根据一个实施方式的固定至植入物的插入工具组件的局部横截面视图;
图13示出了根据一个实施方式的移植物填充套件的多种部件的立体图;
图14示出了根据一个实施方式的填充工具组件的前侧视图,该填充工具组件与放置在目标椎间空间内的脊柱植入物接合;
图15示出了根据一个实施方式的注射器组件,该注射器组件构造成用于以移植材料或其它填充材料来后填充脊柱植入物;
图16A-16C示出了根据一个实施方式的与将注射器组件放置在填充工具组件内相关的按时间排顺的步骤的多幅视图;
图17A和17B示出了根据一个实施方式的已离开脊柱植入物的内腔的过量的移植材料和/或其它填充材料的不同的侧视图;
图18示出了根据一个实施方式的插入工具组件的局部横截面视图,该插入工具组件具有管状的螺杆并且固定至植入物;
图19和20示出了根据一个实施方式的脊柱植入物的不同的俯视立体图;和
图21示出了图19和20的植入物的横截面视图。
具体实施方式
于此所述的多个实施方式和示例举例说明了可用以实现预期改进的多种构造。特定的实施方式和示例仅仅是说明性的而非意欲以任何方式限制所呈现的发明的一般性质和于这些发明相关的多个方面和特征。
脊柱植入物
图1示出了构造成用于放置在患者的相邻的椎骨之间的脊柱植入物10的一个实施方式。根据某些布置,该植入物10被确定尺寸、成形或以其它方式适于用于沿着脊柱的腰部区域放置在椎间空间内。然而,作为选择,于此公开的植入物和/或方法可被修改为用于放置在脊柱的诸如胸部或颈部区域之类的任何其它部分中。在于此公开的任一实施方式中,通过使用横向输送方法(例如,极外侧椎体间融合技术(XLIF)或经椎间孔腰椎间融合术(TLIF))、前路手术(例如,前路椎体间融合术(PLIF))和/或任何其它的方法或技术,可将植入物插入到目标椎间空间中。
继续参照图1,植入物10可包括大致呈矩形的形状。然而,在替代性的构造中,该植入物10包括其它形状,如特定的应用或用途所期望或要求的那样。例如,该植入物的一个或更多个表面或侧面可或多或少为锥形的和/或圆形的(例如,曲线形的、凸起的,等等)。此外,该植入物可包括完全不同的整体形状(例如,如从顶部、底部、一个或更多个侧面等所观察到的那样),例如,圆形的、卵形的、椭圆的、其它多边形的、不规则的等。
根据一些实施方式,植入物10的顶部表面12和/或底部表面16包括一个或更多个齿部40、突出构件和/或其它的特征,这些特征被确定尺寸、成形和以其它方式构造成用以一旦已将植入物放置在椎间空间内,就接触并接合椎骨终板的相邻表面。在一个实施方式中,仅顶部表面12包括齿部或类似的接合特征。在另一实施方式中,仅底部表面16包括齿部或类似的接合特征。然而,在一些实施方式中,顶部表面12和底部表面16都包括齿部或类似的接合特征。
齿部40或其它接合构件或特征可或者完全地或者部分地沿着植入物10的顶部表面12和/或底部表面16分布。例如,该齿部或其它接合特征40可覆盖植入物的整个或基本上整个顶部表面和/或底部表面。在其它布置中,如所期望或所要求的那样,齿部40仅沿着顶部表面和/或顶部表面的选定部分设置。如图1和2中所示,齿部40可从植入物的前端32至少部分地延伸至植入物的后端36。在一些实施方式中,至少一些齿部40是大致彼此平行的。然而,在其它布置中,植入物的至少一些齿部或类似的接合特征40彼此交叉或以其它方式相对于彼此是不平行的。
继续参照图1和2,齿部或其它接合特征40可沿着植入物10的顶部表面12和/或底部表面16对称地放置。然而,作为选择,沿着植入物的顶部表面和/或底部表面的齿部样式可在一个或更多个方向上是不对称的。在所示出的实施方式中,齿部40沿着植入物10的中间部分是大致笔直的,并且沿着植入物10的横向端22、26中的每个均是大体弯曲的(例如,圆形的、卵形的,等)。由此,齿部40沿着植入物的横向端22、26的曲率半径比该齿部沿着植入物的中间部分、中央部分或内部的曲率半径大。在一些布置中,数排齿部40或其它接合特征的曲率半径可随着与植入物10的中心的距离的增大而增大。
如所期望或所要求的那样,沿着植入物10的顶部表面12和/或底部表面16的齿部或其它接合特征40可以是双向的或单向的。这种齿部或其它接合特征40可有助于确保在将该植入物10植入到目标椎间空间内之后,该植入物10不会迁移或者以其它方式不期望地移动。此外,如于此更为详细地讨论的那样,齿部40可有助于将移植材料和/或其它填充材料保持在植入物10内或附近(例如,植入物的内腔内,处于相邻的椎骨构件的端板之间,等等),从而改进和/或促进脊柱融合。如所期望或所要求的那样,齿部或其它接合特征40的类型、质量、形状(例如,沿着植入物的顶部表面和/或底部表面的曲率、沿着齿部的横截面形状,等)、尺寸(高度、长度,等)、方位、间距和/或其它细节可改变。
参照图2的俯视图,植入物10可包括左侧横向侧部L和右侧横向侧部R。根据一些实施方式,沿着植入物10的顶部表面12和/或底部表面16的齿部40为单向的。例如,沿着植入物的左侧横向侧部L的齿部40为大致弯曲的、成斜面的、倾斜的或以其它方式沿第一方向指向,而沿着植入物的右侧横向侧部R的齿部40为大致弯曲的、成斜面的、倾斜的或以其它方式沿第二方向指向,在一些布置中,该第二方向通常与第一方向反向。
此外,如图3A的侧视图中所示,在一些实施方式中,沿着植入物10的上表面12的齿部40’或沿者植入物10的下表面16的齿部40”朝向植入物的水平中心是成斜面的或倾斜的。如上所述,这种构造可有助于确保植入物10接合患者脊柱的相邻部分(例如,椎骨终板表面)并且植入物10在植入后不会不经意地迁移或以其它方式移动。此外,这种实施方式可有助于确保有利地减少输送到植入物10的内腔中的移植剂和/或其它填充材料不合乎要求地从植入物内或其附近(例如,在上表面12和/或下表面16与患者的椎骨的相邻终板之间)离开的可能性或使其最小化。例如,利用这种齿部方位,植入物10需要相对于齿粒(例如,在一个或更多个方向上)迁移或以其它方式偏移,以便在植入之后横向地移动远离目标椎间空间。另外,根据一些实施方式,齿部40的向内定向的形状使得移植材料和/或其它填充材料更难以在植入物—终板界面处或其附近流动或以其它方式移动。
如图3A中所示,植入物10可包括至少部分地沿着它的长度和/或宽度为大致平面的顶部表面12和/或底部表面16。然而,在其它实施方式中,植入物10的顶部表面12和/或底部表面16包括一个或更多个不非平面的部分。这种非平面的区域或部分可仅仅局部地沿着植入物的长度和/或宽度延伸。在其它实施方式中,植入物的整个顶部表面和/或底部表面可大体上是不平面的。
例如,顶部表面和/或底部表面可大致为凹面的、圆形的或其它曲线形的(例如,在竖直方向上为曲线形的,使得植入物的厚度沿着植入物的一个或更多个区域变化)。这种构造可在植入物10与椎骨构件的相邻终板或其它表面或部分之间提供更为紧密的配合。在一些布置中,这种构造可有助于改进或增强脊柱融合过程。在其它一些布置中,植入物可以是大致平面的但是非水平的(例如,从前端至后端)。例如,如于此更为详细地讨论的那样,“脊柱前凸的”植入物设计可包括比后壁大致更高的前壁。
在一些实施方式中,植入物的一个或两个横向端可以是锥形的。如图3A中所示的锥形横向端22可有助于在植入过程期间将设备10插入到目标椎间空间内。在所绘布置中,当从顶部观察时,沿着植入物10的右侧横向端22的前端97既包括竖向的锥度,又包括圆形的剖面。如在下文中更为详细地讨论的那样,在一些实施方式中,该设备的这种“弹头”或锥形横向前端的至少一部分可构造成在将植入物植入其中的椎间空间的外侧延伸。根据一些实施方式,植入物的一个或两个横向端包括圆形的或曲线形的轮廓。如所期望或所要求的那样,这种圆形的或曲线形的轮廓或剖面可被包括在竖直方向、或水平方向、或竖直和水平方向中。
另外,如最佳在图2中所示,当从顶部观察时,植入物的后侧36的外表面可以是大致平面的或平面状的。这种设计可有助于确保在植入物10的后侧端与患者脊柱的敏感部位(例如,神经根、脊髓,等)之间提供恰当的间隙。此外,植入物的前侧32的外表面可包括圆形的或其它非平面状的形状。在一些实施方式中,这种圆形的或其它非平面状的形状为相对平缓或微不足道的。同样,如所示,如所期望或所要求的那样,植入物的横向侧22、26的外部可以或者是大致平面状的(例如,平面的)或圆形的。在其它实施方式中,植入物的侧部的外部形状可不同于于此所绘和所讨论的情况。
为了有助于执行植入过程并便于将植入物输送至患者脊柱内的目标位置,植入物10可包括一个或更多个插入工具接收端口50、槽口和/或其它特征。例如,尤其在图1A、1B、2和3B中所示的实施方式中,沿着植入物10的横向端26中之一设置有单个端口50。然而,在其它构造中,端口50可沿着该设备的任何其它部分设置。端口50的位置可至少部分取决于将会将植入物10(例如,横向地、预先地、在后地,等)插入到患者脊柱中所使用的所期望的方法。例如,在所示布置中,端口50沿着横向端26设置,这主要是因为植入物10被设计成横向地插入到目标椎间空间中。因此,在其它构造中,可沿着植入物的前侧32、后侧36和/或任何其它部分包括插入工具接收端口50。
根据一些实施方式,插入工具接收端口50构造成利用螺纹连接可松开地接合对应的插入工具。例如,端口50可包括内螺纹,该内螺纹被确定尺寸、成形并以其它方式适于匹配插入工具300的外螺纹(图6A)。然而,在其它的布置中,将其它类型的连接特征或设备用于将插入工具可松开地固定至该植入物,例如,压入配合或摩擦配合连接、卡扣配合连接、选项卡式的连接、任何其它标准或非标准的联接件和/或类似的联接件。如于此更为详细讨论的那样,在一些实施方式中,端口50也用作通向植入物的内腔的入口,可将移植材料和/或其它填充材料通过该入口选择性地输送到植入物内。由此,在这种实施方式中,将单个端口50用作植入物输送机构和移植材料通道。在一些实施方式中,端口50包括一个或更多个阀(例如,止回阀、其它单向阀,等)、其它流量调节设备或特征和/或一个或更多个其它密封构件,用以帮助防止或降低移植材料和/或其它填充材料通过这种端口50从植入物的内部不慎遗失的可能性。
如所期望或所要求的那样,端口50可以带有螺纹或不带有螺纹。在一些实施方式中,该端口包括一个或更多个其它的接合件或其它特征,例如,定位槽口、突部、其它突出构件和/或类似的特征。这种特征可从限定端口50的壁或其它表面(例如,在端口的开口的方向上)向内地延伸。根据一些实施方式,端口的形状(例如,横截面形状)为大致圆形的。然而,该端口可包括一个或更多个其它形状,例如,卵形的、椭圆形的、正方形的、矩形的、其它多边形的、不规则的和/或其它形状。
根据一些实施方式,沿着植入物的横向端26的螺纹端口50构造成至少部分地穿过植入物的横向壁98。例如,在一个实施方式中,端口50穿过整个横向壁98并且延伸到该可移植的设备10的一个或更多个内腔70、腔室或其它开口中。根据一些实施方式,端口50被确定尺寸以允许导管、注射器、管子、其它管、管路和/或其它输送设备穿过其中。这种导管或其它输送管或设备可被确定尺寸并构造成允许将移植材料和/或其它材料选择性地注射或以其它方式施加到植入物的一个或多个腔中。在一个实施方式中,该端口被确定尺寸以允许尺寸为法式尺寸12或法式尺寸15(例如,按照法式规格刻度标准)的导管或其它管穿过其中。由此,在这种布置中,端口50可包括约4mm或约5mm的最小内径。然而,在其它实施方式中,端口50可被确定尺寸、成形或者以其它方式构造成允许更大的导管、管或其它的管路通过其中。例如,在一些实施方式中,植入物构造成允许外径为约5mm至8mm(例如,大约5mm、5.5mm、6mm、6.5mm、7mm、7.5mm、8mm,处于前述尺寸之间的尺寸,等)的导管、管或其它管路穿过它的端口50。在其它实施方式中,该端口被确定尺寸和成形以使得外径大于8mm(例如,大约8mm、8.5mm、9mm、大于约9mm,等)的管路能够穿过其中。
在一些实施方式中,螺纹端口50或进入孔包括M6x 1.0构造。然而,如上所述,该端口可包括大于或小于约6mm的公称直径,例如,约4mm、5mm、7mm、8mm、9mm、10mm、大于10mm、在前述数值之间的尺寸等。此外,在包括螺纹端口的实施方式中,如所期望或所要求的那样,沿着该端口的内部的螺纹可与在M6x 1.0构造中的有所不同。例如,螺纹的螺纹类型、样式、高度和/或其它特性可变化。
根据一些实施方式,于此公开的脊柱植入物或其等效物包括沿着它们的侧面的大致封闭的结构。例如,在一些布置中,沿着植入物的外侧壁(例如,横向的、后部的、前部的)的仅有的开口为一个或更多个端口50(例如,被用于使植入物与输送工具接合和/或用于经移植物输送管到达植入物的内部)和/或允许过量的移植材料离开植入物的内腔或其它腔室的一个或更多个开口(例如,沿着植入物的前侧壁的开口60,如图3A中所示)。
根据一些实施方式,通过植入物的壁的端口50或其它开口构造成是尽可能地大的,以用于给定的植入物。这可允许将更大的设备(例如,导管、注射器、管子、其它管路或设备等)放置在其中。例如,如于此更为详细地讨论的那样,端口50可有利地适于接收构造成将移植材料和/或其它填充材料从注射器(或其它供应源)传递至植入物的内部的管。因此,在这种实施方式中,端口50的内径(或其它横截面的间隙尺寸)比填充导管或其它管路的外径(或其它外部尺寸)略大。
在一些实施方式中,端口包括约6mm至8mm的直径(例如,约6mm、6.5mm、7mm、7.5mm、8mm,处于前述数值之间的直径等)。然而,作为选择,如所期望或所要求的那样,端口50的直径或其它横截面尺寸可小于约6mm(例如,大约4mm、4.5mm、5mm、5.5mm、5.9mm,处于前述数值之间的直径等),或者大于约8mm(例如,大约8.1mm、8.5mm、9mm、9.5mm、处于前述数值之间的直径、大于约9.5mm等)。在一些实施方式中,无论植入物的尺寸如何(例如,6mm、8mm、10mm、12mm高的植入物),通常保持端口50的目标直径或其它横截面尺寸。这可有助于确保外科医生或其它临床医生可将所需要的填充管或其它管路插入到植入物的内部内(例如,以便在后填充过程期间输送移植材料和/或其它填充材料)。因此,如于此参照图6B-6D中所示的实施方式所述,端口50所穿过的一个或更多个植入物的壁(例如,横向侧壁)可能需要被加固或以其它方式被强化,以根据植入物的厚度适应所期望的端口直径(例如,6mm、8mm等)。
通过保持相对大的端口直径或其它尺寸,可通过这种端口有利地设置更大的填充管或管路。因此,可减小与使移植材料和/或其它填充材料穿过填充管相关联的摩擦力。这使得能够将移植材料和/或其它填充材料不费力地输送到植入物的内部中(例如,在后填充过程期间)。因此,执行填充过程的外科医生或其它临床医生可更容易地将必需的材料输送穿过该填充管。因而,尽管沿着植入物的一个或更多个壁设置相对大的端口或其它开口是有点违背常识的(例如,由于存在移植材料和/或其它填充材料从植入物中漏出的可能性),但这种尺寸过大的端口可在填充过程期间提供一个或更多个益处和优点。
根据一些实施方式,根据植入物的尺寸,端口直径(或其它端口开口尺寸)与设置端口所穿过的植入物壁的高度(例如,横向壁)的比率为约0.4至约0.9(例如,大约0.4、0.45、0.5、0.55、0.6、0.65、0.7、0.75、0.8、0.85、0.9、前述数值之间的比率等)。例如,在一些实施方式中,端口直径大约为6mm而对应的植入物壁的高度为8mm、10mm、12mm等。由此,该比率可大约为0.75、0.6、0.5和/或类似的数值。在一些实施方式中,端口直径(或其它端口开口尺寸)与设置端口所穿过的植入物壁的高度(例如,横向壁)的比率为至少约0.5、0.55、0.6、0.65、0.7、0.75、0.8、0.85、0.9、大于约0.9和/或类似的数值。
在一些实施方式中,端口50的区域为设置该端口所穿过的壁的整个区域的至少约10%、15%、20%、25%或30%。然而,如所期望或所要求的那样,该端口区域可小于设置端口所穿过的壁的整个区域的约10%、或大于该整个区域的约25%。
如在下文中更为详细讨论的那样,于此公开的植入物可以多种形状、尺寸和构造设置,以便更好地适应它们将被插入并固定于其中的椎间空间。由此,在一些实施方式中,无论设备的实际尺寸、形状和其它细节如何,供应至外科医生或其它临床医生的多种类型的植入物都包括相同的端口50。因此,外科医生或其它临床医生可利用单个插入工具和/或单组其它器械接合并操纵所提供的多种类型的植入物。此外,如上文所述,除了在将植入物输送通过患者的骨骼期间用作用于所使用的工具的固定部位和/或其它接合装置,端口50还可用作用于导管、注射器、管或其它管路的通道。这种管路可被穿过端口50,以在植入物的内腔、腔室或其它部分内选择性地传递移植剂、其它填充材料和/或任何其它设备或物质。在一些实施方式中,在已将植入物固定地放置在目标椎间部位之后以及在已将一个或更多个输送工具与植入物分离开之后,执行将导管和/或其它管路穿过该端口。在其它实施方式中,如于此所公开的那样,可使移植物输送导管或其它管路穿过端口50,以在将植入物输送工具固定至该端口时到达植入物的内部。例如,可使这种导管或管路穿过管状的植入物输送工具的内腔或其它通道。
为了保持端口50的相同的螺纹或其它类型,更小的植入物(例如,具有更小高度的植入物,如6mm、8mm或10mm的设备)的一个或更多个部分可利用附加材料和/或其它支承件沿着或靠近环绕端口50的区域予以加固。例如,如在图6B-6D中所示的实施方式中所绘,沿着或靠近端口50,沿着植入物10的顶部表面和/或底部表面包括附加的植入物材料13(例如,PEEK、其它聚合材料或其它材料等)。这可有利地在保持植入物的必不可少的结构完整性和功能完整性的同时,允许制造包括单一类型的端口50在内的具有多种尺寸的植入物。例如,沿着植入物10的顶部表面和/或底部表面的附加材料或其它加固件13的使用可提供必不可少的针对植入物在输送和/或使用期间会经受的力和力矩的抵抗力。如图6B-6D中所示,在沿着顶部表面和/或底部表面设置有附加的加固材料13的布置中,这种附加材料可至少放置在有助于限定植入物10的齿部40或其它接合特征的沟槽内。由此,沿着这种加固区域的齿部40的深度和大体构造可在植入物的相邻的区域之间有所不同。
此外,植入物10可包括有助于与对应的插入工具接合的一个或更多个附加特征。根据一些实施方式,如例如在图3中所示,该植入物包括沿着横向端26中之一(例如,沿着包括插入工具接收端口50在内的横向端)的两个凹处或槽口28。这种凹处或其它特征28可被确定尺寸、成形、放置、间隔、定向和/或以其它方式适于与插入工具的对应的翼部、突部或其它部分对齐且配合。该凹处、槽口和/或其它接合特征28可有助于外科医生或其它临床医生在涉及移动和重新放置该植入物的外科手术或其它过程期间操纵(例如,旋转)该植入物。此外,这种接合特征28可有助于确保相对于该植入物恰当地放置对应的植入物插入工具(和/或移植物填充工具,如于此更为详细地讨论的那样)。
继续参照尤其是图1A、1B和2中所示的实施方式,脊柱植入物10可包括一个或更多个内腔70。在一个实施方式中,该植入物仅包括单个腔。然而,在替代实施方式中,植入物包括两个或更多个腔。如所示,这种内腔70可延伸穿过整个植入物深度(例如,从顶部表面12延伸至底部表面16)并穿过植入物的大部分长度和宽度。例如,在一些布置中,腔70横越植入物长度和宽度的约60-70%。然而,在其它实施方式中,如由具体应用或用途所期望和要求的那样,腔70可延伸小于植入物长度和/或宽度的约60%(例如,大约30%、35%、40%、45%、50%、55%、60%、小于30%、前述数值之间的百分比等),或延伸超过植入物长度和/或宽度的约70%(例如,大约70%、75%、80%、85%、超过90%、前述数值之间的百分比等)。
在一些实施方式中,植入物包括两个或更多个腔。例如,图1A-5中所示的植入物可包括穿过腔70、大体在前壁92与后壁94之间延伸的一个或更多个分隔壁(未示出)。可与植入物的相邻部分一体形成的这种分隔壁或其它分隔件可有效地在植入物中形成两个或更多个子腔或腔室。在具有两个或更多个腔、子腔、腔室和/或其它开口的植入物布置中,这种腔或子腔可具有相同的或不同的形状和/或尺寸。此外,在分隔壁或其它分隔件中可包括一个或更多个开口,以允许腔彼此之间流体连通。这在以移植材料和/或其它材料填充植入物时是特别重要的(例如,以有助于确保将这种填充材料输送到所有的腔中)。
如图1A和1B中所绘,脊柱植入物10可包括延伸穿过它的前壁92的一个或更多个开口60,但是沿着它的后壁94并没有开口。开口60可与植入物的腔70流体连通。由此,如在下文中更为详细地讨论的那样,(例如,通过植入物中的填充端口50和/或其它开口)输送到腔70中的过量的移植材料和/或其它填充材料可通过开口60朝向脊柱的前部离开。通过消除沿着后壁的开口,可基本上减少或防止填充材料沿着植入物的后侧的通过。由此,在这种植入物内输送的过量的移植剂和/或填充材料中的大半(或几乎所有)均可构造成通过前开口60离开植入物的内部。例如,在一些布置中,超过约70%的(例如,超过约70%、75%、80%、85%、90%、95%等)输送到植入物中的过量的填充材料通过开口60离开。在一些实施方式中,这可有利地有助于防止或减少移植材料和/或其它填充材料朝向脊柱的神经根、脊髓和其它敏感区域迁移的可能性。
继续参照图3A中所示的实施方式的侧视图,植入物10可包括总共五个开口60,这些开口60大致相等地确定尺寸并沿着前壁彼此等距地间隔开。在所绘的构造中,开口60包括卵形形状或带有圆形拐角的大体矩形的形状。作为选择,开口60可包括任何其它的形状(例如,圆形、正方形、矩形、其它多边形、不规则的形状等)。此外,开口60的数量、间距、相对尺寸、方位和/或其它特性可与于此所绘和所讨论的不同。例如,可根据植入物的尺寸设置设计承载能力和/或其它特性、附加的(例如,六个、七个、八个、九个、十个、超过十个等)或更少的(例如,四个、三个、两个、一个)开口。
此外,如连同其它位置一起,在图2的俯视图中所示,植入物10可包括延伸到腔70中的一个或更多个内部尖头或其它突出构件74。如同植入物的其它特征一样,这种尖头74可形成为与植入物的相邻部分成一整体的整体结构。作为选择,该内部尖头74可以是单独的构件,这些单独的构件随后利用诸如螺钉、铆钉、其它紧固件、粘合剂和/或类似的连接设备或方法之类的一个或更多个连接设备或方法固定至植入物。尖头74可沿着植入物的内表面的多个位置放置。例如,在一些实施方式中,如图6A和6C中所示,尖头沿着位于植入物的顶部和/或底部的多个横向部分放置。然而,该内部尖头或其它接合构件可沿着腔70的或者除植入物的顶部部分和/或底部部分或者代替其顶部部分和/或底部部分的任何其它部分或区域设置。
根据一些实施方式,如图6D中所绘,尖头74朝向植入物10的内部腔或腔室70指向。尖头74可相对于内部竖向壁大体垂直地排列,该内部竖向壁限定腔70,并且尖头从该内部竖向壁向内地延伸。由此,尖头中的一个或更多个可沿着相对于植入物10的纵向中心线或横向中心线偏移的线设置。例如,如图6D中所示,一个或更多个尖头74相对于植入物10的横向中心线W偏移角度P。在一些实施方式中,这种角度P为大约20-25%(例如,约20%、25%、30%等)。此外,如图6D中所示,尖头74可包括大体呈锥形的、楔状的、截锥状的、三角形的、金字塔状的和/或其它任何的形状(例如,当从顶部观察时)。然而,尖头74的形状、尺寸、间距、方位和/或其它特性可与于此所绘和所讨论的不同。
无论它们的实际数量、尺寸、形状、间距、方位和/或其它的特性如何,这种尖头或其它特征74可有助于确保将移植剂和/或其它填充材料恰当地保持在植入物10的内腔70内。例如,在一些实施方式中,在植入到患者体内之前或之后,将固态移植物、多孔泡沫结构、海绵和/或其它固态的或非流动性的构件放置在植入物的腔70内。由此,尖头74可有助于接合这种物品并将它们保持在植入物内。在一些实施方式中,尖头74仅在移植材料和/或其它填充材料已经充分地变硬或凝固之后帮助将固定在植入物的腔70内。
如图1A-5中所示,植入物10的厚度(例如,竖向高度)和宽度(例如,前—后距离)可遍及它的整个长度是大体一致的。作为选择,植入物的一个横向端可包括比相对的横向端更大的厚度。当沿着脊柱的脊柱前凸部分插入植入物时可有利地利用这种布置。例如,在这种脊柱前凸的植入物中的相对的端部之间的高度差可相差约2mm。在其它实施方式中,如特定患者或融合过程所期望或所要求的那样,该高度差可小于或大于约2mm(例如,大约0.5mm、1mm、1.5mm、2.5mm、3mm、3.5mm、4mm、大于4mm、前述数值之间的距离等)。
根据一些实施方式,植入物的横向壁96、98的水平宽度可构造成增强该植入物的耐受它一旦被恰当地移植到患者脊柱中时就将经受的支承力、力矩和其它载荷的能力。例如,如图7A的前—后侧视图中所示,植入物10的横向壁96、98可构造成与最高集中度的支承力通过其传递至植入物10的相邻的椎骨V的部分B对齐。通常,这种高承载区域或部分B靠近椎骨V的横向或周向端部设置。通常,如图7A中所示,椎骨V的终板进一步移动远离椎骨体的中心附近的相邻的椎间空间。由此,要求将由相邻的椎骨V形成的大部分的支承载荷朝向植入物10的外围端部集中。
因此,为了提高它的承载能力,植入物10可包括横向壁96、98,横向壁96、98通常被加固并以其它方式适于安全地处理在移植后施加在植入物上的支承载荷。例如,横向壁96、98可比植入物的前壁92和/或后壁94宽(例如,水平地)。在一些实施方式中,横向壁96、98中的每一个的水平长度(例如,沿着植入物的较长轴线)比前壁或后壁的水平宽度大至少约两倍。例如,在一些实施方式中,横向壁96、98中之一或两者的水平长度为植入物的前壁或后壁的水平宽度的大约至少两倍、三倍、四倍或四倍以上。在一些实施方式中,横向壁96、98中之一或者两者的水平长度为该植入物的整个水平长度(例如,沿着该植入物的较长轴线)的大约10%至20%(例如,约10%、12%、14%、16%、18%、20%、前述数值之间的百分比等)。然而,作为选择,如所期望或所要求那样,横向壁96、98中之一或者两者的水平长度可大于植入物10的整个水平长度的约20%或小于该整个水平长度的约10%。因而,植入物的横向端22、26中之一或两者可构造成更好地承受一旦将植入物插入并固定在患者脊柱的目标椎间空间内时它将经受的支承力和力矩。
根据一些实施方式,脊柱植入物被确定尺寸以大体横越相邻的椎骨构件V的整个宽度。由此,如上文中所讨论的那样,植入物的横向壁可与下部或上部的椎骨构件的承载部分大体对齐。在一些实施方式中,如上文中参照图7A所讨论的那样,该植入物主要或仅仅沿着植入物的横向端接触相邻的椎骨构件。由此,植入物的位于该植入物的横向端的内部的部分构造成经受来自相邻的椎骨构件的较少的力或不经受该力。
根据一些实施方式,植入物10包括一个或更多个射线透不性的标记80。这种标记80可有助于外科医生或其它临床医生将植入物恰当地放置在目标椎间空间内,特别是在利用微创手术时更是如此。举例来说,如图1A、1B和2中所示,植入物10可包括总共三个钽或其它类型的射线透不性的标记80’、80”。在所绘布置中,两个标记80’设置于横向端22、26处或其附近,而第三标记80”设置于植入物10的水平中心或其附近。在一个实施方式中,中间标记80”的横向或水平位置恰好位于两个横向标记80’’之间。可以根据应用或用途的具体要求改变标记的数量、类型、位置、方位、间距和/或其它细节。
如图2的俯视图中所示,植入物10的后壁94可包括隆起部分或其它加固区域95,以便容置中央射线透不性的标记80”。除了提供可环绕标记的附加材料之外,这种隆起部分95或类似的特征还可有利地改善植入物的强度和/或其它结构特性。
于此公开的植入物的多种构造可包括一种或更多种材料。例如,在一些实施方式中,植入物包括聚醚醚酮(PEEK)、其它射线可透性的材料、其它热塑性塑料、金属、合金和/或具有所需结构特性(例如,刚度)、机械特性、化学特性和热阻特性和/或其它特性的任何其它的材料。
如于此更为详细地讨论的那样,植入物的尺寸可至少部分地基于患者的体重、身高、年龄、植入物应当提供的椎间撑开的量和/或任何其它因素或考虑因素进行选择。例如,在一些实施方式中,可基于该植入物将被放置到其中的患者的椎间空间的尺寸精确地选择该植入物。例如,植入物的竖向高度可在约8mm与14mm之间(例如,8mm、10mm、12mm、14mm、这种范围之间的数值等)变化。如于此所指出的那样,植入物的竖向高度从前端至后端可以是一致的。作为选择,植入物的竖向高度可在一个或更多个水平方向上(例如,前—后方向、横向方向等)变化。
在一些实施方式中,该植入物包括凹入的或其它非平面状的(例如,穹顶形的、弯曲的等)上表面和/或下表面。这种构造可有助于在植入物与相邻的椎骨的终板表面之间提供改良的接触。此外,植入物的高度可沿着前—后方向变化。例如,在一些实施方式中,植入物的前壁的竖向高度为比后壁的竖向高度高大约2mm。当对脊柱的脊柱前凸部分执行融合时,可有利地利用这种构造。因此,如上文中所指出的那样,于此公开的任何融合植入物均可具有沿着它们的纵向方向变化的竖向尺寸。结果,可提供多种不同的脊柱前凸的植入物,例如,8mm乘10mm(例如,后侧高度乘前侧高度)、10mm乘12mm、12mm乘14mm的植入物和/或同类的植入物。
而且,该植入物可以设置成具有多种水平尺寸,以便更好地适应该植入物将被插入并固定于其中的目标椎间空间。例如,植入物的长度(例如,从一个横向端至另一横向端)可在40mm至60mm之间变化。在一些实施方式中,该植入物设置成具有多种不同的长度,例如,40mm、45mm、50mm、55mm、60mm、前述数值之间的长度等。作为选择,如所需要或所要求的那样,植入物的长度可大于60mm或小于40mm。同样,植入物的宽度(例如,前侧端与后侧端之间的距离)可从植入物到植入物不等,并在特定的植入物设计内变化。例如,在一些实施方式中,植入物的宽度处于约19mm至21mm。如上文中参照图2所讨论的那样,该宽度可沿着植入物的长度变化。在一些实施方式中,宽度上的这种变化由圆形的或曲线形的前侧表面和/或后侧表面产生。由此,在一些实施方式中,植入物在它的纵向中心处(例如,在如图2中所绘的布置中,处于中间标记80”所处的位置处或该位置附近)包括约21mm的宽度并在横向端22、26处或该位置附近包括约19mm的宽度。无论于此提供的具体示例如何,该植入物都可包括任何其它的形状、尺寸或方位。
到目标椎间空间中的植入
在为患者的脊柱融合过程做准备的初始手术步骤尤其可包括:沿着患者的皮肤制造切口并利用一个或更多个扩张器、牵开器和/或其它器械或工具进入脊柱的目标区域(例如,腰部区域)。根据患病的椎间盘或空间的状态,在于患者的骨骼内输送植入物之前,一个或更多个准备步骤是必需的或推荐的。例如,可移除至少一些自然的椎间盘物质以便为植入物的随后插入提供必需的空间。在一些布置中,将撑开工具用于分隔开将会将植入物放置其间的椎骨。
此外,执行该过程的外科医生或其它临床医生可在移植之前选择以确定目标椎间空间的尺寸。例如,可执行这种步骤以便更为精确地选择被恰当地确定尺寸的植入物。此外,外科医生可选择准备将邻接于该植入物的椎骨的一个或更多个自然表面。例如,可利用一个或更多个粗化或磨擦工具来选择性地使邻接于植入物的椎骨终板的一个或更多个部分变粗糙。在某些情况下,这种粗磨步骤可促进康复并可加速在植入物在脊柱内的输送之后的融合过程。
图8示出了撑开和定尺寸工具400A、400B的两个不同的布置,可在脊柱融合过程期间,在输送植入物之前使用这两个撑开和定尺寸工具400A、400B。如所示,撑开和定尺寸工具400A、400B可包括近侧手柄410A、410B(其在图8中仅部分地示出)和远侧头部420A、420B。在所绘的实施方式中,两个工具400A、400B在整体设计上彼此大体相似;然而,它们的远侧头部420A、420B在尺寸上有所不同(例如,竖向厚度、长度等)。可为外科医生提供多个这种撑开和定尺寸工具,以使得他或她能够确定应当将何种类型的植入物插入到目标椎间空间中。这种工具400A、400B也可在移植准备期间用于精确地撑开或分隔开相邻的椎骨。
在一些实施方式中,定尺寸和撑开工具400A、400B包括不锈钢、其它金属或合金和/或适合用于插入到患者的骨骼中并构造成耐受它们将经受的预期的力、力矩和/或其它条件(例如,pH、温度等)的一种或更多种其它刚性材料。继续参照图8,定尺寸和撑开工具400A、400B可包括处于头部420A、420B的远侧端部处或其附近的基线标记430A、430B。在一些实施方式中,外科医生可将工具的头部420A、420B插在目标椎间空间内并推进该工具(例如,在x射线、超声波、透视检查和/或其它成像技术的引导下)直至基线标记430A、430B与相邻的椎骨体的外围远侧边缘恰好或大致对齐。一旦已使得头部的远侧端部对齐,外科医生就可利用近侧标记440A、442A、444A、446A、448A来确定椎间空间的适当的长度。例如,可基于与相邻的椎骨体的外围近侧边缘最为靠近的近侧标记来确定该长度。由此,可利用一种或更多种成像技术而使标记440A、442A、444A、446A、448A显现,用以确定用于目标椎间空间的恰当的植入物尺寸。
同样,外科医生可试图将具有变化的头部厚度的工具400A、400B放置到目标椎间空间内,以确定所需要的植入物高度。因此,可将定尺寸和撑开工具400A、400B用以选择用于插入到患者脊柱中的适当的植入物。在一些实施方式中,可将这种工具400A、400B用以在目标椎间空间内形成所需要的竖向撑开高度,特别是在相邻的椎骨体彼此不合乎要求地靠近的情况下(例如,由于严重的椎间盘退变和/或疾病所导致)更是如此。
图9示意性地示出了刮刀500的一个实施方式,该刮刀500构造成选择性地锉磨、磨擦和/或以其它方式损害或移除组织。在一些布置中,刮刀500被插入到椎间空间中以移除椎间盘组织和/或准备用于随后输送脊柱植入物的椎骨终板表面。如所示,刮刀500可包括沿着纵向轴510的远侧端部放置的磨擦组件520。该磨擦组件520可包括设置在一对锥形外部部分530A、530B之间的中央或主要部分534。在一些实施方式中,该中央部分534包括一个或更多个磨擦构件540,该磨擦构件540适于接触并且至少部分地移除、磨擦或以其它方式影响组织。由此,随着轴510围绕纵向轴线514旋转,磨擦构件540可有助于在为融合设备的后续植入作准备的过程中移除自然的椎间盘组织和/或攻击终板壁。在一些实施方式中,如图9中所示,刮刀500包括锥形的或较低剖面的外部部分530A、530B,以减少或防止对椎骨构件V的外围支承区域B(参见图7A)的损害。通过避免或减少对相邻椎骨的这些自然的承载部分B的损害的可能性,可保持患者脊柱的结构完整性,并由此保持融合过程的结构完整性。
图10A和10B中示意性地示出了刮刀器器械550的不同的实施方式。如所示,刮刀550包括主要部分560,该主要部分560成形、确定尺寸并以其它方式构造成用于输送到目标椎间空间中。主要部分的上表面和下表面可包括或可不包括齿部或其它接合特征或构件。在一些布置中,该主要部分560包括中央腔或其它开口57,该中央腔或其它开口570大体地从主要部分560的顶部表面延伸至底部表面。如图10A中所示,进入端口或开口564可提供从主要部分560的横向侧面到中央腔570的内部的通道。磨擦组件590可沿着长形构件580的远侧端部放置。该长形构件580可被确定尺寸、成形并以其它方式适于穿过主体的进入端口564。同样,磨擦组件590可构造成放置在主要部分560的腔570内。根据一些实施方式,磨擦组件590构造成用于在长形构件580围绕纵向轴线582旋转时在中央腔570内选择性地运动。
继续参见图10B,磨擦组件590可包括大体水平的构造。如所示,该磨擦组件590可包括放置在长形构件580的每一侧上的一个或更多个横向翼部592。在一些实施方式中,每个翼部592的外表面594均可包括适于接触并至少部分地移除或损坏组织的一个或更多个磨擦构件或特征596。在一些布置中,当处于所示的较低剖面或收藏方位中时,磨擦组件590完全地保持在中央腔570内。由此,在不受到磨擦组件590的干预的情况下,可将刮刀550输送至患者的脊柱。一旦被恰当地放置在目标椎间空间内,外科医生或其它临床医生可选择性地旋转该长形构件580以使远侧翼部592朝向相邻的组织(例如,自然的椎间盘组织、终板表面等)移动。由此,磨擦组件590的继续且重复的旋转可在为将植入设备输送至椎间空间做准备时,导致相邻椎骨构件的所需量的磨擦。在一些实施方式中,刮刀550的中央腔570与相邻的椎骨在外围支承区域B(图7A)之间的中央部分大致对齐。由此,可减小或避免对于椎骨的承载区域B的损害,这是由于磨擦组件590将被大体限制于相邻的椎骨构件的有限的中央部分。结果,如上文所指出的那样,可有利地保持椎骨构件的相邻的支承区域的结构完整性。
图11示出了与于此公开的脊柱植入物相同或类似的脊柱植入物10的立体图,该脊柱植入物10被固定至根据一个实施方式的插入工具组件300的远侧端部。图12A中提供了图11的插入工具组件300的分解视图。如图11和12A中所示,该插入工具300可包括具有远侧端部312的外部长形构件310,该远侧端部312适于可释放地接合脊柱植入物10。在一些实施方式中,外部长形构件310的远侧端部312包括一对翼部或突部314,这对翼部或突部314被确定尺寸、成形并以其它方式构造成接合植入物10的对应的凹处或槽口28(图1A)。
继续参照图11和12A,外部长形构件310可包括从插入工具组件300的近侧端部320延伸至其远侧端部312的内部通道316。由此,在一些实施方式中,外部长形构件310是管状的。该组件300的近侧部分320可包括手柄322和外展端328。根据一些实施方式,外部长形构件310在手柄处或其附近包括一个或更多个窗324。如在下文中更为详细讨论的那样,这种窗可允许触及指轮或其它可动控制构件,该指轮或其它可动控制构件提供日光或通过窗423裸露出来。
如图11和12A中所绘的那样,外部长形构件310可构造成将螺杆340可滑动地接收在其内部通道或开口316内。在一些实施方式中,该螺杆340包括具有螺纹远侧端部346的主要长形部分344。该螺纹远侧端部346可被成形、确定尺寸并以其它方式适于接合脊柱植入物的对应的端口50(图1A)。图12B中示出了螺杆340的远侧端部346与植入物10的端口50之间的这种螺纹接合的局部横截面视图。当将该主要长形部分344恰当地插在外部构件310的管状开口内时,螺纹远侧端部346可通过开口316的远侧端部、大体在外部构件310的翼部或突部314之间延伸。
如于此所描绘的那样,螺杆340的近侧端部可包括大体圆柱形的指轮348,该指轮348包括比相邻的主要长形部分344大的直径。根据一些实施方式,当恰当地组装插入工具组件300以供使用时,指轮348的至少一部分是可通过外部长形构件310的窗324触及的。由此,外科医生或其它临床医生可在握住该插入工具组件300的同时选择性地旋转该指轮348以将植入物接合于该组件的远侧端部或者将其从该组件的远侧端部上拆下。该指轮348可包括可有助于螺杆相对于该外部长形构件310的旋转的多个纵向沟槽349和/或其它特征。
继续参照图11和12A,一旦已将螺杆340恰当地放置在该外部长形构件310的近侧端部中时,可将锤垫或撞击垫360固定至该近侧端部。根据一些实施方式,该锤垫360包括构造成接合外部长形构件310的对应的螺纹或特征的远侧螺纹366或其它接合特征。由此,可将锤垫360可释放地附接至外部长形构件310。
一旦已准备好该目标椎间空间(例如,根据所期望或所要求的方案),就可将脊柱植入物10固定至插入工具组件300的远侧端部312。例如,如上文所讨论的那样,可将螺杆344的螺纹远侧端部346沿着植入物10的横向端部可螺纹连接地固定至进入端口或开口50。此外,外部长形构件的突部或翼部314可接合植入物10的对应的凹处28。或者替代于此公开的匹配或接合特征或构件或除其以外,插入工具组件300和植入物10可包括一个或更多个其它类型的对应的匹配或接合特征或构件。
一旦已将植入物恰当地固定至插入工具组件300的远侧端部,外科医生或其它临床医生可将植入物10驱动到目标椎间空间中。在一些实施方式中,通过利用冲锤组件380、槌棒或任何其它工具或器械撞击组件300的近侧端部,可将插入工具组件300推进到骨骼中(例如,抵抗任一阻力)。可在实时显影下执行该植入过程,以确保恰当地推进和放置该植入物。
于此公开的插入工具组件300的包括外部长形构件310、螺杆340和锤垫360在内的多种部件可包括一种或更多种刚性材料,例如,硬化不锈钢、其它类型或级别的钢、钛、其它金属或合金、复合材料、其它天然或合成材料和/或其它类似的材料。如所期望或所要求的那样,这种部件可以是可重复使用的(例如,可消毒的)或一次性的。
植入物的填充
一旦已将植入物恰当地放置在目标椎间空间内,就可利用一种或更多种移植材料、其它填充材料和/或类似的填充材料来至少部分地填充该植入物的内腔。例如,可被输送至植入物的内腔的多种材料包括但不限于成骨细胞、脱钙骨基质(DBM)、骨形态发生蛋白(BMP)、胶原基质、骨接合剂、其它可流动的移植剂或材料、片状的或其它非流动的移植剂或材料、其它生物的或非生物的材料或物质和/或其它移植材料或填充材料。
如于此所指出的那样,在一些实施方式中,在植入之前,利用一种或更多种移植剂、其它填料和/或任何其它材料或物品至少部分地预填充该植入物。例如,在一些布置中,在将植入物推进至骨骼内之前,将海绵、泡沫、其它多孔结构或构件或其它吸收性构件放置在植入物的腔内。在已将植入物放置在目标椎间空间内之后,这种吸收性构件可最初包括一种或更多种移植材料和/或可构造成吸收或以其它方式保持被输送到腔中的移植材料。在其它布置中,在植入之前,可将一种或更多种移植材料和/或其它填充材料以固态或部分固态的形式放置在植入物的内腔内。无论在将植入物输送到患者脊柱内之前将什么物品或材料放置在该植入物内,都可将一个或更多个内部尖头74(图2)、其它突出构件和/或其它保持特征用于将这种物品或材料固定地保持在植入物内。如于此所讨论的那样,这种尖头或其它突出构件构造成在容纳在植入物的内腔或腔室内的材料已经至少部分地凝固或固化之后,接合并保持这种材料。
根据一些实施方式,一旦已经恰当地植入该脊柱植入物,就将插入工具组件300(图11和12A)与植入物分离开并且移除该组件300。在一些实施方式中,随后将填充工具组件插入到骨骼中,以便接合该植入物并将移植材料和/或其它类型的材料选择性地输送到植入物的内腔中。这种填充工具组件可包括被确定尺寸、成形并以其它方式适于通过该植入物的一个或更多个端口放置的导管、管、注射器和/或其它管路。如于此更为详细地讨论的那样,这种端口50可与同样用于在将植入物输送至患者的骨骼内期间将植入物固定至输送工具的远侧端部的端口相同。图13中示出了尤其包括填充工具组件610在内的套件600的一个实施方式。
如图13所示,填充套件600可包括一个或更多个下列物品:填充工具组件610、联接件640、注射器组件S、混合盘T、移植材料或其它填充材料G和/或类似材料的容器。如上文中所指出的那样,移植材料和/或其它类型的填充材料可由外科医生或其它临床医生根据所期望或所要求的方案或手术进行选择。可将该混合盘T用以组合、混合、稀释或以其它方式处理将被选择性地传递到植入物内或其附近的多种移植材料和/或其它填充材料。如所期望或所要求的那样,套件600中包括的多种部件可以是一次性的或可重复使用的。由此,这种部件可包括一个或更多个刚性的、半刚性的和/或柔性的材料,其包括金属或合金(例如,不锈钢)、聚合材料、或热塑性材料、橡胶或其它弹性材料、复合材料、其它天然或人工材料和/或类似的材料。
根据一些实施方式,如图13中所示,填充工具组件610包括终止在远侧端部620中的长形管状轴614。该远侧端部620可包括与轴614的内部通道流体连通的排出口616。此外,填充工具组件610的远侧端部620可包括一个或更多个突部或翼部622,这一个或更多个突部或翼部622被确定尺寸、成形并以其它方式构造成接合植入物10的对应的凹处28或其它特征(图1B)。尽管这种突部622、翼部或其它定位特征并不是必需的,但它们可保证在预想后续的填充步骤时,已相对于植入物恰当地放置了填充工具组件。填充工具组件610的近侧端部630可包括手柄。在所描绘的实施方式中,远侧端部630包括多个环形部分。图14中示出了与已被恰当地固定在目标椎间空间内的植入物10对齐并接合的填充工具组件610的一个实施方式。
继续参照图13,可将移植材料或其它填充材料加载到注射器组件S的注射器650中。如所示,注射器650可包括将移植材料和/或其它填充材料放置在其中的筒状部分652。此外,注射器640可包括柱塞658,该柱塞658可被选择性地推进到该筒652内,以有助于将移植材料和/或其它填充材料推离注射器650的远侧出口654。另外,注射器可包括一对抓持构件656,以便于使用期间的处理和操纵。此外,可将一个或更多个机械工具用于协助外科医生或其它临床医生可滑动地移置柱塞或类似的可移动构件。这种注射器/柱塞构造的使用在传递植入物和/或相对稠密的、密度大的、浓缩的、粘性的或其它难以移动的其它填充材料时是特别有用的。
如图13的分解视图中所示,可将排出联接件660用于将注射器650的远侧端部附接至柔性的导管、管子或其它管路670的长度。在一些实施方式中,管子670是内衬有缆线的和/或被以其它方式加固的,以在使用期间减小扭结的可能性。还可使用这种内衬有缆线的管子来确定它在使用期间处于骨骼内的位置,这是由于利用一种或更多种显像技术可使缆线衬里显像。利用一种或更多种类型的连接方法或设备,例如,鲁尔(Luer)连接、螺纹连接、摩擦配合或压入配合连接、其它类型的紧固件、粘合剂和/或其它类似的连接方法或设备,可将该联接件600永久地或可移除地固定至注射器650和/或管子670。图15中示出了完全组装好的注射器组件S的一个实施方式的立体图。
根据一些实施方式,无论将被填充的脊柱植入物的类型如何,注射器组件S的柔性管子或其它管路670和/或其它部件都保持相同的特性。例如,管子670和联接件的长度可在所有的套件600中保持为一致的或大体上是一致的。由此,在一些实施方式中,可将联接件640用于确保将一定量的移植材料和/或填充材料适当地、精确地且持续地输送至该植入物。
如图13中所示,可将联接件640构造成通过其远侧开口642接收并接合填充工具组件610的近侧端部。同样,联接件640可通过其近侧开口644接收并接合注射器组件S的近侧端部。在一些布置中,基于将被填充的脊柱植入物的尺寸和/或类型来选择联接件640。这种构造可有助于确保在移植物填充阶段的初期,将注射器组件的管子、导管或其它管路670的远侧端部恰当地放置在植入物的内腔内。例如,根据一些实施方式,联接件640对于填充较小的(例如,较短的)植入物而言通常是较长的,而对于填充较大的(例如,较长的)植入物而言通常是较短的。可为套件600设置有多个确定成不同尺寸的联接件640,临床医生可(例如,根据将至少被部分地填充的植入物的类型)从其中进行选择。此外,联接件640可包礼品尺寸标识符646,例如,待填充的植入物的长度。
图16A-16C示出了在准备后填充过程是所执行的三个按时间排序的步骤,其中,在植入后,将移植材料和/或其它填充材料输送到脊柱植入物的内部部分内。在图16A中,已将填充工具组件610恰当地固定至植入物10。例如,如上文中所指出的那样,可使沿着填充工具组件610的远侧端部的突部或翼部与植入物的对应的凹处对齐和配合。如所示,可沿着填充工具组件610的近侧端部放置恰当选择的联接件640。在一些布置中,将一个或更多个接合构件或特征放置在联接件640的远侧端部内,以确保已将填充工具组件610的近侧端部恰当地放置在其中。
接着,如图16B的侧视图中所示,将注射器组件S插入到联接件640和填充工具组件610内并使其相对于联接件640和填充工具组件610推进(例如,在大体由箭头A所呈现的方向中)。图16C示出了相对于联接件640被推进至其完全远侧位置的注射器组件S。因此,在一些实施方式中,如果使用被适当地确定尺寸的联接件640,则应当将管子的远侧端部恰当地放置在植入物10的腔内。因此,该联接件协助外科医生将管路或其它管子的远侧端部沿着植入物的特定的纵向位置精确地放置在内腔内。由此,该外科医生可可靠且放心地开始将装载到注射器650中的移植材料和/或其它填充材料注射到植入物10的腔或其它内部部分中。
根据一些后填充布置,该外科医生可根据他或她自身的要求或方案选择将被传递至植入物10的腔的移植材料和/或其它填充材料的所需量。在一些实施方式中,利用注射器上的标记和/或类似的标记,在植入物自身上的对应的印刷文字向临床医生提供各类植入物的最大内部容量。
根据一些实施方式,外科医生或临床医生通过操纵注射器柱塞和/或通过致动有助于柱塞的许多操纵的一些其它的机械设备(例如,手动调节的棘轮、其它机动化设备等),继续将移植材料和/或其它填充材料注射到植入物的内腔中。该外科医生可选择在将移植材料和/或其它填充材料输送至移植物10的同时,缓慢地、或渐增地或持续地缩回柱塞组件S,并由此缩回管子、导管或其它管路的远侧端部。这可有助于并促进移植材料和/或填充材料在内腔内的更为均匀的分布。在一些实施方式中,注射器组件S的注射筒、联接件和/或任何其它的部件包括刻度线或其它标记,以协助临床医生确定在使用期间将管子缩回多少和/或以怎样的速率缩回该管子。
在一些布置中,输送至植入物的移植材料和/或其它填充材料的数量通常超过腔的内部容量。由此,在某些时刻,可预计过量的移植材料和/或其它填充材料G开始从一个或更多个植入物开口60(例如,沿着植入物的前壁设置的开口)排出。这在图17A和17B中缩回的实施方式中示出。如上文中所指出的那样,在一些实施方式中,植入物的后壁不包括任何开口。此外,也可在植入物的上部界面和/或下部界面以及相邻的椎骨终板表面处引导过量的移植材料和/或其它填充材料。根据一些布置,如于此所讨论的那样,沿着植入物的上表面和/或下表面的齿部或其它接合构件的方位可有助于防止或减少过量的移植材料和/或其它填充材料穿过植入物—终板界面的流动的可能性和/或减缓该流动的流速。
根据一些实施方式,过量的移植材料和/或其它填充材料G可大体地填充存在于椎骨终板与植入物的相邻表面之间的任何间隙。这可导致改良的脊柱融合。此外,脊柱融合可受益于通过开口60沿着植入物10的前壁离开的过量的移植材料和/或其它填充材料。如图17A和17B的实施方式中所描绘的那样,这种材料G可填充沿着脊柱的前端的存在于植入物与残留的椎间盘材料和/或其它组织之间的任何间隙。例如,过量的移植材料和/或其它填充材料G可至少部分地覆盖植入物的前表面、可横越沿着植入物的前侧的相邻椎骨V终板之间的竖向间隙和/或可使其它部分沿着植入物的前端和/或横向端迁移以帮助改进融合。如上文中所指出的那样,可消除沿着植入物的后壁的类似的开口,以便防止或减少过量的移植材料和/或其它填充材料迁移至患者脊柱的神经根、脊髓和/或其它敏感区域的可能性。
根据一些实施方式,如图18的局部横截面视图中所示,插入工具组件300’的螺杆340’可为管状的。由此,可将该插入工具300’用于将植入物输送至其恰当的椎间位置并用于随后以一种或更多种移植材料和/或其它填充材料填充植入物10的内腔。例如,在所描绘的布置中,管状的螺杆340’的内部通道341’可被确定尺寸、成形并以其它方式构造成接收注射器组件的柔性管、导管或其它管路。因此,可消除对于使植入物10与插入工具组件300’的远侧端部脱离接合并接合单独的填充工具组件(如于此参照若干实施方式所讨论的那样)的需要。作为替代,插入工具组件300’可保持成在将填充管或其它管路插入到管状螺杆340’的内部通道341’内的同时接合于植入物10。一旦已将所期望或所要求量的移植剂和/或其它填充材料传递至植入物,就可将填充管路和插入工具组件从患者骨骼上移除。在一些实施方式中,锤板或撞击板360(图12A)可包括对应的开口,管子可穿过该开口被传送以到达管状杆340’的通道341’。因此,与插入工具和/或填充组件的任何其它部件的情况一样,管状杆340’可以是一次性的。
如就于此公开的若干实施方式所讨论的那样,脊柱融合过程可包括最初的植入物输送步骤,继之以后续填充步骤。由此,在一些实施方式中,将植入物输送到患者的骨骼内,该植入物的内腔或腔室或者是空的或者仅部分地填充有移植剂、其它填充材料和/或其它部件。例如,如上文中所讨论的那样,在将植入物输送到目标椎间空间内之前,植入物可包括多孔泡沫、海绵和/或一种或更多种其它吸收性设备或材料。在这种实施方式中,在输送植入物之前或期间,植入物内没有其它材料(例如,移植剂、其它填充材料等)。在其它布置中,在将植入物输送至目标椎体间空间之前或期间,植入物的内腔或其它腔室仅部分地填充有移植材料和/或其它填充材料。
根据于此公开的多种实施方式和示例,可在植入过程之后,将一种或更多种生物的和/或非生物的移植材料和/或其它填充材料注入或以其它方式输送到植入物内或其附近。这种过程可有助于确保移植材料和/或其它填充材料在将植入物输送至患者体内期间不会损失(例如,由于在这种输送方案期间施加在植入物上的捶击或其它冲击力)。此外,如于此所讨论的那样,通过将过量的填充材料输送至植入物内或其附近,可有利地提供植入物至相邻的脊柱表面(例如,终板表面)的更为增强的融合。
图19-21中示出了脊柱植入物1100的另一实施方式。如所示,植入物1100可包括顶部表面1112和底部表面1114,该顶部表面1112和底部表面1114具有构造成接合患者的椎骨构件的对应部分(例如,相邻的终板表面)的一个或更多个齿部1122和/或其它特征。另外,如于此参照其它实施方式所讨论的那样,所示植入物1100包括一个或更多个前部孔或开口1134a、1134b,过量的移植材料和/或其它填充材料可通过该一个或更多个前部孔或开口1134a、1134b离开植入物1100的内腔或腔室1116a、1116b。另外,在一些实施方式中,植入物的后壁不包括任何开口,从而防止或减少了过量的移植材料和/或其它填充材料将在那个方向中移动的可能性。
继续参照图19和20,与于此公开的任何实施方式一样,植入物1100可包括将内腔或腔室划分为两个或更多个区域的一个或更多个内部壁或隔壁1132。在一些实施方式中,这种单独的内腔、腔室或区域1116a、1116b可经由内部壁或隔壁1132内的一个或更多个开口1134或其它孔口彼此流体连通。然而,在一些实施方式中,植入物并不包括任何内部壁或隔壁。由此,植入物可包括仅仅单个相对大的内腔或腔室,同时保持所需要的载荷支承能力和其它结构设计标准。
与于此公开的其它实施方式一样,植入物1100可有利地被确定尺寸、成形并以其它方式构造成横越或延伸遍及下部椎骨构件和上部椎骨构件的整个或几乎整个宽度,其中,将植入物1100放置并固定在该下部椎骨构件与该上部椎骨构件之间。此外,植入物1100的横向端1118、1120可包括相对大的壁,这些相对大的壁与相邻的椎骨构件的承载部分大致重合(例如,参见图7A和21)。
如于此就其它植入物布置所注意到的那样,所示植入物1100可包括沿着植入物的一个或更多个表面的一个或更多个端口1136。例如,如图19-21中所示,可沿着植入物1100的横向侧壁中之一设置单个端口1136。如于此更为详细地讨论的那样,这种端口1136可构造成接收植入物输送工具(例如,以协助外科医生将该植入物经患者的骨骼移动至目标椎间空间)和/或传递一个或多个填充管或管路,用于利用移植剂和/或其它填充材料至少部分地后填充植入物的内腔或腔室。在于此公开的任何植入物实施方式或其等效方式中,可适用于与植入物定位和移植物输送相关的双重目的相关的这种端口可沿着植入物的任何侧壁(例如,横向壁、前壁、后壁)设置。
另外,如图20中所示,可将盖罩或其它密封构件1138固定至端口1136。这种盖罩1138可有助于确保被输送或以其它方式放置在植入物的内部内的移植材料和/或填充材料不会通过端口1136逸出。在其它实施方式中,该端口可包括一个或更多个阀或其它流体阻塞构件,以有助于减少材料从植入物的内部不经意的逸出。
参照图21的侧向横截面视图,植入物端口可被确定尺寸、成形并以其它方式构造成接收填充管或其它管路1200。这种填充管1200可穿过端口并进入到植入物1100的一个或更多个内腔或其它腔室。如所示,填充管1200的远侧端部1220可完成一定角度以使得出口1212定向成大致垂直于端口和填充管1200的轴线A。在其它实施方式中,如所期望或所要求的那样,出口1212的正面可沿着不同的角度(例如,相对于纵向轴线A处于0度至90度之间)定向。在一些实施方式中,可将柱塞组件1206放置在填充管内或者可操作性地联接至该填充管。因此,可选择性地致动这种柱塞组件1206,以便提供所必需的驱动力以将移植材料G移动通过管1200并移动到植入物的内部区域中。
根据一些实施方式,如图21中所示,脊柱植入物的顶部表面和/或底部表面可以是大致弯曲的或圆形的。在这种布置中,顶部表面和/或底部表面的曲率可构造成与患者的相邻的终板E或其它的自然组织的形状相匹配或大体地对齐。然而,如上文中参照图1A和1B中所示的植入物实施方式所讨论的那样,该顶部表面和/或底部表面可以是大致平面的。
为了有助于说明所公开的实施方式,已在上文中将诸如向上、上部、底部、向下、下部、后部、前部、竖向的、水平的、上游的、下游的之类的词语用于描述不同的实施方式和/或附图。然而,将会理解到的是,无论是否示出,均可将不同的实施方式设置和定向在多种所需要的位置中。
尽管已经在某些具体实施方式和示例中公开了在本申请中所提供的主题,但所属领域技术人员将会理解的是,在本申请中所公开的发明将具体公开的实施方式扩展至其它替代实施方式和/或于此公开的主题的用途和明显的变型以及其等效实施方式。另外,尽管已经详细地示出并说明了本发明的多种变型方案,但是对于所属领域技术人员而言,基于本公开内容,这些发明的范围内的其它变型将变得明显。同样设想到的是,可对实施方式的具体特征和方面进行多种组合或子组合,并且这些组合或子组合仍然落在于此公开的本发明的范围内。因此,应当理解的是,所公开的实施方式的多种特征和方面可彼此组合或进行替代,以便形成所公开的发明的各不相同的模式。由此,意图是本申请中提供的主题的范围不应当受到在上文中所述的所公开的具体实施方式的限制,但应当仅仅通过对所附权利要求进行的合理阅读所确定。

Claims (44)

1.一种脊柱植入物,所述脊柱植入物构造成用于放置在患者的椎间空间内,所述脊柱植入物包括:
前壁和后壁,所述后壁与所述前壁大致相对;
第一横向壁和第二横向壁,所述第一横向壁和所述第二横向壁构造成在所述前壁与所述后壁之间延伸;
至少一个内腔,所述至少一个内腔至少部分地被所述前壁、所述后壁以及所述第一横向壁和所述第二横向壁限定;
顶部表面,所述顶部表面包括多个齿部,所述顶部表面的多个齿部构造成至少部分地接合第一椎骨体的下表面;
底部表面,所述底部表面包括多个齿部,所述底部表面的多个齿部构造成至少部分地接合第二椎骨体的上表面,所述第二椎骨体与所述第一椎骨体相邻;
其中,所述至少一个内腔至少部分地从所述植入物的所述顶部表面延伸至所述植入物的所述底部表面;
至少一个开口,所述至少一个开口延伸通过所述前壁,所述至少一个开口与所述至少一个内腔流体连通;
至少一个进入端口,所述至少一个进入端口设置在所述前壁、所述第一横向壁和所述第二横向壁中的至少一个中,其中,所述植入物构造成在所述至少一个进入端口处可释放地固定至插入工具;
其中,所述植入物构造成横越相邻的所述第一椎骨体和所述第二椎骨体的整个宽度;
其中,所述至少一个进入端口构造成接收输送到所述至少一个内腔中的至少一种移植材料;并且
其中,所述后壁不包括任何开口。
2.根据权利要求1所述的脊柱植入物,其中,通过所述至少一个进入端口输送到所述至少一个内腔中的过量的移植材料构造成经所述前壁的所述至少一个开口离开所述植入物。
3.根据权利要求1所述的脊柱植入物,其中,所述进入端口带有螺纹,使得能够将包括对应的螺纹样式的输送工具选择性地附接至所述脊柱植入物以及从所述脊柱植入物上拆下。
4.根据权利要求1所述的脊柱植入物,其中,所述植入物包括至少一个凹处,所述至少一个凹处构造成与植入物输送工具上的对应的突出构件相匹配。
5.根据权利要求1所述的脊柱植入物,其中,所述第一横向壁和所述第二横向壁中的每个均构造成与相邻的所述椎骨体的外围支承区域大致对齐。
6.根据权利要求1所述的脊柱植入物,其中,沿着所述植入物的所述顶部表面和所述底部表面的所述多个齿部构造成朝向所述植入物的横向中心倾斜。
7.根据权利要求6所述的脊柱植入物,其中,倾斜的所述齿部有助于在植入之后将所述植入物保持在目标椎间空间内,并且有助于减少移植材料沿着所述顶部表面和所述底部表面离开所述植入物的所述至少一个内腔的迁移。
8.根据权利要求1所述的脊柱植入物,其中,所述第一横向壁和所述第二横向壁中的至少一个包括锥形部分,以便于所述植入物插入到所述椎间空间中。
9.根据权利要求1所述的脊柱植入物,还包括多个尖头,所述多个尖头延伸到所述至少一个内腔中,用于保持放置在其中的移植物或其它构件。
10.根据权利要求9所述的脊柱植入物,其中,所述多个尖头构造成将海绵、多孔泡沫和固化的移植材料中的至少一种保持在所述植入物的所述至少一个内腔内。
11.根据权利要求1所述的脊柱植入物,其中,所述植入物构造成放置在患者脊柱的腰部或胸部部分内。
12.根据权利要求1所述的脊柱植入物,其中,所述植入物构造成横向插入到所述椎间空间中。
13.根据权利要求1所述的脊柱植入物,其中,所述植入物包括聚醚醚酮(PEEK)。
14.根据权利要求1所述的脊柱植入物,其中,所述第一横向壁和所述第二横向壁中的每一个的长度为所述植入物的整个长度的约10%至20%。
15.根据权利要求1所述的脊柱植入物,其中,沿着所述植入物的所述顶部表面和所述底部表面中的至少一个的所述多个齿部至少部分地以同心的方式定向。
16.根据权利要求1所述的脊柱植入物,其中,沿着所述植入物的所述顶部表面和所述底部表面中的至少一个的所述齿部的曲率半径随着与所述植入物的中心相距的距离的增大而增大。
17.根据权利要求1所述的脊柱植入物,其中,所述植入物的所述顶部表面和所述底部表面中的至少一个为大致平面的。
18.根据权利要求1所述的脊柱植入物,其中,所述植入物的所述顶部表面和所述底部表面中的至少一个为大致弯曲的。
19.根据权利要求1所述的脊柱植入物,其中,所述植入物包括脊柱前凸的植入物,使得所述第一横向壁的高度大于所述第二横向壁的高度。
20.根据权利要求1所述的脊柱植入物,其中,所述至少一个内腔不包括任何内部壁或隔壁。
21.根据权利要求1所述的脊柱植入物,其中,所述至少一个内腔包括由至少一个内部壁或隔壁分开的至少两个内部子腔。
22.根据权利要求1所述的脊柱植入物,其中,所述植入物包括至少一个不透射线的标记。
23.根据权利要求1所述的脊柱植入物,其中,所述至少一个进入端口为大致圆形的。
24.根据权利要求1所述的脊柱植入物,其中,所述至少一个进入端口包括约6mm的最小直径。
25.根据权利要求1所述的脊柱植入物,其中,所述至少一个进入端口适于接收通过其中的填充管路,所述填充管路构造成选择性地将移植材料或填充材料输送到所述植入物的所述至少一个内腔中。
26.根据权利要求1所述的脊柱植入物,其中,所述至少一个进入端口的直径与穿设有所述至少一个进入端口的所述第一横向壁或第二横向壁的高度的比率处于约0.4与0.8之间。
27.根据权利要求1所述的脊柱植入物,其中,所述至少一个进入端口的直径与穿设有所述至少一个进入端口的所述第一横向壁或第二横向壁的高度的最小比率为约0.5。
28.根据权利要求1所述的脊柱植入物,其中,所述至少一个进入端口包括阀或其它流体阻塞装置,以有助于将移植材料保持在所述植入物的所述至少一个内腔内。
29.根据权利要求1所述的脊柱植入物,其中,所述前壁的外部轮廓为大致弯曲的。
30.根据权利要求1所述的脊柱植入物,其中,所述后壁的外部轮廓为大致平面的。
31.一种用于促进脊柱融合的方法,包括:
提供根据前述权利要求中的任一项所述的脊柱植入物;
将所述脊柱植入物放置在患者的两个相邻的椎骨体之间;以及
将至少一种移植材料经所述至少一个进入端口引导到所述脊柱植入物的所述至少一个内腔中;
其中,将输送到所述至少一个内腔中的所述至少一种移植材料的至少一部分构造成在已将足量的所述至少一种移植材料输送到所述至少一个内腔中时经所述前壁的所述至少一个开口离开。
32.根据权利要求31所述的方法,其中,将所述脊柱植入物放置在两个相邻的椎骨体之间包括将所述脊柱植入物可移除地固定至插入工具组件的远侧端部,其中,将所述插入工具组件至少部分地固定至所述脊柱植入物的所述至少一个进入端口。
33.根据权利要求32所述的方法,其中,将至少一种移植材料引导到所述至少一个内腔中包括使所述至少一种移植材料通过所述插入工具组件的管状部分。
34.根据权利要求31所述的方法,其中,将至少一种移植材料引导到所述至少一个内腔中包括使所述至少一种移植材料通过单独的管路,所述单独的管路适于被可移除地放置在所述脊柱植入物的所述至少一个进入端口内。
35.根据权利要求31所述的方法,其中,将至少一种移植材料引导到所述至少一个内腔中包括利用注射器经管子注入所述至少一种移植材料。
36.根据权利要求35所述的方法,其中,将所述管子的路线定为穿过填充管组件的内部通道,所述填充管组件构造成在将所述至少一种移植材料引导到所述植入物的所述至少一个内腔中的同时接合所述脊柱植入物的至少一部分。
37.根据权利要求31所述的方法,其中,将输送到所述至少一个内腔中的所述至少一种移植材料的至少一部分构造成经所述脊柱植入物的上表面与其下表面中的至少一个与椎骨体的相邻终板表面之间的界面离开。
38.根据权利要求31所述的方法,其中,在将所述脊柱植入物放置在所述两个相邻椎骨体之间之前,所述至少一个内腔的至少一部分包括移植材料。
39.根据权利要求38所述的方法,其中,在将所述脊柱植入物放置在所述两个相邻椎骨体之间之后,将附加量的移植材料输送到所述植入物的所述至少一个内腔中。
40.根据权利要求31所述的方法,还包括为所述脊柱植入物的输送准备至少一个相邻的椎骨体表面,其中,所述准备相邻的椎骨体表面包括利用锉磨工具磨擦所述表面。
41.根据权利要求31所述的方法,还包括在将所述脊柱植入物放置在患者的两个相邻的椎骨体之间之前,将定尺寸工具放置在目标椎间空间内,以便确定所述脊柱植入物的适当的尺寸。
42.根据权利要求41所述的方法,其中,将所述定尺寸工具构造成将所述相邻的椎骨体撑开所需要的距离。
43.一种套件,包括:
根据权利要求1-30中的任一项所述的脊柱植入物;
植入物输送工具,所述植入物输送工具构造成可移除地固定至所述脊柱植入物;以及
移植材料输送系统,所述移植材料输送系统构造成将至少一种移植材料选择性地输送至所述脊柱植入物的至少一个内腔中。
44.根据权利要求40所述的套件,其中,所述移植材料输送系统包括构造成通过所述脊柱植入物的至少一个进入端口的管路、定尺寸工具和注射器。
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