CN1756517A - 用于椎体间脊柱稳定的使用可扩张设备的系统和方法 - Google Patents

用于椎体间脊柱稳定的使用可扩张设备的系统和方法 Download PDF

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Publication number
CN1756517A
CN1756517A CNA2003801086349A CN200380108634A CN1756517A CN 1756517 A CN1756517 A CN 1756517A CN A2003801086349 A CNA2003801086349 A CN A2003801086349A CN 200380108634 A CN200380108634 A CN 200380108634A CN 1756517 A CN1756517 A CN 1756517A
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expansible
equipment
expansible equipment
expansion
height
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海·H·德留
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Warsaw Orthopedic Inc
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SDGI Holdings Inc
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    • A61F2250/0036Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
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Abstract

可扩张设备(30)包括一个主体,该主体确定一中空内部(40),用于容纳位于输送装置(50)远端部分的可扩张元件(55)。该可扩张设备在输送装置的远端部分上是塌陷的,用以输送至脊柱盘间隙。在塌陷的可扩张设备输送入脊柱盘间隙的情况下,输送装置的可扩张元件是可扩张的以扩张该可扩张设备和分离盘间隙。在分离后该可扩张设备可保留在脊柱盘间隙内,以稳定毗邻椎骨。

Description

用于椎体间脊柱稳定的使用可扩张设备的系统和方法
相关申请的交叉参考:
本申请要求2002年11月21提交的第60/428,061号临时申请的申请日的权益。
背景
脊椎变形时,由于盘空间的状况或手术期间产生的状况,脊柱的毗邻椎骨间的盘空间高度可能缺乏或异常,在外科手术期间恢复盘空间高度可能需要装置的插入以在植入物植入期间提供和维持盘空间的分离。这类装置的使用需要时间去允许这种插入,以及需要手术部位额外的暴露以容纳该类装置。
已开发了椎体间融合笼,其在插入后具有调整高度的能力。然而,这种调整可能需要操作笼内笨重的和复杂的各装置以调整笼的高度。这种调整也可能导致负荷在椎骨终板上、椎骨终板与各自的笼表面的接触面上的非均一散布。并且,笼内的内部扩张机构减少了笼内可用于骨生长材料的空间。
仍需要最小化外科暴露和脊柱手术期间使用的装置数目的脊柱稳定系统和方法,减少插入稳定装置所需时间,并减少稳定性丧失的可能。
概述
提供了减少椎骨间脊柱稳定的复杂性和侵入性的系统,该系统具有一可用一可扩张输送装置输送至脊柱的盘间隙的可扩张的设备。该可扩张设备在盘间隙内由输送装置的可扩张元件扩张,以分离盘间隙和植入该扩张的设备以提供稳定性。
依据一个方面,提供了一种脊柱植入系统,该系统包含一个可扩张设备和一个输送装置。该输送装置包含一适合于该设备的内腔的大小和形状的远端扩张元件,以在用输送装置将塌陷的可扩张设备输送至外科部位后,对该设备施加扩张力。
依据另一方面,提供了一种脊柱植入系统,该系统包含一个可扩张设备和一个输送装置。该输送装置包含一个球囊形式的远端扩张元件,该球囊是可扩张的以对可扩张设备施加扩张力。
依据另一方面,提供了一种脊柱植入系统,该系统包含一个可扩张设备和一个输送装置。该输送装置在塌陷的可扩张设备内包含一个具有可扩张元件的远端部分,该可扩张元件构型为沿着可扩张设备的长度均一地施加一扩张力,以在原处扩张可扩张设备。
依据再一个方面,提供了一种固定于一输送装置的可扩张部分上的可扩张设备。该可扩张设备具有一非扩张的结构,用于在最小侵入性外科过程中输送至手术部位,以及在其后可由输送装置扩张至一扩张的结构用于在该外科部位的术后植入。
另一个方面考虑了用于在盘间隙内放置一椎体间融合设备的各个方法,其中该椎体间融合设备由输送装置输送和扩张以分离盘间隙。骨填充材料可被放置在扩张的可扩张设备内以便于椎骨间的融合。
另一个方面考虑了用于在盘间隙内放置一椎体间设备的各个方法,其中该椎体间设备由输送装置输送和扩张以分离盘间隙。一弹性核心可被放置在可扩张设备的腔内以维持脊柱的盘间隙的运动。
这些和其它各方面还呈现在下面的描述中。
                        附图简述
图1是依据一实施方案的塌陷的可扩张设备和输送装置的截面图。
图2是处于扩张状况中的图1中的可扩张设备和输送装置。
图3A和3B分别是一个脊柱节段的平面图和正视图,该脊柱节段具有一个准备容纳一对例如图1所示的可扩张设备的椎骨间隙。
图4A和4B分别是平面图和正视图,其中图1的可扩张设备和输送装置显示为截面并放置在脊柱节段准备好的位置内。
图5A和5B分别是平面图和正视图,其中可扩张设备和输送装置显示为截面并在脊柱节段准备好的位置内如图2所示一样扩张。
图6A和6B分别是平面图和正视图,其中图2的扩张的可扩张设备显示为截面并位于脊柱节段准备好的位置内并输送装置已塌陷。
图7A和7B分别是部分截面的平面图和正视图,其中图2的扩张的可扩张设备显示为截面并位于脊柱节段准备好的位置内并输送装置已去除。
图8A和8B分别是一个脊柱节段的平面图和正视图,该脊柱节段具有一个准备容纳一对依据另一实施方案的可扩张设备的椎骨间隙。
图9A和9B分别是部分截面的平面图和正视图,其中另一实施方案的塌陷的可扩张设备和输送装置显示为截面并放置在脊柱节段准备好的位置内。
图10A和10B分别是平面图和正视图,其中扩张的可扩张设备和输送装置显示为截面并位于脊柱节段准备好的位置内。
图11A和11B分别是平面图和正视图,其中扩张的可扩张设备显示为截面并位于脊柱节段准备好的位置内且输送装置已塌陷。
图12A和12B分别是平面图和正视图,其中扩张的可扩张设备显示为截面并位于脊柱节段准备好的位置内且输送装置已去除。
图13是位于脊柱的盘间隙内的图7A和7B的可扩张设备的末端正视图。
图14是位于脊柱的盘间隙内的图12A和12B的可扩张设备的末端正视图。
图15是位于脊柱的盘间隙内的另一实施方案的一对可扩张设备的末端正视图。
图16是位于脊柱的盘间隙内的显示为截面的另一实施方案的可扩张设备的侧面正视图。
图17是一截面图,示出用于插入一个或多个可扩张设备的至一脊柱的盘间隙的通道。
图18是一截面图,示出用于插入一个或多个可扩张设备的至一脊柱的盘间隙的另一通道。
图19是一截面图,示出用于插入一个或多个可扩张设备的至一脊柱的盘间隙的另一通道。
图20是一截面图,示出用于插入一个或多个可扩张设备的至一脊柱的盘间隙的另一通道。
图21是另一实施方案可扩张设备的端视图。
图22是处于非扩张结构中的另一实施方案可扩张设备的透视图。
图23是处于非扩张结构中的另一实施方案可扩张设备的正视图。
图24是处于扩张结构中的图23中的可扩张设备的正视图。
图25是已扩张的图24中的可扩张设备的端视图。
图26是变形的脊柱节段的正视图,该脊柱节段具有一放置在盘间隙内处于非扩张状态的可扩张设备。
图27是图26中的脊柱节段,可扩张植入物在盘间隙内已扩张。
图28是图27中的脊柱节段,第二可扩张植入物在盘间隙内已扩张。
图29是处于非扩张结构中的另一实施方案可扩张设备的正视图。
图30是处于扩张结构中的图29中的可扩张设备的正视图。
图31是图29的非扩张的可扩张设备的端视图,其中具有一输送装置的远端部分。
图32是图31中的可扩张设备和输送装置部分的端视图,输送装置的远端部分和可扩张设备已扩张。
图33是图32中已扩张的可扩张设备的端视图,中介元件放置在其腔内。
图34是图33中已扩张的可扩张设备和中介元件的端视图,可扩张设备呈这样一种形式:允许由该中介元件提供主要支撑。
图35A和35B分别是依据另一实施方案、放置在脊柱节段的塌陷的盘间隙内、显示为截面的塌陷的可扩张设备和输送装置的平面图和正视图。
图36A和36B分别是位于该脊柱节段的恢复的盘间隙内、显示为截面的已扩张的可扩张设备和输送装置的平面图和正视图。
图37A和37B分别是位于该脊柱节段的恢复的盘间隙内、显示为截面的已扩张的可扩张设备的平面图和正视图,且输送装置被去除。
图38A和38B分别是依据另一实施方案、放置在脊柱节段的塌陷的盘间隙内、显示为截面的塌陷的可扩张设备和输送装置的平面图和正视图。
图39A和39B分别是位于该脊柱节段的恢复的盘间隙内、显示为截面的已扩张的可扩张设备和输送装置的平面图和正视图。
图40A和40B分别是位于该脊柱节段的恢复的盘间隙内、显示为截面的已扩张的可扩张设备的平面图和正视图,且输送装置被去除。
图41A和41B分别是依据另一实施方案、放置在脊柱节段的塌陷的盘间隙内、显示为截面的塌陷的可扩张设备和输送装置的平面图和正视图。
图42A和42B分别是位于该脊柱节段的恢复的盘间隙内、显示为截面的已扩张的可扩张设备和输送装置的平面图和正视图。
图43A和43B分别是位于该脊柱节段的恢复的盘间隙内、显示为截面的已扩张的可扩张设备的平面图和正视图,且输送装置被去除。
图44A和44B分别是依据另一实施方案、放置在脊柱节段的塌陷的盘间隙内、显示为截面的塌陷的可扩张设备和输送装置的平面图和正视图。
图45A和45B分别是位于该脊柱节段的恢复的盘间隙内、显示为截面的已扩张的可扩张设备和输送装置的平面图和正视图。
图46A和46B分别是位于该脊柱节段的恢复的盘间隙内、显示为截面的已扩张的可扩张设备的平面图和正视图,且输送装置被去除。
图47A和47B分别是一输送装置当远端可扩张元件处于非扩张状态和扩张状态时的正视图。
图48A和48B分别是依据另一实施方案、放置在脊柱节段的塌陷的盘间隙内、显示为截面的塌陷的可扩张设备和输送装置的平面图和正视图。
图49A和49B分别是位于该脊柱节段的恢复的盘间隙内、显示为截面的已扩张的可扩张设备和输送装置的平面图和正视图。
图50A和50B分别是位于该脊柱节段的恢复的盘间隙内、显示为截面的已扩张的可扩张设备的平面图和正视图,且输送装置被去除。
                            图解实施方案的描述
为了促进对本发明原理的理解,现提及并使用专门语言描述附图中图解的实施方案。无论如何应明确并不因此限制本发明的范围,本发明相关领域的技术人员通常会做的对所阐述的设备的任何类似的代替和进一步改进以及类似于这里阐述的任何本发明原理的进一步应用已被考虑到。
已具有用于在一脊柱节段的骨结构之内和之间放置和展开可扩张设备的系统和方法。这样的系统可包含将该可扩张设备输送至手术部位并在该位置扩张该可扩张设备的装置。当放置在一椎骨间隙时,这样的扩张可分离毗邻的椎骨、恢复变形的脊柱节段、并提供一个或更多骨结构的直接和长期的支撑。
依据一个实施方案,该输送装置包含一个具有一可扩张远端部分的球囊导管型装置,一个塌陷的可扩张设备围绕该可扩张的远端部分放置和固定以输送至手术部位。该输送装置可在最小侵入性外科过程中被采用以将该塌陷的或非扩张的可扩张设备输送至手术部位。紧接着该可扩张设备在手术部位的放置,该输送装置的远端部分可扩张以在手术部位展开和扩张该可扩张设备。当放置在一椎骨间隙时,可扩张设备的这种展开和扩张能够,例如,分离毗邻的椎骨以提供理想的盘间隙高度。
该系统和方法可在至脊柱的最小侵入性外科通路中被采用。这样的通路包含前方的、后方的、经椎孔的、侧方的、斜的、经椎弓根的、以及至盘间隙的其它通路。这些通路在自然状态下可以是单一入口或多个入口的。该通路可至脊柱节段的任何部分,包含骶、腰、胸和颈区。使用该可扩张设备的扩张分离盘间隙去除了在该可扩张设备插入前在该盘间隙内放置一分离设备以维持盘间隙分离的需要。该系统和方法可以和任何检视系统一起使用以协助监测可扩张设备在盘间隙的放置和该设备由分离装置的扩张。合适的检视系统的例子包含荧光镜、内镜、显微镜、CT扫描、X-射线和肉眼观察系统。
现参考图1和2,示出一个可扩张设备30的第一实施方案。在该实施方案中,可扩张设备30包含一个可放置在脊柱的盘间隙内的延长的主体,该主体包含一个可沿第一椎骨的一个终板放置的第一部分34,和一个可沿毗邻的第二椎骨的终板放置的第二部分44。第一部分34在远端引导插入端36和近端跟随端32之间延伸。第二部分44在远端引导插入端46和近端跟随端42之间延伸。在第一部分34和第二部分44之间确定一空腔40。空腔40可开口于远端36和跟随端32并在之间延伸。
第一部分34可具有许多啮合元件38,第二部分44也可具有许多啮合元件48。啮合元件38、48可与椎骨的骨组织啮合,可以是例如齿、长钉、隆脊、螺纹、倒钩、刻痕、凸起、毛刺和它们的组合的形式。进一步考虑了外表面可以是光滑的,或辅助固定的或具有啮合元件。第一和第二部分34、44可进一步分别包含一个或更多开口39、49,以便于骨向内生长。
第一部分34和第二部分44可从一非扩张结构,如图1所示,彼此移开至一扩张的结构,如图2所示。在非扩张的结构中,可扩张设备30在第一部分34和第二部分44之间具有如图1所示的高度H1。在扩张的结构中,可扩张设备30在第一部分34和第二部分44之间具有高度H2。考虑了高度H1使可扩张设备30能够被插入,例如,毗邻的椎体之间塌陷或否则变形的盘间隙内。高度H2可对应于提供一理想的毗邻椎骨间盘间隙高度所需的第一和第二部分34、44之间的间隔高度。
可提供一输送装置50以将可扩张设备30由它的非扩张结构改变为它的扩张结构。输送装置50包含一近端轴52和一包含一可扩张元件55的远端部分54。在图示说明的实施方案中,可扩张元件55是一个可膨胀的球囊样结构,其具有如图1所示的塌陷的结构,和如图2所示的扩大的膨胀的结构。轴52可具有一个腔,可通过该腔从开口56为可扩张元件55的内腔57供给液体或材料以扩大或膨胀可扩张元件55。可扩张元件55可放置在可扩张设备30的腔40内,且可扩张元件55和可扩张设备30均处于非扩张或塌陷结构。
当可扩张设备输送到手术部位后,可扩张元件55可被膨胀以给可扩张元件55提供扩大的结构,这样即分开可扩张设备30的第一和第二部分34、44,如图2所示。当可扩张设备30被扩张时,第一部分34和第二部分44彼此移开,和腔40的容积增大。该扩张可分离毗邻的椎骨以在毗邻的终板之间提供理想的间距和恢复盘间隙的高度。
合适的输送装置50的一个例子包含一个高压球囊导管。轴52可以是刚性的、半刚性的或柔性的。轴52可由金属、聚合体、或其组合制造。轴52可具有至少一个腔以使可扩张元件55可被生物相容性液体,如空气或盐水膨胀或扩大。其它实施方案考虑了轴52包含多个腔以,例如,输送骨移植物、骨生长材料、或其它合适的填充材料进入扩张的设备30的扩张的腔40内。考虑了可扩张元件55在填充材料的放置之前或同时是塌陷的。
在图示说明的实施方案中,远端部分54包含一单一的可扩张元件55,虽然也考虑了多个可扩张元件以为远端部分54提供可选择的扩张性能。例如,远端部分54可包含具有不同高度的一远端可扩张元件和一近端可扩张元件以使可扩张设备30的扩张的第一和第二部分34、44之间具有角度。在另一例子中,远端部分54可包含可被选择性扩张的一上方可扩张元件和一下方可扩张元件,以移动第一和第二部分34、44中毗邻的一个而第一和第二部分中的另一个仍保持静止。在再一个例子中,可扩张元件55单方向扩张以在扩张的方向上移动第一和第二部分34、44中毗邻的一个。
在另一实施方案中,考虑远端部分54在扩张后可由轴52切断,并在术后保持可扩张设备30于扩张状态。相应地,可扩张元件55可被骨生长材料或其它合适的骨填充材料扩张以便于骨的生长和通过扩张的设备30保持椎间隙的活动。当填充材料在可扩张元件55内适当地变硬以防止从其中延伸流动,轴52可被去除。代替地或另外地,毗邻可扩张设备55可提供一个阀门设备以阻止填充材料从其中退出。可扩张元件55可由多孔材料、可再吸收材料、或其它合适的材料制造以允许穿过扩张的设备的腔的骨生长。在再一个实施方案中,可扩张设备55由一聚合物膨胀,该聚合物可流进可扩张元件并在此后聚合以在第一和第二部分34、44之间形成一弹性核心。
可扩张元件55可包含与处于扩张结构的腔40的大小和形状相匹配的大小和形状。处于扩张的结构,可扩张元件55可沿第一部分34的内壁表面在引导端36和跟随端32之间实施均匀的扩张力。如果如图2所示被构造为用于双向扩张,可扩张元件55可沿第二部分44在引导端46和跟随端42之间实施均匀的扩张力。该均匀的扩张力沿着毗邻的椎骨终板分散分离负荷以沿着可扩张设备30的长度提供均匀的分离。可扩张元件55和/或腔40可具有任何合适的总体形状包含圆锥形、截头圆锥形、球形、立方体形、球形、多角形、卵形、长圆锥形、长球形、矩形、锥形、阶梯形、狗骨形、分支形和其中的组合。
可扩张元件55可由任何能经受住为原位扩张或膨胀可扩张元件55而供给的压力的合适的材料制成。各例子包含各种聚合物材料,包含聚乙烯、对苯二酸酯、聚烯烃、聚亚安酯、尼龙、聚氯乙烯、硅或其它适合的材料。组成可扩张元件55的材料可被编织或非编织的织物材料加固。合适的加固材料的例子包含那些本质上是聚合物的或金属的材料。
现参考图3A至7B,讨论在一椎间隙内使用可扩张设备和输送装置的外科技术的一个实施例。现参考图3A和3B,示出一个脊柱节段,该脊柱节段包含一具有一下方终板E1的下方椎骨V1,一具有一上方终板E2的椎骨V2,以及其间一未分离的盘间隙D。在适当的椎间盘切除术和终板准备后,该未分离的盘间隙包含插入位置60、160用于容纳可扩张设备。插入位置60包含形成于终板E1内的容纳底座64和形成于终板E2内的容纳底座62,底座通过铰削、敲碎(scraping)、切除或砍凿中的任何一种或其组合形成。
容纳底座62、64可被制成大小和形状匹配将放置在其中的可扩张设备的部分的外表面形状。类似的,插入位置160可包含一个形成于终板E1内的容纳底座164和形成于终板E2内的容纳底座162,底座通过铰削、敲碎、切除或砍凿中的任何一种或其组合形成。容纳底座162、164可被制成大小和形状匹配将放置在其中的可扩张设备的部分的外表面形状。在图解说明的实施方案中,容纳底座62、64、162、164具有一半圆形截面以容纳一具有圆形或弓形截面的可扩张设备。也考虑了其它形状,包含用于容纳底座的矩形和正方形截面。还进一步考虑了不形成容纳底座,以及植入物放置为直接接触终板的皮质骨或另外准备过的终板。
如图4A和4B所示,非扩张的可扩张设备30、130连接于输送装置50、150的塌陷的可扩张元件54、154以输送至手术部位。然后可扩张设备30、130被放置进入未分离的盘间隙D内准备好的插入位置60、160内。一种放射对比液体、盐溶液、压缩空气、或其它合适的液体或物质可通过一可操纵的注射器或泵被输送至可扩张元件55、155以为毗邻椎骨的分离提供足够的压力。随着各自的可扩张元件55、155的压力和容积增加,可扩张设备30、130逐渐被扩张。可扩张设备30、130的第一和第二部分的表面分别与准备好的终板位置62、64和终板位置162、164相接触。可扩张元件55、155内的压力持续增加以膨胀或增大可扩张元件55、155和扩张可扩张设备30、130,直到如图5A和5B所示达到理想的盘间隙D1。因此,在塌陷的可扩张设备30、130插入前分离未分离的盘间隙D并非必要。
然后可扩张元件55、155缩小或塌陷,如图6A和6B所示。然后可扩张元件55、155可从它们各自的已扩张的可扩张设备30、130移开,如图7A和7B所示。填充材料可被堆积、塞满、放置、输送或注射进入扩张的可扩张设备30、130的腔40、140内和/或已分离的盘间隙D1内以促进融合和对毗邻各椎体的长期的支撑。
任何合适的成骨性的材料或组分被考虑用于填充材料,包含自体移植物、异体移植物、异种移植物、去矿物质的骨和合成的和天然的骨移植物替代品,例如生物陶瓷和聚合物和骨诱导性因子。在此应用的术语成骨性材料或成骨性组分广泛的包含任何促进骨生长或愈合的材料包含自体移植物、异体移植物、异种移植物、骨移植物替代品和天然的和合成的和重组的蛋白、激素和同类的物质。
自体移植物可使用钻、圆凿、刮匙和环锯和其它该领域外科医生熟知的工具和方法从例如髂嵴的部位获得。优选地,移植物从髂嵴使用最小侵入性供体外科手术获得。该成骨性材料也可包含骨准备终板时被外科医生刮削掉的骨。
代替骨的结构和功能的天然的和合成的移植物替代物也被考虑用于成骨性组分。任何这样的移植物替代物已被考虑,包含例如,去矿物质的骨基质、带有骨片的去矿物质的骨基质、PMMA和其它可注射的合成的骨粘合剂、矿物质组分和生物陶瓷。一个生物陶瓷材料的大范围的集合,包含本领域公知的能够被使用以有利于该目的的BIOGLASS、羟磷灰石和磷酸钙合成物。优选的钙合成物包含生物活性玻璃、磷酸三钙和羟磷灰石。在一个实施方案中,该移植物替代物是一种包含磷酸三钙和羟磷灰石的双相的磷酸钙陶瓷。
在一些实施方案中,所使用的成骨性组分可包含一种在治疗上有效的数量的刺激或诱导骨生长的骨诱导剂或生长因子或蛋白,该骨诱导剂或生长因子或蛋白位于制药上可接受的载体内的。考虑了重组的人骨形态发生蛋白(rhBMP)的骨诱导性因子,因为它们易于得到并且不引起感染性疾病的传播。该骨形态发生蛋白可以是rhBMP-2、rhBMP-4或它们的异源二聚体。然而,任何骨形态发生蛋白包含设计为BMP-1到BMP-13的骨形态发生蛋白已被考虑。
用于成骨性组分的载体材料的选择基于生物相容性、生物降解能力、机械性能和接触面性能以及可扩张设备的结构。可能的载体包含硫酸钙、聚乳酸、聚酐、胶原、磷酸钙、聚合的丙烯酸酯和去矿物质的骨。该载体可以是能够输送蛋白的任何合适的载体。该载体可以是能被完全吸收入身体,例如一种由Integra LifeSciences公司出售的商品名为Helistat可吸收胶原止血剂的可吸收的胶原海绵。另一载体是一种双相磷酸钙陶瓷。陶瓷块可从Sofamor Danek Group,B.P.4-62180 Rang-du-Fliers,法国,和Bioland,132 Roud Espangne,31100 Toulouse,法国买到。成骨性因子可以任何适合的方式引入载体中。例如,载体可被浸入包含该因子的溶液中。一个优选的实施方案考虑使用Regeneration Technologies,Inc出售的OSTEOFIL异体移植物糊。该异体移植物糊可被从切割手术获得的局部自体移植物补充。
在图3A至7B的实施方案中,可扩张设备30、130可分别被输送装置50、150放射状扩张。考虑了可扩张设备30、130之一可被插入合适的盘间隙位置,然后被扩张以分离椎骨V1和V2。然后另一个可扩张设备被输送至另一插入位置,以及然后被扩张至至少接触椎骨V1和V2的终板。考虑了相同的输送装置50或150可用于输送和扩张每一设备。可选择地,每一可扩张设备30、130可被提前连接至单独的输送装置50、150。通过输送装置50、150之一位于一个已输送和扩张的设备30、130内而另一个可扩张设备30、130被输送和在另一盘间隙位置扩张,可以保持盘间隙D1的分离。
现参考图8A至12B,示出用于输送和在一椎间隙内扩张可扩张设备的系统和技术的另一实施方案。在图8A和8B中,示出一个脊柱节段,该脊柱节段包含具有终板E1的下方椎骨V1、具有终板E2的上方椎骨V2、和其间未分离的盘间隙D。在适当的椎间盘切除术和终板准备后,该未分离的盘空间包含插入位置260、360用于容纳可扩扎设备。插入位置260可包含形成于终板E1内的容纳底座264和形成于终板E2内的容纳底座262,底座通过如下方式中的任何一种或其组合形成:从该终板铰削、敲碎、切除或砍凿骨材料。类似的,插入位置360可包含一个形成于终板E1内的容纳底座364和形成于终板E2内的容纳底座362,底座通过铰削、敲碎、切除或砍凿中的任何一种或其组合形成。容纳底座362、364可被制成大小和形状匹配将放置在其中的可扩张设备的部分的外表面形状。在该图解的实施方案中,容纳底座262、264、362、364被构成为具有矩形截面以容纳一放置其中的可扩张设备的被对应地成形的部分。
如图9A和9B所示,可扩张设备230、330分别沿着输送装置250、350的远端部分254、354连接于塌陷的可扩张元件255、355。然后可扩张设备230、330在未分离的盘间隙D内被放置进入相应的插入位置260、360内。一种放射对比液体、盐溶液、压缩空气、或其它合适的液体或物质可通过一可操纵的注射器或泵通过轴252、352被输送至可扩张元件255、355以为扩张可扩张设备230、330提供足够的压力和在该扩张期间分离毗邻的椎骨。随着各自的可扩张元件255、355的压力和容积增加,可扩张设备230、330逐渐被扩张,这样第一和第二部分朝向各自的椎骨V1和V2彼此移开。可扩张设备230、330在毗邻的椎骨之间在垂直方向上基本是双向可扩张的或单向可扩张的。
可扩张设备230的第一和第二部分的表面与准备好的终板位置262、264相接触,和可扩张设备330的第一和第二部分的表面与终板位置362、364相接触。可扩张元件255、355被增大或膨胀直到如图10A和10B所示达到理想的盘间隙D1。因此,在塌陷的可扩张设备230、330插入前分离未分离的盘间隙D并非必要。
然后可扩张元件255、355缩小或塌陷,如图11A和11B所示。然后远端部分254、354可从它们各自的已扩张的可扩张设备移开,如图12A和12B所示。骨生长促进材料包含骨移植物、骨移植物替代品、骨生长因子/载体、同种异体移植物、自体移植物、治疗性制剂、和其它合适的材料可被堆积、塞满、或注射进入扩张的可扩张设备230、330的各腔内和/或已分离的盘间隙D1内以促进融合和对毗邻各椎体的长期的支撑。附加或代替地,骨粘合剂,包含生物活性骨粘合剂,可被堆积、塞满、或注射进入该可扩张设备的腔内以提供对毗邻椎骨的长期支撑。
考虑了用于可扩张设备的各种截面形状和扩张特性。在图13中,示出位于一脊柱的盘间隙内的可扩张设备30、130具有圆形截面形状。可扩张设备30、130是可放射性地扩张的,这样每一设备的高度上和侧向上的范围由于扩张而增加。在图14中,示出位于一脊柱的盘间隙内的可扩张设备230、330具有一矩形截面形状。可扩张设备230、330是可双向或单向扩张的以垂直增加每一设备的高度而侧向范围保持几乎不变。在图15中,示出位于一脊柱的盘间隙内的可扩张设备400、410具有卵圆形截面形状。可扩张设备400、410是基本上可双向或单向扩张的以垂直增加每一设备的高度而侧向范围轻微扩张或保持几乎不变。也考虑了其它截面形状,包含例如多边形、椭圆和跑道形状。
进一步考虑了可在一椎间隙内放置两个以上可扩张设备,以恢复椎骨间的盘空间高度。还考虑了可在一椎间隙内放置单一的可扩张设备。
考虑了沿着可扩张设备的长度的各种形状。例如,在图16中,示出包含一沿其长度的锥形截面的可扩张设备420。可扩张设备420包含一具有后方末端428和前方末端426的第一部分422。可扩张设备420进一步包含一具有后方末端432和前方末端430的第二部分424。在扩张的状态下,如图16所示,后方末端428、432被放置为彼此较前方末端426、430更靠近。这个位置在可扩张设备420的上方和下方表面之间提供一锥形,当可扩张设备420由腔436内的相应成形的输送装置的远端部分扩张时,该锥形恢复该脊柱节段正常的脊柱前凸曲线。对于正常的脊柱后凸曲线,前方和后方末端之间的相对位置可反转。
为了椎骨间应用,考虑了各种至脊柱的盘间隙的通道。在图17中,使用一前方通道,在其内形成插入位置70、72以容纳一对并排的可扩张设备30、130。其它实施方案考虑一个插入单一的可扩张设备的前方通道,该可扩张设备定大小和形状为双侧支撑毗邻的椎骨。
在图18中,显示了一个后方通道,在该后方通道内植入物容纳位置74、76在盘间隙内在后部形成。可扩张设备30、130以一塌陷的状态从一后方通道插入该植入物容纳位置,此后被扩张以分离盘间隙。通过以一塌陷的状态将可扩张设备30、130插入一后方通道,该通道内收缩至盘间隙的神经根和肌肉的数量被最小化。而且,在盘间隙内不需要单独的分离器或其它设备,该分离器或其它设备将在盘间隙内占据空间,目的是在植入物插入期间保持分离。这样的分离器还可在通向植入物插入位置的解剖空间内占据空间。去除分离器在盘间隙内为已扩张的可扩张设备的占据提供了额外的空间。
在图19中,显示了一个后侧方通道,在该后侧方通道内插入位置78、80在盘间隙内倾斜形成。可扩张设备440、450以一塌陷的状态从一后侧方通道插入该植入物容纳位置,此后被扩张以分离盘间隙。可扩张设备440、450在盘间隙内形成一V形,该V形的尖端指向前方。通过以一塌陷的状态将可扩张设备440、450插入一后侧方通道,该通道沿着该椎骨的后部中心远离脊髓区域移动。并且,在此过程中不需要将被放置在盘间隙内的单独的分离器或其它设备,在盘间隙内为已扩张的可扩张设备的占据提供了额外的空间。
在图20中,显示了一个侧方通道,在该侧方通道内形成侧向彼此隔开穿过盘空间的插入位置82、84。可扩张设备460、470以一塌陷的状态从一侧方通道插入该插入位置,此后被扩张以分离盘间隙。通过以一塌陷的状态将可扩张设备460、470插入一侧方通道,神经根和肌肉收缩的数量和在胸廓过程中肋架的扩张一起被最小化。而且,在盘间隙内不需要单独的分离器或其它设备以保持分离,该分离器或其它设备将在盘间隙内和至盘间隙的通道内占据空间。其它的实施方案考虑了一个侧方通道,在其内插入一单一的可扩张设备,该可扩张设备定大小和形状为提供对毗邻椎骨的前方和后方支撑。
在图20中,在前部放置的可扩张设备460包含一个主体462,该主体462在一引导插入端464和一相对的跟随端466之间延伸。在后部放置的可扩张设备470包含一主体472,该主体472在一引导插入端474和一相对的跟随端476之间延伸。在各自的引导和跟随端之间的主体462的长度可短于主体472的长度,以在盘间隙内容纳可扩张设备460的前部放置。
此处考虑的可扩张设备可以各种形式被提供。例如,如图21所示,可扩张设备的第一和第二部分沿着第一和第二部分交迭的侧壁可以是可调地连接。可扩张设备480包含类似于上述可扩张设备30的一第一部分482和一第二部分492。第一部分432包含相对的侧壁484、485,和第二部分492包含相对的侧壁494、495。第一部分482和第二部分492确定了其间的一个腔488,输送装置50的可扩张元件55可被放置在该腔中。
毗邻的侧壁484、494包含许多啮合彼此的互相交叉的齿,和毗邻的侧壁485、495包含许多啮合彼此的互相交叉的齿。在图解说明的实施方案中,该互相交叉的齿沿侧壁484、485、494、495的长度的全部或部分延伸。该互相交叉的齿可使第一和第二部分482、492紧接着腔488内的可扩张元件55的扩张如箭头490所指示单向或双向彼此移开。该互相交叉的齿可包含一抵抗或阻止第一和第二部分在扩张后朝向彼此移动的棘齿结构。
可扩张设备480在分离后立即保持对分离的椎骨的支撑,即使在从腔488去除可扩张元件55之后。该互相交叉的齿还确定多个第一和第二部分482、492之间的扩张的或分离的位置,该多个扩张的或分离的位置提供可由单个可扩张设备480实现的各分离高度。因此,可扩张设备480在垂直方向上是可塌陷的以便于由输送装置插入一塌陷的盘间隙,和此后在垂直方向上是可扩张的以分离该盘间隙和保持手术后的分离。
在另一实施例中,该可扩张设备可由形状记忆材料或可塑材料制成,该可扩张设备是非扩张的或塌陷的用于在插入前放置在输送装置上。一旦插入脊柱的盘间隙内,该设备可通过输送装置的膨胀或扩大放射状地扩张以呈现和保持一扩张的结构。该可扩张设备的扩张可通过温度变化、化学变化、或由于输送装置50的可扩张元件55膨胀或扩大的力导致的变化而实现。
例如,图22示出可扩张设备530包含一主体538,该主体538确定一在近端534和远端536之间延伸的内腔532。主体538包含多个在其周围的部分542,每一该部分确定一个伸长的弹性开口544。毗邻片段542通过合叶546相互连接。主体538由足够可塑或可成形材料制成,以使一旦施加如箭头540指示的放射状扩张力,弹性开口544可增大和合页546可伸展以允许片段542彼此移开,增大内腔532,从而分离毗邻椎骨。
在另一个实施例中,该可扩张设备可包含第一机械结构,该第一机械结构允许用于使用输送装置插入该设备的塌陷状况。在插入后,紧接输送装置远端部分的膨胀或扩大,该设备可被机械调整以在手术部位呈现一扩张的状况。这样的可扩张设备的例子包含那些由金属丝网制成的,和具有由机械联接连接的第一和第二部分的设备,如图23-25所示。
在图23-25中,设备630包含一第一部分632和一第二部分642。联接650可移动地将第一和第二部分632、642彼此连接。联接650包含可枢转地彼此连接的第一和第二元件652、654。元件652、654每一个都包含一放置在第一部分632的凹槽634中各自的一个内的第一末端,和相对的放置在第二部分642的凹槽644中各自的一个内的第二末端。元件650、652的末端可包含一结构,该结构与沿着各自的凹槽634、644形成的棘齿表面互相交叉。在图23所示的非扩张结构中,元件652、654的末端放置在各自的凹槽634、644的外侧端。
当第一和第二部分632、642被在空腔638中使用可扩张元件55双向互相移开时,如箭头640所示,则元件650、652的末端沿每个各自的第一和第二部分632、642的凹槽634、644纵向移向另一个,如图24所示。刚性元件652、654将第一和第二部分632、642相互移开,并且沿凹槽634、644啮合棘齿表面,以在第一和第二部分632、642间保持扩张的或分离的位置,如图24和25所示。因此可扩张设备是垂直可塌陷的,以便于使用输送装置插入塌陷的盘间隙,并且此后是垂直可扩张的以分离盘间隙和在手术后保持分离。
现参考图26-28,示出使用这里说明的可扩张设备用于恢复侧凸脊柱节段的一个技术的各种步骤。图26-28将参考可扩张设备30、330被说明,应明确这里说明的其他可扩张设备实施例也可应用在这个技术中。在图26中,脊柱节段包含分别在终板E1和E2间具有变形的或塌陷的盘D的椎骨V1和椎骨V2。可扩张设备230被以非扩张状态放置在脊柱中线M侧的盘间隙D中,脊柱节段对该脊柱中线M是凹面弯曲的。
在图27中,可扩张设备例如使用输送装置250的可扩张元件255来扩张,以使终板E1和E2相互移开,并进入更平行或自然的位置,得到恢复的盘间隙D1。在图28中,第二可扩张设备330被放置在脊柱中线M的相对侧的盘间隙D1,并扩张以提供平衡的双面脊柱节段的支撑。
对于多水平侧凸矫正过程,使用一个或多个另外的放置在其他椎骨水平的盘间隙中的可扩张设备230恢复理想的脊柱节段也被考虑。在可扩张设备230、330扩张后,空腔可被填充材料填充,譬如移植骨、移植骨代用品、和用于促进愈合的骨促进材料。若想要保持一个或多个恢复的椎骨水平的运动,则运动保留设备可被插入可扩张设备230、330的空腔,如下面进一步的说明。
图29-30提供可扩张设备230、330的实施方案的正视图。可扩张设备230包含第一部分232和第二部分242,第一部分232和第二部分242限定其中的空腔240。第一部分232包含侧壁234,每个侧壁包含臂235。凹槽238沿臂235的一端形成。臂235包含沿凹槽238延伸的啮合表面23。第二部分242同样地包含侧壁244,每个侧壁包含臂245和凹槽248,臂245被容纳在凹槽238中,以及臂235被容纳在凹槽248中。臂245包含沿此延伸的啮合表面247,该啮合表面247与毗邻的第一部分232的臂235的啮合表面237相啮合。
在图29和31中,可扩张设备230被显示处于塌陷状态,在第二部分240的臂245完全进入毗邻第一部分230的凹槽238的情况下。非扩张状态的可扩张元件255被放置空腔240中,以及可扩张设备230非扩张。在图30和32中,可扩张元件255被扩张以互相移开第一和第二部分232、242至一个扩张的结构。啮合表面237、247可互相交叉和相互啮合,以维持可扩张设备230处于扩张状态,即使压缩负荷被施加至第一和第二部分232、242。啮合表面237、247可具有棘齿的或其它适当的结构,该结构允许第一和第二部分232、242互相离开的运动,而阻挡或阻止第一和第二部分232、242互相靠近的运动。
在图33中,可扩展元件255被去除,以及运动保留设备270被放置在扩张的可扩张设备230的空腔240中。运动保留设备270可包括弹性核272和可沿第一和第二部分232、242的各自部分放置的上、下板274、276。在运动保留设备270被放置在空腔240中情况时,在第一和第二部分232、242的啮合表面之间的接触被消除,以使负荷由弹性核272支撑。例如,臂235、245中一个或两个和/或啮合表面237、247可被去除,或随时间的过去而被吸收。在第一和第二部分232、242之间的压缩负荷支撑能力的去除允许压缩负荷由弹性核272支撑。
弹性核272允许被压缩的毗邻椎骨间的运动,同时维持毗邻椎骨终板间的理想放置。通过去除负荷支撑臂和/或在第一和第二部分232、242间的啮合表面237、247,可实现在第一和第二部分232、242之间由刚性负荷支撑臂235、245支撑的负荷至弹性核272的转移。在一个实施方案中,通过在第一和第二部分232、242之间的刚性负荷支撑的体内降解可实现负荷去除。例如,刚性负荷支撑臂235、245,或整个第一和第二部分232、242可由生物可再吸收多聚物或其他生物可降解的或可再吸收的材料制造。
在一个实施例,通过将可聚合的多聚物注射入可扩张元件255,弹性核272可被形成在手术部位。通过将第一和第二部分232、242互相移开并与毗邻椎骨终板接触,多聚物使可扩张元件255扩张和恢复盘间隙高度。在聚合后,轴252可被分离,和可扩张元件255保留在可扩张设备230的空腔中。可扩张元件255可具有与在第一和第二部分232、242之间的空腔相匹配的大小和形状,以沿其整个长度提供弹性负荷支撑。在使用这种类型弹性核的实施方案中,设备20不需要具备在第一和第二部分232、242之间的刚性负荷支撑臂。
图35A和35B分别是放置在脊柱V1和V2之间的塌陷的盘间隙D内、另一实施方案的一对塌陷的可扩张设备700和相关的输送装置710的平面图和正视图。塌陷的或非扩张的可扩张设备700围绕各自的位于输送装置710的远端的非扩张的可扩张元件714固定,以输送至塌陷的盘间隙D。在图解说明实施方案中,从后通道进入盘间隙D,尽管也考虑了其他通道。可扩张设备700包含在相对侧703、705之间的宽度。
图36A和36B分别是平面图和正视图,其中可扩张设备700由通过输送装置710的轴712输送的液体扩张。在已扩张状况下,可扩张设备700的下和上表面702、704作用于毗邻椎骨终板E1、E2上以分离椎骨V1、V2,并提供恢复的盘间隙D1。在扩张期间和扩张后,可扩张设备700在相对侧703、705之间的宽度几乎保持不变。因此设备700是垂直可扩张的以增加它们的高度而它们的宽度保持恒定。
可扩张设备700沿其长度在前和后端间是逐渐变细的。在已图解说明的实施方案中,后端包含第一高度708,以及前端包含大于第一高度708的第二高度709。逐渐变小的高度在终板E1、E2间提供一可能需要的理想角度。还考虑了设备700可在前端逐渐变细。
图37A和37B分别是平面图和正视图,其中已扩张的可扩张设备700位于脊柱节段已恢复的盘间隙D1内,并且输送装置710被从可扩张设备700的空腔706中去除。用于融合或在毗邻椎骨间维持运动的填充材料可被放置在空腔706中。
图38A和38B分别是放置在脊柱V1和V2之间的塌陷的盘间隙D内、另一实施方案的一对塌陷的可扩张设备720和相关的输送装置730的平面图和正视图。塌陷的或非扩张的可扩张设备720围绕各自的位于输送装置730的远端的非扩张的可扩张元件734、736安装,以输送至塌陷的盘间隙D。可扩张设备720每个包含后方部分723和前方部分725,以及在相对侧727、729之间的宽度。可扩张设备720的高度和宽度在其塌陷的或非扩张状态中沿部分723、725基本上是一致的。
图39A和39B分别是平面图和正视图,其中可扩张设备720由通过输送装置730的轴732输送的液体扩张。在已扩张状况下,可扩张设备720的后方和前方部分723、725作用于毗邻椎骨终板E1、E2上以分离椎骨V1、V2,并提供恢复的盘间隙D1。在扩张期间和扩张后,可扩张设备720在相对侧727、729之间的宽度几乎保持不变。因此设备720是垂直可扩张的宽度保持恒定。
可扩张设备720在前路部分725和后路部分723之间的高度是阶梯变化的,以为已扩张的可扩张设备720提供较大的前方高度。阶梯变化的的高度在终板E1、E2间提供一理想角度。还考虑了设备720在前方高度上可以是向下阶梯变化的。为便于这个阶梯样分离,输送装置730可具有前方可扩张元件734和后方可扩张元件736。可扩张元件734、736可在其扩张的结构中具有不同高度,该高度与放置可扩张元件734、736的前方和后方部分725、723的各自的扩张的高度相一致。
图40A和40B分别是平面图和正视图,其中已扩张的可扩张设备720位于脊柱节段恢复的盘间隙D1中,并且输送装置730被从可扩张设备720的空腔726中去除。用于融合或在毗邻椎骨间维持运动的填充材料可被放置在空腔726中。
图41A和41B分别是放置在脊柱V1和V2之间的塌陷的盘间隙D内、另一实施方案的一对塌陷的可扩张设备740和相关的输送装置750的平面图和正视图。塌陷的或非扩张的可扩张设备740围绕各自的位于输送装置750的远端的非扩张的可扩张元件754安装,以输送至塌陷的盘间隙D。在塌陷状态中,可扩张设备740包含一凸面弯曲的前壁742和凹面弯曲的后壁744。壁742、744形成香蕉形或肾形,该形状便于从单一通道将可扩张设备740放置在盘间隙中用于对椎骨V1和V2的双侧支撑。
图42A和42B分别是平面图和正视图,其中可扩张设备740由通过输送装置750的轴752输送的液体扩张。在已扩张状况下,可扩张设备740的上方和下方部分747、748作用于毗邻椎骨终板E1、E2以分离椎骨V1、V2,并提供恢复的盘间隙D1。可扩张设备740的扩张可引起后壁744向后移动,以使在已扩张状况下,后壁744基本上是线性的,以使可扩张设备740具有D形。
可扩张设备740包含凸面弯曲的前壁742,该壁742便于可扩张设备740沿着弯曲的插入路径的放置,在该路径中前壁742与终板E1、E2的弯曲前部的曲线相一致。在已图解说明的实施方案中,可扩张设备740被放置在盘间隙D的前半部分。可扩张元件754在被扩张时可具有与D形内腔746相一致的形状。
图43A和43B分别是平面图和正视图,其中已扩张的可扩张设备740位于脊柱节段恢复的盘间隙D1中,并且输送装置750被从可扩张设备740的空腔746中去除。用于融合或在毗邻椎骨间维持运动的填充材料可被放置在空腔746中。
图44A和44B分别是放置在脊柱V1和V2之间的塌陷的盘间隙D内、另一实施方案的一对塌陷的可扩张设备760和相关的输送装置770的平面图和正视图。塌陷的或非扩张的可扩张设备760围绕各自的位于输送装置770的远端的非扩张的可扩张元件774安装,以从侧通道中输送至塌陷的盘间隙D。可扩张设备760包含沿可扩张元件774的相对侧啮合的及可毗邻各自终板E1和E2放置的第一部分762和第二部分764。
图45A和45B分别是平面图和正视图,其中可扩张设备760通过操作输送装置770的轴772以扩张可扩张元件774而被扩张。在已扩张状况下,可扩张设备760的第一和第二部分762、764作用于毗邻椎骨终板E1、E2以分离椎骨V1、V2,并提供恢复的盘间隙D1。
图46A和46B分别是平面图和正视图,其中已扩张的可扩张设备760位于脊柱节段恢复的盘间隙D1中,并且输送装置770被从可扩张设备760的空腔766中去除。用于融合或在毗邻椎骨间维持运动的填充材料可被放置在空腔766中。
输送装置770的进一步的细节被提供在图47A和47B中。轴772包含近端手柄部分773和延伸通过可扩张元件774的远端部分776。可扩张元件774包含第一枢转连接778和第二枢转连接780。连接778、780每一个包含一中间枢转点,该中间枢转点与远端部分776啮合并是可移动。连接778、780进一步包含连接在其上和下端的分离元件782、784。
远端部分776被连接至连接778、780,以使当轴772如图47A所示使用手柄部分773绕其轴旋转时,连接778、780的枢转中间部分被拉向彼此以移动分离元件782、784彼此离开,如图47B所示。当被放置在可扩张元件的空腔中时,分离元件782、784接触可扩张设备毗邻的部分,以扩张该可扩张设备和分离盘间隙。当获得理想的分离时,通过以相反方向旋转轴772和朝向彼此移动分离元件782、784,可扩张设备770可从移植物中去除。
图48A和48B分别是放置在椎骨V1和V2之间塌陷的盘间隙D内的另一实施方案的塌陷的可扩张设备800和相关输送装置820的平面图和正视图。该塌陷的或非扩张的可扩张设备800围绕位于输送装置800远端的非扩张的可扩张元件824安装,用于在一前方通道内输送至塌陷的盘间隙D。可扩张设备800包含一第一部分802和一第二部分804,该第一和第二部分沿着可扩张元件824的相对的两侧啮合并可毗邻终板E1和E2中各自的一个放置。
第一和第二部分802、804包含占据了毗邻椎骨终板相当大部分的大小和形状,以为负荷的分散提供大的表面面积。在一个实施方案中,第一和第二部分占据椎骨终板的一半以上,并包含一个穿越脊柱中线延伸的宽度以提供对毗邻椎骨的双侧支撑。第一和第二部分802、804每一个都包含如图示的D形、卵圆形、圆形、矩形、或具有圆形前和后壁的矩形的各终板接触表面。
第一部分802包含多个从那延伸的啮合元件806,该啮合元件朝向毗邻的椎骨终板E2延伸。类似地,第二部分804包含多个从那向终板E1延伸的啮合元件806。在非扩张结构中,第一和第二部分802、804包含一个高度,该高度允许啮合元件806、808沿着终板E1、E2移动而不啮合终板和不妨碍设备800在盘间隙内的放置。
图49A和49B分别是平面图和正视图,其中可扩张设备800被增大或膨胀的可扩张元件824扩张。在该扩张的状态下,可扩张设备的第一和第二部分802、804作用于毗邻的椎骨终板E1、E2上,以分离椎骨V1、V2和提供恢复的盘间隙D1。并且,啮合元件806、808被驱动进入毗邻椎骨终板E1、E2以获得第一和第二部分802、804至椎骨V2、V1的固定。然后可扩张元件824可缩小和从可扩张设备800移开。第一和第二部分802、804之间的相对位置可由第一和第二部分802、804与各自的椎骨终板的啮合来保持。考虑了第一和第二部分802、804可如上述由延伸其间的啮合元件相互连接,虽然第一和第二部分802、804的扩张或分离也可仅由它们与各自的椎骨终板的固定来保持。
图50A和50B分别是平面图和正视图,其中扩张的可扩张设备800位于脊柱节段的恢复的盘间隙D1内,以及输送装置820从可扩张设备800的腔内被去除。然后可在第一和第二部分802、804之间的空隙或腔内放置一运动保留设备810,如箭头818所指示的。该动作保护设备810可以如上所讨论的是一个弹性的核。在一个实施方案中,该弹性核812包含上方和下方凸面弯曲的表面814、816,该表面接触第一和第二部分802、804中毗邻的一个,以便于毗邻椎骨间关于弹性核812的运动。
于是脊柱的负荷可被传递至运动保留设备810以允许在那被支撑的脊柱节段的运动。传递脊柱负荷可通过在第一和第二部分802、804之间延伸的负荷支撑元件或啮合元件的移动来完成,或通过朝向彼此移动第一和第二部分802、804来完成,如上面讨论的。进一步考虑运动保留设备810可以一减小尺寸的结构插在第一和第二部分802、804之间,以及此后释放或扩张以接触毗邻的第一和第二部分802、804。进一步考虑椎骨V1、V2可被过度-分离以容纳运动包护设备810的插入,然后被压缩使第一和第二部分802、804与此接触。
仍然另一个实施方案中,可扩张元件824包含一运动保留设备810的外壳。在该实施方案中,可扩张元件824被一种适当的可聚合的材料膨胀。该可聚合的材料可以在原位固化,以及孔口或轴822被切断或去除,这样可扩张元件824的弹性核在手术后保留在第一和第二部分802、804之间。
此处的可扩张设备可具有一个或更多开口、窗、或其它结构,其允许它的内腔和毗邻的骨结构之间的连通以便于骨向内生长。该可扩张设备可包含一个单一的腔或多个腔。进一步考虑了该可扩张设备可具有支撑机构,该支撑机构可放置在腔内以保持或协助保持该设备的扩张的状态。
此处讨论的可扩张设备可由任何生物相容性材料制成,该生物相容性材料包含金属、聚合物和合成物。金属的例子包含钛和钛合金;镍钛合金;不锈钢;和钴铬合金。聚合物的例子包含例如聚芳醚酮;聚醚醚酮;聚砜;聚烯烃;聚乙烯;酪氨酸基聚碳酸酯;聚酯;聚交酯;聚乙醇酸交酯(polyglicolide);聚原酸酯;聚磷腈;聚羟基丁酸酯;和聚羟基戊酸酯。合成物的例子包含例如碳填充合成物;羟磷灰石填充合成物;生物活性玻璃填充合成物;和皮质骨片填充合成物。
虽然本发明在附图和前述中被详细图示解释和说明,但图示解释和说明的本发明被认为是说明性的和不具限制特性,在本发明的宗旨范围内的所有变化和改良都要求被保护。

Claims (71)

1.一种用于椎骨间稳定的方法,所述方法包括:
进入椎体间的盘间隙;
输送处于非扩张状态的可扩张设备进入盘间隙;
用一个可扩张元件扩张该可扩张设备以分离盘间隙;和
在该扩张的可扩张设备的腔内放置运动保留设备。
2.如权利要求1所述的方法,其中,进入盘间隙包括从后方通道进入盘间隙。
3.如权利要求1所述的方法,其中,进入盘间隙包括从前方通道进入盘间隙。
4.如权利要求1所述的方法,其中,进入盘间隙包括从后侧方通道进入盘间隙。
5.如权利要求1所述的方法,其中,进入盘间隙包括从侧方通道进入盘间隙。
6.如权利要求1的方法,进一步包括在输送可扩张设备之前,在输送装置的远端部分上安装可扩张设备。
7.如权利要求6所述的方法,其中,远端部分包含可扩张元件,且扩张可扩张设备包括在可扩张元件内放置可聚合材料。
8.如权利要求7所述的方法,放置运动保留设备包括在可扩张元件内固化可聚合材料。
9.如权利要求1所述的方法,其中,扩张可扩张设备包括膨胀可扩张元件。
10.如权利要求9的方法,进一步包括在输送可扩张设备之前,当可扩张元件处于缩小状态时将可扩张设备安装在可扩张元件上。
11.如权利要求1所述的方法,其中,扩张可扩张设备包括使可扩张设备的第一部分和第二部分彼此移开,以接触椎体中毗邻的一个的终板。
12.如权利要求11所述的方法,其中,第一部分和第二部分几乎是刚性的。
13.如权利要求12所述的方法,其中,第一部分和第二部分包含沿其外表面的骨啮合特征。
14.如权利要求11所述的方法,其中,第一部分和第二部分在可扩张设备的近端和远端之间延伸,当扩张时第一部分和第二部分形成毗邻远端的第一高度和毗邻近端的第二高度时,第一和第二高度中之一大于第一和第二高度中之另一。
15.如权利要求14的方法,进一步包括在盘间隙中将第一和第二高度中之较大者定位在前面。
16.如权利要求1所述的方法,其中,各椎体包括一侧凸的脊柱节段的凹面弯曲部分,盘间隙包含沿脊柱节段中线一侧的塌陷的高度,以及扩张可扩张设备恢复塌陷的盘间隙和减少凹面弯曲部分的侧凸曲率。
17.如权利要求1所述的方法,进一步包括:
在放置运动保留设备之前使用扩张的可扩张设备临时支撑盘间隙;和
去除扩张的可扩张设备的负荷支撑元件,以传递脊柱负荷至运动保留设备。
18.如权利要求17所述的方法,其中,去除负荷支撑元件包含在原处降解负荷支撑元件。
19.一种用于椎骨间分离的方法,所述方法包括:
进入椎体间塌陷的盘间隙;
将可扩张设备安装于位于输送装置远端部分的可扩张元件上;
使用输送装置向盘间隙内输送一个处于非扩张状态的可扩张设备;
通过扩张可扩张元件来扩张可扩张设备以恢复盘间隙的高度;
从扩张的可扩张设备中去除可扩张元件;和
使用扩张的可扩张设备保持恢复的盘间隙高度。
20.如权利要求19所述的方法,进一步包含在扩张的可扩张设备内放置骨填充材料。
21.如权利要求19所述的方法,其中,可扩张元件被放置在可扩张设备的第一和第二部分之间确定的空腔中。
22.如权利要求19所述的方法,其中,可扩张元件包括可被液体膨胀的内部。
23.如权利要求19所述的方法,其中,进入盘间隙包括从选自:前面、侧面、侧后和后面外科手术通道的通道进入盘间隙。
24.如权利要求19所述的方法,其中,扩张可扩张设备包括将可扩张设备的第一部分和第二部分彼此移开。
25.如权利要求24所述的方法,其中,第一部分和第二部分实质上几乎是刚性的。
26.如权利要求24所述的方法,其中,每个第一部分和第二部分在可扩张设备的近端和远端之间延伸,当通过毗邻远端的第一高度和毗邻近端的第二高度分离扩张的第一部分和第二部分时,第一和第二高度中之一大于第一和第二高度中之另一。
27.如权利要求26所述的方法,其中,可扩张设备在扩张时在远端和近端之间是逐渐变细的。
28.如权利要求26所述的方法,其中,可扩张设备在扩张时在远端和近端之间是阶梯结构的。
29.如权利要求19所述的方法,其中,可扩张设备包含在扩张的和非扩张的状态中几乎相同的宽度。
30.如权利要求19所述的方法,其中,可扩张设备是放射状可扩张的。
31.如权利要求19所述的方法,其中,输送可扩张设备包括沿盘间隙的前部定位凹形弯曲的前壁。
32.如权利要求31所述的方法,其中,扩张的可扩张设备包含D形。
33.如权利要求19所述的方法,进一步包括:
在扩张的可扩张设备中放置一运动保留设备;和
去除扩张的可扩张设备的负荷支撑元件,以传递脊柱负荷至运动保留设备。
34.如权利要求33所述的方法,其中,去除负荷支撑元件包含在原处降解负荷支撑元件。
35.一种用于稳定脊柱节段的系统,所述系统包括:
包含一个轴和一个沿其远端部分的可扩张元件的输送装置;和
包含一空腔的可扩张设备,在空腔中使用可扩张元件、该可扩张设备被可去除地可安装至可扩张元件,且每个可扩张设备和可扩张元件处于非扩张状态,其中,该可扩张设备在非扩张状态下使用输送装置是可输送至脊椎盘间隙的,且此后通过可扩张元件的扩张是可扩张的以分离脊柱的盘间隙;和
运动保留设备可放置在空腔中。
36.如权利要求35所述的系统,其中,可扩张元件包含具有用于容纳扩张液体的内部的球囊结构。
37.如权利要求36所述的系统,其中,所述扩张液体选自:盐水溶液、压缩气体和放射对比液体。
38.如权利要求36所述的系统,其中,所述扩张液体是可聚合材料。
39.如权利要求36所述的系统,其中,所述运动保留设备包含一个通过固化可聚合材料形成的弹性核。
40.如权利要求36所述的系统,其中,输送装置的轴包含一个与可扩张元件的内部以液体连通的管腔。
41.如权利要求35所述的系统,其中,所述可扩张设备包含在可扩张设备的远端和近端之间延伸的毗邻的第一和第二部分,通过扩张可扩张元件使第一和第二部分彼此移开。
42.如权利要求41所述的系统,其中,每个第一和第二部分使用沿其延伸的骨啮合元件限定外表面。
43.如权利要求41所述的系统,其中,当扩张时,第一和第二部分确定毗邻可扩张设备的远端的第一高度和毗邻可扩张设备的近端的第二高度,第一和第二高度中之一大于第一和第二高度中之另一。
44.如权利要求43所述的系统,其中,所述可扩张设备在第一和第二高度之间是逐渐变小的。
45.如权利要求43所述的系统,其中,所述可扩张设备包含在第一和第二高度之间的阶梯结构。
46.如权利要求41所述的系统,其中,所述第一和第二部分包含贯穿其间的骨生长开口。
47.如权利要求41所述的系统,其中,所述第一和第二部分几乎是刚性的,且可扩张元件是非刚性的。
48.如权利要求41所述的系统,其中,所述第一和第二部分互相啮合,以在可扩张元件从空腔去除后保持可扩张设备处于扩张状态。
49.如权利要求48所述的系统,其中,至少第一和第二部分的一部分是可降解的以传递负荷至运动保留设备。
50.如权利要求35所述的系统,其中,所述空腔在可扩张设备的远端和近端开口。
51.如权利要求35所述的系统,其中,所述可扩张设备是放射状可扩张的。
52.如权利要求35所述的系统,其中,所述可扩张设备包含一宽度和一高度,被扩张的可扩张设备增加高度而宽度保持基本恒定。
53.一种用于分离脊柱的盘间隙的系统,所述系统包括:
包含一个轴和一个沿其远端部分的可扩张元件的输送设备;和
包含一空腔的可扩张设备,在空腔中使用可扩张元件、该可扩张设备被可去除地可安装至可扩张元件,且每个可扩张设备和可扩张元件处于非扩张状态,其中,该可扩张设备在非扩张状态下使用输送装置是可输送至脊椎盘间隙的,且此后通过可扩张元件的扩张是可扩张的以分离脊柱的盘间隙。
54.如权利要求53所述的系统,其中,所述可扩张设备包含第一和第二部分,该第一和第二部分在可扩张设备之间延伸。
55.如权利要求54所述的系统,其中,每个第一和第二部分使用沿其延伸的骨啮合元件限定外表面。
56.如权利要求54所述的系统,其中,当扩张的第一和第二部分限定毗邻可扩张设备远端的第一高度和毗邻可扩张设备近端的第二高度时,第一和第二高度中之一大于第一和第二高度中之另一。
57.如权利要求56所述的系统,其中,所述可扩张设备在第一和第二高度之间是逐渐变小的。
58.如权利要求56所述的系统,其中,所述可扩张设备包含在第一和第二高度之间的阶梯结构。
59.如权利要求54所述的系统,其中,所述第一和第二部分包含贯穿其间的骨生长开口。
60.如权利要求54所述的系统,其中,所述第一和第二部分被构造为在从空腔间去除可扩张元件后保持扩张的结构。
61.如权利要求60所述的系统,进一步包括位于空腔中的弹性核。
62.如权利要求53所述的系统,进一步包括可位于空腔中的骨填充材料。
63.如权利要求62所述的系统,其中,所述骨填充材料包含骨生长促进材料。
64.如权利要求53所述的系统,其中,所述可扩张设备是放射状可扩张的。
65.如权利要求53所述的系统,其中,所述可扩张设备包含一宽度和一高度,被扩张的可扩张设备在增加高度时宽度保持几乎恒定。
66.如权利要求53所述的系统,其中,在非扩张状况中可扩张设备包含香蕉形。
67.如权利要求66所述的系统,其中,在非扩张状况中可扩张设备包含D形。
68.如权利要求53的系统,其中,所述可扩张设备包含可沿上方椎骨的终板定位的第一部分和可沿下方椎骨的终板定位的第二部分,每一第一和第二部分包含几乎占据毗邻终板的尺寸和形状。
69.如权利要求68所述的系统,进一步包括在第一和第二部分之间的运动保留设备。
70.如权利要求69所述的系统,其中,所述运动保留设备包含具有上、下凸面弯曲表面的弹性核。
71.如权利要求70所述的系统,其中,所述每一第一和第二部分包含当扩张时用于固定第一和第二部分至毗邻终板的啮合元件。
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