CN101732109A - 用于脊椎内复位的系统 - Google Patents

用于脊椎内复位的系统 Download PDF

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Publication number
CN101732109A
CN101732109A CN200910261569A CN200910261569A CN101732109A CN 101732109 A CN101732109 A CN 101732109A CN 200910261569 A CN200910261569 A CN 200910261569A CN 200910261569 A CN200910261569 A CN 200910261569A CN 101732109 A CN101732109 A CN 101732109A
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CN
China
Prior art keywords
reposition element
intravertebral
intravertebral space
elongated
space
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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.)
Pending
Application number
CN200910261569A
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English (en)
Inventor
J·R·贾斯蒂斯
M·C·席曼
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.)
SDGI Holdings Inc
Warsaw Orthopedic Inc
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Warsaw Orthopedic Inc
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Publication of CN101732109A publication Critical patent/CN101732109A/zh
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Abstract

一种脊椎内复位系统,该系统包括可放置在脊椎内空间中的至少一根细长的复位元件,所述至少一根细长的复位元件具有一直线的插入外形,并可横向于所述插入外形变形,以基本上占据脊椎内空间内的容积,并压缩椎体内的骨松质组织,以在所述至少一根细长元件在脊椎内空间中变形时,对椎体施加向外的矫正力。

Description

用于脊椎内复位的系统
本申请是申请号为03823708.3、申请日为2003年8月26日、发明名称为“用于脊椎内复位的系统和方法”发明专利申请的分案申请。
技术领域
本申请涉及脊椎内复位系统。
背景技术
人们已经研制出各种用于治疗压缩型骨折和其它骨质疏松和/或非骨质疏松状况的器械和方法。这样的方法一般包括由外科医生执行以矫正和稳定压缩性骨折的一系列步骤。通常在所要治疗的骨中形成一空腔,然后将一可充胀的气囊状装置插入骨腔。气球状装置的膨胀致使气囊和/或骨髓周围的骨松质被压紧在骨的内皮层壁上,从而使骨腔扩大和/或压缩性骨折复位。然后使气囊状装置缩小,并从骨腔中去除它。有时将诸如异丁烯酸甲脂接合剂或人造的骨取代物之类的生物相容的填充材料送入骨腔中,并使其能固化成硬化的状态,从而提供对骨的内部结构支撑。
气囊状装置的膨胀和之后的取出可能会在脊椎内空间中留有较大的空隙。在脊椎内空间中产生空隙会导致需要填充物材料以支撑椎骨。还有,气囊状装置要求施加压力,以膨胀气囊和/或将材料插入气囊或气囊膨胀所产生的空间。加压的工作环境可能导致骨松质过度压紧,以及致使放置在脊椎内空间中的材料进入到脊柱管和/或与脊柱相关的静脉结构。因此,需要有一种用于治疗脊椎骨折和其它畸形的外科手术器械和方法,能更加有利地采用该器械和方法来压紧骨松质并支撑复位后的脊柱载荷。
发明内容
本发明提供了至少一种复位元件,它们可与脊柱的骨组织接触而放置在脊椎内空间中,并同时在不加压、无流体的环境下压紧骨组织和占据压紧骨组织所产生的容积。
根据一个方面,一种脊椎内复位系统包括可放置在脊椎内空间中的一根或多根细长的复位元件。所述的一根或多根复位元件各具有一直线的插入外形,并可横向于插入外形变形,以基本上占据脊椎内空间内的容积并压缩椎体内的骨松质组织。当一根或多根细长元件在脊椎内空间中变形时,对椎体施加向外的矫正力。
这些和其它的方面将会从下面的描述中变得明白。
附图说明
图1是根据一实施例的脊椎内复位系统和椎体的侧视图。
图2是图1所示系统的平面图。
图3是一实施例的复位元件的正视图。
图4是另一实施例的复位元件的正视图。
图5是根据另一实施例的脊椎内复位系统和椎体的侧视图。
图6是图5所示系统的平面图。
图7是根据另一实施例的脊椎内复位系统和椎体的侧视图。
图8是图7所示系统的平面图。
图9是根据另一实施例的脊椎内复位系统和椎体的侧视图。
图10是图9所示系统的平面图。
具体实施方式
为了更好地理解本发明的原理,现请参见附图中所示的实施例,并且将使用专门的语言来描述它们。尽管如此,应予理解的是,并不想要藉此来对本发明的保护范围加以限制,这样一些可选形式及对于所示装置的这样一些进一步的修改、以及如这里所说明的本发明原理的这样一些进一步应用都被认为是熟悉本发明所涉及的技术领域的人们一般所能想到的。
参见图1和2,这里所示的是一用于治疗脊柱的系统20。系统20可被放置在用以脊椎内移位、或者脊柱骨折或其它畸形的复位的一脊柱结构的附近。设计成系统20可以用在诸如脊椎成形术之类的椎体内应用场合,以将骨松质压紧在椎体内和/或减少椎体的压缩性骨折。系统20包括一个或多个复位元件以在插入时压缩骨松质组织,并同时占据产生在脊椎内空间中的一容积,以在不加压、无流体的环境中实现脊椎内复位。
其它用途还考虑到诸如撑开牵引相邻椎体之间的空间、如椎间盘空间之类的椎体间应用场合。考虑到脊柱结构可能包括诸如保持架装置或与脊柱治疗相关的任何其它结构之类的脊柱植入物。此外,尽管是以治疗人类脊柱的情况来示出和描述系统20的,但也考虑到可将系统20用于治疗其它动物。还考虑到可与脊柱领域之外的应用场合相关地使用系统20,诸如治疗其它类型的骨结构。
系统20包括一输送件22,该输送件大体沿着一纵向轴线23延伸,并具有一远端部分24和一近端部分26。尽管所述实施例将输送件22描述为具有大体直线、管状的外形,但应予理解的是,输送件22也可以呈其它外形,诸如曲线外形、多个曲线和直线段、两个或多个成角段、铰接外形、和/或可弯曲的外形。输送件22还包括一在近端部分26与远端部分24之间延伸穿过的通道28。输送件22可以设有一封闭的通道28。还考虑了其它的实施例,其中通道28可以沿着输送件22的全部或一部分长度敞开。
在最低限度入侵的外科手术中,输送件22可以定位在椎体100上或靠近其的所要的进入位置附近。尽管没有示出,还考虑可设置观察系统以观察该脊椎内手术。所考虑的观察系统例如可包括:穿过输送件22或穿过一第二入口设置的内窥镜观察系统,设置在输送件22之上或领域观察入口之上的显微镜观察系统、荧光镜和射线照相观察系统,以及外科导航系统。此外,这里所讨论的复位系统可用于最小限度入侵的外科手术,也可用于打开式外科手术中,在后者中,收缩皮肤和组织以至少部分地暴露所要治疗的脊柱结构。
在图1和2中示出了具有一前部102和一后部104的椎体100。前部102包括一上终板106和一相对的下终板108。在所示的实施例中,输送件22设置在沿轴线23至椎体的一后-侧路径中。轴线23与位于脊柱的矢状平面中的轴线110成一角112。后-侧路径、特别是脊柱的腰椎区域中使得对脊柱周围的人体组织的破坏最小,也使要求进入椎体的插入深度最浅。不过,应予理解的是,也可以考虑其它的路径,包括到脊柱的前、前-侧、侧以及后路径。还考虑可以采用多条路径并使用多个输送件22。
一复位系统30可穿过输送件22定位或可穿过输送件22输送,并进入椎体100的脊椎内空间内的一受限的容积中,以复位、移位和/或稳定椎体100的前部102的骨折或变形了的骨段。在图1和2中,复位系统30包括多个离散的复位元件32,它们通过输送件22被引入脊椎内空间114。可顺序地、个别地或小批量地将复位元件32引入脊椎内空间114,从而在复位元件32填充至少一部分的脊椎内空间114时产生一脊椎内撑开牵引力以回复终板106和108之间的椎体100的高度。
如图1所示,考虑复位系统30在其术后外形中可在椎体100占据一定的高度,该高度足以在终板106、108之间延伸,以恢复椎体的高度或其间的形状。还有,尽管不排除去除全部或一部分骨松质的做法,但无需为了容纳复位元件32而去除椎体100中的骨松质。将复位元件32放置在脊椎内空间114的受限空间中会压缩骨松质,从而在椎体100的前部102的皮层骨上产生向后的压力或力。该向后的压力或力使椎体100恢复到所要的终板106、108之间的高度和宽度,从而复位脊椎骨折或其它的畸形。
在图1所示的实施例中,复位元件32大体呈球形,并具有足够的刚度以随机地和径向地推压在彼此上,以在它们通过输送件22被压入脊椎内空间114的受限容积中时压缩骨松质组织。当已通过引入合适数量的复位元件32而合适获得所想要的复位时,可用附加的材料将复位元件32固定在脊椎内空间中,以在术后保持住所获得的脊椎复位效果。例如,可以将可再吸收的骨接合剂、聚合物(聚甲基丙烯酸甲酯)(PMMA)或合适的可流动的可医治材料放置在脊椎内和复位元件32之间的空隙中,以将复位元件32固定在位。此外,材料可包括保持在合适的载体材料内的有效量的骨形态发生蛋白质、转化生长因子β1、类胰岛素生长因子1、血小板衍生的生长因子、成纤维细胞生长因子、LIM矿化蛋白质(LMP)以及它们的组合,或者其它治疗剂或抗传染剂。
还考虑复位元件32可设有一非球形的几何形状,以利于相邻复位元件之间的互锁,如图3中的复位元件36所示。例如,复位元件36包括一平面的外壁部分37,并且还可包括锯齿状、倒钩或其它形式的不均匀的外表面结构特征38,或者其它促进相邻复位元件和复位元件与相邻骨组织的互锁或摩擦接合。还考虑复位元件具有表面结构特征以接纳位于脊椎内空间114和/或骨组织中的材料或者与之互锁。例如,图4中所示的复位元件的外表面上包括凹进部35。空腔或腔室33可以在复位元件的外表面之间延伸,以穿过其接纳材料和/或骨生长,进一步利于术后保持复位元件在脊椎内空间114中的定位。
考虑复位元件32可用在定位在脊椎内空间中并占据其时提供足够撑开牵引力的任何生物相容材料制成。复位元件32的合适材料的例子包括金属材料和非金属材料。金属材料例子包括不锈钢和不锈钢合金、钛和钛合金、形状记忆合金、钴铬合金。非金属、不可再吸收材料的例子包括聚醚醚酮(PEEK)和PEEK复合物、非加强的聚合物、碳加强的聚合物复合物、碳纤维、PMMA、可再吸收的聚合物、氢氧化钙、陶瓷以及它们的组合,以及也可以是其它的材料。可再吸收材料的例子包括聚交酯、聚乙交酯、酪氨酸衍生的聚碳酸脂、聚酐、聚原酸酯、聚膦腈、磷酸钙、氢氧化钙、羟磷灰石、生物活性玻璃以及它们的组合物。适于复位元件32的组织材料的例子包括硬组织、结缔组织、去矿化骨基质以及它们的组合。
现请参见图5和6,图中示出了带有复位元件42的复位系统的另一实施例40。复位元件42可具有上面关于复位元件32所述的任何形式。不过,用连接元件44将复位元件42互连。连接元件44便于在已实现椎体100的复位之后从脊椎内空间114去除一些或所有的复位元件42。如图所示,复位系统40定位在脊椎内空间114中以实现所想要的复位。复位系统40的近侧部分延伸穿过输送件22,在该输送件22中,可容易地接近它以施加一去除力来从脊椎内空间114去除互连的复位元件42。
当去除了复位系统40后,诸如上面关于复位系统30所述的材料可被放置在已恢复椎体的脊椎内空间中,以在术后保持所想要的脊椎内高度和/或外形。其它的实施例考虑可在去除了所有或一部分的复位元件42时,将一个或多个撑开牵引保持装置设置在脊椎内空间中,所述保持装置诸如为保持架、支杆或向终板104、106延伸的间隔装置。
在一个实施例中,考虑连接元件44包括呈细绳、金属线、缆索或类似形式的一个或多个零件,所述零件具有足够的柔性以在复位元件42位于椎体100的脊椎内空间114中时可弯转和扭曲,从而使复位元件42能彼此抵靠地放置。可以将一推动器械或类似的装置与复位系统30和40并排或在其后地插入穿过输送件22的通道28,以利于将复位元件推入脊椎内空间114。
为了将复位元件42固定到连接元件44,可将复位元件42模制在连接元件44周围。还考虑将连接元件44穿线或延伸过各复位元件42或复位元件42子集的本体,或者可以将连接元件44穿线或延伸过设置成穿通各复位元件42或复位元件42子集的孔。还考虑可在相邻的复位元件42之间采用个别的连接元件44,并将这些个别的连接元件44连接到相邻的复位元件42上。
在另一实施例中,考虑复位元件42在术后仍留在脊椎内空间114中。当实现了所想要的复位和/或撑开牵引时,可从系统40在脊椎内空间114中的部分切断系统40在脊椎内空间114外部的部分。然后,可将诸如上面关于复位系统30所述的材料通过输送件22放置在已恢复的脊椎内空间114中,用以在术后保持该已恢复的脊椎内空间114。
现请参见图7和8,图中示出了带有复位元件52的复位系统的另一实施例50。复位元件52可包括一半刚性的金属线、缆索、绞线、细绳、条棒或其它细长形式、可穿过输送件22的通道设置的零件。输送件22能帮助在将复位元件52输送到脊椎内空间114时将其保持或限制呈一直线插入的外形。当复位元件52放置在脊椎内空间114中时,复位元件52可来回地折叠从而以褶状的形式塌倒在自身上,并在其填充脊椎内空间114时撑开牵引和/或复位椎体100。复位元件52就这样地从一直线的插入外形运动到一复位外形,在复位外形中,复位元件52横向于其直线的插入外形延伸,并更加轴向地沿着脊柱的轴线。复位元件52基本上占据压缩骨松质组织时所产生的脊椎内空间的容积。
当已经实现所要的撑开牵引时,可在脊椎内空间处切断复位元件52以保持在其内,用来保持已撑开牵引的脊椎内空间。如上面关于复位系统30所述,可将材料输送到脊椎内空间,以占据复位元件52周围的脊椎内空间的容积,并稳定其在脊椎内空间114中的定位。在另一实施例中,在实现了所想要的撑开牵引和/或复位之后,从脊椎内空间114抽出复位元件52,并将材料和/或撑开牵引间隔件放入去除复位元件52之后在脊椎内空间中所产生的空隙,以在术后保持脊椎内空间114。
先请参见图9和10。图中示出了带有复位装置62的复位系统的另一实施例60。复位装置62可以包括一根或多根半刚性的金属线、缆索、绞线、细绳、条棒或其它细长的、可穿过输送件22的通道28定位的零件。当复位装置62的远端位于脊椎内空间114中时,在复位装置62远端处的复位元件64、66可呈伸入脊椎内空间114中的形式,以对椎体100提供一向外的矫正力或压力。例如,在所示的实施例中,复位元件64、66在被推入脊椎内空间114时朝向相应的一个终板106、108盘卷。当相应的卷加大时,就提供了一向外的力或压力,以恢复脊椎内空间114。复位元件64、66就这样从一直线的插入外形运动到一复位外形,在复位外形中,复位元件64、66沿着中心脊柱轴向轴向地延伸。输送件22在复位装置62插入脊椎内空间114时可将复位装置62帮助保持或限制在一直线的插入形状。
当已实现了所想要的撑开牵引和/或复位时,可在脊椎内空间处切断复位装置62以使复位元件64、66留在其内,用来保持已撑开牵引的脊椎内空间。复位装置62能留在脊椎内空间中,以基本上占据压缩骨松质组织时所产生的脊椎内空间的容积。如上面关于复位系统30所述,可将材料输送到脊椎内空间,以占据复位元件64、66周围的脊椎内空间的容积,从而稳定它们在脊椎内空间114中的定位。在另一实施例中,在实现了恢复椎体100之后,从脊椎内空间114抽出复位元件64、66,并将材料和/或撑开牵引间隔件或者其它装置放入去除复位元件64、66之后的剩余脊椎内空间,以在术后保持脊椎内空间114。
在一实施例中,考虑复位元件52和/或复位元件64、66可用形状记忆合金材料(SMA)制成。更具体地说,已知SMA表现出这样一种特征或性能,即用SMA形成的特殊构件能从初始的“记忆下的”形状或外形变形成一不同的形状或外形,然后重新回到其初始的形状和外形。
其它的实施例考虑复位元件52和/或复位元件64、66可用半刚性的弹性体、弹簧金属或其它的合适材料制成,它们能呈用以在小剖面形状布置中插入的所考虑的外形,并在之后碰撞、折叠、盘卷或以其它方式大体与脊椎内空间114相一致,以对椎体100提供向外的矫正力。
在放置在脊椎内空间中时,复位元件对脊椎内空间提供支撑,还能施加向外的力以复位脊椎骨折或治疗其它的状况。当被插入时,复位元件压缩骨松质组织并同时占据在脊椎内空间中所产生的一容积,以实现在无压力、无流体的环境中的脊椎内复位。可用合适的可流动的材料将复位元件固定在位,这些可流动的材料占据复位元件之间的空隙并保持脊椎内的稳定。也可以将材料放置在脊椎内空间中以保持已去除的复位元件所实现的复位。由于复位在放置可流动的材料之前实现,所以无需在压力下或以很大的量来注入可流动的材料,减少了材料进入脊柱管或静脉结构的可能性。
尽管已在附图和前面的描述中示出和详细描述了本发明,但应认为附图和前面的描述是说明性的,而不是在特征方面加以限制。我们想要保护落入本发明保护范围的所有修改和变形。

Claims (10)

1.一种脊椎内复位系统,该系统包括:
可放置在脊椎内空间中的至少一根细长的复位元件,所述至少一根细长的复位元件具有一直线的插入外形,并可横向于所述插入外形变形,以基本上占据脊椎内空间内的容积,并压缩椎体内的骨松质组织,以在所述至少一根细长元件在脊椎内空间中变形时,对椎体施加向外的矫正力。
2.如权利要求1所述的系统,其特征在于,所述至少一根细长的复位元件通过折叠成褶状形状来在脊椎内空间内变形。
3.如权利要求1所述的系统,其特征在于,所述至少一根细长的复位元件通过盘卷成螺旋形来在脊椎内空间内变形。
4.如权利要求1所述的系统,其特征在于,所述至少一细长的根复位元件用形状脊柱合金材料(SMA)制成。
5.如权利要求1所述的系统,其特征在于,所述至少一根细长的复位元件用选自以下材料组中的一材料制成:半刚性弹性体和弹簧金属。
6.如权利要求1所述的系统,其特征在于,所述至少一根细长复位元件包括一对在所述直线的插入外形中沿着彼此延伸的复位元件,所述一对复位元件在插入在脊椎内空间中时沿远离彼此的方向变形。
7.如权利要求1所述的系统,其特征在于,还包括可放置在受限容积中所述至少一根复位元件周围的材料,用以在术后保持和稳定脊椎内空间中的所述至少一根复位元件。
8.如权利要求7所述的系统,其特征在于,所述材料选自以下材料组:PMMA和可再吸收的骨接合剂。
9.如权利要求1所述的系统,其特征在于,还包括可设置在脊椎内空间附近的一输送件,所述输送件具有用于将所述至少一根复位元件输送到脊椎内空间的一通道。
10.如权利要求9所述的系统,其特征在于,所述输送件将所述至少一根复位元件限制成所述直线的插入外形,并且所述至少一根复位元件在伸出所述输送件的远端后可变形。
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CN100584294C (zh) 2010-01-27
WO2004019815A2 (en) 2004-03-11
WO2004019815A3 (en) 2004-06-24
JP2005537098A (ja) 2005-12-08
EP1536743A2 (en) 2005-06-08
CA2496804A1 (en) 2004-03-11
US20110015680A1 (en) 2011-01-20
US20040097930A1 (en) 2004-05-20
JP4495589B2 (ja) 2010-07-07
US7803188B2 (en) 2010-09-28
CN1688268A (zh) 2005-10-26

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