CN105025846B - 可扩展椎间植入物、系统、套件和方法 - Google Patents
可扩展椎间植入物、系统、套件和方法 Download PDFInfo
- Publication number
- CN105025846B CN105025846B CN201480011188.8A CN201480011188A CN105025846B CN 105025846 B CN105025846 B CN 105025846B CN 201480011188 A CN201480011188 A CN 201480011188A CN 105025846 B CN105025846 B CN 105025846B
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- Prior art keywords
- plate
- tapered member
- implant
- along
- inner chamber
- 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.)
- Expired - Fee Related
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- 238000000034 method Methods 0.000 title description 7
- 210000000988 bone and bone Anatomy 0.000 claims description 47
- 238000003780 insertion Methods 0.000 claims description 41
- 230000037431 insertion Effects 0.000 claims description 41
- 238000002513 implantation Methods 0.000 claims description 5
- 230000002093 peripheral effect Effects 0.000 description 20
- 238000002627 tracheal intubation Methods 0.000 description 8
- 230000004927 fusion Effects 0.000 description 5
- 239000000463 material Substances 0.000 description 5
- 241001456553 Chanodichthys dabryi Species 0.000 description 2
- 208000007623 Lordosis Diseases 0.000 description 2
- 238000000354 decomposition reaction Methods 0.000 description 2
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- 230000002146 bilateral effect Effects 0.000 description 1
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- 239000010936 titanium Substances 0.000 description 1
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Classifications
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2002/4627—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
Abstract
本发明公开了一种植入物,该植入物包括第一板和第二板、第一楔形构件和与该第一楔形构件间隔的第二楔形构件,该第一楔形构件和第二楔形构件将第一板和第二板联接在一起。第一楔形构件和第二楔形被配置成沿第一板和第二板从第一收缩构型平移到第二分开构型。该植入物包括致动构件,该致动构件联接到第一楔形构件和第二楔形构件。致动构件限定朝第一板和第二板延伸的凸缘。致动构件被配置成将第一楔形构件和第二楔形构件从第一收缩构型运动到第二分开构型,使得第一板和第二板彼此分开。
Description
技术领域
本发明涉及可扩展椎间植入物、系统、套件和方法。
背景技术
如果椎间盘退化,则通常期望移除椎间盘。脊柱融合可以用于处理此类状况并且涉及利用诸如保持架或其它垫片的装置来替换退化的椎间盘,所述装置恢复椎间盘空间的高度并且允许骨生长通过该装置以融合相邻的椎骨。脊柱融合旨在通过使对脊柱脉管系统、硬脑膜和神经元的损害最小化来恢复正常脊柱对准、稳定脊柱节段以便正确融合、创造最佳融合环境、并且允许早期主动移动。当脊柱融合满足这些目的时,愈合加快并且患者的功能、舒适度和移动性得以改善。作用于椎间盘空间并且允许骨从相邻的椎体生长通过植入物的上表面和下表面的垫片装置是本领域已知的。但是,仍然需要如下装置:该装置使手术侵袭性最小化同时稳定脊柱节段并产生用于脊柱融合的最佳空间。
发明内容
根据本公开的实施例,可扩展植入物被配置成用于插入限定于第一椎体与第二椎体之间的椎间空间中。植入物限定插入端,该插入端沿纵向与后端间隔开。该植入物能够包括第一板和第二板,该第二板沿与纵向垂直的竖直方向与第一板相对。该植入物能够包括第一楔形构件和沿纵向与该第一楔形构件间隔开的第二楔形构件,该第一楔形构件和第二楔形构件联接到第一板和第二板。每个楔形构件都限定狭窄端,该狭窄端沿纵向与内端间隔开,并且每个楔形构件的内端面向彼此。第一楔形构件和第二楔形构件被配置成沿第一板和第二板沿纵向从第一收缩构型平移到第二分开构型。该植入物能够包括致动构件,该致动构件联接到第一楔形构件和第二楔形构件,该致动构件限定朝第一板和第二板延伸的凸缘,该致动构件被配置成使第一楔形构件和第二楔形构件从第一收缩构型运动到第二分开构型,以便沿竖直方向将第一板和第二板分开。
附图说明
结合附图阅读将更好地理解上文的概述以及下文的对本申请的椎间植入物的示例性实施例的详细说明。为了说明本申请的可扩展椎间植入物,附图示出了示例性实施例。然而应当理解,本专利申请并不限于示出的精确布置方式和手段。在图中:
图1示出了根据本公开的实施例的定位在椎体之间的植入物;
图2A和图2B是分别处于塌缩构型和扩展构型的图1中所示的植入物的透视图;
图3是图1中所示的植入物的分解透视图;
图4A是图1中所示的植入物的板的内部表面的透视图;
图4B是图4A中所示的植入物的板的侧视图;
图4C和图4D分别是图4A中所示的植入物的板的底部平面图和顶部平面图;
图5A、图5B、图5C和图5D是图1中所示的植入物中使用的楔形构件的透视图、侧视图和相对端视图;
图6A和图6B是图1中所示的植入物中使用的致动构件的透视图和侧视图;
图7A和图7B是沿图2A和图2B中的线7-7截取的植入物的剖视图,其示出了塌缩和扩展构型;
图8A是插入工具的透视图,该插入工具用于将图1中所示的植入物插入椎间空间中;
图8B是与图1中所示的植入物的后端接合的工具的透视图;
图8C是根据本公开的另一个实施例的工具的侧视图;
图8D是图8C中所示的工具的植入物支撑端部的局部透视图;
图8E和图8F是支撑植入物的图8D中所示的工具的局部透视图;
图9是根据本公开的另一个实施例的植入物的分解透视图;
图10A和图10B是图9中所示的植入物的楔形构件的透视图和侧视图;
图11A和图11B分别是图9中所示的植入物的板的透视图和下位平面图;以及
图12是根据本公开的另一个实施例的致动构件的透视图。
具体实施方式
参照图1,上位椎体2和相邻的下位椎体4限定在椎体2和椎体4之间延伸的椎间空间9。上位椎体2限定上位脊椎表面6,并且相邻的下位椎体4限定下位脊椎表面8。椎体2和4能够在解剖学上相邻,或者在椎体从椎体2和4之间的位置已被移除之后仍然构成椎体。图1中的椎间空间9在椎间盘切除术后示出,由此椎间盘材料已被移除或至少部分地被移除,以准备椎间空间9来接收椎间植入物或植入物10,如图2A至图2B中所示。插入的且扩展的植入物10能够实现适当的高度恢复。椎间空间9能够根据需要沿脊柱被设置在任何地方,包括脊柱的腰椎、胸椎、和颈椎区域处。
以下描述中使用的某些术语仅为了方便起见并且并非限制性的。词汇“右”、“左”、“下”、和“上”指定附图中的方向,以此作为参照。词汇“内部”或“远侧”和“外部”或“近侧”是指分别朝向和远离植入物及其相关部分的几何中心的方向。词汇“前”、“后”、“上”、“下”、“内侧”、“外侧”和相关词汇和/或短语用于指示所参照的人体内的各种位置和取向,并非旨在为限制性的。术语包括以上列举的词汇、它们的派生词以及具有类似含义的词汇。
植入物10在本文中被描述成沿纵向“L”和横向“T”水平地延伸,并且沿竖直方向“V”竖直地延伸。除非另外指明,否则术语“纵向”、“横向”、和“竖直”用于描述各种植入物部件和植入物部件轴线的正交方向分量。应当理解,尽管纵向和横向示出为沿水平面延伸,并且竖直方向示出为沿竖直平面延伸,但是包含各个方向的平面可在使用期间有所不同。例如,当植入物10被插入椎间空间诸如椎间空间9中时,竖直方向V大体沿上位-下位(或尾-颅)方向竖直地延伸,而由纵向L和横向T限定的水平面大体位于由前-后方向和内侧-外侧方向限定的解剖学平面中。因此,方向术语“竖直”和“水平”仅出于清晰和例证的目的来描述如图所示的植入物10及其部件。
参照图1至图3,可扩展椎间植入物或植入物10在远侧或插入端12与近侧端部或后端14之间延伸,该近侧端部或后端沿植入物轴线1与插入端12间隔。植入物轴线1能够根据需要沿纵向L或者任何其它的线性或非线性方向延伸。后端14被配置成与一个或多个插入器械联接,该一个或多个插入器械被配置成支撑并且承载植入物10进入椎间空间9中,并且/或者致动植入物10从图2A中所示的塌缩构型C变为图2B中所示的扩展构型E。植入物10还能够在上部或第一骨接触表面32与下部或第二骨接触表面132之间延伸,该下部或第二骨接触表面沿竖直方向V与第一骨接触表面间隔。骨接触表面32和132被配置成分别接合相对的椎体4和6。每一个骨接触表面都能够是凸形或部分凸形的,例如,该表面的一部分是凸形而另一部分能够是平面的。骨接触表面32和132还能够限定纹理41,诸如顶端、脊、锥、倒钩、凹入部、或滚花,所述纹理被配置成在植入物10被插入椎间空间9中时接合相应的椎体4和6。骨接触表面32和132可被部分地纹理化。例如,骨接触表面32和132能够包括纹理化和非纹理化部分的特定图案。如本文所用,术语“近侧”及其派生词是指从远侧或插入端12朝近侧端部14的方向。如本文所用,术语“远侧”及其派生词是指从近侧端部14朝向插入端12的方向。如本文所用,术语“上位”及其派生词是指从骨接触表面132朝第一骨接触表面32的方向。如本文所用,术语“下位”及其派生词是指从上部或第一骨接触表面32朝下部或第二骨接触表面132的方向。
继续参照图1至图3,植入物10包括第一或上位板18、沿竖直方向V与上位板18相对的第二或下位板20、以及一对楔形构件。该对楔形构件包括联接到上位板18和下位板20的第一楔形构件22和第二楔形构件24。第一楔形构件22和第二楔形构件24能够沿纵向或植入物轴线1平移,以便沿竖直方向V将上位板18和下位板20分开。植入物10能够包括联接到第一楔形构件22和第二楔形构件24的致动构件26。致动构件26具有凸缘28,该凸缘沿竖直方向V朝向上位板18和下位板20从致动构件26突起。上位板18能够限定第一内腔30并且下位板20能够限定第二内腔31,该第二内腔31与第一内腔30对准并且相对。植入物10被配置成使得当植入物10处于图2A中所示的塌缩构型C时,第一楔形构件22和第二楔形构件24的一部分被至少部分地设置在第一内腔30和第二内腔31中。植入物板和/或楔形构件能够由醚醚酮(PEEK)或者任何其它合适的生物相容性聚合物材料形成。致动构件能够由生物相容性聚合物材料或者金属合金诸如钛或钢形成。应当理解,任何合适的材料能够用于形成如本文中所描述的植入物部件。
参照图3至图4D,上位板18被配置成用于与第一楔形构件22、第二楔形构件24、和致动构件26的至少一部分联接,以用于支撑在凸缘28上。上位板主体17能够限定腔42,该腔被配置成承载第一楔形构件22和第二楔形构件24以及致动构件26。上位板18限定沿纵向L在插入端12与后端14之间延伸的第一或上位板主体17。上位板主体17限定第一骨接触表面32,并且第一内部板接触表面34和第二内部板接触表面38沿竖直方向V与骨接触表面32间隔。上位板主体17还限定沿竖直方向V与骨接触表面32间隔的第一斜坡表面44和第二斜坡表面46。板主体17还限定第一侧33a和与第一侧33a相对的第二侧33b。第一侧33a和第二侧33b沿竖直方向V在骨接触表面32与相应的内部板接触表面34和38之间延伸。板主体17还限定沿方向V从斜坡表面44和46延伸到相应的内部板接触表面34和38的第一竖直表面37和第二竖直表面39。因此,板主体17限定第一侧壁36和第二侧壁40,该第二侧壁沿横向T与第一侧壁36间隔。具体地,第一侧壁36沿横向T在侧33a和竖直表面37之间延伸,并且沿竖直方向V从斜坡表面44和46延伸到内部板接触表面34。第二侧壁40沿横向T在侧33b与竖直表面39之间延伸,并且沿竖直方向V朝内部表面38从斜坡表面44和46延伸。如图所示,腔42沿板主体17的纵向L并且沿横向T在相对的第一壁36与第二壁40之间延伸。第一内腔30与腔42连通,如下文详述。在所示的实施例中,第一壁36和第二壁40与骨接触表面32会聚,以形成渐缩插入端16(图2A)。
继续参照图3至图4D,第一壁36和第二壁40被配置成联接到第一楔形构件22和第二楔形构件24。第一壁36能够限定至少一个狭槽,例如第一狭槽52,以用于接收致动构件26的凸缘28的一部分。第一狭槽52被设置在第一壁36中位于板主体17的插入端12与后端14之间的位置处。第二壁40能够限定至少一个或第二狭槽54,以用于接收致动构件26的凸缘28的另一部分。第二狭槽54被设置在第一壁36中位于板主体17的插入端12与后端14之间的位置处。第二狭槽54与相对的第一狭槽52对准,例如横向地对准,使得每个狭槽52和54定位成接收凸缘28的一部分。第一狭槽52和第二狭槽54还被配置成与凸缘28的结构配合。例如,第一狭槽和第二狭槽具有内轮廓,该内轮廓是曲线的并且与凸缘28的曲线轮廓对应。在其它的另选实施例中,第一狭槽52和第二狭槽54可以具有直线形状。应当理解,狭槽52和54可以具有可滑动地接收凸缘28的一部分的任何期望的形状。例如,如果凸缘28具有方形轮廓,则狭槽52和54能够被配置成与方形凸缘配合。在另选实施例中,第一壁36和第二壁40能够包括多个狭槽,所述多个狭槽沿纵向L间隔开并且被设置在第一壁36和第二壁40上,以接收从致动构件26突起的对应数量的凸缘或凸缘部分。例如,第一壁和第二壁可以包括狭槽52和54以及另外的狭槽52L和狭槽54L(未示出),所述另外的狭槽沿纵向(纵向L)与狭槽52和54间隔开。
板主体17,或者例如第一壁36和第二壁40,能够限定一个或多个突出部56和58,该一个或多个突出部沿横向T从壁36和40突起。突出部56和58被配置成接合第一楔形构件22和第二楔形构件24的一部分,如下文进一步详述。具体地,第一壁36能够限定沿横向T从第一壁36延伸到腔42中的第一组突出部56。第一组突出部56能够包括第一壁突出部56a和第二壁突出部56b,该第二壁突出部沿纵向L与第一壁突出部56a朝近侧间隔。在例示的实施例中,第一狭槽52将第一壁突出部56a与第二壁突出部56a分开。第二壁40能够限定沿横向T从第二壁40延伸到腔42中的第二组壁突出部58。第二组突出部58能够包括第三壁突出部58a和第四壁突出部58b,该第四壁突出部沿纵向L与第三突出部58a朝近侧间隔。在例示的实施例中,狭槽54将第三壁突出部58a与第四壁突出部58b分开。尽管每个壁36和40被示出为具有两个突出部,但是每个壁36和40能够具有单个突出部,或者多于两个突出部。
板主体17,例如第一壁36和第二壁40能够进一步限定被配置成接收第一楔形构件22和第二楔形构件24的一部分的一组倾斜连接凹槽60和62。壁突出部56和58沿横向T从相应的壁36, 40突起,如上文所讨论的那样。壁突出部56和58还沿竖直方向V与相应的第一斜坡表面44和第二斜坡表面46间隔,以限定所述一组倾斜连接凹槽60和62。第一组突出部56a和56b从第一壁36延伸,以便分别限定第一倾斜连接凹槽60a和第二倾斜连接凹槽60b(图4A)。第二连接凹槽60b相对于第一连接凹槽60a被设置在近侧。狭槽52被设置在第一倾斜连接凹槽60a与第二倾斜连接凹槽60b之间。第二组突出部58a和58b从第一壁40延伸,以分别限定第三倾斜连接凹槽62a和第四倾斜连接凹槽62b。第四连接凹槽62b在第三倾斜连接凹槽62a的近侧。狭槽54被设置在倾斜连接凹槽62a与62b之间。第一突出部56a和第三突出部58a还能够被称为远侧定位突出部,而第二突出部56b和第四突出部58b能够被称为近侧定位突出部。此外,第一倾斜连接凹槽60a和第三倾斜连接凹槽62a能够被称为远侧定位连接凹槽,而第二倾斜连接凹槽60b和第四倾斜连接凹槽62b能够被称为近侧定位连接凹槽。
每个相对的倾斜连接凹槽60和62沿纵向L朝相对的植入物或植入物端部12和14从内腔30延伸。板主体17能够限定内腔第一周边部分68和相对的内腔第二周边部分69,该内腔第二周边部分沿第一内腔轴线85与第一周边部分68间隔。内腔周边部分69朝植入物10的后端14朝近侧设置并且内腔周边部分68朝植入物10的插入端12朝远侧设置。远侧定位凹槽60a和62a朝板插入端12从内腔30的第一周边部分68朝远侧延伸,而近侧定位凹槽60b和62b朝后端14从内腔30的第二周边部分69朝近侧延伸。倾斜连接凹槽60和62因此能够可滑动地将第一楔形构件22和第二楔形构件24的脊82和182接收在其中。
继续参照图3至图4C,板主体17限定斜坡表面44和46,例如第一斜坡表面44和第二斜坡表面46,所述斜坡表面被配置成与第一楔形构件22和第二楔形构件24的部分配合并且沿所述部分滑动。第一斜坡表面44大体沿纵向L从内腔30的第一周边部分68朝远侧延伸到插入端12。斜坡表面44倾斜,以邻接并且滑动地接收第二楔形构件24的一部分。第二斜坡表面46沿纵向L朝后端14从内腔30的第二周边部分69朝近侧延伸。斜坡表面44和46还沿横向T在相对的第一板壁36与第二板壁40之间横向延伸。每个斜坡表面44和46能够限定斜坡角度β(未示出),该斜坡角度是相对于内部板接触表面34和38被限定的。应当理解,角度β能够根据需要变化。板主体17还能够限定曲线部分48,该曲线部分被设置在板主体17的后端14处并且与第二斜坡表面46连通。曲线部分48被配置成与下位板20上的对应曲线部分148对准。当板18和20处于如图2A和图7A中所示的塌缩构型时,曲线部分48和148限定进入开口50。进入开口50提供接近致动构件26的通路,如下文进一步详述。
继续参照图3至图4D,上位板18能够包括一个或多个X线标记物。板主体17能够限定一个或多个孔(未示出),该一个或多个孔的尺寸和大小设定成将X线标记物70a接收在其中。如图所示,X线标记物70a被设置在第二壁40中并且朝板18的插入端12定位。相对的板20也能够具有X线标记物170a。当植入物10被插入椎间空间9中并且植入物10从第一构型C扩展成扩展构型E时,标记物70a和170a能够沿竖直方向V分开。通过图像分析,板分开的程度能够通过观察被设置在上位板18中的标记物70a相比被设置在下位板20中的标记物170a分开的程度来确定或指示。
下位板20与上位板18类似地配置。因此,下位板20包括与上文参照上位板18所描述的结构特征对应的类似结构特征。下位或第二板20限定板主体21,该板主体沿纵向L在插入端12与后端14之间延伸。下位板主体21限定第二骨接触表面132、沿竖直方向V与骨接触表面32间隔的第一板接触表面134和第二板接触表面138、以及沿竖直方向V与骨接触表面32间隔的第一斜坡表面144和第二斜坡表面146。因此,下位板主体21限定腔142、第一壁136和第二壁140、第一组突出部156a-b、第二组突出部158a-b、以及倾斜连接凹槽160a-b,162a-b。下位板20的内部表面134和138被配置成与上位板18的内部接触表面34和38相对并且接触。上位板18和下位板20能够在植入物10的后端14处限定相对的凹入部98和99。凹入部98和99被配置成接收插入工具100和300的一部分(图8A-8F)。
第一板18和第二板20还能够限定相应的第一内腔30和第二内腔31,如上文所讨论的那样。每个内腔30和31已被配置成接收第一楔形构件22和第二楔形构件24的至少一部分,以使植入物10的紧凑设计和扩展特性最大化。当植入物10处于塌缩构型C(图2A)时,内腔30和31部分地接收第一楔形构件22和第二楔形构件24的部分,从而允许相比具有未被配置成允许楔形构件的一部分延伸穿过其中的内腔的植入物中所使用的楔形构件,第一楔形构件22和第二楔形构件24的尺寸有所增加。此外,配置的第一楔形构件22和第二楔形构件24能够在扩展时改善植入物10的稳定性。因此,植入物10具有紧凑并且低侵入性的塌缩构型以及尺寸上稳定的扩展构型。当被植入椎间空间9中时,内腔30和31具有促进骨生长的附加益处。第一内腔30和第二内腔31沿纵向L为大体细长的。内腔30和31能够具有其它的形状,例如内腔能够为圆形的(图9-11B)。内腔30沿竖直方向V穿过上位板主体17延伸成与腔42连通。类似地,第二内腔穿过第二或下位板主体21延伸成与腔142连通。上位板主体17能够限定沿板主体17的纵向L延伸的内腔轴线85。内腔轴线85与骨接触表面32或其至少一部分对准,例如内腔轴线85沿竖直方向V与植入物轴线1间隔、与骨接触表面32的一部分对准。板主体17还能够限定内腔第一周边部分68和相对的内腔第二周边部分69,该内腔第二周边部分沿第一内腔轴线85与第一周边部分68间隔。内腔周边部分68朝植入物后端14朝近侧设置,并且内腔周边部分69朝植入物插入端12朝远侧设置。类似地,下位板主体21能够限定第二内腔轴线85a(未示出),该第二内腔轴线沿板主体21的纵向L延伸并且沿竖直方向V与骨接触表面132对准。板主体21也能够限定内腔第一周边部分168以及相对的内腔第二周边部分169,该内腔第二周边部分沿第二内腔轴线85a与第一周边部分168间隔。内腔周边部分168朝后端14朝近侧设置,并且内腔周边部分169朝植入物插入端12朝远侧设置。
参照图3、图5A至图5D,第一楔形构件22和第二楔形构件24被配置成用于可滑动地联接到上位板18和下位板20。第一楔形构件22和第二楔形构件24被类似地配置,为了进行示意性的说明,下文将仅对第一楔形构件22进行描述。第一楔形构件22限定楔形主体74,该楔形主体沿楔形轴线3在狭窄端75与内端76之间延伸,该内端与狭窄端75间隔开。楔形轴线3与植入物轴线1大体对准并且沿纵向L延伸。如图3和图7A中所示,第一楔形狭窄端75朝植入物10的外端或后端14定位,而内端76定位成面向植入物10的远侧端部或插入端12。此外,第二楔形构件24具有楔形主体174,该楔形主体沿楔形轴线3从狭窄端175延伸到内端176,其中狭窄端175朝植入物10的远侧端部或插入端12定位并且内端176朝植入物的近侧端部或后端14定位。因此,第一楔形构件22被定位成使得第一楔形构件22的内端76面向第二楔形构件24的内端176。
主体74限定上位顶端76s,该上位顶端沿竖直方向V与下位顶端76i间隔并且被设置在内端76处。第一或内楔形尺寸H1被限定为上位顶端76s与下位顶端76i之间沿竖直方向V的距离。板主体17能够限定在骨接触表面32与内部接触表面34和38之间延伸的第一板尺寸L51,而板主体21能够限定在骨接触表面132与内表面134和138之间延伸的第二板尺寸52。在一个实施例中,第一或内楔形尺寸H1约为第一板尺寸S的两倍。在一个实施例中,第一或内楔形尺寸H1能够大于或等于第一板尺寸S和第二板尺寸52的和。在一个实施例中,第一或内楔形尺寸H1能够小于或等于第一板尺寸S1和第二板尺寸52的和。
主体74限定楔形形状,该楔形形状被配置成用于可滑动地联接到第一板18和第二板20。主体74限定第一或上位倾斜表面77和与第一倾斜表面77相背对的第二倾斜或下位倾斜表面78。第一倾斜表面77和第二倾斜表面78朝狭窄端75从内端76沿纵向L延伸。第一倾斜表面77与第二倾斜表面78成角度偏置。在一个实施例中,第一倾斜表面和第二倾斜表面形成角度θ,该角度θ被限定在与第一倾斜表面77和第二倾斜表面78一致的相交线之间(图5B)。角度θ能够根据需要变化。第一倾斜表面77能够与内部上位板18上的斜坡表面46可滑动地配合,而第二倾斜表面78能够与下位板20上的第一斜坡表面146可滑动地配合。该主体还限定第一侧79和与第一侧79相背对的第二侧80。第一侧79和第二侧80沿纵向L在内端76与狭窄端75之间延伸,并且沿竖直方向V在第一倾斜表面77与第二倾斜表面78之间竖直地延伸。
第一楔形构件22还包括沿横向T从主体74突起的一个或多个脊82(82a-d)。脊82被配置成将第一楔形构件22联接到上位板18和下位板20。例如,一个或多个脊82可滑动地联接到倾斜连接凹槽60, 62, 160, 162的相应部分。每个脊82a-82d大体沿楔形轴线3在主体74的狭窄端75与内端76之间延伸。脊82a-82d还沿相应的第一倾斜表面77与第二倾斜表面78延伸。脊82a和82c相对于脊82b和82d仅成偏置动作角度。设置在主体74的第一侧79上的竖直间隔开的脊82c和82d能够限定凹入部分86,该凹入部分能够分别接收板18和20的朝远侧取向的突出部56b和156b。设置在侧80上的竖直间隔开的脊82a和82b限定凹入部分84,该凹入部分接收板18和20的朝远侧取向的突出部58b和158b。横向间隔开的脊82a和82c被接收在上位板的倾斜连接凹槽60b和62b中。其它横向间隔开的脊82b和82d被接收在下位板20的倾斜连接凹槽160b和162b中(图3)。
楔形构件主体74还限定第一孔81,该第一孔沿楔形轴线3在狭窄端75与内端76之间延伸穿过主体74。第一孔81被配置成接收致动构件26的至少一部分。在一个实施例中,孔81具有内螺纹,以与致动构件26的对应螺纹部分配合。此外,楔形构件主体74包括另外的孔或者将X线标记物70b接收在其中。
第二楔形构件24与第一楔形构件22类似地配置。第二楔形构件24限定第二主体174。主体174限定沿楔形轴线3与内端176间隔开的狭窄端175、第一倾斜表面177和第二倾斜表面178、从主体174延伸的多个脊182、以及在狭窄端175和内端176之间延伸穿过主体174的第二孔181。第一侧179和第二侧180在倾斜表面177与178之间延伸。主体174,例如主体内端176限定上位顶端176,该上位顶端沿竖直方向V与下位顶端176i间隔开。第二楔形构件具有被限定为上位顶端176s与下位顶端176i之间的距离的楔形尺寸H2(未示出)。H2可等于H1。如图3中所示,第二楔形构件24沿纵向L与第一楔形构件22间隔开,使得第二楔形构件24的内端175面向第一楔形构件22的内端75。第二楔形构件24还包括与脊82a和82d类似的脊182a-182d。
继续参照图3至图4D,致动构件26被配置成将第一楔形构件22和第二楔形构件24联接在一起,同时还在植入物扩展期间为上位板18和下位板20提供稳定性。致动构件26在远侧端部27i与近侧端部27e之间沿纵向L延伸。致动构件26限定在相对的端部27i与27e之间延伸的轴87。凸缘28沿横向T或径向方向R从轴87突起。凸缘28限定凸缘主体28b、面向远侧表面29d和面向近侧表面29p,该面向近侧表面沿纵向L与面向远侧表面29d间隔。凸缘主体28b的大小和尺寸设定成在板18的狭槽52和54以及板20的狭槽152和154内滑动。径向方向R能够与横向T和竖直方向对准并且用于指示凸缘28从轴87径向地突起。凸缘28能够具有其它的构型,并且这样一来,笛卡尔坐标可以更好地指示方向分量。
轴87能够限定相对于凸缘28朝近侧设置的第一螺纹部分88和从凸缘28朝远侧设置的第二螺纹部分89。第一轴部分88能够具有从凸缘近侧面29p延伸到近侧端部27e的长度L1,并且第二螺纹部分89具有从凸缘远侧面29d延伸到远侧端部27i的第二长度L2,其中第一长度L1大于第二长度L2。轴87被配置成延伸穿过第一楔形构件22的孔81并且延伸到曲线部分48和148中或者板的进入开口50中。第一螺纹部分88具有螺纹图案,该螺纹图案沿与形成在第二螺纹部分89上的螺纹图案相反的方向取向。第一孔81和第二孔181的内螺纹处于相反取向,使得当致动构件26旋转时,第一楔形构件22和第二楔形构件24根据致动构件26的旋转方向沿致动构件26朝向彼此或者远离彼此平移。每个部分上的螺纹图案可具有相同的节距,使得第一楔形构件22和第二楔形构件24能够以相同速率沿致动构件26平移。当在扩展构型中需要不同的牵引轮廓时(例如,脊柱后凸或脊柱前凸),如果需要,则螺距可不同。致动构件26的近侧端部27e能够限定唇缘94,该唇缘被配置成邻接第一楔形构件22的狭窄端75。唇缘94能够有助于防止致动构件26相对于第一楔形构件22移位。致动构件26的近侧端部27e能够限定凹部90,该凹部被配置成接收或支撑器械的一部分,如下文进一步详述。凹部90能够根据需要具有任何构型,以接收器械,诸如六角形、菲利普斯曲线、平面、星形等。
如本文中所描述的植入物10能够具有初始尺寸和扩展尺寸。例如,该植入物能够具有被限定在第一骨接触表面32和第二骨接触表面132的相对的部分11a和11b之间的第一植入物高度D1以及在植入物扩展时被限定在第一骨接触表面32和第二骨接触表面132的相对的部分11a和11b之间的第二植入物高度D2(图2A和图2B)。在一个实施例中,第一植入物高度D1能够在7mm至10m之间的范围内,并且第二扩展高度能够在10m至13mm之间的范围内。例如,在一个实施例中,第一高度能够为7mm而扩展的第二高度能够为10mm。在另一个实施例中,第一高度能够为9mm并且扩展的第二高度D2能够为13mm。其它尺寸也是可能的。例如,第一高度能够最高至7mm、9mm或更大。植入物10能够具有长度E,该长度被限定在远侧或插入端12与近侧端部或后端14之间。长度E能够在24mm至32mm之间的范围内。然而,长度E能够比24mm短或者比32mm大。此外,植入物被配置成使得植入物10的长度E是连续的,无论植入物10处于塌缩构型时还是植入物10处于扩展构型时。即,第一楔形构件22和第二楔形构件24被配置成使得当处于扩展构型时,相对的狭窄端75和175平移到植入物后端14或植入物插入端12但是不从植入物后端14或植入物插入端12突起。该构型改善植入物稳定性。
参照图8A至图8C,如本文中所描述的系统包括一个或多个插入工具。插入工具100能够包括柄部105和轴104,该轴朝植入物支撑端部107从柄部延伸。植入物支撑端部107被配置成支撑,例如承载或接合植入物10的一部分。植入物支撑端部107能够包括被配置成并且尺寸设定成被接收在植入物凹入部98和99之间的间隔开的突片101和102。当植入物突片101和102接合凹入部98和99时,工具100能够将植入物10定位并且/或者插入到椎间空间9中。另外的工具350能够用于使植入物10从塌缩构型扩展成扩展构型。工具350能够包括柄部355和从柄部朝植入物支撑端部357延伸的轴354。植入物支撑端部357被配置成接合致动构件26,使得工具350的旋转能够导致致动构件56的旋转。
参照图8D至图8E,在另一个实施例中,工具300能够包括柄部302、连接到柄部302的工具外壳304、和细长插管轴306,该细长插管轴从外壳304朝植入物支撑端部307延伸。外壳304和插管轴306沿插入工具轴线301是细长的。外壳304和插管轴306限定插管(未示出),该插管延伸穿过外壳304和轴306。工具300还包括旋转构件318,该旋转构件限定旋转构件316和细长杆308,该细长杆沿轴线301从旋转构件318朝接合端部310延伸,如图8D中所示。旋转构件318能够在插管中旋转并且能够沿工具轴线301在插管中滑动或平移。工具植入物支撑端部307包括主体320以及从该主体延伸的突片312和314。杆308的接合端部310从主体320突起并且被设置在突片312和314之间。工具300能够用于夹持、插入并且随后使植入物扩展。工具300能够用于通过将突片312和314插入到凹入部98和99中来夹持植入物10,同时旋转构件318能够滑动成与致动构件26接合。例如,接合端部310能够在突片312和314支撑植入物10时联接到致动构件26中的开口90中。旋转构件318能够相对于轴306旋转,使得致动构件26旋转。
参照图7A和图7B,植入物10被配置成从塌缩构型C(图7A)扩展成扩展构型E(图7B)。当处于第一或塌缩构型C时,第一楔形构件22和第二楔形构件24被设置在植入物中,使得内端76和176面向彼此并且彼此间隔开,以在两者间限定间隙。致动构件26联接到第一楔形构件22和第二楔形构件24,使得第一螺纹部分88被设置在第一孔81中并且第二螺纹部分89被设置在第二孔181中。凸缘28在第一楔形构件22和第二楔形构件24的相对的内端76和176之间并且沿相对的内端76和176延伸。倾斜表面77和78与相对的板斜坡表面46和146相邻,而第二楔形构件24倾斜表面177和178与相对的板斜坡表面44和144相邻。内端上位顶端76s和176s延伸到内腔30中并且延伸到包含骨接触表面32的平面中,而内端顶端76i和176i延伸到第二内腔中并且延伸到包含骨接触表面132的平面。凸缘远侧面29d邻接第二楔形构件24的内端176,而凸缘近侧面29p邻接第一楔形构件22的内端76。第一楔形构件22和第二楔形构件24的部分,例如顶端76s-i和176s-i被设置在内腔30和31中,从而允许楔形轮廓有助于板18和20随着第一楔形构件22和第二楔形构件24沿致动构件26的轻微推进而分开。例如,上位顶端76s和176s延伸到例如横贯第一内腔轴线85,使得顶端与上位板18的骨接触表面32大体对准。下位顶端76i和176i延伸到例如横贯第二内腔轴线85a,使得顶端76i和176i与下位板20的骨接触表面132大体对准。
转到图7B和图8A至图8F,当致动构件26通过工具150或350旋转时,致动构件26的第一螺纹部分88导致第一楔形构件22朝植入物10的后端14平移。倾斜表面77和78挤压斜坡表面46和146,以沿竖直方向将上位板18和下位板20分开。脊82a-d沿倾斜连接凹槽60b,160b, 62b, 162b(图7B中未示出)滑动。在第一楔形构件22朝植入物后端14平移时,致动构件26的第二螺纹部分89接合第二孔181并且导致第二楔形构件24朝植入物10的插入端12平移。第二楔形构件24的倾斜表面177和178沿斜坡表面44和144滑动,以便沿竖直方向V将上位板18和下位板20分开。脊182a-182d沿相应的倾斜连接凹槽60a, 160a, 62a, 162a(图7B中未示出)滑动。凸缘28在植入物10致动期间仍然被设置在狭槽52, 54, 152, 154中并且在植入物10扩展时提供附加的稳定性以对抗偏离。图7A和图7B中所示的实施例示出了上位板18沿竖直方向V与下位板20分开,同时仍然大体彼此平行。在其它的另选实施例中,植入物能够被配置成使得实现脊柱前凸或脊柱后凸牵引。例如,致动构件的螺纹部分能够被配置成导致一个楔形构件以相比另一个楔形构件更快的速率平移。在此类实施例中,当植入物10扩展时,上位板18将与下位板20成角度偏置。
参照图9至图11B,根据植入物110的另选实施例,上位板18和下位板20,以及具体地包括相对的凹陷49, 149的内部从内腔30, 131朝植入物的相对端部12, 14延伸。第一构件222和第二构件224可包括从第一楔形构件222和第二楔形构件224的倾斜表面277和278突起的突出突片120, 121, 122和123(突片121未示出)。此外,致动构件226相比上文所描述的致动构件26可具有较短的长度。另外,图9至图11B中所示的植入物110与植入物10类似地被配置。
参照图10A至图10C,凹陷79包括沿竖直方向V从第一斜坡表面44和第二斜坡表面46延伸的第一凹陷49A和第二凹陷49B。凹陷49A, 49B限定肩部51a, 51b, 53a, 53b,当植入物扩展时,楔形构件222和224肩部的一部分抵靠所述肩部。
本公开的另一个方面是用于将可扩展植入物插入椎间空间中的插入和扩展的方法。患者的椎间空间9准备好使用类似的技术。一个或多个试验植入物可用于确定植入物10的合适尺寸。使用工具100(图8A),可扩展植入物能够被夹持在突片101和102之间。接下来,使用单侧和/或双侧后路手术或前路手术将可扩展植入物10插入椎间空间9中椎体之间的合适位置处。接下来,能够使用被配置成与致动构件26的开口90接合的工具350来致动。旋转工具350和致动构件26导致致动构件26将相对的楔形构件22和24沿纵向L同时分开,从而导致第一板沿第二方向与第二板分开,使得第一板在扩展步骤期间与第二板平行。
根据另选实施例,插入和扩展的方法能够使用图8C至图8F中所示的工具300。例如,工具300能够通过将工具突片312和314插入到植入物凹入部98和99中来夹持植入物10。旋转构件318能够滑动成与致动构件26接合。工具300能够用于将植入物插入椎间空间9中。当植入物10处于合适位置时,旋转构件318能够旋转,从而使致动构件26旋转,使得植入物扩展到期望的扩展高度。
尽管已详细描述了本公开,然而应当理解,在不脱离如所附权利要求书所限定的本发明实质和范围的情况下,可对本文作出各种改变、替代和更改。此外,本公开的范围并非旨在仅限于本说明书中所述的具体实施例。本领域普通技术人员将容易地理解,可根据本公开采用与本文所述的对应实施例执行实质上相同的功能或实现实质上相同结果的现有或以后将开发出的工艺、机器、制造、物质的组成、装置、方法、或步骤。
Claims (21)
1.一种用于插入限定于第一椎体和第二椎体之间的椎间空间中的可扩展植入物,所述植入物限定沿纵向方向与后端间隔开的插入端,所述植入物包括:
第一板;
第二板,所述第二板沿与所述纵向方向垂直的竖直方向与所述第一板相对;
第一楔形构件和沿所述纵向方向与所述第一楔形构件间隔的第二楔形构件,所述第一楔形构件和所述第二楔形构件各包括:
沿所述纵向方向与内端间隔开的狭窄端;
第一侧和相对的第二侧,每一侧1)沿着所述纵向方向在所述内端和所述狭窄端之间延伸,和2)沿着所述竖直方向延伸;
一个或多个脊,其从所述第一侧和第二侧中的相应一个沿横向方向突出,所述横向方向垂直于所述纵向方向和所述竖直方向,所述一个或多个脊在相应的楔形构件的所述内端和狭窄端之间的方向伸长,所述一个或多个脊配置成将所述第一板和所述第二板联接在一起,其中每个楔形构件的内端面向彼此,以及所述第一楔形构件和所述第二楔形构件被配置成沿所述纵向方向沿所述第一板和所述第二板从第一收缩构型平移到第二分开构型;和
致动构件,所述致动构件联接到所述第一楔形构件和所述第二楔形构件,所述致动构件限定朝所述第一板和所述第二板延伸的凸缘,所述致动构件被配置成使所述第一楔形构件和所述第二楔形构件从所述第一收缩构型平移到所述第二分开构型,以便沿所述竖直方向使所述第一板与所述第二板分开。
2.根据权利要求1所述的植入物,其中所述致动构件限定在远侧端部和近侧端部之间延伸的轴,所述近侧端部沿所述纵向方向与所述远侧端部间隔,其中所述轴限定第一螺纹部分和在所述第一螺纹部分近侧的第二螺纹部分,其中所述凸缘被设置在所述第一螺纹部分和所述第二螺纹部分之间。
3.根据权利要求2所述的植入物,其中所述第一螺纹部分具有第一螺纹方向,并且第二螺纹部分具有不同于所述第一螺纹方向的第二螺纹方向。
4.根据权利要求3所述的植入物,其中第一楔形构件包括第一孔,所述第一孔沿所述纵向方向在所述第一楔形构件的狭窄端与内端之间延伸,并且所述第二楔形构件包括第二孔,所述第二孔沿所述纵向方向在所述第二楔形构件的狭窄端与内端之间延伸,其中所述第一孔至少部分地接收所述致动构件的第一螺纹部分,并且所述第二孔至少部分地接收所述致动构件的第二螺纹部分。
5.根据权利要求1所述的植入物,其中所述第一板限定朝所述植入物的后端倾斜的第一近侧斜坡,并且所述第二板限定朝所述植入物的后端倾斜的第二近侧斜坡,其中所述第一楔形构件或所述第二楔形构件中的任一者被配置成沿所述第一近侧斜坡和所述第二近侧斜坡朝所述植入物的后端平移。
6.根据权利要求5所述的植入物,其中第一板限定朝所述植入物的插入端倾斜的第一远侧斜坡,并且所述第二板限定朝所述植入物的任一插入端倾斜的第二远侧斜坡,其中所述第一楔形构件或所述第二楔形构件中的另一者被配置成沿所述第一远侧斜坡和所述第二远侧斜坡朝所述植入物的插入端平移。
7.根据权利要求1所述的植入物,其中每个楔形构件限定主体,所述主体具有与第二倾斜表面成角度偏置的第一倾斜表面,其中所述第一倾斜表面和所述第二倾斜表面从所述内端朝所述狭窄端延伸。
8.根据权利要求7所述的植入物,其中每个楔形构件的一个或多个脊从所属的楔形构件的主体突起其中所述一个或多个脊沿所述第一倾斜表面或所述第二倾斜表面中的至少一个延伸,所述一个或多个脊被配置成与所述第一板和所述第二板可滑动地联接。
9.根据权利要求1所述的植入物,其中当所述植入物被配置成从塌缩构型扩展成扩展构型时,其中所述扩展构型被限定为当所述第一板沿所述竖直方向与所述第二板间隔开,其中当所述植入物处于所述塌缩构型时,每个楔形构件的内端邻接所述凸缘。
10.根据权利要求9所述的植入物,其中所述第一板限定第一内腔并且所述第二板限定与所述第一内腔对准的第二内腔,其中当所述植入物处于所述塌缩构型时,所述第一楔形构件和第二楔形构件的至少一部分至少部分地设置在所述第一内腔和所述第二内腔中。
11.根据权利要求10所述的植入物,其中每个楔形构件的内端包括上位顶端和沿所述竖直方向与所述上位顶端间隔开的下位顶端,其中当所述植入物处于所述塌缩构型时,所述上位顶端延伸到所述第一内腔中并且至少与所述第一板的第一骨接触表面对准,并且所述下位顶端延伸到所述第二内腔中并且至少与所述第二板的第二骨接触表面对准。
12.根据权利要求1所述的植入物,其中所述第一楔形构件的内端和所述第二楔形构件的内端间隔开,以至少部分地限定在所述第一楔形构件的内端与所述第二楔形构件的内端之间延伸的间隙,并且所述凸缘被配置成延伸穿过所述间隙并且至少部分地延伸到所述第一板和所述第二板中。
13.根据权利要求12所述的植入物,其中当所述第一楔形构件和所述第二楔形构件从所述第一收缩构型分开成第二分开构型时,所述间隙的尺寸增大。
14.一种用于插入限定于第一椎体和第二椎体之间的椎间空间中的植入物,所述植入物限定沿第一方向与后端间隔开的插入端,所述植入物包括:
第一板;
第二板,所述第二板沿第二方向与所述第一板相对;
第一楔形构件和沿所述第一方向与所述第一楔形构件间隔开的第二楔形构件,所述第一楔形构件和所述第二楔形构件各包括:
沿所述第一方向与内端间隔开的外端;
第一侧和相对的第二侧,每一侧1)沿着所述第一方向在所述内端和所述外端之间延伸,和2)沿着所述第二方向延伸;
一个或多个脊,其从所述第一侧和第二侧中的相应一个沿第三方向突出,所述第三方向垂直于所述第一方向和所述第二方向,所述一个或多个脊在相应的楔形构件的所述内端和外端之间的方向伸长,所述一个或多个脊配置成将所述第一板联接到所述第二板的脊,所述第一楔形构件与所述第二楔形构件间隔,以在所述第一楔形构件与所述第二楔形构件之间限定至少间隙,其中所述第一楔形构件和所述第二楔形构件能够沿所述第一方向沿所述第一板和所述第二板平移;
致动构件,所述致动构件具有联接到所述第一楔形构件的第一部分和沿所述第一方向与所述第一部分间隔的第二部分,所述第二部分联接到所述第二楔形构件;和
凸缘,所述凸缘从所述致动构件至少部分地径向地延伸到所述间隙中并且至少部分地径向延伸到所述第一板和所述第二板中,其中当所述致动构件被致动时,所述第一楔形构件和所述第二楔形构件沿所述第一方向彼此分开,以便沿定向为与所述第一方向垂直的所述第二方向将所述第一板与所述第二板分开。
15.根据权利要求14所述的植入物,还包括延伸穿过所述第一板的第一内腔和延伸穿过所述第二板并与所述第一内腔轴向对准的第二内腔。
16.根据权利要求15所述的植入物,其中所述第一板限定骨接触表面以及与所述骨接触表面相背对的内表面,所述内表面限定从所述第一内腔朝所述第一板的第一端部延伸的第一斜坡和从所述第一内腔朝所述第一板的第二端部延伸的第二斜坡,其中所述第一斜坡和所述第二斜坡与相应的所述第一楔形构件和所述第二楔形构件滑动地配合。
17.根据权利要求16所述的植入物,其中至少所述第一斜坡限定细长凹陷,其中所述细长凹陷被配置成接收突片,所述突片沿所述第二方向从所述第一楔形构件或所述第二楔形构件中的任一者延伸,其中所述突片被配置成邻接所述凹陷的一部分,以便限制所述第一楔形构件和所述第二楔形构件相对于所述第一板推进。
18.根据权利要求16所述的植入物,其中所述第二板限定第二骨接触表面以及与所述第二骨接触表面相背对的内表面,所述第二板的内表面限定从所述第二内腔朝所述第二板的第一端部延伸的第一斜坡和从所述第二内腔朝所述第二板的第二端部延伸的第二斜坡,其中所述第一斜坡和所述第二斜坡与相应的所述第一楔形构件和所述第二楔形构件滑动地配合。
19.根据权利要求14所述的植入物,其中所述第一板限定在所述后端和所述插入端之间延伸的第一骨接触表面以及从所述第一骨接触表面沿所述第二方向延伸的第一对相对壁,并且所述第二板限定在所述后端和所述插入端之间延伸并且沿所述第二方向与所述第一骨接触表面间隔的第二骨接触表面以及从所述第二骨接触表面沿所述第二方向朝所述第一板延伸的第二对相对壁,其中所述第一对相对壁和所述第二对相对壁各至少部分地限定腔,所述腔被配置成支撑所述第一楔形构件和所述第二楔形构件。
20.根据权利要求19所述的植入物,其中所述第一对相对壁中的一个限定设置在所述插入端与所述后端之间的至少一个狭槽,其中所述至少一个狭槽被配置成接收所述凸缘的一部分。
21.根据权利要求19所述的植入物,其中所述第一对相对壁各自限定相对的第一狭槽和第二狭槽,并且所述第二对相对壁限定相对的第三狭槽和第四狭槽,其中所述第一狭槽、第二狭槽、第三狭槽和第四狭槽被设置在所述植入物的插入端与后端之间,并且每个狭槽被配置成接收所述凸缘的一部分。
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AU2014221356B2 (en) | 2018-08-09 |
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EP2961352B1 (en) | 2019-06-12 |
US9717601B2 (en) | 2017-08-01 |
CN105025846A (zh) | 2015-11-04 |
US20140243982A1 (en) | 2014-08-28 |
EP2961352A1 (en) | 2016-01-06 |
WO2014133755A1 (en) | 2014-09-04 |
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