CN113952086A - 具有可展开刀片状物的植入物 - Google Patents
具有可展开刀片状物的植入物 Download PDFInfo
- Publication number
- CN113952086A CN113952086A CN202111283181.XA CN202111283181A CN113952086A CN 113952086 A CN113952086 A CN 113952086A CN 202111283181 A CN202111283181 A CN 202111283181A CN 113952086 A CN113952086 A CN 113952086A
- Authority
- CN
- China
- Prior art keywords
- blade
- implant
- actuating member
- channel
- lateral edge
- 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.)
- Pending
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Abstract
本申请涉及具有可展开刀片状物的植入物,其中描述了一种用于在脊柱中使用的植入物,其包括附接到刀片状物致动构件的两个刀片状物。每个刀片状物包括突出部分,该突出部分接合刀片状物致动构件中的对应通道。当刀片状物致动构件沿第一轴线平移时,该一个或更多个刀片状物延伸或缩回。每个刀片状物保持在刀片状物致动构件内的通道和植入物的主体内的通道中,这些通道约束每个刀片状物在接近垂直于刀片状物致动构件的运动方向的方向上移动。
Description
本申请是申请日为2017年10月17日,申请号为201780078136.6,发明名称为“具有可展开刀片状物的植入物”的申请的分案申请。
背景
实施方案总体上涉及用于支持患者体内的骨生长的植入物。
各种不同的植入物在身体内被使用。在身体内用于稳定一个区域和促进骨向内生长的植入物为骨向内生长提供稳定性(即,随时间推移在压力下的最小变形)和空间。
脊柱融合术(Spinal fusion),也被称为脊椎融合术(spondylodesis)或脊柱制动术(spondylosyndesis),是用于治疗诸如退行性椎间盘疾病、脊椎前移(脊椎滑脱)、椎管狭窄症、脊柱侧凸、骨折、感染或肿瘤等各种疾病的手术治疗方法。脊柱融合手术的目的是减少不稳定并因而减轻疼痛。
在准备脊柱融合时,椎间盘的大部分被移除。可以将植入物(脊柱融合保持架(spinal fusion cage))放置在椎骨之间以保持脊柱对齐和椎间盘高度。融合(即,骨桥)出现在椎骨的终板之间。
概述
在一个方面中,植入物包括具有第一轴线的主体。植入物还包括刀片状物(blade),该刀片状物具有在主体中的缩回位置和刀片状物从主体向外延伸的延伸位置。植入物还包括刀片状物致动构件,该刀片状物致动构件可以在平行于第一轴线的方向上穿过主体平移。刀片状物致动构件包括通道,其中通道在刀片状物致动构件的上表面和下表面之间延伸,并且其中通道界定第一通道方向和相反的第二通道方向。刀片状物包括构造成配合在通道内的突出部分。当刀片状物致动构件沿第一轴线在第一方向上移动时,突出部分在第一通道方向上跟随通道,并且刀片状物朝向延伸位置移动。当刀片状物致动构件在与第一方向相反的第二方向上移动时,突出部分在第二通道方向上跟随通道,并且刀片状物朝向缩回位置移动。
在另一方面中,植入物包括具有第一轴线的主体。植入物还包括刀片状物,该刀片状物具有在主体中的缩回位置和刀片状物从主体向外延伸的延伸位置。刀片状物具有外边缘、内边缘、第一侧向(lateral)边缘和第二侧向边缘。刀片状物的第一侧向缘和刀片状物的第二侧向边缘与主体接触。刀片状物还具有远侧面和近侧面。植入物包括刀片状物致动构件,该刀片状物致动构件可以在平行于第一轴线的方向上穿过主体平移。近侧面的一部分与刀片状物致动构件接触。远侧面远离主体布置。刀片状物致动构件可以在缩回位置和延伸位置之间移动刀片状物。
在另一方面中,植入物包括具有第一轴线的外部结构。植入物还包括刀片状物,该刀片状物具有在外部结构中的缩回位置和刀片状物从外部结构向外延伸的延伸位置。植入物还包括刀片状物致动构件,该刀片状物致动构件可以在平行于第一轴线的方向上穿过外部结构平移。刀片状物致动构件联接到刀片状物,并且可以在缩回位置和延伸位置之间移动刀片状物。外部结构包括具有螺纹开口和邻近螺纹开口的导引开口的第一端部,其中导引开口接纳刀片状物致动构件的从动端部。植入物还包括固定在螺纹开口内的锁定螺钉。锁定螺钉可以在解锁旋转位置和锁定旋转位置之间旋转,在解锁旋转位置,刀片状物致动构件的从动端部可以穿过导引开口,在锁定的旋转位置,刀片状物致动构件的从动端部被阻止移动穿过导引开口。
在查看了以下附图和详细描述之后,实施方案的其它系统、方法、特征和优点对于本领域的普通技术人员将是明显的或将变得明显。意图是所有这样的另外的系统、方法、特征和优点都被包括在本描述和本概述中,在实施方案的范围内,并且由所附权利要求保护。
附图简述
参考以下附图和描述可更好地理解实施方案。附图中的部件不一定按比例绘制,而是将重点放在图示实施方案的原理上。此外,在附图中,相似的参考数字在全部的不同视图中表示对应的部分。
图1是根据一个实施方案的具有植入物的脊柱的示意图;
图2是植入物的实施方案的等距视图;
图3是图2的植入物的分解等距视图;
图4是处于插入位置的图2的植入物的示意性等距视图;
图5是处于插入位置的图2的植入物的侧向侧视图;
图6是处于展开位置的图2的植入物的示意性等距视图;
图7是处于展开位置的图2的植入物的侧向侧视图;
图8是刀片状物的实施方案的示意性等距视图;
图9是刀片状物致动构件的实施方案的示意性侧视图;
图10是刀片状物致动构件和两个对应刀片状物的实施方案的示意性等距视图;
图11是与两个对应刀片状物联接的图10的刀片状物致动构件的示意性等距视图;
图12是用于植入物的主体的实施方案的示意性等距视图;
图13是根据一个实施方案的植入物的帽的远侧面的示意性等距视图;
图14是图13的帽的近侧面的示意性等距视图;
图15是根据另一实施方案的植入物的主体的示意性等距视图;
图16是植入物的实施方案的自上而下的示意图;
图17是图16的植入物的区域的自上而下的示意图;
图18是根据一个实施方案的处于插入位置的植入物的示意性等距视图,包括数个部件的放大剖视图;
图19是处于中间位置的图18的植入物的示意性等距视图,包括数个部件的放大剖视图;
图20是处于展开位置的图18的植入物的示意性等距视图,包括数个部件的放大剖视图;
图21是处于中间位置的图18的植入物的示意性等距视图,包括数个部件的放大剖视图;
图22是根据实施方案的锁定螺钉的示意性等距视图;
图23是图22的锁定螺钉的示意性侧视图;
图24是图22的锁定螺钉的等距视图,包括锁定螺钉的放大剖视图;
图25是根据一个实施方案的具有处于旋转位置的锁定螺钉的植入物的示意性等距视图,该旋转位置允许刀片状物致动构件从植入物延伸;以及
图26是图25的植入物的示意性等距视图,其中锁定螺钉已经旋转以防止刀片状物致动构件从植入物的主体延伸。
详细描述
本文中描述的实施方案针对用于在脊柱中使用的植入物。实施方案包括具有主体和一个或更多个刀片状物的植入物。除了下面讨论的各种设置部(provisions)之外,任何实施方案均可以利用Duffield等人的发布于2017年7月18日的美国专利号9,707,100中公开的主体/支撑结构、刀片状物、致动构件或其它结构中的任一个,该美国专利最初于2016年6月27日作为美国专利申请号15/194,323提交,并且标题为“Interbody Fusion Deviceand System for Implantation(用于植入的椎间融合设备和系统)”,该专利据此通过引用以其整体并入。为了方便起见,Duffield专利在整个申请中将被称为“The Fusion DeviceApplication(融合设备申请)”。
植入物的介绍
图1是植入物100的实施方案的示意图。植入物100也可以被称为保持架或融合设备。在一些实施方案中,植入物100构造成植入人体的一部分内。在一些实施方案中,植入物100可以构造成用于植入脊柱中。在一些实施方案中,植入物100可以是脊柱融合植入物或脊柱融合设备,其插入相邻椎骨之间以提供支撑和/或促进椎骨之间的融合。例如,参考图1,植入物100已经定位在第一椎骨192和第二椎骨194之间。此外,可以看出,植入物100包括从植入物100的上表面和下表面延伸的两个刀片状物(第一刀片状物241和第二刀片状物242)。刀片状物中的每一个已经被推入相邻椎骨(即,第一椎骨192或第二椎骨194)中,以便帮助锚定植入物100。
在一些实施方案中,植入物100可以使用侧向椎间融合(LIF)外科手术插入。在一些情况下,植入物100可以穿过身体的侧部中的小切口插入。可以使用的示例性技术包括但不限于:(直接侧向椎间融合术)、(极侧向椎间融合术)和经腰肌椎间融合术(transpsoas interbody fusion)。
为了清楚起见,在整个详细描述和权利要求中参考了各种方向性的形容词。如本文中所使用的,术语“前”是指当植入物已经放置在身体内时预期朝向人体前部定向的植入物的一侧或部分。同样,术语“后”是指在植入后预期朝向人体后部定向的植入物的一侧或部分。此外,术语“上”是指预期朝向身体的顶部(例如头部)定向的植入物的一侧或部分,而“下”是指预期朝向身体的下部定向的植入物的一侧或部分。本文中还参考植入物的“侧向”侧或部分,它们是沿身体的侧向方向面向的侧或部分。
图2是根据一个实施方案的植入物100的实施方案的示意性等距视图。如图2中所见,植入物100被理解为构造成具有前侧面110和后侧面112。植入物100还可以包括第一侧向面114和第二侧向面116。此外,植入物100还可以包括上侧面130和下侧面140。
还参考了相对于植入物本身的方向或轴线,而不是植入物关于身体的预期方向。例如,术语“远侧”是指距离植入物的中心更远的部分,而术语“近侧”是指距离植入物的中心更近的部分。如本文中所使用的,“植入物的中心”可以是质心和/或中心平面和/或另一个居中定位的参考表面。
植入物也可以与各种轴线相关联。参照图1,植入物100可以与纵向轴线120相关联,该纵向轴线120沿植入物100的最长维度在第一侧向面114和第二侧向面116之间延伸。此外,植入物100可以与前后轴线122(也称为“横向轴线”)相关联,前后轴线122沿植入物100的横向维度在后侧面112和前侧面110之间延伸。此外,植入物100可以与竖直轴线124相关联,竖直轴线124沿植入物100的厚度维度延伸,并且其大致垂直于纵向轴线120和前后轴线122两者。
植入物也可以与各种参考平面或表面相关联。如本文中使用的,术语“正中面”是指从植入物的前侧面到后侧面的竖直平面,将植入物分成右半部和左半部或侧向半部。如本文中所使用的,术语“横断面”是指位于植入物的中心的水平面,其将植入物分成上半部和下半部。如本文中所使用的,术语“冠状面”是指位于植入物的中心的竖直平面,其将植入物分成前半部和后半部。在一些实施方案中,植入物关于诸如正中面和横断面的两个平面对称。
图3是根据一个实施方案的植入物100的示意性等距分解图。首先参考图2-图3,植入物100包括主体200和帽220,它们一起可以被称为植入物100的外部结构201。在一些实施方案中,主体和帽可以一体形成。在其它实施方案中,主体和帽可以是由一个或更多个紧固件连接的分开的件。在图2-图3的实施方案中,主体200和帽220是分开的件,其使用植入物100的附加部件紧固在一起。
植入物的实施方案可以包括用于将植入物锚定到相邻椎体中的设置部。在一些实施方案中,植入物可以包括一个或更多个锚定构件。在图2-图3的实施方案中,植入物100包括一组刀片状物240,该组刀片状物240有助于在植入物100插入椎体之间后将植入物100锚定到相邻椎体。该组刀片状物240可以进一步包括第一刀片状物241和第二刀片状物242。尽管本文中描述的示例性实施方案包括两个刀片状物,但是植入物的其它实施方案可以包括任何其它数量的刀片状物。例如,在另一个实施方案中,可以使用三个刀片状物。在另一个实施方案中,可以使用四个刀片状物,其中两个刀片状物从植入物的下表面延伸,并且两个刀片状物从植入物的上表面延伸。其它实施方案可以包括五个或更多刀片状物。在又一个实施方案中,可以使用单个刀片状物。
具有刀片状物的植入物可以包括用于相对于植入物的外部结构移动刀片状物的设置部。在一些实施方案中,植入物包括刀片状物致动构件,其与一个或更多个刀片状物接合,以从植入物的表面延伸和/或缩回刀片状物。在图2-图3中所示的实施方案中,植入物100包括刀片状物致动构件260。在一些实施方案中,刀片状物致动构件260联接到第一刀片状物241和第二刀片状物242。此外,通过调节刀片状物致动构件260在外部结构201内的位置,第一刀片状物241和第二刀片状物242可以缩回到植入物100的表面中或从植入物100的表面延伸。
植入物可以包括用于锁定植入物的一个或更多个元件的位置的设置部。在刀片状物致动构件的位置可以改变的实施方案中,植入物可以包括用于将致动构件锁定在给定位置且从而也将一个或更多个刀片状物锁定在给定位置的设置部。在图2-图3中所示的实施方案中,植入物100包括锁定螺钉280。在一些实施方案中,锁定螺钉280可用于将刀片状物致动构件260锁定在植入物100内的适当位置,这确保第一刀片状物241和第二刀片状物242保持在延伸位置。
实施方案可以包括一个或更多个紧固件,该一个或更多个紧固件帮助将主体附接到帽。在一些实施方案中,可以使用销、螺钉、钉子(nails)、螺栓、夹子或任何其它类型的紧固件。在图2-图3中所示的实施方案中,植入物100包括帮助将帽220紧固到主体200的一组销290。在示例性实施方案中,使用两个销,包括第一销291和第二销292。然而,在其它实施方案中,可以使用任何其它数量的销。在另一个实施方案中,可以使用单个销。在其它实施方案中,可以使用三个或更多个销。
操作
本文描述的实施方案提供了植入物,其可以从第一位置(“插入位置”)移动到第二位置(“撞击位置(impaction position)”或“展开位置”),第一位置允许植入物保持低轮廓,第二位置展开刀片状物并将其插入到近侧的上椎体和下椎体中。当植入物处于第一(插入)位置时,设备的刀片状物可以缩回植入物的主体内(即,刀片状物本身可以处于“缩回位置”)。在植入物的第二(展开)位置,刀片状物向上(或向颅侧)或向下(或向尾侧)延伸超过植入物并进入椎体中,以防止植入物随着时间推移移出位置。因此,刀片状物本身可以说处于“延伸位置”或“展开位置”。当刀片状物展开时,植入物抵抗左右旋转并且抵抗弯曲和/或延伸。可以理解的是,尽管刀片状物可以在竖直方向(即,向上方向和向下方向)上大致移动,但是实际的行进方向可以因不同的实施方案而变化。例如,在一些实施方案中,刀片状物可以在植入物内略微地成角度,并且可以相对于竖直方向(或者相对于向下方向/向上方向)以微小的角度展开。
图4-图7图示了在不同操作模式或操作位置的植入物100的数个视图。具体而言,图4是处于插入位置的植入物100的示意性等距视图。图5是处于图4的同一插入位置的植入物100的示意性侧向侧视图。参考图4-图5,在插入位置,刀片状物致动构件260的从动端部262可以布置在帽220的导引开口222的远侧(即,刀片状物致动构件260的一部分穿过导引开口222布置)。当植入物100处于插入位置时,第一刀片状物241和第二刀片状物242缩回外部结构201内。因此,如图5中最佳地看出的,第一刀片状物241或第二刀片状物242均没有分别从植入物100的上侧面130或下侧面140向外(向远侧地)延伸。在该插入位置,植入物100具有紧凑的轮廓,并且可以更容易地操纵到相邻椎骨之间的切除的椎间盘间隙中的适当位置。
图6是处于展开位置的植入物100的示意性等距视图。图7是处于图7同一插入位置的植入物100的示意性侧向侧视图。参考图6-图7,在展开位置,刀片状物致动构件260的从动端部262可以布置在帽220的导引开口222的近侧(即,刀片状物致动构件260的整体布置在植入物100内)。当植入物100处于展开位置时,第一刀片状物241和第二刀片状物242分别从上侧面130和下侧面140向外延伸,以便插入相邻的椎体中。
在一些实施方案中,一个或更多个刀片状物可以相对于植入物的上表面和下表面上的法线方向以微小角度展开。在一些实施方案中,一个或更多个刀片状物可以以0度至30度之间的角度定向。在其它实施方案中,一个或更多个刀片状物可以以大于30度的角度定向。在图6-图7中所示的示例性实施方案中,第一刀片状物241和第二刀片状物242均与法向轴线251成微小角度定向。具体而言,第一刀片状物241与法向轴线251形成第一角度250,并且第二刀片状物242与法向轴线251形成第二角度252。在一个实施方案中,第一角度250和第二角度252均是约15度。以这种方式使刀片状物成角度可以帮助在展开时保持第一刀片状物241和第二刀片状物242在相邻椎骨中大致居中。
在不同的实施方案中,每个刀片状物的延伸可以变化。在一些实施方案中,刀片状物可以向外延伸植入物深度的0%和100%之间的长度。在其它实施方案中,组合刀片状物高度可以向外延伸植入物深度的100%和130%之间的长度。在图6-图7中所示的示例性实施方案中,组合的第一刀片状物241和第二刀片状物242能够从植入物100向外延伸等于植入物100的深度的110%的量。这可以在仍保持刀片状物完全缩回植入物100内时完成,因为刀片状物由主体200中的两个坚固的平行轨道以及刀片状物致动构件260中的成角度的横向通道导引,从而约束所有六个运动轴线。在其它实施方案中,展开时的组合刀片状物高度可以小于100%。在一个实施方案中,植入物可以被设计成使得组合的刀片状物高度小于10mm,以降低使相邻椎体破裂的风险。
刀片状物和刀片状物致动构件
图8是第一刀片状物241的示意性等距视图。第一刀片状物241或简称刀片状物241包括外边缘400、内边缘402、第一侧向边缘404和第二侧向边缘406。这些边缘使远侧面408(即,在远侧方向上定向的面)和近侧面410(即,在近侧方向上定向的面)结合(bind)。
在不同的实施方案中,刀片状物的几何形状可以变化。在一些实施方案中,刀片状物可以具有大体上平面的几何形状,使得刀片状物的远侧面和近侧面各自平行于共同平面。在其它实施方案中,刀片状物可以构造成具有一个或更多个弯曲部。在一些实施方案中,刀片状物可以具有通道状几何形状(例如,“C”形或“S”形)。在图8中所示的实施方案中,刀片状物241具有带由凸缘的U形几何形状。特别地,刀片状物241具有第一通道部分420、第二通道部分422和第三通道部分424。这里,第一通道部分420在第一弯曲部430处相对于第二通道部分422成角度。同样,第三通道部分424在第二弯曲部432处相对于第二通道部分422成角度。另外,刀片状物241包括在第三弯曲部434处从第一通道部分420延伸的第一凸缘440。刀片状物241还包括在第四弯曲部436处从第三通道部分424延伸的第二凸缘442。刀片状物241的这种几何形状与具有相似尺寸和厚度的其它平面刀片状物相比,帮助为刀片状物241提供最佳强度,并允许更大的移植物体积。
在示例性实施方案中,外边缘400是构造成植入相邻椎体内的穿透边缘。为了最大化穿透,外边缘400可以被锐化,使得刀片状物241具有邻近外边缘400的成角度的表面409。此外,在一些实施方案中,第一侧向边缘404和第二侧向边缘406也以类似于外边缘400的方式被锐化,并且可以充当外边缘400的延伸部,以帮助提高强度和穿透性。
刀片状物可以包括用于与刀片状物致动构件联接的设置部。在一些实施方案中,刀片状物可以包括突出部分。在一些实施方案中,突出部分可以远离刀片状物的面延伸,并且可以配合在刀片状物致动构件中的通道内。参考图8,刀片状物241包括从近侧面410延伸的突出部分450。突出部分450可以大致上被设定尺寸并成形为配合在刀片状物致动构件260的通道内(即,图9中所示的第一通道350)。具体而言,横截面形状可以配合在刀片状物致动构件260中的通道内。在一些情况下,突出部分450的横截面宽度可以在近侧部分452和远侧部分454之间增加,允许突出部分450互锁在通道内,如下面详细讨论的。
突出部分可以在刀片状物上以一定角度定向,以便与刀片状物致动构件中的成角度的通道配合。在图9的实施方案中,突出部分450可以相对于内边缘402成角度,使得当突出部分450插入第一通道350内时,刀片状物241在植入物100内竖直地定向。换句话说,突出部分450的最长维度可以与内边缘402形成角度459。
尽管以上讨论针对第一刀片状物241,但是可以理解,类似的原理适用于第二刀片状物242。特别地,在一些实施方案中,第二刀片状物242可以具有与第一刀片状物241大体上相同的几何形状。
图9是刀片状物致动构件260的实施方案的示意性侧视图。图10中还示出了刀片状物致动构件260的等距视图。参照图9和图10,刀片状物致动构件260可以包括从动轴部分320和刀片状物接合部分322。从动轴部分320还包括从动端部262。
在一些实施方案中,从动端部262可以包括一个或更多个接合特征。例如,从动端部262可以包括螺纹开口267,如图10中最佳地看出的。在一些实施方案中,螺纹开口267可以接纳具有相应螺纹末端的工具。利用这种布置,从动端部262可以与工具的端部暂时配合,该工具的端部用于撞击刀片状物致构件260并将该组刀片状物240推动到相邻椎骨中。这可以帮助在撞击期间保持驱动工具和从动端部262对齐,并且减少驱动工具相对于从动端部262滑动的任何趋势。使用配合特征还允许从动端部262更容易地从植入物100向远侧“拉动”,这可用于缩回刀片状物240,如果需要移除植入物100或重新定位刀片状物的话。
刀片状物接合部分322可以包括上表面330、下表面332、第一侧表面334和第二侧表面336。这里,第一侧表面334可以是面向前的一侧,并且第二侧表面336可以是面向后的一侧。然而,在其它实施方案中,第一侧表面334可以是面向后的一侧,并且第二侧表面336可以是面向前的一侧。
刀片状物致动构件可以包括用于与一个或更多个刀片状物联接的设置部。在一些实施方案中,刀片状物致动构件可以包括一个或更多个通道。在图9的示例性实施方案中,刀片状物接合部分322包括第一通道350和第二通道352(在图9中以虚线示出)。第一通道350可以布置在刀片状物致动构件260的第一侧表面334中,而第二通道352可以布置在刀片状物致动构件260的第二侧表面336中。
可以看出每个通道在刀片状物接合部分322的上表面330和下表面332之间以一定角度延伸。例如,如图9中最佳看到的,第一通道350具有沿上表面330开口的第一端部354和沿下表面332开口的第二端部356。此外,第一端部354比第二端部356更靠近从动轴部分320布置。同样,第二通道352包括上表面330和下表面332上的相对的端部,尽管在这种情况下,布置在上表面330处的端部比布置在下表面332处的端部距离从动轴部分320更远地布置。
在不同的实施方案中,可以选择每个通道的角度以为变化的植入物尺寸提供合适的刀片状物延伸部。如本文中所使用的,通道的角度被界定为通道和刀片状物致动构件的横断面之间形成的角度。在图9的实施方案中,第一通道350与刀片状物致动构件260的横断面370形成第一角度372,而第二通道352与横断面370形成第二角度374。在示例性实施方案中,第一角度372和第二角度374相等,以便当刀片状物展开时,提供平衡的反作用力。通过以这种方式构造刀片状物和刀片状物致动构件,每个刀片状物围绕刀片状物致动构件的中心线(例如,横断面370)展开,这帮助在刀片状物展开期间最小化这些部分之间的摩擦和束缚载荷。此外,这种布置帮助提供平衡的反作用力,以减少插入努力和摩擦。
在不同的实施方案中,每个通道的角度可以变化。在一些实施方案中,通道可以以15度和75度之间的任何角度定向。在其它实施方案中,通道可以以35度和65度之间的任何角度定向。此外,在一些实施方案中,通道的角度可以确定对应刀片状物中的突出部分的角度。例如,形成在突出部分450和刀片状物241的内边缘402之间的角度459(见图8)可以约等于形成在第一通道350和横断面370之间的角度372。这保持刀片状物241的外部穿透边缘大致水平,使得穿透程度在刀片状物的不同部分中不变化。
如图10中看出的,每个通道具有有助于与刀片状物的对应部分联接或配合的横截面形状。例如,通道350在第一侧表面334上具有开口355,其具有开口宽度390。在开口355近侧的位置357处,通道350具有比开口宽度390大的宽度392。这为通道350提供了允许与第一刀片状物241的对应部分滑动接合的横截面形状。在示例性实施方案中,第一通道350和第二通道352构造成具有燕尾形横截面形状。然而,在其它实施方案中,可以使用其它各种横截面形状,这将有助于与对应形状的部分进行类似的滑动接合连接。换句话说,在其它实施方案中,可以使用刀片状物和刀片状物致动构件的任何几何形状,其中刀片状物和刀片状物致动构件包括某种对应的配合表面。
在一些实施方案中,刀片状物接合部分322可以在上表面和下表面处被设定轮廓,以抵抗下沉并允许最大刀片状物展开深度。这种几何形状也帮助保持刀片状物接合部分322在椎骨终板之间居中。作为一个示例,在本实施方案中上表面330和下表面332的轮廓在图10的放大横截面图中最佳地看出。
图10-图11分别图示了刀片状物致动构件260和一组刀片状物240的示意性分解等距图和示意图。参照图10-图11,第一刀片状物241的突出部分450配合到第一通道350中。同样,第二刀片状物242的突出部分455配合到第二通道352中。
每个通道可以与第一通道方向和相反的第二通道方向相关联。例如,如图9最佳地看出的,第一通道350可以与沿第一通道350的长度指向上表面330的第一通道方向460相关联。同样,第一通道350包括沿第一通道350的长度指向下表面332的第二通道方向462。
在第一刀片状物241的第一突出部分450布置在第一通道350中的情况下,第一突出部分450可以在第一通道方向460或第二通道方向462上滑动。当第一突出部分450在第一通道方向460上滑动时,第一刀片状物241相对于刀片状物致动构件260竖直移动,使得第一刀片状物241在植入物的上侧面上向外延伸(见图6-图7)。当第一突出部分450在第二通道方向462上滑动时,第一刀片状物241相对于刀片状物致动构件260竖直移动,使得第一刀片状物241缩回到植入物100的外部结构201内(见图4-图5)。以类似的方式,第二刀片状物242的第二突出部分455可以在第二通道352的第一通道方向和第二通道方向上滑动,使得第二刀片状物242可以在下侧面上从植入物100延伸和缩回(见图4-图7)。通过使用这种构造,刀片状物致动构件260在相反方向上推进两个刀片状物,从而平衡反作用载荷并最小化悬臂载荷和导引杆上的摩擦。
如图11的横截面中所示,每个刀片状物和刀片状物致动构件260中的相应通道之间的配合可以构造成抵抗在正交于对应通道方向的方向上的运动。例如,当第一突出部分450插入第一通道350内时,第一刀片状物241可以沿第一通道方向460或第二通道方向462平移,但是不可以在垂直于第一通道方向460和第二通道方向462的方向465上移动(即,刀片状物241不可以在垂直于第一通道350长度的方向上平移)。具体地,如之前提到的,第一通道350和第一突出部分450的对应横截面形状使得第一突出部分450不可以配合穿过刀片状物致动构件260的第一侧表面334上的第一通道350中的开口。
在一些实施方案中,每个突出部分与对应的通道形成滑动燕尾连接或接合。在刀片状物致动构件上使用燕尾轨道以及在后刀片状物和前刀片状物上使用对应的燕尾特征允许沿倾斜角轴向移动,同时防止在刀片状物撞击和缩回期间在遇到的载荷下脱离。例如,在图11中,第一突出部分450与第一通道350形成滑动燕尾接合。当然,实施方案不限于燕尾接合和其它配合/接合,其中可以使用通道中的开口,该开口小于刀片状物的突出部分的最宽部分。
可以理解,在其它实施方案中,刀片状物和刀片状物致动构件之间的互连部分的几何形状可以颠倒。例如,在另一个实施方案中,刀片状物可以包括一个或更多个通道,并且刀片状物致动构件可以包括对应的突出部以配合在通道中。在这样的实施方案中,刀片状物致动构件的突出部分和刀片状物中的通道均可以具有对应的燕尾几何形状。
主体和帽
图12图示了主体200的示意图。主体200可以提供外部结构201的后侧面和前侧面,以及外部结构201的至少一个侧向面。
在一些实施方案中,主体的后侧面和前侧面均可以具有桁架状或格子状几何形状。在其它实施方案中,后侧面和/或前侧面可以构造成为具有一个或更多个开口的实心壁。在图12所示的示例性实施方案中,主体200的后侧面112和前侧面110具有包括对角定向的支撑件500的桁架状几何形状。尽管图12中示出了支撑件的特定图案,但是其它实施方案可以具有以任何其它图案布置的支撑件,包括任何桁架状和/或格子状图案。
关于图12的实施方案示出的支撑件500的构造可以有助于制造过程。特别地,通过将对角支撑件500相对于构建方向以大于45度定向,这种构造可以允许经由激光或电子束利用最小支撑结构进行3D打印。尽管图12的实施方案使用支撑件之间具有开口的桁架结构,但是其它实施方案可以包括薄壁材料以填充支撑件之间的开口中的一些。使用开口桁架设计和/或具有薄壁的桁架设计可以帮助提高X射线荧光透视下相邻骨骼解剖结构的可视性,同时仍然提供足够的结构支撑和刚性以承受所有测试要求和植入物的临床载荷。
在其它实施方案中,主体可以不具有桁架或格子状几何形状。例如,图15示出了主体550的可选设计。如图15中看出的,主体550在某些方面可以类似于主体200。然而,主体550不是具有桁架状几何形状,而是使用在前侧面和后侧面上均具有椭圆形开口552的实心几何形状。图中未示出的其它实施方案包括前侧面、后侧面或侧向面的其它形式的实心几何形状中的圆拱形(round)或矩形开口。
实施方案还可以包括一个或更多个刀片状物保持部分。刀片状物保持部分可以接纳刀片状物的任何部分,包括刀片状物的一个或更多个边缘和/或面。在一个实施方案中,主体包括刀片状物保持部分,以接纳每个刀片状物的侧向边缘。如图12中看出的,主体200包括后侧面112上的第一刀片状物保持部分600和第二刀片状物保持部分602。第一刀片状物保持部分600包括延伸穿过主体200的深度的第一刀片状物保持通道,该第一刀片状物保持通道接纳第一刀片状物241的第一侧向边缘404(见图8)。同样,第二刀片状物保持部分602包括延伸穿过主体200深度的第二刀片状物保持通道,该第二刀片状物保持通道接纳第一刀片状物241的第二侧向边缘406(见图8)。主体200还包括第三刀片状物保持部分604和第四保持部分606,用于接纳第二刀片状物242的侧向边缘。这种构造可以帮助最大化植入物内的可用的骨移植物体积,因为刀片状物的侧向边缘用作平移的轨道。具体而言,这限制了对刀片状物上的额外的轨道构件的需要,该额外的轨道构件将在植入物中占据额外的体积。此外,保持通道和相关刀片状物边缘的布置导致保持通道的体积的大部分由处于缩回位置的刀片状物边缘填充,这帮助防止任何移植物材料或BGPM(骨生长促进材料)进入保持通道并抑制正常的刀片状物行进。
图13和图14分别图示了帽220的远侧面和近侧面的等距视图。参照图13-图14,帽220包括一个或更多个开口,用于接合植入物100的不同部分。例如,帽220可以包括第一销孔227和第二销孔228,第一销孔227和第二销孔228构造成分别接纳销291和销292(见图3)。此外,帽220的第一销孔227和第二销孔228(图13和图14中所示)可以与主体中的对应孔对齐。
如前讨论的,帽220可以包括开口224,以接纳锁定螺钉或其它紧固件。此外,帽220可以包括接纳刀片状物致动构件260的一部分的导引开口222。在一些实施方案中,导引开口222可以具有与刀片状物致动构件的从动部分的横截面形状相匹配的形状。在一些实施方案中,导引开口222和刀片状物致动构件260的从动轴部分320均具有矩形横截面形状。这种构造可以允许轴向运动,但是控制刀片状物撞击期间可能产生的旋转载荷和角度载荷,如图13-图14中例示的。
在一些实施方案中,帽220可以包括用于插入器械的附接点。例如,如图13-图14中看出的,帽220可以包括第一空腔580和第二空腔582,第一空腔580和第二空腔582可以接纳插入工具的端部,以在插入脊柱的椎骨之间(或从脊柱的椎骨之间移除)期间改善工具对植入物100的抓持。
如在图14中看出的,在一些实施方案中,帽220还可以包括用于接纳主体200的一部分的空腔570。具体而言,空腔570可以接纳主体200的紧固端部576(见图12),紧固端部576包括图12中所示的销接纳开口578,使得在图2中所示的装配但未展开状态中,一旦第二销292已经插入,紧固端部576可以保持在空腔570内。
三点附接
图16是植入物100的示意性俯视图,其中刀片状物和植入物100的其它部件之间的附接是可见的。图17是植入物100的区域650的示意性放大图,其包括刀片状物致动构件260的一部分和第一刀片状物241,其中数个附接点清晰可见。
参考图16-图17,对于第一刀片状物241和第二刀片状物242中的每一个,植入物100使用三点附接构造。具体地,每个刀片状物沿其侧向边缘被两个刀片状物保持部分接纳,并且还利用上面描述的燕尾连接联接到刀片状物致动构件260。如在图16中看出的,第一刀片状物241的第一侧向边缘404被接纳在第一刀片状物保持部分600的第一刀片状物保持通道内。第一刀片状物241的第二侧向边缘406被接纳在第二刀片状物保持部分602的第二保持通道内。此外,第一刀片状物241的远侧面408保持不附接到植入物100的任何其它元件。不仅第一刀片状物241沿远侧面408保持不附接,而且在第一侧向边缘404和第二侧向边缘406之间的远侧面408的整体与植入物100的所有其它元件间隔开(即,不接触)。此外,第二刀片状物242同样在其侧向边缘处附接到对应的刀片状物保持部分,并且还使用滑动燕尾连接联接到刀片状物致动构件260。因此,第一刀片状物241和第二刀片状物242使用三点附接构造保持在植入物100中,该三点附接构造可以限制撞击期间第一刀片状物241和第二刀片状物242上的不需要的摩擦。可以理解,每个刀片状物和每个刀片状物保持通道之间的配合可以提供足够的间隙,以允许刀片状物沿保持通道平移。换句话说,配合可能不太紧以至于阻碍侧向边缘在保持通道内的移动。
在不同的实施方案中,一个或更多个刀片状物保持部分中的通道的横截面几何形状可以变化。在一些实施方案中,横截面几何形状可以是圆化(rounded)的。在图17所示的实施方案中,可以看出刀片状物保持部分600具有矩形刀片状物保持通道620。刀片状物轨道或通道的这种矩形几何形状和容差允许精确的轴向行进,而不受致动斜坡角度变化的束缚。类似地,图16-图17的实施方案的其余刀片状物保持部分具有类似的矩形形状。
在一些实施方案中,当刀片状物缩回时,每个刀片状物的侧向边缘可以保持在每个刀片状物保持部分的轨道或通道中,以防止骨移植材料限制刀片状物的自由展开。
滑动连接
使用诸如燕尾滑动接合的互锁接合来连接刀片状物和刀片状物致动构件帮助防止刀片状物在撞击期间与刀片状物致动构件分离。此外,通过互锁接合,刀片状物致动构件可用于缩回刀片状物。
图18-图21示出了在撞击序列期间(图18-图20)以及在缩回刀片状物的步骤期间(图21)植入物100的数个示意图。在图18-图21中,植入物100的外部结构201以虚线示出,以更好地示出刀片状物致动构件260、第一刀片状物241和第二刀片状物242。此外,图18-图21中的每一个都包括刀片状物致动构件260、第一刀片状物241和第二刀片状物242的截面的放大剖视图,以更好地示出致动期间这些部分之间的联接。
在图18中,植入物100处于插入位置,第一刀片状物241和第二刀片状物242完全缩回外部壳体201内。接下来,如在图19中看出的,撞击力700被施加到刀片状物致动构件260的从动端部262。当刀片状物致动构件260朝向植入物100的第二侧向面116平移时,刀片状物致动构件260分别沿第一通道350和第二通道352将力施加到第一刀片状物241和第二刀片状物242。具体地,第一通道350的定向使得第一刀片状物241朝向植入物100的上侧面被推动。同样,第二通道352的定向使得第二刀片状物242朝向植入物100的下侧面被推动。此外,第一突出部分450和第一通道350之间(以及第二突出部分455和第二通道352之间)的互锁连接意味着两个刀片状物始终保持与刀片状物致动构件260的运动相耦合。应当指出,由于两个刀片状物都被限制在纵向方向(即刀片状物致动构件260的运动方向)上移动,因此每个刀片状物的产生的运动完全是竖直的。此外,对每个刀片状物而言,使用燕尾形突出部分意味着突出部分均在中心线处升起,以限制可能导致对这些移动部分的运动的增加的(摩擦)阻力或增加对这些移动部分的束缚的任何翘曲力(cocking force)或旋转力矩。
使用这种构造,展开刀片状物的力通过刀片状物致动构件260被平衡,以便最小化从动轴部分320和帽220中的开口222(见图3)之间的摩擦和束缚,这帮助导引刀片状物致动构件260并保持其运动限于平行于纵向轴线(见图2)的方向。
在图20中,植入物100已经被放置在完全展开位置,第一刀片状物241和第二刀片状物242均从植入物100完全延伸。如在放大剖视图中看出的,当植入物100处于完全展开位置时,第一刀片状物241和第二刀片状物242均保持与刀片状物致动构件260联接。由于这种联接,刀片状物致动构件260的运动可以反向,以缩回第一刀片状物241和第二刀片状物242,如图21中所示。
参照图21,刀片状物致动构件260的从动端部262可以在与图19中所示运动相反的方向上被拉动。例如,在一些实施方案中,输送工具可以使用螺纹连接器联接到从动端部262。然后,当输送工具的末端缩回时,缩回力或拉动力710可以施加到从动端部262。当刀片状物致动构件260(并且特别是刀片状物接合部分322)朝向植入物100的第一侧向面114被拉动时,刀片状物致动构件260分别沿第一通道350和第二通道352将力施加到第一刀片状物241和第二刀片状物242。具体地,第一通道350的定向使得第一刀片状物241朝向植入物100的下侧面被推动。同样,第二通道352的定向使得第二刀片状物242朝向植入物100的上侧面被推动。尽管未示出,在从动端部262处施加足够的力可以导致第一刀片状物241和第二刀片状物242完全缩回,使得植入物100返回到图18中所示的插入位置。
锁定螺钉
图22-图24图示了根据一个实施方案的锁定螺钉280的数个示意图。锁定螺钉280包括凸缘头部282,凸缘头部282具有圆化区段(rounded segment)284和平坦区段286。锁定螺钉280还包括螺纹主体288和旋转限制凹槽289。
旋转限制凹槽289可以包括第一凹槽端部293和第二凹槽端部295(见图23)。如在图22-图24中看出的,旋转限制凹槽289可以围绕螺纹主体288的圆周延伸小于一整圈。
图25-图26图示了植入物的示意图,包括植入物100的等距视图和靠近植入物100的横断面截取的放大横截面视图。图25是植入物100的示意图,其中锁定螺钉280处于“解锁”旋转位置。在该解锁旋转位置,锁定螺钉280旋转,使得平坦区段286与开口222的相邻边缘对齐,从而允许刀片状物致动构件260的从动轴部分320无阻力地穿过开口222。
图26是植入物100的示意图,其中锁定螺钉280处于“锁定”旋转位置。在该锁定旋转位置,锁定螺钉280旋转,使得圆化区段284在开口222上延伸,并阻挡刀片状物致动构件260的从动端部262穿过开口222。可以理解,一旦从动端部262被完全推动穿过开口222并且邻近锁定螺钉280定位,则锁定螺钉280仅可以被放置在锁定旋转位置。
如在图26中看出的,销291可以布置在锁定螺钉280的旋转限制凹槽289(见图22-图24)内。此外,旋转限制凹槽289可以被设定大小和尺寸以允许锁定螺钉在锁定位置和解锁位置之间旋转,但是不旋转到完全退出植入物100的位置。例如,当销291接合在旋转限制凹槽289中时,锁定螺钉280可以仅在销291抵靠第一凹槽端部293布置的第一旋转位置和销291抵靠第二凹槽端部295布置的第二旋转位置之间旋转。
可以理解,在一些实施方案中,刀片状物致动构件(例如,刀片状物致动构件260)可以起到支撑相邻椎体的作用。这可以通过使用具有与外部支撑结构高度类似的高度的刀片状物致动构件来实现,使得刀片状物致动构件的上表面和下表面可以在植入后与椎体接触。由于刀片状物致动构件在植入物内用作承载载荷结构,因此这可以释放植入物内否则被额外支撑结构占据的额外空间,从而增加可用于骨移植物或BGPM的内部体积。
植入物尺寸
在不同的实施方案中,植入物的尺寸可以变化。在一些实施方案中,植入物可以具有任何长度。实施方案可以具有从40mm到60mm的长度范围。在某些情况下,制造商可以提供具有在40mm和60mm之间以5mm增量变化的长度的多种植入物选项。在一些实施方案中,植入物可以具有任何高度。实施方案可以具有从8mm到16mm的高度范围。在某些情况下,制造商可以提供具有从8mm到16mm以2mm增量变化的高度的植入物。实施方案可以具有18mm、22mm、26mm以及其它尺寸的宽度(即,沿前后轴线的尺寸)。
实施方案也可以构造成具有各种前凸(lordosis)角度,即后侧面和前侧面之间的倾斜角。实施方案可以构造成具有例如8度、15度和20度的前凸角度。在其它实施方案中,其它前凸角度可以用于植入物。
对齐特征
实施方案可以任选地包括一个或更多个对齐特征。示例性对齐特征包括但不限于用于荧光透视定位的窗口、用于刀片状物展开验证的窗口、用于将刀片状物致动构件与一个或更多个刀片状物对齐的窗口以及各种其它类型的对齐特征。参考图2,植入物100的主体200包括中心对齐窗口209。另外,刀片状物241包括对齐窗口297。当刀片状物241完全缩回时,对齐窗口297可以与中心对齐窗口209对齐。此外,刀片状物致动构件260包括第一对齐窗口277和第二对齐窗口279。当刀片状物241和刀片状物242完全展开和缩回时,窗口277和窗口279可以与植入物主体中心线对齐。这些窗口(即,中心对齐窗口209、第一对齐窗口277和/或第二对齐窗口279)中的一个或更多个可以有助于荧光透视定位,并且可以用于确认刀片状物展开。例如,在一些情况下,当第一刀片状物241和第二刀片状物242完全展开时,刀片状物可以使刀片状物致动构件260的第一对齐窗口277畅通(clear)。
一些实施方案还可以包括一个或更多个行程限制止动件。例如,图2中所示的植入物100的实施方案包括刀片状物致动构件260上的第一行程限制止动件283和第二行程限制止动件287。这些止动件可以帮助防止刀片状物致动构件260过度行进。具体地,止动件283和止动件287可以接触主体200的内表面。
材料
植入物的各部件可以由适合于植入人体中的生物相容性材料制成,包括但不限于金属(例如钛、钛合金、不锈钢、钴铬合金或其它金属)、合成聚合物(例如,PEEK或PEKK)、陶瓷和/或它们的组合,取决于特定应用和/或医疗从业者的偏好。
通常,植入物可以由具有足够强度的任何合适的生物相容的、不可降解的材料形成。典型的材料包括但不限于钛、生物相容的钛合金(例如钛铝化物(包括γ钛铝化物)、Ti6-Al4-V ELI(美国材料试验标准F 136和美国材料试验标准F 3001)或Ti6-Al4-V(美国材料试验标准F 1108、美国材料试验标准F 1472和美国材料试验标准F 2989)以及惰性、生物相容的聚合物,例如聚醚醚酮(PEEK)(例如因维生物(Invibio)公司,苏威(Solvay)公司或其它)。任选地,植入物包含不透射线的标记,以当由射线可透过生物材料构造时在成像期间有助于可见性。
在不同的实施方案中,制造植入物的过程可以变化。在一些实施方案中,整个植入物可以经由传统的加工和CNC加工、注射成型、铸造或注射成型、嵌件成型、共挤出、拉挤成型、传递成型(transfer molding)、包覆成型(overmolding)、压缩成型、3维(3-D)打印、浸涂、喷涂、粉末涂覆、多孔涂覆、从固体原料研磨及其组合来制造和装配。
在一个实施方案中,主体200可以使用粉末Ti-6Al-4V ELI通过直接金属激光烧结(DMLS)来生产,并然后在特定位置进行传统加工或CNC加工以获得精确尺寸。此外,在一个实施方案中,刀片状物致动构件260、第一刀片状物241、第二刀片状物242、帽220、销290和锁定螺钉280也可以由包括钛的材料制成。
植入
一些实施方案可以使用骨生长促进材料,包括骨移植物或骨移植物替代材料。如本文中所用的,“骨生长促进材料”(BGPM)是帮助骨生长的任何材料。骨生长促进材料可以包括冷冻干燥到表面上或通过使用连结分子或结合剂粘附到金属的设置部。骨生长促进材料的示例是包括骨形态发生蛋白(BMP)(例如BMP-1、BMP-2、BMP-4、BMP-6以及BMP-7)的任何材料。这些是将干细胞转化成骨形成细胞的激素。进一步的示例包括重组的人类BMP(rhBMP),如rhBMP-2、rhBMP-4和rhBMP-7。更进一步的示例包括血小板衍生生长因子(PDGF)、成纤维细胞生长因子(FGF)、胶原蛋白、BMP模拟肽以及RGD肽。通常,也可以使用这些化学物质的组合。这些化学物质可以用海绵、基质或凝胶来施加。
一些骨生长促进材料也可以通过使用等离子喷涂或电化学技术施加至可植入假体。这些材料的示例包括但不限于羟基磷灰石、β三磷酸钙、硫酸钙、碳酸钙以及其它化学物质。
骨生长促进材料可以包括骨移植物或骨移植替代物,或者可以与骨移植物或骨移植替代物结合使用。多种材料可用作骨移植物或骨移植替代物,包括自体移植物(从患者身体的髂嵴采集)、同种异体移植物、脱矿骨基质和各种合成材料。
一些实施方案可以使用自体移植物。自体移植物提供了与钙胶原骨架的脊柱融合,以用于新骨生长(骨传导)。此外,自体移植物包含骨生长细胞、间充质干细胞和再生骨的成骨细胞。最后,自体移植物包含骨生长蛋白,包括骨形态发生蛋白(BMP),以培养患者体内的新骨生长。
骨移植替代物可以包括包含磷酸钙或羟基磷灰石的合成材料、含有干细胞的产品(其使干细胞与其它种类的骨移植替代物中的一种组合)、以及含有生长因子的基质,例如来自Medtronic公司的(含rhBMP-2的骨移植物)。
应当理解,这里列出的设置部并不意味着是可能的骨生长促进材料、骨移植物或骨移植替代物的详尽列举。
在一些实施方案中,BGPM可以施加至植入物的一个或更多个外表面。在其它实施方案中,BGPM可以施加至植入物内的内部体积。在其它实施方案中,BGPM可以施加至外表面和内部地施加至植入物内。
尽管已经描述了多种实施方案,但是本描述旨在是示例性的而不是限制性的,并且对于本领域普通技术人员来说将明显的是,在实施方案的范围内的许多更多的实施方案和实现方式是可能的。虽然在附图中显示并在本详细描述中讨论了特征的许多可能组合,但是所公开的特征的许多其它组合也是可能的。任何实施方案中的任何特征可以与任何其它实施方案中的任何其它特征或元件组合使用或取代任何其它实施方案中的任何其它特征或元件来使用,除非特别限制。因此,应理解,本公开中示出的和/或讨论的任何特征可以以任何合适的组合一起实现。因此,除了根据所附权利要求及其等同物之外,实施方案不受限制。而且,在所附的权利要求的范围内可以做出多种修改和改变。
本申请还涉及以下方面。
1).一种植入物,包括:
主体,所述主体具有第一轴线;
刀片状物,所述刀片状物具有在所述主体中的缩回位置和所述刀片状物从所述主体向外延伸的延伸位置;
刀片状物致动构件,其能够在平行于所述第一轴线的方向上穿过所述主体平移;
所述刀片状物致动构件包括通道,其中所述通道在所述刀片状物致动构件的上表面和下表面之间延伸,并且其中所述通道界定第一通道方向和相反的第二通道方向;
所述刀片状物包括构造成配合在所述通道内的突出部分;
其中当所述刀片状物致动构件沿所述第一轴线在第一方向上移动时,所述突出部分在所述第一通道方向上跟随所述通道,并且所述刀片状物朝向所述延伸位置移动;并且
其中当所述刀片状物致动构件在与所述第一方向相反的第二方向上移动时,所述突出部分在所述第二通道方向上跟随所述通道,并且所述刀片状物朝向所述缩回位置移动。
2).根据1)所述的植入物,其中,所述通道和所述刀片状物的所述突出部分在所述刀片状物致动构件和所述刀片状物之间形成滑动接合,并且其中所述滑动接合允许所述刀片状物相对于所述刀片状物致动构件沿所述第一通道方向或所述第二通道方向移动,并且其中所述滑动接合防止所述刀片状物在垂直于所述第一通道方向或所述第二通道方向的方向上移动。
3).根据1)所述的植入物,其中,所述通道和所述突出部分一起形成所述刀片状物致动构件和所述刀片状物之间的配合连接。
4).根据3)所述的植入物,其中,所述突出部分具有燕尾形横截面形状,其中所述通道具有燕尾形横截面形状,并且其中所述通道和所述突出部分一起形成滑动燕尾接合。
5).根据1)所述的植入物,其中,所述刀片状物具有外边缘、内边缘、第一侧向边缘和第二侧向边缘,并且其中所述刀片状物仅沿所述第一侧向边缘和所述第二侧向边缘与所述主体接触。
6).根据5)所述的植入物,其中,所述主体包括用于保持所述第一侧向边缘的第一保持通道,并且其中所述主体包括用于保持所述第二侧向边缘的第二保持通道,并且其中所述第一保持通道和所述第二保持通道定向成与所述第一轴线成非零角度。
7).一种植入物,包括:
主体,所述主体具有第一轴线;
刀片状物,所述刀片状物具有在所述主体中的缩回位置和所述刀片状物从所述主体向外延伸的延伸位置;
所述刀片状物具有外边缘、内边缘、第一侧向边缘和第二侧向边缘;
所述刀片状物还具有远侧面和近侧面;
其中所述刀片状物的所述第一侧向边缘和所述刀片状物的所述第二侧向边缘与所述主体接触;
刀片状物致动构件,其能够在平行于所述第一轴线的方向上穿过所述主体平移;
其中所述刀片状物的所述近侧面的一部分与所述刀片状物致动构件接触;
其中所述刀片状物的所述远侧面远离所述主体布置;并且
其中所述刀片状物致动构件能够在所述缩回位置和所述延伸位置之间移动所述刀片状物。
8).根据7)所述的植入物,其中,所述主体包括第一保持通道和第二保持通道,其中所述刀片状物的所述第一侧向边缘接纳在所述第一保持通道中,并且其中所述刀片状物的所述第二侧向边缘接纳在所述第二保持通道中。
9).根据7)所述的植入物,其中,所述刀片状物具有第一弯曲部,第一刀片状物部分和第二刀片状物部分在所述第一弯曲部处以非零角度会合。
10).根据7)所述的植入物,其中,所述刀片状物致动构件通过滑动接合联接到所述刀片状物。
11).根据10)所述的植入物,其中,所述刀片状物致动构件包括通道,并且其中所述刀片状物包括配合在所述通道内的突出部分。
12).根据11)所述的植入物,其中,所述刀片状物致动构件中的所述通道和所述突出部分一起形成滑动燕尾接合。
13).根据12)所述的植入物,其中,所述刀片状物致动构件中的所述通道在所述刀片状物致动构件的一侧上对角地延伸。
14.)根据7)所述的植入物,其中,所述刀片状物致动构件包括对齐窗口,所述对齐窗口用于指示所述刀片状物何时已经完全展开。
15).一种植入物,包括:
外部结构,所述外部结构具有第一轴线;
刀片状物,所述刀片状物具有在所述外部结构中的缩回位置和所述刀片状物从所述外部结构向外延伸的延伸位置;
刀片状物致动构件,其能够在平行于所述第一轴线的方向上穿过所述外部结构平移;
其中所述刀片状物致动构件联接到所述刀片状物,并且能够在所述缩回位置和所述延伸位置之间移动所述刀片状物;
所述外部结构包括具有螺纹开口和邻近所述螺纹开口的导引开口的第一端部,所述导引开口接纳所述刀片状物致动构件的从动端部;
锁定螺钉,其固定在所述螺纹开口内;
其中所述锁定螺钉能够在解锁旋转位置和锁定旋转位置之间旋转,在所述解锁旋转位置,所述刀片状物致动构件的所述从动端部能够穿过所述导引开口,在所述锁定旋转位置,所述刀片状物致动构件的所述从动端部被阻止移动穿过所述导引开口。
16).根据15)所述的植入物,其中,所述锁定螺钉包括螺纹部分和凸缘部分,其中所述凸缘部分包括圆化区段和平坦区段。
17).根据16)所述的植入物,其中,在所述解锁旋转位置,所述平坦区段与所述导引开口的边缘对齐,并且其中在所述锁定旋转位置,所述圆化区段布置在所述导引开口的边缘上方。
18).根据15)所述的植入物,其中:
所述外部结构包括主体和帽;
其中所述植入物还包括延伸穿过所述主体和所述帽并帮助将所述主体固定到所述帽的销;
其中所述锁定螺钉的螺纹部分包括旋转约束凹槽;
其中所述旋转约束凹槽包括第一凹槽端部和第二凹槽端部;并且
其中所述旋转约束凹槽围绕所述螺纹部分的圆周延伸少于一整圈。
19).根据18)所述的植入物,其中,所述销部分地延伸穿过所述主体的所述螺纹开口并且接合所述旋转约束凹槽。
20).根据19)所述的植入物,其中,所述锁定螺钉被约束成在第一旋转位置和第二旋转位置之间旋转,所述第一旋转位置是所述销邻近所述第一凹槽端部布置的位置,并且所述第二旋转位置是所述销邻近所述第二凹槽端部布置的位置。
Claims (10)
1.一种植入物,包括:
主体,所述主体具有第一轴线;
刀片状物,所述刀片状物具有在所述主体中的缩回位置和所述刀片状物从所述主体向外延伸的延伸位置;
所述刀片状物具有外边缘、与所述外边缘相对布置的内边缘、第一侧向边缘、与所述第一侧向边缘相对布置的第二侧向边缘、远侧面以及近侧面;
其中所述刀片状物的所述第一侧向边缘和所述刀片状物的所述第二侧向边缘与所述主体接触;
刀片状物致动构件,其能够在平行于所述第一轴线的方向上穿过所述主体平移;
其中所述刀片状物的所述近侧面的一部分与所述刀片状物致动构件接触;
其中所述刀片状物的所述远侧面远离所述主体布置;并且
其中所述刀片状物致动构件能够在所述缩回位置和所述延伸位置之间移动所述刀片状物;
其中所述主体包括第一保持通道和与所述第一保持通道相对布置的第二保持通道,其中所述刀片状物的所述第一侧向边缘被接纳在所述第一保持通道中,并且其中所述刀片状物的所述第二侧向边缘被接纳在所述第二保持通道中。
2.根据权利要求1所述的植入物,其中,所述刀片状物仅沿所述第一侧向边缘和所述第二侧向边缘与所述主体接触。
3.根据权利要求1所述的植入物,其中,所述刀片状物具有第一弯曲部,第一刀片状物部分和第二刀片状物部分在所述第一弯曲部处以非零角度会合。
4.根据权利要求1所述的植入物,其中,所述刀片状物致动构件通过滑动接合联接到所述刀片状物。
5.根据权利要求4所述的植入物,其中,所述刀片状物致动构件包括通道,并且其中所述刀片状物包括配合在所述通道内的突出部分。
6.根据权利要求5所述的植入物,其中,所述刀片状物致动构件中的所述通道和所述突出部分一起形成滑动燕尾接合。
7.根据权利要求6所述的植入物,其中,所述刀片状物致动构件中的所述通道在所述刀片状物致动构件的一侧上对角地延伸。
8.根据权利要求1所述的植入物,其中,所述刀片状物致动构件包括对齐窗口,所述对齐窗口用于指示所述刀片状物何时已经完全展开。
9.一种植入物,包括:
外部结构,所述外部结构具有第一轴线;
刀片状物,所述刀片状物具有在所述外部结构中的缩回位置和所述刀片状物从所述外部结构向外延伸的延伸位置;
刀片状物致动构件,其能够在平行于所述第一轴线的方向上穿过所述外部结构平移;
其中所述刀片状物致动构件联接到所述刀片状物,并且能够在所述缩回位置和所述延伸位置之间移动所述刀片状物;
所述外部结构包括具有螺纹开口和导引开口的第一端部,所述螺纹开口具有第一纵向轴线,所述导引开口邻近所述螺纹开口并且具有与所述第一纵向轴线不对齐的第二纵向轴线,所述导引开口接纳所述刀片状物致动构件的从动端部;
锁定螺钉,其固定在所述螺纹开口内;
其中所述锁定螺钉能够在解锁旋转位置和锁定旋转位置之间旋转,在所述解锁旋转位置,所述刀片状物致动构件的所述从动端部能够穿过所述导引开口,在所述锁定旋转位置,所述刀片状物致动构件的所述从动端部被阻止移动穿过所述导引开口。
10.根据权利要求9所述的植入物,其中,所述锁定螺钉包括螺纹部分和凸缘部分,其中所述凸缘部分包括圆化区段和平坦区段。
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2016
- 2016-10-18 US US15/296,902 patent/US10307265B2/en active Active
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2017
- 2017-10-17 BR BR112019008016A patent/BR112019008016A2/pt not_active Application Discontinuation
- 2017-10-17 EP EP17863072.9A patent/EP3528753A4/en active Pending
- 2017-10-17 JP JP2019520880A patent/JP7054695B2/ja active Active
- 2017-10-17 WO PCT/US2017/056973 patent/WO2018075511A1/en unknown
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- 2017-10-17 CN CN202111283181.XA patent/CN113952086A/zh active Pending
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2019
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2022
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- 2022-04-04 JP JP2022062252A patent/JP7470731B2/ja active Active
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CN110381891B9 (zh) | 2022-02-08 |
US20180104068A1 (en) | 2018-04-19 |
JP7054695B2 (ja) | 2022-04-14 |
BR112019008016A2 (pt) | 2019-07-09 |
US11877935B2 (en) | 2024-01-23 |
US10307265B2 (en) | 2019-06-04 |
CN110381891B (zh) | 2021-12-10 |
US20190282372A1 (en) | 2019-09-19 |
JP7470731B2 (ja) | 2024-04-18 |
JP2019535360A (ja) | 2019-12-12 |
WO2018075511A1 (en) | 2018-04-26 |
EP3528753A1 (en) | 2019-08-28 |
EP3528753A4 (en) | 2020-10-28 |
US11246716B2 (en) | 2022-02-15 |
CN110381891A (zh) | 2019-10-25 |
US20220133494A1 (en) | 2022-05-05 |
JP2022079754A (ja) | 2022-05-26 |
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