CN101031260A - 用于结构支持的具有互锁几何形状的可扩张脊柱植入物 - Google Patents
用于结构支持的具有互锁几何形状的可扩张脊柱植入物 Download PDFInfo
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- CN101031260A CN101031260A CNA2005800247183A CN200580024718A CN101031260A CN 101031260 A CN101031260 A CN 101031260A CN A2005800247183 A CNA2005800247183 A CN A2005800247183A CN 200580024718 A CN200580024718 A CN 200580024718A CN 101031260 A CN101031260 A CN 101031260A
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- implant
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- spinal implant
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- groove
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Abstract
一种可扩张脊柱植入物(20),该植入物包括大致沿纵轴线(L)延伸的至少两个可扩张分支部分(24,26),它们各自包括固定端部和相对的活动端部,固定端部在植入物基部(28)附近连接在一起。第一分支部分包括具有相对的轴向外表面(66)的至少一个横向突起。第二分支部分包括具有相对的轴向内表面(68)的至少一个横向凹槽(64a)。横向突起位于横向凹槽内并可沿横向凹槽位移,突起的外表面紧密贴合凹槽内表面,以赋予植入物扩张后的结构支持。在一个实施方式中,分支部分通过至少一个裂隙(60)而相互分离,裂隙包括狭窄部分,该狭窄部分具有紧密匹配横向突起和凹槽。
Description
技术领域
本发明一般涉及可扩张脊柱植入物领域,更具体地涉及用于结构支持的具有互锁几何形状的可扩张脊柱植入物。
背景技术
已进行了许多尝试来开发一种脊柱植入物,代替受损或退化的天然脊椎盘并维持相邻椎骨间足够的椎间盘间隙稳定性,至少维持到完成关节融合术。这些类型的脊椎植入物具有许多形式。
例如,一些脊柱植入物被设计成可恢复和/或维持相邻椎骨间的天然解剖学角度。为实现该目的,一些植入物设计包括多分支,这些分支具有固定端和活动端,固定端附连或连接在一起,活动端保持独立,从而使活动端可相互扩张开来,提供给植入物对应于相邻椎骨间天然解剖学角度的选定锥度。植入物的扩张通常依赖于扩张元件或楔形件沿分支限定的锥形内表面的轴向位移。这种植入物设计的一个例子如Liu等的美国专利6,436,140所述,该专利的内容被结合于此作为参考。
可扩张脊柱植入物通常依赖于允许植入物某些部分的材料变形的较细长或纤弱的结构或特征,这些结构和特征又能促进植入物沿一个或多个方向扩张。但是,允许材料变形的细长或纤弱特征倾向于损伤植入物的结构完整性并降低负荷耐受性,尤其是相邻椎骨施加在脊椎植入物上的屈曲和剪切负荷耐受性。因此,脊椎植入物中包含有利于扩张的特征会降低植入物总的结构完整性。
因此,行业中一般需要提供一种改进的可扩张脊柱植入物。本发明满足了这种需要并以新颖和非显而易见的方式提供了其它益处和优点。
发明内容
本发明一般涉及一种可扩张脊柱植入物。虽然仅能参考所附权利要求书确定本文所覆盖的本发明的实际性质,但以本文所述优选实施方式为特征的本发明的某些形式简要描述如下。
在本发明的一种形式中,提供了一种可扩张脊柱植入物,它包括大致沿第一和第二端部之间的纵轴线延伸的主体,主体具有从第一端部朝第二端部延伸的至少一个裂隙,以使主体具有在第二端部附近连接在一起的至少两个可扩张分支部分。裂隙包括在分支部分间形成紧密匹配互锁结构的狭窄部分,以赋予植入物扩张后的结构支持。
在本发明的另一种形式中,提供了一种可扩张脊柱植入物,它包括至少两个可扩张分支部分,它们大致沿纵轴线延伸且各自包括固定端部和相对的活动端部,各个固定端部在植入物的固定基部附近连接在一起。第一分支部分包括具有相对轴向外表面的至少一个横向突起,第二分支部分包括具有相对轴向内表面的至少一个横向凹槽。横向突起位于横向凹槽内且可沿横向凹槽位移,突起的外表面紧密贴合各个凹槽内表面,以赋予植入物扩张后的结构支持。
在本发明的另一种形式中,提供了一种可扩张脊柱植入物,它包括至少两个可扩张分支部分,它们大致沿纵轴线延伸且各自包括固定端部和相对的活动端部,各个固定端部在植入物的固定基部附近连接在一起。第一分支部分包括适合与相邻椎骨相啮合的第一骨啮合表面,并形成横向于所述第一骨啮合表面排列的至少一个突起。第二分支部分包括适合与相邻椎骨相啮合的第二骨啮合表面,并形成横向于所述第二骨啮合表面排列的至少一个凹槽。突起位于凹槽内并可沿凹槽位移,以赋予植入物扩张后的结构支持。
在本发明的另一种形式中,提供了一种可扩张脊柱植入物,它包括至少两个分支部分,它们大致沿纵轴线延伸且连接在一起以实现它们之间围绕枢转轴线的相对枢转运动。第一分支部分包括至少一个突起,突起具有大致沿相对于枢转轴线的径向弧延伸的外表面。第二分支部分包括至少一个凹槽,凹槽具有大致沿径向弧延伸的内表面。突起位于凹槽内并可沿凹槽位移,突起外表面紧密贴合凹槽内表面,以赋予脊柱植入物扩张后的结构支持。
在本发明的另一种形式中,提供了一种可扩张脊柱植入物,它包括至少两个可扩张分支部分,它们大致沿纵轴线延伸且各自包括固定端部和相对的活动端部,各个固定端部在植入物的固定基部附近连接在一起。植入物的固定基部具有背对分支部分的外表面并形成凹曲度以便植入物的横向扩张。
本发明的一个目的是提供一种改进的可扩张脊柱植入物。本文所包含的附图和说明将使本发明的其它特征、优点、益处和方面显而易见。
附图说明
图1是根据本发明一种形式的可扩张脊柱植入物的侧视图,所示为非扩张状态。
图2是图1所示可扩张脊柱植入物的端视图。
图3是沿图2中的线3-3得到的图2所示可扩张脊柱植入物的横截面图。
图4是图1所示可扩张脊柱植入物的侧视图,所示为扩张状态。
图5是根据本发明另一种形式的可扩张脊柱植入物的侧视图,所示为非扩张状态。
图6是图5所示可扩张脊柱植入物的侧视图,所示为扩张状态。
图7是根据本发明另一种形式的可扩张脊柱植入物的侧视图。
图8是根据本发明另一种形式的可扩张脊柱植入物的侧视立体图。
图9是根据本发明另一种形式的可扩张脊柱植入物的侧视图,所示为非扩张状态。
图10是图9所示可扩张脊柱植入物的侧视图,所示为扩张状态。
具体实施方式
为了促进对本发明原理的理解,现在将参考附图所示实施方式并使用具体语言来描述这些实施方式。但是,应理解,这里并不限制本发明的范围,并且认为包括所示装置的变化和进一步改进,以及本文所述本发明原理的进一步应用,是本发明所属领域技术人员通常所理解的那样。
参考图1,其中显示了根据本发明一种形式的可扩张脊柱植入物20。脊柱植入物20沿纵轴线L延伸,被构造成通常沿横轴线T扩张,以分离椎间盘间隙和/或恢复或维持相邻椎骨间的脊柱前凸。然而,应理解,脊柱植入物20可在多个方向上沿多根轴线扩张。一扩张机构用于使脊柱植入物20从图1所示初始构型朝图4所示扩张构型转变。关于脊柱植入物20的扩张的进一步细节如下所述。
脊柱植入物20优选由生物相容材料构成。在一个实施方式中,脊柱植入物20由医用级合金如钛形成。然而,也可考虑使用其它金属材料,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、或任意组合的金属材料。此外,应理解,也可考虑由非金属材料形成脊柱植入物20。例如,在另一些实施方式中,脊柱植入物20可由聚合物材料形成,包括例如,非吸收性聚合物如聚醚醚酮(PEEK)或吸收性聚合物如聚乳酸酯(PLA)。在另一些实施方式中,脊柱植入物20可由骨或骨替代材料形成。形成脊柱植入物20的其它合适的材料的例子包括:复合材料聚合物、非增强型聚合物、碳增强型聚合物复合材料、碳纤维、PMMA、氢氧化钙、陶瓷、聚丙交酯、聚乙交酯、酪氨酸衍生的聚碳酸酯、聚酐、聚正酯、聚磷腈、磷酸钙、氢氧化钙、羟基磷灰石、生物活性玻璃、或这些材料的任意组合。
脊柱植入物20包括近端部分22a和远端部分22b。在一个实施方式中,脊柱植入物20通常由上分支部分24和下分支部分26组成,它们各自基本沿纵轴线L延伸并通过固定基部28在邻近近端部分22a处相互连接。然而,应理解,脊柱植入物20可形成任意数量的分支部分,包括三个、四个、或五个或更多个分支部分。如下所述,促动扩张机构可使分支部分24,26分离或扩张开来,使得脊柱植入物20邻近远端部分22b的截面尺寸大于邻近近端部分22a的截面尺寸。
在所示实施方式中,分支部分24,26与固定基部28连接的方式为可使分支部分24,26相互运动,从而扩张脊柱植入物20。在一个实施方式中,脊柱植入物20的扩张是由分支部分24,26围绕位于邻近近端部分22a的固定基部28沿线的枢转轴线P的相对枢转运动造成的。然而,分支部分24,26之间其它类型的相对运动也被认为落在本发明的范围内。在另一个实施方式中,固定基部28较薄或较细长,具有预定的构型,该构形以预定和重复方式提供受控制的变形或弯曲。在这种方式中,通过控制枢转轴线P的定位及上下分支部分24,26的相对取向和定位,可相应地控制脊柱植入物20扩张。在所示实施方式中,固定基部28具有弯曲或弓状构型,该构形形成凹形外表面29以便于脊柱植入物20的扩张并提供对脊柱植入物20扩张特征的一定程度的控制。然而,固定基部28的其它构型也被认为落在本发明的范围内。
在本发明的一个实施方式中,分支部分24,26与基部28整体形成,产生单件式整体脊柱植入物20。这样,基部28与分支部分24,26柔性互连,以允许脊柱植入物20通过分支部分24,26和/或固定基部28的柔性材料变形而扩张。固定基部28与分支部分24,26间的互连结构在脊柱植入物20扩张期间以类似铰链的方式起作用,使分支部分24,26基本上独立运动。虽然所示实施方式的脊柱植入物20采用整体连接的分支部分24,26,但也可考虑分支部分24,26独立形成且连接在一起以形成多件式植入物组合件。在另一个实施方式中,分支部分24,26通过铰链或枢转销可枢转地连接于基部28或直接相互连接,从而使得脊柱植入物20的扩张无需依赖柔性材料的变形。也可考虑将分支部分24,26连接在一起以提供脊柱植入物20的扩张的其它合适的方式,包括分支部分24,26相互直接形成或连接在一起而无需使用固定基部28。
在所示本发明实施方式中,脊柱植入物20响应于通常沿分支部分24,26间纵轴线L的扩张元件或楔形件30的轴向位移而扩张。扩张元件30的轴向位移又使分支部分24,26分离或扩张开,从而沿横轴线T扩张脊柱植入物20。具体地,如图3所示,扩张元件30沿分支部分24,26所限定的相对锥形表面32,34滑动位移,从而劈开分支部分24,26以沿横轴线T扩张脊柱植入物20。
在另一个实施方式中,锥形表面32,34在邻近植入物20的远端部分22b处形成保持元件或互锁结构36,它被构造成使扩张元件30保持或锁定在相对于脊柱植入物20的选定轴向位置并使脊柱植入物20维持在选定的扩张构型。在所示实施方式中,保持元件36包括一对相对的切口或凹槽38a,38b,它们的大小和形状适合将扩张元件30的对应部分接受于其中。在一个实施方式中,切口38a,38b具有盒状构型,该盒状构形形成相对的轴向表面以防止扩张元件30相对于植入物20轴向运动,并形成相对的侧向表面以防止扩张元件30相对于植入物20侧向运动。这样,将扩张元件30定位在切口38a,38b内也可用于耐受相邻椎骨施加在脊柱植入物20上的负荷,例如邻近植入物20远端部分22b的横向或侧向负荷及压缩负荷。虽然显示和描述了保持元件36包括一对切口38a,38b,应理解,也可考虑保持元件或互锁结构的其它类型和构型。例如,保持元件36可选地包括棘轮、内螺纹,或被构造成可啮合扩张元件30对应部分的其它合适的结构。
虽然显示和描述了脊柱植入物20响应扩张元件30沿分支部分24,26的轴向位移而扩张,应理解在本发明的其它实施方式中,也可利用扩张元件30相对于分支部分24,26的旋转或枢转位移使脊柱植入物20扩张。也可考虑可用于本发明的扩张元件30与分支部分24,26间其它类型的相对位移,包括例如,扩张元件24在横向于纵轴线L的方向上的位移。在另一个实施方式中,可提供器具或工具(未示出),其被构造成可啮合分支部分24,26并驱动分支部分24,26分开以沿横轴线T扩张脊柱植入物20。在本发明的又一个实施方式中,至少一部分脊柱植入物20可由形状记忆材料、如镍钛合金(Nitinol)形成,以为脊柱植入物20提供自扩张能力,从而消除了对独立的扩张元件或扩张器具的需要。
在所示实施方式的脊柱植入物20中,分支部分24,26形成具有基本扁平或平面构型的相对设置的上下骨啮合表面40,42,以及在骨啮合表面40,42间延伸、也具有基本扁平或平面构型的相对设置的侧表面44,46。在所示实施方式中,分支部分24,26相互配合形成大致矩形的外部截面。然而,应理解,脊柱植入物20和分支部分24,26的其它形状和构型也被认为落在本发明的范围内,包括例如弯曲或弓状构型、圆柱形构型、椭圆形构型、圆锥形构型、或本领域技术人员知道的任何其它合适的形状或构型。
在本发明又一个实施方式中,脊柱植入物20被构造成笼状构型,分支部分24,26相互配合,形成基本沿纵轴线L延伸的空心内部或通道50。然而,应理解,也可考虑脊柱植入物的其它实施方式,这些实施方式不形成空心内部而是形成基本实心的构型。骨生长促进材料、如骨形态生成蛋白(BMP)或其它类型的骨生长促进材料可位于脊柱植入物20的空心内部50中,以促进与相邻椎骨的融合。还可形成通过固定基部28的开口或通道52,以提供通往空心内部50的路径,从而将骨生长促进材料装载入空心内部50和/或接受器具或工具的端部通过其中以与扩张元件30相啮合而使脊柱植入物20转变为扩张构型。
虽然附图中未具体显示,在本发明的其它实施方式中,分支部分24,26各自具有延伸通过骨啮合表面40,42和/或侧表面44,46并与空心内部50连通的至少一个骨骼向内生长(bone in-growth)开口或窗口(未示出)。应理解,骨骼向内生长开口或窗口允许骨骼从相邻椎骨生长进入并有可能穿过脊柱植入物20。在本发明的其它实施方式中,骨啮合表面40,42可形成有许多骨锚定元件(未示出),这些元件适用于与相邻椎骨相啮合,从而一旦将脊柱植入物20植入椎间盘间隙内,这些锚定元件可防止或抑制脊柱植入物20的运动。在一个具体的实施方式中,骨锚定元件可包括沿脊柱植入物20长度的主要部分延伸的表面不规则结构。例如,可提供各种类型和构型的表面突起,包括例如,脊、齿、刺钉、螺纹、表面粗糙度、或本领域技术人员所知道的任何其它合适的骨锚定元件。
为了促进脊柱植入物20沿横轴线T的扩张,分支24,26通过从远端22b朝近端22a纵向延伸并终止于固定基部28附近的线状裂隙或通道60而相互分离。裂隙60侧向延伸通过脊柱植入物20,将脊柱植入物20分成两个分离的上分支部分和下分支部分24,26。在脊柱植入物20形成空心内部50的实施方式中,脊柱植入物20具有一对相对设置的裂隙60,它们从各个侧表面44,46延伸并与空心内部50连通。但是,在脊柱植入物20形成基本实心构型的实施方式中,脊柱植入物20具有在侧表面44,46间侧向延伸通过其中的单一裂隙。
在一个实施方式中,裂隙60终止于固定基部28附近的膨大裂隙部分66,以增加分支部分24,26与固定基部28之间的互连位置处的柔性,以便于脊柱植入物20转变为扩张构型,同时倾向于降低互连位置处可能产生的应力集中。膨大裂隙部分66也可用于接受器具或工具的对应部分,以便操纵和掌握脊柱植入物20。
在脊柱植入物20的所示实施方式中,裂隙60为大致沿纵轴线L延伸的起伏或波状构型,使得分支部分24,26形成位于对应数量凹槽或谷内中的许多突起或峰,突起和凹槽各自大致沿横轴线T延伸。如图1所示,裂隙60的形状和构型使得上分支部分24具有可嵌套入下分支部分26所限定的对应数量的凹槽或谷64a内的许多突起或峰62a。类似地,下分支部分24具有嵌套入上分支部分24所限定的对应数量的凹槽或谷64b内的许多突起或峰62b。这样,突起62a,62b以交叉或迷宫样方式嵌套在凹槽64a,64b内,其目的如下所述。
在一个具体的实施方式中,裂隙60的宽度w是窄的,以提供突起62a,62b的轴向表面66与对应凹槽64a,64b的轴向表面68之间相对紧密或协调配合。在其它实施方式中,轴向表面66,68各自大致沿相对于枢转轴线P的径向弧延伸。在这种方式中,当上下分支24,26在脊柱植入物20扩张期间分离或扩张开来时,相邻轴向表面66,68和相邻突起62a,62b不会相互干扰。虽然本文显示和描述了裂隙60的具体构型,应理解,其它合适的裂隙构型也被认为落在本发明的范围内。
参考图4,其中显示了扩张构型中的脊柱植入物20。如上所述,上、下分支部分24,26相对于枢转轴线P相互枢转位移,使脊柱植入物20从图1所示的初始非扩张构型转变为图4所示的扩张构型。此外,在脊柱植入物20扩张期间,突起62a,62b相对于枢转轴线P沿凹槽64a,64b径向位移。当转变为扩张构型时,骨啮合表面40,42相互倾斜,使脊柱植入物20具有对应于与椎间盘间隙(例如,相邻椎骨间的脊柱前凸角)相关的特定几何形状的构型。在一个实施方式中,骨啮合表面40,42具有落在0度到30度范围内的锥角A。在一个更具体的实施方式中,锥角A约为10度。但是,应理解,其它锥度A也被认为落在本发明的范围内。
随着脊柱植入物20转变为扩张构型,部分突起62a,62b以交叉或互锁方式保持在对应的凹槽64a,64b内,以向扩张的脊柱植入物20提供结构支持。应理解,突起62a,62b的轴向表面66与凹槽64a,64b的轴向表面68之间的啮合耐受脊柱植入物20沿纵轴线L方向的生理负荷,更具体地是相邻椎骨施加在脊柱植入物上的剪切负荷力Fs。此外,凹槽64a,64b啮合在突起62a,62b中还可耐受较薄的固定基部28响应相邻椎骨施加在脊柱植入物上的压缩负荷力Fc而发生的屈曲。应理解,突起62a,62b在凹槽64a,64b内的紧密协调和交叉匹配赋予脊柱植入物20结构支持,该结构支持可耐受生理剪切和屈曲负荷,而不明显妨碍或影响脊柱植入物20的扩张特征。
参考图5和6,其中显示了根据本发明另一种形式的可扩张脊柱植入物120。脊柱植入物120沿纵轴线L延伸,其结构类似于上文显示和描述的脊柱植入物20,它包括由固定基部128连接在一起的上和下分支部分124,126,分支部分124,126具有上和下骨啮合表面140,142。但是,与处于初始非扩张构型(图1)时初始基本相互平行排列的脊柱植入物20的骨啮合表面40,42不同,脊柱植入物120的骨啮合表面140,142在初始非扩张构型时(图5)相互倾斜。
如图5所示,当处于初始非扩张构型时,分支部分124,126的骨啮合表面140,142相对于纵轴线L倾斜,形成锥形构型的脊柱植入物120,以便将脊柱植入物120***椎间盘间隙和/或便于相邻椎骨的分离。在一个实施方式中,各骨啮合表面140,142相对于纵轴线L成角θ,以使脊柱植入物120具有初始总锥角α。在一个实施方式中,角θ落在0度到约15度的范围内,以使脊柱植入物120的初始总锥角α在0度到约30度之间。在一个更具体的实施方式中,角θ约为5度,以使脊柱植入物120的初始总锥角α约为10度。然而,应理解,其它角θ和初始总锥角α也被认为落在本发明的范围内。
如图6所示,当转变为扩张构型时,分支部分124,126的骨啮合表面140,142相互倾斜,以使脊柱植入物120具有对应于与椎间盘间隙(例如,相邻椎骨间的脊柱前凸角)相关的特定几何形状的构型。此外,除恢复和/或维持相邻椎骨间的脊柱前凸之外,脊柱植入物120的扩张还可用于分离椎间盘间隙。在一个实施方式中,骨啮合表面140,142相互倾斜,以使脊柱植入物120具有扩张锥角A。在一个具体的实施方式中,扩张锥角A落在0度到约30度的范围内。在另一个具体的实施方式中,扩张锥角A约为10度。但是,应理解,其它扩张锥角A也被认为落在本发明的范围内。
参考图7,其中显示了根据本发明另一种形式的可扩张脊柱植入物220。脊柱植入物220沿纵轴线L延伸,且结构上类似于上文显示和描述的脊柱植入物20,它包括近端部分222a、远端部分222b以及由固定基部228连接在一起的上、下分支部分224,226,该连接的方式可使分支部分224,226相互运动以大致沿横轴线L扩张脊柱植入物220。在所示实施方式中,脊柱植入物220的扩张是由分支部分224,226围绕位于固定基部228沿线的枢转轴线P的相对枢转运动造成的。但是,分支部分224,226之间的其它类型的相对运动也被认为落在本发明的范围内。在一个实施方式中,脊柱植入物220响应扩张元件230(虚线表示)沿分支部分224,226所限定的一对相对锥形表面232,234的轴向位移而扩张,从而劈开分支部分224,226以沿横轴线T扩张脊柱植入物220。此外,锥形表面232,234具有保持元件或凹槽236,它被构造成可使扩张元件保持或锁定在相对于脊柱植入物220的选定轴向位置中并使脊柱植入物220维持在选定的扩张构型中。
为了促进脊柱植入物220沿横轴线T的扩张,分支224,226通过从脊柱植入物220的远端222b朝近端222a纵向延伸并终止于固定基部228附近的线状裂隙或通道260而相互分离。裂隙260侧向延伸通过脊柱植入物220,将脊柱植入物220分成两个独立的上分支部分和下分支部分224,226。在所示实施方式中,裂隙260终止于固定基部228附近的膨大裂隙部分266,以增加分支部分224,226与固定基部228之间互连位置处的柔性,促进脊柱植入物220转变为扩张构型,同时倾向于降低互连位置处可能产生的应力集中。在一个实施方式中,裂隙260包括U形部分,该部分使分支部分224,226具有嵌套在对应凹槽264内的突起262,突起262和凹槽264大致沿横轴线T延伸。在所示实施方式中,裂隙260的形状和构型使上分支部分224具有凹槽264而下分支部分226具有突起262,然而,也考虑了相反的构型。突起262以交叉或迷宫样方式嵌套在凹槽264内。
在一个实施方式中,裂隙260的宽度w是窄的,以提供突起262的轴向表面266与凹槽264的轴向表面268之间相对紧密或协调配合。在其它实施方式中,轴向表面266,268各自大致沿相对于枢转轴线P的径向弧延伸。在这种方式中,当上下分支224,226在脊柱植入物220扩张期间分离或扩张开来时,相对轴向表面266,268不会相互干扰。虽然本文显示和描述了裂隙260的具体构型,应理解,其它合适的裂隙构型也被认为落在本发明的范围内。
应理解,在脊柱植入物220的扩张期间,突起262相对于枢转轴线P沿凹槽264径向位移。随着脊柱植入物220转变至扩张构型,一部分突起262以交叉或互锁方式保持在凹槽264内,以向扩张的脊柱植入物220提供结构支持。突起262的轴向表面266与凹槽264的轴向表面268之间的啮合可耐受脊柱植入物220沿纵轴线L的生理负荷,更具体是相邻椎骨施加在脊柱植入物中的剪切负荷力。此外,突起262在凹槽264中的啮合还可耐受较薄固定基部228响应相邻椎骨施加在脊柱植入物上的压缩负荷力而产生的屈曲。而且,突起262在凹槽264内的紧密协调和交叉匹配向脊柱植入物220提供结构支持,该结构支持可耐受生理剪切和屈曲负荷,而不明显妨碍或影响脊柱植入物220的扩张特征。
参考图8,其中显示了根据本发明另一种形式的可扩张脊柱植入物320。脊柱植入物320沿纵轴线L延伸并被构造成大致沿横轴线T扩张以分离椎间盘间隙和/或恢复或维持相邻椎骨间的脊柱前凸。然而,应理解,脊柱植入物320可在多个方向上沿多轴线扩张。在所示实施方式中,脊柱植入物320的扩张是由分支部分324,326围绕位于固定基部328沿线的枢转轴线P的相对枢转运动所引起的。但是,分支部分324,326之间其它类型的相对运动也被认为落在本发明的范围内。
在一个实施方式中,脊柱植入物320响应扩张元件(未示出)大致沿纵轴线L的轴线位移而扩张,而使分支部分324,326分离开来,以沿横轴线T扩张脊柱植入物320。此外,脊柱植入物320包括保持元件或阶梯结构336,它被构造成可啮合扩张元件以使脊柱植入物固定在选定的扩张构型。在所示实施方式中,保持元件336包括延伸通过上、下分支部分324,326的一对相邻开口338a,338b,这对开口的大小和形状为可接受扩张元件的对应部分于其中。扩张元件啮合和保持在各开口338a,338b内,并以递增方式分离上、下分支部分324,326,从而沿横轴线T逐步扩张脊柱植入物320。
在所示实施方式中,分支部分324,326具有各自基本扁平或平面构型的、相对设置的上下骨啮合表面340,342,以及在骨啮合表面340,342间延伸、也具有基本扁平或平面构型的相对设置的侧表面344,346。在一个实施方式中,分支部分324,326相互配合形成大致矩形的外部截面。然而,应理解,脊柱植入物320和分支部分324,326的其它形状和构型也被认为落在本发明的范围内。
在本发明的另一个实施方式中,分支部分324,326相互配合,形成基本沿纵轴线L延伸的空心内部或通道350。然而,应理解,也可考虑脊柱植入物的其它实施方式,其中不形成空心内部而是形成基本实心构型。骨生长促进材料可位于脊柱植入物320的空心内部350中,以促进与相邻椎骨的融合。此外,还可形成通过固定基部328的开口或通道352,以提供通往空心内部350的路径,从而将骨生长促进材料装载入空心内部350和/或接受器具或工具的端部通过其中并与扩张元件相啮合而使脊柱植入物320转变为扩张构型。脊柱植入物320可还具有开放远端353。此外,分支部分324,326各自具有至少一个骨骼向内生长开口或窗口354,这些开口或窗口354延伸通过骨啮合表面340,342并与空心内部350连通,以允许骨骼从相邻椎骨生长进入并有可能穿过脊柱植入物320。
在本发明的另一个实施方式中,骨啮合表面340,342可具有许多骨锚定元件,这些骨锚定元件适用于与相邻椎骨相啮合,使得一旦将脊柱植入物320植入椎间盘间隙内,这些锚定元件可防止或抑制脊柱植入物320的运动。在所示实施方式中,骨锚定元件可包括一系列槽356和一系列齿358。但是,应理解,也可考虑其它类型的骨锚定元件,例如脊、刺钉、螺纹、表面粗糙、或骨锚定元件的其它合适类型和构型。
为促进脊柱植入物320沿横轴线T的扩张,分支324,326通过从远端322b朝近端322a纵向延伸并终止于固定基部328附近的线状裂隙或通道360而相互分离。裂隙360侧向延伸通过脊柱植入物320,将脊柱植入物320分成两个独立的上分支部分和下分支部分324,326。在所示实施方式中,裂隙360终止于固定基部328附近的膨大裂隙部分366,以增加分支部分324,326与固定基部328之间互连位置处的柔性,促进脊柱植入物320转变为扩张构型,同时倾向于降低互连位置处可能产生的应力集中。此外,膨大裂隙部分366还提供了额外的通道,使骨骼向内生长进入空心内部350。膨大裂隙部分366也可用于接受器具或工具的对应部分,以便操纵和掌握脊柱植入物320。
在所示实施方式中,裂隙360包括U形部分,该部分使分支部分324,326具有嵌套在对应凹槽364内的突起362,突起362和凹槽364大致沿横轴线T延伸。在一个实施方式中,裂隙360的形状和构型可使上分支部分324具有凹槽364而下分支部分326具有突起362,然而,也考虑了相反的构型。突起362以交叉或迷宫样方式嵌套在凹槽364内。
在本发明的一个实施方式中,裂隙360的宽度w是窄的,以提供突起362的轴向表面366与对应凹槽364的轴向表面368之间相对紧密或协调配合。在另一个实施方式中,轴向表面366,368各自大致沿相对于枢转轴线P的径向弧延伸。在这种方式中,当上下分支324,326在脊柱植入物320扩张期间分离或扩张开来时,相对的轴向表面366,368不会相互干扰。虽然本文显示和描述了裂隙360的具体构型,应理解,其它合适的裂隙构型也被认为落在本发明的范围内。
应理解,在脊柱植入物320的扩张期间,突起362相对于设置轴线P沿凹槽364径向位移。随着脊柱植入物320转变至扩张构型,一部分突起362以交叉或互锁方式保持在凹槽364内,以向扩张的脊柱植入物320提供结构支持。突起362的轴向表面366与凹槽364的轴向表面368之间的啮合可耐受脊柱植入物320沿纵轴线L的生理负荷,更具体地是相邻椎骨施加在脊柱植入物上的剪切负荷力。此外,突起362在凹槽364中的啮合还可耐受较薄固定基部228响应相邻椎骨施加在脊柱植入物上的压缩负荷力而产生的屈曲。而且,突起362在凹槽364内的紧密协调和交叉匹配向脊柱植入物320提供结构支持,该结构支持可耐受生理剪切和屈曲负荷,而不明显妨碍或影响脊柱植入物320的扩张特征。
参考图9和10,其中显示了根据本发明另一种形式的可扩张脊柱植入物420。所示实施方式的脊柱植入物420沿纵轴线L延伸,并且其结构在许多方面类似于上文显示和描述的脊柱植入物320,它包括由固定基部428连接在一起的上、下分支部分424,426,该连接的方式允许脊柱植入物420大致沿横轴线T扩张。此外,为了促进脊柱植入物420沿横轴线T的扩张,分支424,426通过从脊柱植入物420的远端422b朝近端422a纵向延伸并终止于固定基部428附近的线状裂隙或通道460而相互分离。裂隙460侧向延伸通过脊柱植入物420,将脊柱植入物420分成两个独立的上、下分支部分424,426。
在所示实施方式中,裂隙460终止于固定基部428附近的膨大裂隙部分466,以增加分支部分424,426与固定基部428之间互连位置处的柔性,促进脊柱植入物420转变为扩张构型,同时倾向于降低互连位置处可能产生的应力集中。裂隙460包括U形部分,该部分使分支部分424,426具有嵌套在对应凹槽464内的突起462,突起462和凹槽464大致沿横轴线T延伸。在一个实施方式中,裂隙460的形状和构型使上分支部分424具有凹槽464而下分支部分426具有突起462,然而,也考虑了相反的构型。
突起462以交叉或迷宫样方式嵌套在凹槽464内。在所示实施方式中,突起462和凹槽464各自具有许多保持元件436,以使脊柱植入物420维持在选定的扩张构型。在一个实施方式中,保持元件436包括沿突起462横向形成的许多咬合元件或棘轮/推爪438a,以及沿凹槽464横向形成的许多咬合元件或棘轮/推爪438b。在另一个实施方式中,许多棘轮/推爪438a,438b沿各个突起462和凹槽464形成。然而,应理解,在其它实施方式中,突起462或凹槽464可具有单个棘轮/推爪438a,438b。
应理解,棘轮/推爪438a,438b可用作保持元件或互锁结构,以使脊柱植入物420保持或锁定在选定的扩张构型。还应理解,棘轮/推爪438a,438b相互配合以使上、下分支部分424,426在脊柱植入物420分级扩张期间位移分开,同时防止上、下分支部分424,426在扩张之后相互位移靠近,从而使脊柱植入物420维持在选定的扩张构型。虽然本文显示和描述了一个具体实施方式的保持元件436,应理解,也考虑了适用于使脊柱植入物420维持在选定的扩张构型的其它类型和构型的保持元件或互锁结构。
参考图10,在脊柱植入物420的扩张期间,突起462沿凹槽464位移,而一部分突起462保留在凹槽464内并且棘轮/推爪438a,438b以交叉或互锁方式啮合,以使脊柱植入物420维持在选定的扩张构型,并赋予扩张的脊柱植入物420结构支持。突起462在凹槽464中的啮合还可耐受脊柱植入物420沿纵轴线L的生理负荷,更具体地是相邻椎骨施加在脊柱植入物上的剪切负荷力。此外,突起462在凹槽464中的啮合还可耐受较薄固定基部428响应相邻椎骨施加在脊柱植入物上的压缩负荷力而产生的屈曲。而且,突起462在凹槽464内的紧密协调和交叉匹配赋予脊柱植入物420结构支持,该结构支持耐受生理剪切和屈曲负荷,而不明显妨碍或影响脊柱植入物420的扩张特征。
在一个实施方式中,扩张器或分离器型器具(未示出)具有分别与上、下分支部分424,426啮合的第一和第二末端部分,它们可用于在分支部分424,426上施加向外的力,以使植入物420转变至扩张构型。但是,也可使用其它装置和技术来扩张脊柱植入物420,例如,通过类似于上文脊柱植入物20中显示和描述扩张元件30的楔形扩张元件。
在本发明的一个实施方式中,由后路外科途径实现通往脊柱的通道并将脊柱植入物***椎间盘间隙。但是,应理解,也可通过其它外科途径实现通路和将脊柱植入物***椎间盘间隙,例如,前路途径或侧路途径。在本发明的另一个实施方式中,使用脊柱植入物来治疗脊柱腰椎区域。然而,应理解,本发明也适用于脊柱其它部位,包括脊柱颈部、胸部或骶部区域。此外,在本发明的另一个实施方式中,一对脊柱植入物可以双向排列方式并列位于椎间盘间隙内。然而,应理解,单个脊柱植入物在椎间盘间隙内的单向定位或中央定位也被认为落在本发明的范围内。
虽然在附图和上述说明中详细显示和描述了本发明,认为这些附图和说明是示例性而非限制性的,应理解,仅显示和描述了优选的实施方式,本发明精神范围内的所有变化和改进都需要保护。
Claims (31)
1.一种可扩张脊柱植入物,所述植入物包括:
大致沿第一和第二端部之间的纵轴线延伸的主体,所述主体形成大致沿所述纵轴线从所述第一端部朝所述第二端部延伸的至少一个裂隙,以使所述主体具有在所述第二端部附近连接在一起的至少两个可扩张分支部分,所述裂隙包括在所述分支部分间形成紧密匹配互锁结构的狭窄部分,以赋予所述植入物扩张后的结构支持。
2.如权利要求1所述的植入物,其特征在于,所述裂隙的所述狭窄部分形成与第一分支部分结合的至少一个横向突起和与第二分支部分结合的至少一个横向凹槽,所述横向突起位于所述横向凹槽内并可沿所述横向凹槽位移,以提供所述分支部分之间的紧密匹配互锁结构。
3.如权利要求2所述的植入物,其特征在于,所述横向突起形成相对的轴向外表面,所述横向凹槽形成相对的轴向内表面,所述横向突起的所述外表面紧密贴合各个所述横向凹槽的所述内表面,以赋予植入物扩张后的所述结构支持。
4.如权利要求2所述的植入物,其特征在于,所述分支部分在植入物扩张期间可围绕枢转轴线相互枢转位移,所述横向突起和所述横向凹槽形成具有类似的相对于所述枢转轴线的曲率半径的一对相邻表面。
5.如权利要求2所述的植入物,其特征在于,所述分支部分在所述主体的第二端部附近连接在一起,以允许它们之间围绕枢转轴线的相对枢转运动,所述横向突起大致沿相对于所述枢转轴线的径向弧延伸,所述横向凹槽也大致沿所述径向弧延伸。
6.如权利要求2所述的植入物,其特征在于,所述分支部分在所述主体的第二端部附近连接在一起,以允许它们之间围绕所述枢转轴线的相对枢转运动,所述横向突起具有大致沿相对于所述枢转轴线的径向弧延伸的外表面,所述横向凹槽具有大致沿所述径向弧延伸的内表面,所述横向突起的外表面紧密贴合所述横向凹槽的内表面,以赋予植入物扩张后的所述结构支持。
7.如权利要求2所述的植入物,其特征在于,所述第一分支部分包括适合与相邻椎骨相啮合的第一骨啮合表面,所述突起横向于所述第一骨啮合表面排列,所述第二分支部分包括适合与相邻椎骨相啮合的第二骨啮合表面,所述凹槽横向于所述第二骨啮合表面排列。
8.如权利要求7所述的植入物,其特征在于,当所述植入物处于非扩张***构型时,所述第一和第二骨啮合表面相互平行排列。
9.如权利要求7所述的植入物,其特征在于,当所述植入物处于非扩张***构型时,所述第一和第二骨啮合表面相互倾斜。
10.如权利要求2所述的植入物,其特征在于,所述横向突起和所述横向凹槽形成许多互锁保持元件,它们被构造成可使所述植入物维持扩张构型。
11.如权利要求10所述的植入物,其特征在于,所述互锁保持元件包括互锁棘轮元件。
12.如权利要求1所述的植入物,其特征在于,所述主体的第二端部具有背对所述分支部分的外表面,且该外表面形成凹曲度以便植入物的横向扩张。
13.如权利要求1所述的植入物,其特征在于,所述裂隙包括在所述主体第二端附近的膨大部分,以便植入物的横向扩张。
14.如权利要求1所述的植入物,其特征在于,所述裂隙的狭窄部分具有波状构型。
15.如权利要求1所述的植入物,其特征在于,所述裂隙的狭窄部分具有曲线构型。
16.如权利要求1所述的植入物,其特征在于,所述分支部分与所述主体的第二端部整体形成,以形成单件式整体植入物主体。
17.如权利要求1所述的植入物,其特征在于,至少一部分植入物由形状记忆材料形成,以使植入物具有自扩张能力。
18.如权利要求1所述的植入物,其特征在于,所述分支部分相配合以形成大小适合接受扩张元件于其中的内部通道;以及
所扩张元件在所述内部通道内的位移使所述扩张元件与所述分支部分相啮合以扩张所述植入物。
19.如权利要求18所述的植入物,其特征在于,所述位移包括所述扩张元件在所述内部通道内大致沿所述纵轴线的运动。
20.如权利要求18所述的植入物,其特征在于,所述分支部分具有限定所述内部通道的内表面,所述内表面相配合以形成沿所述纵轴线的锥形,所述扩张元件与所述内表面相啮合,使得当所述扩张元件大致沿所述纵轴线位移时,所述分支部分相互位移远离。
21.如权利要求18所述的植入物,其特征在于,所述分支部分中至少一个包括保持元件,所述保持元件适用于随着植入物的扩张而啮合所述扩张元件并使所述扩张元件保持在选定的位置。
22.如权利要求21所述的植入物,其特征在于,所述保持元件包括一对相对的切口,所述切口的大小和形状适合接受一部分所述扩张元件于其中。
23.如权利要求1所述的植入物,其特征在于,所述至少两个可扩张分支部分相配合以形成所述主体的空心内部;并且
还包括位于所述空心内部中的骨生长促进物质,以促进与相邻椎骨的融合。
24.如权利要求23所述的植入物,其特征在于,所述骨生长促进物质包括骨形态生成蛋白。
25.一种可扩张脊柱植入物,所述植入物包括:
大致沿纵轴线延伸的至少两个可扩张分支部分,所述分支部分连接在一起以允许它们之间围绕枢转轴线的相对枢转运动,第一分支部分包括至少一个突起,所述突起具有大致沿相对于枢转轴线的径向弧延伸的外表面,第二分支部分包括至少一个凹槽,所述凹槽具有大致沿所述径向弧延伸的内表面,所述突起位于所述凹槽内并可沿所述凹槽位移,使得所述突起的外表面紧密贴合所述凹槽的内表面,以赋予脊柱植入物扩张后的结构支持。
26.如权利要求26所述的植入物,其特征在于,所述分支部分各自包括固定端部和相对的活动端部,各所述固定端部在所述植入物的固定基部处连接在一起,以允许围绕所述枢转轴线的相对枢转运动。
27.如权利要求26所述的植入物,其特征在于,所述分支部分与所述固定基部整体形成,以形成单件式整体植入物主体。
28.如权利要求26所述的植入物,其特征在于,所述固定部分具有背对所述分支部分的外表面,且所述外表面形成凹曲度以促进围绕所述枢转轴线的所述相对枢转运动。
29.如权利要求25所述的植入物,其特征在于,所述分支部分通过至少一个裂隙而相互分离,所述至少一个裂隙包括狭窄部分,所述狭窄部分形成与所述第一分支部分结合的突起和与所述第二分支部分结合的凹槽。
30.如权利要求25所述的植入物,其特征在于,所述突起具有相对的轴向外表面,所述凹槽具有相对的轴向内表面,所述突起的外表面紧密贴合所述凹槽的内表面,以赋予所述植入物扩张后的结构支持。
31.如权利要求25所述的植入物,其特征在于,所述突起与所述第一分支部分整体形成,以形成单件式整体结构。
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Also Published As
Publication number | Publication date |
---|---|
CA2574039A1 (en) | 2006-02-02 |
JP2008507363A (ja) | 2008-03-13 |
US20100121453A1 (en) | 2010-05-13 |
EP1796600A1 (en) | 2007-06-20 |
US20060030943A1 (en) | 2006-02-09 |
US8303658B2 (en) | 2012-11-06 |
US7678148B2 (en) | 2010-03-16 |
JP4866350B2 (ja) | 2012-02-01 |
AU2005266925A1 (en) | 2006-02-02 |
WO2006012592A1 (en) | 2006-02-02 |
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