CN1997320B - 椎间垫片 - Google Patents
椎间垫片 Download PDFInfo
- Publication number
- CN1997320B CN1997320B CN2005800162700A CN200580016270A CN1997320B CN 1997320 B CN1997320 B CN 1997320B CN 2005800162700 A CN2005800162700 A CN 2005800162700A CN 200580016270 A CN200580016270 A CN 200580016270A CN 1997320 B CN1997320 B CN 1997320B
- Authority
- CN
- China
- Prior art keywords
- arm
- configuration
- pad
- arms
- implant
- 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
Links
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Images
Classifications
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- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
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Abstract
用于保持相邻棘突之间相互分离的垫片呈压扁和展开的构型。所述压扁的构型表示较小的轮廓,便于以最小的形状侵入式地植入垫片。示例的椎间垫片(10)包括块件(15)和臂(11、12、13和14)。当所述垫片呈松弛(展开)构型时,它类似于“H”形,臂11、12、13和14为“H”的分支,并且块件15为十字杆件。为了使用所述垫片,所述臂设计成与块件平行,使所述垫片缩成压扁(可植入)的构型。这使所述垫片呈现出“工”形,而不是“H”形。
Description
发明领域
本发明一般涉及用于治疗椎管狭窄的器件,更具体的是涉及可以最小侵入地方式植入、用于治疗椎管狭窄的椎间垫片。
发明背景
腰椎管狭窄(LSS,有时称为坐骨神经痛)是一种以腰椎管变窄为特征的脊柱病症。在椎管狭窄的情况下,所述椎管变窄,并挤压脊髓和神经,导致后背和腿疼痛。估计每年每10000人中有大约5个人会患上LSS。在那些为背部疼痛而求医的患者中,约12-15%被诊断为患有LSS。
已经确定了一些椎管狭窄的病由,包括老化、遗传、关节炎以及到下脊柱的血流发生变化。老化被认为是最常见的病由,这是因为人年老时,连接脊柱骨头的韧带变薄,并且在骨头上可能长出骨刺,并进入椎管。在椎骨之间的缓冲盘(cushioning disc)也常常会退化,并且骨面关节会开始折断。在某些情况下遗传也被认为是很重要的,这是因为它会使某些人的平均椎管小,常常导致在相对年轻的时候就患上LSS症。
椎骨狭窄最常见的症状是疼痛和行走困难,虽然也能感受麻木、麻刺感、腿的冷热感觉以及虚弱或疲劳。在极端情况下,椎骨狭窄会导致马尾综合征,它是一种以神经肌肉紊乱为特征的病症,会导致永久的神经损伤。
LSS的常规治疗方法包括物理治疗(包括改变身体姿态)、药物治疗以及偶尔进行手术。改变身体姿态以及物理治疗能有效地弯曲脊柱,扩大脊髓和神经所需的空间,由此减轻对受压神经的压力。药物治疗如NSAIDS和其它消炎治疗常用于减轻疼痛,但是它们通常不能有效地解决疼痛的根源。手术治疗比药物或物理治疗更加具有侵入性,但是在合适情况下手术会是减轻与LSS有关病症的最佳途径。
用于治疗LSS的最常见的手术方法是无压缩的(decompresive)椎板切除术,其中,除去一个或多个椎骨的薄层,形成用于容纳神经的更多空间。也可以除去椎间盘,并且可以合并椎骨以使不稳定的关节牢固。已经报道无压缩的椎板切除术的成功率超过65%,在多数情况下能显著缓解LSS病症。
最近已经发明了第二种手术技术,其中,将椎骨岔开,并植入椎间垫片,使关节之间保持所需的间隔。这种技术比无压缩的椎板切除术的侵入性稍低,但是却给患有LSS症的患者带来明显的好处。
和其它手术一样,当进行手术来植入椎间垫片时要考虑的一个问题是需要将器件引入的切口大小。通常优选最小侵入式技术,但是本领域已知的椎间垫片并不能很好地配合最小侵入式手术。已知垫片的植入轮廓不能通过很小的切口来引入。
因此需要一种能使用最小侵入式手术植入的椎间垫片。本发明就解决了这种需求。
发明概述
简而言之,本发明一方面提供了一种可呈压扁的第一构型,以及展开的第二构型的椎间垫片。所述垫片可以最小侵入的方式植入,这是因为垫片的压扁构型的轮廓减小。
本发明还提供了一种将椎间垫片引入相邻棘突之间的方法。所述方法较好包括:a)提供能呈压扁构型和展开构型的垫片,其中,所述压扁构型为可植入的轮廓,它比垫片呈展开构型时的相应轮廓小至少10%;b)使所述垫片呈现其压扁的构型;c)在所述垫片呈压扁构型时将所述垫片植入患者中;和d)在患者体内时所述垫片呈展开构型。结果,所述展开构型的垫片位于相邻棘突之间。
在本发明的一方面,所述垫片包括块件和四个从该块件延伸出的臂。因此,所述垫片在松弛构型时呈“H”形,在压扁构型时呈“I”形。用于植入这种垫片的方法包括:a)将所述垫片压扁成“I”形;b)将压扁的垫片置于套管中,便于植入患者中;c)从不贯穿的背部通道将所述套管的远端置于患者中,使所述套管端挤开(clear)一对相邻棘突中的各突起;d)推动压扁的垫片通过所述套管,直到两个臂离开所述套管,使它们纵向置于相邻棘突旁边;f)抽出所述套管,同时使所述垫片继续通过该套管,使所述垫片离开套管,并使剩下的两个臂纵向置于相邻棘突的其它侧。
通过以下描述,本发明这些和其它方面的目的和优点将显而易见。
附图简要说明
图1A-1C显示了本发明一个优选实施方式中的椎间垫片。
图2A-2E显示了植入患者体内的图1所示的椎间垫片。
图3A-3C显示本发明另一优选实施方式的椎间垫片。
图4A-4D显示本发明另一优选实施方式的椎间垫片。
图5显示本发明另一优选实施方式的椎间垫片,它包括给该器件提供可调节高度的刚性垫片部分。
图6显示了植入患者体内的椎间垫片。
图7A-7L显示本发明其它优选实施方式中椎间垫片的另一形状。
图8A-8M显示本发明其它优选实施方式中椎间垫片的代表性构型。
图9A=9B显示本发明一个优选实施方式中使用的垫片/稳定器。
图10A-10K显示本发明其它优选实施方式中的另一垫片/稳定器。
优选实施方式说明
为了便于理解本发明的原理,在某些优选实施方式中使用编号,并且使用具体的语言来说明相同的内容。但是无论如何应理解这并不是用于限制本发明的范围,可以预计在优选实施方式中的变化以及进一步的修改,这是本发明相关技术领域的技术人员所知的。
如上所述,本发明一方面涉及一种在相邻棘突之间提供椎间垫片的方法。所述方法可以通过以下步骤来完成:a)提供能呈压扁构型和展开构型的垫片,其中,所述压扁构型为可植入的轮廓,它比垫片呈展开构型时的相应轮廓小至少10%;b)使所述垫片呈现其压扁的构型;c)在所述垫片呈压扁构型时将所述垫片植入患者中;和d)在患者体内时使所述垫片呈展开构型。结果,所述展开构型的垫片位于相邻棘突之间。
至于所述垫片的总体特征,所述垫片设计成保持相邻椎骨的棘突之间最小的距离。因此,所述垫片通常具有块状部分,用于防止椎骨靠在一起。通常,所述块状部分使棘突之间的距离为1/4至1/2。
此外,所述垫片较好设计成贴身地密合棘突,由此避免因脊柱移动而移位。在一个实施方式中,所述垫片设计成具有一端,包括从块状部分向上延伸出的、沿上棘突两侧的“臂”,以及从块状部分向下延伸出的、沿下棘突两侧的“臂”。所述臂防止垫片相对于棘突而横向移动。在一些实施方式中,所述臂具有松弛的构型,使相对臂之间的距离稍小于该处棘突的宽度。因此,该臂将夹住棘突,为植入的垫片提供额外的稳定性。
在本发明的一方面,所述垫片包括块件和四个从该块件延伸出的臂。因此,所述垫片在松弛构型时呈“H”形,在压扁构型时呈“I”形。用于植入这种垫片的方法包括:a)将所述垫片压扁成“I”形;b)将压扁的垫片置于套管中,以便于植入患者中;c)从不贯穿的背部通道将所述套管的远端置于患者中,使所述套管端挤开一对相邻棘突中的各突起;d)推动压扁的垫片通过所述套管,直到两个臂离开所述套管,使它们纵向置于相邻棘突旁边;f)抽出所述套管,同时使所述垫片继续通过该套管,使所述垫片离开套管,并使剩下的两个臂纵向置于相邻棘突的其它侧。
在一个实施方式中,由于所用材料使得垫片很有弹性且柔韧,所述垫片可以压扁。在这种实施方式中,所述垫片的臂可以进行操作,以仅仅通过将该臂从通常垂直于“H”的十字杆件的方向弯曲成通常平行于“H”的十字杆件的方向,以从H形变成I形。因此,在一个实施方式中,通过向上和向下折叠延伸臂,使它们沿水平延伸(即,折叠的臂沿大致平行于“H”的十字杆件的方向延伸),由此将H形植入物转变成I形植入物。当操作垫片臂的作用力撤去时,所述臂回复其原始的取向,通常是垂直于“H”的十字杆件。下述图1A-1C显示了一个H形实施方式的操作情况。
在另一实施方式中,由于中枢点靠近垫片的中心,该垫片可以被压扁。这种实施方式就像一对剪刀一样,从中枢点延伸出四个臂。这时,该器件通过将一对臂在中枢轴上相互转动来从大致“X”形器件变为大致“I”形器件。图4A-4C,如下所述,显示了一个这种中枢转动的实施方式。
所述垫片能呈现出压扁的构型,使得该垫片能使用最小侵入式手术植入。最好的是,该手术使用非贯穿的背部通道通过患者背部的小切口来完成。
不论用于植入的手术方法如何,当所述垫片进入体内时,它所呈现的“植入轮廓”对应于当其通过体内开口平面时的植入物尺寸。因此,所述植入轮廓限定了需要接受植入物的开口大小。虽然明白在将其植入患者体内时不同外科医生可能使用不同的垫片取向,但是通常优选植入轮廓最小的取向。为此,术语“植入轮廓”用于确定其通过体内开口时的植入物尺寸,假设植入物操作成具有最小的可能的植入物轮廓。当植入物的不同部分通过所述开口时,通过开口的植入物部分的尺寸会变大或缩小,所述植入轮廓是植入过程中开口的最大尺寸,这对应于容纳植入物所需的最小开口大小。
在本发明一个实施方式中,所述植入轮廓比垫片呈展开构型时的相应轮廓小至少10%。在其它实施方式中,所述植入轮廓比垫片呈展开构型时的相应轮廓小至少20%。更好地是,所述植入轮廓比垫片呈展开构型时的相应轮廓小至少25%。最好的是,所述植入轮廓比垫片呈展开构型时的相应轮廓小至少50%。
用于本发明的椎间垫片可以由各种生物相容材料形成,该材料可以进行可逆的弹性形变。这种材料的例子包括弹性或橡胶聚合物、水凝胶或其它亲水聚合物、或者它们的复合物。特别合适的弹性体包括硅氧烷、聚氨酯、硅氧烷和聚氨酯的共聚物、聚烯烃如聚异丁烯和聚异戊二烯、氯丁橡胶、腈橡胶、硫化橡胶和它们的混合物。
聚氨酯的例子包括热塑性聚氨酯、脂族聚氨酯、嵌段聚氨酯、亲水聚氨酯、聚醚-氨基甲酸酯、聚碳酸酯-氨基甲酸酯和硅氧烷-聚醚-氨基甲酸酯。其它合适的亲水聚合物包括聚乙烯醇水凝胶、聚丙烯酰胺水凝胶、聚丙烯酸水凝胶、聚(N-乙烯基-2-吡咯烷酮)水凝胶、聚甲基丙烯酸羟乙酯水凝胶、和天然存在的物质如胶原质和多糖类、如透明质酸和交联的含羧基的多糖、以及它们的混合物。
在其它实施方式中,所述垫片由能进行可逆弹性形变的金属如形状记忆金属或者镍钛制得。
选择用于形成垫片的嵌段部分所用材料的性质,使所形成的植入物具有足够的承重能力。在优选的实施方式中,要求压缩磨料至少约为0.1Mpa,虽然更优选压缩强度在约1-20Mpa的范围内。最优选压缩模量至少约为5Mpa。
在一些实施方式中,所述垫片也有利地传递需要的药剂。所述药剂可以是生长因子,它可有利地修复损伤的组织或骨头,并且可以包含诱骨(osteoinductive)因子(例如,骨形态生成蛋白)、变形生长因子-ss(TGF-ss)、胰岛素类生长因子、血小板生长因子、纤维原细胞生长因子或其它类似的生长因子或者具有能修复组织或骨头的能力的其它混合物。
在本发明的其它形式中,所述垫片包括用于治疗各种脊柱病症(包括椎间盘退化病、脊椎关节炎、脊椎感染、脊椎肿瘤和骨质疏松症)的药剂。这种药剂包括抗生素、镇痛剂、消炎剂包括类固醇类、以及它们的混合物。本领域技术人员熟知其它这类药物。这些药物也可以治疗有效量使用。其量由本领域技术人员根据具体的病症来确定。
若有的话,所述药剂较好分散在垫片中,用于体内释放。所述药剂可以通过在垫片形成时将该药剂加入垫片中,将形成的垫片浸泡在包含该药剂的合适溶液中,或者通过本领域技术人员熟知的其它合适方法分散在垫片中。在本发明其它形式中,所述药剂可以和垫片以化学或其它方式关联。例如,所述药剂可以化学附着到垫片的外表面。
在一些实施方式中,所述器件包括一种或多种X-射线标记物,如钽标记物,便于植入物定位。可以使用较大的X-射线标记物和较小的X-射线标记物的组合,便于在植入时观察器件的取向。所述X-射线标记物在X-射线下更容易观察,制得器件的定位和取向更加容易观察且更准确。
现在参见附图,图1A-C显示了本发明一个实施方式的椎间垫片。垫片10包括块件15和臂11、12、13和14。当所述垫片如图1A所示呈松弛(展开)构型时,它类似于“H”形,臂11、12、13和14为“H”的分支,并且块件15为十字杆件。如附图所示,当垫片呈松弛/展开的构型时,所述臂通常垂直于块件。
为了使用垫片,操作所述臂,使其平行于块件,将垫片变成压扁(可植入)的构型,如图1B和1C所示。该操作使所述垫片呈“I”形,而不是“H”。箭头a、b、c和d显示了将“H”变成“I”的操作方向。如上所述,优选的操作是通过向上和向下折叠延伸臂,使它们沿通常平行于“H”的十字杆件的方向水平延伸,来使H形植入物转化成I植入物。当垫片变成压扁/可植入的构型时,所述植入轮廓减小。
图2A-E显示用于植入所述垫片的方法的一个实施方式。在图2A中,垫片10在呈压扁/可植入构型时加入套管20中。所述垫片呈压扁的构型,使其植入轮廓由松弛构型时的相应轮廓减小。
套管20位于两个棘突之间,当套管从后部非贯穿通道插入时套管的尖端20a在棘突上延伸。当套管定位时,将垫片从套管推出,使引导的臂22和24不被折叠,从压扁/可植入的构型变为松弛/展开的构型,如图2B所示。当臂不折叠时,它们沿两个棘突的一侧向上和向下延伸,如图2C所示。
然后当垫片退出时,抽出所述套管,如图2D所示。垫片10的块状部分25位于两个棘突之间,第二对臂21和23不折叠,沿棘突的第二侧向上和向下延伸,如图2E所示。
在另一实施方式中,所述垫片具有凹痕和/或其它表面特征,便于压扁和植入垫片,或者避免当臂折叠成压扁构型时弄裂或撕裂植入物。也可以包括便于夹住棘突的形状如脊状物。
例如,图7A-7L显示具有用于减小形变过程(呈I形)中对外壁的压缩力的表面形状。所示表面形状(仅仅是可使用的许多类型和/或形状的表面特征的例子)起到减小在植入物从“H”构型折叠成“I”构型时植入物外表面受到的压缩力。
此外,在植入物的“内”表面可以包括表面形状,用于降低当植入物变形时对那些表面的张力。图8A-8M显示了这种表面形状的一些优选实施方式。在此,所示表面特征仅仅是许多类型和/或形状的表面形状的例子,它们可以用于减小当植入物从“H”构型折叠成“I”构型时在植入物内侧表面上的“拉伸”或张力。
一种有效地减小压缩力和张力的实施方式如图3A-3C所示。在该实施方式中,垫片30包括臂31、32、33和34,以及块件部分35。块件部分35包括至少一个凹痕35a,可以包括两个凹痕,如图3A所示。所述植入物如以前一样从松弛构型操作成笔直的构型。臂31和32向下折叠,直到它们大致水平,并位于与块件35相同的方向。臂32和34向上折叠,直到它们大致水平,位于与块件35相同的方向。然后,将所述折叠的植入物至于套管中,并如上所述通过小开口推入患者体内。一旦植入以后,所述装置松弛,呈H形构型,凹痕35a使植入物包围棘突,臂31、32、33和34防止横向位移。
在另一实施方式中,所述植入物具有一个或多个臂,所述臂相对于其它非枢轴转动臂进行枢轴转动。所述臂较好沿块件中的中点枢轴转动。最好的是,所述装置包括四个臂,安排成两个枢轴转动对,两对臂各自一起枢轴转动。在最优选的实施方式中,所述枢轴臂基本上为刚性的,虽然它们在其它实施方式中可以是弹性的。
图4A显示本发明一个优选的实施方式,其中所述植入物具有枢轴臂。枢轴杆47限定了臂41、42、43和44所围绕转动的点。在所述实施方式中,臂41和42形成一对,臂43和44为另一对。可以使用弹簧48将臂偏压到其闭合的位置,如图4A和4B所示。在一些实施方式中,弹簧48至少部分缠绕枢轴杆47。
为了操作植入物40,所述植入物较好能如图4A所示采用其闭合的位置。在这种位置中,植入物具有最小的植入轮廓,使闭合的植入物通过小的切口植入患者中。在将植入物引入患者体内之后,所述植入物通过使所述臂盐图4C所示箭头的方向移动来打开。这使得植入物如图4D所示呈打开的构型。在该构型中,所述植入物的轮廓大于其闭合构型时植入物轮廓。
在一些实施方式中,当所述臂打开成展开构型时,所述植入物40的块件部分具有凹面形状。这使得块件更加牢固地配合椎间突起。
在本发明另一实施方式中,所述植入物包括位于两对相对臂之间的垫片部分。所述垫片部分使得所述器件具有可调节的高度,可以使得刚性垫片部分的大小不同。
图5显示了本发明所述具有一个垫片/稳定器部分的器件的一个实施方式。在垫片50中,臂51、52、53和54从块件部分55和垫片/稳定器部分56延伸出。
具有垫片的器件以类似于没有垫片的器件一样的方式使用。因此,臂51、52、53和54可以折叠,沿块件55和垫片部分56的轴水平设置,使得该器件具有至少比该器件呈松弛构型时的相应轮廓小10%的植入轮廓。
具有垫片/稳定器的椎间垫片的另一实施方式如图9A-9B以及图10A-10K所示。这些实施方式特别有效地减小或者防止该器件在体内变形,由此减少或防止植入后出现错位和/或位移。在附图所示实施方式中,中间柄91提供了间隔效果,便于改变其所需的厚度,而所述末端部分92和93提供稳定性,防止在体内变形为“I”形。如本领域那些技术人员所理解的,所述垫片/稳定器可以结合到体内的植入物中,仅在所述器件呈“H”形之后安装和组装所述垫片/稳定器。
图6显示了在植入患者体内之后本发明一个优选实施方式的椎间垫片。垫片60的臂61、62、63和64夹住棘突66a和66b,将所述垫片固定在位。
虽然已经结合附图和上述说明详细说明和描述了本发明,但是它们应认为是说明性的,决不是用于进行限制的。应理解,仅显示和说明了优选的实施方式,并且在本发明精神的范围内所有改变和修改均要求得到保护。
Claims (4)
1.一种椎间垫片,其包括:
第一臂组件,所述第一臂组件包括第一和第二臂以及中间部分,该中间部分设置在第一和第二臂之间并且连接着第一和第二臂;第一和第二臂基本上在相对的方向延伸并且所述中间部分基本上设置成横向于所述第一和第二臂;
第二臂组件,所述第二臂组件包括第三和第四臂以及中间部分,该中间部分设置在第三和第四臂之间并且连接着第三和第四臂;第三和第四臂基本上在相对的方向延伸并且所述中间部分基本上设置成横向于所述第三和第四臂;
通过将第二臂组件相对于第一臂组件围绕枢轴进行枢转所述脊椎植入物能够从第一插入构型移动到第二展开构型;
其中,在第一插入构型中:
第一和第三臂相对于彼此间隔开来在基本上相同的方向上延伸;
第二和第四臂相对于彼此间隔开来在基本上相同的方向上延伸;
第一臂的远端设置成相对于第四臂更靠近第三臂;
第二臂的远端设置成相对于第三臂更靠近第四臂;
第一和第二臂组件的中间部分沿所述枢轴观察时重叠在一起;
其中,在第二展开构型中:
第一和第四臂在基本上相同的方向上延伸并且形成用于接收成对相邻棘突的第一棘突的下鞍部;
第二和第三臂在基本上相同的方向上延伸并且形成用于接收所述成对相邻棘突的第二棘突的上鞍部;
第一臂的远端设置成相对于第三臂更靠近第四臂;
第二臂的远端设置成相对于第四臂更靠近第三臂;
第一和第二臂组件的中间部分沿所述枢轴观察时重叠在一起。
2.根据权利要求1所述的椎间垫片,其还包括偏压弹簧,该偏压弹簧用于在第一旋转方向上相对于第二臂组件偏压第一臂组件。
3.根据权利要求1所述的椎间垫片,其还包括沿所述枢轴设置的枢转杆。
4.根据权利要求1所述的椎间垫片,其中第一臂和第二臂在第一插入构型和第二展开构型中具有基本上相同的相对方位;并且第三臂和第四臂在第一插入构型和第二展开构型中具有基本上相同的相对方位。
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PCT/US2005/015582 WO2005115261A1 (en) | 2004-05-21 | 2005-05-04 | Interspinous spacer |
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CN1290182A (zh) * | 1998-02-06 | 2001-04-04 | 骨科技术公司 | 骨移植体及其制造方法 |
FR2799640A1 (fr) * | 1999-10-15 | 2001-04-20 | Spine Next Sa | Implant intervetebral |
FR2816197A1 (fr) * | 2000-11-07 | 2002-05-10 | Jean Taylor | Prothese inter-epineuse, outil et procede pour sa preparation |
EP1330987A1 (fr) * | 2002-01-28 | 2003-07-30 | Biomet Merck France | Implant vertebral inter-épineux |
Also Published As
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AU2005247335B2 (en) | 2009-05-07 |
CA2567403A1 (en) | 2005-12-08 |
EP1765205A1 (en) | 2007-03-28 |
US20050261768A1 (en) | 2005-11-24 |
WO2005115261A1 (en) | 2005-12-08 |
JP2010162358A (ja) | 2010-07-29 |
JP4912480B2 (ja) | 2012-04-11 |
JP2008500129A (ja) | 2008-01-10 |
US8216276B2 (en) | 2012-07-10 |
US7585316B2 (en) | 2009-09-08 |
JP4495218B2 (ja) | 2010-06-30 |
US20090292315A1 (en) | 2009-11-26 |
AU2005247335C1 (en) | 2009-11-05 |
AU2005247335A1 (en) | 2005-12-08 |
CN1997320A (zh) | 2007-07-11 |
EP1765205B1 (en) | 2012-09-12 |
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