CN1668259A - 人工椎间盘装置 - Google Patents
人工椎间盘装置 Download PDFInfo
- Publication number
- CN1668259A CN1668259A CNA038169894A CN03816989A CN1668259A CN 1668259 A CN1668259 A CN 1668259A CN A038169894 A CNA038169894 A CN A038169894A CN 03816989 A CN03816989 A CN 03816989A CN 1668259 A CN1668259 A CN 1668259A
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- CN
- China
- Prior art keywords
- intervertebral disc
- disc device
- artificial intervertebral
- central
- bearing
- 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
一种人工椎间盘装置(10),用来恢复受损的椎间盘的适当解剖椎间隙,同时保持该装置植入在其间的椎骨的生物力学运动的基本正常范围。该椎间盘装置(10)包括中央承载部分(12)和外部或环形承载部分(14),并且中央承载部分(12)包括大体上轴向延伸的定位表面(16,18),用于与面对的椎骨表面配合以抵抗移位。外部承载部分(14)用于承载或与中央承载部分(12)分担负载,并且包括朝着椎骨的周边径向延伸的表面(28,32),从而使在中央承载部分(12)周围的下沉最小。这些椎间盘装置的可选形式包括两种形式,一种具有轴向扩大的中央球形承载部分(92),环形环承载部分(82)围绕着它延伸;和另一种具有上下板构件(20,22),且在板构件之间具有中央缓冲构件(36)和环绕的弹性环形构件(14)。
Description
背景技术
已经采用了人工椎间盘技术来校正受损的脊椎椎间盘,用于缓解背部疼痛并且恢复或保持椎间隙,同时使它们对脊椎的正常生物力学运动的约束作用最小。通常采用两种人工椎间盘:人工完全椎间盘,用来代替整个盘,即纤维环、髓核以及软骨板;和人工髓核,其中只是更换了髓核,而纤维环和软骨板保持不变。本发明的椎间盘并不旨在局限于上述或其他类型。
许多现有的人工椎间盘装置包括刚性固定在相邻的上下椎骨上的上下构件。这些固定构件在它们之间夹着一支承件,它们可以沿着该支承件滑动以允许相邻椎骨之间进行相对运动,参见例如美国专利申请公开2002/0035400。但是,例如这些装置通常需要特殊的表面材料和/或表面处理,以允许骨骼向内生长以便将这些构件固定在椎骨上。而且,这些装置存在移位的问题,其中中间支承体从椎骨之间移出,因此通常需要比较复杂的形状来形成用于抵抗这种椎间盘移位的止动件。
在一种相对较早的方法中,在受损的椎间盘区域中采用不锈钢球。该钢球方案虽然能够有效地提供良好的运动范围,但是容易产生下沉的问题。由于负载相当集中在钢球上的与软骨板接合的小表面上,所以该钢球会随着时间而陷入到软骨板中。换句话说,由于这些钢球植入物的尺寸不能使得脊椎的负载在其上均匀地分布,所以钢球周围的软骨板容易下沉或下落。
还曾经试图简单地用直接注入在椎间盘中或以小囊形式提供的胶质物质来代替髓核,以便使纤维环重新膨胀并且提供承载作用。但是,这些方案在用于其椎间盘纤维环基本上没有受损的病人方面受到限制。
因此,需要一种不会明显约束脊椎运动同时仍然提供与正常、健康的椎间盘类似的承载和间隔功能的人工椎间盘。
发明内容
根据本发明的一个形式,提供了一种人工椎间盘装置,它包括一中央扩大的承载部分和一外部环形承载部分,该外部环形承载部分大体上围绕着中央承载部分延伸并且允许它们之间作相对运动。内部或中央扩大的承载部分优选具有包括上下弧形表面或表面部分的主体,它可以相对于外部承载部分以及相对于脊椎的面对表面(例如,椎骨的软骨板)移位。在这方面,弧形表面没有刚性固定在椎骨上并且是弯曲的,从而允许上下椎骨例如在脊椎左右或前后弯曲并且扭转或转动时能够相对于彼此移位。同时,扩大的中央承载部分可以接合在位于相应椎骨表面中的小凹痕中,这使中央承载部分保持在相对锁定的位置中,由此防止相对于椎骨出现横向移位,从而尽管椎骨在这些承载表面上方和下方移位该植入物也不会移位。因此,该扩大的中央承载部分使人工椎间盘装置相对于椎骨定位。
中央承载或承载部分或承载组件的主体包括弧形承载表面,为承载目的,该主体可以由硬质金属材料或合金制成。或者,可以采用硬质塑料,从而在施加压缩负载的情况下为中央承载部分提供弹性。为了减震,该承载体可以设有填充有液体或凝胶或者填充有其它弹性材料的中空芯部。例如,该承载体可以由用不可压缩流体(例如,盐水)膨胀然后密封的弹性薄膜形成。为了改变中央承载体的弹性或可压缩性,可以相应地扩大或减小芯部的尺寸,或者可以改变主体材料的弹性模量。
在一个优选形式中,外部承载部分具有一主体,它包括位于弧形表面附近的径向内表面,适合或构成用于允许所述表面之间进行相对运动。该外部承载部分通过其上下承载表面或表面部分分担在椎骨之间产生出的压缩负载,以使负载在当前的人工椎间盘装置上更好地分布,从而使在其上的局部力最小。通过这样设置外部承载部分,该装置能够很好地适用于避免在其上具有高的局部负载的现有装置中会出现的下沉问题。
外部承载部分或承载组件还可以构成为提供改善的减震性能,诸如利用比硬的外部更软的主体内部。例如,在外部承载部分的所安装的上下承载板之间可以采用弹性材料层,或者环形部分的芯部层和/或外部承载部分的内部球形承载部分可以由弹性或液体胶质材料制成。与中央承载部分类似,外部承载部分可以由用不可压缩流体(例如盐水)膨胀然后密封的弹性薄膜形成。显然,也可以采用材料组合来实现所要求的减震性能。该外部承载部分还可以包括一压缩限制件,以便在外部承载部分受到负载作用时保持在处于相互面对关系的外部承载内表面和内部承载表面之间的合适公差。这样,如将在后面更详细地描述一样,尽管外部承载部分受到了压缩负载,但是内部承载部分保持其运动自由。
在一个形式中,人工椎间盘包括作为扩大中央承载部分的中央球体,和围绕着该中央球体延伸的外部承载部分的环形主体。外部承载主体的上下承载表面或表面部分优选地不会例如通过具有大于球体半径的曲率半径而朝向上下椎骨轴向伸出直到球体表面部分。换句话说,承载表面部分具有比中央承载表面部分更平缓的曲率或者为此它们可以具有平坦的结构。这使得扩大球体位于软骨板中的凹痕中,以便使人工椎间盘牢固地定位在椎骨之间,同时环形主体也有效地承担在上下椎骨之间的压缩负载。
在另一个形式中,中央承载部分包括一对大体上为圆顶状的壳体构件,该对构件跨在与外部承载部分成一体的大体上为球形的内部承载部分上以便在其上滑动。在这一点上,内部承载部分通过圆周腹板壁与外部承载部分连接成一体。这些圆顶或壳体的尺寸相对于内部球形承载部分设定,从而在圆顶的周边和腹板壁之间存在间隙。该腹板壁使外部环形承载部分如此定位,从而使这些圆顶在中央球形承载部分上移位的干扰最小。或者,可以采用将这些圆顶搭扣配合在内部球体承载部分上的适当位置中;但是,上述松散配合结构对于使压缩负载力对圆顶壳体的约束最小化是优选的。这样,这些圆顶可以容易地在内部球体部分上滑动,同时与这些圆顶的弧形表面接合的椎骨软骨板或其它椎骨表面也可以相对于它移位,从而提供具有两个相对彼此移位的界面(interface)的双极装置。
通过具有这种双极人工椎间盘结构,由于一个承载界面当在另一个承载表面上的负载变得太大时可以移位,所以降低了在任一个界面中出现的应力和磨损。可以在圆顶壳体和内部承载部分之间提供润滑剂以降低它们之间的摩擦和磨损。安装在壳体的端缘处或附近以便承载在其上的密封环使润滑剂泄漏最小化,同时使得这些壳体能够以低摩擦的方式在内部承载部分的球形表面上滑动。
附图说明
图1A-1E是根据本发明的人工椎间盘植入装置的一种形式的各种视图,显示出扩大球形中央承载部分和外部环形承载部分;
图1F-1J是图1A-1E所示的装置上进行了稍微变化以便更好地与椎骨匹配的椎间盘装置的各个视图;
图2A-2D是植入在相邻上下椎骨之间的、图1A-1E的人工椎间盘装置的各个视图;
图3A-3D是根据本发明的可选的人工椎间盘的各个视图,显示出跨在与外部环形承载部分成一体的内部球形承载部分上的一对圆顶壳体;
图4A-4D是植入在上下椎骨之间的、图3A-3D的人工椎间盘装置的各个视图;
图5A-5E是除了围绕着外部承载部分的周边延伸的圆周沟槽之外与在图3A-3D所示的类似的人工椎间盘装置的各个视图;
图6A-6F是根据本发明的另一人工椎间盘装置的各个视图,显示出装配在扩大中央球形承载部分上的一对外部环形承载部分;
图7A-7C是中央承载部分的可选结构的各个视图,显示出相对的圆顶壳体,一个具有中央支柱凸起,而另一个具有中央盘毂(hub);
图8A-8E是包括伸入到形成在内部承载部分中的开口中的图7A-7C的圆顶壳体的人工椎间盘装置的各个视图;
图9是图8A-8E的人工椎间盘装置的可选形式的剖视图,显示出一对内部承载环,相应圆顶壳体通过其与这对内部承载环之间的衬垫腹板壁而跨在该对内部承载环上;
图10A-10D是具有轴向扩大中央承载构件和外部环形承载构件的另一个可选的人工椎间盘装置的各个视图,显示出用于中央承载构件和外部承载构件的带孔主体的沙漏形结构;
图10E-10H是图10A-10D的椎间盘装置的变型,显示出形成在外部承载构件中的不同尺寸的通孔;
图11A-11H是可选的人工椎间盘装置的各个视图,显示出上下承载构件和在它们之间的承载构件;和
图12A-12I是可选的椎间盘装置的各个视图,显示出上下板构件以及位于它们之间的环形承载构件和插塞构件。
具体实施方式
参照图1A-1E,显示出一种人工椎间盘装置10,该装置包括一扩大中央承载部分12和大致上为环形的外部承载部分14,该外部承载部分具有通孔15,所述中央承载部分12设置在通孔15中。这里,给出了内部和外部承载部分的优选形状、结构和材料选择。但是,在每一种情况中,这些选择并不意味着进行限定,这是因为也可以考虑用于实现这里所述的椎间盘植入物目的的其它选择。同样,披露了几个实施方案,它们具有可以在椎间盘植入物中实际上可互换地使用的结构特征。
在图1A-1E中所示的形式中,中央承载部分12具有相对于外部承载部分14轴向扩大的主体13,从而该主体通常包括在外部承载部分14的径向上方和下方伸出的弧形表面部分16和18,以便分别接合在相邻的上下椎骨20和22的面对表面20a和22a中的凹痕中,从而将植入物10放置在其中。在该植入物装置10中,中央承载部分12可以采取大体上为球形的球体形式,从而表面部分16和18为其外球面24的一部分。环形承载部分14具有大体上为环形(例如,圆形、椭圆形或椭圆体)的主体17,它包括围绕着开口15延伸的弧形内侧表面26,该表面26面对着具有大体与球形球面24相同的曲率半径的球形承载部分12,从而该球形承载部分12可以在小的、凹入的凹痕、凹坑或凹陷处27和29中自由地转动,所述的小的、凹入的凹痕、凹坑或凹陷处形成在球体12放置在其中的椎骨面对表面中,如上所述并且如在图2A-2D中所示。同时,椎骨表面20a和22a以及尤其是形成在其中的凹入凹痕27和29可以容易在球面24上滑动。球形承载部分12的结构和转动使得椎骨20和22例如在病人扭转其背部和/或沿着各个方向弯曲背部时基本上能够承受正常范围的生物力学运动。
当所植入的椎间盘10承受压缩负载时,外部承载部分14,具体地说是其上下表面部分28和30将基本上保持椎骨20和22之间的有效间隔。因此,在当前的人工椎间盘装置10中,外部环形承载体17与球形承载主体13分担在动态运动的椎骨20和22之间产生出的负载,以避免出现现有技术的球形承载型装置的下沉问题。因此,在该椎间盘10中,外部承载部分14通常不会允许软骨板在球形承载部分12周围下沉。
如所示一样,外部承载体17的上下表面部分28和30的曲率比中央球形承载体13的弧形表面部分16和18的曲率更平缓,从而使得该外部承载体具有环形结构。因此,在该装置10中,表面部分28和30为基本上连续弯曲的外部环形承载表面32的部分,从而它们围绕着外部承载体17的径向最外点29弯曲,以形成用于环形承载部分14的外表面32的向外伸出的凸状结构29。这样,表面部分16和18延伸至在位于承载体17的中央开口15附近的中央部分17a处的最大间距处。在最厚的部分17a处,表面部分16和18的间距小于球形承载部分12的直径,从而表面部分16和18从开口15伸出,以在相应的外部承载表面部分28和30的上方和下方延伸,用于接合在凹入的凹坑27和29中。表面部分28和30的平缓曲率使得环形承载部分14能够随着时间与包括任意所附软骨板的椎骨表面20a和22a的大体凹面更匹配。例如但不是进行限制,该球形承载部分直径可以大约为6-18mm,且外部承载部分17a的最大厚度可以大约为16mm。显然,这些尺寸是根据所要治疗的病人的解剖结构来定制的。
参照图1F-1J,显示出人工椎间盘装置10a,它对于其相应的外部承载体14′具有稍微改变的楔形或鼓起结构。更具体地说,在图1J的剖视图中可以看出,外部承载体14′具有在相应的上下表面部分28a和30a之间的一较厚部分17a和较薄部分17b,并且这些部分大体上彼此径向相对,并且在它们之间具有平滑的过渡部分。由于面对的椎骨表面20a和22a通常相对于彼此处于非平行的取向,所以椎间盘装置10a的部分17a将与在彼此间隔更远的表面20a和22a之间的区域更一致,并且部分17b更好地装配在位于椎骨表面20a和22a之间的更加封闭的紧密间隔开的区域中,从而使得该植入装置10a能够紧紧地装配或楔入在椎骨20和22之间。
在椎骨20和22在该人工椎间盘装置10上施加压缩负载的情况下,中央球形承载部分12的伸出表面部分16和18将牢牢地接合在位于用于将球形承载部分12坐在其中的面对的椎骨表面20a和22a中的凹进凹槽27和29中。在脊柱运动从而使得椎骨20和22关于球形承载部分12相对移位并且必要时它在凹槽27和29中自由地转动时,该装置10受到进一步的负载,并且外部环形承载部分14的表面部分28和30用来与该球形承载部分12一起分担在椎骨20和22之间生成的压缩载荷,并且这些表面部分还可以用作用于在椎骨20和22之间可能需要的高冲击载荷承载部分的减震器,例如在后面所述的一样。这样,该人工椎间盘装置10通过中央球形承载部分12的设置来阻止两者移位,并且通过提供在该装置10的较大径向延伸表面区域(例如,由该装置上表面16和28以及下表面18和30)上分布良好的承载来避免下沉问题。例如,从延伸穿过开口15的环形承载部分14的中央轴线19到外端29的距离可以大致为12mm。
虽然可以有其它材料选择,但是目前认为内部球形承载部分12优选由比外部承载部分14更硬的材料形成,从而更硬的球12更容易保持与在表面20a和22a中的凹痕27和29一致,并且因此保留坐在其中。在这一点上,球12可以由包括钛或金属材料(例如,不锈钢)的生物兼容材料形成,而环形承载部分14可以由弹性模量更低的材料(例如,诸如聚乙烯的塑料材料)形成,以便在压缩负载力的作用下具有一些弹性。
在外部承载部分14由塑料制成的情况下,可以将支撑环箍34嵌入在该外部承载部分中,所述支撑环箍34与球形承载部分12类似由比外部承载部分14更硬的材料制成。一般来说,球形承载部分12和环箍34的硬度都大于外部承载部分14,但是它们不能彼此相同。例如,环箍34可以由硬质金属材料形成,而中央承载部分12可以具有与人类骨骼类似的硬度。为此,塑料外部承载部分14可以为人工椎间盘装置10的模制组成部件。因此,金属支撑环箍34可以在外部环形承载部分14中现场模制。该支撑环箍34用作压缩限制件以抵抗弹性塑料环形承载部分14由于在椎骨20和22之间所产生出的压缩负载而变形,从而它能够更好地保持其结构,而不管施加在其上的应力。另外,该环箍34还抵抗由脊椎运动所产生出的剪切力,以便降低在外部承载部分14的弹性材料中的这些力。
或者,外部承载体17可以具有由与较硬的外部不同并且更软的材料制成的内部芯部,从而该环形承载部分14对于作用在人工椎间盘10上的强力冲击而言具有改善的减震性能,并且更硬的外层使承载部分14的磨损最小化。例如,磨损层可以由硬质聚乙烯材料制成,并且承载体17的内部衬垫材料可以为更软的聚合或弹性材料。在另一个可选方案中,为了减震目的,主体17可以包括中空的内部,或者包括填充有液体(例如,盐水或凝胶)或其它弹性材料(例如,水凝胶和/或聚氨基甲酸乙酯)的外部弹性薄膜。
图3A-3D和图5A-5E分别涉及可选的人工椎间盘装置36和38。这些椎间盘装置36和38具有类似的结构,每个都包括由两个相对的壳体40和42形成的中央承载部分39,所述相对壳体具有跨在中央或内部球形承载部分44上的大体上为圆顶形结构,所述球形承载部分44可以与径向扩大承载部分46的主体43包括其外部承载部分45形成为一体。在主体43中形成有相对的上下环形弧形空间43a和43b,以使承载部分44和45分开的距离大于壳体40和42的厚度,从而相应的壳体端部47和49装配在其中,由此使得圆顶壳体40和42能够在该球形承载部分44上滑动。
这些装置36和38的承载部分46的结构上的其它差异涉及外部承载部分45的平面结构。这些装置36和38的承载部分45设有一对凸起部分48和50,它们围绕着承载部分的大部分圆周沿着连续弯曲的路径延伸直到这些凸起周边在它们的汇接部分会合,该汇接部分形成在它们之间的凹入区域52。这样,具有凸起的承载部分46的平面形状更接近其间植入有装置36和38的椎骨20和22的形状。环形承载部分14可以设有类似的具有凸起的平面结构。显然,外部承载部分14和46可以形成有其它结构,例如平面椭圆形,以便与它们要植入其中的椎间隙的形状更加匹配。
另一个差异在于与承载部分14的承载表面部分28和30大体上对应的承载部分46的承载表面部分54和56的结构。与环形承载部分14的表面28和30的曲率相反,显示出这些表面54和56具有大体上平坦平行的结构,从而承载体43具有更类似盘状或板状的结构。但是,一般来说这些承载表面54和56具有一定曲率是可取的,尽管这有可能相对于示出的用于植入物10的承载表面28和30作了修改。这些表面54和56之间的间隔小于中央承载部分44的直径,且因此小于其上具有圆顶壳体40和42的中央承载组件39的直径,从而所述圆顶壳体在相应表面54和56的上方和下方伸出。这样,这些圆顶壳体40和42能够放置在位于类似承载球表面部分16和18的椎骨表面20a和22a中的凹痕27和29中。为此,壳体40和42可以由比承载体43,具体地说是其球形承载部分44更硬的材料制成。因此,与该球形承载部分12类似,圆顶壳体40和42可以由陶瓷材料或不锈钢金属、钛或其合金制成,而环形承载部分46优选由塑料或聚合材料(例如,聚乙烯)制成,以为它提供在压缩负载下的刚度和弹性。承载部分46也可以由与圆顶壳体40和42类似的材料制成以便具有更高的承载能力。
圆顶壳体40和42的尺寸相对于球形承载部分44如此设置,从而使相应壳体40和42的最大直径处的周边端缘58和60与承载部分46中的腹板壁62之间存在间隙空间57,如在图3D和5D的剖视图中所最清楚地看到的一样。因此,经过圆顶壳体的端缘58和60的直径小于球形承载部分44的直径。在使用中,圆顶壳体40和42可以滑动以占据这些空间57。
腹板壁62从球形承载部分44横向或径向并且在中央延伸至环形承载部分45,该环形承载部分围绕着其上横跨着壳体40和42的球形承载部分44延伸。圆周腹板壁62径向延伸足够的距离,以使外部承载部分45与球形承载部分44间隔开,从而形成足够大的凹槽43a和43b,以允许圆顶边缘58和60滑入与腹板壁62接合,而不会受到来自承载部分46的环形承载部分45的干扰。
在该装置38中,环形承载部分45包括一径向内表面51,它大体上轴向地或者与内部承载部分44的外球面44a相切地延伸,但是通过腹板壁62与之稍微间隔开。这样,在该装置38的主体43中的相应空间43a和43b相对于装置36中的那些部分扩大,从而避免了承载部分45的外伸部分,该外伸部分可压靠在圆顶壳体部分47和49上并且可能引起在空间43a和43b中的连接。
通过上述结构,人工椎间盘装置36和38具有双极结构,其中在椎骨20和22与圆顶壳体40和42之间的相对运动可以与圆顶壳体40和42与球形承载部分44之间的相对运动一起出现。一般来说,在相应壳体40和42的内表面40a和42a与球形承载部分44的外表面44a之间的平滑表面界面的摩擦系数比在相应壳体40和42的外表面40b和42b与椎骨表面20a和22a中的凹痕27和29之间的摩擦系数低。因此,随着这些装置36和38的运动分量会出现一些差别移位,从而通常这些圆顶40和42在圆顶壳体40和42相对于椎骨20和22移位之前将更容易沿着球形承载部分44移位。这些差别连接方式使在摩擦系数较高的表面之间的磨损保持最小,这是因为滑动优选在相应壳体40和42的平滑内部弧形表面40a和42a与球形承载部分44的外表面44a之间出现。或者,如果椎骨表面的凹入凹痕27和29与壳体外表面40b和42b之间的摩擦系数更低,则移位当然优选在椎间盘装置36和38的这个界面处出现,从而使在位于壳体内表面40a和42a与球表面44a之间的较高摩擦界面处的磨损保持最低。当然,由于脊柱在其需要进行的运动期间承受着各种动态力,所以这些双极装置36和38的两个界面往往同时移位,从而为脊柱提供必要的生物力学性能同时还使在这些椎间盘装置36和38上的过度磨损保持最小。
图4A-4D显示出植入在相邻上下椎骨20和22之间的有凸起的人工椎间盘装置36。在图4C的视图中,采用了椎间盘装置36,并且纤维环65保持不变,而在另一个视图中,在去除了纤维环65的情况下植入了椎间盘装置36。为了保持纤维环65,椎间盘装置36穿过在纤维环65中的切口插入,在植入了该装置36后修复该切口。在这种情况中,装置36使纤维环65再膨胀,从而使之保持张紧,并且解除作用在纤维环65上的压缩负载。在这里所述的其他人工椎间盘装置可以按照与装置36类似的方式应用。
该装置36的环形承载主体部分45具有外周表面66(图3C),它具有与在外部环形承载部分14的相应径向外部位置处的凸状弯曲结构类似的大体凸状结构。相反,图5C中所示的装置38的承载部分46的相应表面68具有带有凹槽的或凹状结构,以使其上下凸缘边缘70和72形成得较薄。如图5C中所示的承载部分46的上述结构为它提供了更大的柔性,这是因为凸缘70和72在压缩负载的作用下能够更好地朝着彼此弯曲,并且因此从减震方面看得到了优化。具体地说,通过使凸缘70和72围绕着承载部分46的整个圆周延伸,从而例如由于脊柱沿着特定方向弯曲而导致的由承载部分46局部受到的压缩负载将使得在那里的凸缘70和72的部分绕着凹入的圆周表面68朝着彼此弯曲,同时椎间盘46的其余部分(包括凸缘70和72的未受负载作用的部分)将保持基本上不变形。一旦去除了这个负载,则凸缘70和72的弯曲部分可以弹性弯曲回到所示的基本上未变形的结构。这样,这些凸缘70和72更好地允许承载部分46的定向变形。
可选的是,包括凸缘70和72的上下环形层可以由比承载主体43的较柔软的芯部材料更硬的材料制成,从而优化在与椎骨表面20a和22a的界面处的耐磨性,并且还改善了装置38a的减震性能。例如,磨损层可以由硬质聚乙烯制成,而该主体43的芯部可以由更柔软的减震材料(例如,弹性减震材料)制成。
接下来参照图6A-6F,显示出根据本发明的另一种人工椎间盘装置74。该椎间盘装置74与图1A-1E的装置10的相似之处在于,如前面所述一样,它包括中央球形承载部分76,该中央球形承载部分例如由陶瓷材料或不锈钢或钛金属及其合金制成或由其中含有碳纤维或其它生物相容材料的材料制成,并且包括用于放置在椎骨表面20a和22a中的凹痕27和29中的凸起弧形表面部分78和80。该装置74与装置10的不同之处在于,该装置74没有环形承载部分14,而是包括一对例如由金属材料制成的、沿着中心轴线86垂直间隔开的环形板或盘82和84,所述中心轴线延伸穿过形成在相应盘82和84中的中央开口88和90,球形承载部分76容纳在所述盘中。如所示一样,盘开口88和90的最大直径稍小于球形承载部分76的直径,从而当开口88和90周围的弧形表面83和85与外部球表面92紧密配合且盘82和84处于大体上平行的取向时,盘82和84将由在它们之间的间隙94间隔开。
在该装置74受到负载并且面对的椎骨表面20a和22a接合并推压椎间盘82和84的情况下,它们将相对于彼此和轴线86移位并且枢转,从而在其周围的某些位置处将该间隙94关闭并且在其它位置处将它打开。因此,相应的上下盘82和84的上表面82a和下表面84a为装置74的主要承载表面。如所示一样,这些表面82a和84a可以如此成形,从而使相应的盘随着从周边朝着这些盘82和84的相应开口88和90延伸而变得越厚。
在可选的形式中,可以将弹性可弯曲的减震材料95安装在这些盘82和84之间。该材料95将使未加载的盘82和84保持在所示的大体上平行的取向中,但是也允许它们在压缩负载的作用下进行相对移位。在这一点上,这样选择材料95,以使它可以在盘82和84相对于彼此移位和倾斜或枢转时发生弹性膨胀和收缩。或者,这些未加载的盘82和84可以倾斜成相对于彼此处于非平行的取向,从而为所述椎间盘装置74提供与前面所述装置10a类似的楔形结构。
因此并且如上所述,在脊柱,具体地是椎骨20和22对盘82和84施加压缩负载时,它们可以相对于彼此移位,因此在它们随着脊柱运动而移位时它们能够更好地与椎骨20和22的位置相匹配。例如,如果病人向前弯曲,则上盘82将相对于轴线86倾斜,以使盘82和84之间的间隙空间94的后部大于前部。同样,如果病人使其脊柱向后弯曲,则上盘82可以绕着轴线86枢转,以使该间隙空间94的前部大于其后部。在上述每种情况中,下盘84通常也会发生一定程度的倾斜,但是其倾斜程度与上盘82并不相同,从而它们相对于轴线86的倾斜运动通常与上下椎骨20和22及其表面20a和22a相对于脊柱轴线的运动相对应。
盘82和84可以具有与有凸起的承载部分46类似的平面结构,或者它们可以为卵形或椭圆形。如在图6D的平面图中所示一样,这些盘82和84的结构包括与环形承载部分46的相应凹入区域52相比较更大的凹入或凹入区域94。另外,盘周边96的其余部分的曲率从与凹入区域94相对的凸状弯曲部分98到位于凹入区域94的任一侧上的笔直的相对侧面100和102是变化的。
参照图7A-7C,显示出中央承载部分39的可选结构。在该变型中,设有一对相对的圆顶104和106,它们与前面所述的球形承载部分44类似跨在内部承载部分107上,但是进行了修改以容纳伸出的支柱108和盘毂110,这些将在下面进行说明。
盘毂110具有凹槽112,它可以接合抵靠着支柱108的远端弯曲端部114,以抵抗会将这些圆顶壳体104和106朝着彼此进一步推动的压缩力。更具体地说,圆顶壳体104具有端缘116,并且支柱108从壳体104中心沿着轴线118延伸,从而它伸出超过边缘116。同样,壳体106包括端缘120,盘毂110沿着中心轴线118延伸超过该端缘,从而盘毂与支柱108对准。支柱108和盘毂110各自的尺寸相互配合,以使它们限定了圆顶壳体104和106之间的间距122不能超过的极限,且端缘116和120彼此大体上平行地延伸。这样,与前面所述的中央承载组件39不一样,前述的中央承载组件依靠聚合球形承载部分44的刚性或弹性来抵抗圆顶壳体40和42的压力,而优选由更硬的材料(例如,金属)制成的圆顶壳体104和106采用了相互配合的整体支柱108和盘毂110来限制在圆顶壳体之间可以出现的最大压力。显然,在正常情况下,支柱108和盘毂110将间隔开或只是轻微接合,从而它们不会承受在椎骨20和22之间所产生出的负载。
如上所述并且参照图8A-8E,对中央或内部承载部分107进行修改,以使支柱108和盘毂110可以从中伸出。如在图8E的剖视图中可以看出,承载部分107具有轴向通孔124,其具有结构相反的上下截头锥形表面部分124a和124b,支柱108和盘毂110分别延伸进入到这些表面部分中。表面部分124a和124b从在圆顶表面处的开口124的最大尺寸处至在球形承载部分107的中央处的开口124的最小尺寸处逐渐变小。这使得圆顶104和106能够自由地绕着球形承载部分107运动,从而使得支柱108和盘毂110能够来回摇动直到圆顶端部116和120与腹板壁62接合,而不会受到分别来自表面部分124a和124b的干扰。
在图9中,显示出在图8A-8E中所示的中央承载组件的另一个变型。在人工椎间盘装置125的这个变型中,不设置与腹板壁62连接成一体的有孔的中央承载部分107,而设置有上下内部承载环126和128,它们由在它们之间延伸的腹板壁62的内部延伸部130支撑。这些环126和128均具有外部弧形承载表面126a和128a,圆顶壳体104和106跨在这些表面上。这些环126和128还可以沿着腹板壁62移动,以在脊柱活动期间例如在病人在弯曲或延伸中弯曲其脊柱时使圆顶壳体104和106中的任一个或两个都能够横向运动。这样,该装置125比前面所述的装置提供更大的运动范围,这是因为现在具有三个移位界面,包括在环126和128与腹板壁62之间的最里面的界面,从而使得圆顶壳体104和106能够沿着该界面往复运动。同时,这些壳体104和106可以在凹痕27和29中转动并且绕着例如在前面所述装置中的环形表面126a和128a转动。为了耐磨的目的,这些环126和128可以由硬质聚乙烯材料制成,而为了减震的目的,腹板壁62优选由更柔软或易弯的材料制成。为了使这些环126和128在腹板壁62上滑动,腹板壁上可以涂有更硬的材料,或者具有装在其上下表面上由金属或类似硬质材料制成的衬垫,以降低腹板壁与在其上滑动的环126和128之间的摩擦系数。
接下来参照图10A-10H,显示出可选的人工椎间盘植入装置132,其具有扩大中央承载构件134和外部承载构件136,它们在通常的脊柱运动期间分担了在椎骨20和22之间产生出的压缩负载。该中央承载构件134具有支柱主体138,该主体轴向伸长,从而上下弧形承载表面140和142通常延伸超出形成在外部承载构件136的环形主体148上的相应上下承载表面144和146,与上述的椎间盘植入物类似。
外部承载主体148具有中央通孔150,它由与支柱主体138上的外侧面154成紧密面对关系的圆柱形内表面152约束。为了使形状保持承载体148具有优选的受控弹性,可以在选定位置处形成轴向延伸贯穿所述选定位置的通孔156,如图10D所示。这些孔156提高了由例如塑料制成的承载主体148的正常可压缩性或复原系数。根据这些通孔156的位置、布置和/或密度,主体148的柔性或可压缩性可以局部地增加或减少。当然,这些孔156可以按照类似的方式应用在其它椎间盘植入物,具体地说是其外部承载部分的主体中。同样,在这些孔156中也可以设置前面所述的液体或凝胶材料(例如,用在外部承载主体17中的水凝胶),从而所述孔不会一直延伸穿过主体138,而是用作其中容纳有粘弹性材料的腔室,从而改变主体148的可压缩性。
例如并且如在图10A的平面图中所示一样,可以从中央开口150到承载主体148的周边沿着径向向外的方向增加这些孔156的出现频率,从而该主体148可以按照类似的方式更容易朝着其周边被压缩。或者,例如通过让尺寸更小的孔156a更靠近中央开口150、让尺寸更大的孔156b最靠近主体148的径向外周边并且让尺寸在这些孔156a和156b中间的孔156c大体上设置在它们之间来改变这些孔156的尺寸或直径,如图10E所示一样。显然,通过选择孔156的间距和/或尺寸,可以使该承载主体148在其周围的精确位置处具有更大或更小的弯曲弹性。这样,承载主体148能在更要求承载的位置处更坚固,并且在减震更重要的位置处具有更大的可压缩性。还期望这些孔156将为承载主体148消除应力以便增加其寿命。
如在图10D和10H的剖视图中可以看出,支柱主体138优选在其表面154中设有凹槽,例如沿着其承载表面140和142之间的主体长度的大致中间位置处形成的环形沟槽139。通过这个沟槽139,在面对的承载表面152和154之间形成有间隙155。当外部承载部分136的弹性主体148受到压缩时,该间隙155为由弹性材料制成的主体148提供可以变形进入到其中并且在其中横向膨胀的空间。
在图11A-11D中显示出可选椎间盘装置175,它具有上下椎间盘板构件176和178,并且在它们之间具有承载构件180。但是,与现有装置不同,装置175与在这里所述的其它装置类似,允许在椎骨20和22与相应的椎骨接合构件176和178之间相对运动。板构件176和178在其上形成有弧形椎骨接合表面182和184,所述弧形椎骨接合表面具有从外周边向上朝着该装置175的中央轴线186延伸的平缓曲率或斜面。当这些表面182和184接近轴线186时,它们的轴向延伸程度大于径向延伸程度,从而形成中央凸起188和190。在图11C和11D中显示出的这些凸起188和190设有用于刺入到椎骨中的顶端或尖端191和193,从而使植入在椎骨20和22之间的装置175定位,但是它们也可以如图11A和11B中所示一样呈简单地弯曲或倾斜,以实现与前面所述装置的中央弧形表面部分类似的定位功能。
因此,这些表面182和184包括径向延伸的承载表面部分182a和184a以及轴向延伸的中央承载表面部分182b和184b,所述承载表面部分182a和184a沿着相应面对的椎骨表面径向延伸,这些表面部分用来使装置175定位,同时由于板构件176和178没有固定在相应的椎骨20和22上,所以还允许椎骨20和22能够绕着板构件进行相对滑动转动,具体地说绕着装置轴线186转动360°。中央承载表面部分182b和184b通过装配(而不是固定或紧固)在位于椎骨面对表面20a和22a中的相应形状的凹槽或开口中而仅抵抗板176和178的横向滑动。
如所示一样,构件180具有球形球体结构。板176和178具有与它们的表面182和184相对的弧形带凹槽的表面192和194,并且球构件180放置在其中。球构件180可以由比更软的椎间盘板构件176和178硬的材料(例如,钢)制成。用于这些构件176-180的材料优选选择对其间的相对滑动运动的摩擦阻力较低的材料,以使得这些构件176-180例如在脊柱扭转时能够转动,并且使得例如当脊柱在伸展和延伸中弯曲时这些板构件176和178与球构件180之间能够进行相对滑动,并且这些板构件176和178相对于彼此枢转。这样,装置175是双极的,这是因为其具有两个移位界面,即在板构件176和178与椎骨20和22之间的界面和在球构件180与板176和178之间的界面。
图11E-11H为与装置175类似构成的另一个装置175′的视图,它包括上下板176和178,并且在它们之间具有一球形承载部分180。该装置175′还包括围绕着球形承载部分180延伸的环形构件196,并且这些板176和178接合抵靠着其上下表面196a和196b。该环形构件196用作减震器,并且可以由合成橡胶或其它弹性材料制成,或者可以为填充有盐水的弹性隔膜。
显然,在这里所披露的人工椎间盘装置的各种形式依靠中央承载部分和围绕该中央承载部分延伸的外部环形承载部分,来提供抵抗移位的植入物,而不依靠盘固定机构(例如,侵入性骨骼紧固件、夹具等),同时还避免了中央承载部分周围的下沉问题。为此,中央承载体或承载部分或承载组件的上下弧形表面放置在椎骨表面20a和22a中的相应形状的凹槽27和29中,从而将人工椎间盘装置定位于椎骨20和22之间。在中央承载表面部分与凹槽27和29之间的界面优选为滑动的,即不是固定的界面,从而基本上为椎骨提供它们相对于彼此的正常运动范围,并且椎间盘植入在它们之间。并且因为表面部分相对于外部承载部分的轴向间距扩大,所以如果它们形成在单独的构件(例如,圆顶壳体)上或形成在单个部件(例如,中央球或立柱承载部分)上,则位于凹入凹槽中的中央表面部分的凸状曲率提供了抵抗所述装置从椎骨之间移位或横向移出的阻力。
围绕这些轴向伸出的中央承载表面部分延伸的是外部承载表面部分,它们也从该处径向向外延伸,并且大体上具有更平缓的曲率或者具有平坦的结构。如所示一样,所述外部承载表面部分如此延伸,以使它们的径向外端从上方和下方靠近相应椎骨主体的周边。因此,上外部承载表面部分通常低于轴向伸出的上中央承载表面部分,并且它们形成一汇接部分,在该汇接部分用于接合椎骨的椎间盘装置的表面部分的方向改变或者从轴向延伸占主要地位的方向过渡到径向延伸占主要地位的方向。该汇接部分为方向过渡区域,并且并不一定表示表面部分在那里连接,例如可以看出具有前面所述的球形承载部分12和环承载部分14,它们是分开的部件,并且环承载部分14围绕着球形承载部分12环形延伸,从而允许它们之间能够相对运动。同样,下外部承载表面部分通常高于轴向伸出的下中央承载表面,并且在它们的汇接部分,该装置的椎骨接合表面部分的方向也如上所述一样相对于上椎骨接合表面部分变化。这样,这些径向延伸的外表面部分限制了椎骨或其所附的软骨板在中央承载部分周围下沉的能力。如果出现任何下沉,则下沉程度由上下外部承载表面部分的轴向间距限制。换句话说,在由人工椎间盘所占据的区域中,上下椎骨的间距不能小于在外部承载表面部分之间的间距,由此限制了下沉问题。
在根据上面原理的椎间盘装置200的另一个变型中,设置凸状弯曲的上下弧形中央承载表面部分202和204,用来将位于相邻椎骨之间的装置200定位在形成在其中的相应弧形凹入凹槽中。上下外部承载表面部分206和208围绕着相应的中央承载表面部分202和204环形延伸,并且限制了在装置200的中央承载部分210周围在椎骨之间的下沉。这些上表面部分202和206一体地形成在上板构件212上,并且下表面部分204和208一体地形成在下板构件214上。这些板构件212和214可以由硬质生物相容材料(例如,涂有热解碳的钛)制成。与前面所述的椎间盘一样,中央承载表面部分202和204的轴向间隔大于外部承载表面部分206和208的轴向间隔,并且它们的曲率半径小于表面部分206和208的更平缓曲率的曲率半径。因此,随着椎骨接合表面部分延伸离开椎间盘轴线216,出现了上下汇接部分218和220,表面部分的方向和结构在所述汇接部分处经历了急剧变化,从轴向延伸占主要地位的表面部分202或204转变为径向延伸占主要地位的表面部分206或208,从而抵抗在中央承载部分210周围的下沉。为此,板构件212和214包括相应的小轴向凸起213和215,它们相对于椎间盘轴线216设置在中央并且其上形成有相应的中央承载表面部分202和204。
由于环形外部承载部分或组件222的一部分围绕着中央承载组件210延伸,所以一环形承载部分或构件224轴向设置在上下承载板212和214之间。该构件224优选由弹性材料例如合成橡胶或弹性可压缩聚合材料(例如聚氨基甲酸乙酯和硅酮组合)或水凝胶材料制成,用于承担在正常脊柱运动期间在椎骨之间所产生出的负载。为此该构件224还可以包括填充有盐水的弹性隔膜。环形构件224的轴向厚度设定为使这些板212和214相对于彼此保持轴向间隔为解剖结构上适当的距离,以便接合椎骨并且使它们保持适当地间隔。同时,承载构件224的弹性材料允许板212和214在脊柱椎骨20和22的动态相对运动期间,例如在脊柱在弯曲或延伸运动中扭转和弯曲时,相对于彼此移位或弯曲。例如,在椎间盘装置200的一个端部处,板212和214可以朝着彼此枢转,从而压缩在它们之间的构件224同时在大体上径向相对的端部处,板212和214将相互远离地枢转或移位,从而允许由弹性材料制成的构件224在板212和214之间的区域中膨胀。
该环形承载构件224可以是一复合件,其包括在其上下表面上的更硬的低摩擦耐磨涂层,以便例如在压缩和/或扭转力施加在相应的上下承载板212和214的面对的上下表面之间时,使得所述面对的上下表面在该界面区域中的磨损最小。或者,可以将上下环形衬垫或耐磨板226和228插入到上承载板212和承载构件224之间以及下承载板214和承载构件224之间的界面中,从而使得板212和214在与之接合的过程中具有低摩擦表面。
外部承载部分222的承载构件224的环形结构形成一内部中央空间230,其中设置有缓冲件或插塞构件232作为装置200的中央承载部分210的一部分。缓冲构件232一定程度地松散装配在内部空间230中,并且该缓冲构件由具有比外部承载构件224弹性模量更高的更硬材料制成。因此,在高冲击负载作用在椎骨上时,该插塞构件232可用于使环形构件224保持不会变形太大和过载。在正常的负载情况中,在上板构件212和缓冲构件232之间有一空间。更硬的插塞构件232允许环形构件224更加柔软,从而可以使其在椎骨之间的减震作用最大。同时,该构件224的材料必须具有足够的刚度或弹性以便充分地保持形状,用于在经过几百万次循环之后保持椎骨之间的稳定性,并且不会由于受到较大负载而出现不期望有的材料蠕变或塑性变形。
在图12A和12C中可以看出,板212和214具有在内部空间230中朝着彼此延伸的相应弧形凸起234和236。插塞构件232具有上下弧形凹槽238和240,它们构成为凹状以便分别与弧形凸起234和236的凸形结构相配。空间230和在其中的插塞构件232的相对尺寸如此设定,从而当插塞构件232通过将凸起236放置在凹槽240中而位于下板214上时,在插塞构件232和上板212之间,具体地说在相应表面238和其凸起234之间将存在轴向间隙242。因此,该环形构件224的轴向厚度大于插塞构件232的轴向厚度。空间230具有比插塞构件232更大的直径,从而在环形构件224的内表面224a和插塞构件232之间存在大体横向的空间,由此允许该弹性构件224在受力时能够横向变形。当椎骨由于冲击或高冲击负载而发生过载时,正常的承载环形构件224被压缩,从而占据了轴向间隙242,使凸起234与更硬的插塞构件232接合在其凹槽238中。这样,避免了弹性构件224的进一步压缩和过载。还有,凸起234和236在其凹槽238和240中的接合抵抗了板212和214与环形构件222之间的相对横向移位。
还可以想到,环形构件224和插塞构件232可以相互形成为一体,但是对于当前椎间盘装置200而言,优选地使构件224和232为单独部件。
如在图12C中可以最清楚地看出一样,弧形凸起234和236大于相应的弧形表面部分202和204。这些凸起234和236相对于轴线216设置在中央,并且与弧形表面部分202和204相比较在轴线216的任一侧上径向延伸的距离更长,从而在板凸起234和236与插塞构件232之间的承载表面界面比在定位表面部分202和204与椎骨之间的承载表面界面更大。因此,当插塞构件232受力时,它为板212和214提供了相对较大的承载表面,并且还允许板212和214之间发生枢转,且板中央凸起234和236在相应的凹槽238和240中滑动,并且构件224的大体上径向相对的部分根据作用在装置200上的负载的正确位置而压缩和膨胀。或者,表面部分202和204的尺寸可以设定为与凸起234和236相同或者甚至更大,以便使它们在该装置和椎骨之间提供的承载表面区域最大。
在图12D和12E中,显示出作了一些改进的椎间盘装置200,它包括围绕着装置200的外周边延伸的环形外壳244。该外壳244包括上下唇部246和248,它们分别夹在外部承载组件222的上下表面206和208上以使该装置200保持为装配形式以便于植入。或者,可以采用完全封装该装置200的袋子。还有,可以在板212和214与环形构件224之间设置大体上由250表示的保持结构,用于抵抗板212和214与构件222之间的相对横向移位,和抵抗它们之间的相对转动移位,以使这些盘部件保持对准。伸出的支柱252和254可以从上板212的下面向下伸出,和支柱256和258可以从下板214的上面向上伸出。在环形承载构件224的上下表面中可以形成有相应的孔对260和262,用来将相应的支柱对252、254和256、258容纳在其中,如在图12E中看到的一样。或者,这些支柱和孔的位置可以相反。在保持结构250的另一个可选形式中,可以在环形承载构件224的上下表面中形成上下环形沟槽261(在图12D中的阴影线中显示出上沟槽261),用来容纳形成在弹性环形构件224上的相应的上下凸起脊部。由于板212和214以及构件224的平面形状或结构可以为圆形之外的其他形状,所以要求这些脊部和沟槽具有类似的结构,从而抵抗这些部件之间的相对转动滑动以及平移或横向滑动。还有,其上形成有相互配合的沟槽和脊部的部件可以与如上所述的相反。
代替支柱/凹座或沟槽/脊部结构250,如图12F中所示一样,可以在装置200的周边设置结构250。上板212包括向下延伸的周边唇部凸起263,和下板214包括向上延伸的周边唇部凸起264。弹性构件224设有周边沟槽266和268,其中唇部262和264延伸以约束构件224防止其相对于板212和214进行横向和转动移位。
图12G-12I显示出作了修改的装置200,它包括形成在环形构件224的上下表面中的上下凹入通道270,所述通道从构件224的内部轴向延伸的表面224a延伸至外部周边表面224b以在每个表面处形成开口。这样,其中容纳有插塞构件232的内部空间230通过由通道270提供的流道与装置200外部的空间连通。因此,通道270允许流体在板212和214与环形构件224之间流入流出装置。这些通道270在其体积随着椎骨运动而连续变化时也防止真空条件在空间230中形成,因此通道270用作装置200的真空破坏器。通道270可以按照径向布置方式设置,从而如在图12H中可以最清楚地看出一样,几对通道270从中央空间230沿着径向相对的方向延伸。
虽然已经对本发明的具体实施例进行了显示和描述,但是显然许多改变和修改对于本领域普通技术人员而言是显而易见的,并且所附的权利要求覆盖落入在本发明的真实精神和范围内的所有那些改变和修改。
Claims (63)
1、一种脊柱人工椎间盘装置,用于植入在相邻轴向间隔开的上下椎骨之间,该人工椎间盘装置包括:
上下中央承载表面部分,它们具有弧形的大体上轴向延伸的结构,用来朝着相应面对的椎骨表面伸出并且与其滑动接合;
上下外部承载表面部分,它们从相应的上下中央承载表面部分大体上径向向外延伸以便沿着所述椎骨表面伸出,
所述中央承载表面部分轴向间隔开的距离大于径向外部承载表面部分,并且中央承载表面部分和外部承载表面部分分担了在脊柱运动期间所产生出的压缩负载,以便使在轴向扩大的中央承载表面部分周围的椎骨下沉最小;以及
位于上下中央承载表面部分与相应的上下外部承载表面部分之间的汇接部分,在这些汇接部分处,所述承载表面部分从中央承载表面部分的大体上轴向延伸改变方向至外部承载表面部分的大体上径向延伸。
2、如权利要求1所述的人工椎间盘装置,其特征在于,所述装置包括:
一中央球形承载部分,它具有一外部球形表面,该表面包括中央弧形承载表面部分;和
一外部环形承载部分,它具有形成在其上的外部承载表面部分并且包括内侧表面,该内侧表面面对着中央承载球形表面并且被构成为允许中央球形承载部分和环形承载部分之间能够进行相对转动。
3、如权利要求2所述的人工椎间盘装置,其特征在于,所述内侧表面具有大体上与球形表面轴向和径向间隔开地延伸的平坦结构或者具有其曲率半径类似于所述球形表面的弧形结构。
4、如权利要求1所述的人工椎间盘装置,其特征在于,所述上部中央和外部承载表面部分形成在上板构件上,并且下部中央和外部承载表面部分形成在下板构件上。
5、如权利要求4所述的人工椎间盘装置,其特征在于,所述装置包括由预定的弹性材料制成的位于所述上下板构件之间的环形构件,用来在所述上下板构件之间提供减震支撑,还包括一插塞构件,所述环形构件围绕着该插塞构件延伸,并且该插塞构件的轴向厚度小于环形构件的轴向厚度,而且由比环形构件的弹性材料更硬的材料制成以限制其过载。
6、如权利要求1所述的人工椎间盘装置,其特征在于,所述装置包括:
一承载体,它具有一中央扩大的弧形承载部分和其上形成有所述外部承载表面部分的外部承载部分;和
上下圆顶壳体,构成用来在所述弧形承载部分上滑动并且在其上具有相应的上部和下部中央承载表面部分。
7、如权利要求6所述的人工椎间盘装置,其特征在于,所述扩大的弧形承载部分具有球形结构。
8、如权利要求1所述的人工椎间盘装置,其特征在于,所述中央弧形表面部分具有比所述外部承载表面部分更大的曲率。
9、如权利要求8所述的人工椎间盘装置,其特征在于,所述外部承载表面部分是弯曲的、平坦的或起伏状的。
10、如权利要求1所述的人工椎间盘装置,其特征在于,所述上下外部承载表面部分形成在一外部承载部分上,该外部承载部分具有位于所述中央承载表面部分附近的径向内表面,用来允许在它们之间进行相对运动。
11、如权利要求10所述的人工椎间盘装置,其特征在于,所述外部承载部分包括具有环形部分的主体;和
中央承载部分,其具有围绕着所述中央承载部分延伸的外部承载环形主体部分和中央承载表面部分。
12、如权利要求11所述的人工椎间盘装置,其特征在于,所述环形外部承载部分和中央承载部分为不同的构件。
13、如权利要求11所述的人工椎间盘装置,其特征在于,所述中央承载部分包括与外部承载环形主体部分一体的中央主体部分。
14、如权利要求13所述的人工椎间盘装置,其特征在于,所述中央和环形主体部分包括径向延伸的腹板壁,该腹板壁使所述主体部分间隔预定的间隔空间;以及
中央承载部分的上下壳体,它们具有位于其上的相应上下弧形中央表面部分,并且所述壳体和中央主体部分构成用来允许所述壳体在中央主体部分上滑动。
15、如权利要求1所述的人工椎间盘装置,其特征在于,所述装置包括:
一外部承载部分,它围绕着中央承载表面部分延伸并且具有在其上形成有外部承载表面部分的主体,所述外部承载部分的主体由弹性材料制成,并且所述中央承载表面部分由比所述弹性材料更硬的材料制成;以及
在所述外部承载部分的主体中的压缩限制件,它由比所述外部承载部分的材料更硬的材料制成,用来抵抗其在压缩负载作用下的变形。
16、如权利要求15所述的人工椎间盘装置,其特征在于,所述外部承载部分包括一环形主体部分,并且所述压缩限制件包括嵌入在所述环形主体部分中的环。
17、如权利要求1所述的人工椎间盘装置,其特征在于,所述外部承载表面部分都具有一周边,它大体上限定了心形和椭圆形中的一种。
18、如权利要求1所述的人工椎间盘装置,其特征在于,所述装置包括:
一外部承载部分,它围绕着所述中央承载表面部分延伸并且具有形成在其上的外部承载表面部分;以及
一减震材料,它轴向设置在所述外部承载表面部分之间。
19、如权利要求18所述的人工椎间盘装置,其特征在于,所述外部承载部分包括上下环形板,所述环形板在其上形成有相应的上下中央承载表面部分,并且所述减震材料在所述板之间延伸以使这些板分开,并且允许所述板在椎骨运动期间相对于彼此弹性移位。
20、如权利要求1所述的人工椎间盘装置,其特征在于,所述装置包括一弧形中央承载部分和上下壳体,所述壳体形成有相应的上下中央承载表面部分并且滑动支撑在所述中央承载部分上。
21、如权利要求20所述的人工椎间盘装置,其特征在于,所述中央承载部分具有一轴向开口,并且至少一个壳体包括在所述开口中延伸以限制所述壳体朝着彼此轴向移位的凸起。
22、如权利要求20所述的人工椎间盘装置,其特征在于,所述弧形中央承载部分包括一径向延伸壁以及上下弧形承载环,所述上下弧形承载环被支撑以在设置在它们之间的壁上横向滑动,并且所述壳体被支撑用于在所述承载环上滑动以允许所述壳体在椎骨运动期间能够进行横向运动。
23、如权利要求1所述的人工椎间盘装置,其特征在于,所述装置包括一外部承载部分,其上形成有所述外部承载表面部分,并且具有由具有预定可压缩性的材料制成的主体和在该主体中的多个孔,用来改变其预定的可压缩性。
24、如权利要求23所述的人工椎间盘装置,其特征在于,所述主体具有预定数量、布置和尺寸的所述孔,以提供所述主体的可压缩性的受控变化。
25、如权利要求1所述的人工椎间盘装置,其特征在于,所述中央承载表面部分形成在中央承载部分上,并且所述外部承载表面部分形成在包括围绕着中央承载部分延伸的环形主体的外部承载部分上,所述中央承载部分具有相对于所述环形主体轴向扩大的主体。
26、如权利要求25所述的人工椎间盘装置,其特征在于,所述中央承载主体包括大体上为球形的球体或轴向拉长的支柱主体。
27、如权利要求1所述的人工椎间盘装置,其特征在于,所述装置包括:
一承载主体,它具有一轴向扩大的中央承载主体部分和围绕着所述中央主体部分延伸的一外部环形主体部分,以及一腹板壁,它将所述中央和外部主体部分连接成一体;以及
上下壳体,它们构成为在所述中央承载主体上滑动并且在其上形成有相应的上下中央承载表面部分。
28、一种人工椎间盘装置,用于植入在上下椎骨之间,所述人工椎间盘装置包括:
一中央承载部分,用于插设在所述上下椎骨之间;
中央承载部分的上下弧形中央承载表面部分,所述上下弧形中央承载表面部分位于在相应面对的椎骨表面中形成的弧形凹槽中,以防止中央承载部分在椎骨之间移动;
一环形外部承载部分,它围绕着所述中央承载部分延伸,从而该外部承载部分通过所述中央承载部分保持在上下椎骨之间;以及
外部承载部分的上下外部承载表面部分,它们从中央承载部分的相应上下承载表面部分径向向外延伸,用来与之分担负载,从而使在承载表面部分上的高度局部化负载最小。
29、如权利要求28所述的人工椎间盘装置,其特征在于,所述外部环形承载部分具有内径,并且中央承载部分的尺寸设定为与所述环形承载部分的内侧之间存在间隙,以允许它们之间能够进行相对运动。
30、如权利要求28所述的人工椎间盘装置,其特征在于,所述中央承载部分具有包括中央承载表面部分的大体上为球形的外表面,且所述外部承载部分包括中央承载部分放置在其中的中央轴向通孔和弧形内侧表面,该内侧表面围绕着所述开口延伸并且面对着所述球形中央承载部分,该弧形侧面通常具有与球形外表面相同的曲率半径,从而允许位于椎骨凹槽中的中央承载部分自由转动。
31、如权利要求30所述的人工椎间盘装置,其特征在于,所述球形外表面具有预定的直径,并且所述外部承载部分的上下表面部分轴向间隔开一定距离,该距离比所述预定直径小,从而所述中央球形承载部分相对于所述环形外部承载部分轴向扩大。
32、如权利要求28所述的人工椎间盘装置,其特征在于,接合在椎骨凹槽中的中央承载部分的上下表面部分轴向间隔开一定距离,该距离比所述外部承载部分的上下表面部分之间的距离大,所述中央承载部分的上下表面部分的轴向间隔设定成使与之接合的上下椎骨之间保持在解剖学上大体上适当的间隔。
33、如权利要求28所述的人工椎间盘装置,其特征在于,所述外部承载部分的上下表面部分具有弧形结构,该结构具有比中央承载部分的弧形表面部分更平缓的曲率以便与面对的椎骨表面的形状大体上相匹配。
34、如权利要求28所述的人工椎间盘装置,其特征在于,所述环形外部承载部分具有大体上为楔形的结构,它包括在上下表面部分之间轴向扩大的部分,用来优化所述外部承载部分在椎骨之间的装配。
35、如权利要求28所述的人工椎间盘装置,其特征在于,所述外部环形承载部分围绕着椎间盘轴线延伸,并且包括上下环形板,且上承载表面部分位于所述上板上,和下承载表面部分位于所述下板上,所述板轴向间隔开并且大体上垂直于椎间盘轴线延伸。
36、如权利要求35所述的人工椎间盘装置,其特征在于,所述板在它们之间的轴向空间中具有减震材料,用于使所述板相对于彼此进行弹性移位并且将未受负载作用的板偏压至其大体上平行取向。
37、如权利要求36所述的人工椎间盘装置,其特征在于,所述中央承载部分具有包括弧形表面承载部分的大体上为球形的外表面,并且所述环形板均包括一中央开口,所述中央开口的最大直径小于球形外表面的直径,从而为轴向间隔的板提供与所述中央承载外表面的紧密配合。
38、如权利要求28所述的人工椎间盘装置,其特征在于,所述外部环形承载部分具有一中央轴向通孔,并且所述中央承载部分具有轴向伸长以延伸穿过中央开口的主体,且上下弧形表面承载部分轴向延伸超过相应的上下外部承载表面部分。
39、如权利要求38所述的人工椎间盘装置,其特征在于,所述外部环形承载部分由弹性材料制成,具有限定所述通孔的内表面,并且所述轴向伸长的主体包括外侧面,它与环形承载内表面成紧密面对关系并且具有环形沟槽,用来在面对的承载表面之间提供间隙,从而由弹性材料制成的外部环形承载部分在受力时可以变形进入到该间隙中。
40、如权利要求28所述的人工椎间盘装置,其特征在于,所述中央承载部分由比外部承载部分更硬的材料制成,以保持弧形表面部分在椎骨凹槽中的一致性。
41、如权利要求28所述的人工椎间盘装置,其特征在于,所述外部承载部分由弹性材料制成,以允许外部承载部分在压缩负载作用下发生弹性变形。
42、如权利要求28所述的人工椎间盘装置,其特征在于,所述外部承载部分具有包括其承载表面部分的外部耐磨层以及内部减震部分,所述外部耐磨层由比内部芯部减震部分更硬的材料制成。
43、一种人工椎间盘装置,其用于植入在轴向间隔开的上下椎骨之间,所述人工椎间盘装置包括:
上下板构件,用于接合相应的上下椎骨的面对表面;
位于每个所述板构件上的中央凸起,它轴向延伸并且在其上具有弧形表面,用于在与该弧形表面滑动接合的椎骨中的弧形凹槽中滑动;
位于所述板构件之间的环形承载构件,用于使这些板构件轴向间隔开,并且由弹性材料制成以允许所述板构件能够随着环形构件的弹性变形而相向和相离地移位;以及
减震构件,所述环形构件围绕着该减震构件延伸,并且该减震构件由比所述环形构件更硬的材料制成,以限制所述环形构件的变形。
44、如权利要求43所述的人工椎间盘装置,其特征在于,所述环形承载构件在轴向上比所述减震构件更厚,从而在脊柱的正常受负载作用的过程中在所述上板构件和缓冲构件之间存在有间隙。
45、如权利要求43所述的人工椎间盘装置,其特征在于,所述装置包括在所述环形构件和板构件之间的低摩擦承载表面,以使它们之间的磨损最小。
46、如权利要求43所述的人工椎间盘装置,其特征在于,所述上板和下板包括朝着彼此延伸的弧形中央凸起,且所述减震构件具有上下弧形凹槽,用于与相应的上板和下板凸起匹配和滑动接合。
47、如权利要求43所述的人工椎间盘装置,其特征在于,所述装置包括外壳或袋子,用于在植入过程中以组件的形式将所述板构件、环形承载构件和缓冲构件保持在一起。
48、如权利要求43所述的人工椎间盘装置,其特征在于,所述板构件和环形构件包括位于它们之间的保持结构,所述保持结构阻止所述板构件相对于环形构件进行横向和旋转移位。
49、如权利要求48所述的人工椎间盘装置,其特征在于,所述保持结构在所述环形构件和板构件的其中一个中包括有环形沟槽以及在所述环形构件和板构件中的另一个中包括有延伸进行所述沟槽的凸起。
50、如权利要求43所述的人工椎间盘装置,其特征在于,所述环形构件限定了一中央内部空间,所述减震构件松散地设置在该空间内,并且所述环形构件包括通向所述环形构件的内部空间和外部的开口,以在它们之间形成流道。
51、如权利要求43所述的人工椎间盘装置,其特征在于,所述环形构件和至少一个所述板构件包括在它们之间的通道,用于在所述椎间盘装置的内部和外部提供流体流动。
52、如权利要求51所述的人工椎间盘装置,其特征在于,所述环形构件具有面对着相应上下板构件的上下表面,并且所述通道包括形成在弹性环形构件的上下表面中的多个径向延伸通道。
53、如权利要求43所述的人工椎间盘装置,其特征在于,所述环形承载构件的弹性材料包括水凝胶。
54、一种人工椎间盘装置,其用于植入在上下椎骨之间,该人工椎间盘装置包括:
上下弧形承载壳体,用于滑动接合抵靠上下椎骨的相应面对表面;
中央承载部分,它具有弧形外表面并支撑着所述壳体以使壳体在其上可滑动,从而允许在椎骨运动期间在壳体与所接合的椎骨之间的相对运动和所述壳体与中央承载部分之间的相对运动之间存在差别移位;以及
环形外部承载部分,它围绕着所述中央承载部分延伸以便与所述承载壳体分担负载。
55、如权利要求54所述的人工椎间盘装置,其特征在于,所述中央承载部分具有大体上为球形的结构并且所述壳体具有圆顶结构,用于在所述球形中央承载部分上滑动。
56、如权利要求55所述的人工椎间盘装置,其特征在于,所述中央承载部分具有预定的直径,并且所述圆顶壳体的最大直径小于所述预定直径。
57、如权利要求54所述的人工椎间盘装置,其特征在于,所述装置包括腹板壁,它将所述中央和外部承载部分连接在一起并且使它们相互横向间隔开,从而使滑动的承载壳体与外部承载部分之间的干涉最小。
58、如权利要求57所述的人工椎间盘装置,其特征在于,所述腹板壁与所述中央和外部承载部分成一体。
59、如权利要求54所述的人工椎间盘装置,其特征在于,所述中央承载部分和环形外部承载部分相互横向间隔开以在它们之间形成间隙,其中所述壳体可以滑动,并且所述环形承载部分具有轴向延伸以使凹槽的尺寸最大的内侧表面。
60、如权利要求54所述的人工椎间盘装置,其特征在于,所述环形承载部分由弹性材料制成,并且具有包括上下凸缘和位于所述凸缘之间的凹入沟槽的外周表面,以优化所述凸缘在压缩负载作用下的柔性。
61、如权利要求54所述的人工椎间盘装置,其特征在于,所述外部承载部分包括由用于减震的减震材料制成的芯部和由用于耐磨的硬质材料制成的上下承载表面。
62、如权利要求54所述的人工椎间盘装置,其特征在于,所述中央承载部分包括一轴向通孔,并且所述壳体包括在所述通孔中延伸的凸起,所述凸起相互配合以限制所述中央承载部分的压缩和所述壳体朝着彼此的轴向移位。
63、如权利要求54所述的人工椎间盘装置,其特征在于,所述装置包括在所述承载部分之间横向延伸并将所述承载部分连接在一起的腹板壁,并且所述外部承载部分包括腹板壁的内部延伸部以及上下弧形承载环,所述承载环支撑着相应的上下壳体以便在其上滑动,并且所述壳体被支撑以在包括其延伸部的腹板壁上滑动。
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EP (1) | EP1513475A4 (zh) |
JP (1) | JP2005527296A (zh) |
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-
2002
- 2002-10-29 US US10/282,620 patent/US7001433B2/en not_active Expired - Fee Related
-
2003
- 2003-05-23 AU AU2003245321A patent/AU2003245321A1/en not_active Abandoned
- 2003-05-23 CN CNA038169894A patent/CN1668259A/zh active Pending
- 2003-05-23 EP EP03738960A patent/EP1513475A4/en not_active Withdrawn
- 2003-05-23 JP JP2004506700A patent/JP2005527296A/ja active Pending
- 2003-05-23 WO PCT/US2003/016394 patent/WO2003099172A1/en active Application Filing
-
2005
- 2005-07-19 US US11/184,625 patent/US8262731B2/en not_active Expired - Fee Related
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
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CN104812338A (zh) * | 2012-11-16 | 2015-07-29 | 兰克斯股份有限公司 | 斜向膨胀式融合器设备和方法 |
CN103190969A (zh) * | 2013-05-02 | 2013-07-10 | 山东威高骨科材料有限公司 | 人工椎间盘 |
CN110494102A (zh) * | 2017-04-04 | 2019-11-22 | 罗伯特·B·齐奥巴 | 用于恢复脊柱运动能力的移动笼式系统 |
CN110494102B (zh) * | 2017-04-04 | 2022-07-15 | 罗伯特·B·齐奥巴 | 用于恢复脊柱运动能力的移动笼式系统 |
CN111317597A (zh) * | 2020-02-24 | 2020-06-23 | 汕头大学 | 一种3d打印的仿生人工颈椎间关节 |
CN111317597B (zh) * | 2020-02-24 | 2022-03-18 | 汕头大学 | 一种3d打印的仿生人工颈椎间关节 |
CN117618166A (zh) * | 2024-01-25 | 2024-03-01 | 中国人民解放军总医院第一医学中心 | 椎间植入部件 |
Also Published As
Publication number | Publication date |
---|---|
US20030220691A1 (en) | 2003-11-27 |
EP1513475A1 (en) | 2005-03-16 |
US20050256581A1 (en) | 2005-11-17 |
AU2003245321A1 (en) | 2003-12-12 |
JP2005527296A (ja) | 2005-09-15 |
WO2003099172A1 (en) | 2003-12-04 |
US8262731B2 (en) | 2012-09-11 |
EP1513475A4 (en) | 2008-03-19 |
US7001433B2 (en) | 2006-02-21 |
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