CN101990419A - 包括椎间可插入的流体可压载插入物以及椎间辐条状保持固定用具的脊柱支撑植入物 - Google Patents

包括椎间可插入的流体可压载插入物以及椎间辐条状保持固定用具的脊柱支撑植入物 Download PDF

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CN101990419A
CN101990419A CN2008801245511A CN200880124551A CN101990419A CN 101990419 A CN101990419 A CN 101990419A CN 2008801245511 A CN2008801245511 A CN 2008801245511A CN 200880124551 A CN200880124551 A CN 200880124551A CN 101990419 A CN101990419 A CN 101990419A
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leg
succession
vertebra
bearing
center support
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米古尔·A·利纳雷斯
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Linares Medical Devices LLC
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Abstract

一种与接连的脊椎骨相关的植入物支撑装置，包括一个具有多个支脚的固定用具，每个支脚都从一个可旋转轴承或适合的互相连接的支撑件延伸。所述支脚中的每一个都终止于成角度的突出尖端，该突出尖端与选定椎骨的表面接合。其他特征包括限定在所述支脚以及以单独地可容许旋转的方式围绕所述轴承的所述拱形/半球形安装定位件之间的底切部分。椎间支撑衬垫也定位在接连的椎骨之间，且可与辐条状支撑固定用具结合或者被设置为与辐条状支撑固定用具分立。

Description

包括椎间可插入的流体可压载插入物以及椎间辐条状保持固定用具的脊柱支撑植入物
相关申请的互相引用
本申请要求于2007年11月19日提交的美国临时专利申请编号60/988,921以及于2008年11月18日提交的美国专利申请编号12/273,067的优先权。这两个申请的内容均通过引用全文被纳入本说明书。
技术领域
本发明教导了一种脊柱支撑植入物(spine support implants)的改进应用，这些改进的应用具体地涉及用于接连的椎骨的辐条状固定用具(web harness)支撑件的型式，并且该辐条状固定用具支撑件的型式与选择性的衬垫植入物(cushioning implants)或与该辐条状固定用具一起形成的整体限定的且可移位安装的盘状部分组合，可以起到向受损脊柱提供允许支撑的一定程度的运动的作用，而不需要椎骨被融合(fused)在一起。由于避免了现有技术中在脊柱内将选定椎骨融合的需要，所以防止了剩余(未融合)椎骨的原本将会发生的过载以及承受过早发生的损伤。
背景技术
在现有技术中充分地记载了椎间定位和支撑装置的各种实例。每个实例中的优点是诸如根据损伤或疾病将椎骨融合或固定。为了防止可能源于错位或畸形的椎骨之间不期望接触而引起的当前的不适或疼痛，特别是当影响到脊神经柱或其单独的分支(branches)时，将椎间运动融合或固定通常是必须的。
已知的椎间稳定装置的实例为诸如Abdou的US 2007/0093829以及Dixon的US 6,645,207中所述的装置。其他插入或修复结构也是已知的，这些结构被定位在接连的椎骨的相对环形(或主体)部分之间。它的一个实例描述于Zucherman的2005/0216087中所述的盘状修复结构。其他实例包括Michelson的US 5,522,899以及Larsen的US5,782,832中所述的人工脊柱融合植入物。
发明内容
本发明公开了一种用于将与脊柱相关联的接连的椎骨定位紧固的脊柱支撑植入物。该优选变型中的每一个都包括一个或多个辐条状保持固定用具，该辐条状保持固定用具中的每一个都具有从中心且半球状的安装定位件延伸的多个硬化塑料支脚(legs)。这些半球状定位件包括诸如以紧固且允许旋转的方式围绕一中心轴承(bearing)的重叠部分。
这些支脚中的每一个在向远距离延伸的端部都包括诸如突出尖端(tangs)/掣子(detents)，其紧固地安装至诸如单独椎骨中的底切(undercut)位置。通过这种方式，该辐条状固定用具大体地且定位地使接连的脊椎骨——该辐条状固定用具被附接至该接连的脊椎骨——固定不动，而同时允许较小程度的未对齐和运动，诸如在正常脊柱活动中常见的，这另一方面是被诸如常规替代程序中利用固定螺钉和板的脊柱融合术所阻止的。
一个椎间支撑衬垫(cushion)可以与辐条状保持固定用具分立地设置或整体地组合，该椎间支撑衬垫限定了本发明的可以在接连的椎骨之间被预定位的额外部件。在一个变型中，在被预定位在适当位置(诸如接连的盘状物的相对的主体或环形面对表面之间)之后，该囊状(bladder)构造的衬垫可以被选择性地借助流体注入加压，这是为了形成一给定的偏压压力。本发明的另一型式是将辐条状支撑固定用具和椎间支撑衬垫组合成为一个单独物品，其特征又在于硬化塑料支脚从中心且半球状的安装定位件延伸，所述安装定位件以紧固且容许旋转的方式围绕中心轴承并与盘状部分的一边缘位置整体地形成，这些支脚还包括被紧固地安装至诸如单独椎骨中的底切位置的突出尖端/掣子。
附图说明
当结合以下的详细说明阅读时，将参考附图，其中在这些附图中相同的参考标号表示相同的部件，以及其中：
图1是根据本发明的一个实施方案的与形成脊柱的一部分的多个椎骨相关联且用于可控制地、移位地支撑接连的椎骨的辐条状保持固定用具的一个布置的平面图；
图2A是根据本发明的辐条状支撑固定用具的另一配置的俯视图；
图2B是图2A中所示的固定用具配置的与图1类似的平面图，且示出了与该固定用具相关联的安装掣子(mounting detent)的周边接合位置；
图3是一个选定的支撑固定用具的视图，且示出了多个特征，诸如硬化塑料支脚从中心且半球状的安装定位件延伸，所述安装定位件以紧固且容许旋转的方式围绕一中心轴承，并且所述硬化塑料支脚包括紧固地安装至诸如单独椎骨中的底切位置的突出尖端/掣子；
图3A是选定的且位于最里面的轴承的局部视图；
图3B是示出了一个选定轴承和与给定接合支脚相关联的局部重叠环状物的接触部的另一局部视图；
图3C是又一局部视图，示出了由三个支脚支撑环状物和轴承面接触部分形成的多个重叠关系；
图4是一个椎间支撑衬垫的视图，该椎间支撑衬垫限定本发明的一部件并且以所示出的方式利用适合的流体介质被选择性地注入加压；
图5是类似于图1的视图，示出了椎间辐条状支撑固定用具与衬垫的组合件的另一实施例；
图6是带有根据本发明另一实施方案的支撑盘保持辐条状固定用具的组合件的支撑柱的另一配置的侧视图；
图7是一个椎骨——诸如在图6中也示出的且诸如现有技术中已知的椎骨——的俯视图；
图8是根据图7中的另一优选实施方案的盘和保持辐条状支撑固定用具的组合件的立体图；
图9是图8中的盘和固定用具的组合件的侧视图，还显示了多个特征，硬化塑料支脚从中心且半球状的安装定位件延伸，该安装定位件以紧固且容许旋转的方式围绕一中心轴承并与盘状部分的边缘位置整体形成，该支脚还包括紧固地安装至诸如单独椎骨中的底切位置的突出尖端/掣子；
图9A是在图9中同样示出的支脚以及可旋转轴承的一个配置的分解图；
图10是椎间支撑盘的一个替代安装配置的视图；以及
图10A是图10中示出的变型的另一立体图。
具体实施方式
图1示出了用于可控制地、移位地支撑形成脊柱的一部分的接连的椎骨的一个辐条状保持固定用具10的第一布置，该接连的椎骨如在2、4、6和8处所示。如前所述，如本文所公开的椎骨支撑植入物的这些变型起到了向受损脊柱提供允许支撑的运动度的作用，且不需要像在试图解决许多脊柱损伤中所常规进行的那样将椎骨融合在一起，而将椎骨融合在一起通常导致病人在脊柱灵活性方面经受很大损失。
如参考图3-3C同样所述的，该辐条状支撑固定用具被示出为一对等同配置的固定用具10，通常每个都包括硬化塑料支脚，参见12、14、16和18。这些支脚各自从中心的且半球状的安装定位件延伸，参见图3中的20和22，这些安装定位件又以紧固且容许旋转的方式围绕一个中心轴承24。
虽然并不限于任何具体的材料成分，但支脚12-18可以表现为一种带有清洁卫生(sanitary)特性或抗菌(antibiotic)特性的复合塑料，且还可以实现期望程度的屈曲(或弯曲)以便提供相关椎骨的重要的定位接合，同时仍然提供椎骨之间任何增量的(incrementally)(或较小的)期望程度的运动。通过这种方式，椎骨被定位固定至期望程度，而同时病人可以仍然具有一些较小程度的剩余运动或屈曲性，这与固定用具支脚构造的材料方面相一致。
如图3所示，成对支脚中的一个或多个(例如，参见再次在12和14处所示，以及在16和18处所示)可以从第一20和第二22半球状(或拱形)的安装定位件中的每一个延伸，应理解的是，重叠的安装定位件还能够根据其他形状和结构被构造，使得支脚12-18既可以单独地也可以彼此相对地表现出相应程度的屈曲性。通过这种方式，拱形(例如，半球状)部分20和22的任何程度的可容许的旋转被传递至单独的以及整体地延伸的成对支脚12和14以及16和18。支脚12-18中的每一个都还包括突出尖端(或尖头形(prong shaped)掣子)，参见图3中如分别在26、28、30和32处所示，这些突出尖端整体地在相应支脚的外侧端部形成且被紧固地安装至诸如在单独椎骨2、4、6和8中的每一个中形成的钻过孔的底切位置。
尽管没有示出，但同样可以预想到在将会促进最佳椎间稳定性而同时允许椎骨表现出较小增量程度的屈曲或弯曲可能性的位置处，可以采用替代的紧固件用于将辐条状固定用具支脚的延伸端安装至相应的椎骨。通过这种方式，防止了椎骨之间任何明显的不对齐，例如该种不对齐原本可能引起发生不期望的脊神经柱压迫(参见与选定的脊椎骨6’相关的图7的现有技术图示中所示)。
如在图3A中24处进一步所示，示出了一个选定的且位于最里面的轴承(同时参见图1和3)的局部视图，该轴承可以包括诸如重负载尼龙或其他适合的材料构造。如前所述，第一20和第二22半球状(或拱形)安装定位件以互相接触和边缘重叠的方式形成，这些安装定位件包围中心定位的轴承24并使得该轴承容易实现期望程度的“灵活性(give)”或旋转支撑(参见图3中关于选定支脚12的箭头25)。同时可以预想到在此示出的支脚可以被附接至诸如与轴承安装定位件相关联的底切部分以提供一种替代的安装变型。
图3B是另一局部视图(其中去除了选定的接触部分22)且示出了轴承24和重叠接触部分20，多个支脚12-18中的每一个都从该重叠接触部分20处延伸。同时应理解的是，该单独的拱形接触部分(例如，再一次在20和22处)不仅可以表现为用于绕轴承24以相对可旋转的自由度互相连接的配置，也可以表现为任何相对的形状，其目的是使得单独支脚具有期望程度的旋转灵活性或弯曲。
图3C是又一个局部视图，示出了由三个支脚支撑环状物和轴承表面接触部分形成的多个互相重叠的边缘，参见33、33’和33”，这些边缘围绕中心轴承24，如图3C中所示，单独的延伸支脚(以减小的长度示出)从单独重叠且轴承表面接触的部分延伸，应理解的是，不仅可以设置任意数量的被支撑单独轴承表面和重叠接触部分，而且可以设置任意多个的支脚，它们使单独支脚实现任意期望程度的相互旋转、弯曲或灵活性。
现在参考图2A，该图2A是辐条状支撑固定用具的另一结构的俯视图，参见34处，具体地示出了相关支脚36和38的特征，该相关支脚36和38成角度，以使端部限定的突出尖端(在40和42处)被安装至与选定椎骨8相关联的大致最周边(外部)限定的位置。图2A的视图还表现了给予单独支脚的屈曲性(或弯曲)程度以一致地围绕相应椎骨的外部周边而应用。参考图2B，再次显示了与固定用具34相关的，在最上面延伸的一对支脚36和38以及相应安装掣子40和42的周边位置，并且与图1中的安装布置形成对比。
与之前参考图3-3C显示和描述的一致，每个固定用具的结构也都包括一个中心轴承，一个或多个可允许旋转的接触定位件绕该中心轴承被支撑，例如在44处。如在图2B中进一步示出的，该固定用具34包括与掣子50和52相关联的第二(下部)对支脚46和48，该第二对支脚46和48同样地接合与接连的椎骨6相关联的最周边限定的位置。图1和2B的视图旨在表明对于辐条状支撑固定用具来说可能的可能安装变型的范围，具体而言是不同延伸支脚与任何适合的椎骨位置接合的能力，并不限于周边边缘或具体的高度位置。
现在参考图4，显示了一个椎间支撑衬垫54的图示，该衬垫54限定一个能够与辐条状支撑固定用具10组合使用的部件。如所示的，该衬垫54由一种柔性的流体保持(以及清洁卫生的)塑料构造，示出了一个开放的内部(参见在55处以剖视图所示)。提供了一个包括伸长针头57的注射器56，该伸长针头57使得包含在注射器筒内的一定容量的流体能够被注入到支撑衬垫54中。
该衬垫(或囊状物)54的构造和一致性使得其能够被预定位在接连的椎骨之间，如图5所示，随后它以示出方式被选择性地加压注入。图5另外示出了椎间辐条状支撑固定用具和衬垫54组合件的一个实施例。图5中示出的辐条状支撑固定用具不同于之前所描述的，在所示出的实施方案中，该辐条状支撑固定用具包括一个纵向延伸的支撑件，在图中显示为杆(stem)58，该杆58以在任意数量的接连定位的椎骨上重叠的方式延伸，且成对的支脚60和62、64和66、68和70以及72和74从该杆58延伸。单独成对支脚中的每一个都与该纵向(椎间)延伸的支撑件58成角度地偏置而延伸。
图5中的单独成对支脚还以对角且交替偏移偏置方式延伸，使得与每对支脚相关联的各自端部限定的突出尖端/掣子紧固至选定椎骨2-8的上部和下部的相对端部位置，由此经由纵向延伸的且中心支撑的杆58定位地支撑单独椎骨。同时可预想到，可以采用粘合剂以用于将纵向且对角偏置的支脚紧固。另外，该流体可注入的衬垫54，在被填充之后，在一个变体中被设计为固化和定形，由此实现相对于单独椎骨的中心主体部分的相对环状表面最小/增量程度的允许运动(再次参见图5)，该衬垫借助于外表面上安装的辐条状固定用具进一步被防止从椎骨之间移出，该衬垫可以沿一对相互连接的椎骨的相对的外侧中的每一个设置。
现在参考图6和8，显示了根据本发明另一实施方案的带有支撑盘和保持辐条状固定用具76组合件的支撑柱的另一配置的立体图和侧视环境平面图。具体而言，其在图8与图9和9A的组装图中的每一个中最清晰地示出，该盘和保持辐条状支撑固定用具组合件包括硬化塑料支脚(参见在78、80所示)的特征，这些支脚从中心的且半球状的安装部分(在82、84处)延伸。
如进一步所示出的，一个椎间盘插入部分86，诸如也表现出一硬化表面，以延伸方式与所选定的安装部分(在这一实例中是82)的边缘位置整体地形成。如在侧视图(图6)和转过90°的视图(图9)中的每一个所示，该盘插入部分86被定位在选定椎骨的一对相对且接连的环形主体表面之间形成的空间中，之后支脚78和80被紧固至该接连的椎骨的表面位置。
图9A中示出的变型与图8和9中示出的有一些不同，其中安装部分被修改，如在82’和84’处所示，使得第一部分82’表现为一种放大的内部拱形凹座，第二(较小尺寸的)部分84’有阻力地卡扣配合地(snap-fit)接合至该放大的内部拱形凹座中。轴承还是显示在88处且被定尺寸为使得其被支撑在第二安装部分84’的内部凹座上，并且一旦将第一较大的安装部分82’卡扣配合至轴承88和第二较小部分84’上，就在支脚78和80之间设立了预期角度的运动。
延伸的支脚78和80各自具有端部配置的掣子90和92，该掣子90和92被紧固至诸如沿椎骨侧面形成的底切位置(未示出)。相应地，借助于由半球状部分82和84(或图9A中的82’和84’)绕在其间支撑的半球形状轴承88实现的卡扣配合布置，支脚78和80之间允许改进的运动范围。还应理解的是，附加地或者替代地，对于在此描述的固定用具或内部支撑衬垫布置中的任一种，也可以设置盘支撑件和保持固定用具的组合件76。
最终，图10和10A示出了其中设置有椎间支撑盘(参见94)的又一替代安装配置。与图8的变型中的成对支撑支脚对照，单独通过延伸且向内成角度的支脚96(相对于可插入盘部分94显示为基本“L”形)提供单独安装位置，该支脚96在单独突出尖端/掣子安装定位件98处终止。支撑盘94变体的目的部分地在于说明在接连的脊椎骨之间安装中心盘支撑件和外表面接合固定用具的组合件中可以采用许多可能的不同的结构之一。
尽管在此描述了本发明，其他和附加的优选实施方案对于本领域内技术人员来说也很明显的，且不偏离所附权利要求书的范围。

Claims (20)

1.一种用于接连的脊椎骨的植入物支撑装置，包括：
一个包括一中心支撑件的固定用具，多个支脚从该中心支撑件延伸，所述支脚中的每一个都表现出特定程度的屈曲性且终止于一成角度的接头，所述接头中的每一个都和与第一和第二接连的椎骨中的至少每一个相关联的位置相接合；以及
所述固定用具在所述接连的椎骨之间提供受限的运动。
2.如权利要求1所述的装置，还包括一个被包括在所述中心支撑件中的轴承。
3.如权利要求2所述的装置，还包括围绕所述中心支撑轴承被支撑的至少第一和第二拱形延伸部分，所述支脚从所述拱形安装定位件延伸，使得所述拱形部分任意程度的可容许旋转被传递至所述支脚。
4.如权利要求3所述的装置，所述第一和第二拱形部分各自都表现为大致半球形状且将所述轴承夹在它们之间。
5.如权利要求3所述的装置，所述拱形延伸部分还表现为互相重叠的边缘。
6.如权利要求4所述的装置，还包括底切部分，该底切部分限定在所述支脚以及以单独地容许旋转的方式围绕所述轴承的所述拱形/半球形安装定位件之间。
7.如权利要求6所述的装置，所述底切部分还包括一个卡扣配合布置，所述支脚单独地从该卡扣配合布置处延伸。
8.如权利要求1所述的装置，还包括一个定位在接连的椎骨之间的椎间支撑衬垫。
9.如权利要求8所述的装置，还包括由一种柔性及流体可注入的塑料构造的所述衬垫，一旦被预定位在接连的椎骨之间，就被注入一种内部压载的(ballasting)且可固化/可定形的组合物，以用于在椎骨之间设立被支撑的且增量的运动度。
10.如权利要求1所述的装置，还包括一个纵向延伸的杆，该纵向延伸的杆包括有所述中心支撑件，成对的支脚以成角度偏置的方式从该纵向延伸的杆延伸。
11.一种用于接连的脊椎骨的植入物支撑装置，包括：
一个中心支撑盘，其具有特定的形状和尺寸；
至少一个支脚，其从所述盘的一个边缘延伸且表现出特定程度的屈曲性，所述支脚终止于与第一和第二接连的椎骨中的至少一个相关联的位置相接合的成角度的接头，以在接连的椎骨的相对的且间隔的环形表面之间定位所述中心盘，所述装置在接连的椎骨之间提供受限的、被支撑的运动。
12.如权利要求11所述的装置，还包括从第一和第二中心且有阻力地内部接合的安装定位件延伸的多个硬化塑料支脚，所述安装定位件中的选定的一个与所述椎间定位的盘的所述边缘整体地形成。
13.如权利要求12所述的装置，还包括支撑在所述第一和第二安装定位件之间的一个轴承，以便于所述安装定位件相对于所述轴承进行一定程度的旋转。
14.一种用于接连的脊椎骨的植入物支撑装置，包括：
一个中心支撑件，多个支脚从该中心支撑件延伸，所述支脚中的每一个都表现出特定程度的屈曲性且终止于一成角度的接头，所述接头中的每一个和与第一和第二接连的椎骨中的至少每一个相关联的位置相接合；
一个被包括在所述中心支撑件中的轴承，至少第一和第二拱形延伸部分围绕所述轴承被支撑，所述支脚从所述拱形安装定位件延伸，使得所述拱形部分任意程度的可容许偏转被传递至所述支脚。
15.如权利要求14所述的装置，所述第一和第二拱形部分各自都表现为大致半球形状且将所述轴承夹在它们之间。
16.如权利要求15所述的装置，还包括底切部分，该底切部分被限定在所述支脚以及以单独地容许旋转的方式围绕所述轴承的所述拱形/半球形安装定位件之间。
17.如权利要求16所述的装置，所述底切部分还包括一个卡扣配合布置，所述支脚单独地从该卡扣配合布置处延伸。
18.如权利要求14所述的装置，还包括一个定位在接连的椎骨之间的椎间支撑衬垫。
19.如权利要求18所述的装置，还包括由一种柔性及流体可注入塑料构造的所述衬垫，一旦被预定位在接连的椎骨之间，就被注入一种内部压载的且可固化/可定形的组合物，以用于在椎骨之间形成被支撑的且增量的运动度。
20.如权利要求14所述的装置，还包括一个纵向延伸的杆，其覆盖接连的椎骨且包括有多个间隔开的中心支撑件，单独的多对支脚相对于所述纵向延伸的杆以成角度偏置的方式从所述支撑件中的每一个延伸。
CN2008801245511A 2007-11-19 2008-11-19 包括椎间可插入的流体可压载插入物以及椎间辐条状保持固定用具的脊柱支撑植入物 Pending CN101990419A (zh)

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US12/273,067 US20090131984A1 (en) 2007-11-19 2008-11-18 Spine support implant including inter vertebral insertable fluid ballastable insert and inter-vertebral web retaining harnesses
US12/273,067 2008-11-18
PCT/US2008/084037 WO2009067515A1 (en) 2007-11-19 2008-11-19 Spine support implant including inter vertebral insertable fluid ballastable insert and inter-vertebral web retaining harness

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