CN101610741A - 整形外科植入物和假体 - Google Patents

整形外科植入物和假体 Download PDF

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Publication number
CN101610741A
CN101610741A CNA2007800506346A CN200780050634A CN101610741A CN 101610741 A CN101610741 A CN 101610741A CN A2007800506346 A CNA2007800506346 A CN A2007800506346A CN 200780050634 A CN200780050634 A CN 200780050634A CN 101610741 A CN101610741 A CN 101610741A
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CN
China
Prior art keywords
spinal implant
plate
plate portion
fusion device
bar
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
Application number
CNA2007800506346A
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English (en)
Inventor
J·帕里
J·帕杜
G·艾奇逊
L·T·邱
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Surgicraft Ltd
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Surgicraft Ltd
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Publication of CN101610741A publication Critical patent/CN101610741A/zh
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    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8085Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with pliable or malleable elements or having a mesh-like structure, e.g. small strips
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    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0041Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels or rivets, e.g. connecting screws
    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0091Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0013Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2250/0006Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting angular orientation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys

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Abstract

本发明提供具有用于固定到邻近的椎骨的板部分(12,16,18)和用于***椎骨间的融合器部分(14)的脊柱植入物或假体(10),其中,一个或多个板部分(12可枢转地连接到融合器部分。优选地,上部的部分(16)和下部的部分(18)全部枢转地连接以围绕共同的轴线(X)旋转。

Description

整形外科植入物和假体
技术领域
本发明涉及整形外科植入物和假体,并且特别地但不唯一地涉及用于骨结构,尤其是用于颈部的、胸部的和腰部的脊柱区的骨结构的植入物和假体。
背景技术
骨和相关的结构的身体部分,例如脊柱和/或椎骨体和/或椎间盘,可能由于外伤/损伤而受压或受损,或由于疾病而受损(例如,由于肿瘤、自身免疫疾病),或由于在老化过程中的退化导致的受损。在许多这样的情况中,能够通过用假体或植入物代替受损的部分(例如,椎骨和/或盘)修复结构。一种修复方法是移除受损的部分(例如,椎骨和/或部分椎骨和/或盘和/或部分盘)并且用植入物或假体代替受损的部分,使得植入物或假体是独立式的或紧固在邻近的未受损的部分(例如,邻近的椎骨体)之间的位置。
在放置植入物或假体的位置处的骨结构的融合与此修复方法相关。通常,植入物或假体可以包括在每个端部(例如,上面的和下面的)开口的连续的壁围绕的中心的空间。认为植入物或假体的此形式允许骨在中心的空间内增长,从植入物或假体的每个末端朝向中心增长。通常,通过机械的或生物学的装置将植入物或假体直接固定到骨结构。
许多当前的植入物和假体是空的以允许骨在空的空间内生长。当代替大的结构的区段时,一个问题为,中心的空间的长度(或高度)对截面积的比率大。此比率越大,及时地或总是提供足够的血液和营养供应以允许融合和或骨生长到空的中心内的问题越多。对此问题的一个解决方案为使得中心的空间具有尽可能大的截面。然而,这受限于壁的厚度和用于植入物或假体的材料,其决定植入物或假体的机械强度。因此,整形外科医生经常在植入物或假体内的空间中塞满可注射的或可模制的骨生长促进材料或从患者身体的其它部分取得的骨的断片,即,自体移植物或来自生物相容的来源的骨,例如同种异体移植物或合成的骨。即使这样,植入物或假体可能不会完全融合到骨结构内。
金属植入物或假体的一个问题为弹性系数远高于其被固定到的骨结构的弹性系数。这形成相对较高的硬度,导致应力被传递到邻近的骨结构,例如邻近的椎骨,并且可能通过应力遮挡和骨移植物再吸收可能导致应力性骨折。
另一个问题为当单独使用植入物或假体时,其通常不能充分地固定到脊柱,并且不能提供充分的脊柱稳定性。为了实现此必要的稳定性,植入物或假体需要第二***,诸如接附到脊柱和植入物或假体的基于板或杆的***。此附加的***不是集成的,其是附加的成本,并且可能增加操作时间和患者的风险。
当融合器与用于锁定邻近的椎骨并且匹配患者的解剖学形状的覆盖该融合器的板结合时,安装结合的组件并且确保最优的椎骨运动是困难的。事实上,特别是当接近困难或椎骨的外形阻止容易地***时,融合器自身的安装是成问题的。
另一个问题为具有板的融合器通常在结构上是刚性的,并且设计为不允许在板和融合器或毗连的椎骨体和融合器之间的相对运动,尤其是在脊柱弯曲和伸展时。
另一个问题为外科医生在执行此修复的方法方面具有不同的观点。观点的范围从刚性固定到半刚性固定。当前,外科医生需要选择不同产品和不同组的器械来提供此选择,然而,本发明用一个植入物和一组器械允许此选择。
使用例如螺钉的固定件将植入物或假体接附到邻近的椎骨体。通常这样的固定件或固定***的问题为,在***椎骨体之后,固定件能够自身变松和/或退出,即,从椎骨体撤回。植入物或假体退出或变松的结果包括稳定性丧失、患者的可能的风险和分开的昂贵的并且经常是疼痛的操作。
另一个问题为植入物或假体通常由在结构上可接受的材料制造,但是无限期地保留在身体内。这样的设计为用于融合的金属植入物或假体的杨氏模量大于自然的骨的杨氏模量,这可以导致在邻近的水平面内的机械应力遮挡,造成邻近的椎骨体的高应力、变形和/或骨折。
发明内容
本发明提供包括用于固定到椎骨体的上部的和下部的板部分的脊柱植入物,其中,所述板部分中的一个或多个是围绕轴线枢转的,以允许椎骨之间的可曲性。
优选地,结构包括用于抵抗所述一个或多个上部的或下部的部分的枢转运动的抵抗装置,并且其中,所述板部分中的一个或多个包括所述抵抗装置与其接合的接合表面。
有利地,所述植入物包括安装部分,并且其中,所述抵抗装置包括具有用于与所述一个或多个板部分摩擦接合的接合部分和用于与所述安装部分接合的螺栓螺纹的螺栓。所述抵抗装置可以包括所述螺栓的螺栓头部部分,并且所述一个或多个板包括在其中具有形成接合表面并且在操作中与所述螺栓头部接合的边缘的通道。所述板部分中的一个或多个可以包括半圆形的轴环部分,所述轴线包括杆部分,并且所述半圆形的轴环部分围绕所述杆部分接合以相对于所述杆部分枢转运动。优选地,所述上部的和下部的板部分每个包括半圆形的轴环部分,并且每个与所述杆部分接合以相对于所述杆部分枢转运动。结构优选地包括用于接收所述螺栓的螺栓螺纹的安装轴套,并且所述轴套包括杆部分,所述板部分中的一个或多个安装到所述杆部分上以相对于所述杆部分枢转运动。
有利地,一个或多个板部分上的一个或多个接合表面在所述一个或多个板的内部表面上。
在特别有利的结构中,所述上部的或下部的板中的一个或多个包括用于与所述杆接合的“棘爪配合”配件。
优选地,所述上部的和下部的板包括在其面对的边缘上的切口部分,所述螺栓头部包括延伸通过所述切口部分的轴线并且包括能够通过所述切口部分接近的接合特征部,并且所述螺栓头部具有大于所述切口的尺寸的直径。
便利地,所述上部的板和所述下部的板每个包括一对轴环部分,并且其中,一对比另一对隔开更远,使得当与所述杆接合时,允许一对安置在另一对之间。
在所装配的状态,植入物包括用于***椎骨之间的融合器部分。
在特别有利的结构中,所述上部的或下部的板部分围绕共同的轴线X枢转。
融合器可以包括用于代替椎骨的代替的融合器,并且所述融合器可以包括上部的和下部的杆部分。
有利地,所述融合器部分包括具有侧臂的端部开口的融合器,并且其中,所述侧臂每个包括用于将所述融合器联接到所述板的联接件。
优选地,植入物包括杆部分,所述板围绕所述杆部分枢转,并且所述联接件包括用于与杆部分接合的一个或多个切口,并且其中,所述联接件包括用于与所述杆接合的一个或多个“棘爪配合”联接件。
在一些结构中,所述轴套部分可以在所述板部分的一个或其它板部分上。
优选地,结构包括用于将一个或其它板锁定在给定的角度位置的锁定装置,并且所述锁定装置包括在一个板部分上的用于与在所述其它板部分上的对应的表面摩擦接合的突出体。锁定装置可以包括在所述板部分的一个或其它板部分上的用于扩张和与所述其它板部分摩擦接合的可扩张的部分,并且所述可扩张的部分可以包括具有两个或更多片断的分开部分,和用于偏置所述片断分开并且与所述其它板部分接合的偏置装置。
优选地,所述上部的或下部的板部分围绕共同的轴线X枢转。
在一个结构中,融合器包括一对隔开的独立式的侧部分。
侧部分可以在其下部的边缘处通过桥接部分链接。
在一个结构中,植入物包括具有移位的旋转轴线的一对轴线隔开的上部的和下部的板部分。
便利地,植入物包括在所述上部的和下部的板部分之间的中间的板部分,并且安装为围绕所述下部的轴线枢转旋转,并且还可以包括板运动限制器。
上面提及的限制器可以包括在所述上部的板上的内部的部分和在所述下部的板上的内部的部分,其中的每个围绕共同的轴线枢转,并且能够在板运动时在接合的和脱离的位置之间运动。
虽然接下来的讨论集中在脊柱植入物或假体,应该理解,许多原理可以同等地应用于人或动物体内的其它骨结构。
附图说明
现在将参考附图通过示例更加具体地描述本发明,其中:
图1为根据本发明的第一方面的所装配的设备的总图;
图2为图1的设备的分解图;
图3为图1的设备的部分地装配的视图;
图4为上面的图中的设备的总图,并且示出了处于第一、被弄直的姿态的设备;
图5为图1到4的设备的截面视图,并且示出了其相对于融合器形成角度的板;
图6和7示出了对于本发明的设备可能的运动的自由度;
图8和9为设备的正视图,并且更加详细地示出了接近其一个部分;
图10为本发明的第二方面的总图;
图11为图10所示的设备的分解图;
图12为图10和11所示的设备的下部的部分的放大的视图;
图13为上部的部分的视图;
图14为下部的部分的再一个视图;
图15为本发明的再一个实施例的总图;
图16为本发明的修改的结构的正视图;
图17为图16的设备的分解图;
图18为图16和17的结构的替代物的分解图;
图19到图22示出了对本发明的再一个修改;
图23和24更加详细地示出了上文中提到的板停止器;并且
图25到图27示出了使用中的锁定机构。
具体实施方式
参考图1,脊柱植入物或假体10包括用于固定到椎骨的板部分12和用于***其间的融合器(cage)14。板包括上部的和下部的部分16、18,上部的和下部的部分16、18具有表面20、22和一个或多个孔24、26、28,表面20、22成形为对应其要被固定到的任何骨材料的外形,锚固紧固件(没有示出)可以***通过一个或多个孔24、26、28以便将设备固定到相应的上面的和下面的椎骨体(没有示出)。紧固件可以为螺钉、销、钉、栓或任何其它适合的紧固设备。上部的和/或下部的板部分16、18通过总地以30示出并且在此后详细地描述的卡扣配合联接件枢转地联接到融合器。联接件利用销结构32,融合器部分16、18与销结构32接合,并且融合器部分16、18可以围绕销结构32旋转或枢转(围绕轴线X)以便容许椎骨间的运动。
图2以分解的方式示出了图1的结构,从其中能够理解,销结构32侧向地延伸通过设备并且包括具有用于接收抵抗螺栓38的有螺纹的孔36的安装部分34,其功能将在下面描述。从图2中也清楚的是,在上部的和下部的融合器部分16、18的每一个上的提供“棘爪配合(click-fit)”到销结构32上的半圆形的轴环部分42、44、46和48。接合方式对于本领域的技术人员是公知的,但是为了清晰,每个轴环的弧稍微延伸超过180度,以便导致稍微干涉杆的***,但是阻力不足以阻止杆的***。如所示,下部的部分上的轴环放置在上部的部分的轴环内,然而,相反的也是可能的。图2中清晰地示出了在融合器部分14上并且通过附图标记50、52标识的一对相似的“卡扣配合”联接件。这些联接件除了将融合器联接到杆以便允许设备的全部元件围绕共同的轴线X枢转外,其以上述方式作用。如所示,融合器包括具有开口的前面的部分54的开口的融合器,并且联接件50、52提供在其端部56、58处,其它结构也是可能的。
现在简要地参考图4,应该理解,板部分可以提供有在面对的边缘64、66上的切口60、62,外科医生可以通过切口60、62接近***轴套部分的任何螺栓38的头部部分68,如将在此后更加详细地描述的。
图5-7为设备10的截面视图,并且示出了板相对于彼此和融合器14的不同的位置。从图5中能够理解,螺栓头部68可以与板的内侧的表面70、72的部分接合。更详细地,板的一个或每个可以提供有接合表面74、76,当从轴套部分34退出时,螺栓头部接合靠在接合表面74、76上。操作中,螺栓可以从轴套34退出,使得头部与接合部分的一个或其它接合部分接合,并且干涉的程度将支配接合将提供给板运动的抵抗的程度。实际上,结构形成对枢转运动的抑制,其从对运动的稍微抵抗到完全锁定在给定的角度位置变化。在优选的结构中,板的一个或多个提供有切割入其表面内并且垂直于轴线X延伸的槽,其成形并且定位为在所述板的任何角度位置与头部68接合。槽自身包括边缘80、80a、82、82a(在图4中最佳地看到),边缘80、80a、82、82a限定切口83、83a并且可以提供与螺栓头部的主要的接触表面。图5示出了处于大致垂直的关系的板和融合器,并且在板自身之间具有稍微的曲率或角度,诸如当恢复脊柱的自然曲率时需要的。图6和7示出了两个附加的角度关系,其中,由于融合器自身可以围绕轴线X枢转,已经被锁定到位的板仍然能够相对于融合器一起枢转,全部两个板元件作为一个整体与轴套部分34一起运动。板的总的运动被停止器限制,参考下面的图25到27最佳地看到停止器。
图8和9示出了处于相应的关闭的和打开的位置的板部分,并且从图中可以理解,切口83、83a提供接近六角形头部的配件84,其可以用于如希望的和当希望时调节螺栓38的位置。
融合器部分14可以由射线可透过的材料形成,诸如聚醚醚酮(PEEK),这意味着当通过x射线成像时,融合器将不会遮掩对融合器内部的骨生长的程度的检查。另外,融合器部分14可以由生物可再吸收的材料形成。生物可再吸收的材料优选地为骨传导性的或骨诱导性的(或二者全部)。板部分16、18可以由诸如钛的金属或超弹性或超塑性的材料形成,或者可以为复合材料,例如长纤维复合材料。
使用中,在移除受损的盘之后,从事者(例如整形外科医生)将融合器部分14***邻近的上面的和下面的椎骨体之间的盘空间。在***之前或之后,通过将U形的“棘爪配合”联接件推到销32上,将上部的和下部的板16、18联接到融合器14。从事者能够随后通过枢转运动来调节板16、18的角度以找到最佳的解剖学位置,以将植入物固定到椎骨体的自然的解剖体。随后调节螺栓38以便允许头部部分与板的内部表面接合,并且由此抑制枢转运动。
一些从事者喜欢在植入之后允许植入物和邻近的椎骨体之间的一定程度的运动。在那种情况下,螺栓将不与板的背部接合。其他人喜欢不允许椎骨之间的相对运动的更加刚性的植入物。本发明中的植入物允许任一偏爱。
图10到13示出了本发明的第二实施例,脊柱植入物130包括融合器部分132,其尺寸和形状对应两个椎骨体之间的空间(即,移除盘之后的盘空间)。融合器132包括成形为抓住邻近的椎骨体(没有示出)的骨表面的上部的和下部的表面133a、133b。在所示的实施例中,这些是有锯齿的表面以抵抗排出。替代地,这些表面可以具有棱锥或其它适合的形状以抵抗排出。另外,植入物包括上部的板134和下部的板136。上部的和下部的板134、136每个包含一个或多个孔137a、137b和137c,锚固紧固件(没有示出)能够通过一个或多个孔137a、137b和137c***以便将植入物固定到相应的上面的和下面的椎骨体(没有示出)。紧固件可以为螺钉、销、钉、栓或任何其它适合的紧固设备。
如上面所述,上部的和下部的板134、136通过卡扣或推配合接合联接到融合器132。如能够在图11中看到的,上部的板134提供有一对隔开的钳口140a、140b,其接合融合器132上的向外延伸的销142a、142b。相似地,下部的板136具有一对近距离隔开的钳口144a、144b,其接合融合器132上的向内延伸的销143a、143b。在图10所示的所装配的情形,板134、136在它们各自的销142、143上自由地枢转到一定程度。在此实施例中,两组销142、143是同轴的,以便为全部两个板提供单一的共同的枢转轴线。每个板134、136离开图10所示的位置在向前的方向自由地枢转。
上部的板134具有相对地面向内的表面138a、138b,在所装配的情形中,表面138a、138b邻近下部的板136的近距离隔开的钳口144a和144b上的对应的面向外的表面139a、139b。近距离隔开的钳口144a、144b通过狭窄的间隙146分开。被狭窄的间隙146分割的有螺纹的孔149从植入物的前面的侧延伸进入下部的板136。
在一个实施例中,融合器部分132由射线可透过的材料形成,诸如聚醚醚酮(PEEK),这意味着当通过x射线成像时,融合器将不会遮掩对融合器内部的骨生长的程度的检查。
融合器部分132可以由由生物可再吸收的材料形成。生物可再吸收的材料优选地为骨传导性的或骨诱导性的(或二者全部)。板部分134、136可以由诸如钛的金属或具有超弹性或超塑性的材料形成,或者可以为复合材料,例如长纤维复合材料。
使用中,在移除受损的盘之后,从事者(例如整形外科医生)将融合器部分132***邻近的上面的和下面的椎骨体之间的盘空间。在***之前或之后,通过将钳口140a、140b;142a、142b推到各自的销142;143上,将上部的和下部的板134、136联接到融合器132。从事者能够随后通过枢转运动来调节板134、136的角度以找到最佳的解剖学位置,以将植入物固定到椎骨体的自然的解剖体。随后使得螺栓147前进进入孔149,螺栓147可以为锥形的螺栓,或者具有比孔149内的螺纹略大的螺纹直径的螺栓。当上紧螺栓时,驱使近距离隔开的钳口144a、144b分开,使得驱使面向外的表面139与面向内的表面138接触,并且由此抑制枢转运动。接触面138、139可以具有粗糙的表面光洁度(稍微粗糙或较严重的粗糙)。如下面结合图13讨论的,接触面可以具有加工在其内的凹槽或键槽,一旦上紧锁定螺钉,这些凹槽或键槽彼此接合以限制运动。随后通过定位为通过孔137a、137b的紧固件(例如,螺钉)将植入物固定到椎骨体。紧固件优选地结合锁定设备,其防止螺钉退出植入物(例如,如图12所示和在下面所描述的)。
一些从事者喜欢在植入之后允许植入物和邻近的椎骨体之间的一定程度的运动。在那种情况下,***孔149的螺栓将不完全上紧。其它人喜欢牢固地锁定到邻近的椎骨体的更加刚性的植入物。植入物130允许任一偏爱。
图12更加详细地示出了与固定螺栓147一起的下部的板部分136。作为有螺纹的部分147a,固定螺栓具有向前延伸的栓形的部分147b。钳口144a、144b中的每个具有在孔149的有螺纹的部分的前面的位置处的向下延伸的孔148a、148b。在将固定螺栓147***并且上紧到要求的程度之后,能够将销***向下延伸的孔148a、148b以将固定螺栓锁定到位。销接合在栓形的部分147b的头部后面以防止固定螺栓147退出孔149。
图13示出了在其面向内的接触表面138中的一个上具有***138c的替代的板。图14的板在其面向外的接触表面139中的一个上具有一系列键槽239。当装配时,键槽239和***138a彼此接触,效果为在板之间提供比具有平滑的接触表面138、139所发生的摩擦更大的摩擦。从而,当上紧孔149内的螺栓时,更强地抑制枢转运动。
上面结合图10到14描述的植入物提供***一个平面并且自动定心的整体的设备,其可符合周围的解剖体,匹配解剖学几何形状,并且匹配自然的前面的解剖学负载限制。
图15描绘了在构思上与上述植入物相似的另一个脊柱植入物250。植入物250构造为用于代替部分或一个或多个完整的椎骨体和盘,并且包括联接到上部的板254和下部的板256的伸长的融合器部分252。在此情况下,板254、256联接到融合器以允许围绕靠近融合器252的每个端部的分开的枢转轴线枢转运动。此枢转动作防止外科医生需要在手术中形成板以符合椎骨体的解剖体。
在图10到14的实施例中,上部的板134、254的顶部成形为对应下部的板136、256的底部,以允许一系列植入物在彼此不干涉的情况下沿脊柱密集地堆叠。应该理解,代替如图所示的在植入物内具有一个上面的孔和两个下面的孔,植入物可以具有两个上面的和一个下面的孔,或者可以适合于具有两个上面的孔和两个下面的孔。另外,可以采用在每个上部的和下部的板内仅具有单一的孔的结构。
图16示出了本发明的再一个视图,而图17示出了融合器14的替代的形式,其中,融合器包括通过较小的横向构件14c链接的两个不同的侧部分14a、14b。这样的结构在融合器的***期间和在可能是必要的任何随后的修正期间将允许相对容易地安装大量的骨生长材料并且允许更好地接近。
图18示出了再一个结构,其中,融合器实际上分为两个不同的部分14d和14e,其每个提供有如上面所述的“棘爪配合”联接件。因为每侧能够与另一侧独立地定位,同时当经由“棘爪配合”配件将板联接到融合器时使全部侧稳定并且保持刚性,这样的结构提供甚至更好的接近并且容易安装。
图19到22提供椎骨代替结构,包括确定尺寸为适用于代替椎骨的高的融合器,并且具有如上面所述的上部的和下部的板16和18,并且上部的和下部的板16和18每个提供有轴套部分、螺栓38和在与其相关的板部分上的接合表面74、76。在销32上的安装与如上所述相同在于,其利用融合器板到与融合器相关的销的“棘爪配合”的联接,并且通过螺栓38和板它们自身的互相作用控制有角度的板的位置或运动的自由度的控制,如上所述。然而,应该注意,这些图的结构提供一对销,该对销标识为上部的销32a和下部的销32b,并且上部的和下部的板安装在其自己的销上。下部的板部分18可以包括两个板18a、18b,上部的板18b有效地形成中间的板160,并且这些板中的每个可以如上参考图1到9所述的安装在下部的销32b上。当提供中间的板时,其还可以在上部的边缘160a处成形以便适应或反映上部的板16的下部的边缘16b的外形,并且允许接近螺栓38。
除了板将被装配到轴套部分并且随后棘爪配合到融合器,并且这大概必须在将植入物***患者体内之前进行外,上面刚刚描述的结构的安装和锁定与参考图1到18的实施例所描述的相似。
现在参考图23和24,其示出了防止过度的板运动的停止器结构。从这些图中能够理解,上部的板部分16上的内部的表面部分200邻近下部的板部分18上的外部的表面部分202定位,并且由于每个板围绕销32枢转的事实,随着并且当上部的板在箭头L的方向过度地运动时,表面将彼此接触。此结构将防止板16、18相对于彼此过度地弯曲或旋转。这防止通过切口80、82形成的前面的开口打开得宽到足以允许螺栓38的头部通过。这用作抗退出措施以防止螺栓从组件脱离并且进入患者的身体。
一旦植入,板固定地紧固到椎骨体并且中心的螺栓与板的后面的方位接合,本发明提供如下面参考图25到27所述的有利的功能。
在中间的位置,即,患者的头部处于竖立的朝向,本发明提供对脊柱的支撑。另外,因为中心的螺栓不妨碍板向内旋转,通过设计所允许的小量运动允许将压缩负载直接施加到融合器和包含在其中的任何骨移植物或骨替代物材料。根据沃尔夫法则,此压缩负载促进造骨细胞活性并且因此促进新骨形成。参见图25。
在弯曲时,即,当患者使他们的下巴朝向他们的胸部运动时,椎骨的自然的运动是围绕朝向椎骨间的关节的前面的方位定位的旋转中心枢转,减小脊柱前凸角度并且允许颈部向前弯曲。由于骨移植物或骨替代物材料遭受拉伸负载,这可能是对于处于融合的早期阶段的椎骨间的关节伤害最大的运动。通常,骨在压缩中坚固,但是在拉伸中相当脆弱,并且在将移植物材料加入稳定的关节融合术的过程中尤其易受伤害。因为椎骨体可用的仅有的旋转轴线为围绕枢转销的轴线,所以本发明保护移植物部位免遭可能的伤害。然而,为了允许此类型的运动,板必须向外旋转,并且在此情况中,由中心的螺栓的头部妨碍运动,其防止板之间的间隙闭合。参见图26。
在延伸时,即,当患者向后倾斜他们的头部时,椎骨的自然的运动应该是围绕朝向椎骨间的关节的后面的方位定位的旋转中心枢转,增加脊柱前凸的角度并且允许颈部向后弯曲。在此情况中,本发明保护免遭因为椎骨可能倾向于围绕椎骨间的融合器的后面的边缘枢转而产生的运动。此运动将要求融合的关节的前面的元件运动分开(即,上面的板在向上的方向离开下面的板运动)。由于全部两个板围绕枢转销钩住的事实,本发明的所装配的设备在此应用中用作拉伸带,并且防止板分开,并且因此防止椎骨体从骨移植物材料分开。参见图27。
本领域的技术人员应该理解,本发明的“棘爪配合”结构可以允许外科医生首先安装融合器,并且随后在通过调节螺栓38调节一个或另一个或全部板部分允许的运动的程度之前简单地“棘爪配合”外部的板部分。替代地,能够在已经将板部分单独地调节到希望的外形之后调节螺栓。另外,螺栓结构允许为每个板部分提供不同程度的运动限制,或提供相同程度的限制。融合器的端部开口的性质允许容易地***骨生长刺激材料并且可以帮助建立坚固的椎骨到椎骨的融合。另外,如图18所示的分开的侧融合器部分相对容易***,并且可以当接近受限或困难时帮助外科医生建立和定位融合器。
融合器和板围绕共同的轴线(X)枢转的事实将帮助产生改进的负载传递。
除了上述内容之外,已经观察到,本发明的结构具有在其将要配合到的椎骨的外形的外部的相对低的外形,并且这可以提高设备在患者体内的寿命。
另外,应该理解,角度调节的简单的性质和能够“原地”进行角度调节的事实将消除许多其它技术共同的金属弯曲步骤,并且可以为椎骨结构提供好得多的程度的符合性。

Claims (33)

1.脊柱植入物,包括用于固定到椎骨体的上部的和下部的板部分,其中,所述板部分中的一个或多个是围绕轴线枢转的,以允许椎骨之间的可曲性。
2.根据权利要求1所述的脊柱植入物,包括用于抵抗所述一个或多个上部的或下部的部分的枢转运动的抵抗装置。
3.根据权利要求1或权利要求2所述的脊柱植入物,其中,所述板部分中的一个或多个包括所述抵抗装置与其接合的接合表面。
4.根据权利要求3所述的脊柱植入物,其中,所述植入物包括安装部分,并且其中,所述抵抗装置包括具有用于与所述一个或多个板部分摩擦接合的接合部分和用于与所述安装部分接合的螺栓螺纹的螺栓。
5.根据权利要求4所述的脊柱植入物,其中,所述抵抗装置包括所述螺栓的螺栓头部部分,并且所述一个或多个板包括在其中具有形成接合表面并且在操作中与所述螺栓头部接合的边缘的通道。
6.根据权利要求5所述的脊柱植入物,其中,所述板部分中的一个或多个包括半圆形的轴环部分,所述轴线包括杆部分,并且所述半圆形的轴环部分围绕所述杆部分接合以相对于所述杆部分枢转运动。
7.根据权利要求6所述的脊柱植入物,其中,所述上部的和下部的板部分每个包括半圆形的轴环部分,并且每个与所述杆部分接合以相对于所述杆部分枢转运动。
8.根据权利要求1到7中的任何一项所述的脊柱植入物,包括用于接收所述螺栓的螺栓螺纹的安装轴套。
9.根据权利要求8所述的脊柱植入物,其中,所述轴套包括杆部分,所述板部分中的一个或多个安装到所述杆部分上以相对于所述杆部分枢转运动。
10.根据前述权利要求中的任何一项所述的脊柱植入物,其中,所述一个或多个板部分上的所述一个或多个接合表面在所述一个或多个板的内部表面上。
11.根据权利要求7到10中的任何一项所述的脊柱植入物,其中,所述上部的或下部的板中的一个或多个包括用于与所述杆接合的“棘爪配合”配件。
12.根据权利要求1到11中的任何一项所述的脊柱植入物,其中,所述上部的和下部的板包括在其面对的边缘上的切口部分,所述螺栓头部包括延伸通过所述切口部分的轴线并且包括能够通过所述切口部分接近的接合特征部。
13.根据权利要求12所述的脊柱植入物,其中,所述螺栓头部具有大于所述切口的尺寸的直径。
14.根据权利要求7到13中的任何一项所述的脊柱植入物,其中,所述上部的板和所述下部的板每个包括一对轴环部分,并且其中,一对比另一对隔开更远,使得当与所述杆接合时,允许一对安置在另一对之间。
15.根据权利要求1到14中的任何一项所述的脊柱植入物,包括用于***椎骨之间的融合器部分。
16.根据权利要求1到5中的任何一项所述的脊柱植入物,其中,所述上部的或下部的板部分围绕共同的轴线X枢转。
17.根据权利要求15所述的脊柱植入物,其中,所述融合器包括用于代替椎骨的代替的融合器。
18.根据权利要求17所述的脊柱植入物,其中,所述融合器包括上部的和下部的杆部分。
19.根据权利要求1到18中的任何一项所述的脊柱植入物,其中,所述融合器部分包括具有侧臂的端部开口的融合器,并且其中,所述侧臂每个包括用于将所述融合器联接到所述板的联接件。
20.根据权利要求19所述的脊柱植入物,其中,所述植入物包括杆部分,所述板围绕所述杆部分枢转,并且所述联接件包括用于与所述杆部分接合的一个或多个切口。
21.根据权利要求20所述的脊柱植入物,其中,所述联接件包括用于与所述杆接合的一个或多个“棘爪配合”联接件。
22.根据权利要求9到21中的任何一项所述的脊柱植入物,其中,所述轴套部分在所述板部分的一个或其它板部分上。
23.根据权利要求1到22中的任何一项所述的脊柱植入物,包括用于将一个或其它板锁定在给定的角度位置的锁定装置。
24.根据权利要求23所述的脊柱植入物,其中,所述锁定装置包括在一个板部分上的用于与在所述其它板部分上的对应的表面摩擦接合的突出体。
25.根据权利要求23或24所述的脊柱植入物,其中,所述锁定装置包括在所述板部分的一个或其它板部分上的用于扩张和与所述其它板部分摩擦接合的可扩张的部分。
26.根据权利要求25所述的脊柱植入物,其中,所述可扩张的部分包括具有两个或更多片断的分开部分,和用于偏置所述片断分开并且与所述其它板部分接合的偏置装置。
27.根据权利要求1到26中的任何一项所述的脊柱植入物,其中,所述上部的或下部的板部分围绕共同的轴线X枢转。
28.根据权利要求1到27中的任何一项所述的脊柱植入物,其中,所述融合器包括一对隔开的独立式的侧部分14b、14c。
29.根据权利要求28所述的脊柱植入物,其中,所述侧部分在其下部的边缘处通过桥接部分14c链接。
30.根据权利要求1到29中的任何一项所述的脊柱植入物,包括具有移位的旋转轴线的一对轴线隔开的上部的和下部的板部分。
31.根据权利要求30所述的脊柱植入物,包括在所述上部的和下部的板部分之间的中间的板部分,并且安装为围绕所述下部的轴线枢转旋转。
32.根据权利要求1到30中的任何一项所述的脊柱植入物,包括板运动限制器。
33.根据权利要求32所述的脊柱植入物,其中所述限制器包括在所述上部的板上的内部的部分和在所述下部的板上的内部的部分,其中的每个围绕共同的轴线枢转,并且能够在板运动时在接合的和脱离的位置之间运动。
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KR20090101194A (ko) 2009-09-24
JP2010510852A (ja) 2010-04-08
US20100070037A1 (en) 2010-03-18
ZA200903570B (en) 2010-08-25
AU2007327046A1 (en) 2008-06-05
WO2008065443A1 (en) 2008-06-05
CN101610739A (zh) 2009-12-23

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