CN1143488A - 用于恢复脊柱正常解剖形态的体内融合装置及方法 - Google Patents
用于恢复脊柱正常解剖形态的体内融合装置及方法 Download PDFInfo
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- CN1143488A CN1143488A CN96105961A CN96105961A CN1143488A CN 1143488 A CN1143488 A CN 1143488A CN 96105961 A CN96105961 A CN 96105961A CN 96105961 A CN96105961 A CN 96105961A CN 1143488 A CN1143488 A CN 1143488A
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- fusing device
- main body
- oppositely arranged
- axle
- clamp
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- A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
- A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
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Abstract
一种介体融合装置包括形成有容纳骨植入物或替代材料的空心内腔和外螺纹部分被切平侧壁切断的锥状本体。侧壁设有血管形成开孔,壁上设有贯通本体对置的骨生长槽。植入物以大致相当于脊柱所需前凸角拧入椎骨间空间一个预定深度来恢复正常脊柱前凸。植入物适于从前方或后方插入,从前方插入则拧入就位,从后方插入则起凸轮作用将脊椎骨张开到合适脊柱前凸角。设有在切平侧壁部分在螺纹根部补成锥形以利于植入物拧入椎骨间空间内。
Description
本发明涉及一种用于放置到椎骨间的将损伤了的椎间盘取出之后留下的空隙中的人工植入物。具体地说,本发明涉及一种能便于相邻椎骨间的关节固定术或脊柱融合术、同时还能保持或恢复处于特定的椎骨水平上的正常的脊柱解剖形态的植入物。
在过去的几年中,为了排除引起下背部疼痛的因素而进行的脊柱手术的量稳步地增长。最常见的情况是,下背部的疼痛由相邻椎骨间的椎间盘损伤或病变引起。这些盘可能会突出或发生各种变性,这两种情况都破坏了椎间盘的解剖学上的功能。处理这类情况的最流行的外科方法是融合围绕着病变椎间盘的两块椎骨。在多数情况下,是通过椎间盘切除术将除纤维环以外的整个椎间盘都取出来。由于取出了损伤了的椎间盘,就必须将某些东西放入到盘内间隙中,否则这个间隙就会萎缩,造成沿着脊柱伸展的神经的损伤。
为了防止这种盘内间隙萎缩,就必须用骨或骨的替代物填充这一间隙,以便将相邻的两块椎骨融合起来。在早期的技术中,只是简单地将骨质材料放至相邻的椎骨之间,通常是放到椎骨的后部,利用一个横跨病变椎骨的板或杆来稳定脊柱。采用这样的技术,当形成了融合之后,用于维持脊柱部分的稳定性的部件就成了多余物了。况且,通过植入杆或板来稳定融合期间的脊椎水平所需要的外科手术常常既费时又复杂。
于是又提出,解决取出了椎间盘后的间隙的稳定性的更佳办法是:使椎骨在在它们各自的端板之间融合,最好是不需要使用前插板或后插板。人们进行了大量的努力来开发出一种既能用来代替损伤的椎间盘又能至少在形成完整的关节固定之前维持相邻椎骨之间的盘内间隙的稳定性的可接受的盘内间隙植入物。这些“体内融合装置”具有多种形式。例如,在几种更为流行的设计中的一种采用圆柱形植入物的形式。Bagby的4501269号美国专利、Brantigan的4878915号美国专利、Ray的4961740和5055104号美国专利以及Michelson的5015247号美国专利描述了这类植入物。如Ray、Brantigan和Michelson的专利所述,在这些圆柱形植入物中,圆柱体的外部刻有螺纹,以便插入体内融合装置。另一种方案是,某些融合植入物将被敲入到盘内间隙和椎骨端板中。Brantigan的美国第4743256、4834757和5192327号专利描述了这种类型的装置。
在上面举出的所有这些专利中,植入物的横截面在整个长度上都是恒定的,并且一般都是直立圆柱形的。还有人研制出了不具有恒定横截面的用于体内融合的其它植入物。例如,McKenna的美国第4714469号专利展示了一种带有伸至椎骨端板中的细长突出部的半球形的植入物。Kuntz的美国第4714469号专利展示了一种能优化该假体与相邻的椎骨体之间的摩擦配合的子弹头形的假体。最后,Babgy的美国第4936848号专利中的植入物是球形的,该植入物最好是放置在相邻椎骨的椎体之间。
体内融合装置大体上可分为两种基本类型,即实心的植入物和具有允许骨生长的结构的植入物。美国第4878915、4743256、4349921和4714469号专利描述了几种实心的植入物。上面讨论的其余的专利具有允许骨穿过植入物生长的某些技术特征。业已发现,利用能促进骨自然生长的装置能实现更快且更稳定的关节固定。Michelson的专利描述的装置是这类空心植入物的代表,通常在将这类植入物插入盘内间隙之前先用自体的骨填充它。这种植入物带有一些与该植入物的空心内腔连通的圆孔,由此在椎骨端板与位于植入物中的骨或骨的替代物之间形成一条供组织生长的通路。在预备盘内间隙时,最好是使端板减小,以便向骨供血,从而有利于这一组织的生长。在融合过程中,由Michelson的植入物提供的金属结构对维持待融合的运动段的开放性和稳定性起到了帮助作用。此外,一旦形成关节固定,植入物本身对实心骨体起到一种固定器的作用。
在现有的许多体内融合装置中仍然存在一些困难。尽管已经认识到使骨能够在植入物内的骨或骨的替代物中生长的空心植入物是实现融合的一种最佳技术装置,但多数已有装置难以实现这种融合,至少是在没有某些附加的稳定装置(如杆或板)的帮助下难以实现这种融合。此外,这些装置中的有一些在结构上不够结实,不能承受最为频繁地施加到被融合的椎骨水平(即下腰椎区的椎骨)上的沉重负荷及弯曲运动。
需要提供一种既能优化生长能力又具有足够的强度,在形成关节固定之前能一直支承脊柱段的空心的体内融合装置。本发明人已经发现,供骨生长的开口在防止应力保护嵌入在植入物中的自体骨方面起到了重要的作用。换句话说,如果骨生长孔的尺寸或形状不合适,自体骨便不能承受某种负载,已经发现,这种负载是确保快速及完整的融合所必需的。在这种情况下,嵌入在植入物中的骨可能重新吸收或发展成简单的纤维组织,而不是骨融合体,这将导致结构总体上的不平衡。另一方面,骨生长孔绝不能大到使壳体不具有足够的支承力、不能避免陷入到相邻椎骨中的程度。
上述已有装置没有解决的另一个问题涉及维持或恢复融合的脊柱段的正常解剖形态的问题。自然,一旦把椎间盘取出,脊柱的正常的前凸或后凸弧度就消失了。在已有装置中,对恢复这一弧度的需求被忽略了。例如,Babgy的美国第4501269号专利为代表的,如市售的、SpineTech的BAK装置中,相邻的椎骨体用装有特种植入物的圆柱形扩孔器扩孔。在某些情况下,在扩孔之前先建立正常的弧度,然后再插入植入物。图1示出了这种结构,图1显示了圆柱形的植入物插入到与安装植入物的盘内间隙相邻的基本上健康的椎骨中的深度。然而,由于取出了脊椎中的承重骨,又由于一般很难通过前凸最大的下腰段的后部扩孔,这种对后部过度扩孔的方法一般不被普遍接受。在采用这种植入物的大多数情况下,不做恢复前凸弧度的努力,因此,随着椎骨稳定在植入物的周围,这种圆柱形的植入物容易引起后凸变形。这种现象使脊柱失去平衡,因而常常导致重新进行手术。
由于已有装置的这些缺陷,因此仍然需要有一种既能优化骨生长能力又能保持其强度和稳定性的体内融合装置。另外还需要使这种植入物能够维持或恢复安放植入物的区段的正常的脊柱解剖形态。这种植入物必须具有足以支持并承受产生于处在安放植入物的水平上的脊椎上的沉重负荷的强度,同时在整个过程中应保持稳定。
针对已有装置遗留下来的仍未解决的问题,本发明设计了一种空心的带螺纹的体内融合装置,可用于恢复相邻椎骨间的正常的角度关系。具体地说,该装置具有一个细长的主体,该主体大体上沿着其整个长度呈锥形,并且具有一个空心的内腔,该主体的外径大于相邻椎骨之间的间隙。该主体具有一个外表面,所述外表面具有一些相对设置的、成锥形的圆柱形部分和一对在上述圆柱形部分之间的相对设置的、成锥形的平的侧表面。因此,从一端看来,该融合装置就象是一个圆柱形的主体,该主体的侧面是沿着主体外径的弦被截成平面的。在圆柱形的部分上开有螺纹,以便使该主体以受控的方式插入并接合到相邻椎骨的端板上。
在本发明的另一方面中,外表面沿其长度以一定的角度成锥形,在一个实施例中,这一角度与下腰椎的正常的前凸角一致。外表面上还具有一些在平的侧表面上形成的血管的开口,以及在圆柱形的部分上形成的一对相对设置的细长的骨生长槽。骨生长槽的横向宽度最好是在界定槽的范围内的圆柱形部分的有效宽度的一半左右。
本发明提供了一种用于将融合装置插入到盘内间隙中的驱动工具。在一个例子中,驱动工具包括一根轴,轴的一端具有一对彼此相对的成锥形的夹钳。这对夹钳借助一条铰合缝连接到轴上,所述铰合缝使夹钳张开以便将融合装置夹持在它们之间。驱动工具还具有一个围绕着所述的轴同轴设置的套筒,该套筒可以沿轴滑动,并挤压铰合缝,从而将这对夹钳往一起推,以便夹住融合装置。或者,可以采用一种内扩张弹性筒夹,在插入过程中从内部紧密地支撑住融合装置。
在驱动工具的一个方面中,成锥形的夹钳具有一个外表面,该外表面的形状与融合装置的成锥形的圆柱形部分的形状相同。夹钳还具有一个平的朝向内侧的、面向相应于融合装置的平的侧表面的表面。因此,当把夹钳压向融合装置时,夹钳的朝向内侧的表面与融合装置的平的侧表面接触,夹钳的外表面与融合装置结合成一个完整的圆锥形,以便于以拧入的方式将融合装置插入。夹钳的朝向内侧的表面上还可以有几个凸出的部分,用以与融合装置中的孔接合,以便将装置驱入并旋转到盘内间隙中。
在本发明的另一方面中,提供了一种将融合装置植入到相邻椎骨之间的方法。在一种方法中,是从前方插入,该方法包括扩张盘内间隙和在相邻椎骨的端板上钻出直径等于融合装置的螺纹内径的孔的步骤。插入一个套筒,构成钻孔步骤和后面的植入融合装置步骤的工作通道。将植入物与驱动工具结合,插入到套筒中然后拧入到准备好的孔中。锥形融合装置的插入深度决定了相邻椎骨达到的分开角度。
在另一种发明方法中,在后方预备插入点,即,从后方扩张盘内间隙,并在椎骨端板中钻一个内径孔。也用一个套筒来构成钻孔和插入步骤的工作通道。将融合装置插入到钻好的孔中,使其平的侧壁朝向相邻的椎骨。然后旋转该装置,使位于其圆柱形部分上的外螺纹切入并啮合在相邻的椎骨上。此外,由于融合装置是锥形的,该装置的锥形的外表面将使相邻的椎骨分开一定的角度,从而恢复正常的前凸解剖形态。
图1是已有技术中的融合装置的矢状面的侧视图;
图2是按照本发明的一个实施例的体内融合装置的放大透视图;
图3是沿3-3线剖取、沿箭头方向观看的图2所示的体内融合装置的侧剖视图;
图4是图2所示的体内融合装置的前端端面视图;
图5是图2所示的体内融合装置的顶视图;
图6是从脊柱的前方观看时的A-P侧视图,表示两个图2所示的体内融合装置被植入在位于L4与L5之间的体内间隙中时的情形;
图7是图6所示的植入在L4与L5之间的体内融合装置的矢状面的视图;
图8是按照本发明的体内融合装置的另一实施例的透视图;
图9是按照本发明的另一方面的植入驱动器的顶视图;
图10是植入驱动器的一端啮合在图2所示的体内融合装置上时的放大透视图;
图11是图10所示的啮合在体内融合装置上的植入驱动器的局部放大的侧剖视图;
图12是适合于与图10所示的体内融合装置啮合的另一实施例的植入驱动器的局部放大的侧剖视图;
图13(a)-13(d)表示根据本发明的另一方面的植入体内融合装置(例如图2所示的装置)的方法的四个步骤;
图14(a)-14(d)表示植入体内融合装置(例如图2所示的装置)的另一种方法的四个步骤。
为了使本发明的原理得到更好的理解,下面将参照附图所示的几个实施例并采用具体的语言来描述本发明。尽管如此,应当理解,这并不意味着对本发明的范围的限定,本发明所属领域的技术人员将会很自然地预料到附图所示的装置的变化和进一步的改进,以及其中所包含的本发明的原理的进一步的应用。
图2-5示出根据本发明的一个方面的体内融合装置10。该装置由一种坚硬的锥形主体11构成,主体11最好子是由一种生物相容性的或惰性的材料制成。例如,主体11可以由医用级的不锈钢或钛、或其它具有适合于上述强度特性的合适的材料制成。该装置也可由生物相容性的多孔材料,例如由ImplexCorp提供的多孔钽制成。为了便于参照,装置10具有一个前端12和一个后端13,它们与装置10植入在盘内间隙中时的解剖位置相对应。锥形主体11界定了一个空心的内部15,内部15由主体壁16围成,并且其前端13由端壁17封闭(见图3)。空心的内部15被做成可以接纳自体移植骨或骨的替代物的形状,能够促进相邻椎骨之间以及整个盘内间隙中的坚固的融合。
根据本发明,体内融合装置10是一个带有螺纹的装置,能够拧入到相邻椎骨间的端板中。在本发明的一个实施例中,椎形主体11限定了一组间断的外螺纹18和一条位于该值入物的前端的完整的螺纹19。完整的螺纹19充当将该植入物拧入到位于盘内间隙中的椎骨端板上的“起动”螺纹。螺纹18和19可以具有本领域中公知的几种形状,以便拧入到椎骨中。例如,这些螺纹可以具有三角形的横截面或截头三角形的横截面。螺纹的高度最好是1.0mm(.039in),以便在椎骨中提供足够的啮合力,使融合装置10不会被脊柱所受到的较高载荷推到盘内间隙之外。在一些具体的实施例中,螺距是2.3mm(0.091in)或3.0mm(0.118in),这取决于将要植入的装置10的所在椎骨水平和将植入物保持定位所需的啮合螺纹的数量。
在本发明的一个方面中,锥形主体11,特别是主体的外壁16,包括一对平行的平切的侧壁22,图4最清楚地示出了这一对平行侧壁22。这对侧壁最好是平的,以便于将该融合装置插入到相邻椎骨的端板之间,并形成一个供骨融合的区域。这对平切的侧壁从装置的前端12一直延伸到位于后端13的完整的螺纹19。这样,由于具有这对平切的侧壁22,装置10的端部呈不完整的圆形,这个圆形的两侧被沿着该圆的一条弦截去。在一个具体的实施例中,体内融合装置10的前端直径为16.0mm(0.630in)。在这个具体的实施例中,平切的侧壁22是沿着一对大约相距12.0mm(0.472in)的平行弦线形成的,因此,在该装置的两侧被截去的圆弧部分大约与90°的角相对。本文将更详细地描述由融合装置10的平切的侧壁22带来的益处及优点。
装置10的锥形主体11包括一对通过各个平切的侧壁22确定的形成血管的开口24和25。当融合装置被植入到盘内间隙中时,开口24和25将沿着侧向排列或朝向矢状面。这对开口将用于形成一条通路,以便能够在空心内腔15中的骨植入物与周围的组织之间形成血管。此外,有些骨还可能通过这些开口生长。开口24和25的尺寸既能保证为形成血管提供最佳通路,又能保留在锥形主体11中的大量结构,以承受贯穿相邻椎骨间的盘内间隙的较大的轴向负荷。
锥形主体11还确定了一些相对设置的骨生长槽27,所有这些槽都与平切的侧壁22成90°角。当装置10被植入时,这些槽27最好是直接与椎骨端板相邻。更具体地说,当装置的螺纹18和19被拧入到椎骨端板中时,椎骨将部分地延伸到槽27中与容纳在装置10的空心内腔15中的骨植入物接触。图5更清楚地示出,为了确保完整的关节固定和坚实的脊柱融合,骨生长槽27被做成能为骨生长提供最大开口的形状。这些槽的横向宽度最子是与主体的螺纹部分的有效宽度接近。业已发现,采用许多小缝隙的已有装置不能促进骨质材料的快速及坚实的关节固定。这些小的缝隙反而还常常导致假关节的形成以及纤维组织的生长。由于本发明的骨生长槽27直接面对着椎骨,它们不处于装置的必须承受较大负荷的部位上。取而代之的是,平切的侧壁22将要承受借助于间断螺纹18通过椎骨的两个端板之间并且贯穿盘内间隙的大部分的负载。
在进一步的特征中,在主体16的前端12上可以有一对沿径向相对的凹口29,这对凹口29的形状使得它们能与本文所述的植入驱动工具相配合。此外,在植入物的后端13的端壁17上也可以带有一个与工具配合的部件(未示出)。例如,如本文将进一步描述的那样,可以开一个六边形的凹槽来接纳一个六边形的驱动工具。
本发明的体内融合装置的一个重要特征是,主体11是成锥形或圆锥形的。换句话说,该装置的前端12的外径大于其后端13的外径。如图3所示,主体壁16围绕着装置10的中线CL以角度A成锥形。成锥形的主体壁16有助于恢复相邻椎骨之间的正常的相对角度。例如,在腰部,角度A有助于恢复位于这个部位的脊柱的正常的前凸角度和弯曲度。在一个具体的例子中,角度A为8.794°。不难理解,植入物可以具有一些非锥形的部分,只要这些部分不会影响锥形主体的功能即可。
植入物的锥角A与融合装置10的前端及后端的外径结合起来,确定了当植入物被放入或拧入到它所处的位置中时将会在相邻椎骨之间形成的角发散的量。图6和图7更清楚地示出了这一特征,这两幅图示出了采用一对融合装置10的优选结构。在图示的结构中,装置10被放置在下腰椎L4和L5之间,螺纹18和19拧入在两个椎骨的端板E中。如图7所示,当装置10被拧入端板E中时,它沿着箭头E的方向朝着椎骨水平的枢轴P前进。枢轴P名义上是运动段的相邻椎骨之间的相对旋转的中心。随着锥形融合装置10进一步沿着箭头I的方向朝着枢轴P前进,相邻椎骨L4和L5朝着箭头S的方向成角度地散开。融合装置10的插入深度将决定相邻两椎骨之间达到的最终前凸角L。
在装置10的几个具体实施例中,前端12的外径或螺纹牙顶的直径可以是16、18或20mm,装置的全长为26mm。装置的尺寸由将要植入该装置的椎骨的水平和必须达到的角度决定。
在本发明的另一方面中,如图6所示,装置10的尺寸使得两个这样的圆柱形主体11可以被植入到一个盘间隙中。这样就能在这两个装置10之间或周围放入另一种骨融合材料。这一特性还促进了整个盘内间隙中的融合,并能将装置更坚实地固定到相邻的椎骨之间,防止该装置被该特定的椎骨水平上的较高负荷挤出去。
在体内融合装置的一个具体实施例中,形成血管的开口24总体上呈矩形,其尺寸为6.0mm(0.236in)乘7.0mm(0.276in)。同样,形成血管的开口25也呈矩形,其尺寸为4.0mm(0,157in)乘5.0mm(0.197in)。自然,这一开口要小一些,因为它位于装置10的较小的后端13。骨生长槽27也是矩形的,其长为20.0mm(0.787in),宽为6.0mm(0.236in)。业已发现,形成血管的开口24、25和槽27的这些尺寸对骨生长和血管形成是最佳的。此外,这些开口的尺寸并不太大,它们兼顾了装置的结构整体性,或者它们使得容纳在空心内腔15中的骨融合材料在植入过程中能够较容易地被排出来。
如图7所示,当装置被定位在L4和L5椎骨之间时,形成血管的开口24和25在侧面与椎骨周围的形成丰富血管的组织相接触。并且,如图6所示,骨生长槽27朝向轴向,因此与椎骨端板E接触。
在图8所示的本发明的另一实施例中,体内融合装置30由一个锥形的主体31构成。和前面的实施例中的融合装置10一样,主体34限定了一个空心内腔33。但是,在这个实施例中,平切的侧壁38上不带有形成血管的开口。并且,位于装置10的相对两侧的骨生长槽34比较小。这意味着位于装置30的外部的间断螺纹36围绕着植入物延伸更长的一段距离。如果采用多孔材料(例如钽)来形成供组织生长及固定到相邻骨上的辅助表面,则可以采用这样的设计。图8所示的实施例的体内融合装置30还可以应用于某些椎骨水平,在这些水平上,装置被挤出去的风险最大。因此,通过增加螺纹的接触量来防止发生这类的挤出。在插入之前,先在装置10的空心内腔15中填满骨或替代物,以便为这样的预加载提供方便。
根据本发明的一个方面,可以利用图9所示的植入驱动器50将体内融合装置10植入体内。植入驱动器50由一个轴51和一个围绕着该轴同心设置的轴套52构成。轴的一端带有一些夹钳54,用于夹持体内融合装置10以便将其植入。夹钳具有一个成锥形的外表面55和一个平的内表面56,适合于与体内融合装置的平切的侧壁22配合。锥形的外表面55与间断螺纹18的根径一致,因此夹钳54基本上填满主体壁16的整个圆柱形状。由于外表面55将跨接在位于椎骨端板内的开了螺纹的孔中,所以夹钳的锥形外表面55促进了体内融合装置10的拧入。
每个夹钳都带有从内表面56伸出的联锁销58和驱动凸块59。图11更清楚地示出了这些部件的功能。先看图9,轴51上带有一个支撑一对夹钳54的铰合缝62。铰合缝62具有这样的形状;它使夹钳处在一个分散得足够开的自然偏斜的状态,能够将锥形体内融合装置10接纳在夹钳之间。轴51限定了一个位于铰合缝62和各夹钳54之间的锥形部分63。这个锥形部分与位于轴套52的内壁上的锥形槽67匹配。因此,当使轴套52朝着夹钳54的方向前移时,锥形槽67倚靠着锥形部分63,从而封闭或压挤铰合缝62。以这样的方式,夹钳54受到使它们彼此靠近的推力,并且在压力的作用下将位于两夹钳之间的体内融合装置夹紧。
轴51和轴套52具与带螺纹的界面65,使轴套52能够沿轴的长度方向拧到轴上或从轴上拧下。具体地说,带螺纹的界面65包括位于轴51上的外螺纹和位于轴套52上的内螺纹,所述内、外螺纹具有相同的螺距,因此轴套可以方便地从植入驱动器上移上移下。轴51还带有一对止动销69,它们将轴套52的后移限制在一个范围内,这个范围仅仅是为了接纳体内融合装置10而使夹钳54独立出一段足够的距离所需的移动范围。
图10和11示出了植入驱动器的使用过程。如图10所示,夹钳54的外表面55处在基本上与间断螺纹18的根径平接的位置上。如图11所示,可以将两个止动销58安置到位于各平切的侧壁22上的形成血管的开口24中。以同样的方式,驱动凸块59与位于锥形主体11的前端12上的容纳驱动工具的凹口29啮合。联锁销58和驱动凸块59相结合,将体内融合装置10紧紧地夹持住,从而可以将该装置拧入到位于脊椎骨中的攻了丝的或未攻丝的开口中。
图12示出了植入驱动器的另一实施例。驱动器90包括一个轴91,其长度足以保证其从病人体外伸至盘内间隙中。一个限定了一对彼此相对的夹钳93的头部与轴91的端部相连,各夹钳的形状使得它们能够与融合装置10的平的平切的侧壁22平接。与前面所述的植入驱动器50的两个夹钳54一样,夹钳53的外表面呈圆柱形,以便与装置的圆柱形螺纹部分一致。
与值入驱动器50不同,图12所示的实施例中的驱动器90利用一个可扩张的弹性筒夹组件来紧紧地卡持住融合装置10以便将其插入到身体中。具体地说,头部92限定了一个弹性筒夹94,弹性筒夹94具有一个贯穿于其中的中心套孔95。弹性筒夹94的一端是一个环形凸缘96,环形凸缘96至少在最初具有稍小于融合装置10的端部12的内径的直径。一根扩管轴97以可滑动的方式贯穿所述的套孔,并且带有一个加大的端部98,端部98靠近环形凸缘96并且刚刚伸至环形凸缘96之外。扩管轴97的加大的端部98在其起始端的直径较小,使其能够在套孔95中滑动,从该起始端开始,端部98的直径逐渐加大至大于所述套孔的直径。
植入驱动器90包括一个拆卸工具轴99,所述的轴99以可以滑动的方式设置在由轴91限定的孔100中。在拆卸工具轴99的端部有一个与扩管轴97的端部上的锁定毂102接合的锁定腔101。拆卸工具轴99伸至轴91的端外,供外科医生持握。当把拆卸工具轴99拉出时,它便将扩管轴97从套筒94的环形凸缘96中向外拉,从而使加宽的端部98逐渐地接合在套孔95中。随着端部98进一步前移至套孔95中,环形凸缘97从初始直径扩大至一个更大的第二直径,足以紧紧地卡持住融合装置10的内腔。通过使植入驱动器以这种方式与融合装置接合,可以将装置10插入至手术区中,然后,可将扩孔轴推至套孔之外以释放加大端,从而将融合装置松脱开。
本发明设计了两种值入体内融合装置10的方法。首先,图13(a)-13(d)示出了前方插入法。在预备步骤中,需要定下植入融合装置的合适的、最好是双侧的起点。在这前方插入法的第一步中,先将一个扩张器75放置到椎骨的两个端板E之间以扩张L4和L5之间的盘间隙。(当然,应该理解,这一步骤也可用于其它的椎骨水平)。在图12(b)所示的第二步骤中,将一个套筒76放置到盘间隙周围。可以按公知的方法设计套筒76的形状,使其能够与椎骨主体的前部可靠地接合,以便牢固地、但又是暂时地使套筒76定位。实质上,在这种腹腔镜(laproscopic)式的植入法中,套筒76起的是一个工作通道的作用。在图12(b)所示的这个步骤中,将一个公知的钻头77插到套筒中,用该钻头在这两个相邻的椎骨中钻出孔。也可以在这些孔中攻丝,以便于将融合装置拧入,尽管这一步骤并不是必不可少的。
在图13(c)所示的下一个步骤中,用植入驱动器5夹持住融合装置10,并将其插至套筒76中,直到起动螺纹19接触到骨上的开口。然后,可以用植入驱动器50将融合装置10拧入到开在椎骨端板中的攻了丝的或未攻丝的孔中。应该理解,在这个步骤中,也可以利用其它合适的驱动工具,如螺纹驱动器型的装置,与位于装置10的前端12的驱动工具凹槽29接合。如前面所述,融合装置10的插入程度决定了加在这个脊椎水平上的、或者是使这个脊椎水平恢复的脊柱前凸的量。在最后的步骤中,将植入驱动器取出,使融合装置10留在原位。可见,一旦被植入,封闭的端壁17便朝向该椎骨的后端。位于前端的空心内腔15是敞开的,但必要的话可以用金属或塑料材料将其封闭住。
在第二种发明方法中,图14(a)-14(d)示出了后方插入法。后方插入法的前面两个步聚与前方插入法相似,不同的只是,扩张器75、套筒76和钻头77是从后面放入安放植入物的区域中的。这种插入法可能需要将椎骨剥离或移开以便接纳套筒76。在该方法的第三步中,将融合装置10通过套筒76插入到扩张的盘间隙中。应该理解,只需将盘间隙扩张到一定的程度,这一程度是接纳具有直接面对椎骨端板E的平切的侧壁22的植入物所必须的。因此,如图14(c)所示,骨生长槽27朝向侧向,而不是朝向横向,与其预期的植入位置一致。可以利用一种合适的驱动工具80使融合装置10通过套筒76伸出,并进入到盘内间隙中。在一个实施例中,驱动工具80带有一个凸出部81,其形状与开在融合装置10的后端13的端壁17上的凹口吻合。也可以利用外螺纹(未示出)将装置10固定到驱动器80上。
一旦将融合装置10推入盘内间隙中并相对于椎骨的枢轴P到达了合适的深度,就可利用驱驱动工具80沿图14(c)中箭头R所指的方向转动该植入物。随着驱动工具80的旋转,装置本身也旋转,使间断螺纹18开始切入到位于端板E处的椎骨中。以这样的方式,植入物象一个凸轮一样沿着沿图14(c)中箭头S所指的分散方向将相相邻的椎骨分开。由于只需一次旋转就可将植入物锁定到椎骨中,所以,这种凸轮式插入从某种程度上说是一种较为简便的插入方法。相反,前面讨论的螺纹式插入技术需要将装置连续地拧入至其位置上。
采用这两种技术中的任何一种,都可以利用X-射线或其它合适的技术来检验融合装置10相对于与之相邻的椎骨的位置,从而建立椎骨之间的角度关系。或者,可以预先确定优选的植入物插入深度,并且在将植入物放入椎骨之间时从病人体外测定这一深度。
可见,本发明的体内融合装置10、植入驱动器50以及本发明的方法比已有的装置技术具有显著的优点。具体地说,融合装置10是一个带螺纹的空心插入物,最大限度地挖掘了相邻椎骨间的骨融合潜能,同时保持了植入物本身的整体性。应该理解,脊柱在其轴向上要承受相当大的负荷,至少在达到坚实的融合之前,这种负荷都必须由融合装置10来承受。装置10还带有供血管形成及组织生长的部件,这些部件加速了融合的速度,提高了融合成的骨质的强度。另一个显著的方面是,植入物的锥形形状使外科医生能够恢复和维持椎骨体之间的合适的弧度或相对的角度。这就可以避免出现产品变形、脊柱失去平衡这类的与已有装置有关的严重问题。本发明的装置及植入驱动器的另一个优点是,利用一种腹腔镜式的插入方法既可以从前部也可以从后部将其插入。根据椎骨水平,两种插入方法都是可取的,因此,重要的是,植入物要适合于从这两个方向插入。在前方插入法中,利用旋入技术(与敲入相对照)来控制装置的插入,在后方插入法中,用滑入及凸轮式的方法来空制装置的插入。
尽管已经利用附图和前面的描述展示并阐述了本发明,但这些附图和描述仅仅是说明性的而不是限定性的,应当理解,前面只是显示并描述了优选的实施例,落入本发明的构思范围的所有变化和改进都应当受到保护。例如,尽管只是公开了装置10用于脊柱的情况,但本发明的结构和方法还可用于其它关节间隙中,例如踝关节、腕关节和subtalar关节。此外,尽管在优选实施例中显示的装置10在其整个长度范围内都是锥形的,但是在所得到的装置上加上非锥形的或者倒锥形的部分仍然落入本发明的范围。
Claims (27)
1、一种融合装置,用于便于在相邻椎骨间的盘间隙中进行的关节固定术,包括:
一个细长的主体,所述主体具有一个长度和一个在其第一端处的第一直径,所述第一直径大于相邻椎骨间的间隙,所述主体还限定了一个用于在其内接纳骨融合材料的空心内腔;
所述主体具有一个外表面,所述的外表面具有一对相对设置的圆柱形部分和位于所述的这对相对设置的圆柱形部分之间的一对基本上平直的相对设置的侧壁,所述侧壁沿着所述主体的所述长度的实体部分延伸;
在所述外表面的所述一对相对设置的圆柱形部分上带有外螺纹,所述螺纹基本上沿着述主体的全长延伸。
2、如权利要求1所述的融合装置,其特征在于,所述主体沿着所述长度的一个实体部分成锥形,并且在其第二端处的第二直径大于所述的第一直径。
3、如权利要求1所述的融合装置,其特征在于,在所述的相对设置的侧壁上开有几个与所述的空心内腔连通的孔。
4、如权利要求3所述的融合装置,其特征在于,还包括通过所述圆柱形部分中的所述螺纹界定的、并且与所述的空心内腔相通的一对沿径向相对设置的槽,所述的相对设置的槽沿着所述主体的所述长度方向延伸,并且比所述的几个孔大。
5、如权利要求1所述的融合装置,其特征在于,还包括通过所述圆柱形部分中的所述螺纹界定的、并且与所述的空心内腔相通的一对沿径向相对设置的槽,所述的相对设置的槽沿着所述主体的所述长度方向延伸。
6、如权利要求5所述的融合装置,其特征在于,所述的相对设置的槽呈矩形,并且具有横过所述主体的所述长度的宽度尺寸;并且,
所述的圆柱形部分具有位于所述侧壁和所述的相对设置的槽之间的有效宽度,
其中,所述相对设置的槽的所述宽度尺寸大于所述的圆柱形部分的所述有效宽度。
7、如权利要求1所述的融合装置,其特征在于:
所述的平直侧壁终止于所述的第一端附近;并且
所述圆柱形部分和所述螺纹被所述的侧壁中断,然后又在所述的第一端环绕着连接起来。
8、如权利要求1所述的融合装置,其特征在于所述的主体在所述的第一端是封闭的,而在与所述第一端相对的第二端则向所述的空心内腔敞开。
9、如权利要求1所述的融合装置,其特征在于所述的主体具有一个与所述第一端相对的第二端,所述的第二端向着所述的空心内腔敞开。
10、如权利要求7所述的融合装置,其特征在于:
所述的主体具有一个与所述第一端相对的第二端;并且
所述的平直侧壁终止于所述的第二端。
11、如权利要求10所述的融合装置,其特征在于,所述的相对设置的壁各自限定了一个位于所述第二端的凹口,所述凹口可以用于接纳一个植入所述装置的驱动工具。
12、一种融合装置,用于便于在相邻椎骨间的盘间隙中进行的关节固定术,包括:
一个细长的主体,所述主体具有一个长度,一个在第一端处的第一直径和一个在与所述第一端相对的第二端处的较大的第二直径,所述的第一和第二直径大于相邻椎骨间的间隙,所述主体还限定了一个用于在其内接纳骨融合材料的空心内腔;
所述主体具有一个从所述第一直径逐渐变为所述第二直径的外表面,所述的外表面上带有外螺纹,所述外螺纹基本上整个地沿着所述主体的所述长度延伸。
13、如权利要求12所述的融合装置,其特征在于,还包括通过所述外表面中的所述螺纹界定的、并且与所述的空心内腔相通的一对沿径向相对设置的槽,所述的相对设置的槽沿着所述主体的所述长度方向延伸。
14、如权利要求12所述的融合装置,其特征在于所述的主体在所述的第一端是封闭的,而在所述的第二端则向所述的空心内腔敞开。
15、一种驱动工具,用于将体内融合装置植入到相邻椎骨之间的间隙中,所述的融合装置具有一个主体,所述的主体具有一个被相对设置的平直侧壁断开的圆柱形外表面,所述的外表面上带有外螺纹,所述的工具包括:
一个细长的轴;以及
一对通过铰接件与所述轴的一端连接的、彼此相对的夹钳,所述的夹钳彼此偏离开;
所述夹钳中的每一个都具有一对被成形得能够与融合装置的相对设置的平直侧壁接触的向内的表面和一对被成形得能够与融合装置的圆柱形外表面相一致的向外的表面。
16、如权利要求15所述的驱动工具,其中的融合装置带有开在平直的侧表面上的开口,其中,每个所述的夹钳的所述向内的表面都带有一个从该表面伸出的销子,当所述的向内表面与所述的平直侧表面接触时,所术的销子将伸入到融合装置的平直侧表面上的几个开口之一中。
17、如权利要求15所述的驱动工具,其特征在于,还包括一个围绕着所述的轴同轴设置的轴套,所述的轴套可以在所述的轴上滑动,从而挤压所述的铰合件,以便将所述的夹钳彼此推近,由此,所述的夹钳将位于它之间的融合装置夹紧。
18、如权利要求17所述的驱动工具,其特征在于,所述的轴套借助于螺纹接合在所述的轴上,因此,当使所述的轴套围绕着螺纹接合处旋转时,所述的轴套会沿着所述轴的长度方向轴向地移动。
19、如权利要求17所述的驱动工具,其特征在于:
所述的夹钳带有一个与所述铰合件相邻的锥形表面;并且
在所述轴套的内表面上有一个锥形的槽,所述的锥形的槽与所述的锥形表面互补,因此,当所述的轴套朝着所述的夹钳轴向移动以挤压所述的铰合件时,所述的锥形槽也随之沿着所述的锥形表面移动。
20、如权利要求15所述的驱动工具,其中所述的融合装置具有一对开在其一端中的相对设置的凹口,其中,所述的夹钳带有一些从所述的向内表面伸出来的驱动凸块,所述的驱动凸块可以和融合装置中的相对设置的凹口啮合。
21、一种驱动工具,用于将体内融合装置植入到相邻椎骨之间的间隙中,所述的空心的融合装置具有一个主体,所述的主体具有一个圆柱形内表面和一个被相对设置的平直侧壁断开的圆柱形外表面,所述的外表面上带有外螺纹,所述的工具包括:
一个细长的轴;以及
一对与所述轴的一端连接的、彼此相对的夹钳,所述的夹钳彼此偏离开以便将融合装置的相对设置的平直侧壁接纳在它们之间;以及
一个与所述的细长的轴相连的可扩张的弹性筒夹组件,所述的组件具有这样一个部分,该部分能够从一个小到使其可以置身于该空心的融合装置的内腔中的第一直径扩大到一个较大的、使其能够卡持住融合装置的内腔的第二直径。
22、如权利要求21所述的驱动工具,其特征在于所述的可扩张的弹性筒夹组件包括:
一个与所述的一对相对的夹钳成为一体的头部,所述的头部具有一个贯穿于其中的中心孔和一个位于所述孔的一端的与所述的夹钳相邻并位于所述夹钳内侧的环形凸缘;以及
一个以可滑动的方式设置在所述的中心孔之中的扩管轴,所述的扩管轴具有一个端部,当所述的扩孔轴被放置在所述的中心孔中时,该端部从一个小到使其能够在所述的中心孔中滑动的第一直径扩大到一个与所述的环形凸缘相邻的较大的第二直径,
由此,当所述的扩孔轴缩入到所述的中心孔中时,所述的扩大的端部使所述的环形凸缘逐渐地扩张到与融合装置的内腔啮合的程度。
23、一种将一个融合装置植入到相邻椎骨之间的盘内间隙中的方法,包括以下步骤:
a)提供一个空心的融合装置,该融合装置具有一个被相对设置的平直侧壁断开的圆柱形外表面,在该处表面上开有外螺纹;
b)用骨融合材料填充该融合装置的内腔;
c)在相邻的骨中钻一个直径等于融合装置的外螺纹的根径的孔;
d)将融合装置插入到钻好的孔中,使平直的侧表面朝向相邻的椎骨;以及
e)旋转位于孔中的融合装置,使外螺纹与相邻的椎骨啮合。
24、如权利要求23所述的方法,其特征在于:
提供空心的融合装置的步骤包括,提供一个从一个较大的第一端逐渐缩小到一个较小的第二端的融合装置;以及
插入融合装置的步骤包括,插入这个装置使得该装置的锥度与相邻椎骨间的正常的解剖学角度关系一致。
25、如权利要求24所述的方法,其特征在于插入和钻孔步骤都是从后方进行的。
26、如权利要求24所述的方法,其特征在于还包括提供一个与相邻的椎骨接触并对准盘内间隙的套筒的步骤,以便为钻孔和插入步骤提供一个工作通道。
27、一种将一个融合装置植入到相邻邻椎骨之间的盘内间隙中的方法,包括以下步骤:
a)提供一个空心的融合装置,该融合装置具有一个圆锥形的外表面,在该外表面上开有与骨啮合的外螺纹;
b)在位于盘内间隙对侧的椎骨端板中钻一个孔,该钻孔的直径等于融合装置的外螺纹的根径;
c)将融合装置拧入到钻好的孔中达到一个预定的深度,使相邻的椎骨被融合装置的锥形的外表面分开一定的角度,从而恢复相邻椎骨间的预定的角度关系。
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Application Number | Priority Date | Filing Date | Title |
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US411017 | 1995-03-27 | ||
US08/411,017 US5782919A (en) | 1995-03-27 | 1995-03-27 | Interbody fusion device and method for restoration of normal spinal anatomy |
US08/413,353 US5669909A (en) | 1995-03-27 | 1995-03-30 | Interbody fusion device and method for restoration of normal spinal anatomy |
US08/603,674 US5984967A (en) | 1995-03-27 | 1996-02-19 | Osteogenic fusion devices |
US79911497A | 1997-02-11 | 1997-02-11 | |
US09/489,317 US6375655B1 (en) | 1995-03-27 | 2000-01-21 | Interbody fusion device and method for restoration of normal spinal anatomy |
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CNB2004100286166A Division CN100425214C (zh) | 1995-03-27 | 1996-03-26 | 用于植入体内融合装置的驱动工具 |
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CNB961059664A Expired - Lifetime CN1142751C (zh) | 1995-03-27 | 1996-03-26 | 用于恢复脊柱正常解剖形态的体内融合装置 |
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EP (3) | EP1325719A3 (zh) |
JP (2) | JP3821876B2 (zh) |
CN (2) | CN1146369C (zh) |
AT (2) | ATE240703T1 (zh) |
AU (2) | AU705991B2 (zh) |
CA (2) | CA2171907C (zh) |
DE (2) | DE69628352T2 (zh) |
ES (2) | ES2197135T3 (zh) |
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1996
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- 1996-03-15 CA CA002171921A patent/CA2171921C/en not_active Expired - Fee Related
- 1996-03-22 MX MX9601078A patent/MX9601078A/es unknown
- 1996-03-25 AU AU48292/96A patent/AU705991B2/en not_active Ceased
- 1996-03-26 CN CNB961059613A patent/CN1146369C/zh not_active Expired - Lifetime
- 1996-03-26 NO NO961214A patent/NO961214L/no unknown
- 1996-03-26 CN CNB961059664A patent/CN1142751C/zh not_active Expired - Lifetime
- 1996-03-26 TR TR96/00242A patent/TR199600242A2/xx unknown
- 1996-03-26 NO NO961213A patent/NO961213L/no unknown
- 1996-03-27 EP EP03075221A patent/EP1325719A3/en not_active Ceased
- 1996-03-27 DE DE69628352T patent/DE69628352T2/de not_active Expired - Lifetime
- 1996-03-27 EP EP01202672A patent/EP1147751B1/en not_active Expired - Lifetime
- 1996-03-27 EP EP96302092A patent/EP0734703B1/en not_active Expired - Lifetime
- 1996-03-27 ES ES01202672T patent/ES2197135T3/es not_active Expired - Lifetime
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- 1996-03-27 JP JP07245396A patent/JP3821876B2/ja not_active Expired - Fee Related
- 1996-03-27 DE DE69619007T patent/DE69619007T2/de not_active Expired - Lifetime
- 1996-03-27 AT AT01202672T patent/ATE240703T1/de not_active IP Right Cessation
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1997
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2000
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CN101166486B (zh) * | 2005-04-29 | 2010-10-06 | 华沙整形外科股份有限公司 | 脊柱植入物的人造承重胶原-矿物质复合材料 |
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