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CN1541082A - 供脊柱融合手术中使用的椎间空间植入物 - Google Patents

供脊柱融合手术中使用的椎间空间植入物 Download PDF

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Publication number
CN1541082A
CN1541082A CN 02810648 CN02810648A CN1541082A CN 1541082 A CN1541082 A CN 1541082A CN 02810648 CN02810648 CN 02810648 CN 02810648 A CN02810648 A CN 02810648A CN 1541082 A CN1541082 A CN 1541082A
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CN
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Patent type
Prior art keywords
intervertebral
space
implant
use
spinal
Prior art date
Application number
CN 02810648
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English (en)
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CN100358485C (zh )
Inventor
布雷德利J・格伦
布雷德利J·格伦
な┠蔚侣
加里A·施奈德曼
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德普伊阿克罗米德公司
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    • 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
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    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y10S606/907Composed of particular material or coated
    • Y10S606/91Polymer

Abstract

提供一种植入物装置(10),用于将其外科植入椎间空间(S)中,例如用于在脊柱融合手术期间稳定邻近该椎间空间(S)的椎骨。植入物装置(10)包括一个与一第二部件(60)分开的第一部件(20)。这些部件(20,60)是细长而截面足够小的,以便它们能以侵害最小的方式后植入。第一部件(20)最好包括一孔道(30),而第二部件(60)最好包括一颈部(70),孔道(30)和颈部(70)的尺寸是互补的,使得当其在颈部(70)于孔道(30)中相交时部件(20,60)能互相稳定。这样提供的整个植入物装置(10)既能扩大又能支撑椎间空间(S),并足够刚性而能当椎骨(V)融合在一起时对椎间空间(S)提供充分的支撑。

Description

供脊柱融合手术中使用的椎间空间植入物

技术领域

本发明涉及植入物,其形状能安置在从相邻的脊柱椎骨之间的椎间空间内移去一椎盘后的该椎间空间中并便于使椎骨融合在一起。更具体地说,本发明涉及能以侵害最小或开口最小的方式从后部植入,并使与该椎间空间相邻的椎骨彼此分开地扩展而重新创造腰脊柱前凸,且当椎骨融合在一起时支撑这些椎骨。

技术背景已知脊柱融合手术是某些脊柱疾病的有效治疗方法。通常,此种脊柱融合手术可能涉及移去两块相邻椎骨之间的椎间空间中的椎间盘。在已移去该椎盘后,可以在该椎间空间中安置一个植入物来推动两边的椎骨分开。通过推动椎骨分开,椎骨周围的韧带和其它人体构造受到张力而往往与植入物一起将这两块椎骨牢固地保持在彼此相对的固定位置中。尽可能恢复该椎间空间的高度是重要的。恢复该椎间空间的角度或“脊柱前凸”也是重要的。最后,将融合材料安置在该椎间空间内,该融合材料能诱生该椎间空间中的骨头生长,从而与通常保持埋置在该融合的椎骨组合中的植入物一起有效地融合这两块椎骨。

将植入物安置在椎间空间中是以两种普遍方法之一完成的。第一种方法是通过对病人进行腹部/胸部外科手术并从病人前侧接近该椎间空间,可以从前部接近该椎间空间。在该前部手术中,通常涉及主要的腹部/胸部外科手术。但是,通常能从前部接近该椎间空间,从而大大降低损伤神经的风险,而且外科手术在将植入物精确地安置于所要部位方面具有更大的灵活性。

第二种方法是,该植入物能够从后部插入。直接的后部接近该椎间空间要求向着中线移动椎管内的脊柱神经并可能导致损伤神经或结疤。在椎间空间中的植入也能够从脊柱左侧或右侧的位置接近并以一个角度伸入椎间空间中。该途径避开了椎管。能够使用一种利用小切口的侵害最小的方法,但必须小心完成以避开敏感的脊柱构造。此外,由于椎骨构造之间的间隙量很小,通常需要尺寸较小的植入物。因此,椎骨与一个后部植入物的扩展量常常不够充分。此外,通常需要至少部分切开一部分椎骨,以提供在将植入物从后部插入椎间空间中所必需的通道。

用于椎间空间的植入物有各种不同构型,大多数设计用于前植入。Sertich的美国专利No.5,800,550详细描述了一种已知的先有技术植入物。Sertich植入物做成从后部植入并分成两部件。在脊柱的两侧做两个独立的切口,将整个植入物的两部件基本上互相平行地插入,但可以稍许偏离平行方向一个角度。Sertich植入物的两部件具有矩形截面和细长形状。两部件首先以较小的尺寸垂直取向地植入,使得两部件能够容易地进入椎间空间。两部件然后旋转90度,使得较大的尺寸转到垂直方向,以便沿垂直方向扩展椎骨以增大椎间空间。

Sertich说明的植入物不完全理想。因为Sertich植入物涉及两个完全独立的部件,所以它们无论怎样也不会彼此稳定,因而不能提供理想份量的椎骨稳定。此外,两部件植入的相当平行的角度需要移去一部分椎骨和卷缩脊柱神经,以合适地植入Sertich植入物的两部件。如果植入物的两部件彼此角度更大,它们提供给椎骨的稳定性往往进一步减小。同时,Sertich植入物两部件的尺寸要求相当大的切口来插入到椎间空间内。

因此,需要一种在插入时具有小的截面而一旦安置后还能在相邻的椎骨间提供大的位移量的后置的椎间空间植入物。该植入物必须扩张得足够远地分开以恢复该椎间空间的高度,并在完成移植后基本上起该椎间空间内一个单独的刚性构造的作用。这样一种发明的额外优点是能够在前区中具有更大的高度,使得能够以外科手术所要的量来获得脊柱前凸,使椎间空产的前侧大于椎间空间的后侧。

发明的公开内容本发明是一种椎间空间植入物,其形状做成能以侵害最小或开口最小的外科手术后置地植入。该植入物包括含第一部件和第二部件的两个独立部件。第一部件和第二部件通过脊柱两侧不同的切口沿在该椎间空间中相交的路径进入该椎间空间。为了用植入物增大该椎间空间的扩展,两部件在底面和顶面之间的高度大于其侧向宽度。因此能以顶面和底面互相沿侧向隔开的方式引入两部件,而后旋转90度,使顶面位于底面上方,使部件的高度达到最大。

第一部件和第二部件相交的相邻部分是除去的,使两部件安置在基本上共同的平面内。最好是,第一部件包括一个在其中点附近沿侧向通过第一部件的孔道。第二部件在其中点附近有一颈部,该颈部的高度小于第二部件的其它部分。该孔道的尺寸能使第二部件穿过第一部件的孔道然后旋转而使第二部件的颈部安置在第一部件的孔道中。

在第二部件已旋转后,两部件成交叉图形联锁在一起,从而形成本发明的植入物装置。因此,本发明的植入物装置的优点是,具有相当低的外形轮廓,以便以侵害最小的方式后置地插入,但仍形成一个具有联锁在一起的独立的两部件的总体的植入物装置,从而形成一个单独的基本上刚性的植入物装置,以最大地稳定与该椎间空间相邻的椎骨。

此外,两部件的形成方式便于两部件在植入后的高度的扩张,特别在两部件的远端处。此种补充的高度的扩张进一步稳定与该椎间空间相邻的椎骨,并对该椎间空间提供脊柱前凸。

具体地说,第一部件的形状最好是有一与底面隔开的顶面,它们彼此相对地枢轴式转动,比如围绕一枢轴转动。一个通道穿过该顶部构造和底部构造之间。一个填隙片能够沿该通道通过,当该填隙片进入通道的锥形端部部分时,该填隙片形成第一部件的一个其高度被扩张的远端。第一部件的远端从而将其高度扩张到外科医师希望的程度,以便对脊柱融合手术提供所要的“脊柱前凸”量。

同样,第二部件最好由一顶部颚片和一底部颚片形成,两颚片能彼此相对地枢轴式转动,例如围绕一枢轴。在顶部颚片和底部颚片之间通过一个孔,在孔内移动一个楔形件,其移动方式使顶部颚片和底部颚片分开并使第二部件的高度在第二部件的第一远端处增大。

两部件本身的插入以及填隙片和楔形件在两部件中的移动以增大其高度都通过小的后切口来完成。对植入物装置的两部件提供了各种不同的枢轴机构、填隙片和楔形件机构及其它构造变型。

附图简述图1是有一包含本发明的植入物装置的椎间空间的人体脊椎的侧视图。

图2-5是沿图1的线5-5截取的顶视平面图,例示植入本发明植入物装置中涉及的四个基本步骤。

图6是该植入物装置的第一部件的侧视图,其空腔内部细节用虚线表示。

图7是图6中所示的第一部件的顶视平面图。

图8是图6中所示的第一部件的近端立视图。

图9是图6中所示的第一部件的全截面图,图中示出本发明的一根引导线和填隙片进入第一部件中的通道内以扩张第一部件的邻近其远端的高度。

图10是图9中所示的第一部件的在填隙片已全部进入第一部件的通道后的全截面图,第一部件的远端的高度因此已经增大。

图11是本发明的植入物装置的第二部件与用来增大本发明的植入物装置的第二部件的远的第一端的高度的工具的一种形式一起的全截面侧视立面图。

图12是图11中所示的第二部件与用虚线表示的内部细节的顶视平面图。

图13是图12中所示的第二部件的近的第二端的视图。

图14是图11中所示的第二部件在一个楔形件已完全前进以增大第二部件的远的第一端的高度之后的全截面图。

图15是表示可用来植入本发明的第一部件或第二部件的工具的一种形式的夹钳的顶视图。

图16是图6中所示的第一部件的替代实施例的表示一偏置枢轴的侧视立面图。

图17是图16中所示的替代实施例的近端的视图。

图18是本发明的第一部件的第二替代实施例的近端的视图。

图19是本发明的植入物装置的第一部件的第三替代实施例与用虚线表示的内部细节的侧视立面图。

图20是图19中所示的第三替代实施例的远端的视图。

图21是图19中所示的第三替代实施例在与本发明的植入物装置的第三替代的第一部件一起使用的一个替代的填隙片完全前进后的侧视立面图。

图22是本发明的植入物装置的第一部件的第四替代实施例的全截面侧视立面图,表示一根引导线与一个在第四替代的第一部件中前进经过一孔道的填隙片和一近填隙片及扩张枢轴,以使本发明的植入物装置的第四替代的第一部件的近端能够扩张其高度。

图23是图22中所示的第一部件的第四替代实施例在将该实施例的近填隙片插入一个近凹部以增大本发明的植入物装置的第四替代的第一部件的近端高度的全截面侧视立面图。

图24-27是本发明的植入物装置的第四替代的第一部件的一个扩张的枢轴的截面图和侧视立面图,详细表明该扩张的枢轴的操作中的各个阶段。

图28-30是本发明的植入物装置的替代装置的顶视平面图,表示能够如何在第一部件中的孔道和第二部件中的颈部邻近处提供各种斜面和释放切口,以便于第二部件在第一部件的孔道内转动和便于第二部件相对于第一部件的角度不单纯是垂直角度的取向。

实现本发明的最佳方式参照附图,各图中相同标号表示相同部件,标号10(图1)指示一个植入物装置,用于在已经从椎间空间S中移去一个椎间盘之后移植到相邻椎骨V之间的椎间空间S中。第一部件20和第二部件60沿不同的通道被植入,但在椎间空间S内联锁在一起而形成单独的植入物装置10。形成的装置10使邻近椎间空间S的椎骨V牢固地稳定,以便将两块椎骨V脊柱融合在一起。

本质上,特别参照图1-图5,来描述植入物装置的基本细节。植入物装置10包括第一部件20(图2)和第二部件60(图4)。第一部件20为沿第一轴线A延伸的细长形。第一部件20最好高度大于宽度(比较图2和图3),从而有一矩形截面。因此第一部件20能够在其侧面上插入椎间空间中(沿图2的箭头C),而后在椎间空间中转动(沿图3的箭头F),以帮助扩展邻近椎间空间S的两块椎骨V彼此分开。第一部件20还包括从侧面穿过第一部件20的孔道30(图2)。

第二部件60(图4)是细长的,其外形大体上与第一部件20的外形相似。但是,第二部件60包括一个颈部70而不是第一部件20的孔道30。第二部件60的截面尺寸与孔道30相似。该尺寸使第二部件60能够沿第二轴线B(沿图4的箭头E的方向)插入第一部件20的孔道30。第二部件60稍后能够以类似于第一部件20转动的方式转动(沿图5的箭头G),使得第二部件60的高度沿垂直方向,并尽可能增大邻近椎间空间S的两椎骨V的间隔。部件20、60联锁在一起而形成植入物装置10,部件20、60使彼此稳定,并使植入物装置10能够稳定其中植入了装置10的椎间空间。

更具体地说,特别参照图6-图10,来描述按照本发明的一个优选实施例的第一部件的细节。第一部件20是一个由顶部构造22和底部构造24形成的基本上刚性的细长构成物,构造22和24可以枢轴式转动地结合在一起,例如用枢轴25。枢轴25可以取许多不同形状来提供允许顶部构造22和底部构造24能够彼此相对地枢轴式转动的基本功能。

第一部件20从远端26延伸到近端28。能够可以选择地包括一个引导线止动器27与底部构造24一起在远端26处并向上伸出而超过顶部构造22。

孔道30沿侧面在第一部件20的顶面和底面之间穿过第一部件20。孔道30包括一个最好基本上与底部34平行的顶部32和延伸在底部34与顶部32之间的侧面36。孔道30的尺寸最好与第一部件20本身的外部尺寸相似,但转动90度。因此孔道30的尺寸允许具有相似于第一部件20的尺寸的第二部件60在椎间空间S内形成本发明的植入物装置10期间(图1-5)从侧面穿过孔道30。

通道40沿纵向延伸在第一部件20内和顶部构造22和底部构造24之间。通道40在第一部件的近端28处包括一个入口42。通道40还包括一个最好基本上平行于底面46并与底面隔开的顶面44。最好是,通道40从入口42到通道40与孔道30相交的位置具有恒定的截面。通道40最好继续越过孔道30并通向第一部件20的远端26。但是,通道40在孔道30的远侧上的部分最好逐渐变窄而形成通道40的锥形端部48。在通道40内直接邻近孔道30处最好设置一个台阶49。

通道40的形状做成可以在其中容放一个填隙片50。填隙片50(图9)最好具有大体上填充该通道40(图8)的矩形截面,使得该填隙片不会转动。填隙片50最好包括一个高度比尾部54小的顶端52。中心通路56最好穿过填隙片50。引导线58能够完全穿过通道40直到止动器27(沿图9的箭头H),然后填隙片50穿线在引导线58上。然后填隙片50能够容易地沿引导线58前进(图9的箭头J)并引入通道40。当填隙片50到达通道40的锥形端部48时,在一个合适的填隙片推动工具的帮助下,填隙片50使第一部件20的顶部构造22和底部构造24彼此扩张分开(围绕图10的箭头K),而第一部件20的高度在第一部件20的远端26处增大。

第一部件20的这种远端26高度扩张在许多情况下是需要的,以便对椎间空间S提供脊柱前凸。具体地说,脊柱前凸是对锥间空间S的取向,那里锥间空间S的前缘的高度大于其后缘的高度。这样的脊柱前凸能够提供不同的程度,取决于医护人员的愿望。利用本发明,填隙片50前进了所希望的一个量而通过第一部件20的通道40,以提供填隙片的一个在医护人员判断中所希望的量。部件20能够定做而设计成提供所希望的脊柱前凸或能够在植入期间可以可变地扩张以便调节。

特别参照图11-图14,图中描述了第二部件60的优选实施例。第二部件60最好有一个与第一部件20相似的总体外形轮廓。同时,第二部件60最好分成可枢轴式转动地连接在一起的顶部颚片62和底部颚片64,它们可枢轴式转动地连接在一起,例如在枢轴65处。如对第一部件20一样,枢轴65能采取各种不同构型。第二部件60从第一远端66延伸到第二近端68。

第二部件60包括一个颈部70,该颈部70有两个最好基本上平行的表面72和延伸在颈部70的平行表面72与第二部件60的顶面和底面之间的侧壁74。侧壁74可以垂直于平行表面(如图4中大体上描绘的)或可以是斜面(如图11中所示)。平行表面72之间的距离小于第二部件60的顶面和底面之间的距离。平行表面72不需精确平行,但其高度小于第二部件60的顶面和底面的高度是有利的,使得第二部件60的颈部70是一个开口区,然后在将第二部件60转动到使其顶面和底面与第一部件20的顶面和底面垂直对准的取向时能够停留在第一部件的孔道30或其它开口区中(图5)。最好是,颈部70安置在第二部件60的远的第一端66和近的第二端68之间的中点附近。

第二部件60的两侧面之间的宽度最好相似于颈部70的高度和第一部件20中孔道30的高度,以便在转动(围绕图5中箭头G)前和转动后在孔道30中紧配合。第一部件20中的枢轴25、部件20、60的一般稍许的可弯曲性和可能的稍许附加的容隙能够提供允许第二部件60在孔道30内与颈部70一起转动所需的松动。最好是,第二部件60能够卡入其最终位置,使得部件20、60牢固地联锁在一起。

为了对椎间空间S提供脊柱前凸,第二部件60的形状能够扩张高度,特别在远的第一端66处。具体地说,第二部件60包括一个从近的第二端68沿纵向通过的孔80,至少一部分路径向着远的第一端66。孔60内包括一个销82,销82在其最接近第二部件60的远的第一端66的端部处包括一螺纹端83。销82的入口端84与螺纹端83对置并最接近第二部件60的近的第二端部68。能够利用一个具有各种不同构型之一的扳手85(图11)来通过扳手85与销82的入口端84相互作用而转动。最好是,孔80在邻近近端68处稍小,以防销82在孔80内向着近端68滑动。

楔形件86安置在孔80中的锥形孔腔87内。楔形件86最好是圆柱形的,并包括一个通过楔形件的弯的侧面垂直延伸的螺孔,螺孔内安置销82的螺纹端83。因此,当销82由于工具85的转动而转动(沿图11的箭头L)时,销82的螺纹端83使楔形件86向着第二部件60的远的第一端66行进(沿图14的箭头M)。当楔形件86向着远的第一端66行进并通过锥形空腔87时,顶部颚片62和底部颚片64垂直扩展(沿图14的箭头N),增大第二部件60的高度。

虽然图示的第一部件20和第二部件60具有唯一的垂直扩张部件20、60的顶部和底部的系统,但可以注意到,这些系统仅仅是部件20、60的垂直高度增大系统的一个当前最优选的实施例。事实上,可以利用各种不同的系统来增大植入后部件20、60的垂直高度。

最优选的是,部件20、60具有的顶面和底面之间的高度近似地两倍于部件20、60的两侧面之间的宽度。能够利用一把夹钳90(图15)来将部件20、60合适地安置在椎间空间S内(图1)。夹钳90通常具有钳指92,钳指具有尖端93,其宽度近似于部件20的侧面宽度的一半。以此种方式,可以用夹钳90的钳指92的尖端93夹住部件20、60的侧面,而部件20、60能够通过一个套管前进,该套管的直径近似于部件20、60的顶面和底面之间的高度。夹钳90可以包括一枢轴94,在夹钳90的端部处具有与钳指92对置的把手96,以便可以释放地夹住部件20、60。

或者是,部件20、60可以在其近端28、68处通过部件20、60的顶面、底面和两侧面内的适当的接合机构来夹住,以便通过部件20、60的套管不需要因夹钳90或其它安置工具而增大截面直径。

特别参照图16和图17,图中描绘另一种偏置枢轴102的细节。这样一种偏置枢轴102示出在第一替代的第一部件100上。但是,偏置枢轴102同样可以安置在第二部件上,例如第二部件60的一种改型上(图11-图14)。偏置枢轴102有利地允许单独一根轴销穿过其所有枢页(图17)。因此偏置枢轴102不需要通道40(图8)或孔80(图13)的对置两侧上的两个部分轴销。在其它方面,图16和17的替换的第一部件100与本发明的植入物装置10的优选实施例的第一部件20相似。

图18表示第二替换的第一部件110,其特点是一个分叉枢轴112。该第二替换的第一部件110上的分叉枢轴112大致地与优选实施例的第一部件20的枢轴25相似(图8)。但是,叠合的枢页将分叉枢轴112的轴销安置在稍许不同的位置上。图18的第二替换的第一部件110和分叉枢轴112例示许多不同的枢轴构型之一,其中本发明的植入物装置10的部件20、60能够有效地使部件20、60的顶部和底部相对移动。

虽然制造部件20、60的材料通常是某种形式的外科手术级的生物兼容的不锈钢或其它材料,但可以考虑,制造部件20、60的材料可以是碳氢聚合物或其它塑性材料的一种形式,或具有显著的可弯曲特性的金属材料。如果部件20、60用此类材料制成或能够加工成在部件20、60的顶部和底部之间具有足够薄的连接,那么本发明的各种实施例的枢轴25、102、112可以用部件20、60的只是足够地相对弯曲的顶部和底部来代替,以允许部件20、60的远端26、66处的高度产生扩张,从而能够向锥间空间S(图1)提供适当的脊柱前凸量。

特别参照图19-图21,图中描述了第三替换的第一部件。该第三替换的第一部件120的特点是一种与第一替换的第一部件100(图16)的偏置枢轴102相似的偏置枢轴122。第三替换的第一部件120额外包括波浪形的叠合锥形表面124作为其邻近远端的顶部和底部构造部分。这些波浪形的叠合的锥形表面124能够由于第一替换的填隙片126的沿轴向前进而扩展分开像整个部件120一样宽,填隙片126最好是圆柱形的。当第一替换的填隙片126前进时(沿图19的箭头P),它通过能够对锥间空间S(图1)提供的脊柱前凸的不同阶段所对应的一系列阶梯。

因为锥形表面124是波浪形的,所以提供了可以安置第一替换填隙片126的一系列位置。因此能够对锥间空间S(图1)提供对应于各种不同程度的脊柱前凸的不同程度的高度的调整。第一替换的填隙片126可以通过用任何合适形状的推杆穿过入口通道126推动而前进,或者可以利用一个螺纹销前进与优选实施例的楔形件86沿第二部件60的销82前进相似。

因为锥形表面124叠合,所以能够在第三替换的第一部件120的远端处提供更大的高度增大量(见图20)。第三替换的第一部件120的这种高度的变化系统可以以由于外形相当低的通道128而产生的相当直接的方式适合一个具有颈部而非孔道的替换的第二部件,该通道128可以通过一颈部而并不牺牲这样一个替换的第二部件的颈部的强度。因此,该高度变化系统仅为方便而例示于第一部件的上下文中,但可以同样好地包括在第二部件中。

特别参照图22-图27,图中描绘了第四替换的第一部件的细节。第四替换的第一部件130的形状做成既可在其近端也可在其远端进行高度的调整。具体地说,第四替换的第一部件130的顶部和底部最好用膨胀枢轴132结合在一起。

图24-图27中详细地示出膨胀枢轴的功用。膨胀枢轴132包括两个在通过膨胀第四替换的第一部件130延伸的纵向通道对置两侧上的两个独立的轴销134。轴销134安置在槽136中。因此,膨胀枢轴132允许转动和垂直膨胀两者(沿图25和图26中的箭头R)而仍然将第四替换的第一部件130的顶部和底部保持在一起。

穿过第四替换的第一部件的纵向通道包括一个邻近第四替换的第一部件130的近端的近凹部140。近填隙片142能够沿一引导线前进,其方式类似于优选实施例的第一部件20的填隙片50的前进方式。近填隙片142的形状最好与近凹部140的形状匹配。因此,当近填隙片142进入通道时(沿图22的箭头Q),近填隙片142使第四替换的第一部件130的顶部和底部彼此离开,直到近填隙片142安置在近凹部140中。

作为提供近凹部140的替代方法,近填隙片142可以只具有锥形(示于图22),而近填隙片142的锥形表面与第四替换的第一部件130的通路上下表面之间的摩擦可以使近填隙片142留在已前进的位置中,除非对近填隙片142施加了特殊的力。

如图22中所示,一个与优选实施例的填隙片50相似的填隙片首先沿引导线前进而进入第四替换的第一部件130中的通道的锥形端部内。然后近填隙片142前进进入通路。因此,第四替换的第一部件130在邻近其远端和近端两处遇到高度变化。近填隙片142同样能用于与扩展的枢轴132一起装入第二部件60的近的第二端68,以给予第二部件60的近端68高度稳定性。

图28表示第五可替换的第一部件150,该部件独特地包括成斜角的孔道侧面152。这些成斜角的孔道侧面152允许第二可替换的第二部件155以非垂直方向穿过孔道。具体地说,第二部件155相对于第五替换的第一部件150的角度可以是小于90度或大于90度(图28中箭头X)而不必刚巧是90度。图28中示出的角度X为约60度,但可以减小到45度或更小而仍允许第二部件155穿过第五变换的第一部件150而不会被成斜角的孔道侧面152阻塞。成斜角的孔道侧面152与第五替换的第一部件150的长轴成约45度角而不是直角。但是,成斜角的孔道侧面152的角度和第二部件155相对于第五替换的第一部件150的角度X可以增大或减小,取决于医护人员对植入物装置10的要求。

第二替换的第二部件155最好包括一释放斜面156(图28),斜面156使第二替换的第二部件155中的颈部的侧壁能够在第二替换的第二部件155已转入其最终位置后与第一替换的第一部件150的一个侧面接触。释放斜面156从而使第二替换的第二部件155和第五替换的第一部件150能够以完全联锁的方式彼此更完全地稳定,使得植入物装置10按要求完全稳定锥间空间S(图1)。

图29中示出第六替换的第一部件160,包括在部件160的侧面中紧邻孔道的释放切口162。释放切口162是图28实施例的释放斜面156的替换。具体地说,图29例示或者是释放斜面156可以如何设置在第二替换的第二部件155上,或者是释放切口162可以如何设置在第六替换的第一部件160中,使得能够完全转动第三替换的第二部件164而不需要第二替换的第二部件155的释放斜面156。当然也可以采用释放斜面156和释放切口162的组合,使得第一部件和第二部件的紧靠的表面可以以能为整个植入物装置10提供稳定性的方式啮合在一起。

图30中示出与第五替换的第一部件150一起的第四替换的第二部件170。图30中示出的植入物装置具有第一替换的第一部件150的截面图,并清楚例示第四替换的第二部件170能够以不是垂直的角度X(图28)通过第五替换的第一部件150中的孔道而配合,并围绕箭头T旋转而到达最终位置如图28中所示。

从图30可以看出,对于第四替换的第二部件170穿过第五替换的第一部件150中的孔道,并非严格地需要所有斜角孔道侧面152。通过提供沿两个方向的斜角孔道侧面152,第五替换的第一部件150成为可逆的。但是,并非绝对必需包括两个斜角孔道侧面152。相反,在孔道的每一侧面上可以只提供一个斜角孔道侧面152而可以省去其它斜角孔道侧面152。特别是,如图30中所示,可以除去其上包括标号的斜角孔道侧面152而第四替换的第二部件170仍然能够成功地穿过第五替换的第一部件150中的孔道。

在一些颈部侧壁上可以提供类似于释放斜面156(图28)的选择的释放斜面172,但并非所有颈部侧壁上都需要。选择的释放斜面172在围绕箭头T旋转后将停靠第一部件150的相邻侧面并在部件150、170之间提供增强的稳定性。

本公开提供本发明的一个优选实施例和实施本发发明的最佳方式。以此种方式这样描述本发明后,应当清楚,对该优选实施例可以进行各种不同的修改而并不偏离本公开的范围和精神。例如,虽然该实施例中描述的第一部件20和第二部件60是可以扩张的,但本发明的一种简化的变化方案并不需要此种可扩张能力。当各种构造识别为一种完成一功能的机构时,该识别预定包括能完成所列举的功能的所有构造。

商业用途本发明的商业用途是提供一种用于椎间空间的植入物,该植入物能够从后部植入而仍然提供一种基本上刚性的植入物装置,用于扩张和稳定与该椎间空间相邻的椎骨。

本发明的另一目的是提供一种具有外形轮廓尽可能小的独立部件的植入物装置,因而能够以侵害最小的外科手术完成后移植。

本发明的另一目的是提供一种用于椎间空间的植入物装置,该装置最初以独立的部件进入椎间空间,随后联锁在一起。

本发明的另一目的是提供一种椎间空间植入物装置,该装置能调整高度,以使椎间空间的总体积尽可能大,并允许在椎间空间的不同部分内选择的高度的调整,来提供一种具有最大灵活性的尽可能精确地安置邻近该椎间空间的椎骨。

本发明的另一目的是提供一种植入物装置,该装置能够安置在一个椎间空间中而损伤敏感的周围组织的风险很小。

本发明的显示其商业用途的其它目的,在仔细阅读所包括的详细描述、附图和权利要求书后,将非常清楚。

Claims (20)

1.一种用于在椎间空间中进行外科手术安置如脊柱融合手术期间的安置的植入物,该植入物包括以下组合:一个具有在一远端和一近端之间的细长形状的第一部件;一个具有在一第一端和一第二端之间的细长形状的第二部件;以及所述第二部件的在所述第一端和所述第二端之间的一部分与所述第一部件在所述远端和所述近端之间交叉。
2.权利要求1的植入物,其特征在于,所述第一部件和所述第二部件两者的在顶面和底面之间的高度大于所述两部件的两侧面之间的宽度,使得所述两部件围绕一长轴从其中所述顶面沿侧向与所述底面间隔的取向到其中所述顶面在所述底面之上的取向的转动导致所述两部件的高度的增大。
3.权利要求1的植入物,其特征在于,至少所述两部件之一的至少一部分是充分开口的,以允许所述两部件之另一部件至少部分穿过所述开口部分,使得所述两部件至少部分联锁在一起。
4.权利要求3的植入物,其特征在于,所述开口部分足够大,使得所述两部件基本上共平面。
5.权利要求4的植入物,其特征在于,所述第一部件的在一顶面和一底面之间的高度等于所述第二部件的在一顶面和一底面之间的高度,使所述第一部件的所述顶面与所述第二部件的所述顶面共平面,而所述第一部件的所述底面与所述第二部件的所述底面共平面。
6.权利要求3的植入物,其特征在于,所述第一部件在所述远端和所述近端之间是至少部分开口的,而所述第二部件在所述第一端和所述第二端之间是至少部分开口的,所述第一部件中的所述开口邻近所述第二部件中的所述开口,在该处所述第二部件与所述第一部件交叉,使得所述第一部件和所述第二部件至少部分联锁在一起。
7.权利要求6的植入物,其特征在于,所述第一部件的所述开口是一个在顶面和底面之间的孔道,所述孔道至少像所述第二部件的在所述第一端和所述第二端之间的至少一部分那样大,使得所述第二部件能够被配置成穿过所述孔道而延伸。
8.权利要求7的植入物,其特征在于,所述第二部件包括一个在所述第一端和所述第二端之间的颈部,所述颈部在所述第二部件的顶面和底面之间的高度小于邻近所述颈部的所述第二部件的其它部件的高度,所述颈部的高度小于所述第一部件中所述孔道的高度,使得所述第二部件的所述颈部能够被配置成穿过所述第一部件的所述孔道而延伸。
9.权利要求1的植入物,其特征在于,所述第一部件包括一顶部构造和一底部构造,所述顶部构造和底部构造可相对移动,使得所述第一部件的高度可以变化。
10.权利要求9的植入物,其特征在于,所述第一部件包括一个在所述顶部构造和所述底部构造之间的间隔物,所述间隔物使所述顶部构造移动而离开所述底部构造,从而增大所述第一部件的高度。
11.权利要求10的植入物,其特征在于,所述间隔物是一个其顶端高度小于尾部高度的填隙片,所述第一部件包括一个至少部分延伸通过在所述顶部构造和所述底部构造之间的所述第一部件的通道,所述通道在一锥形区内有一较小的高度,所述锥形区比所述近端更接近所述远端,所述填隙片在所述锥形区处的高度大于所述通道的高度,使得当所述填隙片移动通过所述通道而进入所述锥形区时离开所述底部构造。
12.权利要求9的植入物,其特征在于,所述顶部构造和所述底部构造在所述第一部件上的一个位置处枢轴式地连接在一起,该位置比所述远端更接近所述近端。
13.权利要求12的植入物,其特征在于,所述第二部件包括一顶部颚片和一底部颚片,所述顶部颚片可相对于所述底部颚片而移动,所述顶部颚片和所述底部颚片在一位置处枢轴式地连接在一起,该位置比所述第二部件的所述第一端更接近所述第二部件的所述第二端。
14.权利要求13的植入物,其特征在于,所述第一部件中的所述枢轴和所述第二部件中的所述枢轴每个都是扩张枢轴,它们允许邻近所述枢轴的所述构造的部分进行枢轴摆动和垂直移动两种运动。
15.一种用于椎间空间的植入物,该植入物包括以下组合:一个具有在一远端和一近端之间的细长形状的第一部件;一个具有在一第一端和一第二端之间的细长形状的第二部件;所述第二部件的在所述第一端和所述第二端之间的一个部分与在所述远端和所述近端之间的所述第一部件相交;所述第一部件包括一个在所述远端和所述近端之间从侧面通过其间的孔道;所述孔道的高度小于所述第一部件的高度;所述第二部件包括一个在其所述第一端和所述第二端之间的颈部;所述顶部的高度小于所述第二部件的邻近所述颈部的那些部分;以及所述颈部的高度至少像所述第一部件中所述孔道的高度一样小,使得所述第二部件中的所述颈部能够配置成通过所述第一部件中所述孔道而延伸。
16.权利要求15的植入物,其特征在于,所述第二部件的所述颈部的尺寸允许当所述颈部在所述第一部件的所述孔道内时所述第二部件能够围绕其长轴转动至少90度。
17.权利要求16的植入物,其特征在于,所述第一部件包括一顶部构造和一底部构造,所述顶部构造在一比所述远端更接近所述近端的位置处枢轴式连接在所述底部构造上,而所述第二部件具有一个在其一比所述第一端更接近所述第二端的位置处枢轴式连接在一个底部颚片上的顶部颚片。
18.一种椎间空间植入物,包括以下组合:一个具有在一远端和一近端之间的细长形状的第一部件;一个具有在一第一端和一第二端之间的细长形状的第二部件;以及至少所述部件之一在其两端之间的一个位置上至少部分地开口,使得所述第一部件和所述第二部件在其交叉处至少部分地联锁。
19.权利要求18的植入物,其特征在于,所述第一部件和所述第二部件在其两端间包括一个至少部分开口的区域。
20.权利要求18的植入物,其特征在于,所述第一部件包括一个在所述远端和所述近端之间从侧向穿过其间的孔道,所述第二部件包括一个在所述第一端和所述第二端之间的颈部,所述第二部件中的所述颈部的尺寸小到足以穿过所述第一部件中的所述孔道。
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US6368351B1 (en) 2002-04-09 grant
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US8097035B2 (en) 2012-01-17 grant
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JP2004525702A (ja) 2004-08-26 application
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