CN101203194B - 包括自切入固定突出物的椎骨间假体 - Google Patents
包括自切入固定突出物的椎骨间假体 Download PDFInfo
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Abstract
椎骨间假体,特别用于颈椎脊柱,带有两个以关节方式连接的附着板。该附着板的附着面设计用来附在相邻的椎体上,具有基面(3),准备用来支撑在该椎体的表面上;和从所述基面(3)升起的自切入固定突出。按照本发明,这些固定突出物是通过至少一对朝相反方向对预定的植入方向(2)倾斜伸展的肋条(4)形成的,其取向更多远离该植入方向的侧面(5)比其取向更多在植入方向的侧面(6)更陡。该肋条可以装齿。
Description
背景技术
椎骨间假体需要固定到相邻的椎体上,以保证它们不会从预想的位置移开。已知它们装有肋条或栓钉,它们装入椎体的覆盖板中相应成型的固定凹穴内(WO 01/0189301893,WO 2004/080355,DE-3023353,FR-A-2659226)。为了使之产生,要求对椎体覆盖板的深度工作,这在手术期间要求相当高的费用。椎体覆盖板这样的工作也是不希望有的,而且在颈椎脊柱的区域往往是不可能,因为它要求相当大的内脱位,而且以该椎体有相当厚度为先决条件。特别是对于颈椎脊柱,假体结构因此优选不需要在该椎体的覆盖板内形成固定凹穴。这些假体结构包括这样的假体,其中该附着板的外面具有横向延伸的齿状安排,或多或少地覆盖整个表面,并带有锯齿形断面,其陡峭的侧面安排在腹面上(WO 2004/089259,FR-A-2718635)。尽管腹部方向上的假体的位移一般可以用这样的装置防止,然而,因为不一般的解剖或不适宜外科准备,椎骨间空间在腹部方向上有时打开成这样一个明显的楔子形,以至该假体无法可靠地仅仅通过装齿固定就位。这是因为,齿不能穿透骨表面。为了不广泛地损伤皮质骨,从而使之弱化,本来就不打算这样做。反之,准备固定在骨表面,这在正常情况下对保证固定是适当的,因为这时它本身还固定在表面不规则上。在(EP-A-1057462,EP-A-1103237)中还已知带有自切入固定突出物的椎骨间假体。假体附着板的外面形成一个连接到该椎体的附着面。它包括计划固定在骨表面的基面和从基面升起而且这样尖锐的固定突出,以致在关节的自然负载下,并借助于韧带的力和所传递的重量,椎体的内脱位一取消,它们就穿进骨表面。但是,这种类型的已知假体要求相当大的内脱位来保证装配就位时它们不被固定突出妨碍。在某些情况下在腰脊柱和胸脊柱的区域这还可以容忍,但是在颈椎脊柱区域则不行。若它们在没有足够的内脱位的情况下被压入,该固定突出物便会在椎体覆盖板中刻出沟道,然后它们会再一次通过这些沟道滑出,除此以外这些沟道也是不希望有的,因为会损失它们要求的强度。后者还适用于在植入方向上伸展的其他已知假体的肋条(WO 2005/007040的图5至8),若它们被中断,而且在该中断区域形式陡峭地落入腹部方向的端面。最后,已知一种假体(US2004/0002761A,图26A和26B),其边沿上的附着面具有一系列径向的固定突出物,其中每一个都在等边三角形的底边上向半径方向伸展,具有在两侧对称地散开的侧腹。两个固定突出物在每一侧上都朝相反方向对该介质平面倾斜伸展。因为它们指向植入方向的侧面并不比它们指向远离植入方向的侧面更不陡峭,它们具有上述缺点,它们不是要求椎骨间空间有相当大的内脱位才能植入,就是若不如此,就会在骨的表面刻出沟道,它们会通过这些沟道再次滑出。
发明内容
因此,针对这些问题,本发明提供一种带有自切入固定突出物的椎骨间假体,即使只使该椎体略微内脱位,它便可以被引入可靠的固定位置,而又不过度损伤处于它们的固定位置的在腹部方向上的区域的椎体的覆盖板。
从刚才提到的先有技术出发,按照本发明解决方案在于:一种椎骨间假体,用于颈椎,带有两个附着板,它们以关节方式连接,而且其设计用来附在相邻的椎体上的附着面具有一个基面,用于支撑在该椎体的表面上;和从所述基面升起的自切入固定突出物,固定突出物由至少一对肋条形成,这些肋条在相反方向上相对于预定的植入方向倾斜地伸展,其中更多地远离植入方向取向的肋条的侧面比更多地于沿着植入方向取向的滑止面更陡。相应地,该固定突出物通过至少一对朝相反方向对植入方向倾斜延伸的肋条形成。植入方向一般是AP方向(AP=前后)。该肋条宜以中间平面(中央前后向的平面)为轴对称安排。它们倾斜安排的结果是,这些肋条有一个侧面的取向更多地远离植入方向,而另一个侧面的取向较少远离该植入方向。其取向较多地远离该植入方向的侧面,一般在腹部方向上是陡峭的,而且优选大致垂直于该基面,以便对假体的向前运动产生相当大的阻力,并用该装置将其固定在椎骨间空间。其取向较少远离植入方向的另一侧面一般是温和地倾斜的,以便在该假体插入的过程中减少阻力,并保护这些肋条滑过的骨表面。依靠它的较小的倾角,它形成一个滑止面。
若在植入过程中该肋条的前导面陡峭和尖锐就会被刨掉的骨表面上的任何不规则,可以滑过这个表面滑到肋条上,而又不受损伤或只受最小的损伤。在与植入方向平行的方向上延伸的平面上测量,它应该围成一个对该基面小于45°的角度。这里假定该基面大致上与该附着板的主方向平行延伸。为了提供很小的阻力并为了尽可能把该骨表面的损伤减到最小,该滑止面可以是平滑的。但是,一个实施例也是有利的,即把滑止面粗糙化,例如,设置小齿,它们在植入之后,与骨表面紧密连接,以便获得额外的固定作用。
该肋条可以具有一个基本上均匀的恒定的轮廓。该轮廓应该尖锐得足以保证该肋条可以在该关节的负载下,在内脱位取消之后,穿进该骨表面。于是,该滑止面由它的更多地向着背部的侧面形成。
优选一个实施例,其中该肋条多次中断,以便形式一系列尖顶的或尖锐的齿。这减少了该肋条剖面表面积的大小(一个与该假体表面范围平行延伸的截面),它确定穿进骨表面的阻力。因此,该由齿形成的肋条比起类似轮廓的连续肋条更容易穿透骨表面,而且穿透更深。按照本发明另一个特徵,该中断在该AP方向的横向伸展,它们形成对抗该假体在腹部方向上的运动的额外的表面。因此,这些表面也应该是陡峭的。若该中断在所有肋条中平行伸展,则它们更容易产生。
在该实施例中,形成这些肋条的齿有四个限定面。第一限定面是通过对该前后方向倾斜延伸的肋条的更多地向着腹部的侧面形成的。第二限定面是该肋条第一相反侧面的表面,一般与第一限定面平行延伸,并更多地向着植入方向。第三和第四限定面是通过这些齿之间的中断形成的。第三面取向远离植入方向并且是陡峭的。第四面向着植入方向,而且较不陡峭。第三和第四面赋予这些齿一个锯齿形断面。第二面和第四面都起滑止面的作用。起滑止面作用的第二面对该假体的平面也可以是倾斜的,但对于滑动阻力第四面在大部分情况下更重要。
在本发明的另一实施形式中,该中断与植入方向平行伸展。以此减少在植入过程中对该骨表面有刮削作用的边沿的尺寸。在这种情况下,只有对植入方向倾斜延伸的肋条侧面,才形成对该假体在腹部方向上的运动阻力,并在背向面形成滑止面。
在目前的上下文中陡峭一词表明与基面所呈的角度几乎为90°。该角宜大于70°,这个角度不是在一个垂直于测量侧面的平面内并对该基面测量的,就是在一个前后向平面内测量的。它可以超过90°(侧凹)。
该肋条的自切入特性主要用它们平行于该基面的断面积描述。为了保证关节力足以把这些肋条压入骨表面,它们只占总附着面积的一个小部分。它们充分地嵌入骨内时,在附着面上所占的表面积比例,这是该附着面上它们的总表面部分(占的比例),不应该大于五分之一,优选不大于十分之一。因为它们不必在手术之后立即完全压入骨内,它们在中间高度上与基面平行的剖面积宜不大于该附着面积的十分之一,优选不大于二十分之一。它们应该是尖锐或尖顶的,以保证即使在关节力异常小的情况下,它们在手术之后也立即略微压入骨内。尖锐或尖顶一词是说边沿角度或尖顶角度不大于50°,在尖顶在不同的尖顶平面上具有不同的尖顶角度的情况下,最小尖顶角度是关键。
椎体的尾板对肋条或形成后者的这些齿压入提供阻力,所述阻力越大,尾板越致密。因为该中央区域的密度小于外区域,该肋条应该主要安排在该附着面的内区域。更精确地说,它们占表面积的至少一半,从其最近的边界起,它们应该处于该附着面AP尺寸6分之一以上的距离处。具体地说,该附着面背侧区域应该没有肋条,使得该基面可以把力转移到紧凑的,未受损的骨物质上。
肋条优选安排成V-形,带有一个向前面开口的空间。至少一个肋条对的肋条在背部方向彼此接近。相反的配置也行。但是,肋条在它们之间,在它们的腹向面上,包围一个骨物质连续块,并防止它在腹部方向上移动,这已经证明是适宜的。可以把几个平行肋条安排在该对称轴线上的每一侧。但是,一般,每侧有一个肋条就够。
肋条在该基面以上的高度应该足以牢固地啮合在该骨物质上。一般应该不小于0.5毫米。它们的高度受在植入过程中把内脱位减到最小的目的的限制,而且受该椎体的覆盖板背固定突出物的刮削作用限制。一般应该不超过2毫米(优选1.6毫米)或该附着面AP尺寸的8分之一(优选10分之一)。对于颈椎假体,0.7到1.5毫米的高度已经证明是有用的。该高度是在该基面以上测量的,亦即,在包围这些希望支撑在该骨上的肋条的表面上测量。若该表面具有粗糙度,例如,多孔涂层或安排几行齿,基本上覆盖整个表面积,而骨物质计划随着时间流逝逐渐生长入这些齿之间的间隙,粗糙的表面积是一个关键性因素。
这些肋条与植入方向所夹的角度不一定要大。由更多地向着腹部的肋条侧面形成的角度优选小于60°,小于30°更好。约10和20°之间的角度已经证明是特别适宜的。
特别是若该椎骨间空间在腹部方向上以明显的楔形向外打开,则会危害该假体的永久性安装。因为在这种情况下,假体的附着板和椎体的尾板之间的连接在背部区域比腹部区域更可靠,本发明建议,这些肋条在附着面的背部区域至少也是有效的。为此目的,至少一对肋条在背部边界上应该至少达到该附着面AP尺寸的5分之一,优选至少达到AP尺寸的10分之一。
附图说明
下面参照描述有利的示例性实施例的附图更详细地说明本发明,附图中:
图1表示附着板的平面视图;
图2表示沿着图1的II-II线的剖面图;
图3表示沿着图1的III-III线的剖面图;
图4表示第二实施例的平面视图;
图5表示按图4中箭头V看去的视图;
图6表示修改后的实施例的同一视图;
图7表示沿着图4的VII-VII线的剖面图;而
图8和9表示其它肋条安排的平面视图。
具体实施方式
图1表示以中间平面1为轴对称的假体附着板附着面的视图。它对椎骨间空间形状的适应意味着它具有一个预定的腹向面和背向面。植入方向也是预定的,在所示的示例中,是从腹部到背部的方向2。
该附着面包括一个基面3,它准备用来尽可能跨越整个表面积支承在骨上,并可以设有一个允许借助于在孔或其它凹穴中生长的骨组织紧密连接的表面结构。该基面包围两根肋条4,后者以中间平面1为轴对称地安排并围成一个大约20°的α角。它们的更多地向着腹部的侧面5陡峭,就是说,对基面3大约呈90°,而更多地向着背部的与此平行走向的侧面6在一个与该肋条垂直延伸的断面(图2)上对基面3大约呈45°角度倾斜。在与该植入方向平行延伸的截面(图3)上,角度显得平缓得多。但是,它安排得在植入运动过程中逐渐滑到分配给它的椎体覆盖板的骨表面或软骨表面上。这甚至在所涉及的椎体尚未首次内脱位到一个大于该假体厚度的间隔时都是适用的。正因为如此,它被标示为滑止面(Aufgleitflche)。因为这两个侧面5和6彼此夹成一个大约45°(或者甚至更小)的角度,它们在该肋条的头部形式一个尖锐切割刃7。当连接该椎体的韧带的力和脊柱要承受的负荷在植入之后使有关的椎体彼此相向移动时,该肋条完全或部分地穿进骨组织并把该假体锚固在要求的位置上。对它来说,不必在手术之后立即使它的整个高度陷入骨头;但是,人们力求保证,手术之后短时间内,使基面3支撑在骨表面一个大的区域上。这一方面是通过该肋条的尖锐达到的,而另一方面,是通过它在附着面总表面积中占的小的表面积比例达到的。这表面积比例在该肋条头部最小并逐渐增大,直到它的中间高度,达到大约该附着面尺寸的5%。预期手术之后不久,该肋条至少大约陷入骨中这个深度。在其足部测量,它的表面积比例大约两倍大。
肋条3的固定作用是基于它们的与包括在它们之间的骨物质的相互作用。只有它的更多地向着腹部的侧面5要压缩它们本身之间的骨物质时,该假体才可能从该椎骨间空间逸出。它对这个变形提供这样强大的阻力,以致该植入体足够牢固地用这个装置固定在它的位置上。这在手术之后立即起作用,因为该滑止面6的倾斜形状具有在植入过程中使腹向面或没有磨掉和刮掉的内面紧接在每一个肋条骨物质或软骨物质被肋条4,或者已经是这样,只是范围小,因此,仍旧可以用来固定该假体。
在按照图4的实施例中,被侧面15,16限定的肋条14横向装齿。齿17是锯齿形的带有一个陡峭的腹向面18和一个作为滑止面的温和倾斜的背向面19。该齿的轮廓宜以90°向中间平面1延伸,使得所有肋条的齿都可以通过均匀的平刨产生。但若这方面并非关键问题,则它们可以选择具有一个不同的方向。
例如,可以使用一个与植入方向2平行地延伸的轮廓,其中(在植入方向上看)这些齿之间存在间隙。这具有使植入阻力大大地减少的优点。确实,该轮廓无法避免这些齿在植入过程中在某种程度上刮在骨表面上,但是,它们不会驱使刮离物和发生了位移的物质推倒它们的前面,反而让它们留在这些齿的间隙里。当这些齿到达它们最后的位置时,这些物质不是位于它们的后面,而在会在最近的腹侧。因此,能够促进这些齿在手术后的锚固。
在按照图4的实施例中,肋条轮廓(在该肋条的纵向看)还可以配置得如图2所示,亦即,在侧面16上缓和地倾斜下来。于是,肋条14的滑止面不仅通过每一个单个齿17的背向面19形成,而且通过肋条14的侧面16形成。但是,还可以选择图7所示的肋条轮廓,其中侧面16就和侧面15一样陡峭。在这种情况下,这些齿17的背向面19单独形成滑止面。还可能选择中间阶段,其中侧面16以一个相对陡峭的角度倾斜,但在按照图3的截面上给出一个平缓得多的滑止角,这对植入程序很关键。
当这些齿17的背向面19是平滑的(图5)时,它在植入过程中在保护骨表面方面起有利的作用。但是,为了在植入之后提供一个额外的锚固可能性,粗糙对它也可以是有利的。该变型示于图6,它表示表面19′装细齿。
重要的是,植入体很好地锚固在椎骨间空间的背部区域,因为,若就在植入之后,当附着板尚未与骨表面结合时,脊柱的强脊柱前突屈刚好发生,则附着板在腹部区域有可能从该椎体表面提起。因此,把肋条4,14大约引导到附着面的背向沿是适宜的。另一方面,可能希望使用椎体尾板的边沿区域把负荷力从骨传到假体,因为假体较大的密度意味着它们非常适宜于承受力。若该肋条,至少它们所占表面积的一半处于该附着面从其边界AP尺寸的六分之一以上,则本发明满足这两个目的。该AP尺寸是前后方向的尺寸。
按照本发明的安排不一定限于一对肋条。反之,正如在图8和9中举例说明的,可以存在几对。在所示的示例中,它们安排得使它们围成一个V-形空间,在腹部方向上向外开口。该空间还可以在背部方向敞开,但是,正如在按照图9的实施例的情况下,处于两个中央肋条之间。
Claims (22)
1.椎骨间假体,用于颈椎,带有两个附着板,它们以关节方式连接,而且其设计用来附在相邻的椎体上的附着面具有一个基面(3),用于支撑在该椎体的表面上;和从所述基面(3)升起的自切入固定突出物,固定突出物由至少一对肋条(4,14)形成,这些肋条在相反方向上相对于预定的植入方向(2)倾斜地伸展,其特征在于,更多地远离植入方向取向的肋条的侧面(15)比更多地于沿着植入方向取向的滑止面(6,16)更陡。
2.权利要求1所述的假体,其特征在于,该植入方向(2)是从前向后方向。
3.权利要求2所述的假体,其特征在于,该固定突出物(4,14)相对于中间平面(1)对称地布置。
4.权利要求1所述的假体,其特征在于,更多地向着腹部取向的侧面(5,15)垂直于该基面(3)。
5.权利要求1至4之一的假体,其特征在于,在与该植入方向平行并垂直于基面(3)延伸的平面上测量,该滑止面(6,16)与该基面(3)夹成一个小于45°的角度。
6.权利要求1至4之一的假体,其特征在于,该肋条(4)具有均匀和恒定的轮廓,并且它的滑止面是通过它的更多地向着背部取向的侧面(6)形成的。
7.权利要求1至4之一的假体,其特征在于,该肋条(14)多次中断,以便形成一系列尖顶的或尖锐的齿(17)。
8.权利要求7所述的假体,其特征在于,该中断在一个与该基面平行地延伸的垂直于植入方向(2)的截面中伸展。
9.权利要求8所述的假体,其特征在于,这些齿(17)具有陡峭的腹向侧面(18)和较不陡峭的背向侧面(19,19′)。
10.权利要求9所述的假体,其特征在于,这些齿(17)具有锯齿形轮廓,而其较不陡峭的背向侧面(19,19′)形成滑止面。
11.权利要求7所述的假体,其特征在于,该中断在与该基面平行延伸的并与该植入方向(2)平行的截面中伸展。
12.权利要求1至4之一的假体,其特征在于,该肋条(4,14)所占表面积的比例不大于该附着面的五分之一。
13.权利要求12所述的假体,其特征在于,该肋条(4,14)的横截面面积在一个位于该基面(3)上方一半高度上延伸的截面中不大于该附着面的十分之一。
14.权利要求1至4之一的假体,其特征在于,该肋条(4,14)所占的表面积的至少一半处于与该附着面的边界相距大于该附着面的从前向后尺寸的六分之一的距离。
15.权利要求1至4之一的假体,其特征在于,该肋条(4,14)中至少一对肋条在背部方向上彼此接近。
16.权利要求15所述的假体,其特征在于,几个肋条在对称平面(1)的每一侧安排得彼此平行。
17.权利要求1至4之一的假体,其特征在于,肋条(4,14)在该基面以上的高度不大于该附着面从前向后尺寸的十分之一。
18.权利要求1至4之一的假体,其特征在于,在一个与该基面平行延伸的截面上该肋条(4,14)的更多地向着腹部取向的侧面(5,15)所围成的角度(α)小于60°。
19.权利要求18所述的假体,其特征在于,该角度(α)处于5和15°之间。
20.权利要求1至4之一的假体,其特征在于,该滑止面(19′)粗糙化或加工有齿。
21.权利要求1至4之一的假体,其特征在于,至少一对肋条达到该附着面到其背部边界的从前向后尺寸的至少五分之一。
22.权利要求18的假体,其特征在于,在一个与该基面平行延伸的截面上该肋条(4,14)的更多地向着腹部取向的侧面(5,15)所围成的角度(α)小于30°。
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2006
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- 2006-06-20 KR KR1020087001577A patent/KR101356241B1/ko active IP Right Grant
- 2006-06-20 WO PCT/EP2006/005910 patent/WO2006136373A1/de active Application Filing
- 2006-06-20 CA CA002598018A patent/CA2598018A1/en not_active Abandoned
- 2006-06-20 CN CN2006800224735A patent/CN101203194B/zh active Active
- 2006-06-20 AU AU2006261207A patent/AU2006261207B2/en not_active Ceased
- 2006-06-22 US US11/472,543 patent/US20070010888A1/en not_active Abandoned
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2010
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AU2006261207A2 (en) | 2006-12-28 |
AR056386A1 (es) | 2007-10-10 |
US20100191334A1 (en) | 2010-07-29 |
AU2006261207A1 (en) | 2006-12-28 |
NO20080421L (no) | 2008-01-22 |
EP1736120A1 (de) | 2006-12-27 |
US20070010888A1 (en) | 2007-01-11 |
CA2598018A1 (en) | 2006-12-28 |
US8721725B2 (en) | 2014-05-13 |
CN101203194A (zh) | 2008-06-18 |
AU2006261207B2 (en) | 2012-04-12 |
KR101356241B1 (ko) | 2014-01-28 |
WO2006136373A1 (de) | 2006-12-28 |
US20140336767A1 (en) | 2014-11-13 |
KR20080035574A (ko) | 2008-04-23 |
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