CN101442947A - 用于骨固定系统、使用固定螺钉元件和可变形鞍状元件的锁定设备和方法 - Google Patents

用于骨固定系统、使用固定螺钉元件和可变形鞍状元件的锁定设备和方法 Download PDF

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CN101442947A
CN101442947A CNA2007800173795A CN200780017379A CN101442947A CN 101442947 A CN101442947 A CN 101442947A CN A2007800173795 A CNA2007800173795 A CN A2007800173795A CN 200780017379 A CN200780017379 A CN 200780017379A CN 101442947 A CN101442947 A CN 101442947A
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coupling device
retaining element
set screw
locking device
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J·D·摩尔
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Warsaw Orthopedic Inc
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    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
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Abstract

一种固定螺钉,带有可变形的鞍状物,用于将固定元件稳定在骨固定系统中。骨固定系统包括骨锚、固定元件、耦合装置和锁定设备。锁定设备被构造,以便啮合耦合装置;耦合装置被构造,以便将固定元件啮合到骨锚上。被构造通过螺纹方式进入到耦合装置中的所述锁定设备包括固定螺钉,其连接在鞍状元件上。鞍状元件是用可变形材料制造的。锁定设备被构造,以便摩擦地将固定元件稳定在耦合装置之内,这是通过应用压力实现的。

Description

用于骨固定系统、使用固定螺钉元件和可变形鞍状元件的锁定设备和方法
技术领域
本发明总的来说涉及整形外科移植,用于脊柱损伤或畸形,更特别地,但不是排他地,涉及用于固定脊柱的特别片段或水平的仪器,允许畸形纠正或其愈合。
背景技术
在脊柱手术领域,已知将移植物放置到椎骨中的原因有许多,包括:(a)纠正脊柱的异常弯曲;(b)维持适当的脊椎间隙,且为断裂或其它损伤的椎骨提供支持;和(c)要在脊柱中进行其它治疗。
典型的脊柱移植或骨固定系统使用杆作为支持和固定元件。在这样的系统中,一系列的两个或多个骨紧固件被插入到将被仪器操作的两个或多个椎骨中。然后将杆或其它固定设备放置在骨紧固件的头部中,或者附着在骨紧固件的头部,或者被放置在连接所述杆和所述骨紧固件头部的联接设备中。然后固定下来这些多个部件之间的连接,从而在脊柱中以多个程度固定支持构件。
为了改进骨移植的状况,相信对于这些骨固定系统的改进是渴望的,并在此文中涉及。
发明内容
将固定元件、骨紧固件和联接设备在骨固定系统中连接在一起会导致施加到固定元件上的力量更大,从而增加术后失败发生的可能。因此,存在使用可变形材料在骨固定系统中稳定固定元件的需求。在固定元件和联接设备锁定介面上引入可变形材料将降低固定元件中实现的压力,降低固定元件上表面压力升高的产生,且增强骨固定系统中的保护水平。
当前,许多使用于骨固定系统中的骨紧固件潜在地导致部件失败,失败发生在体内术后加载中,这是由于放置在部件上的压力水平的增加,而这是因为某些移植设计和特定构建材料。当前,使用碳纤维复合材料聚合物和其它材料正在发展中,所述碳纤维复合材料聚合物和其它材料在固定元件的制造中有类似挠曲模量。当锁定元件的固定元件和部件是用类似或相同材料制造时,这样可实现的一个优点是降低或消除了应力集中的区域。此处描述的本发明解决了使用不类似构建材料的相关问题,是通过在锁定装置的构成中使用可变形材料解决的。制作锁定设备和稳定元件中使用这样的材料可降低压力升高的产生,从而导致所稳定的固定元件中实现的压力水平的降低。
因此,现有技术的缺点被克服,并且提供了其它优点,即提供了在骨固定系统中使用的锁定设备,所述骨固定系统包括骨锚、耦合装置和稳定元件,其中耦合装置被构造,将稳定元件耦合到骨锚上,锁定设备包括一个固定螺钉元件和一个鞍状元件。固定螺钉元件被构造,可操作性地与耦合装置啮合,将固定元件稳定在耦合装置中。鞍状元件是用可变形材料制造的,被附着在固定螺钉元件上。鞍状元件包括一个远端介面表面和一个近端介面表面,远端介面表面的外形被构造,部分地围绕着固定元件,这种情况在固定元件被放置在耦合装置中时发生。鞍状元件的近端介面表面被构造,耦合到固定螺钉元件上。
本发明提供了,在其它方面,一种骨固定系统,所述骨固定系统包括骨锚、耦合装置和锁定设备。耦合装置被构造,可操作性地连接到骨锚和固定元件上。锁定设备包括一个固定螺钉元件和一个鞍状元件,其中固定螺钉被构造以螺纹方式进入到耦合装置中。鞍状元件附着在固定螺钉元件上,且是用可变形材料制造的。
锁定设备使用在应用了固定螺钉元件和可变形鞍状元件的骨固定系统中的改进方面是,鞍状元件是使用与固定元件相同的材料制造的。用于产生鞍状元件和固定元件的材料是塑料类型。用于制造鞍状元件和固定元件的塑料是可变形的,其挠曲模量彼此或者相同,或者基本上类似。优选用于制造鞍状元件和固定元件的塑料是聚醚醚酮。使用聚醚醚酮的潜在缺点是材料易于断裂,这是由于其内在的缺口灵敏度。
本发明提供了,在另一个方面,一种固定脊柱的方法,所述方法使用了骨固定系统。所述骨固定系统包括骨锚、固定元件、耦合装置和锁定设备,其中耦合装置被构造,将固定元件耦合到骨锚上,锁定设备可操作性地与耦合装置相关。锁定设备包括固定螺钉元件,其被构造啮合耦合装置,和一个鞍状元件,其被耦合到固定螺钉元件上,其中鞍状元件是用可变形材料产生的。该方法进一步包括将固定元件定位在耦合装置中,将锁定设备啮合到耦合装置中,是通过将固定螺钉元件以螺纹方式进入到耦合装置中完成的。固定螺钉元件进入到耦合装置中,导致安装元件部分地紧压固定元件,将固定元件摩擦着容纳在耦合装置中。
进一步,通过本发明的技术实现了其它特点和优点。本发明的其它实施方案和方面在下面进行了详细描述,被认为是本发明的一部分。
附图说明
尤其指出了被认为是本发明的主题,该主题在说明书结束时的权利要求中被明显主张。本发明的前面和其它方面、特点和优点通过下面详细说明以及附图将是显而易见的,其中:
图1是骨固定系统的一个实施方案的透视图,这是根据本发明的一个方面;
图2是耦合装置的一个实施方案的透视图,这是根据本发明的一个方面;
图3是图2的耦合装置的横截面立视图,是沿着线3-3切割的,这是根据本发明的一个方面;
图4是锁定设备的一个实施方案的透视图,所述锁定设备通过螺纹方式啮合到图2和3的耦合装置中,这是根据本发明的一个方面;
图5是图4的锁定设备和耦合装置的侧视图,这是根据本发明的一个方面;
图6是图4和5的锁定设备实施方案的侧视图,这是根据本发明的一个方面;
图7是图4-6的锁定设备实施方案的远端透视图,这是根据本发明的一个方面;
图8是固定螺钉元件的一个实施方案的远端透视图,这是根据本发明的一个方面;
图9是鞍状元件的一个实施方案的远端透视图,这是根据本发明的一个方面;
图10是图9的安装元件的侧视图,这是根据本发明的一个方面;
图11是骨锚的一个实施方案的侧视图,这是根据本发明的一个方面;和
图12是图6的锁定设备的横截面立视图,是沿着线12-12切割的,这是根据本发明的一个方面。
具体实施方式
正如图1中描述的,骨固定系统60的一般配置,根据本发明的一个方面,包括耦合装置10、锁定设备,所述锁定设备包括一个固定螺钉元件20和鞍状元件50,固定元件30和骨锚40。当在脊柱中使用,用于稳定脊柱的多个程度时,骨锚40被放置在个体椎骨中,然后耦合装置10附着在每个移植的骨紧固件40上。在放置多个骨锚和耦合装置后,适当尺寸的固定元件30,其横跨受影响椎骨区域的水平,被放置在耦合装置10中,稳定在使用了多个锁定设备的位置。正如提出的,锁定设备包括固定螺钉元件20和鞍状元件50。当锁定设备使用时,固定元件30被摩擦地保持在耦合装置10和锁定设备之间,是通过鞍状元件50来保持的。锁定设备,具有可变形的鞍状元件50,正如下面描述的,降低了固定元件50中实现的综合压力,这是通过降低表面压力升高的产生实现的,这发生在固定元件被固定在耦合装置10中时,所述耦合装置10是用与固定元件50相同或类似的材料制造的,且有一个凹的远端介面表面,该表面被进一步变形为固定元件50的形状。
关于图2和3,骨固定系统60包括耦合装置10,有一个通道14,该通道是由座13和一对耦合臂11定义出的。耦合臂11被平行放置,以向上方式从座13中突出来。耦合臂11,与座13一起,形成U型通道14,通道14被适当地设计大小,以接受固定元件30。耦合臂11的内壁包括内螺纹12,或可选地内凸轮面(没有给出),以啮合固定螺钉元件20的外螺纹21(正如图4-8所示)。典型地,至少一个通过孔15被直接放置在耦合装置10中的座13之下。在一个方法中,骨锚40(参见图1)被插入到孔15中,这在放置到固定元件30之前进行。骨锚40的纵轴可处于与耦合装置10相对的固定角度,这是在插入到孔15中,或者将被允许在孔15中枢轴转动。孔15可以是平底扩孔的,埋头钻孔的,有一个球形座,被锁上,或这些制造技术的任何组合或衍生,以允许锚头部41的顶部(参见图11)位于座地板16之下。
如图4和5所示,耦合装置10被描述为包括至少一个固定螺钉元件20,其通过螺纹方式与内螺纹12啮合,尽管本技术领域的普通技术人员应该理解到,其它结构也可考虑,包括固定螺钉,其被构造包括一个外凸轮面(没有给出),该外凸轮面与内凸轮面(没有给出)啮合,内凸轮面位于耦合臂11的内表面上。在未锁定的位置,锁定设备70(参见图6和7)开始与内螺纹12的啮合,允许固定元件30在通道14中自由地运动。当在锁定位置时,优选地锁定设备70(参见图6和7)基本上与内螺纹12啮合,导致挤压啮合或压力,跨过安装元件50的远端内表面51应用到固定元件30上。
固定元件30被典型的改变形成为伸长的且连续的骨移植物,优选地是杆形状。替代性的固定元件可包括,但不限于,板、棒、绳、缆、弹性结构和动态固定元件(没有示出)。固定元件30可用塑料材料制造,优选聚醚醚酮(PEEK)聚合物。可选地,固定元件30可用选自如下的材料制造:碳纤维复合聚合物、生物相容性金属、形状记忆金属、可再吸收的聚合物、生物惰性聚合材料、热塑性聚合物、热固性聚合物和这些材料的任意组合。
参考图6和7,显示了锁定设备70,优选包括:固定螺钉元件20,其有外螺纹21用于与耦合元件10啮合,和鞍状元件50。正如图6所示,鞍状元件50被连接到固定螺钉元件20上,与固定螺钉元件20的远端25相邻。正如图4中所看到的,工具凹窝22被放置在固定螺钉元件20的近端,这样有助于插入紧固工具或仪器(没有给出)。圆柱型锁定小块23从远端25延伸。锁定小块23的尺寸被调节,允许插入到孔中,所述孔优选地位于鞍状元件50的中心面。固定螺钉元件20可用钛合金制造,优选地是合金Ti-6Al-4V。可选地,固定螺钉元件20可用选自如下的材料制造:CP钛、钴-铬、300系列不锈钢、碳纤维材料、碳纤维复合材料、可再吸收聚合物、生物惰性聚合材料、热塑性聚合物、热骨性聚合物和这些材料的任何组合。
鞍状元件50优选地包括近端介面表面54(参见图10),其可接触远端面25,这是在锁定元件70(参见图6&7)将固定元件30稳定在耦合装置10中之后。正如图9和10中看到的,鞍状元件50可包括远端介面表面51,其被优选地构造,部分地围绕在固定元件50周围。远端介面表面51的形状和材料允许鞍状元件50可弹性地变形,且摩擦稳定固定元件30,这种情况是在锁定设备70以螺纹方式进入到耦合装置10中时。典型地,正如图9中所示,远端介面表面51的外周做成矩形。正如图10所示,凹的接受通道优选地位于远端介面表面51的中心面中,通常与矩形外周的长轴平行地走向。鞍状元件50包括至少一个孔52,其优选地从近端介面表面54通过,到达远端介面表面51。孔52可位于鞍状元件50的中心区域。孔52的中心线与近端介面表面54大约正交。孔52的内直径优选地被构造且调整尺寸,以接受锁定小块23。正如图9中所示,孔52优选地包括扩孔53,其中扩孔53相对于远端介面表面51的深度可根据构建材料变化,可在0.5mm至1.0mm的范围内。正如图12中所示,扩孔53够被构造且调节尺寸,以提供有喇叭口24的末端,以便保持在远端介面表面51的下面,且不与固定元件30的外表面接触,这种情况是当锁定设备70被完全啮合,且应用摩擦稳定固定元件30的加载在耦合元件10之内时。鞍状元件50是用可变形材料制造的,优选地是聚醚醚酮(PEEK)聚合物。可选地,鞍状元件50可用另一种可变形材料制造,该材料选自碳纤维复合聚合物、UHMWPE、形状记忆金属、可再吸收聚合物、生物惰性聚合材料、热塑性聚合物、热固性聚合物和这些材料的任意组合。优选地,用于包括鞍状材料50的材料的挠曲模量与固定元件30的挠曲模量相等或类似。鞍状元件50的挠曲模量的优选范围是在大约30至115Mpa之间。
正如图11所示,骨锚40典型地构造为骨螺钉,尽管,可选的骨锚可被使用,包括但不限于,骨固定立柱(没有给出)、骨科U形钉(没有给出)、钩子(没有给出)和可移动的头螺钉(没有给出)。本技术领域的普通技术人员应该理解到,所描述的骨锚耦合装置结构仅仅是举例的,其它结构也可被使用,包括被构造完整地耦合到骨锚40上的耦合装置10。
连接鞍状元件50至固定螺钉元件20的组合过程典型地包括将固定螺钉元件20放置在扁平表面上的步骤,所述扁平表面有远端25,是垂直的。近端介面表面54被放置在远端25上。鞍状元件50必须被对齐,以允许锁定小块23通过孔52,且突出在扩孔53的边缘上。优选地,组合过程中的下一个步骤是变形载荷被应用到锁定小块23的末端上,从而在锁定小块23的末端上产生喇叭口24,如图12中所示。喇叭口24与扩孔53的内肩膀接触,如图12中看到的,且基本上禁止鞍状元件50相对于固定螺钉元件20的任何轴向平移运动。喇叭口24不允许鞍状元件50相对于固定螺钉元件20的旋转运动。
固定脊柱的方法的步骤包括,首先提供骨固定系统60,其包括骨锚40、固定元件30、耦合装置10和锁定设备70。耦合设备10可被构造,以便将固定元件30耦合到骨锚40上。锁定设备70被构造,以便可操作地与耦合装置10相关。锁定设备70包括鞍状元件50,其连接到固定螺钉元件20上,鞍状元件50是用可变形材料制造的。该方法的下一个步骤是优选地将固定元件30定位在位于耦合装置10的通道14中。下一个步骤是启动锁定设备70啮合到耦合装置10上。固定脊柱的方法的最后一个步骤是通过螺纹方式将固定螺钉元件20向下推进到耦合臂11中,使鞍状元件50接触且部分地挤压通道14中的固定元件30。优选地,锁定设备70被充分地推动,以便将固定元件30摩擦地容纳在耦合装置10中。
尽管此处详细地说明且描述了优选的实施方案,但相关技术领域的普通技术人员将显而易见的明白,可做各种修改、添加和取代,只要不背离其本质,因此这些被认为在下述权利要求的范围内。

Claims (13)

1.一种锁定设备,使用在骨固定系统中,所述骨固定系统包括骨锚、耦合装置和固定元件,其中所述耦合装置被构造,以便将固定元件耦合到骨锚上,所述锁定设备包括:
一个固定螺钉元件,可操作地与耦合装置相关,用于将固定元件稳定在所述耦合装置内;和
一个鞍状元件,附着在固定螺钉元件上,所述鞍状元件是用可变形的材料制造的,包括远端介面表面和近端介面表面,其中所述远端介面表面被构造,部分地围绕在所述固定元件的周围,并且所述近端介面表面被构造,以便耦合到所述固定螺钉元件上。
2.如权利要求1的锁定设备,其中所述可变形材料包括第一塑料材料,并且其中所述固定元件包括第二塑料材料。
3.如权利要求2的锁定设备,其中所述第一塑料材料和第二塑料材料中的至少一种包括聚醚醚酮材料。
4.如权利要求1的锁定设备,其中所述固定螺钉元件包括远端、近端和中心轴,所述中心轴在远端和近端之间延伸,其中锁定小块从远端延伸出来,并且近端被构造以便有助于通过插入工具耦合到其上。
5.如权利要求1的锁定设备,其中固定螺钉元件被构造,通过螺纹方式啮合耦合装置,其中固定螺钉元件通过螺纹方式进入到耦合装置中,导致给鞍状元件施加了负载,且将固定元件稳定在鞍状元件和被耦合到骨锚上的耦合装置之间。
6.一种骨固定系统,所述骨固定系统包括:
骨锚;
固定元件;
耦合装置,其中耦合装置被构造,可操作地连接骨锚和固定元件;和
锁定设备,其中锁定设备可操作地连接至耦合装置上,以便将固定元件稳定在耦合装置内,其中锁定设备包括:
固定螺钉元件,被构造,通过螺纹方式啮合耦合装置;和
鞍状元件,附着在固定螺钉元件上,鞍状元件是用可变形材料制造的。
7.如权利要求6的骨固定系统,其中鞍状元件包括一个远端介面表面和一个近端介面表面,其中远端介面表面被构造成形,部分地围绕在固定元件周围——当固定元件被稳定在耦合装置和锁定设备之间时,并且近端介面表面被构造,以便耦合到固定螺钉元件上。
8.如权利要求6的骨固定系统,其中鞍状元件包括第一可变形材料,其中固定元件包括第二可变形材料。
9.如权利要求8的骨固定系统,其中第一可变形材料和第二可变形材料中的至少一种材料包括聚醚醚酮材料。
10.如权利要求6的骨固定系统,其中固定元件包括矫形杆,其有第一端、第二端和在两个端之间延伸的纵轴,其中当锁定设备使用时,固定元件被接受在耦合装置之内,且锁定设备沿着纵轴啮合固定元件。
11.如权利要求10的骨固定系统,其中固定元件是用缺口敏感材料和可断裂材料中的至少一种制造的。
12.如权利要求6的骨固定系统,其中固定螺钉元件包括远端、近端和中心轴,所述中心轴是在远端和近端之间延伸,其中锁定小块从远端延伸出来,而且,近端被构造,以便有助于通过插入工具耦合到其上。
13.如权利要求6的骨固定系统,其中固定螺钉元件被构造,以便通过螺纹方式啮合耦合装置;其中固定螺钉元件通过螺纹方式进入到耦合装置中,导致给鞍状元件施加了负载,且将固定元件稳定在鞍状元件和被耦合到骨锚上的耦合装置之间。
CNA2007800173795A 2006-05-01 2007-04-26 用于骨固定系统、使用固定螺钉元件和可变形鞍状元件的锁定设备和方法 Pending CN101442947A (zh)

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