CN1901853A - 多块同种异体移植植入物 - Google Patents
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Abstract
用于在进行椎间融合时使用的同种异体植入物(10)由两个部分形成。包括皮层骨的第一部分(20)为植入物提供了机械强度,允许在所治疗的椎骨之间维持适当的距离。包括松质骨的第二部分(30)是可延展的,并且促进新骨在所治疗的椎骨和植入物之间的生长,这样就使椎骨融合到植入物并且使椎骨彼此融合起来。植入物确定尺寸和形状为符合在椎骨之间的空间。形成在植入物的上部表面(14)和下部表面(16)上的齿(12)避免了植入物在短期内发生滑动。
Description
技术领域
本发明涉及同种异体植入物,并且更具体地涉及用于使椎骨融合起来的同种异体椎间植入物。
背景技术
许多病症,例如脊髓神经根压迫、退化性椎间盘疾病和外伤,可以引起剧烈的后背疼痛。椎间融合是缓解后背疼痛的外科方法。在进行椎间融合时,通过去除受到影响的椎间盘并且插入植入物,两个邻近的椎体融合在一起,植入物可以允许骨在两个椎体之间生长,以架接由于去除椎间盘而产生的间隙。
许多不同的植入物和植入材料已经用于融合而取得了各种各样的成功。当前用于椎间融合的植入物包括金属笼和同种异体移植物。金属笼的缺点是为了插入而需要对椎骨终板进行钻孔和攻螺纹。另外,在长期使用时,发生塌陷的几率是未知的。由于磁共振成像不能与金属笼相容,所以很难确定是否融合好了。
同种异体移植物是从像捐赠者的桡骨、尺骨、腓骨、肱骨、胫骨或股骨那样的长骨的骨干截取的骨段。使用已知的技术,对骨的截面进行截取和处理,以在植入之前保存同种异体移植物,并且减小在植入时发生免疫反应副作用的风险。例如,编号为4,678,470的美国专利披露了用于处理骨移植材料的方法,这种方法使用了戊二醛鞣皮法,以得到无抗原的生物相容的材料。同种异体移植物的机械性质甚至在处理之后也类似于椎骨的机械性质。这避免了应力屏蔽,而应力屏蔽对于金属植入物是在所难免的。它们也促进了骨的形成,即骨传导,并且也是磁共振成像相容的,从而更准确地确定是否融合好了。虽然就长期机械强度而言,同种异体移植物的骨传导特性实现了在同种异体移植物和椎骨之间的生物互锁功能,但在同种异体移植物和椎骨之间的界面的初始和短期机械强度需要解决,以使同种异体移植物在植入之后被迫出的可能性最小化。
虽然是按照所替换的椎间盘的大概高度进行切割,但大多数同种异体移植物只是没有为了使形状统一而确定尺寸并且/或对外部表面进行加工的骨段。因此,没能在最佳的解剖位置,或没能始终如一地沿着终板表面,对椎体进行融合。尽管外科医生可以在手术时对形状和尺寸进行小的修整以使同种异体移植物适合于患者的脊椎解剖结构,但在手术期间,由于同种异体移植物的特性,不可能对同种异体移植物的形状和尺寸进行大的修整。即使可以对形状和尺寸进行大的修整,外科医生用手将同种异体移植物的形状和尺寸修整到想要的尺度的能力也是有限的。
就给定的骨的整体结构而言,在骨各处的机械性质是不同的。例如,像股骨那样的长骨(腿骨)既具有皮层骨又具有松质骨。皮层骨,即包围骨髓腔的密质骨,通常是结实的,这样,皮层骨就承载了长骨的主要负荷。松质骨,即疏松的内部骨,通常是多孔的和可延展的,并且其密度大约只有皮层骨的三分之一到四分之一,其硬度大约只有皮层骨的十分之一到二十分之一,而其延展性大约是皮层骨的五倍。尽管松质骨的抗张强度大约为10-20MPa而密度大约为0.7,但皮层骨的抗张强度大约为100-200MPa而密度大约为2。另外,松质骨的断裂应变大约为5-7%,而皮层骨在发生断裂之前只能承受1-3%的应变。也应该注意到的是,这些机械特征可能由于许多因素而变差,例如任何应用到骨材料的化学处理和在获取之后但在植入之前的贮存的方式(即对骨进行干燥)。
值得注意地,由于与皮层骨比较松质骨的骨传导特性是更好的,用松质骨做成的植入物更容易与周围的接受者骨合并在一起。此外,人们已知,来自不同身体部位的松质骨具有一定范围的多孔性。这样,就可以对使用松质骨的植入物的设计进行定制,以特定地合并具有想要的多孔性的材料。
人们需要适当地利用皮层骨和松质骨的不同性质的同种异体移植物,用于改善稳定性并且促进新骨的生长,以在进行椎间融合期间,融合所治疗的椎骨。
发明内容
本发明涉及用于在对椎体进行外科融合的时候使用的同种异体椎间植入物。植入物优选地包括在尺寸和形状上符合邻近的椎骨的终板的楔形件或插入件,并且具有多个定位在顶部表面和底部表面上的齿,以与邻近的椎骨互锁在一起。齿优选地具有金字塔形状或锯齿形状。
植入物优选地包括两个或多个部分。至少第一部分优选地包括皮层骨,而至少第二部分优选地包括松质骨。植入物成形为使得当插入在所要治疗的椎骨之间的时候,同种异体移植物的皮层部分和松质部分定位为可以有效地利用皮层骨和松质骨所具有的不同性质。同种异体移植物的皮层部分与椎骨对准,从而使它承受了施加在植入物上的力的大部分,而松质骨区段促进新骨与植入物生长,以允许所治疗的椎骨与同种异体移植物融合在一起并且彼此融合在一起。
两个或多个区段优选地由燕尾结合部接附。一个或多个销也可以使用,以避免两个区段发生滑动而彼此断开连接。销可以由同种异体骨制造。优选地,两个或多个块或区段对准,从而当插入在椎骨之间的时候,使它们并排。
植入物优选地具有至少在同种异体移植物的皮层区段内形成的齿。由皮层骨形成的与松质骨相比硬度和刚性大得多的齿更有效地使得植入物免于移位。此外,由于植入物的皮层部分所处的位置承受了大部分的负荷,所以形成在这个部分内的齿所具有最大的能力抓入到椎骨表面内。齿也可以形成在松质骨区段或多个区段的部分内或形成在整个松质骨区段或多个区段内。
基于所要治疗的脊椎的区域,植入物可以具有多种外形和外部几何形状。植入物还可以成形为带有不同厚度,以维持在所治疗的椎骨之间的适当的距离。
附图说明
图1是根据本发明的植入物的示范性的实施例的透视图。
图2是图1的实施例的顶视图。
图3是图1的实施例的后视图。
图4是图1的实施例的侧视图。
图5是图1的实施例的局部顶视图。
图6是图1的实施例的局部侧视图。
图7是图1的植入物的顶视分解图。
图8是根据本发明的植入物的第二个示范性的实施例的侧视图。
图9是图8的实施例的后视图。
图10是根据本发明的植入物的第三个示范性的实施例的侧视图。
图11是图11的实施例的后视图。
图12是用于图7、8和10的植入物的可选择的齿形式的局部侧视图。
图13是显示了图1、8和10的实施例的有代表性的尺度的顶视图。
具体实施方式
图1显示了根据本发明的椎间同种异体移植间隔物或植入物10的第一个实施例的透视图。植入物10优选地成形为与在其之间使用了植入物10的椎骨的终板的至少部分的尺寸和形状相符。植入物10的外围可以确定尺寸和形状为与在其之间使用了植入物10的椎骨的终板的外围相配。可选择地,植入物10的外围可以确定尺寸和形状为只与椎骨的终板的外围的部分相配,或植入物10的外围可以在任何部位都不与椎骨的终板的外围相配。
植入物10大体上包括上部表面14、下部表面16和外部表面18。上部表面14和下部表面16还可以包括带有齿的区段15和平坦的区段17。上部表面14和下部表面16的带有齿的区段15的尺寸和形状可以大体上相同,带有齿的区段15朝向前端6形成,平坦的区段17朝向后端4形成。
植入物10优选地通过将第一部分20和第二部分30连接起来而形成。第一部分20优选地由皮层骨形成。第二部分30优选地由松质骨形成。第一部分20和第二部分30优选地由燕尾结合部40连接起来,从而使第一部分20和第二部分30彼此并排连接起来。第一部分20和第二部分30还可以包括第一孔28和第二孔38(未显示),销50可以插入经过第一孔28和第二孔38,以避免第一部分20和第二部分30沿着燕尾结合部40发生滑动。第一孔28可以形成为使它贯穿第一部分20的整个长度。第二孔38可以形成为使它贯穿第二部分30的整个长度,或只贯穿第二部分30的部分。销50可以插入经过第一部分20和第二部分30的整个长度,或只插入经过第一部分20和第二部分30的部分。销50可以确定尺寸为使得当销50完全插入的时候,销50从第一孔28或第二孔38突出出来。在这种情况下,通过进一步的处理,从第一孔28或第二孔38突出出来的销50的任何多余部分可以去除。可选择地,销可以确定尺寸为使它不会一直延伸经过第一孔28和/或第二孔38。
如图7所示,燕尾结合部40的凸部42可以形成在第一部分20上,而燕尾结合部40的凹部44可以形成在第二部分30上。然而,在可选择的实施例中,凸部42可以形成在第二部分30上,而凹部44可以形成在第一部分20上。凸部42可以具有优选地大概为3mm的长度z,在其最窄处具有优选地大概为3.1mm的第一宽度x,并且在其最宽处具有优选地大概为6.3mm的第二宽度y,而凹部44具有相应的尺度(查看图13)。在可选择的实施例中,凹部44所具有的尺度稍小于凸部42的尺度,这样就在凸部42和凹部44之间形成了干涉配合。然而,应该理解的是,在不偏离本发明的主旨和范围的情况下,凸部42和凹部44可以具有与上述尺度不同的尺度。另外,在形成植入物10时,多于一个的燕尾连接和/或多于一个的销连接可以使用。此外,销可以插入在可选择的部位内。此外,在不偏离本发明的主旨和范围的情况下,将第一部分20和第二部分30连接起来的其它方法可以使用。
植入物10具有多个形成在带有齿的区段14、16内的齿12,齿12优选地在植入物10和所要治疗的椎骨的终板之间实现了机械互锁。优选地,如图5和6所示,齿12可以是金字塔形状的,而从顶部到基部所形成的角度大概为60度。可选择地,齿12可以具有锯齿形状,而锯齿在前-后方向上走向(查看图12)。
如图1到4所示,带有齿的区段15的大部分包括第一部分20的整个上部表面14和下部表面16。因为这些齿12优选地由皮层骨形成,所以齿12具有足够的强度和硬度,以将它们刺穿到椎骨表面内,并且增强了与邻近的椎骨的互锁。为了简化制造过程(在下面进一步描述),齿12也可以形成在第二部分30内,虽然这些齿12不具有与形成在第一部分20内的齿12相同的强度和硬度。
齿12大体上排列成二维阵列或样式。在优选的实施例中,齿12所排列成的阵列包括均匀间隔开来的行和列。然而,本领域的那些技术人员可以容易地领会到的是,在不偏离本发明的主旨和范围的情况下,齿12可以在带有齿的区段15内以许多不同的方式排列。
优选地,平坦的区段17完全地包括在第二部分30的上部表面14和下部表面16上。与带有齿的区段15相比,由松质骨形成的平坦的区段17是更可延展的,并且可以发生变形,以符合所治疗的椎骨的表面轮廓。在不对植入物10的表面进行过度的轮廓修整的情况下,这还确保了在椎骨之间的植入物10的最佳配合,并且促进椎骨与植入物10融合在一起。
理想地,椎间植入物包括尽可能多的松质骨,同时提供充分的支撑,以维持在所治疗的椎骨之间的适当的间隔,从而最大程度地促进新骨的生长。通过适当地对植入物10的包括皮层骨的第一区段20确定尺寸和形状,并且通过适当地对准第一部分20从而使它易于受到由所治疗的椎骨施加到植入物10上的力的大部分的作用,植入物10的强度足以维持在椎骨之间的适当的距离,同时使所需要的皮层骨的量最小化。然后,植入物10的包括松质骨的其余部分(即第二部分30)可以更有利地用于促进新骨在所治疗的椎骨之间的生长,这样就为椎骨和植入物10提供了长期稳定性。因为第一部分20分担了植入物10所承受的负荷的大部分,所以增强了形成在第一部分20内的齿12抓入到椎骨的表面内的有效性。施加在第一部分20上因此施加在齿12上的力增强了齿12刺入到椎骨表面内并且抓住椎骨表面的能力,这样就避免了植入物10在短期内发生滑动,直到植入物10由于新骨的生长而与椎骨融合在一起。
这样,植入物10就利用了皮层骨和松质骨的不同性质,以改善在椎间融合的外科方法中对同种异体骨的使用。由于皮层骨和松质骨的不同组合可以基于所想要的性质进行选择,所以植入物10可以根据使用者的需要进行定制。由于否则可能不足够大来形成尺寸合适的植入物的同种异体骨的块可以替代地用于形成植入物10的一个部分,所以根据本发明的植入物10也允许更有效地使用可得到的材料。
在图1-4所显示的优选的实施例中,上部表面14和下部表面16彼此平行。然而,在脊椎的某些区域内,为了在去除受到影响的椎间盘之后恢复脊椎的自然弯曲,植入物10具有倾斜的和/或弯曲的表面,这可能是人们所想要。例如,如图8、9所示,植入物220可以具有楔形外形,上部表面214和下部表面216每个限定了角度θ。角度θ可以优选地在大约2到大约5度的范围内,并且角度θ优选地为大约3.5度。在又一个实施例中,如图10和11所示,下部表面116限定了角度,而上部表面114弯曲,以符合椎骨终板的局部解剖学的表面。角度可以优选地在大约2到大约5度的范围内,并且角度优选地为大约3.5度。上部表面114的曲率半径可以在大约8到大约25mm的范围内,并且上部表面114的曲率半径优选地为大约14mm。
在以上所图示的实施例中,并且如图13进一步所示,外部表面18形成为使后端4是平坦的,而前端6是弯曲的。前端6的曲率半径优选地在大约15到大约25mm的范围内,并且前端6的曲率半径优选地为大约20mm。植入物10从前端6到后端4的长度L优选地在大约10到大约15mm的范围内,并且植入物10从前端6到后端4的长度L优选地为大约12.5mm。第一部分20的长度l(包括凸的区段42)优选地在大约4到大约8mm的范围内,并且第一部分20的长度l(包括凸的区段42)优选地为大约6mm。植入物10在其最宽处从中间表面70到侧向表面72的宽度W优选地在大约10到大约18mm的范围内,并且植入物10在其最宽处从中间表面70到侧向表面72的宽度W优选地为大约15mm。此外,外部表面18的与带有齿的区段15相应的侧面5彼此平行,而外部表面18的与平坦的区段17相应的侧面7朝向后端4成角度α。角度α优选地在大约20到大约40度的范围内,并且角度α优选地为大约30度。就这种几何形状而言,植入物10可以理想地在颈椎之间使用。然而,本领域的那些技术人员可以容易地领会到的是,外部表面18可以具有许多不同的几何形状,以对植入物10在位于脊椎的不同区域的椎骨之间的使用进行优化。
通过首先由皮层和松质同种异体骨粗略成形第一部分20和第二部分30来制造植入物10。然后,燕尾结合部40的凸部42和凹部44分别形成在第一部分20和第二部分30内。用于销50的孔28和38也形成在第一部分20和第二部分30内。然后,凸部42插入在凹部44内,并且销50插入经过孔28和38。如果想要的话,粘合剂可以在第一部分20和第二部分30之间使用。在优选的实施例中,销50确定尺寸为使稍微的干涉存在于销50的外部表面和孔28和38之间。这样,通过在销50和孔28和38之间的干涉配合,销50就固定在孔28和38内。可选择地,粘合剂可以用于将销50固定到孔28和38内。然后,上部表面14和下部表面16的平坦的区段17和外部表面18成形为适当的想要的形式。最后,齿12形成到上部表面14和下部表面16内。在优选的实施例中,通过计算机控制的铣磨,对植入物10的部分和区段进行成形。然而,形成植入物10的多种部分的可选择的方法也可以使用。
使用上述的制造方法,齿12形成为使它们的顶部处在由平坦的区段17的表面限定的平面内或处在由平坦的区段17的表面限定的平面之下。在其它可选择的实施例中,齿12可以形成为通过在形成平坦的区段17之前首先在上部表面14和下部表面16上形成齿12,使齿12延伸通过平坦的区段17的平面。此外,通过在将第一部分20与第二部分30结合在一起之前将齿12铣磨到第一部分20的上部表面14和下部表面16上,齿12可以只由皮层骨形成。然而,这可能增加了制造过程的复杂性。
为了在去除受到影响的椎间盘之后使椎间空间恢复到适当的尺寸,植入物10的高度h确定尺寸为与所去除的椎间盘的高度相配。典型地,就椎间盘切除术而言,h在大约5mm到大约12mm之间,但其它高度可以使用。
植入物10也可以构造为用于椎体切除术。在这种情况下,应该注意到的是,植入物10可以构造为使h为大概10到大概150mm。其它高度也可以使用。这些较大的尺寸可以在椎体切除术即去除几块椎骨段的外科手术中使用。植入物10插入在由所去除的骨段形成的空间内。由于椎体切除术的特性,在手术之前准确地确定所需要的植入物的尺寸是非常困难的。这样,植入物10就可以由外科医生切割成适当的尺寸。在这种情况下,植入物10可以优选地只在上部表面14或下部表面16上具有齿12。
带有螺纹的孔(未显示)可以沿着外部表面18形成在植入物10的前端6、侧向表面72或中间表面70上,用于容纳插入件,以将植入物植入在椎骨之间。可选择地,特定地构造为通过沿着外部表面18的至少部分例如在植入物10的前端6和中间表面70和侧向表面72的部分进行紧贴装配来保持植入物10的仪器也可以使用。除了上述的方法或作为上述方法的替代,用于插入植入物10的其它方式也可以使用。
尽管上述的实施例包括了由单一块的皮层骨和单一块的松质骨形成的部分,但应该意识到的是,根据本发明,多个块的皮层骨和/或松质骨可以用于形成植入物的部分。也应该意识到的是,尽管上述的实施例由结合在一起的两个部分形成,但由多于两个的部分形成的植入物也在本发明的主旨和范围内。
尽管显而易见的是,在这里所披露的说明性的实施例实现了在上面所陈述的目的,但应该意识到的是,许多更改和其它实施例可以由本领域的那些技术人员设计出来。因此,应该理解的是,后附的权利要求书旨在覆盖所有这样的在本发明的主旨和范围内的更改和实施例。
Claims (12)
1.一种具有上部表面和下部表面的椎间植入物,其包括:
包括皮层骨的第一部分;和
包括松质骨的第二部分;
在其中,
第一部分和第二部分用燕尾结合部连接起来;
通过将第一部分和第二部分组合起来,形成上部表面和下部表面;和
大致上,第一部分的整个上部表面和下部表面还包括多个齿。
2.根据权利要求1所述的植入物,其特征在于,齿排列成二维阵列,齿具有金字塔形状。
3.根据权利要求1所述的植入物,其特征在于,植入物具有楔形外形,以有助于恢复椎间盘高度和脊椎弯曲。
4.根据权利要求2所述的植入物,具有大于后部高度的前部高度,以形成楔形外形。
5.根据权利要求1所述的植入物,其特征在于,顶部表面和底部表面是平行的,并且以近似椎间盘的高度的距离间隔开来。
6.根据权利要求1所述的植入物,其特征在于,顶部表面是弯曲的表面,其确定轮廓为模仿邻近的椎骨的终板。
7.根据权利要求1所述的植入物,还包括通过将第一部分和第二部分组合起来而形成的外部表面,在其中,外部表面被处理成预定的形状。
8.根据权利要求1所述的植入物,其特征在于,植入物还包括销,在其中,销将第一部分和第二部分连接起来。
9.根据权利要求1所述的植入物,其特征在于,第一部分和第二部分通过粘合剂连接起来。
10.一种制造具有上部表面、下部表面和外部表面的椎间植入物的方法,其包括以下步骤:
由皮层骨形成第一部分;
由松质骨形成第二部分;
使用燕尾结合部将第一部分和第二部分连接起来;和
在上部表面和下部表面上形成多个齿。
11.根据权利要求10所述的方法,其特征在于,形成第一部分的步骤还包括形成燕尾结合部的凸部,并且在其中,形成第一部分的步骤还包括形成燕尾结合部的凹部。
12.根据权利要求11所述的方法,其特征在于,形成第一部分的步骤还包括在凸部内形成孔,并且在其中,形成第二部分的步骤还包括在第二部分内形成孔,并且在其中,该方法还包括以下步骤:
形成销;和
在第一部分连接到第二部分之后,将销插入经过在凸部和凹部内的孔。
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2004
- 2004-09-01 US US10/931,788 patent/US7226482B2/en active Active
- 2004-09-02 BR BRPI0414078-8A patent/BRPI0414078A/pt not_active Application Discontinuation
- 2004-09-02 NZ NZ546053A patent/NZ546053A/en unknown
- 2004-09-02 WO PCT/US2004/028544 patent/WO2005020861A1/en active Application Filing
- 2004-09-02 EP EP04782938A patent/EP1670396A4/en not_active Withdrawn
- 2004-09-02 CA CA2537122A patent/CA2537122C/en not_active Expired - Fee Related
- 2004-09-02 KR KR1020067004363A patent/KR101106427B1/ko not_active IP Right Cessation
- 2004-09-02 CN CN2004800322211A patent/CN1901853B/zh not_active Expired - Fee Related
- 2004-09-02 AU AU2004268673A patent/AU2004268673B8/en not_active Ceased
- 2004-09-02 JP JP2006525432A patent/JP2007503924A/ja active Pending
- 2004-09-02 ZA ZA200602137A patent/ZA200602137B/xx unknown
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2007
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Also Published As
Publication number | Publication date |
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KR101106427B1 (ko) | 2012-01-18 |
CA2537122A1 (en) | 2005-03-10 |
AU2004268673B8 (en) | 2010-07-08 |
KR20070097290A (ko) | 2007-10-04 |
NZ546053A (en) | 2008-12-24 |
AU2004268673A1 (en) | 2005-03-10 |
WO2005020861A1 (en) | 2005-03-10 |
US7226482B2 (en) | 2007-06-05 |
US20070208424A1 (en) | 2007-09-06 |
BRPI0414078A (pt) | 2006-10-24 |
CA2537122C (en) | 2012-02-07 |
US20050113918A1 (en) | 2005-05-26 |
CN1901853B (zh) | 2011-07-06 |
AU2004268673B2 (en) | 2010-06-03 |
US7601173B2 (en) | 2009-10-13 |
JP2007503924A (ja) | 2007-03-01 |
ZA200602137B (en) | 2007-08-29 |
EP1670396A1 (en) | 2006-06-21 |
EP1670396A4 (en) | 2011-09-28 |
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