CN104780870B - 可编程植入物和使用可编程植入物修复骨结构的方法 - Google Patents

可编程植入物和使用可编程植入物修复骨结构的方法 Download PDF

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CN104780870B
CN104780870B CN201380055597.3A CN201380055597A CN104780870B CN 104780870 B CN104780870 B CN 104780870B CN 201380055597 A CN201380055597 A CN 201380055597A CN 104780870 B CN104780870 B CN 104780870B
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implant
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CN104780870A (zh
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J·亨特
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4 Network Cos
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4 Network Cos
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Abstract

本文描述了植入物系统和相关装置及其操作方法的各种实施方式。在各种实施方式中,用于与骨结构连接的植入物包括网结构,所述网结构包括被配置以与人骨组织连接的空间桁架。所述空间桁架包括具有在多个节点处接合的多个支柱的两个或更多个平面桁架单元。植入物为施加在骨结构位点的预期应力而被优化。

Description

可编程植入物和使用可编程植入物修复骨结构的方法
发明背景
1.发明领域
本发明总体涉及医疗装置,更具体地,涉及植入物。
2.相关技术的描述
植入物可以用于人和/或动物以支撑和/或固定一个或多个骨。例如,植入物可以用于脊椎以支撑和/或替换脊椎中的椎骨之间的受损组织。一旦植入在两个椎骨之间,植入物可以在两个椎骨之间提供支撑并且骨生长可以围绕和穿过植入物发生,以至少部分地融合两个椎骨用于长期的支撑。植入物可以包括具有固体材料的相对大的凸缘——例如,其可以覆盖与终板相互作用的50%的面积。该凸缘可以在植入物与椎骨终板之间提供接触面。大的凸缘可能有若干缺点。例如,大的凸缘可阻止骨生长并减少融合上下椎体的骨柱的大小。此外,大的凸缘优先支撑并使负荷区域化,防止力的分配并调节响应。使负荷局部化的过程还用于使椎体的其它区域欠负荷,从而根据负微应变激活局部吸收。
脊椎植入物可以包括开放的通道,所述通道以上/下方向穿过支撑凸缘的中心。开放通道设计可能需要植入物的构件,所述构件将与椎骨终板相互作用的凸缘分开,以吸收椎骨终板之间的压缩力。这可以增加对椎骨终板的较小区域上的压力,并且可以潜在地导致椎骨终板中的应力集中(stress risers)。此外,虽然骨移植材料通常结合植入物使用来促进骨生长,但植入物的开放柱设计可以降低骨移植材料将其本身固定到植入物的可能性,这可能导致不利于促进良好融合的生物机械协同作用。
骨移植材料可以在高压状态下充填到植入物中,以防止当骨移植材料在被放置在椎骨终板之间时脱离植入物。由于植入物和椎骨终板之间的移动或者在固定植入物过程中所承受的压缩力,高压状态也可以降低骨移植材料松动的可能性。此外,高压环境可以允许骨移植材料在更大的强度下进行重塑和融合。但是,高压状态可能难以产生并维持植入物中的骨移植材料。特别是,本体移植附着的缺乏不能完全接收或整合正常动力学范围内所期望的差异负荷。
发明概述
本文描述了植入物系统的各种实施方式和相关设备,以及其操作方法。在各种实施方式中,用于与骨结构连接的植入物包括网结构,所述网结构包括空间桁架,所述空间桁架被配置用于与人骨组织连接,所述人骨组织包括细胞、基质和离子环境。空间桁架包括具有在节点处接合的多个支柱的两个或更多个平面桁架单元。
在实施方式中,用于与骨结构连接的植入物包括:由在节点处接合的多个支柱形成的网结构,其中所述网结构被配置用于与人骨组织连接。支柱的直径和/或长度和/或网结构的密度是预先确定的,使得当网结构与骨结构、其基质或衍生其的细胞接触时,至少部分支柱产生在约1με和约5000με之间、或在约500με和2000με之间、或在约1000με与约1500με之间的微应变,所述微应变被转移到附着成骨细胞、骨基质或层状组织,或者转移到间隔压缩的负反射和与弯曲、延伸、扭矩或其组合中的负荷的共振。这些范围被优化为已知的负荷响应动力学,意思是引导而不是对活动和响应的限制。支柱的直径和/或长度是预先确定的,以使在负荷期间至少部分支柱产生在附着成骨细胞、骨基质或层状组织的长度上的改变,该改变在约0.05%至约0.2%、或约0.1%至约0.15%之间,引起成骨反应。支柱可以具有在约1mm至约100mm之间的长度。支柱的直径是可以预先确定的,使得当网结构在与骨结构接触时,支柱产生在约0.05%和0.2%之间的附着成骨细胞的长度上的改变。另外,支柱的直径是可以预先确定的,使得支柱发生在约0.000125%和0.0005%之间、或在约0.00025%和0.000375%之间的长度改变。在某些实施方式中,至少部分支柱是由具有1mm至100mm的长度和在0.250mm和5mm之间范围的直径的支柱组成。
在实施方式中,用于与骨结构连接的植入物包括由在节点处接合的多个支柱形成的网结构,其中所述网结构被配置用于与人骨组织连接。在某些实施方式中,网结构包括第一骨接触表面和第二骨接触表面。包括空间桁架的支柱的第一部分具有不同于包括空间桁架的支柱的第二部分的物理性质。包括空间桁架的支柱的第一部分可以具有:不同于包括空间桁架的支柱的第二部分的变形强度;限定的长度;直径;沿其长度的差异直径;密度;孔隙度;或这些物理性质的任意组合。在实施方式中,空间桁架包括从第一骨接触表面延伸到第二骨接触表面的一个或多个中心支柱,其中所述中心支柱具有大于或小于周围支柱的变形强度。在实施方式中,空间桁架包括平行于第一骨接触表面和/或第二骨接触表面而延伸的一个或多个纵向支柱,其中所述纵向支柱具有大于或小于周围支柱的变形强度。支柱的第一部分的直径可以大于支柱的第二部分的直径。用于形成支柱的第一部分的材料可以不同于用于形成支柱的第二部分的材料。
附图简述
本发明的优点得益于实施方式的如下详细描述并且在参考附图后将对本领域技术人员是明显的,其中:
图1A-1B图示了根据实施方式的具有前凸的植入物的视图;
图2A-2D图示了根据实施方式的无前凸的植入物的视图;
图3A-3B图示了根据实施方式的用三角形形状的构建单元形成的网结构;
图4A-4B图示了根据实施方式的植入物的内部网结构的顶部结构;
图5A-5C图示了根据实施方式的植入物的渐进截面图,其显示了植入物的内部结构;
图5D图示了根据实施方式的植入物的等距视图;
图6A-6D图示了根据实施方式的网结构的另一种构造;
图7图示了根据实施方式的随机网结构;
图8图示了根据实施方式的制造植入物的方法的流程图;
图9图示了根据实施方式的用于植入脊椎植入物的方法的流程图;
图10描述了穿过植入物分布的应力的图表;和
图11A-C描述了对成骨细胞的压缩的作用的示意图。
虽然本发明易于进行各种修改和具有各种可选择形式,但其具体的实施方式通过附图中的实例的方式被显示,并且在此将进行详细的描述。然而,应理解,附图和在此详细的描述意图不在将发明限于所披露的具体形式,而是与此相反,本发明意图是覆盖落入如所附的权利要求所限定的本发明精神和范围之内的所有修改、等价物和替代物。注意,标题只是为了组织的目的而并不意味着用来限制或解释说明书或权利要求书。
优选实施方式详述
图1A-1B图示了根据实施方式的植入物100的视图。例如,具体描述的植入物100可以用于前路腰椎体间融合术(ALIF)或后路腰椎体间融合术(PLIF),但是,应理解,植入物100可以具有适于骨融合应用的多种形状。在某些实施方式中,植入物100可以包括具有一个或多个桁架102(例如,平面桁架和空间桁架)的网结构。植入物100可以用于各种类型的人或动物的植入物,如脊椎植入物、椎体切除装置、膝部置换、髋部置换、长骨重建支架,以及颅颌面植入物、足部和踝部、手部和腕部、肩部和肘部(大关节、小关节、四肢以及定制的创伤植入物)。也可以考虑其它植入物用途。
本文所使用的“桁架结构”是具有一个或多个细长支柱的结构,所述支柱连接在称为节点的接合处。桁架可以包括普拉特(pratt)桁架、主柱(king post)桁架、后柱(queenpost)桁架、城镇格状(town’s lattice)桁架、平面桁架、空间桁架和/或弗伦第尔(vierendeel)桁架的变型(也可以使用其它桁架)。“桁架单元”是具有由三个或更多个细长支柱限定的边界的结构。
本文所使用的“平面桁架”是所有支柱和节点都基本上位于单个二维平面内的桁架结构。例如,平面桁架可以包括每个支柱基本上是直构件的一个或多个“桁架单元”,使得一个或多个桁架单元的全部支柱和节点基本上位于相同的平面。每个支柱基本上是直支柱和桁架单元的全部支柱和节点基本上位于相同的平面的桁架单元被称为“平面桁架单元”。
本文所使用的“空间桁架”是具有基本上不局限于单个二维平面的支柱和节点的桁架。空间桁架可以包括两个或更多个平面桁架(例如,平面桁架单元),其中两个或更多个平面桁架中的至少一个位于基本上不平行于其它两个或更多个平面桁架中的至少一个或多个平面的平面中。例如,空间桁架可以包括彼此相邻的两个平面桁架单元(例如,共享共同的支柱),其中每个平面桁架单元位于相对于彼此成角度(例如,彼此不平行)的单独的平面中。
本文所使用的“三角形桁架”是具有由三个直的支柱连接在称为节点的接合处形成的一个或多个三角形单元的结构。例如,三角形桁架可以包括在三个节点处彼此连接的三个直的细长支柱构件,以形成三角形形状的桁架。本文所使用的“平面三角形桁架”是所有支柱和节点基本上位于单个二维平面内的三角形桁架结构。每个三角形单元可以称为“三角形桁架单元”。每个支柱基本上是直的构件使得三角形桁架单元的全部支柱和节点基本上位于相同的平面中的三角形桁架单元称为“平面三角形桁架单元”。本文所使用的“三角形空间桁架”是包括一个或多个三角形桁架单元的空间桁架。
在各种实施方式中,网结构的桁架102可以包括用连接在不同节点处的直的或弯曲的/弓形的构件(例如,支柱)构造的一个或多个平面桁架单元(例如,平面三角形桁架单元)。在某些实施方式中,桁架102可以是微型桁架。“微型桁架”是具有足够小的尺寸的桁架,足以使多个微型桁架可以组装或以其它方式彼此连接,形成具有足够小的总尺寸(例如,高度,长度和宽度)的网结构,使得基本上所有网结构可以插入到植入位置(例如,两个椎骨之间)。因此,这种网结构和其微型桁架可以用来在整个网结构中接收和分配周围组织(例如,椎骨、骨等)的负载力。在一个实施方式中,形成微型桁架的支柱的直径可以是直径在约0.25毫米(mm)和5mm之间(例如,约0.25mm、0.5mm、0.6mm、0.7mm、0.8mm、0.9mm、1mm、2mm、3mm、4mm或5mm的直径)。在一个实施方式中,微型桁架可以具有小于约1英寸的总长度或宽度(例如,小于约0.9英寸、0.8英寸、0.7英寸、0.6英寸、0.5英寸、0.4英寸、0.3英寸、0.2英寸、0.1英寸的长度)。
例如,如图1A-1B所示,网结构可以在整个植入物100中延伸(包括植入物100的中心部分),以在整个植入物100中提供支撑。因此,植入物100的桁架102可以支撑植入物100抵抗张力、压缩力和剪切力。网结构也可以沿多个平面加强植入物100。例如,外部桁架结构可以提供支撑抵抗穿过植入物垂直作用的张力和压缩力,并且内部网结构可以沿包含各自桁架的不同平面提供支撑抵抗张力、压缩力和剪切力。在某些实施方式中,网结构包括形成具有多个支柱(例如,支柱103a-f)(支柱在本文中通常被称为“支柱103”)的三角形网结构的桁架102。
在一个实施方式中,植入物100的网结构可以包括至少部分地被外部桁架结构包围的内部网结构。例如,在一个实施方式中,网结构101可以包括内部网结构,所述内部网结构包括具有被外部桁架结构包围的至少一部分空间桁架的空间桁架,所述外部桁架结构包括用多个平面桁架单元形成的一个或多个平面桁架,所述多个平面桁架单元基本上位于单个平面中。图1A描述了具有内部网结构104和外部桁架结构105的植入物100的实施方式。在所示实施方式中,内部网结构104包括由多个平面桁架单元106限定的空间桁架,所述平面桁架单元106相对于彼此以一定角度连接,使得每个相邻的桁架单元与每个相邻的桁架单元不共平面。相邻的桁架单元可以包括两个桁架单元,所述两个桁架单元共享支柱和在共享支柱末端的各自两个节点。
在一个实施方式中,外部桁架结构105包括围绕植入物的外部、内部或其它部分连接的多个平面桁架。例如,在所示实施方式中,外部桁架结构105包括一系列彼此连接的平面桁架107a、b。平面桁架107a由虚线[-----]表示,平面桁架107b由点-虚线[-·-·-]表示。每个平面桁架由多个平面桁架单元(例如,三角形平面桁架单元)形成。如所描述的,平面桁架107a包括四个三角形平面桁架单元108a,b,c,d,其具有共同的顶点110并且被布置以形成位于单个共同平面中的大体上矩形的结构。也就是说,四个三角形平面桁架单元被布置以形成具有“X”形支柱的基本上成矩形的结构,所述“X”形支柱从矩形结构的一个角延伸到矩形结构的对角。如所描述的,基本上矩形的结构可以包括梯形形状。如下面将更加详细地描述的,梯形形状可以有利于提供包括前凸的植入物。前凸可以包括植入物的表面(例如,顶部和底部)的成角方向,其提供植入物的前后区域的厚度差异,使得植入物有利于支撑脊柱的弯曲。
在一个实施方式中,形成外部桁架的平面桁架彼此连接,并且沿至少一个轴线对齐。例如,在图1A中,平面桁架部分107a与相邻的平面桁架107b连接。平面桁架部107a,b在所有方向都不平行。但是,平面桁架部分107a,b被布置在至少一个方向(例如,在植入物100的顶部和底部表面之间的垂直方向)上彼此平行。例如,平面桁架107a,b和另外的平面桁架相对于彼此以一定角度顺序地布置,以形成大体上圆形或多边形形状的外壳,所述外壳具有由平面桁架限定的基本上垂直的壁和在垂直方向布置的平面桁架单元。
在一个实施方式中,外部桁架部分可以包括植入物的侧面、顶部和/或底部。例如,在一个实施方式中,外部桁架部分可以包括顶部区域、侧面区域和/或底部区域。图1A描述了植入物100的实施方式,其中外部桁架部分105包括顶部111、底部112和侧面区域113。如上所述,侧面区域113包括一系列垂直布置的平面桁架以形成圆形/多边形环状结构,所述环状结构完全地或至少部分地围绕设置在植入物100的中心部分的空间桁架的外周。在所述实施方式中,外部桁架结构105的顶部部分111包括多个彼此连接的桁架单元,以形成基本上覆盖内部网结构104的所有顶部区域的平面桁架。在所示实施方式中,顶部部分111完全横跨外部桁架结构105的侧面部分113的顶部边缘之间的区域。在所示实施方式中,顶部部分111由包括多个桁架单元的单个平面桁架形成,所述多个桁架单元基本上位于相同的平面中。换句话说,顶部部分111的平面桁架限定了大体上平的表面。虽然难以在图1中看到,但植入物100的下侧可以包括具有与顶部部分111相似构造的底部部分112。在其它实施方式中,外部桁架结构105可以包括局部侧面、顶部和/或底部外部桁架部分。或者可以不包括侧面、顶部和/或底部外部桁架部分中的一个或多个。例如,如下面将更加详细地描述的,图2C描述了植入物100的实施方式,所述植入物包括由空间桁架形成的内部网结构,其不具有外部桁架结构。
在某些实施方式中,植入物100可以由生物相容性材料,如钛合金(例如,γ钛铝合金)、钴、铬、不锈钢、聚醚醚酮(PEEK)、陶瓷等形成。也可以考虑其它材料。在某些实施方式中,植入物100可以通过下面进一步描述的快速成型工艺(例如,电子束熔炼(EBM)法)制成。其它工艺也是可行的(例如,注塑成形、铸造、烧结、选择性激光烧结(SLS)、直接金属激光烧结(DMLS)等)。SLS可以包括高性能聚合物的激光烧结,例如由总部在美国,Michigan,Novi的北美EOS公司所提供的高性能聚合物。高性能聚合物可以包括不同形式的PEEK(例如,具有多达约95兆帕(MPa)的拉伸强度和多达约4400MPa的杨氏模量以及在约180℃(356°F)和260℃(500°F)之间持续操作温度的HP3)。其它材料可以包括由北美EOS公司所提供的PA 12和PA 11。
如上所述,在某些实施方式中,网结构可以由多个三角形平面桁架单元形成。在某些实施方式中,平面桁架单元可以彼此连接以限定多面体,所述多面体限定内部网结构。可以通过连接平面桁架单元而建立的多面体结构的实例包括,但不限于,四面体、五面体、六面体、七面体、棱锥体、八面体、十二面体、二十面体和球体富勒烯。在某些实施方式中,如以上所述的那些,网结构的空间桁架可以连接四面体构建单元(building blocks)的多个中点,并且包括彼此相邻布置的四面体单元的有规律的图案。在某些实施方式中,网结构可以不包括几何构建单元的图案。例如,图7图示了可以用于植入物905的支柱的不规则的图案。也可以考虑其它网结构。由网结构构成的植入物的实例描述在美国公开专利申请号:2010/0161061;2011/0196495;20110313532;和2013/0030529中,其中的每一个在此通过引用并入。
图3A-3B图示了用空间单元形成的一部分内部网结构的示意图,所述空间单元由三角形平面桁架单元形成。三角形平面桁架单元可以连接在一起以形成还可以用作构建单元的四面体300a,b(也可以考虑来自三角形的其它图案)。也可以考虑其它构建单元(例如,方形形状的构建单元)。在某些实施方式中,网结构可以包括单个四面体,如单独或与一个或多个其它多面体组合的四面体300a或300b。在某些实施方式中,网结构可以包括两个或更多个四面体300a,b。四面体300a可以包括四个三角形面,其中四个三角形中的三个在每个顶点汇合。在某些实施方式中,两个四面体300a和300b可以一起放置于两个相邻的面,以形成具有六面体形状框架(包括六个面)的空间桁架313。六面体形状的空间桁架313可以包括第一顶点301、第二顶点309、第三顶点303、第四顶点305和第五顶点307。共同的平面311可以由两个四面体共享(例如,共同的平面311可以包括第三顶点303、第四顶点305和第五顶点307),以形成第一顶点301和第二顶点309与共同的平面311相隔开的六面体。如所描述的,三角形形状的构建单元的中心部分可以具有在其中心的空隙区域,其不包括穿过其延伸的任何另外的部件(例如,除了形成三角形形状的构建单元的支柱外没有构件)。
如图3B中所见,在某些实施方式中,多个六面体形状的空间桁架313可以以并排的方式布置。植入物100的两个空间桁架313可以经由它们的第一顶点301a,b通过支柱103r连接并经由它们的第二顶点309a,b通过支柱103t连接。类似地,两个空间桁架313可以经由它们的第一顶点301c,d通过支柱103p连接并经由它们的第二顶点309c,d通过支柱103s连接。其它的连接也是可行的。例如,空间桁架313可以直接通过侧面顶点连接(例如,直接通过相应的顶点(如顶点303a,b)和/或分享共同的支柱(如支柱103u))和/或通过侧面(例如,侧面111a,b)。
图4A图示了连接植入物100中四个六面体形状的空间桁架的第一顶点(分别用301a、301b、301c和301d表示)的另外的支柱103(例如,支柱103p和103r)。图4B图示了连接植入物100中四个六面体形状的空间桁架的第二顶点309(分别用309a、309b、309c和309d表示)的另外的支柱103(例如,支柱103s和103t)。在某些实施方式中,另外的支柱103也可以在网结构的一个或多个顶点之间内部使用,以形成另外的桁架(例如,参见图1A-2B中的网结构)(其它结构也是可行的)。
如图1A所示,植入物100的顶部表面115a和底部表面115b可以包括三角形、正方形、圆形或其它形状(例如,随机的或定制的设计)。顶部和底部表面115a,b可以用于连接在植入物100的网结构中使用的不同几何构建单元的顶部和底部顶点。例如,每个顶点可以通过支柱连接到其它几何构建单元的相邻顶点。顶部表面115a可以包括其它支柱网络和/或连接。在某些实施方式中,底部表面115b可以模仿(mirror)顶部表面(和/或具有其它设计)。在某些实施方式中,当植入物100被植入时,顶部表面115a和底部表面115b可以接合两个相邻椎骨的各自表面。
如图1B所示,植入物100可以包括前凸(例如,约在4至15度(如4、5、6、7、8、9、10、11、12、13、14或15度)范围内的顶部表面和/或底部表面115a,b的角度),以当被植入时进一步支撑相邻的椎骨。如上所述,前凸可以包括成角度的表面方向(例如,顶部和底部),其提供植入物的前后部分的厚度差异,使得植入物有利于支撑脊柱的弯曲。在所示实施方式中,植入物100的厚度在植入物的前部部分118或其附近较大并且在植入物的后部部分120或其附近较小。在所示实施方式中,外部桁架结构的侧面部分被基本上垂直地布置,并且前凸是由外部桁架结构的顶部部分111和底部部分112的角度形成。例如,在所示实施方式中,外部桁架结构的顶部部分111和底部部分112不垂直于由侧面部分113限定的垂直平面。相反,顶部部分111和底部部分112在植入物100的前部区域118处或其附近相对于侧面部分113的垂直平面以锐角布置,并且在植入物100的后部区域120处或其附近相对于侧面部分113的垂直平面以钝角布置。如所描述的,形成最接近植入物100的后部区域120的外部桁架结构的侧面部分113的平面桁架的垂直支柱比形成最接近植入物100的前部区域118的外部桁架结构的侧面部分113的平面桁架的支柱短。在所示实施方式中,其中垂直桁架基本上是均等间隔的,形成最接近植入物100的后部区域120的侧面平面桁架的“X”交叉构件的支柱比形成最接近植入物100的前部区域118的侧面平面桁架的“X”交叉构件的支柱短。其它实施方式可以包括在桁架的布置上的变化,以提供植入物的不同构造。例如,在某些实施方式中,顶部和底部的外部桁架部分中只有一个或没有可以非垂直于最接近植入物的前部和后部部分的外部桁架的侧面部分。此外,侧面、顶部和/或底部部分可以包括在任意方向上相对于彼此成角度的多个平面桁架。例如,顶部或底部部分可以包括四个平面桁架,每一个由多个桁架单元形成,使得该部分(或多个)包括棱锥体状形状。
在某些实施方式中,植入物可以不包括前凸。例如,图2A-2B图示了无前凸的植入物200的实施方式的两个示图。在某些实施方式中,顶部表面和底部表面可以不包括连接支柱。例如,图2C-2D图示了无外部支柱(例如,无由平面桁架形成的外部桁架部分)的植入物250的两个示图。在所示实施方式中,植入物250包括内部网结构,并且不包括外部桁架结构。例如,在所示实施方式中,植入物250的外部表面是由多个桁架单元限定的,所述桁架单元相对于其相邻桁架单元中的每一个成角度。桁架单元的相对对齐导致包括多个突出的交叉点的非平面外部。突出的交叉点(例如,突出的交叉点201)可以操作来深入周围骨中,以将植入物保持在合适的位置(例如,如果植入物正被用于椎体切除装置中)。
图5A-5C图示了根据实施方式的植入物100的渐进截面视图,其示出植入物100的内部结构。图5A图示了植入物100的较低部分的截面视图。底部表面115b显示有从底部表面115b向上延伸的不同支柱(例如,支柱103)。图5B图示了大约从植入物100中间穿过的截面视图。显示了由网结构中不同的堆叠四面体共享的支柱,如支柱103e,f。一些支柱延伸穿过植入物100的中心部分501a和/或501b。图5B也显示了植入物100的中心部分501a,b。在某些实施方式中,中心部分501a可以包括矩形区域,所述矩形区域具有植入物宽度的大约50%的宽度、植入物高度的约50%的高度以及植入物长度的约50%的长度,并且位于植入物100的中心。在某些实施方式中,中心部分501b可以在大约位于植入物100的一半宽度、大约一半长度和大约一半高度的位置(即,植入物100的中心)周围包括植入物100的大约1/8至1/4宽度的大约半径的区域(例如,球形区域、正方形区域等)。也可以考虑其它中心部分。例如,中心部分可以在大约位于植入物100的一半宽度、大约一半长度和大约一半高度的位置周围包括正方形区域,该正方形区域的一个侧面的长度为植入物100的大约1/4至1/2宽度。在图5D中显示了实例高度502a、宽度502b和长度502c。在某些实施方式中,高度可以高达约75mm或更多。在某些实施方式如用于长骨重建的那些中,宽度和/或长度可以大约为7英寸或更长。在某些实施方式中,宽度、长度和/或高度可以沿着植入物100而变化(例如,如果植入物包括前凸,则高度可以变化)。高度可以在相对侧面、中间之一处获取,和/或可以是沿植入物100的长度的一个或多个高度的平均值。网结构可以延伸穿过植入物的中心部分501a,b(例如,网结构的至少一个支柱可以至少部分地穿过中心部分501a)。图5C图示了另一个截面视图,其显示了网结构中的顶部四面体的截面图。图5D显示了包括具有顶点301a-d的顶部表面115a的植入物100的完整视图。
图6A-6D图示了植入物的可选实施方式。在某些实施方式中,可以使用六面体形状的几何设计的不同截面。例如,由图6A可见,可以使用六面体形状的几何设计的下半部(主要包括较低的四面体结构)。如果使用设计的下半部,植入物600可以成比例地扩展为具有与六面体形状的几何设计相似的总体尺寸(例如,四面体可以成比例地扩展为六面体形状的几何设计中四面体的大约两倍高度,以提供给植入物600与六面体形状的几何设计大约相同的高度)。在某些实施方式中,植入物600也可以成角度(例如,在顶部表面601a和/或底部表面601b上)以提供给植入物600前凸,在某些实施方式中,以在椎体终板之间具有更好的配合。顶部表面601a和/或底表面601b也可以包括支柱以连接植入物600的节点(例如,在图6A中所见顶部表面上的支柱网络)。也可以使用用于顶部表面601a和/或底表面601b的支柱的其它图案。在某些实施方式中,植入物600可以不包括支柱之间的负角度,因此可以容易通过铸造或成型工艺而建立。
图6C-6D图示了植入物的另一个可选实施方式。在某些实施方式中,六面体形状的几何设计的约中间40%至60%可以用于植入物650中。例如,如果六面体形状的几何设计的总体高度大约为37mm,则该设计的大约底部10mm和大约顶部10mm可以被移除,并且该设计的大约中间17mm可以用于植入物。然后植入物650的中间部分可以成比例地扩展,使得扩展的设计的大约高度可以是大约为37mm(或者所需的不同高度)。顶部表面651a和底部表面651b可以包括支柱的网络(例如,参见图6C的顶部表面651a上的支柱)(也可以考虑其它支柱网络)。植入物的设计的其它部分也被考虑(例如,图1A中所示的设计的上半部、图1A中所示的设计的下半部等)。设计部分可以成比例地扩展以满足规定的尺寸(例如,规定的高度、宽度和长度)。在某些实施方式中,可以减少支柱的数量,或者重新分配植入物中的材料,以使一些支柱可以具有较大的直径,而一些具有较小的直径(例如,不同的直径可以加强抵抗不同方向的力)。在某些实施方式中,可以使用局部设计的笼(例如,具有网结构的一半,使得结构包括四面体)。此外,在某些实施方式中,植入物可以包括成角度的表面(例如,成角度的顶部表面651a和/或成角度的底部表面651a),以为待植入椎骨终板之间的植入物提供前凸。
在某些实施方式中,当被植入时,植入物的网结构可以将力分布在整个植入物中。例如,网结构的连接支柱可以延伸到整个植入物的中心,并且支柱的相互连结性可以将压缩力的应力分散在整个植入物中,以降低应力提升的可能性(力在整个植入物中的分布可以防止应力集中在椎骨的一个或多个部分上,否则会导致对椎骨的损害)
在某些实施方式中,植入物的网结构(例如,植入物的外部和内部支柱)也可以为骨移植融合提供表面区域。例如,在整个植入物中延伸的网结构可以添加另外的表面区域(例如,在构成植入物的支柱的表面上),以融合至骨移植材料并防止骨移植材料从植入物松弛或迁移。在某些实施方式中,网结构还可以支撑骨长入。例如,当被植入时,相邻的骨(例如,相邻的椎骨,如果植入物被用作脊椎植入物)可以在至少一部分植入物的支柱上生长。骨生长和在骨生长和植入物之间的接合可以进一步稳定植入物。在某些实施方式中,植入物的表面可以由粗糙表面形成,以帮助骨长入附着。
在某些实施方式中,支柱可以具有大约在约0.025至5毫米(mm)的范围内(例如,1.0mm、1.5mm、3mm等)的直径。也可考虑其它直径(例如,大于5mm)。在某些实施方式中,支柱可以具有大约在0.5至20mm的范围内的长度(例如,取决于例如配合椎体终板之间的间隙所需的植入物尺寸)。作为另一个实例,支柱可以具有大约在30-40mm的范围内的长度,用于髋部植入物。在某些实施方式中,网结构的减小的支柱尺寸可以允许植入物100中的开放小室促进骨生长(例如,一旦植入物100被植入物到体内,骨可以通过开放小室生长)。植入物的平均沉降(subsidence)在手术后前3周内可以大约为1.5mm(其它沉降也是可行的(例如,大约在0.5至2.5mm之间))。在植入物到达植入位置后,大约匹配沉降的支柱尺寸(例如,直径大约为1.5毫米的支柱尺寸和大约1.5毫米的沉降)可以导致净的0阻抗(例如,在支柱周围生长的骨生长)。在植入物/椎骨终板界面的整个表面区域中的净的0阻抗可以导致较大的骨融合柱,其可以导致更稳定的融合。也可以考虑其它融合柱尺寸。植入物的构造可以在整个植入物中重新分配金属。在某些实施方式中,凸缘(rim)可以不被包含在植入物上(在某些实施方式中,凸缘可以被包含)。所产生的骨生长(例如,脊柱)可以通过植入物生长。
在某些实施方式中,植入物100的大于50%的内部体积可以是开放的。在某些实施方式中,植入物100的大于60%、大于70%和/或大于80%可以是开放的(例如,95%)。在某些实施方式中,开放的体积可以填充骨生长材料。例如,松质骨可以充填到植入物的开放/内部区域中。
在某些实施方式中,植入物的至少一部分表面可以用意图促进骨生长和/或骨附着的材料和/或防止感染的抗微生物剂涂布/处理。例如,在某些实施方式中,支柱的表面可以用生物制剂和/或骨生长因子涂布。在某些实施方式中,生物制剂可以包括涂料,如羟基磷灰石、骨形态发生蛋白(BMP)、胰岛素样生长因子I和II、转化生长因子-β、酸性和碱性成纤维细胞生长因子、血小板衍生生长因子和/或有助于在骨生长和植入物表面之间的良好生物学固定的类似骨生长刺激剂。在某些实施方式中,骨生长因子可以包括能够刺激细胞生长、增殖和细胞分化的天然存在的物质(例如,蛋白质或类固醇激素)。在某些实施方式中,植入物(例如,支柱、外部桁架结构等)的表面可以用胶原蛋白涂布。
在某些实施方式中,生物制剂和/或生长因子可以被固定到植入物的中心区域。例如,在某些实施方式中,生物制剂或生长因子可以在延伸穿过植入物100的中心部分501a和/或501b的至少一部分支柱上提供,参见图5B。这样的实施方式可以使生物制剂或生长因子能够递送到植入物的中心部分。例如,生物制剂或生长因子可以被物理固定到植入物的中心部分的支柱,而不是被充填到开放的体积中,该开放的体积不包括其中为生物制剂和/或生长因子的物理附着所提供的支柱。
当植入物到达植入位点时,沉降可以对骨移植材料(其可能已经承受植入物中的压缩力)施加额外的压力,并且起作用将骨移植材料推向植入物的侧面(根据相邻材料的布辛涅斯克理论,当力被施加到与其它材料相邻的部件(如砂、杂质或骨移植材料)时,抵抗部件的力在相邻材料中产生增加的压力(例如,60级(degrees))的区域)。植入物的支柱可以抵抗骨移植材料从网结构的侧面突出,并且可以增加骨移植材料的压力。骨移植材料可能需要在较高的压力环境下被植入以创建有利于强骨生长的环境(例如,根据沃尔夫定律,健康人或动物中的骨将适于其所处的负荷)。因此,网结构可以增加较强融合的机会。
也可以考虑由其它桁架构造形成的网结构。例如,桁架可以包括一系列充填三角形、两网(two-web)桁架、三网(three-web)桁架等。此外,用于植入物的网结构可以包括一个或多个桁架,如美国专利号6,931,812,题目为“Web Structure and Method For Makingthe Same”中所述,其公布于2005年8月23日,其在此通过引用整体并入,就像在此充分地和完全地陈述的那样。
图8图示了制造植入物的方法的流程图。在某些实施方式中,植入物可以通过快速成型(例如,电子束熔化、激光烧结等)制造。应注意,在下面所描述的方法的各种实施方式中,所述要素中的一个或多个可以同时、以与显示的所不同的顺序进行,或者可以被全部省略。也可以根据需要进行其它额外的要素。在某些实施方式中,部分或全部的方法可以通过计算机系统自动地进行。
在1001,生成植入物的三维模型并储存在控制器可访问的存储介质中,所述控制器可操作来控制植入物生产过程。在1003,材料(例如,粉末、液体等)层被施加到支架。在某些实施方式中,粉末可以包括γTiAl(γ钛铝合金),其可以是高强度/低重量材料。也可以使用其它材料。粉末可以使用气体雾化工艺形成,并且可以包括直径大约在20至200微米(μm)范围内(例如,大约80μm)的颗粒。粉末可以通过分配器输送到支架(例如,从储存容器中输送)。分配器和/或支架可以在分配期间移动,以将(例如,粉末)层施加至支架。在某些实施方式中,该层可以为大约均匀厚度(例如,具有20至200微米(μm)的平均厚度)。在某些实施方式中,分配器和支架可以不移动(例如,可以将材料喷到支架上)。在1005,控制器相对于材料层移动电子束。在某些实施方式中,可以移动电子束发生器,而在某些实施方式中,可以移动支架。如果材料为γTiAl,则大约在1200至1800摄氏度范围内(例如,1500摄氏度)的熔融温度可以在电子束和材料之间获得。在1007,在每次电子束经过之间,可以通过分配器施加额外的材料。在1009,去除未熔化的材料并冷却植入物(例如,使用冷却的惰性气体)。在某些实施方式中,可以使植入物的边缘平整以去除粗糙的边缘(例如,使用金刚石砂磨机)。在某些实施方式中,植入物可以包括粗糙的边缘以增加植入物和周围骨之间的摩擦,从而增加植入物对骨的黏合力。
制造植入物的其它方法也被考虑。例如,植入物可以被铸造或注射成型。在某些实施方式中,多个部分可以被铸造或注射成型并连接在一起(例如,通过焊接,熔融等)。在某些实施方式中,形成植入物的各个支柱可以单独生成(例如,通过铸造、注射成形等)并焊接在一起形成植入物。在某些实施方式中,不同尺寸的多个植入物可以被构建并以套件递送。在手术过程中,医疗卫生专业人员可以选择植入物(例如,根据所需的尺寸)。在某些实施方式中,多个植入物可以用在植入位点。
专用工具可以用于将本文所述的植入物插入。可以使用的工具的实例被描述在美国公开的专利申请号:2010/0161061;2011/0196495;20110313532;和2013/0030529中,其中的每一个在此通过引用并入。
图9图示了根据实施方式的植入脊椎植入物的方法的流程图。应注意,在下面所述方法的各种实施方式中,所述要素中的一个或多个可以同时,以与显示的所不同的顺序进行,或者可以被全部省略。也可以根据需要进行其它额外的要素。在某些实施方式中,部分或全部的方法可以通过计算机系统自动地进行。
在步骤1301,进入椎间间隙(intersomatic space)。例如,前部开口可以在患者体内制作,用于前路腰椎体间融合(ALIF)方法,或者后部开口可以被制成,用于后路腰椎体间融合(PLIF)方法。在1303,至少部分椎间间隙被切除以形成椎间间隙中的腔。在1305,将植入物插入到椎间间隙中的腔内。在某些实施方式中,处理器,或一些其它的装置,用于夹住植入物。在某些实施方式中,力可以被施加到植入物(例如,通过锤),以将植入物插入到腔中。在1307,在插入植入物之前和/或之后,植入物和/或腔中的间隙可以用骨移植材料充填。在1309,可以关闭椎间间隙的进入点(例如,使用缝线)。
在某些实施方式中,植入物可以被定制。例如,三维测量和/或植入物的形状可以用于构建将网结构分配到整个三维形状设计中的植入物。
在某些实施方式中,桁架/网结构可以布置在至少部分植入物上,以促进植入物连接到相邻的结构。例如,在植入物被植入相邻骨结构的情况下,一个或多个桁架结构可以布置在植入物的表面(例如,界面板(interface palte))上和/或从其延伸,所述植入物在使用期间意图接触并至少部分地附着至骨结构。在某些实施方式中,如包括布置在两个相邻椎骨的终板之间的椎骨间植入物的那些,一个或多个桁架结构可以被布置在椎骨间植入物的接触表面上,以促进增强椎骨间植入物连接至骨结构的骨生长。例如,桁架结构可以包括从接触表面延伸的一个或多个支柱,以限定用于穿过其的骨生长的开放空间,从而通过生长使骨能够将骨结构和桁架结构彼此相互锁定,以在接触面或其附近将植入物连接到骨结构。这种通过生长相互锁定的骨可以抑制植入物和骨结构之间的移动,否则可以导致植入物从预期位置的松动、迁移、沉降或移出。类似的技术也可以用于各种类型的植入物,包括意图与组织和/或骨结构连接的那些。例如,桁架结构可以用在膝部植入物的接触表面上、椎体切除装置中、髋部置换中、膝部置换中、长骨重建支架中,或者颅颌面植入物、髋部植入物、颌部植入物、用于长骨重建的植入物、足部和踝部植入物、肩部植入物或其它的关节置换植入物等中,以增强植入物对相邻的骨结构或组织的附着。可以从植入物的表面延伸以促进植入物连接至相邻的结构的桁架结构的实例和其它结构被描述在美国公开的专利申请号2011/0313532中,其在此通过引用并入。
虽然本文所述的植入物被描绘为是由基本上直的支柱构成,但应理解,支柱可以是非线性的,包括,但不限于弯曲的、弓形的和拱形形状。具有非线性支柱的植入物的实例被描述在美国专利申请号13/668968中,其在此通过引用并入。
已知成骨细胞在适当负荷下产生骨形态发生蛋白(“BMP”)。BMP是一组也称为细胞因子和代谢因子(metabologen)的生长因子。BMP充当标志骨形成(即,成骨反应)的形态发生信号。因此,通过增加一种或多种BMP的产生,增加了对植入物的成骨反应,产生整合到新形成的骨中的植入物。包括多个连接的桁架单元的网结构显示出响应负荷的若干变形。下面的图10描述了一些力,所述力沿构成网结构的桁架单元的支柱而分散。当用作骨植入物时,本文所述的网结构可以促进在网结构中和其周围的骨生长,这部分地因为增强的BMP产生。如图11A-C所示,成骨细胞变得粘附到网结构的支柱。在负荷下,支柱中的微应变导致局部的变形,其进而将应变转移至附着成骨细胞,导致成骨细胞流出BMP。
图11A描述了包括空间桁架410的植入物400的示意图。未示出的骨结构通常抵靠植入物400的顶部面420和底部面425而布置。在使用期间,当植入物被压缩时,来自接触骨结构的应力(用箭头430表示)可以导致植入物400伸长(用箭头435表示)。该伸长可以通过附着到植入物的成骨细胞而对BMP的形成产生有益的影响。相邻的骨增加了对倾斜支柱的压缩力。该压缩可以导致骨重建。两种力(压缩和伸长)的结合产生骨生长/重塑,其导致加速愈合并与预测(predicate)装置相比在较短时间量内实现成熟的融合。
图11B描述了植入物400的支柱415的近视图。在图11B中,支柱415以非伸长的状态被显示。当植入物不承受来自接触骨结构的负荷时,这可以表示支柱415的状态。成骨细胞被描述为附着到支柱415。成骨细胞以其正常的、非伸长的形式显示。图11C描述了在细长状态的支柱415,其当骨结构将压缩力施加至植入物400时而存在。如所示的,成骨细胞被认为是由于支柱415的伸长而拉伸。成骨细胞的伸长导致钙的流入,其随后转化为BMP并流出。研究表明,生成在500με和2000με之间或约1000με和约1500με之间的成骨细胞中的微应变增强了BMP的产生。可选地,当附着成骨细胞的长度在约0.05%和约0.2%之间或约0.1%和约0.15%之间改变时,可以实现BMP的产生。配置桁架系统来有意地产生成骨细胞中的伸长/微应变可以减少修复骨结构所需的时间。
在一个实施方式中,用于与骨结构连接的植入物包括网结构,所述网结构包括多个在节点处接合的支柱。网结构被配置以与人体的骨组织连接。在一个实施方式中,支柱的直径和/或长度是预先确定的,使得当网结构在与骨结构接触时,实现来自附着于植入物表面的成骨细胞的BMP产生。在一个实施方式中,支柱的直径和/或长度是预先确定的,使得至少部分支柱产生在约l和5000微应变、500με约2000με之间或在约1000με和约1500με之间的附着成骨细胞中的微应变。在一个实施方式中,支柱的直径和/或长度是预先确定的,使得至少部分支柱产生在约0.05%和约0.2%之间或在约0.1%和约0.15%之间的附着成骨细胞的长度变化。
可以制备植入物,其具有在约1至100mm之间的长度的支柱。支柱的直径可以被设置,使得当网结构与骨结构接触时,支柱经历在约0.05%和0.2%之间的长度变化。在某些实施方式中,支柱的直径是预先确定的,使得支柱经历在约0.000125%和0.0005%之间或在约0.00025%和0.000375%之间的长度变化。
本文所述的任何植入物都可以被修改使得形成网结构的至少一部分支柱产生附着成骨细胞的适当微应变/伸长。在某些实施方式中,如果不是所有则大部分形成植入物的网结构的支柱可以被“编程”(或设计),以刺激BMP产生。在其它实施方式中,一些支柱可以被编程/设计用于BMP产生,而其它支柱具有不同于编程的支柱的物理性质。
植入物可以被优化以分布植入物受到的应力。用于骨修复的大部分植入物被放置于将非均匀的应力施加至植入物的位置。非均匀的应力产生穿过植入物的不同的力。如果植入物被设计为承受一定均匀的力,则当经受非均匀的应力时,植入物可能失效。在非均匀的应力情况下,在植入物上的一些应力可以足够使植入物变形。具有为所预期的非均匀的应力而定制的植入物是期望的,所述应力将是在被修复的骨结构中所遇到的。
在实施方式中,用于与骨结构连接的植入物包括具有在节点处接合的多个支柱的网结构。网结构被配置以与人骨组织连接,并且具有第一骨接触表面和第二骨接触表面。为空间桁架的部分的支柱的第一部分具有不同于作为空间桁架的部分的支柱的第二部分的物理性质。以这种方式,植入物可以被产生,其优化了由植入物遇到的应力,以帮助阻止植入物的失效。
在一个实施方式中,作为空间桁架的部分的支柱的第一部分具有不同于作为空间桁架的部分的支柱的第二部分的变形强度。空间桁架可以包括从第一骨接触表面延伸到第二骨接触表面的一个或多个中心支柱。中心支柱可以具有大于或小于周围支柱的变形强度,这取决于植入物的位置。空间桁架可以包括平行于第一骨接触表面和/或第二骨接触表面而延伸的一个或多个纵向支柱,其中纵向支柱具有大于或小于周围支柱的变形强度。
植入物的支柱的物理性质可以是变化,使得支柱的第一部分的直径大于支柱的第二部分的直径。在某些实施方式中,支柱的第一部分由与用于形成支柱的第二部分的材料不同的材料形成。在某些实施方式中,支柱的第一部分具有与支柱的第二部分的直径不同的直径。在某些实施方式中,支柱的第一部分具有与支柱的第二部分的密度不同的密度。在某些实施方式中,支柱的第一部分具有与支柱的第二部分的孔隙度不同的孔隙度。这些不同的物理特性的任意组合都可以存在于植入物中,以帮助优化整个植入物中的应力分布。
在本专利中,某些美国专利、美国专利申请和其它资料(例如,论文)已经通过引用并入。但是,只有没有冲突存在于这样的文本与本文所述的其它陈述和附图之间,这样的美国专利、美国专利申请和其它资料的文本才仅通过引用并入。在这种冲突情况下,则在这种通过引用并入的美国专利、美国专利申请和其它资料中的任何冲突的文本并不通过引用具体地并入本专利中。
根据上述描述,在不同的实施方式中,植入物可以包括网结构。用于植入物的网结构可以包括微型桁架设计。在某些实施方式中,微型桁架设计可以包括具有多个支柱的网结构。也可以考虑其它网结构。网结构可以延伸到整个植入物(包括植入物的中心部分)。因此,网结构可以沿多个平面来增强植入物(包括内部植入物负荷承载),并为骨移植融合提供增加的区域。网结构可以用于植入物,如脊椎植入物、椎体切除装置、髋部置换、膝部置换、长骨重建支架,以及颅颌面植入物、足部和踝部、手部和腕部、肩部和肘部(大关节、小关节、四肢)中。也可以考虑其它植入物的使用。在某些实施方式中,用于植入物的网结构可以包括一个或多个几何体(例如,多面体)。在某些实施方式中,网结构可以不包括几何构建元件的图案(例如,支柱的不规则图案可以用于植入物中)。在某些实施方式中,网结构可以包括三角形的网结构,其包括两个或多个四面体。四面体可以包括四个三角形面,其中四个三角形中的三个在每个顶点汇合。网结构可以进一步包括在两个相邻面处放置在一起的两个四面体,以形成具有六面体形状框架的网结构(包括六个面)。在某些实施方式中,多个六面体形状的网结构可以以并列的方式排列。网结构可以通过侧顶点直接进行连接(例如,两个或多个六面体形状的网结构可以共享顶点)。在某些实施方式中,网结构可以成角度以向植入物提供前凸。
本发明的各个方面的进一步修改和可选的实施方式鉴于该描述对本领域技术人员可以是明显的。例如,尽管在一些实施方式中,支柱已经被描述并且描述为基本上直的细长部件,但支柱也可以包括沿其长度的至少一部分弯曲/成拱形的细长部件。因此,该描述应被解释为仅是说明性的,并且目的是为了教导本领域技术人员实施本发明的一般方式。应该理解的是,本文所示出和描述的本发明的形式将被看作是实施方式。构件和材料可以被本文描述和解释的那些所替代,部件和过程可以是相反的,并且本发明的一些特征可以独立地应用,在具有本发明的该描述的益处后,所有这些将对本领域技术人员是明显的。在本文所述的要素中可以做出改变,而不脱离以下权利要求中所述的本发明的精神和范围。此外,应注意的是,“可以”一词以自由选择的意思(即,有可能、能够)在整个申请中使用,而不是强制性的意思(即,必须)。术语“包括”,及其衍生词,意思是“包括,但不限于”。如本说明书和权利要求中所使用的,单数形式“一个(a)”,“一个(an)”和“该(the)”包括复数指代物,除非内容另外明确指出。因此,例如,提及“一个(a)支柱”包括两个或多个支柱的组合。术语“连接”意思是“直接或间接地连接”。

Claims (12)

1.用于与骨结构连接的植入物,其包括:
网结构,所述网结构包括在节点处接合的多个支柱,其中所述网结构被配置以与人骨组织连接;
其中所述支柱的直径和/或长度和/或所述网结构的密度是预先确定的,使得当所述网结构与骨接触时,所述植入物的所述支柱中产生微应变,其中所述支柱中的微应变被赋予附着至所述支柱的成骨细胞,并且
其中所述支柱的所述直径和/或长度和/或所述网结构的所述密度是预先确定的,使得至少部分所述支柱产生在0.05%和0.2%之间的附着成骨细胞的长度变化。
2.权利要求1所述的植入物,其中所述支柱的所述直径和/或长度和/或所述网结构的密度是预先确定的,使得所述支柱在负荷下产生附着成骨细胞的微应变,其中所述微应变是在刺激成骨细胞响应的范围内。
3.权利要求1所述的植入物,其中所述支柱的所述直径和/或长度和/或所述网结构的所述密度是预先确定的,使得至少部分所述支柱产生在1με和5000με之间的附着成骨细胞的微应变。
4.权利要求1所述的植入物,其中所述支柱的所述直径和/或长度和/或所述网结构的所述密度是预先确定的,使得至少部分所述支柱产生在500με和2000με之间的附着成骨细胞的微应变。
5.权利要求1所述的植入物,其中所述支柱的所述直径和/或长度和/或所述网结构的所述密度是预先确定的,使得至少部分所述支柱产生在1000με与1500με之间的附着成骨细胞的微应变。
6.权利要求1所述的植入物,其中所述支柱的所述直径和/或长度和/或所述网结构的所述密度是预先确定的,使得至少部分所述支柱产生在0.1%和0.15%之间的附着成骨细胞的长度变化。
7.权利要求1所述的植入物,其中所述支柱具有在1mm至20mm之间的长度,并且其中所述支柱的直径是预先确定的,使得当所述网结构与所述骨结构接触时,所述支柱产生在0.05%和0.2%之间的附着成骨细胞的长度变化。
8.权利要求1所述的植入物,其中所述网结构包括空间桁架,所述空间桁架包括两个或更多个平面桁架单元。
9.权利要求8所述的植入物,其中所述平面桁架单元中的一个或多个包括具有三角形构造中的三个直的支柱和三个节点的一个或多个平面三角形桁架单元。
10.权利要求8所述的植入物,其中所述平面桁架单元中的一个或多个彼此连接,使得一个或多个平面桁架单元所位于的平面不平行于与所述一个或多个平面桁架单元共享至少一个支柱的平面桁架单元的平面。
11.权利要求8所述的植入物,其中所述平面桁架单元中的一个或多个包括与第二平面三角形桁架单元连接的第一平面三角形桁架单元,其中所述第一和第二平面三角形桁架单元以相对的方式与单个节点连接,所述节点限定每个平面三角形桁架单元的顶点。
12.权利要求1所述的植入物,其中所述支柱中的至少一些限定具有至少一个节点的三角形桁架,所述至少一个节点由具有不同的对应角度的两个不同的三角形平面桁架单元共享。
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