CN107847327A - 用于骨植入物的多孔结构 - Google Patents

用于骨植入物的多孔结构 Download PDF

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Publication number
CN107847327A
CN107847327A CN201680040640.2A CN201680040640A CN107847327A CN 107847327 A CN107847327 A CN 107847327A CN 201680040640 A CN201680040640 A CN 201680040640A CN 107847327 A CN107847327 A CN 107847327A
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China
Prior art keywords
bone
layer
footed
loose structure
bone implant
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Granted
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CN201680040640.2A
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CN107847327B (zh
Inventor
E.鲍尔
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Waldemar Link GmbH and Co KG
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Waldemar Link GmbH and Co KG
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Abstract

本发明涉及一种包括本体的骨植入物，所述本体具有多孔结构(3)并且具有被构造成用于装配到骨、优选地骨缺损中的尺寸和形状。所述多孔结构(3)包括规则布置的基本单元(4)，所述基本单元(4)的内部空间形成互连孔，所述基本单元(4)由按层布置的基础元件形成，其中所述基础元件成形为像四足体(5,5')，每一层中的所述四足体(5)按平行取向布置并且被定位成相对于相邻层的四足体(5')在层中旋转。具有旋转和不旋转四足体的所述层交替布置。由此，可以实现多孔结构，其特征在于经改善的机械特性，从而导致经改善的生物相容性。本发明进一步涉及使用所述多孔结构的内用假体植入物以及一种此类骨植入物的方法。

Description

用于骨植入物的多孔结构
技术领域
本发明涉及一种由多孔材料制成的可植入骨增强件。本发明进一步涉及一种用于所述可植入骨增强件的制造方法。
背景技术
在外科手术中，特别是用于植入人工关节的外科手术，骨缺损的问题是经常遇到的情况。要填充这些缺损以便使缺损骨返回到其原始形状和尺寸。出于此目的，可以采用自体移植材料或同种异体移植材料。人工制成的同种异体移植材料在易用性和再现性方面具有优点。此外，合成制成的材料具有经受更严格质量控制和无任何疾病风险的优点。
已知假体元件和骨植入物具有像多孔结构一样的点阵。该多孔结构优选地具有规则几何形状，其目的是促进到周围骨组织的生物学固定。该多孔材料被构造成诸如促使周围骨到多孔材料的孔空间中的向内生长。通常，多孔材料和/或所施加的任何涂层可以包括钛合金、纯钛、钴铬、不锈钢、钽、锆和其它生物相容材料。此类增强件可以以不同形状和尺寸商业上获得。特定来说，由具有高孔隙度的金属泡沫材料制成的增强件由Zimmer有限公司制造和销售。(Trabecular Metal®)。
已知通过添加性方法（如选择性激光熔化(SLM)或电子束熔化(EBM)）来形成多孔结构。这些方法允许使用借助于熔化工艺从粉末固化材料的建立层的工艺用金属材料的成分制成产品。由此，以高精度，可以形成各种各样的所期望结构。例如，已知将多孔结构附接到髋臼内用假体的杯(US 8 454 705 B2)。该多孔结构通过EBM获得，并且形成具有开放单元的规则布置的点阵。这些单元按金刚石状构造来构造，其在各个平面中提供六角形形状的几何测量的优先级。在此专利的上下文中，术语“金刚石”或“金刚石状”涉及立方晶体结构，其是面心立方布拉维点阵。具有其六角形形状的金刚石结构具有相当高刚度的优点。然而，与相当强生物相容材料组合，所得总体刚度可能相当高。
发明内容
本发明的目的是提供一种在植入物的多孔结构的负荷承载特性方面的改善。
根据本发明的解决方案导致独立权利要求的特征。优选实施例是从属权利要求的主题。
在一种根据本发明的包括具有多孔结构并且具有被构造成用于装配到骨、优选地骨缺损中的尺寸和形状的本体的骨植入物中，多孔结构包括规则布置的基本单元，该基本单元的内部空间形成互连孔，其中所述基本单元由按层布置的基础元件形成，其中所述基础元件成形为像四足体，每一层中的四足体按平行取向布置并且被定位成相对于相邻层的四足体在其层中旋转。
可以提前解释一些术语：
“四足体”被所属领域的技术人员认为是具有从在四个不同方向上指向的共用中心发出的四个腿部以使这些腿部借助其自由端跨越四面体的元件。在许多情况下，这些腿部将具有相同或类似长度，虽然这不是必须的。具有不同长度的腿部产生其在腿部之间产生不同角度的优点。在所有腿部具有相同长度的情况下，腿部之间的角度将始终相同，即所谓的四面体角度，其被定义为arccos (-1/3)或大约109.47°。在腿部具有不同长度的情况下，产生不同角度，从而这些角度中的一些将小于四面体角度，并且优选甚至小于100°。令人惊讶地，发现，在限定基本单元的结构的元件中具有此类小角度提供骨组织的经改善向内生长，这是本发明增强装置的巨大优点。
接触表面是可植入骨增强件的表面，其被构造成在骨增强件的植入状态下与骨的表面接触。
节点是其中不同元件互连的点，特定来说其中一个四足体借助其腿部中的一者的远端连接到另一四足体的腿部中的一者的至少一个远端的点。
层之间的偏移关系意指所涉及层沿着由这些层限定的平面相对于彼此移位。该移位可以是平移、旋转或两者。
术语“相邻”层意指直接邻近的层。
延长中心线是沿着细长元件（特别是四足体的腿部）的中线的假想线，其延伸超过所述细长元件的物理极限。
术语“直接在下方”意指沿着四足体的第四腿部的延长中心线，该中心线延伸超过该四足体的中心。
本发明的核心是在不同层中布置基本单元的构思，其中这些基本单元由互连四足体形成，其中这些层交替移位以使一个层的四足体相对于其相邻下部层旋转。
令人惊讶地，具有此构造的多孔结构特征在于经改善机械特性，其中在空间中在一个方向上的杨氏模量不同于在另一方向上的杨氏模量。在不同方向上具有此类不同杨氏模量是生物相容性的巨大优点。这是因为天然骨的刚度通常是依赖于方向的，特别是对于大负荷承载骨，如人腿的股骨和胫骨（以及人腿的相应肱骨和腓骨）以及臀部的髋臼。如果与骨增强件的其他微结构相比（即具有按金刚石状点阵形成的基本单元），根据本发明的微结构的优点变得突出。虽然此类金刚石状结构由于其高杨氏模量而具有良好的负荷承载能力，但是其在所有主要方向上显示相同的高杨氏模量。就生物相容性而言，这是缺点，特别是对于骨增强件，因为天然骨如上文已经描述在不同方向上显示不同刚度。本发明克服此缺点，在优选实施例中更是如此，构造该偏移以使相邻下部层的节点定位在相邻上部层的四足体的顶部腿部下方，以使顶部腿部的延长中心线延伸穿过该节点。由此，负荷承载能力仅在垂直于层的平面的延长中心线的方向上进一步得以改善。
简而言之，为以其它方式规则布置的四足体的层的要求保护的移位布置在生物相容性方面提供意想不到的巨大改善。
优选地，旋转是平面内的，即，旋转轴线垂直于由层限定的平面。
任一层内的基本单元在每一基本单元内限定内部空间，并且此内部空间凭借偏移层间关系在空间的三个维度上不对称。空间的三个维度是标准正交系的基本方向，其中这些方向中的一者与限定基本单元的四足体的顶部腿部的方向一致。
换句话说，要求保护的构造提供多孔结构，其显著不同于已知金刚石构造。根据一个层的四足体与直接下一层的四足体之间的要求保护的相对旋转，由本发明提供一种新类型的基本单元，其几乎与金刚石基本单元一样紧凑，但是具有刚度在空间的所有三个方向上不均匀、而是根据方向变化的优点。由于天然骨、特别是骨的松质区段根据负荷方向正显示不同刚度，因此由本发明提供的多孔结构展现类似特性，并且因此实现更高程度的生物相容性。这是相当大的优点，因为如果骨材料相邻于具有不同刚度的植入物，则其往往退化。通过使刚度适于天然骨的特性方向变化，可以避免此不希望的退化。这是具有要求保护的本发明多孔结构的植入物的主要益处。
优选地，要求保护的旋转位置涉及导致倾斜位置的角度的真实旋转，360°或其倍数以及180°或倍数的旋转不被视为旋转，因为其涉及不旋转或仅倒置的不重要情况。
优选地，在每一层内，三个相邻四足体在节点中借助其腿部中的一者相互连接，并且这些节点限定所述层的基准平面，并且所述四足体的第四腿部大体垂直于基准平面取向。凭借此，在两个相邻层的四足体之间实现明确限定的横向偏移。对于在第四腿部的方向上施加在多孔结构上的任何负荷，将实现比在任何其它方向上高的刚度。进一步优选地，所述层的节点直接定位在相邻上部层的四足体的第四腿部下方。上述效果可以通过选择层之间的偏移以使相邻上部层的四足体的第四腿部直接指向相邻下部层的三个相邻四足体的节点来进一步增加。如术语“指向”所指示，所述第四腿部指向相邻下部层的节点，但是仍与其间隔开，即，所述第四腿部并不实际上接触相邻下部层的节点。
在优选构造中，四足体的腿部大体垂直或倾斜但不平行于基准平面取向。通过避免具有腿部平行于基准平面取向的四足体，大大促进多孔结构使用添加性制造方法（如电子束熔化(EBM)或选择性激光熔化(SLM)）的制造。更合理生产甚至可以通过凭借沉积和固化在适当位置、优选地在连续层中而形成四足体来实现。此可以通过上述EBM和SLM工艺实现。
在本专利的上下文中，四足体的标准取向应该是指向上的腿部（“顶部腿部”）中的一者和形成支座的其它三个腿部（“基部腿部”），其中这三个基部腿部的远端限定基准平面。优选地，基部腿部中的每一者与基准平面之间的角度大于20°，优选地在从25°至35°的范围内。凭借此，可以实现基部腿部的更陡峭布置，这允许经改善的制造，特别是通过上述方法。优选地，这三个基部腿部彼此等角取向，从而跨越等腰三角形。
进一步优选的是将四足体的第四腿部尺寸确定为比基部腿部更短。这允许基部腿部的更陡峭布置，同时维持由四足体的腿部跨越的四面体的一般形状。特别优选的是，根据基部腿部与基准平面的角度选择顶部腿部如此短，以使腿部的自由端跨越正四面体。由此，具有正（即，理想）四面体的优点与四足体的更坚固构造和制造组合，即，实现大大改善的实用性。此外，如上文已经解释，不同角度导致一些角度变得更小，这有益于促进骨组织的向内生长。
优选地，这些层交替移位以使一个层的四足体相对于相邻层的四足体旋转，优选地按具有旋转和不旋转四足体的层的交替布置。此类交替布置使高效制造与本发明的经改善植入物特性组合在一起。应注意，通过此类交替布置，仅需要两种不同类型的层，四足体处于其原始（不旋转）状态中的第一层和四足体旋转的第二层；所述第一和第二层将交替布置。这提供比已知金刚石状构造优越的具有所论述益处的规则结构。
多孔结构的优选材料通常是生物相容材料。其优选地选自包括钛合金、纯钛、钴铬、钽、不锈钢和锆的群组。进一步优选地，该材料是2级钛。这使优越生物相容性与良好强度和刚度特性组合在一起。另一优选材料是钛合金（例如Ti6Al4V）。此材料更经常使用，而且其具有稍高刚度。使此类生物相容材料用于基本单元可取消对保护涂层的需要，以便实现生物相容性。然而，这并不排除使基本单元的至少一部分设置有骨生长促进材料的涂层（特定来说磷酸钙(CaP)）的选项。由此，可以实现相邻天然骨材料到骨增强件中的更快速和彻底的向内生长。此外，该涂层可以被构造为PVD（物理气相沉积）涂层。其材料优选地选自包括铌、钽、锆及其氧化物（氧化铌、氧化钽和氧化锆）的群组。优选地，该涂层的厚度选择成在1 µm与10µm之间，进一步优选的小于7 µm。由此，即使具有此类额外涂层，也仍可以保持高度柔性，并且仍将实现孔在基本单元层面上的相对宽互连。此外，材料和厚度的组合实现将高度耐刻痕的涂层。
在可能有资格进行独立保护的进一步优选实施例中，可植入骨增强件还包括加强结构，其优选地由固体材料制成。由此，可以进一步提高在机械应力方面的坚固性，同时维持根据本发明的多孔结构的一般优点。优选地，该加强结构与多孔结构一体形成。优选地，该加强结构包括除多孔结构以外提供的固体本体结构，其中该多孔结构附接到该固体本体结构。进一步优选地，该固体本体结构和多孔结构形成为整体结构。由此，可以形成具有额外功能的更复杂骨植入物，如用于植入物的髋臼部分的杯。特别优选的是，骨植入物的高度和尺寸被构造成诸如可用于髋臼或肱骨杯，或者骨增强装置，优选地股骨、胫骨、髋臼或肱骨增强件。
根据本发明的可能值得独立保护的另一方面，提供一种包括由固体材料制成的本体和由多孔结构制成的骨接触部分的内用假体植入物，其中该多孔结构包括规则布置的基本单元，该基本单元的内部空间形成互连孔，其中这些基本单元由按层布置的基础元件形成，其中这些基础元件成形为像四足体，每一层中的四足体按平行取向布置并且被定位成相对于相邻层的四足体在其层中旋转。在优选实施例中，该本体是杯，优选地用于臀部内用假体的髋臼部分。凭借该杯，形成适当轴承以用于以铰接方式接合股骨部分的头部。由于与根据本发明的多孔结构的组合，机械声音清晰度与具有经改善生物相容性的锚定微结构组合，特别是关于从杯到髋臼中的应力加载和负荷传递。这比较适用于其中本体是用于肩部内用假体的杯的另一优选实施例。
在另一实施例中，本体是将多孔结构划分成不同区段的隔板元件。由此，可以实现，施用在本体的一侧上的接合剂将到达隔板的另一侧。在进一步优选实施例中，该本体是加强元件，并且由此提供额外机械强度。
另一优选实施例具有锥形形状，其具有从底部侧延伸到顶部侧并且被构造成诸如能够容纳内用假体的胫（优选地，臀部内用假体的股骨部分和/或膝盖内用假体的股骨和/或胫骨部分）的内部通道。
又一优选实施例构造成像脊柱融合器（spinal cage）。脊柱融合器是植入装置，其将布置在两个相邻椎骨之间的椎间空间中，代替被去除或缺损的天然椎间盘。由此，脊柱融合器防止椎间空间的塌陷。脊柱融合器的长期目标是通过生长到椎间空间中和内部的骨材料来实现两个相邻椎骨的融合。根据本实施例的脊柱融合器特征在于具有根据本发明的用于促进骨向内生长的多孔结构的多孔内芯。该内芯由外壳环绕。其由固体材料制成并且起着承载负荷力并保护内芯的多孔结构的双重作用。此外，在外壳的顶部侧和底部侧上，提供多个止动齿。其是金字塔形的用于使植入物在其适当位置处止动。此外，其逆着植入方向倾斜，由此促进植入并阻止逆着植入方向的不希望错位。
优选地，多孔结构被尺寸确定为使得平均孔宽度在0.1与1.5 mm之间、优选地在0.4与1.0 mm之间的范围内，并且限定孔的壁的四足体的腿部具有在0.2与1.0 mm之间、优选地在0.4与0.7 mm之间的厚度。
本发明进一步涉及一种用于制造骨植入物的方法，所述骨植入物包括具有多孔结构并且具有被构造成用于装配到骨、优选地骨缺损中的尺寸和形状的本体，其中所述方法包括通过使用沉积技术形成多孔结构来制造骨植入物，其包括：形成成形为像四足体的基础元件的交替层；按大体平行取向在每一层中布置所述四足体；相对于其前一层的四足体在每隔一层中旋转所述四足体；形成其内部空间形成互连孔的规则布置的基本单元，这些基本单元由按层布置的基础元件限定。凭借此方法，可以制造如上文详述的装置。关于进一步细节，请参见以上解释。
优选地，所述方法还包括如下步骤：提供所述骨植入物的三维模型；限定所述骨植入物的本体；限定所述骨植入物的骨接触表面，其被构造成补充所述骨的对应表面，其中至少所述骨接触表面被制造为多孔结构。由此，可以实现根据患者的具体需求制造的量身定做的骨植入物。采用EBM或SLM工艺实现此类植入物的精确且有效制造。
进一步优选地，该方法被构造成用于制造根据权利要求所述的骨植入物。
附图说明
在下文中，将根据组合附图以示例性方式更详细描述本发明。在附图中：
图1是显示根据本发明的骨植入物的多孔结构的基本单元的细节图；
图2是基本单元和形成其的四足体的示意图；
图3a-c 是多孔结构在空间的三个方向上的三个视图；
图4a, b显示包括板形增强装置的内用假体植入物的第一实施例；
图5a, b是板形增强装置及其变型的横截面图；
图6a显示包括节段增强装置的内用假体植入物的第二实施例；
图7a, b是节段增强装置的细节图；
图8是节段增强装置的横截面图；
图9显示成形为胫骨增强锥体的内用假体植入物的第三实施例；
图10 是胫骨增强锥体的横截面；
图11a-c显示成形为脊柱融合器的内用假体植入物的第四实施例的变型；
图12 是显示如现有技术中已知的金刚石状多孔结构的基本单元的细节图；
图13 是已知金刚石基本单元的示意图；以及
图14a-c是金刚石状多孔结构在空间的三个方向上的三个视图。
具体实施方式
在图1-3中显示将用于内用假体装置的各种实施例的多孔结构。
多孔结构3包括规则布置的基本单元4。在图1中显示基本单元及其周围环境的细节图。基本单元特征在于内部自由空间40，其与邻近基本单元4的内部自由空间互连。在图2中显示基本单元4的规则布置。由于图3a-c显示在空间的所有三个维度上（即，在右手坐标系中沿着x、y和z方向）的等角视图，因此可以了解，基本单元4按层规则布置，然而布置的细节如图2a-c的相互比较所示在不同方向之间不同。这是由于基本单元4的特定构造，如在下文中将更详细地解释。
基本单元4中的每一者由基础元件形成，其中基础元件成形为像四足体5。四足体5是具有在中心点50处连接的四个腿部51, 52, 53, 54的结构，腿部51, 52, 53, 54中的每一者远离中心点50指向并且借助其自由端跨越四面体。
该四面体可以是非正四面体或正四面体。任选地，形成等腰四面体，其中腿部51,52, 53, 54中的每一者将与其它三个腿部中的每一者形成相同角度α；在此情况下，角度α被定义为
，
其为大约109.47°。
在本专利的上下文中，四足体的标准取向应该是腿部51, 52, 53, 54中的一者（“顶部腿部”51）指向上并且其它三个腿部（“基部腿部”52, 53, 54）形成支座，其中三个基部腿部52, 53, 54的远端限定基准平面45。
为了形成基本单元4，三个相邻四足体5在节点55中借助其基部腿部52, 53, 54中的一者相互连接。第四四足体5'布置在所述三个相邻四足体5的顶部上，以使其基部腿部52', 53', 54'的自由端连接到所述三个相邻四足体5中的每一者的顶部腿部51的自由端。由此形成的空间是基本单元4的内部空间40。
如图3中可以最佳了解，第四四足体5'布置在与三个四足体5不同的较高层中。此外，可以容易了解，第四四足体5'被定位成使得其顶部腿部51'超过其中心50'的突出部笔直延伸穿过节点55，在节点55处相邻（即，直接下一）下部层的三个四足体5连接。换句话说，节点55被定位成诸如直接在相邻（即，直接下一）上部层中的第四四足体的顶部腿部下方。
基本单元4的此构造是本发明的多孔结构3的特性。优于如图12-14中所示的已知金刚石状结构的差别相当明显。在已知金刚石状结构中，不存在四足体的此类布置。其缺少使节点直接定位在相邻上部层的四足体下方的实质特征（参见图13）。所得基本单元显示在图12中。其在所有三个维度上是对称的，并且因此，多孔结构的刚度在空间的所有三个方向上相同，如图14 a-c中所示。在其中，具有相同或类似功能的元件由与图1-3中相同的参考编号表示。
由于此结构差别，本发明的多孔结构的总体刚度变成依赖于方向的，并且因此更接近天然骨的特性。
优选地，使用钛合金或纯钛作为多孔结构的材料。
多孔结构通过电子束熔化(EBM)工艺形成。这是用于制造的添加性工艺，并且可以产生固体或多孔材料。所期望材料的粉末以所期望粒度提供。通过EBM工艺，所期望材料的粉末在所期望位置处并且按所期望顺序（如在用于多孔结构的先前建模步骤中所限定）沉积在连续层中并且使其例如熔化以形成粘合体。任选地，涂层30通过物理气相沉积(PVD)工艺、优选地使用钽设置在多孔结构上；另一选择为，涂层30可以是磷酸钙(CaP)涂层。
在图4a, b中显示用于内用假体的骨植入物的第一实施例。其包括用于臀部内用假体的髋臼部分的髋臼杯6。髋臼杯6由如本领域中已知的固体生物相容材料制成。然而，由于将要植入髋臼杯6的天然骨中的缺损，可能需要提供用于增强的骨植入物7。骨植入物7是板状增强件，并且其特征在于固体内壁70以及在其内侧上的第一多孔结构71和在其外侧上的第二多孔结构72，多孔结构71, 72如上文所述构造。该固体内壁充当使多孔结构71, 72彼此隔离的隔板。由此，多孔结构71, 72可以用于不同目的。多孔结构71可以充当到髋臼杯6的接触表面。为粘附到髋臼杯6，可以使用接合剂69，其中接合剂61进入多孔结构的互连孔，并且因此提供强固定。
多孔结构72用于填充骨缺损。其可以包括由固体材料的内衬74覆盖的通路73，其在制造多孔结构72的同时使用相同工艺制造。由于根据本发明的多孔结构72的基本元件4的特殊构造，骨植入物7具有相当高刚度，由此提供经改善的负荷承载能力，特别是在增加的刚度的方向上。多孔结构72进一步促进骨向内生长，由此实现可靠的长期固定。对于初始固定附件，可以采用如接骨螺钉（未显示）等元件，其布置到通路73中。内衬74充当阻挡物以保持通路73不受可能干扰接骨螺钉的任何源自多孔部分的流入的影响和/或为所述接骨螺钉的头部提供负荷承载支撑。
在图5b中所示的变型中，块状芯部75设置在多孔结构72内。芯部75充当额外加强件，特别是提供经改善抗扭转性。
在图6a, b中显示用于内用假体的骨植入物的第二实施例。其包括用于臀部内用假体的髋臼部分的髋臼杯6。髋臼杯6由如第一实施例中的固体生物相容材料制成。然而，其关于骨植入物7'不同。被构造成用于相同或类似任务的类似组件由对应参考编号表示。在第二实施例中，骨植入物7'是成形为像球体的一段的段增强件。类似于第一实施例的板增强件，其包括内壁70'和在其两侧上的多孔结构71', 72'。多于一个骨植入物7'可以与髋臼杯6一起使用并粘附到髋臼杯6，然而为简单起见，仅显示一个。骨植入物7'可以包括由内衬74'保护的通路73'，如上文关于第一实施例更详细地解释的那样。
在图9和图10中显示骨植入物的第三实施例。其构造为将用于膝盖内用假体（未显示）的胫骨组件的胫骨增强锥体8。胫骨增强锥体8被构造成是胫骨的近侧端部处的缺损骨材料的替代物，从而填充由骨缺损导致的空隙。由此，形成完整基部，膝盖内用假体的胫骨组件可以附接到该基部。为此，胫骨增强锥体8使用根据本发明的多孔结构制造。多孔结构的第一部分81施加在胫骨增强锥体的内表面上，以便借助于骨接合剂（未显示）与穿过胫骨增强锥体8的内部空间的胫骨组件的轴进行接触。凭借高孔隙率，可以实现良好穿透性，从而提供坚固固定。多孔结构的第二部分82施加在胫骨增强锥体8的外表面上。其被构造成促进骨材料针对长期固定的向内生长。为避免施加在内表面处的接合剂的任何不希望的迁移，设置中间壁80。其充当隔板，从而阻挡接合剂到外侧上的多孔结构82中的流入。为避免胫骨增强锥体8的顶端处的任何溢出，设置顶部盖板83，从而封闭第一和第二多孔结构81,82的上表面。
在图11中显示骨植入物的第四实施例。其被构造为将布置到椎间空间中以用于促进两个相邻椎骨（未显示）的融合的脊柱融合器9。其充当椎间盘的替代物并且防止椎间空间在去除所述椎间盘的情况下的塌陷。通常，两个融合器9并排布置在单个椎间空间中。内芯91由多孔结构（在图11a中用交叉影线表示）形成，由此促进用于两个相邻椎骨的经改善融合的骨向内生长。芯91被由固体材料制成的外壳90环绕，从而充当用于向脊柱融合器9提供机械强度的加强元件。在外壳90的顶部和底部表面上，设置多个齿92。齿92被成形为像倾斜金字塔以用于使融合器止动在适当位置，由此防止任何不希望的错位。在图11b中显示融合器9'的变型。其被类似地构造为图11a中所示的变型，然而，其特征在于其侧面上的对称布置的凹口93，该凹口93充当插入器械（未显示）的联接构件。在图11c中显示融合器9''的另一变型。其类似于图11b的融合器，然而，另外特征在于外壳90的前部区段处的附接孔94。附接孔94被构造有内螺纹以用于到具有相反螺纹的保持器具（未显示）的固定附接。
为了制造骨植入物7, 8，可以优选的是：提供骨植入物的三维模型；限定骨植入物的本体；限定骨植入物7, 8的骨接触表面，其被构造成补充骨的对应表面，其中至少骨接触表面被制造为多孔结构。由此，骨植入物7, 8可以被建模成诸如匹配预期植入位置。这允许极精确制造。
该用于制造包括具有多孔结构并且具有被构造成用于装配到骨、优选地骨缺损中的尺寸和形状的本体的骨植入物的方法可以总结为：该方法包括通过使用沉积技术形成多孔结构来制造骨植入物7, 8：形成成形为像四足体5的基础元件的交替层；按大体平行取向在每一层中布置四足体5；相对于前一层的四足体5在每隔一层中旋转四足体5；形成其内部空间形成互连孔的规则布置的基本单元4，基本单元4由按层布置的基础元件限定。

Claims (25)

1.一种包括本体的骨植入物，所述本体具有多孔结构(3)并且具有被构造成用于装配到骨、优选地骨缺损中的尺寸和形状，
其特征在于，
所述多孔结构(3)包括规则布置的基本单元(4)，所述基本单元(4)的内部空间形成互连孔，
所述基本单元(4)由按层布置的基础元件形成，其中所述基础元件成形为像四足体(5,5')，每一层中的所述四足体(5)按平行取向布置并且被定位成相对于相邻层的四足体(5')在其层中旋转。
2. 根据权利要求1所述的骨植入物，其中，在所述层内，三个相邻四足体(5)在节点(55)中借助其腿部(52, 53, 54)中的一者相互连接，并且所述节点(55)限定所述层的基准平面(45)，并且所述四足体(5)的第四腿部(54)大体垂直于所述基准平面(45)取向。
3.根据权利要求2所述的骨植入物，其中，所述层的所述节点(55)直接定位在相邻上部层的所述四足体(5')的所述第四腿部(54')下方，以使所述第四腿部(54')直接在下方与所述节点(55)隔开。
4. 根据权利要求2或3所述的骨植入物，其中，所述四足体(5, 5')的所述腿部(51,52, 53, 54)取向为大体垂直所述基准平面(45)或倾斜但不平行于所述基准平面(45)。
5. 根据权利要求2至4中的任一项所述的骨植入物，其中，在节点中连接的所述腿部(52, 53, 54)与所述基准平面(45)之间的角度大于20°，优选地为从25°至35°。
6. 根据权利要求2至5中的任一项所述的骨植入物，其中，所述第四腿部(51)比所述其它腿部(52, 53, 54)短。
7. 根据前述权利要求中的任一项所述的骨植入物，其中，所述层交替移位以使一个层的所述四足体(5)相对于所述相邻层的所述四足体(5')旋转，优选地按具有旋转和不旋转四足体(5, 5')的层的交替布置。
8. 根据前述权利要求中的任一项所述的骨植入物，其中，所述四足体(5, 5')通过沉积和固化制成在适当位置、优选地在连续层中。
9. 根据前述权利要求中的任一项所述的骨植入物，其中，所述四足体(5, 5')通过电子束熔化(EBM)或选择性激光熔化(SLM)工艺获得。
10.根据前述权利要求中的任一项所述的骨植入物，其中，所述多孔结构由选自包括钛合金、纯钛、钴铬、钽、不锈钢和锆的群组的优选生物相容材料制成。
11.根据权利要求10所述的骨植入物，其中，所述材料为纯钛、优选地2级钛，或者钛合金、优选地Ti6Al4V。
12.根据前述权利要求中的任一项所述的骨植入物，其中，所述多孔结构设置有PVD涂层(30)，该涂层优选地选自包括铌、钽、锆及其氧化物的群组。
13.根据前述权利要求中的任一项所述的骨植入物，其中，所述多孔结构设置有磷酸钙涂层(30)。
14. 根据权利要求12或13所述的骨植入物，其中，所述涂层(30)的厚度被尺寸确定为在1 µm与10 µm之间，优选地小于7 µm。
15.根据前述权利要求中的任一项所述的骨植入物，其中，设置固体本体结构，所述多孔结构附接到固体本体结构，其优选地作为整体结构。
16.根据前述权利要求中的任一项所述的骨植入物，其中，其形状和尺寸被构造成诸如可用于髋臼或肱骨杯、骨增强装置，优选地髋臼、肱骨、股骨或胫骨(8)增强件或融合器(9)，优选地椎间融合器。
17.一种内用假体植入物，其包括由固体材料制成的本体和由多孔结构(3)制成的骨接触部分，
其特征在于，
所述多孔结构(3)包括规则布置的基本单元(4)，所述基本单元(4)的内部空间形成互连孔，
所述基本单元(4)由按层布置的基础元件形成，其中所述基础元件成形为像四足体(5,5')，每一层中的所述四足体(5)按平行取向布置并且被定位成相对于相邻层的所述四足体(5')在其层中旋转。
18.根据权利要求17所述的内用假体植入物，其中，所述本体是铰接关节的组件，优选地带有任选内衬的杯(6)。
19. 根据权利要求17所述的内用假体植入物，其中，所述本体是将所述多孔结构划分成两个不同区段(71, 72, 81, 82)的隔板元件(70, 80)，所述隔板元件(70, 80)优选地被构造成阻挡接合剂流过。
20.根据权利要求17至19中的任一项所述的内用假体植入物，其中，所述本体是加强元件(75)。
21.根据权利要求17或20所述的内用假体植入物，其中，所述本体形成脊柱融合器(9)并且被构造成环绕由所述多孔结构制成的芯(90)。
22.一种用于制造骨植入物的方法，所述骨植入物包括具有多孔结构并且具有被构造成用于装配到骨、优选地骨缺损中的尺寸和形状的本体，
其中所述方法包括通过使用沉积技术形成多孔结构来制造所述骨植入物：
- 形成成形为像四足体的基础元件的交替层，
- 按大体平行取向在每一层中布置所述四足体，
- 相对于其前一层的所述四足体在每隔一层中旋转所述四足体，
- 形成规则布置的基本单元，所述基本单元的内部空间形成互连孔，所述基本单元由按层布置的基础元件限定。
23.根据权利要求22所述的方法，其中，所述方法还包括以下步骤：
- 提供所述骨植入物的三维模型，
- 限定所述骨植入物的本体，
- 限定所述骨植入物的骨接触表面，其被构造成补充所述骨的对应表面，其中至少所述骨接触表面被制造为所述多孔结构。
24.根据权利要求22或23所述的方法，其还包括通过物理气相沉积(PVD)工艺在所述多孔结构上沉积涂层，优选地使用钽作为所述涂层。
25.根据权利要求22或23所述的方法，其还包括在所述多孔结构上沉积涂层，所述涂层是CaP涂层。
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