CN107847641A - 具有至少一个骨整合和骨诱导表面(多)层结构的金属和/或陶瓷组件 - Google Patents

具有至少一个骨整合和骨诱导表面(多)层结构的金属和/或陶瓷组件 Download PDF

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CN107847641A
CN107847641A CN201680044120.9A CN201680044120A CN107847641A CN 107847641 A CN107847641 A CN 107847641A CN 201680044120 A CN201680044120 A CN 201680044120A CN 107847641 A CN107847641 A CN 107847641A
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ceramic component
integrated implant
self
rotating fields
bone grafting
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A.A.波尔波拉蒂
M.拉施克
R.施特赖歇尔
M.孔茨
R.普罗伊斯
L.戈特维克
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Ceramtec GmbH
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Abstract

本发明涉及具有改进的骨整合和骨诱导性质的金属和/或陶瓷组件，特别是在医学技术领域。本发明还涉及用于生产陶瓷组件的方法。

Description

具有至少一个骨整合和骨诱导表面(多)层结构的金属和/或 陶瓷组件
本发明涉及具有改进的骨整合和骨诱导性质的金属和/或陶瓷组件，特别是在医学技术领域，所述金属和/或陶瓷组件适合于在人体(例如人骨盆的髋臼区)中进行无骨水泥固定。本发明还涉及生产金属和/或陶瓷组件的方法。
现今，对于在人骨盆的髋臼区中陶瓷插入物的无骨水泥固定，具有骨整合表面结构的金属外壳是必需的。直接固定陶瓷植入物至骨中的一种可能性描述于例如EP 1268364A1，其中陶瓷体被分层，其表面结构具有开孔。
然而，本发明的目标是进一步增强金属和/或陶瓷组件的骨整合性质，所述性质是促进骨向内生长的能力。
该目标通过本发明的金属和/或陶瓷组件得到解决，所述组件包含骨整合和骨诱导表面(多)层结构，其中根据权利要求1，表面(多)层结构的表面层包含铝酸锶。由于添加包含铝酸锶的多孔骨整合和骨诱导表面(多)层结构至陶瓷基底的背侧，还能够直接植入金属和/或陶瓷组件。
由于在金属和/或陶瓷组件的金属或陶瓷表面上的骨整合和骨诱导基层中存在铝酸锶，本发明的包含骨整合表面(多)层结构的金属和/或陶瓷组件能够增加骨生长速率。表面(多)层结构还可具有骨诱导性质，因此可促进成骨细胞的生长、成熟和活性。已知锶是一种骨形成剂。含锶的药物已经在各种临床背景下用作促进骨质疏松性骨的机械稳定性的系统性成骨细胞-活化药物，但尚未作为用于促进陶瓷组件(特别是植入物)的骨向内生长的活性成分进行描述。
本发明中使用的术语金属和/或陶瓷组件包含仅由金属或仅由或陶瓷材料构成的组件，还包含例如，主要由陶瓷构成并具有金属表面的组件。本发明的优选的金属和/或陶瓷组件是在医学技术领域中使用的陶瓷组件。
因为本发明的金属和/或陶瓷组件将用于医学技术领域，组件优选是植入物，例如髋关节成形术中的杯或用于脊骨的罩。
本发明的陶瓷组件在其表面上包含骨整合和骨诱导表面(多)层结构，所述结构包含至少一个骨整合和骨诱导层。骨整合表面结构优选地是多层结构和包含数个骨整合层，例如至多30层。优选地，骨整合表面(多)层结构包含1-5个骨整合层。
本发明的骨整合和骨诱导表面(多)层结构包含陶瓷基质材料和铝酸锶。术语铝酸锶包含任何已知的铝酸锶化合物，例如基础铝酸锶(SrAl2O4)、单斜晶铝酸锶(SrAl4O7)、立方铝酸锶(Sr3Al2O6)、六边形铝酸锶(六铝酸锶；SrAl12O19)和正交铝酸锶(Sr4Al14O25)。优选的化合物是六铝酸锶。铝酸锶优选地在骨整合表面(多)层结构内以小片形式存在。铝酸锶的含量范围可以是1 wt%-50 wt%，优选地1 wt%-20 wt%，基于表面(多)层结构的总重量计。
陶瓷基质材料选自氧化铝基陶瓷、氧化锆基陶瓷，优选地氧化铝基陶瓷和氧化锆基陶瓷，更优选地氧化锆-小片韧化的氧化铝陶瓷。在氧化锆-小片韧化的氧化铝陶瓷中氧化锆含量为至多25 wt%，基于表面(多)层结构的总重量计。
骨整合和骨诱导表面(多)层结构可通过在骨整合表面(多)层结构的不同层中的不同锶含量而显示锶梯度，其目的是逐渐释放在表面(多)层结构中的残余应力。在优选的实施方案中，锶含量随层数增加，其中第一/最内层具有最低的锶含量和最后/最外层具有最大的锶含量。最外层必须被视为与人体的周围组织或骨骼直接接触的层。
在各个锶梯度结构的最内层中铝酸锶的量为小于5 wt%，优选地等于或小于1wt%，基于表面(多)层结构的总重量计，前提条件是锶含量不是零。最外层包含小于25 wt%、优选地15-20 wt%的量的铝酸锶，基于表面(多)层结构的总重量计。
骨整合和骨诱导表面(多)层结构的孔隙率，其为每单位体积的孔数量，可以是25%-90%，优选地25%-70%。孔直径是1微米-1000微米，优选地20微米-600微米。每单位体积的孔数量、它们的大小(即，其直径)和其形状可有利地通过选择合适的孔形成物质来确定。
整个层的厚度是约0.02 mm-10 mm，优选地0.1 mm-2 mm。
为了生产具有骨整合和骨诱导表面多层结构的陶瓷组件，例如高度骨整合和骨诱导植入物，高含量锶氧化铝氧化锆基陶瓷浆液可通过使用描述于例如EP 1268364 A1的方法，沉积在生坯(green)基底上，其中基底作为生坯的无机材料体形成，和向生坯体状态的基底施加构成基底的所述无机材料的悬浮液或其它材料。该悬浮液包含层材料，另外可包含孔形成物质，或孔形成物质也可单独施加。仅在施加层后，通过干燥和烧结常规热处理基底和层，以产生整体模塑。生产基底的方法与现有技术已知的那些通常没有不同。
在烧结期间，生坯基底达到完全密度；另一方面，表面(多)层结构保持微孔(因为由高体积小片含量引起的较低的烧结活性)和大孔(因为孔形成剂或发泡剂)。微孔的直径为0.05微米-5微米，但优选地处于亚微米水平，0.1微米-1微米，而大孔具有1-100微米、优选地10-500微米的直径，前提条件是大孔的直径大于微孔。此外，必须理解，微孔应看起来像材料内的“洞穴”，而大孔像“谷”。
氧化铝基陶瓷浆液包含氧化铝、氧化锆、氧化锶和氧化钇。在烧结阶段期间，在氧化铝和氧化锶之间的固体反应经历形成铝酸锶，特别是六铝酸锶。
为了实现大孔骨整合和骨诱导表面(多)层结构，相应的陶瓷浆液还可包含(有机)添加剂，例如孔形成剂或发泡剂，这取决于形成多孔层的相应方法。这样的添加剂可以0.05-10 wt%的量存在，基于表面多层结构组合物的总重量计。尽管孔形成剂在烧结过程期间被热解，但发泡剂用于发泡过程，均产生具有上文公开的孔隙率的多孔骨整合和骨诱导层。
因此，孔隙率可分别在烧结过程中用有机孔形成剂，或用孔形成剂或发泡剂和发泡程序提高。
作为孔形成物质，特别使用有机化合物，例如淀粉、纤维素或蜡，和天然和合成的聚合物，其在热处理基底和其上沉积的层期间蒸发，气化以消耗或燃烧，从而形成孔。
陶瓷浆液可进一步包含通常用于陶瓷技术领域的添加剂，例如粘合剂。
或者，还有可能施加骨整合层到烧结状态的基底上。由此，通过蒸汽沉积或等离子体沉积过程，表面(多)层结构可沉积到烧结陶瓷基底或特别制备的金属基底上。
骨整合和骨诱导表面(多)层结构也可在预存在的大孔表面上生长，所述表面可能是陶瓷泡沫或金属骨整合表面。产生微孔和大孔，用于改进骨整合和骨诱导。
骨整合和骨诱导表面(多)层结构也可沉积在陶瓷组件的结构化表面上。在本发明的情况下，结构化表面是例如多孔表面。陶瓷组件表面的结构化可通过碾磨方法、车削方法或二者的组合产生。另一种生产结构化表面的方法是陶瓷注射模塑方法。金属或陶瓷组件表面的结构化可通过例如增材制造产生。
或者，在烧结期间热解的孔形成剂或用于发泡过程的发泡剂可添加至基底材料，以产生结构化表面。
生产结构化表面的其它方法是研磨或放电机械加工方法。

Claims (10)

1.陶瓷组件，该陶瓷组件在其表面上包含骨整合和骨诱导表面(多)层结构，所述结构包含至少一个骨整合层，其中骨整合和骨诱导层包含铝酸锶。
2.权利要求1的陶瓷组件，其中所述骨整合和骨诱导表面(多)层结构包含数个骨整合和骨诱导层。
3.权利要求1或2的陶瓷组件，其中所述铝酸锶以小片形式存在。
4.权利要求2的陶瓷组件，其中所述表面(多)层结构的骨整合和骨诱导层具有不同的锶含量。
5.权利要求4的陶瓷组件，其中所述锶含量随层数增加，使得最外层具有最高的锶含量。
6.权利要求1-5中任一项的陶瓷组件，其中陶瓷组件的表面被结构化。
7.权利要求6的陶瓷组件，其中所述表面的结构化通过选自以下的方法进行：碾磨方法、车削方法、碾磨和车削方法的组合、陶瓷注射模塑、由于添加发泡剂导致的发泡方法、在烧结期间由于添加孔形成剂导致的孔形成方法、研磨方法、放电机械加工和增材制造。
8.生产权利要求1-7中任一项的陶瓷组件的方法，其中包含铝酸锶的陶瓷浆液被施加至生坯(green)状态的基底。
9.生产权利要求1-7中任一项的陶瓷组件的方法，其中所述骨整合表面(多)层结构被施加至烧结状态的基底。
10.权利要求9的方法，其中所述骨整合表面(多)层结构通过蒸汽沉积或等离子体沉积施加。
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