CN106659571A - 带有多孔的面向骨骼的背侧面的全陶瓷的膝关节代替物 - Google Patents

带有多孔的面向骨骼的背侧面的全陶瓷的膝关节代替物 Download PDF

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Publication number
CN106659571A
CN106659571A CN201580037276.XA CN201580037276A CN106659571A CN 106659571 A CN106659571 A CN 106659571A CN 201580037276 A CN201580037276 A CN 201580037276A CN 106659571 A CN106659571 A CN 106659571A
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China
Prior art keywords
porous
knee joint
bone
joint replacement
dorsal surface
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CN201580037276.XA
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English (en)
Inventor
R.普罗伊斯
M.拉施克
P.施特勒特根
T.魏斯
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Ceramtec GmbH
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Ceramtec GmbH
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Publication of CN106659571A publication Critical patent/CN106659571A/zh
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  • Health & Medical Sciences (AREA)
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  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)
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Abstract

本发明涉及膝关节代替物，具有股骨部件（1）和胫骨部件（2）以及具有聚乙烯衬垫、即PE衬垫（3），所述股骨部件和所述胫骨部件分别具有形成关节的前侧面和面向骨骼的背侧面（4）。为了能够无金属地并且没有粘固剂地植入所述膝关节代替物而提出，所述股骨部件（1）和所述胫骨部件（2）由全陶瓷制成并且带有这两个部件（1、2）的集成的多孔的骨能够结合的面向骨骼的背侧面（4）。

Description

带有多孔的面向骨骼的背侧面的全陶瓷的膝关节代替物
技术领域
本发明涉及膝关节代替物，所述膝关节代替物具有股骨部件和胫骨部件以及具有聚乙烯（PE）衬垫，所述股骨部件和所述胫骨部件分别具有形成关节的前侧面和面向骨骼的背侧面。
背景技术
当前的临床的现有技术为膝关节的代替物规定到超过90%粘固的内假体。骨骼粘固剂最初非常好地粘附在金属的内假体（CoCrMo合金或Ti合金）的非常粗糙的表面处，但经过时间由于在人体中的含水的环境的作用而与部件脱离（所谓的“Debonding”）。由于膝内假体在所述骨骼粘固剂套（Knochenzementköcher）和由于所述关节的动态的负荷所引起的所述、骨骼粘固剂向前推进的亚临界的裂纹生长上的微运动，使得所述骨骼粘固剂随着时间经过而毁坏。磨损颗粒产生，所述磨损颗粒一方面到达到周围的组织中，另一方面还能够游移到所述关节的滑动面中并且在该处让所述聚乙烯（PE）衬垫加强地磨损。所产生的骨骼粘固剂磨损还有PE磨损大多导致所述周围的组织的生物反应。后果是局部的发炎和骨质溶解（骨骼的萎缩），其又会导致植入物的无菌的松开。这种机理对于粘固的膝内假体是不可避免的并且还解释了，为什么粘固的膝关节内假体的平均的使用寿命处在仅仅10至20年。
对于较长的假体寿命具有大的潜力的一种备选方案呈现为无粘固剂的膝内假体。如今在市面上建立的是金属的膝关节内假体，其常常设有同样金属的骨能够结合的涂层，所述涂层实现所述骨骼直接长入到植入物表面中。通过所述骨骼直接生长（Anwachsen）并且长入到所述植入物表面处来保证在植入物和骨骼之间的长时间稳定的结合并且所述假体的寿命能够相对于粘固的变型方案强烈地得到提高（直到30年）。无粘固剂的金属的内假体经受比利用陶瓷的变型方案的情况下的磨损高的磨损。另外的大的缺点是金属本身的使用，因为在当前越来越多的人对于所使用的金属发展出不相容性并且金属的关节代替物不适用于过敏者。
发明内容
根据本发明地应用能够直接植入的带有集成的多孔的骨能够结合（osseointegrativen）的面向骨骼的背侧面的全陶瓷的膝关节部件（股骨部件和胫骨部件，在整个膝系统中与PE衬垫组合）呈现为有利的创新。
这样的无金属的膝关节部件将生物兼容的、过敏者适用的材料的和滑动配对的小的磨损的优点与突出的骨能够结合性统一。
作为现有技术提及EP 0 542 815 B1以及EP 1 268 364 A1。
根据本发明的膝关节代替物（所述膝关节代替物具有股骨部件和胫骨部件以及具有聚乙烯（PE）衬垫，所述股骨部件和所述胫骨部件分别带有形成关节的前侧面和面向骨骼的背侧面）的特征在于，所述股骨部件和所述胫骨部件由全陶瓷制成并且带有两个部件的多孔的骨能够结合的面向骨骼的背侧面。
在一种根据本发明的设计方案中，所述股骨部件和所述胫骨部件分别由陶瓷的烧结模制体制成，其中，所述烧结模制体在其面向骨骼的背侧面上具有多孔的覆层。
在另一根据本发明的设计方案中，所述多孔的面向骨骼的背侧面通过在生坯状态中施加陶瓷的浆料以及占位件（孔形成器（Porenbildner））在基体（部件）上（Platzhaltern）产生。通过烧结过程实现所述覆层与所述基体的结合。通过在烧结时烧尽所述占位件来产生具有裂缝的表面的开孔的结构，其有利地支持所述骨骼的生长和长入。对此还参见EP 1 268 364 A1。
所述陶瓷的浆料由与陶瓷的基体相同的材料制成。完整的植入物由此包括涂层在内完整地没有金属并且关于过敏反应是有利的。
在另一根据本发明的设计方案中，所述多孔的面向骨骼的背侧面通过在所述生坯状态中在所述基体（部件）上陶瓷的浆料以及占位件（孔形成器）的起泡来产生。通过烧结过程来实现所述覆层与所述基体的结合并且产生带有裂缝的表面的开孔的结构，其有利地支持所述骨骼的生长和长入。这种结合陶瓷的基体的涂层的类型同样无金属地关于过敏反应是有利的。
所述多孔的面向骨骼的背侧面也能够通过在烧结的状态中将密实的模制体与多孔的陶瓷的模制体接合来产生。所述多孔的模制体能够通过陶瓷的浆料的起泡以及烧结来产生或者通过将多孔的基底材料渗入有浆料并且烧结来产生。所述接合优选地通过焊接或粘结实施。这种结合陶瓷的基体的涂层的类型无金属地关于过敏反应是有利的。
所述集成的多孔的骨能够结合的面向骨骼的背侧面根据本发明也能够通过双色注塑（密实的阶段和多孔的或形成孔的阶段）以及烧结来产生。这种结合陶瓷的基体的涂层的类型是无金属的。
所述多孔的面向骨骼的背侧面能够优选地通过另外的涂层来获得附加的功能性、如更高的结合速度或抗菌的作用。结合速度被理解成以所述骨骼来长入的时间。优选地这能够利用生物玻璃、羟基磷灰石、功能蛋白或水凝胶来实现。
在另一根据本发明的设计方案中，所述多孔的面向骨骼的背侧面通过在已经烧结的陶瓷基体上施加多孔的金属的生物兼容的覆层来产生（参见EP 1 052 949 B1）。
附图说明
图1示出在植入的状态中的完全陶瓷的膝关节内假体，由股骨部件1、胫骨部件2和处于之间的聚乙烯（PE）衬垫3构成。所述多孔的面向骨骼的背侧面利用附图标记4来表示。

Claims (11)

1.膝关节代替物，具有股骨部件（1）和胫骨部件（2）以及具有聚乙烯衬垫、即PE衬垫（3），所述股骨部件和所述胫骨部件分别具有形成关节的前侧面和面向骨骼的背侧面（4），其特征在于，所述股骨部件（1）和所述胫骨部件（2）由全陶瓷制成并且具有两个部件（1、2）的集成的多孔的骨能够结合的面向骨骼的背侧面（4）。
2.根据权利要求1所述的膝关节代替物，其特征在于，所述股骨部件（1）和所述胫骨部件（2）分别由陶瓷的烧结模制体制成。
3.根据权利要求2所述的膝关节代替物，其特征在于，所述烧结模制体在其背侧面上具有多孔的覆层（4）。
4.根据权利要求1所述的膝关节代替物，其特征在于，所述多孔的背侧面（4）通过在生坯状态中施加陶瓷的浆料以及占位件（孔形成器）以及在烧结时烧尽所述占位件产生。
5.根据权利要求1所述的膝关节代替物，其特征在于，所述多孔的覆层（4）通过在所述生坯状态中陶瓷的浆料起泡以及接下来的烧结产生。
6.根据权利要求1所述的膝关节代替物，其特征在于，所述多孔的背侧面（4）通过在烧结的状态中将密实的模制体与多孔的陶瓷的模制体接合产生。
7.根据权利要求6所述的膝关节代替物，其特征在于，所述多孔的模制体通过陶瓷的浆料起泡以及烧结产生或者通过将多孔的基底材料渗入有浆料并且烧结产生。
8.根据权利要求6或7所述的膝关节代替物，其特征在于，所述接合通过焊接或粘结实施。
9.根据权利要求1所述的膝关节代替物，其特征在于，所述集成的多孔的骨能够结合的背侧面（4）通过双色注塑（密实的阶段和多孔的或形成孔的阶段）以及烧结产生。
10.根据权利要求1至9中任一项所述的膝关节代替物，其特征在于，所述多孔的背侧面（4）通过另外的涂层来获得附加的功能性、如更高的结合速度或抗菌的作用。
11.根据权利要求10所述的膝关节代替物，其特征在于，所述多孔的背侧面（4）以生物玻璃、羟基磷灰石、功能蛋白或水凝胶来涂层。
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