CN101237834B - 多孔植入体 - Google Patents

多孔植入体 Download PDF

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CN101237834B
CN101237834B CN2005800512672A CN200580051267A CN101237834B CN 101237834 B CN101237834 B CN 101237834B CN 2005800512672 A CN2005800512672 A CN 2005800512672A CN 200580051267 A CN200580051267 A CN 200580051267A CN 101237834 B CN101237834 B CN 101237834B
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implant
embedded body
implant according
mean porosities
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CN101237834A (zh
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T·伊姆文克尔里德
L·吉热
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AO Technology AG
Synthes GmbH
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Synthes AG Chur
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    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61C8/0012—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy
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Abstract

一种具有成形体的植入体(1)，其中A)所述成形体具有平均孔隙率为P2的第一区域(2)和平均孔隙率为P3的第二区域(3)，其中P3＜P2；和B)具有较低平均孔隙率P3的所述第二区域(3)被设计为用于处理或固定所述植入体(1)。

Description

多孔植入体
技术领域
本发明涉及一种具有成形体的植入体。
这种植入体特别用于外伤外科领域，可作为脊柱植入体或作为上颌面植入体。
背景技术
为了处理这种植入体并且将它们锚固到骨头上，可在所述植入体的烧结体中应用埋头螺纹孔。然而，由于所述烧结体的高表面粗糙度，器械的操作和固定装置例如固定螺钉的引入，可产生来自所述植入体的颗粒磨损。
发明内容
本发明的目的是提供一种稳定地机械连接到多孔植入体上并且避免在处理和/或固定所述植入体的过程中产生上述颗粒磨损的装置。
本发明通过具有如下特征的植入体解决所提出的问题：
所述植入体具有成形体；
所述成形体具有平均孔隙率为P2的第一区域和平均孔隙率为P3的第二区域，其中P3＜P2；
具有较低平均孔隙率P3的所述第二区域被设计为用于处理或固定所述植入体；
所述第一区域包括与所述第二区域不同的材料。
由于所述植入体的第二区域比所述植入体的第一区域具有更低的平均孔隙率，因此在植入体的处理或固定过程中可避免烧结材料的颗粒磨损。
在冶金和陶瓷技术中，已知多种生产具有相互连接孔的成形体的方法。成形烧结体的典型的制造方法在如下的文献中被公开：
泡沫钛：例如DE-A 196 38 927，WO 03/101647 A2和WO01/19556，这些文件的内容被结合在本申请中。
多孔镍钛合金：美国专利US 5,986,169
多孔钽：美国专利US 5,282,861，EP 0 560 279
植入体的多孔金属和金属覆层：WO 02/066693
为了获得用于例如通过接骨螺钉固定或通过器械操作所述植入体的适当的表面结构，由完全致密的材料例如钛制成的嵌入体(inlay)可埋入到所述植入体的相应的孔中。所述钛嵌入体可具有可与处理所述植入体或可接收固定所述植入体的固定装置的工具相互配合的装置，例如腔，从而这些装置允许存在高几何公差，以确保工具或固定装置的接合，并且不会导致在操作或固定过程中钛颗粒磨损。在实施所述烧结工艺之前，所述嵌入体和所述“生坯”状态的泡沫钛被结合起来。此外，所述嵌入体可插入到所述生坯体中的钻孔中，从而所述嵌入体可在所述钻孔中具有间隙或可宽松地连接到所述生坯体上。由于泡沫钛在烧结过程中的收缩，所述嵌入体可强力地被夹在烧结后状态下的所述植入体中。
在嵌入体以一定的间隙插入钻孔的情况下通过重力，或者通过与生坯体的所述钻孔的壁相接触的所述嵌入体的外表面上的小突起的宽松座，所述嵌入体可在烧结过程中保持在所述钻孔中。
可选择地，通过使用坚固并且具有延展性的材料例如钛，所述植入体的第一区域的泡沫结构的孔壁可在传统的机加工(例如车、铣等)过程中会“抹平(smeared)”。所述抹平效果可用于在固定交界面上获得更光滑的表面，例如获得能够与处理所述植入体或接收用于固定所述植入体的固定装置的工具相互配合的装置。这种装置优选地构造有内螺纹。然而，在所述烧结过程之后被机加工的、具有多孔结构的植入体是难于清洁的。这种由于机加工造成的污染和抹平效果可通过可选的工艺，例如EDM(放电加工)线或水喷射切割来避免。这两种工艺都可在所述表面上保持多孔开放的结构。
在优选的实施例中，所述成形体的第一区域包括与第二区域相同的材料。通过成形体中的孔隙率梯度，所述成形体的第二区域是可制造的，从而在所述植入体的处理和固定过程中，可以避免颗粒的磨损。
在另一个实施例中，所述成形体的第一区域包括与第二区域不同的材料。因此可实现下述优点：所述成形体的第二区域可选用较低孔隙率的材料，从而在所述植入体的处理或固定过程中可避免颗粒的磨损。
在另一个实施例中，平均孔隙率P3＜P2中的至少一个具有梯度。
在另一个实施例中，所述成形体的第一区域的平均孔隙率P2处于30-90％的范围内，优选地为50-70％。位于所述范围内的平均孔隙率的优点为能够实现机械特性和骨向内生长的最大可能的孔隙率的最优组合。
优选地，所述成形体的第二区域的平均孔隙率P3低于10％，优选地低于2％。其优点为该孔隙率可获得不产生任何磨损颗粒的最优化的光滑表面。
在另一个实施例中，所述第二区域是在烧结过程之前可以与所述第一区域结合的嵌入体的形式。在烧结过程之后，由于烧结的第一区域的收缩，所述嵌入体可被强力地夹住。
在另一个实施例中，所述第二区域具有可与处理所述植入体或接收固定所述植入体的固定装置的工具配合的装置。
在另一个实施例中，所述成形体的第一区域包括无机材料，优选地为金属或陶瓷材料。所述无机材料可从生物相容的金属或烧结陶瓷构成的组中选择，优选地为可生物相容的钢、钛和钛合金、钽和钽合金、生物相容的镍钛合金、镁和镁合金。
在另一个实施例中，所述第一区域包括开放多孔的、具有相互连接的孔隙的金属泡沫。优选地，所述金属泡沫由粉末冶金工艺或涂覆工艺或通过燃烧合成或通过其它已知的泡沫生产方法制造。
在另一个实施例中，所述成形体的第一区域包括通过使用生产生压坯和随后的多孔烧结体的添加造孔剂技术的粉末冶金方法获得的材料。
在另一个实施例中，所述成形体的第二区域包括可生物相容的金属或金属合金，优选地为钛、钢、钽、生物相容的镍钛合金。
在另一个实施例中，所述成形体的第二区域相对于所述第一区域具有较小的表面粗糙度。
在另一个实施例中，所述成形体的第二区域相对于所述第一区域具有更高的密度。
生产根据本发明的植入体的第一方法包括如下步骤：在所述净形植入体的烧结之前，将包括具有所述平均孔隙率P3的材料的嵌入体放置到包括具有所述平均孔隙率P2的材料的生压坯的开口中，从而所述插入体为净形。
在所述方法的优选实施例中，所述嵌入体被宽松地放置到所述生压坯的开口中，并且其中所述嵌入体站立在所述生坯体的表面上。
在所述方法的另一个实施例中，嵌入体被设置在所述生压坯的开口内侧，与该压坯的数个壁相接触，并且其中所述嵌入体主要通过摩擦力而保持住。
制造的据本发明的植入体的第二方法包括如下步骤：在所述第一区域的烧结之后，通过用力或使用热膨胀差异，将包括具有所述平均孔隙率P3的材料的嵌入体放置到所述植入体的第一区域的孔中。
附图说明
本发明和本发明的额外构造将参照数个实施例的局部示意图以更详细的方式加以解释。
图1示出了根据本发明的成形的植入体的实施例的透视图；
图2示出了处于生坯状态的图1中所示的成形的植入体的实施例的顶视图；
图3示出了处于烧结之后的最终状态的图1和图2中所示的成形的植入体的实施例的顶视图；
图4示出了处于生坯状态的根据本发明的成形的植入体的另一个实施例的截面图；
图5示出了处于最终状态的具有固定螺钉的在图4中所示的成形的植入体的实施例的截面图；
图6示出了根据图4和5中所示实施例的嵌入体的前视图。
具体实施方式
下面的例子将进一步解释根据本发明的植入体及其制造方法。
例1(具有通过净形(net-shape)烧结获得的嵌入体的植入体)“生坯”状态的泡沫钛8形式的植入体的第一区域2和钛嵌入体形式的由完全致密的材料制成的植入体的第二区域3在烧结过程之前结合在一起(图2)。如图2所示，嵌入体形式的第二区域3宽松地设置在“生坯”状态的泡沫钛8的埋头钻孔7中。
所述第二区域3，即所述嵌入体，包括与用于处理所述植入体或用于接收将所述植入体1固定在骨头上的固定装置的工具相配合的装置4(图1)。为了避免在操作和/或固定植入体1的过程中产生颗粒磨损，所述第二区域即嵌入体的材料的平均孔隙率P3(例如低于10％)比周围的生坯体的平均孔隙率(例如30-90％之间)低。嵌入体形式的第二区域3与第一区域2之间以机械上稳定的方式连接是通过将所述第一区域2与所结合的第二区域3即所述嵌入体烧结在一起实现的。由于“生坯”状态泡沫钛8形式的第一区域2在烧结过程中的收缩，所述第二区域3即所述嵌入体可被所述烧结的第一区域2强力地夹住(图3)。
例2(具有通过烧结后处理获得的嵌入体的植入体)
可选择地，通过用力(机械方式)或通过使所述第一区域2收缩到所述第二区域3即嵌入体上的方式，将完全致密的固定嵌入体形式的第二区域3插入到所述烧结的第一区域2的泡沫结构中。在烧结所述第一区域2之后，通过机械方式的压力配合或通过利用两个区域2、3之间的热膨胀差异(即加热外部的第一区域2和/或冷却收缩所述第二区域3即所述嵌入体)将所述第二区域3即所述嵌入体插入到烧结的第一区域2中的埋头钻孔7(图2)中。为了避免颗粒磨损，所述第二区域3的材料优选地具有低于10％的孔隙率，而周围的第一区域2的材料优选地具有介于30％至90％之间的孔隙率。
例3(具有在生坯状态过程中通过重力保持就位的嵌入体)
图1至3示出了空心的第二区域3即嵌入体，其具有内螺纹15(图1)并且在泡沫钛形式的第一区域2的增强层9内由钛合金(TAN)制成，从而所述增强层9具有10-20％的孔隙率。第二区域3即嵌入体用作拧入植入体1的内螺纹15中的植入体保持器(未示出)的交界面。
在烧结之前，手工地将所述带有螺纹的第二区域3即嵌入体放置到“生坯”状态的泡沫钛8形式的直立的第一区域2的埋头钻孔7中(图2)。在图2和3的实施例的情况下，在第二区域3即所述嵌入体的外壁11与埋头钻孔7的壁12之间存在一间隙“s”，在烧结过程中，所述第二区域3即嵌入体通过重力作用而被保持在其位置上。在烧结过程中，增强层9(10-20％的孔隙率)收缩约10％并且结合到所述第二区域3即所述嵌入体(孔隙率低于10％)上。
例4(具有在生坯状态下通过摩擦力保持就位的嵌入体的植入体)
在图4-6的实施例中，第二区域3即所述嵌入体的外壁11具有与所述第二区域3即所述嵌入体的中心轴6同心地布置的两个六边形环形式的小突起13。腔5的直径d稍微小于或等于横跨所述六边形环的边缘14的宽度，从而在烧结过程之前，所述第二区域3即所述嵌入体宽松地连接到“生坯”状态的泡沫钛8上。此外，在烧结过程之后，所述六边形环使得在所述第二区域3即所述嵌入体与所述第一区域2之间具有轴向的和旋转方向的正配合。接骨螺钉10可旋拧进入所述第二区域3即所述嵌入体的腔5中的内螺纹15中。在外科手术过程中，通过所述接骨螺钉10，所述植入体1可刚性地固定在骨头中。
所述带螺纹的第二区域3即所述嵌入体优选地由孔隙率低于10％的商业纯钛制成。在烧结过程中，孔隙率约60％的“生坯”状态的泡沫钛8(图4)在两个方向上都收缩约15％，并且最终以实体(solid)连接的方式包围着所述第二区域3即所述嵌入体。

Claims (16)

1.一种具有成形体的植入体(1)，其特征在于，
A)所述成形体具有平均孔隙率为P2的第一区域(2)和平均孔隙率为P3的第二区域(3)，其中P3＜P2；和
B)具有较低平均孔隙率P3的所述第二区域(3)被设计为用于处理或固定所述植入体(1)，
所述第一区域(2)包括与所述第二区域(3)不同的材料，并且所述第二区域(3)为嵌入体的形式。
2.根据权利要求1所述的植入体(1)，其特征在于，所述平均孔隙率P2处于30-90％的范围内。
3.根据权利要求1所述的植入体(1)，其特征在于，所述平均孔隙率P3低于10％。
4.根据权利要求1所述的植入体(1)，其特征在于，所述第二区域(3)具有可与用于处理所述植入体(1)或接收用于固定所述植入体(1)的固定装置的工具相配合的装置(4)。
5.根据权利要求1所述的植入体(1)，其特征在于，所述第一区域(2)包括无机材料。
6.根据权利要求5所述的植入体(1)，其特征在于，所述无机材料选自由可生物相容的金属或烧结陶瓷构成的组。
7.根据权利要求1所述的植入体(1)，其特征在于，所述第一区域(2)包括具有相互连接孔的开孔金属泡沫。
8.根据权利要求7所述的植入体(1)，其特征在于，所述金属泡沫通过粉末冶金工艺或通过涂覆工艺或通过燃烧合成或通过其它已知的泡沫生产工艺制成。
9.根据权利要求1所述的植入体(1)，其特征在于，所述第一区域(2)包括通过使用添加造孔剂技术的粉末冶金工艺获得的材料，以生产生压坯和随后的多孔烧结体。
10.根据权利要求1所述的植入体(1)，其特征在于，所述第二区域(3)包括可生物相容的金属或金属合金。
11.根据权利要求1所述的植入体(1)，其特征在于，所述第二区域(3)与所述第一区域(2)相比具有较小的表面粗糙度。
12.根据权利要求1所述的植入体(1)，其特征在于，所述第二区域(3)与所述第一区域(2)相比具有更高的密度。
13.一种生产权利要求1-12中任一项所述的植入体(1)的方法，其特征在于，在所述植入体烧结之前，将包括具有所述平均孔隙率P3的材料的嵌入体放置到包括具有所述平均孔隙率P2的材料的生压坯的开口中，从而所述植入体为净形。
14.根据权利要求13所述的方法，其特征在于，所述嵌入体宽松地放置到所述生压坯的开口中，并且所述嵌入体站立在所述生压坯的表面上。
15.根据权利要求13所述的方法，其特征在于，所述嵌入体以接触所述生压坯的数个壁的方式放置在所述生压坯的所述开口中，并且所述嵌入体主要通过摩擦力保持。
16.一种生产权利要求1-12中任一项所述的植入体(1)的方法，其特征在于，在烧结所述第一区域(2)之后，通过用力或使用热膨胀差异，将包括具有所述平均孔隙率P3的材料的嵌入体放置到所述植入体的第一区域(2)的孔中。
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JP2009504207A (ja) 2009-02-05
US20080215098A1 (en) 2008-09-04
KR101226779B1 (ko) 2013-01-25
KR20080042075A (ko) 2008-05-14
CN101237834A (zh) 2008-08-06
CA2618771C (en) 2015-03-24
TW200706189A (en) 2007-02-16
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EP1912596A1 (en) 2008-04-23
TWI421105B (zh) 2014-01-01

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