CN1638820A - 用于假体装置的就地氧化织构表面及其制备方法 - Google Patents
用于假体装置的就地氧化织构表面及其制备方法 Download PDFInfo
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- CN1638820A CN1638820A CNA028242173A CN02824217A CN1638820A CN 1638820 A CN1638820 A CN 1638820A CN A028242173 A CNA028242173 A CN A028242173A CN 02824217 A CN02824217 A CN 02824217A CN 1638820 A CN1638820 A CN 1638820A
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- prosthese
- blindage
- diffusion
- hardened
- oxide layer
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Abstract
一种在金属材料上的织构表面和氧化层涂层,它是通过化学和/或电化学侵蚀表面将表面织构改性的步骤和就地氧化步骤实现的。由于氧化层所赋予的抗蚀性和抗磨性以及表面织构所赋予的促进植入物到骨上的接合的能力,该表面对于制造假体装置特别是医学植入物非常有用。
Description
相关申请交叉引用
本申请要求2001年12月6日提交的美国临时专利申请US60/338,420的优先权。
技术领域
本发明总的来说涉及矫形植入物领域。具体来说,涉及具有涂有致密高耐磨性扩散硬化氧化层薄涂层的织构改性表面的矫形植入物。优选,织构改性是通过化学或电化学侵蚀来实现的,且金属植入物含有锆,表面层含有氧化锆。该表面涂层具有增强的促进骨骼长入的能力。本发明还涉及制备具有织构改性表面的金属矫形植入物的方法。
发明背景
矫形植入物材料必须兼备高强度、耐腐蚀性和组织兼容性。特别是当植入物的受者相对较年轻时,植入物的寿命是最重要的,因为植入物最好能够在病人的整个一生中都起作用。由于某些金属合金具有所需的机械强度和生物适应性,它们是制造假体的理想选择。这些合金包括316L不锈钢、铬-钴-钼合金和近来的已经被证明是制造承载假体的最佳材料的钛合金。
此外还发现金属假体在身体内并不是完全惰性的。体液作用于金属,导致它们被离子化过程慢慢腐蚀从而向体内释放金属离子。从假体释放的金属离子还跟承载表面的磨损速度有关,这是因为形成在表面上的钝化氧化膜被不断地除去:离子化过程中再钝化过程不断地释放金属离子。此外,第三者磨损(粘结剂或骨碎片)的存在会加速此过程,而且磨细的金属微粒会增大摩擦。
锆的杰出耐腐蚀性已经为人们所知多年。锆在许多水性介质或非水性介质中都显示了杰出的耐腐蚀性,因此在化学加工工业和在医学应用中的使用已经增多。对锆在这些领域的广泛应用的一个限制是它的抗磨性相对较低,易磨损。这种抗磨性低和易磨损也体现在锆合金中。
Watson的美国专利US2,987,352最先公开了一种制备带特定形态的氧化锆作表面层的锆承载物的方法。Watson的方法被Haygarth加以改进(US4,671,824),结果获得了改进的抗磨性和对氧化产物的更好的尺寸控制。Davidson的美国专利(5,037,438;5,152,794;5,180,394;5,370,694;5,372,660;5,496,359和5,549,667)表明,通过在假体装置的锆和锆合金基体上使用特定形态的氧化锆,可以获得许多好处。其中包括增强的强度、低摩擦和高耐磨性。Davidson的美国专利US5,037,438最先公开了一种制备具有氧化锆表面的锆合金假体的方法。Watson和Davidson的研究使人们认识到了一种具有陶瓷材料的所有优点且同时保留了金属表面的强度的特定形态的氧化锆。氧化的特征在于游离氧扩散入金属的表面;产生的氧化层的特征在于游离氧扩散入金属的表面。结果形成的“扩散硬化”材料具有陶瓷和金属的优越性能的独特组合,同时将这些材料的缺陷减到了最小。所有上面引用的Davidson、Watson和Haygarth的美国专利都在此引入作为参考,如同在此完全阐述。不过Davidson的早期研究集中在纯锆和以锆为主要金属的锆合金上,后来的研究表明要形成所需的扩散硬化氧化物这并不是必须的。例如,一种74wt%钛、13wt%铌和13wt%锆的合金(″Ti-13-13″)可以形成本文所用的扩散硬化氧化层。在Davidson等人的美国专利US5,169,567中公开了Ti-13-13。
医用植入物的另一个重要性能标准是固定稳定度。这一般是通过周围组织长入植入物,以及植入物以很大的剪切强度逐渐牢牢锚定到其它部件如骨粘结剂上的能力来实现的。典型的髋关节假体包括固定入股骨的柄、股骨头和连接股骨头的髋臼。典型的膝关节假体具有股节和胫节部分,两者都固定到相应的骨上。这是植入物固定就位的稳定性。这种固定可是固定在骨上或其它组织上,或者可以由,至少部分由例如骨粘结剂等材料构成。Davidson是通过在假体中使用多孔金属珠或金属丝网涂层来促进骨的长入和增强粘附到其它材料的表面积来实现假体的固定稳定性的。这些方法在Davidson的美国专利US5,037,438和其它专利中有记述,而且当结合氧化锆的优点时,代表了在许多领域内医用植入物的性能的改善。然而,对所述植入物的固定稳定性的改善需要继续。
在假体植入物领域的一个首要目标就是延长植入物的使用寿命,以避免或最小化对外科手术修正或更换的需要。人们希望延迟或完全防止植入物的损坏。引起植入物损坏的原因有很多。普遍认为植入物损坏要归因于身体对骨粘结剂的排斥。还认为对骨粘结剂的排斥并不是主要问题,主要问题在于由于骨粘结剂的物理特性,它不是一个作为关节植入物的一部分的合适结构部件。
具体地说,自然骨的弹性模量最高达约4×106p.s.i。植入物用的金属的弹性模量通常在15-35×106p.s.I左右。而聚甲基丙烯酸甲酯(PMMA)粘结剂的弹性模量在0.3-0.5×106p.s.i左右。因此PMMA粘结剂的刚度小于金属假体或周围骨。粘结剂的机械性能强度和疲劳强度性能比金属或骨低。这些相对的物理性能被认为是使用骨粘结剂的髋和膝假体植入物的损坏的根源。
植入假体也可以不用粘结剂。这些假体是通过骨或组织长入假体,或将假体楔入骨来实现固定的。这些假体还可以包括能增强纤维组织或骨的长入的表面特性。这些表面特性可通过沉积或喷涂的方法来施加。
通常认为表面粗糙化会增大表面积,它通常会使两个表面的固定具有更好的粘着性。尽管光滑表面能使植入物内部的应力最小化,但它也会使总表面积最小化。减少的表面积显著降低了植入物对骨和组织的附着强度,此附着强度主要依赖于植入物和组织的机械相互作用。此机械相互作用有两种形式。一种形式是结合到组织生长到植入物的一部分的后面或周围的程度。另一种是摩擦形式,其中组织长成与植入物表面非常近似的形式从而获得相对紧密的磨擦配合。
Wagner等人在US5,922,029中公开了一种方法,使用电化学侵蚀方法生成能促进骨组织的长入并能促进附着表面向另一种材料的接合的具有随机的不规则图案的附着表面(所得产品公开于US6,193,762)。Wagner等人教导了其中使用的蚀刻方法是纯化学方法的类似方法(US5,258,098)和医学植入物产品(US5,507,815)。尽管Wagner等人的方法代表了表面织构改性方法的一种可能来源,但是可以预料,任何其它表面织构改性方法对于辅助固定同样有用。例如,可以将其中Frey(US4,272,855)、Van Kampen(US4,673,409)、Sump(US4,644,942)和Noiles(US4,865,603)的教导与Davidson的就地扩散硬化表面氧化相结合,制备出具有出众的表面氧化性质以及由宏观的织构改性而产生的稳定性和向内生长增强的优点的假体表面。
存在着对制备具有改进的固定性,且同时保持或改进了通过使用氧化锆而获得的进步的医学植入物的方法的需要。改进的稳定性对于植入物与骨和周围组织的接触面,以及植入物与其它材料如骨粘结剂的接触面都是需要的。这些应该可以通过同时保持由使用就地氧化扩散硬化表面如氧化锆而获得的优点来达到。
发明概述
本发明涉及一种基体材料上的织构化表面和氧化层涂层,以及具有上述织构化表面和氧化层涂层的假体装置。
本发明的一个方面,涉及一种在金属基体上制备改性表面的方法,包括将所述金属基体的表面的至少一部分的织构改性,以及将所述金属基体的表面的至少一部分氧化以在所述金属基体上形成扩散硬化表面的步骤。
以下是本发明的方法的具体实施方案,可以单独使用也可以与其它实施方案结合使用。
在其它方法实施方案中,改性步骤的特征可在于化学或电化学侵蚀。侵蚀的特征可在于用酸侵蚀。侵蚀的特征可在于向金属基体的表面进一步施加掩体的步骤。所述掩体可以随机地施加。掩体可以通过喷涂或溅射而施加在上述金属基体的所述表面上。所述喷涂或溅射的特征可在于掩体的随机施加。可以通过用掩体完全覆盖住表面然后部分地除去一部分掩体来将掩体施加到金属基体表面。部分除去掩体的步骤特征可在于用激光烧蚀部分所述掩体的步骤。
在其它方法实施方案中,部分除去掩体的步骤特征可在于以机械方式除去部分所述掩体的步骤。所述表面可以通过机械侵蚀改性。所述表面可以通过在上面沉积材料进行改性。所述沉积的特征可在于化学气相淀积。
在其它方法实施方案中,氧化金属基体至少一部分表面的步骤特征可在于空气、蒸汽或水氧化过程。氧化金属基体至少一部分表面的步骤特征可在于使用氧气作氧化剂。或者,氧化方法中包括使用盐浴。
在另一个实施方案中,金属表面是锆或一种锆合金。在该方法的一个特定实施方案中,锆合金选自具有高至约4.5wt%的铪和高至约3.0wt%的铌的锆合金;具有高至约4.5wt%的铪的锆合金;具有2.5-2.8wt%的铌的锆合金;和具有约13wt%铌和约13wt%锆的钛合金。
金属表面可以包含选自铪、铌、钽和钛的一种金属。
在本发明的另一个实施方案中,有一种植入假体包括第一假体部分和第二假体部分;所述第一假体部分包括一个承截面,所述承截面作成与所述第二假体部分上的第二承截面相接合或相配合的大小和形状;且其中所述第一假体部分或第二假体部分或两者的至少部分表面是通过如上所述的任何方法进行过织构改性的,且其中所述第一假体部分或第二假体部分或两者的至少部分表面包括扩散硬化氧化层。
以下是本发明的假体的具体实施方案,可以单独使用也可与其它实施方案结合使用。
在假体的其它实施方案中,第一假体部分是特征还在于具有一个包括至少一个骨节的承截面的股节部件,第二假体部分是特征还在于具有胫骨基体的胫节部件,所述胫节部件作成与所述承截面相配合。胫节部件可以包含有机聚合物或聚合物基复合物。金属假体基体可以包含锆或锆合金,且扩散硬化氧化层可以是深蓝色或黑色的氧化锆涂层。扩散硬化氧化层的厚度可以高达约20微米。在另一实施方案中,扩散硬化氧化层的厚度可以高达约10微米。
在假体的另一个实施方案中,第一假体部分特征还在于具有一个头部部分和头部部分上的承截面的股节部件,且其中第二假体部分特征还在于具有作成与头部部分上的承截面相配合的内表面的髋臼。所述内表面可以包含有机聚合物或聚合物基复合物。金属假体基体可以包含锆或锆合金,且扩散硬化氧化层可以是深蓝色或黑色的氧化锆涂层。扩散硬化氧化层的厚度可以高达约20微米。在另一实施方案中,扩散硬化氧化层的厚度可以高达约10微米。在一个特定实施方案中,所述假体是脊椎骨假体。优选,所述脊椎骨假体含有锆或锆合金,且扩散硬化氧化层是深蓝色或黑色的氧化锆层。在另一个特定实施方案中,所述脊椎骨假体是椎间盘假体。优选,所述椎间盘假体含有锆或锆合金,且扩散硬化氧化层是深蓝色或黑色的氧化锆层。
在本发明的另一个实施方案中,有一种用于插入患者的身体组织的医用植入物,所述植入物包括一个部件,其中该部件的至少一部分表面是通过如上所述的任何方法进行过织构改性的,并且其中该部件的至少一部分表面包括扩散硬化氧化层。
所述医用植入物发明具有许多特定实施方案,可以单独使用也可与其它实施方案结合使用。所述医用植入物可以是骨板或接骨螺钉。金属假体基体可以包含锆或锆合金,且扩散硬化氧化层可以是深蓝色或黑色的氧化锆涂层。扩散硬化氧化层的厚度可以高达20微米。扩散硬化氧化层的厚度可以高达约10微米。所述医用植入物可以进一步包括一个自接合装置。
上文已经大致描述了本发明的特性和技术优势,目的在于使下述本发明的详细说明更加透彻。本发明的其他的特性和优点将在下文中进行记述,它同时也构成本发明的权利要求的主题。本领域技术人员应当理解,所公开的构思和特定实施方案可以很容易被用作为实施与本发明相同的目的而进行修改或设计其它结构的基础。本领域技术人员还应当理解,那些等价的结构并没有脱离如附加的权利要求书所述的本发明的精神和范围。作为本发明的特征的新颖特性,既包括其结构又包括其操作方法,以及其它目的和优点可以结合附图从以下的说明中更好地理解。然而,应当明确,各个附图都只用于解释和说明的目的,并不是要用作限定本发明的范围。
附图简略说明
图1是表示就位的髋关节假体的示意图。
图2是显示典型的髋关节假体的示意图。
图3是就位的膝关节假体的示意图。
图4是典型的膝关节的部件示意图。
图5是不同表面的抗剪强度的柱状图(包括误差线)。
图6图示了不同表面的销顶出试验的结果。
发明详述
本文中,“一”可以是指一或多。本文中,在权利要求中,当与“含有(包括、包含)”一词连用时,“一”可以是指一或多于一。在本文中,“另一个”可以是指至少第二或更多。
在本文中,术语“医用植入物”包括植入体内的任何装置。它包括假体装置在内且包括骨板和接骨螺钉以及相关装置,不过范围更宽。
本文中,“金属的”可以是纯金属或合金。
本文中,术语“织构改性”用以修饰某个表面时,定义为一个由本领域的已知技术制造的用以提高骨的长入和长上以改进固定稳定性的原表面。它不包括那些只通过加入外来物质来使原表面改性的方法,所述外来物质的组成与原表面可以相同也可以不同,如通过向原表面加入金属珠或金属丝网涂层。与织构改性原表面相反,后面的这些方法仅仅是覆盖了原表面并为骨向内生长和在上生长产生一个新表面。
本文中,“锆合金”定义为任何含锆量大于零的金属合金。即,在本文中锆作为次要组份的合金也看作“锆合金”。同样,任何其它指定金属的“金属合金”(如:铪合金或铌合金;其中的指定金属分别为铪和铌)定义为含指定金属的量大于零的任何合金。
以下记述中包含实施本发明的最优方案的图解和叙述。但是,它们不是限制性实施例。在实施本发明时还可能有其它例子和方法。
本发明涉及提供一种可植入假体装置的增强的附着表面。在假体的全部表面的至少一部分上形成一种由规则图案或不规则表面构成的织构改性表面,其中的假体被或已经被就地氧化过程所表面氧化,结果生成一个厚度通常为20微米或更薄的扩散硬化氧化层。本发明包括其中织构表面和就地扩散硬化氧化表面至少部分占据同一表面区域的假体装置,以及织构表面和就地扩散硬化氧化表面占据不同的和独特的表面的假体装置。唯一的条件是假体装置上某处既具有织构表面又具有就地扩散硬化氧化表面。
发明人已经发现就地形成的扩散硬化氧化层的组合可以协同地改进表面织构改性技术的性能。
表面织构改性
典型的髋关节假体如图1和2所示。髋关节柄2装入股骨,而假体的股骨头6装入髋臼10的内衬8并与其接合,如图1所示髋臼10又固定到骨盆上。通过周围组织向内生长进入多孔涂层,可以引入多孔金属珠或金属丝网涂层12以增进植入物的固定。同样,上述多孔金属珠或金属丝网涂层也可用于髋臼部件。重要地是,区域12可以由织构改性的区域构成,以达到和多孔金属珠或金属丝网涂层相同的目的。
典型的膝关节假体如图3和4所示。该膝关节包括一个股节部件20和一个胫节部件30。股节部件包括提供股节部件的接合表面的骨节22和固定股节部件于股骨上的销钉24。胫节部件30包括一个带有将其固定到胫骨上的销钉34的胫节基体32。胫骨平台36安置在胫节基体32上且带有类似于骨节22的形状的凹槽38。胫节基体、销钉和平台,以及图3所示的假膝的其它部分,是织构改性和扩散硬化氧化的理想选择对象。
上面清楚描述的髋关节假体和膝关节假体仅仅是说明性的,并不是本发明所适用的假体的穷举。本领域技术人员应当理解本发明可以延伸到其它髋和膝关节假体,以及包括但不限于脊椎骨、肩、肘和指假体等其它假体。脊椎骨的应用的例子包括脊椎骨假体如椎体替代物和椎间盘假体及其它。本发明还可应用通常包括但不限于骨板和接骨螺钉等医学植入物。
最普通的表面织构改性方法包括使用掩体和化学蚀刻剂。在这种技术中,掩体是用来保护表面的不同部分,使施加的化学蚀刻剂只侵蚀没有掩体保护的区域。当发明采用化学侵蚀时,其表面是通过利用随机施加的掩体和随后侵蚀金属基体的无掩体保护的区域的刻蚀过程而制备的。根据任一具体应用所需的无规律的量和性质,此刻蚀过程可以重复若干次,也可以只进行一次。蚀刻剂强度以及温度和时间工艺操作条件的控制使得操作人员可以控制由此过程制备的最终表面。重复的次数,以及某一给定的附着表面所使用的具体掩体和蚀刻剂由植入物所用的基底金属决定。虽然在本发明中锆或锆合金植入物被设想成最佳的实施方式,但是应当特别明确任何能够被下面详细记述的扩散硬化处理就地氧化技术氧化的金属基体都可以用作植入物的材料。基底金属的改变可能会要求掩体和蚀刻剂也必须改变。其它适合的基体金属的使用也在本发明的范围之内。
在化学侵蚀实施例中,以随机的方式向要侵蚀的表面施加了掩体。掩体在表面上的随机溅射可以通过用刷子涂刷该表面手工施加掩体或利用装有掩体的任何类型的纤维涂敷装置来实现。另一种施加方法为利用气刷在气流中传送。
选择掩体以提供一种在处理植入物时会紧紧贴在植入物表面,并且在向涂覆部分施加蚀刻剂溶液时能保持稳定的物质。掩体还必须在一个或多个蚀刻剂步骤完成之后没有可除去的残留物。适合的掩体的例子包括,但不限于,丙烯酸掩体、环氧掩体、或聚酯掩体。理想地,一旦刻蚀过程开始后掩体可以产生清晰的边缘而其本身在刻蚀过程中不损坏。
在准备施加掩体时,植入物的表面必须清洁、没有油脂。优选使用金属氧化物粒子、玻璃珠或其它适合的材料进行轻度喷磨处理的机械清洁法。或者,喷铁砂处理也可以。可以单独使用一种溶剂如甲醇,或与喷砂步骤一同使用。掩体可以是任何不受蚀刻剂影响的材料,且可以至少部分地由溶解在载体溶剂中的材料如氯丁橡胶弹性体和α-烯烃共聚物组成。具体的掩体应该与所采用的蚀刻剂类型相适应。掩体的粘度可以通过蒸发载体来提高。采用手工涂抹或喷射技术施加掩体时较厚的掩体通常能产生更好的结果。特别要注意的是,掩体是以随机溅射的方式施加的,使得植入物表面只有一部分被涂敷。优选其中每个掩体点都具有与其它相比不同的尺寸和厚度的随机“圆点花纹”图案。在某些情况下,施加的掩体可以用上述清洁用的喷铁砂技术用80-120目的磨料以80-90psi部分地研磨,以帮助形成不规则的掩体涂层。
根据其应用,掩体的特性可以不同。掩体可以以厚块或薄斑点施加。为获得适当的随机加工表面,理想的是获得各种尺寸和厚度的掩体。每种具体的掩体表面特性都产生一种多少不同的侵蚀结果。在高温下干燥掩体的任选步骤可能会很有用。其条件可以根据掩体的性质而不同,不过通常在200°F下4-5分钟已经足够。
尽管有许多蚀刻剂可以采用,但在一个具体实施方案中使用了现成的标准的30%硝酸/6%氢氟酸的组合。蚀刻剂在110°F施加约4分钟以获得期望的0.008-0.010英寸的刻蚀深度。上述时间长度或蚀刻剂溶液的强度可以上下调整以获得更深或更轻的侵蚀。侵蚀是在水浴或喷雾中停止的。
掩体材料可以以各种方法去除,包括机械方式去除或化学方式去除。有时可以通过对掩体机械刷光或喷砂以剥去掩体。或者,可以用硝酸来溶解掩体材料。
上述表面处理产生许多表面特性。一级水平对应于厚厚施加的掩体水平。厚掩体涂层能完全地保护植入物表面,防止任何金属材料在这一点上被除去。次级水平对应于较薄掩体层。次级水平的中间高度是指在侵蚀周期中掩体起一段时间的作用,但最后在侵蚀周期完成之前就已经失效,使得一些合金被侵蚀掉的区域。结果形成的表面也由逐渐倾斜的表面特性组成,它跟侵蚀周期中部分地保护其下的基体的逐渐缩减的掩体覆盖层相对应。高度倾斜特征标志着能够在侵蚀前取得非常清晰的边界的较厚掩体涂层。中度倾斜特征标志位于上面所述的两种之间的掩体条件。侵蚀的末端由完全没有被侵蚀的区域和那些能显示完全掩体涂层对无掩体涂层的效果的区域指示。还可以进行一次或多次补充的屏蔽和侵蚀循环,结果形成叠加在原来形成的表面上的具有类似特性的图案。由于多次施加屏蔽和侵蚀循环,表面的复杂性升高。各式各样不同程度的凹凸使得骨可以向内生长且保证了骨沿植入物表面牢牢地固定的结构。表面特性被塑造成不规则的形状以促进骨长入。
当使用电化学侵蚀时,对于给定的表面来说掩体和工艺参数的选择由植入物所用的基底金属决定。虽然在本发明中锆或锆合金植入物被设想成最佳的实施方式,但是应当特别理解任何基底金属都可用作植入物材料。基体金属的改变可能需要使用不同的掩体电解液,和电化学侵蚀工艺的不同工艺操作条件。其它适合的基体金属的使用也在本发明的范围之内。任何适合的掩体和电化学侵蚀工艺的操作条件也都在本发明的范围之内。
在掩体材料施加之后,工件的附着表面的裸露部分易受电化学侵蚀。附着表面的裸露部分即没有掩体沉积物覆盖的部分。可以用槽子将工件和阴极浸没在电解液下。工件是该电化学体系的阳极,与直流电源的正极接线柱相连。电解液充满阴极和工件的附着表面之间工作间隙。阴极应当与工件的尺寸相近,这样工件上要被侵蚀的区域的附近到处都是阴极表面。将电解液液体以受控制的速度泵过阴极内的通道,从一个小孔中出来后进入阴极和阳极工件之间的工作间隙。所用电化学设备对于本领域技术人员来说是已知的。在Wagner等人的美国专利US5,922,029中完整描述了一种典型的设备,该专利在此完全引入作为参考,如同在此完全公开。
电化学侵蚀过程所用的电解液优选是符合一加仑水中溶解有NaCl和NaNO3各一磅的比例的溶液。电化学法侵蚀金属领域的技术人员可以判断和采用对于某一具体工件的金属类型所要使用的适合的电解液。控制电解液通过工作间隙的流速很重要,这是因为电解液必须充分地除去电化学法产生的热量和反应产物。最佳流速范围与采用的电流值有关。流速对电流的比值越高,去除热量和反应产物的效果越好。例如,对于电化学侵蚀钴铬合金,电解液应以约0.15-0.5加仑每分每100安培的速度流过工作间隙104,温度在约100-130°F之间。电化学侵蚀金属领域的技术人员将可以确定在某个具体应用中这些参数的合适数值。
阴极可以用任何适用于电化学侵蚀的材料制备,如铜、镍或钨-铜的一种合金。阴极应该设置成使其与工件的附着表面之间的工作间隙基本相等的形式。这一般是通过使阴极基本上正对附着表面来实现的。优选工作间隙在约0.020-0.250英寸之间,更优选在约0.060-0.120英寸之间。电化学侵蚀金属领域的技术人员将可以确定在某个具体应用中的适合的工作间隙。在电化学侵蚀工件时,阴极和附着表面之间的直流电势差保持在约8V-24V之间,附着表面暴露部分的比电流强度保持为至少约50A/in2。优选阴极和附着表面之间的直流电势差在约12-18V之间,每平方英寸附着表面暴露部分上的比电流强度为约75-120安培。当使用其它材料时,电化学侵蚀金属领域的技术人员可以轻易确定这些参数的值。当工件材料为钴铬合金时,所述条件产生的金属去除速度为约0.003英寸/分钟。
优选侵蚀一直进行到达到约0.002-0.007英寸的期望刻蚀深度。电化学侵蚀工艺的时间及其他参数,特别是比电流强度,可以上下调整以获得更深或更轻的侵蚀。电化学侵蚀过程是通过移去阴极和工件之间的电势差而终止的。
优选将屏蔽/电化学侵蚀过程重复三次,尽管用更少或更多次的重复可能获得有用的附着表面。在每个周期中去除的材料的量将由具体的应用决定。优选在每个周期中,去除的材料的量基本相同,以去除的材料的厚度来衡量。当采用多个屏蔽/电化学侵蚀循环时,优选在施加掩体材料之前首先用80-120目的氧化铝磨料对附着表面喷砂,以增进掩体材料的附着力。
化学和/或电化学侵蚀的一般方法的其它变体也是可能的,且在本发明的范围之内。例如,上面的说明包括向要进行织构改性的表面上随机施加掩体,结果形成随机和不规则的表面。或者,掩体可以以一种受控制的方式施加,结果形成印记表面。这种系统的印记表面可以包括有规则的图案,或者可以是不规则的。这可以通过有控制地施加掩体来实现。或者,掩体可以按完全覆盖附着表面,然后系统地并有控制地去除掩体的选定部分以形成具有不同覆盖度的区域的表面的方式来施加。上述有控制地去除可以通过光去除的方法进行,例如用激光烧蚀沉积的掩体。或者,也可以使用化学、电化学或机械去除。或者,通过利用精确控制沉积可以直接获得最终的掩蔽,消除了对侵蚀前部分地除去掩蔽的需要。例如,可以使用化学气相沉积或其它沉积技术。在阅读了此公开之后,本领域的普通技术人员可以很容易想许多其它变体。所有的这些变体都在本发明的范围之内。
本发明的表面改性也可以用来制备自接合表面,在移植时修剪骨的表面或其它组织并将骨或组织材料装入植入物中以增进骨或组织的向内生长或在上生长。目前已知的向内生长和在上生长表面(如,烧结珠、烧结金属丝网、等离子体喷涂等等)都不是为此设计的,也没达到此目的。增强的固定性为扩散硬化氧化表面的高耐磨性提供了理想的补充。
尽管现在提供了本发明的优选实施方案,但是应当明确,本发明并不受它们限制,且在以下权利要求的范围内可以以其它方式实施或应用。
就地形成的扩散硬化氧化层
本发明提供具有上述就地氧化扩散硬化表面、金属基体和织构改性表面的金属矫形植入物或假体。优选,金属基体是锆或锆合金,氧化层是含有深蓝色或黑色的氧化锆的扩散硬化层。其它金属基体,例如,但不限于铪、铌和钽及其合金,也都可以用来形成本发明的氧化层。下面的记述集中在锆和锆合金上,但本发明并不仅限于此。
对于氧化锆,人们已经发现少量的锆就足以产生所要求的扩散硬化氧化层。例如,已经成功地在一种含13%的锆、13%的铌以及余量的钛的合金上形成了所要求的氧化层。氧、铌、和钛包括合金的通常合金元素与通常存在的铪。钇也可以与锆做成合金以在合金的氧化中催进形成一个坚韧的、氧化钇稳定的氧化锆涂层。虽然上述含锆合金可以通过冶金领域技术人员已知的常规方法来定制,但是也有许多适合的合金可商购。这些可商购的合金尤其包括Zircadyne 705、Zircadyne702和Zircalloy。可用于此的合金的其它非限制性例子包括具有高达约4.5wt%的铪和高达约3.0wt%的铌的锆合金、具有高达约4.5wt%的铪的锆合金、具有约2.5-2.8wt%的铌和高达约4.5wt%的铪的锆合金、以及具有约13wt%的铌和13wt%的锆的钛合金。锆的存在不是必须的,因为在类似的氧化条件下,化学性质相近的金属如铪、铌、钛、和钽及其不含锆的合金也可以形成本发明的扩散硬化氧化层。所有的这些金属和金属合金都在本发明的范围之内。上面所列的仅仅是可选择的金属和金属合金的一些例子,并非穷举。
基底金属合金用常规方法浇铸或机加工成所要求的形状和尺寸以得到假体基体。然后将基体置于一定的工艺条件,使得在其表面上自然地就地形成一个紧密粘着的扩散结合的氧化层。上述工艺条件包括,例如空气、蒸汽或水氧化,或在盐浴中氧化。对于锆和锆合金,这些工艺能够理想地在假体基体表面上提供一个薄的、坚硬的、致密的、深蓝色或黑色的、低抗磨损性的,一般为几个微米(10-6米)左右厚的氧化锆膜或涂层。在此涂层下,来自氧化过程的扩散的氧气增加了下面基体金属的硬度和强度。
所述空气、蒸汽、和水氧化过程记述在现在已期满的Watson的美国专利US2,987,352中,其教导在此引入作为参考,如同在此完全公开。空气氧化法能提供一种牢固附着的黑色或深蓝色的具有高度取向的单斜晶形的氧化锆层。如果氧化过程一直持续到过度,涂层会变白并与金属基体分离。氧化步骤可以在空气、蒸汽或热水任一中实施。为方便起见,金属假体基体可以放入具有含氧气氛(如空气)的炉子中,一般在700-1100°F加热长达约6小时。然而,其它温度和时间的组合也是允许的。当采用较高的温度时,氧化时间应当缩短以免形成不希望的氧化物形式。对于锆或锆合金来说,所述不希望的氧化物是白色的氧化物。
对于锆和锆合金,尽管可以使用较厚的高达约20微米的厚度,但是优选应形成厚度在约1到约10微米范围的深蓝色氧化锆层。例如,在1000°F炉内空气氧化3小时会在Zircadyne 705上形成约4-5微米厚的氧化物涂层。较长的氧化时间和较高的氧化温度会增加氧化层的厚度,但可能会损害涂层的完整性。例如,1300°F、1小时会形成约14微米厚的氧化物涂层,而1000°F、21小时会形成约9微米厚的氧化物涂层。当然,由于在所述表面上只要求薄的氧化物,因此只产生非常小的假体厚度的尺寸变化,一般小于10微米。通常较薄的涂层(1-4微米)具有较好的附着强度。
一种可以用来向金属合金假体施加氧化锆涂层的盐浴方法为Haygaith的美国专利US4,671,824中的方法,其教导在此引入作为参考,如同在此完全公开。对于锆或锆合金,盐浴法能提供一种类似的、抗磨性稍强的深蓝色或黑色的氧化锆涂层。该方法要求熔融盐浴中必须存在一种能将锆氧化的氧化化合物。所述熔融盐包括氯化物、硝酸盐、氰化物等等。氧化化合物即碳酸钠的量很少,最高约5wt%。碳酸钠的加入降低了盐的熔点。在空气氧化中,氧化速率与熔融盐浴的温度成正比,在′824专利中优选550-800℃(1022-1470°F)的温度范围。然而,在浴槽中较低的氧含量使得制得的涂层比采用相同时间和温度的炉内空气氧化制得的要薄。在1290°F盐浴处理四小时制备的氧化物涂层厚度为约7微米。
无论采用炉中空气氧化还是盐浴氧化,氧化锆涂层的硬度都非常相似。例如,煅造Zircadyne 705(锆,2-3wt.%铌)假体基体的表面氧化后,表面硬度比原始金属表面的200努氏硬度显著提高。通过盐浴或空气氧化法氧化得到的深蓝色的氧化锆表面的表面硬度约为1700-2000努氏硬度。
这些扩散结合的、低摩擦、高耐磨性的氧化物层至此已经长在处于磨损条件下的矫形植入物的表面上。上述表面尤其包括膝关节、肘和髋关节的接合面。髋假体和膝假体已经在图1和2(髋)及图3和4(膝)中示出。如前面所述,对于髋关节,股骨头和柄一般由金属合金制造,而髋臼可以由陶瓷、金属或有机聚合物衬里的金属或陶瓷制造。在本公开中,我们还讲述了在假体的其它部分使用这些表面。特别是当与织构改性技术结合时,获得的表面表现出增强的固定性能。骨和组织向假体内的生长增强了,相对于常规的假体表面,本发明的表面对骨、组织及其他材料的剪切强度也增强了。
织构改性的扩散硬化氧化物层涂覆的假体的用途并不局限于承载假体,特别是既会遇到高度的磨损且固定又成问题的关节。由于氧化物层涂层牢牢地结合在纯金属或合金假体基体上,它能够在体液与纯金属或合金金属之间提供一层屏障,从而防止合金被电离过程侵蚀和相应释放出金属离子。
织构改性的扩散硬化氧化层表面的性能
剪切强度
我们进行了实验比较不同表面对骨粘结剂的剪切强度:1)织构改性并扩散硬化的氧化表面,2)织构改性但未氧化的表面,和3)既未氧化又未织构改性的表面。这些测试的结果表明氧化的织构表面对骨粘结剂的平均剪切强度相对于未氧化的类似织构表面有很大提高。
在下面的数据中,“1号织构表面”是通过将表面用掩体完全覆盖,然后用可控制的激光烧蚀部分地去除一些掩体,产生掩蔽的表面的过程而形成的。此表面接下来用硝酸/氢氟酸混合物化学侵蚀。然后除去残余的掩体并清洁此表面。“2号织构表面”是通过采用随机溅射技术施加掩体并用硝酸/氢氟酸混合物作蚀刻剂而制备的。在所有情况下,基体都是含2.5%铌的锆合金。
氧化的1号织构表面的平均剪切强度接近500p.s.i.,大于对应的没有氧化的1号织构表面,氧化的2号织构表面的平均剪切强度大于160psi,大于没有氧化的2号织构表面。同样,在一个没有氧化的1号织构表面样品中,发现一些金属微刺在测试中被剪切掉并嵌留在粘结剂中。这种情况在任何氧化的样品中都没发现。看来扩散硬化氧化表面另外还具有增强的对骨粘结剂的剪切强度和抗织构形貌的剪切的优点。数据如下且在图5中有图表表示。
织构 | 试样号 | 材料 | 氧化条件 | 剪切强度[MPA] [PSI] | |
1号织构表面 | 451-4-1 | Zr-2.5Nb | 氧化 | 11.55 | 1675 |
451-4-2 | 12.31 | 1785 | |||
451-4-3 | 10.74 | 1557 | |||
451-4-4 | 12.30 | 1784 | |||
451-4-5 | 13.37 | 1939 | |||
451-4-6 | 10.05 | 1458 | |||
平均 | 11.72 | 1700 | |||
S.D. | 1.20 | 174 | |||
2号织构表面 | 451-5-1 | Zr-2.5Nb | 氧化 | 9.94 | 1442 |
451-5-2 | 9.62 | 1395 | |||
451-5-3 | 10.35 | 1501 | |||
451-5-4 | 10.54 | 1529 | |||
451-5-5 | 8.25 | 1197 | |||
451-5-6 | 12.55 | 1820 | |||
平均 | 10.21 | 1481 | |||
S.D. | 1.40 | 204 | |||
1号织构表面 | 451-6-1 | Zr-2.5Nb | 未氧化 | 8.81 | 1278 |
451-6-2 | 8.92 | 1294 | |||
451-6-3 | 8.25 | 1196 | |||
451-6-4 | 9.19 | 1333 | |||
451-6-5 | 7.78 | 1129 | |||
451-6-6 | 6.79 | 985 | |||
平均 | 8.29 | 1203 | |||
S.D. | .89 | 130 | |||
2号织构表面 | 451-7-1 | Zr-2.5Nb | 未氧化 | 7.64 | 1108 |
451-7-2 | 8.92 | 1294 | |||
451-7-3 | 12.14 | 1761 | |||
451-7-4 | 8.61 | 1249 | |||
451-7-5 | 6.93 | 1005* | |||
451-7-6 | 8.04 | 1166 | |||
平均 | 9.07 | 1316 | |||
S.D. | 1.82 | 264 | |||
喷砂;无其它织构改性 | 1LSZ/2LSZ(前) | Zr-2.5Nb | 未氧化 | 7.38 | 1071 |
3LSZ/4LSZ(前) | 7.81 | 1133 | |||
5LSZ/6LSZ(前) | 8.16 | 1183 | |||
1LS2/2LSZ(后) | 7.79 | 1130 | |||
3LSZ/4LSZ(后) | 7.35 | 1066 | |||
5LSZ/6LSZ(后) | 6.96 | 1009 | |||
平均 | 7.58 | 1099 | |||
S.D. | 0.43 | 62 | |||
喷珠;无其它织构改性 | 269-193/269-202 | Co-Cr | N/A | 3.74 | 542 |
269-199/269-204 | 3.01 | 436 | |||
269-191/269-203 | 3.92 | 568 | |||
269-196/269-205 | 3.40 | 493 | |||
269-197/269-201 | 3.72 | 540 | |||
平均 | 3.56 | 516 | |||
S.D. | 0.36 | 52 | |||
*不合格粘结层的数据没有包括在最终分析中。 |
氧化过程能硬化织构表面,而且人们相信这使得它在植入物受到冲击时可以充当粗锉,磨削骨的切削面并自接合植入物。新磨擦的骨的存在被认为能促进骨生长到织构表面上。未氧化的结构更有韧性但不像这么坚硬,在以这种方式磨削骨的切削面时不会如此有效。从数据中还可看出其它优点。这些结果表明氧化的织构表面对骨粘结剂的平均剪切强度相对于没有氧化的同样的织构表面有很大提高。
绵羊体内研究
在此研究中,绵羊动物模型被用来测定对这些宏观织构且氧化的锆表面的体内生物响应以及它们所提供的最终剪切强度。选择商业上称为ChemTex 5-5-5(CYCAM,Inc.Houston,PA)的织构方法和新开发的商业上称为Tecotex I-103(Tecomet,Woburn,MA)的化学织构方法来制备锆合金(Zr-2.5Nb)上的宏观织构表面(Rmax>0.4mm)。这些织构表面随后被氧化,在全部表面上形成主要由单斜氧化锆构成的约5μm厚的均匀坚硬的陶瓷层。
将ChemTex织构并氧化的锆(CT-OZ)表面和Tecotex织构并氧化的锆(TT-OZ)表面与髋柄和膝股节部件的一种常见固定表面即烧结Co-Cr珠(SB-CC)以及已经在临床上用在全髋部替换部件上的ChemTex织构Ti-6Al-4V(CT-Ti)表面相比较。还研究了未氧化的ChemTex织构锆表面(CT-Zr)。上列五种表面类型,每种制备十二个圆柱形销试样(6.5mm×15mm)。将每个试样植入在绵羊股骨末端的侧面所钻的6.4mm的洞中,每只植入一个销。在术后的两个时期给每种试样的四只绵羊注入骨标记溶液。在术后的第14天和第35天分别以静脉注射的方式注入钙黄绿素(15mg/kg)和土霉素(15mg/kg)溶液。在术后的第六周,动物被施以安乐死,采集股骨。
将每种类型的八个取自没有注入骨标记的动物的试样准备作销顶出试验。首先,紧挨销末端的多骨组织被切除,留下只与打算测试的销表面接触的骨并制备垂直于销轴的平的骨表面。然后用Instron8511伺服液压机械试验架(Instron Corporation,Canton,MA)通过一个直径为4.5mm的钢柱沿销的轴向在销的中部施加一个载荷。用一个限位板来支撑销侧端周围的骨。以0.1mm/s的驱替速率增加载荷,记录取出销所需要的最大的力。
用一次方差分析(ANOVA)对顶出载荷进行统计分析。各小组之间的显著差异用95%的置信区间(p<0.05)来决定。剩余的每种类型的四个来自注入了骨标记的动物的试样被分离出,残留在销周围的骨最小为5mm。然后将骨/试样的样品在4℃、70%的乙醇中固定一周,用一系列等级的醇脱水,并使用Tissue-Tek VIP处理机用氯仿清洗。将样品嵌入异丁烯酸甲酯(MMA),用金刚石锯横向切断。从距离相应的销端约4mm处取“皮层的”和“骨髓的”载面,并磨到50μm的最小厚度。将切片用品绿着色,以辨认组织切片中的骨。
销顶出试验得到了如图6所示的平均的顶出载荷。TT-OZ试样产生的平均顶出力(2.83kN)最大,但这与SB-CC试样的(p=0.53)和CT-OZ试样的(p=0.25)相比并无显著区别。不过,所有三种试样都承受了比CT-Zr表面(p<0.04)和CT-Ti表面(p<0.008)高得多的顶出载荷。CT-Zr和CT-Ti表面(p=0.392)之间没有发现显著区别。组织分析表明,对所有五种表面骨生长都是同位的。对于每种表面,骨分别向下生长到固定表面的最深凹穴,在骨和植入物之间提供机械的交错连接。骨标记显示,对于被研究的所有表面,骨沉积已经被术后第14天所标记,在术后第35天仍在继续。
宏观织构并氧化的锆表面(CT-OZ和TT-OZ)提供的生物固定强度与烧结Co-Cr珠覆盖的表面(SB-CC)相当。这些结果,与组织检查发现的与表面同位的活跃骨生长一起,表明两种形式的宏观织构和氧化的锆表面都提供了相当于烧结Co-Cr珠的临床固定作用。
所有上述三种表面与化学织构Zr-2.5Nb(CT-Zr)和Ti-6Al-4V(CT-Ti)表面相比都表现了显著更强的生物固定强度。值得注意的是剪切强度的改善完全是由于锆合金的氧化。CT-OZ和CT-Zr销试样都使用相同的Zr-2.5Nb合金制造,并以同一方式进行化学织构,但是在织构化过程后氧化了的第一组比留在非氧化条件中的第二组能产生高得多的生物固定强度。
氧化的试样性能改善的原因还不完全清楚,但可能是几个不同因素作用的结果。在宏观织构氧化的锆膝股节研究中,观察到硬化的陶瓷结构“修剪”制备的骨表面,迫使骨微粒进入织构的凹穴中。这可以通过“自接合”的方式促使骨生长到植入物表面上。较软的织构金属表面可能在产生这种效果上稍有不足,而坚硬的陶瓷表面可以增强织构微刺使其更耐骨磨损。此外陶瓷表面还抗蚀且不会释放离子,这些都可能对与表面紧挨的生物组织产生一些影响。无论如何,结果表明织构锆表面的氧化显著提高了可达到的生物固定强度。
尽管已经参照其最佳实施例对本发明进行了说明,本领域的普通技术人员在阅读了此公开之后,可能会想到可以作出一些变化和改进,这些变化和改进并不能超出上述的或下面所要求的本发明范围和精神。
参考文献
说明书中所提到的所有专利和出版物都代表了本发明所属领域技术人员的水平。所有的专利和出版物都在此引入作为参考,如同每篇出版物都逐一地单独指明引入作为参考。
美国专利文献:
2,987,352 6/1961 Watson
4,671,824 6/1987 Haygarth
4,673,409 6/1987 Van Kampen
4,644,942 2/1987 Sump
4,272,855 6/1981 Frey
4,865,603 9/1989 Noiles
5,922,029 7/1999 Wagner等
5,507,815 4/1996 Wagner等
5,258,098 11/1993 Wagner等
6,193,762 2/2001 Wagner等
5,037,438 8/1991 Davidson
5,152,794 10/1992 Davidson
5,169,597 12/1992 Davidson等
5,180,394 1/1993 Davidson
5,370,694 12/1994 Davidson
5,372,660 12/1994 Davidson等
5,496,359 3/1996 Davidson
5,549,667 8/1996 Davidson
其它参考文献:
ASTM的锆和铪手册,J.H.Schemel;专门技术文献639,美国测试和材料学会,费城,宾夕法尼亚州,1977。
本领域技术人员不难看出,本发明非常适合于实施其目的并达到所提到的以及其内在的目标和优点。本文中所述的系统、方法、过程和技术代表着目前优选的实施方案,而且其目的只是示范性的,并不是要作为范围的限制。本领域技术人员会想到它的一些变化或其它应用,这些都包含在权利要求书所定义的本发明的精神之内。
Claims (40)
1.一种在金属基体上制备改性表面的方法,步骤包括:
将所述金属基体的表面的至少一部分进行织构改性;和
将所述金属基体的表面的至少一部分氧化,以在所述金属基体上形成扩散硬化表面。
2.根据权利要求1的方法,其中所述改性步骤特征在于化学或电化学侵蚀。
3.根据权利要求2的方法,其中所述的侵蚀特征在于用酸侵蚀。
4.根据权利要求2的方法,其中所述的侵蚀特征在于另一向金属基体表面施加掩体的步骤。
5.根据权利要求4的方法,其中掩体是随机地施加的。
6.根据权利要求4的方法,其中所述的施加掩体的步骤特征在于向所述金属基体的所述表面上喷涂或溅射掩体的步骤。
7.根据权利要求6的方法,其中所述的喷涂或溅射步骤特征在于随机地施加掩体。
8.根据权利要求4的方法,其中的向金属基体表面施加掩体的步骤特征在于用所述掩体完全覆盖所述表面,然后部分地除去所述掩体的一部分。
9.根据权利要求8的方法,其中所述的部分地除去的步骤特征在于用激光烧蚀所述掩体的一部分的步骤。
10.根据权利要求8的方法,其中所述的部分地除去的步骤特征在于以机械方式除去所述掩体的一部分的步骤。
11.根据权利要求1的方法,其中所述改性步骤特征在于机械侵蚀。
12.根据权利要求1的方法,其中所述改性步骤特征在于在所述表面上的材料沉积。
13.根据权利要求12的方法,其中所述沉积步骤特征在于化学气相沉积。
14.根据权利要求1的方法,其中所述氧化步骤的特征在于空气、蒸汽或水氧化过程。
15.根据权利要求1的方法,其中所述氧化步骤的特征在于使用氧气作氧化剂。
16.根据权利要求1的方法,其中所述氧化步骤包括使用盐浴。
17.根据权利要求1的方法,其中的金属表面是锆或锆合金。
18.根据权利要求17的方法,其中所述的锆合金选自:
具有高至约4.5重量%的铪和高至约3.0重量%的铌的锆合金;
具有高至约4.5重量%的铪的锆合金;
具有2.5-2.8重量%的铌的锆合金;和
具有约13重量%的铌和约13重量%的锆的钛合金。
19.根据权利要求1的方法,其中金属表面含有一种选自铪、铌、钽和钛的金属。
20.一种用于植入的假体,包括第一假体部分和第二假体部分;
所述第一假体部分包括一个承截面,所述承截面作成与所述第二假体部分上的第二承截面相接合或相配合的大小和形状;并且
其中所述第一假体部分或第二假体部分或两者的至少部分表面是通过权利要求1-19中任意方法进行过织构改性的;并且
其中所述第一假体部分或第二假体部分或两者的至少部分表面包括扩散硬化氧化层。
21.根据权利要求20的假体,其中所述的第一假体部分是特征还在于具有一个带至少一个骨节的承截面的股节部件,所述第二假体部分是特征还在于胫骨基体的胫节部件,所述胫节部件作成与所述承截面相配合。
22.根据权利要求21的假体,其中所述的胫节部件包含有机聚合物或聚合物基复合物。
23.根据权利要求21的假体,其中所述的金属假体基体含有锆或锆合金,且其中所述的扩散硬化氧化层是深蓝色或黑色的氧化锆涂层。
24.根据权利要求23的假体,其中所述的扩散硬化氧化层的厚度高至约20微米。
25.根据权利要求23的假体,其中所述的扩散硬化氧化层的厚度高至约10微米。
26.根据权利要求20的假体,其中所述的第一假体部分特征还在于具有头部和头部上的承截面的股节部件,且其中所述的第二假体部分特征还在于具有作成与头部上的承截面相配合的内表面的髋臼。
27.根据权利要求26的假体,其中所述的内表面包含有机聚合物或聚合物基复合物。
28.根据权利要求27的假体,其中所述的金属假体基体含有锆或锆合金,且其中所述的扩散硬化氧化层是深蓝色或黑色的氧化锆涂层。
29.根据权利要求28的假体,其中所述的扩散硬化氧化层的厚度高至约20微米。
30.根据权利要求28的假体,其中所述的扩散硬化氧化层的厚度高至约10微米。
31.根据权利要求20的假体,其中所述的假体是脊椎骨假体。
32.根据权利要求31的假体,其中所述的脊椎骨假体含有锆或锆合金,且其中所述的扩散硬化氧化层是深蓝色或黑色的氧化锆层。
33.根据权利要求31的假体,其中所述的脊椎骨假体是椎间盘假体。
34.根据权利要求33的假体,其中所述的椎间盘假体含有锆或锆合金,且其中所述的扩散硬化氧化层是深蓝色或黑色的氧化锆层。
35.一种用于插入患者身体组织的医用植入物,包括一个其中至少一部分表面是通过权利要求1-19的任意方法进行过织构改性并且其中至少一部分表面含有扩散硬化氧化层的部件。
36.根据权利要求35的医用植入物,选自骨板和接骨螺钉。
37.根据权利要求35的医用植入物,其中所述的金属假体基体含有锆或锆合金,且其中所述的扩散硬化氧化层是深蓝色或黑色的氧化锆涂层。
38.根据权利要求37的医用植入物,其中所述的扩散硬化氧化层的厚度高至约20微米。
39.根据权利要求37的医用植入物,其中所述的扩散硬化氧化层的厚度高至约10微米。
40.根据权利要求35的医用植入物,还包括一个自接合装置。
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- 2002-12-06 WO PCT/US2002/039054 patent/WO2003049781A1/en active Application Filing
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- 2002-12-06 AU AU2002360511A patent/AU2002360511B2/en not_active Ceased
- 2002-12-06 CN CNB028242173A patent/CN1285387C/zh not_active Expired - Fee Related
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- 2002-12-06 US US10/313,205 patent/US7258810B2/en not_active Expired - Lifetime
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US11690723B2 (en) | 2016-08-03 | 2023-07-04 | Titan Spine, Inc. | Implant surfaces that enhance osteoinduction |
US11712339B2 (en) | 2016-08-03 | 2023-08-01 | Titan Spine, Inc. | Titanium implant surfaces free from alpha case and with enhanced osteoinduction |
CN108085631B (zh) * | 2017-11-14 | 2019-10-08 | 上海交通大学 | 一种医用钛合金螺钉的表面处理方法 |
CN108085631A (zh) * | 2017-11-14 | 2018-05-29 | 上海交通大学 | 一种医用钛合金螺钉的表面处理方法 |
CN111270196A (zh) * | 2019-03-07 | 2020-06-12 | 苏州微创关节医疗科技有限公司 | 制备锆铌合金表面氧化陶瓷层的方法及应用 |
CN112296342A (zh) * | 2020-10-30 | 2021-02-02 | 嘉思特华剑医疗器材(天津)有限公司 | 含氧化层锆铌合金分区骨小梁单间室股骨髁及制备方法 |
CN112296342B (zh) * | 2020-10-30 | 2023-03-10 | 嘉思特华剑医疗器材(天津)有限公司 | 含氧化层锆铌合金分区骨小梁单间室股骨髁及制备方法 |
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US20080047931A1 (en) | 2008-02-28 |
EP1453554B1 (en) | 2011-04-13 |
CA2468512A1 (en) | 2003-06-19 |
WO2003049781A1 (en) | 2003-06-19 |
HUP0500442A2 (hu) | 2005-08-29 |
AU2002360511A1 (en) | 2003-06-23 |
US20030125808A1 (en) | 2003-07-03 |
CN1285387C (zh) | 2006-11-22 |
DE60239761D1 (de) | 2011-05-26 |
AU2002360511B2 (en) | 2008-08-28 |
US7258810B2 (en) | 2007-08-21 |
JP2005538745A (ja) | 2005-12-22 |
KR20050044596A (ko) | 2005-05-12 |
EP1453554A1 (en) | 2004-09-08 |
JP2011036692A (ja) | 2011-02-24 |
ATE505216T1 (de) | 2011-04-15 |
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