CN107982582A - 整形外科paek-对-聚合物支承体 - Google Patents

整形外科paek-对-聚合物支承体 Download PDF

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CN107982582A
CN107982582A CN201711250788.1A CN201711250788A CN107982582A CN 107982582 A CN107982582 A CN 107982582A CN 201711250788 A CN201711250788 A CN 201711250788A CN 107982582 A CN107982582 A CN 107982582A
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joint
peek
technical aid
orthopedic technical
uhmwpe
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CN107982582B (zh
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王爱国
张宗涛
丹尼尔·E·劳瑞诺维茨
姚希舜
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Howmedica Osteonics Corp
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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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    • 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
    • A61F2/02—Prostheses implantable into the body
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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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    • A61F2/38—Joints for elbows or knees
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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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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    • 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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    • 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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30014—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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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    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30016—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in hardness, e.g. Vickers, Shore, Brinell
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30065—Properties of materials and coating materials thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
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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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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
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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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Abstract

一种整形外科假体关节包括关节配对，其包括：由聚芳醚酮(PAEK)制成的第一支承体表面；和具有由软于PAEK的聚合物制成的第二支承体例如UHMWPE的第二关节部件，所述第一和第二支承体表面相互滑动地啮合。

Description

整形外科PAEK-对-聚合物支承体
本申请为申请号201010192020.5、申请日2010年6月3日、发明名称为“整形外科PAEK-对-聚合物支承体”的发明专利申请的分案申请。
对相关申请的交叉引用
本申请要求2009年6月4日提交的美国临时专利申请61/217,776的申请日权益，该申请的公开内容在此通过引用并入本文。
背景技术
聚芳醚酮(polyaryl ether ketones,PAEK)，例如，商业化程度最高的PEEK，是公知的聚合物，例如在Marcel Dekker公司出版的《热塑性塑料手册》(Handbook ofThermoplastics)第37章中所述。这些聚合物是高度芳香族化的通常为半结晶的热塑性塑料，并由于其芳香族聚合物骨架而具有高至240℃的转变温度。这些聚合物可通过公知的缩聚方法被合成。PAEK具有优良的耐酸性和耐水性，并能够用伽玛辐射、乙烯氧化物气体和蒸汽消毒。
增强聚醚醚酮(polyetheretherketone,PEEK)已用于整形外科植入物，例如，髋关节假体和髋臼窝。美国专利5,181,930和5,443,513涉及由包括碳纤维增强物的PEEK制成的髋关节假体。PEEK还已用于髋臼窝而作为背衬或支承材料。例如参见美国专利6,638,311和6,758,864。由PEEK制成的柔性髋臼窝还已在美国公开物2007/073410和2007/0191962中提及和论述。在这些方案中相对的支承体，例如股骨头，用陶瓷或金属的支承体表面形成。
美国专利公开物2009/0164023涉及全聚合物支承体配对，其中，每个部分由包括碳纤维增强物的复合材料制成。
20世纪90年代，考虑以PEEK和碳纤维增强PEEK复合物作为潜在的用于全关节更换应用的支承体表面(Wang,A.,Lin,R.,Stark,C.,和Dumbleton JH.,Wear 225-229(1999)724-727)。其目的是，在全髋关节或全膝关节更换中，用PEEK或碳纤维增强PEEK复合物传统金属支承体或陶瓷-对-超高分子量聚乙烯(ceramic-on-UHMWPE)支承体配对，来替代超高分子量聚乙烯(UHMWPE)支承体。已经发现，以陶瓷为配合端面的没有碳纤维增强物的纯PEEK比传统的陶瓷-对-UHMWPE支承体配对具有更高磨损率，而陶瓷-对-碳纤维增强PEEK复合物比传统的陶瓷-对-UHMWPE支承体配对具有更低的磨损率。已经发现，诸如CoCr或不锈钢之类的金属支承体配合端面不适于针对碳纤维增强PEEK复合物的支承体，这是因为由于较硬的碳纤维导致显著的金属表面刮擦。碳纤维增强PEEK-对-PEEK(PEEK-on-PEEK)仅被考虑用于较小的无重量支承体或轻质支承关节(Qi-Bin Bao等人,Nubac DiscArthroplasty:Preclinical studies and preliminary safety and efficacyevaluations,SAS Journal,Winter 2007,Volume 01,issue 01,p.36-45)。已经发现，在磨损测试研究中，随着施加载荷增大，PEEK-对-PEEK出现从低到高的磨损转变(HeatherAustin等人,Exploring the wear of a peek all-polymer articulation for spinalapplication,Society for Biomaterials 2009annual meeting,April 22-25,2009,SanAntonio,TX)。
PTFE-对-PTFE(PTFE-on-PTFE)在1962年之前由Dr.John Charnley首先用做全髋关节的更换(Steven M.Kurtz,The UHMWPE Handbook,p.53-70)。由于磨损性能不佳，因而PTFE-对-PTFE已被放弃。美国专利公开物2007/0270970和971涉及聚合物脊柱支承体部件。
聚缩醛-对-聚乙烯(polyacetal-on-polyethylene)在20世纪80年代作为全聚合物支承体配对被引入全膝关节成形术中，临床结果发表于(1)H.McKellop等人,Super wearproperties of an all-polymer hip prosthesis,31st Annual ORS,Las Vegas,Nevada,Jun.,21-24,1985,322页；(2)D.J.Moore等人。全膝更换假体可完全由聚合物制成(TheJournal of Arthroplasty,Vol.13,No.4,1998)。由于聚缩醛材料(迭尔林Delrin)的伽玛消毒耐受性不佳而且Delrin股部件不适合固定到骨上，因而聚缩醛对聚乙烯不再继续使用。
发明内容
本发明涉及PAEK-对-聚合物(PAEK-on-polymer)(例如超高分子量聚乙烯(UHMWPE))支承体配对，特别是PEEK(聚醚醚酮)对超高分子量聚乙烯(UHMWPE)。PAEK(聚芳醚酮)包括：PEK(polyetherketone,聚醚酮)，PEKK(polyetherketoneketone聚醚酮酮)，和PEKEKK(polyarylether-ketone-ether-ketone-ketone,聚芳醚-酮-醚-酮-酮)，以及PEEK。如果使用PEEK支承体，则可以是：独立的纯PEEK部件，涂覆、模制或移植到另一固体或多孔的聚合物或聚合物复合衬底上的PEEK层，或涂覆、模制或移植到另一固体或多孔的金属或陶瓷衬底上的PEEK层。聚合物支承体可为软于PAEK的任何类型的聚合物。所述聚合物包括但不限于聚乙烯、聚氨酯(polyurethane)、聚酰胺(polyamide)、这些聚合物的复合物，等等。所述聚合物可为：单聚物、共聚物、表面移植聚合物或涂层聚合物。更特别地，本发明涉及无碳纤维增强PEEK-对-UHMWPE(PEEK-on-UHMWPE)，其作为用于整形外科应用的支承体配对。所述支承体用于人造关节，以替换生物关节，例如，髋，膝，肩，肘，手指，和脊柱。
本发明使用纯的(未增强的特别是无碳纤维增强的)PEEK或具有类似性能的PAEK聚合物，以替代在金属-对-聚合物(metal-on-polymer)或陶瓷-对-聚合物(ceramic-on-polymer)配对中作为支承体表面之一的通常的金属或陶瓷。出乎意料的是，发现PEEK-对-聚合物支承体配对(例如，PEEK对聚乙烯)比通常的整形外科支承体配对(例如，金属-对-聚乙烯)具有更低的磨损率。PEEK-对-聚合物的低磨损率的机制可归因于两种机制：(1)总接触压力小。由于PEEK比CoCr具有低得多的杨氏模量(Young’s modulus)，因而PEEK在相同压力下具有高弹性变形，这与在聚合物关节上传统的金属或陶瓷相比，可促进弹性流体动力学上的润滑作用。(2)局部锐度效应：当两个表面接触并相互摩擦时发生磨损。磨损率在很大程度上取决于在标准躯体接触力和湿润滑下表面凸凹结构的锐度和硬度。与CoCr合金(维氏硬度(Vickers)450)相比，PEEK具有极低硬度(约邵氏硬度(Shore)D 85)，由此，PEEK的凸凹结构粗钝且可压缩，而CoCr锐利且坚硬。粗钝凸凹结构比锐利结构更少地磨损配合表面。
本发明提供一种低成本支承体以替代多年来使用的传统的金属或陶瓷支承体。注射成型、模压成型或挤出成型的PEEK材料由于其制造划算而成为低成本支承体。但，本领域技术人员关注的是，与金属或陶瓷相比，PEEK可能存在不佳的耐刮擦性以及在两个聚合物表面之间可能出现的静态阻力。尝试将陶瓷或金属层涂覆在PEEK股骨头上和PEEK膝股骨部件上，涂覆有PEEK的金属和陶瓷头已在之前制成并在此由发明人测试。不过，在整体上将硬的金属和陶瓷涂层结合到软的PEEK衬底上仍不算好。因此，硬涂层的方式被放弃。作为替代方案，尝试将润滑膜(如Toro Moro等人在Nature Materials,published online 24 Oct.,2004,pp.829-836中所述MPC)移植到UHMWPE上以减小摩擦和磨损。MPC根据现有文献中用于X3TM UHMWPE的处理参数进行移植，X3TM UHMWPE是Stryker公司的顺次交联聚乙烯商标产品，如在美国专利7,517,919中所述，在此一并引入作为参考。在此使用的UHMWPE被交联三次，如在专利'919中所述。在此使用的N2VAC是在小于1％氧的氮中以单一3MRad辐射剂量被交联的UHMWPE。在髋关节磨损模拟器中进行磨损测试，用纯PEEK股骨头相对MPC移植聚乙烯窝进行关节连接。
磨损测试的原本目的在于，确定具有MPC移植的PEEK-对-UHMWPE(PEEK-on-UHMWPE)是否有效，而PEEK-对-非移植UHMWPE和CoCr-对-非移植UHMWPE用作对照。假定为了使PEEK-对-UHMWPE支承体配对与传统的CoCr-对-UHMWPE配对在磨损性能上相当，在UHMWPE上的MPC移植是有必要的。不过，去除了MPC移植物的PEEK-对-UHMWPE比CoCr-对-UHMWPE具有更好的磨损性能。这是意想不到的。进一步的试验相对N2VAC采用全PEEK头替代钴铬头进行，并显示出显著减小的磨损率。这些结果表明：无论UHMWPE的交联程度如何，相对UHMWPE，PEEK头作为更坚硬的支承体配对，比CoCr头具有更优的结果。
本发明的一个方案是提供更好的人造支承体配对，其优点在于，与传统的金属-对-聚合物、金属-对-金属、和陶瓷-对-聚合物支承体相比，其低磨损，低硬度，没有金属离子释放，和更低的成本。
在本发明之前，尚未存在用于整形外科应用的PEEK-对-聚乙烯支承体配对。其它类型的公知支承体是：(1)金属或陶瓷-对-碳纤维增强PEEK，(2)PEEK-对-PEEK(PEEK相对其自身用于手指和脊关节)，(3)聚缩醛-对-聚乙烯，和(4)PTFE-对-PTFE(Steven M.Kurtz,UHMWPE handbook,Elsevier Academic press,New,York,2004)。
在此发现的PEEK-对-UHMWPE(与金属-对-UHMWPE相比)的更低磨损率首次提供了在传统的金属-对-UHMWPE支承体配对中替代金属配合端面的可能。在本发明发现PEEK-对-UHMWPE的意想不到的优越磨损性能之前，还没有涉及这种用于整形外科应用的支承体配对的研究报道。包括本发明发明人的研究在内的大多数关于将PEEK作为支承体表面的现有研究集中在使相对于金属或陶瓷配合端面，用PEEK替代作为牺牲性支承体的UHMWPE，而没有人考虑到相对于UHMWPE以PEEK替代金属或陶瓷配合端面。本发明的新颖性在于，PEEK是非牺牲性配合端面，而UHMWPE是牺牲性配合端面。
除了PEEK-对-UHMWPE支承体配对比传统的金属-对-UHMWPE配对具有更低磨损率以外，PEEK具有的弹性模量在subcondra骨(subcondra bone)和皮质骨的弹性模量之间，这使得更多的生理载荷能够传送到植入物和骨的界面处并可能减小或甚至消除在传统的金属或陶瓷植入物中所见的应力遮挡。
由于PEEK-对-UHMWPE支承体配对是全聚合物的，因而其不涉及金属作为支承体表面，由此完全没有金属离子释放，从而不需考虑在一些具有金属对聚合物或金属对金属植入物的患者体内可能出现的金属过敏。
PEEK在关节流体中比聚缩醛具有高得多的抗氧化性和抗水解性，对于PEEK-对-聚乙烯支承体配对而言不存在氧化或水解问题。
PEEK-对-PEEK支承体配对已被考虑用于诸如手指关节和脊柱之类的低负重小关节，与此相比，本发明的PEEK-对-UHMWPE支承体配对既可用于低负重也可用于高负重关节，既可采用如球-内-窝关节(髋关节、脊关节和肩关节)的符合支承体设计(conformingbearing designs)，也可以采用非符合(non-conforming)支承体设计(膝关节、肘关节，等等)。
本发明还涉及使用PEEK作为支承体配对中的较软部分，而使用PEEK作为相对于较软的UHMWPE表面的较硬的支承体关节连接部分。这可能消除许多临床问题，例如与支承体表面磨损、对金属的高敏感性、金属离子释放的毒性和涉及更硬金属或陶瓷植入物的骨应力遮挡相关的问题。应注意，虽然美国专利7,517,919中的顺次交联UHMWPE在此作为示例与PEEK结合作为支承体配对使用，但任何UHMWPE无论其是否交联均可使用。
附图说明
图1的图线显示钴铬合金和非增强PEEK 32mm股骨头在已三次交联的X3TM UHMWPE窝上在1.25×106次循环下的磨损。
图2的图线显示出类似于图1中的测试结果，不过股骨头已被刮擦。
图3是图1的UHMWPE窝在磨损测试之前的照片。
图4是相对图1所示CoCr头使用的UHMWPE窝在磨损测试之后的照片。
图5是相对图1所示非增强PEEK头使用的UHMWPE窝的照片。
图6显示出未被刮擦的PEEK头在测试之前和之后的照片。
图7显示出经刮擦的PEEK头在测试之前和之后的照片。
图8是CoCr和PEEK头相对N2Vac交联UHMWPE的比较。
图9是相对X3TM UHMWPE的作为28mm头的陶瓷氧化铝，25％ZnO2Delta头的比较。
图10和11分别是UHMWPE支承体在与PEEK和CoCr头的磨损测试之前和之后的照片。
图12是CoCr、Delta和PEEK头在测试之后的照片。
图13显示出刮擦(使用金刚石硬度计压头)CoCr、Delta和PEEK头相对X3TM UHMWPE窝的磨损率。
具体实施方式
图1显示出抛光股骨头的髋模拟器磨损结果。该图显示出，在CoCr-对-UHMWPE配对中的X3TM UHMWPE窝具有约2.41mm3/106次循环(Mc)的正体积磨损率，而在具有抛光PEEK头的PEEK-对-X3TM UHMWPE配对中的X3TM UHMWPE窝仅为约0.38mm3/106次循环(Mc)。在PEEK-对-X3TM中，X3TM UHMWPE窝相对抛光PEEK股骨头比相对抛光CoCr股骨头的平均磨损率小约84％。这种磨损率之差具有统计学的显著性(T检测,P＝0.025)。PEEK头的磨损率利用重量分析技术未测得。
图2显示出特意刮擦的股骨头的髋模拟器磨损结果。高度交联聚乙烯窝相对刮擦PEEK头的平均磨损率约为1.82mm3/106次循环(Mc)，而X3TM UHMWPE窝相对刮擦CoCr头的平均磨损率约为16.67mm3/106次循环(Mc)。这表明高度交联聚乙烯窝相对刮擦PEEK头比相对刮擦CoCr头的磨损率低89％。这种磨损率之差在统计学上是显著的(T检测,P＝0.0002)。高度交联聚乙烯窝相对刮擦PEEK头的平均磨损率与相对抛光PEEK头的平均磨损率实际上在统计学上没有显著不同(T检测,P＝0.20)，这表明PEEK-对-高度交联聚乙烯支承物配对，对于PEEK头的刮擦不敏感或不受其影响。与此不同的是，CoCr头的刮擦导致高度交联聚乙烯窝的磨损率几乎增大7倍(T检测,P＝0.0009)。
图3显示出典型的X3TM UHMWPE窝在磨损测试之前(未磨损窝)的白光显微图像。在髋模拟器磨损测试之前，机加工标记清晰可见。表面的峰高度约为5160nm，谷深度约为-4758nm，平均粗糙度约为998nm(Ra)。
图4显示出在具有抛光CoCr头的CoCr-对-UHMWPE配对中的X3TM UHMWPE窝抛光在1.25×106次循环髋模拟器磨损测试之后的磨损表面的白光显微图像。机加工标记消失。表面的峰高950nm，谷深1207nm，平均粗糙度Ra＝80nm。
图5是在具有抛光PEEK头的PEEK-对-UHMWPE配对中的X3TM UHMWPE窝抛光在1.25×106次循环髋模拟器磨损测试之后的磨损表面的白光显微图像。机加工标记仍然可见。表面的峰高1872nm，谷深2715nm，平均粗糙度Ra＝335nm。
图6显示出抛光PEEK头在磨损测试之前和之后的照片。未发现磨损伤痕或粗糙化。
图7显示出特意刮擦的PEEK头在磨损测试之前和之后的照片。在1.25×106次测试循环之后，所有刮擦标记仍然清晰可见。
实验例1
1.5英寸直径的纯PEEK的挤压成型棒购自McMaster，其商标名称为“Quadrant1000(Reading,PA)”，并被机加工为32mm直径的股骨头。32mm的PEEK头被抛光至平均表面粗糙度Ra＝20nm。在髋模拟器中，在2450N最大载荷、1.0Hz、50％稀释牛血清润滑剂中，三个32mm的PEEK头相对三个32mm的顺序交联UHMWPE窝进行测试。三个32mm的CoCr头相对三个32mm的X3TM UHMWPE窝进行相同磨损测试而作为对照标准。
顺序交联聚乙烯窝(X3)(邵氏硬度约为D 70)相对抛光CoCr头(维氏硬度450)和PEEK头(邵氏硬度约为D 85)在髋模拟器上进行1.75×106次循环的磨损结果显示在图1中。在PEEK-对-UHMWPE磨损配对中的X3TM UHMWPE窝具有约0.38mm3/106次循环(Mc)的平均磨损率，而在CoCr-对-UHMWPE磨损配对中的窝具有约2.41mm3/106次循环(Mc)的平均磨损率，这表明对于PEEK-对-UHMWPE配对，具有84％较低的磨损率。这种不同在统计学上是显著的(T检测,P＝0.025)。
实验例2
除了32mm的PEEK头被特意刮擦，然后相对32mm的X3TM UHMWPE窝进行磨损测试以外，其它均与示例1中相同。白光显微图像显示出，刮擦痕迹的峰-到-谷高度约为25微米(μm)，这显著高于以相同方式刮擦的CoCr头的3.5微米。磨损结果表明，相对32mmsX3TM UHMWPE窝以关节连接的经刮擦的32mmPEEK头具有1.82mm3/Mc的平均磨损率(图2)。作为对比，未刮擦的CoCr-对-X3TM UHMWPE对显示出更高的磨损率(2.41mm3/Mc，见图1)。更直接的比较是：使用针对X3TM UHMWPE窝的刮擦CoCr头，根据R.Lee、A.Essner、A.Wang、W.L Jaffe的可在线获知的2009年4月2日的“Scratch and Wear Performance Of Prosthetic Femoral HeadComponents Against Crosslinked UHMWPE Sockets”(Wear,2009)，其平均磨损率约为16.67mm3/Mc。这意味着，刮擦PEEK支承体表面不会显著影响X3TM UHMWPE部分的磨损。这可能是因为：
1.较低的接触应力；
2.在PEEK与聚乙烯之间的自抛光，减小了常见于金属表面刮擦的有害影响；
3.较低硬度和PEEK头上较少尖锐刮擦。
实验例3
除了40mm的PEEK头相对44mm的X3TM UHMWPE窝进行旋转以外，其它均与示例1中相同，其为尺寸不匹配，用于模拟非符合关节(non-conforming joint)，例如膝关节。这种不匹配的PEEK-对-X3TM UHMWPE对不具有可测得的磨损率(重量分析的增重大于减重)。与此相比，完好匹配的32mm的X3TM UHMWPE窝相对32mm的CoCr头的磨损率是可测得的(2.41mm3/Mc，如图1中所示)。
实验例4
除了32mm的PEEK头相对32mm的X3TM UHMWPE窝进行旋转以外，其它均与示例1中相同，其中X3TM UHMWPE窝被移植以MPC(2-甲基丙烯酰羟乙基磷酰胆碱，一种生物相容磷脂，如在Nature Materials,published online:24October 2004,p.829-836中由Toru Moro等人所述)。这种对没有显示出可测得的磨损。
实验例5
PEEK-N2\Vac：28mm的PEEK部件在氧含量小于1％的氮中(N2\Vac)、以3MRad辐射、N2\Vac D尺寸窝的UHMWPE上进行的4.0×106次循环研究发现，测得16.6mm3/Mc的磨损率(SD1.8；n＝7)。作为对比，在对28mm的CoCr头在N2\Vac窝上进行的3.0×106次循环测试研究(HIP231)中，测得30.0mm3/Mc的磨损率(SD 0.022；n＝2)。这相当在于统计学上显著减少了45％的磨损，如图8中所示(p<0.05)。
示例6
PEEK-X3
32mm的PEEK部件在X3TM UHMWPE D尺寸窝上进行5.0×106次循环磨损研究(HIP284)，测得-2.75mm3/Mc的磨损率(SD 1.86；n＝3)，如图9中所示。CoCr、Delta和PEEK/x3、Delta/X3的磨损率取自对于28mm头的现有技术研究。尽管进行了动态载荷和温度补偿均热控制，但相对PEEK头的X3TM UHMWPE窝测试未显示出减重。作为对比，现有公开的Delta陶瓷在X3TM UHMWPE窝(28mm；n＝3)上的磨损率也显示在图表中(0.55mm3/Mc，SD 0.58)。当相对PEEK头进行测试时，X3TM UHMWPE窝上的机加工标记在3.5×106次循环时也仍然可见(图10)；而相针对CoCr头进行测试时，机加工标记在0.75Mc时即不可见(图11)。
如图10中所示的机加工标记在3.5×106次循环时仍可见。如图11中所示，标记在CoCr头进行0.75×106次循环时由于较高磨损率而不再可见。
在这样的相同研究中，利用现有技术中公知的金刚石压头方法(30N，螺旋样式)使PEEK头形成刮擦痕迹。这些头显示出约40μm PV的显著伤痕(与CoCr的7.1μm和Delta的0.30μm相比)，如图12中所示。然后，这些头用来做相对X3TM窝的4.5×106次循环磨损测试。对PEEK/X3配对而言，在4.5×106次循环之后的磨损率为-3.1mm3/Mc(SD 1.827；n＝3)。在相同的循环次数下，这与未刮擦的PEEK/X3TM支承体在统计学上并没有不同(p＝0.353)。作为对比，在现有技术中公开的研究中，经刮擦的28mm的CoCr部件呈现出19.6mm3/Mc的磨损率(SD0.5；n＝2)，而经刮擦的28mm的Delta部件呈现出0.58mm3/Mc的磨损率(SD 0.43；n＝2)，如图13中所示。
CoCr和Delta的数据取自如Lee,R.等人的“Scratch and wear performance ofprosthetic femoral head components against crosslinked UHMWPE sockets,Wear267,pages 1915-1921,2009”中公开的现有技术研究。
此外，三个40mm的PEEK头相对44mm的F尺寸的X3插件进行测试。这种研究用于确定在较高应力的不符合支承体状况下的磨损率。在1.0×106次循环时，这种支承体的磨损率为0.60mm3/Mc(SD 503)。
PEEK头磨损尚未量化测量。采用N2\Vac窝上的PEEK头，显示出磨损上显著减小了45％。在X3TM窝上的PEEK头的磨损率是负值。当PEEK头严重磨蚀时，磨损率不变。当测试不符合(44mm的X3TM窝上的40mm的PEEK头)几何时，磨损率保持接近于零(但为正值)。PEEK头的磨损将在测试完成后进行评估。
在UHMWPE上的纯PEEK的全聚合物支承系统(软对软)已经显示出于意料的结果，例如，其磨损率低于UHMWPE上的CoCr，而无论PEEK股骨头是否被刮擦。
供应PAEK的其它公司是：BASF,UltraPAEK,PEKEKK；Dupont,Ureton PEKK,Declar；OPM,Oxford Performance Materials,Inc.PEKK；Hoechst Celanese(Hostatec)-PEEKK5and ICI(Vitrex),PEK and PEEK。医用级PEEK的供应商是：ICI,Invibo,Solvay和Evonik。
虽然本发明在此已经参照具体实施例进行了描述，不过应理解，这些实施例仅用于例示本发明的原理和应用。因此，应理解，在不背离由所附权利要求书所限定的本发明的精神和范围的情况下，基于示例性实施例可进行多种修改并可设计其它构造。

Claims (19)

1.一种整形外科假体关节，包括：
关节配对，其具有由PAEK制成的第一支承体表面和具有由软于PAEK的聚合物制成的第二支承体的第二关节部件，所述第一和第二支承体表面呈相互滑动地啮合。
2.如权利要求1所述的整形外科假体关节，其中，所述软于PAEK的聚合物选自包括聚乙烯、聚氨酯、聚酰胺、及其聚合物的复合物的组。
3.如权利要求1所述的整形外科假体关节，其中，所述第二支承体的聚合物可为单聚物、共聚物、表面移植或涂层聚合物。
4.如权利要求2所述的整形外科假体关节，其中，所述第二支承体包括交联或非交联的聚乙烯。
5.如权利要求1所述的整形外科假体关节，其中，所述PAEK支承体是没有碳纤维或玻璃纤维增强物的纯PEEK。
6.如权利要求5所述的整形外科假体关节，其中，所述PEEK支承体是独立部件。
7.如权利要求5所述的整形外科假体关节，其中，所述PEEK支承体包括被涂覆、制模或移植到固体或多孔聚合物衬底上的纯PEEK层。
8.如权利要求5所述的整形外科假体关节，其中，所述PAEK支承体包括被涂覆、制模或移植到固体或多孔金属衬底上的纯PAEK层。
9.如权利要求5所述的整形外科假体关节，其中，所述PEEK支承体包括被涂覆、模制或移植到固体或多孔陶瓷衬底上的纯PEEK层。
10.如权利要求5所述的整形外科假体关节，其中，骨接触表面包括用于骨向内生长的多孔PAEK层。
11.如权利要求1所述的整形外科假体关节，其中，所述关节选自包括髋关节、膝关节、脊柱关节、肩关节、肘关节、脚趾关节、手指关节和踝关节的组。
12.如权利要求1所述的整形外科假体关节，其中，所述第二支承体包括交联聚乙烯。
13.一种整形外科假体关节，包括：
第一支承体表面，其由无纤维增强PEEK制成；和
第二支承体表面，其与所述第一支承体表面滑动地接触，所述第二支承体表面由超高分子量聚乙烯(UHMWPE)形成。
14.如权利要求13所述的整形外科假体关节，其中，所述UHMWPE通过辐射、辐射后加热和每次加热后冷却而被交联至少三次。
15.如权利要求13所述的整形外科假体关节，其中，所述PEEK支承体包括被涂覆、制模或移植到固体或多孔聚合物复合物衬底上的纯PEEK层。
16.如权利要求13所述的整形外科假体关节，其中，所述PEEK支承体包括被涂覆、制模或移植到固体或多孔金属衬底上的纯PEEK层。
17.如权利要求13所述的整形外科假体关节，其中，所述PEEK支承体包括被涂覆、制模或移植到固体或多孔陶瓷或陶瓷复合物衬底上的纯PEEK层。
18.如权利要求13所述的整形外科假体关节，其中，骨接触表面具有用于骨向内生长的多孔PEEK层。
19.如权利要求13所述的整形外科假体关节，其中，所述聚乙烯已通过辐射被交联。
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