CN101394811B - 用于关节置换的假体 - Google Patents
用于关节置换的假体 Download PDFInfo
- Publication number
- CN101394811B CN101394811B CN200780007817.XA CN200780007817A CN101394811B CN 101394811 B CN101394811 B CN 101394811B CN 200780007817 A CN200780007817 A CN 200780007817A CN 101394811 B CN101394811 B CN 101394811B
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- CN
- China
- Prior art keywords
- superabrasive particles
- matrix
- complex
- joint
- diamond
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
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- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00299—Ceramics or ceramic-like structures based on metal nitrides
- A61F2310/00305—Ceramics or ceramic-like structures based on metal nitrides containing boron nitride
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- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00574—Coating or prosthesis-covering structure made of carbon, e.g. of pyrocarbon
- A61F2310/0058—Coating made of diamond or of diamond-like carbon DLC
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- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- A61F2310/00856—Coating or prosthesis-covering structure made of compounds based on metal nitrides
- A61F2310/00862—Coating made of boron nitride
Abstract
本发明包括具有改进的耐磨损性、包括复合材料的假体。所述复合材料可以包括分散在另一材料的连续基体中的磨料或超级磨料材料。所述假体可以部分或全部由复合材料形成，或者可以在一个或更多个表面上用复合材料包覆。实施方案包含包括复合材料的假体关节和关节连接表面。附加的实施方案包括制造包括复合材料的假体的方法。
Description
相关申请的交叉引用：
本申请要求2006年3月6日递交的、题目为“用于关节置换的假体”的美国临时专利申请No.60/779,542的优先权，并且通过引用将所述美国申请的披露内容的全部包括在本文中。
关于联邦赞助研究或开发的声明：不适用。
联合研究协议方名称：不适用。
序列表：不适用。
背景
所公开的实施方案总地涉及修复术(prosthetics)和关节置换的领域，并且更具体地，涉及用于在该领域中使用的材料以及制造这些材料的方法。关节置换手术，包括髋、膝和肩置换，正变成一种日益普遍的过程。关节的运动一般包括两个表面相对于彼此的摩擦，例如在髋关节中股骨顶部或头在骨盆窝(髋臼)中的旋转，从而所述表面受到磨耗。所述磨耗随时间而可能导致这些支撑型表面之间配合的松弛并且将残片(debris)引入人体。因此，存在对没有其他低磨耗设计的缺点(即高成本、高复杂性和高破碎风险)的持久的、低磨耗关节置换假体的需要。
发明内容
本发明总地涉及修复术，并且更具体地涉及用于关节置换的假体以及制造这些假体的方法。本发明的一个实施方案是一种假体，所述假体包括至少两个关节连接表面(例如头和窝)，其中所述关节连接表面中的至少一个包括磨料复合物。根据实施方案，所述复合物包括分散在基体材料中的超级磨料或其他磨料材料(例如超级磨料颗粒)。在实施方案中，所述复合物包括分散的磨料相和连续的基体相。在另一实施方案中，所述复合物包括分散的磨料微粒和连续的基体相。根据本发明，所述磨料颗粒不具有显著的颗粒间结合(bonding)。
所述磨料材料可以包括超级磨料颗粒。所述基体可以包括各种材料，例如金属、陶瓷或树脂。在实施方案中，所述磨料材料附着于所述基体。所述磨料材料构成至少约20％的所述复合物。根据一些实施方案，所述的基体的抗磨损性低于所述磨料相。在本发明的假体中使用的复合物由生理学上惰性的材料构成。在实施方案中，所述复合物包含少于5％的颗粒间结合。在实施方案中，所述复合物包含少于10％的颗粒间结合。在实施方案中，基体中的所述颗粒是金刚石颗粒，并且所述复合物不包含sp3金刚石间结合。
在一个实施方案中，在本发明的假体中使用的复合物具有小于约20mm3/分钟的线性磨耗率(ASTM G65或类似标准)。在另一实施方案中，在本发明的假体中使用的复合物的线性磨耗率低于约15mm3/分钟。在实施方案中，在本发明的假体中使用的复合物的线性磨耗率低于约7mm3/分钟。在实施方案中，在本发明的假体中使用的复合物具有小于30μm/天的磨耗率(Taber)。在实施方案中，在本发明的假体中使用的复合物具有小于10μm/天的磨耗率。在实施方案中，在本发明的假体中使用的复合物具有小于0.5的摩擦系数。在实施方案中，在本发明的假体中使用的复合物具有小于0.25的摩擦系数。在实施方案中，在本发明的假体中使用的复合物具有小于0.2的摩擦系数。
本发明的另一实施方案是一种假体关节，所述假体关节包括：具有关节连接支撑表面的第一构件，以及具有第二关节连接表面的第二构件，所述第二表面和所述第一关节连接表面相符合(conform to)。所述一个构件或两个构件包括这样的复合物，所述复合物包括分散在连续基体中的分散的磨料颗粒。所述分散的颗粒可以包括超级磨料颗粒。一实施方案是一种假体关节，所述假体关节包括髋臼杯和股骨头，其中所述杯和头中的每一个包括关节连接支撑表面；并且所述表面中的至少一个包括在连续基体中的分散的颗粒的复合物。
本发明的另一实施方案是一种可植入假体，包括具有支撑表面的连接关节，其中所述表面中的至少一个包括包含在连续基体中的分布的硬相的复合物。所述复合物可以包含磨料、超级磨料或前述分散在基体材料中的颗粒的组合。所述基体可以包括例如金属、陶瓷或树脂。所述磨料、超级磨料或组合的颗粒可以附着到所述基体材料。所述磨料、超级磨料或组合的颗粒可以总共构成(comprise)所述复合物的至少约20％。
本发明的一实施方案是一种用在假体关节中的关节连接表面，所述表面包括复合物。所述表面可以包括具有分散的磨料相和连续的基体相的复合物。根据另一实施方案，所述表面包括结构基底和复合物覆层，其中所述复合物覆层包括分散的磨料颗粒和连续的基体相，并且其中所述连续的基体相附着到磨料颗粒并且附着到所述基底。所述表面磨料可以包括超级磨料颗粒。
如本文进一步描述的，本发明还包括制造包括复合物的假体的方法。
附图简要说明
图1描绘Ni-P/金刚石复合物覆层的横截面。
具体实施方式
在描述本方法、系统和材料之前，要理解本公开不限于所描述的特定方法、系统和材料，因为这些可以改变。还要理解，在本描述中使用的术语仅用于描述特定版本或实施方案的目的，而不打算限制范围。例如，如在这里和所附权利要求书中使用的，除非上下文以其他方式明确指出，否则单数形式“一(an，an)”和“所述”包括复数指代。此外，使用在这里，词汇“包括”意指“包括但不限于”。除非以其他方式限定，否则在这里使用的所有技术和科技术语具有如本领域普通技术人员所普遍理解的相同含义。
这里描述的实施方案探讨“超级磨料(superabrasive)”材料在关节置换假体中有益的耐磨耗和低摩擦性质，而没有与之前提出的途径相关联的复杂性、缺点或高成本中的一种或更多种。超级磨料是具有至少约2000努氏硬度(Knoop)或更高硬度的材料，例如金刚石和立方氮化硼。超级磨料由于其极高的硬度和抗磨损性而与“常规”硬颗粒或磨料颗粒(诸如氧化铝、氧化锆、碳化硅、碳化钨和生物学上感兴趣的陶瓷)相区别。
在本发明的一个实施方案中，提供了包括分散或分布在另一材料的基体中的磨料颗粒或超级磨料颗粒的复合材料。在本发明中使用的磨料和超级磨料颗粒的直径一般小于约500微米，并且优选地小于约100微米。本发明的复合材料可以用于包覆(coat)关节置换假体的关节连接表面中的一些或全部，或者可以用于形成整个假体本身。
所述连续基体可以是诸如金属、金属合金、聚合物、常规陶瓷、非共价陶瓷、非碳化物陶瓷、玻璃、复合物或其组合的任何材料。优选地，基体材料的抗磨损性低于超级磨料的抗磨损性。优选地，所选择的材料是生理学上惰性的。复合物的超级磨料颗粒可以以任何含量或体积分数存在，但是一般为至少约20％体积，以提供期望的耐磨损性。超级磨料颗粒的示例性含量范围包括约20到约50体积百分比，约25到约50体积百分比，约25到约40体积百分比，约50到约70体积百分比，以及约15到约70体积百分比。
根据实施方案，在本发明的假体中使用的复合物具有小于约20mm3/分钟的线性磨耗率(ASTM G65或类似标准)。在本发明的假体中使用的复合物的线性磨耗率可以低于约15mm3/分钟，或者可以低于约7mm3/分钟。在实施方案中，在本发明的假体中使用的复合物具有小于30μm/天的Taber磨耗率。在实施方案中，在本发明的假体中使用的复合物具有小于10μm/天的磨耗率。在实施方案中，在本发明的假体中使用的复合物具有小于0.5的摩擦系数。在实施方案中，在本发明的假体中使用的复合物具有小于0.25的摩擦系数。在实施方案中，在本发明的假体中使用的复合物具有小于0.2的摩擦系数。
在实施方案中，磨料或超级磨料颗粒附着到基体。虽然不希望受理论所限，本实施方案中的颗粒可以通过机械结合、主要化学结合、次要相互作用(例如但不限于分散力、范德华相互作用)、氢键结合等等的任何组合附着到基体。颗粒可以被包覆以提高它们对基体材料的附着性，或者防止基体材料与颗粒发生化学反应。在单种复合物中可以使用多于一种的颗粒类型。基体还可以包含其他分散的或连续的相以提供其他功能，所述相包括填料、增强须(whisker)或纤维、提高生物相容性的生物活性材料、生物学上感兴趣的非超级磨料或陶瓷、滑润剂或其他材料。
包括离散的超级磨料颗粒和连续的基体的复合材料可以被实施为整个部件(component)、组件(assembly)中的子部件，或者实施为背衬(backing)材料上的层或覆层。所述复合物和/或部件可以被后处理(post-process)以进一步改善性能。后处理可以包括诸如热处理或退火的批量处理，或者诸如精研、抛光的表面处理，或者以诸如润滑剂或填充材料的其他材料包覆。
与现有技术不同，这里描述的复合材料不包含显著量的磨料间(例如金刚石间)结合；相反，所述颗粒基本上分散(即离散)在连续基体内。这样，复合物的磨料(包括超级磨料)颗粒包括在连续基体内的非连续相，以及少于25％的颗粒形成颗粒间结合。在实施方案中，复合物包含少于10％的颗粒间结合。在实施方案中，复合物包含少于5％的颗粒间结合。在实施方案中，基体内的颗粒为金刚石颗粒，并且复合物不包含sp3金刚石间结合。
对这样的复合材料的使用在降低现有技术解决方案的复杂性、成本和不期望的性质(例如脆性)的同时提供了改进的耐磨损性和相关联的优点。除载有陶瓷承的聚合物(ceramic-loaded polymer)外，每个现有技术的解决方案均包括单一材料或烧结复合物，其中存在着磨料材料的粒间结合，使得磨料材料大部分为连续相。例如，包括烧结PCD的现有技术在金刚石粒子之间具有实质上的结合，形成连续的金刚石基体。类似地，陶瓷的关节连接表面包括陶瓷粒子的烧结，以形成固形(solid)部件。在这两种情况中，烧结过程增加成本并且导致不期望的性质。其他解决方案，例如DLC包覆(coating)、CVD金刚石包覆、陶瓷包覆、金属和聚合部件，在关节连接表面包括单一材料或合金。载有陶瓷承的聚合物具有分布的陶瓷颗粒，但是该领域中的工作已经被限于具有低抗磨损性的陶瓷，并且在大多数情况下限于在生物学上感兴趣的陶瓷。
本发明的一个实施方案涉及包覆金属关节置换部件的一个或更多个表面，例如髋置换假体的球(ball)和/或窝(即股骨头和髋臼杯)，其中复合物覆层由金属基体和诸如金刚石的超级磨料颗粒构成。可替换地，所述假体可以用于肩、膝或其他关节。这样的覆层可以通过任何数量的方法来施加，所述方法包括无电镀(electroless plating)或电镀(electrolytic plating)、热喷涂方法、气相沉积方法、阳极处理等等。使用对施加技术和表面准备的适当选择，覆层的金属基体将牢固地附着到金属部件体，由此克服一些DLC和CVD金刚石覆层的限制。在一些实施方案中，复合物包含约30到约40体积百分比的金刚石和/或其他超级磨料。在其他实施方案中，复合物包含直至70体积百分比的金刚石和/或其他超级磨料。如这里所描述的，其他超级磨料含量是可能的。
在一些情况下，金属基体可以被选择为具有与基材(base)部件相同或类似的组成。例如，钛-金刚石复合物覆层可以被施加到具有当前用于关节假体中的类型的钛基材，或者金刚石、钴和/或铬的复合物可以施加到钴/铬部件。金属基体-磨料复合物覆层的一个实施例是使用在专利文献(美国专利3,936,577；4,997,686；5,145,517；5,500,330；5,863,616；6,306,466，每一篇这些美国专利的公开内容通过引用被包括在本文中)和相关文献(例如R.Barras等人的“Electroless Nickel Coatings-Diamond Containing(含金刚石的无电镀镍覆层)”，无电镀镍会议，1979年11月，辛辛那提，俄亥俄州)中描述的无电镀方法制备的Ni-金刚石复合物。图1中的显微图示出具有镍-磷作为金属基体而金刚石作为分布的相的复合物覆层。其他金属基体以非限制性的方式可以包括无电镀铜、钴或银。电解处理的实施例可以包括铬、镍、铂或铁。
另一种为关节置换假体的关节连接表面形成金属-超级磨料复合物的途径是在金属部件或金属部件的部分中嵌入超级磨料。嵌入可以在正形成部件时发生，或者作为后成形处理发生。例如，可以在铸造金属基体时向金属基体中加入超级磨料，或者在粉末金属工艺中作为组分加入。对于某些可以耐受温度和化学环境的超级磨料材料或被包覆的超级磨料来说，在铸造期间将超级磨料颗粒加入到熔融金属中是可能的。更实际并且可能更广泛应用的途径是使用粉末化的金属。粉末化的金属可以与超级磨料颗粒共混，并且例如通过注模或压模来模制为关节连接表面。需要提高的温度来烧结金属粒子以及在超级磨料颗粒周围形成连续或半连续的金属基体。可以如热等静压中那样正在施加压力时施加所述温度，或者在所谓的免烧结操作中在形成“料坯(green body)”之后施加所述温度。选项包括将整个部件形成为金属-超级磨料复合物，在部件基材的关节连接表面上施加金属-超级磨料复合物层，或者甚至施加分级的(graded)金属-超级磨料复合物，在所述分级的金属-超级磨料复合物中磨料的含量可以随在部件中的位置而改变。在一些实施方案中，覆层厚度可以在约20到约500微米厚之间。其他厚度是可能的。
另一实施方案包括具有聚合基体和分布的超级磨料颗粒的复合材料。金刚石或立方氮化硼颗粒可以以多种方式加入到聚合物基体中，所述方式包括但不限于在压模之前共混树脂和超级磨料颗粒、将超级磨料复合到熔融树脂中以用于注模、溶液涂布，或者在固化或交联之前共混。树脂可以具有任何形式，包括填充的、未填充的或增强的热塑性塑料，热固性材料，交联的聚合物，环氧树脂等等。所述复合物可以包括其中超级磨料遍布其分布的整个部件、附着到其他材料背衬的层、基底上薄的一体式层或者覆层，或者其中超级磨料含量朝关节连接表面增加的部件。分级的或者分层的结构可以例如通过形成粉末层、通过包含超级磨料和不包含超级磨料的熔融物的共注，或者通过在分布超级磨料微粒之后将聚合物或溶液引入模子中来形成。可能需要机加工、研磨、成型或者其他方式的后处理来将该复合物/部件转换为其最终形式，以用于假体中。
另一实施方案包括具有陶瓷基体和分布的超级磨料颗粒的复合材料。可以使用用于通过在形成料坯和/或烧结前在超级磨料颗粒中共混陶瓷粉末来制造陶瓷体的任何工艺制造该复合物。同样，所述超级磨料复合物可以是整个关节置换部件、该部件的关节连接表面上集中的(concentrated)层，或者具有较高的超级磨料颗粒含量的分级的复合物。尽管该复合物可以具有对现有陶瓷关于脆性和破碎的类似限制，但是超级磨料具有进一步提高耐磨损性的潜力。
另一实施方案是由分布在金属-陶瓷共复合物(例如Excera Materials Inc.以ONNEX名称开发和营销的那些)中的超级磨料颗粒构成的复合物。这些基体材料是陶瓷和金属的双连续(co-continuous)复合物，具有在10微米(μm)量级的畴宽度(domainwidth)。可以在形成料坯之前将超级磨料与金属和陶瓷粉末一起引入。同样，该包含超级磨料的复合物可以是本体部件(bulk component)、关节连接表面上的层，或者其中超级磨料含量朝关节连接表面增加的分级的复合物。
这里描述的途径可以扩展到常规的磨料，以例如提高具有分布的磨料粒子的关节置换假体的金属关节连接表面的抗磨损性。例如，其中分散有碳化硅磨料颗粒的镍基体可以被用在本文所描述的应用中。本发明因此包括具有改进的磨耗性、由包括分散在连续基体中的磨料材料的复合物形成或包覆的假体。示例性复合材料可以具有约20体积百分比或更多的磨料，其中约25到约40体积百分比为优选范围。
本发明可应用于人体修复术，但是还可以被利用在兽医修复术中。本发明还包括制造所公开的修复术器件的方法。
实施例
在一组测试中，通过用具有受控尺寸和组成的砂来磨损测试样本来测量耐磨损性。该测试基于ASTM G64标准的过程C，其中测试样本被压在旋转轮(具有橡胶边缘)上，同时受控砂流在轮旋转方向上被引入到轮和测试样本之间的间隙中。以200转每分钟(rpm)的轮速和130牛顿的负载使用DUOCOM干磨测试器。具有约200到约300μm粒径的AFS50-70石英砂以30克/分钟被馈送到所述间隙达30秒。
测试的样品是以具有变化的粒径、金刚石体积分数和磷含量的Ni-P或Ni-P/金刚石复合物无电镀包覆的304不锈钢试样。用于包覆无金刚石Ni覆层的包覆方法为标准的无电镀Ni；Ni-P/金刚石复合物的包覆在R.Barras等人的“Electroless NickelCoatings-Diamond Containing(含金刚石的无电镀镍覆层)”(无电镀镍会议，1979年11月，辛辛那提，俄亥俄州)和美国专利No.3,936,577；4,997,686；5,145,517；5,300,330；5,863,646和6,306,466中描述。所有Ni-P和Ni-P/复合物试样均在约400摄氏度在氮中被热处理1小时，以提高它们的抗磨损性。对比测试的是裸露的不锈钢试样以及以硬铬、钨铬钴合金(Stellite)和氧化铝-二氧化钛(13重量百分比的二氧化钛)覆层包覆的试样。通过标准的镀敷方法沉积硬铬至200μm的厚度，Stellite-6为钴基的硬质焊敷层，通过焊接沉积至500μm的厚度，并且通过等离子喷涂(其中Ni-Al-B-Si的结合覆层厚度为10μm)使氧化铝-二氧化钛沉积至约100μm的厚度。所有样品均在丙酮超声波浴中清洁10分钟、干燥并且在测试前称重。
在干磨测试之后，样品再次在超声波浴中清洁10分钟、干燥并重新称重。基于质量损失来确定耐磨损性，使用覆层密度转换为体积，并且以立方毫米每分钟(mm3/min)来报告。在所有情况下，磨耗测试均在覆层深度被穿透之前完成。
Ni-P覆层(4％的P)以28.3mm3/min的速率磨耗，而所有Ni-P/金刚石复合物(4％和9％的P)以2.4到6.5mm3/min的速率磨耗。具有30体积百分比的平均粒径为2μm金刚石的覆层为平均最佳表现，具有2.9mm3/min的平均磨耗。具有25体积百分比的平均粒径为0.25μm金刚石的覆层也表现良好，具有4.1mm3/min的平均磨耗率。具有40体积百分比的平均粒径为8μm金刚石的覆层平均为6.2mm3/min的磨耗率。较高的磷水平在一定程度提高复合物覆层的抗磨损性，而覆层厚度(在50和200μm之间)则没有影响。但是，数据明确显示了在具有相同基体材料的金属表面(Ni)和Ni/金刚石复合物之间存在4到10倍的抗磨损性的提高。作为比较，裸露的不锈钢以大于60mm3/min磨耗，而Stellite覆层的磨耗率大于50mm3/min。相对于Ni-P，陶瓷的氧化铝-二氧化钛覆层和硬铬覆层分别显示了大致22mm3/min和7mm3/min的改进的耐磨损性，然而它们中无一表现得与任一Ni-P/金刚石复合物一样好。事实上，最好的Ni-P/复合物粗略地7倍优于(7X better than)陶瓷覆层。
使用了销-盘摩擦计(pin-and-disc tribometer)来测量滑动磨耗和摩擦。来自CSM Instruments SA的该器具具有一样品保持器，在该保持器中具有高度5-10mm、直径55mm的盘(包覆的或未包覆的)可以被安装并螺接到所述器具。另一接触材料是具有6mm直径和10mm高度的销。所述盘可以以0-500rpm的速度旋转，而所述销为固定的。销保持器将销紧紧地保持在底部，靠着所述盘。对于所有测试，销被加载10牛的负载。测试以0.5米/秒的滑动速度进行2000米。通过计算机界面得到了摩擦系数相对于时间和滑动距离的记录(trace)。通过在测试前后测量重量获得了盘和销的磨耗损失。在重量测量进行前样品以超声波的形式在丙酮中清洁。上面描述的覆层被用于该测试中。
当销和盘以相同的材料包覆时，盘上(以10E-5mm3/min来报告)的干磨耗因子对于Ni-P来说为3.4，而对于Ni-P/金刚石复合物来说为1.1到1.7，即2到3倍的提高。对于销的磨耗因子也更好，对于Ni-P为0.44，对于Ni-P/金刚石复合物为0.15到0.3。Ni-P/金刚石复合物还优于裸露的304不锈钢、氧化铝-二氧化钛以及Stellite，裸露的304不锈钢、氧化铝-二氧化钛以及Stellite具有30、151和14的盘磨耗率。硬铬有竞争力地为1.6，但是，基于通过向Ni-P覆层引入金刚石所看到的提高，如果在复合的铬/金刚石复合物覆层中存在金刚石，则人们将希望类似的提高。对于这些替换性材料的销磨耗显示了同样的趋势。
Ni-P/金刚石复合物还具有低得多的摩擦系数。相对于Ni-P0.55的摩擦系数、硬铬0.72的摩擦系数、Stellite0.76的摩擦系数以及裸露的304不锈钢0.63的摩擦系数，具有2和8μm的粒径的Ni-P/金刚石分别具有0.17和0.12的摩擦系数。很清楚，含金刚石的复合物降低了滑动部件间的磨擦。
还进行了在另一标准测试——Taber测试中的磨耗测试，以将Ni-P覆层与Ni-P/金刚石复合物进行比较。以1000克的负载和CS-10轮使用型号5130Taber测试器进行5000周(cycle)。具有8μm粒径的复合物的磨耗率仅为0.2μm/天，具有2μm粒径的复合物的磨耗率为4μm/天，具有0.25μm粒径的复合物的磨耗率为7μm/天。相比之下，Ni-P覆层以30μm/天磨耗。再一次，这些数据证明了分布在基体中的超级磨料粒子所述提供的提高的耐磨损性。
应该意识到，各种上面公开的以及其他特征和功能，或者它们的替换方案，可以以期望的方式组合到很多其他不同的系统或应用中。因此，本领域技术人员可以作出其中的各种当前未预见或未预料的替换方案、修改、变体或改进，这些替换方案、修改、变体或改进打算被所附权利要求书包括。
Claims (9)
1.一种假体，包括：
至少两个关节连接表面；
其中所述关节连接表面中的至少一个包括磨料复合物，所述磨料复合物包括分散在基体材料中的超级磨料颗粒，所述超级磨料颗粒具有至少2000努氏的硬度，
其中所述超级磨料颗粒是金刚石，所述基体材料是Ni-P覆层，
其中，所述金刚石的平均粒径为0.25μm并且具有25体积百分比；或者所述金刚石的平均粒径为8μm并且具有40体积百分比，并且
其中少于25％的所述超级磨料颗粒形成金刚石颗粒间结合。
2.如权利要求1所述的假体，其中所述超级磨料颗粒附着于所述基体材料。
3.一种假体关节，包括关节连接表面，所述关节连接表面包括：
具有分散的磨料相和连续的基体相的复合物，所述磨料相包括分散在基体材料中的超级磨料颗粒，所述超级磨料颗粒具有至少2000努氏的硬度，其中所述超级磨料颗粒是金刚石，所述基体材料是Ni-P覆层，其中，所述金刚石的平均粒径为0.25μm并且具有25体积百分比；或者所述金刚石的平均粒径为8μm并且具有40体积百分比，其中少于25％的所述超级磨料颗粒形成金刚石颗粒间结合，所述基体相的抗磨损性低于所述磨料相。
4.一种假体关节，包括：
结构基底；以及
关节连接表面，所述关节连接表面包括复合物覆层；其中所述复合物覆层包括：分散在基体材料中的超级磨料颗粒，所述超级磨料颗粒具有至少2000努氏的硬度，其中所述超级磨料颗粒是金刚石，所述基体材料是Ni-P覆层，其中，所述金刚石的平均粒径为0.25μm并且具有25体积百分比；或者所述金刚石的平均粒径为8μm并且具有40体积百分比，其中少于25％的所述超级磨料颗粒形成金刚石颗粒间结合；以及
基体相，其中所述基体相包括连续的金属基体、连续的陶瓷基体或者双连续的金属-陶瓷基体，并且其中所述基体相附着到所述超级磨料颗粒并且附着到所述基底。
5.一种假体关节，包括：
具有关节连接支撑表面的第一构件；
具有关节连接表面的第二构件，所述关节连接表面和所述关节连接支撑表面相符合；
其中一个表面包括，或两个表面都包括，具有在基体中的分散的超级磨料颗粒的复合物，所述超级磨料颗粒具有至少2000努氏的硬度，其中所述超级磨料颗粒是金刚石，所述基体是Ni-P覆层，其中，所述金刚石的平均粒径为0.25μm并且具有25体积百分比；或者所述金刚石的平均粒径为8μm并且具有40体积百分比，其中少于25％的所述超级磨料颗粒形成金刚石颗粒间结合。
6.一种假体关节，包括：
髋臼杯；以及
股骨头；其中所述杯和头中的每一个包括关节连接支撑表面；
其中所述表面中的至少一个包括一复合物，所述复合物包括在基体中的分散的超级磨料颗粒，所述超级磨料颗粒具有至少2000努氏的硬度，其中所述超级磨料颗粒是金刚石，所述基体是Ni-P覆层，其中，所述金刚石的平均粒径为0.25μm并且具有25体积百分比；或者所述金刚石的平均粒径为8μm并且具有40体积百分比，其中少于25％的所述超级磨料颗粒形成金刚石颗粒间结合。
7.一种可植入假体，包括：
具有支撑表面的连接关节；
其中所述支撑表面中的至少一个包括一复合物，所述复合物包含在基体中的分布的硬相，所述复合物包括分散在基体材料中的超级磨料颗粒，所述超级磨料颗粒具有至少2000努氏的硬度，其中所述超级磨料颗粒是金刚石，所述基体是Ni-P覆层，其中，所述金刚石的平均粒径为0.25μm并且具有25体积百分比；或者所述金刚石的平均粒径为8μm并且具有40体积百分比，其中少于25％的所述超级磨料颗粒形成金刚石颗粒间结合。
8.如权利要求7所述的假体，其中所述超级磨料颗粒附着于所述基体材料。
9.一种假体，包括：
至少两个关节连接表面；
其中所述关节连接表面中的至少一个包括磨料复合物，所述磨料复合物包括分散在基体材料中的金刚石颗粒，其中所述基体材料是Ni-P覆层，其中，所述金刚石的平均粒径为0.25μm并且具有25体积百分比；或者所述金刚石的平均粒径为8μm并且具有40体积百分比，并且所述复合物不包含sp3金刚石颗粒间结合。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US77954206P | 2006-03-06 | 2006-03-06 | |
| US60/779,542 | 2006-03-06 | ||
| PCT/US2007/063369 WO2007103911A2 (en) | 2006-03-06 | 2007-03-06 | Prosthesis for joint replacement |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101394811A CN101394811A (zh) | 2009-03-25 |
| CN101394811B true CN101394811B (zh) | 2013-09-04 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN200780007817.XA Expired - Fee Related CN101394811B (zh) | 2006-03-06 | 2007-03-06 | 用于关节置换的假体 |
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| Country | Link |
|---|---|
| US (1) | US20070208427A1 (zh) |
| CN (1) | CN101394811B (zh) |
| DE (1) | DE112007000527B4 (zh) |
| GB (1) | GB2449388B (zh) |
| WO (1) | WO2007103911A2 (zh) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8308812B2 (en) | 2006-11-07 | 2012-11-13 | Biomedflex, Llc | Prosthetic joint assembly and joint member therefor |
| US8070823B2 (en) | 2006-11-07 | 2011-12-06 | Biomedflex Llc | Prosthetic ball-and-socket joint |
| EP2081520B1 (en) * | 2006-11-07 | 2017-07-12 | Biomedflex, LLC | Medical implants |
| US20110166671A1 (en) | 2006-11-07 | 2011-07-07 | Kellar Franz W | Prosthetic joint |
| US9005307B2 (en) | 2006-11-07 | 2015-04-14 | Biomedflex, Llc | Prosthetic ball-and-socket joint |
| US8029574B2 (en) | 2006-11-07 | 2011-10-04 | Biomedflex Llc | Prosthetic knee joint |
| CN104546226A (zh) * | 2013-10-11 | 2015-04-29 | 浙江一火科技有限公司 | 一种人工髋关节及其制备方法 |
| US9883946B2 (en) * | 2014-08-13 | 2018-02-06 | Sparkle Medical Llc | Composite prosthetic surfaces |
| US11008655B2 (en) * | 2016-03-03 | 2021-05-18 | Lam Research Corporation | Components such as edge rings including chemical vapor deposition (CVD) diamond coating with high purity SP3 bonds for plasma processing systems |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4547910A (en) * | 1981-05-18 | 1985-10-22 | Rensselaer Polytechnic Institute | Low friction bearing surfaces and structures particularly for artificial prosthetic joints |
| US6290726B1 (en) * | 2000-01-30 | 2001-09-18 | Diamicron, Inc. | Prosthetic hip joint having sintered polycrystalline diamond compact articulation surfaces |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3936577A (en) | 1971-12-15 | 1976-02-03 | E. I. Du Pont De Nemours & Company | Method for concomitant particulate diamond deposition in electroless plating, and the product thereof |
| US5300330A (en) | 1981-04-01 | 1994-04-05 | Surface Technology, Inc. | Stabilized composite electroless plating compositions |
| US5145517A (en) | 1981-04-01 | 1992-09-08 | Surface Technology, Inc. | Composite electroless plating-solutions, processes, and articles thereof |
| US6306466B1 (en) | 1981-04-01 | 2001-10-23 | Surface Technology, Inc. | Stabilizers for composite electroless plating |
| US5863616A (en) | 1981-04-01 | 1999-01-26 | Surface Technology, Inc. | Non-ionic stabilizers in composite electroless plating |
| US4764172A (en) * | 1986-11-28 | 1988-08-16 | Mccoy Allen J | Articulated ankle |
| US4997686A (en) | 1987-12-23 | 1991-03-05 | Surface Technology, Inc. | Composite electroless plating-solutions, processes, and articles thereof |
| ZA9510267B (en) * | 1994-12-06 | 1996-06-12 | De Beers Ind Diamond | Abrasive body |
| US7556763B2 (en) * | 1999-12-08 | 2009-07-07 | Diamicron, Inc. | Method of making components for prosthetic joints |
| EP1880694B1 (en) * | 2000-03-29 | 2012-01-11 | Massachusetts Institute of Technology | Controllable prosthetic joint system |
| IL166447A0 (en) * | 2002-07-24 | 2006-01-15 | Excera Materials Group Inc | Improved ceramic/metal material and method for making same |
| US7270679B2 (en) * | 2003-05-30 | 2007-09-18 | Warsaw Orthopedic, Inc. | Implants based on engineered metal matrix composite materials having enhanced imaging and wear resistance |
-
2007
- 2007-03-06 CN CN200780007817.XA patent/CN101394811B/zh not_active Expired - Fee Related
- 2007-03-06 US US11/682,391 patent/US20070208427A1/en not_active Abandoned
- 2007-03-06 GB GB0814966A patent/GB2449388B/en not_active Expired - Fee Related
- 2007-03-06 DE DE112007000527.0T patent/DE112007000527B4/de not_active Expired - Fee Related
- 2007-03-06 WO PCT/US2007/063369 patent/WO2007103911A2/en active Application Filing
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4547910A (en) * | 1981-05-18 | 1985-10-22 | Rensselaer Polytechnic Institute | Low friction bearing surfaces and structures particularly for artificial prosthetic joints |
| US6290726B1 (en) * | 2000-01-30 | 2001-09-18 | Diamicron, Inc. | Prosthetic hip joint having sintered polycrystalline diamond compact articulation surfaces |
Also Published As
| Publication number | Publication date |
|---|---|
| GB0814966D0 (en) | 2008-09-24 |
| CN101394811A (zh) | 2009-03-25 |
| US20070208427A1 (en) | 2007-09-06 |
| GB2449388A (en) | 2008-11-19 |
| WO2007103911A3 (en) | 2007-12-13 |
| DE112007000527B4 (de) | 2016-09-08 |
| WO2007103911A2 (en) | 2007-09-13 |
| GB2449388B (en) | 2011-08-17 |
| DE112007000527T5 (de) | 2009-01-15 |
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