CN1230207C - 骨代用品材料 - Google Patents
骨代用品材料 Download PDFInfo
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- CN1230207C CN1230207C CN98811730.4A CN98811730A CN1230207C CN 1230207 C CN1230207 C CN 1230207C CN 98811730 A CN98811730 A CN 98811730A CN 1230207 C CN1230207 C CN 1230207C
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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
- 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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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/42—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix
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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
一种可用作骨代用品材料的坚固的多孔性制品。它具有限定整个体积形状的外表面,并具有延伸贯穿整个体积,并开放通向外表面的相互连通的开放性空隙。该制品包含连续的坚固框架结构,此结构具有贯穿整个体积相互连通的空隙,该制品还包含第二种连续的结构材料,此材料占据至少与框架结构相同总体积的一部分。第二种材料包含骨诱导性和/或骨传导性组合物。这种组合物可以几种形式中的一种形式存在。其中第一种是作为框架结构表面的包涂层。第二种形式是复合材料的形式,在框架结构的支柱内紧密地用框架材料混合。第三种形式是作为框架结构空隙内的多孔性物质,具有彼此相互连通的,并与框架结构的空隙相互连通的孔隙。理想的情况是,这种多孔的骨诱导性或骨传导性组合物延伸贯穿整个体积。在优选的实施方案中,其框架结构是由陶瓷材料构成。在另一个实施方案中,其框架结构可用完整地粘接于它的致密的材料成分,作进一步结构加强。
Description
发明领域
概括地说,本发明是关于骨代用品材料,特别是关于能够支持或促进骨生长进入其孔隙内的多孔材料。
发明背景
在骨折或其它骨损伤的情况下,适当的骨愈合和随后良好的骨重建,都高度依赖于保持骨碎片之间的稳定性,以及,在骨脱钙的情况下,主要取决于保持其生理应变力水平。使用外部的紧缚绷带和铸型固定等方式,可以获得外部的结构支撑。内部的结构支撑通常是借助于内部固定装置如骨板,螺钉和髓内连杆等来提供,其中的一些在晚些时候可能需要通过外科手术除去,所有的这些,对于病人都可能是令人忧虑的负担和损伤性的。
因此,需要一种可作为骨代用品的产品,它既能作为骨移植材料,还能提供结构支撑作用。在替换或修复下肢长骨,以及为了用于脊椎融合技术时尤其是如此。创伤,骨质疏松,严重的骨关节炎或类风湿性关节炎,关节置换和骨癌,都可能需要包括使用结构性骨代用品材料在内的治疗。
成功的骨移植需要有为骨长入提供支架的骨传导性基质;提供诱导骨再生和修复的化学作用剂的骨诱导因子;借助于它们能分化为成骨细胞和破骨细胞的能力,为骨再生提供基础构件块的生骨细胞,并且还需要对移植位置提供结构完整性,以使得将被移植物支持的负荷适当。
目前的骨移植材料包括自体移植物(使用来自该病人的骨),同种异体移植物(使用尸体骨),以及多种人造的或合成的骨代用品材料。自体移植物由松质骨和/或皮质骨组成。松质骨移植物实际上不提供任何结构完整性。当此移植物引入,并在其下面建造新骨时使骨强度增加。对于皮质骨,此移植物最初可提供某些结构强度。但是,当受移植骨渗入此移植物时,不能存活的骨将通过重吸收被除去,使此移植物的强度显著地降低。使用自体移植骨还可能在取骨位置对病人造成严重的疼痛,并且,可从病人获取这种骨的数量当然是很有限的。同种异体移植物类似于自体移植物,它们也由松质骨和/或皮质骨组成,但可获得较多的数量和体积。对同种异体移植物的消毒方法可能会损害此种移植物的结构和生物化学特性。使用同种异体移植骨至少要承担转移疾病的某些危险,以及移植物可能不能很好地被结合的危险。
对于可方便使用的结构性骨修复材料,它们必须能够形成为适合修复位置的外形所设计的复杂形状。外形精确相符的移植物将会增进天然骨的整合作用,并可提供较好的负荷支撑能力。为了促进可引导受移植骨渗入移植物的骨重建和再生,常常要求天然骨和骨代用品材料之间有紧密的负荷支撑接触。
在如下文献中给出了对可植入矫形术材料的概述:Damien,Christopher J.,和Parsons,Russell J.,“骨移植和骨移植代用品:对当前技术及其应用的述评”,应用生物材料杂志,Vol.2,pp.187-208(1991)。
已有多种材料被建议用作骨代用品材料,一方面包括适合于在膝关节和髋关节替换物周围填充缺陷的成形多孔金属物体,另一方面还包括成形陶瓷材料。一般来说,可通过烧结处理使陶瓷材料成形,其中是先将陶瓷材料如氧化锆的粉末在模具内压制成所需要的形状,然后加热至烧结温度。这样所形成材料的多孔性通常是非常低。采用磷酸钙(例如:氟磷灰石,羟磷灰石和磷酸三钙)的材料也可以用这种方式烧结,这种磷酸钙具有充当骨生长基质的能力(骨传导性)。
已有人建议先将陶瓷粉末如氧化锆和羟磷灰石,或者氟磷灰石和尖晶石混合均匀,然后在模具内压制此混合物,并烧结或均匀地热压形成稍微多孔的氧化锆陶瓷,这种陶瓷具有至少部分地填充了羟基磷灰石的孔隙。参阅Tamari等的美国专利4,957,509,以及Aksaci,D等,用于骨桥的多孔氟磷灰石/尖晶石骨陶瓷,陶瓷会刊,Vol.48,p 283(1995)。还有人建议使用既具有高多孔结构部分,又具有低多孔结构部分的陶瓷制品,参阅Hakamatsuka等的美国专利5,152,791,Johansson的美国专利5,464,440,和Borom的美国专利4,237,559。还可参见Klawitter等的美国专利4,000,525。后一参考文献是使用Al2O3滑泥,使其发泡形成多孔结构,然后加热烧制。
总的来说,被提议用于骨代用品的金属或陶瓷材料都是低孔隙度的,此制品包括例如具有以磷酸钙基础材料填充或包涂的部分多孔表面的基本上致密的金属和陶瓷。所形成的结构具有致密的金属核心或陶瓷核心,以及核心材料和磷酸钙组合物的表面,或者基本上是磷酸钙的表面。这种类型的骨代用品材料通常重而且致密,并且常常是结构明显地比骨坚硬。参阅美国专利5,306,673(Hermansson等),4,599,085(Riess等),4,626,392(Kondo等),和4,967,509(Tamari等)。
发明概述
本发明提供了一种坚硬的,敞口分隔成小室的制品,它可用作骨代用品材料,并且是高度多孔性的,这样可容许骨向其内生长,它是低密度的,并包含促进骨向其内生长的物质。
在一个实施方案中,本发明涉及一种敞口分隔成小室的制品或网络结构,它具有限定整个容积的外表面,和具有延伸贯通整个体积并开口通向外表面的相互连通的孔道。该制品包含一种连续的支撑性坚固框架结构,优选地是陶瓷结构,此框架结构具有分隔许多贯通整个体积的相互连通空隙的支柱,此制品还包含一种多孔的骨传导性组合材料,此组合材料携带于支撑性框架内,并暴露于相互连通的孔道。这种多孔的骨传导性组合材料占据至少与框架成分相同总体积的一部分。合乎要求地,本发明的制品具有在20%-90%范围内的空虚体积,优选地至少为50%。进而,此支撑性框架成分孔道的平均尺寸,合乎要求地至少为50μm,优选地在200μm-600μm的范围内。
在一个优选的实施方案中,其支撑框架和骨传导性组合物每种都是显示出3,3连通性的连续的三维结构,并占据至少相同总体积的一部分,而优选地是其全部,每种连续的结构都具有与其它孔道相互连通的孔道。骨传导性组合物可能是包含在支撑框架的孔隙内,优选地是作为支柱表面的连续相,并且骨传导性组合物的孔隙与支撑框架结构的空隙连通,但可能与它们一起共同延伸或不延伸。
在还有另一实施方案中,其支柱是由一种混合物或复合材料组成,它们含有支撑性材料以及骨传导性材料,此支撑性材料为制品提供强度,而骨传导性材料至少部分地携带于其空隙的表面,这样使它暴露于相互连通的孔道,以便提供有助于骨生长的骨传导性环境。
在另一个实施方案中,本发明包括上述几种类型中任何一种的敞口分隔成小室的制品,它包含附着于第一种材料整个体积表面的第二种基本上是致密的连续性材料成分,此第二种成分具有不大于其总体积10%的孔隙度。这种基本上是致密的相,可能是陶瓷,聚合物,金属或复合材料,此产品可能具有作为可移植假肢的髋部心柱或胫骨托盘的用途。
附图说明
图1是本发明基于陶瓷制品的示意图,显示其支撑结构连续的开放性特点;
图2是本发明基于陶瓷制品的示意图,显示支撑性框架支持物空隙内的泡沫状骨传导性材料;
图3是本发明一个实施方案的示意图,其中的支柱是含有支持物和骨传导性材料的组合物;
图4是采用本发明一个实施方案的股骨假肢的剖面视图;和
图5是采用本发明一个实施方案的胫骨托盘修复术的剖面视图。
优选实施方案详述
在制备本发明的制品时,优选地是从形成坚硬的开放性框架开始,此框架具有尺寸范围在大约50μm-1000μm范围内的空隙,优选地是大约200μm-600μm,并且具有至少约30%的空虚容积,优选地是至少约50%,而最优选的是至少70%。此框架的材料可包括任何坚硬的,生物相容性材料,例如陶瓷材料,金属和复合材料如氧化锆/羟基磷灰石或氧化锆韧化的矾土。优选地,此框架成分是一种陶瓷材料,氧化锆和矾土。
在一种优选的方法中,是通过使陶瓷粉如氧化锆与一种有机粘合剂和水混合形成分散体,而制成陶瓷材料的滑泥浆。用这种陶瓷滑泥浆浸湿和包涂一种有机的网状泡沫胶的支柱表面,此泡沫胶可以是例如由聚亚胺酯,聚酯或聚醚等构成的各种市售泡沫胶的一种。可将此网状材料浸泡在滑泥浆内,然后取出并沥干除去多余的滑泥浆。如果需要,可通过多种方法中的任何一种,进一步除去多余的滑泥浆,包括使此材料在一对紧密间距的滚筒之间通过,或通过以一股气流冲击此材料。改变此滑泥浆的浓度,粘滞度和表面张力,可对保留在泡沫胶支柱表面的滑泥浆的量提供控制。为此目的湿润剂和粘滞度控制剂也可以使用。可以应用广泛多种网状的敞口材料,包括天然和合成的海绵状材料,以及编织的和非编织的材料,只是在此实施方案中必不可少的是,此敞口的多孔材料能够使陶瓷滑泥浆材料,通过结构中的孔道基本完全地渗入。
一旦用滑泥浆包涂了网状支柱,可通过干燥法除去滑泥浆的溶剂,理想的是温和地加热,然后对此结构升温至烧结温度,在此温度下,陶瓷颗粒至少部分地相互烧结形成类似于网状支柱构型的,坚固的具有少量网架的结构。在达到烧结温度之前,合乎要求地是使经滑泥浆处理过的海绵状材料保持在能使有机材料热解或烧去的温度下,遗留下不完全烧结的陶瓷框架结构,然后使它升温至适当的烧结温度。
对于大多数有机物,热解或氧化温度的范围大约是200℃-600℃,而对于与本发明有关的大多数陶瓷,烧结的温度范围是大约1100℃-1600℃。对于这些结构成分,氧化锆和矾土,或者基于氧化锆和矾土的组合物是优选的陶瓷材料。用于骨传导性部分的陶瓷材料的实例包括,磷酸钙(例如羟基磷灰石,氟磷灰石,磷酸三钙以及它们的混合物),生物活性玻璃,骨传导性水泥,以及含有硫酸钙或碳酸钙的组合物。
可用于形成强硬的连续性框架成分的金属包括钛,不锈钢,钴/铬合金,钽,钛-镍合金如Nitinol(镍钛金属互化物),以及其它一些超弹性金属合金。参阅:Itin等,“多孔性Nitinol的机械性能和形状记忆”,材料品质鉴定[32],pp.179-187(1994);Bobyn等,“多孔性钽植入材料的骨向内生长的动力学和表面力学”,矫形学研究学会,第43届年会会刊,p.758,1997年2月9-13日,加州旧金山;以及Pederson等,“对用于治疗无血管供应坏死的多孔性钽材料的有限成分品质鉴定”,矫形学研究学会,第43届年会会刊,p.598,1997年2月9-13日,加州旧金山,所有这些资料均被引入作为参考。
可借助于多种加工程序使金属形成坚硬,连续的支撑性框架结构,包括燃烧合成,喷镀在一种“泡沫胶”基质上,化学烟雾沉积法(见美国专利5,282,861),脱模技术(见美国专利3,616,841),起泡沫的熔融金属(见美国专利5,281,251,3,816,952和3,790,365),以及如用于陶瓷粉末所述的,用金属粉末淤浆对网状的多聚泡沫胶进行复制。
适合用于本发明的骨传导性材料和骨诱导性材料是生物学可接受的材料,骨传导性材料包括如胶原蛋白和包括羟基磷灰石,磷酸三钙和氟磷灰石在内的各种形式的磷酸钙,骨诱导性物质包括例如:骨形态发生蛋白(例如rhBMP-2),脱矿物质的骨基质,转化生长因子(例如TGF-β),成骨细胞,以及已知诱导骨形成的各种其它的有机物质。骨诱导物质如BMP也可以用于本发明的制品,例如,通过在I型胶原蛋白稀释悬液中的这种物质的水溶液中浸泡此制品。可将骨诱导物质如TGF-β,在含有有效浓度TGF-β的生理盐水中用于本发明的制品。
可以认为,具有相互连通空隙或孔道的连续性支撑框架是主要的负荷承受成分,骨传导性材料通常比此支撑框架弱。如上面所述,此支撑性框架优选地是由陶瓷材料如氧化锆构成。如此形成的框架结构,使其空隙或孔道本身的宽度,平均大于分隔相邻空隙的支柱的厚度。这种负荷承受框基本上是完全连续性的,本身按三维结构相互连接,其孔隙部分基本上也是完全连贯的,本身也以三维空间相互连通。这二个三维相互连接的部分是彼此渗透的。可以把这种结构称为3-3连通性结构,在此第一个数字指的是连接负荷承受框架结构的维数,第二个数字指的是连接孔隙部分的结构维数。在Newnherm等的如下论著中对此连通性概念作了比较详细的说明;“连通性和压电复合材料”,材料研究公报,Vol.13,pp.525-536(1978),特此引入此文献作为参考。对于在此所述的支撑框架,因为它是按3维连接,框架本身有数字3,对于其孔隙部分也可同样看待。相比之下,部分地被烧结的粉末组合物,恒定地含有一些不与所有的其它孔隙连通的分隔的小孔和空隙。在一种致密的基质中含有完全分隔的(即盲端)小孔的材料,具有3-0的连通性。一种材料具有一维通过基质完全相通的小孔,此材料构成3-1的连通性,而一种材料具有除了第三个面外有二个垂直而相互连通的小孔,此材料将具有3-2的连通性。
在支撑框架中孔道的尺寸优选地是至少约50μm,并且优选地是在200μm至大约600μm的数量级。优选地是基本上没有小于50μm的小孔或空隙。应该理解的是,此支撑框架中的孔道是无数不规则形状的孔道。通过它可发生生物向内生长过程的相互连通的孔道或空隙,构成了在其中骨可向内生长并形成血管的三维迷宫,也就是说,这些孔道具有与其它孔道的许多连接处,因此构成了通过此框架的曲折路径。一般认为,为了适当地支持骨向框架的孔道内生长,这些孔道必须能够容纳具有至少约50μm横切面积的组织管道。从概念上可简便地想像,本发明材料中一个50μm的孔道,能够容纳一条具有圆形切面和50μm横径的“蠕虫”通过它。换句话说,50μm的孔道应该使具有50μm直径的小球能够通过它。虽然还没有我们已知的用于测量孔道尺寸完全满意的方法,但是有可能测定本发明制品断面的扫描电子显微镜照片,观察其结构的平面投影,画几条穿过此显微镜照片的直线,测量与此直线相交的孔道,并且可应用均分和标准的偏离技术,使之能够估算出这些孔道的尺寸。
本发明制品的一个重要特点是,制品的空隙至少部分地保持敞开,甚至存在骨传导性和/或骨诱导性材料。“敞开”,在意义上是指这些空隙没有被堵塞,液体可以从一侧到另一侧完全地通过此制品。
当用于构成支撑性框架时,氧化锆和其它的陶瓷是非常硬的,并且远比骨更坚硬。虽然理想的是应用具有更近似于骨弹性模量的材料作为支撑性框架,但是,本发明应用具有完全开放空隙的坚硬材料的骨代用品材料也能良好地起作用。据认为,在愈合过程中,当侵入的骨深深地渗透进入该制品的空隙时,骨与这种多孔制品的最终结合发生在较大的表面积和深度上。坚固的骨/陶瓷界面导致压力能够容易地转移至陶瓷框架,并且从此框架移开,同以小面积的表面对表面接触和很少或没有骨渗透进入此制品的骨/陶瓷结合形成的结构相比较,具有显著较小的应力集中。
当使用的骨传导性材料是一种陶瓷如羟基磷灰石等磷酸钙,并且其支撑框架是一种陶瓷如氧化锆时,可采用几种方法制备本发明的制品。如上面所述,可通过如下步骤制造支撑性氧化锆框架结构:先在网状有机材料如聚亚胺酯,聚酯或聚醚等泡沫胶的支柱表面包涂氧化锆滑泥浆,随后对包涂的泡沫胶升高温度,以便驱除滑泥浆的溶剂,热解或烧去有机泡沫胶材料,最后加热此陶瓷,导致陶瓷颗粒至少部分地烧结。
一旦此陶瓷框架结构冷却之后,可用包含磷酸钙(例如羟基磷灰石)的滑泥浆包涂它的支柱,使多余的滑泥浆从框架结构中沥去,后一种材料在框架材料上形成涂层。因为纯磷酸钙不能很好地与纯氧化锆结合,理想地是提供包含二种材料组分的插入层。可将所形成的材料再次加热,以便驱除滑泥浆溶剂,并且如果需要,同时烧结此羟基磷灰石材料,使其颗粒与另一种材料的颗粒至少部分地融合。在此结构中,所形成的支撑框架结构的空隙从一面至另一面是敞开的,并且第二种骨传导性材料的空隙是彼此连续,相互连通的,而且与支撑框架成分的空隙相互连通(并与它们共同延伸)。
在制备这种制品时,合乎要求的是加热此氧化锆框架成分,使之达到滑泥浆的溶剂基本上被全部驱除并开始部分地烧结的温度。这种状态被称为部分烧结阶段。在此时,可使用羟基磷灰石滑泥浆或组合的氧化锆和羟基磷灰石滑泥浆,加热驱除滑泥浆的溶剂,然后使氧化锆和羟基磷灰石升温至烧结温度,被共同烧结。
在上述此实施方案的一个改良方案中,可对羟基磷灰石滑泥浆加入粘性控制剂和泡沫发生剂如过氧化氢,或者通入压缩气体。当把羟基磷灰石滑泥浆导入氧化锆支撑框架结构时,加热可导致滑泥浆起泡并形成泡沫,以致在羟基磷灰石基质中形成了许多更小的孔隙,羟基磷灰石材料的这些孔隙仍然保持基本上相互连通,连续,并与氧化锆框架结构的孔隙相互连通。
在另一个实施方案中,用于包涂聚合物泡沫胶并产生网格的滑泥浆,含有支撑性框架材料(如氧化锆)和骨传导性材料(如羟基磷灰石)二种组分。用滑泥浆包涂这种网状的聚合物基质,并使多余的滑泥浆沥干。使此制品通过挤压滚筒或用压缩空气冲击制品,可进一步除去多余的滑泥浆。将形成的材料加热驱除溶剂,热解其有机组分,并且共烧结此复合材料的二种成分。在此氧化锆-羟基磷灰石系统中,相对于总的氧化锆/羟基磷灰石体积,骨传导材料(羟基磷灰石)的含量范围优选地高达大约50%的体积,而更优选地是大约10%-25%的体积,使用了足够的骨传导性材料,以致对于生长中的骨能提供一个骨传导性表面。适合的结构可能使用例如25%体积的羟基磷灰石和75%体积的YSZ(氧化钇稳定化的氧化锆)。该网状制品结果是具有由这二种材料的均匀混合物构成的支柱。在氧化锆支柱的表面,羟基磷灰石可能似乎像一些渺小的岛屿。但无论如何,在此实施方案中其骨传导性材料仍然是暴露于制品中的孔道,使之对于正在侵入的骨可提供一种骨传导性作用。
当其框架成分是金属时,可以按照相同于用陶瓷材料框架成分时的方式,构成具有相互连通孔隙的二部分系统,也就是说,可将骨传导性材料掺入支柱内,或者可在金属支柱的壁上包涂,或者使之在此空隙内发生泡沫并被烧结。
可以通过几种方法使本发明的骨代用品材料形成适当的形状,用作骨代用品。在一个优选的方法中。应用普通的切割工具如剪刀,削皮刀(scalpels),和热丝切削刀(hot wire cutter)等,可简便地切割,使具有敞口空隙的有机材料如网状的聚亚胺酯泡沫胶形成所要求的形状。所述任何一种方法成形的泡沫材料,可用于制成本发明的制品。在另一种方法中,是用氧化锆或其它陶瓷滑泥浆包涂如前面所指出的有机泡沫胶,将它加热驱除溶剂并使陶瓷转变成“未成熟”状态,此时可使它成形为所需要的形状。在再一种方法中,可借助于标准的机械方法如锯和磨,喷水或激光切割等,使已完全烧结的本发明骨代用品成形。
如果该制品的支撑框架是金属的,那么可在导入骨传导性或骨诱导性材料之前,通过适当的机械加工使它成为所需要的形状。可设法首先用蜡填充金属材料的孔隙,并使形成的结构凝结,这样在机械加工过程中,蜡可支撑此金属结构,随后驱除蜡只要使蜡熔化。当金属框架成分含有非常薄的壁结构,并具有大的空隙,因此其支柱易被无意弯曲时,这种处理可能特别有用。
在另一实施方案中,本发明的制品包含已加入弹性材料的支撑框架,此框架本身具有比较大的孔道和高度空虚的体积,并附着在一起,因为烧结成了较致密的次级结构成分,它可能是相同或不同的材料,但是它具有较小的孔道和较小的空虚体积。优选的情况是,这种较致密的部分基本上是完全致密的,也就是说,它具有小于10%的空虚体积。此较致密的部分可形成如下各种形状:半管形板材,用于整个髋部和膝部置换的棒材,可用作在长骨髓内道管中可接受的心柱,或者是可用作膝部假肢胫骨托盘的板材等等。后一种材料可形成如棒材或心柱,可用于股骨髋部心柱假肢或胫骨托盘假肢,或者可形成与第一部分相关联的薄层,以致使所形成的结构类似于天然骨,其中第二部分可能像皮质骨-坚硬,致密,作为骨的外层,而其第一部分可能稍微更敞开和多孔,并因此更近似于松质骨。
图4显示了一个股骨髋部假肢杆30,完全用陶瓷制成,此假肢具有致密的杆状部分32,终止在关节球36中的颈角部分34,以及肩角部分38。如在图4中所示,其肩角部分包含本发明制品的厚层40,它具有含较大孔隙的框架,附着在假肢较致密的部分42上。当此假肢被植入伸展的股骨中,包涂层38有助于骨向其内生长。
图4显示了一个胫骨托盘50,它具有超高分子量聚乙烯的上板52,此上板具有关节上表面54。此超高分子量聚乙烯板由本发明致密材料制成的板56支撑,板56与向下伸展的支杆58形成一个整体。以板材60的形式显示了本发明的敞口框架材料,它放置在板56底部形成的向下开口的凹槽62中,此框架材料60向下延伸至大约支杆的上端,如64所示,是较厚的一层,有助于在此区域骨向其内生长。
可借助于任何普通的陶瓷成形技术,制备这种结构的致密部分,如滑泥铸型,带状铸型(tape casting),或者在一种“泡沫胶”的表面包涂和干燥连续的几层滑泥,直至形成一个致密层。干压制,灌注造型和挤压技术也可能是适用的。为了使“未成熟的”致密部分与“未成熟的”低密度部分结合,可通过使用与用于形成低密度部分的滑泥基本类似的组合材料陶瓷滑泥,或者在用于滑泥铸件致密部分时,使用与用于形成致密部分的滑泥基本类似的组合材料陶瓷滑泥。“未成熟的”在此意指陶瓷制品的状态,它已成形并干燥形成了本身的支撑结构,但是还没有从其中除去有机组分。按另一种方式,除了上面列举的材料之外,此致密部分还可以由可再吸收的聚合材料,可再吸收的陶瓷材料或可再吸收的组合材料构成。
在外科手术过程中,例如为了使此制品与骨粘连,可用磷酸钙水泥填充本发明制品的孔隙。当孔隙内的磷酸钙水泥变硬时,可提供对制品的稳固连接。
参照下面非限制性实施例,可能更容易理解本发明:
实施例1
通过组合如下成分,并在聚乙烯容器内使用氧化锆介质,借助于球磨研磨彻底地将它们混匀:
150克 部分稳定化的氧化锆粉末(Zirconia Sales America)
2.25克 分散剂(Rohm and Haas,产品D-3021)
15克 粘合剂(Rohn and Hass,产品标志号B-1000)
0.375克 表面活性剂/湿润剂(Air Products SurfynolTM TG)
0.26克 抗发泡剂(Henkel NopcoTM NXZ)
36ml 去离子水
将每英寸具有10-80个孔隙的网状聚酯-聚亚胺酯泡沫胶片(Stephenson and Lawyer)浸泡于上面的滑泥浆中,反复揉压除去里面的气泡。从滑泥浆中取出泡沫胶,使之沥干多余的滑泥浆。再使此泡沫胶在一对不锈钢挤压滚筒之间通过几次,进一步除去多余的滑泥浆。先在室温下使形成的泡沫胶条干燥,随之以高达100℃的温度在空气中干燥。当此泡沫胶条显示干燥时,再将它们加热,以便热解并除去有机物(粘合剂,分散剂,表面活性剂,抗泡沫剂和网状聚合泡沫胶),然后在大约1400℃的温度烧结1小时。为上述目的,优选的热循环过程包括,以每分钟2℃的速度使泡沫胶条升温至600℃,在600℃保持温度2小时,然后以每分钟5℃的速度升温至1400℃,在此温度保持1小时。然后以每分钟大约10℃的速度使加热炉冷却至室温。
所形成的产品是具有大约76%空虚体积的坚硬,重量轻,多孔的氧化锆框架材料或氧化锆的网络材料。然后用含有氧化锆和羟基磷灰石的滑泥浆包涂此框架结构。如上所述,通过混合和球磨研磨如下成分可制备这种滑泥浆:
75g 部分稳定化的氧化锆(Zirconia Sales America)
12.89g 羟基磷灰石(Plasma Biotal)
1.5g D 3021分散剂
10g B-1000粘合剂
0.25g SurfynolTM TG表面活性剂/湿润剂
0.24g Nopco NXZ抗发泡剂
32ml 去离子水
羟基磷灰石占羟基磷灰石和氧化锆组合体积的25%。
将如上面所述制备的氧化锆条浸泡在此滑泥浆中,并机械搅拌除去气泡,确保滑泥浆完全渗入孔隙中。沥干多余的滑泥浆,并用压缩空气气流进一步除去滑泥浆。使此氧化锆条干燥,然后以每分钟5℃的速度升温至1400℃烧结温度,并在此温度保持1小时。所形成的产品包含坚硬的氧化锆陶瓷框架结构,它的支柱具有由75%体积氧化锆和25%体积羟基磷灰石组成的表面层。此产品的结构显示在图1中,可注意支持氧化锆的支撑框架结构的敞开特性,以及其框架结构和羟基磷灰石的3,3连通性。
如果需要,可对上述结构加入一个或几个附加层。例如在一个实施方案中,将上述结构的标本浸泡于包含大约50%体积氧化锆和羟基磷灰石的滑泥浆中,然后将标本沥干,干燥,并如上面所述在1400℃烧结。
实施例2
此实施例是描述氧化锆-羟基磷灰石组合材料支撑框架结构的制备方法,此框架结构的支柱涂有羟基磷灰石涂层。
制备了二种陶瓷滑泥浆。第一种含有包含15%体积羟基磷灰石的氧化锆,被称为ZHA-15滑泥浆,是用下列成分如实施例1通过球磨研磨制成:
273.99g 部分稳定化的氧化锆
26.01g 羟基磷灰石(HiMed)
3g 聚(环氧乙烷)粘合剂(Acros)
6g 分散剂(DarvanTM C,R.T.Vanderbilt)
0.75g SurfynolTM TG表面活性剂/湿润剂
126ml 去离子水
第二种滑泥浆被称为HA滑泥浆,是用下列成分通过球磨研磨制成:
50g 羟基磷灰石(HiMed)
0.5g 聚(环氧乙烷)粘合剂(Acros)
0.125g SurfynolTM TG表面活性剂/湿润剂
1g 分散剂(DarvanTM C,R.T.Vanderbilt)
76ml 去离子水
将实施例1中的网状聚酯-聚亚胺酯泡沫胶标本,如实施例1用ZHA-15滑泥浆包涂。将此包涂的标本干燥成“未成熟”状态,然后如实施例1加热处理,除去有机物质,并在1400℃烧结。
取决于氧化锆和羟基磷灰石的相对用量,羟基磷灰石可能像在其支柱表面的小“岛”,这显示在图3中。使用足够量的羟基磷灰石或其它骨传导性材料,这样可对支柱表面提供骨传导特性。
冷却之后用HA滑泥浆包涂此标本,然后干燥,加热除去有机物质,并在1400℃烧结。所形成结构的支柱是由含有15%体积羟基磷灰石的部分稳定化氧化锆复合材料核心和羟基磷灰石表面层组成。
实施例3
制备了一种如上面所述的由开放孔道结构组成的“外骨架”结构,其开放的孔道结构结合于致密的支持“板”,此支持板在一个实施方案中是由氧化锆组成,在另一实施方案中是由ZHA-15组成,此开放的孔道结构模拟松质骨,致密的结构模拟皮质骨。
分别使用实施例1的氧化锆滑泥浆和实施例2的ZHA-15滑泥浆,在平板状熟石膏表面作氧化锆和ZHA-15的支持板滑泥浆铸型。在湿滑泥浆被铸型之后,立即将如在实施例2中所制备的ZHA-15的未成熟网状结构置于每种实施方案的湿滑泥浆中。将所形成的标本干燥,加热,当它们达到“半干”状态时对此板部分进行修整。先在空气中干燥,然后在烤箱内100℃的温度干燥。进一步加热此标本,以便除去有机物质,并将每种标本在1400℃烧结成为一个整体。冷却之后,将每种标本模拟松质骨的多孔部分用ZHA-15滑泥浆进行再包涂。用压缩空气除去多余的滑泥浆,使标本再干燥之后在1400℃烧结1小时。形成的每个标本都显示出类似于松质骨的高度多孔部分,它稳固地被结合于类似于皮质骨的较致密的板状部分,显示在图4中。
实施例4
通过组合和混匀下列成分制备了含羟基磷灰石的悬液:
20g 羟基磷灰石
18ml 含1%泡沫胶稳定剂的水溶液(LatticeTM NTC,FMC
Corp)
18ml 3%过氧化氢溶液
如实施例1制备氧化锆标本并烧结,形成一种内骨架性框架,并用此羟基磷灰石悬浮液填充这种框架的孔道。以每小时10℃的速度升温至80℃加热此标本,并在此温度保持2小时。对其中悬液的加热引起过氧化氧分解,释放出氧气泡。这些气泡导致悬液发生泡沫并上升。进一步加热,可使羟基磷灰石泡沫状结构稳定化。将此标本进一步加热除去有机物质,并在1300℃烧结1小时。所形成的结构显示在图2中,此结构包含一种氧化锆框架结构,它具有以高度多孔的羟基磷灰石泡沫胶(大约50%体积的孔隙空间)部分填充的孔道。如所显示,氧化锆框架结构的空隙或孔道保持开放和未堵塞状态,并且氧化锆框架结构的孔道与泡沫状羟基磷灰石涂层的孔隙相连通。
尽管已描述了本发明的优选实施方案,但应该理解的是,在不脱离本发明原理和所附权利要求范围的情况下,可以作出多种改变,应用和改进。
Claims (29)
1.一种可用作骨代用品材料的坚固的多孔性制品,它具有限定整个体积形状的外表面,该制品包含被烧结的连续、坚固支撑性承受负荷的框架结构,此结构具有分隔许多贯穿整个体积相互连通空隙的支柱,该制品还包括由此支撑框架结构携带的多孔性骨传导组合物,所述制品具有延伸贯穿整个体积并开放通向外表面的相互连通的孔道,所述骨传导性组合物暴露于这些相互连通的孔道。
2.权利要求1的制品,其中所述的骨传导性组合物延伸贯穿其整个体积。
3.权利要求1的制品,其中所述支撑框架结构的相互连通的空隙终止在外表面,并且其中的骨传导性组合物从所述形态的外表面向内部延伸,但是不贯穿此形态的整个体积。
4.权利要求1的制品,其中所述的骨传导性组合物是作为连续的涂层被携带在所述的支柱上。
5.权利要求1的制品,其中所述的骨传导性组合物包含与支撑框架结构空隙连通的,但不与它们共同延伸的孔隙。
6.权利要求1的制品,其中所述的支撑框架结构具有整个制品体积至少50%的空虚体积。
7.权利要求1的制品,其中所述的支撑框架结构包含掺入支柱的骨传导性组合物。
8.权利要求1的制品,在所述孔道内包含磷酸钙骨质水泥。
9.权利要求1-6中任何之一的制品,包含一种附着于其整个体积表面,并具有孔隙度不大于10%的致密的结构成分。
10.权利要求9的制品,其中所述的结构成分包括一种棒材,可用作在长骨髓内导管中可接受的心柱。
11.权利要求9的制品,其中所述的结构成分包括一种板材,可用作膝部假肢的胫骨托盘。
12.权利要求1-8中任何之一的制品,其中所述的支撑框架结构是陶瓷。
13.权利要求1-8中任何之一的制品,包含一种由所述结构携带并暴露于所述空隙的骨传导性材料。
14.权利要求1的制品,它具有限定整个体积形状的外表面,该制品包含含有氧化锆的,被烧结的连续、坚固支撑性承受负荷的框架结构,此框架结构具有分隔许多贯穿整个体积的相互连通空隙的支柱,该制品还包括由此支撑框架结构携带的多孔性骨传导组合物,所述制品具有延伸贯穿整个体积并开放通向外表面的相互连通的孔道,所述骨传导性组合物暴露于这些相互连通的孔道。
15.权利要求14的制品,其中所述的支撑框架结构包含一种陶瓷骨传导性组合物,它沿着所述的支柱分布于不连续的位置,并暴露于所述的相互连通的孔道。
16.权利要求14的制品,其中所述的骨传导性组合物,是作为在所述支柱上形成的连续的涂层被携带,并且其中所述的支撑框架结构和骨传导性组合物具有3-3连通性。
17.权利要求15或16的制品,其中所述的陶瓷骨传导性组合物包含磷酸钙化合物。
18.形成一种根据权利要求1所述的制品的方法,该制品是可用作骨代用品的陶瓷制品,该陶瓷制品具有限定整个体积形状的外表面,还具有开放的,延伸贯穿整个体积并开放通向此外表面的相互连通的孔道,该方法包括提供一个有机物的开放性孔隙结构,用陶瓷滑泥浆包涂此结构的孔隙表面,热解有机物结构以便遗留下陶瓷结构,此陶瓷结构具有分隔许多相互连通空隙的支柱,还包括在所述空隙内提供一种暴露于相互连通孔道的多孔性骨传导组合物。
19.权利要求18的方法,包括烧结此陶瓷结构的步骤。
20.权利要求19的方法,其中所述的烧结步骤是在向所述相互连通的空隙内提供骨传导性组合物之前进行。
21.权利要求19的方法,其中所述的烧结步骤是在向所述相互连通的空隙内提供骨传导性组合物之后进行。
22.权利要求19的方法,包括在用陶瓷滑泥浆包涂其孔隙之前,使所述有机物的开放性多孔结构成形为预定形状的步骤。
23.权利要求19的方法,包括在用陶瓷滑泥浆包涂其孔隙之后,使所述有机物的开放性多孔结构成形为预定形状的步骤。
24.形成一种可用作骨代用品的陶瓷制品的方法,该陶瓷制品具有限定整个体积形状的外表面,还具有开放的,延伸贯穿整个体积并开放通向此外表面的相互连通的孔道,该方法包括提供一个有机物的开放性孔隙结构,用陶瓷滑泥浆包涂此结构的孔隙表面,此结构包含坚固的陶瓷支撑材料和分隔的骨传导性材料,该方法还包括热解有机物结构以便遗留下陶瓷结构,此陶瓷结构具有分隔许多相互连通空隙的支柱,还包括烧结此陶瓷结构,使其骨传导性材料暴露于相互连通的孔道。
25.权利要求24的方法,包括将磷酸钙骨质水泥注入所述孔道的步骤。
26.一种可用作骨代用品材料的坚固的多孔性制品,它具有限定整个体积形状的外表面,并具有延伸贯穿整个体积并开放通向外表面的相互连通的孔道,该制品包含被烧结的连续、坚固支撑性承受负荷的框架结构,此框架结构具有分隔许多贯穿整个体积的相互连通空隙的支柱,该制品还包含由此支撑框架结构携带的第一种多孔的骨传导性组合物,以及由此第一种多孔的骨传导性组合物携带的,并暴露于所述相互连通孔道的第二种多孔的骨传导性组合物。
27.权利要求26的制品,其中所述的第一种和第二种多孔的骨传导性组合物各自包含骨传导性材料,第二种组合物中的骨传导性材料浓度大于第一种组合物中的浓度。
28.权利要求26的制品,它具有限定整个体积形状的外表面,并具有延伸贯穿整个体积并开放通向外表面的相互连通的孔道,该制品包含含有氧化锆的,被烧结的连续、坚固支撑性承受负荷的框架结构,其支柱分隔许多贯穿整个体积的相互连通的空隙,该制品还包含由此支撑框架结构携带的含有羟基磷灰石的第一种多孔的骨传导性组合物,以及由此第一种组合物携带的,并暴露于所述相互连通孔道的第二种多孔的骨传导性组合物,所述第二种组合物包含的羟基磷灰石浓度大于第一种组合物包含的浓度。
29.权利要求28的组合物,其中所述的第一种和第二种多孔的骨传导性组合物包含氧化锆。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US08/942,557 | 1997-10-01 | ||
US08/942,557 US6136029A (en) | 1997-10-01 | 1997-10-01 | Bone substitute materials |
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CN1290181A CN1290181A (zh) | 2001-04-04 |
CN1230207C true CN1230207C (zh) | 2005-12-07 |
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CN98811730.4A Expired - Fee Related CN1230207C (zh) | 1997-10-01 | 1998-09-30 | 骨代用品材料 |
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US (1) | US6136029A (zh) |
EP (1) | EP1024840B1 (zh) |
JP (1) | JP4101458B2 (zh) |
CN (1) | CN1230207C (zh) |
AU (1) | AU736513B2 (zh) |
CA (1) | CA2305431C (zh) |
DE (1) | DE69824876T2 (zh) |
WO (1) | WO1999016479A1 (zh) |
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JP4101458B2 (ja) | 2008-06-18 |
AU9594198A (en) | 1999-04-23 |
AU736513B2 (en) | 2001-07-26 |
CA2305431C (en) | 2009-09-08 |
US6136029A (en) | 2000-10-24 |
WO1999016479A1 (en) | 1999-04-08 |
EP1024840A1 (en) | 2000-08-09 |
CA2305431A1 (en) | 1999-04-08 |
DE69824876T2 (de) | 2005-07-14 |
JP2001518322A (ja) | 2001-10-16 |
DE69824876D1 (de) | 2004-08-05 |
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