CN102245220B - 物品及物品表面处理方法 - Google Patents
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- 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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- A61F2/00—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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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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- A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
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Abstract
一种物品,包括:衬底;以及设于所述衬底至少部分表面上的羟磷灰石外涂层,和粘接所述衬底和所述外涂层的中间粘接层,其中,所述衬底与所述外涂层之间设有机械联锁。
Description
技术领域
本发明涉及假体装置等物品上的涂层,特别是矫形植入物上的涂层。
背景技术
随着世界范围的人口老龄化,对生物医学植入物的需求增加。在英国,2003年进行了43,000例髋关节置换术(英国国家***2003年报告),使患者可以移动,缓解了患者的痛苦,相信将来这个数字将会持续增加。
生物医学嵌入物的使用同样在增加。嵌入物可为临时置入人体的物品。例如,导管和支架(stent)均为嵌入物。
本申请涉及用于人体或动物体的嵌入物或植入物,特别涉及这种嵌入物或植入物上的生物材料涂层。生物材料指与人体组织相容的材料。即,人体不排斥的材料。生物材料可为陶瓷、金属、聚合物或这些材料的组合。引起人们兴趣的一种特殊的生物材料是羟磷灰石(HA)。
在保健产业,羟磷灰石(HA)被广泛用作涂层材料,以将其良好的生物特性与传统金属植入材料的极佳的机械性能结合。HA使用量为天然骨组织矿物的60-70%。它具有骨传导性,因为它可促进与骨组织的直接结合。
有多种HA涂敷技术,包括等离子喷涂、浸渍涂布、溅射和脉冲激光沉积,近来采用静电雾化喷射沉积。等离子喷涂是商业上制造HA涂层使用最多的方法;涂层厚度在30μm至200μm间变化。但是,过程控制非常复杂。HA经受的高处理温度使可溶磷酸钙化合物产生分解。另外,快速冷却产生非晶涂层。浸渍涂布技术用于制备厚度为0.05mm至0.5mm的HA涂层。这是一种廉价快速的技术,并能在复杂形状的衬底上制造涂层,但浸渍涂布要求较高的烧结温度,这会引起HA发生脱羟基作用。溅射涂布和脉冲激光沉积技术能在平坦衬底上制造均匀厚度的涂层;厚度可控制为0.02μm至5μm。但是,采用这种方法制造的薄涂层相对昂贵,且大部分为非晶形。溅射涂布和脉冲激光沉积均无法在复杂形状的衬底上制造涂层。
WO2004/103423公开了一种具有权利要求1前序部分特点的植入物。
需要提供一种具有羟磷灰石涂层的物品,该涂层可良好地粘接在衬底的表面。特别地,需要提供一种可覆盖复杂形状物品的方法。
发明内容
本发明提供一种嵌入物或植入物,包括:衬底;以及设于所述衬底至少部分表面上的生物材料外涂层,和粘接所述衬底和所述外涂层的中间粘接层,其中,所述中间粘接层在平面图中具有第一区域和第二区域,所述第一区域的厚度大于第二区域的厚度,并且所述第一区域和第二区域在平面图中形成图案,以在所述中间粘接层与所述外涂层之间提供机械联锁。
本发明进一步提供一种嵌入物或植入物的至少部分表面的表面处理方法,所述方法包括:在所述嵌入物或植入物的至少部分表面沉积中间粘接层和生物材料外涂层,使所述中间粘接层粘接衬底和所述外涂层,所述中间粘接层沉积为在平面图中具有第一区域和第二区域,所述第一区域的厚度大于第二区域的厚度,并且所述第一区域和第二区域在平面图中形成图案,以在所述中间粘接层和所述外涂层之间提供机械联锁。
附图说明
现参考附图,仅以示例的目的对本发明的实施例进行说明,其中:
图1a为本发明采用的模板辅助电流体动力雾化(TAEA,Template-AssistedElectrohydrodynamic Atomization)喷涂方法的示意图;
图1b示出了本发明的(TAEA)过程采用的接地电极的配置;
图2为涂敷了中间粘接层的一个实施例的衬底表面的扫描电子显微镜(SEM)显微照片;
图3为涂敷了中间粘接层的另一个实施例的衬底表面的扫描电子显微镜(SEM)显微照片;
图4为涂敷于具有图2所示配置的中间层的外涂层的扫描电子显微镜(SEM)显微照片;
图4b为涂敷于具有图3所示配置的中间层的外涂层的扫描电子显微镜(SEM)显微照片;
图5a为扫描电子显微镜(SEM)显微照片,该图片显示本发明的羟磷灰石外涂层为人体成骨细胞(HOB)提供有利的结合部位;以及
图5b为扫描电子显微镜(SEM)显微照片,该图片显示人体成骨细胞在特定方向上在本发明的涂层上对准。
具体实施方式
本发明的以下示例涉及的生物材料为羟磷灰石(HA)。但是,其他生物材料同样适用于本发明。生物材料指适用于植入人体的材料。即,置入人体时,对人体无害的材料。生物材料包括:聚合物:聚甲基丙烯酸(PMMA)、聚乙烯(PE)、聚二甲基亚砜(PDMS)、聚丙烯(PP)、聚砜(PS)、聚碳酸酯(PC)、聚乙醇酸(PGA)、聚乳酸(PLA)、聚己内酯(PCL)、聚二氧杂环己酮(PDS)、聚羟基丁酸酯(PHB)、聚原酸酯、聚(2-羟基-乙基-甲基丙烯酸酯)(PHEMA)。生物陶瓷:羟磷灰石(HA)、非晶相(ACP)、α-磷酸三钙(a-TCP)、β-磷酸三钙(B-TCP)、磷酸四钙(TTCP)、氧化羟磷灰石(OHA)、取代磷酸钙、生物活性玻璃和生物活性玻璃陶瓷(具体参阅:Hench L.L.,1998,‘生物陶瓷’,美国陶瓷学会会志('Bioceramics',J.Am.Ceram.Soc.)81,1705-28)。
还可使用复合生物材料。这些材料包括陶瓷金属、陶瓷-陶瓷(ceramic-ceramic)、陶瓷聚合物和金属聚合物复合物。本发明中形成外涂层的生物材料并不限于特定类型。
电流体动力雾化(EHDA)是一种简单经济的工艺,该工艺能够制造具有良好形貌的均匀涂层。该技术已用于在金属衬底上沉积磷酸钙涂层。所述工艺装置由接地电极和连接在高压电源上的喷嘴(喷针)组成。由流率受控的泵向喷嘴提供液体悬浮液或陶瓷悬浮液。流动介质处于喷嘴和接地电极之间的外加电压产生的电场下,并产生延长射流,延长射流随后脱离液体本体,分散成微滴。产生的射流和微滴可分为不同的喷涂模式,这些喷涂模式由喷射的几何形状控制。在多种不同模式中,锥射流模式为最稳定的喷涂模式,可调节射流的分散,以形成尺寸为几微米的微小均匀微滴。微滴从针尖移动到目标衬底上,从而形成沉积。关于EDHA的更多信息,请参阅以下文章:(1)S.C.GLeeuwenburgh,J.G.C Wolke,J.Schoonman和J.A.Jansen(2003)磷酸钙涂层的静电喷射沉积(ESD),生物医学材料研究(Electrostatic spray deposition(ESD)ofcalcium phosphate coatings.Biomed.Mater.Res),A66A,330-334;(2)A.Jaworek和A.Krupa(1996),EHD喷涂进动模式的生成与特性,气溶胶科学杂志(Generation and characteristics of the precession mode of EHD spraying.J.Aerosol.Sci),27,75-82;(3)A.Jaworek和A.Krupa(1999),EHD喷涂模式的分类,气溶胶科学杂志(Classification of the modes of EHD spraying.J.Aerosol.Sci),30,873-893。
对用于生物医学应用领域的物质表面上的三维(3-D)表面结构处理进行了研究,众所周知,三维表面结构的处理可对初始生物响应产生影响。蚀刻、喷墨印刷和电流体动力三维印刷等技术被广泛利用以制造三维生物材料。但是,这些技术受材料物理特性的限制,或技术上较为繁琐。例如,蚀刻一般用于在相对可延展的材料,例如聚合物和金属材料上形成有序表面结构。很难将蚀刻技术用于具有化学稳定性的脆性陶瓷,例如HA。目前,使用印刷技术形成精密的小尺寸表面结构仍然很困难。印刷的三维图案一般为几百微米,与成骨细胞的尺寸(~40μm)相比,量值过高。因此,基于对电流体动力雾化(EHDA)喷涂的研究,新近开发了一种新型图案形成技术,称为模板辅助电流体动力雾化(TAEA)喷涂,并用于nHA图案形成工艺。关于TAEA的更多信息,可参阅以下文章:X.Li,J.Huang和M.J.Edirisinghe(2007),纳米生物陶瓷的新型图案形成技术:模板辅助电流体动力雾化喷涂,皇家学会交叉杂志(Novelpatterning of nano-bioceramics:template-assisted electrohydrodynamic atomizationspraying.J.Royal.Soc.Interface),5,253-257。
EHDA和TAEA技术均具有多种优点,例如易于控制较大均匀区域的覆盖,成本低,设置简单,与微制造(micro-fabrication)技术兼容,并适用于工业生产。界面稳定性对材料的机械性能起决定性作用。
为了增强复合材料的性能,可使用机械联锁提高两种不同物质之间的界面粘接性,从而提高界面稳定性。形成表面纹理是实现界面机械联锁的有效方法。可通过喷砂处理(grit blasting)或湿法蚀刻技术实现粗糙化,这些技术通过在短时间内应用强酸而形成蚀坑,但这些技术存在多个缺点。表面呈现任意形貌,可能会削弱上层的粘接增强。另外,由于粗糙化工艺期间遗留了不良离子,在临床实践中,湿法蚀刻技术可能导致衬底腐蚀。此外,在工业规模生产中,衬底表面形貌难以控制。多项调查表明,在涂敷工艺之前将衬底表面粗糙化可大大提高涂层的粘接性。某些研究显示,HA涂层的粘接性也可通过采用化学粘接而增强。已发现,预涂敷在钛衬底上的连续二氧化钛缓冲层可大大增强HA/Ti的界面粘接性,从而提高临床实践中HA的机械稳定性。
在本发明中,我们将这两种粘接增强概念结合。所述衬底形成有中间粘接层的图案,以改变表面纹理,随后用HA涂敷。这个新的中间粘接层与衬底上的HA涂层联锁。因此,机械联锁和化学粘接均提高了临床实践中植入材料的功能特性(即,提高了粘接性)。化学粘接力可包括牵引力或范德华力。机械联锁也可设于衬底和中间层之间。例如,可在形成中间粘接层之前将衬底粗糙化,从而将所述中间粘接层粘接在衬底上。所述粘接可为化学粘接和/或机械联锁粘接。
所述衬底可为钛、钛合金、不锈钢(优选316L)或钴铬钼合金等。所述衬底形成有中间粘接层图案,优选地,所述中间粘接层包括二氧化钛、二氧化锆(锆)、钛酸钙,或其他复盐、例如三氧化二铁或所述衬底材料和外层材料的复合物。所述羟磷灰石外涂层沉积之前,所述中间粘接层具有非平面表面形貌。即,所述中间粘合层上形成有图案,在平面图中具有相对较厚的第一区域和相对较薄的第二区域。
可通过在衬底上喷射材料微滴,涂敷所述中间粘接层。可利用势差将微滴吸引到衬底上。所述中间粘接层可以任何方式形成图案。例如,可通过蚀刻基本平面层、喷墨印刷所述中间粘接层或用电流体动力三维印刷方法印刷中间粘接层,来沉积所述中间粘接层并形成图案。优选地,采用TAEA涂敷所述中间粘接层,这样可精确控制中间层的表面形貌,解决了现有技术中提供表面纹理的方法的至少某些缺点。在该方法中,通过模板喷射材料微滴,从而涂敷所述中间粘接层。利用势差将所述微滴通过模板吸引到衬底上。
优选地,所述中间粘接层与衬底之间和/或与羟磷灰石之间的粘接强度大于衬底与羟磷灰石之间的粘接强度。这样,所述中间粘接层的存在使羟磷灰石与衬底之间产生更强的化学粘接。
羟磷灰石可以任何方式涂敷,特别地,可以微滴的形式涂敷。优选采用EHDA涂敷羟磷灰石。在该过程中,利用势差将材料微滴吸引到衬底上。
在一个实施例中,所述中间粘接层内部具有通孔,使所述外涂层与衬底及中间粘接层接触。在一个实施例中,所述中间粘接层的最小厚度为0μm至10μm。即,所述第二区域从无到有变化(厚度从0μm至高达10μm)。在使用钛衬底的情况下,例如,天然二氧化钛层的厚度约为125nm。因此,优选最小厚度为125nm或200nm至10μm。在一个实施例中,所述中间粘接层的最大厚度(例如,第一区域的厚度)为0.2μm至30μm,优选为0.5μm至20μm。因此,相对于彼此,所述第一区域相对较厚,第二区域相对较薄。所述中间层第一区域和第二区域之间的厚度差为0.2μm至30μm。已发现,这个厚度差提供了充分的机械联锁;即使200nm的厚度差也有助于粘接。比较而言,虽然所述外涂层的形貌与中间层的形貌一致,但其厚度变化范围仅为0μm至5μm。所述外涂层的厚度为0.1μm至100μm,优选为0.5μm至50μm。所有层的总厚度范围为0.1μm至200μm,优选为0.5μm至50μm,更优选为1μm至25μm。这可通过采用EHDA实现。
只要所述中间粘接层实现了预期的机械联锁,其图案并不重要。为了易于制造,优选地,可提供基本规则图案(在平面图中(in plan)),其中第一区域和第二区域具有不同高度。例如,所述规则图案可为一系列正方形或其它形状紧密堆积(例如,六边形或三角形)。在另一个实施例中,所述图案包括多条平行线。在另一个实施例中,可在平面图中形成圆形图案。不同图案可产生更强的联锁。优选使用接触导向图案。接触导向图案是植入物或嵌入物处于人体或动物体内时可进行细胞定位的一种图案。已发现,由于细胞较好地粘接在植入物或嵌入物上,使细胞定位有利于细胞生长。例如,如果在骨植入物上使用接触导向图案,优选地,会产生骨雕刻(sculpturing)。Adam Curtis等在“生物材料(Biomaterials)”18(1997)1573-1583中对接触导向现象进行了详细描述。接触导向图案可包括上述特定形状中的任一种。
优选地,相邻第一区域的间隔为5μm至80μm(中心到中心)。在一个实施例中,相邻第二区域的间隔为5μm至100μm(中心到中心)。
下文将对本发明实施例的详细示例进行说明。
实验程序
1.材料
1.1二氧化钛溶胶
将异丙氧化钛(IV)、四异丙醇钛(Ti[OCH(CH3)2]4)(西格玛奥德里奇,普尔(Sigma-Aldrich,Poole),英国)用作前驱体。将2wt%的前驱体转移到含有乙醇的气密瓶中,制备二氧化钛溶胶,将合成溶液在环境条件下用磁力搅拌器搅拌3个小时。使用气密瓶的目的在于防止使用前产生任何蒸发或污染。使用~2wt%前驱体获得的溶胶(sol)非常稳定,长时间静置不会产生沉淀。
1.2HA悬浮液
通过氢氧化钙和正磷酸(均来自英国BDH公司)之间的湿沉淀反应合成HA。在室温连续搅拌下向0.5M氢氧化钙溶液滴加0.3M正磷酸,同时添加氨溶液,使pH保持在10.5以上。将获得的沉淀物进一步老化两个星期,然后用沸水冲洗。将老化的nHA粒子添加到乙醇中,制备6wt%悬浮液,以适用于电流体动力流(electrohydrodynamic flow)工艺。其他文章对HA粒子和悬浮液的悬浮液制备和表征进行了详细说明(例如,Huang等,材料科学杂志(Journal ofMaterials Science)39(2004)1029-1032;以及Huang等,材料科学杂志(Journalof Material Science):医学材料(Materials in Medicine)15(2004)441-445)。
2.采用TAEA进行二氧化钛图案形成工艺
该工艺中使用的TAEA设备的布局如图1a所示。使用的不锈钢喷针的内径为~300μm。将制备的新鲜二氧化钛溶胶注射到流率为10μl/min的喷针内,喷针和接地电极之间的外加电压最高为6kV,观察电流体动力喷涂情况。如图1b所示,TAEA工艺过程采用特别设计的接地电极配置。在钛衬底的顶部放置硅晶圆(silicon wafer)。不锈钢喷针和衬底之间的距离固定为40mm。用P4000碳化硅磨光纸打磨工业纯钛衬底板,随后用丙酮和乙醇进行清洁。喷涂时间控制为60秒。图案形成期间使用具有不同几何形状的多种模板遮蔽钛衬底。
3.采用EHDA进行HA涂敷工艺
HA喷涂工艺使用的EHDA喷涂设备的配置布局与前述TAEA喷涂的设备配置布局相似(图1a)。唯一区别为接地电极的配置。具有二氧化钛图案的钛衬底不是用硅晶圆覆盖,而是直接接地。将制备的新鲜的6%wtHA悬浮液注入流率为20μl/min的喷针。衬底与喷针之间的距离也设为40mm。外加电压最高为6kV,以实现稳定的锥射流模式。HA喷涂时间控制为60秒。
4.表征
使用光学显微镜和场发射扫描电子显微镜(SEM,JEOLJSM/6301F)检测二氧化钛图案的形貌和与二氧化钛联锁的HA涂层的形貌以确定微观结构。SEM的工作距离为15mm,加速电压设为15kV。还使用人体成骨细胞(HOB)进行初步细胞培养,以将与二氧化钛联锁的线形HA涂层的生物活性进行表征。使用设有LED二极管激光器的莱卡(Leica)SPII共焦显微镜进行HOB细胞定位的可视化,以激活405nm的赫斯特(Hoechst)33258荧光团。
结果
如图2所示,使用正方形模板制备了分布在钛表面上的方形岛内的二氧化钛粒子。所述岛的宽度控制为42μm,标准偏差为4μm,岛之间的间隔为48μm,标准偏差为4μm。使用磨光钛衬底上的平行模板,同样在钛衬底上制备线形二氧化钛图案,如图3所示。线宽为13μm,标准偏差为3μm,线之间的间隔为65μm,标准偏差为3μm。制备的所有二氧化钛图案均表现出均匀有序的形貌。岛之间的间隔保持恒定,仅相差几微米;通过使用相同模板和相同工艺参数,使整个涂层中岛的形状和尺寸保持相同。进行了TAEA图案形成工艺之后,随后进行EHDA喷涂工艺,以在联锁层上制备生物活性HA层。如图4所示,整个HA涂层表现出均匀连续的形貌,并形成光学显微图像。可清楚地从图中看出,方形和线形“山丘”有序地分布在HA涂层中。进行了初步体外(in-vitro)研究,以表征具有线形联锁层的新型HA涂层的生物活性。如图5所示,荧光共焦显微图像显示了制备的表面上培养的HOB细胞的鉴别染色核结构和细胞骨架结构。在图5a的放大图像显示,HA表面为HOB细胞的附着提供了有利的结合部位。观察到HOB细胞的大量结合区域。这肯定地表明,新制备的HA涂层支持HOB细胞的附着和粘着。另外,如图5b所示,HOB细胞不是随机分布,而是在特定方向上对准。这种现象表明,具有联锁层的HA涂层可支持细胞附着,由于其特定的表面形貌,还可进一步引导细胞定位。
Claims (16)
1.一种嵌入物或植入物,包括:
衬底;以及
设于所述衬底至少部分表面上的生物材料外涂层,和粘接所述衬底和所述外涂层的中间粘接层,其特征在于,所述中间粘接层在平面图中具有第一区域和第二区域,所述第一区域的厚度大于第二区域的厚度,并且所述第一区域和第二区域在平面图中形成图案,以在所述中间粘接层与所述外涂层之间提供机械联锁,
其中,所述嵌入物为临时置入人体的物品。
2.根据权利要求1所述的嵌入物或植入物,其特征在于,所述中间粘接层内部具有通孔,使所述外涂层与所述衬底及所述中间粘接层接触。
3.根据权利要求1所述的嵌入物或植入物,其特征在于,所述第一区域和第二区域之间的厚度差为0.2μm至30μm。
4.根据权利要求1、2或3所述的嵌入物或植入物,其特征在于,所述第一区域和第二区域形成接触导向图案,当所述嵌入物或植入物处于人或动物体内时,所述接触导向图案产生细胞定位。
5.根据权利要求1、2或3所述的嵌入物或植入物,其特征在于,所述第一区域和第二区域在平面图中形成规则图案。
6.根据权利要求1、2或3所述的嵌入物或植入物,其特征在于,所述衬底为钛、钛合金、不锈钢或钴铬钼合金。
7.根据权利要求1、2或3所述的嵌入物或植入物,其特征在于,所述中间粘接层包括二氧化钛、二氧化锆、钛酸钙、复盐、三氧化二铁、或所述衬底材料和外层材料的复合物。
8.根据权利要求1所述的嵌入物或植入物,其特征在于,所述生物材料为选自由以下材料组成的组中的一种材料:聚合物、生物陶瓷、生物活性玻璃、生物活性玻璃陶瓷、复合陶瓷金属、复合陶瓷聚合物、复合金属聚合物。
9.根据权利要求8所述的嵌入物或植入物,其特征在于,所述生物材料为选自由以下材料组成的组中的一种材料:聚甲基丙烯酸、聚乙烯、聚二甲基亚砜、聚丙烯、聚砜、聚碳酸酯、聚乙醇酸、聚乳酸、聚己内酯、聚二氧杂环己酮、聚羟基丁酸酯、聚原酸酯、聚(2-羟基-乙基-甲基丙烯酸酯)、羟磷灰石、无定形磷酸钙、α-磷酸三钙、β-磷酸三钙、磷酸四钙、氧化羟磷灰石、取代磷酸钙。
10.一种嵌入物或植入物的至少部分表面的表面处理方法,所述方法包括:
在所述嵌入物或植入物的至少部分表面沉积中间粘接层和生物材料外涂层,使所述中间粘接层粘接衬底和所述外涂层,其特征在于,所述中间粘接层沉积为在平面图中具有第一区域和第二区域,所述第一区域的厚度大于第二区域的厚度,并且所述第一区域和第二区域在平面图中形成图案,以在所述中间粘接层和所述外涂层之间提供机械联锁。
11.根据权利要求10所述的方法,其特征在于,通过在所述衬底上喷射材料微滴,涂敷所述中间粘接层。
12.根据权利要求11所述的方法,其特征在于,通过模板喷射材料微滴,从而涂敷所述中间粘接层。
13.根据权利要求12所述的方法,其特征在于,利用势差将所述微滴通过所述模板吸引到所述衬底上。
14.根据权利要求11、12或13所述的方法,其特征在于,采用模板辅助电流体动力雾化方法涂敷所述中间粘接层。
15.根据权利要求11所述的方法,其特征在于,所述外涂层沉积之前,所述中间粘接层具有非平面表面形貌。
16.根据权利要求15所述的方法,其特征在于,通过蚀刻基本平面层、喷墨印刷所述中间粘接层或用电流体动力三维印刷方法印刷所述中间粘接层,形成所述表面形貌。
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PCT/GB2009/002788 WO2010063993A2 (en) | 2008-12-01 | 2009-11-30 | Article and method of surface treatment of an article |
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EP (1) | EP2361100B1 (zh) |
CN (1) | CN102245220B (zh) |
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WO2010063993A2 (en) | 2010-06-10 |
EP2361100A2 (en) | 2011-08-31 |
CN102245220A (zh) | 2011-11-16 |
US20120064290A1 (en) | 2012-03-15 |
US9044528B2 (en) | 2015-06-02 |
GB0821927D0 (en) | 2009-01-07 |
AU2009323851A1 (en) | 2011-07-14 |
WO2010063993A3 (en) | 2010-12-09 |
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CA2780697A1 (en) | 2010-06-10 |
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