CN101808677A - 具有陶瓷涂布表面的制品 - Google Patents
具有陶瓷涂布表面的制品 Download PDFInfo
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Abstract
根据本发明的一个方面,提供了包含衬底和覆盖所述衬底表面至少一部分的陶瓷涂层的制品。所述陶瓷涂层包括由陶瓷层连接的凸起陶瓷壳,所述陶瓷层与所述衬底共形。根据本发明的另一个方面,提供了碳纳米管,其包含覆盖所述碳纳米管至少一部分的陶瓷涂层。
Description
技术领域
本发明涉及包括医疗制品的制品,所述制品具有陶瓷涂布表面。
背景技术
使制品设有陶瓷表面,以用于多种用途。因此,持续要求新型的陶瓷涂布制品和制造所述制品的方法。
发明内容
根据本发明的一个方面,提供了包含衬底和陶瓷涂层的制品,所述涂层覆盖所述衬底表面的至少一部分。所述陶瓷涂层包括由底部陶瓷层连接的凸起陶瓷壳,所述底部陶瓷层与衬底共形(conformal)。可以将所述壳进行部分或全部填充,或者它们可以为中空的。
根据本发明的另一个方面,提供了碳纳米管,其包含覆盖所述碳纳米管的至少一部分的陶瓷涂层。
对于本领域普通技术人员而言,通过下列具体实施方式和所附的权利要求书,本发明的上述和其它方面以及各个实施方案和优点会立即变得显而易见。
附图说明
图1A为现有技术的支架(stent)的示意性透视图。图1B为沿图1A的线b-b截取的示意性剖视图。
图2A和2B为本发明两个实施方案的支架支柱(stent strut)的示意性剖视图。
图3A为本发明实施方案具有陶瓷涂层的制品的示意性剖视图。
图3B和3C为本发明陶瓷涂层的SEM图像。
图4A和4B为本发明两个实施方案具有陶瓷涂层的制品的示意性剖视图,所述制品还包含聚合物层。
图4C为显示用于形成与图4B类似的聚合物层的方法的示意性剖视图。
图5A~5G为显示本发明各个实施方案具有陶瓷涂层的制品和形成所述制品的方法的示意性剖视图。
图6A和6B为本发明两个实施方案的制品的示意性剖视图。
图7A~7H、8A~8C和9A~9D为显示本发明各个实施方案的制品和形成所述制品的方法的示意性剖视图。
图10A~10C为显示形成本发明陶瓷涂布的碳纳米管的方法的示意性剖视图。
图11为本发明实施方案的陶瓷涂层的SEM图像。
具体实施方式
根据本发明的方面,提供包含衬底和覆盖所述衬底表面至少一部分的陶瓷涂层的制品。所述陶瓷涂层包括由底部陶瓷层连接的凸起陶瓷壳,所述底部陶瓷层与所述衬底共形。所述壳可以部分或全部填充,或者它们可以为中空的。如下面更加详细描述的,在特定实施方案中,陶瓷涂层构成了在整个衬底表面上延伸的单一陶瓷结构。
如本文中所使用的,给定材料的“层”为厚度比其长度和宽度小的所述材料区域。例如,长度和宽度各自可以为厚度的至少5倍,例如独立地为厚度的5~10~30~100~300~1000倍以上。如本文中所使用的,所述层不需要平坦,例如呈现底层衬底的轮廓。因此,本文中所述的陶瓷壳为层。层能够为不连续的(例如经构图的)。
如本文中所使用的,“陶瓷区域”例如陶瓷层或陶瓷壳为含有单一陶瓷物种或两种以上不同陶瓷物种的混合物的材料区域。例如,本发明的陶瓷区域典型地包含例如10wt%以下~25wt%~50wt%~75wt%~90wt%~95wt%~95wt%以上的一种以上陶瓷物种。因此,本发明的陶瓷区域能够包含陶瓷物种以外的物种,例如在某些实施方案中,包含1wt%以下~2wt%~5wt%~10wt%~25wt%~50wt%以上的聚合物物种。
其中,用于陶瓷区域的陶瓷物种包括金属和半金属氧化物、金属和半金属氮化物以及金属和半金属碳化物。金属和半金属氧化物、氮化物和碳化物的实例包括元素周期表14族半金属(例如Si、Ge)的氧化物氮化物和碳化物,以及过渡金属和非过渡金属如3族金属(例如Sc、Y)、4族金属(例如Ti、Zr、Hf)、5族金属(例如V、Nb、Ta)、6族金属(例如Cr、Mo、W)、7族金属(例如Mn、Tc、Re)、8族金属(例如Fe、Ru、Os)、9族金属(例如Co、Rh、Ir)、10族金属(例如Ni、Pd、Pt)、11族金属(例如Cu、Ag、Au)、12族金属(例如Zn、Cd、Hg)、13族金属(例如Al、Ga、In、Tl)、14族金属(例如Sn、Pb)、15族金属(例如Bi)的氧化物氮化物和碳化物。其中,例如使用高温碳热还原和氮化方法可以形成金属和半金属氧化物的碳化物和氮化物。
在图3A的横截面中示意性显示了本发明制品的一个实例,其中显示了由陶瓷涂层320覆盖的衬底310,所述陶瓷涂层320包括由共形陶瓷层320c连接的凸起陶瓷壳320s。陶瓷壳320s的内部350如所示为中空的。能够使共形陶瓷层320c非常薄(例如100nm以下),因此能够随底层衬底容易地变形(例如折曲或弯曲)。而且,能够将陶瓷壳320均匀隔开(参见图3),使得它们在温和弯曲/折曲期间不会相互啮合。所述陶瓷壳320s的高度能够变化几个数量级,并且取决于用作模板来形成壳的粒子的尺寸,如下面进一步进行讨论。
图3B为与图3A中示意性显示的类似结构的SEM。图3C为单个凸起陶瓷壳的SEM。其为破裂的,表明其是中空的。试样与试样之间的表面粗糙度不同可能是由几个参数引起的,这些参数包括底层衬底的粗糙度以及加工偏差。尽管在观察SEM时其不明显,但是覆盖衬底的陶瓷层和球体的陶瓷壳是连续结构,如图3A中示意性所示。
在图3A~3C中,陶瓷壳为球形。然而,如下面进一步讨论,陶瓷壳能够呈现接近无限的形状范围,其取决于用于形成所述壳的模板粒子。在图3A~3C中,内部陶瓷壳是中空的。然而,利用材料的接近无限的排列能够部分或全部地填充所述陶瓷壳的内部,在其它材料中,所述材料包括金属、聚合物、陶瓷和前述材料的组合(混合物),这取决于用于形成壳的模板粒子,并取决于在加工期间是否全部或部分地将模板粒子除去。作为一个具体实例,在许多其它可能性中,陶瓷壳可以包含碳纳米管(例如提供机械加强等)。
本发明可应用于实际上陶瓷涂层有用的任意制品,只要涂布衬底与所使用的加工条件相容。涂布制品包括具有陶瓷涂层的制品,所述涂层设有或不设有壳结构,且在设有壳结构时,所述壳结构可以为中空的或含有加强粒子(例如碳纳米管等)。可以因各种原因而设置这类涂层,其中所述原因包括耐腐蚀性、耐磨损性、光学性质、抗病毒和抗菌性质(例如锐钛矿TiOx涂层等)和光敏行为。在许多其它制品中,制品的实例包括下列内容:可以涂布有陶瓷层的汽车部件,包括完整的汽车框架;气体、油、其它侵蚀性化学介质的传输管道内部;光催化和光电制品(例如通过在聚合物衬底上形成光敏陶瓷涂层如锐钛矿涂层);航空和航天制品(例如飞机、航天飞机、火箭等的外部面板);金属火器部件;窗(例如根据本发明形成的纳米厚度的涂层可以充当反射涂层等);门把手(doorknobs and door handles);电话;铺地瓷砖;乙烯基壁纸;塑料钞票(例如用于特定国家如澳大利亚的那些钞票);硬币;家具,包括在公共场合中发现的家具;座椅(例如在汽车、火车和公共火车中);栏杆,包括楼梯栏杆和自动扶梯的橡胶手扶带;聚合物基儿童玩具(包括学校、托儿所等中所使用的那些制品);和ATM机上的小键盘。
在特定实施方案中,涂布制品为医疗制品。医疗制品包括外用于身体的制品如用于向完整皮肤和破损皮肤(包括伤口)传送治疗剂的补丁以及可植入或可插入装置,所述可植入或可插入装置例如为支架(包括冠状血管支架(vascular stent)、周围血管支架、大脑、尿道、输尿管、胆管、气管、胃肠和食道支架)、支架覆盖物、支架移植物、血管移植物、腹部主动脉瘤(AAA)装置(例如AAA支架、AAA移植物)、血管入口、渗析口、导管(例如泌尿导管或血管导管如气囊导管和各种中央血管导管)、导丝、气囊、过滤器(例如用于蒸馏保护装置的腔静脉过滤器和筛网过滤器)、包括大脑动脉瘤填料线圈(包括Guglilmi可拆卸线圈和金属线圈)的栓塞装置、隔膜缺陷闭合装置、适用于放置在动脉中以用于治疗相对于装置的动脉末梢部分的药物仓、心肌塞(myocardial plug)、补丁、起搏器、包括起搏器导线的导线、心脏除颤导线和线圈,包括左心室辅助心脏和泵的心室辅助装置,全部人工心脏,分流器,包括心脏瓣膜和血管瓣膜的瓣膜,吻合夹和环,耳蜗植入物,组织隆起装置,和用于软骨、骨头、皮肤和其它活体内组织再生的组织工程支架,在外科手术位置处的缝合线、缝合线固定器、组织卡钉和绑扎夹,插管,金属线绷带,尿道吊带,疝气“筛眼”,人工韧带,整形外科假体如骨移植物、骨板、臂和融合装置,关节假体,整形外科固定装置如在踝、膝和手部区域中的界面螺钉,用于韧带附件和半月板修补的钉,用于骨折固定的棒和销,用于颅颌面修补的螺钉和板,牙齿植入物,或植入或插入身体内的其它装置。
本发明的装置包括例如用于身体组织治疗的可植入和可插入医疗器械,以及用于局部治疗受治疗者的任意组织或器官的那些装置。非限制性实例为肿瘤;器官,其包括心脏、冠状和周围血管系统(总体上称作“脉管系统”),泌尿生殖器系统,其包括肾脏、膀胱、尿道、输尿管、前列腺、阴道、子宫和卵巢,眼睛,耳朵,脊骨,神经系统,肺,气管,食道,肠,胃,脑,肝和胰,骨骼肌,平滑肌,胸部,皮肤组织,软骨,牙齿和骨头。如本文中所使用的,“治疗”是指防止疾病或不适(diseace or condition),降低或消除与疾病或不适相关的症状,或者基本上或完全消除疾病或不适。“受治疗者”包括有脊椎的受治疗者,例如人类、家畜和宠物。
本发明的医疗器械包括各种可植入和可插入的医疗器械,其用于插入和/或通过宽范围的体腔,其中,几个体腔已经在上面做了介绍,其包括心血管系统如心脏、动脉(例如冠状动脉、股动脉、主动脉、髂动脉、颈动脉和椎-基底动脉)和静脉的腔,泌尿生殖系统如尿道(包括前列腺尿道)、膀胱、输尿管、阴道、子宫、输精管和输卵管的腔,鼻泪管,耳咽管,呼吸道如气管、支气管、鼻孔和鼻窦的腔,胃肠道如食道、肠、十二指肠、小肠、大肠、直肠的腔,胆管和胰管系统,淋巴系统的腔,和主体腔(腹膜、胸膜、心包)。
本发明能够设有陶瓷涂层的医疗器械衬底可以例如与整个医疗器械(如金属支架)或仅与医疗器械的一部分相对应(例如与医疗器械的元件、粘附至医疗器械或装置元件的材料等相对应)。
为了说明本发明,现在结合血管支架对本发明的几个示例性实施方案进行描述。然而,本发明绝不限于支架,或者甚至医疗制品,如上面所看到的。
作为背景,例如在气囊成形术之后,经常开处方将冠状支架如商购得自波士顿科学公司(Boston Scientific Corp.)(TAXUS和PROMUS)、强生公司(Johnson & Johnson)(CYPHER)和其它厂家的那些支架用于保持血管开放。这些产品以具有生物稳定的聚合物涂层的金属气囊可膨胀支架为基础,其可以以受控速率和总剂量释放抗增殖治疗剂,以防止血管再狭窄。例如在图1A和1B中示意性显示了一种这样的装置。图1A为支架100的示意性透视图,所述支架100含有大量连通的支柱(strut)101。图1B为图1A支架100的支柱101的沿线b-b而截取的横截面,且显示了不锈钢支柱衬底110和含治疗剂的聚合物涂层120,聚合物涂层120封装整个支架支柱衬底110,从而覆盖其腔表面(luminalsurface)1101(血液侧)、离腔表面(abluminal surface)110a(血管侧)和侧面110s。
尽管期望将这种支架的离腔表面设有能够释放抗增殖药物以对抗再狭窄的聚合物涂层,但是不可能同样期望这种药物存在于支架的腔表面上。如果仅向支架的离腔表面施加聚合物涂层,则期望在支架表面和聚合物涂层之间具有良好的粘附性,因为仅通过其包围支架支柱的事实已不会将聚合物固定至支架。没有足够的粘附性,例如在支架传输期间,可能会发生涂层与支架表面的分层。
而且,即使在支架表面和聚合物涂层之间具有良好的粘附性,在软聚合物涂层的情况下,作为与支架从其传送管滑动除去有关的高剪切力的结果,涂层尽管如此也可能会从自膨胀支架的表面磨去。
另一方面,在支架的腔表面上所期望的为促进快速形成功能性内皮细胞层的表面,已知这对降低或消除在脉管系统内植入外来物体时能够发生的炎症和血栓症的目的是有效的。参见例如J.M.Caves et al.,J.Vasc.Surg.(2006)44:1363-8。
其中,使用本发明的陶瓷涂层可以实现一个以上上述目的,在某些实施方案中,如上所述的陶瓷涂层包括由陶瓷层连接的凸起陶瓷壳(其可以为中空的,或者部分或全部被各种固体材料所填充)。
例如,现在参考图2A,其为支架支柱201的示意性剖视图,在支架支柱衬底210的腔表面210l、离腔表面210a和侧面210s上方设置本发明的陶瓷涂层220。在陶瓷涂层220上设置药物洗脱的聚合物层230,但仅在支架支柱衬底210的离腔表面210a的上方(而不在腔210l和侧面210s上方)。作为另一个实例,参考图2B,在支架支柱衬底210的腔表面210l、离腔表面210a和侧面210s上方再次设置本发明的陶瓷涂层220,而在支架支柱衬底210的离腔表面210a和侧面210s上方设置药物洗脱的聚合物层230,但不在腔表面210l上方。应当注意,在任一实施方案中,如果用于聚合物涂层230中的聚合物为生物可分解的,则聚合物最终与陶瓷涂层留在体内,所述陶瓷涂层选自生物学惰性或生物活性的各种材料(例如二氧化钛、氧化锆、氧化铱等)。
关于致力于上述目的,本发明的陶瓷涂层220,特别是陶瓷结构包含多个陶瓷壳的那些实施方案,例如通过增加聚合物涂层230和底层陶瓷涂层220之间的界面表面积(即在缺少陶瓷结构220的条件下,相对于另外存在于聚合物涂层230和衬底210之间的界面表面积)而促进了聚合物涂层的粘附。另外,本发明的陶瓷涂层以较小或较大的程度与相邻的聚合物涂层230互锁。
参考图4,能够更好地看到这一点,所述图4A为在其上布置了本发明陶瓷涂层420的衬底410(例如在大量其它可能性中,支架支柱)的示意图。所述涂层420包括由陶瓷层420c连接的凸起陶瓷壳420s,所述陶瓷层420c与所述衬底410共形。如上所述,凸起陶瓷壳420s和陶瓷层420c构成单个陶瓷结构。显示了布置在陶瓷涂层420上方的聚合物涂层430。由于在陶瓷壳420s下方的底切,所以聚合物涂层430在一定程度上与陶瓷涂层420互锁。从图7H和8C(下面进一步描述)看出,能够形成这样的陶瓷涂层,其能够在本发明的陶瓷涂层和覆盖在其上的聚合物层之间产生更大程度的互锁。
关于本发明的陶瓷涂层保护聚合物涂层的能力(例如抵抗剪切力、磨损等),参考图4B能够看到一种这样的实施方案,图4B与图4A类似,为在其上布置了本发明陶瓷涂层420的衬底410的示意图,所述陶瓷涂层420包括由陶瓷层420c连接的凸起陶瓷壳420s,所述陶瓷层420c与所述衬底420共形。显示了布置在陶瓷涂层420上方的聚合物涂层430。然而,与图4A不同,聚合物涂层430基本上不会延伸超出凸起陶瓷壳420s高度。因此,陶瓷壳420s能够保护聚合物涂层430例如不会因磨损、剪切力等而被擦掉。
在图4C中示意性显示了与图4B类似的制造聚合物涂层430的方法的一个实例。在用粘性聚合物溶液430v覆盖陶瓷涂层420c、420s之后,在结构上运行刮刀(图4C中显示了三个刮刀450,所述三个刮刀以与三刃剃刀相类似的方式排列)。陶瓷壳420s限制了刮刀450能够接近陶瓷层420c的程度。因此,产生了这样的聚合物层,其基本上具有与陶瓷壳420s相同的高度。因为在包含在其中的溶剂蒸发时粘性聚合物溶液430v会释放体积,所以如果需要,可以重复所述过程,以增加最后聚合物层的厚度。当然,在聚合物涂布过程中能够使用其它液体聚合物组合物,其包括聚合物熔融物和可固化的聚合物组合物。
因此,在与支架一起使用时,与图4B中所示类似的陶瓷涂层使得软聚合物涂层受到保护免受机械力,而不影响支架的机械品质。关于后面的优点,用于保护聚合物涂层免受机械力损害的另一种选择是在支架表面内形成凹陷,其将屏蔽聚合物涂层。然而,能够装载入这些凹陷内的聚合物涂层(和由此的治疗剂)的量限于除去的材料的量,大量除去材料潜在地弱化支架。
与图4B中所示类似的陶瓷涂层的另一个优点在于,所述涂层使得可以非常好地控制含任何治疗剂的聚合物层的高度和总体积,因此控制了治疗剂含量。更特别地,涂层高度取决于球形壳的高度,这通过初始模板粒子(即聚苯乙烯球)的尺寸来限定,能够以优于2.0%的尺寸变化得到初始模板粒子。必须考虑球所占的体积。然而,这能够通过考虑球形壳的直径和平均密度而完成,所述球形壳均匀分散在表面上,如从图3B中能够看出。
关于提供促进快速形成功能性内皮细胞层的支架表面的目的,容易地形成了具有微米级和/或纳米级特征的本发明的陶瓷涂层,已经广泛报导了其促进如下所述的细胞附着和/或细胞增殖。在这点上,能够制造具有广泛的各种形状和尺寸的形貌特征的陶瓷涂层。表面特征的宽度通常为小于100微米(μm),例如为100微米以上~50微米~25微米~10微米~5微米~2微米~1微米~500nm~250nm~100nm~50nm~25nm以下。如下所述,用作产生陶瓷壳的模板的粒子决定表面特征的形状和尺寸。
如上所述,据报道,由表面上发现的织构影响表面上的细胞附着和/或细胞生长(增殖)两者。例如,文献显示,在织构表面上培养的内皮细胞扩展更迅速并且看起来更像天然动脉内的细胞。参见R.G.Flemming et al.,Biomaterials 20(1999)573-588。据报道,织构的表面促进了稳定的假新内膜的形成。在这点上,N.Fujisawa et al.,Biomaterials20(1999)955-962发现,在绵羊颈动脉中植入时,在平滑的基底表面上由规则间距、凸出的微纤维(在纤维基底的长度、间距和直径分别为250、100和25μm)构成的织构聚氨酯表面促进了稳定血栓基础的形成,在其上随后细胞迁移和组织愈合比在平滑表面上更快地发生。其他人注意到,通过在表面上产生良好限定的微型织构图案,在表面处的流体流动发生变化,从而产生低剪切应力的离散区域,其可以充当细胞如内皮细胞的避难所并促进它们的保持。参见S.C.Daxini et al.“Micropatterned polymer surfaces improve retention of endothelial cellsexposed to flow-induced shear stress(微型构图的聚合物表面改进了暴露于流动诱导的剪切应力的内皮细胞的保持)”,Biorheology 2006 43(1)45-55。
已经观察到了低于100nm范围内的织构增加了细胞附着和/或增值。参见例如E.K.F Yim et al.的评论文章,“Significance of syntheticnanostructures in dictating cellular response(合成纳米结构在决定细胞响应方面的重要性)”,Nanomedicine:Nanotechnology,Biology,andMedicine 1(2005)10-21,其报导了平滑的肌肉细胞和内皮细胞改进了在纳米构图的表面上的细胞附着和增值。两种细胞都对纳米形貌敏感。不期望被理论束缚,相信小于100nm的特征尺寸使得蛋白如纤连蛋白、层粘连蛋白和/或玻连蛋白粘附至纳米织构的表面上,并为这些蛋白提供了构象(conformation),所述构象更好地暴露了氨基酸序列如RGD和YGSIR,其增强了内皮细胞结合。参见例如Standard handbook ofbiomedical engineering and design(生物医学工程和设计的标准手册),Myer Kutz,Ed.,2003 ISBN 0-07-135637-1,p.16.13。此外,纳米织构增加了表面能,据信这增加了细胞粘附。参见例如J.Y.Lim et al.,J.Biomed.Mater.Res.(2004)68A(3):504-512。在这点上,已经在主动脉瓣膜内皮的基底膜和其它基底膜材料中观察到了亚微米形貌,其包括低于100nm范围内的孔、纤维和高地。参见R.G.Flemming et al.,Biomaterials 20(1999)573-588、S.Brody et al.,Tissue Eng.2006Feb;12(2):413-421和S.L.Goodman et al.,Biomaterials 1996;17:2087-95。Goodman等人使用聚合物铸造物以复制裸露和扩张血管的内皮下细胞外基体表面的形貌特征,他们发现,在这种材料上生长的内皮细胞比在未进行织构的表面上生长的细胞扩展得更快速并且看起来更像它们天然动脉内的细胞。
现在将描述可以用于产生与图3A-3C中所示类似的结构的方法的实例。这种方法是以层叠加工和溶胶-凝胶加工的组合为基础的。例如在由Frank Caruso编辑的“Colloids and Colloid Assemblies(胶体和胶体组件)”,Wiley-VCH,ISBN 3-527-30660-9,pp.266-269;D.Wang and F.Caruso,“Polyelectrolyte-Coated Colloid Spheres as Templates for Sol-GelReactions(作为溶胶-凝胶反应模板的聚电解质-涂布的胶体球)”,Chem.Mater.2002,14,1909-1913;D.Wang et al.,“Synthesis ofMacroporous Titania and Inorganic Composite Materials from CoatedColloidal Spheres A Novel Route to Tune Pore Morphology(由涂布的胶体球合成大孔二氧化钛和无机复合材料:调整孔形态的新途径)”,Chem.Mater.2001,13,364-371;和Caruso的WO 02/074431中,能够发现关于层叠/溶胶-凝胶加工的信息。
作为背景,已知根据带电材料的静电自组装,在衬底上能够形成多层涂层,所述方法通常称作层叠(LBL)法。在LBL法中,典型地在底层衬底(在本发明中为医疗器械衬底或其一部分)上沉积具有第一表面电荷的第一层,然后形成具有与第一层的表面电荷符号相反的第二表面电荷的第二层等。在沉积各个顺序层时,反转较外层的电荷。通常,以这种技术施用5~10~25~50~100~200个以上的层,这取决于期望的多层结构的厚度。LBL技术通常使用称为“聚电解质”的带电物种,其为具有多个带电基团的聚合物。典型地,带电基团数目如此大,以致聚合物当处于离子解离的形式(也称作聚离子)时溶于极性溶剂(包括水)中。根据带电基团的类型,可以将聚电解质分为聚阳离子(其通常衍生自多酸及其盐)或聚阴离子(其通常衍生自多碱及其盐)。在许多其它材料中,聚阴离子/多酸的具体实例包括聚(苯乙烯磺酸盐)(PSS)(例如聚(苯乙烯磺酸钠))、聚丙烯酸、聚乙烯硫酸盐、聚乙烯磺酸盐、海藻酸钠、丙烯酸树脂(eudragit)、明胶、透明质酸、角叉菜胶、硫酸软骨素和羧甲基纤维素。在许多其它材料中,聚阳离子/多碱的具体实例包括鱼精蛋白硫酸盐、聚(烯丙胺)(例如聚(烯丙胺盐酸盐)(PAH))、聚二烯丙基二甲铵物种、聚乙烯亚胺(PEI)、聚乙烯胺、聚乙烯吡啶、壳聚糖、明胶、亚精胺和清蛋白。关于LBL法的其它信息,参见例如Weber等人的US 2005/0208100和Chen等人的WO/2005/115496。
另外熟知,使用溶胶-凝胶加工技术可以形成陶瓷区域。在典型的溶胶-凝胶法中,在形成陶瓷材料中,对前体材料进行水解和缩合反应,所述前体材料典型地选自无机金属和半金属盐、金属和半金属络合物/螯合物、金属和半金属氢氧化物及有机金属和有机半金属化合物如金属醇盐和烷氧基硅烷。通常,将选择的半金属或金属(例如硅、铝、锆、钛、锡、铁、铪、钽、钼、钨、铼、铱等)的选择的醇盐(例如甲醇盐、乙醇盐、异丙醇盐、叔丁醇盐等)溶于合适溶剂如一种以上醇中。随后,添加水或另一种水溶液如酸或碱的水溶液(所述水溶液能够还含有有机溶剂物种如醇),从而引发水解和缩合发生。基本上认为所述溶胶-凝胶反应为陶瓷网络形成过程,如在下列得自G.Kickelbick,“Prog.Polym.Sci.,28(2003)83-114中的简化方案所示:
水解:
缩合:
2M(OR)n-m(OH)m→(RO)n-m(HO)mM-O-M(OR)n-m(OH)m
M=Si、Ti、Zr、Sn、Al……
R=Me、Et、iPr、nPr、nBu、sbu……
其中,所述陶瓷相内金属/半金属原子(通常表示为M)显示为通过共价键如M-O-M键相互连接,尽管在网络内还通常存在其它相互作用,其包括例如因羟基如残余M-OH基团的存在而形成的氢键。不管确切机理,对所谓的“溶胶”(即固体粒子在液体中的悬浮体)的进一步加工,能够以各种不同形式制造固体材料。例如,通过喷涂、利用涂布器(例如辊子或刷子)进行的涂布、喷墨印刷、丝网印刷等,能够制造湿“凝胶”涂层。然后,将所述湿凝胶进行干燥以形成陶瓷区域。例如在G.Kickelbick supra and Viitala R.et al.,“Surface properties of in vitrobioactive and non-bioactive sol-gel derived materials(在体外的生物活性和非生物活性溶胶-凝胶衍生材料的表面性质)”,Biomaterials,2002Aug;23(15):3073-86和Helmus等人的公布US 2006/0129215的部分中,能够发现关于溶胶-凝胶材料的其它信息。
现在参考图5A~5F,对形成本发明结构的方法进行描述。
在第一步骤中,使用LBL法在衬底510上形成聚电解质多层(PML)涂层512。在这点上,将特定衬底内在带电,由此易于使得它们进行层叠组装技术。虽然如此,可以提供表面电荷,直至衬底不具有内在网络表面电荷的程度。例如,在涂布的衬底导电时,可以通过向所述衬底上施加电位而提供表面电荷。作为另一种实例,可以利用各种试剂对衬底进行化学处理,所述衬底包括金属和聚合物衬底,所述试剂包括还原剂和氧化剂(例如用于形成磺酸盐的三氧化硫),所述试剂对其表面进行改性,以向它们提供带电基团,在其它许多基团中,所述带电基团例如为氨基、磷酸根、硫酸根、磺酸根、膦酸根和羧酸根基团。提供表面电荷的其它技术包括利用反应性等离子体对表面区域进行处理的技术。通过将表面暴露在部分电离的气体(即等离子体)获得表面改性。因为等离子体相由广谱反应性物种(电子、离子等)构成,所以已经广泛使用这些技术来使得表面官能化,其中所述表面包括聚合物表面。实例包括辉光放电技术(其在减压下进行)和电晕放电技术(其在大气压下进行),在某些情况下优选前者,因为在辉光放电过程期间,处理物体的形状不是很重要。还可以使用激光以在激光束附近(例如刚好在光束焦点之上)产生局部等离子体。当使用气体如一氧化碳(CO)、二氧化碳(CO2)或氧气时,通常观察到利用-COOH基团(其供给质子而形成阴离子基团)的官能化。当使用气体如氨气、丙胺或N2/H2时,通常形成-NH2基团(其接受质子而形成阳离子基团)。另外,使用等离子体聚合法可以获得含官能团的表面,其中使用含官能团的“单体”。基于该目的,使用烯丙胺(其产生-NH2基团)和丙烯酸(其产生-COOH基团)。通过使用第二进料气体(其通常为非聚合性单体)与不饱和单体的组合,可以在等离子体沉积层中并入该第二物种。气体对的实例包括烯丙胺/NH3(其导致强化产生-NH2基团)和丙烯酸/CO2(其导致强化产生-COOH基团)。例如在“Functionalization of Polymer Surfaces(聚合物表面的官能化)”,Europlasma Technical Paper,05/08/04和公布的US 2003/0236323号中,可以发现关于等离子体加工的其它信息。作为另一个实例,可以首先使用基于等离子体的技术如上述那些技术,以使得衬底表面官能化,然后通过将表面例如在惰性气氛或真空中暴露于激光束下以除去表面的一部分官能团,从而最小化沉积。作为还另一个实例,使用本领域中熟知的方法,通过与具有正电荷(例如胺、亚胺或其它碱性基团)或负电荷(例如羧酸、膦酸、磷酸、硫酸、磺酸和其它酸性基团)的官能团的物种共价偶联,能够为衬底提供电荷。例如在公布的US 2005/0002865号中,可以发现关于共价偶联的其它信息。在许多实施方案中,简单地通过将聚阳离子或聚阴离子吸附到衬底表面上作为第一带电层,在衬底上提供表面电荷。基于该目的,通常使用PEI,因为其大大促进了对各种衬底的粘附。在Atanasoska等人的序号11/322905中,能够发现其它信息。
不考虑为给定衬底提供表面电荷的方法,一旦提供了足够的表面电荷,能够容易地将衬底涂布有带相反电荷的材料层。这类层的实例包括含有(a)聚电解质、(b)带电粒子或(c)聚电解质和带电粒子两者的层。通过交替暴露在含带相反电荷的材料的溶液中,形成多层区域。所述层利用静电层叠沉积进行自组装,由此在衬底上形成多层区域。
利用各种技术可以施用聚电解质溶液(和含粒子的溶液)。其中,这些技术包括例如全浸技术如浸渍技术、喷射技术、辊涂或刷涂技术、借助于机械悬浮如空气悬浮的涂布技术、喷墨技术、旋涂技术、网涂技术和这些方法的组合。还可以使用压印,例如在S.Kidambi et al.,“Selective Depositions on Polyelectrolyte Multilayers:Self-AssembledMonolayers of m-dPEG Acid as Molecular Templates(在聚电解质多层上的选择性沉积:作为分子模板的m-dPEG酸的自组装单层)”J.Am.Chem.Soc.126,4697-4703,2004和Park et al.,“Multilayer TransferPrinting for Polyelectrolyte Multilayer Patterning:Direct Transfer ofLayer-by-Layer Assembled Micropatterned Thin Films(聚电解质多层构图的多层转印:层叠组装的微构图薄膜的直接转印),Adv.Mater.”,2004,16(6),520-525中所述。
技术的选择取决于目前的要求。例如,期望向整个衬底、包括视图所隐藏表面(例如通过视线(line-of-sight)技术如喷射技术不能到达的表面)上施加物种时,可以使用沉积或全浸技术。另一方面,当期望仅向衬底的特定部分(例如在衬底一侧上、在衬底上以图案的形式等)施加物种时,例如可以使用喷射、辊涂、刷涂、喷墨印刷和微聚合物压印。
现在转向图5A,例如通过在相反电荷的连续聚电解质区域中进行浸渍,将衬底510设置所示的PML涂层512。根据衬底所暴露的最后溶液是否为聚阳离子溶液或聚阴离子溶液,确定该方法结束时多层聚电解质涂层512的表面电荷。在某些实施方案中,在这点上,在如下所述的聚电解质层内进行溶胶-凝胶型过程。
在其它实施方案如图5B~5C中所示的实施方案中,将选择的粒子吸附到表面上。典型地,使用带电粒子,所述带电粒子本身带电或例如使用一种上述技术进行充电。例如,可以将粒子暴露于PEI溶液中以产生带负电荷的粒子。如果需要,通过将离子暴露于含相反电荷的聚电解质溶液中,能够反转粒子上的电荷。在某些实施方案中,可以使用粒子的溶液,其中所述粒子设有聚电解质多层涂层。例如使用诸如上述的那些技术(例如浸渍等),可以将衬底暴露于带电粒子的悬浮液中。将该步骤的结果示于图5B中,所述图5B示意性显示了医疗器械衬底510、PML涂层512和带电粒子515。然后,将图5B的结构进一步浸入交替电荷的聚电解质溶液中以将带电粒子515包封在PML涂层512中。该过程还增加了预先施加到衬底510上的聚电解质涂层的厚度。将该过程的结果示于图5C中。
在某些实施方案中,使用带电的治疗剂以形成一层以上的PML涂层512。由“带电的治疗剂”表示具有相关电荷的治疗剂。例如,治疗剂可以具有相关电荷,因为其本身带电(例如因为其具有酸性和/或碱性基团,其可以为盐的形式)。治疗剂可以具有相关电荷,因为其已经进行了化学改性而为其提供了一种以上带电官能团。
例如,最近为了溶解药物(在有些情况下为了提高肿瘤目标命中(targeting)并降低药物毒性),已经进行包括抗肿瘤试剂如紫杉醇的水不溶或难溶的药物与亲水性聚合物的共轭。类似地,也已经开发了水不溶或难溶的药物的阳离子或阳离子版本。以紫杉醇作为具体实例,已知该药物的各种阳离子形式,包括紫杉醇N-甲基吡啶甲磺酸盐和与N-2-羟丙基甲酰胺共轭的紫杉醇,作为紫杉醇的各种阴离子形式包括紫杉醇-聚(1-谷氨酸)、紫杉醇-聚(1-谷氨酸)-PEO。参见例如美国专利6730699号;Duncan et al.,Journal of Controlled Release,74(2001)135;Duncan,Nature Reviews/Drug Discovery,Vol.2,May 2003,347;J.G.Qasem et al,AAPS PharmSciTech 2003,4(2)Article 21。除了这些文献以外,美国专利6730699号也描述了与各种其它带电聚合物(例如聚电解质)共轭的紫杉醇,所述带电聚合物包括聚(d-谷氨酸)、聚(d1-谷氨酸)、聚(1-天冬氨酸)、聚(d-天冬氨酸)、聚(d1-天冬氨酸)、聚(1-赖氨酸)、聚(d-赖氨酸)、聚(d1-赖氨酸)、上述聚氨基酸与聚乙二醇的共聚物(例如紫杉醇-聚(1-谷氨酸)-PEO)、以及聚(2-羟乙基1-谷氨酰胺)、壳聚糖、羧甲基葡聚糖、透明质酸、人体血清蛋白和藻酸。紫杉醇的另外其它形式包括羧化形式如1′-malyl紫杉醇钠盐(参见例如E.W.DAmen et al.,“Paclitaxel esters of malic acid as prodrugs with improved watersolubility(作为水溶解度提高的前药的苹果酸的紫杉醇酯)”,Bioorg.Med.Chem.,2000Feb,8(2),pp.427-32)。由Cell Therapeutics,Inc.,Seattle,WA,USA制造了聚谷氨酸紫杉醇,其中通过2位上的羟基将紫杉醇连接至聚-L-谷氨酸(PGA)的Δ羧酸。(7位上的羟基也可以用于酯化。)据说,这种分子通过组织蛋白酶B在体内发生解离,以释放二谷氨酰基紫杉醇。在这种分子中,紫杉醇沿聚合物骨架连接至一部分羧基上,导致每个分子中有多个紫杉醇单元。关于其它信息,参见例如R.Duncan et al.,“Polymer-drug conjugates,PDEPT and PELT:basicprinciples for design and transfer from the laboratory to clinic(聚合物-药物共轭物、PDEPT和PELT:设计和从实验室向临床转化的基本原理)”,Journal of Controlled Release 74(2001)135-146;C.Li,“Poly(L-glutamicacid)-anticancer drug conjugates(聚(L-谷氨酸)-抗癌药物共轭物)”,Advanced Drug Delivery Reviews 54(2002)695-713;Duncan,NatureReviews/Drug Discovery,Vol.2,May 2003,347;Qasem et al,AAPSPharmSciTech 2003,4(2)Article 21;和美国专利5614549号。
使用上述和其它策略,可以将紫杉醇和大量其它治疗剂与各种带电物种进行共价连接或以其它方式连接,所述带电物种包括带电聚合物分子(例如聚电解质),由此形成能够在PML方法中进行组装的带电药物和前药。在施用之前或施用时,这种带电物种可以适用于从药物/或前药中解离(例如因酶解离等)。
在接下来的步骤中,在聚电解质层中进行溶胶-凝胶过程。例如,可以在无水溶剂如无水醇中对图5C的结构进行洗涤。除了保持吸附在PML涂层512内的水,这种操作基本上将所有的水从所述结构中除去。然后,将所述结构浸入溶胶-凝胶前体溶液中。例如,可以将所述结构浸入半金属或金属醇盐在无水醇溶剂或具有高醇含量的水-醇溶剂(即水的浓度太低而不会发生水解-缩合反应的溶剂)中的溶液中。不希望受操作理论束缚,据信聚电解质基团的高电荷密度引起PML涂层512具有比周围溶胶-凝胶前体溶液的水浓度高的水浓度(例如,通过在无水溶剂中洗涤期间,吸引水分子离开溶胶-凝胶前体溶液和/或保持水分子)。在扩散入PML涂层512中时,溶胶-凝胶前体遇到提高水浓度的环境,其中能够发生水解和缩合。PML涂层512发生溶胀,因为溶胶-凝胶前体在所述层内的原位反应。然而,电荷密度也因溶胀而降低,从而导致水浓度降低,其最终终止溶胶-凝胶反应。不管确切机理,作为聚电解质/陶瓷混合涂层的所得的涂层厚度均匀,且其厚度取决于聚电解质涂层内层的数目(更多的层导致更厚的涂层)。将所得的结构示于图5D中,所述图5D显示了衬底510、粒子515和聚电解质/陶瓷混合涂层514。
然后,可以将图5D结构加热至例如约150℃~约600℃以上的任何温度,以形成图5E~5G中所示的经热处理的陶瓷涂层520。在所述范围的较高端,陶瓷涂层520具有高比例的陶瓷物种(例如含有90wt%以上的陶瓷物种,例如95wt%~98wt%~99wt%~99.5wt%~99.9wt%以上),在有时称作煅烧的过程中涂层的基本上所有聚电解质组分从结构中脱气。如上所述,所得的壳的厚度通常与在溶胶-凝胶加工之前沉积的聚电解质层的数目成比例。例如,在D.Wang and F.Caruso,Chem.Mater.2002,14,1909-1913中报道,每个聚电解质层的厚度为约1nm。
如上所述,在某些实施方案中,其中例如使用高温碳热还原或氮化方法,可以形成金属和半金属氧化物的碳化物和氮化物。
在所述温度范围的较低端,所述陶瓷涂层520,除了含有陶瓷物种之外,还含有大量聚合物物种(聚电解质)。然而,在这种情况下,热处理将强化陶瓷涂层520。
在另外其它实施方案中,通过水蒸气暴露,可以形成陶瓷涂层。例如,通过将含0~50mol%二氧化硅的溶胶-凝胶衍生的二氧化钛薄膜暴露于在60~180℃的水蒸气中,形成了多孔二氧化钛-基(TiOx-基)锐钛矿涂层。参见H.Imai et al.,J.Am.Ceram.Soc.,82(9),1999,2301-2304。据报道,钛氧化物涂层具有光催化性质和光电效应。另外参见Margit J.Jensen et al.,J.Sol-Gel Sci.Techn.(2006)39:229-233,其报道了纳米结晶锐钛矿(TiO2)膜的制备,其使用异丙醇钛和过氧化氢在乙醇中通过溶胶-凝胶途径在极低温度下制得。在35℃下于饱含水蒸气的大气中的膜沉积之后,发生结晶。在本发明中,能够将这种加工与如上所述形成的溶胶-凝胶溶胀的PML层一起使用。这允许人们例如用非常挠性(因为涂层非常薄)的混合聚合物-陶瓷涂层对聚合物衬底(因为所述条件不会损伤衬底)进行涂布。
其中,在PML结构中设置治疗剂时(参见上述),还可以期望诸如上述那些的较低温度后处理过程,所述治疗剂在更高温度下可能受到损害。
根据热处理温度和气氛,并根据形成图5D粒子515的材料的性质,所述热处理过程或者不会导致粒子形成材料的除去(尽管,在某些情况下导致粒子的化学改性),从而使粒子515如图5E中所示被包围在陶瓷壳520s中,或者,其将导致部分或全部除去粒子形成材料,由此产生具有部分或全部中空的内部517的陶瓷壳520s,如图5F中所示。
粒子除去还可以独立于热处理进行,例如在不进行热处理条件下、在热处理之前或者在热处理之后(其中热处理不会除去粒子)进行。例如,通过溶解过程可以除去粒子。作为具体实例,使用有机溶剂可以除去聚合物粒子(例如通过四氢呋喃除去聚苯乙烯粒子),且使用酸性或碱性水溶液可以除去无机粒子(例如使用HF除去二氧化硅粒子)。
在某些实施方案中,使用混合的模板粒子,其中各种粒子的一部分被除去(例如通过热处理、溶解等)且各种粒子的一部分保留在中空陶瓷壳内。这种粒子的一种实例为聚苯乙烯球,所述聚苯乙烯球含有一种以上更小的顺磁粒子(例如在聚苯乙烯基体内的顺磁粒子,具有聚苯乙烯壳的顺磁粒子核等)。例如通过加热或通过有机溶剂溶解,能够除去这种粒子的聚苯乙烯部分。
现在转向图5G的结构,除了在衬底510上静电沉积带电粒子515且不首先用聚电解质多层涂层涂布衬底510(如在图5A中所实施的)之外,通过与形成图5E类似的方法形成这种结构,结果,在图5G结构中粒子515的结果比图5E的粒子515更接近衬底510。
在某些实施方案中,在衬底的整个表面上设置本发明的陶瓷涂层。在某些实施方案中,仅在衬底的一部分表面上设置本发明的陶瓷涂层(例如仅在腔支架表面、仅在离腔支架表面、仅在离腔和侧支架表面等)。例如通过将所使用的各种溶液(例如聚电解质溶液、粒子溶液、溶胶-凝胶溶液)仅暴露于一部分衬底下,可以部分涂布衬底。在其它技术当中,这样操作的技术的实例包括使用掩膜、部分浸渍、辊涂(例如在期望向管式装置如支架的离腔表面施加涂层时)或其它转印涂布技术,其包括使用合适的施用装置如刷子、辊子、压模或喷墨印刷机。
由于LBL加工的简单特性并由于可以使用各种技术对不带电材料进行充电的事实,可以将宽范围的衬底和粒子材料用于本发明的实践。
因此,合适的衬底材料可以选自多种材料,包括(a)有机材料(例如含有机物种、通常为50wt%以上的有机物种的材料)如聚合物材料;和(b)无机材料(例如含无机物种、通常为50wt%以上的无机物种的材料)如金属材料(例如金属和金属合金)和非金属无机材料(其中,例如碳、半导体、玻璃、金属-和非金属-氧化物、金属-和非金属-氮化物、金属-和非金属-碳化物、金属-和非金属-硼化物、金属-和非金属-磷酸盐及金属-和非金属硫化物)。合适的衬底材料包括生物稳定的材料和生物可分解的材料(即放置在体内时,可以溶解、降解、再吸收和/或从放置位置以其它方式除去的材料)。
其中,非金属无机材料的具体实例例如可以选自含一种以上下列物质的材料:金属氧化物,包括氧化铝和过渡金属氧化物(例如钛、锆、铪、钽、钼、钨、铼和铱以及诸如上述作为陶瓷物种的实例的那些金属的其它金属的氧化物);硅;硅基材料如含氮化硅、碳化硅和氧化硅的材料(有时称作玻璃陶瓷);磷酸钙陶瓷(例如羟基磷灰石);碳和碳基陶瓷类材料如碳氮化物。
其中,金属无机材料的具体实例例如可以选自基本上纯的生物稳定和生物可分解的金属(例如生物稳定的金属如金、铂、钯、铱、锇、铑、钛、钽、钨和钌,和生物可分解金属如镁、锌和铁),及生物稳定和生物可分解的金属合金,例如包含铁和铬的生物稳定金属合金(例如不锈钢,包括富集铂的辐射透不过的不锈钢);含镍和钛的合金(例如镍钛诺(Nitinol));含钴和铬的合金,包括含钴、铬和铁的合金(例如耐蚀游丝合金(elgiloy alloy));含镍、钴和铬的合金(例如MP 35N)和含钴、铬、钨和镍的合金(例如L605);含镍和铬的合金(例如铬镍铁合金(inconel alloy));和生物可分解的金属合金如镁合金、锌合金和铁合金(包括它们相互的组合,以及与其它元素至的Ce、Ca、Zn、Zr和Li的组合,参见Heublein等人的公布的US 2002/0004060号)。
有机材料的具体实例包括生物稳定的和生物可分解的聚合物,例如其可以选自其中的下列材料:聚羧酸聚合物和包括聚丙烯酸的共聚物;缩醛聚合物和共聚物;丙烯酸酯和甲基丙烯酸酯聚合物和共聚物(例如甲基丙烯酸正丁酯);纤维素聚合物和共聚物,包括乙酸纤维素、硝酸纤维素、丙酸纤维素、乙酸纤维素丁酸酯、赛璐玢、人造纤维、人造纤维三乙酸酯和纤维素醚如羧甲基纤维素和羟烷基纤维素;聚甲醛聚合物和共聚物;聚酰亚胺聚合物和共聚物如聚醚嵌段酰亚胺、聚酰胺酰亚胺、聚酯酰亚胺和聚醚酰亚胺;聚砜聚合物和共聚物,包括聚芳基砜和聚醚砜;聚酰胺聚合物和共聚物,包括尼龙6,6、尼龙12、聚醚-嵌段共聚-聚酰胺聚合物(例如树脂)、聚己内酰胺和聚丙烯酰胺;树脂,包括醇酸树脂、酚醛树脂、脲醛树脂、三聚氰胺树脂、环氧树脂、烯丙基树脂和环氧化物树脂;聚碳酸酯;聚丙烯腈;聚乙烯基吡咯烷酮(交联及其它方式);乙烯基单体的聚合物和共聚物,包括聚乙烯基醇,聚乙烯卤化物如聚氯乙烯、乙烯-乙酸乙烯酯共聚物(EVA)、聚偏二氯乙烯,聚乙烯基醚如聚乙烯基甲醚,乙烯基芳族聚合物和共聚物如聚苯乙烯、苯乙烯-马来酸酐共聚物、包括苯乙烯-丁二烯共聚物的乙烯基芳族烃共聚物、苯乙烯-乙烯-丁烯共聚物(例如聚苯乙烯-聚乙烯/丁烯-聚苯乙烯(SEBS)共聚物,得自G的系列聚合物)、苯乙烯-异戊二烯共聚物(例如聚苯乙烯-聚异戊二烯-聚苯乙烯)、丙烯腈-苯乙烯共聚物、丙烯腈-丁二烯-苯乙烯共聚物、苯乙烯-丁二烯共聚物和苯乙烯-异丁烯共聚物(例如聚异丁烯-聚苯乙烯嵌段共聚物如SIBS),聚乙烯基酮,聚乙烯基咔唑,和聚乙烯基酯如聚乙烯基乙酸酯;聚苯并咪唑;离聚物;聚烷基氧化物聚合物和共聚物,包括聚环氧乙烷(PEO);聚酯,包括聚对苯二甲酸乙二醇酯、聚对苯二甲酸丁二醇酯和脂肪族聚酯如交酯(其包括乳酸以及d-、l-和meso交酯)、ε-己内酯、乙交酯(包括乙醇酸)、羟基丁酸酯、羟基戊酸酯、对二氧杂环己酮(dioxanone)、三亚甲基碳酸酯(及其烷基衍生物)、1,4-二氧杂环庚(dioxepan)-2-酮、1,5-二氧杂环庚-2-酮和6,6-二甲基-1,4-二氧杂环己-2-酮的聚合物和共聚物(聚乳酸和聚己内酯的共聚物是一个具体实例);聚醚聚合物和共聚物,包括聚芳醚如聚亚苯基醚、聚醚酮、聚醚醚酮;聚苯硫醚;聚异氰酸酯;聚烯烃聚合物和共聚物,包括聚烯烃如聚丙烯、聚乙烯(低和高密度、低和高分子量)、聚丁烯(如聚丁-1-烯和聚异丁烯)、聚烯烃弹性体(例如热塑性弹性体(santoprene))、乙烯丙烯双烯单体(EPDM)橡胶、聚-4-甲基-戊-1-烯、乙烯-α-烯烃共聚物、乙烯-甲基丙烯酸甲酯共聚物和乙烯-乙酸乙烯酯共聚物;氟化聚合物和共聚物,包括聚四氟乙烯(PTFE)、聚(四氟乙烯-共聚-六氟丙烯)(FEP)、改性乙烯-四氟乙烯共聚物(ETFE)和聚偏二氟乙烯(PVDF);有机硅聚合物和共聚物;聚氨酯;对亚二甲苯基聚合物;聚亚氨基碳酸酯;共聚(醚-酯)如聚环氧乙烷-聚乳酸共聚物;聚膦嗪;聚草酸亚烷基酯;聚草酰胺(polyoxaamide)和聚草酸酯(polyoxaester)(包括含氨和/或氨基的那些材料);聚原酸酯;生物聚合物如多肽、蛋白质、多糖和脂肪酸(及其酯),包括血纤蛋白、血纤蛋白原、胶原、弹性蛋白、壳聚糖、明胶、淀粉、糖胺聚糖如透明质酸;以及上述材料的共混物以及进一步的共聚物。
用于本发明中的粒子可以在组成、尺寸和形状方面广泛变化(例如球形、多面体、圆柱体、管、纤维、带状粒子、板状粒子以及其它规则和不规则的粒子形状)。
通常,在越过沉积的粒子的距离(例如球、圆柱体和管的直径,其它粒子包括板、带状粒子、纤维、多面体和其它规则和不规则粒子的宽度)小于100微米(μm)(长度通常要大得多),例如为100微米以上~50微米~25微米~10微米~5微米~2微米~1微米~500nm~250nm~100nm~50nm~25nm以下。在特定实施方案中,在越过沉积粒子上的距离小于1000nm、更典型地小于100nm的意义上,所述沉积粒子为亚微米粒子。
合适的粒子材料能够选自上述用作衬底材料的有机和无机材料。其中,不排除那些材料的粒子的其它实例可以选自聚合物微球,包括聚甲基丙烯酸甲酯(PMMA)微球和聚苯乙烯微球如得自于德国柏林Microparticles(http://www.microparticles.de/product_palette.html)的微球;氧化铝粒子,氧化钛粒子,氧化钨粒子,氧化钽粒子,氧化锆粒子,二氧化硅粒子;硅酸盐粒子如硅酸铝粒子,合成或天然的页硅酸盐,包括粘土和云母(任选地,可以将其进行插入和/或剥离)如蒙脱石、锂蒙脱石、水滑石、蛭石和合成锂皂石,和针状粘土如绿坡缕石,并且还包括微粒分子如多面体低聚倍半硅氧烷(POSS),所述多面体低聚倍半硅氧烷包括各种官能化POSS和聚合POSS的其它材料;多金属氧酸盐(例如Keggin型、Dawson型、Preyssler型等);富勒烯(例如“Buckey球”);碳纳米纤维;单壁碳纳米管和多壁碳纳米管(包括所谓的“少壁”纳米管)。
在某些实施方案中,在粒子内布置一种以上的治疗剂。
如上所述,在某些实施方案中,可以在本发明陶瓷涂层的全部或一部分上布置聚合物涂层(例如治疗剂洗脱的涂层、光滑涂层等)。如本文中所使用的,聚合物涂层为包含单一聚合物或不同聚合物的混合物的涂层,例如包含50wt%以下~75wt%~90wt%~95wt%~97.5wt%~99wt%以上的一种以上聚合物。所述聚合物可以是生物稳定的或生物可分解的。适用于该目的的聚合物可以选自例如上述用作衬底材料的一种以上聚合物。其中,不排除那些材料的聚合物的其它实例包括热塑性弹性体如聚(苯乙烯-共聚-异丁烯)嵌段共聚物、聚(甲基丙烯酸甲酯-共聚-丙烯酸丁酯)嵌段共聚物和热塑性聚氨酯;氟聚合物如PTFE、FEP、ETFE和PVDF;交联的水凝胶如交联的硫醇化硫酸软骨素;聚丙烯酸;聚乙烯基醇或聚乙烯基吡咯烷酮;聚酐,包括脂族聚酐如聚(癸二酸)或聚(己二酸)、不饱和聚酐如聚(4,4′-二苯乙烯二羧酸酐)、芳族聚酐如聚(对苯二酸);前述酐相互的共聚物,包括聚(脂族-芳族酐);和前述酐与其它单体的共聚物,包括聚(酯酐)和聚(醚酐);脂肪酸基酐;封端聚酐;支链聚酐;交联聚酐;和氨基酸基聚酐,参见N.Kumar et al.,“Polyanhydrides:an overview(聚酐:概述)”,Advanced Drug DeliveryReviews 54(2002)889-910,生物可降解的聚酯如聚交酯和聚(交酯-共聚-乙交酯);以及前述材料的共混物。
治疗剂洗脱的聚合物涂层的厚度可以广泛变化,典型地为25nm以下~50nm~100nm~250nm~500nm~1μm~2.5μm~5μm~10μm~25μm~50μm~100μm以上。如上所述,在某些实施方案中,聚合物涂层的厚度由存在于表面上的陶瓷壳的尺寸决定,然而在其它情况下不是。
在某些实施方案中,聚合物涂层为治疗剂洗脱的聚合物涂层。如本文中所使用的,“治疗剂洗脱的聚合物涂层”为包含治疗剂和聚合物的涂层,且从所述涂层洗脱掉至少一部分治疗剂,例如在与受治疗者接触时,或在植入或插入受治疗者时。所述治疗剂洗脱的聚合物涂层在涂层内典型地包含例如1wt%以下~2wt%~5wt%~10wt%~25wt%~50wt%以上的单种治疗剂或治疗剂的混合物。其中,治疗剂例如可以选自下面列出的那些材料。
可以使用任意合适的方法来施用聚合物涂层。例如在涂层含有具有热塑性特性的一种以上聚合物时,例如通过如下操作可以形成所述涂层:(a)提供含聚合物和所需要的任意其它任选物种如治疗剂的熔融物,和(b)随后将所述熔融物冷却。作为另一个实例,例如可以通过如下操作由可固化组合物(例如UV可固化组合物)形成所述涂层:(a)提供含有聚合物、固化剂和所需要的任意其它任选物种如治疗剂的可固化组合物;和(b)将所述组合物固化。作为还另一个实例,例如可以通过如下操作形成涂层:(a)提供含有一种以上溶剂物种、聚合物和所需要的任意其它任选物种如治疗剂的溶液或分散体;和(b)随后除去所述溶剂物种。例如通过辊涂(例如在期望向管式装置如支架的离腔表面涂布涂层时)或其它转印涂布技术,可以施用所述熔融物、溶液或分散体,其中涂布技术包括通过浸渍和通过喷涂,使用合适的施用装置如刷子、辊子、压模或喷墨印刷机进行施用。
根据本发明可以使用多种治疗剂,包括基因治疗剂、非基因治疗和细胞,可以将其用于治疗多种疾病和不适。
用于本发明中的合适治疗剂例如可以选自一种以上的下列材料:(a)抗血栓药如肝素、肝素衍生物、尿激酶、氯吡格雷和PPack(右旋苯丙氨酸脯氨酸精氨酸氯甲基酮);(b)抗炎症药如地塞米松、脱氢皮质醇、皮质酮、布地缩松、雌激素、柳氮磺胺吡啶和马沙拉嗪;(c)抗肿瘤试剂/抗增殖试剂/抗缩瞳试剂如紫杉醇、5-氟尿嘧啶、顺氯氨铂、长春碱、长春新碱、埃博霉素、内皮抑制素、血管生长抑素(angiostatin)、血管抑素(angiopeptin)、能够阻止平滑肌细胞增殖的单克隆抗体和胸苷激酶抑制剂;(d)麻醉剂如利多卡因、丁哌卡因和罗哌卡因;(e)抗凝血剂如D-Phe-Pro-Arg氯甲基酮、含RGD肽的化合物、肝素、蛭素、抗凝血酶化合物、血小板受体拮抗药、抗凝血酶抗体、抗血小板受体抗体、阿斯匹林、前列腺素抑制剂、血小板抑制剂和壁虱抗血小板肽;(f)血管细胞生长促进剂如生长因子、转录激活剂和翻译启动子(translational promotor);(g)血管细胞生长抑制剂如生长因子抑制剂、生长因子受体拮抗药、转录阻抑物、翻译阻抑物、复制抑制剂、抑制剂抗体、抗体导向抵抗生长因子、由生长因子和细胞毒素构成的双官能分子、由抗体抗体和细胞毒素构成的双官能分子;(h)蛋白激酶和络氨酸激酶抑制剂(例如酪氨酸磷酸化抑制剂(tyrphostins)、染料木黄酮、喹喔啉);(i)环前列腺素类似物;(j)胆固醇-减弱剂;(k)血管生成素(angiopoietins);(l)抗菌剂如三氯生、头孢菌素、抗菌剂肽如马加宁(magainins)、氨基糖苷类和硝化呋喃托英;(m)细胞中毒剂(cytotoxicagent)、细胞抑制剂和细胞增殖影响剂;(n)血管舒张剂;(o)干扰内源血管活性机理的药剂;(p)白血球补充的抑制剂如单克隆抗体;(q)细胞因子;(r)激素;(s)HSP 90蛋白的抑制剂(即热休克蛋白,其为分子伴护或保管蛋白且是使得其它客户蛋白/信号转导蛋白稳定和功能化所需要的,以用于细胞的生长和存活),包括格尔德霉素;(t)β-阻断药;(u)bARKct抑制剂;(v)受磷蛋白抑制剂;(w)Serca 2基因/蛋白;(x)免疫响应改性剂,包括氨基喹啉,例如咪唑喹啉如雷西莫特(resiquimod)和咪喹莫特;(y)人体载脂蛋白(例如AI、AII、AIII、AIV、AV等);(z)选择性雌激素受体调质(SERM)如雷洛昔芬、拉索昔芬、阿佐昔芬、米泼昔芬、奥培密芬(ospemifene)、PKS 3741、MF 101和SR 16234;(aa)PPAR激动药如罗西格列酮、匹格列酮、萘格列酮(netoglitazone)、非诺贝特、蓓萨罗丁(bexaotene)、胰岛素增敏剂(metaglidasen)、利格列酮(rivoglitazone)和替格列扎(tesaglitazar);(bb)前列腺素E激动药如前列地尔或ONO 8815Ly;(cc)凝血酶受体活化肽(TRAP);(dd)血管肽酶抑制剂,包括贝那普利、福森普利、赖诺普利、喹那普利、雷米普利、咪达普利、地拉普利、莫昔普利和螺普利;(ee)胸腺素β4。
其中,优选的非基因治疗剂包括紫杉烷如紫杉醇(包括其微粒形式,例如连接蛋白质的紫杉醇粒子如连接白蛋白的紫杉醇纳米粒子,例如ABRAXANE)、西罗莫司、依维莫司、他克莫司、zotarolimus、EpoD、地塞米松、雌二醇、卤夫酮、西洛他唑、格尔德霉素、ABT-578(AbbottLaboratories)、曲匹地尔、liprostin、Actinomcin D、Resten-NG、Ap-17、阿昔单抗、氯吡格雷、利多瑞尔、β-阻断药、bARKct抑制剂、受磷蛋白抑制剂、Serca 2基因/蛋白质、咪喹莫特、人体载脂蛋白(例如AI-AV)、生长因子(例如VEGF-2)以及前述材料的衍生物。
不必排除上述那些材料的大量治疗剂已经认定为血管和其它治疗方案的选择物,例如作为治疗再狭窄的试剂。这类试剂适用于本发明的实践,且合适的实例选自一种以上下列材料:(a)Ca-通道阻断药,包括苯并硫氮杂(benzothiazapines)如地尔硫卓和克仑硫卓,二氢吡啶如硝苯啶、阿罗地平和尼卡地平(nicardapine),和苯基烷基胺如戊脉安;(b)血清素路径调质,包括:5-HT拮抗药如凯耳讷和萘呋胺,以及5-HT摄取抑制剂如氟西汀;(c)环核苷酸路径试剂,包括磷酸二酯酶抑制剂如西洛他唑和双嘧哌胺醇,腺苷酸/鸟苷酸环化酶刺激物如福斯高林,以及腺苷类似物;(d)儿茶酚胺调质,包括α-拮抗药如哌唑嗪和布那唑嗪(bunazosine)、β-拮抗药如心得安和α/β-拮抗药如柳胺苄心定和卡文心安;(e)内皮素受体拮抗药如波生坦、司他生坦钠、阿曲生坦、艾多南坦(endonentan);(f)氧化一氮供体/释放分子,包括有机硝酸酯/亚硝酸酯如硝化甘油、二硝酸异山梨醇酯和亚硝酸戊酯,无机亚硝基化合物如硝普酸钠,斯得酮亚胺如吗导敏和林西多明,nonoates如二醇二氮烯鎓(diazenium diolates)和烷二胺的NO加合物,S-亚硝基化合物,其包括低分子量化合物(例如卡托普利、谷胱甘肽和N-乙酰基青霉胺的S-亚硝基衍生物)和高分子量化合物(例如蛋白质、肽、低聚糖、多糖、合成聚合物/低聚物和天然聚合物/低聚物的S-亚硝基衍生物),以及C-亚硝基化合物、O-亚硝基化合物、N-亚硝基化合物和L-精氨酸;(g)血管紧张素转化酶(ACE)抑制剂如西拉普利、福森普利和恩纳普利;(h)ATII-受体拮抗药如肌丙抗增压素和氯沙坦(losartin);(i)血小板粘附抑制剂如白蛋白和聚环氧乙烷;(j)血小板聚集抑制剂,包括西洛他唑、阿斯匹林和噻吩并吡啶(噻氯匹定、氯吡格雷)和GPIIb/IIIa抑制剂如阿昔单抗、依非巴特(epitifibatide)和替罗非班;(k)凝结路径调质,包括类肝素如肝素、低分子量肝素、葡聚糖硫酸酯和β-环糊精十四硫酸酯,凝血酶抑制剂如蛭素、二价水蛭素、PPACK(D-phe-L-丙基-L-arg-氯甲基酮)和阿戈托班,FXa抑制剂如反抑制素(antistatin)和TAP(壁虱抗凝血药肽),维他命K抑制剂如杀鼠灵,以及活化蛋白质C;(l)环氧化酶路径抑制剂如阿斯匹林、布洛芬、氟比洛芬、茚甲新和苯磺唑酮;(m)天然和合成的皮质甾类如地塞米松、脱氢皮质醇、甲基脱氢皮质醇和氢化可的松;(n)脂肪氧化酶路径抑制剂如去甲二氢化愈创木酸(nordihydroguaireticacid)和咖啡酸;(o)白细胞三烯受体拮抗药;(p)E-和P-选择蛋白的拮抗药;(q)VCAM-1和ICAM-1相互作用的抑制剂;(r)前列腺素及其类似物,包括前列腺素如PGE1和PGI2及环前列腺素类似物如西前列烯、依前列醇、carbacyclin、伊洛前列素和贝拉普罗;(s)巨噬细胞活化防护剂,包括双膦酸酯;(t)HMG-CoA还原酶抑制剂如洛弗斯塔特因、帕伐他丁、阿活他汀、氟伐地汀、辛伐他汀(simvastatin)和西立伐他汀;(u)鱼油和Ω-3-脂肪酸;(v)自由基清除剂/抗氧化剂如普罗布可、维他命C和E、依布硒啉、反式视黄酸、SOD(肝蛋白)、SOD仿造物、维替泊芬、罗培泊芬、AGI 1067和M 40419;(w)影响各种生长因子的试剂,包括FGF路径试剂如bFGF抗体和嵌合蛋白质,PDGF受体拮抗药如曲匹地尔,IGF路径试剂,其包括生长激素抑制素类似物如血管抑肽和奥曲肽(ocreotide),TGF-β路径试剂如聚阴离子试剂(肝素、岩藻多糖)、核心蛋白多糖和TGF-β抗体,EGF路径试剂如EGF抗体、受体拮抗药和嵌合蛋白质,TNF-α路径试剂如萨利多胺及其类似物,凝血噁烷A2(TXA2)路径调质如碘曲苯、伐哌前列素、咪唑乙氧基甲酸和利多瑞尔,以及蛋白质络氨酸激酶抑制剂如酪氨酸磷酸化抑制剂、染料木黄酮和喹喔啉衍生物;(x)基体金属蛋白(MMP)路径抑制剂如马马司他、伊洛马司他、metastat、戊聚糖多硫酸酯、瑞马司他(rebimastat)、incyclinide、apratastat、PG 116800、RO 1130830或ABT518;(y)细胞活动抑制剂如松胞菌素B;(z)抗增殖试剂/抗肿瘤试剂,包括抗代谢药如嘌呤类似物(例如6-巯基嘌呤或克拉屈滨,其为氯化嘌呤核苷类似物)、嘧啶类似物(例如阿糖胞苷和5-氟尿嘧啶)和甲氨蝶呤、氮芥、烷基磺酸酯、氮丙啶、抗生素(例如道诺红菌素、亚德里亚霉素)、亚硝基尿、顺氯氨铂、影响微管动力学的试剂(例如长春碱、长春新碱、秋水仙碱、EpoD、紫杉醇和埃博霉素(epothilone))、半胱天冬酶激活剂、蛋白酶体抑制剂、血管生成抑制剂(例如内皮抑制素、血管增殖抑制素和角鲨胺)、雷帕霉素(西罗莫司)及其类似物(例如依维莫司、他克莫司、zotarolimus等)、西立伐他汀、黄酮吡多(flavopiridol)和苏拉明;(aa)基体沉积/组织路径抑制剂如卤夫酮或其它喹唑酮衍生物、甲苯吡啶酮和曲尼司特;(bb)内皮愈合促进剂如VEGF和RGD肽;和(cc)血液流变调质如己酮可可碱。
此外,在Kunz等人的美国专利5733925号中还公开了适用于本发明实践的其它治疗剂。
现在参考附图对本发明的其它实施方案进行描述。
在图6A的示意性剖视图中显示的结构与图4A和4B中所述的那些类似,因为其包括衬底610,在其上已经布置了本发明的陶瓷涂层620,所述陶瓷涂层620包括由陶瓷层620c连接的凸起陶瓷壳620s,所述陶瓷层620c与衬底610共形。显示了布置在陶瓷区域620上方的聚合物涂层630,在该实施方案中,所述聚合物涂层630包含治疗剂。然而,与图4A和4B不同,图6A的中空陶瓷壳620s含有顺磁粒子640。顺磁粒子可以选自各种顺磁材料,其典型地为特定过渡元素、稀土元素和锕系元素的金属、合金或化合物(例如铁、包括磁铁矿的铁氧化物等)。
例如使用含有嵌入顺磁粒子的聚合物粒子(例如聚苯乙烯球)作为上述LBL/溶胶-凝胶法的模板,可以形成这种结构。在除去球的聚苯乙烯成分之后(例如通过热处理或溶解),顺磁粒子保留在陶瓷壳620s的内部。用陶瓷壳620s将顺磁粒子640与外部环境隔开。因为它们是顺磁的,所以能够使用外部磁场来振动它们陶瓷壳620s内部的这些粒子640。在其它效果中,这将产生热,所述热能够例如增加从聚合物涂层释放治疗剂的速率。作为替代实施方案,在聚合物粒子(例如可以提供聚苯乙烯粒子,其具有磁性涂层)外部上放置磁性材料(例如上述那些材料的一种)。更多的信息参见例如Marina Spasova et al.,“Magnetic andoptical tunable microspheres with a magnetite/gold nanoparticle shell(具有磁铁矿/金纳米粒子壳的磁性和光学可调的微球)”,”J.Mater.Chem.,15,(2005)2095-2098。如上所述,在这些实施方案中,将磁性材料嵌入最终形成的陶瓷壳中。
图6B为与图6A类似的结构,虽然没有聚合物涂层630。与图6A的结构类似,使用外部磁场能够对这种结构进行加热。例如能够使用所产生的高温引发人体内的坏死、血栓形成和其它生理效应。例如,可以在栓塞线圈上设置与图6B中所示类似的涂层,以治疗动脉瘤。在植入动脉瘤内之后,能够加热线圈,由此导致动脉瘤内的血栓形成。
如上所述,根据本发明能够形成比图4A、4B和6A复杂得多的结构,所述结构能够在陶瓷涂层和覆盖在其上的聚合物涂层之间产生更大程度的互锁。
在一个实施方案中,使用两种尺寸的带电粒子制造了这种结构。例如,参考图7A~7E,在第一步骤中,使用LBL法(例如通过浸入交替电荷的聚电解质溶液中)在衬底710上形成PML涂层712a。在图7A中所示的实施方案中,对聚电解质多层涂层712a的顶部聚电解质层进行正向充电。在随后的步骤中,将分别包含顶层带负电的PML涂层712b的球形粒子715b静电组装在如图7B中所示的PML涂层712a上。
接下来,将分别包含顶层带正电的PML涂层712c的球形粒子715c静电组装在如图7B中的结构上。将所得的结构示于图7C中。粒子715c大于粒子715b。而且,在所示实施方案中,一个以上的顺磁内核718位于各个粒子715c内。作为具体实例,可以使用聚苯乙烯球715b、715c。例如,可以从德国柏林的Microparticles采购200nm直径的较小球和500具有超顺磁内核的较大球。通过使内核718经历磁场,产生磁力(如图7C中的箭头所示),并且使涂布粒子715c与底层涂布粒子715b更紧密地联系,如图7D中所示。这提高了较大涂布粒子715c与几个较小涂布粒子715b接触的可能性,而不是仅悬在一个球上。比较图7C和7D。
然后,能够对图7D的结构进行进一步的聚电解质沉积步骤(例如通过浸入交替电荷的聚电解质溶液中),以根据需要增加各种PML涂层712a、712b、712c的厚度,并更好地将它们并入单一的连续PML结构中。结果为类似于图7E的结构。然后,在PML结构中,使用如上所述的溶胶-凝胶前体溶液,实施溶胶-凝胶型过程,由此形成聚电解质/陶瓷混合结构714,如图7F中所示。
然后,可以对图7F的结构进行进一步加工,以除去粒子715b和715c。例如,假设粒子715b和715c本身是聚合物(例如聚苯乙烯),则可以将图7F的结构加热至足以基本除去聚合物粒子715b和715c(并且也除去聚电解质/陶瓷混合结构714的聚合物成分)的温度,由此产生图7G中所示的陶瓷涂层720。作为连续结构的涂层720包括衬底覆盖部分720c和大量陶瓷壳720s。在大的陶瓷壳720内发现顺磁内核718,如果需要,现在能将其用于加热体内(或体外)的医疗器械。
应当注意,图7G的结构含有完全被陶瓷壳720s封装/包围的空间r1以及对外部环境敞开的空间r2。在如图7H中所示施用聚合物涂层730的情况下,空间r2为聚合物涂层730提供了形成与陶瓷涂层720完全互锁的界面的机会。
在另一个实施方案中,其中,能够利用细长粒子如碳纳米纤维或碳纳米管代替前面实施方案中所述的大球。关于前述大球,用PML涂层外涂细长粒子。例如,能够使用聚电解质官能化的碳纳米管或能够使用具有PML涂层的碳纳米管,如同在H.Kong et al.“Polyelectrolyte-functionalized multiwalled carbon nanotubes:preparation,characterization and layer-by-layer self-assembly(聚电解质-官能化的多壁碳纳米管:制备、表征和层叠自组装)”,Polymer 46(2005)2472-2485中所述。在类似于上述那些步骤以产生图7C的结构之后(除了使用细长粒子而不是大球,并且不利用磁力),以第一电荷的小球底层结束,所述小球由具有相反电荷的细长粒子连接。如上面图7E~7G中所述的进一步加工(聚电解质沉积、暴露于溶胶-凝胶前体、热处理)导致与图8A中所示的结构类似的结构。与图7G类似,图8A包括衬底810,在其上布置了本发明的连续陶瓷涂层820。区域820包括由陶瓷层820c连接的凸起陶瓷中空球形壳820s1,所述陶瓷层820c与衬底810共形。然而,与图7G不同的是,图8A的连续陶瓷涂层820还包括非中空、非球形的陶瓷壳820s2,所述陶瓷壳820s2含有细长粒子815。例如,所述细长粒子可以为碳纤维、碳纳米管或经受得住加工的任意其它细长粒子。从图8A中能够看出,这些陶瓷涂布的纤维815、820s2将中空陶瓷球820s1相互连接。或者,可以使用在热处理过程中被除去的细长粒子,与图8B中的结构类似的结构会导致这种情况,其中中空陶瓷纤维820s2将中空陶瓷球820s1相互连接。因为使用薄纤维与底层的陶瓷球(而不是更大的陶瓷球,如图7G中的情况)互连,所以类似于图8A和8B的结构比图7G中的结构应当更能承受弯曲或折曲。
如同图7G,图8A和8B的结构含有完全被陶瓷壳(即壳820s1、820s2)封装/包围的空间r1,以及对外部环境敞开的空间r2。这些空间r2为聚合物涂层830提供了与陶瓷涂层820形成完全互锁界面的机会,如图8C中所示。
在本发明的其它实施方案中,完全消除了球的使用。例如,可以向带电衬底(例如LBL涂布衬底)施用相反电荷的细长粒子(例如LBL封装的粒子)层,在许多其它的可能性中,所述粒子例如可以为耐热粒子如碳纳米管或不耐热粒子如聚苯乙烯纤维。在吸附粒子之后,可以进行LBL加工、溶胶-凝胶加工和热处理(参见上述),以制造含凸起陶瓷壳的陶瓷涂层,所述陶瓷壳可以含有细长粒子,或者其可以为全部或部分中空的。
在这个实施方案的变形中,可以向具有给定电荷(例如负电荷)的衬底(例如LBL涂布衬底)施用相反电荷(例如正电荷)的细长粒子(例如LBL涂布的粒子)层,继之以相反电荷(例如负电荷)的细长粒子(例如LBL涂布的粒子)的第二层等等。这些步骤可以继之以进一步LBL聚电解质加工、溶胶-凝胶加工和热处理。这种方法将因细长粒子而产生相对随机的取向,从而产生凸起陶瓷壳的复杂筛眼(所述壳再次可以被细长粒子填充或者部分或全部为中空的)。
通过使用AC电场将溶液内的细长粒子在沉积时进行定向,可以产生更规则的构造。例如,已知碳纳米管因响应电场而形成诱导偶极子而自身对准。DC电场将对准并移动纳米管,而AC电场仅将它们对准。在这点上,参见例如M.Senthil Kumar et al.,“Influence of electricfield type on the assembly of single walled carbon nanotubes(电场类型对单壁碳纳米管组装的影响)”,Chemical Physics Letters 383(2004)235-239。另外参见美国序号11/368,738。例如,利用电场对准,各个层的粒子可以在单一方向上全部对准。作为另一个实例,可以利用电场对准将相互正交的带正电和带负电的层对准。这些步骤可以再次继之以LBL聚电解质加工、溶胶-凝胶加工和热处理,从而形成基于碳纳米管的内部增强的牢固连接的陶瓷网络。
图9A~9D显示了本发明的其它实施方案。如图9A中所示,利用PML涂层对具有一个以上凹陷(例如盲孔910b)的衬底910进行涂布。在图9A中示意性显示了两个层,内部的正电聚电解质层912p和外部的负电聚电解质层912n,尽管可以施用单个层或三个以上的层。而且,外部层能够为正电层,而不是所示的负电层。所述衬底可以为例如在其内部形成(例如借助于激光烧蚀)大量盲孔的支架。
在随后的步骤中,选择性地向上衬底表面上的负电聚电解质层912n层的那些部分、但不是盲孔910b内的那些部分上,施用正电聚电解质层912p或以正电聚电解质层结束的多个交替的聚电解质层,从而得到类似于图9B的结构。这种结构在盲孔919b内具有负表面电荷并在盲孔外具有正表面电荷。(在图9A中的结构具有外部正电层的情况下,该步骤的电荷会反转,使得盲孔表面具有正表面电荷且结构的上表面具有负表面电荷。)在J.Park et al.,Adv.Mater.”,2004,16(6),520-525中描述了可以获得这种选择性施用技术的实例,其描述了在聚合物(聚二甲基硅氧烷)压模表面上吸附PML涂层的技术。吸附到压模上的第一层为阳离子聚烯丙胺盐酸盐(PAH)、继之以交替的阴离子磺化的聚苯乙烯(SPS)和阳离子聚二烯丙基二甲基铵氯化物(PDAC)。最后的层为阳离子PDAC。然后,将所述压模与具有负表面电荷的衬底接触,并将多层以其完整的形式从压模转印至衬底上。转印后的图案的顶层为阴离子PAH层。
在这点上,将图9B的结构暴露于具有负表面电荷的粒子。在图9C中所示的实施方案中,粒子为具有PML涂层的球915,以带负电的聚电解质层921p结束。如同本文中的其它地方,然后根据需要,能够任选地将图9C的结构设有附加聚电解质层,继之以溶胶-凝胶加工和热处理以制造类似于图9D的结构,所述结构包括具有陶瓷涂层的衬底910,所述陶瓷涂层包括由陶瓷层920c连接的凸起陶瓷壳920s(在图9D中,壳是中空的,尽管它们不必是中空的,如本文中其它地方所述),所述陶瓷层920c与衬底共形。在该实例中,仅在盲孔中发现了凸起陶瓷壳920s。
在本发明的另一方面中,完全消除了衬底的使用,所得的产物为涂有陶瓷层的碳纳米管的集合。例如,参考图10A,能够将碳纳米管1010设有聚电解质多层涂层1012。然后,将这种结构暴露于溶胶-凝胶前体中,从而形成如图10B中所示的聚电解质/陶瓷混合涂层1014,继之以热处理,以产生具有陶瓷涂层1020的碳纳米管1010,如图10C中所示。这类碳纳米管会应用于许多领域中,例如发现用作聚合物或金属中的补强粒子。碳纳米管通常处在因π-π键合而发生团聚的危险中,这由陶瓷涂层来阻止。
实施例1
现在对产生类似于图3B中所示涂层的步骤进行描述。
按如下制备溶液:(a)PAH溶液:利用下列成分在去离子水中制备了聚(烯丙胺盐酸盐)(PAH)(分子量:~70000)(西格玛奥德里奇公司(Sigma-Aldrich))的溶液:1g/L PAH、0.2M NaCl和0.05M NaAc(乙酸钠缓冲溶液,pH=5.6);(b)PSS溶液:利用下列成分在去离子水中制备了聚(4-苯乙烯磺酸钠)(PSS)(分子量~70000)(西格玛奥德里奇公司)的溶液:1g/L PSS、0.2M NaCl、0.05M NaAc(乙酸钠缓冲溶液,pH=5.6);(c)聚苯乙烯(PS)粒子溶液:接收聚(4-苯乙烯磺酸钠)粒子(500nm)(Forschungs-und Entwicklungslaboratorium,Berlin,Germany)的溶液以作为浓缩溶液(5wt%),并在去离子(DI)水中稀释至0.5wt%的浓度;(d)溶胶-凝胶溶液:将2g的TEOS(阿法埃莎庄信万丰有限公司(Alfa Aesar,Johnson Matthey Catalog Company,Inc.),Ward Hill,MA,USA)与100mL乙醇(Anhydrous,Denatured,产品序号为EX0285-3,电解二氧化锰化工公司(EMD Chemicals),Gibstown,NJ,USA)合并,并混合10分钟,其后添加10mL去离子水和1mL氢氧化铵(25%,在水中)(西格玛奥德里奇公司),继之以进一步混合。
使用下列工艺参数,在March AP-1000等离子体系统中,利用RF氧等离子体对不锈钢316L电解抛光的试样(3.5″×0.79″×0.03″)进行清洁:P=200毫托、300瓦特、气体1(氩气)=250sccm、气体2(氧气)=200sccm、t=180秒。
将所述试样设有1.5双层(PAH/PSS/PAH),继之以PS粒子层,继之以1.5双层(PAH/PSS/PAH)。所得的结构与图5A~5C(上述)中示意性显示的那些类似。关于各个聚电解质层,将试样浸入PAH或PSS溶液(按上述制备)的烧杯中,并在振动器上搅拌20分钟。关于PS粒子层,将试样浸入PS粒子溶液(按上述制备)的烧杯中,并在振动器上搅拌1小时。在各个层之后,进行三次去离子水漂洗,以除去未吸附的聚电解质/粒子,并将试样直接放入下一溶液中。
然后,将这种结构浸没溶胶-凝胶溶液(按上述制备)的烧杯中约16小时。在暴露于溶胶-凝胶溶液之后,进行三次去离子水漂洗。将所得的结构放入室温下的炉子中,并在~1.5小时内升温至最终温度540℃,所述结构类似于图5F(上述)中示意性显示的结构。在6小时的总周期时间(升温并在540℃下保持)之后,将炉子断电,并将试样在炉子中冷却过夜。最终的结构类似于图5F(上述)中示意性显示的结构。
实施例2
现在对产生类似于图11中所示的涂层的步骤进行描述。
按上面实施例1中所述,制备PAH溶液、PSS溶液和PS粒子溶液。关于溶胶-凝胶溶液,以将实施例1中的配方减半的方式来制备溶液。按如下制备绿坡缕石粒子溶液(Atta):在25mM的NaCl中提供50g/L的绿坡缕石粘土(50)(巴斯夫公司(BASF))。
使用下列工艺参数,在March AP-1000等离子体系统中,利用RF氧等离子体对16mm LibertéTM不锈钢支架进行清洁:P=200毫托、300瓦特、气体1(氩气)=250sccm、气体2(氧气)=200sccm、t=180秒。
将所述支架设有3.5双层(PAH/PSS/PAH/PSS/PAH/PSS/PAH),继之以2双层(Atta/PAH/Atta/PAH),继之以PS粒子层,继之以2双层(PAH/PSS/PAH/PSS)。关于各个聚电解质层和绿坡缕石粒子层,将支架浸入PAH、PSS或Atta溶液(按上述制备)的烧杯中,并在振动器上搅拌20分钟。关于PS粒子层,将支架浸入PS粒子溶液(按上述制备)的烧杯中并在振动器上搅拌1小时。在各个层之后,进行三次去离子水漂洗,以除去未吸附的聚电解质/粒子,并将支架直接放入下一溶液中。
然后,将这种结构浸没溶胶-凝胶溶液(按上述制备)的烧杯中约16小时,其后进行三次去离子水漂洗。将所得的结构放入室温(~23℃)下的炉子中,并在~1.5小时内升温至540℃。在炉子内6小时的总时间(升温并在540℃下保持)之后,将炉子断电,并将试样在炉子中冷却过夜。
实施例3
作为初始步骤,制备聚电解质涂布的碳纳米管。将聚(2-(N,N-二甲基氨基乙基)甲基丙烯酸酯(PDMAEMA)(0.15g)(西格玛奥德里奇公司,Bornem,Belgium)、NaCl(5.8g)和100mL的去离子水放入250mL的烧杯中,并进行搅拌直至PDMAEMA和NaCl完全溶解。通过添加2M的HCl将溶液的pH值调至3.7。然后,将利用羧基衍生的多壁碳纳米管(MWNT-COOH)(80mg)(低价管公司(Cheap Tubes,Inc.)112Mercury Drive,Brattleboro,VT,USA)添加至所制备的PDMAEMA溶液中。将混合物放入超声波浴(40kHz)中3分钟,然后温和搅拌30分钟。随后,通过0.22微米的微孔聚碳酸酯膜过滤器过滤分离固体,并用DI水洗涤三次。将所得的固体添加至100mL的PSS(1.5g/L)(SigmaAldrich,Bornem,比利时)和NaCl(1M)在DI水中的水溶液中,继之以与上述相同的步骤(超声波分散、温和搅拌、过滤和洗涤)。添加两个额外的PDMAEMA和PSS双层。在最终的洗涤步骤之后,以1g/L的浓度将所得的粒子悬浮在DI水中。利用该溶液代替上述实施例1中的PS溶液和上述实施例2中的Atta溶液。
尽管本文中具体显示和描述了各个实施方案,但是应当理解,本发明的修改和变化由上述教导涵盖,且在所附的权利要求书的范围内,而不背离本发明的主旨和期望范围。
Claims (30)
1.一种涂布制品,其包含衬底和覆盖衬底表面至少一部分的陶瓷涂层,所述陶瓷涂层包含由底部陶瓷层连接的凸起的第一陶瓷壳,所述底部陶瓷层与所述衬底表面共形。
2.如权利要求1所述的涂布制品,其中所述制品为医疗制品。
3.如权利要求2所述的涂布制品,其中所述医疗制品为可植入或可插入的医疗器械。
4.如权利要求3所述的涂布制品,其中所述医疗器械选自支架、电导线、电线圈、导管、注射针、导丝和栓塞装置。
5.如权利要求1所述的涂布制品,其中所述衬底选自金属衬底和聚合物衬底。
6.如权利要求1所述的涂布制品,其中所述陶瓷涂层含有选自硅、钛、锆、铱及其组合的氧化物中的一种以上氧化物。
7.如权利要求1所述的涂布制品,其中所述陶瓷涂层含有选自硅、钛、锆、铱及其组合的碳化物和氮化物中的一种以上物质。
8.如权利要求1所述的涂布制品,其中所述第一陶瓷壳和所述底部陶瓷层包含至少90wt%的金属氧化物。
9.如权利要求1所述的涂布制品,其中所述第一陶瓷壳至少是部分中空的。
10.如权利要求9所述的涂布制品,其中所述至少部分中空的第一陶瓷壳含有顺磁粒子。
11.如权利要求1所述的涂布制品,其中所述第一陶瓷壳包封选自聚合物材料、金属材料、陶瓷材料和碳中的材料。
12.如权利要求1所述的涂布制品,其中所述第一陶瓷壳呈球形。
13.如权利要求1所述的涂布制品,其中所述第一陶瓷壳是细长的。
14.如权利要求13所述的涂布制品,其中所述细长壳是对准的。
15.如权利要求1所述的涂布制品,其还包含连接至所述第一陶瓷壳的第二陶瓷壳。
16.如权利要求1 5所述的涂布制品,其还包含聚合物涂层。
17.如权利要求15所述的涂布制品,其中所述第一陶瓷壳和第二陶瓷壳呈球形。
18.如权利要求15所述的涂布制品,其中所述第一陶瓷壳和第二陶瓷壳是细长的。
19.如权利要求所述的涂布制品,其中所述第一陶瓷壳呈球形,所述第二陶瓷壳是细长的。
20.如权利要求1所述的涂布制品,其还包含聚合物涂层。
21.如权利要求20所述的涂布制品,其中所述聚合物涂层包含治疗剂。
22.如权利要求21所述的涂布制品,其中所述医疗器械为支架,其中所述治疗剂为抗增殖剂,其中所述陶瓷涂层布置在整个支架上,且其中所述聚合物涂层布置在支架的离腔表面上而不布置在支架的腔表面上。
23.如权利要求20所述的涂布制品,其中所述聚合物涂层选自光滑涂层、电绝缘涂层、生物可再吸收涂层和蛋白涂层。
24.如权利要求20所述的涂布制品,其中所述第一陶瓷壳呈球形,且其中所述聚合物涂层厚度由所述第一陶瓷壳的高度决定。
25.如权利要求1所述的涂布制品,其中所述衬底包含盲孔、通孔或两者,且其中所述陶瓷壳优先布置在所述孔中。
26.如权利要求1所述的涂布制品,其中所述陶瓷涂层包含:金属氧化物或半金属氧化物,以及聚电解质。
27.如权利要求26所述的涂布制品,其中所述陶瓷涂层还包含治疗剂。
28.如权利要求1所述的涂布制品,其中所述陶瓷壳包封含治疗剂的材料。
29.一种碳纳米管,其包含陶瓷涂层。
30.一种医疗制品,其包含具有陶瓷涂层的碳纳米管。
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WO2009018029A2 (en) | 2009-02-05 |
US7931683B2 (en) | 2011-04-26 |
CA2694686A1 (en) | 2009-02-05 |
EP2175902A2 (en) | 2010-04-21 |
JP2010534518A (ja) | 2010-11-11 |
US20090138077A1 (en) | 2009-05-28 |
WO2009018029A3 (en) | 2009-05-28 |
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