CN103249437B - 一种形成支架的方法 - Google Patents
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Abstract
一种形成支架的方法,包括把细长的组合构件或多个细长的组合构件成形为具有由冠互连的支杆的支架图案的步骤;所述组合构件包括外部构件和芯构件。形成通过所述组合构件的外部构件的开口。对所述组合构件进行处理,以便在不对外部构件造成负面影响的情况下从支架的至少多个支杆中除去芯构件且不从支架的至少多个冠区中除去芯构件,由此在至少多个支杆处留下具有内腔的外部构件且在至少多个冠区处留下具有芯构件的外部构件。然后,可用生物学或药理学活性物质填充这些内腔。
Description
技术领域
本发明涉及释放生物学或药理学活性物质的药物溶出性可植入式医疗器械、以及形成这种医疗器械的方法。
背景技术
近年来由于能够完成其主要功能(例如结构支撑)以及在植入区域起到医学治疗的作用,因此药物溶出性可植入式医疗器械已变得普遍。
例如,药物溶出性支架已用于防止冠状动脉中的再狭窄。药物溶出性支架可以递送生物学或药理学活性物质,例如抗炎化合物,该化合物阻断单核细胞的局部入侵/活化,因此防止了可引起血管平滑肌细胞(VSMC)增殖和迁移的生长因子的分泌。其他潜在抗再狭窄的化合物包括抗增殖剂,例如化疗药物(包括雷帕霉素和紫杉醇)。也已建议将其它类别的药物(例如抗血栓药、抗氧化剂、血小板聚集抑制剂和细胞抑制剂)用于抗再狭窄的用途。
可用聚合材料涂覆药物溶出性医疗器械,相应地用生物学或药理学活性物质或者生物学或药理学活性物质的组合浸渍该聚合材料。一旦在靶位置植入医疗器械,则从聚合物中释放出用于局部组织治疗的生物学或药理学活性物质。通过扩散经过用于生物稳定聚合物的聚合物层的过程、和/或当可生物降解聚合物的聚合物材料发生降解时,释放出生物学或药理学活性物质。
对生物学或药理学活性物质从浸渍聚合材料中的溶出速率的控制,通常是基于聚合物材料的性质。然而,在溶出过程结束时,在一些情况下剩余的聚合物材料与血管的不良反应有关,有可能形成小但却危险的血凝块。此外,在递送过程中医疗器械暴露表面上的药物浸渍聚合物涂层可能会剥落或者受损,因此阻止生物学或药理学活性物质到达靶部位。进而,药物浸渍聚合物涂层中要递送的生物学或药理学活性物质的量受到聚合物涂层可以携带药物的量和医疗器械尺寸的限制。利用聚合物涂层来控制溶出速率也是困难的。
因此,对能够利用医疗器械来递送增加量的生物学或药理学活性物质且能够改进对活性物质溶出速率的控制的药物溶出性医疗器械、以及形成这种医疗器械的改进方法存在着需求。
发明内容
在形成支架的方法的一个实施方式中,把包括外部构件和设置在外部构件内腔内的芯构件的细长组合构件成形为具有由冠区互连的多个支杆的支架图案。在把组合构件成形为支架图案之前或之后,在支杆处形成通过外部构件到达芯构件的开口。在把组合构件成形为支架图案之后,对组合构件进行处理以便在不对外部构件造成负面影响的情况下从支架的至少多个支杆中除去芯构件且不从支架的至少多个冠区中除去芯构件,由此在至少多个支杆中留下带内腔的外部构件且在至少多个冠区中留下带芯构件的外部构件。然后,可用生物学或药理学活性物质填充这些内腔。
在形成支架的方法的另一个实施方式中,把多个细长组合构件(各包括外部构件和设置在外部构件内腔内的芯构件)成形为具有由冠区互连的多个支杆的波形。使这些波形形成为多个圆柱形元件。这些圆柱形元件沿共同的纵向轴线对准并且连接到一起而形成管状支架。形成通过支杆的外部构件的开口。在使组合构件成形为波形之后,对这些波形进行处理使得在不对外部构件造成负面影响的情况下从波形的至少多个支杆中除去芯构件且不从波形的至少多个冠区中除去芯构件,由此在至少多个支杆中留下带内腔的外部构件且在至少多个冠区中留下带芯构件的外部构件。然后,可以用生物学或药理学活性物质填充所述内腔。
附图说明
基于如附图中所示的以下对本发明的描述,本发明的前述特征和优点及其它特征和优点将变得显而易见。并入本文中且构成本说明书一部分的附图,还可用来解释本发明的原理并且使相关领域的技术人员能够制作和使用本发明。附图不是按比例绘制的。
图1是示例性支架的一个实施方式的示意图。
图2是沿图1的直线A-A截取的截面图。
图3是沿图1的直线B-B截取的截面图。
图4是图1的支架的一部分的示意性纵向截面图。
图5是形成支架的方法的一个实施方式的流程图。
图6是芯线的示意性纵向截面图。
图7示出了形成为二维波形的芯线的一部分。
图8示出了波形,例如缠绕在心轴周围的图7的波形。
图9-12是说明图5的方法的各阶段的芯线的一部分芯线的的示意性侧面截面图。
图13是从支杆及其部分冠区中除去芯构件的支架的一部分的示意性侧面截面图。
图14是支架的一个实施方式的示意图。
图15是制造支架的方法的一个实施方式的流程图。
图16是多个芯线的示意性纵向截面图。
图17示出了形成为二维波形的多个芯线。
图18示出了缠绕成圆柱形元件的图17的波形。
图19-21是在图15的方法的各阶段的支架的示意图。
图22是支架的另一个实施方式的示意图。
图23是制造图22的支架的方法的一个实施方式的流程图。
图24和25是显示图23的方法中的步骤的、与开口邻接的支架的一部分的示意性纵向截面图。
图26-28是显示图23的方法的步骤的、显示支架的一个冠区的示意性纵向截面图。
具体实施方式
现在参照附图描述本发明的具体实施方式,其中相同的附图标记表示相同或者功能上相似的元件。
图1-4中示出了本文所揭示的支架100的实施方式。在图1所示的实施方式中,支架100由线101构成,线101弯曲或形成为一系列大体为正弦形的波,该正弦形波包括由弯曲的段或冠区108所连接的大体为平直的区段或支杆106并且螺旋状地缠绕成管,如图1所示。本文中使用的术语“线”表示细长元件或长丝或者 细长元件或长丝的组,并且不局限于特定的截面形状或材料。在图1所示的实施方式中,可利用例如熔接点124将纵向邻接的正弦曲线的所选择的冠区108加以连接。本文中的发明不局限于图1中所示的图案。支架100可以形成为适于用作支架的任何图案。例如但不限于:可以把支架100形成为授予Gianturco的美国专利第4,800,882号、授予Wiktor的美国专利第4,886,062号、授予Wiktor的美国专利第5,133,732号、授予Wiktor的美国专利第5,782,903号、授予Boyle的美国专利第6,136,023、和授予Pinchuk的美国专利第5,019,090中所公开的图案,上述各专利的全部内容以参考的方式并入本文中。
如图2-4中所示,已完成的支架100的线101在支杆区106(图2)是空心的并且在冠区108(图3)包括芯构件130。具体地,图2是沿图1的直线A-A截取的线101的截面图(在支杆106处)。图3是沿图1的直线B-B截取的线101的截面图(在冠区108处)。图4示出了在熔接点124处熔接到一起的相邻冠区108a、108b的示意性纵向截面图。如图4所示,芯构件130a、130b设置在外部构件102a、102b内且长度为冠区108a、108b的至少一部分,而外部构件102a、102b在支杆106a、106b处是空心的。如图2和图4所示,在支杆106处用生物学或药理学活性物质116(图4中的116a、116b)填充外部构件102的内腔110。
在支杆106处的通过外部构件102的开口120允许生物学或药理学活性物质116从内腔110中溶出。在所示的实施方式中,开口120的方向朝外或者指向支架的腔外表面。然而,开口120可设置在沿线101周长的任意位置。开口120在支杆106处沿支架100的长度被分散开并且允许生物学或药理学活性物质116通过外部构件102的壁从内腔110中释放出来。可根据需要来设计开口120的尺寸和形状,以便控制生物学或药理学活性物质116从支架100中的溶出速率。较大尺寸的开口通常能够实现较快的溶出速率,而较小尺寸的开口通常提供较慢的溶出速率。另外,开口120的尺寸和/或数量可沿支架100变化,从而改变生物学或药理学活性物质116在支架100的不同部分从支架100中溶出的量和/或速率。开口120可以具有例如但不限于,5-30μm的直径。开口120在深度上可具有恒定直径,或者具有锥形或圆锥形的形状。
图5-12示意性地示出制造具有图1-4的线101的图1的支架100的方法的一个实施方式。如图5中所示,步骤150采用如图6中所示的带外部构件和中央芯构件的线。这些类型的线有时称之为芯线,也可称之为组合构件。如图6示意性 所示,本文中的芯线140是由外部构件102以及内部或芯构件130构成。外部构件102成为支架100的空心线102,因此用相同的附图标记来标注。可用本领域已知的任何方法,例如但不限于拉制填充管线法、在内部构件上挤压外部构件、或者任何其它合适方法来形成芯线140。例如,适合于医疗应用的芯线是从印第安纳州Ft.Wayne的Ft.Wayne Metals公司获得的。
外部构件102可以是适于用作支架的任何材料。外部构件102,如下面更详细的说明,是将成为空心线102的经筛选材料。例如但不限于:外部构件102可以是不锈钢、“MP35N”、“MP20N”、镍钛合金(例如Nitinol)、镁、L605、或其组合。“MP35N”和“MP20N”是宾夕法尼亚州Jenkintown标准锻钢公司(Standard Press Steel Co.)的钴、镍、铬和钼的合金的商品名。“MP35N”通常由35%钴、35%镍、20%铬、和10%钼组成。“MP20N”通常由50%钴、20%镍、20%铬、和10%钼组成。对外部构件102的材料要求是生物相容,具有充分的弹性能用作支架,而且能够经受如下面更详细论述的除去芯构件130的处理。
芯构件130可以是如下所详述,当把芯线弯曲成支架图案时,为外部构件102提供充分支撑的材料。芯构件130可由与外部构件102的材料相比更不透射线的材料制成,以便实施者可以看见剩余的芯构件材料。此外,芯构件130是由牺牲材料制成的,可以通过不损害外部构件102的材料的步骤除去该牺牲材料。用于芯构件130的材料的例子包括但不限于:钽(Ta)、钨(W)、钼(Mo)、铌(Nb)、铼(Re)、碳(C)、锗(Ge)、硅(Si)及其合金。
如图6所示,外部构件102可具有在0.002英寸至0.010英寸范围内的外直径D1以及在大于或等于0.0005英寸范围内壁厚T。上面列出的值仅仅是示例性的,可根据例如使用的材料、期望的支架形状、靶位置、被溶出的生物学或药理学活性物质的量、以及本领域技术人员所了解的其它因素而采用其它直径和壁厚。
参照图5,步骤155是把芯线140成形为支架图案。如上所述,支架图案可以是图1中所示的图案、或者任何其它合适的由线所形成的图案。此外,尽管所有步骤中的顺序是不重要的,但应当在除去芯构件130(即,下面更详细说明的步骤165)之前执行步骤155。把芯线140成形为支架图案同时把芯构件130设置在外部构件102内有助于防止发生在外部构件102或内腔110中的扭折或其它变形。把芯线140成形为图1中所示的支架图案,通常包括把芯线140形成为二维波形的步骤,如图7中所示,接着把该波形缠绕在心轴122周围,如图8中所示。最 终结果是在心轴122上形成螺旋状支架图案。然后,可把螺旋状图案的所选择的冠区108熔合或激光熔合到一起并且可从心轴中除去支架。用于使芯线140形成为波形的方法可包括但不限于,2009年4月23日提交的美国专利申请第12/428,581号(其全部内容以参考的方式并入本文中)中所描述的方法,或者使芯线经过齿轮,例如授予Owens等人的美国专利第2,153,936号(其全部内容也以参考的方式并入本文中)中所揭示的那样。可采用本领域技术人员已知的其它方法把线形成为波形并把波形螺旋状地缠绕成管。
图5中所示的步骤160是提供通过外部构件102的开口120。可通过激光切割、钻孔、蚀刻或其他方法形成通过外部构件102的开口120。无需在步骤155之后或者在步骤165之前执行步骤160,尽管在某些情况下优选的是在步骤165之前,如下面更详细的说明。如果在步骤155之后执行步骤160,图9示出了带开口120的芯线140的一部分的示意性侧面截面图,开口120设置在支杆106处并通过外部构件102。在芯线140的整个长度上,把芯构件130设置在外部构件102内。
步骤165是在支杆106处蚀刻掉芯构件130。可以利用除去芯构件130同时保留外部构件102的任何合适方法来执行步骤165。具体地,如果外部构件102是由MP35N制成且芯构件130是由钽制成的,那么在低压(1-6托)和较高温度(大约110-150℃)下使芯线140接触二氟化氙(XeF2)气体导致二氟化氙(XeF2)气体与钽(Ta)芯构件130反应形成可以从内腔110排出的TaF5和Xe气体。类似地,二氟化氙(XeF2)气体与由钨、钼、铌、铼、碳、锗和硅制成的芯构件130发生反应。然而,二氟化氙(XeF2)气体不与由MP35N构成的外部构件102反应。合适的外部构件/芯构件组合以及除去芯构件的方法的其它例子参见2009年7月9日提交的共同待审的美国专利申请第12/500,359号,和共同待审的美国专利申请第[案卷号P36493]中,上述各专利申请的全部内容以参考的方式并入本文中。例如但不限于,诸如湿化学溶出、增溶、升华、和熔化的方法可用于合适的外部构件/芯构件组合。
图10-12示意性地示出了图5的步骤165。具体地,图10示出了芯线140接触蚀刻剂的部分,由箭头142表示。尽管图示的箭头142通常是在开口120处,但本领域技术人员认识到通常可把芯线140置于蚀刻剂包围芯线140的环境中。蚀刻剂不对外部构件102造成有害影响,但经过开口120开始蚀刻掉芯构件130,如图11中所示。因为开口120位于支杆区106,所以蚀刻剂蚀刻芯构件130开 始于开口120并且向冠区108继续腐蚀,如图11中所示。对使芯线140接触蚀刻剂的步骤的参数加以控制,以便从外部构件102中除去期望量的芯构件130。例如但不限于,可通过控制如下参数:接触蚀刻剂的时间、压力、开口120的尺寸和位置、以及影响芯线140除去的其它参数,从而从外部构件102中除去期望量的芯构件130。
在本实施方式中,在步骤165之后芯构件130的部分在冠区108保留。在一个实施方式中,通过封端或覆盖芯线140的端部而使蚀刻剂(诸如二氟化氙)通过开口120接触芯构件130。在一个非限制性例子中,把形成为支架图案的芯线140置于XACTIX有限公司的型号e1的二氟化氙蚀刻系统中。在一个非限制性例子中,把外直径为0.002至0.01英寸且壁厚为至少0.0005英寸的MP35N外部构件102以及直径为至少0.004英寸的钽芯构件130的芯线140置于型号e1的二氟化氙蚀刻系统机器中。用压强为8托的XeF2气体填充膨胀室。打开与处理室连通的阀,使得处理室中的压强小于8托。在此具体例子中,可在处理室温度为110℃下用每次30秒的30次循环除去所有的芯构件130。为了仅在支杆106处除去芯构件130,可减小循环的次数或持续时间。例如,5至29次范围内的循环将除去部分的芯构件130而不是整个芯构件130。
这些参数可根据芯构件130的尺寸、支杆106的长度、要除去的芯构件130的数量、开口120的尺寸、数量和位置、以及本领域技术人员已知的其它因素而变化。例如,可改变留在冠区108中的芯构件130的数量。可仅在小部分的冠区108中留下芯构件130(如图13中所示),或者在大部分冠区108中留下芯构件130(如图12中所示)。例如但不限于,可留下占据冠区108的内腔110的体积的5%至100%的芯构件130。由于其它因素仍然相同,因而相对于图12的实施方式,芯线140将会接触蚀刻剂达更多的循环或者更长的循环以便除去更多的芯构件130从而形成图13的实施方式。类似地,如果每个支杆106中存在2个或更多个开口120,而不是图9-12所示的一个开口120,那么可以通过调整循环的次数或者每次循环的时间来刻蚀期望量的芯构件130。
因此,在步骤165完成后,外部构件102保留并且已从支杆106中除去芯构件130,留下图12(或图13)中所示的结构。如上所述,假设存在使芯构件130接触蚀刻剂以便可在支杆处除去芯构件并且在冠区108处不除去芯构件130的方 法,则无需在除去芯构件130的步骤之前形成开口120。例如但不限于,可形成通过外部构件102的暂时入口,以便使芯构件130接触蚀刻剂。
在从支杆区除去芯构件130后,可把生物学或药理学活性物质116注入内腔110中,如图5的步骤170中所示。由此形成空心线或外部构件102,该构件102具有设置在支杆106处的内腔110中的生物学或药理学活性物质116、以及可从中溶出生物学或药理学活性物质116的开口120,如图2-4所示。可利用共同待审的美国专利申请第(案卷宗号P36494、P37957、P38015、P38005、P37967和P36172)(上述各专利申请的全部内容以参考的方式并入本文中)中所述方法、或者本领域技术人员所知的任何其它合适方法用生物学或药理学活性物质116填充内腔110。
由于某些原因,希望在至少一部分的冠区108留下芯构件130。例如但不限于,芯构件130使用不透射线的材料且在冠区108留下芯构件130可使得更容易地在治疗部位递送和放置期间看见支架。此外,在冠区108处留下芯构件130可提供用于使相邻绕组中的冠相互熔接的额外支撑,或者可在用生物学或药理学活性物质填充内腔110之后实现这种熔接。此外,在冠区108留下芯构件130,把内腔110划分成多个内腔。因此,可用第一生物学或药理学活性物质填充一些内腔,并用不同于第一生物学或药理学活性物质的第二生物学或药理学活性物质填充其它内腔。例如但不限于,一些内腔可具有指向支架的管腔侧的开口120并且用抗增殖剂填充,同时其它内腔可具有指向支架的内腔侧的开口120并且用抗血栓剂填充。在另一个非限制性例子中,不同的内腔可配置成在不同时间在体内释放相同的生物学或药理学活性物质,例如通过改变开口120的尺寸、使用添加剂或者可生物降解的衬里或栓、或者本领域技术人员已知的其它时间释放机制。可采用本领域技术人员已知的生物学或药理学活性物质的其它组合。
也可以在支架的部分冠区108留下芯构件130同时从支架的其它冠区108除去芯构件130。例如但不限于,支架的第一个绕组和最后一个绕组在冠区108处可包括芯构件130,同时剩余的中间绕组在冠区108处将不包括芯构件130。可通过在冠区108(其中在使支架接触蚀刻剂之前除去芯构件130)加入开口120而完成这种实施方式。因此,从带开口120的冠区108而不是无开口120的冠区108中除去芯构件130。由于某些原因,本领域技术人员可执行此步骤。例如但不限于,在支架的近端和远端的冠区处留下不透射线的材料而不是在所有冠区中留下不透 射线的材料,可以更好地看见支架的边界。在另一个例子中,理想的是在支架的中部具有较高剂量的生物学或药理学活性物质而在支架的端部具有较低剂量的生物学或药理学活性物质。由于本领域技术人员所已知的各种原因,具有或不具有芯构件的冠的其它变型会是理想的。
图14示意性地示出了支架200的一个实施方式,该支架200具有保留在部分冠区208且从支杆206和部分的冠区208除去的芯构件230。在图14所示的实施方式中,将芯构件230保持在螺旋状缠绕支架的相邻绕组之间的熔接位置224。在形成这种支架的方法的一个非限制性例子中,采用上述方法,除非在芯构件被除去的冠区处设置了开口220。此外,在支架的端部以及位置246、248处,可在支架200的部分支杆206处保留芯构件230。例如,在图14所示的实施方式中,希望保留有芯构件的一些冠区的近端是把芯构件保持在如位置246、248所示之间的支杆处。在例如图14所示的一个实施方式中,本领域技术人员可用不同的生物学或药理学活性物质加载支架的不同绕组。例如但不限于,部分的绕组可具有通到支架的内腔侧的开口220,同时把第一生物学或药理学活性物质设置在其内腔210中,而且其它绕组可具有通到支架的管腔侧的开口220,同时把第二生物学或药理学活性物质设置在其内腔210中。
图15是制造支架的方法的另一实施方式的流程图。如图15所示,步骤350是应用具有外部构件302和中央芯构件330的多根芯线340,如图16中所示。如上所述,芯线340可用于芯线140。为了进一步描述芯线340,包括对外部构件302和芯构件330的描述,上面对芯线140的描述并入本文中。图16示出了三个芯线340。本领域技术人员将会认识到,使用的线的数量可以变化且可取决于支架所需圆柱形元件(下述)的数量。
参照图15,步骤355是把各芯线340形成为具有由冠308互连的支杆306的二维波形304,例如如图17所示。步骤360是把各波形304形成为圆柱形元件312,如图18中所示。步骤365是沿共同的纵向轴线314对准圆柱形元件312并且例如利用熔合或者激光熔合把圆柱形元件312连接到一起。图19示出了沿纵向轴线314对准且在熔接点324相互熔接的圆柱形元件312。图19还示出了通过外部构件302所形成的开口320,如步骤370中所描述。所述开口可类似于上述开口120。此外,仅在支杆306中形成图19中的开口320。如上面参照图14所述,开口 320的位置可根据支架的哪个区域将包含生物学或药理学活性物质、哪个区域将具有被除去的芯构件330、以及本领域技术人员已知的其它因素而变化。
步骤375是在支杆306处蚀刻掉芯构件330。可以利用除去芯构件330同时保留外部构件302的任何合适方法(例如上述的以参考方式并入的方法)来执行步骤375。图20示出了接触蚀刻剂的支架300,由箭头342所表示。尽管图示的箭头342通常是在开口320处,但本领域技术人员认识到通常可把支架300置于蚀刻剂所包围的环境中。蚀刻剂不对外部构件302造成有害影响,但蚀刻剂通过开口320开始蚀刻掉芯构件330,如图20中所示。因为开口320位于支杆区306,所以蚀刻剂从开口320开始蚀刻芯构件330且朝向冠区308继续蚀刻,如图20中所示。如上所述,通过对使支架300接触蚀刻剂的步骤的参数加以控制,从而从外部构件302中除去期望量的芯构件330。在本实施方式中,在步骤375后,芯构件330在冠区308的部分保留。因此,在步骤375完成后,外部构件302保留且已从支杆306中除去芯构件330,从而留下图21所示的结构。如上所述,假设存在一种使芯构件330接触蚀刻剂以便可在支杆306处除去芯构件330且在冠308处不除去芯构件330的方法,则在除去芯构件330的步骤之前无需形成开口320。
在已从支杆区除去芯构件330之后,可把生物学或药理学活性物质注入内腔310,如图15的步骤380中所示。由此形成空心线或外部构件302,该构件302具有在支杆306处设置在内腔310中的生物学或药理学活性物质以及可通过其中溶出生物学或药理学活性物质的开口320。可利用上述且以参考方式并入本文的方法用生物学或药理学活性物质填充内腔310。
图22示意性地示出了支架400的一个实施方式的一部分。类似于上述实施方式,支架400包括线401,线401弯曲或形成为一系列大体为正弦形的波,该正弦形波包括大体为平直的区段或支杆406,该支杆406是由弯曲的区段或冠408所连接并且螺旋状地缠绕成管。应理解,也可以采用图15-21的实施方式,其中各圆形元件沿共同的纵向轴线而附接。
支架400的线401在支杆区406是空心的,因此线401在支杆区406包括内腔410。把芯构件430设置在线401的冠区408的内部,如图22和28所示。此外,芯构件430没有完全占据外部构件402的内腔410,即使是在冠区408也如此,因此内腔448利用冠区408把相邻支杆406的内腔410连接到一起。如图22和28 所示,用生物学或药理学活性物质416填充外部构件402在支杆406处的内腔410、以及设置在芯构件420与外部构件402之间的内腔448和冠区408。
在支杆406处通过外部构件402的开口420允许生物学或药理学活性物质416从内腔410/448中溶出。开口420可以与上述开口120相同或类似。
图23是说明制造支架400的方法的一个实施方式的图。步骤450是应用具有外部构件和中央芯构件的线。这种线可以是上述的芯线140。图24中示出了这种芯线440的一部分,包括外部构件402和芯构件430。图24还示出了在步骤460中所形成的通过外部构件402的开口420,(如上所述,可在步骤455之前或之后执行步骤460)。
参照图23,步骤455是把芯线440成形为支架图案。如上所述,支架图案可以是图1所示图案或者由线所形成的任何其它合适图案,或者可以是由多根线形成的一系列圆柱形元件,如图15-21所述。此外,尽管所有步骤的顺序并不重要,但应在除去芯构件430之前执行步骤455。把芯线440成形为图22中所示的支架图案,通常包括以上实施方式中所述的步骤。最终结果是形成于心轴上的螺旋状支架图案。然后,可把螺旋状图案的所选择的冠区408熔合或激光熔合到一起并且可从心轴中除去支架。
步骤465是在支杆406处蚀刻掉芯构件430。可以利用除去芯构件430同时保留外部构件402的任何适当方法(如上面参照步骤165的详细描述)执行步骤465。
在步骤465已完成后,支杆406包括具有内腔410的外部构件402,并且冠区408包括具有设置在内腔410中的芯构件430的外部构件402,如图26所示。步骤470是在冠区408处除去一部分的芯构件430,因此一部分的芯构件430在冠区408保留并且内腔448从支杆406处的内腔410经过冠区408延伸至在相邻的支杆406中的内腔410。内腔448是外部构件402的内腔410的一部分,但是不同地标注以便将其与在支杆406处的内腔加以区别。
可以通过本领域技术人员已知的任何方式完成步骤470。此外,可以作为步骤465的一部分或者在步骤465之后执行步骤470。在一个具体的非限制性例子中,氢氟酸和硝酸用作蚀刻剂442,用MP35N制成外部构件402并且用钽制成芯构件403。在该例子中,蚀刻剂442优先地从芯构件430与外部构件402的界面446蚀刻掉芯构件430,如图25中所示。当在从支杆406中除去芯构件之后执行这一 步骤时,蚀刻剂442开始在冠408处的芯构件430与外部构件402的界面除去芯构件430,如图28中所示。继续此步骤导致在保留于冠区域408的芯构件430的外壁与外部构件402的内壁之间形成内腔448,如图28中所示。本领域技术人员将会认识到,用于步骤470的蚀刻剂也可用于步骤465,因此同时执行这两个步骤。此外,本领域技术人员将会认识到,也可采用其它的蚀刻剂/芯构件/外部构件组合,只要它们能够实现通过芯构件或在芯构件周围的内腔而不除去整个芯构件。
在已从支杆区除去芯构件430且已提供通过冠区408的内腔448之后,可把生物学或药理学活性物质416注入内腔410/448,如图23的步骤475所示。由此形成空心线或外部构件402,该构件402具有分别设置在支杆406处的内腔410、448中以及冠区408中的生物学或药理学活性物质416,以及可经过其中溶出生物学或药理学活性物质416的开口420,如图22和28中所示。利用共同待审的美国专利申请第(案卷宗号P36494、P37957、P38015、P38005、P37967和P36172)(上述各专利申请的全部内容以参考的方式并入本文中)中所描述的方法、或者本领域技术人员已知的任何其它合适方法,用生物学或药理学活性物质416填充内腔410。
上述实施方式中对支架的进一步处理(例如退火、清洗、和本领域技术人员所了解的其它方法),可以在上述方法中的适当时间执行。例如但不限于,如果退火步骤会损害生物学或药理学活性物质,则可在用生物学或药理学活性物质填充支架之前对支架进行退火处理。类似地,可在用生物学或药理学活性物质填充支架之后执行最后的清洗步骤。此外,可通过将用于使蚀刻剂接触内腔以除去芯构件或者用于用生物学或药理学活性物质填充内腔的开口加以封闭,而控制生物学或药理学活性物质从支架中溶出的溶出速率和溶出时间。
术语“生物学或药理学活性物质”是指对身体或其部分具有药理学、化学或生物学效果的合成或天然的任何物质。可以用于本发明实施方式的合适的生物学或药理学活性材料包括但不限于:糖皮质激素类(例如地塞米松、倍他米松)、抗血栓药(例如肝素)、细胞生长抑制剂、水蛭素、血管抑肽、阿司匹林、生长因子(例如血管内皮生长因子(VEGF))、反义药物、抗癌药、抗增殖药、寡核苷酸类、抗生素;并且更概括地说,可使用抗血小板药、抗凝血剂、抗有丝分裂药物、抗氧化剂、抗代谢药、和抗炎药。抗血小板药可以包括如下药物:阿司匹林和双嘧达莫。阿司匹林被分类成镇痛、解热、抗炎和抗血小板药。在具有抗血小板特性 方面,双嘧达莫是类似于阿司匹林的药物。双嘧达莫也被分类成冠状血管扩张药。抗凝血药可包括如下药物:肝素、鱼精蛋白、水蛭素和抗凝血蛋白。抗癌药可包括如下药物:紫杉醇及其类似物或衍生物。紫杉醇也被分类成细胞生长抑制剂。抗氧化剂可包括普罗布考。抗增殖药可包括如下药物:氨氯地平、多沙唑嗪、西罗莫司(雷帕霉素)或者其它“limus”类化合物。抗有丝分裂药物和抗代谢药可包括如下药物:甲氨喋呤、硫唑嘌呤、长春新碱、长春花碱、5-氟尿嘧啶、阿霉素和丝裂霉素。抗生素可以包括青霉素、头孢西丁、苯唑青霉素、妥布霉素、庆大霉素。合适的抗氧化剂包括普罗布考。另外,可使用基因或核酸、或者其部分。可以首先把这种基因或核酸封装在脂质体或纳米粒中。此外,可使用胶原合成抑制剂(例如曲尼司特)。
本文中所述的支架通常可以用于身体的血管,用于在血管成形术后支撑该血管。已知从支架中溶出的某些生物学或药理学活性物质可防止再狭窄、或者与血管成形术或支架相关的其它并发症。或者,本文中所述的支架可使用于身体的其它器官或组织,用于药物的递送,以治疗肿瘤、炎症、神经系统疾病、或者本领域技术人员所了解的其它疾病。
虽然上面已对本发明的各种实施方式进行了描述,但应当理解的是这些实施方式仅以说明和示例为目的而并非以限制为目的而给出。对于相关领域的技术人员显而易见的是,在不背离本发明的精神和范围的情况下可以在形态和细节中做出各种变化。因此,本发明的广度和范围不应受任何上述示例性实施方式的限制,应当仅根据所附权利要求及其等效物来定义。也应当理解的是,本文中所论述各实施方式的各特征以及本文中引用的各参考文献可以结合任何其它实施方式的特征而使用。此外,并非意图受前面的技术领域、背景技术、发明内容或者具体实施方式中所给出任何明示或暗示的理论的约束。本文中所述的所有专利及公开的全部内容以参考的方式并入本文中。
Claims (22)
1.一种形成支架的方法,该方法包括以下步骤:
应用细长的组合构件,所述构件包括外部构件和设置在所述外部构件的内腔内的芯构件;
把所述组合构件成形为支架图案,所述支架图案包括具有由冠区互连的多个支杆的波形;
形成通过所述外部构件的开口;
在把所述组合构件成形为所述图案的步骤之后,对所述组合构件进行处理,以便在不对所述外部构件造成负面影响的情况下从所述波形的至少多个支杆中除去所述芯构件并且不从波形的至少多个所述冠区中除去所述芯构件,由此在至少多个所述支杆处留下具有内腔的外部构件并且在至少多个所述冠区留下具有所述芯构件的所述外部构件,
其中,对所述组合构件进行处理的步骤包括使所述组合构件接触蚀刻剂,所述蚀刻剂与所述芯构件反应除去所述芯构件,其中,所述蚀刻剂不与所述外部构件发生反应。
2. 如权利要求1所述的方法,该方法还包括在已除去所述芯构件之后用生物学或药理学活性物质填充所述内腔的步骤。
3.如权利要求2所述的方法,其特征在于,所述生物学或药理学活性物质选自抗肿瘤、抗有丝分裂、抗炎、抗血小板、抗凝血、抗纤维蛋白、抗增殖、抗生素、抗氧化剂、和抗过敏物质以及它们的组合。
4.如权利要求1所述的方法,其特征在于,所述蚀刻剂是溶解所述芯构件的液体化学品。
5.如权利要求1所述的方法,其特征在于,所述蚀刻剂是溶解所述芯构件的气体化学品。
6.如权利要求5所述的方法,其特征在于,所述外部构件由MP35N形成,所述芯构件由钽、钨、钼、铌、铼、碳、锗和硅中的一种形成,并且所述蚀刻剂是二氟化氙。
7.如权利要求1所述的方法,其特征在于,所述芯构件溶于所述蚀刻剂并且所述外部构件不溶于所述蚀刻剂。
8.如权利要求1所述的方法,其特征在于,从所有所述支杆中除去所述芯构件。
9.如权利要求1所述的方法,其特征在于,不从任何所述冠区中除去所述芯构件。
10.如权利要求1所述的方法,其特征在于,与所述外部构件相比所述芯构件更加不透射线。
11.如权利要求1所述的方法,该方法还包括以下步骤:在所述至少多个冠区中除去所述芯构件的一部分并且保留所述芯构件的另一部分,因此形成通过所述冠区的内腔同时所述芯构件的该另一部分保留在所述冠区中。
12.一种形成支架的方法,该方法包括下列步骤:
应用多个细长的组合构件,各组合构件包括外部构件和设置在所述外部构件的内腔中的芯构件;
将各组合构件成形为波形,所述波形具有利用冠区互连的多个支杆;
把各波形缠绕成圆柱形元件;
沿共同的纵向轴线对准所述圆柱形元件并且把所述圆柱形元件连接到一起以形成管状支架;
形成通过所述外部构件的开口;
在把所述组合构件形成为波形的步骤之后,对所述组合构件进行处理以便在不对所述外部构件造成负面影响的情况下从所述波形的至少多个支杆中除去所述芯构件并且不从所述波形的至少多个冠区中除去所述芯构件,由此在至少多个所述支杆中留下具有内腔的外部构件并且在至少多个冠区中留下具有芯构件的外部构件,
其中,所述对所述组合构件进行处理的步骤包括使所述组合构件接触蚀刻剂,所述蚀刻剂与所述芯构件反应除去所述芯构件,其中,所述蚀刻剂不与所述外部构件发生反应。
13.如权利要求12所述的方法,该方法还包括在已除去所述芯构件之后用生物学或药理学活性物质填充内腔的步骤。
14.如权利要求13所述方法,其特征在于,所述生物学或药理学活性物质选自抗肿瘤、抗有丝分裂、抗炎、抗血小板、抗凝血、抗纤维蛋白、抗增殖、抗生素、抗氧化剂、抗过敏物质及其组合。
15.如权利要求12所述的方法,其特征在于,所述蚀刻剂是溶解所述芯构件的液体化学品。
16.如权利要求12所述的方法,其特征在于,所述蚀刻剂是溶解所述芯构件的气体化学品。
17.如权利要求16所述的方法,其特征在于,所述外部构件由MP35N构成,并且所述芯构件由钽、钨、钼、铌、铼、碳、锗和硅中的一种构成,并且所述蚀刻剂是二氟化氙。
18.如权利要求12所述的方法,其特征在于,所述芯构件溶于所述蚀刻剂并且所述外部构件不溶于所述蚀刻剂。
19.如权利要求12所述的方法,其特征在于,从所有所述支杆中除去所述芯构件。
20.如权利要求12所述的方法,其特征在于,不从任何所述冠区中除去所述芯构件。
21.如权利要求12所述的方法,其特征在于,与所述外部构件相比所述芯构件更加不透射线。
22.如权利要求12所述的方法,该方法还包括以下步骤:在至少多个冠区中除去一部分的所述芯构件并且保留所述芯构件的另一部分,因此形成通过所述冠区的内腔同时所述芯构件的该一部分保留在所述冠区中。
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EP (1) | EP2616110B1 (zh) |
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US8333801B2 (en) | 2012-12-18 |
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EP2616110B1 (en) | 2016-07-20 |
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