CN102056635B - 可生物蚀解的内置假体 - Google Patents
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
Abstract
一种内置假体，其可以包含一个含基底部分和覆盖于基底部分之上的表面部分的主体。所述基底部分可包含基体形式的生物蚀解性金属和在基体中的腐蚀促进沉积物。所述表面部分包含基体的生物蚀解性金属。当暴露于生理环境时表面部分具有第一蚀解速率，并且当暴露于生理环境时基底部分具有大于第一蚀解速率的第二蚀解速率。
Description
技术领域
本发明涉及一种可生物蚀解的内置假体(bioerodible endoprosthesis)，更特别地涉及一种可生物蚀解的支架。
背景技术
身体包括多种通道，例如动脉、其它血管，和其它身体内腔。有时这些通道会被堵塞或变弱。例如，通道可被肿瘤堵塞，被斑块狭窄，或由于动脉瘤而变弱。当这些情况发生时，通道可以使用医用内置假体再打开或增强，或甚至替换。内置假体通常为放置在体内的管腔中的管状构件。内置假体的实例包括支架、被覆假体、移植支架和血管闭合销。
内置假体可通过支承内置假体的导管递送到体内，当内置假体转移到所需位置时，其为压缩或缩小尺寸的形式。到达位置后，内置假体膨胀，例如，由此其可以接触到管腔壁。
膨胀机理可以包含迫使所述内置假体径向膨胀。例如，膨胀机理可以包含携带球囊的导管，其携带一个球囊扩张内置假体。球囊能够充气变形并且将膨胀的内置假体固定在与管腔壁接触的预定位置。然后球囊可以放气，导管缩回。
在另一种递送技术中，内置假体由可以可逆压缩和膨胀(例如弹性地或通过材料相变)的弹性材料形成。在导入体内期间，将内置假体控制在压缩状态。当到达所需植入位置时，去掉控制，例如，通过收回限制装置如(外鞘)，从而使内置假体通过其本身内部的弹性回复力能够自膨胀。
内置假体能够携带药物，例如抗增殖药物，以减少再狭窄(即，因治疗位置的体内免疫反应而产生的血管再闭合)的可能性。
发明概述
公开的内置假体包含一个含基底部分和覆盖于基底部分之上的表面部分的主体。基底部分包含基体形式的生物蚀解性金属和基体中的腐蚀促进沉积物。表面部分包含基体的生物蚀解性金属。当暴露于生理环境时，表面部分具有第一蚀解速率，并且当暴露于生理环境时基底部分具有大于第一蚀解速率的第二蚀解速率。
腐蚀促进沉积物包含惰性气体(例如，氦气、氩气、氖气、氪气或它们的组合)的纳米气泡。纳米气泡的平均直径可以为1nm至600nm之间。在一些实施方案中，腐蚀促进沉积物可包含银、锰或它们的组合。在其它实施方案中，腐蚀促进沉积物可包含与生物蚀解性金属相同的元素，并通过增强表面张力来提高蚀解速率。在一些实施方案中，腐蚀促进沉积物可比生物蚀解性金属更稀有或不如生物蚀解性金属稀有，并且当腐蚀促进沉积物暴露于生理环境中时，其与生物蚀解性金属形成电偶。在一些实施方案中，腐蚀促进沉积物更加稀有，并且作为阳极以加速生物蚀解性金属的蚀解速率。在其它实施方案中，腐蚀促进沉积物较不稀有，并且比生物蚀解性金属更快腐蚀，并且一旦腐蚀促进沉积物腐蚀掉，使基体材料的表面积增加，其加快生物蚀解性金属的蚀解速率。
表面部分可以基本不具有腐蚀促进沉积物。表面部分的厚度可为0.2微米至3微米之间。在一些实施方案中，表面部分可基本由生物蚀解性金属组成。表面部分可具有基本光滑的上表面。在此使用的术语“基本光滑”要求0.5μm或更小的Ra。
生物蚀解性金属可包含铁或其合金。在其它实施方案中，生物蚀解性金属可包含镁、锌、钨和它们的合金。
内置假体可以为支架。在其它实施方案中，内置假体为血管闭合销。
另一方面，公开了制备内置假体的方法。所述方法包括在包含生物蚀解性金属的主体中注入离子以生成基底部分和覆盖于基底部分之上包含生物蚀解性金属的表面部分，所述基底部分含有在生物蚀解性金属基体中的腐蚀促进沉积物。当暴露在生理环境中时，基底部分具有大于生物蚀解性金属主体表面部分的蚀解速率。
注入的离子可以为，在生物蚀解性金属基体内形成惰性气体纳米气泡的腐蚀促进沉积物的惰性离子和/或与生物蚀解性金属反应产生腐蚀促进沉积物的离子。在一些实施方案中，离子可以使用IBAD或PIII离子注入工艺注入。在一些实施方案中，离子可以小于1×1016个离子/cm2的剂量注入。离子可以至少10keV(例如，在10keV至100keV范围内)的最小能量注入。在一些实施方案中，离子注入工艺期间的温度范围为100℃至500℃之间。在一些实施方案中，温度为生物蚀解性金属熔化温度的0.2倍(例如，对于大多数镁基生物蚀解性合金为100-150℃，对于大多数铁基生物蚀解性合金为200-350℃)。
表面部分可以基本不含腐蚀促进沉积物。在一些实施方案中，在腐蚀促进沉积物注入后，内置假体可包含沉积在表面部分上的其它表面层。
生物蚀解性金属主体可以为支架或支架前体。在其它实施方案中，生物蚀解性金属主体可以为血管闭合销或血管闭合销前体。
下述的附图和描述给出了一个或多个实施方案的详述。其它特征、目的和优点将通过说明书和附图，以及权利要求书显而易见。
附图说明
图1为一个膨胀的支架的实施例的透视图。
图2A-2C描绘了根据不同实施方案的具有植入的离子皮下层的支架枝干的剖面图。
图3描绘了支架支杆的腐蚀曲线图。
图4表述了将离子注入到支架的示例性环境。
不同附图中相同的附图标记代表相同的部分。
发明详述
参照图1，支架20具有由多个支杆所限定的管状构件的形式。支杆可包含多个带22和多个延伸并连接在相邻的带之间的连接体24。使用时，带22可以从最初的小直径膨胀到较大直径以使支架20接触血管壁，从而保持血管开放。连接体24可以为支架20提供柔韧性和适应性，从而使支架适应血管的外形。
支架包含生物蚀解性金属。生物蚀解性金属的实例包括铁、镁、钨、锌以及它们的合金。例如，生物蚀解性金属可以为生物蚀解铁合金，其包含最高达20％的锰，最高达10％的银以及最高达5％的碳。生物蚀解性金属还可以是一种生物蚀解性镁合金，其包括最高达9％的铝、最高达5％的稀土金属、最高达5％的锌、最高达5％的锂、最高达5％的锰、最高达10％的银、最高达5％的铬、最高达5％的硅、最高达5％的锡、最高达6％的钇以及最高达10％的锌。合适的镁生物蚀解性合金包含ZK31，其包含3％的锌和1％的锆，ZK61，其包含6％的锌和1％的锆，AZ31，其包含3％的铝和1％的锌，AZ91，其包含9％的铝和1％的锌，WE43，其包含4％的钇和3％的稀土金属，和WE54，其包含5％的钇和4％的稀土金属。包含生物蚀解性金属的支架可以再打开和/或增强体内通道，还可以在超过时间后分解从而在治疗过程完毕之后使支架不再存在于身体通道之内。当暴露于生理环境中时，不同的生物蚀解性金属和支架支杆结构体可具有不同的蚀解速率。相应地，支架可以基于支架支杆的蚀解特性设计以在所需时间内保持所需结构性质。
如附图2A-2C所示，支架支杆(例如，带22和/或连接体24)包括一个表面部分32和一个基底部分34。在一些实施方案中，如附图2A所示，基底部分34可以沿着支架支杆的周边分布。在其它实施方案中，如附图2B和2C所示，基底部分34沿着支架支杆的所选侧，例如沿着支架的内径和/或外径分布。在一些实施方案中，如附图2C所示，支架支杆可具有沿着支架支杆外径分布的基底部分34和沿着内径分布的其它涂层38。
表面部分32覆盖在基底部分34上。表面部分32包含生物蚀解性金属，而基底部分34包含在生物蚀解性金属基体中的腐蚀促进沉积物28。当植入生理环境中时，表面部分32以第一速率得以蚀解。当表面部分蚀解至将基底部分暴露在生理环境中时，基底部分34以快于第一速率的第二速率得以蚀解。该蚀解曲线的实例描述于图3中。如所示的，支架的厚度随时间的消逝而减少。在最初的蚀解期42内，表面部分32以第一速率得以蚀解。在这个最初的蚀解期42内，生物蚀解支架提供了机械支撑功能。一旦表面部分32蚀解掉之后使基底部分34暴露于生理环境中，由于生物蚀解性金属基体中的腐蚀促进沉积物28的存在，可以产生加快的蚀解期44。通过具有慢于第二蚀解速率的第一蚀解速率的支架，支架支杆可以设计成比具有恒定蚀解速率的支架更小的原始尺寸，因为在最初蚀解期42中第一蚀解速率保护了最初治疗过程中支架的机械性能。然后加快的蚀解期44减少了削弱后的支架支杆在体内通道中存在的时间。
表面部分32的厚度可为0.1微米至3微米之间。表面部分32包括一个基本光滑的上表面。在此使用的术语“基本光滑”要求0.5μm或更小的Ra。表面部分32可以包含与包含于基底部分的生物蚀解性金属相同的生物蚀解性金属。表面部分32可以基本不含有任何腐蚀促进沉积物28。在一些实施方案中，表面部分32可以基本不含除了生物蚀解性金属之外的其它成分。在一些实施方案中，支架20可以包含在腐蚀促进沉积物沉积后沉积的其它表面层。例如，其它表面层可以通过由蒸汽沉积或脉冲激光沉积工艺，在表面部分32上沉积生物蚀解性金属形成。这些其它表面层的厚度为10微米或更大。
基底部分34包含腐蚀促进沉积物28。在一些实施方案中，基底部分的厚度可至少为1微米。在一些实施方案中，厚度为2微米至3微米之间。腐蚀促进沉积物28可以通过采用在基底部分注入离子而使表面部分基本不具有腐蚀促进沉积物28的能量注入离子而置于基底部分中。注入时离子的能级决定了注入的深度。例如，腐蚀促进沉积物28可以通过10keV的最小能量注入离子而产生。在一些实施方案中，离子可以在10keV至100keV之间的能量范围内注入。表面部分32和基底部分34的厚度可以通过注入离子所用的能量范围来确定。基底部分的厚度和深度也部分取决于生物蚀解性金属中包埋离子的扩散。包埋的离子可以产生垂直于表面的压力梯度，其迫使离子进一步进入支架支杆。该压力梯度能够迫使离子进一步进入生物降解材料。注入离子以形成腐蚀促进沉积物可以通过在每个腐蚀促进沉积物28周围产生高应力区域和/或压缩区域来提高基底部分34的蚀解速率。在一些实施方案中，可以使用离子束辅助沉积技术(“IBAD”)或等离子体浸没离子注入技术(“PIII”)注入离子。在一些实施方案中，离子注入工艺中的温度范围为100℃至500℃之间。在一些实施方案中，该温度约为生物蚀解性金属熔解温度的0.2倍(例如，对于大多数镁基生物蚀解性合金为100-150℃，对于大多数铁基生物蚀解性合金为200-350℃)。
图4举例说明了进行PIII的典型环境。为了进行PIII，将支架20的前体插入室体50中。支架20的前体包含一种生物蚀解性金属(例如，市售纯铁)。室体50是由含有等离子体56的真空54产生的真空室。等离子体56含有待注入支架20以形成腐蚀促进沉积物28的离子。支架20的前体使用脉冲发生器58产生的负电压重复脉冲。负电压脉冲导致电子从支架20中排斥出，而阳离子60被吸引到带负电荷的支架20上。因此，阳离子将撞击支架20的所有表面，并且被包埋入支架20和/或沉积到支架20上。
腐蚀促进沉积物28可以包含惰性气体的纳米气泡。惰性气体的纳米气泡可以通过增加生物蚀解性金属的表面积而提高生物蚀解性金属的蚀解速率。惰性气体的纳米气泡可以通过注入惰性气体离子而形成于生物蚀解性金属的基体之中。例如，腐蚀促进沉积物28可以包含氦气、氩气、氖气和/或氪气的纳米气泡。纳米气泡的平均直径可在1nm至600nm之间。当注入惰性气体离子以在基底部分34中产生惰性气体的纳米气泡时，可以控制剂量以防止纳米气泡迁移到表面部分32。在一些实施方案中，惰性气体离子的剂量保持在小于1×1016个离子/cm2。
腐蚀促进沉积物28可以包含加速腐蚀解过程的固体材料。例如，可以注入离子与生物蚀解性金属反应或形成合金以形成腐蚀促进沉积物28。例如，腐蚀促进沉积物可以包含银、铜和/或锰。在其它实施方案中，腐蚀促进沉积物可以包含与生物蚀解性金属相同的元素，并且通过增强表面张力来提高增加蚀解速率。在一些实施方案中，得到的腐蚀促进沉积物28可以通过在暴露于生理环境中时从剩余基体中分离，以而提高增加基底部分34的蚀解速率。在一些实施方案中，腐蚀促进沉积物或多或少的比可比生物蚀解性金属更稀有或更不稀有，并且当腐蚀促进沉积物暴露于生理环境中时，其与生物蚀解性金属形成电偶。在一些实施方案中，腐蚀促进沉积物更加稀有，并且作为阳极(anode)以加速提高生物蚀解性金属的蚀解速率。在其它实施方案中，腐蚀促进沉积物较不稀有，并且比生物蚀解性金属腐蚀解得更的快，从而当腐蚀促进沉积物腐蚀解掉之后，在基体材料上增加大表面积，以加速提高生物蚀解性金属的蚀解速率。例如，银和铜可以形成电偶，从而加速铁的腐蚀。
在一些实施方案中，腐蚀促进沉积物28可以不渗透进入支架支杆的中心部分36。如图3所示，当含有腐蚀促进沉积物28的基底部分蚀解后，剩余的支架支杆可在大量蚀解期(bulk erosion period)46中继续得以蚀解。由于因支架蚀解的变化而导致的支架支杆表面积增加，大量蚀解期46中的蚀解速率可以慢于加速蚀解期44中的蚀解速率，但是快于最初蚀解期42中的蚀解速率。
支架20可以是任意所需形状和尺寸(例如，股浅动脉支架、冠状动脉支架、大动脉支架、外周血管支架、胃肠支架、泌尿支架和神经支架)。根据应用，支架直径可以为例如1mm至46mm之间。在特定实施方案中，冠状动脉支架的膨胀后直径可以为2mm至6mm之间。在一些实施方案中，外周血管支架的膨胀后直径可以为5mm至24mm之间。在某些实施方案中，胃肠支架和/或泌尿支架的膨胀后直径可以为6mm至大约30mm之间。在一些实施方案中，神经支架的膨胀后直径可以为大约1毫米至大约12mm之间。腹主动脉瘤(AAA)支架和胸主动脉瘤(TAA)支架的直径可以为大约20mm至大约46mm之间。
支架20可包含一个或多个包含表面部分32和基底部分34的支杆。在一些实施方案中，支架可以为完全生物降蚀解的。在其它实施方案中，支架可以包括生物降蚀解性和非生物降蚀解性部分。在一些实施方案中，支架20可以包含选择处理各种带22和/或连接体24的选择性处理，以产生在预定区域和预定式样中以较快速率腐蚀解的支架，以从而控制支架的整体腐蚀解过程。。例如，连接体24的优先腐蚀解可以减少带22中的应力。优先腐蚀解区域可以通过如下方式产生：使不同区域具有不同含量和/或类型的腐蚀促进沉积物28，或者通过使不同区域具有不同表面部分厚度，和/或通使一些部分过缺少腐蚀促进沉积物28。
在某些实施方案中，支架20可适于释放一种或多种治疗剂。术语“治疗剂”包含一种或多种“治疗剂”或“药物”。术语“治疗剂”或“药物”互换使用，并且包括药物活性化合物，具有或不具有载体媒介(例如脂类)的核酸，致密剂(例如组蛋白)，病毒(例如腺病毒，腺伴随病毒，逆转录病毒，慢病毒和a-病毒)，聚合物，抗生素，透明质酸，基因治疗剂，蛋白质，细胞，干细胞等，或它们的组合，具有或不具有导向序列。由于需要保持细胞功能和活性配制介导的传递。常见的治疗剂实例包含紫杉醇(Paclitaxel)。
在一些实施方案中，支架20还包含覆盖于表面部分32之上的一个或多个涂层。在一些实施方案中，表面涂层可以进一步延缓表面部分32的蚀解。在一些实施方案中，涂层可以为包含治疗剂的药物释放涂层。
支架20使用导管传递系统而使用，例如传递和膨胀。在例如WangU.S.5,195,969，Hamlin U.S.5,270,086，和Raeder-Devens，U.S.6,726,712中描述了导管系统。支架和支架传递还以从波士顿科学公司(BostonScientific Scimed，槭树林(Maple Grove)，MN)得到的
系统为代表。
在一些实施方案中，支架还可以为被覆支架或移植支架中的一部分。在其它实施方案中，支架可以包含和/或连接到生物相容的，无孔或半孔的聚合物基体上，所述聚合物基体由聚四氟乙烯(PTFE)，膨胀PTEF，聚乙烯，氨基甲酸乙酯或聚丙烯制成。
在一些实施方案中，支架可以通过制备具有覆盖于基底部分之上的表面部分的丝(所述基底部分包含腐蚀促进沉积物)，并且编结和/或编织所述丝成管状构件得到。
在此涉及的所有出版物、参考文献、申请和专利全部引入本文作为参考。
其它实施方案包括在权利要求书中。
Claims (13)
1.一种内置假体，其包含由多个支杆所限定的管状构件，所述支杆包含：
（a）中心部分，它沿着所述支杆纵向延伸，该中心部分不含腐蚀促进沉积物；
（b）基底部分，其包含基体形式的生物蚀解性金属和基体中的腐蚀促进沉积物，该基底部分相对于所述中心部分径向向外延伸，该基底部分的厚度至少为1微米；和
（b）表面部分，其厚度为0.1-3微米，其覆盖在基底部分之上并相对于所述中心部分由所述基底部分径向向外延伸，该表面部分包含基体的生物蚀解性金属并基本不含腐蚀促进沉积物；
当暴露于生理环境时，所述表面部分具有第一蚀解速率，且当暴露于生理环境时，所述基底部分具有大于第一蚀解速率的第二蚀解速率。
2.如权利要求1所述的内置假体，其特征在于，所述腐蚀促进沉积物包含惰性气体的纳米气泡。
3.如权利要求2所述的内置假体，其特征在于，所述纳米气泡包含氦气、氩气、氖气、氪气或它们的组合。
4.如权利要求2所述的内置假体，其特征在于，所述纳米气泡的平均直径为1nm至600nm之间。
5.如权利要求1所述的内置假体，其特征在于，所述腐蚀促进沉积物包含银。
6.如权利要求1所述的内置假体，其特征在于，所述腐蚀促进沉积物包含锰。
7.如权利要求1所述的内置假体，其特征在于，所述腐蚀促进沉积物比所述生物蚀解性金属更稀有，当所述腐蚀促进沉积物暴露于生理环境中时，其与所述生物蚀解性金属形成电偶，并且所述腐蚀促进沉积物作为阳极。
8.如权利要求1所述的内置假体，其特征在于，所述腐蚀促进沉积物比所述生物蚀解性金属更不稀有，当所述腐蚀促进沉积物暴露于生理环境中时，其与所述生物蚀解性金属形成电偶，并且所述腐蚀促进沉积物作为阴极。
9.如权利要求1所述的内置假体，其特征在于，所述表面部分基本由生物蚀解性金属组成。
10.如权利要求1所述的内置假体，其特征在于，所述表面部分具有基本光滑的上表面。
11.如权利要求1所述的内置假体，其特征在于，生物蚀解性金属包含铁或其合金。
12.如权利要求1所述的内置假体，其特征在于，所述内置假体是支架。
13.如权利要求1所述的内置假体，其特征在于，所述基底部分的厚度为2-3微米。
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| PCT/US2009/046750 WO2009152153A2 (en) | 2008-06-10 | 2009-06-09 | Bioerodible endoprosthesis |
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- 2009-06-09 CN CN200980122076.9A patent/CN102056635B/zh not_active Expired - Fee Related
- 2009-06-09 WO PCT/US2009/046750 patent/WO2009152153A2/en active Application Filing
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Also Published As
| Publication number | Publication date |
|---|---|
| US20090306765A1 (en) | 2009-12-10 |
| WO2009152153A3 (en) | 2010-09-30 |
| EP2303348A2 (en) | 2011-04-06 |
| EP2303348B1 (en) | 2013-03-20 |
| JP5567010B2 (ja) | 2014-08-06 |
| WO2009152153A2 (en) | 2009-12-17 |
| JP2011522677A (ja) | 2011-08-04 |
| US8236046B2 (en) | 2012-08-07 |
| CA2727568A1 (en) | 2009-12-17 |
| CN102056635A (zh) | 2011-05-11 |
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