CN101903051A - 用于生物医药用途的水凝胶细丝 - Google Patents

用于生物医药用途的水凝胶细丝 Download PDF

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CN101903051A
CN101903051A CN2008801220567A CN200880122056A CN101903051A CN 101903051 A CN101903051 A CN 101903051A CN 2008801220567 A CN2008801220567 A CN 2008801220567A CN 200880122056 A CN200880122056 A CN 200880122056A CN 101903051 A CN101903051 A CN 101903051A
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ethylenically unsaturated
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CN101903051B (zh
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格雷戈里·M·克鲁斯
迈克尔·J·康斯坦特
E·迈克尔·凯利
特兰·T·特伦斯
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Micro cents America Limited
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Abstract

本文描述了装置、组合物、系统和相关方法，它们使用具有延迟受控扩展速率的不透辐射水凝胶细丝在体腔内闭塞结构和畸形体，允许在所述结构或畸形体内对装置重定位。本发明还描述了用于在动物中植入的装置，其包含双功能的、低分子量烯属不饱和的可塑形的大单体；烯属不饱和单体；和不透辐射的元件，其中，所述装置不含支撑构件。本发明还公开了制成此类装置的方法。

Description

用于生物医药用途的水凝胶细丝
相关申请的交叉引用
本发明要求提交于2007年12月21日的美国临时专利申请号61/016,342的权益，该申请的全部公开内容通过引用并入本文。
发明领域
本发明一般性地涉及医药治疗装置和方法，更特别地，涉及在x射线荧光透视和核磁共振下可视的水凝胶细丝，以及在生物医药治疗中使用此类材料的方法。
发明背景
目前，对于患有脑和/或周边血管疾病的患者来说，介入性神经放射医师/神经外科医师有三种主要的拴塞(embolic)装置选择：铂弹簧圈(coil)、水凝胶/铂弹簧圈或可降解聚合物/铂弹簧圈。所有三种类型的弹簧圈被配置至动脉瘤中，它们具有与其相关的优点和缺点。铂弹簧圈易于通过标准微导管配置，并可获得宽广范围的柔软度，最适合用于具有小尺寸或颈的动脉瘤。水凝胶/铂弹簧圈也易于通过标准微导管配置。虽然水凝胶/铂弹簧圈较铂弹簧圈而言相对更僵硬，在动脉瘤内配置可能具有挑战性，但它们能在更广范围的囊和颈尺寸上提供可接受的结果。可降解的聚合物/铂弹簧圈易于牵引及配置进动脉瘤囊；但是，它们仅能在具有小尺寸或颈的动脉瘤中提供可接受的结果。
尽管有三种弹簧圈品种，但是人们对于易于配置进动脉瘤囊(例如铂弹簧圈)并且在宽广范围的动脉瘤尺寸中都可产生持久闭塞(例如水凝胶/铂弹簧圈)的拴塞装置仍有未满足的临床需求。本发明的装置和方法的益处之一是这样的装置：其通过比铂弹簧圈摩擦力更小的微导管牵引，像市售最软的铂弹簧圈那样配置于动脉瘤囊中，像水凝胶/铂弹簧圈那样扩展，并且提供动脉瘤囊的持久闭塞，同时允许介入性神经放射医师/神经外科医师或外科医师使用标准微导管或其它相关装备。
我们相信，水凝胶/铂弹簧圈的改善持久性是动脉瘤囊的增加的体积填充及弹簧圈物质稳定性的由此增加带来的结果。目前的水凝胶/铂弹簧圈版本具有末圈游丝(overcoil)，其限制了水凝胶的扩展。在临床前模型中，虽然目前的带末圈游丝的水凝胶/铂弹簧圈提供了比弹簧圈更好的结果，但是我们相信，无末圈游丝的水凝胶装置将比目前的带末圈游丝的版本僵硬度(stiffness)更低。本发明提供了下述拴塞装置，其能提供较之铂弹簧圈和带末圈游丝的水凝胶/铂弹簧圈二者都更增加的体积填充，以及较之带末圈游丝的水凝胶/铂弹簧圈更低的僵硬度。
在大和巨大的动脉瘤中，可能发生炎性并发症，推测这是由于大量的血栓形成和组织化导致的。我们相信，随着水凝胶提供的对动脉瘤囊的体积填充增加，血栓形成和组织化的发生将减少，并且推测导致的炎性并发症也更少。本发明提供了能降低炎性并发症的拴塞装置。
当弹簧圈在弹簧圈自身缠绕(winds)内发生互锁(interlocked)时，发生一种不常见的但潜在危险的并发症。在这种情况下，在保持动脉瘤位点内装置完整的同时既无法推也无法拉弹簧圈。唯一的选择是将弹簧圈从动脉瘤拉回并解开到腹股沟。潜在危险的结果是拉伸的弹簧圈。虽然已经开发了抗拉伸弹簧圈，但是该并发症并没有消除，其仍对患者加诸危险的威胁。我们相信，本发明的装置完全消除了该并发症。
发明内容
本文描述了装置、组合物、系统和相关方法，它们使用具有延迟受控扩展速率的水凝胶细丝在体腔内闭塞结构和畸形体，所述水凝胶细丝含有一种或多种可视试剂，允许所述装置在所述结构或畸形体内重定位。结构或畸形体可以是任何数量的脑和/或周边疾病的结果。通常，受控扩展速率是通过掺入具有可离子化官能团(例如胺、羧酸)的烯属不饱和单体来实现的。例如，如果丙烯酸掺入交联聚合物网络，那么将水凝胶在低pH溶液中孵育，以对羧酸质子化。在过量的低pH溶液被冲走、水凝胶干燥之后，可将水凝胶通过填充有生理pH的盐水或血液的微导管引入。在羧酸基团去质子化之前，水凝胶不能也不会扩展。相反，如果交联网络中掺入含胺的单体，那么在高pH溶液中孵育水凝胶以对胺去质子化。在过量的高pH溶液被冲走、水凝胶干燥之后，可将水凝胶通过填充有生理pH的盐水或血液的微导管引入。在胺基团质子化之前，水凝胶不能也不会扩展。
在一种实施方式中，本文描述了用于植入的装置，其包含双功能的、低分子量烯属不饱和的可塑形大单体；烯属不饱和单体；和可视试剂，其中，所述装置不含支撑构件(support member)。在一种实施方式中，支撑构件是金属性的。
在一种实施方式中，大单体具有大约100克/摩尔至大约5000克/摩尔的分子量。在另一实施方式中，水凝胶是环境应答性的。在又一实施方式中，烯属不饱和单体包含一种或多种可离子化的官能团。
在一种实施方式中，大单体包含聚乙二醇、丙二醇、聚(四亚甲基氧)、聚(乙二醇)二丙烯酰胺、聚(乙二醇)二丙烯酸酯、聚(乙二醇)二甲基丙烯酸酯、其衍生物或其组合。在另一实施方式中，烯属不饱和单体包含N，N’-亚甲基双丙烯酰胺、N-乙烯基吡咯烷酮、甲基丙烯酸-2-羟乙酯、其衍生物或其组合。
在一种实施方式中，可视试剂包括不透辐射元件，其包含具有单个不饱和点和至少一个碘原子的芳香族环、钽、钡、其盐，或其组合。在一种实施方式中，可视试剂是具有单个不饱和点和两个碘离子的芳香族环。在一种实施方式中，可视试剂包括钆或铁的氧化物，以在核磁共振成像下赋予可视性。
在一种实施方式中，烯属不饱和单体和可视试剂包含2，4，6-三碘苯基戊-4-烯酸酯、5-丙烯酰氨基-2，4，6-三碘-n，n’-双-(2，3二羟基丙基)异邻苯二甲酰胺、其衍生物或其组合。
在一种实施方式中，大单体和单体的聚合是N，N，N’，N’-四甲基乙二胺、过硫酸铵、偶氮二异丁腈、过氧化苯甲酰、2，2’-偶氮双(2-甲基丙脒)二盐酸盐、其衍生物或其组合引发的。
在一种实施方式中，可离子化的官能团包含酸性基团或碱性基团。在一种实施方式中，碱性基团包含胺基团、其衍生物或其组合。在另一实施方式中，酸性基团包含羧酸、其衍生物或其组合。
在一种实施方式中，水凝胶基本不含丙烯酰胺。在另一实施方式中，水凝胶基本上是生物不可再吸收的。在另一实施方式中，水凝胶是生物可再吸收的。
本文中一种实施方式中是制备用于植入动物的装置的方法：a)将双功能的、低分子量烯属不饱和的可塑形大单体，烯属不饱和单体，可视试剂和溶剂组合起来，制备前聚合物溶液；和b)处理前聚合物溶液，制备可在生理条件下扩展的水凝胶。
在所述方法的一种实施方式中，溶剂包括水、二氯甲烷、丙酮、异丙醇、乙醇或其组合。在另一实施方式中，双功能的、低分子量烯属不饱和的可塑形大单体具有大约100克/摩尔至大约5000克/摩尔的分子量。在又一实施方式中，烯属不饱和单体包含可离子化的官能团。
在所述方法的一种实施方式中，溶剂占前聚合物溶液的大约20％w/w至大约80％w/w。在另一实施方式中，单体占前聚合物溶液重量的大约40％至大约80％。
在一种实施方式中，所述方法还包含向前聚合物溶液中加入第二烯属不饱和单体的步骤。
在所述方法的一种实施方式中，可离子化的官能团包含碱性基团，处理步骤包含在高于所述碱性基团的pKa的pHs下对碱性基团进行去质子化，或者在低于所述碱性基团的pKa的pHs下对碱性基团进行质子化。在所述方法的另一实施方式中，可离子化的官能团包含酸性基团，处理步骤包含在低于所述酸性基团的pKa的pHs下对酸性基团进行质子化，或者在高于所述酸性基团的pKa的pHs下对酸性基团进行去质子化。
在另一实施方式中，描述了用于植入的装置，其中包含：双功能的、低分子量烯属不饱和的可塑形大单体，其分子量为大约100克/摩尔至大约5000克/摩尔；烯属不饱和单体；和可视试剂，其中，所述装置不含金属性支撑构件。
发明详述
本文描述了装置、组合物、系统和相关方法，它们用于闭塞一种或多种脑和/或周边血管疾病导致的结构和畸形体。使用具有延迟受控扩散速率的包含一种或多种可视试剂的水凝胶细丝来处理这些结构和畸形体，由此允许所述装置在结构或畸形体中重定位。此外，包含一种或多种可视试剂(例如，不透辐射的元件或填充剂)的具有受控扩展速率的水凝胶细丝向外科医师提供了足够的时间量来正确定位细丝，而无需为了细丝立刻扩展而匆匆忙忙。
通常，水凝胶细丝的受控扩展速率是通过掺入具有可离子化官能团(例如酸性或碱性基团)的烯属不饱和单体带来的。例如，如果丙烯酸掺入交联聚合物网络，那么将水凝胶在低pH溶液中孵育，以对酸性羧酸质子化。在过量的低pH溶液被冲走、水凝胶干燥之后，可将水凝胶通过填充有生理pH的盐水或血液的微导管引入。在羧酸基团去质子化之前，水凝胶不能也不会扩展。相反，如果交联网络中掺入碱性的含胺的单体，那么在高pH溶液中孵育水凝胶以对胺去质子化。在过量的高pH溶液被冲走、水凝胶干燥之后，可将水凝胶过填充有生理pH的盐水或血液的微导管引入。在胺基团质子化之前，水凝胶不能也不会扩展。
在一种实施方式中，不论在根据本发明的单体种类上利用酸性还是碱性基团，本文所述的装置在生理条件下都是可扩展的。本文中使用的生理条件表示具有在人体上或人体内发现的至少一种环境特征的条件。此类特征包括等压环境、pH缓冲环境、水性环境、大约7的pH或其组合，并可被发现于，例如，等压溶液、水、血液、脊髓液、血浆、血清、玻璃体液或尿中。
在一种实施方式中，本文中一般性描述了用于植入的装置，其包含双功能的、低分子量烯属不饱和的可塑形大单体，烯属不饱和单体和可视元件，其中所述装置不含支撑构件。在一种实施方式中，装置含有一种或多种支撑构件，但是这些支撑构件是非金属性的。非金属性的支撑构件可以是聚合物性的。在一种实施方式中，所述装置具有一种或多种不透辐射的或可视的支撑构件。在一些实施方式中，在本文描述的装置中不需要支撑构件来控制水凝胶的扩展，因此，它们并不被掺入本文所述的装置和系统中。
此外，在本文所述的装置中不存在金属性支撑构件允许在多种成像过程中分辨率更好。金属性支撑构件在成像时，例如，可通过从金属性支撑构件产生闪光或反射来扭曲装置的成像。因此，如本文所教导的，提供不具有金属性支撑构件但是包含一种或多种可视试剂(例如不透辐射的元件或填料)的装置允许本领域技术人员在植入期间和之后都获得更精确和精准的装置成像。此类没有金属性支撑构件的装置可包含成像技术不可视的支撑构件，例如，聚合物性的支撑构件。
在另一实施方式中，本文描述了制备用于在动物中植入的装置的方法，所述方法包括下述步骤：将双功能的、低分子量烯属不饱和的可塑形大单体，烯属不饱和单体，可视试剂和溶剂组合起来，制备前聚合物溶液；以及，处理前聚合物溶液，制备可在生理条件下扩展的水凝胶。
通常，前聚合物溶液包含溶剂，双功能的、低分子量烯属不饱和的可塑形大单体，具有一种或多种可视试剂的烯属不饱和单体，可离子化的烯属不饱和单体，一种或多种任选的具有可视试剂(具有或不具有辐射不透性)的烯属不饱和单体，以及任选的成孔剂(porosigen)。或者，前聚合物溶液包含溶剂，双功能的、低分子量烯属不饱和的可塑形大单体，任选的一种或多种烯属不饱和单体，任选的交联剂和一种或多种可视试剂，例如不透辐射的元件或填料，其包括但不限于钡、钽、铂和金。
前聚合物溶液中的溶剂作用于完全溶解前聚合物溶液中的所有大单体和单体。如果使用液体单体(例如甲基丙烯酸2-羟乙酯)，那么可能不需要溶剂。如果需要的话，基于大单体和单体的溶解度来选择溶剂。优选的溶剂是异丙醇(IPA，异丙醇)、乙醇、水、二氯甲烷和丙酮；但是可利用多种其它溶剂，它们也是本领域技术人员已知的。优选的溶剂浓度在前聚合物的大约20％w/w至大约80％w/w的范围内，更优选在大约40％w/w至大约60％w/w的范围内。在一种优选的实施方式中，溶剂浓度为前聚合物溶液的大约33％w/w。
双功能的、低分子量烯属不饱和的可塑形大单体在聚合期间作用于交联聚合物链以及向得到的聚合物赋予柔性。此类大单体包含至少一个烯属不饱和点和两个官能位点。在一种实施方式中，至少一个烯属不饱和基团可以是官能位点之一，或者可以是两个官能位点。在一种实施方式中，本文所述的大单体具有低分子量。本文所述的大单体具有范围为大约100g/摩尔至大约5,000g/摩尔范围内的分子量，或大约200g/摩尔至大约2,500g/摩尔，更优选地大约400g/摩尔至大约1,000g/摩尔的分子量。优选的大单体是聚(乙二醇)二丙烯酰胺，因为其生物相容性并且在多种溶剂中可溶。如果需要得到的聚合物降解，优选的大单体是聚(乙二醇)二丙烯酸酯。或者，更疏水的大单体，例如，聚醚、聚(丙二醇)和聚(四亚甲基氧)或聚烯烃(例如聚(乙烯))的衍生物是合适的。其它合适的大单体包括聚乙二醇、丙二醇和聚(乙二醇)二甲基丙烯酸酯。
“烯属不饱和的”在本文中使用时通常描述具有下述基团的化合物，所述基团例如但不限于：乙烯基、丙烯酸酯基、甲基丙烯酸酯基或丙烯酰胺基，包括其衍生物或其组合。
“可塑形”大单体在本文中用于描述大单体的相对刚性(rigidity)以及其保持特定形状的能力。例如，根据本发明的可塑形大单体可使用心轴等装置形成，并可保持得到的用于植入的形状。
具有一种或多种可视试剂的烯属不饱和单体作用于使得到的聚合物在合适的可视方法下具有可视性。在一种实施方式中，烯属不饱和单体包含不透辐射的元件或者不透辐射的元件单独作用于向得到的聚合物赋予不透辐射性。具有单不饱和基团和一个或多个碘原子的芳香族环是优选的具有不透辐射元件的烯属不饱和单体。例子包括：2，4，6-三碘苯基戊-4-烯酸酯和5-丙烯酰氨基-2，4，6-三碘-n，n’-双-(2，3二羟基丙基)异邻苯二甲酰胺。具有不透辐射元件的不饱和单体的优选浓度范围为前聚合物溶液的大约40％w/w至大约80％w/w，更优选地，为前聚合物溶液的大约40％w/w至大约60％w/w。或者，可将不透辐射元件或填料例如，钽、钡或其盐，掺入前聚合物溶液，为了代替不透辐射元件或在它们之外掺入。不透辐射的填料负载范围为所得聚合物的大约40％w/w至大约60％w/w。
本文中使用的“可视试剂”指加入本文所述的装置或包括在本文所述的装置内、赋予在植入期间或之后使装置可视的手段的任何元件。可视的方法包括但不限于x射线、超声波、荧光透视、红外辐射、紫外光方法、核磁共振及其组合。在一种实施方式中，可视试剂可以是一种或多种不透辐射的元件或填料(radiopaque element or filler)，其向本文所述的装置赋予不透辐射性。在另一实施方式中，可视试剂可以是非不透辐射的元件或填料(non-radiopaque element or filler)，例如钆或铁的氧化物。此类非不透辐射的元件或填料不向本文所述的装置赋予不透辐射性，其可通过例如核磁共振成像。
“不透辐射”在本文中使用时表示这样的元件或填料，其向本文所述的装置赋予不透辐射性，并可通过电磁辐射的手段检测到，所述手段例如但不限于x-射线、超声波、荧光透视、红外、紫外及其组合。在一种实施方式中，本文所述的不透辐射元件可使用x-射线或x-射线荧光透视检测到。
可离子化的烯属不饱和单体作用于延迟水凝胶细丝的扩展，由此建立受控扩展速率。在一种实施方式中，选用的单体的至少一部分，优选地，单体溶液的大约5％至大约50％w/w，更优选地，前聚合物溶液的大约5％至大约25％w/w，是可离子化的。优选的可离子化的单体可以是丙烯酸或甲基丙烯酸。两种酸的衍生物和盐也是合适的可离子化组分。或者，在一种实施方式中，不利用可离子化的烯属不饱和单体。
在一种实施方式中，使用任选的具有向或不向装置赋予不透辐射性的可视试剂的烯属不饱和单体来协助聚合过程，其可以是任何单官能或多官能的烯属不饱和化合物。在一种实施方式中，低分子量的、具有非不透辐射性的可视试剂的烯属不饱和单体是优选的。甲基丙烯酸羟乙酯(例如，甲基丙烯酸2-羟乙酯)、丙烯酸羟乙酯、N-乙烯基吡咯烷酮和N，N’-亚甲基双丙烯酰胺是优选的具有非不透辐射性的可视试剂的烯不饱和单体。具有非不透辐射性的可视试剂的烯属不饱和单体的优选浓度小于前聚合物溶液的大约5％w/w，更优选地，小于大约1％w/w。
在一种实施方式中，除了不透辐射元件之外，本文所述的水凝胶和装置还包含可视试剂，例如，钆或铁的氧化物，以赋予装置在核磁共振成像下的可视性。在其它一些实施方式中，使用钆或铁的氧化物代替不透辐射元件。
任选的成孔剂在得到的聚合物中赋予孔。水凝胶材料的多孔性是前聚合物溶液中成孔剂的过饱和悬浮液赋予的。还可使用不溶于前聚合物溶液但是溶于洗涤溶液的成孔剂。在一种实施方式中，氯化钠是优选的成孔剂。在其它一些实施方式中，冰、蔗糖和碳酸氢钠液可用作为成孔剂。优选地，成孔剂的颗粒尺寸小于大约25微米，更优选小于大约10微米。小的颗粒尺寸有助于成孔剂在溶剂中悬浮。优选的成孔剂浓度小于前聚合物溶液的大约50％w/w，更优选小于大约20％w/w。在根据本发明的一些实施方式中，不使用成孔剂。
可通过氧化还原、辐射、热和本领域已知的任何其它方法来交联前聚合物溶液。可使用合适的引发剂用紫外光或可见光或者使用电离辐射(例如电子束或γ射线)但不用引发剂来实现对前聚合物溶液的辐射交联。可通过使用热源(例如加热井)来传统地加热溶液，或通过对前聚合物溶液应用红外光的方式应用热来实现交联。
在一种优选的实施方式中，交联方法利用偶氮二异丁腈(AIBN)或另外的水溶性的AIBN衍生物(2，2’-偶氮双(2-甲基丙脒)二盐酸盐)。可用于本发明的其它交联剂包括N，N，N’，N’-四甲基乙二胺、过硫酸铵、过氧化苯甲酰及其组合，包括偶氮二异丁腈。在一种实施方式中，在升高的温度下使用AIBN或其衍生物。在加入AIBN之后，使用内直径范围为0.012英寸至0.075英寸的聚(乙烯)管注射前聚合物溶液，并在80℃孵育若干小时。选择聚(乙烯)管向微导管或导管赋予相容性。为经由微导管进行递送，直径为大约0.012英寸至大约0.025英寸的聚(乙烯)管是优选的。为经由5 French Size(Fr)导管进行递送，直径为大约0.030英寸至大约0.050英寸的聚(乙烯)管是优选的。或者，可利用同样直径的HYTREL
Figure BPA00001161636800091
(DuPont，Wilmington，DE)管。HYTREL
Figure BPA00001161636800092
管可溶于溶剂中，协助从管中除去聚合物。
如果在前聚合物溶液聚合之前用管缠绕心轴，那么得到的聚合物将保持聚(乙烯)或HYTREL
Figure BPA00001161636800101
管的形状，这主要是前聚合物溶液中的可塑形大单体导致的。使用这种技术，可向聚合物赋予螺旋形、飓风形或复杂的形状。赋予的形状的记忆受到大单体选择的强烈影响。更疏水的大单体较之更亲水的大单体而言能更好地保持其被赋予的形状。优选地，该实施方式中使用烯属不饱和可塑形大单体。
在一种实施方式中，本文描述的装置是环境应答性的。本文中使用的环境应答性表示装置以某种方式应答于周围环境而变化。在一种实施方式中，对周围环境的这种应答以受控扩展速率的形式存在。本文所述的水凝胶的受控扩展速率是通过对水凝胶网络之中或之上存在的可离子化的官能团的质子化/去质子化来实现的。一旦制备了水凝胶并且洗去了未掺入的大单体、单体和寡聚体，就可进行控制扩展速率的步骤。
如果将具有羧酸基团的单体掺入水凝胶网络，那么在低pH溶液中孵育水凝胶。溶液中的游离质子对水凝胶网络中的羧酸基团进行质子化。孵育的长度、孵育期间的温度以及溶液的pH影响对扩展速率的控制的量。通常，孵育的长度和温度与扩展控制的量呈正比，而溶液pH则呈反比。令人惊奇的是，我们发现，处理溶液的水含量也会影响到扩展控制。随着水含量的增加，水凝胶能在处理溶液中更为扩展，推测质子化可利用增加量的羧酸基团。为最大化对扩展速率的控制，可能需要优化水含量和pH。孵育结束后，洗去过量的处理溶液，干燥水凝胶材料。已经观察到，经低pH溶液处理过的水凝胶要比未经处理的水凝胶干燥至更小的体积。在一种实施方式中，因为想要经由微导管递送这些水凝胶材料，所以使用更小体积的水凝胶。
相反，如果在水凝胶网络之中或之上掺入具有胺基的pH敏感性单体，那么在高pH溶液中孵育水凝胶。高pH下，质子化在水凝胶网络的胺基上发生。孵育的长度、孵育期间的温度以及溶液的pH影响对扩展速率的控制的量。通常，孵育的长度和温度以及溶液pH与扩展控制的量呈正比。孵育结束后，洗去过量的处理溶液，干燥水凝胶材料。
在根据本发明的一些实施方式中，使用非水性溶剂。在此类实施方式中，可使用具有质子化羧酸的单体(例如，丙烯酸或甲基丙烯酸)代替其相应的盐(例如丙烯酸钠或甲基丙烯酸钠)。在非水性溶液中使用这些单体使得无须在低pH溶液中进行随后的处理。
对经交联的水凝胶洗涤之后，对其加以干燥，产生经干燥的水凝胶细丝。长度可在大约0.5cm至大约100cm的范围内，直径可在大约0.010英寸至大约0.100英寸的范围内。在一些实施方式中，需要可推动的栓塞装置。在这些情况下，将经干燥的水凝胶细丝装载到导入管中，包装并灭菌。外科医师获得后，通过线或其它推动器将经干燥的水凝胶细丝推入到微导管或导管中。然后经干燥的水凝胶细丝沿着微导管或导管前进至栓塞位点。
在一种实施方式中，本文所述的水凝胶基本上不含丙烯酰胺。由此，基本上不含丙烯酰胺的水凝胶具有相对于水凝胶质量而言小于1％(w/w％)的丙烯酰胺。在其它一些实施方式中，丙烯酰胺占水凝胶质量的小于大约0.5％或者小于大约0.01％。
在其它一些实施方式中，水凝胶是生物不可再吸收的或者基本上是生物不可再吸收的。在本文中使用时，“生物不可再吸收的”水凝胶是生物相容的，并且在体内不经历正常生化作用导致的破坏。在一种实施方式中，水凝胶基本上是生物不可再吸收的，并且在植入1年后保持超过95％的完整度。在其它一些实施方式中，基本上生物不可再吸收的水凝胶在1年之后保持超过90％的完整度。
在另一实施方式中，水凝胶是可生物再吸收的，这意味着水凝胶生物相容，并且在体内通过正常生化途径破坏。在一种实施方式中，水凝胶是可生物再吸收的，其植入1年后剩余小于5％的完整度。在其它一些实施方式中，水凝胶是可生物再吸收的，其在植入2年后剩余小于5％的完整度。在其它一些实施方式中，水凝胶是可生物再吸收的，其在植入5年后剩余小于5％的完整度。
在根据本发明的另一实施方式中，需要可取回的栓塞装置。在这些情况下，通过粘合、冲模(swaging)或本领域已知的其它手段，向经干燥的水凝胶细丝连接耦合器。耦合器允许与递送推动器相连。与递送推动器相连之后，经干燥的水凝胶细丝/递送推动剂构建体被包装并灭菌。外科医师获得后将装置导入微导管或导管，并使其前进至拴塞位点。外科医师可牵引和使装置前进，直到其被正确定位。此时，外科医师可将经干燥的水凝胶细丝与递送推动器分开，并从微导管或导管上移除递送推动器。
在另一实施方式中，使用流体辅助的可注射栓塞装置。在这种情况下，将经干燥的水凝胶细丝转载进导入器，包装并灭菌。外科医师获得后用填装有盐水或其它生理溶液的注射器将经干燥的水凝胶细丝注射进微导管或导管。除了水合水凝胶细丝之外，使用盐水或其它生理溶液辅助其沿着导管前进。然后采用后需注射，将经干燥的水凝胶细丝沿着微导管或导管前进至栓塞位点。
实施例
下述是本文所述的具有可视试剂的水凝胶的一些生物医药应用的非限制性实施例。但是，应当知道，除了本文所示的特定实施例之外，该材料具有很多其它医药和非医药应用。
实施例1
制备PEG 1000二丙烯酰胺
首先，通过与200mL甲苯共沸蒸馏来干燥18g聚乙二醇(PEG)1000。然后，加入7.0ml三乙胺和4.6mL甲磺酰氯，搅拌4小时。然后过滤溶液，除去盐并蒸发溶剂。将得到的产品加入至150mL 25％氢氧化铵中，搅拌2天。通过与甲苯共沸蒸馏，除去水，干燥产物。将得到的经干燥的PEG二胺溶于20mL二氯甲烷和50mL甲苯中。然后，加入70mL三乙胺和4.9mL丙烯酰氯，在搅拌下进行4小时反应。过滤得到的溶液，除去溶剂，剩下PEG 1000二丙烯酰胺。
实施例2
制备不透辐射单体
首先，在氩气下将9g三碘苯酚溶于150mL二氯甲烷。然后加入3.15mL戊烯酰氯，同时加以搅拌。然后缓慢加入三乙胺，并搅拌4小时。用100mL水洗溶液，蒸发至干，剩下2，4，6-三碘苯基戊-4-烯酸酯。
实施例3
在氯仿中制备不透辐射的水凝胶细丝
为在有机溶剂中制备不透辐射的水凝胶，将2g 2，4，6-三碘苯基戊-4-烯酸酯、0.67g丙烯酸、1.2gPEG二丙烯酰胺400、24mg N，N-亚甲基双丙烯酰胺和75mg偶氮双(2-甲基丙腈)溶于2.5mL氯仿中。然后对溶液喷氩气10分钟，之后使用3cc注射器注射进0.020英寸的聚乙烯管中。在两端对管加热密封，放在80℃烘箱中过夜，以使溶液聚合。
实施例4
制备加载钡的不透辐射水凝胶细丝
为在有机溶剂中制备加载钡的不透辐射的水凝胶，将7g硫酸钡、0.5g丙烯酸、5g聚(四亚甲基氧)二丙烯酰胺1000、1.25g甲基丙烯酸2-羟乙酯、212mg N，N-亚甲基双丙烯酰胺和100mg偶氮双(2-甲基丙腈)溶于3.5mL异丙醇中。然后对溶液喷氩气10分钟，之后使用3cc注射器注射进缠绕在4mm心轴周围的0.010英寸的HYTREL
Figure BPA00001161636800131
管中。在两端对管加热密封，放在100℃水浴中1小时，然后在80℃烘箱中过夜，以使溶液聚合。
实施例5
在水中制备不透辐射的水凝胶细丝
为在水中制备不透辐射的水凝胶，将5g 2，5-丙烯酰氨基-2，4，6-三碘-n，n’-双-(2，3二羟基丙基)异邻苯二甲酰胺、1.33g丙烯酸、2.5g PEG二丙烯酰胺400、50mg n-乙烯基-2-吡咯烷酮和100mg 2，2’偶氮双(2-甲基丙腈)二盐酸盐溶解于10mL水中。然后对溶液喷氩气10分钟，之后使用3cc注射器注射进0.020英寸的聚乙烯管中。在两端对管加热密封，放在80℃烘箱中过夜，以使溶液聚合。
实施例6
对不透辐射的水凝胶细丝进行洗涤和酸处理
对于根据实施例3聚合的水凝胶，将管切为3英寸的段，放进丙酮中1小时。在丙酮中，水凝胶扩展到管的末端之外，令其从管中移出。在丙酮中对水凝胶洗涤2小时。2小时后，更换丙酮，再洗水凝胶2小时。移出水凝胶，在真空烘箱中于50℃对水凝胶干燥2小时。
对于根据实施例4聚合的水凝胶，通过将管溶于苯酚在氯仿中的20％溶液中，移出水凝胶。管溶解后，用氯仿更换苯酚溶液，洗涤1小时。1小时后，更换氯仿，再洗水凝胶1小时。除去氯仿，在真空烘箱中于50℃对水凝胶干燥2小时。为除去任何未反应的单体，将水凝胶放在乙醇中，处理12小时。12小时后，更换乙醇，再洗2小时。2小时后，更换乙醇，再洗水凝胶2小时。除去乙醇，在真空烘箱中对水凝胶干燥12小时。
对于根据实施例5聚合的水凝胶，将管切为3英寸的段，并放进50℃的真空烘箱中6小时。一旦水凝胶干燥，使用心轴将其从管中推出。在水中洗水凝胶2小时。2小时后，更换水，再洗水凝胶2小时。除去水，在真空烘箱中于50℃对水凝胶干燥2小时。
对水凝胶的酸处理由在37℃下在1N盐酸(HCl)中孵育4小时构成。4小时后，倾倒掉酸。在99％异丙醇中对水凝胶孵育1小时，以除去任何剩下的酸。在真空烘箱中于50℃对水凝胶干燥1小时，以除去剩下的异丙醇。
实施例7
将不透辐射的水凝胶细丝与推动器相连
不透辐射的水凝胶细丝可与V-TRAK
Figure BPA00001161636800141
(MicroVention Terumo，Inc.，Aliso Viejo，CA)或水力推动器相连。为将水凝胶与V-TRAK
Figure BPA00001161636800142
推动器相连，将0.0022英寸聚(乙烯)管缝合线穿过耦合器。耦合器由一端中空的钛圆柱及贯通的洞构成。将聚(乙烯)管缝合线打结，使其不能被拉回。使用粘结剂将水凝胶在结的顶部粘合至耦合器。将聚(乙烯)管线的另一端穿进V-TRAK推动器并打结。
为将水凝胶与水力推动器相连，使用弹式(bullet)耦合器。使用粘结剂将凝胶粘合至耦合器，使用热收缩PET管将其与水力推动器相连。
实施例8
测量扭力
为将实施例6的不透辐射水凝胶细丝配置于动脉瘤囊内的能力与其它现有市售弹簧圈加以比较，测定了多种装置的扭力。在该测试中，通过软焊(soldering)或聚(乙烯)收缩管将大约1英寸的装置与大约15寸的海波管(hypo tubing)连起来。构建体的海波管末端与Instron 5543单柱测试系统(用于测量材料的作用力数据的系统)相连。使构建体沿着聚(碳酸酯)模块中的死胡同式通道前进。当装置到达通道底部，其被迫扭曲，测量相应的力。
测试了目前市售的三种弹簧圈系统，将其与实施例6的不透辐射的水凝胶细丝相比较。测试的第一种弹簧圈是HYPERSOFT
Figure BPA00001161636800153
铂弹簧圈。HYPERSOFT
Figure BPA00001161636800154
铂弹簧圈是外直径为0.012英寸、丝尺寸(filar size)为0.002英寸的软铂涂膜弹簧圈(finishing coil)。测试的第二种弹簧圈是MICROPLEX
Figure BPA00001161636800161
铂弹簧圈。MICROPLEX
Figure BPA00001161636800162
铂弹簧圈是外直径为0.010英寸、丝尺寸为0.002英寸的铂填装弹簧圈。HYPERSOFT
Figure BPA00001161636800163
铂弹簧圈和MICROPLEX
Figure BPA00001161636800164
铂弹簧圈是软铂螺旋状弹簧圈，其没有可扩展的水凝胶。测试的第三种弹簧圈是HYDROCOIL
Figure BPA00001161636800165
10系统。HYDROCOIL
Figure BPA00001161636800166
10系统是外直径为0.008英寸、丝尺寸为0.002英寸的铂弹簧圈，其套有可扩展的聚(丙烯酰胺共丙烯酸)水凝胶，并且带有伸长的铂弹簧圈末圈游丝。
不透辐射的水凝胶细丝和HYPERSOFT
Figure BPA00001161636800167
铂弹簧圈(极其软的铂弹簧圈)之间没有观察到显著的扭力差距。该实验证实，不透辐射的水凝胶细丝具有适于拴塞设备的软配置特征。
实施例9
测量弯曲抗性
使用Gurley 4171ET管状样品僵硬度测试器(具有与其测量片相连的5g配重)来获得不扩展的水凝胶样品的弯曲抗性和可注射的铂微弹簧圈的弯曲抗性。样品长度为1英寸。每种三份重复试样的平均值被概括于下表中。
  样品   测量的抗性(mg)
  D-51不透辐射的水凝胶细丝   0.9±0.4
  0.008英寸铂微弹簧圈   0.6±0.2
结果显示不透辐射的水凝胶细丝和铂微弹簧圈之间相对僵硬度的差别极小。结果表明，可使用不透辐射的水凝胶细丝获得可注射的铂弹簧圈的柔性。
实施例10
评估可注射的不透辐射水凝胶细丝
在配有弯折容器的流动模型中，评估从装载有钡的不透辐射水凝胶制备物构建的装置。将流动引导微导管(Boston Scientific Spinnaker 1.5F)放在容器中。使用3cc注射器，将长度范围5cm至30cm的装置经由微导管注射。在导入、牵引、配置和包装方面对装置加以评估。为实现导入、牵引和配置的顺利进行，必须使用3cc注射器没有意外地导入、牵引和配置植入体。为使得包装顺利进行，应当在与0.008英寸铂弹簧圈相似的弯折容器中包装植入体。
  制备物   导入   牵引   配置   包装
  D-51不透辐射水凝胶细丝   顺利   顺利   顺利   顺利
  0.008英寸铂弹簧圈   顺利   顺利   顺利   顺利
结果表明，不透辐射水凝胶细丝可配置进模拟用途的弯折通路，并且与其它拴塞装置(例如铂弹簧圈)的运作一致。
实施例11
在实验性动脉瘤中评估不透辐射的聚合物水凝胶
用不透辐射聚合物细丝来拴塞三处兔弹性蛋白酶动脉瘤。动脉瘤的宽度、长度和颈分别在2.4至3.6mm、4.7至8.8mm以及2.4至4.2mm的范围内。将微导管(Cordis RAPIDTRANSIT
Figure BPA00001161636800171
，Cordis Corporation，MiamiLake，FL)放进动脉瘤囊中。将一至三根不透辐射的水凝胶细丝配置进动脉瘤囊。血管成像显示由于拴塞使得全部三处动脉瘤完全闭塞。拴塞后6周，通过血管成像观察到全部三处动脉瘤完全闭塞。获取动脉瘤并对其进行组织学处理。切片显示动脉瘤囊被不透辐射的水凝胶细丝完全填充，不透辐射的水凝胶细丝之间的缝隙中纤维组织正组织化或已组织化，以及由巨噬细胞和一些巨细胞构成的炎性应答。这些结果表明，不透辐射的水凝胶细丝可配置进实验性的动脉瘤，并且引发与其它拴塞装置一致的外来体应答。
除非另有指明，用于说明书和权利要求中表达成分的量、性质(例如分子量)、反应条件等的所有数字都应当理解为在所有情况下都被“大约”所修饰。因此，如果没有相反指明，说明书和所附权利要求中示出的数字参数是约数，其可根据本发明意欲获得的期待性质而变化。至少，并且在不欲限制等同原则适用于权利要求保护范围的情况下，每个数字参数应当至少根据所报道的有效位数的数值并且应用普通取整技术来解释。尽管本发明宽广范围中示出的数值范围和参数是约数，但具体实施例中示出的数值是尽可能精确地报道的。但是任何数值必然固有含有一定误差，这是其各自测试手段中发现的标准偏差导致的。
除非本文另有指明或上下文中明显矛盾，描述本发明的上下文(尤其是所附权利要求的上下文中)中使用的术语“一个/种”、“这个/这种”(“a”、“an”和“the”)和相似指代应当被解释为既包括单数又包括复数。本文中提到值的范围仅仅是作为分别提到落在该范围内的每个单独的值的速记方法。除非本文另有指明，每个分别的值都像它们在本文中被分别提到那样包括在说明书中。除非本文另有指明或上下文中明显矛盾，本文所述的所有方法可以以任何合适的顺序进行。使用本文中提供的任何和全部例子或示例性语言(例如“例如”)仅仅是为了更好阐述本发明，其并非对另外要求保护的本发明的范围加以限制。说明书中任何语言都不应被解释为指代对本发明的实践来说必要的任何没有要求保护的元件。
对本文公开的本发明的替代性元件或实施方式的分组不应被解释为限制。每个组的成员可单独被提到或要求保护，或者可与本文中发现的其它元件或组中的其它元件进行任何组合。预计到，为了方便和/或可专利性的理由，组中的一个或多个成员可被包括进组或从组中删除。当此类包括或删除发生时，说明书被理解为含有经修改的组，由此满足所附权利要求中使用的所有马库什族的书面描述。
本文中描述了本发明的某些实施方式，包括专利人已知的用于开展本发明的最佳模式。当然，在阅读说明书前文之后，对描述的这些实施方式的改变对于本领域技术人员来说是明显的。发明人预期，技术人员能合适地利用此类改变，发明人意欲使得本发明可按照与本文特定描述有所不同的方式实践。因此，本发明包括适用法律所允许的对所附权利要求中提到的所有主题的所有改良和等同体。此外，除非本文另有指明或上下文中明显矛盾，本发明包括上述元件的所有可能的改变形式的任何组合。
此外，本说明书通篇中提到了数篇专利和公开出版物。上述参考文献和公开出版物各自通过引用整体并入本文。
最后，应当理解，本文所述的本发明的实施方式是为了阐述本发明的原理。可利用的其它改良也在本发明的范围内。因此，举例而言，但非限制，可根据本文教导，利用本发明的替代性构造。因此，本发明不应限于精确示出和描述的那些内容。
可使用由……构成或基本上由……构成这样的语言，在权利要求中对本文公开的特定实施方式进行进一步限制。当用于权利要求中时，无论是原来提交的或者根据修改添加的，术语“由……构成”排除权利要求中没有指出的任何元件、步骤或成分。术语“基本上由……构成”将权利要求的范围限制为指出的材料或步骤以及不会对基本的和新颖的特征造成重大影响的那些。要求保护的本发明的实施方式被固有地或明确地描述于本文中，并且能够被实施。

Claims (26)

1.用于植入的装置，所述装置包含：
双功能的、低分子量烯属不饱和的可塑形大单体；
烯属不饱和单体；和
可视试剂，
其中所述装置不含支撑构件。
2.根据权利要求1的装置，其中所述大单体具有大约100克/摩尔至大约5000克/摩尔的分子量。
3.根据权利要求1的装置，其中所述水凝胶是环境应答性的。
4.根据权利要求1的装置，其中所述大单体包含聚乙二醇、丙二醇、聚(四亚甲基氧)、聚(乙二醇)二丙烯酰胺、聚(乙二醇)二丙烯酸酯、聚(乙二醇)二甲基丙烯酸酯、其衍生物或其组合。
5.根据权利要求1的装置，其中所述烯属不饱和单体包含一个或多个可离子化官能团。
6.根据权利要求1的装置，其中所述烯属不饱和单体包含N，N’-亚甲基双丙烯酰胺、N-乙烯基吡咯烷酮、甲基丙烯酸-2-羟乙酯、其衍生物或其组合。
7.根据权利要求1的装置，其中所述可视试剂包含具有单个不饱和点和至少一个碘原子的芳香族环。
8.根据权利要求1的装置，其中所述可视试剂包含钆或铁的氧化物。
9.根据权利要求1的装置，其中所述烯属不饱和单体和所述可视元件包含2，4，6-三碘苯基戊-4-烯酸酯、5-丙烯酰氨基-2，4，6-三碘-n，n’-双-(2，3二羟基丙基)异邻苯二甲酰胺、其衍生物或其组合。
10.根据权利要求1的装置，其中所述大单体和单体采用N，N，N’，N’-四甲基乙二胺、过硫酸铵、偶氮二异丁腈、过氧化苯甲酰、2，2’-偶氮双(2-甲基丙脒)二盐酸盐、其衍生物或其组合交联。
11.根据权利要求1的装置，其中所述可离子化的官能团包含酸性基团或碱性基团。
12.根据权利要求11的装置，其中所述可离子化的官能团包含胺基团、其衍生物或其组合。
13.根据权利要求11的装置，其中所述酸性基团包含羧酸、其衍生物或其组合。
14.根据权利要求1的装置，其中所述水凝胶基本不含丙烯酰胺。
15.根据权利要求1的装置，其中所述水凝胶基本上是生物不可再吸收的。
16.根据权利要求1的装置，其中所述水凝胶是生物可再吸收的。
17.制备用于植入动物的装置的方法，所述方法包括：
a)将双功能的、低分子量烯属不饱和的可塑形大单体，烯属不饱和单体，可视试剂和溶剂组合起来，制备前聚合物溶液；和
b)处理所述前聚合物溶液，制备可在生理条件下扩展的水凝胶。
18.根据权利要求17的方法，其中所述溶剂包含水、二氯甲烷、丙酮、异丙醇、乙醇或其组合。
19.根据权利要求17的方法，其中所述双功能的、低分子量烯属不饱和的可塑形大单体具有大约100克/摩尔至大约5000克/摩尔的分子量。
20.根据权利要求17的方法，其中所述烯属不饱和单体包含可离子化的官能团。
21.根据权利要求17的方法，其中所述溶剂占所述前聚合物溶液大约20％w/w至大约80％w/w。
22.根据权利要求17的方法，其中所述单体占所述前聚合物溶液重量的大约40％至大约80％。
23.根据权利要求17的方法，其中所述方法还包含向所述前聚合物溶液中加入第二烯属不饱和单体的步骤。
24.根据权利要求17的方法，其中所述可离子化的官能团包含碱性基团，所述处理步骤包含在高于所述碱性基团的pKa的pHs下对所述碱性基团进行去质子化，或者在低于所述碱性基团的pKa的pHs下对所述碱性基团进行质子化。
25.根据权利要求17的方法，其中所述可离子化的官能团包含酸性基团，所述处理步骤包含在低于所述酸性基团的pKa的pHs下对所述酸性基团进行质子化，或者在高于所述酸性基团的pKa的pHs下对所述酸性基团进行质子化。
26.在动物中用于植入的装置，所述装置包含：
双功能的、低分子量烯属不饱和的可塑形大单体，其分子量为大约100克/摩尔至大约5000克/摩尔；
烯属不饱和单体；和
可视试剂，
其中，所述装置不含金属性支撑构件。
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US9486221B2 (en) 2016-11-08
US20130253087A1 (en) 2013-09-26
EP2266639B1 (en) 2016-10-05
CN101903051B (zh) 2013-07-31
JP5698537B2 (ja) 2015-04-08
EP2266639A1 (en) 2010-12-29
WO2009086208A2 (en) 2009-07-09
AU2008345590B2 (en) 2014-10-30
CA2709379C (en) 2016-08-16
EP2231215A2 (en) 2010-09-29
JP2011507637A (ja) 2011-03-10

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