CN101500623B - 一种由可膨胀聚合物构成的栓塞器械 - Google Patents
一种由可膨胀聚合物构成的栓塞器械 Download PDFInfo
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Abstract
本发明涉及一种用于阻塞体腔的器械,例如用于栓塞化血管动脉瘤等,并且涉及制造和使用上述器械的方法。所述器械具有新型的可膨胀材料、新型的内部构造或二者。所提供的器械非常柔软且能够使配备对身体组织、导管、体腔等的损害较轻或没有损害。
Description
相关申请的交叉引用
本申请要求于2006年6月15日递交的美国临时专利申请60/814,309的优先权。
技术领域
本发明涉及一种用于阻塞体腔的器械,例如用于栓塞血管动脉瘤等,并且涉及制造和使用上述器械的方法。
背景技术
在众多临床情形下需要通过栓塞术来阻塞体腔、血管和其它腔。例如,为了绝育目的,阻塞输卵管,以及阻塞修复心脏缺损,诸如卵圆孔未闭、动脉导管未闭、和左心耳以及心房间隔缺损。在上述情形下,阻塞器械的作用在于,基本上阻断或抑制体液流入或穿过洞、腔、脉管、腔隙或缺损,从而对患者的治疗有益。
在众多临床情形下,还需要栓塞血管。例如,使用血管栓塞术,从而控制血管出血、阻塞血液供入肿瘤和阻塞血管动脉瘤,具体阻塞颅内动脉瘤。近年来,用于治疗动脉瘤的血管栓塞术受到许多关注。现有技术中出现了数种不同的治疗方式。一种具有前景的方法是,使用血栓形成微型线圈(thrombogenic microcoil)。这些微型线圈可以由生物相容性金属合金(通常是不透射线材料,诸如铂或钨)或适当的聚合物制成。如下专利中公开了微型线圈的实例:Ritchart等的U.S.Pat.No.4,994,069、Butler等的U.S.Pat.No.5,133,731、Chee等的U.S.Pat.No.5,226,911、Palermo的U.S.Pat.No.5,312,415、Phelps等的U.S.Pat.No.5,382,259、Dormandy,Jr.等的U.S.Pat.No.5,382,260、Dormandy,Jr等的U.S.Pat.No.5,476,472、Mirigian的U.S.Pat.No.5,578,074、Ken的U.S.Pat.No.5,582,619、Mariant的U.S.Pat.No.5,624,461、Horton的U.S.Pat.No.5,645,558、Snyder的U.S.Pat.No.5,658,308和Berenstein等的U.S.Pat.No.5,718,711,所有这些专利通常引用***本文。
获得一定成功的一种特定类型的微型线圈是Guglielmi Detachable Coil("GDC"),其在Guglielmi等的U.S.Pat.No.5,122,136中有描述。GDC通过焊料连接将铂线圈固定在不锈钢输送管线上。在线圈置于动脉瘤内后,对输送管线施加电流,这以电解方式分解焊料接头,从而使线圈与输送管线脱离。施加电流还使线圈产生正电荷,其吸引带负电的血细胞、血小板和纤维蛋白原,从而增加了线圈的血栓形成性。将数种具有不同直径和长度的线圈填充到动脉瘤中,直至将动脉瘤完全装满。因此,线圈在动脉瘤中产生并保留血栓,从而抑制其移动和分解。
如下专利列举了微型线圈血管阻塞器械领域中的最近发展情况:Greene,Jr等的U.S.Pat.No.6,299,619、Greene,Jr.等的U.S.Pat.No.6,602,261和Martinez的共同待审美国专利申请10/631,981,这些专利转让给这些专利的受让人,并通过引用***本文。这些专利公开了血管阻塞器械,其包括微型线圈以及设置在所述线圈外表面上的一种或多种可膨胀元件。所述可膨胀元件可以由各种可膨胀聚合水凝胶中的任意一种形成,或者可以由各种环境敏感聚合物中的任意一种形成,所述环境敏感聚合物当暴露于诸如血流的生理学环境中时响应环境参数(例如温度或pH)的改变会发生膨胀。
本发明涉及一种新型的血管阻塞器械,一种新型的可膨胀元件及其组合。
发明内容
本发明涉及一种新型的血管阻塞器械,其包括载体构件、新型的可膨胀元件及其组合。一般而言,可膨胀元件包括可膨胀聚合物。载体构件可以通过提供如下结构来协助可膨胀元件的输送:在一些实施方式中,所述结构允许偶合到输送机构上,在一些实施方式中,所述结构增强器械的不透射线性。
在一个实施方式中,所述可膨胀聚合物是环境敏感聚合水凝胶,诸如在2005年4月12日授权的Cruise等的美国专利6,878,384中描述的那些,该专利通过引用***本文。在另一实施方式中,可膨胀聚合物是由丙烯酸钠和聚(乙二醇)衍生物组成的新型水凝胶。在另一实施方式中,可膨胀聚合物是包括衍生物的水凝胶。
在一个实施方式中,可膨胀聚合物是一种新型的水凝胶,其具有可离子化的官能团,并由大单体制成。所述水凝胶可以具有环境响应性,且具有约0.1毫克至约85毫克的未膨胀抗弯强度(unexpanded bendingresistance)。大单体可以是非离子的,并且/或者可以是烯属不饱和的。
在另一实施方式中,大单体可以具有约400至约35000、更优选约5000至约15000,甚至更优选约8500至约12000的分子量。在另一实施方式中,水凝胶可以由聚醚、聚氨酯、其衍生物或其组合制成。在另一实施方式中,可离子化官能团可以包括碱性基团(例如胺、其衍生物或其组合)或酸性基团(例如羧酸、其衍生物或其组合)。如果可离子化官能团包括碱性基团,那么碱性基团可以在高于所述碱性基团的pKa的pH下去质子化,或者在低于所述碱性基团的pKa的pH下质子化。如果可离子化官能团包括酸性基团,那么酸性基团可以在低于所述酸性基团的pKa的pH下质子化,或者在高于所述酸性基团的pKa的pH下去质子化。
在另一实施方式中,大单体可以包括聚(乙二醇)的乙烯基、丙烯酸酯、丙烯酰胺或甲基丙烯酸酯衍生物,或其组合。在另一实施方式中,大单体可以包括聚(乙二醇)二丙烯酰胺。在另一实施方式中,大单体基本上没有,更优选没有,未经键合的丙烯酰胺。
在另一实施方式中,大单体可以与含有至少两个烯属不饱和基团的化合物交联。烯属不饱和化合物的实例包括,N,N’-亚甲基二丙烯酰胺、其衍生物或其组合。在另一实施方式中,水凝胶可以采用聚合引发剂来制备。适当的聚合引发剂的实例包括,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、其衍生物或其组合。聚合引发剂可以溶于水性或有机溶剂中。例如,偶氮二异丁腈不溶于水,但可用偶氮二异丁腈的水溶性衍生物,诸如2,2’-偶氮二(2-甲基丙酰脒(proprionamidine))二盐酸盐。在另一实施方式中,所述水凝胶在生理学条件下基本上不可再吸收、不可降解或二者。
在另一实施方式中,本发明包括一种用于制备具有环境响应性、植入动物中的水凝胶的方法。所述方法包括,将至少一种具有至少一个烯属不饱和基团的大单体(优选非离子)、至少一种具有至少一个离子化官能团和至少一个烯属不饱和基团的大单体或单体、至少一种聚合引发剂和至少一种溶剂组合,从而形成水凝胶。所述溶剂可以包括水性溶剂或有机溶剂或其组合。在另一实施方式中,所述溶剂是水。接着,可以对所述水凝胶进行处理,以制备具有环境响应性的水凝胶,优选制备在生理学条件下具有响应性的水凝胶。可离子化官能团可以是酸性基团(例如羧酸、其衍生物或其组合)或碱性基团(例如胺、其衍生物或其组合)。如果可离子化官能团包括酸性基团,那么处理步骤可以包括将水凝胶在酸性环境中进行培养以使酸性基团质子化。如果可离子化官能团包括碱性基团,那么处理步骤可以包括将水凝胶在碱性环境中进行培养以使碱性基团去质子化。在某些实施方式中,优选的是,在植入动物中后,酸性基团能够去质子化,或者相反碱性基团能够质子化。
在另一实施方式中,烯属不饱和大单体可以具有乙烯基、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。在另一实施方式中,烯属不饱和大单体以聚(乙二醇)、其衍生物或其组合为基础。在另一实施方式中,烯属不饱和大单体是聚(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,烯属不饱和大单体是聚(乙二醇)二丙烯酰胺。所用烯属不饱和大单体的浓度可为约5重量%至约40重量%,优选为约20重量%至约30重量%。所用溶剂的浓度可为约20重量%至约80重量%。
在另一实施方式中,组合步骤还包括添加至少一种交联试剂,所述交联试剂包括烯属不饱和化合物。在本发明的某些实施方式中,交联剂不是必需的。换句话说,可以采用具有多个烯属不饱和基团的大单体来制备水凝胶。在另一实施方式中,聚合引发剂可以氧化-还原聚合引发剂。在另一实施方式中,聚合引发剂可以是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’-偶氮二(2-甲基丙酰脒)二盐酸盐、其衍生物或其组合。在另一实施方式中,组合步骤进一步包括添加成孔剂(porosigen)。
在另一实施方式中,烯属不饱和大单体包括聚(乙二醇)二丙烯酰胺;具有至少一个可离子化基团和至少一个烯属不饱和基团的大单体、单体或聚合物包括丙烯酸钠;聚合引发剂包括硫酸铵和N,N,N’,N’-四甲基乙二胺;溶剂包括水。
在另一实施方式中,烯属不饱和大单体可以具有约400至约35000g/mol、更优选约2000至约25000g/mol、甚至更优选约5000至约15000g/mol、甚至更优选约8000至约12500g/mol、甚至更优选8500至约12000g/mol的分子量。在另一实施方式中,具有环境响应性的水凝胶在生理学条件下基本上不可再吸收、或不可降解或二者。在某些实施方式中,具有环境响应性的水凝胶基本上没有或完全没有未经键合的丙烯酰胺。
在一个实施方式中,载体构件包括由金属、塑料或类似材料制成的线圈或微型线圈。在另一实施方式中,载体构件包括由金属、塑料或类似材料制成的编织物或针织物。在另一实施方式中,载体构件包括具有多个切口或凹槽(切入管子中)的塑料或金属管。
在一个实施方式中,可膨胀元件在载体构件中基本同轴排列。在另一实施方式中,抗拉伸构件与膨胀元件平行排列。在另一实施方式中,抗拉伸构件围绕膨胀元件进行包裹、打结或捻合。在某些实施方式中,抗拉伸构件位于可膨胀元件内。
在一个实施方式中,包括可膨胀元件和载体构件的器械以可拆卸方式偶合到输送***上。在另一实施方式中,所述器械被配置成通过导管推入或注射入体内来进行输送。
在一个实施方式中,可膨胀元件具有环境敏感性,当暴露于体液中时显示延迟膨胀。在另一实施方式中,可膨胀元件当与体液接触时快速膨胀。在另一实施方式中,可膨胀元件包括多孔或网状结构,其可用于形成用于细胞生长的表面或支架。
在一个实施方式中,可膨胀元件膨胀至尺寸大于载体构件的直径,从而提高对损伤的填充。在另一实施方式中,可膨胀元件膨胀至尺寸等于或小于载体构件的直径,从而为细胞生长、治疗剂(诸如药物、蛋白质、基因、诸如纤维蛋白的生物化合物等)的释放提供支架。
附图说明
图1是示出了本发明的一个实施方式在可膨胀元件膨胀前的透视图。
图2是示出了与图1类似的器械处于膨胀态的透视图。
图3是本发明的另一实施方式的透视图。
图4是另一实施方式的透视图,其中载体构件包括有孔的管子、编织物或针织物。
图5是另一实施方式的透视图,所述实施方式包含一个几乎与可膨胀元件平行延伸的抗拉伸构件。
图6是另一实施方式的透视图,所述实施方式包含一个几乎与可膨胀元件缠绕的抗拉伸构件。
图7是另一实施方式的透视图,其中,可膨胀元件在载体构件外部形成弯曲或弯折。
图8是示出了与图1和图2所示那些类似的器械的另一实施方式的透视图,其中可膨胀元件未膨胀至直径大于载体构件。
具体实施方式
本文中所用术语“大单体”指含有至少一个活性聚合位点或键合位点的大分子。大单体的分子量大于单体。例如,丙烯酰胺单体的分子量约为71.08g/mol,而聚(乙二醇)二丙烯酰胺大单体的分子量可以约为400g/mol或更高。优选的大单体是非离子的,即在所有pH下它们都不会变化。
本文中所用术语“环境响应性”指,材料(例如水凝胶)对环境中的变化(包括但不限于pH、温度和压力)敏感。适于在本发明中使用的一些可膨胀材料在生理学条件下具有环境响应性。
本文中所用术语“不可再吸收”指,材料(例如水凝胶)不能容易地和/或基本上不能被降解和/或被身体组织吸收。
本文中所用术语“未膨胀”指如下状态,在该状态下,水凝胶基本上未被水合,因而未膨胀。
本文中所用术语“烯属不饱和”指化学个体(例如大单体、单体或聚合物)含有至少一个碳碳双键。
本文中所用术语“抗弯强度”指,当样品(例如未膨胀的水凝胶)在提供阻力的臂或叶片上稳定地、均匀地移动时,由其显示的抵抗力。在样品弯曲并解除提供阻力的臂或叶片的时刻,测量提供阻力的臂或叶片的最大位移。利用适于该机器的换算关系、校准关系和阻力(例如重量)的量(如果有的话,与提供阻力的臂或叶片相关联),将该最大位移换算成弯曲“抵抗力”或“挺度”。本文中,抗弯强度的量度单位是毫克(mg),基本上是弯曲样品所需的力的大小。
参照图1-8,本发明是一种器械,其包括可膨胀元件1和载体构件2。可膨胀元件1可由各种适当的生物相容性聚合物制成。在一个实施方式中,可膨胀元件1由可生物吸收或可生物降解的聚合物制成,例如美国专利7,070,607和6,684,884中描述的那些,上述专利公开的内容通过引用***本文。在另一实施方式中,可膨胀元件1由软质保形材料制成,更优选由诸如水凝胶的可膨胀材料制成。
在一个实施方式中,形成可膨胀元件1的材料是具有环境响应性的水凝胶,诸如美国专利6,878,384中描述的那些,该专利公开的内容通过引用***本文。具体地,美国专利6,878,384中描述的水凝胶响应于诸如pH或温度的环境参数的变化而进行可控体积膨胀。这些水凝胶通过形成液体混合物来制备,所述液体混合物包含(a)至少一种单体和/或聚合物,其中的至少一部分对环境参数的变化敏感;(b)交联剂;和(c)聚合引发剂。如果需要,可以将成孔剂(例如NaCl、冰晶或蔗糖)加入混合物中,然后将其从所得固体水凝胶中除去,从而为水凝胶提供足够的孔隙率以允许细胞向内生长。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提供可控的膨胀速率。例如,如果丙烯酸被掺入交联网络中,那么将水凝胶在低pH溶液中进行培养,从而使羧酸基团质子化。在冲洗掉多余的低pH溶液且水凝胶干燥后,可以通过填充生理学pH下的盐水或血液的微导管引入水凝胶。水凝胶直到羧酸基团去质子化才能膨胀。相反,如果将含胺的单体掺入交联网络,那么在高pH溶液中对水凝胶进行培养,以使胺去质子化。在冲洗掉多余的高pH溶液且水凝胶干燥后,可以通过填充生理学pH下的盐水或血液的微导管引入水凝胶。水凝胶直到氨基质子化才能膨胀。
在另一实施方式中,形成可膨胀元件1的材料可以是具有环境响应性的水凝胶,其类似于美国专利6,878,384中描述的那些;然而,烯属不饱和大单体(优选为非离子)替代或补充至少一种单体或聚合物。申请人惊讶地发现,在这个实施方式中制备的水凝胶处于未膨胀状态时比根据美国专利6,878,384制备的那些水凝胶更柔软且/或更柔韧。实际上,根据这个实施方式制备的水凝胶可以具有约0.1mg至约85mg、约0.1mg至约50mg、0.1mg至约25mg、约0.5mg至约10mg或约0.5mg至约5mg的未膨胀抗弯强度。本申请人还发现,使用烯属不饱和、非离子大单体(例如,聚(乙二醇)及其衍生物)不仅可以制备更柔软的未膨胀水凝胶,而且与含有可离子化基团的单体或聚合物组合后可以对其进行处理,从而获得环境响应性。未膨胀柔韧性惊人地提高,使得水凝胶例如在动物中更易于配备,或者配备对身体组织、导管、体腔等的损害较轻或没有损害。
由非离子大单体与具有可离子化官能团的单体或聚合物的组合制备的水凝胶能够响应于环境参数的变化而进行可控体积膨胀。这些水凝胶可以通过如下制备:在溶剂的存在下将(a)至少一种具有多个烯属不饱和基团的大单体(优选非离子);(b)具有至少一个可离子化官能团和至少一个烯属不饱和基团的大单体、聚合物或单体;(c)聚合引发剂进行组合。值得注意的是,采用这种类型的水凝胶,交联剂对于交联不是必需的,因为在某些实施方式中所选择的组分足以形成水凝胶。如上文所述,可以将成孔剂加入混合物中,然后将其从所得水凝胶中去除,从而为水凝胶提供足够的孔隙率以允许细胞向内生长。
可以通过掺入至少一种具有至少一个可离子化官能团(例如,胺、羧酸)的大单体、聚合物或单体,从而为含有非离子大单体的水凝胶提供可控的膨胀速率。如上所述,如果官能团是酸,那么将水凝胶在低pH溶液中进行培养,以使该基团质子化。在冲洗掉多余的低pH溶液且水凝胶干燥后,可以通过微导管(优选被盐水填充)引入水凝胶。水凝胶直到酸基去质子化才能膨胀。与此相反,如果官能团是胺,那么将水凝胶在高pH溶液中进行培养以使该基团去质子化。在冲洗掉多余的高pH溶液且水凝胶干燥后,可以通过微导管(优选被盐水填充)引入水凝胶。水凝胶直到胺基质子化才能膨胀。
更具体地,在一个实施方式中,水凝胶通过如下制备:将至少一种具有至少一个不饱和基团的非离子大单体、至少一种具有至少一个可离子化官能团和至少一个烯属不饱和基团的大单体、单体或聚合物、至少一种聚合引发剂和溶剂进行组合。可选地,还可以掺入烯属不饱和交联剂和/或成孔剂。非离子大单体在溶剂中的浓度优选在约5%至约40%(w/w)的范围内,更优选在约20%至约30%(w/w)的范围内。优选的非离子大单体是聚(乙二醇)、其衍生物及其组合。衍生物包括,但不限于,聚(乙二醇)二丙烯酰胺、聚(乙二醇)二丙烯酸酯和聚(乙二醇)二甲基丙烯酸酯。聚(乙二醇)二丙烯酰胺是优选的聚(乙二醇)衍生物,其分子量在约8500至约12000范围内。大单体的聚合位点可以小于20个,更优选小于10个,更优选约5个或更少,更优选约2至约4个。聚(乙二醇)二丙烯酰胺具有两个聚合位点。
优选的具有至少一个可离子化官能团的大单体、聚合物或单体包括,但不限于,具有羧酸或氨基基团的化合物、其衍生物或其组合。丙烯酸钠是优选的含有可离子官能团的化合物,其分子量为94.04g/mol。可离子化大单体、聚合物或单体在溶剂中的浓度优选在约5%至约40%(w/w)的范围内,更优选在约20%至约30%(w/w)的范围内。所选择的可离子化大单体、聚合物或单体中的至少一部分,优选约10%-50%,更优选约10%-30%,应当是pH敏感的。优选的是,没有游离丙烯酰胺被用在本发明的含有大单体的水凝胶中。
如果使用的话,交联剂可以是任何多官能烯属不饱和化合物,优选为N,N’-亚甲基二丙烯酰胺。如果需要水凝胶材料可生物降解,那么可以选择可生物降解的交联剂。交联剂在溶剂中的浓度应当低于约1%w/w,优选低于约0.1%(w/w)。
如上所述,如果添加溶剂,那么可以根据所用大单体、单体或聚合物、交联剂、和/或成孔剂的溶解性来选择溶剂。如果使用液体大单体、单体或聚合物溶液,那么溶剂不是必需的。优选的溶剂是水,但是可以使用各种水性和有机溶剂。溶剂的浓度优选在约20%至约80%(w/w)的范围内,更优选在约50%至约80%(w/w)的范围内。
可以通过改变大单体、单体或聚合物的浓度、大单体的分子量、溶剂浓度和交联剂(如果使用的话)浓度来调整交联密度。如上所述,可以通过氧化-还原、辐射和/或加热对水凝胶进行交联。优选类型的聚合引发剂是通过氧化-还原起作用的引发剂。适当的聚合引发剂包括,但不限于,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’-偶氮二(2-甲基丙酰脒)二盐酸盐、其衍生物或其组合。过硫酸铵和N,N,N’,N’-四甲基乙二胺的组合是优选的用在本发明的含有大单体的实施方式中的聚合引发剂。
聚合完成后,可以采用水、醇或其它适当的洗涤溶液对本发明的水凝胶进行洗涤,从而除去任何成孔剂,任何未反应、残余的大单体、单体和聚合物以及任何未结合的低聚物。优选地,最初在蒸馏水中对水凝胶进行洗涤来实现上述操作。
如上所述,将水凝胶网络中存在的可离子化官能团进行质子化或去质子化,从而使本发明的水凝胶具有环境响应性。一旦已制成水凝胶并对其进行了洗涤(如果需要的话),那么可以对水凝胶进行处理以使水凝胶具有环境响应性。对于其中可离子化官能团是羧酸基团的水凝胶网络,将水凝胶在低pH溶液中进行培养。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。培养持续的时间和培养温度以及溶液的pH会影响对膨胀速率的控制量。一般而言,培养持续的时间和培养温度与膨胀控制量成正比,而培养溶液的pH与其成反比。
已确定,培养溶液的水含量也会影响膨胀控制。在这一方面,水含量越高,能够使水凝胶膨胀越大,其被认为提高了易受质子化影响的羧酸基团的数量。在最大程度上对膨胀速率进行控制需要对水含量和pH进行优化。膨胀控制等对器械的定位/复位时间具有影响。通常,对于本发明的水凝胶器械来说,定位/复位时间为约0.1至约30分钟是优选的。
培养后,洗掉过量的处理溶液,并干燥水凝胶材料。已观察到,采用低pH溶液处理的水凝胶变干后,尺寸小于未经处理的水凝胶。这个结果是理想的,因为含有水凝胶的器械可以通过微导管输送。
对于其中可离子化官能团是氨基的水凝胶网络,将水凝胶在高pH溶液中进行培养。与羧酸官能团不一样,水凝胶网络的氨基在高pH下发生去质子化。除了培养溶液的pH以外,该培养在与含羧酸水凝胶类似的条件下实施。换句话说,培养持续的时间和培养温度以及溶液的pH与膨胀控制量成正比。完成培养后,洗涤过量的处理溶液,并干燥水凝胶材料。
在优选的实施方式中,可膨胀元件1是由如下组成的可膨胀水凝胶:(a)至少一种具有至少两个可交联基团的烯属不饱和大单体、单体或聚合物(优选为非离子);(b)至少一种具有至少一个可交联基团和至少一个对环境参数的改变敏感的基团的单体和/或聚合物;(c)聚合引发剂。在一些实施方式中,单体和聚合物可以是可水溶的,而在其它实施方式中,它们可以是不可水溶的。适用于组分(a)和(b)的聚合物包括,聚(乙二醇)、聚(氧化乙烯)、聚(乙烯醇)、聚(氧化丙烯)、聚(丙二醇)、聚(氧化乙烯)-共聚-聚(氧化丙烯)、聚(乙烯基吡咯烷酮)、聚(氨基酸)、葡聚糖、聚(乙基噁唑啉)、多糖、蛋白质、葡糖氨基葡聚糖和碳水化合物及其衍生物。优选的聚合物是聚(乙二醇)(PEG),其尤其适用于组分(a)。或者可以使用可部分生物降解或可完全生物降解的聚合物。
一个实施方式包括,在溶剂的存在下,将(a)约5%至约40%的非离子、烯属不饱和大单体、单体或聚合物;(b)约5%至约40%的具有至少一个可离子化官能团的烯属不饱和单体或聚合物;和(c)聚合引发剂组合。适当的可离子化、烯属不饱和单体包括丙烯酸和甲基丙烯酸以及其衍生物。具有至少一个可离子化官能团的一种适当单体是丙烯酸钠。具有两个烯属不饱和基团的适当大单体包括,聚(乙二醇)二丙烯酸酯和聚(乙二醇)二丙烯酰胺,和聚(乙二醇)二丙烯酰胺,它们的分子量在400至30000g/mol的范围内。使用具有多个烯属不饱和基团的大单体,则可以不使用交联剂,因为多官能聚合物起到了交联剂的作用。在一个实施方式中,水凝胶包括,约5%至约40%的丙烯酸钠,约5%至约40%的聚(乙二醇)二丙烯酸酯,余量为水。
丙烯酸钠/聚(乙二醇)二丙烯酰胺水凝胶用于增强前述具有环境响应性的水凝胶的机械性质。因为丙烯酸钠/聚(乙二醇)二丙烯酰胺水凝胶比丙烯酸钠/丙烯酰胺水凝胶(例如由Micro Vention,Aliso Viejo,CA制造在Hydrogel Embolic System(HES)中使用的水凝胶)更柔软,因此包括该水凝胶的器械可以更柔韧。由于HES相对僵硬,因此MircoVention建议通过浸泡在温热液体中或蒸煮植入体对器械进行预软化。另外,由丙烯酰胺制成的器械在预软化前相对较直,这是因为以丙烯酰胺为基础的水凝胶的僵硬度妨碍载体构件(用于HES,微型线圈)呈现二级构型。为了形成在载体构件2或类似载体构件中经热固(heat-set)的二级构型,由丙烯酸钠/聚(乙二醇)二丙烯酰胺水凝胶制成的器械不需预软化技术,例如浸泡在诸如盐水或血液的温热液体中,或暴露于蒸汽。因此,在例如包括丙烯酸钠和聚(乙二醇)二丙烯酰胺的实施方式中,如图1所示被置于载体构件2的腔体3中、或者如Martinez‘981申请和Greene‘261所示被置于载体元件上的基本上连续长的水凝胶将在载体构件中形成预形成的二级构型,而无需预处理(例如暴露于蒸汽、液体或血液)。这使得该器械更易使用,因为允许去除预处理步骤,且器械当被配备给患者时更安全,因为较软器械对损伤造成的损害可能更少。
实施例
将3g丙烯酰胺、1.7g丙烯酸、9mg双丙烯酰胺、50mg N,N,N’,N’-四甲基乙二胺、15mg过硫酸铵和15.9g水在0.020英寸的管子中组合并聚合。根据美国专利6,878,384,从管子中取出管式聚合物以制备水凝胶1。
将4.6g聚(乙二醇)二丙烯酰胺、3.3g丙烯酸钠、100mg N,N,N’,N’-四甲基乙二胺、25mg过硫酸铵和15.9g水在0.020英寸的管子中组合并聚合。从管道中取出管式聚合物以制备水凝胶2(根据本发明含有大单体的水凝胶实施方式)。
制备与水凝胶2相同的水凝胶,但是根据本发明对其进行额外的酸处理从而制备水凝胶2-酸。
大型的铂微型线圈具有0.014英寸的外径和0.0025英寸的细丝(filar)。小型的铂微型线圈具有0.010英寸的外径和0.002英寸的细丝。
采用Gurley 4171管状样品挺度测量仪得到未膨胀水凝胶样品的抗弯强度和微型线圈的抗弯强度,所述测量仪的测量叶片上连有5克砝码。样品长度为1英寸。下表总结了对每个样品重复5次得到的平均测量阻力和标准差。
样品 | 测定的阻力,毫克 |
水凝胶1 | 88±13 |
水凝胶2 | 23±1 |
水凝胶2-酸 | 1±0 |
大型铂线圈 | 5±1 |
小型铂线圈 | 2±1 |
结果表明,第一种生成的水凝胶1(HES)、第二种生成的含有大单体的水凝胶2、酸处理后的第二种生成的含有大单体的水凝胶2以及微型线圈之间的相对挺度具有较大差异。水凝胶1的挺度几乎是大型铂微型线圈的20倍,而水凝胶2的挺度不到大型铂微型线圈的5倍。经酸处理的水凝胶2的挺度低于大型铂微型线圈,几乎等于小型铂微型线圈。本领域技术人员将认识到,可以通过本发明公开的方法和材料得到更柔韧、未膨胀的含大单体水凝胶。当在医疗器械中使用时,这些水凝胶也可以得到更柔韧的医疗器械。
在另一实施方式中,单体被用于赋予可膨胀元件如下基团,这些基团适于偶合生物活性化合物,例如消炎试剂,诸如皮质类固醇(***(prednisone)和***(dexamethasone));或血管扩张剂,诸如一氧化二氮或肼屈嗪(hydralazine);或抗血栓试剂,诸如阿司匹林和肝磷脂;或其它治疗化合物、蛋白质(诸如贻贝粘合蛋白(MAP))、氨基酸(诸如3-(3,4-二羟基苯基)-L-丙氨酸(DOPA))、基因、或细胞材料,参见美国专利5,658,308、WO 99/65401、Kui Hwang等的Polymer Preprints2001,42(2),147Synthesis and Characterization of Self-Assembling BlockCopolymers Containing Adhesive Moieties以及WO 00/27445,上述文献公开的内容通过引用***本文。结合在水凝胶材料中的基团的实例包括,但不限于,羟基、胺和羧酸。
在另一实施方式中,可以通过掺入含有例如碘的单体和/或聚合物,或者可以通过掺入诸如钽和铂的不透射线金属来使可膨胀元件1变得不透射线。
在一些实施方式中,载体构件2具有柔软、细长的结构。适于载体构件2的构型包括,螺旋状线圈、编织物和开缝(slotted)或开螺旋(spiral-cut)管子。载体构件2可由任何适当的生物相容性金属或聚合物制成,所述生物相容性金属或聚合物诸如为铂、钨、PET、PEEK、Teflon、Nitinol、尼龙、钢等。所述载体构件可被形成二级构型,诸如螺旋、盒形、球形、平环、J-型、S-型或本领域已知的其它复杂形状。Horton5,766,219、Schaefer申请10/043,947和Wallace 6,860,893中公开了适当形状的实例,所有上述专利文献通过引用***本文。
如前所述,本发明的一些实施方式可以包括如下聚合物,这种聚合物足够柔软、柔韧,从而基本上连续长的可膨胀元件1将形成与初始设定在载体构件2中的构型类似的二级构型,而不需对器械进行预软化或者将其暴露于血液、液体或蒸汽。
在一些实施方式中,载体构件2具有至少一个间隙(gap)7,所述间隙的尺寸允许可膨胀元件1膨胀穿过该间隙(这个结构的一个实施方式在图1-2中示出)。在其它实施方式中,载体构件2包括至少一个间隙7,该间隙允许可膨胀元件1暴露至体液,但是可膨胀元件1不需膨胀穿过间隙(这个结构的一个实施方式在图8中示出)。在其它实施方式中,载体构件2基本上没有间隙。更确切地说,流体被允许渗透通过器械的末端或通过输送***的管腔被注射,从而可膨胀元件1膨胀并迫使其穿过载体构件2。
在图1所示的一个实施方式中,可膨胀元件1包括丙烯酰胺或以聚(乙二醇)为基体的可膨胀水凝胶。载体构件2包括线圈。载体构件2中形成至少一个间隙7。可膨胀元件1以基本共轴构型被设置在由载体构件2所限定的腔体3内。例如通过激光、焊料、粘合剂或熔融水凝胶材料本身,在器械11的远端处形成末端(tip)4。可膨胀元件1可以由近端连续延伸至远端,或者其可以延伸到器械的一部分,然后在到达远端或近端之前终止,或者其可以为二者。
作为实施例,在一个实施方式中,器械被形成治疗脑动脉瘤的尺寸。本领域技术人员将认识到,可以重新设定用在这个实施例中的尺寸,从而治疗更大或更小的损伤。在这个实施方式中,可膨胀元件1在膨胀前约为0.001”-0.030”,膨胀后约为0.002”-25”。可膨胀元件例如为约5%-30%的丙烯酸钠、10%-30%的分子量在400至30000g/mol范围内的聚(乙二醇)二丙烯酰胺、其余为水。本领域技术人员将认识到,可以通过改变丙烯酸钠、PEG二丙烯酰胺和水的相对量来控制膨胀比率。这个实施方式中的载体构件2是直径在约0.005”-0.035”范围内的微型线圈。在另一实施方式中,微型线圈的直径为0.008’-0.016’。微型线圈可以具有在0.0005”-0.01”范围内的细丝。在另一实施方式中,细丝范围为0.00075”-0.004”。植入体11包括至少一个间隙7,其在0.5个细丝(0.00025”)长至20个细丝(0.2”)长的范围内。在另一实施方式中,间隙范围介于约0.00025”至0.005”之间。在一个优选的实施方式中,微型线圈的直径为0.012”,具有0.002”的细丝,其中间隙7为0.0013”。连接器13被置于接近近端,从而允许植入体11以可拆卸方式偶合到输送***上,或推过或注射通过导管。在共同待审的Fitz的申请11/212,830、Guglielmi的US6,425,893、Ritchart的US4,994,069、Diaz的US6,063,100和Berenstein的US5,690,666中找到了输送***的实例,这些专利公开的内容通过引用***本文。
在这个实施方式中,植入体11通过如下构成:如前所述将水凝胶原料进行配制并混合,从而形成可膨胀元件1。将载体构件2缠绕成螺旋或复杂形式,然后通过本领域已知技术将其加热固定,从而形成在0.5mm至30mm的范围内的二级直径,在5mm至100cm的范围内的长度。在加工、洗涤、可选酸处理后,该可膨胀元件1穿过载体构件2的腔体3。然后,通过成结,将可膨胀元件1的远端系在载体构件2的远端上。可以使用粘合剂(例如可UV固化粘合剂或环氧粘合剂)进一步增强可膨胀元件1和载体构件2之间的结合并形成远末端4。或者,可以例如通过激光焊接或锡球(solder ball)形成末端。
在一些实施方式中,根据间隙7的尺寸和膨胀的比率,当可膨胀元件1膨胀时可以如图7所示形成弯曲或弯折12。尽管弯曲或弯折12不会对器械的功能造成影响,但是在一些实施方式中希望避免上述弯曲或弯折12的形成。这可以通过如下来实现:在可膨胀元件1置于载体构件2中以前或者在可膨胀元件1的远端被固定在载体构件2上以后将其进行拉伸。例如,一旦可膨胀元件1的远端被固定在载体构件2上,将可膨胀元件1拉伸至最终长度是其起始长度的101%至1000%(例如,如果起始长度为1”,那么可膨胀元件被拉伸至1.01”-10.0”),或者拉伸至足以防止在膨胀后的可膨胀元件1中形成弯曲的长度。例如,在先前所述脑动脉瘤治疗的实施方式中,可膨胀元件1被拉伸至最终长度约为起始长度的125%-600%。在另一实施方式中,可膨胀元件被拉伸至最终长度约为起始长度的125%-300%。在一个优选的实施方式中,可膨胀元件被拉伸至最终长度约为起始长度的267%。拉伸后,可以修剪可膨胀元件1以与载体构件2的长度匹配,然后例如通过打结、粘合剂接合或本领域已知的其它技术将其接合到载体构件2的近端。
一旦制成了植入体,就通过本领域已知方法将其连接到前面所述的输送***上。还可以将该器械暴露于例如电子束或γ辐射,以交联可膨胀元件1并控制其膨胀。这在美国专利6,537,569中进行了描述,该专利转让给该申请的受让人,并通过引用***本文。
以前,由于现有器械(例如HES)的相对挺度,其二级尺寸通常被制成尺寸比治疗点的尺寸(即体积)小1-2mm。本发明的植入体11的较高柔韧性和其总体设计允许植入体11的二级形状被形成为尺寸几乎等于治疗位点的尺寸或甚至稍微较大。这种尺寸设计进一步降低了植入体在治疗位点内移动或滑动出治疗位点的风险。
现有植入器械(诸如HES器械)目前为用户提供约5分钟的复位时间。然而,本发明的植入体11延长了复位时间的长度。在一些实施方式中,手术过程中的复位时间可以延长至约30分钟。在这种情况下,为用户提供了较长的定位时间,从而更好地达到所需植入体结构。
图2示出了与图1所示类似的植入体11,其中可膨胀元件1穿过间隙7膨胀至尺寸大于载体构件2。
图3示出了植入体11,其中,多个可膨胀元件1彼此几乎平行地延伸穿过载体构件2。在一个实施方式中,这个结构通过如下构成:使一个可膨胀元件1在植入体11的末端4成环,然后使可膨胀元件1的两个末端都系在载体构件2的近端上。在另一实施方式中,多股可膨胀元件1可以沿着载体构件2的长度结合。这些实施方式的结构还可以包括,如前所述拉伸可膨胀元件1以及/或者在载体构件2中形成间隙。
图4示出了这样一个实施方式,其中植入体11包括非线圈载体构件2。在一个实施方式中,载体构件2通过如下形成:采用例如刀片、激光或喷水器(water jet)对诸如聚酰亚胺、尼龙、聚酯、聚乙醇酸、聚乳酸、PEEK、Teflon、碳纤维或热解碳、硅酮或本领域已知的其它聚合物的塑料管或片进行切割,从而形成缝、孔或其它开口(fenestration),通过这些缝、孔或开口可膨胀元件1可以与体液接触。这个实施方式中的塑料还可以包括不透射线试剂,诸如钨粉末、碘或硫酸钡。在另一实施方式中,载体构件2通过如下形成:采用例如酸刻蚀、激光、喷水器或本领域已知的其它技术对诸如铂、钢、钨、Nitinol、钽、钛、铬-钴合金等的管或片进行切割。在另一实施方式中,载体构件2通过如下形成:编织、针织或包裹金属或塑料纤维,从而形成开口。
图5示出了植入体11,其包括载体构件2、可膨胀元件1和抗拉伸构件10。抗拉伸构件10用于保护载体构件2在输送和复位过程中免于伸展或展开。抗拉伸构件10可由各种金属或塑料纤维制成,例如由钢、Nitinol、PET、PEEK、Nylon、Teflon、聚乙烯、聚烯烃、聚烯烃弹性体、聚丙烯、聚乳酸、聚乙醇酸和各种其它本领域已知的缝合材料。植入体11的结构可以通过如下形成:如Ken的US6,013,084和Marks的US5,217,484所述,将抗拉伸构件10的末端连接到载体构件2的末端,上述两篇专利通过引用***本文。或者,如Fitz的共同待审申请11/212,830中所述,抗拉伸构件10的远端可以连接载体构件2的远端附近,而抗拉伸构件10的近端连接到输送***上。
图6是另一个实施方式,其抗拉伸构件10围绕膨胀元件1进行包裹、打结或与膨胀元件1缠绕。这可以在可膨胀元件1的整个长度上出现,或者可以仅在一个区域内进行包裹或打结,从而便于通过使用抗拉伸构件10作为结合元件将可膨胀元件1结合到载体元件2上。
图7示出了突出到载体元件2外部的可膨胀元件1的弯曲或弯折12。在一些实施方式中,可以例如通过如前所述拉伸可膨胀元件1来避免这种情况。这将在如下实施方式中进行,例如被配置成通过小微型导管输送从而避免植入体11在输送过程中粘在微型导管中的实施方式。在另一实施方式中,可使可膨胀元件1松弛,从而在植入体11中预形成弯曲或弯折。这可以在如下实施方式中进行,在所述实施方式中,例如需要大量体积填充物,因为弯曲和折层往往导致可膨胀元件1的总长度增加。
图8示出了一个实施方式,其中可膨胀元件1被配置成膨胀至尺寸大于其原始尺寸,但小于载体构件2的外部尺寸。这可以通过如下来实现:调整其中可膨胀元件1包括水凝胶的实施方式中例如PEO二丙烯酰胺与丙烯酸钠的比率。或者可以使用相对高剂量的辐射,以使可膨胀元件1交联,从而限制其膨胀。当需要小体积填充物并且需要可膨胀元件1提供组织生长和分化用底物时,图8中所示的实施方式是理想的。在用于治疗脑动脉瘤的实施方式中,这个结构被用作最终或“完工”线圈,或者用在尺寸用于治疗小动脉瘤(直径在10mm以下)的器械中,或者被用作第一“框架”或定位的3-D线圈。在一个实施方式中,可膨胀元件1包括如前所述掺有成孔剂的水凝胶,从而得到网状基质以利于细胞生长和愈合。如前所述,例如在可膨胀元件1中掺入生长激素或蛋白质可以进一步增强植入体11引发生物响应的能力。
在本发明的一个实施方式中,血管阻塞器械包括:具有外表面的可膨胀聚合物元件;载体构件,其覆盖所述可膨胀聚合物元件外表面的至少一部分,其中没有载体被置于所述可膨胀元件的外表面内。
在另一实施方式中,血管阻塞器械包括具有腔体的线圈和具有外表面的水凝胶聚合物,其中,所述水凝胶聚合物被放置于所述线圈的所述腔体内,并且所述水凝胶聚合物不包含在所述水凝胶聚合物的外表面内的线圈。
在另一实施方式中,血管阻塞器械包括:被形成为二级构型的载体构件;和可膨胀元件,其中,所述可膨胀元件由被配制成足够柔软的聚合物制成,从而所述可膨胀元件基本上呈现在所述载体构件内形成的所述二级构型的形状,而无需预处理。
在另一实施方式中,血管阻塞器械包括:被形成为二级构型的载体构件;和基本连续长的水凝胶,其中,所述器械基本上呈现在所述载体构件内形成的所述二级构型的形状,而无需预处理。
在另一实施方式中,血管阻塞器械包括具有内腔的微型线圈和被设置在所述内腔中的可膨胀元件。在这个实施方式中,可膨胀元件包括选自丙烯酰胺、聚(乙二醇)、普流尼克(Pluronic)和聚(氧化丙烯)的水凝胶。
在另一实施方式中,血管阻塞器械包括线圈和至少部分被设置在所述线圈中的水凝胶聚合物,其中,所述水凝胶具有初始长度,并且所述水凝胶聚合物已被拉伸至比所述初始长度更长的第二长度。
在另一实施方式中,血管阻塞器械包括可膨胀元件和限定内腔的载体构件,其中,所述可膨胀元件被设置在所述载体构件的所述内腔中,并且所述可膨胀元件已被拉伸至足够长,从而防止可膨胀元件的弯曲突出穿过所述载体构件。
本文公开的发明还包括一种制造医疗器械的方法。所述方法包括:提供具有内腔的载体构件和可膨胀元件,将所述可膨胀元件***所述载体构件的所述内腔中,并拉伸所述可膨胀元件。
在另一实施方式中,血管阻塞器械包括被载体元件封装的可膨胀元件,其中,所述可膨胀元件基本上全部且基本上均匀地由具有膨胀性质的材料组成。
在另一实施方式中,血管阻塞器械包括载体元件和可膨胀元件,其中,所述载体元件具有与其一级形状不同的二级形状,并且所述可膨胀元件在常规未经处理的状态下足够柔软,从而顺应所述载体的二级形状。
在另一实施方式中,血管阻塞器械包括载体和可膨胀元件,其中,所述可膨胀元件以沿着所述载体被拉伸的方式固定在所述载体上。
在另一实施方式中,血管阻塞器械包括:载体,其具有多个沿着所述载体的间隙;和可膨胀元件,其沿着所述载体的内部封套定位,其中对所述可膨胀元件的膨胀进行控制,从而所述可膨胀元件膨胀进入间隙,但是未越过所述载体的外部封套。
在另一实施方式中,血管阻塞器械包括载体构件和可膨胀元件,其中,所述可膨胀元件由沿着所述载体伸展的多股组成。
在另一实施方式中,血管阻塞器械包括载体和可膨胀构件,其中,所述载体具有非线圈圆柱形状的结构,并且所述可膨胀构件被设置于所述载体内部。
在另一实施方式中,血管阻塞器械包括载体、可膨胀构件和抗拉伸构件,所述可膨胀构件和所述抗拉伸构件被设置在所述载体的内部区域中,并且在所述载体上的所述抗拉伸构件处于拉紧状态。
本文所公开的发明还包括一种治疗体内损伤的方法。所述方法包括,提供一种含有载体构件和可膨胀元件的血管阻塞器械,其中,所述载体构件被形成为具有与所述损伤几乎相同直径的二级构型,并且将所述血管阻塞器械***所述损伤。
尽管本说明书和附图中已经描述了本发明的优选实施方式,但是应当理解到,相关领域的技术人员可以进行各种变化和修正。因此,本发明的范围并不局限于本文所述的特定实施方式和实施例,而应当认为涵盖了可供选择的实施方式和等同物。
除非另有指明,本说明书和权利要求书中使用的表示成分数量,以及分子量、反应条件等性质等的所有数字都应当被理解为:在所有情况下,用术语“大约”加以修饰。因此,除非有相反含义的说明,本说明书和所附权利要求书中示出的数量参数都是约数,它们可以根据本发明想要获得的性质而变动。至少,并且并非对权利要求书范围等同原则的应用加以限制,每个数量参数至少应按照报道的有效数字的数,以及应用普通的凑整技术来解释。虽然示出本发明宽广范围的数字范围和参数是约数,但是具体实施例中所示的数值却被尽可能地精确报道。但是,任何数值,必然含有一定误差,这是它们各自的检验测量方法中发现的标准偏差必然导致的。
除非本文另有指明,或与上下文明显矛盾,描述本发明的上下文(尤其在权利要求书的上下文)中使用的术语“一个”、“一种”和“这个”以及类似提法应当被理解为既包括单数又包括复数。本文中数值范围的叙述仅仅用作该范围内每个单独的值的速记方法。除非本文另有指明,每个单独的值被包括进说明书,这与在本文进行个别叙述一样。本文所述的所有方法都可以以任何合适的顺序来进行,除非本文另有指明,或与上下文明显矛盾。除非另有指明,本文提供的任何及所有例子,或者示例性的语言(例如,“诸如”)仅用来更好地阐述本发明,而非对发明范围加以限制。说明书中任何语句都不应被解释为:表示对本发明的实施来说必要的、不要求保护的要素。
本文公开的本发明的替换性要素或实施方式的分组不应被理解为限制。每个组成员可被个别采用和被个别要求保护,或以与该组其它成员或本文中找到的其它要素的任何组合被采用和要求保护。可以预见到,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一组或从中删除。当任何此类包括或删除发生时,说明书在此被看作为含有经过改动的组,因此满足对所附权利要求书中所用的全部马库什组的支持。
本文中描述了本发明的某些实施方式,其包括发明人已知用来实施本发明的最佳方式。当然,在阅读前述说明书的基础上,对这些优选实施方式的改动对于本领域普通技术人员来说将是明显的。本发明的发明人预见了本领域技术人员合适地采用此类改动,发明人预期本发明可以以除了本文具体描述的方式之外的方式被实现。因此,只要适用法律允许,本发明包括对所附权利要求中提到的主题进行的所有改动和等同物。此外,所有可能的变化中,上面提到的要素的任何组合都被包括进本发明,除非本文另有指明,或与上下文明显矛盾。
此外,本说明书中提到了大量参考文献,包括专利和印刷公开物。上述参考文献和印刷公开物中的每种在此都通过引用被分别包括进本文。
最后,应当理解,本文公开的本发明实施方式是为了阐述本发明的原理。可以进行的其它改动也落在本发明的范围内。因此,举例而言,而非限制,可按照本文的教导来使用本发明的替代性结构。因此,本发明不被限制为仅仅是本文所述和所示出的。
Claims (37)
1.一种阻塞动物中的腔的器械,所述器械包括:
可膨胀元件,所述元件包含在生理学条件下经历可控体积膨胀的水凝胶,其中,所述生理学条件是生理学pH,并且其中所述水凝胶包含:
具有可离子化官能团和烯属不饱和片段的可离子化单体,其中所述可离子化单体的10%-50%的是pH敏感性的;
非离子大单体,选自由聚(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;和
聚合引发剂;并且
所述水凝胶具有0.1mg至50mg的未膨胀抗弯强度;以及
包括由金属、塑料或类似材料制成的线圈或微型线圈的载体构件,其中所述载体构件包含多个沿着所述载体构件的间隙,所述间隙允许所述可膨胀元件膨胀至尺寸大于所述载体构件的直径或者膨胀至尺寸等于或小于所述载体构件的直径,并且其中所述可膨胀元件沿着所述载体构件的内部封套定位。
2.如权利要求1所述的器械,其中,所述非离子大单体具有400g/mol至35000g/mol的分子量。
3.如权利要求1所述的器械,其中,所述可离子化官能团包括碱性基团。
4.如权利要求3所述的器械,其中,所述碱性基团包括胺、其衍生物或其组合。
5.如权利要求4所述的器械,其中,所述碱性官能团可以在高于所述官能团的pKa的pH下去质子化,或者在低于所述官能团的pKa的pH下质子化。
6.如权利要求1所述的器械,其中,所述可离子化官能团包括酸性基团。
7.如权利要求6所述的器械,其中,所述酸性基团包括羧酸、其衍生物或其组合。
8.如权利要求7所述的器械,其中,所述酸性官能团可以在低于所述官能团的pKa的pH下质子化,或者在高于所述官能团的pKa的pH下去质子化。
9.如权利要求1所述的器械,其中,所述可离子化单体具有乙烯基基团、丙烯酸酯基团、丙烯酰胺基团、甲基丙烯酸酯基团、其衍生物或其组合。
10.如权利要求1所述的器械,其中,所述非离子大单体包括聚(乙二醇)二丙烯酰胺。
11.如权利要求1所述的器械,其中,所述水凝胶基本上不含丙烯酰胺。
12.如权利要求1所述的器械,其中,所述非离子大单体采用至少一种烯属不饱和化合物进行交联。
13.如权利要求1所述的器械,其中,所述非离子大单体采用N,N’-亚甲基二丙烯酰胺、其衍生物或其组合进行交联。
14.如权利要求1所述的器械,其中,所述水凝胶利用选自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’-偶氮二(2-甲基丙酰脒)二盐酸盐、其衍生物或其组合的聚合引发剂来聚合。
15.如权利要求1所述的器械,其中,所述水凝胶基本上不可再吸收。
16.一种用于制备阻塞动物中的腔的器械的方法,所述方法包括:
a)至少将非离子大单体、具有可离子化官能团和烯属不饱和片段的单体、至少一种聚合引发剂和至少一种溶剂进行组合,从而制备水凝胶,所述非离子大单体选自聚(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;
b)对所述水凝胶进行处理,从而制备在生理学条件下具有响应性的环境响应性的水凝胶,
c)将基本上连续长的水凝胶置于所述载体构件的腔体中,所述载体构件包括由金属、塑料或类似材料制成的线圈或微型线圈,并且其中所述载体构件包含多个沿着所述载体构件的间隙,所述间隙允许所述可膨胀元件膨胀至尺寸大于所述载体构件的直径或者膨胀至尺寸等于或小于所述载体构件的直径,并且其中所述可膨胀元件沿着所述载体构件的内部封套定位。
17.如权利要求16所述的方法,其中,所述至少一种可离子化官能团包括酸性基团。
18.如权利要求17所述的方法,其中,所述处理包括,将所述水凝胶在酸性环境中进行培养,从而使所述酸性基团质子化。
19.如权利要求17所述的方法,其中,所述酸性基团包括羧酸、其衍生物或其组合。
20.如权利要求16所述的方法,其中,所述至少一种可离子化官能团包括碱性基团。
21.如权利要求20所述的方法,其中,所述处理包括,将所述水凝胶在碱性环境中进行培养,从而使所述碱性基团去质子化。
22.如权利要求21所述的方法,其中,所述碱性基团包括胺、其衍生物或其组合。
23.如权利要求16所述的方法,其中,所述溶剂包括水、乙醇或其组合。
24.如权利要求23所述的方法,其中,所述溶剂包括水。
25.如权利要求16所述的方法,其中,所述非离子大单体的浓度为5重量%至40重量%。
26.如权利要求16所述的方法,其中,所述溶剂的浓度为20重量%至80重量%。
27.如权利要求16所述的方法,其中,所述组合进一步包括,添加至少一种交联剂,所述交联剂包括具有多个烯属不饱和基团的化合物。
28.如权利要求16所述的方法,其中,所述聚合引发剂包括氧化-还原聚合引发剂。
29.如权利要求16所述的方法,其中,所述聚合引发剂包括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’-偶氮二(2-甲基丙酰脒)二盐酸盐、其衍生物或其组合。
30.如权利要求16所述的方法,其中,所述组合进一步包括,添加成孔剂。
31.如权利要求18所述的方法,其中,所述酸性基团在植入动物中后能够去质子化。
32.如权利要求21所述的方法,其中,所述碱性基团在植入动物中后能够质子化。
33.如权利要求16所述的方法,其中,所述至少一种聚合引发剂包括过硫酸铵和N,N,N’,N’-四甲基乙二胺,所述溶剂包括水。
34.如权利要求16所述的方法,其中,所述非离子大单体具有400g/mol至35000g/mol的分子量。
35.如权利要求16所述的方法,其中,所述具有环境响应性的水凝胶基本上不可再吸收。
36.如权利要求16所述的方法,其中,所述具有环境响应性的水凝胶基本上不含丙烯酰胺。
37.如权利要求16所述的方法,其中,所述具有环境响应性的水凝胶具有0.1mg至85mg的未膨胀抗弯强度。
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