CN100401991C - 动脉瘤治疗装置 - Google Patents
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Abstract
本发明涉及一种用于治疗血管动脉瘤的装置,其可经导管输送到血管动脉瘤的位置。该治疗装置总体包括:由至少一个支承件形成的主体件和选择性地施加到至少一个支承件上的活性材料。该主体件向脆弱的或无机能的血管提供机械支承。在大致不影响流经血管的血流的情况下,该活性材料可限制或阻塞流向动脉瘤的血流。
Description
通常,哺乳动物的循环系统包括作为泵的心脏和将血液输送到身体各处的血管系统。由于通过流动的血液施加在血管上的力,所以血管可能发生各种血管能力丧失和机能失调。动脉瘤是一种常见的血管机能失调,其导致血管异常的变宽。通常,血管动脉瘤是由于血管的壁变薄并且血管随后胀大而形成。如图1所示,动脉瘤10通常包括与血管14连通的窄颈部12和与窄颈部12连通的圆顶部16。如图1所示,窄颈部12和圆顶部16形成腔18。已知的动脉瘤可以在包括脑、腹部、和遍及循环系统的全身的多个位置处形成。
因此,已经开发处多种用于治疗动脉瘤的手术技术。起初,需要动脉瘤切除术来修补机能失调的组织。动脉瘤切除术过程需要医生可触及到动脉瘤、切除动脉瘤、并使用修复移植来代替空隙。因为这是一种主要由手术完成的工作,所以该处理过程的死亡率较高。通常,动脉瘤切除术过程对于患有严重的冠状动脉和脑动脉硬化、严重的肺病、和明显的肾病或其它并发症因数的患者来说是不能使用的。
称为“显微手术夹持”的治疗脑动脉瘤的替代方法需要在动脉瘤的颈部上设置金属夹,由此阻断动脉瘤的血液流动。
由于动脉瘤切除术和显微外科夹持过程的缺点,已经开发出侵入程度较底的方法。通常,这些过程需要形成人为血管阻塞,这是通过将多个器件或适当的材料植入到动脉瘤的腔18中从而导致流入动脉瘤的血流减少而实现的。血流的减少导致血液停滞并形成凝块。通常,该过程需要医生将微导管推入到动脉瘤内的位置并且在其中施加在生物上相容的血管阻塞材料或器件。常用的血管阻塞器件和材料包括铂细微线圈、猪鬃、细微纤维胶原、各种聚合物试剂、材料悬浮液、和其它空间填充材料。图2示出了形成在血管14上的动脉瘤10,该动脉瘤10具有位于动脉瘤圆顶部18中的血管阻塞器件20。使用该器件填充动脉瘤的缺点在于,血管阻塞块可能碰到神经或其它生物组织结构,由此导致不利的生物症状。例如,血管阻塞器件20碰到在脑内的神经或结构会导致不利的神经症状,通常称为“质量作用效应”。与血管阻塞器件相关的另一问题在于,在动脉瘤中保持该器件。如果该器件在植入过程中或之后偏移,则经过其它机能血管的血流可能中断,因此可能导致血栓。
已经开发出的修复动脉瘤的替代方法需要在动脉瘤的颈部附近的血管中植入机械支承器件。通常,称为“血管支架”的这些机械支承器件包括通过导管在血管中输送就位的可展开式的机械支承结构。除了对机能失调的血管壁提供机械支承之外,该血管支架可包括用于限制血液流经动脉瘤附近的血管的机械机构,由此减小或消除动脉瘤。可限制流向动脉瘤的血流的示例性机械结构包括定位在动脉瘤10附近并限制流向其的血流的网或网状结构。图3示出了在动脉瘤10附近定位在血管14中的血管支架22。尽管血管支架对血管提供了足够的支承,但是这些器件在限制流向动脉瘤的血流方面有效性有限。因而,动脉瘤通常保持未受影响并可能增大。因此,血管支架可覆盖有设计用于限制流向动脉瘤的血流的涂层。这些涂层通常包括生物性相容的聚合物、薄膜、和织物。然而,将这些涂层施加到血管支架上会增大该器件的截面直径,由此导致较大型面的血管支架移植件。因此,经过血管的血流由于存在较大型面的血管支架移植件而减少。此外,器件型面对于脑动脉瘤的治疗是显著的问题,这是因为脑血管的尺寸较小,所以需要该器件可通过微导管输送到动脉瘤。因而,较大型面的血管支架移植件通常不用于治疗脑动脉瘤。
因此,现今存在着对于有效治疗动脉瘤而且不显著影响流经血管的血流的器件和方法。
发明内容
本发明解决了上述的问题,其中在大致不削弱流经血管的血流的情况下,本发明的动脉瘤治疗装置有效地阻塞或抑制流向动脉瘤的血流。此外,本发明的动脉瘤治疗装置可应用于全身各处的形成在血管上的各种动脉瘤。本领域的普通技术人员应当理解,本发明可容易地制造并可由多种材料制成。
本发明的动脉瘤治疗装置包括:具有至少一个表面的至少一个支承件;和选择性地施加到所述支承件上的活性材料。该至少一个支承件至少具有可接受活性材料的第一表面,该支承件向接受的活性材料提供了基质。或者,该至少一个支承件还可向脆弱的血管组织提供支承。该活性材料具有未起作用的状态和起作用后的状态。在起作用后的状态中,该活性材料选择性地施加到至少一个支承件上,该活性材料可限制或阻塞流向动脉瘤的血流。在替代实施例中,该至少一个支承件可由活性材料制成或以其它方式结合到其中。该器件优选地可从细长的输送装置上可控制地松释。该松释机构可以是现有技术已知的任何的血管阻塞器件和血管支架拆卸装置,其包括但不限于机械式、电解式、电动机械式、热力式、液压式、和形状记忆式松释机构。
在替代实施例中,本发明涉及血管修补器件,其具有径向和轴向柔性的修补主体件,该修补主体件由多个互锁的支承件形成。可支承血管的互锁的支承件形成多个网格。可限制或阻塞流向动脉瘤的血流的活性材料选择性地施加、编织到、整体形成到、或以其它方式结合到互锁的支承件中。例如,该互锁支承件可由纤维状或成形的活性材料制成。
在又一实施例中,本发明涉及具有盘绕桥接器件,其具有径向和轴向柔性的弹性的正弦曲线形的主体件,该正弦曲线形的主体件限定出多个开口。正弦曲线形的主体件具有第一曲率半径R和第二曲率半径R’,其中R’大于R。正弦曲线形的主体件由至少一个支承件形成并具有选择性地施加到其上的可限制或阻塞流向动脉瘤的血流的活性材料。
在另一实施例中,本发明涉及具有径向和轴向柔性的柱形主体件的螺旋形血管支架,该柱形主体件位于第一端和第二端之间,由可支承血管组织的至少一个支承件形成的该柱形主体件还限定出与所述第一和第二端连通的内腔。可限制或阻塞流向动脉瘤的血流的活性材料选择性施加到至少一个支承件上。
在再一实施例中,本发明涉及具有径向和轴向柔性的柱形主体件的螺旋形血管支架,该柱形主体件位于第一端和第二端之间,由可支承血管组织的至少一个支承件形成的该柱形主体件还限定出与所述第一和第二端连通的内腔。可限制或阻塞流向动脉瘤的血流的活性材料选择性施加到至少一个支承件上。
在另一实施例中,本发明涉及具有径向和轴向柱形主体件的网状膨胀的血管支架,该柱形主体件位于第一端和第二端之间,由可支承血管组织的至少一个支承件形成的柱形主体件限定出与所述第一和第二端连通的内腔。可限制或阻塞流向动脉瘤的血流的活性材料选择性施加到至少一个支承件上。
在又一实施例中,本发明涉及具有径向和轴向柔性的分叉主体件的分叉血管支承器件,该柱形主体件位于第一端、第二端、和第三端之间。该分叉主体件还限定与第一、第二和第三端连通的内腔。该分叉主体件由可支承血管组织组织的至少一个支承件形成。可限制或阻塞流向动脉瘤的血流的活性材料选择性施加到至少一个支承件上。
在另一实施例,本发明涉及可输送到动脉瘤中的在动脉瘤内的桥接器件,该器件包括与柔性的桥接主体件连通的至少两个接合件。至少两个接合件共同地形成连接部。可限制或阻塞流向动脉瘤的血流的活性材料选择性施加到至少两个接合件上。
本发明还披露了一种治疗血管动脉瘤的方法。具体地说,治疗动脉瘤的新方法包括以下步骤:提供具有选择性地施加到其上的活性材料的器件;将该器件输送到血管动脉瘤处;使用该器件支承在动脉瘤附近的组织;使该活性材料活化起作用,以便允许血液流经血管并同时限制或阻塞流向动脉瘤的血流。
参照附图并结合以下的详细描述,本发明的其它目的和特征更加清晰。
附图说明
在附图中:
图1是其壁上形成有血管动脉瘤的血管的截面图;
图2是现有技术的治疗血管动脉瘤的方法的截面图,该方法需要在血管动脉瘤内设置材料;
图3是现有技术的治疗血管动脉瘤的方法的截面图,其中机械式血管支架定位在动脉瘤附近;
图4是本发明的支承件的截面图,该支承件具有设置在其上的未起作用的活性材料;
图5a是本发明的支承件的截面图,该支承件具有设置在其上的起作用后的活性材料;
图5b是本发明的支承件的截面图,其具有包括在其中交织的活性材料的结构;
图6是本发明的实施例的立体图,其包括用于限制流向血管动脉瘤的血流的血管修补器件;
图7是本发明的另一实施例的立体图,其包括用于限制流向血管动脉瘤的血流的血管修补器件;
图8是本发明的血管修补器件的立体图,其定位在血管动脉瘤附近的血管内;
图9是本发明的血管修补器件的截面图,其定位在血管动脉瘤附近的血管内;
图10是本发明的实施例的立体图,其包括用于限制流向血管动脉瘤的血流的盘绕桥接器件;
图11是本发明的另一实施例的立体图,其包括用于限制流向血管动脉瘤的血流的盘绕桥接器件;
图12是本发明的盘绕桥接器件的截面图,其用于限制流向血管动脉瘤的血流;
图13是本发明的实施例的立体图,其包括用于限制流向血管动脉瘤的血流的螺旋形血管支架器件;
图14是用于限制流向血管动脉瘤的血流的螺旋形血管支架器件的另一实施例的立体图;
图15是本发明的螺旋形血管支架器件的截面图,该器件定位在血管动脉瘤附近的血管中;
图16是包括用于限制流向血管动脉瘤的血流的网状血管支架器件的立体图;
图17是用于限制流向血管动脉瘤的血流的网状血管支架器件的另一实施例的立体图;
图18是定位在血管动脉瘤附近的血管中的本发明的网状血管支架器件的截面图;
图19是本发明的实施例的截面图,其包括定位在在血管动脉瘤附近的血管中的网状分叉器件;
图20是用于限制流向血管动脉瘤的血流的在动脉瘤内的桥接器件的另一实施例的截面图;
图21是定位在血管动脉瘤附近的血管中的本发明的在动脉瘤内的桥接器件的截面图;和
图22是本发明的实施例的立体图,其定位在血管内的可膨胀的囊体微细导管。
具体实施方式
在此披露了本发明的各个实施例的详细描述。本说明书不是限定性,而仅仅是为了对本发明的基本原理进行说明。本说明书的小标题和整体结构仅仅是为了方便说明,而不是限定本发明。
本发明的动脉瘤封闭装置通常限制流经血管的血液进入形成于其上的动脉瘤的能力。在此披露的该器件可以通过多种方式施加到血管上,其中包括(但不限于)常规的手术技术和使用多种尺寸的导管、气囊导管、细微导管的最小程度的侵入式手术技术以及现有技术已知的最小程度的侵入式手术。尽管本发明可用于在全身的各个位置处修复动脉瘤,但是本发明特别有利于修复或治疗脑血管的动脉瘤的过程。本发明的器件和方法与在3/13/01提交的共同未决的美国专利序列号09/804935“Hydrogels and their undergo volumetricexpansion in response to changes in their environment andtheir methods of manufacture and use”中披露的材料和制造方法和用途特别兼容,该专利转让给本发明的受让人并且通过引证将其全部内容引入本发明。本领域的普通技术人员应当理解,本发明可使用多种施加到其上的替换的活性材料,其包括例如现有技术已知的胶原聚合物共轭材料、可光致聚合的生物降解材料、和其它可生物降解的交联的水凝胶。
动脉瘤是这样形成的,即由于向外压力通过在血管内的血流作用于病变或损伤的血管壁上,由此导致组织的脆弱部分从血管壁向外胀大。图1示出了动脉瘤10,其包括与血管14连通的颈部12并具有限定动脉瘤腔18的圆顶部分16。本领域的普通技术人员应当理解,图1示出了血管动脉瘤的一个示例,并不限制本发明的范围或内容。
治疗动脉瘤的一个方法需要在动脉瘤附近或在动脉瘤内形成血栓,由此限制血流或剥夺动脉瘤的血流并减小动脉瘤破裂的可能性。图2和3示出了现有技术的通过人为地在动脉瘤内或在动脉瘤附近形成血栓以便修复动脉瘤的器件。在图2和3,附图标记10、12、14、16、18与图1中的附图标记表示相似的部分。图2示出了与血管14连通的动脉瘤10。如图所示,血管阻塞器件20定位在动脉瘤腔18内。通常,细微导管或其它装置用于将血管阻塞器件20注射或以其它方式插入到动脉瘤腔18中,由此减小可从血管14接收血液的动脉瘤容积。图3示出了用于治疗动脉瘤的替换器件。如图3所示,血管支架22定位在动脉瘤10附近的血管14中。血管支架22是用于向其它的机能不全的或脆弱组织提供支承或者保持窄或阻塞血管的显状的机械支架。
本发明披露了用于使得动脉瘤栓塞或隔离的多个器件。具体地说,本发明披露了可在多种血管的各个位置处植入的各种结构。在此披露了各种颈部桥接件(neck bridge)、血管修补件、和血管支架,它们通常由一系列的互锁的以其它方式连接的支承件以便形成预定的形状。图4和5a示出了用于本发明的多个实施例的在植入之前和之后的支承件24的一部分的截面图。如图4所示,支承件24可包括器件基质26,其具有在植入之前施加到其外部上的活性涂层或材料28。图5a示出了处于起作用后状态的设置在支承件24上的活性涂层28,其中活性涂层28已经从器件基质26上向外膨胀。本领域的普通技术人员应当理解,本发明的支承件24可由生物性相容的多种材料制成,其包括例如铂、金、钽、钛、不锈钢、钨、镍钛金属互化物、形状记忆合金、成形的活性材料、或其它适当的材料。图5b示出了本发明替换实施例,其包括与支承件24交织的活性材料线股28,由此形成交织结构27。本领域的普通技术人员应当理解,活性线股28可沿径向、轴向、和径向和轴向定向地定位在交织结构27内。在替代实施例中,本发明的器件基质26可由多种生物性相容的聚合物材料制成,其包括但不限于聚氨酯、聚乙烯醇、聚酯、聚四氟乙烯、硅酮、丙烯酸、或相似的聚合物材料。在另一替代实施例中,支承件24可结合不可透过无线电的或产生回波的材料或试剂,由此使得医生可在血管或其它中空器官内精确地定位该器件。本领域的普通技术人员应当理解,支承件24、器件基质26、和/或活性涂层28可以以化学方式掺杂有或充有药物或促进生长的材料,以便刺激组织生长或传递其它有利于支承件24的治疗剂。
该活性涂层或材料28可由多种随时间在血液或其它流体存在的情况下膨胀或容积改变的材料制成。在优选实施例中,本申请的申请人的在3/13/01提交的共同未决的美国专利序列号09/804935“Hydrogels and their undergo volumetric expansion inresponse to changes in their environment and their methods ofmanufacture and use”中披露了特别用作活性涂层或材料28的水凝胶,以便治疗动脉瘤。以上引证的水凝胶包括加入到琥珀瓶中的1.25g(0.021摩尔)的丙烯酰胺、0.87g(0.009摩尔)的丙烯酸钠、0.005g(0.00003摩尔)的N,N-乙烯双丙烯酰胺、7.95g的水、和4.5g的氯化钠(<10微米颗粒尺寸)。引发剂是53微升的N,N,N’,N-四乙基乙烯二元胺和在水中的65微升的20%重量/重量的过硫酸铵,引发剂加入,并且该溶液吸入到3-cc的注射器中。该溶液随后注射到内径0.025英寸的管中并使其聚合化2小时。该管被切成2英寸的部段并在真空炉中干燥。该干燥后的水凝胶在蒸馏水中洗三次,分别为10-12小时、2小时、和2小时,以便除去多孔物质、任何未起作用的单体、和任何未结合的单体。水凝胶随后被切成大约0.100英寸长的部段,其称为“丸剂”,并使用铂线圈/线材组件串起来。或者,水凝胶可拉制或形成为与支承件24具有相似尺寸和大小的纤维线股或部分。这些丸剂或线股随后在乙醇中水合并且在真空中在大约55C下干燥大约2小时。
其后,干燥的丸剂或线股随后置于50%的盐酸/50%的水中并在37C下培养大约70小时。在培养之后,多余的盐酸溶液通过连续冲洗从丸剂或线股上冲洗掉,冲洗是a)70%的异丙醇:30%的水冲洗大约5分钟,b)100%的异丙醇冲洗大约15分钟,c)100%的异丙醇冲洗大约15分钟,d)100%的异丙醇冲洗大约15分钟。该水凝胶丸剂或线股随后在55C下在真空中干燥至少2小时。在完全干燥过程之前或之后,丸剂或线股可通过所需的多种方式选择性地施加到至少一个支承件24上。如果需要,水凝胶线股可用作支承件24,并不需要加强。其后,水凝胶可通过多种方式选择性地施加到支承件上。在一个实施例中,活性材料施加到支承件24的整个表面上。在替代实施例中活性材料选择性地施加到支承件24的一部分上。例如,活性材料可选择性地施加到与血管壁接合的支承件24的一部分上。一旦本实施例的水凝胶植入到体内,处于生理pH(约7.4)大约一个小时之后其可完全膨胀(到直径大约0.035英寸)。或者,水凝胶线股可编织、或结合到支承结构中。此外,该支承结构可由水凝胶材料制成。
图6-9示出了本发明的用于使得动脉瘤与血管隔离的实施例。如图6所示,本实施例披露了包括主体件32的血管修补器件30,主体件32由彼此轴向地设置的多个交织或以其它方式连接的支承件24形成,其可支承脆弱的血管组织。该交织的支承件24形成多个网格34。如图6-8所示,活性涂层35选择性地施加到交织支承件24上。本领域的普通技术人员应当理解,本发明的实施例在没有大致阻塞流经该血管的血流的情况下使得形成在血管上的动脉瘤隔离并形成血栓。如图7所示,由多个支承件24形成的血管修补器件30具有弧形型面36。该弧形型面36可选择成近似接受血管的曲率半径,由此进一步地限制在植入之后的血管阻塞。本领域的普通技术人员应当理解,本发明的血管修补器件30可制造成多种尺寸。例如,血管修补器件30可接近接受血管的270度,由此使用机械力将该器件固定在血管内。如果需要,血管修补器件30可结合有可变形的支承件24,由此使得医生可调节弧形型面36,以便在植入过程中使其符合接受血管的曲率半径。在图8中,附图标记10、12、14、16、18与图1的附图标记表示相似的部分。图8示出了定位血管14中靠近动脉瘤10的血管修补器件30,其中该器件30横跨由颈部12形成动脉瘤腔18的开口38。如图8所示,活性涂层35的膨胀使得由血管修补器件30形成的多个网格34的尺寸减小,由此减少了进入动脉瘤的血液量。在替代实施例中,血管修补器件30可包括多个(未示出的)装接器件,以便有助于在血管内植入和固定该器件。该装接器件可包括例如由多种材料制成的钩、倒钩、或相似器件,这些材料例如为铂、金、钽、钛、不锈钢、钨、镍钛金属互化物、或其它适当的材料。在替代实施例中,血管修补器件30可结合替代的装接机构,其包括但不限于粘接剂材料、机械装接机构或真空装接机构。图9示出了定位在动脉瘤附近的本发明的血管修补器件30和血管14的截面图。本领域的普通技术人员应当理解,本发明的实施例可制成多种尺寸,由此使得其可用于各种血管以修补各个动脉瘤。
图10-12示出了用于治疗动脉瘤的本发明的替代实施例。如图10所示,本实施例披露了弹性的盘绕桥接器件40,其包括限定多个开口44的正弦曲线形主体件42。该主体件42沿弧46形成,由此有助于植入该器件并同时限制血管的阻塞。弹性的主体件42可沿线48压缩,以便在体内输送和定位该盘绕桥接器件40。当设置该盘绕桥接器件40时,主体件42的弹性沿线50施加向外的压力,其中弹性主体件42与(未示出的)血管壁接合。在替代实施例中,盘绕桥接器件40可用于向脆弱的血管组织提供机械支承。如图10所示,主体件42涂敷有或以其它方式设置有活性涂层,由此阻塞或以其它方式抑制流向动脉瘤的血流。图11示出了盘绕桥接器件40的替代实施例,其包括弹性的正弦曲线形的主体件42,该主体件具有至少一个设置在其上的活性部段52并限定多个开口44。活性部分52是如上所述的选择性地涂敷有或其它方式结合有活性材料的区域。本领域的普通技术人员应当理解,本实施例使得动脉瘤形成血栓并同时限制在血管内的阻塞。图12示出了定位在血管14内的本实施例的截面图,其中至少一个活性部段52阻塞或抑制流向动脉瘤10的血流。
图13-15示出了用于治疗形成在脆弱血管组织上的动脉瘤的本发明的另一实施例。图13-15示出了各种可膨胀的可使形成在脆弱血管组织上的动脉瘤形成血栓或隔离的“血管支架”。在替代实施例中,本发明的内腔脉管式的修复器件可用于向脆弱的血管组织提供机械支承。如图13所示,螺旋形的可膨胀的血管支架54包括第一端56和第二端58,其具有设置在其间的柱形主体件60。柱形主体件60限定与血管支架54的纵向轴线64同轴地对准的中心腔62。螺旋形可膨胀的血管支架54具有第一直径D,由此使得在血管内插入和定位该器件,并且还具有较大的第二直径D’,由此使其与血管壁接合并支承血管壁。如图所示,活性材料选择性地施加到螺旋形的可膨胀的血管支架54的外表面上。图14示出了螺旋形的可膨胀的血管支架54的替代实施例,其包括具有第一端56和第二端58的柱形主体件60。该柱形主体件60还包括至少一个设置在其上的活性部段66,由此使得动脉瘤形成血栓或隔离,同时限制血管阻塞。图15示出了定位在血管14内的本实施例的截面图,其中至少一个活性部段66阻塞或以其它方式抑制流向动脉瘤10的血流。
在再一实施例中,图16-18示出了网状的可膨胀的内腔血管支架。如图16、17所示,网状血管支架68包括第一端70和第二端72,其具有设置在其间的网状主体74。该柱形网状主体74由一系列的互连的支承件24构成,该网状主体限定沿血管支架68的纵向轴线78同轴地对准的流动腔76,其具有第一压紧直径D和较大的第二直径D’。如图16-18所示,活性材料可施加到血管支架68的外部上。或者,活性材料可施加到所选择的区域上,或单独的支承件24可由活性材料制成或以其它方式结合到其中。图18示出了定位在血管14内的网状可膨胀的血管支架68的截面图,其中活性部段80阻塞或以其它方式抑制流向动脉瘤10的血流。
图19示出了本发明的又一实施例。如图19所示,阻塞分叉支承件82包括第一端84、第二端86、和第三端88,并具有在第一端、第二端、和第三端之间的柱形主体90。该柱形主体90还限定一内腔92,其分别与第一端84、第二端86、和第三端88连通。阻塞分叉支承件82具有第一直径D,由此使得在血管内插入和定位该器件,并且还具有较大的第二直径D’,由此使其与血管壁接合。因而,柱形主体90可由多个互锁或以其它方式连接的支承件24制成,并且形成网状。如图19所示,活性材料92结合到柱形主体82中,由此可阻塞形成在血管14上的动脉瘤10。
图20和21示出了本发明的另一实施例,其中披露了定位在动脉瘤10的颈部12附近的在动脉瘤内的颈部桥接结构94。如图所示,在动脉瘤内的颈部桥接结构94包括与至少两个接合件98A、98B连通的器件主体96,接合件98A、98B共同地形成一器件连接部100。本领域的普通技术人员应当理解,该器件连接部100可密封地使得动脉瘤与流经血管的血流隔离。接合件98A-B成形为接近动脉瘤的曲率半径,由此在器件与血管之间提供一界面。活性部分102A-B分别定位在接合件98A-B上。如图12所示,在施加在动脉瘤内的颈部桥接结构94之前或之后,材料104可插入到动脉瘤中。这种材料104可包括多种材料,例如水凝胶、猪鬃、细微纤维胶原、各种聚合物试剂、材料悬浮液、金属材料或不可透过无线电的材料、和其它空间填充材料。
本发明还披露了一种治疗血管动脉瘤的方法。在一个实施例中,本发明披露了一种包括透过皮肤将动脉瘤治疗器件插入到血管中、将该治疗器件推到血管动脉瘤附近的位置处、并在大致不限制流经该血管的血流的情况下使该器件作用于动脉瘤或周围组织的方法。本发明的装置可通过多种方式输送到体内就位,这些方式包括例如在导向线材上、在囊体导管上或通过细微导管。图22示出了通过使用囊体细微导管106应用于动脉瘤10的本发明的示例性实施例104。
在使用中,医生将例如为可膨胀的网状血管支架104的器件定位在例如为细微囊体导管106的输送器件上。其后,第一切口形成在血管附近,并且导向线材108插入其中。通常,导向线材经过股动脉、股静脉、颈静脉、颈动脉、或类似血管进入循环系统。导向线材108可随后经循环系统引导到在动脉瘤10附近的位置处,其后经远端的离开点离开身体。输送器件106和血管支架104可随后沿导向线材108推入并定位在动脉瘤10附近。通常,可视化方法例如荧光镜、超声波成像、或回波定位可用于精确地将输送器件定位在动脉瘤附近或在动脉瘤10中。一旦定位,细微囊体106将充气并且可膨胀的网状血管支架104作用于组织。可膨胀的网状血管支架104的设置有活性材料的一部分定位在动脉瘤附近。其后,输送器件106和导向线材108从身体中取出。选择性地施加到血管支架104上的活性材料110限制或阻塞流向动脉瘤的血流。活化过程可由多种条件启动,例如包括处于生理pH中一定时间、在血液中存在的酶或其它物质、由预定波长的电磁能感应的电磁活化。上述过程披露了一种方法,然而可构想到本领域内的已知的其它活化方法。
尽管本发明参照特定的实施例来描述,但是本发明的描述是示意性的,而不限定本发明。对于本领域的普通技术人员来说,在不脱离由后附的权利要求限定的本发明的精神和范围的情况下,可实现各种变型和应用。
Claims (17)
1.一种用于治疗血管动脉瘤的装置,其包括:
至少一个可膨胀的血管支架,所述可膨胀的血管支架具有位于第一端和第二端之间的柱形的主体件,所述柱形主体件还限定出与所述第一端和第二端连通的内腔,并且还限定出在所述第一端和第二端之间的多个周向开口;
其中,所述至少一个可膨胀的血管支架可在第一直径(D)和第二直径(D’)之间膨胀,其中第二直径(D’)大于第一直径(D);以及
施加到所述血管支架上或与所述血管支架成一体的活性材料,所述活性材料配置成当与动脉瘤位置处的血液接触时发生体积膨胀,所述活性材料选择性地定位在一些所述周向开口附近,以便所述活性材料的膨胀使得流经相邻的周向开口的血流阻力增加。
2.如权利要求1所述的装置,其特征在于,所述活性材料是可膨胀的聚合物或水凝胶。
3.如权利要求1或2所述的装置,其特征在于,所述活性材料基于动脉瘤位置处的血液的pH而发生体积膨胀。
4.如权利要求1所述的装置,其特征在于,所述活性材料是从包括亲水性聚合物和水凝胶的组中选择的。
5.如权利要求1所述的装置,其特征在于,其还包括施加到所述可膨胀的血管支架和所述活性材料中的至少一个上的至少一种治疗试剂。
6.如权利要求1所述的装置,其特征在于,所述活性材料具有未起作用的体积(V)和起作用后的体积(V’),其中起作用后的体积(V’)大于未起作用的体积(V)。
7.如权利要求6所述的装置,其特征在于,所述活性材料在7.4的生理pH中可获得起作用后的体积(V’)。
8.如权利要求1所述的装置,其特征在于,所述活性材料构形成当处于所述起作用后的状态时沿一方向膨胀。
9.如权利要求1所述的装置,其特征在于,所述可膨胀的血管支架包括径向和轴向柔性的网状的分叉的血管支架,其具有位于第一端、第二端、和第三端之间的分叉主体件,所述分叉主体件限定出与所述第一、第二和第三端连通的内腔。
10.如权利要求1所述的装置,其特征在于,其还包括输送器件,所述输送器件可从以下组中选择,该组包括导管、细微导管、囊体导管、可膨胀的导管、导向线材、线材、和细长体;并且所述输送器件包括可控制的松释机构,所述松释机构可从以下组中选择,该组包括机械式、电解式、电动机械式、热力式、液压式、和形状记忆式的松释机构;并且所述至少一个可膨胀的血管支架可输送到体内就位并且可控制地从所述输送器件上松释。
11.如权利要求1所述的装置,其特征在于,所述至少一个可膨胀的血管支架包括至少一个装接器件,该装接器件可从以下组中选择,该组包括倒钩、钩、针、刺、和粘接区域。
12.如权利要求1所述的装置,其特征在于,所述可膨胀的血管支架包括至少一种生物性相容的材料,该材料从以下组中选择,该组包括铂、金、钽、钛、不锈钢、钨、镍钛金属互化物、形状记忆合金、聚氨酯、聚乙烯醇、聚酯、聚四氟乙烯、硅酮、或丙烯酸。
13.如权利要求1所述的装置,其特征在于,所述可膨胀的血管支架包括不可透过无线电的材料以及/或者能够产生回波的材料。
14.如权利要求1所述的装置,其特征在于,所述可膨胀的血管支架包括径向和轴向膨胀的螺旋形血管支架。
15.如权利要求1所述的装置,其特征在于,所述可膨胀的血管支架包括至少一个具有周向开口的可膨胀的编织的血管支架,并且所述活性材料与所述至少一个可膨胀的编织的血管支架交织,所述活性材料具有未起作用的状态和起作用后的状态,其中所述活性材料在所述起作用后的状态中可增加流经所述周向开口的血流阻力。
16.如权利要求1所述的装置,其特征在于,所述可膨胀的血管支架包括至少一个具有周向开口的可膨胀的网状血管支架,其中所述柱形主体件由多个支承件形成,所述支承件可支承血管组织,所述活性材料选择性地施加到特定的所述支承件上,所述活性材料具有未起作用的状态和起作用后的状态,并且所述活性材料在所述起作用后的状态中可增加流经所述周向开口的血流阻力。
17.如权利要求1所述的装置,其特征在于,所述可膨胀的血管支架包括可膨胀的分叉的血管支承器件,该血管支承器件具有位于第一端、第二端、和第三端之间的具有径向和轴向柔性的分叉主体件,所述分叉主体件具有周向开口,其中所述活性材料选择性地施加到所述至少一个支承件的特定周向开口上,所述活性材料具有未起作用的状态和起作用后的状态,其中所述活性材料在所述起作用后的状态中可增加流经所述周向开口的血流阻力。
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EP2016912A2 (en) | 2009-01-21 |
JP2004535868A (ja) | 2004-12-02 |
CA2455464A1 (en) | 2003-01-30 |
EP2314231A1 (en) | 2011-04-27 |
EP2016912B1 (en) | 2017-01-18 |
EP2305141B1 (en) | 2016-08-31 |
EP2305141A1 (en) | 2011-04-06 |
AU2008243176B2 (en) | 2011-01-27 |
BR0211281A (pt) | 2004-12-21 |
EP2314231B1 (en) | 2016-08-10 |
EP2016912A3 (en) | 2009-07-15 |
DE60230278D1 (de) | 2009-01-22 |
JP2007307409A (ja) | 2007-11-29 |
US8562667B2 (en) | 2013-10-22 |
US20030018294A1 (en) | 2003-01-23 |
US20090287297A1 (en) | 2009-11-19 |
EP1411839A1 (en) | 2004-04-28 |
CN101292889A (zh) | 2008-10-29 |
WO2003007823A1 (en) | 2003-01-30 |
EP1411839B1 (en) | 2008-12-10 |
CN1556689A (zh) | 2004-12-22 |
AU2002316320B2 (en) | 2008-08-07 |
ATE416687T1 (de) | 2008-12-15 |
JP4090991B2 (ja) | 2008-05-28 |
CN101292889B (zh) | 2013-02-06 |
US7572288B2 (en) | 2009-08-11 |
AU2002316320C1 (en) | 2009-03-26 |
ES2319397T3 (es) | 2009-05-07 |
CA2455464C (en) | 2010-02-02 |
JP4440953B2 (ja) | 2010-03-24 |
AU2008243176A1 (en) | 2008-12-04 |
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