CN1529572A - 带滑动而锁定的径向元件的可膨胀支架 - Google Patents
带滑动而锁定的径向元件的可膨胀支架 Download PDFInfo
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- CN1529572A CN1529572A CNA018206441A CN01820644A CN1529572A CN 1529572 A CN1529572 A CN 1529572A CN A018206441 A CNA018206441 A CN A018206441A CN 01820644 A CN01820644 A CN 01820644A CN 1529572 A CN1529572 A CN 1529572A
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Abstract
本发明提供一种用于体腔内的有一畅通的通腔的支撑体腔的支架。该支架由至少一系列滑动而锁定的径向元件和至少一个包括一活动连接元件和多个止动件的咬合机构组成。该咬合机构允许这些径向元件从一收缩直径单向滑动到一膨胀直径,但阻止其从膨胀直径沿径向缩回。
Description
发明背景
本发明涉及用于保持体腔支撑的可以膨胀的医疗植入物。
支架的一个重要用途是在脉管壁部分或狭窄斑块阻塞或阻挡脉管中的液流的情况中出现的。在一次经皮的经体腔的冠状血管成形术手续中常常使用一个气囊导管来扩大该脉管的被阻挡部分。但是,该阻挡部分的扩张能够造成动脉粥样硬化斑块的裂开和对内皮和下面的平滑肌细胞层的损伤,可能导致脉管壁中生成皮片或穿孔的紧急问题以及被扩张的脉管的再狭窄的长期问题。植入支架能提供这些问题的解决办法并防止脉管的再封闭或对穿孔的脉管提供斑修补。其次,该支架可以克服患病脉管壁收缩的趋势、从而保持血液更正常地流过该脉管。
所有先有技术的支架都已遇到显著的困难。每个都有血栓形成、再狭窄和组织长入的发生比例数以及各种设计所持有的缺点。
Balcou等人的“对支架的制造、植入和应用的建议”(欧洲心脏杂志,1997年,18卷,1536-1547页)和Phillips等人的《支架手册》(医师出版社,1998年,美国密歇根州伯明翰市)已描述过先前研制的支架的例子。临床使用的第一个支架是包括一个中国顶针环形状的金属网的自动膨胀的“壁支架”。这一设计概念用作今日使用的许多支架的基础。这些支架是从细长的金属丝编织管切割下来的,因此具有在其纵向两端留有从切割过程来的金属丝尖头的缺点。第二个缺点是用于形成该支架的带有铂芯的钴基合金固有的刚度,从损伤健康组织的观点看,这种刚度与终端金属丝尖头一起使得沿去目标脉管的通道到损害部位的血管的通过过程变得困难而又危险。另一缺点是从血流和心肌活动来的连续应力产生显著的血栓形成的危险和对邻近损害的脉管壁的损伤而导致再狭窄。这些种类的支架的主要缺点是其径向膨胀会同时产生其长度的显著缩短,导致当完全展开时不可预测的纵向覆盖。
在随后的设计中,一些最流行的是Palinaz-Schatt的有槽的管子形式的支架。原来,Palmaz-Schatt的支架由包括与活动连接机构相连接的独立区段的有槽不锈钢管组成。这些支架利用一个气囊导管输送到受影响区域,然后膨胀到合适的尺寸。Palinaz-Schatz设计及相似变化方案的缺点是它们在展开后在膨胀时呈现中等的长度缩短和直径的某些缩小或缩回。其次,该膨胀的金属网伴有相当粗糙的终端金属丝尖头,这增大了血栓形成和/或再狭窄的危险。这种设计被认为是该技术的当前状态,即使其厚度为0.004至0.006英寸。
另一类型的支架涉及一种用单股钽丝绕成正弦波螺旋状的管子,称为线圈支架。与Palinaz-Schatz支架比较,线圈支架呈现增大的挠曲度。但是,其缺点是对许多用途(包括钙化的或大块的血管损害)没有足够的支架支撑。其次,线圈支架在径向膨胀后也呈现缩回。
由Fordenbacher描述的一种支架设计使用多个细长的平行的支架部件,每个部件有一带多个对置的周边元件或锻件的纵向支柱。一个支架部件的周边元件织入一相邻支架部件的纵向支柱中的成对的槽内。通过在有槽的活动连接机构中并入锁定机构,Fordenbacher支架可以在径向膨胀后尽可能减小缩回。此外,Fordenbacher支架中的充分数目的周边元件可以提供足够的支持。不幸的是,通过成对的槽伸出的周边元件的自由端部可能造成血栓形成和/或再狭窄的显著危险。而且,由于有多个纵向支柱,该支架设计往往比较不太能挠曲。
一些支架采用“胶冻卷”设计,其中一薄片在其本身上卷拢。在收缩状态下高度重叠,当该支架舒展到膨胀状态时重叠减少。此种设计的例子描述于美国专利Lau的No.5,421,955与Khosravi的No.5,441,515和No.5,618,299及Sigwart的No.5,443,500中。这些设计的缺点是它们往往呈现非常差的纵向挠曲度。在一种改进了纵向挠曲度的改型设计中,多个短的卷沿纵向联接。例如参见美国专利Campbcu的No.5,649,977与Carpenter的No.5,643,314和No.5,735,872。但是,这些联接的卷在相邻的卷之间缺少脉管支撑。
另一形式的金属支架是一种使用Nitinol合金或 涂层的可以热膨胀的线圈的可以热膨胀的器件。这种类型的支架在一个能够容放受热流体的导管上输送到受影响区域。一旦合适地放置,将热盐水通过导管的其上安置该支架的部分送入,使支架膨胀。与这种支架设计有关的缺点很多。该器件遇到的困难有难于获得可靠的膨胀和难于将其保持在膨胀状态。
也可使用自膨胀的支架。这些是当限制在一套管(或其它限制机构)中时输送的,当套管移去时,支架膨胀。自膨胀的支架的问题是需要在0.1至0.2mm膨胀直径内的精确尺寸来充分地减少再狭窄。但是,自膨胀的支架目前仅仅可用于0.5mm增量。因此,需要膨胀尺寸的更大选择性和可适用性。
总而言之,仍然需要一种改进的支架:一种具有更光滑的边缘而能尽可能减小再狭窄的;一种当收缩时小到和可以挠曲到足以能够不复杂地送到受影响区域的;一种在展开时充分挠曲而能符合受影响的体腔的形状的;一种能均匀地膨胀到所要直径而长度不会变化的;一种能保持膨胀尺寸而不会显著缩回的;一种具有充分的支架来提供一个畅通的通腔的;一种使用更薄的壁的设计的;一种能够做得更小和更灵活而到达直径更小的脉管的;以及一种具有更薄的壁的设计而允许更快的内皮愈合或用脉管衬里覆盖该支架的,这转过来尽可能减小了由于暴露的支架材料而形成血栓的危险。
发明概要
本发明涉及一种体腔内的可以膨胀的支架,包括一个有一畅通的通腔的管状部件。该管状部件具有近端和远端与在两端之间限定的纵向长度,以及一圈周边和一个可在至少一第一收缩直径与至少一第二膨胀直径之间调整的直径。在一种优选方案中,当该管状部件在第一收缩直径和第二膨胀直径之间调整时,其纵向长度基本上保持不变。该管状部件包括至少一个由一滑动和锁定的径向元件序列组成的模件,其中每个径向元件形成该管状部件的周边的一部分,而且其中在第一收缩直径或第二膨胀直径时径向元件本身没有重叠。
在一个方面中,每个径向元件可以包括至少一个设置在第一和第二端部之间的细长的肋。最好是,组成一模件的径向元件在具有奇数个细长肋的径向元件和具有偶数个细长肋的径向元件之间交替。在一种优选方案中,这些径向元件在具有一个细长肋的径向元件和具有两个细长肋的径向元件之间交替。
该支架也包括至少一个由一接头片和至少一止动器组成的活动连接机构。该活动连接机构允许径向元件从第一收缩直径向第二膨胀直径单方向滑动,但阻止从第二膨胀直径沿径向缩回。
在该支架的变化方案中,该管状部件可以包括至少两个通过至少一个连接元件而彼此联接的模件。在一种变化方案中,该管状部件还可以包括一个在每个模件中围绕至少一个径向元件的框架元件。在其中该管状部件包括至少两个模件的支架中,此种从相邻模件来的框架元件可以被联接。这种联接可以包括一个延伸在这些框架元件之间的连接元件。此外或替代地,这些从相邻模件来的框架元件可以通过框架元件的互连而联接。在另一方面中,模件间的联接可以是可降解的,允许各独立的模件能够适应脉管的弯曲程度。
在本发明的支架的另一变化方案中,当该管状部件从第一收缩直径调整到第二膨胀直径时,一个模件内的各径向元件之间的重叠量保持恒定。该重叠量最好小于约15%。
按照一个优选实施例,该管状部件的径向缩回小于约5%。该支架的刚度最好小于约0.01牛顿力/毫米偏转。该管状部件最好同时提供一个大于约20%的表面积覆盖率率。
按照本发明的支架的另一变化方案,该管状部件至少是部分不透射线的。这些径向元件可以基本上用一种加工硬化到约80~95%之间的材料制成。在一个优选的变化方案中,该体腔内的可以膨胀的支架中的径向元件是用选自聚合物、金属、陶瓷及其复合的材料制成的。在一种方案中,该材料可以是可降解的。
在本发明的另一方案中,该材料也可以包括一种生物活性剂。该材料最好适合于输送一定量的足以阻止支架的展开部位处的再狭窄的生物活性剂。在一个变化方案中,这些径向元件适合于当该管状部件从第一收缩直径调整到第二膨胀直径时能释放该生物活性剂。该生物活性剂最好选自抗血小板剂、抗血栓形成剂、抗增生剂和消炎药剂。
在另一变化方案中,该管状部件还包括一个鞘,例如在一脉管移植物中。
在一个方面中,该体腔内的可以膨胀的支架包括至少两个模件,其中第一和第二模件的膨胀直径是不同的。
在本发明的允许支架膨胀但阻止其缩回的活动连接机构可以在一个径向元件上包括一槽和一接头片而在一个相邻的径向元件上包括至少一个可以滑动地接合在该槽中的止动件,其中该接头片适合于接合该至少一个止动件。该活动连接机构也可以包括一个在可以滑动地接合的径向元件上的膨胀阻力器件,其中在膨胀期间该膨胀阻力器件阻止通过该槽,直到施加另外的力,使得该模件中的径向元件以基本上均匀的方式膨胀。在另一变化方案中,该活动连接机构可以包括一种松脱装置动作,使得这种松脱装置动作的起动允许径向元件从第二膨胀直径滑动回到第一收缩直径,以便可以移出支架。在另一变化方案中,该支架可以包括一个具有活动连接机构的浮动联接元件。
在另一变化方案中,该体腔内的可以膨胀的支架包括一个有一畅通的通腔和一可在至少一个第一收缩直径和至少一个第二膨胀直径之间调整的直径的管状部件。该管状部件包括一个用一种可降解的材料制成的滑动和锁定的径向元件的序列,其中该序列中的每个径向元件形成该管状部件的周边的一部分,而且其中径向元件本身不重叠。该支架也有至少一个活动连接机构,该机构允许径向元件从第一收缩直径单向滑动到第二膨胀直径,但阻止其从第二膨胀直径沿径向缩回。该可以降解的材料可以选自下列一组物质:聚芳基化物(L-酪氨酸衍生的)、无酸聚芳基化物、聚碳酸酯(L-酪氨酸衍生的)、聚(酯酰胺)、聚(富马酸丙酯共乙二酸乙酯)共聚物、聚酐酯、聚酐、聚原酸酐,以及丝蛋白聚合物、磷酸钙、镁合金或其混合物。
在该可降解的支架的一种变化方案中,该可降解的聚合物还可以包括至少一种生物活性剂,当该材料降解时该生物活性剂被释放。该至少一种生物活性剂可以选自抗血小板剂、抗血栓形成剂、抗增生剂和消炎药剂。
在另一变化方案中,该支架可以是纤维增强的。该增强材料可以是一种可降解的材料如磷酸钙(如生物玻璃)。或者是,维纤维可以是纤维玻璃、石墨或其它不可降解的材料。
在另一方案中,本发明的支架包括一个有一壁和一畅通的通腔的管状部件。该管状部件包括一个自身不会重叠的滑动和锁定的径向元件的序列。这些径向元件还包括一个允许径向元件从第一收缩直径单向滑动到第二膨胀直径的咬合机构。该实施例中的管状部件具有小于约0.01牛顿力/毫米偏转的刚度,而该管状部件的壁具有小于约0.005英寸的厚度。
附图简述
图1A-1C是按照本发明的一种可以膨胀的支架的一个模件的平面图,例示一个径向元件的序列。该装配的模件图示于不同的状态中,从收缩状态(图1A)到部分膨胀的状态(图1B)到膨胀状态(图1C)。
图2A和2B是图1A-1C的单个的径向元件的简图。图2A中示出一个一肋径向元件,图2B中示出一个二肋径向元件。
图3是由一个包括一个一肋和二肋滑动和锁定径向元件序列的模件形成的管状部件的透视图。
图4A和4B是一种有一浮动联接元件的模件的另一实施例的平面图,其中该一肋径向元件还包括一个框架元件。该模件图示处在收缩状态(图4A)和膨胀状态(图4B)中。
图5是一种包括每个有二肋和一框架元件的滑动和锁定径向元件的模件的另一实施例的平面图。
图6是该支架的一种表示每个模件包括交替的一肋和二肋径向元件的相邻的模件的连接的变化方案的平面图,其中该一肋元件有一框架元件,适合便于沿周边轴线连接相邻的模件。
图7是该支架的一种表示通过的相邻框架元件的互连的模件内联接的变化方案的平面图。
图8是该支架的一种表示通过相邻框架元件的相互直接附接的变化方案的平面图。
图9是一种包括一个按照本发明的一个方面的模件的管状部件的透视图。
图10是一种包括多个模件的管状部件的透视图。
图11是一种在一肋径向元件上具有一个浮动联接元件和多个框架元件的模件设计的卡扣在一起的变化方案的平面图。
图12A-12C是表示形成一偏置的或削成斜面的止动件的各步骤的透视图。
图13A和13B表示一种按照本发明的一种可以收缩的变化方案的可以松脱装置的活动连接机构。图13A中示出该可以松脱装置的活动连接机构的各部件的分解图。图13B中示出安置在一个模件上的几个可以松脱装置的活动连接机构的透视图。
图14A和14B表示对于未展开/安装的(收缩直径的)支架(图14A)和对于已展开的(膨胀直径的)支架(图14B)的比较纵向挠曲度。
优选实施例详述
支架设计
本发明涉及一种可沿径向膨胀的支架,用于张开或膨胀体腔中的目标区域。在本发明的一个优选实施例中,该装配好的支架包括一个具有沿纵向轴线的长度和沿径向轴线的直径的尺寸合适的有待插入体腔的管状部件。如下所述,该管状部件的长度和直径可以显著变化,以便展开在不同的选定的目标体腔中,取决于结构件的数目和构型。该管状部件可以至少一个第一收缩直径调整到至少一个第二膨胀直径。在管状部件的结构件中包含一个或多个止动件和接合元件或接头片,由此将“缩回”(即从膨胀直径到较收缩直径的收缩)最大限度地减少到小于约5%。
按照本发明的管状部件有一个“畅通的通腔”,后者定义为没有突入收缩直径或膨胀直径的腔中的结构元件。其次,该管状部件具有光滑的边缘,以尽量减小边缘造成的损伤。该管状部件最好是薄壁的(壁厚取决于选定的材料,从塑料和可降解材料的小于约0.006英寸到金属材料的小于约0.002英寸)和可挠曲的(例如小于约0.01牛顿力/毫米偏转),以便于输送到小脉管中和通过曲折的脉管系统。该薄壁设计也将尽量减小血液紊流和因此产生的形成血栓的危险。按照本发明展开的管状部件的薄壁外形轮廓也有利于支架的较快的内皮愈合。
该管状部件的壁包括至少一个模件,该模件由一系列滑动元件和径向锁定元件组成。最好是,沿纵向轴线通过连接元件连接多个模件,这些连接元件联接至少几个相邻模件之间的径向元件。这些径向元件的形状做成在每个模件内能形成该管状部件的周边。一个模件中的每个径向元件最好是一个分立的单元结构,包括一个或多个沿径向轴线弯曲的周边肋,以形成该管状部件的总周边的一部分。一个模件中的径向元件最好装配成使所有周边肋基本上互相平行。每个径向元件中的至少一个肋有一个或多个沿肋的长度设置的止动件。至少一些径向元件也有至少一个活动连接机构,以便可以滑动地接合从相邻的沿周边偏置的径向元件来的肋。在本发明的一个方面中,该活动连接机构包括一个接头片,用于接合沿可以滑动地接合的相邻肋设置的止动件。一个径向元件的接头片和一个相邻的径向元件的止动件之间的活动连接使得形成一个锁定机构或咬合机构,由此相邻的径向元件可以沿周边彼此分离地滑动,但基本上不能沿周边彼此相向地滑动。因此,该管状部件可以沿径向从一较小直径膨胀到一较大直径,但由于该锁定机构而尽可能减小缩回到较小直径。缩回的量能够通过调节尺寸和沿各个肋的止动件之间的间距而对用途专门设计。最好是,这种缩回小于约5%。
本支架的一些方面公开在颁布给Steinke的美国专利No.6,033,436和待审中的美国申请书No.09/283,800中。其公开内容完全参考合并于此。
参照图1A-1C,图中例示一种模件10的平面图,该模件10包括按照本发明的一个实施例的一个滑动和锁定径向元件20的序列。图示的模件为二维的平面。每个径向元件有一个或多个细长的肋22(沿竖直轴线),带有一个永久固定在每个肋的每个端部上的大体上垂直的端部部分24(沿水平轴线)。每个肋有至少一个止动件30。该模件中的径向元件从一肋构型20′交替为二肋构型20″。例示的一肋构型20′有带多个止动器30的单独一个肋,而例示的二肋构型20″有两个肋,每个肋带多个止动器30。按照本发明的径向元件可以具有不同数目的周边肋22,但是,沿垂直方向相邻的径向元件最好在一种奇数肋构型和一种偶数肋构型之间交替,如图1A-1C中所示。
相邻的径向元件中的奇-偶交替便于周边肋22内模件中的嵌套而同时保持一个恒定的宽度(W)。但是,如果这些径向元件做成不同形状,例如平行四边形而不是矩形,其中这些肋呈现一种非周边的取向,那么在该管状部件膨胀时将出现模件沿轴向长度的变化。这类变更包括在本发明中。
参照图1A-1C,图示设计中的径向元件20的一些端部部分24示有活动连接机构34,每个机构34包括一个槽36和一个接头片32,槽36用于可以滑动地接合一垂直相邻的径向元件的肋,而接头片32用于接合该可以滑动地接合的肋中的止动件30。一肋径向元件20′的端部部分24通常适合于活动连接可以滑动地接合的垂直相邻的二肋径向元件20″的每个肋22。二肋径向元件20″的端部部分24通常适合于活动连接可以滑动地接合的垂直相邻的一肋径向元件20′的单独肋22。该活动连接机构更详细地示于图2A和2B中。止动件30可以沿整个长度均匀地分布(如从底部算起的第二个径向元件上所示),或者止动件也可沿这些筋不均匀地分布(如最上面的径向元件中所示)。
一个径向元件的接头片32和一个相邻的径向元件的止动件30之间的活动连接产生一个锁定机构或咬合机构,使得只能产生单向的滑动(膨胀)。因此,如图1A-1C中所示的平面图中的径向元件序列可以从图1A中所示的收缩状态调整到图1B中所示的部分膨胀状态到图1C中所示的完全膨胀状态。平面图中模件10的膨胀可以通过施加相反的力(箭头)来实现。嵌套的滑动而锁定的径向元件20彼此相离地滑动,从而增大该系列沿竖直轴线的高度(h),而不改变该序列沿水平轴线的宽度(W)。由接头片32和单个止动件30之间的活动连接形成的锁定机构防止已膨胀的系列缩回到更加缩回的高度。
当模件10转动而形成一管状部件时,在模件顶部上的径向元件上的端部和从模件底部上的径向元件来的肋之间可以形成一个可滑动的活动连接。同样,在模件底部上的径向元件上的端部和从模件顶部上的径向元件来的两个肋之间可以形成一个可滑动的活动连接。在一种变化方案中,在转动而形成一管状部件后,能够用该技术中已知的各种固定机构包括焊接、粘合、机械固定机构或卡扣固定机构等使顶部和底部两个端部互相连接。换句话说,可以包括专用的结构件来便于联接该转动的模件的顶部和底部两部分。下面参照图4A和4B详述专用的周边联接元件的例子。
参照图2A和2B,分别更详细地示出单个的一肋20′和二肋20″径向元件。图2A中的一肋径向元件20′和图2B中的二肋径向元件20″有至少一个周边肋22和在该肋的每端上的一个端部24。该肋有一个或多个沿肋22的长度设置的止动件30。每个例示的径向元件的一端包括一个由一接头片32和一槽组成的活动连接机构34。图2A和2B中也例示连接元件40,该元件从径向元件的端部24侧向伸出。这些连接元件40用于联接相邻模件之间的径向元件。这些连接元件可以从一肋20′或二肋20″径向元件的任一个的一端或两端24伸出。在一种优选方式(如图示)中,这些连接元件40从一肋径向元件20′的两个端部24伸出。这些连接元件的构型和角度可以变化,基本上取决于模件之间的所要连接距离和支架的所要的挠曲能力和复盖的表面积。
图3中示出一个由一个单独的模件10形成的管状部件,包括类似于参照图1A-1D和图2A-2B所述的平面图的四个一肋径向元件20′和四个二肋径向元件20″。这些形成管状部件壁的径向元件在具有奇数和偶数的周边肋22之间交替。图示的模件中的每个肋有一个或多个止动件30。一个活动连接机构(图2A和2B中更详细地示出)有一个接头片32,该接头片32接合止动件并防止该管状部件收缩到更小的直径。每个径向元件组成该管状部件的总圆周的一部分(这种情况下为圆周的1/8)。优选的是,组成一个模件的径向元件的总数在约2至12之间变化。更优选的是,径向元件的数目为4至8个。图中示出连接元件40从模件两侧沿侧向伸出。连接元件40用于将该模件联接到相似的模件上,以形成具有更大的纵向长度的管状部件。
图4A和4B中示出上述参照图1A-1D和图2A-2B的基本模件设计的变化方案。该模件在平面图中例示成收缩状态(图4A)和膨胀状态(图4B)两种。在支架的这种变型中,与早先的设计相似,模件110包括一个滑动和锁定径向元件120的序列。每个径向元件有一个或多个细长的肋122(沿竖直轴线),带有一个永久固定在每个肋的每端上的基本上垂直的端部124(沿水平轴线)。每个肋有一个或多个止动件130。该模件中的径向元件从一肋构型120′交替为二肋构型120″。一肋构型120′有一个带一或多个止动件130的单独肋122,而二肋构型120″有两个肋,每个肋带一个或多个止动件130。
像先前描述的模件一样,相邻径向元件中的奇-偶交替便于将周边肋122嵌套在一个模件中而保持一个恒定的宽度(W)。图示设计中的径向元件120的一些端部124表示成带有活动机构134,每个活动机构134由一个用于可滑动地接合一个从一竖直相邻的径向元件来的肋的槽136和一个用于接合该可以滑动地接合的肋中的止动件130的接头片132。图4A和4B中示出的活动连接机构134的羽毛状边缘138指示在该处该活动连接机构已焊接在各自的径向元件的端部124上,从而产生槽136,该接合的肋能够通过该槽而滑动。一肋径向元件120′的两个端部124通常适合于与从可以滑动地接合的竖直相邻的二肋径向元件120″来的每个肋122活动连接。二肋径向元件120″的两个端部124通常适合于与可以滑动地接合的竖直相邻的一肋径向元件120′的单独肋122活动连接。止动件130可以沿整个长度(如图所示)均匀分布,或者止动件可以沿肋不均匀地分布,或者可以只有一个单独的止动件。
在图4A和4B中,在一肋径向元件120′上也示出一个凸缘161。能够沿该肋的长度包括这些凸缘,以便提供一个暂时的止动件。在膨胀期间,当凸缘161进入活动连接机构138的槽136中时,带有凸缘161的肋暂时停止滑动。在该暂时停止被额外的径向膨胀力克服之前,这种暂时的停止允许其它元件完全膨胀。在模件中包括一个或多个这种凸缘,便于径向元件在模块中的均匀膨胀。在由凸缘161产生的暂时停止之外或作为替代,一些元件可以只有一个止动件,使得该元件首先膨胀到该止动件,而其它元件具有多个提供优选的膨胀步骤的止动件。
从一个径向元件来的接头片132和从一个相邻的径向元件来的止动件130之间的活动连接形成一个锁定机构或咬合机构,使得只能产生单向滑动(膨胀)。嵌套的、滑动的和锁定的径向元件120互相离开地滑动,从而增大该序列到沿竖直轴线的高度,而并不改变该序列到沿水平轴线的宽度。由接头片132和单个止动件130之间的活动连接形成的锁定机构防止该膨胀的序列缩回到一个更收缩的高度。
图4A和4B中所示的模件110包括一个其形状像二肋径向元件120″的端部124的浮动联接元件150,它有一个适合于可以滑动地接合一肋径向元件120′的周边肋122。在图示实施例的变化方案中,该浮动联接元件可以适合于浮动在具有两个或更多个周边肋的径向元件的多于一个的肋上。联接元件150也适合于联接该序列中顶部径向元件121的端部124。联接元件150和顶部径向元件121上的端部124两者的形状做成具有联接臂152、1543和152′、154′,它们可以如图所示地呈现一种互补的构型。
图4A和4B中例示的另一个专门机构是框架元件160,从其沿侧向离开框架元件160地伸出连接元件140。在图4A和4B中所示的模件中,只在一肋径向元件120′上利用框架元件160。图示的框架元件附接和延伸在一肋径向元件120′的两个端部124之间,使得周边肋122受到两个端部124和两个框架元件160的围绕或框住。利用框架元件来便于联接相邻的模件有几个好处。这些框架元件对脉管壁产生附加的物理支撑。单个元件的较大的表面积在某些情况下可能是希望的,首先对周围的体腔提供更大的支撑,其次,较大的表面积对生物活性剂的部位导向引入(下面讨论)提供更大的载体。或者是,能够做成较小的表面来尽量减小支架材料对脉管壁的撞击,例如使用狭窄的肋和框架元件。通过从径向元件沿侧向向外悬置连接元件140,这些框架元件尽可能减小连接元件140的联接相邻模件所需的长度,而同时使一个模件的滑动肋与相邻模件的滑动肋隔开。相邻模件中连接元件140的联接形成一个挠曲度非常大的支架。框架元件160也承载弯曲,允许大得多的运动,因而增大了挠曲度。在这种方式的变化方案中,框架元件能够用于具有多于一个肋的径向元件中。参见例如图5,该图表示一种包括一个二肋径向元件序列的模件设计,每个元件有多个框架元件。
参照图5,示出一种奇-偶径向元件的变化方案,其中这两个例示的径向元件220中的每个有两个周边肋222和两个活动连接机构234,后者设置在径向元件的至少一个端部224上并包括一个接头片232和一个槽236。像本发明的先前的方案中一样,这些周边肋可以具有多个沿肋的长度设置的止动件230。每个径向元件有一框架元件260,其形状基本上为矩形(未示出连接元件)。该框架元件可以是与围绕这些肋的功能一致并提供一个用于联接相邻模件的径向元件的连接点的任何形状。这些框架元件最好能嵌套处于收缩和膨胀两种状态的肋,而不会重叠支架部件,这将增大支架的厚度。
这些框架元件的形状能够变化,以产生具有奇偶数的肋的不同径向元件的周边平衡。例如,参照图6,从一个模件来的一对径向元件(一个一肋径向元件320′和一个二肋径向元件320″)的侧向联接件连接在从一相邻模件来的另一对径向元件的连接元件340上。在该实施例中图示的框架元件360仅围绕一肋径向元件320′。框架元件360的形状做成有助于肋322和框架元件360的嵌套(而不重叠),尽可能减小模件之间的侧向空间,并便于沿周边而非纵向取向的连接元件340的连接,从而尽可能减小周边的搭架和径向支承件。
参照图7,图示一种相邻模件之间的联接机构的变化方案。不使用独立的连接元件。相反,相邻模件的框架元件可以通过交织而装配成如图所示的互相交连。相邻模件之间的这种联接允许支架有大得多的挠曲度。
参照图8,图示一种相邻模件之间的联接机构的另一变化方案。不使用独立的连接元件。相反,相邻模件的框架元件360如图所示地互相结合。相邻模件的框架元件可以通过任何适用于该材料的手段如焊接等而附接在一起。在一个实施例中,相邻模件的框架元件可以从单独一块材料制成(如切割)。相邻模件的框架元件的这种直接联接有利于产生一种轴向强度更大的支架。
本发明包括各种各样的不同的活动连接机构;包括(但不限于)图1-8中例示公开的槽和接头片设计,以及其母体案子现Steinke的美国专利No.6,033,436中公开的设计,后者完全参考合并于此。
该技术的专业人员将会理解,一个滑动而锁定的径向元件序列的基本的模件设计给制造商提供关于支架的收缩和膨胀的直径以及纵向长度的更大的挠曲度。通过增加每个模件内的径向元件的数目,能够增大膨胀直径和膨胀比。通过增加连接而形成管状部件的模件的数目(从图9中所示的一个模件到图10所示的六个模件),能够增大纵向长度。
参照图9,一种管状部件只有一个包括四个径向元件(两个一肋径向元件420′和两个二肋径向元件420″)的序列的模块410。在图示的模件410中,不使用如图4A和4B所述的浮动联接元件之类的专用联接元件,虽然可以使用这样一种联接元件而并不偏离该基本设计。图示的框架元件460为矩形并仅围绕一肋径向元件420′。图9中所示的模件为膨胀状态,由于通过一个径向元件的活动连接机构434上的接头片432和相邻径向元件的可滑动地接合的肋422上的止动件430之间的活动连接而产生的咬合作用的效果,只受到最小的缩回或收缩(<约5%)。该活动连接机构表示成一个独立的结构件,该结构件已经例如通过焊接固定在相应的径向元件的端部424上,从而连接和可滑动地接合相邻径向元件的肋。
图10中示出按照本发明的一种支架,该固定模包括一个有六个沿纵向轴线连接的模件510的管状部件500(为清楚起见,延伸在相邻模件的框架元件之间的连接元件没有示出)。
图11例示出本发明的另一变化方案的一个径向元件序列,其中活动连接机构是通过在一个单向锁定槽633中的接头片632而形成的。该设计不需要例如通过焊接来附接一个重叠的活动连接机构以连接和可滑动地接合相邻径向元件的周边肋。如图11中所示,在中心锁定槽633的一端设置一个进口槽631,中心锁定槽633是在每个径向元件中沿每个肋的长度的至少一部分设置的。进口槽631适合于允许一个径向元件620的端部624上的一个接头片632装入和接合肋中的锁定槽633。一旦接头片632通过进口槽631安置就位,径向元件620就能够足够地滑动离开而防止接头片632回到进口槽631之外。锁定槽633适合于允许接头片只沿一个方向滑动通过该槽(到更膨胀的构型)。例如,如图所示,锁定槽633有一系列锯齿形的切口或止动件630,这些切口偏置在槽的两侧并允许接头片632沿一个方向移动通动槽633,但其形状能接合该接头片而不许接头片沿相反方向移动通过该槽,即防止已膨胀的支架收缩。任何各种各样的锁定槽和止动件构型均匀包括在该卡扣在一起的设计中。在其母体申请现Steinke的美国专利No.6,033,436中公开了一些替换的锁定槽和止动件构型。
图11中例示的无焊接设计的模件示有框架元件660,该元件660带有围绕一肋径向元件的连接元件640和一个浮动联接元件650,元件650带有联接臂652和654,用于配接该序列中的顶部径向元件的端部624上的互补的联接臂652′和654′。因为能够对这些框架元件进行模件间的联接,这种增大的长度使该支架在收缩和膨胀两种状态方面挠曲度都非常大。
本发明的另一种变化方案包括变化活动连接机构和肋的构型,从而产生随逐渐膨胀而增大的摩擦。这种变化方案可以便于一个模件内所有径向元件的均匀膨胀。
在本发明的另一种变化方案,支架中的不同模件可以呈现不同的膨胀直径,使得该支架可以沿其长度调整到不同的体腔状态。因此,该支架可以在其展开状态中呈现一种锥形构型,其一端有一较大的直径,向着其另一端逐渐地或步进地缩小模件的膨胀直径。该技术的专业人员将会理解,本发明的联锁而滑动的径向元件设计给制造商提供了为不同用途定做支架时的显著的挠曲度。因为支架部件的重叠由于肋和框架元件的嵌套而减到最小,所以收缩的轮廓能够非常薄而不牺牲径向强度。而且,在膨胀期间,与通过卷绕片的解绕而膨胀的胶冻卷设计不同,重叠程度不会显著变化。其次,通过改变所有的侧向连接元件的长度、构型和数目,能够专门设计该支架的展开的灵活性。因此,该支架的灵活的和超薄的实施例肯定能独特地适合于展开在小而难以到达的脉管中,如远到颈动脉和更远的冠状动脉的颅间脉管。
在另一变化方案中,该支架可以与一个套或鞘联用来提供一种例如治疗动脉瘤用的脉管移植物。下面详细地描述制造包括该支架设计的脉管移植物(支架和鞘)的材料和方法。
在本发明的另一变化方案中,沿伸长的肋设置的止动件的形状可以做成便于将活动连接部件的接头片锁定在该止动件内,其中孔的形状适合于提供一个通道,该通道有一捕获经过通道滑动的部件(如接头片)的偏置力。参照图12A-12C,图中例示形成这样一种止动片的一个实施例的步骤。在图12A中,能够从顶部700′和底部700″的表面腐蚀支架700。顶面和底面在某些区域702′和702″分别用防腐蚀层涂敷或屏蔽(如通过化学法、激光法等),在顶面和底面分别留下易受腐蚀的未涂层区704′和704″。这两个未涂层区分别偏移一距离706,这使得在顶面和底面未涂层区704′和704″之间能够有某些重叠区708。如图12B中所示,在除去支架的腐蚀过程期间,未涂层区704′和704″成为通过支架材料延伸的空腔710。如图12C中所示,在腐蚀过程期间,在某些点,这些空腔在重叠区708中相遇而形成一通孔或通道712。于是该止动件形成一个削成斜面的边缘,对经过该止动件滑动的接头片是能够将其捕获地偏置的。
在本支架的另一实施例中,锁定机构可以设计成可松脱装置的,其中该支架可以收缩而从体腔中移出。尽管本公开中的其它构型设计用于永久锁定膨胀状态的部件,但可能需要一种可以逆转的或解锁的机构。图13A中用分解图例示一种可能的松脱装置机构的部件。按照本发明的支架的大多数方面如前所述。但是,活动机构1034换成可以松脱装置的。接头片1032预成形或偏置成(由于其弹性材料和/或展开的角度)并不可以锁定地接合单个止动件1030。相反,在接头片1032上面安置一个可以移动的滑动片1080和制动板1090,以便使接头片向下偏转而进入单个的止动件。被滑动件1080和止动板1090对着肋1022偏转的接头片1032的形状锁定肋1022,使其不能沿一个方向移动(收缩)而能够沿相反方向移动(膨胀)。滑动片1080有一宽阔区1082,能对将接头片1032弯入锁定位置中产生构造上的妨碍。在宽阔区1082置于止动板1090和接头片1032之间的时候,当肋1022滑动通过该活动机构时,该接头片被迫对着可以滑动地接合的肋1022并进入经过的止动件1032。滑动片1080还有一个狭窄区1084能允许接头片1032松开而脱出止动件1030。通过从肋1020的垂直平面中拉出滑动片1080,狭窄区1084重新安置在接头片1032上方,从而允许该接头片从止动件1030松脱装置并对着止动板1090向上弹回。
参照图13B,图示一种具有一肋和二肋径向元件与可以松脱装置的活动连接机构1034的模件的部分视图。图示的一肋径向元件上的可以松脱装置的活动连接机构接合相邻二肋径向元件的两个肋。该可以松脱装置的活动连接机构上的滑动片可以改成有两个狭窄区,用于通过拉动滑动片的一侧而松脱装置两个接头片。
支架的制造
制造本发明的支架的优选材料包括316不锈钢、钽、钛、钨、金、铂、铱、铑及其合金。按照本发明也可使用形状记忆合金如Nitinol。最好是,板材在形成单个支架部件之前先加工硬化。加工硬化的方法在该技术中是熟知的。板材在压力下辗压,加热退火,然后再加工。这可以继续到获得所要的硬度模量。目前商用的大多数支架使用0%至10%的加工硬化材料以考虑“更软”的材料来变形到较大的直径。相反,因为按照本发明的滑动和锁定的径向元件的膨胀取决于滑动而非材料形变,所以最好使用较硬的材料的优选范围为约25~95%加工硬化的材料,以考虑较薄的支架的厚度。更优选的材料为50~90%加工硬化的,而最优选的材料为80~85%加工硬化的。
从金属板材形成单个元件的优选方法可以是激光切割、激光烧蚀、冲切、化学腐蚀、等离子体腐蚀或该技术中已知的能够产生高分辨率部件的其它方法。在一些实施例中,制造方法取决于用来形成支架的材料。化学腐蚀以较低的价格提供高分辨率部件,特别是与竞争性的激光切割产品的高成本相比。平头焊接、胶粘剂、机械附接(卡扣在一起)和该技术已知的其它附接方法,均可用于固定这些单个元件。某些方法考虑到不同的前后腐蚀工件,它们可以形成削成斜面的边缘,它们有望帮助改进锁定的接合。
在本发明的一种优选方式中,支架至少部分地用可以降解的聚合物材料制成。使用可降解的支架的动力是其机械支撑在血管形成后可能只需几星期,特别是如果它也通过输送药理学药剂来控制再狭窄和血栓形成的话。可降解的聚合物支架材料良好地适用于药物输送。
据信需要短斯手术,因为大多数心脏病发生在头六个月中,包括支架内的再狭窄。金属支架的永久性出现长期风险和复杂性。由于长期损害和完全复盖,金属的支架也能妨碍重新外科手术。理想的植入物:(1)在尺寸、形状和材料一致性方面酷似其设计替代的组织;(2)安置不会引起感染也不会引起异体响应;(3)是一种当天然组织消失时具有天然组织特性的临时假体;(4)是一种具有光滑表面以尽可能减小血栓形成和巨噬细胞酶活性的可以生物兼容的植入物。
可降解的支架具有其性能更像一种理想的植入物的潜力。与活宿主组织无缝地一体化的可降解的支架由于其临时居留而可以改善组织的生物可兼容性。由于固定患病组织的初始强度,此种支架可以消除对产品随时间而移动和长期产品的失效的担心。它们还可以尽可能减少与特定部位和邻近部位的重新手术相关的时间、费用和复杂性。可降解的支架对金属的支架的一个明显优点是它们能够给患病组织施药,与涂敷药物的金属的支架相比,可降解的支架能够时间更长地向组织给药。
与血管成形术之后的再狭窄不同,支架内的再狭窄几乎完全是组织增生的结果,主要出现在支架的支撑撞击动脉壁的那些点上。过硬的支架对着柔性脉管的安置产生一种机械行为的不匹配,这种不匹配在动脉壁上产生连续的侧向可膨胀的应力。该应力能促进血栓形成、动脉壁变薄或过多的细胞增生。因此,更柔性的聚合物是物材料可以尽可能减少病理学疾病,并且似乎更接近天然组织的机械轮廓。
健康动脉的未受损的内弹性层(IEL)用作有效的屏蔽,以(1)保护下面的平滑肌细胞(SMC)不暴露于诱发增生的有丝分裂原;(2)防止暴露于能促进硬斑形成和动脉变窄的单细胞或充满脂质的巨噬细胞和循环弹性蛋白肽。一种生物材料的支架可以通过模仿IEL的屏蔽作用而尽可能减小疾病状态的进行,这是由于:(1)通过输送一种细胞循环抑制剂来抵消有丝分裂原的影响;(2)通过用作对通行的免疫细胞的临时物理载体。
在天然的疾病状态动脉狭窄和动脉粥样硬化中,动脉能够有一种受损的或结构上不连续的IEL。这种不连续性的原因多半还不清楚。弹性蛋白酶、循环弹性蛋白肽和弹性蛋白受体可能与内皮的剥脱一起起关键作用。一种不过分膨胀脉管壁的生物材料的支架可以尽可能减小IEL进一步穿孔的危险。此外,支架的表面能够用作形成内皮衬里以及血液成分和循环分子的守卫者用的固定部位。
在本发明的可降解的支架的一种方式中,其基体可以做成释放一种药理学药剂。患病脉管通过血管成形术和支架手术的机械处理能进一步损伤动脉壁。遗憾的是伴随着6~24个月手术后的再闭合,这些手术中的每一种都能够促进血栓形成和再狭窄。这些不充分的临床后果是发展许多对抗的疗法的动力。再狭窄的一些新的治疗方法使用放射性同位素、帕克里塔克素(Paclitaxel)和雷帕霉素(Rapamycin),后两者抑制血管细胞的增生。
据估算,再狭窄的药理学手术需要在血管成形术或支架植入后连续进行2~4星期。同样据估算,一个聚合物的支架能够输送的药剂量10倍于全身性输送。如果从一个可降解的支架释放一种细胞循环抑制剂,那么就可以获得患病脉管中的最佳的长期开通。
可降解的生物材料的支架可以提高产品的长期安全性和对病人的有效性。我们相信,一种在展开后能在脉管中停留几星期的可以完全降解的析出药物的支架在控制再狭窄方面将是有效的。因此,本发明包括具有上述滑动和锁定几何构型的支架,其中其部件是用功能性生物材料制成的。按照本发明,选择该可降解的生物材料的机械性能具有下列特性中的至少一种和最好数种:(1)抵抗由于天然脉管的多轴线的应力-应变行为而产生的失效并超过已知不能用于支架用途的退火金属的应力-应变行为;(2)在展开后的数星期或数月期间保持机械强度;(3)最好带有表面腐蚀地通过水解或酶降解作用而降解,由此使该植入物均匀地降解,并在其降解时保持其初始形状;(4)保持有利的血液动力学行为;(5)呈现一个亲水的带负电的其临界表面张力低的光滑而均匀的表面;(6)有利于内皮愈合;(7)无毒而从身体中安全地消失,也即没有全身性影响;(8)包括一种抗再狭窄的药理学药剂;该药理学药剂可以是一种抑制SMC增生、允许或早或晚的有利的再生和在该生物材料中稳定的细胞循环抑制剂;该可降解生物材料和药理学药剂最好提供约3~4星期的疾患或通过支架的降解周期的剂量。
按照本发明的一个方面的可降解塑料或天然的(动物、植物或微生物)或重组体材料可以包括聚缩肽类、尼龙共聚多酰亚胺、常规的聚氨基酸合成聚合物、假聚氨基酸、脂肪族聚酯如聚乙醇酸(PGA)、聚乳酸(PLA)、琥珀酸亚烃酯、聚羟基丁酸酯(PHB)、二乙醇酸聚丁烯酯和聚ε-己内酯(PCL)、聚二氢吡喃、聚磷腈、聚原酸酯、聚氰基丙烯酸酯、聚酐、聚缩酮、聚乙缩醛、聚a羟基酯、聚碳酸酯、聚亚氨基碳酸酯、聚3-羟基酯、聚肽及其化学变体和组合(混合物和共聚物)以及该技术中已知的许多其它可降解物质(见如Atala,A.、Mooney,D.的《合成的可生物降解的聚合物支架》,1997年,Birkhauser出版社,美国波士顿;参考合并于此)。
在一种优选方式中,该可降解的物质选自下列一组物质:聚草酸亚烃酯、聚链烷酸酯(polyalkanotes)、聚酰胺、聚阿司帕地姆酸(polyaspartimic acid)、聚格鲁塔如恩酸(polyglutarunic acid)聚合物、聚-p-二阿克萨诺恩(poly-p-diaxanone)(如从Ethicon来的PDS)、聚磷腈和聚尿烷。
在一种更优选的方式中,该可降解的物质选自下列一组物质:聚(乙交酯-三甲撑碳酸酯);三聚物(乙交酯、丙交酯或碳酸三甲撑二甲酯的共聚物);聚羟基链烷酸酯(polyhydroxyalkaxoates)(PHA);聚羟基丁酸酯(PHB)和聚(羟基丁酸酯共戊酸酯)(PHB共HV)及其共聚物;聚(ε-己内酯)和共聚物(如丙交酯或乙交酯);聚(ε-己内酯)-碳酸三甲撑二甲酯);聚乙醇酸(PGA);聚L和聚D(乳酸)和共聚物及添加剂(如磷酸钙玻璃)以及乳酸/乙二醇共聚物。
在一种最优选的方式中,该可降解物质选自下列一组物质:聚芳基化物(L-酪氨酸衍生的)或无酸聚芳基化物、聚碳酸酯(L-酪氨酸衍生的)、聚(酯酰胺)、聚(富马酸丙酯共乙二醇乙酯)共聚物(即富马酸酐)、聚酐酯(机械强度较大)和聚酐(机械强度较小)、聚原酸酮、ProLastin或丝弹性蛋白聚合物(SELP)、磷酸钙(生物玻璃)、镁合金和单独使用或在任何化合物中的PLA、PCL、PGA酯商业聚合物的组成。
天然聚合物(生物聚合物)包括任何蛋白质或肽。这些能够用于与任何其它上述可降解物质以及与药理学物质或与水凝胶的混合物或共聚物,或者单独使用。通常,这些生物聚合物在酶的作用下降解。优选的生物聚合物可以选自下列一组物质:藻酸盐、纤维素和酯、脱乙酰壳多糖(NOCC和NOOC-G)、胶原蛋白、棉花、葡聚糖、弹性蛋白、纤维蛋白、明胶、透明质酸、羟基磷灰石、蜘蛛丝、其它聚肽和蛋白质,以及其任何组合。
可降解的和金属的支架用的涂层物质可以选自下列一组物质:水凝胶,如NO-羟甲基脱乙酰壳多糖(NOCC)、带药物(内膜层)和无药的第二层(血流接触)的PEG二丙烯酸酯、聚氧化乙烯、聚乙烯醇(PVA)、PE氧化物、聚乙烯吡咯烷酮(PVP)、聚格鲁塔如恩(polyglutarunic)酸聚合物、DMSO或醇类及其任何组合。
在使用塑料和/或可降解物质的场合,可以利用热冲头模压产生部件和热桩以附接连接元件和联接臂来制造元件。其它优选方法包括利用屏蔽、模板或掩模的激光烧蚀;溶剂浇铸;通过冲压、压纹、压力模制、向心自旋铸造和模制的成形;挤压和切削、利用固体无形制造技术的三维快速造型、立体平版印刷术、选择激光烧结等;包括等离子体刻蚀的刻蚀技术;包括毡化、针织或编织的纺织品制造方法;包括熔化沉积造型、注射模制、室温硫化(RTV)模制或硅酮橡胶模制的模制技术;包括溶剂浇铸、直接壳体生产铸造、失蜡铸造、压力模具铸造、树脂注射、树脂加工由成形或反应注射模制(RIM)的模制技术。这些部件可以利用溶剂或热粘或机械附接而连接或附接。优选的结合方法包括使用超声射频或其它热方法以及利用溶剂或胶粘剂或紫外固化处理或光反应处理。元件可以通过热成形、冷成形、溶剂弱化成形和蒸发或通过在连接前预成形来辗压。也可以使用可溶物质如用血液中的水进行水解的水凝胶,例如交联的聚甲基丙烯酸2-羟基乙酯(PHEMA)及其共聚物如聚丙烯酰胺和聚乙烯醇。
为了便于支架的追踪和定位,可以在任何制造方法中加入射线镇静剂(即不透射线的物质),或将其吸收到部分或全部植入物中或喷洒在其表面上。射线镇静对比度能够通过植入物含量而改变。可以通过共价结合的碘将射线镇静性能给予植入物元件的聚合物单体结构单元。常用的不透射线的物质包括硫酸钡、碱式碳酸铋和二氧化锆。其它不透射线的元素包括镉、钨、金、钽、铋、铂、铱和铑。在一种优选实施例中,可以因其射线镇静性能和抗微生物性能而使用碘。射线镇静性能通常由荧光镜或X射线胶片确定。
按照本发明的支架也可以用于脉管移植物中,其中该支架覆盖一个鞘,由聚合物物质如膨胀的PTEE、可降解聚合物或天然物质如纤维蛋白、心包组织或其衍生物以及该技术专业人员已知的物质组成。或者是,该支架可以埋置在覆盖物质层中。
一旦支架部件已被切割出装配成平面模件(见图1、2、4~8和11所述平面图)而相邻模件之间的连接元件已连接(如通过焊接、交织框架元件等),就卷绕该平板材料而形成一管状部件。结合(如通过焊接)以浮动联接元件和端部来的联接臂,以保持管状。在并不包括联接元件的实施例中,可以结合一个模件中的顶部和底部径向元件的端部。或者是,在整个周边需要滑动的场合,在顶部径向元件的端部和底部径向元件的肋之间可以做成滑动而锁定的活动连接(例如通过平头焊接、加热桩或卡扣在一起)。同样,也可以在底部径向元件的端部部分和顶部径向元件的肋之间做成相应的活动连接。
模件卷合成管状部件能够用该技术中已知的任何方法来完成,包括两块板之间的卷合,这两块板每块都与该支架元件接触地装垫在侧面上。一块板保持不动,另一块板能够相对于第一块板沿侧向移动。因此,夹在两板之间的支架元件可以通过两板相对运动而围绕一芯棒卷合。或者是,可以利用该技术中已知的三向芯轴法来卷合该管状部件。按照本发明可以使用的其它卷合方法包括那些用于“胶冻卷”设计的方法,如美国专利 No.5,421,955;No.5,441,515;No.5,618,299;No.5,443,500;No.5,649,977;No.5,643,314;No.5,735,872中所公开的,其公开内容完全参考合并于此。
这种形式的支架的构造提供许多超过先有技术的优点。锁定机构的构造大半取决于材料。这使得该支架的结构能够包括高强度材料,不可能采用需要材料的变形来完成该锁定机构的设计。包括这些材料将允许材料所需厚度减小,而保留较厚的支架的强度特征。在优选实施例中,在选定的周边肋上存在的锁定孔或止动件的频度防止膨胀后的支架的不必要的缩回。
结合在支架中的药物
药物或其他生物活性化合物能够结合在可降解基质本身中或涂敷在不可降解的支架材料上,由此提供此种化合物在支架部位处的持续释放。此外,可降解的生物材料能够以各种形式制造并加入到该支架的部件去。优选的生物材料将包括一种在制造该支架之前与该可降解的聚合物混合的药剂。优选的药剂控制再狭窄(包括新内膜变厚、内膜增生和支架内再狭窄)或限制移入支架的脉管的腔内脉管平滑肌细胞的过度生长。其它人体用途可能需要不同的药物。
在本发明的另一方面中,该支架的生物材料也可以包括一种用来防止血细胞、细胞外基质或其它类型细胞的粘附的水凝胶,如NOCC和NOCC-G脱乙酰壳多糖。在另一方面中,该药剂或水凝胶能够单独地或在混合物中或与将该药剂或水凝胶粘附或吸收在该生物材料表面上所需的其它结合剂组合地涂敷在该生物材料的表面上。此外或替代地,该药剂或水凝胶或基因物质可以与生物材料聚合物、微小球体或水凝胶结合。
具有选定的功能或化学性能的合成的、天然的(植物的微生物的、病毒的或动物来源的)和重新组合的形式能够与互补的物质(如抗血栓形成的和抗再狭窄的物质;核酸和脂类络合物)混合使用。药理学药剂也可以结合使用维生素或矿物质,例如,通过涉及氨基酸、核酸(DNA、RNA)、蛋白质或肽(如RGD肽)、碳水化合物部分、多糖、脂质体或其它细胞成分或细胞器如受体和配体的相互作用或机制而直接或间接地起作用的那些。
药剂可以是极性的或具有净质电荷或净正电荷或中性电荷;药剂可以是疏水的、亲水的或两性离子的或对水具有极大的亲和力。释放可以通过受控释放机构、扩散、与通过静脉内注射输送的另一药剂的相互作用、雾化作用或口服来发生。释放也可以通过外加磁场、电场或使用超声来发生。
可以用于涂导金属支架或用于并入可降解的支架材料的化合物的种类已由Tanguay等人的《心临床学》(1994)和Nikol等人的《动脉粥样硬化》(1996)公开;这些参考出全部参考合并于此。这些化合物包括抗血小板药剂(表1)、抗凝血酶药剂(表2)和抗增生药剂(表3)。一些落入这些化合物等级的优选药剂列于表1~3。
表1 抗血小板药剂
化合物 | 作用 |
阿司匹林 | 环氧合酶抑制作用 |
双嘧啶氨醇 | 磷酸二酯酶抑制作用 |
噻氯匹定 | 血小板受体、纤维蛋白原和von Willebrand因子之间的相互阻滞作用 |
C7E3 | 对糖蛋白IIb/IIIa受体的单细胞系的抗体 |
整联蛋白 | 竞争的糖蛋白IIb/IIIa受体抑制剂 |
MK-852,MK-383 | 糖蛋白IIb/IIIa受体抑制剂 |
RO-44-9883 | 糖蛋白IIb/IIIa受体抑制剂 |
表2抗凝血酶药剂
化合物 | 作用 |
肝素 | 抗凝血酶III辅助因子 |
低分子量肝素(LMWH) | 利用抗凝血酶III抑制因子Xa |
R-水蛭素 | 选择的凝血酶抑制 |
黑如洛格(Hirulog) | 综合的直接的凝血酶抑制 |
阿加曲班(Argatroban),艾夫加苗朗(efegatran) | 综合的竞争的凝血酶抑制 |
蜱抗凝血剂肽 | 特定的凝血酶抑制 |
P填塞物 | 不可逆的凝血酶抑制 |
补充的抗血栓形成的物质和配方包括内皮衍生的松弛因子、前列腺素12、血浆酶原活化剂抑制剂、组织型血浆酶原活化剂(tPA),ReoPro:抗血小板糖蛋白IIb/IIIa整联蛋白受体、肝素、共价结合了硫酸葡聚糖和肝素的聚胺、内在移植物用的聚合物涂(STS生物聚合物公司的MEDI-COAT〔医学涂层〕)、聚尿烷脲/肝素、水蛭素/前列腺环素及类似物、纤维蛋白和纤维蛋白肽A、降脂药物如Ω-3脂肪酸和通过蛾蛹血管技术的蛾蛹素(chrysalin)(又名TRAP 508)(该药剂是人体的酶-凝血酶的合成制造的肽部分,造成血凝块和促使细胞/组织修补)。蛾蛹素通过与组织修补中涉及的细胞上的受体的相互作用而摹拟凝血酶的特有属性。
按照本发明的其它抗再狭窄物质包括COR治疗公司的整联蛋白(INTEGRILIN)(eptifibatide)(阻止血小板成凝块)、AVI生物医药公司和移植物科学公司的Resten-NG(神经基因〔NeuGene〕)(C-MYC致肿瘤基因的合成变体)、Abbott实验室公司和生物可兼容物国际PLC公司的BiodivYsio(磷酰胆碱<PC>)、Endovasc公司和Collaborative BioAlliance(协作生物联合)公司的脂质体前列腺素EI、将基因载运到血管平滑肌细胞的腺病毒带菌体(波士顿科学公司和CardioGene(心基因)治疗公司)、Bristol-Myers Squibb公司的TAXOL(帕克里塔克素〔paclitaxel〕)(通过促进组合和抑制微管的分解而防止细胞分裂)以及雷帕霉素或一氧化一氮、其它药物包括酰基鞘氨醇、肉桂氨回酸、丙丁酚、司他丁(statins)、西罗司他唑(cilostazol)和肝素的低分子量变体。
各种化合物被认为可用于控制血管再狭窄和支架内的再狭窄。表3中列举了这些优选的抗增生药剂(如下)。
表3抗增生药剂
化合物 | 作用 |
血管肽素(Angiopeptin) | 抑制IGF-1的生长激素抑制剂类似物 |
西前列烯 | 前列腺环素类似物 |
钙阻滞剂 | 抑制迟钝的钙通道 |
秋水仙素 | 抗增生和抑制移动 |
环孢菌素 | 抑制免疫,抑制细胞内生长信号 |
细胞拉宾(Cytorabine) | 抗肿瘤,DNA综合抑制 |
融合蛋白质 | 限制毒素的生长因子 |
里奥普罗斯特(Lioprost) | 前列腺环素类似物 |
凯他色林(Ketaserine) | 血清素对抗剂 |
去氢可的松 | 类固醇激素 |
唑嘧胺 | 血小板衍生生长因子抑制剂(血栓环氧乙烷-A2和/或PDGF受体对抗剂) |
也已识别可能调节平滑肌细胞(SMC)增生的特定的治疗药剂。因为平滑肌细胞增生与动脉粥样硬化狭窄以及手术后再狭窄有关,所以包括此种药剂可能特别有用。这些药剂不受限制地包括SMC有丝分裂调节剂(如TAXOL、雷帕霉素或酰基鞘氨醇)与用于细胞外的基质生成的刺激素和触发剂如抗FGF和TGF-B1、适应剂、组织抑制剂金属蛋白酶(TIMPs)以及基质金属蛋白酶。
各种化合物处理特定的病理学事件和/或疾病。表4中总结了这些治疗目标化合物中的一些(如下)。
表4特定的治疗目标化合物
病理学事件 | 治疗目标化合物 |
内皮的机能障碍 | 一氧化一氮诱导剂或抗氧化剂 |
内皮损伤 | 给予VEGF、FGF′s |
细胞激活和表型调节 | MEF-2和Gax调节剂;NFKB对抗剂;细胞环抑制剂 |
调节失常的细胞生长 | E2F引诱物;RB突变体;细胞环抑制剂 |
调节失常的脱噬作用 | Bax或CPP 32诱导剂;Bc1-2抑制剂;整联蛋白对抗剂 |
血栓形成 | IIb/IIIa阻滞剂;组织因子抑制剂;抗凝血酶剂 |
斑块破裂 | 金属蛋白酶抑制剂;白细胞粘连阻滞剂 |
异常细胞移动 | 整联蛋白对抗剂;PDGF阻滞剂;血浆酶原活化体抑制剂; |
基质变化 | 金属蛋白酶抑制剂;血浆酶原对抗剂;基质蛋白质交联变更因子 |
结合在本发明的支架材料上的或合并于该材料中的治疗药剂可以按照其在宿主中的作用部位而分类。据信下列药剂将其作用施加在细胞外或在特定的膜受体上。这些包括类皮质激素及其它离子通道阻滞剂、生长因子、抗体、受体阻滞剂、融合毒素、细胞外基质蛋白质、肽或其它生物分子(如激素、脂类、基质金属蛋白酶等)、辐射、抗炎药剂包括胞质分裂素如中间白细胞素-1(IL-1)和肿瘤坏死因子α(TNF-)、γ干扰素以及调节发炎响应的Tranilast。
其它组的药剂对血浆膜施加其影响。这些包括在信号转导级联中涉及的药剂,如联结蛋白质、与膜有关的和胞浆的蛋白质激酶和效应体、酪氨酸激酶、生长因子受体及粘着分子(选择蛋白和整联蛋白)。
一些化合物在胞浆内是活性的,包括(例如)肝素、核糖酶、西托克辛(cytoxins)、抗过敏的低聚核苷酸及分泌带菌体(expressionuectors)。其它治疗途径指向细胞核。这些途径包括基因整合作用、原始致肿瘤基因,特别是那些对细胞分裂、核蛋白、细胞环基因和转录因子重要的途径。
控制再狭窄的基因途径不受限制地包括:对PDGFR-mRNA使用抗过敏的低聚核苷酸;对细胞核抗原C-myb或C-myc致肿瘤基因使用抗过敏的低聚核苷酸(Bauters等人,1997年,《CV(心血管)医学趋势》);使用抗过敏的硫代磷酸盐少脱氧核苷酸(DDN)克服cdk 2激酶(依赖细胞周期蛋白的激酶)来控制血管SMC的细胞环(Morishita等人,1993年,《高血压》);使用VEGF基因(或VEGF本身)来刺激重建创伤治疗如内皮愈合和减少新内膜生长(Asahara等人,1995年);输送一氧化一氮合成酶基时(eNOS)以减少血管SMC增生(Yon Der Leyen等人,1995年,Proc Natl Acad Sci);使用分泌腺病毒的血浆酶原活化质抑制剂-1(PAI-1)来减小血管SMC的移动并由此减小再狭窄(Carmelict等人,1997年,《循环》);刺激阿朴脂蛋白A-1(ApoAl)过分泌来再平衡LDL和HDL的血清水平;使用脱噬作用基因产物来促使细胞死亡(SMC的)和使用细胞顺序的基因产物来调节细胞分裂(肿瘤抑制蛋白p53和Gax同源异形盒基因产物来抑制拉司(ras);p21过分分泌);以及抑制NFKB的激活(如p65)以控制SMC的增生(Autieri等人,1994,Biochem Biophys Res Commun)。
可以用作支架涂层和/或合并在可降解的支架内的储存配方的其它治疗物质包括:用于抑制单核细胞化学顺序补充和粘连、巨噬细胞粘连及相关事件的对ICAM-1的各种抗体(Yasukawa等人,1996年,《循环》);以毒素为基础的各种疗法如控制血管SMC增生的嵌合体的毒素或单体的毒素(Epstein等人,1991年,《循环》);在那些带有大量FGF-2受体的细胞中选择地停止SMC增生的bFGF-萨泡林(saporin)(Chen等人,1995年,《循环》)、苏拉明通过阻止PDGF诱导的和/或有丝分裂原激活的蛋白质激酶(MAPK-AP-1)诱生的发信号而抑制移动和增生(Hu等人,《循环》,1999年);一种化学稳定的前列腺环素类似物(PGl2)贝拉普罗斯特(Beraprost)钠抑制冠状动脉的内膜变厚和管腔变窄(Kurisu等人,《广岛医学科学杂志》,1997年);戊脉安抑制新内膜平滑肌细胞的增生(Brauncr等人,J.Thorac.Cardiovasc、Surg.,1997年)阻滞CD 154或CD 40受体的药剂可以限制动脉粥样硬化的进行(E.Lutgens等人,《自然医学》,1999年);控制剪应力响应的药剂能响应元素或机械应力或应变元或热震基因;以及对SMC和发炎细胞的抗化学吸引剂。
此外或替换地,细胞可以包在一个可降解的微球中,或直接与聚合物或水凝胶混合并用作药物输送工具。活细胞可以用来连续输送药物型分子如细胞分裂素和生长因子。非活细胞也可用作一个有限的或计时的释放系统。按照本发明的这一方面可以使用细胞或任何来源。其次,可以使用当重新水合时保持其活力的保存的或脱水的细胞。可以使用天然的、化学改性的(处理的)和/或基因工程的细胞。
支架的展开
能够利用适合其设计的方法而将支架展开在体内。一种这样的方法是将收缩的支架安装在一个可充气的气囊导管部件上并膨胀该气囊而迫使该支架与体腔接触。当气囊充气时,脉管中的问题物质沿通常垂直于该脉管的壁的方向而受压缩,这随后又使脉管扩张而便于血液在管中流动。冠状动脉的径向膨胀在几个不同的方向发生,并与斑块的性质有关。软的脂肪斑块沉积物被气囊压扁而硬化的沉积物被破碎和分裂而扩大体腔。最好支架能以均匀的方式沿径向膨胀。
或者是,该支架可以安装在一根导管上,当输送通过体腔时导管保持在支架上,然后松脱装置支架并允许后者自行膨胀而接触体腔。在该支架已被经皮引入、经体腔输送而利用该导管安置在一所要位置时,该展开就完成了。该再排成序列的机构可以包括一个可移去的鞘。
今日最常用的支架比希望的更硬。其相对挠曲度示于图14A和14B。未展开/安装的支架的挠曲度示于图14A。所要的偏转试验是按支架测量的ASTM标准所述在室温的盐水中进行的。该S540(2.5×18mm)和S670(3.0×18mm)支架是由Medtronic(医学电子)公司生产的,该TRISTAR(2.5×18mm)是由Guidant公司生产的,该VELOCITY(2.5×13mm)是由J&J公司生产的,而该Nir(2.5×32mm)是由波士顿科学公司销售的。图14A(未展开在一根输送导管上)中所示结果表示试验的其它支架的硬度大到按照本发明制造的支架(MD3)的硬度的两倍以上。已展开(已膨胀)的支架的挠曲度的差别甚至更显著,如图14B中所示。
由于非常小的轮廓、小的收缩直径和大的挠曲度,按照本发明制造的支架能够引导小的或曲折的路径。因此,本发明的小轮廓支架可以用于冠状动脉、颈动脉、血管动脉瘤(当覆盖一鞘时)与周围的动脉和静脉(如肾的、髂骨的、股的、腘的、锁骨下的、主动脉、颅间的等等)。其它非血管用途包括胃肠的、十二脂肠、胆管、食管、尿道、生殖道、气管和呼吸道(如支气管)。这些用途可能需要也可能不需要一个覆盖支架的鞘。
本发明的支架适合于用该技术中已知的常规方法和用经皮的经腔的导管部件来展开。该支架设计用于利用各种原位膨胀机构如可充气气囊或在外加压力时会膨胀的聚合物塞。例如,该支架的管体首先安置成围绕一可充气气囊导管的一部分。内部具有气囊导管的支架做成处于第一收缩直径。该支架和可充气气囊跟随一根在线上的血管成形术导管系统中的预置导线经皮地引入体腔,并用荧光镜追踪,直到气囊部分和相关的支架置于体腔内安置该支架的点处。其后,该气囊充气,而该支架通过该气囊部分从收缩直径膨胀到第二膨胀直径。在该支架已膨胀到所要的最终膨胀直径后,该气囊放气而导管撤回,留下支架在位置中。该支架在输送期间可以覆盖一个可移去的鞘,以保护支架和血管两者。
该膨胀直径是可变的,由体腔的所要膨胀内径决定。因此,支架的受控的膨胀不会造成体腔的破裂。其次,该支架将抵抗缩回,因为锁定机构抵抗径向元件端部上的活动机构内的细长的肋的滑动。因而,膨胀的体腔内的支架将继续向外对着体腔壁施加径向压力,并因此不会从所要位置移开。
虽然已经详细描述了本发明的许多优选实施例及其变化方案,但该技术的专业人员将清楚它们的使用和医学用途的其它变化和方法。因此,应当理解,可以作出对等同物的各种应用、修改和替换而并不偏离本发明的精神和权利要求书的范围。
Claims (35)
1.一种体腔内的可以膨胀的支架,包括:
一个管状部件,包括一个畅通的通腔并具有近端和远端及两端之间限定的纵向长度、一个周边以及一个可以在至少一个第一收缩直径和至少一个第二膨胀直径之间调整的直径,所述管状部件包括:
至少一个包括一系列滑动和锁定的径向元件的模件,其中每个径向元件限定该管状部件的周边的一部分,其中在该第一收缩直径或第二膨胀直径中径向元件本身不重叠;以及
至少一个活动连接机构,该机构允许径向元件从第一收缩直径单向滑动到第二膨胀直径,但阻止从第二膨胀直径沿径向缩回。
2.权利要求1的体腔内的可以膨胀的支架,其特征在于,每个径向元件包括至少一个配置在第一和第二端部之间的细长的肋。
3.权利要求2的体腔内的可以膨胀的支架,其特征在于,组成一个模件的径向元件在具有奇数的细长肋的径向元件和具有偶数的细长肋的径向元件之间进行交替。
4.权利要求3的体腔内的可以膨胀的支架,其特征在于,组成一个模件的径向元件在具有一个细长肋的径向元件和具有两个细长肋的径向元件之间进行交替。
5.权利要求1的体腔内的可以膨胀的支架,其特征在于,该管状部件包括至少两个用至少一个连接元件互相联接的模件。
6.权利要求5的体腔内的可以膨胀的支架,其特征在于,至少一个连接元件是用可降解的材料制成的。
7.权利要求1的体腔内的可以膨胀的支架,其特征在于,还包括一个包围每个模件内至少一个径向元件的框架元件。
8.权利要求7的体腔内的可以膨胀的支架,其特征在于,该管状部件包括至少两个模件,其中这些来自相邻模件的框架部件被联接在一起。
9.权利要求8的体腔内的可以膨胀的支架,其特征在于,这些来自相邻模件的框架元件是通过一个延伸在这些框架元件之间的连接元件而联接的。
10.权利要求8的体腔内的可以膨胀的支架,其特征在于,这些来自相邻模件的框架元件是通过这些框架元件的互连而联接的。
11.权利要求1的体腔内的可以膨胀的支架,其特征在于,随着该管状部件从第一收缩半径调整到第二膨胀半径,一个模件内各径向元件之间的重叠量均保持恒定。
12.权利要求1的体腔内的可以膨胀的支架,其特征在于,该模件内各径向元件之间的重叠量小于约15%。
13.权利要求1的体腔内的可以膨胀的支架,其特征在于,该径向缩回小于约5%。
14.权利要求1的体腔内的可以膨胀的支架,其特征在于,所述管状部件的刚度小于约0.01牛顿力/毫米偏转。
15.权利要求1的体腔内的可以膨胀的支架,其特征在于,所述管状部件提供一个大于约20%的表面积覆盖率。
16.权利要求1的体腔内的可以膨胀的支架,其特征在于,该管状部件至少是部分不透射线的。
17.权利要求1的体腔内的可以膨胀的支架,其特征在于,所述径向元件是基本上用一种加工硬化到约80%至95%之间的材料制成的。
18.权利要求1的体腔内的可以膨胀的支架,其特征在于,这些径向元件是用一种选自包含聚合物、金属、陶瓷及其复合物的组群的材料制成的。
19.权利要求1的体腔内的可以膨胀的支架,其特征在于,这些径向元件是用一种可以降解的材料制成的。
20.权利要求18的体腔内的可以膨胀的支架,其特征在于,所述材料还包括一种生物活性剂。
21.权利要求20的体腔内的可以膨胀的支架,其特征在于,所述材料适合于输送一定量的足以在支架的展开部位处抑制再狭窄的生物活性剂。
22.权利要求20的体腔内的可以膨胀的支架,其特征在于,在支架展开期间当该管状部件从第一收缩直径调整到第二膨胀直径时这些径向元件适合于释放该生物活性剂。
23.权利要求20的体腔内的可以膨胀的支架,其特征在于,该生物活性剂选自包含抗血小板剂、抗凝血酶剂、抗增生剂和消炎药剂的组群。
24.权利要求1的体腔内的可以膨胀的支架,其行征在于,该管状部件还包括一个鞘。
25.权利要求1的体腔内的可以膨胀的支架,其特征在于,包括至少两个模件,其中该第一和第二模件的膨胀直径是不同的。
26.权利要求1的体腔内的可以膨胀的支架,其特征在于,每个活动连接机构在一个径向元件上包括一个槽和一个接头片而在一个相邻的径向元件上包括至少一个可以滑动地接合在该槽中的止动件,其中该接头片适合于接合该至少一个止动件。
27.权利要求26的体腔内的可以膨胀的支架,其特征在于,该至少一个止动件包括一个带倒角的孔。
28.权利要求26的体腔内的可以膨胀的支架,其特征在于,该至少一个活动连接机构还包括一个在该可以滑动地接合的径向元件上的膨胀阻力器件,其中该膨胀阻力器件在膨胀期间阻止通过该槽,直到施加另外的力为止,使得该模件中的径向元件以一种基本上均匀的方式膨胀。
29.权利要求1的体腔内的可以膨胀的支架,其特征在于,该活动连接机构还包括松脱装置,使得起动这种松脱装置便允许这些径向元件从第二膨胀直径滑动回到第一收缩直径。
30.权利要求1的体腔内的可以膨胀的支架,其特征在于,还包括一个带有一活动连接机构的浮动联接元件。
31.一种体腔内的可以膨胀的支架,包括:
一个管状部件,包括一个畅通的通腔和一个可以在至少一第一收缩直径和至少一个第二膨胀直径之间调整的直径,所述管状部件包括:
一系列用一种可降解的材料制成的滑动而锁定的径向元件,其中该系列中的每个径向元件限定该管状部件的周边的一部分,其中径向元件本身不重叠;以及
至少一个活动连接机构,该机构允许径向元件从第一收缩直径单向滑动到第二膨胀直径,但阻止从第二膨胀直径沿径向缩回。
32.权利要求31的体腔内的可以膨胀的支架,其特征在于,该可降解的材料选自包含聚芳基化物(L-酪氨酸衍生的)、无酸聚芳基化物、聚碳酸酯(L-酪氨酸衍生的)、聚(酯酰胺)、聚(富马酸丙脂共乙二酸乙酯)共聚物、聚酐酯、聚酐、聚原酸酮、丝蛋白聚合物、磷酸钙和镁合金的组群。
33.权利要求31的体腔内的可以膨胀的支架,其特征在于,所述可降解的材料还包括至少一种当该材料降解时释放的生物活性剂。
34.权利要求33的体腔内的可以膨胀的支架,其特征在于,该至少一种生物活性剂选自包含抗血小板剂、抗凝血酶剂、抗增生剂和消炎药剂的组群。
35.一种体腔内的可以膨胀的支架,其特征在于,包括一个有一壁和一畅通的通腔的管状部件,所述管状部件包括一系列不会相互重叠的滑动而锁定的径向元件,所述径向元件包括一个允许这些径向元件从第一收缩直径单向滑动到第二膨胀直径的咬合机构,其中当该管状部件处于该第一收缩直径或第二膨胀直径时该管状部件的刚度小于约0.01牛顿力/毫米偏转,而所述壁的厚度小于约0.006英寸。
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- 2001-12-12 CA CA2427270A patent/CA2427270C/en not_active Expired - Fee Related
- 2001-12-12 CN CN018206441A patent/CN1529572B/zh not_active Expired - Fee Related
- 2001-12-12 AU AU3083302A patent/AU3083302A/xx active Pending
- 2001-12-12 JP JP2002549160A patent/JP4242153B2/ja not_active Expired - Fee Related
- 2001-12-12 WO PCT/US2001/048316 patent/WO2002047582A2/en active IP Right Grant
- 2001-12-12 EP EP01991081.9A patent/EP1341481B1/en not_active Expired - Lifetime
- 2001-12-12 RU RU2003111172/14A patent/RU2294716C2/ru not_active IP Right Cessation
-
2003
- 2003-06-03 US US10/452,954 patent/US20030199969A1/en not_active Abandoned
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2005
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2006
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2007
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2008
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Also Published As
Publication number | Publication date |
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CA2427270A1 (en) | 2002-06-20 |
EP1341481A2 (en) | 2003-09-10 |
JP2004515307A (ja) | 2004-05-27 |
US20070061004A1 (en) | 2007-03-15 |
AU2009217389A1 (en) | 2009-10-15 |
WO2002047582A2 (en) | 2002-06-20 |
JP4242153B2 (ja) | 2009-03-18 |
RU2294716C2 (ru) | 2007-03-10 |
WO2002047582A3 (en) | 2002-10-31 |
US7722662B2 (en) | 2010-05-25 |
AU2007203034A1 (en) | 2007-07-19 |
US20030199969A1 (en) | 2003-10-23 |
JP2008200530A (ja) | 2008-09-04 |
AU3083302A (en) | 2002-06-24 |
US6623521B2 (en) | 2003-09-23 |
AU2002230833B2 (en) | 2007-03-29 |
EP1341481B1 (en) | 2015-03-18 |
HK1068245A1 (en) | 2005-04-29 |
CA2427270C (en) | 2010-02-16 |
CN1529572B (zh) | 2010-04-28 |
AU2009217389B2 (en) | 2009-10-29 |
US20010044651A1 (en) | 2001-11-22 |
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