CN101854890A - 具有不透辐射标志物的自膨胀支架以及制造这种支架的方法 - Google Patents
具有不透辐射标志物的自膨胀支架以及制造这种支架的方法 Download PDFInfo
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract
在支架于身体内腔的支架点处的释放过程中,通过近中心收缩环绕的外壳而从自膨胀支架的一端推动自膨胀支架,可将不可接受的大应力施加于支架的部分支柱网。为了将支架设置在身体内腔中,通常装配具有不透辐射标志物于支架的端部环。本发明包括布置所述标志物从而使它们与端部环中没有标志物的部分分配通过端部推动而施加于支架上的应力,因此大应力由端部环中的所有支架的支柱更均等地分配。
Description
技术领域
本发明涉及一种具有附着于其至少一个端部的多个不透辐射标志物的、径向自膨胀的支架,以及制造这种支架的方法。
背景技术
血管支架通常用于各种血管疾病的治疗。利用导管输送系统将它们进行腔内植入以将其推进到支架点,它们在此膨胀以扩张堵塞或变窄的血管。在植入过程中,主要使用X射线成像技术来监视血管中支架的准确位置。为了确保精确定位,支架的良好可见度是至关重要的。这通常通过附着由其射线不透性大于支架材料的材料制成的适当标志物来实现。另外,这些标志物必须足够大以提供良好的X射线造影。为了在输送过程中准确地确定支架的位置,在支架的两端放置该标志物是有利的。
WO-A-2002/015820中公开了一种管状支架,该管状支架具有附着于所选择的围绕其圆周弯折区上的多个不透辐射标志物。该标志物是勺形的,从而在支架处于径向压缩状态时形成几乎完整的标志物材料环,这在腔内输送过程中提供了特别高级别的射线不透性。因此,实现了增加对射线的可见度而不增加该标志物位置处的支架壁厚,并保持了小横截面轮廓和对流体流动的大径向开口。理想地,在上述这种标志物环中保持很小的标志物数量,从而使每个标志物足够大以便即使在支架处于径向膨胀状态时提供足够的可见度。而且,标志物/弯折区接头的数量应该保持最小以便在放置所述支架后降低没有这样一个接头之后标志物在人体中损失的风险。
对于自膨胀支架的情况,利用同轴导管输送系统执行到血管的较窄部分的输送。因此,所述支架通过外壳保持其径向压缩状态。使用外壳内部的同轴圆柱以相对于外壳轴向地移动所述支架。一旦所述支架放置在血管内的理想位置,撤回该外壳,而所述内部圆柱推挤受压缩支架的一端,这加速所述支架从所述输送系统中释放。该过程可施加于诸如WO-A-2002/015820中公开的这样一个支架上,其将重点集中于轴向地突出于支架环的支柱基体轴向端之外的不透辐射标志物上。这个集中于标志物和弯折区之间、从此处由悬臂支撑的接头的重点,已被本发明人视为能够并且应该减少或甚至去除的特征。
本专利申请声明GB 0 717 481.6的优先权。在英国专利局对该英国优先权申请的权利要求所做的检索报告中引用了如下文件:WO2006/047977;DE-U1-20 2004 014 789;WO 2004/028408和EP-A-1433 438。前两份引用文件所公开的是来自同一发明人的相同发明。
WO 2006/047997公开了具有端部环的支架,其将不透辐射标志物材料装入支架金属的接收部件的凹座内。这样,该标志物材料具有暴露的管腔和远离管腔(abluminal)的部分圆柱形的、相对的主表面和相应于围绕标志物在其主表面之间的整个圆圆周缘的接收部件的厚度。该标志物在支架环的圆周方向具有小于其中容纳有该标志物的部分支架的圆周长度的宽度。通过所述容纳部分支撑所有侧面的该标志物从径向位于支架环、标志物的圆锥面部分以及容纳部分外部的位置进入该凹座,所述凹座用来将该标志物引导到容纳部分内部的紧贴地装配的位置。
WO 2004/028408公开的内容与此类似。至于EP-A-1 433 438,其公开了支架上的其他种类的不透辐射标志物,尤其是围绕支架的支柱缠绕的不透辐射材料丝或者围绕支架的支柱卷曲的不透辐射材料套筒。不言而喻,支架在设置该标志物的径向方向局部较厚。
发明内容
本发明的主要目的是提供一种附着有不透辐射标志物的自膨胀支架,其在所述支架从所述输送系统释放过程中提供高度机械稳定性并保持暴露于辐射的良好可见度。这个目的通过具有权利要求1的技术特征的一种自膨胀支架实现。从所述从属权利要求中得到本发明的优选实施方式。
本发明提供一种具有两个端部环以通过同轴导管输送系统输送的自膨胀支架。在所述支架释放过程中推动的所述端部环具有多个分布在其圆周的间隔的弯折区,其中一些承载有不透辐射标志物。本构想是使所有弯折区分担释放应力,而不仅仅是承载不透辐射标志物。一般而言,此处所用的术语“弯折区”是指两个或更多个支柱端连接的区域或者两个或更多个支柱交叉的区域。然而,并不局限于不本解释。很大数量的不同支柱样式用于或至少提议用于管状支架。这些样式中的每一个将具有将一端限定到支架管和允许标志物附着的点。术语“弯折区”定义成包括这些端点。
使所述不透辐射标志物成形,并将其定位在所选择的弯折区,从而使在所述支架释放过程中施加于所述端部环上的所述压缩应力分配在所述标志物和不承载标志物的所述弯折区之间。这样,所述标志物/弯折区接头上的应变达到最小,并降低了诸如断裂或变形的物理损坏的风险。该概念适用于任何支架设计,并允许使用仅小数量的标志物,同时所述支架的稳定性得到保证。标志物的数量保持最小具有巨大优点。第一,具有更少的标志物/弯折区接头降低了标志物断裂或弯曲的危险。自膨胀支架具有极其优良的弹性,但尽管如此,并不是不会变形。随心跳收缩的疲劳性能对血管支架是至关重要的。支架基体局部承受的、超过政府疲劳测试监管协议制订的最大值的任何应力,能够对所述支架的疲劳寿命产生不利影响。既然在支架释放过程中甚至是接头的最轻微的损坏都会缩短支架的使用寿命,这个事实强调健壮支架设计的重要性。而且,标志物全体在支架处于径向压缩状态时形成的环的圆周受支架管自身的圆周限制。这样,使标志物的数量保持很小允许更大的标志物尺寸并因而允许改良处于径向膨胀状态的支架的可见度。
所谓“环形支架”显示了沿其轴向长度布置的、在环形物端部之间互连并具有分布在所述环形物端部圆周的多个弯折区的多个环形物。在一个实施方式中,这些环形物端部中的每一个都比所述支架的端部环包括更多的弯折区。因为径向压缩状态下所述支架在其整个结构中具有同种圆周,所以所述支架的端部环的圆周将与所述环形物端部的圆周相同,尽管所述支架包括更少的弯折区。因此,可增加承载标志物的所述弯折区的圆周范围,这允许附着更大的标志物,且对于上述的可见度是有利的。如果不承载标志物的支架的端部环的弯折区比分布在所述环形物端部圆周中的弯折区具有更小的圆周范围,则可在所述支架的端部环中为所述标志物创建甚至更大的空间。因此,上述布置便于在不改变所述支架环的弯折区的数量的情况下可能增大标志物的尺寸,而这可能影响支架的诸如稳定性和弹性的机械性能。
在另一优选实施方式中给出了在所述支架的端部环中为所述标志物创建更多空间的进一步方法,其中不承载标志物的所述支架的端部环的弯折区比分布在所述环形物端部的圆周中的弯折区具有平行于所述支架长轴的更大的轴向长度。
优选地,所述标志物在粘合于胶接口处的所述弯折区,更优选地,通过焊接连接。此处的焊接形式通过所述标志物的形状和尺寸确定。
在优选实施方式中,承载标志物的弯折区在形状、尺寸或者形状和尺寸两方面都与不承载标志物的弯折区不同。承载标志物的弯折区可以例如具有更小的尺寸从而为所附着的标志物或者特别适于特定焊接类型的形状留下更大的空间(取决于所述标志物的形状和尺寸)。在一个实施方式中,每个弯折区为具有平行于所述支架的长轴的轴向长度的杆(stem)。优选地,承载标志物的所述弯折区杆比不承载标志物的弯折区杆具有更小的长度。该布置允许在相邻的更长的弯折区之间容纳部分标志物(或者甚至是整个标志物)。
优选地,所述标志物和弯折区具有相同的厚度,但是不排除具有更大径向厚度的标志物。一方面,由于应该保持所述支架的小横截面轮廓和对流体流动的大径向开口,增加的标志物厚度超过所述支架的环壁厚度是不理想的。另一方面,所述标志物的射线不透性和机械性能取决于它们的厚度。因此,当暴露于辐射时,标志物太薄将带来很差的对比度,并可能易于变形或者甚至断裂。
在优选实施方式中,每个标志物比不承载标志物的每个弯折区对着端部环圆周的更大的圆弧,这提高了支架端部的可见度。在任何情况下,标志物在圆周方向的宽度通常等于或大于,但不小于所述标志物所附着的所述弯折区的圆周宽度。
许多不同的材料可用于所述支架和不透辐射标志物的制造。优选地,所述支架由镍钛形状记忆合金制成。这种合金为可靠的支架操作提供了所必需的机械性能,即高度的弹性和物理稳定性。所述不透辐射标志物优选地由钽、金或由镍、钛和第三种不透辐射金属制成的三元合金制成。所有这些金属提供了高度的不透射线性。上述支架和标志物材料都是无毒的,并且提供与人体良好的生理兼容性。因为镍钛支架和钽标志物的电化学势类似,对于镍钛支架,钽标志物是特别好的。
在另一优选实施方式中,在所述支架处于径向压缩状态时,所述标志物不能轴向地延伸至不承载标志物的所述弯折区之外。这种布置可例如通过使承载标志物的弯折区比不承载标志物的弯折区更短来实现。优选地,在将所述支架从所述输送系统释放的过程中,所述标志物和不承载标志物的所述弯折区邻接或者物理接触于所述输送系统的推动部分,即同轴内圆柱。在这种构造中,在支架释放过程中施加于端部环上的压缩应力分布在所述标志物和没有标志物的弯折区之间,使得对所述支架造成物理损害的风险达到最小。通过选择小数量的位于所述支架的端部环中的弯折区,并使承载标志物的弯折区足够短,仍然可以维持对于优良的可见度来说足够大的标志物尺寸。
在另一优选实施方式中,在所述支架处于径向压缩状态时,所述标志物的部分边缘放置在所述相邻的弯折区,从而所述输送系统在所述支架释放过程中施加于所述标志物的压缩应力通过所述标志物传递到所述相邻的弯折区。优选地,在此构造中,所述标志物轴向地高于不承载标志物的所述弯折区。在此构造中,可实现标志物尺寸增大,而仍然维持标志物和没有标志物的弯折区之间的外加压力的分布。
所述标志物可通过上面提及的WO-A-2002/015820中所描述的方法焊接于所述弯折区。然而,在一个变型中,所述标志物和弯折区可沿支架的纵轴彼此推进而没有任何相对的径向运动,例如,通过提供各标志物与穿过所述焊接区、彼此面对面的弯折区表面之间的形状配合来实现。所述形状配合通过所述标志物和弯折区上的操作斜坡面实现,各操作斜坡面共同防止沿所述标志物和弯折区的宽度方向的任何相对圆周滑动运动。这样,在所述标志物焊接于所述弯折区之前,所述标志物被引导到与各弯折区圆周对齐的位置。
附图说明
图1是示出了根据第一优选实施方式的、其上附着有不透辐射标志物的支架的激光切割;
图2示出了根据第二优选实施方式的、其上附着有不透辐射标志物的支架的激光切割的一端;
图3示出了根据第二优选实施方式的、处于支架的径向的膨胀状态的端部环的一部分;以及
图4是支架一端的断片的视图,其示出了包括标志物、且位于不承载任何标志物的较长弯折区的侧面的弯折区;
具体实施方式
图1示出了根据第一优选实施方式的、附着有由钽制成的不透辐射标志物14并由镍钛诺制造的径向自膨胀的支架10的激光切割。标志物14焊接于弯折区12’,并一直延伸到不承载标志物12的弯折区。这样,在支架释放过程中通过支架推动器环形物P施加于端部环11上的压缩应力由标志物14和不承载标志物的弯折区12分担,因为邻接推动器P的不仅仅是标志物14,还有不承载标志物14的弯折区12。所述支架包括每个环形物端部的圆周具有14个弯折区12”的四个互连的环形物16。与此相反,端部环11、11’仅具有12个弯折区12、12’。既然弯折区12的圆周范围等于弯折区12”的圆周范围,这使弯折区12’和附着于其上的标志物14的圆周范围(circumferential extent)较大。除此以外,弯折区12的轴向长度大于弯折区12”的轴向长度,这允许较长的标志物。因而,为容纳大的标志物14而特别设计本实施方式从而优化支架10的可见度。
图2示出了根据第二优选实施方式的、其上附着有由钽制造的不透辐射标志物且由镍钛诺制造的支架的激光切割的一端。标志物14焊接于弯折区12’并轴向地高于不承载标志物14的弯折区12。如所见的那样,调整弯折区12’的形状以允许与标志物14的坚固焊接,并使其与弯折区12的形状明显不同。类似于第一优选实施方式,弯折区12’与弯折区12相比而增加的圆周范围通过位于环形物16的端部和端部环11之间的弯折区12、12’、12”的数量不同来帮助实现。而且,在支架10处于径向压缩状态时,弯折区12在其形状构造成容纳T形标志物14的外围部分的顶端处具有凹槽18。这样,尽管在支架10的释放过程中仅有标志物14与输送系统的推动部分P物理接触的事实,施加于标志物上的压缩应力分布在所述标志物和相邻弯折区之间。本构造允许容纳特别大的标志物14且同时维持支架10的稳定。图3示出了根据本实施方式的、处于支架10的径向膨胀状态的端部环11的一部分。在这里,凹槽18更清晰可见。
转到图4,我们在此处看到了位于两个长弯折区12之间并焊接于短弯折区12’上的钽标志物14。该标志物通过两个小桥48、50接合于钽管40。一旦执行了焊接,这些桥48、50便于标志物14以不复杂的方式通过施加外力从钽管40分离。然而,桥48、50不是必需特征,也可以应用将标志物14从钽管40处分离的其他方法。特别地,可使用单个激光器来将标志物14焊接于弯折区12’,以及将标志物14从钽管40处分离。在这种情况下,首先执行焊接步骤,接着在增加激光的输出功率后执行分离步骤。可在单个操作中执行这两个步骤从而改良制造工艺的效率。如果使用上述分离方法,钽管40和标志物14之间的连接剖面可以是任何可想象得到的形状,例如,单个较宽的桥。如上面提及的WO 02/015820中所解释的那样,钽管40和支架的镍钛形状记忆合金管以及弯折区12轴向接近,于是弯折区12和标志物14的面对的表面20和22形成面对面关系,为将它们焊接在一起做好了准备。本领域的读者将会理解,在该通过轴向靠近的接近过程中,两个工件之间不需要任何相对径向运动。
至于标志物14和弯折区12之间的圆周对齐,从图4中可以看到,面对的表面20、22是如何整体地形成配合部分24、26、28、30,其中它们共同将前进的标志物14引导到与弯折区对齐从而在标志物14和两个侧面相接的弯折区12之间分别具有间隙60、62。
面对的表面20、22通过机械的“形状匹配”实现圆周引导功能。当标志物14的鼻部70接近弯折区12’,它可沿面对的表面20滑动,直到它滑过轴向对齐的直边24,此时鼻部70的直边26面对直边24。
然而,到那时候,由位于反向角表面30侧面的、标志物14的面对的表面22中的V形凹座将容纳位于面对的表面20中的反向角表面部分28侧面的、弯折区12’的面对的表面20中的V形顶点。通过表面28和30的邻接来防止表面24和26之间间隔的任何加宽(反之亦然)。这样,接近于弯折区12’并准备好焊接于其上的标志物14不能再相对于弯折区12’圆周地自由运动。恰恰在这种“焊接准备”配置中,标志物14的端面56与侧面相接的弯折区12的端面52和54位于同一平面中,横穿支架的轴线。这样,当支架通过推动器P推动时,推力相等地施加端面52、54和56上。
所例示的实施方式通过实例例示,本领域的读者将会理解,在以下权利要求的范围内,这些特征可孤立于一个实施方式,并可从中提取出来用于其它实施方式中。
Claims (22)
1.一种径向自膨胀支架(10),其具有径向方向的厚度和端部环(11、11’)之间的轴向长度(L),以便通过同轴导管输送系统进行输送,在所述支架从所述输送系统释放的过程中,所述同轴导管输送系统的一部分推动所述支架的一端,而从所述支架的远离管腔表面周围收回外壳,于是所述支架从径向压缩状态膨胀成径向膨胀状态,
待推动的所述端部环(11)具有圆周,多个间隔的弯折区(12)分布在所述圆周中,所选择的弯折区(12’)承载不透辐射标志物(14),
其特征在于:
所述标志物成形,并位于所选择的弯折区上,从而在所述支架释放过程中使施加于所述端部环上的压缩应力分配在所述标志物和不承载标志物的所述弯折区之间。
2.如权利要求1所述的支架,其中,所述支架包括沿其轴向长度布置的多个环形物(16),所述环形物在环形物端部间互连并具有分布在所述环形物端部的圆周中的多个弯折区(12”),每个所述环形物端部比所述支架的端部环包括更多的弯折区。
3.如权利要求2所述的支架,其中,不承载标志物的所述支架的端部环的弯折区比分布在所述环形物端部的圆周中的弯折区具有更大的平行于所述支架的长轴的轴向长度。
4.如权利要求2或3所述的支架,其中,不承载标志物的所述支架的端部环的弯折区比分布在所述环形物端部的圆周中的弯折区具有更小的圆周范围。
5.如前述权利要求中的任一项所述的支架,其中,所述标志物在胶接口粘合于所述弯折区。
6.如权利要求1至4中的任一项所述的支架,其中,所述标志物通过焊接附着于所述弯折区。
7.如前述权利要求中的任一项所述的支架,其中,承载标志物的所述弯折区与不承载标志物的所述弯折区具有不同的形状。
8.如前述权利要求中的任一项所述的支架,其中,承载标志物的所述弯折区与不承载标志物的所述弯折区具有不同的尺寸。
9.如前述权利要求中的任一项所述的支架,其中,每个弯折区为具有平行于所述支架的长轴的轴向长度的杆,其中,承载标志物的所述弯折区杆比不承载标志物的所述弯折区杆具有更小的长度。
10.如前述权利要求中的任一项所述的支架,其中,所述标志物和所述弯折区具有相同的厚度。
11.如前述权利要求中的任一项所述的支架,其中,每个标志物比不承载标志物的每个弯折区对着所述端部环的圆周的更大的弧。
12.如前述权利要求中的任一项所述的支架,其中,所述支架由镍钛形状记忆合金制成。
13.如前述权利要求中的任一项所述的支架,其中,所述不透辐射标志物由钽、金或由镍、钛和第三种不透辐射金属制成的三元合金制成。
14.如前述权利要求中的任一项所述的支架,其中,在所述支架的径向压缩状态下,所述标志物不轴向地延伸至不承载标志物的所述弯折区之外。
15.如前述权利要求中的任一项所述的支架,其中,在所述支架的径向压缩状态下,在所述支架从所述输送系统释放的过程中,所述标志物和不承载标志物的所述弯折区都暴露于所述支架的端部环,以直接接收来自所述输送系统的推动部分的推力。
16.如前述权利要求中的任一项所述的支架,其中,在所述支架的径向压缩状态下,所述标志物的外围部分放置在相邻的弯折区上,从而使由所述输送系统在所述支架的释放过程中施加于所述标志物上的压缩应力通过所述标志物传递到所述相邻的弯折区。
17.如权利要求16所述的支架,其中,所述标志物轴向地高于不承载标志物的所述弯折区。
18.如前述权利要求中的任一项所述的支架,所述支架包括延伸至承载不透辐射标志物的每个弯折区的整个宽度并且位于所述弯折区与所述标志物之间的焊接区。
19.一种将不透辐射标志物固定于径向自膨胀支架的弯折区的方法,其中,所述标志物推进到相对于所述弯折区的固定位置内,然后在所述弯折区和所述标志物之间的焊接区焊接于所述弯折区,
其特征在于:
所述标志物和弯折区到所述固定位置的相对运动,不使元件相对于所述支架的纵向轴线、在径向方向运动。
20.如权利要求19所述的方法,其中,所述标志物和所述弯折区显示了穿过所述焊接区面向彼此的各个面对的表面,所述面对的表面包括一旦所述标志物处于所述固定位置中则禁止相对圆周滑动运动的机械形状配合。
21.如权利要求20所述的方法,其中,当所述标志物轴向地接近所述弯折区时,通过相配合的所述标志物和所述弯折区上的斜坡面设置所述机械形状配合,以将所述标志物和所述弯折区引导成在所述焊接区内环绕地排列配置,以备将所述标志物和弯折区焊接在一起。
22.一种支架输送系统,其承载如权利要求1至18中的任一项所述的支架或通过如权利要求19至21中的任一项所述的处理制成的支架,该系统包括位于所述支架一端、与所述标志物和不承载标志物的所述弯折区二者邻接的支架推动器。
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- 2008-09-05 WO PCT/EP2008/061775 patent/WO2009030748A2/en active Application Filing
- 2008-09-05 EA EA201000442A patent/EA201000442A1/ru unknown
- 2008-09-05 US US12/676,584 patent/US8721709B2/en active Active
- 2008-09-05 JP JP2010523512A patent/JP5530357B2/ja active Active
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2014
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN104918585A (zh) * | 2012-10-25 | 2015-09-16 | 动脉再造技术股份有限公司 | 用于生物可再吸收支架的不透射线的标志物 |
CN104918585B (zh) * | 2012-10-25 | 2016-10-12 | 动脉再造技术股份有限公司 | 用于生物可再吸收支架的不透射线的标志物 |
CN111329556A (zh) * | 2016-02-12 | 2020-06-26 | 柯惠有限合伙公司 | 脉管装置的标记物附连 |
CN111329556B (zh) * | 2016-02-12 | 2023-03-28 | 柯惠有限合伙公司 | 脉管装置的标记物附连 |
Also Published As
Publication number | Publication date |
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WO2009030748A3 (en) | 2009-06-18 |
US20100191321A1 (en) | 2010-07-29 |
JP2010537755A (ja) | 2010-12-09 |
US20140239050A1 (en) | 2014-08-28 |
GB0717481D0 (en) | 2007-10-17 |
US8721709B2 (en) | 2014-05-13 |
CA2695153A1 (en) | 2009-03-12 |
CA2695153C (en) | 2016-04-19 |
EA201000442A1 (ru) | 2010-08-30 |
US10016291B2 (en) | 2018-07-10 |
CN101854890B (zh) | 2013-07-24 |
JP5530357B2 (ja) | 2014-06-25 |
WO2009030748A2 (en) | 2009-03-12 |
EP2178471A2 (en) | 2010-04-28 |
ATE520374T1 (de) | 2011-09-15 |
EP2178471B1 (en) | 2011-08-17 |
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