CN102065779B - 用于定位可脱卸植入物的脱卸区域的系统和方法 - Google Patents
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Abstract
一种用于快速地脱卸植入物以及用于定位可脱卸植入物的脱卸区域的系统和方法。随着传感器从处于微导管内部行进到暴露于脉管系统,该传感器确定局部环境中的突然变化。传感器可为温度传感器、超声传感器、压力传感器等。如果可脱卸植入物组件使用了加热器线圈来脱卸植入物,则加热器线圈也可用作传感器。另外,如果随着植入物退出微导管和改变形状可检测到电阻抗的改变,则植入物自身也可被用作传感器。
Description
相关申请
本申请要求2007年12月21日递交的标题为“System and Methodfor Locating Detachment Zone of a Detachable Implant”的美国临时申请61/016154的优先权,将该美国临时申请通过引用全部并入本文。本申请还通过引用并入了:2004年8月25日递交的标题为“ThermalDetachment System For Implantable Devices”的美国临时申请60/604671;2005年5月27日递交的标题为“Thermal Detachment SystemFor Implantable Devices”的美国临时申请60/685342;2005年8月25日递交的标题为“Thermal Detachment System For Implantable Devices”的美国专利申请11/212830;2007年12月21日递交的标题为“Methodof Detecting Implant Detachment”的美国临时申请61/016180。
技术领域
本发明涉及用于将植入物装置输送到病人体内的目标部位的系统和方法。本发明还涉及用于检测被输送植入物装置的脱卸区域位置的系统和方法。
背景技术
通过微创手段输送可植入治疗装置在许多临床表现中已经被证明是值得期望的。例如,血管栓塞已经被用于控制血管流血,以堵塞住供应到肿瘤的血液、堵塞输卵管以及堵塞血管瘤,特别是颅内动脉瘤。近年来,用于治疗动脉瘤的血管栓塞已经受到重视。作为另一示例,使用诸如支架等的网格或台架装置来打开阻塞的血管或保持栓塞线圈也已经受到重视。
在现有技术中已经采用了几种不同的治疗方式用于配置植入物装置。例如,在现有技术中已经描述了用于植入物装置的许多可重定位的脱卸系统,包括授予Guglielmi等的美国专利5,895,385和授予Geremia等的美国专利5,108,407,其内容通过引用合并于此。在例如授予Gandhi等的美国专利6,500,149和授予Handa等的美国专利4,346,712中(将这两份文献的内容通过引用并入本文)公开的一些系统描述了使用加热器来脱卸和部署植入物装置。
一些经皮输送的可脱卸植入系统(例如,用于将堵塞线圈输送到动脉瘤的那些可脱卸植入系统)包括被临时附接到微导管内的推进器机构的可脱卸植入物。推进器机构被用于将植入物从微导管的远端推出。一旦植入物已经被推到相对于微导管的期望位置(在这里称为可脱卸区域),则采用脱卸机构使该植入物从推进器上脱卸下来。因为植入物可能被挂在导管端部并且随后部署在身体中不期望的位置,所以非常重要的是,不要在到达脱卸区域之前使植入物脱卸。
典型地,为了确定植入物是否已经相对于微导管被推进到脱卸区域,射线不透标识器被用在微导管上并且用在推进器、植入物中的一个或二者上。因此,当植入物被推进器推动时,操作者使用射线不透标识器监测微导管和植入物的相对位置。监测射线不透标识器的位置需要在该过程期间使用X射线装置。使用X射线成像装置增加了成本,使该过程复杂化,并且在环绕病人周围的区域中增加了另一占用空间的器械。另外,由于植入物的线圈特征,到达射线不透标识器的视野可能被线圈挡住。
发明内容
本发明是一种用于将诸如线圈、支架、过滤器等的可植入装置定位和部署在包括但不限于血管、输卵管、诸如瘘管和动脉瘤这样的畸形体、心脏缺陷(例如左心耳附件和间隔部缺口)和其它管腔器官的身体腔室中的植入物输送和脱卸系统。
该系统包括植入物、输送导管(广义上指推进器或输送推进器)、将植入物联接到推进器的可脱卸接头、发热设备(广义上指加热器)和向加热器供能的电源。
在本发明一方面,通过使用栓系件、带、丝、线、纤丝、纤维等将植入物联接到推进器。这在广义上都称为栓系件。栓系件可为单纤丝、棒、条带、中空管等形式。很多材料都可用于将植入物可脱卸地接合到推进器。一类材料为聚合物,例如聚烯烃、聚烯烃弹性体(例如由Dow研制并以商标名Engage销售的或由Exxon研制并以商标名Affinity销售的聚烯烃弹性体)、聚乙烯、聚酯(PET)、聚酰胺(尼龙)、聚亚胺酯、聚丙烯、诸如PEBAX或Hytrel的嵌段共聚物,和乙烯-乙烯醇(EVA);或者橡胶材料,例如硅树脂、乳胶和科腾聚合物(Kraton)。在一些情况下,聚合物还可通过辐射被交联,以操纵其抗拉强度和熔化温度。另一类材料为金属,例如镍钛合金(镍钛诺)、金、以及钢。材料的选择依赖于材料保存势能的能力、熔化或软化的温度、用于脱卸的功率和身体治疗部位。栓系件可通过焊接、打结、钎焊、粘接剂结合或其它本领域已知的方法被接合到植入物和/或推进器。在植入物为线圈的一个实施例中,栓系件可穿过线圈的内腔,被附接到线圈的远端。这种设计不仅将植入物接合到推进器,而且在不使用次级拉伸阻力构件的情况下向线圈施加拉伸阻力。在植入物为线圈、支架或过滤器的其它实施例中,栓系件被附接到植入物的近端。
在本发明另一方面,将植入物可脱卸地联接到推进器的栓系件作为保存(势能)能量的容器,该能量在脱卸期间被释放。这有利地减少了用于脱卸植入物所需的时间和能量,因为其允许应用不必完全熔化材料的热来使栓系件切断。保存的能量还可在植入物上施加力,该力推动植入物远离输送导管。这种分离趋于使系统更可靠,因为其可防止栓系件在脱卸之后重新固化并保持住植入物。可以以若干种方法施加保存的能量。在一个实施例中,弹簧可布置在植入物和推进器之间。当通过将栓系件的一端接合到推进器或植入物中任何一个、拉拽栓系件的自由端直到弹簧至少被部分压缩、随后将栓系件的自由端附着到推进器或植入物中的另外一个,从而将植入物附接到推进器时,该弹簧被压缩。因为栓系件的两端都被约束,所以以栓系件上的张力(或弹簧中的压缩)形式的势能被保存在系统中。在另一实施例中,栓系件的一端如之前的实施例那样被固定,随后通过以预定的力或位移拉拽栓系件的自由端,使栓系件被布置为具有张力。当栓系件的自由端随后被附着时,栓系件材料自身的延长会保存能量。
在本发明另一方面,加热器布置在推进器上或者推进器内部,典型地,但不是必须地,靠近推进器的远端。例如,可以通过钎焊、焊接、粘接结合、机械结合或本领域已知的其它技术,将加热器附接到推进器。加热器可为卷绕线圈、热管、中空管、带、海波管(hypotube)、实心棒、环形线圈,或类似形状。加热器可由各种材料形成,例如钢、铬钴合金、铂、银、金、钽、钨、锰铜(mangalin)、可从加利福尼亚Fine Wire公司获得的商标名为Stable Ohm的铬镍合金、导电聚合物等。栓系件被布置为接近加热器。栓系件可穿过中空或线圈型加热器的管腔,或者可被围绕加热器卷绕。尽管栓系件可被布置为直接接触加热器,但这不是必须的。为了易于组装,栓系件可被布置为接近但实际上不接触加热器。
输送导管或推进器是伸长构件,其远端和近端适于允许将植入物操纵到治疗部位。推进器包括核心芯棒和一个或多个电引线,以向加热器供电。推进器可沿着长度在尺寸和/或刚性上逐渐减小,其远端通常比近端更具柔性。在一个实施例中,推进器适于被可伸缩地布置在输送管道中,例如导向导管或微导管。在另一实施例中,推进器包括内管腔,以允许通过引导线来操纵推进器。在又一实施例中,推进器能够被直接操纵到治疗部位,而不需要次级装置。推进器可具有通过荧光可见的射线不透标识系统,这允许其与微导管或其它附属装置上的射线不透标识器结合使用。
在本发明另一方面,核心芯棒的形式为实心轴或中空轴、线、管、海波管、线圈、条带或其组合。核心芯棒可由塑料材料制成,例如PEEK、丙烯酸、聚酰胺、聚酰亚胺、特氟纶、丙烯酸、聚酯、诸如PEBAX嵌段共聚物,等等。(一个或多个)塑料构件可被选择性地通过由金属、玻璃、碳纤维、编织物、线圈等制成的加强纤维或线而使之沿长度变硬。可替代地,或者与塑料部件相结合,诸如不锈钢、钨、铬钴合金、银、铜、金、铂、钛、镍钛合金(镍钛诺)等的金属材料可被用于形成核心芯棒。可替代地,或者与塑料和/或金属部件相结合,诸如玻璃、光纤、锆等的陶瓷材料可用于形成核心芯棒。核心芯棒还可包括复合材料。在一个实施例中,核心芯棒包括诸如铂或钽这样的射线不透材料的内核和诸如钢或铬钴合金这样的抗扭绞材料的外部覆盖物。通过选择性地改变内核的厚度,可在推进器中提供射线不透标识,而不需要次级标识器。在另一实施例中,具有诸如抗扭绞和/或压缩强度这样的期望材料特性的核心材料(例如不锈钢)被例如铜、铝、金或银这样的低电阻的材料覆盖(例如通过电镀、拉拔或本领域已知的类似方法),以增强其导电性,从而允许核心芯棒被用作导电体。在另一实施例中,具有例如核磁共振成像兼容性这样的期望特性的核心材料(例如,玻璃或光纤),由诸如PEBAX或聚酰亚胺的塑料材料覆盖,以防止玻璃破裂或扭绞。
在本发明另一方面,加热器被附接到推进器,随后一个或多个导电体被附接到加热器。在一个实施例中,两根导线延伸了基本上推进器的长度,并且在推进器的远端附近被联接到加热器,而在推进器的近端附近被联接到电连接器。在另一实施例中,一根导线延伸了基本上推进器的长度,而核心芯棒自身由导电材料形成,或者涂覆有导电材料,从而作为第二电引线。线和芯棒在远端附近被联接到加热器,而在推进器的近端附近被联接到一个或多个连接器。在另一实施例中,双极性导体被联接到加热器,并且被用于与射频(RF)能量结合,以向加热器供电。在任何一个实施例中,(一个或多个)导体可与核心芯棒平行地延伸,或者可穿过基本为中空的核心芯棒(例如,海波管)的内管腔。
在本发明另一方面,电和/或热绝缘覆盖物或套管可放置在加热器上。套管可由绝缘材料制成,例如聚酯(PET)、特氟纶、嵌段共聚物、硅树脂、聚酰亚胺、聚酰胺,等等。
在本发明另一方面,导电体被布置在推进器的近端附近,使得加热器通过导体能够被电连接到电源。在一个实施例中,连接器为插头的形式,具有一个或多个插脚或插孔。在另一实施例中,(一个或多个)连接器为能够与夹子型连接器连接的管、插销、或薄片。在另一实施例中,(一个或多个)连接器为适于与外部电源匹配的管、插销、或薄片。
在本发明另一方面,推进器连接到外部电源,使得加热器被电联接到电源。电源可来自(一个或多个)电池,或者可通过壁插口连接到电网。电源供给以下形式的电流:直流(DC)形式的电流;具有高频或低频的交流(AC)、调制的直流或射频(RF)形式的电流。电源可为在无菌区域外工作的控制箱,或者可为适于在无菌区域内工作的手持装置。电源可为一次性的、可再充电的,或者可以是采用一次性或可再充电电池从而能够重复使用的。
在本发明另一方面,电源可包括辅助使用者进行脱卸的电路。在一个实施例中,该电路检测植入物的脱卸,并且当脱卸已经发生时向使用者提供信号。在另一实施例中,该电路包括计时器,其在已经经过了预设时间段时向使用者提供信号。在另一实施例中,电路监测脱卸的数量,并且当已经执行了预设数量的脱卸时,提供信号或者执行例如锁定系统的操作。在另一实施例中,电路包括反馈环路,其监测尝试脱卸的次数,并且增加电流、电压、和/或脱卸时间,以增加脱卸成功的可能性。
在本发明另一方面,系统的结构允许极短的脱卸时间。在一个实施例中,脱卸时间小于1秒。
在本发明另一方面,系统的结构使脱卸期间装置的表面温度最小化。在一个实施例中,脱卸期间在加热器处的表面温度在50℃以下。在另一实施例中,脱卸期间在加热器处的表面温度在42℃以下。
本发明还提供一种方法和系统,用于当可脱卸线圈退出微导管的远处末端时检测可脱卸线圈的脱卸区域的位置,而不需要使用射线不透标识器。各种传感技术均被用于检测各种对应参数中由于微导管内部和暴露于身体目标部位之间的环境差异而导致的变化。
在本发明另一方面,温度传感器被用于检测当传感器退出微导管时温度的变化。该温度的变化指示了可脱卸植入物位于期望的脱卸区域中。
在本发明另一方面,压力传感器被用于检测当传感器退出微导管时压力的变化。该压力的变化指示了可脱卸植入物位于期望的脱卸区域中。
在本发明另一方面,超声传感器被用于检测当传感器退出微导管时的环境空间的变化。当在微导管内时,超声传感器检测到微导管内壁的距离。当在微导管外部时,超声传感器检测到达血管管腔或动脉瘤内壁的增加的距离。因此,距离的变化指示了可脱卸植入物位于期望的脱卸区域中。
在本发明又一方面,可脱卸线圈被用作检测机构。在被导引到目标部位期间,线圈以直的配置容纳在微导管内。当线圈被推出微导管时,其恢复到弯曲配置。如果电流通过线圈,那么电流流动通过线圈的阻抗在线圈弯曲时改变。这种阻抗的变化被用作检测机制。
在考虑下面的附图和详细说明之后,本发明的这些和其它方面和特征将变得清楚。
附图说明
图1示出了根据本发明的脱卸系统的第一实施例的剖切侧视图;
图2示出了根据本发明的脱卸系统的第二实施例的剖切侧视图;
图3A示出了根据本发明的示例性直流信号电流;
图3B示出了根据本发明的示例性交流信号电流;
图4示出了根据本发明的脱卸系统的第三实施例的剖切侧视图;
图5示出了根据本发明的示例性的作为时间的函数的脱卸系统表面的温度数据;
图6示出了根据本发明的脱卸系统的电连接器的剖切侧视图;
图7示出了根据本发明的脱卸系统的射线不透层的剖切侧视图;
图8示出了根据本发明的包括支架的脱卸系统的剖切侧视图;
图9示出了根据本发明的输送系统的局部分解透视图;
图10示出了根据本发明的脱卸系统的电连接器的剖切侧视图。
具体实施方式
转到图1,其示出了本发明的脱卸系统100,具体地示出了脱卸系统100的远端部分。脱卸系统100包括优选为柔性的推进器102。推进器102被配置为用于将植入物装置112推入病人的身体和在病人的身体内推动植入物装置112,具体地,是将植入物装置112推入目标腔部位,用于植入物装置112的输送和植入。可能的目标腔部位包括但不限于诸如动脉瘤和瘘管等的血管和血管部位、诸如左心耳附件等的心脏缺口和缺陷,以及诸如输卵管等的其它管腔器官。
抗拉伸的栓系件104将植入物112可脱卸地联接到推进器102。在该示例中,栓系件104为粘合到推进器102的塑料管。基本为实心的圆柱也可以是栓系件104的一种设计选择。抗拉伸的栓系件104至少部分地延伸通过植入物装置112的内部管腔。
在靠近推进器102的远端处,加热器106被布置为接近抗拉伸的栓系件104。加热器106可包绕在抗拉伸的栓系件104周围,使得加热器106被暴露或以其它方式与血液或环境直接接触,或者可替代地,可通过套管、护套、环氧树脂、粘接剂等与血液或环境隔离。推进器102包括一对电线,正极电线108和负极电线110。线108和110通过诸如焊接或钎焊等任何适合的方式被联接到加热器106。
电线108、110能够联接到电源(未示出)。如所示那样,负极电线110被联接到加热器106的远端,正极电线108被联接到加热器106的近端。在另一实施例中,该配置可相反,即,负极电线110被联接到加热器106的近端,正极电线108被联接到加热器106的远端。
电能从电线108、110施加到加热器106上,以使加热器106近端的栓系件104的一部分断开。加热器106不需要直接接触栓系件104。加热器106只要足够接近栓系件104,使得加热器106产生的热导致栓系件104断开便可。激活加热器106的结果是,抗拉伸的栓系件104中大致远离加热器106且位于植入物装置112的管腔中的部分与植入物装置112一起从推进器102释放。
如所示那样,植入物装置112为栓塞线圈。适于用作植入物装置112的栓塞线圈可包括被形成为螺旋微线圈的具有适合长度的线。该线圈可由生物相容材料形成,包括铂、铑、钯、钨、金、银、钽、和这些金属的各种合金,以及各种手术等级的不锈钢。具体的材料包括已知为铂479(92%的铂,8%的钨,从可纽约Mount Vernon的Sigmund Cohn获得)的铂/钨合金和镍/钛合金(例如已知为镍钛诺的镍/钛合金)。
对于形成线圈有利的另一材料为包括高弹性金属和高射线不透金属的双金属线。这种双金属线还可抵抗永久变形。这种双金属线的示例为包括镍钛诺外层和纯参考等级铂的内核的产品,其可从纽约MountVernon的Sigmund Cohn和马萨诸塞州Shrewsbury的Anomet Products获得。
共同转让的美国专利6,605,101提供了对适于用作植入物装置112的栓塞线圈的进一步的描述,包括具有主要和次要配置的线圈,其中次要配置使在部署之后线圈的不期望的压缩程度最小。美国专利6,605,101的公开内容通过引用完全合并于此。并且,可任选的是,植入物装置112可被涂覆或覆盖有本领域已知的水凝胶或生物活性涂层。
线圈类型的植入物装置112抵抗解旋,这是因为延伸通过植入物装置112的管腔的抗拉伸的栓系件104比植入物装置112自身实质上需要更大的力以便塑性变形。因此,在植入物装置112可能因任何原因解旋的情况下,抗拉伸的栓系件104辅助防止植入物装置112解旋。
在组装期间,势能可保存在装置中,以利于脱卸。在一个实施例中,可任选的弹簧116被放置在加热器106和植入物装置112之间。该弹簧在组装期间被压缩,栓系件104的远端可被系或联接到植入物装置112的远端,或者可通过熔化或其它方式形成在防止损伤的远端114中。
在一个实施例中,抗拉伸的栓系件104由诸如聚烯烃弹性体、聚乙烯或聚丙烯的材料形成。栓系件104的一端被附接到推进器102,栓系件104的自由端被拉拽穿过植入物112,其中植入物112的近端与加热器106(如果没有弹簧116)齐平或与压缩的弹簧116齐平。预先设定的力或位移被用于预先张紧栓系件104,因此在栓系件104内的轴向(即与推进器102的长轴共线或平行)取向上保存能量。力或位移取决于栓系件的材料属性、栓系件104的长度(其自身取决于栓系件在推进器上的联接点和植入物的长度)。通常该力在栓系件材料的弹性极限以下,但足以使栓系件在被施加热时使其快速断开。在将要被部署的植入物是颅内线圈的一个优选实施例中,栓系件的直径在大约0.001至0.007英寸的范围内。当然,必要时,栓系件的尺寸能够变化以适应其它植入物的不同类型和尺寸。
转到图2,其示出根据本发明的脱卸系统的另一实施例,脱卸系统200。脱卸系统200与脱卸系统100具有一些共同的元件。例如,在脱卸系统100中可用作植入物装置112的同样的装置也可用作脱卸系统200的植入物装置112。这些元件还包括例如各种栓塞微线圈和线圈。植入物装置112在前面已经关于脱卸系统100进行了描述。对于植入物装置112,相同的附图标记被用于标识可对应于脱卸系统200的元件/部件的脱卸系统100的其它元件/部件。在脱卸系统100的说明中所参照的对这些元件的说明,同样也应用于脱卸系统200中的这些共有元件。
对于脱卸系统200,内部加热元件206被用于使抗拉伸的管104的一部分和相关联的植入物装置112与脱卸系统200分离。脱卸系统200包括具有核心芯棒218的输送推进器202。脱卸系统200进一步包括延伸通过输送推进器202的管腔的正极电线208和负极电线210。
为了形成内部加热元件206,正极电线208和负极电线210可被联接到输送推进器202的核心芯棒218。优选地,电线208、210被联接到核心芯棒218的远端部分。
在一个实施例中,正极电线208被联接到核心线218上的第一远端位置,负极电线210被联接到核心线218上的第二远端位置,第二远端位置接近第一远端位置。在另一实施例中,该配置相反,即,正极电线208被联接到第二远端位置,负极电线210被联接到核心线218上的第一远端位置。当正极电线208和负极电线210被联接到核心芯棒218的远端部分时,核心芯棒218的远端部分以及电线208、210一起形成电路,该电路即为内部加热元件206。
当电流从联接到正极电线208和负极电线210的电源(未示出)被施加时,加热器206的温度增加。如果要求或期望温度有较大增加/具有更高热度时,诸如铂或钨这样的相对高阻抗的材料可被联接到核心芯棒218的远端,以增加核心芯棒218的阻抗。结果是,当电流施加到加热器206时,产生比低阻抗材料更高的温度增量。联接到核心芯棒218的远端的附加的相对高阻抗的材料可以为任何适合的形式,例如,实心的线、线圈或上述任何其它形状或材料。
因为加热器206位于管形栓系件104的管腔中,因此加热器206与病人的身体隔离。结果是,减少了由于加热器206的加热而对周围身体组织造成意外损伤的可能性。
当电流施加到由核心芯棒218形成的加热器206时,正极电线208、负极电线210、加热器206的温度增加。结果是,抗拉伸的栓系件104中与加热器206接近的部分断开,且与联接到栓系件104的植入物装置112一起从脱卸系统200中脱卸。
在脱卸系统200的一个实施例中,抗拉伸的栓系件104的近端(或者联接到抗拉伸的栓系件104的近端的较大管(未示出)的远端)可扩张,以解决尺寸的约束和便利于脱卸系统200的组装。
以与脱卸系统100类似的方式,例如通过可任选的可压缩弹簧116或通过前述的那样在组装期间预先张紧栓系件104,能量可被保存在系统中。当存在能量时,在植入物装置112被部署时,保存在系统中的势能的释放能够操作以施加额外的压力,从而使植入物装置112以及抗拉伸的栓系件104中与植入物装置112联接的部分与加热器206分离。这有利地减小了所需的脱卸时间和导致栓系件104断开和断裂所需的温度。
与脱卸系统100相同,脱卸系统200的抗拉伸的栓系件104的远端可被系到或联接到植入物装置112的远端,或者通过熔化或其它方式被形成在防止损伤的远端114中。
图4示出了脱卸系统300的另一优选实施例。在很多方面,脱卸系统300与图2所示的脱卸系统200和图1所示的脱卸系统100类似。例如,脱卸系统300包括输送推进器301,输送推进器301包括使植入物装置302脱卸的加热器306。脱卸系统300还利用栓系件310以便将植入物装置302联接到输送装置301。
在图4的剖切视图中,可以看到输送推进器301的远端具有被电联接到电线308和309的线圈形加热器306。这些线308、309布置在输送推进器301中,在输送推进器301的近端退出,并且联接到电源(未示出)。栓系件310布置为接近加热器306,具有被固定在输送推进器301内的近端和联接到植入物装置302的远端。当电流通过线308和309被施加时,加热器306的温度增加,直到栓系件310断裂,释放植入物装置302。
为了减小从加热器306到病人的周围组织的热传递和提供电绝缘,绝缘覆盖物304至少包括在输送推进器301的外表面的远端周围。随着覆盖物304的厚度增加,热绝缘特性也增加。然而,增加的厚度可导致输送推进器301的刚性增加和具有更大的直径,而这可能会增加执行输送过程的困难。因此,覆盖物304被设计为具有足以提供热绝缘特性但不过分增加其刚性的厚度。
为了加强栓系件310与植入物装置302的附接,植入物装置302可包括套环构件322,该套环构件322在焊点318处被焊接到植入物装置302,并且尺寸被设计为装配到输送推进器301的外部加强周界312内。栓系件310系在植入物装置302的近端周围,以形成结316。进一步的加强由布置在结316周围的粘接剂314提供,以防止松开或其它不希望的分开。
以与脱卸系统100和200类似的方式,例如通过可任选的可压缩弹簧(类似于图1中的可压缩弹簧116,但图4中未示出)或通过在组装期间轴向地预先张紧栓系件104,能量可保存在系统中。在本实施例中,栓系件310的一端被附接到植入物装置302的近端附近,如前所述的那样。栓系件310的自由端穿过输送推进器301的远端部分,直到其达到输送推进器301的出口点(未示出)。通过例如在栓系件310的自由端施加预定的力或者将拉紧的(taunt)栓系件310移动预定位移,而将张紧力施加到栓系件310上,从而使能量以弹性变形的方式被保存在栓系件材料中。栓系件310的自由端随后通过例如打结、应用粘接剂或本领域已知的类似方法被接合到输送推进器301。
当存在能量时,在植入物装置302被部署时,保存在系统中的势能的释放能够操作以施加额外的压力,从而使植入物装置302和栓系件310中与植入物装置302联接的部分与加热器306分离。这有利地减小了所需的脱卸时间和导致栓系件310断开和断裂所需的温度。
本发明还提供了使用诸如脱卸系统100、200或300这样的脱卸系统的方法。下面的示例涉及到将脱卸系统100、200或300用于阻塞脑动脉瘤的用途。然而,应该认识到,修改脱卸系统100、200或300及其部件的尺寸和/或修改植入物装置112、302的配置将允许脱卸系统100、200或300用于治疗身体中各种其它的畸形体。
在该具体示例中,脱卸系统100、200或300的输送推进器102、202或301的直径可为约0.010英寸至0.030英寸。联接到输送推进器102、202或301的远端附近和联接到植入物装置112、302的栓系件104、310的直径可为0.0002英寸至0.020英寸。可为线圈的植入物装置112、302的直径可为约0.005英寸至0.020英寸,并且可由0.0005英寸至0.005英寸的线缠绕而成。
如果势能被保存在脱卸系统100、200或300中,则用于将植入物112、302与推进器分离的力的范围通常高达250克力。
输送推进器102、202或301可包括核心芯棒218和至少一根导电线108、110、208、210、308或309。核心芯棒218可用作导电体,或者可用一对导线,或者可用双极性线,如前述的那样。
尽管脱卸系统100、200和300被描绘为用于输送线圈,但在本发明中也可预期其它植入物装置。例如,图8示出了如之前在图4描绘的那样的脱卸系统300,其具有为支架390的植入物。支架390可通过与前面关于脱卸系统100、200和300描述的方法类似的方法被类似地脱卸。在进一步的示例中,脱卸系统100、200或300可用于将过滤器、网格、台架或其它适于输送的医疗植入物输送到病人体内。
图7呈现了输送推进器350的一个实施例,其可在任意一个实施例中用作输送推进器102、202或301,其包括射线不透材料,以便将输送推进器350的位置通知给使用者。具体地,射线不透标识器材料被集成到输送推进器350中,并且在期望的位置处改变厚度,从而便于更容易和更精确地制造最终的输送推进器350。
诸如通过引用合并于此的授予Guglielmi的美国专利5,895,385中公开的现有技术的输送推进器设计依赖于高密度材料,例如以环形带或线圈形式的金、钽、钨或铂。射线不透标识器随后被结合到其它密度较小的材料,例如不锈钢,以区分出射线不透的部分。因为射线不透标识器是放置在与输送推进器的末端相距规定距离(通常约3cm)的分开的元件,所以该放置必须准确,否则输送推进器350的末端能够导致对动脉瘤的损伤或导致其它并发症。例如,输送推进器350可从微导管中过度延伸从而刺穿动脉瘤。另外,实现现有技术的输送推进器的制造过程可能是困难和昂贵的,特别是在结合不类似的材料的时候。
通过将第一射线不透材料集成到输送推进器350的大部分中,同时改变第二射线不透材料的厚度,本发明的射线不透系统克服了这些缺点,因此不需要将多个部分结合到一起。如图7可见,输送推进器350包括优选由诸如钨、钽、铂或金(与大部分的现有技术设计的射线可透材料(例如,钢、镍钛诺和埃尔吉洛伊合金)相反)的射线不透材料制成的核心芯棒354(即第一射线不透材料)。
输送推进器350还包括具有不同的射线不透水平的第二外层352。优选地,外层352由射线不透值比核心芯棒354小的材料构成,例如埃尔吉洛伊合金、镍钛诺或不锈钢(可从Fort Wayne Metals买到,商标名为DFT)。在这点上,核心芯棒354和外层352都可见,并且两者在荧光下可彼此区分开。外层352的厚度沿输送推进器350的长度变化,以提供增加的柔性和射线密度上的区分。因此,对于使用者来说,外层352的较厚区域在荧光下比较薄区域更明显。
外层352的厚度转变通过诸如研磨、拉拔或锻造这样的自动化过程能够在期望的位置上精确地产生。这些自动化过程消除了手动测量和放置标识器的需要,并且进一步消除了将分离的标识器元件结合到其它射线透过部分的需要,因此降低了制造成本和系统的复杂性。
在本实施例中,输送推进器350包括外层352的三个主要指示区域。近端区域356是这三个中最长的,为137cm,而中间区域358为10cm,远端区域360为3cm。每个区域的长度能够基于输送推进器350的用途被确定。例如,3cm的远端区域360可在线圈植入过程中被使用,如本领域已知的那样,从而允许使用者将远端区域360的近端边缘与微导管上的射线不透标识器对准,其中输送推进器350被定位于微导管中。每个区域的直径取决于应用和植入物的尺寸。例如,对于典型的脑动脉瘤应用,近端区域356可典型地度量为0.005-0.015英寸,中间区域358可典型地度量为0.001-0.008英寸,而远端区域360可典型地度量为0.0005-0.010英寸。核心芯棒354在任何点处通常包括位于输送推进器350的总直径的约10%-80%之间的尺寸。
可替代地,输送推进器350可包括比图7中所示的三个区域多或少的任何数量的不同区域。另外,核心芯棒354的射线不透材料可仅部分地延伸通过输送推进器350。例如,射线不透材料可从核心芯棒354的近端延伸到距离输送推进器350的远端3厘米的位置,从而提供在荧光下可见的另一预定位置标识器。
在这一点上,所述输送推进器350的区域356、358和360提供了易于制造且在荧光下相当明显的更精确的射线不透标识系统。进一步地,增加的标识器的精确性可减少与在过程中输送推进器的不适当的定位相关的并发症。
在操作中,微导管被定位在病人体内,使得微导管的远端靠近目标区域或管腔。输送推进器350被插入微导管的近端中,核心芯棒354和外层352在荧光下可见到。使用者将微导管上的射线不透标识器与远端区域360的起点对准,这传达了植入物112、302相对于微导管的末端的位置。
在一些情况下,例如,在由于输送推进器350的刚性使得血管损伤风险升高的小动脉瘤的情况下,使用者在脱卸期间可将植入物的近端定位为稍微在微导管的远端内。使用者随后可采用下一个线圈、诸如引导线这样的附属装置或输送推进器102、202、301或350来将植入物112、302的近端推出微导管。在另一实施例中,使用者可使用射线不透标识系统将输送推进器的远端放置在微导管的远端外部。
一旦脱卸系统100、200或300的植入物装置112、302被放置在目标部位中或目标部位周围,则当需要或期望时,操作者可重复地重新定位植入物装置112、302。
当期望脱卸位于目标部位处的植入物装置112、302时,操作者通过电线108、110、208、210、308或309向加热器106、206或306施加能量。该能量的电源可以是任何适当的电源。例如壁式插口、电容、电池等。关于该方法的一个方面,根据脱卸系统100、200或300的阻抗,电势为约1伏至100伏的电力被用于产生1毫安至5000毫安的电流。
图6示出了可被用于将脱卸系统100、200或300电联接到电源的连接器系统400的一个实施例。连接器系统400包括导电的核心芯棒412,导电的核心芯棒412的近端被绝缘层404包围。优选地,绝缘层404为绝缘套管,例如聚烯烃、PET、尼龙、PEEK、特氟纶或聚酰亚胺的塑料收缩管。绝缘层404还可以是诸如聚亚安酯、硅树脂、特氟纶或派瑞林(paralyene)的涂层。导电带406布置在绝缘层404的顶部,并且通过模制的带414、粘接剂或环氧树脂被固定就位。因此,核心芯棒412和导电带406彼此电绝缘。导电带406优选由例如银、金、铂、钢、铜、导电聚合物、导电粘接剂或类似材料的任何导电材料构成,并且可以是带、线圈或薄片。因为金能够被拉成薄壁并且可以容易买到,因此金特别优选作为导电带406的导电材料。核心芯棒412之前已经进行了描述,并且可被电镀有例如金、银、铜或铝,以增强其导电性。
连接器系统400还包括两根电线408和410,其分别连接到导电带406和核心芯棒412,并且连接到诸如图1、图2和图4(图6未示出)中所描述那样的位于输送系统远端处的加热元件。这些线408和410优选通过钎焊、铜焊、焊接、激光焊接或导电粘接等类似技术被连接起来。
一旦使用者准备好将植入物112、302释放在病人体内,则来自电源的第一电夹或连接器被连接到核心芯棒412的非绝缘部分402,来自电源的第二电夹或连接器被连接到导电带406。电功率被施加到第一和第二电夹,在脱卸系统100、200或300中形成电路,使得加热器106、206或306的温度增加,并且使栓系件104、310断开。
一旦脱卸系统100、200或300被连接到电源,则使用者可应用电压或电流,如之前所述的那样。这导致加热器106、206或306的温度增加。当被加热时,由于热感应的蠕变,所以预先被张紧的栓系件104、310将趋向于恢复到其无应力(较短)的长度。在这一点上,当栓系件104、310被加热器106、206或306加热时,其总的尺寸缩小。然而,因为栓系件104、310的每一端如前所述那样被固定就位,因此栓系件104、310的长度不能缩短,最终断裂而释放植入物装置112、302。
因为在系统中已经有以弹簧116或栓系件材料104、310的变形的形式的张紧,所以使栓系件104、310断裂所需的收缩的量小于不具有被预先张紧的栓系件的系统。因此,用于自由释放植入物装置112、302所需的温度和时间降低。
图5为示出了脱卸系统300的PET覆盖物304的表面处的温度与加热器线圈306被激活的时间段之间的关系的曲线。可见,脱卸系统300在脱卸期间的表面温度相对于时间不是线性变化。具体地,加热线圈306产生的热刺穿绝缘覆盖物304仅仅只用了1秒。在1秒之后,绝缘盖304的表面温度急剧增加。尽管不同的外部绝缘材料可稍微增加或减小这1秒的表面温度窗口,但脱卸系统100、200或300所必需的小直径阻止了提供厚的绝缘层,而厚的绝缘层可能更明显地延迟表面温度的增加。
应该理解的是,脱卸系统100、200或300的实施例包括多种可能的结构。例如,绝缘覆盖物304可由特氟纶、PET、聚酰胺、聚酰亚胺、硅树脂、聚亚安酯、PEEK或具有类似特性的材料构成。在实施例100、200或300中,绝缘覆盖物的典型厚度为0.0001-0.040英寸。该厚度在装置适于用在例如较近的畸形体中时将趋于增加,而在装置适于用在例如脑动脉瘤等更远且更曲折位置时则趋于减小。
为了使这种由表面温度的增加导致的损伤和可能的并发症最小,本发明在表面温度开始显著增加之前脱卸植入物装置112、302。优选地,植入物装置112、302在小于1秒内被脱卸,更优选地,小于0.75秒。这防止了表面温度超过50℃(122°F),更优选地,防止其超过42℃(107°F)。
一旦使用者尝试脱卸植入物装置112、302,通常必需确认脱卸已经成功。集成在电源中的电路可用于确定脱卸是否已经成功。在本发明一个实施例中,在施加脱卸电流(即用于激活加热器106、206或306以脱卸植入物112、302的电流)之前,提供初始信号电流。该信号电流被用于在使用者尝试脱卸植入物之前确定系统中的电感,并且因此具有比脱卸电流低的值,从而不导致过早的脱卸。在尝试脱卸之后,类似的信号电流被用于确定与初始电感值相比较的第二电感值。初始电感值与第二电感值之间的实质性差别则指示了植入物112、302已经被成功脱卸,而没有这种差别则指示了不成功的脱卸。在这一点上,使用者能够容易地确定植入物112、302是否已经被脱卸,甚至对于采用非导电温度敏感聚合物来附接植入物的输送系统也是如此,如图1、图2和图4中可见的那样。
在下面的说明和示例中,除非额外注明,术语“流”和“电流”用作最普通的概念,并且被理解为包括交流(AC)、直流(DC)和射频电流(RF),除非另有所指。术语“变化”被定义为电流中以零以上的频率进行的变化,包括高频和低频。当值被测量、计算和/或保存时,应该理解的是,这可以通过手动或者通过任何已知的电子方法进行,包括但不限于电子电路、半导体、EPROM、计算机芯片、诸如RAM、ROM或闪存等的计算机存储器,等等。最后,线绕组和环形线圈形状具有宽泛的含义,并且包括各种几何形状,例如圆形、椭圆形、球形、四边形、三角形、以及梯形形状。
当变化的电流通过诸如线绕组或环形线圈这样的物体时,其建立磁场。随着电流增加或减小,磁场强度以相同的方式增加或减小。这种磁场的波动导致已知为电感的效果,其倾向于和电流中的任何进一步的变化相反。根据下面的公式1,在核心周围的线圈中的电感(L)依赖于匝数(N)、核心的横截面积(A)、核心的磁导系数(μ)以及线圈的长度(l):
公式1:
加热器106或306由具有附接到电源的近端和远端导线108、110、308或309的卷绕线圈形成。栓系件104、310具有磁导系数μ1,并且被定位为通过阻抗加热器的中心,其具有长度为l、横截面积为A、N匝,形成了如前面公式中描述的核心。在脱卸之前,以频率f1的变化的信号电流i1,例如图3A和3B中所述的波,被发送通过线圈绕组。该信号电流通常不足以脱卸植入物。基于信号电流,感抗XL(即由于系统中的电感所导致的电阻)被诸如欧姆计的电路测量。系统的初始电感L1随后根据公式计算:
公式2:
根据公式1,这个初始电感值L1依赖于栓系件104、302的核心的磁导系数μ1,并且被保存用于参考。当期望脱卸时,较高的电流和/或与信号电流频率不同的电流通过阻抗加热器线圈被施加,导致栓系件104、310释放植入物112、302,如之前描述的那样。如果脱卸成功,则栓系件104、310将不再存在与加热器106、306中,加热器106、306的内部将被另一材料填充,例如病人的血、造影介质、盐溶液或空气。现在位于加热器核心内的这些材料将具有与栓系件核心的磁导系数μ1不同的磁导系数μ2。
第二信号电流和频率f2被发送通过加热器106、306,并且优选地与第一信号电流和频率相同,但其中的一个或者二者都不相同并不会影响系统的操作。基于第二信号电流,计算出第二电感L2。如果脱卸成功,则由于核心磁导系数μ1和μ2不同,所以第二电感L2将不同于(高于或低于)第一电感L1。如果脱卸不成功,则电感值将保持相对相似(具有因为测量误差导致的一些容差)。一旦通过比较两个电感之间的差从而确任已经脱卸,则可激活警报或信号,以向使用者传达成功脱卸。例如,警报可包括蜂鸣器或指示灯。
优选地,根据本发明使用的输送系统100、300连接到在期望的时间自动测量电感、执行要求的计算、并在植入物装置已经从输送导管脱卸时向使用者发送信号的装置。然而,应该理解的是,这些步骤中的部分或全部都可手动执行,以达到相同的结果。
在被附接和脱卸之间的电感还可优选地不通过直接计算电感而被确定。例如,在脱卸之前或之后,感抗XL可被测量和比较。在另一示例中,脱卸可通过测量和比较系统的时间常数而被确定,系统的时间常数为电流到达其额定值的预定百分比所需要的时间。因为时间常数依赖于电感,因此时间常数的变化可类似地指示电感的变化。
本发明还包括与上述脱卸检测结合使用的反馈算法。例如,在前一次尝试脱卸植入物装置失败时自动增加脱卸电压或电流的算法。该循环包括:测量、尝试脱卸、测量和增加脱卸电压/电流,该循环持续进行,直到脱卸被检测到或者达到预定电流或电压极限为止。在这一点上,低功率脱卸可以是第一次尝试,随后自动增加功率或时间,直到脱卸发生为止。因此,用于提供脱卸功率的机构的电池寿命增加,而平均的线圈脱卸时间则极大减少。
现在参见图9和图10,其示出了本发明的植入物输送系统500的一个实施例。该植入物输送系统500和连接器系统501基本上分别与本申请之前所述以及在图4和6中示出的输送推进器301和连接器系统400类似。然而,植入物输送系统500优选包括传感器502,该传感器502用于检测植入物装置302何时已经从微导管506出来到达期望的脱卸位置。
通常,植入物装置302的脱卸优选在植入物装置302一旦已经完全退出微导管506时进行。在这一点上,传感器502被定位为在推进器301上靠近植入物装置302。传感器502检测其环境(即从位于微导管506中的位置到位于微导管506外但位于病人的脉管系统中的位置)的变化,该变化沿线504被传输到连接器系统501,最后传输到使用者附近的人机接口或显示装置(未示出)。优选地,人机接口可包括仪表、电子显示器、可听音等。
在又一个未示出在图中的优选实施例中,植入物装置302被用作检测机构,代替或者附加到传感器502。在将推进器500引导到脉管系统中的目标部署部位期间,推进器500保持在微导管506中,植入物装置302的线圈保持成相对直,因为其被限定了微导管506内管腔的壁所约束。当植入组件被部署时,植入物装置302的线圈回复到弯曲配置。植入物装置302的线圈从其远端到其近端的相对阻抗随着线圈从直的配置变为盘卷的配置而发生变化。这样,阻抗中的变化可以用作位置检测的机制。
在一个优选实施例中,传感器502可为温度传感器,检测微导管506的内部和外部的温度差(例如,离开正常状态或无偏状态的变化)。由于微导管506被布置在脉管系统的时间相对较短,所以微导管506的内部温度通常比脉管系统的温度冷。因此,当传感器502到达紧接在微导管506外部的脱卸区域(即优选的脱卸位置)时,温度明显增加。这种温度的跃变因此被用作在植入物装置302的推动期间指示已经到达脱卸区域。
在另一优选实施例中,传感器502为压力传感器,用于检测微导管506内部和外部的压力差(例如,离开正常状态或无偏状态的变化)。微导管506内的压力相对恒定,而微导管506外部的压力随着血流的收缩和舒张而改变。因此,从相对静态的读数到动态读数的突然的压力变化可用作指示植入物装置302已经被推到脱卸区域。
在另一优选实施例中,传感器502包括超声收发器和传感器,用于检测检测微导管506内部和外部之间的超声差(例如,离开正常状态或无偏状态的变化)。超声收发器发送超声波,并且接收波的回声,以确定到围绕该收发器的物体的距离。与脉管系统的壁相比,微导管的壁更靠近收发器。因此,由收发器测量到的距离的突然增加可作为指示植入物装置302已经被推到期望的脱卸区域。
能够检测微导管506的内部和外部的特性差别的其它传感器也可使用。
在另一优选实施例中,加热器线圈306可作为传感器,代替或附加到传感器502。随着热器线圈306被推动通过微导管506,其阻抗差(例如,离开正常状态或无偏状态的变化)可被测量。随着加热器线圈502退出微导管506,加热器线圈周围的环境从干燥和相对冷变化为脉管系统的充满温暖血液的环境。这种环境上的变化影响加热器线圈306的阻抗使之达到可测量的程度。下面的示例被提供以示出使用加热器线圈306作为传感器而获得的数据:
示例
已经进行了一系列实验,以确定当加热器线圈被推动通过微导管时加热器线圈的阻抗变化。为了得到数据的过程如下:
1、获取线圈推进器。
2、准备流模型。
3、测量和记录金连接器上的线圈阻抗。
4、将线圈推进器推入微导管中,稍微超过位于近端处的毂(hub)。
5、测量和记录线圈阻抗。标记该数据为推进器长度的0%时的数据。
6、将线圈推进器推动整个长度的大约50%。测量和记录线圈阻抗。标记该数据为推进器长度的50%时的数据。
7、重复步骤6到推进器长度的75%和100%,100%被定义为退出微导管远端的脱卸区域。
8、缩回推进器,在上述步骤(75%,50%和0%)处停下,测量和记录数据。
9、循环重复3次。
10、测量和记录最后一次位于微导管外部且在空气中的线圈推进器阻抗。
11、脱卸植入物和记录结果。
通过使用不同的导管类型和加热器线圈材料收集下列数据。表1-3中所示的所有阻抗值的单位都是欧姆。空值表示没有获得数据。百分比推进器长度被定义为推进器插入到微导管中的百分比,例如百分之一百等于脱卸线圈从微导管的远端退出。从位于推进器近端的金连接器开始测量阻抗。
该数据的结果是,通过测量两种加热器线圈材料(即Stablohm和铂)得到结论,Stablohm的热阻率系数比铂的热阻率系数高很多。具有较高热阻率系数的其它材料可被用于提供仪表读数的更高灵敏度。并且,数据显示,对铂线圈而言,推动线圈阻抗差为约0.5欧姆,而对于Stablohm而言则为0.4欧姆(从标记75%至100%)。
示例1
用于示例1的微导管为Rapid Transit微导管。使用的加热器线圈材料是Stablohm 710。流的温度为99华氏度。在测试之前,加热器线圈的阻抗为42.1欧姆。加热器线圈阻抗在测试之后没有记录。表1示出了示例1的结果。
表1
百分比推进器长度 | 推动阻抗1 | 推动阻抗2 | 缩回阻抗3 |
0 | 42.1 | 42.1 | 42.1 |
50 | 42.2 | - | 42.2 |
75 | 42.5 | 42.5 | - |
100 | 42.6 | 42.6 | 42.6 |
示例2
用于示例2的微导管为Excelsior 1018微导管。使用的加热器线圈材料为铂。流温度为98.7华氏度。在测试之前,加热器线圈的阻抗为40.9欧姆。加热器线圈阻抗在测试之后为40.9欧姆。表2示出了示例2的结果。
表2
示例3
用于示例3的微导管为Excelsior SL10微导管。使用的加热器线圈材料为铂。流的温度为98.6华氏度。在测试之前,加热器线圈的阻抗为40.8欧姆。加热器线圈阻抗在测试之后为40.7欧姆。表3示出了示例3的结果。
表3
尽管已经针对具体实施例和应用描述了本发明,但本领域技术人员根据本教导能够实现其它的实施例和修改,而不脱离要求保护的发明的精神或超出要求保护的发明的范围。因此,应该理解的是,这里的附图和说明书以示例的方式提出,以利于理解本发明,而不应该被解释为限制本发明的范围。
Claims (9)
1.一种用于确定植入物装置何时从微导管出来的系统,包括:
具有管腔和远端的微导管;
布置在所述微导管的所述管腔内的推进器;
能够被所述推进器推动通过所述管腔的植入物装置;和
布置为定位于所述推进器上且接近所述植入物装置的传感器,用于检测所述植入物装置何时已经从所述微导管出来到达期望的脱卸位置。
2.如权利要求1所述的系统,其中,所述传感器被配置为当所述传感器被推动通过所述微导管的所述管腔并且从所述微导管的所述远端出来时检测所述传感器周围环境的变化。
3.如权利要求1所述的系统,其中,所述传感器选自由温度传感器、压力传感器和接近传感器所构成的组。
4.如权利要求3所述的系统,其中,所述接近传感器采用超声波。
5.如权利要求1所述的系统,其中,所述传感器包括阻抗型加热器。
6.如权利要求5所述的系统,其中,所述阻抗型加热器包括线圈。
7.如权利要求1所述的系统,其中,所述传感器将所述植入物装置用作检测机构。
8.如权利要求1所述的系统,其中,所述植入物装置为线圈。
9.如权利要求1所述的系统,进一步包括与所述传感器进行数据流通信的人机接口装置。
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2008
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US10299755B2 (en) | 2019-05-28 |
AU2008340276B2 (en) | 2014-08-07 |
CA2710146A1 (en) | 2009-07-02 |
WO2009082716A1 (en) | 2009-07-02 |
JP2011507636A (ja) | 2011-03-10 |
AU2008340276A1 (en) | 2009-07-02 |
EP2231030B1 (en) | 2019-02-27 |
EP2231030A4 (en) | 2016-12-21 |
US20090163780A1 (en) | 2009-06-25 |
CN102065779A (zh) | 2011-05-18 |
JP5366974B2 (ja) | 2013-12-11 |
US20190231302A1 (en) | 2019-08-01 |
CA2710146C (en) | 2017-03-28 |
US9242070B2 (en) | 2016-01-26 |
US20160100819A1 (en) | 2016-04-14 |
EP2231030A1 (en) | 2010-09-29 |
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