CN101394779B - 防外渗护套 - Google Patents
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Abstract
图示的器材和方法提供了在关节镜检查手术中外渗物的最小化。防外渗护套允许外科医生在关节镜检查手术过程中将多余流体从手术区周围的软组织排出。
Description
技术领域
本发明涉及一种关节(内窥)镜检查手术领域,更具体地,涉及在肩关节镜检查手术过程中的流体处理。
背景技术
在最小程度地侵入性手术中,手术器具,比如套管针、套管和包括内诊镜、膀胱镜、关节镜、腹腔镜等的光学医疗器材,通过小的切口或入口被插进患者的身体或体腔内并被操纵以在患者体内进行手术。最小程度地侵入手术过程比开口手术更安全,而且患者恢复得更快,住院时间更短,健康护理成本更低。因此,最小程度地侵入变得重要起来,而且对于要实现这个目标的器材和方法也有持续的需求。已经受益于最小程度地侵入手术的一个领域是肩关节手术。在刚刚过去的几十年的时间内,肩关节手术经历了从开口性手术到关节镜手术的过程。这种发展是设备、器具和植入物方面技术进步的结果。
在手术过程中,流体被引入到手术域点,使关节扩张并控制流血。肩关节的关节镜检查手术的主要关注是外渗物。外渗物是组织间隙液的统称,比如血液、冲洗液或进入注射点周围的组织内的药物。溢入肩和旋肩胛区域的软组织内的流体对患者有负作用。这些作用中的一些作用包括气管压缩、关节内的血液聚集或凝块(关节血肿)、血管内血块的形成(血栓性静脉炎)、动脉损伤、神经损伤、关节周围的血管和神经的压缩(隔室综合症)、和感染。这些作用引起患者的疼痛和不适,并导致恢复时间变长。在手术过程中发生的外渗也会引起手术区域的不成熟的失败,促使外科医生急匆匆地处理。由于外渗物引起的上述作用,需要一些器材和方法来减少肩关节镜手术过程中的外渗。
发明内容
下面所示的各个器材和方法提供了在关节镜检查手术中流体外渗物的最小化。防外渗流入/流出护套允许外科医生将流体从手术区周围的软组织排出,而同时还提供流入和流出手术点的流体。防外渗流入/流出护套是多腔管,关节检查器件比如关节镜被插进所述多腔管。护套的近端部分设有流体端口、支管和其它的控制流体在护套内流动的装置。流入/流出护套的远端部分设有多个流入/流出孔。护套的本体或中央部分设有多个排流孔。每个流入/流出孔连通管内的一个或多个腔,于是允许流体在手术点和患者体外的源或槽之间进行流动。每个排流孔连通管内的一个或多个排流腔,于是允许流体从手术点周围的组织流出到患者体外的槽。防外渗流入/流出护套允许外科医生维持一个清楚的手术点并消除了第三冲洗器件的需要,同时减少了周围组织发生的流体外渗物的量。
附图说明
图1表示使用防外渗流入/流出护套在患者身上执行关节镜手术的方法。
图2表示在护套的远端部分上布置有流入/流出孔的防外渗护套。
图3是防外渗护套的径向截面视图。
图4是在其内部布置有关节镜的防外渗护套的径向截面视图。
图5是与人机工程手柄和关节内窥镜一起使用的防外渗护套。
图6是防外渗护套、关节内窥镜和人机工程手柄的分解视图。
图7是与人机工程手柄和关节内窥镜一起使用的防外渗护套的底视图。
图8是在密闭体上套有的防外渗护套。
图9是和防外渗护套结合使用的密闭体。
图10表示使用管壁内表面与密闭体的外表面来构成外排流腔的防外渗护套的径向截面视图。
图11是在密闭体被转动时布置在密闭体上的防外渗护套。
图12是防外渗最小化护套的视图,该护套具有内管、外管和布置在内外管之间的一个或多个排流腔。
图13是防外渗最小化护套的径向截面视图,该护套具有内管、外管和布置在内外管之间的一个或多个排流腔。
具体实施方式
图1表示使用防外渗护套2在患者的肩1上执行关节内窥镜手术的方法。所述防外渗护套在图中被插进患者肩部的关节囊3。画出了各种解剖界标,包括患者的锁骨4、肩胛骨5和肱骨6。比如关节内窥镜的关节镜器具7布置在防外渗护套内。
在肩关节镜手术中,外科医生通过第一入口将关节镜引入肩内,目的是看到手术区域。通过第二入口引入修整器件,以去除或修整外科医生确定要去除或修整的组织。可选择地,可以通过第三入口引入冲洗器件,目的是扩张关节和/或冲洗手术区域来维持清楚的视野。在关节内窥镜手术中使用的其它关节镜器件包括内诊镜、锥子、尖镐或刮刀。
图2表示在护套的远端部分上布置有流入/流出孔的防外渗护套。所述防外渗护套是以中央腔为特征的由弹性材料制成的管8,这些弹性材料比如尼龙、聚碳酸酯尿烷、聚亚铵酯、聚二甲基硅氧烷和聚乙二醇或橡胶。所述无创伤护套的内径其大小和尺寸被设计为能够紧紧地套在关节镜器件的外径上。管8的特征是具有带末端10的远端部分9和近端部分11。管的末端10为截头圆锥体形状并具有开口12,所述开口的直径稍微小于关节镜和/或硬质套管或者其它外科器件的末端的外径。可选择地,末端10可以具有弓形截面。所述开口被设置在所述护套内,于是外科医生可通过该开口将内诊镜或其它外科器件插进手术空间。护套的远端部分9还包括流入/流出孔13、洞或开口,所述孔与患者体外的流体源或真空源流体连通。所述流入/流出孔13用于使流体流到关节囊或手术区域并从其流出。管的本体或中央部分14设有多个排流孔15。所述排流孔15以这样的方式进行设置,即当所述护套在使用时,它们与围绕关节囊3或手术区域的组织流体连通。所述排流孔位于最靠近流入/流出孔的位置,相隔的距离选择成,在预期的手术中,所述流入/流出孔会布置在关节囊的内部并且排流孔会布置在覆盖并围绕着关节囊的身体组织内。每一个排流孔15连通一个或多个布置在所述管内的排流腔,于是使得流体从围绕囊3的组织排出,到达患者体外的槽。护套的近端部分设有由弹性体制成的彀16,以允许医疗人员能够容易地将防外渗(无创伤)护套拉动并将护套固定到硬质套管、关节内窥镜和/或关节镜器件。所述彀能够用于连接到流体源17、真空源18或人机工程学手柄。防外渗护套的近端部分还设有一些配件,比如锁套或卡式插锁,其附连到布置在关节内窥镜或其它器件上的配件或开口,于是固定所述护套2。
防外渗护套2的外表面可设有光滑的涂层,允许关节镜和硬质套管更容易地在操作点进行移动。例如,护套2可设有(PTFE或泡沫聚四氟乙烯)涂层或覆盖有活性水润滑剂。相反,护套2的内表面(即限定管腔的壁)可设有非滑涂层或者其它高摩擦系数涂层。例如,护套2的内表面可涂有联合挤压黏性热塑弹性体(TPE)。非滑涂层防止护套从硬质套管或关节镜的外表面轻易地滑脱,于是有助于防止防外渗(无创伤)护套绕关节镜扭曲或滑脱。
关节镜7在末端伸过开口12和可看见的手术空间。流入/流出孔13设在护套的远端部分。流入/流出孔13连通护套内的一个或多个流入/流出外腔。所述一个或多个外腔连通真空源、流体源、药物源或这些源的组合。因此,流入/流出孔用于手术过程中的流体与手术区的流入和流出。
护套的管和所述末端由同样的可消毒软聚合体制成。可选择地,流入/流出防外渗(无创伤)护套的末端能够由其弹性系数比护套近端的材料的弹性系数更高的弹性材料制成。护套的末端的内径比大多数关节镜的外径稍微小一些。
当护套2在使用时,使用者将关节镜7插进护套2。随着关节镜的末端滑过护套的末端,护套末端扩张。因为末端的内径小于关节镜的外径,末端将与关节镜的外表面构成密封。
图3是防外渗护套2的径向截面视图,而图4是在其内部布置有关节镜的防外渗护套的径向截面视图。护套2使用管壁的内表面19与关节镜的外表面20来形成流入和流出外腔。一个明显的上升管道,也称作平台,或相对陡峭的肋21从外壁的内表面径向伸出并沿着护套纵向延伸,从而与关节镜的外表面20构成密封,于是产生四个外腔22,23,24和25。一个或多个排流孔15布置在管体或管中央部分的外表面上。排流孔15与布置在肋21内的一个或多个排流腔26流通。排流腔26沿着护套纵向延伸,其尺寸大小能够容纳从关节囊或手术区周围的组织流出的流体。在护套的一个可选实施方案中,排流孔还可以与一个或多个外腔流体连通。排流孔的大小能够用于控制护套的渗透率。所述肋的端部可设有弹性凸缘或延长部分以提高在肋与关节镜之间构成的密封。
如图4所示,关节镜通过护套的中央腔27被插进护套内。在插入关节镜之前,关节镜可被套上或不套上第二保护护套。一旦被插入,关节镜的外表面就与肋21接触。则由肋、内诊镜的外表面和防外渗护套的外壁的内表面产生外腔22,23,24和25。各个肋用作纵向支柱,当它们支撑受压缩的护套时能够防止护套的毁坏。这些肋减少薄外壁在横轴方向未受支撑的跨度,进一步防止护套的毁坏。由肋与关节镜的外表面之间的接触形成的密封防止流体在外腔22,23,24和25之间流动。通过护套远端部分的流入/流出孔,外腔22,23,24和25促进流体基本连续地流到关节囊或手术区和/或从关节囊或手术区流出。止回阀或门还可被连接到流入/流出护套在外腔22,23,24和25内的内表面,以防止流出的流体返流向手术点并防止流入的流体从护套的近端流出。排流腔促进间质流体从关节囊周围的组织流出。
在关节内窥镜检查手术过程中,加压后的流体流过所述流入/流出孔,所述流体被用来扩张关节,冲洗关节囊、手术区或手术点并中断组织流血。加压后的流体、血液和碎片从围绕手术点的肩组织经过护套内的排流孔被排出。流体、血液和碎片的清除减少了肩关节镜手术过程中在肩组织内遗留的流体的数量,从而使外渗达到最小。为了使外渗最小,外渗最小器件的渗透率大于周围组织的渗透率。渗透率的差别优选地为约10%至约15%,以有助于维持手术过程中关节内的压力。
图2至4中描述的防外渗护套当被制造来用作较大关节的关节镜检查器件时,其通常具有的外径尺寸是大约5到8毫米,但是这个尺寸可以根据关节镜检查器件的直径发生变化。当流入/流出护套被制造来用作较小关节的关节镜检查器件时,护套的外径尺寸大约为2到5毫米。根据挤压和构成管的材料的不同,流入/流出护套的外壁厚度通常1毫米或更小。流入/流出套管能够安装以护套标称直径的+/-10%的一系列关节镜。所述肋从防外渗护套的内表面向内伸出,并在插入关节镜时构成紧密配合,从而在护套内同心地保持关节镜。
防外渗护套2和关节镜7可以连同人机工程手柄32一起使用,如图5,6,7所示。图5是与人机工程手柄和关节内窥镜一起使用的防外渗护套,而图6是防外渗护套、关节内窥镜和人机工程手柄的分解视图。手柄包括用来接收关节镜7的近端的接收器33,关节镜7带有硬质套管34,硬质套管34具有接头35。手柄和护套通过位于护套近端部分的彀16借助搭扣配合或摩擦配合实现可拆卸地连接。手柄设有可操作地连接到关节镜的用户界面和控制系统36和流体管理系统比如关节镜流体泵。当护套被连接到手柄时,所述控制系统可被用来调节流体流入和流出护套。当关节镜7可操作地连接手柄32时,所述控制系统36还被用来控制关节镜的聚焦。光缆37和电缆通过光电耦合器可操作地连接到手柄的近端部分。
图7是与人机工程手柄和关节内窥镜一起使用的防外渗护套的底视图。手柄32还包括布置在它的底部40的纵向通道39。所述纵向通道的尺寸和大小能够容纳可操作地连接到护套的流入/流出管41。管41摩擦安装到通道39。所述通道提供了基本在使用者手腕下面进行传送的管道,该管道不是象现有的护套和关节镜那样在使用者手腕的一侧进行传送。
图8是在密闭体42上套有的防外渗护套或套管。防外渗护套2是以中央腔为特征的由弹性材料聚合体制成的管8,这些弹性材料比如尼龙、聚碳酸酯尿烷、聚亚铵酯、聚二甲基硅氧烷和聚乙二醇或橡胶。防外渗(无创伤)护套的内径尺寸和大小能够紧紧安装在密闭体的外径上。该管的特征是带末端10的远端部分9和近端部分11。防外渗(无创伤)护套的末端具有截头圆锥体形状和开口12,开口12的直径稍微小于关节镜和/或硬质套管或其它手术器件末端的外径。可选择地,所述末端具有弓形截面。开口12设置在护套内,于是外科医生能够插入密闭体。管的本体或中央部分14设有成一系列直线排列的多个排流孔15。每个排流孔15连通一个或多个布置在管内的排流腔,于是允许流体从手术点周围的组织排出到患者体外的槽内。护套的近端部分11设有由弹性体制成的彀16,以允许医疗人员容易地拉动防外渗(无创伤)护套并将护套固定到密闭体、关节镜和/或关节镜检查器件。此外,彀用于连接到流体源、真空源或人机工程手柄。防外渗护套的近端部分还带有各种配件,比如锁套或卡式插锁,其附连到布置在关节内窥镜或其它器件上的配件或开口,于是固定所述护套2。
图9是和防外渗护套结合使用的密闭体42。所述密闭体包括圆柱轴43,该轴带一个或多个沿着密闭体外表面的纵向布置的槽、通道或凹槽44。密闭体带有布置在它的近端上的手柄45。当密闭体布置在护套内时,该手柄可用来转动密闭体。密闭体还可以带有中央腔,以允许密闭体滑过杆或导线。
图10表示使用管壁内表面与密闭体的外表面来构成外排流腔的防外渗护套的径向截面视图。管壁19的内表面和密闭体的外表面46构成密封,凹槽的侧壁47、48与底壁49和管壁产生纵向外排流腔50,51,52,53。一个或多个排流孔15布置在护套本体或中央部分的外表面上。排流孔15与一个或多个排流腔50,51,52,53流通。排流腔50,51,52,53沿着护套纵向延伸,并且其尺寸和大小能够容纳从手术点周围的组织流出的流体。排流孔15的尺寸能够用来控制护套的渗透率。
当护套在使用时,使用者将密闭体插进护套。当关节镜的末端滑过护套的末端时,护套末端扩张。因为护套末端的内径小于关节镜的外径,该末端将与关节镜的外表面构成密封。所述各个通道基本与各列流体孔对齐。当使用者想停止或减少流体通过护套从手术点周围的组织外流时,使用者转动密闭体42并使凹槽44与各列流体孔15不对齐,如图11所示。
密闭体42或其它具有纵向槽44的关节镜手术器件通过所述中央腔被插进护套。在插入之前,密闭体42被第二护套套住,或者不套。一旦插入后,密闭体的外表面46接触护套的内表面19。密闭体的外表面46的力施加在护套内表面19上。外排流腔50,51,52,53由凹槽44和防外渗护套2的外壁的内表面19产生。由护套和密闭体外表面之间的接触形成的密封防止流体在外排流腔50,51,52和53之间流动。外排流腔50,51,52和53促进流体从手术点周围的组织穿过护套中央的排流孔15后流出。
图12和13表示防外渗最小化护套2的视图,该护套具有内管58、外管59和布置在内外管之间的一个或多个排流腔60,61,62和63。多个排流孔15布置在外管的中央部分14或管本体内。排流孔以这样的方式进行布置,即当护套在使用时,设置排流孔与手术点周围的组织流通。每个排流孔连通一个或多个布置在护套内的排流腔,于是允许流体从手术点周围的组织排到患者体外的槽内。护套的近端部分11设有彀16或支管,允许医疗人员容易地拉动护套并将护套固定到硬质套管、关节镜和/或关节镜检查器件。彀16用于连到与真空源或槽流通的排放管。防外渗护套的近端部分11还可设有各种配件,比如锁套或卡式插锁,其附连到布置在关节内窥镜或其它器件上的配件或开口,于是固定所述护套。可滑动的套64套在护套2的外径上,以控制排流孔对手术点周围的组织的暴露数量并且容纳各种厚度的突出部。
图13表示防外渗最小化护套2的径向截面视图,该护套具有内管58、外管59和布置在内外管之间的一个或多个排流腔60,61,62和63。防外渗护套包括外管、内管,其特征是中央腔65和以护套内纵向延伸的排流腔60,61,62和63为特征的多个肋66。内管的内径的尺寸和大小能够紧紧安装在关节镜检查器件的外径上。护套具有由内管的壁限定的中央腔65,通过该腔插入关节镜或其它关节检查手术器件。护套具有由内管58的壁、外管59的壁和四个相对刚性的肋66限定的四个外腔60,61,62和63,所述肋在内管和外管之间延伸并沿着护套的长度方向延伸。护套的末端9在外腔60,61,62和63区域内被紧紧密封并成圆形以有助于防止对患者的伤害(中央腔保持敞开以容纳关节镜器件)。布置在护套外壁内的排流孔15允许间质液从关节镜检查手术点周围的组织或关节囊流出并流进外排流腔。
防外渗最小化护套2能够是完整的流体管理系统的一部分,该系统包括流体源、真空源、关节镜检查手术泵和控制系统。超压阀可操作地连接到防外渗护套以允许器件内的排流腔打开,并且如果关节被关节镜检查泵过度增压则排放所述关节。
尽管所述器件和方法的优选实施方案已经参照开发它们的环境进行了说明,但是这些实施方案只是本发明原理的示意性说明。在不脱离本发明的精神和权利要求的范围的情况下,可以设计出其它的实施方式和结构。
Claims (18)
1.防外渗护套,其与关节镜检查器件一起使用以在体内的手术点执行关节镜检查手术,其中所述手术点位于上覆形体组织的下面,所述护套包括:
管,其具有远端部分、近端部分、外表面、内表面、内径和外径;
多个肋,其从所述管的内表面向内延伸并沿着所述管纵向延伸,其中当关节镜检查器件被插进所述护套时,所述肋在关节镜检查器件与各个肋之间形成密封,于是在所述管内限定多个纵向延伸的流入/流出腔;
至少一个布置在所述管的远端部分的流入/流出开口,所述流入/流出开口连通流入/流出腔和所述管的外部;和
布置在至少一个肋内的排流腔,所述排流腔在所述至少一个肋内纵向延伸,并且在所述管内的排流孔连通所述排流腔到所述管的外部,所述排流孔布置在所述流入/流出开口最近的位置,于是,当在手术点处使用时,流入/流出开口布置在手术点内,而所述排流孔布置在覆盖手术点的形体组织内。
2.如权利要求1所述的防外渗护套,其中所述肋还包括凸缘,当关节镜检查器件布置在护套内时,所说凸缘在所述肋与关节镜检查器件的外表面之间形成密封。
3.如权利要求1所述的防外渗护套,其中所述肋还包括延长部分,当关节镜检查器件布置在护套内时,所述延长部分在所述肋与关节镜检查器件的外表面之间形成密封。
4.如权利要求1所述的防外渗护套,还包括至少一个布置在所述管的远端部分的流入/流出孔,当关节镜检查器件被布置在护套内时,所述孔与至少一个限定在关节镜检查器件的外表面与所述管的内表面之间的外腔流体相通。
5.如权利要求1所述的防外渗护套,还包括至少一个布置在所述管的中央部分并与至少一个排流腔流体相通的排流孔。
6.如权利要求1所述的防外渗护套,还包括布置在其近端部分上的毂。
7.用于在体内的手术点执行关节镜检查手术的系统,其中所述手术点位于上覆形体组织的下面,所述系统包括:
适用于执行关节镜检查手术的关节镜检查器件;
防外渗护套,其内径的尺寸大小允许流体在护套的内表面和布置在护套内的关节镜检查器件的外表面之间流动,所述护套具有至少一个肋,所述肋从所述护套的内表面向内延伸并沿着所述护套的纵向延伸,至少一个排流腔布置在所述肋内;
其中所述肋在关节镜检查器件的外表面与护套的内表面之间限定至少一个流入/流出腔;和
其中所述护套适用于可拆卸地布置在关节镜检查器件上。
8.如权利要求7所述的系统,还包括至少一个布置在所述护套的中央部分并与所述排流腔流体相通的排流孔,所述排流孔连通所述排流腔到护套的外部,所述孔布置在离所述护套末端最近的位置,当在手术点处使用时,所述护套的末端布置在手术点内,而所述排流孔布置在覆盖手术点的形体组织内。
9.如权利要求7所述的系统,还包括至少一个布置在所述护套的远端部分的流入/流出孔,当关节镜检查器件被布置在护套内时,该孔与至少一个限定在关节镜检查器件的外表面与所述护套的内表面之间的外腔流体相通。
10.如权利要求7所述的系统,还包括与所述排流腔流体相通的真空源。
11.用于执行关节镜检查手术的系统,所述系统包括:
适用于执行关节镜检查手术的关节镜检查手术器件,所述关节镜检查手术器件具有至少一个布置在其外表面上的纵向通道;
防外渗护套,其内径的尺寸大小允许流体在护套的内表面和布置在护套内的关节镜检查器件的所述通道之间流动,所述护套具有至少一个布置在护套中央部分内的排流孔;
其中所述护套在所述通道和护套的内表面之间限定排流腔;和
其中所述护套适用于可拆卸地布置在关节镜检查器件上。
12.如权利要求11所述的系统,其中当所述至少一个布置在护套中央部分的排流孔基本与排流腔对齐时,所述至少一个排流孔与所述排流腔流体相通。
13.防外渗护套,包括:
内管,其内径的大小和尺寸能够紧密安装在关节镜检查器件的外径上;
套在所述内管上的外管;
多个在所述内管和外管之间沿护套的长度方向延伸的肋;
其中所述内管、外管和多个肋界定多个外排流腔,所述外排流腔在所述内管和外管之间延伸并沿着护套的长度方向延伸;和
多个布置在所述外管的中央部分的排流孔,所述排流孔与所述排流腔流体相通并用于在关节镜检查手术过程中将流体从关节镜检查区周围的组织排出。
14.如权利要求13所述的护套,还包括套在所述外管上的可滑动套。
15.防外渗护套,其包括:
管,其具有远端部分、近端部分、内表面和内径;
其中,所述管的内径的尺寸大小允许在关节镜检查器件布置在管内时,流体在管的内表面和关节镜检查器件的外表面之间流动;
多个肋,其从所述管的内表面向内延伸并沿着所述管纵向延伸;
沿着管纵向延伸并布置在肋内的至少一个排流腔;
其中当关节镜检查器件被插进所述管时,所述肋在关节镜检查器件的外表面与肋之间形成密封;
其中所述肋进一步限定在关节镜检查器件的外表面与所述管的内表面之间的外腔;
布置在所述管的远端部分上的至少一个流入/流出孔,所述流入/流出孔流体连通至少一个外腔,在关节镜检查器件布置在管内时,所述至少一个外腔限定在关节镜检查器件的外表面与所述管的内表面之间;以及
布置在所述管的中央部分上与至少一个排流腔流体相通的至少一个排流孔。
16.如权利要求15所述的防外渗护套,还包括布置在其近端部分上的毂。
17.用于执行关节镜检查手术的系统,所述系统包括:
适用于执行关节镜检查手术的关节镜检查器件;
防外渗护套,其内径的尺寸大小允许流体在护套的内表面和布置在护套内的关节镜检查器件的外表面之间流动,所述护套具有至少一个肋,所述肋从所述护套的内表面向内延伸并沿着所述护套的纵向延伸,至少一个排流腔布置在所述肋内;
其中所述肋在关节镜检查器件的外表面与护套的内表面之间限定外腔;
其中所述护套适用于可拆卸地布置在关节镜检查器件上;
布置在所述护套的中央部分上与所述排流腔流体相通的至少一个排流孔;
布置在所述护套的远端部分上的至少一个流入/流出孔,所述流入/流出孔流体连通至少一个外腔,在关节镜检查器件布置在管内时,所述至少一个外腔限定在关节镜检查器件的外表面与所述管的内表面之间。
18.如权利要求17所述的系统,还包括与所述排流腔流体相通的真空源。
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EP1983881A2 (en) | 2008-10-29 |
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JP5065301B2 (ja) | 2012-10-31 |
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EP1983881B1 (en) | 2013-06-05 |
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WO2007092662A3 (en) | 2008-01-31 |
JP2009525149A (ja) | 2009-07-09 |
US9186055B2 (en) | 2015-11-17 |
CN101394779A (zh) | 2009-03-25 |
EP1983881A4 (en) | 2011-03-16 |
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