CN114727828A - 用于治疗体腔血栓的*** - Google Patents
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Abstract
本公开总体上涉及血栓切除装置。示例性导管包括:发射器组件,该发射器组件包括至少一个发射器;其中每个发射器都包括电极对,并且其中每个发射器都构造成在对该对电极施加电压时产生多个空化气泡;由导管外壁的至少一部分形成的输注管腔,该输注管腔构造成接收导电流体,其中该发射器组件被收纳在输注管腔内,其中输注管腔的远侧段包括在导管外壁的一部分上的多个孔,并且其中多个孔构造成将导电流体和多个空化气泡释放到导管外以在治疗部位处治疗血栓;抽吸管腔,该抽吸管腔在其远侧段处包括抽吸端口。
Description
相关申请的交叉引用
本申请要求于2019年9月24日提交的题为“SYSTEM FOR TREATING THROMBUS INBODY LUMENS(用于治疗体腔血栓的***)”的美国临时专利申请No.62/904,974的优先权,通过引用将该申请的内容整体并入本文。
技术领域
本公开总体上涉及血栓切除装置,更具体地涉及被设计为产生空化气泡以从患者的脉管***减少或去除血栓的血栓切除装置。
背景技术
血栓切除装置被设计成减少凝块负担并从患者的脉管***中部分或完全去除血凝块(即血栓)。目前,大多数血栓切除装置中去除血栓的机制是机械的或涉及纤溶酶原启动剂(“tPA”)治疗和机械过程的组合。这些装置中的一些装置使用超声波来扩散组织纤溶酶原启动剂(tPA)。它通过增加血栓结构中的渗透性来实现这一点,从而露出更多溶栓剂可以结合的部位。这些装置都有缺陷,因为它们提供了不合意的缓慢的凝块去除速率,这通常要求在医院过夜。此外,这些装置往往价格昂贵、体积庞大且难以操作。再者,这些装置可能会导致患者大量失血。
因此,需要一种在不使用药物(例如,tPA)的情况下治疗血凝块并提供成本划算且节省时间的用于治疗血栓的解决方案的装置。
发明内容
本发明涉及血栓切除装置,其被设计成产生空化气泡以从患者的脉管***中减少或去除血栓。由于本发明的实施例不需要使用药物(例如tPA)并且可以快速起效(例如,不到2小时),因此本发明提供了一种成本划算且高效的用于治疗血栓的解决方案。
在一个实施例中,本发明提供了一种用于产生空化气泡的装置。示例性导管包括:包括至少一个发射器的发射器组件;其中每个发射器都包括电极对,并且其中每个发射器都构造成当电压施加到该对电极时产生多个空化气泡;由导管外壁的至少一部分形成的输注管腔,该输注管腔构造成接收导电流体,其中发射器组件被收纳在该输注管腔内,其中该输注管腔的远侧段包括在导管外壁的一部分上的多个孔,并且其中多个孔构造成将导电流体和多个空化气泡释放到导管外以在治疗部位处治疗血栓;抽吸管腔,该抽吸管腔形成在导管中并且在其远侧段处包括多个抽吸端口。
在一些实施例中,发射器组件包括:长形的导电管;绝缘线,在该绝缘线的一端处有螺旋盘绕部分,其中该盘绕部分包括露出的末端,并且其中该盘绕部分定位在长形导电管内;并且其中,当跨绝缘线和长形导电管施加电压时,电流配置成从绝缘线的露出的末端流到长形导电管以产生多个空化气泡。
在一些实施例中,长形导电管包括槽,并且其中电流配置成从绝缘线的露出的远侧末端流到槽的边缘。
在一些实施例中,电流配置成从绝缘线的露出的远侧末端流到长形导电管的内壁。
在一些实施例中,发射器组件包括第一线和第二线,其中从第一线的一部分去除绝缘材料的至少一部分,其中从第二线的一部分去除绝缘材料的至少一部分,其中第一线的一部分与第二线的一部分交错,其中,当跨第一导线和第二导线施加电压时,电流配置成从第一线流到第二线以产生多个空化气泡。
在一些实施例中,发射器组件包括:导电护套和具有露出的末端的绝缘线,其中电流配置成从绝缘线的露出的远侧末端流到导电护套以产生多个空化气泡。
在一些实施例中,多个孔成间隔开120度的三排布置在导管的外壁上。
在一些实施例中,输注管腔呈Y形。
在一些实施例中,泵构造成经输注管腔将连续的导电流体流输送到发射器组件。
在一些实施例中,连续的导电流体流经由多个抽吸端口将碎屑冲入抽吸管腔中。
在一些实施例中,泵构造成在抽吸管腔的近端处施加抽吸以经由多个抽吸端口将碎屑吸入抽吸管腔中。
在一些实施例中,多个抽吸端口中的一个抽吸端口大于多个孔中的一个孔。
在一些实施例中,导管进一步包括用于容纳导向线的导向线管腔。
在一些实施例中,导管进一步包括构造成密封导管远端的远侧罩帽,其中远侧罩帽包括用于容纳导向线的孔。
在一些实施例中,导管进一步包括用于容纳发射器组件的一根或多根线的电线管腔。
在一些实施例中,电压介于500V与1200V之间
在一些实施例中,所施加电压的重复率可在25Hz与200Hz之间进行调节。
在一些实施例中,电极对包括该对的电极之间的火花隙,该火花隙小于0.005英寸。
附图说明
图1A描绘了根据一些实施例的示例性发射器组件。
图1B描绘了根据一些实施例的示例性发射器组件。
图2A描绘了根据一些实施例的收纳发射器组件的示例性导管的横截面图。
图2B描绘了根据一些实施例的收纳发射器组件的另一示例性导管。
图3描绘了根据一些实施例的另一示例性发射器组件。
图4描绘了根据一些实施例的另一示例性发射器组件。
具体实施方式
呈现以下描述以使本领域普通技术人员能够制造和使用各种实施例。对特定装置、技术和应用的描述仅作为示例提供。对本文描述的示例的各种修改对于本领域普通技术人员来说将是显而易见的,并且本文定义的一般原理可以应用于其它示例和应用而不脱离各种实施例的精神和范围。因此,各种实施例并非旨在局限于本文描述和示出的示例,而是要符合与权利要求一致的范围。
本文描述了用于通过经由电压源产生空化气泡来从患者脉管***中减少或去除血栓的示例性***和方法。根据一些实施例,该治疗***包括导管和收纳在导管内的一个或多个发射器。导管在体腔(例如,血管)内被推进到治疗部位(例如,经由导向线)。每个发射器都包括电极,当连接到相对低电压和高PRF(脉冲重复率)发生器时,该电极形成等离子弧,等离子弧进而导致大量空化气泡形成和破裂。在一些实施例中,导管包括一排或多排空化孔,用于以全向方式释放空化气泡。空化气泡产生机械振动、湍流、射流和/或强力塌陷以削弱和破坏纤维蛋白纤维网络,从而减少和去除血栓。
本发明不同于电动液压碎石术。每个发射器处的电压(即,火花隙两侧)低于脉管内碎石术(“IVL”)治疗。在一些实施例中,发生器的电压在500V至1200V之间调整,并且重复率在25Hz至200Hz之间调整。为了保持击穿电压,发射器处的火花隙(例如,在电极对的两个电极之间形成的火花隙)足够小以允许产生火花。在一些实施例中,间隙小于0.005英寸。此外,传递的能量低于IVL,因此声功率一般不足以从任何冲击波产生压力幅度。
图1A描绘了根据一些实施例的示例性发射器组件100。发射器组件100包括两个导电长形管110和112。每个长形管都具有多个纵向槽以促进空化气泡的产生,如下文所述。此外,发射器组件100包括三根线102、104和106。在一些示例中,长形管可以是不锈钢海波管,并且线可以是聚酰亚胺绝缘的铜线。
第一绝缘线102在其远端处包括螺旋盘绕部分,该螺旋盘绕部分被放置在第一长形管110内。在一些实施例中,用粘合剂(例如,环氧树脂或氰基丙烯酸酯粘合剂)将螺旋盘绕部分结合到长形管110的内壁。类似地,第二绝缘线104在其远端处包括螺旋盘绕部分,该螺旋盘绕部分被放置在第二长形管112内。第三绝缘线106具有连接(例如,焊接)到第二长形管112的远端。此外,第二绝缘线104的近端连接(例如,焊接)到第一长形管110。
当发射器组件100连接到电压源时,电流穿过两个长形管和三根线线以在两个位置产生空化气泡。参考图1A,第一线102的近端连接到电压发生器(未示出)的正极端口,而第三导向线106的近端连接到电压发生器的负极部分。发生器以连续脉冲模式或一系列短脉冲提供能量。因此,电流i如箭头所示穿过发射器组件。如图所示,电流i从第一绝缘线102的近端流向其远侧盘绕部分。在第一绝缘线102的远端处,线的导电芯被露出,从而允许电流从线102的远端流到第一长形管110。第一线102的露出的远端和第一长形管110形成用于产生空化气泡的第一电极对。
电流i进一步从第一长形管110流到第二绝缘线104的近端,然后流到第二绝缘线104的远侧盘绕部分。在第二绝缘线104的远端处,线的导电芯被露出,从而允许电流从导向线104的远端流到第二长形管112。第二线104的露出的远端和第二长形管112形成用于产生空化气泡的第二电极对。然后电流i经由第三绝缘线106返回电压发生器。
当电流i从线的远侧盘绕部分流到包住盘绕部分的长形管时,在线的露出的远端与长形管的内表面之间形成了多个等离子弧。等离子弧以受控方式(一次一个,以特定速率)产生空化气泡,进而引起机械振动和其它气泡动力学相关效应,例如导电流体中的塌陷、湍流、喷射等(例如,经由气泡的膨胀和破裂)。机械振动用于减少或去除血栓。已知空化会削弱作为血栓基础结构的纤维蛋白网络交联。机械振动和气泡空化的组合可有效用于血栓溶解。与上述现有技术冲击波产生***中使用的发生器相比,该***的发生器构造成以较高的脉冲重复率产生较低电压的脉冲,以使任何冲击波的强度最小化并使泡沫的增长和塌陷优化和最大化。例如,在现有技术***中,每个脉冲可能为约3000伏特,重复率为1Hz。在该***的实施例中,电压脉冲的电压在500V至1200V之间调整;电压脉冲的重复率在25Hz至200Hz之间调整;脉冲占空比在10–50%之间调整。这些参数可以根据血凝块状况而变化。
图1B描绘了根据一些实施例的从不同的角度看去的示例性发射器组件100,示出了两根线的远侧盘绕部分。由于等离子弧在运行中对电极造成腐蚀,所以线102和104的螺旋盘绕线部分会随着时间而腐蚀和缩短。取决于线远端所在的位置,火花隙(即,形成等离子弧之处)可以在线远端与长形管的内壁之间(如细节A视图所示),或在线的远端与长形管的槽边缘之间(如细节B视图所示)。注意,随着盘绕线部分腐蚀,空化气泡的产生位置会发生变化。在图示实施例中,空化气泡的产生位置将围绕导电管110和112的***周向地旋转。
受让人的题为“SYSTEM FOR TREATING OCCLUSIONS IN BODY LUMENS”的在先申请美国公开号2019/0388110中提供了关于由盘绕线和长形管形成的电极对的额外细节以及可能的变化,通过引用将该申请并入。应该了解的是,虽然图1A-B描绘了包括由一个电压源驱动的串联连接的两个发射器的发射器组件,但是发射器组件可以包括由一个或多个电压源驱动的以任何构型布置的任何数量的发射器。
图2A描绘了根据一些实施例的包括多个管腔的示例性导管200的横截面图。导管200包括一个Y形输注管腔210和三个椭圆形管腔:导向线管腔204、电线管腔206和抽吸管腔208。如图2A所示,椭圆形管腔204、206、208沿着导管的外壁间隔开大约120度并且至少部分地由导管的外壁形成。导向线管腔204、电线管腔206和抽吸管腔208的内边缘限定了中央Y形输注管腔206的外边缘。
Y形输注管腔210收纳发射器组件202,该发射器组件202可以是本文描述的任何发射器组件(例如,100、300、400)。如上所述,发射器组件202包括多个长形的导电管和导向线,其形成多个发射器(或电极对)。在一些实施例中,发射器组件202被放置在导管的远侧段中。
Y形输注管腔210可进一步用于将离子溶液(例如,诸如盐水或与造影剂混合的盐水的导电溶液)从泵输送到发射器组件202。当发射器组件202连接到电压源时,可以经由导电流体在沿着导管的多个位置处产生空化气泡。
Y形输注管腔进一步包括用于释放空化气泡的多排空化孔。在所描绘的示例中,三排空化孔212a、212b和212c以120度间隔开。如图2A所示,空化孔212a、212b、212c可以包括沿着导管远端的圆周的一部分延伸的多个横向槽。空化孔可以定位成使空化气泡的释放最大化,例如,直接定位在第一长形管、第二长形管或发射器组件的另一元件上方。照此,来自发射器组件的空化气泡通过离子溶液流经多排空化孔被泵送到血栓而放射状地进行。
抽吸管腔208可用于从治疗部位去除碎屑(例如,金属、气泡)和血栓碎片。如图所示,抽吸管腔208包括一系列抽吸端口214。抽吸端口214一般比空化孔212大。随着更多的导电流体被注入,碎屑和血栓碎片被冲向抽吸管腔并被带离治疗部位。附加地或替代地,可以在抽吸管腔208的近端处提供抽吸。碎屑和血栓碎片可以被抽吸到抽吸端口214中并经由导电流体流被带离治疗部位。快速去除碎屑有助于恢复空化。
电线管腔206可用于容纳发射器组件202的一根或多根线。例如,将发射器组件的远侧部分连接到电压发生器的负极端口的线(例如,线106)可以延伸穿过电线管腔206以获得更好的绝缘。线管腔206还可以承载一根或多根另外线,例如,将发射器组件的近侧部分连接到电压发生器的正极端口的线102。导向线管腔204可用于容纳导向线,并且可成形为承载直径在约0.014英寸与约0.035英寸之间的导向线。导向线用于将导管200推进到治疗部位。
图2B描绘了根据一些实施例的收纳发射器组件的另一示例性导管。如图所示,导管包括罩帽230,该罩帽230包括用于接收导向线(例如,在导管推进期间被携带在导管的导向线管腔中的导向线)的导向线端口。此外,在图2A所示的实施例中,抽吸端口和空化孔的形状和位置是不同的。例如,如图2B所示,抽吸端口可形成为纵向狭槽,其尺寸确定成允许来自空化的碎屑经抽吸端口逸出。空化端口可以包括导管壳体(即导管的外壁)中的多个近似圆形的孔,从而允许进入Y形输注管腔。
图2A-B中的导管可以与泵结合使用。在一些实施例中,泵将离子溶液(即,诸如盐水或与造影剂混合的盐水的导电溶液)经由输注管腔输送到发生空化的导管末端。泵或辅助泵还将碎屑吸离血栓区域。输注流可以与发射器的电力传输同步,以确保发射器周围有足够的离子溶液。抽吸流和输注流可以是同步的,以保持治疗部位处的压力平衡。在一些示例中,调节盐水或盐水/脉管造影剂的流量以避免过热问题并控制治疗效率和速率。
在一些实施例中,在治疗***中包括另外的部件,例如用于捕获由发射器产生的碎片的近侧球囊、可视化***和/或用于正确导航(例如,侧枝)和放置导管的操纵***等。上面引用并通过引用方式并入本文的美国公开号2019/0388110中提供了治疗***的其它细节。
在一些实施例中,该程序可能需要大约30分钟,在此期间发射器组件202连续产生空化气泡。这些操作参数(例如,电压脉冲的电压、重复率或脉冲占空比)可以基于血凝块的特点(例如,凝块的大小、凝块的年龄、凝块的成分、凝块的柔软度、凝块的动脉或静脉位置、凝块的血小板含量、凝块的纤维蛋白含量或凝块的一些其它属性)和/或患者的特点(例如,患者的年龄或先前存在的医疗状况)来设置。在一些实施例中,在手术之后,可以执行术后微创手术(例如,出血治疗、血栓重整)。
图3描绘了根据一些实施例的收纳在导管300中的另一个示例性发射器组件。发射器组件包括四根线302、304、306和308。四根线中的每根线都包括螺旋地缠绕在轴320(例如,具有用于承载导向线的管腔的导向线轴周围的部分)周围的部分,并且这四根线共同形成三个交错线部分。交错线部分可以包括线的以交错方式构成的多个(即,2个或更多个)部分。例如,交错线部分可包括与另一根线的一部分盘绕的线的一部分。在一些变型中,线和交错线部分串联配置。例如,第一线302可以电联接到电压源的正极端子。第一交错线部分可以包括第一线302的与第二线304的第一部分交错的部分。第一线302可以具有比第二线304更正向的电压或电势。类似地,第二交错线部分304可以包括第二线304的与第三线306的第一部分交错的第二部分。第二线304可以具有比第三线306更正向的电压或电势。第三交错线部分306可以包括第三线306的第二部分和第四线308的一部分。第三线306可以具有比第四线308更正向的电压或电势。第四线308可以电联接到电压源的负极端子。
在图3所示的实施例中,每个交错线部分都包括至少一对电极。通过从交错线的相邻部分去除小绝缘区域来限定每对的电极。当在导向线被导电流体包围时(即,在导电流体流过线管腔时)向线输送高电压时,电液放电会产生等离子体,该等离子体会在电极上的电弧产生区域产生空化气泡。发射器组件的操作的其它细节和可能的变型可以在受让人的题为“Aortic leaflet repair using shock wave applicators(使用冲击波施加器修复主动脉瓣)”的在先申请美国公开号2018/0098779中找到,通过引用将该申请并入。
在图3所示的实施例中,发射器组件被收纳在导管300(例如,关于图2A-B描述的任何导管)内。如图所示,导管包括定位在发射器上方的多排空化孔(例如,纵向或横向槽或圆形孔),用于以全向方式释放空化气泡。
图4描绘了根据一些实施例的收纳在导管400中的另一个示例性发射器组件。发射器组件包括四根线402、404、406和408以及三个导电护套410、412和414。导电护套周向地缠绕轴420(例如,具有用于承载导向线的管腔的导向线轴)的一部分周围。外部电极由导电护套形成,而内部电极是通过去除绝缘线的一部分(例如,在线端部附近的绝缘层中挖孔)以露出绝缘线的导电部分而形成的。内部电极被放置在与导电护套的侧边缘相距受控距离的位置,以允许在给定电流和电压下产生可再现的电弧。在运行中,等离子弧可以穿过内部电极和导电护套的侧边缘形成。
在图4所示的实施例中,发射器组件经由例如第一线402和第四线408连接到电压源,其中第一线连接到正极端口,而第四线连接到接地的负极端口。电流从第一线402流到第一导电护套410、流到第二线404、流到第二导电护套412、流到第三线406、流到第三导电护套414、流到第四线408并流到电压源的负端口。因此,发射器组件在六个位置(即,每个导电护套的两侧边缘,其中护套与线的绝缘材料去除部分形成电极对)产生空化气泡。发射器组件的操作和可能的变量的其它细节可以在受让人的题为“Low profile electrodes fora shock wave catheter(用于冲击波导管的小型电极)”的在先申请美国公开号2019/0150960中找到,通过引用将该申请并入。
在图4所示的实施例中,发射器组件被收纳在导管400内,例如,关于图2A-B描述的任何导管。如图所示,导管包括定位在发射器上方的多排空化孔(例如,纵向或横向槽或圆形孔),用于以全向方式释放空化气泡。
应当理解,上述内容只是对本发明原理的说明,并且本领域技术人员可以进行各种修改、变更和组合而不脱离本发明的范围和精神。本文公开的各种冲击波装置的任何变型可以包括通过本文中的任何其它空化装置或空化装置的组合描述的特征。此外,任何方法都可以与所公开的任何冲击波装置一起使用。因此,除了受所附权利要求书限制外,本发明并非意在受到限制。对于所有上述变型,方法的步骤不必按顺序执行。
Claims (19)
1.一种导管,包括:
发射器组件,所述发射器组件包括至少一个发射器;
其中,每个发射器包括电极对,并且
其中,每个发射器构造成在对所述电极对施加电压脉冲时产生多个空化气泡;
由所述导管的外壁的至少一部分形成的输注管腔,所述输注管腔构造成接收导电流体,
其中,所述发射器组件被收纳在所述输注管腔内,
其中,所述输注管腔的远侧段包括在所述导管的外壁的一部分上的多个孔,并且
其中,所述多个孔构造成将所述导电流体和所述多个空化气泡释放出所述导管以在治疗部位处治疗血栓;
抽吸管腔,所述抽吸管腔形成在所述导管中并且在其远侧段处包括多个抽吸端口。
2.根据权利要求1所述的导管,其中,所述发射器组件包括:
长形导电管;
绝缘线,在所述绝缘线的端部处具有螺旋形盘绕部分,
其中,所述盘绕部分包括露出的末端,并且
其中,所述盘绕部分定位在所述长形导电管内;并且
其中,当跨所述绝缘线和所述长形导电管施加脉冲电压时,电流配置成从所述绝缘线的露出的远侧末端流到所述长形导电管以产生多个空化气泡。
3.根据权利要求2所述的导管,其中,所述长形导电管包括槽,并且其中,电流配置成从所述绝缘线的露出的远侧末端流到所述槽的边缘。
4.根据权利要求2所述的导管,其中,电流配置成从所述绝缘线的露出的远侧末端流到所述长形导电管的内壁。
5.根据权利要求1所述的导管,其中,所述发射器组件包括第一线和第二线,
其中,绝缘材料的至少一部分从所述第一线的一部分被去除以限定所述电极对中的一个电极,
其中,绝缘材料的至少一部分从所述第二线的一部分被去除以限定所述电极对中的第二电极,
其中,所述第一线的所述部分与所述第二线的所述部分交错,
其中,当跨所述第一线和所述第二线施加脉冲电压时,电流配置成从所述第一线流到所述第二线以产生多个空化气泡。
6.根据权利要求1所述的导管,其中,所述发射器组件包括:
导电护套,和
具有露出的末端的绝缘线,
其中,电流配置成从所述绝缘线的露出的远侧末端流到所述导电护套以产生多个空化气泡。
7.根据权利要求1所述的导管,其中,所述多个孔在所述导管的外壁上间隔120度排列成三排。
8.根据权利要求1所述的导管,其中,所述输注管腔呈Y形。
9.根据权利要求1所述的导管,其中,泵构造成经所述输注管腔将连续的导电流体流输送到所述发射器组件。
10.根据权利要求9所述的导管,其中,所述导电流体包括盐水。
11.根据权利要求9所述的导管,其中,所述连续的导电流体流将碎屑经由所述多个抽吸端口冲入所述抽吸管腔中。
12.根据权利要求1所述的导管,其中,泵构造成在所述抽吸管腔的近端处施加吸力以经由所述多个抽吸端口将碎屑抽吸到所述抽吸管腔中。
13.根据权利要求1所述的导管,其中,所述多个抽吸端口中的一个抽吸端口大于所述多个孔中的一个孔。
14.根据权利要求1所述的导管,进一步包括用于容纳导向线的导向线管腔。
15.根据权利要求14所述的导管,进一步包括构造成密封所述导管的远端的远侧罩帽,其中所述远侧罩帽包括用于容纳所述导向线的孔。
16.根据权利要求1所述的导管,进一步包括用于容纳所述发射器组件的一根或多根线的电线管腔。
17.根据权利要求1所述的导管,其中,所施加的电压脉冲的电压在500V与1200V之间。
18.根据权利要求1所述的导管,其中,所施加的电压脉冲的重复率可以在25Hz与200Hz之间进行调节。
19.根据权利要求1所述的导管,其中,所述电极对包括在该对的电极之间的火花隙,所述火花隙小于0.005英寸。
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2020
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- 2020-09-18 US US17/025,866 patent/US11478261B2/en active Active
- 2020-09-18 EP EP20786150.1A patent/EP4034006A1/en active Pending
- 2020-09-18 WO PCT/US2020/051551 patent/WO2021061523A1/en unknown
- 2020-09-18 AU AU2020354380A patent/AU2020354380A1/en active Pending
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WO2021061523A1 (en) | 2021-04-01 |
AU2020354380A1 (en) | 2022-04-07 |
US20230011207A1 (en) | 2023-01-12 |
US20210085348A1 (en) | 2021-03-25 |
JP2022548781A (ja) | 2022-11-21 |
US11478261B2 (en) | 2022-10-25 |
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