CN112774023A - 用于密封到血管的通路的护套 - Google Patents
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Abstract
一种用于产生对动物或人体的血管内部的完全密封通路的护套(10)包括具有管状主体的基部护套(20),管状主体限定通过通道(22)。基部护套(20)适于通过血管孔眼插入到血管中。基部护套的管状主体的壁具有直通通道(27)。这一通道在壁中从远端(20a)朝向近端(20b)延伸。通道(27)能够设置为独立于基部护套的通过通道(22),或者能够形成通过通道(22)的侧向延伸部,至少是在远端处形成。这种直通通道(27)适于在已将护套插入血管中时,将来自血管的血液导向护套的近端。
Description
分案申请
本申请是申请号为201580036594.4,国际申请日为2015年07月06日,进入中国国家阶段日期为2017年01月04日,发明名称为“用于密封到血管的通路的护套”的专利申请的分案申请。
技术领域
本发明涉及用于生产对动物或人体的血管的、例如动脉的内部的完全密封通路的护套。
背景技术
在对人体的经皮介入期间,例如当通过动脉或静脉(例如股动脉)引入心导管时,护套以不同的形式使用。下面将以简要和简化的形式阐述这种介入的不同步骤,以达到本发明的目的。
在第一阶段中,为此目的用穿刺针刺破血管。然后,通过该针将第一导丝插入血管中。去除针,并且第一护套沿着导丝插入血管中。上述步骤根据熟知的“Seldinger技术”进行。该护套通常包括基部护套、可移除的扩张器和在护套近端上、即在面向医生身体的护套端部上的止血阀。关于本发明,解剖方向术语将参考从业者来选择。护套具有约2mm的外径。扩张器和导丝被相继移除,使得只有第一护套的基部护套部分地保留在血管中。
在第二阶段中,刚性导丝现在通过剩余的基部护套插入到血管中,例如直到40cm的深度。此后,移除基部护套。导丝部分地保持在血管中。
可选地,这之后可以进行进一步预扩张,这里不再描述。任选地或替代地,代替施加小的中间护套,可以通过在初始部署的导丝上施加各种尺寸的扩张器来向上扩张穿入血管的穿孔。
沿着保持在血管中的导丝,该护套现在被插入到要引入心脏泵的血管中。在本申请的上下文中,“引入器”或“引入护套”是具有止血阀的护套。该引入护套通常具有约4.5mm至5mm的内径和约5mm至6mm的外径。引入护套的基本结构与上述第一护套的结构相同,即其由外基部护套、扩张器和止血阀组成。再次移除扩张器和导丝,其中引入护套的基部护套保留在血管中。现在已经形成了用于心脏泵的通路。
通过基部护套,现在通常沿着动脉将引导导管放置到左心室中。为此目的,可以采用例如所谓的猪尾导管,其由细管和软的远侧预弯曲引导尖端组成。支撑导丝可以已经插入在其中延伸的引导导管中,这支撑该导管。然后去除所述软的支撑丝,并且将较硬的导丝通过导管插入心脏。沿着硬导丝,在去除猪尾导管之后,将心脏泵插入心脏中。由此,心脏泵的进口位于左心室中,主动脉中的出口,并且导丝被取出。泵连接到供应导管,供应导管沿用于放置泵的动脉延伸,并且在血管孔眼(穿刺侧)处离开。或者,泵能够直接插入到基部护套中,并且在泵已经设计有以无创伤方式逆行地通过主动脉瓣所必需的适当特征的情况下,能够在不需要额外的引导导管和导丝的情况下被传送到心脏中。
已经用于插入心脏泵的引入护套现在从血管移除并被完全拉出,然后例如通过沿着预定分离线分离(“剥离”技术)以执行最终移除。现在,为再次在血管孔眼处闭合血管,即,为了闭合血管中的孔的周缘与泵的供应导管的外径之间的间隙,另一护套被沿着心脏泵供应导管的位于体外的部分插入血管中。最后提到的护套是本发明的主题。因为还可以例如经由供应导管通过该护套移位或重定位心脏泵,该护套也称为重定位护套(或“回流护套”)。
为了避免动脉中的血流扰动和潜在的低流动性或外表面相关的血栓形成,护套应当仅如必要深地插入血管中,并且具有刚好足以以完全密封的方式闭合血管的外径,即阻止否则将发生的出血或渗出。
因此期望能够可靠地识别护套是否以及何时已经插入到血管中足够深。这可以根据待穿透的皮下脂肪组织的厚度和/或通路的角度而变化,因此难以确定。
发明内容
因此,本发明目的是提出一种能够识别足够穿刺深度的护套。
该目的通过具有独立权利要求的特征的护套和方法实现。有利的实施例和改进在从属权利要求中陈述。
为此,护套包括具有管状主体的基部护套,管状主体限定直通通道。通常,护套在近端包括常规止血阀。基部护套适于通过血管孔眼插入血管中,即通过血管孔眼安装在血管中。
为允许识别穿透深度,基部护套的管状主体的壁能够具有直通通道。该直通通道在壁中从远端朝向近端延伸。该直通通道可以在护套的近端处或更早地、即在护套的远端和近端之间离开管状主体的壁到达护套外部。直通通道能够与基部护套的通过通道分开地存在。根据替代实施例,直通通道能够形成为通过通道的至少在远端处的侧向延伸部,即,其不必在其整个长度上与通过通道分开。当护套已经插入血管中时,这种直通通道适于将血液从血管导向护套的近端。以这种方式,一旦护套已经穿过组织插入血管中足够的深度,就能够可靠地看到。换句话说,通道使得能够获得一种插入深度指示器,简单地通过以下事实获得:一旦来自血管的血液在通道的近端处能够识别到,则能够推断出护套足够深地插入血管中。特别地,没有护套被超过所需地进一步插入血管中的危险,而这否则会再次引起血流扰动。
有利地,也可以以合适的方式通过通道采集血液用于诊断目的。这里的重要诊断方法特别是测量患者的血压和确定心输出量。为了测量血压,护套还可以包括连接到通道的血压测量装置。心输出量可以例如通过热稀释法来确定。为此,护套能够包括插入通过通道的温度测量元件,例如热敏电阻。
护套还可以包括导丝,其优选地能够通过通道安装。换句话说,通道由此适于将导丝从护套的近端经由通道插入血管。经由这样的导丝,即使在抽出泵之后,仍保持血管通路。
根据优选实施例,护套包括膨胀装置。后者适于与基部护套配合,使得当护套在血管中的静止位置的情况下并且当致动膨胀装置时,护套外径在血管孔眼的区域中增大。
为通过本实施例的护套生产到血管的完全密封通路,护套因此通过血管孔眼插入到血管中。此后,根据需要通过致动护套的膨胀装置而使护套外径在血管孔眼的区域中增大。
为在需要时增大护套外径,不需要将护套更深地插入到血管中,因为在护套处于静止位置的情况下,在血管孔眼的区域中增大护套外径是可能的。由于护套在其初始状态下、即无膨胀装置致动的情况下具有相对小的外径,能够避免血管孔眼的不必要加宽以及由于大外径或者长穿刺深度引起血管中的血流扰动。
旨在设计重定位护套,使其初始尺寸过小,例如。与由用于泵的引入护套产生的初始穿孔直径相比,护套的初始外径能够达到4F(=T.33mm)更小直径。这种尺寸过小外径的原因是,如果初始较大护套仅放置一段短时间(<60min),则血管本身可具有弹性地回弹到较小的孔的能力。应当理解,实现止血的最小阻塞物是最优选实施例,其中血管中具有最少量的外来物质,并且完全血管阻塞和不连续远端灌注的可能性最小。仅在没有或有限的血管反冲的情况下,重定位护套的膨胀部分将逐渐膨胀以获得止血。在优选实施例中,膨胀装置构造为使得护套的膨胀部分被限制于血管穿孔围绕的目标区域,允许穿过皮肤延伸到体外的接近护套凹进。以这种方式,在皮肤水平处仍然可见出血,从而需要膨胀部分的进一步膨胀。此后,不太可能在皮肤水平处插塞穿孔,并且可能在血管穿孔处具有到相邻组织中时的连续出血,其随后显示为圆形血肿。
根据另外优选实施例,膨胀装置被构造为在护套上在血管孔眼的方向上可移位的膨胀护套。这种膨胀护套可以例如以管状方式包围基部护套。通过使膨胀护套在基部护套上沿血管孔眼的方向移位,可以在进入血管的位置的区域中增大护套外径,而不将整个套管更深地插入到血管中。
不同于以上所述的膨胀装置的多个实施例也是可能的。例如,膨胀装置能够设置为不在基部护套上沿着血管孔眼的方向移位,而是布置在基部护套的直通通道中或围绕基部护套布置。这样的膨胀装置基本上能够构造为类似于扩张器,并且例如像球囊扩张器那样从内侧加宽基部护套或者布置在基部护套上的套筒(下面将更详细地描述)。球囊扩张器也可以布置在护套的外侧。根据优选实施例,提供了螺旋充气管形式的膨胀装置,其优选地布置在基部护套和套筒之间。充气管螺旋地缠绕在基部护套周围。在管的充气期间,护套膨胀,同时仍然在膨胀区域中是柔性的,即可弯曲的。
代替球囊扩张器等,还可以提供机械扩张元件,例如丝网状支架。这种扩张元件能够从收缩位置被带到膨胀位置,例如通过布置在护套的近端处并与扩张元件联接的致动元件的旋转或移位实现,从而在扩张元件的区域中增大护套外径。根据优选实施例,护套在待扩张的区域中包括柔性部分。该柔性部分形成基部护套的一部分,并且布置在近端和远端之间。柔性部分能够通过操作在远端处连接到基部护套的拉动装置而膨胀。
根据另一优选实施例,护套包括在待膨胀的区域中的可拉伸部分以作为膨胀装置。该可拉伸部分形成基部护套的一部分,并且布置在近端和远端之间。所述可拉伸部分被构造成在拉伸状态达到第一厚度并且在未拉伸状态下达到大于第一厚度的第二厚度,以便当基部护套的近端部沿着血管孔眼的方向从拉伸状态向未拉伸状态释放时,增大护套外径。换句话说,具有可拉伸部分的护套在拉伸状态下提供最小的外径。通过从护套的近端沿血管孔眼的方向释放所述拉伸,所述可拉伸部分达到未拉伸状态,这导致护套在述血管孔眼的区域中具有更大外径。该实施例在护套具有最小壁厚的情况下是有利的,该最小壁厚度阻碍通过轴向位移的均匀压缩。
可以提供任意其它形式的类似的扩张机构、膨胀机构或加宽机构作为膨胀装置。在另一个实施例中,可以通过用周围血液使材料(例如亲水胶)溶胀来使膨胀自动化,通过适当选择溶胀模量,该材料仅轻微地膨胀至“正确尺寸”,同时对血管的应力最小。
根据另一优选实施例,护套包括如已经指出的套筒。套筒包住基部护套和膨胀装置,使得当护套已经插入血管中时,即当护套在血管中处于静止位置时,套筒与血管孔眼接触。这能够防止当膨胀装置被致动、特别是推进以增大护套外径时,膨胀装置对血管的创伤性影响。这个套筒也用作无菌屏障,并允许从重定位护套的近端插入非无菌扩张器。
在膨胀装置以上述能够在基部护套上移位的膨胀护套的形式构造的情况下,套筒包住基部护套和膨胀护套,使得膨胀护套能够在基部护套上在基部护套和套筒之间移位。
优选地,基部护套具有直通通道,该直通通道的内径允许导管、优选地心脏泵的供应导管能够被引导通过该直通通道。为此目的,约3mm的内径是足够的。应当理解,护套的内径可以根据预期应用来调节,并且还可以与任何其它留置装置配对和操作。
优选地,护套的外径选择为足够大,使得在心脏泵插入血管时产生的血管孔眼以完全密封的方式闭合,理想地不需要致任选的动膨胀装置。考虑到目前使用的心脏泵和用于引入泵的引入护套,约3.33至5mm的外径足以用于此目的。应当理解,鉴于应用,护套的外径也可以调节,即减小或增大。但应该提及的是,在5mm以上,血管并发症发生率以指数方式增加,这就是为什么优选目标大小应在于实现止血的最小可能直径的原因。
护套的膨胀装置优选适于将护套外径在血管孔眼的区域中增加约1F至3F(0.33mm至1.00mm),优选约1F至4F(0.33mm至1.33mm),特别优选约1F至5F(0.33mm至1.66mm)。以这种方式,能够确保在不同情况下产生到血管内部的完全密封通路,特别是考虑到不同患者具有不同血管反冲可能性和血管尺寸。
除了具有正确的密封直径,同样重要的是护套的膨胀部分是“径向软的”。在本文中,径向软的意思是该部分不必像刚性部分那样起作用,而刚性部分会使血管变形和/或创伤,但该部分仍然可以限制重定位护套进入血管处的曲率/半径。这要求低硬度的聚合物材料和/或膨胀装置的特殊设计,例如螺旋缠绕的充气管(上面已经提到)。后者可以径向膨胀,但不会超过引起预弯曲部分纵向拉伸或伸展的任何切向力。
护套外径的膨胀程度由气囊的膨胀压力或可用于将膨胀限制到足以提供止血的直径的任何其他力反馈装置引导。略高于最大血压的膨胀力被认为是足够的。如果球囊材料是高柔性的,则膨胀力可以被认为等于球囊的充气压力。
根据另一优选实施例,护套包括在近端处的固定元件。所述固定元件用于在将护套插入患者的血管中之后将护套固定到患者。例如,固定元件由此能够缝合到患者的皮肤。固定元件包括用于施加无菌盖的跨越基部护套的区域。该区域在基部护套横向于基部护套的主方向的两侧上以斜坡形状向下倾斜。
固定元件的这种实施例允许简单且安全地应用无菌盖,从而使细菌和病原体在血管孔眼处的进入位置最小化。
固定元件可以另外包括在固定状态下抵靠患者皮肤的固定区域。由此,该固定区域位于上述用于施加无菌盖的区域的对面。
优选地,固定元件还包括引导元件。所述引导元件用作用于施加无菌盖的止挡。优选地,引导元件在该区域的近端上横向于基部护套的主方向并且基本上垂直于该区域地延伸,但是至少从该区域突出使得能够提供止挡的功能。通过将无菌盖施加在引导元件上并且通过用于无菌盖无皱应用的平滑区域的构造,能够获得对于伤口的特别安全和无菌的覆盖。引导元件还有助于防止重定位护套中接近固定元件的任何元件的无意固定,例如用于保护导管的近侧部免受污染的防污染套筒。
根据另一优选实施例,护套包括具有供应导管的心脏泵。护套在此适于可移动地布置在供应导管上。换句话说,心脏泵、供应导管和护套形成根据该实施例的内聚系统。
附图说明
在下文中,将参照附图通过示例来描述本发明。其中显示:
图1是根据本发明的护套的优选实施例的平面图;
图2是图1的护套的横向截面图,
图3是图1的护套及另外的任选的护套元件的立体图。
具体实施方式
图1至3中的护套10的图示不是按比例的,而是仅仅是示意性的。为了更好地示出护套10的一些元件,实际尺寸关系因此有时是不正确的。例如,锥形部分被夸大,看起来更像是倾斜的台阶,而不是从小直径到大直径的平缓和平滑过渡。
如图1和图2所示,用于产生对动物或人体的血管内部的完全密封通路的护套10包括具有管状主体的基部护套20,管状主体限定通过通道22。止血阀24(参见图3)端接护套的近端20b。
通过通道22具有内径d'和外径d。内径d'的尺寸使得护套10适于被推过心脏泵70的供应导管40(比较图3),并且优选地为约3mm。外径d优选地为约3.33mm至5mm,使得护套10适于以完全密封方式封闭在心脏泵70的引入器插入血管中时产生的血管孔眼。基于例如护套10的最小壁厚、管状主体的壁中的直通通道27(参见图2)的尺寸或供应导管40(参见图3)的尺寸,外径d可能需要大于3.33mm。
护套10包括膨胀护套26形式的膨胀装置,膨胀护套26在基部套管20上沿着血管孔眼的方向R可移位。在本示例中,膨胀护套26被构造为管状地包围基部护套20的膨胀护套26。膨胀护套26适于在基部护套20上沿方向R移位,以便当护套10已经插入到血管中时在血管的进入位置G的区域中增大护套外径d。此后,存在于血管孔眼的区域中的外径D超过初始外径d以量2x,其中2x可以大到0.75*d。
护套10包括套筒28。后者优选地在其远端紧固到基部护套20,并且此外能够在其近端紧固到固定元件60。套筒28包围基部护套20和膨胀护套26,使得膨胀护套26能够在基部护套20和套筒28之间在基部护套20上移位。以这种方式,可以防止膨胀护套26在血管上的创伤作用,并且当膨胀护套26沿着基部护套20移动到血管孔眼中以增大护套10在血管孔眼中的外径时,维持无菌性。
基部护套20的管状主体的壁25具有直通通道27。后者在壁25中从基部护套20的近端20b到远端20a延伸且与基部护套20的通过通道22分开,并且优选地平行于通过通道22延伸。根据另一个实施例(未示出),直通通道27不是在其整个长度上与通过通道22分开,而例如仅在近端上分开。在远端上,直通通道27能够形成通过通道22的侧向延伸部。直通通道27适于一旦护套10已经插入到血管中足够深时就将血液从血管(例如动脉)引导到护套10的近端。以这种方式,可以通过通道27以简单方式确定进入到血管中的足够穿刺深度。
此外,护套10可以在护套的区域中包括外部可读的标记区域,该标记区域在操作中旨在位于血管穿刺部位的区域中。外部可读性能够例如通过在该区域设置不透射线标记来实现。另外,能够使用荧光或回声物质来形成标记。根据如图2和3所示的第一实施例,该区域能够由两个限制标记29a和29b限定。这些标记还引导膨胀,并帮助定位护套相对于直通通道27的远侧开口和其血管穿刺部位的正确位置。各个标记能够例如设置在覆盖基部护套20的套筒28上和设置在基部护套20上。或者,可以通过向该区域中的护套材料添加合适的外部可读物质而基本上均匀地标记整个区域。根据这样的实施例,能够标记膨胀部分的至少一部分,例如护套的上述柔性部分和/或可拉伸部分。
下面将参考图3描述护套10的其它部件,图3以立体图示出图1的护套10。
通道27可以通过合适的连接件32、55连接到不同的测量装置,例如血压测量装置30。替代地或附加地,温度测量装置,例如热敏电阻(未示出),能够连接到或插入通道27,例如用以获得用于测量患者的心输出量的信息。
经由通道27,导丝50可以进一步插入血管中。例如,能够经由鲁尔连接器55形成到通道27的通路。
如上所述,护套10适于被推过心脏泵70的供应导管40。具有导管40的心脏泵70和护套10可以设置为内聚单元。心脏泵70优选地通过引入护套在此以上述方式引入到患者的血管系统中,引入护套用剥离技术移除,并且通过推进护套10来替换。
上述固定元件60用于在将护套插入患者的血管中之后将护套10固定(例如缝合)到患者。为此目的,可以设置开口66。固定元件60具有横跨基部护套20的区域62,用于施加无菌盖(未示出)。固定元件60的区域62在基部护套20横向于基部护套的主方向的两侧上以斜坡形状向下倾斜。此外,固定元件60包括引导元件64,引导元件64用作用于施加无菌盖的止挡。
固定元件60还可以包括循环开口67和/或循环开口槽(未示出),以便允许空气在无菌盖下方循环。这些开口或狭槽优选地在护套穿过的方向上穿过固定元件。
Claims (18)
1.一种用于产生对动物或人体的血管内部的完全密封通路的护套(10),包括:
具有管状主体的基部护套(20),所述管状主体限定通过通道(22),其中所述基部护套(20)适于通过血管孔眼插入到血管中,
其特征在于,
所述基部护套(20)的所述管状主体的壁(25)具有在所述壁(25)中从远端(20a)朝向近端(20b)延伸的直通通道(27)。
2.根据权利要求1所述的护套(10),其中所述直通通道(27)设置为独立于所述基部护套(20)的通过通道(22)。
3.根据权利要求1所述的护套(10),其中所述直通通道(27)是至少在所述远端(20a)处的、所述通过通道(22)的侧向延伸部。
4.根据权利要求1至3中任一项所述的护套(10),其中所述直通通道(27)适于将来自血管的血液传导到所述护套(10)的近端(20b)。
5.根据权利要求4所述的护套(10),包括连接到所述直通通道(27)的血压测量装置(30)。
6.根据权利要求4或5所述的护套(10),包括连接到所述直通通道(27)或者插入通过所述直通通道(27)的温度测量元件。
7.根据权利要求4至6中任一项所述的护套(10),其中所述直通通道(27)构造为使得能够通过所述直通通道(27)取得患者的血液。
8.根据权利要求1至7中任一项所述的护套(10),包括能够从所述护套的所述近端(20b)通过所述直通通道(27)被引入血管中的导丝(50)。
9.根据权利要求1至8中任一项所述的护套(10),包括膨胀装置(26),所述膨胀装置(26)适于与所述基部护套(20)配合,使得当所述护套(10)在血管中的静止位置中的情况下并且当致动所述膨胀装置(26)时,所述护套(10)的外径(d;D)在所述血管孔眼的区域中增大。
10.根据权利要求9所述的护套(10),其中所述膨胀装置(26)被构造为能够在所述基部护套(20)上在所述血管孔眼的方向(R)上移位的膨胀护套(26)。
11.根据权利要求9或10所述的护套(10),包括套筒(28),所述套筒(28)包围所述基部护套(20)和所述膨胀装置(26),使得在所述护套(10)在血管中的静止位置中,所述套筒(28)与所述血管孔眼接触。
12.根据权利要求10所述的护套(10),包括套筒(28),所述套筒(28)包围所述基部护套(20)和所述膨胀护套,使得在所述护套(10)在血管中的所述静止位置中,所述套筒(28)与所述血管孔眼接触,并且使得膨胀护套能够在所述基部护套(20)上在所述基部护套(20)和所述套筒(28)之间移位。
13.根据权利要求9至12中任一项所述的护套(10),其中所述膨胀装置(26)适于使所述护套(10)在所述血管孔眼的区域中的外径(d)增加0.33mm至1.0mm,优选0.33mm至1.33mm,特别优选0.33mm至1.66mm。
14.根据权利要求1至13中任一项所述的护套(10),其中在操作中位于血管穿孔部位的区域内的、所述护套的区域中,所述护套(10)包括外部可读标记区域(29a,29b)。
15.根据权利要求1至14中任一项所述的护套(10),包括用于将所述护套(10)固定到患者的固定元件(60),其中所述固定元件(60)具有横跨所述基部护套(20)用于施加无菌盖的区域(62),所述区域(62)在所述基部护套(20)的横向于所述基部护套的主方向的两侧上以斜坡形状向下倾斜。
16.根据权利要求15所述的护套(10),其中所述固定元件(60)包括用于施加所述无菌盖的止挡(64),所述止挡在所述区域(62)的近端上横向于所述基部护套的所述主方向延伸。
17.根据权利要求1至16中任一项所述的护套(10),包括具有供应导管(40)的心脏泵(70),其中所述护套(10)适于以可移位的方式布置在所述供应导管(40)上。
18.一种用于确定根据权利要求1至17中任一项所述的护套(10)到动物或人体的血管中的足够穿刺深度的方法,包括步骤:
将所述护套(10)通过动物或人体组织插入到血管中,达到经由直通通道(27)从血管引导血液或者血压信号在直通通道(27)的近端处能够识别的深度。
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KR102595528B1 (ko) | 2023-10-31 |
JP2020171752A (ja) | 2020-10-22 |
EP3789054A1 (en) | 2021-03-10 |
KR20230154088A (ko) | 2023-11-07 |
EP2962720A1 (en) | 2016-01-06 |
JP2023073269A (ja) | 2023-05-25 |
US20170143952A1 (en) | 2017-05-25 |
DK2962720T3 (da) | 2020-03-16 |
JP6946522B2 (ja) | 2021-10-06 |
CN106659826A (zh) | 2017-05-10 |
JP7242794B2 (ja) | 2023-03-20 |
EP2962720B1 (en) | 2020-01-15 |
JP2021184958A (ja) | 2021-12-09 |
ES2774936T3 (es) | 2020-07-23 |
CN106659826B (zh) | 2021-11-26 |
WO2016001440A1 (en) | 2016-01-07 |
KR102431113B1 (ko) | 2022-08-10 |
KR20220115819A (ko) | 2022-08-18 |
JP2017521156A (ja) | 2017-08-03 |
US20210146109A1 (en) | 2021-05-20 |
KR20170029555A (ko) | 2017-03-15 |
US10881845B2 (en) | 2021-01-05 |
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