CN102573980B - 一体式脉管输送系统 - Google Patents
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Abstract
本发明提供了一体式脉管输送系统,其具有框架,该框架构造成接纳能够在插入部位处插入患者以输送流体的导管。该框架包括第一管座、第二管座、以及一对在管座之间延伸并包括管状侧向构件的挠性侧向构件。该系统还包括与导管流体连通的流体通道,其中,所述流通道穿过管状侧向构件以及至少其中一个管座、并包括固定的转向部分,在所述固定的转向部分中,流体流动成不同于在导管内的流动方向的方向。第一管座和第二管座提供在患者上的固定点,固定点分布在插入部位周围并在导管的相对两端上,由此将框架固定至患者并稳定导管。还提供了一种用于使用一体式脉管输送系统的方法。
Description
交叉引用
本申请要求于2010年8月12日提交的美国申请No.12/855,013的优先权,并要求于2009年8月14日提交的美国临时申请No.61/233,859的权益,这些申请的全部内容通过引用合并到本文中。
技术领域
本公开总体上涉及医疗护理领域,并更具体地涉及静脉注射治疗领域中的改进的脉管输送系统。
背景技术
该部分提供与本公开有关的背景信息,该背景信息不一定是现有技术。
接受医疗的患者通常需要一种静脉注射(IV)治疗,在该静脉注射(IV)治疗中,通过患者的静脉向患者施用流体。IV治疗是将流体和药物输送到患者体内最快的方法之一。以静脉注射的方式所注入的一般包括生理盐水、药物、血液和抗生素的流体通常通过定位在若干个静脉路线——例如,外周静脉和中央静脉——中的任一个处的挠性导管输入到患者。
为了借助常规的装置和方法建立IV治疗,护理者将导管定位在选定的静脉的上方并使用导管内的针来刺入皮肤以及使导管能够插入到静脉中。导管通常定位成使得导管的远端插入端部指向患者的中线(例如,对于在胳臂上的外周IV线,导管本体定位在前臂上并指向肘)。然后,护理者将针从导管中抽出,留下导管插入在静脉中。导管的相对于导管中线的近端端部固定于导管管座的相对于患者的中线在近侧的端部。护理者通过外部管将导管连接到流体供给装置,该外部管包括延长管,该延长管通常附接于导管管座的相对于患者中线的远端端部,并且护理者通常将该延长管弯曲成U形。为了避免计划外的IV线重启动,导管和管通常借助于胶带或者类似的导管稳定装置(CSD)——例如,束缚导管本体的粘接稳定垫——紧靠于患者的皮肤。
然而,用于IV治疗的常规的装置和方法具有缺点。延长管在患者运动或者护理者操作期间会挂住附近的障碍物,这就会引起疼痛的静脉刺激以及危害IV。胶带和其他现有的CSD对稳定来说不是最优的,因为将圆形的、坚硬的以及体积大的部件——例如导管和管——紧靠于皮肤会是困难和无效的。胶带和其他现有的CSD不能够充分地防止导管在静脉内移动,这就会引起危及患者的并发症,该并发症包括导管脱出、渗漏(流体进入周围的组织而不是静脉)和静脉炎(静脉的炎症)。粘接稳定垫倾向于引起其他不期望的影响,例如由于对皮肤的延长的集中的粘着产生的皮肤刺激和/或破损。此外,胶带和现有的CSD只是将导管束缚在导管插入部位的一侧上,并且不会防止导管令人疼痛地且危险地在插入部位周围枢转以及在静脉内移动。
因此,在静脉注射治疗领域中需要创造一种克服常规的脉管输送系统的缺点中的一个或多个的、改进的脉管输送系统。本发明提供这样一种改进的脉管输送系统。
附图说明
本文中描述的附图仅为了说明选定的实施方式而非所有可能的实施,并且不是意在限制本公开的范围。
图1是优选实施方式的一体式脉管输送系统;
图2是优选实施方式的一体式脉管输送系统的半透明俯视图;
图3是另一优选实施方式的一体式脉管输送系统的半透明图;
图4A-4D是另一优选实施方式的一体式脉管输送系统的变型的半透明俯视图;
图5A-5F是用于使用优选实施方式的一体式脉管输送系统的方法的示意图;
图6A-6C分别是以用于使用优选实施方式的一体式脉管输送系统的方法来折叠的步骤的变型的俯视图、侧视图以及立体图;
在附图的若干个视图中,相应的附图标记自始至终表示相应的部件。
具体实施方式
本教导的优选实施方式的以下描述不是意在将本公开限制于这些优选实施方式,而是使本领域的技术人员能够实现以及使用本发明。
1、一体式脉管输送系统
如图1和图2所示,优选实施方式的一体式脉管输送系统100包括:框架110,框架110构造成接纳能够在插入部位处插入患者中以输送流体的导管170,其中,该框架包括第一管座120、第二管座130和一对挠性侧向构件140,该对挠性侧向构件140在管座之间延伸并包括管状的侧向构件140’;以及流体通道150,流体通道150与导管流体连通,其中,流体通道150穿过管状的侧向构件140’以及其中至少一个管座并包括固定的转向部分156,在转向部分156中,流体以与导管170内的方向不同的方向流动。第一管座和第二管座优选分别提供在患者上的第一固定点122和第二固定点132使得该固定点分布在插入部位112周围以及导管的相对两端上,由此将框架固定至患者并使导管170稳定。流体通道150的转向部分156中的流体流动优选地与导管内的流体流动相反,并且转向部分优选地固定成降低缠结或者挂住附近物体的可能性。在一个优选实施方式中,该系统包括第二管状的侧向构件140’和第二流体通道150,第二流体通道150与导管170流体连通并穿过第二管状的侧向构件140’。在优选实施方式中,框架110构造成接纳作为该系统的整体部件的导管,其中,导管170嵌在该框架的一部分中,并且更优选地嵌在其中一个管座中。然而,在替代性实施方式中,框架110构造成接纳可卡合到框架中的分离的导管。
在该系统的一些变型中,该系统还包括至少一个延长管180和/或流体供给装置适配器182,其将来自流体供给装置的流体输送到流体通道。该系统作用为允许借助所包括的导管通入接受静脉注射(IV)治疗的患者的静脉,通过导管以静脉注射的方式施用流体,并将导管牢靠并安全地稳定在患者上。该系统优选地用于施用药物、抗生素、生理盐水或者血液,但可以用于向患者施用任何适合的流体。该系统优选地用于在外周静脉上——例如在胳臂、手或者腿上——形成、稳定和保持IV线,但可替代地,该系统可以用于脖子、胸部或腹部上、或者任何适合的静脉动脉位置上的中央或者外周静脉进入。该系统还可以用于形成、稳定以及保持通入患者的任何适合的基于导管的进入,例如用于脑脊髓液的传输。
在优选实施方式中,导管170、框架110、流体通道150、延长管180和/或流体供给装置适配器182在系统的制造期间被预先组装完毕以提供符合成本效益并能够减少装配时间及包装废弃物的一体式系统。该系统优选地借助分布在插入部位112周围的固定点使导管170稳定在患者上,更优选地稳定在插入部位112的至少两个相对侧上,这可以减少或者消除在正常的患者运动和/或护理者操作期间可能发生的、令人感到疼痛的且危险的导管170的枢转运动。该系统优选地通过将导管与流体供给装置适配器对齐以及减少外部自由管而被设计成流线型,这降低系统挂到或者缠结到附近的障碍物上的可能性。该系统优选地为能够减少可能的污染和流体泄露点的封闭系统,这提高患者和护理者的安全性。该系统优选地能够与现有的常规导管插入和IV设置程序相容,这使护理者能够容易地使用该系统而不需进行很多的额外培训。
该一体式脉管输送系统的框架110作用为将该系统稳定在患者上。如图1和图2所示,框架110优选地包括:第一管座120,第一管座120位于框架的一个端部上,第一管座120提供在患者上的第一固定点122;第二管座130,第二管座130位于框架的与第一管座大致相对的端部上,第二管座130提供在患者上的第二固定点132;以及两个挠性的侧向构件140,两个挠性的侧向构件140在第一管座和第二管座之间延伸并挠性地连接第一管座和第二管座,使得第一管座和第二管座以很大的自由度相对于彼此运动。特别地,侧向构件140优选地可翻转地弯曲以将第一管座和第二管座中的一个管座折叠在另一管座之上。如图2所示,在优选实施方式中,侧向构件大致平行,使得框架110在导管170和插入部位112周围形成大致矩形的周边部分114。在框架110的变型中,该框架可以包括任何适合数量的管座以及任何适合数量的侧向构件,使得框架在插入部位112周围形成具有任何适合的形状及尺寸的周边部分114。框架110优选地例如通过在导管周围留置开放的未被覆罩的区域,使得能够看到导管的插入部位112,不过可替代地,该系统可以包括在框架上方延伸而覆罩插入部位112和/或导管170的罩,该罩是透明的、半透明的、不透明的或者是任何适合种类的材料。如图5E所示,框架优选地通过分别在位于插入部位112(优选远离和靠近插入部位)的相对两侧上且位于导管170的相对两端上的第一固定点和第二固定点处将第一管座120和第二管座130紧固到患者上而被紧固于患者,由此使导管稳定。然而,框架110可以另外地和/或可替代地通过仅紧固第一管座、第二管座、侧向构件和/或框架的任何其他适合的部位而紧固。可替代地,该框架可以在相对于导管插入部位112定位于任何适合的位置的固定点处稳定导管。当紧固于患者时,框架110使一体式脉管系统能够比仅在插入部位112的一侧上稳定导管的常规导管紧固装置更有效地稳定导管,因为在插入部位的两个相对侧上稳定导管能够减少可能在正常的患者运动和/或护理者操作期间发生的导管的枢转运动。
框架110的第一管座120作用为给框架提供第一固定点122。如图2所示,在优选实施方式中,第一管座120还作用为容置流体通道150的在第一管座内的部分。第一管座120优选地定位在框架的相对于患者的中线的近端端部,使得第一管座提供位于导管插入部位的相对于患者中线在近侧处的第一固定点122。可替代地,第一管座120可以定位在框架的相对于插入部位112的任何适合的部分上以在相对于插入部位112的任何适合的位置处提供第一固定点122。如图5E所示,第一管座120优选地借助胶带紧固于患者的皮肤,但另外地和/或可替代地,第一管座120可以借助如下紧固机构进行固定:定位在第一管座12的底面上的粘合剂;松紧带;紧固有诸如钩、钩环或者磁铁之类的紧固件的带;或者任何适合的紧固机构。第一管座可替代地可以不紧固于患者的皮肤。在一个具体的实施方式中,第一管座优选地具有相对较宽和较薄的外形,其中,宽度大约为20mm至30mm,而厚度大约为5mm。然而,第一管座可替代地可以为任何适合的形状和尺寸。大的宽度有利于将作用力分布在皮肤上的较大的区域上,这降低患者出现皮肤刺激、疮以及其他劣化的可能性。薄的外形——大约为常规的脉管进入装置的一半厚——降低管座挂到或者缠结在床设备或者附近其他的障碍物上的风险,这可能引起导管在血管内移动以及引起并发症,例如导管脱出、渗漏和静脉炎。如图1所示,第一管座120优选地具有圆形的边缘并优选地具有沿其侧向轴线略呈拱形的上表面。该拱形的上表面可以使第一管座适于沿着拱形接纳胶带以紧固于患者。第一管座可附加地具有适应患者身体的特征,例如具有下侧凹面以适应肢、手指或者关节。
第一管座120优选地由刚性或者半刚性材料——例如尼龙或者硅树脂——制成,以向框架110提供结构上的支承从而使系统稳定。然而,可替代地,第一管座可以由任何聚合物、金属、复合材料或者其他适合的材料制成。第一管座可以是透明或者半透明的以使得能够看到流体通道150。第一管座优选地通过注射成型来制造,但可替代地可以通过立体光刻、铸造、铣削或者本领域的技术人员已知的任何其他适合的制造工艺来制造。
第一管座120和/或第二管座130可以包括测量诸如患者的体温、血压或者脉搏次数之类的生物参数的传感器116。传感器116另外地和/或可替代地可以感测这种属于流体的任何适合的参数,例如PH值或者流速。
流体通道150的固定于第一管座120的部分可以联接至用于将流体从流体供给装置传输至系统的流体通道150的延长管和/或流体供给装置适配器。流体供给装置适配器优选地包括将延长管附接到流体供给装置的连接装置,该流体供给装置优选地为通过管供应流体的挂柱式IV袋,但可替代地该流体供给装置可以为注射器、泵或者其他适合的流体供给装置。如图4所示,该连接装置优选地为通常与常规的IV袋对接的标准的阴式鲁尔锁紧连接装置或者Y型连接装置,如本领域的技术人员已知的。可替代地,该连接装置可以是适于与流体供给装置对接的任何适合的阳式或者阴式连接装置。该延长管还用于在系统被推挤时提供应力消除因此优选地由诸如聚合物管之类的挠性管制成,但该延长管可以为由任何其他适合的材料制成的通路。挠性管有利于在系统突然受到干扰的情况下——例如在患者运动或者护理者操作期间——消除机械应力以及降低患者受伤的可能性。延长管优选地足够长以在需要时提供应力消除,但是足够短以降低延长管挂在或者缠结在附近的障碍物上的可能性。可替代地,延长管的长度可以为任何适合的长度,并且可以取决于系统的特定应用。流体通路的其他参数——例如,外直径和内直径——可以取决于系统的特定应用。
在该系统的替代性变型中,该系统可以包括多于一个的延长管和/或连接装置,以有助于同时从多个流体供给装置向系统输送流体。例如,在包括两个流体通道150的系统的实施方式中,该系统可包括第一延长管和第二延长管,第一延长管将第一流体输送到第一流体通道,而第二延长管将第二流体输送到第二流体通道。然而,两个延长管在涉及通过同一流体通道和导管施用两种分开的流体的应用中可以是有用的。
除下文所指出的,该系统的第二管座130优选地与第一管座120相似。第二管座130用于优选地相对于患者的中线在框架的远端端部上为框架110提供第二固定点132。第二管座优选地紧固在导管插入部位112的相对于患者中线的远侧处,在一个具体的实施方式中,其紧固成距离插入部位等于或小于大约15mm。然而,第二管座可替代地可以相对于插入部位112紧固在任何适合的位置中。如图2所示,第二管座130优选地包括自密封的隔膜134。第二管座的自密封隔膜作用为在导管插入之前为将要插入导管170中的插入针提供开口,并在于导管插入之后抽出导管内的插入针后,密封第二管座的内部通道,以防止血液以及其他潜在的生物危害物或者其他流体的泄露或者渗漏。如图2所示,隔膜134优选地定位在第二管座130的相对于患者中线的远端侧,并大致与导管170集中于一点。该隔膜优选地由自密封以形成气密密封的挠性材料制成。该自密封隔膜防止流体经第二管座的相对于患者中线的远端侧通过,从而有助于形成在针穿刺患者后血液和其他流体不会离开一体式脉管输送装置的封闭系统。隔膜134可替代地可以借助于堵塞物——例如,塞子或施加于隔膜的密封剂材料——来密封。
第二管座130在隔膜134与导管170之间还可以包括储存器。该储存器可以用作扩容室(flash chamber)以容纳在导管插入之后从导管抽出插入针的过程中的任何血液渗漏,或者可以用于任何其他适合的目的。
第二管座130还可以在第二管座130与侧向构件之间的连接处包括在将导管插入患者期间在折叠侧向构件以使其中一个管座经过另一个管座上方的时候减少侧向构件的折皱、压扁、断裂或者其他损坏的特征。作为示例,第二管座可包括沿侧向构件的自然弯曲半径构造轮廓的圆形边缘,以防止侧向构件弯曲过于剧烈或抵靠锋利的边缘弯曲。作为另一示例,第二管座可以包括解除断开部(relief cutout)和/或有助于侧向构件弯曲成其自然弯曲半径的其他加强件。
框架110的侧向构件140作用为通过使第一管座120相对于第二管座130稳定来向框架提供结构上的稳定性。如图1和图2所示,框架110优选地包括两个挠性的侧向构件,该两个挠性侧向构件包括至少一个管状的侧向构件140’。然而,在该框架的替代性变型中,该框架可以包括更少或者更多的侧向构件。侧向构件优选地向框架提供结构上的稳定性,并且该一个或更多个管状侧向构件140’优选地容置流体通道150的一部分。侧向构件优选地彼此平行并且优选地在第一管座与第二管座之间延伸,以在导管170的周围形成周边部分114。然而,侧向构件可以成任意交叉的、非平行的或者任何适合的定向。侧向构件优选地使第一管座和第二管座能够以大的自由度相对于彼此运动,其中包括沿着导管的轴线在压缩方向上的位移(继而在拉伸方向上的位移)、沿着另外两个轴线在双方向上的位移、沿着导管的轴线在双方向上的扭转以及沿着另外两个轴线在双方向上的弯曲。特别地,侧向构件优选能够翻转地弯曲,以将第一管座和第二管座中的一个折叠在另一个之上。如图5B和图6所示,在将导管插入患者的过程中,侧向构件优选地被折叠成将第一管座120折叠在第二管座130之上,这使导管周围的周边部分114开放以及使导管的穿刺末端露出。侧向构件的长度优选地比导管长大约30%到50%,但可替代地可以依据特定的应用而更短或者更长。至少一个侧向构件140可以包括刻度,例如与尺子上的刻度相似的刻度,以指示导管插入患者的深度。侧向构件优选地由挠性聚合物挤制而成,被定长切割并模制到一个或两个管座上,但可替代地,侧向构件可以通过任何适合的制造工艺和/或由任何适合的材料制成。
在第一优选实施方式中,成对的侧向构件包括管状的侧向构件140’和实心的侧向构件140”。该管状的侧向构件优选地为大致直的、柔软且挠性的中空通道,例如医用管,但可替代地,该管状的侧向构件可以为具有内部流体通路的、容置流体通道150的一部分的任何适合的结构。管状的侧向构件优选地足够刚硬以给框架110提供结构上的支承,但又足够挠性以在导管的插入过程中在其整个长度上弯曲和折叠而不会损坏。管状的侧向构件可以包括增强弯曲而不损坏的能力的附加的特征。例如,管状的侧向构件可以沿着其长度渐窄以及在第二管座130处的弯曲应力点附近包括较厚的壁和/或较大的外直径。又例如,管状的侧向构件可以具有更耐抗弯曲损坏的椭圆形横截面。再例如,第一侧向构件的至少一部分可以与手风琴类似地包括可伸长并且可折叠的褶,从而允许侧向构件的具有较少弯曲应力的弯曲。
如图2所示,在第一优选实施方式中,实心的侧向构件优选地与第一侧向构件在形状和尺寸上相似,使得框架110在结构上是对称的,但实心的侧向构件优选地为“虚拟的”结构,因为其不容置流体通道150的一部分。实心的侧向构件140”优选地在挠性以及强度方面与管状的侧向构件140’大致相同。然而,实心的侧向构件140”可替代地可以具有不同的形状(例如,更大的直径或者更大的厚度),以进一步增强第一管座120相对于第二管座的稳定性。与管状的侧向构件140’相似,实心的侧向构件140”还可以包括增强弯曲而不损坏的能力的特征。
如图3所示,在第二优选实施方式中,成对的侧向构件包括两个管状的侧向构件140’,这两个管状的侧向构件140’与第一优选实施方式的管状的侧向构件相似。在该实施方式中,管状的侧向构件140’优选地为相同的并且容置有在管座之间引导第一流体流动和第二流体流动的两个独立的流体通道。然而,管状的侧向构件可替代地可以是不同的以用于不同的目的。例如,两个管状的侧向构件140’可以容置适于运载不同类型(例如,不同密度)的流体的两个独立的流体通道,并且两个管状的侧向构件可以具有不同的壁厚以对不同的流体进行补偿从而实现框架的结构对称。再例如,管状侧向构件可以具有不同尺寸的腔。
在一些替代性变型中,框架110可以包括管状侧向构件和实心侧向构件以任何适合的方式组合和排列的少于两个或者多于两个的侧向构件。所有侧向构件可以是实心的、管状的或者中空的或者它们的任何组合。在一些替代性变型中,侧向构件可以在上游和/或下游合并和/或分支。例如,在一个替代性实施方式中,侧向构件可以包括薄挠性板的在靠近和远离插入部位处合并的多个部分,使得导管的尖端穿过合并的部分之间的槽状开口。
该系统的流体通道150作用为向导管输送来自流体供给装置的流体,以及在一些实施方式中,输送流体进出导管。流体通道150可另外地和/或可替代地输送流体离开导管170,例如将从患者取出的流体通过导管170传输到外部储存器。如图2所示,流体通道150优选地包括固定在其中至少一个管座内和/或固定在管状侧向构件140’内的至少一部分。更优选地,流体通道150包括:第一部分152,第一部分152固定在第一管座120内;第二部分154,第二部分154穿过管状的侧向构件140’;以及转向部分156,转向部分156固定在第二管座130内。在第一变型中,流体通道150可以是连续的长度,例如,固定在第一管座中、穿过或者充当管状侧向构件140’、固定在第二管座130中并且流体联接至导管的一体式管。在第二变型中,流体通道150包括分离的长度,例如在不同点处例如通过热封、其他塑料焊接方法或者流控联接器结合的分离的管节段。在第三变型中,流体通道150在一个或两个管座内包括管状的腔,管状节段通过类似于第二变型的方法结合于该管状的腔。在第三变型中,在第一管座和/或第二管座中的管状的腔可以通过模制成型、钻孔、激光切削或者以任何适合的制造工艺来形成。在第四变型中,流体通道150可以在管座和侧向构件中的一个或多个的外部,使得流体通道的至少一部分安装于管座或者侧向构件的外部并从其上方通过。流体通道的其他变型包括这些变型的每种排列和组合。
如图2所示,流体通道150的第一部分152优选地包括:入口,该入口相对于患者的中线定位在第一管座的近侧的中线处;以及出口,该出口相对于患者的中线定位在第一管座的远端侧上。然而,内部通道的入口和出口可以定位在第一管座上的任何适合的位置上。流体通道150的第一部分的入口优选地从延长管180接收流体,而内部通道的出口优选地将流体输送到框架110的侧向构件中的至少一个,但流体可替代地可以以相反的顺序流动。流体通道150的第一部分优选地包括直角部以将来自第一管座的中线的流体引导至定位在框架侧部上的管状的侧向构件140’。然而,流体通道的第一部分可替代地可以是弯曲的(如图3和图4所示)、曲线的或者用于流体流动通过第一管座120到达侧向构件的任何适合的形状。流体通道的第一部分可以通过将延长管插入第一管座中的、与流体通道对齐的中空凹部中并借助于环氧树脂密封凹部的边缘而连接于延长管,但第一管座可替代地可以通过将延长管压配合到第一管座中的凹部中、借助于环氧树脂密封对接接头、或者任意适合的联接方法而联接至延长管。
如图2所示,流体通道150的第二部分154优选地在第一管座120中的第一部分与第二管座130中的转向部分156之间穿过管状的侧向部分。
如图2所示,流体通道150的转向部分156优选地固定成在与导管170内的流体流动不同的方向上引导流体流动。转向部分优选地将流体流动引导到与导管内的流体流动相反的方向上,或者以大约180度的转弯引导流体流动。转向部分156可以包括直角、椭圆形或者圆形的转弯。流体通道的转向部分优选地固定或者嵌入在第二管座130内(相对于患者中线的远侧)。由于导管通常插入在患者体内使得其刺入端接近于指向患者的心脏,所以内部通道内的流体流动的大约180度转弯使延长管能够设置在插入部位112的相对于患者中线的近侧。流体供给通道的这种定位有利地使支承IV袋或者其他流体供给装置的支架能够保持靠近床头或者另外地保持在插入部位的相对于患者中线的近侧,如在患者治疗环境中通常需要和实施的那样。在流体通道150的转向部分中的内在化的流体流动转向也是有利的,因为其减少会被钩挂或者缠结在附近的障碍物上并影响IV设立的外部特征。转向部分的另一效果是:如果延长管和/或来自流体供给装置的另外的管被拉拽或挂住,则转向部分可以使框架能够通过导致导管被进一步地拉向患者体内而更有效地稳定导管。例如,在导管安放在前臂上并且其末端大致指向患者的肘弯的常见导管安放中,如果延长管被意外地朝着患者向后拉动,则管又会在向后的方向上拉动流体通道的转向部分以及远侧的第二管座130,由此将导管末端向近侧拉从而进一步进入患者的血管中。
如图3-4所示,在另一优选实施方式中,该系统包括第二流体通道150,第二流体通道150优选地与第一流体通道150相似,但可替代地,第二流体通道150可以为第一流体通道150的变型中的任一种。第二流体通道优选地穿过第二管状的侧向构件140’。第二流体通道优选地接纳第二流体,该第二流体可以与被供应至第一流体通道的第一流体相同或者不同。如图4A-4C所示,在该实施方式中,该系统还可包括第二延长管180,第二延长管180向第二流体通道供应第二流体。然而,如图4D所示,该系统可以只包括一个延长管,该一个延长管向一个或者两个流体通道供应流体。这些流体通道可以在第一管座上具有单独的入口或者可以在第一管座上共用同一入口,在该同一入口中,可以借助阀或者其他流体控制装置来调节流动。在一个变型中,第一流体通道和第二流体通道优选地在第二管座130中与同一导管流体连通,在沿着导管长度的相同部位(图4D)或者不同部位(图4C)处联接至导管。在该变型中,系统优选地包括流动控制系统160,流动控制系统160选择性地限制其中一个流体或这两个流体到导管进而到患者的流动。流动控制系统可以包括例如在延长管处(图4A-4B)、在与导管170的接头处(图4C-4D)或者在任何适合的位置处的一个或更多个阀162。流动控制系统162另外地和/或可替代地可以使用降压装置、排流装置或者任何适合的技术以对流体通道和导管中的流体流动进行控制。流动控制系统162还可以存在于仅包括一个流体通道的实施方式中。在另一变型中,第一流体通道和第二流体通道优选地与具有双腔的导管流体连通,使得一个导管腔联接至第一流体通道,而另一导管腔联接至第二流体通道。在又一变型中,第一流体通道和第二流体通道与分离的导管流体连通。其他的变型在这些变型的基础上扩展成具有三个或更多个流体通道。
另外,第一管座120和/或第二管座130可以包括在下游合并的多个内部通道,使得在管座中入口的数量大于出口的数量。在一些变型中,管座中的一个可以包括一个或更多个在下游分支的内部通道,使得入口的数量小于出口的数量。管座中的一个可以包括一个或更多个在第一管座内既分支又合并的内部通道。多个内部通道可以将流体输送到多个导管或者一个导管的多个腔。
在一些实施方式中,该系统还包括近端部分嵌入在框架的一部分中的导管170,并且更优选地,嵌入在第一管座或者第二管座130中。一体式脉管系统的导管170作用为将用于IV治疗的流体施用到患者。导管170优选地为能够插入患者的血管中的管道,但可以为任何适合类型的导管。如图1-4所示,导管优选地流体连接于流体通道的转向部分,并相对于患者的中线定位在第二管座130的近侧的中线处。导管170优选地与延长管对齐,这使会挂到或缠结到附近障碍物上的附加外部管和其他连接减少并成流线型,对于患者来说附加外部管和其他连接挂到或缠结到附近障碍物上是令人感到疼痛的并且是危险的。然而,导管可以定位在第二管座上的任何适合的位置处。在一些实施方式中,导管可以定位成其近端端部指向并流体连接到第一、更近端管座,使得系统缺少流体通道的转向部分。例如,导管可以流体地连接于更接近患者的第一管座。导管优选地由柔软挠性的聚合物制成,但也可以由任何适合的材料制成。导管的尺寸——包括长度、直径和套管尺寸——取决于特定的应用。导管是本领域已知并且使用的,例如,在名称为“Vascular accesscatheter and methods for manufacture thereof”(脉管进入导管及其制造方法)的美国专利No.5,358,493中描述的导管,该项专利的全部内容通过引用合并到本文中。导管可以沿着其长度包括刻度,例如类似于尺子的刻度,以指示导管插入到患者体内的深度。
2、使用一体式脉管输送系统的方法
如图5A-5F所示,一体式脉管输送系统的方法200优选地包括如下步骤:提供形成周边部分的框架S210,其中,该框架构造成接纳远端端部被包围在该周边部分内的导管,并且该框架包括第一管座、第二管座和流体通道;折叠框架以改变框架的周边部分S220,由此使导管的远端端部不受框架的周边部分的约束;在插入部位处将导管插入到患者体内S230;将框架展开以使框架的周边部分恢复围绕导管的远端端部和插入部位S240;在分布在插入部位周围的多个固定点处将框架紧固到患者S250,由此使导管相对于插入部位保持稳定;以及使流体能够在导管与患者之间流动S260。可以执行方法200以实现进入患者——例如,接受静脉注射治疗的患者——的血管。该方法可以用于向患者施用药物、抗生素、生理盐水、血液或者任何适合的流体,和/或从患者取走流体。该方法可以用于在例如胳臂、手或者腿上的外周静脉或者动脉上的插入部位处形成、稳定以及保持IV线,或者用于脖子、胸部或者腹部或者任何适合的IV位置上的中央静脉进入。进一步地,该方法可用于形成、稳定和保持对患者的任何适合的基于导管的进入,例如用于脑脊髓液的传输的导管。
如图5A所示,提供的步骤框架S210包括提供一体式脉管输送系统,例如上文所描述的一体式脉管输送系统。然而,一体式脉管输送系统可替代地可以为具有框架、第一管座和第二管座以及流体通道并且框架能够折叠以将第一管座朝向第二管座移位的任何适合的系统。例如,形成周边部分的框架可以包括借助铰接接头联接的第一管座和第二管座。另外,一体式脉管输送系统可以包括更少或者更多的管座。
折叠框架的步骤S220作用为使导管的可插入端部露出并为待定位于插入部位处的导管提供视觉净空以及进入插入部位的物理净空。如图5B和图6A所示,折叠框架的步骤优选地包括沿第一方向使框架的第一管座从框架的第二管座的上方越过。框架的第一管座优选地为框架的、相对于患者中线的近端部分,而框架的第二管座优选地为框架的、相对于患者中线的远端部分,但第一管座和第二管座可以为框架的任何适合的部分。例如,如图5F所示,相对于在患者肘弯处的插入部位,第一管座优选地接近肘,而第二管座优选地接近手,使得折叠框架的步骤将第一管座远离患者并且通常朝向站在患者前面使用该系统的护理者折叠。
在插入部位处将导管插入患者的步骤S230包括:将针插入导管中,借助针刺入插入部位,将导管定位在插入部位内,并从导管中抽出针。将导管插入患者的步骤作用为形成能够经其将流体施用至患者的管道。执行借助针刺入插入部位的步骤时,针优选地相对于患者的中线指向近侧。将针插入到导管中的步骤优选地包括将针穿过框架的第二管座插入,这样引入适于刺入插入部位以便导管插入的穿刺工具。刺入插入部位、定位导管以及取出针的步骤是本领域技术人员已知并使用的。如图5C所示,在第一变型中,将针插入通过导管包括使针从框架的第一管座上方越过并且穿过导管S232,这在导管插入期间保持框架的折叠定向并有助于将第一管座保持在适当位置以防止第一管座妨碍针进入第二管座。如图6A-6C所示,在第二变型中,将针插入通过导管包括使针从框架的第一管座的下方经过并穿过导管S234。在该第二变型中,第一管座优选地安置在例如针座的附加机构中或者联接至该附加机构。
将框架展开的步骤S240作用为将框架的周边部分回复成围绕导管的远端端部和插入部位。如图5D所示,将框架展开的步骤优选地包括沿第二方向使框架的第一管座从框架的第二管座的上方越过。第二方向优选地与第一方向相反,但可替代地,第二方向可以为任何适合的方向并使框架的周边部分恢复围绕插入部位。从导管中抽出针的步骤有助于将框架展开的步骤,因为与第一管座联接的针或者其他机构不再存在而将第一管座保持就位。
在插入部位周围的多个固定点处将框架紧固到患者的步骤S250作用为使导管相对于插入部位保持稳定。如图5E所示,将框架紧固到患者的步骤包括在邻近插入部位的第一固定点处将框架的第一管座紧固到患者,以及在插入部位对面与第一固定点相对的第二固定点处将框架的第二管座紧固到患者。多个固定点优选地包括彼此大致相对的至少两个固定点,并更优选地包括大致均等地分布在插入部位周围的固定点。特别地,第一固定点优选地相对于患者在插入部位的远侧,而第二固定点优选地相对于患者在插入部位近侧。在插入部位的两个相反侧上将框架紧固到患者作用为有效地减少或者消除导管的在静脉内的运动,从而减少或者消除疼痛和危机患者的并发症的发生,这些并发症包括导管脱出、渗漏和静脉炎。在一些变型中,紧固框架的步骤包括在一个固定点处或者三个或更多个固定点处紧固任何适合数量的管座。第一固定点优选地在插入部位的相对于患者中线的近侧,而第二固定点优选地在插入部位的相对于患者中线的远侧,但第一固定点和第二固定点可以相对于插入部位在任何适合的位置处。每个紧固步骤可以包括用胶带将框架缚到患者、借助粘合剂将框架粘合到患者、将框架捆扎到患者,或者任何适合的紧固机理。
使流体能够在导管与患者之间流动的步骤S260作用为向患者施用流体和/或从患者取走流体。如图5F所示,使流体能够流动的步骤优选地包括将流体通道连接到流体供给装置或者储存器。流体通道如本领域众所周知的优选通过将流体通道与延长管流体连接而连接到流体供给装置或者储存器,但可替代地,流体通道可以通过借助任何适合的方法连接框架的任何适合的部分而连接至流体供给装置。该流体供给装置优选地为IV袋,但可替代地可以为任何适合的流体供给装置。在一体式脉管输送系统包括多个流体通道的一些变型中,使流体能够流动的步骤包括将第二流体通道连接到第二流体供给装置或者储存器。
该方法还可包括在插入部位和框架上施加包扎用品。施加包扎用品的步骤作用为保护插入部位不受细菌、病毒和其他病菌的影响。包扎用品优选地为本领域技术人员已知并使用的透气无菌包扎用品,例如Tegaderm。如图5F所示,包扎用品优选地为透明的以允许看到插入部位,并包括粘合剂以附接到患者的皮肤以及提供对框架的紧固。然而,包扎用品能够包括任何适合的装置或者方法以有助于保护插入部位。
根据之前的详细的描述以及根据附图和权利要求,本领域的技术人员将会认识到,在不脱离由所附的权利要求限定的本发明的范围的情况下,能够对本发明的优选实施方式进行修改和改型。
Claims (20)
1.一种适于围绕插入部位安放在患者身上的一体式脉管输送系统,包括:
框架,所述框架构造成接纳能够在所述插入部位处插入患者体内以传输流体的导管,其中,所述框架包括:
第一管座,所述第一管座提供在患者身上的第一固定点;
第二管座,所述第二管座提供在患者身上的第二固定点;以及
一对挠性的侧向构件,其中,所述一对挠性的侧向构件包括第一管状侧向构件,所述第一管状侧向构件在所述第一和第二管座之间延伸,并且,所述一对挠性的侧向构件构造成与所述导管隔开;
其中,所述第一固定点和所述第二固定点分布在所述插入部位周围以将所述框架固定至患者,由此稳定所述导管;以及
第一流体通道,所述第一流体通道与所述导管流体连通,其中,所述第一流体通道穿过所述第一管状侧向构件以及所述第一和第二管座中的至少一个管座,并且,所述第一流体通道包括固定的转向部分,在所述固定的转向部分中,第一流体流动成与在所述导管内的流动方向不同的方向。
2.根据权利要求1所述的系统,其中,所述系统进一步包括所述导管,并且,相对于所述导管,所述导管的近端部分嵌入在所述框架的一部分中。
3.根据权利要求2所述的系统,其中,所述导管的所述近端部分嵌入在所述第一管座或者所述第二管座中。
4.根据权利要求1所述的系统,其中,相对于所述患者,所述第一固定点位于所述插入部位的远侧,而所述第二固定点位于所述插入部位的近侧。
5.根据权利要求1所述的系统,其中,所述一对挠性的侧向构件能够可翻转地弯曲,以将所述第一管座和所述第二管座中的一个管座折叠在另一个管座之上。
6.根据权利要求5所述的系统,其中,所述一对挠性的侧向构件基本上平行,使得所述框架围绕所述插入部位形成大致矩形的周边部分。
7.根据权利要求1所述的系统,其中,所述第一流体通道的所述转向部分固定在所述第一和第二管座中的一个管座内。
8.根据权利要求7所述的系统,其中,所述第一流体通道的所述转向部分将流体流动沿与所述导管内的流体流动相反的方向引导。
9.根据权利要求1所述的系统,其中,所述第一和第二管座中的至少一个管座包括测量生物学参数或者流体参数的传感器。
10.根据权利要求1所述的系统,其中,所述一对挠性的侧向构件包括实心侧向构件。
11.根据权利要求1所述的系统,其中,所述一对挠性的侧向构件包括第二管状侧向构件,其中,所述系统进一步包括第二流体通道,所述第二流体通道与所述导管流体连通并穿过所述第二管状侧向构件以及所述第一和第二管座中的至少一个管座。
12.根据权利要求11所述的系统,其中,所述第二流体通道接纳第二流体。
13.根据权利要求12所述的系统,其中,所述第二流体与所述第一流体不同。
14.根据权利要求12所述的系统,其中,所述系统包括第一延长管和联接至所述第二流体通道的第二延长管,所述第一延长管将所述第一流体输送至所述第一流体通道,所述第二延长管将所述第二流体输送至所述第二流体通道。
15.根据权利要求1所述的系统,进一步包括流动控制系统,所述流动控制系统选择性地限制流体通过所述导管的流动。
16.根据权利要求15所述的系统,其中,所述流动控制系统包括至少一个阀。
17.根据权利要求11所述的系统,其中,所述导管为包括第一腔和第二腔的双腔导管,所述第一腔联接至所述第一流体通道,所述第二腔联接至所述第二流体通道。
18.一种适于安放在患者身上的一体式脉管输送系统,包括:
导管,所述导管具有接收流体的近端端部和在插入部位处将所述流体输送给患者的远端端部;
框架,所述框架提供围绕所述插入部位的大致矩形的周边部分,所述框架包括:
第一管座,所述第一管座提供在患者身上的第一固定点;
第二管座,所述第二管座提供在患者身上的第二固定点;以及
一对挠性的侧向构件,其中,所述一对挠性的侧向构件包括第一管状侧向构件,所述第一管状侧向构件在所述第一和第二管座之间延伸,并且,所述一对挠性的侧向构件构造成在所述导管的相对两侧上与所述导管隔开;
其中,所述第一固定点和所述第二固定点位于所述插入部位的相对侧上以将所述框架固定至患者,由此稳定所述导管;
其中,所述一对挠性的侧向构件能够可翻转地弯曲,从而将所述第一管座和所述第二管座中的一个管座折叠在另一个管座之上;以及
第一流体通道,所述第一流体通道与所述导管流体连通,其中,所述第一流体通道穿过所述第一管状侧向构件以及所述第一和第二管座中的至少一个管座,并且所述第一流体通道包括固定的转向部分,在所述固定的转向部分中,流体流动成与在所述导管内的流动方向相反的方向。
19.根据权利要求18所述的系统,其中,所述一对挠性的侧向构件包括实心侧向构件。
20.根据权利要求18所述的系统,其中,所述一对挠性的侧向构件包括第二管状侧向构件,其中,所述系统进一步包括第二流体通道,所述第二流体通道与所述导管流体连通并穿过所述第二管状侧向构件以及所述第一和第二管座中的至少一个管座。
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CN102573980A (zh) | 2012-07-11 |
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