CN100571627C - 回流式血液采集针 - Google Patents

回流式血液采集针 Download PDF

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CN100571627C
CN100571627C CNB2004800440754A CN200480044075A CN100571627C CN 100571627 C CN100571627 C CN 100571627C CN B2004800440754 A CNB2004800440754 A CN B2004800440754A CN 200480044075 A CN200480044075 A CN 200480044075A CN 100571627 C CN100571627 C CN 100571627C
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A·陈子龙
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Becton Dickinson and Co
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154—Devices using pre-evacuated means
    • A61B5/1545—Devices using pre-evacuated means comprising means for indicating vein or arterial entry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150213—Venting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150221—Valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150473—Double-ended needles, e.g. used with pre-evacuated sampling tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0693—Flashback chambers
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S604/00—Surgery
    • Y10S604/90—Telltale showing entry of blood into body inserted conduit

Abstract

一种针组件，包括透明或者半透明的外壳，所述外壳具有流体入口端、流体出口端以及在它们之间的回流腔室和通气机构。基本上在轴向上对准的入口插管和出口插管从外壳延伸并与腔室连通。可密封的套筒覆盖了出口插管的外部末端。在回流腔室出口上的内通气孔塞，将插管、腔室和套筒的相对体积选择成提供静脉进入的快速而可靠的回流指示，且回流腔室的出口上的内部通气塞在从患者身上抽回针时可以抑制血液的泄漏。

Description

回流式血液采集针
技术领域
本发明涉及一种装置，所述装置用于通过对患者进行静脉穿刺来采集血液样品。更具体地说，本发明涉及一种用于多次样品血液采集的针组件，所述针组件能使抽血者确定当从患者身上采集血液样品到抽空的血液采集管中时静脉进入是否发生。
背景技术
静脉穿刺是用于获得实验室试验用血液样品的主要方法。在进行静脉穿刺操作时，抽血者必须同时遵守几个步骤。这些步骤包括评估患者的总体身体和心理状态，以便适当地选择静脉穿刺的部位和技术。抽血者还必须选择适当的相应设备、实施技术，以便控制出血，并适当地采集和识别供试验用的流体样品。抽血者必须确定所有这些相符的因素，因为这些因素可能严重地影响静脉的膨胀和静脉穿刺操作的时间长度。
为了解决上述问题，已经研制出各种静脉穿刺装置。这些装置包括那些可以帮助抽血者确定已经完成静脉进入的产品，见例如美国专利5,222,502和5,303,713。这种装置包括带有外壳的针组件，上述外壳在其中限定有腔室。将两端尖锐的插管固定到外壳上，插管的静脉内端(IV)适合用于穿透患者的静脉。插管的非患者端具有一可密封的套筒，并适合于穿透位于一抽空的容器内的可穿透塞子。
在用插管的静脉内端进行静脉进入时，血液将穿过插管流入可密封的套筒并流入外壳腔室，上述外壳腔室是透明或半透明的以用于目测(“回流”)。一旦空气从回流腔室中排出，在致动抽空的容器时，每次把可密封的套筒推向外壳腔室时，其中的血液就被加压。
由于静脉进入和回流之间的这段时间，抽血者可能错误地认为，因为在看穿腔室中没有静脉进入的立即指示，所以没有达到令人满意的静脉进入。因此，抽血者可能不必要地重复静脉穿刺操作，同时要求更换抽空的容器和/或针组件本身。这种重复性过程延长了患者所忍受的身体和感情的不适。在这些情况下，抽血者可以使用一种血液采集装置，以便提供某种进入指示，因而将导致血液采集装置的费用以及废弃管的费用。
因此，理想的情况是提供一种改良的血液采集装置，所述血液采集装置使血液能通过相对较短的针直接流到回流腔室，从而提供成功的静脉进入的直接指示。
发明内容
本发明提供一种针组件，所述针组件用于提取出至少一种流体样品到抽空的容器中用于实验室试验。针组件提供透明或半透明的外壳，所述外壳具有足够的死空间供血液流入回流腔室，以便使用者通过目测来证实成功的静脉进入；所述外壳还具有在回流腔室出口上的内部通气机构，以便从患者身上抽回IV针时可以抑制血液的泄漏。这里所使用的通气机构表示一种或者更多的特征或元件，所述特征或元件用来提供通气，但是其通常阻止流体通过。在通气机构中进行通气的实际元件可以是例如通气孔塞或单向阀。同时，由于通气机构将血液保留在相对小的回流腔室内，所以使用后在外壳内只有非常少的残余血液。
根据本发明的针组件包括外壳，所述外壳依次包括外壳内部、与外壳内部连通的回流腔室、以及(i)安装在外壳中与回流腔室相通的第一插管和安装在外壳中与回流腔室相通的第二插管，或者(ii)安装在外壳中具有与回流腔室相通的开口的单个插管。将这些元件构造成使得外壳内部和外部环境之间的唯一连通通路经由回流腔室。通气机构位于回流腔室和外壳内部之间的连通通路上，这样，当与血液接触时，所述通气机构密封，防止空气从外壳内部流到回流腔室。
使用时，静脉内端(IV)插管(或单个插管的IV部分)刺破患者的皮肤进入静脉。在进行令人满意的静脉进入时，由于静脉压力的影响，在IV插管内腔、回流腔室、外壳内部和非患者插管(或单个插管的非患者部分)的内腔中的处于大气压下的空气受到压缩，并因此流过IV插管进入回流腔室，并通过通气孔塞进入外壳内部。由于在回流腔室内的静脉压力超过大气压，血液流入腔室中。尽管通气机构允许空气流过，但是其阻止血液流到外壳内部，这样在与血液的接触时密封，因而将处于静脉压力的压缩空气滞留在外壳内部中。这就使得从患者身上抽出IV插管时，可以抑制血液或流体样品的泄漏，否则泄漏可能由于空气从外壳内部通过IV插管解压而发生。
穿过插管的内腔、腔室、外壳内部和套筒所限定的体积被选择成可以非常快速地指示静脉进入。第一和第二插管通常在轴向上相互对准，以便在它们之间沿着外壳的长度提供轴向的流体流动路线。第二插管通常包括可密封的套筒。
附图说明
图1是本发明的针组件的典型实施例的横截面视图。
图2是第二实施例的横截面视图。
图3是第三实施例的横截面视图。
图4是第四实施例的横截面视图。
图5是图1的针组件使用之前的示意图。
图6是与图5类似的示意图，但是示出了静脉进入的第一标志。
图7是第五实施例的示意图。
具体实施方式
本发明提供一种用于血液采集的针组件，所述针组件在将患者的血液或其它流体样品采集到单个或者多个抽空的血液采集管中时，提供静脉进入的一种视觉指示(回流)，并且在从患者身上取下IV插管时可以抑制血液或流体样品的泄漏。
图1-7列出了本发明的不同实施例，参考图1，该实施例针对一种针组件210，所述针组件210带有外壳212，该外壳212具有流体入口端214、流体出口端216和在所述两端之间延伸的截头形外壁218。外壁218限定了外壳内部220。外壳212还包括圆柱形内壁224，所述内壁224在外壳内部220中基本与圆柱形外壁218同心地从流体入口端214延伸到通气孔塞900。圆柱形内壁224和通气孔塞900限定了回流腔室226。
针组件210还包括流体入口插管236，所述入口插管236具有外端和内端244，上述外端限定了变尖的斜面，而上述内端244固定地安装在外壳212的流体入口端214中。流体入口插管236的特征在于，基本上为圆柱形的内腔在所述两端之间延伸，并与外壳212的内部相通。
针组件210还包括流体出口插管252。出口插管252包括钝头的内端254、外端以及基本上是圆柱形的内腔，上述外端限定变尖的斜面，而上述圆柱形内腔在上述两端之间延伸。出口插管252在两端之间的部分牢牢固定在外壳212的出口端216中。出口插管252如此安装，使得内端254基本上同轴地进入内壁224中，并且使得出口插管252的内端254基本上在轴向上与入口插管236的内端244对准。另外，出口插管252的内端254与入口插管236的内端244仅仅间隔一段很小的距离。出口插管252的内端254与入口插管236的内端244之间的轴向间隙小于0.5mm可能造成不稳定的回流。
圆柱形内壁224相对于出口插管252的尺寸定成能够实现所希望的血液流过组件210，并且获得有效的回流指示。尤其是，圆柱形内壁224的尺寸优选地定成在出口插管252周围提供约0.2mm的径向间隙，如图1中尺寸“c”所表示的。这种间隙实现了回流腔室226内基本上层流的血液流动，并防止血液的溶血现象。此外，圆柱形内壁224与出口插管252之间的小径向间隙能使一滴血很薄地蔓延在回流腔室226中的径向间隙上，以便用很小体积的血液提供放大的回流指示。因此，在血液初次从入口插管236的内端244出现时，可以迅速获得很容易看到的回流指示。
针组件210还包括可密封的套筒261，所述套筒261安装在外壳212的流体出口端216上，并且当可密封的套筒261处于未偏压状态时，套筒261覆盖出口插管252的外端258。然而，可密封的套筒261可以随着抽空的管子270的塞子272所施加的压力而塌陷，用于推动出口插管252的外端260通过可密封的套筒261和抽空的管子的塞子，如本领域已知的那样。
上述实施例是根据通气孔塞描述的。然而，任何通气机构都是合适的。例如，通气机构可以是多孔的通气孔塞，所述通气孔塞由基体或载体材料形成，所述材料通常是疏水材料，这些材料涂有、浸渍有或者用其它方式含有亲水材料，所述亲水材料与水溶的或含水的物质接触时会发生膨胀。疏水载体材料可以是高密度聚乙烯、聚四氟乙烯、超高分子量聚乙烯、尼龙6、聚丙烯、聚偏二氟乙烯和聚醚砜，但是并不局限与此。因此，与血液接触时，亲水材料的可膨胀特性在通气装置中提供密封功能。也可以使用这样一种多孔通气孔塞，其通过生物学现象，例如，阻塞通气的血液凝结和/或细胞凝集，在与血液接触时被密封；也可以使用超吸收材料，通过其接触含水流体时产生的膨胀来密封通气装置；或者使用单向阀(例如，薄瓣，如覆盖着通气装置的塑料膜；可变形的密封件，如橡胶或者塑料鸭嘴形阀；或者通气装置上可变形的包装)。应当指出，还可以对这些不同的机构进行任意组合。
图2-4显示了具有不同通气孔塞的实施例。图2显示了一种通气孔塞900a，所述通气孔塞900a位于圆柱形内壁224a的端部处，并且安装在外壳内部非患者壁300的凹槽301内。图3显示了一种通气孔塞900b，其安装位置与图2中的相似，但是通气孔塞900b具有凸肩901b。图4显示了一种通气孔塞900c，所述通气孔塞900c位于圆柱形内壁224c内以及外壳内部非患者壁300的凹槽301内。每个实施例中的通气孔塞使得没有空气在不经过通气机构(900a、b、c)的情况下可以从回流腔室226流到外壳内部220。
图5和6提供了图1的针组件210在常规的静脉穿刺之前和之后的示意图。穿刺期间，针组件210连接至夹持器(未显示)，并刺穿患者皮肤以进入静脉。静脉进入时，血液进入IV插管236，并流向回流腔室226。血液从入口插管236流进入口插管和出口插管之间的空间，这样，血液就既流进出口插管252又流进回流腔室226。此时，回流腔室指示成功的静脉进入，并减少了图6所示的外壳212中存在的空气体积。静脉进入之前，在IV插管的内腔248、回流腔室226、外壳内部220和非患者插管262的内腔内，空气处于大气压下。因此，这些大气压下的空气由于静脉压力的影响而经受压缩，所以迫使这些空气通过图6所示的IV插管236进入回流腔室226，并通过通气孔塞进入腔室220。通气孔塞900阻止血液流进外壳内部220，所述通气孔塞允许加压空气流过，但是在与血液接触时通气孔塞就被密封，因此，将加压空气(处于静脉压力)滞留在外壳内部220。一旦腔室226内的压力和静脉压力相等，血液在整个针组件中的流动就停止了。
一旦进行了前面几段所介绍的步骤，并且抽血者目测证实了静脉进入，则把抽空的容器(未显示)插入夹持器中，以使第二插管252的外端260刺穿容器的塞子272，如本领域所熟知的一样。在第二插管252刺穿塞子时，负压梯度被传送到腔室226，这使得血液从腔室226流入容器。
上述针组件应当很小以方便使用，但应制成确保可靠而快速的回流。上面所介绍和图示的针组件中回流的发生按照理想气体定律操作。尤其是，在很低密度下，所有气体和蒸汽都接近理想气体性能，并严格遵循由下式规定的波义耳和查理定律：
P1V1＝P2V2
式中：P1代表在针插入之前针组件内空气的压力；
P2代表在静脉进入之后针组件内空气的压力；
V1代表在静脉进入之前针组件内空气的体积；
V2代表在静脉进入之后针组件内空气的体积。
为方便使用，设计参数应使针装置尽可能小，同时确保如前述方程所规定的合适的体积。为了示出理想气体定律的应用，图5和图6提供了图1的针组件210的示意图。在这方面，A表示穿过入口插管236的内腔248的体积，B代表外壳内部220、回流腔室226、穿过出口插管252的内腔242和可封闭套筒261的总体积。再参见上述方程，P1是使用之前针组件210内的压力，并因此基本等于大气压力。大气压力将随着时间和地点的不同而稍有变动。然而，为了这种分析起见，将大气压力P1假定为760mmHg柱。上述方程中的P2是在静脉进入之后针组件210中死空间的体积。更具体地说，在静脉进入之后，血液将填充入口插管236的内腔248，从而减少了在针组件210的其余部分中气体所占的体积，并因此增加了针组件210的其余部分中空气的压力。近似具有如图1所示尺寸的针组件在静脉压力(带压脉器)下将具有压力P2，约为790mmHg柱。上述方程中V1限定了使用之前针组件210中总的死空间体积，并因此将等于A+B，如图5所示。V2限定了在静脉进入之后装置中的死空间，且入口插管236的内腔248装满血液。因此，上述方程中的V2将等于B。这些输入参数可以用来限定针组件210的相应部件最小所需尺寸，如下列理想气体定律方程的应用中所表明的。
P1V1＝P2V2
P1/P2＝V2/V1
760/790＝B/(A+B)
0.962＝B/(A+B)
0.962(A+B)＝B
0.038B＝0.962A
B＝25.3A
因此，在外壳212、出口插管252和套筒261中的死空间至少是穿过入口插管236的内腔246所限定的体积的25.3倍，而最优选的是约为内腔248体积的26倍。然而，其它构造也是可能的，并且也将起到这里所介绍的作用。
当抽空的管子放成与出口插管252连通时，直接的响应是将血液从静脉抽到管子中(未显示)。在静脉和抽空的管子之间总是保持最高的压力梯度。因此，轴向对准的入口插管236和出口插管252提供了无阻碍的路线，用于血液从静脉流入抽空的管子中。
当血液充满了必需的管子时，将针组件从静脉中抽出。通气孔塞900的密封特性阻止了外壳内部220中的加压空气流入回流腔室226和入口插管236，从而促使血液从IV插管尖端滴落。
上述实施例显示了结构上分离的入口插管和出口插管，所述入口插管和出口插管在轴向上相互对准，并且彼此成紧密的首尾相连的关系放置。然而，上述本发明的原理也可以利用在回流腔室内形成有横向槽或小孔的单个插管实现。例如，图7示意性地显示了一种带有外壳312的针组件310，所述外壳312基本上与上面所描述和示出的外壳212相同。针组件310与针组件210的不同之处在于，提供单个双端针插管336，并完全穿过外壳312。更具体地说，针插管336包括静脉进入端338，非患者端340和在它们之间延伸的内腔342。插管336在内壁324内的部分包括槽或小孔344，以便在内壁324内提供内腔342与回流腔室336之间的连通。针组件310基本上用与上面所描述和图示的针组件210相同的方式起作用。
相对尺寸计算、体积和压力将适用于本发明的举例说明的和未举例说明的实施例。因此，所附权利要求所限定的范围不限于具体举例说明的实施例。在不脱离本发明的范围和主旨的情况下，本领域技术人员可以实施各种其它变化和修改，并且要求将所有这些改变和修改都归入本发明的范围之内。

Claims (14)

1.一种针组件，其包括：
外壳，其包括
(a)外壳内部，
(b)与外壳内部相通的腔室，
(c)安装在外壳中与所述腔室相通的第一插管和安装在外壳中与所述腔室相通的第二插管，或者安装在外壳中并具有与所述腔室相通的开口的单个插管，
其中，所述外壳内部与外部环境之间的唯一连通通路经由所述腔室；
通气机构，其位于所述腔室与所述外壳之间的连通通路上；
其中，与血液接触时，所述通气机构密封，防止空气从外壳内部流到腔室中。
2.权利要求1所述的针组件，还包括：
可密封的套筒，所述套筒安装在所述第二插管的设置在所述外壳外部的部分上；
其中，所述可密封的套筒、所述第二插管的内腔、所述外壳的所述腔室和所述外壳内部限定了组合体积，该组合体积是所述第一插管的内腔所限定体积的26倍。
3.权利要求2所述的针组件，其特征在于，所述第一插管的内腔与所述第二插管的内腔基本上在轴向上对准。
4.权利要求1所述的针组件，其特征在于，所述外壳的外壁和所述腔室的壁由透明或半透明塑料形成。
5.权利要求1所述的针组件，其特征在于，所述外壳的外壁包括透明或半透明的窗口区，并且所述腔室的壁由透明或半透明塑料形成。
6.权利要求1所述的针组件，其特征在于，所述通气机构是由疏水的载体材料形成并且还包括与血液接触时会膨胀的亲水材料的多孔塞或者是单向阀。
7.权利要求6所述的针组件，其特征在于，所述通气机构是多孔塞，并且所述多孔塞还包括一种生物试剂，该试剂通过生物学现象引起上述密封，防止空气流动。
8.权利要求6所述的针组件，其特征在于，所述通气机构是多孔塞，并且所述的疏水载体材料由下列各物组成的组中选出：高密度聚乙烯、聚四氟乙烯、超高分子量聚乙烯、尼龙6、聚丙烯、聚偏二氟乙烯和聚醚砜。
9.权利要求1所述的针组件；
其中，所述第一插管包括入口插管，该入口插管具有相对的外端和内端以及在所述入口插管的外端和内端之间延伸的内腔，所述的入口插管安装在所述外壳上，以使所述入口插管的所述外端在所述外壳的外部，并且使得穿过所述入口插管的所述内腔与所述腔室连通；
其中，所述第二插管包括出口插管，该出口插管具有相对的内端和外端以及在所述出口插管的外端和内端之间延伸的内腔，所述出口插管安装在所述外壳上，以使所述出口插管的所述外端在所述外壳的外部，并且使得所述出口插管的内腔与所述腔室连通。
10.权利要求1所述的针组件，其特征在于，外壳包括所述单个插管。
11.权利要求1所述的针组件，其特征在于，所述通气机构完全位于腔室的内部。
12.权利要求1所述的针组件，其特征在于，所述通气机构部分地位于腔室的内部。
13.权利要求1所述的针组件，其特征在于，所述通气机构位于外壳内部的出口壁的凹槽内，以使通气机构邻接腔室的出口。
14.一种针组件，包括：
外壳，其包括
(a)外壳内部，
(b)与外壳内部相通的腔室，
(c)安装在外壳中与腔室相通的第一插管和安装在外壳中与腔室相通的第二插管，或者安装在外壳中具有与腔室相通的开口的单个插管，
其中，外壳内部与外部环境之间的唯一连通通路经由所述腔室；
通气机构，其位于所述腔室与所述外壳之间的连通通路上；
可密封的套筒，所述套筒安装在所述第二插管的设置在所述外壳的出口端外部的部分上；
其中，所述可密封的套筒、所述第二插管的内腔、所述外壳的所述腔室和所述外壳内部限定了组合体积，该组合体积大于所述第一插管的内腔所限定的体积；
其中，与血液接触时，所述通气机构密封，防止空气从外壳内部流到所述腔室中。
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US20100145226A1 (en) 2010-06-10
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