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CN110269629B - 单针式采血管保持器 - Google Patents

单针式采血管保持器 Download PDF

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Publication number
CN110269629B
CN110269629B CN201910105586.0A CN201910105586A CN110269629B CN 110269629 B CN110269629 B CN 110269629B CN 201910105586 A CN201910105586 A CN 201910105586A CN 110269629 B CN110269629 B CN 110269629B
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needle
tube holder
blood collection
barrel
collection tube
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CN110269629A (zh
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托马斯·J·肖
马克·斯摩尔
朱霓
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Retractable Technologies Inc
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Retractable Technologies Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150259Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150351Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
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    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150389Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150412Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A61B5/150427Specific tip design, e.g. for improved penetration characteristics
    • AHUMAN NECESSITIES
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    • A61B5/150473Double-ended needles, e.g. used with pre-evacuated sampling tubes
    • AHUMAN NECESSITIES
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    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150633Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
    • A61B5/150641Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position
    • A61B5/150656Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position semi-automatically triggered, i.e. in which the triggering of the protective sleeve requires a deliberate action by the user, e.g. manual release of spring-biased extension means
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150732Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150885Preventing re-use
    • A61B5/150908Preventing re-use by disconnecting components, e.g. breaking or rupturing of connected parts, e.g. piston and rod
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    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
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    • A61B5/14Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405Devices for taking blood samples
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150572Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694Procedure for removing protection means at the time of piercing
    • A61B5/150717Procedure for removing protection means at the time of piercing manually removed
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    • A61B5/15Devices for taking samples of blood
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    • A61B5/150801Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
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    • A61B5/155Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals

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Abstract

一种采血管保持器,其具有可缩回单针和主体,所述主体包括基本平行且横向间隔开的筒和针缩回腔,筒和针缩回腔由部分壁分开,其便于单针从筒腔横向移动到与针缩回腔对准,以启动针缩回。筒和与筒的前部附件配合地配置以便于在横向于穿过可缩回单针的纵向轴线的方向上的相对滑动移动,以启动针缩回。

Description

单针式采血管保持器
技术领域
本发明是一种用于从人或动物抽血的医疗装置。本装置通常被称为“采血管保持器”或“血液管保持器”,因为它被配置成与由几个不同的公司制造和销售的常规市售“采血管”或“血液管”结合使用。本发明还涉及一种具有单针的单次使用的采血管保持器,所述单针在使用后可缩回到装置内的密闭空间中,以保护患者和医护人员免受意外针刺,从而减少由此引起的病原性污染的相关可能性。本发明的一个方面涉及一种采血管保持器,其具有主体,该主体包括基本上平行且横向间隔开的筒和针缩回腔,筒和针缩回腔由部分壁分开,其便于可缩回单针从所述筒腔横向移动成与所述针缩回腔对准,以启动针缩回。本发明的另一方面涉及一种采血管保持器,其具有筒和前部附件,所述筒和前部附件配合地配置成便于它们之间沿横向于穿过针的纵向轴线的方向的相对滑动移动。
背景技术
传统的采血管保持器例如在美国专利号5,810,775、RE39,107、8,496,600、9,247,899和美国公开号20160310057、20180008180和2018/0008181中公开。
一些这样的装置具有两个单独的针,包括向前指向的穿刺针和向后指向的排放针。当管插入筒的开口后端时,排放针穿过设置在采血管前部的塞子。在采集流体样品之后,将采血管从血液管保持器的筒中移除,并且聚合物护套膨胀以覆盖面向后的针尖,以防止体液从筒的开口后部漏出。在一个这样的装置中,在筒的后部设置铰接帽,并且在移除采血管之后关闭帽,触发排放针和穿刺针向后缩回到筒中,从而使装置呈现“安全”且不可重复使用。
最近,已经公开了采血管保持器,其包括较长的向后偏置的单针,其具有面向前和向后的尖端。在采集流体样本并移除采血管之后,通过按下包含针缩回腔的致动器来启动针缩回,所述缩回腔移动到与针充分对准的位置,针的两端向后偏置进入装置的针缩回腔,从而使装置呈现“安全”且不可重复使用。
最近,已经公开了采血管保持器,其包括单独的穿刺和排放针,以及用于穿刺针的缩回腔,其设置在筒的旁边并与其平行,或者作为与筒一体制成的单独腔室,或作为筒的前部附件的一部分。穿刺针向后偏置,并且穿刺针的缩回通过至少部分筒的前部附件的横向滑动移动而启动。在这种移动过程中,向前突出的穿刺针横向移动而不与朝后的排放针对齐,以与针缩回腔基本同轴对齐。一旦穿刺针与针缩回腔基本对齐,向后指向的偏置力使穿刺针撤回到装置内的“安全”位置,同时排放针保持设置在筒内的原始位置。在针缩回之前或之后,采血管可以从筒中取出,并且弹性护套在排放针的面向后的尖端上方膨胀,以防止体液从筒的开口后端漏出。
尽管通过使用先前公开的装置实现了改进和优点,但是需要一种包括单针的采血管保持器,该单针可以在使用之后通过前部附件相对于筒的横向滑动移动而缩回以重新定位整个针与一个与筒整体制成的全长针缩回腔大致同轴对齐。
发明内容
本发明公开了一种采血管保持器,其包括基本上柱形的主体、前部附件和可缩回单针,所述可缩回单针包括相反定向的穿刺端或尖端和流体排放端或尖端。主体和前部附件配合地配置成在针缩回之前便于主体相对于单针的滑动横向移动。在本发明的一个令人满意的实施例中,主体还包括基本上柱形的筒腔和整体形成的针缩回腔,它们基本上平行并由部分壁分开。部分壁理想地配置成便于单针的流体排放端从第一位置到第二位置的滑动横向移动,在第一位置中,可缩回单针基本上居中位于筒腔内并与筒腔同轴地对准,在第二位置中,可缩回单针基本上并与针缩回腔对准。筒腔配置成接收和支撑传统的采血管,其与单针的流体排放端可操作地接合。
单针的穿刺端从前部附件向前突出,并且在使用之前理想地由可选择性释放的针帽覆盖。前部附件还包括管保持器连接器和滑动构件,所述管保持器连接器摩擦地接合并部分地覆盖所述筒的开口前端,所述滑动构件沿着轴线可滑动地接合所述管保持器连接器,所述轴线基本上横向于穿过所述单针的纵向轴线。滑动构件配置成安置并支撑向后偏压的针保持器,该针保持器以与单针固定的关系附接。管保持器连接器还包括横向槽,当相反方向的手动压力施加到主体和滑动构件上时,该横向槽便于单针在第一位置和第二位置之间的相对地横向移动,以便基本上对准针保持器和针缩回腔以启动将单针缩回到针缩回腔中。在本发明的一个优选实施例中,可选择性释放的针帽还包括锁定臂,该锁定臂防止滑动构件和针缩回腔变得基本对准,从而在使用之前启动单针的缩回。
附图说明
结合以下附图进一步描述和解释本发明的设备,其中:
图1是本发明的采血管保持器的一个实施例的前透视图;
图2是图1的采血管保持器的前透视图,其中针帽被移除;
图3是图1的采血管保持器的后透视图;
图4是基本上如图1和图3所示的采血管支架的俯视图,不同之处在于图4中的标记还示出虚线轮廓;
图5是图1的采血管保持器的前视图,但是绕其纵向轴线顺时针旋转90度;
图6是图5的采血管保持器的后视图;
图7是图4的采血管保持器的俯视图,其中针帽已被移除;
图8是图1和图3的采血管保持器的右侧视图;
图9是图1的采血管保持器的左侧视图,绕其纵向轴线顺时针旋转180度。
图10是沿图5的A-A线的剖视图。
图11是图1的采血管保持器的分解透视图;
图12是图7的采血管保持器,其中穿刺针缩回;
图13是图5的采血管保持器,其中针盖被移除并且穿刺针缩回;
图14是沿图13的C-C线的剖视图;
图15是图2的采血管保持器,其中针缩回;
图16是图11的针支撑构件的放大细节图;
图17是图16的针支撑构件的后透视图,沿穿过主体采血管保持器的纵向轴线绕顺时针方向旋转180度;
图18是图11的管保持器连接器的放大细节图;
图19是图18的管保持器连接器的后透视图,沿穿过主体采血管保持器的纵向轴线绕顺时针方向旋转180度;以及
图20是沿图4的B-B线的放大剖视图。
具体实施方式
参见图1至图11,采血管保持器10包括:主体12;前部附件,还包括管保持器连接器24和滑动构件38;针帽40(图1和图3);以及可缩回单针30(图2)。主体12还包括筒16、筒腔14、针缩回室20和围绕筒16的后开口设置的后凸缘22。参见图2和图7,可缩回单针30从前部附件的滑动构件38的针支撑构件46向前突出。
参考图4至图6和图8至图10,采血管保持器10被描绘在其使用前位置,其中可选择性移除的针帽40安装在可缩回单针30上并且摩擦地接合轴向延伸的周向间隔肋,其设置在针支撑构件46周围(图7中可见)。提供锁定支撑臂42(图10-图11中可见)以防止在使用可缩回单针30从患者抽血之前在主体12和滑动构件38之间的相对滑动移动。滑动构件38还包括前表面44,针支撑构件46从围绕可缩回单针30的一部分向前突出,如图7中最佳所示。
参照图10-图11,可缩回单针30还包括面向前的穿刺端32和面向后的流体排放端34。在将采血管(未示出)插入到筒腔14中和使用采血管保持器10从患者采集血液之前,可选择性释放的针帽40在如上文所述的位置,并且可折叠弹性护套26覆盖可缩回单针30的流体排放端34,以防止流体排放端34受到无意的污染。当采血管插入主体12的筒16的筒腔14中时,护套26围绕可缩回单针30向后折叠,允许流体排放端34穿透采血管中的弹性塞子,以在可缩回单针30的穿刺端32和采血管的内部(抽出的血液被排放到其中)之间建立流体连通。当单个可缩回针30处于其如图10所示的使用前位置时,针30基本上居中位于筒腔14内,并且与主体12的针缩回室20内的针缩回腔76横向间隔开。
再次参见图10-图11,可缩回单针30理想地以与针保持器28、92固定的轴向关系附接,其还包括向后延伸的环形凸起94,用于与可折叠弹性护套26(优选是橡胶套)的向前延伸端摩擦接合。诸如可压缩螺旋弹簧36的偏置构件理想地安置在针支撑构件46的孔60(图16)内,围绕针30的中心设置部分和针保持器26的面向前的轴部分,并且当在采血管保持器10的组装期间被压缩时,抵靠并接合针保持器28的头部92的前侧。只要可缩回单针30保持在其向前突出位置,针保持器28的头部92相对于采血管保持器10的前部附件和主体12向后偏置。
参见图11、图16-图17和图20,主体12的前部附件的滑动构件38(图7)还包括相对的定位块54、56,其可与针保持器28的配合地配置的头部92接合(图11)以如下所述横向移动针保持器28。横向延伸的顶部和底部导轨50、52分别配合地配置并且可与管保持器连接器24的横向延伸的顶部和底部导轨68、70可滑动地接合。参见图17-图18,滑动构件38上的突起96、98(图17)理想地设置成接合管保持器连接器24的配合地配置和对准的凹槽100(底部凹槽不可见),以在组装和使用采血管保持器10期间将可缩回单针30适当地定位在管保持器连接器24的槽72内。参见图11、图18-图19,提供管保持器连接器24的周向延伸的弧形环64和配合圆形壁62,以在管保持器连接器24和主体12的筒16的面向前的边缘之间建立摩擦接合。理想地,摩擦接合足以使管保持器连接器24保持附接到筒16的前端,因为相反方向的压力施加到纹理化触摸表面74、48,如下所述。
图5-图6和图13进一步描绘了相关于凸缘22的相对的弧形边缘88、90的相对的平坦边缘84、86以及当针30分别处于未缩回和缩回位置时滑动构件38和管保持器连接器24的相对位置。
参见图5和图7-图11,滑动构件38和主体12的前部附件的管保持器连接器24分别设有纹理触摸板48、74,以便于向每个触摸板施加相反方向的手动压力,以产生主体12相对于滑动构件34、针保持器28、压缩弹簧36和可缩回单针30的横向滑动移动。该移动理想地在横向方向上使得可缩回单针30的排放针端34横向移动经过部分壁82的减小高度部分80(图10),直到针30与针缩回腔76基本对齐,这允许针保持器28和排放针端部34随着压缩螺旋弹簧36膨胀到图14所示的位置而向后移动到针缩回腔76中。可缩回单针30的长度理想地使得当处于如图14所示的位置时,针30的穿刺端32完全包含在滑动构件38的针支撑构件46内。图12-图15描绘了本发明的采血管保持器10,其中可缩回单针30处于完全缩回位置。
在根据附图阅读本说明书后,本发明的其他改变和修改对于本领域普通技术人员来说同样变得显而易见,并且本文所公开的本发明的范围仅由对本发明人/申请人在法律上被授予权利的所附权利要求书的最广泛的解释所确定。

Claims (8)

1.一种采血管保持器,包括:
基本上柱形的主体,包括筒和整体形成的针缩回腔;
前部附件,包括:管保持器连接器,联接至所述筒;和滑动构件,滑动地接合所述管保持器连接器;以及
可缩回单针,包括相反定向的穿刺端和流体排放端,其中,所述穿刺端从所述滑动构件向前延伸,并且其中,所述流体排放端在所述筒中向后延伸;
其中,所述筒包括筒腔,并且其中,所述筒腔和所述针缩回腔布置成固定的、基本平行的关系并且由部分壁分开;并且
其中,所述部分壁包括减小高度部分,所述减小高度部分配置为允许所述可缩回单针的所述流体排放端经过所述部分壁的所述减小高度部分从第一位置向第二位置的横向滑动移动,以启动所述可缩回单针缩回到所述针缩回腔中,在所述第一位置中,所述可缩回单针与所述筒腔同轴地对准,在所述第二位置中,所述可缩回单针与所述针缩回腔同轴地对准。
2.根据权利要求1所述的采血管保持器,其中,所述可缩回单针的所述穿刺端从所述滑动构件向前突出,在所述可缩回单针缩回到所述针缩回腔中之前,所述滑动构件滑动地接合所述管保持器连接器。
3.根据权利要求1所述的采血管保持器,其中,所述可缩回单针的所述穿刺端在使用前被可选择性释放的针帽覆盖。
4.根据权利要求1所述的采血管保持器,其中,所述管保持器连接器摩擦地接合所述筒的敞开的前端。
5.根据权利要求4所述的采血管保持器,其中,所述滑动构件沿着轴线能滑动地接合所述管保持器连接器,所述轴线基本上横向于穿过所述可缩回单针的纵向轴线。
6.根据权利要求1所述的采血管保持器,其中,所述滑动构件包括针支撑构件,所述针支撑构件接收弹簧,以向后偏压针保持器,所述针保持器以与所述可缩回单针固定的关系附接。
7.根据权利要求5所述的采血管保持器,其中,所述管保持器连接器还包括横向槽,当相反方向的手动压力施加到所述管保持器连接器和所述滑动构件时,所述横向槽便于所述可缩回单针的相对地横向移动。
8.根据权利要求3所述的采血管保持器,其中,所述可选择性释放的针帽还包括锁定臂,所述锁定臂防止所述滑动构件和所述针缩回腔过早地基本上对准,从而在使用所述采血管保持器用于抽血之前启动针缩回。
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