CN1522666A - 用于穿刺设备的端盖和使用方法 - Google Patents

用于穿刺设备的端盖和使用方法 Download PDF

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CN1522666A
CN1522666A CNA2004100059069A CN200410005906A CN1522666A CN 1522666 A CN1522666 A CN 1522666A CN A2004100059069 A CNA2004100059069 A CN A2004100059069A CN 200410005906 A CN200410005906 A CN 200410005906A CN 1522666 A CN1522666 A CN 1522666A
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end cap
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M・A・海里
M·A·海里
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Bayer Healthcare LLC
Bayer Corp
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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
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15107Piercing being assisted by a triggering mechanism
    • A61B5/15113Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • 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
    • 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
    • A61B5/150053Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061Means for enhancing collection
    • A61B5/150068Means for enhancing collection by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
    • 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
    • A61B5/150206Construction 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

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Abstract

一种用于穿刺设备的端盖,包括带有肋状物或加压点图案的一个接触面,所述接触面用来按摩刺破部位周围的皮肤,从而促进从刺破部位的刺孔中流出用于测试的血液。肋状物图案包括在肋状物之间限定的沟槽,在按摩时,沟槽不会在皮肤上施加压力,从而血液在沟槽下的皮肤下流向刺孔。通过在持续的压力下将接触面应用于皮肤、振动所述接触面、旋转所述接触面或上下移动所述接触面,可以进行按摩。

Description

用于穿刺设备的端盖和使用方法
技术领域
本发明一般涉及血液检测设备,以及更具体地说涉及用于血液检测设备的端盖,该端盖具有带肋状物图案的面,其用于在替换的人体部位上用针刺出刺孔之前或之后按摩皮肤以使血液从刺孔中流出。
背景技术
快速、无痛地获得血样以及对血样进行分析经常是必须的。需要无痛地获得血样的一个实例和血糖检测系统有关,在这种情况下,使用者必须经常使用该系统来检测使用者的血糖水平。
具有不正常的血糖浓度水平的人会被要求定期自我检测他们的血糖浓度水平。不正常的血糖水平可能是由各种各样的原因引起的,包括例如糖尿病这类的疾病。检测血糖浓度水平的目的是确定血糖浓度水平以及然后基于血糖水平是太高还是太低来采取校正措施以使血糖水平回到正常范围。采取校正措施失败可能有严重的后果。当血糖水平下降地太低—低血糖状态—人可能变得神经紧张、颤抖和慌乱。这个人的判断力可能变弱并可能最后昏厥。如果血糖水平变得太高—高血糖状态—人也可能生病。低血糖和高血糖这两种状态都是潜在的威胁生命的紧急情况。
检测人的血糖水平的一种方法是使用轻便的、手提血糖测试设备。为了用测试设备检查血糖水平,需要使用穿刺设备从指尖获得一滴血。典型的穿刺设备包括用于刺破手指皮肤的刺血针。这种检测过程经常一天要重复几次。因为这个过程可能疼痛,所以改进了仪器以使从除了指尖之外的替换部位获得血液,该替换部位例如是胳膊、腿以及手掌。尽管从替换部位获得血样减轻了疼痛,但该过程通常很慢。因此可利用的仪器使用真空或压力来加速从替换部位的刺孔获得血液。这些设备经常在该部位引起血肿。其它设备使用阻塞刺孔处的血液供应的压环。已知这些过程是切断通过非常细的毛细血管的血液流动,这些毛细血管通常在这些替换部位的皮肤下找到。
发明内容
本发明是用于穿刺设备的端盖,该穿刺设备用来刺破皮肤以便抽取测试用的血液。该端盖允许穿刺设备无痛、快速地刺破首要部位例如指尖或替换部位例如手臂。该端盖具有加压点或肋状物图案的面。该图案包括在加压点或肋状物之间的沟槽或缝隙。
在穿刺设备上带有端盖,该端盖的面压到所选部位的皮肤上。通过振动、转动、陷入或按压处于皮肤上的端盖或组合一种以上的技术来用肋状物或加压点图案按摩皮肤,促使血液在沟槽下面流向刺孔处。端盖可以用透明材料铸模形成以允许使用者观察刺孔和抽到皮肤表面的血液量。
附图说明
本发明的其它目的和优点通过结合附图阅读下列详细的说明而变得更清楚,其中:
图1是带有依照本发明第一个实施例构建的端盖的穿刺设备的放大透视图;
图2是本发明第二个实施例的放大透视图;
图3是本发明第三个实施例的放大透视图;
图4是本发明第四个实施例的放大透视图;
图5是本发明第五个实施例的放大透视图;
图6是本发明第六个实施例的放大透视图;
图7是本发明第七个实施例的放大透视图;
图8是本发明第八个实施例的放大透视图;
图9是本发明第九个实施例的放大透视图;
图10是本发明第十个实施例的放大透视图;
图11是本发明第十一个实施例的放大透视图;
图12是沿图1中的线12-12获取的端盖横截面图。
优选实施例的详细描述
许多儿童和成人必须在一天内抽几次血以便对所抽的血样进行分析。使用穿刺设备来抽血。图1显示了带有依照本发明原理构建的端盖12的已知穿刺设备10的一个实例。这种已知穿刺设备10在美国专利5,954,738中进行了描述且该专利在这儿全部引用作为参考。穿刺设备10包括主壳体14和相对主壳体14可活动的活动壳体16。在内部,穿刺设备10包括用于刺破皮肤的针和驱动机构,该驱动机构用于驱动针伸到端盖12的外部并进入患者皮肤。驱动机构通过使活动壳体16从主壳体14上脱离而处于预工作位置。驱动机构通过按动按钮18而启动。依照本发明,穿刺设备10配置有替换部位端盖12。通过端盖12的使用,穿刺设备10可以用来从除了指尖之外的患者身体的其它部位获得血样,如果需要,端盖12也允许从指尖抽取血液。从如胳膊或腿这样的替换部位获得血样减小了患者经历的疼痛。
端盖12包括可释放地固定在穿刺设备10上的基盖20。端盖12也包括具有中心孔24的顶盖22,该中心孔24在穿刺设备10中用做针的通道。顶盖具有向孔24倾斜的凹面(斜面)26(图13)。
顶盖20的面26包括由6个肋状物或加压点28组成的图案。肋状物28具有一定高度以达到象在下文中描述的作用或按摩。已经发现0.030英寸到0.060英寸的高度是有效的。图案包括在相邻肋状物28之间的缝隙或沟槽30。肋状物28也平行于凹面而倾斜。
使用时,穿刺设备10用顶盖22的面26对着例如胳膊或腿的替换部位的皮肤放置。肋状物28的图案在刺孔部位周围的皮肤上提供加压点,同时肋状物28之间的缝隙或沟槽30在皮肤上限定了没有压力的区域。这些没有压力的区域充当了在皮肤下面供血液流向刺孔的沟槽,该刺孔是穿刺设备10的针在皮肤上形成的。
当针刺入皮肤且刺孔形成后,穿刺设备10用顶盖22的面26对着皮肤而保持在患者的皮肤上。接着用四种技术中的一种或组合一种以上的技术来按摩皮肤以引起血液流向该血液被取得和被测试的刺孔。这些按摩技术也可以在刺破皮肤前应用以便为更好的血液流动做准备。一种按摩技术是将柔和的压力施加到皮肤上,同时顺时针和逆时针交替地旋转端盖12。第二种按摩技术是振动顶盖22。第三种按摩技术是通过顶盖22的上下运动来重复地施加和释放刺孔部位的压力。第四种按摩技术是在压下顶盖22刺破皮肤后在刺孔部位施加5到20秒的持续压力。在所有这些技术中,端盖12必须严格地保持在一个位置。这些按摩技术的每一种引起血液流向刺孔,并可以在穿刺前、穿刺后或穿刺前后进行。这些按摩技术可以独立或组合进行。在按摩时肋状物28也用于抓紧患者的皮肤以使穿刺设备10更容易地保持在刺孔部位上,这样减小了弄脏血样的机会。
面22的凹面构型进一步有助于血液的流动(图12)。面22从外边缘到中心孔24有5到6度的角。尽管面22可以是平的,但凹面构型有助于促进血液流向中心孔24。优选肋状物或加压点28平行于凹面并沿凹面延伸。
当按摩刺孔部位时,使用者应当观察刺孔部位来确定面26和皮肤的接触以及决定已获得充足血样的时间。为了能够进行这些观察,基盖20和顶盖22可以用透明材料形成。一旦刺孔处有充足的血样,就可以从该部位移去穿刺设备10,接着将测试仪器应用于血样。
各种肋状物图案在图2-11中显示并将对这些图案进行简要地描述。在图2-11的每一幅图中的端盖、基盖和顶盖都和图1中的端盖12、基盖20和顶盖22相同。所以,这些相同的附图标记出现在图2-11中用来表示端盖、基盖和顶盖。
图2的肋状物图案包括和中心孔24同心的二条半圆形肋状物328。在半圆形肋状物328的相邻末端之间限定了缝隙或沟槽330。
图3中显示的图案是三条放射状肋状物428以及在相邻肋状物428的末端之间限定的三条缝隙或沟槽430。肋状物428和中心孔24同心。图4中的肋状物图案和图3的图案相似但有四条和中心孔24同心的放射状肋状物528以及限定的缝隙或沟槽530。相似地在图5中显示了都和中心孔24同心的六条放射状肋状物628的图案和六个缝隙或沟槽630。
图6中的端盖12和图1-5中的端盖12不同,在图6中是六个球形肋状物728的图案以及在球形肋状物728之间限定的缝隙或沟槽730。
除了图7中的图案包括四条放射状肋状物828以及四条缝隙或沟槽830之外,图7中的图案和图1中的图案相似。
图8是图1从穿刺设备10上分离的端盖12的独立显示等大示意图。除了图9中四条肋状物1028为S形以及在相邻肋状物1028之间限定了缝隙或沟槽1030外,图9的端盖12和图7的端盖相似。相似地,图10的图案包括六条S形肋状物1128和六条沟槽1130。
图11显示了肋状物图案的另一种方式。这个图案包括六条T形肋状物1128和六条沟槽1230。
虽然本发明容许各种修改和替换形式,但其具体的实施例还是通过附图中的实例示出并在此进行了详细描述。然而应当理解,这并不是为了把本发明限制在所公开的特殊实例里,而相反,是为了覆盖落入由所附的权利要求限定的本发明的精神和范围内的所有修改、等同物和替换例。

Claims (19)

1、一种用于穿刺设备的端盖,该端盖包括:
一个主体;
在所述主体上的一个接触面;
在所述接触面内的一个开口;以及
在所述面上的加压点图案,其中:
所述加压点包括若干肋状物组成的图案和在相邻肋状物之间限定的沟槽。
2、如权利要求1所述的端盖,其中:所述主体由透明材料形成。
3、如权利要求1所述的端盖,其中:所述接触面是凹面。
4、如权利要求1所述的端盖,其中:所述加压点和所述开口同心。
5、如权利要求1所述的端盖,其中:所述加压点从所述开口呈放射状延伸。
6、一种用于穿刺设备的端盖,该端盖包括:
一个主体,所述主体包括一个面、在所述面内用作针通道的一个孔,所述面是凹面,以及在所述面上的肋状物图案。
7、如权利要求6所述的端盖,其中:所述肋状物图案包括若干肋状物,在所述肋状物之间限定了沟槽。
8、如权利要求6所述的端盖,其中:所述主体由透明材料形成。
9、如权利要求6所述的端盖,其中:所述肋状物图案包括和所述孔同心的若干肋状物。
10、如权利要求6所述的端盖,其中:所述肋状物图案包括从所述孔呈放射状延伸的若干肋状物。
11、一种抽取用于测试的血样的方法,该方法包括:
提供具有针和端盖的穿刺设备,所述端盖包括一个皮肤接触面,在所述面上有加压点图案;
把所述端盖的所述面放置在选定部位上;
驱动所述针刺破所述选择部位的皮肤;以及,
用所述皮肤接触面在所述部位上按摩所述部位以使血液流到所述刺孔。
12、如权利要求11所述的抽取用于测试的血样的方法,该方法进一步包括:在驱动所述针之前用所述皮肤接触面按摩所述部位。
13、如权利要求11所述的抽取用于测试的血样的方法,其中:按摩所述部位包括在所述选定部位保持压力的同时,按顺时针和逆时针交替地转动所述端盖。
14、如权利要求11所述的抽取用于测试的血样的方法,其中:按摩所述部位包括在所述部位上振动所述皮肤接触面。
15、如权利要求11所述的抽取用于测试的血样的方法,其中:按摩所述部位包括移动所述皮肤接触面靠近和离开所述部位。
16、如权利要求11所述的抽取用于测试的血样的方法,其中:按摩所述部位包括将持续的压力施加到所述皮肤接触面上以使所述皮肤接触面向所述部位移动以及在上面施加持续的压力。
17、如权利要求11所述的抽取用于测试的血样的方法,该方法进一步包括:形成所述加压点图案以在所述加压点之间的皮肤接触面上限定沟槽。
18、如权利要求11所述的抽取用于测试的血样的方法,其中:所述皮肤接触面包括用作所述针的通道的一个孔,进一步包括在所述孔的周围使所述皮肤接触面倾斜,从而当所述皮肤接触面按摩所述部位时,向着所述孔的方向压力逐渐减小。
19、如权利要求11所述的抽取用于测试的血样的方法,其中:所述端盖是透明的,进一步包括当按摩所述部位时,通过所述透明端盖观察所述选定部位来确定用于测试的血液量。
CNB2004100059069A 2003-02-19 2004-02-18 用于穿刺设备的端盖 Expired - Fee Related CN100409808C (zh)

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AU2004200523A1 (en) 2004-09-09
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CN100409808C (zh) 2008-08-13

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