CN1180748C - 可减轻痛苦的刺血装置 - Google Patents

可减轻痛苦的刺血装置 Download PDF

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CN1180748C
CN1180748C CNB001022970A CN00102297A CN1180748C CN 1180748 C CN1180748 C CN 1180748C CN B001022970 A CNB001022970 A CN B001022970A CN 00102297 A CN00102297 A CN 00102297A CN 1180748 C CN1180748 C CN 1180748C
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clamper
spring
shell
lancet
order
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W��C��̩��
W·C·泰勒
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R·W·勒沃恩
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J·M·普尔勒
3
C·J·鲁夫
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LifeScan Inc
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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
    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of 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
    • A61B5/150175—Adjustment of penetration depth
    • A61B5/150198—Depth adjustment mechanism at the proximal end of the carrier of the piercing element
    • 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
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • 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
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets 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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism
    • A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • 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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • 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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188—Constructional features of reusable driving devices
    • A61B5/1519—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
    • 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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188—Constructional features of reusable driving devices
    • A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
    • A61B5/15194—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's 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
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150259—Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape

Abstract

一种刺血装置，具有装有第一弹簧的刺血针夹持器，夹持器可滑动地连接在一个外壳内，用以携带一个一次性的刺血针和针头。装置背部上的旋钮具有前伸指状物，它可以在装置被击发后将刺血针夹持器阻挡在一个可调的预定点上。指状物不仅可控制针的刺穿深度，而且可减震和减少噪音以减少使用者的痛苦。所述刺血针装置还包括：一个第二弹簧用以将夹持器推回，弹簧具有一个压在夹持器上的第一端和一个压在滑动器上的第二端；一个位于后端的封罩，包括(i)若干向前伸展的元件用以将夹持器向前的移动阻挡在一个预定的位置上，和(ii)调节装置用以可控制地改变和重新设置该预定的位置；一用来使所述若干向前伸展的元件挠曲的夹持器凸缘。

Description

可减轻痛苦的刺血装置
技术领域
本发明涉及一种刺血装置，用以刺穿皮肤获取血样；特别是，一种可减轻患者痛苦的刺血装置。
背景技术
对于成百万每天必须进行五次或更多次地量测其血液葡萄糖含量的糖尿病患者来说，刺血装置是其生活中的一件令人遗憾的事情。他们通常使用这种装置由手指抽取一滴血，将血液涂在一个一次性的带条上，并在一个测定仪中量测血液中葡萄糖的浓度。这种刺血装置的明显的目的在于使患者以最少的痛苦，麻烦，和费用提供适宜的血液样品。
1985年3月12日授予Cornell等人的美国专利第4,503,856号公开了一种刺血针装置，该装置具有一个管状外壳，一个位于外壳中可滑动的刺血针夹持器和一个可压缩的弹簧以提供将夹持器直线地推动到皮肤的刺穿位置上的力量，随后夹持器即回到其空挡位置上。
1985年7月9日授予Burns的美国专利第4,527,561号公开了一种刺血针装置，该装置包括有第二个弹簧以便在刺血针穿透使用者皮肤之后收回刺血针夹持器(还可参见美国专利第4,535,769和4,553,541号)。
1990年1月23日授予Bodicky等人的美国专利第4,895,147号公开了一种刺血针装置，该装置包括一个刺穿深度选择器和一个在皮肤被刺穿以后形成真空的机构以帮助由刺穿的部位抽取血液。
1990年12月11日授予Neito等人的美国专利第4,976,724号公开了一种刺血针装置，该装置包括一种机构可让使用者射出所使用的刺血针而不和它接触。
1994年6月7日授予Lange等人的美国专利第5,318,584号公开了一种刺血针装置，该装置包括一种旋转/滑动传输系统可以在可调的/可重复的刺穿深度和较少痛苦的情况下实行穿刺。
发明内容
本发明提供了一种用以抽取血液样品的刺血针装置，该装置包括通常为细长的外壳，外壳具有一个在其前端带有贯穿孔的帽盖，该装置还包括
(a)一个刺血针夹持器，可滑动地连接在外壳内，
(b)一个第一弹簧用以向前推动夹持器，弹簧具有一个压在外壳上的第一端和压在夹持器上的第二端，
(c)一个滑动器，可滑动地连接在外壳的壁内，包括
(i)在壁外的一个凸出部分，和
(ii)一个推动装置，可逆地与夹持器相连接，从而将夹持器推回到准备击发状态的位置并将刺血针由装置推向前方，
(d)一个按钮，可以在其第一位置和第二位置之间移动，在第一位置在装置处于准备击发的状态的情况下夹持器受到约束，在第二位置时约束被移开，允许第一弹簧将夹持器向前推进，其特征在于所述刺血针装置还包括：
(e)一个第二弹簧用以将夹持器推回，弹簧具有一个压在夹持器上的第一端和一个压在滑动器上的第二端，
(f)一个位于后端的封罩，包括
(i)若干向前伸展的元件用以将夹持器向前的移动阻挡在一个预定的位置上，和
(ii)调节装置用以可控制地改变和重新设置该预定的位置，
(g)一用来使所述若干向前伸展的元件挠曲的夹持器凸缘。
本发明的装置在刺血操作时仅产生较少的痛苦，因为和已有技术的刺血装置相比减少了针的振动和噪音。另外，由装置的远端控制刺穿的深度提供了较由装置的前方控制有利的优点。这使得本发明的装置带有一个廉价的前端帽盖成为可能，而这又是必须的因为帽盖被污染需要进行更换。另外，由装置的远端控制刺穿的深度很少可能因握持装置的手指而看不清设置的深度。
附图简介
图1为本发明的装置的透视图，其中移去了一半外壳。
图1A为图1所示装置后端的放大的视图。
图2为图1所示装置在其休止位置时的横剖面图。
图3为图1所示装置正处于准备击发状态时的横剖面图。
图4为图1所示装置在过待击发位置时的横剖面图。
图5为图1所示装置在待击发时的横剖面图。
图6为图1所示装置在其击发时的横剖面图。
具体实施方式
本发明提供了一种刺血装置，该装置配有降低噪音和振动的机构用以在刺血操作时减轻痛苦。图1描述了本发明的刺血装置10，其中外壳的一侧被移去以便看清其内部。装置的前端有一个带有贯穿孔14的帽盖12。帽盖12可拆卸地连接在外壳16上，例如，利用螺纹，为了方便外壳由两部分构成。图中示出了一半16A，而另一半已被移去。在装置与帽盖12相对的后端，外壳16与旋钮18相连。旋钮18具有可提供止动的悬臂的指状物18A，其位置可利用螺纹予以改变，例如将旋钮连接到外壳上的螺旋螺纹。
一个刺血针夹持器20在装置的整个操作过程中夹持并引导一次性的刺血针。一个驱动弹簧22贮存着将刺血针驱向前方所需的能量。驱动弹簧22放置在夹持器20内并压在外壳的支柱23上。第二个，“拉回”弹簧24也放置在夹持器20内，该弹簧提供了在皮肤被穿刺以后由皮肤上移去刺血针的机构。拉回弹簧24的弹簧系数基本上小于驱动弹簧22的弹簧系数；因此，驱动弹簧22基本上是比较“有力的”。滑动器26可滑动地连接在外壳16上并在外壳的外部具有一个可用手移动的凸出物26A-向后使装置处于待击发状态，向前可射出刺血针。装置处于待击发状态时，滑动器26和夹持器20相啮合。按钮30穿过外壳与在外壳内突出的翼片30A相连。在装置处于击发状态之后，按下按钮30松开刺血针夹持器20的约束使弹簧22得以将夹持器推向前方。将元件30称为“按钮”并不认为图示的启动器元件是仅有的一种设想。在这里，“按钮”应理解为广泛地适用于此项技术中所周知的可以松开刺血针夹持器上的约束的任何启动器。
图1A表示刺血装置10远端的一个放大的图形。在一个优选实施例所描述的机械止动部件中，由旋钮18向外伸出的悬臂指状物18A具有下部切开的前端形成向内伸出的隆起。当夹持器20向前移动时，如左侧箭头所示的方向，夹持器的凸缘20A最终将接触到悬臂指状物18A上的隆起。夹持器凸缘20A的作用力使指状物挠曲从而缓冲或吸收冲击引起的振动并减少噪音。此二者的效果将减少使用者遭受的痛苦。与装置前端相应的隆起的位置决定了刺血针刺入皮肤的深度。该位置，也可通过旋转位于螺旋18B上的旋钮18进行调整。旋钮上的指示器18C连同外壳上的标记线(未示出)使得装置可以设置给定的可变和可重复的穿刺深度。不同的穿刺深度是需要的，这是因为使用者通常希望为特定的试验提供刚好够用的血液和使用者手指的特点是不同的。设置约7个相同等级深度范围约为1.8mm可以满足几乎所有可能的使用者的需要。
可以从一系列附图中了解到刺血装置的操作，这些附图示出了操作装置的整个过程中装置的各个部件的相对位置。
图2表示装置在休止位置时的横剖面，其中滑动器26的内里部分26B靠在可脱开的连接器28的顶端28A上。驱动弹簧22和拉回弹簧24相平衡地彼此相压。两个弹簧都受压，驱动弹簧22比反回弹簧24要更小些，因其弹簧系数要更大些。在帽盖12里可以看到采用针40和针头42。
图3表示装置在滑动器26向后移(在图3中向右)处于待击发状态时在一个中间位置的横剖面。由滑动器26的推动元件26C的返回移动产生的作用力使拉回弹簧24受到较图2中所示的更大的压力。由于其较大的弹簧系数，驱动弹簧22保持相对地未再受压。
图4说明位于其“过待击发”位置时的刺血装置；即，滑动器26移动到其行程最远端的位置。刺血针夹持器20的悬臂伸出部分44移到略微超出外壳止动装置46(在其右侧)的地方。驱动弹簧22被压缩而拉回弹簧24保持大约与图3所示相同程度的压力。
图5描述位于待击发和休止状态的刺血装置。驱动弹簧22迫使刺血针夹持器20的伸出部分44靠在外壳止动装置46上。滑动器26回到其初始位置(图2)。拉回弹簧24较图3和4略微被压缩。如果现在按下按钮30，翼片30A将伸出部分44推到不受止动装置46约束的地方(推到其下方)并使刺血针夹持器20随着压缩的驱动弹簧22生成的作用力而冲向前方(向左)。
该阶段导致图6所示的瞬时的状态，其中刺血针40达到其最左侧的位置，使针头42伸出帽盖开口14。刺血针夹持器20在其向前(向左)的运动中被悬臂指状物18A上的隆起所阻挡，该指状物为旋钮18内里的元件。如前所述，悬臂指状物略微挠曲，从而吸收一些振动和降低噪音减轻了使用者的痛苦。在一个所示的优选实施例中，利用将指状物18A上的隆起和凸缘20A切割成相匹配的角度从而使其在一个大面积上相接触，使这些效果得到增强。滑动器26仍位于其初始的位置上。驱动弹簧22和夹持器20一起被推向前方并不再受压。拉回弹簧24被压缩，从而对夹持器20施加一个向后(向右)的作用力，结果使刺血针40和针头42被拉回，各部件的位置恢复到图2所示的状态。
熟悉此项技术的人应该理解，前面的描述和附图是对实施本发明的说明，绝不是限制。在不脱离本发明的范围和精神的情况下可以作出这里所述细节的各种变形。

Claims (3)

1.一种用以抽取血液样品的刺血针装置，该装置包括细长的外壳，外壳具有一个在其前端带有贯穿孔的帽盖，该装置还包括
(a)一个刺血针夹持器，可滑动地连接在外壳内，
(b)一个第一弹簧用以向前推动夹持器，弹簧具有一个压在外壳上的第一端和压在夹持器上的第二端，
(c)一个滑动器，可滑动地连接在外壳的壁内，包括
(i)在壁外的一个凸出部分，和
(ii)一个推动装置，可逆地与夹持器相连接，从而将夹持器推回到准备击发状态的位置并将刺血针由装置推向前方，
(d)一个按钮，可以在其第一位置和第二位置之间移动，在第一位置在装置处于准备击发的状态的情况下夹持器受到约束，在第二位置时约束被移开，允许第一弹簧将夹持器向前推进，其特征在于所述刺血针装置还包括：
(e)一个第二弹簧用以将夹持器推回，弹簧具有一个压在夹持器上的第一端和一个压在滑动器上的第二端，
(f)一个位于后端的封罩，包括
(i)若干向前伸展的元件用以将夹持器向前的移动阻挡在一个预定的位置上，和
(ii)调节装置用以可控制地改变和重新设置该预定的位置，
(g)一用来使所述若干向前伸展的元件挠曲的夹持器凸缘。
2.根据权利要求1中所说的装置，其中前伸元件包括悬臂指状物，指状物带有用以和夹持器的一个表面相啮合的向内延伸的隆起。
3.根据权利要求1中所说的装置，其中调节装置带有螺纹用以将封罩连接在外壳上，从而在外壳上旋转封罩可将前伸元件向前和向后放置。
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DE60005421T2 (de) 2004-07-01
CN1264571A (zh) 2000-08-30
EP1031318B1 (en) 2003-09-24
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US6045567A (en) 2000-04-04
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CA2296778A1 (en) 2000-08-23
DE60005421D1 (de) 2003-10-30
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ATE250387T1 (de) 2003-10-15
KR100684479B1 (ko) 2007-02-22
EP1031318A1 (en) 2000-08-30

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