CN1220132A - 体液采样装置 - Google Patents

体液采样装置 Download PDF

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CN1220132A
CN1220132A CN98122671A CN98122671A CN1220132A CN 1220132 A CN1220132 A CN 1220132A CN 98122671 A CN98122671 A CN 98122671A CN 98122671 A CN98122671 A CN 98122671A CN 1220132 A CN1220132 A CN 1220132A
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sleeve
ring
sampling apparatus
respect
skin
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布伦特·G·迪雄
杰弗里·N·罗
理夏德·拉德万斯基
乔尔·S·道格拉斯
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Mercury Diagnostics 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
    • A61B5/15—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
    • A61B5/150015—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
    • A61B5/150053—Details 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
    • A61B5/150061—Means for enhancing collection
    • A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/150541—Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
    • A61B5/150549—Protectors removed by rotational movement, e.g. torsion or screwing
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    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/15058—Joining techniques used for protective means
    • A61B5/150618—Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694—Procedure for removing protection means at the time of piercing
    • A61B5/150717—Procedure for removing protection means at the time of piercing manually removed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism
    • A61B5/15111—Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150633—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves

Abstract

把环放在皮肤上,并重复地对环作用弹性压力,可从皮肤切口采集体液,由此,环的刺激器表面挤压切口周围的一圈皮肤和身体组织,使体液从切口压出。刺激器表面的倾斜角为10到65度;刺激器表面的宽度从5mm到20mm,刺激器表面的内径不小于6.0mm。

Description

体液采样装置
本发明涉及了从人体获得血液和其它液体采样、供分析或处理用的穿刺装置和方法。
在目前使用中的许多医疗程序需要极少量的、在5到50微升范围内的血样。在所选部位上，如手指上采用穿刺方法来收集1滴或2滴血液，它与采用静脉切开来抽取一管静脉血相比，对病人来说，花费更合理和所受创伤更少。随着家用化验，如自检血糖的出现，需要一种简单的程序，可由需要化验的人员在任何设施中完成。
通常使用的刺血针一般具有一个刚性本体和一根从一端突出的消毒针。刺血针可用于穿刺皮肤，由此可从所产生的开口收集血样。把血液送到化验设备或收集设备。最普通是从指尖采血，那里的供血一般是很好的。但是，在该区的神经密度使许多病人感到明显的疼痛。有时可在其它部位，如耳垂和四肢上采样，以进入不太敏感的部位。但这些部位不易提供良好的血样，并难以把血液直接送到化验设备。
在有限表面积(如手指)上重复穿刺会形成硬结。这将增加抽血困难和增加疼痛。
为了减少对穿刺皮肤和相应疼痛的担心，已开发了许多弹簧加载装置。以下两份专利代表了在80年代开发的、用于家用诊断化验产品上的装置。
Cornell等的美国专利号4,503,856描述了一个弹簧加载的刺血针注射器。这个重复使用的装置与易处理的刺血针对接。刺血针架可锁定在退出的位置上。当使用者接触一个释放装置时，一个弹簧使刺血针以高速穿刺皮肤，然后退出。为了减少与针刺相应的疼痛，速度是很重要的。
Levin等的美国专利号4,517,978描述了一个血液采样装置。该装置也是用弹簧加载，采用了标准的易处理的刺血针。该设计可容易和精确地对手指定位，因而易于确定穿刺部位。在刺血针穿刺皮肤之后，回弹的弹簧使刺血针退到装置内的安全位置上。
在公共设施中，往往希望从病人收集到采样，然后以可控制的方式把采样送到化验装置中。例如，某些血糖检测系统需要把血样送到与化验仪器连接的化验装置中。此时，把病人手指直接放到化验装置中会造成从先前病人血液得到感染的危险。对于这种系统，特别是在医院设施中，通常穿刺一个病人皮肤，通过毛细作用把采样收集在一个小型吸管内，然后把采样从吸管送到化验装置中。
Haynes的美国专利号4,920,977描述了采用具有刺血针和小型收集管的血液收集装置。该装置把刺血针和收集容器结合成单个装置。穿刺和收集是两个分开的动作，但如果希望在使用前收集采样，该装置是一个方便而易处理的单个装置。相似的装置公开在Sarrine的美国专利号4,360,016和O’Brien的美国专利号4,924,879中。
Jordan等的美国专利号4,850,973和4,858,607公开了一种组合装置，它可根据不同构造，交替地用作注射器式的注射装置和带有易处理的实心刺血针的穿刺装置。
Lange等的美国专利号5,318,584描述了一个血液穿刺装置，用于诊断时的抽血。该发明采用了一个转动/滑动传递系统，以减少穿刺时的疼痛。使用者可容易和精确地调节穿刺深度。
Suzuki等的美国专利号5,368,047,Dombrowski的美国专利号4,654,513和Ishibashi等的美国专利号5,320,607均描述了吸入式采血器。当穿刺皮肤后、刺血针保持机构退出时，这些装置在穿刺部位和装置端部之间产生吸入作用。在从穿刺部位抽取适当采样或使用者从装置上退出之前，围绕装置端部的一个柔性垫有助于穿刺部位四周端部的密封。
Garcia等的美国专利号4,637,403和Haber等的美国专利号5,217,480公开了组合的穿刺和血液收集装置，它们采用一个薄膜来建立受创部位的真空。
Erickson等的美国专利号5,582,184描述了一个收集和测量体液的装置。该系统采用了放在一个分隔元件内的同轴注射器和毛细管。分隔元件限制了注射器的穿刺深度，并在注射器留在皮肤内时压缩注射器周围的身体组织，以改进间质液到切口的流动。但是，可以理解到，切口有闭合注射器的趋势，因而限制了可达到的任何优点。
对于单用的化验，如家用胆甾醇化验，以及对于公共场所使用，也开发了单用的装置，以消除许多病人使用时的交叉感染。Crossman等的美国专利号4,869,249和Swierczek的美国专利号5,402,798也公开了易处理的单用的穿刺装置。
作为侵入采样的替代方式，美国专利号5,421,816；5,445,611和5,458,140公开了采用超声的泵吸作用，直接从原有(无穿刺)皮肤挤出间质液。但用该法获得的液量是十分有限的。
上述发表的专利均结合在这里作为参考。
即使已作了许多改进，穿刺造成的疼痛对许多病人仍是个重要的问题。对于数百万糖尿病患者，采血的需要和对相应疼痛的恐惧也是一个主要的障碍，由于疼痛，他们不能适当地检测他们的血糖。此外，用穿刺来得到血样对其它诊断应用已更加普遍，需要有一种更少疼痛、最少侵入的装置来提高这些应用程度，并使这些技术更加得到接受。
所以，本发明的目的是提供一种装置和方法，以通过皮肤得到体液的采样，它实际上没有疼痛和极少侵入。
此外，已有的穿刺装置包括手动的按钮，一旦使用者把装置放在皮肤上，就可击发刺血针驱动机构。由于使用者知道激发刺血针的精确时刻，因而在击发瞬时使用者有突然抬高装置的倾向，这可能造成不一致的皮肤穿刺，或者可能没有穿刺。所以，本发明的另一个目的是提供一种穿刺装置，它可消除使用者方面的这种倾向。
另外，已有的支承易处理刺血针的支座形式是容许刺血针通过其下端单独地插入和卸下。为了把它向上推或向下拔，需要使用者握住刺血针的下部。由于针头从从刺血针下端突出，使用者的手靠近针头，因而有可能受到伤害和/或感染。还有，刺血针通常是靠摩擦配合保持在支座中。由于常规的制造公差，很难保证刺血针有足够的紧密配合；因而刺血针有晃动的倾向，由此在穿刺过程中增加了所受的疼痛感觉。
因此，本发明的另一个目的是提供一个消除上述缺点的刺血针支座。
本发明的另一个目的是提供一种方法，它可根据采样的部位和所穿刺的深度，取得血液或间质液的采样。尽管目前没有利用间质液(ISF)装置的商品，但可主动设法建立在ISF中的分析物，如葡萄糖与整个血液比较的关系。如果很易得到ISF，并建立了上述关系，最好把ISF作为一种采样，因为它没有红血球的干扰或调节血球比率的需要。
本发明的另一个目的是提供一种方法，它抽取少量但可调节的采样，如合适的话，一个化验装置为3微升，另一个化验装置为8微升。
本发明涉及了一种采集血液或间质液的采样装置。装置包括：一个确定纵轴的可手握的套筒，一个适于支承皮肤穿刺工具、如刺血针或激光器、在皮肤上产生切口的支座，以及一个从套筒纵向前端突出并相对于套筒作纵向运动的环。环具有一个适于与皮肤表面接触的前刺激器表面。一个可弹性变形的传力件有效地放在套筒和环之间，把力从套筒传到环，以响应套筒相对于环的向前运动，把刺激器表面压到皮肤表面上。刺激器表面的形状可压住皮肤切口周围的皮肤和身体组织的环形区，使切口鼓起和切口四周打开，由此把体液从切口压出。装置也可以省去支座，由此用单独的装置来完成穿刺。
最好是，装置的所有零件是单件，并且装配在一起时不用单独的紧固件。
环最好构成一个内环，而装置还包括围绕着内环可伸缩的外环。外环从套筒向外突出，相对于套筒可作纵向运动。一个弹簧弹性地把外环向前偏压。外环相对于套筒和内环均可沿纵向运动。
本发明也涉及了一种装置，它具有一个相对于与轴线垂直的平面为倾斜的刺激器表面。倾斜是沿径向向内和沿纵向向后。相对于平面的倾斜角为10到65度。刺激器表面的宽度最好约5mm到约20mm。刺激器表面的内径最好不小于6.0mm。
从以下参照附图对优选实施例的详细描述，本发明的目的和优点将会变得很明显，图中相同数字表示相同的零件，其中：
图1是本发明采样装置的侧视图；
图2是本发明针头组件的纵向剖面图，易处理针已装在其中；
图3是采样装置外壳件的前透视图；
图4是图3外壳的纵向剖面图；
图5,6和7均是针头组件的分解透视图；
图8是针头组件外环件的后透视图；
图9是本发明采样装置的撞击组件的分解透视图；
图10是撞击组件和图3外壳的分解透视图；
图11是采样装置外壳和套筒件的分解透视图；
图12是整个采样装置的分解透视图；
图13A-13I均是采样装置的纵向剖视图，描述了它工作顺序。
附图(如参见图1和图13A)中所示的一个最小侵入采样装置10包括了一个管状套筒12，一个管状外壳14可伸缩地装在其中。套筒12和外壳14确定了公共的纵向轴线A。外壳14包括一个前开口，可容纳一个可拆卸的刺血针针头组件16(也可参见图2)，它用于支承一个易处理的刺血针部件15(以下简称“易处理针”)，并刺激皮肤的穿刺部位，以下将作说明。
装在外壳14内还有：一个沿穿刺皮肤方向向前移动易处理针的撞击件18，一个把撞击件向后退回到击发准备(即向前受压)位置的手动把手20，以及使上述零件获得适当运动的许多弹簧。
针头组件16包括一个内环22、一个外环24、一个连接套26、一个外环弹簧28、一个支座30和一个支座弹簧32。内环22包括一个基本上为空心的圆柱体，靠近其前端具有沿径向向外突出的法兰34，在其后端具有一对向后突出的安装腿36。每条腿36包括一个相对与轴线A倾斜的倒角后表面38，每个表面38形成一个具有面朝前肩部40的钩子。内环的面朝前表面42相对于轴线为倾斜，其原因在以下将作更详细的说明。
外环24包括一个基本上为圆柱的空心体，在其外缘具有沿周向间隔的凹槽46，如后面将说明，这可使使用者更容易转动针头组件16。由于将讨论的原因，外环24的内表面上具有轴向槽47(图8)。如后面将讨论，外环24的面朝前表面48相对于轴线A为倾斜。在底面48之后相隔开的位置上，外环24上设有一个沿径向向内突出的法兰50。
内环22适于与外环24的内部作同轴配合，并使外环弹簧28安放在法兰50上。
支座30适于与内环22的内部配合，并使支座弹簧32安放在内环内部面朝后的肩部52上。设在支座30后端上的径向外法兰54靠在支座弹簧后端上。
支座30的内表面下端的直径缩小，它形成底座56，易处理针15通过支座上端向前插入后靠在底座上。
易处理针15可采用任何希望的形式，但最好是包括一个围绕金属刺血针53模制的单件塑料件。塑料件大致为X形截面，由四个朝后呈锥形的肋片55形成，由此肋片55前端靠在支座30的底座56上。塑料件也可包括一个整体模制的帽57(参见图13C)，在易处理针已装在针头装置16之后，可把它拧断，以露出刺血针53(图13D)。
连接套26包括一个柱形的开槽裙部60，它可伸缩地配合在外环内。裙部60包括轴向肋片62，它配合在外环24的槽47内，把外环和连接套锁定在一起转动。在其上端，连接套26包括一个面朝后、沿径向向内突出的肩部64(参见图13B)，它在连接套26卡到内环22的腿36上时，支承腿36的肩部40。
在连接套后端设有沿径向向外突出的法兰结构，它具有一对沿直径相对、面朝前的肩部70(一个肩部70如图7所示)，肩部相对于轴线A为倾斜。肩部70最好沿一般的螺旋线延伸。在两个肩部70之间沿周向有一对沿径向向外突出、面朝后的肩部72(一个肩部72如图7所示)，它也相对于轴线A为倾斜，例如，沿着与肩部70路线成轴向偏置的螺旋线延伸。因此在肩部70、72之间形成了沿直径相对的轴向间隙74(一个间隙74如图7所示)，使连接套可装到外壳14上，这将在下面说明。
外壳14是基本上为空心管状，并包括直径比其后区82大的前区80(参见图3和4)。前区的后端包括一对直径相对的锁定凸耳84(参见图4)。在连接套26插入外壳14的下区80之后，凸耳84位于连接套面朝后的肩部72之后(如图7所示)，在图12中顺时针方向转动连接套可使连接套的面朝前的肩部70与相关凸耳84的顶面配合，使连接套26和外壳14沿轴向收缩并锁定在一起，实际上是依靠螺纹形式的连接。
外壳14还包括一个具有面朝前肩部92的弹性指状件90(图4)，用于与套筒12内表面上的面朝后肩部94(图13A)配合，以保持外壳14在套筒12内的位置。此外，外壳14包括一个锁定凸耳96，它相对于外壳14后区82的后面部分，沿径向向外隔开，如图13A所示。该锁定凸耳96可在套筒12内表面上纵向锁定槽98内滑动，并布置成可保持撞击件18处于击发准备状态。
撞击件18滑动地装在外壳14内，并具有一个前支承面100和一对具有钩子的后安装臂102，钩子的形状使得可依靠卡紧配合，与在外壳内滑动安装的保持套104成为锁定(参见图9和13A)。撞击件18还包括一个锁定指状件106，它具有面朝前的肩部108，布置成当撞击件在击发准备状态时与外壳14的锁定凸耳96配合。锁定指状件106可在锁定槽98内滑动而防止撞击件的转动。
按钮20的舌片111通过外壳14后端内的后开口110向前延伸。舌片111包括一对弹性腿112。弹性腿112的前端形成钩子114，它布置成与装在撞击件18外缘上的圈环120前端相配合。
按钮弹簧122作用在保持套104和圈环120之间，而撞击件弹簧124作用在外壳14后面和保持套104之间。套弹簧126作用在套筒12的面朝前肩部128和外壳14的面朝后肩部130之间。
一个定位件132(图12,13A)卡在外壳14的凹槽134内。定位件132具有一个向后直径变小的中心孔136，万一采样装置10前端朝上时，用于防止易处理针15向后移动(参见图13C)。
为了装配上述装置，把内环22插入外环24中和把外环弹簧28放在内环22上，由此首先把针头组件16的零件装在一起。然后，把支座弹簧32放在内环22内，并把连接套26卡在内环的腿36上。
把圈环120在撞击件18上滑动，并把按钮弹簧122插在撞击件上，由此装配主体部分。然后把保持套104卡在撞击件18的安装臂102上，以限定它们之间的按钮弹簧122。然后把撞击件弹簧124插在保持套104上。
然后把装好的撞击分组件105插入外壳14内(参见图10)，其中锁定指状件106对准锁定槽98。然后把套筒弹簧126和套筒12放到外壳上，通过外壳后开口110把按钮20插入，使得其弹性腿112通过保持套104和按钮弹簧122，并卡在圈环120内。
把定位件132插入外壳14的凹槽134内，把针头组件16向后装入外壳内，直到外壳的锁定凸耳84与连接套的肩部72配合为止。然后，转动针头组件(依靠外环24的转动)，使得锁定凸耳84沿周向通过相关的间隙74(参见图7)。连接套的肩部26盖在凸耳84上，并把针头组件紧固在外壳内。
为了使用该装置，在图7中反时针方向转动外环24和连接套26，取下针头组件16，通过支座30后面把一个易处理针15向前插入。然后，重新安装针头组件(图13C)，用手拧断易处理针的帽57(图13D)，使刺血针53露出。
然后向后拔出按钮20，使撞击件18向后拔(图13D)。撞击件的锁定指状件106通过锁定凸耳96向上移动。此时，按钮弹簧122和撞击件弹簧124均受压缩。由此释放按钮20，按钮弹簧122向前拉按钮20，以及撞击件弹簧124向前推撞击件，直到锁定指状件的肩部108靠到锁定凸耳96为止(图13E)。现在撞击件处于击发准备状态。
现把外环24的前表面48放在使用者的皮肤S上，使用者握住套筒12，把套筒12推向使用者的皮肤S。因此，外环24相对于内环22向后移动，使外环弹簧28受压缩。这一直到内环22的前表面42与皮肤表面S配合为止(图13F)。对套筒12的进一步向下力使套筒12相对于外壳14作向前移动。此时，由套筒12的内表面区150与锁定指状件106配合并向内推，由此锁定指状件106从从锁定凸耳96上释放。这使得预先压缩的撞击件弹簧124把撞击件18向前移到易处理针15的后端(图13G)，由此易处理针与支座30一起向前移动，使支座弹簧32受压缩。当易处理针15向前移动时，刺血针53穿刺皮肤表面并在那里形成切口I，此后支座弹簧32立即使支座30和易处理针15退回(图13H)。
作用在套筒12的向前力通过压缩的套筒弹簧126、外壳14和连接套26传到内环22。因此内环22的前表面42挤压切口I周围皮肤和身体组织的环形区，使切口鼓起，并舒展切口的四周。因此，如血液或间质液的液体F由挤压的身体组织和皮肤收集和加压，使得它通过鼓起切口的开口向上移动。也就是说，挤压的皮肤和身体组织环形圈限制了液体向外流出。
当套筒12上的向前力释放时(图13I)，套筒弹簧126使套筒退回，使得内环22作用在皮肤上的力得到释放。因此，切口I的四周闭合，新鲜的液体(原先被挤压的皮肤和身体组织阻塞)流向切口，以替代已经从切口压出的液体。当对套筒以及内环再作用向前力时(参见图13H)，上述动作被重复，通过切口向上压出补充的液体。最后，这个“泵吸”作用形成了能被采样的大小适当的体液滴B。
虽然所说明的内环22的前面一般为环形，但也可以是其它形状，如椭圆或多边形，由此挤压出的身体组织圈为相似的形状。
为了得到最多的可回收体液流，已经确定了内环22的前面，即刺激器表面42的某些最佳的尺寸特性。对此，相对于与轴线A垂直的平面P，面42的倾角α应为从约10度到约65度，最好为25到65度(参见图13F)。面42的宽度W(即内环外径减去内环内径)应从约5mm到约20mm。表面42的内径应不小于6.0mm，并不大于12.0mm。由于刺激器表面42的倾斜角在上述α角范围内，可保证该表面排出充足的体液流到切口。由于内径不小于6.0mm，表面42不会与采样适当尺寸(即3微升)的血滴B接触和把它抹掉。
由于通过弹性传力件，即套筒弹簧126把向前的“泵吸”力从套筒12作用到内套上，在套筒12相对于外壳14向前运动时，作用力有延长的停顿期。这使得限制在切口I周围的更多血液或层间质液从切口向上推出。
除了针53和弹簧28、32、122、124和126外，采样装置10的零件最好由塑料制成。所有塑料零件均是单件结构(即避免把各部分胶接成一个零件)。此外，所有塑料零件不用单独的紧固件连接在一起，而采用卡紧连接或螺纹连接(如连接套26与外壳14的连接)。这大大地简化了采样装置的构造和降低了制造成本。
可以理解到，采样装置10提供了撞击件的自动击发来响应装置对皮肤的挤压。这消除了使用者在击发时刻突然抬起装置的任何可能，因为使用者不知道击发的时刻，同时保证了从一次穿刺操作到下一次操作完成同样的穿刺深度。
通过针头组件16上端装卸易处理针的能力说明，使用者可保持他或她的手远离刺血针。这保证了避免偶然的伤害，可能是受到污染刺血针的伤害。由易处理针四个突起55确定的易处理针在支座内的四点固定，建立了易处理针在支座内稳定不动的安装。因此，在穿刺过程中易处理针不会侧向运动，由此减少了使用者承受的疼痛感。
采样装置把血液或间质液之类体液泵吸到皮肤表面的能力使装置可用于在身体上对疼痛不太敏感的部位，如在耳朵部位皮肤的穿刺。
虽然结合优选实施例描述了本发明，熟悉该技术的人员可以理解到，可作出尚未具体描述的补充、修改、替代和删除，而不背离所附权利要求所规定的本发明精神和范围。

Claims (23)

1．一种采集血液或间质液的采样装置，装置包括：
一个确定纵轴的可手握的套筒；
一个适于支承皮肤穿刺工具在皮肤上产生切口的支座；
一个从套筒纵向前端突出并安装成相对于套筒作纵向运动的环，环具有一个适于与皮肤表面接触的前刺激器表面；以及
一个可弹性变形的传力件，它有效地放在套筒和环之间，把力从套筒传到环，以响应套筒相对于环的向前运动，把刺激器表面压到皮肤表面上，刺激器表面的形状可压住皮肤切口周围的皮肤和身体组织的环形区，使切口鼓起和切口四周打开，由此把体液从切口压出。
2．按照权利要求1的采样装置，其中，环构成一个内环，而装置还包括围绕着内环可伸缩的外环，外环从套筒向外突出，相对于套筒可作纵向运动；一个弹簧弹性地把外环向前偏压，外环相对于套筒和内环均可沿纵向运动。
3．按照权利要求2的采样装置，还包括一个装在套筒内相对于套筒作纵向运动的外壳，一个装在外壳内相对于外壳作纵向运动的撞击件，外壳和撞击件一起确定了一个锁定结构，把撞击件可释放地锁定在受弹簧偏压的击发准备状态，锁定结构可以释放，以响应外壳相对于套筒的向后运动。
4．按照权利要求3的采样装置，还包括一个连接套，它用卡紧结合方式与环连接，用卡口式结合方式与外壳连接。
5．按照权利要求1的采样装置，其中，刺激器表面相对于与轴线垂直的平面倾斜，倾斜是沿径向向内和沿纵向向后，相对于平面的倾斜角为10到65度。
6．按照权利要求5的采样装置，其中，刺激器表面的宽度从约5mm到约20mm。
7．按照权利要求6的采样装置，其中，刺激器表面的内径不小于6.0mm左右。
8．按照权利要求7的采样装置，其中，内径不大于12.0mm左右。
9．按照权利要求1的采样装置，其中，刺激器表面的宽度从约5mm到约20mm。
10．按照权利要求9的采样装置，其中，刺激器表面的内径从约6.0mm到约12.0mm。
11．按照权利要求1的采样装置，其中，刺激器表面的内径不小于6.0mm左右。
12．按照权利要求11的采样装置，其中，内径不大于12.0mm左右。
13．按照权利要求1的采样装置，还包括一个装在套筒内并相对于套筒作纵向运动的外壳；一个装在外壳上并支承环和支座的连接套；一个装在外壳内的圈环；一个装在外壳内与圈环向后隔开的保持套；一个有效地位于保持套和圈环之间的击发准备弹簧；一个其后端与保持套连接的撞击件；一个把撞击件向前偏压到支座的撞击件弹簧；一个手动撞击件击发准备的按钮，它具有从外壳和套筒突出的可用手握的后端，和与圈环连接的前端；外壳上形成一个挡块，把撞击件可释放地锁定在击发准备状态。
14．按照权利要求13的采样装置，其中，环和连接套形成不用单独紧固件的第一连接；连接套和外壳形成不用单独紧固件的第二连接；外壳和套筒形成不用单独紧固件的第三连接；撞击件和保持套形成不用单独紧固件的第四连接；以及击发准备按钮和圈环形成不用单独紧固件的第五连接。
15．按照权利要求14的采样装置，其中，第一，第二，第三，第四和第五连接的每一个均为卡紧连接。
16．按照权利要求1的采样装置，与装在支座中的刺血针组合；在支座后面装在套筒内的定位件用于防止刺血针的向后运动。
17．一种采集血液或间质液的采样装置，装置包括：
一个确定纵轴的可手握的套筒；以及
一个从套筒纵向前端突出并相对于套筒作纵向运动的环，环具有一个适于与皮肤表面接触的前刺激器表面，其中，刺激器表面相对于与轴线垂直的平面倾斜，倾斜是沿径向向内和沿纵向向后，相对于平面的倾斜角为10到65度，刺激器表面的宽度从约5mm到约20mm，刺激器表面的内径不小于6.0mm左右。
18．按照权利要求17的采样装置，还包括一个适于支承皮肤穿刺工具在皮肤上产生切口的支座。
19．一种采集血液或间质液的采样装置。装置包括：
一个确定纵轴的可手握的套筒；以及
一个从套筒纵向前端突出并相对于套筒作纵向运动的环，环具有一个适于与皮肤表面接触的前刺激器表面，以及
一个可弹性变形的传力件有效地放在套筒和环之间，把力从套筒传到环，以响应套筒相对于环的向前运动，把刺激器表面压到皮肤表面上，刺激器表面的形状可压住皮肤切口周围的皮肤和身体组织的环形区，使切口鼓起和切口四周打开，由此把体液从切口压出。
20．按照权利要求19的采样装置，其中，刺激器表面相对于与轴线垂直的平面倾斜，倾斜是沿径向向内和沿纵向向后，相对于平面的倾斜角为10到65度，
21．按照权利要求19的采样装置，其中，刺激器表面的宽度从约5mm到约20mm。
22．按照权利要求19的采样装置，其中，刺激器表面的内径不小于6.0mm左右。
23．按照权利要求19的采样装置，其中，刺激器表面相对于与轴线垂直的平面为倾斜，倾斜是沿径向向内和沿纵向向后，相对于平面的倾斜角为10到65度，刺激器表面的宽度从约5mm到约20mm，刺激器表面的内径不小于6.0mm左右。
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US6969359B2 (en) 2005-11-29
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FR2771277B1 (fr) 2000-08-11
US20030018300A1 (en) 2003-01-23

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