CN1525834A - 具有毛细作用的刺血针装置 - Google Patents

具有毛细作用的刺血针装置 Download PDF

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CN1525834A
CN1525834A CNA028070534A CN02807053A CN1525834A CN 1525834 A CN1525834 A CN 1525834A CN A028070534 A CNA028070534 A CN A028070534A CN 02807053 A CN02807053 A CN 02807053A CN 1525834 A CN1525834 A CN 1525834A
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lancet
main body
annular gap
test
capillary channel
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E·P·佩雷兹
S·N·罗
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Abstract

一种用于采集体液样品的装置,该装置包括一个主体(105),一个设置在所述主体内的刺血针(120),一个安装在所述主体内的、与所述刺血针连接的载体(110),一个与所述刺血针和载体连接的偏压装置(150),一个设置在所述主体内的、靠近刺血针的环形间隙(130),以及一个用于测试体液的装置。其中,所述测试体液的装置可以包括一个微孔测试条,一个电子测试装置,一个光学/反射测试测量装置,或肉眼检查。

Description

具有毛细作用的刺血针装置
本申请要求申请日为2001年1月22日的临时专利申请序列号No.60/263,533的优先权。
技术领域
本发明涉及用于获得用来分析的血液和体液样品的剖切装置和方法。
背景技术
目前使用的很多医学方法,需要少于50微升的诸如血液或间质流体的较少的体液样品。与通过切开静脉抽取一管静脉血液相比,通过剖切或穿刺诸如手指或前臂的特定部位的皮肤获得这样较少的样品,费用更低,并且对患者的损伤较小,这种方法可以采集一或二滴血液。随着用于自我监测血液葡萄糖水平的家用测试样品的出现,需要一种能够在任何场合实施的简单方法,这种方法不需要专业人员的帮助。
常规使用的刺血针,通常具有一个刚性主体,和从它的一端伸出的无菌针头。可以用所述刺血针穿刺皮肤,以便能够流出血液样品。当把毛细管或测试条放置在靠近所流出的血液放置时,就可以采集所述流体。然后通过毛细管将流体转移到诸如测试纸条的测试装置。最常见的是从手指端采集血液,在这里通常更容易获得血液。不过,由于在该部位的神经密度较高,会导致很多患者出现大的痛苦。为了减轻痛苦,有时候在诸如耳垂和肢体的其他部位取样。不过,这些部位同样不太可能提供足够的血液样品,并且使得直接将血液转移到测试装置变得更为困难。另外,用户通常也难于确定是否在切割部位流出了能提供足够样品的足够大的体液液滴。
现有获取血液样品的方法必须采用两个部件,并且会导致在剖切动作和将毛细管放置在靠近剖切部位的动作之间的时间延迟,这有可能导致污染或不能采集到从身体中涌出的体液。解决这一问题的一种现有方法是,形成一个较大的开口和/或强制从体内流出多余的流体。尽管这有助于确保提供足够的流体,但是它有可能产生需要愈合的大的开口,并且可能给患者造成额外的痛苦。另外,使用这种方法需要精确的步骤,其中,将刺血针取出,并且随后将毛细管或测试条与所述剖切部位正确对齐。为了正确采集样品,重要的是,在采集期间不能出现毛细管相对剖切部位的间隙或移动。必需一种能够辅助取出刺血针,并且以最小的时间和移动放置毛细管的系统。另外,还需要一种紧凑的、简单系统,以便获得需要大小的样品,而不必过分剖切组织,给患者造成额外痛苦或流出多余体积的体液。
为了减轻对穿刺皮肤和相关痛苦的忧虑,已经开发了很多种弹簧加载的装置。以下两份专利是这种装置的代表,它们是在上世纪八十年代开发的,用于和家庭诊断测试制品一起使用。
授予Cornell等的美国专利4503856披露了一种弹簧加载的刺血针注射器。这种可再利用的装置与一个一次性刺血针连接。可以将刺血针支架锁定在收缩位置上。当用户接触一个释放装置时,弹簧会导致所述刺血针高速剖切皮肤,并且随后缩回。为了减轻与穿刺相关的痛苦,速度是重要的。
授予Levin等的美国专利4517978披露了一种血液取样仪器。该装置也是弹簧加载的,它使用一个标准的一次性刺血针。这种设计可以方便地进行精确地相对指端定位,以便可以方便地确定冲击位点。在刺血针穿刺皮肤之后,由一个反弹弹簧将一个刺血针收回到该装置内的一个安全位置。
在家庭使用中,通常需要采集样品,以便用户能够在家庭进行测试,如监测葡萄糖。例如,某些血液葡萄糖监测系统需要将血样添加到与测试仪器接触的测试装置上。在这种场合下,使手指接触测试装置会造成以前的样品污染所述样品的危险,所述以前的样品可能是没有从该装置上适当清除的样品。
葡萄糖监测装置以多种方式使用血液样品,不过,两种最常用的方法是纸条和毛细管。使用纸条的监测器需要患者穿刺手指或适当部位,从所述穿刺点抽取少量血液样品,如通过挤压,然后将所述纸条放置在所述血样上,并且等待直到所述纸条吸收了所述血液。使用毛细管的监测器需要患者按上述方法操作,所不同的是,不是用纸条从皮肤上采集血液。相反,将一个小的毛细管放置在所述样品上,直到将足够数量的血液抽取到该毛细管中,然后进行测试。
在某些场合下,患者是糖尿病患者,这样的患者不能适当代谢葡萄糖。为了调节其体内的胰岛素水平,糖尿病患者必须向体内注射合适数量的胰岛素。为了确定合适数量的胰岛素,首先必须测试患者的血液葡萄糖水平。通常,必须用刺血针‘穿刺’患者指端,以便形成一个切口,可以通过该切口抽取血液,并且放置在葡萄糖监测条上,然后血液和监测条起反应,并且改变颜色,从而指示葡萄糖水平。
Haynes的美国专利4920977披露了一种具有刺血针和微型采集试管的血液采集组件。该装置将刺血针和采集容器整合在单一装置上。剖切和采集是两个独立的动作,但是该装置是一种方便的一次性装置,适合需要在使用之前采集样品的场合。在Sarrine的美国专利4360016和O’Brian的美国专利4924879中披露了类似的装置。
Jordan等的美国专利4850973和4858607披露了一种组合装置,还可根据其设计将其用作注射器类型的注射装置或具有一次性实心针头刺血针的剖切装置。
Lange等的美国专利5318584披露了一种用于抽取供诊断使用的血液刺血针装置。该发明使用一种旋转/滑动转变系统来减轻剖切的痛苦。用户可以方便地和精确地调整穿刺深度。
Suzuki等的美国专利5368047,Dombrowski的美国专利4654513和Ishibashi等的美国专利5320657各自披露了吸力型血液取样器。该装置在穿刺皮肤之后,通过刺血针固定机构的抽吸,在剖切部位和该装置末端之间产生吸力。位于该装置末端周围的柔性垫圈,有助于将该装置密封在剖切位点周围,直到从所述剖切位点抽取了适量的样品或者用户将该装置拿开。
Garcia等的美国专利4637403披露了一种组合的剖切和血液采集装置。该装置使用毛细作用通道将体液引导至微孔膜形式的独立的测试条。必须实现所述毛细通道上端相对所述膜的精确定位,以便确保来自所述通道的体液被转移到所述膜上。如果在它们之间存在大的间隙的话,就不能进行转移。另外,所述毛细通道的直径较小,因此转移到所述膜上的样品宽度可能太小,以至不能通过诸如光学测试系统或电化学仪器的现场测试装置诊断。
还开发出了用于一次测试用途的一次性装置,即,用于家庭胆固醇测试,和用于公共用途,以便消除多个患者使用造成的患者交叉感染的危险。Crosman等的美国专利4869249和Swierczek的美国专利5402798披露了一次性的、一次使用的剖切装置。
上述专利的内容被收作本文参考。
本发明的一个目的是提供一种一次性刺血针装置,该装置可以方便地布置,并且不会导致过度的痛苦。
本发明的另一个目的是提供一种用于采集供测试使用的体液样品的一个步骤的系统。
本发明的另一个目的是提供一种能抽取血液样品,并且能给用户提供血液葡萄糖水平读数的装置。
本发明的另一个目的是提供一种用户不需要进行多个步骤就能产生血液葡萄糖水平读数的装置。
本发明的再一个目的是提供一种具有毛细作用的刺血针装置。
通过本文所提供的详细的附图和说明,可以了解本发明的其他目的、特征和优点。
发明内容
在所述优选实施方案中,本发明提供了一种将剖切部件和毛细部件整合成单一装置的装置,该装置可以剖切人体皮肤,并且获得通过剖切所产生的体液。本发明采用了一种分布在所述毛细部件内的剖切部件,并且所述体液经所述剖切部件和所述毛细管内壁之间的间隙通过所述毛细部件。
本发明的一方面涉及一种用于采集体液样品的取样装置。该装置包括一个刺血针,一个主体和一个用于移动所述刺血针的载体装置。该装置形成了一个围绕所述刺血针的环形间隙,以便通过毛细作用将体液吸入该环形间隙。在一种实施方案中,该系统还包括一个具有一种试剂的测试条。在一种方法中,所述测试条与所述环形间隙的远端形成流体连通。在另一种方法中,所述测试条被放置在位于刺血针和主体之间的环形间隙内。在一种优选实施方案中,所述测试条包括微孔膜。
在另一种实施方案中,所述取样装置包括一个主体、一个刺血针、一个用于所述刺血针的载体,以及位于所述刺血针内的、用于支承测试条的至少一个通道。在本实施方案中,当填充所述环形间隙时,体液接触所述测试条。
在另一种实施方案中,所述取样系统包括一个主体,一个刺血针,一个用于所述刺血针的载体和一个测试装置。所述刺血针安装在所述主体内,以便在所述刺血针和所述主体之间限定一个环形间隙,并且,所述刺血针可以前进和后退,以便流体可以填充所述主体。所述主体移动到或连接到一个测试装置上,以便对所述流体进行光学或电化学测试。
在另一种实施方案中,所述取样系统包括一个安装在一个底座单元上的一次性容器。所述底座单元包括用于驱动位于毛细管部件内的刺血针的驱动结构。所述底座单元优选能够再利用,并减少了所述容器中的材料和结构。
本发明还涉及一种采集体液样品的方法,该方法包括以下步骤:将所述测试装置放置在测试部位,驱动装有刺血针的装置,以便所述刺血针在所述测试部位形成一个小的切口,体液可以通过该切口流出,将所述体液吸入所述装置的主体中,以便与测试条或传感器接触,为用户提供所述结果。
附图说明
图1A是根据本发明优选实施方案的一种装置的剖视侧视图;
图1B是图1A所示装置的仰视图;
图1C是沿图1A中线A-A的剖视图,表示放置在所述测试装置内的测试条;
图2A,2B和2C是处在使用状态的权利要求1所述装置的剖视侧视图;
图3A是本发明另一种优选实施方案的剖视侧视图;
图3B是图3A的另一种实施方案的仰视图,表示放置在所述环形间隙内的测试条;
图4A是本发明另一种优选替代实施方案的剖视侧视图;
图4B是图4A所示替代实施方案的仰视图,表示放置在刺血针上的槽内的测试条;
图4C是本发明剖切和测试装置的另一种实施方案的仰视图;
图4D是本发明装置的另一种实施方案的仰视图;
图4E是本发明装置的另一种优选实施方案的仰视图;
图4F是本发明另一种优选实施方案的剖视侧视图,表示一种双刺血针装置;
图4G是图4F所示另一种实施方案的剖视端视图;
图4H是本发明刺血针的另一种实施方案的剖视侧视图;
图5A是本发明装置的另一种实施方案的剖视侧视图;
图5B是安装在一种测试装置上的图5A所示装置的侧视图;
图6A是本发明装置的另一种实施方案的剖视侧视图;
图6B是放置在组织表面上的图6A所示装置的剖视侧视图;
图6C是表示具有所述设计的毛细作用的图6A所示装置的剖视侧视图;
图7是本发明装置的另一种实施方案的剖视侧视图;
图8A和8B是本发明装置的另一种实施方案的剖视侧视图;
图8C是图8A和8B的装置的分解示意图;
图9A是本发明装置的另一种实施方案的剖视侧视图;以及
图9B是图9A所示装置的分解示意图。
具体实施方式
为了更好地理解本发明的原理,下面将参考所示出的实施方案,并且要使用特殊语言描述所述实施方案。不过,应当理解的是,这种说明不是要限定本发明的范围,所述改变、改进,以及本发明原理的其他应用,对于本发明所属领域的技术人员来说是显而易见的。
本发明提供了一种用于获得少量体液样品的装置和方法。在本发明的优选实施方案中,将剖切部件与毛细部件整合成单一装置,用于剖切人体皮肤,并且获取通过所述剖切所产生的体液。本发明采用了一种分布在所述毛细部件内的剖切部件,并且所述体液从所述剖切部件和所述毛细部件内壁之间的空隙中通过所述毛细部件。这种一体化装置可以单独使用,或者与其他装置组合使用,所述其他装置具有互补性功能,如促进体液从切口中排出,收集并分析或测试所述流体。所述装置可以是可再利用的或一次性装置。
与现有技术不同,本发明将刺血针安装在所述毛细部件内,以便在刺血针伸出,形成切口之前,所述毛细管部件被放置并且集中在所述切口上面。这样,消除了在形成切口之后移动所述毛细部件的必要性,并因此降低了在将毛细管快速而又准确地转移到切割部位时可能遇到的突出的困难。因此,它增强了获得所排出的体液的能力,而没有损失、延迟或污染。
鉴于上述目的和优点,本领域技术人员应当理解的是,用于伸出和收回刺血针,以及保持所述毛细管的具体机制,对本发明来说并不重要,不过,用下文所披露的特定实施方案获得了某些优点。因此,正如本领域所公知的,构成本发明基础的潜在概念可用于多种剖切机构。例如,本发明可用于与用来相对外壳延伸和收缩刺血针的机构组合,例如,在被收作本文参考的专利申请PCT/EP01/12527和美国专利申请流水号09/963967中所披露的。以上说明构成了本发明说明书的一部分,并且构成了其可以利用的设计替代方案。
本发明适用于各种体液。例如,所述装置适用于接触血液或间质体液。通过控制所述剖切部件在伸展状态下延伸到用户皮肤中的距离,可以将该装置方便地设计成适合任一种流体。例如,0.5-2.5毫米的深度通常会产生血液。
在图1A、1B和1C中所示出的一种优选实施方案中,装置100包括主体105,它具有便于该装置使用的相关的特征。主体105是一个毛细管部件,它具有利用毛细作用从接触的来源吸取并保持流体的内部直径尺寸。主体105包括用于支承刺血针120,并且用于在第一收缩位置和第二伸展位置之间纵向移动所述刺血针的内部结构。装置100还可以包括与下文所述的测试体液相关的装置。
详细参见图1A,图中示出了一种用于测试体液的基本的、一体化装置100。装置100包括一个主体105,具有远点135的刺血针120,偏压装置150,和刺血针载体或中心体110。在主体105内形成环形间隙或空隙130,并且该间隙位于刺血针120和主体105的内壁之间。在本文中,该间隙一般被称作“环形”间隙,不过,应当理解的是,所述间隙的形状可以根据刺血针和毛细部件的形状以及刺血针在所述毛细部件内的位置而改变。
对本发明来说,术语环形间隙被理解成总体上包括所述毛细部件和所容纳的刺血针之间的间隙,包括在所述刺血针和毛细部件之间可能出现的间隙的多种物理形状,这种形状至少部分取决于所述可能的变化。在某些优选实施方案中,刺血针120和主体105之间的环形间隙130为10-500微米,并且优选为20-200微米,以便获得血液的最佳毛细填充时间。
下面参见图1B,图中示出了装置100的仰视图。图1B表示位于刺血针120和主体105之间的环形间隙130。在使用时,环形间隙130发挥毛细作用,通过这种作用将体液通过装置100吸上来,进入环形间隙130,使排出的空气通过主体105的相反一端从该装置中溢出。设计主体105和刺血针或剖切部件120的大小和排列,以便通过毛细作用提供需要的体液流。这在某种程度上取决于所述对象体液,并且取决于其他参数。
另外,通过用亲水性材料生产所述剖切部件和/或所述毛细部件的内表面,可以加强所述流体流,所述亲水性材料已经做过亲水性处理,或者已经用诸如表面活性剂或亲水性聚合物的亲水性材料进行过涂覆。所述表面还可以通过聚酰胺、氧化(例如,电晕/等离子处理);等离子化学气相沉积;金属、金属氧化物或非金属氧化物的真空气相沉积;或由水氧化的元素的沉积处理过。因此,所述环形间隙的大小,能够通过毛细作用提供需要的液体流,将各种影响因素都考虑在内。
可选择性地在所述测试条和所述毛细通道远端之间放置一个吸收垫,用于将体液从所述环形间隙吸收到所述测试条。在所述测试条被放置在所述环形间隙内的实施方案中,不需要吸收垫,因为所述测试条能直接接触所述体液。
所述剖切部件或刺血针120被容纳在装置100的毛细间隙130内,并且可以在第一收缩位置和第二伸展位置之间纵向移动。提供用于弹性伸展和收缩所述刺血针的装置,以便形成一个需要的切口,并且随后将所述刺血针收回到受保护的位置。
有多种用于相对外壳伸展刺血针的装置为本领域所公知,并且可以与本发明组合使用。例如,所述装置通常包括由载体保持的刺血针,该载体是由弹簧加载的,以便相对周围的外壳移动。另外,可以用一个弹簧加载的锤子冲击所述刺血针载体,以便沿所述方向驱动刺血针,从而剖切皮肤。所述机构的例子包含在以下美国专利中:5951492;5857983和5964718。以上说明被收作本文参考,并且构成本发明说明书及其可使用的设计方案的一部分。
所述装置通常将刺血针伸展到特定程度,例如将刺血针移动到一个阻挡部件。所述装置通常被制造成具有刺血针的预定运动极限,以便限定刺血针进入皮肤的深度。另外,使用者能够调整穿刺深度的装置是众所周知的,例如通过转动一个轮或其他机构进行调整,这种可调整的装置通常包括一个显示选定深度的表盘或其他显示器。这种类型的机构可以与本发明组合使用。
在刺血针形成切口之后,可以类似地用各种装置将刺血针收回,并且有多种这样的机构为本领域所公知,包括前面所引用的并且被收作本文参考的文献。收缩装置的一种例子是环绕刺血针120的弹簧150(图1),它被放置在与主体105相关联的支承表面或保持器107和与刺血针120相关联的支承表面或保持器122之间。优选的支承表面107和122是销子、突片、凸缘、圆环或类似结构,它能提供足够的支承表面将弹簧150保持就位,而又不会显著妨碍毛细流体流动。
安装所述弹性装置,以便提供在形成切口之后将刺血针收回到所述主体内的相对运动。诸如弹簧150的弹性装置优选是用生物相容性材料制成的,如本领域公知的金属、塑料、弹性材料或类似材料,所述材料不会与所述样品发生反应或干扰该测试方法。如果所述装置被反复使用的话,所述弹性装置是可以多次使用的,或者对于所述装置的一次性或一次使用的实施方案来说,可以是一次性的或一次使用的机构。
可以将所述弹性装置安装在各种位置上,而又不影响该装置的操作。例如,可以将所述弹簧放置在所述主体下部(图1A),所述主体上部(图4A),所述主体外部,位于该主体和刺血针支架之间(未示出),或安装在保持该装置的外部结构外面(图7)。在另一种实施方案,可以将所述弹性装置设计成能提供膨胀或收缩力,以便将所述刺血针移动到其收缩位置。因此,举例来说,用于收缩刺血针的装置将刺血针推或拉至所述收缩位置。
所述刺血针的收缩还可以是全面收缩或仅仅是部分收缩。在进行全面收缩时,所述刺血针被从所述切口中取出,并且送回到防止用户意外接触的收缩位置。不过,在另一种方法中,所述刺血针也可以仅仅是部分收缩,以便将一部分刺血针留在切口内。当所述刺血针仅仅是部分收缩时,所述刺血针起着定位血液的焦点作用,并且将血液转移到所述毛细管部件中。可以通过这种方法由刺血针确保所述切口保持开放,以便血液或其他体液从该切口中流出。
下面参见图1C,图中示出了沿图1A的线A-A的装置100的剖视图。装置100还包括一个测试部件,如试剂测试条90和测试条支架140。测试条支架140是主体105的壁上的一个孔或槽,以便可以将测试条90插入装置100,并且容纳在环形间隙130内,以便测试条90是在刺血针120周围径向放置的。在刺血针按所述方式移动期间,可以将测试条90保持就位,或者可以在刺血针伸展和收缩期间随刺血针120一起纵向移动。正如在以下实施方案中所示出的。总之,装置100的毛细作用将体液吸入环形间隙130,以便所述体液接触所述测试条。
主体105可以用任何合适的材料制成,并且,通常可以用塑料、玻璃或各种其他材料经济地生产,例如,通过注模或挤压生产。所述主体可以用诸如玻璃、塑料、聚氯乙烯或任何类似生物相容性塑料的透明材料制成。另外,所述主体可以生产成具有不透明的或固体外表面。在某些实施方案中,需要所述毛细部件是透明的,或包括一个窗口部分,以便用户能够观察流体填充毛细管的过程和/或便于观察对所述体液的测试,特别是通过光学装置观察。
刺血针120和弹簧150可以用诸如钢材、手术不锈钢、铝或钛,以及本领域已知的其他合适材料的任何生物相容性材料制成。刺血针120优选被制成固体部件,它足够锋利,以便能形成切口。
装置100优选以紧凑的尺寸生产,使环形间隙130的大小能够容纳所需要的流体样品大小。尽管所需要的样品大小会根据要采集的流体样品和需要的具体测试而改变,在优选实施方案中,样品的体积是较小的,并且可以小到3微升或更少,包括少于1微升。为了运输和使用,装置100可以单独包装,或者可以装在盒子类型的容器中,可以将它安装在施加器上,以便根据需要进行多次测试。
通过使用套在所述毛细部件远端的盖子(图5A)或其他密封部件,可以提高该装置的无菌性。在一种实施方案中,将一个盖子保持在所述毛细部件上,以便在使用之前密封所述刺血针。在使用该装置时只需简单地去掉所述盖子。在另一种实施方案中,将一个塑料部件包围在所述顶端,并且将所述塑料的一部分扭曲、切割或撕掉,以便露出其顶端,方便使用。
在另一种方法中,将一种膜放置在所述毛细部件远端,以便提供对该装置的密封。该膜由合适的材料组成,在使用时所述刺血针可以延伸通过该膜。因此,在使用时不必去掉所述密封膜,相反,它足够薄,并且可以穿透,以便当所述剖切部件从收缩位置移动到伸展位置时它保持在原处。在随后的实施方案中,所述密封膜优选是生物相容性的,并且应当不会干扰所述剖切部件剖切皮肤或导致毛细流体流动的预期功能。所述顶端的一种例子披露于专利申请PCT/EP01/02198中。
在图2A、2B和2C所示出的用途中,装置100的远端被放置在诸如前臂或指端的合适的剖切位点上,以便所述远端贴在皮肤表面上。由此提供了一种位置控制,以便能够施加预定的(选择的)穿刺深度。在其收缩位置上,所述剖切部件的远端135被完全纳入装置100,避免了意外接触其顶端。然后,在刺血针载体110上施加一个向下的力D(图2B),将刺血针120从图2A所示静止的、受保护的位置,移动到图2B所示的伸展位置。在所述伸展位置上,刺血针120的顶端135刺入皮肤组织,从而形成一个小的切口,切口通常为0.5-1.2毫米深。所述切口深度通常被预定为所需深度,或者可以通过该装置上所包括的可选择深度的调节机构控制。
然后解除作用在刺血针载体110上的力D,并且由弹簧150将刺血针120偏压到图2C所示的收缩的和受保护的位置。如图2C所示,在收缩之后,装置100保留在新形成的切口上,优选不移动,并且,通过毛细作用将体液F吸入装置100的环形间隙130。由于所述毛细部件就在原位,并且与所述切口对齐,使得所述毛细作用更有效,减少了有关移动或组织与毛细部件之间的间隙的问题。将足够体积的体液F吸入环形间隙130,以便可以收集、测试和/或分析,例如,通过与测试条90接触进行分析。在另一种使用方法中,用其他工具协助将足够体积的流体从所述切口部位排出,这种做法是众所周知的。
流体的测试可以用标准光学或电化学方法进行。所采集的流体可以用任何现有方法和设备分析,包括常规测试条化学方法。例如,在一种实施方案中,在体液F接触微孔测试条90之后,测试条90可以进行原位光学读数,或者在取出后测定,例如测定血液葡萄糖水平。通常,将所述测试条的光学读数与对照表上的测试条的反应颜色进行比较。另外,可以将测试条90从装置100上取出,并且与化学或电子测试装置连接或放置在所述装置内。在另一种实施方案中,装置100包括设置在刺血针120表面上的或设置在主体105内部周边的光学可读的、活性涂层。体液F的测试可以通过对所述涂层与所述体液的反应结果的光学读数完成。
另一种实施方案的装置包括多个测试装置,例如两个或更多个测试条90,并且包括另一种结构设计。参见图3A和3B,示出了装置100的另一种实施方案。装置300在结构和材料上与装置100类似,并且包括一个外部主体305,具有远端335的刺血针320,刺血针载体310,弹簧350,弹簧支承表面或保持器307和322,和环形间隙330。如图3A和3B的俯视图所示,装置300还包括测试条支架340,和放置在环形间隙330内的测试条90。在使用时,通过接触测试条90的毛细作用,将体液吸入环形间隙330。可以重复设置多个测试条90,以确保准确性,或者可以包括不同的试剂,以便同时进行多种测试。
参见图4A和4B,图中示出了本发明装置的另一种实施方案。在该实施方案中,装置400包括主体405,刺血针420,刺血针载体410,弹簧450,弹簧保持装置407,沿刺血针420轴向设置的槽422,和环形间隙430。如图4B所示,将测试条90放置在刺血针420的槽422内。尽管所示出的刺血针420仅具有一个槽422,和一个测试条90,刺血针420可以包括多个槽和测试条,以便实施本发明的方法。
参见图4C、4D和4E,示出了装置400的另一种实施方案400’,400”和400。如图4C所示,刺血针420’包括第一和第二个槽422’,各自适合容纳测试条90(未示出)。参见图4D,刺血针420”包括具有V形形状的、适合容纳测试条90(未示出)的槽422”。另外,如图4E所示,装置400的主体405包括适合容纳并且携带测试条90(未示出)的槽422。另外,可以在槽422中设置活性涂层。在图4C、4D和4E所示出的每一种实施方案中,所述装置各自包括图4A所示出的主要装置部件。
参见图4F和4G中的另一种实施方案,图中示出了具有主体405F的装置400F,第一和第二个刺血针420F,环形间隙430F,第一和第二个刺血针远端435F,和在第一和第二刺血针420F之间形成的通道422F。可以将测试条90F放置在通道422F内,以便将测试条放置在与所述体液空间连通的位置上,使体液向上运动进入所述毛细管。另外,推进刺血针420F,同样推进测试条90F。
图4H表示另一种实施方案——装置400H。刺血针420H包括设置在它上面的通道422H。可以将通道422H用于将体液推进到靠近所述通道近端放置的测试条。另外,将测试条90H放置在通道422H内。
在图5A和图5B所示的另一种实施方案中,装置500包括主体505,刺血针520,刺血针载体515,环形间隙530和偏压机构550。在使用时(未示出),将装置500放置在要采集体液样品的部位上方,通过对刺血针载体510施加向下的力D,在主体505内推进刺血针520。刺血针520的远端535穿刺组织,以便形成一个小的切口,体液可以通过该切口流出,然后解除作用在刺血针载体510上的力D,以便由偏压或弹性机构550将刺血针520收回到主体505内。体液由通过所述刺血针形成的切口,通过毛细作用流入环形间隙530。
在将足够数量的体液吸入环形间隙530之后,将装置550放入分析设备,如图5B所示的血液葡萄糖测定装置580。所述分析设备可以使用光学透射率、反射率、荧光或通过电和/或化学刺激直接取样,以便用常规方法测试所述流体样品。例如,在一种简单的测试机器上,血液葡萄糖水平是通过以下方法获得的:按下测试装置580上的按钮585,使血液葡萄糖水平显示在显示器590上。
在图5A和5B中所示的另一种实施方案中,可以将电化学传感器或电极560安装在环形间隙130内。传感器560通过电线565与测试设备580连接,以便对体液进行分析。可以在获得流体之前将所述传感器连接在所述测试设备上,或者可以移动装置100并且放置到所述测试设备内或与所述测试设备连接。
在图6A和6B中示出了装置100的结构的其他变化形式。装置600包括主体605,刺血针620,环形间隙630和放置在主体605末端的安全帽618。在该实施方案中,将刺血针620固定在所述主体上,并且不能相对移动。如图6A所示,在装置600上,刺血针620的远端635略微伸出主体605的远端607。通常,刺血针620远端635和主体605之间的距离为0.05-2毫米,优选0.5-1.2毫米。
在图6B所示的用途中,在安全帽618从主体605的远端607上取下之后,将装置600放置在将要抽取体液的需要的部位上方,即前臂或指端。对主体605的近端604施加一个力,迫使刺血针620的远端635刺入组织,并形成一个小的切口,体液可以通过该切口流出。如图6C所示,然后将装置600略微从所述组织部位上收回,以便形成一小滴体液,并且通过毛细作用将该体液吸入环形间隙630。然后可以用本文所披露的各种方法测试所述流体。
在图7中示出了另一种实施方案,它具有保持在底座740上的一次性装置700。装置700包括主体705,它具有安装在载体710上的刺血针720。主体705优选通过诸如摩擦配合(如图所示)或其他连接的合适方式,可拆卸地保持在底座740的内壁745上。载体710延伸到一个注射器部件或柱塞760,并且可以通过摩擦配合、螺纹结合、形状配合、锯齿配合(如PCT/EP01/12527中所披露的)、卡接或类似结合连接。将弹簧750安装在底座740的支承表面707和注射器760的支承表面722之间。在本实施方案中,该组件提供了较大的抓握面积,以便使用,同时可以反复使用底座,并且减少了一次性装置700的内部结构和部件。可以使用各种底座单元设计,例如“笔形”注射器。
在图8A,图8B和8C中示出了另一种优选实施方案。装置800包括与远端主体部分807连接的近端主体部分805。与刺血针820连接的载体810被放置在近端主体805内,使刺血针820通过远端主体807伸出远端。在远端主体807内限定毛细通道830,并且形成一个从主体部分807的远端延伸到测试部件支架860的环形间隙。测试元件支架860优选是主体部分807上的一个侧口,用于容纳诸如测试垫890的介质。
在图9A和9C中示出了另一种优选实施方案。装置900包括与远端主体部分907连接的近端主体部分905。与刺血针920连接的载体910放置在近端主体部分905内。毛细管930环绕刺血针920,并且将一个环形间隙容纳在远端主体部分907内。毛细管930从主体部分907的远端延伸到测试部件支架960。测试部件支架960优选是主体部分907上的一个槽或侧面开口。
尽管在附图和上述说明中已经对本发明进行了详细说明和描述,这些说明和描述被认为是说明性的,而不是限制性的,应当理解的是,不仅是已经图示和说明的优选实施方案,而且在本发明实质范围内的所有改变和改进都希望受到保护。

Claims (43)

1.一种用于采集体液样品的装置,包括:
a)限定一个毛细通道的主体;
b)设置在所述毛细通道内的刺血针,并且在所述刺血针和所述主体之间限定一个环形间隙;
c)其中,所述刺血针是可以选择性地推进和收回的;和
d)其中,所述毛细通道的尺寸使得可以通过毛细作用将体液吸入所述环形间隙。
2.如权利要求1所述的装置,还包括至少一个与所述环形间隙连通的测试部件。
3.如权利要求2所述的装置,其中,所述测试部件是测试条。
4.如权利要求3所述的装置,其中,所述测试条是一种膜。
5.如权利要求3所述的装置,其中,所述测试条是环绕所述刺血针径向安装的。
6.如权利要求3所述的装置,其中,所述测试条被安装在限定于所述刺血针内的槽中。
7.如权利要求3所述的装置,其中,所述测试条被安装在限定于所述主体内的槽中。
8.如权利要求2所述的装置,还包括两个或更多个与所述环形间隙连通的测试部件
9.如权利要求2所述的装置,其中,所述测试部件包括位于所述环形间隙内的电化学传感器。
10.如权利要求2所述的装置,还包括选择性地收回所述刺血针的偏压装置。
11.如权利要求10所述的装置,还包括选择性地推进所述刺血针的偏压装置。
12.如权利要求10所述的装置,其中,所述偏压装置是可以操纵的弹簧,以便提供所述刺血针和所述主体之间的相对运动。
13.如权利要求12所述的装置,其中,所述弹簧被安装在所述主体上的支承表面和所述刺血针上的支承表面之间的所述毛细通道内。
14.如权利要求13所述的装置,其中,所述弹簧包括一种生物相容性材料。
15.如权利要求2所述的装置,其中,所述主体具有一种大体上为筒状的形状。
16.如权利要求15所述的装置,其中,所述主体包括一种生物相容性塑料。
17.如权利要求3所述的装置,其中,所述测试条是光学反应性的。
18.如权利要求17所述的装置,其中,所述主体的靠近所述测试条的至少一部分是透明的。
19.如权利要求17所述的装置,其中,所述主体是透明的。
20.如权利要求2所述的装置,其中,所述主体限定一个通向所述毛细通道的远端开口,并且,其中,所述装置还包括一个覆盖所述开口并且可以由所述刺血针穿透的顶端。
21.如权利要求2所述的装置,其中,所述刺血针由所述主体推进大约0.05-3毫米的距离。
22.一种用于采集体液样品并且测试的系统,包括:
a)限定一个毛细通道的主体;
b)设置在所述毛细通道内的刺血针,并且在所述刺血针和所述主体之间限定一个环形间隙;
c)其中,所述刺血针是可以选择性地推进和收回的;
d)其中,所述毛细通道的尺寸使得可以通过毛细作用将体液吸入所述环形间隙;和
e)用于测试被吸入所述毛细通道中的体液的测试装置。
23.如权利要求22所述的系统,其中,所述测试装置包括至少一个与所述环形间隙连通的测试部件。
24.如权利要求22所述的系统,其中,所述测试装置包括可操作地测试所述环形间隙中的体液的分析设备。
25.如权利要求25所述的系统,其中,所述测试装置还包括安装在所述环形间隙内并且与所述分析设备连通的电化学传感器。
26.如权利要求24所述的系统,其中,所述主体在采集体液样品之后被放置到所述分析设备内。
27.如权利要求26所述的系统,其中,所述测试装置利用光学透射率、反射率或荧光测试所述体液。
28.如权利要求26所述的系统,其中,所述测试装置利用定位成与所述环形间隙连通的电化学传感器测试所述体液。
29.一种用于采集体液样品的装置,包括:
a)底座单元;
b)可安装在所述底座单元上的一次性主体,并且限定一个毛细通道;
c)设置在所述毛细通道内的刺血针,并且在所述刺血针和所述主体之间限定一个环形间隙;
d)与所述底座单元相关联并且可释放地与所述刺血针连接的注射装置,其中,所述注射装置可操作成选择性地推进和收回所述刺血针;和
e)其中,所述毛细通道的尺寸使得可以通过毛细作用将体液吸入所述环形间隙。
30.如权利要求29所述的装置,还包括与所述环形间隙连通的测试装置,用于分析所述体液。
31.如权利要求30所述的装置,其中,所述测试装置包括与所述底座单元相关联的电化学测量设备。
32.一种用于从人体内获得流体样品的方法,包括以下步骤:
a)将具有一个限定的毛细通道的装置靠近组织放置在需要采集样品的部位处;
b)推进设置在所述毛细通道内的刺血针,以便所述刺血针在所述需要的取样部位的切割点上切割组织;
c)将所述刺血针收回所述毛细通道;和
d)通过毛细作用,将在切割点从所述身体挤出的体液收集到所述毛细通道内。
33.如权利要求32所述的方法,还包括以下步骤:测试所获得的体液,同时所述体液被容纳在所述毛细通道内。
34.如权利要求32所述的方法,还包括以下步骤:将所述流体从所述毛细通道转移到测试部件并随后测试所述流体。
35.如权利要求32所述的方法,还包括以下步骤:利用与所述毛细通道连通的测试装置测试所获得的体液。
36.如权利要求33所述的方法,还包括以下步骤:测试所获得的体液的血液葡萄糖水平。
37.一种用于测量血液葡萄糖水平的装置,该装置包括:
a)一个主体,它具有大体上为筒形的形状,一个近端和一个远端;
b)设置在所述主体内的刺血针,其中,一个环形间隙设置在所述刺血针周围并且由所述主体限定,并且,所述刺血针突出超过所述主体的所述远端;和
c)与所述环形间隙连通的用于测试血液葡萄糖水平的装置。
38.如权利要求37所述的装置,其中,用于测试血液葡萄糖水平的所述装置包括靠近所述主体的所述近端设置的电子测量仪,并且具有与所述环形间隙连通的传感器。
39.一种用于采集体液样品的方法,包括以下步骤:
a)提供一种测试装置,它具有一个限定毛细通道的主体,和一个设置在所述毛细通道内的刺血针,并且在所述刺血针和所述主体之间限定一个环形间隙;
b)将测试装置放置在将要切开的部位的上方;
c)将所述刺血针推进到所述部位,以便形成一个切口;和
d)通过毛细作用将体液吸入所述环形间隙。
40.如权利要求39所述的方法,还包括以下步骤:在抽取体液之前将所述刺血针从所述切口收回。
41.如权利要求40所述的方法,其中,所述刺血针从所述部位收回0-2毫米。
42.如权利要求39所述的方法,其中,所述刺血针可以相对所述主体移动。
43.如权利要求39所述的方法,其中,所述刺血针的位置是相对所述主体固定的。
CNA028070534A 2001-01-22 2002-01-22 具有毛细作用的刺血针装置 Pending CN1525834A (zh)

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CN101155550B (zh) * 2005-04-07 2010-05-19 霍夫曼-拉罗奇有限公司 用于取出体液的装置
CN101816563B (zh) * 2005-04-07 2012-06-27 霍夫曼-拉罗奇有限公司 用于取出体液的方法和装置
CN101036581B (zh) * 2006-03-13 2010-05-26 希森美康株式会社 微孔形成系统
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US20020103499A1 (en) 2002-08-01
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WO2002056751A3 (en) 2002-11-07
US20100145229A1 (en) 2010-06-10
JP2004522500A (ja) 2004-07-29
PL364604A1 (en) 2004-12-13
CA2435439A1 (en) 2002-07-25
US7803123B2 (en) 2010-09-28
KR20030079958A (ko) 2003-10-10
BR0206604A (pt) 2004-02-17
US6866675B2 (en) 2005-03-15
AU2002247008B2 (en) 2006-02-09
EP1355573A4 (en) 2005-08-24
US8257276B2 (en) 2012-09-04
MXPA03006421A (es) 2004-12-02
EP1355573A2 (en) 2003-10-29

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