CN1925789A - 用于进行电刺激以提高刺血装置性能的方法和设备 - Google Patents

用于进行电刺激以提高刺血装置性能的方法和设备 Download PDF

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CN1925789A
CN1925789A CNA2005800067320A CN200580006732A CN1925789A CN 1925789 A CN1925789 A CN 1925789A CN A2005800067320 A CNA2005800067320 A CN A2005800067320A CN 200580006732 A CN200580006732 A CN 200580006732A CN 1925789 A CN1925789 A CN 1925789A
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F·A·陈
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F Hoffmann La Roche AG
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
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    • 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
    • A61B5/150091—Means for enhancing collection by electricity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • 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
    • A61B5/150106—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61B5/15121—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 piezos
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/15123—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 magnets or solenoids
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    • A61B5/15125—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 a vacuum or compressed fluids
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    • A61B5/15188—Constructional features of reusable driving devices
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    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
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    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators

Abstract

刺血装置(10)，其中，在形成切口之前，电刺激应用到皮肤采样位点，以在位点实现疼痛掩盖和体液充盈中的至少一个。足够量的电刺激通过低电流高电压AC信号发生器(40)提供，以使血管舒张并且/或进行疼痛掩盖。

Description

用于进行电刺激以提高刺血装置性能的方法和设备
技术领域
本发明涉及用于从身体得到血液样品和其它流体以进行分析或处理的装置和方法。
背景技术
在本领域中，用于抽取体液样品以进行分析例如测定血糖水平的装置的广泛应用是卓有成效的，以解决若干问题和难题。存在的问题是，当皮肤被刺血针刺破的时候引起疼痛和确保足够量的血液在表面以得到适当的样品量。为了解决这些问题，提出了许多方案。
就疼痛控制而言，对刺血针本身的形状进行了开发。这些开发牵涉了切割的深度，从而使抽取样品所需要的深度最小化。另外，切口的比例受到控制，从而由于较快的切口而使疼痛减轻。
其它活动集中于通过使用振动器甚至通过分散患者注意力而对疼痛进行掩盖，从而使患者不会集中精力于在过程期间所经历的疼痛。
努力的第二方面集中于通过进行刺激而使血液增加，从而在刺血之后收集到至少最少的血液样品量，以准确地进行检验。一些研究集中于用手或通过多种机构对皮肤进行触摸以挤压出额外的血液。其他研究者提出使用振动、超声和其它刺激，以使血流增加。然而，这样的装置是过于粗糙和简陋的，或是过度复杂和昂贵的。
当采用替代位点检验(AST)以从除了手指之外的部位对体液进行采样的时候，以上活动日益受到关注。需要设法使疼痛最小化并且使血液充盈。
发明内容
在一种形式中，本发明涉及用于经过皮肤得到体液样品的装置。装置包括壳和在壳上的定位为接触在皮肤上的位点的电极。电信号发生器将足够量的电能应用到电极，以对在位点的皮肤进行刺激，以在位点实现疼痛掩盖和体液充盈中的至少一个。安装在壳内的皮肤刺血装置引导皮肤刺血介质在位点顶在皮肤上，以在应用电能之后，在其内形成切口。
在另一种形式中，本发明涉及经过皮肤得到体液样品的方法。方法包括将足够量的电能应用到在皮肤上的采样位点，以对在位点的皮肤进行刺激，以在位点实现疼痛掩盖和体液充盈中的至少一个。随后，切口形成在位点，以取出体液样品。
附图说明
图1显示了将本发明应用到刺血装置的示意图。
图2显示了用于在图1的刺血装置内使用的一套电极和皮肤接触端壁构型的透视图。
图3显示了用于图1的刺血装置的可选择的电极阵列和端壁设计。
图4显示了用于在图1中所示意显示的信号发生器的简化的电路图。
具体实施方式
为了有助于理解本发明的原理，现在对其中所图示的实施例进行参考，并且特定的语言用于描述实施例。然而，应该理解的是，不是意在对本发明的范围进行任何限制。对于在本发明所涉及的领域中的技术人员，对所描述的过程、系统或装置进行任何变更和更改和对其中所描述的本发明的原理进行任何其它应用被认为是意料之中的。
本发明对皮肤采样位点进行电处理，以在刺血装置形成用于对血液进行采样的切口之前，实现疼痛掩盖和血液充盈中的一个或两个。
参考图1，显示了包括形式可以为环状的壳12的刺血装置10。壳12具有皮肤接触端罩14，如在下面所讨论的那样，皮肤接触端罩14可以具有在图2或3中所显示的形式。端罩14具有可移开地连接到壳12的端部18的端部区段16。安装在壳12内的是连接到刺血针激励器22的刺血针保持件20。刺血针激励器22通过相互连接件26响应于操作者控制按钮24，以使刺血针载体22使刺血针28发生位移而到达在图1中所示的左侧，以刺破邻近装置10的皮肤。也可以的是，经过与刺血针激励器22的相互连接件(未显示)，使用顶在皮肤位点上的罩14的压力，以使刺血针28发生位移。刺血针激励器22适合于具有受到控制的位移和刺透深度的比例，以最适宜地提取体液例如血液。刺血针28是可移开的，从而使它可以在检验完成之后以适宜的方式处置。虽然描述了用于刺破皮肤的机械切入，但应该明显的是，用于切入的其它机制例如激光可以与本发明一起使用。
刺血针激励器22可以具有许多不同形式中的一种，以达到用于刺血针28的受到控制的位移和刺透深度的比例。刺血针激励器22可以具有使用弹簧状装置的机械形式。它也可以是电动激励的或气动激励的。如其中所显示的那样，毛细通道35从邻近刺血针28的切口的通道34的嘴通向通过光学读出器39给出体液参数或状态的指标的传感器37。可选择地，刺血针28可以刺破皮肤，从而使足够量的血液可以聚集在皮肤上，以应用到检验条上(未显示)。应该注意到的是，对于在本领域中的那些技术人员，单元可以用于收集经过刺血针28的血液样品，并且提供了整合检验过程的另一种途径。
可以看到的是，对于用于对血液进行采样以测量葡萄糖和进行其它应用的装置的范围，本发明的优点和特征是可同样应用的。更特定地，对于在单一的单元内对血液进行采样和分析的装置，本发明是可应用的。
根据本发明，刺血装置罩14具有多个集合在组内的电极30和32。电极30和32定位成围绕用于刺血针28的开口34的外围的阵列。如在下面所描述的那样，罩14可以具有在图2中或在图3中所显示的形式。电极组30和32可以以多种阵列配置在头上，以达到本发明的目的。它们可以以随机的方式定位，而在没有任何特定取向的情况下，对定位成彼此邻近。可选择地，对可以以圆周的方式围绕开口34排列。其它取向可以是径向阵列。基于现有实验，随机取向的电极可以达到本发明的目的。对于在本领域中的那些技术人员，应该明显的是，除了随机的方式之外，电极可以具有其它取向，并且仍然达到本发明的目的。
如在图1中所显示的那样，电极30和32通过线36和38连接到信号发生器和控制器40。信号发生器40经由线44和46用来自电源例如电池42的电能供给。如在图4中所显示的那样，信号发生器40包括具有输入导线72和74的集成电路(IC)振荡器70。振荡器70将在端子3上的输出经由电阻器76提供到晶体管78的门。晶体管78连接在到升压变压器80的输入上的线44和46之间。振荡器70的输出端子7提供了到达可变电阻器82的输入，从而对振荡器70的频率进行控制。变压器80的输出侧连接到通向电极30和32的输出导线36和38。电容器84和86提供了平稳的输出波。晶体管78发挥作用，使电流以近似方波经过变压器80的输入侧。在输出侧上，变压器80使电压输出增加为相等的方波。电容器86使波形平稳，从而使它结束为高电压AC波形。通过由操作者操纵的旋钮48，经由适宜的由虚线50指示的连接，可变电阻器82是可调整的。
如所图示的那样，信号发生器40是形成高电压AC波的类型。电压电平可以大概为从10到25千伏。频率优选地为20Hz。如对于在下面所描述的应用所适宜的那样，通过一定范围频率和电压，并且以低电流(即100毫安)，信号发生器控制器44可以适合于对信号发生器40进行控制。
本发明有赖于在刺血皮肤之前进行电处理的原理，以实现疼痛掩盖和体液或血液充盈中的至少一个。
在一个方面内，电脉冲刺激了在身体内的感觉神经元的外周末梢，其引起生物活性物质释放。这些物质大部分是神经肽、物质P和与降血钙素基因相关的肽。它们接下来作用于在所应用的区域的外围内的靶细胞例如掩盖细胞(masked cell)、免疫细胞和平滑肌产生炎症。这以变红、发热和血管舒张的指示为特征。这种现象已知为神经性炎症。
已经确定的是，持续时段大概为30秒的电刺激的应用可以使血管舒张。因此，在应用电能之后，剌血针28受到激励，以刺破皮肤，并且产生一定量的血液，通过对表面进行预处理以使血管舒张而使血液的量增加。在表1所概述的试验中，如所显示的那样，平均血液体积增加了77％，而得到75微升的样品的成功比例增加了16％。对于这个试验，电压水平为在20Hz的16千伏。对于在本领域中的那些技术人员，应该明显的是，在本说明书中所阐述的电参数只是基于当前的研究为了说明目的，而不是以任何对在本发明的范围内所应用的电参数的范围进行限制的方式进行诠释或解释。
                     表1
  试验       所收集的血液(μL)
  不进行刺激   进行刺激
  平均值(μL)中间值(μL)标准差在0.75μL的成功比例   0.820.910.5067％   1.451.360.6983％
通过使用在图2中所显示的挤压罩以允许在刺血之后对皮肤位点进行机械压缩，成功比例可以进一步提高。在皮肤接触面52上，罩14具有多个在围绕中心开口34的阵列内的电极对30和32，当刺血针28受到激励的时候，刺血针28延伸经过中心开口34。如在图2中所显示的那样，皮肤接触面52弯曲成负S形，而环状凹陷区段56从开口34通向环状凸出区段58。这种构型的目的是允许将皮肤接触面52应用到所刺血的皮肤位点，以迫使足够量的体液例如血液到达切口点，以得到用于血液分析的样品。
为了使用电刺激以掩盖疼痛，在对皮肤进行切入之前，电能持续地应用了较长的时间。这个电能可以通过在图1和2中所显示的相同的电极对使用，或它可以在图3的具有带有多个定位为大体上围绕用于刺血装置的中心开口66的电极对62和64的有平坦的面的皮肤接触罩60的装置内体现。头60连接到包含了在图1中以示意方式显示的元件的壳68。如在图1和2中所显示的那样，电极对62、64可以以随机、圆周或径向的方式进行取向。
使用任一种阵列，电极将电刺激递送到所要刺血的区域。基于其性质和特征，这种电刺激对感觉神经元进行刺激，感觉神经元对传入信息的信号传送到脊髓进行操纵。电刺激可以靶向于A-δ纤维和C-纤维，这耗尽了在纤维末端内的神经肽内容物，或可以靶向于A-β纤维，这使大量的信号释放。结果的类型基于电刺激的类型和强度例如所应用的刺激的脉冲率和持续时间。就对组织造成创伤或疼痛而言，这使神经元不能将信息传递到中枢神经系统。刺激也可以靶向于A-β纤维，这使大量的神经肽释放。A-β纤维与压力的检测相关联。当进行刺血的时候，通过A-β纤维和C-纤维传送的信号被大量的A-β纤维信号遮盖。这种现象趋向于减小神经性(neociceptive)疼痛的敏感性。由于个体的刺激阈值是不同的，所以为了确保适应尽可能多的使用者，装置是可对强度和脉冲率进行调整的。
表2显示了在进行电刺激的情况下和在不进行电刺激的情况下的疼痛等级。在进行刺血之前，电刺激在20Hz持续了至少60秒。在进行电刺激的情况下，减少了疼痛和/或增加了对疼痛的耐受力。对于在本领域中的那些技术人员，应该明显的是，在本说明书中所阐述的参数只是基于当前的研究为了说明目的，而不是以任何对在本发明的范围内所应用的电参数的范围进行限制的方式进行诠释或解释。
                           表2
    位点                   电刺激-疼痛等级
    参数   不进行电刺激   进行电刺激
    前臂手指   16千伏交流电，20Hz20千伏交流电，20Hz     12     02*
2*：疼痛强度为2但为更可耐受的疼痛
当装置意在用于疼痛掩盖和体液的充盈的时候，电刺激的应用持续大概60秒和更长。在30秒之后，血液在位点发生充盈，而在大概60秒之后，实现了疼痛掩盖。一旦实现了疼痛掩盖，刺血装置就受到激发，以刺血皮肤。在进行刺血之后，皮肤接触表面52可以用于从切口挤压体液或血液，以应用到检验条。可选择地，不同形式的抽取样品用于递送到另一个检验装置的刺血装置可以使用。
尽管就附图和在前面的描述对本发明进行了详细的说明和描述，但就特征而言，这些说明和描述应该被认为是说明性的而不是限制性的，应该理解的是，只显示和描述了优选的实施例，而所想要的是，在本发明的范围内的所有改变和更改都受到保护。

Claims (23)

1.用于经过皮肤得到体液样品的设备，所述的设备包括：
壳；
多个在所述的壳上并且定位为接触在皮肤上的位点的电极，
用于将电能应用到所述的电极的电信号发生器，所述的电信号发生器提供足够量的电能，以对在所述的位点的皮肤进行刺激，以在所述的位点实现疼痛掩盖和体液充盈中的至少一个；和
安装在所述的壳内的用于引导皮肤刺血介质在所述的位点顶在皮肤上以在应用所述的电能之后在其内形成切口的皮肤刺血装置。
2.根据权利要求1所述的设备，其特征在于，所述的电极定位成阵列，以围绕所述的位点。
3.根据权利要求2所述的设备，其特征在于，所述的皮肤刺血介质受到引导经过所述的电极阵列的中间进到所述的皮肤内。
4.根据权利要求1所述的设备，其特征在于，所述的电信号发生器提供高电压AC。
5.根据权利要求4所述的设备，其特征在于，与疼痛掩盖相比，用于充盈的电能的量是较少的。
6.根据权利要求5所述的设备，其特征在于，所述的电能应用到所述的位点持续大概30秒，以使体液充盈。
7.根据权利要求6所述的设备，其特征在于，对于疼痛掩盖和充盈，所述的电能供给源适合于使电能的应用持续至少一分钟。
8.根据权利要求4所述的设备，其特征在于，所述的电能供给源的电压范围为在低电流(即100毫安)下在大概10到25千伏之间。
9.根据权利要求2所述的设备，其特征在于，所述的单元具有在围绕所述的位点的阵列内的多个电极对。
10.根据权利要求1所述的设备，其特征在于，所述的设备是独立的单元。
11.根据权利要求10所述的设备，其特征在于，所述的电信号发生器具有可调整的电能水平。
12.根据权利要求1所述的设备，其特征在于，所述的电信号发生器适合于对电能水平进行调整。
13.根据权利要求1所述的设备，还包括邻近所述的皮肤刺血装置的用于指示体液参数的装置。
14.根据权利要求13所述的设备，还包括从皮肤切口通向所述的体液指示器装置的毛细通道。
15.一种用于经过皮肤得到体液样品的方法，所述的方法包括：
将足够量的电能应用到在所述的皮肤上的采样位点，以对在所述的位点的皮肤进行刺激，以在所述的位点实现疼痛掩盖和体液充盈中的至少一个；和
随后在所述的位点形成切口，以取出体液样品。
16.根据权利要求15所述的方法，其特征在于，所述的电能以围绕所述的位点的阵列应用。
17.根据权利要求15所述的方法，其特征在于，所述的电能以高电压AC的形式应用。
18.根据权利要求17所述的方法，其特征在于，较低水平的电能应用于充盈。
19.根据权利要求18所述的方法，其特征在于，应用于体液充盈的所述的电能持续大概30秒。
20.根据权利要求18所述的方法，其特征在于，应用于疼痛掩盖和充盈的所述的电能持续至少60秒。
21.根据权利要求17所述的方法，其特征在于，电压范围在大概15和25千伏之间。
22.根据权利要求17所述的方法，其特征在于，电能是可调整的。
23.根据权利要求15所述的方法，还包括以下步骤：在形成切口之后，对位点进行压缩，以进一步提高体液挤压。
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