CN1283972A - 带有穿刺附件的分析测量仪器 - Google Patents
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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
- A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
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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
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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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
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
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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
- A61B5/150007—Details
- A61B5/150763—Details with identification means
- A61B5/150778—Details with identification means having complementary physical shapes for indexing or registration purposes
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- 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
- A61B5/15101—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
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- 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
- A61B5/151—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
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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
- A61B5/1519—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
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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
- A61B5/150007—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
Abstract
本发明涉及一种用于测定血液中分析物的存在与否或其含量的设备,它包含有一个用于测量和显示测试元件的与此分析物相关的特有特性变化的测量仪器(1),以及一个用于从测试对象的一个身体部位上采取血样的穿刺附件(2),其特征在于,测量仪器(1)和穿刺附件(2)是直接地、可拆分开地相互连接在一起。本发明还涉及了这种设备的应用,以测定备注中分析物的存在与否或者含量。
Description
本发明涉及一种用于测定血液中一种分析物的存在与否或其含量的设备及其应用,这种设备包含有一个用于测量和显示测试元件的与此分析物相关的特有特征变化的测量仪器以及一个用于从测试对象的一个身体部位取血样的穿刺附件。
为确定血液中某些分析物(例如葡萄糖或乳酸盐)的含量要求采取充足的样品量(血),并且提供适合于这些分析物的测试设备。除了医生诊所和化验室外,更多的对医学不太了解的人对他们自身就采用这种测定方法。由测试对象本身应用的测试设备尤其广泛用于测定和检查糖尿病患者的血糖值,也即血葡萄糖含量。但也用于测定其它指标如乳酸盐含量或胆固醇水平。
传统的测试设备常常包含有测试元件,其形式为所谓的测试条,这种测试元件与相应的测试仪器一起就可以测定血液中的一种或多种分析物。此外使用者一般还需要有一个刺血针,用这种针就能在某个身体部位,例如在手指肚或耳垂上穿过皮肤并取得要用于测试的血样。为能舒适先进地取得血样,各厂家提供的穿刺附件都能检查并导引刺血针刺入皮肤,以便检查刺入深度并使疼痛最轻。
因为使用者为了测试血液中的一种分析物需要多个独立的部件(测试元件、测量仪器、穿刺附件、刺血针等),而且对于“室外”分析来说例如旅行或运动时都必须随身携带。因此首先是那些另外还必须随身携带胰岛素和注射器的糖尿病患者就认为减少随身携带的单件是很有必要的。
因此进行了各种不同的减少单件数量的努力。一种解决办法是将所需的部件如测量仪器、穿刺附件、刺血针和测试条都包装在一个共同的运输盒内。但这样体积就大了,而且例如放在茄克衫或衬衫的口袋里就太大太重了。
另一种解决办法是将尽可能多的上述单个部分集成一体于一个仪器内。测试条存放系统集成于一个测量仪器内,如US5,489,414或US5,645,798所描述的就是一个这样的实例。
举例来说,在US5,029,583和US4,637,403中所描述的就是将穿刺附件和测量仪器合并成一个仪器的设备。通过这种集成设备虽然大大解决了减少必须随身携带的单件数量问题,但这样的集成设备用于取血样时操作就不太方便,因为这种设备大多不便于使用,而且相对较重,因而就难于精确对准穿刺位置。
本发明的任务在于消除现有技术中的缺点。尤其寻找到一种将测量仪器和穿刺附件合成一体的设备,这种设备不仅要减少随身携带的单件的数量,同时可以精确地对准穿刺位置。
该任务就通过如在权利要求书中说明其特征的本发明内容来解决。
本发明内容是一种用于测定在血液中分析物的存在与否或其含量的设备,它包含有一个用于测量和指示测试元件的与此分析物相关的特有特征变化的测量仪器,以及一个用于从测试对象的一个身体部位取血样的穿刺附件,其特征在于,测量仪器和穿刺附件是直接地并且可拆开地相互连接在一起。
另外,本发明内容还有本发明设备的应用,即用于测定血液中分析物的存在与否或其含量。
最后,本发明内容还有本发明设备的单个组成部分,也就是说一个穿刺附件以及一个测量仪器,它们适合于直接地可拆开地相互连接。
本发明设备适合用于测定血液中分析物的存在与否及其含量。测定一种分析物的存在与否例如可以用于定性地诊断传染病(例如带有如丙肝病毒(HIV)或人体免疫缺陷病毒(HCV)这样的病毒),或者用于定性地了解某种身体状况(例如怀孕,心肌梗塞形成)。测定一种分析物的含量则可以用来检查一种疾病的进程或者一种治疗效果,而且详细指示出了患者的身体状况。这种实例就是测定血液中的血葡糖含量、乳酸盐或胆固醇浓度等。有利的是,可用本发明设备测定一种指标。在本发明设备的另一种实施形式中同样可以同时测定多种指标。
按照本发明,用设备中的测量仪器来测量和指示一种测试元件的与此分析物相关的特有特征的变化。测试元件可以是任意的、本身对专家已知的形式,例如测试条或者透明小容器等形式,最好在测试元件里(或元件上)含有对于指示反应所必要的试剂。借助于测试元件就可能在有一种或几种分析物时产生出一种可观察到的、作为测试元件特有的、与分析物相关的特征的信号。举例来说有指示试剂层的颜色变化,这种变化可用光度来测量,或者用电流;或者用电位的变化,对这种电位变化要用电极系统来探测。那么这样所产生的信号就由测量仪器来测量和分析处理,所用方法是例如将它们与校验值进行对比。根据所要检查的分析物可能有各种不同的指示原理和测定原理,这些原理一方面通过物理化学的指示原理(例如光度学、电化学),另一方面通过(生物)化学的相互作用而显示区别,这些原理就会引起特有的可观察到的变化(例如关于酶的或者免疫的反应,核酸序次指示)。
按本发明的设备除了有测量仪器外还有一个穿刺附件,用此附件可以抽取试验对象的血样。专业人员例如可从EP-B0565970中知道的穿刺附件,这些穿刺附件已由不同的经销商以各种不同的形式进行着商业推销。这种穿刺附件与刺血针组合一起用于舒适地、现代地、能再观地并且尽可能无痛地取得血样,例如以手指肚或耳垂上。
按照本发明,穿刺附件直接地并且可拆开地与测量仪器连接在所使用的设备系统里。所谓直接地连接应该是指,除了穿刺附件和测量仪器之外不再需要另外的分立的装置,例如袋、外壳、包带或小盒等用于连接穿刺附件和测量仪器了。更确切地说,测量仪器或者穿刺附件,或者这两个部分具有相应的、最好是相互协调并相互适配的连接装置,这种连接装置可使设备的两个部分实现可拆分的连接。可能的连接装置有插接连接、卡紧连接、通过成型轨道的连接和借助于磁铁或搭链扣的连接等。优先采用插接连接,尤其优先用借助于弹簧夹头的连接。
按本发明,在穿刺附件和测量仪器之间的连接,可以容易并快速地拆分开并可以重新连接起来,同时也就可以对本发明的设备进行方便的操作,这些都提高了使用者对此设备的接受程度。
因为对于本发明的一种优选实施例来说,无论是通过已拆分开的或者是与测量仪器连接状态的穿刺附件来取测试对象的血样应该同样是可能的,所以用一种稳定的,也就是说抵抗住在使用穿刺附件时在连接装置上产生的剪切力的连接则证明尤其有利。尤其优选的是借助于弹簧夹头的连接。弹簧夹头已知有各种不同的形式、材料和结构例如用于如自来水笔、圆珠笔或纤维笔的书写装置。
特别优先考虑使弹簧夹头装设在特别优选地具有如EP-B0565970所述基本上为圆柱状体、类似于圆珠笔形状的穿刺附件上,同时优先考虑具有基本为平坦的长方六面体形状的测量仪器具有一个相应形状的凹槽,尤其优选考虑设在其一个窄侧面上,这种凹槽可以准确适配地固定住此弹簧夹头并从而使穿刺附件和测量仪器实现稳定的、可拆分和直接的连接。优选的是弹簧夹头和用于固定住夹头的相应凹槽所采用的形状,应使使用者通过触觉或声音能觉察已经达到稳定的连接位置。通过把弹簧夹头结合在穿刺附件上和基本与此互补的测量仪器外壳上的凹槽就实现了两个按本发明的设备之间的明确、定向和导向的连接,而在穿刺附件和测量仪器之间的间隙则达到最佳,以便一方面形成一种稳定的抵抗住剪切力的连接,另一方面这种连接能够容易而快速地被拆分开。尤其优先考虑的是使穿刺附件通过与测量仪器的连接基本靠放在仪器的窄面上。
穿刺附件和测量仪器外壳的结构设计最好达到紧凑的整体形状。例如在测量仪器外壳上可以有一个凹坑状的空隙,这种空隙至少局部地围住这穿刺附件。除了这种装置的紧凑性之外由此也使穿刺附件和测量仪器之间的可拆分连接实现了一种附加的稳定性。
连接穿刺附件和测量仪器的弹簧夹头既可由穿刺附件或者说测量仪器的外壳材料,也可由一种其它的合适材料作成。这种合适的材料例如有金属、合金或者塑料,或者它们的组合,例如塑料覆层的金属或者金属化的塑料。弹簧夹头同时也可以是外壳的组成部分,例如制作为一个压铸件,或者一个单独的但与外壳牢固连接的组件。
同样证实为有利的是通过对测量仪器外壳的成型实现穿刺附件与测量仪器的连接。例如测量仪器在一个最好是一个窄的外壳面上具有挠性的夹紧爪,用此夹紧爪可以局部地围住穿刺附件,因而使穿刺附件可拆分地固定在测量仪器上。在这种情况下,可以放弃在穿刺附件上设置特有的用于固定于测量仪器上的装置。在该优选实施形式中,使穿刺附件和测量仪器实现可拆分连接的这种装置可以是测量仪器外壳的构成整体的组成部分,例如采用压注技术制造时就置入在其中。但也可以使所说的装置成型为单独的,但与外壳固定连接的部件。
通过按本发明的设备就向使用者提供了一种紧凑的穿刺附件-测量仪器设备,这种设备减少了单个部件的数量,而这些部件正是必须由使用者随身携带用于采血样并紧接着测量一个血液指标。此外十分有利的是,使用者可以任意地在与测量仪器连接一起的状态下使用该穿刺附件;或者也可以在与测量仪器拆分开的状态下使用该附件,因此使用者就有很大的灵活性。此外可使穿刺附件实现可靠、卫生的清洗,而不会存在损伤测量仪器的危险。
通过以下附图1-5对本发明进行详细说明。
图1是从上面看到的按本发明设备的一个优选实施形式的简明俯视图。
图2是图1所示的本发明设备的A方向的简明视图。
图3表示按图1本发明设备的穿刺附件和测量仪器之间的连接机构,见局部剖视简图。
图4借助三个局部图(A至C)构成了本发明的设备的一个图1至3中选择的优选实施形式。
图5同样是借助三个局部图(A至C)表示了本发明的设备的一个图1至4中选择的优选实施形式。
图中的符号意义为:
1.测量仪器
2.穿刺附件
3.显示器
4.测量仪器的操作元件
5.穿刺附件的操作元件
6.连接元件1(弹簧夹头)
7.连接元件2(互补凹槽)
8.测量仪器1的外壳壁
9.夹紧爪
如图1至图3所示,代表本发明的设备的一种特别优选的实施形式由一个测量仪器1和一个穿刺附件2构成,它们是直接地并可拆开地相互连在一起。此时穿刺附件2基本上侧靠于测量仪器1布置。
测量仪器1的尺寸设计应优先考虑可以在一个手中方便地握住。穿刺附件2基本为自来水笔型式,而且其大小(长度、直径)基本要与测量仪器1相匹配,从而在设备运输和操作中不存在突出或凸起的部件。
测量仪器1包含功能所必需的所有组成部分,其中在图1和图3中只是简要表示了显示器3以及操作元件4。要用测量仪器1测量的测试元件从图1的A侧被送入仪器1里,或者也可以从仪器1,例如从一个集成一体的测试元件库里提供使用。
穿刺附件2同样包含功能所必需的所有组成部分,其中仅简明表示了操作元件5。用于取血的刺血针从A侧被送入穿刺附件2里。
图3简明表示了连接件1(弹簧夹头)6和2(互补的凹槽)7的局部细节图,为此测量仪器上面的一部分揭去了。弹簧夹头6准确配合在由测量仪器1的壳体壁8所形成的互补的凹槽7里。
在使用穿刺附件2时使用者一般将附件从测量仪器1上拆分开,以便尽可能精确而无痛地进行采血样。为此必须将一个相应的刺血针装入穿刺附件2里,例如通过弹簧的张紧使穿刺附件2作好准备可以使用并紧接着放到应该抽取血样的所希望的身体部位上,例如手指肚或耳垂上。通过操作这操作元件5就使刺血针刺入所希望的身体部位,并抽取血样。
接着将血样置于最好已经位于测量仪器1里的测试元件的给样区上,其中至少是测试元件的这个给样区由测量仪器1上突出来。通过操作此操作元件4就开始了真正的测量。在测试元件上的指示反应结束时就在显示器上显示了分析物测定的测量值。
对于图4所示的由穿刺附件2和测量仪器1组成的本发明设备的其它优选实施形式来说这两个设备部分的可拆分连接同样是通过穿刺附件2上的弹簧夹头6和测量仪器1上相应的、互补的凹槽7来实现。凹槽7位于测试仪器外壳的一个侧壁里,该侧壁适配于穿刺部件的轮廓,以保证测量仪器1和穿刺附件2的连接稳定。
在图4A中借用俯视图表示出测量仪器1和穿刺附件2在相互连接状态下的情况。图4B是通过图4A中箭头标志出的平面所截取的测量仪器1和穿刺附件2的一个断面。在此断面图中可以很好地了解到测量仪器外壳的侧壁是如何适配在穿刺附件2的轮廓上的。
图4C表示了穿刺附件2是如何插卡在测量仪器1上的。穿刺附件2平行于测量仪器1,其弹簧夹头6指向外壳侧面,该外壳侧面具有与弹簧夹头6互补的凹槽7,而且通过弹簧夹头6导入凹槽7使穿刺附件与测量仪器1连接。弹簧夹头6、凹槽7和测量仪器1的侧壁对穿刺附件2的适配保证了连接稳固,但可重新拆分开。拆开这种连接的次序与制成这种连接的次序相反。
最后,图5表示了穿刺附件2和测量仪器1的另外一种可选择的连接机构。此时穿刺附件2没有专门的允许与测量仪器连接的装置。确切地说,这种连接是通过测量仪器1的一个侧面外壳壁的专门形状而促成的。该外壳壁具有夹紧爪9,在所示的优选实施形式中此夹紧爪9局部地围住了具有圆形横断面(图5B和C)的穿刺附件,并因此固定住,但可以方便地拆分开。夹紧爪9所用的材料一方面要求柔韧,以使其能被相互压开而固定住穿刺附件2,而另一方面要求刚挺,一旦当穿刺附件被夹紧爪9局部围包住并靠置在测量仪器1上时使穿刺附件2固定住。
图5A以俯视图表示了穿刺附件2是如何侧向靠紧测量仪器1并通过夹紧爪9而卡住在测量仪器1上。图5B是一个断面示意图,该断面是经过图5A中的测量仪器1和穿刺附件2的用箭头标记的平面。在此断面图中可以很好地了解到,作为测量仪器1外壳壁的组成部分的夹紧爪9是如何围包住穿刺附件2的。图5C如图5B都是穿刺附件2和测量仪器1的断面示意图,借助标记的箭头此处应指明,测量仪器外壳的夹紧爪9是如何在导入穿刺附件时相互张开移动的。
Claims (8)
1.用于测定血液中分析物的存在与否或其含量的设备,它包含有一个用于测量和指示一种测试元件的与此分析物相关的特有特性变化的测量仪器,以及一个用于从测试对象的一个身体部位上取血样的穿刺附件,其特征在于,测量仪器和穿刺附件是直接地而且可拆分开地相互连接在一起。
2.按权利要求1所述的设备,其特征在于,穿刺附件与测量仪器直接地并可拆分地经由一个弹簧夹头而连接起来。
3.按权利要求1或2所述的设备,其特征在于,穿刺附件基本上是侧面直接地并可拆开地与测量仪器连接起来。
4.按权利要求1至3中任一项所述的设备,其特征在于,无论在测量仪器上还是在穿刺附件上都具有可以使测量仪器和穿刺附件可拆开地、直接连接的装置。
5.按权利要求1至4中任一项所述的设备,其特征在于,借助于穿刺附件,无论是在与测量仪器连接的状态下还是从测量仪器上拆分开的状态下都可以从测试对象的一个身体部位上采取血样。
6.这样设计穿刺附件,使其可以与一个用于测量和指示测试元件的一种与此分析物相关的特有特性变化的测量仪器实现直接的、可拆分的连接。
7.这样设计测量仪器,使其可以与一个用于从测量对象的一个身体部位上采取血样的穿刺附件实现直接的、可拆分的连接。
8.按照权利要求1至5中任一项所述的设备的应用,其用于测定血液中分析物的存在与否或其含量。
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DE19752688 | 1997-11-28 | ||
DE19824036A DE19824036A1 (de) | 1997-11-28 | 1998-05-29 | Analytisches Meßgerät mit Stechhilfe |
DE19824036.8 | 1998-05-29 | ||
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- 1998-05-29 DE DE19824036A patent/DE19824036A1/de not_active Withdrawn
- 1998-11-30 ES ES98965713T patent/ES2285797T3/es not_active Expired - Lifetime
- 1998-11-30 DE DE59813993T patent/DE59813993D1/de not_active Expired - Lifetime
- 1998-11-30 AT AT98965713T patent/ATE361025T1/de active
- 1998-11-30 JP JP2000522846A patent/JP3569228B2/ja not_active Expired - Lifetime
- 1998-11-30 AU AU21556/99A patent/AU736568B2/en not_active Ceased
- 1998-11-30 PL PL98340720A patent/PL340720A1/xx unknown
- 1998-11-30 KR KR1020007005742A patent/KR20010032500A/ko not_active Application Discontinuation
- 1998-11-30 CN CN98813342A patent/CN1283972A/zh active Pending
- 1998-11-30 EP EP98965713A patent/EP1032307B1/de not_active Expired - Lifetime
- 1998-11-30 WO PCT/EP1998/007706 patent/WO1999027854A1/de active IP Right Grant
- 1998-11-30 CA CA002310378A patent/CA2310378A1/en not_active Abandoned
- 1998-11-30 HU HU0100071A patent/HUP0100071A3/hu unknown
- 1998-11-30 US US09/555,205 patent/US6379317B1/en not_active Expired - Lifetime
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CN1331440C (zh) * | 2002-05-09 | 2007-08-15 | 生命扫描有限公司 | 最少操作过程的分析物测试系统 |
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ES2285797T3 (es) | 2007-11-16 |
CA2310378A1 (en) | 1999-06-10 |
AU2155699A (en) | 1999-06-16 |
US6379317B1 (en) | 2002-04-30 |
EP1032307B1 (de) | 2007-05-02 |
DE59813993D1 (de) | 2007-06-14 |
JP3569228B2 (ja) | 2004-09-22 |
PL340720A1 (en) | 2001-02-26 |
AU736568B2 (en) | 2001-08-02 |
WO1999027854A1 (de) | 1999-06-10 |
HUP0100071A1 (hu) | 2001-05-28 |
KR20010032500A (ko) | 2001-04-25 |
JP2001524680A (ja) | 2001-12-04 |
HUP0100071A3 (en) | 2001-06-28 |
ATE361025T1 (de) | 2007-05-15 |
EP1032307A1 (de) | 2000-09-06 |
DE19824036A1 (de) | 1999-06-02 |
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