CN102740772A - 具有单发执行器的分析物测量装置 - Google Patents
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Abstract
一种分析物检测设备,包括壳体、存取门和前端孔。模块可定位在壳体中。穿透构件设置在模块中,并且在激发时穿过前端孔。分析物传感器设置在模块中。穿透构件驱动器构造为连接到穿透构件。包括一种机构,其运动连接到穿透构件驱动器的臂进入激发位置,并且允许穿透构件驱动器的运动。
Description
技术领域
本发明涉及分析物测量装置,特别是涉及具有集成的传感器和穿透构件的一次性模块的分析物测量装置。
背景技术
激发装置在医学卫生保健产品工业上是已知的,其用于刺破皮肤而产生用于分析的血液。血样的生物化学分析是用于决定临床信息的诊断工具。多点保健试验采用全血执行,通常监测糖尿病人的血糖水平。该方法的其它用途包括氧分析和基于凝血素测量的凝结分析。典型地,用于这类分析的血滴通过在指尖上开很小的口而获得,产生很小的创伤,在皮肤的表面上产生很小的血滴。
早期的切缝方法包括用针或小刀在皮肤上穿刺或切片。当前的方法利用切缝装置,其包含很多弹簧、凸轮和众多的执行器来驱动刀片。这些包括悬挂弹簧、隔膜、线圈弹簧以及重力垂准器来驱动刀片。典型地,该装置是预搬起装置或使用者搬起装置。该装置保持抵靠皮肤或使用者,或者来自使用者皮肤的压力机械地激发小刀的弹道发射器。小刀的向前运动和皮肤穿透的深度由机械限位和/或阻尼以及弹簧或凸轮决定以缩回小刀。随着驱动器撞击发射器限位的端部,除了皮肤的振动刺激外,这样的装置由于反冲具有多次冲击的可能性,并且对皮肤厚度的变化仅允许粗略的控制。根据病人的感觉、血量和不同的切缝装置使用者获得血液的成功率,不同的皮肤厚度可能产生不同的结果。
成功率通常包含一次切缝动作产生血样的概率,使其在量上足以实现所希望的分析物试验。血液可自然地呈现在皮肤的表面,或者可从创伤“挤出”。挤出通常涉及压手指的侧面或者伤口附近以将血液呈现表面。通过切缝动作产生的血滴必须到达皮肤的表面以进行活性试验。对于一步切缝和血样获取的方法,自然的血滴形成是需要的。然后,能够结合试验条与切缝处理用于代谢物试验。
在采用现有技术的方法时,血液通常从切开的血管流出,然后在皮肤的表面下捕获,形成血肿。在其它的示例中,产生创伤,但是没有血从伤口流出。在任何情况下,切缝处理不能与样品采集和试验步骤结合。用当前机械发射系统的自然血滴形成变化在发射器的类型之间,但平均起来自然的小刀撞击约为50%。另外的需要挤出来产生血。如果每两次撞击之一不能产出自然的血样,则机械发射不可能提供集成样品和试验的装置。
很多糖尿病的病人(胰岛素依赖者)要求每天自身试验血糖水平五至六次。减少试验所需的步骤数会提高试验条件的适应性。试验条与切缝和样品生成结合的一步试验程序可实现简单的试验方式。改善适应性与糖尿病引起的并发症的长期处理直接相关,该并发症包括由血液中血糖水平大量变化引起的视网膜病、神经病、肾脏衰竭和周围血管退化。因此,通过频繁试验密切控制等离子体葡萄糖对于病人处理来说是强制性的。
必须采用切缝设备获得和分析血样的病人频繁遇到的另一个问题是适当操作切缝和样品试验设备所需的手动灵巧程度和手眼配合的程度,这是由于视网膜病和神经病,特别严重的是年长的糖尿病患者。对于这些病人,操作现有切缝和样品试验设备可能是个挑战。一旦产生血滴,则该血滴必须引入小试验条等的接收通道。如果条上的样品设置不成功,则整个程序的重复包括重新切开皮肤获得新的血滴是必要的。
所需要的是一种装置,其可可靠地、重复地和无痛地产生自然的血样。另外,需要在样品上执行分析物试验的方法,使其不要求很高程度的手动灵活性或手眼配合性。集成样品产生(切缝)与样品试验(样品到试验条)将产生简单的一步试验程序,其通过提高自试验状况的适应性而导致较好的疾病处理。
具有集成的传感器和穿透构件的模块的分析物测量装置存在需求。对于这样的分析物测量装置存在进一步的需求,其具有集成的传感器和穿透构件,由密封(箔)保护,以传感器保持无菌且维护干燥的环境。对于这样的分析物测量装置存在进一步的需求,其具有集成的传感器和穿透构件,由密封(箔)保护,以传感器保持无菌且维护干燥的环境,在密封后辐射消毒。对分析物测量装置存在另外的需求,具有集成的传感器和穿透构件,具有执行器单元,其接收一次性的模块且在加载序列期间穿破保护密封或箔。还存在对分析物测量装置的进一步需求,具有集成的传感器和穿透构件,具有执行器单元,其接收一次性的模块且在加载序列期间穿破保护密封或箔,具有在加载序列期间夹紧穿透构件的执行器。
发明内容
本发明的目标是提供具有集成的传感器和穿透构件的一次性模块的分析物测量装置。
本发明的另一个目标是提供一种分析物测量装置,具有集成的传感器和穿透构件,该装置由密封(箔)保护,以在传感器处保持无菌且维护干燥的环境。
本发明的再一个目标是提供一种分析物测量装置,具有集成的传感器和穿透构件,该装置由密封(箔)保护,以在密封后利用辐射消毒在传感器处保持无菌且维护干燥的环境。
本发明的进一步目标是提供一种分析物测量装置,具有集成的传感器和穿透构件,具有执行器单元,其在加载序列期间接收一次性的模块和刺破保护密封或箔。
本发明的另一个目标是提供一种分析物测量装置,具有集成的传感器和穿透构件,具有执行器单元,其在加载序列期间接收一次性的模块和刺破保护密封或箔,具有在加载序列期间夹紧穿透构件的执行器。
本发明的另一个目标是提供一种分析物测量装置,具有集成的传感器和穿透构件,具有执行器单元,其在加载序列期间接收一次性的模块和刺破保护密封或箔,具有在加载序列期间与分析物传感器建立电接触的执行器。
本发明的另一个目标是提供一种分析物测量装置,具有集成的传感器和穿透构件,具有执行器单元,其在加载序列期间接收一次性的模块和刺破保护密封或箔,具有在加载序列期间解锁安全清扫器的执行器。
本发明的另一个目标是提供一种分析物测量装置,具有集成的传感器和穿透构件,具有执行器单元,其在加载序列期间接收一次性的模块和刺破保护密封或箔,具有使用虚拟按钮的执行器单元以允许较大的显示器和更灵活的使用者界面。
本发明的这些和其它的目标实现在一种分析物检测设备中,该设备具有壳体、存取门和前端孔。模块可定位在壳体中。穿透构件设置在模块中且在激发时穿过前端孔。分析物传感器设置在模块中。穿透构件驱动器构造为连接到穿透构件。包括一种机构,其运动连接到穿透构件驱动器的臂进入发射位置且允许穿透构件驱动器的运动。
附图说明
图1示出了本发明的分析物检测设备的一个实施例,其中存取门开启且传感器模块插入准备加载的支架中。
图2示出了本发明的分析物检测设备的一个实施例,具有相对于壳体中模块的设置到位的密封。
图3示出了本发明的一个实施例,其中模块去除了箔以示出穿透构件和葡萄糖传感器的相对位置。
图4示出了在加载位置上没有密封具有一次性模块的穿透构件发射机构的实施例。
图5示出了具有收回的清洗手柄以及在检测后的本发明的实施例。
具体实施方式
在本发明的一个实施例中,提供一种机构,其利用包含了穿透构件和葡萄糖传感器(模块)二者的集成的一次性物件。在加载传感器模块时,使用者接近存取门,使手指压向前端孔,并且开始穿透构件激发序列。在该手指上产生很小的创伤,所产生的血液被葡萄糖传感器捕获且进行分析。所产生的血糖读数在显示器上呈现给使用者,显示器包括但不限于装置顶部上的LCD显示器。
在一个实施例中,一次性的葡萄糖传感器模块基于塑料注塑体,其支起穿透构件且保持葡萄糖传感器。作为非限定性示例,穿透构件和传感器可借助于铝箔保证无菌和湿度保护,铝箔连接到塑料体的顶部、端部和底部表面。图2示出了在适当位置上具有箔的模块。图3示出了去除箔的模块,并且示出了穿透构件和葡萄糖传感器的相对位置。
在本发明的一个实施例中,分析物检测设备10包括壳体12、存取门14和前端孔16。模块18可定位在壳体12中。穿透构件22设置在模块18中,并且在发射时穿过前端孔16。分析物传感器24设置在模块18中。穿透构件驱动器26,也就是发射机构,构造为连接到穿透构件22。包括这样的机构,其运动连接到构件驱动器26的臂进入发射位置,并且允许穿透构件驱动器运动。
如图1所示,所示的发射机构具有打开的存取门14以及插入其支架中以备加载的传感器模块18,还具有未示出的密封。在关闭存取门14时,内部杠杆运动清扫臂进入激发或发射位置,允许穿透构件驱动器26的自由运动。随着存取门14进一步关闭,模块18扫过切割刀片28,切割刀片28从模块18的端部去除保护密封30,并且暴露传感器端口和要使用的传感器电触头。
随着存取门14进一步关闭,迫使模块18在保护结构上,该保护结构刺破穿透构件22上的密封,并且折叠该密封远离穿透构件驱动器26。随着存取门14进一步关闭,模块18被压在连接到穿透构件驱动器26的夹具30上,迫使穿透构件22与夹具30配合。随着存取门14进一步关闭,复位弹簧32受压,并且最后限位开关34被激发,表明模块18完全就位,并且穿透构件22被夹紧且准备激发。当使用者释放存取门14时,复位弹簧32慢慢升起模块18,允许在促动序列期间夹具30的自由运动。
在图1中,手指按压的前端孔16、分析物传感器和穿透构件22可在单元的端部看见。该前端孔16是弹性的“前端”结构的一部分,“前端”结构使手指就位且促使产生自然产生的血。来自葡萄糖分析和执行器状态的结果显示在单元顶部上的显示器上。通过示出而不是限定,在一个实施例中,显示器36可为26.5mm×39.0mm LCD显示器。显示器36可构造为触摸屏,且也可用作“激发”按钮以及作为"深度增加"和"深度减小"按钮。
如图1所示,执行器按钮38或者条纹滑动手柄在壳体12的右前侧上可见。该按钮38连接到清扫臂40,并且当清扫臂40处于“激发”位置时凸出远离壳体12,提醒使用者穿透构件驱动器26可激发穿透构件22。在激发穿透构件22后,使用者仅需的动作是向后滑动执行器按钮38进入归位或“安全”位置。
在设备10的后续使用时,存取门14打开,并且使用过的模块18(如果存在)被去除,并且被没有使用过的一次性模块18所替换。然后,可关闭存取门14,重复循环。
作为非限定性示例,在一个实施例中,穿透构件驱动器26的尺寸约为58mm宽×75mm长×20mm厚(在显示器的位置)。作为非限定性示例,模块18的尺寸约为8.5mm宽×31mm长×3.75mm厚,并且一次性的传感器模块18的重量约为0.53gm。
如图4所示,示出了穿刺的一个实施例,在加载位置示出一穿透构件发射机构具有一次性的模块18而没有密封件。
图5示出了本发明在检测后且具有清扫手柄臂40的一个实施例。
根据本发明的目标和实施预期结果中期望的变化或差别。因此,旨在本发明由所附的权利要求的范围限定,并且这样的权利要求被宽泛地理解为在合理的范围内。
Claims (15)
1.一种分析物检测设备,包括:
壳体和存取门和前端孔;
模块,在该壳体中可定位;
穿透构件,设置在该模块中,并且在激发时穿过该前端孔;
分析物传感器,设置在该模块中;
穿透构件驱动器,构造为连接到该穿透构件;以及
机构,其运动连接到该穿透构件驱动器的臂进入激发位置,并且允许该穿透构件驱动器的运动。
2.如权利要求1所述的设备,其中手指在该前端孔上施加的压力开始该穿透构件的激发序列。
3.如权利要求1所述的设备,还包括:
显示器,设置在该壳体的外面以显示与分析物测量相关的读数。
4.如权利要求1所述的设备,其中该模块是塑料注塑体,其支撑该穿透构件且保持该分析物传感器。
5.如权利要求1所述的设备,还包括:
至少一个密封件,其保证无菌和湿度的至少其中之一。
6.如权利要求1所述的设备,还包括:
该模块顶部的第一密封件和该模块底部的第二密封件。
7.如权利要求1所述的设备,还包括:
清扫臂;以及
杠杆,连接到该清扫臂,以运动该清扫臂在激发位置。
8.如权利要求7所述的设备,其中在该激发位置上该清扫臂允许该穿透构件驱动器的自由运动。
9.如权利要求1所述的设备,还包括:
第一密封件打破装置,其中响应于该模块相对于该第一密封打破装置的运动,打开与该分析物传感器相关的密封件。
10.如权利要求9所述的设备,还包括:
第二密封件打破装置,其中响应于该模块的运动、响应于该存取门的关闭,该第二密封件打破装置打开与该穿透构件相关的密封件。
11.如权利要求1所述的设备,还包括:
穿透构件配合构件,其将该穿透构件配合到该穿透构件驱动器,响应于该存取门的关闭,该穿透构件成为与该穿透构件配合构件相配合。
12.如权利要求1所述的设备,还包括:
弹簧,随着该存取门的关闭而受压。
13.如权利要求12所述的设备,还包括:
开关,当该模块完全就位且该穿透构件夹紧且准备激发时给出指示。
14.如权利要求13所述的设备,其中当该存取门释放时,该弹簧升起该模块,并且允许该穿透构件配合构件在该穿透构件促动序列期间的自由运动。
15.如权利要求7所述的设备,还包括:
设在该壳体的外面的激活元件,其与该清扫臂配合。
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WO2011094116A1 (en) | 2011-08-04 |
ES2470192T3 (es) | 2014-06-23 |
AU2011209847A1 (en) | 2012-08-16 |
US8702624B2 (en) | 2014-04-22 |
US20100198108A1 (en) | 2010-08-05 |
US20140135599A1 (en) | 2014-05-15 |
JP2013517892A (ja) | 2013-05-20 |
AU2011209847B2 (en) | 2014-03-20 |
US9089294B2 (en) | 2015-07-28 |
HK1171933A1 (zh) | 2013-04-12 |
DK2528507T3 (da) | 2014-06-16 |
US20140135653A9 (en) | 2014-05-15 |
EP2528507A4 (en) | 2013-01-16 |
CA2787307A1 (en) | 2011-08-04 |
EP2528507B1 (en) | 2014-03-12 |
CN102740772B (zh) | 2015-09-02 |
EP2528507A1 (en) | 2012-12-05 |
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