CN102639185B - 医疗装置插入物以及插入和使用医疗装置的方法 - Google Patents

医疗装置插入物以及插入和使用医疗装置的方法 Download PDF

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Publication number
CN102639185B
CN102639185B CN201180002616.7A CN201180002616A CN102639185B CN 102639185 B CN102639185 B CN 102639185B CN 201180002616 A CN201180002616 A CN 201180002616A CN 102639185 B CN102639185 B CN 102639185B
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China
Prior art keywords
insert
sensor
tip
upper shell
skin
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CN201180002616.7A
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CN102639185A (zh
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曼努埃尔·L·多纳伊
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Therasense Inc
Abbott Diabetes Care Inc
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Therasense Inc
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6865—Access ports
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    • A61B17/34—Trocars; Puncturing needles
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    • A61B5/14503—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 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
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    • A61B5/150511—Details of construction of shaft
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    • A61B5/15087—Communication to or from blood sampling device short range, e.g. between console and disposable
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    • A61B5/15107—Piercing being assisted by a triggering mechanism
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    • 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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    • 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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    • A61B5/15016—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
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Abstract

提供了一种将医疗装置插入对象皮肤中的设备、以及插入医疗装置的方法。

Description

医疗装置插入物以及插入和使用医疗装置的方法
相关申请的交叉引证 
本申请要求以下美国临时申请的权益：2010年3月24日提交的第61/317,243号美国临时申请；2010年5月17日提交的第61/345,562号美国临时申请；2010年7月2日提交的第61/361,374号美国临时申请；2010年11月8日提交的第61/411,262，这些文献的公开内容为了所有目的而以引证方式结合于此。 
通过引证结合 
为了所有目的而将这里描述的专利、申请和/或公开(包括以下专利、申请和/或公开)通过引证结合于此：美国专利号4,545,382；4,711,245；5,262,035；5,262,305；5,264,104；5,320,715；5,356,786；5,509,410；5,543,326；5,593,852；5,601,435；5,628,890；5,820,551；5,822,715；5,899,855；5,918,603；6,071,391；6,103,033；6,120,676；6,121,009；6,134,461；6,143,164；6,144,837；6,161,095；6,175,752；6,270,455；6,284,478；6,299,757；6,338,790；6,377,894；6,461,496；6,503,381；6,514,460；6,514,718；6,540,891；6,560,471；6,579,690；6,591,125；6,592,745；6,600,997；6,605,200；6,605,201；6,616,819；6,618,934；6,650,471；6,654,625；6,676,816；6,730,200；6,736,957；6,746,582；6,749,740；6,764,581；6,773,671；6,881,551；6,893,545；6,932,892；6,932,894；6,942,518；7,041,468；7,167,818；以及7,299,082；7,381,184；7,740,581；7,811,231；美国公开申请号2005/0182306；2006/0091006；2007/0056858；2007/0068807；2007/0095661；2007/0108048；2007/0149873；2007/0149875；2007/0199818；2007/0227911；2007/0233013；2008/0058625；2008/0064937； 2008/0066305；2008/0071157；2008/0071158；2008/0081977；2008/0102441；2008/0148873；2008/0161666；2008/0179187；2008/0267823；2008/0319295；2008/0319296；2009/0018425；2009/0247857；2009/0257911；2009/0281406；2009/0294277；2009/0054748；2009/0054749；2010/0030052；2010/0065441；2010/0081905；2010/0081909；2010/0213057；2010/0325868；2010/0326842；2010/0326843；2010/0331643；2011/0046466；美国专利申请序列号12/624,767；12/625,185；12/625,208；12/625,524；12/625,525；12/625,528；12/628,177；12/628,198；12/628,201；12/628,203；12/628,210；12/698,124；12/698,129；12/699,653；12/699,844；12/714,439；12/730,193；12/794,721；12/807,278；12/842,013；12/870,818；12/871,901；12/873,301；12/873,302；13/011,897；以及美国临时申请号61/238,646；61/246,825；61/247,516；61/249,535；61/317,243；61/325,155；61/345,562和61/359,265。 
背景技术
检测和/或监测某些个体的葡萄糖水平或其它分析物，比如乳酸、氧、AIC等对其健康是至关重要的。例如，监测葡萄糖对糖尿病患者来说尤其重要。糖尿病患者通常通过监测葡萄糖水平来确定葡萄糖水平是否维持在临床安全范围内，同样还利用该信息来确定是否需要胰岛素来降低体内的葡萄糖水平和/或确定什么时候需要胰岛素来降低体内的葡萄糖水平或者什么时候需要额外的葡萄糖来提高体内的葡萄糖水平。 
增加的临床数据表明葡萄糖监测和葡萄糖控制的频率之间有很大的关联。尽管存在上述关联，但由于便利性、测试判定、葡萄糖检测造成的疼痛及成本等一系列因素，许多经诊断患有糖尿情况的患者仍然不能经常监测葡萄糖水平。 
已开发了装置用于自动监测分析物，比如血液或间质液(“ISF”)等体液中或其他生物体液中的葡萄糖。一些分析物测量装置构造成使得将至 少一部分装置放置在使用者皮肤表面的下面，例如使用者的血管或皮下组织中，以便在体内完成监测。 
随着分析物监测装置和系统的不断开发，需要低成本、方便且能减少疼痛、提供谨慎监测以支持频繁地监测分析物以提高葡萄糖控制水平的分析物监测装置、系统及方法、以及制作该分析物监测装置和系统的工艺。 
发明内容
提供了一种用于将医疗装置至少部分地插入对象的皮肤的设备，其包括第一子组件和第二子组件。第一子组件包括：限定用于放在对象皮肤上的远端表面的护套、可在近端位置和远端位置之间移动的手柄、用于支撑医疗装置并限定通过其中的孔的装置支撑部(装置支撑部与手柄接合)、用于支撑延伸穿过所述孔的尖端并与装置支撑部接合的尖端支撑部、以及用于朝着近端位置偏压尖端支撑部的第一驱动器。第二子组件包括：被构造为可移除地附接至第一子组件的壳体、以及用于使尖端支撑部朝着远端位置前进的第二驱动器。 
在一些实施方式中，第一子组件和第二子组件是模块化元件。在一些实施方式中，第一子组件能够与第二子组件独立地操作。在一些实施方式中，第一子组件的驱动器能够由用户在不使用第二子组件的情况下操作。在一些实施方式中，可通过按下致动开关或按钮来致动第一子组件的驱动器。在一些实施方式中，将第二子组件构造为启动第一子组件的启动开关或按钮。 
在一些实施方式中，第二驱动器包括可旋转的凸轮或扭簧。在一些实施方式中，第二驱动器包括轴向驱动器和曲柄组件或压缩弹簧。在一些实施方式中，第一驱动器包括压缩弹簧或扭簧。 
在一些实施方式中，手柄至少部分地设置在护套周围。在一些实施方式中，提供用于将装置支撑部保持在远端位置的保持件。可将装置支撑部与手柄接合，直到装置支撑部到达远端位置为止。 
在一些实施方式中，将第一子组件构造为用于单次使用。在一些实施方式中，将第二子组件构造为用于多次使用。 
提供了分析物传感器的实施方式，其包括具有近端部分和远端部分的本体。远端部分可与近端部分纵向地对准。可在近端和远端部分之间包括中间部分，并且，在一些实施方式中，将中间部分至少从远端构件横向地移动。 
在一些实施方式中，将近端容纳在针座内以产生锚定区域，从而允许传感器本体滑入限定于插入尖端中的开口中，但是防止传感器本体从插入针意外地滑出。在一些实施方式中，将传感器本体的远端部分的宽度的尺寸构造为安装在插入尖端的开口内。在某些实施方式中，尖端中的开口具有大约20至大约26口径的直径，例如21口径(gauage)至大约25口径，其中，在某些实施方式中，尖端是21口径或23口径或25口径。这种尖端可与具有大约0.20mm至大约0.80mm(例如大约0.25mm至大约0.60mm)的宽度或直径的传感器(至少由尖端承载的部分具有这样的宽度或直径)一起使用，其中，在一些实施方式中，传感器的至少一部分的宽度或直径是0.27mm或0.33mm或0.58mm。 
在一些实施方式中，中间件包括改变平面的部分。改变平面的部分允许传感器本体的近端部分位于与传感器本体的远端部分不同的平面中。在一些实施方式中，近端部分和远端部分在基本上垂直于彼此的平面中，例如该区域可定义大约120°至大约60°的角度，例如大约90°。 
在某些实施方式中，提供用于将医疗装置至少部分地插入对象的皮肤的设备，其包括：限定用于放在对象的皮肤上的远端表面的护套；可在近 端位置和远端位置之间移动的手柄；用于支撑医疗装置并限定通过其中的孔的装置支撑部，装置支撑部与手柄接合；用于支撑延伸穿过所述孔的尖端并与装置支撑部接合的尖端支撑部；以及用于朝着近端位置偏压尖端支撑部的驱动器。 
在一些实施方式中，驱动器包括压缩弹簧。在一些实施方式中，将手柄至少部分地设置在护套周围。在一些实施方式中，包括用于将装置支撑部保持在远端位置的挡块部分。在一些实施方式中，将装置支撑部与手柄接合，直到装置支撑部到达远端位置为止。在一些实施方式中，当装置支撑部到达远端位置时，装置支撑部与尖端支撑部分离。 
在一些实施方式中，第二组件与插入装置或第一子组件连接。第二组件使所述插入物自动地进行插入部分运动。第二组件可包括：被构造为可移除地附接至第一子组件的壳体；被构造为相对于壳体纵向地运动的手柄；被构造为相对于壳体纵向地运动的致动器；位于致动器或手柄上的释放构件，其在手柄到达预定位置后启动；可在手柄和致动器之间接合的驱动器元件，在手柄的远端运动后被供以能量(energized)，一旦致动释放构件，手柄在远端驱动致动器；以及也在手柄的远端运动后被供以能量的第二驱动器，其在手柄上施加近端力，在从手柄后插入减小压力之后该近端力使手柄返回至近端位置。通过手柄接合的第二驱动器也提供近端力，以使致动器返回至重新接合释放构件的其近端位置。 
在一些实施方式中，第一驱动器包括压缩弹簧或扭簧。在一些实施方式中，将手柄至少部分地设置在护套周围。在一些实施方式中，提供用于将装置支撑部保持在远端位置的保持件。可将装置支撑部与手柄接合，直到装置支撑部到达远端位置为止。 
在一些实施方式中，将第一子组件构造为用于单次使用。在一些实施方式中，将第一子组件构造为用于多次使用。在一些实施方式中，将第二子组件构造为用于多次使用。 
对于本领域的技术人员来说，在阅读如下更充分地描述的详细说明的基础上，所公开的主题的这些和其他特征、目的和优点将变得显而易见。 
附图说明
参考以下简要描述的附图，提供了这里描述的主题的各种方面、特征和实施方式的详细描述。这些附图是示意性的而并不必成比例地画出，为了清楚起见，放大了部分部件和特征。附图示出了本主题的各种方面和特征，并可能整体或部分地示出本主题的一个或更多个实施方式或实例。 
图1示出了一些实施方式中的用于实时分析物(例如葡萄糖)测量、数据采集和/或处理的分析物监测系统； 
图2至图3是根据所公开的主题的另一实施方式的电化学传感器的视图； 
图4至图5是根据所公开的主题的一个实施方式的针插座(needle hub)的示意图。 
图6是根据所公开的主题的一个实施方式的尖端的远端视图； 
图7是根据所公开的主题的一个实施方式的尖端的侧视图； 
图8是根据所公开的主题的一个实施方式的尖端的侧视图； 
图9是根据所公开的主题的一个实施方式的插入物的分开部分的透视图； 
图10是用于形成将在根据所公开的主题的一个实施方式的插入物中使用的尖端的替代实施方式的示意图； 
图11是根据所公开的主题的一个实施方式的插入物的透视图； 
图12是根据所公开的主题的一个实施方式的插入物的分开部分的透视图； 
图13是根据所公开的主题的一个实施方式的插入物的分开部分的放大截面图； 
图14是根据所公开的主题的插入物的另一实施方式的透视图； 
图15是根据所公开的主题的图14的插入物的侧视图； 
图16至图17是根据所公开的主题的图14的插入物的横截面图； 
图18至图19是根据所公开主题的另一实施方式的插入物的透视图； 
图20至图21是根据所公开主题的图18的实施方式的插入物与另一实施方式的图14的插入物结合的透视图； 
图22至图24是根据所公开主题的图18的实施方式的插入物与另一实施方式的图14的插入物结合的侧视图； 
图25至图26是根据所公开主题的另一实施方式的插入物的透视图； 
图27至图28是根据所公开主题的图25的实施方式的插入物与另一实施方式的图14的插入物结合的透视图； 
图29至图31是根据所公开主题的图25的实施方式的插入物与另一实施方式的图14的插入物结合的侧视图； 
图32是根据所公开主题的另一实施方式的插入物的侧视图； 
图33是根据所公开主题的另一实施方式的插入物的透视图； 
图34至图43是示出了插入物致动过程的图32至图33的插入物的视图； 
图44是根据所公开主题的另一插入物的横截面图； 
图45是根据所公开主题的图44的插入物的分解透视图； 
图46至图53是示出了根据所公开主题的多种元件的装配的图44的插入物的透视图； 
图54至图58是根据所公开主题的图44的插入物的横截面图； 
图59示出了利用根据所公开的主题的图44的消毒形式的插入物的方法； 
图60示出了利用根据所公开主题的图44的消毒形式的插入物的替代方法； 
图61是根据所公开主题的另一插入物的透视图； 
图62至图66是根据所公开主题的图61的插入物的横截面图； 
图67至图69是根据所公开主题的图61的插入物的元件的透视图； 
图70是根据所公开主题的插入物的透视图； 
图71是根据所公开主题的图70的插入物的分开部分的透视图； 
图72至图79是根据所公开主题的图70的插入物的横截面图。 
具体实施方式
这里提供了本公开的详细描述。应理解，结合以下描述，该主题并非限于所描述的特定实施方式，因为该主题的特定实施方式当然可以改变。还将理解，这里使用的术语仅是为了描述特定实施方式的目的，并非意在是限制性的，因为所公开的主题的范围将仅由所附权利要求限制。 
在提供一定范围的值的地方，可理解，该范围的上限和下限之间的插入值、以及该所述范围中的任何其他所述的或插入的值均包含在所公开的主题内。每个所述范围还意在特别地公开所述范围的每个“子范围”。也就是说，还将每个比由对一个范围(其上限和下限在从外部下限到外部上限的范围内(除非上下文清楚地表明不是这样))给定的外部上限和外部下限的值指定的外部范围小的范围理解成包含在所公开的主题内，服从任何特定排除的范围或所述范围内的限制。在通过指定上限和下限中的一者或两者来规定范围的情况下，排除那些所述极限中的任一者或两者的或包括极限中的一者或两者的范围也包含在所公开的主题内，不管在描述范围时是否使用诸如“从”、“到”、“通过”或“包括”的词语。 
除非另有规定，本文使用的所有科技词汇具有本发明所属领域的普通技术人员通常所了解的相同含义。尽管任何类似于或等同于本文所述的方法及材料也可用于对本公开的主题进行实践或测试，但现在只对优选方法及材料进行阐述。 
除非另外说明，否则为了所有目的通过引证结合于此的在本公开中提到的所有公开物包括但不限于公开和描述这些公开物所提到的方法和/或材料。 
仅为了其在本申请的申请日之前的公开而提供这里讨论的公开物。不应将这里的任何公开物理解成不允许在这种公开物之前由于在先发明而授权本公开的主题。此外，所提供的公开日可能与实际的公开日不同，此实际的公开日可能需要单独确认。 
如这里使用的和在所附权利要求中使用的，单数形式“一”、“该”、“所述”包括复数对象，除非上下文明确表示不是这样。 
不应将摘要或发明内容中包含的任何部分理解成限制公开范围。为了著录和方便的目的而提供摘要和发明内容，由于其格式和目的的原因，不应将其认为是全面的。 
如本领域的技术人员将在阅读此公开内容的基础上理解的，这里描述并示出的各个实施方式中的每一个均具有不连续的部件和特征，在不背离本公开的主题的范围或实质的前提下，可容易将其与任何其他几个实施方式的特征分离或组合。可以所述事件的顺序、或以逻辑上可能的任何其他顺序执行任何所述方法。 
对单个物品的参考包括存在多个相同物品的可能性。当用替代性的“或”提到两个或更多个物品(例如，元件或方法)时，这表示，任一个可分开地存在，或者其任何组合可一起存在，除了必须排除另外一个或更多个存在的情况。 
通常，本公开的实施方式涉及用于将医疗装置至少部分地插入患者的皮肤中的设备。一些实施方式涉及检测体液中的至少一种分析物(例如葡萄糖)的体内方法和装置。因此，实施方式包括体内分析物传感器，其被构造为使得将传感器的至少一部分定位在用户体内(例如ISF内)，以获得关于身体的至少一种分析物的信息，例如经皮定位在用户的身体中。在某些实施方式中，将体内分析物传感器与保持在用户身体上的电子装置单元接合，以处理从传感器获得的信息。 
在某些实施方式中，将分析物信息从第一装置(例如体上电子装置单元)传递至第二装置(其可能包括用户界面特征，包括显示器等)。当可获得分析物信息时，可将信息从第一装置自动地和/或连续地传递至第二装置，或者可以不自动地和/或连续地传递，而是储存或记录在第一装置的存 储器中。因此，在系统的许多实施方式中，仅当用户询问时，以用户可用的或看得见的形式获得由传感器/体上电子装置(例如体上电子装置)得到的分析物信息，从而使得用户选择数据通信的定时。在一些实施方式中，在没有数据通信的定时时，用户选择显示信息。 
这样，在一些实施方式中，仅当用户需要时，向用户提供分析物信息，该信息对用户来说是明显的(设置在用户界面装置上)，即使体内分析物传感器自动和/或连续监测体内分析物水平，即传感器在其使用寿命期间按照预定时间间隔自动监测分析物(如血糖)。例如，在指定的检测时间段内(如约14天)将分析物传感器进行体内定位并耦连至体上电子装置。在某些实施例中，将传感器产生的分析物信息自动从传感器电子组件传输至远程监测装置或显示装置，以便根据体上电子装置设定的时间表(例如约每1分钟、约每5分钟或约每10分钟等)在14天内输出至用户。在某些实施例中，传感器产生的分析物信息在用户规定的时间(例如当用户决定检查分析物信息的任何时间)只从传感器电子组件传输至远程监测装置或显示装置。此时，激活通信系统，并然后将传感器产生的信息从体上电子装置发送至远程装置或显示装置。 
在其他实施例中，当分析物信息可用时，可将信息自动和/或连续地从第一装置传输至第二装置，并且第二装置存储或记录接收的信息而不向用户呈现或输出该信息。在此类实施例中，当信息可用时(例如，当传感器根据时间表检测分析物水平时)，通过第二装置从第一装置接收该信息。然而，接收的信息最初存储在第二装置中，并且在检测到对第二装置上的信息的请求时，只输出给第二装置的用户界面或输出装置(如显示器)。 
相应地，在某些实施例中，一旦本文所述的插入物用来将传感器电子组件件放置到身体上，使得体内传感器的至少一部分与体液(如ISF)接触。一旦传感器与电子部件电耦连时，可以通过给显示装置通电(或连续供电)并执行存储在并取自显示装置的存储器的软件算法将传感器产生的分析物信息从体上电子装置传输至所需显示装置，生成一个或更多个请求 命令，控制信号或数据包发送至体上电子装置。显示装置的微处理器或专用集成电路(ASIC)的控制下执行的软件算法包括检测体上电子装置相对于显示装置的位置的程序，以促使传输生成的请求命令、控制信号和/或数据包。 
显示装置可还包括存储在存储器中由一个或更多个微处理器和/或ASIC执行的程序，以响应于用户激活显示装置上的输入机构(如按下显示装置上的按钮、触发数据通信功能相关的软按钮等)，生成一个或更多个请求命令、控制信号或数据包，并传输以发送至体上电子装置。将输入机构可替换地或额外地设置在构造成用于用户激活的体上电子装置上或之中。在某些实施例中，语音命令或音频信号可用于促使或指示微处理器或ASIC执行存储在存储器中的软件程序，以生成一个或更多个请求命令、控制信号或数据包并传输至体内装置。在语音激活或响应于语音命令或音频信号的实施例中，体上电子装置和/或显示装置包括麦克风、扬声器及存储在体上电子装置和/或显示装置的各个存储器中用来处理语音命令或音频信号的处理程序。在某些实施例中，将体内装置和显示装置相对于彼此定位于预定距离(例如接近距离)内启动了一个或更多个存储在显示装置的存储器中的软件程序，以生成并传输请求命令、控制信号或数据包。 
可发送不同类型和/或形式和/或数量的信息以满足每个所需阅读，阅读需求包括但不限于以下的一个或更多个：当前分析物水平信息(即时间上与启动阅读的时间相对应的实时或最近获得的分析物水平信息)、预定时间段内的分析物的变化率、分析物变化率的速率(变化率加速度)、与在指定阅读之前获得并存储在组件的存储器中的分析物信息相对应的历史分析物信息。可以将实时、历史、变化率、变化率速率(如加速度或减速度)信息中的一些或全部发送至显示装置，供指定阅读。在某些实施例中，发送至显示装置的信息的类型和/或形式和/或数量可以是被预编程和/或不可更改的(如在制造过程中预设)，或可以不是被预编程和/或不可更改的，以便在本领域可选择和/或可更改一次或多次(如通过激活系统的开关等)。相应地，在某些实施例中，针对每个所需阅读，显示装置将输出 当前(实时)传感器产生的分析物数值(如以数字格式)、当前分析物变化率(如以分析物速率指示物的形式，比如指向指示当前速率的方向的箭头)、以及基于由体上电子装置的存储器获取并存储于其中的传感器读数的分析物走势历史数据(如，以图形轨迹形式)。另外，将与每个所需阅读相关的皮肤上或传感器上的温度读数或测量值从体上电子装置传输至显示装置。但是，温度读数或测量值可能不输出或显示在显示装置上，而可以结合由显示装置执行的软件程序使用以便纠正或补偿在显示装置上向用户输出的分析物测量值。 
如上所述，实施例包括体内分析物传感器和体上电子装置，体内分析物传感器和体上电子装置一起提供躯体可佩戴式传感器电子组件。在某些实施例中，体内分析物传感器与体上电子装置完全接合为一体(制造期间固定连接)，然而在其他实施例中，体内分析物传感器与体上电子装置在制造后是独立但可连接的(例如，在传感器插入身体之前、插入过程中或插入之后)。体上电子装置可包括容纳(除了用于体内定位的传感器部分之外)在包括粘附垫或可附接至粘附垫的防水外壳中的体内葡萄糖传感器、电子装置、电池及天线。在某些实施例中，该外壳能承受浸在水下一米处高达至少30分钟。在某些实施例中，该外壳能承受连续水下接触例如超过约30分钟，并根据其预期使用继续正常运转，而例如在外壳适用于水浸没的情况下不会对外壳电子装置造成水损坏。 
实施例包括传感器插入装置，其还可被称为传感器传送单元等。插入装置可将体上电子装置组件完全保持在内隔室中，即，插入装置在制造过程期间可预装有体上电子装置组件(例如，可将体上电子装置封装在插入装置的无菌内隔室中)。在此类实施例中，插入装置可形成用于预先使用的传感器组件封装件(包括无菌封装件)或新的体上电子装置组件、和构造为将体上电子装置组件应用于患者身体的插入装置。 
实施例包括便携式手持显示装置，便携式手持显示装置作为与体上电子装置组件间隔开的独立装置，从组件收集信息并为用户提供传感器产生 的分析物读数。这种装置还可被称为计量器、读取器、监测器、接收器、人机接口装置、成对部件等。某些实施例可包括一体的体外分析物计量器。在某些实施例中，显示装置包括一个或更多个有线或无线通信端口，如USB、串行端口、并行端口等，构造为建立显示装置与另一单元(如体上电子装置、给电池再充电的供电单元、PC等)之间的通信。例如，显示装置的通信端口可以能够利用各自的充电电缆对显示装置电池充电和/或在显示装置与其兼容信息软件之间进行数据交换。 
某些实施例中的兼容信息软件包括但不限于例如在显示装置、个人计算机、服务器终端上存在或在其上运行的独立或网络连接使能的(enabled)数据管理软件程序，例如以便进行数据分析、制作图表、数据存储、数据存档和数据通信以及数据同步化。某些实施例中的信息软件还可包括这样的软件，该软件用于执行可现场升级功能对显示装置和/或体上电子部件的硬件进行升级以便对显示装置和/或体上电子部件上存在的软件进行升级，而例如包括其他部件和/或包括软件缺陷或误差的硬件版本是固定的等等。实施例可包括触觉反馈部件(如振动马达等)，其构造使得可以触觉反馈的形式传递相应的通知(例如，显示装置接收的成功所需读数)。 
实施例包括嵌入计算机可读介质上的程序，即基于计算机的应用软件(本文中还可被称为信息软件或程序等)，其具有从系统获得的分析物信息和/或用户自报数据。通过显示装置或体上电子部件将应用软件安装到主机，例如手机、PC、诸如网络电话的互联网使能的人机接口装置、个人数字助理等。信息程序可以转换在显示装置上或体内单元上获得的并存储的数据，以供用户使用。 
仅为了方便起见，主要针对葡萄糖监测装置和系统、及葡萄糖监测方法描述了本公开的实施例，并且该描述并不用来限制本发明的范围。应理解，分析物监测系统可构造为在相同时间或不同时间监测各种分析物。 
详细描述如下，实施例包括在预定监测时间段监测一个或更多个生理参数的装置、系统、试剂盒和/或方法，参数诸如为但不限于分析物水平、温度水平、心率、用户活动水平。还提供了制造方法。预定监测时间段可以小于约1小时，或者可包括约1小时以上，例如约几小时以上、例如约几天以上、例如约3天以上、例如约5天以上、例如约7天以上、例如约10天以上、例如约14天以上、例如约几个星期、例如约1个月以上。在某些实施例中，预定监测时间段到期后，系统的一个或更多个部件可自动在体上电子装置组件和/或显示装置中停用或禁用。 
例如，预定监测时间段可始于将传感器定位于体内并与体液(诸如ISF)接触，和/或始于体上电子装置的启动(或通电为完全运作模式)。体上电子装置的初始化可通过由以下之一生成并传输的命令来实现：通过显示装置响应于开关的激活、和/或通过将显示装置放置到距体上电子装置在预定距离(如接近距离)内、或通过用户手动激活体上电子单元上的开关(例如按下按钮)，或者这些激活可以由插入装置产生，例如正如2010年2月1日提交的第12/698,129号美国专利申请、及第61/238,646、61/246,825、61/247,516、61/249,535、61/317,243、61/345,562及61/361,374号美国临时申请所述，这些文献中的每一个的公开内容均通过引证结合于本文用于所有目的。 
当响应于接收的来自显示装置的命令进行初始化时，体上电子装置从其存储器获取并执行软件程序以便充分对体上电子装置的部件进行通电，响应于从显示装置接收激活命令而有效地将体上电子装置置于完全运作模式。例如，在接收到来自显示装置的命令之前，通过内部电源(诸如电池)对体上电子装置中的一部分部件供电，而体上电子装置中的另一部分部件处于掉电或低功率(包括无功率)停用模式，或者所有部件都处于停用模式、掉电模式。当接收命令时，将体上电子装置部件的剩余部分或所有部分切换为主动全运行模式。 
体上电子装置的实施例可包括具有包括在ASIC、微处理器、存储器等中执行的控制逻辑的电子装置的一个或更多个印刷电路板、以及形成单一组件的经皮定位的分析物传感器。当在一个预定的接近一时间段(例如约2分钟、例如小于约1分钟、例如小于约30秒、例如小于约10秒、例如小于约5秒、例如小于约2秒)内检测分析物监测系统的显示装置时、和/或直到在显示装置上输出确认(诸如声音和/或视频和/或触觉(振动))通知以指示成功从体上电子装置获取分析物相关信号时，体上电子装置可构造为提供与监测到的分析物水平相关的一个或更多个信号或数据包。在某些实施例中，对于失败的采集，还可以输出不同的通知。 
在某些实施例中，监测到的分析物水平可以与血液或其他液体(如ISF)中的葡萄糖水平相关联和/或转换为葡萄糖水平。可利用体上电子装置来完成这种转换，但在许多实施例中，这种转换通过显示装置电子装置来完成。在某些实施例中，葡萄糖水平来源于ISF中监测的分析物水平。 
分析物传感器可以是可插入于静脉、动脉或身体的包含分析物的其他部分。在某些实施例中，分析物传感器可定位成与ISF接触以检测分析物水平，其中检测到的分析物水平可用于推断用户血液或间质组织中的葡萄糖水平。 
实施例包括经皮传感器以及可整体植入式传感器和可整体植入式组件，其中将包括分析物传感器的单一组件和电子装置设置在密封外壳(例如，密封的生物相容性外壳)中，以便植入用户体内用于监测一个或更多个生理参数。 
实施方式包括设置于小的、重量轻的、电池供电的和用电控制的系统中的分析物监测器。可将这种系统构造为，用电化学传感器检测对象的物理参数(例如表示体内分析物水平的信号)，并通过或不通过处理来收集这种信号。可用任何适当的测量技术从传感器获得信号，例如，可检测电流，可使用电位法等。这些技术可包括，但不限于电流分析法、电量分析 法和伏安法。在一些实施方式中，传感系统可以是光学的、比色的，等等。在一些实施方式中，可将执行此初始处理的系统的部分构造为对另一单元提供原数据或至少初始处理的数据，以进一步收集和/或处理。例如，可通过有线连接(例如电连接)，或用无线连接(例如IR或RF连接)来提供这种数据。 
在某些系统中，分析物传感器与体上电子装置通信。体上单元可包括体上电子装置和传感器的至少一部分容纳于其中的壳体。 
某些实施方式是模块化的。可将体上单元单独提供为在物理上与监测器单元不同的组件，例如，其对用户显示或以其他方式表示分析物水平。可将体上单元构造为，在通信链路上对监测器单元提供由传感器检测的分析物水平和/或其他信息(例如温度、传感器使用寿命等)。在一些实施方式中，监测器单元可包括例如移动电话装置、体内葡萄糖测量计、个人数字助理，或其他消费者电子装置(例如MP3装置、照相机、收音机、个人电脑等)，或其他使得能够通信的数据处理装置。 
显示器单元可执行各种功能，例如但不限于对所接收的分析物数据的数据存储和/或处理和/或分析和/或通信等，以产生与所监测的分析物水平相关的信息和/或处理其他信息。监测器单元可包含显示屏(其例如可用来显示所测量的分析物水平)、和/或以用声音对用户提供信息的音频部件(例如扬声器)、和/或对用户提供触觉反馈的振动装置。对于分析物监测系统的用户来说，能够看到趋势指示(包括任何正在进行的趋势的大小和方向，例如分析物的变化率或其他参数、以及对象高于和/或低于阈值(例如低葡萄糖和/高葡萄糖阈值)的时间量等)也是有用的；可用数字和/或用可视指示器显示这种数据，例如可改变可视属性的箭头，例如大小、形状、颜色、行为或方向。监测器单元可进一步适于从体内分析物测试条或者在体内分析物测试条附近接收信息，所述测试条可手动地或自动地进入监测器单元。在一些实施方式中，监测器单元可包含体内分析物测试条端口和相 关的电子装置，以能够用体内测试条进行不连续的(例如血糖)测量(例如见6,175,752，其公开内容为了所有目的而通过引证结合于此)。 
在可将一个或更多个部件可构造为单次使用和可将一个或更多个部件可构造为可重复使用的情况下，这些系统的模块性可改变。在一些实施方式中，将传感器设计为能够与体上电子装置附接和从体上电子装置拆离(并且体上单元可以是可重复使用的)，例如，使得部件中的一个或更多个可重复使用一次或多次，而在其他实施方式中，可将传感器和体上电子装置提供为一体的、不可拆离的封装，可将其设计为在使用后是抛弃的，即是不可重复使用的。 
体内监测系统的实施方式 
为了说明而不是限制的目的，这里描述的插入物可与图1所述的示例性分析物监测系统一起使用。应理解，这里描述的插入物可自己地或与系统接合地与任何医疗装置一起使用。图1示出了根据本公开实施方式的示例性的基于体内的分析物监测系统100。如所示出的，在某些实施方式中，分析物监测系统100包括与体内分析物传感器14电接合的体上电子装置1100(其近端部分在图1中示出，并附接至粘附层218以用于附接在用户身体上的皮肤表面上)。体上电子装置1100包括限定内部隔室的体上壳体122。 
图1中还示出了插入装置200(或这里描述的插入装置300、400、2400、2500、2700、3700)，当操作时，入装置将分析物传感器14的一部分穿过皮肤表面经皮定位并与ISF流体接触，并将体上电子装置1100和粘附层218定位在皮肤表面上，如将在这里更详细地描述的。在某些实施方式中，在使用前将体上电子装置1100、分析物传感器14和粘附层218密封在插入装置200的壳体内，并且，在某些实施方式中，也将粘附层218密封在壳体内，或者粘附层能够提供密封以保持设备的无菌状态。例如，在美国专利申请号12/698,129和美国临时申请号61/238,646、61/246,825、 61/247,516、61/249,535和61/345,562中讨论了与插入装置相关的其他细节，每篇申请的公开内容为了所有目的通过引证而结合于此。 
返回参照上图1，分析物监测系统100包括：显示装置1200，该显示装置包括向用户输出信息的显示器1220；输入部件1210，诸如按钮、致动器，触敏开关、电容式开关、压敏开关、缓动盘(jog wheel)等，以向显示装置1200输入数据或命令或者控制显示装置1200的操作。值得注意的是，某些实施例可包括不含显示器的装置或没有用户界面部件的装置。这些装置可作为数据记录装置来用于存储数据和/或提供一根管道将数据从体上电子装置和/或不含显示器的装置传输至另一装置和/或位置。本文将阐述用作示例性目的的显示装置的实施例，其并不限制本发明的实施例。显而易见的是同样可以在某些实施例中使用不含显示器的装置。 
在某些实施例中，体上电子装置1100构造为在监测时间段内将一些或所有接收自分析物传感器14的监测分析物相关数据存储在存储器中，并保持在存储器中直至使用期结束。在此类实施例中，在监测时间段结束时，例如，在通过从皮肤表面拆下在监测时间段内定位的体上电子装置1100而将分析物传感器14从用户身上拆下来之后，从体上电子装置1100获取存储的数据。在此类数据记录构造中，实时监测到的分析物水平在监测时间段内不传输至显示装置1200，或者以其它方式从体上电子装置1100传输而来，而是在监测时间段之后从体上电子装置1100获取。 
在某些实施例中，显示装置1200的输入部件1210可包括麦克风，并且显示装置1200可包括构造为分析接收自麦克风的音频输入的软件，因此显示装置1200的功能和操作可由语音命令控制。在某些实施例中，显示装置1200的输出部件包括用于输出作为音频信号的信息的扬声器。为体上电子装置1100设置类似的语音响应部件，诸如扬声器、麦克风、及用于生成、处理和存储语音驱动信号的软件程序。 
在某些实施例中，显示器1220和输入部件1210可集成到单一部件中，例如能够检测在显示器(如触摸屏用户界面)上的身体接触触摸的存在和位置的显示器。在此类实施例中，用户可通过使用一组预编程运动命令来控制显示装置1200的操作，包括但不限于单击或双击显示器、在显示器上拖动手指或仪器、朝彼此移动多个手指或仪器、将远离彼此移动多个手指或仪器等。在某些实施例中，显示器包括具有像素区的触摸屏，像素区具有用作LCD部件和触摸传感器的单一功能或双功能电容部件。 
显示装置1200还包括与诸如远程终端(个人计算机)1700等外部装置进行有线数据通信的数据通信端口1230。数据通信端口1230的实例包括构造为连接至可兼容数据电缆的USB端口、迷你USB端口、RS-232端口、以太网端口、火线端口或其类似数据通信端口。显示装置1200还可包括整体式体外葡萄糖仪，葡萄糖仪包括接收用于体外葡萄糖测量的体外葡萄糖试纸的体外试纸端口1240。 
仍然参照图1，某些实施例中的显示器1220被构造为显示多种信息，即，部分或全部信息可在同一时间或不同时间显示在显示器1220上。在某些实施例中，显示的信息是用户可选择的，以便用户能够自定义显示在指定显示屏上的信息。显示器1220可包括但不限于例如在监测时间段内提供葡萄糖值图形输出的图形显示器1380(其可显示诸如饮食、运动、睡眠、心率、血压等重要指标)、例如提供监测的葡萄糖值(该葡萄糖值是响应于信息请求获取或接收的)的数字显示器1320、以及例如通过移动显示器1220上的位置来指示分析物变化率和/或分析物变化率速率的走势或方向箭头显示器1310。 
图1还示出，显示器1220还可包括例如为用户提供日期信息的日期显示器1350、为用户提供当日时间信息的当日时间信息显示器1390、以图形方式显示显示装置1200的电池状况(充电式或抛弃式)的电池电量指示显示器1330、例如在需要定期、常规或预定数量的用户校准事件的监测系统中通知用户有必要进行分析物传感器校准的传感器校准状态图标 显示器1340、用于显示音频/振动输出或报警状态的音频/振动设置图标显示器1360、以及提供与诸如体上电子装置、数据处理模块1600和/或远程终端1700的其他装置进行无线通信连接指示的无线连接状态图标显示器1370。如图1另外示出的，显示器1220可进一步包括用于访问菜单、改变显示图形输出构造或用于控制显示装置1200操作的模拟触摸屏按钮1250、1260。 
返回参照图1，在某些实施例中，显示装置1200的显示器1220(其附加于视觉显示器、或者替代视觉显示器)可构造为输出诸如报警和/或警报通知、葡萄糖值等的警告通知，警告通知可以是听得见的、可感触的或即听得见又可感触的。在一方面，显示装置1200可包括其他输出部件(如扬声器、振动输出部件等)，以便除显示器1220上提供的可视输出指示外还为用户提供可听见的和/或振动的输出指示。在例如美国专利申请号12/871,901、美国临时申请号61/238,672，61/247,541，61/297,625中可获取进一步详情及其他显示器实施例，这些文献中的每一个的公开内容通过引用结合于本文用于所有目的。 
在将体上电子装置1100定位于皮肤表面上并将分析物传感器14定位于体内与ISF(或其他合适体液)建立流体接触后，某些实施例中的体上电子装置1100构造为当体上电子装置1100从显示装置1200接收命令或请求信号时无线传输分析物相关数据(诸发，例如与监测到的分析物水平相对应的数据和/或监测到的温度数据、和/或存储的历史分析物相关数据)。在某些实施例中，体上电子装置1100可构造为至少定期传播与监测到的分析物水平相关的实时数据，当显示装置1200在体上电子装置1100传播的数据的通信范围内时，该数据由显示装置1200接收，即不需要来自显示装置的命令或请求来发送信息。 
例如，显示装置1200可构造为向体上电子装置1100发送一个或更多个命令以启动数据传输，并且作为响应，体上电子装置1100可构造为将在监测时间段内收集的存储分析物相关数据无线发送至显示装置1200。显 示装置1200进而可连接至远程终端1700(诸如个人计算机)，并用作数据管道以将存储分析物水平信息从体上电子装置1100传输至远程终端1700。在某些实施例中，从体上电子装置1100接收的数据可存储在显示装置1200的一个或更多个存储器中(永久或暂时地)。在某些其他实施例中，显示装置1200被构造为数据管道，以将接收自体上电子装置1100的数据传递至与显示装置1200连接的远程终端1700。 
仍然参照图1，还示出了分析物监测系统1000中具有数据处理模块1600和远程终端1700。远程终端1700可包括个人计算机、服务器终端、笔记本电脑或其它合适的包括用于数据管理和分析并与分析物监测系统1000中的部件进行通信的软件的数据处理装置。例如，远程终端1700可与局域网(LAN)、广域网(WAN)、或其它数据网络连接，以便于在远程终端1700和显示装置1200和/或数据处理模块1600之间进行单向或双向数据通信。 
某些实施例中的远程终端1700可包括医生办公室或医院的一个或更多个计算机终端。例如，远程终端1700可位于除显示装置1200位置以外的位置。远程终端1700和显示装置1200可位于不同房间或不同建筑物内。远程终端1700和显示装置1200可至少间隔约一英里，例如至少间隔约100英里、例如至少间隔约1000英里。例如，远程终端1700可与显示装置1200在同一个城市中，远程终端1700可与显示装置1200在不同城市中，远程终端1700可与显示装置1200在同一个州(省)中，远程终端1700可与显示装置1200在不同州(省)中，远程终端1700可与显示装置1200在同一个国家中，或者例如远程终端1700可与显示装置1200在不同国家中。 
在某些实施例中，诸如数据处理模块1600的独立可选数据传输/处理装置可设置在分析物监测系统1000中。数据处理模块1600可包括利用一个或更多个无线通信协议进行通信的部件，无线通信协议例如但不限于红外线(IR)协议、蓝牙协议、Zigbee协议及802.11无线LAN协议。包括基于蓝牙协议和/或Zigbee协议描述的通信协议的附加描述可在美国专利 申请公开号2006/0193375中找到，该申请通过引用结合于本文用于所有目的。数据处理模块1600可进一步包括通信端口、驱动器或连接器，以与显示装置1200、体上电子装置1100、或远程终端1700中的一者或多者建立有线通信连接，所述通信端口、驱动器或连接器包括但不限于USB连接器和/或USB端口、以太网连接器和/或端口、火线连接器和/或端口、或RS-232端口和/或连接器。 
在某些实施例中，数据处理模块1600被编程为按预定时间间隔(如每分钟一次、每五分钟一次等)将轮询或查询信号发送至体上电子装置1100，并作出回应从体上电子装置1100接收监测到的分析物水平信息。数据处理模块1600将接收到的分析物水平信息存储在其存储器中，和/或将接收到的信息传送或转发至另一个装置(如显示装置1200)。更具体地说，在某些实施例中，数据处理模块1600可构造为数据传送装置，以将接收到的分析物水平数据从体上电子装置1100转发或传递至显示装置1200或远程终端(例如通过数据网络，诸如蜂窝或WiFi数据网络)或转发或传递至显示装置1200和远程终端两者。 
在某些实施例中，体上电子装置1100和数据处理模块1600可在彼此的预定距离(例如，约1-12英寸、或约1-10英寸、或约1-7英寸、或约1-5英寸)内定位于用户的皮肤表面上，从而维持体上电子装置1100与数据处理模块1600之间的定期通信连接。可替换地，数据处理模块1600可佩戴在用户的皮带或衣物上，从而维持体上电子装置1100与数据处理模块1600之间进行通信的所需距离，以便进行数据通信。在另一方面，数据处理模块1600的外壳可构造为与体上电子装置1100耦连或接合，从而使得两个装置组合或整合为单一组件并设置皮肤表面上。在其他实施例中，数据处理模块1600可拆卸地接合或连接至提供附加模块化的体上电子装置1100，使得数据处理模块1600根据需要可选地拆除或重新附接。 
再次参照图1，在某些实施例中，数据处理模块1600被编程为按预定时间间隔(诸如每分钟一次、或每5分钟一次或每30分钟一次)或任 何其他合适的或期望的可编程时间间隔向体上电子装置1100发送命令或信号，以向体上电子装置1100请求分析物相关数据。在收到请求的分析物相关数据时，数据处理模块1600保存所接收到的数据。这样，分析物监测系统1000可构造为按编程或可编程时间间隔接收连续监测到的分析物相关信息，该信息被存储和/或向用户显示。随后，可向显示装置1200、远程终端1700等提供或发送数据处理模块1600中存储的数据，以便于随后进行数据分析(诸如识别在监测时间段内葡萄糖水平偏移期间的频率、或者监测时间段内警告事件发生的频率)，例如以便改善与治疗相关的决策。利用该信息，医生、医护人员或用户可对饮食、日常生活习惯和日常例行事务(如运动)等进行调整或进行修改。 
在另一实施例中，数据处理模块1600向体上电子装置1100发送命令或信号，以便响应于用户激活设置于数据处理模块1600上的开关或响应于接收自显示装置1200的用户发起命令而接收分析物相关数据。在其他实施例中，数据处理模块1600构造为仅在预定时间间隔过去之后响应于接收用户发起命令而向体上电子装置1100发送命令或信号。例如，在某些实施例中，如果用户在编程时间段(如从上次通信约5小时(或从上次通信10小时、或从上次通信24小时))内不发起通信，则数据处理模块1600可被编程为自动向体上电子装置1100发送请求命令或信号。可替换地，数据处理模块1600可被编程为发起警告，以通知用户自上次数据处理模块1600与体上电子装置1100之间的通信以来预定时间时间段已结束。这样，用户或医护人员可对数据处理模块1600进行编程或构造以便提供对分析物监测方案的一定程度的服从，从而由用户维持或进行分析物水平的频率测定。 
在某些实施例中，当检测编程或可编程警告条件时(例如，由分析物传感器14监测到的不在预定可接受的范围内的检测葡萄糖水平，其表示医疗或分析需要注意或干预的生理状态(例如低葡萄糖条件、高葡萄糖条件、即将发生的低葡萄糖条件、或即将发生的高葡萄糖条件))，一个或更多个输出指示可由体上电子装置1100的控制逻辑或处理器生成并在体上 电子装置1100的用户界面上输出给用户，从而可及时采取纠正措施。另外地或可替换地，如果显示装置1200在通信范围内，则将输出指示或警告数据传输至显示装置1200，在检测到收到警告数据时，显示装置的处理器控制显示器1220输出一个或更多个通知。 
在某些实施例中，体上电子装置1100的控制逻辑或微处理器包括基于从分析物传感器14获取的信息(例如当前分析物水平、分析物水平变化率、分析物水平变化加速度、和/或基于存储的监测到的分析物数据确定的且用于在监测时间段内根据时间提供分析物水平波动的历史走势或方向的分析物走势信息)来确定未来或预期分析物水平的软件程序。预测警告参数可以在显示装置1200中、或在体上电子装置1100中或在两者中被编程或可编程，并在预见用户的分析物水平达到未来水平前向用户输出。为用户提供了及时采取纠正措施的机会。 
信息(比如在提供分析物走势信息的监测时间段内根据时间发生的监测分析物水平的变化或波动)可由显示装置1200、数据处理模块1600、和/或远程终端1700、和/或体上电子装置1100中的一个或更多个控制逻辑或微处理器确定。这种信息可以作为例如图表(诸如线条图)显示，以向用户指示由分析物监测系统1000测量的和预测的当前和/或历史和/或预测将来的分析物水平。这种信息还可显示为方向箭头(例如，见走势或方向箭头显示器1310)或其他图标，例如其在屏幕上相对于指示分析物水平是否增加或降低以及分析物水平增加或降低的加速度或减速度的参考点的位置。用户可利用该信息确定任何必要的纠正措施，以确保分析物水平保持在可接受的和/或临床安全范围内。其他视觉指示器(包括颜色、闪光、褪色等)、以及音频指示器(包括音高变化、音量变化、或音频输出和/或振动音调变化)或其他触觉指示器可结合于走势数据的显示器中，以便通知用户监测到的分析物水平的当前水平和/或方向和/或变化率。例如，基于确定的葡萄糖变化率、编程的临床意义的葡萄糖阈值水平(例如，高葡萄糖水平和/或低葡萄糖水平)、以及由体内分析物传感器产生的当前分析物水平，系统1000可包括存储在计算机可读介质上的算法，以用来确定 达到临床意义水平所花费的时间和在读取临床意义水平之前(例如在预见临床意义水平之前30分钟、和/或20分钟、和/或10分钟、和/或5分钟、和/或3分钟、和/或1分钟等)输出通知的时间，且输出的强度等增加。 
再次参照上图1，在某些实施例中，由数据处理模块1600执行的软件算法存储在外部存储器装置中，外部存储器装置诸如SD卡、微SD卡、紧凑闪存卡、XD卡、Memory Stick卡、Memory Stick Duo卡、或USB记忆棒/装置，这些装置包括存储在此类装置中的可执行程序，以便在连接至体上电子装置1100、远程终端1700或显示装置1200中的相应一个或更多个时执行。在另一方面，可为通信装置(诸如手机，例如包括WiFi或互联网使能的智能手机或个人数字助理(PDA))提供由数据处理模块1600执行的软件算法，作为用于由下载通信装置执行的可下载应用程序。 
智能手机的实例包括基于 AndroidTM、 操作系统、 WebOSTM、 操作系统、或 操作系统的手机，其具有数据网络连接功能以便通过因特网连接和/或局域网(LAN)进行数据通信。如上所述，PDA包括例如便携式电子装置，其包括一个或更多个微处理器及与用户界面(例如显示/输出单元和/或输入单元)进行数据通信的能力，并被构造为用于执行数据处理，例如，在互联网上传/下载数据。在此类实施例中，当建立远程终端1700与上述通信装置中的一个或更多个装置之间的通信时，远程终端1700可构造为向所述装置提供可执行应用软件。 
在又一实施例中，可执行软件程序可设置于无线(OTA)作为OTA下载，从而无需与远程终端1700的有线连接。例如，可执行程序可作为软件下载自动下载到通信装置，并根据通信装置的构造安装在装置上供自动使用，或基于用户确认或认可而安装在通信装置上以执行应用程序的安装。软件的OTA下载和安装可包括更新或升级到数据处理模块1600和/或显示装置1200的现有功能或特征的软件应用和/或程序。 
返回参照图1的远程终端1700，在某些实施例中，当建立远程终端1700和显示装置1200和/或数据处理模块1600之间的通信时，为显示装置1200和/或体上电子装置1100和/或数据处理模块1600的新软件和/或软件升级(诸如软件补丁或修复、固件升级或软件驱动程序升级等)可由远程终端1700提供。例如，对体上电子装置1100的软件升级、可执行程序变更或修改可由显示装置1200或数据处理模块1600中的一个或更多个从远程终端1700接收，然后提供到体上电子装置1100以对其软件或可编程功能进行升级。例如，在某些实施例中，体上电子装置1100中接收和安装的软件可包括软件缺陷修复程序、对先前停滞软件参数的修改(对分析物相关数据存储时间间隔的修改、重置或调整体上电子装置1100的时间基准或信息、对传输数据类型、数据传输序列、或数据存储时间段的修改等)。美国申请号12/698,124、12/794,721、12/699,653及12/699,844、以及美国临时申请号61,359,265及61/325,155中提供了描述便携式电子装置的软件的领域可升级性及数据处理的其他详细情况，这些文献的公开内容通过引用结合于本文用于所有目的。 
传感器 
分析物测量系统100的分析物传感器14可用来监测多种分析物的水平。可被监测的分析物包括例如乙酰胆碱、淀粉酶、胆红素、胆固醇、绒毛膜促性腺素、肌酸激酶(例如CK-MB)、肌酸、DNA、果糖胺、葡萄糖、谷氨酰胺、生长激素、激素、酮、乳酸、氧、过氧化物、前列腺特异性抗原、凝血酶原、RNA、促甲状腺激素、及肌钙蛋白。还可监测药物(诸如例如抗生素(如庆大霉素、万古霉素等)、洋地黄毒苷、地高辛)的浓度、滥用药物、茶碱及华法林。可用给定的传感器监测一种或多种分析物。在这些监测一种以上分析物的实施例中，可以在相同时间或不同时间通过单个传感器或通过使用(例如，同时地使用)相同体上电子装置的多个传感器或通过不同体上电子装置监测分析物。 
在本公开的一个实施方式中，将传感器14物理地定位在监测其分析物水平的用户的身体之中或之上。可将传感器14构造为连续地采样用户的分析物水平并将所采样的分析物水平(例如葡萄糖浓度)转换成相应的数据信号(例如电流或电压)，以输入于体上电子装置中。可替换地，可将传感器14构造为根据需要采样分析物水平。体上电子装置可放大、过滤、平均和/或以其他方式处理由传感器所提供的信号。 
在图2中示出了传感器14的一个实施方式。应理解，这里描述的插入物可与其他医疗装置一起使用。这里描述的形状仅是说明性的。考虑其他传感器形状。在一些实施方式中，传感器14包括介电的基板，例如聚合物或塑料材料，诸如聚酯或聚酰胺。在此实施方式中，将传感器构造为使得一部分定位在皮肤下方并且一部分定位在皮肤上方。因此，传感器14包括插入部或内部部分30和外部或电接触部分32。在一些实施方式中，接触部分32包括多个用于与其他电子装置连接的导电触点36、38和40(这里示出了三个触点)，例如位于体上电子装置1100处(见图1)。在此实施方式中提供的触点用于工作电极、参考电极和对电极。在一些实施方式中，提供两个或更多个工作电极。这些电极的操作部分(即工作电极、参考电极和对电极(未单独示出))设置于插入部分处，例如位于插入部分30的远端处，例如位于部分34处。在一些实施方式中，一个或更多个电极可在身体之外，例如外部的对电极。通过在基板表面上延伸的电路道(circuit trace)42、44和46将触点和电极的操作部分连接。在一些实施方式中，电路道设置于通道中，或可埋入基板内，或可横过基板的不同侧面。用导电材料制造导电触点、导电道和电极，例如铂、钯、金、碳等。不止一种材料可用于给定传感器。例如，在美国专利号6,175,572和6,103,033中描述了传感器的其他细节，这些专利为了所有目的通过引证而结合于此。 
传感器14可包括近端保持部分48。将插入部分30和近端保持部分48的尺寸和结构构造为，用尖端定位以安装在对象的皮肤中，如这里描述 的。在使用中，可将传感器14构造为弯曲(例如沿着线B)，并由此定位在两个基本上垂直的相交平面中。这种弯曲可出现在与体上电子装置的接合之前或接合过程中，如下面描述的(见图17)。 
部分48和52在传感器的近端和远端部分之间提供电连接路径，例如导电道。传感器14进一步设置有凹口或切口54。这种结构利于弯曲传感器14(例如沿着由线B表示的线)使得保持部分48保持直立并由此定位在两个基本上垂直的相交平面中，如图3所示。如将在下面描述的，可将传感器拉片(tab)50装在体上壳体122中，以帮助固定并定位传感器14。近端保持部分48保持其与插入部分30的纵向对准，用于定位在插入尖端内。 
这里已经描述了分析物传感器的实施方式，以便通过应用有化学感测层的电极的布置来电化学地操作，通过产生与分析物的氧化还原反应的体积(以及分析物浓度的指示)成比例的电流，由特定分析物氧化酶催化。存在这样的实施方式：被提供为产生并检测这些反应的水平的电极数量是两个、三个或更多个。然而，如这里描述的，可使用其他类型的传感器。 
传感器14的一部分可位于皮肤表面的上方，其中远端部分30穿透皮肤并进入与用户生物流体(例如ISF)接触的皮下空间。在美国专利号5,264,104；5,356,786；5,262,035；5,320,725和6,990,366中提供了与传感器14的电化学相关的进一步细节，每篇专利为了所有目的通过引证而结合于此。 
在一些实施方式中，可在使用期内(例如一分钟或更长时间、至少一天或更长时间、大约1至大约30天或甚至更长、大约3至大约14天、大约3至大约7天，或在一些实施方式中，高达几周的更长的时间段)将传感器植入对象体内，以接触并监测存在于生物流体中的分析物。在这点上，可将传感器设置在对象体内的各种位置(例如腹部、上臂、大腿等)，包括设置在肌肉中，经皮设置、设置在血管内，或设置在体腔中。 
在一些实施方式中，在一段使用期中通过插入和/或植入用户体内来使用传感器14。在这种实施方式中，可用相对柔性的材料制造基板。 
虽然图2至图3所示的实施方式具有三个电极，但是其他实施方式可包括更少或更多数量的电极。例如，可利用双电极传感器。传感器14可以是外部供电的并允许电流通过，所述电流与存在的分析物的量成比例。可替换地，传感器14本身在一些实施方式中可用作电流源。在一些双电极实施方式中，传感器可以是自偏压的，可能不需要参考电极。在2009年2月26日提交的名称为“自供电分析物传感器”的美国专利申请序列号12/393,921中描述了一种示例性的自供电双电极传感器，该专利为了所有目的通过引证而结合于此。在某些实施方式中，自供电传感器所提供的电流的水平可能较低，例如在毫微安的等级。 
插入组件 
提供了用来将医疗装置安装至对象的插入组件。在一些实施方式中，插入组件包括插入物和医疗装置本身。可将插入物构造为将各种医疗装置插入对象体内，例如分析物传感器、输液装置或套管。在一些实施方式中，可将插入物构造为在相同或不同的时间或位置安装这种装置的组合，例如组合式传感器/输液装置，等等。例如，在某些实施方式中，可将给定插入物构造为在不同的时间安装第一装置和第二装置。在这点上，插入物可以是可重复使用的。例如，插入物可以是可更改的，以与不止一种医疗装置一起使用，以包括不止一种类型的医疗装置，例如通过附接适配器和/或移除拆卸插入物的一部分。插入物可将医疗装置安装在对象皮肤中、其下方或穿过其中，或将医疗装置放在皮肤表面上。医疗装置可包括诸如倒刺(barb)、拉片(tab)、粘附剂等的特征或结构，以在插入之后将装置相对于皮肤保持就位。插入物装置还可用作小刀，例如，以不插入或安装医疗装置而刺穿皮肤。 
在一些实施方式中，插入组件包括插入物、分析物传感器和电源。可通过插入物将电源与分析物传感器同时插入。在其他实施方式中，在安装分析物传感器之后或之前安装电池。在这种情况中，可用插入物施加电源或单独地施加。电源可用来对传感器提供电流和/或电压，和/或提供功率以将一个或更多个信号传递至监视器单元。 
在一些实施方式中，插入组件包括插入物、医疗装置(例如分析物传感器)和体上电子装置。可通过插入物将体上电子装置与分析物传感器同时构造和/或安装。在其他实施方式中，在安装分析物传感器之后或之前安装体上电子装置。例如，可通过插入物安装分析物传感器，然后可安装体上电子装置。 
在一些实施方式中，体上电子装置对分析物传感器提供电压或电流。在一些实施方式中，体上电子装置处理由分析物传感器提供的信号。在其他实施方式中，体上电子装置可包括用于将与分析物传感器提供的信号相关的信号提供给另一部件的通信功能，所述另一部件例如监测器单元、计算机或其他部件。在一些实施方式中，提供了通信电路，例如RFID天线。电源可用来对部分或所有这些功能供电。在一些实施方式中，例如经由电感耦合从监测器单元提供功率。 
插入物可包括多个不同的部件。例如，插入物可包括一个或更多个用于使尖端朝着对象的皮肤前进的部件。传感器和体上电子装置可由支撑结构支撑，例如支架。可提供用于使尖端和/或分析物传感器/支撑结构前进的驱动器。在一些实施方式中，将致动器与尖端和/或支撑结构直接或间接地接合，使得将用户施加给致动器的人力传递至尖端和/或支撑结构。在一些实施方式中，所施加的力在收回位置(设置于插入物内)和前进位置(朝着对象的皮肤设置)之间驱动尖端和/或支撑结构。在一些实施方式中，在通过接触从护套向内延伸的伸出部来安装之前，将传感器和体上电子装置保持在收回位置中。根据此实施方式，将传感器和体上电子装置暂时操作地保持在支撑结构与设置于护套内壁上的伸出部之间。 
插入物还可包括一个或更多个用于在允许分析物传感器和可选的体上电子装置保持在对象上的同时收回尖端的部件。用于收回尖端的该部件可包括牵引器(收回装置，retractor)。应理解，牵引器和致动器可具有相同的结构或包括一些公共部件。在一些实施方式中，牵引器与尖端直接或间接地接合，使得将由用户施加的人力从牵引器传递至尖端，以从皮肤收回尖端。在其他实施方式中，可提供驱动组件以收回尖端。例如，驱动组件可包括弹簧、马达、液压活塞等，以远离对象的皮肤地收回尖端。驱动组件还可包括线性驱动部件。 
在一些实施方式中，牵引器在用户启动后收回尖端。在这种情况中，当用户希望收回尖端时其启动牵引器。例如，牵引器可包括释放开关。在激活释放开关后，驱动组件(例如弹簧或其他驱动器)从皮肤收回尖端。在其他实施方式中，牵引器和致动器包括公共部件。在激活致动器以使尖端和分析物传感器前进之后，用户释放致动器，这允许驱动组件从皮肤收回尖端。 
在一些实施方式中，牵引器在插入启动之后不需要与用户进一步的交互便可收回尖端。例如，插入物可包括在尖端和支撑结构前进预定量后自动地收回尖端的特征或部件。在插入之后不需要用户进一步的动作即可启动尖端收回的插入物装置在这里被称为具有尖端的“自动”回收。 
插入物装置 
在图4至图5中示出了用于插入物的针插座的一个实施方式。针插座136支撑尖端124，其具有变尖的远端部分160。在一些实施方式中，如这里讨论的，在尖端124的壁部的至少一部分中设置纵向壁部开口或间隙162。将间隙162的长度N选择成，与插入部分30至传感器的近端保持部分48的长度相当，并且，在某些实施方式中，可以是大约3mm至大约50mm，例如大约5mm，或大约10mm，或大约15mm，或大约20mm。尖端124的长度L可以是大约3mm至大约50mm，例如5mm或更长， 或大约10mm，或大约20mm，或大约30mm，或大约50mm，并在传感器的插入部分30的长度和传感器14的插入部分30的所需深度的基础上选择长度L。在一些实施方式中，间隙的两个边缘之间的距离或间隔是大约0.2mm至大约0.5mm，例如大约0.22mm，大约0.25mm，等等。 
在图6至图8中更详细地示出了尖端124的远端部分160。如图6所示，在此实施方式中，尖端124具有基本上“C”形或“U”形的轮廓，但是可具有其他结构，例如基本上“V”形。在尖端124的壁部中设置纵向间隙162。图7示出了设置有有角度的末端的远端部分160。在一些实施方式中，有角度的末端可设置有第一有角度的末端部分164和第二较陡角度末端部分166。包括多个边缘和面的示例性结构提供锋利的点，以对对象减小穿透力、外伤和流血。传感器本体的远端部分具有尺寸为装配在插入尖端124的凹口162内的宽度，插入尖端124具有小于大约20至大约26口径的直径，例如为21口径至大约25口径，其中，在某些实施方式中，尖端是21口径或23口径或25口径。这种尖端可与具有宽度或直径为大约0.20mm至大约0.80mm(例如大约0.25mm至大约0.60mm)的至少由尖端承载的部分的传感器一起使用，其中，在一些实施方式中，传感器的至少一部分的宽度或直径是0.27mm或0.33mm或0.58mm。在一些实施方式中，尖端124由片状金属制成，并在横截面中折叠成基本上“V”形或“U”形或“C”形的结构。可用多种技术制造折叠的金属片以形成尖端124。例如，可用蚀刻片状金属技术来形成尖端124。以此方式，可形成具有非常尖的边缘的尖端，使得在插入过程中穿透皮肤不太疼痛。在其他实施方式中，可用顺序冲模技术来形成具有尖端边缘的复杂的片状金属形状，如图9所示。在一些实施方式中，可用塑料帽模制尖端124，使得可在插入物装配过程中处理尖端。此外，可用塑料模制冲切尖端，以加固“V”形、“U”形或“C”形的片状金属结构。在其他实施方式中，可形成激光切割的尖端。以此方式，可用激光形成壁部开口或间隙162以及第一角度末端部分164和第二较陡角度末端部分166。 
在另一实施方式中，可用利用图10所述的方法的标准皮下注射针形成尖端124。首先，将皮下注射针(具有圆形横截面)切割成尖端124所需的长度。接下来，压缩皮下注射针，使得其横截面从圆形永久地变形成椭圆形。然后，将皮下注射针的末端被研磨成一定的斜角以产生锋利的点，从而减小所需的穿透力，如之前讨论的。最后，用适当的技术移除针的顶部(例如研磨、电抛光等)。产生的尖端124具有“U”形结构并对传感器14的插入提供充足的空间。在一些实施方式中，可以相反的顺序执行末端研磨步骤和压缩步骤。 
由于压缩步骤，用户一开始可通过更大直径的皮下注射针开始，使得完成的尖端124将具有与之前描述的尖端相似的尺寸。 
图11至图12示出了体上壳体122相对于针插座136和尖端124的位置。可将体上壳体122构造为保持传感器14的至少一部分和传感器控制单元12。如图11所示，尖端124延伸穿过体上壳体122中的孔168。因此，在一些实施方式中，将尖端124与体上壳体122分离。通过尖端124定位传感器14的远端部分。如在图12中进一步示出的，将传感器控制单元12的电子装置80(例如包含体上单元16的电子元件的印刷电路板)，并且传感器插孔123定位在体上壳体122内。传感器14可包括定位结构或缝隙127，定位结构或缝隙容纳定位件(例如传感器插孔123的拉片129)。提供电源82，例如电池，例如单次使用可抛弃型电池，或可充电的电池。在一些实施方式中，电源82用来对传感器提供电压或电流。在使用无源通信协议(例如无源RIFD)的实施方式中，不对通信提供电源。用监测器单元18提供这种电源(功率)。在一些实施方式中(其中，用传感器控制单元发送一个或多个信号)，可用一个或多个电源对这种通信电路提供功率。在一些实施方式中，电池的有效使用寿命可超过传感器14的有效使用寿命。 
图13示出了体上壳体122相对于插入物(例如图13至图17所示的插入物500)的尖端124的方向的横截面图。如这里讨论的，在一些实施 方式中，将传感器14设置在基本上弯曲的结构中，使得传感器的一部分(例如插入部分30和近端保持部分48)是基本上竖直的(即，基本上与插入物的纵向轴线对准并基本上垂直于皮肤表面)，并且，将接触部分32(以轮廓示出)定向在基本上水平的结构中，并与数据处理单元电子装置(例如电路80)电接触。传感器拉片50可被包围在体上壳体122(“二次模制(overmolded)”)的塑料中并固定就位。凹口56对传感器14提供进一步的稳定性，例如，通过允许用体上壳体122的材料包围传感器拉片50，并进一步提供用于在安装过程中竖直地定向传感器14的装置，通过允许相对于体上壳体122的竖直标志竖直地定位凹口56。 
可将安装有体上壳体122的传感器14设置在支架130的凹槽内，例如支架130中的凹入凹槽。可替换地，可将安装有体上壳体122的传感器14设置在支撑结构与从护套的壁部延伸的一个或多个伸出部之间。在又一替代方式中，可用与尖端124接合的可释放摩擦配合将安装有体上壳体122的传感器14保持就位。以此方式，支架不需要具有将安装有传感器壳体的传感器设置于其内的凹槽。在插入物的初始结构中，尖端124延伸穿过形成于支架130中的纵向孔168。在一些实施方式中，使孔168具有适当的大小，使得尖端124或针插座136都不会接触支架130。因此，一方面针插座136(和尖端124)以及另一方面支架130(图13)和体上壳体122同时但是彼此独立地运动。在其他实施方式中，可在孔和尖端之间提供摩擦配合。 
将传感器14的插入部分30和近端保持部分48设置在尖端124内的纵向孔162内(例如见图6)。将近端保持部分48设置在尖端124的纵向孔内，并对传感器14在尖端124内的安装提供额外的稳定性。将尖端124的纵向壁部间隙或开口162与传感器14对准，使得拉片50和接触部分32从尖端124横向地向外延伸。 
在图14至图17中示出了插入物的一个实施方式，并表示为插入物500。在一些实施方式中，插入物500的最大直径为大约30mm至大约60 mm，例如大约40mm，大约43mm，大约43.5mm，大约50.5mm，大约54.5mm，等等。在一些实施方式中，插入物500的最大高度为大约40mm至大约80mm，例如大约44mm，大约46mm，大约50mm，大约53mm，大约67mm，大约71mm，等等。在一些实施方式中，插入物500的体积为大约35cm3至大约110cm3，例如大约40cm3，大约41cm3，大约50cm3，大约60cm3，大约61cm3，大约62cm3，大约69cm3，大约70cm3，大约79cm3，大约90cm3，大约106cm3，等等。最大高度是从致动器514到护套542的远端表面512测量的。体积测量为波纹管部分502和从波纹管部分502伸出的护套542的部分。 
插入物500包括波纹管部分502、护套542和用于对容纳于其中的医疗装置和尖端保持无菌环境的可移除的远端帽504。如图15所示，将远端帽504示出为从护套542移除。护套542限定放在对象皮肤上的远端表面512。可用插入物500使医疗装置进入对象的皮肤。在一些实施方式中，压缩波纹管部分502，以使医疗装置进入对象的皮肤。波纹管部分502包括一系列同心折痕(fold)，折痕包括凸起部分516和折叠部分518。 
在图16中示出了在使用前且在移除帽部504前的插入物500的横截面，经由护套上的螺纹510和帽部504上的螺纹的相互接合将帽部504附接至护套542。帽部504包括干燥剂片590。帽部504可进一步包括用于在使用前用于保持尖端524在护套542内的位置的容器。 
如图16所示，插入物500包括这样的初始结构：将波纹管部分502设置在放松的延伸位置中。在这种结构中，将尖端524设置在与粘附层518的孔520隔开的位置中。波纹管部分502的近端部分包括按钮或致动器部分514。在远端从致动器部分514延伸的是侧壁528和针插座536。致动器部分514上的向下的力导致针插座536上和支架530上的向下的力(通过与侧壁528接合)。支架530包括用于在其中容纳体上壳体122的凹槽532。另外，支架530包括横向作用的弹簧臂，弹簧臂与体上壳体122外围上的棘爪特征接合，并允许在完成插入后简单地释放体上壳体122。尖 端524从插入物500内的针插座536纵向地延伸。在一些实施方式中，相对于皮肤表面以斜角(例如大约0°和90°之间)支撑尖端。 
图17示出了插入过程中的插入物500的横截面图。波纹管部分502克服弹簧546的偏压相对于护套542的按下导致了支架530和尖端524从近端位置朝着远端位置的远端纵向运动。在这种向下的近端运动的过程中，在致动器514附近的上部(近端)部分和护套542附近的下部(远端)部分之间压缩弹簧546。当在远端推动尖端524时，其携带传感器14(图12)的传感器插入部分30进入对象的皮肤S的皮下部分中。在一些实施方式中，可使用支架530和护套542之间的粘附层，需要用户超过最小力阈值以破坏该粘附接合，从而允许出现支架的远端运动。 
通过移除致动器部分514上的向下的力，弹簧546的偏压提供向上的(近端)力，其允许从对象的皮肤S收回尖端524。在一些实施方式中，波纹管502可提供完全向上的(近端)力，以从皮肤S收回尖端524。 
在图18至图24中示出了示例性驱动器设备，并表示为驱动器设备3600。应理解，这里描述的驱动器设备3600(以及驱动器设备3700、3800、3900和4000)被设计为与这里描述的任何插入物一起使用，插入物例如插入物500(见图14至图17)或可替换地插入物2400(见图44至图58)。此外，在某些实施方式中，可将驱动器设备3600(以及3700、3800、3900和4000)构造为与任何插入物设备一起使用，所述插入物设备包括致动器按钮或用于使医疗装置至少部分地进入患者皮肤的驱动器。因此，虽然将驱动器设备3600(和3700)示出为与插入物500配合，但是应理解，装置的这种组合并非意在包含驱动器设备和插入物的所有组合。类似地，虽然和插入物2400一起示出驱动器设备3900(和4000)，但是应理解，装置的这种组合并非意在包含驱动器设备和插入物的所有组合。例如，除了其他特征以外，这里公开的驱动器设备提供“按钮推动”能力，其中，驱动器设备可与致动器按钮接合，或者插入物的驱动器附接至驱动器设备。 
这里描述的驱动器设备的另一特征是模块性。在一些实施方式中，驱动器设备和插入物均可独立地操作。例如，插入物可包括致动器按钮或开关，以在不使用驱动器设备的情况下使医疗装置进入患者的皮肤。在一定程度上，驱动器设备提供致动能力，可与任何插入物一起使用，插入物具有可与驱动器设备的驱动器接触的启动按钮。在一些实施方式中，模块性允许将驱动器设备设计为用于多次使用，并且插入物装置能够单次使用。在其他实施方式中，插入物也能够多次使用，例如，通过在每次使用时更换传感器和/或体上壳体。 
驱动器设备3600包括用于相对于插入物定位的壳体3602。提供可相对于壳体3602纵向地移动的加载元件3604。在一些实施方式中，驱动器设备3600设置有致动器，例如用于旋转凸轮3606，凸轮提供插入物的自动启动。在使用中，按下启动按钮3620(在箭头E的方向上)，以将齿条3610与小齿轮3612连接(图18)。如图18所示，一旦按下启动按钮3620，便向下按下加载元件3604(在箭头D的方向上)，以克服扭簧3614的偏压在第一方向F上旋转凸轮3606。触发按钮3618将弹簧保持在加载位置，直到按下为止。 
如图20所示，相对于插入物500定位驱动器设备3600。虽然在图20至图24中示出了插入物500，但是应理解，任何插入物均可与驱动器设备3600一起使用。在一些实施方式中，将壳体3602的尺寸以及凸轮3606的位置与形状选择为，与一些实施方式中的插入物的尺寸相互作用。例如，可将壳体3602设计为用于与插入物500的护套542搭扣配合或摩擦配合。 
如图21所示，移除插入物500的帽部504(未示出)，从而允许将粘附剂518(未示出)放在对象的皮肤上。为了插入尖端524(未示出)，可按下释放按钮3618(箭头H)。 
图22至图24示出了驱动器设备3600驱动尖端524进入对象皮肤的运动的顺序。如图22所示，在按下释放按钮3618后，释放扭簧3614，从 而通过扭簧3614的偏压在方向J上驱动凸轮3606旋转。凸轮3606包括具有伸出部3607的表面。如图23所示，凸轮3606的进一步旋转导致伸出部3607接合插入物500的致动器按钮514。因此，压缩波纹管502和弹簧546，并使针插座536和支架530在远端前进(朝着对象的皮肤向下)。未在图22至图24中示出。参见例如图16)。将包含传感器14的尖端524驱动进入对象的皮肤，并将体上壳体122粘附至粘合剂518(未示出)。扭簧的进一步展开导致凸轮3606进一步旋转，这导致伸出部3607与致动器按钮514隔开，如图24所示。结果，收回弹簧546(未示出)的弹簧偏压使波纹管502返回至其扩展结构，并从对象的皮肤收回尖端524，留下传感器至少部分地植入皮肤中。 
在图25至图31中示出了用于致动插入物的另一示例性驱动器设备，并表示为驱动器设备3700。在一些实施方式中，驱动器设备3700是可重复使用的设备，而插入物可以是一次性装置。驱动器设备3700与驱动器设备3600基本上相同，这里指出了并在附图中表示了主要差异。 
如图25和图26所示，驱动器设备3700包括用于相对于插入物定位的壳体3702。提供可相对于上壳体3705纵向地移动的加载元件3704。在一些实施方式中，致动器3706是提供插入物的自动启动的往复元件。在使用中，加载元件3704克服驱动弹簧3714的正常偏压沿着轨道3710横向地前进(箭头K的方向)。在加载驱动弹簧3714后，锁定机构3718保持弹簧3714的加载。 
如图27所示，将驱动器设备3700相对于插入物500定位。虽然在图27至图31中示出了插入物500，但是应理解，任何插入物可与驱动器设备3700一起使用。如图28所示，移除插入物500的帽部504(未示出)，从而允许将粘附剂518(未示出)放在对象的皮肤上。为了插入尖端524(未示出)，可按下释放按钮3718(箭头L)。 
图29至图31示出了驱动器设备3700驱动尖端524进入对象皮肤的运动的顺序(见图16)。如图29至图31所示，在按下释放按钮3718后，释放驱动弹簧3714，从而通过弹簧3714的偏压在方向M上驱动滑动件3707。将滑动件3707由于其定位在轨道3710中而被限于横向运动。类似地，将致动器3706由于其定位在轨道3709中而被限于纵向运动。用曲柄构件3720将滑动件3707与致动器3706接合，曲柄构件3720在一端与滑动件3707枢转地连接并在另一端与致动器3706枢转地连接。如图30所示，滑动件3707的进一步横向运动导致致动器3706在远端前进并接合插入物500的致动器按钮514。因此，压缩波纹管502(未示出)，并使针插座536和支架530在远端前进，从而将尖端524驱动入对象的皮肤中并将体上壳体122(见图16)粘附至粘合剂518(未示出)。例如见图16，用于粘合剂518。滑动件3707的进一步横向运动导致致动器3706在近端前进，如图31所示。结果，收回弹簧546(例如见图16)的弹簧偏压使波纹管502返回至其扩展结构，并从对象的皮肤收回尖端524。 
在图32至图43中示出了用于致动插入物的驱动设备，并表示为驱动器设备3800。在一些实施方式中，驱动器设备3800是可重复使用的设备，而插入物可以是本文描述的插入物500。驱动器设备3800与致动器3600和3700基本上相同，这里指出了并在附图中表示了主要差异。 
如图32和图33所示，驱动器设备3800包括用于相对于插入物(例如这里描述的插入物500)定位的壳体3802。提供可相对于壳体3802纵向地移动的加载元件3804。按下加载元件导致转子3808克服扭簧(未示出)的偏压旋转。锁定元件(未示出)保持扭簧的加载。 
在图34至图43中示出了驱动器设备3800的致动的放大图。如图34所示，驱动器设备3800包括触发器3810、凸轮3808、启动按钮3812、扭簧3814、轴3816、棘爪3818、致动器3806和复位弹簧3820。为了启动驱动器设备3800，按下加载元件3804(未示出)，导致向下推启动按钮3812，卷绕轴3816并由此卷绕扭簧3814(图35)。棘爪3818将轴3816 锁定就位(图36)。在用户按下加载元件3804之后，启动按钮3812返回至其原始位置，同时用棘爪3818(图37)将轴3816保持就位。 
为了启动驱动器设备3800，用户再次推动加载元件3804。这导致触发器3810向下运动，导致释放凸轮3808。在一些实施方式中，用加载元件3804替代地按下启动按钮3812和触发器3810。然后，用扭簧3814(图38)向前驱动凸轮3808。在一些实施方式中，用第一加载元件按下启动按钮3812，并用第二加载元件按下触发器3810(未示出)。 
当凸轮3808旋转时，其向下推致动器3806(图39至图40)。在行程结束时，稍作停留。这允许保持传感器本体并将其按在粘性皮肤贴片上(图41)。在完全旋转之后，用触发器3810使凸轮3808停止，如图43所示。复位弹簧3820向回推致动器3806。当由对象释放触发器3810时，凸轮3808继续旋转，直到其处于原位为止，从而允许再次使用驱动器设备3800(图43)。 
继续参考图33，插入物500支撑体上壳体122和传感器14。用尖端(未示出)使传感器进入患者的皮肤。致动器3806接触插入物500的致动器14(该致动器基本上与致动器514相同)，以朝着对象的皮肤向下驱动尖端和传感器。 
在图44中示出了根据另一示例性实施方式的插入物2400。在一些实施方式中，插入物2400的最大直径为大约30mm至大约60mm，例如大约40mm，大约43mm，大约43.5mm，大约50.5mm，大约54.5mm，等等。在一些实施方式中，插入物2400的最大高度为大约40mm至大约80mm，例如大约44mm，大约46mm，大约50mm，大约53mm，大约67mm，大约71mm，等等。在一些实施方式中，插入物2400的体积为大约35cm3至大约110cm3，例如大约40cm3，大约41cm3，大约50cm3，大约60cm3，大约61cm3，大约62cm3，大约69cm3，大约70cm3，大约 79cm3，大约90cm3，大约106cm3，等等。最大高度是从壳体2402的顶部到壳体2402的底部测量的。体积测量为壳体部分2402的体积。 
参考图44，插入物2400包括壳体2402和用于保护容纳于其中的医疗装置和尖端的可移除的远端帽2412。壳体2402和远端帽2412可由任何适当的材料制成，例如金属、塑料等。在一些实施方式中，帽部2412可由聚合物或塑料材料制成。 
在图45中示出了插入物2400的元件的分解图。如所示出的，当全部安装时，插入物2400通常包括活塞2405、弹簧2406、壳体2402、尖端2404、体上壳体122、尖端支架2408、粘性贴片218和帽部2412。 
在图46中示出了尖端支架2408的更详细的视图。针支架2408将尖端2404相对于自身保持在插入物2400内的固定位置中，从而允许其在以后使用的过程中安全地穿透对象的皮肤。 
为了装配插入物2400，将尖端2404插入通过体上壳体122中的开口，如图47所示。针支架2408防止尖端2404完全插入通过体上壳体122。在一些实施方式中，体上壳体122包括分析物传感器14和传感器控制单元12。 
接下来，如图48至图50所示，装配活塞2405、弹簧2406和壳体2402。活塞2405包含插入弹簧2406的中心的弹簧保持件。当装配时(图44)，活塞2405的唇缘2414与壳体2402的内壁2416(未示出)接合。这导致弹簧2406被容纳在壳体件2402的唇缘2418与活塞2405的底面2424(未示出)之间。插入物2400的所形成的子组件允许活塞2405在近端位置与远端位置之间移动，在近端位置中，弹簧2406完全延伸，在远端位置中，底面2424与壳体2402的壁部2426接合。 
然后，将图47所示的传感器壳体组件插入图48至图50所示的插入物子组件中。如图50所示，将体上壳体122插入壳体2402中，尖端2404的末端指向远离活塞2405的地方。在图51中描述了所形成的组件。如图44所示，尖端支架2408上的凹槽与活塞2405上的拉片2422(未示出)接合。通过壳体臂部棘爪特征2440(未示出)将体上壳体122轴向地保持在壳体2402中。 
最后，将粘性贴片218放在壳体2402的开口上，并且，将帽部2412在壳体2402上搭扣配合，如图52所示。在图53中描述了完全装配的插入物2400。在一些实施方式中，粘附垫218在两面上均具有粘合材料。可在粘合垫218中设置中心孔220，以允许将尖端2404布置在对象的皮肤中。在插入过程中，尖端2404通过孔220并至少携带传感器一起进入对象的皮肤中。 
图54示出了插入物2400在移除远端帽2412之后、在使用前的初始结构的横截面图。如所示出的，尖端2404在插入物2400内纵向地延伸。在一些实施方式中，相对于皮肤表面以斜角(例如大约0°和90°之间)支撑尖端2404。 
在一些实施方式中，尖端2404是实心针。在一些实施方式中，尖端2404是设置有限定内孔的基本上圆柱形的结构，例如刚性的圆柱形构件或皮下类型的针。尖端2404还可在壁部中设置有细长的纵向开口或间隙。在一些实施方式中，尖端2404由金属片制成，并折叠成基本上“V”形或“U”形或“C”形横截面的结构，以限定纵向凹槽。 
按下活塞2405导致体上壳体122和尖端2404从近端位置向远端位置的远端纵向运动。在这种向下的远端运动过程中，在唇缘2418与底面2424之间进一步压缩弹簧2406。在体上壳体122可继续其向下的远端运动之前，棘爪2440提供克服所需的最小的力阈值。超过最小力阈值，通过体上壳体122向外推棘爪2440，然后体上壳体122移动到斜面2442上。体 上壳体122和壳体的斜面2442之间的摩擦将体上壳体122保持面对活塞2405。 
如图55所示，按下活塞2405使插入物2400从初始结构前进至展开结构。活塞2405和插孔2408在按下活塞2405的过程中的接触赋予尖端2404向下的力和随之发生的远端运动。当在远端推动尖端2404时，其使传感器插入部分30进入对象的皮肤S(未示出)的皮下部分中。活塞2405和传感器壳体122在按下活塞2405的过程中的接触赋予传感器壳体122向下的力和随之发生的远端运动。活塞2405的唇缘特征2414在远端运动的过程中保持传感器壳体122相对对象皮肤S的平行性。 
当活塞2405到达远端位置时，如图56所示，底面2424与壁部2426接合并防止进一步向下运动。体上壳体122的远端(下)表面与粘合垫218的上表面接合，从而粘附至对象的皮肤表面S。 
当对象或一些设备从推动器2405移除力时，弹簧2406朝着其近端位置推动活塞2405，如图57所示，留下体上壳体122粘附至对象的皮肤表面S。拉片2427(未示出)对体上壳体122提供额外的力，以帮助将其保持在粘性贴片218上，同时通过体上壳体122收回尖端2404。最后，由弹簧2406施加的向上的力使插入物2400返回至其初始结构，如图58所示。 
在一些实施方式中，可将插入物2400分配在消毒包装2480中，如图59所示。为了使用此结构的插入物2400，用户将首先用酒精清洗皮肤上的插入位置。然后，用户将从消毒包装2480移除插入物2400，如步骤1所示。接下来，对象将把插入物放在插入位置上并在活塞2405上向下推，直到将体上壳体122粘附至对象的皮肤为止，如步骤2至步骤3所示。然后，对象将释放活塞2405。最后，对象将从插入位置移除插入物2400并处置插入物。 
在另一实施方式中，图59所示的消毒插入物2400可利用图60所示的驱动器设备3900(图61至图79)。以此方式，传感器壳体单元的插入是半自动的，且可传递更一致的用户体验并减小用户错误的危险。在图61至图79中示出了一个示例性驱动器设备，并表示为驱动器设备3900。 
驱动器设备3900包括用于相对于插入物定位的壳体3902。提供可相对于壳体3902纵向移动的释放按钮3904。复位弹簧3906施加的力允许释放按钮3904在近端位置和远端位置之间移动，如图62至图65所示。 
如图61所示，将驱动器设备3900相对于插入物2400定位。虽然在图44至图60中示出了插入物2400，但是应理解，任何插入物可与驱动器设备3900一起使用。由于驱动器设备3900和适当的插入物可以是模块化的，所以将壳体3902的尺寸和释放按钮3904的位置与形状选择为，与插入物的尺寸相互作用。例如，可将壳体3902设计为用于与插入物2400的护套2402搭扣配合或摩擦配合。 
图62至图65示出了驱动器设备3900驱动尖端2404进入对象皮肤的运动的顺序。图62示出了触发之前的驱动器设备3900。如所示出的，驱动器设备3900包括壳体3902、释放按钮3904、复位弹簧3906、驱动器弹簧3908和活塞3910。在图67至图69中分别示出了壳体3902、活塞3910和释放按钮3904的三维透视图。释放按钮3904包括接合壳体3902上的唇缘3914的拉片3912，其防止复位弹簧3906的向上的力将释放按钮3904与壳体3902分离(见图66)。释放按钮3904还包括伸出部3918。 
活塞3910包括拉片3916(未示出)，其将活塞3910限制于壳体3902。将驱动器弹簧3908设置在释放按钮3904的底部与活塞3910的顶部之间。可替换地，驱动器弹簧3908可以在活塞3910所示的位置周围并由按钮3904的圆柱体压缩。 
如图63所示，在朝着壳体3902按下释放按钮3904后，复位弹簧3906和驱动弹簧3908变得压缩。同时，伸出部3918导致拉片3916与壳体3902分离。这允许驱动弹簧3908使活塞3910朝着插入物3900前进，如图64所示。将在其中包含传感器的尖端2404驱动进入对象的皮肤中，并将体上壳体122附接至粘合垫118。 
当对象释放按钮3904上的压力时，复位弹簧3906将其推回其初始位置。当按钮3904返回时，按钮的臂部将活塞3910的臂部拉回其初始位置，将拉片3916与壳体3902自动地重新接合(图65)。传感器保持插在对象的皮肤中。 
在图70至图79中示出了一个示例性驱动器设备，并表示为驱动器设备4000。 
驱动器设备4000包括用于相对于插入物定位的壳体4004。提供可相对于壳体4004纵向移动的外按钮4002。位于壳体4004和外按钮4002之间的复位弹簧(未示出)施加的力允许外按钮3904在近端和远端位置之间移动，如图73至图79所示。 
如图70所示，将驱动器设备4000定位在插入物2400的顶部上。虽然在图44至图58中示出了插入物2400，但是应理解，任何插入物可与驱动器设备4000一起使用。由于驱动器设备4000和适当的插入物可以是模块化的，所以将壳体4004的尺寸和释放按钮3904的位置与形状选择为，与插入物的尺寸相互作用。例如，可将壳体4004设计为用于与插入物2400的护套搭扣配合或摩擦配合。 
图71示出了驱动器设备4000的元件的分解图。如所示出的，驱动器设备4000包括外按钮4002、复位弹簧4006、内按钮4008、壳体4004、驱动弹簧4010和推动器4012。在图72中示出了装配的驱动器设备4000，其中，为了清楚起见，一些元件是部分透明的。 
图73至图79示出了驱动器设备4000驱动尖端2404进入对象皮肤的运动的顺序。图73示出了触发之前的驱动器设备4000。当装配时，将复位弹簧4006封装在外按钮4002和壳体4004之间。类似地，将驱动弹簧4010封装在内按钮4008的底部与位于活塞4012上的表面4020之间。 
外按钮4002包括引导件4013，其用拉片4022将内按钮4008锁定就位。内按钮4008包括允许外按钮4002相对于壳体4004移动的轨道4015。 
活塞4012包括允许其安装并固定在内按钮4008内的拉片4014。此外，活塞4012包括具有附件4018的臂部4016，附件4018具有接合壳体4004上的凸缘4017的开口。 
为了启动驱动器设备4000，对象在对象皮肤的方向上在外按钮4002上向下推，导致复位弹簧4006和驱动器弹簧4010变得压缩，如图75所示。最后，位于内按钮4008上的拉片4019导致附件4018被推得离开凸缘4017，如图76所示。 
附件4018从凸缘的移动允许驱动弹簧4010朝着插入物2400的活塞2405驱动活塞4012，如图76所示。最后，将尖端2404驱动进入对象的皮肤中，并将体上壳体122附接至对象，如图77所示。如果不存在插入物2400，那么，当活塞臂接合凸缘4017时或当拉片4014接合内按钮4008时，活塞最终停止其前进运动。 
为了从对象的皮肤移除尖端2404，对象必须从外按钮4002移除压力，外按钮4002允许复位弹簧4006在外壳体4002上施加向上的压力，如图78所示。引导件4013通过轨道4015拉起内按钮。内按钮4008用拉片4014拉起活塞4012。将推动器4008拉起得足够远，以重新接合凸缘4017上的拉片4018。这使插入物立即准备好重新使用，没有额外的步骤。同时，位于插入物2400中的复位弹簧从对象的皮肤收回尖端2404。复位弹簧4006最终使驱动器设备4000返回至其原始结构，如图79所示。 
应理解，这里描述的主题不限于所述特定实施方式，当然同样是可变化的。还将理解，这里使用的术语仅是为了描述特定实施方式的目的，并非旨在是限制性的，因为本主题的范围只由所附权利要求限制。 

Claims (13)

1.一种用于将医疗装置至少部分地插入通过对象的皮肤的设备，包括：
手柄，能够在近端位置与远端位置之间移动；
被所述手柄至少部分地围绕设置的护套，所述护套限定用于放置在所述对象的皮肤上的远端表面；
装置支撑部，用于在所述护套内支撑所述医疗装置，并限定通过其中的孔，所述装置支撑部与所述手柄接合；以及
尖端支撑部，用于支撑延伸穿过所述孔的尖端，并接合于所述装置支撑部；以及
其中，施加于所述手柄的力将所述医疗装置从近端位置移动至远端位置，使得所述尖端设置为穿过所述对象的皮肤。
2.根据权利要求1所述的设备，进一步包括用于在所述手柄处于所述远端位置中时保持所述装置支撑部的保持件。
3.根据权利要求1所述的设备，其中，所述装置支撑部接合于所述手柄，直到所述装置支撑部到达远端位置为止。
4.根据权利要求1所述的设备，其中，所述医疗装置包括体上壳体，所述体上壳体包括分析物传感器和传感器控制单元，并且其中，所述尖端支撑所述分析物传感器的远端部分。
5.一种用于将医疗装置至少部分地插入通过对象的皮肤的设备，包括：
护套，限定用于放置在所述对象的皮肤上的远端表面；
手柄，至少部分地围绕所述护套而设置并且能够在近端位置与远端位置之间移动；
装置支撑部，用于支撑所述医疗装置，并能够响应于所述手柄的远端运动相对于所述护套在近端位置与远端位置之间移动；以及
尖端支撑部，用于支撑尖端，并能够响应于所述手柄的远端运动相对于所述护套在近端位置与远端位置之间移动。
6.根据权利要求5所述的设备，其中，所述设备构造成用于单次使用。
7.根据权利要求5所述的设备，其中，所述设备构造成用于多次使用。
8.根据权利要求5所述的设备，进一步包括用于在所述远端位置中保持所述装置支撑部的保持件。
9.根据权利要求5所述的设备，其中，所述装置支撑部接合于所述手柄，直到所述装置支撑部到达所述远端位置为止。
10.根据权利要求5所述的设备，其中，所述医疗装置包括体上壳体，所述体上壳体包括分析物传感器和传感器控制单元，并且其中，所述尖端支撑所述分析物传感器的远端部分。
11.一种插入装置，包括：
壳体；
位于所述壳体内的体上壳体保持部件；
可移除的帽，能与所述壳体接合；
护套，接合至所述壳体并且部分地容纳在所述壳体内，所述护套限定用于放置在对象的皮肤表面上的远端表面；
体上壳体，所述体上壳体保持部件用于能释放地保持体上壳体，所述体上壳体包括分析物传感器和传感器控制单元；
推动器，接合至所述壳体并且设置在所述壳体内，用于响应于所述壳体相对于所述护套朝向所述远端表面移动而使所述体上壳体和一尖端沿插入物的纵向轴线从近端位置平移至远端位置；以及
尖端保持部件，所述尖端保持部件用于当所述推动器到达所述远端位置时将所述尖端从所述体上壳体移除。
12.根据权利要求11所述的插入装置，其中，当所述壳体朝向所述远端表面移动时所述护套后退至所述壳体中。
13.根据权利要求11所述的插入装置，其中，响应于所述壳体朝向所述远端表面移动，所述尖端刺入所述皮肤表面。
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Correction item: Inventor

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CI03 Correction of invention patent

Correction item: Inventor

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Free format text: CORRECT: INVENTOR; FROM: MANUEL L. DONNAY TO: MANUEL L. DONNAY; CURRY SAMUEL MASON; NGUYEN TUAN;; PETER G. ROBINSON; YEE PHILIP

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