CN101553176B - 可变速度的传感器插入设备 - Google Patents

可变速度的传感器插入设备 Download PDF

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CN101553176B
CN101553176B CN2007800453739A CN200780045373A CN101553176B CN 101553176 B CN101553176 B CN 101553176B CN 2007800453739 A CN2007800453739 A CN 2007800453739A CN 200780045373 A CN200780045373 A CN 200780045373A CN 101553176 B CN101553176 B CN 101553176B
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insertion equipment
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CN101553176A (zh
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加里·阿什利·斯塔福德
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Therasense Inc
Abbott Diabetes Care Inc
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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
    • A61B5/1468—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 using chemical or electrochemical methods, e.g. by polarographic means
    • 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
    • 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
    • A61B5/14546—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 analytes not otherwise provided for, e.g. ions, cytochromes
    • 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
    • A61B5/1486—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 using enzyme electrodes, e.g. with immobilised oxidase
    • A61B5/14865—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 using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors

Abstract

本发明公开了一种自动传感器插入器，其用于将经皮传感器置入活体皮肤中。根据本发明的各个方面，可由使用者来改变例如传感器插入速度的插入特性。在一些实施例中，插入速度的变化可通过改变驱动弹簧的压缩量实现。弹簧的压缩量可从具有连续变化范围内的设置值中选择和/或可从有限数量的离散设置值中选择。本发明还涉及了有关使用这种自动插入器的方法。

Description

可变速度的传感器插入设备
优先权 
本申请要求于2006年10月23日提交的题为“Variable SpeedSensor Insertion Devices And Methods Of Use”的美国专利申请No.11/552,072的优先权，其公开内容通过引用结合于此。 
技术领域
本发明涉及用于监测活体内的分析物的医疗设备，如监测糖尿病患者体内的葡萄糖水平。更具体地，本发明涉及用于将分析物传感器插入患者皮肤中的自动设备。
背景技术
近年来，糖尿病患者通常通过刺破指尖或其他身体部位而采血，将血液施加至手持式测量仪的一次性测试条上并使测量仪和测试条对血液进行电化学测试以确定当前的葡萄糖浓度，从而测得患者的血糖水平。这种离散的体外测试每天通常至少要进行几次。目前，正在研发连续的体内葡萄糖监测设备以代替体外设备。这类连续系统中的一些采用了一次性的经皮传感器(transcutaneoussensor)，该传感器被插入皮肤中以测量间质液中的葡萄糖浓度。该传感器的一部分从皮肤突出并与用粘合剂附着在皮肤上的耐用控制器和发送器单元相连接。无线手持单元与安装于皮肤的发送器和传感器结合使用，以定期接收葡萄糖读数，如每分钟一次。每三、五或七天，将该一次性传感器取出并替换以一个新的传感器，该新 的传感器再次与可重复利用的控制器和发送器单元相连接。利用这种布置，糖尿病患者可以利用手持单元连续监测他们的葡萄糖水平。于2001年1月16日授予TheraSense有限公司的美国专利NO.6,175,752中提供了对这种连续葡萄糖监测系统及其使用的详细描述，其全部内容通过引用结合于此。
经皮分析物传感器可以利用自动导入器或插入器设备而插进使用者的皮肤中，如2004年7月8日公开的公开号为20040133164的美国专利申请No.10/703,214中所描述的设备，该申请的全部内容通过引用结合于此。上述所公开的专利申请中描述的大多数传感器插入器设备具有两个弹簧，一个用于驱动导入器利刃和传感器进入患者皮肤，而另外一个用于收回导入器利刃，而将传感器留在患者皮肤下。该弹簧装置被选择为提供最优化的导入器利刃和传感器速度以将传感器插入特定患者体内。
发明内容
根据本发明的一些实施例的各方面，可以意识到的是，具有可变的插入速度、插入力、运动距离、加速度和/或其他传感器插入特性的传感器导入器可能是理想的，这些特性可以被调整而用于不同环境和/或不同患者。例如，由于生理因素以及可能因分析物传感器的高速自动插入而导致的外伤，从而可能需要减慢并控制穿刺器械的速度。在其他情况中，如对于具有诸如高于平均皮肤厚度和/或皮肤密度的不同皮肤特征的患者而言，可能期望加快刺破设备的速度。可替换地，在涉及将传感器插入患者的不同部位(如臂、躯干或大腿)的这些情况下，可能会受益于使用单独的插入器或具有插入速度可以加快或减慢的传感器的单独的插入器类型。根据本发明的其他方面，单独的插入器类型可以被构造为可替换地插入不同类型的传感器和/或其他设备，在这种情况下，可以根据当前正被插入的传感器或设备的类型来设定插入设置值(setting)。
根据本发明的其他方面，传感器插入设备可以设置有允许使用者在使用前调整传感器插入速度的可调整特性。
根据本发明的其他方面，传感器插入设备可以设置有允许插入速度在一个速度范围内进行可变调整的可调整特性。
根据本发明的其他方面，传感器插入设备可以设置有允许从有限数量的离散设置值中选择插入速度的可调整特性。
根据本发明的其他方面，传感器插入设备可以设置有允许通过改变驱动弹簧的压缩量来调整插入速度的可调整特性。在一个实施例中，可以通过使用旋钮(knob，钮)来调整弹簧压缩。在另一实施例中，可以通过转动拇指轮来调整弹簧压缩。在又一实施例中，可以通过改变插入器的部件的方向来调整弹簧压缩。在再一实施例中，可以利用一个或多个磁体来调整弹簧压缩。
根据本发明的各个方面，可以通过插入患者的传感器来监测各种分析物。这些分析物可以包括但不限于在体液样品中的乳酸盐、乙酰胆碱、淀粉酶、胆红素、胆固醇、绒毛膜促性腺激素、肌酸激酶(如CK-MB)、肌胺酸、DNA、果糖胺、葡萄糖、谷酰胺、生长激素、血细胞比容、血红蛋白(如HbA1c)、激素类、酮、乳酸盐、氧、过氧化物、前列腺特异性抗原、凝血酶原、RNA、促甲状腺激素和肌钙蛋白。监测系统还可被构造为确定药物的浓度，所述药物例如：抗生素(如庆大霉素，万古霉素等)、洋地黄毒苷、地高辛、滥用药物、茶碱、华法令阻凝剂等。可在血液、间质液和其他体液中对这样的分析物进行监测。
在某些实施例中，可以使用根据本发明各方面构造的插入器将其他类型的传感器插入身体中。这些传感器可以包括但不限于利用诸如机械、化学、电子、光学或其他方法来测量例如温度、压力、 呼吸、脉搏、运动以及电信号的物理参数的设备。除了将(多个)传感器插入身体内之外，根据本发明各方面构造的插入器可以插入药物、液体输送设备，如输液装置、套管或针头，或其他医疗设备。
附图说明
每个附图均以图解形式示出了本发明的各个方面。其中：
图1是示出了根据本发明各方面构造的传感器插入器和胶粘底座的示例性实施例的透视图。
图2是附着于患者皮肤的胶粘底座和传感器的透视图。
图3是附着于胶粘底座并向手持接收器发送信号的发送器的透视图。
图4是图1中所示实施例的分解透视图。
图5是图1中所示实施例的侧视图。
图6是图1中所示实施例的端视图。
图7是沿着图6中的线7-7的截面视图。
图8是沿着图5中的线8-8的截面视图。
图9是类似于图8的剖视图(broken away view)，示出了在中间位置的往返装置(shuttle)。
图10是类似于图8的剖视图，示出了在竖起位置的往返装置。
图11是类似于图8的剖视图，示出了在插入位置的往返装置。
图12是沿着图5中的线12-12的截面视图。
图13是经皮可植入传感器的透视图。
图14A是传感器导入器的透视图。
图14B是图14A所示的导入器的仰视图。
图15是往返装置构件的透视图。
图16A是传感器插入器成套工具(sensor inserter kit)的可替换实施例的透视图。
图16B是图16A所示组装的一些部件的分解图。
图17是示意性示出了传感器插入器的可替换实施例的侧视图。
图18A是示意性示出了传感器插入器的可替换实施例的侧视图。
图18B是示意性示出了图18A的传感器插入器的俯视图。
图19A是示意性示出了传感器插入器的可替换实施例的侧视图。
图19B是示意性示出了图19A的传感器插入器的俯视图。
图20A是示意性示出了传感器插入器的可替换实施例的侧视图。
图20B是示意性示出了图20A的传感器插入器的俯视图。
可以预期本发明的不同于图中所示实例的变型。
具体实施方式
下面的描述集中于本发明的一些变型。本发明的这些变型被看作为非限制性的实例。应当理解的是，本发明不限于所阐述的一种或多种特定变型，并且当然可以改变。在不背离本发明的真实精神和范围的情况下，可以对所描述的本发明进行改变，并且可以对等价物进行替换(无论是目前已知的还是将来开发的)。另外，可以做出修改以使特定的环境、材料、物质成分、工艺、(多个)工艺过程或(多个)步骤适应于本发明的(多个)目的、精神或范围。
参照图1-图20，将描述根据本发明的某些方面构造的传感器插入器的示例性实施例。图1示出了传感器插入器成套工具300的整体透视图，其包括一次性使用的(single-use)传感器插入器310以及可卸下地附着于其底部的一次性使用的胶粘底座312。
总览该实施例的插入器成套工具300的操作，通常该成套工具可以如图1所示进行组装，其中传感器314(图4和图25所最佳示出的)预装在插入器310内并且插入器310处于“竖起(cocked)”状态。在皮肤上准备好插入部位(通常插入部位位于腹部区域)后，患者可以将上衬垫316和下衬垫318从胶粘底座312上取下，以露出位于底座312下面的胶带320的底表面和部分上表面(如图4中最佳示出的)。然后可以将连接有插入器310的底座312应用于患者皮肤的插入部位处。可以将安全锁翼片322一起挤压以允许按下致动器按钮324而使得插入器310发射(fire)，由此将传感器314以预定速度和力量插入患者的皮肤中。一旦传感器314被插入皮肤中，患者便可以通过按压插入器310相对侧上的释放翼片326并将插入器310抬起离开底座312，而将插入器310从底座312取下。
参照图2，根据这一示例性实施例，示出了已插有传感器314的底座312被粘在患者皮肤328上。一旦将插入器310从底座312上移除，发送器330就可以滑动到位。在发送器330完全位于底座312上之后，发送器330的电路即可与传感器314上的接触点进行电接触。一旦完成初始化和同步程序，来自传感器314的电化学测量值可以从发送器330无线传输至手持式接收器332，如图3所示。传感器314、底座312和发送器330可以在患者身上保留预定的时间，如三天、五天或七天。之后可以将这些部件取下，从而可以适当地丢弃传感器314和底座312。接着可以使用新的插入器310、传感器314以及底座312，并再次利用发送器330和接收器332来重复上述整个过程。
参照图4，插入器成套工具300可以由下列部件如图所示进行组装：壳体334、致动器按钮324、驱动弹簧336、往返装置338、导入器利刃340、传感器314、回位弹簧(retraction spring)342、插入器基座(base)344、上衬垫316、胶粘底座312、胶带320以及下衬垫318。
传感器314可以具有主表面346，其可滑动地安装在导入器利刃340的U型轨道348之间并通过传感器凹入部350可释放地保留在那里，该传感器凹入部与导入器凹入部352相接合。导入器利刃340可以通过诸如粘结、热熔或超声焊的方法安装至往返装置338的表面354。传感器314还可以具有表面356，该表面从主表面346垂直地延伸并且当安装上之后正好位于往返装置338的驱动表面358之下(在图7和图13-图15中更好地示出了这些特征的细节)。
往返装置338可通过弓形引导件360可滑动但不能转动地限定在基座344上。如图7、图12和图15所最佳示出的，往返装置338通常可由通过两个桥接件366连接的外环362和内部杯形支柱364而构成。桥接件366在形成于引导件360之间的两个狭槽368之间 滑动，并且允许往返装置338沿着引导件360移动但不转动。回位弹簧342可以在其外圆周处由引导件360约束(captivated)，在其底部由基座344的底板370约束，在其顶部由桥接件366约束，并且/或者在其内圆周处由往返装置支柱364的外表面约束。驱动弹簧336可以在其底部和外圆周处由往返装置支柱364的内表面约束，在其顶部由致动器按钮324内的顶板372约束，并且/或者在其内圆周处由从顶板372悬垂的杆部374约束。当驱动弹簧336在致动器按钮324与往返装置338之间被压缩时，它向着基座344推动往返装置338。当回位弹簧342在往返装置338与基座344之间被压缩时，它向着致动器按钮324推动往返装置338。
致动器按钮324可以自下方可滑动地容纳在壳体334内，并以有限的纵向移动保持在壳体334顶部处的开口376内。致动器按钮324每一侧上的臂378可以沿着壳体334的内壁在通道380内移动，如图8最佳地示出。致动器按钮324的纵向移动可以通过臂378的基底与位于壳体334顶部的开口376的边缘相接触而在一个方向上受到限制，而通过臂378的远端384与通道380中的挡块386相接触而在另一方向上受到限制。在本实施例中，在壳体334的顶部设置有狭槽388以便于壳体的制造，并且因此可以插入工具以便向内按压臂378使之越过挡块386，从而允许将致动器按钮324从壳体334上取下，如果需要的话。
当传感器314、导入器340、往返装置338、回位弹簧342、驱动弹簧336和致动器按钮324如上所述及图4所示装配在基座344与壳体334之间时，可以将壳体334扣(snap)在基座344上的适当位置中。通过与壳体334中的上开口392相接合的上基座钩390以及与壳体334中的下开口396相接合的下基座钩394(图5中最佳示出)，可以将基座344保持在壳体334内。在该实施例中，设 置狭槽398和400以便于壳体334的制造，并且如果需要的话，可以利用工具将基座344从壳体334拆下。
参照图7，致动器按钮324可以设置有安全锁翼片322，这些翼片铰接地形成在相对端上。翼片322可以从松驰的外部位置被推至收缩的内部位置。当在正常的外部位置时，翼片322的外表面上的侧翼402接合开口376的边缘404，以防止致动器按钮324被按下，因此避免了插入器310的意外发射。翼片322可以向内挤压而足以越过开口376的边缘404，并同时按下致动器按钮324以发射插入器。可替换地，翼片322可以进一步向内挤压而使内部边缘上的倒钩406与位于致动器按钮324中心部分的钩子408相接合，由此打开安全锁以允许稍后通过简单地压下致动器按钮324进行发射。在该实施例中，在翼片322上设置有向上延伸的把手410以便更好地提供有关安全锁状态和致动控制的直观指示。
参照图8，往返装置338可以设置有横向延伸的有倒钩拨爪(barbed finger)412，其沿着壳体334的内壁在通道380内移动。在该实施例中，当将往返装置338向上插入壳体334中足够远时，有倒钩拨爪412即刻向内偏转，并且然后再向外扣住挡块386。在所示的该“竖起”位置中，驱动弹簧336可被压缩并且朝向基座344推动往返装置338，但有倒钩拨爪412扣住挡块386从而阻止了这种移动。
参照图9-图11，将描述示例性插入器310的装载、竖起、准备、发射以及自动收回的一系列操作。根据本发明的各方面，在生产期间，除传感器314之外，插入器310可以由一个卖方进行制造并完全组装，而该传感器可由第二个卖方供应并在无菌环境中安装。因此，可以制造插入器310并将其在如图9所示的中间状态(neutralstate)运送给传感器卖方。穿过致动器按钮324中心设置的孔414允许传感器卖方将销针插入(手动地或通过机械自动地，未示出) 并穿过孔414，以通过可控方式朝向基座344驱动往返装置338并逆着回位弹簧342的力将往返装置保持在那里。这将允许导入器利刃340延伸穿过基座344(如图11所示)，从而传感器314可以被装进导入器340中。当将销针取出时，往返装置338、导入器340和传感器314可被允许返回中间位置中。于是，传感器卖方可通过穿过基座344(底座312已被取下)内的中央孔416从相反方向将另一个销针(未示出)推进直到销针接触到形成在往返装置338底部的凹入部418，以便在运输前将已装载的插入器310竖起。通过朝向致动器按钮324推动往返装置338直至有倒钩拨爪412越过挡块386，插入器310即可被竖起(如图10所示)。
参照图10，患者可以接收到处于所示的竖起位置的插入器310。为了使用插入器310，患者可以将底座312置于安装位置处并可以如前所述打开安全机构，并且随后可以逆着驱动弹簧336的力推动致动器按钮324。当致动器按钮324朝向基座344移动时，驱动臂378上的凸轮表面420接触有倒钩拨爪412的倾斜表面422并向里推动它们。当拨爪412被向内驱动足以越过挡块386时，往返装置338可以被驱动弹簧336以预定速度和力量驱动至插入位置，如图11所示。
参照图11，示出了示例性插入器310处于插入位置中，其中导入器利刃340的尾部424延伸穿过基座344和底座312进入患者皮肤中。图11示出了在完全延伸位置的往返装置338，其下表面426降至基座344的最低点。然而，在该实施例中，传感器314的下垂直表面356将与胶带320(胶带320由患者皮肤自下支撑)顶部上暴露出的传感器接触部分428(图2和图4最佳示出的)相接触，并且因此通常将在伸出所示的最低位置之前停止运动。导入器利刃340的尾部424可以具有刚性并具有皮肤穿刺边缘430，以允许传感器314的柔性尾部431插入患者皮肤。在提供该功能后，可以立 即将导入器利刃340从患者身上取下并在回位弹簧342(已通过往返装置的移动而被压缩)将往返装置338朝向致动器盖推回时收回至壳体334内的安全位置中。通过胶带320(粘结至传感器314的垂直表面356)顶部上的传感器接触部分428，可将传感器314从导入器340上拉下并保持在适当的位置中。传感器凹入部350和相匹配的导入器凹入部352的几何形状可以选择为使得在它们之间产生的分离力小于垂直表面356粘在胶带320上的粘着力，但足够大以在常规货运和产品装卸冲击载荷过程中将传感器314保持在导入器340内。往返装置338下面的驱动表面358可以向下压在垂直表面356的顶部上，以在往返装置338收回到导入器340之前保证其与胶带320的良好接触。还可以在传感器尾部431上采用(多个)倒钩以进一步将传感器锚固在其操作位置中。
再次参照图9，在该实施例中，发射之后回位弹簧342将使往返装置338返回所示的中间位置，但不包括已保留在患者皮肤内的传感器314(不像这里所示的仍留在导入器340内)。驱动弹簧336可以被设计为比回位弹簧342更硬，从而使往返装置338的振动快速消除，并且因此导入器利刃340不返回至传感器314或患者而导致伤害。现在传感器314被插入患者皮肤中，可以通过向内弯曲插入器310相对侧上的释放翼片326以将挂钩432从安装通道434中卸下并随后抬起插入器310使其离开底座312，来将插入器310从底座312上取下。在处理插入器310期间导入器利刃340仍保护在壳体334内。发送器330现在可以滑进底座312内，如前所述。
在一个实施例中，传感器314可以由0.005英寸厚的Mylar基板制成，如Dupont Melinex ST-505，双面印刷处理、热稳定并双轴定向。在该实施例中，主表面346为0.315高、0.512宽，并且垂直表面356为0.374宽、0.202深。传感器尾部431为0.230长、0.023宽。半球形传感器凹入部350为0.050英寸宽、0.026英寸深。导入 器340由SUS 301医用级不锈钢制成，0.004英寸厚，具有小于或等于0.5微米的表面粗糙度。导入器340的主体部分的高度为0.614英寸，并且其内部宽度为0.513英寸。辊压轨道348的整体厚度为0.026英寸。导入器尾部424的长度和宽度分别为0.354和0.036英寸。利刃340的优选角度为21度。半球形导入器凹入部352具有0.024英寸的半径。而且，在该实施例中，往返装置338具有至少1米/秒的平均速度，并且在其行程的终点处具有约2.65磅-米/秒的动量。
在上述的示例性实施例中，壳体334、按钮324、往返装置338、基座344以及底座312均由G.E.Lexan PC注模成型。按钮324上的臂378的内外工作表面均由Dow Corning 360 Medical Fluid(道康宁公司360医用硅油)润滑。驱动弹簧336具有1.25英寸的自由长度、1.00英寸的工作长度以及每英寸20至30磅的比率(rate，刚度)。回位弹簧342具有1.5英寸的自由长度、0.35英寸的工作长度以及每英寸0.15至0.35磅的比率。胶带320是带有具硅释放功能的半漂白牛皮纸衬垫的聚脂薄膜(如Acutek(安泰维信)0396013)上的医用级丙烯酸粘合剂。
下面的改进可以附加于上面所述的插入器成套工具300上以起到提高传感器插入可靠性的效果。首先，如图13所示，可以沿着传感器314的顶部边缘形成传感器翼(flap)466。当传感器314到达图11所示的延伸的释放位置(delivered position)时，翼466扣在基座344的底部边缘468上，如图7所示，以保证当往返装置338向上返回至收缩位置时传感器314与导入器340分离。在垂直的传感器表面356的底部上也可以具有粘合剂，以确保传感器314粘在粘结安装胶带320顶部的传感器接触部分428处，如图4所示。
参照图16A和16B，其中示出了一个可替换实施例。通过将驱动弹簧336的上端锚固在壳体桥接件470上，可以制造便于年长患 者推动的致动器按钮324′来替代按钮324。这一选择还可以使得插入器310的插入力更加可靠，并且如果需要的话，可以允许使用更强的弹簧力。桥接件470可以横跨开口376′，并在壳体334′顶部将其分成两个开口472。按钮324′的顶部可以分成两个突出部474，每个突出部均延伸穿过一个开口472。可以设置穿过按钮324′中心的通孔，以允许驱动弹簧336从孔中通过并稳固在从桥接件470的底部中心悬垂下来的支柱(未示出)周围。
可以设置安全锁键476，以防止在移开键476之前按下致动器按钮324′。在桥接件470的顶部中心可以设置孔478，以便容纳位于键476底部的凸起480，从而允许键476旋转。在图16A和16B所示的实施例中，当键手柄482旋转至垂直于按钮突出部474时，键476上的两个相对的垂直翅片(fin)484转进突出部474内部面向内侧的狭槽(未示出)中，并防止按钮324′被致动。当键手柄482和翅片484旋转为平行于按钮突出部474时，使得翅片484与前述狭槽脱离，键476可以被移开且因此按钮324′可被致动。除了这些修改，此可替换实施例的插入器成套工具300′的功能与前面所述的实施例相同。
在另一实施例中，可以使用与挡块386接合力度较小(lessaggressive)的拨爪，以通过致动器按钮324或324′提供往返装置338更容易和更稳定的释放。可替换地，上述设计可以修改为具有单独的位于更中心位置的往返装置释放拨爪(未示出)，以取代所示的两个外侧拨爪412。
参照图17-图20，示出了包括允许改变传感器插入速度的特征的各种可选实施例。首先参照图17，插入器500的实施例具有如图所示的千分尺样式的头部或旋钮502，其布置方式与上面描述的插入器实施例相似。旋钮502可以连接至螺杆504。螺杆504可以穿过固定的壳体横向件506中的螺纹孔或插入孔(insert)。螺杆504 的远端可旋转地或固定地连接至压缩件508。压缩件508可以相对于运送器或往返装置510移动以在其间压缩驱动弹簧512。
往返装置510可以设置有有倒钩拨爪514，用于接合壳体518内的挡块516以便可释放地将往返装置510保持在竖起位置中，其布置与前面描述的实施例相似。插入器500可以设置具有致动器按钮(例如图1所示的324)，用于将有倒钩拨爪514从挡块516释放(也如前所述)，从而允许驱动弹簧512驱动往返装置510带着导入器利刃和/或传感器520下降而插入患者皮肤中。还可以提供回位弹簧522以在传感器插入后使往返装置510收回进壳体518中。
根据本发明的各方面，传感器插入的驱动力、运动距离、速度、加速度和/或其他特性均可以进行调整。在该实施例中，使用者可以转动旋钮502使得螺杆504在壳体横向件506中的螺纹孔或插入孔中旋转。在一个方向上转动旋钮502使得旋钮502、螺杆504和压缩件508向下移动，从而进一步顶着往返装置510压缩驱动弹簧512。在相反方向上转动旋钮502，减轻了对驱动弹簧512的压缩。通过在发射插入器500前转动旋钮502，使用者可以增大或减小插入速度和/或其他传感器插入特性。
旋钮502、螺杆504和/或壳体518可以设置数字、线条、指针或其他标记以帮助使用者将旋钮502设置到期望的位置中。在该特定实施例中，使用者可以在竖起插入器500之前调整旋钮502以减少转动旋钮502所需的力量，这是因为驱动弹簧512可能未被压缩或如在未竖起状态时那样压缩。可替换地，可以在插入器500已被竖起后转动旋钮502。这种方案可以在调整期间向使用者提供反馈，因为插入器500可以设计为：当驱动弹簧512进一步被压缩时，允许使用者在转动旋钮502时感觉到更大的阻力。应该提到的是，在该实施例中，允许使用者可变地调整插入特性，如通过转动旋钮502经过一定范围的位置而在一定速度范围内调整插入速度。在一个实 施例中，向使用者提供的是旋钮502设置在一个范围的中间的插入器500，因此使用者可以增加或减少插入速度，或将其保留在默认设置值处。
在可选实施例(未示出)中，其为图17所示实施例的一种变型，其中旋钮502可以被设置成使其在自由转动时保持在固定位置。在该实施例中，螺纹孔或插入孔可以设置在旋钮502或压缩板508中，而螺杆504可以固定连接至另一个上。这种布置可以以类似于图17所示的实施例的方式进行操作，并且允许去除固定的壳体横向件506。
在另一可替换实施例(未示出)中，其为图17所示的实施例的另一变型，其中旋钮502、螺杆504和压缩件508可以由壳体盖(housing cap)代替，该壳体盖与主壳体诸如通过螺纹联接旋转地接合。驱动弹簧可以介于壳体盖与往返装置510之间。当拧动壳体盖使其与主壳体进一步接合时，驱动弹簧进一步被压缩。反过来，壳体盖可以从主壳体旋回以减少驱动弹簧的压缩。如前所述，驱动弹簧的压缩设置值可以影响传感器插入特性，如传感器传送速度。
现在参照图18A和18B，其中示出了另一可选插入器600的实施例。插入器600可以包括拇指轮602。拇指轮602可以如所示的从壳体604突出以使得使用者易于转动它来调整传感器插入的(多个)参数。拇指轮602可以直接驱动螺杆606，或通过可旋转地接合小齿轮608间接驱动它。小齿轮608或压缩件610可以包括用于容纳螺杆606的螺纹孔或插入孔。通过这种布置，拇指轮602的旋转使得螺杆606降低或升高压缩板610，由此进一步相应地压缩或解压驱动弹簧612。拇指轮602和/或壳体604可以设置数字、线条、指针或其他标记以帮助使用者将拇指轮602设置在期望的位置中。壳体604顶部可以设置有窗口以允许观察拇指轮602上的一个或多 个标记。在所有其他方面，图18A和18B所示的插入器600可以以与图17所示的插入器500相似的方式进行操作。
现在参照图19A和19B，其中示出了另一可选插入器700的实施例。插入器700包括往返装置702，该往返装置可以被旋转以影响驱动弹簧704的压缩。如图19A所示，有倒钩拨爪706可以与第一对挡块708相接合以将往返装置702保持在第一高度上的竖起位置中。如图19B所示，插入器700可以设置有第二对挡块710。第二对挡块710可以位于壳体712内比第一高度低的第二高度上。插入器可以具有允许往返装置702旋转90度的构造，使得当往返装置702被竖起时有倒钩拨爪706可以与第一对挡块708接合或者与第二对挡块710接合。在本实施例中，当有倒钩拨爪706与较高的第一对挡块708接合时，如图19A和19B所示，驱动弹簧704比有倒钩拨爪706与较低的第二对挡块710接合时压缩得多些，当插入器700被致动时这可以导致较高的传感器速度。应该注意的是，与前面所述实施例提供连续变化范围的设置值相对，本实施例可以向使用者提供独立的离散调整设置值。
在可选实施例(未示出)中，可以设置多于两对的挡块以提供额外的驱动弹簧压缩位置。这种布置可以使用方形、圆形或其他形状的壳体。在其他实施例中，可以在壳体712上设置一对挡块708，而在往返装置702的不同高度上可以有多对有倒钩拨爪706，以替换地与这对挡块708相接合。可替换地或与该实施例相结合，(多个)挡块708可以位于往返装置702上，而(多个)有倒钩拨爪706可以位于壳体712上。对本领域的技术人员来说，在不背离本发明范围的基础上可能想到这些实施例的其他修改。
现在参照图20A和20B，其中示出了另一可选插入器800的实施例。插入器800包括至少一个磁体802，该磁体可以影响驱动弹簧804的压缩。驱动弹簧804可以位于往返装置806与壳体810的 顶部808之间。往返装置806可以包括含铁金属材料和/或一个或多个磁体(未示出)，用于将往返装置806吸附至磁体802。磁体802可以位于往返装置806上方枢转臂812上，该枢转臂可围绕铰链814枢转。在该实施例中，磁体802与往返装置806之间的磁引力压缩驱动弹簧804并将往返装置806保持在竖起位置中。按下发射翼片816使得臂812围绕铰链814沿图示箭头A方向枢转，并将磁体802抬高而离开往返装置806。磁体802与往返装置806之间间隙的增大导致它们之间的磁引力减小直至压缩的驱动弹簧804的力超过磁引力的力。此时，驱动弹簧804可以延伸，从而将传感器818发射至使用者皮肤内。
往返装置806与(多个)磁体802之间的磁引力的大小可以通过(多个)802磁体的尺寸、数量、位置和/或极性来改变。例如，使用者可以将附加的磁体802放在枢轴臂812顶上以进一步压缩驱动弹簧804。这进而可以提供更高的传感器插入速度。在可选实施例中，(多个)磁体可以与前面所述的实施例结合在一起使用以影响弹簧的压缩。在这些实施例中，无磁体可以用于低速设置，而一个或多个磁体可以用于(多个)较高的速度设置。
在其他实施例中(未示出)，使用者可以替换安装单独的套管(cartridge)，每个套管具有不同的弹簧比率，以用于提供不同的插入特性。可替换地，可使用发条型恒力弹簧来改变弹簧力。这样的布置也可以使用棘齿和锁型机械来影响绕组(winding)。在又一实施例中，可以使用内部阻尼器或其他特性以允许调整插入器的发射特性。例如，可以采用气囊(air bladder)、可移动壁或接触区域以增加、减少或消除摩擦，从而使得传感器往返装置速度产生变化。
在上述实施例中，驱动传感器或其他物体进入体内的一个或多个力可以来自压缩弹簧、拉伸弹簧、扭转弹簧、气压或液压缸或气 囊、磁体、电磁体或其他本领域技术人员已知的用于储存势能的原动机或设备。
在上述实施例中，整个插入设备或其部件均可丢弃或重复利用。
对于与本发明相关的其他细节，可根据相关领域技术人员的水平范围来使用材料和制造技术。在普遍地或逻辑上采用的其他行为方面，关于本发明的基于方法的方面同样可以适用。此外，可以预期的是，所描述的发明变型的任何可选特征均可以独立地或者与这里所描述的任何一个或多个特征相结合地阐述并要求保护。同样地，参照单个项(item)，包括了存在多个相同项的可能性。更具体地，如在此处以及所附权利要求中所使用的，单数形式的“一个”、“和”、“所述”以及“该”包括多个所指物，除非上下文有明确指定。应进一步注意的是，权利要求可能撰写为排除了任何可选的要素。同样地，这种表述目的在于用作在先引用基础，以使用这种排他性术语，例如，与权利要求要素的叙述有关的“单独地”、“仅”等，或使用“否定的”限定。除非这里有另外的限定，否则，这里所使用的所有技术术语以及科学术语均具有本发明所属领域的普通技术人员公知的相同含义。本发明的范围并不受本说明书主题的限制，而是仅由所采用的权利要求的明确含义所限定。

Claims (20)

1.一种传感器插入设备，包括：
壳体；
往返装置，能够在所述壳体中的第一位置与所述壳体中的第二位置之间移动，所述往返装置被构造为当处于所述第一位置中时保持经皮传感器而当处于所述第二位置中时释放所述传感器；
结合至所述往返装置的驱动机构，将所述往返装置从所述壳体中的所述第一位置驱动至所述壳体中的所述第二位置；
收缩机构，被构造成当所述往返装置已经释放所述传感器时自动地将所述往返装置收缩到第三位置，从而当处于所述第三位置时，所述往返装置被完全包含在所述壳体中；以及
控制机构，其可操作地结合至所述驱动机构，其中，使用者能够手动调节所述控制机构，所述控制机构被构造成，在所述往返装置处于所述第一位置或所述第三位置时，改变所述驱动机构的驱动力。
2.根据权利要求1所述的插入设备，其中，用于改变所述驱动力的装置可由所述插入设备的使用者操作。
3.根据权利要求1所述的插入设备，其中，能够被手动调节的所述控制机构被构造成在具有连续变化范围的设置值内改变所述驱动力。
4.根据权利要求1所述的插入设备，其中，能够被手动调节的所述控制机构被构造成将所述驱动力可替换地设定为多个离散设置值中的一个。
5.根据权利要求1所述的插入设备，其中，能够被手动调节的所述控制机构包括旋钮，所述旋钮被构造为由所述插入设备的所述使用者扭转。
6.根据权利要求1所述的插入设备，其中，能够被手动调节的所述控制机构包括拇指轮，所述拇指轮被构造为由所述插入设备的所述使用者转动。
7.根据权利要求1所述的插入设备，其中，能够被手动调节的所述控制机构包括这样的一个部件，所述部件被构造为由所述插入设备的所述使用者设定成多个离散、交替方向中的一个方向。
8.根据权利要求7所述的插入设备，其中，所述部件包括所述往返装置。
9.根据权利要求1所述的插入设备，其中，能够被手动调节的所述控制机构包括磁体。
10.根据权利要求1所述的插入设备，其中，能够被手动调节的所述控制机构包括螺杆。
11.根据权利要求1所述的插入设备，其中，驱动机构包括压缩弹簧。
12.根据权利要求1所述的插入设备，其中，能够手动调节的所述控制机构被构造成使得所述插入设备的使用者能够设定所述传感器插入速度。
13.根据权利要求1所述的插入设备，其中，能够手动调节的所述控制机构使得所述使用者能够手动改变所述驱动机构的偏置弹簧的压缩量。
14.一种传感器插入设备，包括：
传感器导入器，其可操作地结合至驱动机构，其中，所述驱动机构被构造成使得所述传感器导入器从第一位置移动至第二位置，并且其中，所述传感器导入器被构造成，当处于所述第一位置时保持传感器的至少一部分，当处于所述第二位置时，释放所述传感器的所述至少一部分；
收缩机构，其被构造成，当所述传感器的所述至少一部分已经从所述传感器导入器被释放时，自动地将所述传感器导入器从所述第二位置移动至第三位置；以及
控制机构，其可操作地结合至所述驱动机构，其中，所述控制机构被构造为，当所述传感器导入器处于所述第一位置或所述第三位置时，允许使用者手动调节所述插入设备的至少一个的传感器插入特性。
15.根据权利要求14所述的插入设备，其中，所述至少一个传感器插入特性选自包括以下特性的组：所述驱动机构的驱动力、所述驱动机构的速度、所述驱动机构的行进距离、或所述驱动机构的加速度。
16.根据权利要求14所述的插入设备，其中，所述至少一个传感器插入特性包括具有连续变化范围的设置值。
17.根据权利要求14所述的插入设备，其中，所述至少一个传感器插入特性包括离散的设置值。
18.根据权利要求14所述的插入设备，其中，所述控制机构使得所述使用者能够手动改变所述驱动机构的偏置弹簧的压缩量。
19.根据权利要求14所述的插入设备，其中，所述控制机构包括旋钮，所述旋钮被构造为由所述插入设备的所述使用者扭转。
20.根据权利要求14所述的插入设备，其中，所述控制机构包括拇指轮，所述拇指轮被构造为由所述插入设备的所述使用者转动。
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