CN101631586B - 药物输注和分析物监测的模块化组合 - Google Patents
药物输注和分析物监测的模块化组合 Download PDFInfo
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- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
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- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
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- A—HUMAN NECESSITIES
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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Abstract
本发明提供了用于提供集成输液装置和分析物监测系统中的模块化部件的方法和系统,其中,部件是可独立更换的。
Description
优先权
本申请要求根据美国专利法第35章第119条(e)款于2007年2月19日提交的名称为“药物输注和分析物监测的模块化组合”的美国临时专利申请no.60/890,497以及2008年2月15日提交的名称为“药物输注和分析物监测的模块化组合”的美国专利申请no.12/032,593的优先权,二者的内容结合于此以供参考。
技术领域
本发明涉及用于集成输液系统和分析物监测系统的方法和系统。更具体地,本发明涉及用于提供集成输液和分析物监测系统的模块化组合的方法和系统。
背景技术
必须周期性地给I型糖尿病患者提供胰岛素以维持其生理条件。通常,例如,在进餐前和/或在每天的适当时间(例如,在利用指尖检测方式进行血糖水平测试的同时),利用针型注射器给这些患者注射一定剂量的速效或慢效胰岛素。如果未适当提供胰岛素,糖尿病患者的身体会面临遭受严重(如果不是致命的)损伤的风险。
近年来,除了别的因素以外,由于通过更好地调节和控制胰岛素的摄取改善了对糖尿病的管理,外部输液泵治疗的持续开发和改善已备受糖尿病患者的关注。通常,患者插入插管(其连接于输液管,而输液管又连接于外部泵),然后基于预编程的基础方式(basalprofile)输注胰岛素。此外,例如,为与执行患者基础方式的输液装置一起使用,目前可获得的外部输液装置包括计算性能以确定适宜的推注剂量(bolus dose),例如,碳水化合物推注(carbohydratebolus)和矫正推注(correction bolus)。
基础方式通常由患者的医师或护理人员确定,并且其基于许多因素(包括由例如患者的医师所诊断的患者的胰岛素敏感性以及生理条件)而确定,而且通常用来准确地评估在患者输注胰岛素过程的预定期间内患者的葡萄糖水平。葡萄糖水平可以基于患者的周期性不连续检测来评估,该检测利用测试条以及血糖仪(例如,可从加利福尼亚的阿拉米达的雅培糖尿病护理公司(Abbott DiabetesCare,Inc.,)获得的自由型葡萄糖仪(FreestyleGlucose Meter))。然而,这样的评估易出错误,并且不能准确地反映患者实际的生理条件。
此外,输液和分析物监测的每个方面都需要被构造为执行涉及诸如胰岛素输送和分析物监测的控制和管理的相关功能的部件。另外,这些部件容易失效,或者由于正常使用而被定期更换。鉴于上述内容,希望具有一种包括药物输送单元(例如,胰岛素泵)和分析物监测装置(例如,连续血糖监测系统)的模块化系统,该系统允许当整个治疗管理系统的一个或多个方面失效或需要更换时基于部件进行更换。
发明内容
根据本发明的各个实施例,提供了用于药物输送和生理条件监测的模块化组合的方法和系统。
根据以下对多个实施例、所附权利要求以及附图的详细描述,本发明的这些和其他目的、特征以及优点将变得充分显而易见。
附图说明
图1示出了根据本发明一个实施例的集成输液装置和分析物监测系统;
图2示出了根据本发明另一实施例的集成输液装置和分析物监测系统;
图3示出了根据本发明又一实施例的集成输液装置和分析物监测系统;
图4示出了根据本发明又一实施例的集成输液装置和分析物监测系统;
图5示出了根据本发明又一实施例的集成输液装置和分析物监测系统;
图6示出了根据本发明又一实施例的集成输液装置和分析物监测系统;
图7A更详细地示出了图6所示的在本发明一个实施例中的集成输液装置和监测系统,而图7B至图7C分别示出了图7A所示的根据本发明一个实施例的集成输液装置和监测系统的位于患者界面处的模拟前置电路以及泵组件;
图8A至8C分别示出了连续分析物监测系统中使用的无源传感器构造,以及在根据本发明一个实施例的集成输液装置和监测系统的患者界面处使用的有源传感器构造的两个实施例;
图9示出了根据本发明一个实施例的集成输液装置和分析物监测系统,其中,输液装置和监测系统发送器结合到患者戴用的单个贴剂中;
图10是根据本发明一个实施例的结合有分析物监测系统传感器电极的输液装置插管的详细视图;
图11A示出了根据本发明另一实施例的结合有分析物监测系统传感器电极的输液装置插管的部件透视图,而图11B示出了根据本发明一个实施例的结合有输液装置的分析物监测系统发送器单元的俯视平面图;
图12A至12C分别示出了根据本发明不同实施例的结合有图10的连续分析物监测系统传感器电极的输液装置插管的横截面图;
图13是定时图,用于说明在一个实施例中由集成输液装置和监测系统进行的血糖测量和胰岛素输送的时间间隔;
图14A至14C示出了根据一个实施例的药物输送和生理条件监测系统的模块化组合;
图15A至15C示出了根据另一实施例的药物输送和生理条件监测系统的模块化组合;
图16示出了根据一个实施例的模块化传感器部件的俯视平面图;以及
图17示出了根据又一实施例的药物输送和生理条件监测系统的模块化组合。
具体实施方式
图1示出了根据本发明一个实施例的集成输液装置和分析物监测系统。参照图1,本发明一个实施例中的集成输液装置和分析物监测系统100包括输液装置110,其连接至用于液体输送或输注的输液管130,并且输液管进一步接合至插管170。如从图1可以看到的,插管170构造为可安装地(mountably)接合至发送器单元150,其中,发送器单元150还可安装地接合至分析物传感器160。还提供了一种分析物监测器单元120,其被构造为通过通信路径140与发送器单元无线通信。
参考图1,在本发明的一个实施例中,发送器单元150构造为用于通过通信路径140向分析物监测器单元120单向无线通信。在一个实施例中,分析物监测器单元120可构造为包括用于通过通信路径140进行双向通信的收发器单元(未图示)。在一个实施例中,发送器单元150可构造为周期性地或连续地向分析物监测器单元120发送与由分析物传感器160检测到的分析物水平有关的信号。分析物监测器单元120可构造为接收来自发送器单元150的信号,而在一个实施例中,分析物监测器单元120构造为进行数据存储并基于一个或多个预编程的或预定的程序进行数据处理。
例如,在一个实施例中,分析物监测器单元120被构造为将接收到的与分析物水平有关的信号存储在数据存储单元(未图示)中。可替换地,或此外,分析物监测器单元120可被构造为处理与分析物水平有关的信号,从而例如通过线图的可视显示或基于角图标的显示产生用于在其显示单元121上输出显示的趋势显示。另外的信息可以输出显示在分析物监测器单元120的显示单元121上,该信息包括(但不限于)基本上同时且实时监测的患者的分析物水平,该信息由传感器160所检测并接受自发送器单元150。实时监测的分析物水平可以数字形式或以向患者提供由传感器160所检测的基本上实时的分析物水平的准确测量结果的任何其他适当形式显示。
可由传感器160监测或测定的分析物包括诸如乙酰胆碱、淀粉酶、胆红素、胆固醇、绒毛膜促性腺激素、肌酸激酶(例如,CK-MB)、肌酸、DNA、果糖胺、葡萄糖、谷氨酸盐、生长激素、激素、酮、乳酸盐、过氧化物、前列腺特异抗原、凝血素、RNA、促甲状腺激素,以及肌钙蛋白。也可以测定药物(drug)的浓度,诸如,如抗生素(例如,艮他霉素、万古霉素等等)、洋地黄毒苷、地高辛、药物滥用、茶碱,以及华法令阻凝剂(warfarin)。
回到图1,传感器160可以包括短期(例如,使用期为3天、5天或7天)分析物传感器,其在预期的使用寿命之后被更换。此外,在一个实施例中,传感器160被构造为定位在患者皮肤下面,使得至少部分分析物传感器保持与患者的分析物(例如,间质液(interstitial fluid)或血液)液体接触。此外,被构造为类似地定位在患者皮肤下面的插管170连接于输液装置110的输液管130,以便向患者输送诸如胰岛素的药物。此外,在一个实施例中,插管170被构造为在更换传感器160时被更换。
在本发明的一个方面,插管170和传感器160可被构造为利用诸如插入式注射器(insertion gun)的插入机构(未图示)定位在患者皮肤下面,该插入式注射器可包括例如弹簧偏压或加载的插入机构,以将插管170和传感器160基本上准确地定位在患者皮肤下面。以这种方式,插管170和传感器160可以皮下定位而患者几乎不会或不会感到疼痛。可替换地,插管170和/或传感器160可构造为由患者用手插入自己的皮肤。在定位插管170和传感器160以后,它们可以通过粘合层180基本上牢固地保持在适当位置,该粘合层被构造为在传感器160和插管170皮下定位期间持续粘附于患者的皮肤。
此外,在一个实施例中,可以在皮下定位传感器160和插管170之后安装发送器单元150,以使发送器单元与传感器电极电接触。类似地,输液管130可被构造为可操作地接合于发送器单元150的外壳,以便准确定位从而对准插管170,并提供基本上防水的密封。例如,美国专利第6,134,461号、第6,175,752号、第6,121,611号、第6,560,471号、第6,746,582号等中描述了可使用的示例性分析物系统。
回到图1,输液装置110可包括:编程基础方式;计算推注剂量的性能,其包括但不限于矫正推注、碳水化合物推注、追加推注(extended bolus),以及双推注(dual bolus),其可由患者利用输液装置110来操作,并且可基于一种或多种因素,这些因素包括患者的胰岛素敏感性、伙食中的胰岛素(insulin on board)、预期碳水化合物摄取量(例如,用于进餐前的碳水化合物推注计算)、患者的测量的或检测到的葡萄糖水平以及患者的葡萄糖趋势信息。在另一实施例中,推注计算性能也可设置在分析物监测器单元120中。
在一个实施例中,分析物监测器单元120被构造为具有可由患者容易地携带的基本上紧凑的外壳。此外,输液装置110类似地可被构造为基本上紧凑的装置,其可容易且方便地戴在患者的衣服上(例如,装在佩戴或夹于患者的皮带或衣服的其他部分上的皮套(holster)或承载装置中)。再次参照图1,分析物监测器单元120和/或输液装置110可包括诸如由患者操作的信息输入机构的用户界面以及数据输出,数据输出包括诸如分析物监测器单元120上的显示单元121,或类似地包括诸如输液装置110上的显示单元111。
可将一种或多种音频输出装置(例如,扬声器或蜂鸣器)与输液装置110和/或分析物监测器单元120的外壳结合,以便基于与输液装置110或分析物监测器单元120有关的一种或多种预定状态的发生输出声音警报或报警。例如,输液装置110可构造成当检测到输液管130的阻塞或发生诸如更换插管170时提示准备好(prime)输液管的定时事件(timed event)时,向患者输出声音警报或报警。
分析物监测器单元120可类似地被构造为当预定状态或预编程事件发生时输出声音警报或报警,如,提示更换已过使用期(如,3天、5天或7天,或更多天)的传感器160,或与从发送器单元150接收到的对应于患者的监测到的分析物水平的数据有关的一种或多种警报。这样的警报或报警可以包括向患者发出的报警:检测到的分析物水平超过预定阈值水平,或在给定时间内检测到的分析物水平的趋势预示重要的状态,例如,潜在的高血糖症或低血糖症,需要注意或进行矫正。值得注意的是,以上描述的声音警报和/或报警的实例仅用于说明的目的,在本发明的范围内,可以将其他事件或状态编程到输液装置110或分析物监测器单元120或此两者中,以便向患者报警或通知此类事件或状态的发生或潜在发生。
此外,在本发明的范围内,可以单独输出声音报警,或与一种或多种可视警报一起输出,可视警报例如分别在输液装置110或分析物监测器单元120的显示单元111、121上的输出显示,或能向与报警和/或警报关联的患者提供触觉指示的振动报警。
此外,再次参照图1,虽然示出了一个分析物监测器单元120和一个发送器单元150,在本发明的范围内,可以提供另外的多个分析物监测器单元或发送器单元,以使例如发送器单元150可被构造为基本上同时向多个分析物监测器单元传输信息。可替换地,可构造接合至同时与患者的分析物液体接触的多个传感器的多个发送器单元以向分析物监测器单元120或者多个分析物监测器单元传输信息。例如,可在集成输液装置和分析物监测系统100中设置接合于附加传感器的附加发送器单元,该集成输液装置和分析物监测系统并不包括插管170,并且可用来执行诸如传感器校准、传感器数据验证等与传感器160有关的功能。
在一个实施例中,发送器单元150被构造为传输接收自传感器160的采样数据信号,而没有来自分析物监测器单元120的传输的采样数据信号已接收到的确认。例如,发送器单元150可被构造为在完成初始开机(power on)程序后以固定速率(例如,以1分钟的间隔,或任何适当的速率)传输编码采样数据信号。同样,分析物监测器单元120可被构造为在预定时间间隔检测上述传输的编码采样数据信号。可替换地,发送器单元150和分析物监测器单元120可被构造为通过通信路径140进行双向通信。
另外,一方面,分析物监测器单元120可包括两部分。分析物监测器单元120的第一部分可包括模拟界面部分(analog interfacesection),其被构造为借助通信路径140与发送器单元150进行通信。在一个实施例中,该模拟界面部分可包括用于接收和放大来自发送器单元150的数据信号的天线和RF接收器,之后,用本机振荡器对这些信号进行解调并通过带通滤波器进行过滤。分析物监测器单元120的第二部分可包括数据处理部,其被构造为诸如通过执行数据解码、错误检测和修正、数据时钟生成(data clock generation),以及数据位恢复来处理从发送器单元150接收到的数据信号。
在操作中,在完成开机程序以后,分析物监测器单元120被构造为基于诸如接收自发送器单元150的检测到的数据信号的强度或预定的发送器识别信息在其范围内检测发送器单元150的存在。在与发送器单元150成功同步以后,分析物监测器单元120被构造为开始接收来自发送器单元150的对应于患者的所检测的分析物(例如,葡萄糖水平)的数据信号。
再次参照图1,分析物监测器单元120或输液装置110或两者可被构造为进一步与数据处理终端(未图示)进行通信,该数据处理终端可包括台式计算机终端、可以进行数据通信的信息站(kiosk)、膝上型计算机、诸如个人数字助理(PDA)的手提式计算装置,或可以进行数据通信的移动电话等等,其每一种都可被构造为借助有线或无线连接进行数据通信。数据处理终端例如可包括在医院环境中的医师终端和/或床边终端。
用于图1中的发送器单元150和分析物监测器单元120之间的数据通信的通信路径140可包括在两个或多个电子装置之间的RF通信链路、蓝牙通信链路、红外线通信链路或任何其他类型的适宜的无线通信连接。数据通信链路还可以包括有线电缆连接,例如但不限于RS232连接、USB连接或串行电缆连接。
再一次参照图1,在本发明的另一方面,分析物监测器单元120或输液装置110(或两者)还可包括测试条口,构造该测试条口以容纳用于不连续地采样患者的血液以进行葡萄糖水平测定的血糖测试条。血糖测试条仪单元的功能的一个实例可以参见可从本发明的受让人(assignee)雅培糖尿病护理公司处获得的自由型血糖仪(FreestyleBlood Glucose Meter)。
以上述方式,在本发明的一个实施例中,用于输注胰岛素或其它适宜药物的插管170与用于分析物监测系统的传感器160和发送器单元150的粘附贴剂180结合。因此,患者可以仅戴用一个皮肤上贴剂(例如,在腹部的皮肤上)而不是戴用用于输液装置插管170以及分析物监测系统传感器160(具有发送器单元150)的两个贴剂。因此,I型糖尿病患者可以结合实时葡萄糖监测方便地实施输注治疗,同时将对粘附贴剂180部位处的患者皮肤的潜在皮肤刺激降低到最小程度,因而提供更多的较少刺激的插入部位。
此外,如图1所示的集成输液装置和分析物监测系统100可被构造为使输液管130可与输液装置110以及与发送器单元150(或粘附贴剂180)的外壳分开,从而,可选地,患者可以将系统构造为连续分析物监测系统,同时中止输液装置110的功能。同样,患者可以将系统构造为输液装置同时中止连续分析物监测系统的功能。
此外,根据本发明的一个实施例,通过具有基本上连续的实时葡萄糖数据、基于基本上连续的实时葡萄糖数据的趋势信息,患者可以更好地管理与糖尿病有关的生理状态,因此,根据预编程的基础方式(输液装置110被构造为实施该基础方式)来改善或调节由输液装置110输送的输液水平。
图2示出了根据本发明的另一实施例的集成输液装置和分析物监测系统。参照图2,在本发明一个实施例中的集成输液装置和分析物监测系统200包括集成输液装置和分析物监测器单元210,其接合至输液管220,而输液管220连接于插管260。图2中还示出了发送器单元240,其与分析物传感器250电接触,其中,插管260和分析物传感器250皮下定位于患者皮肤的下面,并且通过粘合层或贴剂270保持在适当位置。
参照图2,集成输液装置和分析物监测器单元210被构造为通过通信路径230(如RF通信链路)与发送器单元240无线通信。与图1所示的实施例相比,可以看出,在图2所示的实施例中,输液装置和分析物监测器被结合到一个外壳210中。以这种方式,发送器单元240可被构造为将接收自分析物传感器250的对应于检测的分析物水平的信号传输到集成输液装置和分析物监测器单元210,用于数据分析和处理。
因此,患者可以方便地接收来自发送器单元240的实时葡萄糖水平,从而决定是否改变现有的基础方式,并据此向患者输送胰岛素。以这种方式,分析物监测器单元的功能可以结合到输液装置的紧凑外壳内,以向患者提供另外的方便,例如,通过向输液装置的用户界面提供实时葡萄糖数据以及诸如葡萄糖趋势数据的其它有关信息,使得患者可容易地确定对胰岛素泵的输注速率的任何适宜的改变。
在一个实施例中,图2示出的每个部件的构造包括插管260、分析物传感器250、发送器单元240、粘合层270、通信路径230、以及输液管220,并且输液装置和分析物监测器的功能基本上类似于以上结合图1描述的各个相应的部件。
因此,在本发明的一个实施例中,例如,通过设置一个集成装置,在保持和增强糖尿病管理方面可以向患者提供另外的方便,该集成装置如集成输液装置和分析物监测器单元210,其能够允许患者利用集成输液装置和分析物监测器单元210的单个用户界面系统来容易地操作和管理胰岛素治疗。确实,通过在一个装置中提供与葡萄糖水平以及胰岛素输注有关的信息,可以向患者提供在管理糖尿病和改善胰岛素治疗方面另外的方便。
图3示出了根据本发明又一实施例的集成输液装置和分析物监测系统。参照图3,在本发明的一个实施例中,集成输液装置和分析物监测系统300包括输液装置310,其连接于输液管340,而输液管340又接合至插管370。插管370被构造为皮下定位在患者皮肤的下面并通过粘合层380基本上保持在适当位置。如上所述以及类似于结合图1-2所描述的实施例,同样保持在适当位置的还有分析物传感器360,其同样皮下定位在患者皮肤下面并保持与患者的分析物液体接触。提供发送器单元350以便与分析物传感器360的电极电连接。同样,如从图3可以看到的,在一个实施例中,输液管340连接至发送器单元350的外壳以便连接至布置在患者皮肤下面的插管370。
参照图3,还提供了分析物监测器单元320,其被构造为与发送器单元350无线通信,以接收来自发送器单元的由分析物传感器360检测到的与患者的分析物水平有关的数据。参照图3,在一个实施例中,输液装置310并不包括诸如显示单元和/或输入单元(如按钮或微动转盘)的用户界面。相反,用户界面和控制机构设置在分析物监测单元320上,使得分析物监测单元320被构造为无线控制输液装置310的操作,并进一步适当地编程输液装置310以执行预编程基础方式,并控制输液装置310的功能。
更具体地说,所有用于输液装置310的编程和控制机构都设置在分析物监测单元320中,使得当患者戴用输液装置310时,其可以小心地戴用在衣服下靠近患者皮肤上的输注部位(如腹部),同时患者仍然可以通过分析物监测单元320来方便地控制输液装置310。
此外,在一个实施例中,图3所示的每个部件的构造包括插管370、分析物传感器360、发送器单元350、粘合层380、通信路径320以及输液管340,并且输液装置和分析物监测单元320的功能基本上类似于如上结合图1描述的各个相应的部件。然而,在图3所示的实施例中,输液装置310被构造为通过收发器或等效通信机构与分析物监测单元320通信。
以这种方式,在本发明的一个实施例中,输液装置310的构造(没有用户界面)提供了更小且更轻的外壳以及用于输液装置310的结构,其将增强患者戴用和/或携带输液装置310时的舒适感。此外,由于在分析物监测单元320上设置了输液装置310的控制和编程功能,所以患者可以方便地编程和/或控制输液装置310的功能和操作,而不用局限于附接于定位在患者皮肤下面的插管370的输液管340。此外,由于在分析物监测单元320上远程进行输液装置310的编程和控制,所以输液管304可以更短并因此更方便。
图4示出了根据本发明又一实施例的集成输液装置和分析物监测系统。参照图4,在本发明一个实施例中,集成输液装置和分析物监测系统400包括输液装置410,其被构造为通过诸如RF(无线电频率)链路的通信路径430与分析物监测单元420无线通信。此外,如从图4可以进一步看到的,输液装置410连接于输液管440,输液管内设置有连接于分析物传感器电极的集成导线。如下文更详细描述的,输液装置410借助输液管440接收患者的测得的分析物水平并将其传输到分析物监测单元420,用于进一步处理和分析。
更具体地说,参照图4,集成输液装置和分析物监测系统400包括设置有插管470和分析物传感器460的贴剂450。插管470被构造为将来自输液装置410的药物(例如胰岛素)输送或输注给患者。即,在一个实施例中,插管470和分析物传感器460被构造为皮下定位于患者的皮肤。分析物传感器460被构造为定位成与患者的分析物液体接触。
以这种方式,分析物传感器460与设置在输液管440内的集成导线电接合,以便向输液装置410提供对应于患者的测得的或检测到的分析物水平的信号。在一个实施例中,输液装置410被构造为执行数据分析和存储,以使输液装置410可被构造为在显示单元411上向患者显示实时测得的葡萄糖水平。此外或可替换地,输液装置410被构造为将从分析物传感器460接收到的信号无线传输到分析物监测单元420,用于数据分析、显示、和/或存储,并且分析物监测单元420可被构造为远程控制输液装置410的功能和特点,从而提供另外的用户方便和不连续性。
回到图4,在一个实施例中,贴剂450可被构造为基本小型且其上没有安装发送器单元,并且提供相对小的附着于患者皮肤的表面积。以这种方式,可向患者提供另外的方便之处:将基本紧凑的外壳安置在皮肤上(例如,用粘合层进行附着)来输注诸如胰岛素的药物,并借助分析物传感器460进行连续分析物监测。
图5示出了根据本发明又一实施例的集成输液装置和分析物监测系统。与图4所示的实施例相比,图5的集成输液装置和分析物监测系统500包括集成输液装置和分析物监测单元510。因此,向用户提供了一个用户界面,其包括设置在集成输液装置和分析物监测单元510的外壳上的显示单元511和输入按钮512。在图5中示出的还有输液管520,其内设置有集成导线并连接于与患者的分析物液体接触的分析物传感器540电极。此外,如从图5可以看到的,提供粘附贴剂530以将插管550和分析物传感器540的皮下位置保持在患者皮肤下面的所希望的位置。
可选地,集成输液装置和分析物监测单元510可以具备无线或有线通信功能,以便通过无线通信路径(例如,RF通信链路)、或通过电缆连接(例如,USB连接)与远程终端(例如,医师的计算机终端)通信。回到图5,在本发明的一个实施例中,向使用输注治疗的糖尿病患者提供较少的要处理或操作的部件进一步简化了胰岛素治疗和葡萄糖水平监测和管理。
图6示出了根据本发明又一实施例的集成输液装置和监测系统。参照图6,集成输液装置和分析物监测系统600设置有没有用户界面的输液装置,并且被构造为通过通信路径630(例如,RF链路)与分析物监测单元620无线通信。输液装置610(其可以设置在紧凑外壳中,因为它并不包括与用户界面有关的部件)连接于输液管640,在输液管640中放置有集成导线,而这些集成导线相应地连接于与患者的分析物液体接触的分析物传感器660的电极。此外,在一个实施例中,紧凑粘附贴剂650被构造为将插管670和分析物传感器660保持在患者皮肤下面的所希望的位置。
类似于图3所示的实施例,分析物监测单元620被构造为通过通信链路630来控制和编程输液装置610。以这种方式,通过分析物监测单元620可以远程进行输液装置610的控制和编程功能,从而为患者提供方便。
图7A更详细地示出了图6所示的在本发明的一个实施例中的集成输液装置和监测系统,而图7B至图7C分别示出了图7A所示的根据本发明一个实施例的集成输液装置和监测系统的位于患者界面处的模拟前置电路以及泵组件。参照图7A,其示出了输液装置710,输液装置710连接于输液管720,输液管内设置有用于连接至分析物传感器的电极的集成导线。输液管720进一步连接至粘附贴剂730,粘附贴剂被构造为将插管750和分析物传感器740保持在患者皮肤下面的所希望的皮下位置。
参照图7A,在本发明的一个实施例中,输液装置710可以设置有第一模拟前置电路单元711,而粘附贴剂可以设置有第二模拟前置电路单元731。连接至分析物传感器740的集成导线被构造为从输液装置710经过输液管720延伸到粘合层730。由于在一个实施例中,分析物传感器740是无源部件,鉴于电极的高阻抗以及集成导线的长度(超过几个厘米),在分析物传感器的工作电极和参考电极上的信号易受噪声的影响。噪声进一步可能潜在不利地影响工作电极和参考电极上的信号,这可能使分析物传感器740检测到的分析物水平失真。
鉴于集成导线的长度(其对应于输液管720的长度),在一个实施例中,可以将来自工作电极和参考电极的信号转换成低阻抗信号,以将来自噪声的不利影响降到最低。因此,如下文结合图7B和图7C进一步详细讨论的,输液装置710可设置有第一模拟前置电路单元711,而粘附贴剂730可设置有第二模拟前置电路单元731。
现在参照图7B,在一个实施例中,设置在患者皮肤上的粘附贴剂730上的第二模拟前置电路单元731包括跨阻抗放大器(电流-电压转换器或“I-V”)731A,其被构造为将工作电极(W)电流转换成电压(Vw)并提供保险信号(G);以及伺服段(servo segment)731B,以基于参考电极(R)电压驱动反电极(C)电压(Vc)。图7B还示出了低通滤波器(LPF)和增益段711A,布置在I到V以及伺服段之后,并且在一个实施例中,其构造成驱动A/D(模拟-数字)转换器单元711C,转换器单元的结果由诸如中央处理器(CPU)711D的控制器读取。A/D转换器单元711C和CPU 711D以及其它外围设备可结合到一个称作微控制器(μC)的集成电路(IC)中,例如,MSP430产品系列。
现在参照图7C,在一个实施例中,可以通过一对运算放大器(731A和731B)、四个电阻器(R1、R2、R3、Rf)、以及旁路电容器(Cb)来实施第二模拟前置电路单元731。利用运算放大器731A的I到F阶段是通过来自工作电极(W)的输入电流的作用所产生的,输入电流流过反馈电阻器(Rf)并产生电压差,该电压差由运算放大器731A驱动作为低阻抗信号Vw。由R1、R2以及R3组成的电阻分压器建立了Vw信号的补偿,电阻分压器还产生保险信号(G)的电压,保险信号与工作电极(W)的电位(potentia1)或电压。
在一个实施例中,利用运算放大器731B的伺服系统驱动反电极(C)电压到传感器,以使参考电极(R)处于由电阻分压器(由R1、R2以及R3组成)设置的第二数值。这保持了工作电极(W)电压比参考电极(R)高一设定量,该设定量称作“平衡电压”(即40mV)。旁路电容器(Cb)可以是小的、低等效串联电阻(ESR)电容器,如用来提供局部能量并减小电路上的噪声的0.1uF(100nF)的多层陶瓷(MLC)电容器。用于此电路的电压源可以由V+和V-之间的电位差来提供,例如,V+可以是5V而V-可以是接地(GND),或者V+可以是+3V而V-可以是-3V。
在一个实施例中,运算放大器731A、731B可以是在单个、小8脚、表面安装技术(SMT)封装中的双运算放大器集成电路(IC),例如在SOT23-8封装(3mm×3mm)中的OPA2349。利用诸如“倒装法”和引线接合技术,类似的双运算放大器产品可以在更小的球栅阵列(BGA)封装中获得,并作为可直接安装至电路基板(如印刷电路板(PCB)或柔性电路)的裸芯片。
一方面,上面结合附图描述的分析物传感器可包括设置在基板上的一个或多个工作电极以及一个参考电极或一个参考/反电极,还可选地包括一个单独的反电极。事实上,在一方面,传感器的各个电极以及基板和介电层可设置在堆叠、并排、或分层构造或结构中。例如,在一方面,传感器可包括基板层和第一导电层(例如,设置在基板层的至少一部分上的示踪碳),并且可包括工作电极。还示出了设置在第一导电层的至少一部分上的传感层。
第一绝缘层(例如,第一介电层)可设置或堆叠在第一导电层的至少一部分上,并且,第二导电层(例如,另一示踪碳)可设置或堆叠在第一绝缘层(或介电层)的至少一部分上。第二导电层可包括参考电极,并且在一方面可包括银/氯化银(Ag/AgCl)层。
此外,在一个实施例中,第二绝缘层(例如介电层)可设置或堆叠在第二导电层的至少一部分上。此外,第三导电层(可包括示踪碳并可包括反电极)可设置在第二绝缘层的至少一部分上。最后,第三绝缘层可设置或堆叠在第三导电层的至少一部分上。以这种方式,分析物传感器可被构造为堆叠、并排或分层结构或构造,使得每个导电层的至少一部分被相应的绝缘层(例如介电层)隔开。
另外,在本发明的范围内,分析物传感器的部分或所有电极可以上述的堆叠结构设置在基板的相同侧,或可替代地,可以共面方式设置,从而使每个电极都设置在基板的相同平面上,然而,在导电层/电极之间设置有介电材料或绝缘材料。此外,在又一方面,该一个或多个导电层(例如,传感器的电极)可设置在基板的相对侧。
再次参照附图,图8A至8C分别示出了连续分析物监测系统中使用的无源传感器构造,以及在根据本发明一个实施例的集成输液装置和监测系统的患者界面处使用的有源传感器构造的两个实施例。参照图8A,分析物传感器810包括工作电极811、保护线(guardtrace)812、参考电极813、以及反电极814。在一个实施例中,分析物传感器810的“尾”段815被构造为皮下定位在患者皮肤下面,从而与患者液体接触。
现在参照图8B,分析物传感器820设置有模拟前置部分821,图中示出的根据一个实施例的四个触点是V+、V-、Vw、以及Vc信号,分别代替工作电极811、保护线812、参考电极813、以及反电极814。以这种方式,在本发明的一个实施例中,有源分析物传感器820的这些信号是低阻抗的,因而比无源传感器信号较少受到噪声的影响。此外,在一个实施例中,分析物传感器820的构造可以包括柔性电路。
现在参照图8C,在另一实施例中,示出了一种有源传感器,其具有与图11B的有源传感器820类似的结构但其尺寸更小。更具体地,分析物传感器830设置有四个触点,这些触点被构造用于直接引线接合而不是如先前在图8A至8B中示出的两种传感器构造上的大接触表面所指示的机械接触系统。由于减小了分析物传感器830的形状,传感器830可以缠绕在插管(例如,图4的插管470)上,因而患者的分析物监测和胰岛素输注仅需要一个插入部位。此外,在本发明的范围内,可以提供另外的传感器/插管构造,其中,传感器电路和插管设置为一个组件,例如表面制作有电路831的插管。
图9示出了根据本发明一个实施例的集成输液装置和分析物监测系统,其中,输液装置和监测系统发送器结合到由患者戴用的一个贴剂中。参照图9,集成输液装置和分析物监测系统900包括设置在粘合层960上的集成贴剂泵和发送器单元910,并该粘合层被构造为放置在患者皮肤上,以便将插管950和分析物传感器940牢固地皮下定位在患者皮肤下面。在一个实施例中,集成输液泵和发送器单元910的外壳被构造为包括输注机构,其借助插管950将药物(例如胰岛素)输送给患者。
此外,集成贴剂泵和发送器单元910被构造为通过无线通信路径930(例如RF链路)传输与由分析物传感器940测得的分析物水平有关的信号。这些信号被从身体上的集成贴剂泵和发送器单元910传输到控制单元920,控制单元被构造为控制集成贴剂泵和发送器单元910的操作,并接收来自集成贴剂泵和发送器单元910的传输的信号,该传输的信号对应于检测到的患者的分析物水平。
回到图9,在一个实施例中,集成贴剂泵和发送器单元910的输注机构可包括在美国专利第6,916,159号(授予本发明的受让人,雅培糖尿病护理公司)中描述的输液装置类型。此外,虽然在图9中示出了通过通信路径930的无线通信,但可以用一组导线来代替无线通信路径930以提供到控制单元920的有线连接。
以这种方式,在本发明的一个实施例中,集成输液装置和分析物监测系统900并不使用输液管,由于无需另外戴用不方便的输液管,其可以为患者提供另外的舒适度和方便。
图10是根据本发明一个实施例的结合有分析物监测系统传感器电极的输液装置插管的详图。参照图10,其示出了内设有分析物传感器电极1020的输液装置插管,该输液装置插管安装于粘附贴剂1010,以便牢固地保持其在患者身上的位置。更具体地,如从图10可以看到的,带有分析物传感器电极1020的插管包括传感器电极1021、1022、1023(其可以分别对应于工作电极、参考电极以及反电极),每一个都设置在插管顶端1020内,并且进一步被定位以便保持与患者的分析物液体接触。在一个方面,分析物传感器的部分或所有电极可缠绕在插管上、堆叠在插管的一处或多处内表面和/或外表面位置上。
图12A至12C分别示出了根据本发明不同实施例结合有图10的连续分析物监测系统传感器电极的输液装置插管的横截面图。参照图12A,在一个实施例中,导线和管平行设置,使得管壁1020、用于胰岛素流动的管芯1024、导线外套管1020以及各根绝缘导线1021、1022、1023基本上如图12A所示的设置。更具体地,从该附图可以看到,三根绝缘导线中的每一根均设置有独立围绕每根绝缘导线1021、1022、1023的由管壁形成的绝缘层1020,并且,三根绝缘导线1021、1022、1023进一步被管壁1020包围。
现在参照图12B,在本发明的一个实施例中,分别连接于传感器电极的绝缘导线1021、1022、1023被联合挤压成形在管壁1020内,用于胰岛素输送的管芯1024和绝缘导线1021、1022、1023的构造基本上如图12B所示。现在参照图12C,在本发明的又一具体实施例中,每根绝缘导线1021、1022、1023都缠绕在管1020上并覆盖有护套1210,从而提供管壁1020、用于胰岛素输送的管芯1024、单个绝缘导线1021、1022、1023、以及外保护护套1210,其还可以用作电磁屏蔽以消除电子噪声,基本上如附图所示。
再次参照这些附图,示于图12A和图12C示出的实施例可能具有更大的横截面积(因此需要在患者皮肤上穿刺更大的孔),然而也许更容易制造、更可靠以及更容易连接到分析物传感器电子设备。另外,在本发明的范围内,可以提供沿着传感器和泵之间的胰岛素输送管的光数据传输(即,纤维光学)而不是如上所述的集成导线。
图11A示出了根据本发明另一实施例的结合有分析物监测系统传感器电极的输液装置插管的部件透视图,而图11B示出了根据本发明一个实施例的结合有输液装置的分析物监测系统发送器单元的俯视平面图。参照图11A至图11B,在本发明的一个实施例中,集成分析物传感器和输液装置插管1100包括5个薄片层,这5个薄片层包括顶部绝缘层1101、其上设置有电极迹线(electrode trace)的导电层1102、接着是具有集成输液插管的三层基板1103。
在一个实施例中,具有集成输液插管的三层基板1103包括:隔离/绝缘层1103A,以使传感器电极和输液插管绝缘;通道层1103B,其被构造为引导胰岛素或任何其它适宜药物的流动;以及入口/出口层1103C。图11A中还示出集成分析物传感器和输液装置插管1100的装配图。
现在参照图11B,可以看到,如在一个实施例中所示的贴剂泵设置有发送器单元1110以及胰岛素泵1130,胰岛素泵接合于胰岛素储液器1120,并可操作地接合至或安装于发送器单元1110。图11B中还示出了分析物传感器触点1140,其被构造为与集成输液插管和分析物传感器1100的各个电极建立电接触。图11B中还示出了胰岛素端口1150,其连接于集成输液装置插管和分析物传感器1100的通道层1103B。
以这种方式,在本发明的一个实施例中,贴剂泵可以戴用在患者皮肤上,并且其包括胰岛素输注机构以及分析物传感器和发送器单元。
图13是定时图,用于说明在一个实施例中由集成输液装置和监测系统进行的血糖测量和胰岛素输送的时间间隔。更具体地,胰岛素泵通常以周期方式输送胰岛素,输送周期在2至3分钟的范围内并且在每个周期输送的持续时间约为几秒钟或更短。每个周期输送的胰岛素量可以根据所希望的总胰岛素输送速率而变化。连续收集分析物数据(例如,作为连续的葡萄糖氧化电流),但通常周期地报告给使用者。分析物报告周期通常是1至10分钟并且需要收集葡萄糖氧化电流10至30秒,以便产生可报告的葡萄糖数值(以便于筛选(filtering)等)。
事实上,分析物监测和胰岛素输送的结合有必要使分析物传感器的放置位置极接近于身体上的胰岛素输液插管。这样的极接近使得胰岛素输送有可能干扰分析物测量。例如,如果胰岛素输注将导致输注部位附近体内区域的葡萄糖浓度的局部降低,那么在此区域的葡萄糖测量结果不能代表整个体内的葡萄糖浓度。因此,在本发明的一个实施例中,提供了一种将血糖测量和胰岛素输送在时间上隔开的方法,以缓和胰岛素输注和葡萄糖测量之间的可能的干扰。
根据一个实施例,分析物测量和胰岛素输送的时间间隔可包括提供从胰岛素输送以后至进行分析物测量之前的大的时间间隔。由于分析物测量和胰岛素输送均是周期性进行的,如果在胰岛素输送之前基本上立即进行分析物测量则可以实现最大时间间隔。在胰岛素输送和其后的葡萄糖测量之间的期间,输注的胰岛素有时间扩散并且因间质液的正常循环而被传输离开输注部位。图13示出了时间上隔开的分析物测量和胰岛素输送的时间线(timeline)的一个实例。如果在胰岛素输送点之间进行多次分析物测量,总会有刚好在胰岛素输送之前以及刚好在胰岛素输送以后的一个读数,以将注射胰岛素对葡萄糖测量读数的影响降到最小程度。
虽然为了简化处理通常周期性地读取读数,某一读数可以不与其它读数同步读取并适当调整为总读数的平均值。类似地,由于读数通常比输注更频繁地发生,可以稍微延迟胰岛素输送点直到读数具有很小或没有影响以后,以使输注作用更长的一段时间。此外,在本发明的范围内,根据患者使用集成输液装置和分析物监测系统的环境,可以考虑其它定时需要考虑的问题,以将测得的分析物水平的潜在误差和/或引入的噪声或对输液装置的输液速率的潜在不利影响降至最小程度。
更具体地,输液装置和/或分析物监测系统的电源(例如,包括电池或相关配电电路)的波动可能引入电噪声效应,电噪声效应可能不利地影响测得的与分析物监测系统有关的读数。例如,当分析物监测系统被构造成处于活动状态以传输或接收数据时,或当输液装置的泵送周期运行时,电源可能受到来自数据传输/接收、或泵送周期的影响。除来自电子电路其它部件的噪声以外,电源的不利影响可能引入不希望的噪声并不利地影响分析物传感器测量结果的准确性。
因此,例如,发送器单元150(图1)可被构造为监测接收自分析物传感器160的测得的分析物水平的定时或发生以及发送器单元150的数据传输定时,以使两个事件基本上不会交迭或基本上在相同的时间发生。可替换地,分析物监测器单元120(图1)可被构造成比较分析物传感器160测量的定时和来自发送器单元150的数据传输的定时,并除去接收自发送器单元150并与分析物传感器160的分析物测量的定时相符的数据分析物相关数据。
此外,在一个实施例中,通过监测液体移动可以检测胰岛素管中的气泡,其也可以检测诸如管线中的气泡导致的液体的缺少。在一个实施例中,流量传感器可被构造为当气泡存在时产生零电流(zero current)。
此外,胰岛素的彩色化(colorization)可用于检测管中的气泡。由于药用胰岛素是透明无色液体,难以从视觉上区分将胰岛素从胰岛素泵输送到插管的管中的胰岛素和空气。通过给胰岛素提供色彩色调(color tint),将更容易从视觉上识别管中的气泡并且能够在它们引起问题以前将它们除去。在一个实施例中,胰岛素色调是生物相容的以及胰岛素相容的。
在一些实施例中,集成系统(例如,输液装置和分析物监测系统100(图1))的各个部件可能需要周期性地更换,而在集成系统的使用过程中,这些部件可能需要在不同的时间进行更换。例如,输液装置插管可能需要在每使用大约3天之后进行更换,而分析物监测系统中使用的分析物传感器可能直到使用了大约5天或7天之后才需要更换。因此,在一个实施例中,集成系统的部件可设置为可更换的模块化部件,使得在集成系统的使用过程中可以在不同时间更换一个或多个部件,基本上不会影响集成系统的其余部分。
更具体地,图14A至14C示出了根据一个实施例的药物输送和生理条件监测系统的模块化组合。参照图14A至14C,身体上的贴剂泵外壳1401可设置在患者的皮肤表面1404上,使得插管1402穿过患者的皮肤表面1404皮下定位在患者体内。还示出了设置在贴剂泵外壳1401上的连接口1403。如下面进一步详细描述的,在一个实施例中,如果贴剂泵仅用作泵,那么连接口1403可被构造为接合至端帽1405(图14B),或可替代地,当用作具有分析物监测系统的集成系统时,贴剂泵可被构造为接合至分析物传感器连接部1406。
参照附图,如所能看到的,分析物传感器可包括:连接部1406,其被构造为接合至贴剂泵外壳的连接口1403,以建立基本上防水的密封;固定部,被构造为将分析物传感器牢固地定位在患者的皮肤表面1404上;以及尖端部1408,穿过患者的皮肤表面1404而皮下定位,以与患者的分析物液体接触的。
以这种方式,在一个实施例中,分析物传感器可设置为可与贴剂泵共同使用作为集成系统的模块化部件。可替换地,如上所述,患者可选择只使用贴剂泵,不使用集成系统的连续监测部分。在此情况中,这里所述的模块化系统可简单地用作单独的泵,其中,端帽可被构造为向贴剂泵的外壳1401提供基本上防水的密封。
可替换地,贴剂泵可与分析物监测系统共同使用,其中,贴剂泵外壳1401可被构造为接合至传感器连接部1406,建立传感器电极之间与贴剂泵外壳1401内的相应内部电子部件的电接触。在此情况中,与分析物监测系统相关的电子部件(包括发送器单元、处理单元及分析物监测系统的其他部件)可基本上设置在贴剂泵外壳1401内。
以这种方式,在本发明的某些方面中,集成系统可用作单独的输液装置,贴剂泵和分析物传感器可彼此独立地更换或更改,并且基本上不会增加整个系统的轮廓或在身体上的大小,传感器可独立于贴剂泵而插入或定位于患者体内,也可独立于泵外壳1401而被去除。
图15A至15C示出了根据另一实施例的药物输送和生理条件监测系统的模块化组合。参照附图,与图14A至14C所示的实施例类似,集成系统设置有贴剂泵外壳1501,其被构造为定位在患者的皮肤表面1504上,并可操作地接合至皮下定位的插管1502,以向患者输送药物。
在图15A至15C所示的实施例中,贴剂泵的连接口1503基本设置在泵外壳1501的顶面上,使得(当需要时)分析物传感器连接部1506可经由连接口1503从贴剂泵的顶面接合至贴剂泵。可替换地,如图15B所示,在一方面,当贴剂泵外壳1501不与分析物传感器连接时,可提供帽或塞子1505来密封(例如,防水密封)连接口1503,因而用作单独的输液装置。一方面,帽或塞子1505可包括任何适当的构造,优选地包括小轮廓(low profile)物理尺寸,以保持身体上的贴剂泵外壳1501的小轮廓构造。
和前面一样,在具体实施例中,连接口1503被构造为建立与分析物传感器的各个电极的电连接,同时在连接处提供防水密封。再次参照附图,分析物传感器包括被构造为将分析物传感器牢固地定位在患者的皮肤表面1504上的固定部1507、以及被构造为皮下定位以与患者的分析物液体接触的尖端部1508。
虽然上述实施例包括设置在贴剂泵外壳的端面或顶面上的贴剂泵外壳连接口,但是,在本发明的范围内,贴剂泵连接口可设置在贴剂泵外壳的任何位置。例如,在本发明的范围内,当与端帽连接(以建立密封)、或与分析物传感器(以使用具有分析物监测的集成系统中的贴剂泵)连接时,可在贴剂泵外壳的底面、侧面或任何其他表面设置提供防水密封的连接口。
图16示出了根据一个实施例的模块化传感器部件的俯视平面图。更具体地,图16示出了一个实施例中的图14A至14C或图15A至15C的分析物传感器。如所示出的,分析物传感器的连接部1506基本上设置在分析物传感器的一端,而分析物传感器的传感部1508(用于皮下放置)基本上设置在传感器的另一端。图16还示出了固定部1507,在一个实施例中,其被构造为具有比传感器的其他部分相对大的宽度。
以这种方式,固定部1507可被构造为基本上牢固地将分析物传感器保持在患者的皮肤表面上。此外,贴剂泵外壳和分析物传感器中的一个或多个可在底面上设置粘合层,以在使用过程中固定在患者的皮肤表面上。在另一方面中,分析物传感器可包括柔性电路,以当戴用在患者的身体上时提供较小的轮廓。
图17示出了根据又一实施例的药物输送和生理条件监测系统的模块化组合。参照图17,贴剂泵1701设置有连接口1703,并定位在患者的皮肤表面1704上,以将皮下定位的插管1702以想要的深度固定地保持在患者的皮肤层下。附图还示出了连接装置1706,其在一个实施例中设置有泵连接器1705和传感器连接器1707。更具体地,在一个实施例中,提供了单独的模块化部件,并固定在患者的皮肤表面1704上,并可被构造为连接至贴剂泵1701和分析物传感器。此外,在本发明的范围内,连接装置1706可被构造为进一步接合至可能想要的其他部件或装置。
再次参照图17,一方面,连接装置1706被构造为在传感器和贴剂泵之间建立电连接,使得从分析物传感器的尖端部1710检测的分析物水平被贴剂泵外壳1701内的适当的电子控制电路接收。在替代实施例中,与分析物监测相关的电子部件(例如,数据处理单元、发送器单元等)可设置在连接装置1706内。在此情况中,贴剂泵外壳1701的尺寸可进一步优化。
再次参照图17,在一个实施例中,连接装置1706被构造为包括泵连接器1705,该泵连接器在一个实施例中被构造为接合至泵的连接口1703以建立电接触和基本防水的密封。此外,连接装置1706可进一步被构造为包括传感器连接部1707,传感器连接部被构造为接收或连接至传感器的连接部1708以建立与传感器的各个电极的电接触。即,在一个实施例中,连接装置1706的连接部1707可被构造为接合至传感器连接部1708。因此,当传感器尖端1710插入患者的皮肤表面1704与患者的分析物液体接触并由粘合片部1709牢固地保持在适当位置时,传感器连接部1708在一个实施例中被构造为建立与连接装置1706的电接触,以传递或延迟与检测到的患者的分析物水平相关的信号水平信息,以进行进一步处理。
以这种方式,在本发明的一个方面,提供了模块化部件或装置,包括集成药物输送和分析物监测系统,其中,每个部件可独立地更换、去除,或独立使用,并且,模块化部件可共同用作用于药物输送和分析物监测的集成系统。
因此,在一方面,用于提供集成药物输送和生理条件监测的模块化系统包括构造用于药物输送的第一模块化部件和构造为用于分析物水平检测的第二模块化部件,其中,第二模块化部件可连接至第一模块化部件,以与第一模块化部件建立电接触,当第一和第二模块化部件连接时形成基本防水的密封,并且,第一模块化部件和第二模块化部件中的一个被构造为可以独立于另一个部件被更换,并且,当第一模块化部件与第二模块化部件分开时,第三模块化部件可连接至第一模块化部件。
一方面,第一模块化部件可包括用于接合至第二模块化部件或第三模块化部件中的任一个的连接口。
第一模块化部件可包括小轮廓输液装置。
第二模块化部件可包括分析物传感器。
此外,一方面,当第一和第三模块化部件连接时,可形成防水密封。
在又一方面,第一模块化部件可被构造为在患者身体上的第一位置处将药物输送至患者,并且此外,第二模块化部件被构造为检测患者身体上第二位置处的患者的分析物水平,其中,第一和第二位置可隔开预定距离,例如,大约12英寸。
在另一方面,第一模块化部件可包括可重复使用的部分和一次性使用的部分,其中,第二或第三模块化部件中的任一个都可连接至第一模块化部件的可重复使用的部分。
第一模块化部件的一次性使用的部分可包括输液组或容纳有用于输送的药物的储液器中的一个或多个。
第一模块化部件的可重复使用的部分可包括控制第一模块化部件或第二模块化部件中的一个或多个的操作的处理单元。
在又一方面,系统可包括设置在第一模块化部件或第二模块化部件中的一个或多个中的通信单元,通信单元被构造为发送或接收来自远端位置的数据。
远端位置可包括便携控制单元、计算机终端、服务器终端、移动电话,或个人数字助理中的一个或多个。
通信单元可被构造为向远端位置发送与一个或多个分析物水平相应的一个或多个信号。
在另一方面,通信单元可被构造为接收流量指令,以控制药物的输送。
此外,在又一方面,通信单元可被构造为通过RF通信链路、蓝牙通信链路、或红外线通信链路中的一种或多种进行无线通信。
在另一方面,第二模块化部件可包括内壁和外壁、设置在内壁与外壁之间的多个电极、以及由内壁形成的液体输送通道,其中,多个电极可包括分析物传感器。
根据另一实施例,一种方法可包括:提供用于药物输送的第一模块化部件;提供构造用于分析物水平检测的第二模块化部件,第二模块化部件可连接至第一模块化部件,以与第一模块化部件建立电接触,当第一和第二模块化部件连接时形成基本防水的密封;以及提供第三模块化部件,当第一模块化部件与第二模块化部件分开时,第三模块化部件可连接至第一模块化部件,其中,第一模块化部件和第二模块化部件中的一个被构造为可以独立于另一个部件被更换。
在另一方面,该方法可包括将药物输送给患者,并基本在药物输送的同时监测患者的分析物水平。
根据又一方面,一种用于提供集成药物输送和生理条件监测的模块化系统包括构造用于药物输送的可更换第一模块化部件、构造用于分析物水平检测的可更换第二模块化部件,其中,第二模块化部件可连接至第一模块化部件,以与第一模块化部件建立电接触,并且,当第一模块化部件与第二模块化部件分开时,第三模块化部件可连接至第一模块化部件,其中,当第一和第二模块化部件连接时或当第一和第三模块化部件连接时,形成基本防水的密封。
第一模块化部件和第二模块化部件中的一个被构造为可以独立于另一个部件被更换。
第一模块化部件可包括用于连接至第二模块化部件或第三模块化部件中的任一个的连接口,并且,第三模块化部件可包括被构造为连接至第一模块化部件的连接口的帽。
帽可包括端帽或塞子。
所监测的分析物水平可包括葡萄糖水平。
第一模块化部件可包括小轮廓输液装置。
第二模块化部件可包括分析物传感器。
第一模块化部件可被构造为在患者身体上的第一位置处将药物输送至患者,并且,第二模块化部件被构造为检测患者身体上的第二位置处的患者的分析物水平。
在又一方面,第一和第二位置隔开预定距离。
第一模块化部件可包括可重复使用的部分和一次性使用的部分,其中,第二或第三模块化部件中的任一个都可连接至第一模块化部件的可重复使用的部分。
第一模块化部件的一次性使用的部分可包括输液组(infusionset)或容纳有用于输送的药物的储液器中的一个或多个。
第一模块化部件的可重复使用的部分可包括控制第一模块化部件或第二模块化部件中的一个或多个的操作的处理单元。
系统还可包括设置在第一模块化部件或第二模块化部件中的一个或多个中的通信单元,通信单元被构造为发送或接收来自远端位置的数据,并且,远端位置可包括便携控制单元、计算机终端、服务器终端、移动电话,或个人数字助理中的一个或多个。
通信单元可被构造为向远端位置发送与一个或多个分析物水平相应的一个或多个信号。
此外,通信单元可被构造为接收流量指令,以控制药物的递输送。
通信单元可被构造为通过RF通信链路、蓝牙通信链路、或红外线通信链路中的一种或多种进行无线通信。
在又一方面,第二模块化部件可包括内壁和外壁、设置在内壁和外壁之间的多个电极、以及由内壁形成的液体输送通道。
多个电极可包括分析物传感器。
根据另一方面,一种方法包括:将可更换的第一模块化部件定位在使用者的皮肤表面上;在第一时间周期过程中将可更换的第二模块化部件连接至第一模块化部件上的预定位置,其中,在第一模块化部件与第二模块化部件之间形成防水密封;以及在第二时间周期过程中将第三模块化部件连接至第一模块化部件上的预定位置,其中,在第一模块化部件与第二模块化部件之间形成防水密封,并且,第一时间周期和第二时间周期不交迭。
该方法可包括将药物输送给使用者,并监测使用者的分析物水平。
在又一方面,一种工具包可包括:构造用于输送药物的输液装置,输液装置包括端口;构造用于监测使用者的分析物水平的分析物监测装置,在第一预定时间周期中,分析物监测装置可连接至输液装置的端口;以及帽,在第二预定时间周期中,帽可连接至输液装置的端口,其中,第一时间周期和第二时间周期不交迭。
输液装置可包括身体上的贴剂泵。
当连接至输液装置时,帽提供端口处的防水密封。
当连接至输液装置时,分析物监测装置提供开口处的防水密封。
在又一方面,一种包括:输液装置和分析物监测单元的系统包括输液装置;身体上的单元,包括数据传输部分,身体上的单元进一步接合至输液装置,身体上的单元被构造为接收与一个或多个分析物水平相应的一个或多个信号,并且,身体上的单元被构造为输注接收自输液装置的液体;以及接收器单元,可操作地接合至身体上的单元,接收器单元被构造为接收来自身体上的单元数据,其中,所接收的数据与分析物水平相关。
系统可进一步包括分析物传感器,至少分析物传感器的第一部分与患者的分析物液体接触,并且,分析物传感器的第二部分与数据传输部分进行信号通信。
在一个实施例中,数据传输部分可被构造为以一个或多个预定时间间隔基本上周期性地传输与一个或多个分析物水平相应的一个或多个信号,其中,一个或多个预定时间间隔可包括大约30秒、大约1分钟,或大约90秒中的一种或多种。
在一个方面,身体上的单元可包括:插管,至少插管的一个部分皮下定位在皮肤层下;并且进一步还可包括输液管,其连接至输液装置以将液体输送至身体上的单元。在另一方面,输液管和身体上的单元可在基本上防水的密封中连接。
在又一实施例中,输液管可被构造为可操作地接合至插管,以输送液体。
身体上的单元可被构造为向接收器单元无线传输与一个或多个分析物水平相应的一个或多个信号,其中,身体上的单元和接收器可被构造为通过RF通信链路、蓝牙通信链路、或红外线通信链路中的一种或多种进行无线通信。
另外,在另一实施例中,输液装置可被构造为基于接收器单元所接收的与一个或多个分析物水平相应的一个或多个信号来控制液体的输送速率,并且,输液装置可被构造为基于与一个或多个分析物水平相应的一个或多个信号有关的信息确定用于输送液体(例如胰岛素)修正的的输送方案。
在又一方面,修正的输送方案可包括矫正推注、修正的基础方式、碳水化合物推注、追加推注、或其组合中的一种或多种。
在一个实施例中,接收器单元可被构造为与输液装置无线通信。
在另一实施例中,接收器单元可结合到输液装置的外壳中。
在本发明的另一实施例中,一种结合分析物监测和液体输注的方法包括:以预定输送速率输注液体,检测一个或多个分析物水平,传输与测得的一个或多个分析物水平有关的一个或多个信号,以及基于所传输的一个或多个信号来确定修正的输送速率。
在一个方面,可以在检测有关的一个或多个分析物水平之后基本上立即传输上述一个或多个信号。
此外,在一个实施例中,传输步骤可以包括通过RF通信链路、蓝牙通信链路、红外线通信链路、或其组合中的一种或多种来无线传输一个或多个信号。
在另一方面中,该方法还可以包括以下步骤:接收所传输的一个或多个信号,以及显示所接收的一个或多个信号。
此外,该方法还可包括显示修正的输送速率的步骤。此外,该方法还可包括实施修正的输送速率的步骤,其中,预定输送速率可包括一个或多个基础输送速率。
在另一实施例中,修正的输送速率可包括矫正推注、修正的基础方式、碳水化合物推注、追加推注、或其组合中的一种或多种。
在本发明的另一实施例中,一种包括分析物传感器和液体输送通道的装置包括液体递输送单元,该单元具有内壁和外壁、以及设置在液体输送单元内壁和外壁之间的多个电极,其中,液体输送单元的一部分以及多个电极的一部分皮下定位在皮肤层的下面。
一方面,多个电极可包括分析物传感器,分析物传感器包括诸如工作电极、反电极、参考电极、或其组合中的一个或多个。
液体输送单元可包括用于输送液体(例如胰岛素)的通道,该通道基本上由内壁形成。
根据本发明的又一实施例,一种包括分析物传感器和液体输送通道的装置包括:具有第一管通道的第一管;以及具有第二管通道的第二管,其包括设置在第二管通道内的多个电极,其中,至少第一管的一部分和至少第二管的一部分皮下定位在皮肤层下面。
在一个实施例中,多个电极可基本上彼此完全绝缘。
在另一实施例中,可以整体形成第一管和第二管,以使第一管的外表面基本上与第二管的外表面接触。
根据本发明的又一实施例,一种包括输液装置和分析物监测单元的系统包括:输液和监测装置;包括数据传输部分的身体上的单元,该身体上的单元进一步接合至输液和监测装置,该身体上的单元被构造为接收对应于一个或多个分析物水平的一个或多个信号,并且进一步地,该身体上的单元成被构造为输注接收自输液和监测装置的液体;以及连接器,其在第一端接合至输液装置并在第二端接合至身体上的单元,该连接器被构造为将液体从输液装置输送到身体上的单元,并且进一步被构造为向输液和监测装置提供对应于一个或多个分析物水平的一个或多个信号。
在一方面,输液和监测装置可被构造为将液体输送至患者,并且进一步在预定时间周期内检测患者的分析物水平。
在另一方面,输液和监测装置可包括连续葡萄糖监测系统。
在又一个方面,输液和监测装置可包括胰岛素泵。
根据本发明的另一实施例,一种液体输送和分析物监测的方法包括:确定用于液体输注的输送方式(delivery profile),其中,输送方式包括由预定时间在时间上彼此隔开的多次预定的不连续的液体输注;以及基本上在每此预定的不连续的液体输注以前立即对分析物水平进行采样。
该方法可进一步包括基本上在每次预定的不连续的液体输注以后立即对分析物水平进行采样的步骤。
除背景技术和发明内容部分之外,本文所引用的上述所有参考内容在此都结合入优选实施例的详细描述中以供参考,作为公开的可替代实施例和部件。
对本领域的技术人员来说,在不偏离本发明的范围和精神的情况下,对本发明的结构和操作方法的各种其他改进和更改将是显而易见的。虽然已结合具体的优选实施例对本发明进行了描述,但应当理解,所要求的本发明不应不适当地限制于这样的具体实施例。
Claims (27)
1.一种用于提供集成药物输送和生理条件监测的模块化系统,包括:
可更换的第一模块化部件,构造为用于药物输送;
可更换的第二模块化部件,构造为用于分析物水平检测,其中,所述第二模块化部件可连接至所述第一模块化部件,以与所述第一模块化部件建立电接触;以及
可更换的第三模块化部件,当所述第一模块化部件与所述第二模块化部件分开时,所述第三模块化部件可连接至所述第一模块化部件;
其中,当所述第一和第二模块化部件连接时,或者当所述第一和第三模块化部件连接时,形成基本上防水的密封。
2.根据权利要求1所述的系统,其中,所述第一模块化部件和所述第二模块化部件中的一个构造为用于独立于另一个部件更换。
3.根据权利要求1所述的系统,其中,所述第一模块化部件包括
用于接合至所述第二模块化部件或所述第三模块化部件中的任一个的连接口。
4.根据权利要求3所述的系统,其中,所述第三模块化部件包括构造为接合至所述第一模块化部件的所述连接口的帽。
5.根据权利要求1所述的系统,其中,所述第三模块化部件包括帽。
6.根据权利要求5所述的系统,其中,所述帽包括端帽或塞子。
7.根据权利要求1所述的系统,其中,所述分析物包括葡萄糖。
8.根据权利要求1所述的系统,其中,所述第一模块化部件包括小轮廓输液装置。
9.根据权利要求1所述的系统,其中,所述第二模块化部件包括分析物传感器。
10.根据权利要求1所述的系统,其中,所述第一模块化部件构造为在患者身体上第一位置处将药物输送至患者,并且其中,所述第二模块化部件构造为检测患者身体上第二位置处的分析物水平。
11.根据权利要求10所述的系统,其中,所述第一和第二位置间隔预定距离。
12.根据权利要求11所述的系统,其中,所述预定距离包括小于12英寸的距离。
13.根据权利要求1所述的系统,其中,所述第一模块化部件包括可重复使用的部分和一次性使用的部分,其中,所述第二或第三模块化部件中的任一个都可连接至所述第一模块化部件的所述可重复使用的部分。
14.根据权利要求13所述的系统,其中,所述第一模块化部件的所述一次性使用的部分包括输液组或容纳有用于输送的药物的储液器中的一个或多个。
15.根据权利要求13所述的系统,其中,所述第一模块化部件的所述可重复使用的部分包括控制所述第一模块化部件或所述第二模块化部件中的一个或多个的操作的处理单元。
16.根据权利要求1所述的系统,包括设置在所述第一模块化部件或所述第二模块化部件中的一个或多个中的通信单元,所述通信单元构造为传输或接收来自远端位置的数据。
17.根据权利要求16所述的系统,其中,所述远端位置包括便携控制单元、计算机终端、服务器终端、移动电话、或个人数字助理中的一个或多个。
18.根据权利要求16所述的系统,其中,所述通信单元构造为向所述远端位置传输与一个或多个分析物水平相应的一个或多个信号。
19.根据权利要求16所述的系统,其中,所述通信单元构造为接收流量指令,以控制药物的输送。
20.根据权利要求16所述的系统,其中,所述通信单元构造为通过RF通信链路、蓝牙通信链路、或红外线通信链路中的一种或多种进行无线通信。
21.根据权利要求1所述的系统,其中,所述第二模块化部件包括内壁和外壁、设置在所述内壁与所述外壁之间的多个电极、以及由所述内壁形成的液体输送通道。
22.根据权利要求21所述的系统,其中,所述多个电极包括分析物传感器。
23.一种工具包,包括:
可更换的第一模块化部件,构造为输送药物,所述可更换的第一模块化部件包括一端口;
可更换的第二模块化部件,构造为监测使用者的分析物水平,在第一预定时间周期过程中,所述可更换的第二模块化部件可连接至所述可更换的第一模块化部件的所述端口;以及
可更换的第三模块化部件,在第二预定时间周期过程中,所述可更换的第三模块化部件可连接至所述可更换的第一模块化部件的所述端口;
其中,所述第一预定时间周期和所述第二预定时间周期不交迭,并且
其中,所述可更换的第一模块化部件是输液装置,所述可更换的第二模块化部件是分析物监测装置,而所述可更换的第三模块化部件是帽。
24.根据权利要求23所述的工具包,其中,所述分析物包括葡萄糖。
25.根据权利要求23所述的工具包,其中,所述输液装置包括身体上的贴剂泵。
26.根据权利要求23所述的工具包,其中,当连接至所述输液装置时,所述帽提供端口处的防水密封。
27.根据权利要求23所述的工具包,其中,当连接至所述输液装置时,所述分析物监测装置提供端口处的防水密封。
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- 2008-02-15 US US12/032,593 patent/US9636450B2/en active Active
- 2008-02-16 BR BRPI0807515-8A patent/BRPI0807515A2/pt not_active IP Right Cessation
- 2008-02-16 CA CA002678565A patent/CA2678565A1/en not_active Abandoned
- 2008-02-16 CN CN2008800053887A patent/CN101631586B/zh not_active Expired - Fee Related
- 2008-02-16 WO PCT/US2008/054186 patent/WO2008103620A2/en active Application Filing
- 2008-02-16 RU RU2009135048/14A patent/RU2480251C2/ru not_active IP Right Cessation
- 2008-02-16 CN CN2012105685237A patent/CN103055378A/zh active Pending
- 2008-02-16 EP EP08730066A patent/EP2125096A4/en not_active Withdrawn
-
2010
- 2010-06-29 US US12/826,662 patent/US20100274112A1/en not_active Abandoned
-
2017
- 2017-05-01 US US15/582,878 patent/US20170296740A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
CN103055378A (zh) | 2013-04-24 |
RU2009135048A (ru) | 2011-03-27 |
RU2480251C2 (ru) | 2013-04-27 |
US20100274112A1 (en) | 2010-10-28 |
US20170296740A1 (en) | 2017-10-19 |
WO2008103620A2 (en) | 2008-08-28 |
BRPI0807515A2 (pt) | 2014-06-03 |
EP2125096A2 (en) | 2009-12-02 |
CN101631586A (zh) | 2010-01-20 |
EP2125096A4 (en) | 2012-11-07 |
WO2008103620A3 (en) | 2008-10-16 |
US9636450B2 (en) | 2017-05-02 |
CA2678565A1 (en) | 2008-08-28 |
US20080200897A1 (en) | 2008-08-21 |
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