CN103781411B - 具有远程激活的通信系统 - Google Patents

具有远程激活的通信系统 Download PDF

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CN103781411B
CN103781411B CN201280043374.0A CN201280043374A CN103781411B CN 103781411 B CN103781411 B CN 103781411B CN 201280043374 A CN201280043374 A CN 201280043374A CN 103781411 B CN103781411 B CN 103781411B
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CN103781411A (zh
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杰弗里·伯克曼
马克·J.·兹德伯雷科
帕特丽夏·约翰逊
霍曼·哈菲奇
乔纳森·惠特灵顿
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Proteus Digital Health Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/07Endoradiosondes
    • A61B5/073Intestinal transmitters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0538Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/72Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271Specific aspects of physiological measurement analysis
    • A61B5/7285Specific aspects of physiological measurement analysis for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/007Marking tablets or the like
    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01QANTENNAS, i.e. RADIO AERIALS
    • H01Q1/00Details of, or arrangements associated with, antennas
    • H01Q1/27Adaptation for use in or on movable bodies
    • H01Q1/273Adaptation for carrying or wearing by persons or animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0204Operational features of power management
    • A61B2560/0214Operational features of power management of power generation or supply
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/18Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A61B5/0008Temperature signals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/03Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
    • A61B5/036Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs by means introduced into body tracts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14539Measuring 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 pH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4836Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery

Abstract

本发明的系统包括导电元件、电子组件和呈相异材料形式的部分电源。在与导电流体接触后,形成电势且完成电源,这激活所述系统。所述电子组件控制相异材料之间的电导以产生唯一的电流签名。所述系统还可测量包围所述系统的环境的条件。

Description

具有远程激活的通信系统
相关申请的交叉参考
本申请是2011年7月11日提交的发明名称为“CommunicationSystemwithRemoteActivation”且在2012年1月12日公开为第2012/0007734A1号美国公开案的第13/180,516号申请的部分接续案,所述第13/180,516号申请是2009年9月21日提交的发明名称为“CommunicationSystemwithPartialPowerSource”并且在2010年4月1日作为第2010-0081894A1号美国公开案公开的第12/564,017号美国专利申请的部分接续案,所述第12/564,017号美国专利申请是2008年6月23日提交的发明名称为“Pharma-InformaticsSystem”并且在2008年11月20日作为第2008-0284599A1号美国公开案公开的第11/912,475号美国专利申请的部分接续申请,所述第11/912,475号美国专利申请是2006年4月28日提交的发明名称为“Pharma-InformaticsSystem”并且在2006年11月2日作为第WO2006/116718号WO公开案公开的第PCT/US06/16370号PCT申请的371申请,所述申请依据35U.S.C.§119(e),主张以下申请的申请日期的优先权:2005年4月28日提交的发明名称为“Pharma-InformaticsSystem”的第60/676,145号美国临时专利申请;2005年6月24日提交的发明名称为“Pharma-InformaticsSystem”的第60/694,078号美国临时专利申请;2005年9月1日提交的发明名称为“MedicalDiagnosticAndTreatmentPlatformUsingNear-FieldWirelessCommunicationOfInformationWithinAPatient’sBody”的第60/713,680号美国临时专利申请;以及2006年4月7日提交的发明名称为“Pharma-InformaticsSystem”的第60/790,335号美国临时专利申请;这些申请的公开内容以引用的方式并入本文中。
本申请与同时申请的以下美国申请相关,这些美国申请的公开内容以引用的方式并入本文中:第13/180,498号美国申请“COMMUNICATIONSYSTEMWITHMULTIPLESOURCESOFPOWER”,其在2012年1月5日公开为第2012/0004520A1号美国公开案;第13/180,539号美国申请“COMMUNICATIONSYSTEMUSINGANIMPLANTABLEDEVICE”,其在2012年1月5日公开为第2012/0004527A1号美国公开案;第13/180,525号美国申请“COMMUNICATIONSYSTEMWITHENHANCEDPARTIALPOWERANDMETHODOFMANUFACTURINGSAME”,其在2012年5月10日公开为第2012/0116188A1号美国公开案;第13/180,538号美国申请“POLYPHARMACYCO-PACKAGEDMEDICATIONDOSINGUNITINCLUDINGCOMMUNICATIONSYSTEMTHEREFOR”,其在2012年2月2日公开为第2012/0024889A1号美国公开案;以及第13/180,507号美国申请“COMMUNICATIONSYSTEMINCORPORATEDINANINGESTIBLEPRODUCT”,其在2012年3月15日公开为第2012/0062379A1号美国公开案。
技术领域
本发明涉及用于检测事件的通信系统。更具体地说,本公开包括一种系统,其包括具有各种电源和通信方案的装置。
背景技术
已经提议将包括电子电路的可摄取装置在多种不同医学应用中使用,所述医学应用包括诊断和治疗应用两者。这些装置通常需要用于操作的内部电力供应。此类可摄取装置的实例是可摄取电子胶囊,其在通过身体时收集数据并且将数据发送到外部接收器系统。这类电子胶囊的实例是活体内摄像机。可吞食胶囊包括相机系统和光学系统,所述光学系统用于将关注区域成像到相机系统上。发送器发送相机系统的视频输出,并且接收系统接收所发送的视频输出。其它实例包括可摄取成像装置,其具有内部自持电源且从身体内腔或腔体内获得图像。所述装置的电子电路组件由惰性不消化壳体(例如,玻璃壳体)封闭,所述壳体通过身体内部。其它实例包括可摄取数据记录器胶囊医学装置。所公开的装置的电子电路(例如,传感器、记录器、电池等)容纳在由惰性材料制成的胶囊中。
在其它实例中,在药品摄取监视应用中使用脆性射频识别(RFID)标签。为了使RFID标签操作,每一应用/标签需要内部电力供应。RFID标签是被配置为发送穿过身体的射频信号的天线结构。
这些现有装置造成的问题是,电源在装置内部,且此类电源的体积大,生产成本高,且如果电源泄漏或受损则可能对周围环境潜在有害。另外,当在活体内使用所述装置时,从装置延伸出天线是与天线受损或造成问题有关的顾虑。因此,需要具有不需要内部电源和天线的电路的合适系统。
发明内容
本公开包括一种用于产生指示事件的发生的唯一签名的系统。所述系统包括可放置在包括导电流体的某些环境内的电路和组件。此类环境的一个实例是在容纳导电流体的容器内,例如具有溶液的密封袋,其包括IV袋。另一实例是在活生物体(例如动物或人类)的身体内。所述系统是可摄取和/或可消化或部分可消化的。所述系统包括安置在框架上的相异材料,使得当导电流体与相异材料形成接触时,形成电势差。电势差以及因此电压用以对安置在框架内的控制逻辑上电。离子或电流经由控制逻辑且接着穿过导电流体从第一相异材料流动到第二相异材料以完成电路。控制逻辑控制所述两种相异材料之间的电导,因此控制或调制系统的电导。
由于可摄取电路是由可摄取且甚至是可消化的组分制成,所以所述可摄取电路产生极少(如果有的话)不需要的副作用,即使当在长期情况下使用时。可包括的组件的范围的实例是:逻辑和/或存储器元件;效应器;信号发送元件;以及无源元件,例如电阻器或电感器。支撑件的表面上的一个或多个组件可按任何便利配置来布置。在固体支撑件的表面上存在两个或两个以上的组件的情况下,可提供互连件。可摄取电路的所有组件和支撑件是可摄取的,且在某些例子中,是可消化或部分可消化的。
附图说明
图1示出根据本发明的教导的具有事件指示器系统的药物产品,其中所述产品和事件指示器系统组合在身体内。
图2A示出图1的药物产品,其具有在药物产品的外部上的事件指示器系统。
图2B示出图1的药物产品,其具有安置在药物产品内部的事件指示器系统。
图2C示出根据本发明的一个方面的内部安置有事件指示器系统的胶囊。
图2D示出根据本发明的一个方面的内部安置有事件指示器系统的胶囊。
图2E示出根据本发明的一个方面的内部安置有事件指示器系统的胶囊。
图2F是事件指示器系统的分解图。
图3是相对端部上安置有相异金属的事件指示器系统的一个方面的框图表示。
图4是同一端部上安置有相异金属且所述相异金属由不导电材料分开的事件指示器系统的另一方面的框图表示。
图5示出当图3的事件指示器系统与导电液体接触且处于活动状态时经过导电流体的离子转移或电流路径。
图5A示出图5的相异材料的表面的分解图。
图5B示出图5的具有pH传感器单元的事件指示器系统。
图6是图3和图4的系统中所使用的控制装置的一个方面的框图说明。
图7是根据一个方面的可存在于接收器中的执行相干解调的解调电路的功能框图。
图8说明根据一个方面的接收器内的信标模块的功能框图。
图9是根据一个方面的可存在于接收器中的不同功能模块的框图。
图10是根据一个方面的接收器的框图。
图11提供根据一个方面的接收器中的高频信号链的框图。
图12提供根据一个方面的可如何使用包括信号接收器和可摄取事件标示器的系统的图。
具体实施方式
本公开包括用于指示事件的发生的多个方面。如下文较详细描述,本发明的系统与导电流体一起使用以指示由所述导电流体与所述系统之间的接触所标示的事件。举例来说,本公开的系统可与药物产品一起使用,并且所指示的事件是何时服用或摄取所述产品。术语“摄取”应理解为意指将所述系统以任何方式引入到身体内部。举例来说,摄取包括简单地将系统放在口中直到降结肠。因此,术语摄取涉及将系统引入到含有导电流体的环境时的任何时刻。另一实例是当不导电流体与导电流体混合时的情形。在此类情形中,所述系统存在于不导电流体中,且当两种流体混合时,所述系统与导电流体形成接触并且所述系统被激活。又一实例是当存在需要被检测的某些导电流体时的情形。在这些例子中,可检测到所述系统(其可被激活)在导电流体内的存在,因此将检测到相应流体的存在。
再次参看系统与摄入到活生物体中的产品一起使用的例子,当服用或摄取包括所述系统的产品时,装置与身体的导电流体形成接触。当本发明的系统与体液形成接触时,产生电势且系统被激活。一部分电源由装置提供,而另一部分电源由导电流体提供,这在下文中详细论述。
现在参看图1,在身体内部示出包括本发明的系统的可摄取产品14。产品14被配置为呈药丸或胶囊形式的可经口摄取的药物配方。在摄取后,药丸移动到胃部。在到达胃部后,产品14与胃液18接触,且经历与胃液18中的各种物质(例如盐酸和其它消化剂)的化学或电化学反应。本发明的系统是参考药物环境来论述的。然而,本发明的范围不限于此。本发明可用于任何环境,例如,在身体外部,其中存在有导电流体或通过对产生导电流体的两种或两种以上的组分进行混合而变得存在有导电流体。
现在参看图2A,示出类似于图1的产品14的药物产品10,其具有系统12,例如可摄取事件标示器或离子发射模块(IEM)。本发明的范围不受产品10的形状或类型限制。举例来说,所属领域的技术人员将清楚,产品10可为胶囊、缓释口服剂、药片、凝胶胶囊、舌下药片或可与系统12组合的任何口服剂产品。在所提及的方面中,产品10利用已知的将微型装置紧固到药物产品外部的方法来使系统12紧固到外部。用于将微型装置紧固到产品的方法的实例在以下申请中公开:2010年1月5日提交的发明名称为“HIGH-THROUGHPUTPRODUCTIONOFINGESTIBLEEVENTMARKERS”的第12/741,583号美国临时申请,所述美国临时申请还在2010年1月5日申请为第PCT/US10/20142号PCT申请并且在2010年7月15日公开为WO2010/080765;以及2009年5月12日提交的发明名称为“INGESTIBLEEVENTMARKERSCOMPRISINGANIDENTIFIERANDANINGESTIBLECOMPONENT”的第61/177,611号美国临时申请,所述美国临时申请还在2010年5月10日申请为第PCT/US10/34186号PCT申请并且在2010年11月18日公开为WO2010/132331,上述每个的全部公开内容以引用的方式并入本文中。一旦被摄取,系统12便与体液形成接触且系统12被激活。系统12使用电势差来上电,且此后调制电导以产生唯一且可识别的电流签名。在激活后,系统12控制电导且因此控制电流流动以产生电流签名。
存在延迟系统12的激活的各种原因。为了延迟系统12的激活,系统12可被涂覆有屏蔽材料或保护层。所述层在一段时间后溶解,进而允许系统12在产品10已经到达目标位置时被激活。
现在参看图2B,示出类似于图1的产品14的药物产品20,其具有系统22,例如可摄取事件标示器或可识别发射模块。本发明的范围不受系统22所被引入的环境的限制。举例来说,系统22可封闭在除药物产品以外/独立于药物产品来服用的胶囊中。所述胶囊可仅仅是用于系统22的载体,并且可以不含有任何产品。此外,本发明的范围不受产品20的形状或类型限制。举例来说,所属领域的技术人员将清楚,产品20可为胶囊、缓释口服剂、药片、凝胶胶囊、舌下药片或任何口服剂产品。在所提及的方面中,产品20使系统22安置在产品20内部或紧固到产品20的内部。在一个方面中,系统22紧固到产品20的内壁。当系统22安置在凝胶胶囊内部时,那么凝胶胶囊的内含物是不导电凝胶液体。另一方面,如果凝胶胶囊的内含物是导电凝胶液体,那么在替代方面中,系统22被涂覆有保护罩以防止由凝胶胶囊内含物不必要地激活。如果胶囊的内含物是干燥粉末或微球体,那么系统22安置或放置在胶囊内。如果产品20是药片或硬药丸,那么系统22在药片内部保持在位。一旦被摄取,含有系统22的产品20便分解和/或溶解。系统22与体液形成接触,且系统22被激活。取决于产品20,系统22可安置在中心附近或周边附近位置,这取决于系统22的初始摄取与激活时间之间的期望激活延迟。举例来说,用于系统22的中心位置意味着系统22将需要更长时间来与导电液体接触,因此系统22将需要更长时间来被激活。因此,将需要更长时间来检测事件的发生。
现在参看图2C,根据本发明的一个方面,示出中间具有空腔11a的胶囊11。根据本发明的一个方面,胶囊11被示出为空胶囊。系统12a在空腔内部,所述系统12a类似于图2A的系统12和图2B的系统22。在胶囊11被引入到导电流体中或与导电流体形成接触时,胶囊11裂开或分解或溶解以允许从环境释放系统。
现在参看图2D,示出胶囊11,其具有系统12a连同嵌入到空腔11a中的材料13。材料13可被激活以膨胀并促使胶囊11裂开。根据本发明的一个方面,材料13的激活由系统12a控制。系统12a(如以下图2E所示)从可位于身体内部、身体上或身体外部的外部源接收信号,并且响应于所述信号能够激活材料13以促使材料12膨胀。举例来说,根据本发明的一个方面,材料13是电活性材料,其被选择为对电信号具有反应性,使得当暴露于电势或电流时属性改变。电活性材料或基体包括例如物理尺寸或溶解度等属性响应于所施加的电压或电流而改变的材料。电活性材料的实例包括:聚偏二氟乙烯(PVDF)、全氟磺酸(NafionTM)、全氟羧酸(FlemionTM)、纤维素、含有盐(例如,含有多价离子(例如Fe3+)的盐)的聚合物基体(例如,聚氧化乙烯或纤维素)或蛋白质。根据本发明的另一方面,系统12a包括向材料11a中释放化学物或化合物以引起促使材料11a膨胀的化学反应的柱塞。
现在参看图2E,更详细地示出胶囊11,其具有系统12a。系统12a包括紧固到系统12a的单元12b。根据本发明的一个方面,单元12b包括限定空腔12c的壳体。在一个实例中,空腔12c可被填充有化学物或化合物,所述化学物或化合物在空腔11a被填充有材料13时释放到空腔11a中以开启促使材料13膨胀的反应。现在还参看图2F,在另一实例中,空腔12c包括充当针或杆的固体物体。所述物体在如图所示的方向AA上被机械地推出空腔12c。接着所述物体能够挤过胶囊11的壁且促使壁戳破或裂开。这促使系统12a与胶囊11分开且允许系统12a与周围环境形成接触并被激活。因此,单元12b能够控制系统12a的激活。
根据本发明的一个方面,单元12b包括能够接收、发送、或接收和发送的通信模块。因此,单元12b可充当二级通信模块,如下文关于图5和元件75详细论述。根据本发明的一个方面,单元12b可从外部源接收控制信号。根据另一方面,单元12b可将信号发送到外部源。根据本发明的又一方面,单元12b充当收发器,且能够接收信号并向外部装置发送信号。单元12b还与系统12a的其它组件通信,如下文详细论述。
现在参看图3,在一个方面中,图2A的系统12和图2B的系统22被更详细地示出为系统30。系统30可与任何药物产品联合使用,如上文所提及,以确定何时患者摄取了所述药物产品。如上文所示,本发明的范围不受环境和与系统30一起使用的产品限制。举例来说,系统30可放置在胶囊内,且胶囊被置于导电液体内。接着胶囊在一段时间后溶解并且将系统30释放到导电液体中。因此,在一个方面中,胶囊含有系统30而没有产品。此类胶囊于是可用于存在导电液体的任何环境中以及与任何产品一起使用。举例来说,胶囊可放入填充有航空燃油、盐水、番茄酱、机油或任何类似产品的容器中。另外,可在摄取任何药物产品的同时摄取含有系统30的胶囊以便记录事件的发生,例如何时服用了所述产品。
在与药物产品组合的系统30的特定实例中,随着摄取产品或药丸,系统30被激活。系统30控制电导以产生被检测的唯一电流签名,进而表示已经服用药物产品。系统30包括Vhigh与接地52之间的电阻31。电阻元件包括已知量,且表示Vhigh与接地之间的电压降。该已知量用以确定周围环境的阻抗,如关于以下图5和单元75a指出。
系统30包括框架32。框架32是用于系统30的底架,且多个组件附接到框架32、沉积在框架32上或紧固到框架32。在系统30的这个方面中,可摄取或可消化材料34在物理上与框架32相关联。材料34可化学沉积在框架上、蒸镀到框架上、紧固到框架或构建在框架上,其全部可以在本文中称为相对于框架32“沉积”。材料34沉积在框架32的一侧。可用作材料34的关注材料包括但不限于:Cu或CuI。材料34通过物理气相沉积、电沉积或等离子体沉积以及其它方法来沉积。材料34可为约0.05到约500μm厚,例如约5到约100μm厚。形状由阴影掩模沉积或光刻和刻蚀来控制。另外,尽管只示出一个区用于沉积所述材料,但每个系统30可根据需要而含有两个或两个以上的电性唯一区,在所述区可沉积材料34。
在不同侧(其为如图3所示的相对侧),沉积另一可消化材料36,使得材料34和36相异且彼此隔离。虽然未图示,但所选择的该不同侧可为与针对材料34所选择的一侧邻接的一侧。本发明的范围不受所选择的侧的限制,并且术语“不同侧”可意指不同于第一选定侧的多个侧面中的任一者。此外,尽管系统的形状被示出为方形,但形状可为任何几何上适合的形状。材料34和36被选择为使得其在系统30与导电液体(例如体液)接触时产生电势差。用于材料36的关注材料包括但不限于:Mg、Zn或其它电负性金属。如上文关于材料34所示,材料36可化学沉积在框架上、蒸镀到框架上、紧固到框架或构建在框架上。而且,粘附层可能是必要的,以帮助材料36(以及在需要时,帮助材料34)粘附到框架32。用于材料36的典型粘附层是Ti、TiW、Cr或类似材料。阳极材料和粘附层可通过物理气相沉积、电沉积或等离子体沉积来沉积。材料36可为约0.05到约500μm厚,例如约5到约100μm厚。然而,本发明的范围既不受任何材料的厚度的限制,也不受用以将材料沉积或紧固到框架32的工艺类型的限制。
根据所陈述的公开内容,材料34和36可为具有不同电化学电势的任何成对材料。另外,在活体内使用系统30的方面中,材料34和36可为能被吸收的维生素。更具体地说,材料34和36可由适合于系统30将要进行操作的环境的任何两种材料制成。举例来说,当与可摄取产品一起使用时,材料34和36为可摄取的具有不同电化学电势的任何成对材料。一个说明性实例包括当系统30与离子溶液(例如胃酸)接触时的例子。合适的材料不限于金属,且在某些方面中,成对的材料选自金属和非金属,例如,由金属(例如Mg)与盐(例如CuCl或CuI)组成的对。关于活性电极材料,具有适当不同的电化学电势(电压)和低界面阻力的任何配对的物质(金属、盐或嵌入化合物)是合适的。
关注的材料和配对包括但不限于以下表1中所报告的那些。在一个方面中,金属中的一者或两者可被掺杂有非金属,例如,以便增强在材料与导电液体形成接触时在所述材料之间形成的电势。在某些方面中,可用作掺杂剂的非金属包括但不限于:硫、碘等。在另一方面中,材料为作为阳极的碘化铜(CuI)和作为阴极的镁(Mg)。本发明的方面使用对人体无害的电极材料。
因此,当系统30与导电液体接触时,在材料34与36之间通过导电液体形成电流路径,图5中示出一个实例。控制装置38紧固到框架32且电耦合到材料34和36。控制装置38包括电子电路,例如能够控制并改变材料34与36之间的电导的控制逻辑。
在材料34与36之间形成的电势提供用于操作系统的电力以及产生穿过导电流体和系统的电流流动。在一个方面中,系统在直流电模式中操作。在替代方面中,系统控制电流的方向以使得电流方向以循环方式反转,类似于交流电。随着系统到达导电流体或电解液,其中流体或电解液成分由生理流体(例如,胃酸)提供,材料34与36之间的用于电流流动的路径在系统30外部完成;穿过系统30的电流路径由控制装置38控制。电流路径的完成允许电流流动,且接收器(未图示)又可检测到电流的存在并辨识到系统30已经激活且期望的事件正在发生或已经发生。关于图7到图12进一步描述此类接收器的说明性实例,如下文所描述。
在一个方面中,所述两种材料34和36在功能上类似于针对直流电源(例如电池)所需要的两个电极。导电液体充当用以完成电源所需要的电解液。所描述的完成的电源由系统30的材料34与36之间的电化学反应限定且由身体的流体启动。完成的电源可被视为是使用例如胃液、血液或其它体液的离子溶液或导电溶液和一些组织中的电化学电导的电源。另外,环境可为除了身体之外的某物,且液体可为任何导电液体。举例来说,导电流体可为盐水或金属基涂料。
在某些方面中,这两种材料通过额外的材料层来与周围环境屏蔽。因而,当屏蔽物溶解且这两种相异材料暴露于目标地点时,产生电势。
在某些方面中,完成的电源或电力供应是由活性电极材料、电解液和非活性材料(例如集电器、封装等)组成的。活性材料是具有不同电化学电势的任何成对材料。合适的材料不限于金属,且在某些方面中,配对材料选自金属和非金属,例如,由金属(例如Mg)与盐(例如CuI)组成的对。关于活性电极材料,具有适当不同的电化学电势(电压)和低界面阻力的任何配对的物质(金属、盐或嵌入化合物)是合适的。
多种不同材料可用作形成电极的材料。在某些方面中,电极材料被选择为在与目标生理地点(例如,胃部)接触后提供电压,所述电压足够驱动识别器的系统。在某些方面中,在电源的金属与目标生理地点接触后,由电极材料提供的电压为0.001V或更高,包括0.01V或更高,例如0.1V或更高,例如0.3V或更高;包括0.5伏或更高;包括1.0伏或更高,其中在某些方面中,电压在约0.001到约10伏的范围内,例如从约0.01到约10V。
再次参看图3,材料34和36提供电势以激活控制装置38。一旦控制装置38被激活或上电,控制装置38便可按唯一方式改变材料34与36之间的电导。通过改变材料34与36之间的电导,控制装置38能够控制穿过包围系统30的导电液体的电流的量值。这产生可由接收器(未图示)检测并测量的唯一电流签名,所述接收器可安置在身体内部或身体外。除了控制所述材料之间的电流路径的量值之外,使用不导电材料、膜或“裙部”来增加电流路径的“长度”,因此用以强化电导路径,如在2008年9月25日提交的发明名称为“In-BodyDevicewithVirtualDipoleSignalAmplification”的第12/238,345号的美国专利申请中所公开的,所述专利申请在2009年3月26日公开为2009-0082645A1,所述专利申请的全部内容以引用的方式并入本文中。或者,贯穿本文公开内容,术语“不导电材料”、“膜”和“裙部”可与术语“电流路径延长器”互换使用,而不会影响本文中的本发明方面和权利要求书的范围。分别在35和37处部分示出的裙部可与框架32相关联,例如,紧固到框架32。裙部的各种形状和配置被预期属于本发明的范围内。举例来说,系统30可全部或部分地由裙部包围,且裙部可沿着系统30的中心轴线安置或相对于中心轴线偏心安置。因此,如本文所要求的本发明的范围不受裙部的形状或大小限制。此外,在其它方面中,材料34和36可由一个裙部分开,所述裙部安置在材料34与36之间的任何限定的区域中。
现在参看图4,在另一方面中,图2A的系统12和图2B的系统22被更详细地示出为系统40。系统40包括框架42。框架42类似于图3的框架32。在系统40的这个方面中,可消化或可溶解材料44沉积在框架42的一侧的一部分上。在框架42的同一侧的不同部分处,沉积另一可消化材料46,使得材料44和46相异。更具体地说,材料44和46被选择为使得其在与导电液体(例如体液)接触时形成电势差。因此,当系统40与导电液体接触和/或部分地接触时,于是在材料44与46之间穿过导电液体形成电流路径,在图5中示出一个实例。控制装置48紧固到框架42且电耦合到材料44和46。控制装置48包括能够控制材料44与46之间的电导路径的一部分的电子电路。材料44和46由不导电裙部49分开。裙部49的各种实例在以下申请中公开:2009年4月28日提交的发明名称为“HIGHLYRELIABLEINGESTIBLEEVENTMARKERSANDMETHODSOFUSINGSAME”的第61/173,511号美国临时申请,所述美国临时申请还在2010年4月27日申请为第PCT/US10/32590号PCT申请且在2010年11月11日公开为WO2010/129288;2009年4月28日提交的发明名称为“INGESTIBLEEVENTMARKERSHAVINGSIGNALAMPLIFIERSTHATCOMPRISEANACTIVEAGENT”的第61/173,564号美国临时申请,所述美国临时申请还在2010年4月27日申请为第PCT/US10/32590号PCT申请且在2010年11月11日公开为WO2010/129288;以及2008年9月25日提交的发明名称为“IN-BODYDEVICEWITHVIRTUALDIPOLESIGNALAMPLIFICATION”的第12/238,345号美国申请,所述美国申请在2009年3月26日公开为第2009-0082645A1号美国公开;上述每个的全部公开内容以引用的方式并入本文中。
一旦控制装置48被激活或上电,控制装置48便可改变材料44与46之间的电导。因此,控制装置48能够控制穿过包围系统40的导电液体的电流幅值。如上文关于系统30所示,与系统40相关联的唯一电流签名可由接收器(未图示)检测以标示系统40的激活。接收器的说明性实例在图7到图12中找到,如下文所描述。为了增加电流路径的“长度”,改变裙部49的大小和/或特点。电流路径越长,接收器就可越容易检测电流。
现在参看图5,图3的系统30被示出为处于激活状态且与导电液体接触。系统30通过接地触点52来接地。举例来说,当系统30与导电流体接触时,导电流体提供接地。系统30还包括传感器模块74,其关于图6更详细地描述。在材料34到材料36之间且穿过与系统30接触的导电流体而形成离子或电流路径50。在材料34与36之间形成的电势是通过材料34/36与导电流体之间的化学反应来形成的。
系统30还包括单元75。单元75包括启动通信功能的方面,且根据本发明的各种方面,可充当接收器、发送器或收发器中的任一者。因此,在系统30外部的另一装置(例如,手机、植入式装置、附接到用户身体的装置、或放置在用户皮肤下的装置)可例如通过单元75向系统30通信、从系统30通信或进行两者。单元75还电连接到材料34和36。根据本发明的一个方面,在系统30外部的任何装置可利用穿过包围系统30的环境的电流流动来与单元75或控制模块38通信。举例来说,附接到用户身体的贴片或接收器、正由用户保持的手机或装置、或者植入式装置,是可产生穿过用户身体的电流签名的装置的实例。电流签名可包括编码在其中的信息。电流签名由系统30利用单元75或控制模块38来检测,且被解码以允许从系统30外部的装置到系统30的通信。因而,外部装置可无线地或通过跨导来将信号发送到控制系统30的激活的单元75。
根据本发明的一个方面,单元75还可直接地或通过传感器模块74测量周围环境,以确定系统30是否应由于不利的环境条件而解除激活。举例来说,单元75可包括阻抗测量单元75a,所述阻抗测量单元75a能够测量系统30周围的环境的阻抗。单元75a通过将电压传输或施加到一个输出端子(例如材料34)来测量阻抗。接着单元75a测量阻抗(使用图3的电阻31)。在具有已知量的电阻和已知的电压的情况下,单元75a能够确定周围环境的阻抗。在接收器处接收的信号与系统30的电流输出成正比。如果在系统30的输出端子处添加可变电阻(例如电阻31),那么系统30的电流输出将与1/(R+Z)成比例,其中R是可变电阻器的值且Z是系统30周围的溶液或胃部环境的局部阻抗。因此,所检测到的信号将等于:
Vreceievd=k/(R+Z)
系统30可被设计有可变电阻器,在传输期间其在2个或2个以上的电平之间循环。这带来将根据以上等式变化的接收信号。在被检测到时,所述信号用以产生线性曲线以匹配:
1/Vreceived相对R
并且确定斜率和截距。斜率将具有值1/k且截距将具有值Z/k。这允许独立于从系统30得到的实际电压或电流来确定k和系统30的局部阻抗二者,因为可变电阻器的值从设计参数中得知。
阻抗测量可用以监视患者的水化状态、药品的存在、胃肠蠕动/波动、胃部通过时间、某些类型的组织(肿瘤)或出血的存在。阻抗测量也是用于监视系统30的性能的有用诊断工具。举例来说,如果周围环境的阻抗妨碍有效通信,那么系统30可被去激活或延迟激活。根据本发明的一个方面,单元75向控制装置38发送信号。作为响应,控制装置38可改变材料34与36之间的电导以及因此阻抗,以降低材料34和36与周围环境之间的化学反应速率,且进而促使系统30达到去激活模式、状态或条件。以此方式,尽管存在某种化学反应,但其足够低以保存系统30的电力以供稍后使用,同时仍允许对附近环境的感测和测量操作。
如果环境的条件改变为变得对通信有利,如由对环境的测量所确定的,那么单元75向控制装置38发送信号以改变材料34与36之间的电导来允许利用系统30的电流签名进行通信。因此,如果系统30已经被去激活且环境的阻抗适合于通信,那么系统30可被再次激活。
如果环境的条件改变为变得对通信有利,如由对环境的测量所确定的,那么单元75向控制装置38发送信号以改变材料34与36之间的电导来允许利用系统30的电流签名进行通信。因此,如果系统30已经被去激活且环境的阻抗适合于通信,那么系统30可被再次激活。
现在参看图5A,图5A示出材料34的表面的分解图。在一个方面中,材料34的表面不是平坦的,而是不规则表面。所述不规则表面增加材料的表面面积,且因此增加与导电流体形成接触的面积。在一个方面中,在材料34的表面处,材料34与周围导电流体之间存在电化学反应,使得与导电流体交换物质。此处所使用的术语“物质”包括可作为在材料34上发生的电化学反应的一部分而添加到导电流体或从导电流体移除的任何离子或非离子种类。一个实例包括材料是CuCl且当与导电流体接触时CuCl转换为Cu金属(固体)且Cl-被释放到溶液中的例子。正离子到导电流体中的流动由电流路径50描绘。负离子在相反方向上流动。以类似方式,存在涉及材料36的电化学反应,其致使从导电流体释放或移除离子。在这个实例中,负离子在材料34处的释放以及正离子通过材料36的释放通过由控制装置38控制的电流流动而彼此相关。反应速率以及因此离子发射速率或电流由控制装置38控制。控制装置38可通过改变其内部电导来增加或降低离子流动的速率,这改变阻抗以及因此改变材料34和36处的电流流动和反应速率。通过控制反应速率,系统30可在离子流动中编码信息。因此,系统30利用离子发射或流动来编码信息。
控制装置38可改变离子流动或电流的持续时间,同时保持电流或离子流动的量值接近恒定,这类似于在频率被调制且幅度恒定时。而且,控制装置38可改变离子流动速率的等级或电流流动的量值,同时保持持续时间接近恒定。因此,利用在持续时间上改变以及改变速率或量值的各种组合,控制装置38在电流或离子流动中编码信息。举例来说,控制装置38可使用但不限于以下技术中的任一者,包括二进制相移键控(PSK)、频率调制、振幅调制、开关键控和具有开关键控的PSK。
如上文所示,本文中所公开的各种方面(例如图3的系统30和图4的系统40)包括作为控制装置38或控制装置48的一部分的电子组件。可存在的组件包括但不限于:逻辑和/或存储器元件、集成电路、电感器、电阻器和用于测量各种参数的传感器。每一组件可紧固到框架和/或另一组件。支撑件的表面上的组件可按任何便利配置来布置。在固体支撑件的表面上存在两个或两个以上的组件的情况下,可提供互连件。
如上文所示,系统(例如控制装置30和40)控制相异材料之间的电导以及因此控制离子流动或电流的速率。通过以特定方式改变电导,系统能够在离子流动和电流签名中编码信息。离子流动或电流签名用以唯一地识别特定系统。另外,系统30和40能够产生各种不同的唯一图案或签名,因此提供额外信息。举例来说,基于第二电导改变图案的第二电流签名可用以提供额外信息,所述信息可与物理环境相关。为了进一步说明,第一电流签名可为维持芯片上的振荡器的非常低的电流状态,且第二电流签名可为至少是与第一电流签名相关联的电流状态的至少十倍的电流状态。
现在参看图6,示出控制装置38的框图表示。控制装置38包括控制模块62、计数器或时钟64、以及存储器66。另外,装置38被示出为包括传感器模块72以及传感器模块74,所述传感器模块74在图5中提及。控制模块62具有电耦合到材料34的输入68以及电耦合到材料36的输出70。控制模块62、时钟64、存储器66和传感器模块72/74还具有电力输入(一些未图示)。当系统30与导电流体接触时,用于这些组件中的每一者的电力由材料34和36与导电流体之间的化学反应所产生的电势来供应。控制模块62通过改变系统30的整体阻抗的逻辑来控制电导。控制模块62电耦合到时钟64。时钟64将时钟周期提供到控制模块62。基于控制模块62的被编程的特性,当一定数目的时钟周期已经过去时,控制模块62改变材料34与36之间的电导特性。重复进行这个循环,进而控制装置38产生唯一的电流签名特性。控制模块62还电耦合到存储器66。时钟64和存储器66两者由材料34与36之间形成的电势供电。
控制模块62还电耦合到传感器模块72和74并且与之通信。在所示出的方面中,传感器模块72是控制装置38的一部分,且传感器模块74是单独的组件。在替代的方面中,传感器模块72和74中的任一者可在没有另一者的情况下被使用,本发明的范围不受传感器模块72或74的结构或功能位置限制。另外,系统30的任何组件可在功能上或结构上移动、组合或重新安置,而不限制本发明所要求保护的范围。因此,有可能具有单个结构,例如处理器,其被设计为执行所有以下模块的功能:控制模块62、时钟64、存储器66和传感器模块72或74。另一方面,使这些功能组件中的每一者定位在电链接且能够通信的独立结构中也在本发明的范围内。
再次参看图6,传感器模块72或74可包括以下传感器中的任一者:温度、压力、pH值和导电性。在一个方面中,传感器模块72或74从环境中收集信息且将模拟信息传送到控制模块62。控制模块接着将模拟信息转换为数字信息,且在电流流动中或在产生离子流动的物质转移的速率中编码所述数字信息。在另一方面中,传感器模块72或74从环境中收集信息且将模拟信息转换为数字信息,接着将数字信息传送到控制模块62。在图5所示的方面中,传感器模块74被示出为电耦合到材料34和36以及控制装置38。在另一方面中,如图6所示,传感器模块74在连接78处电耦合到控制装置38。连接78充当传感器模块74的电力供应源以及传感器模块74与控制装置38之间的通信信道这两者。
现在参看图5B,系统30包括连接到材料39的pH传感器模块76,所述pH传感器模块76根据正在执行的特定类型的感测功能来选择。pH传感器模块76还连接到控制装置38。材料39通过不导电阻挡层55来与材料34电隔离。在一个方面中,材料39是铂。在操作中,pH传感器模块76利用材料34/36之间的电势差。pH传感器模块76测量材料34与材料39之间的电势差,且记录所述值以供稍后比较。pH传感器模块76还测量材料39与材料36之间的电势差,且记录所述值以供稍后比较。pH传感器模块76利用电势值来计算周围环境的pH值。pH传感器模块76将信息提供给控制装置38。控制装置38改变产生离子转移的物质转移的速率和电流流动以在离子转移中编码与pH值相关的信息,所述信息可由接收器(未图示)检测。因此,系统30可确定与pH值相关的信息并将其提供给在环境外部的源。
如上文所示,可预先编程控制装置38以输出预定义的电流签名。在另一方面中,系统可包括接收器系统,所述接收器系统可在系统被激活时接收编程信息。在另一方面(未图示)中,开关64和存储器66可组合成一个装置。
在环境外部的源的实例包括各种接收器及其类似物。在接收器(本文中有时称为“信号接收器”)的一个实例中,可采用两种或两种以上的不同解调协议来解码给定的接收信号。在一些例子中,可采用相干解调协议和差分相干解调协议两者。图7提供根据本发明的一个方面接收器可如何实施相干解调协议的功能框图。应注意到,图7中仅示出接收器的一部分。图7说明一旦确定载波频率(以及向下混频到载波偏移的载波信号)便将信号向下混频到基带的过程。在混频器2223处将载波信号2221与第二载波信号2222混频。应用具有恰当带宽的窄低通滤波器2220来减少界外噪声效应。在功能块2225处根据本发明的相干解调方案来发生解调。确定复数信号的展开相位2230。可应用选择性的第三混频器级,其中使用相位演变来估计所计算的载波频率与真实的载波频率之间的频率差异。接着在块2240处利用数据包的结构来确定BPSK信号的编码区的开始。主要使用同步标头的存在来确定数据包的开始边界,所述同步标头呈现为复数解调信号的振幅信号中的FM边沿。一旦确定数据包的开始点,便在块2250处在IQ平面和标准位识别上旋转信号并且最终在块2260处解码所述信号。
除了解调之外,穿体通信模块可包括前向误差校正模块,所述模块提供额外增益来抗击来自其它不需要的信号和噪声的干扰。所关注的前向误差校正功能模块包括公开为WO2008/063626的第PCT/US2007/024225号PCT申请中所描述的那些模块,所述申请的公开内容以引用的方式并入本文中。在一些例子中,前向误差校正模块可采用例如里德-索罗门(Reed-Solomon)、格雷(Golay)、汉明(Hamming)、BCH和涡轮(Turbo)协议等的任何便利的协议来识别和校正(在界限内)解码误差。
在另一实例中,接收器包括信标模块,如图8的功能框图中所示。图8中概述的方案概述了一种用于识别有效信标的技术。传入信号2360表示由电极接收、由高频信令链(其包括载波频率)带通滤波(例如从10KHz到34KHz)、且从模拟转换到数字的信号。接着在块2361处对信号2360进行抽取且在混频器2362处在标称驱动频率(例如12.5KHz、20KHz等)对信号2360进行混频。在块2364处对所得信号进行抽取且在块2365处进行低通滤波(例如5KHzBW)以产生向下混频到载波偏移的载波信号——信号2369。信号2369进一步由块2367处理(快速傅里叶变换且接着检测两个最强峰值)以提供真实载波频率信号2368。这种协议允许准确地确定所发送的信标的载波频率。
图9提供根据本发明的一方面的信号接收器的集成电路组件的功能框图。在图9中,接收器2700包括电极输入2710。电耦合到电极输入2710的是穿体导电通信模块2720和生理感测模块2730。在一个方面中,穿体导电通信模块2720被实施为高频(HF)信号链,且生理感测模块2730被实施为低频(LF)信号链。还示出了CMOS温度感测模块2740(用于检测周围温度)和3轴加速计2750。接收器2700还包括处理引擎2760(例如,微控制器和数字信号处理器)、非易失性存储器2770(用于数据存储)和无线通信模块2780(用于将数据发送到另一装置,例如在数据上载动作中)。
图10提供根据本发明的一个方面的被配置为实施图9中所描绘的接收器的功能框图的电路的较详细框图。在图10中,接收器2800包括电极e1、e2和e3(2811、2812和2813),所述电极e1、e2和e3(2811、2812和2813)例如接收由IEM导电性发送的信号和/或感测关注的生理参数或生物标示器。电极2811、2812和2813所接收的信号由多路复用器2820进行多路复用,所述多路复用器2820电耦合到电极。
多路复用器2820电耦合到高带通滤波器2830和低带通滤波器2840两者。高频信号链和低频信号链提供可编程增益以覆盖期望的层级或范围。在这个特定方面中,高带通滤波器2830使10KHz到34KHz带中的频率通过,而滤出来自带外频率的噪声。这个高频带可变化,且可包括(例如)3KHz到300KHz的范围。通过的频率接着由放大器2832放大,之后由转换器2834转换为数字信号以输入到高功率处理器2880(示出为DSP)中,所述高功率处理器2880电耦合到高频信号链。低带通滤波器2840被示出为使0.5Hz到150Hz的范围内的较低频率通过,而滤出带外频率。所述频带可变化,且可包括(例如)低于300Hz的频率,例如低于200Hz,包括低于150Hz。通过的频率信号由放大器2842放大。还示出了加速计2850,其电耦合到第二多路复用器2860。多路复用器2860将来自加速计的信号与来自放大器2842的放大信号进行多路复用。经多路复用的信号接着由转换器2864转换为数字信号,所述转换器2864还电耦合到低功率处理器2870。在一个方面中,数字加速计(例如由AnalogDevices公司制造的数字加速计)可代替加速计2850来实施。可通过使用数字加速计来实现各种优点。举例来说,因为数字加速计产生已经呈数字格式的信号,所以数字加速计可旁路转换器2864且电耦合到低功率微控制器2870——在所述情况下,将不再需要多路复用器2860。而且,数字信号可被配置为在检测到运动时将其自身接通,从而进一步保存电力。另外,可实施连续步骤计数。数字加速计可包括FIFO缓冲器来帮助控制发送到低功率处理器2870的数据流。举例来说,数据可缓冲在FIFO中直到满为止,在满时可触发处理器以从闲置状态唤醒且接收所述数据。举例来说,低功率处理器2870可为来自TexasInstruments公司的MSP430微控制器。接收器2800的低功率处理器2870维持闲置状态,如之前陈述的,这需要最小的电流消耗,例如,10.mu.A或更少,或1.mu.A或更少。举例来说,高功率处理器2880可为来自TexasInstruments公司的VC5509数字信号处理器。高功率处理器2880在活动状态期间执行信号处理动作。如之前陈述的,这些动作需要比闲置状态更大的电流量,例如30.mu.A或更多的电流,例如50.mu.A或更多,且举例来说,可包括例如扫描导电性发送的信号、在接收到时处理导电性发送的信号、获得和/或处理生理数据等动作。
图10中还示出快闪存储器2890,其电耦合到高功率处理器2880。在一个方面中,快闪存储器2890可电耦合到可提供更好功率效率的低功率处理器2870。无线通信元件2895被示出为电耦合到高功率处理器2880,且可包括(例如)BLUETOOTH.TM.无线通信收发器。在一个方面中,无线通信元件2895电耦合到高功率处理器2880。在另一方面中,无线通信元件2895电耦合到高功率处理器2880和低功率处理器2870。此外,无线通信元件2895可实施为具有其自己的电力供应,使得其可独立于接收器的其它组件来接通和断开,例如,通过微处理器。
在(例如)闲置状态的情况下,以下段落提供根据本发明的一个方面的图10所示的接收器组件在接收器的各种状态期间的实例配置。应理解,可根据期望的应用来实施替代性配置。举例来说,在闲置状态下,接收器吸收最少的电流。接收器2800被配置为使得低功率处理器2870处于不活动状态(例如,闲置状态)且高功率处理器2880处于不活动状态(例如闲置状态),且与外围电路相关的电路块及其在各种活动状态期间所需要的电力供应保持断开(例如,无线通信模块2895和模拟前端)。举例来说,低功率处理器可使32KHz振荡器活动且可消耗几.mu.A电流或更少,包括0.5.mu.A或更少。在闲置状态下,低功率处理器2870可(例如)等待信号转变为活动状态。信号可以在外部,例如中断,或由装置的外围设备中的一者(例如定时器)在内部产生。在高功率处理器的闲置状态期间,高功率处理器可(例如)关闭32KHz钟表晶体。举例来说,高功率处理器可等待信号转变为活动状态。当接收器处于嗅探状态时,低功率处理器2870处于闲置状态,且高功率处理器2880处于闲置状态。另外,与嗅探功能所需要的模拟前端(包括A/D转换器)相关的电路块接通(换句话说,高频信号链)。如之前陈述,信标信号模块可实施各种类型的嗅探信号来实现低功率效率。在检测到发送的信号后,可进入更高功率解调和解码状态。当接收器处于解调和解码状态时,低功率处理器2870处于活动状态,且高功率处理器2880处于活动状态。举例来说,高功率处理器2880可从具有给予装置108MHz时钟速度的基于PLL的时钟倍频器的12MHz或附近晶体振荡器运行。举例来说,在活动状态期间,低功率处理器2870可关闭在1MHz到20MHz的范围内的内部R-C振荡器,且消耗在250到300uA/MHz时钟速度的范围内的电力。活动状态允许进行处理以及可跟随的任何发送。所需要的发送可触发无线通信模块从断开循环到接通。
当接收器处于收集ECG和加速计状态时,与加速计和/或ECG信号调节链相关的电路块接通。高功率处理器2880在收集期间处于闲置状态,且在处理和发送期间处于活动状态(例如,从具有给予装置108MHz时钟速度的基于PLL的时钟倍频器的12MHz或附近晶体振荡器运行)。低功率处理器2870在这种状态期间处于活动状态,且可关闭在1MHz到20MHz的范围内的内部R-C振荡器,且消耗在250到300uA/MHz时钟速度的范围内的电力。
低功率处理器(例如,图10所示的MSP)和高功率处理器(例如,图10所示的DSP)可利用任何便利的通信协议来彼此通信。在一些例子中,这两个元件在存在时经由串行外围接口总线(下文中称为“SPI总线”)来彼此通信。以下描述内容描述了被实施为允许高功率处理器和低功率处理器沿着SPI总线通信且来回发送消息的信令和消息接发方案。针对以下对处理器之间的通信的描述,分别使用“LPP”和“HPP”来代替“低功率处理器”和“高功率处理器”,以与图10保持一致。然而,该论述可适用于除图10所示的处理器之外的其它处理器。
图11提供与高频信号链相关的根据本发明的一方面的接收器中的硬件的框图的图。在图11中,接收器2900包括电耦合到多路复用器2920的接收器探针(例如,呈电极2911、2912和2913的形式)。还示出高通滤波器2930和低通滤波器2940以提供消除任何带外频率的带通滤波器。在所示出的方面中,提供10KHz到34KHz的带通以使落入所述频带内的载波信号通过。实例的载波频率可包括但不限于12.5KHz和20KHz。可存在一个或多个载波。另外,接收器2900包括模数转换器2950,例如,在500KHz下采样。此后可由DSP处理数字信号。在这个方面中示出DMA至DSP单元2960,其将数字信号发送到用于DSP的专用存储器。直接的存储器存取提供允许DSP的其余部分保持处于低功率模式的益处。
图12中示出包括接收器的系统的实例。在图12中,系统3500包括药物合成物3510,所述药物合成物3510包括可摄取装置,例如可摄取事件标示器“IEM”。系统3500中还存在信号接收器3520。信号接收器3520被配置为检测从IEM3510的识别器发射的信号。信号接收器3520还包括生理感测能力,例如ECG和运动感测能力。信号接收器3520被配置为将数据发送到患者的外部装置或PDA3530(例如智能电话或其它具无线通信功能的装置),外部装置或PDA3530又将数据发送到服务器3540。服务器3540可根据需要来配置,例如,以提供针对患者的许可。举例来说,服务器3540可被配置为允许家庭护理者3550参与患者的治疗方案,例如,经由允许家庭护理者3550监视服务器3540所产生的警报和趋势的接口(例如网络接口),并且向患者提供回支持,如由箭头3560所指示。服务器3540还可被配置为将响应直接提供给患者,例如,以患者警报、患者激励等的形式,如由箭头3565所指示,所述响应经由PDA3530中继到患者。服务器3540还可与健康护理专业人员(例如,RN、内科医生)3555交互,健康护理专业人员可使用数据处理算法来获得患者健康和配合度量度,例如健康指数总结、警报、跨患者基准等,且向患者提供回所通知的临床沟通和支持,如由箭头3580所指示。
除了以上组件之外,系统30还可包括一个或其它电子组件。所关注的电组件包括但不限于:额外的逻辑和/或存储器元件,例如,呈集成电路的形式;电力调节装置,例如,电池、燃料电池或电容器;传感器、激励器等;信号发送元件,例如,呈天线、电极、线圈等的形式;无源元件,例如,电感器、电阻器等。
在某些方面中,可摄取电路包括涂层。该涂层的用途可变化,例如,用以在处理期间、在储存期间或甚至在摄取期间保护电路、芯片和/或电池或者任何组件。在这些例子中,可包括位于电路顶部的涂层。还关注的是设计为在储存期间保护可摄取电路但在使用期间立即溶解的涂层。举例来说,在与水流体(例如,胃液)或如上文所提及的导电流体接触后溶解的涂层。还关注的是用来允许使用原本会损坏装置的某些组件的处理步骤的保护性处理涂层。举例来说,在生产顶部和底部上沉积有相异材料的芯片的方面中,需要将产品切成块。然而,切块过程可能会划掉所述相异材料,并且还可能涉及会导致相异材料脱落或溶解的液体。在这些例子中,可采用材料上的保护性涂层,其防止在处理期间与组件形成机械或液体接触。可溶解涂层的另一用途可被提供来延迟装置的激活。举例来说,可采用置于相异材料上且在与胃液接触后花费特定时间周期(例如,五分钟)来溶解的涂层。涂层还可为环境敏感性涂层,例如,温度或pH敏感性涂层,或提供用于以受控形式溶解且允许在需要时激活装置的其它化学敏感性涂层。在胃部中继续存在但在肠道中溶解的涂层也是受关注的,例如,在需要延迟激活直到装置离开胃部为止的情况下。此类涂层的实例是在低pH下不能溶解但在较高pH下变得能溶解的聚合物。还关注的是药物配方保护性涂层,例如,凝胶胶囊液体保护性涂层,其防止电路由凝胶胶囊的液体激活。
所关注的识别器包括类似于电源的电极(例如,阳极和阴极)来起作用的两种相异电化学材料。提及电极或阳极或阴极在本文中仅仅用作说明性实例。本发明的范围不受所使用的名称限制,而是包括在两种相异材料之间形成电势的方面。因此,在提及电极、阳极或阴极时,意在提及在两种相异材料之间形成的电势。
当材料暴露且与体液、例如胃酸或其它类型的流体(单独地或与干燥导电介质前体组合地)形成接触时,由于这两种电极材料所遭受的相应氧化和还原反应而在电极之间产生电势差,即电压。进而可产生伏打电池或电池。因此,在本发明的多个方面中,此类电力供应被配置为使得当这两种相异材料暴露于目标地点(例如,胃部、消化道等)时,产生电压。
在某些方面中,金属中的一种或两种可被掺杂有非金属,例如,以增强电池的电压输出。在某些方面中可用作掺杂剂的非金属包括但不限于:硫、碘等。
应理解,本发明不限于本文中所描述的特定实施例或方面,因而可变化。还应理解,本文中所使用的术语仅出于描述特定方面的目的,不意在具限制性,因为本发明的范围将仅由所附权利要求书限定。
在提供值的范围的情况下,应理解,在所述范围的上限与下限之间的每个居间值(精确到下限的单位的十分之一,除非上下文清楚地另有规定)以及那个所陈述范围内的任何其它所陈述值或居间值均涵盖在本发明内。这些较小范围的上限和下限可被独立地包括在所述较小范围内,且也涵盖在本发明内,服从所陈述范围中的任何特殊排除的界限。在所陈述的范围包括所述界限中的一者或两者的情况下,排除那些所包括的界限中的任一者或两者的范围也包括在本发明中。
除非另有定义,否则本文中所使用的所有技术和科学术语均具有本发明所属的领域的技术人员通常所理解的相同意思。尽管类似或等效于本文所描述的方法和材料的任何方法和材料也可用于实践或测试本发明,但现在描述代表性说明性方法和材料。
尽管有权利要求书,但是本发明还参考以下条款:
1.一种用于通信的装置,所述装置包括在导电流体中起作用的电路和组件,所述装置是可摄取和/或可消化的,所述装置包括:
通信单元,所述通信单元包括:
支撑结构;
部分电源,其具有沉积到所述支撑结构上的第一材料;以及
第二材料,其沉积到所述支撑结构上且与所述第一材料电隔离,其中所述第一材料和所述第二材料被选择为在与导电流体接触时具有电势差,以提供用以激活所述装置的电力;
控制模块,其与所述支撑结构相关联,且电连接到所述第一材料和所述第二材料以用于控制所述第一材料与所述第二材料之间的电导,使得所述第一材料与所述第二材料之间的在电导上的变化改变所述装置的电流签名且由此在所述电流签名中编码信息;以及
单元,其与所述控制模块通信且与所述支撑结构相关联,以至少从外部源接收信号或将信号发送到所述外部源。
2.根据条款1所述的装置,进一步包括限定空腔的密封壳体,其中所述通信单元安置在所述空腔内。
3.根据条款2所述的装置,进一步包括在所述空腔内的释放材料,其中所述单元产生释放命令以促使所述释放材料膨胀并打开所述密封壳体。
4.根据条款2或3中任一条款所述的装置,其中所述单元包括:从所述单元向外延伸以穿透所述密封壳体的壁部分且允许所述通信单元与所述密封壳体分开的机构。
5.根据条款1到4中任一条款所述的装置,其中所述单元包括杆,所述杆以机械方式激活以戳破所述密封壳体的壁部分、且促使所述密封壳体打开并允许所述通信单元与所述导电流体形成接触。
6.根据条款1到5中任一条款所述的装置,其中所述单元测量与直接包围所述通信单元的环境相关联的特性。
7.根据条款1到6中任一条款所述的装置,进一步包括释放设备,所述释放设备紧固到所述支撑结构且与所述单元通信,其中所述释放设备从所述单元接收释放命令且响应于所述信号促使所述装置暴露于所述导电流体。
8.根据条款2到7中任一条款所述的装置,其中所述空腔包括与所述释放设备通信的材料,且所述释放设备促使所述材料在所述空腔内膨胀,使得所述密封壳体裂开。
9.根据条款7所述的装置,其中所述释放设备包括膨胀材料,所述膨胀材料在所述空腔内膨胀以促使所述密封壳体裂开。
10.根据条款7所述的装置,其中所述释放设备包括杆,所述杆以机械方式在所述密封壳体的空腔内从所述释放设备延伸以促使所述密封壳体裂开。
11.根据条款1到10中任一条款所述的装置,其中在所述装置与所述导电流体形成接触之后,在所述单元处接收到的信号被发送到所述控制模块,且所述控制模块通过改变所述第一材料与所述第二材料之间的电导来降低所述装置产生的电力。
12.根据条款1到11中任一条款所述的装置,其中所述单元将与所述装置的环境相关联的信息发送到外部源。
13.根据条款1到12中任一条款所述的装置,其中所述单元包括阻抗测量单元,所述阻抗测量单元在一个输出处耦合到所述第一材料且在另一输出处耦合到所述第二材料,以测量周围环境的阻抗且控制所述装置。
14.根据条款13所述的装置,其中所述单元将阻抗信号发送到所述控制模块,且所述控制模块在接收到所述阻抗信号后改变所述第一材料与所述第二材料之间的电导,优选地其中所述测量单元将所述阻抗信号发送到所述控制模块以向所述控制模块指示所述周围环境的阻抗低于指定的值且所述装置可被激活。
15.根据前述条款中任一条款所述的装置,其中所述单元从外部源接收去激活信号且将信息传送到所述控制模块,使得所述控制模块改变所述第一材料与所述第二材料之间的电导,以便防止在所述第一材料与第二材料之间产生电流流动且由此去激活所述装置。
16.根据前述条款中任一条款所述的装置,进一步包括限定空腔的密封壳体,其中所述通信单元安置在所述空腔内且进一步包括在所述空腔内的电活性基体,其中所述单元产生电压以促使所述电活性基体膨胀且打开所述密封壳体。
17.根据前述条款中任一条款所述的装置,进一步包括药物产品。
18.根据条款17所述的装置,其中在所述药物产品的摄取和/或所述装置的激活和/或所述药物产品与导电流体接触时在所述电流签名中编码信息。
19.一种系统,其包括根据条款1到18中任一条款所述的装置和用于从所述装置接收通信的接收器。
20.一种将根据前述条款中任一条款所述的装置或系统用于指示患者何时已经服用药物的用途。
本说明书中所引用的所有公开案和专利以引用的方式并入本文中,如同每一单独公开案或专利被特定且个别地指明以引用的方式并入,且以引用的方式并入本文中以公开并描述引用所述公开案所结合的方法和/或材料。任何公开案的引用是为了公开在申请日期之前的公开案,且不应解释为承认本发明因为在先发明而无权先于所述公开案。另外,所提供的公开日期可能不同于实际公开日期,所述实际公开日期可能需要独立确认。
请注意,如本文中和所附权利要求书中所使用,单数形式“一”、“一个”和“所述”包括复数对象,除非上下文清楚地另有规定。进一步注意到,可起草权利要求书来排除任何任选的元件。因而,这个陈述希望充当用于结合权利要求元素的叙述使用例如“单独地”、“仅仅”等排他性术语或使用“负面”限制的前置基础。
如所属领域的技术人员在阅读本公开后将容易明白,本文中所描述和说明的单独方面中的每一者具有可在不脱离本发明的范围或精神的情况下容易与其它若干方面中的任一者的特征分离或组合的离散组件和特征。所叙述的任何方法可按所叙述的事件的次序或按逻辑上可能的任何其它次序来实行。
虽然已经出于使理解清楚的目的而借助于说明和实例来以某种细节描述了前述发明,但所属领域的技术人员鉴于本发明的教示而易于明白,在不脱离所附权利要求书的精神或范围的情况下,可对本发明做出某些改变和修改。
因而,前述内容仅仅说明本发明的原理。将了解,所属领域的技术人员将能够构想出各种布置,虽然本文中未明确地描述或示出,但所述各种布置体现本发明的原理且包括在其精神和范围内。此外,本文中所叙述的所有实例和条件语言主要希望帮助读者理解本发明的原理和发明人贡献来促进此项技术的概念,且应解释为不限于这些明确叙述的实例和条件。此外,本文中叙述本发明的原理、观点和方面以及其特定实例的所有陈述希望包括其结构和功能等效物两者。另外,希望此类等效物包括当前已知的等效物以及将来开发的等效物,即,不管结构如何而执行相同功能的所开发的任何元件。因此,本发明的范围不希望限于本文中所示出和描述的示范性方面。而是,本发明的范围和精神由所附权利要求书体现。

Claims (9)

1.一种用于通信的装置,所述装置包括:
第一通信单元,其包括:
支撑结构;
部分电源,其包括:
第一材料,其沉积到所述支撑结构上;以及
第二材料,其沉积到所述支撑结构上且与所述第一材料电隔离,其中所述第一材料和所述第二材料被选择为在与导电流体接触时具有电势差,以提供用以激活所述装置的电力;
控制模块,其与所述支撑结构相关联,且电连接到所述第一材料和所述第二材料,且被配置为控制所述第一材料与所述第二材料之间的电导,其中,当所述第一材料和所述第二材料与所述导电流体接触时,所述第一材料与所述第二材料之间的在电导上的变化改变电流签名,以由此在所述电流签名中编码信息;
第二通信单元,其与所述控制模块通信且与所述支撑结构相关联,以至少从外部源接收信号或将信号发送到外部源;
限定空腔的密封壳体,其中所述第一通信单元和所述第二通信单元安置在所述空腔内;以及
在所述空腔内的释放材料,其中所述第二通信单元产生释放命令以促使所述释放材料膨胀并打开所述密封壳体,以将所述第一通信单元释放到所述导电流体中以激活所述部分电源且由此激活所述装置。
2.根据权利要求1所述的装置,其中所述第二通信单元包括:从所述第二通信单元向外延伸以穿透所述密封壳体的壁部分从而允许所述第一通信单元与所述密封壳体分开的机构。
3.一种用于通信的装置,所述装置包括:
第一通信单元,其包括:
支撑结构;
部分电源,其包括:
第一材料,其沉积到所述支撑结构上;以及
第二材料,其沉积到所述支撑结构上且与所述第一材料电隔离,其中所述第一材料和所述第二材料被选择为在与导电流体接触时具有电势差,以提供用以激活所述装置的电力;
控制模块,其与所述支撑结构相关联,且电连接到所述第一材料和所述第二材料,且被配置为控制所述第一材料与所述第二材料之间的电导,其中,当所述第一材料和所述第二材料与所述导电流体接触时,所述第一材料与所述第二材料之间的在电导上的变化改变电流签名,以由此在所述电流签名中编码信息;
第二通信单元,其与所述控制模块通信且与所述支撑结构相关联,以至少从外部源接收信号或将信号发送到外部源,其中所述第二通信单元包括杆,所述杆以机械方式激活以戳破密封壳体的壁部分、且促使所述密封壳体打开并允许所述第一通信单元与所述导电流体形成接触;以及
限定空腔的所述密封壳体,其中所述第二通信单元安置在所述空腔内以将所述第一通信单元释放到所述导电流体中以激活所述部分电源且激活所述装置。
4.一种用于通信的装置,所述装置包括:
第一通信单元,其包括:
支撑结构;
部分电源,其包括:
第一材料,其沉积到所述支撑结构上;以及
第二材料,其沉积到所述支撑结构上且与所述第一材料电隔离,其中所述第一材料和所述第二材料被选择为在与导电流体接触时具有电势差,以提供用以激活所述装置的电力;
控制模块,其与所述支撑结构相关联,且电连接到所述第一材料和所述第二材料,且被配置为控制所述第一材料与所述第二材料之间的电导,其中,当所述第一材料和所述第二材料与所述导电流体接触时,所述第一材料与所述第二材料之间的在电导上的变化改变电流签名,以由此在所述电流签名中编码信息;
第二通信单元,其与所述控制模块通信且与所述支撑结构相关联,以至少从外部源接收信号或将信号发送到外部源,其中所述第二通信单元测量与直接包围所述第一通信单元的环境相关联的至少一个特性;以及
释放设备,所述释放设备紧固到所述支撑结构且与所述第二通信单元通信,其中所述第二通信单元被配置为提供释放命令至所述释放设备,并且其中所述释放设备被配置为响应于所述释放命令来促使所述装置暴露于所述导电流体,以将所述第一通信单元释放到所述导电流体中以激活所述部分电源且由此激活所述装置。
5.根据权利要求4所述的装置,还包括限定空腔的密封壳体,其中所述第一通信单元和所述第二通信单元安置在所述空腔内,并且其中所述空腔包括与所述释放设备通信的材料,且在接收到所述释放命令时所述释放设备促使所述材料在所述空腔内膨胀,使得所述密封壳体裂开从而促使所述装置暴露于所述导电流体。
6.根据权利要求4所述的装置,还包括限定空腔的密封壳体,其中所述第一通信单元和所述第二通信单元安置在所述空腔内,并且其中所述释放设备包括膨胀材料,所述膨胀材料在所述空腔内膨胀,在接收到所述释放命令时促使所述密封壳体裂开从而促使所述装置暴露于所述导电流体。
7.根据权利要求4所述的装置,还包括限定空腔的密封壳体,其中所述第一通信单元和所述第二通信单元安置在所述空腔内,并且其中所述释放设备包括杆,所述杆以机械方式在所述密封壳体的所述空腔内从所述释放设备延伸,当接收到所述释放命令时促使所述密封壳体裂开且促使所述装置暴露于所述导电流体。
8.一种用于通信的装置,所述装置包括:
第一通信单元,其包括:
支撑结构;
部分电源,其包括:
第一材料,其沉积到所述支撑结构上;以及
第二材料,其沉积到所述支撑结构上且与所述第一材料电隔离,其中所述第一材料和所述第二材料被选择为在与导电流体接触时具有电势差,以提供用以激活所述装置的电力;
控制模块,其与所述支撑结构相关联,且电连接到所述第一材料和所述第二材料,且被配置为控制所述第一材料与所述第二材料之间的电导,其中,当所述第一材料和所述第二材料与所述导电流体接触时,所述第一材料与所述第二材料之间的在电导上的变化改变电流签名,以由此在所述电流签名中编码信息;
第二通信单元,其与所述控制模块通信且与所述支撑结构相关联,以至少从外部源接收信号或将信号发送到外部源;以及
限定空腔的密封壳体,其中所述第一通信单元和所述第二通信单元安置在所述空腔内,且还包括在所述空腔内的电活性基体,其中所述第二通信单元产生电压以促使所述电活性基体膨胀且打开所述密封壳体,以将所述第一通信单元释放到所述导电流体中以激活所述部分电源且由此激活所述装置。
9.一种用于通信的装置,所述装置包括:
第一通信单元,其包括:
支撑结构;
部分电源,其包括:
第一材料,其沉积到所述支撑结构上;以及
第二材料,其沉积到所述支撑结构上且与所述第一材料电隔离,其中所述第一材料和所述第二材料被选择为在与导电流体接触时具有电势差,以提供用以激活所述装置的电力;
控制模块,其与所述支撑结构相关联,且电连接到所述第一材料和所述第二材料,且被配置为控制所述第一材料与所述第二材料之间的电导,其中,当所述第一材料和所述第二材料与所述导电流体接触时,所述第一材料与所述第二材料之间的在电导上的变化改变电流签名,以由此在所述电流签名中编码信息;以及
第二通信单元,其包括阻抗测量设备,所述阻抗测量设备被配置为测量包围所述装置的环境的阻抗,所述第二通信单元与所述控制模块通信且与所述支撑结构相关联,以至少从外部源接收信号或将信号发送到外部源,其中,在所述装置接触所述导电流体之后,所述第二通信单元响应于测量的阻抗而发送控制信号至所述控制模块,以调整所述电导从而将所述装置去激活或将所述装置延迟激活。
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EP2731497A2 (en) 2014-05-21
EP2731497B1 (en) 2016-04-27
RU2014104519A (ru) 2015-08-20
AU2017202754B2 (en) 2019-01-24
CN103781411A (zh) 2014-05-07
JP2014522695A (ja) 2014-09-08
EP2731497A4 (en) 2015-04-01
BR112014000624A2 (pt) 2017-02-14
AU2012282776A1 (en) 2014-01-30
WO2013009781A3 (en) 2013-04-04
KR20140066996A (ko) 2014-06-03
AU2017202754A1 (en) 2017-05-18
US20120007734A1 (en) 2012-01-12
TW201320962A (zh) 2013-06-01
CA2841904A1 (en) 2013-01-17
MX337132B (es) 2016-02-12
HK1196239A1 (zh) 2014-12-12
AU2012282776B2 (en) 2017-02-02
US20150173646A1 (en) 2015-06-25
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US8912908B2 (en) 2014-12-16
US9439582B2 (en) 2016-09-13

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