CN102112046B - 近距离通信装置和方法 - Google Patents

近距离通信装置和方法 Download PDF

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CN102112046B
CN102112046B CN200980129741.7A CN200980129741A CN102112046B CN 102112046 B CN102112046 B CN 102112046B CN 200980129741 A CN200980129741 A CN 200980129741A CN 102112046 B CN102112046 B CN 102112046B
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杰弗里·西库雷洛
马克·K·斯隆
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Abbott Diabetes Care Inc
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    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04LTRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L1/00Arrangements for detecting or preventing errors in the information received
    • H04L1/004Arrangements for detecting or preventing errors in the information received by using forward error control
    • H04L1/0045Arrangements at the receiver end
    • H04L1/0046Code rate detection or code type detection
    • 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
    • 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
    • A61B5/14532Measuring 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
    • 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
    • A61B5/14546Measuring 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
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04LTRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L1/00Arrangements for detecting or preventing errors in the information received
    • H04L1/004Arrangements for detecting or preventing errors in the information received by using forward error control
    • H04L1/0056Systems characterized by the type of code used
    • H04L1/0061Error detection codes
    • 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
    • A61B2560/0209Operational features of power management adapted for power saving
    • 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
    • A61B5/7232Signal processing specially adapted for physiological signals or for diagnostic purposes involving compression of the physiological signal, e.g. to extend the signal recording period
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06KGRAPHICAL DATA READING; PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
    • G06K7/00Methods or arrangements for sensing record carriers, e.g. for reading patterns
    • G06K7/10Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation
    • G06K7/10009Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves
    • G06K7/10366Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves the interrogation device being adapted for miscellaneous applications
    • G06K7/10376Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves the interrogation device being adapted for miscellaneous applications the interrogation device being adapted for being moveable
    • G06K7/10405Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves the interrogation device being adapted for miscellaneous applications the interrogation device being adapted for being moveable the interrogation device including an arrangement for sensing environmental parameters, such as a temperature or acceleration sensor, e.g. used as an on/off trigger or as a warning means

Abstract

本发明公开了在医疗系统中提供近距离检测的方法和设备。

Description

近距离通信装置和方法
优先权
本申请要求于2008年5月30日提交的题为“Close ProximityCommunication Device and Methods”的美国申请第12/130,995号的优先权,将其公开内容以引用方式并入本文用于所有目的。
背景技术
包括连续和离散监视系统的分析物监视系统,例如葡萄糖监视系统通常包括小型、轻量化的电池供电和微处理器控制的系统,该系统被构造成使用静电计来检测与相应的所测量的葡萄糖水平成比例的信号。RF信号可以用来发射(发送)所收集的数据。一些分析物监视系统的一个方面包括经皮或皮下分析物传感器配置(构造),该传感器配置例如至少部分通过其分析物水平被监视的受试者的皮肤层(表层)定位。传感器可以使用由通过接触系统连接的受控电位(稳压器)模拟电路驱动的两个或三个电极(工作电极、参考电极和反电极)配置。
分析物传感器可以被构造成使得其一部分置于患者的皮肤下面以便接触患者的分析物,而分析物传感器的另一部分或区段可以与发射器单元(transmitter unit)通信。发射器单元可以被构造成通过无线通信链路,例如RF(射频)通信链路,将由传感器检测的分析物水平发射(发送)至接收器/监视器单元。除其它功能,接收器/监视器单元可对接收的分析物水平进行数据分析,从而生成关于监视的分析物水平的信息。
控制或命令(指令)数据在无线通信链路上的发射经常限制在相当短的持续时间内发生。进而,数据通信中的时间约束对可以在发射时间周期期间发射的数据类型和大小施加限制。
考虑到上述,期望一种用于最优化例如在医疗通信系统中的两个或更多个通信装置之间的RF通信链路的方法和设备。
发明内容
本发明提供了用于分析物监视,例如葡萄糖监视的装置和方法,和/或治疗管理系统,该系统包括例如药物输注装置。实施方式包括例如使用遥测系统诸如RF遥测将信息从第一位置发射(发送)到第二位置。这里系统包括连续分析物监视系统、离散分析物监视系统、以及治疗管理系统。
根据下面的实施方式的详细描述、所附的权利要求和附图,本发明公开内容的这些和其它目的、特征以及优点将完全变得更显而易见。
附图说明
图1示出了用于实施本发明公开内容的一个或更多个实施方式的数据监视和管理系统的框图;
图2是根据本发明公开内容的一个实施方式的图1所示的数据监视和管理系统的发射器单元的框图;
图3是根据本发明公开内容的一个实施方式的图1所示的数据监视和管理系统的接收器/监视器单元的框图;
图4是示出了根据本发明公开内容的一个实施方式的包括用于发射(发送)的滚动数据(rolling data)的数据包程序的流程图;
图5是示出了根据本发明公开内容的一个实施方式的包括滚动数据的接收数据包的数据处理的流程图;
图6是示出了根据本发明公开内容的一个实施方式的图1的数据监视和管理系统的传感器单元和发射器单元的框图;
图7是示出了根据本发明公开内容的一个实施方式的使用图1的数据监视和管理系统中近距离(近程,close proximity)命令的数据通信的流程图;
图8是示出了根据本发明公开内容的一个实施方式的图1的数据监视和管理系统中配对或同步化例程的流程图;
图9是示出了根据本发明公开内容的另一个实施方式的图1的数据监视和管理系统中配对或同步化例程的流程图;
图10是示出了根据本发明公开内容的一个实施方式的图1的数据监视和管理系统中电源确定(determination)的流程图;
图11是示出了根据本发明公开内容的一个实施方式的数据监视和管理系统中用于RF通信控制的近距离命令的流程图;
图12示出了用于本发明公开内容的一个或多个实施方式的控制器发送的近距离数据包的数据格式;
图13是本发明公开内容的一个或多个实施方式中发射器单元620的近距离检测逻辑电路(近距离检测逻辑)的框图表示;以及
图14是示出了本发明公开内容的一个或多个实施方式中近距离检测逻辑电路的流程图。
具体实施方式
如上面总结和下面进一步详细描述的,根据本发明公开内容的各种实施方式,提供了一种在用于近距离通信的发射范围内用于定位控制器单元,发射一个或更多预定义的近距离命令,以及响应于发射的一个或更多预定义的近距离命令接收响应包(响应数据包)的方法和系统。
图1示出了根据本发明公开内容的一个实施方式的数据监视和管理系统,例如分析物(如葡萄糖)监视系统100。为了方便,本发明进一步主要关于葡萄糖监视系统进行描述,并且这样的描述绝不旨在限制本发明的范围。应当理解,分析物监视系统可以被构造成监视各种分析物,如乳酸盐等。
可以监视的分析物包括,例如,乙酰胆碱、淀粉酶、胆红素、胆固醇、绒膜促性腺激素、肌酸激酶(例如,CK-MB)、肌酸、DNA、果糖胺、葡萄糖、谷氨酰胺、生长激素、激素类、酮类、乳酸盐、过氧化物、前列腺特异性抗原、凝血酶原、RNA、促甲状腺激素、以及肌钙蛋白。也可以监视药物的浓度,例如抗生素(例如,庆大霉素、万古霉素等)、洋地黄毒苷、地高辛、滥用的药物、茶碱以及丙酮苄羟香豆素(杀鼠灵)。可以通过单独系统例如单独的分析物传感器来监视多于一种的分析物。
分析物监视系统100包括传感器单元101、可连接至传感器单元101的发射器单元102、以及被构造成经由双向通信链路103与发射器单元102通信的主接收器单元104。主接收器单元104可进一步被构造成将数据发射至数据处理终端105,用于评价由主接收器单元104接收的数据。此外,在一个实施方式中的数据处理终端105可以被构造成经由通信链路直接从发射器单元102接收数据,该通信链路可以可选地被构造成用于双向通信。因此,发射器单元102和/或接收器单元104可以包括收发器。
并且,在图1中示出了可操作性连接至通信链路并被构造成接收从发射器单元102发射的数据的可选次(副)接收器单元106。此外,如图中所示,次接收器单元106被构造成与主接收器单元104以及数据处理终端105通信。实际上,次接收器单元106可以被构造成用于与主接收器单元104和数据处理终端105中的每一个或其中的一个双向无线通信。如在下面进一步详细讨论的,在本发明公开内容的一个实施方式中,与主接收器单元104相比,次接收器单元106可以被构造成包括有限数量的功能和特性。同样,例如,次接收器单元106可以基本上被构造在较小的紧凑外壳中或在器件例如腕表、寻呼机、移动电话、PDA中实施。可替换地,次接收器单元106可以构造成具有与主接收器单元104相同或基本相似的功能性。接收器单元可以被构造成与对接式支架(docking cradle)单元一起用于,例如以下或其它功能中的一个或更多个:在床旁放置,用于再充电,用于数据管理,用于夜间监视,和/或双向通信装置。
在一个方面中,传感器单元101可以包括每个均被构造成与发射器单元102通信的两个或更多个传感器。此外,虽然只有一个,但发射器单元102、通信链路103和数据处理终端105在图1所示的分析物监视系统100的实施方式中示出。然而,本领域技术人员将认识到分析物监视系统100可以包括一个或更多传感器、多发射器单元102、通信链路103和数据处理终端105。此外,在本发明公开内容的范围内,分析物监视系统100可以是连续监视系统,或半连续监视系统,或离散(不连续)监视系统。在多组件环境中,每个装置均被构造成通过系统中的其它装置中的每一个唯一地识别,使得容易解决在分析物监视系统100内各种组件之间的通信冲突。
在本发明公开内容的一个实施方式中,传感器单元101物理定位在监视分析物水平的用户身体中或身体上。传感器单元101可以被构造成对用户的分析物水平进行连续采样,并将采样的分析物水平转换成相应的数据信号,用于通过发射器单元102发射。在一些实施方式中,发射器单元102可物理连接至传感器单元101,使得两个装置均集成在单独的外壳中,并且定位在用户的身体上。发射器单元102可以执行数据处理,例如对每个均对应于用户的采样的分析物水平的数据信号和/或其它功能进行滤波和编码,并且无论如何发射器单元102经由通信链路103将分析物信息发射至主接收器单元104。
在一个实施方式中,分析物监视系统100被构造成从发射器单元102到主接收器单元104的单向RF通信路径。在这样的实施方式中,发射器单元102发射从传感器单元101接收的采样数据信号,而不从主接收器单元104确认已接收到发射的采样数据信号。例如,发射器单元102可以被构造成在完成起始通电程序后以固定速率(例如,以一分钟间隔)发射编码的采样数据信号。同样,主接收器单元104可以被构造成以预定的时间间隔检测这样的发射的编码的采样数据信号。可替换地,分析物监视系统100可以被构造成在发射器单元102与主接收器单元104之间双向RF(或以其它方式)通信。
另外,在一个方面中,主接收器单元104可以包括两个部件(截面,section)。第一部件是被构造成经由通信链路103与发射器单元102通信的模拟接口部件(截面,section)。在一个实施方式中,模拟接口部件可包括RF接收器和天线,用于接收并放大来自发射器单元102的数据信号,该数据信号其后用本地振荡器解调并通过带通滤波器滤波。主接收器单元104的第二部件(second section)是被构造成例如通过执行数据解码、检错和纠错、数据时钟生成和数据位恢复,处理从发射器单元102接收的数据信号的数据处理区段(section)。
在操作中,在完成通电程序后,主接收器单元104被构造成在发射器单元102的范围内基于例如从发射器单元102接收的检测数据信号的强度和/或预定的发射器识别信息,来检测发射器单元102的存在。在与相应的发射器单元102成功同步化后,主接收器单元104被构造成开始从发射器单元102接收对应于用户的检测的分析物水平的数据信号。更具体地,在一个实施方式中的主接收器单元104被构造成经由通信链路103与相应的同步化的发射器单元102一起执行同步化的时间跳跃,从而获得用户的检测的分析物水平。
再次参考图1,数据处理终端105可以包括个人计算机、便携式计算机例如膝上型电脑或手持器件(装置)(例如,个人数字助理(PDA)),等,其每一个均可以被构造成用于经由有线或无线连接与接收器数据通信。另外,数据处理终端105可以进一步连接至数据网络(未示出),用于存储、检索和更新对应于用户的检测的分析物水平的数据。
在本发明公开内容的范围内,数据处理终端105可以包括输注装置例如胰岛素输注泵(外部或可植入)等,该输注装置可以被构造成将胰岛素给予患者,并可以被构造成与接收器单元104通信,用于尤其是接收测量的分析物水平。可替换地,接收器单元104可以被构造成集成或以其它方式连接至输注装置,其中使得接收器单元104被构造成尤其是基于从发射器单元102接收的检测的分析物水平将胰岛素治疗给予患者,例如,用于给药和修改基础分布曲线(basal profiles),以及用于确定用于给予的适当的药丸。
另外,发射器单元102、主接收器单元104和数据处理终端105均可以被构造成用于双向无线通信,使得发射器单元102、主接收器单元104和数据处理终端105中的每一个均可以被构造成经由无线通信链路103相互通信(即,相互发射和接收数据)。更具体地,在一个实施方式中数据处理终端105可以被构造成直接从发射器单元102经由通信链路106接收数据,其中通信链路106如上面描述的可以被构造成用于双向通信。
在该实施方式中,可以包括胰岛素泵的数据处理终端105可以被构造成从发射器单元102接收分析物信号,并且因此并入接收器103的功能,包括数据处理,用于管理患者的胰岛素治疗和分析物监视。在一个实施方式中,通信链路103可以包括允许多个单元(例如,根据HIPPA需求)的安全、无线通信,同时避免潜在数据冲突和干扰的RF通信协议、红外通信协议、蓝牙使能通信协议、802.11x无线通信协议或等效无线通信协议中的一个或多个。
图2是根据本发明公开内容的一个实施方式的图1所示的数据监视和检测系统的发射器的框图。参照该图,在一个实施方式中的发射器单元102包括被构造成与传感器单元101(图1)通信的模拟接口201、用户输入202和温度检测部件203,其每一个均可操作性地连接至发射器处理器204,例如中央处理单元(CPU)。如从图2中可以看到的,提供了四个接触(触点),其中三个是电极-工作电极(W)210、防护接触(G)211、参考电极(R)212和反电极(对电极)(C)213,每个均可操作性地连接至发射器单元102的模拟接口201,用于连接至传感器单元101(图1)。在一个实施方式中,工作电极(W)210、防护接触(G)211、参考电极(R)212和反电极(C)213中的每一个均可使用被印刷或蚀刻或烧蚀(消融)的导电材料制成,例如可以印刷的碳,或可蚀刻或烧蚀或以其它方式处理从而提供一个或更多个电极的金属诸如金属箔(例如,金)等。在一些实施方式中可以提供更少或更多的电极和/或接触。
此外,图2中示出了发射器串行通信部件205和RF发射器206,其每一个也可操作性地连接至发射器处理器204。此外,例如电池的电源207也设置在发射器单元102中,从而为发射器单元102提供必需的功率(电力)。另外,如从该图中可以看到的,尤其提供时钟208,从而向发射器处理器204供应实时信息。
在一个实施方式中,建立从传感器单元101(图1)和/或制造和测试设备到发射器单元102的模拟接口201的单向输入路径,同时建立来自发射器单元102的RF发射器206输出的单向输出,用于发射到主接收器单元104。以这种方式,图2中的数据路径示出在从模拟接口201经由专用链路209到串行通信部件205,其后到处理器204,并然后到RF发射器206的前述单向输入与输出之间。同样,在一个实施方式中,经由上面描述的数据路径,发射器单元102被构造成经由通信链路103(图1)向主接收器单元104(图1)发射从传感器单元101(图1)接收的经处理和编码的数据信号。另外,在上面讨论的模拟接口201与RF发射器206之间的单向通信数据路径允许发射器单元102的配置,用于在制造工艺完成后操作,以及用于为诊断和测试目的直接通信。
如上面所讨论的,发射器处理器204被构造成在发射器单元102的操作期间将控制信号发射至发射器单元102的各种部件。在一个实施方式中,发射器处理器204还包括存储器(未示出),用于存储数据例如发射器单元102的识别信息,以及从传感器单元101接收的数据信号。存储的信息可以被检索和处理,用于在发射器处理器204的控制下发射(发送)至主接收器单元104。此外,电源207可以包括可以是可充电电池的商购电池。
在一些实施方式中,发射器单元102也被构造成使得电源部件(section)207能够向发射器供电,用于最短大约三个月的连续操作,例如,在诸如以低功率(非操作)模式存储大约十八个月之后。在一个实施方式中,这可通过以低功率模式在非操作状态下操作的发射器处理器204来实现,例如提取不多于接近1μA的电流。实际上,在一个实施方式中,在发射器单元102的制造工艺期间的步骤可将发射器单元102置于低功率、非操作状态中(即,后制造睡眠模式)。以这种方式,发射器单元102的贮存寿命可以被显著改善。此外,如图2中所示,尽管电源单元207示出为连接至处理器204,并且因此,处理器204被构造成提供电源单元207的控制,但应当注意在本发明公开内容的范围内,电源单元207被构造成向图2所示的发射器单元102的组件中的每一个提供必要的功率。
回来参考图2,在一个实施方式中的发射器单元102的电源部件207可以包括可通过分离的电源再充电单元(例如,设置在接收器单元104中)再充电的可再充电电池单元,使得可在较长的使用时间周期为发射器单元102供电。此外,在一个实施方式中,在电源部件207中没有电池的情况下,可以构造发射器单元102,其中发射器单元102可以被构造成从外部电源(例如,电池)接收电力,如下面进一步详细讨论的。
仍再次参考图2,发射器单元102的温度检测部件203被构造成监视靠近传感器插入位点的皮肤的温度。温度读数用来调节由模拟接口201获得的分析物读数。在一些实施方式中,发射器单元102的RF发射器206可以被构造成用于在大约315MHz至大约322MHz的频带中操作,例如,在美国。在一些实施例中,发射器单元102的RF发射器206可以被构造成用于在大约400MHz至大约470MHz的频带中操作。此外,在一个实施方式中,RF发射器206被构造成通过执行频移键控和曼彻斯特编码来调制载波频率。在一个实施方式中,在与主接收器单元104通信的最小发射范围的情况下,数据发射速率约为每秒19,200个符号。
仍再次参考图2,还示出了在数据监视和管理系统100的发射器单元102中连接至防护电极(G)211和处理器204的泄漏检测电路214。根据本发明公开内容的一个实施方式的泄漏检测电路214可以被构造成检测传感器单元101中的漏电流,从而确定测量的传感器数据是否讹误或来自传感器101的测量数据是否准确。可以采用的示例性分析物系统描述在例如美国专利号6,134,461、6,175,752、6,121,611、6,560,471、6,746,582以及其它专利中,将其每一个的公开内容以引用方式并入本文用于所有目的。
图3是根据本发明公开内容的一个实施方式的图1所示的数据监视和管理系统的接收器/监视器单元的框图。参考图3,主接收器单元104包括分析物测试条例如血糖测试条、接口301、RF接收器302、输入303、温度检测部件304和时钟305,其每一个均可操作性地连接至接收器处理器307。如从该图中进一步可以看到的,主接收器单元104也包括可操作性地连接至功率转换和监视部件308的电源306。此外,功率转换和监视部件308也连接至接收器处理器307。此外,还示出了每个均可操作性地连接至接收器处理器307的接收器串行通信部件309和输出310。
在一个实施方式中,测试条接口301包括葡萄糖水平测试部分,以接收葡萄糖测试条的手动插入,并从而确定和显示主接收器单元104的输出310上的测试条的葡萄糖水平。葡萄糖的该手动测试可以用来校准传感器单元101或其它。RF接收器302被构造成经由通信链路103(图1)与发射器单元102的RF发射器206通信,从而尤其是从发射器单元102接收编码的数据信号,用于信号混合、解调和其它数据处理。如果需要,主接收器单元104的输入303被构造成允许用户将信息输入到主接收器单元104中。在一个方面中,输入303可以包括小键盘的一个或更多个按键、触敏屏幕或语音激活的输入命令单元。温度检测部件304被构造成向接收器处理器307提供主接收器单元104的温度信息,而时钟305尤其是向接收器处理器307提供实时信息。
在一个实施方式中,图3所示的主接收器单元104的各种组件中的每一个都通过包括电池的电源306供电。此外,功率转换和监视部件308被构造成通过主接收器单元104中的各种组件监视功率使用,用于有效的功率管理并且例如功率使用如果使主接收器单元104处于次最优操作条件,则警告用户。这样的次最优操作条件的实例可以包括例如操作振动输出模式(如下面讨论的)一段时间周期,因此在处理器307(因此主接收器单元104)开启时基本上损耗(draining)电源306。此外,功率转换和监视部件308可以另外被构造成包括反极性保护电路,例如构造成电池激活开关的场效应晶体管(FET)。
主接收器单元104中的串行通信部件309被构造成尤其提供来自测试和/或制造设备的双向通信路径,用于主接收器单元104的初始化、测试和配置(构造)。串行通信部件104也可以用来将数据上载到计算机,例如时标血糖数据。可通过例如线缆、红外(IR)或RF链路来制造与外部装置(未示出)通信的通信链路。主接收器单元104的输出310被构造成尤其提供用于显示信息的图形用户界面(GUI)例如液晶显示器(LCD)。另外,输出310也可以包括用于输出可听信号的集成的扬声器,以及提供如通常在手持式电子器件,例如当前可用的移动电话中发现的振动输出。在另外的实施方式中,主接收器单元104还包括被构造成向输出310提供背光的电致发光灯,用于在黑暗的周围环境中输出视觉显示。
回来参考图3,一个实施方式中的主接收器单元104还可以包括作为处理器307的部分,或独立设置在主接收器单元104中的可操作性连接至处理器307的存储部件,诸如可编程、非易失性存储器件。处理器307可以被构造成与发射器同步化,例如,在从发射器单元102经由通信链路103接收编码的数据信号后,使用曼彻斯特解码等以及检错与纠错。
可在主题发明的实施方式中采用的在发射器单元102与主接收器单元104之间的RF通信(或与次发射器106的通信)的另外描述披露在于2005年2月16日提交的题为“Method and System for Providing DataCommunication in Continuous Glucose Monitoring and Management System”的待决申请号11/060,365中,将其公开内容以引用方式并入本文用于所有目的。
参考该图,在一个实施方式中,发射器102(图1)可以被构造成生成数据包用于周期性发射至接收器单元104、106中的一个或更多个,其中每个数据包在一个实施方式中均包括两个数据种类-紧急数据和非紧急数据。例如,来自传感器和/或与传感器有关的温度数据的紧急数据,例如如葡萄糖数据可以包装(压缩)在除非紧急数据之外的每个数据包中,其中非紧急数据用每个数据包发射来滚动或改变。
即,非紧急数据以定时时间间隔发射,使得维持分析物监视系统的完整性而不经由RF通信链路与来自发射器102的每个数据发射包一起发射。以这种方式,非紧急数据,例如非时敏数据,可周期性发射(并且不与每个数据包一起发射)或分解到预定数量的部件中,并经由多信息包发送或发射,而紧急数据基本上全部与每个数据发射一起发射。
再次参考该图,在从发射器102接收数据包后,一个或更多个接收器单元104、106可以被构造成解析接收的数据包,从而使紧急数据与非紧急数据分离,并且,也可以被构造成以例如分级方式存储紧急数据和非紧急数据。根据数据包或数据发射协议的特定配置,或多或少的数据可以作为紧急数据或非紧急滚动数据的部分发射。即,在本发明公开内容的范围内,具体数据包实现如每个包的位数量等,可以尤其是基于通信协议、数据发射时间窗口等变化。
在示例性的实施方式中,由此可以识别不同类型的数据包。例如,在一些示例性实施方式中,识别可以包括(1)单传感器,数据的一分钟,(2)两个或多个传感器,(3)双传感器(dual sensor),交替一分钟数据,以及(4)响应包。在一个实施方式中,对于单传感器一分钟数据包,发射器204可以被构造成以在下面表1中示出的方式或类似方式生成数据包。
表1.单传感器,一分钟数据
  位数量   数据子段(数据区)
  8   发射时间
  14   传感器1当前数据
  14   传感器1历史数据
  8   发射状态
  12   AUX计数器
  12   AUX热敏电阻器(热敏电阻,Thermistor)1
  12   AUX热敏电阻器2
  8   滚动-数据-1
如上面表1中示出的,一个实施方式中的发射器数据包可以包括8位的发射时间数据、14位的当前传感器数据、14位的先前传感器数据、8位的发射器状态数据、12位的辅助计数器数据、12位的辅助热敏电阻器1数据、12位的辅助热敏电阻器2数据和8位的滚动数据。在本发明公开内容的一个实施方式中,通过发射器生成以用于经由RF通信链路发射的数据包可以包括上面表1中示出的数据的全部或一些。
回来参考,14位的当前传感器数据提供了与检测的分析物水平相关的实时或当前传感器数据,而14位的传感器历史或先前传感器数据包括与一分钟前检测的分析物水平相关的传感器数据。以这种方式,在其中接收器104、106放弃(drops)或不能在逐分钟发射中从发射器102成功接收数据包的情况下,接收器单元104、106能够从后来的分钟发射捕获先前的分钟发射的传感器数据。
再次参考表1,一个实施方式中的辅助数据可以包括患者的皮肤温度数据、温度梯度数据、参考数据和反电极电压中的一个或更多个。发射器状态字段(区,field)可以包括被构造成指示不可靠数据(错误数据)的状态数据用于当前发射(例如,如果示出为BAD状态(与表示在当前发射中的数据没有讹误的GOOD状态相反))。此外,滚动数据字段被构造成包括非紧急数据,并且在一个实施方式中,可能与跳时(time-hop)序列数有关。另外,在一个实施方式中的发射器时间字段包括被构造成以零开始,并且每个数据包增加一的协议值。在一个方面中,发射器时间数据可以用来使数据发射窗口与接收器单元104、106同步,并且也为滚动数据字段提供索引。
在另外的实施方式中,发射器数据包可以被构造成提供或发射来自两个或更多独立的分析物传感器的分析物传感器数据。该传感器可涉及相同或不同的分析物或性质。在这样的情况下,在其中采用2个传感器的实施方式中,来自发射器102的数据包可以被构造成包括来自两个传感器的14位的当前传感器数据。在这种情况下,数据包在当前数据包发射中并不包括直接在前的传感器数据。相反,第二分析物传感器数据与第一分析物传感器数据一起发射。
表2.双传感器数据
  位数量  数据字段
  8  发射时间
  14  传感器1当前数据
  14  传感器2当前数据
  8  发射状态
  12  AUX计数器
  12  AUX热敏电阻器1
  12  AUX热敏电阻器2
  8  滚动-数据-1
在另外的实施方式中,发射器数据包可以与两个分析物传感器之间的每个发射交替,例如,在下面的表3和表4中示出的数据包之间交替。
表3.传感器数据包交替1
  位数量  数据字段
  8  发射时间
  14  传感器1当前数据
  14  传感器1历史数据
  8  发射状态
  12  AUX计数器
  12  AUX热敏电阻器1
  12  AUX热敏电阻器2
  8  滚动-数据-1
表4.传感器数据包交替2
  位数量  数据字段
  8  发射时间
  14  传感器1当前数据
  14  传感器2当前数据
  8  发射状态
  12  AUX计数器
  12  AUX热敏电阻器1
  12  AUX热敏电阻器2
  8  滚动-数据-1
如上面参考表3和表4示出的,在一个实施方式中的来自发射器102(图1)的逐分钟数据包发射可以在表3所示的数据包与表4所示的数据包之间交替。更具体地,在一个实施方式中发射器102可以被构造成发射第一传感器的当前传感器数据和第一传感器的先前传感器数据(表3)以及滚动数据,并且进一步地,在随后的发射中,发射器102可以被构造成发射除滚动数据之外的第一和第二传感器的当前传感器数据。
在一个实施方式中,与每个数据包一起发射的滚动数据可以包括认为是非紧急和非时敏的各种预定类型数据的序列。即,在一个实施方式中,表5所示的下面数据列表可以顺序包括在8位的发射器数据包中,并且不与发射器的每个数据包发射一起发射(例如,与来自发射器102的每个60秒数据发射一起发射)。
表5.滚动数据
  时隙(时间槽)   位   滚动数据
  0   8   模式
  1   8   葡萄糖1斜率
  2   8   葡萄糖2斜率
  3   8   Ref-R
  4   8   Hobbs计数器,Ref-R
  5   8   Hobbs计数器
  6   8   Hobbs计数器
  7   8   传感器计数
如从上面表5中可以看到的,在一个实施方式中,滚动数据的序列附加或添加到具有每个数据发射时间槽的发射器数据包上。在一个实施方式中,可以具有256个时隙,用于通过发射器102(图1)的数据发射,并且其中,每个时隙都以大约60秒的间隔分开。例如,参考上面的表5,在发射时隙0(零)中的数据包可以包括作为附加到发射的数据包的滚动数据的操作模式数据(模式)。在随后的数据发射时隙(例如,在起始时隙(0)大约60秒之后,发射的数据包可以包括作为滚动数据的分析物传感器1校准因数信息(葡萄糖1斜率))。以这种方式,通过每个数据发射,滚动数据可经由256个时隙循环更新。
再次参考表5,针对不同实施方式进一步详细地描述了每个滚动数据字段。例如,模式数据可以包括与不同操作模式有关的信息,例如但不限于数据包类型、使用的电池的类型、诊断例程、单传感器或多传感器输入、或数据发射类型(RF通信链路或其它数据链路,例如串行连接)。此外,葡萄糖1-斜率数据可以包括第一传感器的8-位比例因数或校准数据(传感器1数据的比例因数),而葡萄糖2-斜率数据可以包括第二分析物传感器的8-位比例因数或校准数据(在该实施方式中包括多于一个的分析物传感器)。
另外,Ref-R数据可以在热敏电阻器电路中包括用来校准我们的温度测量的12位的机载参考电阻器(其中8位在时隙3中发射,并且剩余的4位在时隙4中发射),并且20-位Hobbs计数器数据可在三个时隙中分离发射。(例如,在时隙4、时隙5和时隙6中),从而总计为20位。在一个实施方式中,Hobbs计数器可以被构造成对数据发射的每次发生进行计数(例如,大约60秒间隔的包发射)并且可以以(1)的计数增加。
在一个方面中,Hobbs计数器存储在发射器单元102(图1)的非易失性存储器中,并且可以用来确定电源状态信息,例如在发射器单元102中剩余的估计电池寿命。即,在每个传感器更换的情况下,Hobbs计数器不复位,但继续以传感器单元101的每个更换计数,从而建立与发射器单元102的接触,使得经由发射器单元102的延长的使用时间,可能可以基于Hobbs计数信息确定在发射器单元102中的消耗的电池寿命量,并且还确定在发射器单元102中电池的估计的剩余寿命。
即,在一个实施方式中,每当发射器单元102发射数据包(例如,大约每60秒),20位Hobbs计数器加一,并基于在Hobbs计数器中的计数信息,在一个方面中,可以估计发射器单元102的电池寿命。以这种方式,在发射器单元620(参见图6)的配置中,其中电源不是可更换组件但嵌入在发射器单元620的外壳内,可以估计发射器单元620内的嵌入电池的剩余寿命。此外,Hobbs计数器被构造成在发射器单元620的存储器件中保持不变,使得即使在发射器单元电力关闭或断电(例如,在周期传感器单元更换、RF发射关闭周期等期间)时,保留Hobbs计数器信息。
参考上面的表5,发射的滚动数据也可以包括8位的传感器计数信息(例如,在时隙7中发射的)。每当新传感器单元连接至发射器单元时,8位传感器计数器加一。发射器单元的专用集成电路(ASIC)配置(或基于发射器配置或具有离散组件的微处理器)可以被构造成在非易失性存储器单元中存储传感器计数信息,并将它发射至主接收器单元104(例如)。进而,主接收器单元104(和/或次接收器单元106)可以被构造成确定是否从与相同传感器单元相关的发射器单元接收数据(基于传感器计数信息),或从新的或更换的传感器单元接收数据(其使来自先前传感器计数的传感器计数加一)。以这种方式,在一个方面中,接收器单元(主要或次要(副))可以被构造成由用户基于检验与从发射器单元102接收的数据发射相关的传感器计数信息,防止相同传感器单元的再使用。此外,在另外的方面中,用户提示可以与这些参数中的一个或更多个相关。此外,接收器单元(主要或次要)可以被构造成检测何时插入新传感器,并因此防止连同先前传感器确定的一个或更多个校准参数的错误应用,这可潜在地导致基于传感器数据的错误或不精确的分析物水平确定。
图4是示出了根据本发明公开内容的一个实施方式的包括用于发射的滚动数据的数据包程序的流程图。参考图4,在一个实施方式中,初始化计数器(例如,初始化为T=0)(410)。其后,例如从存储器件检索相关的滚动数据(420),并且还检索时敏或紧急数据(430)。在一个实施方式中,可基本上同时检索滚动数据(420)的检索和时敏数据(430)的检索。
回来参考图4,通过滚动数据和时敏数据,例如,生成用于发射的数据包(440),并且在发射后,计数器加一(450),并且例程返回到滚动数据(420)的检索。以这种方式,在一个实施方式中,紧急时敏数据以及非紧急数据都可并入相同的数据包中,并且通过发射器102(图1)发射至远程设备,例如接收器104、106中的一个或更多个。此外,如上面讨论的,滚动数据可在长于来自发射器102(图1)的每个数据包发射的时间间隔的预定时间间隔更新。
图5是示出了根据本发明的公开内容的一个实施方式的包括滚动数据的接收数据包的数据处理的流程图。参考图5,当接收该数据包时(510)(例如,在一个实施方式中,通过接收器104、106中的一个或更多个),解析接收的数据包,使得紧急数据可与非紧急数据分离(例如,存储在数据包中的滚动数据字段中)(520)。其后解析的数据适当地存储在合适的存储器或存储设备中(530)。
以上面描述的方式,根据本发明公开内容的一个实施方式,提供了方法和设备用于从待经由通信链路发射的紧急类型数据(例如,监视的分析物相关数据)分离非紧急类型数据(例如,与校准相关的数据),从而使可用发射时间上的潜在负担或约束最小化。更具体地,在一个实施方式中,非紧急数据可以从通信系统需要的待立即发射的数据分离,并经由通信链路一起发射,同时维持最小发射时间窗口。在一个实施方式中,非紧急数据可解析或分解为许多数据段,并经由多个数据包发射。时敏立即数据(例如,分析物传感器数据、温度数据等)可经由通信链路基本上全部与每个数据包或发射一起发射。
图6是示出了根据本发明公开内容的一个实施方式的图1的数据监视和管理系统的传感器单元和发射器单元的框图。参考图6,在一个方面中,发射器单元620设置在基本上防水和密封的外壳中。发射器单元620包括各接触(wrk、ref、cntr和grd)用于分别建立与传感器单元610的工作电极、参考电极、反电极和接地端子(或防护线(guard trace))中的一个或更多的电接触。在图6中也示出了设置在传感器单元610上的导电杆(导电条,conductivity bar)/线611。例如,在一个实施方式中,导电杆/线611可在传感器单元610的衬底层上包括碳线(carbon trace)。以这种方式,在一个实施方式中,例如,当传感器单元610连接至发射器单元620时,经由在发射器单元620的接触衬垫或点之间的导电杆/线611建立电接触(例如,在反电极接触(cntr)和接地端子接触(grd)上),使得发射器单元620可被供电用于数据通信。
即,在发射器单元620的制造期间,在一个方面中,发射器单元620被构造成包括电源,例如电池621。此外,在初始非使用周期期间(例如,后制造睡眠模式),发射器单元620被构造成使得不使用其并因此通过发射器单元620的组件排尽。在睡眠模式期间,并在经由导电杆/线611建立与传感器单元610的电接触之前,发射器单元620设置有例如经电子开关623来自低功率电压比较器622的低功率信号,从而维持例如发射器单元620组件的低功率状态。此后,在与传感器单元610连接后,并且经由导电杆/线611建立电接触,发射器单元620的嵌入电源621被激活或加电,使得发射器单元620的所有组件中的一些被构造成接收必要的功率信号,用于与例如数据通信、处理和/或存储有关的操作。
在一个方面中,由于发射器单元620被构造至密封外壳而没有分离的可更换电池隔室,因此以这种方式,在使用之前的后制造睡眠模式期间保护电池621的电源。
在另外的方面中,发射器单元620可以设置或定位在分离的体上(on-body)安装单元上,该安装单元可以包括例如粘合层(在其底部表面上),从而将安装单元稳固地保持在用户的皮肤上,并且其被构造成在使用期间接收发射器单元620或将其稳固地定位在安装单元上。在一个方面中,安装单元可以被构造成以经皮方式至少部分地保持传感器单元610的位置,使得传感器单元的至少一部分与用户的分析物流体接触。该安装单元或基础单元以及其与发射器单元的协作或结合的示例性实施方式在例如美国专利第6,175,752号中提供,将其以引用方式并入本文用于所有目的。
在这样的配置中,用于发射器单元620的电源可以设置在安装单元的外壳内,使得发射器单元620可以被构造成在发射器单元620放置在安装单元上并与传感器单元610电接触后被通电或激活。例如,传感器单元610可以设置成与安装单元和插入器件一起预配置或集成,使得用户可以使用连接至安装单元的插入器件将传感器单元610定位在用户的皮肤层上。此后,在传感器单元610的经皮定位后,插入器件可从安装单元丢弃或移除,在用户的皮肤表面上留下经皮定位的传感器单元610和安装单元。
此后,当发射器单元620定位在安装单元上或安装单元内时,设置在安装单元内的电池或电源被构造成电连接至发射器单元620和/或传感器单元610。假定传感器单元610和安装单元作为用于每3、5、7天或其它预定时间周期更换的可更换组件提供,则在使用期间用户方便不负担检验向发射器单元620提供电力的电源的状态。即,通过用传感器单元610的每一更换来替换电源或电池,新的电源或电池将设置有新的安装单元,用于与发射器单元620一起使用。
再次参考图6,在一个方面中,当传感器单元610从发射器单元620移除(或反之亦然)时,电接触破坏,并且导电杆/线611返回到开路。在这种情况下,发射器单元620可以被构造成检测这样的条件,并生成发送至主接收器单元104(和/或次发射器单元106)的最后的系统性能总分析发射(gasp transmittion),表明传感器单元610从发射器单元620断开,并且发射器单元620进入断电(或低功率关闭)状态。并且,由于到电源(嵌入在发射器单元620外壳内)的连接破坏,因此发射器单元620断电进入睡眠模式。
以这种方式,在一个方面中,发射器单元620的处理器624可以被构造成生成与检测传感器单元610断开相关的适当的一个或更多数据或信号,用于发射到接收器单元104(图1),并且,还启动发射器单元620的断电程序。在一个方面中,发射器单元620的组件可以被构造成包括具有一个或更多状态机和一个或更多非易失性和/或易失性存储器单元,例如如EEPROM等的专用集成电路(ASIC)设计。
再次参考图1和图6,在一个实施方式中,发射器单元620(或图1的102)与主接收器单元104(和/或次发射器单元106)之间的通信可基于近距离通信,其中双向(或单向)无线通信在装置物理相互处于近距离时建立。即,在一个实施方式中,发射器单元620可以被构造成从主接收器单元104(图1)接收非常短范围的命令,并基于来自接收器单元104的接收命令执行一个或更多具体操作。
在一个实施方式中,为了维持发射器单元与数据接收器单元之间的安全通信,发射器单元ASIC可被构造成在供电或初始化时生成唯一的近距离密钥。在一个方面中,4或8位密钥可以基于例如发射器单元识别信息生成,并且其可以用来防止不期望的或不想要的通信。在另外的方面中,在发射器单元和接收器单元的初始同步化或配对程序期间,近距离密钥可以通过接收器单元基于例如由发射器单元接收的发射器识别信息而生成。
再次参考图1和图6,在一个实施方式中,发射器单元ASIC配置可以包括可以被构造成驱动发射器单元ASIC中的状态机的32KHz振荡器和计数器。发射器ASIC配置可以包括多个近距离通信命令,该命令尤其包括例如新传感器启动、与接收器单元配对,以及RF通信控制。例如,当新传感器单元定位和连接至发射器单元,使得该发射器单元通电时,该发射器单元被构造成检测或接收来自接近发射器单元定位的接收器单元的命令。例如,接收器单元可以定位在离发射器单元的体上位置两英寸内,并且当用户激活或启动来自接收器单元的与新传感器启动相关的命令时,发射器单元被构造成从该接收器接收命令,并且尤其在其响应数据包中将其识别信息发射回接收器单元。
在一个实施方式中,初始传感器单元启动命令并不需要使用近距离密钥。然而,其它预定义或预配置的近距离命令可以被构造成需要使用8位密钥(或不同数量的位的密钥)。例如,在一个实施方式中,接收器单元可以被构造成发射RF开/关命令,从而打开/关闭发射器单元102中的RF通信模块或单元。一个实施方式中的这样的RF开/关命令包括作为发射的命令一部分的近距离密钥,用于通过发射器单元接收。
在RF通信模块或单元基于接收的近距离命令关闭的周期期间,发射器单元并不发射任何数据,包括任何葡萄糖相关数据。在一个实施方式中,在发射器单元的RF通信模块或单元关闭时的时间周期期间,不通过发射器单元发射的来自传感器单元的葡萄糖相关数据可存储在发射器单元的存储器或存储单元中,用于随后在发射器单元RF通信模块或单元基于来自接收器单元的RF-开启命令返回开启时发射到接收器单元。以这种方式,在一个实施方式中,发射器单元可断电(临时,例如,在空中旅行期间)而不从身体上的位置移除发射器单元。
图7是示出了根据本发明公开内容的一个实施方式的使用图1的数据监视和管理系统中近距离命令的数据通信的流程图。参考图7,在一方面中主接收器单元104(图1)可以被构造成检索或生成用于发射到发射器单元102的近距离命令(710)。为了建立发射范围(720),主接收器单元104可物理上接近发射器单元102定位(即,在来自发射器单元102的预定距离内)。例如,用于近距离通信的发射范围可在发射器单元102与主接收器单元104之间在大约一英尺的距离或更小建立。当发射器单元102和主接收器单元104处于该发射范围内时,近距离命令在由主接收器单元104启动后可发射至发射器单元102(730)。
回来参考图7,响应于发射的近距离命令,可以接收响应数据包或其它响应通信(740)。在一个方面中,响应数据包或其它响应通信可以包括将响应数据包或其它响应通信发射到接收器单元104的发射器单元102的识别信息。在一个方面中,接收器单元104可以被构造成基于该发射器识别信息生成密钥(例如,8位密钥或预定长度的密钥)(750),并且该密钥可在随后的发射器单元102与接收器单元104之间近距离通信中使用。
在一个方面中,包括生成的密钥的数据通信可允许数据通信的接收者(接受者)识别数据通信的发送者,并确认数据通信的发送者是预期的数据发送装置,并且因此,包括数据通信的接收者期望或预期的数据。以这种方式,在一个实施方式中,一个或更多近距离命令可以被构造成包括作为发射的数据包的部分的生成的密钥。此外,生成的密钥可基于发射器ID或其它合适的唯一信息,使得接收器单元104可以使用这样的信息,用于生成用于在装置之间双向通信的唯一密钥的目的。
虽然上面的描述包括基于发射器单元102的识别信息生成密钥,但在本发明公开内容的范围内,密钥可基于与发射器单元102和/或接收器单元组合相关的一个或更多其它信息而生成。在另外的实施方式中,密钥可译成秘密并存储在发射器单元102中的存储器单元或存储器件中,用于发射到接收器单元104。
图8是示出了根据本发明公开内容的一个实施方式的图1的数据监视和管理系统中配对或同步化例程的流程图。参考图8,在一个实施方式中,发射器单元102可以被构造成从定位在近距离发射范围内的接收器单元104接收传感器启动近距离命令(810)。基于接收的传感器启动命令,可以检索发射器单元识别信息(例如,来自非易失性存储器),并发射到接收器单元104或传感器启动命令的发送者(820)。
回来参考图8,在一个实施方式中接收可选译码的通信密钥(830),并且此后,传感器相关数据与通信密钥一起在周期基础(periodic basis)上,例如每60秒、五分钟或任何合适的预定时间间隔发射(840)。
现在参考图9,示出了根据本发明公开内容的另一实施方式的图1的数据监视和管理系统中配对或同步化例程的流程图。即,在一个方面中,图9示出了来自接收器单元104的配对或同步化例程。回来参考图9,当接收器单元104定位在近发射范围内时,传感器启动命令发射到发射器单元102(910)。此后,在一个方面中,例如从接收传感器启动命令的发射器单元接收发射器识别信息(920)。此后,可生成通信密钥(可选译码的)并发射到(930)发射器单元。
以上面描述的方式,在一个实施方式中,在发射器单元102与接收器单元104之间的简化的配对或同步化可使用例如装置之间的近距离命令建立。如上面描述的,在一个方面中,在配对或同步化后,发射器单元102可以被构造成将分析物水平信息周期性地发射至接收器单元用于进一步处理。
图10是示出了根据本发明公开内容的一个实施方式的图1的数据监视和管理系统中电源确定的流程图。即,在一个实施方式中,使用计数器,接收器单元104可以被构造成确定发射器单元102电池的供电水平,以便确定用于更换电源或发射器单元102自身的合适时间。参考图10,检测周期性数据发射(1010),并且计数器中的相应计数例如随着每个检测的数据发射增加一(1020)。特别地,Hobbs计数器可用于上面描述的滚动数据配置,从而提供作为与发射器单元数据发射发生相关的计数。
参考图10,存储在Hobbs计数器中的更新或增加的计数在数据包中从发射器单元102周期性地发射至接收器单元104(1030)。此外,增加的或更新的计数可存储在发射器单元102的永久非易失性存储器单元中(1040)。因此,基于数据发射发生的数量,可估计电池供电水平,并且又可以提供关于电池(并因此在电源被制造成嵌入在发射器单元外壳内的该实施方式中的发射器单元)需要更换时的指示。
此外,在一个方面中,Hobbs计数器中的增加的计数存储在永久非易失性存储器中,使得计数器不在每个传感器单元更换的情况下复位或以其它方式重新启动。
图11是示出了根据本发明公开内容的一个实施方式的图1的数据监视和管理系统中RF通信控制的近距离命令的流程图。参考图11,例如接收与通信状态相关的近距离命令(1110)。在一个方面中,与通信状态相关的命令可以包括例如用于例如开启或关闭发射器单元102的相关RF通信装置的通信模块开启或关闭命令。参考图11,确定通信状态(1120),并且此后基于接收的命令修改通信状态(1130)。
即,在一个方面中,使用一个或更多近距离命令,例如接收器单元104可以被构造成控制发射器单元102的RF通信,从而使RF通信功能在预定时间周期失能(无效)或关闭。当用于其中RF通信装置需要失能(失效)的空中旅行或其它位置例如医院环境(医院设置,hospital settings)时这可能特别有用。在一个方面中,近距离命令可用于开启或关闭发射器单元102的RF通信模块,使得当接收器单元104接近发射器单元102定位,并且发射RF命令时,在一个实施方式中,发射器单元102被构造成关闭或开启发射器单元102的RF通信能力。
图12示出了通过控制器例如接收器单元104/106发送到分析物监视系统100(图1)中的发射器单元620(图6)的近距离数据包的数据格式。参考图12,在一个实施方式中,控制器发送的近距离数据包可包括24位的数据。在一个方面中,该24位数据包可以包括打点模式(点模式,dottingpattern)1210、数据帧1220、一个或更多近距离命令1230和近距离密钥1240。如在下面进一步详细讨论的,在一个实施方式中,发射器单元620ASIC逻辑中的序列检测器1330(图13)使用打点模式1210和数据帧1220,从而确定输入数据是否为合适的近距离数据包。在一个方面中,如图12所示的近距离数据包可以包括可由近距离检测器逻辑使用从而检测和同步化接收的数据的打点模式1210、包括在实际接收的数据之前的位模式的数据帧1220、近距离命令1230和近距离密钥1240,从而验证近距离通信。
在一个方面中,可存在五个有效的近距离命令1230,并且近距离密钥1240可以用作例如从控制器(接收器单元104/106)接收的通信的验证。虽然上面描述了用于近距离命令的24位数据包和五个有效的近距离命令1230,但在本发明公开内容的范围内,用于近距离命令的数据包可以在该数据包内包括更多或更少数量的位,并且进一步地,有效近距离命令的数量可以多于或少于如上面描述的五个有效近距离命令。
图13是本发明公开内容的一个或更多实施方式中发射器单元620的近距离检测逻辑的框图表示。参考图13,在一个实施方式中,例如来自控制器(接收器单元104/106)的输入的曼彻斯特编码数据包以大于4.8千位/秒的速率通过近距离检测器逻辑接收,并通过曼彻斯特位解码器逻辑1310解码。曼彻斯特位解码器逻辑1310检测两个数据符号,并可以被构造成将检测的数据以2.4千位/秒转化为一个数据位。
在一个方面中,解码的数据位发送至位定时计数器逻辑1320、序列检测器逻辑1330和移位寄存器逻辑1340。在一个实施方式中,序列检测器逻辑1330寻找示出接收的数据包的可靠性的预定数据模式(datapattern)。在一个方面中,预定数据模式,例如“0100”,包括打点模式“01”和数据帧“00”的发生。如果仅检测到部分序列,接着为不正确的数据位,则序列检测器逻辑1330可以被构造成复位并等待下个数据包。另一方面,如果正确的数据包与期望或预期的预定数据模式一起接收,例如“0100”,则序列检测器逻辑1330认为数据包有效。
当确定数据包具有正确的打点模式和数据帧,并认为有效时,复位信号(重设信号)失能并且移位寄存器信号使能。通过使能的移位寄存器信号,验证的数据的每个输入位锁存到11位包络检波器移位寄存器逻辑1340中。一旦第11位锁存到寄存器1340中,则开/关键控(OOK)信号表明近距离通信已经完成。一旦近距离命令被发送和解码,则包络检波有限状态机(FSM)逻辑1360被构造成处理该命令。在处理期间,不接受另外的命令,并且近距离状态机逻辑1360锁定在最终状态中。一旦该命令已经被处理,则近距离逻辑通过逻辑复位信号复位。然后该近距离逻辑返回到其初始状态,并等待另外的命令。
再次参考图13,近距离密钥1350可连同近距离命令数据包一起使用,从而确定或确认近距离命令发布器件,例如如控制器(接收器单元104/106)的身份。例如,在一个方面中,每个发射器单元102、620(图1、图6)均可以具有基于例如器件序列号或标识号的唯一密钥。该值可以锁存或存储,并提供给近距离逻辑,并且当近距离通信完成时,将作为近距离命令数据包的部分的接收密钥值与锁存的唯一密钥进行比较。如果两个值匹配,则对应于密钥匹配的信号设置为很高,表明接收的近距离命令用于接收该命令的发射器单元。
再次参考图13,可以使用超时信号连同位定时计数器1320,从而确定发射错误是否可发生。例如,每当通过发射器单元104/620的近距离逻辑接收有效数据位时,通过位定时计数器逻辑1320生成超时信号。在一个方面中,每个超时信号之间的时间周期通过位定时计数器逻辑1320进行比较,并且如果确定该时间周期大于基于数据位时间的预定时间周期(例如,数据位时间的大约1.75倍),则确定数据发射错误。如果确定该发射错误,则状态机逻辑1360可以被构造成使移位寄存器逻辑1340、序列检测器逻辑1330和位计时器逻辑1320复位。另一方面,当确定数据发射没有错误时,即,当由位定时计数器逻辑1320比较的每个超时信号之间的时间周期低于预定的时间周期时,则与当前数据通信相关的数据位认为有效。
仍参考图13,尤其向曼彻斯特位解码器逻辑1310、位定时计数器逻辑1320和移位寄存器逻辑1340提供时钟信号,从而使在分析物监视系统的发射器单元中的近距离检测器逻辑的组件执行的各种例程的操作同步。另外,以上面描述的方式,近距离检测器逻辑可以被构造成使用以相对较低时钟速率运行的小逻辑块,导致例如需要的ASIC资源和/或功耗的降低。此外,上面描述的近距离检测器逻辑的实施方式提供了独立的连续OOK检测而无需使用需要相对更多的功率和ASIC资源(例如,ASIC面积)的微控制器。
事实上,根据本发明公开内容的实施方式,来自接收器单元(104/106)的发射的OOK数据包可连同接收的近距离命令使用例如曼彻斯特解码块逻辑、检错逻辑和命令解码器逻辑中的一个或更多个来解码。此外,虽然上面描述了曼彻斯特解码器逻辑,但在本发明公开内容的范围内,可以使用其它数据编码/解码技术,例如其它二进制相移键控(BPSK)。
图14是示出了本发明公开内容的一个或多个实施方式中的近距离检测逻辑的流程图。参考图13和图14,当在数据通信系统例如分析物监视系统100(图1)中激活近距离通信模式时,近距离检测器逻辑可以被构造成连续监视,从而检测输入命令或数据信号。当近距离逻辑激活时,开始的初始化发生(1410),以清除数据位,从而确保没有不正确的信号发送到近距离逻辑。近距离检测器逻辑等待接收一个或更多个数据位(1420)。如上面讨论的,曼彻斯特编码数据包可以以4.8千位/秒的速率接收。当没有接收数据时,该逻辑可超时并返回到初始化状态(1410)。
另一方面,当接收数据包时,可执行纠错从而确定接收数据包的有效性(1430)。例如,如上面讨论的,序列检测逻辑可以被构造成分析接收的数据包的打点模式和数据帧,从而确定该数据包是否有效。如果确定分析的打点模式和数据帧导致检测数据模式中的特定序列,则在一个方面中,该例程可返回到复位/初始化状态(1410)。然而,当确定接收的数据包有效时,该数据包例如锁存(1440)在移位寄存器中,如上面讨论的。事实上,在一个方面中,当接收数据包中的第11位时,确定近距离通信完成(1460)。
参考图13和图14,比较近距离密钥从而确认接收的命令用于接收该命令的发射器件(1450)。例如,如上面连同图13讨论的,接收的数据包可以包括唯一的发射器识别信息(例如序列号或其它唯一信息)。该信息可与存储值比较,从而确定接收的信息是否匹配存储的值。如果确定近距离密钥不匹配,则在一个方面中,由于接收的数据包不用于接收包的器件,因此例程返回到初始化/复位状态(1410)。另一方面,如果近距离密钥匹配存储的信息或唯一值,则在一个方面中,状态机逻辑可以被构造成生成确认接收有效近距离通信的OOK信号,并且该状态机逻辑可以被构造成执行请求的功能,或执行与接收的近距离命令相关的一个或更多个例程。
以这种方式,本发明公开内容的实施方式提供了这样的方法和设备,其用于最优化功耗和与器件通信的ASIC资源,例如上面描述的分析物监视系统的发射器单元620或用于注射药物例如胰岛素或其它治疗剂的体上贴片泵。
应当注意,虽然上面描述的示例性实施方式包括具有特定数据包大小、发射速率、移位寄存器的大小、纠错技术等的配置,但在本发明公开内容的范围内,其它合适的变化也是可完全预期的。
在一个方面中的方法包括接收包括一个或更多个检错位、一个或更多近距离命令和通信标识符的编码数据包,解码接收的数据包,基于一个或更多个检错位进行检错,验证解码的接收数据包,以及当验证解码的接收数据包时执行与各自的一个或更多近距离命令相关的一个或更多例程,其中执行的一个或更多例程包括发射分析物相关数据。
接收的数据包可以被曼彻斯特编码。
一个或更多个检错位可以包括预定位模式例如如打点模式。
在另外的方面中,解码接收的数据包可以包括执行曼彻斯特解码。
同样,验证解码的接收数据包可以包括将数据包中的接收的通信标识符与存储值进行比较。
通信表示符可以包括器件(装置)识别信息。
一个或更多个例程可以与分析物监控器件的操作相关。
执行的一个或更多个例程可以包括通电例程、断电例程、数据传输启动例程或数据传输失能例程。
分析物相关数据可以包括监视的分析物水平,例如葡萄糖水平。
在另外的方面中,该方法可以包括存储接收的数据包。
根据另一实施方式的方法包括接收包括近距离命令和通信标识符的编码数据包、解码接收的数据包、验证解码的接收数据包,以及当验证解码的接收数据包时,执行与各自的一个或更多近距离命令相关的一个或更多例程。
在一个方面中,验证解码的接收数据包可以包括将数据包中的接收的通信标识符与存储值进行比较。
此外,验证解码的接收数据包可以包括对数据包进行检错,包括例如将接收的数据包中的一个或更多个数据模式进行比较。
通信标识符可以包括器件(装置)识别信息。
一个或更多例程可以与分析物监视器件的操作相关。
执行的一个或更多例程可以包括通电例程、断电例程、数据传输启动例程或数据传输失能例程。
在另一方面中,该方法可以包括接收与分析物水平相关的信号,其中该分析物包括葡萄糖。
同样,解码的接收数据包可以存储在例如存储器、存储装置(器件)等中。
根据另一实施方式的设备包括通信接口、连接至该通信接口的一个或更多个处理器,以及用于存储指令的存储器,该存储器通过该一个或更多处理器执行时,导致该一个或更多处理器经由通信接口接收包括一个或更多检错位、一个或更多近距离命令和通信标识符的编码数据包,解码接收的数据包,基于一个或更多检错位执行检错,验证解码的接收数据包,并在验证解码的接收数据包时执行与各自的一个或更多近距离命令相关的一个或更多例程,其中执行的一个或更多例程包括发射分析物相关数据。
所述存储器用于存储指令,当被一个或更多处理器执行时,可以使该一个或更多处理器对接收的数据包进行曼彻斯特解码。
一个或更多检错位可以包括预定的位模式,该预定的位模式包括例如打点模式。
所述存储器用于存储指令,当被一个或更多处理器执行时,可以使该一个或更多处理器对接收的数据包进行曼彻斯特解码。
所述存储器用于存储指令,当被一个或更多处理器执行时,可以使该一个或更多处理器将数据包中的接收的通信标识符与存储值进行比较,从而验证接收的数据包。
所述存储器用于存储指令,当被一个或更多处理器执行时,可以使该一个或更多处理器在该存储器中存储接收的数据。
一个或更多处理器可以包括专用集成电路(ASIC)。
以描述的方式,根据本发明公开内容的实施方式,近距离检测器逻辑可以被构造成使用以相对较慢的时钟速率运行的小逻辑块,导致例如需要的ASIC面积和功耗的降低。此外,上面描述的近距离检测器逻辑的实施方式提供了独立连续的OOK检测而无需使用需要相对更多功率和ASIC资源的微控制器。
在不背离本发明的范围和精神的情况下,本发明的结构和操作方法中的各种其它修改和替换对于本领域技术人员来说将是显而易见的。尽管已经连同具体的优选实施方式描述了本发明,但应当理解,如要求保护的本发明不应不适当地限于这样的具体实施方式。本发明旨在由所附的权利要求限定本发明公开内容的范围,并且由此覆盖在这些权利要求的范围内的结构和方法以及它们的等同物。

Claims (35)

1.一种通信方法,包括:
通过将控制单元放置在距离数据处理单元预定距离的范围内,在所述数据处理单元和所述控制单元之间建立通信范围;
当所述控制单元在所述预定距离范围内时,在所述数据处理单元处接收编码数据包,其中,所接收的编码数据包包括一个或更多检错位、一个或更多激活命令和通信标识符;
解码所接收的数据包;
基于所述一个或更多检错位进行检错;
验证所解码的接收数据包;以及
当验证所解码的接收数据包时,执行与各自的一个或更多激活命令相关的一个或更多例程,其中所述激活命令配置为控制分析物相关数据的传送或处理;
其中所执行的一个或更多例程包括激活所述数据处理单元以传送所述分析物相关数据。
2.根据权利要求1所述的方法,其中,所述一个或更多检错位包括预定的位模式。
3.根据权利要求2所述的方法,其中,所述预定的位模式包括打点模式。
4.根据权利要求1所述的方法,其中,解码所接收的数据包包括进行曼彻斯特解码。
5.根据权利要求1所述的方法,其中,验证所解码的接收数据包包括将所述数据包中的所接收的通信标识符与存储值进行比较。
6.根据权利要求1所述的方法,其中,所述通信标识符包括器件识别信息。
7.根据权利要求1所述的方法,其中,所述一个或更多例程与分析物监视器件的操作相关。
8.根据权利要求1所述的方法,其中,所述执行的一个或更多例程包括通电例程、断电例程、数据传输启动例程、或数据传输失能例程。
9.根据权利要求1所述的方法,其中,所述分析物相关数据包括监视的分析物水平。
10.根据权利要求9所述的方法,其中,所述分析物是葡萄糖。
11.根据权利要求1所述的方法,包括存储所接收的数据包。
12.一种通信方法,包括:
通过将控制单元放置在距离数据处理单元预定距离的范围内,在所述数据处理单元和所述控制单元之间建立通信范围;
当所述控制单元在所述预定距离范围内时,在所述数据处理单元处接收编码数据包,其中,所接收的编码数据包包括一个或更多检错位、一个或更多激活命令和通信标识符;
解码所接收的数据包;
基于所述一个或更多检错位,执行检错;
验证所解码的接收数据包;以及
当验证所解码的接收数据包时,执行与各自的一个或更多激活命令相关的一个或更多例程;
其中,所执行的一个或更多例程包括发射分析物相关数据。
13.根据权利要求12所述的方法,其中,对所接收的数据包进行曼彻斯特编码。
14.根据权利要求12所述的方法,其中,解码所接收的数据包包括进行曼彻斯特解码。
15.根据权利要求12所述的方法,其中,验证所解码的接收数据包包括将所述数据包中的所接收的通信标识符与存储值进行比较。
16.根据权利要求12所述的方法,其中,验证所解码的接收数据包包括对所述数据包进行检错。
17.根据权利要求16所述的方法,其中,进行检错包括比较所接收的数据包中的一个或更多数据模式。
18.根据权利要求12所述的方法,其中,所述通信标识符包括器件识别信息。
19.根据权利要求12所述的方法,其中,所述一个或更多例程与分析物监视器件的操作相关。
20.根据权利要求12所述的方法,其中,执行的一个或更多例程包括通电例程、断电例程、数据传输启动例程、或数据传输失能例程。
21.根据权利要求12所述的方法,包括接收与分析物水平相关的信号。
22.根据权利要求21所述的方法,其中,所述分析物是葡萄糖。
23.根据权利要求12所述的方法,包括存储所解码的接收数据包。
24.一种通信设备,包括:
通信接口;
连接至所述通信接口的一个或更多处理器;以及
存储器,用于存储指令,当所述指令被所述一个或更多处理器执行时,使所述一个或更多处理器在控制单元位于距离数据处理单元预定距离的范围内时,在所述数据处理单元和所述控制单元之间建立通信范围,当所述控制单元位于所述预定距离内时,在所述数据处理单元处经由所述通信接口接收编码数据包,其中,所接收的编码数据包包括一个或更多检错位、一个或更多激活命令和通信标识符,解码所接收的数据包,基于所述一个或更多检错位进行检错,验证所解码的接收数据包,以及当验证所解码的接收数据包时,执行与各自的一个或更多激活命令相关的一个或更多例程,其中所述激活命令配置为控制分析物相关数据的传送或处理,其中所执行的一个或更多例程包括激活所述数据处理单元以传送所述分析物相关数据。
25.根据权利要求24所述的设备,进一步使所述一个或更多处理器曼彻斯特解码所接收的数据包。
26.根据权利要求24所述的设备,其中,所述一个或更多检错位包括预定的位模式。
27.根据权利要求26所述的设备,其中,所述预定的位模式包括打点模式。
28.根据权利要求24所述的设备,进一步使所述一个或更多处理器在所解码的接收数据包被验证时,执行与各自的一个或更多激活命令相关的一个或更多例程。
29.根据权利要求24所述的设备,进一步使所述一个或更多处理器将所述数据包中的所接收的通信标识符与存储值进行比较,从而验证所接收的数据包。
30.根据权利要求24所述的设备,其中,所述通信标识符包括器件识别信息。
31.根据权利要求24所述的设备,其中,所述执行的一个或更多例程包括通电例程、断电例程、数据传输启动例程、或数据传输失能例程。
32.根据权利要求24所述的设备,其中,所述分析物相关数据包括监视的分析物水平。
33.根据权利要求32所述的设备,其中,所述分析物是葡萄糖。
34.根据权利要求24所述的设备,进一步使所述一个或更多处理器在所述存储器中存储所接收的数据包。
35.根据权利要求24所述的设备,其中,所述一个或更多处理器包括专用集成电路(ASIC)。
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