CN1722186A - 监控分析物浓度的方法 - Google Patents
监控分析物浓度的方法 Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
Abstract
公开了一种用于由一个或多个其它人员远距离监控个人的分析物浓度的方法。
Description
技术领域
本发明涉及由一个或多个其它人员远距离监控个人分析物浓度的方法。
背景技术
存在以连续或经常、定期的方式测量和监控分析物的浓度的要求。例如,某些糖尿病患者受益于一种无需人为干涉而能连续和自动测量葡萄糖浓度的系统。现有各种这类系统,包括具有永久或暂时植入的传感器或能建立连续接触患者的血液或组织间液的传感器的系统。这些系统向患者提供实时的葡萄糖浓度。
这些系统都已考虑包括有报警机制,当用户的葡萄糖浓度超出生理正常范围时,报警机制自动启动来通知用户。这对于糖尿病患者的夜间监控特别有用。在这种情况下,当患者进入低血糖或高血糖状态时,连续葡萄糖传感器就启动声音报警器(或者设置传感器本身中或者设置在与传感器有线或无线连接的分开的但在其附近的装置上),将糖尿病患者唤醒,以便进行适当的治疗。但在某些情况下,报警器不足以唤醒患者,特别是在糖尿病患者不能轻易被唤醒或因低血糖或高血糖情况而已进入昏迷状态的情况下。如果糖尿病患者是婴儿或非常小的孩子,或有身体或智力残疾不能自己对报警器作出响应,这种报警器也没有用。在这种情况下,父母或其它护理人员必须经常和定期对糖尿病患者作检查来监控其葡萄糖浓度。
虽然无线技术已可用来远程设置报警器,例如设置在父母或护理员的卧室中,但由于联邦通信委员会(FCC)的规定,要求这些类型的传感器系统使用非常低的发射频率,这就将报警器的位置限制在距传感器不能超过几米远。低频装置,特别是它们的天线都必须较大。另一方面,能发射高频(大约100MHz以上)的传感器-报警器系统会受到人体的干扰,因而具有有限的传输距离能力,特别是在室内。此外,高频无线信号会消耗大量的电能,需要的电池尺寸较大,这就限制了报警器单元的便携性。
所以,一直需要开发能解决目前技术不足的、且便于远程监控实时分析物浓度和其它生理特征的新装置和技术。
发明内容
本发明针对监控分析物的方法,这些方法满足远程监控患者和远程发送患者数据和/或启动报警器的需要,排除先有系统的缺点和不足。而且,所述方法利用的系统消耗极少功率,可提供较长距离的信号传输,且比传统的分析物监控系统较少受人体的干扰。
分析物监控系统包括:用于监控用户分析物浓度的传感器;信号中继器;以及信号接收器。除了监控分析物浓度外,传感器配置成将第一无线信号发送到信号中继器,所述信号表示实时分析物浓度,例如表示当前葡萄糖浓度或一种生理状态(例如低血糖或高血糖)的数值。信号中继器配置成接收第一无线信号,并继而将表示这种浓度或状态的第二无线信号传送到信号接收器,第二无线信号具有不同于第一无线信号的频率和/或传输协议(即包括但不限于信号发送和接收时间和数据分组)。信号接收器配置成接收第二无线信号并通知用户有关实际的实时分析物浓度、传感器状态(功能状态、故障出现、误码等等),或表示它们的状态等。这种通知可以是听觉的、触觉的和/或视觉的报警,还可包括实际分析物浓度值的显示。所以,本发明的分析物监控系统可以通过使用第一频率与传感器通信将报警信号发送到较近距离的中继器上,随后利用第二频率与中继器通信将报警信号发送到较远距离的接收装置上。两个信号可以具有相同或不同的频率。如果使用相同的频率,信号通常具有互不干扰的不同的传输协议。
本发明的方法针对以下目标:通过至少一个第二者来监控第一人的分析物浓度。所述方法包括测量第一人的分析物浓度并发送表示分析物浓度值实时状态的无线信号。然后将表示所述分析物浓度值所具有的分析物浓度实时状态的第二无线信号发送到至少一个第二者的位置。第二信号的传输距离大于第一信号的传输距离。
本发明的另一方法针对以下目标:通过至少一个第二者来中继第一人的实时分析物浓度值。所述方法包括:利用传感器测量第一人的分析物浓度;以及将表示分析物浓度实时状态的第一无线信号从传感器发射到位于距传感器第一距离的手持装置上。然后将表示浓度值的第二无线信号从手持装置发送到位于距传感器第二距离的中继器上。然后将第三无线信号从中继器发送到位于距传感器第三距离的信号接收器上,第三无线信号的传输距离大于第一无线信号的传输距离。
对于本专业的技术人员来说,在阅读了以下详细说明的本发明的细节之后,将明白本发明的这些和其它目的、优点和特征。
附图说明
结合附图阅读以下的详细说明可以更好地理解本发明,附图中:
图1是本发明的分析物监控系统第一实施例的示意图。
图2是本发明的分析物监控系统第二实施例的示意图。
具体实施方式
在说明主体系统和方法之前,应理解本发明不限于所述和图示的具体实施例,它们当然可以改动。还应理解本文所用的词语仅是为了说明具体实施例,而不是为了限制,本发明的范围仅受所附权利要求书的限制。
在提出数值范围时,应理解,在所述范围上下限之间的每个介入值,直到下限单位的十分之一(除非文中另有明确说明),也都被具体公开。所述范围内的任何所述数值或介入值与所述范围的任何其它所述值或介入值之间的每个较小的范围都被包括在本发明内。这些较小范围的上下限可以独立地被包括在或不包括在所述范围内,并且所述较小范围内包括所述上限和下限中任一个、不包括所述上下限或包括所述上限和下限两者的每个范围也都包括在本发明之内,根据所述范围内任何被具体排除的极限而定。在所述范围包括一个极限或两个极限时,排除了任一个或二个所包括的极限的范围也包括在本发明之内。
除非另有定义,本文中所用的全部科技术语具有本发明所属技术领域一般技术人员通常理解的相同的含义。
应指出,在本文中和所附权利要求书中所用的单数形式”a”、”an”和”the”等也包括多数,除非文中另有明确说明。所以,例如,涉及”asignal”包括多个这种信号,依此类推。
本文提到的所有出版物都作为参考包括在本文中,以公开和说明与所引述出版物相关的方法和/或设备。本文所讨论的出版物完全是在本发明提交日之前的公开内容。也不应认为这是承认由于先有的发明本发明无权发生在这些出版物之前。而且,所提供的出版物日期可能与实际的出版物日期不同,需要独立地确认。
现将详细说明本发明的示范实施例和各种改型。在进一步说明本发明时,首先要说明主体系统和装置部件。其次,将说明使用所述主体装置和系统的各种方法以及传送实时生理信息的方法。最后,简要地说明主题套件,这些套件包括用于实施主体方法的主体装置和系统。
在以下的说明中,将用葡萄糖浓度测量来说明本发明,但这并不是在进行限制,本专业的技术人员应理解所述主体装置、系统和方法在测量和监控其它身体、神经学和化学特征方面,例如血压、心率、呼吸率、神经活动、治疗药物水平、胚胎活动、睡眠状态等,都很有用。
图1是本发明的分析物监控系统实施例的示意图。分析物监控系统包括分析物传感器100、信号中继器4和信号接收装置6。
传感器100可以是任何类型的传感器,包括但不限于:可以永久或暂时植入皮下、皮肤、皮肤下、腹膜内、腹膜组织或佩戴在或附着在身体上,允许连续或间断测量和利用户的血液、组织间液等的传感器。传感器可以是电化学的、化学的或光学的传感器等。在美国专利6,040,194;6,232,130;6,233,471;6,272,364;6,329,161;6,514,718;6,558,321和6,702,857中以及国际公开WO 02/49507中公开了可用于本发明的传感器实例,这些已作为参考全部包括在本文内。可用于本发明的市售传感器实例包括但不限于:Gluco WatchG2Biographer,由Cygnus,Inc.,Redwood City,CA生产;以及CGMSSystem GoldTM,由Medtronic Minimed,Inc.,Northridge,CA.生产。
传感器100可包括集成信号发射器,或直接连接到传感器读出部分的信号发射器。发射器最好配置成在射频(RF)范围内发射信号。传感器还包括处理器,后者可以被编程为使所述传感器能够对目标分析物进行连续或间断而频繁的测量,并连续或间断地发射表示这些测量值的信号。用不可植入或部分可植入的传感器时,可将传感器本身配置成向用户提供指示低于可接受的测量值的报警信号。用可植入的传感器时,可将传感器配置成发射信号来启动用户附近的外部报警器。此外,传感器的处理器还能够检测传感器的故障,例如,由电池电能低、温度过高/低、传感器与用户分离等引起的故障,并发送表示这些故障的报警信息。
信号中继器4包括信号接收部分和发射部分,接收部分配置成接收来自传感器100的发射信号,发射部分配置成将信号发送到信号接收器6。接收和发射部分最好还配置成在RF频段工作。中继器4还配置成将具有一种频率和/或传输协议的所接收信号转换成具有另一频率和/或传输协议的信号,并将传输距离大于所接收信号的传输距离的已转换信号发射出去。可用于本发明的合适的中继器包括Millenial Net Inc.和ZigBee,Inc.所生产的中继器。
根据用户的设置,中继器4可以用作固定的和/或便携式装置。例如,中继器4可以结合到基本上固定的基本单元或基站中,如图1所示,可由指定的电源供电,或用导线或电缆连接到传统的AC插座上。由于传感器100所发射信号的能量较低,将中继器4设置在位于距传感器100大约3米处可获得较好的结果。在本发明的一个实施例中,中继器4可以设置在糖尿病患者居住的室内的适当位置。或者,如图2所示,中继器4可以配置成与手持的、电池供电的单元2连接。手持装置2可以配置成以模块形式利用电插座连接器(例如USB端口)与中继器4配对,其中装置2将信息(信号)传送到中继器4,而中继器4由装置2供电。或者,中继器4可以在电气上结合到手持单元2中。
手持装置2还可以具有电子功能,以便以单次方式利用一次性葡萄糖试纸来测量诸如葡萄糖等分析物浓度。可以包括到手持装置2中的单次葡萄糖计是市售的LifeScan OneTouchUltraSmartTM监控系统。在某些情况下,除了连续方法外,还需要单次性测量葡萄糖的系统。例如,可能需要进行单次葡萄糖测量来协助校准传感器100,进行质量控制检查、当传感器100正在平衡时进行紧急葡萄糖测量测试或者在采取剧烈的治疗行动前确认传感器100产生的极高或极低的测量值。在本发明的另一实施例中,手持装置2可以用作发送和接收来自传感器100的数据的遥控装置、胰岛素泵(未示出)或其它医学装置。
在上述任一种中继器配置中,基本单元或手持单元或二者可以包括用于控制传感器功能的用户接口控制装置和用于显示分析物数值和其它系统参数的显示器。所述单元通常还包括主报警器,例如听觉、触觉(振动)和/或视觉报警信号,以通知用户严重状态或潜在的严重状态。由于中继器4有AC电源,它可产生比完全由传感器100所产生的报警更强的报警,例如更响的噪声或更亮的光,以帮助提醒糖尿病用户。如果传感器100和胰岛素泵结合使用作为闭环或反馈控制系统的一部分,用以控制提供适当剂量的胰岛素来维持正常的血糖状态,可能就不需要这种报警器。但是,如果不采用这种闭环系统,当用户的葡萄糖浓度已达临界值时,单独的主报警器就不足以唤醒用户。
信号接收器6配置成接收来自中继器4的较高能量的信号,它可以设置在远离中继器4的地方,其距离可比中继器4距传感器100的距离更远,即,大于3米。接收装置6如果设置在第二者或用户(如父母,护理员,护士等)所在的位置或房间内(例如卧室或护士站),就可以配置成固定的。固定的接收器可以电池供电或通过AC插座电源供电。或者,接收装置6可以是便携式电池供电的装置,配置成由第二者例如用皮带扣或通过袖箍佩戴或携带。
在上述任一种信号接收器的配置中,接收器提供第二系统报警,例如听觉、触觉(振动)和/或视觉(例如一个或多个闪烁发光二极管(LED)报警机构,当分析物浓度超出生理正常范围时所述报警机构就被启动。这样,第二者立即被提醒主用户(例如糖尿病患者)正在经历严重或潜在的严重状态。在一个实施例中,声音报警器可以配置成根据当时情况的紧急程度和类型发出不同音量(分贝)的声音。例如,较为严重的情况,例如主用户的葡萄糖浓度已进入生理临界区,就会发出非常响的报警。或者,报警器的声音可以是录制的声音,用文字宣布主用户的实时状态,如”紧急”,”注意”等。声音的类型也可根据需要报警的情况而各不相同。例如,发出嘟嘟声表示主用户的生理状态,而发出嗡嗡声表示系统问题,例如电池不足,信号接收丢失等。视觉信号可以配置成发出多种颜色,例如绿色表示主用户处于正常状态、黄色表示主用户处于或进入潜在高/低血糖区、红色表示主用户的葡萄糖浓度已进入不安全的高/低血糖区,而蓝光表示系统故障或问题。
接收装置6还可包括显示器,例如液晶显示器(LCD),显示有关主用户的定量或定性的实时或存储的主用户信息数据,例如,主用户葡萄糖浓度的实时测量值或数次最近所作的测量值等。所述显示器还可以提供有关系统参数的信息,例如,剩余的电池能量、信号接收电平等。有了基本单元或手持单元与中继器4关联,信号接收器6就可提供用户接口控制,如功能菜单、音量调节等。
这样配置后,本发明的系统就能将无线信号(即报警信号以及表示分析物测量和系统工作参数的信息)从传感器100经信号中继器4发送到信号接收装置6。换句话说,中继器4用作向远离被监控个体的人发送信息的管道。系统可包括设置在不同位置的一个或多个信号接收器以便将信息发送给不止一个人。在此文所讨论的应用中,主体系统提供了方便的途径以无线方式提醒更多的第二者有关被监控的糖尿病患者的血糖状态。
通常被监控个体和第二者之间的距离大约为30到100米,但根据用户所在建筑物(例如家里,医院病房等)的大小或面积可更大或更小。这样一种传输距离需要的信号传输频率大于传感器100所允许的频率范围。尽管有限制医学传感器频率范围的联邦规定,但实用性也要求传感器100的体积应较小,例如不大于几个立方厘米,特别是要植入的话,所以安装电池或有效天线的空间容量也很有限。于是,只有低能量输出的非常小的电池才适用于传感器100。由于电源有限,传感器100的信号传输距离就受限,且传感器100所传输的信号能量也比较低,例如不大于数百微瓦。
按照本发明,采用信号中继器4来补偿传感器100有限的传输距离。信号中继器4不植入人体,在某些实施例中不由主用户佩戴,它没有传感器100的尺寸、空间、传输距离和电能等限制。这样,中继器4可用较大的电源并能够以较高的能量在较长的距离上传输信号。虽然较高的能量更易于被人体吸收,但中继器是在远处,足以减小这种吸收。
传感器100利用具有第一频率8a并采用第一传输协议的第一传输信号与中继器4进行无线通信,中继器4利用具有第二频率8b并采用第二传输协议的第二传输信号与信号接收器6进行无线通信。如果二者使用相同的频率,则两个传输协议不同,反之亦然。或者,两个频率和两种传输协议都不同。用任一实施例,第一频率8a足以允许在不大于3米的距离范围内进行从传感器100到中继器4的无线传输,而第二频率8b足以允许在大于3米的距离(最典型的是可达30到100米)范围内进行中继器4与接收器6之间的无线传输。当然,必要时,通过使用一个或多个顺序地彼此间隔设置的中继器,总传输距离还可延长。
在图2的实施例中,手持装置2可以利用具有第三频率8c并采用第三传输协议的第三传输信号与中继器4无线通信,第三传输信号足以允许在类似于传感器100和中继器4之间的距离上在单元2和中继器4之间进行无线通信,但所述距离可以更大或更小。第三传输信号可以具有和第一信号相同或不同的频率和/或使用和第一信号相同或不同的传输协议。
实际上,在无线电频谱内的信号更适用于本发明。通常,本发明中所使用的传输信号频率在大约200MHz到2.4GHz范围内。在一种变型中,第一和/或第三频率8a和8c通常在200MHz到950MHz范围内,而第二频率8b大约为2.4GHz(该频率能够使用802.11无线标准),但可根据应用情况更高或更低。在一个实施例中,第一和第三频率中任一个或二者是大约903MHz(所述频率可以作为未发执照的无线电频谱的一部分使用)。
在所述系统中的无线通信可以完全是单方向的,即从传感器到中继器到接收器,或完全是双向的,即接收器能够发送到中继器,中继器能够发送到传感器,或系统是部分单向和部分双向的,例如传感器和中继器或手持单元之间的通信是双向的,而中继器和信号接收器之间的通信是单向的。以与本文中起初所述的方向相反的方向(即从接收器到中继器以及从中继器到传感器的传输)传输的信号频率可与8a、8b和8c分别相同或不同。
本发明还包括由至少一个第二者监控第一人分析物浓度的方法。在一种方案中,所述方法涉及测量第一人的分析物浓度,例如用上述的传感器100,然后将表示分析物浓度实时状态的低能量无线信号和/或反映这种状态的报警信号发送到中继站,例如利用上述中继器4(和/或发送到手持或基本单元2),在此它被转换成较高能量的无线信号。然后将较高能量的信号发送到第二者的位置并在第二位置由信号接收器(例如上述信号接收器6)接收。对超出可接受范围的第一人的分析物浓度作出响应,信号接收器上的报警器被启动来提醒第二者,此外,传感器和/或中继器和/或手持单元可具有各自的报警器,在类似的情况下可被启动。
在图2的实施例的情况下,第一无线信号可同时发送给手持单元2和中继器4两者,或者,可以首先发送给其中一个,然后它再发送第二无线信号给另一个。通常是将第一信号发送到手持单元,手持单元再将其发送到中继器。如上所述,手持单元可以发送与传感器相同或不同频率的信号。
本发明的一个优点在于第一频率范围要求较低的功率,并且比较不容易受可能设置有传感器100的人体的干扰。低功率要求还有一个优点就是它允许传感器100具有较小的电池和/或不太频繁的电池充电/更换,这对植入的和可佩戴的连续传感器是非常必要的。但如上述,较低能量的信号一般会使传输距离受到限制。所以使用中继器4来中继从传感器100到接收装置6的信号传输。
本发明的另一优点是第二频率8b允许有更大的传输距离。虽然第二频率8b比第一频率8a需要更多的电能,但使用利用AC电源或具有较高能量输出的大电池的固定中继器4缓和了功率问题。应指出,使用较高能量的信号更易于和人体发生生理干扰,但由于中继器4通常远离人体,所以一般不成问题。
本发明还提出了用于实现本发明方法的套件。在本发明的一个实施例中,所述套件包括至少一个传感器、中继器和至少一个接收器,如上所述。套件还可包括录制在CD-ROM等上的软件程序,所述程序可以由用户或医生利用外部装置,例如计算机,下载到传感器、基本单元或手持单元或测量计、和/或信号接收器上。最后所述套件还可包括装置的使用说明。这些说明可以在套件内一个或多个包装物上,在标签或容器上,或者可以通过CD-R0M等提供。
从以上说明和讨论可见,本发明提供了一种简单方便的方法来无线提醒一个或多个第二者有关被监控的糖尿病患者的实时葡萄糖状态。所以,本发明对本领域作出了重要的贡献。
虽然已用图示和实例对上述发明作了详细的说明以便清楚理解本发明,但是,显然,对于本专业的技术人员而言,根据本发明的内容在不背离所附权利要求书的精神和范围的前提下可以作出某些变化和修改。
Claims (13)
1.一种由至少一个第二者监控第一人的分析物浓度的方法,所述方法包括:
测量所述第一人的所述分析物浓度;
发射表示所述分析物浓度实时状态的第一无线信号,所述第一无线信号具有第一传输距离;以及
将表示所述分析物浓度实时状态的第二无线信号发射到所述至少一个第二者的位置,所述第二无线信号具有第二传输距离;
其中所述第二传输距离大于所述第一传输距离。
2.如权利要求1所述的方法,其中所述第一无线信号的信号频率在从大约200MHz到大约950MHz的范围内,而所述第二无线信号的信号频率为大约2.4GHz。
3.如权利要求1或2所述的方法,其中所述第一无线信号的传输距离为大约3米或小于3米,而所述第二无线信号的传输距离为大约30米或大于30米。
4.如权利要求1,2或3所述的方法,其中还包括在所述至少一个第二者的位置上启动报警器以便对所述分析物浓度的所述实时状态作出响应。
5.如权利要求4所述的方法,其中还包括在所述第一人的位置上启动报警器以对所述分析物浓度的所述实时状态作出响应。
6.如上述权利要求中任一项所述的方法,其中连续地进行所述分析物测量。
7.如权利要求6所述的方法,其中还以单一事件的方式进行所述分析物测量。
8.一种由至少一个第二者中继第一人的实时分析物浓度的方法,所述方法包括:
用传感器测量所述第一人的所述分析物浓度;
将表示所述分析物浓度实时状态的第一无线信号从所述传感器发射到位于距所述传感器第一距离的手持装置,所述第一信号具有第一传输距离;以及
将表示所述分析物浓度实时状态的第二无线信号从所述手持装置发射到位于距所述传感器第二距离的中继器,所述第二信号具有第二传输距离;以及
将表示所述分析物浓度实时状态的第三无线信号从所述中继器发射到位于距所述传感器第三距离的至少一个信号接收器,其中所述第三无线信号的传输距离不同于所述第一无线信号的所述传输距离。
9.如权利要求8所述的方法,其中还包括在所述至少一个第二者的位置上启动报警器以对所述分析物浓度的所述实时状态作出响应。
10.如权利要求8或9所述的方法,其中所述第三距离显著大于所述第一距离。
11.如权利要求8、9或10所述的方法,其中所述第一距离和所述第二距离基本上相等。
12.如权利要求8、9或10所述的方法,其中所述第三无线信号的信号频率大于所述第二无线信号的信号频率。
13.如权利要求8、9或10所述的方法,其中所述第三无线信号的传输协议不同于所述第二无线信号的传输协议。
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CN111295902A (zh) * | 2017-10-31 | 2020-06-16 | 住友电气工业株式会社 | 无线传感器系统、管理设备、通信控制方法以及通信控制程序 |
CN111295902B (zh) * | 2017-10-31 | 2024-03-15 | 住友电气工业株式会社 | 无线传感器系统、管理设备、通信控制方法以及通信控制程序 |
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KR20060049251A (ko) | 2006-05-18 |
TW200622950A (en) | 2006-07-01 |
US20060001538A1 (en) | 2006-01-05 |
EP1611839A1 (en) | 2006-01-04 |
AU2005202514A1 (en) | 2006-01-19 |
CA2510819A1 (en) | 2005-12-30 |
JP2006015146A (ja) | 2006-01-19 |
SG118408A1 (en) | 2006-01-27 |
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