CN100444784C - 用于监测、分析和通信生理状态的可佩带的无线装置 - Google Patents
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Abstract
可佩带的紧凑的、重量轻的、非侵入的、可佩带的“统一的”装置或系统(10),其不损害使用者的运动和灵活性,检测、处理、分析和报告人体的预先确定的生理情况。该系统包括至少一对感测电极(14)和一个参考电极(16),每个构造为粘附地接附到身体(30)的表面。电子模块(12)与每个电极电通信,包括电源,并且处理和分析电极提供的信号。该多个电极和电子模块被单一的粘性的膜(20)覆盖,以使得该可佩带的装置能够附着到身体的表面。
Description
本发明一般地涉及用于监测和分析生理状况的可佩带的无线装置,并且更特别地涉及用于检测和分析生理数据并且发送状态数据的可佩带的无线装置,该装置构造为粘附地接附到该装置的佩带者。
监测个体的生理情况使得能够迅速检测潜在地危及生命的事件,特别是那些可以由某些趋势预知的。为了能够更加连续地监测,已经开发出能够佩带在身体上的装置。
然而,佩带在人的身体上的监测或报警装置必须克服某些设计难题。通常,佩带在身体上的装置必须小并且重量轻,使得人可以在不妨碍运动和灵活性的情况下舒适地佩带该装置。
特别地,通常在医院中在病床边使用标准电极和电极监测技术实行心电图监测。电极厂商提供单独地接附并且能够佩带达到7天的粘性的电极。
已知的一种类型的心电图监测装置,Holter监测器,连续地监测心电图信号,但是通常仅可以连续地监测1到2天,并且需要体积大的装置和麻烦的电缆。更特定地,Holter为通常以两种不同形式出现的心电图记录装置-小的便携式的磁带记录器(像随身听),或形状像寻呼机的小的数字装置。使用者将该装置佩带在围绕他/她的腰部的皮带上,并且4或6根心电图导线从该装置延伸并且粘在使用者的胸部。该装置记录使用者的心脏的电活动24到48小时(或者如果使用数字装置的话达到7天)。医生可以随后分析心脏的电活动和节律以检测任何心律失常。
除了基于使用Holter监测器的尺寸和笨重存在的问题,这样的装置产生的再一个复杂化为从电极通向记录装置的电缆的运动干扰电极/皮肤接触面,由此导致监测假象。
除了心电图监测,Holter装置已知为还提供自动除纤颤-同样,这些装置麻烦并且存在上述相同问题。
最后,用植入装置也可能实现长期心电图监测和循环记录,但是这些不提供对特定的心脏的心律失常的报警,并且此外还需要通过外科手术将其放置在病人身上。替代地,循环存储监测器可以用具有在很长的一段时间期间粘到皮肤的粘性的背衬的两个电极接附到胸部。然而,在这样的装置中,电极在它们上面具有卡扣件,使得来自监测器的导线能够卡在电极上,使得在沐浴或游泳期间,可以将不防水的电子监测装置拆下,但是将粘性的电极保留在胸部上。
因此,本发明针对开发紧凑的、重量轻的、非侵入的、可佩带的“统一的”装置或系统的问题,该装置或系统不损害使用者的运动和灵活性,用于监测和分析该装置的佩带者的生理状况并且在检测到报警状况时通信报警状况(或身体状态)。
本发明通过提供用于检测、处理、分析和报告人体的预先确定的身体情况的可佩带的装置解决这些和其它问题。该装置包括多个电极,包括至少一对感测电极和参考电极,每个构造为粘附地接附到身体的表面。该装置的电子模块与每个电极电通信,包括电源,并且处理和分析电极提供的信号。根据本发明,多个电极和电子模块被使得该可佩带的装置能够附着到身体的表面的单一的粘性的膜覆盖。
根据本发明的一个实施例,电子模块包括无线发送机,并且当该电子模块检测到预先确定的状况时,无线发送机发送报警状态。
在本发明的再一个实施例中,电子模块包括电池。
参考电极可以为分开的电极,或者可以与电子模块整体地形成。电子模块还可以具有多个形成在其顶部和底部表面上或仅形成在其底部表面上的多个导电垫。
在本发明的再一个实施例中,该对感测电极和参考电极集成到通气的布料母体(cloth matrix)上,并且在再一个实施例中,通气的布料母体在所述布料母体的顶部表面和底部表面上包括电极凝胶。参考电极可以定位在通气的布料母体上该对感测电极之间,并且感测电极可以分开至少2英寸。
本发明具有包括在无线发送报警状态之前将指示报警状态被指示的本地报警提供给佩带该装置的人的实施例的优点。另外,一个实施例提供具有包括可以被操作以便防止该装置无线发送对该报警状态的进一步的指示的去启动机构的优点的装置。
在最后说明的实施例中,用于检测、处理、分析和报告生理状况的设备包括多个构造为粘附地接附到人体表面用于检测生理数据的电极和与该多个电极中的每个电通信的处理器,该处理器分析并且处理该多个电极提供的信号,形成生理输出数据。电极和处理器在适合附着在人体上的单一的柔性的粘性的材料的界限内安装在一起,使得电极和处理器避免妨碍人体的运动和灵活性。
这些和其它优点将通过审阅根据接下来的附图进行的详细描述显而易见。
图1示出了根据本发明的一个方面的用于监测佩带者的生理状况的装置的示例性的实施例。
图2示出了根据本发明的另一个方面的用于监测佩带者的生理状况的装置的另一个示例性的实施例。
需要注意,在这里对“一个实施例”或“实施例”的任何引用意味着与该实施例有关地描述的特别的特点、结构、或特征包括在本发明的至少一个实施例中。在说明书中不同的位置出现的用语“在一个实施例中”不是必须都指的是同一个实施例。
根据本发明的装置在将感测和参考电极、电子信号获取、处理和分析、电源、和报警状况的发送全部结合在可以粘附地施加到身体的表面的统一的系统内这一点上是独特的。没有其它系统的元件需要被放置在病人身上或靠近病人。用于分析不同的生理状况、和发报警或状态状况信号的各种算法可以配置在此平台上。根据本发明的装置或系统提供对病人舒适、装置不显眼、本地信号处理和判定、和报警状况的无线发送、提供在对不常见的但是危及生命的事件的活动的监测中的突破的独特的结合。该装置可以在躯干的左前和左侧表面上的不同的位置处附着到人体上,并且固此,如果对于特别的使用者存在皮肤刺激的问题,该装置可以根据需要重新定位以避免严重的炎症。另外,左前和侧胸上的大的心电图梯度允许用相对小的装置获得相对大的信号。
图1示出了根据本发明的可佩带的监测系统10的透视图。示出为施加到人的皮肤30的系统10的元件被包含在粘性的膜20内(或被粘性的膜20覆盖),并且包括电子模块12(电子模块12在其顶部表面上包括两个镀银的导电垫13)、至少两个感测电极14、和至少一个参考电极16。
在此特别的实施例中,粘性的膜20携带随后如图1所示附着到电子模块12的导电垫13的两个感测电极14(如接下来提到的,Ag/AgCl化学物质是优选的),或两个感侧电极14接附到粘性的膜20。
电子模块12包括电源(优选为电池),并且可以包含放大器、模拟滤波器、A/D转换器、微处理器、存储器、发送机和被系统10用于无线通信的天线。
电子模块12的一个优选的实施例将其中用于感测电极14的放大器尽可能靠近参考电极16放置以获得有源电极的已知的优点。相似地,阻抗非常高的放大器可以用于电子模块12以最小化皮肤与电极接触的变化的影响,并且最小化共模电流。参考电极16对信号地具有非常低的阻抗,使得大部分共模电流通过参考电极16,最小化引入差动信号的共模噪声。
电子模块12接收来自用于监测至少一个生理状况的感测电极14的信号并且处理和分析该输出。本领域中的普通技术人员应该理解,用于分析不同的生理状况、和发报警或状态状况信号的各种算法可以用于提出的装置。例如,在本发明的装置的一个示例性的实施例中,在题目为“Staged Life-Threatening Arrhythmia Detect ion Algorithm forMinimizing Power Consumption”【Philips发明披露物No.779978】的共同转让的申请中描述了可以实现为电子模块12的处理部分的某些方面,该申请如在这里包括附图全文重复地作为参考加入。其中,图1提供了处理部分的示例性的实施例的方框图。根据此实施例,算法的第一阶段将检测危及生命的心律失常并且可以实现不同等级的预先确定的“报警状况”。例如,低等级的警报可以用于指示检测到一个或多个与心脏监测装置的技术方面有关的状况,中间等级的警报可以用于指示已经在病人体内检测到可以不需要立即医疗的医学状况,并且高等级的警报可以用于指示已经检测到危及生命的医学状况。
电子模块12内的模拟滤波器用于消除可以混淆到数字化后的信号频带内的频率。随后通过微处理器分析数字化的信号,微处理器检测报警状况(例如,在心电图的情况下的心室纤颤)并且产生报警信号,报警信号可以随后无线通信到监测站(同样可以使用任何众所周知的无线技术实现报警信号的通信)。
另外,可选地,电子模块12上的报警(例如,“听得见的”报警)可以警告佩带者已经检测到报警状况,由此使得如果已经检测到的该报警状况不是真实的,使用者能够取消该报警(例如通过包含在电子模块12上的按钮开关(开关没有示出))。
同样,可佩带的监测装置的实用的实现指示该装置对于使用者容易应用并且佩带舒适。应用根据本发明的装置的复杂程度不应该比应用胶带复杂很多。在本发明的一个优选的实施例中,电子模块12可以安装在例如电路面积为大约1英寸×2英寸(2.5×5cm)的柔性电路上,或者安装在具有柔性互连的多个刚性电路部件上。
电极14和16靠近电子模块12接附并且该至少两个感测电极14优选为分开2英寸(5cm)或更多。整个组件被粘性的膜20覆盖,粘性的膜20可以为柔性的、防水的、通气的、和/或生物相容的粘性的膜,以帮助将其附着到身体30。提出的系统允许在不妨碍病人的运动和灵活性的情况下精确监测生理状态。以此方式将系统10附着到身体30消除了电极的运动并且因此减小可能由于这样的运动发生的假象。
电极14和16可以为干的导电材料,诸如生物相容的加载碳的聚合物,或导电的粘性水凝胶,诸如用于标准的Ag/AgCl心电学电极的导电材料。本领域中的普通技术人员应该理解,干的电极的优点为干的电极可以为电子模块12的永久的零件,使得全部的装置可以用标准的容许水蒸汽的粘性绷带接附到病人的身体。另一方面,虽然粘性的电极可能需要定制的一次性用品以被接附到电子模块,粘性的电极的优点为在电极和皮肤之间的相对稳定的接触面,并且因此用于分析的心电图信号的噪声更低,并且可以不需要任何附加的粘性元件。
诸如图2所示的本发明的一个实施例,包括全部粘性的电极,使用构成电极的在数个位置施加AgCl粘性凝胶到两侧的优选为通气的布料的一次性的矩形材料条。与双面胶带相似,该一次性的条可以用两个释放衬垫包装。为了施加此类型的可佩带的监测装置,首先移除一个释放衬垫以露出一次性的条的第一粘性侧,并且此第一粘性侧将被施加到电子模块12,对直电极14和16与电子模块12上的Ag导电垫13。随后将移除另一个释放衬垫,即第二释放衬垫,并且将该组件固定到病人的身体。
一旦该装置电子确认足够的信号获取,可以施加粘性的膜20,覆盖整个组件,更稳固地将该组件接附到病人的身体并且还提供保护以不受环境影响,例如提供保护以在沐浴期间不受水的影响。
在图1所示的替代的实施例中,参考电极16可以为干的电极,并且感测电极14为粘性的。在此实施例中,参考电极16可以为电子模块12的永久的零件,定位在电子模块12面向皮肤30的侧上。具有加入胶带20的AgCl粘性凝胶电极区域的定制的胶带20施加到电子模块12的顶部,对直粘性凝胶电极14与电子模块12顶部上的Ag导电垫13。随后将组件10固定到病人身体的表面30。
在再一个替代的实施例中,全部电极,即参考电极16和感测电极14为干的导电聚合物,并且仅粘性的膜20提供接附。
对于粘性凝胶电极,Ag/AgCl化学物质是优选的,即导电垫镀银到电子模块12。导电的聚合物电极也可以以此设计实现,同样作为电子模块12的永久的零件,或在电极的一侧上具有导电的粘合剂以将该电极附着到电子模块12。
虽然在这里特定地示出并且描述了不同的实施例,应该理解,对本发明的修改和变化由上述教示覆盖并且在后附的权利要求书的范围内而没有离开本发明的精神和预定范围。
Claims (9)
1.一种用于检测、处理、分析和报告人体的预先确定的身体情况的可佩带的装置,该装置包括:
多个电极,包括至少一对感测电极(14)和参考电极(16),所述电极中的每个构造为粘附地接附到身体(30)的表面;及
电子模块(12),所述电子模块与所述多个电极中的每个电通信,所述电子模块包括电源,并且所述电子模块处理和分析所述多个电极提供的信号,
其中,所述多个电极和所述电子模块被单一的粘性的膜(20)覆盖,以使得所述可佩带的装置能够附着到身体的表面,
其中,所述电子模块(12)具有顶部表面和底部表面,并且其中多个导电垫形成在该底部表面上。
2.根据权利要求1所述的装置,其中,所述多个导电垫形成在该顶部表面和底部表面上。
3.根据权利要求1或2所述的装置,其中,所述多个导电垫中的至少一个镀银在所述电子模块(12)上。
4.根据权利要求3所述的装置,其中,该对感测电极(14)和参考电极(16)集成到通气的布料母体。
5.根据权利要求4所述的装置,其中,所述通气的布料母体包括在所述布料母体的顶部表面和底部表面上的电极凝胶。
6.根据权利要求4所述的装置,其中,所述参考电极(16)定位在所述通气的布料母体上介于该对感测电极(14)之间。
7.根据权利要求4所述的装置,其中,感测电极(14)分开至少2英寸。
8.根据权利要求1所述的装置,还包括:
无线发送机,并且,当所述电子模块检测到预先确定的状况时,无线发送机发送报警状态;以及
用于向佩带所述装置的人提供指示报警状态被指示的本地报警的器件。
9.根据权利要求8所述的装置,还包括去启动机构,其中,可以操作所述去启动机构以便防止所述装置无线发送报警状态的进一步的指示。
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EP1720446B1 (en) | 2010-07-14 |
EP1720446A1 (en) | 2006-11-15 |
JP2007525269A (ja) | 2007-09-06 |
ATE473678T1 (de) | 2010-07-15 |
DE602005022282D1 (de) | 2010-08-26 |
CN1921798A (zh) | 2007-02-28 |
JP4921349B2 (ja) | 2012-04-25 |
US7904133B2 (en) | 2011-03-08 |
WO2005084533A1 (en) | 2005-09-15 |
US20080214901A1 (en) | 2008-09-04 |
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