CN101534706A - 具有一次性电极模块的身体佩带的生理学传感器装置 - Google Patents
具有一次性电极模块的身体佩带的生理学传感器装置 Download PDFInfo
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Abstract
一种身体佩带的病人监视装置包含至少一个一次性模块,其包含到身体的多个电连接。所述身体佩带的病人监视装置还包含至少一个通信-计算模块,所述通信-计算模块具有至少一个微处理器以有效监视病人并执行对生理学信号的实时生理学分析。无线电电路在预定时间或在预定事件发生时经由到远程无线电接收器的无线电传输来传送原始生理学信号或所述生理学分析的结果,其中所述至少一个一次性模块以机械和电方式直接耦合到所述至少一个通信-计算模块。所述身体佩带的病人监视装置,包含所述至少一个一次性模块和所述至少一个通信-计算模块在内,直接非永久性地固定到所述病人的皮肤表面。
Description
技术领域
本发明大体涉及一种生理学监视器,且更明确地说涉及一种身体佩带的生理学监视器。
背景技术
各种生理学参数的测量对于研究人体状况很重要。生理学测量在例如医院中的健康护理机构中可能尤其重要。对病人执行的较重要生理学测量之一是心电图(ECG),其展示人类心脏的状况。
便携式病人监视器已发展为允许病人至少享受一些可动性。通常,电池操作的监视器可悬挂在腰带、背带上,或由病人使用某一其它类似悬挂布置而携带。例如ECG电极的传感器例如用带子固定到病人的身体,且通过电线连接到电池操作的监视器。在固定的时间间隔之后,或在低电量指示下,可替换电池或对电池进行再充电。便携式病人监视器的一个实例是Micropaq无线病人监视器,其由美国伟伦公司(Welch Allyn,Inc.)制造,且准许在小型、坚固、重量轻的病人可佩带装置中建立多参数监视和病人警报能力。
便携式生理学监视器的另一版本为通常由参与运动员活动的个体使用的心率监视器。监视器包含传感器,其通常与个体的胸腔直接或间接接触以监视心跳,且接着传感器通过电线或通过无线技术将所感测的心跳传输到附近的基于微计算机的监视器和显示器。此类单元通常仅测量心跳且不能进行传统ECG分析功能的任一者。
通常用于健康护理应用中的便携式监视器反复出现的问题是需要从位于病人身体上的传感器到便携式单元的电线。这些电线可能缠结并导致不适,或当因不注意而拉动或拖动时被拔去插头。另外,电线运动可能归因于摩擦电效应而增加ECG噪音。肌肉运动也可能归因于主要肌肉上ECG电极的典型放置而增加ECG噪音。此外,便携式监视器电池维护(例如,电池再充电或替换)可能耗费时间且较昂贵。
另一问题是关于医用监视器经受住至少360焦耳的多个除纤颤循环的要求。常规上,与固定或便携式生理学监视器的引线串联定位的一个或一个以上功率电阻器已满足此要求。问题是,常规功率电阻器的物理体积太大而不能用于紧凑型监视器应用中。
小型传感器装置的另一缺点是,这些装置缺乏依据病人状况改变所传输数据的量和类型的智能。训练心脏监视器不传输完全病人波形用于临床分析,而医用监视器测量并传输完全病人波形,即使当病人健康时也如此。虽然传输完全病人波形从纯临床观点来看是优选解决方案,但此传输需要显著功率来传输大量数据且将设计限制为小型且便宜的。
又一问题是,心律失常分析是不完全适于当前不能执行心律失常分析的现有小型便携式监视器的计算密集型操作。
因此,需要一种身体佩带的组合型生理学传感器和监视器,其具有一次性传感器,但由病人直接作为单一单元使用和佩带且非永久固定到病人的身体。并且,需要一种物理上紧凑型电阻性元件,用于保护身体佩带的装置免遭多个除纤颤循环引起的损坏。并且,需要一种医用监视器,其可智能地仅视需要测量并传输数据以警告临床医师病人需要额外护理。还需要一种能够通过计算有效型算法运行心律失常分析的身体佩带的装置。
发明内容
根据一个方面,一种身体佩带的病人监视装置包括至少一个一次性模块,所述一次性模块包含到身体的多个电连接。电连接耦合到病人的皮肤表面以测量病人的生理学信号。所述至少一个一次性模块包含一次性模块连接器。身体佩带的病人监视装置包含至少一个内部或外部电源以对身体佩带的病人监视装置供电。身体佩带的病人监视装置还包含至少一个通信-计算模块,其具有通信-计算模块连接器以经由所述一次性模块连接器从所述至少一个一次性模块接收生理学信号。通信-计算模块还包含:至少一个微处理器,用以有效监视病人并执行对生理学信号的实时生理学分析;以及无线电电路,用以在预定时间或在预定事件发生时经由到远程无线电接收器的无线电传输而传送原始生理学信号或所述生理学分析的结果,其中所述至少一个一次性模块以机械和电方式直接耦合到所述至少一个通信-计算模块。所述身体佩带的病人监视装置,包含所述至少一个一次性模块和所述至少一个通信-计算模块,直接非永久固定到病人的皮肤表面。
根据另一方面,一种为身体佩带的监视器提供高电压电路保护的方法包括以下步骤:提供支撑到病人身体的一个或一个以上电连接的衬底;确定待印刷于衬底上的具有第一电阻率的第一材料的印刷图案和厚度;确定待印刷于衬底上的具有第二电阻率的第二材料的印刷图案和厚度;将第一材料印刷到衬底上;以及将第二材料印刷到衬底上,其中第二材料的至少一部分覆盖第一材料。
附图说明
为了进一步理解本发明的这些和目的,将参看以下具体实施方式,将结合附图阅读所述具体实施方式,附图中:
图1A展示具有一次性电极模块的示范性身体佩带的生理学监视器;
图1B展示图1A的身体佩带的生理学监视器的局部未组装侧视图;
图1C展示图1A的身体佩带的生理学监视器的经组装侧视图;
图1D展示图1A的身体佩带的生理学监视器的仰视图;
图2展示示范性身体佩带的生理学监视器的分解透视图;
图3展示示范性计算和通信模块的分解透视图;
图4A展示示范性一次性单元柔性电路板;
图4B展示图4A的柔性电路板的一部分的局部放大视图,其进一步展示具有圆角的示范性电阻性迹线;
图4C展示图4A的柔性电路板的一部分的局部立面侧视图,其进一步展示覆盖电阻性材料的示范性传导表面;
图4D展示图4A的电路板的局部立面侧视图,其进一步展示具有按扣插孔的示范性传导表面;
图5展示具有在一次性单元中的电源的身体佩带的生理学监视器的一个实施例的框图;
图6展示具有在计算和通信模块中或连接到计算和通信模块的电源的身体佩带的生理学监视器的一个实施例的框图;
图7A展示结合身体佩带的生理学监视器使用的直接连接的参考电极的示意图;
图7B展示结合身体佩带的生理学监视器使用的虚拟参考电极的示意图;
图8展示描绘提供在身体佩带的生理学监视器上以选择参考电极配置的模拟切换布置的一个实施例的示意图;
图8A展示与身体佩带的生理学监视器的电极一起使用的示范性经驱动引线电路拓扑;
图9展示具有电路保护的示范性ESIS滤波器电路拓扑;
图10展示图9中描绘的电路保护的替代性电路保护;
图11展示由身体佩带的生理学监视器利用以检测病人是否具有起博器的算法的流程图;
图12展示可用于基线恢复的高通滤波器的电路拓扑;
图13展示所绘示振幅对频率的七幅曲线图以说明图12的电路的示范性操作;
图14展示身体佩带的ECG监视器将直接非永久固定到病人身体的两个示范性位置;
图15展示用于在电阻性迹线上模拟病人除纤颤的效果的设置的框图;
图16A象征性展示托盘上加网印刷的电阻性圆点丝;
图16B展示经烘烤电阻性圆点的示范性电阻性分布的柱状图;以及
图17展示示范性ECG波形。
各图式之间封装式样稍有不同。此微小差异,例如计算和通信模块102的外壳式样,说明适宜用作身体佩带的监视器的机械封装的微小变化。图式不一定按比例展示。
具体实施方式
本文关于某些示范性实施例描述“身体佩带”的装置。本文中将“身体佩带”的装置界定为直接且非永久固定到病人身体的装置。“身体佩带的监视器”是可作为单一单元直接“佩带”在病人身体上的装置,包含一个或一个以上生理学传感器和一通信和计算模块以至少执行使用一个或一个以上生理学传感器进行的一个或一个以上生理学测量的初始处理。不同于现有技术病人可佩带的装置,至少一个传感器可并入到所述装置中,其与病人身体形成直接或间接(例如,通过电容性耦合)电连接而不使用从传感器到装置的外部电线。另外且不同于运动员心脏监视器,“身体佩带”的监视器可以是全功能医用监视器,例如满足欧洲联盟的医用装置指示和其它适用的工业标准(例如,针对心电图仪的EC-13)的要求。身体佩带的医用监视器可包含一装置,例如脉冲血氧计、CO2监视器、呼吸监视器,或可充当ECG监视器,其并入有生理学传感器、前端模拟电子信号调节电路,和具有所测量生理学数据的无线报告的基于微计算机的计算单元,其均包含在可非永久地直接固定到病人身体的“身体佩带”的封装内。身体佩带的医用监视器还可包含超过此处提及的那些测量能力的额外测量能力。
图1A-1D描绘具有通信和计算模块102以及一次性电极模块110的示范性身体佩带的生理学监视器100的各个图式。在此示范性实施例中,生理学监视器100经设计以用作心电图(ECG)监视器,其用于获得并记录和/或传输ECG信息,包含ECG波形和对佩带身体佩带的生理学监视器100的人(例如,病人)的警报。
图1A展示身体佩带的生理学监视器100的示范性俯视图。月牙形状允许将身体佩带的生理学监视器100放置在病人的胸腔上,且更明确地说放置在大胸肌周围,以允许将引线配置I、II或III的测量,或放置于病人的侧面,从而允许使用V引线配置进行测量。尽管未展示,但可使用多个身体佩带的生理学监视器100单元来有效提供多个引线。通过将电极放置在身体周围使得其不直接定位在主要肌肉顶部,可防止运动噪音伪影和肌肉噪音伪影两者。此外,通过排除电缆,归因于电缆运动或压缩(即,摩擦电效应)的噪音可排除。
图1B展示具有示范性附接机构(例如,保持夹具104)以将通信和计算模块102机械附接到一次性电极模块110的顶部表面的生理学监视器100的立面侧视图。柔性印刷电路层101可由薄绝缘材料制成,例如根据此实施例,75微米厚的Mylar层。通常,柔性印刷电路层101上的电迹线(图1A-1D中未展示)可由类似于保形涂层的绝缘覆盖层进一步保护。一侧上具有粘合剂的经成形塑料层或布可用于覆盖并保护柔性印刷电路层101,并且提供美学外层以使身体佩带的监视器100视觉上讨人喜欢。
图1C展示其中通信和计算模块102已固定到一次性电极模块110的生理学监视器100的侧视图。图1D描绘示范性生理学监视器100的下侧的视图,其展示具有电极109的一次性电极模块110的一个实施例。在此实施例中,每一电极109包括电极凝胶103和传导表面404(图4)。电极凝胶103和传导表面404一起形成半电池(half-cell),例如银/氯化银半电池。并且,且根据此实施例,传导表面404可直接接受电极凝胶103。
图2展示示范性身体佩带的生理学监视器100的分解组装图。如关于图1A-1D注意到,身体佩带的生理学监视器100包含可移除且可再使用的通信和计算模块102以及一次性电极模块110,后者包含用于ECG监视的电极凝胶103和用以对通信和计算模块102供电的电池204。平坦平面绝缘/粘性部件105包含多个开口,其每一者经设计大小以接纳电极凝胶103。绝缘部件105为柔性印刷电路层101提供底侧封盖,且增加到人体的粘合。电极凝胶103当附接到例如银-氯化银或其它衬底等适当的衬底时,可用于在传导表面404(图4)与病人皮肤之间建立相对低阻抗电连接。
电极凝胶103可粘合到病人的皮肤。虽然电极凝胶103通常是粘性电极凝胶,但单单电极凝胶103所提供的粘合可能不能为将身体佩带的生理学监视器100非永久固定到病人提供足够固持力。为了实现身体佩带的监视器100到病人皮肤的较好粘合,可使用绝缘/粘性部件105将身体佩带的生理学监视器100非永久固定到病人。因此,身体佩带的监视器100可以与施加粘性带(例如,在商标名“BAND-AID”下出售的那些粘性带)相同的方式施加到病人。一种适于将柔性电路板固定到病人的示范性类型的泡沫粘合剂是来自英国贝德福德郡(Bedfordshire,UK)的斯卡帕医疗公司(Scapa Medical)的1.6mm粘合剂泡沫。如图1B和1C所示(尽管未按比例绘制),电极凝胶103的每一者在粘合剂层105下方充分延伸以便确保与病人皮肤表面(未图示)的良好电连接。舌片106(图1A)允许从粘合剂层105容易地移除保护性背衬111。
柔性印刷电路层101可包含接触件(例如,电池夹具(未图示))以接纳并连接到电池204。(预期在某些将来的实施例中,单一电池可提供足够的电功率。)在示范性实施例中,如图2所示,电池204可安装在布置于柔性印刷电路层101的相对侧上的相应电池襟翼(battery flap)205下方。或者,电池夹具(未图示)或电池固持器(未图示)可用于为电池204的每一者提供机械支撑和电连接两者。适于此用途的一种类型的电池固持器(例如)是由纽约阿斯托里亚(Astoria,NY)的吉斯通电子公司(KeystoneElectronics Corp.)制造的型号2990电池固持器。电池封盖107为电池204提供保护,并且提供一表面以在将电极103施加到传导表面404时在上面进行按压。保持夹具104可包括(例如)多个具有闭锁夹具的弹簧指形物。固定到一次性电极模块110的保持夹具104可用于将可再使用的通信和计算模块102固定到一次性封装110。本文以简化的表示说明可再使用的通信和计算模块102,包含封盖201、通信和计算印刷电路板组合件202以及底座203。
图3展示示范性可再使用的通信和计算模块102的机械视图,以及在一次性电模块110中的柔性印刷电路层101与位于可再使用的通信和计算模块102中的通信和计算印刷电路板组合件202之间形成电连接的优选方法。在此示范性实施例中,通信和计算印刷电路板组合件202可包含用于接纳电插塞302的多个按压配合和/或经焊接传导插口301,所述插塞具有相应多个传导引脚。插塞302中所示的每一传导引脚可对应于柔性印刷电路层101上的电连接。一行机械插口303可接纳插塞302的多引脚行。因此,可在具有插塞302上的传导支柱的柔性印刷电路层101的每一衬垫与通信和计算印刷电路板组合件202上的每一相应传导插口301之间形成电连接。支柱304可对准并固定封盖201、通信和计算印刷电路板组合件202以及底座203的每一者。注意在图3中,封盖201的简化视图省略了用以接纳保持夹具104以将通信和计算模块102固定到一次性封装110的槽。身体佩带的监视器100通常还将包含保持夹具104(图2),或其它适宜类型的机械夹具,以便在通信和计算模块102与一次性电极模块110之间提供牢固的机械连接。
图4A在分解(例如,未组装)图中展示柔性电路板101的一个实施例。柔性电路板101形成于衬底406上。衬底406可(例如)从具有适宜厚度的聚酯薄膜薄片(Mylarsheet)切割。在此实施例中,一个电池204可邻近于传导表面404而安装。传导凝胶103(图4中未展示)可安装在传导表面404的暴露的传导侧上。
传导表面404也可视为半电池的电极部分,且电极凝胶103可视为半电池的电解质部分。在常规技术术语中,电极和电解质与ECG电极的组合通常称为半电池。举例而言,传导表面404与电解质层(例如,电极凝胶103)的组合形成半电池。为了便于快速参考半电池结构,本文中将术语“电极”(指派有参考标号“109”)与“半电池”可互换使用。应了解,在典型实施例中,电极109包括传导表面404和传导凝胶103。
通常,电极利用圆形或正方形传导表面。增加表面的周长与表面的面积的比率影响电流密度分布和除纤颤恢复。
为了方便起见,我们在本文中始终将术语“环带”定义为两条简单曲线之间的区。简单曲线是不与其本身交叉的闭合曲线。在此定义下,环带可包含大体正方形形状、大体矩形形状、大体圆形形状、大体椭圆形形状,以及具有圆形隅角的大体矩形形状。此外,我们在环带的定义中包含如单一闭合曲线所描述的大体“U”形表面的情况。
身体佩带的监视器上适于此用途的一种示范性电极凝胶103是捷克斯洛伐克共和国的布拉格(Prague,Czech Republic)的泰科健康护理(Tyco Healthcare)供应的型号LT00063水凝胶。通常,传导表面404形成半电池的电极部分。通过增加半电池的圆形电极部分的周长与面积的比率,可增加输入ECG信号的信噪比。
如本文在示范性电路布局上所描绘,两个电池304可串联连接,其中使一个极性在来自电池连接402的连接垫407处可用,电池连接401在两个电池之间形成串联连接,且连接垫410提供串联连接的电池的第二极性。注意在一些实施例中,或者可使用单一电池代替示范性实施例,或两个电池也可用电线并联连接,此取决于特定通信和计算模块102的电压要求。
连接垫408和409经由传导表面404和电阻性迹线412将来自电极凝胶103(图4A-4D中未展示)的信号电耦合到电插塞302(图4A-4D中未展示)。电极接触垫405可经由电阻性迹线413连接到连接垫411以提供直接连接的参考电极(图4A-4D中未展示)。在传导表面404与连接垫408和409之间延伸的迹线412以及在传导表面405与连接垫411之间延伸的迹线413可由包含电阻性金属、碳、银墨、粉末、涂料或可测定电阻的其它材料的电阻性材料制成。
柔性电路板层101上的电阻性迹线代替现有技术监视器需要的体积庞大的功率电阻器(其具有通过电线或引线连接的电极或传感器)。这些电阻性迹线应经受住多个除纤颤循环使得身体佩带的监视器100即使在一次或一次以上试图重新起动病人的心脏之后也保持起作用。为了经受住除纤颤,电阻性迹线应消耗潜在破坏性除纤颤能量的耦合到监视器的部分。除纤颤能量的此分数部分通常从电极109(图1D)(电极109包含传导表面404和电极凝胶103)进入身体佩带的监视器100。
需要保护性电阻性迹线的电阻在约1千欧姆到约10千欧姆的范围内。在1千欧姆以下,依据所使用的电阻性材料,可能较有可能电阻性迹线412和413的电阻将随着每一连续除纤颤脉冲而增加。在10千欧姆以上,高电阻削弱信噪比,尤其归因于热噪音,其具有4*k*T*R*BW的均方值,其中“k”是玻尔兹曼常数,“T”是以开氏温标度数测量的温度,“R”是以欧姆计的电阻,且“BW”是以Hz计的带宽,其相对于经参考应输入的噪音小于30μV峰谷比的EC-13要求而变得显著。
本文描述的迹线中的功率消耗可通过E2/R计算,其中E是指跨越迹线的电位,且R是迹线的电阻。R可通过ρ*L/A计算,其中ρ是用于形成迹线的材料的电阻率,L是迹线的长度,且A是迹线的横截面面积。
在开发用于柔性印刷电路层101(通常形成于聚酯薄膜衬底406上,例如图4A所示)上的电阻性迹线时,测试各种材料。银(包含银墨)虽然可用,但发现其不太符合需要,因为难以实现聚酯薄膜上足够薄的银迹线以实现足够高的电阻。也已尝试碳(包含碳膏和碳墨)且发现其是适宜的。然而,为了使用碳,必须解决若干额外问题。在1千欧姆处,电阻器消耗的功率致使其跨越多个除纤颤循环而降级。解决方案是使碳迹线在约8到10千欧姆的范围内。10千欧姆电阻证明是噪音电平、电阻器的功率消耗与用于在聚酯薄膜衬底上沉积碳墨以消耗来自多个除纤颤循环的功率的制造容限之间的良好折衷。为了实现约10千欧姆的所需电阻(木文可互换地表示为“10k”或“10kΩ”),对于碳膏的给定电阻率以及给定的迹线宽度和厚度(高度),接着界定迹线的长度。在一些情况下,例如对于迹线412,如传导表面404与连接点409之间的迹线行程所需的长度可能长于针对特定迹线电阻(通常为10k)界定的长度。在此情况下,迹线可延伸银传导迹线的长度。可存在大约5到10mm的短覆盖距离,其中银迹线与碳迹线重叠以在迹线的电阻性部分与传导部分之间提供较稳健连接。在使用重叠的情况下,可稍许调节电阻性部分的总长度以维持所需总电阻。
与碳迹线相关联的另一问题是碳迹线与传导迹线之间的界面处的起弧(arcing)。起弧在碳迹线与传导表面404之间的急剧连接处尤其有问题。经观察,起弧在碳迹线的端截面与传导表面404之间发生。(电极凝胶103形成穿过传导表面404和传导凝胶层到病人的传导路径)。
根据上述起弧问题的一个解决方案,如图4B所示,可在与传导表面404的界面处添加碳迹线的圆形(圆角)截面430。圆角或“泪滴”形状致使碳迹线随着其连接到传导表面404并缓解界面处的电位应力而逐渐变宽。
起弧问题的一替代解决方案在图4C中展示,其中碳可铺设超过迹线(412)以包含由碳形成的传导表面404的图案。可在沉积传导表面404之前沉积碳环带图案。接着可在早期形成的碳环带形状上沉积传导表面404作为覆盖层。最后,传导凝胶103可附接到传导表面层(碳层驻留在传导表面404与用作柔性电路板101的聚酯薄膜衬底之间)。先前提及的两个起弧解决方案可一起使用。还应注意,传导表面404可由不同于银的适宜材料形成,包含(例如)诸如氯化银的材料。
起弧也可在柔性电路板101上的电阻性迹线与其它(通常银)传导迹线之间发生。可通过允许迹线之间的充分间隔来抑制迹线到迹线的起弧。一般来说,已发现如ASNI/AAMI DF80:003 57.10 BB要求的约3mm/kV的最小间隔足以防止由于除纤颤事件而引起迹线到迹线的起弧。可通过首先在柔性电路板101的表面上施加覆盖大部分衬底和迹线的类似于保形涂层的绝缘介电层来成功地采用紧密达0.01mm/kV的较紧密迹线间隔。可例如通过在施加绝缘层期间使用掩模来防止绝缘介电层形成或粘合到传导表面404。
在替代实施例中,如图4D中所描绘,可将按扣装置(snap device)添加到传导表面404以接受制造搭锁(snap-on)电极(未图示),例如包含由纽约尤蒂卡(Utica,NY)的康美公司制造的型号1700透明迹线电极的ECG电极的康美透明迹线,或由明尼苏达州圣保罗(St.Paul,MN)的3M公司制造的类似类型的电极。当经设计以接受搭锁电极时,传导表面404通常比在先前实施例中小。用于接纳商业搭锁电极的插孔按扣432可通过任何适宜的方法(例如通过按压配合或其它紧固方法)插入到传导表面404中(通常还穿透衬底406)。在此实施例中,可在此实施例中通过将圆角添加到碳-传导表面界面和/或在碳层上沉积传导表面404(如先前所描述)而类似地抑制起弧。
实例:在由CT3热稳定处理的聚酯(75微米厚)(例如,由伊利诺斯州绍姆堡的麦德美—欧图钛公司制造)形成的衬底上测试电阻性迹线和环带。使用来自特拉华州威尔明顿的杜邦公司的7102碳膏导体将电阻性迹线丝加网印刷到衬底上。碳膏导体沉积穿过43T丝网筛网。含有膏沉积物的衬底接着在120℃下在风扇辅助的空气循环烤箱内部固化持续5分钟的周期。所形成的迹线约55mm长且2mm宽,具有约7.5微米的总厚度。每一迹线的初始所测量电阻约14千欧姆。在每一迹线经受3个除纤颤循环之后,所测量电阻增加到约15千欧姆。在3mm长度上,迹线加宽到约5mm,从而终止于具有外径约20mm且内径约10mm的碳环带中。来自英国东莱汉普郡的诺固公司的PF-410银墨的银层接着沉积在碳环带上,同样到约7.5微米的总厚度。银层的沉积是经由网版印刷方法,其中使用90T丝网筛网。含有所沉积银墨的衬底接着在120℃下在风扇辅助的空气循环烤箱内部固化持续15分钟的周期。包括SD2460,成分A & B(电介质和硬化剂)(由德国肯潘(Kempen,Germany)的彼德仕股份有限公司(Lackwerke Peters GmbH+Co KG)制造)且具有近似13微米厚度的第三介电绝缘层接着沉积在迹线和衬底上,而不沉积在环带上。(通过将传导凝胶附接到环带而形成电极。所使用的传导凝胶是来自捷克斯洛伐克共和国的布拉格的泰科健康护理的LT00063水凝胶。)再次,使用网版印刷工艺穿过90T筛网沉积介电层。再次在120℃下将衬底放置到风扇辅助的空气循环烤箱中持续30分钟的周期。
实例:身体佩带的监视器电路衬底上用作传导(非电阻性)迹线的银迹线是通过丝网版印到聚酯薄膜衬底上的银膏形成。45mm长迹线具有在3.5到6欧姆范围内的测量电阻,75mm迹线具有在6.5到13欧姆范围内的测量电阻,且105mm迹线具有在10到16欧姆范围内的测量电阻。银层的沉积是经由网版印刷方法执行,其中使用90T丝网筛网。含有所沉积银墨的衬底接着在120℃下在风扇辅助的空气循环烤箱内部固化持续15分钟的周期。
图15以图表描绘用于在电阻性迹线上模拟病人除纤颤的效果的示范性测试设置。使用除纤颤器1501将360焦耳的多个除纤颤冲击每一者施加到100欧姆电阻器1502。根据此设置的100欧姆电阻器模拟病人的身体。注意,除纤颤能量的大部分通过设计进入病人的身体,以重新启动病人的心脏。电阻性迹线1503和1504跨越电阻器1502以电线连接,同样如图15所示,以便模拟将形成在位于正经历除纤颤的病人身上的身体佩带的监视器中的电阻性迹线之间的电路。使用氖灯泡1506作为可与身体佩带的监视器中的电阻性迹线一起使用的保护电路的一部分。存在400欧姆安全电阻器1505作为预防措施以限制测试设置失败的情况下的短路电流。根据医疗规范AAMI EC-13使用100欧姆电阻器(模拟人类皮肤电阻)和400欧姆安全电阻器两者。在每一者360焦耳的3个除纤颤冲击之后,10k碳迹的所测量电阻在第一冲击之后从10k变化到11k,在第二冲击之后变化到13.1k,且在第三冲击之后变化到13.2k。9.7k迹线的所测量电阻在第一冲击之后从9.7k变化到11.6k,在第二冲击之后变化到13.0k,且最后在第三冲击之后变化到13.2k。在后续相关测试中,100欧姆电阻器由新鲜(死的)小鸡形式的较接近模拟替代。设置以其它方式保持与图15所示相同。在此情况下,测试电阻性迹线的每一者上测量的电阻在多个除纤颤之后从10.7k变化到10.25k,且从8.5k变化到9.4k。在测试期间,还注意到,电阻性迹线的所测量电阻的变化大体是恒定的。还注意到,随着给定电阻性迹线增加,(ΔR{由除纤颤引起}/R{净迹线电阻})可最小化。
通过使用由网版印刷机(未图示)施加的7102碳墨印刷多个约20mm直径的小碳电阻性点1601来进一步研究用于铺设电阻性迹线的网版印刷技术。碳点1601排布在托盘1602上,如图16A所示,用于在烤箱中烘焙。使用手动操作的橡皮辊(未图示)通过掩模(未图示)将电阻性点1601施加到托盘1602。可确定施加期间厚度的控制是控制电阻分布的一个重要因素。注意到,在手动施加期间,电阻的变化取决于多个点1601与施加电阻膏的人之间的距离,且使用橡皮辊施加的压力也可以因数2影响最终电阻。进一步注意到,托盘1602上的“均匀”加热在烤箱干燥期间是有利的,但发现此因素对最终点电阻分布具有较小影响。经烘焙和测量的点1601的电阻分布展示于图16B的柱状图中。此测试指示铺设在衬底(例如,聚酯薄膜)上以在身体佩带的监视器中使用的生产迹线应优选地使用半自动网版印刷工艺来印刷,例如通过网版印刷机械辊工艺。使用具有放置在点1601的每一边缘处的探针的数字万用表(“DMM”)来测量从点的一个边缘到另一边缘的电阻。发现墨的均匀施加对于保持紧密的电阻分布很重要,其中均匀加热对测试点的电阻分布具有较小影响。由于具有过小电阻的迹线具有较大ΔR/R,且较高失败机率和非常高的电阻迹线导致较差的S/N比率,所以重要的是具有对迹线电阻的合理紧密容限。
图5展示代表身体佩带的生理学监视器100的一个实施例的框图。生理学传感器501(例如,图1D中的电极109)可电耦合到机电连接器502(如通过图4所示的电阻性迹线412)。连接器502用以将通信和计算模块102电耦合到一次性电极模块110(图2)。次级连接器503也可将一个或一个以上额外传感器(其可位于一次性电极模块110之上和之外)电耦合到机电连接器502,用于连同生理学传感器信号501一起经由机电连接器505电耦合到通信和计算模块102(图1所示)。由通信和计算模块102接收的信号可经由电子保护电路506和/或滤波器(例如,ESIS滤波器507)电耦合到通信和计算模块102中。
信号可由保护电路506视需要限制或限幅,或由滤波器507滤波。可使用一个或一个以上模拟放大器508来放大振幅经限制和经滤波的信号。在示范性身体佩带的ECG监视器中,放大器508可有利地为差动放大器以放大两个ECG电极之间的差信号(例如,ECG“向量”)。放大器508的电输出可电耦合到调搏器(PACER)电路509和ECG电路510两者。调搏器电路509在下文进一步描述。ECG电路510执行若干功能,包含“迹线恢复”、低通滤波(抗混叠)、高通滤波和放大(增益)。低通滤波滤波器根据尼奎斯特准则信令,以避免稍后当信号由模拟到数字转换器(ADC)516数字化时的混叠。高通滤波器致使输入从约0.05Hz的滑离频率AC耦合,如工业ECG标准所规定。需要增益以致使来自生理学传感器(例如,电极109)的小的预先放大电位与数字化ADC 516的可用动态范围较紧密地匹配。注意,ADC 516可以是专门的ADC芯片,或可包含在微计算机集成电路(例如,充当微处理器512的微计算机)中。
微处理器(例如,微处理器512)在本文中定义为与术语“微计算机”、“微控制器”和“微处理器”同义且可互换。此类微处理器在本文中还可互换地表示为“μP”或“μC”。此外,本文揭示的任何微处理器可由可执行微处理器的功能的任何集成装置代替,例如(但不限于)经编程以执行微处理器的功能的现场可编程门阵列(“FPGA”)。
通常,一个或一个以上差动放大器可专用于与生理学传感器501或504相关联的特定差电压,但应注意,一个或一个以上放大器508也可通过此项技术中已知的技术经多路复用,以使用较少数目的放大器服务于多个生理学传感器。类似地,一个或一个以上ADC 516可使用例如在在将数字结果逐一发送到下一级的时间数字化一个生理学传感器差信号时多路复用的技术服务于来自生理学传感器501或504的两个或两个以上信号。ECG电路510和调搏器电路509以复数形式参考,因为针对每一所测量生理学信号(例如,针对每一所测量ECG向量)可存在个别电路。
来自电源515的电功率可由调整器514调整并作为经调整电压517分配到大多数功能块(如本文中由标号“电源(POWER)”表示)。这些功能块的每一者还具有来自微处理器512的控制(“CTRL”)输入511,从而允许在不需要时停用这些电路以便节省电池功率。当随时间观察时,大多数ECG波形不含有有用信息,因为心跳之间存在显著“停歇时间”。因此,举例来说,从一个心跳结束时的“T形波”结束到下一心跳开始时的“P形波”开始,可将电路断电(在装置“休眠模式”中)以节省电源中存储的否则将已在此停歇时间期间被使用的能量的大约60%。
图17展示示范性ECG波形。简要来说,P形波可与导致心房收缩的电流相关。QRS复合波可与左心室和右心室的心室收缩相关。Q形波可与行进穿过室隔膜的电流相关,而R形波和S形波可与心室收缩相关。T形波归因于心室的再极化。通常,心房再极化在QRS复合波顶部发生,且远小于QRS复合波,并不可见。ST段将QRS复合波连接到T形波。不规则或缺失波可以是心脏问题的指示符,所述心脏问题包含:局部缺血组织,例如归因于心肌梗塞、束支阻滞、心房问题(尤其是P形波异常)、心包炎和电解质紊乱。
一般来说,电源515可包含通常设置在一次性电极模块110上的一个或一个以上“按钮”单元;然而,图6的框图展示身体佩带的生理学监视器100的实施例,其中功率由位于通信和计算模块102上或连接到通信和计算模块102而不是驻留在一次性电极模块110内的电源供应。
除了功率节省考虑,在身体佩带的生理学监视器100的一些实施例中可能还需要在ADC转换循环期间将微控制器和/或其它电路(尤其包含数字电路)置于休眠模式中,以使自身产生的电噪音的拾取最小化并使功率使用最小化。优选地,A/D电路可在唤醒微处理器之前获取多个样本并缓冲所述样本,微处理器接着可批量处理数据。缓冲可经设定以与病人的心率匹配,因为在获得样本时分析每个样本并无显著临床益处。
回到输入电路,通常放大器508是可用于选择性地放大连接器端子(例如,ECG向量)之间的所需差信号且同时拒绝共模信号(例如,在两个连接器端子上同时出现的干扰信号)的差动或仪器用放大器。除了使用差动放大器,还可有利地使用其它技术来进一步减少共模拾取(CMR)且因此改进身体佩带的生理学监视器100的输入放大器级的共模抑制比(CMRR)。CMR对于身体佩带的生理学监视器100尤其受到关注,这是因为潜在干扰电磁场(例如,贯穿于医院的50Hz或60Hz AC功率线分布)的扩散。举例来说,许多荧光吊灯器具产生强60Hz交流电(AC)电磁场,其可作为共模信号在生理学传感器501(例如,ECG电极109)上出现。
图7A展示其中包括多个ECG电极109和701的身体佩带的生理学传感器501的一个实施例。两个电极109对病人703产生ECG差电位。第三电极(参考电极701)可电耦合到电子元件共点704(或其它电位电平)且可用于改进CMR。在此实施例中,电子元件共点704(图7A中展示为电池的负端子)可直接在电极109附近连接到病人。因此,可使通信和计算模块102中的电子电路的电子元件共点更紧密地遵循电极109附近的电位的任何变化。参考电极701可尤其有助于确保输入109保持在合理窄的共模范围内,例如通过减小否则将出现以在60Hz下相对于电极109移动电子元件共点704的60Hz电位。
在图7B所示的另一实施例中,虚拟电极702执行如先前关于参考电极701所描述的类似功能。在此实施例中,代替于创建DC耦合的参考电极,电极701由柔性印刷电路层101与病人703之间的电容性耦合代替,从而形成具有AC耦合的共点的虚拟电极702。此AC耦合随着柔性印刷电路层101与病人之间的距离减小而增加,且可有利地减少60Hz共模信号(AC信号)。
在直接连接的电极701的又一版本中,如图8A所示,电极701可由来自通信和计算模块102的电输出有源地驱动。通常,可使用运算放大器(OpAmp)或其它类型的放大器来创建“经驱动引线”。经驱动引线电路可用于进一步改进如图7A所示的无源电极701上的CMR。适用于驱动电极701的示范性电路展示于图8A中。放大器(OpAmp)810和811缓冲来自电极1和2(示范性电极109)的高阻抗信号。差动放大器508传递如先前描述的差信号(例如,ECG向量)。两个10千欧姆电阻器提供在缓冲放大器810和811的输入处同时出现的共模信号的平均值。建立在OpAmp 812周围的逆转低通滤波器逆转经平均的共模拾取信号(电极1和2处)且将所述信号异相地(180度相移)施加到直接连接的经驱动电极(例如,电极701)。通过将平均共模信号施加到经驱动电极,放大器812通过有效噪音取消有效地将电极1和2处的共模信号抑制在负反馈回路的有效带宽内。理论上,可类似地驱动虚拟电极702,但用以驱动电容性耦合的共同电极的电压要求足够高而使得“经驱动虚拟电极”成为不太可行的选择。因此,可看出,参考电极可以是无源连接或有源驱动连接。
可能还需要有一种以上CMR技术可用。举例来说,在低噪音环境中,较低功率参考电极可能用于CMR。因而,如果噪音增加到参考电极提供不充足CMR的电平,那么身体佩带的监视器可切换到较适于高噪音环境中的CMR的经驱动引线。在此实施例中,可通过电子切换选择特定CMR配置。图8展示表示为参考电极开关801的一个此类示范性切换块。微处理器(μP)512可控制参考电极开关801以选择直接连接的电极701、虚拟电极702,或由经驱动引线电路802额外驱动的直接连接的电极701。还应注意,在图8的实施例中,当虚拟电极702提供充足CMR时,电极701可用作第三电极,因此允许身体佩带的监视器100同时测量两个不同心脏向量。
图9展示示范性除纤颤保护电路(506)和ESIS滤波器507的一个实施例。如图9所示,电极109可经由输入电阻器R91和R92连接。气体放电管(例如,氖灯泡L1和L2)可通过在经设计电压下启动以防止到放大器508的输入引线处出现较大电位而用于过电压保护。气体放电管可设置在一次性电极模块110上或通信和计算模块102上。除纤颤保护电阻器R91和R92可进一步例如以迹线412的电阻的形式驻留在一次性电极模块110中。
ESIS滤波器507可用于满足关于电外科干扰抑制(ESIS)的AAMI标准EC13。标准EC13说明ECG监视器在连接到身上正使用电外科装置的病人时以令人满意的方式显示和处理ECG信号的能力。在没有此抑制的情况下,电外科装置的高RF输出可致使ECG监视不能实现且/或致使监视器无用。电阻器R93到R98以及电容器C91到C96形成级联低通滤波器区段(例如,R93-C1)。三个级联单极滤波器展示于放大器508的每一输入支线上(作为一实例);还可使用更多或更少级。也不必使级联滤波器的每一区段具有频域中的相同值或滑离点以创建特定响应,例如所属领域的技术人员已知的贝塞耳(Bessel)、切贝雪夫(Chebychev)或其它滤波器响应。并且,ESIS滤波器不限于级联单极滤波器,且可采取此项技术中已知的其它形式。
测试电路906可提供相对尖锐瞬态信号用于测试下文描述的调搏器电路,作为身体佩带的监视器100“加电自行测试”的一部分。电阻器R99和R100可拉动差动放大器508的输出,从而允许微控制器(512)检测哪一电极(如果有的话)已分离,非常像通过具有引线的ECG监视器实现“引线失效”检测。身体佩带的监视器100不使用引线,但生理学传感器的一者或两者仍有可能移出病人的身体。此类断开可在身体佩带的监视器100部分移离其非永久固定的身体的情形中发生。电极109的一者或两者处的输入阻抗在传感器关闭(传感器断开)事件中变化。当附接到病人时,放大器508通常具有接近零伏的输出电压。然而,如果电极109的一者脱落,那么电阻器R99和R100致使放大器508的输出移动到最正输出(“正轨道”)或移动到最负输出(“负轨道”)。注意,在单一馈电电路操作的情况下,负轨道可以是接近零的小电压,且两个输入可被拉动到同一轨道。引线失效检测也可经分析以确定装置何时附接到病人且接着自动进入完全操作模式。此类分析可在低频率下完成。
ESIS滤波器507也可致使调搏器脉冲的时域的拉伸,使得事件由至少一个样本记录,尽管调搏器脉冲本身与ADC样本速率相比具有小的持续时间,且调搏器脉冲有可能在样本之间发生。
图10展示用以实现例如除纤颤期间需要的过电压保护的替代性电路。在图10中,二极管1001防止电极电位变化为远大于一个二极管电压降落(Vcc以上或接地以下)以及电阻器R91和R92限制电流。使用电路保护,例如气体放电管L1和L2(图9)和/或二极管1001(图10)与电阻器R91和R92(通常呈电阻性迹线412的形式)组合,身体佩带的装置可经受住多个至少360焦耳的除纤颤循环。
调搏器电路509检测起搏器脉冲。检测起搏器的一个原因是防止ECG电路因疏忽而将来自起搏器的规则脉冲记为实际心律。起搏器信号与由心脏产生的信号的分离对于产生准确的ECG分析结果以及正确检测实际心律的不存在均很重要。举例来说,起搏器即使在人类心脏已完全衰竭的情况下也继续起作用。
调搏器事件(起搏器信号)通常是通常小于100微秒宽的窄脉冲。由于病人体内的调搏器与ECG电路之间的电容的缘故,如由起搏器在病人心脏处操纵的原本相对方形的调搏器脉冲对于ECG监视器可看上去为具有负的负尖峰信号和向零的指数返回的脉冲,其可能无意中模仿QRS信号。然而,调搏器信号可由模拟微分器辨别且警告微处理器512调搏器的存在且不考虑归因于调搏器信号的相应R-C恢复的难以控制的周期。调搏器检测电路或调搏器电路可产生微处理器中断以通知微处理器发生调搏器事件且及时将相应的生理学信号标记为与调搏器事件相关。调搏器电路509还可在确定病人不在使用起搏器的情况下致使一个或一个以上调搏器相关电路自动断电以实现功率节省。
图11展示可用于确定是否应启用调搏器电路的算法。典型的调搏器检测电路使用从电源(例如,电池204)可用的能量的显著百分比。如果例如在身体佩带的监视器100加电时未检测到调搏器信号,那么可自动停用调搏器电路从而允许较长的电池寿命。由于典型的调搏器电路可使用若干放大器(OpAmps),所以其可消耗多达模拟功率的三分之一,因此在不需要调搏器电路(即,病人不具有起搏器)时限制所述调搏器电路可促成电池寿命的显著改进。所述算法还可提供检查以通过分析心跳可变性而确定所需类型的起搏器是否开始操作(其在身体佩带的监视器100加电时可能不活动)。虽然使身体佩带的装置自动感测起搏器的存在并启用调搏器检测电路可能是有利的,但关于启用还是停用调搏器电路的选择也可通过在外部配置身体佩带的装置来完成。此外部配置可通过硬连线通信连接电缆或经由通信和计算模块102完成,其中通信和计算模块102是能够接收针对远程无线电收发器发送的配置命令的双向无线电收发器通信装置。无线电装置可以是依从802.11的,但一般将使用可较能量有效的较轻量(较简单)协议。适宜的较轻量协议可以是专有的或基于标准的(例如,ZigBee或蓝牙)。身体佩带的生理学监视器100尤其较好地适用于医院环境中,作为集成无线监视网络的一部分。此类监视网络的细节在题为“个人状态生理学监视器系统和结构以及相关监视方法(Personal StatusPhysiological Monitor System and Architecture and Related Monitoring Methods)”的第11/031,736号美国专利申请案中揭示,所述专利申请案全文以引用的方式并入本文中。
图12展示适用于ECG电路块510中的高通滤波器(HPF)。0.5Hz HPF的一优点是较快从归因于病人移动、除纤颤、电烙术等的DC偏移中恢复。然而,如果HPF截止大于约0.05Hz,那么ST段分析受到不利影响。因此,优选地具有在0.5与0.05Hz截止频率之间变化的能力。图12的高通滤波器由配置为负反馈电路中的逆转放大器的低通滤波器实施,以给出从电路输入到输出的净有效高通传递函数。复合滤波器的转角频率可通过在电阻器R2′中切换来调节。或者,S1可以周期性速率切换以将工作循环置于C上。注意,S1的切换频率应相对于抗混叠低通滤波器的转角频率较快。图13的曲线A-D进一步说明图12的示范性滤波器的性能。这些曲线在垂直轴上展示标准化振幅,其是相对于水平轴上的频率描绘的。图13曲线A表示原始输入信号。图13曲线B和C是表示高通滤波器和低通滤波器区段的伯德图(Bode Plot)。在将滤波器响应B和C施加到输入数据A之后,经滤波数据D为结果。HPF截止可为0.5Hz或某一较低值,这取决于R2′是否正接入或C是否经工作循环。
实现此频率变化的另一方法是使用在微处理器512上实施的数字滤波器来逆转0.5Hz HPF的效果,接着在较低截止频率(例如,0.05Hz)下实施数字HPF。应知道0.5Hz滤波器的响应以实施反向滤波器。此响应可通过使用微处理器512触发测试电路906而创建一脉冲H(s)来测量。反向响应是[1-H(s)](图13,曲线E),且此反向滤波器可通过所属领域的技术人员熟悉的方法以数字方式实施。H′(s)是具有较低截止频率(标称为0.05Hz)的新HPF的频率响应。针对H′(s)的数字滤波器是以数字方式产生(F)且连同[1-H(s)](图13,曲线E)一起施加,从而形成图13曲线G中显示的频率响应。适用于ECG电路块510中的高通滤波器可由可在微处理器512上运行的软件完全或部分实施。
图14展示配置为ECG监视器的身体佩带的监视器100可如何在至少两个不同定向上定位于病人身上以测量不同心脏向量。通过从病人右肩到左臀的定向来测量主要心脏向量,如位置1401所示。在存在损伤的情况下或在病人人体使得其导致优选位置1401不太合乎需要的情况下,替代位置1402可更适宜。并且,身体佩带的监视器100可固定到病人703的侧部(类似于由常规ECG“V”引线进行的测量)或病人703的背部(例如,在病人需要趴着睡觉的情况下)以监视另外其它ECG向量(未图示)。实际上,身体佩带的监视器100可经放置以拾取可由电极109遍历的特定向量。举例来说,可以此方式使至少前三个主要心脏向量(即,I、II和III)可方便地使用。
虽然以内部电池说明,但重要的是注意,身体佩带的生理学监视器100可仅由内部电源、仅由外部电源,或由内部或外部电源供电。内部电源可以是可更新电源,例如可再充电电池。
另一类型的内部电源是相反操作的珀耳帖(Peltier)装置,也称为塞贝克(Seebeck)装置。塞贝克发现,导体在经受温度梯度时产生电压。热电偶是能够从温度梯度产生电功率(称为塞贝克效应)的固态装置。(相比之下,珀耳帖效应是指电能转换为温度梯度的情形。)塞贝克装置“偶(couple)”由一个N型和一个P型半导体小球组成。温差致使电子在N型偶中从热流向冷,且空穴在P型偶中从热流向冷。为了形成电动势(EMF),进行以下连接:在冷侧(即,暴露于室温的一侧)将小球接合,且在热侧(即,病人侧)将小球连接到一负载,例如计算和通信模块102。塞贝克装置的断路电压由V=SΔT给出,其中S是以伏/°K计的塞贝克系数,且ΔT是热侧与冷侧之间的温差。如今从具有与计算和通信模块102相同尺寸的塞贝克装置对计算和通信模块102完全供电是一项挑战。当前,塞贝克装置仅可提供补充功率,但随着电子元件朝较低功率迁移且塞贝克系数和热电偶密度改进,塞贝克装置可成为针对身体佩带的监视器的可行的长期功率解决方案。其它产生能量(例如,机械(如一些手表中所使用)和太阳能)的方法也可以是为身体佩带的监视器提供可更新的自含式电源的可行的方法。
转向适合在身体佩带的监视器上使用的分析例程,通常,例如通过在时域中使用小波或傅立叶变换和/或匹配的滤波器分析进行的ECG心跳拾取可能计算量较大。将QRS脉冲建模为具有交替极性的三个三角形形成针对QRS脉冲的粗略匹配的滤波器。取脉冲函数中处于三角形的峰处的第二衍生结果(其中第一衍生是不连续的),且所有其它点为零。第二衍生方法还使与传入数据的卷积极其有效,因为大多数乘数具有0作为被乘数且需要最少的计算。可接着对结果进行两次求积分以产生匹配的滤波器输出,其可被馈送到提供基准标记的心跳拾取算法中。使用形状上为正弦形的第二匹配的滤波器以及借助适当鉴别器,系统可提供对危害生命的心律失常(LTA)的指示;即,心搏停止、心室纤颤和心动过速。虽然此系统的准确性与高端心律失常解决方案(例如,由例如摩托拉(Mortara)提供的那些解决方案)相比不太有竞争力,但滤波器可经调谐以出错误肯定(false positive)的差错,且当有肯定LTA响应时,激活全波形的传输。
研究还已展示,对ECG波形间隔统计的R-R部分的分析可提供预测心房扑动(atrialflutter)的方法。应用这种和其它低计算成本方法可允许身体佩带的监视器装置在其它心律失常的机率较高时开始通过较强大的引擎传输用于临床或算法分析的全波形。仅传输ECG波形的R-R间隔是有损失数据压缩方法的一实例。R-R间隔包括数据串,且所述数据串也可被压缩。可实施整个波形的无损失或有损失数据压缩来节省电池寿命,包含不在T形波与P形波之间传输(或可能甚至不取样)数据。因为数据压缩导致将传输较少的数据,所以所节省的功率可弥补数据压缩的计算成本。
虽然我们已在本文中经常参考ECG应用,但应用低密集度计算方法作为功率节省措施同样较好地适用于其它类型的低功率传感器,包含(但不限于)EEG、SPO2、温度和侵入性或非侵入性血压测量。虽然身体佩带的医用监视器执行复杂的分析或简单地将单一数值与单一数值限制进行比较,但所述装置可在低功率无线电状态中起作用,直到超过预定阈值为止。身体佩带的监视器还可周期性地发送数据或在有外部请求时发送数据。另外,外部装置可发送命令以修改操作参数和阈值。
转向其它通信问题,可能发生其中无上行链路可用的不利事件。在无上行链路(失败的通信)的情况下,身体佩带的监视器可缓冲对应于任何不利事件的印有时戳的波形。缓冲器还可存储波形以供稍后分析,其中此存储由病人在病人辨别出一情形(例如,胸痛)时触发。在当无上行链路时发生的警报的情况下,警报可经配置以被锁存直到临床医师确认为止。优选地,非连续数据被标记(时戳、样本号)以允许非连续数据与连续数据的相关,且还标记数据以指示何时启始警报以供稍后数据分析,包含算法性能分析。
在许多身体佩带的监视器装置彼此紧密接近而使用的那些情形中,可存在来自一个身体佩带的监视器的报告可能与来自另一身体佩带的监视器的报告互换的问题。本文提供的身体佩带的监视器可以病人背景资料(即、姓名、病房号、病人ID、年龄等)配置,且可只要监视器连接到病人就维持所述背景资料以避免此类问题。身体佩带的监视器可经由连续生命体征监视器、压力、温度、流电响应或类似输入而确定其到病人的连接的状态。在检测到与病人的连接丢失时,所述装置可依据不同的可变设定擦除病人背景资料或当重新连接到病人时要求护理者确认病人背景资料。当身体佩带的监视器初始加电或连接到病人时,其可在系统稳定时具有用于警报的时间释放(time holdoff)以防止错误的警报(例如,低心率、引线失效检测)。
关于固件更新,在医院存在大量身体佩带的监视器的情况下,保持其全部以最新版本的固件加以更新可能有问题。此问题的一种解决方案是提供无线更新能力以将新固件和/或配置下载和安装到所有身体佩带的监视器中。
虽然已参考如图式中说明的优选模式明确地展示和描述本发明,但所属领域的技术人员将了解,可在不脱离如由所附权利要求书界定的本发明的精神和范围的情况下在其中实行细节上的各种变化。应进一步了解,本发明的若干方面,包含(但不限于)除纤颤保护电阻器、调搏器检测电路停用、ECG信号高通滤波的方法以及各种其它低功率模式,并不限于身体佩带的监视器,且可用于任何类型的ECG监视器中。
Claims (58)
1.一种身体佩带的病人监视装置,其包括:
至少一个一次性模块,其包含多个电连接,所述电连接可耦合到皮肤表面以测量生理学信号,所述至少一个一次性模块包含一次性模块连接器;
至少一个内部或外部电源,其用以对所述身体佩带的病人监视装置供电;以及
至少一个通信-计算模块,其具有通信-计算模块连接器以经由所述一次性模块连接器从所述至少一个一次性模块接收生理学信号,所述通信-计算模块包含:至少一个微处理器,其用以有效监视病人并执行对所述生理学信号的实时生理学分析;以及无线电电路,其用以在预定时间或在预定事件发生时经由到远程无线电接收器的无线电传输来传送未经处理的生理学信号或所述生理学分析的结果,其中所述至少一个一次性模块以机械和电方式直接耦合到所述至少一个通信-计算模块,且包含所述至少一个一次性模块和所述至少一个通信-计算模块的所述身体佩带的病人监视装置直接非永久性地固定到所述病人的所述皮肤表面。
2.根据权利要求1所述的身体佩带的装置,其中到身体的所述多个电连接包括到所述身体的直接电连接和到所述身体的间接电连接中的至少一者。
3.根据权利要求2所述的身体佩带的装置,其中到所述身体的所述间接电连接包括到所述身体的电容性连接。
4.根据权利要求1所述的身体佩带的装置,其中所述身体佩带的病人监视装置包括ECG监视器,且所述电连接中的至少两者为ECG电极。
5.根据权利要求4所述的身体佩带的装置,其中所述ECG电极包括加网印刷到柔性衬底上的材料。
6.根据权利要求5所述的身体佩带的装置,其进一步包括至少一个串联电流限制电阻器以在病人除纤颤事件期间保护所述通信-计算模块。
7.根据权利要求6所述的身体佩带的装置,其中所述至少一个串联电流限制电阻器包括加网印刷在所述柔性衬底上的电阻器。
8.根据权利要求7所述的身体佩带的装置,其中从所述至少一个串联电流限制电阻器到所述ECG电极的机械界面包含有圆角边缘。
9.根据权利要求7所述的身体佩带的装置,其中从所述至少一个串联电流限制电阻器到所述ECG电极的所述机械界面包括重叠层。
10.根据权利要求9所述的身体佩带的装置,其中所述重叠层包括加网印刷在传导表面上的碳电阻性层,所述碳电阻性层具有与所述传导表面大体相同的形状。
11.根据权利要求6所述的身体佩带的装置,其进一步包括覆盖所述至少一个串联电流限制电阻器以防止起弧的绝缘材料。
12.根据权利要求5所述的身体佩带的装置,其中所述ECG电极大体形成为环带的形状。
13.根据权利要求12所述的身体佩带的装置,其中所述环带包括传导墨。
14.根据权利要求5所述的身体佩带的装置,其中所述衬底经定形以允许放置在所述病人身上以监视一组标准ECG向量中的至少一者,同时减少相应ECG向量信号中的运动和肌肉伪影。
15.根据权利要求1所述的身体佩带的装置,其中所述至少一个电源是所述身体佩带的装置内部的可更新电源。
16.根据权利要求1所述的身体佩带的装置,其中所述至少一个电源包括可再充电电池或一次性使用电池。
17.根据权利要求1所述的身体佩带的装置,其中所述至少一个电源是包含在所述一次性模块内的电池。
18.根据权利要求1所述的身体佩带的装置,其中所述至少一个电源是塞贝克装置。
19.根据权利要求1所述的身体佩带的装置,其中所述电连接中的一者是可用于改进共模抑制(CMR)的参考电极。
20.根据权利要求1所述的身体佩带的装置,其进一步包括虚拟电极作为参考电极以改进CMR。
21.根据权利要求20所述的身体佩带的装置,其中所述虚拟电极是位于所述病人的皮肤附近但不直接连接到所述皮肤的电极。
22.根据权利要求20所述的身体佩带的装置,其中所述虚拟电极包括所述通信-计算模块的主体到所述病人的所述皮肤表面的电容性耦合以减小功率线频率干扰。
23.根据权利要求20所述的身体佩带的装置,其包含用于在使用所述虚拟电极作为所述参考电极与使用直接连接的电极作为所述参考电极之间进行选择性选择的参考电极开关,且其中当所述参考电极开关选择所述虚拟电极时,所述直接连接的电极可用作额外ECG电极。
24.根据权利要求20所述的身体佩带的装置,其中所述参考电极是无源电连接,或所述参考电极是有源驱动的。
25.根据权利要求1所述的身体佩带的装置,其中所述通信-计算模块包含调搏器检测电路。
26.根据权利要求25所述的身体佩带的装置,其中所述调搏器检测电路产生微处理器中断以通知所述微处理器发生了调搏器事件。
27.根据权利要求26所述的身体佩带的装置,其中所述微处理器中断用于及时将相应的生理学信号标记为与调搏器事件有关。
28.根据权利要求26所述的身体佩带的装置,其中所述装置自动确定病人是否具有起搏器且仅在存在起搏器时才启用所述调搏器检测电路。
29.根据权利要求26所述的身体佩带的装置,其中所述装置由外部输入配置以启用或停用所述调搏器检测电路。
30.根据权利要求1所述的身体佩带的装置,其中所述身体佩带的装置包含电路保护以允许所述装置经受住多个至少360焦耳的除纤颤循环。
31.根据权利要求30所述的身体佩带的装置,其中所述电路保护包括一气体放电管或多个二极管以钳制或限制来自所述电连接的信号。
32.根据权利要求30所述的身体佩带的装置,其中所述电路保护的多个组件分布在所述一次性模块与所述通信-计算模块之间。
33.根据权利要求1所述的身体佩带的装置,其进一步包括具有可选择转角频率以对所述生理学信号进行滤波的高通滤波器。
34.根据权利要求33所述的身体佩带的装置,其中所述转角频率由开关可选择电阻选择。
35.根据权利要求33所述的身体佩带的装置,其中所述转角频率由一个或一个以上开关电容器选择,所述开关电容器以比低通抗混叠滤波器的所述转角频率高的速率切换。
36.根据权利要求33所述的身体佩带的装置,其中所述高通滤波器实施于在所述微处理器上运行的软件中。
37.根据权利要求1所述的身体佩带的装置,其中所述身体佩带的装置本身通过将所模拟调搏器脉冲注射到前端放大器中以通过模拟病人的起搏器的存在而模拟调搏器检测电路,来检查所述调搏器检测电路。
38.根据权利要求1所述的身体佩带的装置,其中所述通信-计算模块包含电路组件以检测与所述病人的所述皮肤表面的所述电连接中的一者或一者以上的接触的失败。
39.根据权利要求1所述的身体佩带的装置,其中通过电外科隔离抑制电路而保护所述通信-计算模块免受外部高能量信号的影响。
40.根据权利要求1所述的身体佩带的装置,其中所述微处理器在模拟到数字转换器(ADC)的转换循环期间自动进入休眠模式以使来自所述身体佩带的装置上的数字电路的噪音拾取最小化。
41.根据权利要求1所述的身体佩带的装置,其中在所述身体佩带的装置中的微处理器上运行的算法致使所述身体佩带的装置进入低功率模式,所述低功率模式从一个心跳结束时的“T形波”的结束到下一心跳开始时的“P形波”的开始停用所述身体佩带的装置的至少一个电路以节省功率。
42.根据权利要求4所述的身体佩带的装置,其包含ESIS滤波器,所述ESIS滤波器具有足够低的转角频率使得来自调搏器脉冲的能量由至少一个样本记录,即使所述调搏器脉冲本身与取样速率相比具有较小持续时间且所述调搏器脉冲在样本之间发生。
43.根据权利要求1所述的身体佩带的装置,其中从生理学传感器连接到电子元件共点(接地)的氖灯泡保护所述通信-计算模块的一个或一个以上内部电路免受除纤颤脉冲的影响。
44.根据权利要求1所述的身体佩带的装置,其中设置在所述生理学传感器与电子元件共点(接地)之间的多个二极管保护所述通信-计算模块的一个或一个以上内部电路免受除纤颤脉冲的影响。
45.一种为身体佩带的监视器提供高电压电路保护的方法,其包括以下步骤:
提供支撑到病人身体的一个或一个以上电连接的衬底;
确定待印刷于所述衬底上的具有第一电阻率的第一材料的印刷图案和厚度;
确定待印刷于所述衬底上的具有第二电阻率的第二材料的印刷图案和厚度;
将所述第一材料印刷到所述衬底上;以及
将所述第二材料印刷到所述衬底上,其中所述第二材料的至少一部分覆盖所述第一材料。
46.根据权利要求45所述的方法,其中所述确定所述第一和第二材料两者的印刷图案和厚度的两个步骤包括额外步骤:确定包含有圆角截面的所述第一和第二材料两者的印刷图案和厚度。
47.根据权利要求45所述的方法,其中所述确定所述第一和第二材料两者的印刷图案和厚度的两个步骤包括进一步步骤:确定所述第一和第二材料两者的印刷图案和厚度以实现总电阻值。
48.根据权利要求45所述的方法,其中所述确定所述第一和第二材料两者的印刷图案和厚度的两个步骤包括进一步步骤:确定所述第一和第二材料两者的印刷图案和厚度以实现所述印刷图案的两个或两个以上电迹线之间的间隔,以及在所述印刷所述第二材料的步骤之后施加绝缘层。
49.一种ECG监视器,其包括:
包含至少一个电极的多个电连接,所述电连接可耦合到皮肤表面以测量病人心跳信号;
至少一个内部或外部电源,其用以对所述ECG监视器供电;
至少一个电流限制除纤颤保护电阻器,所述至少一个电流限制除纤颤保护电阻器包括加网印刷到衬底上的电阻器;以及
ECG电子元件模块,其用以从所述多个电连接接收并处理病人心跳信号,其中所述至少一个电流限制除纤颤保护电阻器以电方式设置在所述多个电连接中的至少一者与所述ECG电子元件模块之间。
50.根据权利要求49所述的ECG监视器,其中所述至少一个电流限制除纤颤保护电阻器包括加网印刷到柔性衬底上的电阻器。
51.根据权利要求49所述的ECG监视器,其中从所述至少一个串联电流限制电阻器到所述至少一个ECG电极界定机械界面,所述机械界面包含有圆角边缘。
52.根据权利要求49所述的ECG监视器,其中从所述至少一个串联电流限制电阻器到所述至少一个ECG电极界定机械界面,所述机械界面包含多个重叠层。
53.根据权利要求52所述的ECG监视器,其中所述多个重叠层包括加网印刷在传导表面上的碳电阻性层,所述碳电阻性层具有与所述传导表面大体相同的形状。
54.一种ECG监视器,其包括:
多个电连接,所述多个电连接可耦合到皮肤表面以测量病人心跳信号;
至少一个内部或外部电源,其用以对所述ECG监视器供电;以及
ECG电子元件模块,其用以从所述多个电连接接收并处理病人心跳信号,且包含调搏器检测电路以检测起搏器的存在或不存在,所述ECG电子元件模块汲取功率以作为所述电源上的电负载,其中所述调搏器检测电路在检测到正由所述ECG监视器监视的病人体内不存在起搏器信号后,致使所述ECG电子元件模块停用所述调搏器检测电路以便减少所述电源上的所述电负载。
55.根据权利要求54所述的ECG监视器,其中所述电源是电池。
56.一种改进ECG信号高通滤波的方法,其包含以下步骤:
提供具有一经编程微处理器和多个电连接以测量病人心跳信号的ECG监视器;
以具有模拟高通截止频率的模拟高通滤波器对所述测量的心跳信号进行滤波;
以数字反向滤波器算法移除所述模拟高通滤波器的影响,从而产生实质上未经滤波的心跳信号;
使用具有低于所述模拟截止频率的数字高通滤波器截止频率的数字滤波器以数字方式对所述实质上未经滤波的心跳信号进行滤波。
57.根据权利要求56所述的方法,其中所述以模拟高通滤波器对所述测量的心跳信号进行滤波的步骤包括以下步骤:以具有0.5Hz模拟高通截止频率的模拟高通滤波器对所述测量的生理学信号进行滤波,且所述以数字方式对所述实质上未经滤波的心跳信号进行滤波的步骤包括以下步骤:使用具有数字0.05Hz高通滤波器截止频率的数字滤波器以数字方式对所述实质上未经滤波的心跳信号进行滤波。
58.一种ECG监视器,其包括:
多个电连接,所述电连接可耦合到皮肤表面以测量病人心跳信号;
至少一个内部或外部电源,其用以对所述ECG监视器供电;以及
ECG电子元件模块,其用以从所述多个电连接接收并处理心跳信号,所述ECG电子元件模块汲取功率以作为所述电源上的电负载,所述ECG电子元件模块包含微处理器以处理心跳信号,其中在所述微处理器上运行的算法致使所述ECG监视器进入低功率模式,所述低功率模式从一个心跳结束时的“T形波”的结束到下一心跳开始时的“P形波”的开始停用所述ECG电子元件模块的至少一个电路,以便减少所述电源上的所述电负载。
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US8965492B2 (en) | 2015-02-24 |
US20160029917A1 (en) | 2016-02-04 |
US9877663B2 (en) | 2018-01-30 |
US20140100467A1 (en) | 2014-04-10 |
EP2081488A2 (en) | 2009-07-29 |
EP2081488A4 (en) | 2017-06-28 |
WO2008057884A2 (en) | 2008-05-15 |
US20120238890A1 (en) | 2012-09-20 |
US8214007B2 (en) | 2012-07-03 |
US20190110709A1 (en) | 2019-04-18 |
US20140243694A1 (en) | 2014-08-28 |
WO2008057884A3 (en) | 2008-07-17 |
US20150126848A1 (en) | 2015-05-07 |
EP2081488B1 (en) | 2020-05-06 |
US9433366B2 (en) | 2016-09-06 |
US20180146877A1 (en) | 2018-05-31 |
US9155484B2 (en) | 2015-10-13 |
US8630699B2 (en) | 2014-01-14 |
US20160029918A1 (en) | 2016-02-04 |
US10159422B2 (en) | 2018-12-25 |
US20160354003A1 (en) | 2016-12-08 |
CN101534706B (zh) | 2011-08-17 |
US10939839B2 (en) | 2021-03-09 |
US8750974B2 (en) | 2014-06-10 |
US20080139953A1 (en) | 2008-06-12 |
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