CN104812296B - 穿戴式心脏监视器 - Google Patents
穿戴式心脏监视器 Download PDFInfo
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- CN104812296B CN104812296B CN201380052381.1A CN201380052381A CN104812296B CN 104812296 B CN104812296 B CN 104812296B CN 201380052381 A CN201380052381 A CN 201380052381A CN 104812296 B CN104812296 B CN 104812296B
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Abstract
用于减小心脏监视中的噪声的系统、方法和设备包括穿戴式监视设备,穿戴式监视设备具有至少一个用于心脏监视的电极;在某些实施方式中,穿戴式设备使用的复合粘合剂具有施加在电极附近的至少一个导电部分;以及,在某些实施方式中,包括适应于至少一个电极以代理右腿驱动电极的电子线路。
Description
相关申请的交叉参考
本PCT国际阶段申请要求2013年3月15日递交的非临时专利申请US 13/837748的权益和优先权,并且还要求2012年10月7日递交的临时申请US 61710768的权益和优先权,以上两个申请的全部内容、启示和建议均以参考方式完全包含在本申请中。
背景技术
电子技术、传感器技术和材料科学的发展使得患者监视技术发生了翻天覆地的变化。尤其是,许多轻便的穿戴式设备可用于各种心脏监视应用中。然而,仍然需要提供鲁棒穿戴式设备的改进,该鲁棒穿戴式设备提供高效的数据收集,并且在某些情况下还提高了患者便利性和舒适性。其他替代方式可以包括对于设备附接、尺寸、灵活性、数据传输及其他方面中的一个或更多方面的改善。
用于心脏病患者及其医师的其他替代方式则可以包括鲁棒且便利的个人心脏监视器,该个人心脏监视器在某些情况下可以收集并传递长期数据,以及可以实时监视事件。
发明内容
本发明说明了多个医疗监视设备和系统,在某些实例中用于诸如婴儿、运动员或心脏病患者之类的个体的心脏和/或呼吸数据长期传感和/或记录。本发明之后并在整个说明书中总结和/或列举了若干替代性实施方式和应用。
在一个方面,本发明的发展包括:一种用于根据由多个传感器收集的时间一致测量值监视个体的多个生理参数的穿戴式设备,多个电极包括但不限于以下电极:用于测量心电图(ECG)的电离势改变的电极、诸如LED光电二极管对之类用于基于光学的氧饱和度测量的光源和光检测器、用于运动和活动测量的xyz加速计,诸如此类。在某些实施例中,本发明的发展的方法和设备包括一电路,该电路模仿右腿驱动电路(本申请中有时称为“代理右腿驱动电路”)以允许减小常规粘附到或者能够被粘附到个体上的小型封装设备中的共模噪声。
在另一方面,本发明的发展包括用于根据时间一致的脉搏血氧测定信号和ECG信号来测量氧饱和度参数的方法和/或设备。在一个实施例中,ECG信号可以被用于限定脉搏血氧测定法数据的间隔或“帧”,脉搏血氧测定法数据被收集并求平均值以确定脉搏血氧测定信号的恒定分量和主要周期分量(即DC分量和AC分量),根据恒定分量和主要周期分量则可以确定氧饱和度的值。这样的实施例的使用脉搏侧血氧测定方法和ECG传感器的患者穿戴式设备当放置在患者的胸部以用于这样的信号采集时尤其有用。
这些以及其他方面在若干所示的替代性实施方式和应用中列举,其中的某些在图中示出并且在之后的权利要求部分进行表征。然而,正如一般技能的技术人员所理解的,以上综述以及以下的详细说明并非说明本发明的全部范围,并且并非用于说明本发明的每个所示实施例或每个实施方式,也不是提供对以下给出的本发明的权利要求或保护范围的限制。
附图说明
在以下附图中:
图1包括子图1A-1H,示出了本发明的多个替代方式,其中包括设备的各种等比例俯视图、仰视图和立面图,以及替代性的导电粘合剂结构;
图2包括子图2A-2C,提供了右腿驱动电路的替代方式的电路图;
图3为包括替代性使用方法的流程图;
图4示出了令本申请中的实施方式得以使用的示例性计算机系统或计算资源;
图5包括子图5A-5D,提供了根据本发明的替代性软件实施方式的替代性截图;
图6A-6B示出了用于使用脉搏血氧测定信号和心电图信号来测量氧饱和度的一个实施例的特征;
图6C为示出了用于确定氧饱和度值的一个实施例的步骤的流程图;
图6D-6E示出了用于确定呼吸深度值的一个实施例。
具体实施方式
虽然本发明具有各种修改和替代形式,但是本发明的具体方式借助于附图和以下说明给出。然而,应当理解,本发明并不限于所述特定实施例。本发明涵盖了在本发明的精神和范围内的全部修改、等效和替代,这些修改、等效和替代在本申请中进行说明,或者即便并未以文字方式给出也足以被理解为包括在本申请中。
在一个方面,本发明的系统可以包括用于监视生理参数的设备,生理参数例如为以下各项中的一个或更多:心电图(亦称EGG或EKG)、光电血管容积图(亦称PPG)、脉搏血氧测定法、和/或患者加速度或移动信号。本发明的系统可以被建立用于使用或包括以下元件中的一个或更多来测量和处理患者的此类信号:(a)电路,该电路在弹性或柔性电路板之中或之上或者形成该电路板,所述电路板被嵌入在具有上表面和下表面的平整弹性基板或板中,该电路具有(i)至少一个传感器,该传感器被安装在平整弹性表面的下表面之中或邻近,该至少一个传感器能够与患者电连通或光连通,(ii)至少一个信号处理模块,用于接收和/或接受来自该至少一个传感器的信号,并且在某些实施方式中还对这样的信号进行转换以将其储存为患者数据,(iii)至少一个存储器模块,用于接收和/或接受并存储患者数据,(iv)至少一个数据通信模块,用于将存储的患者数据传输到外部设备,以及(v)控制模块,用于对上述至少一个传感器、以及上述至少一个信号处理模块、至少一个存储器模块、至少一个数据通信模块中的一个或更多,和/或控制模块的定时和操作进行控制,其能够接收命令以通过该至少一个数据通信模块实现患者数据的传递并且将患者数据从至少一个存储器模块中擦除和/或清除;以及(b)导电粘合剂,该导电粘合剂可移除地粘附到平整弹性基板的下表面,导电粘合剂能够仅在与平整弹性基板的下表面基本垂直的方向上粘合患者的皮肤并导电电信号,和/或在某些实施方式中,导电粘合剂能够包括与传感器或多个传感器邻近的导电部分以及非导电部分。在某些实施方式中,导电粘合剂为各向异性导电粘合剂,其中包括基本只在垂直于皮肤的方向上导电电流(即,“z轴”导电)的材料区域。
在某些实施方式中,本发明的设备用于综合长期心脏监视。本发明的特征可以包括导联1ECG、PPG、脉搏血氧测定仪、加速计以及用于进行手动患者事件标记的按钮或其他指示器中的一个或更多。这样的设备适于存储多达例如两周的连续数据(尽管在替代性实施方式中还可以存储更长时间的连续数据),这些连续数据经由计算机连接在仅为90秒左右的短时间内被下载到门诊计算机或其他计算机上(尽管在替代性实施例方式中还可以更短),该计算机连接为有线或无线数据连接,并且在一个示例中使用USB,又或者使用其他可用的数据连接。配套的软件数据分析包可以适于提供自动时间捕获和/或允许进行即时本地数据解释。
医师通常很难对间歇心脏异常进行检测和/或诊断,这是因为通常只有在对患者进行体检期间出现异常才能进行对其检测和/或诊断。本发明的设备解决了这一问题,该设备在某些实施方式中可以对若干生命体征进行连续或者基本连续的监视。
某些替代性特征可以包括:(i)“右腿”驱动电路,其电极仅位于胸部上;(ii)“z轴”或各向异性导电粘合剂电极接口,仅可以允许电极与该电极正下方的患者皮肤之间的电连通;(iii)数据传输至可被CCU/ICU工作人员访问的本地计算机并由该计算机进行解释;(iv)硬件的独特组合使得能够对多个数据源进行时间一致性关联以协助诊断。
在某些替代性实施方式中,本发明的设备和系统可以提供(1)重复利用(在某些情况下,可重复用于接近或超过1000名患者),使得经过10至15次患者测试即可收回该设备的成本;(2)心电图波形数据、惯性施加感应、手动事件标记和/或脉搏血氧测定仪中的一个或更多,以上所述中的任一项或全部时间上一致以更好地检测和分析心律失常事件。(3)高效不透水或防水(患者甚至能够在穿戴该设备的同时游泳),以及(4)综合分析包,用于即时对本地数据进行解释。一个替代性设备可以适用于利用柔性电路技术,从而提供一种重量轻、薄、耐用并且灵活贴合患者皮肤的设备。
图1和2示出了可以如此适应不同环境的设备的替代性实施例的示例。
图1示出了设备100,设备100具有组件侧或上侧101、患者侧或电路侧102、总体上由附图标记103进行标记的一个或更多内电层、以及狭长条带层105。条带层105的上方和/或内部可以具有电子器件。图1A等比例示出了以上组件以及本申请中可能使用的其他元件。图1B更具体地涉及上侧101的平面图,并且图1C则涉及下侧的患者侧102的平面图,并且图1D则为第一立面侧视图。
本发明中的许多电子器件能够位于电子器件层103中,并且正如附图中总体上示出的,电子器件可以被封装在材料104中(例如,参见图1A、1B和1D)以将电子器件固定在电子器件层103之上或之中的工作位置处,又或者相对于狭长条带105进行功能性地布置,材料104为塑料或类似材料又或者灌封材料。在许多实施方式中,灌封材料或者其他材料还可以或者替代性地可以为电子器件提供防水或水密或阻水覆盖,从而保证电子器件即便是在水中或者流汗的使用环境中也能够工作。一个或更多接入点、接合点或者其他功能单元106可以被设置在封装材料104的任何一侧上或者穿过封装材料104的任何一侧以用于从外部接入电子器件和/或与电子器件通信。图1A、1B和1D示出了上侧上的四个这样的接入点106。这些接入点可以包括高Z的数据通信端口和/或充电触点等等。设备100的该上侧或组件侧101表面覆盖有硅酮化合物以用于保护和/或防水,在某些示例中,仅有高速USB(HS USB)接头经过一个或更多端口106暴露在外,例如用于数据通信或数据传递和/或充电。
狭长条带层105可以是或者可以包括诸如电引线或其他内层导体之类的电路或电路部分,例如,图1D中示出了用于电子器件103之间通信的导线107,以及以下将进一步描述的电导电衬垫或接触点108、109和110(在某些示例中,108和109为用于心电图ECG的高阻抗/高Z的银或铜/银电极,并且110有时为参考电极)。在许多实施方式中,条带层105可以是或者可以包括柔性电路,该柔性电路被理解为提供可接受的形变、扭曲、弯曲等等,并且依然保持柔性电路内的鲁棒电线路连接。应该注意的是,尽管电子器件103和电极108、109、110被示为附接到层105上;顶部附接电子器件103,并且底部或患者侧附接电极108、109、110;但是这样的元件还可以形成在层105中又或者置于层105内,又或者至少被相对无差别地置于实际上具有或者邻近层105的一个或更多层中的相对工作位置上。类似地,引线或迹线107示为被嵌入(由图1D中的虚线表示);然而,即便引线或迹线更有可能在上侧以绝缘于其他的皮肤侧电连通,但是引线或迹线107可以在上侧或下侧。如果一开始位于上侧(或下侧),则迹线随后可以覆盖有绝缘密封剂或相似的保护覆盖物(并未独立示出),在许多实施例中保护性覆盖物是柔性材料以维持层105的整体柔性或者其大部分的柔性选择。
在患者侧102上,ECG电极108、109和110可以露出以用于基本直接的患者皮肤接触(尽管在二者之间有可能至少涂抹导电胶);和/或,在许多实施方式中,患者侧电极108、109和/或110可以被如下所述的导电粘合材料覆盖。电极可以是鲁棒高导电材料或者镀有鲁棒高导电材料,例如,银/氯化银以获得生物相容性以及高信号质量,并且在某些实施方式中,可以具有强鲁棒性,对于一个非限定示例,则适于经受不同患者之间超过大约1000次的酒精清洗循环。脉搏血氧测定仪可以设置有窗口或其他通信通道或开口111、112,例如,LED和传感器。这样的开口111、112通常可以被布置以获得到达或来自患者的最佳光通信。图1D中的非限定示例示出了一个或更多光导管111a/112a的替代性布置,其中的一个或更多光导管111a/112a被布置得更靠近电子器件103和/或被连接到电子器件103上。本申请中可使用多种替代性放置。
在某些实施方式中,可以提供对环境光(LED熄灭)的采样,并且随后从每个脉冲ox信号中减去环境光以抵消由太阳光或其他环境光源引起的噪声。
LED和光电二极管传感器还可以和/或替代性地可以覆盖有一层硅酮,从而除去传感器/LED与患者皮肤之间的任何空气间隙。一个这样的示例在图1H中给出,其中,硅酮层121被示出覆盖/围绕传感器/LED 111a/111b/112a。LED 111a可以是红光LED,LED 111b可以是IR(红外光)LED,并且器件112a可以是传感器。这可以减少皮肤反射出去的光损失,并借此大幅增大了信号,同时减小了由于皮肤相对于传感器的运动引起的噪声。在某些实施方式中,该硅酮被指出可以是光管,并且在某些情况下可以是清洁、无色和/或医用级别的硅酮。
图1D提供了可以在本申请中使用的粘合剂113的第一示例。粘合剂层113在此为双面粘合剂以施加到设备100的下侧102,并且第二侧可能使用不同类型的粘合剂以用于粘合人类患者的皮肤(未示出)。可使用不同类型的粘合材料因为对粘合剂层将要附接的材料的选取是不同的;典型地,将要附接的材料为用于连接到设备100的电路或电路板材料,以及患者侧的患者皮肤(未单独示出)。保护性背衬114可以被用在患者侧直到想要应用于患者为止。应当注意的是,在许多应用中,粘合剂113是各向异性的因为其较优地可以仅在单一方向上或基本单一方向上导电,例如,在与粘合剂接触点的表面垂直的轴线上导电。因此,通过这样的粘合剂/粘合剂到接触点或电极108、109和110能够具有信号通信的良好电导电接触。应当注意的是,图1D的示例的粘合剂113中示出了对应的一个或更多光孔隙111b/112b,从而通过一个或更多光孔隙111b/112b传递光,并与层105中或穿过层105的光导管111a/112a配合用于脉搏血氧测定法中典型的光数据通信。
粘合剂因此可以被放置或布置在设备100上,在某些实施方式中基本永久放置或者具有一定的可更换性。在某些实施例中,图1A至1D和/或1G中示出的没有(或在某些实施方式中具有)粘合剂的设备可重复使用。在许多这样的情况中,在每次后续使用之前,粘合剂层113可以被去除并更换,即便层113的后续再使用并未被排除。在可更换粘合剂层113的第一次或后续使用中,将设备施用到患者身上的使用者,例如医师甚至患者自己,将导电传输粘合剂113施加到设备100的患者侧102上。保护性背衬114则可以被去除,并且设备被粘附到患者上并被激活。激活可以采用若干方式进行;在某些情况下,激活可以被预设为可能不需要来自医生或患者等的肯定激活交互,这是因为惯性和/或脉搏血氧测定仪激活可以基本上自动激活,例如,在接收到足够的最小输入时自动激活(在惯性系统情况下的移动,或者脉搏血氧测定仪的血液流动的光反射);然而,可以在接入点106或者邻近电子器件的某些其他位置处提供按钮以允许患者在需要的情况下启动或停止设备又或者标记事件。在一个示例性实施方式中,设备可以被穿戴诸如两周之类的周期以用于基本连贯地收集数据,又或者以本申请的系统中或由本申请的系统所优选或建立的间隔收集数据。
在监视周期结束后,医师、技师、患者或其他人则可以从患者身上取下设备,(在某些情况下使用酒精)去除粘合剂,并且建立用于数据传输的数据通信连接,例如,使用无线通信或者通过插入/连接USB或类似的数据接头以下载数据。数据随后被处理和/或解释,并且在许多情况下,按照需要立即被解释。板载电源可以包括电池组,并且电池组则还能够在使用间隙充电,在某些实施方式中,能够在大约24小时内快速完全充电,之后设备则可以认为准备好用于下一患者。
本申请中可以使用某些替代性导电粘合剂。图1E、1F和1G示出了一种这样的替代性导电粘合剂113a;图1E中的下平面视图以及图1F和1G中替代性导电粘合剂113a的立面侧视图(在图1G中连接到设备100上)。在某些实施方式中,导电性如上所述可以是各向异性的;即便不是完全也是主要在Z轴方向上导电;Z轴方向与图1E中的纸面垂直(垂直纸面向内和/或向外),和/或相对于图1F的实施方式视图中的设备100的水平长轴垂直或横切。
该特定示例的实施方式包括复合粘合剂113a,复合粘合剂113a自身可以包括某些非导电部分113b和某些一个或更多导电部分113c。复合粘合剂113a对于以上所述粘合剂113为双面粘合剂,以使得一侧粘附到患者上而另一侧粘附到设备100的下侧102(参见图1G),以使得一个或更多导电部分113c可以置于或位于与电子监视设备100上电极整合的电连通和/或导电接触点。因为电极在彼此电隔离或电绝缘的情况下作用更好,而每个电极与患者的皮肤电接触或电连通,所以粘合剂进一步可以更加特别地以某些下述实施方式放置。
如图1E和1F中所示,三个隔离的导电部分113c可以又非导电的主体部分113b被彼此分离布置。这些导电部分则对英语上述示例中的电极108、109、110,更尤其是在图1G中概括示出(注意到粘合剂113a的尺度被放大,并且因此并不一定示出与设备100的电极精确匹配)。在某些示例中,电极区113c可以是可能是又或者不是粘合剂的导电性水凝胶,并且在某些示例中,导电性水凝胶可以由粘性导电材料制成,诸如3M Corporation 9880水凝胶粘合剂(3M公司,St.Paul,Minnesota)。这些区域113c则可以通过非导电材料113b彼此隔离,诸如3M Corporation 9836胶带或者双面转移粘合剂9917(3M,St.Paul,MN)或等效物。附加层113d在被使用时可以是3M 9917,并于9836材料制成的113b粘合起来。这些结构体可以提供以下效果:创建电极区域113c的在Z轴方向(垂直于图1E的纸面并且在图1F和1G中为垂直和横向的)上的低电阻抗路径,并且在电极之间在X/Y方向上创建高电阻抗路径。(参见图1E、1F和1G;在图1E中与纸张共面,并且在图1F和1G中与纸面水平和垂直。)因此,合成粘合条带能够保证,不但将设备粘附到患者上,而且无论是两个还是所示的三个电极都通过粘合条带的导电部分导电连接,其中,导电部分和非导电部分的结合则能够减少信号噪声和/或增强无噪声特性。电极相对于皮肤移动能够引入造成;也就是说,通过胶体电连通/连接到皮肤上的电极可以相对于皮肤移动并因此引入噪声。然而,复合粘合剂中连接到各自电极上并基本牢固连接到皮肤上的一个或更多导电性粘合剂部分将保持各个电极基本相对于皮肤固定并借此减少甚至消除电极相对于皮肤的移动。去除这样的移动则会去除噪声,借此提供纯净信号,该纯净信号能够允许对心脏P波,从而提高了检测到无法用其他方式检测到的心律失常的概率。以下给出进一步的说明。
在某些实施方式中,如图113d中所示实现进一步可选的连接和/或绝缘结构113d,从而在设备100的下侧连接到设备100上的电极之间提供进一步的结构和绝缘分离。尽管图1F和1G中所示为分离的,但是这些视图中的连接和/或绝缘结构113d可以与绝缘粘合剂113b毗邻。
连接和/或绝缘结构113d的某些替代性实施方式可以包括右腿驱动ECG电路,具有一个或更多的胸部电极(“驱动胸部电极”)。除了被用于对单个或多个导联心电图信号进行测量的电极以外,设备100还可以使用诸如参考电极110(参见图1A、1C、1D和1G)之类的附加电极来减小共模噪声。这样的电极的工作方式可以与常用的右腿驱动电极相似,但是电极在此处可以位于患者的胸部上而不是患者的右腿上,然而该第三/参考电极可以起到右腿电极的作用。该胸部电极因此可以模仿右腿电极和/或被视为代理右腿驱动电极。适于以此方式工作的电路或者整个电路的一部分可以包括若干放大器级以提供增益,并且滤波以确保电路稳定性和调整整体频率响应。这样的电路可以被偏置以控制心电图信号的共模偏置。该驱动胸部电极实施方式可以与差分放大器或测量放大器共同使用一减小共模噪声。在此情况下,感应电极可以被用作心电图电极中的一个。替代性地,单端心电图放大器可以被用在将差分心电图信号与接地或某些其他的已知电压进行参考的情况中。
如图2中使用晶体管201的电路或子电路200可以是这样的电路(亦称模块),并且因此如图2A中所示可以包括感应电极202、驱动电机203和放大器204。感应电极202和驱动电机203都位于患者的胸部上,以使得两者提供与患者的电连接。放大器204可以包括增益和滤波。放大器输出端被连接到驱动电极上,反相输入端被连接到感应电极上,并且非反相输入端被连接到偏置电压205。放大器将感应电极的电压维持到接近偏置电压的水平。心电图信号则可以通过使用附加电极进行测量。实际上,在上述通过使用各向异性粘合剂部分的增强导电性的情况下,在此同样或者替代性地,将该第三电极用作代理右腿电极(即代理右腿驱动电极)能够提供在其他不可用的情况下提供信号接收。纯净信号因此可以允许接受心脏P波,这提高了检测到无法用其他方式检测到的心律失常的概率。
电子线路的进一步的替代性说明包括图2B和2C中所示内容;其中,在所示的非限定性替代方式中,三个邻近电极E1、E2和E3可以被用于采集ECG信号,其中一个电极的作用是传统ECG监视器的远肢电极。因为电极-患者接口具有关联阻抗(Re1和Re2),所以流过该接口的电流将在患者与电极之间引起电压。电路可以使用感应电极(E1)检测患者电压。因为该典型电路节点相对于电路接地(GND)具有高阻抗,所以仅有极小的电流流过电极接口,这使得患者与该节点之间的电压降达到最小。这些替代性非限定电路中的第一个(图2B)还包括放大器(U1),放大器(U1)的低阻抗输出端被连接到单独的驱动电极(E2)上。放大器使用负反馈来控制驱动电极,以使得患者电压(感应电极E1测量的)等于偏置电压(V1)。这可以在不考虑驱动电极(E2)与患者之间的任何电压差的情况下有效地将患者电压维持为与偏置电压相等。该电压差能够包括由在驱动电极与患者(通过Re2)流动的电力线感应电流引起的电压差。该设置与传统的“右腿驱动”电路的不同之处在于以下至少两点:驱动电极被放置在患者的胸部上(而不是右腿),并且ECG信号为来自第三电极(E3)的单端(非差分)测量值。因为全部的电极都位于患者的胸部上,所以放置在患者胸部上的小型设备可以包含ECG测量所需的全部必要电极。单端测量的一个潜在有益效果是,在记录(ECG输出端)之前处理ECG信号所需的增益和滤波电子线路(U2和相关组件(图2C))需要更少的组件并且对组件容差匹配越发不敏感。图2A、2B和2C的示例是非限定示例并且不用于将权利要求的范围限制于此,本领域的技术人员根据本发明并且在本发明的精神和范围内能够形成具有其他电路元件的其他电路。
在许多实施方式中,本发明的系统可以包括可与ECG电极共同工作的其他电子线路,该电子线路因此可以伴有其他传感器以提供以下方面的时间一致轨迹:i)ECG p波、qrs波和t波;ii)使用脉搏血氧测定法测量的O2饱和度;和/或iii)xyz加速度,以提供物理活动的指数。这样的电子线路可以被实施以符合以下电规范中的一个或更多。总体系统在某些实施方式中可以包括长达两周(或更长时间)的持续运行时间,并且在此时间内收集数据。某些实施方式可以适于提供多达甚至超过1000次使用。替代方式可以包括在暴露在流体或潮湿环境下之后或期间的工作能力;在某些这样的示例中为抗水的、防水的或者耐水的;在某些情况下在完全浸没(在低盐度水中)时能够正常工作。其他实施方式可以包括快速数据传输,例如使用HS USB以在小于大约90秒的时间内传输全部数据。通常可以使用可充电电池组。
一个进一步的替代性实施方式可以包括电子“接地”:在本发明的设备中整体安装在柔性电路板上,接地层功能可以由邻近信号导线的同轴接地导线提供。该类型的接地系统的主要作用可以是允许设备具有共形且粘附到皮肤上所需的柔性。
对于心电图,EKG或ECG而言,某些实施方式可以包括大于大约10兆欧的输入阻抗;某些实施方式可以工作在0.1-48Hz的带宽下;并且某些实施方式的采样率接近256Hz;并且可以实现12位的分辨率。对于PPG和脉搏血氧测定仪,可以使用660和940nm的波长、大约80-100SpO2范围、0.05-4.8Hz带宽、16Hz采样率以及12位分辨率进行工作。对于加速计,可以使用3轴测量,并且在某些实施方式中使用±2G范围、16Hz采样率以及12位分辨率。
某些总结方法在此可以根据图3进行理解,尽管其他的总结方法可以通过并作为本发明的公开的提示进行理解。图3中的流程图300可以示范某些替代方式,其中,初始操作301可以是将设备100应用到患者身上。实际上,这可以包括上述粘合剂应用的替代方式中的某些一个或更多,要么借助于/通过使用诸如图1D中的113之类的粘合剂,要么借助于图1E、1F和/或1G中的粘合剂。则如图所示,沿着流线311移动,可以实施数据收集操作302。应当注意的是,这可以包括连续或基本连续的收集,或者间隔或周期性的收集,又或者甚至是一次事件收集。这实际上取决于所要收集的数据的类型和/或取决于其他特征或替代方式,例如,对于ECG是否想要长期的数据量,或者在脉搏血氧测定法的某些情况下相对的单个数据点是否有用(有时候,单个饱和点受到关注,例如,尽管比较数据显示出随时间的趋势,但是单个饱和点明显过低实际上更加典型)。
图3的流程图300中则存在数个替代方:第一替代方式可以沿着流线312到达数据传输操作303,数据传输操作303则可以包括从设备100到数据分析设备和/或数据存储设备和/或系统(并未在图3中单独示出,可以包括计算设备,例如参见以下所述的图4或类似方式)的无线或有线(例如,USB或其他)数据通信。这一点的选项也很明显;然而,第一替代方式可能包括沿着流线313到达数据分析操作304以分析数据,以用于确定相对健康和/或用于患者的状况诊断。计算系统,例如计算机(可以是许多类型的,手持、个人、主机或其他,参见图4和以下说明),可以被用于进行该分析;然而,如此智能的计算系统可以被整合在设备100的电子器件103,以使得可以在设备100之上或之内运行某些分析。非限定性示例,例如对于脉搏血氧测定法可以是预置比较,其中,当达到低阈值(或者在某些示例中可以是高预置)时,可以完全在设备100的电子器件103上或由其激活标识或警告。
一个类似的此类示例可以通过可选的替代性流程路径312a进行考虑,流程路径312a自身分为两个部分312b和312c。沿着流程路径312a,并且随后在第一示例路径312b中,能够意识到略过了传输数据操作303,借此在没有大量数据输送的情况下实现分析304。这可以解释板载分析,或者例如根据以上阈值示例,又或者在某些情况下根据电子器件103之上或之中整合的智能程度可以包括更详细的分析。另一视角关于即便使用传输操作303可能需要多少传输量;由于这可能包括从患者皮肤通过导体108、109和/或110通过引线107到达电子器件103以用于分析的数据传输的水平。当然,在其他示例中,传输可以包括板外下载到其他计算资源上(例如,图4)。在某些情况下,这样的数据的板外加载通过使用更高的计算能力资源可以允许或者提供更加复杂的分析。
进一步的替代方式在需要时首先可以包括数据存储。由于具有智能,所以可能出现这样的情况:某些或者并没有存储设备或存储器可用在设备100的板载电子器件103中或者由电子器件103使用。如果某些存储设备,不论是甚少还是许多存储设备可用在设备100上,则指向并通过路径312c流程路径312a可以被用于实现某些数据存储305。这可能出现在许多情况下,即便并不必须在传输或者分析之前(注意到,对于某些类型的数据可以同时并行采用多条路径,尽管这可能并不是在同一时间或者是相继进行的(例如,路径312b和312c并不需要完全彼此排斥地进行),以使得存储和传输或者存储和分析可以以以下方式发生:不需要要求任一特定操作在另一操作开始或实现之前完成)。因此,在存储305之后(或期间),流程路径315a可以紧随其后以使得存储数据可以经由路径315b传输到操作303,和/或经由路径315c传输到操作304进行分析。在这样的存储示例中,在许多情况下还可以是板载存储示例中,数据能够被收集并且随后被存储在本地存储器中,并在之后载出/传输到一个或更多用于分析的鲁棒计算资源(例如,图4)上。普遍地,这能够包括长期数据收集,例如数天或数周甚至更长,并且因此当患者离开医生办公室或者其他医疗设施时可以包括远程收集。因此,能够在患者的真实世界环境中从患者处收集数据。则在收集之后,数据能够从其设备100上的存储设备传输回到期望的计算资源(例如,图4)上,并且这样的传输可以是无线的或者有线的又或者两者的结合,正如示例中使用蓝牙或WiFi连接到个人计算机(图4中为一个示例),个人计算机则可以在互联网上将数据发送到用于最终分析的专用计算机上。另一示例可以包括USB连接到计算机上,连接到PC或主机(图4)上,并且可以是发送到患者计算机上活着发送到用于分析的医生计算机上。
如果设备100上具有很少或并没有存储设备或存储器(或者,在某些示例中,甚至可能具有大量的可用存储器),那么在收集之后的相对较短的时间之后,需要或者可能希望对数据进行传输或存储或者两者均有,参见操作303之后的路径313a,和/或对数据进行传输和分析,参见路径312和313。如果使用路径313a,那么更加典型地,数据存储可以在计算资源之中/之上(图3中未示出,但是参见下述图4)或者板外(尽管板载存储器也可以被使用),并且随后,路径315a、315b和315c中的任一个可以被使用。
本发明的一个特征包括整体系统,该系统包括一个或更多设备100以及计算资源(例如参见图4),计算资源板载在设备100上或者分离,例如在个人或移动或手持计算设备(一般由图4给出),整体系统则提供了医师或医生具有即时室内分析以及呈现所收集的测试数据的能力。在某些实施方式中,这会允许在不使用数据提取和分析的第三方的情况下由设备进行现场数据分析。
本发明的替代性实施方式因此可以包括一个或更多硬件和软件组合,以用于多种替代性数据源解释。如上所指,本发明的设备100包括的硬件对一个或更多不同生理参数进行监视,随后生成并存储代表所监视参数的相关数据。之后,诸如设备100和/或其各个部分之类的系统包括硬件和软件以及用于处理软件的计算资源(通常在图4中示出)。系统则不仅包括数据收集,而且包括数据的解释和相关。
例如,表现了高强度锻炼期间的心室心律失常的心电图迹线可以与休息时段内的相同心律失常具有不同解释。随着运动大幅变化的血氧饱和度能够指出除其他情况外比休息时严重得多的情况。四项生理参数可以具有更多组合,并且本发明的软件显示并且突出可能存在的问题的能力将极大地帮助医师的诊断。因此,本发明中所述的系统能够提供有益的数据解释。
能够有助于实现此目的某些特征可以被归入图3的操作303和304中的一个或更多,其中,在设备100上收集的数据能够更容易被发送/传输到计算资源上(同样,如图4中所示的板载设备100或其部分)。对于一个示例,当已经佩戴了设备(操作301)的患者在收集数据(操作302)的测试时段之后可以返回医师的办公室中时,设备经由一个或更多的传输替代方式,例如经由USB连接到办公室中的计算机上(Windows或Mac)(通常参照本发明的图4和说明书),从而允许在患者等待期间由医师进行即时分析(注意到设备100在传输和分析确定是否需要更多数据的过程中首先可以从患者身上取下或者可以保留在患者身上)。在某些实施方式中,数据分析时间相对较短,在某些实施方式中为大约15分钟,并且可以使用用户友好GUI(图形用户界面)实现以通过分析软件引导医师。
分析/软件包可以布置用于以各种格式向医师呈现结果。在某些实施方式中,可以呈现测试结果的概览,该概览与更加详细的结果一起或者代替更加详细的结果。在任一情况下都可以提供检测到的异常情况和/或患者触发事件的综述,该综述作为概览的一部分和/或作为更加详细的呈现的一部分。选择个别的异常情况或者患者触发事件可以提供期望的灵活性以允许医师查看额外的细节,包括来自ECG和/或其他传感器的未处理数据。这些包还可以允许采用对数据进行打印以及采用工业上的标准EHR格式与注释一起存储。
在一个实施方式中,患者数据可以使用具有一个或更多以下规范的软件进行分析。某些替代性能力可以包括:1、数据采集,即从设备上加载数据文件;2、数据格式化,即将未处理的数据格式华为工业标准文件格式(例如,aECG(xml)、DICOM或SCP-ECG)(注意,这样的数据格式化可以是采集、存储或分析的一部分,或者可以具有从一个到另一个的转换(例如,数据可以采用紧凑格式更好地存储,这可能需要进行转换或其他解包以进行分析));3、数据存储(在诊所/医疗设施上进行本地分析,或者在云端(可选地并且允许基于离线便携浏览器进行呈现/分析));4、分析,除其他情况以外,可以包括例如噪声滤波(高通/低通数字滤波);和/或,5、数据/结果呈现,有可能包括一个或更多图形用户界面(GUI),该一个或更多图形用户界面更特别地具有整体综述和/或总体统计和/或患者触发事件的异常综述,呈现出额外的细节水平:事件(前后)的血氧饱和度、压力相关性等的异常数据的条带视图,和/或允许护理人员对事件和/或打印能力的收藏/注释/注解。
进一步地,在硬件与合适的软件包的替代性组合中:i)一个设备软件包可以适于对从一个或更多的EKG/ECG上采集的数据信号的测量值(右腿和/或p波、qrs波和/或t波)、或者O2饱和度、或xyz加速度以时间一致方式进行存储,以便于医师可以访问测量值的临时历史(也就是说,在某些示例中,在1至2周的间隔),这可以提供患者在心脏时间的发生之前、期间和之后的有用信息。ii)一个替代方式替代性地对测量参数到附近基站或中继器的实时传输进行管理。和/或,iii)设备外ECG分析软件旨在识别心律失常。
上述软件可以是由第三方提供的工业默认软件,或者特别适用于从本发明的穿戴式设备100建立、传输和/或接受到的数据。在使用标准(MIT-BIH/AHA/NST)心律失常数据库的测试的整个过程中,FDA 510(k)是优选的。这样的软件可通过为ECG信号处理提供可调用功能以适于允许自动的ECG分析和解释,QRS检测和测量,QRS特征提取,正常以及心室异常突发的分类、心率测量、PR和QT间隔的测量以及节律解释。
在许多实施方式中,软件可以适于提供和/或被制作为能够提供一下测量值中的一个或更多:
表1:
1、心率最小值、最大值和平均值
2、QRS持续时间平均值
3、PR间隔平均值
4、QT间隔平均值
5、ST偏差平均值
以及,可以适于识别宽范围的心律失常,诸如以下所给出的:
表2A:
1、SINUS RHYTHM(正弦节律)
2、SINUS RHYTHM+IVCD(Inferior Vena Cave Diameter,下腔静脉直径)
3、SINUS BRADYCARDIA(正弦心动过缓)
4、SINUS BRADYCARDIA+IVCD
5、SINUS TACHYCARDIA(心动过速)
6、PAUSE(暂停)
7、UNCLASSIFIED RHYTHM(未分类节律)
8、ARTIFACT(人工)
以上第一个8种类型的分组是即便没有可辨别的P波也可以识别的心律失常类型。在我们提议强调的门诊患者监视市场中的现有产品通常可以识别这些心律失常类型。
以下的第二组或第二群心律失常可能需要可分辨且可测量的P波。本发明的某些实施方式可以适于能够检测和识别它们,这是因为设备100能够如上所述根据P波的强度来检测P波,当然并且例如,设备100的位置或患者的生理情况影响P波。
表2B:
9、ATRIAL FIBRILLATION/FLUTTER SVR(心房纤维性颤动/振颤外周血管阻力)(缓慢)
10、ATRIAL FIBRILLATION/FLUTTER CVR(正常速率)
11、ATRIAL FIBRILLATION/FLUTTER RVR(快速)
12、FIRST DEGREE AV BLOCK(一级房室传导阻滞)+SINUS RHYTHM
13、FIRST DEGREE AV BLOCK+SINUS TACHYCARDIA(正弦心动过速)
14、FIRST DEGREE AV BLOCK+SINUS BRADYCARDIA
15、SECOND DEGREE AV BLOCK(二级房室传导阻滞)
16、THIRD DEGREE AV BLOCK(三级房室传导阻滞)
17、PREMATURE ATRIAL CONTRACTION(房性期前收缩)
18、SUPRAVENTRICULAR TACHYCARDIA(室上性心动过速)
19、PREMATURE VENTRICULAR CONTRACTION(室性期前收缩)
20、VENTRICULAR COUPLET(室性联结)
21、VENTRICULAR BIGEMINY(室性二联)
22、VENTRICULAR TRIGEMINY(室性三联)
23、IDIOVENTRICULAR RHYTHM(心室自主节律)
24、VENTRICULAR TACHYCARDIA(室性心动过速)
25、SLOW VENTRICULAR TACHYCARDIA(迟缓室性心动过速)
进一步地,在替代性软件实施方式中,某些示例屏幕截图在图5中示出。第一个这样的替代方式在图5A中示出,这个示例屏幕截图是出了通过使用诸如本发明的设备100之类的小型设备获得的ECG和血氧饱和度数据。一个非常纯净的信号被示出(没有对该数据进行过滤波或平滑化)。同样示出了不同的p波(作为具有箭头的示例示出的3)。P波检测对于ECG异常情况检测是至关重要的。使用脉搏血氧测定法测量的氧饱和度在下方的曲线图中示出。这是胸部上的设备在与ECG数据一致的时间内获得的数据。
图5B中示出了另一替代方式,该替代方式是分析软件的示例屏幕截图。这是从MIT-BIH心律失常数据库记录205中获得的ECG的样本。正如本发明的系统所分析的,我们看到事件发生综述列表(左上方)的五个(5)异常情况类型(更加正常的正弦节律)。该列表还示出了每个异常情况的出现次数、整个ECG中异常情况的总时长以及整个ECG中发生该异常情况的时间比例。为了示出每个异常情况的特定情况,用户双击事件发生综述中的特定行,如图5C中所示。
如介绍一样,图5C是是出恶劣室性心动过速的特定情况的示例屏幕截图。ECG曲线图自动进入ECG波形的特定时间,并且标记出事件的开始和结束。关于该特定事件的更加详细的数据在发生细节中示出:该事件期间的HR平均值、HR最大值等等。为了示出该ECT中的另一异常情况的实例,用户能够点击事件发生综述的室性期前收缩(PVC)行,如图5D中所示。
如介绍一样,图5D是是出了室性期前收缩的特定实例的示例屏幕截图。这示出了PVC的发生。该起始时间列表(中间上部)示出了该ECG中发生的PVC的全部实例,并且列出了每次发生的起始时间。在此情况下,用户能够点击起始于00:15:27的PVC(第11次发生)。ECG曲线图自动到达该时间点以示出并指出波形中的PVC实例。因为在该时间段中存在3个实例,全部3次发生都被标记出来。
如上所述,在本发明的发展的一个方面,在脉搏血氧测定信号的同时收集的ECG信号可以被用于减小脉搏血氧测定信号中的噪声并且允许计算氧饱和度值,尤其是在生成脉搏血氧测定法数据的传感器位于患者的诸如胸部之类的噪声易发位置上的环境中。在某些实施例中,此方面可以由以下步骤实现:(a)测量多次心跳的心电图信号;(b)测量多次心跳的一个或更多脉冲血氧测定信号,以使得一个或更多心跳的心电图信号和一个或更多脉冲血氧测定信号在时间上一致;(c)将一个或更多心跳在时间上一致的心电图信号与一个或更多脉搏血氧测定信号的一部分进行比较以确定一个或更多脉搏血氧测定信号中每个的恒定分量以及主要周期分量;以及,(d)根据一个或更多脉搏血氧测定信号的恒定分量和主要周期分量确定氧饱和度。ECG信号和脉搏血氧测定信号的测量可以通过本发明的设备的实施例来实现。尤其是,脉搏血氧测定信号可以是本发明的设备中的光检测器收集的反射红外信号以及反射红光信号。心跳对应的脉搏血氧测定法的间隔可以通过将这样的信号与时间一致的ECG信号进行对比来确定。例如(并不用于限制),时间一致的ECG信号的连续R波可以被用于识别这样的间隔,尽管同样可以使用ECG信号的其他特征。一旦识别出这样的间隔,间隔内的对应时间处的值可以被平均以减小信号噪声并且获得脉搏血氧测定信号(例如,Warner等人,麻醉学,108:950-958(2008))的恒定分量(有时称为“DC分量”)和主要周期分量(有时称为“AC分量”)的更加可靠的值。在一个间隔中记录的信号值的数量取决于所使用的检测器和处理电子器件的信号采样率。同样,由于间隔的时长可以变化,所以可以对间隔中的数值子群进行平均。如下所述,氧饱和度值可以使用常规算法通过这样的DC和AC分量进行计算。如下所指,心跳的次数以及计算平均的间隔可以在很宽的范围内变化。在某些实施例中,可以对来自一个或更多心跳或间隔的信号进行分析;在其他实施例中,可以对来自多个心跳或间隔的信号进行分析;并且在某些实施例中,这样的多个心跳或间隔的范围从2至25,或者范围从5至20,或者范围从10至20。
如上所述,本发明用于实施以上方面的患者穿戴式设备对这样的测量值中的噪声区域中的氧饱和度的监视尤其有用,例如,诸如胸部位置之类的该噪声区域中具有明显的局部皮肤运动。
图6A-6C示出了本发明的以上方面的一个实施例。在图6A中,曲线A(600)示出了本发明的设备的光电二极管的红外(IR)反射随时间变化的输出,并且曲线B(602)示出了设备的光电二极管的红光反射随时间变化的输出。在某些实施例中,替代性地使用红光LED和IR LED照亮皮肤以生成由相同的光电二极管收集的信号。在图6B中,曲线C(604)示出的时间同步(即时间一致)的ECG数据被添加到图6A的曲线图中。ECG数据中的峰值(例如,峰值606和608)可以用于限定脉搏血氧测定法数据的帧或间隔。额外的连续帧或间隔由612和614指出,并且以类似方式确定进一步的帧。依照该方面,对来自多个帧的脉搏血氧测定法数据进行收集。多个帧的幅度根据特定应用可以大范围变化。在某些实施例中,收集的多个帧从5个到25个;在一个实施例中,多个帧从8个到10个帧。典型地,脉搏血氧测定法的帧或间隔包含不同数量的信号样本。也就是说,可以以预定采样率对传感器的输出采样,例如每秒钟32个样本。如果ECG峰值之间的时间变化,则每帧的样本数量将变化。在一个实施例中,ECG数据中用作一个帧的起始点的特征被选择,以使得脉搏血氧测定法数据中的关联峰值近似为该帧的中间点或中心,此后对每个帧记录预订数量的信号样本。较优地,在该实施例中,选择的预订数量足够大以保证脉搏血氧测定信号基本是中间帧。以上时间点对应的大于预订值的样本值并不使用。在收集了多个数据帧之后,对这些帧的相应时间点处的值的平均值进行计算。脉搏血氧测定法数据的AC和DC分量的这样的平均得到的值被确定并随后被用于采用常规方法计算氧饱和度,比率比算法,例如Cypress Semiconductor(塞普拉斯半导体)文件No.001-26779Rev A(2010年1月18日)。图6C的流程图中对该基本程序进行了总结。对帧大小(也就是样本的数量)进行确定(620)。每个帧内的相应时间点处的样本值相加(622),之后计算每个时间点的平均值,转而给出降噪的IR和红光反射的AC和DC分量。在某些实施例中,这些分量的值能够被用于利用常规算法计算氧饱和度(626)。氧饱和度的相对值能够通过标定特定实施例的测量值转换为绝对值。标定可以在受控环境中完成,其中,个体暴露在不断变化的大气氧浓度中,并且所测量的氧饱和度雨相应的氧水平相关。
除了以上将ECG信号与脉搏血氧测定信号进行比较的实施例以外,用于这样的比较的大量其他实施例都在本领域的技术人员的理解范围内。例如,为了在存在噪声的情况下找出脉搏血氧测定信号的AC分量的峰值,时间一致ECG信号位于脉搏血氧测定法的最大和/或最小值之前和之后的特征时间处的特征可以被用于在对多个心跳求平均的时候可靠确定脉搏血氧测定法峰值和谷值(而不需要对心跳的脉搏血氧测定信号的全部值求平均值)。例如,如果在一个间隔内,ECG信号的R波峰值在脉搏血氧测定信号的最大值之后x毫秒并且在脉搏血氧测定信号的最小值之前y毫秒,则关于脉搏血氧测定信号的AC分量的关键信息可以通过对脉搏血氧测定信号的仅两个值的重复测量来获得。
在某些实施例中,光电二极管测量到的IR或红光反射的值可以被用于估算呼吸深度。在图6D中示出了红光或IR值随时间的曲线(630)。在图6E中,曲线(630)的最大值和最小值分别由虚曲线(632)和(634)示出。一时间点处的最大值和最小值之差与被监视的个体的呼吸深度单调相关。因此如图所示,时间(636)时的呼吸比时间(638)时的呼吸更浅。在某些实施例中,可以在个体上监视并计算呼吸深度随时间的变化。
某些进一步的替代方式包括本地医学设备的数据传输和/或解释,本地医疗设施是医师或医生办公室、或者例如ICU/CCU(重症监护室/冠心病监护室)。相应地,本发明的设备100将位于患者的胸部上并且如本申请中所述使用粘合剂进行固定,该设备100将对各种生理信号中的一个或更多进行测量,这些一个或更多生理信号可以包括心电图、光电血管容积图、脉搏血氧测定法和/或患者加速度信号。设备将生理信号以无线或有线(例如,USB)方式传输到附近的基站以在需要时用于解释和进一步的传输。无线传输可以使用蓝牙、WiFi、红外线、RFID或其他无线协议。设备可以使用感应、电池组活着两者的结合进行供电。设备100监视生理信号和/或代表生理信号的数据。收集的数据则可以以无线方式或使用有线连接实时发送到附近基站。设备可以由基站或电池组无线供电,从而在患者与基站之间不需要导线。
因此,本发明的某些替代性组合可以包括以下中的一个或更多:1)选择医疗级粘合剂(具有许多可能的来源),因为这些粘合剂具有与皮肤密切接触数周(在某些示例中长达10天或者两周)但不伤害皮肤的能力,并且与不同类型的传感器一同工作;2)导电电极或光敏检测器能够提供从皮肤或从皮肤或皮下组织的光响应的电信号;3)放大器、微处理器和存储器,能够处理并存储这些电信号;4)用于本发明的电子器件的电源,具有储电活着无线接入充电能力;5)弹性电路,能够将以上元件共同绑定在能够与兴趣皮肤区域共形的柔性条带内。
被监视、记录/收集和/或分析的生理参数的示例可以包括以下中的一个或更多;心电图、用于血氧饱和度的光至激活组织的光响应;脉搏速率和相关颤动;物理活动/加速度标识。其中的一个或更多可以用在在数个昼夜中对流动的心脏病门诊患者进行监视,这借此可以提供用于记录和测试后分析的数天的连续ECG信号以及同时记录O2饱和度以及重体力活动的指数。类似地,其中的一个或更多可以被用于在数个昼夜中对流动的肺病患者进行监视,以便对O2饱和度进行记录和测试后分析,同时记录重体力活动的指数。替代性地和/或额外地,其中的一个或更多可以用于以无线方式(或者在某些情况下以有线方式)监视住院患者或在诊所、急救室或者ICU中监视其他感兴趣的患者,例如婴儿,在某些实例中检测EKG、O2和/或重体力活动的参数,但是并不存储参数,而是以无线方式将参数传输到床边监视器或者中央站监视器上,因此使患者免于附接物理导线。尤其是,本发明的设备可以被粘附到婴儿的前额以用于监视呼吸和氧饱和度。在进一步的替代方式中,本发明的设备可以被用于监视具有睡眠呼吸暂停综合征的患者的呼吸和ECG。
在此对本发明所使用的示例性计算机系统或计算资源进行说明,即便是应当注意计算系统和资源的许多替代方式在本发明的合理预见范围内都是可用且可工作的,以使得下文并非以限制方式将本发明的精神和范围内的种种可能的计算替代方式。
本发展的实施方式中的某些包括各种步骤。这些步骤中的种种步骤可以由硬件组件完成或者可以由机器可执行指令实现,机器可执行指令可以用于使具有该指令的通用处理器或专用处理器完成各个步骤。替代性地,各个步骤可以由硬件、软件和/或固件的组合来完成。如此,图4为使得可以使用本发明的实施方式的计算资源或计算机系统400的一个示例。根据本示例,这样的一个示例计算机系统400可以包括总线401、至少一个处理器402、至少一个通信端口403、主存储器404、可移除存储介质405、只读存储器406以及大量存储设备407。这些元件中或多或少可以用在本发明的特定实施方式中。
处理器402能够是任何已知的处理器,例如但并不限于,英特尔安腾或安腾2处理器、或者AMD皓龙或速龙MP处理器/或者摩托罗拉的处理器产品线。通信端口403能够是以下任一个:用于基于拨号连接的调制解调器的RS-232端口、10/100以太网端口、通用串行总线(USB)端口、或者使用铜线或光纤的Gigabit端口。通信端口403可以根据网络来选择,例如,局域网(LAN)、广域网(WAN)、或者是计算机系统400连接或者适于连接的任何网络。
主存储器404能够是随机访问存储器(RAM)、或者本领域中公知的任何其他动态存储设备。只读存储器406能够是任何静态存储设备,例如可编程只读存储器(PROM)芯片以用于存储诸如用于处理器402的指令之类的静态信息。
大量存储设备407能够被用于存储信息和指令。例如,可以使用硬盘,例如SCSI驱动的系列,光盘、硬盘阵列,例如RAID,例如RAID驱动的Adaptec系列,或者任何其他的大量存储设备。
总线401将处理器402与其他存储器、存储设备和通信块通信联接。总线401能够是根据使用的存储设备为基于PCI/PCI-X或SCSI的系统总线。
可移除存储介质405能够是以下中的任何一种:外部硬盘驱动器、软盘驱动器、Zip驱动器、CD-ROM、CD-RW、DVD-ROM。
以上所述的组件旨在对某些可能类型进行举例说明。前述示例不应当限制本发明的范围,这是因为这些示例仅为示例行实施例。
本发明的实施例尤其涉及用于监视和处理心脏参数和数据的设备、系统、方法、介质以及设置。尽管以上给出了本发明的一个或更多实施例的详细说明,但是在不超出本发明的精神的情况下,各种替代方式、变型和等效对于本领域的技术人员是显而易见的。因而,以上说明并不应理解为对本发明的范围进行限制,本发明的范围由所附权利要求书限定。
Claims (19)
1.一种用于监视生理参数的设备,所述设备用于粘附到对象的皮肤上用于生理参数监视,所述设备包括:
基板;
导电传感器,被连接到所述基板上,所述导电传感器包括代理右腿驱动电极;以及
双面复合粘合剂,具有粘合至所述对象的皮肤上的第一粘合层以及粘合至所述基板和所述导电传感器的第二粘合层,
所述第一粘合层具有彼此相邻的至少一个导电粘合剂部分以及至少一个非导电粘合剂部分,以在所述第一粘合层上形成至少一个电极区域,
所述第二粘合层为非导电性并且位于所述第一粘合层使得所述第二粘合层基本上不覆盖所述第一粘合层的所述至少一个电极区域,
所述双面复合粘合剂被附接到所述基板和所述导电传感器上;所述至少一个导电粘合剂部分被布置为与所述导电传感器导电连通接触并且适于被导电地粘附到所述对象的皮肤上以用于从所述对象到所述导电传感器的导电信号通信,
其中,所述至少一个导电粘合剂部分和所述至少一个非导电粘合剂部分的结合减少相对于皮肤的移动并且因此减小信号噪声和/或增强无噪声特性。
2.根据权利要求1所述的设备,其中,所述复合粘合剂的导电粘合剂部分被连接到各自传感器上,并且适于被基本牢固地连接到皮肤上以使得各自传感器相对于皮肤被基本固定,从而减少和/或消除可能的传感器相对于皮肤的移动。
3.根据权利要求2所述的设备,其中,所述导电粘合剂部分到所述各自传感器的连接以及到皮肤的连接消除了所述传感器相对于皮肤的移动,从而消除了噪声并提供了纯净信号。
4.根据权利要求1所述的设备,其中,所述生理参数包括用于心电图、光电容积脉搏波图、脉搏血氧测定法或对象加速度中的一个或更多或全部的一个或更多信号。
5.根据权利要求4所述的设备,其中,所述导电传感器是用于心电图的电极。
6.根据权利要求5所述的设备,其中,所述用于心电图的电极是代理右腿驱动电极。
7.根据权利要求1所述的设备,包括:
被连接到所述基板上的多个导电传感器,
具有多个导电粘合剂部分的复合粘合剂,
所述多个导电粘合剂部分被布置为与所述多个导电传感器中各自的导电传感器导电连通接触,并且适于被导电地粘附到所述对象的皮肤上以用于从所述对象到所述导电传感器的导电信号通信。
8.根据权利要求7所述的设备,其中,所述多个导电传感器包括至少一个、至少两个或至少三个用于心电图的电极。
9.根据权利要求8所述的设备,其中,所述用于心电图的电极之一是代理右腿驱动电极。
10.根据权利要求1所述的设备,所述设备适于向接收系统组件提供收集的数据和分析结果中的一个或两个。
11.根据权利要求10所述的设备,其中,收集的数据和分析结果中的一个或两个通过无线连接和有线连接中的一个或两个进行传输。
12.一种包括根据权利要求10所述的设备的系统,其中,所述接收系统组件是计算设备。
13.一种用于对对象的生理信号对应的生理数据进行收集和分析的系统,所述系统包括:
穿戴式设备,用于收集来自对象的生理数据,并且对所述生理数据进行传输和分析中的一个或两个;以及
接收系统组件,用于接收由所述设备传输的生理数据,
其中,所述穿戴式设备具有至少一个电极、所述至少一个电极所连接的基板以及复合粘合剂,所述复合粘合剂具有粘合至所述对象的皮肤上的第一粘合层以及粘合至所述基板和所述至少一个电极的第二粘合层,
所述第一粘合层具有彼此相邻的至少一个导电粘合剂部分以及至少一个非导电粘合剂部分,以在所述第一粘合层上形成至少一个电极区域,其中,所述至少一个电极区域与所述至少一个电极导电连通接触,
所述第二粘合层为非导电性并且位于所述第一粘合层使得所述第二粘合层基本上不覆盖所述第一粘合层的所述至少一个电极区域,
其中,所述至少一个导电粘合剂部分和所述至少一个非导电粘合剂部分的结合减少相对于皮肤的移动并且因此减小信号噪声和/或增强无噪声特性。
14.根据权利要求13所述的系统,其中,所述穿戴式设备包括用于对所收集的数据进行存储的板载存储器。
15.根据权利要求13所述的系统,其中,所述接收系统组件是适于对从所述穿戴式设备处接收的数据进行分析的计算设备。
16.根据权利要求13所述的系统,其中,所述穿戴式设备具有至少一个电极和电子线路,以使得所述至少一个电极起到代理右腿驱动电极的作用。
17.一种用于使用具有至少一个用于心脏监视的电极的穿戴式监视设备来降低心脏监视中的噪声的方法,所述穿戴式监视设备包括与所述至少一个电极连接的基板,所述方法包括:
将所述穿戴式监视设备用于一对象,包括以下两者:
使用具有粘合至所述对象的皮肤上的第一粘合层以及粘合至所述至少一个电极和所述基板的第二粘合层的复合粘合剂,其中,所述第一粘合层具有彼此相邻的至少一个导电粘合剂部分以及至少一个非导电粘合剂部分,以在所述第一粘合层上形成至少一个电极区域,所述第二粘合层为非导电性并且位于所述第一粘合层使得所述第二粘合层基本上不覆盖所述第一粘合层的所述至少一个电极区域;其中,所述至少一个电极区域与所述至少一个电极导电连通接触以及
使用适用于所述至少一个电极的电子线路以使所述至少一个电极充当代理右腿驱动电极;
收集代表生理信号的数据;
分析所述数据,
其中,所述至少一个导电粘合剂部分和所述至少一个非导电粘合剂部分的结合减少相对于皮肤的移动并且因此减小信号噪声和/或增强无噪声特性。
18.根据权利要求17所述的方法,进一步包括:
传输来自所述穿戴式监视设备的数据。
19.根据权利要求17所述的方法,进一步包括:
传输来自所述穿戴式监视设备的数据;以及
在进行所述数据的传输和分析之一或两者之前存储所述数据。
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