CN102740766B - 用于生理监测的具有电子设备的身体粘附贴片 - Google Patents

用于生理监测的具有电子设备的身体粘附贴片 Download PDF

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CN102740766B
CN102740766B CN201080062953.0A CN201080062953A CN102740766B CN 102740766 B CN102740766 B CN 102740766B CN 201080062953 A CN201080062953 A CN 201080062953A CN 102740766 B CN102740766 B CN 102740766B
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CN102740766A (zh
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S·T·马萨尔
S·斯瓦米纳坦
J·恩格尔
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Medtronic Monitoring Inc
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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
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/251—Means for maintaining electrode contact with the body
    • A61B5/257—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/251—Means for maintaining electrode contact with the body
    • A61B5/257—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
    • A61B5/259—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes using conductive adhesive means, e.g. gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/282—Holders for multiple electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/333—Recording apparatus specially adapted therefor
    • A61B5/335—Recording apparatus specially adapted therefor using integrated circuit memory devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
    • A61B2560/0412—Low-profile patch shaped housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A61B5/0006—ECG or EEG signals
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49002—Electrical device making
    • Y10T29/49117—Conductor or circuit manufacturing

Abstract

在一种配置中，一种用于粘附到一个受试者的皮肤上的粘附装置包括一个可伸展基底层，该基底层具有一个上侧面和一个下侧面以及在该下侧面上将该基底层粘附到受试者的皮肤上的一个粘合剂涂层。该基底层具有至少两个延伸穿过的开口，这至少两个开口中的每个都具有一个尺寸。该粘附装置还包括一个可伸展覆盖层，定位于该基底层之上并且用一种粘合剂粘附到其上以限定至少两个口袋。该粘附装置还包括：至少两个凝胶体，每个凝胶体具有比开口的尺寸更大的尺寸，以将该凝胶体基本上保持在该口袋内；以及用该可伸展基底层支撑以测量受试者的至少一个生理信号的一个电路载体。还要求了其他的配置和方法。

Description

用于生理监测的具有电子设备的身体粘附贴片
本申请要求2009年12月14日申请的标题为“用于生理监测的具有电子设备的身体粘附贴片（BodyAdherentPatchwithElectronicsforPhysiologicMonitoring）”的美国临时专利申请号61/286,075的优先权，特此将其全部披露内容出于所有目的在此通过引用进行结合。
发明背景
1.发明领域
本发明涉及生理监测和/或治疗。虽然实施方案具体提及用粘附装置监测阻抗和心电图信号，但在此所述的这些系统方法和装置可以应用于许多应用中，其中使用生理监测和/或治疗持续延长的时段，例如使用无线生理监测持续延长的时段。
经常针对与患者的受损状态（例如受损生理状态）相关联的疾病和/或病症而对患者进行治疗。在一些情况下，患者可能会报告需要诊断来确定根本原因的症状。例如，患者可能会报告需要诊断的昏晕或眩晕，其中患者的长期监测可以提供关于患者生理状态的有用信息。在一些情况下，患者可能已遭受心脏病发作并且在离开医院之后需要护理和/或监测。提供对患者长期监测的装置的一个实例是霍尔特监护仪（Holtermonitor），或动态心电图装置。
除了用心电图测量心脏信号之外，已知的生理测量包括阻抗测量。例如，可以用经胸阻抗测量来测量水合和呼吸。虽然经胸测量可以是有用的，但是这些测量可能使用穿过患者中线而被定位的电极，并且患者佩戴可能有点不舒适和/或麻烦。在至少一些情况下，保持在患者皮肤上的电极可能变得分离和/或脱水，使得必须更换电极，由此使长期监测更加困难。
有关本发明实施方案的操作表明，已知的用于长期监测患者的方法和器械可能是较不理想的。至少在一些情况下，患者佩戴的装置可能有点不舒适。虽然用粘合剂将测量电极和测量电路粘附到皮肤上的装置可以提供改善的舒适度，有关本发明实施方案的操作表明这些装置的粘合剂可以更快地从患者的皮肤分离将会是理想的。当前装置的这些限制可以导致患者至少在一些情况下不会像理想中那么长时间地佩戴这些装置并且不遵从卫生保健提供者的指导，从而使得收集到的数据可能较不理想。
类似的困难可以发生在其他受试者的监测中，例如在非医疗环境中的人，或发生在动物的监测中，如兽医、农业或野生动物监测。因此，对于改进的受试者监测存在着需要。理想地，这样的改进的受试者监测将会避免目前方法和装置的至少一些缺点。理想地，这些改进的装置将允许用粘合剂将粘附装置粘附到受试者的皮肤上，以便将伴随的电子设备舒适地携带在受试者的皮肤上持续一个延长的时段。
2.背景技术说明
以下美国专利和公开物可以描述有关背景技术：美国专利号3,170,459、3,805,769、3,845,757、3,972,329、4,141,366、4,522,211、4,669,480、4,838,273、5,133,355、5,150,708、5,450,845、5,511,533、5,607,454、6,141,575、6,198,955、6,327,487、6,795,722、7,395,106、2004/0006279、2004/0015058、2006/0264730、2007/0106132、2007/0208262、2007/0249946、2007/0255184、2008/0171929、2007/0276273、以及2009/0182204。
发明概述
在许多实施方案中，要粘附到受试者皮肤的粘附装置包括一个可伸展基底层，该基底层具有一个上侧面和一个下侧面以及一个在该下侧面上将该基底层粘附到受试者皮肤上的粘合剂涂层。该基底层具有至少两个延伸穿过的开口，这至少两个开口中的每个都具有一个尺寸。该粘附装置还包括一个定位在基底层之上并且用粘合剂粘附到基底层以限定至少两个口袋的可伸展覆盖层，以及至少两个凝胶体，每个凝胶体具有比该至少两个开口的尺寸更大的尺寸以将所述凝胶体基本上保持在所述口袋内。该粘附装置进一步包括一个用可伸展基底层支撑的电路载体以测量受试者的至少一个生理信号。受试者可以包括人、运动员、患者或动物如驯养或野生动物。
根据一些实施方案，监测具有皮肤的受试者的粘附装置包括一个可伸展基底层，该基底层具有一个上侧面和一个下侧面以及一个布置在该下侧面上将基底层粘附到受试者皮肤上的粘合剂涂层。该基底层具有至少两个延伸穿过的开口，每个开口都具有一个尺寸。该粘附装置进一步包括一个具有布置在其上的至少两个电极的柔性电路支撑物，每个电极用至少两个开口的对应一个开口定位，以耦合到受试者的皮肤上。用基底层中的至少两个开口来定位至少两个凝胶体，每个凝胶体具有比所述每个开口的尺寸更大的尺寸。该装置还包括一个定位在至少两个凝胶体上并且粘附到基底层上的可伸展覆盖层，使得每个凝胶体基本上被限制在布置在基底层与覆盖层之间的相应口袋之内。该粘附装置进一步包括保持电子元件的电路载体，用柔性电路支撑物电连接到该至少一个电极上，以测量受试者的至少一个生理信号。
在一些实施方案中，每个凝胶体和每个口袋的尺寸被确定为大于可伸展基底层的相应开口，以便当可伸展基底层粘附到受试者皮肤上时将所述凝胶体保持在所述口袋中。在一些实施方案中，可伸展基底层包括一个薄的柔性的可伸展基底层，以随着受试者皮肤伸展并且贴合受试者皮肤的褶皱。在一些实施方案中，可伸展覆盖层包括一个薄的柔性的可伸展覆盖层，以随着受试者皮肤伸展并且贴合受试者皮肤的褶皱。粘附装置可以进一步包括布置在覆盖层之上并且粘附到其上的一个薄的柔性的可伸展上覆层。该上覆层可以由机织织物制成。
在一些实施方案中，该粘附装置进一步包括一个加强结构，该加强结构布置在基底层和覆盖层的共同周边上方并且耦合到其上并且被配置为加强基底层和覆盖层的周边边缘。该加强结构可以被配置为在粘附装置粘附到受试者之后可移除。在一些实施方案中，该粘附装置进一步包括布置在覆盖层之上并且粘附到其上的一个薄的柔性的可伸展上覆层，并且该加强结构布置在基底层和覆盖层以及该上覆层的共同周边上方并且耦合到其上，并且该加强结构被配置为加强基底层和覆盖层以及该上覆层的周边边缘。根据这些实施方案的粘附装置可以进一步包括布置在电路载体上方并且在一个共同周边处耦合到基底层和覆盖层上的一个软的柔性覆盖物。该覆盖物可以包括一种材料，该材料被配置为阻止液体到达电子元件。该覆盖物的周边可以布置在该加强结构的下面。在一些实施方案中，该柔性电路被配置为可伸展的。
在一些实施方案中，该柔性电路是由基本上不可伸展的材料形成的，并且在几何上被配置为可伸展的。在一些实施方案中，该柔性电路包括一个聚酯基底和由银导电墨形成的迹线。该柔性电路可包括一个S形。该柔性电路可以被布置在基底层与覆盖层之间。
在一些实施方案中，该粘附装置进一步包括在电路载体与基底层之间的一个顺应性连接件（compliantconnection）。在一些实施方案中，基底层和覆盖层的结合是透气的。基底层和覆盖层的结合可以具有至少100g/m2/天的湿气蒸发传输率。
根据一些实施方案，粘附装置包括一个薄的柔性可伸展基底层，该基底层具有一个上侧面和一个下侧面以及在该下侧面上的一个粘合剂涂层。至少一个电极粘被附着到基底层上并且能够电耦合到受试者的皮肤上。柔性电路被连接到该至少一个电极上，并且保持电子元件的一个电路载体经由该柔性电路电连接到该至少一个电极上并且被配置为测量受试者的至少一个生理信号。该粘附装置进一步包括布置在基底层周边上方并且耦合到其周边上的加强结构，并且该加强结构被配置为加强基底层的周边边缘。在一些实施方案中，该加强结构被配置为当粘附装置粘附到受试者上时可将其移除。该加强结构可由乙烯薄片制成。
在一些实施方案中，粘附装置进一步包括布置在基底层上方并且粘附到其上的一个薄的柔性的可伸展上覆层，并且该加强结构被布置在该基底层和该上覆层的共同周边上方并且耦合到其上，并且该加强结构被配置为加强该基底层和该上覆层的周边边缘。根据一些实施方案，该粘附装置进一步包括在每个电极下面的凝胶贴片，并且每个凝胶贴片提高在对应电极与受试者皮肤之间的电导率。该柔性电路被配置为可伸展的。
在一些实施方案中，该粘附装置进一步包括布置在电路载体上方并且耦合在该基底层的周边处的一个软的柔性覆盖物。该覆盖物可以包括一种材料，该材料被配置为阻止液体到达电子元件。基底层的下侧面被配置为粘附到受试者的皮肤上。
在一些实施方案中，该粘附装置进一步包括粘附到基底层的下侧面的一个薄的柔性的可伸展底层，该底层被配置为粘附到受试者的皮肤上。基底层和底层的结合可以是透气的。基底层和底层的结合可具有至少100g/m2/天的湿气蒸发传输率。
在一些实施方案中，该粘附装置进一步包括在每个电极下面的一个凝胶贴片，并且每个凝胶贴片提高对应电极与受试者皮肤之间的电导率，并且每个凝胶贴片的周边被夹在基底层与底层之间。在一些实施方案中，该底层包括至少一个开口，至少一个电极与受试者皮肤之间的电接触通过该开口得以实现。该粘附装置可以进一步包括在电路载体与基底层之间的顺应性连接件。
根据一些实施方案，粘附装置包括一个薄的柔性可伸展基底层，该基底层具有一个上侧面和一个下侧面以及在该下侧面上的一个粘合剂涂层。至少一个电极被附着到基底层上并且能够电耦合到受试者的皮肤上。一个柔性电路被连接到该至少一个电极上，并且被配置为伸展。该粘附装置进一步包括一个保持电子元件的电路载体，经由柔性电路而电连接到该至少一个电极上，并且被配置为测量受试者的至少一个生理信号。
在一些实施方案中，该柔性电路由基本上不可伸展的材料形成，并且在几何上被配置为可伸展的。在一些实施方案中，该柔性电路包括一个聚酯基底和由银导电墨形成的迹线。该柔性电路可包括一个S形。该柔性电路可包括一个锯齿形。
在一些实施方案中，该粘附装置进一步包括在每个电极下面的凝胶贴片，并且每个凝胶贴片提高在其对应电极与受试者皮肤之间的电导率。在一些实施方案中，该基底层被配置为粘附到受试者的皮肤上，并且粘附装置进一步包括被布置在基底层之上并且粘附到其上的一个薄的柔性的可伸展上覆层。在一些实施方案中，该粘附装置进一步包括被布置在基底层下方并且粘附到基底层上的一个薄的柔性的可伸展底层，并且该底层被配置为粘附到受试者的皮肤上。在一些实施方案中，该粘附装置进一步包括被布置在基底层周边上方并且耦合到其上的加强结构，并且该加强结构被配置为加强基底层的周边边缘。该粘附装置可以包括在电路载体与基底层之间的顺应性连接件。
根据一些实施方案，监测具有皮肤的受试者的粘附装置包括一个可伸展基底层，该基底层具有一个上侧面和一个下侧面以及一个在该下侧面上将基底层粘附到受试者皮肤上的粘合剂涂层。该基底层具有至少两个延伸穿过的开口，这至少两个开口的每个都具有一个尺寸。可伸展覆盖层被定位于基底层之上并且用粘合剂粘附到其上以限定至少两个口袋。该粘附装置进一步包括柔性电路支撑物，该电路支撑物包括第一部分和第二部分，该支撑物的第一部分粘附在可伸展基底层与可伸展覆盖层之间，第二部分从第一部分延伸。至少两个电极被布置在柔性电路支撑物的第一部分上。该粘附装置进一步包括至少两个凝胶体，并且每个凝胶体和每个电极被定位在相应的口袋之内，每个凝胶体具有比对应开口的尺寸更大的尺寸，以将所述凝胶体基本上保持在基底层与覆盖层之间的所述口袋之内。该粘附装置进一步包括用可伸展基底层来支撑的电路载体，当可伸展基底层随着受试者皮肤伸展时，保持电子元件的该电路载体用柔性电路支撑物的第二部分电连接到该至少两个电极上，以便缓解张力，这些电子元件被配置为测量受试者的至少一个生理信号。
根据一些实施方案，一种制造要粘附到受试者皮肤上的粘附装置的方法包括提供一个可伸展基底层，该基底层具有一个上侧面和一个下侧面以及一个在该下侧面上将基底层粘附到受试者皮肤上的粘合剂涂层。该基底层具有至少两个延伸穿过的开口，这至少两个开口的每个都具有一个尺寸。该方法进一步包括：提供一种柔性电路支撑物，在其上布置有至少两个电极和多个导电材料迹线；提供至少两个凝胶体；并且提供一个可伸展覆盖层。该方法进一步包括：将该柔性电路支撑物和至少两个凝胶体定位在可伸展基底层与可伸展覆盖层之间，并且将可伸展基底层粘附到可伸展覆盖层上以形成至少两个口袋，其中每个口袋具有布置在其中的该至少两个凝胶体中的一个和这些电极中的一个。该方法还包括用柔性电路支撑物将电路载体耦合到该至少两个电极上。
根据一些实施方案，监测具有皮肤的患者的方法包括将附着到可伸展覆盖层上的可伸展基底层粘附到患者的皮肤上。该可伸展基底层和该可伸展覆盖层限定了布置在其中的具有凝胶体和电极的多个口袋，并且这些电极用布置在口袋中的凝胶体耦合到皮肤上。该方法进一步包括测量来自这些电极的信号以监测患者。
根据一些实施方案，粘附到受试者皮肤的粘附装置包括用于粘附到受试者皮肤上的装置，以及耦合到该用于粘附的装置以测量受试者的至少一个生理信号的电路载体装置。
还描述和要求了其他实施方案。
附图简要说明
图1显示了包括根据本发明实施方案的粘附装置的一个患者和一个监测系统。
图2A显示了根据本发明实施方案的如在图1中的粘附装置的部分分解透视图。
图2B展示了根据本发明实施方案的支撑贴片的分解图。
图2C显示了图2B的支撑贴片的底视图。
图3显示了根据本发明实施方案的被配置为可伸展的柔性电路。
图4展示了根据本发明实施方案的在电路载体与基底层之间的顺应性连接件。
图5展示了根据本发明的另外的实施方案的粘附装置的分解图。
图6展示了根据本发明的另外的实施方案的粘附装置的分解斜视图。
发明详细说明
本发明的实施方案涉及受试者监测和/或治疗。虽然实施方案具体提及用粘附装置监测阻抗和心电图信号，但在此所述的这些系统方法和装置可以应用于许多应用中，其中使用生理监测和/或治疗持续延长的时段，例如使用无线生理监测持续延长的时段。
本发明的实施方案可能特别适合于与包括一个支撑物的粘附装置一起使用，例如可以包括可伸展带子的贴片，使得该支撑物可被配置为粘附到受试者上并且将电子设备和传感器支撑在受试者上。该支撑物也可以是多孔的和透气的，从而允许水蒸气传输，例如像美国专利公开号2009/0076363所描述，其全部披露内容通过引用结合在此并且适用于根据在此所述的本发明的一些实施方案的组合。该粘附装置可以包括一个覆盖物和多个电子元件，这些电子元件被布置在耦合到该支撑物上以提供张力缓解的载体上，使得该支撑物可以随着受试者的皮肤而伸展和弯曲。在此所述的实施方案对于当支撑物伸展和弯曲时抑制电子设备电路载体的运动是特别有用的，从而减少可能导致脱落的支撑物的局部负载。当力局限在粘附装置边缘附近时，例如当载体倚靠着覆盖物移动时，局部的力可导致边缘附近脱落，并且在此所述的实施方案可以用一种抑制载体相对于支撑物移动并且还允许支撑物伸展的顺应性结构来抑制这样的局部力。
图1所示为一个实例受试者，患者Ｐ，以及一个监测系统10。患者P包括中线M、第一侧面S1，例如右侧面，以及第二侧面S2，例如左侧面。监测系统10包括粘附装置100。粘附装置100可在许多位置粘附到患者P，例如患者P的胸廓T或臂A。在许多实施方案中，粘附装置可粘附到患者的一个侧面上，可从该侧面收集数据。有关本发明实施方案的操作表明，在患者侧面上的定位可以为患者提供舒适感，同时将该装置粘附到患者上。
监测系统10包括用来传输数据到远程中心106的元件。远程中心106可以位于距离受试者例如患者P的不同建筑物中，例如与受试者在同一个市镇中，并且可以位于像距离受试者的分开的大陆的受试者那样远，例如受试者位于第一大陆上，而远程中心位于第二大陆上。粘附装置100可无线地向中间装置102进行通信，例如使用从受试者上的粘附装置到中间装置的单个无线跳跃（singlewirelesshop）。中间装置102可用许多方式与远程中心106进行通信，例如用因特网连接和/或用蜂窝连接。在许多实施方案中，监测系统10包括一个分布式处理系统，此系统中具有至少一个在装置100上的包括有形介质的处理器，至少一个在中间装置102上的处理器，以及至少一个在远程中心106上的处理器106P，这些处理器中的每个都可与其他处理器进行电子通信。至少一个处理器102P包括一种有形介质102T，并且至少一个处理器106P包括一种有形介质106T。远程处理器106P可包括位于远程中心上的后端服务器。远程中心106可以用通信系统107A（例如因特网、内联网、电话线、无线和/或卫星电话）与卫生保健提供者108A进行通信。卫生保健提供者108A，例如家庭成员，可以用通信例如双向通信系统系统（例如通过手机、电子邮件、陆上通讯线）来与患者P进行通信，如箭头109A所指示。远程中心106可以用通信系统107B（例如因特网、内联网、电话线、无线和/或卫星电话）来与卫生保健专业人员（例如医生108B）进行通信。医生108B可以用通信例如双向通信系统（例如通过手机、电子邮件、陆上通讯线）来与患者P进行通信，如箭头109B所指示。远程中心106可以用通信系统107C（例如因特网、内联网、电话线、无线和/或卫星电话）来与紧急情况应答者108C（例如911接线员和/或急救医士）进行通信。紧急情况应答者108C可如箭头109C所指示而移动到患者处。因此，在许多实施方案中，监测系统10包括一个闭环系统，在所述闭环系统中，响应于来自粘附装置的信号，可以从远程中心监测和实施患者护理。
在许多实施方案中，粘附装置可连续地监测生理参数、无线地与远程中心进行通信并且在必要时提供警报。该系统可包括一个粘附贴片，该粘附贴片粘附到受试者的胸廓上并且包含感知电极、电池、存储器、逻辑以及无线通信能力。在一些实施方案中，该装置可以经由在受试者家里的中间装置而与远程中心进行通信。在一些实施方案中，远程中心106接收患者数据并且实施患者评估和/或预测算法。当旗标升起时，该中心可与患者、医院、护士和/或医生进行通信以允许治疗性干预，例如为防止代偿失调。
在许多实施方案中，粘附装置可以包括具有可更换贴片的可再使用的电子设备模块，并且每个可更换的贴片可以包括一个电池。该模块可以收集累积数据持续大约90天，和/或者全部粘附元件（电子设备＋贴片）可以是一次性的。在完全一次性的实施方案中，可以使用“指挥棒”（baton）机制来进行数据传送和保持，例如指挥棒传送可以包括基线信息。在一些实施方案中，该装置可以具有可再充电的模块，并且可以使用双电池和/或电子设备模块，其中一个模块101Ａ可以使用充电站103来再充电，而另一个模块101B用连接器而置于粘附贴片上。在一些实施方案中，中间装置102可以包括充电模块、数据传送、存储和/或传输，使得一个电子设备模块可以被置于中间装置中用于充电和/或数据传送，而另一个电子设备模块由受试者佩戴。
系统10可以执行以下功能：起始、编程、测量、存储、分析、通信、预测和显示。该粘附装置可以含有以下生理传感器的子集：生物阻抗、呼吸、呼吸率变异性、心率（平均、最小、最大）、心脏节律、心率变异性（以下称为“HRV”）、心率震荡（以下称为“HRT”）、心音（例如S3）、呼吸音、血压、活力、体位、觉醒/睡眠、端坐呼吸、温度/热通量以及体重。活动传感器可包括以下的一种或多种：滚珠开关（ballswitch）、加速度计、每分通气量、HR、生物阻抗噪声、皮肤温度/热通量、BP、肌肉噪声、体位。关于使用粘附贴片来测量特定生物信号的另外的细节可以可共同未决的美国专利申请12/209,273（公开号2009/0076363）和12/209,288（公开号2009/0076345）中找到，两者都在2008年9月12日提交并且名称为“具有多个生理传感器的粘附装置（AdherentDevicewithMultiplePhysiologicSensors）”。
粘附装置可无线地与远程中心106进行通信。该通信可以直接发生（经由蜂窝网络或Wi-Fi网络），或通过中间装置102间接发生。中间装置102可以由多个装置组成，所述多个装置可以有线地104或无线地进行通信以将数据中继到远程中心106。
在许多实施方案中，指令从远程地点106传输到用受试者上的粘附贴片来支撑的处理器中，并且用受试者支撑的该处理器可以接收更新的指令以用于受试者治疗和/或监测，例如当由受试者佩戴时。
为了由系统10收集完整并且可靠的数据，并且为了最佳受试者舒适度，所希望的是粘附装置100保持紧固地附接到受试者上持续一个预定时间段，例如一周或两周或更长时间。如果粘附装置100过早地被移走，使得一个或多个感知电极不再与受试者的皮肤保持紧密接触，则有价值的医疗或其他数据可能会丢失。例如，被移走的粘附装置100也可能需要更换，从而导致患者不舒适、对于医务人员的不方便以及不需要的费用。
已经注意到了各种粘附失败机制。正常的受试者活动可以导致粘附装置100的伸展、隆起、推撞或另外地以趋向于给与受试者皮肤粘合接点处施压的方式移动。这尤其对于长时间佩戴的粘附装置可能是真实的，在佩戴期间受试者可能希望从事正常活动，包括锻炼、沐浴等。支撑贴片的边缘可能尤其倾向于从皮肤分离，并且可能形成湿气进入的途径，这可以加速粘附装置与皮肤之间的粘附接合的恶化。由于所希望的是将新的特征和性能增加到装置例如粘附装置100中，保持紧固接合到受试者皮肤上的困难可能进一步加剧。例如，为了延长粘附装置100的使用寿命或提供复杂的特征，和先前的设计相比，可能所希望的是包括具有相当重量的电池，以及另外的电子设备或包装。电池和电子设备的合并重量可以多达60克或更多，使得此单元的推撞可以将重大的惯性负载传递至与受试者皮肤的接合上。此外，粘附装置的位置可以影响与受试者皮肤的粘附接合的耐久性。例如，可以通过置于患者的左锁骨和左乳头之间的装置来获得尤其有用的心电图读数。然而，这个区域也倾向于伸展，并且可能表现为难以进行长期粘附的部位。即使使用了替代性的部位，例如沿着患者的肋骨线，但是增强的粘附耐久性是所希望的。
除了以上描述的医疗环境之外，本发明的实施方案还可以用于非医疗环境中，以及用于除了人类医疗患者之外的其他受试者。例如，根据本发明实施方案的粘附装置可用来监测运动员在锻炼期间的心率或其他数据。在另一种环境中，根据本发明实施方案的粘附装置可用来监测动物，以用于农业研究、兽医医疗测试或治疗，或其他目的。出于本披露的目的，受试者是根据本发明的实施方案的粘附装置可以出于任何目的而粘附到其上的任何人或动物。虽然在此描述了关于医疗患者的监测或治疗的粘附装置的某些实例使用，但是所附的权利要求书并不局限于此。不管什么环境或受试者，和现有的粘附装置相比较，本发明的实施方案提供了在粘附装置与受试者皮肤之间的粘附接合的改进的耐久性。
图2A显示了根据本发明实施方案的如图1中的粘附装置100的部分分解透视图。粘附装置100包括一个支撑贴片201，该支撑贴片201可以进一步包括一个基底层202和一个覆盖层203。基底层202是可伸展的，并且具有上侧面204和下侧面205，以及一个在下侧面205上将基底层202粘附到受试者的皮肤上的粘合剂涂层。覆盖层203也是可伸展的，并且被定位在基底层202之上并且粘附到其上。图2B展示了根据本发明实施方案的支撑贴片201的分解图。如在图2Ｂ中最佳地看到的，柔性电路206包括至少两个电极，例如电极207A、207B、207C和207D，这些电极在使用期间与受试者的皮肤处于电接触。柔性电路206有时也可称为柔性电路支撑物。柔性电路206将电极207A、207B、207C和207D电连接到保持电子元件209的电路载体208上，电子元件209被配置为测量受试者的至少一个生理信号。电子元件209可包括一个天线210，使得粘附装置100可传送它的读数以用于远程监测。电路载体208可以通过任何合适的装置而机械地连接到基底层202上并且由其支撑，这些装置包括以下更详细讨论的那些。
粘附装置100可以进一步包括配合在电子元件209之上的壳体211，从而为电子元件209提供保护、隔绝和缓冲.壳体211可以进一步包含用于容纳电池212的部件。壳体211可以由例如软的硅酮橡胶制成。在其他实施方案中，壳体211可以包括在电子元件209与电路载体208之上的密封剂（encapsulant）。壳体211可以为电子元件209提供免于湿气的保护。
粘附装置100还可以包括粘附到支撑贴片201上的覆盖物213。覆盖物213可以包括任何已知的生物相容的覆盖物、套管和/或壳体材料，例如弹性体，如硅酮。弹性体可以是有孔的，以提高透气性。在一些实施方案中，覆盖物213可以包括其他透气性材料，例如包括聚酯、聚酰胺、尼龙和/或弹性纤维（斯潘德克斯弹性纤维（Spandex）TM）的布料。透气性织物可以被涂覆或以其他方式被配置为使其耐水、防水，例如帮助芯吸湿气离开贴片，或阻止液体到达电子元件209。
虽然粘附装置100被显示为大体上是长方形的并且具有其宽度的大约两到三倍的长度，但这不是必要条件。本领域的技术人员将认识到其他形状对于根据本发明的实施方案的粘附装置是可能的。例如，支撑贴片201可以是圆形、椭圆形或长度只稍微大于宽度的长方形、正方形、矩形或某其他形状。并且虽然电极207A、207B、207C和207D被展示为线性安排，这也不是必要条件。本领域的技术人员将认识到的是，可以按任何适合于粘附装置100的预期用途的模式来安排电极207A、207B、207C和207D，包括用圆形、长方形、正方形、矩形或其他模式。
再参考图2Ｂ，基底层202包括至少两个开口，在这种情况下有四个开口215A、215B、215C和215D，每个开口对应于电极207A、207B、207C和207D之一。每个开口都具有一定的尺寸。凝胶体214A、214B、214C和214D被置于开口处，在基底层202与覆盖层203之间。每个凝胶体214A、214B、214C和214D包括提高在对应电极与受试者皮肤之间的电导率的导电凝胶体材料的水凝胶贴片。例如，凝胶体214A、214B、214C和214D可以由水凝胶粘合剂9880（可从美国明尼苏达州圣保罗的3M公司获得）或另一种适合的材料制成。
每个凝胶体214A、214B、214C和214D大于对应开口215A、215B、215C或215D，使得当覆盖层203和基底层202粘附到一起时，在每个开口215A、215B、215C和215D上方形成一个口袋，其中凝胶体214A、214B、214C和214D之一被保持在每个对应口袋中。
优选地，基底层202、覆盖层203或两者都是薄的、柔性的并且可伸展的，以随着受试者皮肤伸展并且贴合受试者皮肤的褶皱。例如，这些层的任何两者之一或两者可以由可从美国加利福尼亚州帕萨迪纳的艾利丹尼森公司（AveryDennisonCorporation）获得的MED5021聚氨酯薄膜或可从美国明尼苏达州圣保罗的3M公司获得的TegadermTM膜制成。可以使用其他适合的材料。
在一些实施方案中，支撑贴片201可以进一步包括布置在覆盖层203之上并且粘附到其上的上覆层216。上覆层216也优选是薄的、柔性的并且可伸展的。例如，上覆层216可以由机织织物制成。
再参考图2A，凝胶体214A、214B、214C和214D优选地被置于覆盖层203（和上覆层216，如果存在的话）下面。柔性电路206也可以被定位在覆盖层203下面，如在图2B中的柔性电路206的一部分的虚线描绘所指示。凝胶体214A、214B、214C和214D因此可以被保持在基底层202与覆盖层203之间的口袋中。
粘附装置100可进一步包括加强结构，例如在图2A中所示的加强结构217。在本实例实施方案中，加强结构217被配置为在覆盖物213的外部区域218处粘附到覆盖物213的顶部。装配好以后，加强结构217然后被耦合到基底层和覆盖层的共同周边，使得基底层和覆盖层的周边边缘被加强，例如以防止基底层202的下侧面205卷曲或不经意地粘附到自身上。加强结构217可由比用于基底贴片201中的材料更硬的材料做成，但是仍然足够顺应以当该贴片粘附到受试者的皮肤时使基底贴片201贴合皮肤。例如，加强结构217可以由乙烯薄片制成。加强结构217也可以被配置为在粘附装置100粘附到受试者皮肤之后可移除。例如，加强结构217可以包括粘合剂，该粘合剂被配置为在将粘附装置100施用于受试者期间将加强结构217保持在适当位置，但是容易释放，而不会将粘附装置100从受试者皮肤移去。这样，加强结构217可以帮助实现将粘附装置100紧密地粘附到受试者上，但是当粘附装置100被佩戴时不妨碍支撑贴片201贴合受试者皮肤的皱纹、褶皱和其他移动的能力。
图2C显示了支撑贴片201的底视图，其中基底层202的底部下侧面205是可见的。开口215A、215B、215C和215D、凝胶体214A、214B、214C和214D的暴露部分也是可见的。凝胶体214A、214B、214C和214D的其他部分在基底层202的后面，在形成于基底层202与覆盖层203之间的口袋中。
在一些实施方案中，柔性电路206可以由柔性材料如聚酰亚胺、聚酯或另一种基底材料制成，具有形成于基底材料中或其上的电路迹线。例如，这些电路迹线可以由铜、铜合金、银墨或其他导电材料做成。在一个优选的实施方案中，柔性电路206包括聚酯基底和由银导电墨形成的迹线。在一些实施方案中，柔性电路206可以被配置为可伸展的，而且是柔性的。即使柔性电路206的材料不是固有地可伸展的，但是可以通过适当地配置它的几何形状而使该柔性电路有效地可伸展。例如，柔性电路206中的至少与支撑贴片201接触的部分可以具有S形，允许支撑贴片201伸展并使自身贴合到粘附装置100粘附到其上的受试者皮肤上，而不过度地被柔性电路206限制。在图3中显示了具有这种特征的柔性电路206A。还可以使用其他配置。例如，柔性电路206A可以具有锯齿形，或使柔性电路206A可伸展的另一种形状。
如先前所提到的，电路载体208可以具有到基底层202的顺应性连接件。在图4中展示了一种示例性的顺应性连接件。在此连接件中，桥接环401A、401B、401C和401D从支撑贴片201（包括基底层202）连接到电路载体208。例如，环401A、401B、401C和401D可以例如由塑料增强纸、塑料膜、织物、金属或任何其他适合的材料制成。优选地，环401A、401B、401C和401D允许电路载体208围绕在图4中展示的X和Y轴相对自由地旋转，但是限制电路载体208围绕Z轴旋转。由于每个环401A、401B、401C和401D在支撑贴片201的内部部分402而不是在支撑贴片201的外部部分403连接到支撑贴片201上，施加到支撑贴片201上的负载趋向于不妨碍支撑贴片201的易损周边，在该周边处尤其可能开始从受试者皮肤的分离。更多关于电路载体208与基底层202之间的顺应性连接件的细节可以在2009年9月11日提交的名称为“用于生物监测的粘附贴片中的电子设备集成（ElectronicsIntegrationinAdherentPatchforPhysiologicMonitoring）”共同未决的美国临时专利申请61/241,713中找到，出于所有目的将其全部披露内容特此进行结合。
在一些实施方案中，基底层202、覆盖层203或者它们的结合可以是透气的。例如，基底层202和覆盖层203的结合可以具有至少100g/m2/天的湿气蒸发传输率。
图5展示了根据本发明的另外的实施方案的粘附装置500的分解图。粘附装置500包括若干个类似于粘附装置100中的那些元件的元件，并且在图5中对类似的元件给予了相同的参考号。粘附装置500可以包括与粘附装置100不同的层的结合。
粘附装置500包括支撑贴片501，该支撑贴片501包括基底层502。基底层502具有上侧面504和下侧面505。下侧面505包括粘合剂涂层。至少一个电极，在此实例中有四个电极207A、207B、207C和207D，被附着到基底层502上并且连接到柔性电路206上。除了是柔性的之外，柔性电路206也可以被配置为可伸展的，例如由于它的几何配置。在一些实施方案中，柔性电路206的一部分可以具有S形或锯齿形。电路载体208保持可以包括天线210的电子元件209。电子元件209电连接到电极207A、207B、207C和207D上并且被配置为测量粘附装置500粘附到其上的受试者的至少一个生理信号。
加强结构217可布置在基底层502的周边区域上方并且直接或间接地耦合到其上，以加强基底层502的周边边缘。在一些实施方案中，覆盖物213布置在电路载体208上方并且在周边218处耦合到基底层502上。在那种情况下，加强结构217布置在覆盖物213上方并且耦合到其上，并且因此间接地耦合到基底层502上。覆盖物213优选是软的并且是柔性的，并且可以由被配置为阻止液体到达电子元件209的材料制成。
同样地，在一些实施方案中，上覆层503可以布置在基底层502之上并且粘附到其上。上覆层503优选是薄的、柔性的并且可伸展的，并且可以由机织布或其他适合的材料制成。当存在上覆层503时，加强结构217也布置在上覆层503的周边上方并且耦合到其上，并且至少加强基底层和上覆层的周边边缘。支撑贴片（例如支撑贴片501或支撑贴片201）的所有层可以是同延的，它们的边缘是如在图2C中所示而对准的。可替代地，支撑贴片中的一个或多个层可以不是与其他层同延的。例如，上覆层503稍微比基底层502小，使得基底层502的边缘延伸超过上覆层503的边缘。这种安排可以进一步减少基底层502的边缘上的压力，从而促进到粘附装置500粘附到其上的受试者的长时间粘附。这样的安排可以用于在此描述的任何实施方案中。
粘附装置500可以包括一个或多个凝胶贴片214A、214B、214C和214D，一个凝胶体布置在每个电极207A、207B、207C和207D下面。凝胶贴片214A、214B、214C和214D提高在电极207A、207B、207C和207D与粘附装置500粘附到其上的受试者皮肤之间的电导率。
在一些实施方案中，基底层502的下侧面505被配置为粘附到受试者的皮肤上。在那样的配置中，凝胶贴片214A、214B、214C和214D被捕获在基底层502与受试者的皮肤之间。任选地，可以提供底层506，粘附到基底层504的下侧面505上，并且被配置为粘附到受试者的皮肤上。优选地，底层506也为薄的、柔性的并且可伸展的。例如，基底层202、底层506或两者都可以由可从美国加利福尼亚州帕萨迪纳的艾利丹尼森公司获得的MED5021聚氨酯薄膜或由可从美国明尼苏达州圣保罗的3M公司获得的TegadermTM膜制成的。可使用其他适合的材料。底层506可以包括开口215A、215B、215C和215D，并且可以将凝胶体214A、214B、214C和214D俘获在形成于基底层502与底层506之间的口袋中。
正如在粘附装置100中一样，粘附装置500可以包括在电路载体208与基底层502之间的顺应性连接件，例如如在图4中所示并且先前描述的顺应性连接件。
图6展示了根据本发明的另外的实施方案的粘附装置600的分解斜视图。在该实施方案中，支撑贴片601可被配置为粘附到受试者的皮肤上，并且可以是如上所述的任何实施方案中的支撑贴片。支撑贴片601可以包括基底层、覆盖层、上覆层、底层或这些层的任何可操作的组合。支撑贴片601可包括一个或多个电连接到柔性电路206上的电极（在图6中不可见）。可以将标签610附着到支撑贴片601上。电路载体208保持各种电子元件209，这些电子元件209可以包括处理器、存储器、无线通信电路、天线210和其他电子元件。粘附装置600还可以包括温度或热通量传感器602。桥接环603A、603B、603C（以及第四个桥接环，在图3B中不可见）被附着到支撑贴片201以及电路载体208上，并且形成一个顺应性结构，该顺应性结构用比其他自由度更加刚性的某自由度来顺应地限制电路载体208相对于支撑贴片601的移动。壳体604和保护器605可以隔绝、缓冲或以其他方式保护电路载体208。粘附装置可以进一步包括电池606或其他能量源、电池盖607、覆盖物608和显示器609。
本披露的粘附装置用来粘附到受试者的皮肤上并且可以包括：可伸展基底装置，具有一个上侧面和一个下侧面以及在下侧面上将基底装置粘附到受试者的皮肤上的粘合剂涂层装置，该基底装置具有至少两个延伸穿过的开口，这至少两个开口中的每个都具有一个尺寸；可伸展覆盖装置，定位在基底装置之上并且用粘合剂粘附到其上以限定至少两个口袋装置；至少两个凝胶体装置，每个凝胶体装置具有比至少两个开口的尺寸更大的尺寸，以将凝胶体基本上保持在口袋装置之内；以及用可伸展基底装置支撑以测量受试者的至少一个生理信号的电路载体装置。
本披露的粘附装置用来监测具有皮肤的受试者并且可以包括：具有一个上侧面和一个下侧面的可伸展的基底装置以及布置在下侧面上将基底装置粘附到受试者的皮肤上的粘合剂装置，该基底装置具有至少两个延伸穿过的开口，每个开口都具有一个尺寸；具有在其上布置有至少两个电极的柔性电路装置，每个电极用至少两个开口的对应的一个来定位，以耦合到受试者的皮肤上；用基底装置中的至少两个开口定位的至少两个凝胶体装置，每个凝胶体装置具有比每个开口的尺寸更大的尺寸；可伸展覆盖装置，定位在至少两个凝胶体装置上方并且粘附到基底装置上，使得每个凝胶体装置基本上限制在布置在基底装置与覆盖装置之间的相应口袋之内；以及保持电子装置的电路载体装置，用柔性电路装置电连接到至少一个电极装置上以测量受试者的至少一个生理信号。
虽然通过举例以及为了清楚地理解，已经在某种程度上详细地描述了示例性实施方案，但是本领域的技术人员将认识到可以采用许多种修改、改编和变化。因此，本发明的范围应当仅由随附的权利要求书来限制。

Claims (57)

1.一种用于粘附到受试者的皮肤上的粘附装置，包括：
一个可伸展基底层，具有一个上侧面和一个下侧面以及在该下侧面上将该基底层粘附到受试者的皮肤上的一个粘合剂涂层，该基底层具有至少两个延伸穿过的开口，这至少两个开口中的每个都具有一个尺寸；
一个可伸展覆盖层，定位于该基底层之上并且用一种粘合剂粘附到其上以限定至少两个口袋；
至少两个凝胶体，每个凝胶体具有比这至少两个开口的尺寸更大的尺寸，以将所述凝胶体实质上保持在所述口袋内；以及
一个电路载体，该电路载体被定位在该可伸展覆盖层之上并用该可伸展基底层来支撑，以测量受试者的至少一个生理信号。
2.如权利要求1所述的粘附装置，其中该可伸展基底层包括一个薄的柔性可伸展基底层，以随着受试者的皮肤伸展并且贴合受试者的皮肤的褶皱。
3.如权利要求1所述的粘附装置，其中该可伸展覆盖层包括一个薄的柔性的可伸展覆盖层，以随着受试者的皮肤伸展并且贴合受试者的皮肤的褶皱。
4.如权利要求1所述的粘附装置，进一步包括布置在该覆盖层之上并且粘附到其上的一个薄的柔性的可伸展上覆层。
5.如权利要求4所述的粘附装置，其中该上覆层是由机织织物制成的。
6.如权利要求1所述的粘附装置，进一步包括布置在该基底层和覆盖层的一个共同周边上方并且耦合到其上的一个加强结构，并且该加强结构被配置为加强该基底层和覆盖层的周边边缘。
7.如权利要求6所述的粘附装置，其中该加强结构被配置为在该粘附装置粘附到受试者之后可移除。
8.如权利要求7所述的粘附装置，进一步包括布置在该覆盖层上方并且粘附到其上的一个薄的柔性的可伸展上覆层，该加强结构布置在该基底层和覆盖层以及该上覆层的一个共同周边上方并且耦合到其上，该加强结构被配置为加强该基底层和覆盖层以及该上覆层的周边边缘。
9.如权利要求1所述的粘附装置，进一步包括一个在该电路载体与该基底层之间的顺应性连接件。
10.如权利要求1所述的粘附装置，其中该基底层和该覆盖层的组合是透气的。
11.如权利要求10所述的粘附装置，其中该基底层和该覆盖层的结合具有至少100g/m2/天的湿气蒸发传输率。
12.一种用于监测具有皮肤的受试者的粘附装置，包括：
一个可伸展基底层，具有一个上侧面和一个下侧面以及布置在该下侧面上将该基底层粘附到受试者的皮肤上的一个粘合剂涂层，该基底层具有至少两个延伸穿过的开口，每个开口都具有一个尺寸；
一个柔性电路支撑物，在其上布置有至少两个电极，每个电极用这至少两个开口中的对应一个来定位，以耦合到受试者的皮肤上；
至少两个凝胶体，该至少两个凝胶体用该基底层中的这至少两个开口来定位，每个凝胶体具有比所述每个开口的尺寸更大的尺寸；
一个可伸展覆盖层，该可伸展覆盖层被定位在这至少两个凝胶体及柔性电路支撑物上方并且粘附到该基底层上，使得每个凝胶体基本上被限制在布置在该基底层与该覆盖层之间的相应口袋之内并且该柔性电路支撑物布置在该基底层与该覆盖层之间；以及
一个电路载体，该电路载体被定位在该可伸展覆盖层之上，用该可伸展基底层来支撑，并保持多个电子元件，电子元件用该柔性电路支撑物电连接到至少一个电极上，以测量受试者的至少一个生理信号。
13.如权利要求12所述的粘附装置，其中这些凝胶体中的每个和这些口袋中的每个的尺寸大于该可伸展基底层的一个相应开口的尺寸，以便当该可伸展基底层粘附到受试者的皮肤上时将所述凝胶体保持在所述口袋中。
14.如权利要求12-13的任一项所述的粘附装置，其中该可伸展基底层包括一个薄的柔性可伸展基底层，以随着受试者的皮肤伸展并且贴合受试者的皮肤的褶皱。
15.如权利要求12-13的任一项所述的粘附装置，其中该可伸展覆盖层包括一个薄的柔性的可伸展覆盖层，以随着受试者的皮肤伸展并且贴合受试者的皮肤的褶皱。
16.如权利要求12-13的任一项所述的粘附装置，进一步包括布置在该覆盖层之上并且粘附到其上的一个薄的柔性的可伸展上覆层。
17.如权利要求16所述的粘附装置，其中该上覆层是由机织织物制成的。
18.如权利要求12-13的任一项所述的粘附装置，进一步包括布置在该基底层和覆盖层的一个共同周边上方并且耦合到其上的一个加强结构，并且该加强结构被配置为加强该基底层和覆盖层的周边边缘。
19.如权利要求18所述的粘附装置，其中该加强结构被配置为在该粘附装置粘附到受试者之后可移除。
20.如权利要求19所述的粘附装置，进一步包括布置在该覆盖层上方并且粘附到其上的一个薄的柔性的可伸展上覆层，该加强结构布置在该基底层和覆盖层以及该上覆层的一个共同周边上方并且耦合到其上，该加强结构被配置为加强该基底层和覆盖层以及该上覆层的周边边缘。
21.如权利要求12所述的粘附装置，进一步包括布置在该电路载体上方并且在一个共同周边处耦合到该基底层和覆盖层上的一个软的柔性覆盖物。
22.如权利要求21所述的粘附装置，其中该覆盖物包括一种被配置为阻止液体到达这些电子元件的材料。
23.如权利要求18所述的粘附装置，其中该覆盖物的一个周边布置在该加强结构的下面。
24.如权利要求12至13的任一项所述的粘附装置，其中该柔性电路支撑物被配置为可伸展的。
25.如权利要求12至13的任一项所述的粘附装置，其中该柔性电路支撑物在几何上被配置为可伸展的。
26.如权利要求25所述的粘附装置，其中该柔性电路支撑物包括：
一个聚酯基底；以及
由银导电墨形成的多个迹线。
27.如权利要求25所述的粘附装置，其中该柔性电路支撑物包括一个S形。
28.如权利要求12-13的任一项所述的粘附装置，进一步包括一个在该电路载体与该基底层之间的顺应性连接件。
29.如权利要求12-13的任一项所述的粘附装置，其中该基底层和该覆盖层的组合是透气的。
30.如权利要求29所述的粘附装置，其中该基底层和该覆盖层的结合具有至少100g/m2/天的湿气蒸发传输率。
31.一种粘附装置，包括：
一个薄的柔性可伸展基底层，具有一个上侧面和一个下侧面以及在该下侧面上的一个粘合剂涂层；该基底层具有至少两个延伸穿过的开口，这至少两个开口中的每个都具有一个尺寸；
一个可伸展覆盖层，定位于该基底层之上并且用一种粘合剂粘附到其上以限定至少两个口袋；
至少两个凝胶体，每个凝胶体具有比这至少两个开口的尺寸更大的尺寸，以将所述凝胶体实质上保持在所述口袋内；以及
至少一个电极，该电极附着到该基底层上并且能够电耦合到受试者的皮肤上；
一个柔性电路，该柔性电路连接到该至少一个电极上；
一个电路载体，该电路载体保持多个电子元件，多个电子元件经由该柔性电路电连接到该至少一个电极上并且被配置为测量受试者的至少一个生理信号；以及
一个加强结构，该加强结构布置在该基底层的一个周边上方并且耦合到其上，并且该加强结构被配置为加强该基底层的周边边缘。
32.如权利要求31所述的粘附装置，其中该加强结构被配置为当该粘附装置粘附到受试者上时可移除。
33.如权利要求31至32的任一项所述的粘附装置，其中该加强结构是由一个乙烯薄片制成的。
34.权利要求31至32的任一项所述的粘附装置，进一步包括布置在该基底层之上并且粘附到其上的一个薄的柔性的可伸展上覆层，该加强结构布置在该基底层和上覆层的一个共同周边上方并且耦合到其上，并且被配置为加强该基底层和上覆层的周边边缘。
35.权利要求31至32的任一项所述的粘附装置，进一步包括在每个电极下面的凝胶贴片，其中每个凝胶贴片提高对应电极与受试者的皮肤之间的电导率。
36.如权利要求31至32的任一项所述的粘附装置，其中该柔性电路被配置为可伸展的。
37.如权利要求31至32的任一项所述的粘附装置，进一步包括布置在该电路载体上方并且在一个周边处耦合到该基底层上的一个软的柔性覆盖物。
38.如权利要求37所述的粘附装置，其中该覆盖物包括一种被配置为阻止液体到达这些电子元件的材料。
39.如权利要求31至32的任一项所述的粘附装置，其中该基底层的下侧面被配置为粘附到受试者的皮肤上。
40.如权利要求31至32的任一项所述的粘附装置，进一步包括粘附到该基底层的下侧面上的一个薄的柔性的可伸展底层，该底层被配置为粘附到受试者的皮肤上。
41.如权利要求40所述的粘附装置，其中该基底层和底层的结合是透气的。
42.如权利要求41所述的粘附装置，其中该基底层和底层的结合具有至少100g/m2/天的湿气蒸发传输率。
43.如权利要求41至42的任一项所述的粘附装置，进一步包括在每个电极下面的凝胶贴片，其中每个凝胶贴片提高对应电极与受试者的皮肤之间的电导率，并且其中每个凝胶贴片的一个周边被夹在该基底层与该底层之间。
44.如权利要求41至42的任一项所述的粘附装置，其中该底层包括至少一个开口，至少一个电极与受试者的皮肤之间的电接触通过该开口而实现。
45.如权利要求41至42的任一项所述的粘附装置，进一步包括一个在该电路载体与该基底层之间的顺应性连接件。
46.一种粘附装置，包括：
一个薄的柔性可伸展基底层，具有一个上侧面和一个下侧面以及在该下侧面上的一个粘合剂涂层；该基底层具有至少两个延伸穿过的开口，这至少两个开口中的每个都具有一个尺寸；
一个可伸展覆盖层，定位于该基底层之上并且用一种粘合剂粘附到其上以限定至少两个口袋；
至少两个凝胶体，每个凝胶体具有比这至少两个开口的尺寸更大的尺寸，以将所述凝胶体实质上保持在所述口袋内；以及至少一个电极，该至少一个电极附着到该基底层上并且能够电耦合到受试者的皮肤上；
一个柔性电路，该柔性电路连接到该至少一个电极上，该柔性电路被配置为伸展，其中该柔性电路在几何上配置为可伸展的；以及
一个电路载体，该电路载体保持多个电子元件，多个电子元件经由该柔性电路电连接到该至少一个电极上并且被配置为测量受试者的至少一个生理信号。
47.如权利要求46所述的粘附装置，其中该柔性电路包括
一个聚酯基底；以及
由银导电墨形成的多个迹线。
48.如权利要求46至47的任一项所述的粘附装置，其中该柔性电路包括一个S形。
49.如权利要求46至47的任一项所述的粘附装置，其中该柔性电路包括一个锯齿形。
50.如权利要求46至47的任一项所述的粘附装置，进一步包括在每个电极下面的凝胶贴片，其中每个凝胶贴片提高对应电极与受试者的皮肤之间的电导率。
51.如权利要求46至47的任一项所述的粘附装置，其中该基底层被配置为粘附到受试者的皮肤上，该粘附装置进一步包括布置在该基底层之上并且粘附到其上的一个薄的柔性的可伸展上覆层。
52.如权利要求46至47的任一项所述的粘附装置，进一步包括布置在该基底层的下面并且粘附到其上的一个薄的柔性的可伸展底层，该底层被配置为粘附到受试者的皮肤上。
53.如权利要求46至47的任一项所述的粘附装置，进一步包括布置在该基底层的一个周边上方并且耦合到其上的一个加强结构，并且该加强结构被配置为加强该基底层的周边边缘。
54.如权利要求46至47的任一项所述的粘附装置，进一步包括一个在该电路载体与该基底层之间的顺应性连接件。
55.一种监测具有皮肤的受试者的粘附装置，包括：
一个可伸展基底层，具有一个上侧面和一个下侧面以及在该下侧面上将该基底层粘附到受试者的皮肤上的一个粘合剂涂层，该基底层具有至少两个延伸穿过的开口，该至少两个开口中的每个都具有一个尺寸；
一个可伸展覆盖层，定位于该基底层之上并且用一种粘合剂粘附到其上以限定至少两个口袋；
一个柔性电路支撑物，该柔性电路支撑物包括第一部分和第二部分，该支撑物的该第一部分粘附在该可伸展基底层与该可伸展覆盖层之间，该第二部分从该第一部分延伸；
至少两个电极，布置在该柔性电路支撑物的该第一部分上；
至少两个凝胶体，其中每个凝胶体和每个电极定位在一个相应口袋之内，每个凝胶体具有比对应开口的尺寸更大的尺寸，以将所述凝胶体基本上保持在该基底层与该覆盖层之间的所述口袋之内；以及
一个电路载体，该电路载体被定位在该可伸展覆盖层之上并用该可伸展基底层来支撑，该电路载体保持多个电子元件，多个电子元件用该柔性电路支撑物的该第二部分电连接到这至少两个电极上，以便当该可伸展基底层随着受试者的皮肤伸展时缓解张力，这些电子元件被配置为测量受试者的至少一个生理信号。
56.一种制造用于粘附到受试者的皮肤上的一种粘附装置的方法，包括：
提供一个可伸展基底层，该基底层具有一个上侧面和一个下侧面以及在该下侧面上将该基底层粘附到一个受试者的皮肤上的一个粘合剂涂层，该基底层具有至少两个延伸穿过的开口，这至少两个开口中的每个都具有一个尺寸；
提供一个柔性电路支撑物，该柔性电路支撑物具有布置在其上的至少两个电极和多个导电材料迹线；
提供至少两个凝胶体；以及
提供一个可伸展覆盖层；
将该柔性电路支撑物和至少两个凝胶体定位在该可伸展基底层与该可伸展覆盖层之间；
将该可伸展基底层粘附到该可伸展覆盖层上以形成至少两个口袋，其中每个口袋具有布置在其中的这至少两个凝胶体中的一个和这些电极中的一个；
用该柔性电路支撑物将一个电路载体耦合到这至少两个电极上。
57.一种监测具有皮肤的患者的方法，该方法包括：
将一个附着到一个可伸展覆盖层上的可伸展基底层粘附到该患者的皮肤上，其中该可伸展基底层和该可伸展覆盖层定义了具有布置在其中的多个凝胶体和多个电极的多个口袋，并且其中这些电极用布置在这些口袋中的这些凝胶体耦合到皮肤上，并且其中一个电路载体被定位在该可伸展覆盖层之上并用该可伸展基底层来支撑；以及
测量来自这些电极的信号并在该电路载体处测量受试者的至少一个生理信号。
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