WO2010107913A2 - Adherent device with oximeter and physiological sensors - Google Patents

Adherent device with oximeter and physiological sensors Download PDF

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Publication number
WO2010107913A2
WO2010107913A2 PCT/US2010/027663 US2010027663W WO2010107913A2 WO 2010107913 A2 WO2010107913 A2 WO 2010107913A2 US 2010027663 W US2010027663 W US 2010027663W WO 2010107913 A2 WO2010107913 A2 WO 2010107913A2
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WO
WIPO (PCT)
Prior art keywords
skin
emitter
adherent device
support
patient
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Application number
PCT/US2010/027663
Other languages
French (fr)
Other versions
WO2010107913A3 (en
Inventor
Scott T. Mazar
Original Assignee
Corventis, Inc.
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Filing date
Publication date
Priority to US16104609P priority Critical
Priority to US61/161,046 priority
Application filed by Corventis, Inc. filed Critical Corventis, Inc.
Publication of WO2010107913A2 publication Critical patent/WO2010107913A2/en
Publication of WO2010107913A3 publication Critical patent/WO2010107913A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements 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
    • A61B5/683Means for maintaining contact with the body
    • A61B5/6832Means for maintaining contact with the body using adhesives
    • A61B5/6833Adhesive patches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/04Measuring bioelectric signals of the body or parts thereof
    • A61B5/0402Electrocardiography, i.e. ECG
    • A61B5/0408Electrodes specially adapted therefor
    • A61B5/04085Multiple electrode holders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radiowaves
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0535Measuring electrical impedance or conductance of a portion of the body impedance plethysmography
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radiowaves
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0537Measuring body composition by impedance, e.g. tissue hydration or fat content
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14552Details of sensors specially adapted therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04Constructional details of apparatus
    • A61B2560/0406Constructional details of apparatus specially shaped apparatus housings
    • A61B2560/0412Low-profile patch shaped housings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb

Abstract

An adherent device comprises an oximeter disposed on an inner portion of the adherent device. The oximeter is configured to couple to the skin of the patient from the inner portion of the device, so as to minimize noise from optical sources and to improve coupling of the oximeter to the skin of the patient. As optical and mechanical noise can be reduced substantially, the circuitry of the oximeter device can be configured to sample with less energy, such that the device can be continuously adhered to the patient for an extended period and provide measurements from a plurality of sensors including the oximeter for the extended period. The adherent device may comprise electrodes and the components of the oximeter may be positioned between the electrodes improve coupling and decrease noise from optical sources.

Description

ADHERENT DEVICE WITH OXIMETER AND PHYSIOLOGICAL

SENSORS

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] The present application claims the benefit under 35 USC 119(e) of US Provisional Application No. 61/161,046 filed March 17, 2009; the full disclosure of which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention. The present invention relates to patient monitoring. Although embodiments make specific reference to monitoring oximetry and electrocardiogram signals with an adherent patch device, the system methods and device described herein may be applicable to many applications in which physiological monitoring is used, for example wireless physiological monitoring for extended periods.

[0003] Patients are often treated for diseases and/or conditions associated with a compromised status of the patient, for example a compromised physiologic status. In some instances, a patient may report symptoms that require diagnosis to determine the underlying cause. For example, a patient may report fainting or dizziness that requires diagnosis, in which long term monitoring of the patient can provide useful information as to the physiologic status of the patient. In some instances a patient may have suffered a heart attack and require care and/or monitoring after release from the hospital. One example of a device to provide long term monitoring of a patient is the Holter monitor, or ambulatory electrocardiography device.

[0004] Therefore, a need exists for improved patient monitoring. Ideally, such improved patient monitoring would avoid at least some of the short-comings of the present methods and devices. [0005] 2. Description of the Background Art. The following U.S. Patents and Publications may describe relevant background art: 3,170,459; 3,370,459; 3,805,769; 3,845,757; 3,972,329;

4,121,573; 4,141,366; 4,838,273; 4,955,381; 4,981,139; 5,080,099; 5,353,793; 5,511,553;

5,544,661; 5,558,638; 5,724,025; 5,772,586; 5,862,802; 6,047,203; 6,117,077; 6,129,744;

6,225,901; 6,385,473; 6,416,471; 6,454,707; 6,527,711; 6,527,729; 6,551,252; 6,595,927; 6,595,929; 6,605,038; 6,645,153; 6,795,722; 6,821,249; 6,980,851; 7,020,508; 7,054,679; 7,153,262; 2003/0092975; 2005/0113703; 2005/0131288; 2006/0010090; 2006/0031102; 2006/0089679; 2006/0155183; 2006/122474; 2006/0224051; 2006/0264730; 2007/0021678; and 2007/0038038.

BRIEF SUMMARY OF THE INVENTION [0006] The present invention relates to patient monitoring. Although embodiments make specific reference to monitoring, electrocardiogram, and pulse oximetry signals with an adherent patch device , the system methods and device described herein may be applicable to any application in which physiological monitoring is used, for example wireless physiological monitoring for extended periods. [0007] Embodiments of the present invention provide an adherent device with an improved oximeter. The oximeter can be disposed on an inner portion of the adherent device and configured to couple to the skin of the patient from the inner portion, so as to minimize noise from optical sources such as ambient light and also so as to improve coupling of the oximeter to the skin of the patient. As optical and mechanical noise may be reduced substantially, the circuitry of the oximeter device can be configured to sample with less energy, such that the device can be continuously adhered to the patient for an extended period and provide measurements from a plurality of sensors for the extended period, for example an extended period of at least one week. The adherent device may comprise a support, for example a breathable tape, and the oximeter may be coupled to an inner portion of the support so as to improve coupling of the oximeter to skin. The support may comprise a substantially optically non-transmissive material adhered to the skin, such that light transmission through the support adhered to the skin is inhibited and the optical signal from the oximeter significantly improved. The adherent device may comprise electrodes and the components of the oximeter may be positioned between the electrodes, such that coverage of the adherent device over the skin coupled to the oximeter can be sized to decrease noise from optical sources. The adherent device may comprise optically non-transmissive components disposed over the support to minimize light transmission through the adherent device to the skin, for example one or more of an optically non-transmissive gel cover, an optically non-transmissive flexible electrode strip, an optically non-transmissive circuitry board, or an optically non-transmissive cover. The adherent device may comprise additional sensors, for example an accelerometer coupled to the support, that may also be used to suppress noise from other sources, for example patient movement that may effect coupling of the oximeter to the skin. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure IA shows a patient and a monitoring system comprising an adherent device, according to embodiments of the present invention; [0009] Figures IB to 1B3 show a bottom view of adherent device comprising an adherent patch according to embodiments of the present invention;

[0010] Figure 1C shows a top view of the adherent patch, as in Figure IB;

[0011] Figure ID shows a printed circuit boards and electronic components over the adherent patch, as in Figure 1C; [0012] Figure IDl shows an equivalent circuit that can be used to determine optimal frequencies for determining patient hydration, according to embodiments of the present invention;

[0013] Figure IE shows batteries positioned over the printed circuit board and electronic components as in Figure ID; [0014] Figure IF shows a top view of an electronics housing and a breathable cover over the batteries, electronic components and printed circuit board as in Figure IE;

[0015] Figure IG shows a side view of the adherent device as in Figures IA to IF;

[0016] Figure IH shown a bottom isometric view of the adherent device as in Figures IA to IG; [0017] Figures II and IJ show a side cross-sectional view and an exploded view, respectively, of the adherent device as in Figures IA to IH;

[0018] Figures 111 and IJl show a side cross-sectional view and an exploded view, respectively, of embodiments of the adherent device with a temperature sensor affixed to the gel cover; [0019] Figures 112 and 1J2 show a side cross-sectional view and an exploded view, respectively, of a middle portion of embodiments of the adherent device;

[0020] Figure 112 A shows a side cross-sectional view of the middle portion in accordance with embodiments of the adherent device. [0021] Figure IK shows at least one electrode configured to electrically couple to a skin of the patient through a breathable tape, according to embodiments of the present invention;

[0022] Figures 2A to 2C show a system to monitor a patient for an extended period comprising a reusable electronic component and a plurality of disposable patch components, according to embodiments of the present invention;

[0023] Figure 2D shows a method of using the system as in Figures 2A to 2C;

[0024] Figures 3 A to 3F show a method of manufacturing embodiments of the adherent device; and

[0025] Figures 4A to 4F show a method of manufacturing embodiments of the adherent device.

DETAILED DESCRIPTION OF THE INVENTION

[0026] Embodiments of the present invention relate to patient monitoring. Although embodiments make specific reference to monitoring impedance, electrocardiogram, and pulse oximetry signals with an adherent patch, the system methods and device described herein may be applicable to any application in which physiological monitoring is used, for example wireless physiological monitoring for extended periods.

[0027] The adherent device may comprise a support, for example a patch that may comprise breathable tape, and the support can be configured to adhere to the patient and support the electronics and sensors on the patient. The support can be porous and breathable so as to allow water vapor transmission. The support can also stretch with skin of the patient, so as to improve patient comfort and extend the time that the support can be adhered to the patient.

[0028] In many embodiments, the adherent devices described herein may be used for 90 day monitoring, or more, and may comprise completely disposable components and/or reusable components, and can provide reliable data acquisition and transfer. In many embodiments, the patch is configured for patient comfort, such that the adherent patch can be worn and/or tolerated by the patient for extended periods, for example 90 days or more. The patch may be worn continuously for at least seven days, for example 14 days, and then replaced with another patch. Adherent devices with comfortable patches that can be worn for extended periods and in which patches can be replaced and the electronics modules reused are described in U.S. Pat. App. Nos. 60/972,537, entitled "Adherent Device with Multiple Physiological Sensors"; and 60/972,629, entitled "Adherent Device with Multiple Physiological Sensors", both filed on September 14, 2007, the full disclosures of which have been previously incorporated herein by reference. In many embodiments, the adherent patch comprises a tape, which comprises a material, preferably breathable, with an adhesive, such that trauma to the patient skin can be minimized while the patch is worn for the extended period. The printed circuit board may comprise a flex printed circuit board that can flex with the patient to provide improved patient comfort.

[0029] Figure IA shows a patient P and a monitoring system 10. Patient P comprises a midline M, a first side S 1 , for example a right side, and a second side S2, for example a left side. Monitoring system 10 comprises an adherent device 100. Adherent device 100 can be adhered to a patient P at many locations, for example thorax T of patient P. In many embodiments, the adherent device may adhere to one side of the patient, from which side data can be collected. Work in relation with embodiments of the present invention suggests that location on a side of the patient can provide comfort for the patient while the device is adhered to the patient.

[0030] Monitoring system 10 includes components to transmit data to a remote center 106. Remote center 106 can be located in a different building from the patient, for example in the same town as the patient, and can be located as far from the patient as a separate continent from the patient, for example the patient located on a first continent and the remote center located on a second continent. Adherent device 100 can communicate wirelessly to an intermediate device 102, for example with a single wireless hop from the adherent device on the patient to the intermediate device. Intermediate device 102 can communicate with remote center 106 in many ways, for example with an internet connection and/or with a cellular connection. In many embodiments, monitoring system 10 comprises a distributed processing system with at least one processor comprising a tangible medium of device 100, at least one processor 102P of intermediate device 102, and at least one processor 106P at remote center 106, each of which processors can be in electronic communication with the other processors. At least one processor 102P comprises a tangible medium 102T, and at least one processor 106P comprises a tangible medium 106T. Remote processor 106P may comprise a backend server located at the remote center. Remote center 106 can be in communication with a health care provider 108 A with a communication system 107 A, such as the Internet, an intranet, phone lines, wireless and/or satellite phone. Health care provider 108 A, for example a family member, can be in communication with patient P with a communication, for example with a two way communication system, as indicated by arrow 109 A, for example by cell phone, email, landline. Remote center 106 can be in communication with a health care professional, for example a physician 108B, with a communication system 107B, such as the Internet, an intranet, phone lines, wireless and/or satellite phone. Physician 108B can be in communication with patient P with a communication, for example with a two way communication system, as indicated by arrow 109B, for example by cell phone, email, landline. Remote center 106 can be in communication with an emergency responder 108C, for example a 911 operator and/or paramedic, with a communication system 107C, such as the Internet, an intranet, phone lines, wireless and/or satellite phone. Emergency responder 108C can travel to the patient as indicated by arrow 109C. Thus, in many embodiments, monitoring system 10 comprises a closed loop system in which patient care can be monitored and implemented from the remote center in response to signals from the adherent device. [0031] In many embodiments, the adherent device may continuously monitor physiological parameters, communicate wirelessly with a remote center, and provide alerts when necessary. The system may comprise an adherent patch, which attaches to the patient's thorax and contains sensing electrodes, battery, memory, logic, and wireless communication capabilities. In some embodiments, the patch can communicate with the remote center, via the intermediate device in the patient's home. In some embodiments, remote center 106 receives the patient data and applies a patient evaluation algorithm, for example the prediction algorithm to predict cardiac decompensation. In some embodiments, the algorithm may comprise an algorithm to predict impending cardiac decompensation is described in U.S. Pat. App. No. 60/972,512, the full disclosure of which has been previously incorporated herein by reference. In some embodiments, an algorithm to detect hypoxia can be applied. When a flag is raised, the center may communicate with the patient, hospital, nurse, and/or physician to allow for therapeutic intervention, for example to prevent decompensation and/or restore the blood oxygenation level of the patient to normal, healthy levels.

[0032] The adherent device may be affixed and/or adhered to the body in many ways. For example, with at least one of the following an adhesive tape, a constant-force spring, suspenders around shoulders, a screw-in microneedle electrode, a pre-shaped electronics module to shape fabric to a thorax, a pinch onto roll of skin, or transcutaneous anchoring. Patch and/or device replacement may occur with a keyed patch (e.g. two-part patch), an outline or anatomical mark, a low-adhesive guide (place guide | remove old patch | place new patch | remove guide), or a keyed attachment for chatter reduction. The patch and/or device may comprise an adhesiveless embodiment (e.g. chest strap), and/or a low-irritation adhesive for sensitive skin. The adherent patch and/or device can comprise many shapes, for example at least one of a dogbone, an hourglass, an oblong, a circular or an oval shape. [0033] In many embodiments, the adherent device may comprise a reusable electronics module with replaceable patches, and each of the replaceable patches may include a battery. The module may collect cumulative data for approximately 90 days and/or the entire adherent component (electronics + patch) may be disposable. In a completely disposable embodiment, a "baton" mechanism may be used for data transfer and retention, for example baton transfer may include baseline information. In some embodiments, the device may have a rechargeable module, and may use dual battery and/or electronics modules, wherein one module 101 A can be recharged using a charging station 103 while the other module 10 IB is placed on the adherent patch with connectors. In some embodiments, the intermediate device 102 may comprise the charging module, data transfer, storage and/or transmission, such that one of the electronics modules can be placed in the intermediate device for charging and/or data transfer while the other electronics module is worn by the patient.

[0034] System 10 can perform the following functions: initiation, programming, measuring, storing, analyzing, communicating, predicting, and displaying. The adherent device may contain a subset of the following physiological sensors: bioimpedance, respiration, respiration rate variability, heart rate (ave, min, max), heart rhythm, hear rate variability (HRV), heart rate turbulence (HRT), heart sounds (e.g. S3), respiratory sounds, blood pressure, activity, posture, wake/sleep, orthopnea, temperature/heat flux, weight, tissue perfusion, and blood oxygenation. The activity sensor may comprise one or more of the following: ball switch, accelerometer, minute ventilation, HR, bioimpedance noise, skin temperature/heat flux, BP, muscle noise, posture.

[0035] The adherent device can wirelessly communicate with remote center 106. The communication may occur directly (via a cellular or Wi-Fi network), or indirectly through intermediate device 102. Intermediate device 102 may consist of multiple devices, which can communicate wired or wirelessly to relay data to remote center 106.

[0036] In many embodiments, instructions are transmitted from remote site 106 to a processor supported with the adherent patch on the patient, and the processor supported with the patient can receive updated instructions for the patient treatment and/or monitoring, for example while worn by the patient. [0037] Figure IB shows a bottom view of adherent device 100 as in Figure IA comprising an adherent patch 110. Adherent patch 110 comprises a first side, or a lower side 11OA, that is oriented toward the skin of the patient when placed on the patient. In many embodiments, adherent patch 110 comprises a tape HOT which is a material, preferably breathable, with an adhesive 116 A. Patient side 11OA comprises adhesive 116A to adhere the patch 110 and adherent device 100 to patient P. Electrodes 112A, 112B, 112C and 112D are affixed to adherent patch 110. In many embodiments, at least four electrodes are attached to the patch, for example six electrodes. In some embodiments the patch comprises two electrodes, for example two electrodes to measure the electrocardiogram (ECG) of the patient. Gel 114A, gel 114B, gel 114C and gel 114D can each be positioned over electrodes 112 A, 112B, 112C and 112D, respectively, to provide electrical conductivity between the electrodes and the skin of the patient. In many embodiments, the electrodes can be affixed to the patch 110, for example with known methods and structures such as rivets, adhesive, stitches, etc. In many embodiments, patch 110 comprises a breathable material to permit air and/or vapor to flow to and from the surface of the skin.

[0038] The tape 11OT of adherent patch 110 can define an aperture or opening 115 disposed at the middle of tape 11OT. A physiological sensor device or a therapeutic device may extend through the opening 115 to directly contact and/or be directly exposed to the skin of the patient, bypassing tape HOT and adhesive 116 A. As shown in Figure IB, a pulse oximeter 121 extends through opening 115 which is disposed between electrode 112B and electrode 112C. The aperture or opening 115 can be sized to closely fit with the external housing of the pulse oximeter 121. The pulse oximeter 121 can be aligned with electrodes 112A, 112B, 112C and 112D. The aperture or opening 115 provides a clear optical path between the pulse oximeter 121 and the skin of the patient. In some embodiments, the pulse oximeter 121 can be removed from the adherent patch 110 through opening 115 and be replaced.

[0039] Placing the pulse oximeter 121 at the middle of adherent patch 110 can have many advantages. Exposure to external or ambient light may adversely affect the function of the pulse oximeter 121. The adherent patch 110 may be opaque and/or comprise opaque layers, i.e., comprise a substantially non-optically transmissive material, which may shield the pulse oximeter 121 from external or ambient light. Placing the pulse oximeter 121 in an inner portion of adherent patch 110, for example in the middle of adherent patch 110, can maximize this shielding. Over an extended period of time, adhesive 116A may begin to peel away from the skin of the patient, in some instances beginning with the outer edges of adhesive 116 A. Placing the pulse oximeter 121 in the middle of adherent patch 121 can minimize exposure to external or ambient light leaking through the peeled away portions of adhesive 116 A. In many embodiments, the housing of the pulse oximeter 121 may comprise an optically non-transmissive or opaque material to minimize exposure of the light emitting and detecting components of pulse oximeter 121 to external or ambient light.

[0040] The pulse oximeter 121 comprises a first light emitter 124A, a second light emitter 124B, and a photo detector 126. The first light emitter 124 A and the second light emitter 124B emit light onto the skin of the patient. The photodetector 126 detects the light reflected from the skin and underlying tissue of the patient. Circuitry in pulse oximeter 121 determines the blood oxygenation level of the patient based on the detected light. The first light emitter 124A and the second light emitter 124B may be separated from each other by an emitter separation distance. The photo detector 126 may be separated from the first light emitter 124A or the second light emitter 124B by a maximum distance of at least about five times the emitter separation distance. For example, an emitter may be spaced away from the photo detector 126 by a distance of less than about 1 inch, preferably 1Zi inch, and no more than about 0.05 inches. The first and second light emitters may be closer to each other than to the photodetector. The first light emitter 124 A may emit light at a first wavelength, for example, a visible light wavelength, for example, 660 nm. The second light emitter 124B may emit light at a second wavelength, for example, an infrared light wavelength, for example, 910 nm or 940 nm. The first light emitter 124A may comprise light emitting diodes (LEDs), lasers, laser diodes, vertical-cavity surface-emitting lasers (VCSEL), or other monochromatic light sources. Likewise, the second light emitter 124B may comprise light emitting diodes (LEDs), lasers, laser diodes, vertical-cavity surface-emitting lasers (VCSEL), or other monochromatic light sources. In some embodiments, lasers may be more energy efficient than LEDs and may enhance the battery life of the adherent patch 100 if used.

[0041] In many embodiments, the pulse oximeter 121 may emit light onto the skin and underlying tissue of the patient by activating the first light emitter 124 A while having the second light emitter 124B off and then activating the second light emitter 124B while having the first light emitter 124A off. In some embodiments, for example, in embodiments where the light emitters comprise LEDs, the light emitters may be activated and emit light at a high intensity for a short period of time, for example within a range from about 300 to 700 μs. In at least some of such embodiments, the duty cycle of the light emitters is low, for example, no more than about 10 percent, no more than about 5 percent, and no more than about 1 percent. The light emission or pulses from the light emitters may be pulsed at a repetition or sampling rate of about 10 Hz to about 1 kHz. In some embodiments, the sampling rate of the pulse oximeter 121 may be about 70 Hz. [0042] The oximeter device can be configured to minimize effects of ambient light and increase battery life. Ambient light may comprise a 120 Hz component due to a 60 Hz frequency of the power line. Aliasing can occur due to optical interference with signals that are near the frequency of ambient light, for example near 60 Hz. A sample rate of about 70 Hz can reduce aliasing and the occurrence of a frequency difference signal that would otherwise occur due to the periodic local line frequency of ambient light. As it would be helpful to sample at many frequencies, including 60 Hz, the adherent device comprises one or more optically non- transmissive layers so as to minimize the effect of ambient light. The adherent device comprising the optically non-transmissive components can be used at sampling rates of 60 Hz and 120 Hz due to decreased optical noise, and may use lower pulse currents and pulse durations so as to extend battery life when the adherent device is continuously adhered to the patient for at least one week.

[0043] The first light transmitter 124 A and the second light transmitter 124B can have various arrangements. As shown in Figure IB, the first light transmitter 124A and the second light transmitter 124B can be arranged so as to form a line transverse to the central, longitudinal axis of the adherent patch 100. As shown in Figure IBl, the first light transmitter 124A and the second light transmitter 124B can be arranged as to form a line parallel to the central, longitudinal axis of the adherent patch 100. The photo detector 126 is disposed opposite of first light transmitter 124A and the second light transmitter 124B across the central, longitudinal axis of the adherent patch 100. As shown in Figure 1B2, the first light transmitter 124A, the second light transmitter 124B, and the photo detector 126 can be arranged along the central, longitudinal axis of the adherent patch 100. As shown in Figure 1B3, the first light transmitter 124A, the second light transmitter 124B, and the photo detector 126 can be arranged so as to form a long transverse to the central, longitudinal axis of the adherent patch 100. [0044] Figure 1C shows a top view of the adherent patch 100, as in Figure IB. Adherent patch 100 comprises a second side, or upper side 11OB. In many embodiments, electrodes 112A, 112B, 112C and 112D extend from lower side 11OA through adherent patch 110 to upper side HOB. In some embodiments, the opening or aperture 115 may extend all the way from the bottom side 11OA of the adherent patch 100 to the upper side HOB. An adhesive 116B can be applied to upper side 11OB to adhere structures, for example a breathable cover, to the patch such that the patch can support the electronics and other structures when the patch is adhered to the patient. The PCB may comprise completely flex PCB, rigid PCB, rigid PCB combined flex PCB and/or rigid PCB boards connected by cable. [0045] Figure ID shows a printed circuit boards and electronic components over adherent patch 110, as in Figures IA to 1C. In some embodiments, a printed circuit board (PCB), for example flex printed circuit board 120, may be connected to electrodes 112 A, 112B, 112C and 112D with connectors 122 A, 122B, 122C and 122D. Flex printed circuit board 120 can include traces 123A, 123B, 123C and 123D that extend to connectors 122A, 122B, 122C and 122D, respectively, on the flex PCB. Connectors 122A, 122B, 122C and 122D can be positioned on flex printed circuit board 120 in alignment with electrodes 112 A, 112B, 112C and 112D so as to electrically couple the flex PCB with the electrodes. In some embodiments, connectors 122A, 122B, 122C and 122D may comprise insulated wires and/or a film with conductive ink that provide strain relief between the PCB and the electrodes. For example, connectors 122A, 122B, 122C and 122D may comprise a flexible film, such as at least one of known polyester film or known polyurethane file coated with a conductive ink, for example a conductive silver ink. In some embodiments, additional PCB's, for example rigid PCB's 120A, 120B, 120C and 120D, can be connected to flex printed circuit board 120. Electronic components 130 can be connected to flex printed circuit board 120 and/or mounted thereon. In some embodiments, electronic components 130 can be mounted on the additional PCB's. In some embodiments, the opening or aperture 115 may extend through printed circuit board 120. Figure ID shows a cross-section of the pulse oximeter 121 which comprises pulse oximeter circuitry 127.

[0046] Electronic components 130 comprise components to take physiologic measurements, transmit data to remote center 106 and receive commands from remote center 106. In many embodiments, electronics components 130 may comprise known low power circuitry, for example complementary metal oxide semiconductor (CMOS) circuitry components. Electronics components 130 comprise an activity sensor and activity circuitry 134, impedance circuitry 136 and electrocardiogram circuitry, for example ECG circuitry 136. In some embodiments, electronics circuitry 130 may comprise a microphone and microphone circuitry 142 to detect an audio signal from within the patient, and the audio signal may comprise a heart sound and/or a respiratory sound, for example an S3 heart sound and a respiratory sound with rales and/or crackles.

[0047] Electronics circuitry 130 may comprise a temperature sensor, for example a thermistor in contact with the skin of the patient, and temperature sensor circuitry 144 to measure a temperature of the patient, for example a temperature of the skin of the patient. A temperature sensor may be used to determine the sleep and wake state of the patient. The temperature of the patient can decrease as the patient goes to sleep and increase when the patient wakes up. [0048] In many embodiments, the physiological measurements may be combined to diagnose and/or treat the patient. For example, at least two of the ECG measurement, the pulse oximetry measurement, and the temperature measurement can be combined to detect hypoxia of the patient. For example, at least two of the ECG measurement, the activity measurement, and the pulse oximetry measurement can be combined to detect the occurrence of an apnea of a patient with sleep apnea. The patient can then be treated based on the detected condition.

[0049] Work in relation to embodiments of the present invention suggests that skin temperature may effect impedance and/or hydration measurements, and that skin temperature measurements may be used to correct impedance and/or hydration measurements. In some embodiments, increase in skin temperature or heat flux can be associated with increased vasodilation near the skin surface, such that measured impedance measurement decreased, even through the hydration of the patient in deeper tissues under the skin remains substantially unchanged. Thus, use of the temperature sensor can allow for correction of the hydration signals to more accurately assess the hydration, for example extra cellular hydration, of deeper tissues of the patient, for example deeper tissues in the thorax.

[0050] Electronics circuitry 130 may comprise a processor 146. Processor 146 comprises a tangible medium, for example read only memory (ROM), electrically erasable programmable read only memory (EEPROM) and/or random access memory (RAM). Electronic circuitry 130 may comprise real time clock and frequency generator circuitry 148. In some embodiments, processor 136 may comprise the frequency generator and real time clock. The processor can be configured to control a collection and transmission of data from the impedance circuitry electrocardiogram circuitry and the accelerometer. In many embodiments, device 100 comprise a distributed processor system, for example with multiple processors on device 100. In some embodiments, the pulse oximeter 121 may be coupled to the processor 146, and the processor 146 may receive data, for example, light emission and reflection data and/or patient oxygenation data, from the pulse oximeter 121. In certain embodiments, the processor 146 comprises a tangible medium configured to determine oxygen, e.g., the oxygenation level, of the patient. Alternatively or in combination, the pulse oximeter circuitry 127 of the pulse oximeter 121 may comprise a tangible medium configured for determining oxygen, e.g., the oxygenation level, of the patient.

[0051] In many embodiments, electronics components 130 comprise wireless communications circuitry 132 to communicate with remote center 106. Printed circuit board 120 may comprise an antenna to facilitate wireless communication. The antenna may be integral with printed circuit board 120 or may be separately coupled thereto. The wireless communication circuitry can be coupled to the impedance circuitry, the electrocardiogram circuitry and the accelerometer to transmit to a remote center with a communication protocol at least one of the hydration signal, the electrocardiogram signal or the inclination signal. In specific embodiments, wireless communication circuitry is configured to transmit the hydration signal, the electrocardiogram signal and the inclination signal to the remote center with a single wireless hop, for example from wireless communication circuitry 132 to intermediate device 102. The communication protocol comprises at least one of Bluetooth, ZigBee, WiFi, WiMAX, IR, amplitude modulation or frequency modulation. In many embodiments, the communications protocol comprises a two way protocol such that the remote center is capable of issuing commands to control data collection.

[0052] Intermediate device 102 may comprise a data collection system to collect and store data from the wireless transmitter. The data collection system can be configured to communicate periodically with the remote center. The data collection system can transmit data in response to commands from remote center 106 and/or in response to commands from the adherent device.

[0053] Activity sensor and activity circuitry 134 can comprise many known activity sensors and circuitry. In many embodiments, the accelerometer comprises at least one of a piezoelectric accelerometer, capacitive accelerometer or electromechanical accelerometer. The accelerometer may comprises a 3-axis accelerometer to measure at least one of an inclination, a position, an orientation or acceleration of the patient in three dimensions. Work in relation to embodiments of the present invention suggests that three dimensional orientation of the patient and associated positions, for example sitting, standing, lying down, can be very useful when combined with data from other sensors, for example ECG data and/or hydration data.

[0054] Impedance circuitry 136 can generate both hydration data and respiration data. In many embodiments, impedance circuitry 136 is electrically connected to electrodes 112A, 112B, 112C and 112D in a four pole configuration, such that electrodes 112A and 112D comprise outer electrodes that are driven with a current and comprise force electrodes that force the current through the tissue. The current delivered between electrodes 112A and 112D generates a measurable voltage between electrodes 112B and 112C, such that electrodes 112B and 112C comprise inner, sense, electrodes that sense and/or measure the voltage in response to the current from the force electrodes. In some embodiments, electrodes 112B and 112C may comprise force electrodes and electrodes 112A and 112B may comprise sense electrodes. The voltage measured by the sense electrodes can be used to measure the impedance of the patient and determine the respiration rate and/or hydration of the patient.

[0055] Figure IDl shows an equivalent circuit 152 that can be used to determine optimal frequencies for measuring patient hydration. Work in relation to embodiments of the present invention indicates that the frequency of the current and/or voltage at the force electrodes can be selected so as to provide impedance signals related to the extracellular and/or intracellular hydration of the patient tissue. Equivalent circuit 152 comprises an intracellular resistance 156, or R(ICW) in series with a capacitor 154, and an extracellular resistance 158, or R(ECW). Extracellular resistance 158 is in parallel with intracellular resistance 156 and capacitor 154 related to capacitance of cell membranes. In many embodiments, impedances can be measured and provide useful information over a wide range of frequencies, for example from about 0.5 kHz to about 200 KHz. Work in relation to embodiments of the present invention suggests that extracellular resistance 158 can be significantly related extracellular fluid and to cardiac decompensation, and that extracellular resistance 158 and extracellular fluid can be effectively measured with frequencies in a range from about 0.5 kHz to about 20 kHz, for example from about 1 kHz to about 10 kHz. In some embodiments, a single frequency can be used to determine the extracellular resistance and/or fluid. As sample frequencies increase from about 10 kHz to about 20 kHz, capacitance related to cell membranes decrease the impedance, such that the intracellular fluid contributes to the impedance and/or hydration measurements. Thus, many embodiments of the present invention measure hydration with frequencies from about 0.5 kHz to about 20 kHz to determine patient hydration.

[0056] In many embodiments, impedance circuitry 136 can be configured to determine respiration of the patient. In specific embodiments, the impedance circuitry can measure the hydration at 25 Hz intervals, for example at 25 Hz intervals using impedance measurements with a frequency from about 0.5 kHz to about 20 kHz.

[0057] ECG circuitry 138 can generate electrocardiogram signals and data from two or more of electrodes 112 A, 112B, 112C and 112D in many ways. In some embodiments, ECG circuitry 138 is connected to inner electrodes 112B and 122C, which may comprise sense electrodes of the impedance circuitry as described above. In some embodiments, ECG circuitry 138 can be connected to electrodes 112A and 112D so as to increase spacing of the electrodes. The inner electrodes may be positioned near the outer electrodes to increase the voltage of the ECG signal measured by ECG circuitry 138. In many embodiments, the ECG circuitry may measure the ECG signal from electrodes 112A and 112D when current is not passed through electrodes 112A and 112D, for example with switches as described in U.S. App. No. 60/972,527, the full disclosure of which has been previously incorporated herein by reference.

[0058] Figure IE shows batteries 150 positioned over the flex printed circuit board and electronic components as in Figure ID. Batteries 150 may comprise rechargeable batteries that can be removed and/or recharged. In some embodiments, batteries 150 can be removed from the adherent patch and recharged and/or replaced.

[0059] Figure IF shows a top view of a cover 162 over the batteries, electronic components and flex printed circuit board as in Figures IA to IE. In many embodiments, an electronics housing 160 may be disposed under cover 162 to protect the electronic components, and in some embodiments electronics housing 160 may comprise an encapsulant over the electronic components and PCB. In some embodiments, cover 162 can be adhered to adherent patch 110 with an adhesive 164 on an underside of cover 162. In many embodiments, electronics housing 160 may comprise a water proof material, for example a sealant adhesive such as epoxy or silicone coated over the electronics components and/or PCB. In some embodiments, electronics housing 160 may comprise metal and/or plastic. Metal or plastic may be potted with a material such as epoxy or silicone.

[0060] Cover 162 may comprise many known biocompatible cover, casing and/or housing materials, such as elastomers, for example silicone. The elastomer may be fenestrated to improve breathability. In some embodiments, cover 162 may comprise many known breathable materials, for example polyester, polyamide, nylon and/or elastane (Spandex™). The breathable fabric may be coated to make it water resistant, waterproof, and/or to aid in wicking moisture away from the patch.

[0061] Figure IG shows a side view of adherent device 100 as in Figures IA to IF. Adherent device 100 comprises a maximum dimension, for example a length 170 from about 4 to 10 inches (from about 100 mm to about 250mm), for example from about 6 to 8 inches (from about 150 mm to about 200 mm). In some embodiments, length 170 may be no more than about 6 inches (no more than about 150 mm). Adherent device 100 comprises a thickness 172. Thickness 172 may comprise a maximum thickness along a profile of the device. Thickness 172 can be from about 0.2 inches to about 0.6 inches (from about 5 mm to about 15 mm), from about 0.2 inches to about 0.4 inches (from about 5 mm to about 10 mm), for example about 0.3 inches (about 7.5 mm). [0062] Figure IH shown a bottom isometric view of adherent device 100 as in Figures IA to IG. Adherent device 100 comprises a width 174, for example a maximum width along a width profile of adherent device 100. Width 174 can be from about 2 to about 4 inches (from about 50 mm to 100 mm), for example about 3 inches (about 75 mm). [0063] Figures II and U show a side cross-sectional view and an exploded view, respectively, of adherent device 100 as in Figures IA to IH. Device 100 comprises several layers. Gel 114A, or gel layer, is positioned on electrode 112A to provide electrical conductivity between the electrode and the skin. Electrode 112A may comprise an electrode layer. Adherent patch 110 may comprise a layer of breathable tape 11OT, for example a known breathable tape, such as tricot-knit polyester fabric. An adhesive 116A, for example a layer of acrylate pressure sensitive adhesive, can be disposed on underside 11OA of adherent patch 110.

[0064] Figures 111 and IJl show a side cross-sectional view and an exploded view, respectively, of embodiments of the adherent device with a temperature sensor affixed to the gel cover. The adherent device may comprise the temperature sensor and the oximeter as described herein. For example the oximeter may be disposed in an inner portion of the adherent device and the temperature sensor disposed in a peripheral portion of the adherent device. In these embodiments, gel cover 180 may extend over a wider area than in the embodiments shown in Figures II and IJ. The first emitter 124A, second emitter 124B and photo detector 126 may be disposed on a lower side of the strip 112F, for example as shown and described with reference Figures 4A to 4F. The flexible strip may extend to the temperature sensor to couple to and support the temperature sensor. Temperature sensor 177 is disposed over a peripheral portion of gel cover 180. Temperature sensor 177 can be affixed to gel cover 180 such that the temperature sensor can move when the gel cover stretches and tape stretch with the skin of the patient. Temperature sensor 177 may be coupled to temperature sensor circuitry 144 through a flex connection comprising at least one of wires, shielded wires, non-shielded wires, a flex circuit, or a flex PCB. This coupling of the temperature sensor allows the temperature near the skin to be measured though the breathable tape and the gel cover. The temperature sensor can be affixed to the breathable tape, for example through a cutout in the gel cover with the temperature sensor positioned away from the gel pads. A heat flux sensor can be positioned near the temperature sensor, for example to measure heat flux through to the gel cover, and the heat flux sensor coupled to heat flux circuitry similar to the temperature sensor.

[0065] Figures 112 and IJ2 shows a side cross-sectional view and an exploded view, respectively, of the middle portion of embodiments of the adherent device 100. The pulse oximeter 121 is placed into aperture or opening 115. In many embodiments, the layer of breathable tape HOT defines a first aperture 1 IOTA and a second aperture 110TB. In some embodiments, for example, as shown in Figure 1 J2, the first aperture 1 IOTA and the second aperture 1 IOTB are disposed on opposite lateral sides of a flexible strip 112F. The first aperture 1 IOTA is configured to expose the first light emitter 124A to a clear optical path toward the skin of the patient. The second aperture 1 IOTA is configured to expose the second light emitter 124B to a clear optical path toward the skin of the patient. A portion of the layer of breathable tape HOT between the first aperture 1 IOTA and the second aperture 1 IOTB shields the first light emitter 124 A from the second light emitter 124B. For example, the layer of breathable tape 11OT can comprise a substantially non-optically transmissive material, i.e., be opaque. In many embodiments, the layer of breathable tape HOT further defines a third aperture for the photo detector 126. Alternatively or in combination, the photo detector 126 may be configured to detect light reflected back through at least one of the first aperture 11OA or the second aperture 11OB. In some alternative embodiments, the layer of breathable tape 11OT may define a single aperture extending from aperture or opening 115.

[0066] Figure 112 A shows a cross-sectional view of the middle portion of embodiments of adherent device 100. In some embodiments, portions of the external housing of the pulse oximeter 121 may extend at least partially through the first aperture 1 IOTA and the second aperture 1 IOTB toward the skin of the patient. Such portions of the external housing of the pulse oximeter 121 define a first light channel 121 A for the first light emitter 124A and a second light channel 12 IB for the second light emitter 124B. The first light channel 121 A and/or the second light channel 12 IB can be hollow. In some embodiments, the first light channel 12 IA and/or the second light channel 12 IB can comprise a clear or substantially optically transmissive material.

[0067] The adherent device comprises electrodes 112 A 1 , 112B 1 , 112C 1 and 112D 1 configured to couple to tissue through apertures in the breathable tape 11OT. Electrodes 112Al, 112Bl, 112Cl and 112Dl can be fabricated in many ways. For example, electrodes 112Al, 112Bl, 112Cl and 112Dl can be printed on the flexible strip 112F, such as silver ink on polyurethane. Breathable tape HOT comprise apertures 180Al, 180Bl, 180Cl and 180Dl. Electrodes 112Al, 112Bl, 112Cl and 112Dl are exposed to the gel through apertures 180Al, 180Bl, 180Cl and 180Dl of breathable tape 11OT. Gel 114A, gel 114B, gel 114C and gel 114D can be positioned over electrodes 112Al, 112Bl, 112Cl and 112Dl and the respective portions of breathable tape HOT proximate apertures 180Al, 180Bl, 180Cl and 180Dl, so as to couple electrodes 112Al, 112Bl, 112Cl and 112Dl to the skin of the patient. The flexible strip 112F comprising the electrodes can extend from under the gel cover to the printed circuit board to connect to the printed circuit boards and/or components supported thereon. For example, flexible strip 112F may comprise flexible connector 122 A to provide strain relief, as described above. [0068] In many embodiments, gel 114A, or gel layer, comprises a hydrogel that is positioned on electrode 112A to provide electrical conductivity between the electrode and the skin. In many embodiments, gel 114A comprises a hydrogel that provides a conductive interface between skin and electrode, so as to reduce impedance between electrode/skin interface. In many embodiments, gel may comprise water, glycerol, and electrolytes, pharmacological agents, such as beta blockers, ace inhibiters, diuretics, steroid for inflammation, antibiotic, antifungal agent. In specific embodiments the gel may comprise cortisone steroid. The gel layer may comprise many shapes, for example, square, circular, oblong, star shaped, many any polygon shapes. In specific embodiments, the gel layer may comprise at least one of a square or circular geometry with a dimension in a range from about .005" to about .100", for example within a range from about .015" - .070", in some embodiments within a range from about .015" - .040", and in specific embodiments within a range from about .020" - .040". In many embodiments, the gel layer of each electrode comprises an exposed surface area to contact the skin within a range from about 100 mmΛ2 to about 1500mmΛ2, for example a range from about 250 mmΛ2 to about 750 mmΛ2, and in specific embodiments within a range from about 350 mmΛ2 to about 650 mmΛ2. Work in relation with embodiments of the present invention suggests that such dimensions and/or exposed surface areas can provide enough gel area for robust skin interface without excessive skin coverage. In many embodiments, the gel may comprise an adhesion to skin, as may be tested with a 1800 degree peel test on stainless steel, of at least about 3 oz/in, for example an adhesion within a range from about 5-10 oz/in.. In many embodiments, a spacing between gels is at least about 5 mm, for example at least about 10mm. Work in relation to embodiments of the present invention suggests that this spacing may inhibit the gels from running together so as to avoid crosstalk between the electrodes. In many embodiments, the gels comprise a water content within a range from about 20% to about 30%, a volume resistivity within a range from about 500 to 2000 ohm-cm, and a pH within a range from about 3 to about 5. [0069] In many embodiments, the electrodes, for example electrodes 112A to 112D, may comprise an electrode layer. A 0.001 " - 0.005" polyester strip with silver ink for traces can extend to silver/silver chloride electrode pads. In many embodiments, the electrodes can provide electrical conduction through hydrogel to skin, and in some embodiments may be coupled directly to the skin. Although at least 4 electrodes are shown, some embodiments comprise at least two electrodes, for example 2 electrodes. In some embodiments, the electrodes may comprise at least one of carbon-filled ABS plastic, silver, nickel, or electrically conductive acrylic tape. In specific embodiments, the electrodes may comprise at least one of carbon-filled ABS plastic, Ag/AgCl. The electrodes may comprise many geometric shapes to contact the skin, for example at least one of square, circular, oblong, star shaped, polygon shaped, or round. In specific embodiments, a dimension across a width of each electrodes is within a range from about 002" to about .050", for example from about .010 to about .040". In many a surface area of the electrode toward the skin of the patient is within a range from about 25mmΛ2 to about 1500mmΛ2 , for example from about 75 mmΛ2 to about 150 mmΛ2. In many embodiments, the electrode comprises a tape that may cover the gel near the skin of the patient. In specific embodiments, the two inside electrodes may comprise force, or current electrodes, with a center to center spacing within a range from about 20 to about 50 mm. In specific embodiments, the two outside electrodes may comprise measurement electrodes, for example voltage electrodes, and a center-center spacing between adjacent voltage and current electrodes is within a range from about 15 mm to about 35 mm. Therefore, in many embodiments, a spacing between inner electrodes may be greater than a spacing between an inner electrode and an outer electrode.

[0070] In many embodiments, adherent patch 110 may comprise a layer of breathable tape 11OT, for example a known breathable tape, such as tricot-knit polyester fabric. In many embodiments, breathable tape 11OT comprises a backing material, or backing 111, with an adhesive. In many embodiments, the patch adheres to the skin of the patient's body, and comprises a breathable material to allow moisture vapor and air to circulate to and from the skin of the patient through the tape. In many embodiments, the backing is conformable and/or flexible, such that the device and/or patch does not become detached with body movement. In many embodiments, backing can sufficiently regulate gel moisture in absence of gel cover. In many embodiments, adhesive patch may comprise from 1 to 2 pieces, for example 1 piece. In many embodiments, adherent patch 110 comprises pharmacological agents, such as at least one of beta blockers, ace inhibiters, diuretics, steroid for inflammation, antibiotic, or antifungal agent. In specific embodiments, patch 110 comprises cortisone steroid. Patch 110 may comprise many geometric shapes, for example at least one of oblong, oval, butterfly, dogbone, dumbbell, round, square with rounded corners, rectangular with rounded corners, or a polygon with rounded corners. In specific embodiments, a geometric shape of patch 110 comprises at least one of an oblong, an oval or round. In many embodiments, the geometric shape of the patch comprises a radius on each corner that is no less than about one half a width and/or diameter of tape. Work in relation to embodiments of the present invention suggests that rounding the corner can improve adherence of the patch to the skin for an extended period of time because sharp corners, for example right angle corners, can be easy to peel. In specific embodiments, a thickness of adherent patch 110 is within a range from about 0.001 " to about .020", for example within a range from about 0.005" to about 0.010". Work in relation to embodiments of the present invention indicates that these ranges of patch thickness can improve adhesion of the device to the skin of the patient for extended periods as a thicker adhesive patch, for example tape, may peel more readily. In many embodiments, length 170 of the patch is within a range from about 2" to about 10", width 174 of the patch is within a range from about 1" to about 5". In specific embodiments, length 170 is within a range from about 4" to about 8" and width 174 is within a range from about 2" to about 4". In many embodiments, an adhesion to the skin, as measured with a 180 degree peel test on stainless steel , can be within a range from about 10 to about 100 oz/in width, for example within a range from about 30 to about 70 oz/in width. Work in relation to embodiments of the present invention suggests that adhesion within these ranges may improve the measurement capabilities of the patch because if the adhesion is too low, patch will not adhere to the skin of the patient for a sufficient period of time and if the adhesion is too high, the patch may cause skin irritation upon removal. In many embodiments adherent patch 110 comprises a moisture vapor transmission rate (MVTR, g/mΛ2/24 hrs) per American Standard for Testing and Materials E-96 (ASTM E-96) is at least about 400, for example at least about 1000. Work in relation to embodiments of the present invention suggest that MVTR values as specified above can provide improved comfort, for example such that in many embodiments skin does not itch. In some embodiments, the breathable tape 11OT of adherent patch 110 may comprise a porosity (sec./lOOcc/in ) within a wide range of values, for example within a range from about 0 to about 200. The porosity of breathable tape 11OT may be within a range from about 0 to about 5. The above amounts of porosity can minimize itching of the patient's skin when the patch is positioned on the skin of the patient. In many embodiments, the MVTR values above may correspond to a MVTR through both the gel cover and the breathable tape. The above MVTR values may also correspond to an MVTR through the breathable tape, the gel cover and the breathable cover. The MVTR can be selected to minimize patient discomfort, for example itching of the patient's skin.

[0071] In some embodiments, the breathable tape may contain and elute a pharmaceutical agent, such as an antibiotic, anti-inflammatory or antifungal agent, when the adherent device is placed on the patient. [0072] In many embodiments, tape 11OT of adherent patch 110 may comprise backing material, or backing 111, such as a fabric configured to provide properties of patch 110 as described above. In many embodiments backing 111 provides structure to breathable tape 11OT, and many functional properties of breathable tape 11OT as described above. In many embodiments, backing 111 comprises at least one of polyester, polyurethane, rayon, nylon, breathable plastic film; woven, nonwoven, spunlace, knit, film, or foam. In specific embodiments, backing 111 may comprise polyester tricot knit fabric. In many embodiments, backing 111 comprises a thickness within a range from about 0.0005" to about 0.020", for example within a range from about 0.005" to about 0.010". [0073] In many embodiments, an adhesive 116A, for example breathable tape adhesive comprising a layer of acrylate pressure sensitive adhesive, can be disposed on underside 11OA of patch 110. In many embodiments, adhesive 116A adheres adherent patch 110 comprising backing 111 to the skin of the patient, so as not to interfere with the functionality of breathable tape, for example water vapor transmission as described above. In many embodiments, adhesive 116A comprises at least one of acrylate, silicone, synthetic rubber, synthetic resin, hydrocolloid adhesive, pressure sensitive adhesive (PSA), or acrylate pressure sensitive adhesive. In many embodiments, adhesive 116A comprises a thickness from about 0.0005" to about 0.005", in specific embodiments no more than about 0.003". Work in relation to embodiments of the present invention suggests that these thicknesses can allow the tape to breathe and/or transmit moisture, so as to provide patient comfort.

[0074] A gel cover 180, or gel cover layer, for example a polyurethane non- woven tape, can be positioned over patch 110 comprising the breathable tape. A PCB layer, for example flex printed circuit board 120, or flex PCB layer, can be positioned over gel cover 180 with electronic components 130 connected and/or mounted to flex printed circuit board 120, for example mounted on flex PCB so as to comprise an electronics layer disposed on the flex PCB layer. In many embodiments, the adherent device may comprise a segmented inner component, for example the PCB may be segmented to provide at least some flexibility. In many embodiments, the electronics layer may be encapsulated in electronics housing 160 which may comprise a waterproof material, for example silicone or epoxy. In many embodiments, the electrodes are connected to the PCB with a flex connection, for example trace 123 A of flex printed circuit board 120, so as to provide strain relive between the electrodes 112A, 112B, 112C and 112D and the PCB. In many embodiments, the gel cover may comprise an optically non-transmissive or opaque material to minimize exposure of the pulse oximeter 121 to external or ambient light. [0075] Gel cover 180 can inhibit flow of gel 114A and liquid. In many embodiments, gel cover 180 can inhibit gel 1 14A from seeping through breathable tape 11OT to maintain gel integrity over time. Gel cover 180 can also keep external moisture from penetrating into gel 114A. For example gel cover 180 can keep liquid water from penetrating though the gel cover into gel 114A, while allowing moisture vapor from the gel, for example moisture vapor from the skin, to transmit through the gel cover. The gel cover may comprise a porosity at least 200 sec./lOOcc/in2, and this porosity can ensure that there is a certain amount of protection from external moisture for the hydrogel.

[0076] In many embodiments, the gel cover can regulate moisture of the gel near the electrodes so as to keeps excessive moisture, for example from a patient shower, from penetrating gels near the electrodes. In many embodiments, the gel cover may avoid release of excessive moisture form the gel, for example toward the electronics and/or PCB modules. Gel cover 180 may comprise at least one of a polyurethane, polyethylene, polyolefin, rayon, PVC, silicone, non- woven material, foam, or a film. In many embodiments gel cover 180 may comprise an adhesive, for example a acrylate pressure sensitive adhesive, to adhere the gel cover to adherent patch 110. In specific embodiments gel cover 180 may comprise a polyurethane film with acrylate pressure sensitive adhesive. In many embodiments, a geometric shape of gel cover 180 comprises at least one of oblong, oval, butterfly, dogbone, dumbbell, round, square, rectangular with rounded corners, or polygonal with rounded corners. In specific embodiments, a geometric shape of gel cover 180 comprises at least one of oblong, oval, or round. In many embodiments, a thickness of gel cover is within a range from aboutθ.0005" to about 0.020", for example within a range from about 0.0005 to about 0.010". In many embodiments, gel cover 180 can extend outward from about 0-20 mm from an edge of gels, for example from about 5-15 mm outward from an edge of the gels. [0077] In many embodiments, the breathable tape of adherent patch 110 comprises a first mesh with a first porosity and gel cover 180 comprises a breathable tape with a second porosity, in which the second porosity is less than the first porosity to inhibit flow of the gel through the breathable tape.

[0078] In many embodiments, device 100 includes a printed circuitry, for example a printed circuitry board (PCB) module that includes at least one PCB with electronics component mounted thereon on and the battery, as described above. In many embodiments, the PCB module comprises two rigid PCB modules with associated components mounted therein, and the two rigid PCB modules are connected by flex circuit, for example a flex PCB. In specific embodiments, the PCB module comprises a known rigid FR4 type PCB and a flex PCB comprising known polyimide type PCB. In specific embodiments, the PCB module comprises a rigid PCB with flex interconnects to allow the device to flex with patient movement. The geometry of flex PCB module may comprise many shapes, for example at least one of oblong, oval, butterfly, dogbone, dumbbell, round, square, rectangular with rounded corners, or polygon with rounded corners. In specific embodiments the geometric shape of the flex PCB module comprises at least one of dogbone or dumbbell. The PCB module may comprise a PCB layer with flex PCB 120 can be positioned over gel cover 180 and electronic components 130 connected and/or mounted to flex PCB 120 so as to comprise an electronics layer disposed on the flex PCB. In many embodiments, the adherent device may comprise a segmented inner component, for example the PCB, for limited flexibility. The printed circuit may comprise polyester film with silver traces printed thereon.

[0079] In many embodiments, the electronics layer may be encapsulated in electronics housing 160. Electronics housing 160 may comprise an encapsulant, such as a dip coating, which may comprise a waterproof material, for example silicone and/or epoxy. In many embodiments, the PCB encapsulant protects the PCB and/or electronic components from moisture and/or mechanical forces. The encapsulant may comprise silicone, epoxy, other adhesives and/or sealants. In some embodiments, the electronics housing may comprising metal and/or plastic housing and potted with aforementioned sealants and/or adhesives. [0080] In many embodiments, the electrodes are connected to the PCB with a flex connection, for example trace 123 A of flex PCB 120, so as to provide strain relive between the electrodes 112A, 112B, 112C and 112D and the PCB. In such embodiments, motion of the electrodes relative to the electronics modules, for example rigid PCB's 120A, 120B, 120C and 120D with the electronic components mounted thereon, does not compromise integrity of the electrode/hydrogel/skin contact. In some embodiments, the electrodes can be connected to the PCB and/or electronics module with a flex PCB 120, such that the electrodes and adherent patch can move independently from the PCB module. In many embodiments, the flex connection comprises at least one of wires, shielded wires, non-shielded wires, a flex circuit, or a flex PCB. In specific embodiments, the flex connection may comprise insulated, non-shielded wires with loops to allow independent motion of the PCB module relative to the electrodes.

[0081] In specific embodiments, cover 162 comprises at least one of polyester, 5-25% elastane/spandex, polyamide fabric; silicone, a polyester knit, a polyester knit without elastane, or a thermoplastic elastomer. In many embodiments cover 162 comprises at least 400% elongation. In specific embodiments, cover 162 comprises at least one of a polyester knit with 10-20% spandex or a woven polyamide with 10-20% spandex. In many embodiments, cover 162 comprises a water repellent coating and/or layer on outside, for example a hydrophobic coating, and a hydrophilic coating on inside to wick moisture from body. In many embodiments the water repellent coating on the outside comprises a stain resistant coating. Work in relation to embodiments of the present invention suggests that these coatings can be important to keep excessive moisture from the gels near the electrodes and to remove moisture from body so as to provide patient comfort.

[0082] In many embodiments, cover 162 can encase the flex PCB and/or electronics and can be adhered to at least one of the electronics, the flex PCB or adherent patch 110, so as to protect at least the electronics components and the PCB. Cover 162 can attach to adherent patch 110 with adhesive 116B. Cover 162 can comprise many known biocompatible cover materials, for example silicone. Cover 162 can comprise an outer polymer cover to provide smooth contour without limiting flexibility. In many embodiments, cover 162 may comprise a breathable fabric. Cover 162 may comprise many known breathable fabrics, for example breathable fabrics as described above. In some embodiments, the breathable cover may comprise a breathable water resistant cover. In some embodiments, the breathable fabric may comprise polyester, nylon, polyamide, and/or elastane (Spandex™) to allow the breathable fabric to stretch with body movement. In some embodiments, the breathable tape may contain and elute a pharmaceutical agent, such as an antibiotic, anti-inflammatory or antifungal agent, when the adherent device is placed on the patient.

[0083] The breathable cover 162 and adherent patch 110 comprise breathable tape can be configured to couple continuously for at least one week the at least one electrode to the skin so as to measure breathing of the patient. The breathable tape may comprise the stretchable breathable material with the adhesive and the breathable cover may comprises a stretchable breathable material connected to the breathable tape, as described above, such that both the adherent patch and cover can stretch with the skin of the patient. The breathable cover may also comprise a water resistant material. Arrows 182 show stretching of adherent patch 110, and the stretching of adherent patch can be at least two dimensional along the surface of the skin of the patient. As noted above, connectors 122 A, 122B, 122C and 122D between PCB 130 and electrodes 112 A, 112B, 112C and 112D may comprise insulated wires that provide strain relief between the PCB and the electrodes, such that the electrodes can move with the adherent patch as the adherent patch comprising breathable tape stretches. Arrows 184 show stretching of cover 162, and the stretching of the cover can be at least two dimensional along the surface of the skin of the patient.

[0084] Cover 162 can be attached to adherent patch 110 with adhesive 116B such that cover 162 stretches and/or retracts when adherent patch 110 stretches and/or retracts with the skin of the patient. For example, cover 162 and adherent patch 110 can stretch in two dimensions along length 170 and width 174 with the skin of the patient, and stretching along length 170 can increase spacing between electrodes. Stretching of the cover and adherent patch 110, for example in two dimensions, can extend the time the patch is adhered to the skin as the patch can move with the skin such that the patch remains adhered to the skin. Electronics housing 160 can be smooth and allow breathable cover 162 to slide over electronics housing 160, such that motion and/or stretching of cover 162 is slidably coupled with housing 160. The printed circuit board can be slidably coupled with adherent patch 110 that comprises breathable tape 11OT, such that the breathable tape can stretch with the skin of the patient when the breathable tape is adhered to the skin of the patient, for example along two dimensions comprising length 170 and width 174.

[0085] The stretching of the adherent device 100 along length 170 and width 174 can be characterized with a composite modulus of elasticity determined by stretching of cover 162, adherent patch 110 comprising breathable tape HOT and gel cover 180. For the composite modulus of the composite fabric cover-breathable tape-gel cover structure that surrounds the electronics, the composite modulus may comprise no more than about IMPa, for example no more than about 0.3MPa at strain of no more than about 5%. These values apply to any transverse direction against the skin.

[0086] The stretching of the adherent device 100 along length 170 and width 174, may also be described with a composite stretching elongation of cover 162, adherent patch 110 comprising breathable tape 11OT and gel cover 180. The composite stretching elongation may comprise a percentage of at least about 10% when 3 kg load is a applied, for example at least about 100% when the 3 kg load applied. These percentages apply to any transverse direction against the skin.

[0087] The printed circuit board may be adhered to the adherent patch 110 comprising breathable tape 11OT at a central portion, for example a single central location, such that adherent patch 110 can stretch around this central region. The central portion can be sized such that the adherence of the printed circuit board to the breathable tape does not have a substantial effect of the modulus of the composite modulus for the fabric cover, breathable tape and gel cover, as described above. For example, the central portion adhered to the patch may be less than about 100 mm2, for example with dimensions of approximately 10 mm by 10 mm (about 0.5" by 0.5"). Such a central region may comprise no more than about 10% of the area of patch 110, such that patch 110 can stretch with the skin of the patient along length 170 and width 174 when the patch is adhered to the patient.

[0088] The cover material may comprise a material with a low recovery, which can minimize retraction of the breathable tape from the pulling by the cover. Suitable cover materials with a low recovery include at least one of polyester or nylon, for example polyester or nylon with a loose knit. The recovery of the cover material may be within a range from about 0% recovery to about 25% recovery. Recovery can refer to the percentage of retraction the cover material that occurs after the material has been stretched from a first length to a second length. For example, with 25% recovery, a cover that is stretched from a 4 inch length to a 5 inch length will retract by 25% to a final length of 4.75 inches.

[0089] Electronics components 130 can be affixed to printed circuit board 120, for example with solder, and the electronics housing can be affixed over the PCB and electronics components, for example with dip coating, such that electronics components 130, printed circuit board 120 and electronics housing 160 are coupled together. Electronics components 130, printed circuit board 120, and electronics housing 160 are disposed between the stretchable breathable material of adherent patch 110 and the stretchable breathable material of cover 160 so as to allow the adherent patch 110 and cover 160 to stretch together while electronics components 130, printed circuit board 120, and electronics housing 160 do not stretch substantially, if at all. This decoupling of electronics housing 160, printed circuit board 120 and electronic components 130 can allow the adherent patch 110 comprising breathable tape to move with the skin of the patient, such that the adherent patch can remain adhered to the skin for an extended time of at least one week, for example two or more weeks.

[0090] An air gap 169 may extend from adherent patch 110 to the electronics module and/or PCB, so as to provide patient comfort. Air gap 169 allows adherent patch 1 10 and breathable tape 11OT to remain supple and move, for example bend, with the skin of the patient with minimal flexing and/or bending of printed circuit board 120 and electronic components 130, as indicated by arrows 186. Printed circuit board 120 and electronics components 130 that are separated from the breathable tape HOT with air gap 169 can allow the skin to release moisture as water vapor through the breathable tape, gel cover, and breathable cover. This release of moisture from the skin through the air gap can minimize, and even avoid, excess moisture, for example when the patient sweats and/or showers.

[0091] The breathable tape of adherent patch 110 may comprise a first mesh with a first porosity and gel cover 180 may comprise a breathable tape with a second porosity, in which the second porosity is less than the first porosity to minimize, and even inhibit, flow of the gel through the breathable tape. The gel cover may comprise a polyurethane film with the second porosity.

[0092] Cover 162 may comprise many shapes. In many embodiments, a geometry of cover 162 comprises at least one of oblong, oval, butterfly, dogbone, dumbbell, round, square, rectangular with rounded corners, or polygonal with rounded corners. In specific embodiments, the geometric of cover 162 comprises at least one of an oblong, an oval or a round shape.

[0093] Cover 162 may comprise many thicknesses and/or weights. In many embodiments, cover 162 comprises a fabric weight: within a range from about 100 to about 200 g/mΛ2, for example a fabric weight within a range from about 130 to about 170 g/mΛ2. [0094] In many embodiments, coverl62 can attach the PCB module to adherent patch 110 with cover 162, so as to avoid interaction of adherent patch HOC with the PCB having the electronics mounted therein. Cover 162 can be attached to breathable tape HOT and/or electronics housing 160 comprising over the encapsulated PCB. In many embodiments, adhesive 116B attaches cover 162 to adherent patch 110. In many embodiments, cover 162 attaches to adherent patch 110 with adhesive 116B, and cover 162 is adhered to the PCB module with an adhesive 161 on the upper surface of the electronics housing. Thus, the PCB module can be suspended above the adherent patch via connection to cover 162, for example with a gap 169 between the PCB module and adherent patch. In many embodiments, gap 169 permits air and/or water vapor to flow between the adherent patch and cover, for example through adherent patch 110 and cover 162, so as to provide patient comfort.

[0095] In many embodiments, adhesive 116B is configured such that adherent patch 110 and cover 162 can be breathable from the skin to above cover 162 and so as to allow moisture vapor and air to travel from the skin to outside cover 162. In many embodiments, adhesive 116B is applied in a pattern on adherent patch 110 such that the patch and cover can be flexible so as to avoid detachment with body movement. Adhesive 116B can be applied to upper side 11OB of patch 110 and comprise many shapes, for example a continuous ring, dots, dashes around the perimeter of adherent patch 110 and cover 162. Adhesive 116B may comprise at least one of acrylate, silicone, synthetic rubber, synthetic resin, pressure sensitive adhesive (PSA), or acrylate pressure sensitive adhesive. Adhesive 16B may comprise a thickness within a range from about 0.0005" to about 0.005", for example within a range from about .001 - .005". In many embodiments, adhesive 116B comprises a width near the edge of patch 110 and/or cover 162 within a range from about 2 to about 15 mm , for example from about 3 to about 7 near the periphery. In many embodiments with such widths and/or thickness near the edge of the patch and/or cover, the tissue adhesion may be at least about 30 oz/in, for example at least about 40 oz/in, such that the cover remains attached to the adhesive patch when the patient moves.

[0096] In many embodiments, the cover is adhered to adherent patch 110 comprising breathable tape 11OT at least about 1 mm away from an outer edge of adherent patch 110. This positioning protects the adherent patch comprising breathable tape HOT from peeling away from the skin and minimizes edge peeling, for example because the edge of the patch can be thinner. In some embodiments, the edge of the cover may be adhered at the edge of the adherent patch, such that the cover can be slightly thicker at the edge of the patch which may, in some instances, facilitate peeling of the breathable tape from the skin of the patient.

[0097] Gap 169 extend from adherent patch 110 to the electronics module and/or PCB a distance within a range from about 0.25 mm to about 4 mm, for example within a range from about 0.5 mm to about 2 mm.

[0098] In many embodiments, the adherent device comprises a patch component and at least one electronics module. The patch component may comprise adherent patch 110 comprising the breathable tape with adhesive coating 116A, at least one electrode, for example electrode 114A and gel 114. The at least one electronics module can be separable from the patch component. In many embodiments, the at least one electronics module comprises the flex printed circuit board 120, electronic components 130, electronics housing 160 and cover 162, such that the flex printed circuit board, electronic components, electronics housing and cover are reusable and/or removable for recharging and data transfer, for example as described above. In many embodiments, adhesive 116B is coated on upper side 11OA of adherent patch 11OB, such that the electronics module can be adhered to and/or separated from the adhesive component. In specific embodiments, the electronic module can be adhered to the patch component with a releasable connection, for example with Velcro™, a known hook and loop connection, and/or snap directly to the electrodes. Two electronics modules can be provided, such that one electronics module can be worn by the patient while the other is charged, as described above. Monitoring with multiple adherent patches for an extended period is described in U.S. Pat. App. No. 60/972,537 ', the full disclosure of which has been previously incorporated herein by reference. Many patch components can be provided for monitoring over the extended period. For example, about 12 patches can be used to monitor the patient for at least 90 days with at least one electronics module, for example with two reusable electronics modules. [0099] In many embodiments, the adherent device comprises a patch component and at least one electronics module. The patch component may comprise adherent patch 110 comprising the breathable tape with adhesive coating 116A, at least one electrode, for example electrode 114A and gel 114. The at least one electronics module can be separable from the patch component. In many embodiments, the at least one electronics module comprises the flex printed circuit board 120, electronic components 130, electronics housing 160 and cover 162, such that the flex printed circuit board, electronic components, electronics housing and cover are reusable and/or removable for recharging and data transfer, for example as described above. In many embodiments, adhesive 116B is coated on upper side 11OA of adherent patch 11OB, such that the electronics module can be adhered to and/or separated from the adhesive component. In specific embodiments, the electronic module can be adhered to the patch component with a releasable connection, for example with Velcro™, a known hook and loop connection, and/or snap directly to the electrodes. Two electronics modules can be provided, such that one electronics module can be worn by the patient while the other is charged, as described above. Monitoring with multiple adherent patches for an extended period is described in U.S. Pat. App. No. 60/972,537, the full disclosure of which has been previously incorporated herein by reference. Many patch components can be provided for monitoring over the extended period. For example, about 12 patches can be used to monitor the patient for at least 90 days with at least one electronics module, for example with two reusable electronics modules.

[0100] At least one electrode 112A can extend through at least one aperture 180A in the breathable tape 110 and gel cover 180.

[0101] In some embodiments, the adhesive patch may comprise a medicated patch that releases a medicament, such as antibiotic, beta-blocker, ACE inhibitor, diuretic, or steroid to reduce skin irritation. The adhesive patch may comprise a thin, flexible, breathable patch with a polymer grid for stiffening. This grid may be anisotropic, may use electronic components to act as a stiffener, may use electronics-enhanced adhesive elution, and may use an alternating elution of adhesive and steroid. [0102] Figure IK shows at least one electrode 190 configured to electrically couple to a skin of the patient through a breathable tape 192. In many embodiments, at least one electrode 190 and breathable tape 192 comprise electrodes and materials similar to those described above. Electrode 190 and breathable tape 192 can be incorporated into adherent devices as described above, so as to provide electrical coupling between the skin an electrode through the breathable tape, for example with the gel.

[0103] Figures 2A to 2C show a schematic illustration of a system 200 to monitor a patient for an extended period. Figure 2A shows a schematic illustration of system 200 comprising a reusable electronics module 210 and a plurality of disposable patch components comprising a first disposable patch component 220A, a second disposable patch component 220B, a third disposable patch component 220C and a fourth disposable patch component 220D. Although four patch components a shown the plurality may comprise as few as two patch component and as many as three or more patch components, for example 25 patch components.

[0104] Figure 2B shows a schematic illustration of a side cross-sectional view of reusable electronics module 210. Reusable electronics module 210 may comprises many of the structures described above that may comprise the electronics module. In many embodiments, reusable electronics module 210 comprises a PCB, for example a flex PCB 212, pulse oximeter 213, electronics components 216, batteries 216, and a cover 217, for example as described above. In some embodiments, reusable electronics module 210 may comprise an electronics housing over the electronics components and/or PCB as described above. The electronics components may comprise circuitry and/or sensors for measuring pulse oximetry signals, ECG signals, hydration impedance signals, respiration impedance signals and accelerometer signals, for example as described above. In many embodiments, reusable electronics module 210 comprises a connector 219 adapted to connect to each of the disposable patch components, sequentially, for example one disposable patch component at a time. Connector 219 can be formed in many ways, and may comprise known connectors as described above, for example a snap. In some embodiments, the connectors on the electronics module and adhesive component can be disposed at several locations on the reusable electronics module and disposable patch component, for example near each electrode, such that each electrode can couple directly to a corresponding location on the flex PCB of the reusable electronics component.

[0105] Alternatively or in combination with batteries 216, each of the plurality of disposable patch components may comprise a disposable battery. For example first disposable patch component 220A may comprise a disposable battery 214 A; second disposable patch component 220B may comprise a disposable battery 214B; third disposable patch component 220C may comprise a disposable battery 214C; and a fourth disposable patch component 220D may comprise a disposable battery 214D. Each of the disposable batteries, 214A, 214B, 214C and 214D may be affixed to each of disposable patches 220A, 220B, 220C and 220D, respectively, such that the batteries are adhered to the disposable patch component before, during and after the respective patch component is adhered to the patient. Each of the disposable batteries, 214A, 214B, 214C and 214D may be coupled to connectors 215A, 215B, 215C and 215D, respectively. Each of connectors 215A, 215B, 215C and 215D can be configured to couple to a connector of the reusable module 220, so as to power the reusable module with the disposable battery coupled thereto. Each of the disposable batteries, 214A, 214B, 214C and 214D may be coupled to connectors 215A, 215B, 215C and 215D, respectively, such that the batteries are not coupled to the electrodes of the respective patch component, so as to minimize, and even avoid, degradation of the electrodes and/or gel during storage when each disposable battery is adhered to each respective disposable patch component. [0106] Figure 2C shows a schematic illustration first disposable patch component 220A of the plurality of disposable patch components that is similar to the other disposable patch components, for example second disposable patch component 220B, third disposable patch component 220C and fourth disposable patch component 220C. The disposable patch component comprises a breathable tape 227A, an adhesive 226A on an underside of breathable tape 227A to adhere to the skin of the patient, and at least four electrodes 222A. The at least four electrodes 224A are configured to couple to the skin of a patient, for example with a gel 226A, in some embodiments the electrodes may extend through the breathable tape to couple directly to the skin of the patient with aid form the gel. In some embodiments, the at least four electrodes may be indirectly coupled to the skin through a gel and/or the breathable tape, for example as described above. A connector 229A on the upper side of the disposable adhesive component can be configured for attachment to connector 219 on reusable electronics module 210 so as to electrically couple the electrodes with the electronics module. The upper side of the disposable patch component may comprise an adhesive 224A to connect the disposable patch component to the reusable electronics module. The reusable electronics module can be adhered to the patch component with many additional known ways to adhere components, for example with Velcro™ comprising hooks and loops, snaps, a snap fit, a lock and key mechanisms, magnets, detents and the like. [0107] Figure 2D shows a method 250 of using system 200, as in Figures 2A to 2C. A step 252 adheres electronics module 210 to first disposable adherent patch component 220A of the plurality of adherent patch components and adheres the first disposable patch component to the skin of the patient, for example with the first adherent patch component adhered to the reusable electronics module. A step 254 removes the first disposable adherent patch from the patient and separates first disposable adherent patch component 220A from reusable electronics module 210. A step 256 adheres electronics module 210 to second disposable adherent patch component 220B and adheres the second disposable patch component to the skin of the patient, for example with the second adherent patch component adhered to the reusable electronics module. A step 258 removes the second disposable adherent patch from the patient and separates second disposable adherent patch component 220B from reusable electronics module 210. A step 260 adheres electronics module 210 to third disposable adherent patch component 220C and adheres the third disposable patch component to the skin of the patient, for example with the third adherent patch component adhered to the reusable electronics module. A step 262 removes the third disposable adherent patch from the patient and separates third disposable adherent patch component 220C from reusable electronics module 210. A step 264 adheres electronics module 210 to fourth disposable adherent patch component 220D and adheres the fourth disposable patch component to the skin of the patient, for example with the third adherent patch component adhered to the reusable electronics module. A step 268 removes the fourth disposable adherent patch from the patient and separates fourth disposable adherent patch component 220D from reusable electronics module 210.

[0108] In many embodiments, physiologic signals, for example ECG, hydration impedance, respiration impedance and accelerometer impedance are measured when the adherent patch component is adhered to the patient, for example when any of the first, second, third or fourth disposable adherent patches is adhered to the patient.

[0109] Figures 3A to 3F show a method of manufacturing embodiments of the adherent device.

[0110] As shown in Figures 3A and 3Al, the electrodes 112Al, 112Bl, 112Cl and 112Dl are printed on the flexible strip 112F, for example, by printing silver ink on polyurethane. Figures 3 A and 3Al show a top view and a side, cross-sectional view of the electrodes 112Al, 112Bl, 112Cl and 112Dl printed onto the flexible strip 112F. The flexible strip 112F may comprise a flexible connector 112A coupled to a flexible PCB positioned or mounted over the electrodes as described above. [0111] As shown in Figures 3B and 3Bl, the pulse oximeter 121, including the first light emitter 124A , the second light emitter 124B, and the photo detector 126, are coupled to the flexible strip 112F. Figures 3B and 3Bl show a top view and a side cross-sectional view, respectively, of the pulse oximeter 121 coupled to the flexible strip 112F. In many embodiments, the pulse oximeter is disposed between electrode 112A2 and electrode 112A3. In many embodiments, circuitry of the pulse oximeter 121 is coupled to at least one conductive element in flexible strip 112F so that signals from the pulse oximeter 121 can be transmitted to and from the coupled flexible PCB as described above.

[0112] As shown in Figures 3C and 3Cl, a gel cover 180 as described above can then be coupled to flexible strip 112F and the pulse oximeter 121. Figure 3C and 3Cl show a top view and a side view, respectively, of the gel cover 180 coupled to flexible strip 112F and the pulse oximeter 121.

[0113] As shown in Figures 3D and 3Dl, a breathable tape HOT can be molded on the under side of the gel cover 180, the pulse oximeter 121, and the flexible strip 112F. Figure 3D and 3Dl show a top view and a side view, respectively, of the molded breathable tape 11OT. As shown in Figure 3Dl, the electrodes 112Al, 112A2, 112A3, and 112A4 and portions of the housing of the pulse oximeter 121 can form indentations on the breathable tape 11OT. These indentations correspond to each of the electrodes 112Al, 112A2, 112A3, and 112A4, the first light emitter 124A, the second light emitter 124B, and the photo detector 126. [0114] Figures 3El and 3E2 show side cross-sectional views of the molded breathable tape 11OT with the indentations. As shown in Figure 3El, the breathable tape 11OT can be cut in accordance to the location of the indentations, i.e., apertures can be formed on the breathable tape HOT along the dotted lines. As shown in Figure 3E2, aperture 180Al, aperture 180A2, aperture 180A3, aperture 180A4, aperture 110TA, first aperture HOTA, second aperture 110TB, and a photodetector aperture 1 IOTC can thereby be formed on the breathable tape 11OT.

[0115] Figure 3E3 shows a top view of the breathable tape 11OT with aperture 180Al, aperture 180A2, aperture 180A3, aperture 180A4, aperture HOTC, first aperture 110TA, second aperture 110TB, and photo detector aperture 1 IOTC. The aperture 1 IOTC, the first aperture 1 IOTA, and the second aperture 1 IOTC are shown as arrange along the central, longitudinal axis of the adherent device 100. Other arrangements, for example, as described herein with reference to Figures IB to 1B3, may also be used. [0116] Figure 3F shows a the breathable tape 11OT coupled to the under side of the gel cover 180, the pulse oximeter 121, and the flexible strip 112F. The apertures 180Al, 180A2, 180A3, and 180A4 of the breathable tape 11OT respectively correspond to the electrodes 112Al, 112A2, 112A3, and 112A4. In many embodiments, at least a part of the electrodes 112Al, 112A2, 112A3, and 112A4 may extend through at least a portion of the apertures 180Al, 180A2, 180A3, and 180A4 respectively. The first aperture 1 IOTA and the second aperture of the breathable tape HOT respectively correspond to the first light emitter 124 A and the second light emitter 124B of the pulse oximeter 121. The photo detector aperture 1 IOTC corresponds to the photo detector 126 of the pulse oximeter 121. In many embodiments, at least a part of the first light emitter 124A, the second light emitter 124B, and the photo detector 121 of the pulse oximeter 121 may extend through at least a portion of the first aperture 1 IOTA, the second aperture 110TB, and the photo detector aperture 1 IOTC respectively.

[0117] As described above, a cover 162 can be placed over the PCB, the flexible strip 112F, the electrodes 112Al, 112A2, 112A3, 112A4, the pulse oximeter 121, the gel cover 180, and the breathable tape 11OT to complete the adherent patch 100. In some embodiments, a liner can be placed on the under side of the adherent patch 100 to protect the electrodes 112Al, 112A2, 112A3, 112A4 and the pulse oximeter 121, for example, to protect the adherent patch 100 before it is adhered on the skin of a patient.

[0118] It should be appreciated that the specific steps illustrated in Figures 3 A to 3E provide a particular method of manufacturing an adherent patch monitoring a patient for an extended period, according to an embodiment of the present invention. Other sequences of steps may also be performed according to alternative embodiments. For example, alternative embodiments of the present invention may perform the steps outlined above in a different order. Moreover, the individual steps illustrated in Figures 3A to 3E may include multiple sub-steps that may be performed in various sequences as appropriate to the individual step. Furthermore, additional steps may be added or removed depending on the particular applications. One of ordinary skill in the art would recognize many variations, modifications, and alternatives.

[0119] Figures 4A to 4F show a method of manufacturing embodiments of the adherent device. [0120] Figure 4A shows a side view of the flexible strip 112F comprising electrodes 112Al, 112Bl, 112Cl and 112Dl. [0121] Figure 4B shows a side view of the flexible strip 112F of Figure 4A further coupled with additional electrodes. A first light emitter electrode 124AE, a second light emitter electrode 124BE, and a photo detector electrode 126E are coupled to the flexible strip 112F. For example, the first light emitter electrode 124AE, the second light emitter electrode 124BE, and the photo detector electrode 126E may be printed on the flexible strip 112F.

[0122] Figure 4C shows a side view of the flexible strip 112F of Figure 4B further coupled with the light emitters and photo detectors to form an oximeter. The first light emitter 124A is coupled to the first light emitter electrode 124AE. The second light emitter 124B is coupled to the second light emitter electrode 124AE. The photo detector 126 is coupled to the photo detector electrode 126E. The first light emitter electrode 124AE, the second light emitter electrode 124BE, the photo detector 126E and the corresponding first light emitter 124A, second light emitter 124B, and photo detector 126 can be arranged in many ways, for example, as described herein with reference to Figures IB to 1B3.

[0123] Figure 4D shows a side view of the flexible strip 112F of Figure 4C further coupled to the middle of tape 11OT, which may comprise a housing formed around the first light emitter

124A, the second light emitter 124B, and the photo detector 126. Apertures 1 IOTA, 110TB, and 1 IOTC as described above can be formed on the middle of tape 11OT. The middle of tape HOT may comprise a non-optically transmissive material. In some embodiments, the majority of the middle of the tape HOT may comprise a non-optically transmissive material while portions of the middle of the tape 11OT disposed directly under the light emitters and photo detectors comprise an optically transmissive material.

[0124] Figure 4E shows a side view of the flexible strip 112F of Figure 4D further coupled to a layer of adhesive 116 A. The layer of adhesive 116A is optically transmissive.

[0125] Figure 4F shows a side view of the flexible strip 112F of Figure 4F further coupled to a gel cover 180. The gel cover 180 may comprise a non-optically transmissive material to serve as an opaque backing to block out external or ambient light.

[0126] It should be appreciated that the specific steps illustrated in Figures 4A to 4F provide a particular method of manufacturing an adherent patch monitoring a patient for an extended period, according to an embodiment of the present invention. Other sequences of steps may also be performed according to alternative embodiments. For example, alternative embodiments of the present invention may perform the steps outlined above in a different order. Moreover, the individual steps illustrated in Figures 4A to 4F may include multiple sub-steps that may be performed in various sequences as appropriate to the individual step. Furthermore, additional steps may be added or removed depending on the particular applications. One of ordinary skill in the art would recognize many variations, modifications, and alternatives.

[0127] EXPERIMENTAL CLINICAL STUDY [0128] A clinical study can be conducted under a protocol similar to that described in U.S. App. No. 12/209,288, entitled "Adherent Device with Multiple Physiological Sensors" filed September 12, 2008, so as to measure signals from actual patients with an adherent device and to determine parameters of the adherent patch device. The study can be conducted on an empirical number of patient and the parameters of the patch, for example materials parameters and circuitry parameters, can be determined empirically such that the adherent device can be configured to adhere continuously for at least one week and monitor the patient. These data may also show that 90 day continuous in home monitoring can be achieved with a set of 13 patches in which one of the patches is replaced each week. Therefore, a device, as described above, can be made by one of ordinary skill in the art based on the teachings described herein for extended monitoring of 90 days or more.

[0129] While the exemplary embodiments have been described in some detail, by way of example and for clarity of understanding, those of skill in the art will recognize that a variety of modifications, adaptations, and changes may be employed. Hence, the scope of the present invention should be limited solely by the appended claims.

Claims

WHAT IS CLAIMED IS:
1. An adherent device to monitor a patient having a skin, the device comprising: an oximeter comprising a first photo emitter, a second photo emitter and a photo detector; at least two electrodes comprising a first electrode and a second electrode; and a breathable support comprising an adhesive configured to adhere to the skin of the patient to couple the oximeter to the skin.
2. The adherent device of claim 1 wherein the support comprises a substantially non-optically transmissive material configured to adhere to the skin to inhibit external light transmission through the support to the skin.
3. The adherent device of claim 2, wherein the first electrode and the second electrode are spaced apart to define an electrode measurement axis and wherein the first photo emitter and the second photo emitter are spaced apart from the photo detector to define an optical measurement path and wherein the optical measurement path extends substantially along the electrode measurement axis to minimize interference from external light.
4. The adherent device of claim 3 wherein the first photo emitter, the second photo emitter and the photo detector are each disposed along the electrode measurement axis.
5. The adherent device of claim 3 wherein the first photo emitter is disposed on a first side of the electrode measurement axis and the second photo emitter is disposed on a second side of the electrode measurement axis opposite the first side.
6. The adherent device of claim 3 wherein the first emitter is separated from the second emitter by an emitter separation distance and wherein a maximum distance from the first emitter or the second emitter to the photo detector is at least about five times the emitter separation distance.
7. The adherent device of claim 1, wherein the support comprises a first at least one oximeter opening sized to receive the oximeter to couple the oximeter to the skin when the support is adhered to the skin.
8. The adherent device of claim 7, wherein the first at least one oximeter opening is sized to receive a housing of the oximeter.
9. The adherent device of claim 7, wherein the first at least one oximeter opening comprises a first opening sized to couple the first photo emitter and the second photo emitter to the skin and a second opening sized to couple the photo detector to the skin.
10. The adherent device of claim 1 wherein the support comprises a first electrode opening to couple the first electrode to the skin and a second electrode opening to couple the second electrode to the skin.
11. The adherent device of claim 1 further comprising a flexible strip coupled to the support, the flexible strip comprising a lower side oriented toward the breathable tape and an upper side oriented away from the breathable tape, wherein the at least two electrodes are disposed on the side surface of the strip.
12. The adherent device of claim 11 wherein the first emitter, the second emitter and the photo detector are each disposed on the lower side of the strip to couple to the skin.
13. The adherent device of claim 11 wherein the first emitter comprises a first vertical-cavity surface-emitting laser (VCSEL) configured to emit visible light and the second emitter comprises a second vertical-cavity surface-emitting laser (VCSEL) configured to emit near infrared light.
14. The adherent device of claim 11 wherein the first emitter comprises a first LED configured to emit visible light and the second emitter comprises a second LED configured to emit near infrared light.
15. The adherent device of claim 11 wherein the first emitter and the second emitter are soldered to a lower surface of the lower side of the strip at a base and extend no more than about 3 mm from the lower side toward the skin to minimize irritation to the skin.
16. The adherent device of claim 11 wherein the housing comprises a first at least one channel to pass light from at least one of the first emitter or the second emitter to the skin, the housing comprising a second at least one channel configured to pass light from the skin to the photo detector, wherein the housing extends no more than about 5 mm from a base affixed the strip to the a distal end configured to contact the skin to minimize irritation of the skin when the support is adhered to the skin.
17. The adherent device of claim 11 wherein the first emitter, the second emitter and the photo detector are each disposed on the upper side of the strip and wherein a housing extends from the upper side through an opening in the strip and an opening in the support to couple each of the first emitter, the second emitter and the photo detector to the skin.
18. The adherent device of claim 11 further comprising a gel cover disposed over the strip to affix the strip to the support.
19. The adherent device of claim 18 wherein the gel cover comprises a substantially non-optically transmissive material affixed to the support to inhibit external light transmission through the gel cover to the skin.
20. The adherent device of claim 18 further comprising a printed circuit board disposed over the gel cover and coupled to the flexible strip with a connector to provide strain relief between the printed circuitry board and the support and allow the support to stretch without substantial interference from the printed circuit board and wherein the printed circuit board comprises a substantially non-optically transmissive material to inhibit external light transmission through the printed circuit board to the skin.
21. The adherent device of claim 18 further comprising cover disposed over the gel cover, the cover coupled to the support along an outer portion of the support such that the cover is configured to stretch with the support when the support is adhered to the skin.
22. The adherent device of claim 21 wherein the cover comprises a substantially non-optically transmissive material disposed over the support to inhibit external light transmission through the cover to the skin.
23. The adherent device of claim 1 wherein the oximeter comprises a housing, the housing having a first at least one channel to pass light from at least one of the first photo emitter or the second photo emitter to the skin, the housing having a second at least one channel to pass light from the skin to the photo detector, wherein the housing extends from the support toward the skin between the first channel and the second channel to couple the housing to the skin when the support is adhered to the skin.
24. The adherent device of claim 23 wherein the housing comprises a low durometer elastomer to minimize irritation to the skin.
25. The adherent device of claim 23 wherein the housing comprises an opaque material to inhibit light transmission through the housing.
26. The adherent device of claim 25 wherein the first at least one channel and the second at least one channel comprise an optically transmissive material to transmit light therethrough.
27. The adherent device of claim 25 wherein the first at least one channel and the second are hollow to transmit light through the channel.
28. The adherent device of claim 1 further comprising a processor comprising a tangible medium supported with the support and coupled to the oximeter to determine oxygen of the patient.
29. The adherent device of claim 28 wherein the processor is configured to measure oxygen of the patient with a duty cycle of the first photo emitter and the second photo emitter of no more than about 10 percent.
30. The adherent device of claim 29 wherein the processor is configured to measure oxygen of the patient with a duty cycle of the first photo emitter and the second photo emitter of no more than about 5 percent.
31. The adherent device of claim 30 wherein the processor is configured to measure oxygen of the patient with a duty cycle of the first photo emitter and the second photo emitter of no more than about 1 percent.
32. The adherent device of claim 31 wherein the processor is configured to measure oxygen with a sampling frequency of no more than about 70 Hz.
33. The adherent device of claim 28 further comprising an accelerometer and wherein the processor coupled to the oximeter, the accelerometer and at least two electrodes and wherein the processor is configured to suppress noise from the oximeter in response to an accelerometer signal.
34. The adherent device of claim 28 wherein the processor comprising the tangible medium is configured to measure respiration of the patient in response to a signal of the oximeter.
35. A method of monitoring a patient comprising a skin, the method comprising: adhering an adherent device to the skin of the patient, the adherent device comprising a support with an adhesive coupled to an oximeter and at least two electrodes, wherein the at least two electrodes and the oximeter are coupled to the skin of the patient when the support is adhered to the skin of the patient.
36. The method of claim 35 wherein an optical path of the oximeter is substantially aligned with a measurement axis of the at least two electrodes.
37. The method of claim 35 wherein the adherent device comprises an accelerometer and wherein noise from the oximeter is suppressed in response to a signal from the accelerometer.
38. A method of manufacturing an adherent device configured to measure patient data, the method comprising: printing a conductive material on a flexible strip; coupling a first emitter, a second emitter and a detector to the conductive material disposed on the electrode strip; molding a housing around the first emitter, the second emitter and the detector such that the housing is affixed to the strip; and forming holes in a support comprising an adhesive sized to receive the housing; and placing the flexible strip in contact with the adhesive material such that the housing extends at least partially through the holes.
39. The method of claim 38 wherein the conductive material printed on the strip comprises a first electrode and a second electrode.
40. The method of claim 39 wherein the housing is affixed to the support between the first electrode and the second electrode.
41. The method of claim 38 further comprising placing a gel cover comprising an adhesive over the flexible strip and the support comprising the adhesive to affix the flexible strip to the support.
42. The method of claim 38 wherein the flexible strip comprises an elongate connector sized to extend with a loop to a printed circuit board positioned over the first electrode and wherein the conductive material is printed on the connector to couple the electrodes with the printed circuit board.
43. The method of claim 42 wherein a cover is placed over the printed circuit board and connected to the support near a periphery of the support such that the cover stretches with the support and the gel cover.
44. The method of claim 42 wherein one or more of the support, the gel cover or the cover comprises an optically non-transmissive material.
45. The method of claim 42 wherein the support comprises a corresponding opening for each electrode sized to couple to a gel pad placed along a lower surface of the support and wherein the gel pad is positioned over each corresponding electrode.
46. The method of claim 45 wherein a liner is positioned over the lower surface of the support to protect the gel pads and the oximeter.
PCT/US2010/027663 2009-03-17 2010-03-17 Adherent device with oximeter and physiological sensors WO2010107913A2 (en)

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