WO2010105203A2 - Method and apparatus for elder care monitoring - Google Patents

Method and apparatus for elder care monitoring Download PDF

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Publication number
WO2010105203A2
WO2010105203A2 PCT/US2010/027202 US2010027202W WO2010105203A2 WO 2010105203 A2 WO2010105203 A2 WO 2010105203A2 US 2010027202 W US2010027202 W US 2010027202W WO 2010105203 A2 WO2010105203 A2 WO 2010105203A2
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data
elder
skin
patient
elder person
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PCT/US2010/027202
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French (fr)
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WO2010105203A3 (en
Inventor
Yatheendhar D. Manicka
Imad Libbus
Richard Fogoros
Mark J. Bly
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Corventis, Inc.
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Publication of WO2010105203A2 publication Critical patent/WO2010105203A2/en
Publication of WO2010105203A3 publication Critical patent/WO2010105203A3/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring 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
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4869Determining body composition
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring 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
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/01Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02438Detecting, measuring or recording pulse rate or heart rate with portable devices, e.g. worn by the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Cardiology (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

An adherent device configured to adhere to the skin of the elder and measure data with two or more sensors to measure patient data. The patient data can be transmitted with wireless communication circuitry, such that the patient can be monitored and subtle changes in physiology can be detected such that appropriate action may be taken. The patient data from two or more sensors can be combined to determine the status of the patient. For example, hydration data can be combined with activity data to determine a status of the elder person, and transmit a notification to friend to monitor compliance with medication and a notification to a physician to diagnose the mental health of the elder.

Description

METHOD AND APPARATUS FOR ELDER CARE MONITORING
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application claims the benefit under 35 USC 119(e) of US Provisional Application No. 61/159,638 filed March 12, 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 elder person monitoring. Although embodiments make specific reference to monitoring impedance and electrocardiogram signals with an adherent patch device, the systems, methods, and devices described herein may be applicable to many applications in which physiological monitoring is used, for example wireless physiological monitoring for extended periods.
[0003] People like to live healthy and independent lives. Unfortunately, people age. As people age, the physiological and mental status can slowly deteriorate. For example, an elder person may not have the full mental or physical capabilities that were present earlier in life. In at least some instances an elder person may be weaker, prone to falls, and may suffer from bed sores due to inactivity and/or insufficient nutrition. An elder person may suffer from senility, may not remember to take medications, and may become disoriented in at least some instances. At some point, at least some level of assistance may be needed.
[0004] Elder persons are often treated for diseases and/or conditions associated with the compromised physical or mental status of the elder person. Unfortunately, in at least some instances, an elder person may not report symptoms, such that diagnosis and treatment may be delayed until a catastrophic event in at least some instances. For example, an elder person may not be able to report fainting or dizziness that requires diagnosis, due to a decreased mental status of the elder person. Also, an elder person may be prone to falls, and in at least some instances the elder person may not be able to get up after a fall for an extended time. Although social networks can be established to check up on people, intervention of a friend or family member may not occur as quickly as would be ideal.
[0005] In at least some instances an elder person may be place in a long term care facility, such as a convalescent hospital. Although such a long term care facility may provide better care than an elder person might receive at home, improvements would be helpful. Long term care facilities can be expensive, and people in such facilities may still be injured in at least some instances. In at least some instances an elder person who is bed ridden may fall trying to get out of bed and/or suffer from bed sores.
[0006] Although long term monitoring of the elder person can provide useful information, work in relation to embodiments of the present invention suggests that known methods and apparatus for long term monitoring of elder persons may be less than ideal in at least some instances. At least some of the known devices may not collect the right kinds of data to treat elder persons optimally. For example, although successful at detecting and storing electrocardiogram signals, devices such as the Holter monitor can be somewhat bulky and may not collect all of the kinds of data that would be ideal to diagnose and/or treat an elder person. In at least some instances, devices that are worn by the elder person may be somewhat uncomfortable, which may lead to elder persons not wearing the devices and not complying with direction from the health care provider, such that data collected may be less than ideal. In at least some instances, an elder person may have a skin condition and/or a weaker skin, for example with bedsores, such the adherence of at least some known devices to the skin of the elder person for physiological monitoring may result in irritation to the skin of the elder person in at least some instances. Although implantable devices may be used in some instances, many of these devices can be invasive and/or costly, and may suffer at least some of the shortcomings of known wearable devices.
[0007] Therefore, a need exists for improved elder person monitoring. Ideally, such improved elder person monitoring would avoid at least some of the short-comings of the present methods and devices.
[0008] 2. Description of the Background Art. The following U.S. Patents and Publications may describe relevant background art: 2008/0294020; 2008/0294019; 2008/0059239; 2008/0024294; 2007/0142715; 2007/0010721; 2005/0228244; 2002/0123672; 7,468,032; 7,206,630; 6,871,211; and 6,858,006. SUMMARY OF THE INVENTION
[0009] The present invention relates to elder person monitoring. Although embodiments make specific reference to monitoring an elder person 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.
[0010] The systems, devices and methods described herein in accordance with embodiments of the present invention can provide improved care of an elder person. An adherent device can be configured to adhere to the skin of the elder and configured to measure data of the elder person, for example data from two or more sensors such as activity data and hydration data. The data can be transmitted with wireless communication circuitry, such that the patient can be monitored and subtle changes in physiology can be detected such that appropriate action may be taken before the condition of the elder person deteriorates. The transmitted patient data may be used in many ways to determine the status of the patient. The patient data can be transmitted to an online social network that allows family members, care givers, physicians and similarly situated elders to monitor the elder person. The patient data from two or more sensors can be combined to determine the status of the patient. Hydration data can be combined with activity data to determine a status of the elder person, and transmit a notification to friend to monitor compliance with medication and a notification to a physician to diagnose the mental health of the elder. Accelerometer data can be combined with orientation data to determine that a bed ridden patient is attempting to get out of bed and trigger an alarm, for example based on measured tremor and orientation of the elder. A support and a cover of the adherent device can be configured to stretch with the skin of the elder so as to minimize trauma to the elder skin, for example with at least one of an adhesive, a percent elongation and a modulus of elasticity of the support and the cover.
[0011] In a first aspect, embodiments of the invention provide a device to monitor an elder person having a skin. The device comprises a support, two or more sensors, and circuitry coupled to the two or more sensors. The support comprises an adhesive configured to adhere to the skin. The support is configured to stretch with the skin when adhered to the skin. The two or more sensors are configured to measure data from the elder person. The two or more sensors are coupled to the support to support the sensors with the skin when the support is adhered to the skin. The circuitry is configured to transmit the data from the elder person. The circuitry is coupled to the support to support the circuitry with the skin when the support is adhered to the skin.
[0012] In many embodiments, the two or more sensors are configured to measure two or more of hydration data, activity data, respiration data, heart rate data, orientation data, temperature data, blood oxygen data or sound data. The two or more sensors may be configured to measure the hydration data with impedance circuitry, the activity data with an accelerometer, the respiration data with impedance circuitry, the heart rate data with ECG circuitry, the orientation data with the accelerometer, the temperature data with temperature circuitry, blood oxygen data with pulsed oximeter circuitry or the sound data with microphone circuitry. The two or more sensors may be configured to measure the hydration data and the activity data, and the circuitry may be configured to combine the hydration data and the activity data and transmit a notification based on the hydration data and the activity data. In some embodiments, the circuitry is configured to determine a mental status of the elder person in response to the hydration data combined with the activity data, and the notification corresponds to the mental status of the elder person.
[0013] In many embodiments, the sound data comprises internal sounds from within the elder person and external sounds from outside the elder person. In some embodiments, the circuitry is configured to measure and transmit the elder person's voice in response to a command from the elder person. The adherent device further may comprise a speaker coupled to the adherent support, and the circuitry may comprise two way wireless communication circuitry such that the elder person can speak with far end speaker. The circuitry may be configured to pair with at least one of a cell phone or a gateway and establish a connection with the far end speaker in response to the user command. The circuitry may be configured to pair with the at least one of the cell phone or the gateway and establish the connection with the far end speaker in response to one or more of a fall, a cardiac arrhythmia, a dehydration, an edema, a syncope, a respiratory distress, a bed sore risk, a prolonged inactivity, a stress, a respiratory distress, or a fever.
[0014] In some embodiments, the adherent device is configured to adhere to communicate to a similar adherent device with peer to peer communication.
[0015] In another aspect, embodiments of the invention provide a method of monitoring an elder person having a skin. A support comprising an adhesive is adhered to the skin. The support stretches with the skin when adhered to the elder skin. Data is measured from the elder person with two or more sensors. The two or more sensors are supported with the skin when the support is adhered to the skin. The data is transmitted from the elder person with circuitry. The circuitry is coupled to the support such that the circuitry is supported with the skin when the data are transmitted.
[0016] In another aspect, embodiments of the invention provide a system to care for an elder person having a skin. The system comprises an adherent device and a gateway. The adherent device comprises a support configured to adhere to the skin. The adherent device comprises two or more sensors configured to measure data when the support is adhered to the skin. The gateway is configured to communicate with the adherent device. The system may comprise one or more of a processor of the adherent device, a processor of the gateway or a processor of a remote server. The processor system is configured to determine a status of the elder person.
[0017] In many embodiments, the processor system comprises a tangible medium having instructions of a computer program embodied thereon such that the processor system is configured to determine the status of the patient.
[0018] In many embodiments, the processor system is configured to determine at least one of an over sedation or an agitation of the elder person. The processor system may be configured to combine two or more of activity data, hydration data, orientation data, heart rate data or respiration data to determine the over sedation or the agitation of the elder person.
[0019] In many embodiments, the processor system is configured to determine a fall of the patient. The processor system may be configured to combine two or more of activity data, hydration data, orientation data, hear rate data or respiration data to determine the fall of the elder person.
[0020] In many embodiments, the processor system is configured to determine an attempt of the elder person to get out of a bed. The user comprises a bed ridden patient and the processor system is configured to determine the attempt based on one or more of a tremor of the activity data, an orientation change toward upright of the orientation data, an increase in heart rate of the heart rate data or an increase in respiration of respiration of the respiration data. The processor system may be configured to combine two or more of the activity data, the hydration data, the orientation data, the heart rate data or the respiration data to determine the attempt of the elder person.
[0021] In many embodiments, the processor system is configured to determine a risk of the elder person to a decubitus ulcer and issue at least one of a notification, an alert or an alarm in response to the risk. The processor system may be configured to determine the risk based on the activity data and the orientation data. The processor system may be configured to determine the risk based on an amount of time a surface of the elder person is oriented toward a bed. The elder person may comprise at least one of a bed ridden patient or an ambulatory patient.
[0022] In many embodiments, the processor system is configured to receive as input one or more locations of one or more decubitus ulcers and issue a notification based on the patient orientation data and the locations of the one or more decubitus ulcers.
[0023] In many embodiments, the processor system is configured to receive as input a target activity amount of the elder person. The processor system is configured to issue at least one of a notification, an alert or an alarm in response to patient activity data corresponding to patient activity below the target activity amount.
[0024] In many embodiments, the processor system is configured to store first elder person activity comprising an activity baseline and compare the activity baseline with the activity data to determine a change in activity from baseline. The processor system is configured to issue an alert when the change in activity from baseline exceeds an amount.
[0025] In many embodiments, the processor system is configured to store an activity profile of the patient corresponding to at least one week of activity data. The processor system is configured to display the activity profile to a user.
[0026] In many embodiments, the processor system is configured to determine a REM sleep of the user based on the activity data. In some embodiments, the processor system may be configured to determine the REM sleep of the user based on one or more frequencies of movement of the activity data, wherein the one or more frequencies of movement correspond to a time when the patient is asleep.
[0027] In some embodiments, the processor system is configured to combine two or more of activity data, hydration data, orientation data, heart rate data or respiration data to determine a sleep status of the patient. The sleep status may comprise a sleep quality. [0028] In many embodiments, the processor system is configured to combine two or more of activity data, hydration data, orientation data, heart rate data or respiration data to determine a swoon of the patient. The processor system may be configured to determine the swoon based on prolonged immobility. The processor system may be configured to determine the swoon based an orientation the patient and a location of the patient within the home. The system may further comprise a triangulation system to determine the location of the patient within the home.
[0029] In many embodiments, the system further comprises a robotic aide configured to receive, store and respond to the elder persons vital signs.
[0030] In many embodiments, the gateway is configured to couple to a processor system comprising an online social network. The gateway is configured to transmit the data to the social network such that where network members can view the status of the elder. The gateway may be configured to communicate with substantially similar gateways with a peer to peer communication protocol to couple the elder person with another elder person wearing a substantially similar adherent device.
[0031] In another aspect, embodiments of the invention provide a device to monitor an elder person having an elder skin. The device comprises a support, two or more sensors, and circuitry coupled to the two or more sensors. The support comprises an adhesive configured to adhere to the elder skin. The support is configured to stretch with the elder skin when adhered to the elder skin. The two or more sensors configured to measure data from the elder person. The two or more sensors are coupled to the support to support the sensors with the elder skin when the support is adhered to the elder skin. The circuitry is configured to transmit the data from the elder person. The circuitry is coupled to the support to support the circuitry with the elder skin when the support is adhered to the elder skin.
[0032] In many embodiments, the circuitry comprises a processor comprising a tangible medium coupled to the two or more sensors to measure and process the data. The circuitry comprises wireless communication circuitry coupled to the processor and configured transmit the data.
[0033] In many embodiments, the device further comprises a cover coupled to an outer portion of the support. The cover is configured to stretch with the support when the elder skin stretches to minimize stress to the elder skin. [0034] In many embodiments, the support is configured to adhere continuously to the elder skin for at least about one week without substantial irritation of the elder skin. The support can be configured to adhere continuously to the elder skin with one or more of adhesion strength, peel strength, skin contact adhesion, breathability, percent elongation or strain.
[0035] In another aspect, embodiments of the invention provide a method of monitoring an elder person having an elder skin. An adherent device is adhered to the elder skin. The data of the elder person is measured when the device is adhered to the elder skin such that sensors of the adherent device are coupled to the elder skin. The data is transmitted with wireless communication circuitry supported with the elder skin.
[0036] In many embodiments, the patch adheres continuously to the elder skin for at least about one week without substantial irritation of the elder skin. A cover of the patch and a support are configured with one or more of adhesion strength, peel strength, skin contact adhesion, breathability, percent elongation or strain, such that the support the cover stretch with the elder skin.
[0037] In many embodiments, a deterioration of the elder person is determined based on the data transmitted.
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] Figure IA shows an elder person and a monitoring system comprising an adherent device, according to embodiments of the present invention;
[0039] Figure IB shows a bottom view of the adherent device as in Figure IA comprising an adherent patch;
[0040] Figure 1C shows a top view of the adherent patch, as in Figure IB;
[0041] Figure ID shows a printed circuit boards and electronic components over the adherent patch, as in Figure 1C;
[0042] Figure IDl shows an equivalent circuit that can be used to determine optimal frequencies for determining elder person hydration, according to embodiments of the present invention; [0043] Figure 1D2 shows adherent devices as in Figs. 1 A-ID positioned on a patient to determine orientation of the adherent patch on the patient, according to embodiments of the present invention;
[0044] Figure 1D3 shows vectors from a 3D accelerometer to determine orientation of the measurement axis of the patch adhered on the patient, according to embodiments of the present invention;
[0045] Figure IE shows batteries positioned over the printed circuit board and electronic components as in Figure ID;
[0046] 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;
[0047] Figure IG shows a side view of the adherent device as in Figures IA to IF;
[0048] Figure IH shown a bottom isometric view of the adherent device as in Figures IA to IG;
[0049] 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;
[0050] 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;
[0051] Figure IK shows at least one electrode configured to electrically couple to a skin of the l elder person through a breathable tape, according to embodiments of the present invention;
[0052] Figures 2A to 2C show a system to monitor an elder person for an extended period comprising a reusable electronic component and a plurality of disposable patch components, according to embodiments of the present invention;
[0053] Figure 2D shows a method of using the system as in Figures 2A to 2C;
> [0054] Figures 3 A to 3D show a method of monitoring an elder person for an extended period with an adherent patch with adherent patches alternatively adhered to the right side or the left side of the elder person; [0055] Figure 4A shows measurement signals, according to embodiments of the present invention;
[0056] Figure 4Al shows accelerometer signals for orientations for an accelerometer of adherent device on the patient;
[0057] Figure 4A2 shows orientation of the thorax of the patient that can be determined in response to signals as in Fig. 4Al; and
[0058] Figure 5 shows a method of monitoring an elder person, in accordance with embodiments of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0059] Embodiments of the present invention comprise a system to monitor of the elderly persons and others who require additional care, for example handicapped younger persons. The system can be used with persons who are independent enough to avoid assisted living. The system may also be used by assisted living and nursing home facilities as a way to expand monitoring of residents and provide feedback of resident condition and status to family members.
[0060] In many embodiments, a system is configured for monitoring an elder person in a home or assisted living setting with one or more devices adhered to the elder person. The system can monitor vital signs and provide alarms based on detected events. In many embodiments, the system is also configured to detect subtle changes in elder person physiology and send a notification to a caregiver, in which the notification indicates that the elder person is to be carefully diagnosed by a qualified physician. For example a subtle decrease in elder person activity and a subtle decrease in hydration can indicate a change in the mental status of the elder person, and a notification to the physician can be sent indicating that the mental status of the elder person is to be diagnosed. Changes in elder person's activity and hydration can also be related to compliance with medications, and a notification can be sent to one or more of a friend, family member or care giver to determine whether the elder person has taken medications properly.
[0061] In many embodiments, a kit with instructions is configured for sale as a consumer product consisting of a single reusable, rechargeable electronic module that connects to a replaceable adherent base, which can allow family members or friends to more closely monitor an elder person, for example without supervision of a physician. The components of the kit can be configured to interface with an online social network, in which similarly situated elder persons can assist each other. A social network for the elderly may comprise for example, a first elderly person being assigned to regularly check-up on or monitor a second elderly person and vice versa, at regular time intervals, for example, every other day. The social network may also be configured such that members can log visits, such that accountability can be maintained.
[0062] The adherent device can be configured adhere to the elder person's chest, and configured to monitor one or more of the following physiological parameters: electrocardiogram, heart rate, respiratory rate, activity, posture, body temperature, body fluid, heart sounds or blood oximetry.
[0063] Event detection can be coupled with one or more of notification, alert or alarming features. For example, alarming events can be either automatically detected or user activated with an elder person trigger. The system may have the capability to alert family, caregivers, and emergency response (e.g. 911) in the event of an emergency. Events that can be detected may include one or more of the following: cardiac arrhythmias, hydration (dehydration, edema, body fluid), falls, syncope, respiratory distress, activity, bed sore risk (based on prolonged inactivity/movement), stress, respiratory distress, fever.
[0064] Elder person data such as vital sign trends and arrhythmia statistics (PVCs, PACs, AF Burden, arrhythmia logbook) can be stored, summarized, and provided to one or more of the physician, caregiver or family through a web site interface.
[0065] The adherent device may comprise a microphone for monitoring of heart and lung sounds. Such a microphone can be tuned to the appropriate frequencies for physiological monitoring, and may be configured with a voice-activated trigger. The adherent device may also comprise a speaker to allow the monitored elder person to communicate with one or more of a friend, a family member, a remote caregiver or a physician.
[0066] The system can be configured incorporate elder person's status into an online social network, where network members can provide oversight and accountability.
[0067] The adherent device comprises wireless communication circuitry, for example configured to communicate with a robotic aid, which aid can be configured receive, store, and respond to the elder person's vital signs. [0068] 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 elder person and support the electronics and sensors on the elder person. The support can be porous and breathable so as to allow water vapor transmission. The support can also stretch with skin of the elder person, so as to improve elder person comfort and extend the time that the support can be adhered to the elder person. The support may be configured to continuously adhere to the skin of the elder person for at least one week, with the peel adhesion and strength and contact strength configured such that the support does not injure the skin of the elder when removed. The support and structures mounted thereon can be configured for continuous adhesion for one week, for example with a support configured to stretch with the skin of the elder person to minimize folding and wrinkles formed in the support. The support can also be configured to breath such that water vapor is transmitted and the integrity of the elder skin is maintained such that trauma to the skin of the elder is minimized.
[0069] 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 elder person comfort, such that the adherent patch can be worn and/or tolerated by the elder person 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. 12/209,288, entitled "Adherent Device with Multiple Physiological Sensors", filed on September 12, 2008, and 12/209,273, entitled "Adherent Device with Multiple Physiological Sensors", filed on September 12, 2008. In many embodiments, the adherent patch comprises a tape, which comprises a material, preferably breathable, with an adhesive, such that trauma to the elder person 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 elder person to provide improved elder person comfort.
[0070] Figure IA shows an elder person P and a monitoring system 10. Elder person P comprises a midline M, a first side Sl, 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 an elder person P at many locations, for example thorax T of elder person P. In many embodiments, the adherent device may adhere to one side of the elder person, from which side data can be collected. Work in relation with embodiments of the present invention suggests that location on a side of the elder person can provide comfort for the elder person while the device is adhered to the elder person.
[0071] 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 elder person, for example in the same town as the elder person, and can be located as far from the elder person as a separate continent from the elder person, for example the elder person 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 elder person 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 processor 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 108A with a communication system 107A, 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 elder person P with a communication, for example with a two way communication system, as indicated by arrow 109 A, for example by cell phone, email, or 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 elder person 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 elder person as indicated by arrow 109C. Thus, in many embodiments, monitoring system 10 comprises a closed loop system in which elder person care can be monitored and implemented from the remote center in response to signals from the adherent device.
[0072] 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 elder person'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 elder person's home. In some embodiments, remote center 106 receives the elder person data and applies an elder person evaluation algorithm, for example the prediction algorithm to predict elder physiological or mental deterioration. In some embodiments, the algorithm may comprise an algorithm to predict impending elder physiological or mental deterioration, for example based on decreased hydration and activity. When a flag is raised, the center may communicate with the elder person, hospital, nurse, and/or physician to allow for therapeutic intervention, for example to prevent further physiological or mental deterioration.
[0073] 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.
[0074] 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 101A 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 elder person.
[0075] 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, heart rate variability (HRV), heart rate turbulence (HRT), heart sounds (e.g. S3), respiratory sounds, blood pressure, activity, posture, wake/sleep, orthopnea, temperature/heat flux, and weight. 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.
[0076] 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.
[0077] In many embodiments, instructions are transmitted from remote site 106 to a processor supported with the adherent patch on the elder person, and the processor supported with the elder person can receive updated instructions for the elder person treatment and/or monitoring, for example while worn by the elder person.
[0078] 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 1 1OA, that is oriented toward the skin of the elder person when placed on the elder person. In many embodiments, adherent patch 110 comprises a tape 11OT which is a material, preferably breathable, with an adhesive 116 A. Elder person side 11OA comprises adhesive 116A to adhere the patch 110 and adherent device 100 to elder person P. Electrodes 112 A, 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 elder person. Gel 114A, gel 114B, gel 114C and gel 114D can each be positioned over electrodes 112A, 112B, 112C and 112D, respectively, to provide electrical conductivity between the electrodes and the skin of the elder person. 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.
[0079] 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 HOB. In many embodiments, electrodes 112 A, 112B, 112C and 112D extend from lower side 11OA through adherent patch 110 to upper side 11OB. 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 elder person. The PCB may comprise completely flex PCB, rigid PCB, rigid PCB combined flex PCB and/or rigid PCB boards connected by cable.
[0080] 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, 1 12B, 1 12C and 112D with connectors 122A, 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 122 A, 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 122 A, 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. Examples of structures to provide strain relief are also described in U.S. Pat. App. No. 12/209,288, entitled "Adherent Device with Multiple Physiological Sensors", filed on September 12, 2008. 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. [0081] 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 elder person, 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.
[0082] Electronics circuitry 130 may comprise a temperature sensor, for example a thermistor in contact with the skin of the elder person, and temperature sensor circuitry 144 to measure a temperature of the elder person, for example a temperature of the skin of the elder person. A temperature sensor may be used to determine the sleep and wake state of the elder person. The temperature of the elder person can decrease as the elder person goes to sleep and increase when the elder person wakes up.
[0083] 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 elder person 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 elder person, for example deeper tissues in the thorax.
[0084] 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 comprises a distributed processor system, for example with multiple processors on device 100.
[0085] 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.
[0086] 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.
[0087] 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 elder person in three dimensions. Work in relation to embodiments of the present invention suggests that three dimensional orientation of the elder person 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.
[0088] 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 112D may comprise sense electrodes. The voltage measured by the sense electrodes can be used to measure the impedance of the elder person and determine the respiration rate and/or hydration of the elder person. The electrocardiogram circuitry may be coupled to the sense electrodes to measure the electrocardiogram signal, for example as described in U.S. Pat. App. No. 12/209,288, entitled "Adherent Device with Multiple Physiological Sensors", filed on September 12, 2008.
[0089] Figure IDl shows an equivalent circuit 152 that can be used to determine optimal frequencies for measuring elder person 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 elder person 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 elder physiological or mental physiological or mental deterioration, 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 elder person hydration.
[0090] In many embodiments, impedance circuitry 136 can be configured to determine respiration of the elder person. 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.
[0091] ECG circuitry 138 can generate electrocardiogram signals and data from two or more of electrodes 112A, 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.
[0092] Figure 1D2 shows an adherent device, for example adherent device 100, positioned on patient P to determine orientation of the adherent patch. X-axis 112X of device 100 is inclined at an angle α to horizontal axis Px of patient P. Z-axis 112Z of device 100 is inclined at angle α to vertical axis Pz of patient P. Y-axis 112Y may be inclined at a second angle, for example α, to anterior posterior axis Py and vertical axis Pz. As the accelerometer of adherent device 100 can be sensitive to gravity, inclination of the patch relative to axis of the patient can be measured, for example when the patient stands.
[0093] ECG circuitry 138 can be coupled to the electrodes in many ways to define an electrocardiogram vector. For example electrode 112A can be coupled to a positive amplifier terminal of ECG circuitry 138 and electrode 112D can be coupled to a negative amplifier terminal of ECG circuitry 138 to define an orientation of an electrocardiogram vector along the electrode measurement axis. To define an electrocardiogram vector with an opposite orientation electrode 112D can be couple to the positive amplifier terminal of ECG circuitry 138 and electrode 112A can be coupled to the negative amplifier terminal of ECG circuitry 138. The ECG circuitry may be coupled to the inner electrodes so as to define an ECG vector along a measurement axis of the inner electrodes.
[0094] Figure 1D3 shows vectors from a 3D accelerometer to determine orientation of the measurement axis of the patch adhered on the patient. The orientation can be determined for each patch adhered to the patient. A Z-axis vector 112ZV can be measured along vertical axis 112Z with an accelerometer signal from axis 134Z of accelerometer 134A. An X-axis vector 112XV can be measured along horizontal axis 112X with an accelerometer signal from axis 134X of accelerometer 134A. Inclination angle α can be determined in response to X-axis vector 112XV and Z- axis vector 112ZV, for example with vector addition of X-axis vector 112XV and Z- axis vector 112ZV. An inclination angle α for the patch along the Y and Z axes can be similarly obtained an accelerometer signal from axis 134 Y of accelerometer 134 A and vector 112ZV.
[0095] 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.
[0096] 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.
[0097] 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.
[0098] 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).
[0099] 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).
[0100] 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.
[0101] Figures 111 and Ul 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. In these embodiments, gel cover 180 extends over a wider area than in the embodiments shown in Figures II and IJ. 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 elder person. 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. [0102] 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 a flexible connector 112F, such as silver ink on polyurethane. Breathable tape 11OT 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 HOT. 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 11OT proximate apertures 180Al, 180Bl, 180Cl and 180Dl, so as to couple electrodes 1 12Al, 112Bl, 112Cl and 112Dl to the skin of the elder person. The flexible connector 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 connector 112F may comprise flexible connector 122 A to provide strain relief, as described above.
[0103] 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 mmA2, 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.
[0104] 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 elder person 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 elder person. 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.
[0105] 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 elder person's body, and comprises a breathable material to allow moisture vapor and air to circulate to and from the skin of the elder person 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 comer 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 elder person 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 elder person 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/in2) within a wide range of values, for example within a range from about 0 to about 200. The porosity of breathable tape HOT may be within a range from about 0 to about 5. The above amounts of porosity can minimize itching of the elder person's skin when the patch is positioned on the skin of the elder person. 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 elder person discomfort, for example itching of the elder person's skin.
[0106] 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 elder person.
[0107] 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 1 11 comprises at least one of polyester, polyurethane, rayon, nylon, breathable plastic film; woven, nonwoven, spun lace, 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".
[0108] In many embodiments, an adhesive 116 A, 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 elder person, 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 elder person comfort.
[0109] 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 112 A, 112B, 112C and 112D and the PCB.
[0110] Gel cover 180 can inhibit flow of gel 114A and liquid. In many embodiments, gel cover 180 can inhibit gel 114A 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.
[0111] In many embodiments, the gel cover can regulate moisture of the gel near the electrodes so as to keeps excessive moisture, for example from an elder person 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.
[0112] 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.
[0113] 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 elder person 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. [0114] 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.
[0115] 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.
[0116] 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 elder person comfort.
[0117] 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 elder person.
[0118] 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 elder person. 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 elder person. 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 elder person. As noted above, connectors 122A, 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 elder person.
[0119] 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 elder person. For example, cover 162 and adherent patch 110 can stretch in two dimensions along length 170 and width 174 with the skin of the elder person, 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 elder person when the breathable tape is adhered to the skin of the elder person, for example along two dimensions comprising length 170 and width 174.
[0120] 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.
[0121] 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 1 10 comprising breathable tape 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.
[0122] 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 elder person along length 170 and width 174 when the patch is adhered to the elder person.
[0123] 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.
[0124] 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 elder person, 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.
[0125] An air gap 169 may extend from adherent patch 110 to the electronics module and/or PCB, so as to provide elder person comfort. Air gap 169 allows adherent patch 110 and breathable tape 11OT to remain supple and move, for example bend, with the skin of the elder person 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 11OT 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 elder person sweats and/or showers.
[0126] 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.
[0127] 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.
[0128] 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.
[0129] In many embodiments, coverl62 can attach the PCB module to adherent patch 110 with cover 162, so as to avoid interaction of adherent patch 11OC with the PCB having the electronics mounted therein. Cover 162 can be attached to breathable tape 11OT 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 elder person comfort.
[0130] 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 elder person moves.
[0131] 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 elder person.
[0132] ' 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.
[0133] 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 elder person 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 02 patches can be used to monitor the elder person for at least 90 days with at least one electronics module, for example with two reusable electronics modules.
[0134] 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 elder person 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 elder person for at least 90 days with at least one electronics module, for example with two reusable electronics modules.
[0135] At least one electrode 112A can extend through at least one aperture 180A in the breathable tape 110 and gel cover 180.
[0136] 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. [0137] Figure IK shows at least one electrode 190 configured to electrically couple to a skin of the elder person 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.
[0138] Figures 2A to 2C show a schematic illustration of a system 200 to monitor an elder person 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.
[0139] 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, 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 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.
[0140] 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 214A; 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 elder person. 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.
[0141] 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 227 A, an adhesive 226A on an underside of breathable tape 227 A to adhere to the skin of the elder person, and at least four electrodes 222A. The at least four electrodes 224A are configured to couple to the skin of an elder person, 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 elder person 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. [0142] 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 elder person, 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 elder person 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 elder person, 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 elder person 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 elder person, 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 elder person 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 elder person, 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 elder person and separates fourth disposable adherent patch component 220D from reusable electronics module 210.
[0143] 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 elder person, for example when any of the first, second, third or fourth disposable adherent patches is adhered to the elder person.
[0144] Figures 3A to 3D show a method 300 of monitoring an elder person for an extended period with adherent patches alternatively adhered to a right side 302 and a left side 304 of the elder person. Work in relation to embodiments of the present invention suggests that repeated positioning of a patch at the same location can irritate the skin and may cause elder person discomfort. This can be avoided by alternating the patch placement between left and right sides of the elder person, often a front left and a front right side of the elder person where the elder person can reach easily to replace the patch. In some embodiments, the patch location can be alternated on the same side of the elder person, for example higher and/or lower on the same side of the elder person without substantial overlap to allow the skin to recover and/or heal. In many embodiments, the patch can be symmetrically positioned on an opposite side such that signals may be similar to a previous position of the patch symmetrically disposed on an opposite side of the elder person. In many embodiments, the duration between removal of one patch and placement of the other patch can be short, such that any differences between the signals may be assumed to be related to placement of the patch, and these differences can be removed with signal processing.
[0145] In many embodiments each patch comprises at least four electrodes configured to measure an ECG signal and impedance, for example hydration and/or respiration impedance. In many embodiments, the elder person comprises a midline 306, with first side, for example right side 302, and second side, for example left side 304, symmetrically disposed about the midline. A step 310 adheres a first adherent patch 312 to at a first location 314 on a first side 302 of the elder person for a first period of time, for example about 1 week. While the adherent patch 312 is position at first location 314 on the first side of the elder person, the electrodes of the patch are coupled to the skin of the elder person to measure the ECG signal and impedance signals.
[0146] A step 320 removes patch 312 and adheres a second adherent patch 322 at a second location 324 on a second side 206 of the elder person for a second period of time, for example about 1 week. In many embodiments, second location 324 can be symmetrically disposed opposite first location 314 across midline 304, for example so as to minimize changes in the sequential impedance signals measured from the second side and first side. While adherent patch 322 is position at second location 324 on the second side of the elder person, the electrodes of the patch are coupled to the skin of the elder person to measure the ECG signal and impedance signals. In many embodiments, while adherent patch 322 is positioned at second location 324, skin at first location 314 can heal and recover from adherent coverage of the first patch. In many embodiments, second location 324 is symmetrically disposed opposite first location 314 across midline 304, for example so as to minimize changes in the impedance signals measured between the first side and second side. In many embodiments, the duration between removal of one patch and placement of the other patch can be short, such that any differences between the signals may be assumed to be related to placement of the patch, and these differences can be removed with signal processing. [0147] A step 330 removes second patch 322 and adheres a third adherent patch 332 at a third location 334 on the first side, for example right side 302, of the elder person for a third period of time, for example about 1 week. In many embodiments, third location 334 can be symmetrically disposed opposite second location 324 across midline 304, for example so as to minimize changes in the sequential impedance signals measured from the third side and second side. In many embodiments, third location 334 substantially overlaps with first location 314, so as to minimize differences in measurements between the first adherent patch and third adherent patch that may be due to patch location. While adherent patch 332 is positioned at third location 334 on the first side of the elder person, the electrodes of the patch are coupled to the skin of the elder person to measure the ECG signal and impedance signals. In many embodiments, while adherent patch 332 is positioned at third location 334, skin at second location 324 can heal and recover from adherent coverage of the second patch. In many embodiments, the duration between removal of one patch and placement of the other patch can be short, such that any differences between the signals may be assumed to be related to placement of the patch, and these differences can be removed with signal processing.
[0148] A step 340 removes third patch 332 and adheres a fourth adherent patch 342 at a fourth location 344 on the second side, for example left side 306, of the elder person for a fourth period of time, for example about 1 week. In many embodiments, fourth location 344 can be symmetrically disposed opposite third location 334 across midline 304, for example so as to minimize changes in the sequential impedance signal measured from the fourth side and third side. In many embodiments, fourth location 344 substantially overlaps with second location 324, so as to minimize differences in measurements between the second adherent patch and fourth adherent patch that may be due to patch location. While adherent patch 342 is positioned at fourth location 344 on the second side of the elder person, the electrodes of the patch are coupled to the skin of the elder person to measure the ECG signal and impedance signals. In many embodiments, while adherent patch 342 is positioned at fourth location 324, skin at third location 334 can heal and recover from adherent coverage of the third patch. In many embodiments, the duration between removal of one patch and placement of the other patch can be short, such that any differences between the signals may be assumed to be related to placement of the patch, and these differences can be removed with signal processing.
[0149] It should be appreciated that the specific steps illustrated in Figures 3A to 3D provide a particular method of monitoring an elder person for an extended period, in accordance with an embodiment of the present invention. Other sequences of steps may also be performed in accordance with 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 3D 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.
[0150] I. Nursing home/ chronic assisted care facility/ hospice
[0151] Assisted care and/or hospice patients can be institutionalized because they are too ill or too feeble to entirely care for themselves. These patients may require daily care that may range from a simple "check-in" once or twice a day (for patients who routinely self-care) to fairly intensive round-the-clock care. At least some of these patients may be institutionalized with the aim of eventually being discharged to home-based care. At least some other patients may need to be institutionalized permanently. Adherent patches and the processor system as described herein may be configured to monitor the following:
[0152] 1.1 Monitoring agitation vs. over sedation
[0153] Elderly institutionalized patients often become periodically confused or agitated, and as a result they may frequently receive sedatives. In at least some instances, these patients may become over sedated. In at least some instances, some patients may cycle between states of agitation and over sedation. Agitation may lead to a patient harming themselves, e.g., through a fall, and/or harming others. Over sedation may lead to decubitus ulcers from lack of movement, aspiration, and/or dehydration.
[0154] Work in relation to embodiments of the present invention suggests actigraphy can be applied in the systems and adherent patches described herein to assist in monitoring patients for both agitation and over sedation. For example, actigraphy may be used to provide measurements of a patient's thorax and/or limb movements at regular intervals or substantially continuously. These measurements may be correlated with the observed activity of the patient and with subjective scores on an agitation or sedation scale. Further, the adherent device and processor system can be configured for actigraphic monitoring of movement and rest-activity rhythms in aging, Alzheimer's disease, and Parkinson's disease. The processor system can be configured to apply digital filtering to an actigraphy measurement signal so as to distinguish between different types and/or of movement.
[0155] In some embodiments, known methods of actigraphy and agitation determination can be combined with additional sensor measurements. For example, changes in breathing patterns, such as the development of Cheyne-Stokes respiration, can be combined with patient data comprising at least one of activity data, hydration data, or electrocardiogram data so as to detect over sedation and trigger an alert.
[0156] 1.2 Fall prevention and fall detection
[0157] The systems and adherent patches as described herein may be used to prevent falls. Fall prevention may be based on actigraphy as described above. Actigraphy may be applied to detect agitation and/or detect efforts by the patients who should remain bedridden to get out of bed, and an alert sent so as to notify staff to intervene. The processor system can be configured for fall detection so that immediate help can be given if a patient has fallen.
[0158] 1.3 Decubitus ulcer prevention
[0159] Decubitus ulcers may result from a patient failing to shift his/her weight for a prolonged period of time (e.g., several hours), thus creating pressure-related skin breakdown. Decubitus ulcers may occur in patients who have neurological problems (such as paraplegia or stroke), diabetes, or disorders of consciousness (obtundation, coma, over sedation). The processor system coupled to the adherent patch devices as described herein may be used to monitor changes in posture and may be configured to alert a medical professional when a patient is at risk of developing decubitus ulcers. The medical professional may then shift the patients weight so that the occurrence of decubitus ulcers may be minimized or even avoided. For example, the processor system can be configured to integrate the time a patient lays on a skin surface, and trigger an alter based on the integral.
[0160] 1.4 Activity monitoring and documentation
[0161] In at least some instances, it can be helpful for elderly patients, including those who are institutionalized, to remain as active as possible. The systems and adherent patches described herein may be configured to keep track of a patient's general level of activity over time. This processor system coupled to the adherent patch devices can be configured to track patient activity and inform medical professionals, staff and friends to encourage specific patients to be more active, and may also assist in identifying patients whose medical condition may be subtly deteriorating.
[0162] 1.5. Sleep quality
[0163] The adherent devices coupled to the processor system can be configured to determine sleep quality. Elderly patients, including those who are institutionalized, may have sleep disorders that can be determined and detected with the adherent devices coupled to the processor system so as to assess sleep quality, and diagnose the cause of sleep disorders. The processor system can be configured to detect one or more of sleep apnea, sleep movement disorders or disorders of circadian rhythm. Detected problems with circadian rhythm may be used by the processor system to trigger an alter for a physician to diagnose the patient..
[0164] 1.6. Monitoring for dehydration
[0165] In elderly patients, overmedication, infection, mental status changes and/or the inability to move can overwhelm the physiological mechanisms that maintain adequate hydration. A patient who becomes dehydrated for these reasons may be unable to feel (or express) thirst, and his or her dehydration may go undetected. The adherent devices coupled to processor systems as described herein can be configured to determine changes in hydration monitoring and detect dehydration. The processor system can be configured to combine hydration patient data with additional patient data to determine a status of the patient. For example, a patient with decreased hydration coupled with decreased activity can be caused by a decreased mental status such as a stroke, and the processor system coupled to the patches configured to determine the decreased mental status of the patient in response to the decreased hydration and activity.
[0166] II. Elderly living alone
[0167] The systems and adherent devices described herein may comprise a consumer product available to people living at home. An elderly person can be somewhat feeble, and may not be at the point where he or she needs to be (or are willing to be) institutionalized. Such an elder person may live alone or with an equally elderly spouse, such that their loved ones may be concerned about their safety. The adherent devices coupled to the processor system can be configured to couple the elders and family members to a social network, such family members, friends and similarly situated elders can remain in contact. [0168] The adherent devices coupled to the processor system can be configured to detect and send out an alter alert in response to the elder person having a stroke, becoming immobilized and not being able to summon help; an elderly person developing the flu, staying in bed for an extended period, for example two or more days, and becoming dehydrated. The alters coupled to the social network can provide intervention so as to minimize organ failure, decubitus ulcers, the elderly person becoming confused, taking too much sedative (or too much diuretic), becoming over sedated (or dehydrated). The adherent patch devices and processor system can be configured to detect sleep-cycle disruption and trigger an alert, which can result intervention so as to reduce daytime confusion and subsequent overmedication.
[0169] The adherent devices and processor system can be configured to monitor one or more of the following, so as to minimize, even prevent, events that may lead to irreversible damage. The adherent patch device coupled to the processor system can be configured to monitor one or more of the following: monitor activity patterns over time (signaling changes in physical or cognitive condition), monitor signs of agitation or over sedation, monitor for fall and "swoon" detection, monitor for unusual immobility, monitor changes in sleep patterns and sleep quality, monitor changes in breathing patterns, monitor hydration status, and/or monitor temperature.
[0170] II.1. Activity and movement monitoring
[0171] The adherent devices and processor system can be configured to track the customer's physical activity level over time (e.g., as a general health check). The adherent devices and processor system can be configured to determine a sudden or gradual reduction in physical activity and transmit a notification signal indicating the determined presence of a physical or cognitive problem.
[0172] The processor system and adherent device can monitor the condition of many neurological conditions, such as Parkinson's disease. For example, the processor system and adherent devices can be configured to track one or more of rigidity, gait disturbances, or tremor. [0173] II.2. Fall and "swoon" detection, and related alerts
[0174] The processor system and adherent devices can be configured to detect falls and determine that that is not caused by one or more arrhythmias. The adherent devices and processor system can be configured to determine the presence of an arrhythmia base on an ECG signal and alert medical staff. The adherent devices and processor system can be configured to distinguish between benign and malignant falls. A benign fall may comprise a fall which is followed immediately by the patient getting back up and resuming ambulation. The processor system coupled to the accelerometers of the adherent patch device can be configured to determine the orientation and ambulation of the patient subsequent to the fall. The processor system can be configured to tabulate and report the benign fall, and may generate a phone call to the patient to check his or her status. The processor system may not be configured to trigger emergency measures in response to the benign fall. A malignant fall may comprise a fall in which the patient falls and remains "down" for an extended period of time, for example, 1 or more minutes. The processor system can be configured to determine the presence of the malignant fall and trigger an emergency response. The adherent device may comprise a voice communication system, which can be configured to coupled the fallen person to another person to query the patient after the fall and determine whether the fall is benign or malignant based on the response of the fallen.
[0175] The adherent devices and processor system can be configured to determine the presence of sudden immobility that is not preceded by a fall. The adherent devices and processor system can be configured to determine the presence of a stroke or a heart attack, in which the patients may gently let him or her self down to the ground. Swoon may comprise patient lowered to the ground followed by immobility, for example without falling. Swoon may comprise prolonged immobility, such that an alert could be generated for any daytime immobility lasting an extended period of time, for example, 1 or more hours.
[0176] The processor system and adherent device can be configured to determine the presence of swoon in which an elder person is lying prone in a room where it would not be normal to do so (e.g., a kitchen, a bathroom, a basement, a garage, or a back yard). The systems and adherent devices described herein may comprise an in-house triangulation system configured to determine the customer's location within a dwelling. The processor system can be configured to generate a swoon alert based on orientation and a location of in the elder in the house, for example a supine elder in the middle of the kitchen.
[0177] In response to a determined fall or swoon, the processor system can transmit an alter to another customer in proximity, medical staff, or the like. Such contact may be through a simple phone call (in which case, customers may be encouraged to carry cell phones at all times), and/or by triggering an alert notice in the adherent device itself (e.g., a beep, a buzz, or a voice). When the alert goes off, the user may be expected to respond by saying a "passphrase" that would be recorded and transmitted by the microphone in the device. The lack of a response can suggest the patient has an altered state of consciousness, and would escalate the alert to a higher level.
[0178] The adherent devices may also have a customer-triggered alert in case the patient finds themselves in trouble and needing to summon help.
[0179] II.3. Ad hoc diagnostic capabilities
[0180] Periodically, either on a routine basis or in response to some new symptom or situation, the processor system and adherent devices can be configured to perform specific evaluations of sleep quality, status of COPD or asthma, screen for dyspnea on exertion or orthopnea, or do a "weak and dizzy" evaluation.
[0181] The processor system can be configured to determine factors linked to symptoms in elderly patients, such as cardiopulmonary, sleep, arrhythmia, movement disorder. The processor system and adherent device can be configured to periodically check the elder person and may be configured to screen the elder initially, for example to establish a baseline.
[0182] II.4 Additional Embodiments
[0183] In at least some embodiments, "chronic" monitoring for an elderly patient living alone may be done by with actigraphy, in which additional sensors may be added to the patient's device as needed in order to do specific diagnostics. In some embodiments, a "family" of custom devices, customized based on the specific monitoring needs of a patient, may be provided. Other form factors for actigraphy alone may also be considered.
[0184] Social networking.
[0185] The processor system can be configured to transmit alerts to the elderly person's local social network, such that alerts could be tiered to summon paramedics (e.g., for emergencies), the elderly person's designated family member (e.g., for questions of long-term changes), or a locally available member of a social network (e.g., such as in a retirement community) if a potential problem is identified that ought ideally to be evaluated locally before summoning either paramedics or loved ones.
[0186] The adherent devices and processor system can be configured to determine the presence of and classify many abnormal movements in patients who are elderly, or who have chronic neurological problems such as Parkinson disease or Alzheimer's (which may be characterized, for example, by symptoms of wandering, rigidity, tremors, postural instability, and various stereotypical movements), or who have sleep movement disorders, or who are at increased risk for stroke (in which case, it may be useful to detect hemiplegia or postural instability). In some embodiments, the adherent device and processor system may comprise circuitry executing computer programs for processing the activity signals that effectively differentiate between some of these movement disorders, or distinguishing between a smooth, steady gait and an abnormal gait. For example, such computer programs may use fractal analysis of accelerometer signals to detect various patterns of movement. Various kinds of movements may yield characteristic changes in the fractal dimensions of accelerometer signals. For example, fractal analysis used in seismology may be applied. Fractal analysis of seismographic signals can be used to characterize various types of geological faults, and to identify the fractal signals of distant underground nuclear explosions. The fractal analysis may be based on one or more of a binary fractal fracture network model, a variance of fractal dimensions, fractal dimension analysis, or fractal analysis with application to the accelerometer signals.
[0187] Figure 4A shows measurement signals, according to embodiments of the present invention. Such signals comprise patient data that can be measured with at least one accelerometer adhered to the patient as described herein. The measurement signals can be digitized with a processor supported with the adhesive of the respective adherent patch device, and the data can be time stamped such that the data can be combined, for example with at least one the gateway or the server.
[0188] The device adhered to the thorax can measure accelerometers signals, an electrocardiogram, respiration and temperatures. The accelerometer adhered to the thorax generates 3 accelerometer signals with each signal corresponding to one axis of the accelerometer. Signal TX corresponds to the X axis of the thorax accelerometer. Signal TY corresponds to the Y axis of the thorax accelerometer. Signal TZ corresponds to the Z axis of the thorax accelerometer. Signal ECG corresponds to the electrocardiogram signal of the patient measured from the thorax adherent device and comprises heart rate patient data. Signal Resp. corresponds to the respiration of the patient measured from the thorax adherent device, which can be measured in many ways, for example with impedance, as described above. Signal Temp, corresponds to the body temperature of the patient and can be measured with a temperature sensor and heat flux sensor coupled to the patient with the adherent patch device.
[0189] The accelerometer signals may correspond to different patient movement events. For example, as shown in Figure 4A, certain features of signals TX', TY' and TZ' may represent tremors and other certain features of signals TX', TY' and TZ' may represent patient attempts to arise from a prone position, such as attempts to get out of bed.
[0190] At least one of the processor comprising the tangible medium, a gateway processor comprising a gateway tangible medium or the server processor can be configured to detect the patient movement events in many ways. For example, at least one of the processor comprising the tangible medium, the gateway processor comprising the gateway tangible medium or the server processor can be configured to detect a tremor. At least one of the processor comprising the tangible medium, the gateway processor comprising the gateway tangible medium or the server processor can be configured to detect the tremor based on a sudden brief shock of muscle contractions. At least one of the processor comprising the tangible medium, the gateway processor comprising the gateway tangible medium or the server processor is configured to detect the tremor based on substantially sustained contractions of, for example, at least about 5 seconds. In some embodiments, the at least one of the processor comprising the tangible medium, the gateway processor comprising the gateway tangible medium or the server processor is configured to detect the patient's attempts to arise based on repeated myoclonic contractions that recur at intervals within a range, for example from about 0.2 Hz to about 5 Hz. Such signals can be identified in many ways, for example with at least one of a Fourier transform, cross- correlation, or a look up table.
[0191] Figure 4Al shows accelerometer signals for orientations of an accelerometer of adherent device on the thorax of the patient. The signals comprise signals X axis accelerometer signal TX, Y axis accelerometer signal TY, and Z axis accelerometer signal TZ. The signals can be low pass filtered to determine the orientation and high pass filtered to detect tremor or patient attempts to arise. The low pass filter can pass frequencies below about 2 Hz, for example below one Hz, and the high pass filter can pass frequencies above about 1 Hz, for example above about 2 Hz. Signal TZ shows an intensity of about Ig at time 0, corresponding to the Z-axis 112Z aligned with vertical, and X-axis 112X and Y-axis 112Y align with horizontal. For example, the patient may be sitting upright such that the Z axis of the accelerometer is aligned with vertical. Rotation of the accelerometer, for example about X-axis 112X results in a change in the Y-axis 112 Y and Z-axis 112Z signals, for example as shown at a time of about 4 seconds. Such rotation can occur when the standing patient moves to face different lateral sides. For times greater than about 6 seconds, the accelerometer is inverted, and Z-axis 112Z points downward.
[0192] Figure 4A2 shows orientation of the thorax of the patient that can be determined in response to signals as in Fig. 4Al. The signals from all 3-axes can be used to determine the orientation of the accelerometer. For example, LAZO corresponds to the orientation of the Z- axis. LAXO corresponds to the orientation of the X-axis, and LAYO corresponds to the orientation of the Y-axis.
[0193] The signals for the accelerometer can be used to determine the orientation of the thorax to which the accelerometer is coupled. Differential orientation signals can be measured to determine the orientation of the patient and determine whether the patient has a condition such as tremor or is attempting to arise from a prone position, for example. Such determination based on differential motion of accelerometers can minimize false positives, for example from natural patient motion such as walking.
[0194] Tremors, for example, Parkinson's tremors, can be determined in many ways with the accelerometer. At least one of the processor comprising the tangible medium, the gateway processor comprising the gateway tangible medium or the server processor can be configured to detect the tremor in many ways. At least one of the processor comprising the tangible medium, the gateway processor comprising the gateway tangible medium or the server processor can be configured to identify at least one of a rest tremor, a postural tremor or a kinetic tremor from based on a frequency of the movement and variability of the frequency of the movement. The at least one of the processor comprising the tangible medium, the gateway processor comprising the gateway tangible medium or the server processor can be configured to identify the tremor based on a rest tremor having a frequency within a range from about 3 Hz to about 8 Hz with fine, low amplitude movement. Such a determination can be made with a Fourier transform of the accelerometer data, and the transform calculated with the gateway or the server. The at least one of the processor comprising the tangible medium, the gateway processor comprising the gateway tangible medium or the server processor may be configured to detect the tremor based on a postural tremor having a frequency within a range from about 4 Hz to about 12 Hz with fine, low amplitude movement. The at least one of the processor comprising the tangible medium, the gateway processor comprising the gateway tangible medium or the server processor is configured to detect the tremor based on a kinetic tremor having a frequency within a range from about 2 to about 5 Hz with coarse, higher amplitude movement. Such determinations of the kind of tremor can be made based on the Fourier transform of the accelerometer data from each adherent device.
[0195] Referring again to Figure 5 and method 500 of monitoring an elder patient, a step 505 adheres a first adherent patch device to the patient, for example as described above. The first adherent patch device may comprise electronics modules fixed to the adherent patch device, for example disposable electronics with a disposable patch.
[0196] A step 510A measures first accelerometer signals along a first axis, for example an X- axis of a 3D accelerometer responsive to gravity as described above. A step 510B measures a first accelerometer signal along a second axis, for example a Y-axis of a 3D accelerometer as described above. A step 510C measures first accelerometer signals along a third axis, for example a Z-axis of 3D accelerometers as described above. Measurements of the accelerometer signals with step 510A, step 510B and step 51C, which may comprise sub-steps, can be performed with the patient in a known and/or determined position. The patient may be asked to stand and/or sit upright in a chair and the first signals measured to determine alignment of the accelerometers on the patient. In some embodiments, the 3D accelerometer signals can be analyzed to determine that the patient is standing, walking and the first signals determined from a plurality of measurements to indicate that the patient is upright for the measurement of the first signals.
[0197] A step 515 determines orientation of the first patch device on the patient. The accelerometer can be coupled to the patches with a pre-determined orientation, for example with connectors as described above, such that the 3D orientation of the patch can be determined from: the accelerometer signal, the orientation of the 3D accelerometer on the adherent patch, and the orientation of the patient. [0198] A step 520 measures a first ECG signal. The first ECG signal can be measured with the electrodes attached to the patient when the patch comprises the first orientation. The ECG signal can be measured with electronics components and electrodes, as described above.
[0199] A step 525 determines a first orientation of an electrode measurement axis on the patient, for example on the thorax of the patient. The electrode measurement axis may correspond to one of the measurement axes of the 3D accelerometer, for example an X-axis of the accelerometer as described above. However, the orientation of the electrode measurement axis can be aligned in relation to the axes of the accelerometer in many ways, for example at oblique angles, such that the alignment of the accelerometer with the electrode measurement axis is known and the signal from the accelerometer can be used to determine the alignment of the electrode measurement axis.
[0200] A step 530 determines a first orientation of the ECG vector. The orientation of the ECG vector can be determined in response to the polarity of the measurement electrodes and orientation of the electrode measurement axis, as described above.
[0201] A step 535 rotates a first ECG vector. The first ECG vector orientation of the ECG vector can be used to rotate the ECG vector onto a desired axis, for example an X-axis of the patient in response to the first orientation of the ECG vector and the accelerometer signal. For example, if the first measurement axis of the first ECG vector is rotated five degrees based on the accelerometer signal, the first ECG vector can be rotated by five degrees so as to align the first ECG vector with the patient axis.
[0202] A step 536 measures accelerometer signals with the adherent device positioned on the patient. The adherent device can measure and store that data with a processor on the adherent device.
[0203] A step 537 detects motion above a threshold. For example, the adherent devices can sample periodically sample the accelerometer for motion along at least one axis above a threshold.
[0204] A step 538 activates additional sensors in response to motion above the threshold. For example, one of the axes on the accelerometer can detect acceleration above a threshold. In response to motion above the threshold, the adherent device can transmit a signal, for example a wirelessly transmitted interrupt, to at least one other adherent device to trigger additional data acquisition and storage. The at least one other adherent device may comprise a first low power quiescent configuration that can be changed to a second high power active configuration to acquire additional data. For example, the adherent device on the thorax can acquire ECG and respiration data in response to the wireless interrupt from the sensor on the limb.
[0205] A step 539 measures additional signals, for example at least one of heart rate or respiration from the thorax. The additional signals may comprise accelero meter signals from the additional sensors on the other limbs of the patient.
[0206] A step 540 measures a first patient temperature. The first temperature of the patient can be measured with electronics of the adherent device, as described above.
[0207] A step 545 measures a first patient impedance. The first patient impedance may comprise a four pole impedance measurement, as described above. The first patient impedance can be used to determine respiration of the patient and/or hydration of the patient.
[0208] A step 545A determines a first hydration based on the impedance. [0209] A step 545B determines a first respiration based on the impedance.
[0210] A step 546 stores patient data in a circular buffer on each device. For example, the processor each the adherent device can store data to a RAM memory of the processor.
[0211] A step 547 time stamps the data stored on the adherent device. For example, the processor on an adherent device can time stamp the data stored in RAM. The gateway may transmit a time signal that is received by the adherent device such that the time stamps on each adherent device can be synchronized.
[0212] A step 548 pairs the adherent device with the gateway. The pairing can be sequential or simultaneous.
[0213] A step 549 transmits data from the adherent device to the gateway.
[0214] A step 550 receives, stores and combines data with the gateway. For example, the gateway can receive data sequentially from an adherent device and combine the data based on time stamp information for transmission to the server. [0215] A step 551 transmits combined data from the gateway to the remote server. The gateway may transmit frames of combined data. Alternatively or in combination, the remote server may combine the data based on time stamp information.
[0216] A step 552A high pass filters the accelerometer signals. The high pass filter may comprise an analog filter, a digital filter. The high pass filter data can be used to determine at least one of tremor or seizure of the patient. The high pass filter data can be generated with a Fourier transform, and/or other known transforms and filters. The high pass filter data, for example above about 1 Hz, as described above, can be used to determine at least one of tremor or seizure of the patient.
[0217] A step 552B low pass filters the accelerometer data, for example with a cutoff frequency of about 1 Hz. The low pass filter data can be used to determine the orientation of each limb.
[0218] A step 553 determines the orientation of the torso of the patient in response to the low pass filtered accelerometer data.
[0219] A step 554 determines a tremor in response to the orientation of the limbs and the high pass filter data. For example, the orientation of each limb and the high pass filter data can be combined to determine the tremor the patient. These data can be combined in many ways, for example with look up tables and indices based on studies on an empirical number of patients, for example about 100 patients for each of seizure detection and tremor detection.
[0220] In some embodiments, a step 555 adheres second patch devices to the patient, for example one week after the first patches to replace the first patch devices. The second patch devices may comprise second patch devices connected to reusable electronics modules, for example reusable electronics modules connected to the first patch devices for the first patient measurements above. The second patch devices may comprise second patches of second adherent devices comprising second electronics modules in which the second patch devices and second electronics modules comprise disposable second adherent devices and the first adherent patch devices and first electronics modules comprise first disposable adherent devices.
[0221] A step 555A measures second accelerometer signals along a first axis, for example a x- axis of the accelerometer as described above. The first axis may comprise the first axis of the first accelerometer as described above, for example the X-axis of the accelerometers used to measure the X-axis signals with the first measurements. In some embodiments, the second accelerometer signals along the first axes may comprise X-axes of second accelerometers, for example second disposable electronics modules, aligned with electrode measurement axes as described above.
[0222] A step 555B measures a second accelerometer signal along a second axis of the second accelerometers for example a Y-axis.
[0223] A step 555C measures a second accelerometer signal along third axis, for example Z- axes.
[0224] A step 560 determines orientations of the second patch on the patient. The accelerometers can be coupled to the second patch with a pre-determined orientation, for example with connectors as described above, such that the orientations of the second patch can be determined from: the second accelerometer signals, the pre-determined orientations of the 3D accelerometers on the adherent patches, and the orientation of the patient.
[0225] A step 565 measures a second ECG signal. The second ECG signal can be measured with the electrodes attached to the patient when the second patch comprises the second orientation, for example after the first patch has been removed and the second patch has been positioned on the patient as described above. The ECG signal can be measured with electronics components and electrodes, as described above.
[0226] A step 570 determines a second orientation of the electrode measurement axis on the patient. The second orientation of the electrode measurement axis may comprise orientation of an axis of a second set of electrodes, for example a second set of electrodes disposed along an axis of the second patch. The second orientation of the electrode measurement axis may correspond to one of the measurement axes of the 3D accelerometer, for example an X-axis of the accelerometer as described above. However, the second orientation of the electrode measurement axis can be aligned in relation to the axes of the accelerometer in many ways, for example at oblique angles, such that the alignment of the accelerometer with the second electrode measurement axis is known and the signal from the accelerometer can be used to determine the alignment of the electrode measurement axis.
[0227] A step 575 determines a second orientation of the ECG vector. The second orientation of the ECG vector can be determined in response to the polarity of the second measurement electrodes and second orientation of the electrode measurement axis, for example second measurement electrodes on the second adherent patch that extend along the electrode measurement axis of the second adherent patch.
[0228] A step 580 rotates a second ECG vector. The second ECG vector orientation of the second ECG vector can be used to rotate the second ECG vector onto the desired axis, for example the X-axis of the patient in response to the first orientation of the ECG vector and the accelerometer signal. For example, if the first measurement axis of the first ECG vector is rotated five degrees from the X-axis based on the accelerometer signal, the first ECG vector can be rotated by five degrees so as to align the first ECG vector with the X-axis of the patient, for example the horizontal axis of the patient.
[0229] A step 585 measures a second patient temperature. The second temperature of the patient can be measured with electronics of the adherent device, as described above.
[0230] A step 590 measures a second patient impedance. The second patient impedance may comprise a four pole impedance measurement, as described above. The second patient impedance can be used to determine respiration of the patient and/or hydration of the patient.
[0231] A step 590A determines a second hydration based on the second impedance. [0232] A step 590B determines a second respiration based on the second impedance.
[0233] A step 595combines the data of the person to determine the status of the person. The signals, including those of movement, orientation, heart rate, respiration rate, and hydration level as described herein, can be combined in many ways. In some embodiments, the signals can be used simultaneously to determine the impending elder physiological or mental deterioration. For example, a decreased measurement of the hydration of the elder patient can be combined with a decreased accelerometer measurement to indicate that the elder patient may have fallen and cannot get up to access to fluid. For example, a decreased accelerometer measurement can be combined with a decreased measurement of the hydration of the elder patient to indicate an increased risk of the occurrence of decubitus ulcers. For example, an increasing heart rate and/or respiration rate may coincide with a decrease in patient hydration.
[0234] In some embodiments, the signals can be combined by using the at least two of the electrocardiogram signal, the respiration signal or the activity signal to look up a value in a previously existing array. [0235] Table 1. Lookup Table for Activity and Hydration Signals.
Figure imgf000057_0001
[0236] Table 1 shows combination of the electrocardiogram signal with the respiration signal to look up a value in a pre-existing array. For example, at an activity in the range from A to B, for example threshold crossings per unit time and a hydration in the range from U to V, for example Ohms triggers a response of N. In some embodiments, the values in the table may comprise a tier or level of the response, for example four tiers. In specific embodiments, the values of the look up table can be determined in response to empirical data measured for an elder person population of at least about 10 elder persons, for example measurements on about 100 to 1,000 elder persons. The look up table shown in Table 1 illustrates the use of a look up table in accordance with one embodiment, and one will recognize that many variables can be combined with a look up table. The look up table may be used to combine two or more of activity data, hydration data, orientation data, heart rate data or respiration data
[0237] In some embodiments, the table may comprise a three or more dimensional look up table, and the look up table may comprises a tier, or level, of the response, for example an alarm.
[0238] In some embodiments, the signals may be combined with at least one of adding, subtracting, multiplying, scaling or dividing the at least two of the activity signal, the hydration signal, the respiration signal or the orientation signal. In specific embodiments, the measurement signals can be combined with positive and or negative coefficients determined in response to empirical data measured for an elder person population of at least about 10 elder persons, for example data on about 100 to 1000 elder persons.
[0239] In some embodiments, a weighted combination may combine at least two measurement signals to generate an output value in accordance with a formula of the general form
OUTPUT = aX + bY where a and b comprise positive or negative coefficients determined from empirical data and X, and Z comprise measured signals for the elder person, for example two or more of activity data, hydration data, orientation data, heart rate data or respiration data. While two coefficients and two variables are shown, the data may be combined with multiplication and/or division. One or more of the variables may be the inverse of a measured variable. The combination may comprise two or more of activity data, hydration data, orientation data, heart rate data or respiration data
[0240] In some embodiments, the ECG signal comprises a heart rate signal that can be divided by the activity signal. Work in relation to embodiments of the present invention suggest that an increase in heart rate with a decrease in activity can indicate an impending physiological or mental deterioration. The signals can be combined to generate an output value with an equation of the general form
OUTPUT = aX /Y + bZ where X comprise a heart rate signal, Y comprises an activity signal and Z comprises a respiration signal, with each of the coefficients determined in response to empirical data as described above.
[0241] In some embodiments, the data may be combined with a tiered combination. The combination may comprise two or more of activity data, hydration data, orientation data, heart rate data or respiration data. While many tiered combinations can be used a tiered combination with three measurement signals can be expressed as
OUTPUT = (ΔX) + (ΔY) + (ΔZ) where (ΔX), (ΔY), (ΔZ) may comprise change in heart rate signal from baseline, change in respiration signal from baseline and change in activity signal from baseline, and each may have a value of zero or one, based on the values of the signals. For example if the heart rate increase by 10%, (ΔX) can be assigned a value of 1. If respiration increases by 5%, (ΔY) can be assigned a value of 1. If activity decreases below 10% of a baseline value (ΔZ) can be assigned a value of 1. When the output signal is three, a flag may be set to trigger an alarm.
[0242] In some embodiments, the data may be combined with a logic gated combination. The combination may comprise two or more of activity data, hydration data, orientation data, heart rate data or respiration data. While many logic gated combinations can be used, a logic gated combination with three measurement signals can be expressed as OUTPUT = (ΔX) AND (ΔY) AND (ΔZ) where (ΔX), (ΔY), (ΔZ) may comprise change in heart rate signal from baseline, change in respiration signal from baseline and change in activity signal from baseline, and each may have a value of zero or one, based on the values of the signals. For example if the heart rate increase by 10%, (ΔX) can be assigned a value of 1. If respiration increases by 5%, (ΔY) can be assigned a value of 1. If activity decreases below 10% of a baseline value (ΔZ) can be assigned a value of 1. When each of (ΔX), (ΔY), (ΔZ) is one, the output signal is one, and a flag may be set to trigger an alarm. If any one of (ΔX), (Δ Y) or (ΔZ) is zero, the output signal is zero and a flag may be set so as not to trigger an alarm. While a specific example with AND gates has been shown the data can be combined in may ways with known gates for example NAND, NOR, OR, NOT, XOR, XNOR gates. In some embodiments, the gated logic may be embodied in a truth table.
[0243] The data of the elder person can be combined in many ways, for example with the processor system to determine a status of the elder person, for example to determine a condition of the elder person used to trigger an alter. The processor system can be configured to determine at least one of an over sedation- or an agitation of the elder person. The processor system may be configured to combine two or more of activity data, hydration data, orientation data, heart rate data or respiration data to determine the over sedation or the agitation of the elder person.
[0244] The method of the processor system can be configured to determine a fall of the patient. The processor system may be configured to combine two or more of activity data, hydration data, orientation data, hear rate data or respiration data to determine the fall of the elder person.
[0245] The method of the processor system can be configured to determine an attempt of the elder person to get out of a bed. The user comprises a bed ridden patient and the processor system is configured to determine the attempt based on one or more of a tremor of the activity data, an orientation change toward upright of the orientation data, an increase in heart rate of the heart rate data or an increase in respiration of respiration of the respiration data. The processor system may be configured to combine two or more of the activity data, the hydration data, the orientation data, the heart rate data or the respiration data to determine the attempt of the elder person. [0246] The method of the processor system can be configured to determine a risk of the elder person to a decubitus ulcer and issue at least one of a notification. The processor system may be configured to determine the risk based on the activity data and the orientation data. The processor system may be configured to determine the risk based on an amount of time a surface of the elder person is oriented toward a bed. The elder person may comprise at least one of a bed ridden patient or an ambulatory patient. The processor system can be configured to receive as input one or more locations of one or more decubitus ulcers and issue a notification based on the patient orientation data and the locations of the one or more decubitus ulcers.
[0247] The method of the processor system can be configured to combine the measured activity data in many ways. The processor system can be configured to receive as input a target activity amount of the elder person. The processor system is configured to issue at least one of a notification, an alert or an alarm in response to patient activity data corresponding to patient activity below the target activity amount. The processor system can be configured to store first elder person activity comprising an activity baseline and compare the activity baseline with the activity data to determine a change in activity from baseline. The processor system is configured to issue an alert when the change in activity from baseline exceeds an amount. The processor system is configured to store an activity profile of the patient corresponding to at least one week of activity data. The processor system can be configured to display the activity profile to a user. [0248] The method of the processor system can be configured to determine REM sleep of the user based on the activity data. In some embodiments, the processor system may be configured to determine the REM sleep of the user based on one or more frequencies of movement of the activity data, wherein the one or more frequencies of movement correspond to a time when the patient is asleep.
[0249] The method of the processor system can be configured to combine two or more of activity data, hydration data, orientation data, heart rate data or respiration data to determine a sleep status of the patient. The sleep status may comprise a sleep quality.
[0250] The method of the processor system can be configured to combine two or more of activity data, hydration data, orientation data, heart rate data or respiration data to determine a swoon of the patient. The processor system may be configured to determine the swoon based on prolonged immobility. The processor system may be configured to determine the swoon based an orientation the patient and a location of the patient within the home. The system may further comprise a triangulation system to determine the location of the patient within the home.
[0251] A step 596 determines a tiered response, for example, from measurement data taken by an adherent device placed on the elder person. A step 596A comprises a first tier response which alerts an emergency responder. A step 596B comprises a second tier response which alerts a physician. A step 596C comprises a third tier response which alerts an elder person, family, or caregiver. A step 596D comprises a fourth tier response which alerts a remote center. A tiered response may also comprise of wirelessly transmitting the at least two of the electro cardiogram signal, the respiration signal, or the activity signal with a single wireless hop from a wireless communication circuitry to an intermediate device.
[0252] A step 597 communicates with the person's social network. The communication may comprise wireless communication with the gateway, for example peer to peer communication of similar devices of similarly situated elder persons. The social network communication may also comprise uploading the data to a server system.
[0253] A step 598 communicates with a far end speaker, for example with cellular communication of the gateway device paired to adherent device, such that the elder person can speak with a far end user.
[0254] A step 599 repeats the above steps. The above steps can be repeated to provide longitudinal monitoring of the patient with differential measurement of patient status. The monitoring of the patient may comprise a comparison of baseline patient data with subsequent patient date.
[0255] The processor system, as described above, may perform the method 500, including many of the steps described above. It should be appreciated that the specific steps illustrated in Figure 5 provide a particular method of monitoring an elder person and responding to a signal event, in accordance with an embodiment of the present invention. Other sequences of steps may also be performed in accordance with 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 Figure 5 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.
[0256] EXPERIMENTAL CLINICAL STUDY
[0257] An experimental clinical study can be conducted to on an empirical number of elder people to determine empirically parameters of the above described adherent device and processor system. The empirically determined parameters can be used with programs of the processor system to determine status of the elder person, for example to determine a deterioration in the status, based on the teachings as described herein. The parameters of the adherent device and support may be determined such that the adherent device can be continuously adhered to the elderly skin of an elder person for an extended period of at least one week and removed without substantial skin irritation. The parameters of the adherent patch device and support that can be determined for use with an elder person may comprise one or more of adhesion strength, peel strength, skin contact adhesion, breathability, percent elongation or strain. For example, an increase in ability of the cover and support to stretch with the skin of the patient can increase the amount of time the device can be adhered to the elderly skin, such that the adhesion strength an peel strength may be decreased, as compared with device configured to adhere to the skin of younger people. The protocol for testing can be adapted for testing elder patients and similar to the protocol described in U.S. Pat. App. No. 12/209,288, entitled "Adherent Device with Multiple Physiological Sensors", filed on September 12, 2008. The protocol can be used to measure signals from actual patients with an adherent device. These data can show that an adherent patch as described above can be continuously adhered to an elder person for at least one week. These data may also show that 90 day continuous in home monitoring of elder people can be achieved with a set of 13 patches in which one of the patches is replaced each week. Additional empirical studies can be conducted on a suitable number of elder people to minimize adverse events and extend the duration of continuous adhesion beyond one week, based on the teachings described herein.
[0258] 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. A device to monitor an elder person having a skin, the device comprising: a support comprising an adhesive configured to adhere to the skin, the support configured to stretch with the skin when adhered to the skin; two or more sensors configured to measure data from the elder person, the two or more sensors coupled to the support to support the sensors with the skin when the support is adhered to the skin; and circuitry coupled to the two or more sensors and configured to transmit the data from the elder person, the circuitry coupled to the support to support the circuitry with the skin' when the support is adhered to the skin.
2. The device of claim 1 wherein the two or more sensors are configured to measure two or more of hydration data, activity data, respiration data, heart rate data, orientation data, temperature data, blood oxygen data or sound data.
3. The device of claim 2 wherein the two or more sensors are configured to measure the hydration data with impedance circuitry, the activity data with an accelerometer, the respiration data with impedance circuitry, the heart rate data with ECG circuitry, the orientation data with the accelerometer, the temperature data with temperature circuitry, blood oxygen data with pulsed oximeter circuitry or the sound data with microphone circuitry.
4. The device of claim 2 wherein the two or more sensors are configured to measure the hydration data and the activity data and wherein the circuitry is configured to combine the hydration data and the activity data and transmit a notification based on the hydration data and the activity data.
5. The device of claim 4 wherein the circuitry is configured to determine a mental status of the elder person in response to the hydration data combined with the activity data and wherein the notification corresponds to the mental status of the elder person.
6. The device of claim 1 wherein the sound data comprises internal sounds from within the elder person and external sounds from outside the elder person.
7. The device of claim 6 wherein the circuitry is configured to measure and transmit the elder person's voice in response to a command from the elder person.
8. The device of claim 7 wherein the adherent device further comprises a speaker coupled to the adherent support and wherein the circuitry comprises two way wireless communication circuitry such that the elder person can speak with far end speaker.
9. The device of claim 8 wherein the circuitry is configured to pair with at least one of a cell phone or a gateway and establish a connection with the far end speaker in response to the user command.
10. The device of claim 8 wherein the circuitry is configured to pair with the at least one of the cell phone or the gateway and establish the connection with the far end speaker in response to one or more of a fall, a cardiac arrhythmia, a dehydration, an edema, a syncope, a respiratory distress, a bed sore risk, a prolonged inactivity, a stress, a respiratory distress, or a fever.
11. The device of claim 1 wherein adherent device is configured to adhere to communicate to a similar adherent device with peer to peer communication.
12. A method of monitoring an elder person having a skin, the method comprising: adhering a support comprising an adhesive to the skin, wherein the support stretches with the skin when adhered to the elder skin; measuring data from the elder person with two or more sensors, wherein the two or more sensors are supported with the skin when the support is adhered to the skin; and transmit the data from the elder person with circuitry, wherein the circuitry is coupled to the support such that the circuitry is supported with the skin when the data are transmitted.
13. A system to care for an elder person having a skin, the system comprising: an adherent device comprising a support configured to adhere to the skin, the adherent device comprising two or more sensors configured to measure data when the support is adhered to the skin; and a gateway configured to communicate with the adherent device.
14. The system of claim 13 further comprising: a processor system comprising one or more of a processor of the adherent device, a processor of the gateway or a processor of a remote server, wherein the processor system is configured to determine a status of the elder person.
15. The system of claim 14 wherein the processor system comprises a tangible medium having instructions of a computer program embodied thereon such that the processor system is configured to determine the status of the patient.
16. The system of claim 14 wherein the processor system is configured to determine at least one of an over sedation or an agitation of the elder person.
17. The system of claim 16. wherein the processor system is configured to combine two or more of activity data, hydration data, orientation data, heart rate data or respiration data to determine the over sedation or the agitation of the elder person.
18. The system of claim 14 wherein the processor system is configured to determine a fall of the patient.
19. The system of claim lδwherein the processor system is configured to combine two or more of activity data, hydration data, orientation data, heart rate data or respiration data to determine the fall of the elder person.
20. The system of claim 14 wherein the processor system is configured to determine an attempt of the elder person to get out of a bed, wherein the user comprises a bed ridden patient and the processor system is configured to determine the attempt based on one or more of a tremor of the activity data, an orientation change toward upright of the orientation data, an increase in heart rate of the heart rate data or an increase in respiration of respiration of the respiration data.
21. The system of claim 20 wherein the processor system is configured to combine two or more of the activity data, the hydration data, the orientation data, the heart rate data or the respiration data to determine the attempt of the elder person to get out of bed.
22. The system of claim 14 wherein the processor system is configured to determine a risk of the elder person to a decubitus ulcer and issue at least one of a notification, an alert or an alarm in response to the risk.
23. The system of claim 22 wherein the processor system is configured to determine the risk based on the activity data and the orientation data.
24. The system of claim 23 wherein the processor system is configured to determine the risk based on an amount of time a surface of the elder person is oriented toward a bed.
25. The system of claim 23 wherein the elder person comprises at least one of a bed ridden patient or an ambulatory patient.
26. The system of claim 14 wherein the processor system is configured to receive as input one or more locations of one or more decubitus ulcers and issue a notification based on the patient orientation data and the locations of the one or more decubitus ulcers.
27. The system of claim 14 wherein the processor system is configured to receive as input a target activity amount of the elder person and wherein the processor system is configured to issue at least one of a notification, an alert or an alarm in response to patient activity data corresponding to patient activity below the target activity amount.
28. The system of claim 14 wherein the processor system is configured to store first elder person activity comprising an activity baseline and compare the activity baseline with the activity data to determine a change in activity from baseline and wherein the processor system is configured to issue an alert when the change in activity from baseline exceeds an amount.
29. The system of claim 14 wherein the processor system is configured to store an activity profile of the patient corresponding to at least one week of activity data and wherein the processor system is configured to display the activity profile to a user.
30. The system of claim 14 wherein the processor system is configured to determine a REM sleep of the user based on the activity data.
31. The system of claim 30 wherein the processor system is configured to determine the REM sleep of the user based on one or more frequencies of movement of the activity data and wherein the one or more frequencies of movement correspond to a time when the patient is asleep.
32. The system of claim 30 wherein the processor system is configured to combine two or more of activity data, hydration data, orientation data, heart rate data or respiration data to determine a sleep status of the patient.
33. The system of claim 32 wherein the sleep status comprises a sleep quality.
34. The system of claim 30 wherein the processor system is configured to combine two or more of activity data, hydration data, orientation data, heart rate data or respiration data to determine a swoon of the patient.
35. The system of claim 34 wherein the processor system is configured to determine the swoon based on prolonged immobility.
36. The system of claim 34 wherein the processor system is configured to determine the swoon based an orientation the patient and a location of the patient within the home and wherein the system further comprises a triangulation system to determine the location of the patient within the home.
37. The system of claim 13 further comprising a robotic aide configured to receive, store and respond to the elder person's vital signs.
38. The system of claim 13 wherein the gateway is configured to couple to a processor system comprising an online social network and wherein the gateway is configured to transmit the data to the social network such that where network members can view the status of the elder person.
39. The system of claim 38 wherein the gateway is configured communicate with substantially similar gateways with a peer to peer communication protocol to couple the elder person with another elder person wearing a substantially similar adherent device.
40. A device to monitor an elder person having an elder skin, the device comprising: a support comprising an adhesive configured to adhere to the elder skin, the support configured to stretch with the elder skin when adhered to the elder skin; two or more sensors configured to measure data from the elder person, the two or more sensors coupled to the support to support the sensors with the elder skin when the support is adhered to the elder skin; and circuitry coupled to the two or more sensors and configured to transmit the data from the elder person, the circuitry coupled to the support to support the circuitry with the elder skin when the support is adhered to the elder skin.
41. The device of claim 40 wherein the circuitry comprises a processor comprising a tangible medium coupled to the two or more sensors to measure and process the data and wherein the circuitry comprises wireless communication circuitry coupled to the processor and configured transmit the data.
42. The device of claim 40 further comprising a cover coupled to an outer portion of the support, the cover configured to stretch with the support when the elder skin stretches to minimize stress to the elder skin.
43. The device of claim 40 wherein the support is configured to adhere continuously to the elder skin for at least about one week without substantial irritation of the elder skin.
44. The device of claim 43 wherein the support is configured to adhere continuously to the elder skin with one or more of adhesion strength, peel strength, skin contact adhesion, breathability, percent elongation or strain,
45. A method of monitoring an elder person having an elder skin, the method comprising: adhering an adherent device to the elder skin; measuring data of the elder person when the device is adhered to the elder skin such that sensors of the adherent device are coupled to the elder skin; and transmitting the data with wireless communication circuitry supported with the elder skin.
46. The method of claim 40 wherein the patch adheres continuously to the elder skin for at least about one week without substantial irritation of the elder skin and wherein a cover of the patch and a support are configured with one or more of adhesion strength, peel strength, skin contact adhesion, breathability, percent elongation or strain, such that a support of the device and a cover of the device stretch with the elder skin,
47. The method of claim 45 wherein a deterioration of the elder person is determined based on the data transmitted.
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