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WO2025085288A1 - Systèmes et procédés d'évaluation de l'activité cardiaque d'un sujet - Google Patents

Systèmes et procédés d'évaluation de l'activité cardiaque d'un sujet Download PDF

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Publication number
WO2025085288A1
WO2025085288A1 PCT/US2024/050497 US2024050497W WO2025085288A1 WO 2025085288 A1 WO2025085288 A1 WO 2025085288A1 US 2024050497 W US2024050497 W US 2024050497W WO 2025085288 A1 WO2025085288 A1 WO 2025085288A1
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Prior art keywords
subject
electrodes
locations
heart
patch
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English (en)
Inventor
Landy Toth
Kevin D'AQUILLA
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Lifelens Technologies Inc
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Lifelens Technologies Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0033—Features or image-related aspects of imaging apparatus, e.g. for MRI, optical tomography or impedance tomography apparatus; Arrangements of imaging apparatus in a room
    • A61B5/004—Features or image-related aspects of imaging apparatus, e.g. for MRI, optical tomography or impedance tomography apparatus; Arrangements of imaging apparatus in a room adapted for image acquisition of a particular organ or body part
    • A61B5/0044—Features or image-related aspects of imaging apparatus, e.g. for MRI, optical tomography or impedance tomography apparatus; Arrangements of imaging apparatus in a room adapted for image acquisition of a particular organ or body part for the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/055—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/282—Holders for multiple electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6823—Trunk, e.g., chest, back, abdomen, hip
    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06N—COMPUTING ARRANGEMENTS BASED ON SPECIFIC COMPUTATIONAL MODELS
    • G06N3/00—Computing arrangements based on biological models
    • G06N3/02—Neural networks
    • G06N3/04—Architecture, e.g. interconnection topology
    • G06N3/0464—Convolutional networks [CNN, ConvNet]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/046—Arrangements of multiple sensors of the same type in a matrix array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0492—Patch electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators

Definitions

  • the present disclosure relates generally to the field of physiologic monitoring and, more particularly, to devices and systems for assessing heart activity.
  • An electrophysiology (EP) study is a test that is used to evaluate a subject’s heart activity and to check for abnormal heart rhythms. The test is performed by inserting catheters and then wiring electrodes, which measure electrical activity, through blood vessels that enter the heart thus maintaining the flow of blood. Movement of the heart leads to heartbeats or heart rhythms.
  • specialists in heart rhythms or an EP specialist may also map the spread of the heart’s electrical impulses during each beat to find the source of an abnormal heartbeat. Further, the EP study tests the electrical activity of the subject’s heart to find where an arrhythmia (e.g., an abnormal heartbeat) is originating.
  • an arrhythmia e.g., an abnormal heartbeat
  • Such testing helps the subject and their doctor to decide whether the subject needs medicine, a pacemaker, an implantable cardioverter defibrillator (ICD), cardiac ablation, a surgery, etc. It should be noted that such studies take place in a special room called an EP laboratory (EP lab) or catheterization laboratory (Cath lab) while the subject is mildly sedated.
  • EP lab an implantable cardioverter defibrillator
  • Cath lab catheterization laboratory
  • the positioning of the catheters inside the heart of the subject will be monitored on a screen. It should be noted that the subject may feel pressure and discomfort when the catheters are inserted.
  • a major drawback in this technology is that it becomes difficult to manage all the sensors in and on the body due to a plurality of cables.
  • EP study is not compatible with Magnetic Resonance Imaging (MRI) as the EP study may produce local currents that go through the body of the subject which are interpreted together into a display screen, thereby leading to generation of an inaccurate map of the heart.
  • MRI Magnetic Resonance Imaging
  • Another drawback is that the subject needs to be completely lying in a still position for long hours.
  • Another technology includes a system and a method for the guidance of a catheter with one or more electrodes in an EP procedure, in which a sequence of images of the catheter and of a resting reference catheter is generated with an X-ray device and stored together with associated electrographic recordings from the electrodes. Further, a reference image may be selected from the sequence that corresponds to a desired electrographic pattern. In a next step, the positions of the catheters are localized on the reference image. The position of the reference catheter can be identified with the position of the catheter on an actual image. Thus, it is possible to determine on the actual image also a target position for the catheter that corresponds to the position of this catheter on the reference image. The target position may finally be indicated on a monitor to assist the guidance of the catheter to a desired location.
  • the catheter involves a plurality of electrodes connected by a plurality of wires.
  • wires are not compatible with the MRI, as wires are made up of metal which gets heated up easily during MRI.
  • EP mapping involves placing electrodes on the subject lying in a bed or table, and introducing the catheter up through an artery into the heart of the subject to map data related to the heart of the subject.
  • mapped data includes, for example, a number of heartbeats, a rate at which the heart is beating in terms of seconds, etc.
  • drugs are injected and surgeries are performed to put the heart of the subject in a certain state so that a three-dimensional (3D) picture of the heart is obtained.
  • the EP mapping involves hundreds of individually placed electrodes interconnected to each other through wires.
  • the major drawback of this technology involving the principle of EP mapping is that the wires used are not compatible with the MRI, as the wires are made up of metal which gets heated up in the MRI, especially when the EP mapping and MRI are performed simultaneously. Moreover, the electrodes which are placed in the body of the subject are placed by hand, which consumes a lot of time to analyze and figure out locations of the electrodes relative to each other.
  • electro physiotherapy is measured using electrodes.
  • the electrodes are taken off and the subject is put in the MRI.
  • Different datasets corresponding to subject health parameters are detected, thereby carrying out EP measurement for the subject.
  • the challenge with this technology is that it becomes really hard to manage data related with the EP for the subject.
  • arrhythmia which is a condition of abnormal heartbeat occurring in subjects.
  • the procedure in this technology is very complex as it utilizes intra-heart EP catheters. [0008] Therefore, there is a need for an efficient, convenient, consistent, reliable capable EP and other physiologic monitoring systems, including MRI-capable EP systems for performing EP mapping and MRI simultaneously to assess a subject’s heart activity.
  • One illustrative, non-limiting objective of this disclosure is to provide systems, devices, and methods for physiologic monitoring of a subject. Another illustrative, nonlimiting objective is to provide functionality for assessing heart activity of a subject. Yet another illustrative, non-limiting objective is to provide functionality for performing electrophysiology (EP) mapping and Magnetic Resonance Imaging (MRI) simultaneously to assess heart activity of a subject.
  • EP electrophysiology
  • MRI Magnetic Resonance Imaging
  • a system comprises a multi-hub patch interface comprising a plurality of electrodes configured for monitoring electrophysiologic signals from a body of a subject, the plurality of electrodes being arranged in two or more electrode clusters at a first set of locations on the multi-hub patch interface.
  • the system also comprises two or more hubs configured for attachment to the multi-hub patch interface, each of the two or more hubs being associated with one of the two or more electrode clusters at one of the first set of locations on the multi-hub patch interface, each of the two or more hubs being configured for collecting data characterizing the monitored electrophysiologic signals from a subset of the plurality of electrodes belonging to its associated one of the two or more electrode clusters.
  • the system further comprises at least one processing device coupled to the two or more hubs.
  • the at least one processing device is configured to generate a mapping of body surface potential of the subject based at least in part on correlating the data collected from the two or more hubs, the data being correlated based at least in part on distances between different ones of the first set of locations on the multi-hub patch interface.
  • the at least one processing device is also configured to determine a transformed set of electrophysiologic signals for a second set of locations different than the first set of locations based at least in part on the generated mapping of the body surface potential of the subject.
  • Determining the transformed set of electrophysiologic signals for the second set of locations may utilize one or more machine learning models.
  • the one or more machine learning models may be configured to simulate three-dimensional signal propagation information based at least in part on a compositional model of at least a portion of the body of the subject.
  • the compositional model may comprise a torso compositional model selected based at least in part on signal correlation estimates for the data collected from the two or more hubs.
  • the multi-hub patch interface may be configured for attachment to a torso of the subject, and the data characterizing the monitored electrophysiologic signals may be utilized to determine heart activity of the subject based at least in part on correlating the monitored electrophysiologic signals with information relating to positioning of the first set of locations on the torso of the subject relative to a heart of the subject.
  • the data characterizing the monitored electrophysiologic signals may be utilized to determine heart activity of the subject.
  • the heart activity may be determined based at least in part on a model of the heart of the subject.
  • the model of the heart of the subject may be generated based at least in part on a series of one or more imaging studies, magnetic resonance imaging (MRI) studies and computerized tomography (CT) studies for a plurality of subjects.
  • the model of the heart of the subject may also or alternatively be generated based at least in part on at least one of one or more images of torsos of a plurality of subjects and one or more three-dimensional torso models.
  • the model of the heart of the subject may further or alternatively be generated based at least in part on at least one of postural information associated with the subject, respiration of the subject, heart orientation of the subject, heart size of the subject, and heart functional information of the subject.
  • the determined heart activity of the subject may comprise at least one of a number of heartbeats per second, a heartbeat rate, a maximum heartbeat rate in a given time period, and a target heartbeat rate range.
  • the at least one processing device may be further configured to determine a location of heart damage in a heart of the subject based at least in part on the correlations of the monitored electrophysiologic signals and information relating to the positioning of the plurality of electrodes relative to one another.
  • the at least one processing device may be further configured to find an ectopic source of an arrythmia in a heart of the subj ect based at least in part on the correlations of the monitored electrophysiologic signals and information relating to the positioning of the plurality of electrodes relative to one another.
  • the at least one processing device may be further configured to map a spread of electrical impulses in a heart of the subject in each of one or more heartbeats of the subject based at least in part on the correlations of the monitored electrophysiologic signals and information relating to the positioning of the plurality of electrodes relative to one another.
  • the at least one processing device may be further configured to provide, to the two or more hubs, signaling for controlling at least one of an amount and a frequency of voltage supplied to respective ones of the plurality of electrodes.
  • the at least one processing device may be further configured to determine information characterizing working of the plurality of electrodes.
  • the determined information characterizing the working of the plurality of electrodes may comprise at least one of an amount and a frequency of voltage that is at least one of sent to and received from respective ones of the plurality of electrodes.
  • the signaling for controlling said at least one of the amount and the frequency of the voltage supplied to respective ones of the plurality of electrodes may comprise setting a power status of respective ones of the plurality of electrodes to an on state or an off state.
  • the signaling for controlling said at least one of the amount and the frequency of the voltage supplied to respective ones of the plurality of electrodes comprises, for at least a given one of the plurality of electrodes, altering at least one of the amount and the frequency of the voltage supplied to the given electrode.
  • a given one of the two or more electrode clusters may comprise a given subset of the plurality of electrodes arranged in two or more rows and two or more columns, and the system may further comprise a cross-point switch having two or more input lines and two or more output lines and a plurality of switches, the two or more input lines and the two or more output lines forming a crossed pattern of interconnecting lines at each intersection of the two or more rows and the two or more columns, wherein one of the plurality of switches is located at each of the intersections of the two or more rows and the two or more columns.
  • the at least one processing device may be configured to utilize the cross-point switch to selectively open and close the plurality of switches to determine at least one of voltage and current levels of ones of the plurality of electrodes in the given subset of the plurality of electrodes.
  • the at least one processing device may also or alternatively be configured to utilize the cross-point switch to selectively open and close the plurality of switches to create a desired current flow through the body of the subject utilizing the given subset of the plurality of electrodes.
  • the at least one processing device may be further configured to determine an electrocardiogram lead equivalent provided by the plurality of electrodes of the multi-hub patch interface.
  • the second set of locations may comprise one or more lead locations for an electrocardiogram measurement of the subject.
  • the one or more lead locations for the electrocardiogram measurement of the subject may comprise 12-lead electrocardiogram sites.
  • an apparatus comprises at least one processing device comprising a processor coupled to a memory.
  • the at least one processing device is configured to collect electrophysiologic signals from a plurality of electrodes at a first set of locations on a body of a subject.
  • the at least one processing device is also configured to generate a mapping of body surface potential of the subject based at least in part on correlating the electrophysiologic signals with one another, the correlations being based at least in part on estimates of distances between different ones of the first set of locations.
  • the transformed electrophysiologic signals may characterize heart activity of the subject.
  • the at least one processing device may be further configured to determine a location of heart damage in a heart of the subject based at least in part on the transformed electrophysiologic signals.
  • the at least one processing device may also or alternatively be configured to find an ectopic source of an arrythmia in a heart of the subject based at least in part on the transformed electrophysiologic signals.
  • the at least one processing device may further or alternatively be configured to map a spread of electrical impulses in a heart of the subject in each of one or more heartbeats of the subject based at least in part on the transformed electrophysiologic signals.
  • the at least one processing device may be further configured to utilize the transformed electrophysiologic signals to determine at least one of a number of heartbeats per second, a heartbeat rate, a maximum heartbeat rate in a given time period, and a target heartbeat rate range.
  • the second set of locations may comprise one or more lead locations for an electrocardiogram measurement of the subject.
  • the one or more lead locations for the electrocardiogram measurement of the subject may comprise 12-lead electrocardiogram sites.
  • a method performed by at least one processing device comprises collecting electrophysiologic signals from a plurality of electrodes at a first set of locations on a body of a subject. The method also comprises generating a mapping of body surface potential of the subject based at least in part on correlating the electrophysiologic signals with one another, the correlations being based at least in part on estimates of distances between different ones of the first set of locations.
  • the method further comprises determining transformed electrophysiologic signals for a second set of locations on the body of the subject different than the first set of locations on the body of the subject, the transformed electrophysiologic signals being determined based at least in part on the generated mapping of the body surface potential of the subject.
  • the first set of locations may correspond to two or more different regions of a multihub patch interface, the electrophysiologic signals being collected from two or more hubs attached to the two or more different regions of the multi-hub patch interface.
  • the transformed electrophysiologic signals may characterize heart activity of the subject.
  • the second set of locations may comprise one or more lead locations for an electrocardiogram measurement of the subject.
  • the one or more lead locations for the electrocardiogram measurement of the subject may comprise 12-lead electrocardiogram sites.
  • a computer program product comprises a non-transitory processor-readable storage medium having stored therein program code of one or more software programs. The program code when executed by at least one processing device causes the at least one processing device to collect electrophysiologic signals from a plurality of electrodes at a first set of locations on a body of a subject.
  • the program code when executed by the at least one processing device also causes the at least one processing device to generate a mapping of body surface potential of the subject based at least in part on correlating the electrophysiologic signals with one another, the correlations being based at least in part on estimates of distances between different ones of the first set of locations.
  • the program code when executed by the at least one processing device further causes the at least one processing device to determine transformed electrophysiologic signals for a second set of locations on the body of the subject different than the first set of locations on the body of the subject, the transformed electrophysiologic signals being determined based at least in part on the generated mapping of the body surface potential of the subject.
  • the first set of locations may correspond to two or more different regions of a multihub patch interface, the electrophysiologic signals being collected from two or more hubs attached to the two or more different regions of the multi-hub patch interface.
  • the transformed electrophysiologic signals may characterize heart activity of the subject.
  • the second set of locations may comprise one or more lead locations for an electrocardiogram measurement of the subject.
  • the one or more lead locations for the electrocardiogram measurement of the subject may comprise 12-lead electrocardiogram sites.
  • FIG. 1 illustrates aspects of a modular physiologic monitoring system, according to an embodiment of the invention.
  • FIGS. 2A-2C illustrate a modular physiologic monitoring system, according to an embodiment of the invention.
  • FIGS. 3A-3E illustrate a wearable sensor system configured for monitoring and modeling health data, according to an embodiment of the invention.
  • FIG. 4 illustrates a block diagram of a system for performing electrophysiology (EP) mapping, according to an embodiment of the invention.
  • FIG. 5 illustrates a block diagram of a system for performing simultaneous EP mapping and Magnetic Resonance Imaging (MRI) to assess subject heart activity, according to an embodiment of the invention.
  • MRI Magnetic Resonance Imaging
  • FIG. 6 illustrates a process flow for simultaneous EP mapping and MRI performed by a base module, according to an embodiment of the invention.
  • FIG. 7 illustrates a multi-hub patch, according to an embodiment of the invention.
  • FIG. 8 illustrates placement of the multi-hub patch of FIG. 7 on a subject, according to an embodiment of the invention.
  • FIG. 9 illustrates another multi-hub patch, according to an embodiment of the invention.
  • FIG. 10 illustrates placement of the multi-hub patch of FIG. 9 on a subject, according to an embodiment of the invention.
  • FIG. 11 illustrates another placement of the multi-hub patch of FIG. 9 on a subject, according to an embodiment of the invention.
  • FIG. 12 illustrates a system including a set of wearable devices , according to an embodiment of the invention.
  • FIG. 13 illustrates process flow for generating a set of electrophysiological signals at a desired set of locations on the body of a subject, according to an embodiment of the invention.
  • One illustrative, non-limiting objective of this disclosure is to provide systems, devices, methods, and kits for monitoring physiologic and/or physical signals from a subject. Another illustrative, non-limiting objective is to provide simplified systems for monitoring subjects. Another illustrative, non-limiting objective is to provide comfortable long-term wearable systems for monitoring subjects. Yet another illustrative, non-limiting objective is to provide systems for simultaneous electrophysiology (EP) mapping and Magnetic Resonance Imaging (MRI) to assess heart activity of a subject.
  • EP electrophysiology
  • MRI Magnetic Resonance Imaging
  • a modular physiologic monitoring system in accordance with the present disclosure is configured to monitor one or more physiologic and/or physical signals, also referred to herein as physiologic parameters, of a subject (e.g., a human subject, a patient, an athlete, a trainer, an animal such as equine, canine, porcine, bovine, etc.).
  • the modular physiologic monitoring system may include one or more patches, each patch adapted for attachment to the body of the subject (e.g., attachable to the skin thereof, reversibly attachable, adhesively attachable, with a disposable interface and a reusable module, etc.).
  • the physiologic monitoring system may also include one or more modules, configured and dimensioned to mate with corresponding ones of the one or more patches, and to interface with the subject therethrough.
  • One or more of the modules may be configured to convey and/or store one or more physiologic and/or physical signals, signals derived therefrom, and/or metrics derived therefrom obtained via the interface with the subject.
  • a single patch may include or be configured for attachment to multiple modules, with each module managing a subset of a plurality of electrodes included on the patch.
  • Each module may include a power source (e.g., a battery, a rechargeable battery, an energy harvesting transducer, microcircuit, and an energy reservoir, a thermal gradient harvesting transducer, a kinetic energy harvesting transducer, a radio frequency energy harvesting transducer, a fuel cell, a biofuel cell, etc.), signal conditioning circuitry, communication circuitry, one or more sensors, or the like, configured to generate one or more signals (e.g., physiologic and/or physical signals), stimulus, etc.
  • a power source e.g., a battery, a rechargeable battery, an energy harvesting transducer, microcircuit, and an energy reservoir, a thermal gradient harvesting transducer, a kinetic energy harvesting transducer, a radio frequency energy harvesting transducer, a fuel cell, a biofuel cell, etc.
  • signal conditioning circuitry e.g., a sensor, a sensor, or the like, configured to generate one or more signals (e.g., physio
  • One or more of the patches may include one or more interconnects, configured and dimensioned so as to couple with one or more of the modules, said modules including a complementary interconnect configured and dimensioned to couple with the corresponding patch.
  • the patch may include a bioadhesive interface for attachment to the subject, the module retainable against the subject via interconnection with the patch.
  • the patch may be configured so as to be single use (e.g., disposable).
  • the patch may include a thin, breathable, stretchable laminate.
  • the laminate may include a substrate, a bioadhesive, one or more sensing or stimulating elements in accordance with the present disclosure, and one or more interconnects for coupling one or more of the sensing elements with one or more corresponding modules.
  • the patch may be sufficiently thin and frail, such that it may not substantially retain a predetermined shape while free standing.
  • the patch may be provided with a temporary stiffening film to retain the shape thereof prior to placement of the patch onto the body of a subject. Once adhered to the subject, the temporary stiffening film may be removed from the patch. While the patch is adhered to the subject, the shape and functionality of the patch may be substantially retained.
  • the now freestanding patch is sufficiently frail such that the patch can no longer substantially retain the predetermined shape (e.g., sufficiently frail such that the patch will not survive in a free standing state).
  • stretch applied to the patch while removing the patch from the subject may result in snap back once the patch is in a freestanding state that renders such a patch to crumple into a ball and no longer function.
  • Removal of the patch interface from the skin of the subject may result in a permanent loss in shape of the patch interface without tearing of the patch interface.
  • the interconnect may be sufficiently frail such that removal of the patch interface from the skin of the subject may result in a permanent loss of shape of the interconnect.
  • the patch may include a film (e.g., a substrate), with sufficiently high tear strength, such that, as the patch is peeled from the skin of a subject, the patch does not tear.
  • the ratio between the tear strength of the patch and the peel adhesion strength of the patch to skin e.g., tear strength: peel adhesion strength
  • tear strength: peel adhesion strength is greater than 8: 1, greater than 4: 1, greater than 2: 1, or the like.
  • the patch may include a bioadhesive with peel tack to mammalian skin of greater than 0.02 Newtons per millimeter (N/mm), greater than O.lN/mm, greater than 0.25N/mm, greater than 0.50N/mm, greater than 0.75N/mm, greater than 2N/mm, or the like.
  • peel tack may be approximately determined using an American Society for Testing and Materials (ASTM) standard test, ASTM D3330: Standard test method for peel adhesion of pressure-sensitive tape.
  • the patch may exhibit a tear strength of greater than 0.5N/mm, greater than IN/mm, greater than 2N/mm, greater than 8N/mm, or the like.
  • tear strength may be approximately determined using an ASTM standard test, ASTM D624: Standard test method for tear strength of conventional vulcanized rubber and thermoplastic elastomers.
  • a patch interface in accordance with the present disclosure may have a ratio between the tear strength of the patch and the peel tack of the adhesive to mammalian skin is greater than 8: 1, greater than 4: 1, greater than 2: 1, or the like.
  • the patch may be provided with a characteristic thickness of less than 50 micrometer (pm), less than 25pm, less than 12pm, less than 8pm, less than 4pm, or the like. Yet, in aspects, a balance between the thickness, stiffness, and tear strength may be obtained so as to maintain sufficiently high comfort levels for a subject, minimizing skin stresses during use (e.g., minimizing skin stretch related discomfort and extraneous signals as the body moves locally around the patch during use), minimizing impact on skin health, minimizing risk of rucking during use, and minimizing risk of maceration to the skin of a subject, while limiting risk of tearing of the patch during removal from a subject, etc.
  • a balance between the thickness, stiffness, and tear strength may be obtained so as to maintain sufficiently high comfort levels for a subject, minimizing skin stresses during use (e.g., minimizing skin stretch related discomfort and extraneous signals as the body moves locally around the patch during use), minimizing impact on skin health, minimizing risk of rucking during use, and minimizing risk of macer
  • the properties of the patch may be further altered so as to balance the hydration levels of one or more hydrophilic or amphiphilic components of the patch while attached to a subject.
  • Such adjustment may be advantageous to prevent over hydration or drying of an ionically conducting component of the patch, to manage heat transfer coefficients within one or more elements of the patch, to manage salt retention into a reservoir in accordance with the present disclosure, and/or migration during exercise, to prevent pooling of exudates, sweat, or the like into a fluid measuring sensor incorporated into the patch or associated module, etc.
  • the patch or a rate determining component thereof may be configured with a moisture vapor transmission rate of between 200 grams per meter squared per 24 hours (g/m 2 /24hrs) and 20,000g/m 2 /24hrs, between 500g/m 2 /24hrs and 12,000g/m 2 /24hrs, between 2,000g/m 2 /24hrs and 8,000g/m 2 /24hrs, or the like. Additional details regarding moisture management features of wearable devices (e.g., including patches of patch-module pairs) will be described below.
  • Such a configuration may be advantageous for providing a comfortable wearable physiologic monitor for a subject, while reducing material waste and/or cost of goods, preventing contamination or disease spread through uncontrolled re-use, and the like.
  • one or more patches and/or modules may be configured for electrically conducting interconnection, inductively coupled interconnection, capacitively coupled interconnection, with each other.
  • each patch and module interconnect may include complementary electrically conducting connectors, configured and dimensioned so as to mate together upon attachment.
  • the patch and module may include complementary coils or electrodes configured and dimensioned so as to mate together upon attachment.
  • Each patch or patch-module pair may be configured as a sensing device to monitor one or more local physiologic and/or physical parameters of the attached subject (e.g., local to the site of attachment, etc.), local environment, combinations thereof, or the like, and to relay such information in the form of signals to a host device (e.g., via a wireless connection, via a body area network connection, or the like), one or more patches or modules on the subject, or the like.
  • the patches are configured to allow sterile contact between a subject and the module, such that the module may be returned, sterilized and reused while the patch may be disposed of.
  • patches may be configured for multiple uses if desired for a particular implementation.
  • Each patch and/or patch-module pair may also or alternatively be configured as a stimulating device to apply a stimulus to the subject in response to signaling from the host device, the signaling being based on analysis of the physiologic and/or physical parameters of the subject measured by the sensing device(s).
  • the host device may be configured to coordinate information exchange to/from each module and/or patch, and to generate one or more physiologic signals, physical signals, environmental signals, kinetic signals, diagnostic signals, alerts, reports, recommendation signals, commands, combinations thereof, or the like for the subject, a user, a network, an electronic health record (EHR), a database (e.g., as part of a data management center, an EHR, a social network, etc.), a processor, combinations thereof, or the like.
  • the host device may include features for recharging and/or performing diagnostic tests on one or more of the modules.
  • a host device in accordance with the present disclosure may be integrated into a bedside alarm clock, housed in an accessory, within a purse, a backpack, a wallet, or may be included in a mobile computing device, a smartphone, a tablet computer, a pager, a laptop, a local router, a data recorder, a network hub, a server, a secondary mobile computing device, a repeater, a combination thereof, or the like.
  • a system in accordance with the present disclosure may include a plurality of substantially similar modules (e.g., generally interchangeable modules, but with unique identifiers), for coupling with a plurality of patches or different portions or regions of a single patch, each patch, optionally different from the other patches in the system (e.g., potentially including alternative sensors, sensor types, sensor configurations, electrodes, electrode configurations, etc.).
  • Each patch may include one or more interconnects suitable for attachment to an associated module.
  • the module may validate the type and operation of the patch to which it has been mated.
  • the module may then initiate monitoring operations on the subject via the attached patch, communicate with one or more other patches on the subject, a hub, etc.
  • the data collection from each module may be coordinated through one or more modules and/or with a host device in accordance with the present disclosure.
  • the modules may report a timestamp along with the data in order to synchronize data collection across multiple patch-module pairs on the subject, between subjects, etc.
  • a hot swappable replacement e.g., replacement during a monitoring procedure
  • Such a configuration may be advantageous for performing redundant, continuous monitoring of a subject, and/or to obtain spatially relevant information from a plurality of locations on the subject during use.
  • One or more devices in the network may include a time synchronization service, the time synchronization service configurable so as to periodically align the local time sources of each device to those of each of the other devices in the network.
  • the time synchronization may be performed every second, every ten seconds, every thirty seconds, every minute, or the like.
  • one or more local devices may be coupled to an external time source such as an Internet accessible time protocol, or a geolocation-based time source. Such information may be brought into the network so as to help align a global time reference for devices in the network. Such information may propagate through the network devices using the time synchronization service.
  • one or more metrics measured from a subject in connection with one or more devices in the network may be time aligned with one or more metrics from a different subject in the network.
  • events that can simultaneously affect multiple subjects can be registered and higher level event classification algorithms are configured so as to generate an appropriate alert based on the metrics measured.
  • an event may include a loud audible event, or a physiological response to an event
  • the event classification algorithm is configured so as to increase the priority of an alert if the number of subjects affected by the event increases beyond a set number.
  • the modules and/or patches may include corresponding interconnects for coupling with each other during use.
  • the interconnects may include one or more connectors, configured such that the modules and patches may only couple in a single unique orientation with respect to each other.
  • the modules may be color coded by function.
  • a temporary stiffening element attached to a patch may include instructions, corresponding color coding, etc. so as to assist a user or subject with simplifying the process of monitoring.
  • one or more patches and/or modules may be used to provide a stimulus to the subject, as will be described in further detail below.
  • an interface e.g., a patch in accordance with the present disclosure
  • the interface or patch may include a substrate, an adhesive coupled to the substrate formulated for attachment to the skin of a subject, and one or more sensors and/or electrodes each in accordance with the present disclosure coupled to the substrate, arranged, configured, and dimensioned to interface with the subject.
  • the substrate may be formed from an elastic or polymeric material, such that the patch is configured to maintain operation when stretched to more than 25%, more than 50%, or more than 80%.
  • an isolating patch for providing a barrier between a handheld monitoring device with a plurality of contact pads and a subject, including a flexible substrate with two surfaces, a patient facing surface and an opposing surface, and an electrically and/or ionically conducting adhesive coupled to at least a portion of the patient facing surface configured so as to electrically and mechanically couple with the subject when placed thereupon, wherein the conducting adhesive is exposed within one or more regions of the opposing surface of the substrate, the regions patterned so as to substantially match the dimensions and layout of the contact pads.
  • the conducting adhesive may include an anisotropically conducting adhesive, with the direction of conduction oriented substantially normal to the surfaces of the substrate.
  • the adhesive may be patterned onto the substrate so as to form one or more exposed regions of the substrate, one or more of the sensors and/or electrodes arranged within the exposed regions.
  • One or more of the electrodes may include an inherently or ionically conducting gel adhesive.
  • one or more of the electrodes may include an electrode feature arranged so as to improve the electrical connection between the electrode and the skin upon placement on a subject.
  • the improved electrical connection may be achieved after pressure is applied to the electrode (e.g., after the patch is secured to the subject and then a pressure is applied to the electrode).
  • the electrode feature may include one or more microfibers, barbs, microneedles, or spikes to penetrate into a stratum corneum of the skin.
  • the electrode feature may be configured to penetrate less than 2 mm into the skin, less than 1 mm, less than 0.5 mm, less than 0.2 mm, or the like during engagement therewith.
  • a gel adhesive in accordance with the present disclosure located adjacent to the electrode features may be configured to maintain the improved electrical connection to the skin for more than 1 hour, more than 1 day, or more than 3 days after the electrode contacts the skin or pressure is applied to the electrode.
  • a patch interface in accordance with the present disclosure may include one or more stretchable electrically conducting traces attached to the substrate, arranged so as to couple one or more of the sensors and/or electrodes with one or more of the interconnects.
  • an interconnect may include a plurality of connectors, the connectors physically connected to each other through the substrate.
  • the patch may include an isolating region arranged so as to isolate one or more of the connectors from the skin while the patch is engaged therewith.
  • a device for monitoring a physiologic, physical, and/or electrophysiological signal from a subject.
  • the module may include a housing, a printed circuit board (PCB) including one or more microcircuits, and an interconnect configured for placement of the device onto a subject interface (e.g., a patch in accordance with the present disclosure).
  • the printed circuit board may constitute at least a portion of the housing in some embodiments.
  • the module may include a three-dimensional antenna coupled to the microcircuits (e.g., coupled with a transceiver, transmitter, radio, etc. included within the microcircuits). In aspects, the antenna may be printed onto or embedded into the housing.
  • the antenna may be printed on an interior wall of or embedded into the housing, the circuit board providing a ground plane for the antenna.
  • the housing may be shaped like a dome and the antenna may be patterned into a spiraling helix centered within the dome.
  • a module in accordance with the present disclosure may include a sensor coupled with one or more of the microcircuits, the sensor configured to interface with the subject upon attachment of the module to the patch interface.
  • the module may include a sensor and/or microelectronics configured to interface with a sensor included on a corresponding patch interface.
  • one or more of the sensors may include an electrophysiologic sensor, a temperature sensor, a thermal gradient sensor, a barometer, an altimeter, an accelerometer, a gyroscope, a humidity sensor, a magnetometer, an inclinometer, an oximeter, a colorimetric monitor, a sweat analyte sensor, a galvanic skin response sensor, an interfacial pressure sensor, a flow sensor, a stretch sensor, a microphone, a combination thereof, or the like.
  • an electrophysiologic sensor a temperature sensor, a thermal gradient sensor, a barometer, an altimeter, an accelerometer, a gyroscope, a humidity sensor, a magnetometer, an inclinometer, an oximeter, a colorimetric monitor, a sweat analyte sensor, a galvanic skin response sensor, an interfacial pressure sensor, a flow sensor, a stretch sensor, a microphone, a combination thereof, or the like.
  • the module may be hermetically sealed.
  • the module and/or patch interface may include a gasket coupled to the circuit board or the substrate, the gasket formed so as to isolate the region formed by the module interconnect and the patch from a surrounding environment, when the module is coupled with the patch.
  • the module interconnect may include an electrically conducting magnetic element
  • the patch interface may include one or more ferromagnetic regions coupled to the substrate, the magnetic elements arranged so as to physically and/or electrically couple the module to the patch interface when the magnetic elements are aligned with the ferromagnetic regions.
  • the ferromagnetic regions may be formed from stretchable pseudo elastic material and/or may be printed onto the substrate.
  • the module and/or the patch interface may include one or more fiducial markings to visually assist with the alignment of the module to the patch during coupling thereof.
  • kits for monitoring a physiologic, physical, and/or electrophysiological signal from a subject including one or more patches in accordance with the present disclosure, one or more modules in accordance with the present disclosure, a recharging bay in accordance with the present disclosure, and one or more accessories in accordance with the present disclosure.
  • One or more of the accessories may include an adhesive removing agent configured to facilitate substantially pain free removal of one or more of the patches from a subject.
  • a service system for managing the collection of physiologic data from a customer including a customer data management service, configured to generate and/or store the customer profile referencing customer preferences, data sets, and/or monitoring sessions, an automated product delivery service configured to provide the customer with one or more monitoring products or supplies in accordance with the present disclosure, and a datacenter configured to store, analyze, and/or manage the data obtained from the customer during one or more monitoring sessions.
  • the service system may include a report generating service configured to generate one or more monitoring reports based upon the data obtained during one or more monitoring sessions, a report generating service coupled to the datacenter configured to generate one or more monitoring reports based upon the data obtained during one or more monitoring sessions, and/or a recurrent billing system configured to bill the customer based upon the number or patches consumed, the data stored, and/or the reports generated throughout the course of one or more monitoring sessions.
  • a report generating service configured to generate one or more monitoring reports based upon the data obtained during one or more monitoring sessions
  • a report generating service coupled to the datacenter configured to generate one or more monitoring reports based upon the data obtained during one or more monitoring sessions
  • a recurrent billing system configured to bill the customer based upon the number or patches consumed, the data stored, and/or the reports generated throughout the course of one or more monitoring sessions.
  • a method for monitoring one or more physiologic and/or electrophysiological signals from a subject including attaching one or more soft breathable and hypoallergenic devices to one or more sites on the subject, obtaining one or more local physiologic and/or electrophysiological signals from each of the devices, and analyzing the signals obtained from each of the devices to generate a metric, diagnostic, report, and/or additional signals therefrom.
  • the method may include hot swapping one or more of the devices without interrupting the step of obtaining, and/or calibrating one or more of the devices while on the subject.
  • the step of calibrating may be performed with an additional medical device (e.g., a blood pressure cuff, a thermometer, a pulse oximeter, a cardiopulmonary assessment system, a clinical grade EKG diagnostic system, etc.).
  • the method may include determining the position and/or orientation of one or more of the devices on the subject, and/or determining the position and/or orientation from a photograph, a video, or a surveillance video.
  • one or more steps of a method in accordance with the present disclosure may be performed at least in part by a device, patch interface, module, and/or system each in accordance with the present disclosure.
  • a system for measuring blood pressure of a subject in an ambulatory setting including an EKG device in accordance with the present disclosure (e.g., a patch/module pair in accordance with the present disclosure configured to measure local electrophysiological signals in adjacent tissues), configured for placement onto a torso of the subject, the EKG device configured to measure an electrocardiographic signal from the torso of the subject so as to produce an EKG signal, one or more pulse devices (e.g., patch/module pairs in accordance with the present disclosure configured to measure local blood flow in adjacent tissues) each in accordance with the present disclosure, configured for placement onto one or more sites on one or more extremities of the subject, each of the pulse devices configured to measure a local pulse at the placement site so as to produce one or more pulse signals; and a processor included in or coupled to one or more of the EKG device and the pulse devices, the processor configured to receive the EKG signal, the pulse signals, and/or signals generated therefrom, the processor including an algorithm, the algorithm configured to analyze one
  • the system for monitoring blood pressure of a subject may include a blood pressure cuff configured to produce a calibration signal, the processor configured to generate one or more of the calibration parameters, from the calibration signal in combination with the EKG signal, and pulse signals.
  • one or more of the devices may include an orientation sensor, the orientation sensor configured to obtain an orientation signal, the processor configured to receive the orientation signal or a signal generated therefrom, and to incorporate the orientation signal into the analysis.
  • orientation sensors include one or more of an altimeter, a barometer, a tilt sensor, a gyroscope, combinations thereof, or the like.
  • a system for measuring the effect of an impact on physiologic state of a subject may include an electroencephalogram (EEG) device (e.g., a patch/module pair in accordance with the present disclosure configured to measure local electrophysiological signals associated with brain activity in adjacent tissues) in accordance with the present disclosure, configured for placement behind an ear, on the forehead, near a temple, onto the neck of the subject, or the like, the EEG device configured to measure an electroencephalographic signal from the head of the subject so as to produce an EEG signal, and configured to measure one or more kinetic and/or kinematic signals from the head of the subject so as to produce an impact signal, and a processor included in or coupled to the EEG device, the processor configured to receive the EEG signal, the impact signals, and/or signals generated therefrom, the processor including an algorithm, the algorithm configured to analyze the impact signals to determine if the subject has suffered an impact, to separate the signals into pre impact and post impact portions and to compare the pre and post impact portions of the EEG signal, to determine the
  • the EEG device may include additional sensors such as a temperature sensor configured to generate a temperature signal from the subject or a signal generated therefrom, the processor configured to receive the temperature signal and to assess a thermal state of the subject therefrom.
  • the EEG device may include a hydration sensor configured to generate a fluid level signal from the subject, the processor configured to receive the fluid level signal or a signal generated therefrom, and to assess the hydration state of the subject therefrom.
  • the EEG device and/or the processor may include or be coupled to a memory element, the memory element including sufficiently large space to store the signals for a period of 3 minutes, 10 minutes, 30 minutes, or 1 hour.
  • the system for measuring the effect of an impact on physiologic state of a subject may include an EKG device (e.g., a patch/module pair in accordance with the present disclosure configured to measure local electrophysiological signals in adjacent tissues) in accordance with the present disclosure, the EKG device configured for placement onto the torso or neck of the subject, the EKG device configured to measure an electrophysiological signal pertaining to cardiac function of the subject so as to produce an EKG signal, the processor configured to receive the EKG signal or a signal generated therefrom, the algorithm configured so as to incorporate the EKG signal into the assessment.
  • the processor may be configured to extract a heart rate variability (HRV) signal from the EKG signal, a pre impact and post impact portion of the HRV signal compared to determine at least a portion of the effect of the impact.
  • HRV heart rate variability
  • a system for assessing a sleep state of a subject including an electromyography (EMG)/electrooculography (EOG) device (e.g., a patch/module pair in accordance with the present disclosure configured to measure local electromyographic and/or electrooculographic signals from adjacent tissues), in accordance with the present disclosure, configured for placement behind an ear, on a forehead, substantially around an eye, near a temple, or onto a neck of the subject, the EMGZEOG device configured to measure one or more electromyographic and/or electrooculographic signals from the head or neck of the subject so as to produce an EMGZEOG signal, and a processor included in or coupled to the EMGZEOG device, the processor configured to receive the EMGZEOG signal, and/or signals generated therefrom, the processor including an algorithm, the algorithm configured to analyze EMGZEOG signal, to determine the sleep state of the subject.
  • EMG electromyography
  • EOG electroooculography
  • the EMGZEOG device may include a microphone, the microphone configured to obtain an acoustic signal from the subject, the processor configured to receive the acoustic signal or a signal generated therefrom, the algorithm configured so as to incorporate the acoustic signal into the assessment.
  • the system may include a sensor for evaluating oxygen saturation (SpO2) at one or more sites on the subject to obtain an oxygen saturation signal from the subject, the processor configured to receive the oxygen saturation signal or a signal generated therefrom, the algorithm configured so as to incorporate the oxygen saturation signal into the assessment.
  • SpO2 oxygen saturation
  • the processor may include a signal analysis function, the signal analysis function configured to analyze the EMGZEOG signals, the acoustic signal, and/or the oxygen saturation signal to determine the sleep state of the subject, identify snoring, identify a sleep apnea event, identify a bruxism event, identify a rapid eye movement (REM) sleep state, identify a sleep walking state, a sleep talking state, a nightmare, or identify a waking event.
  • the system may include a feedback mechanism, configured to interact with the subject, a user, a doctor, a nurse, a partner, a combination thereof, or the like.
  • the processor may be configured to provide a feedback signal to the feedback mechanism based upon the analysis of the sleep state of the subject.
  • the feedback mechanism may include a transducer, a loudspeaker, tactile actuator, a visual feedback means, a light source, a buzzer, a combination thereof, or the like to interact with the subject, the user, the doctor, the nurse, the partner, or the like.
  • a modular physiologic monitoring system includes one or more sensing devices, which may be placed or attached to one or more sites on the subject. Alternatively or additionally, one or more sensing devices may be placed “off’ the subject, such as one or more sensors (e.g., cameras, acoustic sensors, etc.) that are not physically attached to the subject.
  • the sensing devices are utilized to establish whether or not an event is occurring and to determine one or more characteristics of the event by monitoring and measuring physiologic parameters of the subject. The determination of whether an event has occurred or is occurring may be made by a device that is at least partially external and physically distinct from the one or more sensing devices, such as a host device in wired or wireless communication with the sensing devices as described below with respect to FIG. 1.
  • the modular physiologic monitoring system includes one or more stimulating devices, which again may be any combination of devices that are attached to the subject or placed “off’ the subject, to apply a stimulus to the subject in response to a detected event.
  • stimulating devices may be any combination of devices that are attached to the subject or placed “off’ the subject, to apply a stimulus to the subject in response to a detected event.
  • Various types of stimulus may be applied, including but not limited to stimulating via thermal input, vibration input, mechanical input, a compression or the like with an electrical input, etc.
  • the sensing devices of a modular physiologic monitoring system may be used to monitor one or more physiologic functions or parameters of a subject, as will be described in further detail below.
  • the sensing devices of the modular physiologic monitoring system, or a host device configured to receive data or measurements from the sensing devices may be utilized to monitor for one or more events (e.g., through analysis of signals measured by the sensing devices, from metrics derived from the signals, etc.).
  • the stimulating devices of the modular physiologic monitoring system may be configured to deliver one or more stimuli (e.g., electrical, vibrational, acoustic, visual, etc.) to the subject.
  • the stimulating devices may receive a signal from one or more of the sensing devices or a host device, and provide the stimulation in response to the received signal.
  • FIG. 1 shows aspects of a modular physiologic monitoring system in accordance with the present disclosure.
  • a subject 1 is shown with a number of patches and/or patchmodule pairs each in accordance with the present disclosure attached thereto at sites described below, a host device 145 in accordance with the present disclosure, a feedback/user device 147 in accordance with the present disclosure displaying some data 148 based upon signals obtained from the subject 1, and one or more feedback devices 135, 140, in accordance with the present disclosure configured to convey to the subject 1 one or more aspects of the signals or information gleaned therefrom.
  • the feedback devices 135, 140 may also or alternatively function as stimulating devices.
  • the host device 145, the user device 147, the patches and/or patch-module pairs, and/or the feedback devices 135, 140 may be configured for wireless communication 146, 149 during a monitoring session.
  • a patch-module pair may be adapted for placement almost anywhere on the body of a subject 1.
  • some sites may include attachment to the cranium or forehead 131, the temple, the ear or behind the ear 50, the neck, the front, side, or back of the neck 137, a shoulder 105, a chest region with minimal muscle mass 100, integrated into a piece of ornamental jewelry 55 (may be a host, a hub, a feedback device, etc.) on a necklace 130, arrangement on the torso HOa-c, arrangement on the abdomen 80 for monitoring movement or breathing, below the rib cage 90 for monitoring respiration (generally on the right side of the body to substantially reduce EKG influences on the measurements), on a muscle such as a bicep 85, on a wrist or in combination with a wearable computing device 60 on the wrist (e.g., a smart watch, a fitness band, etc.), on a buttocks 25, on a thigh 75, on a
  • Additional placement sites on the abdomen, perineal region 142a-c, genitals, urogenital triangle, anal triangle, sacral region, inner thigh 143, or the like may be advantageous in the assessment of autonomic neural function of a subject.
  • Such placements regions may be advantageous for assessment of parasympathetic nervous system (PNS) activity, somatosensory function, assessment of sympathetic nervous system (SNS) functionality, etc.
  • PNS parasympathetic nervous system
  • SNS sympathetic nervous system
  • Placement sites on the nipples, areola, lips, labia, clitoris, penis, the anal sphincter, levator ani muscle, over the ischiocavernous muscle, deep transverse perineal muscle, labium minus, labium majus, one or more nerves near the surface thereof, posterior scrotal nerves, perineal membrane, perineal nerves, superficial transverse perineal nerves, dorsal nerves, inferior rectal nerves, etc. may be advantageous for assessment of autonomic neural ablation procedures, autonomic neural modulation procedures, assessment of the PNS of a subject, assessment of sexual dysfunction of a subject, etc.
  • a facial muscle e.g., a nasalis, temporalis, zygonaticus minor/major, orbicularis oculi, occipitofrontalis
  • each of the patch-module pairs is assumed to include a patch to which a single hub or module is attached.
  • multiple hubs or modules may be configured for attachment to a single patch.
  • a plurality of electrodes may be placed at different known locations (e.g., different regions of the patch interface), with different hubs/modules being configured to manage subsets of the plurality of electrodes in such different locations (e.g., different regions of the patch interface).
  • the patch interface is formed from a comfortable material to facilitate monitoring.
  • the patch interface of a multi-hub or multi-module patch also solves issues related to wiring and routing, which can be difficult if only one hub or module is used to manage a larger number of channels of electrodes.
  • the hubs/modules which are attached to the multi-hub patches include non-ferrous batteries as power sources. Further, lead lengths between electrodes and the hub/module interconnections are kept short enough such that they do not heat up (e.g., beyond some designated threshold) during MRI to thus have low voltage and low heat. This also advantageously provides a better noise profile and more extensive coverage.
  • Multi -hub patches may also use signaling from different sets of electrodes, which are collected by different hubs/modules, in order to obtain timing signals (e.g., for ECG) relative to the subject breathing (or holding breath) during MRI.
  • a time synchronization service may be utilized to coordinate the different sets of electrodes on the multi-hub patch with one another, and possibly with other sensors or devices (e.g., on other multi-hub patches, on other patch-module pairs, etc.).
  • Data may be pulled from local global positioning system (GPS) sensors for time synchronization.
  • GPS global positioning system
  • multi-hub patches may be designed for various target use cases.
  • a multi-hub patch may be designed with a sufficient area to cover a torso/chest of a subject in order to map where a heart sits within the chest of the subject, and provide heart access.
  • Models and three-dimensional (3D) simulations may be used to determine what a cardiac rhythm would look like in the chest of a subject (e.g., where such models may be customized based on individual patient parameters such as height, weight, body type, etc.) and how signaling would spread.
  • the electrodes in different regions of the multi- hub patch can then perform monitoring and, given their known locations relative to one another on the multi-hub patch, can be used to measure/confirm the model (e.g., by analyzing electric fields on a surface of the torso/chest of the subject through knowledge of what electric fields in the heart of the subject, when propagated, would result in the measured electric fields at the different regions of the multi-hub patch). While various embodiments are described herein with respect to multi-hub patches designed for attachment to a torso/chest of a subject that can facilitate EP mapping and MRI applications, various other types of multi-hub patches may be used.
  • a multi-hub patch may be used for attachment to a temple of a subject, with groups of electrodes in left, middle and right regions of the multi-hub patch for capturing measurements across the temple of the subject without requiring routing of traces or other wiring across the entire temple of the subject.
  • a multi-hub patch may be used for attachment to a back of the subject, with the hub/module interconnections being arranged such that it is comfortable for the subject to lie down while wearing the patch (e.g., the hubs/modules may be placed on the back/side without being bothersome to the subject).
  • the hub/modules may be placed on the back/side without being bothersome to the subject.
  • a system in accordance with the present disclosure may be configured to monitor one or more physiologic parameters of the subject 1 before, during, and/or after one or more of, a stress test, consumption of a medication, exercise, a rehabilitation session, a massage, driving, a movie, an amusement park ride, sleep, intercourse, a surgical, interventional, or non-invasive procedure, a neural remodeling procedure, a denervation procedure, a sympathectomy, a neural ablation, a peripheral nerve ablation, a radio- surgical procedure, an interventional procedure, a cardiac repair, administration of an analgesic, a combination thereof, or the like.
  • a system in accordance with the present disclosure may be configured to monitor one or more aspects of an autonomic neural response to a procedure, confirm completion of the procedure, select candidates for a procedure, follow up on a subject after having received a procedure, assess the durability of a procedure, or the like (e.g., such as wherein the procedure is a renal denervation procedure, a carotid body denervation procedure, a hepatic artery denervation procedure, a LUTs treatment, a bladder denervation procedure, a urethral treatment, a prostate ablation, a prostate nerve denervation procedure, a cancer treatment, a pain block, a neural block, a bronchial denervation procedure, a carotid sinus neuromodulation procedure, implantation of a neuromodulation device, tuning of a neuromodulation device, etc.).
  • the procedure is a renal denervation procedure, a carotid body denervation procedure, a hepatic artery den
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  • PCT application serial no. PCT/US2021/028611, published as WO 2021/216847 and titled “Visualizing Physiologic Data Obtained from Subjects”
  • PCT application serial no. PCT/US2021/033442, published as WO 2021/236949 and titled “Non-Invasive Detection of Anomalous Physiologic Events Indicative of Hypovolemic Shock of a Subject”
  • PCT/US2021/041414 published as WO 2022/015719 and titled “Wearable Sensor System Configured for Monitoring and Modeling Health Data”
  • PCT application serial no. PCT/US2021041418 published as WO 2022/015722 and titled “Wearable Sensor System Configured for Facilitating Telemedicine Management”
  • PCT application serial no. PCT/US2021/041420 published as WO 2022/015724 and titled “Wearable Sensor System Configured for Alerting First Responders and Local Caregivers,” the disclosures of which are incorporated by reference herein in their entirety.
  • modular physiologic monitoring systems may include sensing and stimulating devices that are physically distinct, such as sensing and stimulating devices that are physically attached to a subject at varying locations.
  • the sensing and stimulating devices may include different ones of the patch-module pairs described above with respect to FIG. 1.
  • one or more devices may provide both monitoring and stimulating functionality.
  • one or more of the patch-module pairs described above with respect to FIG. 1 may be configured to function as both a sensing device and a stimulating device. It is to be appreciated, however, that embodiments are not limited solely for use with the patch-module pairs of FIG. 1 as sensing and stimulating devices.
  • Various other types of sensing and stimulating devices may be utilized, including but not limited to sensors that are “off-body” with respect to subject 1.
  • the sensing and/or stimulating devices of a modular physiologic monitoring system may be configured for radio frequency (RF) or other wireless and/or wired connection with one another and/or a host device. Such RF or other connection may be used to transmit or receive feedback parameters or other signaling between the sensing and stimulating devices.
  • the feedback may be provided based on measurements of physiologic parameters that are obtained using the sensing devices to determine when events related to cardiac output are occurring.
  • Various thresholds for stimulation that are applied by the stimulating devices may, in some embodiments, be determined based on such feedback. Thresholds may relate to the amplitude or frequency of electric or other stimulation. Thresholds may also be related to whether to initiate stimulation by the stimulating devices based on the feedback.
  • the sensing devices may monitor the physiologic response of the subject. If stimulation is successful in achieving a desired response, the stimulation may be discontinued. Otherwise, the type, timing, etc. of stimulation may be adjusted.
  • a user of the modular physiologic monitoring system may set preferences for the stimulus type, level, and/or otherwise personalize the sensation during a setup period or at any point during use of the modular physiologic monitoring system.
  • the user of the modular physiologic monitoring system may be the subject being monitored and stimulated by the sensing devices and stimulating devices, or a doctor, nurse, physical therapist, medical assistant, caregiver, etc. of the subject being monitored and stimulated.
  • the user may also have the option to disconnect or shut down the modular physiologic monitoring system at any time, such as via operation of a switch, pressure sensation, voice operated instruction, etc.
  • Stimulus or feedback which may be provided via one or more stimulating devices in a modular physiologic monitoring system may be in various forms, including physical stimulus (e.g., electrical, thermal, vibrational, pressure, stroking, a combination thereof, or the like), optical stimulus, acoustic stimulus, etc.
  • Physical stimulus may be provided in the form of negative feedback, such as in a brief electric shock or impulse as described above. Data or knowledge from waveforms applied in conducted electrical weapons (CEWs), such as in electroshock devices, may be utilized to avoid painful stimulus. Physical stimulus may also be provided in the form of positive feedback, such as in evoking pleasurable sensations by combining non-painful electrical stimulus with pleasant sounds, music, lighting, smells, etc. Physical stimulus is not limited solely to electrical shock or impulses. In other embodiments, physical stimulus may be provided by adjusting temperature or other stimuli, such as in providing a burst of cool or warm air, a burst of mist, vibration, tension, stretch, pressure, etc.
  • Feedback provided via physical stimulus as well as other stimulus described herein may be synchronized with, initiated by or otherwise coordinated or controlled in conjunction with one or more monitoring devices (e.g., a host device, one or more sensing devices, etc.).
  • the monitoring devices may be connected to the stimulating devices physically (e.g., via one or more wires or other connectors), wirelessly (e.g., via radio or other wireless communication), etc.
  • Physical stimulus may be applied to various regions of a subject, including but not limited to the wrist, soles of the feet, palms of the hands, nipples, forehead, ear, mastoid region, the skin of the subject, etc.
  • Optical stimulus may be provided via one or more stimulating devices.
  • the optical stimulus may be positive or negative (e.g., by providing pleasant or unpleasant lighting or other visuals).
  • Acoustic stimulus similarly may be provided via one or more stimulating devices, as positive or negative feedback (e.g., by providing pleasant or unpleasant sounds).
  • Acoustic stimulus may take the form of spoken words, music, etc.
  • Acoustic stimulus in some embodiments may be provided via smart speakers or other electronic devices such as Amazon Echo®, Google Home®, Apple Home Pod®, etc.
  • the stimulus itself may be provided so as to elicit a particular psychophysical or psychoacoustic effect in the subject, such as directing the subject to stop an action, to restart an action (such as breathing), to adjust an action (such as a timing between a step and a respiratory action, between a muscle contraction and a leg position, etc.).
  • the modular physiologic monitoring system may operate in a therapeutic mode, in that stimulation is provided when one or more cardiac parameters of a subject indicate some event (e.g., actual, imminent or predicted failure or worsening).
  • the modular physiologic monitoring system may also operate as or provide a type of cardiac “pacemaker” in other embodiments.
  • the modular physiologic monitoring system has the potential to reduce the frequency of cardiac events, or to possibly avoid certain cardiac events altogether.
  • a modular physiologic monitoring system may provide functionality for timing and synchronizing periodic compression and relaxation of microvascular blood vessel networks with cardiac output. Such techniques may be utilized to respond to a type of failure event as indicated above. Alternatively or additionally, such techniques may be provided substantially continuously, so as to improve overall cardiac performance (e.g., blood flow) with the same or less cardiac work.
  • a modular physiologic monitoring system may be configured to provide multi-modal stimuli to a subject.
  • Multi-modal approaches use one or more forms of stimulation (e.g., thermal and electrical, mechanical and electrical, etc.) in order to mimic another stimulus to trick local nerves into responding in the same manner to the mimicked stimulus.
  • multi-modal stimulus or input may be used to enhance a particular stimulus. For example, adding a mimicked electrical stimulus may enhance the effect of a thermal stimulus.
  • Modular physiologic monitoring systems may use pulses across space and time (e.g., frequency, pulse trains, relative amplitudes, etc.) to mimic vibration, comfort or discomfort, mild or greater pain, wet sensation, heat/cold, training neuroplasticity, taste (e.g., using a stimulating device placed in the mouth or on the tongue of a subject to mimic sour, sweet, salt, bitter or umami flavor), tension or stretching, sound or acoustics, sharp or dull pressure, light polarization (e.g., linear versus polar, the “Haidinger Brush”), light color or brightness, etc.
  • pulses across space and time e.g., frequency, pulse trains, relative amplitudes, etc.
  • Stimulus amplification may also be provided by one or more modular physiologic monitoring systems using multi-modal input.
  • Stimulus amplification represents a hybrid approach, wherein a first type of stimulus may be applied and a second, different type of stimulus provided to enhance the effect of the first type of stimulus.
  • a first stimulus may be provided via a heating element, where the heating element is augmented by nearby electrodes or other stimulating devices that amplify and augment the heating stimulus using electrical mimicry in a pacing pattern.
  • Electrical stimulus may also be used as a supplement or to mimic various other types of stimulus, including but not limited to vibration, heat, cold, etc.
  • Different, possibly unique, stimulation patterns may be applied to the subject, with the central nervous system and peripheral nervous system interpreting such different or unique stimulation patterns as different stimulus modalities.
  • stimulus augmentation is sensing a “real” stimulus, measuring the stimulus, and constructing a proportional response by mimicry such as using electric pulsation.
  • the real stimulus such as sensing heat or cold from a Peltier device, may be measured by electrical-thermal conversion.
  • This real stimulus may then be amplified using virtual mimicry, which may provide energy savings and the possibility of modifying virtual stimulus to modify the perception of the real stimulus.
  • the stimulating devices in a modular physiologic monitoring system include an electrode array that attaches (e.g., via an adhesive or which is otherwise held in place) to a preferred body part.
  • One or more of the stimulating devices may include a multiplicity of both sensing and stimulation electrodes, including different types of sensing and/or stimulation electrodes.
  • the sensing electrodes on the stimulation devices may be distinct from the sensing devices in the modular physiologic monitoring system in that the sensing devices in the modular physiologic monitoring system may be used to measure physiologic parameters of the subject while the sensing electrodes on the stimulation devices in the modular physiologic monitoring system may be utilized to monitor the application of a stimulus to the subject.
  • a test stimulus may be initiated in a pattern in the electrode array, starting from application via one or a few of the stimulation electrodes and increasing in number over time to cover an entire or larger portion of the electrode array.
  • the test stimulus may be used to determine the subject’s response to the applied stimulation.
  • Sensing electrodes on the stimulation devices may be used to monitor the application of the stimulus.
  • the electrode array may also be used to record a desired output (e.g., physiologic parameters related to cardiac output).
  • a desired output e.g., physiologic parameters related to cardiac output.
  • one or more of the electrodes in the array may be configured so as to measure the local evoked response associated with the stimulus itself.
  • Such an approach may be advantageous to confirm capture of the target nerves during use.
  • the stimulus parameters including amplitude, duration, pulse number, etc. may be adjusted while ensuring that the target nerves are enlisted by the stimulus in use.
  • the test stimulus may migrate or be applied in a pattern to different electrodes at different locations in the electrode array.
  • the response to the stimulus may be recorded or otherwise measured, using the sensing devices in the modular physiologic monitoring system and/or one or more of the sensing electrodes of the stimulating devices in the modular physiologic monitoring system.
  • the response to the test stimulus may be recorded or analyzed to determine an optimal sensing or application site for the stimulus to achieve a desired effect or response in the subject.
  • the test stimulus may be utilized to find an optimal sensing (e.g., dermatome driver) location. This allows for powerful localization for optimal pacing or other application of stimulus, which may be individualized for different subjects.
  • a stimulating device applied to the subject via an adhesive may be in the form of a disposable or reusable unit, such as a patch and or patch-module or patch/hub pair as described above with respect to FIG. 1.
  • An adhesively applied stimulating device in some embodiments, includes a disposable interface configured so as to be thin, stretchable, able to conform to the skin of the subject, and sufficiently soft for comfortable wear.
  • the disposable interface may be built from very thin, stretchable and/or breathable materials, such that the subject generally does not feel the device on his or her body.
  • the adhesively applied stimulating device also includes a means for interfacing with the subject through an adhesive interface and/or a window in the adhesive interface.
  • Such means may include a plurality of electrodes that are coupled with a reusable component of the adhesively applied stimulating device and that are coupled to the body of the subject through the adhesive interface.
  • the means may also or alternatively include: a vibrating actuator to provide vibration normal to and/or transverse to the surface of the skin on which the adhesively applied stimulating device is attached to the subject; a thermal device such as a Peltier device, a heating element, a cooling element, an RF heating circuit, an ultrasound source, etc.; a means for stroking the skin such as a shape memory actuator, an electroactive polymer actuator, etc.; a means for applying pressure to the skin such as a pneumatic actuator, a hydraulic actuator, etc.
  • a vibrating actuator to provide vibration normal to and/or transverse to the surface of the skin on which the adhesively applied stimulating device is attached to the subject
  • a thermal device such as a Peltier device, a heating element, a cooling element, an RF heating circuit, an ultrasound source, etc.
  • a means for stroking the skin such as a shape memory actuator, an electroactive polymer actuator, etc.
  • a means for applying pressure to the skin such as a pneumatic actuator, a hydraulic actuator,
  • Actuation means of the adhesively applied stimulating device may be applied over a small region of the applied area of the subject, such that the adhesive interface provides the biasing force necessary to counter the actuation of the actuation means against the skin of the subject.
  • Adhesively applied stimulating devices may be provided as two components - a disposable body interface and a reusable component.
  • the disposable body interface may be applied so as to conform to the desired anatomy of the subject, and wrap around the body such that the reusable component may interface with the disposable component in a region that is open and free from a natural interface between the subject and another surface.
  • An adhesively applied stimulating device may also be a single component, rather than a two component or other multi-component arrangement.
  • Such a device implemented as a single component may include an adhesive interface to the subject including two or more electrodes that are applied to the subject.
  • Adhesively applied stimulating devices embodied as a single component provide potential advantages such as easier application to the body of the subject, but may come at a disadvantage with regards to one or more of breathability, conformity, access to challenging interfaces, etc. relative to two component or multicomponent arrangements.
  • a non-contacting stimulating device may be, for example an audio and/or visual system, a heating or cooling system, etc.
  • Smart speakers and smart televisions or other displays are examples of audio and/or visual non-contacting stimulation devices.
  • a smart speaker for example, may be used to provide audible stimulus to the subject in the form of an alert, a suggestion, a command, music, other sounds, etc.
  • Other examples of non-contacting stimulating devices include means for controlling temperature such as fans, air conditioners, heaters, etc.
  • One or more stimulating devices may also be incorporated in other systems, such as stimulating devices integrated into a bed, chair, operating table, exercise equipment, etc. that a subject interfaces with.
  • a bed for example, may include one or more pneumatic actuators, vibration actuators, shakers, or the like to provide a stimulus to the subject in response to a command, feedback signal or control signal generated based on measurement of one or more physiologic parameters of the subject utilizing one or more sensing devices.
  • Non-contacting devices may be used to obtain movement information, audible information, skin blood flow changes (e.g., such as by monitoring subtle skin tone changes which correlate with heart rate), respiration (e.g., audible sounds and movement related to respiration), and the like.
  • Such noncontacting devices may be used in place of or to supplement an on-body system for the monitoring of certain conditions, for applying stimulus, etc.
  • Information captured by noncontacting devices may, on its own or in combination with information gathered from sensing devices on the body, be used to direct the application of stimulus to the subject, via one or more stimulating devices on the body and/or via one or more non-contacting stimulating devices.
  • aspects of monitoring the subject utilizing sensing devices in the modular physiologic monitoring system may utilize sensing devices that are affixed to or embodied within one or more contact surfaces, such as surfaces on a piece of furniture on which a subject is positioned (e.g., the surface of a bed, a recliner, a car seat, etc.).
  • the surface may be equipped with one or more sensors to monitor the movement, respiration, HR, etc. of the subject.
  • Stimulating devices may take the form of audio, visual or audiovisual systems or devices in the sleep space of the subject.
  • stimulating devices include smart speakers.
  • Such stimulating devices provide a means for instruction a subject to alter the sleep state thereof.
  • the input or stimulus may take the form of a message, suggestion, command, audible alert, musical input, change in musical input, a visual alert, one or more lights, a combination of light and sound, etc.
  • non-contacting stimulating devices include systems such as Amazon Echo®, Google Home®, Apple Home Pod®, and the like.
  • FIGS. 2A-2C show a modular physiologic monitoring system 200.
  • the modular physiologic monitoring system 200 includes a sensing device 210 and a stimulating device 220 attached to a subject 201 that are in wireless communication 225 with a host device 230.
  • the host device 230 includes a processor, a memory and a network interface.
  • the processor may comprise a microprocessor, a microcontroller, an applicationspecific integrated circuit (ASIC), a field-programmable gate array (FPGA) or other type of processing circuitry, as well as portions or combinations of such circuitry elements.
  • ASIC applicationspecific integrated circuit
  • FPGA field-programmable gate array
  • the memory may comprise random access memory (RAM), read-only memory (ROM) or other types of memory, in any combination.
  • RAM random access memory
  • ROM read-only memory
  • the memory and other memories disclosed herein may be viewed as examples of what are more generally referred to as “processor-readable storage media” storing executable computer program code or other types of software programs.
  • Articles of manufacture comprising such processor-readable storage media are considered embodiments of the invention.
  • a given such article of manufacture may comprise, for example, a storage device such as a storage disk, a storage array or an integrated circuit containing memory.
  • the processor may load the computer program code from the memory and execute the code to provide the functionalities of the host device 230.
  • the network interface provides circuitry enabling wireless communication between the host device 230, the sensing device 210 and the stimulating device 220.
  • FIG. 2A illustrates a modular physiologic monitoring system 200 that includes only a single instance of the sensing device 210 and the stimulating device 220 for clarity. It is to be appreciated, however, that modular physiologic monitoring system 200 may include multiple sensing devices and/or multiple stimulating devices.
  • FIG. 2A illustrates a modular physiologic monitoring system 200 in which the sensing device 210 and the stimulating device 220 are attached to the subject 201, embodiments are not limited to such arrangements.
  • one or more sensing and/or stimulating devices may be part of contacting surfaces or non-contacting devices.
  • the placement of sensing device 210 and stimulating device 220 on the subject 201 may vary as described above.
  • the host device 230 may be worn by the subject 201, such as being incorporated into a smartwatch or other wearable computing device.
  • the functionality provided by host device 230 may also be provided, in some embodiments, by one or more of the sensing device 210 and the stimulating device 220.
  • the functionality of the host device 230 may be provided at least in part using cloud computing resources.
  • FIG. 2B shows a schematic diagram of aspects of the sensing device 210 in modular physiologic monitoring system 200.
  • the sensing device 210 includes one or more of a processor, a memory device, a controller, a power supply, a power management and/or energy harvesting circuit, one or more peripherals, a clock, an antenna, a radio, a signal conditioning circuit, optical source(s), optical detector(s), a sensor communication circuit, vital sign sensor(s), and secondary sensor(s).
  • the sensing device 210 is configured for wireless communication 225 with the stimulating device 220 and host device 230.
  • FIG. 2C shows a schematic diagram of aspects of the stimulating device 220 in modular physiologic monitoring system 200.
  • the stimulating device 220 includes one or more of a processor, a memory device, a controller, a power supply, a power management and/or energy harvesting circuit, one or more peripherals, a clock, an antenna, a radio, a signal conditioning circuit, a driver, a stimulator, vital sign sensor(s), a sensor communication circuit, and secondary sensor(s).
  • the stimulating device 220 is configured for wireless communication 225 with the sensing device 210 and host device 230.
  • Communication of data from the sensing devices and/or stimulating devices may be performed via a local personal communication device (PCD).
  • PCD personal communication device
  • Such communication in some embodiments takes place in two parts: (1) local communication between a patch and/or patch-module pair (e.g., via a hub or module of a patchmodule pair) and the PCD; and (2) remote communication from the PCD to a back-end server, which may be part of a cloud computing platform and implemented using one or more virtual machines (VMs) and/or software containers.
  • the PCD and back-end server may collectively provide functionality of the host device as described elsewhere herein.
  • FIGS. 3A-3E show a wearable sensor system 300 configured for monitoring physiologic and location data for a plurality of users, and for analyzing such data for use in health monitoring.
  • the wearable sensor system 300 can thus be used for managing outbreaks of a disease, including outbreaks associated with epidemics and global pandemics.
  • the wearable sensor system 300 provides the capability for assessing the condition of the human body of a plurality of users.
  • the wearable sensor system 300 includes a wearable device 302 that is affixed to user 336. Data collected from the user 336 via the wearable device 302 is communicated using a wireless gateway 340 to an artificial intelligence (Al) wearable device network 348 over or via network 384.
  • Al artificial intelligence
  • the network 384 may comprise a physical connection (wired or wireless), the Internet, a cloud communication network, etc.
  • wireless communication networks that may be utilized include networks that utilize Visible Light Communication (VLC), Worldwide Interoperability for Microwave Access (WiMAX), Long Term Evolution (LTE), Wireless Local Area Network (WLAN), Infrared (IR) communication, Public Switched Telephone Network (PSTN), Radio waves, and other communication techniques known in the art.
  • VLC Visible Light Communication
  • WiMAX Worldwide Interoperability for Microwave Access
  • LTE Long Term Evolution
  • WLAN Wireless Local Area Network
  • IR Infrared
  • PSTN Public Switched Telephone Network
  • Radio waves and other communication techniques known in the art.
  • Also coupled to the network 384 is a crowd of users 338 and a verification entity 386 coupled to a set of third-party networks 368.
  • Detailed views of the wearable device 302, wireless gateway 340, Al wearable device network 348 and third-party networks 368 are shown in FIGS. 3B
  • the wearable device 302 is implemented using one or more patch-module pairs as described above with respect to FIGS. 1 and 2A-2C.
  • the patch-module pairs described above with respect to FIGS. 1 and 2A-2C are just one example of wearable technology that may be used to provide the wearable device 302.
  • the wearable device 302 comprises a multi-hub patch (e.g., a patch interface designed for interconnection with multiple hubs/modules at different regions thereof, where different hubs/modules process data from different subsets of a plurality of electrodes or other sensors on the patch interface), or combinations of one or more multi-hub patches and one or more patch-module pairs.
  • wearable technology may be used to provide the wearable device 302 in other embodiments, including but not limited to wearables, fashion technology, tech togs and other types of fashion electronics that include “smart” electronic devices (e.g., electronic devices with micro-controllers) that can be incorporated into clothing or worn on the body as implants or accessories.
  • Wearable devices such as activity trackers are examples of Internet of Things (loT) devices, and such “things” include electronics, software, sensors and connectivity units that are effectors enabling objects to exchange data (including data quality) through the Internet with a manufacturer, operator and/or other connected devices without requiring human intervention.
  • Wearable technology has a variety of applications, which grows as the field itself expands. Wearable technology appears prominently in consumer electronics with the popularization of smartwatches and activity trackers. Apart from commercial uses, wearable technology is being incorporated into navigation systems, advanced textiles, and health care.
  • the wearable device 302 is capable of detecting and collecting medical data (e.g., body temperature, respiration, heart rate, etc.) from the wearer (e.g., user 336).
  • the wearable device 302 can remotely collect and transmit real-time physiological data to health care providers and other caretakers responsible for ensuring their communities stay healthy.
  • the wearable sensor system 300 in some embodiments, is user-friendly, hypoallergenic, unobtrusive, and cost-effective. In service of enabling remote evaluation of individual health indicators, the wearable sensor system 300 is configured to transmit data directly into existing health informatics and health care management systems from the comfort of patients’ homes.
  • the wearable device 302 is designed to monitor the state of a subject (e.g., the cardiopulmonary state of user 336) over time in home or in clinical settings. Onboard sensors of the wearable device 302 can quantitatively detect and track severity of a variety of disease symptoms including fever, coughing, sneezing, vomiting, infirmity, tremor, and dizziness, as well as signs of decreased physical performance and changes in respiratory rate/depth.
  • the wearable device 302 may also have the capability to monitor blood oxygenation.
  • the wearable device 302 collects physiologic monitoring data from the subject user 336 utilizing a combination of a disposable sampling unit 312 and at least one reusable sensing unit 314 (as illustrated in FIG. 3B).
  • the patch-module pairs described above with respect to FIGS. 1 and 2A-2C are an example implementation of the disposable sampling unit 312 and reusable sensing unit 314.
  • the disposable sampling unit 312 may be formed from a softer-than-skin patch.
  • the wearable device 302, formed from the combination of the disposable sampling unit 312 and reusable sensing unit 314, is illustratively robust enough for military use, yet extremely thin and lightweight.
  • the disposable sampling unit 312 and reusable sensing unit 314 may collectively weigh less than 0.1 ounce, about the same as a U.S. penny.
  • the wearable device 302 may be adapted for placement almost anywhere on the body of the user 336, such as the various placement sites shown in FIG. 1 and described above.
  • the wearable device 302 may include a number of other components as illustrated in FIG. 3B.
  • Such components include a power source 304, a communications unit 306, a processor 308, a memory 310, a GPS unit 330, an ultra-wideband (UWB) communication unit 332, and a base software module 334.
  • the power source or component 304 of the wearable device 302 includes one or more modules with each module including a power source (e.g., a battery, a rechargeable battery, an energy harvesting transducer, a microcircuit, an energy reservoir, a thermal gradient harvesting transducer, a kinetic energy harvesting transducer, a radio frequency energy harvesting transducer, a fuel cell, a biofuel cell, combinations thereof, etc.).
  • a power source e.g., a battery, a rechargeable battery, an energy harvesting transducer, a microcircuit, an energy reservoir, a thermal gradient harvesting transducer, a kinetic energy harvesting transducer, a radio frequency energy harvesting transducer, a fuel cell, a biofuel cell, combinations thereof, etc.
  • the communications unit 306 of the wearable device 302 may be embodied as communication circuitry, or any communication hardware that is capable of transmitting an analog or digital signal over one or more wired or wireless interfaces.
  • the communications unit 306 includes transceivers or other hardware for communications protocols, such as Near Field Communication (NFC), WiFi, Bluetooth, infrared (IR), modem, cellular, ZigBee, a Body Area Network (BAN), and other types of wireless communications.
  • the communications unit 306 may also or alternatively include wired communication hardware, such as one or more universal serial bus (USB) interfaces.
  • the processor 308 of the wearable device 302 is configured to decode and execute any instructions received from one or more other electronic devices and/or servers.
  • the processor 308 may include any combination of one or more general-purpose processors (e.g., Intel® or Advanced Micro Devices (AMD)® microprocessors), one or more special-purpose processors (e.g., digital signal processors or Xilink® system on chip (SOC) field programmable gate array (FPGA) processors, application-specific integrated circuits (ASICs), etc.), etc.
  • the processor 308 is configured in some embodiments to execute one or more computer-readable program instructions, such as program instructions to carry out any of the functions described herein including but not limited to those of the base software module 334 described below.
  • the processor 308 is illustratively coupled to the memory 310, with the memory 310 storing such computer-readable program instructions.
  • the memory 310 may include, but is not limited to, fixed hard disk drives, magnetic tape, floppy diskettes, optical disks, compact disc read-only memories (CD-ROMs), magnetooptical disks, semiconductor memories such as read-only memory (ROM), random-access memory (RAM), programmable ROM (PROM), erasable PROM (EPROM), electrically erasable PROM (EEPROM), flash memory, magnetic or optical cards, or other type of media/machine-readable medium suitable for storing electronic instructions.
  • the memory 310 may comprise modules implemented as one or more programs.
  • a non- transitory processor-readable storage medium has stored therein program code of one or more software programs, wherein the program code when executed by at least one processing device (e.g., the processor 308) causes said at least one processing device to perform one or more aspects of the methods, algorithms and process flows described herein.
  • the processor 308 and memory 310 are an example of a processing device or controller.
  • the controller may comprise a central processing unit (CPU) for carrying out instructions of one or more computer programs for performing arithmetic, logic, control and input/output (I/O) operations specified by the instructions (e.g., as specified by the base software module 334 as described in further detail below).
  • Such computer programs may be stored in the memory 310.
  • the memory 310 provides electronic circuitry configured to temporarily store data that is utilized by the processor 308. In some embodiments, the memory 310 further provides persistent storage for storing data utilized by the processor 308.
  • components of the wearable sensor system 300 may also include one or more processors coupled to one or more memories providing processing devices implementing the functionality of such components.
  • the wearable device 302 illustratively includes the disposable sampling unit 312 which may be embodied as a physical interface to the skin of the user 336. Patches, including multi-hub patches, as described elsewhere herein are examples of a disposable sampling unit 312. Such patches are adapted for attachment to a human or animal body (e.g., attachable to the skin thereof, reversibly attachable, adhesively attachable, with a disposable interface that couples to a reusable module, etc.).
  • the disposable sampling unit 312 is part of a system that is capable of modular design, such that various wearable devices or portions thereof (e.g., reusable sensing unit 314) are compatible with various disposable sampling units with differing capabilities.
  • the patch or more generally the disposable sampling unit 312 allows sterile contact between the user 336 and other portions of the wearable device 302, such as the reusable sensing unit 314.
  • the other portions of the wearable device 302 e.g., which may be embodied as a module as described above with respect to FIGS. 1 and 2A-2C
  • the patch or other disposable sampling unit 312 is suitable for wearing over a duration of time in which the user 336 is undergoing physiological monitoring (e.g., for symptoms of a disease associated with a global pandemic).
  • the patch or disposable sampling unit 312 may be disposed of after the monitoring duration has ended (e.g., in association with an incubation period of the disease associated with the global pandemic).
  • FIG. 3B shows an example where there is just a single reusable sensing unit 314 (e.g., a single hub/module) for clarity of illustration, it should be appreciated that multiple instances of the reusable sensing unit may be utilized if the disposable sampling unit 312 is embodied as a multi-hub patch.
  • the reusable sensing unit 314 includes various sensors, such as one or more temperature sensors 316, one or more heart rate sensors 318, one or more respiration sensors 320, one or more pulse oximetry sensors 322, one or more accelerometer sensors 324, one or more audio sensors 326, and one or more other sensors 328.
  • One or more of the sensors 316-328 may be embodied as electric features, capacitive elements, resistive elements, touch sensitive components, analyte sensing elements, printed electrochemical sensors, light sensitive sensing elements, electrodes (e.g., including but not limited to needle electrodes, ionically conducting electrodes, reference electrodes, etc.), electrical traces and/or interconnects, stretch sensing elements, contact interfaces, conduits, microfluidic channels, antennas, stretch resistant features, stretch vulnerable features (e.g., a feature that changes properties reversibly or irreversibly with stretch), strain sensing elements, photo-emitters, photodiodes, biasing features, bumps, touch sensors, pressure sensing elements, interfacial pressure sensing elements, piezoelectric elements, piezoresistive elements, chemical sensing elements, electrochemical cells, electrochemical sensors, redox reactive sensing electrodes, light sensitive structures, moisture sensitive structures, pressure sensitive structures, magnetic structures, bioadhesives, antennas, transistors, integrated circuits, trans
  • one or more of the sensors 316-328 have a controlled mass transfer property, such as a controlled moisture vapor conductivity so as to allow for a differential heat flux measurement through the patch or other disposable sampling unit 312. Such properties of one or more of the sensors 316-328 may be used in conjunction with the one or more temperature sensors 316 to obtain core temperature measurements of the user 336. It should be noted that one or more of the sensors 316-328 or the reusable sensing unit 314 generally may be associated with signal conditioning circuitry used in obtaining core temperature or other measurements of physiologic parameters of the user 336.
  • Core temperature measurements may, in some embodiments, be based at least in part on correlation parameters extracted from sensors of multiple wearable devices, or from sensors of the same wearable device that interface with different portions of the user 336.
  • the correlation parameters may be based on thermal gradients computed as comparisons of multiple sensor readings (e.g., from a first subset of sensors oriented to make thermal contact with the user 336 and from a second subset of sensors oriented to make thermal contact with ambient surroundings, etc.). Core temperature readings may thus be estimated from the thermal gradients.
  • Changes in core temperature readings from multiple sensor readings over some designated period of time are analyzed to generate correlation parameters that relate changes in core temperature readings from the multiple sensors.
  • this analysis includes determining which of the multiple sensors has a lowest thermal gradient and weighting the correlation parameters to the sensor or device having the lowest thermal gradient.
  • the temperature sensors 316 comprise one or more digital infrared temperature sensors (e.g., Texas Instruments TMP006 sensors).
  • the heart rate sensors 318 are configured to sense physiological parameters of the user 336, such as conditions of the cardiovascular system of the user 336 (e.g., heart rate, blood pressure, heart rate variability, etc.).
  • the physiological parameters comprise one or more bioimpedance measurements
  • correlation parameters may be generated by extracting local measures of water content from bioimpedance signals recorded from multiple sensors potentially at different sites on the body of the user 336.
  • the local measures of water content recorded by different devices or sensors may be recorded during at least a portion of a transitionary period as described above to generate correlation parameters for application to bioimpedance signals recorded by the different sensors to offset at least a portion of identified differences therebetween.
  • the correlated changes in the local measures of water content may be associated with a series of postural changes by the user 336.
  • the respiration sensors 320 are configured to monitor the condition of respiration, rate of respiration, depth of respiration, and other aspects of the respiration of the user 336.
  • the respiration sensors 320 may obtain such physiological parameters by placing the wearable device 302 (e.g., a patch-module pair thereof) on the abdomen of the user 336 for monitoring movement or breathing, below the rib cage for monitoring respiration (generally on the right side of the body to substantially reduce EKG influences on the measurements), such placement enabling the respiration sensors 320 to provide rich data for respiration health, which may be advantageous in detection of certain infectious diseases that affect the respiratory tract of victims, such as, for example, coronavirus/COVID-19.
  • the pulse oximetry sensors 322 are configured to determine oxygen saturation (SpO2) using a pulse oximeter to measure the oxygen level or oxygen saturation of the blood of the user 336.
  • the accelerometer sensors 324 are configured to measure acceleration of the user 336.
  • Single and multi -axis models of accelerometers may be used to detect the magnitude and direction of the proper acceleration as a vector quantity, and can be used to sense orientation (e.g., based on the direction of weight changes), coordinate acceleration, vibration, shock, and falling in a resistive medium (e.g., a case where the proper acceleration changes, since it starts at zero then increases).
  • the accelerometer sensors 324 may be embodied as micromachined microelectromechanical systems (MEMS) accelerometers present in portable electronic devices such as the wearable device 302.
  • MEMS micromachined microelectromechanical systems
  • the accelerometer sensors 324 may also be used for sensing muscle contraction for various activities, such as running and other erect sports.
  • the accelerometer sensors 324 may detect such activity by measuring the body or extremity center of mass of the user 336. In some cases, the body center of mass may yield the best timing for the injection of fluid. Embodiments, however, are not limited solely to use with measuring the body center of mass.
  • the audio sensors 326 are configured to convert sound into electrical signals, and may be embodied as one or more microphones or piezoelectric sensors that use the piezoelectric effect to measure changes in pressure, acceleration, temperature, strain, or force by converting them to an electrical charge.
  • the audio sensors 326 may include ultrasonic transducer receivers capable of converting ultrasound into electrical signals.
  • the sensors 316-326 described above are presented by way of example only, and that the reusable sensing unit 314 may utilize various other types of sensors 328 as described elsewhere herein.
  • the other sensors 328 include one or more of motion sensors, humidity sensors, cameras, radiofrequency receivers, thermal imagers, radar devices, lidar devices, ultrasound devices, speakers, etc.
  • the GPS unit 330 is a component of the wearable device 302 configured to detect global position using GPS, a satellite-based radio navigation system owned by the U.S. government and operated by the U.S. Space Force.
  • GPS is one type of global navigation satellite system (GNSS) that provides geolocation and time information to a GPS receiver anywhere on or near the Earth where there is an unobstructed line of sight to four or more GPS satellites.
  • GNSS global navigation satellite system
  • the UWB communication unit 332 is a component of the wearable device 302 configured to detect UWB radiofrequencies.
  • UWB is a short-range, wireless communication protocol similar to Bluetooth or WiFi, which uses radio waves at a very high frequency.
  • UWB also uses a wide spectrum of several gigahertz (GHz).
  • GHz gigahertz
  • the base software module 334 is configured to execute various functionality of the wearable device 302.
  • Software programs or computer instructions for the base software module 334 when executed cause the processor 308 to poll the reusable sensing unit 314 for sensor data from any combination of the sensors 316-328, to determine localization data using the GPS unit 330 and UWB communication unit 332, and to send the sensor data and the localization data to the wireless gateway 340 via the communications unit 306.
  • the software programs or computer instructions from the base software module 334 may also cause the processor 308 to store the sensor data and localization data in the memory 310.
  • the software programs or computer instructions of the base software module 334 may further cause the processor 308 to provide various other functionality such as testing and/or calibrating the reusable sensing unit 314 or sensors 316-328 thereof, testing the power source 304, physiologic monitoring data analysis and generation of visualizations of physiologic monitoring data, etc.
  • the user 336 may be a human or animal to which the wearable device 302 is attached.
  • the user 336 may be a patient that is being tested for one or more diseases associated with a global pandemic. In some embodiments, the user 336 is tested for symptoms of at least one disease while the user 336 is in isolation.
  • the user 336 may also be the subject of a study (e.g., a fitness test, training for an athletic event, evaluating performance during an athletic event, training for one or more military or other tactical scenarios or missions, evaluating performance during a military or other tactical scenario or mission, etc.).
  • Sensor data and localization data collected by the wearable device 302 may be provided to Al wearable device network 348 for analysis, with portions of such analysis being provided to one or more of the third-party networks 368 for various purposes such as monitoring, diagnosing, and treating patients who may have been exposed to viral pathogens, monitoring and evaluating performance or status of users performing different activities (e.g., athletic training or performances, military or other tactical scenarios or missions, etc.).
  • Communication of the sensor and localization data from the wearable device 302 to the Al wearable device network 348 may take place via a wireless gateway 340, with the communication between the wireless gateway 340 and the Al wearable device network 348 taking place over one or more networks 384.
  • the user 336 may configure the wireless gateway 340 to include a user profile 344.
  • the user profile 344 may include various health and physiological data about the user 336 that may not be obtained by sensors 316-328 of the wearable device 302.
  • the user profile may include information such as a name and biological sex (e.g., first, last and middle name), age (e.g., in years), weight (e.g., in pounds, kilograms, etc.), and height (e.g., in feet or inches, in meters, etc.).
  • the user profile may also include known diseases and disorders (e.g., asthma, allergies, current medications, family medical history, other medical data, etc.).
  • PHI Protected Health Information
  • HIPAA American Health Insurance Portability and Accountability Act
  • PHI includes individually identifiable health information that relates to one or more of: the past, present, or future physical or mental health or condition of an individual; provision of health care to the individual by a covered entity (e.g., a hospital or doctor); the past, present, or future payment for the provision of health care to the individual; telephone numbers, fax numbers, email addresses, Social Security numbers, medical record numbers, health plan beneficiary numbers, license plate numbers, uniform resource locators (URLs), full-face photographic images or any other unique identifying numbers, characteristics, codes, or combination thereof that allows identification of an individual.
  • a covered entity e.g., a hospital or doctor
  • URLs uniform resource locators
  • the user profile may further include an emergency contact (e.g., name, phone number, address, etc.), next of kin (e.g., name, phone number, address, etc.), preferred hospital (e.g., name, phone number, address, etc.) and primary care physician (PCP) of the user 336 (e.g., name, phone number, place of business, etc.).
  • the user profile may further include local caregiver information (e.g., name, phone number, address, etc.) and preferred first responder network information (e.g., name, phone number, address, etc.).
  • the local caregiver may be, for example, a nursing agency, a private caregiver such as a family member, a nursing home, or other local caregivers such as physical therapists, chiropractors, pharmacists, pediatricians, acupuncture specialists, massage therapists, etc.
  • the local caregiver is associated with one or more telemedicine networks.
  • the preferred first responder network may be, for example, a local hospital and/or a local ambulatory rescue agency.
  • the preferred first responder network may be an interface with an emergency calling network (e.g., 911).
  • the wireless gateway 340 sends the sensor data and localization data obtained from the user 336 by the wearable device 302 utilizing communications unit 346, which may comprise any type of transceiver for coupling the wireless gateway 340 to the network 384.
  • the communications unit 346 of the wireless gateway 340 may be embodied as communication circuitry or any communication hardware capable of transmitting an analog or digital signal over wired or wireless network interfaces. Such network interfaces may support not only communication with the Al wearable device network 348 over network 384, but also communications between the wearable device 302 and the wireless gateway 340. Any combination of network types may be utilized, including but not limited to NFC, WiFi, Bluetooth, IR, modem, cellular, ZigBee, BAN, etc.
  • the wireless gateway 340 may be, for example, a smartphone, a tablet, a laptop or desktop computer, an Internet-connected modem, a wireless router or standalone wireless hub device connected to the Internet, etc.
  • the wireless gateway 340 may itself comprise or be incorporated into one or more wearable devices (e.g., a smartwatch, an activity tracker, etc.). In some cases, the wireless gateway 340 may be part of the wearable device 302, or vice versa.
  • the wireless gateway 340 is illustratively a smart device that is owned or controlled by the user 336, such as a smartphone, and allows rapid onboarding of wearable devices such as wearable device 302 to the Al wearable device network 348.
  • the wireless gateway 340 includes a wearable device module 342 that provides software programs or computer instructions for providing functionality of the wireless gateway 340.
  • the wireless gateway 340 is assumed to comprise at least one processing device or controller including a processor coupled to a memory for executing the functionality of the wearable device module 342.
  • Such functionality includes receiving the sensor data and the localization data from the wearable device 302 via the communications unit 346, and possibly performing a preliminary analysis of the sensor data and the localization data. Such analysis may be based at least in part on information stored in the user profile 344. Based on such analysis, the wearable device module 342 may determine whether any immediate notifications should be provided to the user 336.
  • Such notifications may comprise, for example, indications of symptoms associated with at least one disease state or medical condition.
  • the wearable device 302 functions as a pass-through entity and does not perform such preliminary analysis.
  • the wireless gateway 340 may provide the sensor data and the localization data received from the wearable device 302, along with the associated user profile 344, to the Al wearable device network 348 over network 384 as a pass-through entity.
  • the wearable device module 342 of the wireless gateway 340 may receive any combination of diagnostic information, world health information, sensor data analysis, localization analysis, analysis created from a fusion of data from a plurality of sensors, etc. from the Al wearable device network 348. At least a portion of the received information is based on analysis of the sensor data, the localization data and the user profile 344 or information derived therefrom previously provided by the wireless gateway 340 to the Al wearable device network 348. At least a portion of the received information is used to generate notifications or other output via a graphical user interface (GUI) of the wireless gateway 340, the wearable device 302 or another type of local or remote indicator device.
  • GUI graphical user interface
  • the wearable device module 342 may provide functionality for determining notification settings associated with the user 336, and to execute or deliver notifications in accordance with the determined notification settings.
  • the notification settings may specify the types of indicator devices that are part of or otherwise accessible to the wearable device 302 for delivering notifications to the user 336 (or to a doctor, nurse, physical therapist, medical assistant, caregiver, coach or medical trainer, leader of a troop or other unit, etc. associated with the user 336).
  • the indicator devices in some embodiments may be configured to deliver visual or audible alarms. In other embodiments, the indicator devices may be configured to provide stimulus or feedback via stimulating devices as described elsewhere herein.
  • Such stimulus or feedback may include physical stimulus (e.g., electrical, thermal, vibrational, pressure, stroking, a combination thereof, or the like), optical stimulus, acoustic stimulus, etc.
  • notifications may be delivered to remote terminals or devices other than the wearable device 302 associated with user 336.
  • notifications may be delivered to one or more devices associated with a doctor, nurse, physical therapist, medical assistant, caregiver, etc. associated with the user 336.
  • the notification delivery method may also or alternatively comprise a visual or audible read-out or alert from a “local” device that is in communication with the wearable device 302.
  • the local device may comprise, for example, a mobile computing device such as a smartphone, tablet, laptop etc., or another computing device, that is associated with the user 336.
  • the wearable device 302 is one example of a local device.
  • a local device may also include devices connected to the wearable device 302 via a BAN or other type of local or short- range wireless network (e.g., a Bluetooth network connection).
  • the notification delivery method may further or alternatively comprise a visual or audible read-out or alert from a “remote” device that is in communication with the wearable device 302 or the wireless gateway 340 via network 384.
  • the remote device may be a mobile computing device such as a smartphone, tablet, laptop, etc., or another computing device (e.g., a telemetry center or unit within a hospital or other facility), that is associated with a doctor, nurse, physical therapist, medical assistant, caregiver, etc. monitoring the user 336.
  • the term “remote” in this context does not necessarily indicate any particular physical distance from the user 336.
  • a remote device to which notifications are delivered may be in the same room as the user 336.
  • remote in this context is instead used to distinguish from “local” devices (e.g., in that a “local” device in some embodiments is assumed to be owned by, under the control of, or otherwise associated with the user 336, while a “remote” device is assumed to be owned by, under the control of, or otherwise associated with a user or users other than the user 336 such as a doctor, nurse, physical therapist, medical assistance, caregiver, etc.).
  • the indicator devices may include various types of devices for delivering notifications to the user 336 (or to a doctor, nurse, physical therapist, medical assistant, caregiver, etc. associated with the user 336).
  • one or more of the indicator devices comprise one or more light emitting diodes (LEDs), a liquid crystal display (LCD), a buzzer, a speaker, a bell, etc., for delivering one or more visible or audible notifications.
  • the indicator devices may include any type of stimulating device as described herein which may be used to deliver notifications to the user 336 (or to a doctor, nurse, physical therapist, medical assistant, caregiver, etc. associated with the user 336).
  • FIG. 3A also shows the crowd of users 338, each of which is assumed to provide sensor data and localization data obtained by a plurality of wearable devices to the Al wearable device network 348, possibly via respective wireless gateways.
  • the wearable devices and wireless gateways for the crowd of users 338 may be configured in a manner similar to that described herein with respect to the wearable device 302 and the wireless gateway 340 associated with the user 336.
  • the Al wearable device network 348 is configured to receive data (e.g., sensor data, localization data, user profiles, preliminary analysis of sensor and localization data, etc.) from the wireless gateway 340 and the crowd of users 338.
  • the Al wearable device network 348 analyzes the received data using various software modules implementing Al algorithms for determining disease states, types of symptoms, risk of infection, contact between users, condition of physiological parameters, etc. As shown in FIG.
  • such modules include a third- party application programming interface (API) module 350, a pandemic response module 352, a vital monitoring module 354, a location tracking module 356, an automated contact tracing module 358, a disease progression module 360, an in-home module 362, an essential workforce module 364, a first responder module 388, a local caregiver module 390, and a physiologic signal mapping module 392.
  • the Al wearable device network 348 also includes a database 366 configured to store the received data, results of analysis on the received data, data obtained from third-party networks 368, etc.
  • the Al wearable device network 348 is implemented as an application or applications running on one or more physical or virtual computing resources.
  • Physical computing resources include, but are not limited to, smartphones, laptops, tablets, desktops, wearable computing devices, servers, etc.
  • Virtual computing resources include, but are not limited to, VMs, software containers, etc.
  • the physical and/or virtual computing resources implementing the Al wearable device network 348, or portions thereof, may be part of a cloud computing platform.
  • a cloud computing platform includes one or more clouds providing a scalable network of computing resources (e.g., including one or more servers and databases).
  • the clouds of the cloud computing platform implementing the Al wearable device network 348 are accessible via the Internet over network 384.
  • the clouds of the cloud computing platform implementing the Al wearable device network 348 may be private clouds where access is restricted (e.g., such as to one or more credentialed medical professionals or other authorized users).
  • the Al wearable device network 348 may be considered as forming part of an emergency health network comprising at least one server and at least one database (e.g., the database 366) storing health data pertaining to a plurality of users (e.g., the user 336 and crowd of users 338).
  • the database 366 provides a data store for information about patient conditions and/or performance during some activity (e.g., information about the user 336 and crowd of users 338), information relating to diseases including epidemics or pandemics, etc. Although shown as being implemented internal to the Al wearable device network 348 in FIG. 3D, it should be appreciated that the database 366 may also be implemented at least in part external to the Al wearable device network 348 (e.g., as a standalone server or storage system). The database 366 may be implemented as part of the same cloud computing platform that implements the Al wearable device network 348.
  • the Al wearable device network 348 may exchange various information with third- party network 368.
  • the third-party network 368 may include any combination of one or more first responder networks 370, one or more essential workforce networks 372, one or more local caregiver networks 374, one or more hospital networks 376, one or more state and local health networks 378, one or more federal health networks 380, one or more world health networks 382, etc.
  • Third-party networks 368 may also include telemedicine networks.
  • one or more of the local caregiver networks 374 may comprise or be associated with one or more telemedicine networks, such that local caregivers of the local caregiver networks 374 may provide care to patients or users via telemedical communications.
  • one or more of the third-party networks 368 may receive data and analysis from the Al wearable device network 348, for various purposes including but not limited to diagnosis, instruction, pandemic monitoring, disaster response, resource allocation, medical triage, any other tracking or intervention of global pandemics and associated logistics, etc.
  • the first responder networks 370 may include any person or team with specialized training who is among the first to arrive and provide assistance at the scene of an emergency, such as an accident, natural disaster, terrorism, etc.
  • First responders include, but are not limited to, paramedics, emergency medical technicians (EMTs), police officers, fire fighters, etc.
  • the essential workforce networks 372 may include networks for employers and employees of essential workforces of any company or government organization that continues operation during times of crises, such as a viral pandemic.
  • Essential workforces include, but are not limited to, police, medical staff, grocery workers, pharmacy workers, other health and safety service workers, etc.
  • the local caregiver networks 374 may include a network of local clinics, family doctors, pediatricians, in-home nurses, nursing home staff, and other local caregivers.
  • the hospital networks 376 allow transfer of data between hospitals and the Al wearable device network 348.
  • the exchange of information between the Al wearable device network 348 and third- party networks 368 may involve use of a verification entity 386, which ensures data security in accordance with applicable rules and regulations (e.g., HIPAA).
  • the Al wearable device network 348 utilizes the third-party API module 350 to perform such verification of the third- party networks 368 utilizing the verification entity 386, before providing any data or analysis thereof related to the user 336 or crowd of users 338 to any of the third-party networks 368.
  • any data or analysis related to the user 336 or crowd of users 338 may be anonymized prior to being sent to one or more of the third-party networks 368, such as in accordance with privacy settings in user profiles (e.g., user profile 344 associated with the user 336, user profiles associated with respective users in the crowd of users 338, etc.).
  • the pandemic response module 352 is configured to execute processes based on receiving pandemic data from one or more of the third-party networks 368 via the third-party API module 350. The pandemic response module 352 may analyze such received information and provide notifications to the user 336 or crowd of users 338 including relevant information about the pandemic.
  • the pandemic response module 352 may further collect and analyze physiological data of the user 336 or crowd of users 338 that may be relevant to the pandemic, and provides instructions to users who may be at risk due to the pandemic. Information about such at-risk users may also be provided to one or more of the third-party networks 368. The pandemic response module 352 may continually update the database 366 with relevant pandemic data including information about at-risk users.
  • the pandemic response module 352, while described herein as processing information related to pandemics, may also be configured to process information related to epidemics and other outbreaks of diseases that do not necessarily reach the level of a pandemic.
  • the pandemic response module 352 may also process information from the user 336 and crowd of users 338 so as to predict that a pandemic, epidemic or other disease outbreak is or is likely to occur. Thus, the functionality of the pandemic response module 352 is not limited solely to use in processing pandemic information.
  • the vital monitoring module 354 may monitor and analyze physiological data of the user 336 and crowd of users 338 to detect and mitigate pandemics, epidemics and other outbreaks or potential outbreaks of diseases. The physiological data may be analyzed to determine if there is evidence of a disease associated with a pandemic (e.g., shortness of breath associated with respiratory illness).
  • the vital monitoring module 354 may also or alternatively monitor and analyze physiological data of the user 336 and crowd of users 338 while performing various activities (e.g., athletic events or training, military or other tactical missions or training thereof, normal or routing daily activity of a subject while exposed to different environmental conditions, etc.).
  • activities e.g., athletic events or training, military or other tactical missions or training thereof, normal or routing daily activity of a subject while exposed to different environmental conditions, etc.
  • the location tracking module 356 is configured to track the location of user 336 and the crowd of users 338, to determine whether any of such users enter or exit regions associated with a pandemic or other outbreak of a disease.
  • the location tracking module 356, may alert users who have entered a geographic location or region associated with increased risk of exposure to an infectious disease (e.g., associated with an epidemic, pandemic or other outbreak).
  • various alerts, notifications and safety instructions are provided to the user 336 and crowd of users 338 based on their location.
  • the threshold for detection of symptoms associated with an infectious disease e.g., associated with an epidemic, pandemic or other outbreak
  • the automated contact tracing module 358 is configured to use the tracked location of the user 336 and crowd of users 338 (e.g., from the location tracking module 356) so as to determine possible contacts between such users, and also to assess risk of infection on a peruser basis.
  • the automated contact tracing module 358 may also automate the delivery of notifications to the user 336 and crowd of users 338 based on potential exposure to other users or geographic regions associated with a pandemic or other outbreak of a disease.
  • the automated contact tracing module 358 may further provide information regarding contacts between the user 336 and crowd of users 338 to one or more of the third-party networks 368 (e.g., indicating compliance with risk mitigation strategies for pandemic response).
  • the disease progression module 360 is configured to analyze physiologic data from the user 336 and crowd of users 338, and to determine whether such physiologic data is indicative of symptoms of a disease. As new physiologic data from the user 336 and crowd of users 338 is received, trends in such data may be used to identify the progression of a pandemic or other outbreak of a disease.
  • the disease progression module 360 may be configured to monitor the progression of specific infectious diseases, such as infectious diseases associated with epidemics, pandemics or other outbreaks, based on any combination of: user indication of a contracted disease; one or more of the third-party networks 368 indicating that users have contracted a disease; the vital monitoring module 354 detecting a user contracting a disease with probability over some designated threshold; etc.
  • the disease progression module 360 is further configured to compare disease progress for different ones of the users 336 and crowd of users 338 with typical disease progress to determine individual user health risk.
  • the in-home module 362 is configured to analyze location data from the user 336 and crowd of users 338, and to determine whether any of such users are in locations with stay-at- home or other types of quarantine, social distancing or other self-isolation orders or recommendations in effect. If so, the in-home module 362 may provide notifications or alerts to such users with instructions for complying with the stay-at-home, quarantine, social distancing or other self-isolation orders or recommendations, for mitigating an infectious disease, for preventing spread of the infectious disease, etc.
  • the in-home module 362 may be further configured to provide in-home monitoring of infected patients that are quarantined or self-isolated at home, providing warnings to such users that leave the home, instructions for mitigating the disease, etc.
  • the in-home module 362 may further provide in-home monitoring data to one or more of the third-party networks 368.
  • the essential workforce module 364 is configured to identify ones of the user 336 and crowd of users 338 that are considered part of an essential workforce or are otherwise considered essential personnel. Once identified, the essential workforce users’ physiologic data may be analyzed to determine risk profiles for such users, and the algorithms implemented by modules 350 through 362 may be modified accordingly. As one example, the functionality of the in-home module 362 may be modified such that alerts or notifications are not sent to essential workforce users when leaving areas associated with stay-at-home, quarantine, social distancing or other self-isolation orders (e.g., those users would not receive alerts or notifications when traveling to or from their associated essential workplaces). Various other examples are possible, as will be described elsewhere herein.
  • the first responder module 388 is configured to receive first responder data from the first responder networks 370 (e.g., data pertaining to, for example, individual users and/or groups of users based on analyzed wearable device data and/or calculated risk scores for the individual users and/or groups of users).
  • the first responder data may include alerts or notifications indicating severity of risk (e.g., high, medium, low) and additional precautions or treatments that a user or group of users may wish to seek out, such as testing or antiviral treatments, hygiene precautions, self-isolation, social distancing or quarantine precautions, etc.
  • the first responder module 388 is also configured to identify users associated with the received first responder data (e.g., based on the users being employees or patients of the first responder networks 370, or some other user related to the first responder networks 370).
  • the first responder module 388 is further configured to deliver notifications to the identified users.
  • Each alert or notification may be customized to a given user, based at least in part on their wearable device data, user profile and other data related to the user and/or the first responder networks 370 related to the user (e.g., to have more or less sensitive thresholds for exhibiting symptoms associated with global health data, based on users associated with the first responder networks 370 which are or should be more or less restricted based on need or risk of exposure depending on the global health data, etc.).
  • the global health data may include instructions for computing the relative risk of a first responder being infected versus being unable to work, as a lack of first responders may increase health risks for patients in their jurisdiction if the medical system becomes understaffed.
  • the first responder module 388 is also configured to model physiological monitoring data for users associated with the first responder networks 370 (e.g., utilizing the vital monitoring module 354, location tracking module 356, automated contact tracing module 358, etc.) against the predicted outcome of such users’ absence from the workforce, and a computed risk of being infected and therefore risking the infection of others to calculate user-specific risk scores (e.g., associated with a user’s likelihood of infection or of infecting other users).
  • user-specific risk scores e.g., associated with a user’s likelihood of infection or of infecting other users.
  • the calculated user-specific risk scores and other data may be stored in the database 366.
  • the data may be stored in association with a specific user, or may be anonymized for user privacy and security such as by utilizing an encryption algorithm selected based on the user’s security settings or security protocols associated with the first responder networks 370 (or other ones of the third-party networks 368).
  • the calculated user-specific risks may be sent to the first responder networks 370.
  • the local caregiver module 390 is also configure to identify users associated with the received local caregiver data (e.g., based on the users being employees or patients of the local caregiver networks 374, or some other user related to the local caregiver networks 374).
  • the local caregiver module 390 is further configured to modify notifications to be delivered to the identified users based on the received local caregiver data (e.g., notification thresholds may be modified to be more or less sensitive thresholds for exhibiting symptoms associated with global health data, users associated with the local caregiver networks 374 may be more or less restricted based on need or risk of exposure depending on the global health data, etc.).
  • the local caregiver module is also configured to model physiological monitoring data for users associated with the local caregiver networks 374 (e.g., utilizing the vital monitoring module 354, location tracking module 356, automated contact tracing module 358, etc.) against the predicted outcome of such users’ absence from the workforce, and a computed risk of being infected and therefore risking the infection of others to calculate userspecific risk scores (e.g., associated with a user’s likelihood of infection or of infecting other users).
  • the calculated user-specific risk scores and other data may be stored in the database 366.
  • the data may be stored in association with a specific user, or may be anonymized for user privacy and security such us by utilizing an encryption algorithm selected based on the user’s security settings or security protocols associated with the local caregiver networks 374 (or other ones of the third-party networks 368).
  • the calculated user-specific risks are sent to the local caregiver networks 374.
  • the physiologic signal mapping module 392 is configured to obtain data collected from the wearable device 302 associated with the user 336 (e.g., via the wireless gateway 340) and to determine a location of the wearable device 302 on the user 336 using spatial modeling data which may be maintained, for example, in the database 366.
  • the physiologic signal mapping module 392 is further configured to convert the signaling collected from the wearable device 302 at the determined locations into signaling which would have been collected at one or more target locations on the user 336.
  • the signaling collected from the wearable device 302 may be converted into a 12-lead equivalent by converting the signaling obtained from the wearable device 302 into signaling which would have been obtained from 12-lead sites on the user 336.
  • an expert e.g., with knowledge of where to correctly place the wearable device 302 on the user 336 at the 12-lead sites
  • it is difficult to place the wearable device 302 on the user 336 in the correct 12-lead sites etc.
  • Various other examples are possible.
  • FIG. 4 illustrates a block diagram of a system 400 for performing EP mapping.
  • the system 400 comprises a processor 402, a display interface 404, a plurality of electrodes 406, a memory 408, a communication device 410, and a network interface 412.
  • the processor 402 may be coupled to the plurality of electrodes 406 and the memory 408 via the network interface 412.
  • the processor 402 may be configured to receive data related to the plurality of electrodes 406 via the network interface 412 either directly from the plurality of electrodes 406, or from the memory 408.
  • the data related to the plurality of electrodes 406 may comprise a voltage and/or current level of each of the plurality of electrodes 406.
  • the processor 402 may be further configured to receive various other information over the network interface 412, either directly from the plurality of electrodes 406, from the memory 408, or from one or more other devices. Such information may include, but is not limited to: information related to stimulation of the plurality of electrodes 406 based on the voltage and/or current levels of the plurality of electrodes 406; information related with working of the plurality of electrodes 406; etc.
  • the processor 402 may also be configured to receive data related to a subject (e.g., to which the electrodes 406 are attached) from the memory 408 or another device.
  • the data related to the subject may comprise heartbeats per second of the subject, a target heart rate range of the subject, a maximum heart rate of the subject, etc.
  • the processor 402 is configured to process the received data for output or display on the display interface 404.
  • the display interface 404 receives data from the processor 402.
  • the display interface 404 may be configured to display voltage and/or current levels of the plurality of electrodes 406.
  • the display interface 404 may also be configured to display the information related with working of the plurality of electrodes 406.
  • the display interface 404 may further be configured to display data related to the subject, including the heartbeats per second of the subject, the target heart rate range of the subject, the maximum heart rate of the subject, etc.
  • the display interface 404 may be further configured to display information related to stimulation of the plurality of electrodes 406 based on the voltage and/or current levels of the plurality of electrodes 406.
  • the plurality of electrodes 406 are connected to the subject using a plurality of wires 414 and a plurality of catheters 416.
  • the plurality of electrodes 406 are configured to send and receive voltages and currents through the plurality of wires 414 and the plurality of catheters 416.
  • the memory 408 comprises a subject health management database 418.
  • the subject health management database 418 may store a record of health parameters related to health of a subject. Further, the subject health management database 418 may be configured to store data related with the body of the subject. The data related with the body of the subject may comprise the heartbeats per second of the subject, the target heart rate range of the subject, the maximum heart rate of the subject, etc.
  • the memory 408 is further configured to receive the data related to the voltage and/or current levels of the plurality of electrodes 406 from the processor 402.
  • the memory 408 may be configured to store in the subject health management database 418 information related with the stimulation of the plurality of electrodes 406 based on the voltage and/or current levels of the plurality of electrodes 406.
  • Various other data related to the plurality of electrodes 406 may be stored in the subject health management database 418.
  • the communication device 410 may facilitate transferring data related to the subject’s health from the subject health management database 418 to the processor 402. In some embodiments, the communication device 410 may also facilitate transferring data related to the subject’s health from the subject health management database 418 to any device used by a doctor or other personnel treating the subject. In order to obtain a ventricular map of the heart of the subject using the system 400, the doctor may have to carry out many procedures quite often that go over several different heart beats. In the system 400 of FIG. 4, the plurality of catheters 416 are inserted into the body of the subject using the plurality of wires 414.
  • the use of the plurality of catheters 416 may facilitate extracting a good amount of data, but has the drawback of making the subject lie on a bed for long hours with little or no movement.
  • the plurality of electrodes 406 are taken off from their respective placements on the body of the subject, and the subject is put in an MRI machine to measure different datasets related to the subject’s health. Another challenge which still remains unresolved is squaring the data to a uniform level.
  • certain conditions that are desirable to detect e.g., arrhythmia
  • use of the system 400 involves complex procedures due to the utilization of the plurality of catheters 416 and associated wires 414.
  • FIG. 5 illustrates a block diagram of a system 500, which is configured to perform EP mapping and MRI simultaneously to assess a subject’s heart activity.
  • the system 500 comprises a display interface 502, a memory 504, a multi-hub patch 506, and a network interface 508.
  • the display interface 502 is configured to display various parameters related to the system 500, as discussed below.
  • the memory 504 comprises an EP mapping database 510 for storing informing related to the EP process performed on the subject.
  • the multi -hub patch 506 comprises a plurality of electrodes 512, a processor 514, a measurement controller 516 including a frequency generator 518 and a row and column decoder 520, a power source 522, a plurality of hubs 524, a cross-point switch 526, and a communication device 528.
  • the system 500 further includes a base module 530 implementing a number of sub-modules including a data collection module 532, a set-up module 534, a stimulation module 536, a monitoring module 538, a lead equivalent module 540 and an on-board test module 542.
  • the base module 530 may be implemented by or utilizing the processor 514 of the multi-hub patch 506, one or more of the plurality of hubs 524, the communication device 528, or an external device or service (e.g., a host device such as the host device 145, 230, the wearable device 302, the wireless gateway 340, the Al wearable device network 348, one or more of the third-party networks 368, another external server or cloud-based computing platform, etc.).
  • an external device or service e.g., a host device such as the host device 145, 230, the wearable device 302, the wireless gateway 340, the Al wearable device network 348, one or more of the third-party networks 368, another external server or cloud-based computing platform, etc.
  • the display interface 502 may include, but is not limited to, a video monitoring display, a smartphone, a tablet, etc.
  • the display interface 502 may be coupled with the multihub patch 506 and other system elements (e.g., processor 514, base module 530, etc.) either directly or via network interface 508 to receive and display data related with the multi-hub patch 506 and the plurality of electrodes 512.
  • the display interface 502 may be configured to display the information related to working of the plurality of electrodes 512, such as displaying information related to the voltage and/or current levels of the plurality of electrodes 512.
  • the display interface 502 may also be configured to display information related to the subject, including but not limited to heartbeats per second of the subject, the target heart rate range of the subject, the maximum heart rate of the subject, etc., as well as data associated with implanted heart electrodes. In some embodiments, the display interface 502 displays the maximum heart rate, the heart rate status and an on/off status of the plurality of electrodes 512. It should be noted that the plurality of electrodes 512 may provide information related to the body of the subject, and that such data may be retrieved directly from the plurality of electrodes 512 or may be accessed from the memory 504.
  • the memory 504 is coupled with the display interface 502, the multi-hub patch 506 (e.g., the processor 514 thereof) and the base module 530 via the network interface 508, and is configured to store data related to the heart activity of the subject and heart electrode information for the plurality of electrodes 512 and other data associated with the multi-hub patch 506.
  • the data related with the heart activity of the subject may include, but is not limited to, heartbeats per second, a target heart range, a maximum heart rate, positions of respective ones of the plurality of electrodes 512 on, in or around the heart of the subject, etc.
  • the memory 504 may be configured to receive instructions from the processor 514 for performing EP mapping and MRI simultaneously.
  • the instructions may be used for detecting if the plurality of electrodes 512 are working properly.
  • the instructions may be for sending signals to a device based on a voltage sent and received by each of the plurality of electrodes 512, for determining the power status of particular rows or columns of the plurality of electrodes 512 based on the signals received by the device, and for detecting if each electrode in the plurality of electrodes 512 is sending and receiving the correct voltage.
  • the EP mapping database 510 stored in the memory 504 may include one or more tables or other data structures. Such tables or other data structures may include subject health information, including parameters such as numbers of the plurality of electrodes 512, electrode position coordinates, time aligned electric field vectors, estimated local field propagation vectors, electrode configuration status and the like. This information may be used to determine various information about the heart of the subject, and the position of different ones of the plurality of electrodes 512 on, in or around the heart of the subject during EP mapping.
  • the EP mapping database 510 may store information related to the energy of each of the plurality of electrodes 512, which of the plurality of electrodes 512 are connected in series and/or in parallel, etc.
  • the EP mapping database 510 may further store information related to heart rate activity and power status of each of the plurality of electrodes 512.
  • the EP mapping database 510 may store information related to the age of the subject, the time for which the heart of the subject beats at different heart rates, the number of heartbeats per second, a computed maximum heart rate, a target heart rate, a heart rate status, the on/off status of different ones of the plurality of electrodes 512, etc.
  • the EP mapping database 510 may be configured to store information related to the number of the plurality of electrodes 512 which should be powered in the “on” and “off’ states.
  • the memory 504 may store information related to coronary artery level, patch data, MRI data, and Computer Tomography (CT) data.
  • the memory 504 may also store, in the EP mapping database 510 or in another database or data store, a detailed research report for detecting localized devices around the body of the subject.
  • Patch data stored in the memory 504 may include information associated with the connection of a set of patches including the multi-hub patch 506, as well as information related to the arrangement and distance between the plurality of electrodes 512 which are part of the multi-hub patch 506. For example, a set of 10 patches may be connected in a series or parallel arrangement, with an exact distance of 6 centimeters (cm) from one another.
  • the multi-hub patch 506 may include two or more areas or regions, with each of the two or more regions including a subset of the plurality of electrodes 512 which are managed by a corresponding one of the hubs 524.
  • the locations of each of the two or more regions on a substrate of the patch interface of the multi-hub patch 506 relative to one another (as well as the positioning of individual one of the plurality of electrodes 512 within each of the two or more regions) may be known, such that signaling collected from the different subsets of the plurality of electrodes 512 by the hubs 524 may be correlated with one another and used to build a “map” of activity of a larger area (e.g., an area spanning the two or more regions on the substrate of the patch interface of the multi-hub patch 506).
  • the memory 504 may also store, in the EP mapping database 510 or in another database or data store, information related to a local electric field over the body of the subject, images of a ventricular map constructed over the heart of the subject, types of electrical activity in the heart of the subject, etc.
  • the multi-hub patch 506 includes the plurality of electrodes 512, the processor 514, the measurement controller 516 implementing the frequency generator 518 and the row and column decoder 520, the power source 522, the plurality of hubs 524, the cross-point switch 526 and the communication device 528.
  • the plurality of electrodes 512 are arranged into two or more clusters or regions. Each electrode in the plurality of electrodes 512 may have a corresponding electrode identifier (ID). Each electrode of the plurality of electrodes 512 within a particular cluster or region may be electrically connected to a corresponding interface site.
  • the interface site may include a pattern of electrical contact pads arranged so as to align and couple with another set of contact pads.
  • FIG. 5 shows the system 500 including a single instance of the multi-hub patch 506
  • the system 500 may include multiple patches each configured in a manner similar to that described with respect to the multi-hub patch 506 (e.g., with each of the multiple multi-hub patches including a plurality of clusters of electrodes).
  • each cluster includes 4 or more of the plurality of electrodes 512, 8 or more of the plurality of electrodes 512, 10 or more of the plurality of electrodes 512, 12 or more of the plurality of electrodes 512, 16 or more of the plurality of electrodes 512, etc.
  • Each cluster may include at least one of the plurality of electrodes 512 that is electrically connected to at least one other one of the plurality of electrodes 512 from another one of the clusters.
  • Each interface site may include one or more alignment markings to facilitate interfacing with an associated module or hub (e.g., one of the hubs 524).
  • Each interface site may include one or more adhesive contacts arranged so as to couple with an associated module or hub when placed thereagainst.
  • multiple instances of the multi-hub patch 506 are placed on different sites on the body of the subject, such as on the sternum, the side of the torso, and the back.
  • the multi-hub patch 506 (or multiple instances of the multi-hub patch 506 and one or more patch-module pairs), may be worn as part of a procedural preparation to find the ectopic source of an arrhythmia, to determine the precise location of heart damage, etc.
  • the multi-hub patch 506 may be used for electrocardiography (ECG) applications.
  • the measurement controller 516 is configured to determine an amount of current or voltage, and the frequency of these to be generated, for each electrode of the plurality of electrodes 512.
  • the measurement controller 516 implements the frequency generator 518 and the row and column decoder 520.
  • the frequency generator 518 is used to set the frequency of signals of the plurality of electrodes 512.
  • a doctor or other user may be able to set the frequency of signals of different ones of the electrodes in the plurality of electrodes 512 by operating the frequency generator 518 in a “set” mode. While in the set mode, the frequency generator 518 generates a frequency at a set value for the plurality of electrodes 512.
  • the measurement controller 516 is configured to generate the frequency for each of the plurality of electrodes 512, based on their voltages or currents, through the frequency generator 518.
  • the measurement controller 516 is configured to send out, to a doctor or other user, information related to ones of the plurality of electrodes 512 which are at the “on” state and available for sensing.
  • the measurement controller 516 is configured to utilize the row and column decoder 520 to send signaling to individual ones of the plurality of electrodes 512.
  • the power source 522 of the multi-hub patch 506 is connected with the plurality of electrodes 512, and is configured to drive the multi-hub patch 506 and the plurality of electrodes 512.
  • the power source 522 may be wirelessly controlled by the measurement controller 516 or any other controller (e.g., including the processor 514), possibly based on input provided through or using the display interface 502.
  • the status of the power remaining for the power source 522 may be displayed by the display interface 502.
  • the power source 522 may be any type of power source which can be integrated into the multi-hub patch 506.
  • the power source 522 is formed of a non-ferrous battery.
  • the multi-hub patch 506 may be applied to the body of the subject using an adhesive.
  • the multi-hub patch 506, for example, may have a layer of adhesive to stick the multi-hub patch 506 to the body of the subject.
  • the adhesive may be any medicalgrade adhesive, which may be antibacterial and antiallergic to the subject’s body.
  • the system 500 may be configured to collect data from the plurality of electrodes 512 using the plurality of hubs 524.
  • the plurality of hubs 524 may be used to transfer data related to the plurality of electrodes 512 and the heart activity of the subject wirelessly to the communication device 528.
  • one or more of the plurality of hubs 524 may be configured with down-facing radar configured to examine the body of the subject mechanically, and with an ultrasound sensor configured to detect sounds produced due to the plurality of electrodes 512.
  • Each hub of the plurality of hubs 524 may be assigned a hub ID, which provides easy identification and location of different ones of the plurality of hubs 524.
  • the plurality of hubs 524 are placed out of the way for the MRI, so as to advantageously allow for simultaneous EP mapping and MRI using the multi-hub patch 506.
  • Each of the plurality of hubs 524 may deal with a subset of the plurality of electrodes 512 (e.g., with a single cluster of the plurality of electrodes 512 in a single region of a substrate of a patch interface of the multi-hub patch 506).
  • the plurality of hubs 524 may include stimulation components that inject signals into the plurality of electrodes 512.
  • the system 500 in some cases, may provide at least a portion of a CT system.
  • the cross-point switch 526 comprises a collection of switches arranged in a matrix configuration.
  • the cross-point switch 526 may have multiple input and output lines that form a crossed pattern of interconnecting lines between which a connection may be established by closing switches at intersections of the rows and columns.
  • the cross-point switch 526 may be configured to enable transmission of data related with stimulation of the plurality of electrodes 512 based on the voltage and current levels of the plurality of electrodes 512. Further, the cross-point switch 526 is configured to enable transmission or reception of information related with voltage received and sent by the plurality of electrodes 512, information related to the on/off state of each of the rows and columns of the plurality of electrodes 512, etc.
  • the communication device 528 is configured to transfer data related to the subject’s health from the multi-hub patch 506 to the display interface 502, and possibly to one or more other devices or systems (e.g., in the context of the system 300, the wearable device 302, the wireless gateway 340, the Al wearable device network 348, one or more of the third-party networks 368, etc.).
  • the display interface 502 may facilitate a doctor or another user to view information related to the multi-hub patch 506.
  • the communication device 528 may be configured to transfer data related to the subject to the memory 504 (e.g., for storage in the EP mapping database 510 or another database or data store).
  • Such data may include the heartbeat per second of the subject, the target heart rate range of the subject, the maximum heart rate of the subject, etc.
  • the communication device 528 may transfer information related to the working of the plurality of electrodes 512 (e.g., such as the voltage and current levels of the plurality of electrodes 512) to any other device.
  • the system 500 may be configured to measure activity between the plurality of electrodes 512.
  • a heart surgeon, doctor or other user can easily know the locations of each of the plurality of electrodes 512 relative to one another (e.g., each of the plurality of electrodes 512 may be at a same or otherwise known distance from one another on the multi-hub patch 506), thereby leading to generation of an efficient and reliable ventricular map of the heart of the subject.
  • the system 500 may be used for surgical planning. For example, a surgical plan may be designed based on the way that a heart surgery or a heart bypass for the subject needs to be carried out depending on the distance and locations of the plurality of electrodes 512 relative to one another.
  • the system 500 may be configured to map ectopic activity and areas in the subject’s cardiovascular system.
  • the system 500 may also be used to create a local electric field over the body of the subject, and to construct a map over the heart of the subject.
  • the processor 514 of the multi-hub patch 506 may be used for such analysis, or the multi-hub patch 506 may act simply to send data to an external computer or device for such analysis and processing.
  • the network interface 508 facilitates a communication link among the different components of the system 500, including the display interface 502, the memory 504 and the multi-hub patch 506, and possibly other devices and systems (e.g., in the context of the system 300, the wearable device 302, the wireless gateway 340, the Al wearable device network 348, one or more of the third-party networks 368, etc.).
  • the network interface 508 may be a wired and/or a wireless network.
  • the network interface 508, if wireless, may be implemented using communication techniques such as Visible Light Communication (VLC), Worldwide Interoperability for Microwave Access (WiMAX), Long Term Evolution (LTE), Wireless Local Area Network (WLAN), Infrared (IR) communication, Public Switched Telephone Network (PSTN), Radio waves, and other communication techniques, known in the art.
  • VLC Visible Light Communication
  • WiMAX Worldwide Interoperability for Microwave Access
  • LTE Long Term Evolution
  • WLAN Wireless Local Area Network
  • IR Infrared
  • PSTN Public Switched Telephone Network
  • Radio waves and other communication techniques, known in the art.
  • the system 500 may implement a plurality of modules to evaluate and enhance the performance of EP mapping and MRI, with both being performed at the same time.
  • the modules may enhance the performance of the EP mapping by turning on and off respective ones of the plurality of electrodes 512 based on the voltages sent and received by each electrode in the plurality of electrodes 512.
  • the modules include a base module 530 which is communicatively coupled with the display interface 502, the memory 504 and the multi-hub patch 506 via the network interface 508.
  • the base module 530 may be configured to manage health parameters related to the subject including, but not limited to, the heartbeats of the subject per second, the maximum heart rate of the subject, the target heart rate of the subject, and the heart rate status of the subject.
  • the base module 530 is configured to activate and/or deactivate various sub-modules according to the information about the subject and the working of the plurality of electrodes 512 (e.g., received from the memory 504 and/or the multi-hub patch 506).
  • Such sub-modules include the data collection module 532, the set-up module 534, the stimulation module 536, the monitoring module 538, the lead equivalent module 540 and the on-board test module 542.
  • the base module 530 may act as a central controller or module that receives and sends instructions to each of the submodules.
  • the data collection module 532 is configured to collect data related to the voltage and current levels of the plurality of electrodes 512.
  • the data collection module 532 may also be configured to collect the information related with the working of the plurality of electrodes 512 and information related to the subject. Such information may correspond to heartbeats per second of the subject, the target heart rate range of the subject, the maximum heart rate of the subject, etc.
  • the data collection module 532 is further configured to collect information related with stimulation of the plurality of electrodes 512 based on the voltage and/or current levels of the plurality of electrodes 512.
  • the data collection module 532 may be associated with multiple sensors including but not limited to postural sensors, barometers, movement sensors, ultrasound sensors, optical interfacial sensors, impedance sensors, bio-sensors, etc.
  • the base module 530 utilizes the set-up module 534 to perform setup for the plurality of electrodes 512, and for detecting proper working of the plurality of electrodes 512.
  • the setup module 534 may be configured to determine or set a voltage or current frequency for each of the plurality of electrodes 512 at a particular value (e.g., of current and/or voltage sent and/or received by each of the plurality of electrodes 512). Further, the set-up module 534 is configured to determine whether the plurality of electrodes 512 are working properly.
  • the stimulation module 536 is configured to apply stimulation using at least one electrode of the plurality of electrodes 512.
  • the stimulation module 536 is configured to determine data related to the stimulation of different ones of the plurality of electrodes 512, based on the voltage values of each of the plurality of electrodes 512.
  • the base module 530 receives a signal related to one or more of the plurality of electrodes 512 which are to be stimulated, with the base module 530 activating and deactivating the stimulation module 536 based on the stimulation of the plurality of electrodes 512.
  • the stimulation module 536 is configured to receive data related to stimulation of the plurality of electrodes 512 based on voltage values sent and received by the processor 514.
  • the base module 530 utilizes the monitoring module 538 to detect and monitor information related to the plurality of electrodes 512. Such information may include, but is not limited to, heat generated by the plurality of electrodes 512 due to excessive radiation on the body of the subject while the subject is undergoing simultaneous EP mapping and MRI.
  • the monitoring module 538 is also configured to receive and monitor information related to heartbeats of the subject per second, the maximum heart rate of the subject, the heart rate status of the subject, etc.
  • the monitoring module 538 is further configured to monitor the voltage sent and received by each electrode of the plurality of electrodes 512.
  • the lead equivalent module 540 is configured to detect data associated with the number of lead equivalents of the plurality of electrodes 512. In some embodiments, the lead equivalent module 540 is configured to find a 12-lead equivalent of the data received from the multi-hub patch 506. The lead equivalent module 540 may be controlled wirelessly, or via one or more wires. The lead equivalent module 540 may also be configured to determine a correlation between data extracted from the multi-hub patch 506 and the data related with the corresponding number of lead equivalents. The lead equivalent module 540 may be fed with a correlation algorithm, and takes into account detection, monitoring anticipation and calculation of the number of lead equivalents. The correlation algorithm may be run on the EP mapping database 510 to visualize various aspects related to electrical activity in the heart of the subject.
  • the correlation algorithm may be configured to figure out different variations between the electrical activity and the mechanical activity of the heart of the subject.
  • the lead equivalent module 540 (as well as other sub-modules of the base module 530 and the base module 530 itself) may run on the processor 514 of the multi-hub patch 506, on one or more of the plurality of hubs 524, on an external device or server (e.g., a host device or gateway in communication with the multi-hub patch 506 via the network interface 508, a cloud-based data service, etc.).
  • the on-board test module 542 is configured to test the working of the plurality of electrodes 512. In some embodiments, the on-board test module 542 is configured to measure the number of rows and/or columns decoded using the row and column decoder 520. The onboard test module 542 may be configured to enable the generation of voltage or current frequency at a desired voltage or current level for different ones of the plurality of electrodes 512. The on-board test module 542 may also be configured to facilitate monitoring of the right voltage or current sent and received by each of the plurality of electrodes 512. It should be noted that the on-board test module 542 may measure the information corresponding to the frequency generator 518 and the row and column decoder 520. The system 500 enables simultaneous EP mapping and MRI, thus facilitating efficient use of both technologies with minimum interference of metal electrodes. In addition, the system 500 eliminates the requirement of human intervention during such operations.
  • the system 500 includes a local anesthetic and enables a doctor or other user to annotate data related with heart activity of the subject to add metadata in association with data obtained from the multi-hub patch 506.
  • a metal-oxide-semiconductor field-effect transistor (MOSFET) switch may be located at the intersection of each row and each column of the plurality of electrodes 512.
  • the MOSFET switches are able to open up the source to the drain to create current through the body of the subject that the multi -hub patch 506 is attached to.
  • the MOSFET on the other side of the system 500 is able to open up the source to the drain to measure the current flowing through the body of the subject.
  • the process flow 600 starts in step 601, where the base module 530 initiates one or more of the plurality of electrodes 512 and hubs 524 to perform physiologic monitoring (e.g., such as to enhance performance of a subject, track heart activity of the subject, etc.).
  • the base module 530 utilizes the data collection module 532 to retrieve information related to the multi-hub patch 506 (and possibly one or more other patches), and data related to the plurality of electrodes 512 (and possibly other sets of electrodes of one or more other patches).
  • Such information and data may be obtained directly from the multi-hub patch 506 and the plurality of electrodes 512, via one or more of the plurality of hubs 524, from the EP mapping database 510 stored in memory 504, combinations thereof, etc.
  • the patch-related data retrieved in step 603 may include, for example, information associated with the total number of instances of the plurality of hubs 524 of the multi-hub patch 506 which are being used, as well the total numbers of the plurality of electrodes 512 being used by each instance of the plurality of hubs 524 of the multi-hub patch 506.
  • the data related with the plurality of electrodes 512 may include, but is not limited to, electrode position coordinates, time aligned electric field vectors, estimated local field propagation vectors, electrode configuration status, etc.
  • the data related with the plurality of electrodes 512 may include voltage and/or current levels of each electrode of the plurality of electrodes 512.
  • Data related to the plurality of electrodes 512 may, in some cases, be collected utilizing the plurality of hubs 524 and then supplied to the data collection module 532.
  • the base module 530 may utilize the data collection module 532 to retrieve information from the EP mapping database 510 indicating that four electrodes E1-E4 are used for performing EP mapping and MRI simultaneously.
  • the base module 530 utilizes the set-up module 534 to determine information related to the working of the plurality of electrodes 512. Such information may include, for example, a frequency to be set based on the data related to the plurality of electrodes 512.
  • the set-up module 534 may detect if the plurality of electrodes 512 are working properly.
  • the information related to the working of the plurality of electrodes 512 and the frequency to be set based on the voltage of the plurality of electrodes 512 may correspond to particular voltage and/or current levels.
  • the base module 530 may utilize the set-up module 534 to determine voltage and/or current levels of the electrodes E1-E4.
  • the base module 530 utilizes the stimulation module 536 to determine information related to the stimulation of the plurality of electrodes 512.
  • the information related to the stimulation of the plurality of electrodes 512 may correspond to the voltage applied, the ones of the plurality of electrodes 512 which are stimulated, etc.
  • the base module 530 determines that, for the electrodes E1-E4, the electrodes E2 and E3 need to be stimulated based on the location of the electrodes E2 and E3 on the ribcage of Alex to provide MRI (or other physiologic monitoring) of Alex’s rib area.
  • the base module 530 utilizes the monitoring module 538 to determine information related to the subject on which the multi -hub patch 506 is placed.
  • the information related to the subject may include, for example, the heartbeats per second and/or the heartbeat rate corresponding to particular ones of the plurality of electrodes 512.
  • the monitoring module 538 may determine that the subject Alex has a target heart rate range of 108-153, and a current heartbeat rate of 180. It should be noted that a single heartbeat may last one second or less, and a single heartbeat mapping may take 0.5-1 second.
  • the base module 530 utilizes the lead equivalent module 540 in step 611 to correlate the data from the multi-hub patch 506 with data related to the lead equivalents of the plurality of electrodes 512.
  • the base module 530 may further correlate data from the multi-hub patch 506 with historical data that can be correlated with measurements that relate to heart conditions, heart electrodes or other heart inserts.
  • the data received from the multi-hub patch 506 may correspond to the number of the plurality of electrodes 512 in the multi-hub patch 506, and the number of active ones of the plurality of electrodes 512 in the multi-hub patch 506.
  • the number of patches used is two and thus the lead equivalents corresponding to the two patches is one.
  • the base module 530 utilizes the on-board test module 542 to send a signal to the plurality of electrodes 512 corresponding to the lead equivalents.
  • signaling sent in step 613 may be used to test the plurality of electrodes 512 of the multi-hub patch 506.
  • the signaling may be sent to a predefined set of the plurality of electrodes 512.
  • the on-board test module 542 may send an activating signal to the four electrodes E1-E4.
  • the base module 530 in step 615 determines information related to the heart activity of the subject.
  • the base module 530 may receive information that there is a target heart rate range of 114-162 and a heartbeat rate of 190.
  • the base module 530 in step 617 sends information related to the heart activity of the subject to a doctor or other user via the display interface 502.
  • the base module 530 may send information that the heart activity of Alex is detected as low, normal or high.
  • the process flow 600 then ends in step 619.
  • FIG. 7 shows an example of a multi-hub patch 700 comprising a plurality of electrodes 702.
  • Sets of the plurality of electrodes 702 are arranged into different electrode clusters, including electrode cluster 704.
  • the electrode cluster 704 includes nine electrodes 702.
  • Two other electrode clusters also include nine of the electrodes 702.
  • each electrode cluster may include any number of electrodes, such as 4 or more electrodes, 8 or more electrodes, 10 or more electrodes, 12 or more electrodes, 16 or more electrodes, etc.
  • Each of the electrode clusters may be associated with a data collection module of hub including a power supply, a processor, a memory and a transceiver.
  • the electrode cluster 704 is associated with data collection module 706.
  • the data collection modules or hubs are connected to the plurality of electrodes 702 via electrical interfaces.
  • the data collection module 706 is connected with ones of the plurality of electrodes 702 in the electrode cluster 704 via the electrical interfaces 708.
  • the use of multiple data collection modules or hubs advantageously allows the electrical interfaces 708 (e.g., wiring) to be shorter than would otherwise be required if a single data collection module or hub were used to interface with all of the plurality of electrodes 702.
  • the multi-hub patch 700 further includes a skin interface 710.
  • the skin interface 710 may be a thin-film structure for affixing the multi-hub patch 700 on the body of a subject (e.g., similar to the construction of the patches in the patch-module pairs of FIG. 1).
  • the skin interface 710 may include the plurality of electrodes 702 arranged into electrode clusters including the electrode cluster 704, where each of the electrodes 702 within a given electrode cluster (e.g., electrode cluster 704) is electrically connected to a data collection module (e.g., data collection module 706) via electrical interfaces (e.g., electrical interfaces 708).
  • the multi-hub patch 700 may be worn as part of a procedural preparation, to find the ectopic source of an arrhythmia, to determine the precise location of heart damage, etc.
  • the multi-hub patch 700 includes three data collection modules and three electrode clusters each with nine electrodes.
  • the multi-hub patch 700 also includes one or more optional vibration elements 712, which may be configured to at least one of initiate vibration and/or measure a vibration stimulus.
  • the vibration elements 712 may include vibrators which are able to generate impulse or vibration signals, with the electrodes 702 or other sensors being configured to receive such impulse or vibration signals to determine spatial distribution information.
  • the multi -hub patch 700 of FIG. 7 is advantageously configured to monitor a relatively large area of an associated subject, particularly where it is desired to precisely know the relative locations of the plurality of electrodes 702 in order to correlate signaling received therefrom to map heart or other activity of the subject.
  • multi-hub patch 700 attached to a chest of a subject 801, configured for monitoring heart activity of the subject 801. It should be noted, however, that the placement of the multi-hub patch 700 on the subject 801 as shown in FIG. 8 is presented by way of example only.
  • the multi-hub patch 700 may be placed on different areas of the subject 801 as needed or desired. Further, different types of multi-hub patches may also be used, with different numbers and arrangements of electrode clusters.
  • FIG. 9 shows an example of a multi-hub patch 900 with a different physical arrangement of electrodes clusters than the multi-hub patch 700.
  • the multi-hub patch 900 similar to the multi-hub patch 700, includes a plurality of electrodes 902 which are arranged in multiple electrode clusters, including electrode cluster 904, with each cluster of the plurality of electrodes 902 being associated with a data collection module or hub, such as the data collection module 906 associated with the electrode cluster 904.
  • the data collection module 906 (and other ones of the data collection modules or hubs) are interconnected with ones of the plurality of electrodes 902 in its electrode cluster 904 via electrical interfaces 908.
  • the plurality of electrodes 902 are disposed on a skin interface 910 of the multi-hub patch 900.
  • the electrode clusters of the multi-hub patch 900 are arranged linearly relative to one another, as compared with the electrode clusters of the multi-hub patch 700 which are arranged in a triangular pattern.
  • FIGS. 10 and 11 show two examples of placement locations for the multi-hub patch 900 on subjects 1001 and 1101, respectively.
  • FIG. 10 shows the multi-hub patch 900 of FIG. 9 attached to a forehead of the subject 1001
  • FIG. 11 shows the multi -hub patch 900 of FIG. 9 attached to a ribcage of the subject 1101.
  • Different types of multi-hub patches e.g., with different numbers and arrangements of electrode clusters
  • Illustrative embodiments provide systems and methods for performing simultaneous or concurrent EP mapping and MRI to assess a subject’s heart activity.
  • the system includes one or more multi-hub patches, with each multi-hub patch including a plurality of electrodes attached to the body of the subject for monitoring electrical signals from the subject’s body.
  • Each of the multi-hub patches may also include or be associated with a plurality of hubs or modules connected with the plurality of electrodes, the plurality of hubs or modules are configured to facilitate data collection from the plurality of electrodes.
  • One or more processors may be wirelessly coupled to the one or more multi-hub patches, the plurality of electrodes, and the plurality of hubs or modules.
  • the one or more processors are configured to receive information related to the one or more multi-hub patches and the subject.
  • the information related to the one or more multi-hub patches may include information related to the working of the plurality of electrodes, information related to the lead equivalents of the one or more multi-hub patches, etc. Based on correlations and analysis of such data, signaling is sent to the plurality of electrodes and corresponding heart activity of the subject is recorded and sent to a display interface (e.g., for use by a doctor or other user).
  • the correlations may include correlating information related to the one or more multi-hub patches with data related to one or more heart conditions of the subject, the position of the multi-hub patches (or electrodes thereof) in, on or around the heart of the subject, etc.
  • Multi-hub patches as described herein may be used in conjunction with or for techniques involving heart-to-torso surface mapping, surface field measurement sites, single beat atrial mapping, and 12-lead equivalent mapping algorithms.
  • a 12-lead electrocardiogram is a collection of recordings from the torso of a subject, with electrodes being positioned precisely at predetermined locations on the torso and predetermined lead configuration measured between the electrodes. Often, precise localization of the correct electrode placement sites for obtaining a 12-lead electrocardiogram can be challenging due to many factors. In addition, traditional 12-lead electrode locations may not be comfortable for long-term recordings from a subject.
  • a wearable electrophysiological system includes a set of electrodes, embedded into one or more patches, the one or more patches being configured for stretchability and wearability on the subject.
  • patches may include patch-module pairs (e.g., as shown in FIG. 1), multi-hub patches (e.g., as shown in FIGS. 7 and 9), combinations thereof, etc.
  • the electrodes on such patches may be sized to provide precise electrophysiological recording sites, such as a characteristic diameter less than 15mm, less than 10mm, less than 7mm, less than 5mm, less than 3mm, or the like.
  • the electrodes may be any shape - the characteristic diameter herein is used to describe only the general size of the electrode in a substantially planar direction.
  • the system may include one or more patches (e.g., patch-module pairs and/or multi-hub patches), with each patch being attachable to a location on the body of the subject, and with each patch including generally two or more electrodes between which electrophysiological measurements can be made during use.
  • patches e.g., patch-module pairs and/or multi-hub patches
  • a patch may include a small number of electrodes, such as 2 or 3. In other embodiments, a patch may include 4-6 electrodes, 8-16 electrodes, 16-32 electrodes, 32-64 electrodes, more than 64 electrodes, etc.
  • the electrodes may be routed to a plurality of wearable devices, which can be attached to the patches. Patches may be distributed over the subj ect, preferably in a manner that is comfortable to wear and/or works around challenging features on the body, such as breast tissue, tissue folds, and the like. The electrodes facilitate measurement of electrical potentials on the body of the subject. Collectively, a map of the measured potentials over the surface of the subject may be constructed therefrom.
  • the signals may be sampled at a rate sufficiently high so at to determine, with sufficient acuity, the temporal and spatial signal across most, if not all, of the electrodes. Such signals may be sampled at 250Hz, 500Hz, 1kHz, 2kHz, or the like. The higher sampling rates may be advantageous to determine accurate features of the waveform during use.
  • multi-hub patches may be used to facilitate mapping over a large surface of the subject. The use of multi-hub patches, however, is not a requirement for determining 12-lead equivalents.
  • the system may be configured to receive one or more stimuli, originating from one or more of the electrode sites, and/or from a dedicated site, etc.
  • the stimuli may be received by one or more of the electrodes, and recorded.
  • the individual recordings of the stimulus may be suitable for determining the electrode locations with respect to each other on the torso of the subject (e.g., in conjunction with a propagation model described below).
  • the heart is oriented within the torso of the subject.
  • the heart is oriented along a heart axis which can be measured with respect to one or more body reference frames.
  • the heart axis can change with posture, respiration depth, muscle contraction, bending of the torso, twisting of the torso, with stress levels, etc.
  • a database of heart axis and heart orientations with respect to body frames of reference may be constructed from a series of imaging studies, MRI studies, and/or CT studies of one or more subjects.
  • a database of such information may be constructed from a wide range of subjects, body types, etc.
  • 3D torso models and/or images of the torso of the subjects may be collected as well.
  • the database may be comprehensively constructed from a range of subjects in different body conditions and the like.
  • one or more systems in accordance with this disclosure may be worn by each subject to simultaneously collect electrical signals from the electrodes in each posture, and within each portion of the respiration cycle.
  • the electrical function of the heart may include one or more signal propagation issues (e.g., a re-entrant signal, a blockage, a slowed propagation rate, an electrical storm, etc.), one or more ischemic issues, one or more spasms, etc.
  • the signals from the recorded electrodes may be transformed into a standard configuration which is more recognizable to a healthcare worker, a physician, a nurse, etc.
  • Data collection studies may include determining the functional state of the heart along with the anatomical correlations to the electrode positions on the torso of the subject.
  • the 3D-torso information and/or images, the internal makeup of the torso may collectively be described as a heart-to-torso spatial correlational database (HTSCD).
  • the HTSCD may be used to train a correlational model, to confirm training of the correlational model, to extend training of the correlational model, and/or to develop subsets of the population such that a transformation model may be constructed relating the signals obtained by the electrodes to the orientation and functional state of the heart of a subject.
  • the system may include one or more adjunct sensors, such as one or more orientation sensors (e.g., accelerometers, gyroscopes, magnetometers, combinations thereof), one or more height sensors (e.g., barometers), one or more vibration sensors, one or more stimuli generators (e.g., to generate and/or receive signaling from one or more of the sensors on the body), etc.
  • orientation sensors e.g., accelerometers, gyroscopes, magnetometers, combinations thereof
  • height sensors e.g., barometers
  • vibration sensors e.g., to generate and/or receive signaling from one or more of the sensors on the body
  • stimuli generators e.g., to generate and/or receive signaling from one or more of the sensors on the body
  • Such sensors may be distributed over the torso so as to assist with determining the locations of the electrodes thereupon, the posture of the subject, the torso configuration of the subject (e.g., bending, twisting, folding, etc
  • the wearable devices may include one or more movement or vibration sensors, such that the wearable devices can detect the impulse and/or vibration as well as collect cardiac mechanogram information directly from the movements of the heart within the torso of the subject.
  • a 12-lead electrocardiogram is measured by placing electrodes on specific locations on the torso of the subject.
  • the anatomy of the subject may be such that electrode placement at the intended 12-lead locations is difficult.
  • the skill level with which the electrodes are applied, and the locations selected for the analysis may not be very good.
  • the models described herein may be suitable for providing a corrected 12-lead analysis from inaccurately placed electrodes.
  • the models described herein may provide suitable reconstruction of the heart function from the electrode recordings on the torso, such that the visualization may be provided to a user for decision making.
  • a first spatial model is computed to estimate the locations of the electrodes on the torso of the subject and/or to classify the torso-type or torso features of the subject.
  • the spatial model accepts the electrical inputs, spatial inputs, adjunct sensor inputs from the sensors, one or more images, etc., and generates the approximate locations of the electrodes on the torso of the subject.
  • the spatial model may be trained on raw data from the electrical inputs, adjunct sensor inputs, etc. The changes in the characteristics and signal morphology of these signals contribute analysis features to the spatial model.
  • the sub-waveforms of the measured electrocardiograms from the electrical input sites may include information related to: the relative heart axis from the input sites; changes in the heart axis from the input sites with posture and/or respiration changes; changes in the distance between the heart and the sites; etc.
  • adjunct sensors may provide additional information for the spatial model, so as to ensure that the approximate electrode sites estimated by the spatial model are sufficiently accurate for further analysis.
  • the system may also include an additional transformational model.
  • the transformational model is built in order to transform the signals measured from the input sites into appropriate signals that would occur at the transformed locations (e.g., 12-lead locations, corrected 12-lead locations, direct heart signal map, etc.).
  • the transformation model may accept recordings from the electrode sites as well as optionally one or more adjunct sensors, and utilize such recordings along with information regarding one or more anatomical features of the torso of the subject (e.g., a 3D surface model of the subject).
  • the transformation model may include or utilize one or more machine learning algorithms (e.g., a convolutional neural network (CNN) or other type of deep learning system) to determine one or more of a heart orientation, heart size, estimated heart position within the torso, electrophysiological signals approximated on the surface of the heart, and the estimated signals that would be measured at one or more of the target sites (e.g., 12-lead sites, corrected 12-lead sites, etc.).
  • machine learning algorithms e.g., a convolutional neural network (CNN) or other type of deep learning system
  • the transformation model may accept input signals (e.g., from electrode sites of electrodes on one or more patches) and a set of approximated electrode locations on the torso of the subject. Using such inputs, the transformation model generates one or more outputs related to equivalent signals for the intended transformed locations (e.g., 12-lead sites, corrected 12-lead sites, etc.). The transformation model may also or alternatively be used to generate a heart functional model for direct display.
  • the transformation model may include: a three-dimensional electromagnetic inverse model that simulates and back- propagates the heart function from the inputs; a spatial model to calculate orientation parameters and spatial configuration parameters from the inputs (and possibly extra adjunct sensor inputs); and a forward model to generate the expected transformed electrical signals for the intended electrode locations (e.g., 12-lead sites, corrected 12-lead sites, etc.) for the subject.
  • a three-dimensional electromagnetic inverse model that simulates and back- propagates the heart function from the inputs
  • a spatial model to calculate orientation parameters and spatial configuration parameters from the inputs (and possibly extra adjunct sensor inputs)
  • a forward model to generate the expected transformed electrical signals for the intended electrode locations (e.g., 12-lead sites, corrected 12-lead sites, etc.) for the subject.
  • the inverse electromagnetic model may include a map of classifications of approximate 3D torso compositional models, a parametric EM transport model, and one or more machine learning models that are trained from fully simulated 3D signal propagation information between the heart and torso of one or more subjects (e.g., where the tissue makeup of the model may be constructed from actual imaging of the torsos of the subjects), etc.
  • the inverse electromagnetic model may include a series of 3D models (e.g., torso compositional models, which may be or be derived from a reference set of models determined from one or more previous studies, from a collection of 3D images, etc.).
  • the physiologic signal mapping platform 1215 comprises a spatial correlation database 1220 (e.g., a HTSCD) which stores information related to subject body types and associated information (e.g., imaging or modeling) of anatomical information for a range of subjects.
  • the physiologic signal mapping platform 1215 further implements wearable device spatial modeling logic 1225, which is configured to determine locations of the wearable devices 1205, or of portions or components thereof (e.g., different ones of the electrodes or electrode clusters of a multi-hub patch or patch-module pairs) on the subject 1201, possibly using information from the spatial correlation database 1220.
  • physiologic signal mapping platform 1215 may, in some cases, be implemented at least in part internal to the wireless gateway 1210 and/or one or more of the wearable devices 1205.
  • the physiologic signal mapping platform 1215 may also or alternatively be part of an Al wearable device network (e.g., the Al wearable device network 348 in the system 300, via the physiologic signal mapping module 392).
  • the set of electrodes are arranged in two or more electrode clusters at different regions of a multi-hub patch, where the locations of the two or more electrode clusters at the different regions of the multi-hub patch are known relative to one another (e.g., the distance between different electrode clusters, and/or the distances between electrodes within and across different electrode clusters, are known).
  • an equivalent body surface potential map is generated from the collected electrophysiologic signals.
  • a transformed set of electrophysiologic signals for a second set of locations on the body of the subject e.g., desired electrode locations, such as a 12-lead site configuration, corrected 12-lead sites, etc.
  • the transformed set of electrophysiologic signals is determined based at least in part on predictions generated using the equivalent body surface potential map generated in step 1303.
  • the equivalent body surface potential map may be generated at least in part utilizing a synthetic inverse electromagnetic signal model.
  • the process flow 1300 may utilize one or more physically interactable devices for calibrating at least a portion of a 3D model of the body of the subject, where the equivalent body surface potential map is generated at least in part utilizing the 3D model of the body of the subject.
  • the 3D model of the body of the subject may be calibrated, for example, utilizing one or more pictures or images of a torso of the subject, injecting an acoustic signal and measuring the response to the acoustic signal at multiple sites (e.g., the first set of locations on the body of the subject where the electrophysiologic signals are collected from).
  • the process flow 1300 may also incorporate various individual characteristics of the subject, such as the subject’s lung morphology, past medical history, etc.
  • Body type classifications, body mass index (BMI), height, medications, body fat percentage, VO2 max, and other information may be considered or utilized as inputs to the 3D model of the body of the subject, to allow for personalized adjustments thereto to capture the diversity of anatomy expected to be seen across subject populations. Anything specific to the subject which may impact the equivalent body surface potential map may be used. As data is collected over time, the 3D model of the body of the subject can be adjusted accordingly, to improve the precision of the transformed signal predictions.
  • orientation of the set of electrodes or one or more hubs/modules interconnected with different ones of the electrodes at the first set of locations on the body of the subject may be used to improve the initial placement location estimates.
  • the equivalent body surface potential map e.g., a computational body surface potential map
  • a second model e.g., for the second set of locations is created (e.g., as an expected multichannel ECG from the equivalent body surface potential map).

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Abstract

Un appareil comprend au moins un dispositif de traitement conçu pour collecter des signaux électrophysiologiques provenant d'une pluralité d'électrodes au niveau d'un premier ensemble d'emplacements sur un corps d'un sujet. Le ou les dispositifs de traitement sont également conçus pour générer un mappage du potentiel de surface corporelle du sujet sur la base, au moins en partie, de la corrélation des signaux électrophysiologiques les uns avec les autres, les corrélations étant basées au moins en partie sur des estimations de distances entre différents emplacements du premier ensemble d'emplacements. Le ou les dispositifs de traitement sont en outre conçus pour déterminer des signaux électrophysiologiques transformés pour un second ensemble d'emplacements sur le corps du sujet différent du premier ensemble d'emplacements sur le corps du sujet, les signaux électrophysiologiques transformés étant déterminés sur la base, au moins en partie, du mappage généré du potentiel de surface corporelle du sujet.
PCT/US2024/050497 2023-10-20 2024-10-09 Systèmes et procédés d'évaluation de l'activité cardiaque d'un sujet Pending WO2025085288A1 (fr)

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US20070225611A1 (en) * 2006-02-06 2007-09-27 Kumar Uday N Non-invasive cardiac monitor and methods of using continuously recorded cardiac data
US20080161671A1 (en) * 2006-12-29 2008-07-03 Voth Eric J Body surface mapping system
US20120310066A1 (en) * 2008-05-01 2012-12-06 Magnetecs, Inc. Method and apparatus for creating a high resolution map of the electrical and mechanical properties of the heart
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