WO2025042661A2 - Rapid deployment physiologic monitoring kits - Google Patents

Rapid deployment physiologic monitoring kits Download PDF

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Publication number
WO2025042661A2
WO2025042661A2 PCT/US2024/042300 US2024042300W WO2025042661A2 WO 2025042661 A2 WO2025042661 A2 WO 2025042661A2 US 2024042300 W US2024042300 W US 2024042300W WO 2025042661 A2 WO2025042661 A2 WO 2025042661A2
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WO
WIPO (PCT)
Prior art keywords
devices
physiologic monitoring
unit
carrying case
physiologic
Prior art date
Application number
PCT/US2024/042300
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French (fr)
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WO2025042661A3 (en
Inventor
Landy Toth
Robert S. Schwartz
Jonathan G. Schwartz
Charles David FAUST
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Lifelens Technologies, Inc.
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Application filed by Lifelens Technologies, Inc. filed Critical Lifelens Technologies, Inc.
Publication of WO2025042661A2 publication Critical patent/WO2025042661A2/en
Publication of WO2025042661A3 publication Critical patent/WO2025042661A3/en

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Classifications

    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06NCOMPUTING ARRANGEMENTS BASED ON SPECIFIC COMPUTATIONAL MODELS
    • G06N20/00Machine learning
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06QINFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q50/00Information and communication technology [ICT] specially adapted for implementation of business processes of specific business sectors, e.g. utilities or tourism
    • G06Q50/10Services
    • G06Q50/26Government or public services
    • G06Q50/265Personal security, identity or safety
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H15/00ICT specially adapted for medical reports, e.g. generation or transmission thereof
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/70ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/80ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for detecting, monitoring or modelling epidemics or pandemics, e.g. flu

Definitions

  • the present disclosure relates to the field of physiologic monitoring and, more particularly, to devices and systems for physiologic monitoring.
  • Illustrative embodiments provide rapid deployment physiologic monitoring kits.
  • a physiologic monitoring kit comprises a carrying case comprising a computation unit comprising at least one processing device comprising a processor coupled to a memory, a communications unit comprising at least one network interface, a display unit comprising at least one display, a housing comprising at least one compartment, and a power supply unit comprising at least one power supply, the power supply unit being configured to power the computation unit, the communications unit and the display unit.
  • the physiologic monitoring kit also comprises a plurality of deployable devices housed in the at least one compartment.
  • the computation unit is configured to manage pairing of respective ones of the plurality of deployable devices with one or more subjects.
  • the computation unit is also configured to join, via the communications unit, a mesh network for a local monitoring environment wherein at least one of the paired ones of the plurality of deployable devices has been deployed.
  • the computation unit is further configured to obtain, via the mesh network, physiologic monitoring data associated with at least one of the one or more subjects from at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
  • the computation unit is further configured to control output of at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of information generated therefrom on the display unit.
  • the carrying case may further comprise one or more lights, the one or more lights being configured for illuminating at least a portion of the at least one compartment.
  • the power supply unit may be further configured to charge at least one of the plurality of deployable devices.
  • the plurality of deployable devices may comprise one or more gateway devices, one or more sensing devices configured for pairing with the one or more gateway devices, and one or more smart devices.
  • At least a given one of the one or more sensing devices may comprise a reusable component and a disposable component, the at least one compartment comprising a first compartment comprising at least one mount for attachment of the reusable component and a second compartment for storage of the disposable component.
  • the mesh network may be formed on one or more physical layers, each of the one or more physical layers comprising a range of frequency bands upon which data can be transferred, and the mesh network may utilize at least one mesh protocol based on at least one of a long range (LoRa) evolution schema, an ultrawideband (UWB) mesh protocol, a Bluetooth Low Energy (BLE) mesh protocol, a WiFi mesh protocol, a HaLow mesh protocol, and a private 5G mesh protocol.
  • LiRa long range
  • UWB ultrawideband
  • BLE Bluetooth Low Energy
  • the computation unit may be further configured to utilize the communications unit to establish a data link, distinct from the mesh network, with at least one external system outside the local monitoring environment.
  • the at least one external system may comprise a remote medical facility.
  • the data link may comprise a cellular network connection, the cellular network connection comprising at least one of a very high frequency (VHF), ultra high frequency (UHF) long-range radio connection, a tactical radio network connection, a Long- Term Evolution (LTE) cellular wide area network (WAN), and a 5G cellular WAN.
  • the computation unit may be further configured to provide at least a portion of the obtained physiologic monitoring data or at least a portion of the information generated therefrom to the at least one external system via the data link.
  • the carrying case may further comprise a data storage unit comprising one or more storage devices, and the computation unit may be further configured to store at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit.
  • the storage of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit may be performed responsive to the computation unit being unable to establish, via the communications unit, a data link with the at least one external system outside the local monitoring environment.
  • the at least one display of the display unit may comprise a touchscreen display, and the computation unit may be configured to provide, via the touchscreen display, user interface features enabling dynamic selection of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom to output on the display unit.
  • the dynamic selection may be between two or more different ones of the one or more subjects, between the portion of the obtained physiologic monitoring data and the portion of the information generated therefrom, between two or more different portions of the obtained physiologic monitoring data and two or more different portions of the information generated therefrom, combinations thereof, etc.
  • the computation unit may be further configured to generate one or more monitoring reports for at least one of the one or more subjects based at least in part on the obtained physiologic monitoring data, and wherein said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom that is output on the display unit comprises at least one of the one or more monitoring reports.
  • the computation unit may be further configured to generate one or more treatment reports for at least one of the one or more subjects based at least in part on the obtained physiologic monitoring data, and wherein said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom that is output on the display unit comprises at least one of the one or more treatment reports.
  • the communications unit may comprise at least one microphone and at least one speaker, and the computation unit may be configured to establish a two-way audio communication channel utilizing the communications unit.
  • the two-way audio communication channel may be established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
  • the communications unit may comprise at least one camera, and the computation unit may be configured to establish a two-way video communication channel utilizing the communications unit and the display unit.
  • the two-way video communication channel may be established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
  • the computation unit may be further configured to monitor a device state of at least one of the plurality of deployable devices, to manage device updates for at least one of the plurality of deployable devices, combinations thereof, etc.
  • the physiologic monitoring kit may further comprise medical equipment utilizable for treating the one or more subjects housed in the at least one compartment.
  • the medical equipment may comprise at least one of one or more clamps, one or more clips, one or more scissors, one or more probes, one or more forceps, one or more towel clips, and one or more suture necessities.
  • a carrying case comprises a computation unit comprising at least one processing device comprising a processor coupled to a memory, a communications unit comprising at least one network interface, a display unit comprising at least one display, a housing comprising at least one compartment, and a power supply unit comprising at least one power supply, the power supply unit being configured to power the computation unit, the communications unit and the display unit.
  • the computation unit is configured to manage pairing of respective ones of a plurality of deployable devices with one or more subjects.
  • the computation unit is also configured to join, via the communications unit, a mesh network for a local monitoring environment wherein at least one of the paired ones of the plurality of deployable devices has been deployed.
  • the computation unit is further configured to obtain, via the mesh network, physiologic monitoring data associated with at least one of the one or more subjects from at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
  • the computation unit is further configured to control output of at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of information generated therefrom on the display unit.
  • the carrying case may further comprise one or more lights, the one or more lights being configured for illuminating at least a portion of the at least one compartment.
  • the power supply unit may be further configured to charge at least one of the plurality of deployable devices.
  • the plurality of deployable devices may comprise one or more gateway devices, one or more sensing devices configured for pairing with the one or more gateway devices, and one or more smart devices.
  • the computation unit may be further configured to utilize the communications unit to establish a data link, distinct from the mesh network, with at least one external system outside the local monitoring environment.
  • the computation unit may be further configured to provide at least a portion of the obtained physiologic monitoring data or at least a portion of the information generated therefrom to the at least one external system via the data link.
  • the carrying case may further comprise a data storage unit comprising one or more storage devices, and the computation unit may be further configured to store at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit.
  • the storage of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit may be performed responsive to the computation unit being unable to establish, via the communications unit, a data link with the at least one external system outside the local monitoring environment.
  • the at least one display of the display unit may comprise a touchscreen display, and the computation unit may be configured to provide, via the touchscreen display, user interface features enabling dynamic selection of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom to output on the display unit.
  • the computation unit may be further configured to generate one or more monitoring or treatment reports for at least one of the one or more subjects based at least in part on the obtained physiologic monitoring data, and wherein said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom that is output on the display unit comprises at least one of the one or more monitoring or treatment reports.
  • the communications unit may comprise at least one microphone and at least one speaker, and the computation unit may be configured to establish a two-way audio communication channel utilizing the communications unit.
  • the two-way audio communication channel may be established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
  • the communications unit may comprise at least one camera, and the computation unit may be configured to establish a two-way video communication channel utilizing the communications unit and the display unit.
  • the two-way video communication channel may be established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
  • the computation unit may be further configured to monitor a device state of at least one of the plurality of deployable devices, to manage device updates for at least one of the plurality of deployable devices, combinations thereof, etc.
  • a method comprises managing, utilizing a computation unit of a carrying case of a physiologic monitoring kit, pairing of respective ones of a plurality of deployable devices of the physiologic monitoring kit with one or more subjects.
  • the method also comprises joining, via a communications unit of the carrying case of the physiologic monitoring kit, a mesh network for a local monitoring environment wherein at least one of the paired ones of the plurality of deployable devices has been deployed.
  • the method further comprises obtaining, via the mesh network, physiologic monitoring data associated with at least one of the one or more subjects from at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
  • the method further comprises controlling output, on a display unit of the carrying case of the physiologic monitoring kit, of at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of information generated therefrom.
  • the method may further comprise establishing, via the communications unit of the carrying case of the physiologic monitoring kit, a data link distinct from the mesh network with at least one external system outside the local monitoring environment.
  • the method may further comprise providing, via the data link, at least a portion of the obtained physiologic monitoring data or at least a portion of the information generated therefrom to the at least one external system.
  • the method may further comprise storing at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in a data storage unit of the carrying case of the physiologic monitoring kit.
  • the storage of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit may be performed responsive to the computation unit of the carrying case of the physiologic monitoring kit being unable to establish, via the communications unit of the carrying case of the physiologic monitoring kit, a data link with the at least one external system outside the local monitoring environment.
  • the method may further comprise establishing, utilizing the communications unit of the carrying case of the physiologic monitoring kit, a two-way audio communication channel with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
  • the method may further comprise establishing, utilizing the communications unit and the display unit of the carrying case of the physiologic monitoring kit, a two-way video communication channel with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
  • a computer program product comprises a non- transitory processor-readable storage medium having stored therein executable program code which, when executed, causes a computation unit of a carrying case of a physiologic monitoring kit to manage pairing of respective ones of a plurality of deployable devices of the physiologic monitoring kit with one or more subjects.
  • the executable program code when executed, also causes the computation unit of the carrying case of the physiologic monitoring kit to join, via a communications unit of the carrying case of the physiologic monitoring kit, a mesh network for a local monitoring environment wherein at least one of the paired ones of the plurality of deployable devices o has been deployed.
  • the executable program code when executed, further causes the computation unit of the carrying case of the physiologic monitoring kit to obtain, via the mesh network, physiologic monitoring data associated with at least one of the one or more subjects from at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
  • the executable program code when executed, further causes the computation unit of the carrying case of the physiologic monitoring kit to control output, on a display unit of the carrying case of the physiologic monitoring kit, of at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of information generated therefrom.
  • the executable program code when executed, may further cause the computation unit of the carrying case of the physiologic monitoring kit to establish, via the communications unit of the carrying case of the physiologic monitoring kit, a data link distinct from the mesh network with at least one external system outside the local monitoring environment.
  • the executable program code when executed, may further cause the computation unit of the carrying case of the physiologic monitoring kit to provide, via the data link, at least a portion of the obtained physiologic monitoring data or at least a portion of the information generated therefrom to the at least one external system.
  • the executable program code when executed, may further cause the computation unit of the carrying case of the physiologic monitoring kit to store at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in a data storage unit of the carrying case of the physiologic monitoring kit.
  • the storage of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit may be performed responsive to the computation unit of the carrying case of the physiologic monitoring kit being unable to establish, via the communications unit of the carrying case of the physiologic monitoring kit, a data link with the at least one external system outside the local monitoring environment.
  • the executable program code when executed, may further cause the computation unit of the carrying case of the physiologic monitoring kit to utilize the communications unit of the carrying case of the physiologic monitoring kit to establish a two-way audio communication channel with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
  • the executable program code when executed, may further cause the computation unit of the carrying case of the physiologic monitoring kit to utilize the communications unit of the carrying case of the physiologic monitoring kit to establish a two-way video communication channel with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
  • illustrative embodiments enable rapid deployment for physiologic monitoring of subjects in various environments, including in austere environments.
  • FIG. 1 illustrates aspects of a modular physiological monitoring system, according to an embodiment of the invention.
  • FIGS. 2A-2D illustrate a modular physiological monitoring system, according to an embodiment of the invention.
  • FIGS. 3A-3F illustrate a wearable sensor system configured for physiologic monitoring of subjects in a local monitoring environment utilizing a rapid deployment carrying case, according to an embodiment of the invention.
  • FIGS. 4 A and 4B illustrate a rapid care delivery deployment kit, according to an embodiment of the invention.
  • FIG. 5 illustrates a table of notional military roles of medical care, according to an embodiment of the invention.
  • FIGS. 6 A and 6B illustrate a local monitoring environment, according to an embodiment of the invention.
  • FIG. 7 illustrates a process flow for utilizing a rapid deployment physiologic monitoring kit, according to an embodiment of the invention.
  • One illustrative, non-limiting objective of this disclosure is to provide systems, devices, methods, and kits for physiologic monitoring of a subject.
  • Another illustrative, nonlimiting objective of this disclosure is to provide systems, devices, and methods for managing networks, including body area networks including different types of devices configured for physiologic monitoring of a subject, including monitoring of contextual and environmental information regarding an environment that the subject is in.
  • Another illustrative, non-limiting objective is to provide a flexible architecture enabling sharing of contextual and environmental information about different types of devices that are part of a body area network associated with a subject.
  • a modular physiological monitoring system in accordance with the present disclosure is configured to monitor one or more physiological and/or physical signals, also referred to herein as physiological parameters, of a subject (e.g., a human subject, a patient, a soldier, an athlete, a trainer, an animal such as equine, canine, porcine, bovine, etc.).
  • the modular physiological 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 physiological monitoring system may also include one or more modules (also referred to as hubs in some illustrative embodiments), 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 physiological and/or physical signals, signals derived therefrom, and/or metrics derived therefrom obtained via the interface with the subject.
  • Each module may include a power source (e.g., a battery, a rechargeable battery, an energy harvesting transducer, 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, etc.), signal conditioning circuitry, communication circuitry, one or more sensors, or the like, configured to generate one or more signals (e.g., physiological and/or physical signals), stimulus, etc.
  • a power source e.g., a battery, a rechargeable battery, an energy harvesting transducer, 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, etc.
  • signal conditioning circuitry e.g., a signal conditioning circuitry, communication circuitry, one or more sensors, or the like, configured to generate one or more signals (e.g
  • 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 a corresponding module.
  • 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 from the skin of the subject may result in a permanent loss in shape of the patch without tearing of the patch.
  • the interconnect may be sufficiently frail such that removal of the patch 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 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 absorption 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.
  • Such a configuration may be advantageous for providing a comfortable wearable physiological 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 set may be configured as a sensing device to monitor one or more local physiological 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.
  • a host device e.g., via a wireless connection, via a body area network connection, or the like
  • Each patch and/or patch-module set 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 and/or other source, the signaling being based on analysis of the physiological and/or physical parameters of the subject measured by the sensing device(s).
  • the patch or patch-module sets are examples of what are more generally referred to herein as “primary” sensing devices, which are advantageously designed as on-body sensing devices with a small form factor as part of the modular monitoring system. While such primary sensing devices may be used to obtain some desired information (e.g., local physiological and/or physical parameters of the attached subject, local environment, combinations thereof, etc.), in some cases it is beneficial to obtain contextual information from other types of sensors which are difficult to integrate into such primary sensing devices designed as on-body sensing devices with small form factors. Such other types of sensors may be integrated into “secondary” or accessory sensing devices that do not have the limitations of the “primary” sensing devices.
  • the primary sensing devices may be designed as on-body sensing devices with a small form factor for comfortable long-term wear by the subject
  • the secondary or accessory sensing devices may have larger form factors to accommodate different types of sensors than the primary sensing devices.
  • the secondary or accessory sensing devices may be incorporated into equipment or gear that is carried by a subject, into one or more wearable computing devices, a carrying case of a rapid care delivery deployment kit, etc.
  • an accessory sensing device is directly attached to the body of the subject.
  • primary sensing devices can be attached or otherwise incorporated in equipment or gear carried by the subject, including but not limited to rapid care delivery deployment kits.
  • the on-body physiological monitoring or other primary sensing devices can benefit from additional contextual and environmental information about the conditions surrounding a subject under study, where the additional contextual and environmental information may be obtained from one or more accessory sensing devices.
  • the primary sensing devices may be used to acquire one or more physiological metrics of the subject such as heart rate, core temperature, respiratory cycle status, etc.
  • physiological metric data may be augmented by contextual or environmental data obtained using primary sensing devices and/or additional external sensing capabilities of accessory sensing devices, where the devices may target exposure of the subject to infectious agents, insolation, etc.
  • This contextualization capability may, under some circumstances, need to be flexible, requiring different sensing modalities at different times with different subjects under study.
  • sensors may not be easily integrated into a single primary (e.g., on-body) sensing device with a small form factor, and thus may need to be externalized into one or more accessory sensing devices that may be placed at different locations relative to the primary sensing devices on the same individual.
  • These various primary and accessory sensing devices may require a dedicated body area network to manage their functions, to enable efficient data sharing among them, and to facilitate contextual analysis of the different data obtained therefrom.
  • the host device may be configured to coordinate information exchange to/from each module and/or patch or other on-body primary sensing device as well as accessory sensing devices that are part of a body area network associated with a subject, and to generate one or more physiological 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 electronic health record or EHR, a social network, an field operational network, etc.), a processor, combinations thereof, or the like.
  • EHR electronic health record
  • a database e.g., as part of a data management center, an electronic health record or EHR, a social network, an field operational network, etc.
  • 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 subject’s equipment or gear, 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.
  • the host device may also be part of a carrying case in a rapid care delivery deployment kit.
  • 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, 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 an interconnect 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 and/or modules on the subject, a wireless gateway or other host device, 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 sets 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.
  • a carrying case of a rapid care delivery deployment kit may provide the time synchronization service for sensing devices and wireless gateways in a local monitoring environment.
  • 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.
  • an event may be one or more temporally-triggered events, one or more spatially-triggered events, one or more occurrence-triggered events, a combination thereof, or the like.
  • 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.
  • a modular physiological monitoring system in accordance with the present disclosure to monitor a subject, to monitor an electrocardiogram (EKG) of a subject, to perform one or more tasks in accordance with the present disclosure, etc.
  • 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. In aspects, 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.
  • the 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 physiological, physical, and/or electrophysiological signals 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 PCB 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.
  • 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.
  • the module may include a sensor and/or microelectronics configured to interface with a sensor included on a corresponding patch.
  • one or more of the sensors may include an electrophysiological 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 electrophysiological 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 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 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 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 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 one or more physiological, physical, and/or electrophysiological signals 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.
  • One or more other ones of the accessories may include an accessory sensing device configured to complement (e.g., provide contextual or environmental information that augments) physiological data obtained from patches and/or patch-module sets providing primary sensing devices.
  • the kit comprises a rapid care delivery deployment kit including a carrying case configured to hold and store a number of sensing devices (e.g., patchmodule sets) as well as wireless gateways.
  • Each wireless gateway may be associated with the carrying case and one user in a group of users that is in a local monitoring environment (e.g., a remote or austere environment with limited connectivity).
  • the sensing devices may be paired with the wireless gateways, and then used for physiologic monitoring of the different users in the group of users.
  • Each of the wireless gateways may manage the sensing devices in a BAN associated with one of the users in the group of users, while the carrying case may manage the group of wireless gateways. This may include coordinating physiologic monitoring among the group of users, storing and/or communicating the physiologic monitoring data associated with different ones of the users in the group of users to an external network, etc.
  • a service system for managing the collection of physiological and/or other data from one or more subjects in a group of subjects, including a subject data management service, configured to generate and/or store subject profiles referencing customer preferences, data sets, and/or monitoring sessions, an automated product delivery service configured to provide the subjects 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 subjects 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 subjects or a responsible entity 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 subjects or a responsible entity 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 physiological 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 physiological and/or electrophysiological signals from each of the devices, obtaining contextual or environmental information from secondary or accessory sensing devices, and analyzing the signals obtained from the primary and secondary sensing 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 one or more devices, patches, modules, and/or systems 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
  • 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 a physiological state of a subject including 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 effect
  • 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 a physiological 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, to compare a pre impact and post impact portion of the HRV signal to determine at least a portion of the effect of the impact, etc.
  • 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, to identify snoring, to identify a sleep apnea event, to identify a bruxism event, to identify a rapid eye movement (REM) sleep state, to identify a sleep walking state, a sleep talking state, a nightmare, or to 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.
  • the modular physiological monitoring system may include 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 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.
  • 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 physiological monitoring system may be used to monitor one or more physiological functions or parameters of a subject, as will be described in further detail below.
  • the sensing devices of the modular physiological 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 physiological 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 aspects are disclosed of a modular physiological monitoring system in accordance with the present disclosure.
  • a subject 1 is shown with a number of patches and/or patch-module sets 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 feedback/user device 147, the patches and/or patch-module sets, and/or the feedback devices 135, 140 may be configured for wireless communication 146, 149 during a monitoring session.
  • a patch-module set 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.), 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 calf muscle 70,
  • 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 wrist 144a, hand 144b or the like may advantageous for interacting with a subject, such as via performing a stress test, performing a thermal stress test, performing a tactile stress test, monitoring outflow, afferent traffic, efferent traffic, etc.
  • a facial muscle e.g., a nasalis, temporalis, zygomaticus minor/major, orbicularis oculi, occipitofrontalis
  • a system in accordance with the present disclosure may be configured to monitor one or more physiological parameters of the subject 1 before, during, and/or after one or more of, a stress test, consumption of a medication, exercise, a drill, a mission, 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.
  • PCT/US2018/062539 published as WO 2018/098073 and titled “Continuous Long-Term Monitoring of a Subject”
  • PCT application serial no. PCT/US2018/043068 published as WO 2019/023055 and titled “Physiological Monitoring Kits”
  • PCT application serial no. PCT/2019/033036 published as WO 2019/226506 and titled “Monitoring Physiological Parameters for Timing Feedback to Enhance Performance of a Subject During an Activity”
  • PCT application serial no. PCT/US2020/031851 published as WO 2020/227514 and titled “Monitoring and Processing Physiological Signals to Detect and Predict Dysfunction of an Anatomical Feature of an Individual”
  • PCT/US2021/033441 published as WO 2021/236948 and titled “Gateway Device Facilitating Collection and Management of Data from a Body Area Network to Study Coordinating System”
  • PCT application serial no. PCT/US2021/028611, published as WO 2021/216847 and titled “Visualizing Physiological Data Obtained from Subjects”
  • PCT application serial no. PCT/US2021/033442, published as WO 2021/236949 and titled “Non-Invasive Detection of Anomalous Physiological Events Indicative of Hypovolemic Shock of a Subject”
  • modular 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 sets 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 sets 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 sets 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 physiological monitoring system may be configured for radio frequency (RF) or other wireless and/or wired connection with one another and/or a host device (e.g., a wireless gateway, a carrying case of a rapid care delivery deployment kit, combinations thereof, etc.).
  • 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 physiological parameters that are obtained using the sensing devices to determine when events related to cardiac and/or other physiological 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 physiological 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 physiological 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 physiological monitoring system.
  • the user of the modular physiological 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, a supervisor, a group leader, a medic, etc., of the subject being monitored and stimulated.
  • the user may also have the option to disconnect or shut down the modular physiological 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 physiological 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 physiological 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 physiological monitoring system may also operate as or provide a type of cardiac “pacemaker” in other embodiments.
  • the modular physiological monitoring system has the potential to reduce the frequency of cardiac events, or to possibly avoid certain cardiac events altogether.
  • a modular physiological 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 physiological 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 physiological 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 effect), 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 physiological 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 physiological 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 physiological monitoring system in that the sensing devices in the modular physiological monitoring system may be used to measure physiological parameters of the subject while the sensing electrodes on the stimulation devices in the modular physiological 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., physiological parameters related to cardiac output).
  • a desired output e.g., physiological 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 physiological monitoring system and/or one or more of the sensing electrodes of the stimulating devices in the modular physiological 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.
  • 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, 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 physiological parameters of the subject utilizing one or more sensing devices.
  • equipment that the subject is wearing or carrying can have one or more stimulating devices incorporated therein and/or thereon.
  • 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 physiological 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 instructing 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-2D show a modular physiological monitoring system 200.
  • the modular physiological monitoring system 200 includes a sensing device 210, an accessory device 215 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 accessory sensing device 215 is mounted on equipment carried by the subject 201, such as a firearm, firearm holster, etc.
  • the hots device 230 may be embodied as a wireless gateway and/or a carrying case of a rapid care delivery deployment kit.
  • 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, the accessory device 215 and the stimulating device 220.
  • FIG. 2A illustrates a modular physiological monitoring system 200 that includes only a single instance of the sensing device 210, the accessory device 215 and the stimulating device 220 for clarity. It is to be appreciated, however, that modular physiological monitoring system 200 may include multiple sensing devices, accessory devices, and/or stimulating devices.
  • FIG. 2A illustrates a modular physiological monitoring system 200 in which the sensing device 210 and the stimulating device 220 are attached to the subject 201 while the accessory device 215 is not 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.
  • accessory devices may alternatively be “on-body” or attached to the subject 201 as described elsewhere herein.
  • sensing device 210 and stimulating device 220 on the subject 201 may vary as described above.
  • the host device 230 (and possibly the accessory device 215) 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, the accessory device 215 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 physiological 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 accessory device 215, the stimulating device 220 and the host device 230.
  • FIG. 2C shows a schematic diagram of aspects of the stimulating device 220 in modular physiological 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, the accessory device 215, and the host device 230.
  • FIG. 2D shows a schematic diagram of aspects of the accessory device 215 in modular physiological monitoring system 200.
  • the accessory device 215 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 accessory device 215 is configured for wireless communication 225 with the sensing device 210, the stimulating device 220, and the 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 set (e.g., via a hub or module of a patch-module set) 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.
  • the PCD may also be part of or provide functionality of an accessory device.
  • the host device 230 provides the PCD.
  • the host device 230 may be embodied as a wireless gateway and/or a carrying case of a rapid care delivery deployment kit.
  • FIGS. 3A-3F show a wearable sensor system 300 configured for monitoring physiologic, location, and contextual and/or environmental data for a plurality of users, and for analyzing such data for use in health monitoring, event detection, etc.
  • the wearable sensor system 300 provides the capability for assessing the condition of the human body of a plurality of users (e.g., including user 336 and a crowd of users 338).
  • the wearable sensor system 300 includes a wearable device 302 that is affixed to user 336, as well as one or more accessory devices 315 having sensors configured for capturing contextual and/or environmental information for the user 336 and/or the crowd of users 338.
  • the accessory devices 315 may, but are not required to be, “off-body” devices relative to the user 336 and/or the crowd of users 338.
  • the accessory devices 315 may comprise, be attached to, or otherwise incorporate within a firearm or other equipment that is carried on or worn by the user 336.
  • the user 336 and the crowd of users 338 are part of a local monitoring environment 301, which may be a remote or austere environment.
  • the local monitoring environment 301 may be configured with rapidly deployable physiologic monitoring capability via a rapid care delivery deployment kit.
  • the rapid care delivery deployment kit provides rapidly deployable physiologic monitoring capability “in a box” via rapid deployment carrying case 390, which is a mobile case that may be brought to the local monitoring environment 301.
  • the rapid deployment carrying case 390 includes a housing storing, among other things, various sensing devices (e.g., wearable device 302 and accessory devices 315) and wireless gateways (e.g., wireless gateway 340).
  • Each of the wireless gateways stored in the rapid deployment carrying case 390 is assumed to be paired with a communications unit of the rapid deployment carrying case 390, and may be dynamically paired or otherwise associated with one of the user 336 or a user in the crowd of users 338.
  • Different ones of the sensing devices stored in the rapid deployment carrying case 390 may be dynamically paired or associated with different ones of the wireless gateways.
  • the given sensing device may be attached to or otherwise placed in or near the given user to perform physiologic, contextual and/or environmental monitoring of the given user.
  • the wireless gateways which are associated with different ones of the user 336 and users in the crowd of users 338, relay physiologic, contextual and/or environmental monitoring data from its associated sensing devices to the rapid deployment carrying case 390 in the local monitoring environment 301.
  • the rapid deployment carrying case 390 may store such data, perform analysis thereof, and relay the data via network 384 to the artificial intelligence (Al) wearable device network 348 and/or one or more third-party networks 368.
  • the rapid deployment carrying case 390 may do so when its communications unit is able to establish connectivity to the network 384 outside the local monitoring environment 301.
  • the local monitoring environment 301 may include, for example, training and operational safety scenarios, natural disasters (e.g., flooding, fires, violent storms, etc.), accident sites (e.g., train accidents, building collapses, boat crashes, etc.), terrorist attacks, etc. which involve the user 336 and the crowd of users 338.
  • natural disasters e.g., flooding, fires, violent storms, etc.
  • accident sites e.g., train accidents, building collapses, boat crashes, etc.
  • terrorist attacks etc. which involve the user 336 and the crowd of users 338.
  • one or more of the user 336 and users in the crowd of users 338 are part of first responder teams, search and rescue teams, etc., which are deployed to the local monitoring environment 301 to respond to these and other scenarios.
  • commercial communication networks may be damaged and/or have limited availability in the local monitoring environment 301.
  • a natural disaster such as a tornado where many people are injured.
  • First responders may enter the affected area (e.g., the local monitoring environment 301) with a rapid care delivery deployment kit including the rapid deployment carrying case 390, and may distribute wireless gateways and sensing devices to the injured persons in the local monitoring environment 301 to monitor the aftermath of the tornado, and locate, stabilize and evacuate survivors. Such actions may be coordinated through physiologic, contextual and/or environmental monitoring data that is collected from the sensing devices and communicated, via the wireless gateways, to the rapid deployment carrying case 390.
  • a rapid care delivery deployment kit including the rapid deployment carrying case 390
  • the rapid care delivery deployment kit may include everything needed to quickly deploy real-time monitoring capabilities to the user 336 and the crowd of users 338 in the local monitoring environment 301 (e.g., an austere environment).
  • the rapid deployment carrying case 390 of the kit is configured to join a mesh network for transferring data from the user 336 and the crowd of users 338 to one or more authorized entities (e.g., leadership, cadre, caregivers, nurses, first responders, etc.).
  • the wireless gateway 340 associated with user 336 and other wireless gateways associated with the crowd of users are configured, in some embodiments, to automatically establish the mesh network.
  • the wireless gateway 340 for example, has an internal processor and works together with other wireless gateways to get data to end users (e.g., smartphones of the end users), and back to network exit points (e.g., smartphones, a computation unit of the rapid deployment carrying case 390, etc.).
  • end users e.g., smartphones of the end users
  • network exit points e.g., smartphones, a computation unit of the rapid deployment carrying case 390, etc.
  • the mesh network may be formed on one or more physical layers, each physical layer comprising a range of frequency bands, upon which data can be transferred.
  • the mesh network may comprise at least one mesh protocol based on a long range evolution schema, an ultrawideband (UWB) mesh protocol, a Bluetooth Low Energy (BLE) mesh protocol, a WiFi mesh protocol, a HaLow mesh protocol, a private 5G mesh protocol, or the like.
  • the mesh network of devices may be configured to use time of flight (TOF), time difference of arrival (TDoA), and phase difference of arrival (PDoA) technologies, or the like to enable extremely accurate (e.g., within a centimeter) distance and location tracking and two- way ranging capabilities between subjects in the network.
  • the smart devices may be equipped with applications (e.g., the Android Tactical Awareness Kit (ATAK), iTAK, Kill Switch, winTAK, or the like) in order to visualize such location-based relationships between the devices.
  • ATAK the Android Tactical Awareness Kit
  • the rapid care delivery deployment kit may include sensing devices (e.g., wearable physiologic sensors such as wearable device 302 and/or accessory devices such as accessory devices 315) for each of the users to be monitored (e.g., the user 336 and the crowd of users 338).
  • the rapid care delivery deployment kit may further include accompanying or integrated communication devices (e.g., PCDs, such as wireless gateway 340) for use in establishing a local network among the user 336, the crowd of users 338 and the rapid deployment carrying case 390.
  • sensing devices e.g., wearable physiologic sensors such as wearable device 302 and/or accessory devices such as accessory devices 315) for each of the users to be monitored (e.g., the user 336 and the crowd of users 338).
  • the rapid care delivery deployment kit may further include accompanying or integrated communication devices (e.g., PCDs, such as wireless gateway 340) for use in establishing a local network among the user 336, the crowd of users 338 and the rapid deployment carrying case 3
  • Each of the PCDs or wireless gateways may manage the BAN associated with a single one of the user 336 or a user in the crowd of users 338, with a local or mesh network being established between the rapid deployment carrying case 390 and the different PCDs or wireless gateways.
  • the rapid deployment carrying case 390 may also include: one or more processing devices or other compute hardware for generating or deriving reports or metrics from the physiologic, contextual and/or environmental data associated with the user 336 and the crowd of users 338; one or more visualization devices (e.g., a touchscreen display or other type of display unit) for supervisors and/or caregivers to view the physiologic, contextual and/or environmental data associated with the user 336 and the crowd of users 338 (or reports or metrics which are derived or generated therefrom), to manage or organize the sensing devices and/or wireless gateways, to provide video conferencing capability, etc.; one or more data storage devices for storing the physiologic, contextual and/or environmental data associated with the user 336 and the crowd of users 338 (or reports or metrics which are derived or generated therefrom); communication hardware for offloading the physiologic, contextual and/or environmental data (or metrics or reports which are generated or derived therefrom) to the Al wearable
  • the communication hardware provides a long-range communication system to provide a data link between the local monitoring environment 301 and a remote site (e.g., the Al wearable device network 348, the third-party networks 368, etc.).
  • the remote site may include a hospital, a role 2 facility, a role 1 facility, a fire station, a command center, etc.
  • the rapid deployment carrying case 390 may, in some cases, include sensing devices embodied as patch-module sets, wireless gateways, smart devices (e.g., smartphones, tablets, etc.), one or more displays, compute hardware, a radio system or other communication hardware, a mass storage drive or other data storage devices, etc.
  • 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.
  • the local monitoring environment 301 is connected to the network 384 via the rapid deployment carrying case 390.
  • the Al wearable device network 348 and a verification entity 386 coupled to the third-party networks 368.
  • FIGS. 3B-3F Detailed views of the wearable device 302, wireless gateway 340, Al
  • the wearable device 302 is implemented using one or more patch-module sets as described above with respect to FIGS. 1 and 2A-2C.
  • the patch-module sets 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.
  • Various other types of wearable technology may be used to provide the wearable device 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 microcontrollers) 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, via the wireless gateway 340 and the rapid deployment carrying case 390.
  • the wearable sensor system 300 in some embodiments, is user-friendly, hypoallergenic, unobtrusive, and cost-effective.
  • 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 or in other remote environments (e.g., the local monitoring environment 301) outside health care facilities.
  • the wearable device 302 is designed to monitor the cardiopulmonary state of a subject (e.g., 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 a reusable sensing unit 314 shown in FIG. 3B.
  • the patch-module sets 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 UWB communication unit 332, contextual analysis module 334 and sensor data reconstruction module 339.
  • 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.
  • USB universal serial bus
  • 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.), cloudbased processing units (e.g., Amazon Web Services (AWS) processing units), edge computing systems, embedded systems (e.g., Nvidia® JetsonTM), etc.
  • general-purpose processors e.g., Intel® or Advanced Micro Devices (AMD)® microprocessors
  • special-purpose processors e.g., digital signal processors or Xilink® system on chip (SOC) field programmable gate array (FPGA) processors, application-specific integrated circuits (
  • 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 contextual analysis module 334 and the sensor data reconstruction module 339 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 contextual analysis module 334 and/or the sensor data reconstruction module 339 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 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.
  • the patch or disposable sampling unit 312 may be disposed of after the monitoring duration has ended.
  • One or more of the sensors 316-329 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, transce
  • one or more of the sensors 316-329 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 316-329 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 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.
  • 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 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 contextual analysis module 334 is configured to execute various functionality for combining sensor data from the sensing unit 314 (e.g., physiologic monitoring data for the user 336) along with sensor data from the accessory devices 315 (e.g., contextual and/or environmental information associated with the user 336 and/or the crowd of users 338) for higher-level analysis.
  • sensor data from the sensing unit 314 e.g., physiologic monitoring data for the user 336
  • accessory devices 315 e.g., contextual and/or environmental information associated with the user 336 and/or the crowd of users 33
  • the sensor data reconstruction module 339 is configured to execute various functionality for reconstructing sensor data from the sensing unit 314 and/or the accessory devices 315 (e.g., to correct for missing, erroneous, corrupt or contaminated data, to account for sensors of the sensing unit 314 and/or the accessory devices 315 which have been destroyed, disabled or are otherwise unable to produce sensor data, to account for sensors of the sensing unit 314 and/or the accessory devices 315 which are inherently limited in what data the can produce and convey, etc.).
  • various functionality for reconstructing sensor data from the sensing unit 314 and/or the accessory devices 315 e.g., to correct for missing, erroneous, corrupt or contaminated data, to account for sensors of the sensing unit 314 and/or the accessory devices 315 which have been destroyed, disabled or are otherwise unable to produce sensor data, to account for sensors of the sensing unit 314 and/or the accessory devices 315 which are inherently limited in what data the can produce and convey, etc.
  • the user 336 may be a human or animal to which the wearable device 302 is attached.
  • Sensor data and localization data collected by the wearable device 302, along with contextual and/or environmental data collected from the accessory devices 315, may be provided to Al wearable device network 348 for analysis, with portions or such analysis being provided to one or more of the third-party networks 368 for various purposes.
  • Communication of the sensor and localization data from the wearable device 302, as well as communication of the contextual and/or environmental data from the accessory devices 315, to the Al wearable device network 348 may take place via the 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 using the rapid deployment carrying case 390.
  • 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 316-329 of the wearable device 302.
  • the user profile 344 may include information such as a name (e.g., first, last and middle name), biological sex, 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 344 may also include known diseases and disorders (e.g., asthma, allergies, current medications, family medical history, other medical data, etc.), where such information may include Protected Health Information (PHI) regulated by American Health Insurance Portability and Accountability Act (HIPAA) or other applicable rules and regulations.
  • 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
  • the user profile 344 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 344 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, as well as contextual and/or environmental data obtained from the accessory devices 315, utilizing communications unit 346, which may comprise any type of transceiver for coupling the wireless gateway 340 to the rapid deployment carrying case 390 (or, in some cases, to another device such as a smartphone housed in the rapid deployment carrying case 390 or which is associated with one or more of the user 336 and the crowd of users 338, or directly 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 (e.g., utilizing the rapid deployment carrying case 390), 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 UWB, NFC, WiFi, Bluetooth, BLE, IR, modem, cellular, ZigBee, BAN, etc.
  • the wireless gateway 340 may also be provisioned with contextual analysis module 347 and sensor data reconstruction module 349, which provide functionality similar to that of the contextual analysis module 334 and the sensor data reconstruction module 339, respectively.
  • 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 in some embodiments, 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 uniquely paired with the user 336, and which allows rapid onboarding of wearable devices such as wearable device 302 to a local BAN associated with the user 336.
  • the wireless gateway 340 is also assumed to be paired with the rapid deployment carrying case 390, and is configured for communication therewith (e.g., to act as a bridge between the BAN of the user 336 and a mesh network formed by the wireless gateway 340 and other wireless gateways associated with one or more of the users in the crowd of users 338.
  • Such functionality may also include receiving the sensor data and the localization data from the wearable device 302 and the contextual and/or environmental data from the accessory devices 315 via the communications unit 346, and possibly performing a preliminary analysis of the sensor data, the localization data and the contextual and/or environmental 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 and the accessory device module 343 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. In other embodiments, the wearable device 302 functions as a pass-through entity and does not perform such preliminary analysis.
  • the wearable device module 342 and the accessory device module 343 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 from the Al wearable device network 348, etc. At least a portion of the received information is based on analysis of the sensor data, the localization data, the user profile 344, the contextual and/or environmental data, or information derived therefrom previously provided by the wireless gateway 340 to the rapid deployment carrying case 390 and/or 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, one or more of the accessory devices 315, or another type of local or remote indicator device.
  • GUI graphical user interface
  • the wearable device module 342 and/or the accessory device module 343 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 utilizing the wearable device 302 and/or one or more of the accessory devices 315 or other devices.
  • the notification settings may specify the types of indicator devices that are part of or otherwise accessible to the wearable device 302 and/or the accessory devices 315 for delivering notifications to the user 336 (or to a doctor, nurse, physical therapist, medical assistant, caregiver, 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 and/or the accessory devices 315 associated with user 336. For example, 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, such as one or more of the accessory devices 315.
  • 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. It should be understood that 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.
  • the term “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, first responder, squad leader, 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, first responder, squad leader, 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, first responder, squad leader, 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 and/or accessory devices to the rapid deployment carrying case 390 and/or the Al wearable device network 348, possibly via respective wireless gateways.
  • the wearable devices, accessory 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, the accessory devices 315, and the wireless gateway 340 associated with the user 336.
  • the wearable device 302 may be configured with multiple different types of sensors 316-329, it is generally not possible to configure a wearable device with every possible sensor that may be needed in different scenarios.
  • wearable devices are advantageously designed for comfortable wear and use, and thus may require a small form factor which cannot accommodate the possible range of sensors and sensor types which may be needed in different scenarios.
  • some types of sensors are large, heavy and/or expensive, and thus are not conducive to being incorporated as part of a wearable device. Nonetheless, different tasks may benefit from the use of contextual and/or environmental information which may be provided using sensor types that are not available in the wearable device 302.
  • the wearable device 302 may not be configured with dosimeter sensors, as this may not be practical (e.g., due to the size, power, material and other requirements) or such a potential use case is not expected to come up very often.
  • accessory sensing devices 315 that include dosimeter sensors may be leveraged to provide such information which is used for contextual analysis (e.g., implemented by the contextual analysis module 334 on the wearable device 302, on the contextual analysis module 347 of the wireless gateway 340, on a contextual analysis module 367 of the Al wearable device network 348, on contextual analysis modules implemented by the accessory devices 315 and/or one or more of the third-party networks 368, etc.).
  • contextual analysis e.g., implemented by the contextual analysis module 334 on the wearable device 302, on the contextual analysis module 347 of the wireless gateway 340, on a contextual analysis module 367 of the Al wearable device network 348, on contextual analysis modules implemented by the accessory devices 315 and/or one or more of the third-party networks 368, etc.
  • the accessory sensing devices 315 may also or alternatively be used to determine the user 336’ s microenvironmental exposure to light, noise, temperature, humidity, pressure, etc. These and other factors can influence different aspects of the microenvironment of the user 336 which can be correlated with physiologic data obtained from the user 336 via the sensing unit 314 of the wearable device 302. This may include use cases such as impact/fall detection, detecting fatigue of the user 336, etc. Another use case is in determining a “wet-bulb” temperature of the user 336. The wet-bulb temperature of the user 336, which may be determined from microenvironmental monitoring of information such as light, temperature, humidity and pressure, can be correlated with measured physiologic data to determine harmful and potentially life-threatening conditions.
  • the microenvironmental information and physiologic monitoring data may be used for various types of contextual analysis, where the microenvironmental information and physiologic monitoring data are correlated with knowledge of what the user 336 is doing (e.g., whether the user 336 is awake or asleep, a physical workload or profile of the user 336, etc.).
  • Noise information in some cases, may be used for contextual analysis of the activity of multiple users (e.g., the user 336 and one or more of the users in the crowd of users 338) to provide spatial reference information (e.g., detecting where shots/blasts come from, where drones or vehicles are traveling, etc.).
  • the accessory sensing devices 315 are leveraged to provide contextual and/or environmental information which is difficult, not possible or not practical to obtain utilizing the wearable device 302 alone. This may be due to the contextual and/or environmental information only being needed in limited use cases, such that the cost of implementing the required sensor types within the wearable device 302 is not practical or cost- effective.
  • the sensor types of the accessory devices 315 which are leveraged to obtain contextual and/or environmental information are not limited solely to sensor types which are difficult to implement within the small form factor or other constraints of the wearable device 302 (e.g., comfortable long-term wear by the user 336, cost, etc.).
  • the contextual and/or environmental information may be used in sensor data reconstruction algorithms implemented by one or more of the sensor data reconstruction module 339, the sensor data reconstruction module 349, and/or sensor data reconstruction module 369.
  • the Al wearable device network 348 is configured to receive data (e.g., sensor data and localization data from the wearable device 302, contextual and/or environmental data from the accessory devices 315, user profile 344, preliminary analysis of the sensor, localization and contextual and/or environmental data, etc.) from the rapid deployment carrying case 390 (or potentially, from the wireless gateway 340 associated with the user 336 or other wireless gateways associated with users in 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, occurrence of events, event classification (e.g., including detection of firearm discharges), 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 military or other security module 365, a contextual analysis module 367, and a sensor data reconstruction module 369.
  • the contextual analysis module 367 and the sensor data reconstruction module 369 are configured to provide functionality similar to that of the contextual analysis module 334 and the sensor data reconstruction module 339, respectively.
  • 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 (e.g., information about the user 336 and crowd of users 338), information relating to diseases including epidemics or pandemics, information related to firearm discharges and the context in which such firearm discharges occurred, etc.
  • patient conditions e.g., information about the user 336 and crowd of users 338
  • information relating to diseases including epidemics or pandemics e.g., information about the user 336 and crowd of users 338
  • information relating to diseases including epidemics or pandemics e.g., information about the user 336 and crowd of users 338
  • information relating to diseases including epidemics or pandemics relating to firearm discharges and the context in which such firearm discharges occurred, etc.
  • 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 3
  • the third-party networks 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, one or more military or other security networks 383, 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.
  • 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 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 be utilized for monitoring user 336 and the crowd of users 338 before, during and after detection of firearm discharges. Such information, for example, may be provided to various ones of the third-party networks 368, such as the first responder networks 370, the military or other security networks 383, etc.
  • the location tracking module 356 is configured to track the location of user 336 and the crowd of users 338, such as 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, in some embodiments, 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), a geographic location or region associated with a natural disaster, a geographic location or region associated with exposure to radiation, toxins or other potentially harmful environmental conditions, etc.
  • 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 may be modified based on location of the user 336 and crowd of users 338. For example, the threshold for detecting a symptom (e.g., shortness of breath) may be lowered if the user 336 or crowd of users 338 are in high-risk locations for contracting an infectious disease.
  • the location tracking module 356 may also be configured to track the locations of the user 336 and the crowd of users 338 before, during and after detection of firearm discharges. The tracked location may be provided to various ones of the third-party networks 368, such as the first responder networks 370, the military or other security networks 383, etc.
  • 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 (e.g., associated with a pandemic or other outbreak of a disease, associated with exposure to radiation, toxins or other potentially harmful environmental conditions, etc.).
  • 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 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.
  • pandemic response module 352 can further leverage the contextual and/or environmental data obtained from the accessory devices 315 in performing their various functionality using the contextual analysis module 367 and/or using sensor data reconstructed using the sensor data reconstruction module 369.
  • FIG. 3F shows a detailed view of the rapid deployment carrying case 390, which includes a computation unit 391 implementing wearable device management module 392, wireless gateway management module 393, network management module 394, and local monitoring and analysis module 395, a data storage unit 396, a communications unit 397, a power supply 398, and a display 399.
  • the computation unit 391 may comprise at least one processing device which, together with the data storage unit 396, provides computational and data storage capability for the rapid deployment carrying case 390.
  • the computation unit 39 provides an onboard computational system that can offload data (e.g., collected from the user 336 and the crowd of users 338 using wearable devices and/or accessory devices), store data locally on the data storage unit 396, compute metrics and/or generate monitoring and treatment reports utilizing the local monitoring and analysis module 395, etc.
  • the computation unit 391, in some embodiments, is configured to utilize the local monitoring and analysis module 395 to run a gamut of algorithms, to offload a combination of physiologic data from monitored subjects (e.g., the user 336 and crowd of users 338).
  • the computation unit 39 may utilize the local monitoring and analysis module 395 to monitor identified tasks performed by nurses, doctors, caregivers or other support staff (e.g., via one or more applications on connected smart devices) in order to document what was performed for each of the monitored subjects, and to make that available for downstream review, to store in patient or subject records, etc.
  • the local monitoring and analysis module 395 may utilize the local monitoring and analysis module 395 to monitor identified tasks performed by nurses, doctors, caregivers or other support staff (e.g., via one or more applications on connected smart devices) in order to document what was performed for each of the monitored subjects, and to make that available for downstream review, to store in patient or subject records, etc.
  • this includes displaying computed metrics and/or monitoring and treatment reports which are generated by the local monitoring and analysis module 395, in addition to or in place of the real-time or near realtime waveforms being captured by the wearable devices and/or accessory devices associated with the one or more selected users.
  • the display 399 may be a touchscreen display, or the rapid deployment carrying case 390 may otherwise include user interface features (e.g., buttons, a keyboard, a mouse, etc.) which enable an operator to switch the selected one or more users, to switch what information is displayed for the selected one or more users.
  • Such user interface features may also enable an operator to initiate a videoconference, a phone call or other communication link with the selected one or more users (e.g., via microphones, speakers, and/or displays of smartphones or other devices carried by the selected one or more users, via microphones, speakers and/or displays which are integrated with the wireless gateways and/or one or more sensing devices or indicator devices associated with the selected one or more users, etc.).
  • the communications unit 397 is configured to provide various communications functionality for the rapid deployment carrying case 390.
  • the communications unit 397 includes one or more Universal Serial Bus (USB) ports, WiFi, Bluetooth, NFC or other communication capability to offload data from wearable devices and or wireless gateways which are paired with the rapid deployment carrying case 390 to the data storage unit 396.
  • the communications unit 397 may also include radio systems for long-range communication with remote medical facilities or other systems or devices (e.g., the Al wearable device network 348 and/or the third-party networks 368 via network 384) to offload data from the data storage unit 396. Such radio systems for long-range communication may also be used for receiving data from the remote medical facilities or other systems or devices.
  • the communications unit 397 may also or alternatively facilitate visual and/or audio 2-way communications between the rapid deployment carrying case 390 and other devices (e.g., one or more wearable devices and/or wireless gateways which are paired with the rapid deployment carrying case 390). This may include multi-user simultaneous communication.
  • the communications unit 397 provides a video camera and/or one or more microphones and speakers for sending video and/or audio to local and remote users.
  • the communications unit 397 may further provide for connection to any desired communication network (e.g., network 384) for data transmission.
  • the network management module 394 of the computation unit 391 may control the communications unit 397.
  • the computation unit 391 further provides fleet management functionality via the wearable device management module 392 and the wireless gateway management module 393.
  • the wearable device management module 392 provides functionality for checking the status of wearable devices which are paired or otherwise associated with (e.g., which have been deployed from) the rapid deployment carrying case 390, while the wireless gateway management module 393 provides functionality for checking the status of wireless gateways which are paired or otherwise associated with (e.g., which have been deployed from) the rapid deployment carrying case 390.
  • the wearable device management module 392 and the wireless gateway management module 393 may also provide functionality for managing device updates for such wearable devices and wireless gateways which are paired or otherwise associated with the rapid deployment carrying case 390.
  • the power supply 398 comprises one or more batteries, inverters or other power supply hardware for powering the computation unit 391, the data storage unit 396, the communications unit 397 and the display 399.
  • the power supply 398 may also be used for charging wearable devices and/or wireless gateways, to maintain these and other devices in a state of readiness for when they are deployed for use by the user 336 and the crowd of users 338 in the local monitoring environment 301.
  • the power supply 398 may also comprise lighting functionality, and provide power for one or more lights such as hand-held work lights.
  • the rapid deployment carrying case 390 may comprise a housing with various compartments for carrying and displaying various equipment, including but not limited to wearable devices including disposable sampling units and reusable sensing units such as patches and hubs/modules, wireless gateways, other devices for handling emergent and non-emergent medical problems, etc.
  • wearable devices including disposable sampling units and reusable sensing units such as patches and hubs/modules, wireless gateways, other devices for handling emergent and non-emergent medical problems, etc.
  • Such other devices may include, for example, hand tools such as clamps, clips, scissors, probes, forceps, towel clips, suture necessities, etc.
  • FIGS. 4 A and 4B show a rapid care delivery deployment kit, including a rapid deployment carrying case 400.
  • FIGS. 4A and 4B show different isometric views of the rapid deployment carrying case 400 with a top lid open.
  • the rapid deployment carrying case 400 includes a housing with a number of compartments. In a first compartment in the top lid of the housing of the rapid deployment carrying case 400, a plurality of hubs 405 are mounted on respective hub mounts. In a second compartment of the housing of the rapid deployment carrying case 400, a plurality of wireless gateways 410 are mounted in respective gateway mounts.
  • the housing of the rapid deployment carrying case 400 also includes a power supply and computer 415 mounted along an edge of the second compartment on one side of the housing.
  • a touchscreen display 420 is mounted to a top of the power supply and computer 415.
  • the power supply and computer 415 may include one or more batteries and inverters for a power system powering the computer, communications hardware included in the computer, the touchscreen display 420, charging the hubs 405 and/or wireless gateways 410, etc.
  • a number of smart devices 425 e.g., smartphones
  • the rapid deployment carrying case 400 also includes wheels 430 and a handle 435, which facilitates movement of the rapid deployment carrying case 400 in a manner similar to that of a travel suitcase.
  • FIG. 4A further shows an accessory bag 440 which may be stored in the second compartment of the housing of the rapid deployment carrying case 400.
  • the accessory bag 440 may be one of multiple accessory bags which are stored in the second compartment of the housing of the rapid deployment carrying case 400.
  • the accessory bag 440 may store various items, such as patches, patient prep supplies, cleaning supplies, etc.
  • the hubs 405 and gateways 410 may be combined (e.g., a single device may provide the functionality of a hub and a gateway).
  • one or more of the gateways 410 may include computational resources, memory, sensors, a plurality of radios (e.g., short and long-range radios), etc.
  • the hubs 405 are configured for placement on a subject.
  • Each of the hubs or modules 405 includes one or more sensors configured for performing various functionality.
  • the sensors may include audio channels for communication (which may also or alternatively include speakers or other audio channels on the wireless gateways 410) and physiological monitoring sensors (e.g., for monitoring vitals such as heart rate, respiration, ECG, temperature, limb tissue perfusion, end-tidal carbon dioxide (ETCO2), blood pressure including arterial, central or other blood pressures, blood oxygenation saturation (SpO2), EEG, alertable metrics such as shock, bleeding, low blood oxygen levels, low temperature, cardiac arrythmias, respiratory changes, cardiac arrest, seizures, etc.).
  • vitals such as heart rate, respiration, ECG, temperature, limb tissue perfusion, end-tidal carbon dioxide (ETCO2), blood pressure including arterial, central or other blood pressures, blood oxygenation saturation (SpO2), EEG, alertable metrics such as shock, bleeding, low blood oxygen levels, low temperature, cardiac ar
  • the rapid deployment carrying case 400 has a housing with a top lid that is hinged to optimize display of the contents thereof.
  • the rapid deployment carrying case 400 provides various functionality, including carrying and holding the hubs 405 and wireless gateways 410 which simplifies deployment of such devices in a local monitoring environment.
  • the housing of the rapid deployment carrying case 400 may include a ballistic covering with interior padding and various straps to prevent damage if the rapid deployment carrying case 400 is dropped or subject to trauma.
  • the rapid deployment carrying case 400 may include additional sensors (e.g., ETCO2, blood pressure, SpO2, EEG, etc.).
  • the power supply and computer 415 of the rapid deployment carrying case 400 is able to encode any signal (e.g., obtained from paired ones of the hubs 405 and/or wireless gateways 410) for distant transmission, for display on the integrated touchscreen display 420 or another compatible monitor or other computing device such as one or more of the smartphones 425.
  • the touchscreen display 420 may include an LCD or other screen which is programmable by a user for optimization, and which may display waveforms (e.g., switchable across any or all signals captured from the hubs 405 and/or wireless gateways 410, numerical analysis, etc.).
  • the power supply and computer 415 may also include communications hardware, such as a speaker/microphone for voice over IP (VOIP) or other audio 2-way communications enabling multi-user simultaneous conversation.
  • VOIP voice over IP
  • the communications hardware may further comprise a video camera for sending video or still frames to and from local and remotely connected users.
  • the communications hardware is also configured for enabling connection to various different types of communication networks for transmission of data from the hubs 405 and/or wireless gateways 410 to external networks.
  • Such data may include any encoded signals for distant transmission to external networks for further analysis, for display on compatible monitors or displays, etc.
  • Such encoded signals may communicate various status or state of subjects, including but not limited to: bleeding that will not stop; breathing problems (e.g., difficulty breathing, shortness of breath, etc.); changes in mental status (e.g., unusual behavior, confusion, difficulty arousing, etc.); chest pain or discomfort lasting for at least a designated threshold length of time (e.g., two minutes or more); choking; coughing up or vomiting blood; weak or ineffective coughing; fainting or loss of consciousness; feeling of committing suicide or murder; head or spine injury; severe or persistent vomiting; sudden injury due to a motor vehicle accident, burns or smoke inhalation, near drowning, a deep or large wound, or other injuries; sudden, severe pain anywhere in the body; sudden dizziness, weakness, or change in vision; swallowing a poisonous substance; severe abdominal pain or pressure; unusual headache; inability to speak; swelling of the face, eyes, or tongue; bluish skin color (e.g., cyanosis).
  • breathing problems e.g., difficulty breathing, short
  • the rapid deployment carrying case 400 includes a compartment for carrying and displaying medical equipment for all desired emergent and non-emergent medical problems.
  • the medical equipment may include, for example, hand tools such as clamps, clips, scissors, probes, forceps, towel clips, suture necessities, etc. housed in one or more instances of the accessory bag 440.
  • the rapid deployment carrying case 400 may also include miscellaneous storage content (e.g., for magnifying glasses, dressings, disinfectants, etc., which may be held in one or more instances of the accessory bag 440 or various sub-compartments of a housing of the rapid deployment carrying case 400.
  • the rapid deployment carrying case 400 includes medical equipment for providing therapeutic capabilities (e.g., via the hub 405 or other devices). Such therapeutic capabilities may include defibrillation/cardioversion (e.g., synchronized or unsynchronized), pacing (e.g., transcutaneous/transvascular, multi-mode), etc.
  • Rapid care delivery deployment kits may provide systems which are useful for any role in the care pathway.
  • FIG. 5 shows a table 500 illustrating different notional United States Military Roles of medical care across different armed services branches. Devices in rapid care delivery deployment kits (e.g., sensing devices, wireless gateways, rapid deployment carrying case, etc.) can be handed off seamlessly between roles and networks.
  • One of more devices in a rapid care delivery deployment kit may allow for tracking between facilities or monitoring sites, for planning purposes with in-route patients. This allows for seamless management of subjects through the different medical care roles, and allows surgical teams and other downstream roles to plan for incoming subjects.
  • the devices in a rapid care delivery deployment kit are configured to retain subject records, so data is always available with the subject regardless of whether a long-range network is available or not.
  • the devices in a rapid care delivery deployment kit may automatically integrate with other medical care applications and systems, such as Battlefield assisted trauma distributed observation kit (BATDOK), MedHub, Interoperable Medical Automated Systems (iMAS), etc.
  • BATDOK Battlefield assisted trauma distributed observation kit
  • MedHub MedHub
  • iMAS Interoperable Medical Automated Systems
  • FIGS. 6 A and 6B show a monitoring environment 600 including subjects 601-1 through 601-11 (collectively, subjects 601) each associated with one or more wearable devices 610-1 through 610-11 (collectively, wearable devices 610) and a wireless gateway 612-1 through 612-11 (collectively, wireless gateway 612).
  • the monitoring environment 600 also includes a standalone access point 613 (e.g., which may be embodied as a rapid carrying case of a rapid care delivery deployment kit).
  • the wireless gateways 612 and the standalone access point 613 are used to establish a mesh network among the subjects 601, and provide connectivity in this example to a third-party network 650 (e.g., a government network or another type of third-party network) and an Al wearable device network 655 (e.g., the Al wearable device network 348).
  • the mesh network allows for providing data about one or more of the subjects 601 to medics, nurses, surgeons, other support staff, etc. associated with one or both of the third-party network 650 and the Al wearable device network 655.
  • the mesh network illustratively has full duplex capability so that the third-party network 650 and/or the Al wearable device network 655 can communicate with any of the subjects 601.
  • the standalone access point 613 provides a gateway mesh which can be used for ones of the subjects 601 which otherwise do not have a good connection to other nodes in the mesh network and which have no, poor or limited wide area network (WAN) connectivity to the third-party network 650 and/or the Al wearable device network 655.
  • the gateway mesh may also be used to establish and track locations of the subjects 601, so that first responders or other support staff can move very quickly to ones of the subjects 601 in need.
  • injured ones of the subjects 601 may be tagged for monitoring, and the standalone access point 613 and/or one or more of the wireless gateways 612 provide communications functionality and location tracking for rapid recovery and extraction of the injured ones of the subjects 601.
  • a facility use case may be used to track the locations of subjects within a facility (e.g., a data center, a factory, an office complex, etc.).
  • an operational or training communications use case may involve a group of subjects (e.g., soldiers) which are performing training exercises, combat drills, etc.
  • the mesh network includes a number of different network types.
  • Each of the subjects 601 has its own BAN connection between that subject’s wearable devices 610 and that subject’s one of the wireless gateways 612.
  • the BAN connection may, comprise, for example, a Bluetooth Low Energy (BLE) connection, an Ultrawideband (UWB) connection, etc.
  • BLE Bluetooth Low Energy
  • UWB Ultrawideband
  • the wireless gateways 612 may offload data captured by the wearable devices 610, or reports and/or metrics generated or derived therefrom to the third-party network 650 and/or the Al wearable device network 655.
  • the wireless gateways 612 in some embodiments, store such data until a connection may be established with a mesh WAN.
  • the mesh WAN comprises any combination of Lora, UWB, BLE and WiFi mesh network connections.
  • the mesh WAN may be established between any of the subjects 601 which are within range of one another, regardless of whether such subjects 601 have poor or good cellular connectivity to a cellular WAN which interconnects to the third-party network 650 and/or the Al wearable device network 655.
  • a cellular WAN which interconnects to the third-party network 650 and/or the Al wearable device network 655.
  • Ones of the subjects 601 whose associated wireless gateways 612 having good cellular connectivity to the cellular WAN e.g., a Long Term Evolution (LTE) cellular network, a 5G network, etc.
  • LTE Long Term Evolution
  • the wireless gateways 612-1, 612-4, 612-5, 612-7 and 612-8 associated with the subjects 601-1, 601-4, 601- 5, 601-7 and 601-8 have good cellular connectivity and are interconnected via the cellular WAN to one or both of the third-party network 650 and the Al wearable device network 655.
  • the wireless gateways 612-2, 612-3, 612-6, 612-9, 612-10 and 612-11 associated with the subjects 601-2, 601-3, 601-6, 601-9, 601-10 and 601-11 have poor cellular connectivity and are not connected to the cellular WAN.
  • the wireless gateways 612-2, 612-3, 612-6, 612-9, 612-10 and 612-11 share data via the mesh WAN to other ones of the wireless gateways 612-1, 612-4, 612-5, 612-7 and 612-8 and/or the standalone access point 613 which do have good cellular connectivity and are connected to the cellular WAN.
  • An exemplary process 700 for utilizing a rapid care delivery deployment physiologic monitoring kit will now be described with reference to the flow diagram of FIG. 6. It should be understood, however, that this particular process is only an example and that other types of processes for utilizing rapid care delivery deployment physiologic monitoring kits may be used in other embodiments as described elsewhere herein.
  • the process 700 includes steps 702 through 708.
  • the process 700 may be performed, for example by a computation unit of a carrying case of a physiologic monitoring kit.
  • step 702 pairing of respective ones of a plurality of deployable devices of a physiologic monitoring kit with one or more subjects is managed.
  • the deployable devices may comprise, for example, sensing devices, gateway devices, smart devices, etc.
  • a single device may provide the functionality of a sensing device and a gateway device, or any combination of sensing, gateway and smart devices.
  • the gateway devices may be paired with the subjects, and the sensing devices may be paired with ones of the gateway devices.
  • At least a given one of the sensing devices may comprise a reusable component and a disposable component, wherein at least one compartment of a housing of the carrying case of the physiologic monitoring kit comprising a first compartment comprising at least one mount for attachment of the reusable component and a second compartment for storage of the disposable component.
  • ones of the deployable devices which are smart devices (e.g., smartphones) may be used to assist in assigning and pairing the deployable devices to subjects in step 702.
  • the pairing of step 702 may utilize Near Field Communication (NFC)-based pairing, where ones of the deployable devices (e.g., gateway devices) pair with an NFC identifier (ID) on each subject.
  • NFC ID for a subject may be embodied as or integrated in a dog-tag, a wristband, etc.
  • NFC-based tap pairing of gateway devices to smart devices is used, so that a nurse, doctor, caregiver or other support staff can just “tap” a gateway device with his or her smart device (e.g., smartphone), and patient/subject data is sent from the gateway device to the smart device thus enabling that nurse, doctor, caregiver or other support staff to work on a patient or subject associated with the gateway device.
  • the patient/subject data on one or both of the smart device and the gateway device may be updated with a record of actions taken by the nurse, doctor, caregiver or other support staff.
  • This record of actions which may be entered via one or more applications running on the smart device, may be transferred to the gateway device and stored therein and may be accessed by other users when the patient/subject is moved onward in a process.
  • a mesh network for a local monitoring environment wherein at least one of the paired ones of the plurality of deployable devices of the physiologic monitoring kit has been deployed is joined via a communications unit of the carrying case of the physiologic monitoring kit.
  • the deployable devices which have been deployed in the local monitoring environment may automatically establish the mesh network, and the carrying case of the physiologic monitoring kit may join the mesh network.
  • the carrying case of the physiologic monitoring kit provides a network exit point (e.g., to an external system outside the local monitoring environment) for data that is communicated within the mesh network.
  • physiologic monitoring data associated with at least one of the one or more subjects is obtained via the mesh network from at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
  • the mesh network may be formed on one or more physical layers, each physical layer comprising a range of frequency bands, upon which data can be transferred.
  • the mesh network may comprise at least one mesh protocol based on a long range evolution schema, an ultrawideband (UWB) mesh protocol, a Bluetooth Low Energy (BLE) mesh protocol, a WiFi mesh protocol, a HaLow mesh protocol, a private 5G mesh protocol, or the like.
  • UWB ultrawideband
  • BLE Bluetooth Low Energy
  • the mesh network of devices may be configured to use time of flight (TOF), time difference of arrival (TDoA), and phase difference of arrival (PDoA) technologies, or the like to enable extremely accurate (e.g., within a centimeter) distance and location tracking and two-way ranging capabilities between subjects in the network.
  • the smart devices may be equipped with applications (e.g., the Android Tactical Awareness Kit (ATAK), iTAK, Kill Switch, winTAK, or the like) in order to visualize such location-based relationships between the devices.
  • the computation unit of the carrying case may be further configured to utilize the communications unit to establish a data link, distinct from the mesh network, with at least one external system outside the local monitoring environment.
  • the at least one external system may comprise a remote medical facility.
  • the data link may comprise a cellular network connection, the cellular network connection comprising at least one of a very high frequency (VHF), ultra high frequency (UHF) long-range radio connection, a tactical radio network connection, a Long- Term Evolution (LTE) cellular wide area network (WAN), and a 5G cellular WAN.
  • VHF very high frequency
  • UHF ultra high frequency
  • LTE Long- Term Evolution
  • WAN wide area network
  • 5G cellular WAN 5G cellular WAN.
  • the carrying case of the physiologic monitoring kit may further comprise a data storage unit comprising one or more storage devices, and the computation unit of the carrying case of the physiologic monitoring kit may be further configured to store at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit.
  • the storage of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit may be performed responsive to the computation unit being unable to establish, via the communications unit, a data link with the at least one external system outside the local monitoring environment.
  • step 708 output of at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of information generated therefrom on a display unit of the carrying case of the physiologic monitoring kit is controlled.
  • the at least one display of the display unit may comprise a touchscreen display, and wherein the computation unit of the carrying case of the physiologic monitoring kit may be configured to provide, via the touchscreen display, user interface features enabling dynamic selection of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom to output on the display unit.
  • the dynamic selection may be between two or more different ones of the one or more subjects, between the portion of the obtained physiologic monitoring data and the portion of the information generated therefrom, between two or more different portions of the obtained physiologic monitoring data and two or more different portions of the information generated therefrom, combinations thereof, etc.
  • the information generated from at least a portion of the obtained physiologic monitoring data may comprise one or more monitoring or treatment reports for at least one of the one or more subjects.
  • the carrying case of the physiologic monitoring kit may comprise one or more lights configured for illuminating at least a portion of at least one compartment of a housing of the carrying case in which the plurality of sensing devices and the plurality of gateway devices are stored.
  • the communications unit of the carrying case of the physiologic monitoring kit may comprise at least one microphone and at least one speaker, and the computation unit of the carrying case of the physiologic monitoring kit may be configured to establish a two-way audio communication channel utilizing the communications unit.
  • the two-way audio communication channel may be established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
  • the communications unit of the carrying case of the physiologic monitoring kit may comprise at least one camera, and the computation unit of the carrying case of the physiologic monitoring kit may be configured to establish a two-way video communication channel utilizing the communications unit and the display unit.
  • the two-way video communication channel may be established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.

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Abstract

A physiologic monitoring kit comprises a carrying case comprising a computation unit, a communications unit, a display unit, a housing, and a power supply unit configured to power the computation unit, the communications unit and the display unit. The physiologic monitoring kit also comprises a plurality of deployable devices. The computation unit is configured to manage pairing of the deployable devices with subjects. The computation unit is also configured to join, via the communications unit, a mesh network for a local monitoring environment wherein the deployable devices have been deployed. The computation unit is further configured to obtain, via the mesh network, physiologic monitoring data associated with at least one of the subjects from at least one of the deployable devices which has been deployed in the local monitoring environment. The computation unit is further configured to control output of the obtained physiologic monitoring data or information generated therefrom on the display unit.

Description

RAPID DEPLOYMENT PHYSIOLOGIC MONITORING KITS
[0001] This invention was made with government support under Medical Technology Enterprise Consortium (MTEC) Contract No.: 2019-399 awarded by the Defense Health Agency (DHA). The government has certain rights in the invention.
Technical Field
[0002] The present disclosure relates to the field of physiologic monitoring and, more particularly, to devices and systems for physiologic monitoring.
Background
[0003] Physiologic monitoring is performed for a range of purposes. Existing technologies, however, are not without shortcomings.
[0004] There is a need to measure physiologic parameters of subjects, reliably, simply, and without cables. As the proliferation of mobile and remote medicine increases, simplified and unobtrusive means for monitoring the physiologic parameters of a patient become more important.
[0005] Patient compliance is critical to the success of such systems and is often directly correlated to the ease of use and unobtrusiveness of the monitoring solution used.
[0006] Existing monitoring systems are often prone to false alarms, usage related failures, unreliable user interfaces, cumbersome interfaces, artifact or electromagnetic interference (EMI) related interference, etc. Such problems decrease productivity of using these systems, can result in lost data, and lead to dissatisfaction on the part of both the subject being monitored and the practitioners monitoring the subject. In the case of a hospital setting, the continual drone of alarms can lead to alarm fatigue and decreased productivity.
[0007] Long term compliance of subjects may suffer due to uncomfortable interfaces with monitoring devices, involved maintenance or change-over of disposables, painful or itchy reactions to materials in the devices, and the like.
[0008] More reliable, redundant, and user friendly systems are needed that can provide valuable patient data even when operating with limited supervision, expert input, or user manipulation. Summary
[0009] Illustrative embodiments provide rapid deployment physiologic monitoring kits.
[0010] In one illustrative embodiment, a physiologic monitoring kit comprises a carrying case comprising a computation unit comprising at least one processing device comprising a processor coupled to a memory, a communications unit comprising at least one network interface, a display unit comprising at least one display, a housing comprising at least one compartment, and a power supply unit comprising at least one power supply, the power supply unit being configured to power the computation unit, the communications unit and the display unit. The physiologic monitoring kit also comprises a plurality of deployable devices housed in the at least one compartment. The computation unit is configured to manage pairing of respective ones of the plurality of deployable devices with one or more subjects. The computation unit is also configured to join, via the communications unit, a mesh network for a local monitoring environment wherein at least one of the paired ones of the plurality of deployable devices has been deployed. The computation unit is further configured to obtain, via the mesh network, physiologic monitoring data associated with at least one of the one or more subjects from at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment. The computation unit is further configured to control output of at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of information generated therefrom on the display unit.
[0011] The carrying case may further comprise one or more lights, the one or more lights being configured for illuminating at least a portion of the at least one compartment.
[0012] The power supply unit may be further configured to charge at least one of the plurality of deployable devices.
[0013] The plurality of deployable devices may comprise one or more gateway devices, one or more sensing devices configured for pairing with the one or more gateway devices, and one or more smart devices. At least a given one of the one or more sensing devices may comprise a reusable component and a disposable component, the at least one compartment comprising a first compartment comprising at least one mount for attachment of the reusable component and a second compartment for storage of the disposable component.
[0014] The mesh network may be formed on one or more physical layers, each of the one or more physical layers comprising a range of frequency bands upon which data can be transferred, and the mesh network may utilize at least one mesh protocol based on at least one of a long range (LoRa) evolution schema, an ultrawideband (UWB) mesh protocol, a Bluetooth Low Energy (BLE) mesh protocol, a WiFi mesh protocol, a HaLow mesh protocol, and a private 5G mesh protocol.
[0015] The computation unit may be further configured to utilize the communications unit to establish a data link, distinct from the mesh network, with at least one external system outside the local monitoring environment. The at least one external system may comprise a remote medical facility. The data link may comprise a cellular network connection, the cellular network connection comprising at least one of a very high frequency (VHF), ultra high frequency (UHF) long-range radio connection, a tactical radio network connection, a Long- Term Evolution (LTE) cellular wide area network (WAN), and a 5G cellular WAN. The computation unit may be further configured to provide at least a portion of the obtained physiologic monitoring data or at least a portion of the information generated therefrom to the at least one external system via the data link.
[0016] The carrying case may further comprise a data storage unit comprising one or more storage devices, and the computation unit may be further configured to store at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit. The storage of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit may be performed responsive to the computation unit being unable to establish, via the communications unit, a data link with the at least one external system outside the local monitoring environment.
[0017] The at least one display of the display unit may comprise a touchscreen display, and the computation unit may be configured to provide, via the touchscreen display, user interface features enabling dynamic selection of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom to output on the display unit. The dynamic selection may be between two or more different ones of the one or more subjects, between the portion of the obtained physiologic monitoring data and the portion of the information generated therefrom, between two or more different portions of the obtained physiologic monitoring data and two or more different portions of the information generated therefrom, combinations thereof, etc.
[0018] The computation unit may be further configured to generate one or more monitoring reports for at least one of the one or more subjects based at least in part on the obtained physiologic monitoring data, and wherein said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom that is output on the display unit comprises at least one of the one or more monitoring reports.
[0019] The computation unit may be further configured to generate one or more treatment reports for at least one of the one or more subjects based at least in part on the obtained physiologic monitoring data, and wherein said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom that is output on the display unit comprises at least one of the one or more treatment reports.
[0020] The communications unit may comprise at least one microphone and at least one speaker, and the computation unit may be configured to establish a two-way audio communication channel utilizing the communications unit. The two-way audio communication channel may be established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
[0021] The communications unit may comprise at least one camera, and the computation unit may be configured to establish a two-way video communication channel utilizing the communications unit and the display unit. The two-way video communication channel may be established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
[0022] The computation unit may be further configured to monitor a device state of at least one of the plurality of deployable devices, to manage device updates for at least one of the plurality of deployable devices, combinations thereof, etc.
[0023] The physiologic monitoring kit may further comprise medical equipment utilizable for treating the one or more subjects housed in the at least one compartment. The medical equipment may comprise at least one of one or more clamps, one or more clips, one or more scissors, one or more probes, one or more forceps, one or more towel clips, and one or more suture necessities.
[0024] In another illustrative embodiment, a carrying case comprises a computation unit comprising at least one processing device comprising a processor coupled to a memory, a communications unit comprising at least one network interface, a display unit comprising at least one display, a housing comprising at least one compartment, and a power supply unit comprising at least one power supply, the power supply unit being configured to power the computation unit, the communications unit and the display unit. The computation unit is configured to manage pairing of respective ones of a plurality of deployable devices with one or more subjects. The computation unit is also configured to join, via the communications unit, a mesh network for a local monitoring environment wherein at least one of the paired ones of the plurality of deployable devices has been deployed. The computation unit is further configured to obtain, via the mesh network, physiologic monitoring data associated with at least one of the one or more subjects from at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment. The computation unit is further configured to control output of at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of information generated therefrom on the display unit.
[0025] The carrying case may further comprise one or more lights, the one or more lights being configured for illuminating at least a portion of the at least one compartment.
[0026] The power supply unit may be further configured to charge at least one of the plurality of deployable devices.
[0027] The plurality of deployable devices may comprise one or more gateway devices, one or more sensing devices configured for pairing with the one or more gateway devices, and one or more smart devices.
[0028] The computation unit may be further configured to utilize the communications unit to establish a data link, distinct from the mesh network, with at least one external system outside the local monitoring environment. The computation unit may be further configured to provide at least a portion of the obtained physiologic monitoring data or at least a portion of the information generated therefrom to the at least one external system via the data link.
[0029] The carrying case may further comprise a data storage unit comprising one or more storage devices, and the computation unit may be further configured to store at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit. The storage of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit may be performed responsive to the computation unit being unable to establish, via the communications unit, a data link with the at least one external system outside the local monitoring environment.
[0030] The at least one display of the display unit may comprise a touchscreen display, and the computation unit may be configured to provide, via the touchscreen display, user interface features enabling dynamic selection of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom to output on the display unit.
[0031] The computation unit may be further configured to generate one or more monitoring or treatment reports for at least one of the one or more subjects based at least in part on the obtained physiologic monitoring data, and wherein said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom that is output on the display unit comprises at least one of the one or more monitoring or treatment reports.
[0032] The communications unit may comprise at least one microphone and at least one speaker, and the computation unit may be configured to establish a two-way audio communication channel utilizing the communications unit. The two-way audio communication channel may be established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
[0033] The communications unit may comprise at least one camera, and the computation unit may be configured to establish a two-way video communication channel utilizing the communications unit and the display unit. The two-way video communication channel may be established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
[0034] The computation unit may be further configured to monitor a device state of at least one of the plurality of deployable devices, to manage device updates for at least one of the plurality of deployable devices, combinations thereof, etc.
[0035] In another illustrative embodiment, a method comprises managing, utilizing a computation unit of a carrying case of a physiologic monitoring kit, pairing of respective ones of a plurality of deployable devices of the physiologic monitoring kit with one or more subjects. The method also comprises joining, via a communications unit of the carrying case of the physiologic monitoring kit, a mesh network for a local monitoring environment wherein at least one of the paired ones of the plurality of deployable devices has been deployed. The method further comprises obtaining, via the mesh network, physiologic monitoring data associated with at least one of the one or more subjects from at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment. The method further comprises controlling output, on a display unit of the carrying case of the physiologic monitoring kit, of at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of information generated therefrom.
[0036] The method may further comprise establishing, via the communications unit of the carrying case of the physiologic monitoring kit, a data link distinct from the mesh network with at least one external system outside the local monitoring environment.
[0037] The method may further comprise providing, via the data link, at least a portion of the obtained physiologic monitoring data or at least a portion of the information generated therefrom to the at least one external system.
[0038] The method may further comprise storing at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in a data storage unit of the carrying case of the physiologic monitoring kit. The storage of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit may be performed responsive to the computation unit of the carrying case of the physiologic monitoring kit being unable to establish, via the communications unit of the carrying case of the physiologic monitoring kit, a data link with the at least one external system outside the local monitoring environment.
[0039] The method may further comprise establishing, utilizing the communications unit of the carrying case of the physiologic monitoring kit, a two-way audio communication channel with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
[0040] The method may further comprise establishing, utilizing the communications unit and the display unit of the carrying case of the physiologic monitoring kit, a two-way video communication channel with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
[0041] In another illustrative embodiment, a computer program product comprises a non- transitory processor-readable storage medium having stored therein executable program code which, when executed, causes a computation unit of a carrying case of a physiologic monitoring kit to manage pairing of respective ones of a plurality of deployable devices of the physiologic monitoring kit with one or more subjects. The executable program code, when executed, also causes the computation unit of the carrying case of the physiologic monitoring kit to join, via a communications unit of the carrying case of the physiologic monitoring kit, a mesh network for a local monitoring environment wherein at least one of the paired ones of the plurality of deployable devices o has been deployed. The executable program code, when executed, further causes the computation unit of the carrying case of the physiologic monitoring kit to obtain, via the mesh network, physiologic monitoring data associated with at least one of the one or more subjects from at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment. The executable program code, when executed, further causes the computation unit of the carrying case of the physiologic monitoring kit to control output, on a display unit of the carrying case of the physiologic monitoring kit, of at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of information generated therefrom.
[0042] The executable program code, when executed, may further cause the computation unit of the carrying case of the physiologic monitoring kit to establish, via the communications unit of the carrying case of the physiologic monitoring kit, a data link distinct from the mesh network with at least one external system outside the local monitoring environment. The executable program code, when executed, may further cause the computation unit of the carrying case of the physiologic monitoring kit to provide, via the data link, at least a portion of the obtained physiologic monitoring data or at least a portion of the information generated therefrom to the at least one external system.
[0043] The executable program code, when executed, may further cause the computation unit of the carrying case of the physiologic monitoring kit to store at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in a data storage unit of the carrying case of the physiologic monitoring kit. The storage of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit may be performed responsive to the computation unit of the carrying case of the physiologic monitoring kit being unable to establish, via the communications unit of the carrying case of the physiologic monitoring kit, a data link with the at least one external system outside the local monitoring environment.
[0044] The executable program code, when executed, may further cause the computation unit of the carrying case of the physiologic monitoring kit to utilize the communications unit of the carrying case of the physiologic monitoring kit to establish a two-way audio communication channel with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
[0045] The executable program code, when executed, may further cause the computation unit of the carrying case of the physiologic monitoring kit to utilize the communications unit of the carrying case of the physiologic monitoring kit to establish a two-way video communication channel with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
[0046] Advantageously, by way of example only, illustrative embodiments enable rapid deployment for physiologic monitoring of subjects in various environments, including in austere environments.
[0047] These and other features and advantages of embodiments described herein will become more apparent from the accompanying drawings and the following detailed description.
Brief Description of the Drawings
[0048] Several aspects of the disclosure can be better understood with reference to the following drawings. In the drawings, like reference numerals designate corresponding parts throughout the several views.
[0049] FIG. 1 illustrates aspects of a modular physiological monitoring system, according to an embodiment of the invention.
[0050] FIGS. 2A-2D illustrate a modular physiological monitoring system, according to an embodiment of the invention.
[0051] FIGS. 3A-3F illustrate a wearable sensor system configured for physiologic monitoring of subjects in a local monitoring environment utilizing a rapid deployment carrying case, according to an embodiment of the invention.
[0052] FIGS. 4 A and 4B illustrate a rapid care delivery deployment kit, according to an embodiment of the invention.
[0053] FIG. 5 illustrates a table of notional military roles of medical care, according to an embodiment of the invention.
[0054] FIGS. 6 A and 6B illustrate a local monitoring environment, according to an embodiment of the invention. [0055] FIG. 7 illustrates a process flow for utilizing a rapid deployment physiologic monitoring kit, according to an embodiment of the invention.
Detailed Description
[0056] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings; however, the disclosed embodiments are merely examples of the disclosure and may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure. Like reference numerals may refer to similar or identical elements throughout the description of the figures.
[0057] The accompanying drawings illustrate various embodiments of systems, methods, and embodiments of various other aspects of the disclosure. One of ordinary skill in the art will appreciate that the illustrated element boundaries (e.g., boxes, groups of boxes, or other shapes) in the figures represent one example of the boundaries. It may be that in some examples one element may be designed as multiple elements or that multiple elements may be designed as one element. In some examples, an element shown as an internal component of one element may be implemented as an external component in another, and vice versa. Furthermore, elements may not be drawn to scale. It is also noted that components and elements in the figures are not necessarily drawn to scale, emphasis instead being placed upon illustrating principles.
[0058] The words “comprising,” “having,” “containing,” and “including,” and other forms thereof, are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items, or meant to be limited to only the listed item or items.
[0059] It must also be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Although any systems and methods similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present disclosure, the preferred, systems and methods are now described. [0060] Embodiments of the present disclosure will be described more fully hereinafter with reference to the accompanying drawings in which like numerals represent like elements throughout the several figures, and in which example embodiments are shown. Embodiments of the claims may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. The examples set forth herein are non-limiting examples and are merely examples among other possible examples.
[0061] One illustrative, non-limiting objective of this disclosure is to provide systems, devices, methods, and kits for physiologic monitoring of a subject. Another illustrative, nonlimiting objective of this disclosure is to provide systems, devices, and methods for managing networks, including body area networks including different types of devices configured for physiologic monitoring of a subject, including monitoring of contextual and environmental information regarding an environment that the subject is in. Another illustrative, non-limiting objective is to provide a flexible architecture enabling sharing of contextual and environmental information about different types of devices that are part of a body area network associated with a subject. Yet another illustrative, non-limiting objective is to provide systems, devices, and methods for physiological monitoring of subjects, including physiological monitoring utilizing contextual and environmental information shared amongst different types of sensing devices that are part of a body area network associated with a subject. Yet another illustrative, non-limiting objective is to provide systems for facilitating interaction between a user and a subject with regard to physiological and/or environmental monitoring of the subject. Yet another illustrative, non-limiting objective is to provide systems, devices, methods and kits for physiologic monitoring of a subject in a remote location where power and/or local area networks are not readily available.
[0062] The above illustrative, non-limiting objectives are wholly or partially met by devices, systems, and methods according to the appended claims in accordance with the present disclosure. Features and aspects are set forth in the appended claims, in the following description, and in the annexed drawings in accordance with the present disclosure.
[0063] A modular physiological monitoring system in accordance with the present disclosure is configured to monitor one or more physiological and/or physical signals, also referred to herein as physiological parameters, of a subject (e.g., a human subject, a patient, a soldier, an athlete, a trainer, an animal such as equine, canine, porcine, bovine, etc.). The modular physiological 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.). In aspects, the physiological monitoring system may also include one or more modules (also referred to as hubs in some illustrative embodiments), 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 physiological and/or physical signals, signals derived therefrom, and/or metrics derived therefrom obtained via the interface with the subject.
[0064] Each module may include a power source (e.g., a battery, a rechargeable battery, an energy harvesting transducer, 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, etc.), signal conditioning circuitry, communication circuitry, one or more sensors, or the like, configured to generate one or more signals (e.g., physiological and/or physical signals), stimulus, etc.
[0065] 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.
[0066] In aspects, the patch may be configured so as to be single use (e.g., disposable). The patch may include a thin, breathable, stretchable laminate. In aspects, 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 a corresponding module.
[0067] In aspects, to retain a high degree of comfort and long term wearability of the patch on a subject, to limit interference with normal body function, to limit interference with joint movement, or the like, the patch may be sufficiently thin and frail, such that it may not substantially retain a predetermined shape while free standing. Such a definition is described in further detail below. 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. Upon removal of the patch from the subject, 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). In aspects, 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 from the skin of the subject may result in a permanent loss in shape of the patch without tearing of the patch. In aspects, the interconnect may be sufficiently frail such that removal of the patch from the skin of the subject may result in a permanent loss of shape of the interconnect.
[0068] In aspects, 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. In aspects, 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), is greater than 8: 1, greater than 4: 1, greater than 2: 1, or the like. Such a configuration may be advantageous so as to ensure the patch may be easily and reliably removed from the subject after use without tearing.
[0069] In aspects, 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. Such 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.
[0070] In aspects, 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. Such 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. In aspects, a patch 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.
[0071] In aspects, 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.
[0072] In aspects, 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 absorption 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. In aspects, 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/m2/24hrs) and 20,000g/m2/24hrs, between 500g/m2/24hrs and 12,000g/m2/24hrs, between 2,000g/m2/24hrs and 8,000g/m2/24hrs, or the like.
[0073] Such a configuration may be advantageous for providing a comfortable wearable physiological 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.
[0074] In aspects, one or more patches and/or modules may be configured for electrically conducting interconnection, inductively coupled interconnection, capacitively coupled interconnection, with each other. In the case of an electrically conducting interconnect, each patch and module interconnect may include complementary electrically conducting connectors, configured and dimensioned so as to mate together upon attachment. In the case of an inductively or capacitively coupled interconnect, the patch and module may include complementary coils or electrodes configured and dimensioned so as to mate together upon attachment.
[0075] Each patch or patch-module set may be configured as a sensing device to monitor one or more local physiological 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. Each patch and/or patch-module set 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 and/or other source, the signaling being based on analysis of the physiological and/or physical parameters of the subject measured by the sensing device(s).
[0076] The patch or patch-module sets are examples of what are more generally referred to herein as “primary” sensing devices, which are advantageously designed as on-body sensing devices with a small form factor as part of the modular monitoring system. While such primary sensing devices may be used to obtain some desired information (e.g., local physiological and/or physical parameters of the attached subject, local environment, combinations thereof, etc.), in some cases it is beneficial to obtain contextual information from other types of sensors which are difficult to integrate into such primary sensing devices designed as on-body sensing devices with small form factors. Such other types of sensors may be integrated into “secondary” or accessory sensing devices that do not have the limitations of the “primary” sensing devices. For example, while the primary sensing devices may be designed as on-body sensing devices with a small form factor for comfortable long-term wear by the subject, the secondary or accessory sensing devices may have larger form factors to accommodate different types of sensors than the primary sensing devices. It should be noted that the secondary or accessory sensing devices may be incorporated into equipment or gear that is carried by a subject, into one or more wearable computing devices, a carrying case of a rapid care delivery deployment kit, etc. In some cases, an accessory sensing device is directly attached to the body of the subject. Also, in some embodiments, primary sensing devices can be attached or otherwise incorporated in equipment or gear carried by the subject, including but not limited to rapid care delivery deployment kits.
[0077] The on-body physiological monitoring or other primary sensing devices can benefit from additional contextual and environmental information about the conditions surrounding a subject under study, where the additional contextual and environmental information may be obtained from one or more accessory sensing devices. For example, the primary sensing devices may be used to acquire one or more physiological metrics of the subject such as heart rate, core temperature, respiratory cycle status, etc. Such physiological metric data may be augmented by contextual or environmental data obtained using primary sensing devices and/or additional external sensing capabilities of accessory sensing devices, where the devices may target exposure of the subject to infectious agents, insolation, etc. This contextualization capability may, under some circumstances, need to be flexible, requiring different sensing modalities at different times with different subjects under study. In addition, some sensors may not be easily integrated into a single primary (e.g., on-body) sensing device with a small form factor, and thus may need to be externalized into one or more accessory sensing devices that may be placed at different locations relative to the primary sensing devices on the same individual. These various primary and accessory sensing devices may require a dedicated body area network to manage their functions, to enable efficient data sharing among them, and to facilitate contextual analysis of the different data obtained therefrom.
[0078] In aspects, the host device (also referred to as a gateway in some illustrative embodiments) may be configured to coordinate information exchange to/from each module and/or patch or other on-body primary sensing device as well as accessory sensing devices that are part of a body area network associated with a subject, and to generate one or more physiological 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 electronic health record or EHR, a social network, an field operational network, etc.), a processor, combinations thereof, or the like. In aspects, the host device may include features for recharging and/or performing diagnostic tests on one or more of the modules. In aspects, a host device in accordance with the present disclosure may be integrated into a subject’s equipment or gear, 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. The host device may also be part of a carrying case in a rapid care delivery deployment kit.
[0079] In aspects, 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, 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 an interconnect suitable for attachment to an associated module. Upon attachment of a module to a corresponding patch, the module may validate the type and operation of the patch to which it has been mated. In aspects, the module may then initiate monitoring operations on the subject via the attached patch, communicate with one or more other patches and/or modules on the subject, a wireless gateway or other host device, 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 sets on the subject, between subjects, etc. Thus, if a module is to be replaced, a hot swappable replacement (e.g., replacement during a monitoring procedure) can be carried out easily by the subject, a caregiver, practitioner, etc., during the monitoring process. 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.
[0080] 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. In aspects, the time synchronization may be performed every second, every ten seconds, every thirty seconds, every minute, or the like. In aspects, 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. In some embodiments, a carrying case of a rapid care delivery deployment kit may provide the time synchronization service for sensing devices and wireless gateways in a local monitoring environment.
[0081] In a time aligned configuration, 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. As such, 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.
[0082] In aspects, 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. In aspects, an event may be one or more temporally-triggered events, one or more spatially-triggered events, one or more occurrence-triggered events, a combination thereof, or the like.
[0083] In aspects, 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. In aspects, 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.
[0084] In addition to physiological 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.
[0085] According to aspects, there is provided use of a modular physiological monitoring system in accordance with the present disclosure to monitor a subject, to monitor an electrocardiogram (EKG) of a subject, to perform one or more tasks in accordance with the present disclosure, etc.
[0086] According to aspects, there is provided an interface (e.g., a patch in accordance with the present disclosure) for monitoring a physiological, physical, and/or electrophysiological signal from a subject. 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%.
[0087] According to aspects, there is provided 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. In aspects, the conducting adhesive may include an anisotropically conducting adhesive, with the direction of conduction oriented substantially normal to the surfaces of the substrate.
[0088] In aspects, 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. [0089] In aspects, 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. In aspects, 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. In aspects, a gel adhesive in accordance with the present disclosure located adjacent to the electrode features (e.g., between the features and the skin) 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.
[0090] In aspects, 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.
[0091] In aspects, the 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.
[0092] According to aspects, there is provided a device (e.g., a module in accordance with the present disclosure) for monitoring a physiological, physical, and/or electrophysiological signals 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 PCB 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. In aspects, 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. In aspects, the housing may be shaped like a dome and the antenna may be patterned into a spiraling helix centered within the dome. [0093] In aspects, 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. The module may include a sensor and/or microelectronics configured to interface with a sensor included on a corresponding patch. In aspects, one or more of the sensors may include an electrophysiological 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.
[0094] In aspects, the module may be hermetically sealed. The module and/or patch 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.
[0095] In aspects, the module interconnect may include an electrically conducting magnetic element, and the patch 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 when the magnetic elements are aligned with the ferromagnetic regions. In aspects, the ferromagnetic regions may be formed from stretchable pseudo elastic material and/or may be printed onto the substrate. In aspects, the module and/or the patch may include one or more fiducial markings to visually assist with the alignment of the module to the patch during coupling thereof.
[0096] According to aspects, there is provided a kit for monitoring one or more physiological, physical, and/or electrophysiological signals 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. One or more other ones of the accessories may include an accessory sensing device configured to complement (e.g., provide contextual or environmental information that augments) physiological data obtained from patches and/or patch-module sets providing primary sensing devices. [0097] In some embodiments, the kit comprises a rapid care delivery deployment kit including a carrying case configured to hold and store a number of sensing devices (e.g., patchmodule sets) as well as wireless gateways. Each wireless gateway may be associated with the carrying case and one user in a group of users that is in a local monitoring environment (e.g., a remote or austere environment with limited connectivity). The sensing devices may be paired with the wireless gateways, and then used for physiologic monitoring of the different users in the group of users. Each of the wireless gateways may manage the sensing devices in a BAN associated with one of the users in the group of users, while the carrying case may manage the group of wireless gateways. This may include coordinating physiologic monitoring among the group of users, storing and/or communicating the physiologic monitoring data associated with different ones of the users in the group of users to an external network, etc.
[0098] According to aspects there is provided a service system (e.g., via one or more wireless gateways, a carrying case of a rapid care delivery deployment kit) for managing the collection of physiological and/or other data from one or more subjects in a group of subjects, including a subject data management service, configured to generate and/or store subject profiles referencing customer preferences, data sets, and/or monitoring sessions, an automated product delivery service configured to provide the subjects 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 subjects during one or more monitoring sessions.
[0099] In aspects, 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 subjects or a responsible entity based upon the number or patches consumed, the data stored, and/or the reports generated throughout the course of one or more monitoring sessions.
[00100] According to aspects, there is provided a method for monitoring one or more physiological 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 physiological and/or electrophysiological signals from each of the devices, obtaining contextual or environmental information from secondary or accessory sensing devices, and analyzing the signals obtained from the primary and secondary sensing devices to generate a metric, diagnostic, report, and/or additional signals therefrom.
[00101] In aspects, 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. In aspects, 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.).
[00102] In aspects, 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.
[00103] In aspects, one or more steps of a method in accordance with the present disclosure may be performed at least in part by one or more devices, patches, modules, and/or systems each in accordance with the present disclosure.
[00104] According to aspects, there is provided 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 or more temporal metrics from the signals in combination with one or more calibration parameters, to determine the blood pressure of the subject.
[00105] In aspects, 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. [00106] In aspects, 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. Some non-limiting examples of orientation sensors include one or more of an altimeter, a barometer, a tilt sensor, a gyroscope, combinations thereof, or the like. [00107] A system for measuring the effect of an impact on a physiological state of a subject including 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 effect of the impact on the subject.
[00108] In aspects, 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. In aspects, 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.
[00109] In aspects, 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.
[00110] In aspects, the system for measuring the effect of an impact on a physiological 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. In aspects, the processor may be configured to extract a heart rate variability (HRV) signal from the EKG signal, to compare a pre impact and post impact portion of the HRV signal to determine at least a portion of the effect of the impact, etc.
[00111] According to aspects, there is provided 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.
[00112] In aspects, 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.
[00113] In aspects, 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. [00114] In aspects, 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, to identify snoring, to identify a sleep apnea event, to identify a bruxism event, to identify a rapid eye movement (REM) sleep state, to identify a sleep walking state, a sleep talking state, a nightmare, or to identify a waking event. In aspects, 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.
[00115] A modular physiological monitoring system, in some embodiments, 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 physiological 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 physiological monitoring system may include 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. 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.
[00116] The sensing devices of a modular physiological monitoring system, such as patchmodule sets described below with respect to FIG. 1, may be used to monitor one or more physiological functions or parameters of a subject, as will be described in further detail below. The sensing devices of the modular physiological 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 physiological 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.
[00117] Exemplary sensing devices, monitoring systems, body area networks, and the like will be described in conjunction with the figures. Note that patch-module sets or pairs are examples of such sensing devices.
[00118] Referring initially to FIG. 1, aspects are disclosed of a modular physiological monitoring system in accordance with the present disclosure. In FIG. 1, a subject 1 is shown with a number of patches and/or patch-module sets 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. In some embodiments, the feedback devices 135, 140 may also or alternatively function as stimulating devices. The host device 145, the feedback/user device 147, the patches and/or patch-module sets, and/or the feedback devices 135, 140 may be configured for wireless communication 146, 149 during a monitoring session.
[00119] In aspects, a patch-module set may be adapted for placement almost anywhere on the body of a subject 1. As shown in FIG. 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.), 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 calf muscle 70, on a knee 35 particularly for proprioception based studies and impact studies, on a shin 30 primarily for impact studies, on an ankle 65, over an Achilles tendon 20, on the front or top of the foot 15, on a heel 5, or around the bottom of a foot or toes 10. Other sites for placement of such devices are envisioned. Selection of the monitoring and/or stimulating sites is generally determined based upon the intended application of the patch-module sets described herein. [00120] 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.
[00121] Placement sites on the wrist 144a, hand 144b or the like may advantageous for interacting with a subject, such as via performing a stress test, performing a thermal stress test, performing a tactile stress test, monitoring outflow, afferent traffic, efferent traffic, etc.
[00122] 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.
[00123] Placement sites on the face 141, over ocular muscles, near the eye, over a facial muscle (e.g., a nasalis, temporalis, zygomaticus minor/major, orbicularis oculi, occipitofrontalis), near a nasal canal, over a facial bone (e.g., frontal process, zygomatic bone/surface, zygomaticofacial foreman, malar bone, nasal bone, frontal bone, maxilla, temporal bone, occipital bone, etc.), may be advantageous to assess ocular function, salivary function, sinus function, interaction with the lips, interaction with one or more nerves of the PNS (e.g., interacting with the vagus nerve within, on, and/or near the ear of the subject), etc.
[00124] In aspects, a system in accordance with the present disclosure may be configured to monitor one or more physiological parameters of the subject 1 before, during, and/or after one or more of, a stress test, consumption of a medication, exercise, a drill, a mission, 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. [00125] Additional details regarding modular physiological monitoring systems, kits and methods are further described in PCT application serial no. PCT/US2014/041339, published as WO 2014/197822 and titled “Modular Physiological Monitoring Systems, Kits, and Methods,” PCT application serial no. PCT/US2015/043123, published as WO 2016/019250 and titled “Modular Physiological Monitoring Systems, Kits, and Methods,” PCT application serial no. PCT/US2017/030186, published as WO 2017/190049 and titled “Monitoring and Management of Physiological Parameters of a Subject,” PCT application serial no. PCT/US2018/062539, published as WO 2018/098073 and titled “Continuous Long-Term Monitoring of a Subject,” PCT application serial no. PCT/US2018/043068, published as WO 2019/023055 and titled “Physiological Monitoring Kits,” PCT application serial no. PCT/2019/033036, published as WO 2019/226506 and titled “Monitoring Physiological Parameters for Timing Feedback to Enhance Performance of a Subject During an Activity,” PCT application serial no. PCT/US2020/031851, published as WO 2020/227514 and titled “Monitoring and Processing Physiological Signals to Detect and Predict Dysfunction of an Anatomical Feature of an Individual,” PCT application serial no. PCT/US2021/033441, published as WO 2021/236948 and titled “Gateway Device Facilitating Collection and Management of Data from a Body Area Network to Study Coordinating System,” PCT application serial no. PCT/US2021/028611, published as WO 2021/216847 and titled “Visualizing Physiological Data Obtained from Subjects,” PCT application serial no. PCT/US2021/033442, published as WO 2021/236949 and titled “Non-Invasive Detection of Anomalous Physiological Events Indicative of Hypovolemic Shock of a Subject,” PCT application serial no. 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,” and 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.
[00126] In some embodiments, modular 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. For example, the sensing and stimulating devices may include different ones of the patch-module sets described above with respect to FIG. 1. In other embodiments, one or more devices may provide both monitoring and stimulating functionality. For example, one or more of the patch-module sets 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 sets 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.
[00127] The sensing and/or stimulating devices of a modular physiological monitoring system may be configured for radio frequency (RF) or other wireless and/or wired connection with one another and/or a host device (e.g., a wireless gateway, a carrying case of a rapid care delivery deployment kit, combinations thereof, etc.). 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, for example, may be provided based on measurements of physiological parameters that are obtained using the sensing devices to determine when events related to cardiac and/or other physiological 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.
[00128] During and/or after stimulus is applied with the stimulating devices, the sensing devices may monitor the physiological 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.
[00129] In some embodiments, a user of the modular physiological 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 physiological monitoring system. The user of the modular physiological 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, a supervisor, a group leader, a medic, etc., of the subject being monitored and stimulated. The user may also have the option to disconnect or shut down the modular physiological monitoring system at any time, such as via operation of a switch, pressure sensation, voice operated instruction, etc. [00130] Stimulus or feedback which may be provided via one or more stimulating devices in a modular physiological 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.
[00131] 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.
[00132] 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.
[00133] 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.). [00134] As described above, the modular physiological 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 physiological monitoring system, however, may also operate as or provide a type of cardiac “pacemaker” in other embodiments. In such embodiments, the modular physiological monitoring system has the potential to reduce the frequency of cardiac events, or to possibly avoid certain cardiac events altogether. A modular physiological 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.
[00135] In some embodiments, a modular physiological 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. In addition, in some embodiments 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.
[00136] Modular physiological 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 effect), light color or brightness, etc.
[00137] Stimulus amplification may also be provided by one or more modular physiological 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. As an example, 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.
[00138] Another example of 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.
[00139] In some embodiments, the stimulating devices in a modular physiological 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, in some embodiments, may be distinct from the sensing devices in the modular physiological monitoring system in that the sensing devices in the modular physiological monitoring system may be used to measure physiological parameters of the subject while the sensing electrodes on the stimulation devices in the modular physiological monitoring system may be utilized to monitor the application of a stimulus to the subject.
[00140] 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., physiological parameters related to cardiac output). As such, 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. By monitoring the neural response to the stimulus, 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. [00141] 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 physiological monitoring system and/or one or more of the sensing electrodes of the stimulating devices in the modular physiological 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. Thus, 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.
[00142] A stimulating device applied to the subject via an adhesive (e.g., an adhesively applied stimulating device), 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.
[00143] 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.
[00144] 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.
[00145] 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.
[00146] 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.
[00147] One or more stimulating devices may also be incorporated in other systems, such as stimulating devices integrated into a bed, chair, operating table, 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 physiological parameters of the subject utilizing one or more sensing devices. Similarly, equipment that the subject is wearing or carrying can have one or more stimulating devices incorporated therein and/or thereon.
[00148] Although the disclosure has discussed devices attached to the body for monitoring aspects of the subject’s disorder and/or physiological information, as well as providing a stimulus, therapeutic stimulus, etc., alternative devices may be considered. 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.
[00149] In some embodiments, aspects of monitoring the subject utilizing sensing devices in the modular physiological 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. To achieve reliable recordings, it is advantageous to have such surfaces be well positioned against the subject. It is also advantageous to build such surfaces to take into account comfort level of the subject to keep the subject from feeling the sensing surfaces and to maintain use of the sensing surface over time.
[00150] Stimulating devices, as discussed above, may take the form of audio, visual or audiovisual systems or devices in the sleep space of the subject. Examples of such stimulating devices include smart speakers. Such stimulating devices provide a means for instructing 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. Examples of such non-contacting stimulating devices include systems such as Amazon Echo®, Google Home®, Apple Home Pod®, and the like.
[00151] FIGS. 2A-2D show a modular physiological monitoring system 200. The modular physiological monitoring system 200 includes a sensing device 210, an accessory device 215 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. In some embodiments, the accessory sensing device 215 is mounted on equipment carried by the subject 201, such as a firearm, firearm holster, etc. As will be described in further detail elsewhere herein, the hots device 230 may be embodied as a wireless gateway and/or a carrying case of a rapid care delivery deployment kit.
[00152] 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.
[00153] The memory may comprise random access memory (RAM), read-only memory (ROM) or other types of memory, in any combination. 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.
[00154] The network interface provides circuitry enabling wireless communication between the host device 230, the sensing device 210, the accessory device 215 and the stimulating device 220.
[00155] FIG. 2A illustrates a modular physiological monitoring system 200 that includes only a single instance of the sensing device 210, the accessory device 215 and the stimulating device 220 for clarity. It is to be appreciated, however, that modular physiological monitoring system 200 may include multiple sensing devices, accessory devices, and/or stimulating devices. In addition, although FIG. 2A illustrates a modular physiological monitoring system 200 in which the sensing device 210 and the stimulating device 220 are attached to the subject 201 while the accessory device 215 is not attached to the subject 201, embodiments are not limited to such arrangements. As described above, one or more sensing and/or stimulating devices may be part of contacting surfaces or non-contacting devices. Further, accessory devices may alternatively be “on-body” or attached to the subject 201 as described elsewhere herein. In addition, the placement of sensing device 210 and stimulating device 220 on the subject 201 may vary as described above. Also, the host device 230 (and possibly the accessory device 215) 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, the accessory device 215 and the stimulating device 220. In some embodiments, as will be described in further detail below, the functionality of the host device 230 may be provided at least in part using cloud computing resources.
[00156] FIG. 2B shows a schematic diagram of aspects of the sensing device 210 in modular physiological 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 accessory device 215, the stimulating device 220 and the host device 230. [00157] FIG. 2C shows a schematic diagram of aspects of the stimulating device 220 in modular physiological 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, the accessory device 215, and the host device 230.
[00158] FIG. 2D shows a schematic diagram of aspects of the accessory device 215 in modular physiological monitoring system 200. The accessory device 215 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 accessory device 215 is configured for wireless communication 225 with the sensing device 210, the stimulating device 220, and the host device 230.
[00159] Communication of data from the sensing devices and/or stimulating devices (e.g., patches and/or patch-module sets), as well as accessory devices, may be performed via a local personal communication device (PCD). Such communication in some embodiments takes place in two parts: (1) local communication between a patch and/or patch-module set (e.g., via a hub or module of a patch-module set) 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. The PCD may also be part of or provide functionality of an accessory device. In some embodiments, the host device 230 provides the PCD. As noted above, the host device 230 may be embodied as a wireless gateway and/or a carrying case of a rapid care delivery deployment kit.
[00160] FIGS. 3A-3F show a wearable sensor system 300 configured for monitoring physiologic, location, and contextual and/or environmental data for a plurality of users, and for analyzing such data for use in health monitoring, event detection, etc. The wearable sensor system 300 provides the capability for assessing the condition of the human body of a plurality of users (e.g., including user 336 and a crowd of users 338). As shown in FIG. 3 A, the wearable sensor system 300 includes a wearable device 302 that is affixed to user 336, as well as one or more accessory devices 315 having sensors configured for capturing contextual and/or environmental information for the user 336 and/or the crowd of users 338. While the wearable device 302 is shown as being “on-body” relative to the user 336, the accessory devices 315 may, but are not required to be, “off-body” devices relative to the user 336 and/or the crowd of users 338. The accessory devices 315, for example, may comprise, be attached to, or otherwise incorporate within a firearm or other equipment that is carried on or worn by the user 336.
[00161] The user 336 and the crowd of users 338 are part of a local monitoring environment 301, which may be a remote or austere environment. The local monitoring environment 301 may be configured with rapidly deployable physiologic monitoring capability via a rapid care delivery deployment kit. The rapid care delivery deployment kit provides rapidly deployable physiologic monitoring capability “in a box” via rapid deployment carrying case 390, which is a mobile case that may be brought to the local monitoring environment 301. The rapid deployment carrying case 390 includes a housing storing, among other things, various sensing devices (e.g., wearable device 302 and accessory devices 315) and wireless gateways (e.g., wireless gateway 340). Each of the wireless gateways stored in the rapid deployment carrying case 390 is assumed to be paired with a communications unit of the rapid deployment carrying case 390, and may be dynamically paired or otherwise associated with one of the user 336 or a user in the crowd of users 338. Different ones of the sensing devices stored in the rapid deployment carrying case 390 may be dynamically paired or associated with different ones of the wireless gateways. Once a given sensing device is paired or associated with a given wireless gateway associated with a given one of the user 336 or a user in the crowd of users 338, the given sensing device may be attached to or otherwise placed in or near the given user to perform physiologic, contextual and/or environmental monitoring of the given user. The wireless gateways, which are associated with different ones of the user 336 and users in the crowd of users 338, relay physiologic, contextual and/or environmental monitoring data from its associated sensing devices to the rapid deployment carrying case 390 in the local monitoring environment 301. The rapid deployment carrying case 390 may store such data, perform analysis thereof, and relay the data via network 384 to the artificial intelligence (Al) wearable device network 348 and/or one or more third-party networks 368. The rapid deployment carrying case 390 may do so when its communications unit is able to establish connectivity to the network 384 outside the local monitoring environment 301. [00162] The local monitoring environment 301 may include, for example, training and operational safety scenarios, natural disasters (e.g., flooding, fires, violent storms, etc.), accident sites (e.g., train accidents, building collapses, boat crashes, etc.), terrorist attacks, etc. which involve the user 336 and the crowd of users 338. In some cases, one or more of the user 336 and users in the crowd of users 338 are part of first responder teams, search and rescue teams, etc., which are deployed to the local monitoring environment 301 to respond to these and other scenarios. Often in such scenarios, commercial communication networks may be damaged and/or have limited availability in the local monitoring environment 301. Consider, as an example, a natural disaster such as a tornado where many people are injured. First responders may enter the affected area (e.g., the local monitoring environment 301) with a rapid care delivery deployment kit including the rapid deployment carrying case 390, and may distribute wireless gateways and sensing devices to the injured persons in the local monitoring environment 301 to monitor the aftermath of the tornado, and locate, stabilize and evacuate survivors. Such actions may be coordinated through physiologic, contextual and/or environmental monitoring data that is collected from the sensing devices and communicated, via the wireless gateways, to the rapid deployment carrying case 390.
[00163] The rapid care delivery deployment kit may include everything needed to quickly deploy real-time monitoring capabilities to the user 336 and the crowd of users 338 in the local monitoring environment 301 (e.g., an austere environment). The rapid deployment carrying case 390 of the kit is configured to join a mesh network for transferring data from the user 336 and the crowd of users 338 to one or more authorized entities (e.g., leadership, cadre, caregivers, nurses, first responders, etc.). The wireless gateway 340 associated with user 336 and other wireless gateways associated with the crowd of users are configured, in some embodiments, to automatically establish the mesh network. The wireless gateway 340, for example, has an internal processor and works together with other wireless gateways to get data to end users (e.g., smartphones of the end users), and back to network exit points (e.g., smartphones, a computation unit of the rapid deployment carrying case 390, etc.).
[00164] The mesh network may be formed on one or more physical layers, each physical layer comprising a range of frequency bands, upon which data can be transferred. The mesh network may comprise at least one mesh protocol based on a long range evolution schema, an ultrawideband (UWB) mesh protocol, a Bluetooth Low Energy (BLE) mesh protocol, a WiFi mesh protocol, a HaLow mesh protocol, a private 5G mesh protocol, or the like. [00165] The mesh network of devices may be configured to use time of flight (TOF), time difference of arrival (TDoA), and phase difference of arrival (PDoA) technologies, or the like to enable extremely accurate (e.g., within a centimeter) distance and location tracking and two- way ranging capabilities between subjects in the network. The smart devices may be equipped with applications (e.g., the Android Tactical Awareness Kit (ATAK), iTAK, Kill Switch, winTAK, or the like) in order to visualize such location-based relationships between the devices.
[00166] The rapid care delivery deployment kit may include sensing devices (e.g., wearable physiologic sensors such as wearable device 302 and/or accessory devices such as accessory devices 315) for each of the users to be monitored (e.g., the user 336 and the crowd of users 338). The rapid care delivery deployment kit may further include accompanying or integrated communication devices (e.g., PCDs, such as wireless gateway 340) for use in establishing a local network among the user 336, the crowd of users 338 and the rapid deployment carrying case 390. Each of the PCDs or wireless gateways may manage the BAN associated with a single one of the user 336 or a user in the crowd of users 338, with a local or mesh network being established between the rapid deployment carrying case 390 and the different PCDs or wireless gateways.
[00167] The rapid deployment carrying case 390, as will be discussed in further detail below with respect to FIG. 3F, may also include: one or more processing devices or other compute hardware for generating or deriving reports or metrics from the physiologic, contextual and/or environmental data associated with the user 336 and the crowd of users 338; one or more visualization devices (e.g., a touchscreen display or other type of display unit) for supervisors and/or caregivers to view the physiologic, contextual and/or environmental data associated with the user 336 and the crowd of users 338 (or reports or metrics which are derived or generated therefrom), to manage or organize the sensing devices and/or wireless gateways, to provide video conferencing capability, etc.; one or more data storage devices for storing the physiologic, contextual and/or environmental data associated with the user 336 and the crowd of users 338 (or reports or metrics which are derived or generated therefrom); communication hardware for offloading the physiologic, contextual and/or environmental data (or metrics or reports which are generated or derived therefrom) to the Al wearable device network 348 and/or the third-party networks 368; and a power supply for charging the sensing devices and/or wireless gateways, for powering the compute hardware, the visualization devices, the communication hardware, etc. In some embodiments, the communication hardware provides a long-range communication system to provide a data link between the local monitoring environment 301 and a remote site (e.g., the Al wearable device network 348, the third-party networks 368, etc.). The remote site may include a hospital, a role 2 facility, a role 1 facility, a fire station, a command center, etc. The rapid deployment carrying case 390 may, in some cases, include sensing devices embodied as patch-module sets, wireless gateways, smart devices (e.g., smartphones, tablets, etc.), one or more displays, compute hardware, a radio system or other communication hardware, a mass storage drive or other data storage devices, etc.
[00168] The network 384 may comprise a physical connection (wired or wireless), the Internet, a cloud communication network, etc. Examples of 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. In the system 300, the local monitoring environment 301 is connected to the network 384 via the rapid deployment carrying case 390. Also coupled to the network 384 is the Al wearable device network 348 and a verification entity 386 coupled to the third-party networks 368. Detailed views of the wearable device 302, wireless gateway 340, Al wearable device network 348, the third-party networks 368, and the rapid deployment carrying case 390 are shown in FIGS. 3B-3F, respectively.
[00169] In some embodiments, the wearable device 302 is implemented using one or more patch-module sets as described above with respect to FIGS. 1 and 2A-2C. The patch-module sets described above with respect to FIGS. 1 and 2A-2C, however, are just one example of wearable technology that may be used to provide the wearable device 302. Various other types of wearable technology may be used to provide the wearable device 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 microcontrollers) 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. [00170] In some embodiments, 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, via the wireless gateway 340 and the rapid deployment carrying case 390. 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 or in other remote environments (e.g., the local monitoring environment 301) outside health care facilities. The wearable device 302 is designed to monitor the cardiopulmonary state of a subject (e.g., 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.
[00171] In some embodiments, the wearable device 302 collects physiologic monitoring data from the subject user 336 utilizing a combination of a disposable sampling unit 312 and a reusable sensing unit 314 shown in FIG. 3B. The patch-module sets 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. For example, 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.
[00172] In addition to the disposable sampling unit 312 and reusable sensing unit 314, 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 UWB communication unit 332, contextual analysis module 334 and sensor data reconstruction module 339.
[00173] The power source or component 304 of the wearable device 302, in some embodiments, 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.).
[00174] 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. In some embodiments, 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.
[00175] 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.), cloudbased processing units (e.g., Amazon Web Services (AWS) processing units), edge computing systems, embedded systems (e.g., Nvidia® Jetson™), 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 contextual analysis module 334 and the sensor data reconstruction module 339 described below. The processor 308 is illustratively coupled to the memory 310, with the memory 310 storing such computer-readable program instructions.
[00176] 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. In some embodiments, 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.
[00177] 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 contextual analysis module 334 and/or the sensor data reconstruction module 339 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. Although not explicitly shown, other components of the wearable sensor system 300 (e.g., the accessory devices 315, the wireless gateway 340 shown in FIG. 3C, the Al wearable device network 348 shown in FIG. 3D, one or more of the third-party networks 368 shown in FIG. 3E, the verification entity 386, the rapid deployment carrying case 390 shown in FIG. 3F, etc.) may also include one or more processors coupled to one or more memories providing processing devices implementing the functionality of such components.
[00178] As noted above, 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 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.). In some embodiments, 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. In some embodiments, 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. In such embodiments, 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) may be returned, sterilized and reused (e.g., by the same user 336 or another user) while the patch or disposable sampling unit 312 is disposed of. In some embodiments, 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. In such embodiments, the patch or disposable sampling unit 312 may be disposed of after the monitoring duration has ended.
[00179] 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 gyroscope sensors 326, one or more audio sensors 328, and one or more other sensors 329. One or more of the sensors 316-329 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, transceivers, sacrificial structures, water soluble structures, temperature sensitive structures, light sensitive structures, light degrading structures, flexible light emitting elements, piezoresistive elements, moisture sensitive elements, mass transfer altering elements, etc.
[00180] In some embodiments, one or more of the sensors 316-329 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 316-329 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 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.
[00181] Changes in core temperature readings from multiple sensor readings over some designated period of time (e.g., a transit! onary period where two wearable devices are attached to the user 336 and obtain core temperature readings) are analyzed to generate correlation parameters that relate changes in core temperature readings from the multiple sensors. In some embodiments, 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. Consider an example where a first set of one or more sensors is at a first site on the user 336 and a second set of one or more sensors is at a second site on the user 336, with the first site being associated with a lower thermal gradient than the second site but with the second site being more conducive to long-term wear relative to the first site. In such cases, it may be desired to obtain core temperature readings from the first and second sets of sensors, establish the correlation parameter, and then subsequently use only the second set of sensors at the second site more conducive to long-term wear by the user 336. In some embodiments, the temperature sensors 316 comprise one or more digital infrared temperature sensors (e.g., Texas Instruments TMP006 sensors). [00182] The heart rate sensors 318 in some embodiments 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.). In some embodiments, the physiological parameters comprise one or more bioimpedance measurements, and 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.
[00183] 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.
[00184] 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.
[00185] 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. The accelerometer sensors 324 may also be used for sensing muscle contraction for various activities, such as running and other erect sports. In the case of running and other erect sports, resistance rises as either (or both) of the right and left extremities (e.g., feet, shins, knees, etc.) strike the ground. This rise or peak may be synchronized to bolus ejection as detailed herein. 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.
[00186] The gyroscope sensors 326 are configured to measure orientation and angular velocity, and may be used to detect deviation of an object (e.g., the sensing unit 314, the wearable device 302) from a desired orientation.
[00187] The audio sensors 328 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. In some embodiments, the audio sensors 328 may include ultrasonic transducer receivers capable of converting ultrasound into electrical signals. [00188] It should be noted that the sensors 316-328 described above are presented by way of example only, and that the sensing unit 314 may utilize various other types of sensors 329 as described elsewhere herein. For example, in some embodiments the other sensors 329 include one or more of motion sensors, humidity sensors, cameras, radiofrequency receivers, thermal imagers, radar devices, lidar devices, ultrasound devices, speakers, etc.
[00189] 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.
[00190] 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. Notably, UWB also uses a wide spectrum of several gigahertz (GHz). The functioning of a UWB sensor is to provide the ability to continuously scan an entire room and provide spatial awareness data to the wearable device 302, improving the localization of the wearable device 302 particularly in conjunction with use of the GPS unit 330.
[00191] The contextual analysis module 334 is configured to execute various functionality for combining sensor data from the sensing unit 314 (e.g., physiologic monitoring data for the user 336) along with sensor data from the accessory devices 315 (e.g., contextual and/or environmental information associated with the user 336 and/or the crowd of users 338) for higher-level analysis.
[00192] The sensor data reconstruction module 339 is configured to execute various functionality for reconstructing sensor data from the sensing unit 314 and/or the accessory devices 315 (e.g., to correct for missing, erroneous, corrupt or contaminated data, to account for sensors of the sensing unit 314 and/or the accessory devices 315 which have been destroyed, disabled or are otherwise unable to produce sensor data, to account for sensors of the sensing unit 314 and/or the accessory devices 315 which are inherently limited in what data the can produce and convey, etc.).
[00193] The user 336 may be a human or animal to which the wearable device 302 is attached. Sensor data and localization data collected by the wearable device 302, along with contextual and/or environmental data collected from the accessory devices 315, may be provided to Al wearable device network 348 for analysis, with portions or such analysis being provided to one or more of the third-party networks 368 for various purposes. Communication of the sensor and localization data from the wearable device 302, as well as communication of the contextual and/or environmental data from the accessory devices 315, to the Al wearable device network 348 may take place via the 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 using the rapid deployment carrying case 390.
[00194] As shown in FIG. 3C, 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 316-329 of the wearable device 302. The user profile 344, for example, may include information such as a name (e.g., first, last and middle name), biological sex, 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 344 may also include known diseases and disorders (e.g., asthma, allergies, current medications, family medical history, other medical data, etc.), where such information may include Protected Health Information (PHI) regulated by American Health Insurance Portability and Accountability Act (HIPAA) or other applicable rules and regulations. 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. The user profile 344 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 344 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. In some cases, 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. In some embodiments, the preferred first responder network may be an interface with an emergency calling network (e.g., 911).
[00195] The wireless gateway 340 sends the sensor data and localization data obtained from the user 336 by the wearable device 302, as well as contextual and/or environmental data obtained from the accessory devices 315, utilizing communications unit 346, which may comprise any type of transceiver for coupling the wireless gateway 340 to the rapid deployment carrying case 390 (or, in some cases, to another device such as a smartphone housed in the rapid deployment carrying case 390 or which is associated with one or more of the user 336 and the crowd of users 338, or directly 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 (e.g., utilizing the rapid deployment carrying case 390), 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 UWB, NFC, WiFi, Bluetooth, BLE, IR, modem, cellular, ZigBee, BAN, etc. The wireless gateway 340 may also be provisioned with contextual analysis module 347 and sensor data reconstruction module 349, which provide functionality similar to that of the contextual analysis module 334 and the sensor data reconstruction module 339, respectively.
[00196] 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, in some embodiments, 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 uniquely paired with the user 336, and which allows rapid onboarding of wearable devices such as wearable device 302 to a local BAN associated with the user 336. The wireless gateway 340 is also assumed to be paired with the rapid deployment carrying case 390, and is configured for communication therewith (e.g., to act as a bridge between the BAN of the user 336 and a mesh network formed by the wireless gateway 340 and other wireless gateways associated with one or more of the users in the crowd of users 338.
[00197] The wireless gateway 340 includes a wearable device module 342 and accessory device module 343 that provide software programs or computer instructions for providing various functionality of the wireless gateway 340. Although not shown in FIG. 3C, 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, the accessory device module 343, and the contextual analysis module 347. Such functionality may include, for example, wirelessly pairing the wearable device 302 and one or more of the accessory devices 315 in a BAN associated with the user 336. Such functionality may also include receiving the sensor data and the localization data from the wearable device 302 and the contextual and/or environmental data from the accessory devices 315 via the communications unit 346, and possibly performing a preliminary analysis of the sensor data, the localization data and the contextual and/or environmental 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 and the accessory device module 343 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. In other embodiments, the wearable device 302 functions as a pass-through entity and does not perform such preliminary analysis. Instead, 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 and the contextual and/or environmental data obtained from the accessory devices 315, to the rapid deployment carrying case 390 and/or the Al wearable device network 348 over network 384 as a pass-through entity.
[00198] Regardless of whether or not the wireless gateway 340 performs such preliminary analysis, the wearable device module 342 and the accessory device module 343 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 from the Al wearable device network 348, etc. At least a portion of the received information is based on analysis of the sensor data, the localization data, the user profile 344, the contextual and/or environmental data, or information derived therefrom previously provided by the wireless gateway 340 to the rapid deployment carrying case 390 and/or 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, one or more of the accessory devices 315, or another type of local or remote indicator device.
[00199] The wearable device module 342 and/or the accessory device module 343 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 utilizing the wearable device 302 and/or one or more of the accessory devices 315 or other devices. The notification settings, in some embodiments, may specify the types of indicator devices that are part of or otherwise accessible to the wearable device 302 and/or the accessory devices 315 for delivering notifications to the user 336 (or to a doctor, nurse, physical therapist, medical assistant, caregiver, 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, as detailed above, may include physical stimulus (e.g., electrical, thermal, vibrational, pressure, stroking, a combination thereof, or the like), optical stimulus, acoustic stimulus, etc. In some embodiments, notifications may be delivered to remote terminals or devices other than the wearable device 302 and/or the accessory devices 315 associated with user 336. For example, 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.
[00200] 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).
[00201] 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, such as one or more of the accessory devices 315. 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. It should be understood that the term “remote” in this context does not necessarily indicate any particular physical distance from the user 336. For example, a remote device to which notifications are delivered may be in the same room as the user 336. The term “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, first responder, squad leader, etc.).
[00202] 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, first responder, squad leader, etc. associated with the user 336). In some embodiments, 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. More generally, 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, first responder, squad leader, etc. associated with the user 336).
[00203] 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 and/or accessory devices to the rapid deployment carrying case 390 and/or the Al wearable device network 348, possibly via respective wireless gateways. The wearable devices, accessory 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, the accessory devices 315, and the wireless gateway 340 associated with the user 336.
[00204] It should be appreciated that although the wearable device 302 may be configured with multiple different types of sensors 316-329, it is generally not possible to configure a wearable device with every possible sensor that may be needed in different scenarios. For example, wearable devices are advantageously designed for comfortable wear and use, and thus may require a small form factor which cannot accommodate the possible range of sensors and sensor types which may be needed in different scenarios. Further, some types of sensors are large, heavy and/or expensive, and thus are not conducive to being incorporated as part of a wearable device. Nonetheless, different tasks may benefit from the use of contextual and/or environmental information which may be provided using sensor types that are not available in the wearable device 302.
[00205] Consider, as an example, a scenario in which the local monitoring environment 301 where the user 336 is located is one with possible radiation exposure where dosimeter sensors would be advantageous (e.g., for correlating changes in physiologic parameters obtained from the sensing unit 314 of the wearable device 302 with knowledge of an amount and/or type of radiation that the user 336 is exposed to). The wearable device 302 may not be configured with dosimeter sensors, as this may not be practical (e.g., due to the size, power, material and other requirements) or such a potential use case is not expected to come up very often. When the need arises for radiation exposure information, accessory sensing devices 315 that include dosimeter sensors may be leveraged to provide such information which is used for contextual analysis (e.g., implemented by the contextual analysis module 334 on the wearable device 302, on the contextual analysis module 347 of the wireless gateway 340, on a contextual analysis module 367 of the Al wearable device network 348, on contextual analysis modules implemented by the accessory devices 315 and/or one or more of the third-party networks 368, etc.).s
[00206] The accessory sensing devices 315 may also or alternatively be used to determine the user 336’ s microenvironmental exposure to light, noise, temperature, humidity, pressure, etc. These and other factors can influence different aspects of the microenvironment of the user 336 which can be correlated with physiologic data obtained from the user 336 via the sensing unit 314 of the wearable device 302. This may include use cases such as impact/fall detection, detecting fatigue of the user 336, etc. Another use case is in determining a “wet-bulb” temperature of the user 336. The wet-bulb temperature of the user 336, which may be determined from microenvironmental monitoring of information such as light, temperature, humidity and pressure, can be correlated with measured physiologic data to determine harmful and potentially life-threatening conditions. Monitoring for the microenvironmental wet-bulb temperature can be useful in various scenarios, including for soldiers which may be equipped with Mission Oriented Protective Posture (MOPP) gear that is heavy and bulky, leading to the soldiers having an increased wet-bulb temperature. The microenvironmental monitoring of the wet-bulb temperature (e.g., via accessory devices 315) may be correlated with physiologic data measured from on-body sensors (e.g., from the sensing unit 314 of the wearable device 302) which characterize, for example, physical activity or exertion. This may be used to provide feedback to the user 336 (e.g., to stop the physical activity or exertion, to remove MOPP gear or other bulky equipment or clothing, etc.). In some embodiments, the microenvironmental monitoring of wet-bulb temperature may be correlated with local weather report information as well as measured physiologic data of the user 336 (e.g., to detect risk of heat exhaustion or other conditions).
[00207] The microenvironmental monitoring may also or alternatively utilize microenvironmental noise information to detect exposure to potentially harmful noise levels. This may include monitoring and detecting a microenvironmental infrasound signature, which may be correlated with physiologic data from the user 336 to characterize effects such as nausea, vomiting internal injuries (e.g., organ tearing), etc. Noise exposure information may also be used to detect microenvironmental sound signatures (e.g., to detect exposure to radiofrequency (RF), to detect drones or vehicles in the area, to detect exposure to shots fired/explosions, to detect sounds indicative of coughing, vomiting or choking events, etc.) which may be time-correlated with physiologic data from the user 336 (e.g., core vital signs indicative of being hit by a shot fired, having injuries related to a blast exposure, being sick from dehydration, vomiting, choking, etc.).
[00208] The microenvironmental information and physiologic monitoring data may be used for various types of contextual analysis, where the microenvironmental information and physiologic monitoring data are correlated with knowledge of what the user 336 is doing (e.g., whether the user 336 is awake or asleep, a physical workload or profile of the user 336, etc.). Noise information, in some cases, may be used for contextual analysis of the activity of multiple users (e.g., the user 336 and one or more of the users in the crowd of users 338) to provide spatial reference information (e.g., detecting where shots/blasts come from, where drones or vehicles are traveling, etc.). In some cases, the contextual analysis includes “friend/foe” detection, where the user 336 has a specific profile (e.g., ECG signature, tone/audio signature, etc.) which may be used to detect when the wearable device 302 associated with the user 336 is being utilized by another user (e.g., a potential “foe”).
[00209] More generally, the accessory sensing devices 315 are leveraged to provide contextual and/or environmental information which is difficult, not possible or not practical to obtain utilizing the wearable device 302 alone. This may be due to the contextual and/or environmental information only being needed in limited use cases, such that the cost of implementing the required sensor types within the wearable device 302 is not practical or cost- effective. Thus, it should be appreciated that the sensor types of the accessory devices 315 which are leveraged to obtain contextual and/or environmental information are not limited solely to sensor types which are difficult to implement within the small form factor or other constraints of the wearable device 302 (e.g., comfortable long-term wear by the user 336, cost, etc.). In some embodiments, the contextual and/or environmental information may be used in sensor data reconstruction algorithms implemented by one or more of the sensor data reconstruction module 339, the sensor data reconstruction module 349, and/or sensor data reconstruction module 369.
[00210] The Al wearable device network 348 is configured to receive data (e.g., sensor data and localization data from the wearable device 302, contextual and/or environmental data from the accessory devices 315, user profile 344, preliminary analysis of the sensor, localization and contextual and/or environmental data, etc.) from the rapid deployment carrying case 390 (or potentially, from the wireless gateway 340 associated with the user 336 or other wireless gateways associated with users in 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, occurrence of events, event classification (e.g., including detection of firearm discharges), etc. As shown in FIG. 3D, 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 military or other security module 365, a contextual analysis module 367, and a sensor data reconstruction module 369. The contextual analysis module 367 and the sensor data reconstruction module 369 are configured to provide functionality similar to that of the contextual analysis module 334 and the sensor data reconstruction module 339, respectively. 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.
[00211] In some embodiments, 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). In some embodiments, the clouds of the cloud computing platform implementing the Al wearable device network 348 are accessible via the Internet over network 384. In other embodiments, 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). In these and other embodiments, 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).
[00212] The database 366 provides a data store for information about patient conditions (e.g., information about the user 336 and crowd of users 338), information relating to diseases including epidemics or pandemics, information related to firearm discharges and the context in which such firearm discharges occurred, 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. [00213] The Al wearable device network 348 may exchange various information with third- party networks 368. As shown in FIG. 3E, the third-party networks 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, one or more military or other security networks 383, etc. Third-party networks 368 may also include telemedicine networks. For example, in some embodiments 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. Under certain circumstances, as permitted by the verification entity 386, 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, contextual analysis, sensor data reconstruction, any other tracking or intervention 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.
[00214] 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. It should be noted that, if desired, 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.). [00215] 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. [00216] 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 be utilized for monitoring user 336 and the crowd of users 338 before, during and after detection of firearm discharges. Such information, for example, may be provided to various ones of the third-party networks 368, such as the first responder networks 370, the military or other security networks 383, etc.
[00217] The location tracking module 356 is configured to track the location of user 336 and the crowd of users 338, such as 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, in some embodiments, 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), a geographic location or region associated with a natural disaster, a geographic location or region associated with exposure to radiation, toxins or other potentially harmful environmental conditions, etc. In some embodiments, 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, associated with exposure to radiation, toxins or other harmful environmental conditions, etc.) may be modified based on location of the user 336 and crowd of users 338. For example, the threshold for detecting a symptom (e.g., shortness of breath) may be lowered if the user 336 or crowd of users 338 are in high-risk locations for contracting an infectious disease. The location tracking module 356 may also be configured to track the locations of the user 336 and the crowd of users 338 before, during and after detection of firearm discharges. The tracked location may be provided to various ones of the third-party networks 368, such as the first responder networks 370, the military or other security networks 383, etc.
[00218] 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 (e.g., associated with a pandemic or other outbreak of a disease, associated with exposure to radiation, toxins or other potentially harmful environmental conditions, etc.). 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, exposure to radiation, toxins or other harmful environmental conditions, etc.).
[00219] 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.
[00220] 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.
[00221] 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.
[00222] Various ones of the pandemic response module 352, the vital monitoring module 354, the location tracking module 356, the automated contact tracing module 358, the disease progression module 360, the in-home module 362 and the essential workforce module 364 can further leverage the contextual and/or environmental data obtained from the accessory devices 315 in performing their various functionality using the contextual analysis module 367 and/or using sensor data reconstructed using the sensor data reconstruction module 369.
[00223] FIG. 3F shows a detailed view of the rapid deployment carrying case 390, which includes a computation unit 391 implementing wearable device management module 392, wireless gateway management module 393, network management module 394, and local monitoring and analysis module 395, a data storage unit 396, a communications unit 397, a power supply 398, and a display 399. The computation unit 391 may comprise at least one processing device which, together with the data storage unit 396, provides computational and data storage capability for the rapid deployment carrying case 390. The computation unit 391, for example, provides an onboard computational system that can offload data (e.g., collected from the user 336 and the crowd of users 338 using wearable devices and/or accessory devices), store data locally on the data storage unit 396, compute metrics and/or generate monitoring and treatment reports utilizing the local monitoring and analysis module 395, etc. The computation unit 391, in some embodiments, is configured to utilize the local monitoring and analysis module 395 to run a gamut of algorithms, to offload a combination of physiologic data from monitored subjects (e.g., the user 336 and crowd of users 338). The computation unit 391, for example, may utilize the local monitoring and analysis module 395 to monitor identified tasks performed by nurses, doctors, caregivers or other support staff (e.g., via one or more applications on connected smart devices) in order to document what was performed for each of the monitored subjects, and to make that available for downstream review, to store in patient or subject records, etc.
[00224] The computation unit 391 may also be configured to drive the display 399 to provide display and analysis capabilities. The display 399 may comprise a liquid crystal display (LCD) or another screen, which is programmable by the user for optimization. The computation unit 391 may drive the display 399 to output physiologic, contextual and/or environmental information associated with one or more selected users (e.g., the user 336 and/or one or more of the crowd of users 338). In some cases, this includes displaying waveforms (e.g., real-time or near real-time) which are captured by the wearable devices and/or accessory devices associated with the one or more selected users. In other cases, this includes displaying computed metrics and/or monitoring and treatment reports which are generated by the local monitoring and analysis module 395, in addition to or in place of the real-time or near realtime waveforms being captured by the wearable devices and/or accessory devices associated with the one or more selected users. It should be noted that the display 399 may be a touchscreen display, or the rapid deployment carrying case 390 may otherwise include user interface features (e.g., buttons, a keyboard, a mouse, etc.) which enable an operator to switch the selected one or more users, to switch what information is displayed for the selected one or more users. Such user interface features may also enable an operator to initiate a videoconference, a phone call or other communication link with the selected one or more users (e.g., via microphones, speakers, and/or displays of smartphones or other devices carried by the selected one or more users, via microphones, speakers and/or displays which are integrated with the wireless gateways and/or one or more sensing devices or indicator devices associated with the selected one or more users, etc.).
[00225] The communications unit 397 is configured to provide various communications functionality for the rapid deployment carrying case 390. In some embodiments, the communications unit 397 includes one or more Universal Serial Bus (USB) ports, WiFi, Bluetooth, NFC or other communication capability to offload data from wearable devices and or wireless gateways which are paired with the rapid deployment carrying case 390 to the data storage unit 396. The communications unit 397 may also include radio systems for long-range communication with remote medical facilities or other systems or devices (e.g., the Al wearable device network 348 and/or the third-party networks 368 via network 384) to offload data from the data storage unit 396. Such radio systems for long-range communication may also be used for receiving data from the remote medical facilities or other systems or devices. The communications unit 397 may also or alternatively facilitate visual and/or audio 2-way communications between the rapid deployment carrying case 390 and other devices (e.g., one or more wearable devices and/or wireless gateways which are paired with the rapid deployment carrying case 390). This may include multi-user simultaneous communication. In some embodiments, the communications unit 397 provides a video camera and/or one or more microphones and speakers for sending video and/or audio to local and remote users. The communications unit 397 may further provide for connection to any desired communication network (e.g., network 384) for data transmission. The network management module 394 of the computation unit 391 may control the communications unit 397.
[00226] The computation unit 391 further provides fleet management functionality via the wearable device management module 392 and the wireless gateway management module 393. The wearable device management module 392 provides functionality for checking the status of wearable devices which are paired or otherwise associated with (e.g., which have been deployed from) the rapid deployment carrying case 390, while the wireless gateway management module 393 provides functionality for checking the status of wireless gateways which are paired or otherwise associated with (e.g., which have been deployed from) the rapid deployment carrying case 390. The wearable device management module 392 and the wireless gateway management module 393 may also provide functionality for managing device updates for such wearable devices and wireless gateways which are paired or otherwise associated with the rapid deployment carrying case 390.
[00227] The power supply 398 comprises one or more batteries, inverters or other power supply hardware for powering the computation unit 391, the data storage unit 396, the communications unit 397 and the display 399. The power supply 398 may also be used for charging wearable devices and/or wireless gateways, to maintain these and other devices in a state of readiness for when they are deployed for use by the user 336 and the crowd of users 338 in the local monitoring environment 301. The power supply 398 may also comprise lighting functionality, and provide power for one or more lights such as hand-held work lights. [00228] Although not shown in FIG. 3F, the rapid deployment carrying case 390 may comprise a housing with various compartments for carrying and displaying various equipment, including but not limited to wearable devices including disposable sampling units and reusable sensing units such as patches and hubs/modules, wireless gateways, other devices for handling emergent and non-emergent medical problems, etc. Such other devices may include, for example, hand tools such as clamps, clips, scissors, probes, forceps, towel clips, suture necessities, etc.
[00229] FIGS. 4 A and 4B show a rapid care delivery deployment kit, including a rapid deployment carrying case 400. FIGS. 4A and 4B show different isometric views of the rapid deployment carrying case 400 with a top lid open. The rapid deployment carrying case 400 includes a housing with a number of compartments. In a first compartment in the top lid of the housing of the rapid deployment carrying case 400, a plurality of hubs 405 are mounted on respective hub mounts. In a second compartment of the housing of the rapid deployment carrying case 400, a plurality of wireless gateways 410 are mounted in respective gateway mounts. The housing of the rapid deployment carrying case 400 also includes a power supply and computer 415 mounted along an edge of the second compartment on one side of the housing. A touchscreen display 420 is mounted to a top of the power supply and computer 415. The power supply and computer 415 may include one or more batteries and inverters for a power system powering the computer, communications hardware included in the computer, the touchscreen display 420, charging the hubs 405 and/or wireless gateways 410, etc. A number of smart devices 425 (e.g., smartphones) are held in pockets along other edges of the second compartment on other sides of the housing of the rapid deployment carrying case 400. The rapid deployment carrying case 400 also includes wheels 430 and a handle 435, which facilitates movement of the rapid deployment carrying case 400 in a manner similar to that of a travel suitcase. FIG. 4A further shows an accessory bag 440 which may be stored in the second compartment of the housing of the rapid deployment carrying case 400. The accessory bag 440 may be one of multiple accessory bags which are stored in the second compartment of the housing of the rapid deployment carrying case 400. The accessory bag 440 may store various items, such as patches, patient prep supplies, cleaning supplies, etc.
[00230] It should be noted that, in some embodiments, the hubs 405 and gateways 410 may be combined (e.g., a single device may provide the functionality of a hub and a gateway). For example, one or more of the gateways 410 may include computational resources, memory, sensors, a plurality of radios (e.g., short and long-range radios), etc.
[00231] The hubs 405 (also referred to as modules 405) are configured for placement on a subject. Each of the hubs or modules 405 includes one or more sensors configured for performing various functionality. The sensors, for example, may include audio channels for communication (which may also or alternatively include speakers or other audio channels on the wireless gateways 410) and physiological monitoring sensors (e.g., for monitoring vitals such as heart rate, respiration, ECG, temperature, limb tissue perfusion, end-tidal carbon dioxide (ETCO2), blood pressure including arterial, central or other blood pressures, blood oxygenation saturation (SpO2), EEG, alertable metrics such as shock, bleeding, low blood oxygen levels, low temperature, cardiac arrythmias, respiratory changes, cardiac arrest, seizures, etc.). The hubs 405 and/or wireless gateways 410 may include one or more algorithms to determine a state of a subject, to generate one or more alerts based on the determined state of the subject, etc. By way of example, the algorithms may provide functionality for detecting early signs of hypovolemic shock, ventricular fibrillation, hemorrhage, loss of consciousness, choking, changes in respiratory status, etc.
[00232] The rapid deployment carrying case 400 has a housing with a top lid that is hinged to optimize display of the contents thereof. The rapid deployment carrying case 400 provides various functionality, including carrying and holding the hubs 405 and wireless gateways 410 which simplifies deployment of such devices in a local monitoring environment. The housing of the rapid deployment carrying case 400 may include a ballistic covering with interior padding and various straps to prevent damage if the rapid deployment carrying case 400 is dropped or subject to trauma. In some embodiments, the rapid deployment carrying case 400 may include additional sensors (e.g., ETCO2, blood pressure, SpO2, EEG, etc.).
[00233] The power supply and computer 415 of the rapid deployment carrying case 400 is able to encode any signal (e.g., obtained from paired ones of the hubs 405 and/or wireless gateways 410) for distant transmission, for display on the integrated touchscreen display 420 or another compatible monitor or other computing device such as one or more of the smartphones 425. The touchscreen display 420 may include an LCD or other screen which is programmable by a user for optimization, and which may display waveforms (e.g., switchable across any or all signals captured from the hubs 405 and/or wireless gateways 410, numerical analysis, etc.). The power supply and computer 415 may also include communications hardware, such as a speaker/microphone for voice over IP (VOIP) or other audio 2-way communications enabling multi-user simultaneous conversation. The communications hardware may further comprise a video camera for sending video or still frames to and from local and remotely connected users. The communications hardware is also configured for enabling connection to various different types of communication networks for transmission of data from the hubs 405 and/or wireless gateways 410 to external networks. Such data may include any encoded signals for distant transmission to external networks for further analysis, for display on compatible monitors or displays, etc. Such encoded signals may communicate various status or state of subjects, including but not limited to: bleeding that will not stop; breathing problems (e.g., difficulty breathing, shortness of breath, etc.); changes in mental status (e.g., unusual behavior, confusion, difficulty arousing, etc.); chest pain or discomfort lasting for at least a designated threshold length of time (e.g., two minutes or more); choking; coughing up or vomiting blood; weak or ineffective coughing; fainting or loss of consciousness; feeling of committing suicide or murder; head or spine injury; severe or persistent vomiting; sudden injury due to a motor vehicle accident, burns or smoke inhalation, near drowning, a deep or large wound, or other injuries; sudden, severe pain anywhere in the body; sudden dizziness, weakness, or change in vision; swallowing a poisonous substance; severe abdominal pain or pressure; unusual headache; inability to speak; swelling of the face, eyes, or tongue; bluish skin color (e.g., cyanosis). For children, the encoded signals may communicate various status or state of subjects, including but not limited to: significant changes in mental status (e.g., unusual behavior, confusion, irritability, etc.); lack of alertness or diminished response; increased sleepiness; unable to stand or walk; trouble or abnormal breathing; difficulty in eating or feeding; bluish or grey coloration of the skin (e.g., cyanosis); seizure; fever followed by a change in mental status, stiffness in the neck or back; unstoppable bleeding; etc.
[00234] The rapid deployment carrying case 400 includes a compartment for carrying and displaying medical equipment for all desired emergent and non-emergent medical problems. The medical equipment may include, for example, hand tools such as clamps, clips, scissors, probes, forceps, towel clips, suture necessities, etc. housed in one or more instances of the accessory bag 440. The rapid deployment carrying case 400 may also include miscellaneous storage content (e.g., for magnifying glasses, dressings, disinfectants, etc., which may be held in one or more instances of the accessory bag 440 or various sub-compartments of a housing of the rapid deployment carrying case 400.
[00235] In some embodiments, the rapid deployment carrying case 400 includes medical equipment for providing therapeutic capabilities (e.g., via the hub 405 or other devices). Such therapeutic capabilities may include defibrillation/cardioversion (e.g., synchronized or unsynchronized), pacing (e.g., transcutaneous/transvascular, multi-mode), etc. [00236] Rapid care delivery deployment kits may provide systems which are useful for any role in the care pathway. FIG. 5 shows a table 500 illustrating different notional United States Military Roles of medical care across different armed services branches. Devices in rapid care delivery deployment kits (e.g., sensing devices, wireless gateways, rapid deployment carrying case, etc.) can be handed off seamlessly between roles and networks. One of more devices in a rapid care delivery deployment kit may allow for tracking between facilities or monitoring sites, for planning purposes with in-route patients. This allows for seamless management of subjects through the different medical care roles, and allows surgical teams and other downstream roles to plan for incoming subjects. The devices in a rapid care delivery deployment kit are configured to retain subject records, so data is always available with the subject regardless of whether a long-range network is available or not. The devices in a rapid care delivery deployment kit may automatically integrate with other medical care applications and systems, such as Battlefield assisted trauma distributed observation kit (BATDOK), MedHub, Interoperable Medical Automated Systems (iMAS), etc.
[00237] FIGS. 6 A and 6B show a monitoring environment 600 including subjects 601-1 through 601-11 (collectively, subjects 601) each associated with one or more wearable devices 610-1 through 610-11 (collectively, wearable devices 610) and a wireless gateway 612-1 through 612-11 (collectively, wireless gateway 612). As shown in FIG. 6B, the monitoring environment 600 also includes a standalone access point 613 (e.g., which may be embodied as a rapid carrying case of a rapid care delivery deployment kit). The wireless gateways 612 and the standalone access point 613 are used to establish a mesh network among the subjects 601, and provide connectivity in this example to a third-party network 650 (e.g., a government network or another type of third-party network) and an Al wearable device network 655 (e.g., the Al wearable device network 348). The mesh network allows for providing data about one or more of the subjects 601 to medics, nurses, surgeons, other support staff, etc. associated with one or both of the third-party network 650 and the Al wearable device network 655. The mesh network illustratively has full duplex capability so that the third-party network 650 and/or the Al wearable device network 655 can communicate with any of the subjects 601. The standalone access point 613 provides a gateway mesh which can be used for ones of the subjects 601 which otherwise do not have a good connection to other nodes in the mesh network and which have no, poor or limited wide area network (WAN) connectivity to the third-party network 650 and/or the Al wearable device network 655. The gateway mesh may also be used to establish and track locations of the subjects 601, so that first responders or other support staff can move very quickly to ones of the subjects 601 in need. As an example, for search and rescue applications, injured ones of the subjects 601 may be tagged for monitoring, and the standalone access point 613 and/or one or more of the wireless gateways 612 provide communications functionality and location tracking for rapid recovery and extraction of the injured ones of the subjects 601. As another example, a facility use case may be used to track the locations of subjects within a facility (e.g., a data center, a factory, an office complex, etc.). As another example, an operational or training communications use case may involve a group of subjects (e.g., soldiers) which are performing training exercises, combat drills, etc.
[00238] In the example of FIGS. 6 A and 6B, the mesh network includes a number of different network types. Each of the subjects 601 has its own BAN connection between that subject’s wearable devices 610 and that subject’s one of the wireless gateways 612. The BAN connection may, comprise, for example, a Bluetooth Low Energy (BLE) connection, an Ultrawideband (UWB) connection, etc. The wireless gateways 612 may offload data captured by the wearable devices 610, or reports and/or metrics generated or derived therefrom to the third-party network 650 and/or the Al wearable device network 655. The wireless gateways 612, in some embodiments, store such data until a connection may be established with a mesh WAN. Individual ones of the wireless gateways 612, in some embodiments, may only join the mesh WAN when local storage of the wireless gateways 612 are full (e.g., such that data need to be offloaded), when the wireless gateways 612 locally derive reports or metrics from captured physiologic monitoring data which trigger notification thresholds (e.g., which indicate that the associated subjects 601 are in need of medical or other assistance), etc. The mesh WAN, in some embodiments, comprises any combination of Lora, UWB, BLE and WiFi mesh network connections.
[00239] The mesh WAN may be established between any of the subjects 601 which are within range of one another, regardless of whether such subjects 601 have poor or good cellular connectivity to a cellular WAN which interconnects to the third-party network 650 and/or the Al wearable device network 655. Ones of the subjects 601 whose associated wireless gateways 612 having good cellular connectivity to the cellular WAN (e.g., a Long Term Evolution (LTE) cellular network, a 5G network, etc.) are interconnected with the third-party network 650 and/or the Al wearable device network 655. In the example of FIGS. 6A and 6B, the wireless gateways 612-1, 612-4, 612-5, 612-7 and 612-8 associated with the subjects 601-1, 601-4, 601- 5, 601-7 and 601-8 have good cellular connectivity and are interconnected via the cellular WAN to one or both of the third-party network 650 and the Al wearable device network 655. The wireless gateways 612-2, 612-3, 612-6, 612-9, 612-10 and 612-11 associated with the subjects 601-2, 601-3, 601-6, 601-9, 601-10 and 601-11 have poor cellular connectivity and are not connected to the cellular WAN. Instead, the wireless gateways 612-2, 612-3, 612-6, 612-9, 612-10 and 612-11 share data via the mesh WAN to other ones of the wireless gateways 612-1, 612-4, 612-5, 612-7 and 612-8 and/or the standalone access point 613 which do have good cellular connectivity and are connected to the cellular WAN.
[00240] An exemplary process 700 for utilizing a rapid care delivery deployment physiologic monitoring kit will now be described with reference to the flow diagram of FIG. 6. It should be understood, however, that this particular process is only an example and that other types of processes for utilizing rapid care delivery deployment physiologic monitoring kits may be used in other embodiments as described elsewhere herein. The process 700 includes steps 702 through 708. The process 700 may be performed, for example by a computation unit of a carrying case of a physiologic monitoring kit.
[00241] In step 702, pairing of respective ones of a plurality of deployable devices of a physiologic monitoring kit with one or more subjects is managed. The deployable devices may comprise, for example, sensing devices, gateway devices, smart devices, etc. In some cases, a single device may provide the functionality of a sensing device and a gateway device, or any combination of sensing, gateway and smart devices. The gateway devices may be paired with the subjects, and the sensing devices may be paired with ones of the gateway devices. At least a given one of the sensing devices may comprise a reusable component and a disposable component, wherein at least one compartment of a housing of the carrying case of the physiologic monitoring kit comprising a first compartment comprising at least one mount for attachment of the reusable component and a second compartment for storage of the disposable component.
[00242] In some embodiments, ones of the deployable devices which are smart devices (e.g., smartphones) may be used to assist in assigning and pairing the deployable devices to subjects in step 702. The pairing of step 702 may utilize Near Field Communication (NFC)-based pairing, where ones of the deployable devices (e.g., gateway devices) pair with an NFC identifier (ID) on each subject. The NFC ID for a subject may be embodied as or integrated in a dog-tag, a wristband, etc. In some embodiments, NFC-based tap pairing of gateway devices to smart devices is used, so that a nurse, doctor, caregiver or other support staff can just “tap” a gateway device with his or her smart device (e.g., smartphone), and patient/subject data is sent from the gateway device to the smart device thus enabling that nurse, doctor, caregiver or other support staff to work on a patient or subject associated with the gateway device. The patient/subject data on one or both of the smart device and the gateway device may be updated with a record of actions taken by the nurse, doctor, caregiver or other support staff. This record of actions, which may be entered via one or more applications running on the smart device, may be transferred to the gateway device and stored therein and may be accessed by other users when the patient/subject is moved onward in a process.
[00243] In step 704, a mesh network for a local monitoring environment wherein at least one of the paired ones of the plurality of deployable devices of the physiologic monitoring kit has been deployed is joined via a communications unit of the carrying case of the physiologic monitoring kit. The deployable devices which have been deployed in the local monitoring environment may automatically establish the mesh network, and the carrying case of the physiologic monitoring kit may join the mesh network. In some cases, the carrying case of the physiologic monitoring kit provides a network exit point (e.g., to an external system outside the local monitoring environment) for data that is communicated within the mesh network.
[00244] In step 706, physiologic monitoring data associated with at least one of the one or more subjects is obtained via the mesh network from at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment. The mesh network may be formed on one or more physical layers, each physical layer comprising a range of frequency bands, upon which data can be transferred. The mesh network may comprise at least one mesh protocol based on a long range evolution schema, an ultrawideband (UWB) mesh protocol, a Bluetooth Low Energy (BLE) mesh protocol, a WiFi mesh protocol, a HaLow mesh protocol, a private 5G mesh protocol, or the like. The mesh network of devices may be configured to use time of flight (TOF), time difference of arrival (TDoA), and phase difference of arrival (PDoA) technologies, or the like to enable extremely accurate (e.g., within a centimeter) distance and location tracking and two-way ranging capabilities between subjects in the network. The smart devices may be equipped with applications (e.g., the Android Tactical Awareness Kit (ATAK), iTAK, Kill Switch, winTAK, or the like) in order to visualize such location-based relationships between the devices. The computation unit of the carrying case may be further configured to utilize the communications unit to establish a data link, distinct from the mesh network, with at least one external system outside the local monitoring environment. The at least one external system may comprise a remote medical facility. The data link may comprise a cellular network connection, the cellular network connection comprising at least one of a very high frequency (VHF), ultra high frequency (UHF) long-range radio connection, a tactical radio network connection, a Long- Term Evolution (LTE) cellular wide area network (WAN), and a 5G cellular WAN. The computation unit of the carrying case of the physiologic monitoring kit may be further configured to provide at least a portion of the obtained physiologic monitoring data or at least a portion of the information generated therefrom to the at least one external system via the data link. The carrying case of the physiologic monitoring kit may further comprise a data storage unit comprising one or more storage devices, and the computation unit of the carrying case of the physiologic monitoring kit may be further configured to store at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit. The storage of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit may be performed responsive to the computation unit being unable to establish, via the communications unit, a data link with the at least one external system outside the local monitoring environment.
[00245] In step 708, output of at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of information generated therefrom on a display unit of the carrying case of the physiologic monitoring kit is controlled. The at least one display of the display unit may comprise a touchscreen display, and wherein the computation unit of the carrying case of the physiologic monitoring kit may be configured to provide, via the touchscreen display, user interface features enabling dynamic selection of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom to output on the display unit. The dynamic selection may be between two or more different ones of the one or more subjects, between the portion of the obtained physiologic monitoring data and the portion of the information generated therefrom, between two or more different portions of the obtained physiologic monitoring data and two or more different portions of the information generated therefrom, combinations thereof, etc. The information generated from at least a portion of the obtained physiologic monitoring data may comprise one or more monitoring or treatment reports for at least one of the one or more subjects.
[00246] The carrying case of the physiologic monitoring kit may comprise one or more lights configured for illuminating at least a portion of at least one compartment of a housing of the carrying case in which the plurality of sensing devices and the plurality of gateway devices are stored.
[00247] The carrying case of the physiologic monitoring kit may comprise a power supply unit comprising at least one power supply, the power supply unit being configured for powering the computation unit, the communications unit and the display unit, and the one or more lights of the carrying case. The power supply unit may be further configured to charge at least one of the plurality of deployable devices.
[00248] The communications unit of the carrying case of the physiologic monitoring kit may comprise at least one microphone and at least one speaker, and the computation unit of the carrying case of the physiologic monitoring kit may be configured to establish a two-way audio communication channel utilizing the communications unit. The two-way audio communication channel may be established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
[00249] The communications unit of the carrying case of the physiologic monitoring kit may comprise at least one camera, and the computation unit of the carrying case of the physiologic monitoring kit may be configured to establish a two-way video communication channel utilizing the communications unit and the display unit. The two-way video communication channel may be established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
[00250] The computation unit of the carrying case of the physiologic monitoring kit may be further configured to monitor a device state of at least one of the plurality of deployable devices, to manage device updates for at least one of the plurality of deployable devices, combinations thereof, etc.
[00251] It will be appreciated that additional advantages and modifications will readily occur to those skilled in the art. Therefore, the disclosures presented herein and broader aspects thereof are not limited to the specific details and representative embodiments shown and described herein. Accordingly, many modifications, equivalents, and improvements may be included without departing from the spirit or scope of the general inventive concept as defined by the appended claims and their equivalents.

Claims

Claims What is claimed is:
1. A physiologic monitoring kit comprising: a carrying case comprising: a computation unit comprising at least one processing device comprising a processor coupled to a memory; a communications unit comprising at least one network interface; a display unit comprising at least one display; a housing comprising at least one compartment; and a power supply unit comprising at least one power supply, the power supply unit being configured to power the computation unit, the communications unit and the display unit; and a plurality of deployable devices housed in the at least one compartment; and the computation unit being configured: to manage pairing of respective ones of the plurality of deployable devices with one or more subjects; to join, via the communications unit, a mesh network for a local monitoring environment wherein at least one of the paired ones of the plurality of deployable devices has been deployed; to obtain, via the mesh network, physiologic monitoring data associated with at least one of the one or more subjects from at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment; and to control output of at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of information generated therefrom on the display unit.
2. The physiologic monitoring kit of claim 1, wherein the carrying case further comprises one or more lights, the one or more lights being configured for illuminating at least a portion of the at least one compartment.
3. The physiologic monitoring kit of claim 1, wherein the power supply unit is further configured to charge at least one of the plurality of deployable devices.
4. The physiologic monitoring kit of claim 1, wherein the plurality of deployable devices comprise one or more gateway devices, one or more sensing devices configured for pairing with the one or more gateway devices, and one or more smart devices.
5. The physiologic monitoring kit of claim 4, wherein at least a given one of the one or more sensing devices comprises a reusable component and a disposable component, the at least one compartment comprising a first compartment comprising at least one mount for attachment of the reusable component and a second compartment for storage of the disposable component.
6. The physiologic monitoring kit of claim 1, wherein the mesh network is formed on one or more physical layers, each of the one or more physical layers comprising a range of frequency bands upon which data can be transferred, and wherein the mesh network utilizes at least one mesh protocol based on at least one of a long range (LoRa) evolution schema, an ultrawideband (UWB) mesh protocol, a Bluetooth Low Energy (BLE) mesh protocol, a WiFi mesh protocol, a HaLow mesh protocol, and a private 5G mesh protocol.
7. The physiologic monitoring kit of claim 1, wherein the computation unit is further configured to utilize the communications unit to establish a data link, distinct from the mesh network, with at least one external system outside the local monitoring environment.
8. The physiologic monitoring kit of claim 7, wherein the at least one external system comprises a remote medical facility.
9. The physiologic monitoring kit of claim 7, wherein the data link comprises a cellular network connection, the cellular network connection comprising at least one of a very high frequency (VHF), ultra high frequency (UHF) long-range radio connection, a tactical radio network connection, a Long-Term Evolution (LTE) cellular wide area network (WAN), and a 5G cellular WAN.
10. The physiologic monitoring kit of claim 7, wherein the computation unit is further configured to provide at least a portion of the obtained physiologic monitoring data or at least a portion of the information generated therefrom to the at least one external system via the data link.
11. The physiologic monitoring kit of claim 1, wherein the carrying case further comprises a data storage unit comprising one or more storage devices, and wherein the computation unit is further configured to store at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit.
12. The physiologic monitoring kit of claim 11, wherein the storage of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit is performed responsive to the computation unit being unable to establish, via the communications unit, a data link with the at least one external system outside the local monitoring environment.
13. The physiologic monitoring kit of claim 1, wherein the at least one display of the display unit comprises a touchscreen display, and wherein the computation unit is configured to provide, via the touchscreen display, user interface features enabling dynamic selection of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom to output on the display unit.
14. The physiologic monitoring kit of claim 13, wherein the dynamic selection is between two or more different ones of the one or more subjects.
15. The physiologic monitoring kit of claim 13, wherein the dynamic selection is between the portion of the obtained physiologic monitoring data and the portion of the information generated therefrom.
16. The physiologic monitoring kit of claim 13, wherein the dynamic selection is between two or more different portions of the obtained physiologic monitoring data and two or more different portions of the information generated therefrom.
17. The physiologic monitoring kit of claim 1, wherein the computation unit is further configured to generate one or more monitoring reports for at least one of the one or more subjects based at least in part on the obtained physiologic monitoring data, and wherein said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom that is output on the display unit comprises at least one of the one or more monitoring reports.
18. The physiologic monitoring kit of claim 1, wherein the computation unit is further configured to generate one or more treatment reports for at least one of the one or more subjects based at least in part on the obtained physiologic monitoring data, and wherein said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom that is output on the display unit comprises at least one of the one or more treatment reports.
19. The physiologic monitoring kit of claim 1, wherein the communications unit comprises at least one microphone and at least one speaker, and wherein the computation unit is configured to establish a two-way audio communication channel utilizing the communications unit.
20. The physiologic monitoring kit of claim 19, wherein the two-way audio communication channel is established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
21. The physiologic monitoring kit of claim 1, wherein the communications unit comprises at least one camera, and wherein the computation unit is configured to establish a two-way video communication channel utilizing the communications unit and the display unit.
22. The physiologic monitoring kit of claim 21, wherein the two-way video communication channel is established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
23. The physiologic monitoring kit of claim 1, wherein the computation unit is further configured to monitor a device state of at least one of the plurality of deployable devices.
24. The physiologic monitoring kit of claim 1, wherein the computation unit is further configured to manage device updates for at least one of the plurality of deployable devices.
25. The physiologic monitoring kit of claim 1, further comprising medical equipment utilizable for treating the one or more subjects housed in the at least one compartment.
26. The physiologic monitoring kit of claim 25, wherein the medical equipment comprises at least one of one or more clamps, one or more clips, one or more scissors, one or more probes, one or more forceps, one or more towel clips, and one or more suture necessities.
27. A carrying case comprising: a computation unit comprising at least one processing device comprising a processor coupled to a memory; a communications unit comprising at least one network interface; a display unit comprising at least one display; a housing comprising at least one compartment; and a power supply unit comprising at least one power supply, the power supply unit being configured to power the computation unit, the communications unit and the display unit; and the computation unit being configured: to manage pairing of respective ones of a plurality of deployable devices with one or more subjects; to join, via the communications unit, a mesh network for a local monitoring environment wherein at least one of the paired ones of the plurality of deployable devices has been deployed; to obtain, via the mesh network, physiologic monitoring data associated with at least one of the one or more subjects from at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment; and to control output of at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of information generated therefrom on the display unit.
28. The carrying case of claim 27, further comprising one or more lights, the one or more lights being configured for illuminating at least a portion of the at least one compartment.
29. The carrying case of claim 27, wherein the power supply unit is further configured to charge at least one of the plurality of deployable devices.
30. The carrying case of claim 27, wherein the plurality of deployable devices comprise one or more gateway devices, one or more sensing devices configured for pairing with the one or more gateway devices, and one or more smart devices.
31. The carrying case of claim 27, wherein the computation unit is further configured to utilize the communications unit to establish a data link, distinct from the mesh network, with at least one external system outside the local monitoring environment.
32. The carrying case of claim 31, wherein the computation unit is further configured to provide at least a portion of the obtained physiologic monitoring data or at least a portion of the information generated therefrom to the at least one external system via the data link.
33. The carrying case of claim 27, further comprising a data storage unit comprising one or more storage devices, wherein the computation unit is further configured to store at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit.
34. The carrying case of claim 33, wherein the storage of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit is performed responsive to the computation unit being unable to establish, via the communications unit, a data link with the at least one external system outside the local monitoring environment.
35. The carrying case of claim 27, wherein the at least one display of the display unit comprises a touchscreen display, and wherein the computation unit is configured to provide, via the touchscreen display, user interface features enabling dynamic selection of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom to output on the display unit.
36. The carrying case of claim 27, wherein the computation unit is further configured to generate one or more monitoring or treatment reports for at least one of the one or more subjects based at least in part on the obtained physiologic monitoring data, and wherein said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom that is output on the display unit comprises at least one of the one or more monitoring or treatment reports.
37. The carrying case of claim 27, wherein the communications unit comprises at least one microphone and at least one speaker, and wherein the computation unit is configured to establish a two-way audio communication channel utilizing the communications unit.
38. The carrying case of claim 37, wherein the two-way audio communication channel is established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
39. The carrying case of claim 27, wherein the communications unit comprises at least one camera, and wherein the computation unit is configured to establish a two-way video communication channel utilizing the communications unit and the display unit.
40. The carrying case of claim 39, wherein the two-way video communication channel is established with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
41. The carrying case of claim 27, wherein the computation unit is further configured to monitor a device state of at least one of the plurality of deployable devices.
42. The carrying case of claim 27, wherein the computation unit is further configured to manage device updates for at least one of the plurality of deployable devices.
43. A method compri sing : managing, utilizing a computation unit of a carrying case of a physiologic monitoring kit, pairing of respective ones of a plurality of deployable devices of the physiologic monitoring kit with one or more subjects; joining, via a communications unit of the carrying case of the physiologic monitoring kit, a mesh network for a local monitoring environment wherein at least one of the paired ones of the plurality of deployable devices has been deployed; obtaining, via the mesh network, physiologic monitoring data associated with at least one of the one or more subjects from at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment; and controlling output, on a display unit of the carrying case of the physiologic monitoring kit, of at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of information generated therefrom.
44. The method of claim 43, further comprising establishing, via the communications unit of the carrying case of the physiologic monitoring kit, a data link distinct from the mesh network with at least one external system outside the local monitoring environment.
45. The method of claim 44, further comprising providing, via the data link, at least a portion of the obtained physiologic monitoring data or at least a portion of the information generated therefrom to the at least one external system.
46. The method of claim 43, further comprising storing at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in a data storage unit of the carrying case of the physiologic monitoring kit.
47. The method of claim 46, wherein the storage of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit is performed responsive to the computation unit of the carrying case of the physiologic monitoring kit being unable to establish, via the communications unit of the carrying case of the physiologic monitoring kit, a data link with the at least one external system outside the local monitoring environment.
48. The method of claim 43, further comprising establishing, utilizing the communications unit of the carrying case of the physiologic monitoring kit, a two-way audio communication channel with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
49. The method of claim 43, further comprising establishing, utilizing the communications unit and the display unit of the carrying case of the physiologic monitoring kit, a two-way video communication channel with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
50. A computer program product comprising a non-transitory processor-readable storage medium having stored therein executable program code which, when executed, causes a computation unit of a carrying case of a physiologic monitoring kit: to manage pairing of respective ones of a plurality of deployable devices of the physiologic monitoring kit with one or more subjects; to join, via a communications unit of the carrying case of the physiologic monitoring kit, a mesh network for a local monitoring environment wherein at least one of the paired ones of the plurality of deployable devices o has been deployed; to obtain, via the mesh network, physiologic monitoring data associated with at least one of the one or more subjects from at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment; and to control output, on a display unit of the carrying case of the physiologic monitoring kit, of at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of information generated therefrom.
51. The computer program product of claim 50, wherein the executable program code, when executed, further causes the computation unit of the carrying case of the physiologic monitoring kit to establish, via the communications unit of the carrying case of the physiologic monitoring kit, a data link distinct from the mesh network with at least one external system outside the local monitoring environment.
52. The computer program product of claim 51, wherein the executable program code, when executed, further causes the computation unit of the carrying case of the physiologic monitoring kit to provide, via the data link, at least a portion of the obtained physiologic monitoring data or at least a portion of the information generated therefrom to the at least one external system.
53. The computer program product of claim 50, wherein the executable program code, when executed, further causes the computation unit of the carrying case of the physiologic monitoring kit to store at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in a data storage unit of the carrying case of the physiologic monitoring kit.
54. The computer program product of claim 53, wherein the storage of said at least one of at least a portion of the obtained physiologic monitoring data and at least a portion of the information generated therefrom in the data storage unit is performed responsive to the computation unit of the carrying case of the physiologic monitoring kit being unable to establish, via the communications unit of the carrying case of the physiologic monitoring kit, a data link with the at least one external system outside the local monitoring environment.
55. The computer program product of claim 50, wherein the executable program code, when executed, further causes the computation unit of the carrying case of the physiologic monitoring kit to utilize the communications unit of the carrying case of the physiologic monitoring kit to establish a two-way audio communication channel with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
56. The computer program product of claim 50, wherein the executable program code, when executed, further causes the computation unit of the carrying case of the physiologic monitoring kit to utilize the communications unit of the carrying case of the physiologic monitoring kit to establish a two-way video communication channel with at least one of the paired ones of the plurality of deployable devices which has been deployed in the local monitoring environment.
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