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WO2022076681A1 - Système et procédé de de détermination de respect d'utilisation de substances illicites - Google Patents

Système et procédé de de détermination de respect d'utilisation de substances illicites Download PDF

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Publication number
WO2022076681A1
WO2022076681A1 PCT/US2021/053966 US2021053966W WO2022076681A1 WO 2022076681 A1 WO2022076681 A1 WO 2022076681A1 US 2021053966 W US2021053966 W US 2021053966W WO 2022076681 A1 WO2022076681 A1 WO 2022076681A1
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WO
WIPO (PCT)
Prior art keywords
patch
bodily fluid
individual
processor
sweat
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2021/053966
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English (en)
Inventor
Steve Carl MOAK
Steve Henry MOAK
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
True Mobile Health LLC
Original Assignee
True Mobile Health LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by True Mobile Health LLC filed Critical True Mobile Health LLC
Publication of WO2022076681A1 publication Critical patent/WO2022076681A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/0064—Devices for taking samples of body liquids for taking sweat or sebum samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A61B5/02055—Simultaneously evaluating both cardiovascular condition and temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4845—Toxicology, e.g. by detection of alcohol, drug or toxic products
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7225—Details of analogue processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B2010/0009—Testing for drug or alcohol abuse

Definitions

  • Appendix A (2 pages) is a publicly available product sheet from Conductive Technologies for Phase Zero Sensors that is part of the specification;
  • Appendix B (11 pages) is a public article entitled “A Four Channel Electrical Impedance Spectroscopy Module for Cortisol Biosensing in Sweat-Based Wearable Applications” by Sankhala et al. that is part of the specification;
  • Appendix C (7 pages) is a public article entitled “A Novel Capacitive Sensor Based on Molecularly Imprinted Nanoparticles as Recognition Elements” by Canfarotta et al. that is part of the specification.
  • the disclosure relates to a system and method for measuring illicit substance use and reporting compliance and in particular to a system and method for measuring drug and alcohol use and enforcing compliance with a no drug and/or alcohol prescription for a third party.
  • a third party such as a government (criminal justice entities), healthcare (payors and providers), and/or remote drug and alcohol testing services, want to be able to remotely determine if the user has ingested any illicit drug or alcohol and then be able to report any failure.
  • a frequent requirement of probation is that the former incarcerated user cannot use any illicit drug or drink alcohol during the probation.
  • a user who has been treated for an addiction may be restricted from ingested any illicit drug or alcohol during the treatment and recovery.
  • Figure 1 A is an example of a system for measurement and compliance reporting to a third party system
  • Figure IB illustrates a method for remote monitor and compliance reporting for drug and alcohol use
  • Figure 2A is an example of a system for measurement and compliance reporting to a responsible party
  • Figure 2B illustrates a method for remote monitor and compliance reporting for drug and alcohol use
  • Figure 3 is a chart showing examples of the substances that may be measured that may be used in the method to detect drug use or alcohol consumption;
  • Figures 4A and 4B illustrate a patch and its components;
  • Figure 5 illustrates an example implementation of the patch and its electronics
  • Figure 6 illustrates an example implementation of the optical biosensing module that is part of the patch
  • Figure 7 illustrates an example implementation of the optical data acquisition portion of the patch
  • Figure 8 illustrates an example implementation of the temperature sensor of the patch
  • Figure 9 illustrates an example implementation of the accelerometer of the patch.
  • Figure 10 illustrates an example implementation of the positioning system of the patch
  • Two embodiments of the remotely measures drug and alcohol use of an individual are disclosed in which one is a commercial embodiment to be used by criminal justice, courts and the like and other embodiment is a retainer embodiment to be used by a person, such as a legal guardian, who is monitoring the drug and alcohol use of a person.
  • the disclosure is particularly applicable to a system that remotely measures drug and alcohol use of an individual and reports a state of compliance of the individual to a third party and it is in this context that the disclosure will be described.
  • the system may have a path that is worn by each individual that gathers sweat of the individual, can then measure drug or alcohol use by the individual, report to a remote platform that can report the compliance of lack of compliance of the individual to an interested third party.
  • the interested third party may be a criminal justice entity, such as a probation office or probation officer, a healthcare entity, such as a payor or a provider and/or a remote testing facility. It will be appreciated, however, that the system and method has greater utility.
  • FIG. 1A is an example of an implementation of a system 100 for measurement and compliance reporting to a third party system 106 in which the third party system may be an entity that desires to remotely monitor drug or alcohol use of an individual and be notified if/when the individual violates a ban on drug use or alcohol consumption.
  • the third party may a criminal justice entity, such as a probation division that wants to enforce a ban of drug and alcohol consumption during the probation period of a former prisoner, a healthcare entity, such as a payor or provider that wants to enforce a ban of drug or alcohol use for a person being treated and recovering from an addiction or a testing company.
  • the system 100 may be used to monitor and report on a plurality of individuals, such as User A, User B, . . ., User N.
  • Each individual may have a patch 102 adhered to his/her body at any location on the body that captures a bodily fluid of the individual, such as sweat, that may be analyzed/tested for one or more substances that provide evidence that the individual is using one or more drugs or has consumed alcohol.
  • the capturing of the bodily fluid may occur continuously while the patch is adhered to the individual.
  • the analysis/testing of the sweat may occur at the patch or the path may send sweat measurement data to a back end 104 that then performs the analysis/testing, such as using the tester 104C of the backend 104. If the patch performs the analysis, then the patch may communicate the test/analysis data to the backend 104.
  • Each patch 102 may include various elements (described below in more detail, that include an attachment or adhesive element to attached to the individual, a processor that can receive the measurement data and perform the analysis, a memory to store various data and a wireless communications interface that allows each patch 102 to connect to and communicate with the backend 104.
  • each patch 102 connects to and communicates with a computing device of each individual or a central reporting computer wirelessly and then the computing device sends the data into the backend 104.
  • the wireless communication path between each badge 120 and the backend 104 may be bidirectional in that the backend may send firmware updates to each patch or a signal to check that the patch is still active.
  • the analysis of the data from the bodily fluid, whether done on the patch or the backend 1043, may be performed continuously or may be performed periodically as data from the sweat over a period of time are analyzed.
  • the backend 104 may be implemented as one or more computing resources, such as server computers, databases, blade computers or cloud computing resources, with at least one processor and a plurality of instructions that are executed by the processor to configure the processor to perform the operations and processes of the backend 104.
  • Each element of the backend 104 may alternatively be implemented in hardware.
  • the backend 104 may include a store 104A, implemented as a software or hardware database system, that stores the various data used by the system as well as data about the individuals, data about each third party and their policy and the like.
  • the backend 104 may also have an input processor 104B that receives the signals/data from each patch 102, cleans up and normalizes the data and stores it in the store 104A for the particular individual since each piece of data from each patch is identifiable by a unique identifier of the individual.
  • the input processor 104B may also include an analog to digital conversion process if needed to convert analog signals into digital signals.
  • the backend may also have a tester 104C that, if the determination of the drug use/alcohol use analysis is being performed at the backend 104, receives the data/signals from each patch and detects amounts of certain substances in the sweat data that indicate whether or not the individual has been using any drugs or consuming alcohol during a period of time.
  • the backend 104 may have a compliance module 104D that determines if the data from the individual indicates that a violation of a compliance policy of a particular third party has occurred.
  • the compliance policy for a particular third party may be retrieved from the store 104A and compared to the data generated from the patch. For example, if the third party is the state criminal justice system of Arizona, the backend may retrieve that particular compliance policy that defines the ban on drug use and alcohol use in the context of the Arizona legal definitions of drunkenness or drug use and then compare the data generated from the patch to those numbers.
  • a compliance policy may define non-compliance as two or more non-compliance events over a certain period of time for alcohol, but any non-compliance event for a drug may be sufficient to trigger the non-compliance determination.
  • the backend 104 may also have a reporting module 104E that reports a non- compliance event for an individual to the appropriate third party system 106 so that the third party system and its employees can take the appropriate action.
  • the system remotely monitors an individual’s drug or alcohol use (without any blood draw or lab testing), detects a violation of a compliance policy of a third party and reports that non- compliance to the third party.
  • Figure IB illustrates a method 150 for remote monitor and compliance reporting for drug and alcohol use that may be carried out by the system in Figure 1A, but may also be performed in other manner and using other mechanisms that are within the scope of the disclosure.
  • the method may first capture (continuously in some embodiments) the bodily of the individual using a patch (152).
  • the bodily fluid may be sweat in one embodiment.
  • the method may then measure one or more substances in the bodily fluid (154) that indicate whether or not the individual is using any particular drug or consuming alcohol.
  • substances measured to indicate drug use and a cutoff level that indicates drug use are shown in Figure 3.
  • the method remote from the patch, may then determine if a third party compliance policy was violated (156) based on the measured one or more substances.
  • the compliance policy for a particular third party may be retrieved and compared to the data generated from the patch. If the individual violated the compliance policy for the third party, the third party may be alerted (158).
  • the disclosure is particularly applicable to a system that remotely measures drug and alcohol use of a minor, child or juvenile (the user) and reports a state of compliance of the user to a legal guardian or parent (responsible party) of the user in which the patch of the system may be purchased at a retail location by the responsible party and it is in this context that the disclosure will be described.
  • the system may have a patch that is worn by each user that gathers sweat of the user and that can measure substances in the sweat of the user to determine if the user has used drugs or alcohol during a period of time and report to the responsible party the compliance or lack of compliance of the user.
  • system and method has greater utility.
  • system may be implemented with a different patch that measures the drug and/or alcohol use using a different bodily secretion instead of sweat and may be implemented using a differently architected back end platform system. All of these variations are within the scope of this disclosure.
  • Figure 2A is an example of an implementation of a system 200 for measurement and compliance reporting to a responsible party 206, such as a legal guardian or parent, in which the responsible party desires to remotely monitor drug or alcohol use of the user and be notified if/when the user violates a ban on drug use or alcohol consumption.
  • the system 200 may be used to monitor and report on a plurality of users, such as User A, User B, . . User N in which the compliance for each user is reported to the responsible party of the user.
  • the system 200 may have 100 users with the reporting to 100 different responsible parties.
  • Each user may have a patch 202 adhered to his/her body at any location on the body that captures a bodily fluid of the individual, such as sweat, that may be analyzed/tested for one or more substances that provide evidence that the individual is using one or more drugs or has consumed alcohol.
  • one or more patch(s) 202 may be purchased by each responsible party from a company that operates the system or from one or more third party retailers. The responsible party may then sign up for the compliance program (such as by signing up for a subscription of service of the system) that activates the patch to remotely monitor the user and report non-compliance of the ban of using drugs or alcohol to the responsible party.
  • the service may be a drug and alcohol use monitoring and compliance program that is activated by the sign up to activate the patch and its monitoring and reporting compliance issues to the responsible party when drug and/or alcohol use is detected by the user.
  • the capturing of the bodily fluid of the user may occur continuously while the patch 202 is adhered to the user so that the user is being monitored regardless of the physical location of the user or whether or not the user is being supervised.
  • the patch 202 as described below in more detail, may have an anti-removal/damage mechanism that prevents the user from being able to remove the patch 202 without an alert being sent to the responsible party.
  • the analysis/testing of one or more substances in the bodily fluid may occur at the patch 202 or the patch 202 may send bodily fluid measurement data to a back end computer system 204 that then performs the analysis/testing, such as using a tester element 204C of the backend 204. If the patch 202 performs the analysis, then the patch 202 may communicate the test/analysis data to the backend 204.
  • Each patch 202 may include various elements (described below in more detail, that include an attachment or adhesive element to attached to the user, a processor that can receive the measurement data and perform the analysis, a memory to store various data and a wireless communications interface that allows each patch 202 to connect to and communicate with the backend 204.
  • each patch 202 connects to and communicates with a computing device of each user or a central reporting computer wirelessly and then the computing device sends the data into the backend 204.
  • the wireless communication path between each badge 202 and the backend 204 may be bidirectional in that the backend may send firmware updates to each patch or a signal to check that the patch is still active.
  • the analysis of the data from the bodily fluid, whether done on the patch or the backend 204, may be performed continuously or may be performed periodically as data from the sweat over a period of time are analyzed.
  • the backend 204 may be implemented as one or more computing resources, such as server computers, databases, blade computers or cloud computing resources, with at least one processor and a plurality of instructions that are executed by the processor to configure the processor to perform the operations and processes of the backend 204.
  • Each element of the backend 204 may alternatively be implemented in hardware.
  • the backend 204 may include a store 204A, implemented as a software or hardware database system, that stores the various data used by the system as well as data about the individuals, data about each third party and their policy and the like.
  • the backend 204 may also have an input processor 204B that receives the signals/data from each patch 202, cleans up and normalizes the data and stores it in the store 204A for the particular user since each piece of data from each patch is identifiable by a unique identifier of the user.
  • the input processor 204B may also include an analog to digital conversion process if needed to convert analog signals into digital signals.
  • the backend may also have a tester 204C that, if the determination of the drug use/ alcohol use analysis is being performed at the backend 204, receives the data/signals from each patch and detects amounts of certain substances in the sweat data that indicate whether or not the user has been using any drugs or consuming alcohol during a period of time.
  • the backend 204 may have a compliance module 204D that determines if the data from the user indicates that a violation of a compliance policy of the responsible party for the user has occurred.
  • the compliance policy of the responsible party may be an absolute ban on drug use or alcohol consumption for a user who is under the legal age to drink, or is may be absolute ban on drug use or alcohol consumption for a user who has previously abused drugs or alcohol, etc.
  • the backend 204 may also have a reporting module 204E that reports a non- compliance event for the user to the responsible party 206 so that the responsible party can take the appropriate action.
  • the system remotely monitors the user’s drug or alcohol use (without any blood draw or lab testing), detects a violation of a compliance policy and reports a non-compliance to the responsible party.
  • Figure 2B illustrates a method 250 for remote monitor and compliance reporting for drug and alcohol use that may be carried out by the system in Figure 2A, but may also be performed in other manner and using other mechanisms that are within the scope of the disclosure.
  • the method may first capture (continuously in some embodiments) the bodily fluid of the individual using a patch (252).
  • the bodily fluid may be sweat in one embodiment.
  • the method may then measure one or more substances in the bodily fluid (254) that indicate whether or not the user is using any particular drug or consuming alcohol.
  • substances measured to indicate drug use and a cutoff level that indicates drug use are shown in Figure 3.
  • the substances for measuring alcohol user are well known and may be used to assess alcohol use.
  • the method remote from the patch, may then determine if the compliance policy was violated (256) based on the measured one or more substances.
  • the compliance policy for the responsible party may be retrieved and compared to the data generated from the patch. If the individual violated the compliance policy, the responsible party may be alerted (258).
  • the method deters the drug use or alcohol use of the user due to the constant monitoring of the user.
  • the patch as discussed below, may include a mechanism that prevents removal or modification/ disabling of the patch by the user.
  • the patch that is adhered to each user to perform the monitoring of the individual may be a flexible adhesive patch containing self-powered electronics, radio(s), and sensors.
  • the patch s main function is to monitor targeted biometric indicators in a human body and securely return collected data via a RF connection. Sensor data will include location, acceleration, heart rate, body temperature, and hydration levels. Targeted body chemistry is highly desired, and accommodations will be made in the electronics and packaging for future inclusion.
  • FIGs 4A and 4B illustrate a patch 102 and its components.
  • the path may have an adhesive portion 400 that can be adhered to the skin of the individual and may also have foil.
  • the patch may also have a housing 402 that is connected to the adhesive layer 400 and contains the electronics of the patch as described below.
  • the housing 402 may have a flexible outer layer 404, such as a thin durable, flexible synthetic membrane, and a rigid inner shell 406 wherein the flexible outer layer protects the hardware elements inside of the housing from water and other environmental factors and the inner rigid shell 406 protects the hardware elements inside of the housing from physical damage.
  • the housing 402 may have a collection layer 408 that collects the bodily fluid, such as sweat, of the individual that is wearing the patch 102. As is known, the bodily fluid is captured in a well known manner and collects in the collection layer 406.
  • the housing 402 may also have an area for a set of biometric and optical sensors 410 that houses the various biometric and optical sensors of the patch adjacent the collection area 408 and an area for a set of other electronics 412 that are described below in more detail.
  • the biosensor in Figure 6 and the optical data acquisition element in Figure 7 and temperature sensor in Figure 8 may be housed in the area 410 while the processor in Figure 5, the accelerometer in Figure 9 and the positioning receiver in Figure 10 may be housed in area 412 for the other electronics.
  • the patch may include a Power up indication, such as an LED on the device will indicate a powered status and a Pairing/ connection indication, such as an LED on the device will indicate an active, paired status.
  • the adhesive/foil layer 400 may be adhered to an initially clean and dry part of the body of the individual that generates sweat that can be captured by the patch. Once the patch is adhered to the individual, the wearer has no direct control over the features and functions of the Patch and removal of the Patch must first be authorized through the dashboard.
  • the patch may function in concert with 1) a paired proximity Bluetooth device which has a persistent connection to a Wide Area Network, or 2) a cellular network via NB-IoT.
  • a proximity Bluetooth device When connected to a proximity Bluetooth device, an application on that device can confirm the connection and data transmission in real-time.
  • a Cloud-based dashboard may confirm the connection and data transmission in real-time.
  • the above can be accomplished using the wireless RF circuits shown in Figure 5.
  • the patch may perform over-the -Air (OTA) updates to the firmware and applications residing on the Patch.
  • OTA over-the -Air
  • a device 102 firmware/software update can be queued from the Dashboard on the back end of the Cloud-based system 104 and the updates can be device-specific or broadcast to multiple units at once.
  • the OTA will automatically be received securely by the device and temporarily stored in non-volatile system memory.
  • a brief reboot of the processor is required for firmware upgrades, while an application or change in sampling rates or transmission frequency requires no reset.
  • Activation/deactivation of sensors, frequency of data collection, frequency of data transmission, and LED status indications can be modified with an OTA software update.
  • the patch 102 After it is attached to the body of the individual, the patch 102 will begin to collect and transmit data to a paired device/network. Some sensor data is dependent upon conditions which may take some time to manifest, however the sensors will attempt to collect the data from the moment of placement. Sensors within the patch will monitor device health, location, heart rate, body temperature, hydration, and targeted body chemistry (the one or more substances) on a programmable schedule (which would be controlled by the Cloud-based dashboard). A 3 -axis accelerometer will also be included. As described above, processes on the Patch, in the Cloud, or both, will look for patterns and thresholds in the acquired biometric data. Status, warnings, and alerts can be generated programmatically and used to monitor the health of the device and, more importantly, the compliance and location of the individual wearing the device.
  • the patch location data may be acquired in a few ways - either from directly acquired location coordinates or through the proximity of a paired GPS-capable device, such as a smartphone or similar device.
  • the device will include GPS*, NB- loT/Sigfox/LoRa, and BTLE 5.x.
  • GPS directly collects geostationary satellite coordinates to within five meters of accuracy.
  • NB-IoT trilaterates on the device from distant cellular towers.
  • BTLE 5.x utilizes RSSI and linear direction- finding from a BTLE 5.x capable device (the paired device or a stationary BTLE Edge gateway).
  • the location data is gathered continuously (while in range/sight of satellites, the GPS-enabled paired device, and/or cellular towers) and reported either in real-time, on a scheduled transmission, or stored and forwarded upon reconnection (when without WAN access for a period of time).
  • no data transport method i.e., no in-range paired device or cellular towers
  • the device will continue to acquire location data and store it for later transmission upon reconnection to a Wide Area Network.
  • the dashboard for each patch may log a temporary or persistent lack of data and create an alert.
  • the dashboard will monitor the health of the device, including the proper function of sensors and battery level. All incoming and outgoing data will be hardware encrypted using a 128-bit AES cypher. The data is unpacked via a key on both the device and the back-end system, ensuring the secure transport of data. Proximity detection may be a byproduct of the combination of components on the Patch.
  • BTLE has the capability of passively acknowledging nearby Bluetooth devices, and can also securely exchange information with Bluetooth devices possessing the appropriate application. Both passive and active proximity detections would be logged and passed along in the data.
  • the patch utilizes hardware features intended to detect tampering or removal of the Patch from the body, as well as monitor the health of the device. For example, a delicate series of wires or foil is woven/embedded into the adhesive layer on the underside of the flexible carrier, forming a closed circuit to be monitored for a break.
  • the adhesive-foil combination will be designed to separate when the Patch is removed. A break in this circuit would indicate tampering, removal, or a fatal manipulation of the applied Patch.
  • the device Upon detection of failure, the device would queue to transmit the failed status immediately. Unexpected sensor readings, such as those expected to be seen in open air or fluid, would also queue a failure status for transmission. An interruption in the transmission of scheduled device health status checks would also queue a failure status upon the next transmission - if any - or create an alert on the dashboard to flag a lack of incoming data (indicating a possibly non-functional device).
  • the moisture collection or subdermal monitoring at the surface of the skin requires that the area covered by the Patch will remain isolated, air-tight, and uncontaminated.
  • the patch 102 will ensure the integrity of sensor data by resisting all air, moisture, and chemicals encountering the exterior of the Patch.
  • the patch 102 may have a thickness (height) that is not more than 0.4 inches. Furthermore, the overall footprint of the patch 102 may be limited to not more than 12 in 2 . The moisture collection area at the center of the patch 102 will tend to drive the size of the Patch, yet efforts will be made to reduce the overall footprint without losing effectiveness.
  • the measurements of the body chemistry/substances can use one or more different methods including analog sensing, perspiration collection and optical sensing and/or direct subdermal monitoring.
  • Figure 5 illustrates an example implementation of the patch and its electronics including the processor, that may preferable by a commercially available ARM M3/M4 processor and the other elements of the system including the sensors, etc.
  • Figure 6 illustrates an example implementation of the optical biosensing module (using a commercially available Maxim 86146 integrated circuit in one implementation) that is part of the patch.
  • the particular IC shown in Figure 6 may be a complete optical biosensing module with ultra-low power biometric sensor hub that may be housed in the area 410 of the patch 102 as shown in Figure 4B above. This module/IC may have optimized performance to detect pulse heart rate and arterial oxygen saturation.
  • Figure 7 illustrates an example implementation of the optical data acquisition portion of the patch that may be an ultra-low power optical data acquisition system that may also be part of the area 410 in the patch.
  • this element may be a commercially available Maxim 861708 integrated circuit.
  • the element may have optimized performance to detect Optical Heart Rate, Heart Rate Variability, Oxygen Saturation (SpO2), Body Hydration, Muscle and Tissue Oxygen Saturation (Sm02 and StO2), Maximum Oxygen Consumption (VO2 max).
  • Figure 8 illustrates an example implementation of the temperature sensor of the patch.
  • the temperature sensor may be implemented using a commercially available Maxim 30208 integrated circuit and may have +/- 0.1° C accuracy.
  • Figure 9 illustrates an example implementation of the accelerometer of the patch that may be implemented using a commercially available Analog Devices ADXL355 integrated circuit.
  • Figure 10 illustrates an example implementation of the positioning system of the patch. In one embodiment, the positioning system may be a GPS receiver that is implemented using the various commercially available Maxim integrated circuits shown in Figure 10.
  • each patch 102, 202 may use an electrochemical impedance sensor with an attached binder for non-alcohol drugs of abuse. That binder will likely be either an antibody or molecularly imprinted polymer (MIP) based on an experimental test results of the Conductive Technology sensors (disclosed in Appendix A and B that form part of the specification) with both off the shelf antibodies and with MIPs from MIP Diagnostics.
  • the electrochemical impedance sensor could be utilized for various bodily fluids including sweat or interstitial fluid (ISF) depending on the design of the rest of the patch 102,202 (an example of which is disclosed in Appendix C that forms part of the specification).
  • the system and method disclosed herein may be implemented via one or more components, systems, servers, appliances, other subcomponents, or distributed between such elements.
  • such systems may include and/or involve, inter alia, components such as software modules, general-purpose CPU, RAM, etc. found in general-purpose computers,.
  • components such as software modules, general-purpose CPU, RAM, etc. found in general-purpose computers,.
  • a server may include or involve components such as CPU, RAM, etc., such as those found in general-purpose computers.
  • system and method herein may be achieved via implementations with disparate or entirely different software, hardware and/or firmware components, beyond that set forth above.
  • components e.g., software, processing components, etc.
  • computer-readable media associated with or embodying the present inventions
  • aspects of the innovations herein may be implemented consistent with numerous general purpose or special purpose computing systems or configurations.
  • exemplary computing systems, environments, and/or configurations may include, but are not limited to: software or other components within or embodied on personal computers, servers or server computing devices such as routing/connectivity components, hand-held or laptop devices, multiprocessor systems, microprocessor-based systems, set top boxes, consumer electronic devices, network PCs, other existing computer platforms, distributed computing environments that include one or more of the above systems or devices, etc.
  • aspects of the system and method may be achieved via or performed by logic and/or logic instructions including program modules, executed in association with such components or circuitry, for example.
  • program modules may include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular instructions herein.
  • the inventions may also be practiced in the context of distributed software, computer, or circuit settings where circuitry is connected via communication buses, circuitry or links. In distributed settings, control/instructions may occur from both local and remote computer storage media including memory storage devices.
  • Computer readable media can be any available media that is resident on, associable with, or can be accessed by such circuits and/or computing components.
  • Computer readable media may comprise computer storage media and communication media.
  • Computer storage media includes volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data.
  • Computer storage media includes, but is not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical storage, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and can accessed by computing component.
  • Communication media may comprise computer readable instructions, data structures, program modules and/or other components. Further, communication media may include wired media such as a wired network or direct-wired connection, however no media of any such type herein includes transitory media. Combinations of the any of the above are also included within the scope of computer readable media.
  • the terms component, module, device, etc. may refer to any type of logical or functional software elements, circuits, blocks and/or processes that may be implemented in a variety of ways.
  • the functions of various circuits and/or blocks can be combined with one another into any other number of modules.
  • Each module may even be implemented as a software program stored on a tangible memory (e.g., random access memory, read only memory, CD-ROM memory, hard disk drive, etc.) to be read by a central processing unit to implement the functions of the innovations herein.
  • the modules can comprise programming instructions transmitted to a general- purpose computer or to processing/graphics hardware via a transmission carrier wave.
  • modules can be implemented as hardware logic circuitry implementing the functions encompassed by the innovations herein.
  • modules can be implemented using special purpose instructions (SIMD instructions), field programmable logic arrays or any mix thereof which provides the desired level performance and cost.
  • SIMD instructions special purpose instructions
  • features consistent with the disclosure may be implemented via computer-hardware, software, and/or firmware.
  • the systems and methods disclosed herein may be embodied in various forms including, for example, a data processor, such as a computer that also includes a database, digital electronic circuitry, firmware, software, or in combinations of them.
  • a data processor such as a computer that also includes a database, digital electronic circuitry, firmware, software, or in combinations of them.
  • firmware firmware
  • software or in combinations of them.
  • aspects of the method and system described herein, such as the logic may also be implemented as functionality programmed into any of a variety of circuitry, including programmable logic devices (“PLDs”), such as field programmable gate arrays (“FPGAs”), programmable array logic (“PAL”) devices, electrically programmable logic and memory devices and standard cell-based devices, as well as application specific integrated circuits.
  • PLDs programmable logic devices
  • FPGAs field programmable gate arrays
  • PAL programmable array logic
  • electrically programmable logic and memory devices and standard cell-based devices as well as application specific integrated circuits.
  • Some other possibilities for implementing aspects include: memory devices, microcontrollers with memory (such as EEPROM), embedded microprocessors, firmware, software, etc.
  • aspects may be embodied in microprocessors having software-based circuit emulation, discrete logic (sequential and combinatorial), custom devices, fuzzy (neural) logic, quantum devices, and hybrids of any of the above device types.
  • the underlying device technologies may be provided in a variety of component types, e.g., metal-oxide semiconductor field-effect transistor (“MOSFET”) technologies like complementary metal-oxide semiconductor (“CMOS”), bipolar technologies like emitter-coupled logic (“ECL”), polymer technologies (e.g., silicon- conjugated polymer and metal-conjugated polymer-metal structures), mixed analog and digital, and so on.
  • MOSFET metal-oxide semiconductor field-effect transistor
  • CMOS complementary metal-oxide semiconductor
  • ECL emitter-coupled logic
  • polymer technologies e.g., silicon- conjugated polymer and metal-conjugated polymer-metal structures
  • mixed analog and digital and so on.

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Abstract

Un système et un procédé surveillent à distance l'utilisation de médicament et la consommation d'alcool d'un individu et rapportent un non-respect à une tierce partie. Dans un mode de réalisation, le système peut surveiller l'utilisation de médicament et d'alcool d'un adolescent et rapporter un non-respect d'une interdiction d'utilisation de médicament et de consommation d'alcool à un tuteur ou parent légal de l'adolescent.
PCT/US2021/053966 2020-10-07 2021-10-07 Système et procédé de de détermination de respect d'utilisation de substances illicites Ceased WO2022076681A1 (fr)

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US202063088860P 2020-10-07 2020-10-07
US63/088,860 2020-10-07
US202063111868P 2020-11-10 2020-11-10
US63/111,868 2020-11-10

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6443892B1 (en) * 2000-09-28 2002-09-03 The United States Of America As Represented By The Secretary Of The Navy Sweat collecting device and methods for use and detection of tampering
KR100528306B1 (ko) * 1997-04-11 2005-11-15 알자 코포레이션 침투성을 최소화한 검출 장치
JP2007152108A (ja) * 2005-12-02 2007-06-21 Cordis Corp 連続的生体内診断のための一体化されたセンサー配列を備えた選択的に剥き出し可能なミニチュアプローブ
US20140336487A1 (en) * 2011-09-02 2014-11-13 Joseph Wang Microneedle arrays for biosensing and drug delivery
US10543503B1 (en) * 2011-10-27 2020-01-28 Copilot Ventures Fund Iii Llc Methods of delivery of encapsulated perfluorocarbon taggants

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100528306B1 (ko) * 1997-04-11 2005-11-15 알자 코포레이션 침투성을 최소화한 검출 장치
US6443892B1 (en) * 2000-09-28 2002-09-03 The United States Of America As Represented By The Secretary Of The Navy Sweat collecting device and methods for use and detection of tampering
JP2007152108A (ja) * 2005-12-02 2007-06-21 Cordis Corp 連続的生体内診断のための一体化されたセンサー配列を備えた選択的に剥き出し可能なミニチュアプローブ
US20140336487A1 (en) * 2011-09-02 2014-11-13 Joseph Wang Microneedle arrays for biosensing and drug delivery
US10543503B1 (en) * 2011-10-27 2020-01-28 Copilot Ventures Fund Iii Llc Methods of delivery of encapsulated perfluorocarbon taggants

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