SYSTEM AND METHOD FOR USING INTEGRATED SENSOR ARRAYS TO MEASURE AND ANALYZE MULTIPLE BIOSIGNATURES IN REAL TIME
20210169357 · 2021-06-10
Assignee
Inventors
- Dalton Pont (Sterling, VA, US)
- Dan B. Tolley (Purcellville, VA, US)
- Roger A. Mann (Herndon, VA, US)
- Joseph Tolley (Purcellville, VA, US)
- John V. Chiochetti (Annapolis, MD, US)
Cpc classification
Y02A90/10
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
A61B5/1113
HUMAN NECESSITIES
A61B5/14546
HUMAN NECESSITIES
A61B5/02055
HUMAN NECESSITIES
A61B5/322
HUMAN NECESSITIES
A61B5/14532
HUMAN NECESSITIES
A61B5/02438
HUMAN NECESSITIES
G16H10/40
PHYSICS
A61B5/002
HUMAN NECESSITIES
International classification
A61B10/00
HUMAN NECESSITIES
A61B5/00
HUMAN NECESSITIES
A61B5/0205
HUMAN NECESSITIES
A61B5/11
HUMAN NECESSITIES
A61B5/145
HUMAN NECESSITIES
A61B5/1455
HUMAN NECESSITIES
A61B5/322
HUMAN NECESSITIES
Abstract
Systems and methods including a device having integrated sensor arrays constructed and configured to measure and analyze multiple biosignatures concurrently in real time and a mobile application to control the device, process data, and transmit data wirelessly via at least one network to at least one remote computing device for analyzing the multiple biosignatures and cross-correlation with at least one external factor resulting in the creation of personal and situation profiles for continued on-going real time monitoring, refinement, alerting, and action recommendations.
Claims
1. A system for using integrated sensor arrays to measure and analyze multiple biosignatures from a human or an animal comprising: an apparatus for sensing and analyzing at least two biosignatures, wherein the apparatus includes a biosensor array, an electronic core, and at least one antenna; at least one remote transceiver device; and at least one remote computer server; wherein the biosensor array comprises at least two sensors; wherein one or more of the at least two sensors includes at least one sympathetic nervous system (SNS) sensor and at least one non-sympathetic nervous system (non-SNS) sensor; wherein the at least one SNS sensor is used to calibrate one or more of the at least one non-SNS sensor; wherein the apparatus analyzes at least two biosignatures from the at least two sensors, calculates at least one output datum of the at least two biosignatures, and transmits the at least one output datum to the at least one remote transceiver device; wherein the at least one remote transceiver device transmits the at least one output datum to the at least one remote computer server or at least one remote computing device or database for storage; wherein the apparatus and the at least one remote transceiver device have real-time or near-real-time two-way communication; wherein the at least one remote transceiver device and the at least one remote computer server have real-time or near-real-time communication; and wherein the at least one remote computer server is operable to analyze apparatus data.
2. The system of claim 1, wherein the apparatus is integrated into a wearable device, wherein the wearable device includes a sleeve or a wrist band.
3. The system of claim 1, wherein the at least one remote computer server is operable to analyze the apparatus data using cross-modal analytics, wherein the cross-modal analytics include change detection, rates, vectors, cross queues, tips, condition settings, user settings, self-calibrations, personalization, trends, patterns, validations, and/or alerts, wherein the at least one remote computer server is configured to generate an automatic alert based on the cross-modal analytics, wherein the automatic alert is transmitted to an emergency response service.
4. The system of claim 1, wherein the at least one remote computer server is operable to store apparatus data, wherein the at least one remote computer server is operable to create a personal profile for the human or the animal based on the stored apparatus data, wherein the at least one remote computer server is further operable to create an alert threshold based on the personal profile, wherein the at least one remote computer server is operable to adjust the personal profile and the alert threshold based on new apparatus data.
5. The system of claim 1, wherein the at least one remote computer server is operable to create a personal profile for the human or the animal using cross-modal analytics, wherein the cross-modal analytics is configured to monitor changes in the at least two biosignatures, wherein the personal profile is based on change rates, change vectors, change trends, and/or change patterns determined using the cross-modal analytics.
6. The system of claim 1, wherein the at least one SNS sensor includes at least one electromagnetic sensor, wherein the electromagnetic sensor is configured to detect the presence of at least one designated disease based on a magnetic charge.
7. The system of claim 1, wherein the apparatus further includes at least one environmental sensor, wherein the at least one environmental sensor includes a temperature sensor, an air sensor, and/or a sound sensor.
8. The system of claim 1, wherein the electronic core comprises a multiplexer, at least one analog-to-digital converter, and at least one processor.
9. The system of claim 1, wherein the electronic core includes at least one light emitting diode (LED), wherein the LED is configured to provide at least one alert based on the analyzed apparatus data, wherein the at least one alert indicates the human or the animal is at risk of undergoing an adverse event.
10. The system of claim 1, wherein the remote computer server is configured to generate and store a personal profile for a plurality of humans or a plurality of animals based on apparatus data, wherein the remote computer server is further configured to monitor and compare the personal profile for at least two of the plurality of humans or at least two of the plurality of animals.
11. The system of claim 1, further including an artificial intelligence engine, wherein the at least one remote computer server is configured to analyze the apparatus data using cross-modal analytics, wherein the artificial intelligence engine is configured to determine at least one trend and/or at least one pattern based on the analyzed apparatus data.
12. A system for using integrated sensor arrays to measure and analyze multiple biosignatures from a human or an animal comprising: an apparatus for sensing and analyzing at least two biosignatures, wherein the apparatus includes a biosensor array, an electronic core, and at least one antenna; at least one remote transceiver device; and at least one remote computer server; wherein the biosensor array comprises at least two sensors; wherein one or more of the at least two sensors includes at least one sympathetic nervous system (SNS) sensor and at least one non-sympathetic nervous system (non-SNS) sensor; wherein the at least one SNS sensor is used to calibrate one or more of the at least one non-SNS sensor; wherein the apparatus analyzes at least two biosignatures from the at least two sensors, calculates at least one output datum of the at least two biosignatures, and transmits the at least one output datum to the at least one remote transceiver device; wherein the at least one remote transceiver device transmits the at least one output datum to the at least one remote computer server or at least one remote computing device or database for storage; wherein the apparatus and the at least one remote transceiver device have real-time or near-real-time two-way communication; wherein the at least one remote transceiver device and the at least one remote computer server have real-time or near-real-time communication; wherein the at least one remote computer server is operable to analyze apparatus data; wherein the at least one remote computer server is operable to detect at least one biosignature change and at least one rate of change of the at least one biosignature change; wherein the at least one remote computer server is configured to receive at least one designated threshold for at least one biosignature of the at least two biosignatures; and wherein the at least one remote computer server is operable to generate at least one alert when the at least one biosignature change and the at least one rate of change of the at least one biosignature is greater than the at least one designated threshold.
13. The system of claim 12, wherein the at least one remote computer server is operable to analyze the apparatus data using cross-modal analytics, wherein the cross-modal analytics include change detection, rates, vectors, cross queues, tips, condition settings, user settings, self-calibrations, personalization, trends, patterns, validations, and/or alerts.
14. The system of claim 12, wherein the at least one remote computer server includes at least one external factor, wherein the at least one external factor is at least one clinical observation, eyewitness data, offline analytics, at least one laboratory test result, weather data, social media analytics, third party data, external research, and/or web data.
15. The system of claim 12, wherein the real-time or near-real-time two-way communication further comprises commands, electrode calibration, software updates, new or updated algorithms, new or updated modifying variables for algorithms, processor health properties, error codes, and/or electrode maintenance or malfunction.
16. A system using integrated sensor arrays to measure and analyze at least one biosignature from a human or an animal comprising: an apparatus including a biosensor array, at least two sensors, at least one analog-to-digital converter, a multiplexer, a processor, and at least one antenna; at least one remote transceiver device; and at least one remote computer server; wherein the at least two sensors include at least one sympathetic nervous system (SNS) sensor and at least one non-sympathetic nervous system (non-SNS) sensor, wherein the sympathetic nervous system sensor is configured to calibrate the at least one non-SNS sensor; wherein the at least one remote transceiver device and the apparatus are operable for two-way cross-communication in real time or near-real time; wherein each of the at least two sensors are configured to capture at least one biosignature of the human or the animal; wherein the processor is configured to convert the at least one biosignature of the human or the animal into at least one output datum using at least one algorithm; wherein one or more of the at least one antenna is configured to transmit the at least one output datum to the at least one remote transceiver device via the two-way communication with the apparatus; wherein the at least one remote transceiver device is configured to share and/or transmit the at least one output datum with at least one remote computer server or at least one remote computing device or database for storage; and wherein the at least one remote computer server is configured to analyze apparatus data.
17. The apparatus of claim 16, wherein two or more of the at least two sensors are of differing modalities, wherein the differing modalities include imaging, photon, spectroscopy, electrochemical, inertial, thermal, radiofrequency, electromagnetic, and/or ultrasound.
18. The apparatus of claim 16, further including at least one external factor, wherein the at least one external factor includes clinical observations, eyewitness data, offline analytics, laboratory test results, weather, social media analytics, and web data, wherein the at least one remote computer server is operable to analyze the apparatus data using cross-modal analytics, wherein the cross-modal analytics is configured to compare the at least one external factor to the apparatus data.
19. The apparatus of claim 16, wherein the at least one remote computer server is operable to analyze the apparatus data using cross-modal analytics, wherein the cross-modal analytics include change detection, rates, vectors, cross queues, tips, condition settings, user settings, self-calibrations, personalization, trends, patterns, validations, and/or alerts.
20. The apparatus of claim 16, further including an artificial intelligence engine, wherein the at least one remote computer server is configured to analyze the apparatus data using cross-modal analytics, wherein the artificial intelligence is configured to determine at least one trend and/or at least one pattern based on the analyzed apparatus data.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0064] The present invention is generally directed to systems and methods including a device having integrated sensor arrays constructed and configured to measure and analyze inputs from sensors that provide multiple biosignatures in real time. The system includes a mobile application to control, process, and transmit data. The systems and methods are operable to transmit the inputs and/or data wirelessly via at least one communications network to a remote computing device for analyzing the multiple biosignatures, calculating data related to the multiple biosignatures, and storing the data in a database, on the remote computing device, and/or a remote computer server or cloud-based computing system.
[0065] In one embodiment, the present invention provides a system for using integrated sensor arrays to measure and analyze multiple biosignatures from a human or an animal including an apparatus for sensing and analyzing at least two biosignatures, wherein the apparatus includes a biosensor array, an electronic core, and at least one antenna, at least one remote transceiver device, and at least one remote computer server, wherein the biosensor array includes at least two sensors, wherein two or more of the at least two sensors are of differing modalities, wherein the electronic core includes a multiplexer, at least one analog-to-digital converter, and at least one processor, wherein the apparatus analyzes at least two biosignatures from the at least two sensors, calculates at least one output datum of the at least two biosignatures, and transmits the at least one output datum to the at least one remote transceiver device, wherein the at least one remote transceiver device transmits the at least one output datum to the at least one remote computer server or at least one remote computing device or database for storage, wherein the apparatus and the at least one remote transceiver device have real-time or near-real-time two-way communication, wherein the at least one remote transceiver device and the at least one remote computer server have real-time or near-real-time communication, and wherein the at least one remote computer server is operable to analyze apparatus data using cross-modal analytics.
[0066] In another embodiment, the present invention provides a system for using integrated sensor arrays to measure and analyze multiple biosignatures from a human or an animal including an apparatus for sensing and analyzing at least two biosignatures, wherein the apparatus includes a biosensor array, an electronic core, and at least one antenna, at least one remote transceiver device, and at least one remote computer server, wherein the biosensor array includes at least two sensors, wherein two or more of the at least two sensors are of differing modalities, wherein the electronic core includes a multiplexer, at least one analog-to-digital converter, and at least one processor, wherein the apparatus analyzes at least two biosignatures from the at least two sensors, calculates at least one output datum of the at least two biosignatures, and transmits the at least one output datum to the at least one remote transceiver device, wherein the at least one remote transceiver device transmits the at least one output datum to the at least one remote computer server or at least one remote computing device or database for storage, wherein the apparatus and the at least one remote transceiver device have real-time or near-real-time two-way communication, wherein the at least one remote transceiver device and the at least one remote computer server have real-time or near-real-time communication, wherein at least one external factor is stored on the at least one remote computer server, wherein the at least one remote computer server is operable to analyze apparatus data using cross-modal analytics, wherein the at least one remote computer server is operable to detect at least one biosignature change and at least one rate of change of the at least one biosignature change, wherein the at least one remote computer server is operable to generate at least one alert when the at least one biosignature change and the at least one rate of change of the at least one biosignature is greater than a designated threshold.
[0067] In yet another embodiment, the present invention includes a method for using integrated sensor arrays to measure and analyze multiple biosignatures from a human or an animal, the method including providing an apparatus for sensing and analyzing at least two biosignatures, wherein the apparatus includes at least two sensors, at least one analog-to-digital converter, a multiplexer, a processor, and at least one antenna, at least one remote transceiver device, and at least one remote computer server, wherein the at least one remote transceiver device and the apparatus are operable for two-way cross-communication in real time or near-real time, each of the at least two sensors sensing at least one biosignature of the human or the animal, the processor converting the at least one biosignature of the human or the animal into at least one output datum using at least one algorithm, one or more of the at least one antenna transmitting the at least one output datum to the at least one remote transceiver device via the two-way communication with the apparatus, the at least one remote transceiver device sharing or transmitting the at least one datum with the at least one remote computer server or at least one remote computing device or database for storage, and the at least one remote computer server analyzing apparatus data using cross-modal analytics.
[0068] Referring now to the drawings in general, the illustrations are for the purpose of describing a preferred embodiment of the invention and are not intended to limit the invention thereto.
[0069] Prior art sensors, as shown in
[0070] In other prior art cases, a circuit is designed to handle multiple sensors of a single type/modality (e.g., electrochemical sensors to analyze different analytes in sweat). In both prior art cases, the circuit is fine-tuned for a single modality and all signals are processed independently and analyzed independently. Data is stored, viewed, and/or displayed as separate biosensor data. None of the prior art includes multi-modal analytics. The prior art uses multiple devices to access the data using many independent applications for each single modality. This results in unconnected user functions and users are limited to results from a single modality.
[0071] Examples of prior art sensors include the following issued patents and/or publications for biological fluid sensors: U.S. Pat. Nos. 9,579,024, 9,622,725, 9,636,061, 9,645,133, and 9,883,827 and U.S. Publication Nos. 20160262667, 20160287148, and 20170223844, each of which is incorporated herein by reference in its entirety.
[0072] The present invention uses multiple sensors, modalities, and/or targets through a single circuit, in a single device, with cross-modal (X-Mod) analytics.
[0073] In a preferred embodiment, the device 200 is controlled and configured (e.g., sample rate, sample frequency, sample instructions, processing instructions) via at least one remote transceiver device 230 (e.g., smartphone, tablet, laptop computer, desktop computer) with a user interface. The user interface is preferably a mobile application. The at least one remote transceiver device 230 is operable to process the data and send the data to an aggregated data cloud 240. The aggregated data cloud 240 is operable to further process the data and provide analytics. In one embodiment, the data is aggregated into a single cloud for linear modal processing of each modality. In another embodiment, the single cloud uses X-Mod analytics, which are cross-modal analytics that include change detection, rates, vectors, cross queues, tips, condition settings, user settings, self-calibrations, trends, patterns, validations, and/or alerts. Performance of the at least two sensors 202 is improved through active integration of the at least two sensors 202 into an array that is then processed, analyzed, stored, and accessed through a single system consisting of a measurement circuit, a mobile application, and a cloud database. The single circuit is designed for multiple sensors, signals, and sensitivities across many modalities. The single circuit isolates many different signals, filters noise, and mitigates interference across the modalities on the single circuit with highly complex firmware to handle each sensor read, sample rate, data scheme, storage, and other similar control commands. The aggregated data cloud 240 includes external factors 250, such as clinical observations, eyewitness data, offline analytics, laboratory test results, weather, social media analytics, external research, and web data. The analytics draw across all modalities and external information in the cloud 240.
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[0076] In another embodiment, the electronic core includes at least one memory. In one embodiment, the at least one memory is RAM, ROM, EPROM, EEPROM, and/or FLASH memory. In another embodiment, one or more of the at least one memory is incorporated into the at least one processor. In yet another embodiment, one or more of the at least one memory is operable to store raw data obtained by the device and/or at least one output datum calculated by the device.
[0077] In another embodiment, the electronic core includes at least one light emitting diode (LED). In one embodiment, the at least one LED is a tri-color LED. In one example, the tri-color LED is a red, green, and blue (RGB) LED. Advantageously, the RGB LED allows for color mixing, which allows for a greater number of colors from a single LED. One or more of the at least one LED is preferably operable to provide alerts based on analyzed data. In one example, an LED begins flashing (e.g., red flashing) when the analyzed data indicates that a user may experience an adverse event (e.g., heart attack) in the near future. In yet another embodiment, one or more of the at least one LED is operable to provide an indication of battery status. In one example, an LED begins flashing (e.g., white flashing) when the battery needs to be charged. In still another embodiment, one or more of the at least one LED is operable to provide an indication of the at least one memory status. In one example, an LED begins flashing (e.g., yellow flashing) when the at least one memory is almost full. This prompts the user to visit a scanner to refresh the at least one memory.
[0078] The device includes a sweat sensor, at least one temperature sensor, a pH sensor, a heart rate sensor, a blood oxygen sensor (e.g., a pulse oximetry sensor), an accelerometer, a glucose sensor, and/or at least one sympathetic nervous system (stress) sensor. In one embodiment, the sweat sensor measures a concentration of sodium in sweat and a concentration of potassium in sweat. The device is preferably operable to measure a concentration ratio of sodium to potassium, which provides an estimate of fluid losses (e.g., through sweat). The at least one temperature sensor is operable to measure skin temperature, core temperature, and/or ambient temperature. The accelerometer is operable to measure impact, shivering, seizures, and/or any other similar body movements. The blood oxygen sensor measures peripheral capillary oxygen saturation (SpO2). In one embodiment, the blood oxygen sensor is used in combination with an accelerometer measuring respiratory rates to produce sweat loss estimates using X-Mod analytics, which calibrates and/or validates prior readings from the sodium sensor and/or the potassium sensor. The at least one sympathetic nervous system (SNS) sensor is operable to measure cardio stress, pulmonary blood oxygen stress, physical stress, gastro stress, thermoregulation stress, glucose stress, arterial stress, and/or acid stress. In a preferred embodiment, the SNS sensor is non-invasive and uses at least one electrocardiogram (ECG) pad. In one embodiment, the SNS sensor is used to calibrate and/or validate other sensors. In a preferred embodiment, the glucose sensor is non-invasive and measures RF changes in the skin. The stabilized antibodies sensors detect the presence of designated antigens and other signs of bacterial and/or viral infections. In a preferred embodiment, viral sensors and/or bacterial sensors utilize antibodies stabilized through ionic fluid. This extends the shelf life of the viral sensors and/or the bacterial sensors under ambient/non-cooled storage conditions. The antibodies are used to detect antigens for designated infections using immunoassays and/or redox cells. In one embodiment, the assay results are presented as a binary true or false reading. A positive result indicating the presence of a target antigen is preferably represented visually (e.g., a color change to blue). Alternatively, the presence of a target antigen is indicated through voltage changes in a redox cell. In one embodiment, infection detection is further validated with detection signals from at least one electromagnetic sensor on the device. The at least one electromagnetic sensor is operable to detect at least one designated infection in the blood that carries a magnetic charge. In another embodiment, the device includes an analyte sensor to detect an analyte (e.g., hormones, electrolytes, small molecules (molecular weight <900 Daltons), proteins, metabolites). The device also includes modular communications (e.g., NEAR FIELD COMMUNICATION (NFC), BLUETOOTH, WI-FI, ZIGBEE).
[0079] As previously described, the at least one SNS sensor preferably uses at least one ECG pad. The at least one ECG pad is placed on a wrist, an upper arm, a chest, a back, a finger, a neck, or other designated location on a user. The at least one SNS sensor detects and processes sympathetic nerve system activity (SNSA). In one embodiment, changes in SNSA are correlated with known conditions, data from at least one other sensor, and external factors (e.g., clinical observations). The system is operable to distinguish between cardio stress, pulmonary blood oxygen stress, physical stress, gastro stress, thermoregulation stress, glucose stress, arterial stress, and/or acid stress via signal characterization (e.g., signal gain rate, signal amplitude shape, signal decline, signal phase shifts).
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[0082] The device is operable to be charged using proximity charging with a wrist band pad. In a preferred embodiment, the proximity charging utilizes far-field technology that converts radio frequency (RF) energy into direct current (DC) power. In another embodiment, the wrist band includes a removeable power cable to recharge via an alternating current (AC) source.
[0083] In another embodiment, the device includes at least one medical textile. In one example, the device includes a top layer formed of a medical textile (e.g., 3M™ 9926T Tan Tricot Fabric Medical Tape), a bottom layer formed of a double-sided adhesive (e.g., 3M™ 9917 Medical Nonwoven Tape), and an electronic core positioned between the top layer and the bottom layer. The top layer formed of the medical textile includes an adhesive layer that is attached to a top side of the electronic core. The bottom layer formed of the double-sided adhesive is attached on a first side to a bottom side of the electronic core and intimately adhered on a second side to the skin of the wearer. In another example, the device includes a top layer formed of a medical textile (e.g., 3M™ 9926T Tan Tricot Fabric Medical Tape), a bottom layer formed of the medical textile (e.g., 3M™ 9926T Tan Tricot Fabric Medical Tape), and an electronic core positioned between the top layer and the bottom layer. The top layer formed of the medical textile includes an adhesive layer that is attached to a top side of the electronic core and the bottom layer formed of the medical textile includes an adhesive layer that is attached to a bottom side of the electronic core. In one embodiment, the top layer and/or the bottom layer includes at least one opening for a sensor, an LED, and/or other electronic components. In yet another embodiment, the device includes a transceiver antenna flap with a top layer formed of a medical textile (e.g., 3M™ 9926T Tan Tricot Fabric Medical Tape), a bottom layer formed of the medical textile (e.g., 3M™ 9926T Tan Tricot Fabric Medical Tape), and a transceiver antenna coil between the top layer and the bottom layer. Advantageously, this provides additional protection to the transceiver antenna coil. In one embodiment, the device is secured to the wearer using hook and loop tape, at least one magnetic closure, at least one snap, at least one clasp, at least one tie, at least one hole, at least one tab, at least one cord lock, and/or at least one buckle.
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[0085] The wearable forearm sleeve 500 is operable to be charged using proximity charging with a sleeve recharging cone 520. In a preferred embodiment, the proximity charging utilizes far-field technology that converts radio frequency (RF) energy into direct current (DC) power. In one embodiment, the sleeve recharging cone 520 includes charging tabs 522 for contact charging as an alternative to proximity charging.
[0086] As previously described, the device includes a biosensor array. The device has a single multiplexer that pulls in signals from all of the sensors and all of the modalities. The signals flow through a series of capacitors and resistors to properly condition the signals, which are then converted using an ADC with a programmable amplifier. The amplifier gain is customized to reach designated thresholds for each sensor signal type, without over gain. The ADC signals are passed to the microprocessor for processing and converting, and then to storage in one or more of the at least one memory. The microprocessor manages read times, gains, processing, and store instructions. Data in storage is extracted via a communications event (e.g., NFC scan, BLUETOOTH read, burst).
[0087] A first source of data is the biosensor array, which is operable to sense multiple targets (e.g., sweat, urine, blood, skin, air, sound) using multiple modalities (e.g., imaging, spectroscopy, electrochemical, thermal). The integrated sensor array uses one circuit to measure, process, and store data. The circuit is designed for multiple sensors, signals, and sensitivities across many modalities. The single circuit isolates many different signals, filters noise, and mitigates interference across the modalities on the single circuit with highly complex firmware. A second source of data is external information, such as clinical observations, eyewitness data, offline analytics, laboratory test results, and web data. The data is aggregated into a single data cloud for linear modal processing of each modality. Cross modal analytics (X-Mod) include cross queues, tips, condition settings, user settings, self-calibrations, personalization, trends, patterns, validation of the data, and/or alerts based on the data. This results in a personal profile and situation profiles that are monitored and compared to an existing profile for a user and common demographic populations or other groups of common interest and/or attributes. Examples of groups of common interest and/or attributes include, but are not limited to, pregnancy, maternal delivery, cancer detection, cancer treatment, drug therapies, military special operations, emergency service personnel (e.g., fire, rescue, police), and athletes (e.g., race car drivers, football players, marathon runners).
[0088] One example of personalization is adjusting a blood pressure range based on patient history and/or conditions. For example, a blood pressure of 144/95 mmHg is deemed normal for a patient when the patient's blood sugar is under 200 mg/dL and an alert condition is set when the systolic blood pressure is above 150 when the patient's blood sugar is above 225 mg/dL. Advantageously, the personal profile is operable to adjust a baseline and at least one alert threshold, which prevents the system from needlessly alerting health and/or aid workers for conditions normal for a particular patient.
[0089] In a preferred embodiment, a mobile application on at least one remote transceiver device provides visibility to raw data and/or X-Mod analytics. The mobile application preferably is operable to provide an alert, a notification, and/or an acknowledgement. In one embodiment, the mobile application is operable to forward an alert, a notification, and/or an acknowledgement to another user. In one example, an alert regarding a patient is sent to a healthcare provider or a caregiver. In another example, a patient sends an acknowledgement after a healthcare provider makes a modification to a protocol (e.g., modification of insulin dosage, timing of medication). The mobile application preferably aligns information from the ISA with advisor prescribed information to recommend an action to a user.
[0090] In one embodiment, the mobile application provides a record and/or a timestamp for when a user completes an action (e.g., takes a medication). Additionally, or alternatively, the mobile application allows a user to mark an action as complete. In another embodiment, the mobile application allows a user to mark an action as delayed. The mobile application preferably resends a notification to remind the user to complete the delayed action.
[0091] In one embodiment, the mobile application includes at least one scheduled advisory action (e.g., dietary, exercise, medication) for a patient. A medication scheduled advisory action includes a name of a prescription, a dosage of the prescription (e.g., volume, weight), a prescription number, a production identification, and/or a picture reminder. In a preferred embodiment, the mobile application coordinates re-ordering consumables (e.g., medication, bandages). The mobile application preferably checks for potential drug interactions. In another embodiment, the mobile application advises a user of expectations and/or possible side effects based on a medication prescribed and/or a location. The mobile application interacts with healthcare providers (e.g., doctors, nurses, in-home health care), caregivers, hospice, and/or emergency services (e.g., paramedics, police, fire, first responders). In one embodiment, the mobile application is operable to be programmed for areas of concern, special medical treatment, and/or allergies. In another embodiment, the mobile application is operable to follow an escalation process of communication and alerts defined by a user and/or an advisor (e.g., healthcare provider).
[0092] In one embodiment, the mobile application records a time and a unit related to food (e.g., type, weight, calories, macros) and/or drink (e.g., by volume) consumed. The mobile application preferably records a physical activity of the user. In one embodiment, the physical activity of the user is measured by the accelerometer. In another embodiment, the mobile application records environmental parameters (e.g., temperature, humidity) of a location of the user.
[0093] In one embodiment, more than one mobile application is used to provide additional layers of security. In one example, a user has access to all health data of the user through a first mobile application, while the health data is inaccessible to a worker employed to read or scan sensor outputs through a second mobile application. Alternatively, the mobile application provides several account types. In one example, the mobile application includes a user (e.g., patient) account type, an employee (e.g., scanner) account type, a humanitarian (e.g., Red Cross) account type, and a healthcare provider (e.g., doctor, nurse) account type. In another example, authentication and/or encryption is used to provide for select user or restricted access to the health data of the individual.
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[0095] In the example shown in
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[0098] As previously described, the present invention utilizes X-Mod schemes to improve accuracy via multi-source calibration and validation. X-Mod analytics use changes in multiple sensor streams and create profiles based on change rates, change vectors, change trends, and/or change patterns. A collection of changes that represent a normal day for an individual is called a personal profile. Similarly, a set of changes that characterize a unique situation for a group and/or demographic of a population all under a similar situation (e.g., pregnancy, cancer, concussion) is called a situation profile. Personal profiles and situation profiles are compared to real time biosignature change activity in a user to detect anomalies, concerns, and/or general items of interest.
[0099]
[0100] For the cross-modal (X-Mod) analysis, the following algorithm is used to determine a change in biosignature (dBioSig):
dBioSig=dS1+dS2+dS3+ . . . +dSn
[0101] where dS is a biosensor change over a period of time (T). The biosensor change over the period of time (dS) is a function of a magnitude/scaling factor (m), sensor dependent variables (dSV), and time dependent variables (dTV).
[0102] One example of a change in biosignature is shown in the following equation:
[0103] where dHR is a change in heart rate over a period of time, dO2 is a change in blood oxygen level over the period of time, dAccel is a change in acceleration over the period of time, dTemp is a change in body temperature over the period of time, and dSLR is a change in sodium loss rate over the period of time.
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[0105] The X-Mod analytics are transmitted to an artificial intelligence (AI) engine to analyze the X-Mod analytics as shown in
[0106]
[0107] However, calibrating a signal to determine sweat (fluid) loss is difficult because a human body is very adaptable to stress. When stressed by ambient temperature, humidity, and other similar factors, sodium secretion into sweat is conserved, resulting in a much higher sweat rate (fluid loss) at a given sodium concentration in order to accelerate cooling. Additionally, variations in conditioning level (VO.sub.2 max) further complicate the calibration, and introduce additional variability into the results. Consequently, external factors (e.g., heat, humidity) and conditioning induced stress will cause the sweat/sodium relationship curve to shift, meaning sodium is conserved so sweat volume actually increases with lower sodium concentration. This results in an incorrect original signal calibration. Many factors influence human sweat rate, which is a dynamic human body phenomenon that is difficult to model through software alone.
[0108] One method of measuring human physiological stress is by monitoring the human sympathetic nervous system (SNS). Sympathetic nervous system activity (SNSA) signals control physiological response to stress (fight or flight response), including the thermal regulation system (sweat glands). As a result, SNS signals are an ideal means to better calibrate an ISE sweat sensor signal as shown in the graph in
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[0120] In one embodiment, the device is an ear sensor. In one example, the ear sensor includes a heart rate sensor, a blood oxygen sensor, a blood pressure sensor, at least one temperature sensor (e.g., skin temperature, core temperature, ambient temperature), and/or a motion sensor (e.g., accelerometer). In another embodiment, the device is a patch. In one example, the patch includes a sweat sensor to monitor at least one analyte (e.g., sodium, potassium, cortisol), at least one temperature sensor (e.g., skin temperature, core temperature, ambient temperature), and/or a motion sensor (e.g., accelerometer).
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[0128] A diagram of the system communications is shown in
[0129] The at least one remote transceiver device and the sensor apparatus are operable for two-way cross-communication in real time or near real time. The at least one remote transceiver device is operable to communicate with the sensor apparatus to provide, by way of example and not limitation, commands, electrode calibration, software updates, new or updated algorithms, and/or new or updated modifying variables for algorithms. The sensor apparatus is operable to communicate with the at least one remote transceiver device to provide, by way of example and not limitation, output data, processor health properties (e.g., microcontroller health properties), error codes, electrode maintenance, or malfunction. In a preferred embodiment, the remote transceiver device is operable to allow at least one user to view data from at least one sensor apparatus, including sensor history, output data, and biosignature data for an individual. Additionally, or alternatively, the remote transceiver device is operable to allow at least one user to view data from a plurality of sensor apparatuses, including output data, biosignature data, and overall population trends.
[0130] The at least one remote transceiver device and the cloud and/or the at least one remote computer server are operable for two-way cross-communication in real time or near real time. In one embodiment, the cloud and/or the at least one remote computer server is operable to transmit the commands, the electrode calibration, the software updates, the new or updated algorithms, the new or updated modifying variables for algorithms to the at least one remote transceiver device. In another embodiment, the cloud and/or the at least one remote computer server is operable to provide software updates for the at least one remote transceiver device (e.g., updates to the mobile application). The data from the sensor apparatus is augmented by additional information and/or external factors. In one embodiment, the additional information and/or the external factors are stored in the cloud and/or on the at least one remote computer server. For example, the additional information and/or external factors include results of laboratory tests, clinical observations, offline analytics, eyewitness data, web data, and third party web services (e.g., weather, World Health Organization (WHO) and International Organization for Migration (IOM) alerts). Additionally, social media use can be monitored to supplement the data from the sensor apparatus. In a preferred embodiment, the additional information and/or the external factors are processed with the data from the sensor apparatus in the cloud and/or on the at least one remote computer server.
[0131]
[0132] A diagram of the system architecture is shown in
[0133] From the cloud computing system, data including X-Mod results from multiple users may be stored, as diagrammed in
[0134] Additionally, the ability to collect biosignature data from a large population of subjects provides physicians with a method of monitoring a specific population and/or performing triage. For example, the sensor apparatus can be placed on victims of a disaster, allowing physicians to monitor victims and attend to the most critically injured victims first. The sensor apparatus can also be used to monitor prisoners for health issues and/or fighting. Alternatively, the sensor apparatus can be used to monitor alcoholics or drug addicts for relapse.
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[0136] The server 850 is constructed, configured, and coupled to enable communication over a network 810 with a plurality of computing devices 820, 830, 840. The server 850 includes a processing unit 851 with an operating system 852. The operating system 852 enables the server 850 to communicate through network 810 with the remote, distributed user devices. Database 870 may house an operating system 872, memory 874, and programs 876.
[0137] In one embodiment of the invention, the system 800 includes a cloud-based network 810 for distributed communication via a wireless communication antenna 812 and processing by at least one mobile communication computing device 830. Alternatively, wireless and wired communication and connectivity between devices and components described herein include wireless network communication such as WI-FI, WORLDWIDE INTEROPERABILITY FOR MICROWAVE ACCESS (WIMAX), Radio Frequency (RF) communication including RF identification (RFID), NEAR FIELD COMMUNICATION (NFC), BLUETOOTH including BLUETOOTH LOW ENERGY (BLE), ZIGBEE, Infrared (IR) communication, cellular communication, satellite communication, Universal Serial Bus (USB), Ethernet communications, communication via fiber-optic cables, coaxial cables, twisted pair cables, and/or any other type of wireless or wired communication. In another embodiment of the invention, the system 800 is a virtualized computing system capable of executing any or all aspects of software and/or application components presented herein on the computing devices 820, 830, 840. In certain aspects, the computer system 800 may be implemented using hardware or a combination of software and hardware, either in a dedicated computing device, or integrated into another entity, or distributed across multiple entities or computing devices.
[0138] By way of example, and not limitation, the computing devices 820, 830, 840 are intended to represent various forms of digital computers 820, 840, 850 and mobile devices 830, such as a server, blade server, mainframe, mobile phone, personal digital assistant (PDA), smartphone, desktop computer, netbook computer, tablet computer, workstation, laptop, and other similar computing devices. The components shown here, their connections and relationships, and their functions, are meant to be exemplary only, and are not meant to limit implementations of the invention described and/or claimed in this document
[0139] In one embodiment, the computing device 820 includes components such as a processor 860, a system memory 862 having a random access memory (RAM) 864 and a read-only memory (ROM) 866, and a system bus 868 that couples the memory 862 to the processor 860. In another embodiment, the computing device 830 may additionally include components such as a storage device 890 for storing the operating system 892 and one or more application programs 894, a network interface unit 896, and/or an input/output controller 898. Each of the components may be coupled to each other through at least one bus 868. The input/output controller 898 may receive and process input from, or provide output to, a number of other devices 899, including, but not limited to, alphanumeric input devices, mice, electronic styluses, display units, touch screens, signal generation devices (e.g., speakers), or printers.
[0140] By way of example, and not limitation, the processor 860 may be a general-purpose microprocessor (e.g., a central processing unit (CPU)), a graphics processing unit (GPU), a microcontroller, a Digital Signal Processor (DSP), an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA), a Programmable Logic Device (PLD), a controller, a state machine, gated or transistor logic, discrete hardware components, or any other suitable entity or combinations thereof that can perform calculations, process instructions for execution, and/or other manipulations of information.
[0141] In another implementation, shown as 840 in
[0142] Also, multiple computing devices may be connected, with each device providing portions of the necessary operations (e.g., a server bank, a group of blade servers, or a multi-processor system). Alternatively, some steps or methods may be performed by circuitry that is specific to a given function.
[0143] According to various embodiments, the computer system 800 may operate in a networked environment using logical connections to local and/or remote computing devices 820, 830, 840, 850 through a network 810. A computing device 830 may connect to a network 810 through a network interface unit 896 connected to a bus 868. Computing devices may communicate communication media through wired networks, direct-wired connections or wirelessly, such as acoustic, RF, or infrared, through an antenna 897 in communication with the network antenna 812 and the network interface unit 896, which may include digital signal processing circuitry when necessary. The network interface unit 896 may provide for communications under various modes or protocols.
[0144] In one or more exemplary aspects, the instructions may be implemented in hardware, software, firmware, or any combinations thereof. A computer readable medium may provide volatile or non-volatile storage for one or more sets of instructions, such as operating systems, data structures, program modules, applications, or other data embodying any one or more of the methodologies or functions described herein. The computer readable medium may include the memory 862, the processor 860, and/or the storage media 890 and may be a single medium or multiple media (e.g., a centralized or distributed computer system) that store the one or more sets of instructions 900. Non-transitory computer readable media includes all computer readable media, with the sole exception being a transitory, propagating signal per se. The instructions 900 may further be transmitted or received over the network 810 via the network interface unit 896 as communication media, which may include a modulated data signal such as a carrier wave or other transport mechanism and includes any delivery media. The term “modulated data signal” means a signal that has one or more of its characteristics changed or set in a manner as to encode information in the signal.
[0145] Storage devices 890 and memory 862 include, but are not limited to, volatile and non-volatile media such as cache, RAM, ROM, EPROM, EEPROM, FLASH memory, or other solid state memory technology; discs (e.g., digital versatile discs (DVD), HD-DVD, BLU-RAY, compact disc (CD), or CD-ROM) or other optical storage; magnetic cassettes, magnetic tape, magnetic disk storage, floppy disks, or other magnetic storage devices; or any other medium that can be used to store the computer readable instructions and which can be accessed by the computer system 800.
[0146] It is also contemplated that the computer system 800 may not include all of the components shown in
[0147] The above-mentioned examples are provided to serve the purpose of clarifying the aspects of the invention, and it will be apparent to one skilled in the art that they do not serve to limit the scope of the invention. By way of example, the glucose sensor can measure glucose levels in blood, interstitial fluid, or sweat using a disposable patch. Sweat sensors can analyze various biomarkers, including glucose, calcium, ammonium, amino acids, hormones, steroids, proteins, and interleukins. The above-mentioned examples are just some of the many configurations that the mentioned components can take on. All modifications and improvements have been deleted herein for the sake of conciseness and readability but are properly within the scope of the present invention.