Sweat sensing device communication security and compliance

• US 10,258,262 B2
• Filed: 11/28/2016
• Issued: 04/16/2019
• Est. Priority Date: 10/15/2014
• Status: Active Grant

• Current Assignee: University of Cincinnati
• Original Assignee: University of Cincinnati
• Inventors: Heikenfeld, Jason, Rose, Daniel P., Papautsky, Ian, Kang, Wenjing, Wang, Xiao, Ratterman, Michael
• Primary Examiner(s): Weare, Meredith
• Application Number:
  US15/362,303
• Publication Number:
  US 20170100072A1
• Time in Patent Office: 869 Days
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2562/0214 Capacitive electrodes
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/0533 Measuring galvanic skin response
• CPC Class Codes: A61B 5/112 Gait analysis
• CPC Class Codes: A61B 5/117 Identification of persons methods or arrangements for recognising patterns, e.g. fingerprints, G06F18/00, G06V40/00; identification of persons by analysing their voice or speech G10L17/00
• CPC Class Codes: A61B 5/14517 for sweat
• CPC Class Codes: A61B 5/14521 using means for promoting sweat production, e.g. heating the skin measuring sweat secretion A61B5/4266
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/4266 sweat secretion
• CPC Class Codes: A61B 5/4833 : Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4845 : Toxicology, e.g. by detection of alcohol, drug or toxic products A61B5/4848 takes precedence
• CPC Class Codes: A61B 5/6802 : Sensor mounted on worn items
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/6843 : Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/7275 : Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 : Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 5/7475 : User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: B05D 1/30 : performed by gravity only, i.e. flow coating
• CPC Class Codes: B05D 3/007 : After-treatment
• CPC Class Codes: B32B 2535/00 : Medical equipment, e.g. bandage, prostheses or catheter
• CPC Class Codes: B32B 37/12 : characterised by using adhesives
• CPC Class Codes: G06F 18/2415 : based on parametric or probabilistic models, e.g. based on likelihood ratio or false acceptance rate versus a false rejection rate
• CPC Class Codes: G06F 18/256 : of results relating to different input data, e.g. multimodal recognition
• CPC Class Codes: G06F 2218/12 : Classification; Matching
• CPC Class Codes: G06N 5/04 : Inference or reasoning models
• CPC Class Codes: G06V 40/15 : Biometric patterns based on physiological signals, e.g. heartbeat, blood flow
• CPC Class Codes: G06V 40/70 : Multimodal biometrics, e.g. combining information from different biometric modalities
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: H04L 67/52 : specially adapted for the location of the user terminal
• CPC Class Codes: H04Q 2209/40 : using a wireless architecture
• CPC Class Codes: H04Q 9/00 : Arrangements in telecontrol or telemetry systems for selectively calling a substation from a main station, in which substation desired apparatus is selected for applying a control signal thereto or for obtaining measured values therefrom
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10T 29/49155 : Manufacturing circuit on or in base

Abstract

The invention addresses confounding difficulties involving continuous sweat analyte measurement. Specifically, the present invention provides: at least one component capable of monitoring whether a sweat sensing device is in sufficient contact with a wearer'"'"'s skin to allow proper device operation; at least one component capable of monitoring whether the device is operating on a wearer'"'"'s skin; at least one means of determining whether the device wearer is a target individual within a probability range; at least one component capable of generating and communicating alert messages to the device user(s) related to: wearer safety, wearer physiological condition, compliance with a requirement to wear a device, device operation; compliance with a behavior requirement, or other purposes that may be derived from sweat sensor data; and the ability to utilize aggregated sweat sensor data that may be correlated with information external to the device to enhance the predictive capabilities of the device.

Claims

1. A device comprising:

a sensor apparatus for sensing and analyzing at least one fluid, wherein the sensor apparatus includes;

a first layer;

an electronic layer comprising a microcontroller, a transceiver antenna coil, and at least one sensor, wherein the at least one sensor includes at least one electrode, wherein the electronic layer is adhered to the first layer; and

a microfluidic layer adhered to the first layer, wherein the microfluidic layer is positioned on a same plane as the electronic layer and surrounds the at least one sensor of the electronic layer;

wherein the first layer is operable to allow a fluid to flow through the first layer and to the at least one sensor;

wherein the at least one electrode of the at least one sensor is operable to generate at least one measurement characterizing a biomarker present in the fluid; and

wherein the sensor apparatus uses the at least one measurement to calculate at least one output associated with the biomarker of the fluid.

2. The device of claim 1, wherein the first layer comprises double-sided adhesive adapted to be removably adhered to mammalian skin.

3. The device of claim 1, wherein the at least one sensor is an electrochemical sensor.

4. The device of claim 1, wherein:

a top layer is placed on and completely covers the electronic layer;

the top layer is vapor porous; and

the top layer is adhered to the first layer.

5. The device of claim 1, wherein the sensor apparatus is flexible.

6. The device of claim 1, wherein the fluid is sweat.

7. The device of claim 1, wherein the at least one sensor of the electronic layer is an electrochemical sensor that is operable to detect and continuously analyze the biomarker of the fluid.

8. The device of claim 7, wherein the biomarker of the fluid includes electrolytes, small molecules, and/or metabolites.

9. The device of claim 1, wherein the device wirelessly transmits the at least one output via multiple protocols in real-time to a computing device with software operable thereon for receiving, storing, and analyzing the at least one output.

10. The device of claim 9, wherein the computing device is configured to receive a second output associated with a second biomarker of the fluid, wherein the computing device is configured to calculate a concentration of each of the biomarker and the second biomarker in the at least one fluid and a comparative ratio of the biomarker to the second biomarker, and wherein the computing device provides visual representations of the concentration of the biomarker, the concentration of the second biomarker, and the comparative ratio on a graphical user interface of the computing device.

11. A device comprising:

a sensor apparatus for sensing and analyzing at least one fluid, wherein the sensor apparatus includes;

an adhesive layer including at least one pore;

an electronic layer including at least one electrochemical sensor, a microcontroller, and a transceiver antenna coil, wherein the electronic layer is positioned over the adhesive layer; and

a microfluidic layer positioned on a same plane as the electronic layer and surrounding the at least one electrochemical sensor of the electronic layer;

wherein the adhesive layer is operable to allow the fluid to flow through the at least one pore and to the at least one electrochemical sensor;

wherein the at least one electrochemical sensor is operable to generate at least one measurement characterizing an analyte present in the fluid; and

wherein the sensor apparatus uses the at least one measurement to calculate at least one output associated with the analyte of the fluid.

12. The device of claim 11, further comprising,

a top layer, wherein the top layer comprises a textile, and wherein the top layer facilitates evaporation of the fluid.

13. The device of claim 11, wherein the fluid is sweat.

14. The device of claim 11, wherein the microcontroller is operable to receive input data from at least one portable device.

15. The device of claim 14, wherein the input data received by the microcontroller comprises information about one or multiple users including weight, gender, fitness or conditioning level, and/or age.

16. The device of claim 11, wherein the at least one electrochemical sensor is operable to measure characteristics of the analyte including a concentration of the analyte relative to another analyte.

17. A device comprising:

a sensor apparatus for sensing and analyzing sweat, wherein the sensor apparatus includes;

an adhesive layer, wherein a surface of the adhesive layer is configured to be adhered to skin;

an electronic layer including at least one electrochemical sensor, a microcontroller, and transceiver antenna coil, the electronic layer being adhered to the adhesive layer; and

a microfluidic layer adhered to the adhesive layer, wherein the microfluidic layer is positioned on a same plane as the electronic layer and surrounds the at least one electrochemical sensor of the electronic layer;

wherein the adhesive layer is operable to allow sweat to flow through the adhesive layer and to the at least one electrochemical sensor;

wherein at least one electrochemical sensor is configured to generate at least one measurement characterizing a biomarker present in the sweat; and

wherein the sensor apparatus uses the at least one measurement to calculate at least one output associated with the biomarker of the sweat.

18. The device of claim 17, wherein the at least one electrochemical sensor is further operable to measure characteristics of the biomarker including a concentration of the biomarker relative to another biomarker.

19. The device of claim 17, wherein the microcontroller is operable to receive input data from at least one portable device.