Sweat sensing device communication security and compliance

• US 9,867,539 B2
• Filed: 11/28/2016
• Issued: 01/16/2018
• Est. Priority Date: 10/15/2014
• Status: Expired due to Fees

• Current Assignee: University of Cincinnati
• Original Assignee: Eccrine Systems Inc.
• Inventors: Heikenfeld, Jason, Rose, Daniel P., Papautsky, Ian, Kang, Wenjing, Wang, Xiao, Ratterman, Michael
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): MESSERSMITH, ERIC J
• Application Number:
  US15/362,229
• Publication Number:
  US 20170100035A1
• Time in Patent Office: 414 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, catheter medical patches B32B2556/00
• 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 system comprising:

a first device;

a second device; and

an apparatus for sensing and analyzing at least one fluid, wherein the apparatus includes an electronic layer comprising at least one sensor

wherein the apparatus analyzes at least one biomarker of the fluid, calculates at least one output of the at least one fluid biomarker using at least one algorithm, and transmits the at least one output to the first device;

wherein the first device transmits the at least one output to the second device; and

wherein the apparatus further includes;

a double-sided adhesive layer;

a microfluidic layer; and

a vapor porous, top layer;

wherein the electronic layer is adhered to the double-sided adhesive layer;

wherein the microfluidic layer is positioned on the same side of double-sided adhesive layer as the electronic layer;

wherein the microfluidic layer and the electronic layer are substantially equidistant from the double-sided adhesive layer;

wherein the vapor porous, top layer is placed on and completely covers the microfluidic layer and the electronic layer; and

wherein the vapor porous, top layer is adhered to the double-sided adhesive layer.

2. The system of claim 1, wherein the apparatus and the first device have real-time or near-real-time two-way communication.

3. The system of claim 1, wherein the second device comprises:

a computer server, a computing device, a database, or a combination thereof.

4. The system of claim 1, wherein the apparatus is flexible.

5. The system of claim 1, wherein the apparatus is configured to be adhered to mammalian skin.

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

7. The system of claim 1, wherein the at least one biomarker of the fluid includes small molecules, metabolites, and/or electrolytes.

8. The system of claim 1, wherein the apparatus further includes a microcontroller and a transceiver antenna coil;

and

wherein the at least one sensor is an electrochemical sensor.

9. The system of claim 8, wherein the at least one sensor houses electrodes;

and

wherein electrodes comprise silver, copper, platinum, or a combination thereof.

10. The system of claim 1, wherein the apparatus wirelessly transmits the at least one output to the first device.

11. The system of claim 1, wherein the apparatus continuously monitors the at least one biomarker of the fluid.

12. A system comprising:

an apparatus for sensing and analyzing sweat, wherein the apparatus includes an electronic layer comprising at least one sensor;

a first device; and

a second device;

wherein the apparatus continuously analyzes at least one sweat biomarker in real-time, calculates at least one output of the at least one sweat biomarker using at least one algorithm, and transmits the at least one output to the first device;

wherein the first device transmits the at least one output to the second device; and

wherein the at least one sensor has at least one reference electrode and at least one active electrode;

wherein the at least one active electrode has an ionophore polymer coating;

wherein the apparatus further includes;

a double-sided adhesive layer;

microfluidic layer; and

a vapor porous, top layer;

wherein the electronic layer is adhered to the double-sided adhesive layer;

wherein the microfluidic layer is positioned on the same side of double-sided adhesive layer as the electronic layer;

wherein the microfluidic layer and the electronic layer are substantially equidistant from the double-sided adhesive layer;

wherein the vapor porous, top layer is placed on and completely covers the microfluidic layer and the electronic layer; and

wherein the vapor porous, top layer is adhered to the double-sided adhesive layer.

13. The system of claim 12, wherein the second device comprises:

a computer server, a computing device, a database, or a combination thereof;

wherein the apparatus further comprises a microcontroller and a transceiver antenna coil; and

wherein the at least one sensor is an electrochemical sensor.

14. A method comprising:

providing an apparatus for sensing and analyzing at least one fluid, wherein the apparatus includes an electronic layer comprising at least one sensor;

sensing, by the at least one sensor, at least one biomarker of the fluid;

converting, by the apparatus, the at least one biomarker of the fluid into at least one output;

transmitting, by the apparatus, the at least one output to a first device; and

transmitting, by the first device, the at least one output to a second device; and

wherein the apparatus further includes;

a double-sided adhesive layer;

microfluidic layer; and

a vapor porous, top layer;

wherein the electronic layer is adhered to the double-sided adhesive layer;

wherein the microfluidic layer is positioned on the same side of double-sided adhesive layer as the electronic layer;

wherein the microfluidic layer and the electronic layer are substantially equidistant from the double-sided adhesive layer;

wherein the vapor porous, top layer is placed on and completely covers the microfluidic layer and the electronic layer; and

wherein the vapor porous, top layer is adhered to the double-sided adhesive layer.

15. The method of claim 14, wherein the apparatus is flexible.

16. The method of claim 14, wherein the double-sided adhesive layer is configured to be adhered to mammalian skin.

17. The method of claim 14, wherein the electronic layer further comprises a microcontroller and a transceiver;

and

wherein the at least one sensor is an electrochemical sensor.

18. The method of claim 17, wherein the apparatus generates a voltage in response to sensing the at least one biomarker;

and

wherein the microcontroller generates the at least one output by passing the generated voltage as input to an algorithm.

19. The method of claim 17, wherein the at least one output is transmitted from the apparatus to the first device through wireless network communication by the transceiver of the apparatus;

and

wherein the wireless network communication is via Bluetooth, radiofrequency, or near field communication.

20. The method of claim 14, wherein the at least one output includes concentrations and descriptive statistics;

and

wherein descriptive statistics includes ratios and/or trends.