Sweat sensing device communication security and compliance

• US 10,201,279 B2
• Filed: 11/28/2016
• Issued: 02/12/2019
• 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): Nguyen, Donghai D
• Application Number:
  US15/362,299
• Publication Number:
  US 20170100071A1
• Time in Patent Office: 806 Days
• Field of Search: 29830-832, 29840, 29841, 29846, 600346, 600347, 600362, 600573, 7386472, 604 20
• 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 method of fabricating a fluid sensor, comprising:

fabricating a substrate;

fabricating an electronic circuit on the substrate;

placing electronic components onto the electronic circuit by solder reflow;

fabricating at least one sensor, wherein the at least one sensor includes at least one electrode, and wherein the at least one sensor is configured to be connected to the electronic circuit;

fabricating a membrane on the at least one electrode, wherein fabricating the membrane further comprises applying an ionophore polymer coating on the at least one electrode; and

fabricating a dressing;

wherein the step of fabricating the dressing further comprises;

laser cutting a top layer medical textile;

laser cutting a microfluidic layer;

circumferentially surrounding the at least one electrode with the microfluidic layer;

laser cutting an adhesive layer; and

pressing the top layer medical textile, the microfluidic layer, the electronic circuit, and the adhesive layer for bonding.

2. The method of claim 1, wherein the at least one sensor comprises at least one electrochemical sensor and wherein the fluid sensor comprises at least:

a microcontroller and a transceiver.

3. The method of claim 2, wherein the fluid sensor includes an electrode and a reference electrode.

4. The method of claim 3, wherein the at least one electrode includes silver, copper, platinum, or a combination thereof.

5. The method of claim 1, wherein the sensor is configured to analyze a biological fluid.

6. The method of claim 5, wherein the biological fluid is sweat.

7. The method of claim 5, wherein the fluid sensor continuously monitors at least one fluid biomarker of the biological fluid.

8. The method of claim 7, wherein the at least one fluid biomarker includes small molecules, metabolites, or electrolytes.

9. A method of fabricating a biofluid sensor, comprising:

fabricating a substrate;

fabricating an electronic circuit on the substrate;

placing electronic components onto the electronic circuit by solder reflow;

fabricating at least one sensor, wherein the sensor comprises at least one active electrode configured to analyze a biological fluid and at least one reference electrode, and wherein the at least one sensor is configured to be connected to the electronic circuit;

fabricating an ionophore polymer membrane;

applying the ionophore polymer membrane on the at least one active electrode; and

fabricating a dressing;

wherein the step of fabricating the dressing further comprises;

laser cutting a top layer medical textile;

laser cutting a microfluidic layer;

circumferentially surrounding the at least one active electrode and the at least one reference electrode with the microfluidic layer;

laser cutting an adhesive layer; and

pressing the top layer medical textile, the microfluidic layer, the electronic circuit, and the adhesive layer for bonding.

10. The method of claim 9, wherein the at least one sensor comprises at least one electrochemical sensor and wherein the biofluid sensor comprises at least:

a microcontroller and a transceiver.

11. The method of claim 9, wherein the biological fluid is sweat.

12. The method of claim 11, wherein the biofluid sensor is configured to measure sweat flow rate.

13. The method of claim 9, wherein the at least one active electrode includes silver, platinum, palladium, or combinations thereof.

14. The method of claim 9, wherein the at least one active electrode is cured after applying the ionophore polymer membrane on the at least one active electrode.

15. A method of fabricating a biological fluid sensor, comprising:

fabricating a substrate;

fabricating an electronic circuit on the substrate;

placing electronic components onto the electronic circuit;

reflow soldering the electronic circuit;

fabricating a sensor configured for analyzing a biological fluid, wherein the sensor comprises at least one electrode, and wherein the sensor is configured to be connected to the electronic circuit;

fabricating an ionophore polymer membrane;

fabricating a dressing;

wherein the step of fabricating the at least one electrodes further comprises;

constructing the at least one electrode by applying a metallization paste on top of at least one first trace metal;

wherein the step of fabricating the ionophore polymer membrane further comprises applying the ionophore polymer membrane on the at least one electrode; and

wherein the step of fabricating the dressing further comprises;

laser cutting a top layer medical textile;

laser cutting a microfluidic layer;

circumferentially surrounding the at least one electrode with the microfluidic layer;

laser cutting an adhesive layer; and

pressing the top layer medical textile, the microfluidic layer, the electronic circuit, and the adhesive layer for bonding.

16. The method of claim 15, wherein the sensor comprises at least one electrochemical sensor and wherein the biological fluid sensor comprises at least:

a microcontroller, and a transceiver.

17. The method of claim 16, wherein the biological fluid sensor continuously monitors at least one fluid biomarker of the biological fluid.

18. The method of claim 17, wherein the at least one fluid biomarker includes small molecules, metabolites, or electrolytes.

19. The method of claim 15, wherein the at least one electrode is cured after applying the ionophore polymer membrane on the at least one electrode.