SWEAT SENSING DEVICE COMMUNICATION SECURITY AND COMPLIANCE

• US 20170215773A1
• Filed: 04/14/2017
• Published: 08/03/2017
• Est. Priority Date: 10/15/2014
• Status: Abandoned Application

• Current Assignee: Eccrine Systems Inc.
• Original Assignee: Eccrine Systems Inc.
• Inventors: Beech, Robert, Begtrup, Gavi, Heikenfeld, Jason, Amfahr, Jeff
• Application Number:
  US15/487,465
• Publication Number:
  US 20170215773A1
• Time in Patent Office: 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 method of monitoring whether a sweat sensing device contacts a wearer'"'"'s skin adequately to allow the device to operate, comprising:

using the sweat sensing device to take at least one skin contact reading;

comparing the at least one reading to a threshold value indicating adequate contact with skin; and

generating an alert message communicating whether skin contact is adequate for operation.

2. The method of claim 1 in which the at least one skin contact reading is chosen from the following:

a skin impedance sensor measurement; and

a capacitive sensor measurement.

3. (canceled)

4. A method of determining whether a sweat sensing device is operating on a wearer'"'"'s skin, comprising:

taking at least one measurement of at least one sweat analyte; and

using the at least one measurement to determine if the device is operating on the skin.

5. A method of determining whether a sweat sensing device wearer is a target individual, comprising:

measuring at least one of the following metrics on the device wearer;

sweat analyte data;

body composition, skin type, positive correlation of device identification number, communication strength between sweat sensing device and a computer network, sweat sensing device location, reader device location, the wearer'"'"'s electro-physical response, and concentration of a tracer molecule administered to the individual;

comparing the at least one metric with known information about the target individual to calculate an identification probability estimate; and

determining if the estimate adequately correlates the wearer with the target individual.

6. The method of claim 5 where the identification probability estimate is calculated using data from at least one of the following sensors:

accelerometer, gait analysis sensor, heart rate monitor, galvanic skin response, and pulse oximetry.

7. The method of claim 5 where the identification probability estimate is a combined probability of at least two independent identification probability estimates.

8. The method of claim 5 where an identification metric is the application of the sweat sensing device onto the target individual under supervision of a device user.

9. The method of claim 5 where the identification probability estimate is calculated using aggregated sweat sensor data that is correlated with relevant data external to the sweat sensor device.

10. A method of using data to improve the capabilities of a sweat sensing device, comprising:

obtaining and recording sensor readings from the device;

gathering information from sources external to the device;

correlating the sensor readings with the external information; and

comparing the correlated readings to previously-aggregated sensor data.

11. A method of determining whether a sweat sensing device should send a safety and health alert message, comprising:

using the device to take at least one reading;

calculating a threshold value indicating a message should be sent, where the threshold value is calculated using data from at least one of the following sensors;

ion-selective electrode sensor;

sweat analyte sensor;

skin impedance sensor;

skin capacitance sensor;

accelerometer;

gait analysis sensor;

heart rate monitor;

galvanic skin response sensor; and

pulse oximetry sensor;

comparing the at least one reading to the threshold value; and

generating an alert message if said at least one reading indicates an alert message should be sent.

13. The method of claim 11 where the threshold value is calculated using aggregated sweat sensor data correlated with relevant data external to the sweat sensor device.

12. (canceled)

14. A method of monitoring a clinical trial participant with a sweat sensing device, comprising:

configuring the device to take at least one measurement of a sweat analyte relevant to the participant'"'"'s safety;

configuring the device to take at least one measurement of a sweat analyte relevant to the participant'"'"'s compliance with at least one drug regimen;

calculating a safety profile for the wearer;

calculating at least one drug regimen compliance profile;

comparing said at least one safety measurement to said safety profile;

comparing said at least one compliance measurement to the at least one compliance profile; and

generating an alert message if said at least one safety measurement or said at least one compliance measurement indicates a message should be sent.

15. The method of claim 14 where the participant is administered a tracer compound.

16. The method claim of 14 where the profile values are calculated using aggregated sweat sensor data correlated with relevant data external to the sweat sensor device.

17. A method of monitoring a wearer'"'"'s exposure to at least one toxin with a sweat sensing device, comprising:

configuring the device to take at least one measurement of a sweat analyte associated with at least one toxin;

calculating a toxin safety profile for the wearer;

comparing the at least one analyte measurement to the safety profile; and

generating an alert message if the at least one measurement indicates exposure to the at least one toxin.

18. The method claim of 17 where the safety profile is calculated using the wearer'"'"'s history of toxin exposure.

19. The method claim of 17 where the profile values are calculated using aggregated sweat sensor data correlated with relevant data external to the sweat sensor device.

20. A sweat sensing device capable of determining whether the device is in adequate contact with, and operating on, the skin of a wearer, comprising:

a sweat sensor to provide at least one measurement of sweat;

computation, communication, and data storage means; and

a skin contact detector.

21. The device of claim 20 where the skin contact detector is one of the following:

a plurality of electrical impedance sensing electrodes; and

a plurality of capacitive sensor electrodes.

23. The device of claim 20 where the at least one sensor measurement is reported to a computer network.

24. The device of claim 23 where the communication strength between the sweat sensing device and the network can be determined and reported.

25. The device of claim 23 where the location of the device can be determined using at least one of the following means:

network access location;

or global positioning satellite.

26. The device of claim 20 where the communication means is a separate device.

27. The device of claim 20 where the device is assigned an identification code.

28. The device of claim 20 where the device generates and reports an alert message communicating whether the device is in adequate contact with the wearer'"'"'s skin.

29. The device of claim 20 where the device generates and reports an alert message communicating whether the device is operating on the wearer'"'"'s skin.

30. The device of claim 20 where the device generates and reports an alert message communicating whether a device wearer is the target individual.

31. The device of claim 20 where the device generates and reports an alert message communicating whether the at least one sensor measurement indicates that the wearer has a health condition.

32. The device of claim 20 where the device uses aggregated sweat sensor data correlated with relevant data external to the sweat sensor device to enhance the device'"'"'s ability to predict future health or performance conditions of the wearer.

34. The device of claim 20 where the at least one sensor measurement is used with aggregated sweat sensor data that is correlated with relevant data external to the sweat sensor device to construct a data set correlated with the individual within a probability range.

35. The device of claim 34 where the external information is comprised of data from at least one of the following sensors:

accelerometer, gait analysis sensor, heart rate monitor, galvanic skin response, and pulse oximetry.

36. The device of claim 34 where the data set is comprised of at least one of the following metrics:

a first sweat analyte concentration;

a ratio between the first analyte concentration and a second sweat analyte concentration;

a ratio among a plurality of sweat analyte concentrations;

a sweat analyte concentration trend; and

a sweat analyte ratio trend.

37. The device of claim 34 where the data set is comprised of data from at least one of the following sensors:

accelerometer, gait analysis sensor, heart rate monitor, galvanic skin response, and pulse oximetry.

38. The device of claim 34 where the data set is comprised of at least one of the following metrics:

body composition;

skin type; and

electro-physical response to a given stimulus.

39. The device of claim 36 where the sweat analyte is at least one of the following:

electrolyte;

nucleotide;

RNA;

micro RNA;

DNA;

hormone;

steroid;

oligomer; and

protein.

40. The device of claim 20 where the sweat measurement is of at least one of the following analytes:

electrolyte;

nucleotide;

RNA;

micro RNA;

DNA;

hormone;

steroid;

oligomer; and

protein.

22. (canceled)

33. (canceled)