Sweat electrolyte loss monitoring devices

• US 10,736,565 B2
• Filed: 10/16/2017
• Issued: 08/11/2020
• Est. Priority Date: 10/14/2016
• Status: Active Grant

• Current Assignee: Epicore Biosystems, Inc.
• Original Assignee: Eccrine Systems Inc.
• Inventors: Begtrup, Gavi, Morgan, Austin, Larson, Mikel, Bertrand, Jacob A., Bailey, Nicholas, Newland, Cory, Beech, Robert, Hanley, Brian
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US15/754,141
• Publication Number:
  US 20190008448A1
• Time in Patent Office: 1,030 Days
• Field of Search: 600300-301
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/0533 Measuring galvanic skin response
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14517 for sweat
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/4266 sweat secretion
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/4872 Body fat
• CPC Class Codes: A61B 5/4875 Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/6801 specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61B 5/7475 : User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: G01N 33/48707 : by electrical means G01N33/49, G01N33/493 take precedence
• CPC Class Codes: G01N 33/48792 : Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C

Abstract

Embodiments of the disclosed invention provide devices and methods to incorporate suspension-based, i.e., hydrogel-based and thixotropic compound-based, ion-selective electrodes and reference electrodes into a wearable sweat sensing device. Embodiments of this device are configured to monitor sweat electrolyte concentrations, trends, and ratios under demanding use conditions. The accompanying method includes use of the disclosed device to track fluid and electrolyte gain and loss in order to produce an electrolyte estimate, such as a sweat electrolyte concentration, a sweat electrolyte concentration trend, a sweat rate, or a concentration ratio between a plurality of electrolytes.

Claims

1. A sweat sensing device configured to be worn on a skin surface of an individual, comprising:

a first layer, comprising one or more ion selective electrode (ISE) sensors for measuring a concentration of an ion in a sweat sample, the one or more ISE sensors located in a sensor channel, the sensor channel comprising an inlet and an outlet, wherein the inlet is in fluidic communication with the skin surface, and the one or more ISE sensors are located between the inlet and the outlet; and

a second layer, comprising a water impermeable substrate and a reference electrode, the reference electrode comprising;

a reference chamber containing a mixture that includes a fumed silica matrix and a reference salt, and including a fill port at a first end of the reference chamber,

a salt bridge chamber located at a second end of the reference chamber, the salt bridge chamber containing a mixture that includes a fumed silica matrix and a bridge salt, and including an exchange port configured to fluidically connect the reference electrode to the one or more ISE sensors, wherein the exchange port connects to the sensor channel at a location between the inlet and the one or more ISE sensors, and

a wire electrode extending into the reference chamber from the fill port.

2. The device of claim 1, wherein the one or more ISEs are comprised of ionophore polymers that are screen-printed on electrodes and placed on a substrate.

3. The device of claim 1, wherein the one or more ISE sensors includes an electrode, a suspension material containing a target analyte salt, an ion-selective material, an ion-exchange port, and an ion-exchange membrane;

and wherein the electrode is in fluidic communication with the suspension material, the suspension material is in fluidic communication with the ion-selective material, the ion-selective material is in fluidic communication with the ion-exchange membrane, and the ion-exchange membrane is in fluidic communication with the ion-exchange port.

4. The device of claim 3, wherein the suspension material is one of the following:

a hydrogel; and

a thixotropic compound.

5. The device of claim 1, where wherein the one or more ion selective electrode sensors are capable of measuring a concentration of one or more of the following:

Na₊;

Cl₋

;

H₊;

K₊;

NH₄₊;

Ca⁺;

HCO₃₋

; and

Mg₊.

6. The device of claim 1, further comprising a secondary sensor chosen from the following:

a volumetric sweat rate sensor;

a micro-thermal sweat flow rate sensor;

a sweat conductivity sensor; and

a skin temperature sensor.

7. The device of claim 1, wherein the reference salt is one of the following:

KCl.

8. The device of claim 1, wherein the bridge salt is one of the following:

MgSO₄, and MgCl₂.

9. The device of claim 3, wherein the target analyte salt is one of the following:

NaCl, KCl, and MgCl₂.

10. The device of claim 1, wherein the exchange port further includes a reference membrane comprising one of the following:

a dialysis membrane;

an osmotic membrane;

a track-etch membrane;

a multi-phase membrane;

a zwitterionic polymer membrane;

an ion exchange resin membrane; and

a tunable membrane.

11. A method of using the device of claim 1 to monitor an individual'"'"'s electrolyte levels, the method comprising:

receiving one or more measurements of a concentration of an ion in a sweat sample with an ion selective electrode (ISE) sensor;

receiving input relevant to one or more of the following;

a hydration status for the individual;

an electrolyte status for the individual;

a fluid intake for the individual;

a fluid output for the individual;

an electrolyte intake for the individual; and

an electrolyte output for the individual;

using said measurements and said input to develop one or more of the following electrolyte values;

a sweat electrolyte concentration;

a sweat electrolyte concentration trend;

a sweat rate; and

a concentration ratio between a plurality of electrolytes; and

outputting information derived from the one or more electrolyte values.

12. The method of claim 11, further comprising comparing the electrolyte value to a baseline value, where said baseline value reflects one of the following:

a profile for the individual;

a profile for one or more persons with similar relevant characteristics to the individual; and

external information.

13. The method of claim 12, wherein said baseline value is derived from one of the following:

a skin temperature for the individual;

a sweat rate for the individual;

a heart rate for the individual;

an age of the individual;

a sex of the individual;

an initial hydration state for the individual;

a body mass index of the individual;

a transdermal evaporative fluid loss for the individual;

a kidney health of the individual;

a fitness level for the individual;

a heat acclimation level for the individual;

a recent physical activity level for the individual;

relevant characteristics of another person or persons;

altitude;

air temperature; and

humidity.

14. The method of claim 11, further comprising developing the electrolyte value using one of the following:

a sweat rate measurement;

a sweat conductivity measurement;

a sweat onset time;

a sweat cessation time;

a sweat rate change time;

a sweat conductivity change time; and

a skin temperature change time.

15. The method of claim 11, wherein said information is one of the following:

the electrolyte value;

a recommendation to consume an amount of fluid; and

a recommendation to consume an amount of electrolyte.