DEVICE FOR MEASURING BIOLOGICAL FLUIDS

• US 20160287148A1
• Filed: 06/09/2016
• Published: 10/06/2016
• Est. Priority Date: 03/09/2015
• Status: Abandoned Application

• Current Assignee: CoreSyte, Inc.
• Original Assignee: CoreSyte, Inc.
• Inventors: Pizer, Adam, Nyberg, Sten Adam, Pont, Dalton
• Application Number:
  US15/177,667
• Publication Number:
  US 20160287148A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 10/00 Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis vaccination prophylaxis, vaccination therapy A61B17/20; Sex determination; Ovulation-period determination menstruation tables G06C3/00; Throat striking implements
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2010/0087 Breath samples
• CPC Class Codes: A61B 2503/10 Athletes
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/0257 using atmospheric pressure
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/14517 for sweat
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• 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 5/4266 sweat secretion
• CPC Class Codes: A61B 5/443 Evaluating skin constituents, e.g. elastin, melanin, water
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick

Abstract

A flexible, multi-layered device for automatically sensing sweat biomarkers, storing and transmitting sensed data via wireless network to a computing device having software applications operable thereon for receiving and analyzing the sensed data. The device is functional in extreme conditions, including extremely hot temperatures, extremely cold temperatures, high salinity, high altitude, extreme pHs, and/or extreme pressures.

Claims

1. A device for analyzing biological fluid from a human and transmitting and storing biological fluid data from the human, wherein the device is for extended wear by a human under demanding conditions, comprising:

a fluid sensor apparatus for sensing and analyzing at least one biological fluid, wherein the fluid sensor apparatus is multi-layered, including;

a macrofluidic, double-sided adhesive layer;

an electronic layer comprising at least one electrochemical sensor, a microcontroller, and a transceiver antenna coil;

a microfluidic management layer; and

a vapor porous, top protective layer;

wherein the macrofluidic, double-sided adhesive layer is removably adhered to a surface;

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

wherein the microfluidic management layer circumferentially surrounds the at least one electrochemical sensor of the electronic layer;

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

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

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

3. The device of claim 1, wherein the surface that the macrofluidic, double-sided adhesive layer is removably adhered to is skin.

4. The device of claim 3, wherein the skin is mammalian skin.

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

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

7. The device of claim 6, wherein the at least one biomarker of the biological fluid includes electrolytes, small molecules, proteins, and/or metabolites.

8. The device of claim 1, wherein the microcontroller receives user data to customize rates at which the at least one biological fluid is sensed and analyzed, to toggle circuit power of the microcontroller, communicate via multiple channels and/or buses with a computing device biological fluid data via multiple protocols concurrently in real-time to a computing device with software operable thereon for receiving, storing, and analyzing the biological fluid data, and define data collection along with transmission characteristics in real time for optimization of power and the electrochemical sensor features for a user, wherein the user data includes height, weight, gender, fitness level, conditioning level, age, transepidermal water loss, metabolic disorder, environmental temperature, environmental pressure, environmental sodium concentration, environmental chlorine concentration, and/or combinations thereof.

9. The device of claim 1, wherein the device wirelessly transmits the sensed and stored biological fluid data via multiple protocols concurrently in real-time to a computing device with software operable thereon for receiving, storing, and analyzing the biological fluid data.

10. The device of claim 8, wherein the computing device calculates biological fluid concentration ratios of the biological fluid and provides visual representations of the received and analyzed data on a graphic user interface of the computing device.

11. The device of claim 1, wherein the fluid sensor apparatus further includes gold probes or electrodes.

12. A device for analyzing biological fluid from a human and transmitting and storing biological fluid data for human performers in demanding conditions, wherein the device is for extended wear by a human comprising:

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

a skin adhesive layer including at least one laser cut, macrofluidic pore; and

an electronic layer including at least one electrochemical sensor unit that includes at least one electrode;

wherein the skin adhesive layer is operable to allow the biological fluid to flow through the at least one macrofluidic pore; and

wherein the at least one electrode of the at least one electrochemical sensor unit is operable to detect at least one biomarker of the biological fluid when the biological fluid comes into contact with the at least one electrode.

13. The device of claim 12, wherein the fluid sensor apparatus further includes a woven textile protective top layer, wherein the woven textile protective top layer facilitates evaporation of the biological fluid after the biological fluid contacts the at least one electrode of the at least one electrochemical sensor unit.

14. The device of claim 12, wherein the biological fluid is sweat.

15. The device of claim 12, wherein the fluid sensor apparatus further includes a microcontroller that is operable to receive input data from at least one portable device.

16. The device of claim 15, wherein the input data received by the microcontroller comprises information about one or multiple users including height, weight, gender, fitness or conditioning level, age, trans epidermal weight loss, and/or metabolic disorder.

17. The device of claim 12, wherein the at least one electrochemical sensor unit is further operable to measure characteristics of the at least one biomarker including concentration, molarity, osmolarity, and/or osmolality.

18. A device for analyzing biological fluid from a human and transmitting and storing biological fluid data from the human, wherein the device is for extended wear by a human under demanding conditions, comprising:

a fluid sensor apparatus for sensing and analyzing at least one biological fluid;

wherein the fluid sensor apparatus includes an electronic layer including at least one electrochemical sensor unit that includes at least one electrode; and

wherein the at least one electrode includes an ionophore polymer coating.

19. The device of claim 18, wherein the ionophore polymer coating is approximately 2 microliters and does not extend more than 0.5 millimeters from the edge of the at least one electrode such that the ionophore polymer coating remains in place for at least 72 hours and provides for at least 8 hours of continuous use under demanding conditions, wherein the demanding conditions include pressure of about 21.7 psi and/or temperatures ranging from about 0 degrees Fahrenheit to about 100 degrees Fahrenheit.

20. The device of claim 18, wherein the at least one electrode is operable to detect at least one biomarker of the biological fluid when the biological fluid comes into contact with the electrode.