Device for measuring biological fluids

• US 10,327,676 B2
• Filed: 12/13/2017
• Issued: 06/25/2019
• Est. Priority Date: 03/09/2015
• Status: Expired due to Fees

• Current Assignee: CoreSyte, Inc.
• Original Assignee: CoreSyte, Inc.
• Inventors: Nyberg, Sten Adam, Pont, Dalton, Pizer, Adam, Chiochetti, John V.
• Primary Examiner(s): Messersmith, Eric J
• Application Number:
  US15/839,957
• Publication Number:
  US 20180153452A1
• Time in Patent Office: 559 Days
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/0017 transmitting optical signals transmission by light H04B10/00
• 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 5/4266 sweat secretion
• CPC Class Codes: A61B 5/6833 Adhesive patches

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 the 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 adapted to be 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 the electronic layer;

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

wherein the at least one electrochemical sensor houses at least one standard electrode and at least one active electrode;

wherein the at least one electrochemical sensor of the electronic layer is operable to detect and analyze at least one biomarker of the at least one biological fluid;

wherein the fluid sensor apparatus calculates at least one output datum of the at least one biomarker of the at least one biological fluid using at least one algorithm; and

wherein the fluid sensor apparatus is calibrated using a personalization factor, wherein the personalization factor is initialized to a value of 1, and wherein the personalization factor is updated using at least a weight of the user before a physical activity and a weight of the user after the physical activity.

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 adapted to be removably adhered to is skin.

4. The device of claim 1, wherein the at least one biological fluid includes sweat.

5. The device of claim 1, wherein the at least one biomarker of the at least one biological fluid includes electrolytes, small molecules, proteins, and/or metabolites.

6. The device of claim 1, wherein the at least one standard electrode and/or the at least one active electrode are silver, zinc, copper, gold, platinum, rhodium, carbon, or a combination thereof.

7. The device of claim 1, wherein the at least one active electrode includes an ionophore polymer coating.

8. The device of claim 7, wherein the ionophore polymer coating is approximately 2 microliters and does not extend more than 0.5 millimeters from the exterior edge of the at least one active electrode.

9. The device of claim 1, wherein the electronic layer is fabricated on a substrate, wherein a conductive trace is in a first ring around at least one active electrode, wherein the conductive trace in the first ring around the at least one active electrode does not contact the at least one active electrode, wherein a soldermask, a printed ink, or a non-conductive material is printed, deposited, or adhered on the substrate in a second ring around the at least one active electrode, wherein the second ring around the at least one active electrode is inside the first ring around the at least one active electrode, wherein the first ring around the at least one active electrode does not contact the second ring around the at least one active electrode, wherein an ionophore polymer coating is applied to the at least one active electrode via liquid deposition such that the ionophore polymer coating completely covers the at least one active electrode and is contained within the second ring formed by the soldermask, the printed ink, or the non-conductive material, and wherein the non-conductive material is formed of a different material than the substrate.

10. The device of claim 1, wherein the electronic layer is fabricated on a substrate, wherein the substrate includes a well, wherein a conductive trace is in a ring around the well, wherein the conductive trace does not contact the well, wherein at least one active electrode is within the well, and wherein an ionophore polymer coating is applied to the at least one active electrode via liquid deposition such that the ionophore polymer coating completely covers the at least one active electrode and the ionophore polymer coating is contained within the well on the substrate.

11. The device of claim 1, wherein the at least one biomarker of the at least one biological fluid is sodium, potassium, chloride, oxygen, glucose, calcium, ammonium, copper, magnesium, iron, zinc, lactate, creatinine, uric acid, urea, ethanol, amino acids, hormones, steroids, proteins, catecholamines, and/or interleukins.

12. The device of claim 1, wherein the fluid sensor apparatus is operable to sense sodium and/or chloride in a dynamic range from about 0 mM to about 120 mM.

13. The device of claim 1, wherein the fluid sensor apparatus is operable to sense potassium in a dynamic range from about 0 mM to about 40 mM.

14. The device of claim 1, wherein the at least one electrochemical sensor is further operable to measure characteristics of the at least one biomarker including concentration, molarity, osmolarity, and/or osmolality.

15. The device of claim 1, wherein the at least one algorithm calculates the at least one output datum using an estimated body surface area of the human and input data, wherein the input data includes at least a height and a weight of the human, and wherein the height and the weight of the human are used to estimate the estimated body surface area of the human.

16. The device of claim 15, wherein the input data is received from a remote transceiver device.

17. The device of claim 1, wherein the fluid sensor apparatus wirelessly transmits the at least one output datum to a remote transceiver device.

18. The device of claim 1, wherein the demanding conditions include temperatures between about −

10 degrees Fahrenheit and about 110 degrees Fahrenheit, wet conditions, exposure to pool chemicals, exposure to naturally occurring elements and compounds in seawater, environments up to about 40% salinity, pressure of about 173.4 psi, pH levels from about 7 to about 8, and/or altitudes up to about 30,000 feet.

19. 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 the 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 intimately adhered to an exterior layer of human skin;

wherein the microfluidic management layer is positioned between the macrofluidic, double-sided adhesive layer and the electronic layer;

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

wherein the at least electrochemical sensor of the electronic layer is facing the exterior layer of human skin;

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

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

wherein the at least one electrochemical sensor of the electronic layer is operable to detect and analyze at least one biomarker of the biological fluid;

wherein the at least one electrochemical sensor houses at least one standard electrode and at least one active electrode;

wherein the at least one standard electrode and/or the at least one active electrode are silver, zinc, copper, gold, platinum, rhodium, carbon, or a combination thereof;

wherein the at least one electrochemical sensor of the electronic layer is operable to detect and analyze at least one biomarker of the at least one biological fluid;

wherein the fluid sensor apparatus calculates at least one output datum of the at least one biomarker of the at least one biological fluid using at least one algorithm; and

wherein the fluid sensor apparatus is calibrated using a personalization factor, wherein the personalization factor is initialized to a value of 1, and wherein the personalization factor is updated using at least a weight of the user before a physical activity and a weight of the user after the physical activity.

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

a fluid sensor apparatus for sensing and analyzing sweat, 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 intimately adhered to an exterior layer of human skin;

wherein the microfluidic management layer is positioned between the macrofluidic, double-sided adhesive layer and the electronic layer;

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

wherein the at least electrochemical sensor of the electronic layer is facing the exterior layer of human skin;

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

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

wherein the at least one electrochemical sensor of the electronic layer is operable to detect and analyze at least one biomarker of the sweat;

wherein the at least one electrochemical sensor houses at least one standard electrode and at least one active electrode;

wherein the at least one standard electrode and/or the at least one active electrode are silver, zinc, copper, gold, platinum, rhodium, carbon, or a combination thereof;

wherein the at least one electrochemical sensor of the electronic layer is operable to detect and analyze at least one biomarker of the sweat;

wherein the fluid sensor apparatus calculates at least one output datum of the at least one biomarker of the sweat using at least one algorithm; and

wherein the fluid sensor apparatus is calibrated using a personalization factor, wherein the personalization factor is initialized to a value of 1, and wherein the personalization factor is updated using at least a weight of the user before a physical activity and a weight of the user after the physical activity.