System and method for measuring biological fluid biomarkers

• US 9,883,827 B2
• Filed: 02/24/2017
• Issued: 02/06/2018
• Est. Priority Date: 03/09/2015
• Status: Active Grant

• Current Assignee: CoreSyte, Inc.
• Original Assignee: CoreSyte, Inc.
• Inventors: Nyberg, Sten Adam, Pont, Dalton
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): MESSERSMITH, ERIC J
• Application Number:
  US15/442,305
• Publication Number:
  US 20170156641A1
• Time in Patent Office: 347 Days
• 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 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 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• 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 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/4266 sweat secretion
• CPC Class Codes: A61B 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Systems and methods of analyzing biological fluid biomarkers, calculating biomarker data, transmitting data to a transceiver device, and storing the data and/or analytics in a database and/or on at least one remote computer server.

Claims

1. A system for analyzing sweat from a human and transmitting and storing sweat data from the human comprising:

an apparatus for sensing and analyzing sweat, wherein the apparatus includes an electronic layer comprising at least one electrochemical sensor, a microcontroller, and a transceiver antenna coil;

at least one remote transceiver device; and

at least one remote computer server;

wherein the apparatus analyzes at least one sweat biomarker, calculates at least one output datum of the at least one sweat biomarker using at least one algorithm, and transmits the at least one output datum to the at least one remote transceiver device;

wherein the apparatus is calibrated using a personalization factor;

wherein the personalization factor is initialized to a value of 1;

wherein the at least one remote transceiver device updates the value of the personalization factor using at least a weight of the user before a physical activity and a weight of the user after the physical activity;

wherein the at least one remote transceiver device transmits the at least one output datum to the at least one remote computer server or at least one remote computing device or database for storage;

wherein the apparatus and the at least one remote transceiver device have real-time or near-real-time two-way communication;

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

wherein the apparatus is flexible and further includes;

a macrofluidic, double-sided adhesive layer;

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 one electrochemical sensor of the electronic layer is facing the exterior layer of human skin;

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

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

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

2. The system of claim 1, wherein the at least one sweat biomarker includes small molecules, proteins, hormones, metabolites, and/or electrolytes.

3. The system of claim 1, wherein the at least one output datum includes but is not limited to concentrations, such as molarity, osmolarity, and osmolality, and/or descriptive statistics, such as averages, ratios, and trends, all of which may be categorized based on a sub-range within a larger physiological range of the at least one biomarker.

4. The system 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.

5. The system of claim 1, wherein the at least one remote transceiver device transmits the personalization factor to the at least one remote computer server or the at least one remote computing device or database for storage.

6. The system of claim 1, wherein the apparatus calculates a volume of sweat lost 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.

7. The system of claim 1, wherein the at least one algorithm calculates the at least one output datum using input data, wherein the input data includes gender, age, and a maximum rate of oxygen consumption for the human (VO₂ max).

8. The system of claim 1, wherein the two-way communication further comprises commands, electrode calibration, microcontroller software updates, new or updated algorithms, new or updated modifying variables for algorithms, microcontroller health properties, error codes, electrode maintenance or malfunction, or a combination thereof.

9. The system 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.

10. The system of claim 1, wherein the electronic layer is fabricated on a substrate, wherein a conductive trace is in a first ring around the 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 a different material than the substrate.

11. The system 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 the 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.

12. The system of claim 1, wherein the at least one output datum is transmitted from the apparatus to the at least one remote computer device through wireless network communication by the transceiver antenna coil of the apparatus.

13. The system of claim 1, wherein the wireless network communication is via Bluetooth, radiofrequency, ZigBee, Wi-Fi, or near field communication.

14. A system for continuously analyzing sweat from a human in real-time and transmitting and storing sweat data from the human comprising:

an apparatus for sensing and analyzing sweat, wherein the apparatus includes an electronic layer comprising at least one electrochemical sensor, a microcontroller, and a transceiver antenna coil;

at least one remote transceiver device; and

at least one remote computer server;

wherein the apparatus continuously analyzes at least one sweat biomarker in real-time, calculates at least one output datum of the at least one sweat biomarker using at least one algorithm, and transmits the at least one output datum to the at least one remote transceiver device;

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;

wherein the apparatus is calibrated using a personalization factor;

wherein the personalization factor is initialized to a value of 1;

wherein the at least one remote transceiver device updates the value of the personalization factor using at least a weight of the user before a physical activity and a weight of the user after the physical activity;

wherein the at least one remote transceiver device transmits the at least one output datum to the at least one remote computer server or at least one remote computing device or database for storage;

wherein the apparatus and the at least one remote transceiver device have real-time or near-real-time two-way communication;

wherein the electrochemical sensor has at least one reference electrode and at least one active electrode;

wherein the at least one active electrode has an ionophore polymer coating;

wherein the apparatus is flexible and further includes;

a macrofluidic, double-sided adhesive layer;

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 one electrochemical sensor of the electronic layer is facing the exterior layer of human skin;

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

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

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

15. A method for analyzing sweat from a human and transmitting and storing sweat data from the human, the method comprising:

providing an apparatus for sensing and analyzing sweat, wherein the apparatus includes an electronic layer comprising at least one electrochemical sensor, a microcontroller, and a transceiver antenna coil;

at least one remote transceiver device; and

at least one remote computer server;

wherein the at least one remote transceiver device and the apparatus are operable for two-way cross-communication in real-time or near-real-time;

the at least one electrochemical sensor sensing at least one biomarker of the sweat, which creates a voltage;

the microcontroller converting the at least one biomarker of the sweat into at least one output datum using at least one algorithm;

the at least one remote transceiver device inputting modifying variables into the at least one algorithm via the two-way communication with the apparatus;

the transceiver antenna coil transmitting the at least one output datum to the at least one remote transceiver device via the two-way communication with the apparatus;

the at least one remote transceiver device calibrating the apparatus using a personalization factor, wherein the personalization factor is initialized to a value of 1, and

wherein the at least one remote transceiver device updates the value of the personalization factor using at least a weight of the user before a physical activity and a weight of the user after the physical activity;

the at least one remote transceiver device sharing or transmitting the at least one datum with the at least one remote computer server or at least one remote computing device or database for storage; and

wherein the apparatus is flexible and further includes;

a macrofluidic, double-sided adhesive layer;

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 one electrochemical sensor of the electronic layer is facing the exterior layer of human skin;

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

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

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

16. The method of claim 15, wherein the at least one biomarker of the sweat includes small molecules, proteins, hormones, metabolites, and/or electrolytes.

17. The method of claim 15, wherein the at least one output datum includes but is not limited to concentrations, such as molarity, osmolarity, and osmolality, and/or descriptive statistics, such as averages, ratios, and trends, all of which may be categorized based on a sub-range within a larger physiological range of the at least one biomarker.

18. The method of claim 15, wherein the at least one output datum is transmitted from the apparatus to a remote computer device through wireless network communication by the transceiver antenna coil of the apparatus.

19. The method of claim 18, wherein the wireless network communication is via Bluetooth, radiofrequency, ZigBee, Wi-Fi, or near field communication.

20. The method of claim 15, 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.