# US 11,998,319 B2 · Device for measuring biological fluids > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,319 B2 - Document ID: US11998319B2 - Status: Granted - Kind: B2 - Application number: 17/864,079 - Filed: 2022-07-13 - Published: 2022-11-03 - Granted: 2024-06-04 - Earliest claimed: 2015-03-09 - Assignees: CoreSyte, Inc. - Applicants: CoreSyte, Inc. - Inventors: Sten Adam Nyberg; Dalton Pont; Adam Pizer; John V. Chiochetti - Web page: https://patentgrep.com/patent/US11998319B2 ## CPC - A61B 5/14517: {for sweat} - A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes} - A61B 5/1477: non-invasive - A61B 5/4266: {sweat secretion} - A61B 5/6833: {Adhesive patches} - A61B 10/0064: {for taking sweat or sebum samples (measuring sweat production A61B5/4266)} - B23K 1/0016: {Soldering of electronic components} - B23K 1/008: Soldering within a furnace (B23K1/012 takes precedence) - B23K 26/38: by boring or cutting - B23K 26/384: of specially shaped holes - B23K 26/389: {of fluid openings, e.g. nozzles, jets} - B23K 26/402: involving non-metallic material, e.g. isolators - H05K 1/165: {incorporating printed inductors} - A61B 5/0017: {transmitting optical signals} - A61B 2560/0252: using ambient temperature - A61B 2562/0295: Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 - A61B 2562/12: Manufacturing methods specially adapted for producing sensors for in-vivo measurements - A61B 2562/125: characterised by the manufacture of electrodes - A61B 2562/164: the sensor is mounted in or on a conformable substrate or carrier - A61B 2562/166: the sensor is mounted on a specially adapted printed circuit board - B23K 2101/36: Electric or electronic devices - B23K 2101/42: Printed circuits - B23K 2103/172: {wherein at least one of the layers is non-metallic} - B23K 2103/42: {Plastics other than composite materials} - H05K 2201/10151: Sensor - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - B23K: SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM - H05K: PRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS ## 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 ### Claim 1 A device for analyzing biological fluid from a human and transmitting and storing biological fluid data from the human 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 layer; an electronic layer comprising at least one electrochemical sensor, a microcontroller, and a transceiver antenna coil; a microfluidic management layer; and a top protective layer; wherein the macrofluidic layer is adapted to be removably adhered to a surface; wherein the electronic layer is intimately adhered to the macrofluidic layer; wherein the microfluidic management layer circumferentially surrounds the at least one electrochemical sensor of the electronic layer; wherein the top protective layer is placed on and completely covers the microfluidic management layer and the electronic layer; wherein the top protective layer is adhered to the macrofluidic 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 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. ### Claim 2 (depends on 1) The device of claim 1, wherein the fluid sensor apparatus is flexible. ### Claim 3 (depends on 1) The device of claim 1, wherein the surface that the macrofluidic layer is adapted to be removably adhered to is skin. ### Claim 4 (depends on 1) The device of claim 1, wherein the at least one_biological fluid includes sweat. ### Claim 5 (depends on 1) 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. ### Claim 6 (depends on 1) 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. ### Claim 7 (depends on 1) The device of claim 1, wherein the at least one active electrode includes an ionophore polymer coating. ### Claim 8 (depends on 7) 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. ### Claim 9 (depends on 1) 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. ### Claim 10 (depends on 1) 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. ### Claim 11 (depends on 1) 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. ### Claim 12 (depends on 1) 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. ### Claim 13 (depends on 1) 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. ### Claim 14 (depends on 1) 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. ### Claim 15 (depends on 1) The device of claim 1, 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. ### Claim 16 (depends on 1) The device of claim 1, wherein the input data is received from a remote transceiver device. ### Claim 17 (depends on 1) The device of claim 1, wherein the fluid sensor apparatus wirelessly transmits the at least one output datum to a remote transceiver device. ### Claim 18 (depends on 1) The device of claim 1, wherein the device is for extended wear by the human under demanding conditions, 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. ### Claim 19 A device for analyzing biological fluid from a human and transmitting and storing biological fluid data from the human 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 layer; an electronic layer comprising at least one electrochemical sensor, a microcontroller, and a transceiver antenna coil; a microfluidic management layer; and a top protective layer; wherein the macrofluidic layer is configured to be intimately adhered to an exterior layer of human skin; wherein the microfluidic management layer is positioned between the macrofluidic 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 configured to face the exterior layer of human skin; wherein the top protective layer is placed on and completely covers the microfluidic management layer and the electronic layer; wherein the top protective layer is intimately adhered to the macrofluidic 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 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. ### Claim 20 A device for analyzing sweat from a human and transmitting and storing sweat data from the human comprising: a fluid sensor apparatus for sensing and analyzing sweat, wherein the fluid sensor apparatus is multi-layered, including: a macrofluidic layer; an electronic layer comprising at least one electrochemical sensor, a microcontroller, and a transceiver antenna coil; a microfluidic management layer; and a top protective layer; wherein the macrofluidic layer is configured to be intimately adhered to an exterior layer of human; wherein the microfluidic management layer is positioned between the macrofluidic 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 configured to face the exterior layer of human skin; wherein the 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 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 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.