US-20260123857-A1 - DEVICE FOR MEASURING BIOLOGICAL FLUIDS

US20260123857A1US 20260123857 A1US20260123857 A1US 20260123857A1US-20260123857-A1

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.

Inventors

Sten Adam Nyberg
Dalton Pont
Adam Pizer
John V. Chiochetti

Assignees

CoreSyte, Inc.

Dates

Publication Date: 20260507
Application Date: 20260102

Claims (20)

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; and a top protective layer; wherein the macrofluidic layer is detachable to a surface; 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; and wherein the at least one output datum is calculated 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.
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 layer is adapted to be removably adhered to is skin.
4 . The device of claim 1 , wherein the electronic layer is intimately adhered to the macrofluidic layer.
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 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.
16 . The device of claim 1 , 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 top protective layer is adhered to the macrofluidic layer and completely covers the electronic layer.
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; and a top protective layer; wherein the macrofluidic layer is configured to be adhered to a surface; wherein the top protective layer covers the electronic 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 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; and wherein the at least one output datum is calculated 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.
20 . A device for analyzing biological fluid and transmitting and storing biological fluid data 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; and a top protective layer; wherein the at least electrochemical sensor of the electronic layer is configured to face an exterior layer of skin; wherein the top protective layer covers the electronic layer; wherein the top protective layer is 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 at least one biological fluid; wherein the at least one electrochemical sensor houses at least one electrode; wherein the at least one electrode is 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; and wherein the at least one output datum is calculated using an estimated body surface area of a 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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is related to and claims priority from the following U.S. patents and patent applications. This application is a continuation of U.S. application Ser. No. 18/677,284, filed May 29, 2024, which is a continuation of U.S. application Ser. No. 17/864,079, filed Jul. 13, 2022, which is a continuation of U.S. application Ser. No. 16/448,587, filed Jun. 21, 2019, which is a continuation of U.S. application Ser. No. 15/839,957, filed Dec. 13, 2017, which is a continuation-in-part of U.S. application Ser. No. 15/487,046, filed Apr. 13, 2017, a continuation-in-part of U.S. Application Ser. No. 15/442,305, filed Feb. 24, 2017, and a continuation-in-part of U.S. application Ser. No. 15/177,667, filed Jun. 9, 2016. U.S. application Ser. No. 15/487,046 is a continuation-in-part of U.S. application Ser. No. 15/177,703, filed Jun. 9, 2016, which is a continuation-in-part of U.S. application Ser. No. 15/019,006, filed Feb. 9, 2016, which claims priority from U.S. Provisional Ser. No. 62/130,047 , filed Mar. 9, 2015. U.S. application Ser. No. 15/442,305 is a continuation-in-part of U.S. application Ser. No. 15/177,686, filed Jun. 9, 2016, which is a continuation-in-part of U.S. application Ser. No. 15/014,526, filed Feb. 3, 2016, which claims priority from U.S. Provisional Ser. No. 62/130,039 , filed Mar. 9, 2015. U.S. application Ser. No. 15/177,667 is a continuation-in-part of U.S. Application No. Ser. No. 15/040,319, filed Feb. 10, 2016, which claims priority from U.S. Provisional Ser. No. 62/130,030 , filed Mar. 9, 2015. Each of the U.S. Applications mentioned above is incorporated by reference herein in its entirety. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention is generally directed to a fluid sensor device, and more particularly to a device for sensing and collecting biological fluid inputs. 2. Description of the Prior Art Generally, biomarkers from biological fluid have significant prognostic and/or diagnostic utility, such as predicting disease, nutritional imbalance, or psychological or physical stress; however, many of the most utilized biomarkers are collected from blood. The ability to predict events through non-invasive means, such as sweat detection, provides great utility to persons under physical stress, particularly individuals in the process of physical activity or exercise. The ability to monitor sweat biomarkers in real time and continuously during activity allows an individual to make informed decisions regarding hydration, nutrition, and exertional status, and recovery, all variables that moderate physical performance. For example, hydration status is a predictor of physical performance; dehydration as low as 1% of body mass can impair performance. Prior art detection and treatment, as shown in FIG. 1, is currently at the stages of when symptoms present, performance degrades, and/or injury presents. Determining hydration through sweat biomarkers before dehydration symptoms present has many benefits, such as reducing fatigue, cramps, and headaches. Therefore, developing a device and system for non-invasively obtaining biomarkers, such as through sweat, is needed. Sweat contains a multitude of biomarkers; any substance aqueously dissolvable in the blood can present in the sweat by way of eccrine glands. The sweat biomarkers can be small molecules (molecular weight <900 Daltons), proteins, metabolites, and/or electrolytes. Well-known electrolytes in sweat are sodium and potassium. As shown in FIG. 2, potassium concentration is not dependent upon sweat rate due to the passive diffusive transport of potassium, while sodium and chloride concentrations in sweat are dependent upon sweat rate due to the active transport of sodium. Thus, monitoring sodium or chloride concentrations is an accurate, indirect means of indicating hydration status of an individual. Therefore, developing a sweat biomarker device that can communicate to an individual real-time biomarker data is needed. Prior art documents include the following: U.S. Pat. No. 6,198,953 for method and system for continuous sweat collection and analysis by inventors Webster, et al., filed Mar. 11, 1999 and issued Mar. 6, 2001, is directed to a method and system providing especially for continuously obtaining and analyzing, on a real time basis, sweat from a selected area of skin on the body of a person, especially a neonate, being diagnosed for cystic fibrosis, by causing sweating of the selected area of skin, by placing an electrically positive iontophoretic electrode device of a set of said devices over the selected area of skin preferably within a previously placed receiving and holding device which, following the induction of sweat and removal of the electrically positive iontophoretic electrode device, receives a sweat-sensing electrode device that continuously sends electrical signals to sweat analysis circuitry for providing a digital readout of the ionic composi