Non-invasive hydration and electrolyte monitoring

Abstract

A system for detecting salt ion concentration, comprising a device having a sensor and an electronic circuit, the sensor having a carbon printed electrode disposed on a flexible substrate having an adhesive disposed on one side (back side) thereof, and the electronic circuit for generating a pulse signal stimulus and measuring salt concentration to determine the hydration level of a person or an organism, wherein the device is a wearable device. Since the electrode is a carbon printed electrode and is flexible, it can be made into different shapes and change the area as needed.

Description

[0001] Related Applications

[0002] This application claims priority to U.S. Non-Provisional Application No. 17 / 032,810, filed on September 25, 2020, entitled “Non-Invasive Hydration and Electrolyte Monitoring,” and U.S. Provisional Application No. 62 / 910,165, filed on October 7, 2019, entitled “Electrolyte Monitoring Device,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to a portable ion monitoring device, and more particularly to local monitoring of ion concentration in body fluids. Background Art

[0004] Dehydration occurs when a person uses, or consumes, more fluids than they take in and the body does not have enough water and other fluids to carry out its normal functions. If a person does not replace the fluids they consume, they can become dehydrated. Anyone can become dehydrated, but the condition is especially dangerous for young children and older adults. The most common causes of dehydration in young children are severe diarrhea and vomiting. Older adults naturally have less water in their bodies and may also have illnesses or take medications that increase their risk of dehydration. This means that even minor illnesses, such as infections that affect the lungs or bladder, can cause dehydration in older adults.

[0005] Dehydration can also occur in people of any age if they do not drink enough water during hot weather, especially when a person is exercising vigorously. Mild to moderate dehydration can usually be reversed by drinking more water, but severe dehydration requires immediate medical attention.

[0006] Good hydration is essential for health and wellness. Every cell in the human body requires water. Hydration is central to the most basic physiological functions, such as regulating blood pressure and body temperature, hydration, and digestion.

[0007] As dehydration increases, physical and mental performance decreases. Heart rate and body temperature increase, and the perception of exertion intensity increases, especially when exercising in the heat. Research shows that losing 2% of body weight in fluid is enough to cause a noticeable decrease in physical performance (i.e. 1.4 kg for a 70 kg athlete). Dehydration of more than 2% of body weight increases the risk of nausea, vomiting, diarrhea, and other gastrointestinal problems during exercise.

[0008] U.S. Patent Application Publication 20160338639A1 discloses various embodiments of flexible hydration sensors that can be implemented in wearable devices. The hydration monitoring device may include at least one flexible electrode comprising a plurality of silver nanowires embedded in a polydimethylsiloxane (PDMS) substrate. The processing circuit may be configured to measure the hydration level of an individual wearing the hydration monitoring device based at least in part on a measurement of the individual's skin impedance. In some embodiments, the hydration monitoring device may also generate a hydration metric based on the hydration level and display the hydration metric.

[0009] US Patent 10092203B2 discloses a wearable device that includes electrical contacts to detect voltage or other biological signals when the device is mounted on the skin of a wearer. Impedance between a pair of electrical contacts can be detected, and the device can be operated based on the detected impedance. The detected impedance can be used to determine physiological parameters, such as determining galvanic skin response, skin perfusion, skin hydration level, or other physiological parameters.

[0010] US Patent 8734341B2 discloses a method and apparatus for measuring a user's hydration level based on measuring the user's saliva. A compound is configured to change the color of at least a portion of a water-permeable material due to contact with saliva, and the change is observable from at least a portion of a piece of water-impermeable material. The measurement is then used to indicate whether the user is properly hydrated.

[0011] US Patent 7783344B2 discloses a system and technique for monitoring hydration. In one embodiment, the method includes measuring the electrical impedance of an area of ​​an object to obtain an impedance measurement result, and wirelessly transmitting the data to a remote device. The probe for measuring impedance can be in the form of a patch, adhesively fixed to the object.

[0012] WO2016030869A1 discloses a wearable system, which is based on in-situ four-probe impedance measurement at different signal frequencies, and is used to locally monitor at least one physiological parameter reflecting hydration status, such as skin conductivity, sweat or ion concentration characteristics in red blood cells. The system includes a flexible substrate suitable for being directly or indirectly fixed to the skin and a plurality of conductive electrodes designed to contact the body, and is capable of realizing four-probe measurement of bioimpedance of tissue and / or skin at one or more tissue sites.

[0013] Skin impedance is a commonly used method for measuring skin hydration level in the above-mentioned prior art. It is not easy to explain changes in skin impedance. First, skin impedance can change suddenly due to internal or psychological factors, which is known as galvanic skin reflex (GSR). There are also large site differences among individuals, and the values ​​of a given skin area are not stable throughout the day or from day to day. In addition, the differences between individuals are huge. The impedance between the electrical contacts and the skin and / or subcutaneous tissue may be related to various factors of the skin, such as the thickness of the skin, the fat content of the skin, the keratin content of the skin, the skin type (e.g., hairless skin), the moisture and / or hydration level on / in the skin, the perfusion level of the skin, or other characteristics of the skin. Impedance changes over time; for example, due to the accumulation of skin moisture (e.g., sweat or other liquids) under and / or near the electrical contacts mounted on the skin, the impedance decreases over time.

[0014] Accurate and convenient topical hydration monitoring devices, such as wearable hydration monitoring devices, are not readily available. While some wearable hydration monitoring devices have been developed, they are often inaccurate, difficult to clean, require invasive techniques, and are not reusable. Other monitoring devices encounter difficulties with skin interfering with measurements and are unable to expose the sensor to sufficient amounts of body fluids for accurate hydration monitoring.

[0015] Therefore, there is a need for a device that can monitor the hydration of an organism in real time and over a long period of time, using a method that reduces the interference of the input signal on the output being measured and takes into account the influence of the environment, factors specific to each organism (e.g., the organism's weight, height, activity, etc.). More specifically, there is a need for a low-power wearable or portable or stand-alone device that can take into account the influence of surrounding environmental conditions and factors specific to each organism. Summary of the invention

[0016] A device comprises: a sensor comprising an electrode pair located on a flexible substrate; and an ion sensing circuit; wherein the sensor is electrically connected to the ion sensing circuit, the ion sensing circuit comprises a microcontroller that generates a pulse signal stimulus; and the device can be used to detect the ion concentration in a fluid of an object through the sensor.

[0017] A sensor, comprising a sensor, comprising an electrode pair, the electrode pair being located on a flexible substrate; and an ion sensing circuit, the ion sensing circuit comprising: a microcontroller; an electrode pair; at least a first resistor; a capacitor electrically connected in series with the at least first resistor; at least a second resistor electrically connected in parallel with the electrode pair; a first node, a read node electrically connected to the first node; and a second node; wherein the first node establishes a first electrical connection between the capacitor and the parallel connection of the at least second resistor with the electrode pair; the second node establishes a second electrical connection between the capacitor and the parallel connection of the at least second resistor with the electrode pair; the sensor is electrically connected to the ion sensing circuit, the ion sensing circuit comprises a microcontroller that generates a pulse signal stimulus; and the sensor can be used to detect the ion concentration in the fluid of an object through the sensor.

[0018] A database includes: conductivity information of at least one fluid of an object; real-time ion concentration information of the at least one fluid acquired over a period of time; measurement information of at least one parameter of the object; characteristic information of the object; environmental parameters that affect sensor readings; location data; timestamp of when a measurement occurs or is performed; physiological state of the object; and data indicators.

[0019] A method, comprising: fixing a wearable device to the surface of an object; applying a pulsating direct current with a predetermined frequency to a sensor through an energy source to provide excitation; determining the ion concentration of a fluid in real time over a period of time, which includes at least a first reading and a second reading; communicating the ion concentration of the fluid over a period of time with a database; extracting physiological state information of the object based on the difference between the first ion concentration and the second ion concentration; and displaying the physiological state information of the object through at least one of a wearable device or a smart handheld device.

[0020] A system comprises: a sensor, the sensor comprising: an electrode pair, the electrode pair being located on a flexible substrate; and an ion sensing circuit, the ion sensing circuit comprising: a microcontroller; an electrode pair; at least a first resistor; a capacitor electrically connected in series with the at least first resistor; at least a second resistor electrically connected in parallel with the electrode pair; a first node, a reading node electrically connected to the first node; and a second node; wherein the first node establishes a first electrical connection between the capacitor and the parallel connection of the at least second resistor with the electrode pair; the second node establishes a second electrical connection between the capacitor and the parallel connection of the at least second resistor with the electrode pair; the sensor is electrically connected to the ion sensing circuit, the ion sensing circuit comprises a microcontroller for generating a pulse signal stimulus; the sensor can be used to detect the ion concentration in the fluid of an object through the sensor, and the system comprises at least a processor, a memory communicating with the processor, a communication module, a display and a database, wherein the sensor communicates with the system through a wireless communication device. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In the present disclosure, reference is made to the drawings that form a part of the present disclosure. In the drawings, similar reference numerals generally identify similar elements unless the context indicates otherwise. The various embodiments described in the specification, drawings, and claims are illustrative rather than restrictive. Other embodiments may be used and other changes may be made without departing from the spirit or scope of the subject matter presented herein. It should be understood that the various aspects of the present disclosure as generally described herein and shown in the drawings may be arranged, replaced, combined, separated, and designed in a variety of different configurations, all of which are considered herein. The embodiments are shown in the drawings by way of example and not limitation, wherein the same reference numerals indicate similar elements.

[0022] The following detailed description is read in conjunction with the drawings, wherein like reference numerals refer to like parts throughout the several views.

[0023] Figure 1a Pulses that may be used in embodiments of the present invention are depicted.

[0024] Figure 1b A circuit for generating pulses that may be used in embodiments of the present invention is depicted.

[0025] Figure 2a Depicted is a top view of an electrode that may be used in embodiments of the present invention.

[0026] Figure 2b Depicted is a side view of an electrode that may be used in embodiments of the present invention.

[0027] Figure 3A wearable hydration monitoring device having electrodes secured to a band of a wearable device is depicted according to one embodiment.

[0028] Figure 4 A wearable hydration monitoring device is depicted secured to a band of a wearable device having a display, according to one embodiment.

[0029] Figure 5 A band according to one embodiment is depicted having a hydration monitoring device attached thereto such that electrodes of the device are in contact with the skin of a wearer of the band.

[0030] Figure 6 A circuit diagram of a sensor used in an embodiment of the present invention is shown.

[0031] Figure 7a Depicted is a bottom view of a hydration monitoring device or sensor according to one embodiment, wherein the device has a flat, horizontal structure.

[0032] Figure 7b Depicted is a top view of a hydration monitoring device or sensor according to one embodiment, wherein the device has a flat, horizontal structure.

[0033] Figure 8 Depicted is the interior of a hydration monitoring device showing the electronics and circuitry connected to the electrodes, according to one embodiment.

[0034] Figure 9a A standalone hydration monitoring device with an integrated display is depicted according to one embodiment.

[0035] Figure 9b Depicted is the back side of a standalone hydration monitoring device with an integrated display, according to one embodiment.

[0036] Fig.10 Depicted is a graph of data collected to illustrate the Nil Per Os (NPO) test at varying water intakes during exercise.

[0037] Fig.11 Depicted are sensors and other components in a handheld device and their interactions according to one embodiment.

[0038] Fig.12 A process of measuring ion concentration by a sensor of a device according to one embodiment is depicted.

[0039] Fig.13 A process for transmitting data or generating an alert between a device and a server or display according to one embodiment is depicted. DETAILED DESCRIPTION

[0040] The following detailed description contains many details for the purpose of illustration, but one of ordinary skill in the art will appreciate that many changes and modifications can be made to the following details and are included herein.

[0041] Therefore, the following embodiments are set forth without loss of any generality and without imposing limitations on any claims set forth. It should also be understood that the terminology used herein is for the purpose of describing specific embodiments only and is not limiting. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the present disclosure belongs.

[0042] As used in this written description, the singular forms "a," "an," and "the" include explicit support for plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a sensor" includes a plurality of such sensors.

[0043] In the present disclosure, "include", "comprising", "with", "having", etc. may have the meanings assigned to them in the U.S. patent law, and may mean "including", "comprising", etc., and are generally interpreted as open terms. The term "consisting of" or "consisting of" is a closed term, which only includes the components, structures, steps, etc. that are explicitly listed with such terms, and the content that complies with the U.S. patent law. "Substantially consisting of" or "substantially consisting of" have the meanings generally assigned to them in the U.S. patent law. In particular, these terms are generally closed terms, but allow the inclusion of additional items, materials, components, steps or elements that do not significantly affect the basic and novel characteristics or functions of the relevant items. For example, trace elements are present in the composition but do not affect the properties or characteristics of the composition, and if they are present under the language of "substantially consisting of", even if they are not explicitly listed in the list of items after such terms, this is also allowed. When open-ended terms such as "include" or "comprising" are used in this specification, it should be understood that the "substantially consisting of" and "consisting of" language are also directly supported, as explicitly stated, and vice versa.

[0044] The terms "left", "right", "front", "rear", "top", "bottom", "above", "below", etc., in the specification and claims, if any, are used for descriptive purposes and are not necessarily used to describe permanent relative positions. It should be understood that the terms so used are interchangeable under appropriate circumstances, such that the embodiments described herein are, for example, capable of operation in other orientations than those shown or otherwise described herein. As used herein, the phrases "in one embodiment" or "in one aspect" do not necessarily all refer to the same embodiment or aspect.

[0045] As used herein, when used in conjunction with the description of an apparatus or method, "enhancement", "improvement", "performance enhancement", "upgrade" and the like refer to an apparatus or method that provides significantly better form or function than previously known apparatus or methods. This applies to both the form and function of individual components of the apparatus or method and to the apparatus or method as a whole.

[0046] Objects or structures described herein as being "adjacent" to each other may be in physical contact with each other, in close proximity to each other, or in the same general area or region as each other, depending on the context.

[0047] As used herein, the term "about" is used to provide flexibility for numerical range endpoints by providing that a given value may be "slightly above" or "slightly below" the endpoint. However, it should be understood that even when the term "about" is used in conjunction with a specific numerical value in this specification, the exact numerical value listed in addition to the "about" term is also supported.

[0048] References throughout this specification to "an example" mean that a particular feature, structure, or characteristic described in conjunction with the example is included in at least one embodiment. Therefore, the phrase "in an example" appearing in various places throughout this specification does not necessarily refer to the same embodiment.

[0049] The embodiments and all functional operations described in this specification may be implemented in digital electronic circuits, or in computer software, firmware or hardware, including the structures disclosed in this specification and their structural equivalents, or in a combination of one or more of them. The embodiments may be implemented as one or more computer program products, i.e., one or more computer program instruction modules, encoded on a computer-readable medium, for execution by a data processing device or for controlling the operation of a data processing device. The computer-readable medium may be a machine-readable storage device, a machine-readable storage substrate, a memory device, a material composition that affects a machine-readable propagation signal, or a combination of one or more of them. The term "computing system" encompasses all devices, apparatuses and machines for processing data, including, for example, a programmable processor, a computer or multiple processors or computers. In addition to hardware, a device may also include code that creates an execution environment for the computer program in question, for example, code that constitutes processor firmware, a protocol stack, a database management system, an operating system, or a combination of one or more of them. A propagated signal is an artificially generated signal, such as a machine-generated electrical, optical or electromagnetic signal, that is generated to encode information for transmission to a suitable receiver device.

[0050] The actual dedicated control hardware or software code used to implement these systems and / or methods is not limited to these embodiments. Therefore, the operation and behavior of the systems and / or methods are described herein without reference to specific software code - it should be understood that software and hardware can be designed to implement the systems and / or methods based on the description herein.

[0051] A computer program (also referred to as a program, software, software application, script, or code) may be written in any suitable form of a programming language, including compiled or interpreted languages, and it may be deployed in any suitable form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A computer program does not necessarily correspond to a file in a file system. A program may be stored in a portion of a file containing other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files storing one or more modules, subroutines, or portions of code). A computer program may be deployed to execute on a single computer or on multiple computers located at a single site or distributed across multiple sites and interconnected by a communications network.

[0052] The processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform functions by operating on input data and generating output. The processes and logic flows can also be performed by special purpose logic circuits, and the device can also be implemented as a special purpose logic circuit, such as but not limited to, PLC (programmable logic controller), FPGA (field programmable gate array), ASIC (application specific integrated circuit), program specific standard product (ASSP), system on chip (SOC), complex programmable logic device (CPLD), etc.

[0053] Processors suitable for executing computer programs include, for example, general-purpose and special-purpose microprocessors, and any one or more processors of any suitable kind of digital computer. In general, the processor will receive instructions and data from a read-only memory or a random access memory or both. The elements of a computer may include a processor for executing instructions and one or more memory devices for storing instructions and data. In general, the computer will also include or be operably coupled to receive data from or transmit data to or both of one or more mass storage devices (e.g., magnetic disks, magneto-optical disks, or optical disks) for storing data. However, the computer need not have such devices. In addition, the computer may be embedded in another device, such as a mobile phone, a personal digital assistant (PDA), a mobile audio player, a global positioning system (GPS) receiver, and the like. Computer-readable media suitable for storing computer program instructions and data include all forms of non-volatile memory, media, and storage devices, including, for example, semiconductor storage devices, such as EPROM, EEPROM, and flash memory devices; magnetic disks, such as internal hard disks or removable disks; magneto-optical disks; CD ROM and DVD-ROM disks. The processor and memory may be supplemented by or combined in a dedicated logic circuit.

[0054] To provide interaction with a user, an embodiment may be implemented on a computer having a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to the user and a keyboard and a pointing device through which the user can provide input to the computer, such as a mouse or trackball. Other types of devices may also be used to provide interaction with the user; for example, the feedback provided to the user may be any suitable form of sensory feedback, such as visual feedback, auditory feedback, or tactile feedback; input from the user may be received in any suitable form, including sound, voice, or tactile input.

[0055] An embodiment may be implemented in a computing system that includes a back-end component (e.g., as a data server) or includes an intermediate component (e.g., an application server) or includes a front-end component (e.g., a client, a computer with a graphical user interface or a web browser through which a user can interact with the embodiment) or any suitable combination of one or more such back-end, intermediate or front-end components. The components of the system may be interconnected by any suitable digital data communication form or medium (e.g., a communication network). Examples of communication networks include local area networks ("LANs") and wide area networks ("WANs"), such as the Internet.

[0056] A computing system may include clients and servers. Clients and servers are generally remote from each other and generally interact through a communication network. The relationship of client and server arises through computer programs running on respective computers and having a client-server relationship to each other.

[0057] Embodiments of the present invention may include or utilize a special or general purpose computer including computer hardware. Embodiments within the scope of the present invention also include physical and other computer readable media for carrying or storing computer executable instructions and / or data structures. Such computer readable media may be any available media that can be accessed by a general or special purpose computer system. Computer readable media that store computer executable instructions are physical storage media. Computer readable media that carry computer executable instructions are transmission media. Therefore, embodiments of the present invention may include, by way of example and not limitation, at least two distinct computer readable media: physical computer readable storage media and transmission computer readable media.

[0058] Physical computer-readable storage media include RAM, ROM, EEPROM, CD-ROM or other optical disk storage (such as CD, DVD, etc.), magnetic disk storage or other magnetic storage devices, or any other device that can be used to store the desired program code in the form of computer-executable instructions or data structures and can be accessed by a general-purpose or special-purpose computer.

[0059] A "network" is defined as one or more data links capable of transmitting electronic data between computer systems and / or modules and / or other electronic devices. When information is transmitted or provided to a computer via a network (e.g., a 5G network) or other communication connection (hardwired, wireless, or a combination of hardwired or wireless), the computer will appropriately view the connection as a transmission medium. Transmission media may include networks and / or data links that can be used to carry data or desired program code devices in the form of computer-executable instructions or data structures and can be accessed by general or special-purpose computers. Combinations of the above are also included within the scope of computer-readable media.

[0060] Furthermore, upon reaching various computer system components, program code devices in the form of computer executable instructions or data structures may be automatically transferred from a transmission computer readable medium to a physical computer readable storage medium (or vice versa). For example, computer executable instructions or data structures received over a network or data link may be cached in RAM within a network interface module (e.g., a "NIC") and then ultimately transferred to computer system RAM and / or to a computer readable physical storage medium in a non-volatile computer system. Thus, a computer readable physical storage medium may be included in a computer system component that also (or even primarily) utilizes a transmission medium.

[0061] Computer executable instructions include, for example, instructions and data that cause a general purpose computer, a special purpose computer, or a special purpose processing device to perform a specific function or group of functions. For example, computer executable instructions can be binary, intermediate format instructions (such as assembly language), or even source code. Although the subject matter has been described in language specific to structural features and / or methodological behavior, it should be understood that the subject matter defined in the appended claims is not necessarily limited to the features or behaviors described above. Instead, the described features and actions are disclosed in the form of examples implementing the claims.

[0062] Although this specification contains many details, these should not be interpreted as limitations on the scope of the present disclosure or what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features described in the context of a single embodiment in this specification may also be implemented in a single embodiment combination. On the contrary, the various features described in the context of a single embodiment may also be implemented in multiple embodiments individually or in any suitable sub-combination. In addition, although features may be described in certain combinations as working in certain combinations and even initially claimed as such, in some cases, one or more features from the claimed combination may be removed from the combination, and the claimed combination may be directed to a sub-combination or a variant of the sub-combination.

[0063] Similarly, although operations are depicted in a particular order in the accompanying drawings, this should not be understood as requiring that the operations be performed in the particular order shown or in sequence, or that all illustrated operations be performed to achieve the desired results. In some cases, multitasking and parallel processing may be advantageous. In addition, the separation of various system components in the above-described embodiments should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products.

[0064] Even though particular combinations of features are recited in the claims and / or disclosed in the specification, these combinations are not intended to limit the disclosure of potential implementations. Other implementations are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve the desired results. In fact, many of these features can be combined in ways not specifically recited in the claims and / or disclosed in the specification. Although each dependent claim listed below may be directly dependent on one claim, the disclosure of possible implementations includes each dependent claim in combination with every other claim in the claim set.

[0065] In addition, these methods can be implemented by a computer system including one or more processors and a computer-readable medium such as a computer memory. In particular, the computer memory can store computer-executable instructions that, when executed by one or more processors, result in the execution of various functions, such as the actions listed in the embodiments.

[0066] As used herein, the term "electrode" is used to refer to an electrical conductor used to make contact with a non-metallic portion of an electrical circuit.

[0067] As used herein, the term "control and measurement circuit" is used to indicate that the control and measurement circuit is a component of the entire system including a microprocessor and a sensor circuit connected to the microprocessor.

[0068] As used herein, the term "temperature sensor" is used to refer to a device that provides a temperature measurement via an electrical signal, typically a thermocouple, RTD (resistance temperature detector), or thermistor.

[0069] As used herein, the term "radio circuitry" is used to refer to circuitry that provides wireless transmission and includes a microprocessor for managing the input and output of the system. The radio circuitry includes an antenna.

[0070] As used herein, the term "antenna" is used to refer to the interface between radio waves propagating in space and electric currents moving in metallic conductors, used in conjunction with a transmitter or receiver.

[0071] As used herein, the term "substrate" is used to refer to a material that supports an ion monitoring device. In one embodiment, the substrate is flexible to adapt to the contours of a surface. An example of a flexible substrate is polyethylene terephthalate glycol (PETG).

[0072] As used herein, the term "energy source" is used to refer to a source from which useful energy can be extracted or recovered, either directly or through a conversion or transformation process. Examples include batteries, which are one form of energy used in one embodiment of the present invention.

[0073] As used herein, the term "smart hub" is used to refer to a smartphone, smart watch, or any other personal mobile device that can wirelessly connect to a data transmitter.

[0074] As used herein, the term "body fluid" is used to refer to.

[0075] As used herein, the term "App" is used to refer to application software for a mobile device or a computer.

[0076] As used herein, the term "real time" or "real-time" refers to a system in which input data is processed within milliseconds so that the data can be used in an almost immediate output or feedback process to its source. Graphics or feedback are used to observe objects in real time and display results, such as: indoor air conditioning that displays room temperature in real time, power systems that measure and control power quality parameters such as frequency, peak voltage, power factor, etc. in real time.

[0077] The following provides a preliminary overview of the technical embodiments, and then describes specific technical embodiments in more detail. This preliminary overview is intended to help readers understand the technology more quickly, but is not intended to identify key or basic technical features, nor is it intended to limit the scope of the claimed subject matter.

[0078] The embodiments herein and their various features and advantageous details are explained more fully hereinafter with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description.

[0079] The advantages provided by the present invention include but are not limited to the following.

[0080] By adding components such as temperature sensors, the system is also able to perform multi-parameter measurements. Cross-analysis of multiple parameters can also allow the device to provide the user's accurate dehydration level or other parameters such as electrolyte-related diseases.

[0081] The system, with the addition of components such as temperature sensors, is also able to measure the electrolytes of any liquid. This can also allow the study and collection of electrolyte level data in other living and non-living things, plants or liquids.

[0082] The system is non-intrusive and requires little or no knowledge from the user to operate.

[0083] The system can communicate wirelessly with a personal portable hub used as a display interface via a wireless connection such as Bluetooth, WiFi, RFID, BLE, radio frequency signals, GSM signals, etc.

[0084] The proposed system can non-invasively assess a person's hydration level in real time by utilizing galvanically measured sweat resistance and can be extended to other applications such as glucose levels.

[0085] The data measured by the system can advantageously be collected wirelessly by a smart hub (smartphone, smartwatch, or any other personal mobile device) that can perform more complex signal processing and serve as an interactive display interface with the end user.

[0086] The present invention can be better understood by the following examples. It is worth noting that these examples are only used to illustrate certain forms of application of the present invention, which is broader and more general for any application related to non-invasive measurement of the ion content of biological fluids and their volume. In one embodiment, the ions measured are electrolytes and the biological fluid is sweat. Dehydration is directly related to the ion concentration in sweat.

[0087] Figure 1a Pulses that can be used in embodiments of the present invention are depicted. A pulse waveform is formed by a rapid or sudden transient change from a baseline value to a higher or lower level value, and then returning to the same baseline value after a certain period of time. Such a signal may be referred to as a pulse signal. A pulse signal is a unidirectional non-sinusoidal signal, similar to a square wave signal, but it is not as symmetrical as a square wave. A series of continuous pulse signals is referred to as a pulse train. A pulse train represents a transition from a baseline level to a sudden high level and a sudden low level, which can be understood as ON / OFF, respectively. The measurement from any point in one cycle to the same point in the next cycle is called a waveform cycle.

[0088] Figure 1b A circuit for generating pulses that can be used in embodiments of the present invention is depicted. The most widely used integrated circuit for this purpose is the 555 timer. This timer can be connected to act as an oscillator (astable multivibrator), such as Figure 1b The on-time t of the generated pulse waveform is ON Depends on the resistance Rl, given by formula (1):

[0089] t ON =1169.0C 1 R 1 Formula (1)

[0090] During the on-time, diode D2 is forward biased, so resistor R2 is short-circuited. On the other hand, during the off-time t OFF It depends only on the resistor R2 and is given by formula (2):

[0091] t OFF =0.69.0C 1 R 2 Formula (2)

[0092] During the off period, diode D1 is forward biased, so resistor R1 is short-circuited. The period of the generated pulse waveform is shown in formula (3):

[0093] T=t ON +t OFF Formula (3)

[0094] In order to change the pulse width of the output signal of the timer, the resistor R1 can be varied by connecting it as a potentiometer.

[0095] Figure 2a and Figure 2b The top view and side view of electrodes that can be used in embodiments of the present invention are depicted respectively. Representative examples of the present invention are shown in the accompanying drawings. Figure 2a Referring to a two-dimensional planar circuit 202 for use in the present invention according to one embodiment, it includes an electrode 204 and an electrode 206 to form an electrode pair. In addition, a lead 208 is shown, where the circuit will be connected to the electrode through a zero-force connector or a sliding connector. Figure 2b When viewed from the side view shown in , the two-dimensional planar structure has three layers: the first or top layer 202 is made of approximately 3 mil PET and is white, with the electrodes printed on it by screen printing electrode (SPE) ink; the next layer (second layer) 210 is made of approximately 3 mil thick acrylic glue; the bottom or third layer 212 is a glue liner that can be peeled off before use. The first layer including the electrodes, also referred to as the electrode layer 202, is used to be placed on the skin of the person or organism wearing the device and to come into contact with the sweat of the person or organism when in use. The third layer 212 can be torn off and easily attached to any surface, such as a watch strap. All three layers 202, 210 and 212 are collectively referred to as electrodes. The thin and flexible electrode structure enables it to fit the contours of the surface to which the electrode is attached or glued.

[0096] The black portions or electrodes shown as 204 and 206 represent the area of ​​the electrodes and the gap between electrodes 204 and 206 represents the distance between the electrodes. The voltage drop due to electrolyte sensing is a function of the electrode area and the distance between the electrodes. The device is initially calibrated to sense electrolyte based on its electrode area and the distance between the electrodes. The area and the distance between the electrodes are limited. In the current embodiment of the invention, the area can be 10 mm 2 Up to 75mm 2 Changes between.

[0097] Figure 3 A wearable hydration monitoring device with electrodes affixed to a band of a wearable device is depicted according to one embodiment. The figure shows a device 302 (which is the same as 202 of FIG. 2 ) as part of a wearable or portable device 304. According to one embodiment, the device is attached to or made part of band 304. The device may also include an indicator. The indicator may be anything that communicates with the wearer, including but not limited to visual indicators that convey information to the wearer, such as colors, numbers, noises, vibrations, etc.

[0098] Regarding the circuit for pulse signal, pulse width modulated pulse signal of maximum 200 Hz, similar to integrated circuit (IC) and timer IC, electromechanical switch or relay. Transistor or any other switching mechanism to generate pulse signal of frequency specified in the patent.

[0099] Figure 4 A wearable hydration monitoring device is depicted secured to a band of a wearable device having a display, according to one embodiment. Figure 4 A wearable device is shown, in this embodiment a watch, which includes an electrolyte measurement device or sensor 406, which includes electrodes 402 (also 302, 202) and a microcontroller circuit 403, which is positioned so that the electrodes can be exposed to body fluids, such as sweat. In some embodiments, the microcontroller circuit 403 can be part of the watch case 404, in which case the electrodes 402 are only exposed on the wearable watch band. The display of the device can be used to display graphics, data, etc. from the device or sensor 406 via Bluetooth or any near field communication method.

[0100] Figure 5 A band according to one embodiment is depicted, having a hydration monitoring device attached thereto so that the electrodes of the device are in contact with the skin of the wearer of the band. Device 503 (also 403) is shown according to an embodiment, wherein electrodes 502 (also 402, 302, 202) are attached to a band 504, which can be worn by a person (e.g., an athlete) during an activity. In one embodiment, it is envisioned that all circuits are placed within a wearable device such as a watch. The circuits and electrodes can communicate via Bluetooth. In another embodiment, a user can use a band with all sensors and circuits that can be connected to any wearable device, such as a watch. This band equipped with an embedded device can be sold as a standalone product and can be used in combination with any watch of the user's choice. Figure 3 , Figure 4 and Figure 5 are different embodiments of sensors and devices. Figure 3 Only the electrodes are shown. Figure 4 shows electrodes with circuitry forming a sensor in a watch, Figure 4 Electrodes with circuitry are shown forming sensors in a watch band. All of these examples show that the electrodes and circuitry may or may not be in contact with each other but still form a sensor. When both the sensor and the electrodes are present in a device but not necessarily in juxtaposition or in physical contact with each other, it is referred to as a sensor.

[0101] Figure 6Shown is a circuit diagram of a sensor for an embodiment of the present invention, wherein a microcontroller 606 includes an energy source (e.g., a battery) and sends a signal to an electrode 602, as shown in Fig. 1a and Fig. 1b. Voltage is applied to a circuit that can sense ion concentration changes. The ion sensing circuit comprises: an electrode pair 602, a first resistor R1 (shown as 610), a capacitor C (shown as 612 and electrically connected in series with a resistor R1), a second resistor R2 (shown as 614 and electrically connected in parallel with the electrode pair shown as 602). A first node 615 sets up a first electrical connection between a capacitor and a second resistor and a pair of electrodes in parallel, and a second node 616 sets up a first electrical connection between a capacitor and a second resistor and a pair of electrodes in parallel. Reading node 617 is electrically connected to the first node and can be used to send all data and readings to a configured processor or memory or display device.

[0102] Figure 7a and Figure 7b A bottom view and a top view of a hydration monitoring device or sensor according to one embodiment are depicted, respectively, wherein the device has a flat horizontal structure. As shown, the device or sensor 706 includes an accessory 708 that can be used to attach the device or sensor 706 to other portable or wearable devices. The device or sensor 706 has electrodes 702, a microcircuit or circuit 710, and a battery holder 709 in its housing 704.

[0103] In one embodiment, the device can be part of a wearable device, it can be embedded in a neck collar, it can be embedded in a sock or any piece of clothing.

[0104] Figure 8 Depicted is the interior of a hydration monitoring device showing electronics and circuitry connected to electrodes according to one embodiment. The electronics and circuitry are enclosed in a housing and connected to the electrodes.

[0105] Figure 9a depicts a standalone hydration monitoring device with an integrated display according to one embodiment, Figure 9b Depicted is the back side of a standalone hydration monitoring device with an integrated display, according to one embodiment. The hydration monitoring device or sensor has electrodes toward the back side (shown as 904) and an integrated display 902 on the other side or front side that can be used to monitor parameters when the device is used without any additional wearable device (e.g., a watch). According to one embodiment, the device can be secured to a sleeve so that the electrodes 906 present on one side 904 are exposed and in contact with the user's skin. The device or sensor displays a graph of monitored hydration levels during an example workout, such as Figure 9aAs shown. In this embodiment, the device can provide a real-time display of monitored or calculated parameters (including hydration parameters) without any additional equipment for visualization or data reading. Even without an integrated display, the device is still independent and able to read and store parameters, except that an additional display needs to be connected to enable visualization of the data. The data is stored in the processor memory and can be accessed and visualized by transferring the data to a nearby device with a display.

[0106] Although electrolyte monitoring devices can be attached to the body or worn as wearable devices, the detection devices can also be used with any body fluid or other fluid containing electrolytes, such as urine or even vapors from plants.

[0107] The device may also include other components, including but not limited to temperature sensors, radio circuits, antennas, flexible substrates, energy sources. The device may also be part of a system. The device may also be part of a system that may include remote sensors and smart hubs.

[0108] Conductivity is a measure of ions such as electrolytes in a solution (e.g. sweat). Conductivity is used to monitor electrolytes in body fluids. Conductivity is the ability of a solution to conduct an electric current. Conductivity allows for the measurement of electrolytes in sweat and can be used to determine the user's hydration status. Conductivity is related to resistance in the following formula (4):

[0109]

[0110] When the device is a wearable device or is used with a wearable device to monitor hydration, the device can be safely placed on the subject's skin. The current is small, approximately 0-0.01 amps, allowing the device to contact the skin without causing harm or discomfort. The user's body, such as skin and body hair, may affect the resistance. The resistance of the user's body may vary depending on the contact point and the condition of the skin. The skin can be wet or dry. The skin resistance may vary from approximately 1000 ohms for wet skin to over 500,000 ohms for dry skin. The device according to the present invention uses direct current, and in particular uses a direct current pulse system.

[0111] An example of the device claimed in the present invention is The ion sensing circuit 202 (also 302, 402, 702) reads the electrolyte conductivity of sweat in real time by using a circuit including resistors 610, 614, at least one capacitor 612 and a voltage source of a microcontroller or microprocessor 606. Sweat is composed of conductive ions, and by using an ion sensing device including the ion sensing circuit 202 (also 302, 402, 702), a voltage difference between at least two electrodes can be determined under pulsating direct current. Using artificial sweat of different concentrations and measuring the voltage drop to produce a controlled correlation, a relationship between the voltage difference and the electrolyte concentration in the sweat is established.

[0112] Fig.10 Depicted is a graph of data collected to illustrate the Nil Per Os (NPO) test at varying water intakes during exercise. Fig.10 is data collected illustrating a Nil Per Os (NPO) or No Drink Fasting Test with varying water intake during exercise. Data was collected via a Nil Per Os (NPO) or No Drink Fasting Test. The user or subject did not drink or eat anything for at least 8 hours prior to the test.

[0113] According to one embodiment, the graph displays real-time data, wherein the x-axis represents time in a hours:minutes:seconds format and the y-axis represents data measurements as the number of bits or binary digits, representing voltage. During the first 10 minutes of the workout (i.e., from 8:48:29 to 8:58:29), the user's body begins to sweat and the hydration level decreases as shown in 1008. The decrease in hydration level is related to parameters such as the height, weight, age of the person, the activity the person is engaged in, and the environmental conditions in which the person is engaged in such activities. Each point represents a data measurement as the number of bits or binary digits, representing voltage. The voltage can be converted into a salt, electrolyte, or ion concentration value. As can be seen in Fig.10 As observed on the graph of , there were two water intakes during the subject's workout, represented by cross marks, as shown at 1002, and the time area where the events occurred has been circled. After these two water intakes, it can be observed that the user's hydration level increases after 3 minutes, i.e., the segment represented as 1004. The algorithm that generated the graph may have an internal threshold, for example, a line 1006 is drawn between 600 and 500, at which the device algorithm may remind or suggest the user to drink water. In another embodiment, another threshold may be set, where the hydration level is below 300, and then the user is reminded to drink water and possibly stop the activity.

[0114] This data is used to create an algorithm to establish a strong correlation between the sweat and hydration status of the organism. The algorithm is introduced into a microcontroller to process the data received from the ion sensing circuit along with other sensory data such as heartbeat or using data from other types of sensors such as temperature, acetone sensor, gas sensor, atmospheric pressure sensor, GPS, accelerometer, etc.

[0115] The direct current (DC) current is pulsed at a rate that prevents ions from accumulating on the electrodes. Many factors are considered to optimize the pulse frequency. In one embodiment of the present invention, the DC current is pulsed at a maximum frequency of 200 Hz, preferably operating at 100 Hz. The temperature of the user or subject's skin may also indicate changes in the user.

[0116] In one embodiment of the present invention, a temperature sensor is included in the ion sensing device to provide data related to hydration. In another embodiment of the present invention, the microprocessor transmits the ion concentration status with red, yellow or green light depending on the hydration status of the user. In one embodiment, the device can be insulated to protect it from dust and water. Moreover, the user can easily clean the device or replace the battery. All the data collected by the microprocessor can be sent to a smartphone or computer with software or a dedicated application via Bluetooth. An application named hDrop has been developed for collecting all the data from the device and analyzing the data. Similar third-party applications compatible with the device can be developed and used in one embodiment. The data is further transmitted and uploaded to a database and the user receives his or her workout chart from the real-time data.

[0117] Another embodiment of the present invention is a device small enough to be mounted on a watch band or sports sleeve between other clothing items. The device is compatible with any wireless receiver, including wireless receivers, through wireless technology such as current Bluetooth connections or other well-known wireless connections. Watch, watch, Wearable devices, etc.

[0118] The method utilizes a rectangular circular design of electrodes and resistance measurement by a DC pulse signal. The conductive material of the thin layer electrodes depicted as 204 and 206 in Figure 2 are designed concentrically and placed on one side of a flexible substrate in contact with the skin, which has an adhesive on the other side.

[0119] The circuit of the device is as Figure 6As shown, including a DC power supply electrically connected to the sensing circuit. The sensing circuit includes a microcontroller 606, a first resistor R1 shown as 610 electrically connected to the microcontroller, a capacitor C shown as 612 or multiple capacitors in series with the first resistor R1 or multiple resistors shown as 610, and a second resistor R2 614 or multiple resistors placed in parallel with more than two electrodes and connected in series with the capacitor or the first capacitor (in the case of multiple capacitors). After the last parallel connection between the last resistor or multiple resistors and the electrode 602, the circuit is connected to the microcontroller. The device may include more sensors, such as temperature sensors and heart sensors, and the readings of these sensors. The signal is processed in the microprocessor. The temperature sensor is contained on a flexible substrate for monitoring the core body and / or skin temperature of the object, and temperature correction of the resistance measurement from the circuit. The energy source can be remote or local, depending on whether the ion sensing device is portable or fixed and how the energy is transmitted to the device. In an embodiment where the device is local, the energy source can be composed of a button lithium battery, a rechargeable battery, a renewable power source such as a solar cell, or other types of energy collectors.

[0120] The device is based on the principle of variable frequency electrode measurement for resistance measurement. By applying pulsed direct current, the device can detect the electrolyte composition of the liquid, with a minimum time delay of 10ms between each pulse. In order to detect different hydration states of a person, the number of bits or binary digits can be converted into the actual percentage of electrolyte concentration in the liquid. By knowing the electrolyte concentration of the liquid (in this case, sweat), the literature research value of the electrolyte percentage in sweat can be used to determine the hydration state. The current applied between the external electrodes is direct current (DC), which allows all information about the resistance equivalent circuit to be extracted. In addition, the ion sensing device and the method make it easier than any other device to contact the user's skin and obtain readings through pulsating direct current in a limited minimum time by using two-dimensional planar electrodes. The design of the device allows sweat to continuously flow out of the measuring range of the electrode, so that new sweat will be continuously analyzed as soon as it is discharged from the body. In a preferred embodiment, the electrodes are designed to be easy to clean and reused for a long time. The ion sensing device can also be used to determine and monitor the user's glucose level. A relationship between glucose and electrolyte concentration can be established to monitor glucose levels. In another embodiment of the present invention, a non-invasive blood glucose meter is allowed to be established.

[0121] In one embodiment, the hydration monitoring system can be applied directly on the surface of a person's skin and / or inside any type of wearable device, such as a watch or clothing. The hydration monitoring system can be fixed on any type of flexible substrate on which thin conductive electrodes can be fixed or processed. Alternatively, the device can be in contact with body fluids in any manner, including but not limited to manual application.

[0122] In another embodiment shown in Figure 9, the system is enclosed in a protective housing with the sensing circuit positioned to properly contact the skin. The system is intended to communicate wirelessly with a smart hub that serves as a display interface and provides complete hydration information as well as some bio-parameters that characterize body fluids and skin characteristics. It can therefore be used in other categories of applications such as health, sports, and fitness that utilize these parameters.

[0123] The electrodes are configured to detect current and / or voltage and determine a resistance difference between the electrodes when exposed to a fluid.

[0124] The microcontroller acts as a data pump to publish data from the sensors. All of this data is available through a data acquisition hub, such as a personal smart hub, which includes a nearby mobile device or computer.

[0125] The voltage or current source is controlled and pulsed. The voltage is generated on a microcontroller or host computer chip. The voltage is a low current of less than 0.01 amps, allowing the device to operate directly on the skin without causing any harm to the user. This provides a safe environment for the user. The voltage consists of a DC pulse current. The voltage passes through the ion sensing circuit until it reaches the electrode. When the voltage reaches the electrode, the voltage passes through the liquid or semi-liquid surface in contact with the electrode and propagates in it, generating a certain voltage drop. The voltage drop is then converted to a hydration state by an algorithm. By determining the peak voltage and equivalent resistance flowing through the circuit, the voltage drop before the resistor or multiple resistors set in parallel with the electrode can be read at the reading node.

[0126] One application of the device is to determine the electrolyte concentration on human skin among other applications. To zero the skin resistance, the device can be applied on dry skin to determine the resistance value of the skin. The user can be asked a few questions through the App or questionnaire to determine the user's habits and body specifications to optimize the device. The user will go through a calibration period. They will record some exercises (sedentary and active exercises) to determine the baseline for this particular user. Machine learning and / or deep neural networks are then used to generate the user's baseline. Zero the skin factor and take into account the following factors: activity type, exercise intensity, exercise duration, temperature, relative humidity, heat radiation / exposure, internal / external air flow, clothing or wearing, water intake before exercise, ability to replenish fluids, electrolyte intake, heat adaptation level, body composition, age, fitness level, body temperature, heart rate, blood oxygen level, genetics, etc., and then use some or all of these parameters to create an algorithm to determine the user's hydration status.

[0127] Studies have shown that as the degree of dehydration increases during exercise, various physiological functions are gradually affected: heart rate and core temperature increase over time, while blood volume, stroke volume, cardiac output and skin blood flow all decrease. For athletes, dehydration is a result of the body's thermal regulation through sweating, which is a mixture of water and minerals. During the most intensive efforts, the amount of water lost by the human body can exceed 3.5 liters. If this loss of water and minerals is not compensated, dehydration can lead to hypovolemia (drop in blood pressure), hypokalemia (paresis of the limbs), hyponatremia (respiratory disorders, disorientation) and hypernatremia (excessive sodium or electrolytes in the blood).

[0128] These are extreme cases, but the consequences of dehydration are certainly suboptimal. Glucose is the body’s gas. Glycogen is made up of three water molecules. So without water, athletes cannot use their glucose reserves. It is estimated that a 1 to 2 percent water loss can result in a 10 percent decrease in performance.

[0129] Other populations relevant to the present invention are first responders and vulnerable populations, such as the elderly and infants.

[0130] Fig.11 Sensors and other components in a handheld device according to one embodiment and their interactions are depicted. It includes a sensor module 1102 and a handheld device 1120. The sensor module 1102 also includes electrodes 1104, ion sensor electronics 1106, and also includes other sensors such as temperature, heart rate sensor, etc. It includes a microcontroller 1110, a storage module 1112, and a communication module 1114 to transmit data to the handheld device 1112. The handheld device includes a processor 1122, a memory 1124, a communication module 1126, an input unit 1128, a display unit 1130, and a database 1132. At 1152, it can be connected with an application to calculate ion levels, sweat rate, hydration status, fluid intake, etc. The application can be further programmed to create charts, alarms, and for storing and accessing data in real time or post real time at 1154.

[0131] Fig.12 Depicted is a process of measuring ion concentration by a sensor of a device according to one embodiment. The sensor of the device measures ion concentration 1202, stores data 1204, and processes the data 1206. The data is further sent to a display to generate a graph 1208. The device can be further configured to transmit the data to a database or handheld device 1210.

[0132] Fig.13Depicted is the process of transmitting data or generating an alert between a device and a server or display according to one embodiment. The sensor uses its communication module to send data to a database or a wearable or handheld device with a display. The wearable device receives the data from the device 1302, processes it 1304, stores the data 1306, and can display a graph or issue an alert 1308 based on an application or algorithm configured in the wearable or handheld device.

[0133] Example

[0134] The following examples relate to further embodiments.

[0135] experiment

[0136] Experiment 1: Test the device using human sweat drops to ensure the accuracy of the conductivity sensor.

[0137] Specific technical requirements for verification

[0138] The device detects changes in electrolyte concentrations in 0.5mL of sweat (ideally 50μL).

[0139] The device reports electrolyte concentrations above 40mmol / L as dehydration, below 30mmol / L as healthy, and in between as slightly dehydrated within 10% of the expected value.

[0140] Equipment: dropper (capable of measuring 50 μL accurately), hydration monitoring device according to the invention (fully assembled), dummy arm or real arm, container containing 20 mL of NaCl at a concentration of 30 mmol / L, container containing 20 mL of NaCl at a concentration of 40 mmol / L.

[0141] Environment: Testing was performed in an engineering laboratory.

[0142] Test Method

[0143] 1. Use a dropper to take 50 μL of 30 mmol / L NaCl solution.

[0144] 2. Place NaCl solution on the subject's finger skin and apply it to simulate sweating characteristics.

[0145] 3. Place the ion sensing device on top of the mixture on the finger to simulate contact with the skin and completely cover the ion sensing circuit that acts as a sensor.

[0146] 4. Record the average conductivity at 1 minute intervals.

[0147] 5. Repeat steps 1-4 using 40 mmol / L NaCl concentration.

[0148] result

[0149] Place your finger on top of the solution with equal force to compare with the previous test and keep the sensor completely covered.

[0150] Table 1. Conductivity readings of hDrop

[0151]

[0152] The process of converting the digital number represented by the number of bits into a resistance value is accomplished by placing a known resistance value at the end of the electrode and comparing the resistance value with the number of bits recorded by the microcontroller. Thus, a curve as shown in Figure 15 can be drawn, which illustrates the relationship between the digital value and the resistance value according to an embodiment.

[0153] The original values ​​were taken in a different environment than the above readings. The environment was at a different temperature and at a different relative humidity. The temperature affected the solution resistance by ±2% respectively. The main reason for the difference in results is the effect of temperature on conductivity.

[0154] Ion sensing circuit or sensor

[0155] The ion sensing device comprises electrodes, which in one embodiment are two-dimensional flat conductive printed electrodes, and filtering and ion sensing circuitry.

[0156] Two-dimensional flat conductive printed electrodes

[0157] Using two-dimensional flat conductive printed electrodes achieves three main functions. The entire sensor is in contact with the skin and can be easily customized to a specific geometry for better results. The distance between electrodes is fixed on this type of electrode, which makes the measurement more stable. This type of electrode is easy to clean and provides a long life for the device. The device is configured to use information about the shape, area and distance of the electrodes that affect the voltage drop to read the data of the solution or electrolyte.

[0158] Factors of electrode shape and geometry that may affect the microcontroller's analog-to-digital conversion and solution voltage drop reading include the total area of ​​the electrodes and the distance between the electrodes. If the electrode area increases, the resistance value decreases; if the distance between the electrodes increases, the resistance value increases.

[0159] Filtering and sensing circuits

[0160] Figure 6The filtering and sensing circuit shown in follows the following process: The microcontroller switches on / off with a minimum time of 5ms, sending DC current pulses at a maximum frequency of 200Hz. This frequency allows the electrons of the solution to reorganize into the initial salt structure before a reading is obtained. This effect is called polarization and can be avoided by applying a direct current (DC) current pulse. If the frequency pulse applied is greater than 100Hz, the solution will begin to polarize. The hydration monitoring device does not require an AC converter. The microcontroller applies a DC pulse and generates an electric field. The electric field causes ions to move from one electrode to another, thereby generating an ionic current. The device uses Ohm's law to calculate the resistance value of the fluid sample. This resistance value can be converted to resistivity through the relationship between the area and length of the flat electrode in contact with the skin. The resistivity value can then be converted to conductivity and from this value to salt or electrolyte concentration. This concentration is related to the hydration status of the user or subject. By detecting changes in these electrolytes, the device can monitor the hydration level of the user wearing or using the device.

[0161] Other factors that affect the microcontroller analog-to-digital conversion and the filtering and sensing circuitry of the solution voltage drop reading are cable resistance, cable capacitance, and resistor and capacitor values.

[0162] Temperature Sensor

[0163] In another embodiment, the hydration monitoring device includes a temperature sensor. The temperature sensor should be close to the skin in order to obtain accurate readings. By using multiple temperature sensors, calibration between body temperature and ambient temperature can be accomplished. Applying a layer of insulating or waterproofing material around the temperature sensor and the internal circuitry of the device can protect the device. When this layer of insulating material is applied, the effective temperature must be recalculated in order to read an accurate result from the temperature sensor. Conductivity is affected by temperature through a linear temperature coefficient, as shown in equation (5).

[0164]

[0165] C 25 is the conductivity calculated at 25°C, C t is the raw conductivity at t°C (degrees Celsius), and α is the linear temperature coefficient. Only one temperature coefficient can be used in the range of 30°C or 40°C with sufficient accuracy, and the accuracy can be improved by calculating the coefficient specifically for the sample temperature. This temperature variable affects the measurement of conductivity, so it is necessary to add a temperature sensor in the present invention.

[0166] Microcontroller

[0167] A Bluetooth Low Energy microcontroller is used to control the sensor and pump data to the receiver hub as described above.

[0168] Data collection and analysis

[0169] The data collection of the present invention is completed by a microcontroller. The data obtained by the microcontroller is the number of millivolt reading conversion bits obtained from an analog-to-digital converter (ADC), as shown in FIG17 .

[0170] Many fluids in the human body contain electrolyte ions. These electrolyte ions (referred to herein as "electrolytes") can conduct electricity in a solution (e.g., body fluid). One embodiment of the present invention relates to an ion sensing device for measuring electrolytes in body fluids. The hydration level, as well as other parameters, can be determined from a person's electrolyte concentration.

[0171] The present invention relates to a device including a microcontroller, a sensing circuit and a voltage source. The microcontroller is fixed on a substrate and has a transmitter for transmitting ion measurements in a fluid. In one embodiment, the transmitter can send information to a receiver through a Bluetooth connection. The microcontroller is electrically connected to the ion sensing circuit also fixed on the substrate. The ion sensing circuit includes a first resistor, a second resistor, a capacitor, two electrodes, a first node, a second node and a read node. The voltage source is fixed on the substrate and electrically connected to the microcontroller.

[0172] A capacitor is connected in series with a first resistor and electrically connected to a parallel connection having a second resistor and two electrodes. The parallel connection is connected in series with the first resistor and the capacitor. A first node establishes an electrical connection between the capacitor and the parallel connection and is electrically connected to a read node. A second node establishes an electrical connection between the capacitor and the parallel connection. A microcontroller is in electrical communication with the first node and in electrical communication with the second node. The microcontroller applies voltage pulses to the electrodes at a certain frequency so that ions are not polarized at the two electrodes; and the read node is connected to a transmitter.

[0173] The device calculates the difference between the electrolyte concentrations in the fluid at different times and determines the user's hydration status. The device measurements or hydration status can be transmitted to a receiver to provide the user with information about the electrolyte composition of the fluid, including electrolyte concentration, hydration, or other information that may be useful to the user.

[0174] In another embodiment, the flexible substrate is a wearable device or is affixed to or contained within a wearable device. In another embodiment, the electrodes are two-dimensional electrodes that can be adjacent to the user's skin and in contact with a sufficient amount of sweat to allow local monitoring. The receiver can be an iPhone or iPad, such as an application developed to receive information from the device, or other similar type of receiver.

[0175] Another embodiment of the present invention is directed to a method of measuring electrolytes in body fluids using the above device. In another embodiment, the device is a wearable system that measures the hydration status of a user and notifies the user.

[0176] A system for detecting salt ion concentration comprises a device, further comprising a sensor having a carbon printed electrode disposed on a flexible substrate, the flexible substrate having an adhesive disposed on one side (back side) thereof, and an electronic circuit for generating a pulse signal stimulus and measuring salt concentration to determine the hydration level of a person or an organism, wherein the device is a wearable device.

[0177] Since the electrode is a carbon-printed electrode and is flexible, it can be made into different shapes and change the area as needed.

[0178] The data may be processed simultaneously on a microcontroller of the wearable device. The wearable device may further be configured to send a signal to a database. The database is configured to detect hydration levels and send an alert message.

[0179] These ultra-thin, flexible sensors can also be used in chemical research and experiments to count the ions and components of different chemical solutions. They are embedded in plastic casings, for example, but can also be embedded in socks or clothing.

[0180] A device having an embedded algorithm which takes measurements from a temperature sensor and a hydration sensor and with the help of the algorithm the device provides an accurate reading of the hydration level of a person or creature and further communicates the status to a trainer, parent or concerned party. When the hydration level drops below a certain point, a text message or message is sent to the monitoring trainer or trainer to immediately alert the need for water.

[0181] The present invention has three steps of sensors, combination of sensors and algorithms, and databases for monitoring and / or alarming.

[0182] A hardware device with a power input source and an embedded microcontroller, the circuit of the device includes resistors and capacitors arranged in a specific way or in a specific manner to enable the device to work. The sensor is a carbon printed electrode that can be in contact with the skin of a person or creature. Sweat contains ions and can conduct electricity, and hydration levels can be measured through sweat.

[0183] When a constant current is passed through water with ions, electrolysis occurs, and the resistance of water with ions will constantly change, making the results inaccurate. The electrolysis of the salt solution affects the signal that is being tried to be generated. Therefore, for a continuous monitoring system, the signal that is being tried to be generated (i.e. the hydration signal in this case) will be weakened over a period of time. When trying to measure the amount of salt, electrolysis is simultaneously occurring in the salt solution due to the stimulus used to produce the measurement value. Since the idea is to produce the concentration and hydration of the salt, the electrolysis caused by the salt solution must be eliminated as much as possible. The way to achieve this is to make a pulse measurement of the amount of salt. A pulse measurement is a measurement for a fraction of a second, and then the stimulus is turned off. Pulsed current generates signals that provide better and more accurate results than constant monitoring via continuous current. These pulse signals can be generated by electronic circuits or software.

[0184] Therefore, the device generates a current pulse through two electrodes, which then passes through the sweat of the person or creature and produces a constant reading of the electrolytes in the sweat. With the electrolyte information reading about the start time of sweating, it is known how long it takes to start sweating and the electrolyte levels. Whenever a person drinks water, the body reacts to it after about three minutes, and then the sensor gives a different reading.

[0185] The sensor is an ultra-thin layer, flexible, and has an adhesive on the bottom surface that can be easily attached to any device or any housing or embodiment. The device can be placed on the arm of a person or creature, and then the person or creature can start an activity, such as running or jogging. The temperature sensor can also be set to measure the temperature, as temperature and conductivity are related to each other. In order to calibrate the sensor, temperature readings are required for the entire duration or time of the activity. After the readings are measured, all this data is sent to the app via Bluetooth.

[0186] The application is compatible with or any other wearable device or watch compatible. There is also an associated application (app / App) which is compatible with Android and iOS devices connected via Bluetooth. Once the device is connected via Bluetooth, the person or creature can see the real-time status of their sweat i.e. all the readings and data. All this data is also sent to the server where a database is created. This data on the database is then processed using a dedicated algorithm which also takes various other parameters of the person like weight, height etc. to get an accurate reading of the hydration level of that person or creature.

[0187] Additionally, the device’s microcontroller and software can save data for up to four hours, but can be configured to save data for as many hours as needed. This sensor has a microcontroller and can be used as a standalone device to measure hydration levels. A person does not need to carry a phone with them for monitoring while they are doing physical activity unless they want to. They can carry this device alone. They can put this device on their arm and go to a physical activity. The device will store data for four hours, but can be configured to store data for longer or shorter periods of time. Every time the device reconnects with the phone, it will dump all the data to the phone. This sensor can be embedded in a device, for example, if a person has If you have a watch, you can connect the sensor and use Go for a run so you can see real-time data, too.

[0188] Once the sensor readings are obtained, the readings are converted into a hash, i.e. into a hash format so that it becomes one long string, which is sent from the microcontroller to the phone and then from the phone to the server. All this data in the server is stored in a hash format. When analyzing, the encrypted data is decrypted and the readings are obtained.

[0189] In one embodiment, the pulse measurement is controlled by the electronics, while in another embodiment, the pulse measurement is controlled by external software.

[0190] The device also collects other parameters such as age and weight. These factors need to be taken into account because some people excrete more salt and their sensors are calibrated accordingly. When the device recognizes that the electrolytes are less than they should be, it identifies dehydration and then sounds an alarm.

[0191] For example, during a workout, a person may not sweat at first, so the measurement is zero. Then perhaps after 10 to 15 minutes a person starts sweating, so the hydration curve drops, indicating a low hydration level. Whenever water is ingested, about three minutes later, the hydration state increases, represented by a small peak, and marked with a red arrow to identify significant changes in the graph. The algorithm calculates hydration level and rehydration level.

[0192] An excitation of a pulsating direct current pulsed at a predetermined frequency is provided to prevent polarization of ions in the fluid at the electrode pair.

[0193] The ion sensing circuit determines ion concentration information of the fluid over time.

[0194] The microcontroller determines the physiological state of the subject based on the ion concentration information of the fluid over time.

[0195] The physiological state of the subject includes at least one of a hydration state and a glucose state.

[0196] A database comprising conductivity information of at least one fluid of a subject, first ion concentration information of the at least one fluid obtained at a first moment, second ion concentration information of the at least one fluid obtained at a second moment, measurement information of at least one parameter of the subject (e.g., age, weight, height, etc.), multiple environmental parameters that affect sensor readings (e.g., humidity, temperature, pressure), location data with latitude, longitude, and altitude information, a timestamp of the date and time when the measurement occurred or was performed, and an indicator of the subject's physiological state (e.g., hydration level). The database also includes user habits, such as liquid intake, food intake, etc.

[0197] In one embodiment, the device uses carbon-printed electrodes that are placed on top of the skin to obtain hydration data from sweat, and the device is intended for multiple uses rather than disposable.

[0198] In one embodiment, the device measures electrolytes in sweat using a pulse frequency of DC current with a frequency not exceeding 200 Hz.

[0199] In one embodiment, the device includes flexible carbon printed electrodes with an adhesive on one side for inclusion on clothing, wearable devices.

[0200] In one embodiment, it is a system consisting of an electrode pair, a temperature sensor, and a data acquisition system or a microcontroller to measure the electrolyte concentration of sweat.

[0201] In one embodiment, it is a system consisting of electrode pairs, temperature sensors, and a data acquisition system or microcontroller to measure the electrolyte concentration of sweat, where a machine learning algorithm is used to determine the user's hydration level based on electrolyte levels, body temperature, weight, height, weather conditions obtained from real-time internet location data through an app, heartbeat, etc.

[0202] In one embodiment, a circuit for measuring sweat conductivity consisting of 2 resistors and 1 capacitor makes the entire system a low-cost product.

[0203] In one embodiment, it is an additional sensor for other existing wearable devices, capable of transmitting data via Bluetooth.

[0204] In one embodiment, it is a device comprising: a sensor having a carbon printed electrode disposed on a flexible substrate having an adhesive on one side and an ion sensing circuit on the other side.

[0205] In one embodiment, it is a sensor comprising carbon printed electrodes disposed on a flexible substrate with an adhesive on one side and an ion sensing circuit on the other side.

[0206] In one embodiment, it is a sensor comprising carbon printed electrodes disposed on a flexible substrate with an adhesive on one side and an ion sensing circuit on the other side made into a standalone device, with or without a display.

[0207] In one embodiment, it is a device together with a database.

[0208] Although various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the appended claims.

[0209] References

[0210] US Patent Application Publication 20160338639A1; US ​​Patent Application Publication 20180263539A1, US Patent 10092203B2; US Patent 8734341B2; US Patent 7783344B2; WO2016030869A1. All patents, patent application publications, and non-patent literature mentioned in this application are incorporated herein by reference in their entirety.

Claims

1. A device comprising: A sensor, the sensor comprising an electrode pair located on a flexible substrate, the electrode pair comprising a first electrode and a second electrode; as well as Ion sensing circuit; The electrode pair is arranged in such a manner that the first electrode is close to the second electrode; wherein the sensor is electrically connected to the ion sensing circuit, and the ion sensing circuit includes a microcontroller that generates a DC pulse signal stimulus; wherein the microcontroller reads only the resistance through the DC pulse signal stimulation; and The device is configured to determine an ion concentration in a fluid of the subject based on the electrical resistance.

2. The apparatus of claim 1, wherein the ion sensing circuit further comprises: a first resistor; a capacitor electrically connected in series with the first resistor; a second resistor electrically connected in parallel with the electrode pair; a first node, to which the read node is electrically connected; and Second node; wherein the first node establishes a first electrical connection between the capacitor and a parallel connection of the second resistor and the electrode pair; and The second node establishes a second electrical connection between the capacitor and a parallel connection of the second resistor and the electrode pair.

3. The device of claim 1, wherein the device is configured to determine hydration level by detecting ionic concentration of salt.

4. The device of claim 1, wherein the electrode pairs are carbon printed and configurable into different shapes.

5. The device of claim 1, wherein the electrode pair is carbon printed on one side of the flexible substrate and an adhesive is on the other side.

6. The apparatus of claim 1, wherein the electrode pairs have an area and a distance between the electrode pairs, wherein the area and the distance between the electrode pairs can be changed.

7. The apparatus of claim 2, wherein the read node is electrically connected to a transmitter.

8. The device according to claim 1, wherein the microcontroller is configured to control an energy source and provide the pulse signal stimulation.

9. The device of claim 1, wherein the device is wearable and portable.

10. The device of claim 1, wherein the device is attachable to a garment.

11. The device of claim 1 , wherein the device is flexible.

12. The device of claim 1, wherein the device comprises a transmitter and a receiver.

13. The device according to claim 1, wherein the frequency range of the DC pulse signal stimulation is 0 to 200 Hz.

14. The apparatus of claim 1, wherein the DC pulse signal stimulation is from a pulsating DC current comprising a predetermined time delay between individual pulses of the pulse signal stimulation.

15. The apparatus according to claim 14, wherein the predetermined time delay between each pulse of the DC pulse signal stimulation is at least 5 microseconds.

16. The device of claim 1, wherein the device further comprises wireless communication circuitry configured to perform wireless transmission and reception.

17. The device of claim 16, wherein the wireless communication circuit supports a wireless connection, the wireless connection comprising Bluetooth, WiFi, BLE, radio frequency signal, GSM.

18. The device of claim 16, wherein the wireless communication circuitry transmits data wirelessly to a wearable and portable smart handheld device.

19. The device of claim 18, wherein the intelligent handheld device comprises a personal digital assistant.

20. The apparatus of claim 1, wherein the objects include living and non-living things.

21. The device of claim 1, wherein the fluid comprises body fluids, any fluid containing electrolytes, steam from plants.

22. The apparatus of claim 21, wherein the body fluid comprises biological sweat, and / or wherein the electrolyte-containing fluid comprises urine.

23. The apparatus of claim 1, wherein the ion sensing circuit is configured to detect conductivity of the fluid in real time.

24. The apparatus of claim 1, wherein the electrode pair is in non-invasive contact with the subject.

25. The apparatus of claim 1, wherein the sensor is configured to measure at least one parameter of the object that affects an ion concentration of the fluid.

26. A sensor comprising: An electrode pair, the electrode pair being located on a flexible substrate, the electrode pair comprising a first electrode and a second electrode, the first electrode being close to the second electrode; as well as An ion sensing circuit, the ion sensing circuit comprising: Microcontroller; a first resistor; a capacitor electrically connected in series with the first resistor; a second resistor electrically connected in parallel with the electrode pair; a first node and a read node electrically connected to the first node; and Second node; wherein the first node establishes a first electrical connection between the capacitor and a parallel connection of the second resistor and the electrode pair; The second node establishes a second electrical connection between the capacitor and the parallel connection of the second resistor and the electrode pair; The sensor is electrically connected to the ion sensing circuit, which includes a microcontroller that generates a DC pulse signal stimulus; wherein the microcontroller reads only the resistance through the DC pulse signal stimulation; and The sensor is configured to determine an ion concentration in a fluid of a subject based on the electrical resistance.

27. A method comprising: securing the device of claim 1 to a surface of an object; Excitation is provided by applying a pulsed direct current pulsed at a predetermined frequency to the sensor by an energy source; determining an ion concentration of a fluid in real time over a period of time, which includes a first reading and a second reading; communicating with a database the ion concentration of the fluid over a period of time; extracting the physiological status information of the subject based on the difference between the first reading and the second reading; and The physiological status information of the subject is displayed through a display, the device and a smart handheld device.

28. A system comprising: A sensor, the sensor comprising: an electrode pair, the electrode pair being located on a flexible substrate, the electrode pair comprising a first electrode and a second electrode, the first electrode being close to the second electrode; and An ion sensing circuit, the ion sensing circuit comprising: Microcontroller; a first resistor; a capacitor electrically connected in series with the first resistor; a second resistor electrically connected in parallel with the electrode pair; a first node to which the read node is electrically connected; and Second node; wherein the first node establishes a first electrical connection between the capacitor and a parallel connection of the second resistor and the electrode pair; The second node establishes a second electrical connection between the capacitor and the parallel connection of the second resistor and the electrode pair; The sensor is electrically connected to the ion sensing circuit, which includes a microcontroller that generates a DC pulse signal stimulus; wherein the microcontroller reads only the resistance through the stimulation of the DC pulse signal; The sensor is configured to determine an ion concentration in a fluid of a subject based on the resistance, and The sensor communicates with the second system via a wireless communication device, and the second system includes a processor, a memory communicating with the processor, a communication module, a display, and a database.

Images