WO2016099824A1 - Systèmes et procédés de mesure de bio-impédance - Google Patents

Systèmes et procédés de mesure de bio-impédance Download PDF

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Publication number
WO2016099824A1
WO2016099824A1 PCT/US2015/062375 US2015062375W WO2016099824A1 WO 2016099824 A1 WO2016099824 A1 WO 2016099824A1 US 2015062375 W US2015062375 W US 2015062375W WO 2016099824 A1 WO2016099824 A1 WO 2016099824A1
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WO
WIPO (PCT)
Prior art keywords
electrodes
pair
data
current
tissue
Prior art date
Application number
PCT/US2015/062375
Other languages
English (en)
Inventor
Jose L. Bohorquez
Juan Jaramillo
Elmer C. Lupton
Seward RUTKOVE
Haydn Taylor
Gonzalo CESPEDES
Cary Liberman
Dmitri Khrebtukov
Claudio Cassina
Yensy HALL
Stanislava DARASHKEVICH
Original Assignee
Skulpt, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Skulpt, Inc. filed Critical Skulpt, Inc.
Publication of WO2016099824A1 publication Critical patent/WO2016099824A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0537—Measuring body composition by impedance, e.g. tissue hydration or fat content
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4519—Muscles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6887—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient mounted on external non-worn devices, e.g. non-medical devices
    • A61B5/6898—Portable consumer electronic devices, e.g. music players, telephones, tablet computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0431—Portable apparatus, e.g. comprising a handle or case
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0462—Apparatus with built-in sensors
    • A61B2560/0468—Built-in electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/046—Arrangements of multiple sensors of the same type in a matrix array

Definitions

  • Embodiments of the present disclosure disclose systems and methods for measuring, tracking, and/or managing the health of individual body parts.
  • the systems and devices of the present disclosure enable the measurement of health-related parameters in localized regions of a user's body.
  • EIM electrical impedance myography
  • Sustained exercise including aerobic and anaerobic activities such as running, cycling, and weight lifting, can produce muscle fatigue.
  • a variety of physiological alterations occur in muscle, including the development of muscle edema (swelling), muscle fiber rupture, and hyperemia (increased blood flow).
  • the degree and time course of recovery from these alterations depends on the type, duration, and intensity of the exercise performed.
  • Recovery time can be short (e.g., a few minutes with minor exercise) or long (e.g., days or even weeks after sustained intense exercise) depending upon the intensity and duration of the exercise.
  • muscle will be at a reduced capacity. Over time, this exercise-injury-recovery cycle can actually lead to enhanced physiological condition of the muscle. However, in cases of excessive use, it can lead to overtraining and muscle injury. Other factors that can also impact recovery also include nutrition and overall health status. Thus, it may be desirable to perform EIM measurements during, or immediately after, exercise.
  • EIM measurement systems of the prior art are large and immobile, and require complex and fragile electronic equipment. Consequently, EIM measurements using such systems are relatively expensive and slow.
  • the large size and complex circuitry of these prior art systems limit their use in EIM measurements of users who are mobile and/or engaged in exercise.
  • the systems and methods of the present disclosure may alleviate some of the above-described deficiencies.
  • the scope of the current disclosure is defined by the attached claims, and not by its ability to solve a specific problem.
  • the devices and methods of the current disclosure enable the calculation of health related parameters (e.g., parameters indicative of fat content, such as, e.g., fat percentage and muscle quality (MQ)) for a specific body region (e.g., arms, legs, and/or core) or muscle (e.g., biceps, abdominal muscle, etc.) by measuring the bioimpedance of that region of the body directly.
  • health related parameters e.g., parameters indicative of fat content, such as, e.g., fat percentage and muscle quality (MQ)
  • MQ fat percentage and muscle quality
  • Known bioimpedance measurement systems measure parameters related to global fat content (such as, e.g., regional fat %, segmental fat %, etc.) in a different way.
  • the fat percentage of a user's muscles is obtained by placing a plurality electrodes (e.g., four) of the device on the biceps, measuring the bioimpedance of tissue in the biceps, and computing an estimate of the fat content from the measured parameters.
  • bioimpedance measurement systems where bioimpedance is measured by positioning electrodes across a relatively large region of the body (between one hand and the other, between one foot and the other, etc.), electrical current finds the path of least resistance.
  • Fat tissue typically has relatively higher resistance.
  • the applied current flows into, e.g., the foot and then primarily through lean tissue which includes veins and arteries.
  • the disclosed systems include a portable, hand-held device, and the disclosed methods include methods to assess health and fitness of localized regions of tissue.
  • the disclosed device, associated software, and associated methodology provides an instrument and method for measuring parameters related to muscle health and fitness, muscle fatigue and recovery in localized body parts.
  • the device may be wireless, hand-held, portable, wearable, or incorporated in a garment configured to be worn by a user.
  • Some embodiments of the device may include a display or other indicators such as light-emitting diodes (LEDs), organic LEDs (OLEDs), liquid crystal display (LCD), color-changing fabrics, speaker(s), etc. for immediate feedback of the measured results.
  • the device may include switches, selectable icons, buttons, or other control mechanisms to control the operation (e.g., to initiate a measurement, configure, etc.) of the device.
  • the disclosed device may not include a display and/or control mechanisms, and control of the device and presentation of results measured by the device may be performed by an associated device (e.g., a smartphone) wirelessly connected with the disclosed device.
  • an associated device e.g., a smartphone
  • the device includes multiple electrodes arranged in a pattern, and measurements may be made using multiple electrode configurations and frequencies. The data from these measurements may be used to calculate parameters related to localized bioimpedance of the measured region.
  • the disclosed device may be a standalone component (i.e., operate independently of other hardware) handheld device, a device connected or wirelessly linked to an associated device (e.g., a phone, tablet, computer, exercise machine, etc.), a small wearable device integrated with, or removably attachable to, a supporting structure (e.g., belt, strap, headband, armband, etc.), and/or integrated with or removably attached to wearable garment (e.g., a shirt, shorts, or pants), etc.
  • a standalone component i.e., operate independently of other hardware
  • an associated device e.g., a phone, tablet, computer, exercise machine, etc.
  • a small wearable device integrated with, or removably attachable to, a supporting structure e.g., belt, strap, headband, armband, etc.
  • wearable garment e.g., a shirt, shorts, or pants
  • electrodes operably linked to other portions of the disclosed apparatus and system may be suitably integrated with wearable garments using any suitable manner.
  • the electrodes may be woven into the fabric using conductive material, and electrically connected to electronics that perform the measurements.
  • the electrodes may be screen printed or otherwise secured on, e.g., an inner a garment such as a fitted shirt. As a result, the screen printed electrodes may be held in close contact to a user's skin.
  • the electrodes may be secured to a wearable garment via, e.g., an adhesive.
  • the disclosed devices and methods may be used for measuring/tracking and/or managing the health (e.g., percentage of fat and/or muscle, muscle quality, etc. in individual muscle groups) of individual body parts.
  • the device may include an electrode array comprising a plurality or electrodes arranged at different angles and distances.
  • the electrode array may be placed in contact with a desired measurement location (e.g., biceps, chest, abdomen, quadriceps, triceps, gastrocnemius, forearms, back muscles, gluteus maximus, etc.) on the body of a user, and measurements initiated.
  • a desired measurement location e.g., biceps, chest, abdomen, quadriceps, triceps, gastrocnemius, forearms, back muscles, gluteus maximus, etc.
  • Measurements may be initiated using the device (e.g., by pressing a button on the device) or using a linked associated device (e.g., by pressing a button on a computer, an icon of a software application running on a smartphone, etc.).
  • a multi-frequency electrical current signal is applied to the measurement location through multiple electrode pairs of the electrode array and
  • the device may include electrical/electronic circuits (e.g., integrated circuits such as a microprocessor, etc.) to make the measurements and to calculate health-related parameters based on the resulting data.
  • electrical/electronic circuits e.g., integrated circuits such as a microprocessor, etc.
  • profile information e.g., age, gender, weight, height, race, temperature, etc.
  • the calculated parameters may include parameters such as muscle percentage, fat percentage, muscle quality, muscle fitness, and muscle health, etc.
  • the calculated parameters may be displayed on a screen of the device (LED, LCD, Thin Film Transistor, Organic LED, etc.) or may be shown using other indicators such as color-changing fabrics, lights, speakers, etc.
  • the calculated parameters may be sent (wirelessly, or through wires) to an associated device
  • the raw data collected by the device may also be sent to the associated device.
  • Any known wireless communication technology e.g., Bluetooth, Wi-fi, Zigbee, etc.
  • Bluetooth, Wi-fi, Zigbee, etc. may be used to transmit information (data, computed parameters, instructions, signals, etc.) between the device and its associated devices.
  • low energy Bluetooth may be used to transfer information between the devices.
  • the disclosed device and/or the associated device may transfer some or all of the received information to a central database (e.g., on the cloud) over the internet.
  • the central database may be configured to store the data and present results in a variety of ways. The user may access the database over the internet and review these results using a personal computer, smartphone, tablet, or a similar device.
  • the disclosed device and/or the linked associated device may be configured to transfer or output the measured data and/or the computed results to third-party health-tracking software for tracking, to participate in group health activities, etc.
  • the disclosed device and/or the linked associated device may be configured to access, download, and/or link to third-party websites (or software) to provide health-related information to the user.
  • the user may be able to obtain and track the health of specific regions of his body, get health-related information (for example, an exercise to improve the health of any particular region), and participate in health-related group activities, etc.
  • the disclosed device and method may be capable of measuring/tracking and/or managing the level of fatigue/injury in muscles as a result of activity, as well as the rate and level of recovery. This is based on the unexpected observation that certain bioimpedance parameters change dramatically in response to muscle exertion.
  • a portable device for measuring bioimpedance-related properties of tissue may include a portable housing, a power supply in the housing, and a plurality of electrodes on a surface of the housing.
  • the plurality of electrodes may include a first pair of current electrodes and a corresponding first pair of voltage electrodes positioned between the first pair of current electrodes.
  • the device may also include electronic circuitry in the portable housing. The electronic circuitry may be configured to (a) obtain data by directing current into the tissue through the first pair of current electrodes and measuring a voltage across the corresponding first pair of voltage electrodes, and (b) calculate at least one bioimpedance-related property of the tissue based on the obtained data.
  • Embodiments of the disclosed device may include one or more of the features described below.
  • the portable housing may include a display configured to indicate the calculated bioimpedance-related property.
  • the housing may include at least one indicator configured to indicate a status of the measurement to a user. At least one indicator may be configured to indicate at least one of when (a) the plurality of electrodes make contact with the tissue and (b) when the measurement is complete. Each of the first pair of current electrodes may be larger in size than the corresponding first pair of voltage electrodes.
  • the electronic circuitry may be further configured to wirelessly transmit at least the calculated bioimpedance-related property to an associated device adapted to display the bioimpedance- related property.
  • the associated device may include one of a cellular phone, a computer, a tablet, and an exercise machine.
  • the electronic circuitry may be configured to calculate at least one of (i) a fat percentage of the tissue and (ii) a muscle percentage of the tissue using the obtained data.
  • the electronic circuitry may be further configured to calculate a muscle quality of the tissue as a ratio of the muscle percentage to the fat percentage.
  • the device may further include a light ring extending around a periphery of the device. The light ring may be configured to illuminate to indicate a status of the device.
  • a portable device for measuring bioimpedance-related properties of tissue may include a plurality of electrodes.
  • the plurality of electrodes may be configured to be simultaneously placed in contact with the tissue.
  • the plurality of electrodes may include a first set of electrodes arranged along a first axis.
  • the first set of electrodes may include a first pair of current electrodes and a first pair of voltage electrodes positioned between the first pair of current electrodes, and a second pair of current electrodes and a second pair of voltage electrodes positioned between the second pair of current electrodes.
  • the plurality of electrodes may also include a second set of electrodes spaced apart and arranged along a second axis non-collinear with the first axis.
  • the second set of electrodes may include a third pair of current electrodes and a third pair of voltage electrodes positioned between the third pair of current electrodes.
  • Each electrode of the first, second, and third pairs of current electrodes and voltage electrodes may be spaced apart from the other electrodes of the first, second, and third pairs of current electrodes and voltage electrodes.
  • the device may also include electronic circuitry configured to obtain (i) first data by directing current at multiple frequencies through the first pair of current electrodes and measuring the voltage across the first pair of voltage electrodes, and (ii) second data by directing current at multiple frequencies through the third pair of current electrodes and measuring the voltage across the third pair of voltage electrodes.
  • Embodiments of the disclosed device may include one or more of the features described below.
  • the device may further include a screen configured to display a parameter related to at least the first data and the second data.
  • the electronic circuitry may be configured to wirelessly transmit a parameter related to at least the first data and the second data to an associated device configured to display the parameter.
  • the electronic circuitry may be further configured to (iii) obtain third data by directing current at multiple frequencies through the second pair of current electrodes and measuring the voltage across the second pair of voltage electrodes.
  • the electronic circuitry may be further configured to calculate a bioimpedance-related property as a function of one or more of the first data, the second data, and the third data.
  • a method of measuring a characteristic of a user's tissue may include positioning a plurality of electrodes of a portable device in contact with a first location of the tissue.
  • the plurality of electrodes may include a first pair of current electrodes and a corresponding first pair of voltage electrodes.
  • the method may also include obtaining data by directing a current into the first location of tissue through the first pair of current electrodes and measuring a voltage across the corresponding first pair of voltage electrodes.
  • the method may further include calculating at least one characteristic of the tissue at the first location based on the obtained data.
  • Embodiments of the disclosed method may include one or more of the aspects described below.
  • the method may further include repeating the steps of positioning, obtaining, and calculating at a plurality of locations of the tissue.
  • Each of the plurality of locations may include a muscle group that differs from a muscle group of the other plurality of locations.
  • the method may further include calculating a whole body characteristic of the user as a function of the at least one characteristic calculated for the plurality of locations.
  • the whole body characteristic may include at least one of a total body fat percentage, total body muscle percentage, and total body muscle quality.
  • the method may further comprise wetting the plurality of electrodes or the tissue prior to positioning the plurality of electrodes in contact with the tissue.
  • FIG. 1 illustrates an overview of the system including an exemplary aspect of the disclosed device.
  • FIG. 2 illustrates several views of the device of FIG. 1.
  • FIG. 3 illustrates how data stored in the system can be reviewed using any associated device.
  • FIGS. 4A-4I illustrate an exemplary process of setting up an associated device to operate the device of FIG. 2.
  • FIGS. 5A-5E illustrate an exemplary process of syncing the associated device with the device of FIG. 2.
  • FIGS. 6A-6J illustrate an exemplary process, via screenshots of a mobile device, for obtaining baseline measurements of a user's body using the associated device and methods.
  • FIGS. 7A-7I illustrate an exemplary process of reviewing tutorials on the associated device.
  • FIGS. 8A-8E illustrate an exemplary process of reviewing measurement results on the associated device.
  • FIGS. 9A-9F illustrate an exemplary processing of reviewing measurement results on the device of FIG. 2.
  • FIG. 10A illustrates an exemplary electrode array of the device of FIG. 2.
  • FIGS. lOB-lOC illustrate other exemplary electrode arrays of the device of FIG. 2.
  • FIG. 1 1 illustrates the device of FIG. 2 being used to take measurements on a muscle, such as, e.g., the bicep of a user.
  • FIG. 12 is a schematic illustration of exemplary electronic circuitry of the device of FIG. 2.
  • FIG. 13 illustrates another exemplary embodiment of the disclosed device.
  • FIGS. 14A-14C illustrates another exemplary embodiment of the disclosed device.
  • FIG. 15 illustrates another exemplary embodiment of the disclosed device.
  • FIGS. 16A-16B illustrates other exemplary embodiments of the disclosed device.
  • FIG. 17 is a plot of exemplary results obtained by the device as a function of time.
  • FIG. 18 is a table showing the results of FIG. 17.
  • FIGS. 19-20 are tables showing other exemplary results obtained by the device. DETAILED DESCRIPTION OF THE DISCLOSURE
  • the terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
  • the term “exemplary” is used in the sense of “example,” rather than “ideal.”
  • FIG. 1 illustrates an overview of an exemplary system of the current disclosure.
  • the system includes a device 10 used to measure EIM or any type of data related to the bioimpedance of a user.
  • Bioimpedance refers to the electrical properties of a biological tissue, measured when current flows through it. Bioimpedance varies with the current frequency and tissue type, and may be used as a measure of the body composition (e.g., percentage of body fat in relation to lean body mass). EIM and other metrics related to bioimpedance may play an important part of any comprehensive health and nutrition assessment of a user.
  • Device 10 may be a portable device. In general, device 10 may have any size and shape. In some embodiments, device 10 may have a length and width between about 0.5-6 inches. In some embodiments, device 10 may have a width of about 2.5 inches and a length of about 3.5 inches. In this disclosure, relative terms such as "about,”
  • the device may have a circular, oval, or other curved footprint or profile (see, for e.g., FIG. IOC).
  • device 10 may be configured to be attached (for example, strapped) to a user (for example, at the bicep) during exercise.
  • device 10 may include straps (or loops or openings configured to pass a strap) that may be used to attach the device 10 snugly to the user's body.
  • a user may merely press the device 10 against his/her skin to take a measurement.
  • the electrodes may be woven into fabric on a garment such as a shirt, shorts, pants, or socks, and connected to electronics that perform the measurements, as alluded to above.
  • FIG. 2 illustrates several views of an exemplary device 10.
  • Device 10 may include one or more buttons 14 to navigate and control the device 10 (e.g., initiate measurements, etc.).
  • device 10 may include any number (1, 2, 3, 4, etc.) of buttons 14 positioned on any location in the device 10. In some embodiments, the number of buttons 14 may be three.
  • physical buttons are illustrated in these figures, it should be noted that in some embodiments, some or all of these buttons 14 may be software-generated icons that appear on a display screen of the device 10.
  • Device 10 may include a display screen (display 12) configured to display data.
  • Display 12 may be of any type (e.g., thin film transistor (TFT), liquid crystal display (LCD)), organic light emitting diode (OLED), etc.). In a preferred embodiment, an OLED display may be used. Display 12 may have any size and shape, and may be positioned at any location on the device. In some embodiments, the display 12 may be positioned on a front-side 6 (or a non skin contacting side) of the device. In some embodiments, the display 12 may extend substantially over the entire front-side 6 of the device 10.
  • Device 10 may be powered by a battery (not shown). In some embodiments, the battery may be a rechargeable battery.
  • device 10 may be configured to initiate measurements automatically when the device 10 senses that the electrodes are making proper contact with a user's skin.
  • one or more electrodes of device 10 may be configured to continuous or periodically deliver relatively small amounts of current. It is contemplated that once the electrodes are properly positioned on the user's skin, these small amounts of current may be transmitted through the user's skin and detected by other electrodes 18, to confirm correct positioning on the user's skin. Once suitable amounts of the delivered current is detect by one or more electrodes 18, device 10 may be configured to initiate measurements In some embodiments, measurements are made periodically to detect changes in the tissue over time. That is, a plurality of measurements may be made with one or more
  • the measurements may be made continuously. That is, a plurality of measurements may be made in succession with little to no time delay between each measurement.
  • sensed data may be stored in a local memory on the device. The data may be analyzed on the device via a suitable processor and/or transmitted wirelessly to another device or a database, for later analysis. Those of ordinary skill will recognize that some or all of the obtained data (e.g., data for a particular set of measurements, data spanning a particular time period, data falling within certain predefine criteria or threshold) may be transmitted wirelessly to linked device or database. If necessary, the linked device or database may be configured to request additional such as a complete set of data relating to all measurements.
  • Device 10 may include a plurality of electrodes 18 to measure data associated with the bioimpedance of a body part of the user.
  • these electrodes 18 may be positioned at any location on the device 10.
  • the electrodes 18 may be positioned on the side opposite front-side 6. That is, the electrodes 18 may be positioned on the back-side 8 (or a skin contacting side) of the device 10.
  • FIG. 2 illustrates the electrodes 18 as being positioned on a side opposite the display 12, this is not a requirement.
  • the electrodes 18 may be positioned alongside the display 12, or on a side adjacent to the display 12.
  • the electrodes 18 may be kept in contact with a region of the user's body (e.g., bicep, thigh, etc.) and the measurement initiated.
  • the measurement may be initiated by any method.
  • a measurement may be initiated by pressing a button 14 of device 10.
  • the measurement may be initiated by pressing a button or an icon (e.g., in an software app) of an associated device 37 (see FIG. 1).
  • the measurement may be initiated automatically when the device recognizes that sensors are making proper contact.
  • the associated device 37 may be any type of electronic device that is configured to exchange information (data, signals, etc.) with device 10.
  • the associated device 37 may be a smartphone, tablet, smartwatch, computer, exercise machine (e.g., treadmill, elliptical), etc. that is communicatively coupled to device 10 for exchange of information.
  • information may be exchanged by any method (wirelessly, using a wired connection, optical, transferred using a physical medium such as a memory stick, etc.) between devices 10 and 37.
  • information may be exchanged wirelessly using any wireless or mobile phone communication technology (Bluetooth, WiMax, Wi-Fi, ZigBee, Microwave, Infrared, 3G, 4G, etc.).
  • the measurement of each region may take any amount of time. In some embodiments, each measurement may take less than 2 seconds. After completion of the measurement of one region (e.g., bicep), the device 10 may be moved to another region (e.g., thigh) to take measurements.
  • the device 10 may inform the user of the completion.
  • the device 10 may use any method to inform the user (for example, by emitting a sound, vibration, light, display changing color, etc.).
  • device 10 may include a light or an indicator to relay measurement status information (e.g., status of electrode contact to the user's body, measurement has been initiated, measurement is completed, etc.) to the user.
  • measurement status information e.g., status of electrode contact to the user's body, measurement has been initiated, measurement is completed, etc.
  • the light may be activated to indicate that all electrodes 18 have made good contact with the skin, etc.
  • a light ring may be activated to indicate that all electrodes 18 have made good contact with the skin, etc.
  • the 16 positioned around the device 10 may be used to relay measurement status information (e.g., when the device is ready to take a measurement, when a measurement is complete, etc.) to the user.
  • the light ring 16 may be used to inform the user that good contact is made, a measurement has been initiated, and a measurement has been completed.
  • vibration, sound, or another signal that can be sensed by the user may indicate the measurement status.
  • the device 10 may also inform the user when a measured parameter is outside an expected range.
  • the device 10 may beep (i.e., alert by emitting a sound), vibrate, activate light ring 16, etc. when the results of a measurement are outside of a normal range and/or outside an expected range
  • device 10 may be designed to be splash proof or otherwise water resistant. That is, device 10 may include a hermetically sealed outer case to protect, e.g., internal electronics. In a preferred embodiment, device 10 may be fully submersible and thus water-proof.
  • FIG. 2 illustrates an embodiment of a device 10 integrated with electrodes 18 and display 12 in a single housing, this is only exemplary. In some
  • the device 10 may include the electrodes 18 for making measurements, and the display 12 may be integrated with another device (e.g., associated device 37) that is linked (e.g., wirelessly connected) to the device 10.
  • another device e.g., associated device 37
  • linked e.g., wirelessly connected
  • measured data may be transmitted from device 10 to the linked associated device 37 for computation and/or display.
  • the electrodes may be transmitted from device 10 to the linked associated device 37 for computation and/or display.
  • the electrodes may be transmitted from device 10 to the linked associated device 37 for computation and/or display.
  • the electrodes may be transmitted from device 10 to the linked associated device 37 for computation and/or display.
  • the electrodes may be transmitted from device 10 to the linked associated device 37 for computation and/or display.
  • the electrodes may be transmitted from device 10 to the linked associated device 37 for computation and/or display.
  • detachable sensors 18 may be in the form of one or more detachable sensors that are attached to the user or to garments (e.g., headband, wristband, strap, chest band, shirt, shoes, shorts, socks, etc.) worn by the user.
  • These detachable sensors may connect (wirelessly or through a wired connection) to the device 10 or the associated device 37 and transfer the data measured by the sensors.
  • initiation of measurements of these detachable sensors may be made using the associated device 37 (e.g., using a software application running on the associated device 37).
  • the device 10 and/or the electrodes 18 may be in the form of one or more flexible components (e.g., electrodes 18 and related circuitry patterned on a flexible substrate) that may be attached to desired locations (e.g., bicep, chest, etc.) of a user like a sticker.
  • desired locations e.g., bicep, chest, etc.
  • the device 10 may measure data and display the measured data on display 12.
  • the device 10 may analyze the measured data and compute health parameters 35 (see FIG. 1) related to the health of the user.
  • the health parameters 35 may include metrics related to the user's physical heath (e.g.,, muscle percentage, fat percentage, muscle quality (MQ), etc.).
  • the device 10 may display all or a portion of these computed parameters 35 on display 12. Additionally or alternatively, in some embodiments, the device 10 may direct some (or all) of the measured data and computed parameters 35 to the associated device 37.
  • device 10 may send the parameters 35 to the associated device 37 by any method (over a wire, wirelessly, or transferred in a transferable storage medium, etc.).
  • the device 10 and associated device 37 may communicate wirelessly.
  • the parameters 35 may be formatted (or configured) in a manner suitable to be viewed using the associated device 37 having a suitable application installed therein.
  • the associated device 37 may transmit some or all of the parameters 35 to a computer system 40 for storage and/or further analysis (e.g., trend analysis, etc.).
  • a computer system 40 Any type of known computer (e.g., desktop, laptop, networked computers, server, etc.) may serve as computer system 40.
  • networked servers connected over the internet may serve as computer system 40.
  • a plurality of networked computers may serve as computer system 40.
  • an associated device 37 may itself function as the computer system 40.
  • Computer system 40 may include a storage medium with a database having parameters 35 from previous measurements stored therein.
  • Computer system 40 is described as including the storage medium with a database, it should be noted that the storage medium may be distributed across multiple networked computers (e.g., on a server farm) and the database may be stored in a cloud (e.g., a cloud computing system). Computer system 40 may store the transferred health parameters 35 in the database and, in some embodiments, perform analysis on the stored data. Computer system 40 may include known electronic devices
  • circuitry configured to perform the analysis.
  • the analysis may include tracking the variation of the user's health parameters 35 over time, etc.
  • the user may access the computer system 40 (e.g., over the internet) to review the results of the analysis.
  • the results of the analysis performed by the computer system 40 may be retransmitted to and displayed on display 12 of the device 10.
  • a user may log into computer system 40 to view the calculated parameters 35 and/or the trend analysis performed by the computer system 40 (e.g., variation of MQ over time).
  • a user may access the computer system
  • computer system 40 and/or the associated device 37 may also include software configured to control operation of the device 10. A user may use this software to operate the device 10
  • the user may access the software (e.g., using device 10, associated device 37, a web application, a desktop client, etc.) to setup the device 10 and to setup a profile.
  • the profile may allow the user to enter user specific information such as age, gender, weight, height, etc.
  • the system may enable multiple users to create profiles (for example, guest profiles) in a single device 10. Each user may access and modify their profiles and view their measured health parameters 35.
  • the software associated with computer system 40 and/or the associated device 37 may also enable the user to view exercise videos/tutorials and set motivational goals.
  • the software also may be configured to enable sharing of the parameters 35 and other data with friends directly or through social network sites to compare results.
  • the computer system 40 and/or the associated device 37 may be configured to access the Application Programming Interface (API) of companies that provide complementary information (such as sleep patterns, nutritional information, and other fitness information) and combine this information with the data stored in the computer system 40.
  • API Application Programming Interface
  • the system may compare and/or combine this third-party information with individual user data to educate the user on their health and well-being (for example, compare the user's metrics to known risk factors for disease, data from studies, etc.).
  • the system may customize exercise routines for the user to follow, and inform the user about maintenance of their health and fitness.
  • the user may be asked to manually select each body part via display 12 of the device 10 and/or the display (e.g., display 52 in FIGS.
  • the device 10 may be trained to recognize individual muscles so that measurement can begin as soon as the electrodes 18 come in contact with the user's skin.
  • measurements taken on the device 10 may be automatically synced with the user's profile on computer system 40 and/or the associated device 37 so that real time parameters 35 may be accessible to the user.
  • some or all of the health parameters 35 may be computed on the computer system 40 and/or the associated device 37 or by a third party having access to information obtained by device 10.
  • computer system 40 and/or the associated device 37 may allow the user to customize the device 10 (e.g., change the appearance and/or the type of information displayed on display 12, color of the light ring 16 and/or the display 12, etc.).
  • FIGS. 4A-9F An exemplary method of using an iPhone ® as an associated device 37 to operate a disclosed device 10 will now be described with reference to FIGS. 4A-9F.
  • a software application (app 50) is first downloaded to the associated device 37 from a suitable online site (such as, Itunes ® ).
  • FIG. 4A illustrates the downloaded app 50 on the display screen 52 of device 37.
  • the app 50 is opened (e.g., by clicking on it), a login window allows a registered user to "log in” and a new user to "sign up” (see FIG. 4B).
  • the app 50 sequentially displays multiple windows that allow the user to input profile information and select a login ID (e.g., an email address) and password for future login (see FIGS. 4C-4I).
  • a login ID e.g., an email address
  • password for future login
  • the requested profile information includes e.g., name, birthday, height, gender, weight, and whether the user is left or right handed.
  • any type of information can be requested from the user as profile information.
  • the app 50 then prompts the user to synchronize (sync) or pair the device 10 with the associated device 37
  • Synchronization or pairing operatively couples or links the associated device 37 with the device 10 so that the device 10 may be controlled/operated using the associated device 37.
  • the app 50 prompts the user to activate (i.e., turn on) the device 10 and select the "Add New User" icon that appears on the display 12 (of device 10) upon activation (see FIG. 5A).
  • the device 10 displays a PIN number on its display 12. Upon entering this
  • the associated device 37 synchronizes or pairs the device 10 with the associated device 37.
  • the associated device 37 can now be used to control the device 10 (change settings, initiate measurements, perform calculations, review results, etc.).
  • a single device 10 may be synced with multiple associated devices 37, and multiple devices 10 may be synced with a single associated device 37 using a similar procedure.
  • multiple users may also create separate accounts in the app 50 to use the same device 10 and associated device 37.
  • the app 50 will now prompt the user to obtain baseline measurements at selected locations (e.g., muscle groups) of the user's body using the device 10 (see FIGS. 6A-6J). These prompts may include illustrations and detailed instructions to assist the user in obtaining the baseline measurements.
  • the app 50 may sequentially display windows with detailed instructions
  • These instructions may include illustrations showing how to place the electrodes 18 of the device 10 at different body locations and measure the parameters at that location. Following these prompts, the user places the electrodes 18 (of device 10) against the skin at the body locations and initiates a measurement (e.g., by using a button 14 of device 10). In some aspects, the user may be prompted to apply a suitable fluid (e.g., water) to the skin prior to placement of the electrodes to improve electrode contact and conduction of electrical signals.
  • a suitable fluid e.g., water
  • the device 10 may indicate when each measurement is successfully completed, for example, by displaying a message on its display 12 and/or by using light ring 16.
  • the device 10 may also alert the user about an error in the measurement or setup process (e.g., when the electrodes 18 are not properly placed in contact with the skin) and/or when readings are outside of a normal or expected range.
  • the device 10 may also provide recommendations to rectify the error (e.g., wet the skin prior to placing electrodes thereon, etc.).
  • calculations may be performed by the device 10 and the results presented. The results may be presented in one or both of displays 12, 52 (see, e.g., FIGS.
  • the results may include muscle quality (MQ), fat percentage, muscle fatigue percentage, and information relating to muscle strength workout zone, which is discussed below in greater detail.
  • MQ muscle quality
  • the results may be displayed in any suitable manner.
  • the results may be displayed as a numerical value, via a heatmap, a position on a scale (e.g., the colored or shaded rainbow scale shown in Fig. 61), and/or via textual descriptors relating to fitness levels.
  • the display 52 of the associated device 37 may be used to make selections (such as, selections for setup, etc.) and review results.
  • the device 10 may take the measurements, perform the required calculations, and transmit the results to the associated device 37 for the user to review.
  • any setup process may be used to configure the device 10 using an associated device 37. It is also contemplated that in some embodiments, the entire setup process may be conducted using the device 10 without using an associated device 37.
  • the app 50 may also include tutorials to teach the functionalities of device 10 (see FIGS. 7A-7I).
  • the tutorial guides the user through a plurality of windows that assists the user in using the device 10 and reviewing results.
  • the tutorial may provide detailed information on the health-related parameters (e.g., MQ, FAT percentage, Muscle Fatigue percentage, Strength Workout Zones, etc.) that are computed by the device 10, how to view each of them, and how to switch between different available health-related parameters (see FIGS. 7B-7C).
  • the tutorial may also instruct the user on different formats for viewing the results (e.g., a snapshot of results for all the measured muscles, results of individual muscles, etc.) (see FIGS.
  • the app 50 may also include detailed information (e.g., instructional videos) on how to improve the health of different muscle groups (FIG. 71). By selecting a video, the user may be provided with information on how to improve the health of the selected muscle (e.g., suggested exercises, nutritional guidelines, etc.). In some embodiments, clicking on the image of a muscle illustrated on the display 52 may open a link to a website to access third- party information (e.g., third-party companies or information sites) that provides third- party information.
  • third- party information e.g., third-party companies or information sites
  • the user may login to the account at any time to select and view the results from any measurement (see FIGS. 8A-8E).
  • the results may be presented in any manner (table of results, line graphs, bar graphs, etc.).
  • the results and instructions may also be viewed on the device 10 (see FIGS. 9A-9F).
  • FIG. 9F illustrates a textual display of results
  • the results may be displayed in any manner (pictorially, graphically, etc.).
  • Each user may be able to create an account that can be used to store and access that user's data separate from other data.
  • Measured and calculated user data may be stored in one or more of the device 10, the associated device 37, or a remote computer 40.
  • a user may be able to select the user for whom measurements will be made. After selecting the user, the selected user's data can be collected, results calculated and presented.
  • each user may be distinguished by display color (font or any other indicator). For instance, when a first user is selected, the color of the display (or text, etc.) may be, for example, blue, and when a second user is selected, the color of the display/text may be, for example, red.
  • the data of each user may be protected by a password.
  • groups of users may be created using device 10 or 37. Individual users in a group may be able to compare their data and results with other users in the group. The comparison data may be presented in device 10 or 37. Individual users may be able to create groups, join groups and leave groups.
  • users can be assigned to groups by a third party.
  • user groups may formed as teams for competition and awards (or electronic badges) awarded based on improvements in performance or any other metric.
  • competitions may be coordinated by, and awards presented by, a user in the group or a third-party.
  • the device 10 may have the capability to store measurements and data of one or more users when not in communication with the associated device 37, and then transmit the data to the associated device 37 when communication is restored.
  • device 10 and/or the associated device 37 may be configured to share information with third-party software (e.g., health-tracking software such as HealthKit).
  • third-party software e.g., health-tracking software such as HealthKit
  • app 50 may include an API (Application Programming Interface) the enables third-party software to access measured data and/or computed results from device 10 and/or 37.
  • the device 10 and/or associated device 37 may also be configured to access and/or receive data from third-party software.
  • data related to the health of the user e.g., ECG, heart rate, pedometer data, calories burned, etc.
  • third- party devices iPhone ® , Fitbit ® , etc.
  • health-tracking software may be accessed by (or received) by device 10 or 37.
  • the data measured by device 10 and the received data may be used to compile a holistic health report of the user or create an exercise plan or regimen.
  • FIG. 10A illustrates an exemplary pattern of the electrodes 18 on the backside of device 10.
  • Electrodes 18 may include any electrically conductive material (e.g., copper, aluminum, silver, gold, etc.). In some embodiments, the electrodes 18 may be coated with
  • the electrodes 18 may protrude from the surface of the device 10 on which they are positioned. In some embodiments, the electrodes 18 may be flush with, or recessed relative to, the surface.
  • the electrodes 18 may include multiple conductive elements
  • twelve conductive elements 20 may be arranged in a pattern to allow different configurations to be used in a measurement.
  • the conductive elements 20 may be arranged in any desired pattern.
  • the conductive elements 20 may be arranged in a pattern about a central axis
  • electrodes 18 may include a plurality of conductive elements 20 spaced apart and arranged along a first axis 24 and a plurality of conductive elements 20 spaced apart and arranged along a second axis 26 perpendicular to the first axis
  • the conductive elements arranged along the first axis 24 may be symmetrically positioned about the second axis 26, and the conductive elements 20 arranged along the second axis 26 may be symmetrically positioned about the first axis 24. In some embodiments, the conductive elements 20 may be symmetric about both the first and second axes 24, 26.
  • four conductive elements (20i, 20j, 20k, 201) may be arranged to form the four sides of an inner square. These four conducive elements may have substantially the same length.
  • four additional conductive elements (20c, 20d, 20g, 20h) may be arranged to form the four sides of an outer square positioned radially outwards of the inner square. These four conductive elements may have a longer length than the conductive elements that comprise the inner square. Additional conductive elements (20a, 20b, 20e, 20f) having any length may be disposed outside the outer square.
  • some of these additional conductive elements may have substantially the same length as the conductive elements of the inner square and the remaining conductive elements may have substantially the same length as the conductive elements of the outer square.
  • one or more conductive elements of a shorter relative length and one or more conductive elements of a larger relative length may be disposed parallel to the conductive elements that make up two opposite sides of the outer square.
  • FIGS. 10B and IOC illustrate some other possible arrangement patterns of electrodes 18.
  • the plurality of conductive elements 20 are spaced apart and arranged symmetrically about the first and second axes 24, 26.
  • the number of conductive elements positioned along the first axis 24 is the same as the number of conductive elements arranged along the second axis 26.
  • the spacing of the conductive elements 20 along both the axes (24, 26) may also be substantially identical. In the embodiments of FIGS.
  • the electrodes 18 may include conductive elements disposed in two (or any number of) concentric circles.
  • the electrodes 18 may be oriented along an axis of the device 10, preferably along the long axis. In some embodiments, the electrodes 18 may not be oriented along an axis, but an orientation line or marker may be printed (or otherwise placed) on the device 10 to indicate to the user, the orientation of the electrodes 18. The user may use this marker to align the electrodes while taking a measurement. In some embodiments, an orientation line or marker may be printed (or otherwise placed) on the device 10 to indicate to the user, the orientation of the electrodes 18. The user may use this marker to align the electrodes while taking a measurement. In some
  • the device 10 may be positioned, with the electrodes 18 in contact with the tissue, over the muscle to be measured such that the orientation marker (or the long axis in embodiments where the electrodes are oriented along the long axis) is roughly oriented with the muscle fibers to be measured.
  • the orientation marker or the long axis in embodiments where the electrodes are oriented along the long axis
  • the user positions the device 10 by eye and feel such that the electrodes are generally oriented with the muscle fibers. Experiments have indicated that it is not necessary to align the device more accurately (e.g., by using a measuring device or other precise locator).
  • the electrodes 18 (or orientation marker) of device 10 are aligned as described below. Biceps - Oriented along arm bone; Triceps - Oriented along arm bone (between shoulder bone and elbow); Abs (or Waist) - Oriented in front of body roughly parallel to (and in some cases, laterally offset from) the backbone (the edge of the device is placed about 1 cm to the left or right of the navel with the vertical center of the device roughly aligned with the navel.
  • the long side of the device may be aligned with the torso); Quads - Oriented along leg bone; Shoulder - Oriented along the arm bone; Inner Forearm/wrist flexor - Oriented along forearm bone; Outer Forearm/wrist extensor - Oriented along forearm bone; Chest - Oriented roughly parallel to the torso (for men, middle of device is positioned over nipple, and for women, the bottom of the device is positioned about 1 cm above the nipple and the long axis of the device is roughly co-linear with the nipple and parallel to the torso); Upper Back - Oriented roughly parallel to the spine with the top of the device about 1 cm below the shoulder blade and the side of the device about 1 cm to the side of the spine such that none of the electrodes are directly over the spine; Lower Back - Oriented parallel to the spine with the bottom of the device about 1 cm above the waist line and
  • each electrode configuration is composed of a pair of conductive elements 20 (current elements) to direct an alternating current through the body, and a pair of conductive elements 20 (voltage elements) to measure the voltage across them.
  • the table below shows some of the exemplary electrode configurations (with reference to FIG. 10A) that may be used in a measurement. These configurations are described in further detail and referred to below.
  • conductive elements 20a and 20f may be used to apply an alternating current through the body and conductive elements 20b and 20e may be used to measure the differential voltage across them.
  • any pair of current elements may combine with another pair of voltage elements to form a configuration.
  • each current element (20a, 20f, 20g, 20h, etc.) of a configuration may be wider than each voltage element (20b, 20e, 20i, 20k, etc.) of the configuration.
  • each voltage element pair of a configuration may be positioned radially inwards of the current element pair of the configuration (20a, 20f).
  • the alternating current directed through a current element pair is typically between about 5 micro-amps and about 500 micro-amps at a frequency between about 1 kHz and about 1 MHz, and the voltage measured across each voltage element pair is typically between about 500 microvolts and 50 millivolts.
  • the device when device 10 is used to take a measurement of a region, the device may take voltage measurements using multiple different configurations of electrodes 18 at multiple frequencies. That is, in some embodiments, in a single measurement, the device 10 may take voltage measurements using the above-described configurations 1, 2, 3, and 4 at different frequencies of current (e.g., 25 KHz, 50KHz, 100 KHz, 200 KHz, etc.) before indicating that the measurement is complete. In some embodiments, the device 10 may take measurements of some (but not all) of the configurations (e.g., configurations 1 and 2). In some embodiments, the device 10 may take measurements in only one configuration (e.g., configuration 1) before indicating that the measurement is complete. In some embodiments, the number of configurations to use may be selected before a measurement is initiated. The measurements in the multiple configurations may be taken simultaneously or sequentially.
  • the device 10 may take voltage measurements using multiple different configurations of electrodes 18 at multiple frequencies. That is, in some embodiments, in a single measurement, the device 10 may take voltage
  • the purpose of using multiple electrode configurations is that, depending on the distances and orientations between the conductive elements 20, a particular configuration may yield bioimpedance parameters that correlate better with physiological characteristics of interest.
  • the distance between conductive elements 20a and 20b (and conductive elements 20f and 20e) is about 0.3 inches (7.62 mm) and the distance between conductive elements 20a and 20j (and conductive elements 20f and 201) is about 1.17 inches (29.72 mm). It has been observed that bioimpedence measurements using a configuration (such as configuration 1) in which the voltage elements (such as electrodes 20b and 20e) are closer to the current elements (such as 20a and 20f) correlate strongly with subcutaneous skin fat thickness.
  • placing the voltage electrodes farther from the current electrodes results in measurements of bioimpedance that are less sensitive to subcutaneous fat and more sensitive to muscle quality, fatigue, recovery, health, and fitness.
  • an exemplary measurement of parameters 35 related to bioimpedance of a biceps using device 10 is described below.
  • the four electrode configurations listed in Table 1 above i.e., configurations 1, 2, 3, and 4
  • the four current frequencies used may include 25 KHz, 50KHz, 100 KHz, and 200 KHz, respectively.
  • these frequencies are exemplary and that any suitable magnitude and number of frequencies may be used with any electrode configuration.
  • the device 10 may be positioned on the bicep of the user with the electrodes 18 in contact with the skin of the bicep.
  • the light ring 16 (or the display 52 of the associated device 37) may indicate when good contact is made with the skin. Measurement may then be initiated by depressing a button 14 (or using device 37).
  • the device 10 may measure bioimpedance data (e.g., impedance, resistance, phase angle, etc.) using the four electrode
  • these health parameters 35 may include parameters related to the percentage of fat and muscle at the measured location (biceps in this example) and parameters related to overall muscle quality at that location. In some embodiments, these parameters may include simple biceps fat percentage, biceps fat percentage, biceps muscle percentage, biceps muscle quality, modified biceps muscle quality, biceps muscle fatigue, and biceps strength workout zone. These health parameters 35 may be determined as a function of the measured data (resistance, phase angle, etc.) at some or all of the frequencies at some or all of the electrode configurations.
  • the parameters related to fat percentage may be calculated as a function of the measured resistance at multiple current frequencies using the same electrode configuration
  • the parameters related to muscle percentage such as, bicep muscle percentage
  • the parameters related to muscle quality may be calculated as a function of the ratio of the muscle percentage to the fat percentage.
  • muscle quality may not be calculated as a ratio of muscle percentage to fat percentage. Instead, muscle quality may be calculated directly from measured impedance values.
  • simple biceps fat percentage, biceps fat percentage, biceps muscle percentage, biceps muscle quality, and modified biceps muscle quality may be measured using the equations presented below.
  • Simple Biceps Fat Percentage 0.35/ohms x ( ⁇ Biceps resistance at configuration 1 at 50 kHz ⁇ + ⁇ Biceps Resistance at configuration 1 at 100 kHz ⁇ + ⁇ Biceps Resistance at configuration 1 at 200 kHz ⁇ );
  • the Bicep Muscle Quality may then be determined as 100 x tanh (Biceps Muscle Percentage / Biceps Fat Percentage / 4.5), and modified Biceps Muscle Quality may be computed as Biceps Muscle Quality + 2.1 x Gender + 0.1 x weight/height 2 using 1 for males and 0 for females for the constant "Gender.”
  • fat percentage and MQ may be calculated using the equations below.
  • Fat Percentage R50C1 - 7;
  • MQ M(kl*P100Cl A 2 + k2*P50C3 A 2 + (k3/R25Cl) A 2 + (k4/R50Cl) A 2 + (k5/R100Cl) A 2 + (k6/R200Cl) A 2) A 0.5+N.
  • PlOOCl for example, means phase at 100kHz using configuration 1
  • P50C3 means phase at 50kHz using configuration 3
  • R25C1 means resistance at 25kHz using configuration 1
  • R50C1 means resistance at 50 kHz using configuration 1
  • R100C1 means resistance at 100 kHz using configuration 1
  • R200C1 means resistance at 200 kHz using configuration 1, etc.
  • additional health parameters 35 also may be calculated using the measured data. These health parameters may include parameters related to muscle status and muscle fatigue. In some embodiments, these parameters may be calculated using the formulas presented below (for biceps).
  • Biceps Muscle Fatigue Biceps Muscle Status at baseline - Biceps Muscle Status at current time;
  • Biceps Muscle Fatigue as Percentage (Biceps Muscle Status at baseline - Biceps Muscle Status at current time)/(Biceps Muscle Status at baseline) x 100%. In these formulas, 1 is used for males and 0 for females for the constant "Gender.”
  • Biceps Strength Workout Zone may be calculated based on the description below:
  • the device 10 then may be moved to other locations on the body (such as, the stomach, quadriceps, scapula, etc.) and the measurements repeated in those localized regions.
  • health parameters 35 for a location may be calculated using the above-described formulas using the measured data at the location.
  • whole body parameters such as Total Body Fat Percentage, Total Body Muscle Percentage, and Total Body Muscle Quality may be computed in any suitable manner.
  • characteristics may be calculated based upon the various localized measurements and/or localized health parameters 35 based on those measurements.
  • the total body characteristics may be calculated by performing a suitable statistical calculation, e.g., taking the average, weighted average, mean, median, standard deviation, liner regression, etc. of health parameters 35 calculated from the local measurements.
  • 1 and 0 may be used for males and females, respectively, for the constant Gender. Height may be measured in meters, and weight may be measured in kilograms.
  • the example above illustrates how device 10 may be used to compute health-related parameters based on the measured data. Without intending to be limiting or to suggest that "Muscle Quality” may not be further refined, “Muscle Quality” is a figure of merit for muscle capability. The higher the “Muscle Quality,” the more capable is the muscle being measured. Also, without intending to be limiting or to suggest that "Muscle Fatigue” may not be further refined, “Muscle Fatigue” is a measure of a muscle's reduced capacity to exert force.
  • Total body fat (and/or other total body health parameters such as total muscle percentage, total MQ, etc.) may be obtained using several methods.
  • the total body fat may be obtained by combining the readings obtained from measurements of multiple individual body regions or muscles. That is, the fat percentage of multiple individual body regions and/or muscles (e.g., triceps, abs, quadriceps, etc.) is first obtained and then the data is combined to obtain the total body fat.
  • the individual data may be combined in any manner (e.g., average, weighted average, nonlinear equations, etc.).
  • the total body fat is calculated directly using impedance values measured from individual body regions and/or muscles.
  • total body fat bO + bl* ⁇ triceps resistance @ 200 kHz using configuration 1 ⁇ + b2* ⁇ abs resistance @ 200 kHz using configuration 1 ⁇ + b3* ⁇ quads resistance @ 200 kHz using configuration 1 ⁇ + b4* ⁇ abs resistance @ 200k using configuration 1 ⁇ * ⁇ quads resistance @ 100 kHz using configuration 2 ⁇ .
  • the total body fat calculated using any of the above described methods may be combined with demographic information such as gender, age, weight, or height.
  • Device 10 may include electronic devices and circuitry configured to measure and compute the above-described parameters 35.
  • FIG. 12 illustrates an exemplary circuit 60 included in device 10.
  • Circuit 60 may include a microprocessor 62 with digital signal processing (DSP) capability, multiplexers (MUX) 64, amplifiers 66, and other electronic devices adapted to acquire the data and perform the computations to determine the parameters 35.
  • DSP digital signal processing
  • MUX multiplexers
  • Other exemplary circuits that may be included in device 10 are described in U.S. Patent Nos. 8,892, 198 and 9, 1 13,808, and U.S. Provisional Patent Application Nos. 61/869,757 and 61/916,635, each of which are incorporated herein in their entirety by reference.
  • Several exemplary embodiments of device 10 and methods of using the device are described below.
  • the electrical signal applied across a pair of current elements is digitally generated in the microprocessor 62 by adding sinusoidal signals of different amplitudes and frequencies.
  • the digital signal is converted into an analog voltage signal using a digital-to-analog converter (DAC) and then filtered using a bandpass filter (BPF).
  • An analog multiplexer (MUX) 64 is used to apply the signal to one of multiple electrodes 18.
  • a transimpedance amplifier (TIA) 66 via a separate multiplexer 64.
  • the TIA 66 accurately measures the current.
  • the differential voltages generated on the surface of the skin are measured using an instrumentation amplifier (IAMP) 66 that is attached to two electrodes 18 via a differential multiplexer 64.
  • the multiplexer 64 allows the IAMP 66 to be connected to multiple sets of voltage-sensing electrodes 18.
  • the microprocessor 62 has additional amplifiers that are used to amplify the outputs of the TIA 66 and IAMP 66. Impedance calculations are then performed by the microprocessor 62 using a lock-in architecture, using methods well known to a person of ordinary skill in the art as is described in the literature. The following example illustrates how information from the user's profile and the measuring conditions may be used to measure data and compute parameters 35 by the device 10.
  • Data similar to bicep data described above may be measured at different locations of the body and the fat and muscle percentages at these locations may be calculated (using the equations described previously) as
  • the measured data and/or the computed parameters 35 may be displayed on display 12 of device 10.
  • the data and/or the computed parameters 35 may be wirelessly transmitted from device 10 to the associated device 37.
  • any wireless communication technology e.g., Bluetooth, low power Bluetooth, Wi Fi, ZigBee, etc.
  • the information may be transferred to device 37 by an optical method of transmission (e.g., using visible radiation or infrared radiation), an ultrasound signal, or a wired connection.
  • the system may include an apparatus of some type (housing, flexible substrate, etc.) to support the electrodes, a power supply and electronics to supply and measure the current, a voltage measuring system to measure the voltage resulting from the current, analytical capability to analyze the current and resulting voltage, display capability to display the calculated parameters (such as fat percentage, muscle percentage and muscle quality), and optionally data transmission capability to transmit either raw data or analyzed results to a remote data storage and/or analysis station.
  • the apparatus may be a single integrated unit or may comprise multiple components. Without intending to be limiting, several embodiments and arrangements of the apparatus and components of the apparatus are described below.
  • electrodes 18 may be incorporated into a housing 1 16.
  • the housing 1 16 may also include (e.g., enclose) electronics to control the electrodes 18. These electronics may include circuitry to supply current to the current electrode pairs and measure the voltage across the voltage electrode pairs.
  • the electronics may also include circuits (e.g., transceiver circuits) to transmit data to an associated device 137 (e.g., a synced cellphone, computer, exercise machine, etc.) and receive instructions (e.g., to initiate measurement, select electrode pairs, configure the electronics, etc.) from the associated device 137.
  • an associated device 137 e.g., a synced cellphone, computer, exercise machine, etc.
  • receive instructions e.g., to initiate measurement, select electrode pairs, configure the electronics, etc.
  • the electronics may also include circuits configured to perform calculations on the measured data and obtain the parameters 35 from the measured data.
  • Housing 116 may be affixed to (attached, adhered, snapped into, stitched on, using a Velcro® like attachment method, etc.) a supporting apparatus 120 (band, belt, strap, lanyard, etc.) or garment (shirt, shorts, cap, etc.) that may be worn or carried by a user. It is also contemplated that, in some embodiments, the housing 116 may be a free-standing component (i.e., not attached to a supporting apparatus 120).
  • the user may position the supporting apparatus 120 (e.g., attach the band, wear the garment, etc.) such that the electrodes 18 are in intimate contact with the skin of the user.
  • the housing 1 16 is a free-standing component
  • the user may merely press the electrodes 18 against the skin at the desired location to make intimate contact with the skin.
  • the associated device 137 may then initiate a measurement at the location by triggering the electronics in housing 1 16 to provide current to the current electrode pairs of the electrodes 18, and measure the data (e.g., voltage) across the voltage electrode pairs.
  • a button (not shown) provided on housing 1 16 may be pressed to initiate the measurements.
  • the electronics in housing 1 16 may also and calculate the parameters 35 using the measured data (e.g., by using the previously described equations). The computed parameters 35 may then be transmitted to the associated device 137 or a remote computer system for display and/or storage. Any known wireless or wired communication technology can be used for the transmission. In some embodiments, the electronics in the housing 1 16 may transmit the measured raw data to the associated device 137, and the associated device 137 may perform the calculations. The housing 1 16 may now be repositioned to a different location (e.g., over another muscle) and the measurements repeated. In some embodiments, the housing 1 16 may be configured to be removed from one location and attached to a new location of the user's body to make measurements at the new location.
  • the housing 1 16 may be attached to the user's skin or clothing using a separable attachment mechanism (e.g., elastic band, belt like strap, gel, clip, adhesive strip, Velcro ® like attachment mechanism, etc.) that may be removed from one location and repositioned to another location.
  • a device 220 may include electrodes 18 patterned on a flexible substrate 216 (e.g., a sticker-like strip).
  • FIG. 14A illustrates a top view of the substrate 216 and FIG. 14B illustrates a cross- sectional view.
  • the substrate 216 may include patterned circuits (e.g., conductive traces 222, plated through holes 224, and other known conductive elements) that electrically connect the electrodes 18 on one side of the substrate 216 to electrical contacts or pads 218 on the opposite side of the substrate 216.
  • patterned flexible substrates 216 may be made using any known material (e.g., polyimide, polyester, etc.) used for such purposes using any suitable process known in the art (e.g., lamination, deposition, masking, etching, etc.).
  • the device 220 may be self-contained in that the flexible substrate 216 includes the necessary circuitry (power supply, transceiver, etc.) to make a measurement and transmit data to a linked associated device (of any type described previously).
  • a separate module that includes a power supply and the required electronics may couple with the device 220 to make measurements.
  • FIG. 14C illustrates an exemplary method of using a device 220 of the type described with reference to FIGS. 14A and 14B.
  • the device 220 may be attached to the user's skin at the desired location such that the electrodes 18 are in contact with the skin.
  • multiple devices 220 may be attached at several desired locations (e.g., over multiple muscles) on the user.
  • the device 220 may be attached to the skin by any method (e.g., using a gel, glue, tape, etc.).
  • the substrate 216 may include an adhesive layer over the electrodes 18 that is covered using a protective strip.
  • the user may peel off the protective strip and attach the substrate 216 at the desired location with the electrodes 18 in contact with the skin.
  • a gel layer may also be provided under the protective strip to enhance electrical contact between the electrodes and the user's skin.
  • the associated device may wirelessly initiate a measurement by sending a signal to the one or more devices 220 attached to the user.
  • the device 220 may make a measurement and send the measured data to the associated device.
  • the associated device may calculate the parameters 35 using the data and present results on its display. It is also contemplated that, in some embodiments, the device 220 may perform some or all of the calculations and transmit the results to the associated device.
  • a separate module 230 that includes a power supply (battery) and the electronics (needed to make a measurement), may be electrically coupled to the device 220 to make a measurement.
  • the module 230 may be electrically coupled to a device 220 in any manner.
  • the module 230 may include electrical contacts that align and mate with the pads 218 on the flexible substrate 216 of the device 220.
  • the module 230 may be attached to a device 220 such that the contacts on the module 230 mate with the corresponding contacts on the device 220 (see device 220C of FIG. 14C).
  • the module 230 may be attached to the device 220C in any manner.
  • the top surface of the device 220 may also include an adhesive layer (similar to the adhesive layer over the electrodes 18) covered by a peelable strip of material, and the module 230 may be attached to the device 230C using this adhesive layer.
  • this attachment method is only exemplary and other attachment methods (such as, a clip, band, or a Velcro® like attachment mechanism) may be used to attach the module 230 to the device 230C.
  • the module 230 may supply power to the electrodes 18, acquire data, and compute results. The results may then be transmitted to the associated device for display. In some embodiments, the raw data may be transmitted to the associated device for calculations and display of results.
  • the module 230 may be connected to the devices 220 using wires, and the module 230 may trigger and make a measurement as discussed above. It is also contemplated that, in some embodiments, the module 230 may be wirelessly coupled to the devices 220. In some embodiments, as illustrated in FIG. 14C, the module 230 may be directly mounted on one device 220 attached to the user (e.g., device 220C), and connected to the other devices (e.g., device 220A, 220B) using wires.
  • the module 230 may be carried by the user (e.g., hooked to a belt, in a pocket, etc.) and coupled to the one or more devices 220 using wires.
  • the module 230 may make take measurements of all the devices 220 attached to the user simultaneously (i.e., devices 220A, 220B, and 220C measured at the same time) or sequentially (i.e., devices 220A first, 220B second, and 220C third, etc.)
  • FIG. 15 illustrates another embodiment of the disclosed device.
  • one or more devices 320 may be incorporated into a garment worn by the user.
  • an electrode array (similar to those discussed previously) and associated circuitry may be stitched or weaved into the garment at desired locations.
  • the electrodes may be woven into the fabric on a garment such as a shirt, shorts, pants, socks, etc. and connected to electronics that perform the measurements.
  • the electrodes also may be configured for placement into prefabricated "pockets" in the garment. These locations may correspond to the location of the desired muscles groups in the body. When worn by the user, the electrodes of the device 320 may snugly contact the skin of the user.
  • the garment may include any tight fitting clothing.
  • a module (similar to module 230 of FIG. 14C) may electrically couple with the one or more devices 320 in the garment to control the devices 320, make a measurement, and transfer results to an associated device 37.
  • the module may electrically couple with and make a measurement using any of the methods described with reference to the embodiment of FIGS. 14A-14C.
  • the module may be eliminated and the associated device 37 may be used to control the devices 320.
  • the electrodes 18 may be incorporated into the body of a portable music player (e.g., Apple IPod ® ) or a cellphone 810 (e.g., Apple iPhone ® , Samsung Galaxy ® , etc.), and an application may be used to control the measurement of the data and calculate parameters 35 based on the measured data.
  • a portable music player e.g., Apple IPod ®
  • a cellphone 810 e.g., Apple iPhone ® , Samsung Galaxy ® , etc.
  • an application may be used to control the measurement of the data and calculate parameters 35 based on the measured data.
  • the cellphone 810 may be powered by its internal power supply (such as a battery), or a separate power supply.
  • a software application (or app) on the cellphone may be used together with the computational capability of the cellphone to control the supply and measurement of current.
  • hardware-based or software-based voltage measuring capability may be built into the cellphone 810 and the application may be used to analyze the measured voltage and current, and perform calculations.
  • This application can either be the same application used to control the supply of current or a different application.
  • the display of the cellphone 810 may be used to display the measured data and the computed parameters 35.
  • the data transmission capability of the cellphone 810 may be used to transmit the measured data and/or analysis results to a remote station for data storage and/or analysis.
  • the cellphone's mobile communication network may be used for this transmission and in other embodiments, any of the previously described wireless communication mechanisms may be used.
  • the electrodes 18 may be incorporated into a case 830 which is used to hold and/or protect a cellphone 810 or a portable music player.
  • the cellphone 810 may be configured to fit into (slip, slide, fastened, etc.) the case 830.
  • electrical contacts on the case connected to the electrodes 18
  • corresponding contacts on the cellphone 810 make contact to establish an electric connection.
  • information data, instructions, signals, etc. may be transferred between the cellphone 810 and the case 830 wirelessly (e.g., using known communication technology).
  • the power supply that provides power to the electrodes 18 may be a separate power supply in the case 830 or may be the power supply of the cellphone 810.
  • Computational capability may be built into the case 830 (or may be incorporated in a cellphone application) to control the current delivery.
  • Voltage and current measuring capability may be built into the case 830 and/or the cellphone 810.
  • the user may activate an electrical connection between the case 830 and the cellphone 810 (for instance, by inserting a wire connecting them, by activating a switch, etc.) when desired.
  • This electrical connection between the case 830 and the cellphone 810 may then be used to transfer electrical power, data, information, or signals between the two.
  • An application on the cellphone 810 may be used to analyze current and voltage and compute the parameters 35.
  • the display of the cellphone 810 may be used to display the data or a separate display (an external display, etc.) may be used.
  • the mobile communication capability of the cellphone 810, or any wireless communication capability may be used to transmit the data and parameters 35 to a remote station for data storage and analysis.
  • the electrodes 18 may be housed in a module 820 separate from the cellphone 810 and the case 830 as shown in FIG. 16B.
  • the module 820 may be positioned such that its electrodes are kept in contact with skin.
  • the module 820 may be attached to the user using a strap or an elastic band. However, any attachment mechanism may be used to attach the module 820 to the user.
  • the module 820 may transmit the measured data and/or analysis results to the phone 830.
  • wires may connect the module 820 to the phone 810.
  • the module 820 may include memory to store the measured data. After measurements are taken at one or more locations of the user's body, the stored data may be transferred from the module 820 to the phone 810. Data may be transferred wirelessly or through a wired connection.
  • Data may be transferred wirelessly or through a wired connection.
  • the user may establish a connection between the phone 810 and the module 820 (e.g., by connecting a wire between them).
  • the wired connection may be removable at both ends or may be permanently attached to the electrode apparatus.
  • Power may be provided to the module 820 and to the electrodes 18 from the phone 810 using this connection or using a separate power supply in the module 820. Similar to the embodiments discussed above, the cellphone 810 may perform the necessary
  • data may be transferred between the module 820 and the phone 810 (or another associated device) by inserting the module 820 (or a connector attached to the module 820) to a cavity or a port (USB port, Lightning connector port, etc.) in the phone 810.
  • data may be transferred from the module 820 to the case 830 using any of the methods described above.
  • a separate power supply may be provided in the module 820.
  • the phone 810 or the case 830 may provide power to the module 820 and computational capability may be provided by a cellphone app.
  • current and voltage measuring capability may be built into the cellphone case 830 and data may be transmitted from the module 820 to the cellphone 810.
  • a cellphone app may be used to analyze current and voltage and perform calculations, and the display of the cellphone 810 may be used to display the data.
  • data and/or results may be transmitted from the phone 810 to a remote computer for data storage and/or analysis.
  • the mobile communication network or wireless capability of the cellphone 810 may be used for the transmission.
  • the module 820 may directly transfer the measured data (wirelessly or through a wired connection) to a remote station (such as, computer system 40 of FIG. 1) where it is stored and/or analyzed.
  • a smartphone based device as described with reference to FIGS. 16A and 16B is used to make the measurements described below.
  • This device includes at least three parts - the smartphone 810; module 820 with the electrodes 18 in contact with the tissue; and a case 830 or holder which holds the module 820 and snaps or fastens securely onto the smartphone 810.
  • There is a hole 840 in the case 830 which allows the electrodes 18 on the module 820 to come into direct contact with the tissue.
  • the module 820 is located between the smartphone 810 and the case 830 and is held securely in place by the case. There may be locating pins or another similar mechanism on the module 820 and the case 830 to ensure that the electrodes 18 are properly oriented (e.g., along the axis of the smartphone 810 or in some other desired orientation).
  • This arrangement allows a single design of module 820 to be used with a number of designs of smartphones 810.
  • the module 820 can communicate with the smartphone 810 by wire, wireless or direct plug in communication.
  • the module 820 can be powered by the smartphone 810 or internally powered.
  • a single (or a small number) of module designs may enable the use of the module 820 with essentially any design of smartphone or corresponding case.
  • FIG. 17 is a graph showing the computed MQ results and FIG. 18 is a table of these results.
  • the subject's MQ was stable during the baseline measurements, then spiked sharply during the sets of biceps curls, and then dropped significantly below baseline reaching a minimum value of 72 approximately 20 minutes after the final set. The MQ then rose slowly above the baseline value and then slowly came back down to approximately the same value seen at baseline.
  • impedance values such as resistance, phase, or reactance at one or more frequencies and one or more configurations can be used to calculate muscle fatigue.
  • the resistance at 50 kHz for configuration 1 can be monitored in a similar fashion as described above in place of MQ.
  • an exercise program may be designed by a physical therapist, personal trainer or other appropriately skilled person.
  • the information from the measurements may be used in designing the exercise program.
  • the user carries out the exercise program and, at appropriate times and intervals, the fatigue and/or recovery is measured. For example, the measurements might be once per week, once every two weeks or at other appropriate intervals.
  • the change in fatigue and/or recovery measurements may be noted and the exercise program may be continued or modified as appropriate to enhance muscle improvement, muscle capability retention or minimize muscle deterioration.
  • P100C1 for example, means phase at 100kHz using configuration 1
  • P50C3 means phase at 50kHz using configuration 3
  • R25C1 means resistance at 25kHz using configuration 1
  • R50C1 means resistance at 50 kHz using configuration 1
  • RlOOCl means resistance at 100 kHz using configuration 1
  • R200C1 means resistance at 200 kHz using configuration 1.
  • electrode separation is the distance between two electrodes of electrodes 18, for example, electrode 20a and electrode 20e in FIG. 10A.
  • Set of electrode separations refers to the separation of the electrodes in a configuration.
  • the set of electrode separations would be the separation between electrode 20a and electrode 20e (the current electrodes) and the separation between electrode 20b and electrode 20f (the voltage electrodes).
  • a plurality of sets of electrode separations refers to two or more sets of electrode separations. For example, this could be the set of electrode separations of configuration 1 and the set of electrode separations of configuration 3.
  • the calculations use information taken using a plurality of sets of electrode separations, namely configuration 1 and configuration 3.
  • Test protocol refers to the conditions involved in making one or more measurements including device position(s), test frequencies, electrode arrangement, electrode separations, configurations used and other test parameters.
  • Device position refers to the location in which the device is positioned on the tissue with the electrodes in contact with the tissue.
  • Single device position indicates that the device is positioned on the tissue and not moved.
  • Measurements made during a single device position refers to the measurements made during a single device position during which the device and electrodes are not moved or realigned. As explained previously, these measurements may involve measurements from multiple electrodes or multiple configurations.
  • FIG. 19 presents the data from measurements discussed above.
  • values are given for total body MQ and total body fat percentage.
  • Total body fat percentage average of body fat percentage of biceps, triceps, quadriceps, and abdominals.
  • measured data of individual body regions may be combined in any manner (e.g., average, weighted average, nonlinear equations, etc.) to get the total body health parameters.
  • the device 10 and/or 37 may have the capability for audio output or for audio input.
  • Audio output may include, for example, audio output of data, training information, etc., audio repetition of textually displayed information, or audio information synched with displayed video, etc.
  • Audio input may include various commands used to control the device 10 and/or 37. That is, device 10 and/or 37 may be activated and/or controlled by audio commands. In some embodiments, device 10 and/or 37 may turn itself off to save power after a predetermined period of inactivity.
  • This predetermined time may be a preprogrammed value that may be changed by the user.
  • a timer for automatically turning off may be reset.
  • the electrodes 18 may be moistened (i.e., pre-moistened) before being placed in contact with skin to improve contact of the electrodes 18 with the skin.
  • this pre-moistening may not be needed since sufficient electrical contact may be achieved without pre-moistening.
  • Pre- moistening may be achieved by a spray, cloth, a wipe, or any other method which provides sufficient moisture.

Abstract

La présente invention concerne un dispositif portable pour mesurer une propriété liée à la bio-impédance d'un tissu qui comprend une pluralité d'électrodes agencées dans un motif sur une surface et un logiciel associé pour mesurer des données liées à la bio-impédance de régions localisées de tissu et calculer des paramètres liés à la santé sur la base des données mesurées. Ces paramètres calculés peuvent être représentatifs de la santé musculaire de la région de tissu localisée.
PCT/US2015/062375 2014-11-24 2015-11-24 Systèmes et procédés de mesure de bio-impédance WO2016099824A1 (fr)

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