WO2015031278A1

WO2015031278A1 - Devices and methods for measuring bioimpedance-related properties of body tissue and displaying fat and muscle percentages and muscle quality of bodies and body regions

Info

Publication number: WO2015031278A1
Application number: PCT/US2014/052563
Authority: WO
Inventors: Jose L. Bohorquez; Juan Jaramillo; Gonzalo CESPEDES; Yensy HALL; Stanislava DARASHKEVICH; Elmer C. Lupton; Seward RUTKOVE
Original assignee: Skulpt, Inc.
Priority date: 2013-08-25
Filing date: 2014-08-25
Publication date: 2015-03-05
Also published as: JP2016533835A; AU2014311467A1; CA2922194A1; EP3038526A1

Abstract

A device, associated software, and associated methodology provide an instrument and method for measuring fat and muscle content, including simultaneous measurement, as well as muscular health and fitness, in localized body parts. The device can be wireless, portable, and handheld, can include a display for immediate feedback, and can be capable of measuring health and fitness related parameters on a plurality of body regions. Several arrangements are given for the devices.

Description

DEVICES AND METHODS FOR MEASURING BIOIMPEDANCE- RELATED PROPERTIES OF BODY TISSUE AND DISPLAYING FAT AND MUSCLE PERCENTAGES AND MUSCLE QUALITY OF BODIES AND

BODY REGIONS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application is entitled to the benefits of priority under 35 USC §§119-120 to U.S. Provisional Patent Applications Nos. 61/869,757, filed on August 25, 2013; 61/916,635, filed on December 16, 2013; 61/952,483, filed on March 13, 2014; and 62/012,192, filed on June 13, 2014, entireties of all of which are incorporated herein by reference.

GOVERNMENT LICENSE RIGHTS

[0002] This invention was made with US Government support under grants R43NS073188, R43NS070385, R44NS070385, R44AR064142, and R41AG047021 awarded by the National Institutes of Health and 1064826 awarded by the National Science Foundation. The government has certain rights in the Invention

FIELD OF THE DISCLOSURE

[0003] Embodiments of the present disclosure disclose systems and methods for measuring, tracking and/or managing the composition of individual body parts with specific interest in muscles. In some embodiments, the disclosed systems include a portable, hand-held device, and a disclosed method includes methods to assess health and fitness.

BACKGROUND

[0004] The benefit of measuring electrical impedance of tissue as a method of assessing the health of the tissue is known. See for example: U.S. Patent Application No. 13/823,659, J. Bohorquez et. al., "Device and methods for evaluating tissue," filed March 14, 2013, published as U.S. Patent Application Publication No. 2014/0039341; U.S. Patent Application No. 13/842,698, J. Bohorquez et. al.,

"Systems, Methods and Sensors for Measuring Tissue," filed March 15, 2013, published as U.S. Patent Application Publication No. 2013/0338473; U.S. Patent Application No. 11/992,430, Shiftman, et. al, "Electrical Impedance Myography," filed Sep. 21, 2006, published as U.S. Patent Application Publication No.

2010/0292603; and U.S. Patent Application No. 13/391,484, Rutkove S. and Dawson J., "Hand-held device for Electrical Impedance Myography," filed August 20, 2010, published as U.S. Patent Application Publication No. 2012/0245436, all of which are incorporated herein in their entirety by reference. These references discuss measurement of electrical impedance myography (EIM). Unlike standard

electrophysiological approaches to measuring tissue health, EIM is less directly dependent upon inherent electrical potential of muscle or nerve tissue. EIM is based on electrical bioimpedance of tissue. It measures the effect of tissue structure and properties on the flow of extremely small, non-intrusive amounts of electrical current. Unlike standard bioimpedance approaches, however, measurements can be performed over small areas of muscle. In EIM, electrical current, such as, e.g., high-frequency alternating current, may be applied to localized areas of muscle via electrodes (e.g., surface electrodes) and the consequent surface voltage patterns are analyzed.

Typically, the 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 also limit their use in EIM measurements of users who are mobile and/or engaged in exercise.

[0005] Sustained exercise, including aerobic and anaerobic activities such as running, cycling, weight lifting, can produce muscle fatigue. Following sustained exertion, 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. Thus, it may be desirable to perform EIM measurements during exercise using a portable device attached to the user.

SUMMARY OF THE DISCLOSURE

[0006] A system for measuring/tracking and/or managing the composition of individual body parts is disclosed. The system may include a portable, hand-held device that is used to quantify the percentage of fat and muscle in individual body parts, and may uses this information to infer health and fitness. The device may apply a multi-frequency electrical current signal to the body part using a plurality of electrodes configured at a plurality of angles and distances, and then may measure the resulting voltages using a plurality of electrodes configured at a plurality of angles and distances. Several similar methods for such measurements are described in detail in: U.S. Patent Application No. 13/823,659, J. Bohorquez et. al., "Device and methods for evaluating tissue," filed March 14, 2013, published as U.S. Patent Application Publication No. 2014/0039341 ; U.S. Patent Application No. 13/842,698, J. Bohorquez et. al., "Systems, Methods and Sensors for Measuring Tissue," filed March 15, 2013, published as U.S. Patent Application Publication No. 2013/0338473; U.S. Patent Application No. 11/992,430, Shiftman, et. al., "Electrical Impedance Myography," filed Sep. 21, 2006, published as U.S. Patent Application Publication No. 2010/0292603; and U.S. Patent Application No. 13/391,484, Rutkove S. and Dawson J., "Hand-held device for Electrical Impedance Myography," filed August 20, 2010, published as U.S. Patent Application Publication No. 2012/0245436, all of which are incorporated herein in their entirety by reference. A microprocessor within the device may calculate an estimate for the percentage of fat and muscle present in the underlying tissue. The device may also calculate an estimate of muscle quality, health and fitness using the measured signals along with additional information such as the age, gender, weight, height, race, and temperature of the person being tested. The resulting information may then displayed on the device screen. The user may be able to get information on a plurality of body regions such as the biceps, chest, abdomen, quadriceps, triceps, gastrocnemius, forearms, back muscles, and gluteus maximus. The raw data collected by the device, such as current, voltage, resistance, reactance, phase, and impedance at multiple frequencies and for multiple electrode configurations, may then sent wirelessly to an associated device, such as a personal computer, smart phone, or tablet, using standard wireless technology such as

Bluetooth, WiFi, Zigbee, or other similar methods. Calculated parameters, such as muscle percentage, fat percentage, muscle quality, muscle fitness, and muscles health, may also be transferred to an associated device. The associated device may then transfers some or all of these parameters to a central database (see FIG. 1). The user may then review results through an online web dashboard on a personal computer, smart phone, tablet, or similar device (see FIG. 3).

[0007] In another embodiment, 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. For example, in an experiment conducted with three healthy men between the ages of 30-35, parameters such as reactance and phase at 50 kHz increased in value slightly during exercise (5-15% increase compared to baseline), then dropped dramatically (20-50% reduction compared to baseline) within 30 minutes of exercise, and then returned gradually to values near baseline (within 10% of baseline) over the course of 8-48 hours. These measurements were gathered using a device (similar to the devices described in U.S. Patent Publication Nos.

2014/0039341 (Bohorquez et. al.), and 2013/0338473 (Bohorquez et. al), and U.S. Provisional Patent Applications and provisional patent applications 61/869,757 (Bohorquez et. al.) and 61/916,635 (Bohorquez et. al.) all of which are incorporated herein in their entirety by reference) which uses multiple electrode configurations and frequencies to obtain localized bioimpedance measurements. These results are both unexpected and important as they provide a simple, noninvasive way of measuring and tracking muscle fatigue and recovery.

[0008] The device disclosed here may be a standalone handheld device, an apparatus attached or linked to a mobile device such as a cellular phone or tablet, a small wearable device such as an armband, or a wearable garment such as a shirt, shorts, or pants.

[0009] The device may apply a multi-frequency electrical current signal to the body part using a plurality of electrodes configured at a plurality of angles and distances, and then may measure the resulting voltages using a plurality of electrodes configured at a plurality of angles and distances. Similar measurement methods are described in detail in: U.S. Patent Application 13/823,659, J. Bohorquez et. al., "Device and methods for evaluating tissue," filed March 14, 2013, published as U.S. Patent Application Publication No. 2014/0039341 ; U.S. Patent Application No.

13/842,698, J. Bohorquez et. al., "Systems, Methods and Sensors for Measuring Tissue," filed March 15, 2013, published as U.S. Patent Application Publication No. 2013/0338473; U.S. Patent Application No. 11/992,430, Shiffman, et. al., "Electrical Impedance Myography," filed Sep. 21, 2006, published as U.S. Patent Application Publication No. 2010/0292603; U.S. Patent Application No. 13/391,484, Rutkove S. and Dawson J., "Hand-held device for Electrical Impedance Myography," filed August 20, 2010, published as U.S. Patent Application Publication No. 2012/0245436; U.S. Provisional Patent Application No. 61/869,757 (Bohorquez et. al.); and U.S. Provisional Patent Application No. 61/916,635 (Bohorquez et. al.), all of which are incorporated herein in their entirety by reference.

[00010] A microprocessor within the device may calculate an estimate for muscle fatigue as an absolute value and as a percentage of baseline. The device may also calculate an estimate of fat percentage, muscle quality, health and fitness using the measured signals along with additional information such as the age, gender, weight, height, race, and temperature of the person being tested. The resulting information may then be displayed on the device screen, on the screen of a linked device such as a mobile phone or tablet, or through other indicators such as LEDs or color-changing fabrics. The user may be able to get information on a plurality of body regions such as the biceps, chest, abdomen, quadriceps, triceps, gastrocnemius, forearms, back muscles, and gluteus maximus. The raw data collected by the device, such as current, voltage, resistance, reactance, phase, and impedance at multiple frequencies and for multiple electrode configurations, may then be sent wirelessly to an associated device, such as a personal computer, smart phone, or tablet, using a wireless standard such as Bluetooth, WiFi, Zigbee, or similar. Calculated parameters, such as muscle fatigue, muscle recovery, muscle percentage, fat percentage, muscle quality, muscle fitness, and muscles health, may also be transferred to an associated device. The associated device may then transfer some or all of these parameters to a central database (see FIG. 1). The user can then review results through an online web dashboard on a personal computer, smart phone, or tablet (see FIG. 3).

BRIEF DESCRIPTION OF THE FIGURES

[00011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the present disclosure and together with the description, serve to explain the principles of the disclosure.

[00012] FIG. 1 illustrates an overview of the system including the device.

[00013] FIG. 2 illustrates several views of the device of FIG. 1.

[00014] FIG. 3 illustrates how data stored in the system can be reviewed using any associated device.

[00015] FIG. 4 illustrates the multiple electrodes on a skin contacting side of the device of FIG. 2.

[00016] FIG. 5 illustrates the device of FIG. 2 being used to take measurements on a muscle, such as, e.g., the bicep of a user.

[00017] FIG. 6 is a schematic illustration of the electronic circuitry of the device of FIG. 2.

[00018] FIG. 7 is a plot of the measured Muscle Quality (MQ) of a user as a function of time.

[00019] FIG. 8 A illustrates a smartphone, electrode assembly and case

[00020] FIG. 8B illustrates an exploded view of a smartphone, electrode assembly and case.

DETAILED DESCRIPTION OF THE DISCLOSURE

[00021] 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 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. In some embodiments, device 10 may have a length and width between about 2-6 inches. In some embodiments, device 10 may have a width of about 2.5 inches and a length of about 3.5 inches. Device 10 may be configured to be attached (for example, strapped) to a user (for example, at the bicep) during exercise. For example, in some embodiments, 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.

[00022] FIG. 2 illustrates several views of the device 10. In the description that follows, reference will be made to both FIGS. 1 and 2. Device 10 may include one or more buttons 14 to navigate and control the device 10 (e.g., initiate measurements, etc.). In general, 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. 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 positioned on a front side 6 (or 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.

[00023] Device 12 may include a plurality of electrodes 18 to measure to measure data associated with bioimpedance of a user. In general, these electrodes 18 may be positioned at any location on the device 10. In some embodiments, the electrodes 18 may be positioned on the side opposite front side 6. That is the electrodes 18 may be position on the back side 8 (or a non skin-contating side) of the device 10. Although the FIG. 2 illustrates the electrodes 18 as being positioned on a side opposite the display 12, this is not a requirement. For example, in some embodiments, the electrodes 18 maybe positioned alongside the display 12, or on a side adjacent to the display 12. In use, 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. In some embodiments, a measurement may be initiated by pressing a button 14 of device 10. 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. After the completion of a measurement, the device 10 may inform the user of the completion of the measurement. The device 10 may use any method to inform the user (for example, by emitting a sound, vibration, light, display changing color, etc.). In some embodiments, device 10 may include a light 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. For example, the light may be activated to indicate that all electrodes 18 have made good contact with the skin, etc. In some embodiments, a light ring 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. In some embodiments, device 10 may be designed to be splash proof or otherwise water resistant, and, in a preferred embodiment, is fully submersible and thus water-proof.

[00024] Although not illustrated in FIG. 2, the system may also include other components, such as detachable sensors that connect to one or more garments worn by the user. For example, the electrodes 18 may be located on a strap or a band that is wrapped around (or otherwise attached) to the user. These detachable sensors may connect to the device 10 and transfer the data measured by the sensors to the device 10.

[00025] The device 10 may measure data and display the measured data on display 12. In some embodiments, as will be described in more detail below, the device 10 may analyze the measured data and compute health parameters 35 related to the health of the user. The health parameters 35 may include metrics related to the user's physical heath (for example, 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 an associated device 37 such as a smart phone, tablet, smart watch, computer, etc.

Device 10 may send the parameters 35 to the associate device 37 by any method (over a wire, wirelessly, or transferred in a transferable storage medium, etc.). In some embodiments, the device 10 may wirelessly (using, for example, low power Bluetooth, WiFi, ZigBee, a dedicated wireless channel, optical transmission (using visible or infrared radiation, ultrasound signal, etc.) transmit the parameters 35 to the associated device 37. In a preferred embodiment, device 10 may use low energy Bluetooth to transfer the parameters 35 to the associated device 37. 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.

[00026] In some embodiments, the associated device 37 may transmit some or all of the parameters 35 to a computer system 40 for storage and/or further analysis (trend analysis, etc.). Any type of known computer (desktop, laptop, networked computers, server, etc.) may serve as computer system 40. In some embodiments, a plurality of networked computers may serve as 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 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

(microprocessor, math processing unit, etc.) and circuitry configured to perform the analysis. The analysis may include tracking the variation of the user's health parameters 35 over time, etc. In some embodiments, the results of the analysis performed by the computer system 40 may be transmitted to and displayed on display 12 of the device 10 A.

[00027] In a preferred embodiment of the disclosure, the device may use a Bluetooth Low Energy to transfer data to an associated device. Display technologies that may be used on the device include thin-film-transistor (TFT) liquid-crystal displays (LCD) or organic light-emitting diode (OLED) displays among others. In the preferred embodiment of the disclosure, an OLED display may be used, and he device may be internally powered by a rechargeable battery.

[00028] The device may be designed to be splash proof, and, in a preferred embodiment, is fully submersible. The device may have buttons used to navigate and control the device. In a preferred embodiment, there may be three buttons. The measurement of each muscle may take less than 2 seconds. In one embodiment, a light ring surrounding the device may be used to inform the user that good contact is made, that a measurement has been initiated, and that a measurement has been completed.

[00029] 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). In some embodiments, as illustrated in FIG. 3, a user may access the computer system 40 using an associated device 37 to view the parameters 35 (and/or other health related data). In addition to the database and software configured to perform analysis on the measured data, computer system 40 also may include software configured to control of the operation of the device 10. In some embodiments, some portions or all of the software may reside in the device 10. A user may use the software to operate the device 10 (e.g., set up a personal account, manage the account, setup and customize the device, etc.). 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. In some embodiments, 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.

[00030] The software associated with computer system 40 may also enable the user to view exercise videos and set motivational goals. The software also may be configured to enable sharing of the parameters 35 and other data with friends through social network sites to compare results. In some embodiments, the computer system 40 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. 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.). Using the measured health parameters 35 of a user, the system may customize exercise routines for the user to follow, and inform the user about maintenance of their health and fitness.

[00031 ] In some embodiments, during setup, the user may be asked to manually select each body part via display 12 (or another graphical interface) on the device 10, and to measure the corresponding muscle on their body. These measurements may be used as a baseline for subsequent measurements. In some embodiments, after the initial setup, the device 10 maybe trained to recognize individual muscles so that measurement can begin as soon as the electrodes 18 come in contact with the user's skin. In some embodiments, measurements taken on the device 10 may be automatically synched with the user's profile on computer system 40 so that real time parameters 35 may be accessible to the user. Although in the description above all the health parameters 35 are described as being computed in the device 10, this is only exemplary. In some embodiments, some or all of the health parameters 35 may be computed on the computer system 40. In some embodiments, computer system 40 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.).

[00032] FIG. 4 illustrates the electrodes 18 on the backside of the device 10. Electrodes 18 may include any electrically conductive material (e.g., copper, aluminum, silver, gold, etc.). In some embodiments, the electrodes 18 maybe coated with another material to impart desirable properties to the electrodes 18 (e.g., oxidation, wear, and/or corrosion resistance, etc.). In some embodiments, the electrodes 18 may protrude from the surface of the device 10 on which they are positioned, h some embodiments, the electrodes 18 maybe flush with, or recessed relative to, the surface. The electrodes 18 may include multiple conductive elements 20 arranged in a pattern. In general, the conductive elements 20 may be arranged in any pattern. In some embodiments, the conductive elements 20 may be arranged in a pattern about a central axis 22 of the device 10 that extends perpendicular to the surface on which the electrodes 16 are positioned. In some embodiments, 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 14. In some embodiments, 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.

[00033] In some embodiments, as illustrated in FIG. 4, four conductive elements (20i, 20j, 20k, 201) maybe arranged to form the four sides of an inner square. These four conducive elements may have substantially the same length. In some embodiments, 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. In some embodiments, 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. In some embodiments, 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.

[00034] In use, all the conductive elements 20 of the electrodes 18 are positioned in contact with a region of a user's body to make a measurement. The conductive elements 20 are arranged at different distances and orientations to each other to make measurements using multiple electrode configurations. Each electrode configuration is composed of a pair of conductive elements 20 to direct a current through the body (current elements), and a pair of conductive elements to measure the voltage across (voltage elements). For example, in one configuration (e.g., configuration 1), conductive elements 20a and 20f may be used to apply an alternating current through the body (that is, as current elements) and conductive elements 20b and 20e may be used to measure a differential voltage (that is, voltage elements). In this example, the four electrodes 20a, 20b, 20e, and 20f will constitute one electrode configuration.

[00035] In another configuration (e.g., configuration 2), electrodes 20a and 20f may constitute the current elements and electrodes 20j and 201 may constitute the voltage elements. In another configuration (e.g., configuration 3), conductive elements 20c and 20d may constitute the current elements, and conductive elements 20j and 201 may constitute the voltage elements. In yet another configuration (e.g., configuration 4), electrodes 20g and 20h may constitute the current elements and electrodes 20i and 20k may constitute the voltage elements. Similarly, any pair of current elements may combine with another pair of voltage elements to form a configuration. In some embodiments, 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. In some embodiments, each voltage element pair of a configuration (e.g., 20b, 20e of configuration 1) 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.

[00036] In some embodiments, when device 10 is used to take a measurement of a region, the device may take voltage measurements using multiple different configuration of electrodes 18 at multiple frequencies. That is, in some embodiments, in a single measurement, the device 10 may take voltage measurements using 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, he 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. [00037] The purpose for 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. For example, in the embodiment of electrodes 18 illustrated in FIG. 4, 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 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. In contrast, by placing voltage electrodes farther from current electrodes (for example, with conductive elements 20a and 2f as the current elements and conductive elements 20j and 201 as the voltage elements) results in measurements of bioimpedance that are less sensitive to subcutaneous fat and more sensitive to muscle quality, fatigue, recovery, health, and fitness.

[00038] Without intending to be limiting, an exemplary measurement of parameters 35 related to bioimpedance of a bicep using device 10 is described below. In this exemplary measurement, four electrode configurations and four discrete frequencies are used for the measurements. These electrode configurations may include: configuration 1 = current elements 20a, 20f and voltage elements 20b, 20e; configuration 2 = current elements 20a, 20f and voltage elements 20j and 201;

configuration 3 = current elements 20c, 20d and voltage elements 20j and 201; and configuration 4 = current elements 20g, 20h and voltage elements 20i and 20k. The four current frequencies used may include 25 KHz, 50KHz, 100 KHz, and 200 KHz, respectively. Those of ordinary skill will recognize that these frequencies are

exemplary and that any suitable frequency may be used with any electrode

configuration. As illustrated in FIG. 5, 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 may indicate when good contact is made with the skin. Measurement may then be initiated by depressing a button 14. The device 10 may measure bioimpedance data using the four electrode configurations at the four different frequencies. In a preferred embodiment, the electrodes may be oriented along an axis of the device case, more preferably along the long axis. In another embodiment, the electrodes are not oriented along an axis of the device case, but an orientation line or other orientation marker is printed or otherwise placed on the device case in line with the orientation of the electrodes to permit the user to know the orientation of the electrodes by looking at the case. In a preferred embodiment, the device may be positioned on the tissue of the subject over the muscle to be measured so the axis of the device case, more preferably the long axis and the electrodes which are oriented along the long axis, is located along the muscle fibers to be measured. By "roughly oriented, it is intended that the user positions the device so it is as close to the conditions specified below as can be achieved by eye and feel. We have found it is not necessary to make a careful positioning using a measuring device or other precise locator.

[00039] "Roughly oriented" for each of the following muscles and muscle groups shall mean:

Biceps - Oriented along arm bone.

Triceps - Oriented along arm bone (yes, between shoulder bone and elbow).

Abs -(or Waist) - Oriented in front of body roughly parallel to (an in some cases, laterally offset from) the backbone (the edge of the sensor is placed about 1cm to the left or right of the navel with the vertical center of the sensor aligned with the navel. The long part of the sensor is 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 parallel to the torso. For men, middle of sensor goes over nipple. For women, the bottom of the sensor should be about 1 cm above the nipple and the vertical axis of the sensor should be colinear with the nipple and parallel to the torso.

Upper Back - Oriented parallel to the spine, with the top of the sensor about 1 cm below the shoulder blade and the side of the sensor about 1 cm to the side of the spine such that none of the sensors are directly over the spine.

Lower Back - Oriented parallel to the spine, with the bottom of the sensor about 1 cm above the waist line and the side of the sensor about 1 cm to the side of the spine such that none of the sensors are directly over the spine.

Hamstrings - Oriented along a long leg bone, half way between the bend of the leg opposite the knee and the gluteal fold.

Calves (gastrocnemius) - Oriented along leg bone.

Glutes - Oriented parallel to the leg bone with the edge of the sensor about 2 cm from the intergluteal cleft

Calf - Oriented along leg bone

Hip - Oriented diagonally, about 2cm above the hipbone. The angle of the sensor should be about the same angle as the hipbone.

Thigh - Oriented along leg bone. [00040] Using the measured data, several health parameters 35 related to tissue health may be determined as a function of the measured bioimpedance at some or all of the frequencies measured using some or all of the different electrode configurations. For example, in some embodiments, parameters 35 such as simple muscle fat percentage, biceps fat percentage, biceps muscle percentage, biceps muscle quality, and modified biceps muscle quality may be measured as discussed below.

[00041] 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}); Biceps Fat Percentage = 100 x tanh( 0.0036 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})]; Biceps Muscle Percentage = 100 x tanh( 0.025 x {Biceps Phase at configuration 1 at 50 kHz} x ({Biceps Phase at configuration 3 at 50 kHz} / {Biceps Phase at configuration 4 at 50 kHz}). The Bicep Muscle Quality may then be determined as 100 x tanh (Biceps Muscle Percentage / Biceps Fat Percentage / 4.5), and substituting 1 and 0 for the constant "Gender," for males and females respectively, the modified Biceps Muscle Quality may be computed as Biceps Muscle Quality + 2.1 x Gender + 0.1 x weight/height .

[00042] In some embodiments, additional health parameters 35 also may be calculated as Biceps Muscle Status = 100 x tanh (Biceps Muscle Phase at 25 kHz using configuration 1 - Biceps Muscle Phase at 25 kHz using configuration 2);

Modified Biceps Muscle Status = Biceps Muscle Status + 2.1 x Gender + 0.1 x weight/height²; 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%.

[00043] The device 10 then may be moved to other locations on the body (such as, the stomach, quadriceps, scapula, etc.) and the measurements repeated. Using these measurements, heath parameters 35 similar to those discussed above may be calculated. Using the computed parameters 35 from different parts of the body, and information from the user's profile, parameters 35 such as Total Body Fat Percentage, Total Body Muscle Percentage, and Total Body Muscle Quality may be computed as: Total Body Fat Percentage = 0.19 x Biceps Fat Percentage + 0.30 x Abdominal Fat Percentage + 0. 28 x Quadriceps Fat Percentage + 0.23 x Scapula Fat Percentage + 1.5 x Gender - 0.02 x weight/height² + 0.05 x age; Total Body Muscle Percentage = 0.15 x Biceps Muscle Percentage + 0.25 x Abdominal Muscle Percentage + 0. 23 x Quadriceps Muscle Percentage + 0.15 x Scapula Muscle Percentage + 1.1 x Gender - 0.3 x weight/height + 0.03 x age; and Total Body Muscle Quality = 0.30 x (Biceps Muscle Quality + Abdominal Muscle Quality + Quadriceps Muscle Quality + Scapula Muscle Quality) - 3.2 x Gender - 0.2 x weight/height² + 0.09 x age.

[00044] In the equations above, 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. Without intending to be limiting, the example above illustrates how device 10 may compute the parameters of interest 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.

[00045] Device 10 may include electronic devices and circuitry configured to measure and compute the above-described parameters 35. FIG. 5 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. Other exemplary circuits that may be included in device 10 are described in U.S. Patent Publication Nos. 2014/0039341, 2013/0338473, and U.S. Provisional Patent Application Nos. 61/869,757, and

61/916,635, all of which are incorporated herein in their entirety by reference.

[00046] In an exemplary embodiment of circuit 60 (example 1), the electrical signal applied across a pair of current elements (or electrodes 18) 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. By applying this voltage signal to a muscle through an electrode 18, an electrical current is generated between that electrode and a second electrode connected to 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 demographic information from the user's profile and the measuring conditions may be used to measure data and compute parameters 35 by the device 10.

[00047] Demographic Information: Gender: male, Weight = 80 kgs, Height = 1.75 m, Age = 32.

[00048] Electrode Configurations: Configuration 1 = current elements 20a, 20f and voltage elements 20b, 20e; Configuration 2 = current elements 20a, 20f and voltage elements 20j and 201; Configuration 3 = current elements 20c, 20d and voltage elements 20j and 201; and configuration 4 = current elements 20g, 20h and voltage elements 20i and 20k.

[00049] Frequencies: Fl = 25 kHz; F2 = 50 kHz; F3 = 100 kHz; and F4 = 200 kHz

[00050] Bicep Data measured using device 10: Biceps Resistance at configuration 1 at 50 kHz = 18.5 Ohms; Biceps Resistance at configuration 1 at 100 kHz = 14 J Ohms; Biceps Resistance at configuration 1 at 200 kHz = 12.0 Ohms; Biceps Phase at configuration 1 at 50 kHz = 24.3 degrees; Biceps Phase at configuration 2 at 50 kHz = 18.6 degrees; Biceps Phase at configuration 3 at 50 kHz = 14.8 degrees; Biceps Phase at configuration 4 at 50 kHz = 12.1 degrees.

[00051 ] Using the measured data, the biceps fat percentage may be calculated as: Biceps fat percentage = .35/ohms * (18.5 ohms + 14.7 ohms + 12.0 ohms) = 15.8%. 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 relationships described previously) as Abdominal Fat Percentage = 29%; Quadriceps Fat Percentage = 20%; Scapula Fat Percentage = 22%; Abdominal Muscle Percentage = 49%; Quadriceps Muscle Percentage = 68%; Scapula Muscle Percentage = 42%; Abdominal Muscle Quality = 36; Quadriceps Muscle Quality = 65; Scapula Muscle Quality = 40.

[00052] These parameters are then used in the equations described previously to calculate the physiological measures of interest as follows: Simple Biceps Fat Percentage = 0.35 x (18.5 + 14.7 + 12.0) = 15.8% ; Biceps Fat Percentage = 100 x tanh (0.0036 x 18.5 + 14.7 + 12.0) = 16.1%; Biceps Muscle Percentage = 100 x tanh (0.025 x 24.3 x 14.8 / 12.1) = 63.1%; Biceps Muscle Quality = 100 x tanh (63.1 / 16.1 / 4.5) = 70.2; Modified Biceps Muscle Quality = 70.2 + 2.1 + 0.1 x (80/1.75²) = 74.9; Total Body Fat Percentage = 0.19 x 16.1 + 0.30 x 29 + 0.28 x 20+ 0.23 x 22 + 1.5 - 0.02 x (80 / 1.75²) + 0.05 x 32 = 25.0 %; Total Body Muscle Percentage = 0.15 x 63.1 + 0.25 x 49 + 0.23 x 68 + 0.15 x 42 + 1.1 - 0.3 x (80/1.75²) + 0.03 x 32 = 38.5 %; Total Body Muscle Quality = 0.30 x (70 +-36 + 65 + 40) - 3.2 - 0.2 x (80 / 1.75²) + 0.09 x 32 = 57.8. In some embodiments (example 2), the measured data and/or the computed parameters 35 maybe displayed on display 12 of device 10. In some embodiments, the data and/or the computed parameters 35 maybe wirelessly transmitted from device 10 to associated device 37. In one embodiment, the method of transmission is low power Bluetooth. In another embodiment, it is Wi Fi. In another embodiment, it is ZigBee. In another embodiment, it is a dedicated wireless signal. In another embodiment, it is an optical method of transmission, for example, visible radiation or infrared radiation. In another embodiment, it is an ultrasound signal. [00053] In some embodiments, the system includes an apparatus of some type to hold 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. Without intending to be limiting, the mechanism of data transmission can be cellular data transmission, Wi-Fi, Bluetooth, ZigBee, optical data transmission or other methods. Without intending to be limiting, several embodiments and arrangements of these elements are listed in the examples below.

[00054] In some embodiments, as illustrated in FIGS. 8 A and 8B, the

electrodes 18 may be incorporated into the body of a cellphone and a cellphone application may be used to control the measurement of the data from the body and to calculate parameters 35 based on- the measured data. That is, device 10 maybe a cellphone. The cellphone may be powered by the power supply of the cellphone (such as a battery), or a separate power supply. An application on the cellphone may be used together with the computational capability of the cellphone to control the supply and measurement of current. Voltage measuring capability may be built into the cellphone and the application may be used to analyze voltage and perform calculations. This application can either be the same application used to control the supply of current or a different application. The display capability of the cellphone may be used to display the measured data and the computed parameters 35. If desired, the data transmission capability of the cellphone is used to transmit data and analysis to a remote station for data storage and analysis. Without intending to be limiting, the mechanism of data transmission can be cellular data transmission, Wi-Fi,

Bluetooth, ZigBee, optical data transmission or other methods.

[00055] Other modifications of the above described embodiment are also contemplated. For instance, in some embodiments, the electrodes 18 may be incorporated into a cellphone case which is used to hold and/or protect a cellphone. The power supply may be a separate power supply in the cellphone case which may be charged separately, or may be the power supply of the cellphone. Computational capability may be built into the cellphone case (or may be incorporated in a cellphone application) to control the current. Voltage and current measuring capability may be built into the cellphone case and/or the cellphone. In some embodiments, data may be transmitted between the cellphone case and the cellphone by a wireless method (like Wi-Fi, Bluetooth, ZigBee or optical data transmission, etc.). Alternatively or additionally, in some embodiments, electrical contacts on the cellphone and the cellphone case mate and make an electrical connection when the cellphone is inserted into the case. In some embodiments, the user may activate an electrical connection between the cellphone case and the cellphone (for instance, by inserting a wire connecting them, by activating a switch, etc.) when desired. This electrical connection between the case and the cellphone may then be used to transfer data between them. An application on the cellphone may be used to analyze current and voltage and perform the calculations to compute the parameters 35. The display capability of the cellphone may be used to display the data or a separate display (an external display, etc.) may be used. If desired, the data transmission capability of the cellphone may be used to transmit the data and parameters 35 to a remote station for data storage and analysis. [00056] In some embodiments, the electrodes and electrode apparatus may be incorporated into a cellphone case which is used to hold and/or protect the cellphone. The power supply may be a separate power supply in the cellphone case which may be separately charged. Computational capability in a cellphone app may be used to control the current and the cellphone may be communicating with the cellphone case by some wireless method like Wi-Fi, Bluetooth, ZigBee, optical data transmission or other method. Current and voltage measuring capability may be built into the cellphone case and, without intending to be limiting, data is transmitted from the cellphone case to the cellphone by a wireless method like Wi-Fi, Bluetooth, ZigBee, optical data transmission or other method. An app is used in the cellphone to analyze current and voltage and perform calculations. The display capability of the cellphone may be used to display the data. If desired, the data transmission capability of the cellphone may be used to transmit data and analysis to a remote station for data storage and analysis. Without intending to be limiting, the mechanism of data transmission can be cellular data transmission, Wi-Fi, Bluetooth, ZigBee, optical data transmission or other methods. In some embodiments, the electrodes and electrode apparatus may be incorporated into a cellphone case which may be used to hold and/or protect the cellphone. The power supply may be provided by the cellphone. There may be a connection between the cellphone and the cellphone case which automatically fits in place when the cellphone is inserted into the case. Power may be provided to the cellphone case and to the electrodes in the cellphone case using this connection. Computational capability may be provided by a cellphone app. Current and voltage measuring capability may be built into the cellphone case and, without intending to be limiting, data may be transmitted from the cellphone case to the cellphone by a wireless method like Wi-Fi, Bluetooth, ZigBee, optical data transmission or other method or is transmitted to the cellphone through the connection between the cellphone and the cellphone case. An app may be used in the cellphone to analyze current and voltage and perform calculations. The display capability of the cellphone may be used to display the data. If desired, the data transmission capability of the cellphone may be used to transmit data and analysis to a remote station for data storage and analysis. Without intending to be limiting, the mechanism of data transmission can be cellular data transmission, Wi-Fi, Bluetooth, ZigBee, optical data transmission or other methods. In some embodiments, the electrodes and electrode apparatus may be incorporated into a cellphone case which may be used to hold and/or protect the cellphone. The power supply may be provided by the cellphone. There may be a wired connection between the cellphone and the cellphone case which may be inserted between the cellphone and the cellphone case by a user. Power may be provided to the cellphone case and to the electrodes in the cellphone case using this connection. Computational capability may be provided by a cellphone app. Current and voltage measuring capability may be built into the cellphone case and, without intending to be limiting, data may be transmitted from the cellphone case to the cellphone by a wireless method like Wi-Fi, Bluetooth, ZigBee, optical data transmission or other method or is transmitted to the cellphone through the wired connection between the cellphone and the cellphone case. An app may be used in the cellphone to analyze current and voltage and perform calculations. The display capability of the cellphone may be used to display the data. If desired, the data transmission capability of the cellphone may be used to transmit data and analysis to a remote station for data storage and analysis. Without intending to be limiting, the mechanism of data transmission can be cellular data transmission, Wi-Fi, Bluetooth, ZigBee, optical data transmission or other methods. [00057] In another embodiment, the electrodes 18 may be held in an electrode apparatus (e.g., a strap, band, etc.) separate from the cellphone and is not a cellphone case. The electrode apparatus may then be kept in contact with skin. In some embodiments, the electrode apparatus maybe attached to (e.g., strapped to, etc.) to the user. It is also contemplated that, in some embodiments, the electrodes 18 maybe incorporated into a piece of clothing or accessory (shorts, socks, shoes, arm band, etc.) worn by the user. Power supply for the electrodes 18 may be provided on the electrode apparatus, or may be provided from the power supply of the cellphone. In some embodiments, the electrodes 18 may measure data from a user and direct the data to the cellphone, cell phone case, or another device for computations. Data may be transferred wirelessly or through a wired connection between the electrode apparatus and the cellphone (or other device). In some embodiments, a connection may be established between the cellphone and the electrode apparatus by a user. For example, a wire or a connecting member may be inserted between the cellphone and the electrode apparatus by a user. The wired connection may be removable at both ends or may be permanently attached to the electrode apparatus. Power may be provided to the electrode apparatus and to the electrodes 18 using this connection or alternately by the separate power supply in the electrode apparatus. Similar to the embodiments discussed above, the cellphone may perform the necessary

computations to determine the parameters 35 and display the parameters 35 on the cellphone display and/or transfer them to a remote location using the wireless capability of the cellphone. In some embodiments, the electrodes may be held in an electrode apparatus which is separate from the cellphone and is not a cellphone case. There may be a separate power supply in the electrode apparatus. There may be a wireless data connection between the cellphone and the electrode apparatus which can be Wi-Fi, Bluetooth, ZigBee, optical data transmission or other wireless method.

Computational capability may be provided by a cellphone app. Current and voltage measuring capability may be built into the cellphone case and, without intending to be limiting, data may be transmitted from the remote electrode apparatus to the cellphone by a wireless method like Wi-Fi, Bluetooth ZigBee, optical data transmission or other wireless method. An app may be used in the cellphone to analyze current and voltage and perform calculations. The display capability of the cellphone may be used to display the data. If desired, the data transmission capability of the cellphone may be used to transmit data and analysis to a remote station for data storage and analysis. Without intending to be limiting, the mechanism of data transmission can be cellular data transmission, Wi-Fi, Bluetooth, ZigBee, optical data transmission or other wireless methods.

[00058] In some embodiments, the electrodes 18 may be provided on a electrode apparatus that directly transfers the measured data (wirelessly or through a wired connection) to a remote station (such as, associated device 37 and/or computer system 40) where it is stored and/or analyzed.

[00059] The determination of the effect of vigorous exercise and recovery on EIM of the bicep of a male human subject (of age 35, height 5' 9", and weight 182 lbs) rising device 10 is described below. The electrodes 18 (FIG. 4) of device 10 was applied to the skin of the subject as shown in FIG. 5. Nine baseline pre-exercise EIM measurements were taken over the course of 80 minutes (one every ten minutes) using configuration 1, and Muscle Quality (MQ) computed using the equation, MQ = 3 x Phase at 50 kHz + 25. For example, if for a particular measurement, the phase is 30, the MQ would be (3 x 30) + 25 = 90 + 25 = 115. The average MQ for the baseline measurements was 106.4 with a standard deviation of 0.53. [00060] Four minutes after the final baseline measurement, the subject exercised the right biceps muscle by performing biceps curls 10 times using a 20 pound dumbbell (this took approximately one minute). In a bicep curl, the arm is extended straight and approximately horizontal holding the weight. The muscle is then contracted so that the elbow is bent approximately 90 degrees, with the upper arm (nearest the shoulder) remaining approximately horizontal and the lower arm including the hand holding the weight is approximately vertical. A measurement was performed immediately following the final repetition of exercise and the value of MQ was computed to be 116. The subject rested for one minute and then performed an additional 10 repetitions of biceps curls. Another measurement was made

immediately after resulting in an MQ value of 127. The subject rested for an additional minute and a third set of 10 repetitions of bicep curls were performed followed by another measurement yielding an MQ value of 117. Two minutes later, another measurement was made showing an MQ value of 107. Measurements were then conducted every 2 minutes for the next 20 minutes (a total of 10 measurements at 2 minute intervals), then every 5 minutes for the next 50 minutes (a total of 10 measurements at 5 minute intervals), and then once every 10 minutes. In some cases, multiple measurements were made at the same time. A total of 85 measurements were conducted and MQ computed using device 10.

[00061] FIG. 7 is a plot showing the computed MQ values. These values are also listed in Table I below. As shown in FIG. 7, 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.

Table I: Computed MQ values.

[00063] Using the method described above, or by following a similar method in which the fatigue and/or recovery of an exercising muscle is quantitatively measured, 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 program. Over time, the subject 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.

[00064] In a further example, measurements and calculation of fat Percentage and MQ were obtained. [00065] Measurements of EIM were made on a number of individuals and body fat percentages and MQ were calculated for each person. The equations used to calculate fat percentages and MQ were the following:

[00066] Fat Percentage = R50C1 - 7

[00067] MQ = M(kl*P100Cl^A2 + k2*P50C3^A2 + (k3/R25Cl)^A2 +

(k4/R50Cl)^A2 + (k5/R100Cl)^A2 + (k6/R200Cl)^A2)^A0.5+N

[00068] Where 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, R100C1 means resistance at 100 kHz using configuration 1, R200C1 means resistance at 200 kHz using configuration 1

[00069] In the equation for MQ, the following constants and parameters are used:

[00070] M = 1.1 , kl = 3.6, k2 = 3.4, k3 = 480, k4 = 720, k5 = 240, k6 = 240 And the following values are used for N depending upon specific muscle or body part

[00071] Biceps N: 30, Triceps N: 35, Shoulders N: 30, Forearms N: 30, Chest N: 30, Abs N: 55, Thighs N: 45, Hamstrings N: 30, Calves N: 30, Gluteus Maximus N: 30, Lower Back N: 30, Upper Back N: 30.

[00072] In this disclosure, we define "electrode separation" to mean the distance between two electrodes, for example, electrode 20a and electrode 20e in FIG. 3. We define "set of electrode separations" to mean the separation of the electrodes in a configuration. For example, for configuration 1 , 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). By a "plurality of sets of electrode separations," we mean 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. In the equation for MQ listed above, the calculations use information taken using a plurality of sets of electrode separations, namely configuration 1 and configuration 3.

[00073] By "test protocol", we mean 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. By "device position" we mean the location in which the device is positioned on the tissue with the electrodes in contact with the tissue. By "single device position", we mean that the device is positioned on the tissue and not moved. By "measurements made during a single device position", we mean those measurements made during a single device position during which the device and electrodes are not moved or realigned. It can involve measurements from multiple electrodes or multiple configurations if those are present in the device.

[00074] Data from measurements taken using the technology disclosed here, particularly in the examples 1 and 2 discussed above, is given in the chart below. In these charts, values are given for total body MQ and total body fat percentage. The formulae used to calculate these values are:

[00075] Total MQ = average of MQ of biceps, triceps, quadriceps and abdominals.

[00076] Total body fat percentage = average of body fat percentage of biceps, triceps, quadriceps and abdominals. Subject # 1 2 3 4 5 6 7 8 9 10

Gender M M M M M F F F F F

Weight (lbs) 160 162 140 163 188 142 114 131 115 150

Muscle

MQ

Total Body 144 140 139 132 125 110 96 90 88 87

Biceps 128 131 126 125 126 113 103 95 93 92

Triceps 155 129 116 118 117 104 83 75 70 78

Abs 144 151 147 141 132 116 105 105 107 97

Quads 148 149 148 143 124 101 89 88 82 81

Shoulder 136 122 130 120 124 95 86 89 87 72

Forearm 129 127 112 113 126 114 106 102 86 98

Chest 135 144 137 139 136

UpperBack 108 109 120 113 118 95 88 82 91 79

LowerBack 124 117 105 123 113 92 80 70 74 76

Hamstrings 134 119 122 121 115 77 79 82 67 72

Calves 115 113 113 106 96 63 73 78 67 88

Glutes 67

Subject s 1 2 3 4 5 6 7 8 9 10 Fat Percent

Total Body 8.8 7 11.8 7.6 9.8 16.9 26.7 27 23.3 29.2

Biceps 10.7 10 10.9 9.5 9.9 13.5 19.7 20.2 18.4 20.8

Triceps 9.7 7.1 9.7 7.7 8.8 25 36.5 37.3 31.7 34.5

Abs 7.7 4.8 17.9 6.8 10.7 11.3 18.8 18.1 14.2 35.2

Quads 7.1 6.1 6.8 6.4 9.9 17.5 31.5 31.5 28.9 35.2

Shoulder 7 8.4 7.7 7.7 8.3 13.7 23.2 23.9 16.1 31

Forearm 12.1 11.8 11.1 9.3 9.2 14.8 26.2 14 15.8 17.6

Chest 8.4 5.6 6.6 7.1 6.3

UpperBack 8.5 8.2 7.1 7.2 ^' 6.1 11.4 18.3 16.2 13.6 21.9

LowerBack 6.4 7.9 6.2 7.4 11.4 16.9 25.6 16.1 19.2

Hamstrings 9.2 6.6 7.8 7.4 8.5 17.4 23.9 19.5 24 27

Calves 12.2 10.5 10.3 9.8 12.8 18.8 33 22 27.1 15.1

Glutes 39.8

[00077] In another example, gender specific measurements of MQ were obtained.

[00078] EIM measurements were made using the methods taught in this disclosure and calculated using the equation:

[00079] MQ = M(kl*P100Cl^A2 + k2*P50C2^A2 + (k3/R25Cl)^A2 +

(k4/R50Cl)^A2 + (k5/R100Cl)^A2 + (k6/R200Cl)^A2)^A0.5+N

[00080] M = l.l [00081] Gender specific values were used for N in the equation above.

[00082] Results for some subjects are given in the chart below:

Subject # 11 12

Gender M F

Weight 165.2 113

Muscle

MQ

Biceps 125 118

Calf 124 137

Chest 142 161

Hip 127 107

Lower Back 130 126

Scapula 130 120

Thigh 134 124

Triceps 139 122

Waist 105 129

Subject # 11 12

Fat Percent

Biceps 12.7 18.8

Calf 11.8 12.5

Chest 7.8 38.3

Hip 14.4 21.4

Lower Back 9.1 14.5

Scapula 9.1 14.5

Thigh 11.1 20.1

Triceps 9.9 22.6

Waist 19.2 12.9

[00083] Multiple Part Smartphone Device

[00084] Throughout this disclosure, we will use the terms "cellphone" and "smartphone" interchangeably. They both mean a phone with sophisticated computation, display and wireless capability. Examples of Smartphones would include iPhones, Android phones and other such phones.

[00085] A smartphone based device, illustrated in FIGS. 8A and 8B, is used to make measurements as outlined elsewhere in this disclosure. There are at least three parts to the smartphone based device. They are: 1) the smartphone (810); 2) the electrode assembly which contains the electrodes that are in contact with the tissue

(820); 3) a case or holder which holds the electrode assembly and snaps or fastens securely onto the smartphone (830). There is a hole in the case or holder (840) which is open and allows the electrodes on the electrode assembly (820) to come into direct contact with the tissue. The electrode assembly (820) is located between the smartphone (810) and the case (830) and is held securely in place by the case. There are locating pins or another such mechanism on the electrode assembly and the case to ensure that the electrodes are oriented along the axis of the smartphone or in some other desired orientation.

[00086] This arrangement allows a single design of electrode assembly to be used with a number of designs of smartphones. The electrode assembly can communicate with the smartphone by wire, wireless or direct plug in communication. The electrode assembly can be powered by the smartphone or internally powered.

[00087] In this arrangement, there would be a single design or small number of electrode assemblies designs which would be usable with essentially any design of smartphone. There would be a unique case or holder for each smartphone design.

[00088] We contemplate the use of this technology with iPhones, Android devices, and other such phones. It is contemplated that a case/holder can be designed for new designs of smartphone to allow them to practice the teachings of this disclosure.

[00089] While principles of the present disclosure are described herein with reference to illustrative embodiments for particular applications, it should be understood that the disclosure is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, embodiments, and substitution of equivalents all fall within the scope of the embodiments described herein. Accordingly, the invention is not to be considered as limited by the foregoing description.

40

Claims

We claim:

1) A method for measuring the properties of tissue comprising a) having a device which comprises:

i) a power supply contained in the device;

ii) a case;

iii) at least four electrodes in the case of which at least two are current supplying electrodes and at least two are voltage measuring electrodes and the electrodes are oriented along an axis of the device;

iv) electronics to provide and control a current impressed through the tissue;

v) electronics to measure the voltage which results from impressed current;

vi) calculation capability to analyze the voltage and calculate one or more properties of the tissue;

vii) computer memory capability to store the measured data and the calculated properties;

viii) display capability to display the one or more calculated properties of the tissue;

b) placing the device so that at least two current supplying electrodes and at least two voltage measuring electrodes are in contact with the tissue over a muscle or muscle group of interest and the electrodes are roughly oriented along the muscle or muscle group of interest;

c) using the device to impress a current through the tissue;

d) using the device to analyze the voltage; and e) using the device to calculate one or more properties of the tissue based on the analyzed voltage;

f) displaying on the device at least one calculated property of the tissue.

2) The method of claim 1 in which the longest linear dimension of the device is not greater than 5 inches.

3) The method of claim 1 in which the time from beginning of the current impression to the display of the at least one calculated property of the tissue is not greater than about 10 seconds.

4) The method of claim 1 in which the at least one calculated property comprises fat percentage.

5) The method of claim 4 in which the equation used by the device to calculate fat percentage is either Simple Muscle Fat Percentage =0.35/ohms x ({Muscle Resistance at 50 kHz} + {Muscle Resistance at 100 kHz} + {Biceps Muscle at 200 kHz}) or Muscle Fat Percentage = 100 x tanh( 0.0036 x ({Muscle Resistance at 50 kHz} + {Muscle Resistance at 100 kHz} + {Muscle Resistance at 200 kHz}) or Muscle Fat Percentage = R50C1 - 7.

6) The method of claim 1 in which the at least one calculated property comprises muscle quality.

7) The method of claim 6 in which the equation used by the device to calculate and display muscle quality is either Muscle Quality (1) of a specific muscle = 100 x tanh (Muscle Percentage of that specific muscle / Fat Percentage of that specific muscle / 4.5) or Muscle Quality(2) of a specific muscle = Muscle Quality (1) of that specific muscle + 2.1 x Gender + 0.1 x weight/height2 where Gender = 1 for males and Gender = 0 for females.

8) A method for measuring the fatigue of a muscle comprising:

a) having a device including:

i) a power supply contained in the device;

ii) a case;

iv) electronics to provide and control a current impressed through the tissue;

v) electronics to measure the voltage which results from impressed current;

viii) display capability to display the one or more calculated properties of the tissue; b) placing the device so that at least two current supplying electrodes and at least two voltage measuring electrodes are in contact with the tissue over a muscle or muscle group of interest and the electrodes are roughly oriented along the muscle or muscle group of interest;

c) using the device to. impress a current through the tissue;

d) using the device to analyze the voltage;

e) using the device to calculate one or more properties of the tissue based on the analyzed voltage;

f) displaying on the device at least one calculated property of the tissue; g) using device to make plurality of measurements at different times on a single muscle or muscle group during a time that the muscle is exercising; and

h) noting the change in an electrical property of the muscle which occurs while the muscle is exercising.

9) The method of claim 8 further comprising calculating the muscle qualities based on the measurements made and noting the change in muscle quality of the muscle which occurs while the muscle is exercising.

10) The method of claim 8 further comprising making a plurality of measurements prior to exercise to establish a baseline value.

11) The method of claim 9 further comprising calculating a plurality of muscle quality values based on the measurements made prior to exercise to establish a baseline value of muscle quality.

12) The method of claim 10 further comprising making a plurality of measurements after exercise of the muscle has ceased and noting when the values of the electrical property have returned to about the baseline value.

13) The method of claim 12 further comprising making a calculating a plurality of muscle quality values based on the measurements made after exercise has ceased and noting when the value of the muscle quality values have returned to about the baseline value.

14) A method of estimating the total body fat of a person by making measurements of body fat using the method of claim 8 at a plurality of predetermined places on the body and using an equation to calculate the total body fat percentage.

15) The method of claim 14 in which the predetermined places are the biceps, the abdomen, the quadriceps and the scapula and the formula to calculate total body fat percentage is Total Body Fat Percentage = 0.19 x Biceps Fat Percentage + 0.30 x Abdominal Fat Percentage + 0. 28 x Quadriceps Fat Percentage + 0.23 x Scapula Fat Percentage + 1.5 x Gender - 0.02 x weight/height2 + 0.05 x age.

16) The method of claim 8 in which the device further comprises the capability to communicate wirelessly with a network or with a computer and the device transmits measurement information to a computer or network.

17) The method of claim 16 in which the information is displayed on a website, either with or without further calculation and processing.

18) The method of claim 9 in which the computer memory capability is sufficient to store the data from a plurality of measurements and the device further comprises fastening capability to fasten the device to the user during exercise, the device is worn by the' user while the plurality of measurements is taken and stored.

19) The method of claim 18 in which the device further comprises the capability to communicate wirelessly with a network or with a computer and the device transmits the plurality of measurement information to a computer or network.

20) The method of claim 19 in which the computer or network further calculates and presents information on muscle fatigue based on the transmitted plurality of measurement information.

21. A method according to claim 6 in which a test protocol used in the method comprises a plurality of sets of electrode separations.

22. A method according to claim 21 in which the test protocol further comprises measurements made during a single device position.

23. A method according to claim 22 in which the equation or equations used to calculate muscle quality comprise the use of data taken from a plurality of sets of electrode separations.

24. A method according to claim 23 in which the equation used to calculate muscle quality comprises MQ = M(kl*P100Cl^A2 + k2*P50C3^A2 +

(k3/R25Cl)^A2 + (k4/R50Cl)^A2 + (k5/R100Cl)^A2 + (k6/R200Cl)^A2)^A0.5+N.

25. The method according to claim 5 in which the equation used to calculate muscle fat percentage comprises Muscle Fat Percentage = R50C1 - 7

26. A method for determining total body fat percentage in which the body fat percentage of the biceps, triceps, quadriceps and abdominal muscle groups is measured according to the method of claim 25 and the equation used to calculate total body fat percentage is Total body fat percentage = (Biceps fat percentage + triceps fat percentage + quadriceps fat percentage + abdominal muscles fat percentage )/ 4

27. A method for determining total body muscle quality in which the muscle quality of the biceps, triceps, quadriceps and abdominal muscle groups is measured according to the method of claim 24 and the equation used to calculate total body muscle quality is Total body muscle quality = (Biceps muscle quality+ triceps mus-'cle quality + quadriceps fat muscle quality + abdominal muscles muscle quality )/ 4.

28. A device for measuring bioimpedance-related properties of tissue, comprising:

a portable case;

a power supply in the case; a plurality of electrodes spaced apart and arranged along an axis of the case, the plurality of electrodes including at least one pair of current electrodes configured to direct a current through the tissue and at least one different pair of voltage electrodes configured to measure a voltage;

electronic circuitry in the case, the electronic circuitry being configured to control the current directed through the tissue and calculate at least one

bioimpedance-related property of the tissue based at least on the measured voltage and the impressed current; and

a screen on the case, the screen being configured to display one or more of the calculated at least one property.

29. The device of claim 28, wherein the device is configured to wirelessly transmit the calculated at least one property to a remotely located device.

30. The device of claim 28, wherein the case includes at least one indicator configured to indicate a status of the measurement to a user.

31. The device of claim 30, wherein the at least one indicator is configured to indicate at least one of (a) when the plurality of electrodes make contact with the tissue, and (b) when the measurement is complete.

32. The device of claim 28, wherein the case includes one or more buttons configured to initiate the measurement.

33. The device of claim 28, wherein the at least one pair of current electrodes are positioned radially outwards of the at least one pair of voltage electrodes.

34. The device of claim 28, wherein the plurality of electrodes include (a) a first set of electrodes spaced apart and arranged along a first axis, the first set including at least one pair of current electrodes and one pair of voltage electrodes, and (b) a second set of electrodes spaced apart and arranged along a second axis perpendicular to the first axis, wherein the second set includes a pair of current electrodes and a pair of voltage electrodes positioned radially inwards of the pair of current electrodes.

35. The device of claim 34, wherein the first set of electrodes are arranged symmetrically about the second axis and the second set of electrodes are arranged symmetrically about the first axis.

36. The device of claim 34, wherein the first set of electrodes include two pairs of current electrodes and two pairs of voltage electrodes.

37. The device of claim 36, wherein each electrode of the two pairs of current electrodes are larger than each electrode of the two pairs of voltage electrodes.

38. A device for measuring bioimpedance-related properties of tissue, comprising: a first set of electrodes spaced apart and arranged along a first axis of the device, the first set including a first pair of current electrodes and a second pair of voltage electrodes;

a second set of electrodes spaced apart and arranged along a second axis of the device perpendicular to the first axis, wherein the second set includes a third pair of current electrodes and a fourth pair of voltage electrodes, and wherein (a) the first set of electrodes are arranged symmetrically about the second axis and the second set of electrodes are arranged symmetrically about the first axis, and (b) each pair of current electrodes are configured to direct a current through the tissue and each pair of voltage electrodes are configured to measure a voltage; and

electronic circuitry configured to measure the voltage across at least one pair of voltage electrodes and calculate at least one bioimpedance related property of the tissue based at least on the measured voltage and the impressed current.

39. The device of claim 38,. wherein the electrodes of each pairs of current electrodes are larger than the electrodes of each pair of voltage electrodes.

40. The device of claim 38, wherein the first set of electrodes further include a fifth pair of current electrodes and a sixth pair of voltage electrodes.

41. The device of claim 40, wherein the electronic circuitry is configured to (c) direct a current through the first pair of current electrodes and measure a first voltage across the second pair of voltage electrodes, (d) direct a current through the third pair of current electrodes and measure a second voltage across the fourth pair of voltage electrodes, (e) direct a current through the fifth pair of current electrodes and measure a third voltage across the sixth pair of voltage electrodes, and (f) calculate the at least one bioimpedance-related property using at least one of the measured first, second, and third voltage.

42. A method of measuring a bioimpedance-related property of tissue, comprising:

positioning a plurality of electrodes of a portable device in contact with the tissue, wherein the plurality of electrodes include a first set of electrodes spaced apart and arranged along a first axis of the device, and wherein the first set of electrodes includes a first pair of current electrodes configured to direct a current through the tissue and a second pair of voltage electrodes configured to measure a voltage;

directing a current through the first pair of current electrodes;

measuring a voltage across the second pair of voltage electrodes;

calculating, using electronic circuitry of the device, a bioimpedance related property of the tissue based at least on the measured voltage and the directed current; and

displaying, on a screen of the device, the calculated bioimpedance related property.

43. The method of claim 42, wherein the plurality of electrodes further include a second set of electrodes spaced apart and arranged along a second axis of the device perpendicular to the first axis, wherein the second set includes a third pair of current electrodes and a fourth pair of voltage electrodes, wherein the first set of electrodes are arranged symmetrically about the second axis and the second set of electrodes are arranged symmetrically about the first axis, and wherein directing the current further includes directing the current through the third pair of current electrodes; and

measuring the voltage further includes measuring the voltage across the fourth pair of voltage electrodes.

44. The method of claim 43, wherein calculating the bioimpedance-related property includes calculating the property based on the voltage across the second pair of voltage electrodes and the voltage across the fourth pair of voltage electrodes.

45. The method of claim 42, wherein the first set of electrodes further includes a fifth pair of current electrodes and a sixth pair of voltage electrodes spaced apart and arranged along the first axis of the device, and wherein

directing the current further includes directing the current through the fifth pair of current electrodes;

measuring the voltage further includes measuring the voltage across the sixth pair of voltage electrodes; and

calculating the bioimpedance related property includes calculating the property based on the voltage across the second pair of voltage electrodes and the voltage across the sixth pair of voltage electrodes.

46. The method of claim 42, further including activating an indicator of the device when the plurality of electrodes are in contact with the tissue.

47. The method of claim 42, further including wirelessly transmitting the calculated bioimpedance related property to a remote device.