Patent Description:
The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that the prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates.

One existing technique for determining biological indicators relating to a subject, such as cardiac function, body composition, and other health status indicators, such as the presence of oedema, involves the use of bioelectrical impedance. This process typically involves using a measuring device to measure the electrical impedance of a subject's body using a series of electrodes placed on the skin surface, although other techniques could be used. Changes in electrical impedance are used to determine parameters, such as changes in fluid levels, associated with the cardiac cycle, oedema, or the like.

Impedance measuring apparatus is sometimes sensitive to external factors, including stray capacitances between the subject and the local environment and the measurement apparatus, variations in electrode/tissue interface impedances, also known as electrode impedances, as well as stray capacitances and inductive coupling between the leads used to connect the measuring device to the electrodes, meaning measurements performed by an impedance measuring device are not always accurate.

Measurements are typically evaluated manually by having user's view a visual representation of measured impedance values to see if these "look correct". Such a subjective assessment is difficult for inexperienced users to perform, meaning accurate measurements may be discarded, whilst inaccurate measurements are used, which can in turn can lead to incorrect calculation of biological indicators.

<CIT> discloses a method and apparatus for testing the plausibility of electric impedance measurement values. The measurement values are determined during the measurement of the bioimpedance of a person. <CIT> discloses an apparatus for analysis of body composition and hydration status by detecting resistance of the human subject at zero and infinite frequency including a method for measuring indirectly extracellular water mass, intracellular water mass, lean body mass, and body fat mass. <CIT> discloses a method for determining biological indicators, the method including, in a processing system causing at least one radiation attenuation measurement to be performed and determining at least one first biological indicator using determined radiation attenuation. <CIT> discloses a method of monitoring mucosal injury due to hypoperfusion and ischemia in the critically ill.

In one broad form an aspect of the present invention seeks to provide a system for performing a bioimpedance measurement on a biological subject as provided in claim <NUM>.

In one broad form an aspect of the present invention seeks to provide a method for use in evaluating a bioimpedance measurement performed on a biological subject as provided in claim <NUM>.

In one embodiment the impedance curve is a circular segment.

In embodiments the evaluation of the impedance measurements is used to categorise the impedance measurement; and, derive an indicator indicative a measurement categorisation.

In one embodiment the impedance measurement is categorised as being at least one of: bad; questionable; and, acceptable.

In one embodiment the one or more processing devices: use the deviation to calculate an estimated error in impedance parameter values, the impedance parameter values being derived from the impedance curve; and, use the estimated error to evaluate the impedance measurements.

In one embodiment the one or more processing devices calculate a respective estimated error for each of a number of impedance parameter values.

In one embodiment the one or more processing devices: compare the estimated error to one or more thresholds; and, evaluate the impedance measurement based on results of the comparison.

In one embodiment one or more processing devices: calculate curve coefficients using the curve fitting algorithm; and, determine the deviation using the curve coefficients and the impedance values.

In one embodiment the curve fitting algorithm uses a method of least squares.

In one embodiment the one or more processing devices calculate an estimated error by propagating the deviation to the impedance parameter values.

In one embodiment the deviation is based on at least one of: a variance; and, a co-variance.

In one embodiment the one or more processing devices: determine the deviation by calculating a co-variance matrix indicative of variances and co-variances associated with the impedance curve and the impedance values; and, use the co-variance matrix to estimate the error.

In one embodiment the co-variance matrix is generated based on a mean square error of the impedance curve and the impedance values.

In one embodiment the one or more processing devices calculate the co-variance matrix using the equation: <MAT> where: A is a matrix of measured reactance values X and resistance values R of the form <MAT> is the mean square error of the curve fit.

In one embodiment the one or more processing devices calculate an estimated error using first order partial derivatives of a vector function.

In one embodiment the one or more processing devices calculate an estimated error using a Jacobian transform.

In one embodiment the one or more processing devices calculate an estimated error by applying a Jacobian transform to a co-variance matrix using the equation: <MAT> where: J is a Jacobian transform; JT is an inverse Jacobian transform; <MAT> is the error.

In one embodiment the one or more processing devices: calculate an error value associated with a number of impedance parameter values; compare each of error value to at least one respective threshold; and, perform the evaluation based on results of the comparison.

In one embodiment the number of impedance parameter values include one or more of: R<NUM> which is the theoretical impedance at a frequency of OkHz; Rinf which is the theoretical impedance at an infinite frequency; and, Ri which is the intracellular impedance.

In one embodiment the one or more processing devices calculate error values using the equations: for R<NUM>: <MAT> where: JR0 is a Jacobian transform for R<NUM>; JTR0 is an inverse Jacobian transform for R<NUM>; and, <MAT> is a co-variance matrix; for Rinf <MAT> where: JRinf is a Jacobian transform for Rinf; JTRinf is an inverse Jacobian transform for Rinf; and, <MAT> is a co-variance matrix; and, for Ri <MAT> where: JRi is a Jacobian transform for Ri; JTRi is an inverse Jacobian transform for Ri; and, <MAT> is a co-variance matrix.

In one embodiment the one or more processing devices evaluate the impedance measurement based on a number of negative reactance values.

In one embodiment the one or more processing devices evaluate the impedance measurement as being: in a first category if at least one of: a number of negative reactance measurements exceeds a first category reactance threshold; or at least one parameter value has an error greater than a respective first category threshold; in a second category if at least one of: a number of negative reactance measurements exceeds a second category reactance threshold; each parameter value has an error greater than a respective second category threshold; in a third category if it is not in the first or second category.

In one embodiment the one or more processing devices evaluate the impedance measurement as being: in a first category if: an R<NUM> error is greater than a first category R<NUM> threshold; in a second category if at least one of: an Ri error is greater than a first category Ri threshold; and, an Rinf error is greater than a first category Rinf threshold.

In one embodiment the one or more processing devices evaluate the measurement at least in part using one or more thresholds, and wherein the thresholds are at least one of: determined based on evaluation of previous impedance measurements performed for the subject determined based on evaluation of previous measurements impedance performed for one or more reference subjects; and, determined by applying machine learning to evaluation of previous impedance measurements performed for one or more reference subjects.

In one embodiment the one or more processing devices select at least one threshold in accordance with at least one of: subject characteristics; and, an impedance analysis process being performed.

In one embodiment the one or more processing devices: evaluate the impedance measurement using at least one threshold; determine a user assessment of the impedance measurement in accordance with user input commands; and, selectively modify the at least one threshold based on the user assessment.

In one embodiment the one or more processing devices evaluate the measurement using at least one computational model embodying a relationship between different deviations and measurement validity.

In one embodiment the at least one computational model is obtained by applying machine learning to deviations and assessments of measurement validity obtained from one or more reference subjects.

In one embodiment the one or more processing devices: apply a phase correction to impedance values measured at a frequency higher than a set frequency; and, calculate the impedance curve using the phase corrected impedance values.

In one embodiment each impedance value includes a reactance value and a resistance value.

In one embodiment the one or more processing devices: determine a count of impedance values having negative reactance values; and, use the count to perform an evaluation of the impedance measurements.

In one embodiment the one or more processing devices: apply a phase correction to impedance values measured at a frequency higher than a set frequency; and, determine the count using the phase corrected impedance values.

In one embodiment the one or more processing devices evaluate the impedance measurement as being: in a first category if the count is greater than <NUM>% of a total number of impedance values; and, in a second category if the count is greater than <NUM>%.

In one embodiment the one or more processing devices: calculate an impedance parameter value using the impedance values; compare the impedance parameter value to a defined frequency impedance value, the defined frequency impedance value being determined from an impedance value obtained from impedance measurements performed at a defined measurement frequency; and, use a result of the comparison to perform an evaluation of the impedance measurements.

In one embodiment: the parameter value is R<NUM> which is the theoretical impedance at a frequency of OkHz; and, the defined frequency impedance value is determined from an impedance measurement performed at at least one of: greater than <NUM>; less than <NUM>; less than <NUM>; less than <NUM>; between <NUM> and <NUM>; and, about <NUM>.

In one embodiment: the parameter value is Rinf which is the theoretical impedance at an infinite frequency; and, the defined frequency impedance value is determined from an impedance measurement performed at at least one of: greater than <NUM>; greater than <NUM>; less than <NUM>; less than <NUM>; less than <NUM>; between <NUM> and <NUM>; and, about <NUM>.

In one embodiment the parameter value is a theoretical impedance at the defined frequency.

In one embodiment the one or more processing devices evaluate the impedance measurement as being: in a first category if a magnitude of a difference between the impedance parameter value and the defined frequency impedance value is greater than a first difference threshold; and, in a second category if a magnitude of the difference between the impedance parameter value and the defined frequency impedance value is greater than a second difference threshold but less than the first difference threshold.

It will be appreciated that the broad forms of the invention and their respective features can be used in conjunction and/or independently, and reference to separate broad forms is not intended to be limiting. Furthermore, it will be appreciated that features of the method can be performed using the system or apparatus and that features of the system or apparatus can be implemented using the method.

Examples of various embodiments of the present invention will now be described with reference to the accompanying drawings, in which: -.

An example of a method for evaluating a bioimpedance measurement performed on a biological subject will now be described with reference to <FIG>.

For the purpose of this example, it is assumed that the impedance measurement process is being used to determine impedance parameter values, such as extrapolated values of the impedance at theoretical frequencies. These can then be used in order to determine one or more indicators indicative of a body state value, such as a fluid status, a body composition value, a disease state indicator indicative of a presence, absence, or degree of a medical condition such as heart failure, lymphedema, or the like. However, it will be appreciated that this is not essential, and that the techniques described herein could be used to evaluate bioimpedance measurements performed on biological subjects for other reasons.

For the purpose of illustration, it is also assumed that the process is performed at least in part using one or more electronic processing devices forming part of one or more processing systems, connected to one or more measuring systems, such as impedance measuring systems or the like. In one example, this is performed at least using a cloud based architecture that interfaces with measuring systems or other client devices, as will be described in more detail below. Whilst the system can use multiple processing devices, with processing performed by one or more of the devices, for the purpose of ease of illustration, the following examples will refer to a single device, but it will be appreciated that reference to a singular processing device should be understood to encompass multiple processing devices and vice versa, with processing being distributed between the devices as appropriate.

In one example, the measuring device includes a signal generator electrically connected to drive electrodes to apply drive signal to a user, a sensor electrically connected to sense electrodes to measure a response signal in the user and one or more processing devices that at least in part controls the signal general, receives an indication of a measured response signal from the sensor and calculates at least one measured impedance value.

For ease of explanation, the term "subject" refers to any animal or animal tissue that is being assessed, and more particularly a human, although this is not intended to be limiting and the techniques could be applied more broadly to other vertebrates, mammals or tissues.

In this example, at step <NUM> an impedance measurement is performed by applying electrical stimulation signals at a number of different frequencies and measuring resulting response signals in the body, allowing a number of impedance values to be determined.

In one example, the impedance values are measured over many frequencies ranging from very low frequencies (<NUM>) to higher frequencies (<NUM> or <NUM>), with some devices measuring impedance values at <NUM>, or more, different frequencies within this range, although this is not essential and other configurations of measurement frequency could be used. For example, in some cases only four measurements are recorded, with these being over a range of frequencies, such as frequencies of about <NUM>, <NUM>, <NUM>, and <NUM>, or the like.

The impedance measurements can be of any form and could include whole of body or segmental impedance measurements, and examples will be described in more detail below. The impedance measurements could be performed as part of an analysis process, or alternatively could be performed by a separate measuring device, with analysis, including evaluation, being subsequently performed by the one or more processing devices, for example by retrieving results from a database, receiving the results from a measuring device, or the like.

At step <NUM>, the impedance values are used to calculate an impedance curve, which is typically performed using a curve fitting algorithm, and in one particular example, a circle fitting algorithm, although other suitable techniques could be used.

In this regard, <FIG> is an example of an equivalent circuit that effectively models the electrical behaviour of biological tissue. The equivalent circuit has two branches that represent current flow through extracellular fluid and intracellular fluid, respectively. The extracellular fluid component of biological impedance is represented by an extracellular resistance Re, whilst the intracellular fluid component is represented by an intracellular resistance Ri and a capacitance C representative of the cell membranes.

The relative magnitudes of the extracellular and intracellular components of impedance of an alternating current (AC) are frequency dependent. At zero frequency the capacitor acts as a perfect insulator and all current flows through the extracellular fluid, hence the resistance at zero frequency, R<NUM>, equals the extracellular resistance Re. At infinite frequency the capacitor acts as a perfect conductor and the current passes through the parallel resistive combination. The resistance at infinite frequency R∞ is given by: <MAT>.

Hence the intracellular resistance is given by: <MAT>.

Accordingly, the impedance of the equivalent circuit of <FIG> at an angular frequency ω, where ω=2π*frequency, is given by: <MAT> where: R∞= impedance at infinite applied frequency.

However, the above represents an idealised situation which does not take into account the fact that the cell membrane is an imperfect capacitor. Taking this into account leads to a modified model in which: <MAT> where: α has a value between <NUM> and l and can be thought of as an indicator of the deviation of a real system from the ideal model and represents a depression of the centre of the arc below the axis.

Each measurement provides the impedance a magnitude and impedance phase or, alternatively, resistance and reactance. Plotting the impedance values from multiple frequencies in a reactance-resistance graph often describes a semi-circular plot referred to as a complex impedance plot, and an example plot is shown in <FIG>.

As frequency increases, the reactance increases to a peak at the characteristic frequency and then decreases while the resistance continually decreases. This results in a substantially circular locus with the centre of the circle below the x axis, as shown. In this example, Zi indicates a single impedance value, at an arbitrary frequency fi, having a phase angle of ϕi. The lines represented by Ui and Vi are chords drawn from the endpoints, R∞ and R<NUM> to Zi. If the log of the ratio of all possible chords Ui and Vi are plotted against log frequency, this should be a straight line crossing the x axis at fc and having a slope of (-α).

Whilst the measured impedance can be used directly, more typically the measured impedance is used to derive an impedance parameter and in this regard, the semi-circular complex impedance plot allows the determination of a number of impedances at key theoretical values that are not directly measurable due to practical reasons.

One example, is R<NUM>, which is the impedance measured at the frequency of zero kilohertz. This is also known as direct current and is not suitable for use on humans for a number of reasons. R<NUM> represents the best theoretical value of impedance in the extracellular space. At this frequency the current travels solely through the extracellular fluid compartment. Thus, the opposition (impedance) of this current is due to the extracellular fluid (ECF) alone. As can be seen from the complex impedance plot, the reactance component (caused by cellular membrane interaction with the current) of the impedance vector in this case is zero.

Another parameter is Rinf (also referred to in literature as R∞), which is the impedance measured at the theoretical frequency of infinite kilohertz. Again, no such frequency current is achievable, but the complex impedance plot allows this to be used to extrapolate this value of impedance. This extrapolation is made possible because the frequencies measured to generate the plot allow the accurate determination of the radius of the circle. At infinite frequency, the current will not be affected by interaction with the cell membranes and will pass right through the cell membranes. Therefore, the impedance at Rinf is the impedance due to both the extracellular and intracellular fluid, that is, the total body water. At this theoretical frequency the reactance component of impedance vector is also zero. This allows R∞ to be used with R<NUM> to derive an intracellular resistance Ri, as well as other impedance parameters, such as Xc, Zc or α.

The nature of the curve fitting algorithm will vary depending on the preferred implementation. In one example, a regression procedure is then used to fit the measured data to the theoretical semi-circular locus, although alternatively, a circle fitting technique can be used in which three simultaneous equations representing the geometric relationships between points on a circle are solved to allow calculation of the radius (r) and the co-ordinates of the centre of the circle (i, j) as the three parameters which define the circle. It will also be appreciated that linear or non-linear methods, such as a non-linear least squares approach could be used, which can in turn simply downstream propagation of errors to the impedance parameter values, which is discussed in more detail below.

The above described equivalent circuit models the resistance as a constant value and does not therefore accurately reflect the impedance response of a subject, and in particular does not accurately model the change in orientation of the erythrocytes in the subject's blood stream, or other relaxation effects. To more successfully model the electrical conductivity of the human body, an improved CPE based model may alternatively be used. In this instance, it will be appreciated that the complex impedance plot might not define a circle, and an alternative curve could be used. Whilst the following description will focus on the use of a circular segment, it will be appreciated that this is not intended to be limiting and other curves could be used.

At step <NUM>, the one or more processing devices determine a deviation of the impedance curve from the impedance measurements. In this regard, it will be appreciated that the impedance measurements do not generally fit exactly on the theoretical curve, with variations from the theoretical curve representing measurement inaccuracies. The deviation therefore represents variations between the measured impedance values. The nature of the deviation and the manner in which the deviation is determined will vary depending on the preferred implementation. For example, the deviation could be a standard deviation, a mean square error of fit, or could be assessed as a variance and/or co-variance between the measured impedance values and corresponding points on the curve.

At step <NUM>, the deviation can be used to perform an evaluation of the impedance measurements. In particular, the deviation is assessed to evaluate if the impedance measurement is valid, and in particular whether the measurement is usable or is too inaccurate. In one example, this is achieved by using the deviation to assess the resulting errors in the impedance parameter values, with this being used to assess whether use of the measurement would result in inaccurate parameter values, which could in turn affect resulting indicators. In another example, this is performed using machine learning techniques.

The evaluation can then optionally be used to accept or reject impedance measurements at step <NUM>. This could be performed automatically, but more typically is achieved by displaying results of the evaluation to a user, and allowing the user to make the final decision regarding whether or not a measurement should be rejected. Thus in this instance, the process is performed to assist or guide users in assessing whether or not measurements are accurate and/or usable.

Accordingly, the above described arrangement provides a mechanism to evaluate impedance measurements performed on a biological subject, by comparing deviation of the measurements from a theoretical measurement locus, based on an idealised response of a biological subject. Results of the evaluation can then be used to assist in assessing whether the impedance measurement should be accepted as valid or should be rejected and optionally repeated. Thus, this turns the assessment of measurement validity from being a purely subjective test, to being an at least partially objective assessment, thereby ensuring that less inaccurate measurements are used. This can help ensure that resulting impedance parameter values are more accurate, in turn improving the ability of the system to accurately calculate indicators relating to the biological subject, which can further lead to improved patient outcomes, or the like.

A number of further features will now be described.

As mentioned above, the impedance curve is typically a circular segment. However, it will be appreciated that other curves could be used in some situations. For example, with some scenarios, impedance measurements at higher frequencies can be inaccurate due to capacitive effects. This can be compensated using a phase correction procedure, as will be described in more detail below, which adjusts measured impedance values so that they more correctly align with the circular locus. However, it will be appreciated that as an alternative to performing phase correction, a curve other than a circular locus could be used to account for high frequency effects. Despite this, it will be noted that the use of a circle is particularly advantageous as this represents the idealised biological response and also simplifies the mathematics of evaluating the error, in turn reducing computational requirements for the one or more processing devices.

The evaluation of the impedance measurements is typically used to help determine an impedance measurement validity. In one example, this is achieved by categorising the impedance measurement, for example, providing the measurement with a ranking, such as good, acceptable or bad, which may be denoted by a red, yellow or green, traffic light style indication. However, it will be appreciated that other mechanisms of indicating the likely impedance measurement validity can be used, such as presenting a "confidence of fit" score, such as a %, or the like, which is indicative of a degree of similarity and/or deviation between the impedance curve and the measured impedance values. Such indicators can then be used by an operator, to assist the operator in understanding whether the measurement is acceptable. Additionally and/or alternatively, the assessment could be used to cause the impedance measurement to be repeated automatically. In this instance, no information need be presented to the user, although alternatively a user could be informed the measurement was unacceptable, and asked to check electrode connections or similar. As a further option, the assessment could be used to derive an indicator indicative of the measurement categorisation, or the like, allowing the user to use this in guiding their own assessment of whether the measurement is acceptable.

In one example, the processing devices use the deviation to calculate an estimated error in impedance parameter values derived from the impedance curve and then use the estimated error to evaluate the impedance measurements. In this example, the assessment is performed to take into account that whilst the curve fit might not be particularly accurate, for example if some of the impedance values deviate significantly from the idealised curve, this might nevertheless still result in reasonably accurate parameter values. Accordingly, by estimating the error in the parameter values, this can be used to allow impedance measurements that would be rejected due to deviation alone to be accepted if the deviation does not affect the resulting parameter values. Similarly, this will allow some impedance measurements to be assessed as invalid even if the deviation is minimal, as long as the resulting impedance parameter values would be inaccurate. It will be appreciated that this improves the assessment of measurement validity, taking into account whether inaccuracies would have a material effect on the resulting calculated parameter values.

Whilst a single error could be calculated, more typically the processing device calculates an error associated with each of a number of different impedance parameter values. This allows an assessment to be made of whether relevant parameter values are affected. For example, if the impedance measurements are made for assessing extra-cellular fluid levels only, inaccuracies in Rinf might not be problematic, as long as R<NUM> is accurate.

Having calculated one or more estimated errors, the processing devices can compare the estimated error to one or more thresholds and evaluate the impedance measurement based on results of the comparison. In this regard, a threshold can be set to assess whether or not an error in the parameter value is meaningful or not, and hence whether the measurement should be considered as valid.

The thresholds can be of any appropriate form but are typically based on an evaluation of previous impedance measurements. For example, previous measurements can be examined and assessed to determine measurements that should be considered valid, with errors then being calculated and used to define thresholds distinguishing between valid and invalid measurements. The thresholds can be derived from measurements performed on one or more reference subjects, such as reference subjects, using a statistical analysis and/or using machine learning techniques.

It will be appreciated however that generic thresholds might not be particularly accurate. For example, a measurement for an elderly patient having lymphedema may be quite different to a healthy teenager. Accordingly, in one example, thresholds are selected based on characteristics of the current subject, such as a similar age, height, weight, sex, medical symptoms or conditions, ethnicity, or the like. This can then be used to select thresholds derived from reference subjects having similar characteristics, making the thresholds relevant to the current subject.

Additionally and/or alternatively, the thresholds could be selected taking into account an impedance analysis process being performed. For example, as mentioned above, if the impedance measurement process is being performed to determine extra-cellular fluid levels, the value of R<NUM> might need to be accurate, whilst the value of Rinf could be significantly less accurate, allowing different thresholds to be used as compared to if intra-cellular fluid levels are being measured.

In another example, subject specific thresholds can be used. In this regard, a custom threshold can be established for individual subjects to take into account that different subjects will respond differently to impedance measurements, so that a measurement that is unacceptable for one subject, might be acceptable for another subject. A good example of this is that subjects with dry skin typically have worse measurements than subjects with normally hydrated skin. In this instance, when a subject first undergoes impedance measurements, a default threshold could be used, with the threshold then being modified to take into account feedback from a user. Thus, the processing device can evaluate the impedance measurement using at least one threshold, determine a user assessment of the impedance measurement in accordance with user input commands and then selectively modify the at least one threshold based on the user assessment. For example, if a measurement is assessed to be unacceptable, but the user chooses to accept the measurement, the threshold could be adjusted to take this into account, allowing the system to become more effective over time.

In one example the processing devices calculate curve coefficients using the curve fitting algorithm and then determine the deviation using the curve coefficients and the impedance values. In one particular example, this is achieved using a method of least squares, with the deviation being determined based on a variance and/or co-variance between the impedance values and corresponding values from the curve.

Having determined the deviation, this is then propagated to the impedance parameter values, allowing an estimated error in each impedance parameter value to be determined.

In one example propagation of the error is achieved by determining the deviation by calculating a co-variance matrix indicative of variances and co-variances associated with the impedance curve and the impedance values and then using the co-variance matrix to estimate the error. In this case, the co-variance matrix is generated based on a mean square error of the impedance curve and the impedance values, for example using the equation: <MAT> where: A is a matrix of measured reactance values X and resistance values R of the form A = [<NUM> R X] <MAT> is the mean square error of the curve fit.

The error can be determined in any appropriate manner and in one example, this is achieved using first order partial derivatives of a vector function, and in particular using a Jacobian transform. In this instance, the estimated error can be determined by applying the Jacobian transform to the co-variance matrix using the equation: <MAT> where: J is a Jacobian transform;.

An error is typically calculated for each of the impedance parameter values, allowing each error value to be compared to a respective threshold so that the evaluation can be performed based on results of the comparison. This is typically performed for at least R<NUM>, which is the theoretical impedance at a frequency of <NUM> and Rinf; which is the theoretical impedance at an infinite frequency and may also be performed for Ri, which is the intracellular impedance.

In this example, the respective equations for calculating the error become: <MAT> <MAT> <MAT> <MAT> <MAT> <MAT>.

In some circumstances, measured reactances can have negative values, which is again indicative of an issue with the measurement. Accordingly, in one example, the processing devices can additionally and/or alternatively evaluate the impedance measurement based on a number of negative reactance values.

In one particular example, the processing devices evaluate the impedance measurement as being in a first category if a number of negative reactance measurements exceed a first category reactance threshold or at least one parameter value has an error greater than a respective first category threshold. Similarly the processing device determines an impedance measurement to be in a second category if a number of negative reactance measurements exceed a second category reactance threshold or each parameter value has an error greater than a respective second category threshold. If the measurement is not in the first or second categories, it is then classified in a third category. In this example, the first category corresponds to a bad measurement, the second to a questionable measurement and the third category to an acceptable measurement.

As a further refinement, the processing devices evaluate the impedance measurement as being in the first category if an R<NUM> error is greater than a first category R<NUM> threshold, or in a second category if an Ri error is greater than a first category Ri threshold or an Rinf error is greater than a first category Rinf threshold.

In the above examples, a deviation is used to determine errors in impedance parameter values, which are then compared to respective thresholds to determine if impedance measurements are acceptable. However, as an alternative approach, the processing devices can evaluate the measurement using at least one computational model embodying a relationship between different deviations and measurement validity. In this instance, the computational model can be obtained by applying machine learning to deviations and assessments of measurement validity obtained from one or more reference subjects.

Thus, machine learning can be used to analyse deviations, and an assessment of whether the deviations are acceptable, with this being used to develop a computational model that can perform assessments based on the deviation directly. Using this approach, the deviation could be assessed in a wide range of manners, and take into account a wide range of different factors, potentially leading to a more accurate assessment.

As mentioned above, a phase correction can be applied to impedance values measured at a frequency higher than a set frequency, with the impedance curve being calculated using the phase corrected impedance values. The manner in which phase correction is performed is generally known and will be described in more detail below.

The above described techniques can be used for impedance measurements used to calculate parameter values, which can then be used to determine a body state value, which could be indicative of a specific condition, or could be a general indication of a measured body parameter value that is in turn indicative of a condition. Examples include, but are not limited to one or more of Body Composition, Dry Lean Mass, Lean Body Mass, Skeletal Muscle Mass, Segmental Lean Analysis, Body Fat Mass, Segmental Fat Analysis, BMI (Body Mass Index), (Percent Body Fat), Visceral Fat Area, Visceral Fat Level, Total Body Water (TBW), Intracellular Water (ICW), Extracellular Water (ECW), ECW/TBW, Segmental Body Water, Segmental ECW/TBW, Segmental ICW Analysis, Segmental ECW Analysis, Body-Fat-LBM Control, BMR (Basal Metabolic Rate), Leg Lean Mass, TBW/LBM, Whole Body Phase Angle, Segmental Phase Angle, Reactance, Impedance of Each Segment per frequency, or Body Water Composition History. The body state could also be indicative of a general level of health or athletic fitness, such as whether the individual is fit or unfit.

In one example, the processing device generates an indicator indicative of the body state value, with the indicator being displayed as part of a representation on a display, such as a client device screen, as will be described in more detail below. Thus, results could be presented as a graphical representation, for example using a pointer and scale to indicate the magnitude and/or changes in the indicator value.

In addition to the above techniques, or as an alternative, evaluation of the impedance measurements can also be performed in accordance with other criteria.

In one example, evaluation can be performed based on the number of impedance values that have a negative reactance value. In this regard, negative reactance values typically result from a poor measurement, for example arising due to poor surface contact between the subject and the electrode. Accordingly, a high percentage of negative reactance values is indicative of a poor measurement.

In this example, the technique typically includes having the one or more processing devices determine a count of impedance values having negative reactance values and then using the count to perform an evaluation of the impedance measurements.

This could be achieved in any appropriate manner, and could include applying a phase correction to impedance values measured at a frequency higher than a set frequency; and then determining the count using the phase corrected impedance values.

In one example, the processing device evaluates the impedance measurement as being in a first category if the count is greater than <NUM>% of a total number of impedance values or in a second category if the count is greater than <NUM>%, although it will be appreciated that these thresholds could be adjusted and are intended to be illustrative only. For example, the first category threshold could be greater than <NUM>%, greater than <NUM>%, greater than <NUM>% or greater than <NUM>%, whereas the second category threshold could be greater than <NUM>%, greater than <NUM>%, greater than <NUM>% or greater than <NUM>%.

In another example, a difference between an impedance parameter value and a measured impedance value could be used to evaluate the impedance measurements. For example, if the difference in values is greater than a certain amount, this could be indicative of an unduly broad variance in the impedance values.

In this example, the processing device typically calculates an impedance parameter value using the impedance values, compares the impedance parameter value to a defined frequency impedance value, the defined frequency impedance value being determined from an impedance value obtained by from impedance measurements performed at a defined measurement frequency and then uses a result of the comparison to perform an evaluation of the impedance measurements.

Different parameter values could be used, in which case different defined frequency impedance value would be used.

For example, the parameter value could R<NUM>, which case the defined frequency impedance value is typically an impedance value measured at a low frequency, such as greater than <NUM>, but less than less than <NUM>, less than <NUM>, or less than <NUM>. In one example, the frequency is between <NUM> and <NUM> and is typically about <NUM>.

In another example, the parameter value is Rinf which is the theoretical impedance at an infinite frequency, in which case the defined frequency impedance value is typically an impedance value measured at a high frequency, such as greater than <NUM>, greater than <NUM>, less than <NUM>, less than <NUM>, or less than <NUM>. In one example, the defined frequency impedance value is measured at between <NUM> and <NUM> and is typically about <NUM>.

As a further alternative, the parameter value is a theoretical impedance at the defined frequency. Thus, in this instance, an impedance measurement performed at a specific frequency (e.g. at <NUM>) can be compared to an impedance parameter value in the form of an impedance value obtained from the fitted curve at the same frequency.

In these examples, the processing device can evaluate the impedance measurement as being in a first category if a magnitude of the difference between the impedance parameter value and the defined frequency impedance value is greater than a first difference threshold, or in a second category if a magnitude of the difference between the impedance parameter value and the defined frequency impedance value is greater than a second difference threshold but below the first difference threshold.

It will be appreciated that these difference thresholds could be adjusted depending on the preferred implementation and/or the level of accuracy required by the particular impedance measurements and the defined frequency and parameter value.

The difference thresholds could be absolute. For example, if the impedance parameter value is R<NUM> the first difference threshold could be <NUM>Ω, whereas the second difference threshold could be <NUM>Ω, whereas if the impedance parameter value is Rinf the first difference threshold could be <NUM>Ω, whereas the second difference threshold could be <NUM>Ω.

However, this is not essential, and alternatively, the difference thresholds could be relative, and may for example be set based on a percentage of the impedance parameter value. Thus, in this example, if the impedance parameter value is R<NUM> the first difference threshold could be <NUM>%, whereas the second difference threshold could be <NUM>%, whereas if the impedance parameter value is Rinf the first difference threshold could be <NUM>%, whereas the second difference threshold could be <NUM>%.

Example equations used in calculating the magnitude of the difference are shown below: <MAT> <MAT>.

It will be appreciated from this that a range of different difference thresholds could be used depending on the preferred implementation, the nature of the measurement system and the defined frequency and parameter values.

Although not essential, in one example, the above described process is implemented using a distributed architecture including one or more measuring systems in communication with one or more processing devices. An example system will now be described with reference to <FIG>.

In this example, the system <NUM> includes a number of measuring systems <NUM> coupled via a communications network <NUM> to one or more other measuring systems <NUM> and/or one or more processing devices, such as a server <NUM>, which may in turn be coupled to a database <NUM>. This arrangement allows data from performed measurements to be collected by the measurement systems <NUM> and provided to the server <NUM> for analysis. Collected data may also be stored in the database <NUM> together with resulting reference signatures and/or heart failure indicators, allowing this information to be remotely accessed and viewed by third parties, such as clinicians, or the like.

In the above arrangement, the communications network <NUM> can be of any appropriate form, such as the Internet and/or a number of local area networks (LANs) and provides connectivity between the measuring systems <NUM> and the server <NUM>. It will however be appreciated that this configuration is for the purpose of example only, and in practice the measuring systems <NUM> and server <NUM> can communicate via any appropriate mechanism, such as via wired or wireless connections, including, but not limited to mobile networks, private networks, such as an <NUM> network, the Internet, LANs, WANs, or the like, as well as via direct or point-to-point connections, such as Bluetooth, or the like.

It will also be noted that the use of the distributed system is purely optional and the process can be implemented using a standalone measuring system.

An example measuring system will now be described in further detail with reference to <FIG>.

In this example, the measuring system includes an impedance measuring unit having an impedance measuring device <NUM>, which is in turn in communication with a processing system in the form of a client device <NUM>, such as a portable computer system, mobile phone, tablet or the like. One or more optional physical characteristic sensors <NUM> can also be provided for capturing information regarding physical characteristics of an individual/subject.

The nature of the physical characteristic sensors <NUM> will vary depending on the characteristics to be measured, and could include for example scales for measuring an individual/subject's weight and/or an image capture device, such as a camera, body scanner, DEXA (Dual-Energy X-ray Absorptiometry), 3D laser or optical scanning, or the like, for measuring a height and/or body segment dimensions, as will be described in more detail below. Additionally or alternatively, this could include electronic scales for measuring a weight, and other monitoring equipment, for example for measuring heart rate, blood pressure or other characteristics.

The impedance measuring device <NUM> typically includes a measuring device processor <NUM> coupled to at least one signal generator <NUM> and at least one sensor <NUM>, which are in turn coupled to respective drive and sense electrodes <NUM> and <NUM>, via leads <NUM>. In use, the signal generator <NUM> generates a drive signal, which is applied to the individual/subject S via the drive electrodes <NUM>, whilst the sensor <NUM> measures a response signal via the sense electrodes <NUM>. In use, the measuring device processor <NUM> controls the at least one signal generator <NUM> and the at least one sensor <NUM>, allowing the impedance measurements to be performed.

In particular, the measuring device processor <NUM> is adapted to generate control signals, which cause the signal generator <NUM> to generate one or more alternating signals, such as voltage or current signals of an appropriate waveform, which can be applied to a subject S, via the first electrodes <NUM> and processing received signals from the sensor <NUM>. It will be appreciated that the measuring device processor <NUM> may be any form of electronic processing device capable of performing appropriate control, and could include an FPGA (field programmable gate array), or a combination of a programmed computer system and specialised hardware, or the like.

The signal generator <NUM> could be of any appropriate form, but will typically include digital to analogue converters (DACs) for converting digital signals from the processing device to analogue signals, which are amplified to generate the required drive signals, whilst the sensor <NUM> typically includes one or more amplifiers for amplifying sensed response signals and analogue to digital converters (ADCs) to digitise the analogue response signals and providing digitised response signals to the processing device.

The nature of the alternating drive signal will vary depending on the nature of the measuring device and the subsequent analysis being performed. For example, when performing Bioimpedance Spectroscopy (BIS), impedance measurements are performed at each of a number of frequencies ranging from very low frequencies (<NUM> and more typically <NUM>) to higher frequencies (<NUM>), and can use as many as <NUM> or more different frequencies within this range. Such measurements can be performed by applying a signal which is a superposition of plurality of frequencies simultaneously, or a number of alternating signals at different frequencies sequentially, depending on the preferred implementation. The frequency or frequency range of the applied signals may also depend on the analysis being performed.

When impedance measurements are made at multiple frequencies, these can be used to derive one or more impedance parameter values, such as values of R0, Zc, R∞, which correspond to the impedance at zero, characteristic and infinite frequencies. These can in turn be used to determine information regarding both intracellular and extracellular fluid levels, as will be described in more detail below.

A further alternative is for the system to use Multiple Frequency Bioimpedance Analysis (MFBIA) in which multiple signals, each having a respective frequency are injected into the subject S, with the measured impedances being used in the assessment of fluid levels. In one example, four frequencies can be used, with the resulting impedance measurements at each frequency being used to derive impedance parameter values, for example by fitting the measured impedance values to a Cole model, as will be described in more detail below. Alternatively, the impedance measurements at each frequency may be used individually or in combination.

Thus, the measuring device <NUM> may either apply an alternating signal at a single frequency, at a plurality of frequencies simultaneously, or a number of alternating signals at different frequencies sequentially, depending on the preferred implementation. The frequency or frequency range of the applied signals may also depend on the analysis being performed.

In one example, the applied signal is generated by a voltage generator, which applies an alternating voltage to the subject S, although alternatively current signals may be applied. In one example, the voltage source is typically symmetrically arranged, with two signal generators <NUM> being independently controllable, to allow the signal voltage across the subject to be varied, for example to minimise a common mode signal and hence substantially eliminate any imbalance as described in copending patent application number <CIT>.

As the drive signals are applied to the subject, the sensor <NUM> then determines the response signal in the form of the voltage across or current through the subject S, using second electrodes <NUM>. Thus, a voltage and/or current is measured between the second electrodes <NUM>. In one example, a voltage is measured differentially, meaning that two sensors <NUM> are used, with each sensor <NUM> being used to measure the voltage at each second electrode <NUM> and therefore need only measure half of the voltage as compared to a single ended system. Digitised response signals are then provided to the measuring device processor <NUM>, which determines an indication of the applied drive signal and measured response signals, and optionally uses this information to determine measured impedances.

In the above arrangement, four electrodes are shown, with two forming drive electrodes and two forming sense electrodes. However, this is not essential, and any suitable number of electrodes could be used. Furthermore, a single signal generator and sensor are shown, but again a respective signal generator and sensor could be used for each drive and sense electrode, respectively, and the described arrangement is for the purpose of illustration only.

The four electrode arrangement allows a number of different measures to be performed, depending on the configuration of the electrodes. For example, the configuration shown in <FIG> can then be used to allow torso measurements to be performed, whilst the configurations shown in <FIG> can be used to allow right whole of body, right arm, right leg and left torso to be measured respectively.

A further example of a physical construction of the measuring device is shown in <FIG>.

In this example, the measuring device includes first and second housings <NUM>, <NUM>. The first housing <NUM> has a form factor similar to a set of scales, and includes a generally rectangular body having two spaced pairs of foot drive and sense electrodes <NUM>, <NUM> formed from spaced apart metal plates provided on an upper surface, thereby forming footplates on which a user can stand. The second housing <NUM> has a generally rectangular body having two spaced pairs of hand drive and sense electrodes <NUM>, <NUM> formed from spaced apart metal plates provided on an upper surface, thereby forming handplates on which a user can rest their hands.

The first housing <NUM> includes a raised section <NUM>, defining a lip <NUM> extending at least partially around each pair of foot drive and sense electrodes to thereby guide positioning of a subject's foot relative to the foot drive and sense electrodes in use. In particular, the raised lip <NUM> includes a rear portion <NUM> configured to engage at least a heel of the user. A similar effect is achieved for the second housing by having a raised portion <NUM> positioned between each pair of hand drive and sense electrodes, the raised portion defining thumb recesses <NUM> to thereby guide positioning of a subject's thumbs, with the crook of the thumb engaging the raised portion, and hence hands relative to each pair of hand drive and sense electrodes in use.

In this regard, it will be appreciated that whilst this will still allow for some minor variation in positioning between different individuals, for example due to different feet and hand sizes, this helps ensure that any given user's hands and feet are provided at a consistent position relative to the drive and sense electrodes each time the apparatus is used. This provides reproducible positioning, which in turn reduces variations between successive measurements that could be caused by changes in hand or foot position.

This arrangement allows the unit to be used by having the user stand on the first housing, or alternatively sit on a chair, with their feet resting on the foot drive and sense electrodes. The user can then place their hands on the hand drive and sense electrodes on second housing, which can be supported by a desk or table in a seated arrangement, or by a stand or other support for a standing arrangement.

The use of two housing containing separate electrodes, therefore allows impedance measurements to be performed in a variety of circumstances, and in particular allows measurements to be performed in either seated or standing arrangements, which is important in ensuring the system can be used by individuals having restricted physical capabilities. Additionally, the use of metal plate electrodes provided in a housing allows the system to be readily used, and avoids the need for preparation, such as cleaning of tissue surfaces or removal of hair, to allow wet electrodes to be applied to the skin.

It will be appreciated that in this arrangement, electrode configurations similar to those described above with respect to <FIG> can be achieved by selectively using respective ones of the drive and sense electrodes <NUM>, <NUM>, <NUM>, <NUM>.

In the above arrangement, the client device <NUM> is in communication with the measuring device processor <NUM>, typically via a wireless communications channels, such as Bluetooth or the like. In one example, the client device <NUM> is provided in a stand, which is then attached to mounting <NUM>, allowing the client device <NUM> to be supported on the apparatus in use. This allows the client device <NUM> to act as a user interface, allowing operation of the impedance measuring device to be controlled, and allowing results of impedance measurements to be displayed.

In particular, the client device <NUM> can be used to instruct the measuring device processor <NUM> on a particular sequence of impedance measurements that need to be performed, further receiving either an indication of the drive/sense signals and/or measured impedance values. The client device <NUM> can then optionally perform further processing, for example to determine the impedance indicators, although alternatively this may not be required and raw impedance values could be provided to the server <NUM> for analysis.

The client device <NUM> can also combine impedance values or indicators with information regarding indications of heart failure states and physical characteristics determined either by manual user input or based on signals from one or more physical characteristic sensors. This allows the client device to generate the reference data, which is then transferred via the communications network <NUM> to the server <NUM>. However, alternatively, the server <NUM> could obtain the indication of heart failure states and/or physical characteristic from other data sources, depending on the preferred implementation.

Accordingly, it will be appreciated that the client device <NUM> can be of any appropriate form and one example is shown in <FIG>. In this example, the client device <NUM> includes at least one microprocessor <NUM>, a memory <NUM>, an input/output device <NUM>, such as a keyboard and/or display, and an external interface <NUM>, interconnected via a bus <NUM> as shown. The external interface <NUM> can be utilised for connecting the client device <NUM> to peripheral devices, such as the communications networks <NUM>, databases, other storage devices, or the like. Although a single external interface <NUM> is shown, this is for the purpose of example only, and in practice multiple interfaces using various methods (eg. Ethernet, serial, USB, wireless or the like) may be provided.

In use, the microprocessor <NUM> executes instructions in the form of applications software stored in the memory <NUM> to allow communication with the server <NUM>, for example to allow reference data to be provided to the sever, or the like.

Accordingly, it will be appreciated that the client device <NUM> may be formed from any suitable processing system, such as a suitably programmed PC, Internet terminal, lap-top, or hand-held PC, and in one preferred example is either a tablet, or smart phone, or the like. Thus, in one example, the client device <NUM> is a standard processing system such as an Intel Architecture based processing system, which executes software applications stored on non-volatile (e.g., hard disk) storage, although this is not essential. However, it will also be understood that the client devices <NUM> can be any electronic processing device such as a microprocessor, microchip processor, logic gate configuration, firmware optionally associated with implementing logic such as an FPGA (Field Programmable Gate Array), or any other electronic device, system or arrangement.

An example of a suitable server <NUM> is shown in <FIG>. In this example, the server includes at least one microprocessor <NUM>, a memory <NUM>, an optional input/output device <NUM>, such as a keyboard and/or display, and an external interface <NUM>, interconnected via a bus <NUM> as shown. In this example the external interface <NUM> can be utilised for connecting the server <NUM> to peripheral devices, such as the communications networks <NUM>, databases <NUM>, other storage devices, or the like. Although a single external interface <NUM> is shown, this is for the purpose of example only, and in practice multiple interfaces using various methods (eg. Ethernet, serial, USB, wireless or the like) may be provided.

In use, the microprocessor <NUM> executes instructions in the form of applications software stored in the memory <NUM> to allow the required processes to be performed, including communicating with the client devices <NUM>, and optionally receiving, analysing and/or displaying results of impedance measurements. The applications software may include one or more software modules, and may be executed in a suitable execution environment, such as an operating system environment, or the like.

Accordingly, it will be appreciated that the server <NUM> may be formed from any suitable processing system, such as a suitably programmed client device, PC, web server, network server, or the like. In one particular example, the server <NUM> is a standard processing system such as an Intel Architecture based processing system, which executes software applications stored on non-volatile (e.g., hard disk) storage, although this is not essential. However, it will also be understood that the processing system could be any electronic processing device such as a microprocessor, microchip processor, logic gate configuration, firmware optionally associated with implementing logic such as an FPGA (Field Programmable Gate Array), or any other electronic device, system or arrangement. Accordingly, whilst the term server is used, this is for the purpose of example only and is not intended to be limiting.

Whilst the server <NUM> is a shown as a single entity, it will be appreciated that the server <NUM> can be distributed over a number of geographically separate locations, for example by using processing systems and/or databases <NUM> that are provided as part of a cloud based environment. Thus, the above described arrangement is not essential and other suitable configurations could be used.

However, it will be appreciated that the above described configuration assumed for the purpose of the following examples is not essential, and numerous other configurations may be used. It will also be appreciated that the partitioning of functionality between the measuring device <NUM>, client devices <NUM>, and servers <NUM> may vary, depending on the particular implementation.

Operation of the system will now be described in further detail with reference to <FIG>.

Throughout the following example reference will be made to a user. In this regard, the user will generally be understood to include the subject, but may also encompass an individual assisting the subject in performing the measurement, such as a medical practitioner or the like.

For the purpose of these examples it will also be assumed that a user uses the client device <NUM> to control the measuring device <NUM> and optionally any characteristics sensors, allowing impedance measurements to be performed and optionally allowing information regarding physical characteristics to be collected. This is typically achieved by having the user interact with the system via a GUI (Graphical User Interface), or the like presented on the client device <NUM>, which may be generated by a local application, or hosted by the server <NUM>, which is typically part of a cloud based environment, and displayed via a suitable application, such as a browser or the like, executed by the client device <NUM>. Actions performed by the client device <NUM> are typically performed by the processor <NUM> in accordance with instructions stored as applications software in the memory <NUM> and/or input commands received from a user via the I/O device <NUM>. Similarly, actions performed by the server <NUM> are performed by the processor <NUM> in accordance with instructions stored as applications software in the memory <NUM> and/or input commands received from a user via the I/O device <NUM>, or commands received from the client device <NUM>.

In this example, at step <NUM>, the measuring device processor <NUM> determines the impedance measurement to be performed. This can be achieved in any suitable manner, but would typically include having the user selecting one of a number of available measuring procedures presented on the client device <NUM>, with the client device <NUM> generating instructions which are provided to the measuring device processor <NUM>.

Prior to a measurement being performed, the first and second electrodes <NUM>, <NUM> are provided in contact with the subject to allow one or more signals to be injected into the subject S, and allowing a response signal to be measured. The location of the electrodes <NUM>, <NUM> will depend on the segment of the subject S under study. Thus, for example, the electrodes <NUM>, <NUM> can be placed on the thoracic and neck region of the subject S to allow the impedance of the chest cavity to be determined. Alternatively, positioning electrodes on the wrist and ankles of a subject allows the impedance of limbs, torso and/or the entire body to be determined. In one example, the general arrangement is to provide electrodes on the hand at the base of the knuckles and between the bony protuberances of the wrist, and on the feet at the base of the toes and at the front of the ankle.

In the arrangement of <FIG>, prior to the measurement being performed the subject stands on the first housing <NUM>, or alternatively sits on a chair, with their feet resting on the foot drive and sense electrodes <NUM>, <NUM>. The user then places their hands on the hand drive and sense electrodes <NUM>, <NUM> on the second housing <NUM>, which can be supported by a desk or table in a seated arrangement, or by a stand or other support for a standing arrangement.

At step <NUM>, the measuring device processor <NUM> controls the signal generator and sensor, causing the drive signals to be applied to the individual/subject and causing the corresponding response signals to be measured, allowing the measuring device processor <NUM> to determine both the drive and response signals at step <NUM>.

In this regard, the response signal will be a superposition of voltages generated by the human body, such as the ECG (electrocardiogram), voltages generated by the applied signal, and other signals caused by environmental electromagnetic interference. Accordingly, filtering or other suitable analysis may be employed to remove unwanted components.

The acquired signal is typically demodulated to obtain the impedance of the system at the applied frequencies. One suitable method for demodulation of superposed frequencies is to use a Fast Fourier Transform (FFT) algorithm to transform the time domain data to the frequency domain. This is typically used when the applied current signal is a superposition of applied frequencies. Another technique not requiring windowing of the measured signal is a sliding window FFT.

In the event that the applied current signals are formed from a sweep of different frequencies, then it is more typical to use a signal processing technique such as multiplying the measured signal with a reference sine wave and cosine wave derived from the signal generator, or with measured sine and cosine waves, and integrating over a whole number of cycles. This process, known variously as quadrature demodulation or synchronous detection, rejects all uncorrelated or asynchronous signals and significantly reduces random noise.

Other suitable digital and analogue demodulation techniques will be known to persons skilled in the field.

At step <NUM>, the drive and response signals are used to determine impedance values. This can be performed by the measuring device <NUM> alone, or can be performed in conjunction with the client device <NUM>, for example by transferring measured current and voltage signals to the client device <NUM>, which then analyses these to determine the measured impedances.

In the case of BIS, impedance or admittance measurements are determined from the signals at each frequency by comparing the recorded voltage and the current through the subject. The demodulation algorithm can then produce amplitude and phase signals at each frequency, allowing an impedance value at each frequency to be determined.

The above described process can be performed multiple times, for example to allow impedance measurements to be determined for multiple body segments, including the torso and one or more other segments, such as limbs. Additionally or alternatively, the process may be performed multiple times for the same body segment, with an average (or other statistical measure, such as median, mode, or the like) of two or more measurements being determined and, for example, used for further analysis.

At step <NUM>, a phase correction is typically determined.

In this regard, BIS measurements on human subjects do not usually show the clean circular arc predicted by the complex impedance model, for a number of reasons including electrical contact issues, subject movement and so on, some of which can be addressed by good measurement procedures. However, one source of error which is difficult to avoid is capacitive leakage, which is especially prevalent at higher frequencies. Because of the physical size of the human body, there is inevitable capacitive coupling between different parts of the body and to the surroundings, which means that some of the current does not pass through the body but bypasses it through the air so that the impedance of the subject in parallel with a capacitor is being measured. The effect on the measurements is generally an increase in reactance at high frequencies, and an example of this is shown in <FIG>, which compare a perfect complex impedance plot and a more typical measurement.

Some measurement systems address this by compensation schemes in the analogue circuitry, but if the coupling for any given patient differs from the amount of compensation, there will be a residual increase or decrease in reactance, or sometimes negative reactances. As an alternative, this can be compensated for in software during data analysis, and the most common approach is to apply a phase correction to the raw data, with each measured impedance having a phase correction applied which is proportional to the frequency. This is in turn equivalent to applying a fixed time delay offset to the data set, and so is commonly referred to as a Td correction, although it will be appreciated that a true capacitive shunt model correction would be also an appropriate scheme. The effect of a Td correction is shown in <FIG>.

The best value of phase correction to apply to the raw data is obtained by using the relationship between the U/V ratio and frequency. Specifically, the value of the phase correction is adjusted iteratively until the relationship is the closest to a straight line. The regression coefficient is used as a measure, and its absolute value should be as close as possible to <NUM>.

Example U/V plots for the measurement example shown in <FIG> are shown in <FIG>, respectively. <FIG> shows a U/V plot for the original data, whilst <FIG> shows optimum phase correction, and <FIG> showing too much phase correction. Thus, it will be appreciated that the phase correction value can be iteratively determined, until the U/V plot is sufficiently close to a straight line.

In this regard, the process typically includes determining a trial phase correction, applying this to the measured impedance values and calculating the impedance curve. The impedance curve is used to derive the U/V correlation coefficient, with this process being repeated iteratively for different phase correction values until the correlation coefficient reaches a sufficient value.

Since phase correction only affects the high frequency data, and sometimes there may be artefacts at the low frequency part of the spectrum, the optimisation is typically only performed on approximately the upper three quarters of the measurement data (equivalent to frequencies over about <NUM>).

Once the phase correction is calculated, this is applied to the impedance measurements using the equation: <MAT>.

After correction corrected values of R' and Xc' are calculated from: <MAT> <MAT>.

The corrected data, ϕ', R' and Xc' are used in all analysis with the original |Z| instead of ϕ, R and Xc.

At step <NUM>, the circular arc is calculated for the phase corrected data, which uses an equation of the form: <MAT>.

The equation for a circle with a centre at (a, b) and radius r is: <MAT>.

Given a set of x and y values this this is solvable by multiple linear regression, as it is of the correct form, where: <MAT>.

Substituting resistance, R for x and Reactance X for y, the circle equation becomes: <MAT>.

Observing that with the impedance values, Z<NUM> = R<NUM> + X<NUM>, the circle equation can be written as: <MAT>.

The values of m, p and q can be found by multiple linear regression and yield the arc centre and radius, using the regression formulae: <MAT>.

The arc centre (a, b) and radius r can be found from m, p and q.

Values for R<NUM>, R∞ and α can then be obtained by simple trigonometry: <MAT> <MAT> <MAT>.

In some cases it may be desirable to restrict the frequency range of data used in the curve fitting to avoid unwanted high and low frequency effects. This is controlled by setting maximum and minimum frequencies, between which data is used and outside which data is ignored.

The raw resistance and reactance data is fit to the equation of a circle using multiple linear regression, resulting in the fitted solution for the centre of the circle (a,b) and the radius of the circle (r) as functions of m, p and q. <MAT> <MAT> <MAT> <MAT>.

Equivalently: <MAT> where: <MAT> <MAT> <MAT> <MAT> <MAT> <MAT> <MAT> where F = no of frequencies.

R<NUM> and Rinf can be calculated from the fitted solution (m,p,q) when reactance equals zero (y = <NUM>). <MAT> <MAT> <MAT> <MAT> <MAT>.

Using the solution to a second order polynomial, R<NUM> and Rinf are calculated. <MAT> <MAT>.

The equation of a circle can be rewritten in matrix form: <MAT> where: <MAT> <MAT> <MAT>.

At step <NUM>, an estimated error of the solution x = [p,q,r]T due to the linear least squares fit is calculated, with this being used to estimate a co-variance matrix at step <NUM>, which contains the variances and co-variances associated with each variable, with the variance being equal to the square of the standard deviation. This can then be used to determine the standard deviation of each variable.

The least linear square solution for the previous equation is calculated by: <MAT>.

And the covariance matrix is determined by: <MAT> Where: <MAT> can be determined by the mean square error of the fit.

At step <NUM>, the error is propagated from one set of variables (m, p, q) to another (R<NUM>, Rinf; Ri), which can be calculated using the Jacobian transform along with the covariance matrix as follows.

The Jacobian is the matrix of all first order partial derivatives of a vector valued function and is an indication of how one system is converted to another. The Jacobian for this solution is calculated by: <MAT> <MAT> <MAT> <MAT>.

The uncertainty in the impedance parameters are then calculated as follows: <MAT> <MAT> <MAT> <MAT> <MAT> <MAT>.

At step <NUM> one or more thresholds can be retrieved. As previously described, the thresholds could be default generic thresholds, or could be customised for the current subject. In one example, the thresholds are set based on physical characteristics of the user, and may take into account the particular impedance measurement process being performed, for example if the impedance measurement forms part of a body composition assessment, as opposed to a lymphedema assessment, or the like.

At step <NUM>, the error(s) calculated as described above are compared to the thresholds to determine if the thresholds are exceeded. Additionally, at step <NUM>, a number of negative reactance values can be calculated, specifically to determine a count of impedance values having a negative reactance value as a proportion of a total number of impedance values, with these being compared to respective thresholds at step <NUM>.

At step <NUM>, impedance parameter values are calculated, with these then being compared to impedance measurements performed at specific frequencies at step <NUM>. In one example, the parameter value corresponds to R<NUM>, with this being compared to the phase corrected impedance value determined based on an impedance measured performed at <NUM>. This is used to calculate a magnitude of the distance between the impedance value and the parameter value, as given by the equation: <MAT>.

Similarly, the parameter value could be Rinf with this being compared to the phase corrected impedance value determined based on an impedance measured performed at <NUM>. This is used to calculate a magnitude of the distance between the impedance value and the parameter value, as given by the equation: <MAT>.

The results of the comparison are then evaluated at step <NUM>, with this being used to evaluate the measurement, and in one particular example, place the measurement into one of three categories, in this example designated as red, yellow or green, corresponding to measurements that are bad, questionable or acceptable.

An example of the particular assessment criteria are shown below:.

It will be appreciated that the actual values of the thresholds will depend on the impedance measuring device used, and that these can be set based on a visual evaluation of example measurements.

At step <NUM>, the evaluation is displayed to a user, allowing the user to make an assessment of whether or not the measurement is to be accepted, which is typically indicated via user input provided via the user interface at step <NUM>.

The feedback can be used to optionally update the thresholds at step <NUM>. For example, if a measurement was categorised as red or yellow, but ultimately accepted by the user, this can be used to update thresholds for the respective subject, so that the categorisation becomes more accurate over time.

If the measurement was not accepted, the process can return to step <NUM> allowing the measurement to be repeated.

Otherwise the measurements can be used to determine an indicator, such as a body composition indicator or similar at step <NUM>.

In the above example, the errors in the impedance parameter values are used individually in order to categorise the impedance measurement as red, yellow, or green. However, it will be appreciated that other assessments could be made. For example, the errors could be combined to calculate an overall error across the impedance parameter values, with the overall error being used in making the assessment. Such a combination could be performed using a simple summation of errors, or could be calculated in other manners, such as using a weighted sum, overall percentage error, or the like. Additionally, whilst the above example operates by categorizing the measurements, it will be appreciated that other evaluations could be used, such as calculating an overall confidence score, or the like.

The above example also uses multiple linear regressions in order to perform the curve fitting, but will be appreciated that other linear or non-linear approaches can be used, which can in turn simply include calculation of the Jacobian. It will also be appreciated that whilst the above described example has focussed on calculation of the Jacobian matrix for the impedance parameter values R<NUM>, Rinf and Ri, the technique could be extended to other impedance parameter values that can be calculated from the impedance curve, such as α, or the like.

The above described approach can be used for a wide range of different parameters, but are particularly suited to measurements of fluid levels, which are often subject to a wide range of variations based on external factors and day to day variations, which are not otherwise necessarily meaningful.

Furthermore, whilst the above examples have focussed on a subject such as a human, it will be appreciated that the measuring device and techniques described above can be used with any animal, including but not limited to, primates, livestock, performance animals, such race horses, or the like.

Claim 1:
An impedance measurement system for performing a bioimpedance measurement on a biological subject, the system including:
a) a signal generator configured to apply alternating signals to at least part of the biological subject at a plurality of different frequencies;
b) a sensor configured to measure response signals from the biological subject; and,
c) one or more electronic processing devices that:
i) determine the bioimpedance measurement as a plurality of impedance values obtained at the plurality of different frequencies using the measured response signals;
ii) calculate an impedance curve using a curve fitting algorithm;
iii) determine a deviation of the impedance curve from the plurality of impedance values of the bioimpedance measurement; and,
iv) use the deviation to perform an evaluation of the bioimpedance measurement characterised in that evaluation of the bioimpedance measurement is used to categorise the bioimpedance measurement and derive an indicator indicative of the measurement categorisation.