Hydration status monitoring

• US 9,724,012 B2
• Filed: 10/10/2006
• Issued: 08/08/2017
• Est. Priority Date: 10/11/2005
• Status: Active Grant

• Current Assignee: ImpediMed Limited
• Original Assignee: ImpediMed Limited
• Inventors: Chetham, Scott
• Primary Examiner(s): Stout, Michael C
• Application Number:
  US12/090,078
• Publication Number:
  US 20090043222A1
• Time in Patent Office: 3,955 Days
• Field of Search: 600576-579
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/4875 Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/4878 Evaluating oedema
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A method of determining an indication of the hydration status relating to a subject. The method includes determining a measured impedance value for at least one body segment, and then; for each body segment, using the measured impedance values to determine at least one indicator at least partially indicative of a level of extracellular fluid. Indicators can then be used to determine an indication of the hydration status.

Claims

1. A method for use in dialysis of a subject, the method including, in a processing system configured to perform the steps of:

a) determining a subject orientation;

b) determining a measured impedance value for at least one body segment;

c) for each body segment, and using the measured impedance values, determining at least a first indicator and a second indicator, the indicators being at least partially indicative of a level of extracellular fluid;

d) determining a difference between the first and second indicators, wherein

the first indicator is determined when the subject is in a first orientation, the second indicator is determined when the subject is in a second orientation, and the first and second orientations are different;

e) monitoring changes in the difference over time, the difference being indicative of hydration status of the subject;

comparing the changes in the difference to a threshold; and

,

selectively controlling the dialysis of the subject using the results of the comparison, wherein selectively controlling the dialysis includes halting the dialysis when the changes in the difference fall below the threshold.

2. A method according to claim 1, wherein the reference includes at least one of:

a) a predetermined threshold;

b) a tolerance determined from a normal population;

c) a predetermined range; and

,

d) an indicator previously determined for the subject.

3. A method according to claim 1 wherein the indicator is at least one of:

a) an index (I) of the ratio of extra- to intra-cellular fluid; and

,

b) an extracellular fluid volume.

4. A method according to claim 1 wherein the method includes, in the processing system:

a) determining a plurality of measured impedance values for each body segment, each measured impedance value being measured at a corresponding measurement frequency; and

,

b) determining impedance parameter values based on the plurality of measured impedance values, the indicator being at least partially based on the determined impedance parameter values.

5. A method according to claim 4, wherein the parameter values include R₀ and R_∞

wherein;

R₀ is the resistance at zero frequency; and

,

R_∞

is the resistance at infinite frequency.

6. A method according to claim 5, wherein the method includes:

a) monitoring changes over time for at least one of;

i) R₀;

ii) R_∞

;

iii) a difference between R₀ and R_∞

;

b) a vector indication of an impedance measurement.

7. A method according to claim 5, wherein the method includes, in the processing system:

a) determining values for parameters R₀ and R_∞

from the measured impedance values; and

b) determining the indicator by calculating the index (I) using the equation;

8. A method according to claim 5, wherein the method includes, in the processing system, determining the parameter values using the equation:

9. A method according to claim 8, wherein the method includes, in the processing system:

a) determining the impedance of each body segment at four discrete frequencies; and

,

b) determining values for the parameters by solving the equation using four simultaneous equations.

10. A method according to claim 5, wherein the method includes, in the processing system, determining the parameter values by:

a) determining a complex impedance locus using the measured impedance values; and

,

b) using the complex impedance locus to determine the parameter values.

11. A method according to claim 1 wherein the indicator for a body segment is the extracellular fluid volume determined using the equation:

12. A method according to claim 11, wherein the method includes determining an indicator for the entire body the equation:

ECV_Total=2(ECV_arm+ECV_leg)+ECV_trunk.

13. A method according to claim 1 wherein the second body segment and the at least one other body segment are different types of body segment.

14. A method according to claim 1 wherein the body segments are limbs.

15. A method according to claim 14, wherein the body segment includes at least one of:

a) a calf; and

,

b) a bicep.

16. A method according to claim 1, wherein the method includes, in the processing system:

a) determining a correction factor; and

b) determining the hydration status using the correction factor.

17. A method according to claim 16, wherein the correction factor is indicative of at least one of:

a) a subject orientation or posture;

b) a subject skin temperature; and

,

c) a subject ethnicity.

18. A method according to claim 1, wherein the method includes, in the processing system, displaying an indication of at least one of:

a) parameter values;

b) the indicator;

c) an extracellular fluid volume; and

,

d) a ratio of extra-cellular to intra-cellular fluid.

19. A method according to claim 1, wherein the method includes, in the processing system:

a) receiving data representing at least one measured impedance value; and

,

b) generating a representation of the at least one measured impedance value.

20. A method according to claim 19, wherein the method includes, in the processing system:

a) selecting a representation type based on a selected impedance measurement type; and

,

b) generating the representation in accordance with the selected representation type.

21. A method according to claim 19, wherein the representation is in the form of at least one of:

a) a complex impedance plot;

b) an argand diagram;

c) a list of impedance values;

d) a reactance against frequency plot; and

,

e) resistance against frequency plot.

22. A method according to claim 1, wherein the method includes, in the processing system:

a) receiving data representing at least one measured impedance value;

b) processing the at least one measured impedance value to determine at least one impedance parameter; and

,

c) generating a representation of the at least one impedance parameter.

23. A method according to claim 1, wherein the method includes, in the processing system:

a) causing one or more electrical signals to be applied to the subject using a first set of electrodes, the one or more electrical signals having a plurality of frequencies;

b) determining an indication of electrical signals measured across a second set of electrodes applied to the subject in response to the applied one or more signals;

c) determining from the indication and the one or more applied signals, an instantaneous impedance value at each of the plurality of frequencies; and

,

d) determining the indicator using the instantaneous impedance values.

24. A method according to claim 23, wherein the electrodes are positioned in accordance with the theory of equal potentials.

25. A method according to claim 24, wherein the positioning of the electrodes includes:

a) a first current supply electrode positioned on a limb being measured;

b) a second current supply electrode on a second limb on the same lateral side of the subject as the limb being measured;

c) a first voltage electrode positioned on a limb being measured; and

,

d) a second voltage electrode positioned on a third limb contra-lateral to the limb being measured.

26. A method according to claim 1, wherein the processing system is coupled to a measuring device, and wherein the method includes, in the processing system:

a) generating instructions; and

,

b) transferring the instructions to the measuring device, the measuring device being responsive to the instructions to cause the impedance measurements to be performed.

27. A method according to claim 1, wherein the processing system forms part of a measuring device.

28. A method according to claim 25, wherein the measuring device includes at least two channels, each channel being adapted to measure the impedance across a respective body segment, and wherein the method includes, in the processing system, causing at least one impedance measurement to be performed using each channel.

29. A method according to claim 26, wherein the measuring device includes a processor, and wherein the processor is for:

a) receiving the instructions; and

,

b) causing one or more impedance measurements to be performed using the instructions.

30. An apparatus for use in dialysis of a subject, the apparatus including a processing system for:

a) determining a subject orientation;

b) determining one or more impedance values for at least one body segment;

c) for each body segment, and using the measured impedance values, determining at least a first indicator and a second indicator, the indicators being at least partially indicative of a level of extracellular fluid; and

,

d) determining the difference between the first and second indicators wherein

the first indicator is determined when the subject is in a first orientation,

the second indicator is determined when the subject is in a second orientation, and the first and second orientations are different;

e) monitoring changes in the difference over time, the difference being indicative of hydration status of the subject;

f) comparing the changes in the difference to a threshold; and

g) selectively controlling the dialysis of the subject using the results of the comparison, wherein selectively controlling the dialysis includes halting the dialysis when the changes in the difference fall below the threshold.

33. The Apparatus according to claim 30, wherein the apparatus includes:

a) a current supply for generating an alternating current at each of a plurality of frequencies;

b) at least two supply electrodes for applying the generated alternating current to a subject;

c) at least two measurement electrodes for detecting a voltage across the subject; and

,

d) a sensor coupled to the measurement electrodes for determining the voltage, the sensor being coupled to the processing system to thereby allow the processing system to determine the measured impedances.

31. A method for use in dialysis of a subject, the method including, in a processing system configured to perform the steps of:

a) determining a first orientation of the subject;

b) determining a first measured impedance value for at least one body segment;

c) for each body segment, and using the first measured impedance values, determining at least one first indicator, the first indicator being at least partially indicative of a level of extracellular fluid with the subject in the first orientation;

d) determining a second orientation of the subject, wherein the first and second orientations are different;

e) determining a second measured impedance value for the at least one body segment;

f) for each body segment, and using the second measured impedance values, determining at least one second indicator, the second indicator being at least partially indicative of a level of extracellular fluid with the subject in the second orientation; and

g) determining a difference between the first and second indicators;

h) monitoring changes in the difference over time, the difference being indicative of hydration status of the subject;

i) comparing the changes in the difference to a threshold; and

j) selectively controlling the dialysis of the subject using the results of the comparison, wherein selectively controlling the dialysis includes halting the dialysis when the changes in the difference fall below the threshold.

32. An apparatus for use in dialysis of a subject, the apparatus including a processing system configured to perform the steps of:

a) determining a first orientation of the subject;

b) determining a first measured impedance value for at least one body segment;

c) for each body segment, and using the first measured impedance values, determining at least one first indicator, the first indicator being at least partially indicative of a level of extracellular fluid with the subject in the first orientation;

d) determining a second orientation of the subject, wherein the first and second orientations are different;

e) determining a second measured impedance value for the at least one body segment;

f) for each body segment, and using the second measured impedance values, determining at least one second indicator, the second indicator being at least partially indicative of a level of extracellular fluid with the subject in the second orientation; and

g) determining a difference between the first and second indicators;

h) monitoring changes in the difference over time, the difference being indicative of hydration status of the subject;

comparing the changes in the difference to a threshold; and

,

selectively controlling the dialysis of the subject using the results of the comparison, wherein selectively controlling the dialysis includes halting the dialysis when the changes in the difference fall below the threshold.