Thoracic impedance monitor and electrode array and method of use

• US 7,474,918 B2
• Filed: 03/24/2005
• Issued: 01/06/2009
• Est. Priority Date: 03/24/2004
• Status: Expired due to Fees

• Current Assignee: Caldwell Simpson LLC
• Original Assignee: Non-invasive Medical Technologies
• Inventors: Frantz, Ann K., Hamski, Philip
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US11/088,307
• Publication Number:
  US 20050215918A1
• Time in Patent Office: 1,384 Days
• Field of Search: 600/547, 600/587, 600/536, 600/506, 600/437, 600/554
• US Class Current: 600/547
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/4869 Determining body composition
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses

Abstract

A portable thoracic impedance monitor for monitoring thoracic fluid levels, an electrode array assembly having a single linear electrode array lead with first, second, third, and fourth electrodes arranged sequentially and axially along the linear electrode array lead, and a method of use of the thoracic impedance monitor. A measurement of the user'"'"'s thoracic impedance is obtained by connecting the second electrode to the user'"'"'s body at the junction of the clavicles, superior to the sternum, the third electrode to the user'"'"'s body at the xiphoid-sternal junction, and the first and fourth electrodes to the user'"'"'s body substantially along a centerline of the user'"'"'s sternum respectively at a first pre-determined distance above the second electrode and a second predetermined distance below the third electrode, followed by initiating operation of the monitor.

Claims

1. A method of using an electrode array and operably coupled impedance measuring device that comprises an electrode array for use with a physiological electronic monitor used to monitor electrical characteristics of a user'"'"'s body, comprising a single linear electrode array lead including at least first, second, third, and fourth electrodes arranged sequentially and axially along the linear electrode array lead;

a first electrode pad assembly including a body member mounting first and second conductive electrode pads, the first and second conductive electrode pads being spaced apart from one another the first pre-determined distance on the body member and being exposed on one side of the body member for contact with the user'"'"'s body, each electrode pad being coupled with a separate one of the first and second electrodes; and

a display configured to display user impedance determined by the device using the electrode array;

wherein the first and second electrodes are spaced apart a first pre-determined distance by a first portion of the electrode lead and the third and fourth electrodes are spaced apart a second pre-determined distance by a second portion of the electrode lead equal to the first pre-determined distance;

wherein the electrode lead is sufficiently flexible between the second and third electrodes to vary the distance between the second and third electrodes on the user'"'"'s body; and

wherein the second and third electrodes are spaced apart from one another by a third portion of the electrode lead a distance sufficient to at least mount one of the second and third electrodes to any adult user'"'"'s thorax at the junction of adult user'"'"'s clavicles and the other of the second and third electrodes to the user'"'"'s thorax just beyond the user'"'"'s xiphoid-sternal junction away from the clavicles;

the method comprising the steps of;

electrically connecting the second electrode to the user'"'"'s thorax at the junction of the clavicles, superior to the sternum, the third electrode to the user'"'"'s thorax proximal the xiphoid-sternal junction, the first electrode to the user'"'"'s body substantially along a centerline of the user'"'"'s sternum at the first pre-determined distance above the second electrode and the fourth electrode to the user'"'"'s thorax substantially along the centerline of the user'"'"'s sternum at the second predetermined distance below the third electrode;

applying a sinusoidal current from the impedance measuring device to the first and fourth electrodes and detecting a differential electrical potential between the second and third electrodes with the impedance measuring device;

determining thoracic impedance of the user from the detected differential electrical potential;

displaying a numerical value of determined thoracic impedance on the display of the impedance measuring device;

wherein the detecting step comprises the steps of differentially amplifying and low pass filtering voltages from the second and third electrodes; and

wherein the calculating step comprises the steps of sampling the differentially amplified and low pass filtered thoracic voltage from the second and third electrodes at predetermined intervals for a number of times, adding the sampled thoracic voltages to generate a sum, dividing the sum by the number of times to provide an averaged thoracic voltage value;

scaling the averaged thoracic voltage value and combining the scaled averaged thoracic voltage value with a predetermined offset value to generate a numerical value of the differential thoracic impedance.

2. The method of claim 1 wherein the method further comprises the step of displaying the numerical value of the differential thoracic impedance on the display, the numerical value of the differential thoracic impedance being the only numerical value displayed on the display.

3. The method of claim 2 comprising the step of selecting as the user, a person suffering from chronic heart failure, wherein at least the steps of initiating operation, detecting, calculating and displaying the numerical value of the differential thoracic impedance of the person are repeated on at least a daily basis and further comprising the step of monitoring progress of the chronic heart failure of the user from the differential thoracic impedance values of the user.

4. The method of claim 1 wherein the user'"'"'s thoracic impedance is measured on at least a daily basis to monitor the thoracic fluid level of the user.

5. The method of claim 4, wherein the daily measurements are taken at substantially the same time during the day.

6. The method of claim 5, wherein the daily measurements are taken before the user eats a first meal of the day.

7. The method of claim 1 wherein the user'"'"'s thoracic fluid level is monitored;

and

each of the first, second, third and fourth electrodes is electrically coupled with an electrode pad and wherein the connecting step comprises the step of adhering the electrode array to the thorax of the user so as to operatively couple each of the first, second, third and fourth electrode pads to the user'"'"'s outer skin in line with the user'"'"'s sternum.

8. The method of monitoring thoracic fluid level of claim 7 wherein the first through the fourth electrodes are the only electrodes connected between the user and the base unit during the initiating operation step.

9. The method of monitoring thoracic fluid level of claim 8 further comprising between the initiating operation and the recording steps, the steps of determining a numerical value of thoracic impedance of the user and displaying the numerical value on the display.

10. A thoracic impedance monitor for determining thoracic impedance of a user, comprising:

an electrode array including a single linear electrode array lead and at least first, second, third, and fourth electrodes arranged axially along the single electrode array lead and connectable to the user at corresponding first, second, third, and fourth separate locations on a body of the user; and

a portable base unit operatively connected to the electrode array lead, including;

a power supply;

circuitry operatively connected to one of the first and second electrodes and to one of the third and fourth electrodes for generating an electrical signal for delivery to the one of the first and second electrodes and to the one of the third and fourth electrodes;

circuitry operatively connected to the other of the first and second electrodes and the other of the third and fourth electrodes for detecting differential electrical potential;

circuitry for calculating a numerical value of thoracic impedance of the user based upon the differential electrical potential; and

a display for displaying the numerical value of thoracic impedance of the user;

wherein the second electrode is operatively placed on the user'"'"'s body at the junction of the user'"'"'s clavicles, superior to the sternum and the third electrode is placed on the user'"'"'s body at the xiphoid-sternal junction;

wherein the first electrode is placed higher on the user'"'"'s body substantially along a centerline of the user'"'"'s sternum at a first predetermined distance from the second electrode and the fourth electrode is placed lower on the user'"'"'s body substantially along the centerline of the user'"'"'s sternum at a second pre-determined distance from the third electrode;

wherein the first and second electrodes are spaced on the electrode array lead at the first pre-determined distance and the third and fourth electrodes are spaced on the electrode array lead at the second pre-determined distance, such that with the electrode array lead fully extended, the first and second electrodes are spaced apart the first pre-determined distance and the third and fourth electrodes are spaced apart the second pre-determined distance;

wherein the first and second pre-determined distances are each about five cm (about two inches); and

wherein the circuitry for calculating thoracic impedance is configured to sample thoracic voltage through the second and third electrodes at predetermined intervals for a number of times, add the sampled thoracic voltages to generate a sum, divide the sum by the number of times to provide an averaged thoracic voltage value;

scale the averaged thoracic voltage value and combine the scaled averaged thoracic voltage value with a predetermined offset value to generate a numerical value of the differential thoracic impedance displayed on the display.

11. The thoracic impedance monitor of claim 10 wherein the numerical value of the differential thoracic impedance is the only numerical value the circuitry of the portable base unit is configured to display on the display.

12. The thoracic impedance monitor of claim 11 wherein the circuitry for detecting differential electrical potential consists essentially of a low pass filter, a differential amplifier and an analog to digital converter operably connected between the second and third electrodes and the circuitry for calculating thoracic impedance.

13. The thoracic impedance monitor of claim 10 wherein the first through fourth electrodes are the only electrodes provided to connect between the user'"'"'s body and the base unit to measure thoracic impedance.

14. The thoracic impedance monitor of claim 10, wherein the electrical signal is delivered to the first and fourth electrodes and the differential electrical potential is measured between the second and third electrodes.

15. The thoracic impedance monitor of claim 10, wherein the circuitry generating an electrical signal generates a current of about 2 mA and the circuitry detecting differential electrical potential detects a voltage in the range of about 20 mV to about 100 mV, corresponding to a thoracic impedance of the user in the range of about 10 to about 50 ohms.

16. The thoracic impedance monitor of claim 10, wherein the electrical signal is a pure sinusoidal wave generated by electrical components including a constant current source and a clock oscillator.

17. The thoracic impedance monitor of claim 16, wherein the electrical signal has a frequency in the range of about 90 kHz to about 110 kHz and current in the range of about 1.97 mA to about 1.99 mA.

18. The thoracic impedance monitor of claim 17, wherein the electrical signal has a frequency of about 100 kHz and a current of about 1.98 mA.

19. The thoracic impedance monitor of claim 10, wherein the base unit further including a handle to facilitate transport of the base unit.

20. The thoracic impedance monitor of claim 10, wherein the power supply is provided by batteries.

21. The thoracic impedance monitor of claim 10, the base unit further including a serial data port.

22. The thoracic impedance monitor of claim 10 wherein the electrode array includes at least first, second, third, and fourth electrodes arranged sequentially and axially along the linear electrode array lead;

wherein the first and second electrodes are spaced apart a first pre-determined distance by a first portion of the electrode lead and the third and fourth electrodes are spaced apart a second pre-determined distance by a second portion of the electrode lead equal to the first pre-determined distance; and

wherein the electrode lead is sufficiently flexible between the second and third electrodes to vary the distance between the second and third electrodes on the user'"'"'s body.

23. The thoracic impedance monitor of claim 22 wherein the first, second, third and fourth electrodes are arranged consecutively along the array and wherein the second and third electrodes of the array are spaced apart a distance along the array greater than the equal pre-determined first and second distances and sufficient to position one of the second and third electrodes on the thorax of any adult user at a junction of the adult user'"'"'s clavicles and the other of the second and third electrodes on the thorax of the adult user just beyond the adult user'"'"'s xiphoid-sternal junction away from the clavicles and further comprising adhesive located on the electrode array so as to adhere each of the first, second, third and fourth electrodes to skin of the user'"'"'s thorax.

24. The thoracic impedance monitor of claim 22 further comprising a first electrode pad assembly of the electrode array including a body member mounting first and second conductive electrode pads, the first and second conductive electrode pads being spaced apart from one another the first pre-determined distance on the body member and being exposed on one side of the body member for contact with the user'"'"'s body, each electrode pad being coupled with a separate one of the first and second electrodes.

25. The thoracic impedance monitor of claim 24 further comprising a second electrode pad assembly of the electrode array identical to the first electrode pad assembly and releasably coupled with the third and fourth electrodes.

26. The thoracic impedance monitor of claim 24 wherein the second and third electrodes of the electrode array are spaced apart from one another by a third portion of the electrode lead a distance sufficient to at least mount one of the second and third electrodes to any adult user'"'"'s thorax at the junction of adult user'"'"'s clavicles and the other of the second and third electrodes to the user'"'"'s thorax just beyond the user'"'"'s xiphoid-sternal junction away from the clavicles.

27. The thoracic impedance monitor of claim 10 wherein the electrode array further comprises:

electrode pads electrically coupled with each of the first, second, third and fourth electrodes; and

adhesive located to operatively couple each of the first, second, third and fourth electrode pads to the user'"'"'s outer skin in line with the user'"'"'s sternum.