Device and method for monitoring and controlling physiologic parameters of a dialysis patient using segmental bioimpedence

• US 6,615,077 B1
• Filed: 08/14/2000
• Issued: 09/02/2003
• Est. Priority Date: 08/14/2000
• Status: Expired due to Term

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Renal Research Institute LLC (Fresenius SE & Co. KGaA)
• Inventors: Levin, Nathan W., Zhu, Fansan
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US09/638,657
• Time in Patent Office: 1,114 Days
• Field of Search: 600/547, 600/483, 600/322, 600/300, 600/310, 600/323, 600/324, 600/325, 600/326, 600/327, 600/485, 600/529, 600/490, 600/500, 600/504-506, 600/531-538, 604/66, 604/67, 210/646, 210/647
• US Class Current: 600/547
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• 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: A61M 1/16 with membranes
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir
• CPC Class Codes: A61M 2205/50 with microprocessors or computers

Abstract

The present invention includes a method of determining the dry body weight of a patient undergoing dialysis by means of segmental bioimpedance analysis. In preferred embodiments, dry body weight is determined by comparison to the bioimpedance values of normal subjects or by monitoring changes in bioimpedance during dialysis. One embodiment of the present invention is a device for determining dry body weight during dialysis.

Claims

1. A method for determining the hydration status of a dialysis patient comprising the steps of:

measuring the resistivity of a body segment of the patient;

correlating the measured resistivity with predetermined normal dry weight values; and

deriving the patient'"'"'s hydration status.

2. The method of claim 1, wherein the resistivity of the interstitial fluid in the body segment is measured.

3. The method of claim 1, wherein the resistivity of the body segment is determined while applying a pressure of at least about systolic blood pressure.

4. The method of claim 3, wherein the pressure is applied from about 120 mmHg to about 240 mmHg.

5. The method of claim 1, wherein the body segment is a limb segment.

6. The method of claim 1, wherein the body segment is a thigh segment.

7. A method for determining a hemodialysis patient'"'"'s dry weight comprising the steps of:

periodically measuring the resistivity of a body segment during hemodialysis;

comparing successive resistivity measurements; and

identifying the patient'"'"'s dry weight when a substantially constant resistivity is reached.

8. The method of claim 7, wherein the resistivity of the body segment is measured from about every 5 minutes to about every 20 minutes during hemodialysis.

9. The method of claim 8, wherein the resistivity of the body segment is measured about every 10 minutes during hemodialysis.

10. The method of claim 7, wherein the resistivity of the body segment is measured at a pressure of at least about systolic blood pressure.

11. The method of claim 10, wherein the pressure is from about 120 mmHg to about 240 mmHg.

12. A method for dialysing a patient to the patient'"'"'s dry weight comprising the steps of:

measuring the resistivity of a body segment of the patient;

correlating the measured resistivity with predetermined normal dry weight values;

deriving the patient'"'"'s hydration; and

continuing hemodialysis until the resistivity of the body segment correlates with the predetermined normal dry weight values.

13. The method of claim 12, wherein the resistivity of the body segment is measured at a pressure of at least about systolic blood pressure.

14. A method for hemodialysing a patient to the patient'"'"'s dry weight comprising the steps of:

periodically measuring the resistivity of a body segment during hemodialysis;

comparing successive resistivity measurements; and

discontinuing hemodialysis when a substantially constant resistivity is reflected.

15. The method of claim 14, wherein the resistivity of the body segment is measured at a pressure of at least about systolic blood pressure.

16. The method of claim 14, wherein the resistivity of the body segment is measured from about every 5 minutes to about every 20 minutes during hemodialysis.

17. A method of monitoring the heart rate of a hemodialysis patient comprising the steps of:

determining a time interval between two successive bioimpedance wave peaks; and

multiplying the reciprocal of the time interval by 60 to obtain the heart rate.

18. A method of calculating the cardiac output of a patient in need thereof comprising the steps of:

measuring the stroke volume in an arm segment by bioimpedance analysis;

substantially simultaneously measuring the stroke volume in an ipsalateral leg

segment by bioimpedance analysis;

summing the stroke volume in the arm segment and the stroke volume in the leg segment; and

multiplying the sum by twice the heart rate to obtain the cardiac output.

19. The method of claim 18, wherein stroke volume of the arm segment is calculated by applying an external maximum pressure to the arm segment and determining the change in blood volume in the arm segment between the point of maximum pressure and the point at which no external pressure is applied divided by the number of heart beats between the two points in time, and wherein the stroke volume of the leg is calculated by applying an external maximum pressure to the leg segment and determining the change in blood volume in the leg segment between the point of maximum pressure and the point at which no external pressure is applied divided by the number of heart beats between two points in time.

20. A device for controlling a hemodialysis machine comprising:

a bioimpedance analysis measurement unit in electrical communication with a hemodialysis machine;

an electrical output means being in electrical communication with the bioimpedance analysis measurement unit and being attachable to a body segment, the electrical output means being adapted to apply electrical current to the body segment;

an electrical input means being in electrical communication with the bioimpedance analysis measurement unit and being attachable to a body segment, the electrical input means being adapted to receive the current transmitted through the body segment and transmit the same to the bioimpedance analysis measurement unit; and

wherein the bioimpedance analysis measurement unit is adapted to determine body segment resistivity based on the current transmitted through the body segment and wherein the bioimpedance analysis measurement unit provides feedback to the hemodialysis machine in response to the body segment resistivity.

21. The device of claim 20 further including means for applying pressure to the body segment, the pressure applying means being in electrical communication with the bioimpedance analysis measurement unit.

22. The device of claim 21 wherein the pressure applying means includes a pressure cuff, the pressure cuff being adapted to encircle the body segment.

23. The device of claim 22 wherein the electrical output means includes at least two injector electrodes, the electrical input means includes at least two measurement electrodes, and wherein the injector electrodes and the measurement electrodes are secured to the pressure cuff.

24. The device of claim 23 wherein the pressure cuff further includes at least one conductive band with opposing ends and at least one conductive plate positioned adjacent one of the ends of the conductive band, the conductive band extends substantially the length of the pressure cuff, the conductive plate is arranged to electrically contact the conductive band at a point along the length of the same wherein the distance between the conductive plate and the point of contact of the conductive band is substantially equal to the circumference of the body segment, and wherein the bioimpedance measurement unit is adapted to electrically determine body segment circumference based on the distance between the end of the band adjacent to the plate and the point of contact of the plate along the length of the band.

25. A device for monitoring hydration status in a hemodialysis patient comprising:

a bioimpedance analysis measurement unit;

an electrical output means being in electrical communication with the bioimpedance analysis measurement unit and being attachable to a body segment, the electrical output means being adapted to apply electrical current to the body segment;

an electrical input means being in electrical communication with the bioimpedance analysis measurement unit and being attachable to a body segment, the electrical input means being adapted to receive the current transmitted through the body segment and transmit the same to the bioimpedance analysis measurement unit; and

a microprocessor system in electrical communication with the bioimpedance analysis measurement unit;

wherein the bioimpedance analysis measurement unit is adapted to determine a body segment resistance based on the current transmitted through the body segment and to transmit the body segment resistance to the microprocessor system, and wherein the microprocessor system is adapted to calculate a body segment resistivity, correlate the body segment resistivity with predetermined normal dry weight values, and to derive the hydration status of the hemodialysis patient.

26. The device of claim 25 further including means for applying pressure to the body segment, the pressure applying means being in electrical communication with the bioimpedance analysis measurement unit.

27. The device of claim 26 wherein the pressure applying means includes a pressure cuff, the pressure cuff being adapted to encircle the body segment.

28. A device for monitoring hydration status in a hemodialysis patient comprising:

a bioimpedance analysis measurement unit;

an electrical output means being in electrical communication with the bioimpedance analysis measurement unit and being attachable to a body segment, the electrical output means being adapted to apply electrical current to the body segment, wherein the electrical output means includes at least two injector electrodes;

an electrical input means being in electrical communication with the bioimpedance analysis measurement unit and being attachable to a body segment, the electrical input means being adapted to receive the current transmitted through the body segment and transmit the same to the bioimpedance analysis measurement unit, wherein the electrical input means includes at least two measurement electrodes; and

a means for applying pressure to the body segment, the pressure applying means being in electrical communication with the bioimpedance analysis measurement unit, wherein the pressure applying means includes a pressure cuff, the pressure cuff being adapted to encircle the body segment;

wherein the bioimpedance analysis measurement unit is adapted to determine a body segment resistivity based on the current transmitted through the body segment, and wherein the injector electrodes and the measurement electrodes are secured to the pressure cuff.

29. The device of claim 28 wherein the pressure cuff further includes at least one conductive band with opposing ends and a conductive plate positioned adjacent one of the ends of the conductive band, the conductive band extends substantially the length of the pressure cuff, the conductive plate is arranged to electrically contact the conductive band at a point along the length of the same wherein the distance between the conductive plate and the point of contact of the conductive band is substantially equal to the circumference of the body segment, and wherein the bioimpedance measurement unit is adapted to electrically determine body segment circumference based on the distance between the end of the band adjacent to the plate and the point of contact of the plate along the length of the band.

30. A hemodialysis machine including a device for monitoring hydration status in a hemodialysis patient, the device comprising:

a bioimpedance analysis measurement unit;

an electrical output means being in electrical communication with the bioimpedance analysis measurement unit and being attachable to a body segment, the electrical output means being adapted to apply electrical current to the body segment; and

an electrical input means being in electrical communication with the bioimpedance analysis measurement unit and being attachable to a body segment, the electrical input means being adapted to receive the current transmitted through the body segment and transmit the same to the bioimpedance analysis measurement unit;

wherein the bioimpedance analysis measurement unit is adapted to determine body segment resistivity based on the current transmitted through the body segment.

31. A device for calculating cardiac output through bioimpedance measurements of a patient comprising:

a bioimpedance measurement unit;

a first electrical output means being in electrical communication with the bioimpedance analysis measurement unit and being attachable to an arm segment, the first electrical output means being adapted to apply electrical current to the arm segment;

a second electrical output means being in electrical communication with the bioimpedance analysis measurement unit and being attachable to a leg segment, the second electrical output means being adapted to apply electrical current to the leg segment;

a first electrical input means being in electrical communication with the bioimpedance analysis measurement unit and being attachable to an arm segment, the electrical input means being adapted to receive the current transmitted through the arm segment and transmit the same to the bioimpedance analysis measurement unit;

a second electrical input means being in electrical communication with the bioimpedance analysis measurement unit and being attachable to a leg segment, the electrical input means being adapted to receive the current transmitted through the leg segment and transmit the same to the bioimpedance analysis measurement unit;

a first pressure applying means for applying a maximum pressure to the arm segment, the first pressure applying means being in electrical communication with the bioimpedance analysis measurement unit;

a second pressure applying means for applying a maximum pressure to the arm segment, the second pressure applying means being in electrical communication with the bioimpedance analysis measurement unit; and

a means for selectively electronically connecting the bioimpedance analysis measurement unit between the first electrical input and output means and the second electrical input and output means;

wherein the bioimpedance analysis measurement unit is adapted to selectively measure stroke volume in the arm and leg segments by bioimpedance analysis.