Measurement of cardiac output and blood volume by non-invasive detection of indicator dilution for hemodialysis

• US 8,337,444 B2
• Filed: 05/03/2007
• Issued: 12/25/2012
• Est. Priority Date: 05/22/2001
• Status: Active Grant

• Current Assignee: The Alfred E. Mann Institute For Biomedical Engineering At The University Of Southern California (University of Southern California)
• Original Assignee: The Alfred E. Mann Institute For Biomedical Engineering At The University Of Southern California (University of Southern California)
• Inventors: Rubinstein, Eduardo H., Holschneider, Daniel P., Maarek, Jean-Michel I.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US11/744,157
• Publication Number:
  US 20080015434A1
• Time in Patent Office: 2,063 Days
• Field of Search: 600 401- 616, 600 65- 67, 600/317, 600/322, 600/431, 600/526, 356/442, 128633-635, 128664-667, 422 44- 48, 604 401- 616, 604 65- 67
• US Class Current: 604/6.08
• CPC Class Codes: A61B 2503/40 Animals
• CPC Class Codes: A61B 5/0275 using tracers, e.g. dye dilution
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation

Abstract

A system and method of non-invasive or minimally invasive evaluating the cardiovascular system parameters to estimate the cardiac output and circulating blood volume of a patient undergoing hemodialysis. Intravascular indicators are stimulated, and emissions patterns detected for computation of cardiac output, cardiac index, blood volume and other indicators of cardiovascular health before and during hemodialysis.

Claims

1. A system for determining non-invasively at least one cardiovascular parameter of a patient undergoing hemodialysis comprising:

a) a dialyzer configured to perform hemodialysis on the patient, wherein the hemodialysis comprises blood removal from and administration of a fluorescent dye to the cardiovascular system of the patient;

b) a probe assembly comprising;

i) an optical illumination source configured to illuminate the removed blood having the administered fluorescent dye with a first wavelength of light, wherein the illumination causes the fluorescent dye to emit light of a second wavelength, wherein the second wavelength is different than the first wavelength; and

ii) at least one optical detector configured to detect the intensity of light, having the second wavelength, that is emitted from the illuminated fluorescent dye, and configured to send a corresponding electronic signal;

c) a processor configured to receive the sent electronic signal and to estimate at least one cardiovascular parameter of the patient based on the sent electronic signal;

wherein the processor is configured to correct the estimation of the at least one cardiovascular parameter for changes in the blood hematocrit or hemoglobin content of the patient undergoing hemodialysis; and

d) a monitoring system configured to monitor the estimated cardiovascular parameter during hemodialysis.

2. The system of claim 1, wherein the administered fluorescent dye is indocyanine green (ICG).

3. The system of claim 2, wherein the probe further comprises a plurality of optical detectors that are configured to detect plurality of light intensities having the same or different wavelengths.

4. The system of claim 3, wherein the processor is further configured to determine the ICG concentration.

5. The system of claim 3, wherein the processor is configured to determine the ICG concentration based on combined relationships:

C_ICG=A·

T^α

·

B_Fluo and C_ICG=K·

R^γ

·

B_Fluo

where C_ICG is the blood ICG concentration, B_Fluo represents the back-fluorescence intensity having the second wavelength, T and R being the transmitted and reflected lights, respectively, having the first wavelength and parameters A, K, α and

γ

are predetermined constants.

6. The system of claim 4, wherein the processor is configured to determine the ICG concentration based on a relationship:

C_ICG=A·

T^α

·

B_Fluo

where C_ICG is the blood ICG concentration, B_Fluo represents the back-fluorescence intensity having the second wavelength, T is the transmitted light intensity having the first wavelength, and parameters A and α

are predetermined constants.

7. The system of claim 4, wherein the processor is configured to determine the ICG concentration based on a relationship:

C_ICG=B·

T^β

·

F_Fluo

where C_ICG is the blood ICG concentration, F_Fluo represents the forward-fluorescence intensity having the second wavelength, T is the transmitted light intensity having the first wavelength and parameters B and β

are predetermined constants.

8. The system of claim 4, wherein the processor is configured to perform a computation using the following relationship to determine the ICG concentration:

C_ICG=K·

R^γ

·

B_Fluo

where C_ICG is the blood ICG concentration, B_Fluo is the back-fluorescence intensity having the second wavelength, R is the reflected light intensity having the first wavelength and the exponent γ and

parameter K being predetermined constants.

9. The system of claim 4, wherein the processor is configured to determine the ICG concentration based on a relationship:

C_ICG=K·

R^γ

·

F^Fluo

where C_ICG is the blood ICG concentration, F_Fluo represents the forward-fluorescence intensity having the second wavelength, R is the reflected light intensity having the first wavelength, and parameters K and γ

are predetermined constants.

10. The system of claim 4, wherein the processor is configured to determine the ICG concentration based on combined relationships:

C_ICG=B·

T^β

·

F_Fluo and C_ICG=K·

R^γ

·

F_Fluo

where C_ICG is the blood ICG concentration, F_Fluo represents the forward-fluorescence intensity having the second wavelength, T and R are the transmitted and the reflected light intensities having a wavelength different than the second wavelength and the parameters B, K, β and

γ

are predetermined constants.

11. The system of claim 1, wherein the fluorescent dye is administered through inserting a fine catheter at any of peripheral vein, the arterio-venous (AV) fistula or the arterio-venous (AV) shunt.

12. The system of claim 1, wherein the dialyzer further comprises a transparent tubing configured to remove blood from the patient to the dialyzer, and wherein the probe is configured to be attached to the external wall of the tubing.

13. The system of claim 1, wherein the probe further comprises a second optical detector configured to detect a light intensity having the first wavelength.

14. The system of claim 13, wherein the second optical detector is configured to detect one of the reflected or transmitted light that is emitted from the removed blood.

15. The system of claim 1, wherein the optical detector is configured to detect one of the back-fluorescence or forward-fluorescence that is emitted by the fluorescent dye.

16. The system of claim 1, wherein the probe is pre-calibrated.

17. The system of claim 1, wherein the probe is calibrated non-invasively and in-vitro.

18. The system of claim 1, wherein the dialyzer further comprises a side port configured to return the dialyzed blood to the patient, and wherein the fluorescent dye is administered through the side port into the cardiovascular system of the patient.

19. The system of claim 1, wherein the at least one cardiovascular parameter is cardiac output and circulating blood volume.

20. The system of claim 1, wherein the cardiovascular parameter is cardiac output.

21. The system of claim 20, wherein the processor is further configured to estimate the cardiac output through a dilution curve.

22. The system of claim 1, wherein the cardiovascular parameter is circulating blood volume.

23. The system of claim 22, wherein the processor is further configured to estimate the circulating blood volume through subtracting the removed blood volume in the dialyzer'"'"'s compartment from the total circulating blood volume of the patient.

24. The system of claim 1, wherein the monitoring system is further configured to adjust the rate of the blood removal from the patient when the estimated cardiac output and/or the circulating blood volume changes.