Method and apparatus for noninvasively determining hematocrit

• US 5,526,808 A
• Filed: 04/20/1995
• Issued: 06/18/1996
• Est. Priority Date: 10/04/1990
• Status: Expired due to Term

• Current Assignee: Microcor, Inc.
• Original Assignee: Microcor, Inc.
• Inventors: Kaminsky, Allan L.
• Primary Examiner(s): Hayes, Gail O.
• Assistant Examiner(s): Poinvil, Frantzy
• Application Number:
  US08/425,404
• Time in Patent Office: 425 Days
• Field of Search: 364/709, 364/710, 128/632, 128/633, 128/637, 128/691, 128/693, 128/734
• US Class Current: 600/370
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/4869 Determining body composition
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

A method and apparatus for noninvasively determining hematocrit utilizing the frequency dependent electrical impedance characteristics of whole blood by electrically stimulating a patient body portion containing a pulsatile vascular compartment with a constant current source at two selected frequencies, one of which is high enough that the capacitive nature of erythrocytes will significantly affect the magnitude of the impedance of the blood. Sensed voltage across the stimulated body portion at the two frequencies is representative of the corresponding magnitudes, and the method further includes detecting the signal envelopes of the sensed voltages, isolating and converting the pulsatile components of the signal envelopes to the digital domain, normalizing each isolated converted pulsatile component against the voltage baseline of its carrier waveform and creating a ratio of the normalized isolated pulsatile components representative of the patient'"'"'s hematocrit. The ratio is indexed to a look-up table constructed from clinical studies correlating such ratios at the two selected frequencies to hematocrit, and the hematocrit corresponding to the created ratio is displayed. A plurality of ratios of sets of time-matched pulsatile component segments are created and averaged using a weighted averaging technique which more heavily weights ratios created from more significant segment sets, the weighted ratio average being correlated to hematocrit via the look-up table.

Claims

1. An apparatus for noninvasive determination of the relative volume percent of erythrocytes, also termed the hematocrit, of whole blood having an impedance, comprising:

means for producing a constant current at first low and second high carrier wave frequencies, said first low frequency being below a frequency zone within which said erythrocytes significantly affect the magnitude of the impedance of said whole blood, and said second high frequency being within said frequency zone;

means for stimulating a patient body portion including a pulsatile vascular compartment containing said whole blood with said first low and second high frequency current;

means for sensing voltage at each of said first low and second high carrier wave frequencies across said stimulated patient body portion;

means for detecting a signal envelope of each of said sensed voltages, each of said detected signal envelopes having a pulsatile component and a baseline component;

means for isolating the pulsatile component of each of said detected signal envelopes;

processing means for extracting at least one set of time-matched segments of said isolated pulsatile signal envelope components, creating a ratio from said isolated time-matched pulsatile signal envelope component segments of said at least one set, and for correlating said ratio to said hematocrit.

2. The apparatus of claim 1, wherein said processing means includes means for normalizing said isolated pulsatile signal envelope component segments before creating said ratio.

3. The apparatus of claim 1, further including means for digitizing at least a portion of said isolated pulsatile signal components of said detected signal envelopes prior to said creation of said ratio.

4. The apparatus of claim 3, further including means for eliminating said baseline components of said detected signal envelopes prior to the digitizing thereof by said digitizing means.

5. The apparatus of claim 4, further including means for magnification of said isolated pulsatile signal envelope components after said elimination of said baseline components.

6. The apparatus of claim 1, further including means for digitizing said detected signal envelopes in their entirety for isolation of said pulsatile components therefrom.

7. The apparatus of claim 3, wherein said digitizing means comprises an analog to digital converter.

8. The apparatus of claim 7, wherein said analog to digital converter includes means for altering a range of said isolated signal components responsive to commands from said processor means.

9. The apparatus of claim 8, wherein said analog to digital converter includes multiplexor means for selecting analog signals for conversion to the digital domain from said detector means and from said range alteration means.

10. The apparatus of claim 9, wherein said multiplexor means includes means for selecting said analog signals for digitizing responsive to commands from said processor means.

11. The apparatus of claim 1, wherein said processing means further includes means for extracting a plurality of time-matched pulsatile signal component segments at said first low and second high frequencies at intervals over a period of time, to create a plurality of said ratios therefrom, to average said plurality of ratios and to correlate said averaged ratios to said hematocrit.

12. The apparatus of claim 11, wherein said processing means, in performing said averaging, includes means for weighting significant ratios more heavily.

13. The apparatus of claim 1, wherein said detecting means comprises a first and a second AM detector, one for each of said first low and second high carrier wave frequencies.

14. The apparatus of claim 1, wherein said correlating means comprises look-up table means for correlating ratio values to hematocrit, and said created ratio is employed by said processor means as an index to said look-up table means to determine the hematocrit corresponding thereto.

15. The apparatus of claim 1, further including means for displaying the hematocrit corresponding to said created ratio.

16. A method of noninvasively determining the relative volume percent of erythrocytes, also termed the hematocrit, of whole blood having an impedance, comprising:

producing a constant current at first low and second high carrier wave frequencies, said first low frequency being below a frequency zone within which said erythrocytes significantly affect the magnitude of the impedance of said whole blood, and said second high frequency being within said frequency zone;

stimulating a patient body portion including a pulsatile vascular compartment containing said whole blood with said first low and second high frequency current;

sensing voltage at each of said first low and second high carrier wave frequencies across said stimulated patient body portion;

detecting a signal envelope of each of said sensed voltages, each of said detected signal envelopes having a pulsatile component and a baseline component;

isolating the pulsatile component of each of said detected signal envelopes; and

extracting at least one set of time-matched segments of said isolated pulsatile signal envelope components, creating a ratio from said isolated time-matched pulsatile signal envelope component segments of said at least one set, and correlating said ratio to said hematocrit.

17. The method of claim 16, further including the step of normalizing said isolated pulsatile signal envelope component segments before creating said ratio.

18. The method of claim 16, further including the step of digitizing at least a portion of said isolated pulsatile signal components of said detected signal envelopes prior to said creation of said ratio.

19. The method of claim 16, further including the step of eliminating said baseline components of said detected signal envelopes prior to the step of digitizing.

20. The method of claim 19, further including the step of magnifying said isolated pulsatile signal envelope components after said elimination of said baseline components.

21. The method of claim 18, further comprising digitizing said detected signal envelopes in their entirety for isolation of said pulsatile components therefrom.

22. The method of claim 16, comprising extracting a plurality of time-matched pulsatile signal component segments at said first low and second high frequencies at intervals over a period of time, creating a plurality of ratios therefrom, averaging said plurality of ratios and correlating said averaged ratios to said hematocrit.

23. The method of claim 22, wherein significant ratios are weighted more heavily in said averaging thereof.

24. The method of claim 16, wherein said step of correlating further comprises:

providing a look-up table correlating ratio values to hematocrit; and

using said created ratio as an index to said look-up table to determine the hematocrit corresponding thereto.

25. The method of claim 16, further including the step of displaying the hematocrit corresponding to said created ratio.

26. An apparatus for determination of the relative volume percent of erythrocytes, also termed the hematocrit, of whole blood having an impedance, comprising:

means for producing a constant current at first low and second high carrier wave frequencies, said first low frequency being below a frequency zone within which said erythrocytes significantly affect the magnitude of the impedance of said whole blood, and said second high frequency being within said frequency zone;

means for applying said first low and second high frequency current to a volume of whole blood;

means for sensing voltage at each of said first and second carrier wave frequencies across said volume; and

processing means for creating a ratio from said sensed voltages, and for correlating said ratio to said hematocrit.

27. The apparatus of claim 26, wherein said volume of said whole blood is flowing and said processing means includes means for extracting a plurality of time-matched segments of said sensed voltages over a period of time, to create a plurality of said ratios therefrom, to average said plurality of ratios and to correlate said averaged ratios to said hematocrit.

28. The apparatus of claim 27, wherein said processing means, in performing said averaging, includes means for weighting significant ratios more heavily.

29. The apparatus of claim 26, wherein said correlating means comprises look-up table means for correlating ratio values to hematocrit, and said created ratio is employed by said processor means as an index to said look-up table means to determine the hematocrit corresponding thereto.

30. The apparatus of claim 26, further including means for displaying the hematocrit corresponding to said created ratio.