Measuring hematocrit and estimating hemoglobin values with a non-invasive, optical blood monitoring system

• US 8,287,739 B2
• Filed: 02/03/2012
• Issued: 10/16/2012
• Est. Priority Date: 11/05/2008
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Barrett, Louis LeeGrande, Peterson, David Wayne, Sammann, Kristian Allen
• Primary Examiner(s): Kim, John
• Application Number:
  US13/366,119
• Publication Number:
  US 20120136582A1
• Time in Patent Office: 256 Days
• Field of Search: 210/645, 210/646, 210/739, 210/745, 210/85, 210/86, 210/97, 210/134, 210/143, 604/4.01, 604/5.01, 604/5.04, 604/6.07, 422/50, 422/68.1, 436/43, 436/70, 356/39, 356/40, 702/19, 600/301, 600/328, 600/485
• US Class Current: 210/739
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2205/3313 used specific wavelengths
• CPC Class Codes: A61M 2230/207 hematocrit
• CPC Class Codes: Y10T 436/11 Automated chemical analysis

Abstract

An optical blood monitoring system with a ratiometric model determines hematocrit values for a hemodialysis patient, from which hemoglobin values for the patient are estimated. The ratiometric model is calibrated, normally against a cell counter, using blood from a blood bank. The blood from a blood bank is preserved in a long term preservative which is typically different than that found in clinical settings. The hematocrit value determined by the ratiometric model is scaled by scaling factor so that the estimated hemoglobin level output from the monitor consistently matches that measured in a clinical setting. The hematocrit scaling factor is substantially about 1.033 when the patient'"'"'s blood sample is stored in a short term preservative ethylene diamine tetra acetic, and is substantially about 1.06 when the hematocrit is measured in the blood sample without preservative being added to the blood sample. The hemoglobin value can also be adjusted for altitude.

Claims

1. A method for calibrating and subsequently operating a device during a dialysis session for determining hematocrit values, the method comprising:

calibrating the device by (a) measuring the hematocrit value of whole blood from a supply of blood containing an anticoagulant using an in vitro method, (b) baselining the measured hematocrit value taken from the supply of blood against an independently determined value of the hematocrit and (c) determining a scaling factor to account for an effect of the anticoagulant on an accuracy of the measured hematocrit values; and

operating the device during the dialysis session by (d) measuring in a non-invasive manner the hematocrit values of a patient'"'"'s blood which does not contain the anticoagulant, (e) scaling the measured hematocrit values in keeping with the scaling factors to account for an absence of the anticoagulant in the patient'"'"'s blood; and

(f) displaying the scaled measured values.

2. The method of claim 1 wherein the anticoagulant is a first anticoagulant and the method further comprises:

measuring the hematocrit value of the patient'"'"'s blood containing a second anticoagulant using an in vitro method; and

while determining the scaling factor, taking into account that the hematocrit measured in the non-invasive manner during the dialysis session does not include the second anticoagulant so that the displayed values are in keeping with the values of hematocrit measured from the patient'"'"'s blood using the in vitro method and containing the second anticoagulant.

3. The method of claim 1 including estimating hemoglobin values from the scaled measured values of hematocrit.

4. The method of claim 3 including adjusting the estimated hemoglobin values to compensate for altitude.

5. The method of claim 1 including diluting the supply of blood to provide samples of different hematocrit values and calibrating the device using each sample.

6. The method of claim 1 wherein the patient'"'"'s blood contains heparin, which is not accounted for by the scaling factor.

7. The method of claim 1 wherein the scaling factor is a linear slope adjustment.

8. The method of claim 2 wherein the in vitro method for measuring the hematocrit value of the patient'"'"'s blood containing the second anticoagulant includes drawing blood from the patient in a clinical setting.

9. The method of claim 1 wherein the supply of blood is a saline diluted sample of hemo-concentrated blood from a blood bank.

10. The method of claim 1 wherein the independently determined value of the hematocrit is determined by a cell counter.

11. The method of claim 1 wherein the first anticoagulant is citrate phosphate dextrose (CPD).

12. The method of claim 2 wherein the second anticoagulant is potassium ethylene diamine tetra acetic (K3EDTA).

13. A blood monitor for use in a hemodialysis system, the blood monitor comprising:

a sensor assembly for collecting information from a patient'"'"'s blood in flowing through the hemodialysis system;

a controller including a ratiometric model for calculating a hematocrit value from the information collected from the sensor assembly, wherein the ratiometric model is calibrated using a supply of blood containing a first anticoagulant using an in vitro method, and

a display for displaying hematocrit values measured from a patient'"'"'s blood during a dialysis session, where the display scales the values to account for an absence of the first or a second anticoagulant in the patient'"'"'s blood in the hemodialysis system.

14. The blood monitor of claim 13 wherein the blood containing the first anticoagulant is blood bank blood.

15. The blood monitor of claim 13 wherein the second anticoagulant is a anticoagulant in blood drawn from the patient for laboratory testing.

16. The blood monitor of claim 13 wherein the controller includes means for estimating a value of hemoglobin in the patient'"'"'s blood.

17. The blood monitor of claim 16 including a memory containing information describing an altitude of an environment for the monitor for correcting the estimated value of the hemoglobin in the patient'"'"'s blood.