Adaptive calibration for pulse oximetry

• US 6,839,580 B2
• Filed: 12/04/2002
• Issued: 01/04/2005
• Est. Priority Date: 12/06/2001
• Status: Expired due to Term

• Current Assignee: Philips RS North America LLC (Koninklijke Philips N.V.)
• Original Assignee: RIC INVESTMENTS LLC (Respironics Incorporated)
• Inventors: Shankar, Uday S., Iyer, Vijay K., Zonios, George
• Primary Examiner(s): Jones, Mary Beth
• Assistant Examiner(s): KREMER, MATTHEW J
• Application Number:
  US10/309,878
• Publication Number:
  US 20030114738A1
• Time in Patent Office: 762 Days
• Field of Search: 600322-323, 600330-331, 600309-310, 356 39- 42, 357 39- 42
• US Class Current: 600/323
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes

Abstract

A method for calibrating a pulse oximeter device and an apparatus incorporating the method and a system for utilizing the method. The method is based on modeling light propagation in tissue at two wavelengths, typically, one in the red and one in the infrared range of the spectrum. A formula is derived relating the arterial oxygen saturation to a ratio R commonly measured by standard pulse oximeters. A specific parameter is identified and utilized in the calibration of the oximeter. This parameter is formulated in terms of the DC signals measured by the pulse oximeter at the two wavelengths. An empirical method for estimating this parameter based on experimental data is also described.

Claims

1. A method of calibrating a pulse oximeter comprising:

selecting a probe having an emitter, a detector, and a pathlength between the emitter and detector;

measuring transmission of light through a tissue of interest with the probe;

compiling a database of measured values characterizing the transmission of light through such a tissue;

formulating a value for a parameter k_DC as a function of at least one of the measured values, wherein k_DC is determined based only on empirical data; and

incorporating the parameter k_DC into a calibration equation for determining a value for SpO₂, wherein the calibration equation includes using k_DC as a multiplier for a value determined from the measured values.

2. The method of claim 1, wherein the tissue of interest is a living being.

3. The method of claim 2, wherein the steps of measuring, compiling, formulating, and incorporating are repeated for the living being over a range of SaO₂ levels.

4. The method of claim 3, wherein the range of SaO₂ levels is greater than 70%.

5. The method of claim 3, wherein the range of SaO₂ levels is between about 15% and about 65%.

6. The method of claim 1, wherein the probe is an invasive probe.

7. The method of claim 1, wherein the probe'"'"'s pathlength is approximately 1 mm to about 5 mm.

8. The method of claim 1, wherein, in the formulating step, the measured value includes a DC value.

9. The method of claim 1, wherein, in the compiling step, the measured values includes an AC and a DC component.

10. The method of claim 1, wherein, before the incorporating step, the measured values are used to calculate a Ratio R as the value for which k_DC is used as the multiplier.

11. A method of performing optical blood oximetry comprising:

measuring the transmission of light through tissue;

determining at least one DC value based upon the transmission of light measurements;

selecting a calibration parameter k_DC based upon the determined DC value, wherein the calibration parameter is determined based only on empirical data; and

estimating SaO₂ based upon the selected calibration parameter by using the calibration parameter as a multiplier for a value determined from the measuring step.

12. The method of claim 11, further comprising the step of providing updated oxygen saturation estimates adapted to changes in the measured transmission.

13. The method of claim 11, further comprising providing a pulse oximeter probe that includes a light source capable of emitting light at two or more wavelengths, a detector, and a measurable distance between the light source and the detector.

14. The method of claim 11, wherein the step of determining further includes:

quantifying an AC value based upon the transmission of light;

calculating a Ratio R; and

relating R to the calibration parameter that accounts for background absorption and scattering of light.

15. The method of claim 11, wherein the estimating step comprises:

quantifying the k_DC value; and

selecting a corresponding SaO₂ based upon previously determined clinical data.

16. A method of performing optical blood oximetry comprising:

measuring the transmission of light through tissue;

determining at least one DC value based upon the transmission of light measurements;

selecting a calibration parameter k_DC based upon the determined DC value, wherein k_DC includes a partial derivative D_r value; and

estimating SaO₂ based upon the selected calibration parameter.

17. A method of performing optical blood oximetry comprising:

(a) measuring the transmission of light through tissue;

(b) determining at least one DC value based upon the transmission of light measurements by performing the steps including;

(1) quantifying an AC value based upon the transmission of light,

(2) calculating a Ratio R, and

(3) relating R to the calibration parameter that accounts for background absorption and scattering of light including determining a partial derivative D_r value, and using the D_r value to relate R to the calibration parameter;

(c) selecting a calibration parameter k_DC based upon the determined DC value; and

(d) estimating SaO₂ based upon the selected calibration parameter.

18. A method of performing optical blood oximetry comprising:

(a) measuring the transmission of light through tissue;

(b) determining at least one DC value based upon the transmission of light measurements by performing the steps including;

(1) quantifying an AC value based upon the transmission of light, including estimating a partial derivative D_r value,

(2) calculating a Ratio R, and

(3) relating R to the calibration parameter that accounts for background absorption and scattering of light;

(c) selecting a calibration parameter based upon the determined DC value; and

(d) estimating SaO₂ based upon the selected calibration parameter.

19. A physiological condition measuring device comprising:

light generating means;

light detecting means, wherein an optical path having pathlength is defined between the light generating means and the light detecting means; and

a processing system that measures light incident upon the light detecting means and returns a solution determined from a calculation that includes multiplying (1) a value determined from the measured light and (2) a calibration parameter k_DC that is based only on empirical data.

20. A measuring device according to claim 19, wherein the physiological condition is oxygen saturation.

21. The apparatus of claim 20, further comprising means for adaptively calibrating the predicted arterial oxygen saturation in response to the signals received from the probe.

22. A measuring device of claim 19, wherein the processing system produces a measurement of SpO₂.

23. A measuring device according to claim 19, wherein the optical pathlength is less than about 1 cm.

24. A measuring device according to claim 19, wherein the processing system is calibrated to measure SaO₂ in a range of about 10% to about 70%.

25. An apparatus for determining oxygen saturation of hemoglobin in arterial blood using signals received from a probe, the signals being indicative of the light absorption of arterial blood, which has pulsatile and non-pulsatile components, at two or more light wavelengths, the apparatus comprising:

means responsive to the signals received from the probe;

means for convening the signals received into data;

memory means for storing the data;

computing means for calculating parameters from the data; and

means for relating the calculated parameters to a predicted arterial oxygen saturation, that includes (1) selecting a calibration parameter k_DC based upon the non-pulsatile components, wherein the calibration parameter is determined based only on empirical data, and (2) estimating oxygen saturation based upon (a) the selected calibration parameter and (b) the calculated parameters, wherein estimating the oxygen saturation includes using the calibration parameter as a multiplier for the calculated parameters.

26. A system for performing pulse oximetry comprising:

a probe including at least one light source for transmitting light and at least one detector for detecting the transmitted light;

a processing system in communication with the probe so as to receive signals from the probe, wherein the processing system (a) determines data corresponding to

     1) first variables indicative of the optical parameters of a tissue being probed based on the received signals and

     2) second variables related to a parameter k_DC that is determined based only on empirical data and that accounts for the scattering and absorption of light by the tissue, and (b) determines an estimate of oxygen saturation by performing a calculation that includes multiplying the first variables by the second variables.