Method for spectrophotometric blood oxygenation monitoring

• US 8,078,250 B2
• Filed: 03/16/2006
• Issued: 12/13/2011
• Est. Priority Date: 07/26/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cas Medical Systems Incorporated (Edwards Lifesciences Corporation)
• Inventors: Chen, Bo, Benni, Paul B.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US11/376,894
• Publication Number:
  US 20060189861A1
• Time in Patent Office: 2,098 Days
• Field of Search: 600/323, 600/331, 600/336, 250/339.09, 250/341.1, 250/341.5, 356/41, 356/319
• US Class Current: 600/331
• CPC Class Codes: A61B 5/14553 specially adapted for cerebral tissue

Abstract

A method and apparatus for non-invasively determining the blood oxygenation within a subject'"'"'s tissue is provided that utilizes a near infrared spectrophotometric (NIRS) sensor capable of transmitting a light signal into the tissue of a subject and sensing the light signal once it has passed through the tissue via transmittance or reflectance.

Claims

1. A method for determining blood oxygenation within a subject'"'"'s tissue, said method comprising the steps:

transmitting a light signal with a near infrared spectrophotometric light source at a plurality of wavelengths into the subject'"'"'s tissue;

receiving light energy with a first light signal detector and a second light signal detector, which light energy corresponds to the light signal after the light signal has passed through the subject'"'"'s tissue, and wherein the light source is spaced from the first light signal detector by a first distance, and the light source is spaced from the second light signal detector by a second distance wherein the second distance is greater than the first distance; and

processing the light energy received at the plurality of wavelengths, including using wavelength dependent sensor calibration constants representative of energy losses incurred by the light signal passing through the subject'"'"'s tissue, to determine the blood oxygenation within the subject'"'"'s tissue.

2. The method of claim 1, wherein the processing includes the determination of the blood oxygen saturation level within the subject'"'"'s tissue.

3. The method of claim 1, wherein the processing step includes determining the wavelength dependent sensor calibration constants.

4. The method of claim 3, wherein the step of determining the wavelength dependent sensor calibration constants includes determining the wavelength dependent sensor calibration constants using empirical data or a reference sample.

5. The method of claim 1, wherein the wavelength dependent sensor calibration constants are operable to calibrate the sensor for use on a plurality of different subjects without recalibration.

6. The method of claim 1, wherein the processing step includes determining one or both of oxyhemoglobin concentration and deoxyhemoglobin concentration within the subject'"'"'s tissue.

7. The method of claim 6, wherein the concentrations of one or both of oxyhemoglobin and deoxyhemoglobin are determined by determining values of oxyhemoglobin and deoxyhemoglobin at a first point in time, and the changes in oxyhemoglobin and deoxyhemoglobin at a second point in time later than the first point in time.

8. The method of claim 1, further comprising the step of determining the arterial oxygen saturation within the subject using a pulse oximeter, and processing the arterial oxygen saturation with the light energy received at the plurality of wavelengths, to determine the venous blood oxygen saturation level within the subject'"'"'s tissue.

9. A method for determining blood oxygenation within a subject'"'"'s tissue, said method comprising the steps:

transmitting a light signal with a near infrared spectrophotometric light source, the light signal including at least a first wavelength, a second wavelength, and a third wavelength, into the subject'"'"'s tissue;

receiving light energy with a first light signal detector and a second light signal detector, which light energy corresponds to the light signal after the light signal has passed through the subject'"'"'s tissue, and wherein the light source is spaced from the first light signal detector by a first distance, and the light source is spaced from the second light signal detector by a second distance wherein the second distance is greater than the first distance; and

processing the light energy received at the first, second, and third wavelengths, including determining the difference in attenuation of the light signal between the first wavelength and second wavelength, and between the first wavelength and the third wavelength, and determining wavelength dependent sensor calibration constants to compensate for energy losses, to determine the blood oxygenation within the subject'"'"'s tissue.

10. The method of claim 9, wherein the processing includes the determination of the blood oxygen saturation level within the subject'"'"'s tissue.

11. The method of claim 9, wherein the wavelength dependent sensor calibration constants are subject independent.

12. The method of claim 9, wherein the step of processing the light energy received includes contrasting a signal detected at the first signal detector from a signal detected at the second light signal detectors for each discrete wavelength.

13. The method of claim 9, further comprising the step of determining one or both of an oxyhemoglobin concentration and a deoxyhemoglobin concentration within the subject'"'"'s tissue.

14. The method of claim 9, further comprising the step of determining an arterial oxygen saturation within the subject'"'"'s tissue using a pulse oximeter.

15. The method of claim 14, further comprising the step of determining a venous oxygen saturation within the subject'"'"'s tissue using the arterial oxygen saturation determined using the pulse oximeter.

16. A spectrophotometric examination device, comprising:

a light signal transmitter operable to transmit at least one light signal at a plurality of discrete wavelengths;

a first light signal detector operable to detect the light signal, and produce at least one detected signal corresponding to the light signal, which first light signal detector is located a first distance from the light signal transmitter;

a second light signal detector operable to detect the light signal, and produce at least one detected signal corresponding to the light signal, which second light signal detector is located a second distance from the light signal transmitter, and the second distance is greater than the first distance; and

a processor having an algorithm for determining the blood oxygenation in a subject'"'"'s tissue, the algorithm being operable to process detected signals at a plurality of discrete wavelengths, and the algorithm including a plurality of wavelength dependent calibration constants to compensate for energy losses incurred by the light signals passing through the subject'"'"'s tissue.

17. The device of claim 16, wherein the algorithm is operable to determine the blood oxygen saturation level within the subject'"'"'s tissue.

18. The device of claim 16, wherein the light signal transmitter is operable to transmit the light signal at least three discrete wavelengths.

19. The device of claim 16, wherein the wavelength dependent calibration constants are subject independent.

20. The device of claim 16, wherein the energy losses are attributable at least in part to one or more of light scattering, absorption from biological compounds, and apparatus variability.

21. The device of claim 16, wherein the algorithm is operable to process the detected signal at each discrete wavelength, by contrasting a signal detected at the first signal detector from a signal detected at the second light signal detectors for each discrete wavelength.

22. The device of claim 16, wherein the algorithm is operable to determine the total concentration of one or both of oxyhemoglobin and deoxyhemoglobin.

23. The device of claim 16, further comprising a pulse oximeter operable to determine arterial oxygen saturation within the subject.

24. The device of claim 16, wherein the algorithm is operable to determine a venous oxygen saturation within the subject'"'"'s tissue using the arterial oxygen saturation determined using the pulse oximeter.

25. The device of claim 16, wherein the wavelength dependent calibration constants are based on empirical data or a reference sample.

26. The device of claim 16, wherein the energy losses are selected from the group consisting of absorption from background biological compounds, and apparatus variability.

27. The device of claim 16, wherein the calibration constants are operable to calibrate the device for use on a plurality of different subjects without recalibration.

28. A spectrophotometric examination device, comprising:

a light signal transmitter operable to transmit at least one light signal, the light signal including at least three discrete wavelengths;

a first light signal detector operable to detect the light signal, and produce at least one detected signal corresponding to the light signal, which first light signal detector is located a first distance from the light signal transmitter;

a second light signal detector operable to detect the light signal, and produce at least one detected signal corresponding to the light signal, which second light signal detector is located a second distance from the light signal transmitter, and the second distance is greater than the first distance; and

a processor having an algorithm for determining the blood oxygenation in a subject'"'"'s tissue, the algorithm being operable to process the light energy received at a plurality of wavelengths, and compensate for energy losses attributable to absorption from biological compounds other than hemoglobin, to determine the blood oxygenation within the subject'"'"'s tissue.

29. The device of claim 28, wherein the algorithm is operable to determine the blood oxygen saturation level within the subject'"'"'s tissue.

30. The device of claim 28, wherein the energy losses are at least partially attributable to one or more of light scattering, absorption from background biological compounds, and apparatus variability.

31. The device of claim 28, wherein the algorithm is operable to calibrate the device for use on a plurality of different subjects without recalibration.