RESULT VALIDATION IN NON-INVASIVE CEREBRAL OXYGENATION LEVEL MONITORING

• US 20090326345A1
• Filed: 06/26/2008
• Published: 12/31/2009
• Est. Priority Date: 06/26/2008
• Status: Abandoned Application

• Current Assignee: 02 Medtech, Inc.
• Original Assignee: O2 Medtech, Inc.
• Inventors: Jaffe, Richard A., Cheng, Xuefeng, Lopez, Jaime R.
• Application Number:
  US12/146,754
• Publication Number:
  US 20090326345A1
• Time in Patent Office: Days
• US Class Current: 600/323
• CPC Class Codes: A61B 5/14553 specially adapted for cerebral tissue
• CPC Class Codes: A61B 5/6814 Head

Abstract

Methods, systems, and related computer program products for optically monitoring a chromophore level in a body part of a patient are described. An optical source introduces optical radiation into the body part, and an optical detector receives optical radiation that has propagated through at least a portion of the body part and produces a first signal representative of the received optical radiation. The first signal is processed to produce a chromophore level metric, which is output on a user display, and is further processed to produce a second signal known to exhibit measurably significant timewise fluctuations corresponding to at least one intrinsic physiological oscillation of the patient when the optical source and the optical detector are in proper optical coupling with the body part. An error condition indication is provided if the measurably significant timewise fluctuations are not present in the second signal.

Claims

1. A method for near-infrared (NIR) cerebral oxygenation level monitoring, comprising:

causing an NIR optical source to introduce NIR optical radiation into the cerebral tissue of a patient for migration toward an NIR optical detector;

receiving a first signal representative of the NIR optical radiation detected by the NIR optical detector;

processing the first signal to produce a cerebral oxygenation level metric and outputting the cerebral oxygenation level metric on a user display;

processing the first signal to generate a second signal therefrom known to exhibit measurably significant timewise fluctuations corresponding to at least one intrinsic physiological oscillation in the patient when said NIR optical source and said NIR optical detector are in proper optical coupling with said cerebral tissue;

detecting whether said measurably significant timewise fluctuations are present in said second signal; and

outputting an indication of an error condition noticeable to a viewer of the user display if said measurably significant timewise fluctuations are not present in said second signal.

2. The method of claim 1, wherein said outputting said indication of the error condition comprises at least one of (i) preventing said outputting of the cerebral oxygenation level metric on the user display, (ii) outputting a visual error indicator on the user display in viewable conjunction with the oxygenation level metric, and (iii) sounding an audible alarm.

3. The method of claim 1, wherein said at least one intrinsic physiological oscillation is selected from the group consisting of intrinsic cardiac oscillations and intrinsic respiratory oscillations.

4. The method of claim 1, wherein said detecting whether the measurably significant timewise fluctuations are present comprises passively filtering said second signal using a bandpass filter corresponding to a frequency range of said intrinsic physiological oscillations.

5. The method of claim 1, wherein said at least one intrinsic physiological oscillation includes an intrinsic cardiac oscillation, and wherein said detecting whether said measurably significant timewise fluctuations are present in said second signal comprises passively filtering said second signal with a bandpass filter extending from about 0.5 Hz-3 Hz.

6. The method of claim 5, wherein said detecting whether said measurably significant timewise fluctuations are present in said second signal further comprises thresholding the bandpass-filtered second signal with a predetermined threshold value.

7. The method of claim 1, wherein said at least one intrinsic physiological oscillation includes an intrinsic respiratory oscillation, and wherein said detecting whether said measurably significant timewise fluctuations are present in said second signal comprises passively filtering said second signal with a bandpass filter extending from about 0.05 Hz-0.5 Hz and assessing a magnitude of the bandpass-filtered second signal.

8. The method of claim 1, wherein said at least one intrinsic physiological oscillation includes both an intrinsic cardiac oscillation and an intrinsic respiratory oscillation, and wherein said detecting whether said measurably significant timewise fluctuations are present in said second signal comprises:

extracting a cardiac component of the second signal having a frequency range between about 0.5-3 Hz;

extracting a respiratory component of the second signal having a frequency range between about 0.05-0.5 Hz; and

thresholding a weighted sum of said cardiac and respiratory components with a predetermined threshold.

9. The method of claim 1, wherein said detecting whether said measurably significant timewise fluctuations are present in said second signal comprises:

receiving a third signal indicative of an externally measured version of said at least one intrinsic physiological oscillation in the patient; and

synchronously detecting said measurably significant timewise fluctuations in said second signal using said third signal as a reference signal.

10. The method of claim 9, wherein said at least one intrinsic physiological oscillation includes an intrinsic cardiac oscillation, and wherein said third signal is acquired using an external cardiac monitor that is functionally separate from said NIR optical source and said NIR optical detector.

11. The method of claim 9, wherein said at least one intrinsic physiological oscillation includes an intrinsic respiratory oscillation, and wherein said third signal is acquired using an external respiratory monitor that is functionally separate from said NIR optical source and said NIR optical detector.

12. A system for near-infrared (NIR) cerebral oxygenation level monitoring, comprising:

an NIR optical source for introducing NIR optical radiation into the cerebral tissue of a patient;

an NIR optical detector for receiving NIR optical radiation that has migrated through at least a portion of the cerebral tissue, said NIR optical detector generating a first signal representative of the received NIR optical radiation;

a first processor configured and adapted to process the first signal to generate a cerebral oxygenation level metric therefrom, said first processor being further configured and adapted to generate a second signal from the first signal, the second signal being known to exhibit measurably significant timewise fluctuations corresponding to at least one intrinsic physiological oscillation of the patient when said NIR optical source and said NIR optical detector are in proper optical coupling with the cerebral tissue;

a user display for displaying the cerebral oxygenation level metric; and

a second processor configured and adapted to detect whether the measurably significant timewise fluctuations are present in the second signal and to cause an indication of an error condition noticeable to a viewer of the user display if said measurably significant timewise fluctuations are not present in said second signal.

13. The system of claim 12, wherein causing the indication of the error condition comprises at least one of (i) causing the user display to at least partially obscure the displayed cerebral oxygenation level metric, (ii) causing the user display to display a visual error indicator in viewable conjunction with the oxygenation level metric, and (iii) causing the user display to sound an audible alarm.

14. The system of claim 12, wherein said at least one intrinsic physiological oscillation is selected from the group consisting of intrinsic cardiac oscillations and intrinsic respiratory oscillations.

15. The system of claim 12, wherein said second processor is configured and adapted to detect whether the measurably significant timewise fluctuations are present in the second signal by passively filtering said second signal using a bandpass filter corresponding to a frequency range of said intrinsic physiological oscillations.

16. The system of claim 12, wherein said second processor is configured and adapted to detect whether the measurably significant timewise fluctuations are present in the second signal by receiving a third signal indicative of an externally measured version of said at least one intrinsic physiological oscillation in the patient and synchronously detecting said measurably significant timewise fluctuations in said second signal using said third signal as a reference signal.

17. A computer program product stored on a computer-readable medium for facilitating patient monitoring, comprising:

computer code for receiving a first signal representative of near-infrared (NIR) optical radiation that has been introduced into the cerebral tissue of a patient by an NIR optical source and that has been detected by an NIR optical detector after migrating through at least a portion of the cerebral tissue theretoward;

computer code for processing the first signal to produce a cerebral oxygenation level metric for output onto a user display;

computer code for processing the first signal to generate a second signal therefrom known to exhibit measurably significant timewise fluctuations corresponding to at least one intrinsic physiological oscillation in the patient when the NIR optical source and the NIR optical detector are in proper optical coupling with the cerebral tissue;

computer code for detecting whether the measurably significant timewise fluctuations are present in the second signal; and

computer code for outputting an indication of an error condition onto the user display if said measurably significant timewise fluctuations are not present in said second signal.

18. The computer program product of claim 17, wherein the indication of the error condition comprises at least one of a visual obscuration of the cerebral oxygenation level metric, a visual error indicator near the oxygenation level metric, and an audible alarm.

19. The computer program product of claim 17, wherein said at least one intrinsic physiological oscillation is selected from the group consisting of intrinsic cardiac oscillations and intrinsic respiratory oscillations.

20. The computer program product of claim 17, wherein computer code for detecting whether the measurably significant timewise fluctuations are present in the second signal comprises:

computer code for receiving a third signal indicative of an externally measured version of said at least one intrinsic physiological oscillation in the patient; and

computer code for synchronously detecting said measurably significant timewise fluctuations in said second signal using said third signal as a reference signal.