Patient Monitoring Using Combination of Continuous Wave Spectrophotometry and Phase Modulation Spectrophotometry

• US 20100198029A1
• Filed: 02/05/2010
• Published: 08/05/2010
• Est. Priority Date: 02/05/2009
• Status: Abandoned Application

• Current Assignee: O2 Medtech, Inc.
• Original Assignee: O2 Medtech, Inc.
• Inventors: WANG, Shih-Ping
• Application Number:
  US12/701,274
• Publication Number:
  US 20100198029A1
• Time in Patent Office: Days
• US Class Current: 600/323
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/14553 specially adapted for cerebral tissue
• CPC Class Codes: A61B 5/6814 Head

Abstract

Non-invasive spectrophotometric monitoring of oxygen saturation levels based on a combination of continuous wave spectrophotometry (CWS) and phase modulation spectrophotometry (PMS) is described. First information representative of absolute oxygen saturation levels in relatively shallow regions of a patient tissue volume are acquired from PMS-based monitoring thereof during a reference interval. Second information representative of non-absolute oxygen saturation levels in relatively deep regions of the tissue volume are acquired from CWS-based monitoring thereof during the reference interval. Based on the first and second information acquired during the reference interval, a mapping is automatically determined between the second information and estimated absolute oxygen saturation metrics for the relatively deep regions. On a continuing basis during a monitoring interval subsequent to the reference interval, the second information continuously acquired from CWS-based monitoring of the tissue volume are continuously mapped into estimated absolute oxygen saturation metrics, which are continuously displayed on a display output.

Claims

1. A method for non-invasive spectrophotometric monitoring of oxygen saturation levels in a tissue volume of a patient during a patient monitoring session, said patient monitoring session including a reference interval and a monitoring interval subsequent to said reference interval, comprising:

receiving, in association with said reference interval, first information acquired from phase modulation spectrophotometry-based (PMS-based) monitoring of the tissue volume, said first information being representative of at least one absolute oxygen saturation level in a respective at least one relatively shallow region of the tissue volume;

receiving, in association with said reference interval, second information acquired from continuous wave spectrophotometry-based (CWS-based) monitoring of the tissue volume, said second information being representative of at least one non-absolute oxygen saturation level in a respective at least one relatively deep region of the tissue volume;

determining, based on said first and second information associated with the reference interval, a mapping between said second information and at least one estimated absolute oxygen saturation metric applicable to the respective at least one relatively deep region of the tissue volume;

receiving, on a continuing basis during the monitoring interval, the second information acquired from the CWS-based monitoring of the tissue volume;

computing, on a continuing basis during the monitoring interval, the at least one estimated absolute oxygen saturation metric applicable to the respective at least one relatively deep region by applying said determined mapping to said second information received during the monitoring interval;

displaying, on a continuing basis during the monitoring interval, said at least one estimated absolute oxygen saturation metric applicable to the respective at least one relatively deep region on an output display.

2. The method of claim 1, the method further comprising:

providing a hybrid PMS-CWS monitoring unit including said output display, a CWS monitoring subsystem including at least one CWS source and at least one CWS detector, a PMS monitoring subsystem including at least one PMS source-detector unit, and a user interface capable of receiving a calibration trigger input from a user;

prior to said reference interval, coupling said at least one CWS source, said at least one CWS detector, and said at least one PMS source-detector unit to the surface of the tissue volume; and

at an end of said reference interval, manually providing the calibration trigger input to the user interface of the hybrid CWS-PMS monitoring unit to instantiate said mapping determination.

3. The method of claim 2, wherein said tissue volume corresponds to the head of the patient, wherein said reference interval is caused to occur during a assumed non-ischemic quiescent period in which cerebral oxygen saturation is more likely to be uniform throughout the head of the patient, and wherein said calibration trigger input is caused to occur prior to instantiation of a medical event during which anomalous conditions may cause ischemic cerebral conditions to occur, whereby said output display of said least one estimated absolute oxygen saturation metric facilitates detection of such cerebral ischemic conditions in deep brain tissue.

4. The method of claim 3, said at least one CWS source and said at least one CWS detector establishing at least one CWS source-detector pair, each CWS source-detector pair corresponding to one of the at least one relatively deep regions and having a source-detector spacing greater than about 6 cm, each PMS source-detector unit corresponding to one of the at least one relatively shallow regions and having a source-detector spacing of less than about 6 cm.

5. The method of claim 4, wherein said mapping determination comprises:

processing said second information associated with said reference interval to generate a reference CWS-based non-absolute oxygen saturation metric for each said at least one relatively deep region;

processing said first information associated with said reference interval to generate a reference PMS-based absolute oxygen saturation metric; and

for each said at least one relatively deep region, computing a fixed scaling factor that, when multiplied by said reference CWS-based non-absolute oxygen saturation metric, results in said reference PMS-based absolute oxygen saturation metric;

and wherein said computing on the continuous basis during the monitoring interval comprises (i) processing the second information acquired during the monitoring interval to generate a current CWS-based non-absolute oxygen saturation metric for each said at least one relatively deep region, and (ii) scaling the current CWS-based non-absolute oxygen saturation metric for each relatively deep region by the fixed scaling factor for that relatively deep region to generate the estimated absolute oxygen saturation metric applicable to that relatively deep region.

6. The method of claim 5, wherein a plurality of said PMS source-detector units are coupled to the surface of the head, and wherein said processing said first information associated with said reference interval to generate the reference PMS-based absolute oxygen saturation metric comprises:

generating a separate PMS-based absolute oxygen saturation metric for the relatively shallow region corresponding to each of the at least one PMS source-detector units; and

computing said reference PMS-based absolute oxygen saturation metric as an average of said separate PMS-based absolute oxygen saturation metrics.

7. The method of claim 5, wherein a plurality of said CWS sources are coupled to the head surface including a first plurality of CWS sources positioned farther than a predetermined threshold distance from a retina of the patient and a second plurality of CWS sources positioned nearer than said predetermined threshold distance from the retina, wherein said first plurality of CWS sources are operated at a maximum source power for the human head according to regulatory guidelines, and wherein said second plurality of CWS sources are operated at source powers that decrease with decreasing distance to the retina.

8. The method of claim 5, wherein a plurality of said CWS source-detector pairs are established around the head corresponding a respective plurality of the relatively deep regions, and wherein said output display includes a separate graphical trace for each of the corresponding estimated absolute oxygen saturation metrics, whereby localization of ischemic conditions in the deep brain tissue during the medical event is facilitated.

9. The method of claim 2, wherein said tissue volume includes both kidneys of the patient, and wherein, for each kidney, a CWS source-detector pair and a PMS source-detector pair are coupled to the surface of the tissue volume near that kidney, said CWS source-detector pair having a source-detector spacing of at least two times a depth of the kidney beneath the tissue volume surface.

10. The method of claim 9, said reference interval being caused to occur during an assumed single-kidney ischemic event, said calibration trigger input being caused to occur prior to treatment thereof or recovery therefrom, wherein said mapping determination comprises:

processing said second information associated with said reference interval to generate a reference CWS-based non-absolute oxygen saturation metric for each said kidney;

identifying one kidney as ischemic and the other kidney as non-ischemic by comparison of said reference CWS-based non-absolute oxygen saturation metrics;

processing said first information associated with said reference interval to generate a reference PMS-based absolute oxygen saturation metric, wherein said reference PMS-based absolute oxygen saturation metric is assigned to one of (i) a PMS-based oxygen saturation metric corresponding to the PMS source-detector pair nearer the non-ischemic kidney, and (ii) an average of the PMS-based oxygen saturation metrics for the PMS source-detector pairs;

computing a first fixed scaling factor that, when multiplied by the reference CWS-based non-absolute oxygen saturation metric for the non-ischemic kidney, results in said reference PMS-based absolute oxygen saturation metric; and

computing a second fixed scaling factor equal to the first scaling factor times a ratio of the CWS-based non-absolute oxygen saturation metric for the ischemic kidney to the CWS-based non-absolute oxygen saturation metric for the non-ischemic kidney;

and wherein, for a duration of said monitoring interval subsequent to said reference interval, said mapping comprises (i) for the non-ischemic kidney, scaling the corresponding CWS-based non-absolute oxygen saturation metric by said first fixed scaling factor to generate the estimated absolute oxygen saturation metric applicable thereto, and (ii) for the ischemic kidney, scaling the corresponding CWS-based non-absolute oxygen saturation metric by said second fixed scaling factor to generate the estimated absolute oxygen saturation metric applicable thereto.

11. The method of claim 1, wherein optical radiation within a wavelength range of 600 nm-1400 nm is used for both said CWS-based monitoring and PMS-based monitoring of the tissue volume.

12. The method of claim 1, wherein optical detection for both said CWS-based monitoring and PMS-based monitoring of the tissue volume is performed using photomultiplier tubes (PMTs).

13. A system for non-invasive spectrophotometric monitoring of oxygen saturation levels in a tissue volume of a patient during a patient monitoring session, the patient monitoring session including a reference interval and a monitoring interval subsequent to the reference interval, comprising:

a phase modulation spectrophotometry (PMS) subsystem for PMS-based monitoring of the tissue volume, the PMS subsystem generating first information representative of at least one absolute oxygen saturation level in a respective at least one relatively shallow region of the tissue volume;

a continuous wave spectrophotometry (CWS) subsystem for CWS-based monitoring of the tissue volume, the CWS subsystem generating second information representative of at least one non-absolute oxygen saturation level in a respective at least one relatively deep region of the tissue volume;

a computer coupled with said PMS subsystem and said CWS subsystem and being programmed to;

(a) determine, based on said first information and said second information as acquired during said reference interval, a mapping between said second information and at least one estimated absolute oxygen saturation metric applicable to the respective at least one relatively deep region of the tissue volume; and

(b) compute, on a continuing basis during the monitoring interval, the at least one estimated absolute oxygen saturation metric applicable to the respective at least one relatively deep region by applying said determined mapping to said second information as acquired during the monitoring interval; and

an output display for displaying, on a continuing basis during the monitoring interval, the at least one estimated absolute oxygen saturation metric applicable to the respective at least one relatively deep region of the tissue volume.

14. The system of claim 13, further comprising a user interface configured to receive a calibration trigger input from a user, the calibration trigger input providing a time point that separates the reference interval from the monitoring interval and causing said computer to instantiate said determination of said mapping.

15. The system of claim 14, wherein said determination of said mapping comprises:

processing said second information acquired during said reference interval to generate a reference CWS-based non-absolute oxygen saturation metric for each said at least one relatively deep region;

processing said first information acquired during said reference interval to generate a reference PMS-based absolute oxygen saturation metric; and

for each said at least one relatively deep region, computing a fixed scaling factor that, when multiplied by said reference CWS-based non-absolute oxygen saturation metric, results in said reference PMS-based absolute oxygen saturation metric;

and wherein said computing on the continuous basis during the monitoring interval comprises (i) processing the second information acquired during the monitoring interval to generate a current CWS-based non-absolute oxygen saturation metric for each said at least one relatively deep region, and (ii) scaling the current CWS-based non-absolute oxygen saturation metric for each relatively deep region by the fixed scaling factor for that relatively deep region to generate the estimated absolute oxygen saturation metric applicable to that relatively deep region.

16. The system of claim 15, wherein said tissue volume corresponds to the head of the patient, wherein said PMS subsystem comprises at least one PMS source-detector pair unit for coupling to the head of the patient, the PMS source-detector pair unit having a source-detector spacing less than about 6 cm, and wherein said CWS subsystem comprises a plurality of CWS sources and a plurality of CWS detectors for coupling to the head of the patient, the CWS sources and CWS detectors establishing a plurality of CWS source-detector pairs, each CWS source-detector pair corresponding to one of the at least one relatively deep regions and having a source-detector spacing greater than about 6 cm.

17. The system of claim 16, said CWS subsystem and said PMS subsystem each use optical radiation within a wavelength range of 600 nm-1400 nm, and wherein each said CWS subsystem and PMS subsystem comprises photomultiplier tubes (PMTs) for performing optical detection.

18. A computer readable medium tangibly embodying one or more sequences of instructions wherein execution of the one or more sequences of instructions by one or more processors causes the one or more processors to facilitate non-invasive spectrophotometric monitoring of oxygen saturation levels in a tissue volume of a patient during a patient monitoring session, said patient monitoring session including a reference interval and a monitoring interval subsequent to said reference interval, including performing the steps of:

receiving, in association with said reference interval, first information acquired from phase modulation spectrophotometry-based (PMS-based) monitoring of the tissue volume, said first information being representative of at least one absolute oxygen saturation level in a respective at least one relatively shallow region of the tissue volume;

receiving, in association with said reference interval, second information acquired from continuous wave spectrophotometry-based (CWS-based) monitoring of the tissue volume, said second information being representative of at least one non-absolute oxygen saturation level in a respective at least one relatively deep region of the tissue volume;

determining, based on said first and second information associated with the reference interval, a mapping between said second information and at least one estimated absolute oxygen saturation metric applicable to the respective at least one relatively deep region of the tissue volume;

receiving, on a continuing basis during the monitoring interval, the second information acquired from the CWS-based monitoring of the tissue volume;

computing, on a continuing basis during the monitoring interval, the at least one estimated absolute oxygen saturation metric applicable to the respective at least one relatively deep region by applying said determined mapping to said second information received during the monitoring interval;

causing to be displayed, on a continuing basis during the monitoring interval, said at least one estimated absolute oxygen saturation metric applicable to the respective at least one relatively deep region on an output display.

19. The computer readable medium of claim 18, wherein said mapping determination comprises:

processing said second information associated with said reference interval to generate a reference CWS-based non-absolute oxygen saturation metric for each said at least one relatively deep region;

processing said first information associated with said reference interval to generate a reference PMS-based absolute oxygen saturation metric; and

for each said at least one relatively deep region, computing a fixed scaling factor that, when multiplied by said reference CWS-based non-absolute oxygen saturation metric, results in said reference PMS-based absolute oxygen saturation metric;

and wherein said computing on the continuous basis during the monitoring interval comprises (i) processing the second information acquired during the monitoring interval to generate a current CWS-based non-absolute oxygen saturation metric for each said at least one relatively deep region, and (ii) scaling the current CWS-based non-absolute oxygen saturation metric for each relatively deep region by the fixed scaling factor for that relatively deep region to generate the estimated absolute oxygen saturation metric applicable to that relatively deep region.

20. The computer readable medium of claim 18, wherein said processing said first information associated with said reference interval to generate the reference PMS-based absolute oxygen saturation metric comprises:

computing from said first information a plurality of local PMS-based absolute oxygen saturation metric corresponding to different relatively shallow regions of the tissue volume; and

computing said reference PMS-based absolute oxygen saturation metric as an average of said local PMS-based absolute oxygen saturation metrics.