Indicators for a spectrophotometric system

• US 8,761,851 B2
• Filed: 12/06/2006
• Issued: 06/24/2014
• Est. Priority Date: 12/06/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cas Medical Systems Incorporated (Edwards Lifesciences Corporation)
• Inventors: Benni, Paul B., Chen, Bo, Kersey, Andrew
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US12/096,132
• Publication Number:
  US 20080300474A1
• Time in Patent Office: 2,757 Days
• Field of Search: 600322-328, 600330-332, 600/334, 600/336, 600339-341
• US Class Current: 600/323
• CPC Class Codes: A61B 5/0073 by tomography, i.e. reconstruction of 3D images from 2D projections A61B5/0066 takes precedence
• CPC Class Codes: A61B 5/14553 specially adapted for cerebral tissue
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence

Abstract

A near-infrared spectrophotometric system (e.g., a cerebral oximeter) includes a sensor portion and a monitor portion. The monitor portion includes a processor that runs an algorithm which utilizes the amount of detected light to determine the value of the oxygen concentration (e.g., the absolute level of oxygen concentration). The monitor portion also includes a visual display that displays the determined oxygen concentration values in various formats. The monitor portion may also include an audible device (e.g., a speaker), that provides audible indications of the determined oxygen concentration values. Various visual indicators may include, for example, color-coded graphs of the determined oxygenation values to alert the system user, for example, whether one hemisphere of the brain, or one or more regions of the brain, is in danger of adverse and potentially permanent damage. Also, data may be pre-processed by selecting the most clinically concerning sensor value (e.g., the sensor with the lowest value), and displaying only that sensor value and its identification on the display screen. Alternatively, an average value of multiple sensor measurements may be displayed. This reduces screen clutter and increases the speed of interpretation by the system user. Also, all sensor values may be averaged, and the average value displayed. The determined oxygenation values may also be provided in an audible format.

Claims

1. A method for non-invasively determining the blood oxygen saturation level within a subject'"'"'s tissue, using a spectrophotometric system that includes a processor, a visual display, and a plurality of sensors, each sensor having at least one light source operable to transmit a light signal into the subject'"'"'s tissue, and at least one light detector operable to sense the light signal after passage through the subject'"'"'s tissue and to produce signal data representative of the sensed light signal, the method comprising the steps of:

positioning the sensors relative to the subject to sense separate regions of the subject;

sensing the subject'"'"'s tissue and determining an absolute oxygen saturation level for each region using sensed signal data from each region;

displaying the oxygen saturation level for a selected region, or an average of the oxygen saturation levels of all of the regions, on the visual display;

comparing the absolute oxygen saturation level of each region to a predetermined value that is based on established data, and which predetermined value is an absolute value independent of oxygen saturation values determined from the subject'"'"'s tissue, and determining if the absolute oxygen saturation level of each region represents an adverse condition relative to the predetermined value;

replacing the oxygen saturation value of the selected region or average value then currently displayed with the absolute oxygen saturation value of the region having the most adverse oxygen saturation value relative to the other regions.

2. The method of claim 1, wherein the predetermined value represents a minimum oxygen saturation value, and the adverse condition represents an oxygen saturation value below the minimum oxygen saturation value.

3. The method of claim 1, wherein the step of displaying the oxygen saturation level includes displaying one or more colors, where each color is associated with a level of oxygen saturation.

4. The method of claim 3, wherein a first color represents a first range of oxygen saturation values, a second color represents a second range of oxygen saturation values, and a third color represents a third range of oxygen saturation values, wherein the first, second, and third ranges are independent of one another, and each color is distinguishable from the other colors.

5. The method of claim 1, further comprising the step of adjusting the predetermined value in relation to one or more physiological parameters of the subject.

6. The method of claim 5, wherein the physiological parameters include the subject'"'"'s temperature.

7. The method of claim 1, further comprising the step of providing an audible indicator of the oxygen saturation level for the region being displayed.

8. The method of claim 7, wherein the audible indicator changes as the oxygen saturation level changes.

9. The method of claim 7, wherein the audible indicator changes in pitch or frequency.

10. The method of claim 1, further comprising the step of providing an audible signal indicating that the display of the oxygen saturation level has changed from the selected region or average, to the region having the most adverse condition.

11. The method of claim 1, further comprising the step of providing an audible signal indicative of the oxygen saturation level for one or more of the regions having an oxygen saturation level not visually displayed.

12. The method of claim 1, further comprising an audible signal indicative of the subject'"'"'s pulse or arterial oxygen saturation level.

13. The method of claim 1, further comprising an audible signal indicative of the subject'"'"'s venous oxygen saturation level of a particular region or average venous oxygen saturation level.

14. A method for non-invasively determining the blood oxygen saturation level within a subject'"'"'s tissue, using a spectrophotometric system that includes a processor, a visual display, and a plurality of sensors, the method comprising the steps of:

positioning the sensors relative to the subject to sense separate regions of the subject;

sensing the subject'"'"'s tissue and determining an absolute oxygen saturation level for each region using signal data produced from each region;

providing a predetermined value for comparison with the absolute oxygen saturation level of each region, which predetermined value is based on established data, and which predetermined value varies depending on a temperature of the subject;

comparing the absolute oxygen saturation level of each region to a predetermined value, and determining if the absolute oxygen saturation level of each region represents an adverse condition relative to the predetermined value; and

selectively displaying the absolute oxygen saturation level for one or more regions on the visual display.

15. The method of claim 14, wherein the region displayed has the most adverse oxygen saturation value relative to the other regions.

16. The method of claim 14, wherein an average of the oxygen saturation levels for the regions is displayed.

17. The method of claim 16, further comprising the step of replacing the oxygen saturation value of the region or average value then currently displayed with the oxygen saturation value of the region having the most adverse oxygen saturation value relative to the other regions.

18. A method for non-invasively determining the blood oxygen saturation level within a subject'"'"'s tissue, using a spectrophotometric system that includes a processor, a visual display, and a plurality of sensors, the method comprising the steps of:

positioning the sensors relative to the subject to sense separate regions of the subject;

spectrophotometrically sensing the subject'"'"'s tissue and determining an absolute oxygen saturation level for each region using sensed signal data from each region;

displaying the absolute oxygen saturation level for a selected region, or an average of the absolute oxygen saturation levels of all of the regions, on the visual display;

comparing the absolute oxygen saturation level of the regions relative to each other, selecting a maximum absolute oxygen saturation value and a minimum absolute oxygen saturation value, and determining a difference between the maximum and minimum values; and

comparing the difference to a predetermined value, and if the difference exceeds the predetermined value, replacing the absolute oxygen saturation value of the selected region or average value then currently displayed with the minimum absolute oxygen saturation value.