Determining tissue oxygen saturation with quality reporting

• US 10,786,187 B2
• Filed: 04/24/2017
• Issued: 09/29/2020
• Est. Priority Date: 04/22/2016
• Status: Active Grant

• Current Assignee: ViOptix, Inc.
• Original Assignee: ViOptix, Inc.
• Inventors: Bechtel, Kate LeeAnn, Margiott, Alex Michael, Keating, Jennifer Elizabeth, Shultz, Kimberly Merritt, Coleridge, Scott, Heanue, Joseph
• Primary Examiner(s): Winakur, Eric F
• Assistant Examiner(s): Liu, Chu Chuan
• Application Number:
  US15/495,194
• Publication Number:
  US 20170303835A1
• Time in Patent Office: 1,254 Days
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0425 Ergonomically shaped housings A61B2560/0418 takes precedence
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2562/0238 Optical sensor arrangements for performing transmission measurements on body tissue
• CPC Class Codes: A61B 2562/0242 for varying or adjusting the optical path length in the tissue
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick

Abstract

An oximeter probe determines an oxygen saturation for the tissue and determines a quality value for the oxygen saturation and associated measurements of the tissue. The quality value is calculated from reflectance data received at the detectors of the oximeter probe. The oximeter probe then displays a value for the oxygen saturation with the error value to indicate a quality level for the oxygen saturation and associated values used to calculate oxygen saturation.

Claims

1. A method comprising:

providing a tissue oximeter device comprising a nonvolatile memory storing simulated reflectance curves, wherein the nonvolatile memory retains the simulated reflectance curves even after the device is powered off;

emitting light from at least one source of the tissue oximeter device into a tissue to be measured;

receiving at a plurality of detectors of the tissue oximeter device light reflected from the tissue in response to the emitted light;

generating, by the detectors, a plurality of detector responses from the reflected light;

fitting the detector responses to the simulated reflectance curves stored in the nonvolatile memory to determine an absorption coefficient value for the tissue;

calculating an oximetry value for the tissue from the absorption coefficient value;

based on the absorption coefficient value, calculating a quality metric value for the oximetry value; and

displaying, by a processor on a display of the oximeter device, the oximetry value and the quality metric value for the oximetry value.

2. The method of claim 1 comprising:

providing, in the nonvolatile memory, values for a predetermined detector relationship for the detectors and the reflected light, wherein the nonvolatile memory retains the values for the predetermined detector relationship even after the device is powered off;

comparing the detector responses for the detectors with the values for the predetermined detector relationship in the nonvolatile memory; and

based on the comparison of the detector responses with the values for the predetermined detector relationship stored in the nonvolatile memory, determining, by the processor, the quality metric value.

3. The method of claim 1 comprising performing, by the processor of the oximeter device, a ratiometric calculation for calculating the quality metric value.

4. The method of claim 1 wherein the oximetry value is an oxygen saturation value for the tissue.

5. The method of claim 1 comprising calculating, by the processor, an error value from the fit of the detector responses to the simulated reflectance curves, wherein the quality metric value is the error value.

6. The method of claim 5 wherein calculating the error value comprises, using by the processor, a Tiknonov regularization calculation.

7. The method of claim 1 wherein the quality metric value is a moving average value of quality metric values.

8. The method of claim 1 wherein displaying the quality metric value comprises displaying the quality metric value as a percentage value via a bar graph.

9. A system comprising:

an oximeter device comprising a probe tip comprising source structures and detector structures on a distal end of the device and a display proximal to the probe tip, wherein the oximeter device is configured to;

transmit light from a light source of the oximeter device into a first tissue at a first location to be measured;

receive light at a detector of the oximeter device that is reflected by the first tissue in response to the transmitted light;

based on the response of the detector to the transmitted light, use simulated reflectance curves stored in the oximeter device to determine an absorption coefficient value;

determine an oxygen saturation value for the first tissue based on the absorption coefficient value;

based on the absorption coefficient value, calculate a quality metric value associated with the determined oxygen saturation value for the first tissue; and

display the oxygen saturation value and the quality metric value associated with the displayed oxygen saturation value on the display.

10. The system of claim 9 wherein the quality metric value is displayed as a percentage value.

11. The system of claim 9 wherein the quality metric value is displayed as quality bars in the display.

12. The system of claim 9 wherein a measured information is obtained about the first tissue based on the transmitted and received light, and the quality metric value is based on a closeness of fit of the measured information to a set of predetermined curves stored in a memory of the oximeter device.

13. The system of claim 9 wherein the use simulated reflectance curves stored in the oximeter device to determine an absorption coefficient value for the tissue comprises curve fitting.

14. The system of claim 9 wherein the display the oxygen saturation value and the quality metric value associated with the displayed oxygen saturation value on the display comprises:

displaying the oxygen saturation value and not the quality metric value on the display at the same time, and after a predetermined time period, displaying the quality metric value associated with the previously displayed oxygen saturation value on the display.

15. The system of claim 9 wherein the display the oxygen saturation value and the quality metric value associated with the displayed oxygen saturation value on the display comprises:

displaying the oxygen saturation value and not the quality metric value on the display at the same time, and upon a user pressing a button of the oximeter device, displaying the quality metric value associated with the previously displayed oxygen saturation value on the display.

16. A method comprising:

providing a tissue oximeter device comprising a nonvolatile memory storing simulated reflectance curves, wherein the nonvolatile memory retains the simulated reflectance curves even after the device is powered off;

emitting light from at least one source of the tissue oximeter device into a tissue to be measured;

receiving at a plurality of detectors of the tissue oximeter device light reflected from the tissue in response to the emitted light;

generating, by the detectors, a plurality of detector responses from the reflected light;

fitting the detector responses to the simulated reflectance curves stored in the nonvolatile memory to determine a plurality of absorption coefficient values for the tissue for a plurality of oximeter measurements;

calculating an oximetry value for the tissue from a first absorption coefficient value of the plurality of absorption coefficient values for a first oximeter measurement of the plurality of oximeter measurements;

based on the first absorption coefficient value of the plurality of absorption coefficient values, calculating a first quality metric value for the oximetry value for the first oximeter measurement;

calculating a second quality metric value based on the first quality metric value and at least a second absorption coefficient value of the plurality of absorption coefficient values for at least a second oximeter measurement; and

displaying on a display of the oximeter device, the oximetry value and the second quality metric value for the oximetry value.

17. The method of claim 16 wherein the second oximeter measurement is made prior to the first oximeter measurement.

18. The method of claim 16 wherein calculating the second quality metric value is based on the first quality metric value, the second absorption coefficient value of the plurality of absorption coefficient values for the second oximeter measurement, and a third absorption coefficient value of the plurality of absorption coefficient values for a third oximeter measurement.

19. The method of claim 18 wherein the second and third oximeter measurements are made prior to the first oximeter measurement.

20. The method of claim 18 wherein the second quality metric value is based on a time average of the first, second, and third absorption coefficient values for the first, second, and third oximeter measurements.