Method and apparatus for monitoring a blood oxygen saturation level relative to a saturation threshold value

• US 9,913,601 B2
• Filed: 02/04/2013
• Issued: 03/13/2018
• Est. Priority Date: 02/03/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cas Medical Systems Incorporated (Edwards Lifesciences Corporation)
• Inventors: Benni, Paul B.
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US13/758,511
• Publication Number:
  US 20130204105A1
• Time in Patent Office: 1,863 Days
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14553 specially adapted for cerebral tissue
• 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 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take 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 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients

Abstract

A method and apparatus for monitoring a blood oxygen saturation level within a subject'"'"'s tissue is provided. The method includes the steps of: a) sensing the subject'"'"'s tissue using a near infrared spectrophotometric oximeter, and producing a value representative of the oxygen saturation level within the sensed tissue; b) comparing the determined saturation value to a predetermined threshold oxygen saturation value; and c) determining at least one of a time under threshold (TUT) value or an area under threshold (AUT) value using the determined saturation value and the threshold value.

Claims

1. A method for monitoring a blood oxygen saturation level within a subject'"'"'s tissue during a period of time, comprising:

providing a near infrared spectrophotometric (NIRS) apparatus that includes at least one sensor having at least one light source and at least one light detector, an analyzer having at least one processor, and an input device, wherein the at least one processor is in signal communication with the at least one sensor and the input device;

applying the at least one sensor to a skin surface of the subject;

inputting one or more subject characteristics specific to the subject into the processor using the input device;

using the at least one processor to execute instructions stored in a memory device, which instructions cause the at least one processor to;

control the at least one light source to emit light into the subject'"'"'s tissue and to detect the emitted light after the emitted light has passed through the user'"'"'s tissue using the at least one light detector, wherein the light detector produces signals representative of the detected light;

periodically determine a value representative of the oxygen saturation level within the tissue based on the signals representative of the detected light;

determine a threshold oxygen saturation value based on the one or more subject characteristics specific to the subject;

compare the periodically determined value representative of the oxygen saturation level within the tissue to the determined threshold oxygen saturation value;

determine a cumulative under threshold value for the period of time using a plurality of the periodically determined values representative of the oxygen saturation level and the determined threshold oxygen saturation value; and

communicate to a user the cumulative under threshold value.

2. The method of claim 1, wherein the one or more subject characteristics specific to the subject include one or more of the subject'"'"'s age, weight, height, gender, health, blood pressure, hematocrit, ethnicity, and tobacco usage status.

3. The method of claim 2, wherein the instructions cause the at least one processor to determine the threshold oxygen saturation value using the one or more subject characteristics specific to the subject.

4. The method of claim 1, wherein the cumulative under threshold value for the period of time is a time under threshold (TUT) value.

5. The method of claim 1, wherein the cumulative under threshold value for the period of time is an area under threshold (AUT) value which AUT value is representative of an amount of time under threshold and a magnitude of tissue oxygen deficit during the amount of time under threshold.

6. The method of claim 1, wherein the instructions further cause the at least one processor to determine an under threshold rate of change value based on a plurality of cumulative under threshold values.

7. The method of claim 1, wherein the instructions further cause the at least one processor to determine a trend value based on a plurality of cumulative under threshold values, which trend value is indicative of one of an increase, a decrease, or no change in the cumulative under threshold values over time.

8. An apparatus for monitoring a blood oxygen saturation level within a subject'"'"'s tissue during a period of time, comprising:

a near infrared spectrophotometric (NIRS) apparatus that includes at least one sensor having at least one light source and at least one light detector, an analyzer having at least one processor, and an input device, wherein the at least one processor is in signal communication with the at least one sensor and the input device;

wherein the at least one processor is in communication with a memory device storing instructions, which instructions when executed cause the at least one processor to selectively;

control the at least one light source to emit light into the subject'"'"'s tissue and to detect the emitted light after the emitted light has passed through the user'"'"'s tissue using the at least one light detector, wherein the light detector produces signals representative of the detected light;

periodically determine a value representative of the oxygen saturation level within the tissue based on the signals representative of the detected light;

determine a threshold oxygen saturation value based on one or more subject characteristics specific to the subject input into the at least one processor using the input device;

compare the periodically determined value representative of the oxygen saturation level within the tissue to the determined threshold oxygen saturation value;

determine a cumulative under threshold value for the period of time using a plurality of the periodically determined values representative of the oxygen saturation level and the determined threshold oxygen saturation value; and

communicate to a user the cumulative under threshold value.

9. The apparatus of claim 8, wherein the one or more subject characteristics specific to the subject include one or more of the subject'"'"'s age, weight, height, gender, health, blood pressure, hematocrit, ethnicity, and tobacco usage status.

10. The apparatus of claim 8, wherein the instructions cause the at least one processor to determine the threshold oxygen saturation value using the one or more subject characteristics specific to the subject.

11. The apparatus of claim 8, wherein the cumulative under threshold value for the period of time is a time under threshold (TUT) value.

12. The apparatus of claim 8, wherein the cumulative under threshold value for the period of time is an area under threshold (AUT) value which AUT value is representative of an amount of time under threshold and a magnitude of tissue oxygen deficit during the amount of time under threshold.

13. The apparatus of claim 8, wherein the instructions further cause the at least one processor to determine an under threshold rate of change value based on a plurality of cumulative under threshold values.

14. The apparatus of claim 8, wherein the instructions further cause the at least one processor to determine a trend value based on a plurality of cumulative under threshold values, which trend value is indicative of one of an increase, a decrease, or no change in the cumulative under threshold values over time.