METHOD AND APPARATUS FOR DETERMINING AN OXYGEN DESATURATION EVENT

• US 20120271130A1
• Filed: 04/11/2012
• Published: 10/25/2012
• Est. Priority Date: 04/11/2011
• Status: Abandoned Application

• Current Assignee: Cas Medical Systems Incorporated (Edwards Lifesciences Corporation)
• Original Assignee: Cas Medical Systems Incorporated (Edwards Lifesciences Corporation)
• Inventors: Benni, Paul
• Application Number:
  US13/444,509
• Publication Number:
  US 20120271130A1
• Time in Patent Office: Days
• US Class Current: 600/324
• CPC Class Codes: A61B 2503/045 Newborns, e.g. premature baby monitoring
• CPC Class Codes: A61B 5/14551 for measuring blood gases

Abstract

A method and apparatus for determining an index indicative of a subject'"'"'s response to an oxygen desaturation condition is provided. The method includes the steps of: a) providing a NIRS tissue sensor, a pulse oximetry sensor, and a processor in communication with the NIRS tissue sensor and the pulse oximetry sensor; b) sensing the subject'"'"'s tissue using the NIRS tissue sensor and producing first signals; c) sensing the subject'"'"'s tissue using the pulse oximetry sensor and producing second signals; d) processing the first signals to determine a change in tissue oxygen saturation values, processing the second signals to determine a change in arterial oxygen saturation values; and e) determining the index indicative of the subject'"'"'s response to the oxygen desaturation condition using the change in tissue oxygen saturation values and the change in arterial oxygen saturation values.

Claims

1. A method for determining an index indicative of a subject'"'"'s response to an oxygen desaturation condition, the method comprising the steps of:

providing a NIRS tissue sensor, a pulse oximetry sensor, and a processor in communication with the NIRS tissue sensor and the pulse oximetry sensor;

sensing the subject'"'"'s tissue using the NIRS tissue sensor during a period of time, and producing first signals that are indicative of a tissue oxygen saturation value during the period of time;

sensing the subject'"'"'s tissue using the pulse oximetry sensor during the period of time, and producing second signals that are indicative of the subject'"'"'s arterial oxygen saturation during the period of time;

processing the first signals to determine a change in tissue oxygen saturation values over the period of time, processing the second signals to determine a change in arterial oxygen saturation values over the period of time; and

determining the index indicative of the subject'"'"'s response to the oxygen desaturation condition using the change in tissue oxygen saturation values and the change in arterial oxygen saturation values.

2. The method of claim 1, wherein the determining step includes the step of comparing the change in tissue oxygen saturation values and the change in arterial oxygen saturation values over the period of time.

3. The method of claim 2, wherein the step of comparing includes determining a ratio of the change in tissue oxygen saturation values over the change in arterial oxygen saturation values, over the period of time.

4. The method of claim 2, further comprising the step of providing clinical data based on the comparison value.

5. The method of claim 2, wherein the step of determining an index indicative of the subject'"'"'s response to the oxygen desaturation condition includes determining a relative rate of change between the tissue oxygen saturation values and the arterial oxygen saturation values.

6. The method of claim 2, wherein the step of determining the index utilizes one or more of a graph, a mathematical equation, and a database.

7. The method of claim 2, further comprising the step of producing clinical data based on a comparison of the index and a characteristic of the subject.

8. The method of claim 7, wherein the characteristic of the subject is one or more of the study weight of the subject, the study gestational age of the subject, the number of days old the subject was at the time of the sensing, the subject'"'"'s birth weight, and the birth gestational age.

9. The method of claim 1, including the step of determining a trend of the oxygen desaturation condition.

10. A method for non-invasively determining the ability of a subject to adapt to brief systemic hypoxia and/or ischemia events, or a longer term adaptation to abnormal physiology, the method comprising the steps of:

providing a NIRS tissue sensor, a pulse oximetry sensor, and a processor in communication with the NIRS tissue sensor and the pulse oximetry sensor;

sensing the subject'"'"'s tissue using the NIRS tissue sensor, and producing a first signal that is indicative of an oxygen saturation value of the subject'"'"'s tissue;

sensing the tissue using the pulse oximetry sensor, and producing a second signal that is indicative of the subject'"'"'s arterial oxygen saturation;

processing the first and second signals to determine a mean tissue oxygen saturation value for each of a number of predetermined arterial oxygen saturation values;

calculating a rate of change between the mean tissue oxygen saturation values and a rate of change for the arterial oxygen saturation values corresponding to the tissue oxygen saturation values; and

determining an ability of the subject'"'"'s body to adapt to systemic hypoxia events.

11. An apparatus for determining an index indicative of the subject'"'"'s response to an oxygen desaturation condition, comprising:

a NIRS tissue sensor operable to sense the subject'"'"'s tissue during a period of time, and produce first signals indicative of a tissue oxygen saturation value during the period of time;

a pulse oximetry sensor operable to sense the subject'"'"'s tissue during the period of time, and produce second signals indicative of the subject'"'"'s arterial oxygen saturation during the period of time; and

a processor in communication with the NIRS tissue sensor and the pulse oximetry sensor, which processor is adapted to process the first signals to determine a change in tissue oxygen saturation values over the period of time, and to process the second signals to determine a change in arterial oxygen saturation values over the period of time, and to determine the index indicative of the subject'"'"'s response to an oxygen desaturation condition using the change in tissue oxygen saturation values and the change in arterial oxygen saturation values.

12. The apparatus of claim 11, wherein the processor is further adapted to compare the change in tissue oxygen saturation values and the change in arterial oxygen saturation values over the period of time.

13. The apparatus of claim 12, wherein the processor is adapted to determine a ratio of the change in tissue oxygen saturation values over the change in arterial oxygen saturation values, over the period of time.

14. The apparatus of claim 11, wherein the processor is further adapted to produce clinical data based on the index.

15. The apparatus of claim 11, wherein the processor is adapted to determine a relative rate of change between the tissue oxygen saturation values and the arterial oxygen saturation values.

16. The apparatus of claim 11, wherein the processor is adapted to determine the index using one or more of a graph, a mathematical equation, and a database.

17. The apparatus of claim 11, wherein the processor is adapted to produce clinical data based on a comparison of the index and a characteristic of the subject.

18. The apparatus of claim 17, wherein the characteristic of the subject is one or more of the study weight of the subject, the study gestational age of the subject, the number of days old the subject was at the time of the sensing, the subject'"'"'s birth weight, and the birth gestational age.

19. The apparatus of claim 11, wherein the processor is adapted to determine a trend of the oxygen desaturation condition.

20. An apparatus for non-invasively determining the ability of a subject to adapt to brief systemic hypoxia and/or ischemia event, or an longer term adaptation to abnormal physiology, comprising:

a NIRS tissue sensor operable to sense the subject'"'"'s tissue and produce a first signal indicative of an oxygen saturation value of the subject'"'"'s tissue;

a pulse oximetry sensor operable to sense tissue of the subject, and produce a second signal that is indicative of the subject'"'"'s arterial oxygen saturation; and

a processor in communication with the NIRS tissue sensor and the pulse oximetry sensor, which processor is adapted to process the first and second signals to determine a mean tissue oxygen saturation value for each of a number of predetermined arterial oxygen saturation values, and to calculate a rate of change between the mean tissue oxygen saturation values and a rate of change for the arterial oxygen saturation values corresponding to the tissue oxygen saturation values, and to determine an ability of the subject'"'"'s body to adapt to brief systemic hypoxia and/or ischemia event, or an longer term adaptation to abnormal physiology.