IP Library Granted Patent US 9,913,601
Granted Patent B2
US 9,913,601 · App. 13/758,511 · Granted Mar 13, 2018

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

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Quick Facts
Patent No.
US 9,913,601
App. No.
13/758,511
Granted
Mar 13, 2018
Kind
B2
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 (32)

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.

Assignments (8)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 25, 2025
From: EDWARDS LIFESCIENCES CORPORATION; EDWARDS LIFESCIENCES LLC; EDWARDS LIFESCIENCES SÀRL; EDWARDS LIFESCIENCES HOLDING B.V.
To: BD SWITZERLAND SARL
Reel/Frame 072920/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 4, 2019
From: CAS MEDICAL SYSTEMS, INC.
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 050635/0654 →
RELEASE OF SECURITY INTEREST Recorded May 16, 2018
From: SOLAR CAPITAL LTD.
To: CAS MEDICAL SYSTEMS, INC.
Reel/Frame 045823/0342 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 19, 2017
From: BENNI, PAUL B.
To: CAS MEDICAL SYSTEMS, INC.
Reel/Frame 044431/0123 →
PATENT SECURITY AGREEMENT Recorded Jun 30, 2016
From: CAS MEDICAL SYSTEMS, INC.
To: SOLAR CAPITAL LTD.
Reel/Frame 039221/0004 →
ASSIGNMENT OF INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded May 16, 2016
From: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS RETIRING AGENT
To: SOLAR CAPITAL LTD., AS SUCCESSOR AGENT
Reel/Frame 038711/0067 →
ASSIGNMENT OF INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Nov 15, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, AS RETIRING AGENT
To: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS SUCCESSOR AGENT
Reel/Frame 037112/0159 →
SECURITY INTEREST Recorded Jun 27, 2014
From: CAS MEDICAL SYSTEMS, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT
Reel/Frame 033247/0323 →