IP Library Granted Patent US 8,396,526
Granted Patent B2
US 8,396,526 · App. 11/914,074 · Granted Mar 12, 2013

Method for spectrophotometric blood oxygenation monitoring

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Quick Facts
Patent No.
US 8,396,526
App. No.
11/914,074
Granted
Mar 12, 2013
Kind
B2
Abstract

According to the present invention, a method and apparatus for non-invasively determining the blood oxygen saturation level within a subject's tissue is provided. The method comprises the steps of: 1) providing a near infrared spectrophotometric sensor operable to transmit light along a plurality of wavelengths into the subject's tissue; 2) sensing the light transmitted into the subject's tissue using the sensor, and producing signal data representative of the light sensed from the subject's tissue; 3) processing the signal data to account for physical characteristics of the subject; and 4) determining the blood oxygen saturation level within the subject's tissue using a difference in attenuation between the wavelengths. The apparatus includes a sensor having a light source and at least one light detector, which sensor is operably connected to a processor. The sensor is operable to transmit light along a plurality of wavelengths into the subject's tissue, and produce signal data representative of the light sensed from the subject's tissue. The algorithm is operable to process the signal data to account for the physical characteristics of the subject being sensed.

Claims (32)

1. A method for non-invasively determining a blood oxygen saturation level of the microvasculature within a subject's tissue, comprising the steps of:

providing a spectrophotometric sensor operable to transmit light into the subject's tissue, and to sense the light;

detecting light after passage through the subject's tissue using the sensor, and producing initial signal data from the light sensed;

calibrating the sensor to that particular subject using the initial signal data, thereby accounting for the specific physical characteristics of the particular subject's tissue being sensed; and

subsequent to calibrating the sensor,

using the calibrated sensor to determine the blood oxygen saturation level within the subject's tissue.

2. The method of claim 1 , wherein the physical characteristics of the subject's tissue include pigmentation of skin and tissue disposed below the skin.

3. The method of claim 2 , wherein the processing calibrating step includes the use of absorption coefficients for pigmentation in the subject's tissue.

4. The method of claim 3 , wherein the calibrating step includes determining one or more calibration constants using the absorption coefficients for pigmentation, which calibration constants are used to within the step of determining the blood oxygen saturation level within the subject's tissue.

5. A method for non-invasively determining a blood oxygen saturation level of the microcirculation within a subject's tissue using a spectrophotometric sensor operable to transmit light into the subject's tissue, and to sense the light, the method comprising the steps of:

sensing the subject's tissue using the sensor, and producing initial signal data there from, which signal data is attributable to non-pulsatile blood flow within the microcirculation of the subject's tissue;

calibrating the sensor to that particular subject using the initial signal data, thereby accounting for the specific physical characteristics of the particular subject's tissue being sensed; and

subsequent to calibrating the sensor,

determining the blood oxygen saturation level within the subject's tissue using the calibrated sensor.

6. The method of claim 5 , wherein the physical characteristics of the subject's tissue comprise pigmentation of skin and tissue disposed below the skin.

7. The method of claim 6 , wherein the calibrating step includes the use of absorption coefficients for pigmentation in the subject's tissue.

8. The method of claim 5 , wherein the step of determining the blood oxygen saturation level within the subject's tissue comprises processing signal data other than the initial signal data.

9. The method of claim 8 , wherein the blood oxygen saturation level within the subject's tissue is determined using a difference in attenuation between a first of the wavelengths and each of the other of the wavelengths.

10. A method for non-invasively determining a hemoglobin concentration level of the microcirculation within a subject's tissue, comprising the steps of:

providing a spectrophotometric sensor operable to transmit light into the subject's tissue, and to sense the light;

sensing the subject's tissue using the sensor, and producing initial signal data from the sensing, which initial signal data is attributable to non-pulsatile blood flow within the microcirculation of the subject's tissue; and

calibrating the sensor to that particular subject using the initial signal data, thereby accounting for the specific physical characteristics of the particular subject's tissue being sensed; and

subsequent to calibrating the sensor,

determining the concentration of at least one of oxyhemoglobin and deoxyhemoglobin of the microvasculature within the subject's tissue using the calibrated sensor.

11. The method of claim 10 , further including the step of determining a blood oxygen saturation level within the subject's tissue using the determined concentrations of oxyhemoglobin and deoxyhemoglobin and the initial signal data.

12. An apparatus for non-invasively determining a blood oxygen saturation level of the microcirculation within a subject's tissue, comprising:

at least one spectrophotometric sensor having at least one light source and at least one light detector, wherein the light source is operable to transmit light along a plurality of wavelengths into the subject's tissue, and the light detector is operable to detect light from the light source after the light has traveled through the subject's tissue, and the sensor is operable to produce signal data attributable to non-pulsatile blood flow within the microcirculation of the subject's tissue from the detected light; and

a processor operably connected to the at least one sensor, wherein the processor is adapted to sense the subject's tissue using the sensor, and produce initial signal data from the sensing, which initial signal data is attributable to non-pulsatile blood flow within the microcirculation of the subject's tissue, and to calibrate the sensor to that particular subject using the initial signal data, thereby accounting for the specific physical characteristics of the particular subject's tissue being sensed, and subsequent to calibrating the sensor, determine the concentration of the blood oxygen saturation level of the microvasculature within the subject's tissue using the calibrated sensor.

13. The apparatus of claim 12 , wherein the physical characteristics of the subject's tissue comprise pigmentation.

14. The apparatus of claim 13 , wherein the algorithm utilizes absorption coefficients for pigmentation in the subject's tissue.

15. The apparatus of claim 14 , wherein the algorithm is operable to process the signal data to determine one or more calibration constants using the absorption coefficients for pigmentation, and operable to determine the blood oxygen saturation level within the subject's tissue using the calibration constants.

16. The apparatus of claim 15 , wherein the algorithm is operable to determine the blood oxygen saturation level within the subject's tissue using signal data other than that used to create to the one or more calibration constants.

Assignments (12)
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 →
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 →
SECURITY INTEREST Recorded Mar 28, 2016
From: CAS MEDICAL SYSTEMS, INC.
To: HEALTHCARE FINANCIAL SOLUTIONS, LLC (AS SUCCESSOR-IN-INTEREST TO GENERAL ELECTRIC CAPITAL CORPORATION), AS AGENT
Reel/Frame 038115/0439 →
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 →
RELEASE OF SECURITY INTEREST Recorded Jun 30, 2011
From: FIRST NIAGARA BANK, N.A. SUCCESSOR BY MERGER TO NEWALLIANCE BANK
To: CAS MEDICAL SYSTEMS, INC.
Reel/Frame 026525/0955 →
CONFIRMATORY LICENSE Recorded Dec 16, 2010
From: CAS MEDICAL SYSTEMS, INC.
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 025498/0820 →
SECURITY AGREEMENT Recorded Mar 25, 2010
From: CAS MEDICAL SYSTEMS, INC.
To: NEWALLIANCE BANK
Reel/Frame 024128/0648 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 31, 2008
From: BENNI, PAUL B.
To: CAS MEDICAL SYSTEMS, INC.
Reel/Frame 020728/0846 →