Method for spectrophotometric blood oxygenation monitoring

• US 8,396,526 B2
• Filed: 05/10/2006
• Issued: 03/12/2013
• Est. Priority Date: 05/12/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cas Medical Systems Incorporated (Edwards Lifesciences Corporation)
• Inventors: Benni, Paul
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US11/914,074
• Publication Number:
  US 20090281403A1
• Time in Patent Office: 2,498 Days
• Field of Search: 600/323, 600/331
• US Class Current: 600/323
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/14553 specially adapted for cerebral tissue
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: G01N 2021/3144 for oxymetry
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: G01N 21/49 within a body or fluid

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

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.