Method for spectrophotometric blood oxygenation monitoring of organs in the body

• US 9,364,175 B2
• Filed: 11/24/2010
• Issued: 06/14/2016
• Est. Priority Date: 11/24/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cas Medical Systems Incorporated (Edwards Lifesciences Corporation)
• Inventors: Benni, Paul
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US13/511,928
• Publication Number:
  US 20130023744A1
• Time in Patent Office: 2,029 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• 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

Abstract

A method and apparatus for non-invasively determining a blood oxygen saturation level within an organ of a subject using direct application of a near infrared spectrophotometric sensor is provided. The method includes the steps of: a) transmitting a light signal directly into the subject'"'"'s organ using the sensor; b) sensing a first intensity of the light signal and a second intensity of the light signal, after the light signal travels a predetermined distance through the organ of the subject; c) determining an attenuation of the light signal along multiple different wavelengths using the sensed first intensity and sensed second intensity; d) determining a difference in attenuation of the light signal between wavelengths; and e) determining the blood oxygen saturation level within the subject'"'"'s organ using the difference in attenuation between wavelengths.

Claims

1. A method for non-invasively determining a blood oxygen saturation level within tissue of an internal organ of a subject, comprising the steps of:

applying a near infrared spectrophotometric sensor on an external surface of the internal organ, which sensor includes at least one light source and at least one detector;

operating the sensor to emit light from the light source at an incident light intensity directly into the tissue of the internal organ at a first tissue location, which emitted light includes a first wavelength, a second wavelength, and a third wavelength, and to sense said emitted light at a second tissue location, separated from the first tissue location, which emitted light has traveled through the tissue between the first tissue location and the second tissue location, and to produce signals representative of the intensity of the sensed emitted light;

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

determine an attenuation of the emitted light for each of the first, second, and signals representative of the intensity of the sensed emitted light for each said wavelength;

determine a difference in the attenuation of the emitted light between the first wavelength and the second wavelength and between the first wavelength and the third wavelength; and

determine a blood oxygen saturation level of the organ tissue using the difference in attenuation between the first wavelength and the second wavelength, and the difference in attenuation between the first wavelength and the third wavelength.

2. The method of claim 1, Wherein the sensor applied to the external surface of the organ is configured to interrogate tissue contiguous with the external surface of the organ.

3. The method of claim 2, wherein the sensor has a plurality of light detectors.

4. The method of claim 2, wherein the sensor is configured to be applied to the exterior surface of a heart and to interrogate tissue contiguous with the external surface of the heart.

5. The method of claim 2, wherein the sensor is configured to be applied to the exterior surface of a liver and to interrogate tissue contiguous with the external surface of the liver.

6. The method of claim 2, wherein the sensor is configured to be applied to the exterior surface of a kidney and to interrogate tissue contiguous with the external surface of the kidney.

7. The method of claim 1, wherein the at least one detector is spaced a distance apart from the light source, and wherein the distance is such that the sensed emitted light travels substantially exclusively through the organ tissue.

8. The method of claim 1, wherein the at least one detector includes a first detector spaced a first distance apart from the light source, and a second detector spaced a second distance from the light source, which second distance is greater than the first distance, and wherein the first and second distances are such that the sensed emitted light travels substantially exclusively through the organ tissue.

9. The method of claim 1, further comprising:

wherein the instructions stored in the memory device include a predetermined organ tissue oxygenation level threshold and which instructions further cause the processor to;

compare the predetermined organ tissue oxygenation level threshold and the determined blood oxygen saturation level of the organ tissue.

10. An apparatus for non-invasively determining a blood oxygen saturation level within tissue of an organ of a subject, comprising:

a near infrared spectrophotometric sensor configured to be placed in contact with an external surface of the organ, which sensor has at least one light source and at least one light detector, which light source is operable to transmit a light signal at an incident light intensity that includes a first wavelength, a second wavelength, and a third wavelength, and which light detector is operable to sense the light signal along the first, second, and third wavelengths after the light signal travels a distance through the organ tissue, and produce data signals representative of an intensity of the sensed light signal;

a processor configured to receive the data signals from the sensor, and configured to execute instructions stored in a memory device, which instructions cause the processor to;

determine an attenuation of the emitted light for each of the first second and third wavelengths using a value representative of the incident light intensity and the signals representative of the intensity of the sensed emitted light for each said wavelength;

determine a difference in the attenuation of the emitted light between the first wavelength; and

the second wavelength, and between the first wavelength and the third wavelength; and

determine a blood saturation level of the organ tissue using the difference in attenuation between the first wavelength and the second wavelength, and the difference in attenuation between the first wavelength and the third wavelength.

11. The apparatus of claim 10, wherein the sensor is configured to interrogate the organ tissue contiguous with the external surface of the organ where the sensor is placed in contact.

12. The apparatus of claim 11, wherein the sensor is configured to be applied to the external surface of a heart and to interrogate tissue contiguous with the external surface of the heart.

13. The apparatus of claim 11, wherein the sensor is configured to be applied to the external surface of a liver and to interrogate tissue contiguous with the external surface of the liver.

14. The apparatus of claim 11, wherein the sensor is configured to be applied to the external surface of a kidney and to interrogate tissue contiguous with the external surface of the kidney.

15. The apparatus of claim 10, wherein the at least one detector is spaced a distance apart from the light source, and wherein the distance is such that the sensed emitted light travels substantially exclusively through the organ tissue.

16. The apparatus of claim 10, wherein the at least one detector includes a first detector spaced a first distance apart from the light source, and a second detector spaced a second distance from the light source, which second distance is greater than the first distance, and wherein the first and second distances are such that the sensed emitted light travels substantially exclusively through the organ tissue.