METHOD FOR SPECTROPHOTOMETRIC BLOOD OXYGENATION MONITORING OF THE LOWER GASTROINTESTINAL TRACT

• US 20120136225A1
• Filed: 07/12/2010
• Published: 05/31/2012
• Est. Priority Date: 07/10/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cas Medical Systems Incorporated (Edwards Lifesciences Corporation)
• Inventors: Benni, Paul B., Kopotic, Robert J.
• Granted Patent: US 9,693,717 B2
• Time in Patent Office: Days
• US Class Current: 600/323
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/4255 Intestines, colon or appendix
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence

Abstract

A method and apparatus for non-invasively determining a blood oxygen saturation level and/or the presence of fecal matter within a subject'"'"'s lower GI tissue is provided. The method includes the steps of: a) providing a spectrophotometric sensor operable to transmit light into the subject'"'"'s tissue, and to sense the light; b) sensing the subject'"'"'s lower GI Tissue Using the Sensor, and Producing signal data from sensing the subject'"'"'s tissue; c) processing the signal data, including determining the presence of one or more wavelength dependent light absorbing materials not present within blood within the subject'"'"'s lower GI tract from the signal data; and d) determining the blood oxygen saturation level and/or presence of fecal matter within the subject'"'"'s lower GI tissue, including accounting for the presence of the wavelength dependent light absorbing material not present within blood within the subject'"'"'s lower GI tract determined using the signal data.

Claims

1. A method for non-invasively determining a blood oxygen saturation level within a subject'"'"'s lower GI 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 lower GI tissue using the sensor, and producing signal data from sensing the subject'"'"'s tissue;

processing the signal data, including determining the presence of one or more wavelength dependent light absorbing materials not present in blood within the subject'"'"'s lower GI tract from the signal data; and

determining the blood oxygen saturation level within the subject'"'"'s lower GI tissue by using the signal data, including accounting for the presence of the wavelength dependent light absorbing material not present in blood within the subject'"'"'s lower GI tract.

2. The method of claim 1, wherein the wavelength dependent light absorbing material includes one or more of meconium, transitional stool, biliverdin, and nutritional food.

3. The method of claim 1, wherein within the step of determining the blood oxygen saturation level within the subject'"'"'s lower GI tissue includes not determining the blood oxygen saturation level within the subject'"'"'s lower GI tissue until the presence of at least one wavelength dependent light absorbing material is below a predetermined value.

4. The method of claim 3, wherein the wavelength dependent light absorbing material includes one or more of meconium, transitional stool, bilverdin, and nutritional food.

5. The method of claim 1, wherein the step of determining the blood oxygen saturation level within the subject'"'"'s lower GI tissue includes creating one or more corrective factors for one or both Hb and HbO2 based on the presence of at least one wavelength dependent light absorbing materials.

6. The method of claim 5, wherein the wavelength dependent light absorbing material includes one or more of meconium, transitional stool, bilverdin, and nutritional food.

7. A method for non-invasively determining the presence of fecal matter within the lower GI tract of a subject, comprising the steps of:

providing a spectrophotometric sensor operable to transmit light at a plurality of wavelengths into the subject'"'"'s tissue, and to sense the light;

sensing the subject'"'"'s lower GI tissue using the sensor, and producing signal data from sensing the subject'"'"'s tissue; and

processing the signal data, including determining the presence of fecal matter within the subject'"'"'s lower GI tract based on the presence of one or more of meconium, transitional stool, biliverdin, and nutritional food within the subject'"'"'s lower GI tract, wherein the presence of meconium and nutritional fluid is determined using a difference in attenuation between the wavelengths.

8. An near-infrared spectroscopy apparatus for non-invasively determining a blood oxygen saturation level within a subject'"'"'s lower GI tissue, comprising:

a spectrophotometric sensor having at least one light source and at least one light detector, which sensor is operable to transmit light into a subject'"'"'s tissue, to sense the transmitted light, and to produce signal data from the sensed light; and

a processor adapted to receive and process the signal data to determine the presence of a wavelength dependent light absorbing material not present within blood within the subject'"'"'s lower GI tract.

9. The apparatus of claim 8, wherein the processor is further adapted to determine a blood oxygen saturation level within the subject'"'"'s lower GI tissue, using the signal data.

10. The apparatus of claim 8, wherein the processor is adapted to account for the presence of at least one or more of meconium, transitional stool, biliverdin, and nutritional food within the GI tract of the subject.

11. An apparatus for non-invasively determining the presence of fecal matter within a lower GI tract of a subject, comprising:

a spectrophotometric sensor having at least one light source and at least one light detector, which sensor is operable to transmit light at a plurality of wavelengths into the subject'"'"'s tissue, and to sense the light;

a processor adapted to receive the signal data and to process the signal data to determine the presence of fecal matter within the lower GI tract of the subject, which processing includes determining the presence of a wavelength dependent light absorbing material found within fecal matter.

12. The apparatus of claim 11, wherein the processor is adapted to account for the presence of at least one or more of meconium, transitional stool, biliverdin, and nutritional food in fecal matter within the GI tract of the subject.