Method for spectrophotometric blood oxygenation monitoring of the lower gastrointestinal tract

• US 9,693,717 B2
• Filed: 07/12/2010
• Issued: 07/04/2017
• Est. Priority Date: 07/10/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cas Medical Systems Incorporated (Edwards Lifesciences Corporation)
• Inventors: Kopotic, Robert J., Benni, Paul B.
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan (JJ)
• Application Number:
  US13/383,391
• Publication Number:
  US 20120136225A1
• Time in Patent Office: 2,549 Days
• Field of Search: 600309, 600310, 600322, 600323, 600338, 600340, 600473, 600476, 600336, 356 41
• 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 gastrointestinal (GI) tissue, which tissue defines a lower GI tract of the subject, comprising:

non-invasively sensing the subject'"'"'s lower GI tissue using a spectrophotometric sensor having at least one light source and at least one light detector, which sensing includes transmitting light from the light source into the subject'"'"'s lower GI tissue and GI tract at a plurality of wavelengths in a range of about 600 nm to about 900 nm at an initial intensity, and sensing the transmitted light after passage of the transmitted light through the subject'"'"'s lower GI tissue and lower GI tract using the at least one light detector, and producing signal data representative of a detected intensity of the sensed light;

using at least one processor to determine;

an attenuation between the initial intensity and the detected intensity of one or more wavelengths of the plurality of wavelengths of light;

an index value that accounts for the presence of one or more wavelength dependent light absorbing materials disposed within the subject'"'"'s lower GI tract, which absorbing materials are not present in the subject'"'"'s blood, based on the determined attenuation;

at least one corrective factor value based on the index value when the index value is above a predetermined value; and

the blood oxygen saturation level within the subject'"'"'s lower GI tissue, which blood oxygen saturation level determination includes using the at least one corrective factor value when the at least one corrective factor value is determined.

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

3. The method of claim 2, wherein the at least one corrective factor value includes a deoxyhemoglobin (Hb) corrective factor value and an oxyhemoglobin (HbO2) corrective factor value.

4. The method of claim 2, wherein the at least one corrective factor value varies as a function of the determined attenuation of the one or more wavelengths of the plurality of wavelengths of light, which one or more wavelengths includes at least one wavelength in a red spectrum of visible light.

5. The method of claim 4, wherein the red spectrum of light is between about 600 nm to about 780 nm.

6. The method of claim 5, wherein the at least one wavelength in the red spectrum of light is about 690 nm.

7. A near-infrared spectroscopy apparatus for non-invasively determining a blood oxygen saturation level within a subject'"'"'s lower gastrointestinal (GI) tissue, which tissue defines a lower GI tract of the subject, comprising:

a non-invasive spectrophotometric sensor having at least one light source that selectively transmits light at a plurality of wavelengths in a range of about 600 nm to about 900 nm at an initial intensity value, and at least one light detector configured to sense the light transmitted from the at least one light source after such light has passed through the subject'"'"'s lower GI tissue and lower GI tract, which the at least one light detector produces signal data representative of a detected intensity of the sensed light; and

a processor programmed within a non-transitory memory to control the sensor and to receive the signal data, and to determine;

an attenuation between the initial intensity and the detected intensity of one or more wavelengths of the plurality of wavelengths of light;

an index value that accounts for the presence of one or more wavelength dependent light absorbing materials disposed within the subject'"'"'s lower GI tract, which absorbing materials are not present in the subject'"'"'s blood, based on the determined attenuation;

at least one corrective factor value based on the index value when the index value is above a predetermined value; and

the blood oxygen saturation level within the subject'"'"'s lower GI tissue, which blood oxygen saturation level determination includes using the at least one corrective factor value when the at least one corrective factor value is determined.

8. The apparatus of claim 7, wherein the one or more wavelength dependent absorbing material includes at least one of meconium, transitional stool, biliverdin, or nutritional fluid.

9. The apparatus of claim 8, wherein the plurality of wavelengths includes one or more wavelengths having an absorbance value magnitude for the one or more wavelength dependent light absorbing materials that is different from an absorbance value magnitude for oxyhemoglobin (HbO₂) or an absorbance value magnitude for deoxyhemoglobin (Rb) at the same one or more wavelengths.

10. The apparatus of claim 8, wherein the at least one corrective factor value includes a deoxyhemoglobin (Hb) corrective factor value and an oxyhemoglobin (HbO₂) corrective factor value.

11. The apparatus of claim 8, wherein the at least one corrective factor value varies as a function of the determined attenuation of the one or more wavelengths of the plurality of wavelengths of light, which one or more wavelengths includes at least one wavelength in a red spectrum of visible light.

12. The apparatus of claim 11, wherein the red spectrum of light is between about 600 nm to about 780 nm.

13. The apparatus of claim 11, wherein the at least one wavelength in the red spectrum of light is about 690 nm.