WO2006124455B1 - Improved method for spectrophotometric blood oxygenation monitoring - Google Patents

Improved method for spectrophotometric blood oxygenation monitoring

Info

Publication number
WO2006124455B1
WO2006124455B1 PCT/US2006/018082 US2006018082W WO2006124455B1 WO 2006124455 B1 WO2006124455 B1 WO 2006124455B1 US 2006018082 W US2006018082 W US 2006018082W WO 2006124455 B1 WO2006124455 B1 WO 2006124455B1
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
subject
light
signal data
sensor
Prior art date
Application number
PCT/US2006/018082
Other languages
French (fr)
Other versions
WO2006124455A1 (en
Inventor
Paul B Benni
Original Assignee
Cas Medical Systems Inc
Paul B Benni
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US11/914,074 priority Critical patent/US8396526B2/en
Priority to AU2006247746A priority patent/AU2006247746B2/en
Priority to CA2608426A priority patent/CA2608426C/en
Priority to EP13197260.6A priority patent/EP2708180B1/en
Priority to JP2008511319A priority patent/JP5175179B2/en
Priority to EP06770173.0A priority patent/EP1885235B1/en
Application filed by Cas Medical Systems Inc, Paul B Benni filed Critical Cas Medical Systems Inc
Publication of WO2006124455A1 publication Critical patent/WO2006124455A1/en
Publication of WO2006124455B1 publication Critical patent/WO2006124455B1/en
Priority to AU2010227077A priority patent/AU2010227077B2/en
Priority to US13/793,964 priority patent/US8923943B2/en
Priority to US14/549,135 priority patent/US9456773B2/en
Priority to US15/283,883 priority patent/US10117610B2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14553—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases specially adapted for cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026—Measuring blood flow
    • A61B5/0261—Measuring blood flow using optical means, e.g. infrared light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14552—Details of sensors specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1495—Calibrating or testing of in-vivo probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6814—Head
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N21/359—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light using near infrared light
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47—Scattering, i.e. diffuse reflection
    • G01N21/49—Scattering, i.e. diffuse reflection within a body or fluid
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/314—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths
    • G01N2021/3144—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths for oxymetry

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

AMENDED CLAIMS received by the International Bureau on 24 November 2006 (24.11.06)
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 signal data from the light sensed; processing the signal data, including the steps of cancelling out wavelength independent background light absorption and scattering from a difference in attenuation between select wavelengths, and accounting for wavelength dependent optical characteristics of the subject's tissue using the signal data; and determining the blood oxygen saturation level within the subject's tissue compensating for wavelength dependent physical characteristics of 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 step includes the use of absorption coefficients for pigmentation in the subject's tissue.
4- The method of claim 3, wherein the processing determines 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.
S. 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:
20 sensing the subject's tissue using the sensor, and producing signal data there from, which signal data is attributable to non-pulsatile blood flow within the microcirculation of the subject's tissue; processing the signal data, including the steps of cancelling out wavelength independent background light absorption and scattering from a difference in attenuation between select wavelengths, and accounting for wavelength dependent optical characteristics of the subject's tissue using the signal data; and determining the blood oxygen saturation level within the subject's tissue compensating for wavelength dependent physical characteristics of the subject's tissue.
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 processing step includes the use of absorption coefficients for pigmentation in the subject's tissue,
8. A method for non-invasively determining a blood oxygen saturation level of the microcirculation within a subject's tissue using a spectrophotometric sensor, said method comprising the steps of: transmitting light into the subject's tissue using the sensor; sensing the light using the sensor, wherein the light is sensed along a plurality of selectively chosen wavelengths, after the light travels through the subject's tissue, and producing signal data from sensing the subject's tissue; processing the signal data, including the steps of cancelling out wavelength independent background light absorption and scattering from the difference in attenuation between select wavelengths, accounting for wavelength dependent optical characteristics of the particular subject's tissue, and creating one or more calibration constants to account for the subject's wavelength dependent tissue optical properties; and determining the blood oxygen saturation level within the subject's tissue using a difference in attenuation using a subset of the chosen plurality of wavelengths and the calibration constants.
9. The method of claim 8, wherein the step of determining the blood oxygen saturation level within the subject's tissue comprises processing signal data other than that used to create the one or more calibration constants.
10. The method of claim 9, 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.
I L The method of claim 10, wherein the processing step includes the use of absorption coefficients for pigmentation in the subject's tissue.
12. 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.
13. The method of claim 8, wherein the processing step includes the use of absorption coefficients for pigmentation in the subject's tissue.
14. A method for calibrating a NIRS sensor, comprising the steps of: transmitting light into a subject's tissue using the sensor; sensing the light using the sensor, along a plurality of selectively chosen wavelengths after the light travels through the subject's tissue, and producing signal data from sensing the subject's tissue; and calibrating the sensor using the signal data.
15. The method of claim 14, wherein the calibrating step includes processing the signal data to consider pigmentation of the subject's tissue.
16. The method of claim 15, wherein the processing step includes the use of absorption coefficients for pigmentation in the subject's tissue,
22
17. A method for non~invasively determining a blood oxygen saturation 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 signal data from the sensing, which signal data is attributable to non-pulsatile blood flow within the microcirculation of the subject's tissue; and processing the signal data, including the steps of cancelling out wavelength independent background light absorption and scattering from a difference in attenuation between select wavelengths, accounting for wavelength dependent optical characteristics of the particular subject's tissue, and determining the concentration of oxyhemoglobin, deoxyhemoglobin of the micro vasculature, and the blood oxygen saturation level of the microvasculature within the subject's tissue.
18. The method of claim 17, wherein the step of processing the signal data comprises initially determining the concentration of oxyhemoglobin, deoxyhemoglobin, and pigmentation within the subject's tissue, and subsequently determining the blood oxygen saturation level within the subject's tissue using the determined concentrations of oxyhemoglobin and deoxyhemoglobin.
i 9. The method of claim 18, wherein the step of processing the signal data comprises using the determined pigmentation concentration to calibrate the sensor,
20. The method of claim 19, wherein the processing step includes the use of absorption coefficients for pigmentation in the subject's tissue.
23
21. A method for non-invasively determining a blood oxygen saturation level within a subject's tissue, comprising the steps of: providing a spectrophotometric sensor operable to transmit light within a predetermined range of wavelengths into the subject's tissue, and to sense a plurality of preselected wavelengths of the light disposed within the range; sensing the subject's tissue using the sensor, and producing signal data from sensing the subject's tissue; and processing the signal data, including determining light attenuation for one or more components of the subject's tissue, other than oxyhemoglobin and deoxyhemoglobin, which components have a tissue optical property that varies over the range of wavelengths, to determine the blood oxygenation level within the subject's tissue,
Cancel claim 22.
23 , 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 operabJy connected to the at least one sensor, the processor having an algorithm operable to process the signal data to account for the physical characteristics of the subject's tissue.
24, The apparatus of claim 23, wherein the physical characteristics of the subject's tissue comprise pigmentation.
25, The apparatus of claim 24, wherein the algorithm utilizes absorption coefficients for pigmentation in the subject's tissue.
24
26. The apparatus of claim 25, 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.
27. The apparatus of claim 26, 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.
28. A method for non-invasi vely determining a blood oxygen saturation 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 non-pulsatile light passed through microcirculation within the subject's tissue using the sensor, and producing signal data from the sensed non-pulsatile light; processing the signal data, including the steps of: cancelling out wavelength independent background light absorption and scattering from a difference in attenuation between select wavelengths, accounting for wavelength dependent optical characteristics of the particular subject's tissue being sensed within the sensor, creating one or more calibration constants to account for the subject's wavelength dependent tissue optical properties, and determining the concentration of oxyhemoglobin and deoxyhemoglobin of the microvasculature and the blood oxygen saturation level within the subject's tissue using a difference in attenuation using a subset of said chosen plurality of wavelengths and said calibration constants.
25
PCT/US2006/018082 2005-05-12 2006-05-10 Improved method for spectrophotometric blood oxygenation monitoring WO2006124455A1 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
AU2006247746A AU2006247746B2 (en) 2005-05-12 2006-05-10 Improved method for spectrophotometric blood oxygenation monitoring
CA2608426A CA2608426C (en) 2005-05-12 2006-05-10 Improved method for spectrophotometric blood oxygenation monitoring
EP13197260.6A EP2708180B1 (en) 2005-05-12 2006-05-10 Improved method for spectrophotometric blood oxygenation monitoring
JP2008511319A JP5175179B2 (en) 2005-05-12 2006-05-10 Improved blood oxygenation monitoring method by spectrophotometry
EP06770173.0A EP1885235B1 (en) 2005-05-12 2006-05-10 Improved method for spectrophotometric blood oxygenation monitoring
US11/914,074 US8396526B2 (en) 2005-05-12 2006-05-10 Method for spectrophotometric blood oxygenation monitoring
AU2010227077A AU2010227077B2 (en) 2005-05-12 2010-10-08 Improved method for spectrophotometric blood oxygenation monitoring
US13/793,964 US8923943B2 (en) 2005-05-12 2013-03-11 Method for spectrophotometric blood oxygenation monitoring
US14/549,135 US9456773B2 (en) 2005-05-12 2014-11-20 Method for spectrophotometric blood oxygenation monitoring
US15/283,883 US10117610B2 (en) 2005-05-12 2016-10-03 Method for spectrophotometric blood oxygenation monitoring

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US68019205P 2005-05-12 2005-05-12
US60/680,192 2005-05-12

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US11/914,074 A-371-Of-International US8396526B2 (en) 2005-05-12 2006-05-10 Method for spectrophotometric blood oxygenation monitoring
US13/793,964 Continuation US8923943B2 (en) 2005-05-12 2013-03-11 Method for spectrophotometric blood oxygenation monitoring

Publications (2)

Publication Number Publication Date
WO2006124455A1 WO2006124455A1 (en) 2006-11-23
WO2006124455B1 true WO2006124455B1 (en) 2007-01-11

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PCT/US2006/018082 WO2006124455A1 (en) 2005-05-12 2006-05-10 Improved method for spectrophotometric blood oxygenation monitoring

Country Status (6)

Country Link
US (4) US8396526B2 (en)
EP (2) EP1885235B1 (en)
JP (1) JP5175179B2 (en)
AU (2) AU2006247746B2 (en)
CA (1) CA2608426C (en)
WO (1) WO2006124455A1 (en)

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