Reliable noninvasive measurement of blood gases
First Claim
1. A method of determining non-invasively and in vivo at least two blood gas parameters in a human, said method comprising steps of:
- a. generating light at three or more different wavelengths, said wavelengths being in the range of 500 nm to 2500 nm;
b. irradiating in vivo and non-invasively blood containing tissue with said wavelengths, so that there is differential attenuation of at least some intensities of said wavelengths, said wavelength dependent differential attenuation being a function of said blood containing tissue and the direct and indirect spectral influences resulting from the unknown values of pH, HCO3-, PCO2, PO2 and O2 saturation in said blood containing tissue;
c. measuring said intensities of said wavelengths emerging from said blood containing tissue to obtain a set of at least three spectral intensities v. wavelengths; and
d. determining said unknown values of at least two of pH, HCO3-, PCO2, and a measure of oxygen concentration in said blood containing tissue from said intensities emerging from said blood containing tissue, said values being within the physiological ranges observed in blood containing tissue.
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Accused Products
Abstract
Methods and apparatus for, preferably, determining noninvasively and in vivo at least two of the five blood gas parameters (i.e., pH, PCO2, [HCO3- ], PO2, and O2 sat.) in a human. The non-invasive method includes the steps of: generating light at three or more different wavelengths in the range of 500 nm to 2500 nm; irradiating blood containing tissue; measuring the intensities of the wavelengths emerging from the blood containing tissue to obtain a set of at least three spectral intensities v. wavelengths; and determining the unknown values of at least two of pH, [HCO3- ], PCO2 and a measure of oxygen concentration. The determined values are within the physiological ranges observed in blood containing tissue. The method also includes the steps of providing calibration samples, determining if the spectral intensities v. wavelengths from the tissue represents an outlier, and determining if any of the calibration samples represents an outlier. The determination of the unknown values is performed by at least one multivariate algorithm using two or more variables and at least one calibration model. Preferably, there is a separate calibration for each blood gas parameter being determined. The method can be utilized in a pulse mode and can also be used invasively. The apparatus includes a tissue positioning device, a source, at least one detector, electronics, a microprocessor, memory, and apparatus for indicating the determined values.
550 Citations
62 Claims
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1. A method of determining non-invasively and in vivo at least two blood gas parameters in a human, said method comprising steps of:
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a. generating light at three or more different wavelengths, said wavelengths being in the range of 500 nm to 2500 nm; b. irradiating in vivo and non-invasively blood containing tissue with said wavelengths, so that there is differential attenuation of at least some intensities of said wavelengths, said wavelength dependent differential attenuation being a function of said blood containing tissue and the direct and indirect spectral influences resulting from the unknown values of pH, HCO3-, PCO2, PO2 and O2 saturation in said blood containing tissue; c. measuring said intensities of said wavelengths emerging from said blood containing tissue to obtain a set of at least three spectral intensities v. wavelengths; and d. determining said unknown values of at least two of pH, HCO3-, PCO2, and a measure of oxygen concentration in said blood containing tissue from said intensities emerging from said blood containing tissue, said values being within the physiological ranges observed in blood containing tissue. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A method of determining invasively and in vivo at least two blood gas parameters in human blood, said method comprising steps of:
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a. generating light at three or more different wavelengths, said wavelengths being in the visible and infrared region; b. irradiating blood with said wavelengths, so that there is differential attenuation of at least some intensities of said wavelengths, said wavelength dependent differential attenuation being a function of the direct and indirect influences resulting from the unknown values of pH, HCO3-, PCO2, PO2 and O2 sat. in said blood; c. measuring said intensities of said wavelengths from said blood to obtain a set of at least three spectral intensities v. wavelengths; and d. determining said values of at least two of pH, HCO3-, PCO2, and a measure of oxygen concentration in said blood from said intensities emerging from said blood, said values being within the ranges observed in blood. - View Dependent Claims (22, 23, 24, 25, 26)
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27. A method of determining non-invasively and in vivo at least one of pH, HCO3-, and PCO2 in a human, said method comprising steps of:
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a. generating light at two or more different wavelengths, said wavelengths being in the range of 500 nm to 2500 nm; b. irradiating in vivo and non-invasively blood containing tissue with said wavelengths so that there is differential attenuation of at least some intensities of said wavelengths, said wavelength dependent differential attenuation being a function of said blood containing tissue and the unknown values of pH, HCO3- and PCO2 in said blood containing tissue; c. measuring said intensities of said wavelengths emerging from said blood containing tissue to obtain a set of at least two spectral intensities v. wavelengths; d. generating at least one calibration model, said model being a function of conventionally measured values of at least one of pH, HCO3- and PCO2, obtained from calibration samples and spectral intensities v. wavelengths obtained from irradiating said calibration samples with two or more different wavelengths of light, said wavelengths being in the range of 500 nm to 2500 nm; and e. determining said value of at least one of pH, HCO3- and PCO2 from said intensities emerging from said blood containing tissue utilizing at least one algorithm and said at least one calibration model. - View Dependent Claims (28, 29, 30)
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31. A method of determining non-invasively and in vivo two or more blood gas parameters in arterial blood in a human, said method comprising steps of:
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a. generating light at three or more different wavelengths, said wavelengths being in the range of 500 nm to 2500 nm; b. irradiating in vivo and non-invasively blood containing tissue with said wavelengths, so that there is differential attenuation of at least some intensities of said wavelengths, said wavelength dependent differential attenuation being a function of said blood containing tissue and the direct and indirect spectral influences resulting from the unknown values of pH, HCO3-, PCO2, PO2 and O2 sat. in said arterial blood; c. measuring said intensities of said wavelengths emerging from said blood containing tissue during the diastolic portion of the cardiac cycle of said human to obtain a diastolic set of at least three spectral intensities v. wavelengths; d. measuring said intensities of said wavelengths emerging from said blood containing tissue during the systolic portion of said cardiac cycle to obtain a systolic set of at least three spectral intensities v. wavelengths; e. determining the measure of change between said diastolic and systolic sets of spectral intensities v. wavelengths; and f. determining said unknown values of at least two of pH, HCO3-, PCO2, and a measure of oxygen concentration in said arterial blood from said measure of change between said diastolic and systolic sets of spectral intensities v. wavelengths, said values being within the ranges observed in arterial blood. - View Dependent Claims (32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48)
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49. A quantitative analysis instrument for noninvasive measurement of blood gas parameters present in blood containing tissue in a human, said instrument comprising:
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a. a device for positioning said blood containing tissue; b. a source of at least three different wavelengths of light positioned relative to said tissue positioning device, to direct light into said blood containing tissue, said wavelengths being in the range of 500 to 2500 nm; c. at least one detector positioned relative to said tissue positioning device for measuring the spectral intensities of at least a portion of said light emerging from said blood containing tissue at, at least, three wavelengths of said light; d. electronics, a microprocessor and memory means for processing said measured spectral intensities to determine at least two of pH, PCO2, HCO3-, and a measure of oxygen saturation at values within the physiological ranges observed in said blood containing tissue; and e. means for indicating said determined values of said blood gas parameters. - View Dependent Claims (50, 51)
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52. A quantitative analysis instrument for noninvasive measurement of blood gas parameters present in blood containing tissue in a human, said instrument comprising:
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a. a device for positioning said blood containing tissue; b. a source of at least three different wavelengths of light positioned relative to said tissue positioning device to direct light into said blood containing tissue, said wavelengths being in the range of 500 to 2500 nm; c. at least one detector positioned relative to said tissue positioning device for measuring the spectral intensities of at least a portion of said light emerging from said blood containing tissue at, at least, three wavelengths of said light; d. electronics, a microprocessor and memory means including a multivariate algorithm and a calibration model for processing said measured spectral intensities to determine at least two of pH, PCO2, HCO3-, and a measure of oxygen saturation at values within the physiological ranges observed in said blood containing tissue, said algorithm using at least two variables, said model being a function of conventionally measured blood gas parameters obtained from calibration samples and a set of spectral intensities v. wavelengths obtained from irradiating said calibration samples with at least three wavelengths of light in the range of 500-2500 nm; and e. means for indicating said determined values of said blood gas parameters. - View Dependent Claims (53)
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54. A quantitative analysis instrument for noninvasive measurement of blood gas parameters present in blood containing tissue of a human, said instrument comprising:
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a. a device for positioning said blood containing tissue; b. a source of at least three different wavelengths of light positioned relative to said tissue positioning device, to direct light into said blood containing tissue, said wavelengths being in the range of 500 to 2500 nm; c. at least one detector positioned relative to said tissue positioning device for measuring the spectral intensities of at least a portion of said light emerging from said blood containing tissue at, at least, three wavelengths of said light; d. electronics, a microprocessor and memory means including a multivariate algorithm and a calibration model for processing said measured spectral intensities to determine at least two of pH, PCO2, HCO3-, and a measure of oxygen saturation at values being within the physiological ranges observed in said blood containing tissue, said algorithm using at least two variables, said algorithm being capable of utilizing more discrete spectral intensities per sample than the number of calibration samples used to generate said model, said model being a function of conventionally measured blood gas parameters obtained from said calibration samples and a set of spectral intensities v. wavelengths obtained from irradiating said calibration samples with at least three wavelengths of light in the range of 500-2500 nm; and e. means for indicating said determined values of said blood gas parameters.
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55. A quantitative analysis instrument for noninvasive measurement of two or more blood gas parameters present in blood containing tissue of a human, said instrument comprising:
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a. a device for positioning said blood containing tissue; b. a source of at least three different wavelengths of light positioned relative to said tissue positioning device, to direct light into said blood containing tissue, said wavelengths being in the range of 500 to 2500 nm; c. at least one detector positioned relative to said tissue positioning device for measuring the spectral intensities of at least three wavelengths of said light emerging from said blood containing tissue during the diastolic portion of the cardiac cycle of said human, to obtain a diastolic set of spectral intensities v. wavelengths, and for measuring the spectral intensities of at least three wavelengths of said light emerging from said blood containing tissue during the systolic portion of the cardiac cycle of said human, to obtain a systolic set of spectral intensities v. wavelengths; d. memory means for storing said diastolic set of spectral intensities v. wavelengths and said systolic set of spectral intensities v. wavelengths; e. electronics, a microprocessor and said memory means for processing said diastolic and systolic sets of spectral intensities to determine a measure of change between said diastolic and systolic sets, to obtain a blood specific set of spectral intensities v. wavelengths, said memory means including a multivariate algorithm and a multivariate calibration model, said electronics, said microprocessor and said memory means processing said blood specific set of spectral intensities v. wavelengths to determine at least two of pH, PCO2, HCO3-, and a measure of oxygen saturation at values within the physiological ranges observed in said blood, said algorithm using at least two variables, said model being a function of conventionally measured blood gas parameters obtained from calibration samples and a set of spectral intensities v. wavelengths obtained from irradiating said calibration samples with at least three wavelengths of light in the range of 500-2500 nm; and f. means for indicating said determined values of said blood gas parameters. - View Dependent Claims (56, 57, 58, 59, 60)
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61. A quantitative analysis instrument for invasive and in vivo measurement of blood gas parameters present in blood in human, said instrument comprising:
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a. a source of at least three different wavelengths of light optically coupled to said blood to direct light into said blood, said wavelengths being in the visible, near infrared, and infrared regions of the spectrum; b. at least one detector optically coupled to said blood for measuring the spectral intensities of at least a portion of said light emerging from said blood at, at least, three wavelengths of light; c. electronics, a microprocessor and memory means for processing said spectral intensities to determine at least two of pH, PCO2, HCO3-, and a measure of oxygen saturation at values being within the physiological ranges observed in said blood; and d. means for indicating said determined values of said blood gas parameters.
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62. A quantitative analysis instrument for invasive and in vivo measurement of blood gas parameters present in blood in a human, comprising:
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a. a source of at least three different wavelengths of light optically coupled to said blood to direct light into said blood, said wavelengths being in the visible, near infrared, and infrared regions of the spectrum; b. at least one detector optically coupled to said blood for measuring the spectral intensities of at least a portion of said light emerging from said blood at, at least, three wavelengths of light; c. electronics, a microprocessor and memory means, said memory means including a multivariate algorithm and a multivariate calibration model, for processing said spectral intensities to determine at least two of pH, PCO2, HCO3-, and a measure of oxygen saturation at values within the physiological ranges observed in said blood, said algorithm using at least two variables, said algorithm being capable of utilizing more discrete spectral intensities per sample than the number of calibration samples used to generate said model, said model being a function of conventionally measured blood gas parameters obtained from said calibration samples and a set of spectral intensities v. wavelengths obtained from irradiating said calibration samples with at least three wavelengths of light in the visible, near infrared, and infrared regions of the spectrum; and d. means for indicating said determined values of said blood gas parameters.
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Specification