Method of and apparatus for recognizing falsified pulse oximetry measurements

Claim 2

Method of detecting falsified pulse oximetry measurements in which light of at least two wavelengths alternately irradiates tissue of a patient and an excitation light source is arranged to cause light transmitted through or reflected from the tissue to be measured with a photoreceptor, filtered, converted via A/D conversion and subsequently analyzed to determine the oxygen saturation in the patient's blood, comprising modifying the intensity of the light of the excitation light source during repeated sequential time intervals, measuring with the photoreceptor the intensity of a modified signal during the repeated time intervals which in comparison to the signal measured with unmodified excitation light source(s) has a modified useful signal component and a constant ambient light component, filtering and converting the modified signal to derive a converted modified signal by A/D-conversion in essentially the same way as the signal measured with an unmodified excitation light source is filtered and converted, deriving from the converted modified signal a value representative of the amplitude of the ambient light component, the value representative of the amplitude of the ambient light component, or a quantity derived from the value, being a measure of the signal quality.

Claim 3

Method according to claim 1, further including setting to zero, during repeated time intervals, the intensity of the light emitted by the source.

Claim 4

Method according to claim 1, wherein the quantity used as a measure of the signal quality is calculated as a useful-to-noise-signal ratio in which a value representative of the amplitude of a digitized measurement signal is set in relationship to the value representative of the amplitude of the ambient light component, or is calculated as a signal-to-noise ratio in a logarithmic form of the useful-to-noise-signal ratio.

Claim 5

Method according to claim 3, wherein the values representative of the amplitudes of the measurement signal or the ambient light component are calculated as effective values or mean values, or as peak amplitudes.

Claim 6

Method according to claim 1, wherein the quantity used as a measure of the signal quality is the amplitude of the ambient light component.

Claim 7

Method according to claim 1, wherein the quantity used as a measure of the signal quality is the difference between the amplitude of the ambient light component and the amplitude of a value representative of a digitized measurement signal resulting from the A/D conversion.

Claim 8

Method according to claim 1, wherein the measure representing signal quality is derived in response to only an alternative component of the ambient light component.

Claim 9

Method according to claim 1 further including visually displaying the quantity used as a measure of the signal quality.

Claim 10

Method according to claim 1 further including comparing the quantity used as a measure of the signal quality with at least one threshold value, and rejecting the measurement or generating an alarm in response to the quantity used as a measure of the signal quality having a predetermined relation relative to the threshold.

Claim 11

Method according to claim 1, further including high pass filtering both the signals measured with an unmodified excitation light source and the signals measured with the modified excitation light.

Claim 12

Method according to claim 10, further including rectifying and high pass filtering both the signals measured with the unmodified excitation light source and the modified signals measured with modified excitation light source.

Claim 13

Method according to claim 1, further including multiplexing the output signal of the photoreceptor and distributing each measurement at least one processing channel, and supplying the ambient light signal to a separate processing channel, which is essentially identical to the processing channels assigned to the measurement signals.

Claim 14

Method according to claim 1 further including periodically interrupting the recording and the processing of measurement signals and recording and processing the resulting interrupted ambient light signals.

Claim 15

Method of claim 1, further including recording dark values during a time interval while the excitation light source is switched off and only ambient light is incident on the photoreceptor, and subsequently deducting the dark values from both the measurement signals and the ambient light signal.

Claim 16

Method according to claim 14, wherein the time intervals during which the dark values are recorded and during which the ambient light signal is recorded follow each other directly in any order.

Claim 17

Pulse oximeter for measuring the oxygen saturation of a patient, comprising at least one excitation light source for irradiating tissue of the patient with light of at least two wavelengths; at least one photoreceptor for measuring the light from said source as transmitted through or reflected by the tissue; measurement signal processing channels for the measurement signals received by the photoreceptor, each measurement signal processing channel comprising filters and an analog-digital converter for filtering and A/D-conversion of the measurement signals in substantially the same ways; and a processing unit for calculating the patient oxygen saturation from the measurement signals which have been filtered and converted by A/D-conversion; and an ambient light processing channel including filters and an analog-digital-converter having substantially the same characteristic as the filters and analog-digital-converters of measurement signal processing channels, the ambient light processing channel being only activated during time intervals while the intensity of the excitation light source is switched off or modulated.

Claim 18

Pulse oximeter for measuring the oxygen saturation of a patient, comprising at least one excitation light source for irradiating tissue of the patient with light of at least two wavelengths; at least one photoreceptor for measuring the light from said source as transmitted through or reflected by the tissue; measurement signal processing channels for the measurement signals received by the photoreceptor, each measurement signal processing channel comprising filters and an analog-digital converter for filtering and A/D-conversion of the measurement signals in substantially the same ways; and a processing unit for calculating the patient oxygen saturation from the measurement signals which have been filtered and converted by A/D-conversion; and an ambient light processing channel including filters and an analog-digital-converter having substantially the same characteristic as the filters and analog-digital-converters of measurement signal processing channels, the ambient light processing channel being only activated during time intervals while the intensity of the excitation light source is switched off or modulated.

Claim 19

Pulse oximeter according to claim 16, further including a dark value processing channel activated only during time intervals while the excitation light source is switched off, and circuitry for deducting the dark value from the measurement signals and the ambient light signal.

Claim 20

Pulse oximeter for measuring the oxygen saturation of a patient comprising an excitation circuit for at least two excitation wavelengths of differing wavelengths; a receiver circuit for receiving signals from a photoreceptor; plural measurement signal processing channels for the measurement signals received by the receiver circuit, each measurement signal processing channel comprising a filter and analog-digital-converter for filtering and A/D-conversion of these measurement signals; and a processing unit for calculating the oxygen saturation from the measurement signals which have been filtered and converted by A/D-conversion; and an ambient light processing channel which is only activated in time intervals while the intensity of the excitation circuit is in a condition causing only background optical energy or modulated optical energy to be incident on the photoreceptor, the ambient processing channel including filters and analog-digital-converters for processing a signal received from the photoreceptor in the same manner as the measurement signal processing channels.

Claim 21

Pulse oximeter for measuring the oxygen saturation of a patient comprising an excitation circuit for at least two excitation wavelengths of differing wavelengths; a receiver circuit for receiving signals from a photoreceptor; plural measurement signal processing channels for the measurement signals received by the receiver circuit, each measurement signal processing channel comprising a filter and analog-digital-converter for filtering and A/D-conversion of these measurement signals; and a processing unit for calculating the oxygen saturation from the measurement signals which have been filtered and converted by A/D-conversion; and an ambient light processing channel which is only activated in time intervals while the intensity of the excitation circuit is in a condition causing only background optical energy or modulated optical energy to be incident on the photoreceptor, the ambient processing channel including filters and analog-digital-converters for processing a signal received from the photoreceptor in the same manner as the measurement signal processing channels.

Claim 22

Pulse oximeter according to claim 18, wherein the ambient light processing channel processes to derive at least one measurement signal and one ambient light signal, the ambient light processing channel including a computation unit responsive to the at least one measurement signal and one ambient light signal for calculating values representative of the amplitudes of the digitized measurement signal and the digitized ambient light signal and for calculating the ratio between the two.

Claim 23

Pulse oximeter according to claim 19, wherein the computation unit comprises at least one rectifier and a high pass filter.

Claim 24

Pulse oximeter according to claim 20, characterized in that the computation unit calculates the ratio between the values representative of the amplitudes of the measurement signal and the ambient light signal as a useful-to-noise-signal ratio or in logarithmic form as a signal-to-noise ratio.

Claim 27

The method of claim 22 wherein the amplitude is detected during the first, second and third intervals by low pass filtering an output signal of the photodetector.

Claim 28

The method of claim 23 wherein the first measure is processed by (a) high pass filtering it to derive a first response and (b) determining absolute value of the first response to derive the first signal, and the second measure is processed by (a) high pass filtering it to derive a second response and (b) determining absolute value of the second response to derive the second signal.

Claim 29

The method of claim 22 wherein the first measure is processed by (a) high pass filtering it to derive a first response and (b) determining absolute value of the first response to derive the first signal, and the second measure is processed by (a) high pass filtering it to derive a second response and (b) determining absolute value of the second response to derive the second signal.

Claim 30

The method of claim 22 wherein the first measure is processed by: (a) analog-to-digital converting it to derive a first digital signal, (b) low pass filtering the first digital signal to derive a second digital signal, (c) high pass filtering the second digital signal to derive a third digital signal, and (d) determining absolute value of the third digital signal to derive the first signal; the second measure being processed by: (a) analog-to-digital converting it to derive a fourth digital signal, (b) low pass filtering the fourth digital signal to derive a fifth digital signal, (c) high pass filtering the fifth digital signal to derive a sixth digital signal, and (d) determining absolute value of the sixth digital signal to derive the second signal.

Claim 31

The method of claim 22 in combination with measuring oxygen saturation of the patient by irradiating tissue of the patient with optical energy having a second wavelength during repeated sequential fourth time intervals, the tissue modifying the second wavelength as a function of oxygen content, further comprising detecting in the photodetector the intensity of the second wavelength as modified during the fourth interval, measuring the intensity of the detected optical energy incident on the photodetector during the fourth time interval, deriving a third measure indicative of the relative values of the measured intensities during the second and fourth intervals, processing the third measure in a predetermined manner to derive a third signal including noise and information used to determine oxygen saturation of the patient, combining the first and third signals to derive a measure of the oxygen saturation of the patient.

Claim 32

The method of claim 22 further including detecting the ambient optical energy incident on the photodetector by recording the intensity of radiation incident on the photodetector during the second and third intervals when the source is switched off, and comparing the amplitudes of the optical energy incident on the photodetector during the second and third time intervals to provide a measure of ambient optical energy incident on the photodetector.

Claim 33

The method of claim 28 wherein the second and third time intervals follow each other directly in any order.

Claim 34

The method of claim 28 wherein the measure of ambient optical energy incident on the photodetector is determined by subtracting the compared amplitudes.

Claim 35

Apparatus for detecting the relative amounts of signal and noise in a pulse oximetry measurement of a patient comprising an optical energy source for irradiating tissue of the patient with a first wavelength during repeated sequential first time intervals, the tissue modifying the first wavelength during the first time intervals as a function of oxygen content, a photodetector for detecting the intensity of the first wavelength as modified during the first intervals, circuitry for measuring the intensity of ambient optical energy incident on the photodetector during the first time intervals as well as during repeated differing sequential second and third time intervals while the optical energy source is inactive and only ambient optical energy is incident on the photodetector, a detector arrangement responsive to the measuring circuitry for detecting the intensity of the optical energy incident on the photodetector during the first, second and third time intervals, first deriving circuitry responsive to the detector arrangement for deriving a first measure of the relative values of the detected intensities during the first and second intervals, second deriving circuitry responsive to the detector arrangement for deriving a second measure of the relative values of the detected intensities during the second and third intervals, first processing circuitry responsive to the first deriving circuitry for processing the first measure in a predetermined manner to derive a first signal including noise and information used to determine oxygen saturation of the patient, second processing circuitry responsive to the second deriving circuitry for processing the second measure in the predetermined manner to derive a second signal indicative of noise in the first signal, and comparing circuitry for comparing the amplitudes of the first and second signals to derive an indication of the relative amount of signal and noise in the intensity of the first wavelength detected by the photodetector during the first interval.

Claim 36

Apparatus for detecting the relative amounts of signal and noise in a pulse oximetry measurement of a patient comprising an optical energy source for irradiating tissue of the patient with a first wavelength during repeated sequential first time intervals, the tissue modifying the first wavelength during the first time intervals as a function of oxygen content, a photodetector for detecting the intensity of the first wavelength as modified during the first intervals, circuitry for measuring the intensity of ambient optical energy incident on the photodetector during the first time intervals as well as during repeated differing sequential second and third time intervals while the optical energy source is inactive and only ambient optical energy is incident on the photodetector, a detector arrangement responsive to the measuring circuitry for detecting the intensity of the optical energy incident on the photodetector during the first, second and third time intervals, first deriving circuitry responsive to the detector arrangement for deriving a first measure of the relative values of the detected intensities during the first and second intervals, second deriving circuitry responsive to the detector arrangement for deriving a second measure of the relative values of the detected intensities during the second and third intervals, first processing circuitry responsive to the first deriving circuitry for processing the first measure in a predetermined manner to derive a first signal including noise and information used to determine oxygen saturation of the patient, second processing circuitry responsive to the second deriving circuitry for processing the second measure in the predetermined manner to derive a second signal indicative of noise in the first signal, and comparing circuitry for comparing the amplitudes of the first and second signals to derive an indication of the relative amount of signal and noise in the intensity of the first wavelength detected by the photodetector during the first interval.

Claim 37

The apparatus of claim 31 further including low pass filter circuitry responsive to an output signal of the photodetector for detecting the amplitude of the incident optical energy during the first, second and third intervals.

Claim 38

The apparatus of claim 32 wherein the first deriving circuitry includes (a) a first high pass filter for deriving a first response and (b) absolute value determining circuitry responsive to the first response for deriving the first signal, the second deriving circuitry including a second high pass filter for deriving a second response, and (c) absolute value determining circuitry responsive to the second response for deriving the second signal.

Claim 39

The apparatus of claim 31 wherein the first deriving circuitry includes (a) a first high pass filter for deriving a first response, (b) absolute value determining circuitry responsive to the first response to derive the first signal, the second deriving circuitry including a second high pass filter for deriving a second response, and (c) absolute value determining deriving circuitry responsive to the second response for deriving the second signal.

Claim 40

The apparatus of claim 31 wherein the first deriving circuitry includes an (a) analog-to-digital converter for converting the first measurement to derive a first digital signal, (b) a low pass filter responsive to the first digital signal for deriving a second digital signal, (c) a high pass filter responsive to the second digital signal for deriving a third digital signal, and (d) absolute value determining circuitry responsive to the third digital signal for deriving the first signal; the second deriving circuitry including: (a) an analog-to-digital converter for converting the second measure for deriving a fourth digital signal, (b) a low pass filter responsive to the fourth digital signal for deriving a fifth digital signal, (c) a high pass filter responsive to the fifth digital signal for deriving a sixth digital signal and (d) absolute value determining circuitry responsive to the sixth digital signal for deriving the second signal.

Claim 41

The apparatus of claim 31 wherein the optical source derives a second wavelength during repeated sequential fourth time intervals, the tissue modifying the second wavelength as a function of oxygen content, the photodetector detecting the intensity of the second wavelength as modified during the fourth interval, the detector arrangement detecting the intensity of the optical energy incident on the photodetector during the fourth time interval, third deriving circuitry for deriving a third measure indicative of the relative values of the detected intensities during the second and fourth intervals, processing circuitry for processing the third measure in a predetermined manner for deriving a third signal including noise and information, and combining circuitry responsive to the first and third signals for deriving a measure of oxygen saturation of the patient.