WO2009133851A1 - Dispositif pour mesurer le degré de saturation de l'oxygène - Google Patents

Dispositif pour mesurer le degré de saturation de l'oxygène Download PDF

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Publication number
WO2009133851A1
WO2009133851A1 PCT/JP2009/058280 JP2009058280W WO2009133851A1 WO 2009133851 A1 WO2009133851 A1 WO 2009133851A1 JP 2009058280 W JP2009058280 W JP 2009058280W WO 2009133851 A1 WO2009133851 A1 WO 2009133851A1
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Prior art keywords
value
oxygen saturation
spo
stability
determination
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PCT/JP2009/058280
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English (en)
Japanese (ja)
Inventor
典浩 舘田
晃宏 鵜飼
繁 大崎
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コニカミノルタセンシング株式会社
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Publication of WO2009133851A1 publication Critical patent/WO2009133851A1/fr

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    • 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

Definitions

  • the present invention relates to an oxygen saturation measuring apparatus for measuring the oxygen saturation of arterial blood.
  • a pulse oximeter oxygen saturation measuring device
  • the pulse oximeter is attached to a predetermined living body part of a subject, outputs light toward the living body part, measures a change in the amount of light transmitted or reflected through the living body part as a signal, Saturation (hereinafter referred to as SpO 2 value) or the like is obtained.
  • Saturation hereinafter referred to as SpO 2 value
  • the SpO 2 value may be measured by a pulse oximeter in the same manner as body temperature measurement.
  • in-patients may be equipped with a pulse oximeter to measure the patient's SpO 2 value as a daily health check.
  • the SpO 2 value temporarily decreases abruptly just by walking. Be measured SpO 2 value in this state, SpO 2 value has changed from time to time, it is impossible to measure the correct value. Therefore, after mounting the pulse oximeter to the patient, until the SpO 2 value is stabilized, it is necessary to visually confirm the SpO 2 value displayed. In this way, the read SpO 2 value is the correct value while the SpO 2 value is stable. This operation is usually performed by a nurse or the like, but since it is confirmed visually, other operations cannot be performed during this period.
  • Patent Document 1 the SpO 2 value displayed at any time, determined the stability of the SpO 2 values, when the SpO 2 value is judged to be stable, without subsequent measurements, at that time
  • An oximeter that displays the displayed SpO 2 value as it is is described.
  • Formula 1 shown below is used for the determination of the stability of the oximeter.
  • DS is a determination value
  • W (I) is a weighting factor.
  • S (0) represents the currently displayed SpO 2 value
  • S (-1) represents the previous SpO 2 value
  • S (-2) displayed the previous two. It represents the SpO 2 value.
  • W (I) is a value determined by I.
  • the determination value DS obtained by Equation 1 indicates that the smaller the value, the less the change in the display SpO 2 value and the higher the stability. Therefore, oximeter described in Patent Document 1, the judgment value DS is equal to or smaller than the predetermined threshold value SpO 2 value is determined to be stable, and fixed displays the SpO 2 values displayed at that time.
  • the display SpO 2 value displayed on the oximeter is a value obtained by, for example, averaging a plurality of consecutive SpO 2 values (instantaneous SpO 2 values) obtained from the optical signal obtained by measurement, It differs from the value obtained by one measurement. Therefore, just because the displayed SpO 2 value does not seem to change much, there is a problem that it cannot be said that the patient's SpO 2 value is actually stable. For example, even if the instantaneous SpO 2 value is unstable, the display SpO 2 value obtained by performing arithmetic processing such as averaging the instantaneous SpO 2 value may be determined to be stable. For this reason, the oximeter described in Patent Document 1 has a problem that although the stability of the SpO 2 value is actually low, it is determined that the SpO 2 value is stable and the SpO 2 value is fixedly displayed. .
  • the present invention has been made in view of the above circumstances, and an object thereof is to provide an oxygen saturation measuring device that performs a determination of whether or not the SpO 2 value is stable by a more reliable method. It is to be.
  • the oxygen saturation measurement apparatus of the present invention includes a stability determination unit that determines the stability of oxygen saturation based on a signal component.
  • the stability determination unit evaluates the signal component, and the signal component has a predetermined evaluation. When the standard is satisfied, it is determined that the oxygen saturation is stable.
  • FIG. 1 is a diagram showing an external configuration of a pulse oximeter according to an embodiment.
  • FIG. 2 is a block diagram showing the configuration of the pulse oximeter according to the embodiment.
  • the pulse oximeter 100 includes a device main body 1 and a measuring unit 2 electrically connected to the device main body 1 via a cable 16.
  • the pulse oximeter 100 is used by being attached to a hand 300 of a subject (patient).
  • the apparatus main body 1 has a mounting belt 17, and the apparatus main body 1 is fixed to the wrist of the subject by, for example, winding the mounting belt 17 around the wrist of the subject.
  • the apparatus body 1 further includes a display unit 6 and an operation unit 8.
  • the display unit 6 is for displaying biological information such as measurement results, that is, blood oxygen saturation (SpO 2 value).
  • the operation unit 8 is, for example, a switch circuit and the like, and is used for instructing reading of measurement results and instructions for starting or ending measurement.
  • the biological information is information serving as an index representing biological information such as the SpO 2 value and pulse of the subject obtained by analyzing an electrical signal obtained from the living body by the pulse oximeter.
  • the measuring unit 2 is attached to the fingertip of the subject, for example. Specifically, it has a shape like a finger sack and is worn by being fitted to the fingertip of the subject. Although not shown in FIG. 1, measurement is performed by the light emitting unit 21 and the light receiving unit 22 installed inside the measuring unit 2 (see FIG. 2).
  • the pulse oximeter 100 includes an apparatus main body 1 and a measurement unit 2.
  • the measuring unit 2 includes a light emitting unit 21 and a light receiving unit 22, and in a state where a measurement site (for example, a fingertip) is fitted in the measuring unit 2, that is, in a measurement state, the light emitting unit 21 and the light receiving unit 22 are interposed between the fingertips. It is arranged so as to face each other. Thereby, biological information can be measured based on the transmitted light of the measurement site. In addition, biological information can also be measured based on the reflected light of the measurement site, and in this case, the light emitting unit 21 and the light receiving unit 22 are arranged adjacent to each other.
  • the light emitting unit 21 is a light source including, for example, a light emitting diode that emits red light having a wavelength in the red region and a light emitting diode that emits infrared light having a wavelength in the infrared region.
  • a light emitting diode that emits red light having a wavelength in the red region
  • a light emitting diode that emits infrared light having a wavelength in the infrared region.
  • the amount of irradiation light can be adjusted within a certain range during measurement. It is preferable to do.
  • the light receiving unit 22 includes a photoelectric conversion element such as a silicon photodiode that generates a current having a magnitude corresponding to the intensity of the received light.
  • the light receiving unit 22 receives light from the light emitting unit 21 that has passed through the fingertip of the subject as the measurement site. Therefore, this photoelectric conversion element has sensitivity to red light and infrared light emitted from the light emitting unit 21.
  • the light receiving unit 22 converts optical signals of red light and infrared light into electrical signals that are biological information signals and outputs the electrical signals.
  • the biological information signal is an electrical signal that depends on the living body of the subject obtained by measurement. More specifically, the biological information can be obtained by analyzing the biological information signal.
  • the apparatus body 1 includes a control unit 4, a storage unit 5, a display unit 6, a power supply unit 7, an operation unit 8, an I / V conversion unit 31, and an A / D conversion unit 32.
  • the storage unit 5 includes a ROM (Read Only Memory) that stores a control program of the pulse oximeter 100, an EEPROM (Electrically Erasable Programmable ROM) that temporarily stores data such as arithmetic processing and control processing, and a RAM (Random Access). Memory) and flash memory.
  • ROM Read Only Memory
  • EEPROM Electrical Erasable Programmable ROM
  • RAM Random Access Memory
  • flash memory flash memory
  • the biological information signal obtained by the measurement unit 2 is analyzed by the analysis processing unit 42, and the light amount and pulse wave amplitude of each light received by the light receiving unit 22, infrared light and red color are obtained.
  • the amplitude ratio with light, the instantaneous SpO 2 value (instantaneous blood oxygen saturation), the display SpO 2 value (displayed blood oxygen saturation), and the like are stored in association with the timing information.
  • the instantaneous SpO 2 value is an SpO 2 value calculated from a biological information signal obtained by one measurement operation.
  • the display SpO 2 value is an average value or a moving average value of a plurality of instantaneous SpO 2 values calculated in a predetermined period, and is a value to be displayed on the display unit 6. Since the instantaneous SpO 2 value is the same value obtained by one measurement, when the instantaneous SpO 2 value is displayed on the display unit 6 for each measurement, the display is displayed when the instantaneous SpO 2 value slightly changes. Flicker. Therefore, it is difficult for the operator to read the displayed value.
  • the average value or the moving average value of the instantaneous SpO 2 values measured in a certain period is displayed on the display unit 6 as the display SpO 2 value.
  • the determination of the stability of the SpO binary value uses data going back for a certain period from the present, but the stored data is stored in association with the timing information in this way, so that past data can be read out. Can be easily performed.
  • the time measurement information may be time from the start of measurement or time.
  • the display unit 6 includes a display device such as an LCD (Liquid Crystal Display), a 7-segment LED (Light Emitting Diode), an organic electroluminescence display device, or a CRT (Cathode Ray Tube) display device.
  • the display unit 6 displays, for example, SpO 2 value, which is measured biological information, and information indicating that the measurement is being performed or a fixed display.
  • the display unit 6 may display lighting, blinking, characters, numbers, symbols, pictorial symbols, characters, and the like.
  • the power supply unit 7 supplies power to the pulse oximeter 100, that is, the measurement unit 2 and the apparatus main body 1. Considering the troublesomeness when the pulse oximeter 100 is mounted, it is desirable to eliminate the need for a power supply cable. Therefore, the power supply unit 7 may include a button battery, a secondary battery, and the like. In addition, it is preferable that the power supply part 7 is provided with the power supply circuit which has a power-off function which stops a power supply automatically, if a measurement is not made for a fixed time.
  • the operation unit 8 is configured with switches and buttons for operating the pulse oximeter 100. Specifically, a switch for turning on / off the power, a switch for instructing measurement start, measurement extension, and various other operations are provided. In addition, a button that can instruct to change the level of the stability determination condition, a stability determination mode in which stability determination is performed and the SpO 2 value is determined to be stable, and continuous measurement that continues measurement A switch or the like for switching the measurement mode is provided.
  • the I / V conversion unit 31 converts a current signal output from the light receiving unit 22 into a voltage signal at a predetermined cycle, and outputs the voltage signal to the A / D conversion unit 32 as a photoelectric pulse wave signal.
  • the A / D conversion unit 32 ⁇ ⁇ converts the photoelectric pulse wave signal, which is an analog biological information signal output from the I / V conversion unit 31, into a digital photoelectric pulse wave signal and outputs it to the control unit 4.
  • the control unit 4 includes various electronic components, integrated circuit components, a CPU (Central Processing Unit), and the like, and controls the operation of each unit of the pulse oximeter 100. Functionally, the measurement control unit 41, the analysis processing unit 42, A stability determination unit 43 and a display control unit 44 are provided.
  • a CPU Central Processing Unit
  • the measurement control unit 41 controls the measurement operation of biological information by the measurement unit 2 according to a predetermined measurement program. Specifically, red light and infrared light are alternately emitted from the light emitting unit 21 at each sampling period, and a photoelectric conversion signal is acquired from the light receiving unit 22 in synchronization with the light emission timing.
  • the display control unit 44 displays the display SpO 2 value and the like calculated by analyzing the biological information signal obtained by the display representing the state under measurement or the measurement by the analysis processing unit 42 in a predetermined display form. Controls the display operation to be displayed.
  • the display control unit 44 causes the display unit 6 to display the SpO 2 value fixedly.
  • the fixed display means that the currently displayed value is continuously displayed (the display is not updated), that is, the display of the displayed blood oxygen saturation is not updated. Accordingly, after being fixed display is performed actual measurement operation, even as different SpO 2 value has been calculated and thereby the displayed value, the SpO 2 value displayed on the display unit 6 does not change .
  • the fixedly displayed value is a value when the SpO 2 value is stabilized
  • the fixedly displayed value is a correct value without variation as the SpO 2 value of the subject.
  • the SpO 2 value is fixed display may be used a display SpO 2 values of arbitrary timing in the period of SpO 2 value is determined to be stable, also, SpO 2 value to be stable determination it may be using the average value of all the listed display SpO 2 values in period.
  • the analysis processing unit 42 performs predetermined data analysis based on the biological information signal obtained by the measurement unit 2, and the light amount and pulse wave amplitude of each light received by the light receiving unit 22, the infrared light and the red light. An amplitude ratio, an instantaneous SpO 2 value, and the like are obtained. Further, an average value or moving average value of instantaneous SpO 2 values in a predetermined period is calculated, and a display SpO 2 value that is a value to be displayed on the display unit 6 is obtained.
  • Oxygen is supplied to each part in the living body by being transported by blood. More specifically, oxygen is transported by oxidation and reduction of hemoglobin in blood. When this hemoglobin is oxidized, the absorption of red light decreases and the absorption of infrared light increases. Conversely, when it is reduced, the absorption of red light increases and the absorption of infrared light decreases. It has characteristics.
  • the analysis processing unit 42 calculates the SpO 2 value using this characteristic. Specifically, first, the variation in the amount of transmitted light of red light and infrared light received by the light receiving unit 22 is measured, and the instantaneous SpO 2 value for each sampling period is calculated based on the amplitude ratio of the red light and infrared light. To do.
  • an average value or a moving average value in a predetermined range of the calculated instantaneous SpO 2 value is obtained, and this is set as a display SpO 2 value.
  • the display SpO 2 value is displayed on the display unit 6 by the display control unit 44. Note that the display SpO 2 value may be calculated every sampling cycle, or may be calculated every predetermined period, for example, every second.
  • the stability determination unit 43 sets at least one of the light amount and pulse wave amplitude of each light received by the light receiving unit 22, the amplitude ratio between infrared light and red light, the instantaneous SpO 2 value, and the display SpO 2 value. Based on this, it is determined whether the SpO 2 value is stable. Specifically, the stability determination unit 43 reads from the storage unit 5 and evaluates the current value and the data obtained by the measurement from the present to the past for a certain period of time. Specifically, the determination value is obtained by substituting the data read from the storage unit 5 into a predetermined calculation formula. The calculation formula is set so that the determination value decreases as the stability of the SpO 2 value increases. Thereby, when this determination value is below a predetermined threshold value, that is, when a predetermined evaluation criterion is satisfied, it is determined that the SpO 2 value is stable.
  • the stability determination unit 43 includes at least the light amount and pulse wave amplitude of each light received by the light receiving unit 22 that is a signal component, the amplitude ratio between infrared light and red light, and the instantaneous SpO 2 value.
  • signal stability is stability of the SpO 2 value is determined on the basis of either stable SpO 2 value is determined based on the display SpO 2 value displayed on the display section 6 that is calculated from the instantaneous SpO 2 value
  • the stability of the SpO 2 value is determined using both the display stability, which is a degree.
  • the pulse oximeter 100 according to the embodiment, the display not only stability, since determining the stability of the signal stability be used SpO 2 value, stability of more reliable SpO 2 value Degree determination can be performed.
  • the signal component for obtaining the signal stability has a plurality of parameters. Therefore, the stability determination unit 43 may evaluate all these parameters to determine the stability of the SpO 2 value, or may evaluate at least one of the parameters to determine the stability of the SpO 2 value. You may judge. A method for evaluating each parameter will be described below. Specifically, each value to be evaluated is individually evaluated, and if each value satisfies a predetermined evaluation criterion, it is determined that the SpO 2 value is stable. More specifically, a determination value is obtained, and when the value is equal to or smaller than a predetermined threshold, it is determined that the SpO 2 value is stable.
  • the determination value may be the reciprocal of the average value of the amount of transmitted light between m points (m is an integer of 1 or more) including the value measured at present. Note that m may be about 10.
  • the determination value DS 11 is expressed by Equation 2 shown below.
  • n (n is an integer of 1 or more) is the number of measurement values from the start of measurement to the present. That is, from the start of measurement, the analysis processing unit 42 has received the biological information signal n times to the present and performs analysis processing.
  • L (k) represents the amount of transmitted light in the kth measurement (m is an integer of 1 or more) from the start of measurement. It is noted that the reason why the determination value DS 11 is the reciprocal of the mean value, the case where the determination value DS 11 is small in order to the high stability of the SpO 2 values.
  • the previously determined a predetermined threshold value, determination value DS 11 is in the following cases the threshold is determined to be high stability of SpO 2 values.
  • a value obtained by the current measurement and a value obtained by the past measurement from the current time are used. Specifically, obtaining a present time, the determination value DS 11 and the value with the m while going back from the current time in the past.
  • the period during which the values used for these determinations are measured is referred to as a determination target period. That is, the measurement unit 2 performs m measurements within the determination target period, and the analysis processing unit 42 receives m pieces of biological signal information from the light receiving unit 22.
  • stability judging unit 43 obtains the determination value DS 11, may determine these the higher stability of the SpO 2 values when more than a predetermined threshold value.
  • the stability determination unit 43 can change the determination target period in accordance with the amount of transmitted light. And the stability determination part 43 should just make the determination object period short, specifically, so that the transmitted light amount is large. In the case of a pulse oximeter that receives reflected light by the light receiving unit 22, the reflected light amount may be used instead of the transmitted light amount.
  • the pulse wave amplitude is evaluated to determine the stability of the SpO 2 value.
  • the pulse wave amplitude also has a poor SN ratio (Signal to Noise Ratio) when the amplitude level is not sufficient. Therefore, the stability of the SpO 2 value can be determined using the average value of the pulse wave amplitude as well as the transmitted light amount.
  • a standard deviation may be used when evaluating the pulse wave amplitude and determining the stability of the SpO 2 value.
  • variation in the magnitude of the pulse wave amplitude may be used as the determination value.
  • the determination value DS 12 when the average value of the pulse wave amplitude is used is expressed by the following Expression 3
  • the determination value DS 13 when the standard deviation of the pulse wave amplitude is used is the following expression: It is represented by 4.
  • Equation 4 l is the same value as k.
  • a (k) and A (l) represent pulse wave amplitudes from the k-th and l-th measurements from the start of measurement. From these equations, the stability determination unit 43 may determine the determination values DS 12 and DS 13 and determine that the stability of the SpO 2 value is high when they are equal to or less than a predetermined threshold.
  • the stability determination unit 43 can change the determination target period according to the magnitude of the pulse wave amplitude. And specifically, the stability determination part 43 should just shorten a determination object period, so that a pulse wave amplitude is large.
  • the determination value DS 14 in this case is represented by Equation 5 shown below.
  • s (k) and s (l) represent instantaneous SpO 2 values obtained by the k-th and l-th measurements from the start of measurement.
  • the stability determination unit 43 may determine the determination value DS 14 and determine that the stability of the SpO 2 value is high when the value is equal to or less than a predetermined threshold.
  • the stability determination unit 43 may determine that the stability of the SpO 2 value is high when the determination value is equal to or less than a predetermined threshold.
  • the threshold value may be about 0.5% of the instantaneous SpO 2 value.
  • the stability determination unit 43 obtains an average value of instantaneous SpO 2 values within a predetermined period, and determines an abnormal value if the value deviates by about ⁇ 5 to 20% or more from the average value, and calculates a determination value. Should not be used.
  • the stability determination unit 43 performs approximation of the linear line using the least square method for each instantaneous SpO 2 value (for m points) within the determination target period, and determines the absolute value of the slope in the linear approximate line. It may be obtained as a value.
  • the determination value calculated in this way indicates a continuous change in the instantaneous SpO 2 value. That is, when the instantaneous SpO 2 value continuously decreases or increases, this determination value becomes relatively large. In such a case, the SpO 2 value is not stable, and the smaller the slope of the approximate line, the higher the stability of the SpO 2 value. Therefore, the stability determination unit 43 may determine that the SpO 2 value is stable when the calculated determination value is equal to or less than a predetermined threshold value. Note that, in the determination based on the instantaneous SpO 2 value, the stability determination unit 43 may use the equation 1 described in Patent Document 1 described above.
  • Stability judging unit 43 in the judgment of the stability of the SpO 2 value according to the instantaneous SpO 2 values, determined the determination value, it is determined that the SpO 2 value when their value is less than the predetermined threshold value is stable Good.
  • the stability determination unit 43 may determine that the SpO 2 value is not stable when the abnormal value is included in a predetermined ratio or more within the determination target period.
  • the abnormal value may be a value that deviates by about ⁇ 5 to 20% or more from the average value of the instantaneous SpO 2 values within a predetermined period, as described above.
  • the instantaneous SpO 2 values since those determined by the amplitude ratio of the infrared light and red light, in the calculation of the decision value using the instantaneous SpO 2 value, infrared light instead of the instantaneous SpO 2 value Alternatively, the amplitude ratio of red light may be used, and a similar determination value can be obtained. Therefore, the above description, in the determination using the instantaneous SpO 2 values may be used amplitude ratio of the infrared light and red light, instead of the instantaneous SpO 2 value. Specifically, the stability determination unit 43 may determine that the SpO 2 value is stable when the standard deviation of the amplitude ratio of infrared light and red light is equal to or less than a predetermined threshold value.
  • the stability determination unit 43 has high stability of the SpO 2 value when the determination value is equal to or less than a predetermined threshold value. May be determined.
  • the threshold value may be about 0.5% of the amplitude ratio of infrared light and red light.
  • the stability determination unit 43 obtains an average value of the amplitude ratio of infrared light and red light within a predetermined period, and determines that it is an abnormal value if the value is more than about ⁇ 5 to 20% or more from the average value. It is sufficient not to use it for calculation of the judgment value.
  • the stability determination unit 43 may determine that the stability of the SpO 2 value is high when the determination value is equal to or less than a predetermined threshold value.
  • the stability determination unit 43 may determine that the SpO 2 value is not stable when the abnormal value is included in a predetermined ratio or more in the determination target period.
  • the abnormal value may be a value that deviates by about ⁇ 5 to 20% or more from the average value of the amplitude ratio of infrared light and red light within a predetermined period.
  • Stability judging unit 43 when determining the stability of the SpO 2 values by the display SpO 2 values, as in the formula 4 or formula 5 may be determined using the standard deviation. Specifically, the stability determination unit 43 replaces s (k) and s (l) indicating the value of the pulse wave amplitude in Equation 5 with the display SpO 2 values obtained by the k-th and l-th measurements from the start of measurement. And the determination value may be obtained.
  • the Stability judging unit 43 Further, as with the determination of the stability of the SpO 2 value according to the instantaneous SpO 2 values, the difference between the maximum value and the minimum value among the measured values within the determination period of these values It is good also as a judgment value.
  • the abnormal value should be deleted from the maximum value and the minimum value. For example, a value that deviates by about ⁇ 5 to 20% or more from the average value of the displayed SpO 2 values within a predetermined determination period may be determined as an abnormal value and not used for calculation of the determination value.
  • the stability determination unit 43 performs approximation of the linear line using the least square method for each display SpO 2 value (for m points) within the determination target period, and determines the absolute value of the slope in the linear approximate line. It may be obtained as a value.
  • stability judging unit 43 similarly to the determination of the stability of the SpO 2 value according to the instantaneous SpO 2 value, calculated determination value, SpO 2 values when more than a predetermined threshold value is stable Can be judged. Note that the determination based on the display SpO 2 value may be performed using Equation 1 described in Patent Document 1 described above.
  • Stability judging unit 43 in the judgment of the stability of the SpO 2 value according to display SpO 2 values, determined the determination value, it is determined that the SpO 2 value when their value is less than the predetermined threshold value is stable Good. Further, the stability determination unit 43 may determine that the SpO 2 value is not stable when the abnormal value is included in a predetermined ratio or more within the determination target period. As the abnormal value, the average value of the display SpO 2 values within a predetermined period may be obtained as described above, and the average value may be a value deviated by about ⁇ 5 to 20% or more.
  • the stability decision unit 43, the signal component and the display SpO 2 values determined the stability of the SpO 2 values, when there is a high both stability, i.e. the signal components and the display SpO 2 value When both are evaluated and both satisfy the predetermined evaluation criteria, it is determined that the SpO 2 value is stable, and the display control unit 44 causes the display unit 6 to display the latest display SpO 2 value in a fixed manner. Specifically, it is represented by the flowchart shown in FIG. FIG. 3 is a flowchart showing stability determination. First, the measurement unit 2 performs measurement (S1).
  • the control unit 4 performs an analysis process on the biological information signal acquired by the measurement unit 2, and the light amount and pulse wave amplitude of each light that is a signal component received by the light receiving unit 22, the amplitude ratio of infrared light and red light. Then, the instantaneous SpO 2 value and the like are calculated (S2). Further, the display SpO 2 value is calculated based on the instantaneous SpO 2 value (S3), and the display SpO 2 value is displayed on the display unit 6 (S4).
  • the stability determination unit 43 determines at least one of the light amount and pulse wave amplitude of each light received by the light receiving unit 22 as a signal component, the amplitude ratio between infrared light and red light, and the instantaneous SpO 2 value.
  • SpO 2 value stability determination is performed based on the determination value DS 1 used. Specifically, first, stability judging unit 43 reads the data while going back the current value and the current in a predetermined period past from the storage unit 5, and calculates the determination value DS 1 based on them (S5) . The stability judging unit 43, the determination value DS 1 To assess whether a predetermined threshold TH 1 or less (S6).
  • the process returns to step S1 again. If the determination value DS 1 is less than or equal to the threshold value TH 1 , the stability determination unit 43 determines the determination value DS 2 using the display SpO 2 value. SpO 2 value stability determination based on Specifically, first, stability judging unit 43 reads the data while going back the current value and the current in a predetermined period past from the storage unit 5, to calculate a decision value DS 2 based on them (S7) . The stability judging unit 43, the determination value DS 2 To assess whether a predetermined threshold TH 2 below (S8).
  • step S1 If the determination value DS 2 is not the threshold TH 2 or less, process returns to step S1, if the determination value DS 2 the threshold TH 2 or less, on the display unit 6 is a display control unit 44, the latest display value i.e. currently displayed The SpO 2 value is fixed and displayed (S9). Note that after the fixed display, the measurement is not performed.
  • the pulse oximeter 100 includes a buzzer, a vibration device, an LED (Light Emitting Diode), or the like. When the pulse oximeter 100 is fixedly displayed, SpO 2 is transmitted to the operator by sound, vibration, or light. The fact that the value is stable is notified (S10).
  • stability judging unit 43 may be used at least one determination method of the determination method indicated above. Moreover, the stability determination part 43 may perform by using one determination value, and may perform determination using a some determination value. Furthermore, when using a plurality of determination values, the stability determination unit 43 may determine that the SpO 2 value is not stable unless all of the plurality of determination values used for the determination are equal to or less than the threshold. It is also possible to determine that the SpO 2 value is stable if the number or the determination value of a predetermined ratio is equal to or less than the threshold value.
  • the degree of the determination level may be changed stepwise. That is, it is preferable that the stability determination unit 43 can change the threshold stepwise. It should be noted that the stricter the determination level, the smaller the measurement value used for the determination, and the lower the determination level, the more the measurement value used for the determination.
  • the determination target period may be shortened as the determination level is stricter (the threshold value is small). Thereby, when the stability of the SpO 2 value is high, since the determination target period is short by setting the determination level to be strict, measurement can be performed in a short time.
  • the pulse oximeter 100 is attached to the subject's hand 300, and the operation unit 8 is operated to start measurement.
  • the operation unit 8 is operated to start measurement.
  • stability determination is performed and if it is determined that the SpO 2 value is stable, a stability determination mode in which the display is fixed, and continuous measurement is continued regardless of the value of the SpO 2 value. It is preferable that one of the measurement modes can be selected.
  • the measurement control unit 41 controls the light emitting unit 21, the light receiving unit 22, the I / V conversion unit 31, and the A / D conversion unit 32 to perform SpO 2. Measurement of biological information such as values is performed.
  • the measurement control unit 41 causes the light emitting unit 21 to emit light and causes the light receiving unit 22 to acquire a photoelectric conversion signal that is a biological information signal in synchronization with the light emission timing. Further, the photoelectric conversion signal acquired by the light receiving unit 22 is a current signal, is converted into a voltage signal by the I / V conversion unit 31, and is output to the A / D conversion unit 32 as a photoelectric pulse wave signal.
  • the measurement control unit 41 causes the A / D conversion unit 32 to convert the photoelectric pulse wave signal from analog to digital.
  • the analysis processing unit 42 performs a predetermined analysis based on the digital photoelectric pulse wave signal output from the A / D conversion unit 32, and the light amount and pulse wave amplitude of each light received by the light receiving unit 22 and infrared light. An amplitude ratio with red light, an instantaneous SpO 2 value, a display SpO 2 value, and the like are calculated.
  • the display control unit 44 causes the display unit 6 to display the display SpO 2 value calculated by the analysis processing unit 42.
  • the analysis processing unit 42 stores the calculated various parameters in the storage unit 5 together with the timing information.
  • the parameters stored in the storage unit 5 may be only those used for stability determination.
  • the stability determination unit 43 When the stability determination mode is selected by the operation unit 8, the stability determination unit 43 reads the parameters in the past measurement used for the stability determination from the storage unit 5, and stabilizes the SpO 2 value by the method described above. Judge the degree. Note that, as described above, in the case of having multi-level determination levels, the operator may select a desired determination level using the operation unit 8. Thereby, the stability determination part 43 performs the stability determination of a predetermined determination level within a predetermined determination target period.
  • the stability determination unit 43 may extend the determination target period and continue the determination. Specifically, for example, the stability determination unit 43 may change the determination level, and the determination level may be changed to a stricter determination level than the initially set determination level. That is, if it is not determined that the SpO 2 value is stable within the determination target period, it can be determined that the degree of instability of the SpO 2 value is high, and therefore the determination of the stability of the SpO 2 value is further continued. By making the conditions stricter, it is possible to realize a more reliable determination of the stability of the SpO 2 value.
  • the stability determination unit 43 determines that the SpO 2 value is stable, the stability determination unit 43 sends an instruction to that effect to the display control unit 44. Therefore, the display control unit 44 causes the display unit 6 to display the latest display SpO 2 value in a fixed manner.
  • the pulse oximeter 100 may be provided with a buzzer, a vibration device, an LED, or the like, and when fixedly displayed, the pulse oximeter 100 may be configured to notify the operator of the fixed display by sound, vibration, or light. . In this way, by notifying that the SpO 2 value has stabilized, the operator can know that the SpO 2 value has been stabilized and the fixed display has been made without looking at the display unit 6.
  • the measurement control unit 41 may stop the measurement. Moreover, the power supply part 7 should just stop a power supply automatically, if measurement for a fixed time is not made. As a result, the power source of the pulse oximeter 100 is automatically turned off after a fixed time has elapsed since the fixed display has been made, thus providing an energy saving effect.
  • the display control unit 44 displays the display SpO 2 value that is fixedly displayed when the display unit 6 is automatically turned off. The unit 6 may be controlled.
  • the operator can read the value when the SpO 2 value is stable without continuing to look at the display of the pulse oximeter. Moreover, since the reliability of the determination of the stability of the SpO 2 value is high, it can be said that the fixedly displayed value is a value in a state where the fluctuation of the SpO 2 value is small and is a correct measured value. Therefore, the pulse oximeter 100 according to the present embodiment allows the operator to correctly measure the SpO 2 value.
  • the determination of the stability of the SpO 2 value may be performed by another method other than the determination based on the display stability and the signal stability as described above.
  • the determination of the stability of the SpO 2 value may be performed only based on the signal stability.
  • the signal component is the value obtained by the measurement, since determining the stability of the SpO 2 values, reliable in stability judgment.
  • at least two values are included among the light amount and pulse wave amplitude of each light received by the light receiving unit 22, the amplitude ratio of infrared light and red light, the instantaneous SpO 2 value, the display SpO 2 value, and the like.
  • the SpO 2 value may be determined to be stable. More specifically, when evaluation is performed on at least two values of the signal component calculated by the analysis processing unit 42 without performing evaluation based on the display SpO 2 value, and all of these satisfy a predetermined evaluation criterion, The SpO 2 value may be determined to be stable. Further, signals calculated by the analysis processing unit 42, such as the light amount and pulse wave amplitude of each light received by the light receiving unit 22, the amplitude ratio of the infrared light and the red light, the instantaneous SpO 2 value, the display SpO 2 value, and the like. If only one value is evaluated among the components and this value satisfies a predetermined evaluation criterion, the SpO 2 value may be determined to be stable. This increases the degree of freedom in determining the stability of the SpO 2 value.
  • FIG. 4 is a flowchart showing an example of the operation of the pulse oximeter according to the embodiment.
  • the pulse oximeter 100 based on the stability and display SpO 2 value of the instantaneous SpO 2 value to determine the stability of the SpO 2 values.
  • the evaluation of the instantaneous SpO 2 value is performed based on the difference between the maximum value and the minimum value.
  • the measurement unit 2 performs measurement (S11).
  • the determination time T is measured by a timer function provided in the CPU. Therefore, the determination time T is set to 0 at the start of measurement, and measurement of the determination time is started.
  • the analysis processing unit 42 performs an analysis process on the biological information signal acquired by the measurement unit 2 and calculates an instantaneous SpO 2 value (S12).
  • the predetermined determination target period T 0 is compared with the determination time T (S13). If T is equal to or less than T 0 , that is, if the determination target period T 0 has not elapsed, the process returns to step S11 again.
  • the stability determination unit 43 reads the instantaneous SpO 2 value calculated in the determination target period T 0 and stored in the storage unit 5. An abnormal value is deleted from them (S14). Furthermore, the stability determination unit 43 calculates the difference between the maximum value and the minimum value in the instantaneous SpO 2 value from which the abnormal value is deleted (S15). Here, the difference between the maximum value and the minimum value is the determination value DS 1 at the instant SpO 2 value. Further, stability judging unit 43, a judgment value DS 2 of the display SpO 2 values within the determination target period T 0 is calculated by the above method (S16). The determination value DS 2 is, for example, like the instantaneous SpO 2 value may be a difference between the maximum value and the minimum value of the display SpO 2 values.
  • stability judging unit 43 the calculated determination value DS 1 To assess whether a predetermined threshold TH 1 or less (S17). If the determination value DS 1 is the threshold TH 1 or less, the stability determination unit 43 performs evaluation based on the determination value DS 2 using the display SpO 2 values. Specifically, stability judging unit 43, the determination value DS 2 To assess whether a predetermined threshold TH 2 or less (S18).
  • the display control unit 44 on the display unit 6 the latest display value ie is fixed displays the SpO 2 value currently displayed, comprising a pulse oximeter 100, a buzzer, vibration The operator notifies the operator that the SpO 2 value has been stabilized by sound, vibration, or light from the device or the LED (S19), and the process ends.
  • step S17 in a case and S18 determination value DS 1 is not the threshold TH 1 or less, if the determination value DS 2 is not the threshold TH 2 below, fixed display is not performed, the display control unit 44 The latest display SpO 2 value is updated and displayed on the display unit 6 (S20). Furthermore, the control unit 4 measures the time from the start of measurement using, for example, a timer function provided in the CPU, and determines whether or not a predetermined time has elapsed since the start of measurement (S21). The predetermined time may be about 30 seconds, for example. Further, the determination of the elapse of the predetermined time (step S21) may be omitted. In this case, if it is not determined to be stable, the determination target period is extended each time.
  • the measurement unit 2 returns to step S11 and continues measurement. If the predetermined time has not elapsed, the stability determination unit 43 extends the determination target period by ⁇ (S22), and the extended determination target period is applied in the next stability determination. Also, the determination condition is changed. Specifically, stability judging unit 43 changes the threshold value TH 1 and the threshold TH 2 values of the threshold TH 12 and the threshold value TH 22, respectively (S23). And it returns to step S11 again and repeats the above-mentioned operation.
  • the pulse oximeter according to the embodiment of the present invention, it is possible to determine whether or not the SpO 2 value is stable by a more reliable method.
  • the oxygen saturation measuring apparatus is an apparatus for measuring oxygen saturation in blood, which irradiates a living body with infrared light and red light and emits light that has passed through the living body.
  • a measurement unit that obtains a biological information signal by receiving light
  • an analysis processing unit that analyzes the biological information signal and calculates a signal component from the biological information signal, and the oxygen based on the calculated signal component
  • a stability determination unit that determines the stability of the saturation, and the stability determination unit evaluates the signal component, and the oxygen saturation is stabilized when the signal component satisfies a predetermined evaluation criterion. It is determined that
  • the stability of the oxygen saturation in the blood is determined based on the signal component that is the measured value, not the average value of the measured value, as in the displayed blood oxygen saturation. High reliability.
  • the signal component includes a light amount component of the received light, a pulse wave amplitude of the received light, and infrared light and red light of the received light. It is preferable to include at least one of the amplitude ratio and the instantaneous blood oxygen saturation.
  • the analysis processing unit calculates a plurality of signal components from the biological information signal, and the stability determination unit calculates at least two values of the plurality of signal components. It is preferable to evaluate each individually and determine that the oxygen saturation is stable when all of them satisfy a predetermined evaluation criterion.
  • the stability of the oxygen saturation level in the blood is determined based on at least two values of the plurality of signal components, the reliability in the stability determination is high.
  • the analysis processing unit further analyzes the biological information signal to calculate a displayed blood oxygen saturation
  • the stability determination unit includes at least one of the above-described stability determination units. It is preferable to individually evaluate the signal component and the displayed blood oxygen saturation, and determine that the oxygen saturation is stable when all of them satisfy a predetermined evaluation criterion.
  • the stability of the oxygen saturation level in the blood is determined based on both the signal component and the displayed blood oxygen saturation level, the reliability in the stability determination is high.
  • the oxygen saturation measurement apparatus further includes a display unit that displays the displayed blood oxygen saturation, and the display unit determines that the oxygen saturation is stable when the oxygen saturation is stable. Is determined, it is preferable not to update the display of the displayed blood oxygen saturation.
  • the display of the displayed blood oxygen saturation is not updated, so that the operator can display the displayed blood oxygen saturation fixedly. Therefore, it can be easily recognized that the oxygen saturation level in the blood is stable. Further, by reading the value, the display blood oxygen saturation with high reliability can be read.
  • the oxygen saturation measuring apparatus further includes a display unit that displays the displayed blood oxygen saturation, and the display unit is configured so that any one of the evaluated values is a predetermined evaluation criterion. If not, it is preferable to keep displaying the displayed blood oxygen saturation calculated by the analysis processing unit as needed.
  • the displayed blood oxygen saturation displayed on the display unit is updated as needed based on the value obtained by the measurement. Therefore, the operator can easily recognize that the oxygen saturation level in the blood is not stable by looking at the display unit.
  • the stability determination unit may evaluate each value of the amplitude ratio of the infrared light and the red light or the instantaneous blood oxygen saturation in the received light. The evaluation is preferably performed based on the difference between the maximum value and the minimum value of the respective values within the determination target period. In the evaluation of each value, the value obtained by the current measurement and the value obtained by the past measurement from the current time are used, and the period during which the value used for the evaluation is measured is referred to as a determination target period.
  • the maximum value and the minimum value are selected from among abnormal values deleted from the respective values within the determination target period.
  • the abnormal value is deleted from the value for evaluating each value, thereby realizing a more reliable determination of the stability of oxygen saturation in blood.
  • the abnormal value is determined based on an average value of the respective values within the determination target period.
  • the stability determination unit may include the pulse wave amplitude of the received light, the amplitude ratio of infrared light and red light of the received light, or the instantaneous In the evaluation of each value of blood oxygen saturation, it is preferable to perform the evaluation based on the standard deviation value of each value within the determination target period.
  • the stability determination unit determines the amplitude ratio of infrared light and red light or the instantaneous blood oxygen saturation value in the received light. It is preferable to determine that the oxygen saturation is not stable if the ratio of abnormal values is equal to or greater than a predetermined ratio among the values within the target period.
  • the stability determination unit may evaluate each value of the amplitude ratio of the infrared light and the red light or the instantaneous blood oxygen saturation in the received light. It is preferable that a primary approximate line is obtained from the respective values in the determination target period by a least square method and the evaluation is performed based on the absolute value of the slope of the primary approximate line.
  • the stability determination unit extends the determination target period when any of the plurality of signal components does not satisfy a predetermined evaluation criterion within the determination target period. In addition, it is preferable to change the evaluation criteria.
  • the evaluation standard can be changed and the evaluation target period can be extended to continue the evaluation. For example, if any of the plurality of signal components does not meet the predetermined evaluation criteria within the determination target period, it can be determined that the degree of instability of the oxygen saturation in the blood is high, and the evaluation is continued further.
  • the evaluation criteria should be made stricter. Thereby, a more reliable determination of the stability of the oxygen saturation in the blood is realized.
  • the evaluation criterion includes a plurality of evaluation criteria that are different in stages, and there are determination target periods corresponding to the respective stages of the evaluation criterion
  • the stability determination unit includes: Preferably, the evaluation is performed within the determination target period corresponding to the evaluation criterion by using any one of the evaluation criteria.
  • the level of reliability in determining the stability of the oxygen saturation can be maintained. For example, when the evaluation standard is strict, the determination target period may be shortened. Therefore, when the stability of oxygen saturation in the blood is high, the evaluation criteria are stricter, thereby shortening the determination target period, so that the measurement time can be shortened without lowering the reliability of stability determination.
  • the stability determination unit may determine the magnitude of each value in the evaluation of each value of the light amount component of the received light and the pulse wave amplitude of the received light. Accordingly, it is preferable to change the determination target period.
  • the determination target period may be shortened as each value increases.
  • the stability determination unit determines that the blood oxygen saturation is stable, it is preferable to notify that the oxygen saturation is stable. .

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Abstract

L'invention porte sur un dispositif pour mesurer le degré de saturation de l'oxygène pour mesurer le degré de saturation de l'oxygène dans le sang, qui comprend : une partie de mesure dans laquelle un corps vivant est exposé à de la lumière infrarouge et à de la lumière rouge et la lumière passant à travers le corps vivant est reçue pour ainsi obtenir des signaux de données concernant le corps vivant ; une partie d'analyse et de traitement dans laquelle les signaux de données concernant le corps vivant sont analysés et traités pour ainsi calculer des composants de signal ; et une partie de détermination de stabilité dans laquelle la stabilité du degré de saturation de l'oxygène est déterminée sur la base des composants de signal ainsi calculés ; dans la partie de détermination de stabilité, les composants de signal sont évalués de telle sorte que le degré de saturation de l'oxygène est considéré stable dans le cas où les composants de signal satisfont des critères d'évaluation définis.
PCT/JP2009/058280 2008-04-30 2009-04-27 Dispositif pour mesurer le degré de saturation de l'oxygène WO2009133851A1 (fr)

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Cited By (4)

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Publication number Priority date Publication date Assignee Title
WO2014050945A1 (fr) * 2012-09-28 2014-04-03 シスメックス株式会社 Dispositif de mesure de corps vivant non invasif
EP3473171A4 (fr) * 2016-06-15 2020-06-17 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Procédé de calcul de paramètres physiologiques et équipement médical correspondant
CN112399819A (zh) * 2018-07-02 2021-02-23 3M创新有限公司 用于监测时间相关过程的传感系统和方法
JP7458869B2 (ja) 2020-04-09 2024-04-01 日本光電工業株式会社 生体信号処理装置、生体信号処理プログラム、および生体信号処理方法

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JPH02237544A (ja) * 1989-03-10 1990-09-20 Minolta Camera Co Ltd オキシメータ
JPH0732767B2 (ja) * 1986-03-19 1995-04-12 ミノルタ株式会社 オキシメータ
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JPS60176624A (ja) * 1984-02-23 1985-09-10 ミノルタ株式会社 動脈血酸素飽和度測定装置
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014050945A1 (fr) * 2012-09-28 2014-04-03 シスメックス株式会社 Dispositif de mesure de corps vivant non invasif
CN104661595A (zh) * 2012-09-28 2015-05-27 希森美康株式会社 无创生物测量装置
JPWO2014050945A1 (ja) * 2012-09-28 2016-08-22 シスメックス株式会社 非侵襲生体計測装置
EP3473171A4 (fr) * 2016-06-15 2020-06-17 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Procédé de calcul de paramètres physiologiques et équipement médical correspondant
US11154250B2 (en) 2016-06-15 2021-10-26 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Methods and systems for calculating physiological parameters
US11872060B2 (en) 2016-06-15 2024-01-16 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Methods and systems for calculating physiological parameters
CN112399819A (zh) * 2018-07-02 2021-02-23 3M创新有限公司 用于监测时间相关过程的传感系统和方法
JP7458869B2 (ja) 2020-04-09 2024-04-01 日本光電工業株式会社 生体信号処理装置、生体信号処理プログラム、および生体信号処理方法

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