WO2007056995A1 - Etalonnage auto-adaptatif - Google Patents

Etalonnage auto-adaptatif Download PDF

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Publication number
WO2007056995A1
WO2007056995A1 PCT/DE2006/002013 DE2006002013W WO2007056995A1 WO 2007056995 A1 WO2007056995 A1 WO 2007056995A1 DE 2006002013 W DE2006002013 W DE 2006002013W WO 2007056995 A1 WO2007056995 A1 WO 2007056995A1
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WO
WIPO (PCT)
Prior art keywords
constant
measured value
body tissue
variable
physiological
Prior art date
Application number
PCT/DE2006/002013
Other languages
German (de)
English (en)
Inventor
Klaus Forstner
Original Assignee
Weinmann Geräte für Medizin GmbH & Co. KG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Weinmann Geräte für Medizin GmbH & Co. KG filed Critical Weinmann Geräte für Medizin GmbH & Co. KG
Priority to DE112006002808T priority Critical patent/DE112006002808A5/de
Publication of WO2007056995A1 publication Critical patent/WO2007056995A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1495Calibrating or testing of in-vivo probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455Measuring 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0223Operational features of calibration, e.g. protocols for calibrating sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/72Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7203Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
    • A61B5/7207Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise induced by motion artifacts

Definitions

  • the invention relates to a method for calibration which adapts to individual measuring properties of patients, called "autoadaptive calibration".
  • the method according to the invention serves to correct the results of the measurement of physiological variables.
  • the results can be influenced by physiological and / or external influences.
  • measured value variables are extracted from the results, which serve to determine correction factors.
  • the results of the measurement of physiological quantities are linked by mathematical relationships with the correction factors in order to compensate the physiological and / or external influences individually and automatically.
  • the calibration function G is a mathematical relationship of measured value variables MV of the results of the measurement of physiological variables and a target value Z, which are obtained on a collective of test persons, in order to be applied to all subsequent patient measurements. Simplified, the relationship between Z and MV is as follows:
  • the function G transfers the measured value variables MV into the desired target variable Z and is therefore called a calibration function.
  • ADAPTIVE calibration If the functional relationship between the measured value variables MV and the target variable Z is constant, this is called a KONSTANT calibration. If the calibration function G itself depends on further parameters that are obtained from the measuring system in the course of the measurement, this is called ADAPTIVE calibration.
  • K 0 and Ki are constant quantities that can be applied to all patient measurements, a constant calibration is available.
  • adaptive type calibration functions are proposed for use in medicine. This can be a dynamic compensation of physiological and / or external parameter changes of the measurement, such as changes in sensor position, sensor compression of the tissue, patient movements, volume changes in the tissue and / or vessels involved, varying blood fillings or the influence of specific histoanatomy during the Carry out the measurement.
  • the determination of the target variable Z is carried out via the calibration function G, and this in turn depends on system parameters K and measured value variables MV.
  • Measurement variables MV are computational variables resulting from the measurement of physiological magnitudes P.
  • the Meßswert- variables are with these physiological quantities P on the
  • Target variables can be any number of measured value variables, physiological base parameters and system parameters.
  • the physiological parameters represent measurement results of the recorded patient plethysmograms
  • the measured value variables are generated by linking the plethysmogram values and the system parameters result from the place of application, the measurement methodology (transmission or reflection) as well as the electrophotographic and mechanical sensor construction.
  • K v fixed, ie constant system parameters.
  • P v physiological basic parameters
  • MV ⁇ measured value variables derived from the physiological basic parameters.
  • K v f (MVv (Pv) / Pv) ••• variable variable K ⁇ which depends on the measured value variables MV V and on the parameters P v that determine the measured value variables.
  • the adaptive calibration can be homogeneous or inhomogeneous:
  • parameters P y occur. This is the inhomogeneous adaptive calibration and applies to these:
  • initial adaptive calibration If this adaptation of the calibration to individual system properties is performed only once, namely initially for the measurement, this is called initial adaptive calibration.
  • Auto-adaptive calibration has the advantage that it automatically corrects all system changes during a measurement by continually adjusting the calibration to them.
  • the inventive method can be applied according to an embodiment in the non-invasive and continuous measurement of the absolute hemoglobin concentration in the blood.
  • electromagnetic radiation at different radiation frequencies is passed through a vessel and / or tissue containing the blood, and at least a portion of the radiation emerging from the vessel and / or tissue is detected by sensors and sent to an evaluation.
  • the invention can furthermore be embodied in a device for measuring further constituents in the blood, which has at least one emission source for generating electromagnetic radiation and for detecting a transmission component or reflection component of the radiation, which sensor is connected to an evaluation device.
  • a device for measuring further constituents in the blood which has at least one emission source for generating electromagnetic radiation and for detecting a transmission component or reflection component of the radiation, which sensor is connected to an evaluation device.
  • the determination of the concentration of hemoglobin is clinically significant. Previous methods are associated with a blood sample and subsequent laboratory tests.
  • the total concentration of hemoglobin is composed of the functional Hb components, namely the oxyhemoglobin (HbO 2 ) and the deoxygenated hemoglobin (HbDe), as well as the dyshemoglobins (HbDys). HbDe and HbO 2 are used for oxygen transport.
  • the dysfunctional hemoglobin derivatives such as carboxyhemoglobin (COHb), methemoglobin (MetHb) and sulfhemoglobin (HbSuIf) are not able to reversibly store oxygen. If these derivatives increase in blood, they can significantly reduce the transport capacity of hemoglobin for O 2 and thus lead to hypoxemia.
  • COHb carboxyhemoglobin
  • MetHb methemoglobin
  • HbSuIf sulfhemoglobin
  • At least one source of electromagnetic radiation and, in a specific arrangement, at least one photoreceiver are arranged in relation to the biological tissue to be examined.
  • the sources of electromagnetic radiation may include different wavelengths and are passed through the tissue.
  • measuring signals are then fed to the photoreceiver of an evaluation device.
  • the evaluation device determines at least one measured value variable MV depending on the number of wavelengths.
  • the measured value variable consists of at least two physiological parameters Parameters P, wherein at least one parameter P represents a variable size of the vessel and / or tissue at the time of beam passage.
  • At least one measured value variable MV is linked to at least one parameter and at least one determination constant K.
  • the result of the linkage represents the target variable Z, namely the concentration c of at least one constituent of the body tissue at the time of the beam passage.
  • a portion of the electromagnetic waves that has passed through the tissue is detected by a receiving system.
  • the receiving system has a spectral bandwidth which makes it possible to detect a wide range of wavelengths which preferably strike the receiving system repetitively at a time interval of less than 0.5 sec.
  • the detected electromagnetic waves are subsequently processed by signal conditioning. Their amplitude is weighted depending on the emitted wavelength. This can e.g. be realized by activated filter functions and / or reinforcing elements.
  • a particularly simple metrological structure can be achieved by using electromagnetic radiation in the ultraviolet, visible and infrared frequency ranges.
  • the source emits electromagnetic radiation of at least two wavelengths selected from a range of substantially 300 nm to 1800 nm. Preferably, however, not exclusively selected from the following wavelengths:
  • the method of pulse spectroscopy can be used for the measurement. This determines the absolute or relative concentration of certain substances by measuring pulsatile perfusion curves at different wavelengths with reference to known absorption spectra of biological substances.
  • an analyzer determines from these signals at least one measured value variable (MV).
  • each measured value variable MV AB can be made up of M A parameters P A and M 8 parameters P 8 .
  • MV AB f (PAI .-. PAMA; PBI .-. PBMB)
  • a typical, but not exclusive, application example is that the concentration of total hemoglobin (c Hb ) is determined.
  • the concentration of oxyhemoglobin (HbO 2 ) and / or deoxygenated hemoglobin (HbDe) and / or carboxyhemoglobin (HbCO) and / or methemoglobin (HbMet) and / or sulfhemoglobin (HbSuIf) can also be determined.
  • HbX any substance concentration which results from the addition and / or binding of a substance X to Hb
  • concentrations of non-hemoglobin-associated components will be determined. This applies to both native and iatrogenically applied blood substances. An application example is that both derivatives of bilirubin and the total concentration of bilirubin is determined. It is also possible that a concentration of myoglobin and troponin is determined. The invention also contemplates the determination of the concentration of glucose and / or insulin.
  • the concentration of total hemoglobin is composed of the proportions of the hemoglobin fractions.
  • cHbDe concentration of deoxygenated hemoglobin
  • cHbCO concentration of the carboxylated hemoglobin
  • cHbMet concentration of methemoglobin
  • cHbSulf concentration of SuIf - hemoglobin
  • CHbO 2 the concentration of oxygenated hemoglobin
  • Hematuration of hemoglobin sa02 Oxygen saturation of hemoglobin saCO: Carbon monoxide saturation of hemoglobin saMet: Methemoglobin saturation
  • are the molar extinction coefficients underlying the respective substances, c the respective concentrations, d k is the total thickness of the constant tissue.
  • dA (t) is the pulse-cyclic time-dependent thickness of the pulsating blood vessels. If two times t x and t 2 are considered, the weakening fraction of the constant tissue is eliminated:
  • is a wavelength-dependent variable, which depends on the extinction coefficients of the substances of the pulsating blood space as well as their Hb saturations as well as on the extinction of water and the relative concentration c H 2o / c H b.
  • partial pulse modulation PPM partial pulse modulation
  • total pulse modulation TPM total pulse modulation
  • XPM is set for the terms PPM and TPM, so: XPM e ⁇ PPM, TPM ⁇ . ,.
  • ⁇ I and I and thus XPM are physiological measurement parameters P, which are incorporated into the formation of measured value variables MW.
  • the parameters have physiological significance, and are in the present case a measure of the pulse-cyclic change in vessel thickness.
  • ⁇ A and ⁇ B are used to form a measured value variable by means of the parameters P. This is called ⁇ AB :
  • ⁇ AB is the measured value variable with respect to the two wavelengths ⁇ A / ⁇ a.
  • the hemoglobin concentration is to be determined as a linear function of the measured variable ⁇ AB .
  • the determination equations for the hemoglobin concentration c H b exemplified here contain a measured value variable ⁇ AB , which in turn is formed by the system parameters XPM A and XPM B.
  • the basic relationship (A) is considered:
  • the target variable Z in this case is c H b-
  • the first measured value variable used here is ⁇ AB .
  • the determination of hemoglobin saturation in the hemoglobin partial parameters ⁇ A and ⁇ B requires further measured value variables.
  • the parameters XPM of each wavelength are included in these measured value variables.
  • the described equation (A) includes extinction coefficients ⁇ , which are determined in biological tissues by two basic processes:
  • the determination of the total hemoglobin concentration according to (A) requires the consideration of the tissue / thickness and substance - specific size change of the extinction coefficients in the tissue.
  • the adaptive calibration corrects the following influences:
  • Each extinction coefficient ⁇ of a substance x depends on physiological basic quantities such as imine and TPM. This applies to all wavelengths A, B which contribute to the formation of a measured value variable MV A B.
  • the parameter ⁇ x depends on the spectroscopically recorded basic parameters:
  • ⁇ x f (imine ( ⁇ A ); imine ( ⁇ B ); TPM ( ⁇ A ); TPM ( ⁇ B ))
  • a 2 SHbDe (A 2 ), SHbO 2 (A 2 ), SHbCO (A 2 ), SH 2 O (A 2 )
  • a 3 ⁇ HbDe (A 3 ), SHbO 2 (A 3 ), SHbCO (A 3 ), SH 2 O (A 3 )
  • a 4 SHbDe (A 4 ), SHbO 2 (A 4 ), SHbCO (A 4 ), SH 2 O (A 4 )
  • At least one of the extinctions is corrected by means of the (auto) adaptive calibration.
  • at least two extinctions are corrected by means of the autoadaptive calibration.
  • the correction takes place, for example, according to the following formula:
  • ⁇ (Ay, sub, Ax) Adaptive calibration parameter which corrects the absorbance value of the substance sub at the wavelength Ax by the influence of the total pulse modulation TPM at the wavelength Ay.
  • ⁇ (Ay, sub, Ax) Adaptive calibration parameter which measures the extinction value of the substance sub at the wavelength Ax corrected the influence of a spectroscopically measured variable at the wavelength Xy.
  • k (sub, Xx) Adaptive multiplier of the base value of the extinction coefficient of the substance sub at the wavelength ⁇ x.
  • the corrections are made according to a correction table representing the total amount of adaptive calibration. This is exemplified below for the wavelength X A • '
  • correction factors ⁇ , ⁇ and ⁇ are empirically determined, statistically verified using a reference collective, and are provided in the area of the device in a nonvolatile memory and / or are transmitted electronically, optically or electromagnetically for calibration.
  • the functional relationship between the adaptive parameters P, which change the extinction coefficients as system parameters, is also based on an empirical reasoning Statistical analysis based on calibration data.
  • At least one linking function which is suitable for sufficiently correcting the transcutaneous measured values.
  • linking functions in the region of the device are preferably executable.
  • the selection is made to which linking functions are to be applied, for example in the case of a plausibility check of the transcutaneous measured values.
  • linking function it is also thought possible to allow the user to select the linking function to be used. For example, depending on age and / or physiology and / or skin color, a physician may dictate the linkage function to be used.
  • the selection of linking functions is particularly preferably carried out automatically, for example, after inputting relevant information. Turning data and / or a plausibility check of transcutaneous measured values.
  • the linking function is retrievably stored in a non-volatile memory, which can be arranged in the region of a CPU.
  • the selection of the linking function is particularly advantageously carried out via a look-up table.
  • Figure 5 shows the effectiveness of auto-adaptive calibration in signal stabilization
  • Fig. 6 shows a typical layer model for illustrating the principles of pulse spectroscopy.
  • Fig. 3 shows the influence of the variation of MV Imine (venous blood filling), TPM (thickness change) and Omega - each for two wavelengths - on the cHb concentration.
  • the percentage change is between 30% and 110%.
  • the determined concentration for cHb changes due to the fluctuation the TPM parameter by 1 g / dl.
  • FIG. 1 illustrates the need to compensate for the variation in MV by calibration.
  • K v constant.
  • the fluctuation of the cHb value by +/- 2 g / dl within a short period of time can be recognized.
  • FIG. 5 shows the effectiveness of auto-adaptive calibration in signal stabilization.
  • a movement of the patient takes place. Due to the movement, the measurement signal for cHb becomes inaccurate.
  • Autoadaptive calibration (7) almost completely compensates for the motion artifact and stabilizes the cHb reading.
  • the auto-adaptive calibration is used to determine the measured value, for example for cHb, to +/- 1 g / dl.
  • a simpler constant calibration (8) is not sufficient to compensate the patient movement so that the measured value for cHb remains accurate to +/- 1 g / dl.
  • the difference in signal quality, between constant calibration and auto-adaptive calibration is 2 g / dl in this embodiment.
  • Fig. 6 shows a typical layer model for illustrating the principles of pulse spectroscopy. Shown is the attenuation of the light intensity by the absorption on the one hand in the non - pulsating tissue part (constant tissue) and the weakening within the pulsating tissue part (pulsatile blood space), which causes the pulsating fluctuation of the exiting light intensity.
  • autoadaptive calibration is used to determine at least one ingredient of body tissue.
  • at least one source of electromagnetic radiation and, spaced from the source of electromagnetic radiation, at least one photoreceiver are arranged adjacent to the body tissue.
  • the source of electromagnetic radiation emits at least two wavelengths selected from a range of 400nm ⁇ 15% / 460 ⁇ 1 ⁇ 15% # 480 ⁇ ⁇
  • Radiation is generated from the source of electromagnetic radiation, which is conducted through the body tissue and hits the photoreceptor after passage through the body.
  • the measurement signals of the photoreceiver are fed to an evaluation device and the evaluation device determines, depending on the number of wavelengths, at least one measured value variable which is indicative of the residual intensity of the radiation after passing through the body tissue.
  • An analyzer fractionates at least two parameters from a measured value variable. meter, wherein at least one parameter represents a variable size of the body tissue at the time of beam passage. Linking the at least one measured value variable with at least one parameter and at least one constant results in the amount of at least one constituent of the body tissue at the time of the beam passage.

Abstract

L'invention concerne un procédé permettant l'étalonnage auto-adaptatif d'au moins une extinction d'au moins un constituant d'un tissu organique. Cette extinction est combinée à au moins une variable de valeur mesurée et/ou au moins un paramètre d'une variable de valeur mesurée et/ou au moins une constante. Le résultat de la combinaison représente la quantité du constituant recherché au moment de la mesure. Cette mesure est effectuée au moyen d'un rayonnement électromagnétique dont la source est placée dans le voisinage du tissu organique. Cette source génère un rayonnement de différentes longueurs d'onde et le rayonnement réfléchi ou transmis par le tissu organique est détecté par un photorécepteur. Les signaux de mesure du photorécepteur sont acheminés vers un dispositif d'évaluation qui détermine au moins une des variables de valeur mesurée en fonction du nombre de longueurs d'onde.
PCT/DE2006/002013 2005-11-15 2006-11-14 Etalonnage auto-adaptatif WO2007056995A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE112006002808T DE112006002808A5 (de) 2005-11-15 2006-11-14 Autoadaptive Kalibration

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102005054835 2005-11-15
DE102005054835.0 2005-11-15

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WO2007056995A1 true WO2007056995A1 (fr) 2007-05-24

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998004903A1 (fr) * 1996-07-26 1998-02-05 Kontron Instruments Ag Procede de determination non invasive de la saturation en oxygene de tissus vascularises
US5772589A (en) * 1995-02-13 1998-06-30 Bernreuter; Peter Measurement process for blood gas analysis sensors
WO2001078593A1 (fr) * 2000-04-17 2001-10-25 Nellcor Puritan Bennett Incorporated Capteur sphygmo-oxymetre avec fonction en pas a pas
WO2002056759A1 (fr) * 2001-01-22 2002-07-25 Datex-Ohmeda, Inc. Compensation de la variabilite humaine en oximetrie pulsee
US20030109776A1 (en) * 1999-07-14 2003-06-12 Providence Health System-Oregon, An Oregon Nonprofit Corporation Adaptive calibration pulsed oximetry method and device
WO2003068060A1 (fr) * 2002-02-15 2003-08-21 Datex-Ohmeda, Inc. Compensation de la variabilite humaine en sphygmo-oxymetrie
US20050168722A1 (en) * 2002-03-27 2005-08-04 Klaus Forstner Device and method for measuring constituents in blood

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5772589A (en) * 1995-02-13 1998-06-30 Bernreuter; Peter Measurement process for blood gas analysis sensors
WO1998004903A1 (fr) * 1996-07-26 1998-02-05 Kontron Instruments Ag Procede de determination non invasive de la saturation en oxygene de tissus vascularises
US20030109776A1 (en) * 1999-07-14 2003-06-12 Providence Health System-Oregon, An Oregon Nonprofit Corporation Adaptive calibration pulsed oximetry method and device
WO2001078593A1 (fr) * 2000-04-17 2001-10-25 Nellcor Puritan Bennett Incorporated Capteur sphygmo-oxymetre avec fonction en pas a pas
WO2002056759A1 (fr) * 2001-01-22 2002-07-25 Datex-Ohmeda, Inc. Compensation de la variabilite humaine en oximetrie pulsee
WO2003068060A1 (fr) * 2002-02-15 2003-08-21 Datex-Ohmeda, Inc. Compensation de la variabilite humaine en sphygmo-oxymetrie
US20050168722A1 (en) * 2002-03-27 2005-08-04 Klaus Forstner Device and method for measuring constituents in blood

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Publication number Publication date
DE102006053975A1 (de) 2007-05-24
DE112006002808A5 (de) 2008-09-04

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