EP1365681A2 - Procede de determination d'un parametre de transport de lumiere dans une matrice biologique - Google Patents

Procede de determination d'un parametre de transport de lumiere dans une matrice biologique

Info

Publication number
EP1365681A2
EP1365681A2 EP02719907A EP02719907A EP1365681A2 EP 1365681 A2 EP1365681 A2 EP 1365681A2 EP 02719907 A EP02719907 A EP 02719907A EP 02719907 A EP02719907 A EP 02719907A EP 1365681 A2 EP1365681 A2 EP 1365681A2
Authority
EP
European Patent Office
Prior art keywords
light
biological matrix
detection
intensity
measuring distances
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP02719907A
Other languages
German (de)
English (en)
Inventor
Uwe Kraemer
Heinz-Michael Hein
Dietmar Volz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Original Assignee
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Boehringer Mannheim GmbH
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 F Hoffmann La Roche AG, Roche Diagnostics GmbH, Boehringer Mannheim GmbH filed Critical F Hoffmann La Roche AG
Publication of EP1365681A2 publication Critical patent/EP1365681A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • 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
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0233—Special features of optical sensors or probes classified in A61B5/00
    • A61B2562/0242—Special features of optical sensors or probes classified in A61B5/00 for varying or adjusting the optical path length in the tissue
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/14—Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
    • Y10T436/142222—Hetero-O [e.g., ascorbic acid, etc.]
    • Y10T436/143333—Saccharide [e.g., DNA, etc.]
    • Y10T436/144444—Glucose

Definitions

  • the invention relates to a method for the selective determination of a light transport parameter which is characteristic of light scattering in a biological matrix, in particular for the purpose of the non-invasive determination of the concentration of glucose in the biological matrix.
  • biological matrix denotes a body fluid or a tissue of a living organism.
  • Biological matrices to which the invention relates are optically heterogeneous, ie they contain a large number of scattering centers, at which incident light is scattered.
  • the scattering centers are formed by the cell walls and other solid components contained in the tissue.
  • Body fluids, especially blood, are also optically heterogeneous biological matrices because they contain particles on which light is scattered in many ways.
  • the transport of light in a biological matrix is essentially determined by the light scattering at scattering centers contained in the matrix and by the optical absorption. Physical quantities that describe these two properties quantitatively are referred to as light transport parameters (scattering parameters or absorption parameters).
  • the scattering coefficient ⁇ s is primarily used as the scattering parameter and the optical absorption coefficient ⁇ a is primarily used as the absorption parameter.
  • these parameters it is not necessary in the context of the invention for these parameters to be determined quantitatively in the customary units of measurement. Rather, the aim of the invention is to reproducibly and selectively determine a parameter that describes the optical scattering in the biological sample regardless of its optical absorption.
  • the scattering coefficient ⁇ s as an example of a scattering parameter without restricting generality.
  • the selective determination of the scattering coefficient in a biological matrix is of interest for various reasons, for example to characterize skin properties in dermatology.
  • a plurality of “detection measurements” are carried out to determine a glucose value, in each of which light is irradiated as primary light at a defined irradiation location in the biological matrix, the light in the biological matrix along a light path propagated and an intensity measurement of secondary light emerging at a defined detection location is measured.
  • the glucose concentration is determined in an evaluation step by means of an evaluation algorithm and a calibration from the dependence of the intensity measurement value on the measurement distance between the respective irradiation location and the respective detection location.
  • the influences of absorption and scatter are to be separated in the evaluation step by evaluating the intensity distribution of the secondary light as a function of the distance of the detection location from the radiation location.
  • TJ Farrell et al. "A diffusion theory odel of spatially resolved, steady-state diffuse reflectance for the noninvasive determination of tissue optical properties in vivo", Med. Phys. 1_9, 879 to 888 (1992) 2) RC Haskeil et al. : “Boundary conditions for the diffusion equation in radiative transfer", J. Opt.Soc.Am ⁇ , 11.2727 'to 2741 (1994).
  • At least two frequency domain spectroscopic measurements are carried out for at least two different measurement light paths, in each of which the phase shift of the secondary light relative to the primary light and an intensity measurement value (namely the DC intensity or the AC intensity) are determined , An absorption parameter and / or a scattering parameter are derived from these at least four measured values.
  • Frequency domain measurement methods work with light modulated in the GHz range and therefore require a great deal of measurement technology.
  • EP 0774658 A2 describes a method in which the reflection properties on the surface of the matrix are varied in order to analyze the scattering properties of a biological matrix.
  • the contact surface of the device used for the measurement th measuring head have different sub-areas with different reflectivity.
  • the reflection properties are varied at least twice with two measuring distances.
  • the publication states that these at least four measured values can be used to separate absorption and scattering (either on the basis of diffusion theory or empirically and numerically).
  • this method is also relatively complex.
  • the invention is based on the object of selectively determining in a biological matrix ⁇ s (or another parameter describing light scattering) using a method which is distinguished by simple handling, low expenditure on equipment and high accuracy.
  • a method for selectively determining a light transport parameter which is characteristic of light scattering in a biological matrix comprising a plurality of detection measurements, each of which involves light is irradiated into the biological matrix as primary light at an irradiation location, the light propagates in the biological matrix along a light path and an intensity measurement value of secondary light emerging at a detection location which is located at the plurality of detection measurements at different measuring distances from the irradiation location is measured and an evaluation step in which the characteristic of light scattering in the biological matrix tical light transport parameters are derived by means of an evaluation algorithm from the intensity measurement values measured in the plurality of detection measurements, which is characterized in that the evaluation algorithm includes a step in which a time derivative value ⁇ describing the temporal change in the intensity measurement value describes the change in intensity measurement value from at least two times ⁇ I (r) is calculated and the time derivative value is used to determine the light transport parameter.
  • the measurement of the intensity measurement value is preferably a DC measurement, in which primary light is irradiated with constant intensity.
  • chopped or intensity-modulated primary light and a frequency-selective measurement method can also be used.
  • a frequency-modulated method leads to the measurement of the AC intensity. Such a method is currently less preferred because of the increased measuring effort at very high measuring frequencies.
  • the intensity of the secondary light does not have to be measured absolutely in the context of the invention. Rather, a relative measurement at at least two measuring times is sufficient, from which a time derivative value can be calculated.
  • An intensity measurement value in the sense of the invention is therefore a value of a measurement variable in arbitrary units of measurement, which allows a statement about the relative change in the intensity of the secondary light.
  • Such an intensity measurement value for a time t and a measurement distance r is referred to below as I (r, t).
  • time derivative value (the relative change over time for a agreed measuring distance r measured intensity measurement value) of the partial derivation of the function I (r, t) over time
  • the intensity is measured at at least two discrete measuring times tj_.
  • the time derivative value is then calculated as the difference quotient according to
  • the invention requires at least two detection measurements at two different measuring times t for a fixed measuring distance r 0 .
  • intensity measurement values are preferably measured for several different measurement distances (intensity profiles).
  • the sensitivity of the Intensity profile I (r) with regard to the parameter Pj . which is calculated according to:
  • this mathematical relationship means that the time derivative value describing the relative temporal change in the intensity profile is an intermediate value which makes it possible in a very advantageous manner to separate the influences of the different model parameters from one another and thereby selectively determine the scattering coefficient.
  • the time derivative value is not calculated in order to obtain information about the change over time in the scattering coefficient or the glucose concentration. Rather, the time derivative value represents an intermediate value within the algorithm for determining the scattering coefficient or. represents the glucose concentration. It can be used directly, for example to eliminate a parameter whose sensitivity curve is known as a function of the measuring distance.
  • the value calculated on the basis of this time derivative value (e.g. the scattering coefficient or the glucose concentration) is assigned to the mean point in time of the detection measurements from which the time derivative value was calculated.
  • the evaluation algorithm includes steps in which detection measurements are carried out at least two times for at least two different measuring distances between the irradiation site and the detection site.
  • the (at least four) intensity measurement values measured in the process become calculates at least two time derivative values, from which in turn the spatial derivative of the time derivative value is calculated according to the measuring distance.
  • the result of these operations is independent of fluctuations in the primary light intensity I 0 . Fluctuations in the light source intensity, which cause a so-called "co mon mode drift" in the signal, are consequently eliminated from the measurement result.
  • the evaluation algorithm contains steps in which detection measurements are carried out for at least three different measuring distances between the irradiation site and the detection site at at least two times in each case. At least three time derivative values are calculated from the (at least six) intensity measurement values obtained. These time derivative values are calculated.
  • the second spatial derivative corresponds to the curvature of the function d t I (r).
  • the measurement result obtained is essentially independent of the absorption coefficient ⁇ a .
  • the sensitivity S ⁇ (r) calculated according to equation (4) is a linear function of r.
  • the second derivative of a linear function is N ull.
  • the detection measurements which are used in the algorithm explained above are preferably carried out with unusually short measuring intervals. • are preferably from the measurement distances of the two or three detection measurements
  • the detection measurements are carried out with a measuring distance that is smaller than the mean free path length.
  • the mean free path in the uppermost layers of human skin is approximately 0.7 mm. It follows from this that all measuring distances for measurements on the skin used in the context of the invention are preferably below 3 mm and particularly preferably below 2 mm. These short measuring distances allow a very compact design of the measuring head. For this reason, the invention is very well suited for medical diagnostics, including endoscopic examinations, of tissue.
  • FIG. 1 shows a schematic cross-sectional representation of a device for the optical analysis of a biological matrix
  • FIG. 2 shows a first plot of a course of the glucose concentration in the body of a subject measured according to the invention in comparison with measurement results obtained conventionally invasively
  • FIG. 3 shows a plot corresponding to FIG. 2, but with different measuring distances
  • FIG. 4 shows a plot corresponding to FIG. 2, but with yet another measuring distance
  • FIG. 5 shows a plot similar to FIG. 2, in which a conventionally invasively measured course of the glucose concentration with the measurement results of a previously known non-invasive method based on diffusion theory is compared,
  • the device for the selective determination of ⁇ s in a biological matrix which is shown in a highly schematic form in FIG. 1, essentially consists of a measuring head 1 and a signal processing and evaluation unit 2.
  • the measuring head 1 lies with the underside of a sample contact plate 3 on an interface 4 of the biological matrix 5 to be examined, which contains a multiplicity of scattering centers 6. Inside the measuring head 1 there are light irradiation means 7, which in the illustrated case are formed by a light-emitting diode 8 and serve to radiate primary light (arrow 9) into the biological matrix 5.
  • the irradiation location 10 of the primary light is defined by a corresponding recess in the skin contact plate 3.
  • the detection means 16 include optical fibers 17, by means of which the secondary light from all three detection locations is fed to a common photo receiver 18 (for example a photo diode, in particular avalanche photo diode 18). leads.
  • the optical fibers 17 contain optical switches (not shown).
  • the light paths along which the light radiated into the biological matrix 5 propagates between the irradiation site 11 and the detection site 12 to 14 are shown symbolically in FIG. 1 and designated 20 to 22.
  • no sharply delimited light paths can be specified.
  • most of the photons detected as secondary light propagate approximately on a curved light path - similar to that shown - the mean penetration depth increasing with the size of the measuring distance r between the irradiation site 10 and the detection site 12 to 14.
  • the output signal of the photo receiver is fed to signal processing electronics 25 via a cable 24. There it is amplified, processed and digitized in the usual way, so that intensity measurements are available at its output in digital form which correspond to the intensity of the secondary light emerging at the detection locations 13 to 15.
  • Both the irradiation means and the detection means' can be implemented in the form of light transmitters or light-sensitive elements integrated directly into the sample contact plate 3 or with the aid of optical fibers which guide the light from a more distant light transmitter to the skin contact plate 3 or from the latter to one Transport the light receiver.
  • the different measuring Distances can be realized by different combinations of irradiation and detection locations.
  • the three measuring distances ri, r 2 and r 3 shown in FIG. 1 can also be realized by irradiating at three different irradiation sites and measuring at one detection site.
  • the measuring head 1 and the signal processing electronics 25 are in any case designed in such a way that the signal processing electronics 25 measure intensity values for each desired measurement time and for those at the respective time
  • Measuring head possible measuring distances (in the case shown, the measuring distances ri, r 2 and r 3 ) are determined and forwarded in digital form to the evaluation electronics 26.
  • a time derivative value is calculated from at least two intensity measurement values measured at different times (equation 2) and these are used to determine the light transport parameter.
  • a healthy male test subject was given a glucose drink orally, which caused his blood glucose value to increase by 130 mg / dl (from 80 mg / dl to 210 mg / dl). The glucose value then fell back to the normal value of 80 mg / dl.
  • a measuring head with an irradiation location (circular point, 0.1 mm diameter) and six detection locations (each in the form of a segment of a circle with an opening angle of 30 °) was fixed on the skin on the belly of this subject. The skin contact plate of the head and thus the skin was heated to a temperature of 33.5 ° C.
  • the potential in the measuring head distances between the irradiation site and the detection site were 0.8 mm, 1.2 mm, 1/6 mm, 2.0 mm, 2.4 mm and 2.8 mm.
  • the primary light was irradiated with a wavelength of 805 nm.
  • the measured intensity measurement values I (r, t) were evaluated using the following algorithm:
  • time derivative values A t I (r) were calculated according to equation (2) for three measuring distances r.
  • the second spatial derivative of the time derivative value after the measuring distance was calculated from these time derivative values in accordance with:
  • FIGS. 2 to 4 The results are shown in FIGS. 2 to 4 as a measurement curve NI, namely FIG. 2 for the measurement distance triple a, FIG. 3 for the measurement distance triple b and FIG. 4 for the measurement distance triple c.
  • the curve NI in each case denotes the result of the evaluation algorithm.
  • the thicker curve I represents a comparative measurement in which the concentration C G of glucose in the blood was determined invasively in a conventional manner. Both curves were normalized at one point. This corresponds to a calibration of the non-invasively measured glucose profile NI according to the invention by means of a single invasive control measurement.
  • the basis of the evaluation can be used, a very good non-invasive control of the time course of the blood sugar level is made possible in a simple manner.
  • FIG. 5 shows the results of a comparison test in which the same intensity measurement values were evaluated using an algorithm according to the prior art.
  • the measured intensity profile (using all measuring distances between 0.8 mm and 2.4 mm) was fitted to a model calculated using the diffusion theory.
  • the result of the non-invasive measurement is denoted by NI, one point being normalized to the conventionally measured measurement curve I, which is also entered. It should be noted that there is no acceptable correlation between the calculated results of the non-invasive measurement and the actual glucose variation.
  • the invention differs fundamentally from previously known methods based on diffusion theory, in which - as in the publications 1) and 2) cited in the introduction - relatively large measuring distances are used for the evaluation. This is also reflected in the publication
  • the inventors calculated scatter sensitivities S ⁇ according to equation (4) on the basis of diffusion theory.
  • the functional dependence shown in FIG. 6 of the second spatial derivative of the scatter sensitivity A r 2 S ⁇ results as a function of the measuring distance (r in mm ).
  • FIG. 7 shows the second spatial derivative of the ratio of the scattering sensitivity S ⁇ to the absorption sensitivity S ⁇ as a function of the measuring distance r and the distance d between the detection sites in mm. From this graphic representation it can be seen that the ratio between S ⁇ and S ⁇ increases for small measuring distances. This also confirms the experimental results.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
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  • Molecular Biology (AREA)
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  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Emergency Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un procédé de détermination sélective d'un paramètre de transport de lumière caractéristique de la diffusion de la lumière dans une matrice biologique (5), en particulier pour la détermination non invasive de la concentration de glucose dans ladite matrice biologique. Ce procédé consiste à effectuer plusieurs mesures de détection, lors desquelles on injecte de la lumière en tant que lumière primaire dans la matrice biologique et on mesure une valeur d'intensité d'une lumière secondaire apparaissant sur un lieu de détection situé à différentes distances de mesure du lieu d'injection de lumière, lors des diverses mesures de détection. Dans une étape d'évaluation, on dérive à partir des valeurs d'intensité mesurées le paramètre de transport de lumière caractérisant la diffusion de la lumière dans la matrice biologique, au moyen d'un algorithme d'évaluation. Selon la présente invention, cet algorithme d'évaluation, qui sert à la détermination sélective du coefficient de dispersion, comprend une étape, dans laquelle une valeur DELTA tI(r) décrivant la modification temporelle de la valeur d'intensité mesurée est calculée à partir d'au moins deux valeurs d'intensité mesurées à différentes périodes.
EP02719907A 2001-03-06 2002-02-23 Procede de determination d'un parametre de transport de lumiere dans une matrice biologique Withdrawn EP1365681A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10110599A DE10110599A1 (de) 2001-03-06 2001-03-06 Verfahren zur Bestimmung eines Lichttransportparameters in einer biologischen Matrix
DE10110599 2001-03-06
PCT/EP2002/001944 WO2002069790A2 (fr) 2001-03-06 2002-02-23 Procede de determination d'un parametre de transport de lumiere dans une matrice biologique

Publications (1)

Publication Number Publication Date
EP1365681A2 true EP1365681A2 (fr) 2003-12-03

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EP02719907A Withdrawn EP1365681A2 (fr) 2001-03-06 2002-02-23 Procede de determination d'un parametre de transport de lumiere dans une matrice biologique

Country Status (5)

Country Link
US (1) US7565249B2 (fr)
EP (1) EP1365681A2 (fr)
AU (1) AU2002251002A1 (fr)
DE (1) DE10110599A1 (fr)
WO (1) WO2002069790A2 (fr)

Families Citing this family (4)

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Publication number Priority date Publication date Assignee Title
DE10163972B4 (de) 2001-12-22 2005-10-27 Roche Diagnostics Gmbh Verfahren und Vorrichtung zur Bestimmung eines Lichttransportparameters und eines Analyten in einer biologischen Matrix
JP2013103094A (ja) * 2011-11-16 2013-05-30 Sony Corp 測定装置、測定方法、プログラム及び記録媒体
US10485461B2 (en) 2016-07-29 2019-11-26 Samsung Electronics Co., Ltd. Apparatus and method for estimating substance in blood
WO2023210521A1 (fr) * 2022-04-27 2023-11-02 国立研究開発法人産業技術総合研究所 Dispositif et procédé de mesure de valeur de caractéristique optique

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US5782755A (en) * 1993-11-15 1998-07-21 Non-Invasive Technology, Inc. Monitoring one or more solutes in a biological system using optical techniques

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US551422A (en) * 1895-12-17 Churn
IL107396A (en) 1992-11-09 1997-02-18 Boehringer Mannheim Gmbh Method and apparatus for analytical determination of glucose in a biological matrix
DE4337570A1 (de) * 1993-11-04 1995-05-11 Boehringer Mannheim Gmbh Verfahren zur Analyse von Glucose in einer biologischen Matrix
WO1995032416A1 (fr) * 1994-05-19 1995-11-30 Boehringer Mannheim Gmbh Procede et dispositif pour la determination d'un analyte dans un echantillon biologique
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Also Published As

Publication number Publication date
WO2002069790A2 (fr) 2002-09-12
US7565249B2 (en) 2009-07-21
AU2002251002A1 (en) 2002-09-19
DE10110599A1 (de) 2002-09-12
WO2002069790A3 (fr) 2002-12-27
US20040152089A1 (en) 2004-08-05

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