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WO1997013448A2 - Dispositif de dosage de la glycemie - Google Patents

Dispositif de dosage de la glycemie Download PDF

Info

Publication number
WO1997013448A2
WO1997013448A2 PCT/DE1996/001971 DE9601971W WO9713448A2 WO 1997013448 A2 WO1997013448 A2 WO 1997013448A2 DE 9601971 W DE9601971 W DE 9601971W WO 9713448 A2 WO9713448 A2 WO 9713448A2
Authority
WO
WIPO (PCT)
Prior art keywords
eye
radiation
measuring radiation
concentration
light source
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.)
Ceased
Application number
PCT/DE1996/001971
Other languages
German (de)
English (en)
Other versions
WO1997013448A3 (fr
Inventor
Gerhard Müller
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.)
Laser und Medizin Technologie GmbH
Original Assignee
Laser und Medizin Technologie 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 Laser und Medizin Technologie GmbH filed Critical Laser und Medizin Technologie GmbH
Priority to DE29623431U priority Critical patent/DE29623431U1/de
Publication of WO1997013448A2 publication Critical patent/WO1997013448A2/fr
Publication of WO1997013448A3 publication Critical patent/WO1997013448A3/fr
Anticipated expiration legal-status Critical
Ceased 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14558—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters by polarisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/14—Arrangements specially adapted for eye photography
    • A61B3/15—Arrangements specially adapted for eye photography with means for aligning, spacing or blocking spurious reflection ; with means for relaxing
    • 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement

Definitions

  • the invention relates to a device for the non-invasive determination of the concentration of a blood component, in particular for the determination of blood glucose, according to the preamble of claim 1.
  • Devices for determining the blood glucose concentration are known which are based on the influence of the blood glucose concentration on the absorption properties of the human body tissue.
  • the known devices therefore have a light source which shines transcutaneously through a part of the body of the person to be examined, for example the earlobe, the fingertip or the inner lip, at glucose-specific wavelengths in the near infrared or medium infrared, the measuring radiation depending on the blood glucose concentration is weakened.
  • a light detector is therefore arranged on the opposite side of the irradiated body part, which detects the transmitted measuring radiation and feeds a corresponding signal to an evaluation unit which uses it to calculate the blood glucose concentration.
  • the problem here is that the blood glucose-specific signal is extremely small compared to underground signals due to water and tissue absorption.
  • the high value of the water absorption changes depending on the temperature, so that practically no meaningful measurement signal can be obtained.
  • Another disadvantage of these devices is that both the so-called tissue glucose concentration and the blood glucose concentration are measured simultaneously and there is practically no possibility of differentiating the two signals. Beyond that Such measurements are falsified in that the light propagation in the tissue is not adequately taken into account as a multiple scattering process.
  • devices for determining blood glucose which are based on the determination of the optical activity, that is to say the change in the direction of polarization by the right-handed glucose, of the irradiated tissue.
  • These devices also have the disadvantage that the propagation of light in the tissue is not adequately taken into account.
  • the optical activity of the irradiated tissue depends not only on the blood glucose concentration, but is also influenced by the concentration of other optically active blood or tissue components.
  • a further disadvantage of these devices is the extreme dependence of the measurement result on the irradiated layer thickness, which must therefore also be determined, which is not possible or is only possible with increased technical effort.
  • the invention is therefore based on the object of creating a device for non-invasive blood glucose determination which enables simple and accurate measurement of the blood glucose concentration and avoids the above-mentioned disadvantages of the known devices.
  • the invention includes the technical teaching of introducing measuring radiation into the anterior chamber of an eye of the test person by means of a light source in order to determine the concentration of a blood component and the intensity of the reflected or backscattered measurement radiation to be detected by a light detector in order to determine the blood concentration of the respective blood component from the concentration-dependent intensity of the reflected or backscattered measurement radiation.
  • this is based on the new and surprising finding that the fluid in the anterior chamber of the human eye is to be regarded as the ultrafiltrate of the blood plasma and therefore has a strict correlation with a glucose content which corresponds to that of the blood plasma.
  • the invention is not limited to determining the blood glucose concentration, but rather can be used to measure the concentration of all blood components in which the concentration in the eye fluid has a predetermined dependence on the blood concentration.
  • the invention is also not limited to humans as a measurement object, but can also be used with animals.
  • a measurement light to be introduced into the anterior chamber by means of a first light source, the wavelength of the measurement radiation for exciting glucose-specific Raman bands preferably being in the near infrared range.
  • emission wavelengths in the range from 650 nm to 2.5 ⁇ m have proven to be advantageous.
  • a light detector is provided, which is arranged in front of the irradiated eye for measuring the measurement radiation reflected or backscattered in the eye fluid.
  • the concentration of the respective blood component is then determined by an evaluation unit which is connected on the input side to the light detector.
  • the evaluation unit preferably subjects the reflected or backscattered measurement radiation to Fourier transform infrared Raman spectroscopy in order to be able to subsequently calculate the blood concentration sought from the spectral intensity distribution.
  • focusing optics are provided which focus the measuring radiation generated by the first light source in the anterior chamber in such a way that the measuring radiation essentially hits the iris diaphragm on the retina side, thereby preventing damage to the retina even at high intensities of the measuring radiation .
  • This focusing optics preferably has a high-aperture, short focal length dark field objective, as is known, for example, from light microscopy.
  • the dark field lens is arranged in front of the subject's eye, the excitation radiation being focused radially symmetrically into the anterior chamber of the eye.
  • the light-filled double cone is focused in such a way that it is already so divergent in the retinal focus area that it does not fall through the pupil onto the retina, but is stopped by the iris diaphragm.
  • a wavelength in the range of strong absorption of water to prevent retina damage by the measuring radiation.
  • This is for protection No separate optics are required for the retina before the measuring radiation, since the measuring radiation is sufficiently attenuated until the retina is reached due to absorption by the eye fluid in order to prevent damage to the retina. Wavelengths above 1.5 ⁇ m have proven to be advantageous.
  • the detection of the reflected or backscattered measurement radiation is then carried out - as already described above - by a light detector and a downstream evaluation unit, preferably using the technologies of the so-called Fourier transform infrared Raman spectroscopy.
  • a further variant of the invention provides for the examined eye to be fixed during the measurement. This is particularly advantageous if, as already described above, a focus is used to prevent the retina from being damaged by the measuring radiation ⁇ rungsoptik is provided, which generates a strongly divergent beam on the retina side, since the effectiveness of such focusing optics is only fully available with a certain spatial position of the eye and decreases when the viewing direction changes.
  • the eye is fixed in that a fixation mark is faded into the field of vision, which is fixed by the test subject and causes the eyes to be immobilized in a defined position.
  • the fixation mark is generated by a second light source with an emission wavelength in the visible wavelength range, the light exit opening of which is arranged spatially fixed in the field of view of the subject.
  • An optical waveguide, one end of which is connected to the second light source, is particularly advantageous for this purpose, while the light outlet opening is arranged in the field of view of the examined eye.
  • an optical filter is provided between the light detector and the examined eye in the beam path of the reflected measuring radiation, which suppresses light in those wavelength ranges in which the intensity of the backscattered or reflected measuring radiation is only slight Depends on the concentration of the blood component to be determined.
  • the proportion of measuring radiation that reaches the light detector has a significantly greater dependence on the concentration to be determined, which simplifies the measurement and increases the accuracy.
  • FIG. 1 shows, as a preferred embodiment of the invention, a device for determining the blood glucose concentration with an illustration of the beam paths
  • Figure 2 shows the arrangement of the device of Figure 1 during the measurement
  • Figure 3 shows an alternative embodiment of the device according to the invention.
  • the device shown in Figure 1 enables a non-invasive determination of the blood glucose concentration by Introducing measuring radiation into the front chamber 1 of an eye 2 and measuring the backscattered or reflected portion.
  • the measuring radiation is generated by a light source 3 and brought to the required beam cross-section by an expansion optics 4.
  • the measuring radiation is then directed with a ring-shaped mirror 5 onto a dark field illumination objective 6, which focuses the measuring radiation in the front chamber 1 of the eye 2 in such a way that after passing through the focal point it falls on the iris diaphragm 7 and thus the sensitive retina behind the Eye lens 8 not at risk.
  • the differently strong Raman radiation which arises in the front chamber 1, depending on the glucose concentration, is bundled by the high-aperture lens 9 and, before it reaches the light detector 10, sent through a filter 11 which suppresses the interfering radiation components.
  • the evaluation unit 12 which first subjects the output signal of the light detector 10 to Fourier transform infrared Raman spectroscopy and calculates the blood glucose concentration from the spectral intensity distribution using a computing unit.
  • the device shown enables the eye 2 to be fixed and the iris 7 to be narrowed in order to prevent damage to the sensitive retina by the measurement radiation.
  • a fixation mark is faded into the field of vision, which is fixed by the test subject, which on the one hand leads to a fixation of the eye 2 and, on the other hand, to a narrowing of the iris diaphragm 7 due to the brightness of the fixation mark, since the eye 2 independently adjusts to the lighting conditions adjusts.
  • the fixing mark is generated by a second light source designed as a fixing mark projector and is faded into the field of view via a light waveguide 13.
  • the light exit opening of the optical waveguide 13 is arranged in front of the high-aperture lens 9 in such a way that the fixation mark only fully reaches the retina when the eye 2 is in the most favorable measuring position.
  • FIG. 2 shows, on the one hand, the arrangement of the device shown only schematically above in a binocular viewing device 14 and, on the other hand, the use of the binocular viewing device 14 by the person 15 to be examined.
  • the device described above is arranged in the tube 16.1 of the binocular viewing device 14, which is placed on the right eye of the subject 15 with an eyepiece 17.1.
  • the other tube 16.2 contains a display 18 which is arranged at the transition point to the associated eyepiece 17.2.
  • This display 18 is controlled by the evaluation unit and shows the measured blood glucose concentration, so that the person 15 to be examined only has to look into the binocular vision device 14 and the blood glucose concentration is immediately displayed.
  • the device according to the invention is thus easy to handle that a diabetic can determine the blood glucose value in a self-test.
  • FIG. 3 finally shows an alternative embodiment of the device according to the invention for determining the blood glucose concentration, measuring radiation being introduced into the front chamber 1 of an eye 2 as in the exemplary embodiment shown in FIG. 1, and the proportion of the reflected or backscattered measuring radiation is measured.
  • the measuring radiation is generated here by a light source 19, the emission wavelength of which is above 1.5 ⁇ m, so that the measuring radiation is strongly absorbed by the eye fluid, which essentially consists of water.
  • a light source 19 the emission wavelength of which is above 1.5 ⁇ m, so that the measuring radiation is strongly absorbed by the eye fluid, which essentially consists of water.
  • This advantageously prevents damage to the sensitive retina from the measuring radiation, since the measuring radiation is sufficiently attenuated after it has passed through the interior of the eye until the eye fluid reaches the retina to prevent damage to the retina.
  • the embodiment shown therefore does not require separate focusing optics in order to prevent direct exposure of the retina.
  • the measuring radiation generated by the light source 19 is faded into the field of view of the eye 2 via the colimation lens 20 and the partially transparent mirror 21 and is focused by the focusing lens 22 in the front chamber 1 of the eye 2.
  • the Raman radiation which is dependent on the glucose concentration, is collected by the high-aperture focusing lens 22 and penetrates the partially transparent mirror 21, which has a high degree of transparency for the spectral intensity distribution of the Raman radiation. Then reached the reflected measuring radiation the light detector 23, which is connected on the output side to the evaluation unit 24.
  • the measurement radiation is first subjected to a Fourier transform Raman spectroscopy by the evaluation unit 24, in order then to be able to calculate the blood glucose concentration as a function of the determined spectrum of the Raman radiation.
  • the embodiment of the invention is not limited to the preferred exemplary embodiments specified above. Rather, a number of variants are conceivable which make use of the solution shown, even in the case of fundamentally different types.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Optics & Photonics (AREA)
  • Pathology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Emergency Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Dispositif de dosage de la glycémie comprenant une source de lumière (3) pour la production d'un rayonnement de mesure destiné à irradier une partie (2) du corps à une longueur d'onde à laquelle les caractéristiques optiques de la partie du corps (2) dépendent de la concentration du constituant sanguin en question, un photodétecteur (10) pour la détection du rayonnement de mesure atténué dans ladite partie (2) du corps en fonction de la concentration, ainsi qu'une unité d'évaluation (12) pour l'évaluation de la concentration dudit constituant sanguin en fonction du rayonnement de mesure détecté, la partie du corps (2) irradiée étant un oeil (2) et le photodétecteur (10) pour la mesure de la réflexion du faisceau lumineux étant placé dans la trajectoire du rayonnement réfléchi ou rétrodiffusé dans la chambre antérieure (1) de l'oeil. Un système de focalisation (6) est monté entre la source de lumière (3) et l'oeil (2) irradié pour empêcher que la rétine ne soit endommagée par le rayonnement de mesure. Ce système de focalisation concentre ledit rayonnement de mesure dans la chambre antérieure (1) de l'oeil, de sorte que le rayonnement du côté de la rétine soit arrêté essentiellement par l'iris (7) et/ou que la longueur d'onde dudit rayonnement se trouve dans la plage d'absorption de l'humeur aqueuse afin que la rétine ne soit pas endommagée par celui-ci.
PCT/DE1996/001971 1995-10-14 1996-10-14 Dispositif de dosage de la glycemie Ceased WO1997013448A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE29623431U DE29623431U1 (de) 1995-10-14 1996-10-14 Vorrichtung zur Blutglucosebestimmung

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE1995138372 DE19538372A1 (de) 1995-10-14 1995-10-14 Nicht invasive Glukosemessung
DE19538372.9 1995-10-14

Publications (2)

Publication Number Publication Date
WO1997013448A2 true WO1997013448A2 (fr) 1997-04-17
WO1997013448A3 WO1997013448A3 (fr) 1997-05-29

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Application Number Title Priority Date Filing Date
PCT/DE1996/001971 Ceased WO1997013448A2 (fr) 1995-10-14 1996-10-14 Dispositif de dosage de la glycemie

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DE (2) DE19538372A1 (fr)
WO (1) WO1997013448A2 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6044285A (en) * 1997-11-12 2000-03-28 Lightouch Medical, Inc. Method for non-invasive measurement of an analyte
US6289230B1 (en) 1998-07-07 2001-09-11 Lightouch Medical, Inc. Tissue modulation process for quantitative noninvasive in vivo spectroscopic analysis of tissues
US7769419B2 (en) 2003-10-24 2010-08-03 Lein Applied Diagnostics Limited Ocular property measuring apparatus and method therefor
US8078245B2 (en) 2003-12-12 2011-12-13 Lein Applied Diagnostics Limited Extended focal region measuring apparatus and method
US8696128B2 (en) 2007-07-30 2014-04-15 Lein Applied Diagnostics Optical measurement apparatus and method therefor
US9026188B2 (en) 2008-02-11 2015-05-05 Lein Applied Diagnostics Measurement apparatus and method therefor
CN106466185A (zh) * 2015-08-18 2017-03-01 富士施乐株式会社 光学测量装置及光照射接收方法
WO2018083112A1 (fr) * 2016-11-01 2018-05-11 Universiteit Maastricht Dispositif d'exécution de mesures de la composition chimique de l'œil antérieur ainsi qu'une unité optique intégrée pour sa mise en œuvre

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6494576B1 (en) 1999-09-30 2002-12-17 L'esperance, Jr. Francis A. Method and apparatus for spectrophotometry of the eye
DE10027100C2 (de) 2000-05-31 2002-08-08 Klaus Mueller-Dethlefs Verfahren und Vorrichtung zum Nachweisen von Substanzen in Körperflüssigkeiten
US6968222B2 (en) 2003-05-02 2005-11-22 Oculir, Inc. Methods and device for non-invasive analyte measurement
US6958039B2 (en) 2003-05-02 2005-10-25 Oculir, Inc. Method and instruments for non-invasive analyte measurement
US6975892B2 (en) 2003-10-21 2005-12-13 Oculir, Inc. Methods for non-invasive analyte measurement from the conjunctiva

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3963019A (en) * 1974-11-25 1976-06-15 Quandt Robert S Ocular testing method and apparatus
DE3540916A1 (de) * 1985-11-19 1987-05-21 Zeiss Carl Fa Verfahren und vorrichtung zur raster-lichtmikroskopischen darstellung von objekten im dunkelfeld
US4756305A (en) * 1986-09-23 1988-07-12 Mateik William J Eye training device
US5243983A (en) * 1990-12-14 1993-09-14 Georgia Tech Research Corporation Non-invasive blood glucose measurement system and method using stimulated raman spectroscopy
US5203328A (en) * 1991-07-17 1993-04-20 Georgia Tech Research Corporation Apparatus and methods for quantitatively measuring molecular changes in the ocular lens
JPH07508426A (ja) * 1991-10-17 1995-09-21 サイエンティフィック　ジェネリクス　リミテッド 血液検体測定装置及びその方法
US5433197A (en) * 1992-09-04 1995-07-18 Stark; Edward W. Non-invasive glucose measurement method and apparatus
DE4243142A1 (de) * 1992-12-19 1994-06-23 Boehringer Mannheim Gmbh Vorrichtung zur in-vivo-Bestimmung einer optischen Eigenschaft des Kammerwassers des Auges

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6044285A (en) * 1997-11-12 2000-03-28 Lightouch Medical, Inc. Method for non-invasive measurement of an analyte
US6377828B1 (en) 1997-11-12 2002-04-23 Lightouch Medical, Inc. Method for non-invasive measurement of an analyte
US6289230B1 (en) 1998-07-07 2001-09-11 Lightouch Medical, Inc. Tissue modulation process for quantitative noninvasive in vivo spectroscopic analysis of tissues
US7769419B2 (en) 2003-10-24 2010-08-03 Lein Applied Diagnostics Limited Ocular property measuring apparatus and method therefor
US8078245B2 (en) 2003-12-12 2011-12-13 Lein Applied Diagnostics Limited Extended focal region measuring apparatus and method
US8696128B2 (en) 2007-07-30 2014-04-15 Lein Applied Diagnostics Optical measurement apparatus and method therefor
US9026188B2 (en) 2008-02-11 2015-05-05 Lein Applied Diagnostics Measurement apparatus and method therefor
CN106466185A (zh) * 2015-08-18 2017-03-01 富士施乐株式会社 光学测量装置及光照射接收方法
WO2018083112A1 (fr) * 2016-11-01 2018-05-11 Universiteit Maastricht Dispositif d'exécution de mesures de la composition chimique de l'œil antérieur ainsi qu'une unité optique intégrée pour sa mise en œuvre

Also Published As

Publication number Publication date
WO1997013448A3 (fr) 1997-05-29
DE19538372A1 (de) 1997-04-17
DE29623431U1 (de) 1998-07-02

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