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WO2002003855A1 - Dispositif optique de mesure d'analysats dans des larmes - Google Patents

Dispositif optique de mesure d'analysats dans des larmes Download PDF

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Publication number
WO2002003855A1
WO2002003855A1 PCT/GB2001/003078 GB0103078W WO0203855A1 WO 2002003855 A1 WO2002003855 A1 WO 2002003855A1 GB 0103078 W GB0103078 W GB 0103078W WO 0203855 A1 WO0203855 A1 WO 0203855A1
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WO
WIPO (PCT)
Prior art keywords
assay
analyte
binding
eyelid
glucose
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/GB2001/003078
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English (en)
Inventor
Christopher John Stanley
Anders Weber
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Individual
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to AU2001270774A priority Critical patent/AU2001270774A1/en
Publication of WO2002003855A1 publication Critical patent/WO2002003855A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/411—Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance

Definitions

  • EP-A-603658 describes a technique for determination of the glucose concentration in the aqueous humour of the eye using polarimetry. Again this technique is minimally invasive but has proven to be of limited value because of its low sensitivity.
  • Lachrymal fluid is thus a good target for non-invasive glucose measurement.
  • Current techniques for measuring glucose in lachrymal fluid include the use of basic colorimetric test strips which are wetted by tears, either directly or with the use of an absorbent wick, and then inspected for a colour change (described in EP-A- 236023 and US-A-5352411) .
  • Japanese Patent Application No. JP-A-05093723 describes a device constructed of a ⁇ plastics material' which is fitted to the eyeball and is equipped with an electrochemical system using an enzyme based sensor for measuring analytes, such as glucose or lactate, in the lachrymal fluid.
  • WO 01/13783 describes the use of an ophthalmic lens comprising a receptor moiety which can be used to determine the amount of an analyte in an ocular fluid.
  • the ophthalmic lens can be a full size contact lens, a permanently implanted lens of the intraocular, intracorneal or subconjunctival type or a shunt or implant in the cul de sac of the eye.
  • Ophthalmic lenses can be corrective or they may not affect visual acuity, the lenses must also be accessible to light.
  • the examples indicate that the lenses are illuminated through the pupil of the eye; no indication is given as to how a signal can be obtained from ophthalmic lenses that are accessed through other routes. Permanently implanted lenses are not ideal for a sensing application as the sensor components only have a limited lifetime.
  • the present invention provides a device which avoids the disadvantages of the prior art. Accordingly, in a first aspect the present invention provides a device for the detection or quantitative measurement of an analyte in lachrymal fluid, the device being locatable on the surface of the eyeball in contact with lachrymal fluid and incorporating an assay for said analyte, the readout of which assay is a detectable or measurable optical signal which can be interrogated remotely using optical means.
  • the device of the present invention has the advantages of reliability and accuracy of glucose measurement, safety, convenience and ease of use. With particular relevance to the long-term care of diabetics, the device has the additional advantage that glucose measurements can be taken as often as is necessary with no adverse effects on the patient. As glucose measurements can be taken more frequently, tighter control can be maintained over the level of glucose in the blood and the risk of developing conditions related to poorly regulated blood glucose, such as retinopathy and poor circulation, will be reduced.
  • the device of the present invention may be in the form of a full size contact lens.
  • the device of the invention may be in the form of a full size contact lens which is optically correcting.
  • the device would replace "normal" optically correcting contact lenses in, for example, diabetic patients who have a need for both regular self-administered glucose testing and for optical correction of poor eyesight.
  • the device may be manufactured in the form of "disposable" contact lenses which are intended to be worn for a finite period of time, such as one day, and then disposed of.
  • the reactive components of the assay can be linked to the monomers prior to polymerisation.
  • these components can be added to the monomer mix and then entrapped in the structure of the ⁇ lens following polymerisation.
  • it is advantageous to use high molecular weight components such as polymers to which the analyte analog component of the assay (as will be defined below) is bound in order to minimise leakage by diffusion from the lens during use.
  • a further configuration is a coated lens with another outer layer of hydrogel containing the reactive components, or with the reactive components bound directly to the outside surface of the lens after manufacture.
  • the device may also be constructed in the form of a fluid composition comprising a fluid matrix in which the reactive components of the assay are uniformly suspended.
  • similar assay means to those employed in the contact lens device hereinbefore described can be delivered to the eye in fluid form, preferably using the familiar eye drop delivery system.
  • the fluid containing the assay components will migrate in the eye, lodge behind the eyelid and equilibrate with the lachrymal fluid.
  • the fluid matrix in which the reactive components are suspended may be viscous or may form a gel following migration behind the eyelid.
  • This "fluid form" device is interrogated remotely using the same optical means as is used to interrogate the contact lens device.
  • Fluid matrix-based devices include those based on microparticles or microcapsules, which in use become located, in whole or part, behind an eyelid of the user may be interrogated through the eyelid, for example using a fluorimeter device of the type described herein.
  • Preferred binding assay configurations include a reversible competitive, reagent limited, binding assay, the reactive components of which include an analyte analog and an analyte binding agent capable of reversibly binding both the analyte of interest and the analyte analog.
  • the analyte of interest and the analyte analog compete for binding to the same binding site on the analyte binding agent.
  • Such competitive binding assay configurations are well known in the art of clinical diagnostics and are described, by way of example, in the Immunoassay Handbook, ed. David Wild, Macmillan Press 1994.
  • Suitable binding agents for use in the assay include antibodies or fragments thereof which contain an antigen binding site (e.g.
  • Protein binding agents may be modified by, for example, polyethylene glycol derivatisation to increase stability and reduce irritancy and allergenicity.
  • the most preferred embodiment of the device of the invention incorporates a competitive binding assay providing an optical readout based on the technique of fluorescence energy transfer.
  • the analyte analog is labelled with a first chromophore (hereinafter referred to as the donor chromophore) and the analyte binding agent is labelled with a second chromophore (hereinafter referred to as the acceptor chromophore) .
  • Fluorescence energy transfer will only occur when the donor and acceptor chromophores are brought into close proximity by the binding of analyte analog to analyte binding agent.
  • analyte which competes with the analyte analog for binding to the analyte binding agent, the amount of quenching is reduced (resulting in an increase in the intensity of the fluorescent signal emitted by the donor chromophore or a fall in the intensity of the signal emitted by the acceptor chromophore) as the labelled analyte analog is displaced from binding to ' the analyte binding agent.
  • the intensity of the fluorescent signal emitted by the donor chromophore thus correlates with the concentration of analyte in the lachrymal fluid bathing the device.
  • An additional advantageous feature of the fluorescence energy transfer assay format arises from the fact that any fluorescent signal emitted by the acceptor chromophore following excitation with a beam of incident radiation at a wavelength within the absorption spectrum of the acceptor chromophore (but not within the absorption spectrum of the donor chromophore) is unaffected by the fluorescence energy transfer process. It is therefore possible to use the intensity of the fluorescent signal emitted by the acceptor chromophore as an internal reference signal, for example in continuous calibration of the device.
  • the fluorimeter separately measures the following parameters :
  • Figure 3 is a schematic cross section of a human eye.
  • Example 1 The procedure of Example 1 was repeated, except that the human subject had ingested 100 g of food grade glucose dissolved in distilled water 65 minutes prior to placing the lens in the eye.
  • the concentration of glucose measured by the Glucotrend 2 meter in the extracting fluid from the lens was 6.7 mmol/1.
  • the diodes (LED (1) and detector diodes (7) and (9)) were connected to a custom made driver/amplifier circuit as shown in Figure 2.
  • the circuit comprises a sender (10), current amplifiers (11) and (12), multiplexers (13) and (14), integrators (15) and (16) and an analog divider (17).
  • FRET fluorescence resonance energy transfer
  • Example 6 The procedure of Example 5 was repeated using the sub eyelid device described in Example 3. A rise in the fluorescence intensity ratio from 0.85 to 0.92 was observed using the fibre optic spectrometer when the device was removed from the eye after 15 minutes in place.
  • a sensor device comprising the sub-eyelid device treated with the FRET glucose sensor chemistry was inserted under the lower eyelid as described in Example 3. Immediately upon placing the sensing device in position a reading of fluorescence intensity from the device was taken using the fibre optic spectrometer. In this case the end of the fibre optic was placed against the lower eyelid and a measurement was made through the eyelid tissue with the eye partly closed. The fibre optic spectrometer was able to report a reading of the expected intensity ratio of 0.8 through the thin tissue of the eyelid, thus indicating that sensing devices can be operated in situ when placed under the eyelid.
  • the FRET glucose sensor chemistry components were placed in an empty dropper bottle and then 2 drops (estimated at 100 ⁇ l each) were delivered to the eye of a human subject by pulling the lower eyelid outwards and placing the drops between the lid and the eye. After blinking several times to distribute the fluid around the eye socket excess fluid was removed using a tissue placed against the closed eye. The eye was then inspected by pulling back the lower eyelid and the faint red tint of the rhodamine dye could be observed distributed evenly over the inner surface of the eyelid and on the lower part of the outer surface of the eyeball.

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

Abstract

Cette invention, qui a trait à un dispositif utilisable pour mesurer ou contrôler des analysats dans le liquide lacrymal au moyen de techniques optiques, concerne également des techniques de mesure d'analysats faisant intervenir ce dispositif.
PCT/GB2001/003078 2000-07-07 2001-07-09 Dispositif optique de mesure d'analysats dans des larmes Ceased WO2002003855A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001270774A AU2001270774A1 (en) 2000-07-07 2001-07-09 Optical device for measurement of analytes in tears

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0016841A GB0016841D0 (en) 2000-07-07 2000-07-07 Optical device for measurement of analytes in tears
GB0016841.9 2000-07-07

Publications (1)

Publication Number Publication Date
WO2002003855A1 true WO2002003855A1 (fr) 2002-01-17

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PCT/GB2001/003078 Ceased WO2002003855A1 (fr) 2000-07-07 2001-07-09 Dispositif optique de mesure d'analysats dans des larmes

Country Status (3)

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AU (1) AU2001270774A1 (fr)
GB (1) GB0016841D0 (fr)
WO (1) WO2002003855A1 (fr)

Cited By (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6681127B2 (en) 1999-08-26 2004-01-20 Novartis Ag Ocular analyte sensor
WO2004064629A1 (fr) * 2003-01-21 2004-08-05 Ehrfeld Miktotechnik Ag Systeme detecteur servant a detecter des substances a analyser dans un liquide lacrymal
WO2004046726A3 (fr) * 2002-11-20 2005-01-06 Novartis Ag Methodes et trousses pour tests de depistage rapide du diabete
US7041063B2 (en) 1996-09-04 2006-05-09 Marcio Marc Abreu Noninvasive measurement of chemical substances
EP1656882A1 (fr) * 2004-11-11 2006-05-17 Samsung Electronics Co., Ltd. Appareil et procédé pour mesurer un composant sanguin utilisant la trans-réflexion de la lumière
EP1705485A1 (fr) * 2005-03-23 2006-09-27 Roche Diagnostics GmbH Procédure de disposition de la concentration de glucose par de polarisation de la fluorescence
US7187960B2 (en) 2002-04-22 2007-03-06 Marcio Marc Abreu Apparatus and method for measuring biologic parameters
WO2007005913A3 (fr) * 2005-07-01 2007-04-05 Infotonics Technology Ct Inc Systeme de surveillance non invasif
EP2508935A1 (fr) * 2011-04-08 2012-10-10 Nxp B.V. Insert flexible pour oeil et système de mesure du glucose
US8328420B2 (en) 2003-04-22 2012-12-11 Marcio Marc Abreu Apparatus and method for measuring biologic parameters
US8385998B2 (en) 2008-10-24 2013-02-26 Jin Zhang Contact lens integrated with a biosensor for the detection of glucose and other components in tears
US8849379B2 (en) 2002-04-22 2014-09-30 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
US20140346695A1 (en) * 2013-05-21 2014-11-27 Johnson & Johnson Vision Care, Inc. Method of manufacturing an ophthalmic lens with a passive event-based coloration system
US9119530B2 (en) 2005-10-24 2015-09-01 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
CN106793943A (zh) * 2014-04-15 2017-05-31 明眸科技股份有限公司 功能性隐形眼镜以及相关的系统和方法
US9848815B2 (en) 2002-04-22 2017-12-26 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
US10227063B2 (en) 2004-02-26 2019-03-12 Geelux Holdings, Ltd. Method and apparatus for biological evaluation
US10238847B2 (en) 2014-01-22 2019-03-26 Geelux Holdings, Ltd. Devices and methods for transdermal drug delivery
US10251776B2 (en) 2014-01-10 2019-04-09 Geelux Holding, Ltd. Devices configured to monitor biological parameters, and to provide treatment, at an Abreu brain thermal tunnel
US10335040B2 (en) 2014-01-10 2019-07-02 Geelux Holdings, Ltd. Device for measuring the infrared output of the Abreu brain thermal tunnel
EP3585309A4 (fr) * 2017-04-06 2020-09-02 Teardx LLC Dispositifs oculaires et leurs procédés d'utilisation
WO2021255536A1 (fr) * 2020-06-15 2021-12-23 Johnson & Johnson Vision Care, Inc. Systèmes et procédés pour indiquer le temps écoulé depuis l'apparition d'un événement activateur
US11497405B2 (en) 2013-10-11 2022-11-15 Brain Tunnelgenix Technologies Corp. Method and apparatus for biological evaluation
US11872018B2 (en) 2015-03-10 2024-01-16 Brain Tunnelgenix Technologies Corp. Devices, apparatuses, systems, and methods for measuring temperature of an ABTT terminus
US12484790B2 (en) 2022-11-14 2025-12-02 Brain Tunnelgenix Technologies Corp. Method and apparatus for biological evaluation

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Cited By (62)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7041063B2 (en) 1996-09-04 2006-05-09 Marcio Marc Abreu Noninvasive measurement of chemical substances
US8774885B2 (en) 1996-09-04 2014-07-08 Geelux Holdings, Ltd. Device for generating a detectable signal based upon concentration of at least one substance
US7809417B2 (en) 1996-09-04 2010-10-05 Marcio Marc Abreu Contact lens for collecting tears and detecting analytes for determining health status, ovulation detection, and diabetes screening
US7756559B2 (en) 1996-09-04 2010-07-13 Marcio Marc Abreu Device for generating a detectable signal based upon antibody/antigen interaction
US6681127B2 (en) 1999-08-26 2004-01-20 Novartis Ag Ocular analyte sensor
US6850786B2 (en) 1999-08-26 2005-02-01 Novartis Ag Ocular analyte sensor
AU2001284656B2 (en) * 2001-02-23 2008-07-10 Abreu, Marcio Marc Aurelio Martins Noninvasive measurements of chemical substances
US8914089B2 (en) 2001-02-23 2014-12-16 Geelux Holdings, Ltd. Noninvasive measurement of chemical substances
US7403805B2 (en) 2001-02-23 2008-07-22 Marcio Marc Abreu Apparatus and method for noninvasive measurement of analytes from the conjunctiva using mid-infrared radiation
US9408572B2 (en) 2002-04-22 2016-08-09 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
US8849379B2 (en) 2002-04-22 2014-09-30 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
US10729371B2 (en) 2002-04-22 2020-08-04 Geelux Holdings Ltd. Apparatus and method for measuring biologic parameters
US9398856B2 (en) 2002-04-22 2016-07-26 Geelux Holdings, Ltd. Thermal imaging system
US9301719B2 (en) 2002-04-22 2016-04-05 Geelux Holding, Ltd. Apparatus and method for measuring biologic parameters
US7187960B2 (en) 2002-04-22 2007-03-06 Marcio Marc Abreu Apparatus and method for measuring biologic parameters
US9848815B2 (en) 2002-04-22 2017-12-26 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
US10123732B2 (en) 2002-04-22 2018-11-13 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
US10052030B2 (en) 2002-04-22 2018-08-21 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
US9011349B2 (en) 2002-04-22 2015-04-21 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
US9833150B2 (en) 2002-04-22 2017-12-05 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
US8721562B2 (en) 2002-04-22 2014-05-13 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
US11045092B2 (en) 2002-04-22 2021-06-29 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
WO2004046726A3 (fr) * 2002-11-20 2005-01-06 Novartis Ag Methodes et trousses pour tests de depistage rapide du diabete
US7429462B2 (en) 2002-11-20 2008-09-30 Novartis Ag Kits for assays of rapid screening of diabetes
WO2004064629A1 (fr) * 2003-01-21 2004-08-05 Ehrfeld Miktotechnik Ag Systeme detecteur servant a detecter des substances a analyser dans un liquide lacrymal
US8834020B2 (en) 2003-04-22 2014-09-16 Geelux Holdings, Ltd. Thermal imaging system
US8328420B2 (en) 2003-04-22 2012-12-11 Marcio Marc Abreu Apparatus and method for measuring biologic parameters
US10227063B2 (en) 2004-02-26 2019-03-12 Geelux Holdings, Ltd. Method and apparatus for biological evaluation
EP1656882A1 (fr) * 2004-11-11 2006-05-17 Samsung Electronics Co., Ltd. Appareil et procédé pour mesurer un composant sanguin utilisant la trans-réflexion de la lumière
US7450981B2 (en) 2004-11-11 2008-11-11 Samsung Electronics Co., Ltd. Apparatus and method for measuring blood component using light trans-reflectance
EP1705485A1 (fr) * 2005-03-23 2006-09-27 Roche Diagnostics GmbH Procédure de disposition de la concentration de glucose par de polarisation de la fluorescence
US7439080B2 (en) 2005-03-23 2008-10-21 Roche Diagnostics Operations, Inc. Method for determining the glucose concentration by fluorescence polarization
WO2007005913A3 (fr) * 2005-07-01 2007-04-05 Infotonics Technology Ct Inc Systeme de surveillance non invasif
US9445767B2 (en) 2005-10-24 2016-09-20 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
US9119530B2 (en) 2005-10-24 2015-09-01 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
US10448890B2 (en) 2005-10-24 2019-10-22 Geelux Holdings, Ltd. Apparatus and method for measuring biologic parameters
US8385998B2 (en) 2008-10-24 2013-02-26 Jin Zhang Contact lens integrated with a biosensor for the detection of glucose and other components in tears
US9737245B2 (en) 2011-04-08 2017-08-22 Nxp B.V. Flexible eye insert and glucose measuring system
CN102727218A (zh) * 2011-04-08 2012-10-17 Nxp股份有限公司 柔性眼插入物和葡萄糖测量系统
EP2508935A1 (fr) * 2011-04-08 2012-10-10 Nxp B.V. Insert flexible pour oeil et système de mesure du glucose
US9915829B2 (en) * 2013-05-21 2018-03-13 Johnson & Johnson Vision Care, Inc. Method of manufacturing an ophthalmic lens with a passive event-based coloration system
US20140346695A1 (en) * 2013-05-21 2014-11-27 Johnson & Johnson Vision Care, Inc. Method of manufacturing an ophthalmic lens with a passive event-based coloration system
US11497405B2 (en) 2013-10-11 2022-11-15 Brain Tunnelgenix Technologies Corp. Method and apparatus for biological evaluation
US11786394B2 (en) 2014-01-10 2023-10-17 Brain Tunnelgenix Technologies Corp. Devices configured to monitor biological parameters, and to provide treatment, at an Abreu brain thermal tunnel
US10251776B2 (en) 2014-01-10 2019-04-09 Geelux Holding, Ltd. Devices configured to monitor biological parameters, and to provide treatment, at an Abreu brain thermal tunnel
US10335040B2 (en) 2014-01-10 2019-07-02 Geelux Holdings, Ltd. Device for measuring the infrared output of the Abreu brain thermal tunnel
US10383525B2 (en) 2014-01-10 2019-08-20 Geelux Holdings, Ltd. Device for measuring the infrared output of the Abreu brain thermal tunnel
US12310701B2 (en) 2014-01-10 2025-05-27 Brain Tunnelgenix Technologies Corp. Device for measuring the infrared output of the abreu brain thermal tunnel
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