WO2006101389A1 - Determination of the state of health of a human being - Google Patents

Determination of the state of health of a human being Download PDF

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Publication number
WO2006101389A1
WO2006101389A1 PCT/NL2006/000151 NL2006000151W WO2006101389A1 WO 2006101389 A1 WO2006101389 A1 WO 2006101389A1 NL 2006000151 W NL2006000151 W NL 2006000151W WO 2006101389 A1 WO2006101389 A1 WO 2006101389A1
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WO
WIPO (PCT)
Prior art keywords
compounds
state
secreted
reaction products
related reaction
Prior art date
Application number
PCT/NL2006/000151
Other languages
French (fr)
Inventor
Albert Van Gool
Original Assignee
Alb. Van Gool R & D
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 Alb. Van Gool R & D filed Critical Alb. Van Gool R & D
Priority to US11/887,033 priority Critical patent/US8660624B2/en
Priority to EP06732958.1A priority patent/EP1916961B1/en
Publication of WO2006101389A1 publication Critical patent/WO2006101389A1/en

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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, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507—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 specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/1451—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 specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
    • A61B5/14514—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 specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
    • 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

Definitions

  • the invention concerns the determination of the state of an entity, in particular the state of health of a human being or animal, more in particular the diabetic condition.
  • a non-invasive diagnostic system for monitoring the condition of an entity, e.g. the diabetic condition of a human being or animal.
  • an entity e.g. the diabetic condition of a human being or animal.
  • a number of volatile or gaseous compounds secreted by the entity or body that characterise the condition or state are determined.
  • the obtained data are processed in such a way that conclusions may be drawn concerning the condition or state.
  • An important application is to monitor human beings with diabetes mellitus, diabetes for short, a chronic disorder of the glucose metabolism in the body. Because the pancreas, that produces the hormone insulin that controls the uptake of glucose in cells, does not work or works insufficiently, blood glucose is not absorbed adequately or at all. People suffering from diabetes have an increased risk of cardiovascular diseases, high blood pressure, neurological disorders, skin disorders, deterioration of the retina, kidney disorders and impotence to name but a few, which can lead to serious debilitation and in extreme cases to an early death. The number of diabetics worldwide is estimated at 100 - 150 million and the number of people diagnosed with diabetes has increased rapidly over the past decades from 2-3% to 5-6%.
  • US 2005/0010090 provides a more extensive overview of known methods and techniques to determine blood glucose levels.
  • methods referred to as 'traditional invasive', 'alternative invasive', 'non-invasive' and 'implantable' and techniques such as 'direct' and 'indirect' glucose measurement.
  • a traditional invasive method a sample of arterial or venous blood is drawn by means of a needle, or a capillary blood sample is taken by means of a lancet.
  • this method is considered to be inconvenient and piercing the skin is painful.
  • the analysis of the sample thus obtained yields only a random indication.
  • an adequate control of blood glucose levels requires a continuous or at least frequent (during night and day) measurement. It will be obvious that this entails unacceptable stress for the patient and is practically impossible to implement.
  • the alternative can refer to the site where the sample is taken but often it refers to an alternative way to draw a sample of interstitial fluid, blood or a mixture of both.
  • This can be done by (i) piercing the skin with a laser, (ii) to enhance the permeation of interstitial fluid through the skin electrically, or (iii) to locally apply a reduced pressure to the skin in order to stimulate the permeation of interstitial fluid through the skin.
  • spectrophotometrical methods Reni, fluorescence, visible light, UV and IR
  • electrochemical, (electro)enzymatic or colorimetrical methods are used besides electrochemical, (electro)enzymatic or colorimetrical methods.
  • the glucose levels can be determined directly or indirectly via a number of compounds that characterise the glucose level or diabetic condition.
  • known methods and techniques turn out to be relatively laborious and difficult to perform by a layman, insufficiently fast or accurate, often are insufficiently reliable, often costly and unsuitable for (semi)- continuously or automatically measuring the blood glucose levels.
  • the cited shortcomings prevent a (widespread) application of these techniques.
  • a non-invasive method no sample is taken but a physiological parameter is determined by studying an area of the body and through a certain algorithm the glucose level in the blood is deduced.
  • a form of spectroscopy is used, but thermal or electrical methods are used as well.
  • Such known techniques again prove to be fairly laborious, difficult to perform by a layman, and expensive. Consequently non-invasive methods based on the mentioned techniques are not applied (on a wider scale).
  • US 5,377,008 and US 6,429,023 describe optical devices for determining characteristics of liquids, based on a sensor surface linked to a (Mach-Zehnder) interferometer.
  • US 6,618,536 describes a similar device with which in principle all kinds of parameters such as air humidity, chemical composition of gases or liquids and variations in optical refraction index and temperature can be measured. Such devices prove to be very sensitive with very low detection limits. Moreover, they can be made to be selective for one or more specific compounds.
  • the invention provides a system for the determination of the state of an entity, in particular the health of a human being or animal, comprising: contacting secreted compounds or corresponding reaction products with a surface provided to this end, the surface being linked to an optical waveguide in such a way that compounds binding to the surface can influence the propagation of light in the waveguide; determining the occurring influence by means of an interferometric measuring principle; and deducing the state from the occurring influence.
  • 'to secrete' is intended to mean 'secretion by the entity', in particular 'secretion by the body of the humans being or the animal without a traditional invasive measure'.
  • 'determining the state (of health)' it is meant in the present invention 'at least partially determining the state (of health)'.
  • the secreted compounds can be secreted by the skin in either liquid or gaseous form, possibly solved in e.g. sweat or interstitial fluid of mixed with air or as an aerosol, but also by the lungs in the shape of gases or liquid droplets present in the exhaled air.
  • the state is the diabetic condition and the secreted compounds characterise the diabetic condition.
  • each surface can be more or less selective for one or more specific compounds, or one or more reference measurements can be performed.
  • Such a system can be made affordable and user-friendly. This way the condition of an entity, in particular the state of health, more in particular the diabetic condition of a human being or animal can be determined pain-free or at least with minimal stress, sufficiently precise, possibly automatically, possibly continuously or at least a sufficiently large number of times per unit of time.
  • the system can also comprise the stimulation of the secretion of compounds. E.g. the permeation of compounds through the skin can be stimulated electrically or thermally or by applying a reduced pressure.
  • the system can also comprise guiding the secreted compounds or related reaction products to the surface. In this case adjuvants or reagents like oxygen can also be added.
  • the system can also comprise the selective permeation of secreted compounds or related reaction products, e.g. by means of one or more suitable selectively permeable membranes or filters.
  • the system can also comprise the selective binding of the secreted compounds or related reaction products to the surface, so only the desired specific compound or compounds are bonded to the surface. This way the system can be made to be more selective, undesirable polluting or interfering compounds are removed and the sensitivity, accuracy and reproducibility of the system can be increased, as well as its life-span.

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

Abstract

The invention provides a method for the determination of the state of an entity, in particular the state of health of a human being or animal, comprising: - contacting secreted compounds or related reaction products with a surface provided to this end, the surface being linked to an optical waveguide in such a way that compounds binding to the surface can influence the propagation of light in the waveguide; determining the occurring influence by means of an optical interferometric measuring principle; and - deducing the state from the occurring influence. The invention further provides a device for the determination of such a state. Such a method and device can be applied with advantage in particular to determine the diabetic condition of a human being or animal.

Description

DETERMINATION OF THE STATE OF HEALTH OF A HUMAN BEING
Field of the invention
The invention concerns the determination of the state of an entity, in particular the state of health of a human being or animal, more in particular the diabetic condition.
Background of the invention
In US2003/0008407 a non-invasive diagnostic system is described for monitoring the condition of an entity, e.g. the diabetic condition of a human being or animal. In this system a number of volatile or gaseous compounds secreted by the entity or body that characterise the condition or state are determined. The obtained data are processed in such a way that conclusions may be drawn concerning the condition or state.
An important application is to monitor human beings with diabetes mellitus, diabetes for short, a chronic disorder of the glucose metabolism in the body. Because the pancreas, that produces the hormone insulin that controls the uptake of glucose in cells, does not work or works insufficiently, blood glucose is not absorbed adequately or at all. People suffering from diabetes have an increased risk of cardiovascular diseases, high blood pressure, neurological disorders, skin disorders, deterioration of the retina, kidney disorders and impotence to name but a few, which can lead to serious debilitation and in extreme cases to an early death. The number of diabetics worldwide is estimated at 100 - 150 million and the number of people diagnosed with diabetes has increased rapidly over the past decades from 2-3% to 5-6%.
As yet there is no cure for diabetes, but the above complications can be prevented or at least reduced or postponed to a considerable extent by an adequate control of the blood glucose level. This can be done by medicinal treatment or administration of insulin in combination with a suitable diet and lifestyle. A good - in ideal cases a continuous - control of blood glucose levels is of prime importance. Ideally values of between 4 and 10 mmole/1 (the extreme values of a non-diabetic person) should be maintained. In US2003/0008407 only a limited number of known possible sensors and detection facilities are cited briefly - an oscillator, a sensor based on electrical conductivity and traditional HPLC, GC or MS methods.
US 2005/0010090 provides a more extensive overview of known methods and techniques to determine blood glucose levels. Here a distinction is made between methods referred to as 'traditional invasive', 'alternative invasive', 'non-invasive' and 'implantable' and techniques such as 'direct' and 'indirect' glucose measurement. In a traditional invasive method a sample of arterial or venous blood is drawn by means of a needle, or a capillary blood sample is taken by means of a lancet. However, this method is considered to be inconvenient and piercing the skin is painful. Also the analysis of the sample thus obtained yields only a random indication. As has been said before, an adequate control of blood glucose levels requires a continuous or at least frequent (during night and day) measurement. It will be obvious that this entails unacceptable stress for the patient and is practically impossible to implement.
In an alternative invasive method the alternative can refer to the site where the sample is taken but often it refers to an alternative way to draw a sample of interstitial fluid, blood or a mixture of both. This can be done by (i) piercing the skin with a laser, (ii) to enhance the permeation of interstitial fluid through the skin electrically, or (iii) to locally apply a reduced pressure to the skin in order to stimulate the permeation of interstitial fluid through the skin. To determine the glucose levels in the obtained biological samples spectrophotometrical methods (Raman, fluorescence, visible light, UV and IR) are used besides electrochemical, (electro)enzymatic or colorimetrical methods. The glucose levels can be determined directly or indirectly via a number of compounds that characterise the glucose level or diabetic condition. In practice, such known methods and techniques turn out to be relatively laborious and difficult to perform by a layman, insufficiently fast or accurate, often are insufficiently reliable, often costly and unsuitable for (semi)- continuously or automatically measuring the blood glucose levels. To date, the cited shortcomings prevent a (widespread) application of these techniques. In a non-invasive method no sample is taken but a physiological parameter is determined by studying an area of the body and through a certain algorithm the glucose level in the blood is deduced. In many cases a form of spectroscopy is used, but thermal or electrical methods are used as well. Such known techniques again prove to be fairly laborious, difficult to perform by a layman, and expensive. Consequently non-invasive methods based on the mentioned techniques are not applied (on a wider scale).
Furthermore a number of types of short-term or long term implantable glucose sensors are under development. US 5,377,008 and US 6,429,023 describe optical devices for determining characteristics of liquids, based on a sensor surface linked to a (Mach-Zehnder) interferometer. US 6,618,536 describes a similar device with which in principle all kinds of parameters such as air humidity, chemical composition of gases or liquids and variations in optical refraction index and temperature can be measured. Such devices prove to be very sensitive with very low detection limits. Moreover, they can be made to be selective for one or more specific compounds.
It can be concluded that there is very big need for an affordable, user-friendly system with which the state of health, in particular the diabetic condition of a human can be determined continuously, or at least a sufficient number of times a day, pain-free or at least with minimal stress, sufficiently precise and preferably automatically. In practice none of the known systems, methods and techniques fulfils this need. The purpose of the invention is to provide such a system.
Summary of the invention
To this end, the invention provides a system for the determination of the state of an entity, in particular the health of a human being or animal, comprising: contacting secreted compounds or corresponding reaction products with a surface provided to this end, the surface being linked to an optical waveguide in such a way that compounds binding to the surface can influence the propagation of light in the waveguide; determining the occurring influence by means of an interferometric measuring principle; and deducing the state from the occurring influence.
In the framework of the invention, 'to secrete' is intended to mean 'secretion by the entity', in particular 'secretion by the body of the humans being or the animal without a traditional invasive measure'. By 'determining the state (of health)' it is meant in the present invention 'at least partially determining the state (of health)'.
The secreted compounds can be secreted by the skin in either liquid or gaseous form, possibly solved in e.g. sweat or interstitial fluid of mixed with air or as an aerosol, but also by the lungs in the shape of gases or liquid droplets present in the exhaled air. In a preferred embodiment, the state is the diabetic condition and the secreted compounds characterise the diabetic condition.
Evidently, several surfaces can be applied, linked to one or more interferometric systems. In this case, each surface can be more or less selective for one or more specific compounds, or one or more reference measurements can be performed.
Such a system can be made affordable and user-friendly. This way the condition of an entity, in particular the state of health, more in particular the diabetic condition of a human being or animal can be determined pain-free or at least with minimal stress, sufficiently precise, possibly automatically, possibly continuously or at least a sufficiently large number of times per unit of time.
The system can also comprise the stimulation of the secretion of compounds. E.g. the permeation of compounds through the skin can be stimulated electrically or thermally or by applying a reduced pressure. The system can also comprise guiding the secreted compounds or related reaction products to the surface. In this case adjuvants or reagents like oxygen can also be added. The system can also comprise the selective permeation of secreted compounds or related reaction products, e.g. by means of one or more suitable selectively permeable membranes or filters. The system can also comprise the selective binding of the secreted compounds or related reaction products to the surface, so only the desired specific compound or compounds are bonded to the surface. This way the system can be made to be more selective, undesirable polluting or interfering compounds are removed and the sensitivity, accuracy and reproducibility of the system can be increased, as well as its life-span.

Claims

Claims
1. Method for the determination of the state of an entity, in particular the state of health of a human being or animal, characterised in that the method comprises: - contacting secreted compounds or related reaction products with a surface provided to this end, the surface being linked to an optical waveguide in such a way that compounds binding to the surface can influence the propagation of light in the waveguide; determining the occurring influence by means of an optical interferometric measuring principle; and
- deducing the state from the occurring influence.
2. Method according to claim 1, characterised in that the secreted compounds are secreted by the skin.
3. Method according to claim 1 or 2, characterised in that the state concerns the diabetic condition and the secreted compounds are characteristic of the diabetic condition.
4. Method according to any of the claims 1 - 3 characterised in that the method also comprises stimulating the secretion of compounds.
5. Method according to any of the claims 1 - 4, characterised in that the method also comprises guiding the secreted compounds or related reaction products to the surface.
6. Method according to any of the claims 1 - 5, characterised in that the method also comprises selectively allowing the permeation of secreted compounds or related reaction products.
7. Method according to any of the claims 1 - 6, characterised in that the method also comprises selectively binding of secreted compounds or related reaction products to the surface.
8. Device for the determination of the state of an entity, in particular the state of health of a human being or animal, characterised in that the device comprises: - a surface and an optical waveguide that are linked in such a way that compounds binding to the surface can influence the propagation of light in the waveguide; first means to bring secreted compounds or related reaction products in contact with the surface; an optical interferometer for the determination of the occurring influence; and second means to deduce the state from the occurring influence.
9. Device according to claim 8, characterised in that the secreted compounds have been secreted by the skin.
10. Device according to claim 8 or 9, characterised in that the state is the diabetic condition and the secreted compounds are characteristic of the diabetic condition.
11. Device according to any of the claims 8 - 10, characterised in that the device also comprises third means to stimulate the secretion of compounds.
12. Device according to any of the claims 8 - 11, characterised in that the device also comprises fourth means to guide the secreted compounds or related reaction products to the surface.
13. Device according to any of the claims 8 - 12, characterised in that the device also comprises fifth means to selectively allow the permeation of secreted compounds or related reaction products.
14. Device according to any of the claims 8 - 13, characterised in that the surface is able to selectively bind secreted compounds or related reaction products.
PCT/NL2006/000151 2005-03-24 2006-03-22 Determination of the state of health of a human being WO2006101389A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US11/887,033 US8660624B2 (en) 2005-03-24 2006-03-22 Determination of the state of health of a human being
EP06732958.1A EP1916961B1 (en) 2005-03-24 2006-03-22 Determination of the state of health of a human being

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
NL1028619A NL1028619C2 (en) 2005-03-24 2005-03-24 Method and device for determining the state of an entity, in particular the state of health of a human or animal.
NL1028619 2005-03-24

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Publication Number Publication Date
WO2006101389A1 true WO2006101389A1 (en) 2006-09-28

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US (1) US8660624B2 (en)
EP (1) EP1916961B1 (en)
NL (1) NL1028619C2 (en)
WO (1) WO2006101389A1 (en)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040254438A1 (en) * 2003-01-09 2004-12-16 The Regents Of The University Of California Implantable devices and methods for measuring intraocular, subconjunctival or subdermal pressure and/or analyte concentration
WO2005001447A1 (en) * 2003-06-27 2005-01-06 Bayer Healthcare Llc Ir-atr-based process and apparatus for analysing very small amounts of sample in the nanoliter range

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US5377008A (en) * 1990-09-20 1994-12-27 Battelle Memorial Institute Integrated optical compensating refractometer apparatus
US5804453A (en) * 1996-02-09 1998-09-08 Duan-Jun Chen Fiber optic direct-sensing bioprobe using a phase-tracking approach
NL1006323C2 (en) * 1997-06-16 1998-12-17 Mierij Meteo Bv Integrated optical waveguide system.
US6429023B1 (en) * 1998-07-20 2002-08-06 Shayda Technologies, Inc. Biosensors with polymeric optical waveguides
AT409451B (en) * 1999-12-14 2002-08-26 Hoffmann La Roche DEVICE FOR DETERMINING THE LOCAL DISTRIBUTION OF A MEASURED VALUE
CA2688795C (en) * 2000-06-01 2014-07-08 Science Application International Corporation Systems and methods for monitoring health and delivering drugs transdermally
US7076371B2 (en) * 2001-03-03 2006-07-11 Chi Yung Fu Non-invasive diagnostic and monitoring method and apparatus based on odor detection
CN100421615C (en) * 2002-03-08 2008-10-01 三西斯医学股份有限公司 Compact apparatus for noninvasive measurement of glucose through near-infrared spectroscopy
EP1464273B1 (en) * 2003-04-03 2006-11-29 Matsushita Electric Industrial Co., Ltd. Method and device for measuring concentration of specific component
US7394547B2 (en) * 2003-11-06 2008-07-01 Fortebio, Inc. Fiber-optic assay apparatus based on phase-shift interferometry
US7184148B2 (en) * 2004-05-14 2007-02-27 Medeikon Corporation Low coherence interferometry utilizing phase

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040254438A1 (en) * 2003-01-09 2004-12-16 The Regents Of The University Of California Implantable devices and methods for measuring intraocular, subconjunctival or subdermal pressure and/or analyte concentration
WO2005001447A1 (en) * 2003-06-27 2005-01-06 Bayer Healthcare Llc Ir-atr-based process and apparatus for analysing very small amounts of sample in the nanoliter range

Also Published As

Publication number Publication date
US8660624B2 (en) 2014-02-25
NL1028619C2 (en) 2006-09-27
EP1916961A1 (en) 2008-05-07
US20090062631A1 (en) 2009-03-05
EP1916961B1 (en) 2013-10-30

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