DE102009039724A1 - System for non-invasive measurement of blood glucose level of patient, has sensors, where system performs measurement of physicochemical characteristics of glucose related with determination of blood- and/or tissue volumes and tissue water - Google Patents

System for non-invasive measurement of blood glucose level of patient, has sensors, where system performs measurement of physicochemical characteristics of glucose related with determination of blood- and/or tissue volumes and tissue water Download PDF

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DE102009039724A1
DE102009039724A1 DE200910039724 DE102009039724A DE102009039724A1 DE 102009039724 A1 DE102009039724 A1 DE 102009039724A1 DE 200910039724 DE200910039724 DE 200910039724 DE 102009039724 A DE102009039724 A DE 102009039724A DE 102009039724 A1 DE102009039724 A1 DE 102009039724A1
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Christian Thielscher
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    • 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
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026—Measuring blood flow
    • A61B5/0295—Measuring blood flow using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
    • 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
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6825—Hand
    • A61B5/6826—Finger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6838—Clamps or clips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1073—Measuring volume, e.g. of limbs

Abstract

The system has a measuring device connected with annular sensors (1a) e.g. pressure sensor and/or a blood pressure measuring unit. The sensors surround a finger of a patient and are formed as quick silver filled tubes, and the system performs measurement of physicochemical characteristics of glucose related with determination of examined blood- and/or tissue volumes and/or tissue water. The measuring unit measures blood pressure at wrist joint of a hand, where values of the measurement are utilized for precise determination of pressure curves of pulse waves.

Description

Das Patent beschreibt ein Verfahren zur nichtinvasiven Blutzuckermessung, das darauf beruht, daß neben der Bestimmung physikochemischer o. ä. Eigenschaften des Blutes gleichzeitig auch gemessen wird, wie groß das gemessene (z. B. durchstrahlte) Volumen ist. Letzteres ändert sich z. B. in der systolischen bzw. diastolischen Phase. Durch Analyse der Bluteigenschaften unter verschiedenen Volumen erhält man Meßwerte, die eine nichtinvasive Blutzuckermessung mit außerordentlich hoher Genauigkeit erlauben.The patent describes a method for non-invasive blood glucose measurement, which is based on the fact that in addition to the determination of physicochemical or similar properties of the blood is also measured at the same time, how large the measured (eg irradiated) volume. The latter changes z. In the systolic or diastolic phase. By analyzing the blood properties under different volumes, measurements are obtained which allow a non-invasive blood glucose measurement with extremely high accuracy.

Die Erfindung bezieht sich auf ein System zur nichtinvasiven Messung des Blutzuckerspiegels, bei dem die genaue Messung durch präzise Bestimmung des verdrängten Volumens an Blut und/oder Gewebswasser erfolgt.The invention relates to a system for the noninvasive measurement of blood sugar level, in which the accurate measurement is carried out by precisely determining the displaced volume of blood and / or tissue water.

Diabetes mellitus ist eine der häufigsten schweren Erkrankungen. Weltweit waren 2007 ca. 250 Millionen Menschen in der Altersgruppe der 20– 79jährigen an Diabetes erkrankt; davon entfallen rd. 50 Millionen auf Europa und rd. 30 Millionen auf die USA. Die Zahl der weltweit Erkrankten wird bis 2025 auf 380 Millionen steigen. Die Kosten werden auf 200 bis 400 Mrd. US$ geschätzt (International Diabetes Federation: Diabetes Atlas, 3. Auflage. Brüssel 2007).Diabetes mellitus is one of the most common serious illnesses. Worldwide in 2007, approximately 250 million people in the age group of 20- to 79-year-olds had diabetes; Of this, approx. 50 million on Europe and approx. 30 million to the US. The number of people worldwide will rise to 380 million by 2025. Costs are estimated at $ 200 to $ 400 billion (International Diabetes Federation: Diabetes Atlas, 3rd edition, Brussels, 2007).

Medizinisch unterscheidet man zwei Typen der Erkrankung: den selteneren Typ I-Diabetes, der in der Jugend einsetzt und auf einer Zerstörung insulinproduzierender Zellen beruht, und den häufigeren Typ II-Diabetes, der eher ältere Patienten betrifft und auf einem relativen Insulinmangel beruht.The medical distinction between two types of disease: the rarer type I diabetes, which is used in adolescence and is based on the destruction of insulin-producing cells, and the more common type II diabetes, which is more likely to elderly patients and based on a relative insulin deficiency.

Unabhängig davon, ob es sich um Typ I oder Typ II handelt, soll der Patient seinen Blutzucker bestimmen. ( Renz-Polster, H., Krautzig, S.: Basislehrbuch Innere Medizin. München 2008, S. 868 ).Regardless of whether it is type I or type II, the patient should determine his blood sugar. ( Renz-Polster, H., Krautzig, S .: Basic textbook Internal Medicine. Munich 2008, p. 868 ).

Die derzeitigen Messgeräte setzen ausnahmslos voraus, dass der Patient invasiv eine – geringe – Menge Blut entnimmt. ( Fragkou, V., Turner, A. P. F.: Commercial Biosensors for Diabetes. In: Tuchin, V. V. (ed.): Handbook of optical sensing of glucose in biological fluids and tissues. Boca Raton, FL 2009 ). Die mehrfach tägliche Blutentnahme ist mit erheblichen Schmerzen verbunden und erzeugt außerdem Infektionsrisiken. Daher würde ein Gerät, das eine Glucosemessung ohne Verletzung ermöglicht, die Lebensqualität der Patienten erheblich verbessern.The current measuring instruments invariably require that the patient draws invasively a - small - amount of blood. ( Fragkou, V., Turner, APF: Commercial Biosensors for Diabetes. In: Tuchin, VV (ed.): Handbook of optical sensing of glucose in biological fluids and tissues. Boca Raton, FL 2009 ). The multiple daily blood collection is associated with considerable pain and also creates infection risks. Therefore, a device that allows glucose measurement without injury would significantly improve the quality of life of patients.

Für einen anderen Parameter im Blut, nämlich den Anteil des mit Sauerstoff beladenen Hämoglobins, gibt es ein solches Verfahren seit vielen Jahren: die sogenannte Pulsoximetrie (auch Pulsoxymetrie genannt). Sie basiert darauf, dass ein Lichtstrahl durch den Finger des Patienten geschickt und auf der anderen Seite gemessen wird, wie viel von dem Licht absorbiert wurde. Da sauerstoffarmes bzw. sauerstoffgesättigtes Hämoglobin unterschiedliche Absorptionsspektren haben, kann man daraus die Konzentrationen bestimmen. (Eine detaillierte Beschreibung findet sich z. B. in: Webster, J. G.: Design of Pulse Oximeters. Bristol 1997 ). Grundsätzlich muss diese Messung nicht im Durchlicht erfolgen, sondern man kann auch die Reflexion messen.For another parameter in the blood, namely the proportion of oxygen-loaded hemoglobin, there is such a method for many years: the so-called pulse oximetry (also called pulse oximetry). It is based on sending a beam of light through the patient's finger and measuring how much of the light has been absorbed on the other side. Since oxygen-poor or oxygen-saturated hemoglobin have different absorption spectra, one can determine the concentrations from this. (A detailed description can be found z. Webster, JG: Design of Pulse Oximeters. Bristol 1997 ). Basically, this measurement does not have to be done in transmitted light, but you can also measure the reflection.

Das Verfahren der Pulsoximetrie benutzt neben der Messung der Lichtabsorption ein weiteres Verfahren, das im Prinzip auch für die Blutzuckermessung anwendbar ist: es misst die Absorption zu verschiedenen Zeitpunkten einer Pulswelle. Da während der systolischen Phase die Blutgefäße mit mehr Blut gefüllt sind als in der diastolischen, kann man darauf schließen, wie viel Lichtabsorption auf das Gewebe entfällt und wie viel auf das Blut. Statt die Pulswelle passiv zu registrieren, kann man natürlich auch die Durchblutung beeinflussen, z. B., indem man – wie bei der Blutdruckmessung – eine Manschette auf übersystolischen Druck aufbläst, worauf die Durchblutung vorübergehend stoppt.The method of pulse oximetry uses, in addition to the measurement of light absorption, another method that is also applicable in principle for the blood sugar measurement: it measures the absorption at different times of a pulse wave. Since during the systolic phase, the blood vessels are filled with more blood than in the diastolic, one can conclude how much light absorption is due to the tissue and how much on the blood. Instead of passively registering the pulse wave, one can of course also influence the blood circulation, z. For example, by inflating a cuff to over-systolic pressure, as in blood pressure measurement, and then temporarily stopping blood flow.

Bei Laborversuchen ist es seit vielen Jahren gelungen, die Zuckerkonzentration einer Lösung mit Methoden der Lichtabsorption zu messen. (Z. B. Müller, A.: Blutzuckermessungen ohne Verletzungen. Vallendar 1994 ). Dazu benutzt man die Eigenschaft der Glucose, Licht unterschiedlicher Wellenlängen unterschiedlich stark zu absorbieren; das Verfahren ähnelt also sehr stark dem der Pulsoximterie. Neben seiner spezifischen Lichtabsorption hat Glucose weitere physikalische und chemische Eigenschaften, die sich spezifisch von anderen Stoffen unterscheiden und prinzipiell für die Messung seiner Konzentration geeignet sind. Daher stehen inzwischen neben optischen Verfahren auch solche der Absorption im Infrarotbereich, photoakustische, Raman- oder andere spektroskopische Methoden usw. zur Verfügung. (Einen orientierenden Überblick bieten z. B. Kondepati, V. R. und Heise, H. M.: Recent Progress in analytical instrumentation for glycemic control in diabetic and critically ill patients. Anal Bioanal Chem (2007) 388: 545–563 .)In laboratory experiments, it has been possible for many years to measure the sugar concentration of a solution using methods of light absorption. (For example, Müller, A .: Blood sugar measurements without injuries. Vallendar 1994 ). For this purpose one uses the property of glucose to absorb light of different wavelengths to different degrees; the procedure is very similar to that of pulse oximetry. In addition to its specific light absorption, glucose has other physical and chemical properties that differ specifically from other substances and are in principle suitable for measuring its concentration. Therefore, in addition to optical methods, also those of absorption in the infrared range, photoacoustic, Raman or other spectroscopic methods, etc. are available. (For example, provide an orienting overview Kondepati, VR and Heise, HM: Recent progress in analytical instrumentation for glycemic control in diabetic and critically ill patients. Anal Bioanal Chem (2007) 388: 545-563 .)

Daher liegt der Versuch nahe, die Prinzipien der Pulsoximetrie, nämlich die Messung der Absorption oder einer anderen spezifischen Eigenschaft und das Verhalten einer Pulswelle auf die Messung der Glucose zu übertragen. Solche Vorhaben sind in dem o. g. Buch von Tuchin beschrieben. Vielfach wurden sie auch zum Patent angemeldet, z. B. bereits 1997 als US-Patent 5638816 , aber auch später, z. B. 2006 als US Patent 6993372. Therefore, the attempt to transfer the principles of pulse oximetry, namely the measurement of the absorption or of another specific property and the behavior of a pulse wave, to the measurement of the glucose is obvious. Such projects are described in the book by Tuchin mentioned above. In many cases, they were also registered for a patent, z. B. as early as 1997 U.S. Patent 5,638,816 , but also later, z. 2006 as US Patent 6993372.

Allerdings ist es bisher nicht gelungen, diese Laborversuche in die medizinische Praxis umzusetzen. Das Hauptproblem, das bisher ungelöst war und mit der vorliegenden Erfindung gelöst wird, besteht darin, dass das Verhältnis zwischen dem Signal der Glucose, z. B. seiner spezifischen Absorption, sehr gering ist im Verhältnis aller übrigen Substanzen, Gewebe usw., die ebenfalls Licht absorbieren. Das liegt wiederum v. a. an der im Verhältnis zum Hämoglobin sehr geringen Lichtabsorption der Glucose. Trotz ausgefeilter statistischer Verfahren ist es bisher nicht gelungen, die Glucosekonzentration aus dem Grundrauschen der übrigen Lichtabsorber mit hinreichender Genauigkeit herauszurechnen.However, so far it has not been successful, these laboratory experiments in medical practice implement. The main problem that has been unresolved and solved by the present invention is that the ratio between the signal of glucose, e.g. B. its specific absorption, is very low in the ratio of all other substances, tissues, etc., which also absorb light. This, in turn, is mainly due to the very low light absorption of glucose in relation to hemoglobin. Despite sophisticated statistical methods, it has not yet been possible to calculate the glucose concentration from the background noise of the other light absorbers with sufficient accuracy.

Die Erfindung löst das Problem, indem sie die Messdaten durch Einführung einer weiteren Messgrösse präzisiert, nämlich durch die präzise Bestimmung des gemessenen Blutvolumens.The invention solves the problem by specifying the measured data by introducing a further measured variable, namely by the precise determination of the measured blood volume.

In der einfachsten Version besteht das System aus einem Messgerät, das eine physikochemische Eigenschaft der Glucose nutzt, z. B. ihre Absorption, einem Sensor, der das untersuchte Blutvolumen misst, und einem Computer.In the simplest version, the system consists of a measuring device that uses a physicochemical property of glucose, eg. Their absorption, a sensor that measures the volume of blood being examined, and a computer.

1 zeigt eine mögliche Ausgestaltung des Systems. Abgebildet ist der Finger eines Patienten, der von einem ringförmigen Sensor 1a umschlossen ist. Dabei kann es sich z. B. um einen quecksilbergefüllten Schlauch handeln; verändert sich das Volumen des Fingers, so dehnt sich der Schlauch, wodurch sein Durchmesser ab- und der elektrische Widerstand zunimmt; daraus lasst sich der Ringdurchmesser errechnen. 1 shows a possible embodiment of the system. Pictured is the finger of a patient, by an annular sensor 1a is enclosed. It may be z. B. act to a mercury-filled tube; If the volume of the finger changes, the tube expands, reducing its diameter and increasing the electrical resistance. From this the ring diameter can be calculated.

Im Rahmen der Durchblutung verändert sich der Durchmesser des Fingers. Im gleichen Rhythmus verändern die Lichtquelle 1b und der Empfänger 1c ihre Position. Aus dem Abstand von 1b und 1c (der durch einen entsprechenden Sensor ermittelt wird oder, wie in 1 gezeigt, durch die Anbringung am Ring 1a aus dessen Werten bekannt ist) und den Messwerten von 1a kann man exakt ermitteln, wie hoch das durchstrahlte Volumen ist. Da dieses Volumen mit der Pulswelle schwankt, kann man errechnen, wie hoch das durchstrahlte Blutvolumen im Maximum, im Minimum und dazwischen ist. Dadurch lassen sich Störeffekte bei der Blutzuckerbestimmung ermitteln und herausrechnen.As part of the blood circulation, the diameter of the finger changes. The light source changes in the same rhythm 1b and the receiver 1c your position. From the distance from 1b and 1c (which is determined by a corresponding sensor or, as in 1 shown by the attachment to the ring 1a whose values are known) and the measured values of 1a It is possible to determine exactly how high the irradiated volume is. Since this volume fluctuates with the pulse wave, one can calculate how high the irradiated blood volume is in the maximum, in the minimum and in between. As a result, disruptive effects in the determination of blood sugar can be determined and calculated out.

ZITATE ENTHALTEN IN DER BESCHREIBUNG QUOTES INCLUDE IN THE DESCRIPTION

Diese Liste der vom Anmelder aufgeführten Dokumente wurde automatisiert erzeugt und ist ausschließlich zur besseren Information des Lesers aufgenommen. Die Liste ist nicht Bestandteil der deutschen Patent- bzw. Gebrauchsmusteranmeldung. Das DPMA übernimmt keinerlei Haftung für etwaige Fehler oder Auslassungen.This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Zitierte PatentliteraturCited patent literature

  • US 5638816 [0010] US 5638816 [0010]
  • US 6993372 [0010] US 6993372 [0010]

Zitierte Nicht-PatentliteraturCited non-patent literature

  • Renz-Polster, H., Krautzig, S.: Basislehrbuch Innere Medizin. München 2008, S. 868 [0005] Renz-Polster, H., Krautzig, S .: Basic textbook Internal Medicine. Munich 2008, p. 868 [0005]
  • Fragkou, V., Turner, A. P. F.: Commercial Biosensors for Diabetes. In: Tuchin, V. V. (ed.): Handbook of optical sensing of glucose in biological fluids and tissues. Boca Raton, FL 2009 [0006] Fragkou, V., Turner, APF: Commercial Biosensors for Diabetes. In: Tuchin, VV (ed.): Handbook of optical sensing of glucose in biological fluids and tissues. Boca Raton, FL 2009 [0006]
  • B. in: Webster, J. G.: Design of Pulse Oximeters. Bristol 1997 [0007] Webster, JG: Design of Pulse Oximeters. Bristol 1997 [0007]
  • Müller, A.: Blutzuckermessungen ohne Verletzungen. Vallendar 1994 [0009] Müller, A .: Blood sugar measurements without injuries. Vallendar 1994 [0009]
  • Kondepati, V. R. und Heise, H. M.: Recent Progress in analytical instrumentation for glycemic control in diabetic and critically ill patients. Anal Bioanal Chem (2007) 388: 545–563 [0009] Kondepati, VR and Heise, HM: Recent progress in analytical instrumentation for glycemic control in diabetic and critically ill patients. Anal Bioanal Chem (2007) 388: 545-563 [0009]

Claims (2)

System zur nichtinvasiven Messung des Blutzuckerspiegels, dadurch gekennzeichnet, dass die Messung der physikochemischen Eigenschaften der Glucose mit einer Bestimmung des untersuchten Blut- und/oder Gewebsvolumens und/oder Gewebswassers verknüft wird.System for the non-invasive measurement of blood sugar levels, characterized in that the measurement of the physicochemical properties of the glucose is linked to a determination of the blood and / or tissue volume and / or tissue water being examined. System gemäß Anspruch 1, dadurch gekennzeichnet, dass das Messgerät mit weiteren Sensoren verbunden wird, z. B. mit einem Drucksensor und/oder einem Gerät zur Messung des Blutdrucks, die z. B. am Handgelenk der gleichen oder der anderen Hand erfolgen kann und deren Werte für die Berechnungen, z. B. zur präzisen Bestimmung der Verlaufskurve der Pulswelle verwendet werden.System according to claim 1, characterized in that the measuring device is connected to other sensors, for. B. with a pressure sensor and / or a device for measuring blood pressure, the z. B. on the wrist of the same or the other hand can be done and their values for the calculations, eg. B. are used for precise determination of the curve of the pulse wave.
DE200910039724 2009-08-28 2009-08-28 System for non-invasive measurement of blood glucose level of patient, has sensors, where system performs measurement of physicochemical characteristics of glucose related with determination of blood- and/or tissue volumes and tissue water Withdrawn DE102009039724A1 (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5638816A (en) 1995-06-07 1997-06-17 Masimo Corporation Active pulse blood constituent monitoring
US6993372B2 (en) 2003-06-03 2006-01-31 Orsense Ltd. Method and system for use in non-invasive optical measurements of blood parameters

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5638816A (en) 1995-06-07 1997-06-17 Masimo Corporation Active pulse blood constituent monitoring
US6993372B2 (en) 2003-06-03 2006-01-31 Orsense Ltd. Method and system for use in non-invasive optical measurements of blood parameters

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
B. in: Webster, J. G.: Design of Pulse Oximeters. Bristol 1997
Fragkou, V., Turner, A. P. F.: Commercial Biosensors for Diabetes. In: Tuchin, V. V. (ed.): Handbook of optical sensing of glucose in biological fluids and tissues. Boca Raton, FL 2009
Kondepati, V. R. und Heise, H. M.: Recent Progress in analytical instrumentation for glycemic control in diabetic and critically ill patients. Anal Bioanal Chem (2007) 388: 545-563
Müller, A.: Blutzuckermessungen ohne Verletzungen. Vallendar 1994
Renz-Polster, H., Krautzig, S.: Basislehrbuch Innere Medizin. München 2008, S. 868

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