EP2849647A1 - Dispositif de détermination polarimétrique de la glycémie in vivo - Google Patents

Dispositif de détermination polarimétrique de la glycémie in vivo

Info

Publication number
EP2849647A1
EP2849647A1 EP13712708.0A EP13712708A EP2849647A1 EP 2849647 A1 EP2849647 A1 EP 2849647A1 EP 13712708 A EP13712708 A EP 13712708A EP 2849647 A1 EP2849647 A1 EP 2849647A1
Authority
EP
European Patent Office
Prior art keywords
display unit
radiation
circuit board
measuring head
blood sugar
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP13712708.0A
Other languages
German (de)
English (en)
Inventor
Carolin WAHLBRING
Dirk KUNST
Heinz-Peter Utz
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.)
Vivantum GmbH
Original Assignee
Vivantum 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 Vivantum GmbH filed Critical Vivantum GmbH
Publication of EP2849647A1 publication Critical patent/EP2849647A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—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
    • A61B5/145—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
    • A61B5/14558—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 by polarisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/046—Arrangements of multiple sensors of the same type in a matrix array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/166—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted on a specially adapted printed circuit board

Definitions

  • the invention relates to a device for polarimetric in vivo determination of the blood sugar concentration by means of a sensor arrangement comprising at least one radiation emitting and at least one group of radiation-sensitive semiconductor diodes for analyzing the blood glucose content caused by the polarization changes and with a display unit according to claim 1 and a special measuring head unit therefor according to claim 11.
  • a light source of the local detector is preferably a laser diode with a defined wavelength of light in
  • the light source is directed with its output light beam perpendicular to the skin surface of a subject.
  • the light beam exits through an opening in the top of a cone and strikes the skin.
  • the light is scattered in all directions, and because of the high density of the scattering centers, many scattering processes occur with directional changes, so that light from the subcutaneous body region is scattered back to the skin / air interface where it comes out again and can be examined. If multiple vectors with the same
  • Embodiment according to DE 195 19 051 B4 can linearly polarized light of the radiation source via a first optical waveguide to the
  • At least one second optical waveguide the entrance end of which is arranged at a specific distance from the skin surface, absorbs the scattered light emerging essentially vertically from the skin surface and conducts it to a detector arrangement.
  • a device for determining biological, chemical and / or physical parameters in living biological tissue with a power supply unit, a laser operating unit and at least one directed to the biological tissue laser source is presented.
  • a sensor unit for detecting the light backscattered and / or absorbed by the biological tissue as well as a control unit, a storage and processing unit and an interface for an external data processing unit are provided.
  • Calibration phase for determining a reference quantity from reference vectors, each consisting of an independent determination of a
  • Glucose parameters irradiating unpolarized laser light on the biological tissue and registering a measured value vector of a series of optical measurements and performing an interpolation made.
  • the interpolation phase is used to determine an interpolation set of interpolation vectors, each consisting of irradiating unpolarized laser light onto the biological tissue and registering a measured value vector from a backscattered light intensity with a subsequent determination of an interpolated parameter from the reference set.
  • a method and a device for noninvasive blood glucose measurement is previously known.
  • a measurement volume of the blood is arranged between a light source and a detector, wherein the corresponding area is transilluminated by means of polarized infrared light radiation.
  • the infrared radiation is generated by laser diodes and in emitted different polarization levels and modulated with a defined frequency.
  • a detector is present, which has a polarization preferred direction. Emitter or light source and detector or light receiver or light sensor are arranged so that they are located on both sides of a blood-filled skin area.
  • an additional control unit is connected to a line with the actual sensor arrangement.
  • the cable is used for energy transmission to the sensor and for data transmission.
  • an indication of the measurement results can also be made.
  • an object of the invention to provide an advanced device for polarimetric in vivo determination of blood sugar concentration by means of a sensor assembly, a measuring head unit for this and a display unit, which can be worn inconspicuous and the daily life of a subject not restrictive and the others a trouble-free autarkic operation allows.
  • the sensor arrangement comprises
  • a display unit is available.
  • the sensor assembly includes a signal preprocessing unit and a wireless communication assembly with, e.g. watch similar
  • the communication is triggered or established only after checking and confirming an individual identification string which is patient-specific.
  • the display unit has one for wireless communication with the
  • Sensor arrangement suitable air interface and can in addition to a
  • a configuration device which has a
  • Air interface for wireless communication to both the sensor array and the display unit comprises.
  • a calibration is carried out on the basis of comparative measurements of the
  • the sensor arrangement on the one hand, but also the display unit on the other hand have a self-sufficient power supply, in particular by integrated primary or secondary elements. Furthermore, both the sensor arrangement and the display unit have means for attachment to different parts of the body of a subject or acts with such means, e.g.
  • Subjects e.g. on the test person's stomach, and the display unit can be fixed to the wrist like a clock.
  • the display unit or even the sensor arrangement has a memory for detecting the blood sugar over several days to several months. These stored values can also be used for comparison purposes with regard to current measured values and to the aforementioned warning function.
  • the device has self-learning properties.
  • a timer module is provided to then associate detected measured values with a time profile, in particular the daily, weekly or monthly cycle.
  • the timer can have a suitable DCF receiver here, so that errors in the assignment of the measured values to the daily course, e.g. be excluded by incorrect operation, or be limited to manual inputs by the subject to a minimum.
  • the display unit has a symbol representation and / or speech output in order to propose measures for reducing the effects of under- or hypoglycaemia.
  • the symbol representation may e.g. include a stylized candy to encourage an oral sugar intake.
  • At least the display unit is moisture protected or
  • the display unit can have a
  • the display unit in a sleep mode when the display unit is not only worn by the subject, e.g. then, if the case occurs, the clock-like executed
  • Display unit is removed from the wrist.
  • the display unit can also be configured such that, for example, for clinical applications, the data of several patients, ie several sensor arrangements, can be called up and displayed.
  • a further development consists of executing a USB or similar interface in order to display measured values, for example via a software application (app) on a smartphone.
  • the device according to the invention and the secondary elements located in it can be recharged via a charging circuit, wherein the charging circuit is also inductive, i. is wirelessly executable.
  • fast A / D converters are used and optionally several transducers are operated in parallel in order to enable a very fast signal evaluation.
  • the temperature is detected, wherein the measured value detection is activated only above a certain temperature limit in order to obtain significant measurement data.
  • the device according to the invention for non-invasive blood glucose determination therefore consists of two units which are capable of communicating with one another via an air interface.
  • the first unit is to be understood as the sensor arrangement which is designed as a patient-specific measuring head unit.
  • the second unit is the display unit.
  • the necessary measurement results are determined and subjected to signal preprocessing via an integrated processor system.
  • the measuring head unit at least one laser diode and a group of associated receiver diodes, is selectively provided in the range around 850 nm.
  • the integrated processor system With the help of the integrated processor system, a signal preprocessing as well as an integration of a defined number of measured values as well as a plausibility check are performed
  • the corresponding pre-processed data are then transmitted via an air interface preferably in the frequency range of 868 MHz to the evaluation unit.
  • an air interface preferably in the frequency range of 868 MHz.
  • the specific construction of the sensor is based on the desired wearing comfort at a predefined body location, e.g. on the stomach, oriented.
  • the senor is very small and preferably round with low height can be realized.
  • Power is supplied, for example, via a primary cell integrated in the sensor.
  • the sensor can then be attached to the selected defined body part by means of a special patch, belt or the like.
  • the display unit includes a microprocessor for data storage and data display.
  • the display unit can be a trigger for cyclic data acquisition in or by means of the measuring head unit.
  • a calibration of the sensor or the measuring head unit can be performed. It is also possible to perform basic settings of the display unit via the configuration device. Furthermore, there is the possibility of reading the
  • Head unit to assign a plurality of display units, whereby, for.
  • the mother of a diabetic child can monitor which blood sugar levels are currently available to the child.
  • a special measuring head unit has been created which ensures the desired wearing comfort, accommodates the required electrical components and has only a small installation space.
  • a lower housing part and a cap part formed as a housing cover or a deformable cap, wherein a polarizing film can be used in the lower part of the housing in a radiation-permeable window present there.
  • the housing part may alternatively be completely transparent to radiation, but also have the above-mentioned radiation-permeable window section.
  • means for fixing a printed circuit board are designed as wiring carriers, which hold the printed circuit board in such a position-oriented manner that electronic components located on the printed circuit board can transmit radiation through the window and receive reflected radiation for measuring data acquisition in a suitable manner.
  • the relevant in this regard electronic components are at least one laser diode and a predetermined number of grouped on the circuit board receiving diodes.
  • the cap consists according to the invention of an elastic or
  • Properties of the cap can selbge be slipped over a circumferential locking edge of the housing base and connected to the housing base.
  • the circuit board has a slot-shaped contact edge for the aligned at a predetermined angle
  • Receiver diodes is also according to the invention laterally of a
  • This scattered light absorber can out a possible dark, ie non-reflective foam material consist.
  • the polarizing film can be used in a surface recess of the housing lower part, which extends to the inside, in order to simultaneously obtain a fixation and a defined position of the polarizing film.
  • the polarizing film can also surface sections
  • the wall-shaped radiation absorber which from an approximately
  • annular elastic structure may exist, which is mounted on the circuit board, fixed with the insertion of the circuit board at the same time used in the surface recession polarizing film.
  • the lower housing part can still be provided a portion for position-secured recording of the primary or secondary element.
  • the lower housing part is preferably made of a plastic injection molding material and can be manufactured inexpensively with the necessary stops, recesses, recesses and other parts.
  • Fig. 1 is a perspective view of the measuring head unit with a view of the
  • FIG. 2 shows a view of the underside of the measuring head unit
  • FIG. Fig. 3a and 3b is a cross-sectional view of the measuring head unit of Figure 1 with a detailed view of the everting connection between the cap and housing base ( Figure 3b).
  • Fig. 4 is a plan view of the inside of the housing base with
  • Fig. 5 is a perspective view of the polarizing film
  • FIG. 8 is a plan view of the lower housing part with inserted circuit board and the contacting elements for a primary or secondary cell.
  • Fig. 9 shows the top of the circuit board
  • the measuring head unit 1 consists of a lower housing part 2 and a housing upper part designed as a cap third
  • the cap 3 is preferably made of an electrical or elastomeric material. As can be seen in FIG. 3b, the cap 3 can be slipped with its lower edge 31 over a peripheral latching edge 22 of the housing lower part 2, so that a fixed and sealed connection results in this respect.
  • the bottom of the housing is shown symbolically with the Fig. 2.
  • Bottom can be used at least in one area of a
  • Polarizing film 4 (see Fig. 5) be designed to be transparent to radiation or have a radiation-permeable window.
  • the lower housing part 2 is preferably made of a plastic injection-molded material and may have sections 5 for securing the position of a primary or secondary element not shown in the figures.
  • the lower housing part 2 On the inside, the lower housing part 2, as e.g. 4 and 7, stops 6 for a printed circuit board 7 (see Fig. 8 to 10) on.
  • FIG. 5 shows a perspective view of the polarizing film 4, which has a section with a first direction of polarization or plane 41 and a further, inner section with respect thereto
  • Polarization plane or direction 42 has.
  • the polarizing film 4 can be used in a surface recess of the housing 2, as can be clearly seen in the cross-sectional view of FIG. 6.
  • FIG. 7 now shows a view of the housing lower part 2, the polarization film 4 already being used here in the region of the radiation-permeable window 8.
  • the formation of the housing base 2 can be made such that a protruding edge 23 is present, the attachment of the measuring head unit 1, for example with an adhesive ring on a selected body portion of the subject serves or supports such attachment.
  • FIG. 8 shows the printed circuit board 7 inserted into the housing lower part 2 with symbolically indicated components, such as e.g. a microprocessor 71, an energy storage capacity 72 and other components.
  • components such as e.g. a microprocessor 71, an energy storage capacity 72 and other components.
  • a slot-shaped opening 73 formed as a slot-shaped contact edge, serves to fix the laser diode 74, which can be seen in FIG. 10, at a defined angle.
  • an edge 75 of the laser diode 74 dips into the slot 73 and provides the desired position.
  • the underside of the printed circuit board 7 facing the radiation-permeable window 8 or the polarizing film 4 receives a group of radiation-sensitive diodes 76.
  • This group of radiation-sensitive diodes 76 is laterally surrounded by a wall-shaped scattered light absorber 9.
  • This scattered light absorber 9 prevents the unwanted influencing of the radiation-sensitive diodes 76 and largely excludes a falsification of the measurement results.
  • Contacting elements 77 attached, which electrically connect the primary element not shown in the figures and thus ensure the supply of operating voltage.
  • the entire structure of the measuring head unit can be seen with a view to the
  • the lower housing part 2 has the aforementioned radiation-permeable window 8.
  • Housing base inside the corresponding stops 6 for the circuit board 7 are present.
  • Window 8 is a surface recess available, which serves to receive a circular in the example shown polarizing film 4.
  • the polarizing film 4 has an angular cutout 41, which allows unimpeded passage of laser radiation, starting from the laser diode 74.
  • the printed circuit board 7 with radiation absorber 9 is then directionally correct, i. with the radiation-sensitive elements 76 down into the
  • Housing base 2 used.
  • An insulating cover plate 10 is fixed above the printed circuit board 7.
  • the measuring head unit After insertion of the primary or secondary element, not shown in FIG. 11, the measuring head unit is ready for operation. Slipping over the cap 3 made of elastic or elastomeric material while gripping the edge or the peripheral edge 2, the measuring head unit is secured and sealed with respect to environmental influences when used as intended.

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

Abstract

L'invention concerne un dispositif de détermination polarimétrique de la glycémie in vivo au moyen d'un système de détection comprenant au moins une diode à semi-conducteur émettant un rayonnement ainsi qu'au moins un groupe de diodes à semi-conducteur sensibles au rayonnement, servant à analyser les variations de la polarisation dues au taux de glucose sanguin, et un module d'affichage. Selon l'invention, le système de détection comprend un module de traitement du signal ainsi qu'un sous-ensemble de communication sans fil avec le module d'affichage, la communication étant déclenchée ou établie seulement après qu'une suite individuelle de caractères d'identification a été vérifiée et confirmée. Le module d'affichage possède une interface aérienne adaptée à la communication sans fil avec le système de détection et, en plus d'une fonction d'alerte de glycémie, il comporte un affichage de tendance. Le dispositif comporte en outre un système de configuration comprenant une interface aérienne de communication sans fil avec le système de détection ainsi qu'avec le module d'affichage. Ce système de configuration permet d'effectuer un étalonnage sur la base de mesures comparatives de la glycémie.
EP13712708.0A 2012-05-16 2013-03-11 Dispositif de détermination polarimétrique de la glycémie in vivo Withdrawn EP2849647A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102012009872 2012-05-16
PCT/EP2013/054827 WO2013170974A1 (fr) 2012-05-16 2013-03-11 Dispositif de détermination polarimétrique de la glycémie in vivo

Publications (1)

Publication Number Publication Date
EP2849647A1 true EP2849647A1 (fr) 2015-03-25

Family

ID=48013933

Family Applications (1)

Application Number Title Priority Date Filing Date
EP13712708.0A Withdrawn EP2849647A1 (fr) 2012-05-16 2013-03-11 Dispositif de détermination polarimétrique de la glycémie in vivo

Country Status (2)

Country Link
EP (1) EP2849647A1 (fr)
WO (1) WO2013170974A1 (fr)

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19519051B4 (de) 1995-05-24 2007-05-03 Diabetic Trust Ag Verfahren und Vorrichtung zur polarimetrischen Bestimmung der Blutzuckerkonzentration
US6253097B1 (en) * 1996-03-06 2001-06-26 Datex-Ohmeda, Inc. Noninvasive medical monitoring instrument using surface emitting laser devices
US6175752B1 (en) * 1998-04-30 2001-01-16 Therasense, Inc. Analyte monitoring device and methods of use
IL138884A (en) * 2000-10-05 2006-07-05 Conmed Corp Pulse oximeter and a method of its operation
DE102008023725B4 (de) 2008-05-15 2011-11-17 Tic Medizintechnik Gmbh & Co. Kg Verfahren und Vorrichtung zur nichtinvasiven Blutzuckermessung
DE102010014775A1 (de) 2010-04-13 2011-10-13 Vivantum Gmbh Vorrichtung und Verfahren zur Bestimmen eines biologischen, chemischen und/oder physikalischen Parameters in lebendem biologischem Gewebe
US10231653B2 (en) * 2010-09-29 2019-03-19 Dexcom, Inc. Advanced continuous analyte monitoring system
DE102010041775B4 (de) 2010-09-30 2015-07-09 Siemens Medical Instruments Pte. Ltd. Verfahren zum Anpassen einer Hörvorrichtung mit Perzentilanalyse und Anpassvorrichtung

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2013170974A1 *

Also Published As

Publication number Publication date
WO2013170974A1 (fr) 2013-11-21

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