WO2004103170A1 - A glucose measuring device - Google Patents

A glucose measuring device Download PDF

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Publication number
WO2004103170A1
WO2004103170A1 PCT/DK2004/000350 DK2004000350W WO2004103170A1 WO 2004103170 A1 WO2004103170 A1 WO 2004103170A1 DK 2004000350 W DK2004000350 W DK 2004000350W WO 2004103170 A1 WO2004103170 A1 WO 2004103170A1
Authority
WO
WIPO (PCT)
Prior art keywords
glucose
measuring device
characterized
glucose measuring
according
Prior art date
Application number
PCT/DK2004/000350
Other languages
French (fr)
Inventor
Rasmus Panduro
Original Assignee
Novo Nordisk A/S
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
Priority to DKPA200300772 priority Critical
Priority to DKPA200300772 priority
Priority to US47591603P priority
Priority to US60/475,916 priority
Application filed by Novo Nordisk A/S filed Critical Novo Nordisk A/S
Publication of WO2004103170A1 publication Critical patent/WO2004103170A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements 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
    • A61B5/683Means for maintaining contact with the body
    • A61B5/6832Means for maintaining contact with the body using adhesives
    • A61B5/6833Adhesive patches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14503Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1495Calibrating or testing of in-vivo probes
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/4875Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848Needles
    • A61B5/6849Needles in combination with a needle set

Abstract

A glucose measuring device for continues glucose measurement is disclosed. In order to regularly calibrate the enclosed sensor, a plurality of openings is provided. Calibration is easily done by delivering a minute amount of bodily fluid through the opening to a measuring probe located within the housing. Adequate means are provided for informing the user on which openings has been used. In this way the user is visually informed on when the last calibration was performed.

Description

A Glucose Measuring Device

THE TECHNICAL FIELD OF THE INVENTION:

The invention relates to a glucose measuring device for continues glucose measurement of the type comprising a trans-dermal sensor. The sensor is connected to an electronics package which communicates the measured glucose levels to a microprocessor.

DESCRIPTION OF RELATED ART:

The signal from a glucose sensor which is semi-permanently inserted into the tissue of a human body is subject to change over time. The rate of signal change depend on various factors such as fouling of the polymer membrane, immune response for instance by encapsulation and degradation of the enzyme used for glucose detection. Due to the variation in sensor response it is necessary to calibrate the glucose sensor within suitable intervals.

WO 01/52727 discloses a glucose sensor insertable into the subcutaneous layer of a human body. The sensor is connected to a transmitter which transmits the measured values to a remote located blood glucose meter. In order to calibrate the sensor a electrochemical strip for holding a blood sample is brought into contact with a measuring probe communicating with a microprocessor. As blood is applied to the electrochemical strip, the measuring probe inside the blood glucose meter measures the content of glucose in the blood sample located on electrochemical strip and the microprocessor carries out the calibration.

DESCRIPTION OF THE INVENTION:

A problem of the prior art is that it is not possible by looking at the glucose measuring device to determined whether or not the necessary calibration has been carried out. The user must actively switch on the blood glucose meter in order to check when the last calibration was done. This is usually displayed in the display of the blood glucose meter once activated. To operate a blood glucose meter, an electrochemical strip is docked in the blood glucose meter, and a small amount of blood or other bodily fluid is applied to the electrochemical strip. The electronics integrated in the blood glucose meter then uses a signal generated by the electrochemical strip to calculate the present blood glucose level.

The object of the present invention is to provide a glucose measuring devices for continuous glucose monitoring which includes a visible indicator indicating whether calibration has been done or not.

This object is obtained by a glucose measuring device according to claim 1.

The measuring probes for calibrating the glucose sensor is provided inside the housing and access to the measuring probes are provided through a number of openings. When ever calibration is done the user delivers a sample of a bodily fluid such as blood to one of the measuring probes through one of the openings in the housing. When looking at the glucose measuring device it will be apparent which openings have been used and which has not due to remains of the bodily fluid in and around the opening. In this very simple manner the user is constantly provided with a visible indication on the calibration status.

According to an embodiment of the invention each opening is covered by a removable barrier which most be removed before accessing the opening. Due to the missing barrier it will be apparent for any user that the particular opening has been used.

If the barrier is a peel foil as mentioned in claim 3 it will be easily removable.

In addition to, or instead of, a removable barrier, the glucose measuring device could in a more advanced embodiment be provided with active indication means located adjacent each opening. In this way a user is provided with an active indication if an opening, and the measuring probe in the particular opening has been used.

The active indication means could in an embodiment of the invention be an electric lamp such as a LED lamp which is activated once a measuring probe has been used.

According to an embodiment of the invention, the housing comprises a top surface, a bottom surface and a sidewall there between. The openings through which the bodily fluid is brought into contact with one of the measuring probes are preferably provided in the sidewall. Due to this solution the device can be produced with a rather low height which makes it more comfortable to wear on the surface of the body.

In the alternative embodiment, the openings are provided in a rotatable cover which is located in the top surface of the housing. Due to this design there need only be one measuring probe in the housing since each opening are brought into alignment with the measuring probe one at the time by rotating the rotatable cover.

As defined, each opening could be marked with a marking indicating the sequence in which calibration is to be done. This marking could in a simple form be a numeric number, or it could be an indication showing the user the number of hours after first use the device needs calibration.

BRIEF DESCRIPTION OF THE DRAWINGS:

The invention will be explained more fully below in connection with a preferred embodiment and with reference to the drawings in which:

Figure 1 shows a perspective view of one embodiment of a glucose measuring device according to the invention

Figure 2 shows an exploded view of the glucose measuring device of figure 1.

Figure 3 shows the operation of the lancet.

Figure 4 shows a sectional side view of a second embodiment of the glucose measuring device according to the invention.

Figure 5 shows a sectional top view of an embodiment similar to that shown in figure

4.

Figure 6 shows a perspective view of another embodiment of the glucose measuring device according to the invention. The figures are schematic and simplified for clarity, and they just show details, which are essential to the understanding of the invention, while other details are left out. Throughout, the same reference numerals are used for identical or corresponding parts.

DETAILED DESCRIPTION OF EMBODIMENT:

Figure 1 show a glucose measuring device 1 carried on a skin contacting layer 2 which layer 2 on the side pointing towards the skin of the user carries an adhesive coating 3. The glucose measuring device 1 comprises a disposable part 5 connected to a durable part 6. The function of the flexible adhesive 3 is to fix the assembly comprising of the disposable part 5 and the durable part 2 to the skin of the user, all though the glucose measuring device could be worn separate from the body if wanted

The durable part 6 comprises not shown means for wireless communication with an auxiliary unit. The disposable part 5 comprises a number of measuring probes 13 as will be explained. The microprocessor is in this embodiment shown as being located in the disposable part 6 but could as well be located in the durable part 5. Once the disposable part 5 is used it is disposed of and the durable part 6 is removed and connected to a new disposable part 5. Instead of providing the glucose measuring device as a disposable part 5 and a durable part 6, the entire device could be fitted into only one part which would then be disposed of after use.

The glucose measuring device 1 is covered by a sticker 4 which is adhered to the glucose measuring device 1. The sticker 4 serves different purposes. As the sticker 4 adheres to both the disposable part 5 and to the durable part 6, it secures the disposable part 5 and the durable part 6 together. Further the durable part 6 can have an aperture 7 which fits with a protruding part 8 protruding from the disposable part 5.

The sticker 4 also has a plurality of appendixes 9, each appendix 9 covering an opening 12 in the disposable part 2. Inside the disposable part 2 a number of measuring probes 13 are provided. Each measuring probe 13 is preferably a sensor for measuring the content of glucose in blood. The measurement is preferably carried out by electrochemical means, using a reaction scheme based on measurement of hydrogen peroxide formed in an enzymatic reaction involving the glucose in the blood sample and oxygen.

The measuring probes 13 can be of the type which measures the glucose level in a blood sample located on an electrochemical strip which electrochemical strip is either permanently connected to the measuring probe 13 or connectable to the measuring probe 13 at the user's discretion.

The measuring probe 13 could alternatively be a measuring cell of well known type, e.g. a type that works without a strip or a type with a build-in strip.

The measuring probes could either be located in the proximity of the top surface 17 as indi- cated in figure 4 or in the proximity of the sidewall 19 as indicated in figure 5.

For using the measuring probes 13 a minute amount of blood is needed. The blood is conveniently extracted by pricking the finger 11 of the user utilizing a lancet 10 stored in the appendix 9 of the sticker 4.

The microprocessor 14 shown in figure 4 and figure 5 is furthermore connected to a trans- dermal sensor 15. The sensor 15 is preferably a well know glucose sensor which is placed at a selected site within the body of the user and which continuously measures the glucose concentration of the users blood or other bodily fluid.

In using the glucose measuring device 1, the glucose measuring device 1 is adhered to the body of the user with the glucose sensor 15 inserted through the users skin and into the subcutaneous layer of the body. When activated the glucose sensor 15 continuously measures the glucose concentration in a bodily fluid of the user.

As the response of the glucose sensor 15 varies during use, regularly recalibration is needed. Recalibration is done by a measurement of the blood glucose content of the user and subsequently comparing this value to the value measured by the sensor 15. The measurement as well as the recalibration is in an embodiment of the invention carried out auto- matically by the microprocessor 14. The recalibration is carried out by tearing one of the appendixes 9 of the sticker 4 such that a lancet 10 is made available, and an opening 12 in the housing is exposed. A sample of blood is brought into contact with one of the measuring probes 13 located within the housing 16 of the transcutaneous glucose measuring device 1. When the measuring probe 13 and the microprocessor 14 detects the glucose concentration of the blood, the microprocessor automatically calibrates the device accordingly.

Recalibration is preferably carried out every eight hour, each time using a new opening 12 in the disposable part 6. Since a glucose sensor 15 is usually carried by the user for approximately 72 hours, there would normally be eight such openings 12 and eight probes 13 inside the disposable part 6.

Each opening 12 are numbered with a number 20 or other visual sign indicating the order in which the different openings 12 should be used. The number 20 is preferably located on the appendix 9.

In an alternative embodiment, the visual indicating means could be active such as an LED lamp 21. The LED lamp 21 could provide the user with a signal such as a blinking when it was time to calibrate the glucose measuring device, and a permanent light when the calibration is done. Other combinations of signal could off cause be used as well.

In an alternative embodiment of the glucose measuring device 30 shown in figure 6 a rotatable cover 31 is mounted on the housing 32. The cover 31 is provided with a plurality of openings 33. A single not shown measuring probe is provided inside the housing 32, and the blood sample is brought into contact with the probe through the opening 33 when the opening 33 is located above the measuring probe. The position of the measuring probe is indicated with a marker 34 on the housing. Each opening 33 are marked with a number 35 indicating when each opening 33 should be used for calibrating the glucose measuring device 30. In this way the user of the glucose measuring device 30 can keep track of the calibration routine.

Some preferred embodiments have been shown in the foregoing, but it should be stressed that the invention is not limited to these, but may be embodied in other ways within the sub- ject matter defined in the following claims.

Claims

CLAIMS:
1. A glucose measuring device (1 , 30) for continues glucose measurement comprising a glucose sensor (15) for contacting a first bodily fluid which glucose sensor (15) communicates with a microprocessor (14), and at least one measuring probe (13) communicating with the microprocessor (14) for calibrating the glucose sensor (15),
characterized in that, the glucose measuring device comprises a housing (16, 32) adapted with a plurality of openings (12, 33) through which openings (12, 33) a second bodily fluid can be brought into contact with one of the measuring probes (13) located inside the housing (16, 32).
2. A glucose measuring device (1 , 30) according to claim 1 , characterized in that, each opening (12, 33) is covered by a removable barrier (9).
3. A glucose measuring device (1 , 30) according to claim 2, characterized in that the removable barrier (9) is a peel foil.
4. A glucose measuring device (1 , 30) according to claim 1 , characterized in that active indi- cator means are located adjacent each opening (12, 33).
5. A glucose measuring device (1 , 30) according to claim 4, characterized in that the indicator means is an electric lamp such as an LED lamp (21).
6. A glucose measuring device (1 , 30) according to anyone of the claims 1 to 5, characterized in that, the housing (16, 33) comprises a top surface (17), a bottom surface (18) and a sidewall (19) there between.
7. A glucose measuring device (1 , 30) according to claim 6, characterized in that, the open- ings (12, 33) is provided in the sidewall (19).
8. A glucose measuring device (1 , 30) according to claim 6, characterized in that, the openings (33) are provided in a rotatable cover (31) located in the top surface (17) of the housing (32).
9. A glucose measuring device according to any one of the claims 1 to 8, characterized in that, each opening (12, 33) are marked with a marking (20, 35) indicating the sequence in which calibration is to be done.
PCT/DK2004/000350 2003-05-22 2004-05-18 A glucose measuring device WO2004103170A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
DKPA200300772 2003-05-22
DKPA200300772 2003-05-22
US47591603P true 2003-06-04 2003-06-04
US60/475,916 2003-06-04

Publications (1)

Publication Number Publication Date
WO2004103170A1 true WO2004103170A1 (en) 2004-12-02

Family

ID=33477542

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DK2004/000350 WO2004103170A1 (en) 2003-05-22 2004-05-18 A glucose measuring device

Country Status (1)

Country Link
WO (1) WO2004103170A1 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009154675A2 (en) * 2008-05-28 2009-12-23 Medtronic Minimed, Inc. Needle protective device for subcutaneous sensors
US10478102B2 (en) 2018-06-01 2019-11-19 Medtronic Minimed, Inc. Needle protective device for subcutaneous sensors

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5507288A (en) * 1994-05-05 1996-04-16 Boehringer Mannheim Gmbh Analytical system for monitoring a substance to be analyzed in patient-blood
WO2000078210A1 (en) * 1999-06-17 2000-12-28 Minimed Inc. Characteristic monitor system for use with analyte sensor
WO2001052727A1 (en) * 2000-01-20 2001-07-26 Minimed Inc. Handheld personal data assistant (pda) with a medical device and method of using the same

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5507288A (en) * 1994-05-05 1996-04-16 Boehringer Mannheim Gmbh Analytical system for monitoring a substance to be analyzed in patient-blood
US5507288B1 (en) * 1994-05-05 1997-07-08 Boehringer Mannheim Gmbh Analytical system for monitoring a substance to be analyzed in patient-blood
WO2000078210A1 (en) * 1999-06-17 2000-12-28 Minimed Inc. Characteristic monitor system for use with analyte sensor
WO2001052727A1 (en) * 2000-01-20 2001-07-26 Minimed Inc. Handheld personal data assistant (pda) with a medical device and method of using the same

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009154675A2 (en) * 2008-05-28 2009-12-23 Medtronic Minimed, Inc. Needle protective device for subcutaneous sensors
WO2009154675A3 (en) * 2008-05-28 2010-03-04 Medtronic Minimed, Inc. Needle protective device for subcutaneous sensors
US9295786B2 (en) 2008-05-28 2016-03-29 Medtronic Minimed, Inc. Needle protective device for subcutaneous sensors
US10010275B2 (en) 2008-05-28 2018-07-03 Medtronic Minimed, Inc. Needle protective device for subcutaneous sensors
US10478102B2 (en) 2018-06-01 2019-11-19 Medtronic Minimed, Inc. Needle protective device for subcutaneous sensors

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