WO2008078128A1 - A portable blood analyzer for measuring the level of at least one compound contained in the blood of a patient - Google Patents

A portable blood analyzer for measuring the level of at least one compound contained in the blood of a patient Download PDF

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Publication number
WO2008078128A1
WO2008078128A1 PCT/IB2006/003772 IB2006003772W WO2008078128A1 WO 2008078128 A1 WO2008078128 A1 WO 2008078128A1 IB 2006003772 W IB2006003772 W IB 2006003772W WO 2008078128 A1 WO2008078128 A1 WO 2008078128A1
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WO
WIPO (PCT)
Prior art keywords
blood
unit
measuring sensor
concentration
analyser
Prior art date
Application number
PCT/IB2006/003772
Other languages
French (fr)
Inventor
Alain Chemla
Anthony Guchet
Michael Sillam
Original Assignee
Chinasia Products Ltd
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 Chinasia Products Ltd filed Critical Chinasia Products Ltd
Priority to PCT/IB2006/003772 priority Critical patent/WO2008078128A1/en
Publication of WO2008078128A1 publication Critical patent/WO2008078128A1/en

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/48785—Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
    • 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
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157

Abstract

The blood analyser (10) comprises a blood measuring sensor (26) for measuring the concentration of the compound in a sample of blood of the patient and a display unit (18) for displaying the concentration measured by the measuring sensor (26). It further comprises an illuminating unit (20) able to be lit in at least two different states depending on the value of the compound concentration measured by the measuring sensor (26). Application to the measurement of glucose or cholesterol concentration in the blood of a user.

Description

A portable blood analyzer for measuring the level of at least one compound contained in the blood of a patient
BACKGROUND OF THE INVENTION Field of the Invention The present invention relates to a portable blood analyser for measuring the concentration of at least one compound contained in the blood of a patient, the blood analyser comprising a blood measuring sensor for measuring the concentration of the compound in a sample of blood from the patient and a display unit for displaying the concentration measured by the measuring sensor. This invention applies for example to the detection of glucose or cholesterol concentration in the blood of a patient. Description of the Related Art
For patients suffering from diabetes, the level of glucose in the blood has to be checked several times every day in order to ensure a control of the glucose in the blood. It is very important for diabetics to adjust the level of glucose as soon as any variation is detected.
Known portable blood glucose analysers indicate the level of glucose in the blood of a patient by displaying on a screen a value corresponding to the concentration in glucose. The patient can then check if the value is normal or not, according to standard values.
However, these glucose analysers are not always convenient to use, e.g. in the dark or by elderly patients or by patients without medical knowledge.
SUMMARY OF THE INVENTION
In view of the shortcomings of the traditional portable blood analysers, the present invention aims at providing a portable blood analyser that can be used easily and accurately under any conditions.
Accordingly, the subject matter of the invention is a portable blood analyser as described above, characterized in that it further comprises an illuminating unit able to be lit in at least two different states depending on the value of the concentration measured by the measuring sensor.
The portable blood analyser according to the invention may comprise one or more of the following features: - the light generated by the illuminating unit is focused on the display unit to allow the compound concentration displayed on the display unit to be read in the dark when the illuminating unit is active ;
- the illuminating unit comprises a backlight unit able to light the display unit in at least two different colors corresponding respectively to each of the different states of the illuminating unit ;
- it comprises a controller operatively connected to the measuring sensor and the illuminating unit, the controller comprising:
- a memory for storing at least a first and a second ranges of concentrations of the compound in the patient blood; - a comparator for determining the range in which the blood glucose concentration measured by the measuring sensor is located;
- a control unit for selectively illuminating the illuminating unit in a first state when the comparator determines that the concentration measured by the measuring sensor is located in a first range, and in a second state distinct from the first state when the comparator determines that the concentration measured by the measuring sensor is located in a second range ;
- the illuminating unit is able to illuminate the display unit in at least three different states depending on the value of compound concentration measured by the measuring sensor ;
- it comprises an acoustic unit for emitting at least two different acoustic signals corresponding respectively to each different state of the illuminating unit ;
- the or each acoustic signal is a voice message ; - it comprises a blood holding stripe receptacle, the blood measuring sensor being able to measure the concentration of the compound in the blood contained in a stripe placed in the blood holding stripe receptacle ; - the compound is chosen among glucose or cholesterol ; and
- it further comprises a start key for activating the controller, the display unit and the illuminating unit.
Accordingly, the blood analyser according to the invention provides clearer information to the patient using different lighting colours on the screen directly, adding or not some voice to inform the patient about his health condition and action to be taken.
These blood analysers are for medical use and allow users to check easily the level of a compound, e.g. glucose, in their blood by checking the color of the screen that displays the result, based on standard values or ranges set in the blood glucose analyser to define glucose level of the patient. The patient can then check his condition only by looking at the different colors provided by the backlight module of the unit.
The primary advantage of the present invention is to provide instantly a clear and easy reading of the result from the patient and to help the user and/or the relatives to evaluate the patient condition by simply looking at the color for the screen. For glucose concentration analysis, six major conditions for the patient can be checked according to his glucose level:
- first range between 0.80 g/l and 1.20 g/l: glucose level is normal, and screen is turning in green;
- second range between 0.45 g/l and 0.80 g/l, glucose level is low, and screen is turning in orange;
- third range between 0 g/l and 0.45 g/l, glucose level is very low, and screen is turning in red; - fourth range between 1.20g/l and 1.80 g/l, glucose level is slightly high and screen is turning in orange;
- fifth range between 1.80 g/l and 2.40 g/l, glucose level is medium high and screen is turning in red;
- sixth range above 2.40 g/l : glucose level is very high, and screen is turning in red and flashing. Another advantage of the invention is to allow the user to use the blood glucose analyser in dark places while still being able to see easily the results, without having to turn on any lighting.
A further advantage of the present invention is, by coupling this lighting LCD feature with the talking features to enhance the quality of the information given to the patient by providing the results by a voice message
(for blind people for example) and for example, to provide a special voice message warning the patient about his condition.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be better understood upon reading of the following description, given only as an example, and made in reference to the following drawings in which :
- Figure 1 is a face view of a first portable glucose analyser according to the present invention;
- Figure 2 is a flow chart of a process for using the glucose analyser of Figure 1 ; and
- Figure 3 is a face view of a second portable glucose analyser according to the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Portable blood analyzers according to the invention apply to the measurement of the concentration of at least one compound contained in the blood of a patient, after a sample of blood of the patient has been taken. The compound to be tested is for example glucose, in the case of patients suffering from diabetes, or cholesterol.
A first portable blood analyser 10 according to the invention is disclosed in Figures 1 and 2. This blood analyser 10 is for example a blood glucose analyser for measuring the concentration of glucose contained in a blood of a patient several times during the course of a day.
The blood glucose analyser 10 comprises a portable casing 12 holding a blood measuring unit 14, a controller 16, and a display unit 18. According to the invention, the blood glucose analyser 10 further comprises an illuminating unit 20 for illuminating the display unit 18 in at least two different states depending on the glucose concentration measured in unit 14, and an acoustic unit 22 for emitting at least two different voice messages depending on the concentration measured by unit 14.
The casing 12 is portable by hand by a patient. The patient can carry the casing 12 permanently with him.
The blood measuring unit 14 is housed in the portable casing 12. It comprises a sample receptacle 24, and a blood measuring sensor 26 placed in register with the sample receptacle 24 to be able to measure a sample of blood from the patient when this sample is introduced in the sample receptacle 24.
The sample receptacle 24 is defined by a slot 27 opening out of the casing 12. Slot 27 is able to receive a corresponding sample holder strip 28 able to hold a drop of blood from the patient.
The sample strip 28 is movable with regard to the casing 12 between a blood loading position, located away from the casing 12, and a measuring position, in which the strip 28 is inserted in the slot 27 for being measured by the blood measuring sensor 26. The blood measuring sensor 26 is placed in the vicinity of the slot 27.
It comprises for example a chemical and/or an electrochemical contact sensor.
The blood measuring sensor 26 is able to produce an electrical signal significant of the concentration of glucose in a sample of blood placed on the strip 28, when the strip 28 is lodged in the slot 27.
The controller 16 comprises a memory 30, a comparator 32, and an activation device 34 connected to the comparator 32 and the memory 30.
The memory 30 stores at least two ranges of glucose concentrations which can be set while manufacturing the blood analyser 10, or which can be set later by a user.
In the present example, the memory 30 stores six ranges of glucose concentrations, i.e, a first range between 0.80 g/l and 1.20 g/l for normal glucose concentration, a second range between 0.45 g/l and 0.80 g/l, for low glucose concentration, a third range between 0 g/l and 0.45 g/l, for very low glucose concentration, a fourth range between 1.20g/l and 1.80 g/l, for slightly high glucose concentration, a fifth range between 1.80 g/l and 2.40 g/l, for medium high glucose concentration and a sixth range above 2.40 g/l : for very high glucose concentration.
The comparator 32 is connected to the activation unit 34, to the memory 30, and to the blood measuring sensor 26. It is also connected to the display unit 18 and the illuminating unit 20. The comparator 32 is able to convert the electrical information signal received from the blood measuring sensor 26 into a value of glucose concentration in the blood and to control the display unit 18 to display this value on the display unit 18.
The comparator 32 is also able to compare the value measured by the blood measuring sensor 26 with the ranges stored in the memory 30 to determine in which range the value measured by the measuring sensor 26 is located.
Based on the result of this determination, the comparator 32 is able to control the illuminating unit 20 to illuminate the unit 20 in at least two different states depending on the result of the determination and to control the acoustic unit 22 to produce at least two different voice messages depending on the result of the determination.
The activating unit 34 is connected to a detector (not shown) located in the slot 27, which detects the presence of a strip 28 in the slot 27. Upon introduction of a strip 28 in the slot 27, the activating unit 34 activates the measuring sensor 26 and the comparator unit 32 to produce the display of the value measured by the sensor 26 on the display unit 18, the selective illumination of a display unit 18 by the illuminating unit 20, and also the emission of a voice message from the acoustic unit 22. The display unit 20 is composed of a LCD screen placed in an opening defined in the casing 12. The LCD screen is able to display digitally the value of concentration measured by the blood measuring sensor 26, as converted by the comparator 32.
The illuminating unit 20 comprises a backlight device 36 comprising at least three LED of different colors, e.g. a green LED 38A, a red LED 38B and an orange LED 38C. In this example, the light produced by LEDs 38A to
38C is focused on the LCD screen to illuminate this screen and provide a colored background for the displayed results.
In the present example, four distinct states of the illuminating unit 20 are defined. Each state is associated with at least one of the six ranges stored in memory 30.
The controller 16 is able to light selectively each of the LEDs 38A to 38C in a continuous manner, or with flashing, depending on the range in which the value of glucose concentration measured by the blood measuring sensor 26 is located, as determined by the comparator 32. The different states of the illuminating unit are defined by different colors produced by selectively lighting the LEDs 38A to 38C and/or by the continuous or discontinuous lighting of each LED 38A to 38C.
The acoustic unit 22 comprises a speaker 40 placed on the casing 12, and means 42 for storing at least two different voice messages to be produced by the speaker 40. In the present example, the means 42 comprise at least six distinct messages, each corresponding to one range stored in memory 30.
The blood analyser 10 further comprises a repeat key 50. The repeat key 50 allows the user to repeat the display of the results of a measurement on the display unit 18 or to access glucose data that were stored in the memory 30 in previous measurements.
It also comprises a power unit 52 connected to the controller 16 and the repeat key 50.
A setup key 54 is also provided on the casing 18 to activate the controller 16 and set up parameters in the controller 16.
The operation of the first blood analyser according to the invention will now be described in reference to Figures 1 and 2. In use, when a glucose concentration evaluation is requested by a patient (step 70), the patient places a drop of blood on a sample strip 28. The patient then introduces the strip 28 holding the drop of blood in the slot 27 defined in the casing 12. Upon introduction of the strip 28 in the slot (step 72), the activation device 34 detects the presence of a strip 28 in the slot 27 and activates the blood measuring sensor 26, the comparator 32, and the memory 30.
In step 74, the blood measuring sensor 26 produces a signal significant of the glucose concentration in the patient drop of blood, which signal is transmitted to the comparator 32.
In step 76, the comparator 32 subsequently converts the signal received from the blood measuring sensor 26 into a value of glucose concentration in the patient blood, and displays the converted value on the display unit 18. Additionally, in step 78, the comparator 32 compares the value measured by the blood measuring sensor 26 to the ranges stored in the memory 30, in order to determine in which range the glucose concentration is located (step 80).
If, according to step 82, the value of glucose concentration measured by the sensor 26 is located in the first range between 0.80 g/l and 1.20 g/l, as determined by comparator 32, the controller 16 activates the green LED
38A to light up in green the LCD screen of the display unit 18 continuously, thereby defining a first state of the illuminating unit 20.
The controller 16 also activates the acoustic unit 22 to emit a first voice message stored in the means for storing 42, which indicates to the patient that the measured blood glucose concentration is normal.
If, according to step 84, the value of glucose concentration measured by the measuring unit 26 is in the second range between 0.45g/l and 0.80g/l or in the fourth range between 1.20 g/l and 1.80g/l, as determined by comparator 32, the controller 16 activates the orange LED 38C to light up the display unit 18 in a second state distinct from the first state, in which the LCD screen is lit up continuously in orange. The controller 16 also activates the acoustic unit 22 to emit a second voice message stored in the means 42 for storing which indicates to the patient that the measured blood glucose concentration is low, if the glucose concentration is in the second range. If the glucose concentration is in the fourth range, the acoustic unit 22 emits a third voice message to indicate the glucose concentration is slightly high.
If, according to step 86, the value of the glucose concentration by the measuring unit 26 is in the third range between 0 g/l and 0.45 g/l, or in the fifth range between 1.80 g/l and 2.40 g/l as determined by comparator 32, the controller 16 activates the red LED 38B of the illuminating unit 20 to illuminate the display unit in a third state distinct from the first and second state. In this third state, the LED 38D continuously lights up the LCD screen in red.
The controller 16 also activates the acoustic unit 22 to emit a fourth voice message stored in the means for storing 42, which indicates that the glucose concentration is very low, if the glucose concentration is in the third range. If the glucose concentration is in the fifth range, the acoustic unit 22 emits a fifth voice message to indicate the glucose concentration is medium high. If, according to step 88, the value of the glucose concentration measured by sensor 26 is in the sixth range above 2.40 g/l, as determined by comparator 32, the controller 16 activates the red LED 38D in a fourth state distinct from the first, second and third states. In this fourth state, the red LED 38D blinks and illuminates in a discontinuous manner the LCD screen in red.
The controller 16 also activates the acoustic unit 22 to emit a sixth voice message stored in the means for storing 42, which indicates that the glucose concentration is very high.
Thanks to the invention described above, a patient is able to obtain easily and quickly not only the concentration of at least one compound in his blood, but also an indication of the normality of this concentration according to selected ranges. Patients with no medical knowledge or poor abilities can estimate if the concentration is normal or if further action, e.g. calling a nurse or medical doctor must be taken.
The use of an acoustic unit 22 provides blind people with an access to the same information. The selective lighting of the display unit 18 by the illuminating unit 20 allows the use of the analyzer in poor lighting or in the dark.
In a variation shown in Figure 3, the portable blood analyser 10 does not comprise an acoustic unit 22. The information of the patient is then provided only by the selective illumination of the display unit 18 by different states of the illuminating unit 20.
In another variation, the illumination produced by the illuminating unit 20 does not backlight the display unit 18. In this variation, the illuminating unit 20 is for example composed of three LED 38A to 38C which protrude out of the casing 12 at a distance from the LCD screen. In another variation (not shown), the activation device 34 is connected to an activation key which is accessible on the surface of the casing 12. The user then manually activates the activation device 34 by pressing this additional key in order to start a measurement by the analyzer 10.
In another variation, the blood portable device is a blood cholesterol analyser. The blood measuring sensor 26 is able to measure the concentration of cholesterol in a blood sample introduced in the slot 27.
In another variation, the blood portable analyser is able to measure both cholesterol and glucose.
In another variation, the portable blood analyser 10 is used for diabetes screening.
In this case, there are only three ranges stored in the memory 30, i.e:
- a first range below 0.80 g/l in which the glucose concentration is too low;
- a second range between 0.80 g/l and 1.20 g/l in which the glucose concentration is normal and no further test is needed;
- a third range above 1.20 g/l in which the glucose concentration is too high and the user has to undergo further testing. Three distinct associated states of the illuminating unit 20, e.g. three distinct colors, correspond respectively to the three ranges stored in memory 30 for the selective illumination of the display unit 18.

Claims

WHAT IS CLAIMED IS:
1. A portable blood analyser (10) for measuring the concentration of at least one compound contained in the blood of a patient, the blood analyser (10) comprising: - a blood measuring sensor (26) for measuring the concentration of the compound in a sample of blood from the patient ; and
- a display unit (18) for displaying the concentration measured by the measuring sensor (26), characterized, in that it further comprises:
- an illuminating unit (20) able to be lit in at least two different states depending on the value of the concentration measured by the measuring sensor (26).
2. A portable blood analyser (10) according to claim 1 , characterized in that the light generated by the illuminating unit (20) is focused on the display unit (18) to allow the compound concentration displayed on the display unit (18) to be read in the dark when the illuminating unit (20) is active.
3. A portable blood analyser (10) according to claim 1 or 2, characterized in that the illuminating unit (20) comprises a backlight unit able to light the display unit (18) in at least two different colors corresponding respectively to each of the different states of the illuminating unit (20).
4. A portable blood analyser (10) according to any of claims 1 to 3, characterized in that it comprises a controller (16) operatively connected to the measuring sensor (26) and the illuminating unit (20), the controller (16) comprising: - a memory (30) for storing at least a first and a second ranges of concentrations of the compound in the patient blood;
- a comparator (32) for determining the range in which the blood glucose concentration measured by the measuring sensor (26) is located;
- a control unit (32) for selectively illuminating the illuminating unit (20) in a first state when the comparator (32) determines that the concentration measured by the measuring sensor (26) is located in a first range, and in a second state distinct from the first state when the comparator (32) determines that the concentration measured by the measuring sensor (26) is located in a second range.
5. A portable blood analyser (10) according to any of the preceding claims characterized in that the illuminating unit (20) is able to illuminate the display unit (18) in at least three different states depending on the value of compound concentration measured by the measuring sensor (26).
6. A portable blood analyser (10) according to any of the preceding claims, characterized in that it comprises an acoustic unit (22) for emitting at least two different acoustic signals corresponding respectively to each different state of the illuminating unit (20).
7. A portable blood analyser (10) according to claim 6, characterized in that the or each acoustic signal is a voice message.
8. A portable blood analyser (10) characterized in that it comprises a blood holding stripe receptacle (27), the blood measuring sensor (26) being able to measure the concentration of the compound in the blood contained in a stripe (28) placed in the blood holding stripe receptacle (27).
9. A portable blood analyser (10) characterized in that the compound is chosen among glucose or cholesterol.
10. A portable blood analyser (10) according to any of the preceding claims, characterized in that it further comprises a start key (50) for activating the controller (16), the display unit (18) and the illuminating unit (20).
PCT/IB2006/003772 2006-12-27 2006-12-27 A portable blood analyzer for measuring the level of at least one compound contained in the blood of a patient WO2008078128A1 (en)

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PCT/IB2006/003772 WO2008078128A1 (en) 2006-12-27 2006-12-27 A portable blood analyzer for measuring the level of at least one compound contained in the blood of a patient

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PCT/IB2006/003772 WO2008078128A1 (en) 2006-12-27 2006-12-27 A portable blood analyzer for measuring the level of at least one compound contained in the blood of a patient

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Cited By (7)

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WO2010142447A1 (en) * 2009-06-11 2010-12-16 Roche Diagnostics Gmbh Portable handheld medical diagnostic devices with color-changing indicator
EP2383570A3 (en) * 2010-04-30 2013-05-01 Arkray, Inc. Measuring device, measuring method, and program
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WO2013102162A1 (en) * 2011-12-29 2013-07-04 Wellsense, Inc. Analyte sensor with extended range of detection
WO2014158845A1 (en) 2013-03-14 2014-10-02 Church & Dwight Co., Inc. Diagnostic test device with improved display
WO2016014393A1 (en) * 2014-07-23 2016-01-28 Bayer Healthcare Llc Light switching indicators by wavelength filtration
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WO2010142447A1 (en) * 2009-06-11 2010-12-16 Roche Diagnostics Gmbh Portable handheld medical diagnostic devices with color-changing indicator
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US9773399B2 (en) 2013-03-13 2017-09-26 Church & Dwight Co., Inc. Diagnostic test device with audible feedback
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