WO2006076668A1 - Dispositif et procede d'affichage et d'impression d'une concentration d'analyte dans un echantillon de fluide - Google Patents

Dispositif et procede d'affichage et d'impression d'une concentration d'analyte dans un echantillon de fluide Download PDF

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Publication number
WO2006076668A1
WO2006076668A1 PCT/US2006/001406 US2006001406W WO2006076668A1 WO 2006076668 A1 WO2006076668 A1 WO 2006076668A1 US 2006001406 W US2006001406 W US 2006001406W WO 2006076668 A1 WO2006076668 A1 WO 2006076668A1
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WO
WIPO (PCT)
Prior art keywords
test device
sample
analyte
concentration
removable memory
Prior art date
Application number
PCT/US2006/001406
Other languages
English (en)
Inventor
Robert D. Schell
Original Assignee
Bayer Healthcare Llc
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 Bayer Healthcare Llc filed Critical Bayer Healthcare Llc
Publication of WO2006076668A1 publication Critical patent/WO2006076668A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546—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 analytes not otherwise provided for, e.g. ions, cytochromes
    • 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
    • A61B5/1486—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 enzyme electrodes, e.g. with immobilised oxidase
    • 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

Definitions

  • the present invention relates generally to liquid-sample monitoring devices and, more particularly, to a liquid sample monitoring device with a removable memory adapted to be used to provide a graphical representation of the analyte concentration in a liquid sample to a computer or a printer.
  • self- testing systems are used for determining the presence or concentration of other analytes in body fluids, such as, for example, cholesterol, alcohol, and hemoglobin in blood, interstitial fluid, or chemical substances in saliva.
  • FIG. 1 A prior art blood glucose test device 10 is illustrated in FIG. 1.
  • the portable nature of these devices 10 enables users to conveniently test their blood glucose levels wherever the users may be.
  • the test device 10 receives a test sensor 12 for harvesting the blood for analysis.
  • the test sensor 12, one of which is required for each test contains a reaction area including a reagent for producing a measurable reaction with the glucose indicative of the blood glucose concentration level.
  • the test sensor harvests the blood, either prior to or subsequent to insertion into the testing device, for reaction with the reagent stored within.
  • the prior art device 10 contains a switch 14a to activate the device 10 and a display 16 to display the results of the blood glucose analysis. Alternatively, the device 10 is automatically activated upon receipt of the test sensor 12.
  • a drop of blood is obtained from, for example, a lanced fingertip.
  • the blood is harvested using the test sensor 12.
  • the test sensor 12, which is inserted into the test device 10 is brought into contact with the blood drop.
  • the test sensor 12 moves the blood to the inside thereof via, for example, capillary action.
  • the blood sample is harvested prior to inserting the test sensor 12 into the test device 10.
  • the blood sample now within the test sensor 12 mixes with the reagent causing a reaction between the reagent and the glucose in the blood sample.
  • test device 10 measures the reaction to determine the glucose concentration in the blood sample.
  • the results of the test are displayed on the display 16 of the test device 10. Once the results are displayed, the test sensor 12 is discarded. An additional test would require a new test sensor 12.
  • test sensors such as, electrochemical or optical (e.g., colorimetric) test sensors to measure blood glucose concentration levels.
  • Some prior art devices have allowed the user to transfer results from the test device to a computer or a printer serially through a cable or through an infrared ("IR") port.
  • IR infrared
  • these devices required the user to obtain software specifically designed to process the data received from the test device into a format that the computer or printer may recognize, or a special printer containing specific software to process data received from the test device was required.
  • An example of such a program is ASCENCIA® WINGLUCOF ACTS® diabetes management software. Therefore, a need exists for a user-friendly device that allows the user to transfer results from the test device to a computer or printer without the need for special processing equipment.
  • a test device for determining an analyte concentration in a liquid sample comprises a measuring unit, a processor, a removable memory device, and a user display.
  • the measuring device is adapted to measure the reaction of a reagent and the analyte and generates a signal indicative of the measured reaction.
  • the processor is electrically coupled to the measuring unit.
  • the processor is adapted to determine the analyte concentration in the sample in response to receiving the signal indicative of the measured reaction from the measuring unit.
  • the removable memory device is electronically coupled to the processor and stores the analyte concentration.
  • the removable memory device includes storage of a current sample concentration and at least one prior sample concentration.
  • the user display is electronically coupled to the processor. The user display automatically displays the concentration of the current sample.
  • a hard copy of a plurality of sample test results stored on a test device that has a removable memory device in which a concentration of at least one past sample is stored is obtained.
  • the test device is adapted to receive a test sensor for collecting the sample.
  • the test sensor contains a reagent adapted to produce a reaction indicative of an analyte concentration in the sample.
  • the process comprises measuring the reaction between an analyte in a current sample and the reagent contained in the test sensor. The concentration of the analyte in the current sample is determined. The concentration of the analyte in the current sample is stored in the removable memory device.
  • the removable memory device is removed from the test device.
  • the removable memory device is inserted into a memory device reader.
  • the stored results in the removable memory are read with the memory device reader.
  • the stored results are printed with a printer.
  • FIG. 1 is a front view of a prior art blood glucose test device.
  • FIG. 2 is a front view of a test device for determining an analyte concentration according to one embodiment of the present invention.
  • FIG. 3 is a functional block diagram of the test device of FIG. 2.
  • FIG. 4 is a functional block diagram of the test device of FIG. 2 according to an alternative embodiment.
  • FIG. 5 is a view of one embodiment of a display to be used on the test device of
  • FIG. 6 is a view of hard copy of the test results generated on the test device of
  • a test device 20 for determining a user's analyte concentration level in a fluid sample is shown according to one embodiment of the present invention. While the following discussion describes determining the glucose concentration in blood, it is understood that the present invention may be employed in determining the concentration of other analytes in other types of samples. Analytes that may be measured using the present invention include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin A 1C , fructose, lactate, or bilirubin.
  • lipid profiles e.g., cholesterol, triglycerides, LDL and HDL
  • microalbumin e.g., microalbumin
  • hemoglobin A 1C e.g., fructose, lactate, or bilirubin.
  • the present invention is not limited, however, to these specific analytes and it is contemplated that other analyte concentrations may be determined.
  • the analytes may be in, for example, a whole blood sample, a blood serum sample, a blood plasma sample, or other body fluids like ISF (interstitial fluid) and urine.
  • the test device 20 includes a housing 22, a test sensor 24, a power button 26a, a plurality of optional control buttons 26b-26e, a display panel 28, and an optional indicating mechanism 30.
  • the power button 26a is used to turn the test device 20 on and off. Alternatively, the test device 20 may automatically activate upon receipt of a test sensor 24. Alternatively, an initial activation (e.g., depression) of one of the control buttons 26b-26e activates the test device 20.
  • the display panel 28 displays the test results.
  • the optional indicating mechanism 30 e.g., an LED
  • an alarm condition such as an abnormal reading, a glucose reading that is too high or too low, or another problem with the test device 20. In an alternative embodiment, there is no indicating mechanism 30 and the display panel 28 may be used to alert the user to an alarm condition.
  • the test device 20 includes a measuring unit 32 that receives a fluid collection apparatus or test sensor 34.
  • the measuring unit comprises a spectrograph, a photometric measuring unit, or other measuring unit.
  • the test sensor 34 includes a reagent 36 that reacts with a blood sample, creating a measurable reaction indicative of the concentration of glucose in the blood sample.
  • the type of reagent implemented in the test device 20 depends on the type of measuring used. For example, in colorimetric testing, the reagent reacts with the glucose in a blood sample causing a colorimetric reaction indicative of the glucose concentration level.
  • a photometric measuring unit or other optical device reads the degree of color change. Colorimetric testing is described in detail in commonly-owned U.S. Patent Nos. 6,181,417 (entitled “Photometric Readhead With Light Shaping Plate”), 5,518,689 (entitled “Diffuse Light Reflectance Readhead”), and 5,611,999 (entitled “Diffuse Light Reflectance Readhead”). It is contemplated that other colorimetric or optical devices may be used. [0020] Referring next to FIG. 4, a test device 20 having an electrochemical measuring unit 42 is illustrated according to an alternate embodiment of the present invention.
  • the reagent is designed to react with glucose in the blood to create an oxidation current at electrodes 44 that is directly proportional to the glucose concentration in the user's blood.
  • the current is measured by the electrochemical measuring unit 42, that is electrically coupled to the electrodes 44.
  • An example of an electrochemical testing system is described in detail by commonly-owned U.S. Patent No. 5,723,284 (entitled “Control Solution And Method For Testing The Performance Of An Analyte In Blood”). It is contemplated that other electrochemical testing systems may be used.
  • the test device 20 includes a processor 38 that is electrically coupled to the measuring unit 32 (FIG. 3) or the electrochemical measuring unit 42 (FIG. 4) and the power button 26a.
  • the processor 38 calculates the blood glucose level and outputs the result to the display 28.
  • the processor 38 is also connected to a removable memory 40 for storing information regarding glucose readings, such as the blood glucose level, the date of the measurement, and the time of the measurement.
  • the processor 38 can also produce summaries, graphical or tabular text, of the stored data in graphical file formats and store the summaries in the removable memory device 40.
  • the processor 38 also has a permanent memory to store information regarding test results.
  • a test device may comprise both a permanent memory and a removable memory.
  • the removable memory 40 allows a user to easily transfer the information stored in the memory 40 to a computer or a printer.
  • removable memory 40 formats that may be used include, but are not limited to, COMPACT FLASH®, SMARTMEDIATM, MEMORY STICK®, XD-PICTURE CARDTM, MULTIMEDIACARDS®, and SECURE DIGITALTM ("SDTM"). Due to the fact that SDTM is small in size and may be used with a serial peripheral interface, SDTM is well suited to be used as the removable memory 40 of the test device 20.
  • the processor 38 of the test device 20 communicates the information regarding the blood glucose readings to the removable memory 40 in file formats that are widely recognized by computers and printers, such as ASCII for individual test results or a table of test results, and JPEG or TIFF for graphical results. Graphical results are typically used when a user wishes to chart test results over a period of time to observe trends in blood glucose levels or determine modal days.
  • file formats that are widely recognized by computers and printers, such as ASCII for individual test results or a table of test results, and JPEG or TIFF for graphical results.
  • Graphical results are typically used when a user wishes to chart test results over a period of time to observe trends in blood glucose levels or determine modal days.
  • the use of widely recognized file formats on the removable memory card 40 allows the user to easily transfer the data contained on the memory card 40 to a printer or a computer. Many printers now feature memory card readers and support JPEG and TIFF file formats so that photographs taken with digital cameras may be printed without the need for a computer.
  • a printer is the PHOTOSMART 7960® printer manufactured by HE WLETT-P ACKARD®.
  • a user could use a photo kiosk at a camera center or retail outlet to eliminate the need to have their own printer. Allowing the user to print results directly from the removable memory 40 simplifies the process a user must follow to obtain a hardcopy of the results of blood glucose analysis. The user no longer has to use cables to transfer data out of the test device and into a printer or computer, which can be a frustrating experience for the user.
  • the processor 38 of the device 20 store the results of the testing onto the removable memory 40 in a file format that is supported by many software programs and printers, the user does not have to manipulate the data to obtain useable information. Using common file formats for the data stored in the removable memory 40 also eliminates the need for costly software to process the data produced by the testing device 20.
  • the hardcopy makes it easier for the user to share testing results with healthcare providers, increasing the amount of information the healthcare provider has to assist the user in blood glucose management. Providing the healthcare provider with additional information allows the user to obtain better medical advice, leading to greater control of the user's blood glucose level.
  • the display 28 includes a bar-graph display 50 made up of a plurality of boxes 52.
  • the vertical axis of the bar-graph display represents the glucose concentration in the sample, while the horizontal axis represents the time that the sample was obtained, hi this embodiment, the bar-graph includes six boxes 52 arranged vertically to represent six different ranges of glucose readings. For example, each box may represent a range of approximately 75 mg/dL.
  • the bar-graph also includes two horizontal lines 54a, 54b.
  • the two lines 54a, 54b are shown to illustrate to the user a "normal” or average glucose concentration.
  • the boxes 56 above the line 54a indicate “high” glucose concentrations, while the boxes 56 below the line 54b indicate “low” glucose readings.
  • a numerical display 56 indicates the date, time, and exact concentration of a most current sample 58.
  • the user may scroll from the most recent sample through past samples.
  • the data for the past samples are stored in the removable memory 40 (FIG. 2) of the test device 20.
  • the display screen will highlight the various samples, according to one embodiment. It is also contemplated that the numerical display 56 will display the exact concentration level and the date and time when the highlighted sample was measured.
  • the user may obtain a hardcopy of the bar-graph display 50 by removing the removable memory 40 and placing the removable memory 40 directly in a printer or a computer, hi some embodiments, the hardcopy of the bar-graph display 50 will include a table of the exact concentration of all of the samples on the bar-graph display 50, as well as the date and time when the sample was measured. In this manner, all of the information typically stored in the removable memory 40 is recorded on the hardcopy of the bar-graph display. It is also contemplated that in some embodiments the display 28 will display a bar-graph that does not include discreet boxes 52, but rather shows continuous bars that represent the glucose reading.
  • data stored to a removable memory will allow a hardcopy of the data to be created that contains a higher resolution and additional data not shown on a display of the device.
  • the display 28 of the test device 20 of the present invention may only be an alphanumeric display. By having the display 28 only be an alphanumeric display the cost of producing the test device 20 may be greatly reduced.
  • the processor 38 is able to store and process the test results to the removable memory 40 in a form that allows the user to simply transfer the data stored in the removable memory 40 to a computer or a printer.
  • the processor 38 may alternatively store a summary of all test results to allow a user to obtain a summary of the test results, hi this manner the user may still obtain a hardcopy of a graphical representation of all test results stored on the removable memory 40, but the device 20 does not need to have a costly display capable of displaying graphical results.
  • the graph may be a line graph 62, such as the one shown in FIG. 6.
  • FIG. 6 illustrates a hardcopy 60 with the line graph 62 and the table of results 66. Each glucose concentration sample is indicated by a point 64 on the graph 62.
  • the user may obtain the hardcopy 60 of the results by removing the removable memory 40 and placing the removable memory 40 directly in a printer or a computer. In this manner, all of the information typically stored in the removable memory 40 is recorded on the hardcopy of the line graph.
  • the hardcopy may only contain a line graph to provide the test results.
  • the hardcopy may only contain the table of results to provide the test results.
  • a test device for determining an analyte concentration in a liquid sample comprising: a measuring unit adapted to measure the reaction of a reagent and the analyte and to generate a signal indicative of the measured reaction; a processor electronically coupled to the measuring unit, the processor being adapted to determine the analyte concentration in the sample in response to receiving the signal indicative of the measured reaction from the measuring unit; a removable memoiy device electronically coupled to the processor for storing the analyte concentrations, the removable memory device including storage of a current sample concentration and at least one prior sample concentration; and a user display electronically coupled to the processor for displaying the analyte concentration of the current sample.
  • test device of Alternative Embodiment A wherein the removable memory device stores a summary of the analyte concentration data from a plurality of samples as a graph in a graphical file format.
  • test device of Alternative Embodiment A wherein the removable memory device stores a summary of the analyte concentration data from a plurality of samples as a text table in a graphical file format.
  • a method for obtaining a hard copy of a plurality of sample results stored on a test device the test device having a removable memory device in which an analyte concentration of at least one past sample is stored, the test device being adapted to receive a test sensor for collecting the sample, the test sensor containing a reagent adapted to produce a reaction indicative of the analyte concentration in the sample, the method comprising the acts of: measuring the reaction between the analyte in a current sample and the reagent contained in the test sensor; determining the concentration of the analyte in the current sample; storing the concentration of the analyte in the current sample in the removable memory device; removing the removable memory device from the test device; inserting the removable memory device into a memory device reader; and reading the stored results in the removable memory device with the memory device reader.

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Abstract

L'invention porte sur un dispositif test permettant de déterminer la concentration d'analyte dans un échantillon de fluide. Ce dispositif test comprend une unité de mesure, un processeur, un dispositif de mémoire amovible, et un écran d'utilisateur. Cette unité de mesure est conçue pour mesurer la réaction d'un réactif et de l'analyte afin de générer un signal indiquant la réaction mesurée. Le processeur est électroniquement relié à l'unité de mesure et est conçu pour déterminer la concentration d'analyte dans l'échantillon en réponse au signal issu de l'unité de mesure. Le dispositif à mémoire amovible est électroniquement relié au processeur afin de stocker la concentration d'analyte d'une concentration d'échantillon actuelle et d'au moins une concentration d'échantillon antérieure. L'affichage d'utilisateur est électroniquement relié au processeur et affiche automatiquement la concentration de l'échantillon actuel.
PCT/US2006/001406 2005-01-14 2006-01-13 Dispositif et procede d'affichage et d'impression d'une concentration d'analyte dans un echantillon de fluide WO2006076668A1 (fr)

Applications Claiming Priority (2)

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US64389205P 2005-01-14 2005-01-14
US60/643,892 2005-01-14

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WO2006076668A1 true WO2006076668A1 (fr) 2006-07-20

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Cited By (1)

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