CA2245943A1 - Improved glucose monitor and test strip containers for use in same - Google PatentsImproved glucose monitor and test strip containers for use in same
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- CA2245943A1 CA2245943A1 CA 2245943 CA2245943A CA2245943A1 CA 2245943 A1 CA2245943 A1 CA 2245943A1 CA 2245943 CA2245943 CA 2245943 CA 2245943 A CA2245943 A CA 2245943A CA 2245943 A1 CA2245943 A1 CA 2245943A1
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-CA 0224~943 1998-08-11 WO 97/29847 ~C'r~US97~02166 IMPROVED GLUCOSE MONITOR AND TEST ST~IP
CONTAINERS FOR USE IN SAME
BA~KGROUND OF T~E INVENTION
This application relates to an improved type of glucose monitor which is automatically calibrated for the particular test strips being used, and to test strip containers for use in such a monitor.
~ lucose monitoring is a fact o~ everyday li~e ~or diabetic individuals, and the accuracy o~ such monitoring can literally mean the difference between life and death. To accommodate a normal li~e style to the need for ~requent monitoring o~ glucose levels, a number o~ glucose meters are now available which permit the individual to test the glucose level in a small amount o~
~lood. The success o~ these devices, however, depends on the ability of the user to obtain a correct reading.
Many o~ the meter designs currently available make use o~ a disposable test strip which in combination with the meter measures the amount o~ glucose in the blood sample electrochemically. Lot-to-lot variation during the manufacture o~ test strips requires that the user calibrate the system for each batch o~ strips. This is normally accomplished by inserting a calibration strip, provided with each package of test strips, into the meter. This process introduces the possibility o~
error as a result of ~ailure of the user to per~orm the calibration procedures in the correct manner or at the correct times. In particular, errors in calibration can occur if a user opens a new package o~ test strips and fails to perform the calibration step or if a user has several packages of test strips open and confuses the calibration strips between the packages.
It is an object of the present invention to provide a meter, and particularly a glucose meter, which obviates the need for user initiated calibration.
CA 0224~943 l998-08-ll W O 97/29847 PCT~US97/02166 It is a further object of the invention to provide a meter, and particularly a glucose meter, which ~ ~ reduces the likelihood of a test strip being used with the incorrect meter calibration.
5UMM~ F THE INV~TION
These and other objects of the invention are provided by a test meter of the type which receives a disposable test strip and a sample of bodily fluid from a patient and performs an electrochemical analysis of the amount of an analyte, for example glucose, in the sample that includes a receptacle for receiving a container in which disposable test strips are provided, and a mechan-ism ~or reading calibration values calibration values specific to the disposable test strips that are a~ixed to the container. For example, calibration values can be applied to the container in the form of a machine readable bar-code, a magnetic stripe, a memory chip or as a resonant wire loop. By automatically obt~i n; ng calibration values from the container in which the strips are provided, the chances of using the wrong calibration information are greatly reduced.
In addition to calibration values, the container may contain additional information readable by the meter which will enhance the safety of the individual using the device. For example, the container may include a machine readable expiration date, which would permit the meter to either give a warning or to refuse to process a test strip which was beyond its expiration date. In addition, the container may include information about the number of test strips in the container. Since any effort to process more strips than were originally supplied in the container would in all likelihood result in the use of the wrong calibration codes, a warning or re~usal to process the strip would be appropriate in this instance as well _ CA 0224~943 1998-08-11 WO 97~9847 PC~nUSg7J~2~66 BRT~ DES~RIPTION OF THE D~AWTNGS
Fig. 1 shows a cross ~ection of a glucose meter ~ ~ in accordance with the invention;
Fig. 2 shows a top view of a glucose meter in accordance with the invention;
Fig. 3 shows one embodiment of a receptacle for receiving a container of test strips in accordance with the invention;
Fiy. 4 shows one embodiment of a receptacle for receiving a container of test strips in accordance with the invention;
Fig. 5 shows the functional parts of a meter in accordance with the invention schematically;
Figs 6A - 6B illustrate the operation of several embodiments of the inventions; and Fig. 7 shows a container in accordance with the invention.
DETAILED DESCRIPTION OF THE INVENTION
Figs. 1 and 2 shows a meter in accordance with the invention. The meter has a top housing member 1 and a bottom housing member 2. Bottom housing member 2 has a receptacle 7 affixed thereto for receiving a container 10 of test strips. Bottom housing member 2 also has an opening for receiving batteries to power the meter which is sealed in use by battery cover 4. Top housing member 1 has openings formed therein for a liquid crystal or light emitting diode display 3, and for control buttons 5. In addition, top housing member 1 and bottom housing member 2 taken together form a slot 12 into which a test strip is inserted for measurement of glucose.
Fig. 3 shows a detailed view of one embodiment of a receptacle for a test strip container in accordance with the present invention. The receptacle 7 is open at the front end 31 to receive a test strip container and has a retractable catch 32 for holding the container in position in the receptacle. On one surface of the CA 0224~943 1998-08-ll W O 97/29847 PCTrUS97/02166 xeceptacle 7 is an opening 33 through which machine-readable character~, e.~. a bar code, printed on the ~ ~ container can be read. Although the receptacle 7 in Fig.
3 is shown as a regular shape, it may be desirable to make the container and the receptacle of corresponding asymmetrical shapes to ensure alignment of the machine-readable characters with the opening.
Fig. 4 shows a cross section of an alternative embodiment of the receptacle 7, In this embodiment, a line of electrical contacts 41 are arranged to engage with a corresponding set of contacts on the container to that information stored on a chip built into the container can be made. The contacts 41 are in turn connected to the meter for processing of the information.
Fig. S shows a functional parts of the glucose meter of the invention schematically for purposes of understanding the operation of the invention. As shown, coded information 50 recorded on a test strip container 10 disposed within receptacle 7 is functionally connected to means 51 for reading the information affixed to the container. The means for reading the information must, of course, be compatible with the manner in which the information 50 is recorded on the container. Thus, for example, in the case of information recorded in a bar-code ~ormat, the means 51 ~or reading the in~ormationaffixed to the container will be a bar-code reader. For a magnetic strip, the means 51 will be a magnetic stripe reader. In the case where the information on the container is recorded in a memory chip, for example a "TOUCH MEMORY" chip manufactured by Dallas Semiconductor or other semiconductor device capable of storing information for retrieval by a remote device, the means 51 for reading the information is a microprocessor which sends a ~uery to the chip and receives back a signal reflecting the stored contents of the chip. In the case where the information is stored as a resonating wire loop, the resonating frequency of which indicates the CA 0224~943 1998-08-11 W0 97/29847 PC'rJUS97~02166 information, the means 51 for reading the information is an rf generator and detector which scans across possible ~ ~ resonance frequencies and monitors for a resonant emission ~rom the wire loop.
The means 51 for reading the information is functionally connected to a microprocessor 52 for con-trolling the device. When the user depresses the start key 5, the microprocessor 52 queries the means 51 for reading the information ~rom the container and either evaluates the sample which has placed in the slot 12, evaluates the sample with a warning to the user, or refuses to evaluate the sample. If the sample is evalu-ated, with or without a warning, the microprocessor receives output from the electrodes 53 on the test strip, applies the calibration factors received from the means 51 for reading the in~ormation from the container, and causes the resulting glucose level to be displayed on display 3.
Figs. 6 A - E illustrate several variations of information 50 which can be recorded on a container in accordance with the present invention, and the ways in which the microprocessor 52 can make use of the recorded in~ormation. In Fig. 6A, the information 50 recorded on the container is simply the calibration values for the test strips in the container. In this case, the microprocessor 52 simply applies the calibration values to the raw electrode output and converts it to a digital value, to arrive at a calibrated glucose display.
In Fig. 6B, the information 50 recorded on the container includes both the calibration values and the number of test strips originally in the container.
Microprocessor 52 maintains a register 60 in which a counter X is stored. The counter X is set to zero whenever a new container is loaded into the receptacle 7, ~ 35 and is incremented each time a test strip is evaluated.
Each time the meter is used, the microprocessor 52 compares the value of X stored in register 60 to the , CA 0224~943 1998-08-11 W O 97/29847 PCTrUS97/02166 number of test strips originally in the container. If the X is less than or equal to the original number o~ test ~ ~ strips, the microprocessor operates in a normal m~nner and a calibrated glucose value is displayed. If X is greater than the original number o~ strips, the microprocessor generates an error signal. This error signal may cause the meter to provide a result together with a warning that the result is suspect, or may cause the microprocessor to refuse to display a result at all.
Fig. 6C shows an em~odiment in which the information 50 recorded on the cont~ ner includes cali-bration values and an expiration or manufacturing date.
In this case, the microprocessor 52 includes a clock 61 which is set initially by the user or by the factory and which is incremented automatically by the microprocessor to maintain the date accurately. The microprocessor 52 compares the expiration date recorded on the container to the clock, and acts in one o~ three ways depending on the results o~ this comparison. As shown, when the actual date is be~ore the expiration date by some pre-determined threshold amount, ~or example 10 days, the microprocessor ~2 simply generates a calibrated glucose display. When the actual date is closer to the expiration date than the predetermined threshold, and perhaps ~or several days after the expiration date, the microprocessor 52 generates a low level error signal which causes the meter to display a calibrated glucose reading along with a warning. Thereafter, the microprocessor generates a high level error signal which results in the meter re~using to provide a reading.
A variation on the embodiment shown in Fig. 6C
would use the clock to also monitor the time since the container was placed in the receptacle. In this case, as shown in Fig. 6D, the microprocessor would also include a storage register 64 in which the date on which a new container is placed in the receptacle is stored. In addition to checking the expiration date, the CA 0224~943 1998-08-11 WO 97/29847 PCT~TJS97~02~66 microprocessor 52 would also compare the current date to the date stored in register 62 If this difference were ~ ~ greater than a predetermined threshold level, the meter would generate a warning and/or refuse to operate. This embodiment is particularly useful where the shelf life of the test strips in the sealed container is longer than the shelf li~e after the cont~iner has been opened for first use. In addition, by generating a warning when a container of strips is lasting longer than expected, the 1~ meter could provide a rPmin~r that tests need to be performed on a regular basis.
Fig. 6E shows a further embodiment of the invention in which the information 5~ stored on the con-tainer includes both calibration values and the identifi-cation of the analyte for which the strip is intended.This embodiment is particularly useful where disposable test strips for several analytes, ~or example gluco~e and ketones can be evaluated in the same meter but require different processing of the raw data to obtain optimum results.
T~e various types of information and the resulting processing options depicted in the Figs 6A-6E
can be used in any combination. Thus, for example, a container in accordance with the invention might include calibration values, analyte ID and expiration date;
calibration values, number of strips and expiration date;
number of strips and expiration date; or any other combination of information types.
While the checks described above will greatly reduce the chances of using incorrect calibration values or out-of-date test strips, it may also be advantageous to provide the ability to deactivate the information stored on the container so that it cannot be used beyond a certain point. For example, deactivation of the container after a number of tests had been run equal to the number of strips into the container would eliminate the possi~ility that an individual might place additional CA 0224~943 1998-08-11 W O 97/29847 PCTrUS97102166 test strips which did not match the calibration values of the container.
~ ~ The mechanism of deactivation, like the mechanism for reading the information depends on the manner in which the in~ormation is stored. For example, in the case of a bar-code, the information might be rendered unreadable by exposing a photosensitive region to light which causes a color chanye for example to alter the bar code to an unreadable pattern. For an emitter loop, a ~usible link can be included which is fused by a pulse of an appropriate fre~uency, render the shorting the emitter loop and rendering it inoperative. In the case of a proy.d.ll..dble memory chip, deactivation might be accomplished by writing over a portion of the stored information, or by inducing a magnetic field near the chip of suf~icient magnitude to render the stored information meaningless, and there~ore unreadable. The generation of a magnetic ~ield will also render a magnetic stripe inoperative.
A ~urther aspect of the present invention is the containers which can be used in the meter according to the invention. As shown in Fig 7, such a container generally comprises a sealable body member 70 for receiving at least one glucose test strip; and machine-readable means 71 for storing information specific to disposable test strips provided in the container. As will be apparent ~rom the foregoiny discussion o~ the alternative reading means which can be included in a meter according to the invention, the machine readable means 71 can be a bar-code, a memory chip, or a resonant wire loop, or any other ~orm o~ machine readable storage which can be adapted ~or use in a small device o~ the type claimed.
7 The meter according to any of claims 1 to 5, wherein the information specific to the disposable test strip includes the number of test strips originally provided in the container, and the meter further comprises a data storage register for storing a value equal to the number of test strips used from the container and means for generating an error signal whenever the value stored in the data storage register exceed the number of test strips originally provided in the container.
8 The meter according to any of claims 1 to 5 or 7, wherein the information specific to the disposable test strip includes the expiration date of test strips provided in the container, and the meter further comprises a data storage register for storing the current date and means for generating an error signal whenever the value stored in the data storage register is later than the expiration date of the test strips provided in the container.
9. The meter according to claim 8, wherein the means for generating an error signal generates a low level error signal which causes the meter to display a calibrated result and a warning when the date stored in the data register is within some predetermined number of days before or after the expiration date, and a high level error signal which causes the meter to refuse to display a calibrated result when the date stored in the data register is more than the predetermined number of days after the expiration date.
10. The meter according to any of claims 1 to 5 or 7 to 9, further comprising means for rendering the information affixed to the container unreadable when a predetermined set of conditions is met.
11. The meter according to any of claims 1 to 5 or 7 to 10, wherein the analyte is glucose.
12 A container for disposable test strips for use in a test meter of the type which receives a disposable test strip and a sample of bodily fluid from a patient and performs an electrochemical analysis of the amount of an analyte in the sample in accordance with any of claims 1-5 or 7-11, comprising (a) a sealable body member for receiving at least one test strip; and (b) machine-readable means for storing information specific to disposable test strips provided in the container.
13. The container according to claim 12, wherein the machine-readable means is a bar-code.
14. The container according to claim 12, wherein the machine-readable means is a memory chip.
15. The container according to claim 12, wherein the machine-readable means is a resonant wire loop.
16. The container according to claim 12, wherein the machine-readable means is a magnetic stripe.
17. The container according to any of claim 12 to 16, further comprising means for rendering the machine-readable means unreadable in response to an externally applied signal.
18. The container according to any of claims 12 to 17, wherein the information specific to the test strips includes calibration values for the test strips.
19. The container according to any of claims 12 to 18, wherein the information specific to the test strips includes the number of test strips originally provided in the container.
20. The container according to any of claims 12 to 19, wherein the information specific to the test strips includes the expiration date of the test strips provided in the container.
Priority Applications (3)
|Application Number||Priority Date||Filing Date||Title|
|US08600449 US5989917A (en)||1996-02-13||1996-02-13||Glucose monitor and test strip containers for use in same|
|PCT/US1997/002166 WO1997029847A1 (en)||1996-02-13||1997-02-11||Improved glucose monitor and test strip containers for use in same|
|Publication Number||Publication Date|
|CA2245943A1 true true CA2245943A1 (en)||1997-08-21|
Family Applications (1)
|Application Number||Title||Priority Date||Filing Date|
|CA 2245943 Abandoned CA2245943A1 (en)||1996-02-13||1997-02-11||Improved glucose monitor and test strip containers for use in same|
Country Status (1)
|CA (1)||CA2245943A1 (en)|
Cited By (1)
|Publication number||Priority date||Publication date||Assignee||Title|
|EP1950562A3 (en) *||2002-04-02||2009-06-17||Lifescan Scotland Limited||Integrated sample testing meter|
Cited By (1)
|Publication number||Priority date||Publication date||Assignee||Title|
|EP1950562A3 (en) *||2002-04-02||2009-06-17||Lifescan Scotland Limited||Integrated sample testing meter|
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