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Patent 2245943 Summary

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Claims and Abstract availability

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(12) Patent Application: (11) CA 2245943
(54) English Title: IMPROVED GLUCOSE MONITOR AND TEST STRIP CONTAINERS FOR USE IN SAME
(54) French Title: DISPOSITIF PERFECTIONNE DE CONTROLE DU GLUCOSE ET CONTENANTS POUR BANDES DE TEST UTILISABLES DANS CE DISPOSITIF
Status: Dead
Bibliographic Data
(51) International Patent Classification (IPC):
  • G01N 33/66 (2006.01)
  • B01L 99/00 (2010.01)
  • C12M 1/34 (2006.01)
  • C12M 1/40 (2006.01)
  • G01N 33/50 (2006.01)
  • G01N 37/00 (2006.01)
(72) Inventors :
  • MCALEER, JEROME F. (United Kingdom)
  • MOERMAN, PIET H. C. (Belgium)
  • SIU, TA (United States of America)
(73) Owners :
  • DIABETES DIAGNOSTICS, INC. (United States of America)
(71) Applicants :
  • SELFCARE, INC. (United States of America)
(74) Agent: CASSAN MACLEAN
(74) Associate agent:
(45) Issued:
(86) PCT Filing Date: 1997-02-11
(87) Open to Public Inspection: 1997-08-21
Examination requested: 2002-02-01
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US1997/002166
(87) International Publication Number: WO1997/029847
(85) National Entry: 1998-08-11

(30) Application Priority Data:
Application No. Country/Territory Date
08/600,449 United States of America 1996-02-13

Abstracts

English Abstract




e 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 such as glucose in the sample includes a receptacle (7)
for receiving a container (10) in which disposable test strips are provided,
and a mechanism for reading information about the disposable test strips that
is affixed 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 obtaining calibration
values from the container in which the strips are provided, the chances of
using the wrong calibration information are greatly reduced. The container may
also contain information readable by the meter including the expiration date,
and the number of test strips in the container.


French Abstract

Cette invention concerne un dispositif de mesure dans lequel on place une bande de test à jeter et un échantillon de fluide corporel provenant d'un patient et qui exécute une analyse électrochimique de façon à mesurer la concentration d'un analyte, tel que le glucose, présent dans l'échantillon. Ce dispositif de mesure comporte un réceptacle (7) conçu pour loger le contenant (10) dans lequel sont placées les bandes de test à jeter, et un mécanisme qui permet de lire des informations relatives aux bandes de test à jeter et qui est fixé au contenant. Des valeurs d'étalonnage, par exemple, peuvent être appliquées au contenant sous la forme d'un code à barres exploitable par ordinateur, d'une bande magnétique, d'une puce à mémoire ou d'une boucle métallique résonnante. L'obtention automatique des valeurs d'étalonnage issues du contenant dans lequel sont placées les bandes, permet de réduire considérablement les possibilités d'utilisation d'informations d'étalonnage erronées. Ledit contenant peut également comporter des informations exploitables par ledit dispositif de mesure telles que la date d'expiration et le nombre de bandes de test présentes dans le contenant.

Claims

Note: Claims are shown in the official language in which they were submitted.



- 9 -
Claims

1. A test meter of the type which receives a
disposable test strip and a sample of bodily fluid from a
patient into a slot connecting with the interior of the
meter and performs an electrochemical analysis of the
amount of an analyte in the sample, said meter including
means for calibrating the meter and means for displaying
a calibrated value for the amount of analyte,
characterized in that the meter comprises
(a) a receptacle for receiving a container in
which a plurality of disposable test strips are provided,
said container having affixed thereto information
specific to the disposable test strips provided in the
container in a form readable by the test meter, said
receptacle being separate from the slot connecting to the
interior of the meter; and
(b) means for reading the information affixed
to the container.

2. The test meter according to claim 1,
wherein the means for reading the information comprises a
bar-code reader.

3. The test meter according to claim 1,
wherein the means for reading the information comprises a
radio frequency emitter and receiver effective to
evaluate a resonant wire loop used to store information
specific to the test strips in the container.

4. The test meter according to claim 1,
wherein the means for reading the information comprises a
microprocessor for retrieving information from a memory
chip used to store information specific to the test
strips in the container.


- 10 -
5. The meter according to any of claims 1 to
4, wherein the information specific to the disposable
test strip includes calibration values for the disposable
test strips, and wherein the meter further comprises
means for applying the calibration values to a raw data
value to produce a calibrated value for the amount of
analyte.

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



- 11 -

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.


- 12 -
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.

Description

Note: Descriptions are shown in the official language in which they were submitted.


-
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

DESCRIPTION
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
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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
-- 5
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.

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date Unavailable
(86) PCT Filing Date 1997-02-11
(87) PCT Publication Date 1997-08-21
(85) National Entry 1998-08-11
Examination Requested 2002-02-01
Dead Application 2008-02-11

Abandonment History

Abandonment Date Reason Reinstatement Date
2007-02-12 FAILURE TO PAY APPLICATION MAINTENANCE FEE
2007-04-30 R30(2) - Failure to Respond

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Application Fee $300.00 1998-08-11
Maintenance Fee - Application - New Act 2 1999-02-11 $100.00 1999-01-13
Registration of a document - section 124 $100.00 1999-08-11
Maintenance Fee - Application - New Act 3 2000-02-11 $100.00 2000-02-09
Registration of a document - section 124 $100.00 2000-11-14
Maintenance Fee - Application - New Act 4 2001-02-12 $100.00 2001-01-31
Maintenance Fee - Application - New Act 5 2002-02-11 $150.00 2002-01-18
Request for Examination $400.00 2002-02-01
Registration of a document - section 124 $100.00 2002-08-27
Registration of a document - section 124 $100.00 2002-08-27
Maintenance Fee - Application - New Act 6 2003-02-11 $150.00 2003-01-22
Maintenance Fee - Application - New Act 7 2004-02-11 $200.00 2004-01-30
Maintenance Fee - Application - New Act 8 2005-02-11 $200.00 2005-01-31
Maintenance Fee - Application - New Act 9 2006-02-13 $200.00 2006-01-25
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
DIABETES DIAGNOSTICS, INC.
Past Owners on Record
INVERNESS MEDICAL TECHNOLOGY, INC.
MCALEER, JEROME F.
MOERMAN, PIET H. C.
SELFCARE, INC.
SIU, TA
SUNRISE ACQUISITION CORP.
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Representative Drawing 1998-11-16 1 7
Claims 2002-12-18 9 356
Abstract 1998-08-11 1 63
Description 1998-08-11 8 421
Claims 1998-08-11 4 137
Drawings 1998-08-11 6 97
Cover Page 1998-11-16 2 69
Correspondence 1998-10-20 1 31
Prosecution-Amendment 1998-08-11 1 18
PCT 1998-08-11 14 496
Assignment 1998-08-11 3 107
Assignment 1999-08-11 6 338
Assignment 1999-08-23 1 31
Assignment 2000-11-14 4 127
Prosecution-Amendment 2002-02-01 1 41
Assignment 2002-08-27 7 206
Prosecution-Amendment 2002-12-18 10 390
Correspondence 2003-02-10 9 23
Fees 2002-01-18 1 32
Fees 2001-01-31 1 34
Fees 2000-02-09 1 26
Prosecution-Amendment 2006-10-31 2 53