Note: Descriptions are shown in the official language in which they were submitted.
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
CONTAINER WITH RFID DEVICE FOR STORING TEST SENSORS
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
The present invention relates, in general, to containers for sensors having a
mechanism
for storing calibration information and, more particularly, to test sensor
containers
comprising a radio frequency identification device, and a method for entering
calibration information into an analytical device.
[0002] 2. Background to the Invention
Devices and methods for measuring analytes in fluids, as well as test sensors
such as
strips for use in such devices and methods, are well known. Typically, the
test strips are
stored in a disposable container that is separate from the device, such as a
handheld
photometric or electrochemical meter, that measures the analyte of interest. A
test strip
is removed from the container, a sample of fluid is dispensed onto the strip,
and the
strip is inserted into the apparatus for analysis of the desired component.
After analysis
is completed, the test strip is extracted from the meter and the strip
disposed.
[0003] Systems comprising such meters and strips are particularly useful in
the management
and monitoring of chronic conditions such as diabetes, whereby the analyte to
be
determined is glucose and the fluid is whole blood. Such meters have been
commercially available for several years, examples of which are the OneTouch*
Ultra*
test strip and meters (*produced by and a trademark of LifeScan Inc.,
Milpitas,
California). The portability of such systems provides advantages to the user,
however
other disadvantages remain. One such disadvantage is that the user must
generally enter
information into the meter to account for the variability in performance of
the test
strips. This variability in test strip performance is generally due to
variability in the
manufacturing conditions of the strips that are generally produced in batches.
The
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
information that the user enters into the meter is generally calibration
information
comprising, for example, a set of calibration parameters and/or a calibration
number
and/or other information that is used to adjust internal calculation settings
in the meter.
These latter settings are then used to adjust the measured value of analyte
present in the
sample on the strip. The calibration information is usually provided with the
strip
container and is typically printed on a label that is affixed to the outside
of the
container. However, the risk remains that an incoiTect measurement is made,
either
because the user enters the calibration information incorrectly or because the
user has
forgotten to update the calibration information when appropriate. Typically,
calibration
information varies from batch to batch and a user should normally check and
update the
calibration information in the meter each time sensors from a different batch
are used,
for example, when a new container of sensors is opened.
[0004] There remains therefore a need for a means to provide calibration
information to a
meter that reduces the risk of incorrect entry of that information into the
meter.
[0005] In this document, where reference is made to strips or test strips, it
is to be understood
that sensors or test sensors of any size or shape could be used as would be
understood
by someone skilled in the art.
[0006] US patent number 5,989,917 (by the present applicant) describes a
glucose monitor and
test strip containers for use in the same.
SUMMARY OF THE INVENTION
[0007] In one aspect the invention relates to a container for storing test
strips comprising a
body, a base, an enclosing mechanism and a radio frequency identification
device and
to containers for storing test strips comprising a body, a base, an enclosing
mechanism
and a radio frequency identification device wherein the radio frequency
identification
device has a microchip that has information storage capability for information
relating
2
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
to the calibration of an analyte measurement apparatus for use with test
strips stored in
the container.
[0008] In a further aspect the invention further also relates to methods of
producing containers
for storing test strips comprising a body, a base, an enclosing mechanism and
a radio
frequency identification device
[0009] Another aspect of the present invention relates to a method for
reducing the risk that
calibration information is entered incorrectly into a test meter.
[0010] One example embodiment relates to a container for storing test sensors
comprising an
outermost surface and an innermost surface and a radio frequency
identification device
located between the outermost surface and the innermost surface.
[0011] Another example embodiment relates to a container comprising at least
one layer of
material and the radio frequency identification device is embedded therein.
Optionally
at least one layer of the container comprises a sorbent. Optionally, the
sorbent
comprises bentonite or a hydrophillically modified silica.
[0012] Another example embodiment relates to a container comprising a
polyolefin
composition. Optionally, the polyolefin composition comprises polypropylene.
[0013] Another example embodiment relates to a container comprising a cavity
wherein a
radio frequency identification device is located within the cavity.
Optionally, the radio
frequency identification device is located on an innermost surface of the
container.
[0014] Another example embodiment relates to a container wherein the container
comprises
two or more layers and a radio frequency 'identification device is located
within an
outer layer. Optionally, the radio frequency identification device is embedded
in the
outer layer.
3
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
[0015] Another example embodiment relates to a container comprising two or
more layers and
a radio frequency identification device is located within an inner layer.
Optionally, the
radio frequency identification device is embedded in the inner layer.
[0016] Another example embodiment relates to a container comprises two or more
layers and a
radio frequency identification device is located between an inner layer and an
outer
layer.
[0017] Another example embodiment relates to a container wherein container
comprises two
or more layers and the radio frequency identification device is located within
an
enclosing mechanism.
[0018] Another example embodiment relates to a container according to any one
of the
preceding claims further comprising 4 label having a radio frequency
identification
device. Optionally the label comprises an adhesive suitable for affixing.
Optionally the
radio frequency identification device is present on the outermost surface of
the label
and/or is located in or adjacent to the label adhesive.
[0019] Another example embodiment relates to a container wherein the radio
frequency
identification device has information storage capability for information
relating to the
calibration of an analyte measurement apparatus for use with test strips
stored in the
container.
[0020] Another aspect of the present invention is a method for entering
calibration information
into a test meter, wherein a container comprising an RFID device having
calibration
information that accounts for the performance variability of test strips
present in the
container, and a meter provided with a radio transmitter and receiver and a
means for
converting received radio signals into calibration parameters for the meter,
are brought
into close proximity, generally within a distance of about 0 meters (m) to
about 100 m,
optionally within 0 m and 0.2 m, whereupon a means of transferring the
calibration
4
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
information is actuated to transfer the calibration information as a radio or
microwave
signal from the microchip to the receiver.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The novel features of the invention are set forth with particularity in
the appended
claims. A better understanding of the features and advantages of the present
invention
will be obtained by reference to the following detailed description that sets
forth
illustrative embodiments, in which the principles of the invention are
utilized, by way
of example only, and the accompanying drawings in which:
[0022] Fig. I is an elevational cross-sectional schematic view of one
embodiment of a
container in accordance with the present invention showing an RFID device
affixed to
an innermost surface of the body of the container.
[0023] Fig. 2 is an overhead plan schematic view of one embodiment of a
container in
accordance with the present invention.
[0024] Fig. 3 is an elevational cross-sectional schematic view of one
embodiment of a
container in accordance with the present invention showing an RFID device
affixed to
an innermost surface of the base of the container.
[0025] Fig. 4 is an elevational cross-sectional schematic view of one
embodiment of a
container in accordance with the present invention showing an RFID device
affixed to
an innermost surface of an enclosing mechanism of the container.
[0026] Fig. 5 is an elevational cross-sectional schematic view of one
embodiment of a
container in accordance with the present invention showing an RFID device
comprising
a supporting substrate affixed to an innermost surface of the body of the
container.
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
[0027] Fig. 6 is an elevational cross-sectional schematic view of one
embodiment through a
container in accordance with the present invention showing an RFID device
coinprising
a supporting substrate affixed to an innermost surface of the base of the
container.
[0028] Fig. 7 is an elevational cross-sectional schematic view of one
embodiment of a
container in accordance with the present invention showing an RFID device
comprising
a supporting substrate affixed to an innermost surface of an enclosing
mechanism of the
container.
[0029] Fig. 8 is an elevational cross-sectional schematic view of one
embodiment of a
container in accordance with the present invention showing an RFID device
located in
the inner layer of the body of the container.
[0030] Fig. 9 is an elevational cross-sectional schematic view of one
embodiment through a
container in accordance with the present invention showing an RFID device
present in
the inner layer of the base of the container.
[0031] Fig. 10 is an elevational cross-sectional schematic view of one
embodiment through a
container in accordance with the present invention showing an RFID device
present in
the inner layer of the enclosing mechanism of the container.
100321 Fig. 11 is an elevational cross-sectional schematic view of one
embodiment through a
container in accordance with the present invention showing an RFID device
present in
the outer layer of the body of the container.
[0033] Fig. 12 is an elevational cross-sectional schematic view of one
embodiment through a
container in accordance with the present invention showing an RFID device
located in
the outer layer of the base of the container.
6
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
[0034] Fig. 13 is an elevational cross-sectional schematic view of one
embodiment through a
container in accordance with the present invention showing an RFID device
located in
the outer layer of the enclosing mechanism of the container.
[0035] Fig. 14 is an elevational cross-sectional schematic view of one
embodiment of a
container in accordance with the present invention showing an RFID device
located
between the inner layer and outer layer of the body of the container.
[0036] Fig. 15 is an elevational cross-sectional schematic view of one
embodiment of a
container in accordance with the present invention showing an RFID device
located
between the inner layer and outer layer of the base of the container.
[00371 Fig. 16 is an elevational cross-sectional schematic view of one
embodiment through a
container in accordance with the present invention showing an RFID device
located
between the inner layer and outer layer of the enclosing mechanism of the
container.
[0038] Fig. 17 is an elevational cross-sectional schematic view of one
embodiment through a
container in accordance with the present invention showing an RFID device
located on
the outer surface of the outer layer of the body of the container.
[0039] Fig. 18 is an elevational cross-sectional schematic view of one
embodiment of a
container in accordance with the present invention showing an RFID device
located on
the outermost surface of the outer layer of the base of the container.
[00401 Fig. 19 is an elevational cross-sectional schematic view of one
embodiment of a
container in accordance with the present invention showing an RFID device
located on
the outer surface of the outer layer of the enclosing mechanism of the
container.
[0041] Fig. 20 is an elevational cross-sectional schematic view of one
embodiment through a
container comprising a label in accordance with the present invention showing
an RFID
device located on the outer surface of the label.
7
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
[0042] Fig. 21 is an elevational cross-sectional schematic view of one
embodiment through a
container comprising a label in accordance with the present invention showing
an RFID
device located in the adhesive layer of the label.
[0043] Fig 22 is an elevational cross-sectional schematic view of one
embodiment of a
container in accordance with the present invention showing representative
slots and
recesses into which an RFID device (not shown) can be located.
DETAILED DESCRIPTION OF THE DRAWINGS
[0044] Fig. 1 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention. The container (2)
comprises a
cavity (4), a body (6), a base (8) and an enclosing mechanism (8). In the
illustrated
embodiment the body (6), base (8) and enclosing mechanism (8) of the container
(2)
each comprise an outer layer (12) and an iiiner layer (14) and each outer
layer (12) is
connected to an inner layer (14) by a first tie-layer (16). Each outer layer
(12) has an
outermost surface (18) and each inner layer (14) has an innermost surface
(20). A radio
frequency identification (RFID) device (22) is affixed to the innermost
surface (20) of
the body (6) of the container (2). The enclosing mechanism (10) in the
illustrated
example embodiment is attached to the body (6) by an attaching mechanism (24).
The
base (8) is attached to the body (6) by a second tie-layer (26).
[0045] Fig. 2 is an overhead plan schematic view of one embodiment of a
container in
accordance with the present invention showing the RFID device (22) affixed to
the
innermost surface (20) of the body (6) of the container (2).
[0046] Fig. 3 is an elevational cross-sectional schematic view of one example
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
affixed to an innermost surface (20) of the base (8) of the container. In the
illustrated
embodiment the outer layer (12) of the body (6) and the base (8) are formed as
a single
monolith, the inner layer (14) of the body (6) and the base (8) are formed as
a single
8
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
monolith and the first tie-layer (16) of the body (6) and the base (8) are
formed as a
single monolith.
[00471 Fig. 4 is an elevational cross-sectional schematic view of one example
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
affixed to an innermost surface (20) of an enclosing mechanism (10) of the
container
(2). The illustrated embodiment also shows a monolithic base (8) attached to
the body
(6) of the container (2) by a second tie-layer (26).
[00481 Fig. 5 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
comprising a supporting substrate (28) affixed to an innermost surface (20) of
the body
of the container (2).
[0049] Fig. 6 is an elevational cross-sectional schematic view of one
embodiment through a
container (2) in accordance with the present invention showing an RFID device
(22)
comprising a supporting substrate (28) affixed to an innermost surface (20) of
the base
(8) of the container (2).
[0050] Fig. 7 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
comprising a supporting substrate (28) affixed to an innermost surface of an
enclosing
mechanism (10) of the container (2).
[0051] Fig. 8 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
located in the inner layer (14) of the body (6) of the container (2).
[0052] Fig. 9 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
located in the inner layer (14) of the base (8) of the container (2).
9
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
[0053] Fig. 10 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
located in the inner layer (14) of the enclosing mechanism (10) of the
container (2).
[0054] Fig. 11 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
located in the outer layer (12) of the body (6) of the container (2).
[0055] Fig. 12 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
located in the outer layer (12) of the base (6) of the container (2).
[0056] Fig. 13 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
located in the outer layer (12) of the enclosing mechanism (10) of the
container (2).
[0057] Fig. 14 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
located between the inner layer (14) and outer layer 912) of the body 96) of
the
container (2). In the illustrated embodiment the outer layer (12) of the body
(6) and the
base (8) are formed as a single monolith, the inner layer (14) of the body (6)
and the
base (8) are formed as a single monolith and the first tie-layer (16) of the
body (6) and
the base (8) are formed as a single monolith.
[0058] Fig. 15 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
located between the inner layer (14) and outer layer (12) of the base of the
container.
[0059] Fig. 16 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
located between the inner layer (14) and outer layer (12) of the enclosing
mechanism
(10) of the container (2).
[0060] Fig. 17 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
located on the outermost surface (18) of the outer layer (12) of the body (6)
of the
container (2).
[0061] Fig. 18 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
located on the outermost surface (18) of the outer layer (12) of the base (8)
of the
container (2).
[0062] Fig. 19 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing an RFID device
(22)
located on the outer surface (18) of the outer layer (12) of the enclosing
mechanism
(10) of the container (2).
[0063] Fig. 20 is an elevational cross-sectional schematic view of one
embodiment through a
container (2) comprising a label (30) in accordance with the present invention
showing
an RFID device (22) located on the outer surface(32) of an outer layer (34) of
the label
(30).
[0064] Fig. 21 is an elevational cross-sectional schematic view of one
embodiment through a
container (2) comprising a label (30) in accordance with the present invention
showing
an RFID device (22) located in the adhesive layer of the label.
[0065] Fig 22 is an elevational cross-sectional schematic view of one
embodiment of a
container (2) in accordance with the present invention showing representative
slots (38)
and recesses (40) into which an RFID device (not shown) can be located. In the
illustrated embodiment the outer layer (12) of the body (6) and the base (8)
are formed
ll
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
as a single monolith and the inner layer (14) of the body (6) and the base (8)
are formed
as a single monolith.
DETAILED DESCRIPTION
[00661 The container comprises a body (6), a base (8), an enclosing mechanism
(10) and a
radio frequency identification (RFID) device (22). The body (6) and the base
(8) define
a cavity (4) in which the strips are stored. The body (6) of the container (2)
typically
has a proximal end, a distal end, an internal surface and an external surface.
The body
(6) of the container (2) typically has essentially a uniform cross-sectional
area when
viewed from the proximal end of the body (6); however, non-uniform cross-
sectional
areas are also possible. Usually the cross-sectional area of the body (6) as
viewed from
the proximal end of the container (2) is rectangular, elliptic or circular, so
that the form
of the body (6) is a hollow rectangular parallelepiped or is a hollow
cylinder, for
example a hollow elliptic cylinder or a hollow circular cylinder.
[0067] In some embodiments of the subject invention the body (6) of the
container (2) is a
single layer monolith. Generally the body (6) of the container (2) is produced
using a
material or materials that do not interfere with radio frequency
identification methods.
Such materials include, but are not limited to, thermoplastics such as high-
density
polyethylene or polypropylene or copolymers of ethylene or propylene. The
material
may comprise other substances and compositions such as pigments, plasticizers,
antioxidants, anti-microbial agents, mold release agents, gas barrier agents,
fillers,
sorbents, stabilizers, and flame-retardants. Materials that are useful for the
present
invention include polymers such as those described, for example, in US patent
numbers
5,723,085; 6,174,952; 6,177,183; 6,194,079; 6,221,446 and 6,316,520; and in
European
Patent publication number 1173502, the disclosures of which are incorporated
herein in
their entirety by reference. A sorbent is defined herein as a material has the
capacity or
tendency to take up liquids or gases by either absorption or adsorption.
Sorbents having
the capacity to take up water or water vapor are further defined herein as
dessicants.
Useful sorbents include molecular sieves, zeolites, diatomaceous earths,
silica gels,
12
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
hydrophilically modified silicas, and absorbent clays such as bentonite.
Useful sorbents
are further described in European patent publication numbers 0 663 793 and 0
678 054,
which are incorporated herein by reference.
[0068) In one embodiment of the invention the body (6) comprises at least one
inner layer (14)
and at least one outer layer (12), wherein the outermost surface (18) of the
outer layer
(12) partially or wholly defines the outermost surface of the body (6) and the
innermost
surface (20) of the inner layer (14) partially or wholly defines the innermost
surface of
the body (6) of the container (2). If the container (2) comprises more than
one layer
then each layer generally has an inner surface and an outer surface. The inner
layer (14)
and outer layer (12) may be of the same thickness or of different thickness
and the
thickness of each layer may be uniform or non-uniform.
[0069] The outer layer (12) is typically made of materials that do not
interfere with radio
frequency identification methods. Such materials include thermoplastics such
as high-
density polyethylene or polypropylene or copolymers of ethylene or propylene.
The
outer layer (12) may further comprise other materials such as pigments,
plasticizers,
antioxidants, anti-microbial agents, mold release agents, gas barrier agents,
fillers,
stabilizers, and flame-retardants.
[0070] The inner layer (14) is also typically made of materials that do not
interfere with radio
frequency identification methods and may comprise materials such as pigments,
plasticizers, antioxidants, anti-microbial agents, mold release agents, gas
barrier agents,
fillers, stabilizers, and flame-retardants. In a preferred embodiment the
inner layer (14)
comprises other agents for conditioning the environment in the cavity of the
container
(2), such as a sorbent and/or an anti-microbial agent.
[0071] The inner layer (14) and the outer layer (12) may be bonded together by
a first tie-layer
(16) such as an adhesive that is located between the inner and the outer layer
(12).
Suitable adhesives include hot melt adhesives and pressure sensitive
adhesives.
13
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
Alternatively, and typically if the inner and outer layers are thermoplastics,
the layers
may be bonded thermally to each other.
[0072] The container (2) is provided with a base (8) to retain the strips
within the cavity of the
container (2). The base (8) is affixed to the distal end of the body (6) of
the container
(2) and comprises an innermost surface (20) and an outermost surface (18) and
optionally comprises one or more layers. In one embodiment the base (8)
comprises
material of the same composition or compositions as the body (6) of the
container (2).
In another embodiment the base (8) comprises an inner layer (14) and an outer
layer
(12), which are optionally bonded to each other either thermally or with a
second
adhesive tie-layer (26). In yet another embodiment the inner layer (14) is of
the same
material as the inner layer (14) of the body (6) of the container (2). In
still other
embodiments the outer layer (12) is of the same material as the outer layer
(12) of the
body (6) of the container (2). In some embodiments the base (8) and body (6)
form a
monolith, for example if the body (6) of the container (2) has a single layer
and the
base (8) has a single layer then the container (2) and the base (8) can be
formed by a
process such as injection molding or blow molding as a single monolith. In
other
embodiments wherein the body (6) comprises more than one layer the base (8)
can be
formed with one or more layers of the body (6) to as a monolith. Alternatively
the base
(8) and body (6) can be formed separately and the base (8) is subsequently
affixed to
the distal end of the body (6). In this case the base (8) may be affixed to
the distal end
of the body (6) by known means such as with an adhesive or by thermal bonding.
[0073] The container (2) is usually provided with an enclosing mechanism (10).
Such
enclosing mechanisms are generally necessary to reduce the exposure of the
strips
within the cavity of the container (2) to environmental influences, such as
moisture,
light or air, which may adversely affect the performance of the strips.
Examples of
enclosing mechanisms include caps, in particular caps that can be resealed,
lids, bungs,
stoppers, films or foils. The enclosing mechanism (10) may be attached by an
attaching
mechanism (24) such as a hinge or a clip to the body (6) of the container (2)
or may be
separate from the body (6) of the container (2). Useful container and cap
assemblies are
14
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
described, for example, in PCT international publication number WO
01/15989.which
is incorporated herein by reference.
[0074] The container (2) comprises a radio frequency identification (RFID)
device. Preferably
the RFID device (22) comprises a microchip that stores information relating to
the
calibration of the analyte measurement apparatus (for example, a handheld
meter) for
use with the test sensors, such as strips, stored in the container (2), and
typically further
comprises at least one antenna for receiving, transmitting or scattering a
radio signal,
and optionally a power source such as a battery. The RFID device (22)
optionally
comprises a pliable supporting substrate (28) onto which the antenna,
microchip and
optional power source are affixed to form a tag.
[0075] In one embodiment of the present invention the RFID device (22) is
present in the
cavity of the container (2). In some example embodiments the RFID device (22)
is
affixed to the innermost surface (20) of the body (6) (see Fig. 1.), base (8)
(see Fig. 3)
and/or enclosing mechanism (10) (see Fig. 4) of the container (2). In some
example
embodiments the inner layer (14) provides the supporting substrate (28) for
the RFID
device (22). In other example embodiments an RFID device comprising a
supporting
substrate (28) is affixed to the innermost surface (20) of the container (2)
(see Fig. 5,
Fig. 6 and Fig 7.). In yet further embodiments of the present invention
wherein the
container (2) comprises an inner layer (14) and an outer layer (12), the inner
layer (14)
and the outer layer (12) may be present in the body (6), base (8) or enclosing
mechanism (10) of the container (2) or any combination of these, and the RFID
device
(22) is present in the inner layer (14) (see Fig. 8, Fig. 9 and Fig. 10). In
such
embodiments the RFID device (22) is generally not exposed to the contents of
the vial
and may be protected from damage from mechanical, electrical or other
influences. In
still further embodiments the RFID device (22) is present in an outer layer
(12) of the
body (6), base (8) or enclosing mechanism (10) of the container (2) (see Fig.
11, Fig.
12 and Fig. 13). In yet another embodiment the RFID device (22) is located in
or on a
slot (38) or recess (40) provided in any of the layers of the body (6), base
(8) or
enclosing mechanism (10) of the container (2) (See Fig. 22). Alternatively the
RFID
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
device (22) is embedded in the material of which the inner layer (14) or outer
layer (12)
is composed. In many embodiments the RFID device (22) is present between an
inner
layer (14) and an outer layer (12) of the container (2) (Fig. 14, Fig 15 and
Fig. 16). In
another embodiment of the present invention the RFID device (22) is affixed to
the
outermost surface (18) of an outer layer (12) of the container (2) (Fig. 17
fig 18. and
Fig 19).
100761 The choice of location for the RFID device (22) in or on the container
(2) depends in
part upon the process used to manufacture the container (2). For example, in
one
embodiment of the invention the body (6), base (8) or enclosing mechanism (10)
of the
container (2) is produced by a process such as extrusion, co-extrusion,
extrusion
lamination, extrusion coating, co-molding or two-shot molding, and the RFID
device
(22) is incorporated into the extruded material of the body (6) during the
extrusion
process. The term monolith, as used herein, refers to a component or
components of the
container (2) formed from typically homogeneous material as a single entity.
In one
example embodiment, the container (2) is wholly or partly produced by a
process
comprising a two-shot molding step wherein an inner layer (14) is produced,
optionally
as a monolith, an RFID device (22) is located on the outermost surface of the
inner
layer (14) or within the inner layer (14), optionally embedded within the
inner layer
(14), and an outer layer (12) is molded, typically as a monolith around the
inner layer
(14). In another example embodiment, the container (2) is wholly or partly
produced by
a process comprising a two-shot molding step wherein an outer layer (12) is
produced,
typically as a monolith, an RFID device (22) is located the innermost surface
of the
outer layer (12) or within the outer layer (12), optionally embedded within
the outer
layer (12), and an inner layer (14) is molded, optionally as a monolith,
within the outer
layer (12). In another embodiment the container body (6) comprises an outer
layer (12)
and an inner layer (14) wherein the inner layer (14) and the outer layer (12)
are formed
separately and the inner layer (14) is mechanically inserted into the outer
layer (12) of
the body (6), such that the outer layer (12) forms a sheath around the inner
layer (14),
then the RFID device (22) may be optionally temporarily or permanently affixed
to the
inner surface of the outer layer (12) or to the outer surface of the inner
layer (14) prior
16
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
to insertion of the inner layer (14), so that the RFID device (22) is present
between the
two layers in the produced container (2).
[0077] Fig 22. is an example embodiment of a container showing representative
slots (38) and
recesses (40) into which an RFID device (22) (not shown) can be inserted.
[0078] The choice of location of the RFID device (22) is also determined in
part by the desire
to protect the RFID device (22) from environmental influences. For example, if
the
external surface of the container (2) is exposed to mechanical handling then
the RFID
device (22) is optionally not located on the outer surface of an outer layer
(12) of the
container (2). Alternatively if it is desirable to protect the RFID device
(22) from
exposure to the contents of the container (2) then the RFID device (22) is
optionally not
affixed to the inner surface of an inner layer (14) of the container (2).
Therefore, in
certain circumstances it may be advantageous to locate the RFID device (22)
within the
inner layer (14), within the outer layer (12) or between the inner and outer
layers as
herein described. Indeed, in one aspect of the invention the RFID device (22)
is located
optionally between the outermost surface (18) of the container (2) and the
innermost
surface (20) of the container (2) such that where two or more layers are
provided, the
RFID device (22) is located between the outermost (18) surface of the outer
layer (12)
and the innermost surface (20) of the inner layer (14). Methods of
manufacturing the
body (6), enclosing mechanism (10) or base (8) of the container (2) or
assemblies
thereof are generally known in the art and are described, for example, in US
patent
numbers 5,911,937; 6,769,558; 4,783,056; 4, 812,116 and 5,723,085 the
disclosures of
which are incorporated herein by reference. The person of ordinary skill will
understand that these methods can be readily adapted to include an RFID device
(22).
[0079] The container (2) may further comprise a label (30) that is affixed to
the body (6), the
enclosing mechanism (10) or the base (8) of the container (2). Preferably the
label (30)
is affixed to an outer surface of the container (2). Typically the label (30)
comprises an
adhesive layer for affixing the label (30) to the outer surface of the
container (2). In
some embodiments the RFID device (22) is present in or on the label (30) (see
Fig 19)
17
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
or in the adhesive layer (see Fig. 20) of the label (30). The label (30) may
further
comprise other features such as information about the contents of the
container (2). In
some embodiments the label (30) covers partly or wholly the outer surface of
an outer
layer (12) of the container (2). -In yet other embodiments the label (30)
displays the
calibration information of the test strip container (2). In such embodiments
the user is
generally provided with a visual means of comparing the calibration
information on the
label (30) with a reading on the meter that displays the calibration
information.
[0080] The container (2) is designed to store the test strips in an
unsystematic manner or in a
systematic manner. An example of a container (2) that is used to store strips
in an
unsystematic manner is a vial. The strips, which are typically between about
10 and
about 40 millimeters (mm) in length and typically from about 3 to about 10 mm
in
width, are placed in the vial that is longer and wider than the individual
strips.
Typically the vial is from about 15 mm to about 50 mm in length, and from
about 5mm
to about 30 mm in width. The test strips are generally not orientated by any
means
other than the form of the cavity of the vial. An example of a container (2)
that is used
to store the vial in a systematic manner is a cartridge. Such a cartridge is a
container (2)
into which the strips are inserted in a systematic manner, for instance as a
stack of
strips. The container (2) may also be provided with a strip dispensing
mechanism and a
mechanism for urging the strips towards the dispensing mechanism.
[0081] The container (2) may be stored within the analytical device. The
container (2) may
have a functional interaction with the analytical device for delivering strips
to a testing
position or it may not.
[0082] The subject invention is particularly useful when the test strips are
for use in the
measurement of analytes such as glucose or cholesterol, although other
analytes can
also be measured. Fluids that are of particular interest include biological
fluids such as
whole blood, or a fraction or derivative thereof, interstitial fluid, urine or
sweat. Non-
biological fluids that can be used with the test strips include control fluids
of known
4
lO
CA 02634613 2008-06-20
WO 2007/072009 PCT/GB2006/004843
analyte concentration that are typically used to check the performance of the
analyte
measuring apparatus.
[0083] One aspect of the present invention relates to a method for reducing
the risk that
calibration information is entered incorrectly into a test meter, wherein a
container (2)
comprising an RFID device (22). having calibration information stored on a
microchip
that accounts for the performance variability of test strips present in the
container (2),
and a meter provided with a radio transmitter and receiver and a means for
converting
received radio signals into calibration parameters for the meter, are brought
into close
proximity, preferably within a distance of about 0 meters (m) to about 100 m,
more
preferably between about 0 m and about 0.1 m, whereupon a means of
transferring the
calibration information is actuated to transfer the calibration information as
a radio or
microwave signal from the microchip to the receiver. For example, in one use,
a meter
provided with a radio transmitter and receiver and a means for converting
received
radio signals into calibration parameters for the meter is brought into close
proximity to
a container (2) of the present invention. The RFID device (22) of the
container (2)
stores calibration information that accounts for the performance variability
of the strips
present in the container (2), the calibration information stored on the
microchip having
previously been calculated at about the same time that the strips were tested
during
manufacturing. A means of transferring the calibration information is then
actuated,
such as a radio signal transmitting, receiving and processing circuit in the
meter, which
causes the calibration information to be transferred from the microchip to the
receiver
of the meter. Thus the user therefore does not have to manually enter
calibration
information relating to the test strips in the container (2) into the meter.
[0084] It should be understood that various alternatives to the embodiments of
the invention
described herein may be employed in practicing the invention. It is intended
that the
following claims define the scope of the invention and that methods and
structures
within the scope of these claims and their equivalents be covered thereby.
4
19
