WO2007072009A2

WO2007072009A2 - Container with rfid device for storing test sensors

Info

Publication number: WO2007072009A2
Application number: PCT/GB2006/004843
Authority: WO
Inventors: Grenville Robinson; John Mcinulty; Damien Baskeyfield; Tom O'reilly
Original assignee: Lifescan Scotland, Ltd
Priority date: 2005-12-22
Filing date: 2006-12-21
Publication date: 2007-06-28
Also published as: CN101375159A; WO2007072009A3; JP2009520973A; CA2634613A1; CN101375159B; EP1963846A2; GB0526216D0; GB2433926A

Abstract

The subject invention relates to containers provided with RFID devices for storing test strips, wherein the RFID device is located between the outermost surface and the innermost surface of the container.

Description

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 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 incorrect 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 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. [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 a 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 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. 1 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. [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 comprising 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.

[0032] 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. [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.

[0037] 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.

[0040] 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. [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 inner 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 monolith and the first tie-layer (16) of the body (6) and the base (8) are formed as a single monolith.

[0047] 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 RPID 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).

[0048] 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). [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 RPID 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 RPID 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 RPID 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 RPID 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) 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 RPID 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 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

[0066] 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 1 173502, 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, 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. 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 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 (RPID) 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 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).

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 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) 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 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.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. 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.

2. A container according to claim 1 wherein the container comprises at least one layer of material and the radio frequency identification device is embedded therein.

3. A container according to claim 2 wherein at least one layer comprises a sorbent.

4. A container according to claim 3 wherein the sorbent comprises bentonite or a hydrophillically modified silica.

5. A container according to any of the preceding claims wherein the container comprises a polyolefin composition.

6. A container according to claim 5 wherein the polyolefin composition comprises polypropylene.

7. A container comprising a cavity wherein a radio frequency identification device is located within the cavity.

8. A container according to claim 7 wherein the radio frequency identification device is located on an innermost surface of the container.

9. A container according to any of the preceding claims wherein the container comprises two or more layers and a radio frequency identification device is located within an outer layer.

10. A container according to claim 9 wherein the radio frequency identification device is embedded in the outer layer.

11. A container according to any of the preceding claims wherein the container comprises two or more layers and a radio frequency identification device is located within an inner layer.

12. A container according to claim 9 wherein the radio frequency identification device is embedded in the inner layer.

13. A container according to any of the preceding claims wherein the container comprises two or more layers and a radio frequency identification device is located between an inner layer and an outer layer.

14. A container according to any of the preceding claims wherein container comprises two or more layers and the radio frequency identification device is located within an enclosing mechanism.

15. A container according to any one of the preceding claims further comprises a label having a radio frequency identification device.

16. A container according to claim 15 wherein the label comprises an adhesive suitable for affixing the label.

17. The container of claim 15 or claim 16 wherein the radio frequency identification device is present on the outermost surface of the label

18. The container of claim 16 wherein the radio frequency identification device is located in or adjacent to the label adhesive.

19. A container according to any of the preceding claims 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.

20. A method for entering calibration information into a test meter, wherein a container comprising an RFID device (22) 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 information is actuated to transfer the calibration information as a radio or microwave signal from the microchip to the receiver .