WO2006102306A1 - Packaging container for test sensors - Google Patents

Packaging container for test sensors Download PDF

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Publication number
WO2006102306A1
WO2006102306A1 PCT/US2006/010189 US2006010189W WO2006102306A1 WO 2006102306 A1 WO2006102306 A1 WO 2006102306A1 US 2006010189 W US2006010189 W US 2006010189W WO 2006102306 A1 WO2006102306 A1 WO 2006102306A1
Authority
WO
WIPO (PCT)
Prior art keywords
housing
test sensor
packaging container
test
containing regions
Prior art date
Application number
PCT/US2006/010189
Other languages
French (fr)
Inventor
Weiping Zhong
Nestor Garcia-Gaisbichler
Original Assignee
Bayer Healthcare Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bayer Healthcare Llc filed Critical Bayer Healthcare Llc
Priority to EP06739110A priority Critical patent/EP1877778A1/en
Priority to US11/886,276 priority patent/US20080093235A1/en
Publication of WO2006102306A1 publication Critical patent/WO2006102306A1/en

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/4875Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G01N33/48778Containers specially adapted therefor, e.g. for dry storage

Definitions

  • the present invention relates generally to a packaging container for test sensors and, more particularly, to a circular packaging container for test sensors to be used in conjunction with a liquid sample monitoring device to provide an analyte concentration in a liquid sample.
  • self- testing systems are used for determining the presence or concentration of other analytes in body fluids, such as, for example, cholesterol, alcohol, and hemoglobin in blood, interstitial fluid, or chemical substances in saliva.
  • One method of monitoring a person's blood glucose level is with a portable, handheld, blood glucose testing device.
  • the portable nature of these devices enables users to conveniently test their blood glucose levels wherever the users may be.
  • the test device receives a test sensor for harvesting the blood for analysis.
  • the test sensor one of which is required for each test, contains a reaction area including a reagent for producing a measurable reaction with the glucose indicative of the blood glucose concentration level.
  • the test sensor harvests the blood for reaction with the reagent stored within.
  • Prior art test devices exist that contain a plurality of test sensors or test strips in either a circular sensor packaging container or a cartridge sensor packaging container.
  • An exemplary prior art circular sensor packaging container is disclosed in U.S. Patent No. 5,575,403.
  • a plane parallel to the width of the test sensor is parallel to a plane running through the top portion of the housing of the sensor packaging container.
  • One drawback with prior art circular sensor packaging container is the limited number of test sensors contained in the container. The number of test sensors contained in the sensor packaging container is limited by the physical space available for the sensor packaging container within the handheld test device. Therefore, a need exists for a circular sensor packaging container that contains a greater number of test sensors without needing to dramatically increase the physical space taken up within the handheld test device by the circular sensor packaging container.
  • a test sensor packaging container for use in sensor instrument.
  • the test sensor packaging container comprises a housing, a first foil cover, and a second foil cover.
  • the housing has a first housing layer and a second housing layer.
  • the first housing layer has a first plurality of test sensor containing regions. Each of the first plurality of test sensor containing regions protrude radially outward from the center of the housing.
  • the second housing layer has a second plurality of test sensor containing regions. Each of the second plurality of test sensor containing regions protrude radially outward from the center of the housing.
  • the housing has a top portion and a bottom portion that are generally parallel. Each of the test sensors has a width direction and a thickness direction.
  • the first foil cover is adapted to cover the top portion of the first housing layer of the housing.
  • the second foil cover is adapted to cover the bottom portion of the second housing layer.
  • a test sensor packaging container for use in sensor instrument.
  • the test sensor packaging container comprises a housing, a first foil cover, and a second foil cover.
  • the housing has a first housing layer and a second housing layer.
  • the first housing layer has a first plurality of test sensor containing regions and a first plurality of desiccant cavities in fluid communication with each of the first plurality of test sensor containing regions.
  • the second housing layer has a second plurality of test sensor containing regions and a second plurality of desiccant cavities in fluid communication with each of the second plurality of test sensor containing regions.
  • Each of the first and second plurality of test sensor containing regions has a proximal end and a distal end and is adapted to contain a test sensor.
  • the first and second plurality of test sensor containing regions protrude radially outward from the center of the housing.
  • the housing has a top portion and a bottom portion that are generally parallel.
  • Each of the test sensors has a width direction and a thickness direction.
  • the first foil cover is adapted to cover the top portion of the first housing layer of the housing.
  • the second foil cover is adapted to cover the bottom portion of the second housing layer of the housing.
  • the third foil cover is adapted to cover the distal end of the first plurality of test sensor containing regions.
  • the fourth foil cover is adapted to cover the distal end of the second plurality of test sensor containing regions.
  • a plane generally parallel to the width direction of each of the plurality of test sensors is generally perpendicular to the top and bottom portion of the housing.
  • a test sensor packaging container for use in sensor instrument.
  • the test sensor packaging container comprises a molded polymeric housing, a first foil cover, and a second foil cover.
  • the housing has a first housing layer and a second housing layer.
  • the first housing layer has a first plurality of test sensor containing regions and a first plurality of desiccant cavities in fluid communication with each of the first plurality of test sensor containing regions.
  • the second housing layer has a second plurality of test sensor containing regions and a second plurality of desiccant cavities in fluid communication with each of the second plurality of test sensor containing regions.
  • Each of the first and second plurality of test sensor containing regions has a proximal end and a distal end and.
  • the housing has a top portion and a bottom portion that are generally parallel.
  • Each of the test sensors has a width direction and a thickness direction.
  • the first foil cover is adapted to cover the top portion of the first housing layer of the housing.
  • the second foil cover is adapted to cover the bottom portion of the second housing layer of the housing.
  • the third foil cover is adapted to cover the distal end of the first plurality of test sensor containing regions.
  • the fourth foil cover is adapted to cover the distal end of the second plurality of test sensor containing regions.
  • a plane generally parallel to the width direction of each of the plurality of test sensors is generally perpendicular to the top and bottom portion of the housing.
  • FIG. 1 is a top view of a circular sensor packaging container according to one embodiment of the present invention.
  • FIG. 2 is a side view of the circular sensor packaging container of FIG. 1.
  • FIG. 3 is a top view of a circular sensor packaging container according to another embodiment of the present invention.
  • FIG. 4 is a side view of the circular sensor packaging container of FIG. 3.
  • FIGS. 5a-c show a partial cross-sectional view of a test sensor being dispensed from the circular sensor packaging container of FIG. 3 according to one embodiment of the present invention.
  • FIGS. 6a-b show a partial cross-sectional view of a test sensor being dispensed from the circular sensor packaging container of FIG. 3 according to another embodiment of the present invention.
  • FIG. 7 is a top view of a circular sensor packaging container according to a further embodiment of the present invention.
  • FIG. 8 is a side view of the circular sensor packaging container of FIG. 7.
  • FIG. 9 is a top view of a circular sensor packaging container according to yet another embodiment of the present invention.
  • FIG. 10 is a side view of the circular sensor packaging container of FIG. 9.
  • a circular sensor packaging container 10 for holding a plurality of test sensors 12 used in determining a user's analyte concentration level in a fluid sample is shown according to one embodiment of the present invention. While the following discussion describes the use of test sensors for determining the glucose concentration in blood, it is understood that the present invention maybe employed in determining the concentration of other analytes in other types of samples. Analytes that may be measured using the present invention include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin A 1 c , fructose, lactate, or bilirubin.
  • lipid profiles e.g., cholesterol, triglycerides, LDL and HDL
  • microalbumin e.g., microalbumin
  • hemoglobin A 1 c e.g., fructose, lactate, or bilirubin.
  • the present invention is not limited, however, to these specific analytes and it is contemplated that other analyte concentrations may be determined.
  • the analytes may be in, for example, a whole blood sample, a blood serum sample, a blood plasma sample, or other body fluids like ISF (interstitial fluid) and urine.
  • the sensor packaging container 10 comprises a housing 14 having a first housing layer 16 and a second housing layer 18.
  • the first housing layer 16 having a plurality of first test sensor containing regions 20.
  • the second housing layer 18 having a plurality of second test sensor containing regions 22.
  • Each of the plurality of first and second test sensor containing regions 20, 22 contain a single test sensor 12.
  • the housing 14 has a first foil cover 24 that is adapted to cover the first housing layer 16 of the packaging container 10, sealing each of the plurality of test sensors 12 within the plurality of first test sensor containing regions 20 of the container 10.
  • the housing 14 has a second foil cover 26 that is adapted to cover the second housing layer 18 of the packaging container 10, sealing each of the plurality of test sensors 12 within the plurality of second test sensor containing regions 22 of the container 10.
  • the housing 14 and the first and second foil covers 24, 26 completely seal the test sensor 12 from environment.
  • the test sensor 12 has an angled face 13 for piercing the respective foil covers 24, 26 covering the first or second test sensor containing region 20, 22 of the container 10.
  • a plurality of first desiccant cavities 28 is in fluid communication with each of the corresponding first sensor containing regions 20. Additionally, a plurality of second desiccant cavities 30 are in fluid communication with ach of the corresponding second sensor containing regions 22.
  • Desiccant material is disposed in the desiccant cavities 28, 30 in order to ensure that the sensor containing regions 20, 22 are maintained at an appropriate humidity level so that the reagent material in the test sensor 12 disposed in the particular sensor containing regions 20, 22 is not adversely affected prior to being used.
  • the desiccant material might be in the form of a small bag or a bead of material or any other form that can be readily disposed in the plurality of desiccant cavities 28, 30.
  • the first desiccant cavities 28 are each in fluid communication with only a single first sensor containing region 20. As a result, the opening of one of the first sensor containing regions 20 will not affect the desiccated state of any of the other first sensor containing regions 20.
  • second desiccant cavities 30 are each in fluid communication with only a single second sensor containing region 22. As a result, the opening of one of the second sensor containing regions 22 will not affect the desiccated state of any of the other second sensor containing regions 22. [0024] As is shown in FIG.
  • the test sensor 12 is positioned within the plurality of sensor containing regions 16 of the packaging container 10 such that a plane generally parallel to the width of the test sensor 12 is also generally parallel to the plane of the first and second foil covers 24, 26.
  • the test sensor packaging container 10 is adapted to contain from about fifteen (15) to about twenty five (25) test sensors 12. More specifically, the test sensor packaging container 10 is adapted to contain about twenty (20) test sensors 12.
  • the test sensor packaging container 10 has a diameter D. The diameter D may range from about 40 mm to about 60 mm.
  • the diameter D may range from about 50 mm to about 55 mm.
  • the test sensor packaging container 10 has a thickness T.
  • the thickness T of the packaging container 10 may range from about 2 mm to about 8 mm. More specifically, the thickness T of the test sensor packaging container is about 4 mm.
  • the sensor packaging container 110 for holding a plurality of test sensors 12 used in determining a user's analyte concentration level in a fluid sample is shown according to another embodiment of the present invention.
  • the sensor packaging container 110 comprises a housing 114 having a first housing layer 116 and a second housing layer 118.
  • the first housing layer 114 has a plurality of first test sensor containing regions 120.
  • the second housing layer 118 has a plurality of second test sensor containing regions 122.
  • Each of the plurality of first and second test sensor containing regions 120, 122 contains a single test sensor 12.
  • the plurality of test sensor containing regions 120, 122 protrudes out from the center of the housing 114.
  • An open region 132 is formed between each of the plurality of sensor containing regions 120, 122.
  • the sensor containing regions 120, 122 and the open regions 132 forms a generally gear shaped pattern on the sensor packaging container 110.
  • the first housing layer 116 has a first foil cover 124 that is adapted to cover the top portion of the first housing layer 116 of the packaging container 110, sealing the test sensor 12 within the container 110.
  • the first housing layer 116 has a third foil cover 134 that is adapted to cover a distal end of the plurality of first sensor containing regions 120 of the first housing layer 116, further sealing the test sensor 12 within the packaging container 110.
  • the first housing layer 116 and the first and third foil covers 124, 134 completely seal the test sensor 12 of the first housing layer 116 from environment.
  • the second housing layer 118 has a second foil cover 126 that is adapted to cover the bottom portion of the second housing layer 118 of the packaging container 110, sealing the test sensor 12 within the container 110.
  • the second housing layer 118 has a fourth foil cover 136 that is adapted to cover a distal end of the plurality of second sensor containing regions 122 of the second housing layer 118, further sealing the test sensor 12 within the packaging container 110.
  • the second housing layer 118 and the second and fourth foil covers 126, 136 completely seal the test sensor 12 of the second housing layer 118 from environment.
  • the test sensor 12 has an angled face 13 for piercing the respective foil covers 134, 136 covering the distal end of the first or second test sensor containing region 120, 122 of the container 110.
  • a plurality of first desiccant cavities 128 is in fluid communication with each of the corresponding first sensor containing regions 120. Additionally, a plurality of second desiccant cavities 130 is in fluid communication with ach of the corresponding second sensor containing regions 122.
  • Desiccant material is disposed in the desiccant cavities 128, 130 in order to ensure that the sensor containing regions 120, 122 are maintained at an appropriate humidity level so that the reagent material in the test sensor 12 disposed in the particular sensor containing regions 120, 122 is not adversely affected prior to being used.
  • the desiccant material might be in the form of a small bag or a bead of material or any other form that can be readily disposed in the plurality of desiccant cavities 128, 130.
  • the first desiccant cavities 128 are each in fluid communication with only a single first sensor containing region 120. As a result, the opening of one of the first sensor containing regions 120 will not affect the desiccated state of any of the other first sensor containing regions 120.
  • second desiccant cavities 130 are each in fluid communication with only a single second sensor containing region 122. As a result, the opening of one of the second sensor containing regions 122 will not affect the desiccated state of any of the other second sensor containing regions 122.
  • the housing 114 of the test sensor packaging container 110 comprises a molded polymeric material according to one embodiment of the present invention. Using a molded polymeric material for the housing 114 increases the structural rigidity of the test sensor packaging container 110. The increased structural rigidity of the housing 114 provided by using a molded polymeric material to form the housing 114 allows the open regions 132 located between each of the plurality of sensor containing regions 120, 122 to be used to align the test sensor packaging container 110 within a testing device. [0032] As is shown in FIG.
  • the test sensor 12 is positioned within the plurality of sensor containing regions 120, 122 of the packaging container 110 such that a plane generally parallel to the width of the test sensor 12 is generally perpendicular to the plane of the top portion of the housing 114 of the test sensor packaging container 110. Arranging the test sensor 12 in such a configuration reduces the amount of space along the periphery of the housing 114 required for each test sensor 12 as the test sensors 12 have a width that is greater than their thickness. Therefore, additional test sensors 12 may be placed within the packaging container 110. hi this way the diameter of the test sensor packaging container 110 does not dramatically increase in order to increase the number of test sensors 12 held by the test sensor packaging container 110.
  • the test sensor packaging container 110 is adapted to contain from about fifty (50) to about seventy (70) test sensors 12. More specifically, the test sensor packaging container is adapted to contain about sixty (60) test sensors 12.
  • the test sensor packaging container 110 has a diameter D'. The diameter D' may range from about 40 mm to about 55 mm. More specifically, the diameter D' may range from about 45 mm to about 50 mm.
  • the test sensor packaging container 110 has a thickness T'. The thickness T' of the packaging container 110 may range from about 2 mm to about 6 mm. More specifically, the thickness T' of the test sensor packaging container is about 4 mm.
  • FIGs. 5a-c the dispensing of one of the test sensors 12 of the first housing layer 116 of test sensor packaging container 110 is shown.
  • the test sensor packaging container 110 is shown in conjunction with a knife assembly 160.
  • the knife assembly 160 has generally a "T" shape, however, other shapes may be used for knife assembly 160.
  • the knife assembly 160 is positioned above the first foil cover 124 of one of the plurality of first test sensor containing regions 120.
  • the knife assembly 160 is adapted move in the direction of arrow A to puncture the first foil cover 124 of the packaging container 110.
  • FIG. 5b shows the knife assembly 160 after it punctures the first foil cover 124 and position the knife assembly 160 within one of the first test sensor containing regions 120.
  • FIG. 5c shows the test sensor 12 after it has been dispensed from the first test sensor containing region 120 of the packaging container 110.
  • the knife assembly 160 moves in the direction shown by arrow B in a radial direction towards the distal end of the first test sensor containing region 120 of the packaging container 110.
  • As the knife assembly 160 moves in the direction of arrow B it contact the test sensor 12, forcing the test sensor 12 towards the distal end of the first test sensor containing region 120.
  • the test sensor 12 contains an angled face 13 that contacts the third foil cover 134 of the packaging container 110.
  • the angled face 13 of the test sensor 12 is adapted to puncture the third foil cover 134 of the packaging container 110. As the knife assembly 160 moves, it continues to puncture the first foil cover 124 covering the first test sensor containing region 120 corresponding to the test sensor 12 being dispensed.
  • FIGs. 6a and 6b the dispensing of one of the test sensors 12 of the first housing layer 116 of the test sensor packaging container 110 is shown.
  • the test sensor packaging container 110 is shown in conjunction with a knife assembly 162.
  • the knife assembly 162 is positioned at a proximal end of one of the plurality of first test sensor containing regions 120.
  • the knife assembly 162 is adapted to slide outward in a radial direction, as shown by arrow C, from the proximal end of one of the plurality of first test sensor containing regions 120 towards the distal end of one of the first test sensor containing regions 120.
  • FIG. 1 the knife assembly 162 is positioned at a proximal end of one of the plurality of first test sensor containing regions 120.
  • the knife assembly 162 is adapted to slide outward in a radial direction, as shown by arrow C, from the proximal end of one of the plurality of first test sensor containing regions 120 towards the distal end of one of the first test sensor
  • the test sensor 12 is shown after it has been dispensed from one of the first test sensor containing regions 120 of the packaging container 110.
  • the knife assembly 162 moves in the direction of arrow C towards the distal end of one of the first test sensor containing regions 120 of the packaging container 110. As the knife assembly 162 moves, it contact the test sensor 12 forcing the test sensor 12 towards the distal end of the test sensor containing region.
  • the test sensor 12 contains an angled face 13 that contacts the third foil cover 134 of the packaging container 110. The angled face 13 of the test sensor 12 is adapted to puncture the third foil cover 134 of the packaging container 10.
  • the sensor packaging container 710 for holding a plurality of test sensors 12 used in determining a user's analyte concentration level in a fluid sample is shown according to another embodiment of the present invention.
  • the sensor packaging container 710 comprises a housing 714 having a first housing layer 716 and a second housing layer 718.
  • the first housing layer 716 having a plurality of first test sensor containing regions 720.
  • the second housing layer 718 having a plurality of second test sensor containing regions 722.
  • Each of the plurality of first and second test sensor containing regions 720, 722 contain a single test sensor 12.
  • the housing 714 has a first foil cover 724 that is adapted to cover the first housing layer 716 of the packaging container 710, sealing each of the plurality of test sensors 12 within the plurality of first test sensor containing regions 720 of the container 710. Additionally, the housing 714 has a second foil cover 726 that is adapted to cover the second housing layer 718 of the packaging container 710, sealing each of the plurality of test sensors 12 within the plurality of second test sensor containing regions 722 of the container 710.
  • the housing 714 and the first and second foil covers 724, 726 completely seal the test sensor 12 from environment.
  • the test sensor 12 has an angled face 13 for piercing the respective foil covers 724, 726 covering the first or second test sensor containing region 720, 722 of the container 710.
  • a plurality of first desiccant cavities 728 is in fluid communication with each of the corresponding first sensor containing regions 720. Additionally, a plurality of second desiccant cavities 730 are in fluid communication with ach of the corresponding second sensor containing regions 722.
  • the desiccant cavities 728, 730 are located at the proximal end of the sensor containing regions 720, 722.
  • Desiccant material is disposed in the desiccant cavities 728, 730 in order to ensure that the sensor containing regions 720, 722 are maintained at an appropriate humidity level so that the reagent material in the test sensor 12 disposed in the particular sensor containing regions 720, 722 is not adversely affected prior to being used.
  • the desiccant material might be in the form of a small bag or a bead of material or any other form that can be readily disposed in the plurality of desiccant cavities 728, 730.
  • the first desiccant cavities 728 are each in fluid communication with only a single first sensor containing region 720. As a result, the opening of one of the first sensor containing regions 720 will not affect the desiccated state of any of the other first sensor containing regions 720.
  • second desiccant cavities 730 are each in fluid communication with only a single second sensor containing region 722. As a result, the opening of one of the second sensor containing regions 722 will not affect the desiccated state of any of the other second sensor containing regions 722.
  • the test sensor 12 is positioned within the plurality of sensor containing regions 716 of the packaging container 710 such that a plane generally parallel to the width of the test sensor 712 is also generally parallel to the plane of the first and second foil covers 724, 726.
  • the test sensor packaging container 710 is adapted to contain from about fifteen (15) to about twenty five (25) test sensors 12. More specifically, the test sensor packaging container 710 is adapted to contain about twenty (20) test sensors 12.
  • the test sensor packaging container 710 has a diameter D.
  • the diameter D may range from about 40 mm to about 60 mm. More specifically, the diameter D may range from about 50 mm to about 55 mm.
  • the test sensor packaging container 710 has a thickness T.
  • the thickness T of the packaging container 710 may range from about 2 mm to about 8 mm. More specifically, the thickness T of the test sensor packaging container 710 is about 4 mm.
  • the sensor packaging container 910 for holding a plurality of test sensors 12 used in determining a user's analyte concentration level in a fluid sample is shown according to a further embodiment of the present invention.
  • the sensor packaging container 910 comprises a housing 914 having a first housing layer 916 and a second housing layer 918.
  • the first housing layer 916 has a plurality of first test sensor containing regions 920.
  • the second housing layer 918 has a plurality of second test sensor containing regions 922.
  • Each of the plurality of first and second test sensor containing regions 920, 922 contains a single test sensor 912.
  • the housing 914 has a first foil cover 924 that is adapted to cover the first housing layer 916 of the packaging container 910, sealing each of the plurality of test sensors 12 within the plurality of first test sensor containing regions 920 of the container 910. Additionally, the housing 914 has a second foil cover 926 that is adapted to cover the second housing layer 918 of the packaging container 910, sealing each of the plurality of test sensors 12 within the plurality of second test sensor containing regions 922 of the container 910.
  • the housing 914 and the first and second foil covers 924, 926 completely seal the test sensor 12 from environment.
  • the test sensor 12 has an angled face 13 for piercing the respective foil covers 924, 926 covering the first or second test sensor containing region 920, 922 of the container 910.
  • a plurality of first desiccant regions 928 is in fluid communication with each of the corresponding first sensor containing regions 920. Additionally, a plurality of second desiccant regions 930 is in fluid communication with ach of the corresponding second sensor containing regions 922.
  • Desiccant material is disposed in the desiccant regions 928, 930 in order to ensure that the sensor containing regions 920, 922 are maintained at an appropriate humidity level so that the reagent material in the test sensor 12 disposed in the particular sensor containing regions 920, 922 is not adversely affected prior to being used.
  • the desiccant material of the desiccant regions 928,930 is in the form of a hot-melt desiccant.
  • the hot-melt desiccant is molded into the housing 914 of the test sensor packaging container 910. Using a hot-mold desiccant material simplifies the manufacturing of the packaging container 910 by avoiding the need to fill a desiccant cavity with a desiccant material.
  • the hot-melt desiccant also may be formed in a wide variety of shapes, giving greater flexibility in the positioning of the desiccant.
  • the first desiccant regions 928 are each in fluid communication with only a single first sensor containing region 920. As a result, the opening of one of the first sensor containing regions 920 will not affect the desiccated state of any of the other first sensor containing regions 920.
  • second desiccant regions 930 are each in fluid communication with only a single second sensor containing region 922. As a result, the opening of one of the second sensor containing regions 922 will not affect the desiccated state of any of the other second sensor containing regions 922.
  • the test sensor 12 is positioned within the plurality of sensor containing regions 916 of the packaging container 910 such that a plane generally parallel to the width of the test sensor 12 is also generally parallel to the plane of the first and second foil covers 924, 926.
  • the test sensor packaging container 910 is adapted to contain from about fifteen (15) to about twenty five (25) test sensors 12. More specifically, the test sensor packaging container 910 is adapted to contain about twenty (20) test sensors 12.
  • the test sensor packaging container 910 has a diameter D. The diameter D may range from about 40 mm to about 60 mm. More specifically, the diameter D may range from about 50 mm to about 55 mm.
  • the test sensor packaging container 910 has a thickness
  • the thickness T of the packaging container 910 may range from about 2 mm to about 8 mm. More specifically, the thickness T of the test sensor packaging container 910 is about 4 mm.
  • a test sensor packaging container for use in a sensor instrument for handling a plurality of test sensors, the test sensor packaging container comprising: a housing having first housing layer and a second housing layer, the first housing layer having a first plurality of test sensor containing regions, each of the first plurality of test sensor containing regions being adapted to contain one of the plurality of test sensors, each of the first plurality of test sensor containing regions protruding radially outward from the center of the housing, the second housing layer having a second plurality of sensor containing regions, each of the second plurality of test sensor containing regions protruding radially outward from the center of the housing, the housing having a top portion and a bottom portion that are generally parallel, each of the plurality of test sensors having a width direction and a thickness direction; a first foil cover adapted to cover the top portion of the first housing layer of the housing; and a second foil cover adapted to cover the bottom portion of the second housing layer of the housing.
  • test sensor packaging container of Alternative Embodiment A further comprising a plurality of first desiccant cavities in fluid communication with each of the first test sensor containing regions; and a plurality of second desiccant cavities in fluid communication with each of the second sensor containing regions.
  • test sensor packaging container of Alternative Embodiment B further having desiccant material in each of the plurality of first and second desiccant cavities such that each of the test sensor containing regions is maintained in a desiccate state.
  • test sensor packaging container of Alternative Embodiment A wherein the housing has from about fifteen (15) to about twenty five (25) test sensor containing regions.
  • test sensor packaging container of Alternative Embodiment D wherein the housing has about twenty (20) test sensor containing regions.
  • test sensor packaging container of Alternative Embodiment A wherein the housing has a diameter from about 40 mm to about 60 mm.
  • test sensor packaging container of Alternative Embodiment A wherein the housing has a thickness of from about 2 mm to about 8 mm.
  • test sensor packaging container of Alternative Embodiment A wherein the housing of the test sensor packaging container is made of a molded polymeric material.
  • test sensor packaging container for use in a sensor instrument for handling a plurality of test sensors, the test sensor packaging container comprising: a housing having a first housing layer and a second housing layer, the first housing layer having a first plurality of test sensor containing regions and a first plurality of desiccant cavities in fluid communication with each of the first plurality of test sensor containing regions, the second housing layer having a second plurality of test sensor containing regions and a second plurality of desiccant cavities in fluid communication with each of the second plurality of test sensor containing regions, each of the first and second plurality of test sensor containing regions having a proximal end and a distal end and being adapted to contain one of the plurality of test sensors, each of the first and second plurality of test sensor containing regions protruding radially outward from the center of the housing, the housing having a top portion and a bottom portion that are generally parallel, each of the plurality of test sensors having a width direction and a thickness direction; a first foil cover adapted to cover the
  • test sensor packaging container of Alternative Embodiment K further comprising a plurality of open regions formed between each of the first and second plurality of sensor containing regions.
  • test sensor packaging container of Alternative Embodiment L wherein the first and second plurality of test sensor containing regions and the plurality of open regions form a generally gear shaped container, the open regions being positioned on the housing to properly position the test sensor packaging container when the test sensor packaging container is in the sensor instrument.
  • test sensor packaging container of Alternative Embodiment K wherein the container has from about fifty (50) to about seventy (70) test sensor containing regions.
  • test sensor packaging container of Alternative Embodiment N wherein the container has about sixty (60) test sensor containing regions.
  • test sensor packaging container of Alternative Embodiment K wherein the housing has a diameter from about 40 mm to about 55 mm.
  • test sensor packaging container of Alternative Embodiment P wherein the housing has a diameter of from about 45 mm to about 50 mm.
  • test sensor packaging container of Alternative Embodiment K wherein the housing has a thickness of from about 2 mm to about 6 mm.
  • test sensor packaging container of Alternative Embodiment K wherein the housing of the test sensor packaging container is made of a molded polymeric material.
  • test sensor packaging container for use in a sensor instrument for handling a plurality of test sensors
  • the test sensor packaging container comprising: a molded polymeric housing having a first housing layer and a second housing layer, the first housing layer having a first plurality of test sensor containing regions and a first plurality of desiccant cavities in fluid communication with each of the first plurality of test sensor containing regions, the second housing layer having a second plurality of test sensor containing regions and a second plurality of desiccant cavities in fluid communication with each of the second plurality of test sensor containing regions, each of the first and second plurality of test sensor containing regions having a proximal end and a distal end and being adapted to contain one of the plurality of test sensors, each of the first and second plurality of test sensor containing regions protruding radially outward from the center of the housing, the housing having a top portion and a bottom portion that are generally parallel, each of the plurality of test sensors having a width direction and a thickness direction; a first foil cover
  • test sensor packaging container of Alternative Embodiment U wherein the housing has from about fifty (50) to about seventy (70) test sensor containing regions.
  • test sensor packaging container of Alternative Embodiment U wherein the housing has about sixty (60) test sensor containing regions.
  • test sensor packaging container of Alternative Embodiment U wherein the housing has a diameter from about 40 mm to about 55 mm.
  • test sensor packaging container of Alternative Embodiment X wherein the housing has a diameter of from about 45 mm to about 50 mm.
  • test sensor packaging container of Alternative Embodiment U wherein the housing has a thickness of from about 2 mm to about 6 mm.
  • test sensor packaging container of Alternative Embodiment Z wherein the housing has a thickness of about 4 mm.

Abstract

A test sensor packaging container for use in a sensor instrument. The container comprises a housing, a first foil cover, and a second foil cover. The housing has first and second housing layers. The first housing layer has a first plurality of test sensor containing regions. The second housing layer has a second plurality of test sensor containing regions. Each of the first and second plurality of test sensor containing regions protrude radially outward from the center of the housing. The housing has a top portion and a bottom portion that are generally parallel. Each of the test sensors has width and thickness directions. The first foil cover is adapted to cover the top portion of the first housing layer. The second foil cover is adapted to cover the bottom portion of the second housing layer.

Description

PACKAGING CONTAINER FOR TEST SENSORS
FIELD OF THE INVENTION
[0001] The present invention relates generally to a packaging container for test sensors and, more particularly, to a circular packaging container for test sensors to be used in conjunction with a liquid sample monitoring device to provide an analyte concentration in a liquid sample.
BACKGROUND OF THE INVENTION
[0002] Individuals who have irregular blood glucose concentration levels are often medically required to self-monitor their blood glucose concentration level. An irregular blood glucose level can be brought on by a variety of reasons, including illness, such as diabetes. The purpose of monitoring the blood glucose level is to determine the concentration level and then to take corrective action, based on whether the level is too high or too low, to bring the level back within a normal range. The failure to take corrective action may have serious adverse effects on the individual.
[0003] Beyond the above-described blood glucose concentration level monitoring, self- testing systems are used for determining the presence or concentration of other analytes in body fluids, such as, for example, cholesterol, alcohol, and hemoglobin in blood, interstitial fluid, or chemical substances in saliva.
[0004] One method of monitoring a person's blood glucose level is with a portable, handheld, blood glucose testing device. The portable nature of these devices enables users to conveniently test their blood glucose levels wherever the users may be. The test device receives a test sensor for harvesting the blood for analysis. The test sensor, one of which is required for each test, contains a reaction area including a reagent for producing a measurable reaction with the glucose indicative of the blood glucose concentration level. The test sensor harvests the blood for reaction with the reagent stored within.
[0005] Prior art test devices exist that contain a plurality of test sensors or test strips in either a circular sensor packaging container or a cartridge sensor packaging container. An exemplary prior art circular sensor packaging container is disclosed in U.S. Patent No. 5,575,403. In the prior art devices, a plane parallel to the width of the test sensor is parallel to a plane running through the top portion of the housing of the sensor packaging container [0006] One drawback with prior art circular sensor packaging container is the limited number of test sensors contained in the container. The number of test sensors contained in the sensor packaging container is limited by the physical space available for the sensor packaging container within the handheld test device. Therefore, a need exists for a circular sensor packaging container that contains a greater number of test sensors without needing to dramatically increase the physical space taken up within the handheld test device by the circular sensor packaging container.
SUMMARY OF THE INVENTION
[0007] According to one embodiment of the present invention, a test sensor packaging container for use in sensor instrument is provided. The test sensor packaging container comprises a housing, a first foil cover, and a second foil cover. The housing has a first housing layer and a second housing layer. The first housing layer has a first plurality of test sensor containing regions. Each of the first plurality of test sensor containing regions protrude radially outward from the center of the housing. The second housing layer has a second plurality of test sensor containing regions. Each of the second plurality of test sensor containing regions protrude radially outward from the center of the housing. The housing has a top portion and a bottom portion that are generally parallel. Each of the test sensors has a width direction and a thickness direction. The first foil cover is adapted to cover the top portion of the first housing layer of the housing. The second foil cover is adapted to cover the bottom portion of the second housing layer.
[0008] According to another embodiment of the present invention, a test sensor packaging container for use in sensor instrument is provided. The test sensor packaging container comprises a housing, a first foil cover, and a second foil cover. The housing has a first housing layer and a second housing layer. The first housing layer has a first plurality of test sensor containing regions and a first plurality of desiccant cavities in fluid communication with each of the first plurality of test sensor containing regions. The second housing layer has a second plurality of test sensor containing regions and a second plurality of desiccant cavities in fluid communication with each of the second plurality of test sensor containing regions. Each of the first and second plurality of test sensor containing regions has a proximal end and a distal end and is adapted to contain a test sensor. The first and second plurality of test sensor containing regions protrude radially outward from the center of the housing. The housing has a top portion and a bottom portion that are generally parallel. Each of the test sensors has a width direction and a thickness direction. The first foil cover is adapted to cover the top portion of the first housing layer of the housing. The second foil cover is adapted to cover the bottom portion of the second housing layer of the housing. The third foil cover is adapted to cover the distal end of the first plurality of test sensor containing regions. The fourth foil cover is adapted to cover the distal end of the second plurality of test sensor containing regions. A plane generally parallel to the width direction of each of the plurality of test sensors is generally perpendicular to the top and bottom portion of the housing.
[0009] According to a further embodiment of the present invention, a test sensor packaging container for use in sensor instrument is provided. The test sensor packaging container comprises a molded polymeric housing, a first foil cover, and a second foil cover. The housing has a first housing layer and a second housing layer. The first housing layer has a first plurality of test sensor containing regions and a first plurality of desiccant cavities in fluid communication with each of the first plurality of test sensor containing regions. The second housing layer has a second plurality of test sensor containing regions and a second plurality of desiccant cavities in fluid communication with each of the second plurality of test sensor containing regions. Each of the first and second plurality of test sensor containing regions has a proximal end and a distal end and. is adapted to contain a test sensor. The first and second plurality of test sensor containing regions protrude radially outward from the center of the housing. The housing has a top portion and a bottom portion that are generally parallel. Each of the test sensors has a width direction and a thickness direction. The first foil cover is adapted to cover the top portion of the first housing layer of the housing. The second foil cover is adapted to cover the bottom portion of the second housing layer of the housing. The third foil cover is adapted to cover the distal end of the first plurality of test sensor containing regions. The fourth foil cover is adapted to cover the distal end of the second plurality of test sensor containing regions. A plane generally parallel to the width direction of each of the plurality of test sensors is generally perpendicular to the top and bottom portion of the housing.
[0010] The above summary of the present invention is not intended to represent each embodiment or every aspect of the present invention. The detailed description and Figures will describe many of the embodiments of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a top view of a circular sensor packaging container according to one embodiment of the present invention.
[0012] FIG. 2 is a side view of the circular sensor packaging container of FIG. 1.
[0013] FIG. 3 is a top view of a circular sensor packaging container according to another embodiment of the present invention.
[0014] FIG. 4 is a side view of the circular sensor packaging container of FIG. 3.
[0015] FIGS. 5a-c show a partial cross-sectional view of a test sensor being dispensed from the circular sensor packaging container of FIG. 3 according to one embodiment of the present invention.
[0016] FIGS. 6a-b show a partial cross-sectional view of a test sensor being dispensed from the circular sensor packaging container of FIG. 3 according to another embodiment of the present invention.
[0017] FIG. 7 is a top view of a circular sensor packaging container according to a further embodiment of the present invention.
[0018] FIG. 8 is a side view of the circular sensor packaging container of FIG. 7.
[0019] FIG. 9 is a top view of a circular sensor packaging container according to yet another embodiment of the present invention.
[0020] FIG. 10 is a side view of the circular sensor packaging container of FIG. 9.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENT
[0021] Referring now to the drawings, and initially to FIGs. 1 and 2, a circular sensor packaging container 10 for holding a plurality of test sensors 12 used in determining a user's analyte concentration level in a fluid sample is shown according to one embodiment of the present invention. While the following discussion describes the use of test sensors for determining the glucose concentration in blood, it is understood that the present invention maybe employed in determining the concentration of other analytes in other types of samples. Analytes that may be measured using the present invention include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin A1 c, fructose, lactate, or bilirubin. The present invention is not limited, however, to these specific analytes and it is contemplated that other analyte concentrations may be determined. The analytes may be in, for example, a whole blood sample, a blood serum sample, a blood plasma sample, or other body fluids like ISF (interstitial fluid) and urine.
[0022] The sensor packaging container 10 comprises a housing 14 having a first housing layer 16 and a second housing layer 18. The first housing layer 16 having a plurality of first test sensor containing regions 20. The second housing layer 18 having a plurality of second test sensor containing regions 22. Each of the plurality of first and second test sensor containing regions 20, 22 contain a single test sensor 12. The housing 14 has a first foil cover 24 that is adapted to cover the first housing layer 16 of the packaging container 10, sealing each of the plurality of test sensors 12 within the plurality of first test sensor containing regions 20 of the container 10. Additionally, the housing 14 has a second foil cover 26 that is adapted to cover the second housing layer 18 of the packaging container 10, sealing each of the plurality of test sensors 12 within the plurality of second test sensor containing regions 22 of the container 10. The housing 14 and the first and second foil covers 24, 26 completely seal the test sensor 12 from environment. The test sensor 12 has an angled face 13 for piercing the respective foil covers 24, 26 covering the first or second test sensor containing region 20, 22 of the container 10.
[0023] A plurality of first desiccant cavities 28 is in fluid communication with each of the corresponding first sensor containing regions 20. Additionally, a plurality of second desiccant cavities 30 are in fluid communication with ach of the corresponding second sensor containing regions 22. Desiccant material is disposed in the desiccant cavities 28, 30 in order to ensure that the sensor containing regions 20, 22 are maintained at an appropriate humidity level so that the reagent material in the test sensor 12 disposed in the particular sensor containing regions 20, 22 is not adversely affected prior to being used. The desiccant material might be in the form of a small bag or a bead of material or any other form that can be readily disposed in the plurality of desiccant cavities 28, 30. The first desiccant cavities 28 are each in fluid communication with only a single first sensor containing region 20. As a result, the opening of one of the first sensor containing regions 20 will not affect the desiccated state of any of the other first sensor containing regions 20. Similarly, second desiccant cavities 30 are each in fluid communication with only a single second sensor containing region 22. As a result, the opening of one of the second sensor containing regions 22 will not affect the desiccated state of any of the other second sensor containing regions 22. [0024] As is shown in FIG. 2, the test sensor 12 is positioned within the plurality of sensor containing regions 16 of the packaging container 10 such that a plane generally parallel to the width of the test sensor 12 is also generally parallel to the plane of the first and second foil covers 24, 26. By having the first housing layer 16 and the second housing layer 18 the number of test sensors 12 held by the packaging container 10 increases. Increasing the number of test sensors 12 held by the packaging container 10 increases user satisfaction by increasing the number of sample tests that may be performed between changing test sensor packaging containers. The test sensor packaging container 10 is adapted to contain from about fifteen (15) to about twenty five (25) test sensors 12. More specifically, the test sensor packaging container 10 is adapted to contain about twenty (20) test sensors 12. The test sensor packaging container 10 has a diameter D. The diameter D may range from about 40 mm to about 60 mm. More specifically, the diameter D may range from about 50 mm to about 55 mm. The test sensor packaging container 10 has a thickness T. The thickness T of the packaging container 10 may range from about 2 mm to about 8 mm. More specifically, the thickness T of the test sensor packaging container is about 4 mm.
[0025] Turning now to FIGs. 3 and 4, a circular sensor packaging container 110 for holding a plurality of test sensors 12 used in determining a user's analyte concentration level in a fluid sample is shown according to another embodiment of the present invention. The sensor packaging container 110 comprises a housing 114 having a first housing layer 116 and a second housing layer 118. The first housing layer 114 has a plurality of first test sensor containing regions 120. The second housing layer 118 has a plurality of second test sensor containing regions 122. Each of the plurality of first and second test sensor containing regions 120, 122 contains a single test sensor 12.
[0026] The plurality of test sensor containing regions 120, 122 protrudes out from the center of the housing 114. An open region 132 is formed between each of the plurality of sensor containing regions 120, 122. The sensor containing regions 120, 122 and the open regions 132 forms a generally gear shaped pattern on the sensor packaging container 110. [0027] The first housing layer 116 has a first foil cover 124 that is adapted to cover the top portion of the first housing layer 116 of the packaging container 110, sealing the test sensor 12 within the container 110. Additionally, the first housing layer 116 has a third foil cover 134 that is adapted to cover a distal end of the plurality of first sensor containing regions 120 of the first housing layer 116, further sealing the test sensor 12 within the packaging container 110. The first housing layer 116 and the first and third foil covers 124, 134 completely seal the test sensor 12 of the first housing layer 116 from environment. [0028] Similarly, the second housing layer 118 has a second foil cover 126 that is adapted to cover the bottom portion of the second housing layer 118 of the packaging container 110, sealing the test sensor 12 within the container 110. Additionally, the second housing layer 118 has a fourth foil cover 136 that is adapted to cover a distal end of the plurality of second sensor containing regions 122 of the second housing layer 118, further sealing the test sensor 12 within the packaging container 110. The second housing layer 118 and the second and fourth foil covers 126, 136 completely seal the test sensor 12 of the second housing layer 118 from environment.
[0029] The test sensor 12 has an angled face 13 for piercing the respective foil covers 134, 136 covering the distal end of the first or second test sensor containing region 120, 122 of the container 110.
[0030] A plurality of first desiccant cavities 128 is in fluid communication with each of the corresponding first sensor containing regions 120. Additionally, a plurality of second desiccant cavities 130 is in fluid communication with ach of the corresponding second sensor containing regions 122. Desiccant material is disposed in the desiccant cavities 128, 130 in order to ensure that the sensor containing regions 120, 122 are maintained at an appropriate humidity level so that the reagent material in the test sensor 12 disposed in the particular sensor containing regions 120, 122 is not adversely affected prior to being used. The desiccant material might be in the form of a small bag or a bead of material or any other form that can be readily disposed in the plurality of desiccant cavities 128, 130. The first desiccant cavities 128 are each in fluid communication with only a single first sensor containing region 120. As a result, the opening of one of the first sensor containing regions 120 will not affect the desiccated state of any of the other first sensor containing regions 120. Similarly, second desiccant cavities 130 are each in fluid communication with only a single second sensor containing region 122. As a result, the opening of one of the second sensor containing regions 122 will not affect the desiccated state of any of the other second sensor containing regions 122.
[0031] Referring to FIG. 3, the housing 114 of the test sensor packaging container 110 comprises a molded polymeric material according to one embodiment of the present invention. Using a molded polymeric material for the housing 114 increases the structural rigidity of the test sensor packaging container 110. The increased structural rigidity of the housing 114 provided by using a molded polymeric material to form the housing 114 allows the open regions 132 located between each of the plurality of sensor containing regions 120, 122 to be used to align the test sensor packaging container 110 within a testing device. [0032] As is shown in FIG. 4, the test sensor 12 is positioned within the plurality of sensor containing regions 120, 122 of the packaging container 110 such that a plane generally parallel to the width of the test sensor 12 is generally perpendicular to the plane of the top portion of the housing 114 of the test sensor packaging container 110. Arranging the test sensor 12 in such a configuration reduces the amount of space along the periphery of the housing 114 required for each test sensor 12 as the test sensors 12 have a width that is greater than their thickness. Therefore, additional test sensors 12 may be placed within the packaging container 110. hi this way the diameter of the test sensor packaging container 110 does not dramatically increase in order to increase the number of test sensors 12 held by the test sensor packaging container 110. Increasing the number of test sensors 12 held by the packaging container 110 increases user satisfaction by increasing the number of sample tests that may be performed between changing test sensor packaging containers. The test sensor packaging container 110 is adapted to contain from about fifty (50) to about seventy (70) test sensors 12. More specifically, the test sensor packaging container is adapted to contain about sixty (60) test sensors 12. The test sensor packaging container 110 has a diameter D'. The diameter D' may range from about 40 mm to about 55 mm. More specifically, the diameter D' may range from about 45 mm to about 50 mm. The test sensor packaging container 110 has a thickness T'. The thickness T' of the packaging container 110 may range from about 2 mm to about 6 mm. More specifically, the thickness T' of the test sensor packaging container is about 4 mm.
[0033] Turning now to FIGs. 5a-c, the dispensing of one of the test sensors 12 of the first housing layer 116 of test sensor packaging container 110 is shown. As seen in FIG. 5 a the test sensor packaging container 110 is shown in conjunction with a knife assembly 160. As shown in FIG. 5a the knife assembly 160 has generally a "T" shape, however, other shapes may be used for knife assembly 160. The knife assembly 160 is positioned above the first foil cover 124 of one of the plurality of first test sensor containing regions 120. The knife assembly 160 is adapted move in the direction of arrow A to puncture the first foil cover 124 of the packaging container 110. As shown in FIG. 5b, the knife assembly 160 is positioned after it punctures the first foil cover 124 and position the knife assembly 160 within one of the first test sensor containing regions 120. FIG. 5c shows the test sensor 12 after it has been dispensed from the first test sensor containing region 120 of the packaging container 110. The knife assembly 160 moves in the direction shown by arrow B in a radial direction towards the distal end of the first test sensor containing region 120 of the packaging container 110. As the knife assembly 160 moves in the direction of arrow B it contact the test sensor 12, forcing the test sensor 12 towards the distal end of the first test sensor containing region 120. The test sensor 12 contains an angled face 13 that contacts the third foil cover 134 of the packaging container 110. The angled face 13 of the test sensor 12 is adapted to puncture the third foil cover 134 of the packaging container 110. As the knife assembly 160 moves, it continues to puncture the first foil cover 124 covering the first test sensor containing region 120 corresponding to the test sensor 12 being dispensed.
[0034] Turning now to FIGs. 6a and 6b, the dispensing of one of the test sensors 12 of the first housing layer 116 of the test sensor packaging container 110 is shown. As seen in FIG. 6a the test sensor packaging container 110 is shown in conjunction with a knife assembly 162. As shown in FIG. 6a the knife assembly 162 is positioned at a proximal end of one of the plurality of first test sensor containing regions 120. The knife assembly 162 is adapted to slide outward in a radial direction, as shown by arrow C, from the proximal end of one of the plurality of first test sensor containing regions 120 towards the distal end of one of the first test sensor containing regions 120. As shown in FIG. 6b, the test sensor 12 is shown after it has been dispensed from one of the first test sensor containing regions 120 of the packaging container 110. The knife assembly 162 moves in the direction of arrow C towards the distal end of one of the first test sensor containing regions 120 of the packaging container 110. As the knife assembly 162 moves, it contact the test sensor 12 forcing the test sensor 12 towards the distal end of the test sensor containing region. The test sensor 12 contains an angled face 13 that contacts the third foil cover 134 of the packaging container 110. The angled face 13 of the test sensor 12 is adapted to puncture the third foil cover 134 of the packaging container 10.
[0035] Turning now to FIGs. 7 and 8, a circular sensor packaging container 710 for holding a plurality of test sensors 12 used in determining a user's analyte concentration level in a fluid sample is shown according to another embodiment of the present invention. [0036] The sensor packaging container 710 comprises a housing 714 having a first housing layer 716 and a second housing layer 718. The first housing layer 716 having a plurality of first test sensor containing regions 720. The second housing layer 718 having a plurality of second test sensor containing regions 722.~ Each of the plurality of first and second test sensor containing regions 720, 722 contain a single test sensor 12. The housing 714 has a first foil cover 724 that is adapted to cover the first housing layer 716 of the packaging container 710, sealing each of the plurality of test sensors 12 within the plurality of first test sensor containing regions 720 of the container 710. Additionally, the housing 714 has a second foil cover 726 that is adapted to cover the second housing layer 718 of the packaging container 710, sealing each of the plurality of test sensors 12 within the plurality of second test sensor containing regions 722 of the container 710. The housing 714 and the first and second foil covers 724, 726 completely seal the test sensor 12 from environment. The test sensor 12 has an angled face 13 for piercing the respective foil covers 724, 726 covering the first or second test sensor containing region 720, 722 of the container 710. [0037] A plurality of first desiccant cavities 728 is in fluid communication with each of the corresponding first sensor containing regions 720. Additionally, a plurality of second desiccant cavities 730 are in fluid communication with ach of the corresponding second sensor containing regions 722. The desiccant cavities 728, 730 are located at the proximal end of the sensor containing regions 720, 722. Desiccant material is disposed in the desiccant cavities 728, 730 in order to ensure that the sensor containing regions 720, 722 are maintained at an appropriate humidity level so that the reagent material in the test sensor 12 disposed in the particular sensor containing regions 720, 722 is not adversely affected prior to being used. The desiccant material might be in the form of a small bag or a bead of material or any other form that can be readily disposed in the plurality of desiccant cavities 728, 730. The first desiccant cavities 728 are each in fluid communication with only a single first sensor containing region 720. As a result, the opening of one of the first sensor containing regions 720 will not affect the desiccated state of any of the other first sensor containing regions 720. Similarly, second desiccant cavities 730 are each in fluid communication with only a single second sensor containing region 722. As a result, the opening of one of the second sensor containing regions 722 will not affect the desiccated state of any of the other second sensor containing regions 722. [0038] As is shown in FIG. 8, the test sensor 12 is positioned within the plurality of sensor containing regions 716 of the packaging container 710 such that a plane generally parallel to the width of the test sensor 712 is also generally parallel to the plane of the first and second foil covers 724, 726. By having the first housing layer 716 and the second housing layer 718 the number of test sensors 12 held by the packaging container 710 increases. Increasing the number of test sensors 12 held by the packaging container 710 increases user satisfaction by increasing the number of sample tests that may be performed between changing test sensor packaging containers. The test sensor packaging container 710 is adapted to contain from about fifteen (15) to about twenty five (25) test sensors 12. More specifically, the test sensor packaging container 710 is adapted to contain about twenty (20) test sensors 12. The test sensor packaging container 710 has a diameter D. The diameter D may range from about 40 mm to about 60 mm. More specifically, the diameter D may range from about 50 mm to about 55 mm. The test sensor packaging container 710 has a thickness T. The thickness T of the packaging container 710 may range from about 2 mm to about 8 mm. More specifically, the thickness T of the test sensor packaging container 710 is about 4 mm.
[0039] Turning now to FIGs. 9 and 10, a circular sensor packaging container 910 for holding a plurality of test sensors 12 used in determining a user's analyte concentration level in a fluid sample is shown according to a further embodiment of the present invention. The sensor packaging container 910 comprises a housing 914 having a first housing layer 916 and a second housing layer 918. The first housing layer 916 has a plurality of first test sensor containing regions 920. The second housing layer 918 has a plurality of second test sensor containing regions 922. Each of the plurality of first and second test sensor containing regions 920, 922 contains a single test sensor 912. The housing 914 has a first foil cover 924 that is adapted to cover the first housing layer 916 of the packaging container 910, sealing each of the plurality of test sensors 12 within the plurality of first test sensor containing regions 920 of the container 910. Additionally, the housing 914 has a second foil cover 926 that is adapted to cover the second housing layer 918 of the packaging container 910, sealing each of the plurality of test sensors 12 within the plurality of second test sensor containing regions 922 of the container 910. The housing 914 and the first and second foil covers 924, 926 completely seal the test sensor 12 from environment. The test sensor 12 has an angled face 13 for piercing the respective foil covers 924, 926 covering the first or second test sensor containing region 920, 922 of the container 910.
[0040] A plurality of first desiccant regions 928 is in fluid communication with each of the corresponding first sensor containing regions 920. Additionally, a plurality of second desiccant regions 930 is in fluid communication with ach of the corresponding second sensor containing regions 922. Desiccant material is disposed in the desiccant regions 928, 930 in order to ensure that the sensor containing regions 920, 922 are maintained at an appropriate humidity level so that the reagent material in the test sensor 12 disposed in the particular sensor containing regions 920, 922 is not adversely affected prior to being used. The desiccant material of the desiccant regions 928,930 is in the form of a hot-melt desiccant. The hot-melt desiccant is molded into the housing 914 of the test sensor packaging container 910. Using a hot-mold desiccant material simplifies the manufacturing of the packaging container 910 by avoiding the need to fill a desiccant cavity with a desiccant material. The hot-melt desiccant also may be formed in a wide variety of shapes, giving greater flexibility in the positioning of the desiccant. The first desiccant regions 928 are each in fluid communication with only a single first sensor containing region 920. As a result, the opening of one of the first sensor containing regions 920 will not affect the desiccated state of any of the other first sensor containing regions 920. Similarly, second desiccant regions 930 are each in fluid communication with only a single second sensor containing region 922. As a result, the opening of one of the second sensor containing regions 922 will not affect the desiccated state of any of the other second sensor containing regions 922. [0041] As is shown in FIG. 10, the test sensor 12 is positioned within the plurality of sensor containing regions 916 of the packaging container 910 such that a plane generally parallel to the width of the test sensor 12 is also generally parallel to the plane of the first and second foil covers 924, 926. By having the first housing layer 916 and the second housing layer 918 the number of test sensors 12 held by the packaging container 910 increases. Increasing the number of test sensors 12 held by the packaging container 910 increases user satisfaction by increasing the number of sample tests that may be performed between changing test sensor packaging containers. The test sensor packaging container 910 is adapted to contain from about fifteen (15) to about twenty five (25) test sensors 12. More specifically, the test sensor packaging container 910 is adapted to contain about twenty (20) test sensors 12. The test sensor packaging container 910 has a diameter D. The diameter D may range from about 40 mm to about 60 mm. More specifically, the diameter D may range from about 50 mm to about 55 mm. The test sensor packaging container 910 has a thickness
T. The thickness T of the packaging container 910 may range from about 2 mm to about 8 mm. More specifically, the thickness T of the test sensor packaging container 910 is about 4 mm.
[0042] ALTERNATIVE EMBODIMENT A
A test sensor packaging container for use in a sensor instrument for handling a plurality of test sensors, the test sensor packaging container comprising: a housing having first housing layer and a second housing layer, the first housing layer having a first plurality of test sensor containing regions, each of the first plurality of test sensor containing regions being adapted to contain one of the plurality of test sensors, each of the first plurality of test sensor containing regions protruding radially outward from the center of the housing, the second housing layer having a second plurality of sensor containing regions, each of the second plurality of test sensor containing regions protruding radially outward from the center of the housing, the housing having a top portion and a bottom portion that are generally parallel, each of the plurality of test sensors having a width direction and a thickness direction; a first foil cover adapted to cover the top portion of the first housing layer of the housing; and a second foil cover adapted to cover the bottom portion of the second housing layer of the housing. [0043] ALTERNATIVE EMBODIMENT B
The test sensor packaging container of Alternative Embodiment A further comprising a plurality of first desiccant cavities in fluid communication with each of the first test sensor containing regions; and a plurality of second desiccant cavities in fluid communication with each of the second sensor containing regions. [0044] ALTERNATIVE EMBODIMENT C
The test sensor packaging container of Alternative Embodiment B further having desiccant material in each of the plurality of first and second desiccant cavities such that each of the test sensor containing regions is maintained in a desiccate state. [0045] ALTERNATIVE EMBODIMENT D
The test sensor packaging container of Alternative Embodiment A wherein the housing has from about fifteen (15) to about twenty five (25) test sensor containing regions. [0046] ALTERNATIVE EMBODIMENT E
The test sensor packaging container of Alternative Embodiment D wherein the housing has about twenty (20) test sensor containing regions. [0047] ALTERNATIVE EMBODIMENT F
The test sensor packaging container of Alternative Embodiment A wherein the housing has a diameter from about 40 mm to about 60 mm. [0048] ALTERNATIVE EMBODIMENT G
The test sensor packaging container of Alternative Embodiment F wherein the housing has a diameter of from about 50 mm to about 55 mm. [0049] ALTERNATIVE EMBODIMENT H
The test sensor packaging container of Alternative Embodiment A wherein the housing has a thickness of from about 2 mm to about 8 mm. [0050] ALTERNATIVE EMBODIMENT I
The test sensor packaging container of Alternative Embodiment H wherein the housing has a thickness of about 4 mm. [0051] ALTERNATIVE EMBODIMENT J
The test sensor packaging container of Alternative Embodiment A wherein the housing of the test sensor packaging container is made of a molded polymeric material. [0052] ALTERNATIVE EMBODIMENT K
A test sensor packaging container for use in a sensor instrument for handling a plurality of test sensors, the test sensor packaging container comprising: a housing having a first housing layer and a second housing layer, the first housing layer having a first plurality of test sensor containing regions and a first plurality of desiccant cavities in fluid communication with each of the first plurality of test sensor containing regions, the second housing layer having a second plurality of test sensor containing regions and a second plurality of desiccant cavities in fluid communication with each of the second plurality of test sensor containing regions, each of the first and second plurality of test sensor containing regions having a proximal end and a distal end and being adapted to contain one of the plurality of test sensors, each of the first and second plurality of test sensor containing regions protruding radially outward from the center of the housing, the housing having a top portion and a bottom portion that are generally parallel, each of the plurality of test sensors having a width direction and a thickness direction; a first foil cover adapted to cover the top portion of the first housing layer of the housing; a second foil cover adapted to cover the bottom portion of the second housing layer of the housing; a third foil cover adapted to cover the distal end of the first plurality of test sensor containing regions; and a fourth foil cover adapted to cover the distal end of the second plurality of test sensor containing regions, wherein a plane generally parallel to the width direction of each of the plurality of test sensors is generally perpendicular to the top and bottom portion of the housing. [0053] ALTERNATIVE EMBODIMENT L
The test sensor packaging container of Alternative Embodiment K further comprising a plurality of open regions formed between each of the first and second plurality of sensor containing regions. [0054] ALTERNATIVE EMBODIMENT M
The test sensor packaging container of Alternative Embodiment L wherein the first and second plurality of test sensor containing regions and the plurality of open regions form a generally gear shaped container, the open regions being positioned on the housing to properly position the test sensor packaging container when the test sensor packaging container is in the sensor instrument. [0055] ALTERNATIVE EMBODIMENT N
The test sensor packaging container of Alternative Embodiment K wherein the container has from about fifty (50) to about seventy (70) test sensor containing regions. [0056] ALTERNATIVE EMBODIMENT O
The test sensor packaging container of Alternative Embodiment N wherein the container has about sixty (60) test sensor containing regions. [0057] ALTERNATIVE EMBODIMENT P
The test sensor packaging container of Alternative Embodiment K wherein the housing has a diameter from about 40 mm to about 55 mm. [0058] ALTERNATIVE EMBODIMENT O
The test sensor packaging container of Alternative Embodiment P wherein the housing has a diameter of from about 45 mm to about 50 mm. [0059] ALTERNATIVE EMBODIMENT R
The test sensor packaging container of Alternative Embodiment K wherein the housing has a thickness of from about 2 mm to about 6 mm. [0060] ALTERNATIVE EMBODIMENT S
The test sensor packaging container of Alternative Embodiment R wherein the housing has a thickness of about 4 mm. [0061] ALTERNATIVE EMBODIMENT T
The test sensor packaging container of Alternative Embodiment K wherein the housing of the test sensor packaging container is made of a molded polymeric material. [0062] ALTERNATIVE EMBODIMENT U
A test sensor packaging container for use in a sensor instrument for handling a plurality of test sensors, the test sensor packaging container comprising: a molded polymeric housing having a first housing layer and a second housing layer, the first housing layer having a first plurality of test sensor containing regions and a first plurality of desiccant cavities in fluid communication with each of the first plurality of test sensor containing regions, the second housing layer having a second plurality of test sensor containing regions and a second plurality of desiccant cavities in fluid communication with each of the second plurality of test sensor containing regions, each of the first and second plurality of test sensor containing regions having a proximal end and a distal end and being adapted to contain one of the plurality of test sensors, each of the first and second plurality of test sensor containing regions protruding radially outward from the center of the housing, the housing having a top portion and a bottom portion that are generally parallel, each of the plurality of test sensors having a width direction and a thickness direction; a first foil cover adapted to cover the top portion of the first housing layer of the housing; a second foil cover adapted to cover the bottom portion of the second housing layer of the housing; a third foil cover adapted to cover the distal end of the first plurality of test sensor containing regions; and a fourth foil cover adapted to cover the distal end of the second plurality of test sensor containing regions, wherein a plane generally parallel to the width direction of each of the plurality of test sensors is generally perpendicular to the top and bottom portion of the housing. [0063] ALTERNATIVE EMBODIMENT V
The test sensor packaging container of Alternative Embodiment U wherein the housing has from about fifty (50) to about seventy (70) test sensor containing regions. [0064] ALTERNATIVE EMBODIMENT W
The test sensor packaging container of Alternative Embodiment U wherein the housing has about sixty (60) test sensor containing regions. [0065] ALTERNATIVE EMBODIMENT X
The test sensor packaging container of Alternative Embodiment U wherein the housing has a diameter from about 40 mm to about 55 mm. [0066] ALTERNATIVE EMBODIMENT Y
The test sensor packaging container of Alternative Embodiment X wherein the housing has a diameter of from about 45 mm to about 50 mm. [0067] ALTERNATIVE EMBODIMENT Z
The test sensor packaging container of Alternative Embodiment U wherein the housing has a thickness of from about 2 mm to about 6 mm. [0068] ALTERNATIVE EMBODIMENT AA
The test sensor packaging container of Alternative Embodiment Z wherein the housing has a thickness of about 4 mm.
[0069] While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined in the appended claims.

Claims

CLAIMS:
1. A test sensor packaging container for use in a sensor instrument for handling a plurality of test sensors, the test sensor packaging container comprising: a housing having first housing layer and a second housing layer, the first housing layer having a first plurality of test sensor containing regions, each of the first plurality of test sensor containing regions being adapted to contain one of the plurality of test sensors, each of the first plurality of test sensor containing regions protruding radially outward from the center of the housing, the second housing layer having a second plurality of sensor containing regions, each of the second plurality of test sensor containing regions protruding radially outward from the center of the housing, the housing having a top portion and a bottom portion that are generally parallel, each of the plurality of test sensors having a width direction and a thickness direction; a first foil cover adapted to cover the top portion of the first housing layer of the housing; and a second foil cover adapted to cover the bottom portion of the second housing layer of the housing.
2. The test sensor packaging container of claim 1, further comprising a plurality of first desiccant cavities in fluid communication with each of the first test sensor containing regions; and a plurality of second desiccant cavities in fluid communication with each of the second sensor containing regions.
3. The test sensor packaging container of claim 2, further having desiccant material in each of the plurality of first and second desiccant cavities such that each of the test sensor containing regions is maintained in a desiccate state.
4. The test sensor packaging container of claim 1, wherein the housing has from about fifteen (15) to about twenty five (25) test sensor containing regions.
5. The test sensor packaging container of claim 4, wherein the housing has about twenty (20) test sensor containing regions.
6. The test sensor packaging container of claim 1, wherein the housing has a diameter from about 40 mm to about 60 mm.
7. The test sensor packaging container of claim 6, wherein the housing has a diameter of from about 50 mm to about 55 mm.
8. The test sensor packaging container of claim 1, wherein the housing has a thickness of from about 2 mm to about 8 mm.
9. The test sensor packaging container of claim 8, wherein the housing has a thickness of about 4 mm.
10. The test sensor packaging container of claim 1, wherein the housing of the test sensor packaging container is made of a molded polymeric material.
11. A test sensor packaging container for use in a sensor instrument for handling a plurality of test sensors, the test sensor packaging container comprising: a housing having a first housing layer and a second housing layer, the first housing layer having a first plurality of test sensor containing regions and a first plurality of desiccant cavities in fluid communication with each of the first plurality of test sensor containing regions, the second housing layer having a second plurality of test sensor containing regions and a second plurality of desiccant cavities in fluid communication with each of the second plurality of test sensor containing regions, each of the first and second plurality of test sensor containing regions having a proximal end and a distal end and being adapted to contain one of the plurality of test sensors, each of the first and second plurality of test sensor containing regions protruding radially outward from the center of the housing, the housing having a top portion and a bottom portion that are generally parallel, each of the plurality of test sensors having a width direction and a thickness direction; a first foil cover adapted to cover the top portion of the first housing layer of the housing; a second foil cover adapted to cover the bottom portion of the second housing layer of the housing; a third foil cover adapted to cover the distal end of the first plurality of test sensor containing regions; and a fourth foil cover adapted to cover the distal end of the second plurality of test sensor containing regions, wherein a plane generally parallel to the width direction of each of the plurality of test sensors is generally perpendicular to the top and bottom portion of the housing.
12. The test sensor packaging container of claim 11, further comprising a plurality of open regions formed between each of the first and second plurality of sensor containing regions.
13. The test sensor packaging container of claim 12, wherein the first and second plurality of test sensor containing regions and the plurality of open regions form a generally gear shaped container, the open regions being positioned on the housing to properly position the test sensor packaging container when the test sensor packaging container is in the sensor instrument.
14. The test sensor packaging container of claim 11, wherein the container has from about fifty (50) to about seventy (70) test sensor containing regions.
15. The test sensor packaging container of claim 14, wherein the container has about sixty (60) test sensor containing regions.
16. The test sensor packaging container of claim 11, wherein the housing has a diameter from about 40 mm to about 55 mm.
17. The test sensor packaging container of claim 16, wherein the housing has a diameter of from about 45 mm to about 50 mm.
18. The test sensor packaging container of claim 11, wherein the housing has a thickness of from about 2 mm to about 6 mm.
19. The test sensor packaging container of claim 18, wherein the housing has a thickness of about 4 mm.
20. The test sensor packaging container of claim 11, wherein the housing of the test sensor packaging container is made of a molded polymeric material.
21. A test sensor packaging container for use in a sensor instrument for handling a plurality of test sensors, the test sensor packaging container comprising: a molded polymeric housing having a first housing layer and a second housing layer, the first housing layer having a first plurality of test sensor containing regions and a first plurality of desiccant cavities in fluid communication with each of the first plurality of test sensor containing regions, the second housing layer having a second plurality of test sensor containing regions and a second plurality of desiccant cavities in fluid communication with each of the second plurality of test sensor containing regions, each of the first and second plurality of test sensor containing regions having a proximal end and a distal end and being adapted to contain one of the plurality of test sensors, each of the first and second plurality of test sensor containing regions protruding radially outward from the center of the housing, the housing having a top portion and a bottom portion that are generally parallel, each of the plurality of test sensors having a width direction and a thickness direction; a first foil cover adapted to cover the top portion of the first housing layer of the housing; a second foil cover adapted to cover the bottom portion of the second housing layer of the housing; a third foil cover adapted to cover the distal end of the first plurality of test sensor containing regions; and a fourth foil cover adapted to cover the distal end of the second plurality of test sensor containing regions, wherein a plane generally parallel to the width direction of each of the plurality of test sensors is generally perpendicular to the top and bottom portion of the housing.
22. The test sensor packaging container of claim 21, wherein the housing has from about fifty (50) to about seventy (70) test sensor containing regions.
23. The test sensor packaging container of claim 22, wherein the housing has about sixty (60) test sensor containing regions.
24. The test sensor packaging container of claim 21, wherein the housing has a diameter from about 40 mm to about 55 mm.
25. The test sensor packaging container of claim 24, wherein the housing has a diameter of from about 45 mm to about 50 mm.
26. The test sensor packaging container of claim 21, wherein the housing has a thickness of from about 2 mm to about 6 mm.
27. The test sensor packaging container of claim 26, wherein the housing has a thickness of about 4 mm.
PCT/US2006/010189 2005-03-22 2006-03-21 Packaging container for test sensors WO2006102306A1 (en)

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