The present invention relates generally to test sensors for use in determining an analyte in a fluid sample and, more particularly, to a cartridge for containing and dispensing a plurality of test sensors.
It is often necessary to quickly obtain a fluid sample (e.g., blood) and to determine an analyte concentration (e.g., glucose) of the sample. One example of a need for obtaining a blood sample is in connection with a blood-glucose monitoring system, which a user must frequently use to monitor the user's blood glucose level. Because users must frequently self-test, manufacturers of blood-glucose monitoring systems are continually striving to simplify the testing process for the user.
One method of obtaining a blood sample and analyzing the sample for determining the glucose level is with a lancing device and a blood-collection device. In obtaining a blood sample, a drop of blood is obtained from, for example, the fingertip using the lancing device, and the blood is harvested using a test sensor. The blood is then analyzed by an instrument or meter to determine the glucose concentration in the blood by using an electrochemical- or optical-based analysis. Electrochemical-based test sensors include a reagent designed to react with glucose in the blood to create an oxidation current at electrodes disposed within the electrochemical biosensor that is directly proportional to the user's blood-glucose concentration. Optional-based test sensors incorporate a reagent designed to produce a colorimetric reaction indicative of a user's blood-glucose concentration level, which is then read by a spectrometer incorporated in the instrument.
These test sensors may be stored in cartridges that dispense the test sensors one at a time. One disadvantage of such cartridges is the ability of a user to determine how many test sensors remain in the cartridge. It would be desirable to have a cartridge that is easy for the user to use, while still being able to determine the number of test sensors remaining.
According to one embodiment, a cartridge comprises a plurality of test sensors, a housing and a window. The plurality of test sensors is adapted to be used in determining the concentration of an analyte of a fluid sample. The plurality of test sensors is in a stacked position. The housing includes an interior, at one least wall and a sensor-discharge opening. The housing is adapted to contain the plurality of test sensors within the interior of the housing. The window is disposed within the at least one wall of the housing. The window permits a user of the cartridge to visually determine the number of test sensors remaining within the interior of the housing. The cartridge is adapted to dispense the plurality of test sensors one at a time from the sensor-dispensing opening.
According to another embodiment, a cartridge comprises a plurality of test sensors, a housing and a window. The plurality of test sensors is adapted to be used in determining the concentration of an analyte of a fluid sample. The plurality of test sensors is in a stacked position. Each of the plurality of test sensors includes a fluid receiving-area. The fluid-receiving area includes reagent. The housing includes an interior, at least one wall, and a sensor-discharge opening. The housing is adapted to contain the plurality of test sensors within the interior of the housing. The window is disposed within the at least one wall of the housing and is located to minimize the exposure of the reagent. The window permits a user of the cartridge to visually determine the number of test sensors remaining within the interior of the housing. The cartridge is adapted to dispense the plurality of test sensors one at a time.
According to one method, a cartridge is provided that contains a plurality of test sensors, a housing and a window. The plurality of test sensors is adapted to be used in determining the analyte of a fluid sample. The plurality of test sensors is in a stacked position. The housing includes an interior, at one least wall and a sensor-discharge opening. The housing is adapted to contain the plurality of test sensors within the interior of the housing. The window is disposed within the at least one wall of the housing. The number of test sensors remaining within the interior of the housing is visually determined via the window.
a is a side view of a test-sensor cartridge with portions thereof removed to show the cartridge interior according to one embodiment of the present invention.
b is a test sensor including a lid according to one embodiments.
c is the test sensor of
a is a side view of a test-sensor cartridge with a seal in a closed position according to one embodiment of the present invention.
b is a side view of the test-sensor cartridge of
While the invention is susceptible to various modifications and alternative forms, specific embodiments are shown by way of example in the drawings and are 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.
Turning to the drawings, and initially to
Generally, a test sensor 12 is dispensed from the cartridge 10, one at a time, on an as-needed basis for use in determining an analyte concentration of a sample. The plurality of test sensors 12 may be electrochemical- or optical-based.
According to one embodiment, one of the test sensors 12 is depicted in
The plurality of test sensors 12 is used in determining the analyte concentration in a fluid sample. For example, glucose in a whole blood sample may be determined. In other embodiments, the plurality of test sensors 12 may be used for determining the concentration or presence of other analytes. Some analytes include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin A1C, fructose, lactate, or bilirubin. The present invention is not limited, however, to determining 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 cartridge 10 comprises a housing 30 in which the plurality of test sensors 12 is stacked on a platform 32 therein. The platform 32 is upwardly biased (as viewed in the direction of arrow A in
To dispense a test sensor 12 from the cartridge 10, a plunger 42 is depressed according to one embodiment. The plunger 42 forces the uppermost test sensor 12a toward the opening 40 as shown in
In alternative embodiments of the present invention, other mechanisms may be used for dispensing the test sensors 12 from the cartridge 10. For example, a slide mechanism disposed along the top of the cartridge, when advanced, may be used to engage and dispense the uppermost test sensor.
The plurality of test sensors 12 of
While the desiccant material 46 shown in
Referring also to
Referring now to
The window 56 is constructed of a material sufficiently optically clear to permit a user on visual inspection to discern the stack of test sensors 12 disposed within the cartridge 10. The window 56 generally permits the user to quickly determine how many test sensors 12 remain within the cartridge 10. In alternative embodiments of the present invention, the window 56 may be placed on one or more sides of the cartridge 10 to provide a user with even greater visual access in determining the number of remaining test sensors 12.
According to another embodiment, a cartridge 70 of
To limit the exposure of the test sensors 12, and specifically the reagent contained therein, to harmful light, the windows discussed above may be constructed of different materials. For example, the windows may be made of a translucent material, optical clear material, a colored material, or combinations thereof. For example, a window may be constructed of a yellow polymeric material that limits the test sensor's exposure to harmful radiation from high-energy blue light or ultraviolet light. It is contemplated that the windows may be made of polymeric materials such as acrylic or polycarbonate.
The window may include pigments that change color to block higher-energy energy light from reaching and affecting the reagent, if any, in the plurality of test sensors 12. It is desirable for the window to be positioned away from the reagent so as to minimize the exposure of the reagent to harmful light.
In addition to the above-described optical qualities, the windows may be sealed (e.g., hermetically sealed) to the housing to prevent or inhibit the introduction of moisture into the cartridge. Further, the window may be constructed of a material that provides a sufficient barrier to moisture. Such materials include, for example, glass and polymeric materials.
The window may be positioned away from the portion of the test sensors that contains the reagent. For example, referring back to
A cartridge comprising:
a plurality of test sensors being adapted to be used in determining the concentration of an analyte of a fluid sample, the plurality of test sensors being in a stacked position;
a housing including an interior, at one least wall and a sensor-discharge opening, the housing being adapted to contain the plurality of test sensors within the interior of the housing; and
a window being disposed within the at least one wall of the housing, the window permitting a user of the cartridge to visually determine the number of test sensors remaining within the interior of the housing,
wherein the cartridge is adapted to dispense the plurality of test sensors one at a time from the sensor-dispensing opening.
The cartridge of embodiment A wherein the plurality of test sensors is electrochemical test sensors.
The cartridge of embodiment A wherein the housing is sealed so as to inhibit introducing moisture into the interior of the housing.
The cartridge of embodiment C wherein the housing includes a first seal and a second seal that are adapted to move between a closed position and an open position and wherein the open position of the first and second seals allows a test sensor to exit the cartridge.
The cartridge of embodiment A further comprising a desiccant material disposed within the housing.
The cartridge of embodiment A further comprising a numerical scale on the at least one wall, the numerical scale being disposed adjacent to the window.
The cartridge of embodiment F further comprising a platform disposed in the interior of the housing on which the plurality of test sensors is stacked, wherein the position of the platform relative to the numerical scale indicates the number of test sensors remaining within the interior of the housing.
The cartridge of embodiment G wherein the platform is biased to urge the plurality of test sensors stacked thereon in a first direction and wherein a longitudinal axis of the window is generally parallel to the first direction.
The cartridge of embodiment G wherein the platform is a first color and the plurality of test sensors is a second color.
The cartridge of embodiment A wherein the window includes a plurality of strip-count windows.
The cartridge of embodiment J further comprising a platform disposed in the interior of the housing on which the plurality of test sensors is stacked, wherein the platform is biased to urge the plurality of test sensors stacked thereon in a first direction and the plurality of strip-count windows being formed in a second direction that is generally perpendicular to the first direction.
The cartridge of embodiment K wherein the plurality of strip-count windows has at least two different lengths.
The cartridge of embodiment K wherein the heights of the plurality of test sensors are the same as the height of the platform.
The cartridge of embodiment A wherein the window is constructed of a colored material.
The cartridge of embodiment A wherein the window is constructed of a translucent material.
The cartridge of embodiment A wherein the analyte comprises glucose and the fluid sample comprises blood.
A cartridge comprising:
a plurality of test sensors being adapted to be used in determining the concentration of an analyte of a fluid sample, the plurality of test sensors being in a stacked position, each of the plurality of test sensors including a fluid receiving-area, the fluid-receiving area including reagent;
a housing including an interior, at least one wall, and a sensor-discharge opening, the housing being adapted to contain the plurality of test sensors within the interior of the housing; and
a window being disposed within the at least one wall of the housing and being located to minimize the exposure of the reagent, the window permitting a user of the cartridge to visually determine the number of test sensors remaining within the interior of the housing,
wherein the cartridge is adapted to dispense the plurality of test sensors one at a time.
The cartridge of embodiment Q wherein the plurality of test sensors is electrochemical test sensors.
The cartridge of embodiment Q wherein the housing is sealed so as to inhibit introducing moisture into the interior of the housing.
The cartridge of embodiment S wherein the housing includes a first seal and a second seal that are adapted to move between a closed position and an open position and wherein the open position of the first and second seals allows a test sensor to exit the cartridge.
The cartridge of embodiment Q further comprising a desiccant material disposed within the housing.
The cartridge of embodiment Q further comprising a numerical scale on the at least one wall, the numerical scale being disposed adjacent to the window.
The cartridge of embodiment V further comprising a platform disposed in the interior of the housing on which the plurality of test sensors is stacked, wherein the position of the platform relative to the numerical scale indicates the number of test sensors remaining within the interior of the housing.
The cartridge of embodiment W wherein the platform is biased to urge the plurality of test sensors stacked thereon in a first direction and wherein a longitudinal axis of the window is generally parallel to the first direction.
The cartridge of embodiment W wherein the platform is a first color and the plurality of test sensors is a second color.
The cartridge of embodiment Q wherein the window includes a plurality of strip-count windows.
The cartridge of embodiment Z further comprising a platform disposed in the interior of the housing on which the plurality of test sensors is stacked, wherein the platform is biased to urge the plurality of test sensors stacked thereon in a first direction and the plurality of strip-count windows being formed in a second direction that is generally perpendicular to the first direction.
The cartridge of embodiment Z wherein the plurality of strip-count windows has at least two different lengths.
The cartridge of embodiment Z wherein the heights of the plurality of test sensors are the same as the height of the platform.
The cartridge of embodiment Q wherein the window is constructed of a colored material.
The cartridge of embodiment Q wherein the window is constructed of a translucent material.
The cartridge of embodiment Q wherein the analyte comprises glucose and the fluid sample comprises blood.
The cartridge of embodiment Q wherein the window is located opposite of the fluid-receiving area that includes reagent.
The cartridge of embodiment Q wherein the window is offset from the fluid-receiving area that includes reagent.
A method of using a cartridge comprising the acts of:
providing a cartridge containing a plurality of test sensors, a housing and a window, the plurality of test sensors being adapted to be used in determining the analyte of a fluid sample, the plurality of test sensors being in a stacked position, the housing including an interior, at one least wall and a sensor-discharge opening, the housing being adapted to contain the plurality of test sensors within the interior of the housing, the window being disposed within the at least one wall of the housing; and
visually determining the number of test sensors remaining within the interior of the housing via the window.
The method of embodiment II further comprising dispensing one of the plurality of test sensors from the cartridge via the sensor-discharge opening.
The method of embodiment II wherein determining includes comparing the viewed test sensors to a numerical scale disposed on the cartridge.
The method of embodiment II wherein each of the plurality of test sensors includes a fluid receiving-area, the fluid-receiving area including reagent and wherein the window is located to minimize the exposure of the reagent.
The method of embodiment LL wherein the window is located opposite of the fluid-receiving area that includes reagent.
The method of embodiment LL wherein the window is offset from the fluid-receiving area that includes reagent.
The method of embodiment II wherein the cartridge further comprises a numerical scale on the at least one wall, the numerical scale being disposed adjacent to the window.
The method of embodiment OO wherein the cartridge further comprises a platform disposed in the interior of the housing on which the plurality of test sensors is stacked, wherein the position of the platform relative to the numerical scale indicates the number of test sensors remaining within the interior of the housing.
The method of embodiment PP wherein the platform is biased to urge the plurality of test sensors stacked thereon in a first direction and wherein a longitudinal axis of the window is generally parallel to the first direction.
The method of embodiment PP wherein the platform is a first color and the plurality of test sensors is a second color.
The method of embodiment II wherein the window includes a plurality of strip-count windows.
The method of embodiment SS wherein the cartridge further comprises a platform disposed in the interior of the housing on which the plurality of test sensors is stacked, wherein the platform is biased to urge the plurality of test sensors stacked thereon in a first direction and the plurality of strip-count windows being formed in a second direction that is generally perpendicular to the first direction.
The method of embodiment TT wherein the plurality of strip-count windows has at least two different lengths.
The method of embodiment II wherein the heights of the plurality of test sensors are the same as the height of the platform.
The method of embodiment II wherein the window is constructed of a colored material.
The method of embodiment II wherein the window is constructed of a translucent material.
The method of embodiment II wherein the analyte comprises glucose and the fluid sample comprises blood.
While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are described in detail herein. It should be understood, however, that it is not intended to limit the invention to the particular forms disclosed, but, to the contrary, the intention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the invention.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US05/37355 | 10/19/2005 | WO | 00 | 4/9/2007 |
Number | Date | Country | |
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60620710 | Oct 2004 | US |