Patent Application
20100099192
The present invention relates generally to analyte-testing instruments and, more particularly, to a test-sensor cartridge having a non-radial test-sensor layout.
The quantitative determination of analytes in body fluids is of great importance in the diagnoses and maintenance of certain physiological abnormalities. For example, lactate, cholesterol, and bilirubin should be monitored in certain individuals. In particular, determining glucose in body fluids is important to diabetic individuals who must frequently check the glucose level in their body fluids to regulate the glucose intake in their diets. The results of such tests may be used to determine what, if any, insulin and/or other medication needs to be administered. In one type of testing system, test sensors are used to test a fluid such as a sample of blood.
One method of monitoring an individual's blood glucose level is with a portable, hand-held blood glucose testing device (e.g., a meter). To determine the blood glucose level with the meter, a lancet device may be used with a needle lancet that pierces the skin tissue and allows a whole blood sample to form on the skin's surface. Once the requisite amount of blood forms on the skin's surface, the blood sample is transferred to a test sensor. The test sensor is generally placed in an opening in the body of the meter.
Test-sensor cartridges are commonly used to individually dispense test sensors to be used for testing an analyte in a fluid. Test-sensor cartridges may be incorporated directly into, for example, glucose meters to dispense test sensors for use with the meter. The cartridges are used to store multiple sensors and allow users to carry multiple sensors around within a single enclosure. The cartridges also assist in preventing or inhibiting the sensors from being exposed to the environment until they are required for use. A blood or body fluid sample may then be placed on the sensor and analyzed with the meter or similar device to determine the concentration of the analyte being examined.
One example of a prior art cartridge 100 is shown in
Each time analyte-testing is performed, a new test sensor is used, and thus, a number of test sensors may be used in a single day. It is desirable for the meter to be generally compact in size so that the meter can be easily transported by a user. Existing meters contain one test-sensor cartridge. This may be undesirable since a user may realize that he or she has used all of the test sensors in the test-sensor cartridge at inopportune times. For example, the user may run out of test sensors while away from home and without having an extra cartridge available thereby likely causing inconvenience to the user.
Furthermore, existing test sensor cartridges include test sensors and test-sensor cavities arranged in a generally radial layout. To maximum the amount of test sensors included within the cartridge, the area between test sensors is often small. Thus, the area between the test sensors may include a thin section made of, for example, plastic or other suitable materials. The thin plastic section may be susceptible to tearing, or moisture may migrate from a cavity from which a sensor has been removed to the next sensor cavity via the thin plastic section. The thin plastic section may also make manufacturing of the cartridges difficult.
It would be desirable to have test-sensor cartridges that assist in addressing one or more of the above disadvantages.
According to one embodiment of the present invention, a test-sensor cartridge comprises a first face, a second opposing face, and a side portion connecting the first and second opposing faces. The first face forms a plurality of test-sensor cavities that is generally uniformly positioned therethrough. The plurality of the test sensor cavities are arranged in a non-radial layout. The plurality of test-sensor cavities contains a respective test sensor. The test sensor is adapted to assist in determining a concentration of an analyte.
According to another embodiment of the present invention, an instrument adapted to determine an analyte concentration of a fluid sample using a test sensor is disclosed. The instrument comprises a display adapted to display information to a user and a user-interface mechanism adapted to allow the user to interact with the instrument. The instrument further comprises a test-sensor cartridge comprising a first face, a second opposing face, and a side portion connecting the first and second opposing faces. The first face forms a plurality of test-sensor cavities that is generally uniformly positioned therethrough. The plurality of the test sensor cavities is arranged in a non-radial layout. The plurality of test-sensor cavities contains a respective test sensor. The test sensor is adapted to assist in determining a concentration of the analyte. The instrument further comprises a body portion including at least a first opening formed therein. The first opening is adapted to receive a test sensor from the test-sensor cartridge.
According to another embodiment of the present invention, a method of excising a test sensor from a test-sensor cartridge located within an analyte-testing instrument is disclosed. The method comprises the act of providing a test-sensor cartridge comprising a first face, a second opposing face, and a side portion connecting the first and second opposing faces. The first face forms a plurality of test-sensor cavities that is generally uniformly positioned therethrough. The plurality of the test sensor cavities are arranged in a non-radial layout. The plurality of test-sensor cavities contain a respective test sensor. The test sensor is adapted to assist in determining a concentration of an analyte. The method further comprises the act of providing an instrument comprising a display adapted to display information to a user, a user-interface mechanism adapted to allow the user to interact with the instrument, a body portion including at least a first opening formed therein, the first opening being adapted to receive a test sensor from the test-sensor cartridge, and an excise mechanism. The method further comprises the act of moving the excise mechanism so as to excise a test sensor from the cartridge, the excised test sensor being positioned within the first opening of the instrument.
The above summary of the present invention is not intended to represent each embodiment or every aspect of the present invention. Additional features and benefits of the present invention are apparent from the detailed description and figures set forth below.
a is a front view of a prior art test-sensor cartridge according to one embodiment.
b is a side perspective view of the prior art test-sensor cartridge of
a is a front view of a test-sensor cartridge according to one embodiment of the present invention.
b is a side perspective view of the test-sensor cartridge of
c is a side perspective view of the test-sensor cartridge of
d is an exploded side view of the test-sensor cartridge of
a is a front view of a test-sensor cartridge according to another embodiment of the present invention.
b is a side perspective view of the test-sensor cartridge of
The present invention is directed to test-sensor cartridges. The test sensors (e.g., biosensors) excised from the cartridge may be used to assist in determining an analyte concentration in a fluid sample. Some examples of the types of analytes that may be collected and analyzed include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL, and HDL), microalbumin, 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/or urine. One non-limiting example of the analyte-testing instruments' use is to determine the glucose concentration in a user's blood, plasma, or ISF.
Turning now to the drawings and initially to
The cartridge 200 of the illustrated embodiment includes ten generally uniformly spaced test-sensor cavities 208, each storing a respective one of ten individual test sensors 206. The test-sensor cavities 208 may be interconnected or separate from one another. It is contemplated that the cartridge 200 may include a different number of test sensors 206 and corresponding test-sensor cavities 208. The test sensors 206 may be electrochemical, optical, colorimetric or the like. The test sensors 206 are sealed within the respective test-sensor cavities 208 to assist in preventing or inhibiting the test sensors 206 from being exposed to the atmosphere and/or moisture. The seal may be made of foil or other metallic materials or polymeric materials.
According to the present invention, the test-sensor cavities 208 and the corresponding test sensors 206 have a generally non-radial layout. To form the non-radial layout, the test-sensor cavities 208 are generally offset from a radial line 2-2 extending through the center of the cartridge 200 and the center of a test-sensor cavity at an angle A ranging from approximately 1.0 degree to approximately 30 degrees. More specifically, the angle A may range from approximately 10 degrees to approximately 20 degrees.
A cartridge having a non-radial layout (e.g., cartridge 200) according to the present invention provides several benefits over a cartridge adapted to store the same amount of test sensors in a radial layout (e.g., cartridge 100 of prior art). For example, the cartridge 200 provides for a greater clearance between each test-sensor cavity 208. Thus, the cartridge 200 has a greater tolerance and is therefore generally more robust and sturdy than, for example, the cartridge 100 having a radial layout. Thus, the area of the cartridge 200 between the test-sensor cavities 208 is less likely to be torn or broken, which may promote ease in manufacturing. Additionally, tears in the area between test-sensor cavities 208 may expose the test sensors 206 within the cavities 208 to potential contaminants and/or moisture in the atmosphere, which may be harmful to a user and/or lead to inaccurate test results. Furthermore, if the area between adjacent test-sensor cavities is too small, moisture may migrate from a cavity from which a sensor has been removed to the next sensor cavity via the small area between the test-sensor cavities.
According to another embodiment of the present invention, the cartridge 200 optionally includes a plurality of generally uniformly-spaced tooth-like notches 212 on an end 213 of the cartridge 200 opposite the face 202 (see
Although in the illustrated embodiments, the face 202 of the cartridge 200 is generally round, it is contemplated that the face 202 may have other shapes including, but not limited to, hexagonal, octagonal, decagonal, or other polygonal shapes. For example,
According to one embodiment; the cartridge of the present invention (e.g., cartridge 200) includes electrochemical test sensors. The test sensors may include an enzyme. For example, if the analyte to be tested is glucose, the test sensors may contain, for example, glucose dehydrogenase or glucose oxidase.
It is contemplated that one or more cartridges of the present invention may be stored within an analyte-testing instrument (e.g., a meter). Turning now to
The cartridge 200 of
Moreover, although the present invention has been described in reference to a compact cartridge, it is contemplated that the non-radial layout of the test sensors shown in
A test-sensor cartridge comprising a first face, a second opposing face, and a side portion connecting the first and second opposing faces, the first face forming a plurality of test-sensor cavities that is generally uniformly positioned therethrough, the plurality of the test sensor cavities being arranged in a non-radial layout, the plurality of test-sensor cavities containing a respective test sensor, the test sensor being adapted to assist in determining a concentration of an analyte.
The cartridge of Alternative Embodiment A, wherein at least the first face is generally round.
The cartridge of Alternative Embodiment B, wherein the second face is generally round.
The cartridge of Alternative Embodiment B, wherein the outer diameter of the face of the cartridge is from about 0.25 inches to about 2.0 inches.
The cartridge of Alternative Embodiment B, wherein the outer diameter of the face of the cartridge is from about 0.50 inches to about 1.5 inches.
The cartridge of Alternative Embodiment A, wherein at least the first face is generally polygonal.
The cartridge of Alternative Embodiment F, wherein the second face is generally polygonal.
The cartridge of Alternative Embodiment A, wherein the second face further comprises a plurality of generally uniformly-spaced notches, the number of notches corresponding to the number of test-sensor cavities.
The cartridge of Alternative Embodiment A wherein the test-sensor cavities are generally offset from a radial position at an angle ranging from approximately 1.0 degree to approximately 30 degrees.
The cartridge of Alternative Embodiment A wherein the test-sensor cavities are generally offset from a radial position at an angle ranging from approximately 10 degrees to approximately 20 degrees.
The cartridge of Alternative Embodiment A, wherein the test sensor is an electrochemical test sensor.
The cartridge of Alternative Embodiment K, wherein the test sensor includes an enzyme.
The cartridge of Alternative Embodiment L, wherein the analyte is glucose.
The cartridge of Alternative Embodiment M, wherein at least the enzyme is glucose dehydrogenase.
The cartridge of Alternative Embodiment M, wherein at least the enzyme is glucose oxidase.
An instrument adapted to determine an analyte concentration of a fluid sample using a test sensor, the instrument comprising:
The instrument of Alternative Embodiment P, wherein at least the first face is generally round.
The instrument of Alternative Embodiment Q, wherein the second face is generally round.
The instrument of Alternative Embodiment Q, wherein the outer diameter of the face of the cartridge is from about 0.25 inches to about 2.0 inches.
The instrument of Alternative Embodiment Q, wherein the outer diameter of the face of the cartridge is from about 0.50 inches to about 1.5 inches.
The instrument of Alternative Embodiment P, wherein at least the first face is generally polygonal.
The instrument of Alternative Embodiment U, wherein the second face is generally polygonal.
The instrument of Alternative Embodiment P, wherein the second face further comprises a plurality of generally uniformly-spaced notches, the number of notches corresponding to the number of test-sensor cavities.
The instrument of Alternative Embodiment P wherein the test-sensor cavities are generally offset from a radial position at an angle ranging from approximately 10 degrees to approximately 30 degrees.
The instrument of Alternative Embodiment P wherein the test-sensor cavities are generally offset from a radial position at an angle ranging from approximately 10 degrees to approximately 20 degrees.
The instrument of Alternative Embodiment P, wherein the test sensor is an electrochemical test sensor.
The instrument of Alternative Embodiment Z, wherein the test sensor includes an enzyme.
The instrument of Alternative Embodiment AA, wherein the analyte is glucose.
The instrument of Alternative Embodiment AB, wherein at least the enzyme is glucose dehydrogenase.
The instrument of Alternative Embodiment AB, wherein at least the enzyme is glucose oxidase.
The instrument of Alternative Embodiment P further comprising a mechanism adapted to index the test sensor from the test-sensor cartridge.
The instrument of Alternative Embodiment P further comprising a mechanism adapted to excise the test sensor from the test-sensor cartridge.
A method of excising a test sensor from a test-sensor cartridge located within an analyte-testing instrument, the method comprising the acts of:
The method of Alternative Process AF, wherein at least the first face is generally round.
The method of Alternative Process AG, wherein the second face is generally round.
The method of Alternative Process AG, wherein the outer diameter of the face of the cartridge is from about 0.25 inches to about 2.0 inches.
The method of Alternative Process AG, wherein the outer diameter of the face of the cartridge is from about 0.50 inches to about 1.5 inches.
The method of Alternative Process AF, wherein at least the first face is generally polygonal.
The method of Alternative Process AK, wherein the second face is generally polygonal.
The method of Alternative process AF, wherein the second face further comprises a plurality of generally uniformly-spaced notches, the number of notches corresponding to the number of test-sensor cavities.
The method of Alternative Process AF wherein the test-sensor cavities are generally offset from a radial position at an angle ranging from approximately 1.0 degrees to approximately 30 degrees.
The method of Alternative Process AF wherein the test-sensor cavities are generally offset from a radial position at an angle ranging from approximately 10 degrees to approximately 20 degrees.
The method of Alternative Process AF, wherein the test sensor is an electrochemical test sensor.
The method of Alternative Process AP, wherein the test sensor includes an enzyme.
The method of Alternative Process AQ, wherein the analyte is glucose.
The method of Alternative Process AR, wherein at least the enzyme is glucose dehydrogenase.
The instrument of Alternative Process AR, wherein at least the enzyme is glucose dehydrogenase.
The method of Alternative Process AF further comprising a mechanism adapted to index the test sensor from the test-sensor cartridge.
While the invention is susceptible to various modifications and alternative forms, specific embodiments and methods 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 or methods disclosed, but, to the contrary, the intention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US07/06272 | 3/12/2007 | WO | 00 | 9/10/2009 |
