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. The 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. Test-sensor cartridges may include features designed to mate with corresponding features of a meter to assist in indexing and/or excising the test sensors located within the cartridges. The cartridges also assist in preventing or inhibiting the sensors from being exposed to the environment until they are required for use. During testing, a blood or body fluid sample may be placed on the sensor and analyzed with the meter or instrument to determine the concentration of the analyte being examined.
Because different types of test sensors or test sensor versions may have significant differences associated therewith, a problem occurs when a test sensor is used with a meter that was not designed to be used with the test sensor. This may occur, for example, when a user places a test-sensor cartridge into a meter that is not compatible with the test sensors located within the test-sensor cartridge. Different types of test sensors may include different types of sensor reagent, which may influence items such as the amount of fluid sample needed and the length of time needed to react with the analyte to determine the analyte concentration. Furthermore, different test sensors may correspond with different assay protocols or programs including test sequences, test times, algorithms, voltage, calibration information, or the like.
It may be difficult for a user to determine when a test-sensor cartridge is compatible with a given meter. This difficulty is amplified by the fact that many cartridges are of a generally universal size and configuration and, thus, fit into various types and/or generations of meters. Moreover, meters are generally designed to perform protocols and run programs associated with certain test sensors. Thus, mismatching test-sensor cartridges and meters generally yields inaccurate test results and may result in extra testing, which may be inconvenient and expensive for a user.
It would be desirable to provide test-sensor packaging for limiting the interchangeability of test sensors with different types and/or generations of sensor-dispensing instruments.
USPTO Backgrounds
USPTO Backgrounds