The present invention relates generally to test sensors that are adapted to determine an analyte concentration. More specifically, the present invention generally relates to auto-calibrating test sensors.
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, it is important that diabetic individuals 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 or other medication should be administered. In one type of blood-glucose testing system, test sensors are used to test a sample of blood.
A test sensor contains biosensing or reagent material that reacts with, for example, blood glucose. The testing end of the sensor is adapted to be placed into the fluid being tested (e.g., blood) that has accumulated on a person's finger after the finger has been pricked. The fluid may be drawn into a capillary channel that extends in the sensor from the testing end to the reagent material by capillary action so that a sufficient amount of fluid to be tested is drawn into the sensor. The tests are typically performed using optical or electrochemical testing methods.
Diagnostic systems, such as blood-glucose testing systems, typically calculate the actual glucose value based on a measured output and the known reactivity of the reagent-sensing element (e.g., test sensor) used to perform the test. The reactivity or lot-calibration information of the test sensor may be provided on a calibration circuit that is associated with the sensor package or the test sensor. This calibration circuit is typically physically inserted by the end user. In other cases, the calibration is automatically done using an auto-calibration circuit via a label on the sensor package or the test sensor. In this case, calibration is transparent to the end user and does not require that the end user insert a calibration circuit into the meter. Manufacturing millions of sensor packages, each having a calibration circuit or label to assist in calibrating the sensor package, can be expensive.
Therefore, it would be desirable to have a test sensor that provides calibration information thereon that may be manufactured in an efficient and/or cost-effective manner.
According to one process, a method of making a test sensor configured to assist in determining information related to an analyte in a fluid sample is disclosed. The method comprises the act of providing a base having a first end and a second opposing end. The method further comprises the act of providing a fluid-receiving area configured to receive a fluid sample. The method further comprises the act of assigning calibration information to the test sensor. The method further comprises the act of forming at least one notch such that a depth of the notch corresponds to the calibration information.
According to another process, a method of making a test sensor configured to assist in determining information related to an analyte in a fluid sample is disclosed. The method comprises the act of providing a base having a first end and a second opposing end. The method further comprises the act of providing a fluid-receiving area configured to receive a fluid sample. The method further comprises the act of assigning calibration information to the test sensor. The test sensor includes at least one plate thereon such that the size of the at least one plate corresponds to the calibration information. The at least one plate also includes electrically-conductive material.
According to another process, a method of using a test sensor and a meter is disclosed. The test sensor and meter use calibration information in determining information related to an analyte in a fluid sample. The method comprises the act of providing a test sensor including a base having a first end and a second opposing end. The test sensor further includes a fluid-receiving area configured to receive the fluid sample. The test sensor further includes at least one notch formed therein. The method further comprises the act of assigning calibration information to the test sensor. The method further comprises the act of providing a meter with a test-sensor opening. The meter includes a potentiometer positioned at or near the test-sensor opening. The potentiometer includes a movable actuator that receives the at least one notch. The method further comprises the act of placing the test sensor into the test-sensor opening of the meter. The method further comprises the act of moving the test sensor so as to move the movable actuator. The method further comprises the act of determining a measured resistance of the potentiometer. The method further comprises the act of applying the calibration information using the measured resistance to assist in determining the information related to the analyte in the fluid sample.
According to a further process, a method of using a test sensor and a meter is disclosed. The test sensor and meter use calibration information in determining information related to an analyte in a fluid sample. The method comprises the act of providing a test sensor including a base having a first end and a second opposing end. The test sensor further includes a fluid-receiving area configured to receive the fluid sample. The test sensor further includes at least one notch formed therein. The method further comprises the act of assigning calibration information to the test sensor. The method further comprises the act of providing a meter with a test-sensor opening. The meter includes a pseudo potentiometer positioned at or near the test-sensor opening. The pseudo potentiometer includes a plurality of pads. The plurality of pads include resistive materials. The method further comprises the act of placing the test sensor into the test-sensor opening of the meter. The method further comprises the act of moving the test sensor so as to cause at least one of the plurality of pads to receive the at least one notch. The method further comprises the act of determining a measured resistance of the pseudo potentiometer. The method further comprises the act of applying the calibration information using the measured resistance to assist in determining the information related to the analyte in the fluid sample.
According to yet another process, a method of using a test sensor and a meter is disclosed. The test sensor and meter use calibration information in determining information related to an analyte in a fluid sample. The method comprises the act of providing a test sensor including a base having a first end and a second opposing end. The test sensor further includes a fluid-receiving area configured to receive the fluid sample. The test sensor further includes at least one notch formed therein. The method further comprises the act of assigning calibration information to the test sensor. The method further comprises the act of providing a meter with a test-sensor opening. The meter includes a variable inductor positioned at or near the test-sensor opening. The variable inductor includes a movable plunger and at least one wire coil. The moveable plunger is configured to move within the at least one wire coil. The moveable plunger receives the at least one notch. The method further comprises the act of placing the test sensor into the test-sensor opening of the meter. The method further comprises the act of moving the test sensor so as to move the moveable plunger a distance within the at least one wire coil. The method further comprises the act of determining a measured electrical value of the variable inductor. The measured electrical value corresponds to the distance that the moveable plunger is moved within the at least one wire coil. The method further comprises the act of applying the calibration information using the measured electrical value to assist in determining the information related to the analyte in the fluid sample.
According to another process, a method of using a test sensor and a meter is disclosed. The test sensor and meter use calibration information in determining information related to an analyte in a fluid sample. The method comprises the act of providing a test sensor including a base having a first end and a second opposing end. The test sensor further includes a fluid-receiving area configured to receive the fluid sample. The test sensor further includes at least one notch formed therein. The method further comprises the act of assigning calibration information to the test sensor. The method further comprises the act of providing a meter with a test-sensor opening. The meter includes a variable capacitor positioned at or near the test-sensor opening. The variable capacitor includes a movable plunger and a sleeve. The moveable plunger is configured to move within the sleeve. The moveable plunger also receives the at least one notch. The method further comprises the act of placing the test sensor into the test-sensor opening of the meter. The method further comprises the act of moving the test sensor so as to move the moveable plunger a distance within the sleeve. The method further comprises the act of determining a measured capacitance of the variable capacitor. The measured capacitance corresponding to the distance that the moveable plunger is pushed within the sleeve. The method further comprises the act of applying the calibration information using the measured capacitance to assist in determining the information related to the analyte in the fluid sample.
According to another process, a method of using a test sensor and a meter is disclosed. The test sensor and meter use calibration information in determining information related to an analyte in a fluid sample. The method comprises the act of providing a test sensor including a base having a first end and a second opposing end. The test sensor further includes a fluid-receiving area configured to receive the fluid sample. The test sensor further includes at least one sensor plate thereon. The at least one sensor plate is made from electrically-conductive materials. The method further comprises the act of assigning calibration information to the test sensor. The method further comprises the act of providing a meter with a test-sensor opening. The meter includes a meter plate positioned at or near the test-sensor opening. The meter plate is made from electrically-conductive materials. The method further comprises the act of placing the test sensor into the test-sensor opening of the meter. The method further comprises the act of moving the test sensor such that at least a portion of the meter plate overlaps at least a portion of the at least one sensor plate. The method further comprises the act of determining a measured capacitance of the meter plate. The measured capacitance corresponds to the size of the at least one sensor plate. The method further comprises the act of applying the calibration information using the measured capacitance to assist in determining the information related to the analyte in the fluid sample.
According to another process, a method of using a test sensor and a meter is disclosed. The test sensor and meter use calibration information in determining information related to an analyte in a fluid sample. The method comprises the act of providing a test sensor including a base having a first end and a second opposing end. The test sensor further includes a fluid-receiving area configured to receive the fluid sample. The test sensor further includes at least one sense portion. The method further comprises the act of assigning calibration information to the test sensor. The method further comprises the act of providing a meter with a test-sensor opening. The meter includes a parallel plate capacitor positioned at or near the test-sensor opening. The parallel plate capacitor includes two electrically-conductive plates. The parallel plate capacitor is configured to allow the at least one sense portion of the test sensor to be positioned between the two electrically-conductive plates. The method further comprises the act of placing the test sensor into the test-sensor opening of the meter. The method further comprises the act of moving the test sensor such that at least the sense portion of the test sensor is positioned between the two electrically-conductive plates. The method further comprises the act of determining a measured capacitance of the parallel plate capacitor. The method further comprises the act of applying the calibration information using the measured capacitance to assist in determining the information related to the analyte in the fluid sample.
According to another process, a method of using a test sensor and a meter is disclosed. The test sensor and meter use calibration information in determining information related to an analyte in a fluid sample. The method comprises the act of providing a test sensor including a base having a first end and a second opposing end. The test sensor further includes a fluid-receiving area configured to receive the fluid sample. The test sensor further includes at least one notch formed therein. The method further comprises the act of assigning calibration information to the test sensor. The method further comprises the act of providing a meter with a test-sensor opening. The meter includes a piezoelectric element positioned at or near the test-sensor opening. The piezoelectric element receives the at least one notch. The method further comprises the act of placing the test sensor into the test-sensor opening of the meter. The method further comprises the act of moving the test sensor so as to compress the piezoelectric element a distance. The method further comprises the act of determining a measured voltage of the piezoelectric element. The measured voltage corresponds to the distance that the piezoelectric element is compressed. The method further comprises the act of applying the calibration information using the measured voltage to assist in determining the information related to the analyte in the fluid sample.
The above summary 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.
The foregoing and other advantages of the invention will become apparent upon reading the following detailed description and upon reference to the drawings.
a is a test sensor according to one embodiment.
b is a side view of the test sensor 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.
Generally, an instrument or meter uses a test sensor adapted to receive a fluid sample to be analyzed and a processor adapted to perform a predefined test sequence for measuring a predefined parameter value. A memory is coupled to the processor for storing predefined parameter data values. Calibration information associated with the test sensor may be read by the processor before or after the fluid sample to be measured is received, but not after the analyte concentration has been determined. Calibration information is generally used to compensate for different characteristics of test sensors, which will vary on a batch-to-batch basis.
The calibration information may be, for example, the lot specific reagent calibration information for the test sensor. The calibration information may be in the form of a calibration code. Selected information associated with the test sensor (which may vary on a batch-to-batch basis) is tested to determine the calibration information to be used in association with the meter.
The present invention is directed to an improved method of making a test sensor that is adapted to assist in determining an analyte concentration. In one embodiment, a test sensor is adapted to receive a fluid sample. The fluid sample is analyzed using an instrument or meter. Analytes that may be measured include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL, and HDL), microalbumin, hemoglobin AIC, fructose, lactate, or bilirubin. 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, other body fluids like ISF (interstitial fluid), creatinine, urea, urine, and non-body fluids.
The test sensors described herein may be electrochemical test sensors. One non-limiting example of an electrochemical test sensor is shown in
The fluid-receiving area 19 includes at least one reagent for converting the analyte of interest (e.g., glucose) in the fluid sample (e.g., blood) into a chemical species that is electrochemically measurable, in terms of the electrical current it produces, by the components of the electrode pattern. The reagent typically contains an enzyme such as, for example, glucose oxidase, which reacts with the analyte and with an electron acceptor such as a ferricyanide salt to produce an electrochemically measurable species that can be detected by the electrodes. It is contemplated that other enzymes may be used to react with glucose such as glucose dehydrogenase. If the concentration of another analyte is to be determined, an appropriate enzyme is selected to react with the analyte.
A fluid sample (e.g., blood) may be applied to the fluid-receiving area 19. The fluid sample reacts with the at least one reagent. After reacting with the reagent and in conjunction with the plurality of electrodes, the fluid sample produces electrical signals that assist in determining the analyte concentration. The conductive leads 15a,b carry the electrical signal back toward a second opposing end 42 of the test sensor 10 where the test-sensor contacts 14a,b transfer the electrical signals into the meter.
Referring to
To form the test sensor 10 of
It is contemplated that the test sensors of the embodiments of the present invention may be formed with a base and a lid in the absence of a spacer. In one such embodiment, a lid may be formed with a convex opening that is adapted to receive a fluid. A non-limiting example of such a test sensor is shown in
The test sensors of the embodiments described herein may be optical test sensors. Optical test-sensor systems may use techniques such as, for example, transmission spectroscopy, diffuse reflectance, or fluorescence spectroscopy for measuring the analyte concentration. An indicator reagent system and an analyte in a sample of body fluid are reacted to produce a chromatic reaction, as the reaction between the reagent and analyte causes the sample to change color. The degree of color change is indicative of the analyte concentration in the body fluid. The color change of the sample is evaluated to measure the absorbance level of the transmitted light.
Referring back to
According to one embodiment of the present invention, a test-sensor combination may be used with at least one potentiometer to determine calibration information corresponding with a particular test sensor. The potentiometer is generally housed within a meter (e.g., meter 60 of
When the test sensor is inserted through the test-sensor opening, a notch formed in the test sensor contacts the actuator and pushes the actuator, thereby setting the measured resistance. The depth of the notch(es) determines the distance that the actuator moves, which corresponds to the measured resistance. The measured resistance is compared to stored nominal resistances corresponding with particular types of calibration information. Each nominal resistance associated with each different type of test sensor includes an acceptable boundary or deviation. The acceptable boundary is determined based upon the accuracy of the potentiometer. The calibration information having an associated nominal resistance closest to the measured resistance and within the acceptable boundary of the nominal resistance is applied.
The depth of the notch is, thus, varied among test sensors having different calibration information. Test sensors having notches of different depths push the actuator different distances. More specifically, test sensors having notches of greater depths push the actuator shorter distances, and test sensors having notches of smaller depths push the actuator larger distances.
After the test sensors illustrated and described above in
The embodiment of
According to other embodiments of the present invention, a test-sensor combination may be used with a variable inductor to determine calibration information corresponding with a particular test sensor.
When the test sensor 110 is inserted through the test-sensor opening 325, the notch 121 contacts the plunger 323 and pushes the plunger 323 a distance within the wire coil(s) 324, thereby changing the permeability of the core of the variable inductor 320. As the permeability of the core increases, the inductance of the wire coil(s) 324 increases. Likewise, as the permeability of the core decreases, the inductance of the wire coil(s) 324 decreases. Thus, the distance that the plunger 323 is pushed determines the inductance of the wire coil(s) 324. It is contemplated that the wire coil(s) 324 may be positioned within the test-sensor opening 325 such that the plunger 323 is pushed into or out of the wire coil(s) when the test sensor 110 is inserted through the test-sensor opening 325. It is also contemplated that the plunger 323 may be made from materials having high magnetic susceptibility (e.g., ferromagnetic materials) to achieve greater changes in inductance relative to the plunger's 323 position within the wire coil(s) 324.
The inductance may be directly measured by, for example, a frequency counter or an AC bridge. The measured inductance value is compared to stored inductances values corresponding with particular types of calibration information. Each stored inductance value associated with each different type of test sensor 110 includes an acceptable boundary or deviation. The acceptable boundary is based upon the accuracy of the variable inductor system 320. The calibration information having an associated stored inductance value closest to the measured inductance value and within the acceptable boundary of the stored inductance value is applied. It is contemplated that in some embodiments other electrical characteristics directly affected by the inductance of the wire coil(s) including, but not limited to, voltage, current, resonant frequency, reactance, or combinations thereof may be measured and compared.
The depth of the notch 121 is, thus, varied among test sensors 110 having different calibration information. As described above, test sensors having notches of different depths push the plunger 323 different distances. More specifically, test sensors having notches of greater depths push the plunger 323 shorter distances, and test sensors having notches of smaller depths push the plunger 323 larger distances.
In one aspect, a linear variable differential transformer (hereinafter “LVDT”) is formed from the plunger 323 and the wire coil(s) 324. Any suitable additional circuitry necessary to complete the LVDT circuit may be implemented on a microprocessor or a printed circuit board. There are several advantages associated with LVDT configurations. For example, LVDT circuits have minimal, if any, sensitivity to movements of the plunger 323 in any direction other than the direction along the cental axis of the wire coil(s) 324 (e.g., parallel to Arrow D). More importantly, the distance that the plunger 323 is pushed within the wire coil(s) 324 is linearly related to the output voltage of the LVDT circuit over a determined range of distances depending on the specific LVDT circuit designed. The output voltage of the LVDT circuit is measured and compared to a plurality of stored voltage values, which are associated with a plurality of types of calibration information. The calibration information having an associated stored voltage value (within an acceptable boundary) closest to the measured voltage value is applied. It is contemplated that the LVDT circuit may be implemented either in analog or digital. However, utilizing digital LVDT circuits may be more cost effective.
In some variable inductor embodiments, the plunger 323 may be made from electrically conductive material(s) such as, for example, silicon carbide, graphite, silver, gold, platinum, other metals, metal alloys, or combinations thereof. According to these embodiments, an LC circuit is formed by the wire coil(s) 324 and the plunger 323. As previously described, the distance that the plunger 323 is pushed determines the inductance of the wire coil(s) 324. The change in inductance of the wire coil(s) 324 correspondingly alters the resonant frequency of the LC circuit. The resonant frequency may be measured by, for example, coupling to a probe coil, a frequency counter, or an AC bridge. The measured resonant frequency value is compared to a plurality of stored resonant frequency values, which are associated with a plurality of types of calibration information. The calibration information having an associated stored resonant frequency value (within an acceptable boundary) closest to the measured resonant frequency value is applied. Alternatively, a base-line resonant frequency may be established for the LC circuit when no test sensor 110 is inserted within the test-sensor opening 325. When a test sensor 110 is inserted into the test-sensor opening 325, deviations of the resonant frequency from the base-line resonant frequency are measured and compared to a plurality of stored resonant frequency deviations as described above. In other variable inductor LC circuit embodiments, the reactance of the LC circuit may be measured by, for example, a frequency counter or an AC bridge. The measured reactance value is compared to a plurality of stored reactance values as described above.
According to other embodiments of the present invention, a test-sensor combination may be used with a variable capacitor to determine calibration information corresponding with a particular test sensor. The variable capacitor may be comprised of components housed entirely within a meter or, alternatively, a portion of the variable capacitor may be included on a test sensor. Regardless of the location of the components of the variable capacitor, the capacitance of the variable capacitor may be varied by increasing or decreasing the surface area of the components of the variable capacitor. For example, the variable capacitor may be a parallel plate capacitor with differently sized plates. Assuming the distance separating the plates remains constant, increasing the size (i.e., surface area) of the smaller plate, increases the surface area of the parallel plate capacitor, thus, directly increasing the capacitance of the parallel plate capacitor. Another type of variable capacitor may be a set of concentric cylinders where one cylinder can be slid in or out of an opposing cylinder. As the inner cylinder is slid further into the outer cylinder, the surface area and, thus, capacitance of the variable capacitor increases. Likewise, as the inner cylinder is moved out of the outer cylinder, the capacitance decreases. Concentric cylinder variable capacitors may be desirable because the distance between the cylinders remains constant. Alternatively, the capacitance of the variable capacitor may be varied by changing the type of dielectric material that is between the capacitor plates, cylinders, or components.
The test sensors are generally configured to interact with the variable capacitor such that the measured capacitance of the variable capacitor directly depends upon characteristics of the particular test sensor inserted. The measured capacitance is compared to stored capacitances corresponding with particular types of calibration information. Each stored capacitance associated with each different type of test sensor includes an acceptable boundary or deviation. The acceptable boundary is based upon the accuracy of the variable capacitor system. The calibration information having an associated stored capacitance closest to the measured capacitance and within the acceptable boundary of the stored capacitance is applied.
The variable capacitor 420 illustrated in
When the test sensor 110 is inserted through the test-sensor opening 425, the one or more notches 121 in the test sensors 110 receive and push the plunger 423 a distance within the sleeve 428, thereby varying the capacitance of the variable capacitor 420. The depth of the notch 121 determines the distance that the plunger 423 moves, which corresponds to the capacitance of the variable capacitor 420. The capacitance may be directly measured by, for example, a frequency counter or an AC bridge. The measured capacitance value is compared to stored capacitance values corresponding with particular types of calibration information. The calibration information having an associated stored capacitance value (within an acceptable boundary) closest to the measured capacitance value and within the acceptable boundary of the stored capacitance is applied.
The depth of the notch 121 is, thus, varied among test sensors 110 having different calibration information. As previously described, test sensors having notches of different depths push the plunger 423 different distances into the sleeve 428. More specifically, test sensors having notches of greater depths push the plunger 423 shorter distances, and test sensors having notches of smaller depths push the plunger 423 larger distances.
Without a test sensor 510a inserted through the test-sensor opening 525, the variable capacitor has negligible, if any, measured capacitance because there is no parallel plate capacitor formed by the sensor plate 534a and meter plate 536. Upon inserting a test sensor 510a through the test-sensor opening 525, at least a portion of the sensor plate 534a overlaps with the meter plate 536, thereby forming a parallel plate variable capacitor across the two conductive surfaces. The surface area of the overlapping portions of the sensor plate 534a and the meter plate 536 determines the surface area of the variable capacitor, which directly corresponds to the capacitance of the variable capacitor.
The capacitance may be measured by, for example, a frequency counter or an AC bridge. The measured capacitance value is compared to stored capacitance values corresponding with particular types of calibration information. The calibration information having an associated stored capacitance value (within an acceptable boundary) closest to the measured capacitance value is applied.
The size of the sensor plate is, thus, smaller than the meter plate 536 and is varied among test sensors having different calibration information. It is contemplated that the size of the sensor plate 534a may be varied according to positioning, width, length, or any combinations thereof as shown, for example, by a test sensor 510b having sensor plate 534b. Varying the size of the sensor plate, varies surface areas for the variable capacitor. More specifically, test sensors having sensor plates of greater size cause the variable capacitor to have a larger surface area and, thus, larger measured capacitance values. Likewise, test sensors having sensor plates of smaller sizes cause the variable capacitor to have a smaller surface area and, thus, smaller measured capacitance values. It is contemplated that the size of the sensor plate may be fabricated by, for example, laser trimming or other suitable methods.
When no test sensor 610 is positioned within the test-sensor opening 625, the dielectric between the electrode plates 644a,b is air. However, when a test sensor 610 is inserted through the test-sensor opening 625, a sensor portion 642 of the test sensor 610 is positioned between the electrode plates 644a,b and, thus, the dielectric between the electrode plates 644a,b is a product of the physical characteristics of the sensor portion 642. Physical characteristics of the sensor portion 642 that affect the dielectric include, but are not limited to, material type, thickness, size, combinations thereof, or the like.
When the dielectric between electrode plates 644a,b changes, the capacitance of the variable capacitor changes correspondingly. As a result, when test sensors having sensor portions 642 of different dielectric characteristics are inserted into the meter 622, different capacitances are measured for the variable capacitor. The characteristics of the sensor portion 642 between the electrode plates 644a,b are, thus, varied among test sensors 610 having different calibration information. For example, test sensors having different calibration information associated therewith may include sensor portions 642 having different sizes, thicknesses, materials, combinations thereof, or the like.
The capacitance values of the variable capacitor are measured by, for example, a frequency counter or an AC bridge. The measured capacitance value is compared to stored capacitance values corresponding with particular types of calibration information. The calibration information having an associated stored capacitance value (within an acceptable boundary) closest to the measured capacitance value is applied. It is contemplated that instead of or in addition to capacitance, the frequency of the variable capacitor may be measured and compared, as previously described, to determine the associated calibration information for a particular test sensor 610.
According to other embodiments of the present invention, a test-sensor combination may be used with one or more piezoelectric elements to determine calibration information corresponding to a particular test sensor.
When the test sensor 110 is inserted through the test-sensor opening 725, the notch 121 contacts the piezoelectric element 720 and compresses the piezoelectric element 720, thereby generating an output voltage on the piezoelectric element 720. The depth of the notch 121 determines the amount of compression, which corresponds to the measured voltage. The measured voltage is compared to stored voltages corresponding with particular types of calibration information. Each stored voltage associated with each different type of test sensor includes an acceptable boundary or deviation. The acceptable boundary is determined based upon the accuracy of the piezoelectric element 720. The calibration information having an associated stored voltage closest to the measured voltage and within the acceptable boundary of the stored voltage is applied.
The depth of the notch(es) are, thus, varied among test sensors having different calibration information. Test sensors having notches of different depths compress the piezoelectric element 720 different distances. More specifically, test sensors having notches of greater depths compress the piezoelectric element 720 shorter distances, and test sensors having notches of smaller depths compress the piezoelectric element 720 larger distances.
Any of the test sensors described above with respect to
In one non-limiting embodiment, a maximum notch-depth corresponds with a default position of the actuator of
The accuracy and sensitivity of devices such as the potentiometer, variable inductor, variable capacitor, or piezoelectric element must be considered when determining how many notch depths and, accordingly, how many different types of calibration information may be ascertained by the devices. More accurate and sensitive devices may detect and distinguish more minor variations in the measured values and notch depths. Thus, more accurate devices may be used to distinguish a series of test sensors having a larger number of notch-depth variations.
To provide error checking for each of the test sensors described with respect to
To provide additional error checking for the meter, the resistance of the potentiometer, the inductance of the variable inductor, the capacitance of the variable capacitor, or output voltage of the piezoelectric element may be measured when no test sensor is present. This resistance, inductance, capacitance, or output voltage may then be compared to the expected default value. Such error checking may be used to detect, for example, a defective potentiometer, e.g., one in which the actuator is stuck, has a broken spring mechanism, or the like.
Additionally, because the operating characteristics of each individual potentiometer, variable inductor, variable capacitor, or piezoelectric element may vary from device to device, the meter used with the assemblies described with respect to
Assemblies such as those illustrated in
All of the sensors and assemblies described herein may be desirable because they may support many different types of calibration information. The test sensors may be used as single stand-alone test sensors. The test sensors of the embodiments described herein may also be stored in a cartridge.
In the embodiments described herein, it is important that the test sensors are fully inserted into the test-sensor opening for the calibration information to be correctly ascertained. Thus, the meters used with the test sensors may include a mechanism for determining whether the test sensors are fully inserted. The mechanism may be positioned, for example, in or adjacent to the test-sensor opening. The meter may further be adapted to report an error to a user if it detects that the test sensor is not fully inserted.
After the test sensors illustrated and described above in
The calibration information referred to herein may be any information that may be used by a meter or instrument. For example, the calibration information may be a program auto-calibration number that relates to a slope and intercept of calibration lines for the test sensor lot or batch. In addition to calibration information, other information may be contained such an analyte type or manufacturing date.
While the present invention has been described with reference to one or more particular embodiments, those skilled in the art will recognize that many changes may be made thereto without departing from the spirit and scope of the present invention. Each of these embodiments and obvious variations thereof is contemplated as falling within the spirit and scope of the claimed invention, which is set forth in the following claims.
This application claims the benefit of U.S. Provisional Patent Application No. 61/065,873, filed Feb. 15, 2008 entitled “Auto-Calibrating Test Sensors”, which is hereby incorporated by reference in its entirety.
Number | Date | Country | |
---|---|---|---|
61065873 | Feb 2008 | US |