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No calibration analyte sensors and methods / Abbott Diabetics Care Inc.




Title: No calibration analyte sensors and methods.
Abstract: A meter and sensors, for use in combination, where no calibration code has to be entered by the user or is read by the meter. The meter is configured with a predetermined slope and y-intercept built into the meter. If the slope and y-intercept of the sensor are within a predetermined area or grid, or otherwise close to the slope and y-intercept of the meter, the batch of sensors is acceptable for use with that meter for providing accurate analyte concentration results. ...


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USPTO Applicaton #: #20120318670
Inventors: Shridhara Alva Karinka, Yi Wang


The Patent Description & Claims data below is from USPTO Patent Application 20120318670, No calibration analyte sensors and methods.

CROSS REFERENCE TO RELATED APPLICATIONS

This Application claims priority to U.S. Provisional Application No. 60/914,590 filed on Apr. 27, 2007, titled “NO CALIBRATION ANALYTE SENSORS AND METHODS,” the disclosure of which is hereby incorporated by reference in its entirety.

BACKGROUND

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Biosensors, also referred to as analytical sensors or merely sensors, are commonly used to determine the presence and concentration of a biological analyte in a sample. Such biosensors are used, for example, to monitor blood glucose levels in diabetic patients.

As sensors continue to be used, there continues to be an interest in sensors that are easy to manufacture and easy for a patient to use.

SUMMARY

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The present disclosure provides sensors and methods for the detection and quantification of an analyte in a sample. The sensors are configured to provide a clinically accurate analyte level reading, without the user having to enter a calibration code or the like that corresponds to the sensor. The sensors are configured to be used with a meter that has a predetermined calibration code present therein. Embodiments of the sensor are provided, by the manufacturer of the sensors, with a configuration that provides a standardized calibration.

In general, certain embodiments of the present disclosure include sensors for analysis of an analyte in a sample, e.g., a small volume sample, by, for example, coulometry, amperometry and/or potentiometry. The sensors include at least a working electrode and a counter electrode, which may be on the same substrate (e.g., co-planar) or may be on different substrates (e.g., facing). The sensors also include a sample chamber to hold the sample in electrolytic contact with the working electrode. A sensor according to the present disclosure may utilize an electron transfer agent and/or a redox mediator. The sensors may be made with at least one substrate and configured for side-filling, tip-filling, or top-filling. In addition, in some embodiments, the sensor may be part of an integrated sample acquisition and analyte measurement device. An integrated sample acquisition and analyte measurement device may include a sensor and a skin piercing member, so that the device can be used to pierce the skin of a user to cause flow of a fluid sample, such as blood, that may then be collected by the sensor. In at least some embodiments, the fluid sample may be collected without moving the integrated sample acquisition and analyte measurement device.

Various embodiments of methods of making sensors, according to this disclosure, include providing a sample chamber and/or measurement zone having an electrode surface area that, when filled with a sample to be tested, provides a clinically accurate analyte level reading, without the user having to enter a calibration code or the like that corresponds to the sensor, into a meter that is used to read the sensor. The meter is configured with a predetermined slope and y-intercept built into the meter. If the slope and y-intercept (which relate to the calibration code) of the sensor are within a predetermined area or grid, or otherwise close to the slope and y-intercept of the meter, the batch of sensors is acceptable for use with that meter.

In certain embodiments, one particular method of forming a sensor, as described further below, includes forming at least one working electrode on a first substrate and forming at least one counter or counter/reference electrode on a second substrate. A spacer layer is disposed on either the first or second substrates. The spacer layer defines a chamber into which a sample may be drawn and held when the sensor is completed. Chemistry for detecting one or more analytes may be present on the first or second substrate in a region that will be exposed within the sample chamber when the sensor is completed. The first and second substrates may then be brought together and spaced apart by the spacer layer with the sample chamber providing access to the at least one working electrode and the at least one counter or counter/reference electrode. Any or all of the volume of the sample chamber, the volume of the measurement zone, the surface area of the electrode(s) within the sample chamber and/or measurement zone, may be adjusted during the manufacturing process so that the resulting sensor meets certain criteria.

Certain other embodiments include forming at least one working electrode on a first substrate and forming at least one counter or counter/reference electrode on the same, first substrate. One or two additional layers may be added to define a chamber into which a sample may be drawn and held when the sensor is completed. Chemistry may be present in a region that will be exposed within the sample chamber when the sensor is completed. The substrates may then be brought together, forming a sample chamber providing access to the at least one working electrode and the at least one counter or counter/reference electrode. In some embodiments, the volume of the sample chamber, and optionally the volume of the measurement zone, may be adjusted so that the resulting sensor meets certain criteria. Adjusting the volume of the sample chamber may or may not modify the electrode area. Additionally or alternately, in some embodiments, the surface area of the at least one working electrode and/or the at least one counter or counter/reference electrode are adjusted so that the resulting sensor meets certain criteria. Adjusting the electrode area may or may not modify the volume of the sample chamber.

These and various other features which characterize some embodiments according to the present disclosure are pointed out with particularity in the attached claims. For a better understanding of the embodiments, their advantages, and objectives obtained by their use, reference should be made to the drawings and to the accompanying description, in which there is illustrated and described particular embodiments according to the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

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Referring now to the drawings, wherein like reference numerals and letters indicate corresponding structure throughout the several views:

FIG. 1 is a schematic perspective view of a first embodiment of a sensor strip in accordance with the present disclosure;

FIG. 2A is an exploded view of the sensor strip shown in FIG. 1, the layers illustrated individually with the electrodes in a first configuration;

FIG. 2B is a top view of the sensor strip shown in FIGS. 1 and 2A;

FIG. 3A is a schematic view of a second embodiment of a sensor strip in accordance with the present disclosure, the layer illustrated individually with the electrodes in a second configuration;

FIG. 3B is a top view of the sensor strip shown in FIG. 3A;

FIG. 4 is a top view of the first substrate of the sensor strip of FIGS. 3A and 3B;

FIG. 5 is a schematic perspective view of another embodiment of a sensor strip in accordance with the present disclosure;

FIG. 6 is a top perspective view of a sensor strip positioned for insertion within an electrical connector device in accordance with the present disclosure;

FIG. 7 is a graphical distribution of results around the calibration position based on standard deviation;

FIG. 8 is a graphical range of slope and intercept with respect to a fixed point that would meet the ISO requirements at a given glucose level; and

FIG. 9 is a graphical range of slope and intercept with respect to a fixed point that would meet the ISO requirements at multiple glucose levels.

FIG. 10 is a schematic block diagram of a meter according to the present disclosure.

DETAILED DESCRIPTION

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In some currently available analyte testing systems, a value indicative of the calibration code of a sensor is manually entered into the meter or other equipment, for example, by the user. Based on the calibration code, the meter uses one of several programs or parameters stored within the meter. In other currently available systems, the sensor calibration code is directly read by the meter or other equipment, thus not requiring input or other interaction by the user. These sensors, however, still have a calibration code associated with them, which includes slope and y-intercept values. The slope and y-intercept values are used to determine the analyte concentration based on the measured signal. The calibration code, whether inputted manually or automatically, is needed to standardize the analysis results received from non-standardized sensors. In other words, different sensors vary, e.g., from lot to lot, a sufficient amount that, if no compensation were made, the results would differ from sensor to sensor and the results could be clinically inaccurate.

The sensors of this disclosure are calibration-adjusted to a pre-determined calibration (slope and y-intercept), during the manufacturing process, to avoid the need for the user to input or otherwise set a calibration code for the sensor or perform other calibration procedure(s) before using the sensor. The sensors of this disclosure are also calibration-adjusted to avoid the need for the meter to read a calibration code.

This disclosure also provides methods for making sensors that avoid the need for the user to input or otherwise set a calibration code for the sensor, or perform other calibration procedure(s) before using the sensor. The approach described here does not require any additional steps from the user to perform a test. The manufacturing is simple and does not require special packaging or encoding the strips with calibration information.




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stats Patent Info
Application #
US 20120318670 A1
Publish Date
12/20/2012
Document #
File Date
12/31/1969
USPTO Class
Other USPTO Classes
International Class
/
Drawings
0




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Abbott Diabetics Care Inc.


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Chemistry: Electrical And Wave Energy   Apparatus   Electrolytic   Analysis And Testing   With Significant Electrical Circuitry Or Nominal Computer Device  

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20121220|20120318670|no calibration analyte sensors and methods|A meter and sensors, for use in combination, where no calibration code has to be entered by the user or is read by the meter. The meter is configured with a predetermined slope and y-intercept built into the meter. If the slope and y-intercept of the sensor are within a |Abbott-Diabetics-Care-Inc
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