Biosensor

• US 7,780,827 B1
• Filed: 06/22/2005
• Issued: 08/24/2010
• Est. Priority Date: 08/29/2001
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Pauley, James L. Jr., Walling, Douglas P., Ranney, Timothy L., Groll, Henning, Bhullar, Raghbir S., Austera, John T.
• Primary Examiner(s): Olsen; Kaj K
• Application Number:
  US11/158,772
• Publication Number:
  US 20100219071A1
• Time in Patent Office: 1,889 Days
• Field of Search: 204/403.01, 204/403.02, 204/406
• US Class Current: 204/403.02
• CPC Class Codes: G01N 2035/00811 consumable or exchangeable components other than sample carriers, e.g. detectors, flow cells
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

The present invention relates to a biosensor. The biosensor includes a support substrate, an electrically conductive coating positioned on the support substrate, the coating being formed to define electrodes and a code pattern, wherein there is sufficient contrast between the conductive coating and the substrate such that the code pattern is discernible, and a cover cooperating with the support substrate to define a channel. At least a portion of the electrodes are positioned in the channel.

Claims

1. A system comprising:

a test meter including a connector operatively connected to electronics of the meter and having a plurality of contact pairs provided in the connector, and a biosensor configured for insertion into the test meter for operatively attaching the biosensor to the electronics, the biosensor comprising a code pattern formed thereon, the code pattern comprising a two-dimensional array of a plurality of possible pad locations wherein at least one of the possible pad locations comprises a pad having electrical continuity, wherein the plurality of contact pairs in the connector is configured so that there is one contact pair aligned with each possible pad location once the biosensor is inserted into the test meter, and wherein the electronics are configured to perform a continuity query at each possible pad location only when the biosensor is fully inserted into the connector in order to determine the presence or absence of a pad at each possible pad location.

2. The system of claim 1, the biosensor further including measurement electrodes defined on the biosensor and electrically isolated from the possible pad locations.

3. The system of claim 1, wherein the code pattern correlates to at least one characteristic of the biosensor.

4. The system of claim 1, wherein the code pattern is associated with at least one of an identification set or data set.

5. The system of claim 4, wherein the code pattern is associated with a data set comprising a set of calibration data for the biosensor.

6. The system of claim 4, wherein the code pattern is associated with an identification set that uniquely identifies the biosensor with a batch of biosensors.

7. The system of claim 4, wherein the code pattern is associated with a data set, the test meter including a memory unit for storing a plurality of predetermined lot information;

and wherein the test meter is configured to use the results of the continuity query to select a predetermined lot information corresponding to the data set and to set an appropriate code from the selected predetermined lot information in the test meter to eliminate lot-specific variations when testing a sample of fluid.

8. The system of claim 7, wherein the results of the continuity query comprise a determination of the code pattern by the test meter, and wherein the plurality of predetermined lot information is associated with calibration data, the test meter being configured to correlate the code pattern to calibration data in the memory unit and set the calibration data for the biosensor in the test meter.

9. The system of claim 7, wherein the code pattern further comprises an interconnectivity pattern wherein at least two of the possible pad locations comprises a pad having electrical continuity and being electrically interconnected with at least one other said pad, wherein the interconnectivity pattern provides various resistance levels among interconnected pads, the electronics of the meter being further configured to determine the resistance level between each pair of interconnected pads and wherein the various resistance levels are associated with at least one characteristic of the biosensor.

10. The system of claim 9, wherein the resistance level between at least one pair of interconnected pads correlates to a reagent lot.

11. The system of claim 9, wherein at least one pad is electrically interconnected with at least two other said pads.

12. The system of claim 1, wherein the test meter includes a memory unit, the memory unit storing predetermined lot information;

and wherein the test meter is configured to use the results of the continuity query to select predetermined lot information and set an appropriate code in the test meter to eliminate lot-specific variations of the biosensor when testing a sample of fluid.

13. The system of claim 1, wherein each of the at least one possible pad locations comprising a pad is coated with an electrical conductor that modifies the electrical resistivity of the pad.

14. The system of claim 1, wherein the code pattern further comprises an interconnectivity pattern wherein at least two of the possible pad locations comprises a pad having electrical continuity and being interconnected with at least one other said pad, wherein the interconnectivity pattern provides various resistance levels, the electronics of the meter being further configured to determine the resistance level between each pair of interconnected pads and wherein the various resistance levels are associated with at least one characteristic of the biosensor.

15. The system of claim 14, wherein the resistance level between at least one pair of interconnected pads correlates to a reagent lot.

16. The system of claim 14, the biosensor further including measurement electrodes defined on the biosensor and electrically isolated from the possible pad locations and from the interconnectivity pattern.

17. The system of claim 14, wherein at least one pad is electrically interconnected with at least two other said pads.

18. The system of claim 14, wherein the code pattern comprises at least three pads, the at least three pads forming a two-dimensional array, wherein the pairs of contacts in the connector each aligned with the respective pads are configured to contact the at least three pads simultaneously.

19. The system of claim 14, the biosensor further including measurement electrodes defined on the biosensor and electrically isolated from the possible pad locations and from the interconnectivity pattern, wherein the code pattern including the interconnectivity pattern is associated with an identification set and at least one data set, the identification set comprising at least one of reagent lot information and information uniquely identifying the biosensor with a batch of biosensors, the data set comprising at least calibration data for the biosensor, the test meter including a memory unit for storing a plurality of identification information and corresponding predetermined lot information, wherein the test meter is configured to correlate the code pattern and resistance levels as determined by the test meter to one of the predetermined lot information corresponding to the identification set and data set, and to set an appropriate code from the one predetermined lot information in the test meter to eliminate lot-specific variations when testing a sample of fluid.

20. The system of claim 1, wherein the code pattern comprises at least two pads each having electrical continuity and further comprises at least one possible internal link, each possible internal link spanning a pathway between at least two of the pads, wherein the presence of conductive material along a possible internal link comprises a link electrically connecting the pads associated with the possible internal link, and wherein the test meter is configured to determine presence of any said link and a resistance level between the pads associated with each possible internal link, and wherein various resistance levels determined by the test meter are each associated with at least one characteristic of the biosensor.

21. The system of claim 20, wherein the code pattern comprises at least two possible internal links between two pads.

22. The system of claim 20, wherein the various resistance levels include at least three distinct resistance levels.

23. The system of claim 20, wherein at least one of the various resistance levels determined by the test meter correlates to a reagent lot.