Encoded biosensors and methods of manufacture and use thereof

• US 9,267,911 B2
• Filed: 11/17/2014
• Issued: 02/23/2016
• Est. Priority Date: 07/29/2011
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Austera, John T., Beaty, Terry A., Joseph, Abner D., Manlove, Nathan E., Moore, Steven K., Pauley, James L. Jr., Riggles, Randall K.
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US14/542,755
• Publication Number:
  US 20150076010A1
• Time in Patent Office: 463 Days
• US Class Current: 1/1
• 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

Abstract

An analyte test sensor strip is disclosed having information coded thereon as well as a method of forming the same and conducting an analyte test using the analyte test sensor strip. Information relating to an attribute of the strip or batch/lot of strips may be coded based on resistance values pertaining to electrical aspects of the strip, such as a primary resistive element and a secondary resistive element, the secondary resistive element having one of a plurality of states defined by a location of a closed tap to form a unique resistive path for the secondary resistive element that includes a portion of the primary resistive element depending on the location of the closed tap. The states may be formed on the strip by a secondary processing step in the manufacture of the strip in which a plurality of taps are severed leaving only one tap in a closed state.

Claims

1. An analyte test sensor strip, comprising:

a non-conductive substrate;

a plurality of measurement electrodes formed on the non-conductive substrate, wherein the plurality of measurement electrodes comprises at least a working electrode and a counter electrode;

a reagent bridging the working electrode and the counter electrode;

an information circuit formed on the non-conductive substrate, the information circuit comprising;

a primary resistive element having a first end and a second end having a predetermined configuration between the first and second ends, wherein the primary resistive element has a resistance falling within a first predetermined range, and

a secondary resistive element between the first end of the primary resistive element and a third end, wherein the secondary resistive element comprises a plurality of closed taps, wherein the closed taps selectively connect the third end with the primary resistive element each at a predetermined location thereby defining a plurality of selectable, unique resistive paths between the first end and the third end through at least a portion of the primary resistive element, wherein each of the plurality of selectable, unique resistive paths has a second resistance falling within a second predetermined range; and

a plurality of contact pads formed on the non-conductive substrate, wherein at least a first contact pad of the plurality of contact pads is connected to the first end of the primary resistive element, a second contact pad of the plurality of contact pads is connected to the second end of the primary resistive element, and a third contact pad of the plurality of contact pads is connected to a portion of the secondary resistive element;

wherein a ratio of the first resistance and the second resistance selectively correlates to an attribute of the analyte test sensor strip.

2. The analyte test sensor strip of claim 1, wherein the predetermined configuration of the primary resistive element comprises a serpentine configuration having a plurality of proximal ends and a plurality of distal ends.

3. The analyte test sensor strip of claim 2, wherein each of the plurality of closed taps of the secondary resistive element is connected to a respective proximal end of the primary resistive element.

4. The analyte test sensor strip of claim 1, wherein each of the plurality of closed taps can be selected as a function of an attribute of the analyte test sensor strip.

5. The analyte test sensor strip of claim 1, further comprising an optical code on the non-conductive substrate.

6. The analyte test sensor strip of claim 5, wherein the optical code contains at least one informational attribute associated with the analyte test sensor strip selected from the group consisting of a product expiration date, a product identification, intercepts of blood and control solution information, a strip lot identification, and a strip performance algorithm identifier.

7. A method of measuring an analyte concentration in a sample of fluid, comprising:

inserting the analyte test sensor strip of claim 1 into a test meter, wherein the working electrode, the counter electrode, the primary resistive element, and the secondary resistive element connect to the test meter through the plurality of contact pads;

determining an attribute associated with analyte test sensor strip as a function of a measurement associated with at least the resistance value associated with at least one of the plurality of selectable, unique resistive paths;

configuring the test meter as a function of the attribute;

applying the sample of fluid and measuring the analyte concentration; and

displaying a measurement of the analyte concentration on a display of the test meter;

wherein the primary resistive element has a primary element resistance value and the attribute is determined as a function of a resistance ratio determined by comparing the resistance value of at least one of the plurality of selectable, unique resistive paths with the primary element resistance value.

8. The method of claim 7, wherein an end of the primary resistive element is connected with the counter electrode.