Methods and devices for determining sensing device usability

• US 9,201,034 B2
• Filed: 06/29/2012
• Issued: 12/01/2015
• Est. Priority Date: 06/30/2011
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Martin, Glenn, Wang, Yi, Tonks, Simon, Feldman, Benjamin J.
• Primary Examiner(s): Assouad, Patrick
• Assistant Examiner(s): Zhang, Haidong
• Application Number:
  US13/537,983
• Publication Number:
  US 20130002278A1
• Time in Patent Office: 1,250 Days
• US Class Current: 1/1
• CPC Class Codes: G01N 27/048 for determining moisture content of the material
• 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 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01R 35/005 Calibrating; Standards or reference devices, e.g. voltage or resistance standards, "golden" references G01R33/0035, G01R35/002 take precedence

Abstract

Methods and devices for determining sensing device usability, e.g., for self-monitoring and point of care devices. In one embodiment, the invention is to a method of determining device usability, comprising the steps of providing a device comprising a first electrical pad; a second electrical pad; and a humidity-responsive polymer layer contacting at least a portion of the first and second electrical pads; applying a potential across the first and second electrical pads; measuring an electrical property associated with the humidity-responsive polymer layer; and determining whether the measured electrical property associated with the humidity-responsive polymer layer has exceeded a humidity threshold level associated with the device usability.

Claims

1. A method of determining device usability of an analyte sensing device, comprising the steps of:

providing an analyte sensing device comprising a first electrical pad;

a second electrical pad; and

a humidity-responsive polymer layer contacting at least a portion of said first and said second electrical pads;

applying a potential across said first and said second electrical pads, wherein the first electrical pad is connected to an analyte sensing electrode and the second electrical pad is connected to a reference electrode;

measuring an electrical property associated with said humidity-responsive polymer layer; and

determining whether said measured electrical property associated with said humidity-responsive polymer layer has exceeded a humidity threshold level associated with said analyte sensing device usability,

wherein said humidity-responsive polymer layer is selected from the group consisting of a crosslinked polyvinylpyrrolidone (PVP), a crosslinked polymer containing nitrogen heterocyclic groups, and combinations thereof.

2. The method of claim 1, wherein said analyte sensing device is a glucose sensor or a ketone body sensor.

3. The method of claim 1, wherein said analyte sensing device is a sensor selected from the group consisting of a pH sensor, oxygen sensor, carbon dioxide sensor, hematocrit sensor, lactate sensor, creatinine sensor, sodium sensor, potassium sensor, chloride sensor, calcium sensor, BNP sensor, troponin sensor, CKMB sensor, NGAL sensor, TSH sensor, D-dimer sensor, PSA sensor, PTH sensor, cholesterol sensor, ALT sensor, AST sensor, prothrombin sensor, APTT sensor, ACT sensor, galectin sensor, and combinations thereof.

4. The method of claim 1, wherein said humidity-responsive polymer layer is substantially rectangular and has sides of length from about 20 μ

m to about 5 mm.

5. The method of claim 1, wherein said humidity-responsive polymer layer is applied to said device by a method selected from the group consisting of microdispensing, inkjet printing, and screen printing.

6. The method of claim 1, wherein said first electrical pad and said second electrical pad are separated by a distance of from about 10 μ

m to about 4 mm.

7. The method of claim 1, wherein said first electrical pad and said second electrical pad comprise terminal portions of contact lines.

8. The method of claim 1, wherein said first electrical pad and said second electrical pad comprise non-terminal portions of contact lines.

9. The method of claim 1, wherein said electrical property comprises current, resistance, impedance, conductivity, or combinations thereof.

10. The method of claim 1, wherein said potential comprises a sigmoidal potential cycle, a fixed applied potential, a sequence of fixed applied potential steps, or a combination thereof.

11. The method of claim 1, further comprising inserting said analyte sensing device into an analyzer configured to determine whether said measured electrical property associated with said humidity-responsive polymer layer has exceeded said humidity threshold level associated with said device usability.

12. A method of determining device usability of an analyte sensing device, comprising the steps of:

providing an analyte sensing device comprising a first electrical pad;

a second electrical pad; and

a humidity-responsive polymer layer contacting at least a portion of said first and said second electrical pads;

applying a potential across said first and said second electrical pads, wherein the first electrical pad is connected to an analyte sensing electrode and the second electrical pad is connected to a reference electrode;

measuring an electrical property associated with said humidity-responsive polymer layer; and

determining whether said measured electrical property associated with said humidity-responsive polymer layer has exceeded a humidity threshold level associated with said analyte sensing device usability,

wherein said humidity-responsive polymer layer is substantially circular and has a diameter of from about 20 μ

m to about 5 mm.

13. A method of determining device usability of an analyte sensing device, comprising the steps of:

providing an analyte sensing device comprising a first electrical pad;

a second electrical pad; and

a humidity-responsive polymer layer contacting at least a portion of said first and said second electrical pads;

measuring an initial current value associated with said humidity-responsive polymer layer when said analyte sensing device is manufactured;

applying a potential across said first and said second electrical pads, wherein the first electrical pad is connected to an analyte sensing electrode and the second electrical pad is connected to a reference electrode;

measuring an electrical property associated with said humidity-responsive polymer layer; and

determining whether said measured electrical property associated with said humidity-responsive polymer layer has exceeded a humidity threshold level associated with said analyte sensing device usability,

wherein said humidity threshold level is at least five times higher than said initial current value.

14. A method of determining device usability of an analyte sensing device, comprising the steps of:

providing an analyte sensing device comprising a first electrical pad;

a second electrical pad; and

a humidity-responsive polymer layer contacting at least a portion of said first and said second electrical pads;

measuring an initial impedance value associated with said humidity-responsive polymer layer when said analyte sensing device is manufactured;

applying a potential across said first and said second electrical pads, wherein the first electrical pad is connected to an analyte sensing electrode and the second electrical pad is connected to a reference electrode;

measuring an electrical property associated with said humidity-responsive polymer layer; and

determining whether said measured electrical property associated with said humidity-responsive polymer layer has exceeded a humidity threshold level associated with said analyte sensing device usability,

wherein said humidity threshold level is at least five times lower than said initial impedance.