Methods and Devices for Determining Sensing Device Usability

• US 20130002265A1
• Filed: 06/29/2012
• Published: 01/03/2013
• 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, Zhao, Tian-Xian, Snyder, Stephen Lee
• Granted Patent: US 9,792,838 B2
• Time in Patent Office: Days
• US Class Current: 324/601
• CPC Class Codes: G01N 27/06 of a liquid involving electrolysis G01N27/26
• 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: G09F 3/0291 Labels or tickets undergoing a change under particular conditions, e.g. heat, radiation, passage of time

Abstract

Methods and devices for determining device usability, e.g., for point of care assay devices. In one embodiment, the invention is to a method of determining device usability in a sensing device, including the steps of: providing a device comprising a first electrical pad; a second electrical pad; and a first polymer layer contacting at least a portion of the first and the second electrical pads and a second polymer layer contacting the first polymer layer and not the first and second electrical pads; applying a potential across the first and the second electrical pads; measuring an electrical property associated with the first and the second polymer layers; and determining whether the measured electrical property associated with the first and the second polymer layers has exceeded a threshold level associated with the device usability.

Claims

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

providing a device comprising a first electrical pad;

a second electrical pad; and

a first polymer layer contacting at least a portion of said first and said second electrical pads and a second polymer layer contacting said first polymer layer and not said first and said second electrical pads;

applying a potential across said first and said second electrical pads;

measuring an electrical property associated with said first and said second polymer layers; and

determining whether the measured electrical property associated with said first and said second polymer layers has exceeded a threshold level associated with said device usability.

2. The method of claim 1, wherein said first polymer layer comprises a polymer matrix and a plasticizer.

3. The method of claim 2, wherein said second polymer layer comprises a polymer matrix, a plasticizer, and an organic salt.

4. The method of claim 3, wherein said first and said second polymer layers each comprise from 20 to 40 wt. % polymer matrix.

5. The method of claim 4, wherein said polymer matrix in each layer comprises a polymer selected from a group consisting of polyvinyl chloride, polyurethane, polyvinylacetate, carboxylated PVC, hydroxylated PVC and polydimethyl siloxane.

6. The method of claim 5, wherein said first and said second polymer layers each comprise from 60 to 80% plasticizer.

7. The method of claim 6, wherein said plasticizer in each layer is selected from a group consisting of trioctyl phosphate (TOP), nitrophenyloctyl ether (NPOE), bisethylhexylsebacate (BEHS), trimethyl trimellitate (TMTT), dioctyl adipate (DOA) and diisobutyl phthalate (DIBP).

8. The method of claim 7, wherein said second polymer layer comprises from 0.1 to 10 wt. % of an organic salt.

9. The method of claim 7, wherein said second polymer layer comprises a salt selected from the group consisting of quaternary ammonium tetrakis phenylborate, dodecyl sulfosuccinate, lauryl sulfate, alkyl ether phosphates, benzylkonium, cetylpyrdinium dodecyl sulfosuccinate, lauryl sulfate, alkyl ether phosphates, tetramethylammonium, benzylkonium, cetylpyrdinium, an iodide, a bromide, a perchlorate, a zwitterionic compound, cocamidopropyl hydroxysultaine and quaternary ammonium borate.

10. The method of claim 1, wherein said first polymer layer is substantially circular and has a diameter of from about 20 μ

m to about 2 mm.

11. The method of claim 1, wherein said second polymer layer is substantially circular and has a diameter of from about 20 μ

m to about 2 mm, and wherein the diameter is less than the first polymer layer.

12. The method of claim 1, wherein said device further comprises a boundary structure for controlling the spreading of a dispensed first polymer layer precursor to a predetermined region of said device.

13. The method of claim 1, wherein said device further comprises a boundary structure for controlling the spreading of a dispensed second polymer layer precursor to a predetermined region of the device.

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

m to about 2 mm.

15. The method of claim 1, wherein said first and said second polymer layers are domed.

16. The method of claim 1, wherein said electrical property comprises current, resistance, impedance, conductivity, or a combination thereof.

17. The method of claim 16, further comprising measuring an initial current value associated with said first and said second polymer layers when said device is manufactured and wherein said threshold level is at least five times greater than said initial current value.

18. The method of claim 16, further comprising measuring an initial impedance value associated with said first and said second polymer layers when said device is manufactured, wherein said threshold level is at least five times less than said initial impedance.

19. 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.

20. The method of claim 1, wherein said potential comprises a potential cycle that is applied at a predetermined frequency in the range of about 1 Hz to about 100000 Hz.

21. The method of claim 1, further comprising inserting said device into an analyzer configured to determine whether said measured electrical property associated with said first and said second polymer layers has exceeded said threshold level associated with said device usability.

22. The method of claim 1, where said device further comprises a sensor selected from a group consisting of a pH sensor, oxygen sensor, carbon dioxide sensor, hematocrit sensor, glucose 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

23. A method of claim 1, where said first polymer layer is printed onto said device in a first step and said second polymer layer is printed onto said first layer in a second step.

24. A method of claim 1, where said second polymer layer is printed onto said device in a first step and said first polymer layer is printed onto said device and covering said second layer in a second step.

25. A method of claim 1, where said electrical response is dependent on an organic salt migrating from said second polymer layer into said first polymer layer, wherein said migration is time and temperature dependent.

26. A device having a usability threshold, comprising:

a first electrical pad;

a second electrical pad;

a first polymer layer electrically contacting at least a portion of said first and said second electrical pads; and

a second polymer layer contacting said first polymer layer and not contacting said first and said second electrical pads,

wherein said first and said second polymer layers have an electrical property associated with said device usability threshold.

27. A device comprising:

a sensor;

a first polymer layer formed on a surface of said device;

a second polymer layer formed on said first polymer layer;

a first electrical pad; and

a second electrical pad,

wherein;

said surface comprises said first and said second electrical pads positioned adjacent to one another and a space therebetween;

said first polymer layer covers at least a portion of said first and said second electrical pads and a portion of said space therebetween;

said second polymer layer contacts said first polymer layer and not said first and said second electrical pads;

a preselected potential or potential cycle is applied to said first and said second electrical pads and an impedance or current associated with said first and said second polymer layers is measured; and

said measured impedance or current is converted to a value indicative of an average shelf life time remaining for other devices from a same manufacturing lot of said device.

28. A method of determining device usability, comprising the steps of:

providing a device comprising a first electrical pad;

a second electrical pad; and

a first polymer layer contacting at least a portion of said first and said second electrical pads and a second polymer layer contacting said first polymer layer and not said first and said second electrical pads;

applying a potential across said first and said second electrical pads;

measuring an electrical property associated with said first and said second polymer layers; and

determining a correction factor associated with said measured electrical property; and

applying said correction factor to a signal generated by a sensor to produce a corrected signal.

29. The method of claim 28, wherein said correction factor is selected from a group consisting of an amperometric correction value, a potentiometric correction value, a coulombic correction value and a conductivity correction value.

30. The method of claim 28, wherein said sensor is selected from a group consisting of a pH sensor, an oxygen sensor, a carbon dioxide sensor, a hematocrit sensor, a glucose sensor, a lactate sensor, a creatinine sensor, a sodium sensor, a potassium sensor, a chloride sensor, a calcium sensor, a BNP sensor, a troponin sensor, a CKMB sensor, a NGAL sensor, a TSH sensor, a D-dimer sensor, a PSA sensor, a PTH sensor, a cholesterol sensor, an ALT sensor, an AST sensor, a prothrombin sensor, an APTT sensor, an ACT sensor and a galectin sensor.

31. The method of claim 28, wherein said first polymer layer comprises a polymer matrix and a plasticizer.

32. The method of claim 31, wherein said second polymer layer comprises a polymer matrix, a plasticizer, and an organic salt.

33. The method of claim 32, wherein said electrical property comprises current, resistance, impedance, conductivity, or a combination thereof.

34. The method of claim 33, further comprising measuring an initial current value associated with said first and said second polymer layers when said device is manufactured and wherein said threshold level is at least five times greater than said initial current value.

35. The method of claim 33, further comprising measuring an initial impedance value associated with said first and said second polymer layers when said device is manufactured, wherein said threshold level is at least five times less than said initial impedance.

36. The method of claim 28, wherein said potential comprises a sigmoidal potential cycle, a fixed applied potential, a sequence of fixed applied potential steps, or a combination thereof.

37. The method of claim 28, wherein said potential comprises a potential cycle that is applied at a predetermined frequency in the range of about 1 Hz to about 100000 Hz.

38. The method of claim 28, further comprising inserting said device into an analyzer configured to determine whether said measured electrical property associated with said first and said second polymer layers has exceeded a threshold level associated with said device usability.

39. A method of determining device usability, comprising the steps of:

providing a device comprising a first electrical pad;

a second electrical pad; and

a first polymer layer contacting at least a portion of said first electrical pad and a second polymer layer contacting at least a portion of said second electrical pad and at least a portion of said first polymer layer;

applying a potential across said first and said second electrical pads;

measuring an electrical property associated with said first and said second polymer layers; and

determining whether the measured electrical property associated with said first and said second polymer layers has exceeded a threshold level associated with said device usability.

40. The method of claim 39, wherein said first polymer layer comprises a polymer matrix and a plasticizer.

41. The method of claim 40, wherein said second polymer layer comprises a polymer matrix, a plasticizer, and an organic salt.

42. The method of claim 41, wherein said first and said second polymer layers each comprises from 20 to 40 wt. % polymer matrix.

43. The method of claim 42, wherein said polymer matrix in each layer comprises a polymer selected from a group consisting of polyvinyl chloride, polyurethane, polyvinylacetate, carboxylated PVC, hydroxylated PVC and polydimethyl siloxane.

44. The method of claim 43, wherein said first and said second polymer layers each comprises from 60 to 80% plasticizer.

45. The method of claim 44, wherein said plasticizer in each layer is selected from a group consisting of trioctyl phosphate (TOP), nitrophenyloctyl ether (NPOE), bisethylhexylsebacate (BEHS), trimethyl trimellitate (TMTT), dioctyl adipate (DOA) and diisobutyl phthalate (DIBP).

46. The method of claim 45, wherein said second polymer layer comprises from 0.1 to 10 wt. % of an organic salt.

47. The method of claim 46, wherein said second polymer layer comprises a salt selected from the group consisting of quaternary ammonium tetrakis phenylborate, dodecyl sulfosuccinate, lauryl sulfate, alkyl ether phosphates, benzylkonium, cetylpyrdinium dodecyl sulfosuccinate, lauryl sulfate, alkyl ether phosphates, tetramethylammonium, benzylkonium, cetylpyrdinium, an iodide, a bromide, a perchlorate, a zwitterionic compound, cocamidopropyl hydroxysultaine and quaternary ammonium borate.

48. The method of claim 39, wherein said first polymer layer is substantially circular and has a diameter of from about 20 μ

m to about 2 mm.

49. The method of claim 39, wherein said second polymer layer is substantially circular and has a diameter of from about 20 μ

m to about 2 mm.

50. The method of claim 39, wherein said device further comprises a boundary structure for controlling the spreading of a dispensed first polymer layer precursor to a predetermined region of said device.

51. The method of claim 39, wherein said device further comprises a boundary structure for controlling the spreading of a dispensed second polymer layer precursor to a predetermined region of the device.

52. The method of claim 39, wherein said first and said second pads are separated by a distance of from about 10 μ

m to about 2 mm.

53. The method of claim 39, wherein said first and said second polymer layers are domed.

54. The method of claim 39, wherein said electrical property comprises current, resistance, impedance, conductivity, or a combination thereof.

55. The method of claim 54, further comprising measuring an initial current value associated with said first and said second polymer layers when said device is manufactured and wherein said threshold level is at least five times higher than said initial current value.

56. The method of claim 54, further comprising measuring an initial impedance value associated with said first and said second polymer layers when said device is manufactured, wherein said threshold level is at least five times lower than said initial impedance.

57. The method of claim 39, wherein said potential comprises a sigmoidal potential cycle, a fixed applied potential, a sequence of fixed applied potential steps, or a combination thereof.

58. The method of claim 39, wherein said potential comprises a potential cycle that is applied at a predetermined frequency in the range of about 1 Hz to about 100000 Hz.

59. The method of claim 39, further comprising inserting said device into an analyzer configured to determine whether said measured electrical property associated with said first and said second polymer layers has exceeded said threshold level associated with said device usability.

60. The method of claim 39, where said device further comprises a sensor selected from a group consisting of a pH sensor, oxygen sensor, carbon dioxide sensor, hematocrit sensor, glucose 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.

61. A method of claim 39, where said first polymer layer is printed onto said device in a first step and said second polymer layer is printed onto said first layer in a second step.

62. A method of claim 39, where said electrical response is dependent on an organic salt migrating from said second polymer layer into said first polymer layer, wherein said migration is time and temperature dependent.

63. A device having a usability threshold, comprising:

a first electrical pad;

a second electrical pad;

a first polymer layer contacting at least a portion of said first electrical pad; and

a second polymer layer contacting at least a portion of said second electrical pad and at least a portion of said first polymer layer,

wherein said first and said second polymer layers have an electrical property associated with said device usability threshold.

64. A device comprising:

a sensor;

a first polymer layer formed on a surface of said device;

a second polymer layer formed on said surface of said device;

a first electrical pad; and

a second electrical pad,

wherein;

said surface comprises said first and said second electrical pads positioned adjacent to one another and a space therebetween;

said first polymer layer covers at least a portion of said first electrical pad and a portion of said space therebetween;

said second polymer layer contacts at least a portion of said second electrical pad, a portion of said first polymer layer, and a portion of said space therebetween;

a preselected potential or potential cycle is applied to said first and said second electrical pads and an impedance or current associated with said first and said second polymer layers is measured; and

said measured impedance or current is converted to a value indicative of an average shelf life time remaining for other devices from a same manufacturing lot of said device.

65. A method of determining device usability, comprising the steps of:

providing a device comprising a first electrical pad;

a second electrical pad; and

a first polymer layer contacting at least a portion of said first electrical pad and a second polymer layer contacting at least a portion of said second electrical pad and at least a portion of said first polymer layer;

applying a potential across said first and said second electrical pads;

measuring an electrical property associated with said first and said second polymer layers; and

determining a correction factor associated with said measured electrical property; and

applying said correction factor to a signal generated by a sensor to produce a corrected signal.

66. The method of claim 65, wherein said correction factor is selected from a group consisting of an amperometric correction value, a potentiometric correction value, a coulombic correction value and a conductivity correction value.

67. The method of claim 65, wherein said sensor is selected from a group consisting of a pH sensor, an oxygen sensor, a carbon dioxide sensor, a hematocrit sensor, a glucose sensor, a lactate sensor, a creatinine sensor, a sodium sensor, a potassium sensor, a chloride sensor, a calcium sensor, a BNP sensor, a troponin sensor, a CKMB sensor, a NGAL sensor, a TSH sensor, a D-dimer sensor, a PSA sensor, a PTH sensor, a cholesterol sensor, an ALT sensor, an AST sensor, a prothrombin sensor, an APTT sensor, an ACT sensor and a galectin sensor.

68. The method of claim 65, wherein said first polymer layer comprises a polymer matrix and a plasticizer.

69. The method of claim 65, wherein said second polymer layer comprises a polymer matrix, a plasticizer, and an organic salt.

70. The method of claim 65, wherein said electrical property comprises current, resistance, impedance, conductivity, or a combination thereof.

71. The method of claim 70, further comprising measuring an initial current value associated with said first and said second polymer layers when said device is manufactured and wherein said threshold level is at least five times greater than said initial current value.

72. The method of claim 70, further comprising measuring an initial impedance value associated with said first and said second polymer layers when said device is manufactured, wherein said threshold level is at least five times lower than said initial impedance.

73. The method of claim 65, wherein said potential comprises a sigmoidal potential cycle, a fixed applied potential, a sequence of fixed applied potential steps, or a combination thereof.

74. The method of claim 65, wherein said potential comprises a potential cycle that is applied at a predetermined frequency in the range of about 1 Hz to about 100000 Hz.

75. The method of claim 65, further comprising inserting said device into an analyzer configured to determine whether said measured electrical property associated with said first and said second polymer layers has exceeded a threshold level associated with said device usability.