Methods and devices for determining sensing device usability
First Claim
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 continuous polymer layer contacting at least a portion of the first and second electrical pads;
applying, by an instrument, a potential across the first and second electrical pads;
measuring, by the instrument, an electrical property associated with the continuous polymer layer;
determining, by the instrument, whether the measured electrical property associated with the continuous polymer layer has exceeded a threshold level associated with the device usability; and
determining, by the instrument, the device is valid for use when the measured electrical property associated with the continuous polymer layer does not exceed the threshold level,wherein the continuous polymer layer comprises a polymer matrix, a plasticizer and an organic salt, andwherein the continuous polymer layer comprises from 20 to 40 wt.% polymer matrix.
1 Assignment
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Accused Products
Abstract
Methods and devices for determining sensing device usability, e.g., for point of care immunoassay 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 continuous 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 continuous polymer layer; and determining whether the measured electrical property associated with the continuous polymer layer has exceeded a threshold level associated with the device usability.
35 Citations
39 Claims
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1. A method of determining device usability, comprising the steps of:
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providing a device comprising a first electrical pad;
a second electrical pad; and
a continuous polymer layer contacting at least a portion of the first and second electrical pads;applying, by an instrument, a potential across the first and second electrical pads; measuring, by the instrument, an electrical property associated with the continuous polymer layer; determining, by the instrument, whether the measured electrical property associated with the continuous polymer layer has exceeded a threshold level associated with the device usability; and determining, by the instrument, the device is valid for use when the measured electrical property associated with the continuous polymer layer does not exceed the threshold level, wherein the continuous polymer layer comprises a polymer matrix, a plasticizer and an organic salt, and wherein the continuous polymer layer comprises from 20 to 40 wt.% polymer matrix. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method of determining device usability, comprising the steps of:
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providing a device comprising a first electrical pad;
a second electrical pad; and
a continuous polymer layer contacting at least a portion of the first and second electrical pads;applying, by an instrument, a potential across the first and second electrical pads; measuring, by the instrument, an electrical property associated with the continuous polymer layer; determining, by the instrument, whether the measured electrical property associated with the continuous polymer layer has exceeded a threshold level associated with the device usability; and determining, by the instrument, the device is valid for use when the measured electrical property associated with the continuous polymer layer does not exceed the threshold level, wherein the continuous polymer layer comprises a polymer matrix, a plasticizer and an organic salt, and wherein the continuous polymer layer comprises from 0.1 to 10 wt.% of the organic salt. - View Dependent Claims (12)
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13. A method of determining device usability, comprising the steps of:
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providing a device comprising a first electrical pad;
a second electrical pad; and
a continuous polymer layer contacting at least a portion of the first and second electrical pads;applying, by an instrument, a potential across the first and second electrical pads; measuring, by the instrument, an electrical property associated with the continuous polymer layer; determining, by the instrument, whether the measured electrical property associated with the continuous polymer layer has exceeded a threshold level associated with the device usability; and determining, by the instrument, the device is valid for use when the measured electrical property associated with the continuous polymer layer does not exceed the threshold level, wherein the continuous polymer layer comprises a polymer matrix, a plasticizer and an organic salt, and wherein the continuous polymer layer is substantially circular and has a diameter of from about 20 μ
m to about 2 mm. - View Dependent Claims (14, 15, 16)
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17. A method of determining device usability, comprising the steps of:
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providing a device comprising a first electrical pad;
a second electrical pad; and
a continuous polymer layer contacting at least a portion of the first and second electrical pads;applying, by an instrument, a potential across the first and second electrical pads; measuring, by the instrument, an electrical property associated with the continuous polymer layer; determining, by the instrument, whether the measured electrical property associated with the continuous polymer layer has exceeded a threshold level associated with the device usability; and determining, by the instrument, the device is valid for use when the measured electrical property associated with the continuous polymer layer does not exceed the threshold level, wherein the continuous polymer layer comprises a polymer matrix, a plasticizer and an organic salt, wherein the first and second pads are separated by a distance of from about 10 μ
m to about 2 mm, andwherein the continuous polymer layer is domed.
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18. A method of determining device usability, comprising the steps of:
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measuring an initial current value associated with a continuous polymer layer when a device is manufactured; providing the device comprising a first electrical pad;
a second electrical pad; and
the continuous polymer layer contacting at least a portion of the first and second electrical pads;applying, by an instrument, a potential across the first and second electrical pads; measuring, by the instrument, an electrical property associated with the continuous polymer layer; determining, by the instrument, whether the measured electrical property associated with the continuous polymer layer has exceeded a threshold level associated with the device usability; and determining, by the instrument, the device is valid for use when the measured electrical property associated with the continuous polymer layer does not exceed the threshold level, wherein the electrical property comprises current, and wherein the threshold level is at least five times lower than initial current value.
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19. A method of determining device usability, comprising the steps of:
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measuring an initial impedance value associated with a continuous polymer layer when a device is manufactured; providing the device comprising a first electrical pad;
a second electrical pad; and
the continuous polymer layer contacting at least a portion of the first and second electrical pads;applying, by an instrument, a potential across the first and second electrical pads; measuring, by the instrument, an electrical property associated with the continuous polymer layer; determining, by the instrument, whether the measured electrical property associated with the continuous polymer layer has exceeded a threshold level associated with the device usability; and determining, by the instrument, the device is valid for use when the measured electrical property associated with the continuous polymer layer does not exceed the threshold level, wherein the electrical property comprises current, and wherein the threshold level is at least five times greater than the initial impedance.
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20. A device having a usability threshold, comprising
a first electrical pad, a second electrical pad, and a continuous polymer layer contacting at least a portion of the first and second electrical pads, wherein the continuous polymer layer has an electrical property associated with the device usability threshold, wherein the continuous polymer layer comprises a polymer matrix, a plasticizer and an organic salt, and wherein the continuous polymer layer comprises from 20 to 40 wt.% polymer matrix.
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24. A device having a usability threshold, comprising
a first electrical pad, a second electrical pad, and a continuous polymer layer contacting at least a portion of the first and second electrical pads, wherein the continuous polymer layer has an electrical property associated with the device usability threshold, wherein the continuous polymer layer comprises a polymer matrix, a plasticizer and an organic salt, and wherein the continuous polymer layer comprises from 0.1 to 10 wt.% of the organic salt.
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26. A device having a usability threshold, comprising
a first electrical pad, a second electrical pad, and a continuous polymer layer contacting at least a portion of the first and second electrical pads, wherein the continuous polymer layer has an electrical property associated with the device usability threshold, wherein the continuous polymer layer comprises a polymer matrix, a plasticizer and an organic salt, and wherein the continuous polymer layer is substantially circular and has a diameter of from about 20 μ - m to about 2 mm.
- View Dependent Claims (27, 28, 29)
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30. A device having a usability threshold, comprising
a first electrical pad, a second electrical pad, and a continuous polymer layer contacting at least a portion of the first and second electrical pads, wherein the continuous polymer layer has an electrical property associated with the device usability threshold, wherein the continuous polymer layer comprises a polymer matrix, a plasticizer and an organic salt, and wherein the continuous polymer layer is domed.
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33. A method of making a device having a usability threshold, comprising the steps of:
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providing a substantially planar surface comprising a first electrical pad and a second electrical pad; dispensing a polymer layer precursor onto the surface, and forming from the polymer layer precursor a continuous polymer layer contacting at least a portion of the first and second electrical pads, wherein the continuous polymer layer has an electrical property associated with the device usability threshold, wherein the continuous polymer layer comprises a polymer matrix, a plasticizer and an organic salt, and wherein the continuous polymer layer comprises from 20 to 40 wt.% polymer matrix. - View Dependent Claims (34, 35, 36)
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37. A method of determining a threshold level associated with analytical device usability, comprising the steps of:
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providing a plurality of devices, each of said devices comprising a sensor;
a first electrical pad;
a second electrical pad; and
a continuous polymer layer contacting at least a portion of the first and second electrical pads, wherein said devices have been exposed to different environmental conditions;measuring, by an instrument, an electrical property of the continuous polymer layer for each of the devices; measuring, by the instrument, a sensor signal for a control fluid for each of the devices; identifying, by the instrument, a subset of said plurality of devices that provide a signal having a predetermined acceptable precision level for said control fluid; and determining, by the instrument, the threshold level based on an initial value of the electrical property of the continuous polymer layer of a subset of said plurality of devices, wherein the continuous polymer layer comprises a polymer matrix, a plasticizer and an organic salt, and wherein the continuous polymer layer comprises from 20 to 40 wt.% polymer matrix. - View Dependent Claims (38)
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39. A device comprising a sensor and a continuous polymer layer formed on a substantially planar surface,
wherein the surface comprises two adjacent electrical contact pads and a space therebetween, wherein said continuous polymer layer covers at least a portion of the two electrical contact pads and a portion of said space therebetween, wherein a preselected potential or potential cycle is applied to the pads and the impedance or current associated with said continuous polymer layer is measured, said measured value is converted to a value indicative of the average shelf life time remaining for other devices from the same manufacturing lot, wherein the continuous polymer layer comprises a polymer matrix, a plasticizer and an organic salt, and wherein the continuous polymer layer comprises from 20 to 40 wt.% polymer matrix.
Specification