Membrane System With Sufficient Buffering Capacity
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Abstract
Electrochemical sensors for measurement of an analyte comprising an analyte sensing membrane comprising at least one salt of acetate ion, carbonate ion, bicarbonate ion, or mixtures thereof. Sensor testing methods comprising contacting an electrochemical sensor with an aqueous solution comprising at least one salt of acetate ion, carbonate ion, bicarbonate ion, or mixtures thereof and contacting the electrochemical sensor with one or more concentrations of analyte, the one or more concentrations of analyte being in the clinical concentration range of the analyte.
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Citations
57 Claims
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1-33. -33. (canceled)
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34. An electrochemical analyte sensor comprising:
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at least one electrode having an electroactive surface; an analyte sensing membrane, at least a portion of the membrane covering the electroactive surface, the membrane comprising; an optional interference layer; an enzyme layer; an optional hydrophilic polymer layer positioned (i) between the electroactive surface and the optional interference layer and/or (ii) between the optional interference layer and the enzyme layer; and at least one buffering agent associated with the analyte sensing membrane, wherein the buffering agent comprises at least one salt of acetate ion, carbonate ion, bicarbonate ion, or combinations thereof. - View Dependent Claims (35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45)
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46. An electrochemical analyte sensor comprising:
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at least one working electrode having an electroactive surface; an analyte sensing membrane comprising; a hydrophilic layer; an optional interference layer; an enzyme layer; and at least one buffering agent comprising acetate ion, carbonate ion, bicarbonate ion, or mixtures thereof, the at least one buffering agent being;
(i) deposited as a dried layer between the electroactive surface and the interference layer;
(ii) deposited as a dried layer between the interference layer and the enzyme layer;
(iii) associated with the optional hydrophilic polymer layer, the hydrophilic layer positioned (a) between the electrode surface and the interference layer and/or (b) between the interference layer and the enzyme layer;
(iv) associated with the enzyme layer;
or (v) any or all combinations of (i)-(iv);a flux-limiting layer covering the enzyme layer, the interference layer, the hydrophilic layer, and the at least one electrode; wherein the hydrophilic layer is positioned (i) between the electroactive surface and the optional interference layer or enzyme layer and/or (ii) between the optional interference layer and an enzyme layer, the hydrophilic layer comprising at least one hydrophilic polymer and excluding an enzyme. - View Dependent Claims (47, 48, 49, 50, 51, 52)
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53. An in vitro, electrochemical analyte sensor testing method, the method comprising:
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providing an electrochemical sensor; contacting the electrochemical sensor to an aqueous solution comprising a buffering agent, the buffering agent providing a signal drift at 400 mg/dL glucose or more of 10% or less over a time period of at least one hour; contacting the electrochemical sensor with one or more concentrations of analyte, the one or more concentrations of analyte being in the clinical concentration range of the analyte; and testing the electrochemical analyte sensor. - View Dependent Claims (54, 55, 56, 57)
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Specification