ENZYME MATRICES FOR USE WITH ETHYLENE OXIDE STERILIZATION
First Claim
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1. A method of making an analyte sensor apparatus comprising:
- disposing a working electrode, a reference electrode, and a counter electrode on a base layer;
disposing an analyte sensing layer over the working electrode, wherein;
the analyte sensing layer comprises glucose oxidase disposed within a polyvinyl alcohol polymer comprising N-methyl-4(4′
-formylstyryl)pyridinium (PVA-SbQ);
the PVA-SbQ polymer is selected for an ability to inhibit damage to glucose oxidase by ethylene oxide; and
disposing an analyte modulating layer disposed over the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of analyte therethrough;
so that an analyte sensor apparatus is made.
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Abstract
The invention pertains to analyte sensors designed to include layered compositions that provide these sensors with enhanced functional and/or material properties including, for example, resistance to damage caused by ethylene oxide during sterilization processes. Embodiments of the invention include polyvinyl alcohol N-methyl-4(4′-formylstyryl)pyridinium (SbQ) polymer materials and methods for employing such materials during the ethylene oxide sterilization of glucose sensors.
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Citations
20 Claims
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1. A method of making an analyte sensor apparatus comprising:
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disposing a working electrode, a reference electrode, and a counter electrode on a base layer; disposing an analyte sensing layer over the working electrode, wherein; the analyte sensing layer comprises glucose oxidase disposed within a polyvinyl alcohol polymer comprising N-methyl-4(4′
-formylstyryl)pyridinium (PVA-SbQ);the PVA-SbQ polymer is selected for an ability to inhibit damage to glucose oxidase by ethylene oxide; and disposing an analyte modulating layer disposed over the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of analyte therethrough; so that an analyte sensor apparatus is made. - View Dependent Claims (2, 3, 4, 5)
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6. A method of inhibiting damage to glucose oxidase caused by ethylene oxide vapor during a sterilization process, the method comprising disposing the glucose oxidase within a matrix comprising a polyvinyl alcohol polymer comprising N-methyl-4(4′
- -formylstyryl)pyridinium (PVA-SbQ), so that damage to glucose oxidase is inhibited.
- View Dependent Claims (7, 8, 9)
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10. A method of inhibiting microbial growth on an analyte sensor apparatus, the method comprising:
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exposing the analyte sensor apparatus to an ethylene oxide vapor so as to contact a microorganism present on the analyte sensor apparatus or a container in which the analyte sensor apparatus is disposed; and allowing the ethylene oxide to alkylate DNA of the microorganism, thereby inhibiting microbial growth, wherein the analyte sensor apparatus comprises; a base layer; a working electrode, a reference electrode, and a counter electrode disposed on the base layer; an analyte sensing layer disposed over the working electrode, wherein the analyte sensing layer comprises glucose oxidase disposed within a polyvinyl alcohol polymer comprising N-methyl-4(4′
-formylstyryl)pyridinium (PVA-SbQ); andan analyte modulating layer disposed over the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of analyte therethrough. - View Dependent Claims (11, 12, 13, 14)
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15. A composition of matter comprising:
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(1) analyte sensor apparatus having; a base layer; a working electrode, a reference electrode, and a counter electrode disposed on the base layer; an analyte sensing layer disposed over the working electrode, wherein the analyte sensing layer comprises glucose oxidase entrapped within; (a) a polyvinyl alcohol polymer comprising N-methyl-4(4′
-formylstyryl)pyridinium (SbQ);
or (b) a hydrophilic polyurethane;an analyte modulating layer disposed over the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of analyte therethrough; and (2)ethylene oxide vapor. - View Dependent Claims (16, 17, 18, 19, 20)
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Specification