Enzyme matrices for use with ethylene oxide sterilization
AssigneeMedtronic MiniMed, Inc.
InventorsRajiv Shah, Qingling Yang, Robert C. Mucic, Jenn-Hann Larry Wang
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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.
Claims20
A method of sterilizing a device comprising a glucose oxidase composition, the method comprising:
- disposing the device in a chamber;
- introducing ethylene oxide vapor into the chamber;
- wherein:
- the glucose oxidase is disposed within a composition comprising a polyvinyl alcohol polymer comprising N-methyl-4(4′-formylstyryl)pyridinium (PVA-SbQ);
- and
- amounts of PVA-SbQ in the composition are selected to be sufficient to inhibit ethylene oxide damage to the glucose oxidase in the composition;
- and
- performing an ethylene oxide vapor sterilization process;
- so that the device comprising a glucose oxidase composition is sterilized.
A method of inhibiting microbial growth on an analyte sensor apparatus, the method comprising:
- 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);
- and
- amounts of PVA-SbQ in the analyte sensing layer are selected to be sufficient to inhibit ethylene oxide damage to the glucose oxidase in the analyte sensing layer;
- and
- an analyte modulating layer disposed over the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of analyte therethrough.
Dependencies are inferred from the claim text.