Method of manufacturing a metabolic sensor
Inventors
McCarthy, Brendan • Zhang, Huashi • Boock, Robert James • Walsh, Michael Christophe
Assignees
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Publication Number
US-12369822-B2
Publication Date
2025-07-29
Expiration Date
Abstract
In some embodiments, a method of manufacturing a metabolic sensor includes assembling a working wire for a metabolic sensor and exposing the interference layer to an oxidizing agent such as a gas. The assembly comprises forming an interference layer on a substrate, the substrate having an electrically conductive surface; forming an enzyme layer on the interference layer; and forming a glucose limiting layer on the enzyme layer. The exposing is performed prior to sterilizing the working wire.
Core Innovation
A metabolic sensor is manufactured by assembling a working wire in which an interference layer is formed on a substrate having an electrically conductive surface. An enzyme layer is formed on the interference layer, and a glucose limiting layer is formed on the enzyme layer. The manufacturing process includes exposing the interference layer to a gas comprising an oxidizing agent prior to sterilizing the working wire.
The document frames the problem as preserving or improving performance of metabolic sensors after gas sterilization, with particular relevance to EtO exposure. It describes that gas sterilization can damage interference and/or enzyme layers and that the claimed approach uses oxidizing-agent exposure prior to sterilizing to protect the layers and retain or improve sensitivity and stability.
The disclosure further specifies that the interference layer can be formed by electropolymerizing selected monomer combinations such as pyrrole/phenylenediamine/aminophenol/aniline (PDA/POAP) on the substrate. The enzyme layer can be constructed by crosslinking enzymes with an immobilization matrix using a polymeric crosslinking agent to create an enzyme immobilization network, with the pre-exposure of the interference layer to an oxidizing-agent gas being performed before sterilizing the working wire.
Claims Coverage
The independent claim covers manufacturing a metabolic sensor working wire with a layered electrode structure and a pre-sterilization oxidizing-agent gas exposure of the interference layer. The claim set includes 5 inventive features across the layered working wire, oxidizing-gas exposure, electropolymerized interference layer, crosslinked enzyme immobilization network, and gas sterilization of assembled sensor and operating circuitry.
Layered working wire for metabolic sensing
Forming an interference layer on a substrate having an electrically conductive surface, forming an enzyme layer on the interference layer, and forming a glucose limiting layer on the enzyme layer.
Pre-sterilization oxidizing-gas exposure of interference layer
Exposing the interference layer to a gas comprising an oxidizing agent, wherein the exposing is performed prior to sterilizing the working wire.
Electropolymerized monomer-based interference layer
Forming an interference layer by mixing a pyrrole/phenylenediamine/aminophenol/aniline monomer or combinations with a solvent, applying it to a substrate, and electropolymerizing the solution to form a polymer on the substrate.
Crosslinked enzyme immobilization network in enzyme layer
Forming an enzyme layer where enzymes are crosslinked with an immobilization matrix using a polymeric crosslinking agent to form an enzyme immobilization network.
Gas sterilization of assembled sensor and operating circuitry in a container
Assembling a metabolic sensor with a working wire, coupling it to electronic operating circuitry, placing the circuitry and sensor in a non-sterile container, and sterilizing the container using gas sterilization.
Overall, the claim set focuses on a metabolic sensor working wire with an interference layer, enzyme layer, and glucose limiting layer, combined with exposing the interference layer to an oxidizing-agent gas before sterilizing the working wire. Dependent claims further specify the interference layer, enzyme layer, and gas sterilization of a non-sterile container holding the sensor and operating circuitry.
Stated Advantages
Retains or improves performance after gas sterilization, including sensitivity and stability.
Protects interference and/or enzyme layers from EtO/e-beam-related damage by performing oxidizing-agent exposure prior to sterilization.
Improves glucose sensor performance metrics such as sensitivity/stability post-sterilization.
Documented Applications
Gas-sterilized metabolic (electrochemical) sensors and continuous metabolic monitoring contexts, including continuous glucose monitoring (CGM), where sensor layers are configured to retain performance after ethylene oxide (EtO) sterilization.
Packaging of metabolic sensors with associated operating electronics in a sealed container that is sterilized using gas sterilization together with the sensor.
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