Analyte Sensor, and Associated System and Method Employing a Catalytic Agent

Abstract

An analyte sensor for use in connection with a biofluid is described. The analyte sensor may comprise any suitable interface between the biofluid and a derivative of the biofluid and any suitable transducer of information concerning an analyte. At least one catalytic agent is provided in a locale or vicinity of the interface. The catalytic agent, such as a proteinaceous agent or a non-proteinaceous, organic-metal agent, is sufficient to catalyze the degradation of reactive oxygen and / or nitrogen species that may be present in the vicinity of the interface. An analyte-sensing kit and a method of sensing an analyte are also described.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of pending application no. 11 / 007,617 filed on Dec. 7, 2004, which is a continuation in part of application no. 10 / 819,498 filed Apr. 6, 2004, which is a continuation in part of application No. 10 / 775,604 filed on Feb. 9, 2004 now abandoned, the disclosure of each of which are incorporated herein by reference for all purposes, and each of which are assigned to assignee, Abbott Diabetes Care, Inc., of Alameda, Calif.FIELD OF THE INVENTION [0002] This invention generally relates to the provision of catalytic agents within the locale of an interface between a biofluid and derivatives of the biofluid, where the derivative of the biofluid contacts the sensing mechanism of an analyte sensor. The invention additionally relates to analyte sensors that make use of any of a variety of transducing mechanisms, and which may be placed internally, transcutaneously, or externally, relative to a body. BACKGROUND OF TH...

AI Technical Summary

Benefits of technology

The use of catalytic agents enhances sensor accuracy, reduces noise, and prevents spurious low-glucose incidents, leading to more reliable and consistent data that aligns with systemic glucose levels, thereby improving the overall performance and biocompatibility of in vivo analyte sensors.

Problems solved by technology

For example, the operation and performance of an in vivo enzyme-based biosensor may be complicated by high rates of analyte flux, such that the relationship between the concentration of glucose in a sample fluid and the response from the biosensor becomes non-linear.

Still other challenges, such as usage limitations, have become evident.

For example, data from studies of the recently available, transcutaneous CGMS system of Medtronic MiniMed, indicate spurious, low-glucose-reading incidents, particularly during periods of stillness, such as when a subject is asleep.

While nocturnal hypoglycemic events are indeed a clinical reality, especially in patients being aggressively treated with insulin, it has become recognized that false indications of such events are particular fallibilities of the CGMS system that complicate the interpretation of the data obtained using this system.

Spurious low-glucose-reading incidents are very problematic in the monitoring and treatment of a diabetic subject, as such incidents wrongly indicate that a euglycemic subject is hypoglycemic.

As an example, when a spurious, low-glucose reading is used as a signal to control insulin dosage, a subject may receive an improper or a reduced dose of insulin and thus be put at risk for becoming hyperglycemic.

Spurious low glucose readings can be further problematic as they may lead to incorrectly calibrated sensors, resulting in subsequent false, high glucose readings, which may reduce the credibility and usefulness of the alarm function, by way of example.

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