Non-or minimally invasive monitoring methods

Abstract

An apparatus for sensing an analyte is described, wherein the apparatus includes an interface contact element that is used to establish an interface with a quantity of body fluid. The interface contact element is adapted to facilitate diffusion of a target analyte across the interface essentially free of net mass fluid transport. The quantity of body fluid is exposed to the interface contact element through micro-pathways. The apparatus can also include a sensing material adapted to sense the target analyte with at least one analytical method. Methods for using the apparatus in a non- or minimally invasive monitoring technique are also described. FIG. (1) illustrates a non-limiting embodiment of the apparatus used to test the principles of the invention.

Description

FIELD OF THE INVENTION The present invention relates to methods of continuous or rapid intermittent monitoring of body fluid for the presence and / or concentration of target analytes. More particularly, the invention relates to using diffusion of a target analyte from a body fluid such as interstitial fluid via a micro-pathway, and an interface contact element that is used to establish an equilibrium of analyte concentration between the body fluid and the interface contact element. The concentration of the target analyte can then be measured using a sensing material, thereby providing for continuous analyte monitoring such as continuous glucose monitoring by diabetic or hypoglycemic subjects. BACKGROUND OF THE INVENTION A number of tests are routinely performed on humans to evaluate the amount or existence of substances present in blood or other body fluids. These tests typically rely on physiological fluid samples removed from a subject, either using a syringe or by pricking the s...

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