Continuous analyte sensors and methods of making same

Abstract

Described here are embodiments of processes and systems for the continuous manufacturing of implantable continuous analyte sensors. In some embodiments, a method is provided for sequentially advancing an elongated conductive body through a plurality of stations, each configured to treat the elongated conductive body. In some of these embodiments, one or more of the stations is configured to coat the elongated conductive body using a meniscus coating process, whereby a solution formed of a polymer and a solvent is prepared, the solution is continuously circulated to provide a meniscus on a top portion of a vessel holding the solution, and the elongated conductive body is advanced through the meniscus. The method may also comprise the step of removing excess coating material from the elongated conductive body by advancing the elongated conductive body through a die orifice. For example, a provided elongated conductive body 510 is advanced through a pre-coating treatment station 520, through a coating station 530, through a thickness control station 540, through a drying or curing station 550, through a thickness measurement station 560, and through a post-coating treatment station 570.

Description

FIELD OF THE INVENTIONThe embodiments described herein relate generally to continuous analyte sensors and systems and methods for making these sensors.BACKGROUND OF THE INVENTIONDiabetes mellitus is a chronic disease, which occurs when the pancreas does not produce enough insulin (Type I), or when the body cannot effectively use the insulin it produces (Type II). This condition typically leads to an increased concentration of glucose in the blood (hyperglycemia), which can cause an array of physiological derangements (e.g., kidney failure, skin ulcers, or bleeding into the vitreous of the eye) associated with the deterioration of small blood vessels. Sometimes, a hypoglycemic reaction (low blood sugar) is induced by an inadvertent overdose of insulin, or after a normal dose of insulin or glucose-lowering agent accompanied by extraordinary exercise or insufficient food intake.A variety of implantable continuous electrochemical analyte sensors have been developed for continuously meas...

AI Technical Summary

Benefits of technology

Accordingly, there is a need for a process and system that will reduce production costs through labor reduction and minimize variations among the sensors produced, by providing automated, continuous manufacturing of continuous analyte sensors.

Problems solved by technology

This condition typically leads to an increased concentration of glucose in the blood (hyperglycemia), which can cause an array of physiological derangements (e.g., kidney failure, skin ulcers, or bleeding into the vitreous of the eye) associated with the deterioration of small blood vessels.

Typically, these types of sensors have been made by batch processes, which may not be suitable for large-scale, low-cost manufacturing, and which often result in batch-to-batch variations, thereby resulting in property variations among the sensors produced.

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