Sterilized reusable wearable devices and wearable device forming methods in continuous analyte monitoring

Inventors

Prais, EugeneAvirovikj, DraganMayer, JR., Thomas A. J.Young, Cameron M.Gofman, Igor Y.

Assignees

Ascensia Diabetes Care Holdings AG

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Publication Number

US-12295745-B2

Patent

Publication Date

2025-05-13

Expiration Date


Abstract

In one or more embodiments, a continuous analyte monitoring wearable device includes a disposable base unit having a power source and an analyte sensor, and a reusable transmitter unit that includes electronic circuitry configured to bias the analyte sensor, measure current through the analyte sensor, and may even compute analyte values based on measured current through the analyte sensor. The disposable base unit is configured to couple to the reusable transmitter unit and supply electrical power to the electronic circuitry of the reusable transmitter unit for continuous analyte monitoring. Numerous other embodiments are provided.

Core Innovation

The disclosed invention is a continuous analyte monitoring wearable device that includes a base unit with a base, at least one power source, and an analyte sensor assembly, and an encapsulation extending over the base and the at least one power source to form an encapsulated base. The encapsulated base includes an attachment region configured to allow a reusable transmitter unit to be directly coupled to, and decoupled from, the encapsulated base, and when coupled to the attachment region, the reusable transmitter unit is configured to receive power from the at least one power source and connect to the analyte sensor assembly.

The encapsulated base, the at least one power source, and the analyte sensor assembly form a disposable unit that is sterilized. The base comprises a transmitter unit support location configured to receive the reusable transmitter unit, and the base comprises a base opening configured for receiving the reusable transmitter unit into the transmitter unit support location through the base opening. The base opening is provided at a base side configured to be adjacent a user's skin when in use.

A method of forming the continuous analyte monitoring wearable device includes providing a base with a power source support location, a sensor assembly support location, and a transmitter unit support location, placing the at least one power source at the power source support location, and placing a sensor assembly including an analyte sensor at the sensor assembly support location. The method provides an encapsulation layer over the power source, the sensor assembly, and a portion of the base to form a sealed, disposable unit configured to allow a transmitter unit to be attached to and detached from the transmitter unit support location at the base, and then provides the transmitter unit to the transmitter unit support location through a base opening adjacent a user's skin, followed by sterilizing the sealed disposable unit.

Claims Coverage

The document provides coverage for three independent claim groups: a continuous analyte monitoring wearable device, and two methods of forming such a device. Across these independent claims, the core inventive features include a disposable encapsulated base that is sterilized and designed for direct attachment and detachment of a reusable transmitter unit, with a base opening positioned to be adjacent a user's skin during use.

Disposable encapsulated base with attachment region for reusable transmitter

A continuous analyte monitoring wearable device comprising a base and at least one power source and an analyte sensor assembly, with an encapsulation extending over the base and the at least one power source to form an encapsulated base, the encapsulated base including an attachment region configured to allow a reusable transmitter unit to be directly coupled to, and decoupled from, the encapsulated base, wherein the reusable transmitter unit is configured to receive power from the at least one power source and to connect to the analyte sensor assembly when coupled to the attachment region, and wherein the encapsulated base, the at least one power source, and the analyte sensor assembly form a disposable unit that is sterilized.

Transmitter unit support location with skin-adjacent base opening

The device wherein the base comprises a transmitter unit support location configured to receive the reusable transmitter unit, the base comprises a base opening configured for receiving the reusable transmitter unit into the transmitter unit support location through the base opening, and the base opening is provided at a base side configured to be adjacent a user's skin when in use.

Forming a sealed disposable unit that allows transmitter attachment and detachment

A method of forming a continuous analyte monitoring wearable device comprising providing a base having a power source support location, a sensor assembly support location, and a transmitter unit support location, placing at least one power source at the power source support location, placing a sensor assembly including an analyte sensor at the sensor assembly support location, providing an encapsulation layer over at least a portion of the power source and sensor assembly and at least a portion of the base to form a sealed, disposable unit configured to allow a transmitter unit to be attached to, and detached from, the transmitter unit support location at the base, providing the transmitter unit to the transmitter unit support location at the base through a base opening provided at a base side configured to be adjacent a user's skin when in use, and sterilizing the sealed, disposable unit.

Encapsulated disposable base unit with transmitter attachment and detachment via base opening

A method of forming a wearable device configured to be used in continuous analyte monitoring comprising providing a base having a transmitter unit support location, a power source support location, and a sensor assembly support location, placing at least one power source at the power source support location, placing a sensor assembly including an analyte sensor at the sensor assembly support location, providing an encapsulation portion having an opening, placing the base within the opening of the encapsulation portion such that the base and encapsulation portion form a sealed, disposable base unit configured to allow a transmitter unit to be attached to and detached from the transmitter unit support location at the base, providing the transmitter unit to the transmitter unit support location at the base through a base opening provided at a base side configured to be adjacent a user's skin when in use, and sterilizing the sealed, disposable unit.

Across the independent claims, the primary claim coverage centers on a sterilized sealed disposable encapsulated base that includes an attachment region and a transmitter unit support location enabling direct coupling and decoupling of a reusable transmitter unit, with a base opening positioned adjacent to the user's skin during use. The method claims correspondingly cover forming the sealed disposable unit via encapsulation and then sterilizing it.

Stated Advantages

Cost reduction by reusing expensive transmitter electronics across multiple sensor and power base replacements.

Documented Applications

No documented applications found

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