Focused sterilization and sterilized sub-assemblies for analyte monitoring systems
Inventors
Thomas, Christopher A. • Pace, Louis • DiPalma, Vincent M. • Rao, Vivek S. • Mitchell, Steven T. • Robinson, Peter G. • Simmons, Matthew • MEISSNER, Jörn
Assignees
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Publication Number
US-12408847-B2
Publication Date
2025-09-09
Expiration Date
Abstract
A system includes a sensor applicator, a sensor control device arranged within the sensor applicator and including an electronics housing and a sensor extending from a bottom of the electronics housing, and a cap coupled to one of the sensor applicator and the sensor control device, wherein the cap is removable prior to deploying the sensor control device from the sensor applicator.
Core Innovation
The invention provides an assembly for delivery of an analyte sensor that separates sensor control device structures from an applicator while maintaining sealed interfaces. The sensor control device includes an electronics housing with a shell, a mount secured to the shell to define an interior space, and apertures that align a first aperture in the shell with a second aperture in the mount. A circuit board is disposed within the interior space and includes a plurality of electronics modules, supporting an analyte sensor that has an in vivo portion extending through the aligned apertures and an ex vivo portion within the interior space.
To control engagement and sealing through the housing apertures, the invention uses a sharp hub adapted for engagement with the sensor control device. The sharp hub includes a sharp and a mating member, where the mating member is configured to extend through the first and second apertures and distally from an underside of the mount. A sensor cap includes an inner chamber that receives at least a portion of the in vivo portion, and the first end of the sensor cap is removably coupled to the mating member to seal the inner chamber.
Delivery is completed by an applicator for delivery of the analyte sensor, where the applicator includes a housing with a sensor carrier configured to secure the sensor control device within an interior of the applicator. An applicator cap is removably coupled to the housing to seal the interior of the applicator, and the applicator cap mates with an engagement feature on the second end of the sensor cap when the applicator cap is coupled to the housing. The sensor cap detaches from the mating member and remains mated with the applicator cap when the applicator cap is removed from the housing.
Claims Coverage
The consolidated content includes two independent claims. The claim coverage centers on an analyte sensor delivery assembly with aligned apertures, a circuit board, a sharp hub with a mating member, a removably sealed sensor cap, and an applicator cap that retains the sensor cap upon removal, together with a corresponding method of assembling and delivering the analyte sensor using the same structural mating and sealing arrangement.
Integrated analyte sensor delivery assembly with aligned apertures and circuit board
An assembly for delivery of an analyte sensor comprising a sensor control device including an electronics housing having a shell with a first aperture and a mount secured to the shell to define an interior space, the mount having a second aperture aligned with the first aperture; a circuit board disposed within the interior space including a plurality of electronics modules; and an analyte sensor including an in vivo portion extending through the second aperture and configured to measure an analyte level in a bodily fluid, and an ex vivo portion within the interior space including a plurality of electrical contacts coupled with the circuit board.
Sharp hub engagement through aligned apertures
A sharp hub adapted for engagement with the sensor control device including a sharp and a mating member, the mating member configured to extend through the first and second aperture and distally from an underside of the mount.
Removably sealed sensor cap detaches from mating member
A sensor cap having a first end, a second end, and an inner chamber, wherein the inner chamber receives at least a portion of the in vivo portion of the analyte sensor and wherein the first end is removably coupled to the mating member to seal the inner chamber.
Applicator cap retention of sensor cap upon applicator removal
An applicator including a housing having a sensor carrier configured to secure the sensor control device within an interior of the applicator; and an applicator cap removably coupled to the housing to seal the interior of the applicator, wherein the applicator cap mates with an engagement feature on the second end of the sensor cap when applicator cap is coupled to the housing, and wherein the sensor cap detaches from the mating member and remains mated with the applicator cap when applicator cap is removed from the housing.
Method of assembling and delivering analyte sensor with mating sensor cap and applicator cap
Providing a sensor control device including an electronics housing with aligned first and second apertures, a circuit board disposed within the interior space and including a plurality of electronics modules, an analyte sensor with an in vivo portion extending through the second aperture and configured to measure an analyte level in a bodily fluid, and an ex vivo portion within the interior space including a plurality of electrical contacts coupled with the circuit board; providing a sharp hub with a mating member extending through the first and second aperture and distally from an underside of the mount; providing a sensor cap with an inner chamber receiving at least a portion of the in vivo portion and removably sealing the inner chamber by removably coupling the first end to the mating member; providing an applicator including a housing with a sensor carrier securing the sensor control device within an interior; and removably coupling an applicator cap to the housing so the applicator cap mates with an engagement feature on the second end of the sensor cap when coupled to the housing, wherein the sensor cap detaches from the mating member and remains mated with the applicator cap when the applicator cap is removed from the housing.
Across the independent claims, the coverage is concentrated on an analyte sensor delivery assembly that integrates an electronics housing and circuit board with in vivo and ex vivo sensor portions through aligned apertures, uses a sharp hub with a mating member extending through those apertures, and relies on a removable sensor cap sealed to the mating member. The claims further require an applicator cap that mates with the sensor cap and ensures the sensor cap detaches from the mating member while remaining mated to the applicator cap when the applicator cap is removed.
Stated Advantages
No explicit advantages are described in the patent.
Documented Applications
No explicit applications are described in the patent.
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