Systems, devices, and methods for analyte monitoring

Inventors

Rao, Vivek S.

Assignees

Abbott Diabetes Care Inc

Abstract

Systems, devices and methods are provided for inserting at least a portion of an in vivo analyte sensor for sensing an analyte level in a bodily fluid of a subject. In particular, disclosed herein are various embodiments of applicators, and components thereof, designed to reduce trauma to tissue of a sensor insertion site and to increase the likelihood of a successful sensor insertion.

Core Innovation

The invention relates to an in vivo analyte monitoring system that reduces insertion trauma associated with sensor placement and decreases early signal attenuation. It provides an insertion apparatus that includes a sheath placed on a subject’s skin, a housing configured to move between a proximal position and a distal position relative to the sheath, and a device carrier that advances a sensor control device toward the subject’s skin. The system uses a guide that retracts toward a retracted position, with a sensor that includes a sharp tip portion.

A key aspect is inserting an in vivo analyte sensor with a sharp tip portion that is configured to pierce the subject’s skin without the use of a sharp or a needle. The sensor and/or guide geometry includes specially shaped sensor tips and V-shaped sharpened features that minimize skin penetration and puncture wound size, which the document links to reduced early signal attenuation. The approach includes sharpless insertion concepts such as skin tenting and potential energy associated with skin interaction.

The apparatus further defines mechanical embodiments for packaging and handling sensor insertion, including two-piece sterile packages and single-package variants, and multiple sharpless applicator configurations with housings, sheaths, carriers, and lockout or lock features. Mechanically, embodiments include a sensor tray with a sterilization lid, housings and sheaths with detent snap and lockout mechanisms, and device carrier and sharp carrier arrangements with retention and anti-rotation features.

Claims Coverage

The independent claim set coverage centers on an insertion apparatus that advances an in vivo analyte sensor with a retractable guide, where the sensor has a sharp tip portion configured to pierce skin without a sharp or needle. The remaining coverage focuses on mechanical relationships between housing movement and spring behavior, quantitative and structural constraints for the guide, and a skin contact interaction that generates a counterforce on the guide.

Overall claim coverage focuses on a mechanically staged insertion apparatus with a housing that advances sensor components toward skin and retracts a guide, combined with an in vivo analyte sensor having a sharp tip portion that pierces skin without using a sharp or needle, and further refinements defining spring/housing timing, guide structural constraints, and a skin-contact counterforce interaction.

Stated Advantages

Documented Applications