Focused Electron-Beam Sterilization for Analyte Sensor Assemblies

Solution Overview

Problem

Existing analyte monitoring systems face challenges in sterilizing integrated sensor and electronic components without causing damage, as radiation sterilization harms electronics while gaseous chemical sterilization affects sensor chemistry, necessitating separate sterilization processes and user assembly, which introduces errors and complexity.

Innovation Solution

A one-piece architecture for analyte monitoring systems that integrates focused electron beam sterilization with a collimator to sterilize both sensor and electronic components within a single package, ensuring compatibility and eliminating the need for separate sterilization and user assembly.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If radiation sterilization is used to sterilize the sensor, then sterilization effectiveness is improved, but electronic components are damaged

Engineering Contradiction:

Improvesterilization effectivenessVSAvoiddamage to electronic components

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device is divided into two separate units: a sensor unit that can be sterilized using radiation and an adaptor unit containing electronic components that are sterilized using gaseous chemical sterilization. This segmentation allows each component to receive the most appropriate sterilization method without compromising its integrity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A barrier film is introduced as an intermediary between the radiation sterilization source and the electronic components. This barrier selectively blocks radiation from reaching the electronics while allowing the sensor to be sterilized, thus protecting sensitive components from harmful effects.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If gaseous chemical sterilization is used to sterilize electronic components, then sterilization effectiveness is improved, but sensor chemistry is damaged

Engineering Contradiction:

Improvesterilization effectivenessVSAvoiddamage to sensor chemistry

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device is divided into two separate units: a sensor unit that can be sterilized using radiation and an adaptor unit containing electronic components that are sterilized using gaseous chemical sterilization. This segmentation allows each component to receive the most appropriate sterilization method without compromising its integrity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A barrier film is introduced as an intermediary between the radiation sterilization source and the electronic components. This barrier selectively blocks radiation from reaching the electronics while allowing the sensor to be sterilized, thus protecting sensitive components from harmful effects.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If separate sterilization processes are used for sensor and electronic components, then sterilization compatibility is improved, but device complexity and user assembly requirements increase

Engineering Contradiction:

Improvesterilization compatibilityVSAvoidpackaging and assembly complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The device is divided into two separate units: a sensor unit that can be sterilized using radiation and an adaptor unit containing electronic components that are sterilized using gaseous chemical sterilization. This segmentation allows each component to receive the most appropriate sterilization method without compromising its integrity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The sensor unit and adaptor unit are designed to connect through a simple mechanical interface that requires minimal user assembly. The barrier film is integrated into the packaging structure, and the connection mechanism is designed to be intuitive and error-proof, reducing complexity despite the dual-unit design.

Inventive Principle:

Principle #5Merging (Combining)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables efficient, single-package sterilization of both sensor and electronic components, reducing packaging, fabrication steps, and user errors, while maintaining sterility and compatibility, thus enhancing system reliability and ease of use.

Implementation Method 1

sterilizing the sensor and the sharp with radiation sterilization

Methodology Applied

Scientific EffectElectron beam sterilization: Electron Beam

Implementation Method 2

a collimator positioned within the cap and defining a sterilization zone that receives the sensor and the sharp extending from the bottom of the electronics housing

Methodology Applied

Scientific EffectCollimation: Focusing

Data Source

PatentUS12408847B2Focused sterilization and sterilized sub-assemblies for analyte monitoring systems

Publication Date: 2025.09.09 ABBOTT DIABETES CARE INC

AI summary

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.