Focused Electron-Beam Sterilization of Analyte Sensor Sub-Assemblies

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Solution Overview

Problem

Existing analyte monitoring systems require separate sterilization processes for sensor and electronic components, which can damage electronics and complicate assembly, increasing the risk of user error and contamination.

Innovation Solution

A one-piece architecture for analyte monitoring systems that integrates sensor and electronic components, allowing for simultaneous sterilization using focused electron beam sterilization with a collimator to ensure sterility without damaging electronic components.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If separate sterilization processes are used for sensor and electronic components, then sterility is achieved, but device complexity and assembly difficulty increase

Engineering Contradiction:

ImprovesterilityVSAvoidassembly complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the sensor and electronic components into a single integrated unit that can be sterilized as one component. This eliminates the need for separate sterilization processes and final assembly by the user, thereby maintaining sterility while reducing assembly complexity and potential for user error.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent segments the sterilization process by using a collimator to focus the electron beam only on the sensor portion of the integrated unit, while protecting the electronic components from radiation damage. This allows simultaneous sterilization of the sensor without compromising the electronics.

Inventive Principle:

Principle #1Segmentation

2Reliability

If electron beam sterilization is used on the sensor, then sterility is achieved, but electronic components are damaged

Engineering Contradiction:

ImprovesterilityVSAvoidradiation damage to electronics

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a collimator as an intermediary component that focuses the electron beam. The collimator allows the beam to reach the sensor for sterilization while blocking or reducing the beam intensity that would damage the electronic components, thus protecting them from harmful radiation effects.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent applies local quality by directing the electron beam selectively to different regions of the integrated unit. The sensor region receives the full intensity of the electron beam for effective sterilization, while the electronic component region receives reduced or no beam exposure, preventing damage.

Inventive Principle:

Principle #3Local quality

3Reliability

If gaseous chemical sterilization is used on electronic components, then sterility is achieved, but sensor chemistry is damaged

Engineering Contradiction:

ImprovesterilityVSAvoidchemical damage to sensor

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent merges the sensor and electronic components into a single sterilizable unit, eliminating the need for gaseous chemical sterilization that would damage the sensor chemistry. The integrated design allows use of electron beam sterilization which is safe for both components when properly focused.

Inventive Principle:

Principle #5Merging (Combining)

4Reliability

If components are separated for sterilization, then appropriate sterilization methods can be used, but packaging waste and user error risk increase

Engineering Contradiction:

Improvesterilization effectivenessVSAvoidpackaging waste

Core Design Contradiction:

ReliabilityVSLoss of substance

Solution Approach 1:

The patent combines all sterilizable components into a single integrated unit that can be sterilized together in one process. This eliminates the need for multiple separate packages and sterilization cycles, reducing packaging waste while maintaining effective sterility. The integrated design also eliminates final user assembly, preventing user error.

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

Facilitates efficient, single-package assembly and reduces user error by integrating sterilization methods that protect both sensor and electronic components, ensuring sterility and reducing packaging waste.

Implementation Method 1

sterilizing the sensor and the sharp extending from the bottom of the electronics housing with radiation sterilization

Methodology Applied

Scientific EffectElectron beam sterilization: Electron Beam

Implementation Method 2

preventing radiation from the radiation sterilization from damaging the electronic components within the electronics housing

Methodology Applied

Scientific EffectRadiation shielding: Absorption (EM radiation)

Data Source

PatentUS20250325200A1Focused sterilization and sterilized sub-assemblies for analyte monitoring systems

Publication Date: 2025.10.23 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.