Medical Instrument Suite Sterilization for Sensor-Electronics Isolation

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Solution Overview

Problem

Existing sterilization methods for medical instrument suites, such as electron beam and ethylene oxide sterilization, can damage electronic devices or affect the functionality of analyte sensors, and require additional assembly steps, complicating user usage.

Innovation Solution

A sterilization method for a medical instrument suite that includes placing the analyte sensor's sensing portion in a sealed accommodating chamber, irradiating with an electron beam to sterilize it, assembling the electronic device, and then sealingly assembling the cartridges, ensuring the electronic device is not affected by the electron beam, and optionally using chemical gas for additional sterilization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If electron beam sterilization is used to sterilize the analyte sensor, then sterilization effectiveness is improved, but the electronic device is damaged and its normal function is affected

Engineering Contradiction:

Improvesterilization effectivenessVSAvoiddamage to electronic device

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent divides the sterilization process into separate stages: the sensing portion is sterilized by electron beam irradiation while housed in a protective container, and the electronic device is sterilized separately using chemical gas sterilization. This segmentation allows each component to receive the most suitable sterilization method without exposing sensitive components to harmful radiation.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent introduces a protective container as an intermediary structure that houses the sensing portion during electron beam sterilization. This container shields the sensing portion from direct electron beam damage while allowing sterilization to occur, and is later removed or discarded after sterilization completes.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If ethylene oxide sterilization is used to sterilize the electronic device, then sterilization effectiveness is improved, but the activity of chemicals in the sensor is affected

Engineering Contradiction:

Improvesterilization effectivenessVSAvoidaffecting sensor chemical activity

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent separates the sterilization of the electronic device from the sensing portion, allowing the electronic device to be exposed to ethylene oxide chemical gas sterilization while the sensing portion with its sensitive chemicals is protected in a separate container that prevents chemical gas penetration.

Inventive Principle:

Principle #1Segmentation

3Reliability

If separate sterilization of sensor and electronic device is performed, then sterilization effectiveness is improved, but additional assembly is required resulting in user inconvenience

Engineering Contradiction:

Improvesterilization effectivenessVSAvoiduser convenience

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent combines the separately sterilized sensing portion and electronic device into a single integrated medical instrument suite that is pre-assembled and ready for use. The protective container is designed to be discarded or automatically disposed of after use, so users do not need to perform additional assembly steps.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent employs a disposable protective container that is used during sterilization and then discarded. This eliminates the need for complex reusable shielding structures and simplifies the final assembly process for users, as the container and its contents are designed for single-use.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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

Effectively sterilizes the analyte sensor without damaging the electronic device, simplifies assembly, and ensures user convenience by eliminating the need for additional assembly steps.

Implementation Method 1

A commonly used sterilization method, such as electron beam sterilization, may be used to terminally sterilize the sensor

Methodology Applied

Scientific EffectElectron beam sterilization: Electron Beam

Data Source

PatentUS20250387525A1Sterilization method for medical instrument suite

Publication Date: 2025.12.25 SHENZHEN SISENSING TECH CO LTD

AI summary

Some embodiments of the disclosure provide a sterilization method for a medical instrument suite. In some examples, the medical instrument suite includes an analyte sensor, an electronic device, a lower cartridge having an accommodating chamber, and an upper cartridge sealingly assembled with the lower cartridge. The analyte sensor has a sensing portion that may react with an analyte to generate a sensing signal, and a connecting portion electrically connected to the sensing portion. The electronic device is configured to be able to couple with the connecting portion and receive the sensing signal generated by the sensing portion. The sterilization method includes placing the sensing portion of the analyte sensor in the accommodating chamber of the lower cartridge, and the accommodating chamber is sealed in such a manner that the sensing portion is sealed.