Sensor Calibration Chamber with Breakable Dividing Barrier

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Solution Overview

Problem

Invasive medical sensors require sterile calibration, which is challenging due to the need for precise handling to maintain sterility and the limitations of existing sterilization methods, such as ethylene oxide, which can degrade hydrophilic materials and require separate packaging for calibration solutions, leading to potential loss of sterility during the calibration process.

Innovation Solution

A sensor kit with a calibration chamber having two compartments separated by a breakable or removable water-impermeable dividing material, allowing for simple and quick calibration by mixing a calibration solution with a solid analyte source, maintaining sterility and enabling automated or manual calibration in a few minutes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If ethylene oxide sterilisation is used, then sterilisation is achieved without degrading the receptor and other materials, but water must be removed from hydrophilic materials prior to sterilisation and the process is complex

Engineering Contradiction:
Improvesterilisation effectivenessVSAvoidsterilisation process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The calibration chamber is divided into two separate compartments: a first compartment for holding the calibration solution and a second compartment for holding the solid analyte source. This segmentation allows independent sterilisation of each compartment and simplifies the overall sterilisation process while maintaining effectiveness.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The dividing material separating the two compartments is made breakable or removable. This extraction of the barrier allows the solid analyte source to be introduced into the calibration solution after sterilisation without requiring complex re-sterilisation procedures, simplifying the process while maintaining sterility.

Inventive Principle:
Principle #2Taking out (Extraction)

2Loss of time

If calibration is performed at the point of manufacture, then calibration is completed early, but inaccuracies occur due to ageing effects on sensor characteristics

Engineering Contradiction:
Improvetime to calibrationVSAvoidcalibration accuracy
Core Design Contradiction:
Loss of timeVSMeasurement precision

Solution Approach 1:

The calibration chamber is pre-prepared with the calibration solution and solid analyte source in separate compartments during manufacture, and the entire assembly is sterilised. This preliminary preparation allows the sensor to be calibrated quickly at the point of use without compromising accuracy, as the calibration standards are already in place and sterile.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If separate packaging for calibration solutions is used, then sterilisation is maintained, but loss of sterility occurs during the calibration process

Engineering Contradiction:
Improvesterility maintenanceVSAvoidcalibration simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The calibration solution and solid analyte source are combined in a single sterile calibration chamber with a breakable or removable dividing material. This merging eliminates the need for separate packaging and allows the calibration process to be performed while maintaining sterility, as the entire chamber remains sealed until the dividing material is broken or removed.

Inventive Principle:
Principle #5Merging (Combining)

4Ease of operation

If manual calibration steps are required, then calibration can be performed, but errors or inaccuracies occur if the process is not followed correctly

Engineering Contradiction:
Improvecalibration accessibilityVSAvoidcalibration accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The calibration chamber is designed to automatically mix the solid analyte source with the calibration solution when the dividing material is broken or removed. This self-service design eliminates complex manual steps and reduces the risk of user error, while still allowing easy access and performance of calibration.

Inventive Principle:
Principle #25Self-service

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

The solution allows for accurate and rapid calibration of invasive sensors while maintaining sterility, reducing the risk of errors and degradation of materials, and can be completed in under 10 minutes, suitable for both manual and automated processes.

Implementation Method 1

a breakable or removable section adapted to be broken or removed causing mixing of the contents of the first and second compartments

Methodology Applied
Scientific EffectPhysical barrier separation:

Implementation Method 2

causing mixing of the contents of the first and second compartments

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentEP2041562B1Sensor calibration
Publication Date: 2019.05.01 BAXTER HEALTHCARE SA
  • EP2041562B1 patent drawingFigure 1~2
  • EP2041562B1 patent drawingFigure 3a~3c
  • EP2041562B1 patent drawingFigure 4~6

AI summary

A sensor kit comprising a sensor for detecting an analyte, a sensor housing and a calibration chamber. The calibration chamber comprises a first compartment containing a first calibration solution and a second compartment containing a source of the analyte to be detected. A dividing material is located between the first and second compartments enabling them to be mixed on breakage or removal of the dividing material. Further compartment(s) containing further source(s) of the analyte may optionally be provided. Calibration can carried out by (a) taking a reading of the analyte concentration of the first calibration solution, (b) mixing the contents of the first and second compartments by breaking or removing the dividing material, and (c) taking a reading of the analyte concentration of the resulting mixture. Steps (b) and (c) can be repeated for further compartment(s) to provide further reading(s) if desired.