Sterile Container Calibration for Medical Sensors

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Solution Overview

Problem

Medical devices, particularly sensors, face contamination risks and inaccurate calibration during temperature-specific calibration procedures due to the need for non-sterile calibration devices, which compromises sterility and precision.

Innovation Solution

A method and kit that maintain a medical device in a sterile environment by using a temperature indicator within a sterile container to accurately bring the device to a specific temperature, such as body temperature, allowing for calibration without removing the device from the container, utilizing microencapsulated liquid crystal technology for visible temperature indication.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a non-sterile calibration device is used to perform temperature-specific calibration, then the calibration can be performed, but the sterility of the medical device is compromised

Engineering Contradiction:
Improvecalibration accuracyVSAvoidcontamination risk
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

A sterile container serves as an intermediary barrier between the non-sterile calibration environment and the sterile medical device. The container allows thermal energy to pass through while blocking contamination, enabling temperature-specific calibration without direct contact between non-sterile and sterile elements. This resolves the contradiction by maintaining both calibration accuracy and sterility through the intermediary container.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces direct mechanical contact-based calibration with a non-contact thermal field-based calibration. Instead of placing the device directly in a water bath or using physical contact calibration methods, the system uses thermal energy transmission through the container wall, substituting mechanical interaction with thermal field interaction to maintain sterility while achieving accurate calibration.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Ease of operation

If the medical device is removed from sterile packaging for calibration, then calibration can be performed, but sterility is compromised

Engineering Contradiction:
Improvecalibration accessibilityVSAvoidsterility maintenance
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The sterile container acts as an intermediary that allows calibration operations to be performed on the device while it remains enclosed. The container provides a window or transparent portion that enables visual monitoring and thermal energy transmission without requiring device removal, thus maintaining sterility while preserving calibration accessibility.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The device is pre-packaged in a sterile container that is designed to withstand calibration conditions. The container is prepared in advance with features such as transparent portions and thermal conduction pathways, allowing calibration to be performed on the packaged device without requiring unpacking. This preliminary preparation maintains sterility while enabling ease of operation.

Inventive Principle:
Principle #10Preliminary action

3Object-affected harmful factors

If the calibration device is kept away from the sterile sensor to prevent contamination, then sterility is maintained, but calibration accuracy is reduced

Engineering Contradiction:
Improvecontamination preventionVSAvoidcalibration accuracy
Core Design Contradiction:
Object-affected harmful factorsVSMeasurement precision

Solution Approach 1:

The sterile container serves as a thermal intermediary that allows the calibration device to be positioned close to the sterile sensor for accurate thermal coupling while preventing contamination. The container wall provides thermal conduction pathways that enable accurate temperature transfer without requiring direct contact between non-sterile and sterile elements, thus resolving the contradiction between proximity for accuracy and distance for contamination prevention.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Ensures precise and safe calibration of medical devices at specific temperatures while maintaining sterility, reducing contamination risks and improving the accuracy and efficiency of medical procedures.

Implementation Method 1

the temperature indicator can utilize microencapsulated liquid crystal technology thereby allowing for a visible color change indicative of a temperature change

Methodology Applied
Scientific EffectLiquid crystal: Liquid Crystals

Data Source

PatentEP2016893B1Method and kit for maintaining a sterile environment during calibration of a medical device
Publication Date: 2012.05.30 CODMAN & SHURTLEFF INC
  • EP2016893B1 patent drawingFigure 1
  • EP2016893B1 patent drawingFigure 2
  • EP2016893B1 patent drawingFigure 3A

AI summary

A method for maintaining a medical device in a sterile atmosphere at a desired temperature during a calibration step is provided. The method includes packaging a medical device and temperature indicator in a sterile container such that the indicator is visible to a user. Next, heat can be applied to the container in order to stabilize the temperature of the container (as indicated by the encased temperature indicator) at room temperature. Once at room temperature, the device can be calibrated while remaining in the sterile atmosphere. A kit including such a container and a set of instructions is also provided. Like above, the container of the kit can include a sterile medical device and temperature indicator such that the device can be maintained in a sterile environment during calibration and/or zeroing. As such, the method and kit allow for increased precision and safety in performing medical procedures.