Endoscope Sheath Integrity Detection via Air Buffer Pressure

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Solution Overview

Problem

Current methods for decontaminating medical devices like endoscopes, particularly those with flexible sheaths, face challenges in ensuring proper connection during cleaning procedures, which can lead to ineffective sterilization due to potential leaks and compromised integrity of the sheath.

Innovation Solution

A method involving an air buffer system that pressurizes the interior space of the endoscope, with a volume matching or closely matching the interior space, to detect proper connection by measuring pressure changes, and a leak test is performed to identify any leaks, ensuring the integrity of the sheath and effective decontamination.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a small air buffer is used for pressure measurement, then the device complexity is reduced, but the measurement precision deteriorates due to inability to detect proper connection

Engineering Contradiction:
Improvedevice complexityVSAvoidmeasurement precision
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent introduces an air buffer as an intermediary component between the pressure source and the endoscope interior space. This air buffer serves as a mediator that enables accurate pressure measurement and connection detection without requiring direct complex measurement systems. The air buffer volume is specifically designed to be between 10% to 300% of the interior space volume, providing optimal conditions for detecting proper connection while maintaining measurement precision.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If pressure decay testing is performed on the sheath, then the reliability of detecting sheath integrity is improved, but false results may occur due to failed connections at the test port

Engineering Contradiction:
ImprovereliabilityVSAvoidmeasurement precision
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent performs preliminary connection testing before the main pressure decay testing. By first establishing whether the test connection is properly connected to the endoscope port, the system prevents false results during subsequent integrity testing. This preliminary action ensures that only properly connected endoscopes undergo full pressure decay testing, thereby improving the reliability of sheath integrity detection.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system incorporates feedback mechanisms where the pressure measurement from the air buffer is used to determine whether the test connection is proper. Based on this feedback, the system decides whether to proceed with leak testing or to identify a connection failure, thereby improving the overall reliability of the detection process.

Inventive Principle:
Principle #23Feedback

3Measurement precision

If the air buffer volume is made large to match the interior space, then the measurement precision is improved, but the device complexity and space requirements increase

Engineering Contradiction:
Improvemeasurement precisionVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent optimizes the air buffer volume parameter to fall within a specific range (10% to 300% of the interior space volume). This parameter optimization allows the system to achieve adequate measurement precision without requiring an excessively large air buffer. The controlled parameter range balances measurement accuracy with device complexity and space requirements.

Inventive Principle:
Principle #35Parameter changes

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

This approach ensures accurate detection of proper connection and leak testing, preventing false results and ensuring thorough decontamination of endoscopes by maintaining the integrity of the flexible sheath, thereby enhancing the effectiveness and reliability of the decontamination process.

Implementation Method 1

pressurizing an air buffer, which is connected to the endoscope part to a predetermined pressure

Methodology Applied
Scientific EffectPressure transfer: Pressure Gradient

Implementation Method 2

opening the isolation valve and measuring the pressure of the air buffer

Methodology Applied
Scientific EffectPressure measurement: Pressure Gradient

Implementation Method 3

a leak test is performed on the interior space by measuring pressure degradation therein over time

Methodology Applied
Scientific EffectPressure decay: Pressure Gradient

Data Source

PatentEP1769721B1Method of detecting integrity of test connection of endoscopes
Publication Date: 2009.01.07 ETHICON INC
  • EP1769721B1 patent drawingFigure 1
  • EP1769721B1 patent drawingFigure 2
  • EP1769721B1 patent drawingFigure 3

AI summary

A method detects proper connection of a test connection to an endoscope port which leads to an interior space beneath a flexible sheath on an endoscope. Both the interior space and an air buffer are pressurized and then isolated from each other. Pressure in the interior space is vented and the isolation is removed. After the pressure settles out the new pressure is compared with the first pressure. If it has not dropped substantially it is determined that the test connection is not properly attached and the interior space is in fact not being pressurized.