Adapter Assembly for Microbial Detection via Septum Penetration

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Solution Overview

Problem

Current methods for testing samples for microbial contamination face challenges in maintaining a sealed environment to prevent sample contamination and ensuring accurate detection of microbial growth, as existing systems may lead to false positives due to external contamination or leakage.

Innovation Solution

An adapter assembly is designed to penetrate the septum of a collection vessel, allowing gaseous communication with a sensor while maintaining a gas-tight seal, using a gas-permeable membrane to prevent liquid contact and ensure that gases from the headspace are delivered to the sensor without contaminating the environment, utilizing a cannula, adapter ring, sleeve, and o-ring configuration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the collection vessel is opened to access the sample, then subculturing and aliquotting become possible, but sample contamination and false positives occur

Engineering Contradiction:
Improveaccess to sampleVSAvoidsample contamination
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

A needle assembly with a beveled needle penetrates the septum to provide access to the sample interior, while a barrier membrane prevents liquid sample from contacting the exterior environment. This intermediary structure enables sample access without direct opening, maintaining sterility and preventing contamination.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

A barrier membrane (such as a polymeric film) is positioned at the septum interface to prevent liquid sample leakage while allowing needle penetration. This thin film creates a selective barrier that maintains the sealed environment during access operations.

Inventive Principle:
Principle #30Flexible shells and thin films

2Stress or pressure

If gases are allowed to escape from the collection vessel, then pressure relief is achieved, but environmental contamination and sample contamination occur

Engineering Contradiction:
Improvepressure reliefVSAvoidenvironmental contamination
Core Design Contradiction:
Stress or pressureVSObject-affected harmful factors

Solution Approach 1:

The barrier membrane provides selective permeability with different properties for different substances: it allows gases to pass through for pressure relief while blocking liquid sample from escaping. This local quality differentiation resolves the contradiction between pressure management and contamination prevention.

Inventive Principle:
Principle #3Local quality

3Reliability

If a sealed environment is maintained, then sample contamination is prevented, but access to the sample for subculturing is limited

Engineering Contradiction:
Improvesample sterilityVSAvoidsample access
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The needle assembly acts as an intermediary tool that penetrates the sealed environment through the septum, enabling sample access for subculturing and aliquotting without breaking the seal. The barrier membrane maintains sterility while the needle provides operational access.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Measurement precision

If the sensor is positioned to detect headspace gases, then microbial growth detection is enabled, but liquid sample contact with the sensor causes false readings

Engineering Contradiction:
Improvemicrobial detectionVSAvoidsensor contamination
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The barrier membrane is positioned between the liquid sample and the sensor assembly, allowing headspace gases to reach the sensor for microbial detection while preventing liquid sample from contacting the sensor. This intermediary barrier ensures accurate measurements without sensor contamination.

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

This configuration ensures accurate detection of microbial growth by preventing external contamination and ensuring that gases from the sample are transmitted to the sensor without leakage, maintaining a sterile environment and reducing the risk of false positives, thus enhancing the reliability of microbial contamination testing.

Implementation Method 1

the adapter assembly includes a gas permeable membrane configured to prevent liquid in the collection vessel from contacting the sensor

Methodology Applied
Scientific EffectGas permeability: Permeation

Data Source

PatentUS11090228B2Adapter assembly for attachment to a bottle
Publication Date: 2021.08.17 BECTON DICKINSON & CO
  • US11090228B2 patent drawing
  • US11090228B2 patent drawing
  • US11090228B2 patent drawing

AI summary

Various embodiments of the present disclosure describe systems and methods for testing samples (e.g., biological samples, environmental samples, food samples etc.) for microbial contamination. For example, some embodiments describe an adapter assembly with a means to penetrate a septum of a collection vessel and permit gaseous communication between a headspace of the collection vessel and a sensor. In some embodiments, the gases in the headspace of the collection vessel can exit the collection vessel without contaminating the environment outside the system or allowing sample contamination. In some embodiments, the adapter assembly includes a membrane configured to prevent liquid in the collection vessel from contacting the sensor. In some embodiments, the adapter assembly can be used to access media inside the collection vessel for subculturing or aliquotting for another diagnostic process such as molecular diagnostics.