Probe Assembly for Sterile Bioreactor Sensor Insertion

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Solution Overview

Problem

There is a challenge in sterilly inserting sensors into flexible disposable bioreactor bags or tubing, and existing methods fail to facilitate the removal of sensors without damaging them, which is crucial for real-time data collection and cost-effective bioprocessing.

Innovation Solution

A probe assembly with a non-collapsible sheath that allows longitudinal movement of the sensor, combined with aseptic connectors and sterilization methods, enables the sterile insertion and removal of sensors from flexible or semi-rigid vessels and tubing, ensuring a sterile seal and preventing damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of information

If a sensor is inserted into a flexible disposable bioreactor bag or tubing, then real-time data collection is enabled, but the sensor may be damaged during removal or the bag/tubing integrity may be compromised

Engineering Contradiction:
Improvereal-time data collectionVSAvoidsensor integrity and bag/tubing integrity
Core Design Contradiction:
Loss of informationVSReliability

Solution Approach 1:

The system is divided into separate components: a reusable sensor probe and a disposable connector assembly. The connector can be sterilized and discarded with the bioreactor bag, while the expensive sensor remains intact for reuse. This segmentation resolves the contradiction by protecting the sensor from damage during removal while enabling real-time data collection.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A sterile connector assembly acts as an intermediary between the sensor and the bioreactor bag. This connector maintains sterile barriers and mechanical protection during insertion and removal operations, enabling data collection while preserving both sensor and bag integrity through the use of a dedicated interface component.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Duration of action of stationary object

If a sensor is permanently inserted into a bioreactor bag, then continuous monitoring is achieved, but the cost of sensor disposal or re-sterilization increases

Engineering Contradiction:
Improvecontinuous monitoringVSAvoidsensor cost
Core Design Contradiction:
Duration of action of stationary objectVSLoss of substance

Solution Approach 1:

By separating the expensive sensor from the disposable connector assembly, the system enables continuous monitoring through repeated use of the sensor while discarding only the low-cost connector and bioreactor bag. This resolves the economic contradiction by making the monitoring system partially reusable.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The disposable connector assembly is discarded after single use with the bioreactor bag, while the expensive sensor is recovered and reused for subsequent monitoring applications. This selective discarding and recovery strategy reduces overall costs while maintaining continuous monitoring capability.

Inventive Principle:
Principle #34Discarding and recovering

3Ease of manufacture

If a flexible bioreactor bag is used, then ease of disposal is improved, but sterile insertion and removal of sensors becomes more difficult

Engineering Contradiction:
Improveease of disposalVSAvoidsterile sensor insertion and removal
Core Design Contradiction:
Ease of manufactureVSEase of operation

Solution Approach 1:

The system separates the flexible disposable bioreactor bag from the sensor insertion mechanism by using a dedicated connector assembly. This connector provides structured ports for sterile sensor insertion while the bag itself remains simple and disposable, resolving the contradiction between ease of disposal and ease of sterile operation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A sterile connector assembly serves as an intermediary interface between the flexible bioreactor bag and the sensor. This connector provides mechanical structure for sterile insertion and removal operations while the flexible bag maintains its ease of disposal characteristics, as the connector handles all complex sterile interface requirements.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP2771060B1Probe assembly
Publication Date: 2024.05.29 GLOBAL LIFE SCIENCES SOLUTIONS USA LLC
  • EP2771060B1 patent drawingFigure 1A~1B
  • EP2771060B1 patent drawingFigure 1C~1D
  • EP2771060B1 patent drawingFigure 2A~2B

AI summary

A probe assembly for inserting a probe into a flexible or semi-rigid vessel or tubing having a distal aseptic connector for coupling to the vessel or tubing, the probe sheath comprising at least a portion that is rigid, the probe sheath extending longitudinally from the aseptic connector and having at least one inner longitudinal lumen configured to receive an elongate sensor or probe body and to permit longitudinal movement of the sensor/probe body within the probe sheath lumen, and an actuator for deploying a probe within the vessel or tubing by advancing the probe body through the aseptic connector to a position where the probe can measure at least one parameter within the vessel or tubing is disclosed herein.