Aseptic Probe Assembly for 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 used in biopharmaceutical manufacturing, as existing methods fail to ensure a clear signal transmission and often damage the sensor, making it difficult to obtain real-time data and requiring costly sterilization processes.

Innovation Solution

A probe assembly with a distal aseptic connector and a rigid probe sheath that allows longitudinal movement of the probe body, enabling aseptic insertion and removal of sensors from flexible or semi-rigid vessels or tubing, along with methods for forming a welded flexible tubing to facilitate sensor insertion without damaging the sensor.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a sensor is inserted into a flexible bioreactor bag or tubing, then real-time data can be obtained, but the sensor may be damaged during insertion or removal

Engineering Contradiction:
Improvesensor integrityVSAvoidsensor insertion and removal
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

A rigid insertion tool with a hollow needle or tapered bore acts as an intermediary device to facilitate sensor insertion into flexible bioreactor bags or tubing. The tool provides structural support during insertion, preventing sensor damage while enabling access to the flexible container. The sensor is inserted through the rigid tool's opening, which maintains its shape and protects the sensor during the procedure.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If sterilization processes are applied to sensors for reuse, then infection risk is reduced, but sensor damage and cost increase

Engineering Contradiction:
ImprovesterilityVSAvoidsensor cost and integrity
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The system is divided into disposable and reusable components. The bioreactor bag or tubing with the sensor inserted is designed as a disposable unit that can be sterilized as a complete assembly, while the sensor itself can be protected within a sterile barrier or inserted through a sterile membrane, allowing the sensor to be reused without direct exposure to harsh sterilization conditions.

Inventive Principle:
Principle #1Segmentation

3Loss of information

If optical, electrical, or pH sensors are positioned inside flexible bags or tubing, then real-time monitoring is enabled, but signal transmission becomes difficult

Engineering Contradiction:
Improvesignal clarityVSAvoidsignal transmission system
Core Design Contradiction:
Loss of informationVSDevice complexity

Solution Approach 1:

A rigid insertion tool with a hollow needle or tapered bore acts as an intermediary device to facilitate sensor insertion into flexible bioreactor bags or tubing. The tool provides structural support during insertion, preventing sensor damage while enabling access to the flexible container. The sensor is inserted through the rigid tool's opening, which maintains its shape and protects the sensor during the procedure.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS11644349B2Probe assembly
Publication Date: 2023.05.09 GLOBAL LIFE SCIENCES SOLUTIONS USA LLC
  • US11644349B2 patent drawing
  • US11644349B2 patent drawing
  • US11644349B2 patent drawing

AI summary

A probe assembly for inserting a probe into a flexible or semi-rigid object is provided. The probe assembly includes an aseptic connector for coupling to the object, a probe sheath that extends longitudinally from the aseptic connector, and an actuator for deploying the probe within the object. The probe sheath has a plurality of concentric sheath elements and an inner longitudinal volume that is configured to permit longitudinal movement of the probe within the probe sheath. The actuator moves the probe longitudinally within the probe sheath by telescoping a first sheath element of the plurality within another sheath element of the plurality such that the probe is moved to a position sufficient to measure at least one parameter within the object.