Inductively Heatable Cannula Sterile Connector

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Solution Overview

Problem

Current methods for connecting sterile closed systems require expensive clean room environments, increasing operational costs and time, and risk contamination due to the need for sterile conditions during piercing and connection processes.

Innovation Solution

A sterile connector with an inductively heatable cannula covered by an elastically deformable, heat-resistant plastic sheath, connected to a locking device that allows for fluid-tight connections without compromising the sterility of the closed systems, enabling connections outside of clean rooms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional piercing and connection methods are used, then connections between closed systems can be established, but expensive clean room environments are required and contamination risk increases

Engineering Contradiction:
Improvesterility maintenanceVSAvoidclean room requirement
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The cannula is pre-sterilized by induction heating before use, and the locking device is designed to maintain sterile barrier integrity throughout the connection process. The sheath is pre-positioned to cover the puncture area, eliminating the need for clean room environments during the connection operation.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

An elastically deformable sheath acts as an intermediary sterile barrier between the non-sterile environment and the closed system. The sheath maintains fluid-tight sealing while allowing the cannula to pierce through it, preventing direct contact between potentially contaminated surfaces and the sterile closed system.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If traditional piercing methods are used, then connections can be made, but operational time and costs increase due to clean room requirements

Engineering Contradiction:
Improveconnection speedVSAvoidclean room setup and operation time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The induction heating system provides self-sterilization of the cannula at the point of use, eliminating the need for pre-established clean room conditions. The system performs its own sterilization function locally, significantly reducing setup time and operational constraints.

Inventive Principle:
Principle #25Self-service

3Reliability

If the cannula is heated for sterilization, then sterility is improved, but the sheath material must withstand high temperatures without deforming

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidsheath heat resistance
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The sheath is designed as an elastically deformable membrane made of heat-resistant material that can withstand induction heating temperatures. The thin film structure allows thermal energy to pass through to sterilize the cannula while the material composition prevents the sheath itself from deforming or melting.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The sheath is constructed from composite or specially formulated heat-resistant polymer materials that combine flexibility with high temperature tolerance. These materials maintain structural integrity during induction heating while allowing the cannula to be effectively sterilized.

Inventive Principle:
Principle #40Composite materials

4Reliability

If the locking device encompasses the puncture area, then sterility is maintained, but the device structure becomes more complex

Engineering Contradiction:
Improvesterile barrier integrityVSAvoidlocking device structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The locking device is integrated with the sheath and cannula assembly, combining multiple functions into a unified structure. The locking mechanism simultaneously secures the cannula in place and maintains the sterile barrier, reducing the number of separate components needed.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The locking device performs multiple functions: it secures the cannula to the closed system, maintains the sterile barrier by encompassing the puncture area, and provides structural support. This multi-functionality reduces the need for additional separate components.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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

The solution allows for sterile connections between closed systems without the need for clean rooms, maintaining sterility and reducing operational costs by preventing contamination and ensuring regulatory compliance.

Implementation Method 1

The puncture area comprises an inductively heatable material and is encased in an elastically deformable, heat-resistant plastic sheath

Methodology Applied
Scientific EffectInductive heating: Induction Heating

Data Source

PatentEP4186543B1Method for sterile connection of two closed systems using hot sterilization
Publication Date: 2024.11.20 FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV
  • EP4186543B1 patent drawingFigure 1
  • EP4186543B1 patent drawingFigure 2
  • EP4186543B1 patent drawingFigure 3

AI summary

The present invention relates to sterile connectors for the sterile connection of a first closed system with a second closed system, methods for the sterile connection of a first closed system with a second closed system by means of a sterile connector, and devices for connecting a first closed system with a sterile connector.