Infusion Bag Connector With Pierceable Membrane for Aseptic Filling

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Solution Overview

Problem

The existing production methods for infusion bags require autoclaving, which is energy and time-consuming and can reduce the quality of the contents, and do not allow for aseptic filling and closing of ports, leading to potential contamination.

Innovation Solution

An infusion bag design with a pierceable membrane in the connector port that can be sealed to maintain sterility during transport and opened only in an aseptic zone for filling, using a flexible clampable region and a self-sealing mechanism to ensure the bag remains sterile until filled, allowing for aseptic filling and closure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If autoclaving is used to sterilize the infusion bag, then the bag is sterilized, but energy consumption increases and production time is extended

Engineering Contradiction:

ImprovesterilityVSAvoidenergy consumption

Core Design Contradiction:

ReliabilityVSUse of energy by moving object

Solution Approach 1:

The infusion bag is sterilized in advance during manufacturing before being sealed with the pierceable membrane. This preliminary sterilization allows the bag to be sterile before transport and storage, eliminating the need for energy-intensive autoclaving after production while maintaining sterility until the membrane is pierced for filling.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If autoclaving is used to sterilize the infusion bag, then the bag is sterilized, but production time is extended

Engineering Contradiction:

ImprovesterilityVSAvoidproduction time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The infusion bag is sterilized in advance during manufacturing before being sealed with the pierceable membrane. This preliminary sterilization allows the bag to be sterile before transport and storage, eliminating the need for time-consuming autoclaving after production while maintaining sterility until the membrane is pierced for filling.

Inventive Principle:

Principle #10Preliminary action

3Productivity

If the infusion bag is filled before sterilization, then filling can be done, but the contents may be contaminated

Engineering Contradiction:

Improvefilling efficiencyVSAvoidcontamination

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The infusion bag is sterilized in advance during manufacturing before being sealed with the pierceable membrane. This preliminary sterilization ensures the bag is sterile before transport and storage, and the membrane remains sealed until piercing in a controlled environment, preventing contamination during filling.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The pierceable membrane acts as an intermediary barrier that maintains sterility during transport and storage. When the membrane is pierced in a controlled environment, it allows filling while maintaining the sterile barrier until the moment of piercing, thus preventing contamination.

Inventive Principle:

Principle #24Intermediary (Mediator)

4Reliability

If a pierceable membrane is added to the connector port, then aseptic filling is enabled, but device complexity increases

Engineering Contradiction:

ImprovesterilityVSAvoidconnector structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The pierceable membrane is integrated directly into the lower part of the connector port during the same molding process, merging the membrane function with the connector structure. This integration enables aseptic filling while minimizing the increase in device complexity by avoiding separate components.

Inventive Principle:

Principle #5Merging (Combining)

5Reliability

If the lower part is designed with a flexible clampable region, then secure closing is achieved, but manufacturing complexity increases

Engineering Contradiction:

Improvesealing reliabilityVSAvoidmolding complexity

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The flexible clampable region is integrated into the lower part of the connector port during the same molding process, merging the clamping function with the connector structure. This integration achieves secure closing while minimizing manufacturing complexity by avoiding separate components.

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS20250099329A1Infusion bag, and method for producing same

Publication Date: 2025.03.27 FRESENIUS KABI DEUTSCHLAND GMBH

AI summary

An infusion bag can be filled with a medical liquid. The infusion bag includes a connector having at least one port and a head piece as a lower part, and a connection region as an upper part. A sealing element is clamped between the upper part and the lower part. The lower part has a welded portion via which the lower part is connected to at least a first chamber of the infusion bag. Between the welded portion and the upper part, the lower part has a flexible region that can be clamped to form a body having shoulders and a neck. Between the sealing element and the flexible region is a pierceable membrane.