Sterile Dialyzer Packaging with Integrated Oxygen Absorber

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Solution Overview

Problem

Existing packaging concepts for hollow fiber filter modules, such as dialyzers, face challenges in maintaining sterility during transport and storage due to the risk of primary package perforation, which can allow oxygen to enter and cause oxidative stress, and require additional oxygen absorbers for each module, leading to increased costs and complexity.

Innovation Solution

A sterile container design where multiple hollow fiber filter modules are packaged together with protection caps covering blood inlet and outlet openings, using a puncture-proof and flexible film to create a hermetically sealed primary package, and an integrated oxygen absorber to maintain an oxygen-free environment, reducing the risk of perforation and simplifying handling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If multiple hollow fiber filter modules are packaged together in a single primary package, then productivity and storage efficiency are improved, but the risk of perforation and loss of sterility increases

Engineering Contradiction:

Improvepackaging efficiencyVSAvoidsterility maintenance

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The primary package is divided into separate sterile compartments, each containing an individual hollow fiber filter module with its own protection caps sealing the blood compartment. This segmentation maintains sterility for each module independently while allowing multiple modules to be packaged together, resolving the contradiction between packaging efficiency and sterility maintenance.

Inventive Principle:

Principle #1Segmentation

2Reliability

If additional oxygen absorbers are added to each individual filter module, then sterility is maintained, but device complexity and manufacturing costs increase

Engineering Contradiction:

Improvesterility maintenanceVSAvoidpackaging complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

Multiple oxygen absorbers are combined into a single integrated oxygen-absorbing layer within the primary package, eliminating the need for individual oxygen absorbers in each module. This merging maintains the oxygen-free environment for all modules while significantly reducing packaging complexity and manufacturing costs.

Inventive Principle:

Principle #5Merging (Combining)

3Reliability

If a hermetically sealed primary package is used, then sterility is maintained during storage, but the package is susceptible to perforation during transport and handling

Engineering Contradiction:

Improvesterility maintenanceVSAvoidperforation resistance

Core Design Contradiction:

ReliabilityVSStrength

Solution Approach 1:

The primary package uses a composite structure combining a flexible hermetically sealed film with an integrated oxygen-absorbing layer. This composite design maintains the hermetic seal for sterility while the oxygen-absorbing layer provides additional protection and the film material is designed to resist perforation during transport and handling.

Inventive Principle:

Principle #40Composite materials

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 effectively maintains sterility by reducing the risk of primary package perforation, minimizing the need for additional oxygen absorbers, and lowering production costs while ensuring efficient sterilization and long-term storage integrity.

Implementation Method 1

oxygen present in the closed holding volume is absorbed by means of an oxygen absorber

Methodology Applied

Scientific EffectOxygen absorption: Absorption (physical)

Implementation Method 2

For sterilizing packaged hollow fiber filter modules the use of gamma rays within the scope of radiation is generally known. Gamma ray sterilization takes place in the absence of oxygen

Methodology Applied

Scientific EffectGamma radiation sterilization: Radiation

Data Source

PatentUS10722428B2Sterile container comprising sterile barrier separate from primary package and method of manufacturing sterile container

Publication Date: 2020.07.28 B BRAUN AVITUM

AI summary

A sterile container including at least one hollow fiber filter module, especially dialyzer, which is accommodated in a hermetically sealed holding volume of a primary package and includes a blood compartment delimited by a blood inlet opening and a blood outlet opening, wherein a plurality of hollow fiber filter modules is arranged in the primary package and the sterile barrier of the blood compartment of each hollow fiber filter module inside the primary package is implemented by caps which close the blood inlet opening and the blood outlet opening of each hollow fiber filter module. A method of manufacturing such sterile container is also disclosed.