Multi-Chamber Bag Segmentation for Dialysis Fluid Stability

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Existing dialysis fluid preparation methods face issues with storage stability due to reactions between constituents, leading to degradation, agglomeration, and precipitation of calcium or magnesium carbonate, which results in unsuitable dialysis fluid for haemodialysis or peritoneal dialysis.

Innovation Solution

A multi-chamber bag design with separate chambers for different concentrates, allowing controlled sequential dissolution and pH management, preventing unwanted reactions and maintaining stability by separating glucose, acid, and basic components, ensuring the dialysis fluid remains suitable for use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If different concentrates (glucose, acid, basic components) are stored together in a single chamber, then the device complexity is reduced, but the storage stability deteriorates due to unwanted reactions between constituents leading to degradation, agglomeration, and precipitation

Engineering Contradiction:
Improvebag structureVSAvoidstorage stability
Core Design Contradiction:
Device complexityVSStability of the object's composition

Solution Approach 1:

The bag is divided into multiple chambers (first chamber for glucose concentrate, second chamber for acid concentrate, third chamber for basic concentrate) separated by separating devices. This segmentation prevents unwanted reactions between different concentrates during storage while maintaining a relatively simple overall bag structure.

Inventive Principle:
Principle #1Segmentation

2Ease of operation

If all concentrates are dissolved simultaneously, then the dissolution process is simplified, but the pH control deteriorates leading to undesired precipitations and degradation of concentrates

Engineering Contradiction:
Improvedissolution processVSAvoidpH control
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The dissolving device is configured to dissolve the acid concentrate and basic concentrate in a controlled sequence rather than simultaneously. The acid concentrate is dissolved first, then the basic concentrate is dissolved subsequently, allowing pH to be controlled at each stage and preventing undesired precipitations while maintaining simple operation.

Inventive Principle:
Principle #10Preliminary action

3Ease of manufacture

If the bag is designed as a disposable single-chamber bag, then the ease of manufacture and sterilization is improved, but the functionality deteriorates as it cannot prevent reactions between different concentrates

Engineering Contradiction:
Improvebag production and sterilizationVSAvoidchemical stability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The disposable bag is segmented into multiple chambers separated by separating devices, allowing different concentrates to be stored separately without compromising chemical stability. This maintains the advantages of disposable single-use design while enabling prevention of unwanted reactions between concentrates.

Inventive Principle:
Principle #1Segmentation

4Stability of the object's composition

If multiple separates bags for different concentrates are used, then the storage stability is improved, but the device complexity and ease of operation worsen due to multiple connection steps

Engineering Contradiction:
Improvestorage stabilityVSAvoidsystem integration
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

Multiple separate concentrate chambers are merged into a single integrated bag structure with internal separating devices. The dissolving device can access all chambers through a single connection point, combining the storage stability of separate compartments with the simplicity of a single bag system.

Inventive Principle:
Principle #5Merging (Combining)

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 multi-chamber bag design ensures high user-friendliness, rapid and complete dissolution of concentrates, and storage stability of the dialysis fluid, preventing calcium carbonate precipitation and maintaining a stable pH, thus providing a suitable solution for haemodialysis or peritoneal dialysis.

Implementation Method 1

a multi-chamber bag (1) which comprises a type A chamber (2), a first type B chamber (3) and a second type B chamber (3a), wherein the chambers are separated from each other by a separating device (4, 4a)

Methodology Applied
Scientific EffectPhysical separation:

Implementation Method 2

introduction of a fluid into one of the chambers (2, 3) of the multi-chamber bag (1), wherein the separating device (4, 4a) between the chambers (2, 3) of the multi-chamber bag (1) is breached by introducing the fluid, and wherein the concentrate (5) dissolves in/with the fluid

Methodology Applied
Scientific EffectDissolution: Solvation

Data Source

PatentEP3165244B1Multi-chamber bag
Publication Date: 2019.02.06 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
  • EP3165244B1 patent drawingFigure 1~2
  • EP3165244B1 patent drawingFigure 3~4
  • EP3165244B1 patent drawingFigure 5

AI summary

The present invention relates to a multi-chamber bag. In all embodiments at least two different concentrates can be included separately in powder form, liquid form or semi-liquid slurry form for dissolution in a fluid in the multi-chamber bag. The present invention also relates to the use of the multi-chamber bag in haemodialysis or peritoneal dialysis or a haemodialysis or peritoneal dialysis device, in particular as a container for a dialysis fluid in a haemodialysis or peritoneal dialysis device.