Capillary Dialyser Integrity Testing via Bubble Trap

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Existing methods for integrity testing of liquid capillary filters, such as capillardial dialysators, face challenges in accurately quantifying gas penetration through membrane leaks, particularly due to the difficulty in detecting and recording individual gas bubbles and the need for prolonged observation.

Innovation Solution

A procedure and system that involve flowing a liquid through the capillaries and a gas with higher pressure outside or inside the capillaries, with the gas penetrating through any leaks. The liquid is then guided through a bladder trap, where collected gas bubbles form a uniform volume, allowing for precise quantitative determination without long-term observation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If gas bubbles are detected individually through a sight glass during prolonged observation, then leak detection sensitivity is improved, but measurement time and operational complexity increase

Engineering Contradiction:
Improveleak detection sensitivityVSAvoidobservation time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

A bubble trap is introduced as an intermediary component between the capillary dialyzer and the detection system. The bubble trap collects gas bubbles that penetrate through membrane leaks, concentrating them in a controlled chamber where they can be easily detected and quantified. This mediator enables reliable leak detection without requiring prolonged observation of individual bubbles flowing through a sight glass.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The detection method transitions from observing individual bubbles in real-time to measuring the accumulated volume of gas in the bubble trap over a reference period. By changing the measurement parameter from temporal observation duration to volumetric accumulation, the system achieves reliable leak detection with shorter observation times and improved quantification capability.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If individual gas bubbles are monitored through a sight glass, then leak detection is possible, but quantitative determination of gas amount becomes difficult

Engineering Contradiction:
Improveleak detection capabilityVSAvoidquantitative determination accuracy
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The bubble trap serves as a mediator that collects and concentrates gas bubbles in a controlled environment. This allows the system to transition from qualitative observation of individual bubbles to quantitative measurement of total gas volume, improving both reliability of leak detection and precision of measurement.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

Multiple individual gas bubbles are merged into a single accumulated gas volume within the bubble trap. This consolidation enables straightforward quantitative measurement using standard volumetric techniques, eliminating the complexity of tracking and measuring each individual bubble separately.

Inventive Principle:
Principle #5Merging (Combining)

3Adaptability or versatility

If the inspection is performed on an intermittent conveyor with multiple stops, then processing flexibility is improved, but observation must be interrupted and individual bubbles can be overlooked

Engineering Contradiction:
Improveconveyor system flexibilityVSAvoidbubble detection completeness
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The bubble trap acts as a continuous collection device that operates independently of the conveyor's intermittent motion. Gas bubbles accumulate in the trap throughout the entire reference period regardless of conveyor stops or movements, ensuring complete detection without interruption while maintaining the flexibility of intermittent processing.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

This method enables an exact and efficient quantitative determination of gas penetration, improving the accuracy and speed of integrity testing for capillary filters, particularly those with thin membranes like capillardial dialysators.

Implementation Method 1

The gas is under a higher pressure than the fluid, allowing it to penetrate the capillaries through any leaks

Methodology Applied
Scientific EffectPressure gradient: Pressure Gradient

Implementation Method 2

The gas in the liquid forms small bubbles, which are flushed out of the capillaries by the liquid flow

Methodology Applied
Scientific EffectBuoyancy: Archimedes' Principle (Buoyancy)

Implementation Method 3

the contaminants diffuse through the membrane into the dialysis fluid due to a concentration gradient

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 4

or enter the dialysis fluid due to convective effects

Methodology Applied
Scientific EffectConvection: Convection

Implementation Method 5

the membrane is at least partially impermeable to other blood components such as blood plasma or particulate matter

Methodology Applied
Scientific EffectSemipermeable membrane filtration: Semipermeable Membrane

Data Source

PatentEP4054745B1Method and installation for testing the integrity of a capillary dialyser
Publication Date: 2025.04.16 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
  • EP4054745B1 patent drawingFigure 1
  • EP4054745B1 patent drawingFigure 2~3
  • EP4054745B1 patent drawingFigure 4

AI summary

A method is proposed for testing the integrity of a liquid capillary filter, in particular a capillary dialyser (1), constructed from a multiplicity of capillaries (15) enclosed by a membrane, said method having the steps of: allowing a liquid to flow through the inner or outer face of the capillaries (15), applying a gas to the outer or inner face of the capillaries (15), wherein the gas has a higher pressure than the liquid, and determining a quantity of the gas that passes into the liquid through leaks in the membrane. The method is characterized in that the liquid, after flowing through the liquid capillary filter (1), is conveyed through a bubble trap (30), and in that a gas volume (41) accumulating in the bubble trap (30) during a predefined or predefinable reference period is determined. An installation for testing the integrity of a liquid capillary filter (1) is also proposed.