Peritoneal Dialysis Solution Testing via Filtration and Cytokine Assay

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Solution Overview

Problem

Existing methods for testing peritoneal dialysis solutions are inadequate in detecting contaminants that cause aseptic peritonitis, leading to outbreaks despite previous testing protocols.

Innovation Solution

A method combining a proinflammatory response test, specifically using cytokine detection, with a filtering step to assess the presence of contaminants in dialysis solutions by comparing the interleukin-6 response of retentate and filtrate portions at various molecular weight cutoffs, ensuring the solution is safe for use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing testing methods are used for peritoneal dialysis solutions, then the testing process is simple, but contaminants causing aseptic peritonitis are not detected

Engineering Contradiction:
Improvedetection accuracyVSAvoidtesting complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The testing method is segmented into multiple distinct steps: filtering the dialysis solution at specified molecular weight cutoffs (30 kDa, 50 kDa, 100 kDa) to separate components, then independently testing each fraction (retentate and filtrate) for proinflammatory response. This segmentation allows detection of contaminants that might be masked in the whole solution while maintaining systematic control over the complex testing process

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses an intermediary biological response system (proinflammatory cytokine measurement) to detect contaminants. Instead of directly detecting chemical contaminants, the method uses the body's inflammatory response as an intermediary indicator, where cytokines like IL-6 serve as measurable mediators that indicate the presence of harmful substances

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If a comprehensive testing method is implemented to detect all contaminants, then detection accuracy improves, but the testing time increases

Engineering Contradiction:
Improvecontaminant detection capabilityVSAvoidtesting duration
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The filtering step is performed as a preliminary action before the actual proinflammatory response testing. By pre-separating the dialysis solution into fractions based on molecular weight, the method prepares the sample in advance, allowing parallel processing of multiple fractions and reducing the overall testing time compared to sequential comprehensive analysis

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The method changes the testing parameters by using multiple molecular weight cutoffs (30 kDa, 50 kDa, 100 kDa) to create different separation conditions. This parameter variation allows comprehensive contaminant detection across different size ranges while maintaining efficient testing through standardized assay procedures for each fraction

Inventive Principle:
Principle #35Parameter changes

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 approach effectively identifies contaminants that may cause aseptic peritonitis, improving the safety of peritoneal dialysis solutions by determining their suitability based on cytokine responses, thereby reducing the risk of sterile peritonitis in patients.

Implementation Method 1

filtering a sample of the glucose polymer to obtain a retentate portion and a filtrate portion

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Implementation Method 2

measuring the proinflammatory response of the third assay... The proinflammatory response is interleukin-6

Methodology Applied
Scientific EffectCytokine detection:

Data Source

PatentEP2268830B2Peritoneal dialysis solution test method
Publication Date: 2016.06.15 BAXTER INT INC
  • EP2268830B2 patent drawingFigure 1
  • EP2268830B2 patent drawingFigure 2~3
  • EP2268830B2 patent drawingFigure 4~5

AI summary

A method of testing a glucose polymer or a glucose polymer derivative includes providing a sample of the glucose polymer or glucose polymer derivative. The sample is filtered at a specified molecular weight cutoff to obtain a retentate portion and a filtrate portion. The retentate portion is added to a first assay. The filtrate portion is added to a second assay. A reagent is added to each of the first assay and the second assay. The reagent produces a proinflammatory response. The proinflammatory response of each of the first assay and the second assay is measured. The proinflammatory response of the first assay is compared to the proinflammatory response of the second assay to determine if the glucose polymer or glucose polymer derivative is suitable for use in a patient.