Peritoneal Dialysis Fluid Line Chemical Testing Device

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Solution Overview

Problem

Current peritoneal dialysis systems lack an efficient method for early detection of peritonitis, relying on subjective visual observations of effluent clarity, which can be ambiguous and delay diagnosis.

Innovation Solution

A chemical testing device is integrated into the peritoneal dialysis fluid line set, featuring test pads with reactive reagents that change color upon contact with leukocytes or nitrites, providing a clear visual indicator of infection as spent dialysate flows through the system, facilitating real-time diagnosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If visual observation of effluent clarity is used for infection detection, then the system remains simple and cost-effective, but the diagnosis becomes ambiguous and delayed

Engineering Contradiction:
Improveinfection detection accuracyVSAvoidtesting system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical/visual observation system with a chemical testing system. Test strips containing chemical reagents react with substances in the effluent (such as leukocytes, nitrites, or glucose) to produce visible color changes, providing objective chemical detection instead of subjective visual assessment.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces chemical reagents as intermediaries between the effluent and the detection process. These reagents specifically react with infection markers in the effluent, amplifying the detection signal and making infection presence clearly visible through color changes on the test strips.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Loss of time

If early detection of peritonitis is achieved through chemical testing, then treatment can be prompt and effective, but the device complexity and cost increase

Engineering Contradiction:
Improvediagnosis timeVSAvoidtesting device complexity
Core Design Contradiction:
Loss of timeVSDevice complexity

Solution Approach 1:

The patent employs test strips that are pre-prepared with multiple reagents applied to different sections of the strip. This preliminary preparation allows for rapid simultaneous detection of multiple infection markers (leukocytes, nitrites, glucose) without requiring sequential testing, thus reducing diagnosis time while keeping the device relatively simple.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent divides the testing function into multiple specialized test strips or sections on a single strip, each containing reagents for detecting specific infection markers. This segmentation allows parallel detection of multiple parameters, enabling comprehensive infection assessment quickly without requiring a complex multi-device system.

Inventive Principle:
Principle #1Segmentation

3Reliability

If multiple infection markers are detected simultaneously, then diagnostic reliability improves, but the test device complexity increases

Engineering Contradiction:
Improveinfection diagnosis reliabilityVSAvoidchemical testing device complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent segments the diagnostic function across multiple test strips or distinct regions on a single strip, with each segment containing reagents specific to one infection marker (leukocytes, nitrites, or glucose). This allows simultaneous detection of multiple markers while keeping each individual test region simple and well-defined.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent creates a universal testing platform where a single test strip system can detect multiple infection markers through different reagent sections. This multi-functional approach improves diagnostic reliability by assessing various infection indicators simultaneously without requiring separate specialized devices for each marker.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 chemical testing device offers a user-friendly, reliable means for early-stage diagnosis of peritonitis, reducing ambiguity and enabling prompt treatment by providing distinct color changes indicative of infection, thus benefiting patients with end-stage renal disease undergoing peritoneal dialysis.

Implementation Method 1

test pads with reactive reagents that change color upon contact with leukocytes or nitrites

Methodology Applied
Scientific EffectColor change: Chemiluminescence

Data Source

PatentEP3762062B1Peritoneal dialysis systems and related methods
Publication Date: 2024.02.28 FRESENIUS MEDICAL CARE HOLDINGS INC
  • EP3762062B1 patent drawingFigure 1
  • EP3762062B1 patent drawingFigure 2
  • EP3762062B1 patent drawingFigure 3

AI summary

A peritoneal dialysis (PD) fluid line set includes a fluid line configured to carry spent dialysate to a drain receptacle and a chemical testing device disposed along the fluid line. The chemical testing device is configured to detect a presence of a substance in the spent dialysate as the spent dialysate flows past the chemical testing device, and the chemical testing device is configured to provide a visual indicator of the presence of the substance in the spent dialysate.