Automated Effluent Sampling in Peritoneal Dialysis Systems

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Solution Overview

Problem

Current peritoneal dialysis systems require manual and time-consuming processes for patients to perform peritoneal equilibration tests and effluent sampling, which can lead to contamination, inaccurate sampling, and a heavy burden on patients and clinicians, especially due to the need for large drain bags and manual handling of samples.

Innovation Solution

An automated dialysis system that collects effluent samples automatically from either a particular drain cycle or the aggregate solution, using disposable pumping components with embedded identifiers and ratiometric pumping to ensure representative sampling, reducing the need for manual clamping and pouring, and eliminating the need for large drain bags by delivering unused fluid directly to a drain.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If manual effluent sampling is performed by patients, then patients can collect samples at home, but the process is time-consuming and requires patient awareness and manual clamping

Engineering Contradiction:
Improvemanual sampling operationVSAvoidtime required for sampling
Core Design Contradiction:
Ease of operationVSLoss of time

Solution Approach 1:

The system performs effluent sampling automatically without requiring patient intervention. The automated sampler collects effluent samples during drain cycles, eliminating the need for patients to manually clamp, pour, and transfer fluids, thereby resolving the contradiction between ease of operation and time consumption.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent replaces manual mechanical operations (clamping, pouring, transferring) with an automated sampling system that uses peristaltic pumps and automated valves to collect effluent samples, reducing both time and manual effort required.

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

2Quantity of substance

If patients pour effluent from large drain bags into sample containers, then samples can be collected, but contamination risk increases and the process becomes more complex

Engineering Contradiction:
Improveeffluent sample volumeVSAvoidcontamination risk
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The automated sampling system acts as an intermediary between the drain line and sample container, using sterile tubing and automated pumping to transfer effluent without requiring patient handling or pouring, thereby eliminating contamination risks while maintaining adequate sample volume.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system extracts the sampling function from the manual pouring process and integrates it directly into the drain line, allowing effluent to be diverted automatically into sample containers through sterile connections, thus removing the contamination hazard while preserving sample quantity.

Inventive Principle:
Principle #2Taking out (Extraction)

3Measurement precision

If automated sampling is implemented, then sampling accuracy and sterility improve, but device complexity increases

Engineering Contradiction:
Improvesampling accuracyVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The automated sampling system is integrated into the existing peritoneal dialysis cycler, allowing the same device to perform both dialysis therapy and automated effluent sampling. This multi-functionality reduces overall system complexity while maintaining high sampling accuracy and sterility through automated control.

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

Solution Approach 2:

The patent merges the sampling function with the dialysis cycler system, combining automated pumping, valve control, and sample collection into an integrated platform. This consolidation improves sampling precision through automated timing and sterility control while managing device complexity through unified system architecture.

Inventive Principle:
Principle #5Merging (Combining)

4Quantity of substance

If patients bring entire drain bags to clinics, then adequate sample volume is ensured, but the bags are heavy and the fluid is diluted with fresh dialysis solution

Engineering Contradiction:
Improvesample volumeVSAvoidsampling accuracy
Core Design Contradiction:
Quantity of substanceVSMeasurement precision

Solution Approach 1:

The automated sampling system performs preliminary sampling during the drain cycles, collecting effluent samples before they are diluted with fresh dialysis solution during priming and flushing. This ensures adequate sample volume is captured at the correct time point, maintaining sampling accuracy while eliminating the need to transport heavy drain bags.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP2318071B1Dialysis system having automated effluent sampling and peritoneal equilibration test
Publication Date: 2016.11.16 BAXTER INT INC
  • EP2318071B1 patent drawingFigure 1
  • EP2318071B1 patent drawingFigure 2
  • EP2318071B1 patent drawingFigure 3

AI summary

A dialysis system includes at least one dialysis fluid pump actuator, a disposable cassette including at least one pump chamber operable with the at least one pump actuator, the disposable cassette further including a plurality of fluid ports configured to be connected fluidly to a plurality of fluid containers, and a processor programmed to cause the at least one pump actuator to operate the at least one pumping chamber to selectively move effluent dialysis fluid to a drain container or to a sample container.