Dialysis Fluid Preparation Circuit for Sterile Point-of-Care Mixing

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Solution Overview

Problem

Existing peritoneal dialysis systems require pre-packaged dialysis fluid bags, limiting flexibility and increasing costs, while existing point-of-care (POC) systems lack automation and compatibility with various dialysis cycles.

Innovation Solution

A system for preparing dialysis fluid at the point of care using a daily sterile disposable fluid circuit and long-term concentrate containers, ensuring compatibility with any dialysis cycler without modification, and incorporating automated mixing and quality control to ensure accurate medicament preparation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If pre-packaged dialysis fluid bags are used, then sterility and ease of use are ensured, but flexibility and cost-effectiveness are reduced

Engineering Contradiction:
ImprovesterilityVSAvoidflexibility
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The system divides the dialysis fluid preparation into separate sterile components (concentrate containers and water source) that are combined at the point of care. The fluid circuit is segmented into disposable sterile portions and reusable non-sterile portions, allowing sterility to be maintained while enabling flexibility in fluid preparation and cycler compatibility.

Inventive Principle:
Principle #1Segmentation

2Reliability

If pre-packaged dialysis fluid bags are used, then sterility is ensured, but cost and waste increase

Engineering Contradiction:
ImprovesterilityVSAvoidwaste
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The system changes the concentration parameter of the dialysis fluid, using concentrated formulations that are diluted at the point of care. This allows smaller, less wasteful container sizes while maintaining the required sterility, and enables more flexible dosing and preparation quantities to reduce waste.

Inventive Principle:
Principle #35Parameter changes

3Manufacturing precision

If automated mixing and quality control are implemented, then manufacturing precision is improved, but device complexity increases

Engineering Contradiction:
Improveaccurate medicament preparationVSAvoidsystem complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The system incorporates automated self-service features including automated mixing of concentrates, integrated quality control sensors that automatically monitor fluid parameters, and self-regulating delivery mechanisms. This automation achieves high manufacturing precision while the modular design keeps operational complexity manageable for end users.

Inventive Principle:
Principle #25Self-service

4Adaptability or versatility

If a system prepares medical fluid without requiring cycler customization, then adaptability is improved, but integration challenges increase

Engineering Contradiction:
Improvecompatibility with any dialysis cyclerVSAvoidintegration complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The fluid preparation system is designed with universal interfaces and standardized connection protocols that are compatible with multiple cycler types. The system performs multiple functions (concentrate storage, water mixing, fluid preparation, quality control, and delivery) through integrated components that can interface with various external cyclers without requiring custom modifications.

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

Enables safe, automated, and cost-effective preparation of dialysis fluid at the POC, ensuring compatibility with various dialysis cycles and reducing waste by using disposable components.

Implementation Method 1

Osmotic exchange with the patient's blood occurs across the peritoneal membrane, removing urea and other toxins and excess water from the blood

Methodology Applied
Scientific EffectOsmotic exchange: Osmosis

Implementation Method 2

The removal of excess water results in a higher volume of fluid being removed from the patient than is infused. The net excess is called ultrafiltrate, and the process of removal is called ultrafiltration

Methodology Applied
Scientific EffectUltrafiltration: Reverse Osmosis

Data Source

PatentUS20250345502A1Medicament Preparation Devices, Methods, and Systems
Publication Date: 2025.11.13 NXSTAGE MEDICAL INC
  • US20250345502A1 patent drawing
  • US20250345502A1 patent drawing
  • US20250345502A1 patent drawing

AI summary

A system for preparing a medicament for use by a medicament user includes a proportioning machine with a controller and pumping and clamping actuators to engage a fluid circuit having pumping and clamping portions that engage with respective actuators of the proportioning machine. The fluid circuit includes a mixing container that is initially empty and later filled with a concentrated medicament from a concentrate container. The proportioning machine is configured to receive purified water and to mix it with the concentrated medicament to produce a medicament and to output the medicament to a medicament consumer in such a way that to the medicament consumer the medicament appears to be provided from a bag of medicament.