Regenerative Peritoneal Dialysis System Sterilization

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Solution Overview

Problem

Current peritoneal dialysis systems face challenges in generating and regenerating peritoneal dialysate with the required purity and sterility, leading to issues such as peritonitis, high costs, and storage requirements. Additionally, these systems often rely on pre-packaged dialysate, which can be expensive and scarce in areas with limited clean water resources.

Innovation Solution

A system and method for generating and regenerating peritoneal dialysate using a flow path that includes a sterilization module, a peritoneal dialysate regeneration module, and an integrated cycler. This system utilizes a water source, concentrate sources for solutes, and a control system to manage fluid movement and solute addition, ensuring the dialysate meets the necessary purity and sterility standards.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If pre-packaged dialysate is used, then sterility and purity are ensured, but cost and storage requirements increase

Engineering Contradiction:
ImprovesterilityVSAvoidstorage volume
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The system segments the dialysate preparation process into separate functional modules: a sterilization module (containing ultrafilter, UV light source, microbial filter, and dialyzer) that ensures sterility, and a concentrate mixing system that prepares the dialysate solution. This segmentation allows the sterilization function to be applied only when needed, rather than requiring continuous storage of large volumes of pre-packaged sterile dialysate.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system enables self-service sterilization of dialysate through the integrated sterilization module that can treat water and dialysate solutions on-demand using ultrafiltration, UV irradiation, and microbial filtration. This eliminates the need for external pre-packaged sterile dialysate products, allowing the system to generate its own sterile dialysate as needed.

Inventive Principle:
Principle #25Self-service

2Quantity of substance

If on-site dialysate preparation is implemented, then storage costs are reduced, but water purity requirements become more difficult to meet

Engineering Contradiction:
Improvestorage volumeVSAvoidwater purity
Core Design Contradiction:
Quantity of substanceVSManufacturing precision

Solution Approach 1:

The sterilization module acts as an intermediary between the water source and the dialysate delivery system. It includes multiple stages of purification: an ultrafilter for particle and endotoxin removal, a UV light source for microbial inactivation, and a microbial filter for bacterial removal. This intermediary processing chain transforms non-sterile water into sterile dialysate on-demand, meeting purity requirements without needing pre-packaged products.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If a sterilization module is integrated, then peritonitis risk is reduced, but device complexity increases

Engineering Contradiction:
Improveinfection riskVSAvoidsystem complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent merges multiple sterilization functions (ultrafiltration, UV irradiation, microbial filtration) and dialysate preparation functions (concentrate mixing, water treatment) into a single integrated system. The sterilization module is combined with the dialysate generation system, allowing simultaneous water purification, concentrate mixing, and sterilization in one unified device, thereby reducing the need for separate equipment and manual procedures.

Inventive Principle:
Principle #5Merging (Combining)

4Loss of substance

If regenerative capability is added, then fresh water consumption is reduced, but system complexity increases

Engineering Contradiction:
Improvewater consumptionVSAvoidsystem complexity
Core Design Contradiction:
Loss of substanceVSDevice complexity

Solution Approach 1:

The system recovers and reuses dialysate that would otherwise be discarded after a single use. The regenerative capability allows the system to filter and regenerate used dialysate, removing waste products and restoring it to usable quality. This recovered dialysate can be reused for subsequent treatments, significantly reducing fresh water consumption and the need for continuous supply of new dialysate bags.

Inventive Principle:
Principle #34Discarding and recovering

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 proposed system effectively regenerates and reuses peritoneal dialysate, reducing the need for fresh water and storage space, while ensuring the dialysate meets the required purity and sterility standards, thus minimizing complications such as peritonitis and lowering operational costs.

Implementation Method 1

The sterilization module can be any one or more of an ultrafilter, Ultraviolet (UV) light source, microbial filter, dialyzer, and combinations thereof

Methodology Applied
Scientific EffectUltrafiltration: Semipermeable Membrane

Implementation Method 2

The sterilization module can be any one or more of an ultrafilter, Ultraviolet (UV) light source, microbial filter, dialyzer, and combinations thereof

Methodology Applied
Scientific EffectUltraviolet irradiation: Absorption (EM radiation)

Implementation Method 3

The peritoneal dialysate regeneration module can include one or more of a sorbent cartridge, activated carbon, an ion exchange resin, a reverse osmosis module, a carbon filter, and a nanofilter

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentUS20250161547A1Regenerative peritoneal dialysis system
Publication Date: 2025.05.22 MOZARC MEDICAL US LLC
  • US20250161547A1 patent drawing
  • US20250161547A1 patent drawing
  • US20250161547A1 patent drawing

AI summary

Systems and methods of generating and regenerating peritoneal dialysate are provided. The systems and methods use a dialysate regeneration module, a sterilization module and concentrates to prepare peritoneal dialysate from used peritoneal dialysate or source water. An optional integrated cycler for direct infusion of the generated peritoneal dialysate is included. Optional dialysate storage containers are provided for storage of the peritoneal dialysate prior to use.