Dextrose Concentrate Disinfects Dialysis Disposable Sets

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Solution Overview

Problem

Current renal failure therapy systems, such as dialysis, require frequent disposable sets, leading to high costs, storage issues, and significant patient effort for setup and maintenance, especially in home-based treatments where manual processes are time-consuming and prone to contamination.

Innovation Solution

A renal failure therapy system that includes a cycler and water purifier with a control unit capable of producing dialysis fluid at the point of use, using an extended-use disposable set and a disinfecting concentrate, like dextrose, to reduce the need for daily disposables by reusing the disposable set for multiple treatments while maintaining microbiological hygiene.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If disposable sets are used for each dialysis treatment, then microbiological hygiene is maintained, but cost and storage requirements increase significantly

Engineering Contradiction:
Improvemicrobiological hygieneVSAvoiddisposable set consumption
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent changes the chemical parameters of the dialysis solution by using concentrated forms (e.g., 40% dextrose concentrate, 20% acetate concentrate) that can serve dual purposes: providing necessary dialysis components and acting as effective disinfectants. This parameter change enables the solution to fulfill both therapeutic and sterilization functions.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The dialysis concentrate is designed to perform multiple functions: it provides essential dialysis components (dextrose, acetate, calcium, magnesium) and simultaneously acts as a disinfectant for the disposable set. This multi-functionality eliminates the need for separate disinfection processes and reduces disposable consumption.

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

Solution Approach 3:

The system enables the dialysis machine and disposable set to disinfect themselves using the concentrated dialysis solution. The concentrate automatically disinfects the disposable set during the preparation and dialysis process, eliminating the need for external sterilization services or additional disinfectant supplies.

Inventive Principle:
Principle #25Self-service

2Quantity of substance

If disposable sets are reused for multiple treatments, then cost and storage space are reduced, but microbiological contamination risk increases

Engineering Contradiction:
Improvedisposable set consumptionVSAvoidmicrobiological contamination
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The patent uses concentrated dialysis solutions with high concentrations of dextrose (40%) and acetate (20%), which create osmotic and chemical conditions that are hostile to microorganism growth. These parameter changes transform the dialysis solution into an effective disinfectant that prevents contamination during set reuse.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The acetate concentrate in the dialysis solution acts as a strong antimicrobial agent that accelerates the destruction of microorganisms. The high concentration of acetate creates a harsh chemical environment that effectively kills bacteria and other contaminants, enabling safe reuse of disposable sets.

Inventive Principle:
Principle #38Strong oxidants (Accelerated oxidation)

3Adaptability or versatility

If manual dialysis procedures are performed at home, then treatment flexibility is improved, but patient effort and time consumption increase

Engineering Contradiction:
Improvetreatment flexibilityVSAvoidpatient effort
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The dialysis solution is prepared in concentrated form beforehand, eliminating the need for patients to perform complex mixing procedures during treatment. The concentrate is pre-formulated with all necessary components (dextrose, acetate, calcium, magnesium) in precise ratios, requiring only simple dilution with water during use.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system automates the disinfection process, allowing the dialysis machine to automatically flush and sterilize the disposable set using the concentrated dialysis solution. This self-service capability eliminates manual cleaning and sterilization steps, significantly reducing patient effort and time consumption.

Inventive Principle:
Principle #25Self-service

4Quantity of substance

If concentrated dialysis solutions are used for disinfection, then disposable set reuse is enabled, but solution preparation complexity increases

Engineering Contradiction:
Improvedisposable set consumptionVSAvoidsolution preparation system
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The dialysis solution is segmented into separate concentrated components (dextrose concentrate, acetate concentrate, calcium concentrate, magnesium concentrate) that can be stored independently and mixed automatically by the machine. This segmentation simplifies storage and enables automated preparation, reducing overall system complexity despite the multiple components.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses pneumatic and hydraulic systems to automatically mix the concentrated dialysis solutions with water during the dialysis process. The machine's built-in pumps and valves handle the precise dilution and mixing, eliminating manual preparation steps and reducing the complexity of user operations.

Inventive Principle:
Principle #29Pneumatics and hydraulics

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 system significantly reduces the cost, storage space, and setup time required for dialysis treatments by allowing the reuse of disposable sets for multiple treatments while ensuring effective disinfection and maintaining acceptable hygiene standards, thus improving the efficiency and convenience of renal failure therapies.

Implementation Method 1

Dextrose concentrate for the dialysate and for disinfecting... the concentrate operating as a disinfectant

Methodology Applied
Scientific EffectHypertonic environment: Osmosis

Implementation Method 2

a cycler and water purifier with a control unit capable of producing dialysis fluid at the point of use

Methodology Applied
Scientific EffectMixing: Stirring

Data Source

PatentEP3703777B1Dextrose concentrate for the dialysate and for disinfecting
Publication Date: 2024.07.03 BAXTER INT INC
  • EP3703777B1 patent drawingFigure 1
  • EP3703777B1 patent drawingFigure 2
  • EP3703777B1 patent drawingFigure 3

AI summary

A renal failure therapy system includes: (i) a dialysis fluid pumping unit including a dialysis fluid pump; (ii) a disposable set operable with the dialysis fluid pumping unit such that the dialysis fluid pump can pump dialysis fluid from the disposable set; (iii) a concentrate in fluid communication with the disposable set, wherein the concentrate is used to prepare the dialysis fluid; and (iv) a control unit operating the dialysis fluid pump, the control unit configured to cause a portion of the concentrate to fill at least a portion of the disposable set between treatments, the concentrate operating as a disinfectant allowing the disposable set to be used for multiple treatments with the same dialysis pumping unit.