Customized Dialysate Spikes for Patient-Specific Solute Control

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Solution Overview

Problem

Current dialysis systems lack the ability to customize dialysate solutions accurately, leading to sub-optimal treatment outcomes due to fixed concentrate amounts and inability to adjust for individual patient needs, resulting in potential life-threatening imbalances and the need for large storage of multiple formulations.

Innovation Solution

A method and system that customize dialysate by adding base concentrates with customizable spikes to achieve specific solute concentrations based on patient profiles, using a conductivity sensor to ensure accurate delivery and minimize operator error, allowing for compact and portable systems with reduced storage needs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If fixed concentrate amounts are used in standardized dialysate, then manufacturing simplicity is maintained, but adaptability to individual patient needs deteriorates

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidadaptability to patient needs
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The dialysate concentrate is segmented into modular components: a base concentrate containing standard electrolytes and separate additive concentrates containing specific solutes (glucose, acetate, etc.). These modules can be mixed in customizable ratios to create patient-specific formulations, enabling both manufacturing simplicity through standardized modules and adaptability through flexible combination.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system enables parameter changes by allowing adjustment of concentrate ratios and additive amounts based on patient-specific requirements such as glucose tolerance, acetate tolerance, and electrolyte needs. This transforms the fixed-parameter standardized dialysate into a variable-parameter customized solution while maintaining ease of manufacture through pre-formulated modules.

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If multiple dialysate formulations are stored to meet patient demand, then adaptability improves, but device complexity and storage requirements worsen

Engineering Contradiction:
Improvedialysate formulation varietyVSAvoidstorage and management complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The base concentrate serves as a universal foundation that can be combined with different additive concentrates to create multiple dialysate formulations. This multi-functional approach allows a single base concentrate to replace the need for storing multiple complete formulations, reducing storage complexity while maintaining formulation variety.

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

Solution Approach 2:

By segmenting dialysate into base concentrate and separate additive concentrates, the system reduces storage requirements from storing many complete formulations to storing one base formulation plus a limited set of additive modules. This segmentation simplifies inventory management while preserving the ability to create diverse customized formulations.

Inventive Principle:
Principle #1Segmentation

3Quantity of substance

If high dilution factors are used to reduce concentrate volume, then storage requirements decrease, but manufacturing precision deteriorates due to insufficient accuracy in metering concentrates

Engineering Contradiction:
Improveconcentrate volumeVSAvoidmetering accuracy
Core Design Contradiction:
Quantity of substanceVSManufacturing precision

Solution Approach 1:

The concentrate formulations are prepared in advance with pre-calculated concentrations that account for the required dilution factors. This preliminary action ensures that even with high dilution, the final dialysate achieves precise solute concentrations because the starting concentrate is specifically formulated to compensate for the dilution effect.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system adjusts concentrate concentration parameters to optimize the balance between dilution factor and metering accuracy. By concentrating the additive concentrates at appropriate levels, the system achieves both reduced volume requirements and sufficient precision in delivery, transforming the trade-off into a optimized solution.

Inventive Principle:
Principle #35Parameter changes

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 precise control over solute concentrations, reducing the risk of life-threatening imbalances and allowing for efficient, safe, and personalized dialysis treatments with a reduced need for multiple formulations, enhancing patient safety and treatment efficacy.

Implementation Method 1

sensing a conductivity of dialysate in the dialysate flow path downstream of the concentrate line using a sensor

Methodology Applied
Scientific EffectConductivity sensing: Conduction (electrical)

Implementation Method 2

Sorbent cartridges operate by adsorbing ions and other waste species from a fluid, such as dialysate

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentUS10583235B2Customized dialysate solution using spikes
Publication Date: 2020.03.10 MOZARC MEDICAL US LLC
  • US10583235B2 patent drawing
  • US10583235B2 patent drawing

AI summary

Systems and methods of generating a customized dialysate solution are provided. The system and methods use stock concentrates, with the addition of spikes to generate a customized dialysate solution based on the needs of the patient.