Sodium and Buffer Source Cartridges for Modular Dialysis

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Solution Overview

Problem

Current dialysis systems require large volumes of purified water, are cumbersome, and often inaccessible to patients with End Stage Renal Disease (ESRD), especially in developing regions, due to infrastructure limitations, and existing technologies for dialysate regeneration face challenges with sodium concentration control and portability.

Innovation Solution

A system that uses a controlled compliant flow path with a sodium chloride source and buffer source, such as sodium bicarbonate, to generate a physiologically compatible fluid from water, allowing for modular, portable, and efficient dialysis without the need for high volumes of purified water, using dry compositions that are hydrated within the system, and enabling frequent or continuous hemodialysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If traditional dialysis systems use large volumes of purified water, then dialysis treatment can be performed, but the system becomes cumbersome and inaccessible to patients, especially in developing regions

Engineering Contradiction:
Improvevolume of purified waterVSAvoidaccessibility to patients
Core Design Contradiction:
Quantity of substanceVSEase of operation

Solution Approach 1:

The system divides the dialysis fluid preparation into separate modules: a water purification module that produces small volumes of purified water, and separate cartridges containing dry sodium chloride and buffer sources. This segmentation allows the system to function with minimal water volumes while maintaining dialysis effectiveness.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The sodium chloride and buffer sources are prepared in advance as dry compositions in cartridges. These pre-prepared components are later combined with the small volume of purified water produced by the system, eliminating the need to transport or store large volumes of pre-mixed dialysis fluid.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If dialysis systems are designed for portability, then accessibility improves, but control over sodium concentration and fluid composition becomes more difficult

Engineering Contradiction:
ImproveportabilityVSAvoidsodium concentration control
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The system uses a controlled compliant flow path that automatically regulates the interaction between the small volume of purified water and the dry sodium chloride/buffer sources. The flow path design itself provides the control mechanism, eliminating the need for complex external pumping or metering equipment that would compromise portability.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system changes the physical state of the electrolyte and buffer sources from liquid solutions to dry compositions. This parameter change allows for more stable, compact storage while enabling precise control over the final fluid composition through controlled reconstitution with the purified water.

Inventive Principle:
Principle #35Parameter changes

3Quantity of substance

If dry sodium chloride and buffer cartridges are used, then the need for large water supplies is reduced, but the system complexity increases

Engineering Contradiction:
Improvevolume of water supplyVSAvoidsystem architecture
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The system merges the water purification function with the electrolyte/buffer delivery function in an integrated cartridge system. The controlled compliant flow path serves as a common infrastructure that manages both the liquid water flow and the dry composition delivery, reducing overall system complexity despite the added functionality.

Inventive Principle:
Principle #5Merging (Combining)

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 efficient generation of physiologically compatible fluids for dialysis, reducing the need for large water supplies, enhancing portability and accessibility, and allowing for more frequent or continuous treatment, thereby improving patient outcomes and accessibility, especially in resource-limited settings.

Implementation Method 1

using dry compositions that are hydrated within the system

Methodology Applied
Scientific EffectHydration: Mineral Hydration

Implementation Method 2

Dialysis emulates kidney function by removing waste solutes, excess electrolytes and excess fluid from a patient's blood. During dialysis, the patient's blood that contains a high concentration of waste solutes is exposed to a semi-permeable membrane in contact with a solute-deficient dialysis solution (dialysate). Solute removal and electrolyte balancing is accomplished via diffusion across the membrane.

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentEP2950843B1Sodium and buffer source cartridges for use in a modular controlled complaint flow path
Publication Date: 2017.09.20 MEDTRONIC INC
  • EP2950843B1 patent drawingFigure 1
  • EP2950843B1 patent drawingFigure 1A
  • EP2950843B1 patent drawingFigure 1B

AI summary

Systems and methods for using a sodium chloride source and a buffer source such as sodium bicarbonate in a controlled compliant flow path to generate from water a physiologically compatible fluid having a suitable level of a sodium ion and/or a buffer for use in hemodialysis, hemodiafiltration and hemofiltration. The system has a conditioning flow path that has at least a salination valve or salination pump, and at least one container has at least one solute in excess of the solubility of that solute. At least one of the solutes is a buffer source or sodium chloride. The conditioning flow path is in fluid communication with a controlled compliant flow path. The conditioning flow path can selectively meter fluid into and out of the controlled compliant flow path.