Dialysate Sodium Regimen for Hypotension and Overhydration Control

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Solution Overview

Problem

During hemodialysis, the rapid removal of fluid from the blood can lead to a decrease in blood pressure, and intradialytic salt administration to counteract this results in increased thirst and overhydration, necessitating larger fluid removal in subsequent sessions, creating a cycle that is difficult to manage.

Innovation Solution

A method and system for determining and adjusting the diffusive sodium balance between the blood and dialysis liquid to achieve a target sodium balance over multiple sessions, using a control device to manage the sodium concentration in the dialysis liquid and ultrafiltration volume, allowing for stepwise reduction of sodium balance and ultrafiltration volume to stabilize blood pressure and fluid balance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If fluid is rapidly removed from blood during dialysis to treat overhydration, then overhydration is reduced, but blood pressure decreases and may drop critically

Engineering Contradiction:
Improvefluid volumeVSAvoidblood pressure
Core Design Contradiction:
Quantity of substanceVSStress or pressure

Solution Approach 1:

The system performs preliminary actions by adjusting treatment parameters before critical blood pressure drops occur. It monitors blood pressure trends and proactively modifies ultrafiltration rates or dialysis liquid composition to prevent hypotension, rather than waiting for critical drops to occur

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system implements continuous feedback control by monitoring blood pressure, fluid balance, and patient symptoms in real-time. This feedback loop allows dynamic adjustment of ultrafiltration rates and dialysis parameters to maintain blood pressure within safe ranges while still achieving fluid removal goals

Inventive Principle:
Principle #23Feedback

2Stress or pressure

If salt concentration in dialysis liquid is increased to counteract blood pressure drop, then blood pressure is stabilized, but thirst increases and overhydration worsens

Engineering Contradiction:
Improveblood pressureVSAvoidfluid volume
Core Design Contradiction:
Stress or pressureVSQuantity of substance

Solution Approach 1:

The system dynamically adjusts dialysis liquid composition and ultrafiltration parameters based on real-time patient status. Rather than using fixed high salt concentrations, it modulates sodium levels and fluid removal rates adaptively to stabilize blood pressure without causing excessive thirst or overhydration

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes multiple treatment parameters simultaneously and dynamically, including ultrafiltration rate, dialysis liquid flow rate, and sodium concentration, to achieve blood pressure stabilization through coordinated parameter optimization rather than relying solely on salt administration

Inventive Principle:
Principle #35Parameter changes

3Stress or pressure

If intradialytic salt administration is used to maintain blood pressure, then blood pressure drops are counteracted, but thirst increases leading to increased liquid ingestion and overhydration

Engineering Contradiction:
Improveblood pressureVSAvoidthirst and overhydration
Core Design Contradiction:
Stress or pressureVSObject-affected harmful factors

Solution Approach 1:

The system replaces the mechanical/chemical approach of salt administration with a control-based approach. It uses automated monitoring and adjustment of ultrafiltration rates and dialysis parameters to stabilize blood pressure through physiological control rather than pharmacological or chemical intervention

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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

This approach helps stabilize blood pressure, reduces intradialytic complications, and minimizes the need for intradialytic salt administration, allowing for more controlled fluid management and reduced patient vulnerability to symptoms like blood pressure drops and convulsions.

Implementation Method 1

The blood filter comprises a blood chamber through which blood is led, and a dialysis liquid chamber, through which dialysis liquid is led. Both chambers are separated from each other by a semi-permeable membrane.

Methodology Applied
Scientific EffectSemi-permeable membrane separation: Semipermeable Membrane

Implementation Method 2

Blood and dialysis liquid are mostly guided by the counter current principle through the blood filter.

Methodology Applied
Scientific EffectCounter current flow: Convection

Implementation Method 3

In addition to the dialysate, the fluid to be discarded also comprises filtrate, which comprises water which was withdrawn from the blood in the blood filter.

Methodology Applied
Scientific EffectOsmosis: Osmosis

Implementation Method 4

This may be partially counteracted by increasing the salt concentration in the blood diffusive salt transfer in the dialyzer.

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentUS11786644B2Method and devices for determining a treatment regimen for altering the treatment parameters when dialyzing a patient
Publication Date: 2023.10.17 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
  • US11786644B2 patent drawing
  • US11786644B2 patent drawing
  • US11786644B2 patent drawing

AI summary

A method for determining a treatment regimen for altering the treatment parameters when dialyzing a patient over a plurality of treatment sessions taking place on future days includes determining a diffusive total target sodium balance; and determining a transitional treatment regimen by which the diffusive total target sodium balance is achieved over the plurality of future treatment sessions. A control device or closed-loop control device is configured to control a blood treatment apparatus using the method.