Delayed Hemodiafiltration Control for Dialyzer Membrane Protection

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Solution Overview

Problem

Current extracorporeal blood treatment devices face challenges such as hemoconcentration, clotting, and secondary membrane formation due to suboptimal blood flow and filtration rates, leading to reduced therapeutic effectiveness and increased risk of dialyzer blockage, with limited automated error correction and inadequate consideration of secondary membrane formation.

Innovation Solution

A device for extracorporeal blood treatment that implements a delayed start of hemodiafiltration with postdilution, featuring constant size control of substitution flow and automatic adjustment of therapy parameters to ensure maximum dialyzer performance, thereby reducing stress on the secondary membrane and preventing dialyzer blockage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If hemodiafiltration treatment starts immediately with high blood flow to achieve predetermined blood flow quickly, then therapy begins promptly, but hemoconcentration and secondary membrane formation occur reducing filtration performance

Engineering Contradiction:
Improveblood flow rateVSAvoidfiltration performance
Core Design Contradiction:
SpeedVSReliability

Solution Approach 1:

The system performs preliminary hemodialysis treatment for a predetermined period before transitioning to hemodiafiltration. This preliminary action allows the secondary membrane to form naturally during initial hemodialysis, and then the system switches to hemodiafiltration mode with appropriate substitution fluid infusion, avoiding the harmful effects of immediate high-flow hemodiafiltration while still achieving the desired therapeutic outcome.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The treatment is divided into distinct periodic phases: an initial hemodialysis phase followed by a hemodiafiltration phase. During the hemodialysis phase, the system operates without substitution fluid infusion to allow membrane stabilization. After the predetermined period, it transitions to the hemodiafiltration phase where substitution fluid is infused at controlled rates, creating a periodic treatment structure that optimizes both safety and effectiveness.

Inventive Principle:
Principle #19Periodic action

2Productivity

If substitution flow rate is increased to maintain maximum dialyzer performance, then therapeutic effectiveness is maximized, but dialyzer blockage risk increases due to secondary membrane stress

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoiddialyzer blockage risk
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The system allows the secondary membrane to form and stabilize during the preliminary hemodialysis phase before exposing it to the mechanical stress of high-rate substitution flow. This preliminary conditioning of the membrane reduces its susceptibility to blockage during subsequent hemodiafiltration treatment, enabling higher substitution flow rates to be used safely.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The predetermined delay period during hemodialysis acts as a cushioning period that protects the dialyzer membrane from the harmful effects of immediate high-rate substitution flow. By allowing the membrane to adapt and stabilize first, the system cushions against the shock that would otherwise cause secondary membrane formation and subsequent blockage, enabling safer and more effective treatment.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Reliability

If blood flow is reduced temporarily due to problematic access, then patient safety is maintained, but therapy effectiveness decreases and requires doctor consultation

Engineering Contradiction:
Improvepatient safetyVSAvoidtherapy effectiveness
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The system dynamically adjusts treatment parameters based on real-time conditions. When blood flow is reduced due to access problems, the control unit automatically adapts the substitution flow rate and treatment timing to maintain safety while minimizing impact on therapy effectiveness. This dynamic adaptation eliminates the need for immediate doctor consultation in many cases.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The control unit automatically changes treatment parameters (substitution flow rate, treatment duration, transition timing) in response to reduced blood flow conditions. By dynamically adjusting these parameters, the system maintains patient safety while preserving as much therapeutic effectiveness as possible under the constrained conditions, without requiring manual intervention.

Inventive Principle:
Principle #35Parameter changes

4Reliability

If automated delayed start control is implemented to prevent secondary membrane formation, then dialyzer performance is optimized, but device complexity increases

Engineering Contradiction:
Improvedialyzer performanceVSAvoidcontrol system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The control unit automatically manages the entire delayed start sequence without requiring complex external control systems. It autonomously timing the preliminary hemodialysis phase, calculating the optimal transition point to hemodiafiltration, and adjusting substitution flow rates based on pre-programmed algorithms and real-time sensor data. This self-service capability achieves optimized dialyzer performance while keeping the control system relatively simple.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system incorporates feedback mechanisms where the control unit continuously monitors treatment parameters (blood flow rate, substitution flow rate, pressure differentials) and automatically adjusts operations based on this feedback. This closed-loop control achieves optimized dialyzer performance through automated adaptation to actual treatment conditions without requiring overly complex external control systems.

Inventive Principle:
Principle #23Feedback

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 solution ensures continuous and safe blood treatment by automatically managing blood flow and substitution rates, minimizing the risk of dialyzer blockage and maintaining maximum therapeutic effectiveness without requiring extensive user calculations or immediate medical intervention.

Implementation Method 1

a dialyzer device (8), in particular a high-flux dialyzer, with a semi-permeable membrane which separates the treatment unit into two chambers

Methodology Applied
Scientific EffectSemipermeable membrane separation: Semipermeable Membrane

Implementation Method 2

a dialysis fluid (treatment fluid) flows in the opposite direction through a suitably designed circuit via the second chamber

Methodology Applied
Scientific EffectCountercurrent flow:

Implementation Method 3

an adjustment sequence to apply a transmembrane pressure to values to maximize the convective exchange processes

Methodology Applied
Scientific EffectConvective exchange: Convection

Implementation Method 4

a delayed start of hemodiafiltration treatment... to reduce stress and to make a therapy goal more achievable... assuming that a secondary membrane has sufficiently formed

Methodology Applied
Scientific EffectSecondary membrane formation: Deposition (physical)

Data Source

PatentEP3231464B1Extracorporeal blood processing device
Publication Date: 2020.07.15 B BRAUN AVITUM
  • EP3231464B1 patent drawingFigure 1~2
  • EP3231464B1 patent drawingFigure 3
  • EP3231464B1 patent drawingFigure 4

AI summary

An apparatus and a method for extracorporeal blood treatment using a medical device for extracorporeal blood treatment, comprising at least one dialyzer device (8), wherein the apparatus has the following features: a user-operated and/or readable user interface for initiating blood treatment by hemodialysis based on preset values ​​for hemodialysis; at least one acquisition and/or computing unit for determining current values ​​and/or ratios of at least one blood flow, one ultrafiltration volume, one substitution volume and/or one substitution type; a sensor device for detecting therapy progress based on an output signal from a sensor device; a determination device for determining an ultrafiltration rate in the dialyzer device;a detection device for determining the formation time of a secondary membrane in the dialyzer device based on the determined ultrafiltration rate; a switching device for changing from hemodialysis to hemodiafiltration with postdilution after a predetermined time interval; and a control device for controlling the substitution quantity during hemodiafiltration with postdilution; and the method performs the following steps: initiating blood treatment by hemodialysis based on predefined values ​​for hemodialysis; determining current values ​​and/or ratios of at least one blood flow, one ultrafiltration quantity, one substitution quantity and/or one substitution type; detecting treatment progress based on an output signal from a sensor device (6);Determining the formation time of a secondary membrane on the dialyzer by determining a cross rate in the dialyzer device; switching from hemodialysis to hemodiafiltration with postdilution after a predetermined time interval; and controlling the substitution amount during hemodiafiltration with postdilution.