Alkali Hydroxide Regeneration for Apheresis Column Reusability

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Solution Overview

Problem

Current methods for regenerating apheresis columns used in CRP removal are inefficient, leading to increased treatment time, patient suffering, and high costs due to protein layer formation and clogging, which reduces the column's usability and requires multiple regeneration solutions, increasing overall regeneration time.

Innovation Solution

The use of an alkali hydroxide solution, preferably sodium hydroxide, for regeneration of apheresis columns, which effectively removes protein deposits and restores the column's functionality without acidic protein precipitation, allowing for single-step regeneration and preservation, thus reducing the number of rinsing steps and overall regeneration time.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional regeneration methods (acidic solutions like glycine/HCl) are used, then CRP can be removed from the column, but protein layers form and clog the column, reducing reusability and requiring multiple regeneration steps

Engineering Contradiction:
Improvecolumn reusabilityVSAvoidprotein layer formation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent changes the pH parameter from acidic (conventional glycine/HCl) to alkaline (NaOH solution pH 12-14). This parameter change fundamentally alters the regeneration mechanism: alkaline conditions prevent acidic protein precipitation that causes layer formation, while effectively removing bound CRP through different chemical mechanisms (saponification of ester bonds, disruption of hydrophobic interactions). This single parameter change resolves the contradiction by eliminating harmful protein deposition while maintaining effective CRP removal.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent inverts the conventional approach by using alkaline solutions instead of acidic solutions for regeneration. Conventional methods use acid to elute CRP, but this causes protein precipitation. The inverted approach uses base to achieve both CRP removal and prevention of protein layer formation, turning the harmful acidic environment into a beneficial alkaline one that solves both problems simultaneously.

Inventive Principle:
Principle #13The other way round (Inversion)

2Reliability

If multiple regeneration solutions are used to remove protein deposits, then column functionality is restored, but regeneration time increases and treatment efficiency decreases

Engineering Contradiction:
Improvecolumn functionalityVSAvoidregeneration time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent makes the alkaline regeneration solution universal by enabling it to perform multiple functions simultaneously: (1) remove bound CRP from the column, (2) prevent protein layer formation, and (3) clean the column for reuse. This single multi-functional solution replaces the conventional multi-step process requiring different solutions for each function, dramatically reducing regeneration time while maintaining column functionality.

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

Solution Approach 2:

The patent merges multiple regeneration functions into a single alkaline treatment step. Instead of sequentially applying different solutions for CRP removal, protein deposit removal, and column cleaning, the alkaline NaOH solution combines all these functions into one unified process, eliminating the need for multiple separate regeneration steps and reducing overall regeneration time.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If acidic regeneration solutions are used, then CRP binding capacity is restored, but acidic protein precipitation occurs, increasing device complexity and rinsing requirements

Engineering Contradiction:
ImproveCRP binding capacityVSAvoidrinsing steps
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent changes the pH parameter from acidic to alkaline, which fundamentally alters the chemical behavior during regeneration. Alkaline conditions prevent protein precipitation that occurs in acidic environments, eliminating the need for complex rinsing sequences designed to remove precipitated proteins. The single alkaline treatment step restores CRP binding capacity without generating the harmful precipitation that increases device complexity.

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

This approach significantly improves the reusability of apheresis columns, enabling 200 cycles or more without performance degradation, reduces treatment time, and minimizes patient suffering by simplifying the regeneration process and eliminating the need for multiple regeneration solutions.

Implementation Method 1

The use of an alkali hydroxide solution, preferably sodium hydroxide, for regeneration of apheresis columns, which effectively removes protein deposits and restores the column's functionality

Methodology Applied
Scientific EffectChemical dissolution:

Data Source

PatentUS20230090960A1Using an alkalihydroxide solution for the regeneration of an apheresis column
Publication Date: 2023.03.23 PENTRACOR GMBH
  • US20230090960A1 patent drawing
  • US20230090960A1 patent drawing
  • US20230090960A1 patent drawing

AI summary

The present invention relates to the use of alkali hydroxide for the regeneration of apheresis columns for the affinity chromatographic removal of CRP and a method for the simplified regeneration of apheresis columns for the affinity chromatographic removal of CRP with the use of an alkali hydroxide solution and apheresis devices which are designed in such a manner as to be resistant to alkali hydroxide solutions and to allow the regeneration of apheresis columns for the affinity chromatographic removal of CRP in continuous operation.