Pulsed Electric Field Sterilization for Dialyzers
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current sterilization methods for dialyzers, such as gamma radiation, electron beams, and ethylene oxide, face challenges including complex setup, high energy requirements, toxicity, and environmental hazards, making them unsuitable for safe and efficient sterilization of dialyzers for extracorporeal blood treatment.
Innovation Solution
A method and device utilizing pulsed electric fields (PEF) to sterilize dialyzers by generating a penetrating electric field between electrodes, which permeabilizes cell membranes and kills microorganisms, eliminating the need for radioactive isotopes or toxic substances, and allowing for a low-energy, efficient, and inline sterilization process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gamma radiation sterilization is used, then sterilization effectiveness is achieved, but the process requires complex shielding measures and takes several hours due to low dose rate
Solution Approach 1:
The patent replaces the mechanical/physical shielding system required for gamma radiation with an electrical field-based sterilization system. The pulsed electric field method uses capacitive discharge between electrodes to generate sterilizing electric fields without requiring radioactive isotopes or complex radiation shielding infrastructure, thus resolving the contradiction between sterilization effectiveness and device complexity.
2Reliability
If electron beam sterilization is used, then sterilization effectiveness is achieved, but complex and expensive accelerators are required and penetration depth is significantly lower than gamma rays
Solution Approach 1:
The patent substitutes the complex electron beam accelerator system with a simpler pulsed electric field generation system using capacitors and electrodes. This electrical field approach achieves sterilization without requiring high-energy particle accelerators, resolving the contradiction between sterilization effectiveness and device complexity while providing sufficient penetration through the dialyzer structure.
3Reliability
If ethylene oxide sterilization is used, then sterilization effectiveness is achieved, but the process is highly toxic, carcinogenic, and requires time-consuming removal of residual ethylene oxide
Solution Approach 1:
The patent replaces the chemical ethylene oxide sterilization process with a physical pulsed electric field method. This substitution eliminates the use of toxic and carcinogenic chemicals entirely, achieving sterilization through electrical field-induced cell membrane permeabilization without leaving harmful residues, thus resolving the contradiction between sterilization effectiveness and harmful factors.
4Reliability
If hot steam sterilization is used, then sterilization effectiveness is achieved, but a lot of energy is required and high temperatures place significant strain on dialyzer components
Solution Approach 1:
The patent changes the sterilization parameter from thermal energy (high temperature steam) to electrical energy (pulsed electric fields). This parameter change allows sterilization to occur at ambient or lower temperatures, dramatically reducing energy consumption and avoiding thermal damage to heat-sensitive dialyzer components while maintaining sterilization effectiveness through electric field-induced microbial cell disruption.
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
The PEF method effectively reduces microbial contamination to the required SAL10-6 level, providing a safe, efficient, and environmentally friendly sterilization process that can be integrated into the dialyzer manufacturing process, reducing energy consumption and eliminating the use of hazardous materials.
Implementation Method 1
electroporation is performed using an electric field, which can be generated, for example, as a short pulse from the discharge current of a capacitor, to permeabilize the cell membrane through various effects
Data Source
Figure 1~2
Figure 3~4
Figure 5
AI summary
A device for sterilizing a dialyzer for extracorporeal blood treatment includes a device for generating a pulsed electric field (4) which is arranged to generate a pulsed electric field penetrating the dialyzer (1) held between the first electrode (2) and the second electrode (2) of the device when a pulsed electric voltage is applied between a first electrode (2) and a second electrode (2) of the device.A method for sterilizing a dialyzer for extracorporeal blood treatment that can be carried out using this device includes, in a process for preparing or manufacturing the dialyzer (1), at least the steps of generating a pulsed electric field by means of a predetermined number of electrical pulses of a defined electrical voltage, a defined pulse duration and a defined pause time between the pulses, and applying the pulsed electric field to the dialyzer (1).