Abstract
Electroporation is an emerging technology, with great potential in many different medical and biotechnological applications, food engineering and biomass processing. Large variations of biological load characteristics, however, represent a great challenge in electroporator design, which results in different solutions. Because a clinical electroporator is a medical device, it must comply with medical device regulative and standards. However, none of the existing standards directly address the operation or electroporator’s performance requirements. In order to evaluate clinical, laboratory and prototype electroporation devices during the development process, or to evaluate their final performance considering at least from the perspective of output pulse parameters, we present a case study on the design of an electronic emulator of biological tissue as an electrical load during electroporation. The proposed electronic load emulator is a proof of concept, which enables constant and sustainable testing and unbiased comparison of different electroporators’ operations. We developed an analog electrical circuit that has equivalent impedance to the beef liver tissue in combination with needle electrodes, during high voltage pulse delivery and/or electroporation. Current and voltage measurements during electroporation of beef liver tissue ex vivo, were analyzed and parametrized to define the analog circuit equation. An equivalent circuit was simulated, built and validated. The proposed concept of an electronic load emulator can be used for “classical” electroporator (i.e., not nanosecond) performance evaluation and comparison of their operation. Additionally, it facilitates standard implementation regarding the testing protocol and enables quality assurance.
Highlights
Electroporation is an emerging platform technology, with great potential [1,2,3]
In the scope of this paper we present an idea of an analog electrical circuit that emulates biological tissue, beef liver tissue in combination with needle electrodes, undergoing high voltage pulse delivery and/or electroporation
The negative spike is present in the case of biological tissue, but we only modeled the dynamics of the pulse to facilitate calculations, we neglected the rise, fall time and post pulse dynamics
Summary
Electroporation is an emerging platform technology, with great potential [1,2,3]. One of the most successful electroporation-based applications in medicine is an anti-tumor therapy, called electrochemotherapy (ECT). Through the permeabilized cell membrane transport of chemotherapeutic drug, bleomycin or cisplatin is increased and considerably higher cytotoxicity is reached [4,5,6,7]. According to Standard Operating Procedure for ECT [8,9] in clinical practice, mainly eight square wave pulses often reported as amplitude to distance ratio in range from 1000 to 1500 V/cm, 100 μs pulse duration each and repetition frequency of 1 Hz or 5 kHz are applied to the tissue. A medical device that enables electroporation is called an electroporator; it is a high voltage pulse generator.
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