Design of an Irreversible Electroporation System for Clinical Use

IGEA S.r.l., Via Parmenide, 10/A, I-41012 Carpi (MO) Italy.
Technology in cancer research & treatment (Impact Factor: 1.89). 09/2007; 6(4):313-20. DOI: 10.1177/153303460700600408
Source: PubMed

ABSTRACT Irreversible electroporation is an ablation modality in which microseconds, high-voltage electrical pulses are applied to induce cell necrosis in a target tissue. To perform irreversible electroporation it is necessary to use a medical device specifically designed for this use. The design of an irreversible electroporation system is a complex task in which the effective delivery of high energy pulses and the safety of the patient and operator are equally important. Pulses of up to 3000 V of amplitude and 50 A of current need to be generated to irreversibly electroporate a target volume of approximately 50 to 70 cm3 with as many as six separate electrodes; therefore, a traditional approach based on high voltage amplifiers becomes hard to implement. In this paper, we present the process that led to the first irreversible electroporator capable of such performances approved for clinical use. The main design choices and its architecture are outlined. Safety issues are also explained along with the solutions adopted.

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Available from: Claudio Bertacchini, Aug 27, 2015
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    • "Following the encouraging results in animal models, human studies have started. The principals for the design of clinical NTIRE device appeared in [79], and the first NTIRE application in humans was performed on the prostate cancer [80]. In this study, 16 patients with prostate cancer were treated by four round square array electrodes separated 1-1.5 cm, 90 pulses, 70–100 μs duration, with applied voltage 1500 V, delivered at 10 Hz. "
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    ABSTRACT: Tissue ablation is an essential procedure for the treatment of many diseases. In the last decade, a non-thermal tissue ablation using intensive pulsed electric fields, called non-thermal irreversible electroporation (NTIRE), has rapidly emerged. The exact mechanisms responsible for cell death by NTIRE, however, are currently unknown. Nevertheless, the techniques remarkable ability to ablate tissue in the proximity of larger blood vessels, to preserve tissue architecture, short procedure duration, and shortened post-operative recovery period rapidly moved NTIRE from bench to bed side. This article provides an overview on the development of NTIRE, its current state of the art, challenges and future needs.
    IEEE transactions on bio-medical engineering 01/2013; 60(3). DOI:10.1109/TBME.2013.2238672 · 2.23 Impact Factor
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    ABSTRACT: A therapeutical application of electrical current to cardiac tissue for reviving the normal function (defibrillation, pacing) or for ablating pathological conduction pathways inevitably has to take into account the phenomenon of electroporation, the electric field— induced rupture of sarcolemma that is usually evidenced by a drastic unselective increase in cell membrane permeability to small ions and large molecules. This chapter describes some aspects of this phenomenon in relation to cardiac therapy and research. Particularly, it provides evidences that (1) electroporation of the heart tissue can occur during clinically relevant intensities of the external electrical field and (2) electroporation can affect the outcome of defibrillation therapy, being both pro- and antiarrhythmic.
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    ABSTRACT: The objective of this chapter is to present a historical review of the field of irreversible electroporation (IRE) in the context of its medical applications. Although relevant scientific observations were made since the 18th century, the electroporation phenomenon was not identified as an increase of membrane permeability until mid 20th century. After that, multiple applications of reversible electroporation emerged in vitro (DNA electrotransfer) and in vivo (electrogenetherapy and electrochemotherapy). Irreversible electroporation was tested commercially in the 60s as a bactericidal method for liquids and foods but its use in the context of medical applications was not studied until the early 2000s as an ablative method. The cell destruction mechanism of IRE is not based on thermal damage and this fact provides to IRE an important advantage over other physical ablation methods: the extracellular scaffolding, including the vessels, is preserved. Several surgical applications are now under study or even under clinical trial: ablation of hepatocarcinomas, ablation of prostate tumors, treatment of atrial fibrillation and treatment of vascular occurrences such as restenosis and atherosclerotic processes.
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