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: 1.73). 09/2007; 6(4):313-20. DOI: 10.1177/153303460700600408
Source: PubMed


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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    • "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.
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    • "The new generation of the Cliniporator device (Cliniporator VITAE, Igea, Carpi, Italy) has been designed for treatment of large volumes of tissue. This machine uses up to six independent needle-shaped electrodes that can be positioned independently to treat the tumor regardless of its shape and size [5] but also electrodes with fixed geometry can be used [35]. This pulse generator delivers electric pulses with standard duration of 100 μs with voltage and current amplitudes of up to 3,000 V and 50 A, respectively. "
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    • "The applied pulse duration was selected to be 20 μs, which is at the lower end of the spectrum of pulse durations.35 This minimizes computational time and would also be useful for minimizing tissue resistive heating, which is directly related to pulse duration. "
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