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.
    IEEE transactions on bio-medical engineering 01/2013; 60(3). DOI:10.1109/TBME.2013.2238672 · 2.35 Impact Factor
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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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    ABSTRACT: Electrochemotherapy, a combination of high voltage electric pulses and of an anticancer drug, has been demonstrated to be highly effective in treatment of cutaneous and subcutaneous tumors. Unique properties of electrochemotherapy (e.g., high specificity for targeting cancer cells, high degree of localization of treatment effect, capacity for preserving the innate immune response and the structure of the extracellular matrix) are facilitating its wide spread in the clinics. Due to high effectiveness of electrochemotherapy in treatment of cutaneous and subcutaneous tumors regardless of histological origin, there are now attempts to extend its use to treatment of internal tumors. To advance the applicability of electrochemotherapy to treatment of internal solid tumors, new technological developments are needed that will enable treatment of these tumors in daily clinical practice. New electrodes through which electric pulses are delivered to target tissue need to be designed with the aim to access target tissue anywhere in the body. To increase the probability of complete tumor eradication, the electrodes have to be accurately positioned, first to provide an adequate extent of electroporation of all tumor cells and second not to damage critical healthy tissue or organs in its vicinity. This can be achieved by image guided insertion of electrodes that will enable accurate positioning of the electrodes in combination with patient-specific numerical treatment planning or using a predefined geometry of electrodes. In order to be able to use electrochemotherapy safely for treatment of internal tumors located in relative proximity of the heart (e.g., in case of liver metastases), the treatment must be performed without interfering with the heart's electrical activity. We describe recent technological advances, which allow treatment of liver and bone metastases, soft tissue sarcomas, brain tumors, and colorectal and esophageal tumors. The first clinical experiences in these novel application areas of electrochemotherapy are also described.
    Medical & Biological Engineering 11/2012; 50(12). DOI:10.1007/s11517-012-0991-8 · 1.73 Impact Factor
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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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    ABSTRACT: Irreversible electroporation (IRE) is a novel ablation tool that uses brief high-voltage pulses to treat cancer. The efficacy of the therapy depends upon the distribution of the electric field, which in turn depends upon the configuration of electrodes used. We sought to optimize the electrode configuration in terms of the distance between electrodes, the depth of electrode insertion, and the number of electrodes. We employed a 3D Finite Element Model and systematically varied the distance between the electrodes and the depth of electrode insertion, monitoring the lowest voltage sufficient to ablate the tumor, V(IRE). We also measured the amount of normal (non-cancerous) tissue ablated. Measurements were performed for two electrodes, three electrodes, and four electrodes. The optimal electrode configuration was determined to be the one with the lowest V(IRE), as that minimized damage to normal tissue. The optimal electrode configuration to ablate a 2.5 cm spheroidal tumor used two electrodes with a distance of 2 cm between the electrodes and a depth of insertion of 1 cm below the halfway point in the spherical tumor, as measured from the bottom of the electrode. This produced a V(IRE) of 3700 V. We found that it was generally best to have a small distance between the electrodes and for the center of the electrodes to be inserted at a depth equal to or deeper than the center of the tumor. We also found the distance between electrodes was far more important in influencing the outcome measures when compared with the depth of electrode insertion. Overall, the distribution of electric field is highly dependent upon the electrode configuration, but the optimal configuration can be determined using numerical modeling. Our findings can help guide the clinical application of IRE as well as the selection of the best optimization algorithm to use in finding the optimal electrode configuration.
    Radiology and Oncology 06/2012; 46(2):126-35. DOI:10.2478/v10019-012-0026-y · 1.91 Impact Factor
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