Instrumentation & Measurement Magazine 23-2 - 79

Fig. 3. Different types of electrodes (by IGEA S.p.A.). (a) Plate electrodes.
(b) Linear (parallel needle) array electrodes (first top image), adjustable linear
needle electrodes with needle-length adjustment with 5 mm increment (bottom
two images). (c) Finger electrodes with orthogonal linear needles (left) and
longitudinal linear needles (right). (d) Hexagonal needle electrodes (first top
image), adjustable hexagonal configuration needle electrodes with needlelength adjustment in 5 mm increments (bottom two images). (e) Endoscopic
electrode EndoVE (Endoscopic Vacuum Electrode) which is mounted at the head
of an endoscope and utilizes a vacuum source to drag the tissue alongside with
the electrode. (f) Individual (long) needle electrodes for variable electrodegeometry (from 2 to 6 electrodes with 16-30 cm long needle and active tip of
3 or 4 cm).

they are considered to be invasive and are used to treat deeper
tissues.
The updated SOP [18] defines five types of electrodes
(made of stainless-steel) that are commercially available (IGEA
S.p.A, Carpi MO, Italy) and can be used together with the
Cliniporator depending on the treated area:
Plate electrodes: with 8 mm gap in-between, used for superficial skin lesions (Fig. 3a).
Linear array electrodes: (parallel needle array) that have 2 arrays of 4 needles (with needle length of 10-, 20- or 30 mm),
separated by 4 mm distance, used for smaller tumors (recommended to be used for tumors in the facial region) with local
anesthesia (Fig. 3b).
Hexagonal needle electrodes: with needle length of 10-, 20- or
30 mm, used for treatment of larger areas, e.g., cutaneous metastases (Fig. 3d).
Finger electrodes: (longitudinal or orthogonal) with needle
length of 5- or 10 mm, used for treatment of mucosal tumors,
e.g., in the oral cavity (Fig. 3c).
April 2020	

Adjustable electrodes: (linear (Fig. 3b) or hexagonal (Fig. 3d))
allow adjustments in needle length (from 5 mm to 40 mm with
5 mm increments) for better support in treatments of tumors
with heterogeneous size.
In addition, the endoscopic electroporation system EndoVe (Mirai Medical, Galway, Ireland) was developed to be
used with the ePORE electroporation generator, which is
also suitable for the Cliniporator (Fig. 3e). Furthermore, long
freely-placeable needle electrodes (Fig. 3f) were introduced,
and new minimally invasive laparoscopic expandable needle
electrodes are being developed by IGEA S.p.A [3], [16].
Pulse parameters are defined in the SOP as a result of
numerous previously conducted studies. For each pulse delivering, 8 square-wave pulses of 100 μs with pulse amplitude of
about 1000 V (1000 V up to 1300 V) across an 8 mm distance between plate electrodes should be delivered at repetition rate of
either 1 Hz or 5 kHz. ECT with pulse repetition rate of 5 kHz
is mandatory for hexagonal needle electrodes because the
treatment (delivering 8x12 = 96 pulses) with 1 Hz repetition
rate would extend over a prohibitively long time and highfrequency (5 kHz) pulses reduce the number of contractions.
Nevertheless, several applications may be needed to cover the
whole tumor volume in a single session.
All electrodes which are commercially available and meant
to be used with the Cliniporator are for single use for a particular patient and only for a single session (for one nodule or
several similar nodules in the same patient). In a case of more
nodules of different sizes, more than one electrode type may be
needed for a particular patient in the same session.
The galvanic isolation of the output is preferably implemented in the power supply and not in the output module
to have accurate measurement of the output signal. Output
current and voltage are measured at the output of the pulse
generator to implement current, energy and voltage limitations. The SOP should define the maximum expected current
or minimal expected resistance of the load. The maximum
current of the device should be 10% or 20% higher than the
maximum expected current, which is 20 A for the Cliniporator
EPS02. SOP defines the maximum treatment voltage as 1300
V/cm voltage-to-distance ratio times 8 mm which is equal to
1040 V. The maximum voltage is defined by the SOP and tolerances and is 1000 V for the Cliniporator EPS02. The maximum
energy should be equal to the maximum treatment time, times
maximum current, times maximum voltage.
Considering the SOP, for square wave pulses (described
by the amplitude and the pulse duration tFWHM, where FWHM
is Full Width at Half Maximum, we propose the following
tolerances:
◗◗ the pulse amplitude between 15% and 85% of FWHM
should not rise over or fall below 110% or 90% of SOP
amplitude (Fig. 4a);
◗◗ the FWHM should not be longer or shorter than ±8% of
SOP FWHM;
◗◗ delivered number of pulses should be exactly the same
as in the SOP and variations of this parameter are not
allowed;

IEEE Instrumentation & Measurement Magazine	79



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