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Technical development of a new semispherical radiofrequency bipolar device (RONJA): ex vivo and in vivo studies

Abstract

The aim of this study is to inform about the development of a new semispherical surgical instrument for the bipolar multielectrode radiofrequency liver ablation. Present tools are universal; however they have several disadvantages such as ablation of healthy tissue, numerous needle punctures, and, therefore, longer operating procedure. Our newly designed and tested semispherical surgical tool can solve some of these disadvantages. By conducting an in vivo study on a set of 12 pigs, randomly divided into two groups, we have compared efficiency of the newly developed instrument with the commonly used device. Statistical analysis showed that there were no significant differences between the groups. On average, the tested instrument RONJA had shorter ablation time in both liver lobes and reduced the total operating time. The depth of the thermal alteration was on average 4 mm larger using the newly tested instrument. The new radiofrequency method described in this study could be used in open liver surgery for the treatment of small liver malignancies (up to 2 cm) in a single application with the aim of saving healthy liver parenchyma. Further experimental studies are needed to confirm these results before clinical application of the method in the treatment of human liver malignancies.

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Technical development of a new semispherical radiofrequency bipolar device (RONJA): ex vivo and in vivo studies

Author: Vávra, Petr
Publisher: Hindawi
Year: 2014
DOI: 10.1155/2014/532792
Source: https://dspace.vsb.cz/bitstreams/c3590cfc-9c96-4a7e-b4e8-558659e12c3e/download
Resea ch A icle
Technical De elopmen o a New Semisphe ical Radio equency
Bipola De ice (RONJA): Ex Vi o and In Vi o S udies
Pe Va a,1,2,3,4 Ma ek Penhake ,2Jan G epl,5Jana Ju ciko a,6Ji i Palecek,3
Michal C ha,7Jana Nowako a,2Ma in Hasal,2Ma ina Sk obanko a,3
Pe Os uszka,1Pe e Ihna ,1,3 Pa icie Delongo a,8,9 Dana Salouno a,10
Nagy A. Habib,4and Pa el Zonca1,3
1Depa men o Su ge y, Uni e si y Hospi al Os a a, 17. lis opadu 1790, 708 52 Os a a-Po uba, Czech Republic
2Depa men o Cybe ne ics and Biomedical Enginee ing, Facul y o Elec ical Enginee ing and Compu e Science,
VSB-Technical Uni e si y o Os a a, 17. lis opadu 15, 708 00 Os a a-Po uba, Czech Republic
3Depa men o Su ge y, Facul y o Medicine, Uni e si y o Os a a, Syllabo a 19, 703 00 Os a a 3, Czech Republic
4Li e and Panc eas Su ge y, Hamme smi h Hospi al, Impe ial College London, Du Cane Road, London W12 0HS, UK
5Facul y o Mechanical Enginee ing, VSB-Technical Uni e si y o Os a a, 17. lis opadu 15, 708 00 Os a a-Po uba, Czech Republic
6Depa men o Vice-P esiden o Science and Resea ch, Uni e si y Hospi al Os a a, 17. lis opadu 1790,
70852Os a a-Po uba,CzechRepublic
7CEITEC VFU, Uni e si y o Ve e ina y and Pha maceu ical Sciences B no, Palack´
eho 1/3, 612 42 B no-K ´
alo o Pole, Czech Republic
8Ins i u e o Pa hology, Uni e si y Hospi al Os a a, 17. lis opadu 1790, 708 52 Os a a-Po uba, Czech Republic
9Facul y o Medicine, Uni e si y o Os a a, Syllabo a 19, 703 00 Os a a 3, Czech Republic
10Depa men o Ma hema ical Me hods in Economy, Facul y o Economics, VSB-Technical Uni e si y o Os a a, 17. lis opadu 15,
708 00 Os a a-Po uba, Czech Republic
Co espondence should be add essed o Pe Va a; pe [email p o ec ed].uk
Recei ed 29 Janua y 2014; Accep ed 4 Ma ch 2014; Published 9 Ap il 2014
Academic Edi o : Tsoul as Geo gios
Copy igh © 2014 Pe Va a e al. This is an open access a icle dis ibu ed unde he C ea i e Commons A ibu ion License,
which pe mi s un es ic ed use, dis ibu ion, and ep oduc ion in any medium, p o ided he o iginal wo k is p ope ly ci ed.
The aim o his s udy is o in o m abou he de elopmen o a new semisphe ical su gical ins umen o he bipola mul ielec ode
adio equency li e abla ion. P esen ools a e uni e sal; howe e hey ha e se e al disad an ages such as abla ion o heal hy issue,
nume ous needle punc u es, and, he e o e, longe ope a ing p ocedu e. Ou newly designed and es ed semisphe ical su gical ool
can sol e some o hese disad an ages. By conduc ing an in i o s udy on a se o 12 pigs, andomly di ided in o wo g oups, we
ha e compa ed e iciency o he newly de eloped ins umen wi h he commonly used de ice. S a is ical analysis showed ha he e
we e no signi ican di e ences be ween he g oups. On a e age, he es ed ins umen RONJA had sho e abla ion ime in bo h
li e lobes and educed he o al ope a ing ime. The dep h o he he mal al e a ion was on a e age 4 mm la ge using he newly
es ed ins umen . The new adio equency me hod desc ibed in his s udy could be used in open li e su ge y o he ea men o
small li e malignancies (up o 2 cm) in a single applica ion wi h he aim o sa ing heal hy li e pa enchyma. Fu he expe imen al
s udies a e needed o con i m hese esul s be o e clinical applica ion o he me hod in he ea men o human li e malignancies.
1. In oduc ion
Hepa ocellula ca cinoma (HCC) is he six h mos common
cance , ep esen ing 6% o all cance s, he hi d mos com-
mon cause o cance dea h, and he mos common p ima y
malignancy o he li e [1]. Mos HCCs a e de eloped in
pa ien s wi h isk ac o s such as ch onic hepa i is B o C
and non i al li e ci hosis, which may be associa ed wi h
alcoholic li e disease o nonalcoholic a y li e disease [2]. I
is es ima ed ha 15–20% o colo ec al cance pa ien s p esen
Hindawi Publishing Co po a ion
BioMed Resea ch In e na ional
Volume 2014, A icle ID 532792, 7 pages
h p://dx.doi.o g/10.1155/2014/532792
2BioMed Resea ch In e na ional
Elec ode needle
Base hole
Base
Wings
Pin
Figu e 1: RONJA—new adio equency su gical ool.
synch onous li e me as ases. Mo eo e , li e me as ases will
de elopinhal o pa ien swi hcolo ec alcance in hecou se
o hei disease [3].
Me as ases o colo ec al ca cinoma (CLM) and hepa ocel-
lula ca cinoma (HCC) a e he mos equen indica ions o
li e su ge y.
Li e esec ion is he i s -line ea men op ion o
pa ien s wi h p ima y and seconda y li e umo s and well-
p ese ed li e unc ion. A be e li e unc ion assessmen ,
inc eased unde s anding o segmen al li e ana omy, using
mo e accu a e imaging s udies and he echnical p og ess
in su ge y a e he mos impo an ac o s ha ha e led o
educed mo ali y and mo bidi y o li e umo s [4].
Radio equency ene gy has been used in medicine o
mo e han one hund ed yea s and was g adually inco po a ed
in o li e su ge y. Radio equency abla ion was a p omising
me hod ha g adually de eloped, becoming one o he
s anda d me hods o he ea men o p ima y and seconda y
li e malignancies [5–8].
2. Ma e ials and Me hods
Fo c ea ing he p o o ype, a 3D model o he ins umen
had o be p epa ed. The p o o ype was p oduced by 3D
p in ing, which is mo e accu a e. The equipmen needed o
i s p oduc ion was p o ided by he Facul y o Me allu gy and
Ma e ials Enginee ing o he Technical Uni e si y Os a a.
The p ac ical es was hen pe o med a he Uni e si y
Hospi al Os a a using a s anda d adio equency gene a o .
2.1. RONJA De ice Desc ip ion. A new layou o elec odes
con ains h ee and wo g oups o elec odes in a squa e shape
posi ioned on he edges o a egula polygon. Th ee g oups o
elec odes a e posi ioned on one elec ode wing and he o he
wo g oups a e posi ioned on he second wing (Figu e 1).
Elec ode needles on each wing bu n a semisphe ical a ea
in he li e issue. The second wing bu ns an a ea be ween
he bu ned a eas by he i s wing. I is necessa y o u n he
ins umen by 90∘be ween each s ep and o bu n he issue
in ou s eps.
2.2. RONJA De ice Design and Cons uc ion. Bo h wings
and ing base o his new su gical ins umen we e c ea ed
wi h he apid p o o yping echnology on dimension SST 768
di ec ly om he 3D CAD model. This machine uses FDM
( used deposi ion modeling) echnology o c ea e compo-
nen sina e ysho ime omABSplas icma e ial.S ainless
s eel was used o p oduce he elec ode needles (Figu e 3).
The new ins umen RONJA, which has an asymme ical
elec ode layou , consis s o a ing-shaped base, wo wings
wi h ixed elec ode needles, and wo connec ing powe
wi es. In he base ing, he e a e a numbe o holes o guide
he elec ode needles in o he issue (Figu e 2). The elec ode
needles wi h a qua e -ci cle shape a e bipola . The needles
a e powe ed in each wing sepa a ely, be ween he inne and
ou e semici cles. One pole o he RONJA ins umen is made
by one semici cle o needles. Bo h wings a e connec ed o
he base h ough pins in such a way ha , a e inse ion o
bo h wings wi h needles in o he base, a hal -hemisphe e
shape o nec o ic issue will be c ea ed a ound he umo
(Figu e 4).
The idea o cons uc ing his ool wi h an asymme ical
layou o elec odes is comple ely new and i has no been
used o hese ypes o ins umen s so a .
2.3. Ex Vi o Tes ing. Ex i o es ing ook place a he
Uni e si y Hospi al Os a a on po cine li e issue because
o i s simila i y o human li e .
The main goal o he es ing was o unde s and whe he
he new p oposed elec ode layou is sui able o su icien
issuebu ningand o c ea ingasa e yzonea ound he
umo (Figu e 5). Ano he goal o he s udy was o disco e
any po en ial aul s and o de e mine powe le el o in i o
es ing. The ins umen was connec ed o a commonly used
adio equency gene a o . This gene a o is used in human
medicine o su ge y wi h cu en ly a ailable ins umen s.
2.4. In Vi o Tes ing. In i o es ing was conduc ed in 2012 on
a se o 12 pigs (Sus sc o a domes ica) andomly di ided in o
wo g oups. The expe imen was di ided in o h ee phases.
In he i s phase, heanimalsinbo hg oupsunde wen
BioMed Resea ch In e na ional 3
R35,00
11,24
11,24
16,90
16,90
16,90
22,56
22,56
4,00
R17,95
14,37
11,24
6,98
4,00
4,00
4,00
27,90
31,00
31,00
27,31
24,25 19,90
19,90
D awn by
G epl Jan Checked by App o ed by Da e Da e
(7 h No embe 2009)
Scale
Radius o he needles Edi ion Page
1/1
2:1
Figu e 2: Scheme o a new elec odes layou o ou adio equency ool RONJA.
Figu e 3: P o o ype o he semisphe ical ool o ex i o s udy.
Figu e 4: Applica ion o RONJA de ice—ex i o expe imen .
middle lapa o omy and adio equency-assis ed li e esec-
ion unde gene al anes hesia. Pigs in g oup A unde wen
li e esec ion using he new es ed ool RONJA and pigs
Figu e 5: Resul o adio equency abla ion—semisphe ical nec o-
sis o li e issue.
incon olBg oupwe eope a edwi hacommonlyused
ou -elec ode bipola esec ion de ice. The nex phase o he
s udy ollowed 14 days a e he p ima y ope a ion and was
ocused on inspec ional lapa oscopy. In he las phase, 30 days
a e he i s in e en ion, all he pigs we e eu hanized and
samples we e pa hologically e alua ed.
The expe imen al p ojec (no. 65/2012) was app o ed by
he expe commi ee on animal wel a e o he Ve e ina y
and Pha maceu ical Uni e si y B no acco ding o he law
on he p o ec ion o animals agains c uel y, as amended by
pa ag aph 18, Ac no. 246/1992 Coll. The expe imen was
app o ed by he Minis y o Educa ion, You h and Spo
o he Czech Republic and was g an ed pe mission o be
ca ied ou on he 7 h o Sep embe 2012. Pigs, aged one
yea ,we ep o idedby heResea chIns i u eo Animal
P oduc ion in Uh ine es, Depa men o Pig B eeding in
4BioMed Resea ch In e na ional
Kos elec. Add ess: Komenskeho 1240, 51741, Kos elec, Czech
Republic, acc edi a ion numbe 444/2011-MZE-17214, alid
un il Ap il 6, 2016).
All h ee phases o he in i o expe imen ook place in
he esea ch ope a ing hea e o he Facul y o Ve e ina y
Medicine o he Ve e ina y and Pha maceu ical Uni e si y
B no. The su gical eam consis ed o wo su geons om he
su gical depa men o he Uni e si y Hospi al Os a a as
well as wo e e ina y su geons om he Ve e ina y and
Pha maceu ical Uni e si y B no. P io o he i s su ge y,
e e y pig unde wen an examina ion o i s blood coun , bio-
chemis y, and hemocoagula ion. All pigs we e in amuscu-
la ly p emedica ed. Anes hesia was induced by in a enously
adminis e ed P opo ol (No o ol, No b ook Lab. L d., No h
I eland) (0.5–1 mg/kg) and hen main ained by cons an a e
in usion o P opo ol (0.1 mg/kg/min). All he ins umen s
used o he middle lapa o omy we e supplied by B. B aun
Medical, AESCULAP di ision. Monopola elec ocoagula-
ion EMED ES 350 wi h he ou pu o 255 W was used o his
pe o mance and a lapa o omy e ac o was applied. Two
li e esec ions we e pe o med on each pig: one om he
igh la e al lobe and one om he le la e al lobe o he li e .
The li e esec ion was ca ied ou using adio equency-
assis ed esec ion echnique. The subsequen li e ansec ion
was pe o med using a scalpel o su gical scisso s. Minimal
bleeding (no mo e han 20 mL) om he esec ion line was
ea ed wi h he adio equency ins umen as well. Resec ed
sampleswe e ixedin10% o malinsolu ion o subsequen
his opa hological examina ion. A e inspec ion o he su -
gical ield, he abdominal lapa o omy was closed in laye s.
Special an isep ic sp ay, sil e aluminum ae osol and bandage
p o ec ion agains con amina ion (Hen y Schein, Inc., Ge -
many),wasappliedon hesu gicalwound.Thepigs,unde
he con ol o a e e ina y anes hesiologis , we e eco e ed
om gene al anes hesia and housed in s anda d b eeding
boxes.Pos ope a i ely, heanimalswe egi enamoxicillin
(15 mg/kg) and meloxicam (0.4 mg/kg) in amuscula ly.
14 days a e he li e esec ion, he second phase was
execu ed o de e mine he s a us o healing o pos ope a i e
complica ions in he abdominal ca i y o each animal. Fo
his pu pose, a diagnos ic lapa oscopy o each pig was
pe o med o assess he pos ope a i e indings. AESCULAP
(B. B aun Medical., s. .o., he Czech Republic) lapa oscopy
ins umen a ion was used o su ge y: a human e sion o he
endoscopic ideo uni TELE PACK X and lapa oscopic op ics
HOPKINS wi h he ou e diame e o 5 mm and he leng h o
290 mm (KARL STORZ Endoscopy, Ge many).
The las phase o he es ing was pe o med 30 days a e
he i s su ge yandau opsieso he12pigswe epe o med
by a e e ina y pa hologis om he Ins i u e o Pa hological
Mo phology and Pa asi ology o he Ve e ina y and Pha ma-
ceu ical Uni e si y B no in he p esence o a pa hologis om
heUni e si yHospi alOs a a.Slaugh e ingwasdoneby he
p o ocol, lege a is. The animal ca casses we e disposed by
a ende ing se ice. All animals we e opened in abdominal
ca i y, hen in ho acic ca i y, ollowed by emo al o he
o gans.
Figu e 6: The mal came a image o he esec ion o li e
pa enchyma.
2.5. S a is ical Analysis. Da a be ween he s anda d de ice
g oup and RONJA g oup we e compa ed using he median
es o con inuous a iables and Fishe ’s exac es o
ca ego ical a iables. Da a a e p esen ed as mean ±s anda d
e o o mean (S.E.M.) and median o con inuous a iables
andascoun sandpe cen ages o ca ego ical a iables
(complica ions). S a is ical analysis was pe o med wi h IBM
SPSS so wa e e sion 18.0. A wo-sided alue o 𝑃 < 0.05was
conside ed s a is ically signi ican o all analyses.
3. Resul s and Discussion
3.1. Ex Vi o Tes o he New Layou . The adio equency
gene a o was se o 125 W ou pu o he i s es . Figu e 5
showsbu ned issuea e inse ionandabla ionbybo h
elec ode wings. A eas we e bu ned pe ec ly e en be ween
he squa e needle g oups. Wi h his con igu a ion, only wo
s eps would be po en ially equi ed. Time equi ed o bu n
he issuein i s es was43sec.
In he second es , he adio equency gene a o was se
o lowe powe ou pu , de aul 90 W. The issue was bu ned
only in squa e g oups o elec odes. Fou s eps we e necessa y
o c ea e a closed sa e y zone. The i s and second s eps
ook 37 sec and he hi d and ou h ones 9 sec. The he mal
imaging om in a ed came a showed ha he maximum
empe a u e a ound 64∘C was eached in he li e issue
and on needles du ing he p ocedu e (Figu e 6). Maximum
empe a u e on he ins umen su ace was 33∘C, meaning
ha useo hisins umen isabsolu elysa e o hesu geon.
Ex i o ial helped us es ablish he powe le el o in i o
es ing.
3.2. In Vi o Tes o RONJA Tool. Fo compa ison and s a is-
ical e alua ion, in i o es ing da a was collec ed including
esul s o blood samples, he alues eco ded du ing su ge y,
and also he his opa hological e alua ion. The o e all blood
analysis showed no ma ked di e ences in he obse ed alues
be o e esec ion, on he 14 h day a e su ge y, o on he 30 h
pos ope a i e day.
Du ing li e su ge y, he o al ope a ing ime and abla ion
imeo lobeswe emeasu edandcompa edinbo hg oups
(Table 1).
BioMed Resea ch In e na ional 5
Table 1: Ope a ing da a: he e was a signi ican di e ence (𝑃 = 0.005) in supplied powe be ween he g oups.
S anda d de ice; RONJA; 𝑃 alue
mean ±S.E.M. (median) mean ±S.E.M. (median)
Weigh 1 (kg) 50.83 ±3.55 (47.50) 53.00 ±4.69 (55.50) 0.567
To al ope a ing ime (min) 69.00 ±6.76 (77.00) 57.50 ±3.99 (53.50) 0.567
Abla ion ime o le lobe (min) 11.67 ±2.11 (11.50) 8.83 ±1.25 (7.50) 0.567
Abla ion ime o igh lobe (min) 8.50 ±0.89 (8.00) 7.33 ±0.84 (7.00) 1
Supplied powe (W) 90.00 (unchanging) 81.67 ±1.67 (80.00) 0.005
Weigh 2 (kg) 52.92 ±3.85 (49.50) 55.17 ±4.11 (57.50) 0.567
Lapa oscopic o al ime (min) 25.33 ±5.08 (23.50) 27.17 ±4.66 (23.00) 1
Ac ual ime o lapa oscopy (min) 13.83 ±3.89 (14.00) 6.00 ±1.16 (5.00) 0.567
Weigh 3 (kg) 58.82 ±4.35 (61.00) 58.83 ±4.89 (59.90) 1
To al weigh inc emen (kg) 6.62 ±1.46 (7.00) 5.83 ±0.88 (6.65) 0.567
Li e weigh (kg) 1.54 ±0.13 (1.50) 1.48 ±0.11 (1.48) 1
Table 2: Da a conce ning complica ions: he e we e no signi ican di e ences be ween he g oups.
S anda d de ice;
𝑛(%)
RONJA;
𝑛(%) 𝑃 alue
Complica ions du ing su ge y 0 (0) 1 (16.7) 1
Pos ope a i e complica ions 1 (16.7) 0 (0) 1
Complica ions du ing lapa oscopy 0 (0) 4 (66.7) 0.061
Pos ope a i e adhesions (li e ) 6 (100) 6 (100) —
Pos ope a i e adhesions (spleen) 2 (33.3) 2 (33.3) 1
Pa hological indings—asci es 1 (16.7) 2 (33.3) 1
Pa hological indings—abscess 0 (0) 1 (16.7) 1
Pa hological indings in lungs 4 (66.7) 2 (33.3) 0.567
The es ed ins umen RONJA had sho e abla ion ime
in le lobe by 2.84 minu es and 1.17 minu es in igh lobe han
he commonly used de ice. The newly designed ins umen
also sho ened ope a ing ime by 11.5 minu es compa ed o
he s anda d de ice (Table 1). S a is ical analysis using he
median es (𝑃 alue was compu ed by Fishe ’s exac es )
ailed o demons a e any signi ican di e ences be ween he
wo g oups. The powe deli e y o he adio equency ene gy
gene a o was op imized du ing he su gical p ocedu e.
The powe supply was educed o 80 W a e obse ing i
had he same e ec as he supply o 90 W. The commonly
used de ice had a powe supply o 90 W. Abla ion imes
we e de e mined au oma ically by he adio equency ene gy
gene a o (Table 1).
Only one complica ion occu ed du ing he li e su ge y
(Table 2). A spleen was dese osa ed in a pig in es ed g oup
A. In his animal, a se ous e usion o 250 mL was obse ed
du ing pa homo phological e alua ion.
The con ol lapa oscopy showed pos ope a i e adhesions
in all 12 animals. No se ious pos ope a i e complica ions
occu ed. Only one ad e se e en appea ed du ing an
inspec ion lapa oscopy. The ans e se colon o one pig
in expe imen al g oup A was inju ed when es ablishing
capnope i oneum. The e we e no li e abscesses, bilia y leaks,
subhepa ic abscesses, hema omas, o signs o pe i oni is in
any animal o bo h g oups.
Dea h o one pig in con ol g oup B occu ed in he
pos ope a i e pe iod a e lapa oscopy pe o mance. An
au opsy was execu ed and an acu e ca a hal-pu ulen b on-
chopneumonia, onsilli is, and hini is we e de ec ed. The
cause o dea h was de e mined as animal ci cula o y ailu e
due o espi a o y insu iciency in he pos ope a i e pe iod
in connec ion o mycoplasmal in ec ion. The abdominal
ca i y a e su ge y was examined wi hou any pa hological
indings.
Allpigshadawellhealedsu u ewi hou anysec e-
ion in he linea alba.In heabdominalca i y,a ib ous
synechia was de ec ed in pa s o he esec ed li e lobes
wi h pe i oneum and some adhesions we e ound be ween
he li e lobes and s omach, omen um, o loops o jejunum.
Resec ion ma gins in he li e lobes we e mos ly co e ed
wi h ib ous issue a he adhesions. Fou emale pigs had a
less se ous e usion in hei abdominal ca i ies. The ho acic
ca i y in ou pigs was wi hou adhesions and e usions. The
lungs o i e pigs had pa hological indings consis ing o

6BioMed Resea ch In e na ional
Table 3: Da a conce ning he mal al e a ion: he e we e no signi ican di e ences be ween he g oups.
S anda d de ice; RONJA; 𝑃 alue
mean ±S.E.M. (median) mean ±S.E.M. (median)
The mal al e a ion a he esec ion ma gin (%)— igh lobe 98.33 ±1.67 (100.00) 98.33 ±1.67 (100.00) —
The mal al e a ion a he esec ion ma gin (%)—le lobe 100.00 (unchanging) 95 ±3.42 (100.00) —
Maximum dep h o nec osis (mm)— igh lobe 13.00 ±1.61 (13.00) 14.83 ±2.20 (14.00) 1
Maximum dep h o nec osis (mm)—le lobe 13.67 ±1.94 (14.00) 14.00 ±0.97 (13.50) 1
Weigh o esec ed pa icle (g)— igh lobe 9.55 ±1.37 (10.20) 15.33 ±2.65 (14.40) 0.567
Weigh o esec ed pa icle (g)—le lobe 11.75 ±1.29 (11.30) 14.75 ±1.05 (14.25) 0.567
Maximum dep h o he mal al e a ion (cm)— igh lobe 1.08 ±0.08 (1.00) 1.42 ±0.07 (1.40) 0.08
Maximum dep h o he mal al e a ion (cm)—le lobe 1.08 ±0.05 (1.00) 1.45 ±0.07 (1.45) 0.08
Figu e 7: In i o s udy—ope a ing ield and condi ion o li e issue
a e semisphe ical excision.
a elec a ic bea ings—acu e in lamma o y o ch onic b on-
chopneumonia. A ib inoid, pu ulen pe ica dial e usion was
obse ed in one o hese pigs. Samples o he igh and le
hepa iclobewe ecollec ed omallpigs o ahis ological
examina ion.
The his opa hological e alua ion o he mal changes a
he esec ion ma gin showed a s ong he mal al e a ion
in bo h g oups. The dep h o he he mal al e a ion was
on a e age 4 mm la ge in g oup A using he newly es ed
ins umen ; dispe sion o alues was 12–17 mm. S a is ical
analysis using he median es (𝑃 alue was compu ed by
Fishe ’s exac es ) did no show any signi ican di e ences
be ween he g oups (Table 3).
The s a is ical analysis showed ha he e we e no any
di e ences be ween he es ed g oup A and he s anda d
g oup B.
4. Discussion
Ou ex i o and in i o expe imen al s udies demons a ed
he easibili y and sa e y o he newly de eloped semisphe ical
bipola de ice RONJA o he li e abla ion and esec ion.
The e we e no s a is ically signi ican di e ences be ween he
new es ed de ice and he gene ally used mul iple needle
de ice. A sphe ical a ea o coagula ed nec osis was achie ed
in all cases using he new semisphe ical adio equency
de ice RONJA (Figu e 7).
The main ad an ages o he RONJA de ice agains he
commonly used mul iple needle de ice include educ ion
Figu e 8: Mic oscopic sec ion o li e biopsy, he mal al e a ion o
hepa ic issue, pe i asal edema, and cen al eins dila a ion.
o needle punc u es in o li e issue, as e abla ion ime,
and, he e o e, educ ion o o al ope a ing ime and o
possibili y o epea ed esec ions in case o me as a ic elapse
o p og ession o he disease because o a be e p ese a ion
o he heal hy li e issue.
Manyau ho sha eusedapo cinemodelin easibili yand
sa e y s udies o de ices o adio equency abla ion. W igh
e al. compa ed adio equency and mic owa e abla ion
on he g oup o nine een pigs [9]. They concluded ha
mic owa e and adio equency abla ion zones a e simila in
pa hologic appea ance and imaging cha ac e is ics. Using ou
RONJA de ice, we also ha e no obse ed any di e ence in
he his opa hological e alua ion o he abla ion (Figu e 8).
Va ada ajulu e al. (2009) pe o med RFA o po cine li e
using he e ac able umb ella-shaped elec ode a ay wi h
e ec i e coagula ion nec osis o la ge a eas [10]. Lee e al.
(2013) con i med ha RFA p ocedu es using 15-G Oc opus
elec odes a e use ul and sa e o c ea ing a la ge abla ion
o po cine li e in a single elec ode model as well as in he
mul iple elec odes model [11].
Schu e al. used a po cine model wi h he aim o es ing
a new de ice consis ing o a linea a ay o blade-shaped
1 cm wide adio equency (RF) elec odes 1.5 cm apa . A
o al o 7 li e lobes we e esec ed om 2 domes ic swine
in his s udy. The au ho s de eloped a de ice ha apidly
coagula ed he hepa ic esec ion plane in an animal model.
In he au ho s’ opinion he new de ice shows p omise in he
e o o educe blood loss and ope a ing ime du ing li e
and kidney esec ions [12].
BioMed Resea ch In e na ional 7
5. Conclusion
We ha e designed and de eloped a new semisphe ical bipola
adio equency de ice ha apidly coagula es he hepa ic
esec ion plane in a po cine model. Ou p o o ype was able
o coagula e he semisphe ical con ou o li e pa enchyma
wi h success ul coagula ion o all blood essels. This de ice
shows p omise in e o s o educe heal hy li e pa enchyma
esec ion du ing li e su ge y in a po cine model. By pe -
o ming esec ion o pig li e pa enchyma using he new
semisphe ical de ice, we ha e con i med ha his new
me hodise ec i eandsa e.Thede icecouldbeusedin he
ea men o small malignancies (up o 2 cm in diame e ) in
pe iphe al pa s o li e lobes. Howe e , i is no sui able o
esec ions in he a ea o hepa ic hilus.
Fu u e animal and clinical s udies will need o e alua e
semisphe ical li e RF esec ion wi h espec o he local
ecu ence o hepa ic umo s.
Con lic o In e es s
The au ho s decla e ha he e is no con lic o in e es s
ega ding he publica ion o his pape .
Acknowledgmen s
This wo k was suppo ed by MH CZ-DRO-FNOs/2012,
MH CZ-DRO-FNOs/2013, and SGS VSB-TUO, G an no.
SP2013/116, and by he P ojec “CEITEC—Cen al Eu o-
pean Ins i u e o Technology” (CZ.1.05/1.1.00/02.0068) om
he Eu opean Regional De elopmen Fund. The wo k and
he con ibu ions we e suppo ed by he P ojec SP2013/35
“Biomedical enginee ing sys ems IX” and TACR TA01010632
“SCADA sys em o con ol and measu emen o p ocess in
eal ime.” The pape has been elabo a ed in he amewo k
o he IT4 Inno a ions Cen e o Excellence P ojec , Reg.
no. CZ.1.05/1.1.00/02.0070, suppo ed by he Ope a ional
P og amme “Resea ch and De elopmen o Inno a ions”
unded by S uc u al Funds o he Eu opean Union and s a e
budge o he Czech Republic.
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