598 IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, VOL. 61, NO.
2, FEBRUARY 2014
Electromagnetic Thermotherapy System With Needle
Arrays: A Practical Tool for the Removal
of Cancerous Tumors
Sheng-Chieh Huang, Jui-Wen Kang, Hung-Wen Tsai, Yan-Shen Shan, Xi-Zhang Lin∗ , and Gwo-Bin Lee∗
Abstract—Thermotherapy has been a promising method to treat
tumor. In recent years, electromagnetic thermotherapy (EMT) has
been extensively investigated and holds the potential for a variety
of medical applications including for cancer treatment when com-
bined with minimally invasive surgery approach. In this study, an
alternating electromagnetic frequency was provided by an EMT
system to heat up stainless steel needle arrays which were inserted
into the target tumor to a high temperature, therefore leading to
local ablation of the tumor. A new two-section needle-array appara-
tus was further demonstrated to encompass the tumor to prevent
the tumor cells to spread after the treatment process. By using
the needle-array insertion apparatus, there is no limitation of the
treatment area; this method could, therefore, be applied for tumors
that are larger than 6 cm. It was first successfully demonstrated
in the in vitro experiments on porcine livers. Then an in vivo ex-
periment was directly conducted on pigs. The two-section needle
array incorporated with the needle-array apparatus and EMT was
demonstrated to be promising for no-touch isolation treatment of
cancerous tumors.
Index Terms—Ablation, electromagnetic thermotherapy (EMT)
system, encompassing treatment, minimally invasive surgery
(MIS), needle arrays.
I. INTRODUCTION
FFECTIVE treatments for cancer can significantly reduce
E the mortality of this deadly disease. Among the devel-
oped methods, no-touch isolation treatment [1]–[3] has been
broadly applied because it prevents tumor cells to spread from
the tumor after the treatment and therefore effectively prevents
Manuscript received June 29, 2013; revised August 18, 2013 and September
18, 2013; accepted October 4, 2013. Date of publication October 23, 2013; date
of current version January 16, 2014. This work was supported in part by the
National Science Council under Grant NSC 101–2325-B-006–014. Asterisks
indicate corresponding authors.
S.-C. Huang is with the Department of Power Mechanical Engineering,
National Tsing Hua University, Hsinchu 30013, Taiwan (e-mail: xaviersty@
hotmail.com).
J.-W. Kang is with the Department of Internal Medicine, National
Cheng Kung University, Tainan City 704, Taiwan (e-mail: pete1594@
yahoo.com.tw).
H.-W. Tsai is with the Department of Pathology, National Cheng Kung Uni-
versity, Tainan City 704, Taiwan (e-mail: hungwen@mail.ncku.edu.tw).
Y.-S. Shan is with the Department of Surgery, National Cheng Kung Univer-
sity, Tainan City 704, Taiwan (e-mail: ysshan@mail.ncku.edu.tw).
∗ X.-Z. Lin is with the Department of Internal Medicine, National Cheng Kung
University, Tainan City 704, Taiwan (e-mail: linxz@mail.ncku.edu.tw).
∗ G.-B. Lee is with the Department of Power Mechanical Engineering,
National Tsing Hua University, Hsinchu 30013, Taiwan (e-mail: gwobin@
pme.nthu.edu.tw).
Color versions of one or more of the figures in this paper are available online
at http://ieeexplore.ieee.org.
Digital Object Identifier 10.1109/TBME.2013.2285233
0018-9294 © 2013 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission.
See http://www.ieee.org/publications standards/publications/rights/index.html for more information.
post-treatment relapses. The similar techniques could be applied
for resection of other organs. However, the hollow organs, such
as gut, ureters, and bladders, are not the target applications for
this technology because the resected ends are usually resutured
together. If the resutured (anastomotic site) areas have necrotic
tissues remained, the suture usually cannot heal, and usually
results in the leakage of the gut. In this method, physicians first
either remove or induce necrosis in the normal tissue around
the tumor to isolate the tumor and then treat the target tumor
by chemotherapy or thermotherapy [4]–[6]. Thermal ablation
has also been a popular method for cancer treatment since its
advent. This method involves rapidly and locally heating the
tumor to above 60 ◦ C to cause necrosis of tumor cells. It is a
simple therapy with few side effects and complications. In re-
cent years, thermal ablation has been combined with minimally
invasive surgery (MIS) [7], [8] as a new approach for treating
cancer. For example, radio-frequency ablation (RFA) [9], [10],
microwave ablation [11], [12], and electromagnetic thermother-
apy (EMT) [13]–[16] have been applied in a variety of cancer
treatments such as organ resection surgery [17] and necrosis of
tumor cells in internal medicine [18]. RFA employs a probe that
passes an alternating electric current with a frequency ranging
from 460 to 500 kHz through the target region in the tissue and
rapidly and efficiently raises the local temperature to 90–110 ◦ C
to cause tissue ablation [19]. Alternatively, microwave ablation
is another treatment approach using thermal ablation in which a
probe delivers microwave energy to heat up water molecules in
the cells and therefore generate a high temperature to cause ab-
lation in the tissue. Applying RFA or microwave ablation in the
no-touch isolation treatment, however, is challenging because
RFA and microwave probes are expensive and the number of
probes that could be simultaneously applied during treatments
is, thus, limited to two to four probes [20], [21].
Alternatively, EMT has been extensively explored recently
and has been shown to be an effective tool for local thermal
ablation. The EMT system is usually equipped with induction
coils to generate a high-frequency electromagnetic field (EM
field). When a magnetic material (such as a needle or seeds) is
placed under the EM field, it generates significant heat due to
the eddy current and the hysteresis energy loss [22]. Note that
the eddy current only exists on the surface of the magnetic ma-
terials (needles) under the EMT. There is no eddy current in the
body. Therefore, the eddy current may not cause neuromuscular
stimulation. During the experiments, no neuromuscular stimu-
lation was observed. With this approach, the no-touch isolation
treatment could be effectively achieved since there is no limita-
tion in the number of needles placed under the induction coils of
HUANG et al.: ELECTROMAGNETIC THERMOTHERAPY SYSTEM WITH NEEDLE ARRAYS
the EM field. Compared with the probes for RFA or microwave
ablation, EMT needles have a simpler structure and can, there-
fore, be inexpensively manufactured. In particular, a two-section
needle composed of a magnetic section and a nonmagnetic sec-
tion was successfully applied in MIS under a high-frequency
EM field by our research group [17]. The two-section needle
could be used to avoid burning the normal tissue during MIS.
In order to apply EMT toward no-touch isolation treatments
for tumor removal, two additional requirements must be ad-
dressed. First, it is crucial to insert needles at accurate positions
or even at a desired depth to make sure the tumor could be
completely encompassed by the needles to achieve effective no-
touch isolation treatments. Therefore, a needle-array insertion
apparatus is of great need to control the distance between each
needle and the arrangement of the needle insertion. Second, the
number of needles used during treatments needs to be optimized
so that the pain induced by the needles during the treatment can
be minimized while still attaining sufficient tumor coverage.
A new treatment process was, thus, explored in this study. It
increased the ablation area of each needle such that the num-
ber of the two-section needles used during the treatment—and
hence the pain experienced by the patient—could be reduced.
As a demonstration, two-section needle arrays were inserted
into porcine livers to perform a no-touch isolation tissue abla-
tion without opening the abdomen. There are two major novel
aspects in this study. First, the needles were heated by the EM
field under the coils. Therefore, there is no limitation of the
numbers of the needles in the treatment and large-range tumors
(more than 3 cm in diameter) can be treated at the same time.
It is the main novelty of the study. Second, the structure of the
two-section needle is relatively simple such that it is relatively
cheap when compared with these existing probes.
The intensity of the EM field was found to decrease when
the needles were placed away from the induction coils [17]. The
distance away from the coils may affect the effective range of the
EM field to heat the needle arrays accordingly. The distribution
of the effective EM field was, therefore, explored in this work.
Moreover, two experiments were conducted to demonstrate its
capability, including in vitro and in vivo animal experiments.
The in vitro results showed that the developed apparatus and the
new therapy progress could successfully cause wider ablation of
the target tissue with fewer needles. The results from the animal
experiments showed that the livers of pigs were also successfully
ablated by using the needle arrays and the new therapy progress.
The developed EMT system and no-touch isolation treatment
process may provide a useful tool for removal of cancerous
tumors.
II. MATERIALS AND METHODS
A. Hardware
1) Electromagnetic Thermotherapy System: As depicted in
Fig. 1, the electromagnetic thermotherapy system (ETS) con-
sisted of a power supply (input: 380 V, 13 A, 60 Hz), a high-
frequency EM field generator equipped with induction coils with
a diameter of 30 cm (HP-Cube-35 kW, President Honor Indus-
tries, Taiwan), a cooling system (CW-36, Wexten Precise Indus-
tries, Taiwan) and a custom-made temperature control module,
599
Fig. 1. Schematic diagram of the developed ETS used for noncontract isolation
treatment.
which was used to prevent rapid rises of the needle temperature
under the EM field and maintain the treatment temperature at a
preset value with a variation of less than 1 ◦ C [17]. The temper-
ature control system, which controlled the heating rate at 1 ◦ C/s,
also helped prevent needles that were withdrawn from the target
tissue from sticking to the tissue and the laceration. Fig. 1 shows
a schematic diagram of the ETS. The total power consumption
of the system was about 35 kW, which was about 130% higher
than the model previously developed by Shan et al. [17]. Note
that the electric current was amplified to about 1400 A as the
input to the induction coils. The operating frequency was about
44 kHz when used 30-cm-diameter coils. To prevent electric
damage, the induction coils were coated with teflon for insula-
tion. The ETS is a noncontact treatment; that is, electric current
does not flow through the human or animal body during the
treatment, which is different from RFA. The hysteresis energy
loss and eddy currents were generated when the magnetic ma-
terial was placed under the high-frequency EM field. Since the
current flows through the coils and the magnetic field genera-
tor, significant EM field is generated accordingly to raise the
temperature of the needle over 100 ◦ C during the treatment. The
heat generated from the system could raise the temperature of
40 L of water from 26 to 50 ◦ C in 8 min. It is estimated that
about 120 kcal needs to be removed from the induction coils and
the generator per minute. Therefore, a cooling system is used
to keep the temperature of the coils and the generator at safe
temperature of 25–30 ◦ C.
B. Two-Section Needle for MIS
The two-section needle is a specifically designed apparatus
for the no-touch isolation treatment. The schematic diagram of
the two-section needle is shown in Fig. 2. It was composed
of a main needle and a secondary needle, both of which were
comprised of two sections. The upper 9-cm section of these two
needles was made of ceramic (a nonmagnetic material) for com-
ing into contact with the normal tissue such as skin or muscle
during MIS. The ceramic, nonmagnetic section of the needle
would not be heated under the EM field, which prevents the
normal tissues from being ablated and damaged by the inserted
needle. The lower 3-cm section of both needles was designed to
be inserted into the target tissue and was, therefore, made of a
magnetic material (304-stainless steel). When placed under the
EM field, the lower section of the needles would be heated to a
specifically set temperature to cause ablation of the target tissue.
600
Fig. 2. Schematic diagram of the two-section needle. It was composed of
a main needle and a secondary needle, which would be inserted into the main
needle. Teflon was coated on the surface of the main needle to prevent the needle
from sticking to the tissue. The temperature measurement point was situated
between the magnetic part and the nonmagnetic part in the secondary needle.
The length of the heating section could be custom-designed if a
larger ablation area is required.
The main needle was hollowed for encapsulating the sec-
ondary needle and if necessary, injecting drugs during treat-
ments. The surface of the main needle was coated with teflon
to prevent it from sticking to the tissue during the removal pro-
cess of the needle after the treatment. The outer diameter and
the inner diameter of the main needle were 1.8 and 1.2 mm,
respectively; the fine needle can, therefore, drastically reduce
the pain from inserting the needle. The secondary needle, which
was 1.0 mm in diameter, was designed for several purposes.
First, it provides structural support for the hollow main nee-
dle during the insertion process. Furthermore, the heating effect
during the treatment could be improved when compared to the
hollow needle since the lower section was made of magnetic
materials. The heating effect was based on the mass of the mag-
netic materials. When the mass of the needle was increased, the
heating effect was improved accordingly. During the heating
process, the secondary needle was inserted into the main nee-
dle. Both the first and the second needles were heated under the
electromotive force (EMF). More importantly, a thermocouple
(K-type, InterTech Technology, Inc., Taiwan) could be buried
inside the secondary needle for monitoring the temperature of
the needle during the treatment in real time. Note that the depth
of the inserted needles could be also adjusted because distance
marks have been made on the needles and the physician can
read the distance mark to know the depth of the magnetic part
of the needle in the tissue. Fig. 3(a) shows a photograph of the
main needle and the secondary needle while Fig. 3(b) shows a
photograph of an assembled needle.
C. Needle-Array Insertion Apparatus
The no-touch isolation treatment for MIS could be demon-
strated by using needle arrays under the EM field. A needle-array
insertion apparatus was designed to precisely control the ar-
rangement of the needles and the distance between each needle.
Fig. 4 shows the schematic diagram of the needle-array insertion
apparatus, which consists of five rotation shafts. Each rotation
shaft has five needle insertion holes. The distance between each
needle insertion hole was 1.5 cm. The selected distance was
based on the results acquired from the new treatment process
IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, VOL. 61, NO. 2, FEBRUARY 2014
Fig. 3. (a) (Top) Photograph of the main needle and (bottom) the secondary
needle. (b) Main needle was assembled with the secondary needle inside.
Fig. 4. Schematic diagram of the needle-array insertion apparatus. It was
composed of five rotation shafts with predesigned needle insertion holes.
and the needle arrays treatment; when the distance between
each needle was 1.5 cm, the tissue would be ablated completely.
During the needle insertion process, a needle that contains a
temperature sensor would be first inserted into the target tissue
under ultrasonic guidance [17]. The needle insertion apparatus
was then aligned with the temperature-monitoring needle by us-
ing an alignment mark located on the middle rotation shaft. The
insertion angle of the other needles on the same shaft could be,
therefore, adjusted to be aligned with the insertion angle of the
temperature-control needle. The angle of each rotation shaft can
be further adjusted such they could be aligned with the middle
rotation shaft. Finally, the needles can be inserted according to
the shape of the target tumor.
D. Animal Model
Lan-Yu pigs were maintained at the animal center of the
National Cheng Kung University (NCKU) under humane con-
ditions and in accordance with the animal-care guidelines set
forth by the Agriculture Council of Taiwan. Before the no-touch
isolation MIS, the pigs were anesthetized with intramuscular
injection of 0.02 mg/kg atropine (Sintong, Taoyuan, Taiwan),
2 mg/kg xylazine (Bayer, Leverkusen, Germany), and 10 mg/kg
Zoletil (Virbac, Carros, France). Following endotracheal intu-
bation, the animals received 1–3% isoflurane at 200 ml/kg/min
(Bexter, Guayama, USA) throughout the operation. The pigs
HUANG et al.: ELECTROMAGNETIC THERMOTHERAPY SYSTEM WITH NEEDLE ARRAYS
were observed for two weeks after the treatment. During the
observation period, the health of the pigs was monitored daily.
After the observation period, their livers were promptly removed
and processed for further histological examinations and the pigs
were sacrificed by an overdose of anesthesia.
E. Experimental Setup
1) Distribution of the EM Field: The intensity, and hence the
effective range, of the EM field is determined by the distance
from the coils. In the study, the no-touch isolation MIS would
be demonstrated when the lower section of the needle (heating
part) was placed 8–12 cm away from the coils, because of the
average distance between the skin and the target tissue in the
liver was 8–12 cm in the human. To make sure that all needles
could be heated up to the set temperature, the distribution of the
EM field was first explored. In this experiment, the intensity of
the EM field which was generated by the ETS was measured
by a tesla meter (model 7010, SYPRIS, USA). The sensor was
placed at different positions from −15 to 15 cm in the x-axis
(across the coils) on the x–y plane across the coils and every
3 cm away from the coils in z-axis (vertically) (x-, y-, and z-axis
were schematically shown in Fig. 1). Note that there is no any
EM field performance changes between the air and the tissue
because the intensity of the EM field would not change in the
nonmagnetic material. It only changed in the magnetic materials.
Since the tissue is the nonmagnetic materials, the results for EM
field measurement in the air may provide important information
for effective heating.
2) New EMT Process: In traditional EMT, the target tissue
is typically heated directly to a specified temperature and main-
tained the temperature of the needle to the end of the treatment.
A new treatment process for EMT was developed in this work
for increasing the ablation area of the needle under the EM
field since more efficient heat could be transferred to the sur-
rounding tissue from the heated needles. An internal shut-off
time was applied when the temperature of the needle reached
98 ◦ C. Totally, six different internal shut-off times (including 5,
10, 15, 20, 25, and 30 s) were tested while compared with a
base-line case, which no shut-off time treatment process was
referred. Note that during the internal shut-off time, the whole
system was turned OFF. The needle was first inserted into the
porcine liver and heated to 98 ◦ C under the EM field by using
the new treatment process with different internal shut-off time.
After the heating, the porcine liver was incised and the ablation
area was measured. Note that the key point to prevent excessive
dehydration and maintain good thermal conductivity was the
setting temperature of the temperature control module. From
our previous work [17], if the needle was heated under the EM
field without temperature control, the temperature of the needle
may be heated over 150 ◦ C and the tissue around the needle
would be carbonized. The burn black tissue would decrease the
thermal conductivity to reduce the ablation area of the needle.
On the other hand, if the temperature of the needle was too low
(less than the setting temperature), the ablation area would not
cover the tumor and therefore the treating effect was decreased
accordingly. Therefore, the temperature control was crucial in
this study.
601
3) In Vitro Test by Using the Needle Arrays: The distance be-
tween each needle plays an important role for the no-touch iso-
lation MIS thermal ablation surgery. In order to ensure that the
area encompassed by the needle array was completely ablated
under the EM field induction, the effective distance between
each needle has to be defined. In this experiment, a three-needle
array was inserted into a porcine liver in vitro with different dis-
tances between each needle. Because the effective ablation area
of a single needle under the EM field was about 1.0 cm [17], three
different distances, including 1.0, 1.5, and 2.0 cm were chosen
for testing. After needle insertion, the needle arrays were heated
up to 98 ◦ C under the EM field for 5 min, which was determined
to be an effective time period for EMS [17]. In order to observe
the ablation area, the porcine liver was incised right after the
heating and the ablation area was measured accordingly.
4) In Vivo Animal Testing: No-touch isolation MIS was per-
formed on three Lan-Yu pigs. As mentioned previously, the
temperature-control needle was first inserted into the pig liver
under ultrasonic guidance. The needle-array insertion apparatus
was then aligned with the temperature-monitoring needle. Fi-
nally, the other four needles were inserted into the liver around
the temperature-monitoring needle through the needle-array in-
sertion apparatus. The needle arrays were then heated to 98 ◦ C
for 5 min under the EM field by using the new treatment process.
The input current and power to the induction coils was about
1400 A and the total power of the system was about 35 kW.
After the treatment, the abdomen was carefully incised and the
ablation area on the liver was measured. After the surgery, the
abdomen was closed and the animal was kept under observation.
During the observation period, computed tomography (CT) im-
ages were taken on the pig liver to check the ablation area. After
the observation period, the animals were humanely sacrificed by
an anesthesia overdose and the liver was removed and processed
for further histological examinations.
III. RESULTS AND DISCUSSION
A. EM Field Measurements
The distribution of the EM field under the coils at different
positions was first explored since it is one of the most important
parameters for heat generation. Fig. 5 shows an effective range
of the EM field measured from −15 to 15 cm in x-axis (hori-
zontally) with a 1-cm increment and from 0 to 15 cm away from
the coil in y-axis (vertically) with a 3-cm increment. Note that
the effective range was defined as the EM field which could be
detected by the tesla meter. If the probe of the tesla meter was
placed outside the effective range, the tesla meter could only
read the environment value, which was not shown in the figure.
The total power of the EMS was about 35 kW, the input current
to the induction coils was about 1400 A, and the generated EM
field was measured by a tesla meter. In this study, the needle was
heated up to the high temperature under the EM field. For the
reason, we need to define an effective range (x–y plane) of the
EM field where the needle array can be placed and the EM field
intensity was high enough to heat up the needle to the high tem-
perature. Notably, the measurements were repeated five times
and the variation was about 3%. From the figure, the range in
602
Fig. 5. Curves of the intensity of the EM field at different positions measured
from −15 to 15 cm in x-axis (horizontally) and every 3 cm away from the coils
in z-axis (vertically). The input current to the induction coils was about 1400 A
and the total power of the system was about 35 kW.
TABLE I
EFFECTIVE RANGE OF EMF AT DIFFERENT DISTANCE AWAY FROM THE COILS
x-axis where the EM field could be measured—defined as the
effective range—was within the entire coils when the vertical
distance was less than 6 cm. The effective range of the EM field
in the x-axis decreased to 23 cm (from −11 to 12 cm) when
the vertical distance was 6 cm away from the coil. When the
tesla meter was moved to 9 cm away from the coil, the effective
range of the EM field was from −10 to 10 cm in the x-axis,
and continued to decrease to an even smaller range (from −8 to
9 cm and −7 to 7 cm in the X-axis) when the distance increased
to 12 and 15 cm. When no-touch isolation MIS was performed
under the ETS in the pig’s liver, the distance between the coil
and the magnetic section of the two-section needle was about
9 cm. Therefore, the needle arrays had to be placed in the effec-
tive range of the EM field (from −10 to 10 cm in the x-axis). It
also indicated that when different distance away from the coils
was used, the effective range of the EM field had to be checked
before the treatment. Table I lists the effective range of the EM
field at different distance.
B. Ablation Area of the Single Needle by Using
the New Treatment Process
Figs. 6 and 7 show the ablation area that the tissue would be
ablated of a single two-section needle under the ETS by using the
new treatment process with different internal shut-off times (0, 5,
10, 15, 20, 25, and 30 s, respectively) after the needle reached
98 ◦ C. Note that the ablation area was defined as the ablation
region measured from the distance away from the needle. It
IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, VOL. 61, NO. 2, FEBRUARY 2014
Fig. 6. Ablation area of the single needle under the ETS by using the new
treatment process with different internal shut-off times (0, 5, 10, 15, 20, 25, and
30 s, respectively). The feedback temperature control system was set as 98 ◦ C.
Fig. 7. Curve of the ablation area of the single needle under the ETS by using
the new treatment process with different internal shut-off times (0, 5, 10, 15, 20,
25, and 30 s, respectively). The feedback temperature control system was set as
98 ◦ C.
indicates that the ablation area could be significantly affected
by this internal shut-off time, since it may effectively enhance
the heat transfer from the heated needle. Otherwise, the tissue
around the needle may be overheated (carbonization) to limit
effective heating of surrounding tissue, as in the case of RFA.
The measurements were repeated five times and the variation
was about 7%. From the results, the width of the ablation area
without using internal shut-off time was about 5 mm away from
the needle (totally 10 mm). The ablation area increased to 6 mm
away from the needle (totally 12 mm) by using a 10 s internal
shut-off time but began to decrease with longer shut-off times
and eventually decreased to about 4 mm (totally 8 mm) away
from the needle at a 30 s internal shut-off time.
Note that without using new treatment process, the needle was
kept at 98 ◦ C during the entire treatment. The heat conduction
began to decrease when the humidity of the tissue decreased.
HUANG et al.: ELECTROMAGNETIC THERMOTHERAPY SYSTEM WITH NEEDLE ARRAYS
Fig. 8. Ablation area of the needle-array ablation under the ETS by using
the new treatment process. The distance between each needle was 1.0, 1.5, and
2.0 cm, respectively.
Therefore, the ablation area was limited to 5 mm away from the
needle. Alternatively, by using the new treatment process, the
needle was cooled down during the internal shut-off time. The
humidity of the ablation tissue could be recovered because water
could permeate back from the normal tissue around the ablated
tissue, which led to effective heat conduction and increased
ablation area. On the other hand, if the internal shut-off time
was longer than 10 s., there was more loss of heat and began
to reduce the ablation area. For the reason, the new treatment
process with a 10 s internal shut-off time was determined and
used in the in vitro needle-array ablation and the in vivo no-touch
isolation MIS for pigs.
C. In Vitro Needle-Array Ablation in the Porcine Liver
Fig. 8 shows the ablation area of a three-needle array under
the ETS by using the new treatment process. Experimental data
show that the surrounded area of the needle arrays could be
completely ablated when the distance between each needle was
1.0 and 1.5 cm. When the distance between each needle was
increased to 2.0 cm, the tissue between the needles could not be
completely ablated and therefore would reduce the effect of the
treatment. As mentioned earlier, the ablation of the single needle
under the ETS by using the new treatment process was about
12 mm. Combined with the new treatment process and the needle
array, the ablation area was further extended to 15 mm since
additional heating could be transferred from the neighboring
needles. By using the single needle ablation, the generated heat
was transferred to the surrounded tissue rapidly conductively
and convectively through the blood circulation. When using the
needle-array ablation, the generated heat would be effectively
locked in the area surrounding the needle array to cause the wider
ablation area. Therefore, the distance between each needle in the
needle-array insertion apparatus was designed to be 1.5 cm.
603
Fig. 9. Needles were inserted into a pig liver in vivo and heated under the
ETS. The distance between the magnetic part of the two-section needle and the
coils was 9 cm.
Fig. 10. Ablation area of the pig’s liver, which was measured to be about
30 mm 30 mm.
D. In Vivo MIS
In no-touch isolation MIS, the aim was to generate a wide ab-
lation area on the Lan-Yu pig’s liver by using the needle arrays
under the ETS with the new treatment process. Note that the
abdomen of the Lan-Yu pigs was not opened before the treat-
ment. Fig. 9 shows a photograph of the surgery site on the pig
after the needle insertion. After the insertion, the needle array
would be heated under the ETS to 98 ◦ C for 5 min by using the
new treatment process. The distance between the induction coil
and the magnetic section of the two-section needle was about
9 cm in this treatment. After the heating, the needles were all
removed without sticking to the normal tissue. Fig. 10 shows
the ablation area on the pig’s liver. The liver was successfully
ablated by the two-section needle arrays under the ETS and the
ablation area was measured to be about 35 mm × 25 mm. No
bleeding was observed around the wound when the needle was
retracted from the liver, indicating that the blood vessels around
the needle were successfully cauterized. It is noted that the nor-
mal tissue around the two-section needle was not damaged and
there was no inflammation observed after the treatment. After
the observation, the abdomen of the Lan-Yu pigs was closed.
One week after the treatment, the liver of the pig was imaged
by a CT scan. Fig. 11 shows the CT image of the pig’s liver.
The ablation area was shown in the upper right corner in each
604 IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, VOL. 61, NO. 2, FEBRUARY 2014
Fig. 11. CT image of the pig’s liver. The ablation area was the shadow area
in the upper side of the figure. In the CT, the ablation area was about 30 mm
30 mm.
Fig. 12. Remnant porcine liver two weeks after electromagnetic thermal
surgery. (a) Gross section shows a well-defined pale area of necrosis (N).
(b) Necrotic tissue (N) showed a homogeneous eosinophilic change of the
hepatocytes and blurring of original liver lobular architecture compared to the
viable tissue (V). (c) There is a fibrous band (F) between viable tissue (V) and
necrotic tissue (N). (B: H-E stain; C: Masson’s trichrome stain, 40×).
image and the ablation area was about 40 mm × 30 mm. The
ablation area on the CT image was wider than the observation
because some ablation area was embedded inside the liver. Two
weeks after the treatment, the animals were humanely sacri-
ficed by an anesthesia overdose and the remaining organ was
removed and processed for further histological examinations.
Notably, the cauterized tissue showed a well-defined pale area
of necrosis [Fig. 12(a)]. Microscopically, the pale area showed a
homogeneous eosinophilic change with blurring of original liver
lobular architecture, representing complete coagulative necrosis
[Fig. 12(b) and (c)]. There was a fibrous band between viable
tissue and necrotic tissue, indicating a healing process at the
edge of the cauterization area [Fig. 12(c)]. From the figure, the
tissue between each needle was completely ablated.
IV. CONCLUSION
This study has demonstrated a new treatment method for
achieving no-touch isolation MIS for ablation of pigs’ liver.
An ETS and a new treatment process have been developed and
demonstrated to be safe, efficient, and useful medical equipment.
The needle-array ablation treatment was further confirmed via
in vitro testing and in vivo animal test. Unlike the RFA and
the microwave ablation systems, there was no limitation in the
numbers of needles for the developed method, which enabled
a larger ablation area. The system could be applied for MIS to
treat tumors and could also be designed for large-range hemosta-
sis. Basically, there is no restriction on the number of needles
that can be used. If the needles were all placed in the effective
range of the EM field, every needle can be heated effectively
to the specific setting temperature and treat the target tumors.
The effective range of the EMF was based on the distance away
from the coils. In the clinical applications, the no-touch mini-
mal invasive treatment was used when the tumor size was under
3 cm. For the reason, to treat 3-cm tumor, 3–5 needles would
be used in the treatment. For larger tumors, we can use more
needles and then move the coils around. Note that the pain could
be induced when the needle was inserted and heated. For each
and every minimal invasive treatment, the pain may be induced
during the needle insertion process. The outer diameter of the
needle was less than 1.8 cm to minimize the pain during the
insertion. During the heating process, the temperature was also
controlled under 98 ◦ C to minimize the pain. The main limitation
of the developed technique was the range of the EM field in the
z-axis (depth). The effective depth of the system in this research
was 15 cm. It was deep enough to treat most of organs in the
common human body. However, if the patients were too fat, the
target organ may be deeper than 15 cm, which could be out
of the effective range of the EM field. To solve the problem,
a new synchronism system to increase the effective range to
40 cm is under investigation. The developed system and asso-
ciated treatment apparatus may become a promising tool for
MIS-based thermal ablation treatments in the near future.
ACKNOWLEDGMENT
The authors would like to thank the National Science Council
(NSC 101–2325-B-006–014) for partial financial support of this
project. They would also like to thank S.-Y. Chen, S.-F. Chen,
and K.-C. Chen for assisting with the minimally invasive surgery
on the animal models.
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605
Sheng-Chieh Huang received the B.S. and M.S. de-
grees from the Department of Engineering Science,
National Cheng Kung University, Taiwan. He is cur-
rently working toward the Ph.D. degree in the De-
partment of Power Mechanical Engineering, National
Tsing Hua University, Taiwan.
His research interests include biomedical en-
gineering, clinical research and its biomedical
applications.
Jui-Wen Kang received the M.D. degree from the
National Cheng Kung University, Taiwan.
He is a Physician in the Division of Gastroenterol-
ogy and Health Management Center, and an Active
Member of Innovation Center of Medical Devices
and Technology in the National Cheng Kung Univer-
sity Hospital. He is good at therapeutic endoscopy.
His current research is prevention of colorectal
cancer, including precancerous colorectal neoplasia
management.
Hung-Wen Tsai received the M.D. degree from the
National Cheng Kung University, Taiwan.
He received liver pathology training as a Visit-
ing Researcher in the Mount Sinai Medical Center,
New York. He is a Pathologist in the Department of
Pathology , National Cheng Kung University Medical
Center. His research interests include the pathology
of hepatocellular carcinoma and its carcinogenesis.
Yan-Shen Shan received the M.D. and Ph.D. degrees
from the National Cheng Kung University (NCKU),
Taiwan.
He is currently an Associate Professor of the In-
stitute of Clinical Medicine, NCKU, and the Chief
of the Division of Trauma, NCKUH. He is a na-
tionally recognized expert in hepatobiliary pancreatic
and gastrointestinal surgery and surgical oncology.
His current research interests include metastasis and
prognosis of cancer, inflammation and cancer, cancer
stem cells, surgical nutrition, surgical infection and
new technology in hepatobiliary pancreatic surgery.
Xi-Zhang Lin received the M.D. degree from the
National Taiwan University, Taiwan.
He is a Professor in the Department of Internal
Medicine, and a Physician specializing in gastroen-
terology, National Cheng Kung University Medical
Center, Tainan, Taiwan. He is famous in minimally
invasive therapy and therapeutic endoscopy. His cur-
rent research interests include treatment of hepatoma
by electromagnetic thermotherapy and by injectable
radioisotopes.
Gwo-Bin Lee received the B.S. and M.S. degrees
from the Department of Mechanical Engineering,
National Taiwan University, Taiwan, in 1989 and
1991, respectively, and the Ph.D. degree from the
Department of Mechanical and Aerospace Engineer-
ing, University of California, Los Angeles, USA, in
1998.
From August 1998 to January 2011, he was a
Faculty Member at the National Cheng Kung Uni-
versity. He is currently a Distinguished Professor in
the Department of Power Mechanical Engineering,
National Tsing Hua University, Hsinchu, Taiwan. He was elected as ASME
fellow in 2013. His current research interests include development of med-
ical electronic devices and integrated microfluidic systems for biomedical
applications.