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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 post-treatment relapses. The similar techniques could be applied
tumor. In recent years, electromagnetic thermotherapy (EMT) has for resection of other organs. However, the hollow organs, such
been extensively investigated and holds the potential for a variety as gut, ureters, and bladders, are not the target applications for
of medical applications including for cancer treatment when com-
bined with minimally invasive surgery approach. In this study, an
this technology because the resected ends are usually resutured
alternating electromagnetic frequency was provided by an EMT together. If the resutured (anastomotic site) areas have necrotic
system to heat up stainless steel needle arrays which were inserted tissues remained, the suture usually cannot heal, and usually
into the target tumor to a high temperature, therefore leading to results in the leakage of the gut. In this method, physicians first
local ablation of the tumor. A new two-section needle-array appara- either remove or induce necrosis in the normal tissue around
tus was further demonstrated to encompass the tumor to prevent the tumor to isolate the tumor and then treat the target tumor
the tumor cells to spread after the treatment process. By using
the needle-array insertion apparatus, there is no limitation of the by chemotherapy or thermotherapy [4]–[6]. Thermal ablation
treatment area; this method could, therefore, be applied for tumors has also been a popular method for cancer treatment since its
that are larger than 6 cm. It was first successfully demonstrated advent. This method involves rapidly and locally heating the
in the in vitro experiments on porcine livers. Then an in vivo ex- tumor to above 60 ◦ C to cause necrosis of tumor cells. It is a
periment was directly conducted on pigs. The two-section needle simple therapy with few side effects and complications. In re-
array incorporated with the needle-array apparatus and EMT was
demonstrated to be promising for no-touch isolation treatment of
cent years, thermal ablation has been combined with minimally
cancerous tumors. invasive surgery (MIS) [7], [8] as a new approach for treating
cancer. For example, radio-frequency ablation (RFA) [9], [10],
Index Terms—Ablation, electromagnetic thermotherapy (EMT)
microwave ablation [11], [12], and electromagnetic thermother-
system, encompassing treatment, minimally invasive surgery
(MIS), needle arrays. apy (EMT) [13]–[16] have been applied in a variety of cancer
treatments such as organ resection surgery [17] and necrosis of
I. INTRODUCTION tumor cells in internal medicine [18]. RFA employs a probe that
FFECTIVE treatments for cancer can significantly reduce passes an alternating electric current with a frequency ranging
E the mortality of this deadly disease. Among the devel-
oped methods, no-touch isolation treatment [1]–[3] has been
from 460 to 500 kHz through the target region in the tissue and
rapidly and efficiently raises the local temperature to 90–110 ◦ C
broadly applied because it prevents tumor cells to spread from to cause tissue ablation [19]. Alternatively, microwave ablation
the tumor after the treatment and therefore effectively prevents 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
Manuscript received June 29, 2013; revised August 18, 2013 and September no-touch isolation treatment, however, is challenging because
18, 2013; accepted October 4, 2013. Date of publication October 23, 2013; date RFA and microwave probes are expensive and the number of
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 probes that could be simultaneously applied during treatments
indicate corresponding authors. is, thus, limited to two to four probes [20], [21].
S.-C. Huang is with the Department of Power Mechanical Engineering, Alternatively, EMT has been extensively explored recently
National Tsing Hua University, Hsinchu 30013, Taiwan (e-mail: xaviersty@
hotmail.com).
and has been shown to be an effective tool for local thermal
J.-W. Kang is with the Department of Internal Medicine, National ablation. The EMT system is usually equipped with induction
Cheng Kung University, Tainan City 704, Taiwan (e-mail: pete1594@ coils to generate a high-frequency electromagnetic field (EM
yahoo.com.tw). field). When a magnetic material (such as a needle or seeds) is
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). placed under the EM field, it generates significant heat due to
Y.-S. Shan is with the Department of Surgery, National Cheng Kung Univer- the eddy current and the hysteresis energy loss [22]. Note that
sity, Tainan City 704, Taiwan (e-mail: ysshan@mail.ncku.edu.tw). the eddy current only exists on the surface of the magnetic ma-
∗ 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). terials (needles) under the EMT. There is no eddy current in the
∗ G.-B. Lee is with the Department of Power Mechanical Engineering, body. Therefore, the eddy current may not cause neuromuscular
National Tsing Hua University, Hsinchu 30013, Taiwan (e-mail: gwobin@ stimulation. During the experiments, no neuromuscular stimu-
pme.nthu.edu.tw).
Color versions of one or more of the figures in this paper are available online lation was observed. With this approach, the no-touch isolation
at http://ieeexplore.ieee.org. treatment could be effectively achieved since there is no limita-
Digital Object Identifier 10.1109/TBME.2013.2285233 tion in the number of needles placed under the induction coils of

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.
HUANG et al.: ELECTROMAGNETIC THERMOTHERAPY SYSTEM WITH NEEDLE ARRAYS 599

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 Fig. 1. Schematic diagram of the developed ETS used for noncontract isolation
completely encompassed by the needles to achieve effective no- treatment.
touch isolation treatments. Therefore, a needle-array insertion
apparatus is of great need to control the distance between each which was used to prevent rapid rises of the needle temperature
needle and the arrangement of the needle insertion. Second, the under the EM field and maintain the treatment temperature at a
number of needles used during treatments needs to be optimized preset value with a variation of less than 1 ◦ C [17]. The temper-
so that the pain induced by the needles during the treatment can ature control system, which controlled the heating rate at 1 ◦ C/s,
be minimized while still attaining sufficient tumor coverage. also helped prevent needles that were withdrawn from the target
A new treatment process was, thus, explored in this study. It tissue from sticking to the tissue and the laceration. Fig. 1 shows
increased the ablation area of each needle such that the num- a schematic diagram of the ETS. The total power consumption
ber of the two-section needles used during the treatment—and of the system was about 35 kW, which was about 130% higher
hence the pain experienced by the patient—could be reduced. than the model previously developed by Shan et al. [17]. Note
As a demonstration, two-section needle arrays were inserted that the electric current was amplified to about 1400 A as the
into porcine livers to perform a no-touch isolation tissue abla- input to the induction coils. The operating frequency was about
tion without opening the abdomen. There are two major novel 44 kHz when used 30-cm-diameter coils. To prevent electric
aspects in this study. First, the needles were heated by the EM damage, the induction coils were coated with teflon for insula-
field under the coils. Therefore, there is no limitation of the tion. The ETS is a noncontact treatment; that is, electric current
numbers of the needles in the treatment and large-range tumors does not flow through the human or animal body during the
(more than 3 cm in diameter) can be treated at the same time. treatment, which is different from RFA. The hysteresis energy
It is the main novelty of the study. Second, the structure of the loss and eddy currents were generated when the magnetic ma-
two-section needle is relatively simple such that it is relatively terial was placed under the high-frequency EM field. Since the
cheap when compared with these existing probes. current flows through the coils and the magnetic field genera-
The intensity of the EM field was found to decrease when tor, significant EM field is generated accordingly to raise the
the needles were placed away from the induction coils [17]. The temperature of the needle over 100 ◦ C during the treatment. The
distance away from the coils may affect the effective range of the heat generated from the system could raise the temperature of
EM field to heat the needle arrays accordingly. The distribution 40 L of water from 26 to 50 ◦ C in 8 min. It is estimated that
of the effective EM field was, therefore, explored in this work. about 120 kcal needs to be removed from the induction coils and
Moreover, two experiments were conducted to demonstrate its the generator per minute. Therefore, a cooling system is used
capability, including in vitro and in vivo animal experiments. to keep the temperature of the coils and the generator at safe
The in vitro results showed that the developed apparatus and the temperature of 25–30 ◦ C.
new therapy progress could successfully cause wider ablation of
the target tissue with fewer needles. The results from the animal
B. Two-Section Needle for MIS
experiments showed that the livers of pigs were also successfully
ablated by using the needle arrays and the new therapy progress. The two-section needle is a specifically designed apparatus
The developed EMT system and no-touch isolation treatment for the no-touch isolation treatment. The schematic diagram of
process may provide a useful tool for removal of cancerous the two-section needle is shown in Fig. 2. It was composed
tumors. of a main needle and a secondary needle, both of which were
comprised of two sections. The upper 9-cm section of these two
II. MATERIALS AND METHODS needles was made of ceramic (a nonmagnetic material) for com-
ing into contact with the normal tissue such as skin or muscle
A. Hardware
during MIS. The ceramic, nonmagnetic section of the needle
1) Electromagnetic Thermotherapy System: As depicted in would not be heated under the EM field, which prevents the
Fig. 1, the electromagnetic thermotherapy system (ETS) con- normal tissues from being ablated and damaged by the inserted
sisted of a power supply (input: 380 V, 13 A, 60 Hz), a high- needle. The lower 3-cm section of both needles was designed to
frequency EM field generator equipped with induction coils with be inserted into the target tissue and was, therefore, made of a
a diameter of 30 cm (HP-Cube-35 kW, President Honor Indus- magnetic material (304-stainless steel). When placed under the
tries, Taiwan), a cooling system (CW-36, Wexten Precise Indus- EM field, the lower section of the needles would be heated to a
tries, Taiwan) and a custom-made temperature control module, specifically set temperature to cause ablation of the target tissue.
600 IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, VOL. 61, NO. 2, FEBRUARY 2014

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 Fig. 3. (a) (Top) Photograph of the main needle and (bottom) the secondary
between the magnetic part and the nonmagnetic part in the secondary needle. needle. (b) Main needle was assembled with the secondary needle inside.

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 Fig. 4. Schematic diagram of the needle-array insertion apparatus. It was
hollow needle since the lower section was made of magnetic composed of five rotation shafts with predesigned needle insertion holes.
materials. The heating effect was based on the mass of the mag-
netic materials. When the mass of the needle was increased, the and the needle arrays treatment; when the distance between
heating effect was improved accordingly. During the heating each needle was 1.5 cm, the tissue would be ablated completely.
process, the secondary needle was inserted into the main nee- During the needle insertion process, a needle that contains a
dle. Both the first and the second needles were heated under the temperature sensor would be first inserted into the target tissue
electromotive force (EMF). More importantly, a thermocouple under ultrasonic guidance [17]. The needle insertion apparatus
(K-type, InterTech Technology, Inc., Taiwan) could be buried was then aligned with the temperature-monitoring needle by us-
inside the secondary needle for monitoring the temperature of ing an alignment mark located on the middle rotation shaft. The
the needle during the treatment in real time. Note that the depth insertion angle of the other needles on the same shaft could be,
of the inserted needles could be also adjusted because distance therefore, adjusted to be aligned with the insertion angle of the
marks have been made on the needles and the physician can temperature-control needle. The angle of each rotation shaft can
read the distance mark to know the depth of the magnetic part be further adjusted such they could be aligned with the middle
of the needle in the tissue. Fig. 3(a) shows a photograph of the rotation shaft. Finally, the needles can be inserted according to
main needle and the secondary needle while Fig. 3(b) shows a the shape of the target tumor.
photograph of an assembled needle.
D. Animal Model
C. Needle-Array Insertion Apparatus Lan-Yu pigs were maintained at the animal center of the
The no-touch isolation treatment for MIS could be demon- National Cheng Kung University (NCKU) under humane con-
strated by using needle arrays under the EM field. A needle-array ditions and in accordance with the animal-care guidelines set
insertion apparatus was designed to precisely control the ar- forth by the Agriculture Council of Taiwan. Before the no-touch
rangement of the needles and the distance between each needle. isolation MIS, the pigs were anesthetized with intramuscular
Fig. 4 shows the schematic diagram of the needle-array insertion injection of 0.02 mg/kg atropine (Sintong, Taoyuan, Taiwan),
apparatus, which consists of five rotation shafts. Each rotation 2 mg/kg xylazine (Bayer, Leverkusen, Germany), and 10 mg/kg
shaft has five needle insertion holes. The distance between each Zoletil (Virbac, Carros, France). Following endotracheal intu-
needle insertion hole was 1.5 cm. The selected distance was bation, the animals received 1–3% isoflurane at 200 ml/kg/min
based on the results acquired from the new treatment process (Bexter, Guayama, USA) throughout the operation. The pigs
HUANG et al.: ELECTROMAGNETIC THERMOTHERAPY SYSTEM WITH NEEDLE ARRAYS 601

were observed for two weeks after the treatment. During the 3) In Vitro Test by Using the Needle Arrays: The distance be-
observation period, the health of the pigs was monitored daily. tween each needle plays an important role for the no-touch iso-
After the observation period, their livers were promptly removed lation MIS thermal ablation surgery. In order to ensure that the
and processed for further histological examinations and the pigs area encompassed by the needle array was completely ablated
were sacrificed by an overdose of anesthesia. 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-
E. Experimental Setup
tances between each needle. Because the effective ablation area
1) Distribution of the EM Field: The intensity, and hence the of a single needle under the EM field was about 1.0 cm [17], three
effective range, of the EM field is determined by the distance different distances, including 1.0, 1.5, and 2.0 cm were chosen
from the coils. In the study, the no-touch isolation MIS would for testing. After needle insertion, the needle arrays were heated
be demonstrated when the lower section of the needle (heating up to 98 ◦ C under the EM field for 5 min, which was determined
part) was placed 8–12 cm away from the coils, because of the to be an effective time period for EMS [17]. In order to observe
average distance between the skin and the target tissue in the the ablation area, the porcine liver was incised right after the
liver was 8–12 cm in the human. To make sure that all needles heating and the ablation area was measured accordingly.
could be heated up to the set temperature, the distribution of the 4) In Vivo Animal Testing: No-touch isolation MIS was per-
EM field was first explored. In this experiment, the intensity of formed on three Lan-Yu pigs. As mentioned previously, the
the EM field which was generated by the ETS was measured temperature-control needle was first inserted into the pig liver
by a tesla meter (model 7010, SYPRIS, USA). The sensor was under ultrasonic guidance. The needle-array insertion apparatus
placed at different positions from −15 to 15 cm in the x-axis was then aligned with the temperature-monitoring needle. Fi-
(across the coils) on the x–y plane across the coils and every nally, the other four needles were inserted into the liver around
3 cm away from the coils in z-axis (vertically) (x-, y-, and z-axis the temperature-monitoring needle through the needle-array in-
were schematically shown in Fig. 1). Note that there is no any sertion apparatus. The needle arrays were then heated to 98 ◦ C
EM field performance changes between the air and the tissue for 5 min under the EM field by using the new treatment process.
because the intensity of the EM field would not change in the The input current and power to the induction coils was about
nonmagnetic material. It only changed in the magnetic materials. 1400 A and the total power of the system was about 35 kW.
Since the tissue is the nonmagnetic materials, the results for EM After the treatment, the abdomen was carefully incised and the
field measurement in the air may provide important information ablation area on the liver was measured. After the surgery, the
for effective heating. abdomen was closed and the animal was kept under observation.
2) New EMT Process: In traditional EMT, the target tissue During the observation period, computed tomography (CT) im-
is typically heated directly to a specified temperature and main- ages were taken on the pig liver to check the ablation area. After
tained the temperature of the needle to the end of the treatment. the observation period, the animals were humanely sacrificed by
A new treatment process for EMT was developed in this work an anesthesia overdose and the liver was removed and processed
for increasing the ablation area of the needle under the EM for further histological examinations.
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 III. RESULTS AND DISCUSSION
98 ◦ C. Totally, six different internal shut-off times (including 5,
10, 15, 20, 25, and 30 s) were tested while compared with a A. EM Field Measurements
base-line case, which no shut-off time treatment process was The distribution of the EM field under the coils at different
referred. Note that during the internal shut-off time, the whole positions was first explored since it is one of the most important
system was turned OFF. The needle was first inserted into the parameters for heat generation. Fig. 5 shows an effective range
porcine liver and heated to 98 ◦ C under the EM field by using of the EM field measured from −15 to 15 cm in x-axis (hori-
the new treatment process with different internal shut-off time. zontally) with a 1-cm increment and from 0 to 15 cm away from
After the heating, the porcine liver was incised and the ablation the coil in y-axis (vertically) with a 3-cm increment. Note that
area was measured. Note that the key point to prevent excessive the effective range was defined as the EM field which could be
dehydration and maintain good thermal conductivity was the detected by the tesla meter. If the probe of the tesla meter was
setting temperature of the temperature control module. From placed outside the effective range, the tesla meter could only
our previous work [17], if the needle was heated under the EM read the environment value, which was not shown in the figure.
field without temperature control, the temperature of the needle The total power of the EMS was about 35 kW, the input current
may be heated over 150 ◦ C and the tissue around the needle to the induction coils was about 1400 A, and the generated EM
would be carbonized. The burn black tissue would decrease the field was measured by a tesla meter. In this study, the needle was
thermal conductivity to reduce the ablation area of the needle. heated up to the high temperature under the EM field. For the
On the other hand, if the temperature of the needle was too low reason, we need to define an effective range (x–y plane) of the
(less than the setting temperature), the ablation area would not EM field where the needle array can be placed and the EM field
cover the tumor and therefore the treating effect was decreased intensity was high enough to heat up the needle to the high tem-
accordingly. Therefore, the temperature control was crucial in perature. Notably, the measurements were repeated five times
this study. and the variation was about 3%. From the figure, the range in
602 IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, VOL. 61, NO. 2, FEBRUARY 2014

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 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.

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 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,
9 cm and −7 to 7 cm in the X-axis) when the distance increased 25, and 30 s, respectively). The feedback temperature control system was set as
to 12 and 15 cm. When no-touch isolation MIS was performed 98 ◦ C.
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- indicates that the ablation area could be significantly affected
tive range of the EM field (from −10 to 10 cm in the x-axis). It by this internal shut-off time, since it may effectively enhance
also indicated that when different distance away from the coils the heat transfer from the heated needle. Otherwise, the tissue
was used, the effective range of the EM field had to be checked around the needle may be overheated (carbonization) to limit
before the treatment. Table I lists the effective range of the EM effective heating of surrounding tissue, as in the case of RFA.
field at different distance. 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
B. Ablation Area of the Single Needle by Using
the needle (totally 10 mm). The ablation area increased to 6 mm
the New Treatment Process
away from the needle (totally 12 mm) by using a 10 s internal
Figs. 6 and 7 show the ablation area that the tissue would be shut-off time but began to decrease with longer shut-off times
ablated of a single two-section needle under the ETS by using the and eventually decreased to about 4 mm (totally 8 mm) away
new treatment process with different internal shut-off times (0, 5, from the needle at a 30 s internal shut-off time.
10, 15, 20, 25, and 30 s, respectively) after the needle reached Note that without using new treatment process, the needle was
98 ◦ C. Note that the ablation area was defined as the ablation kept at 98 ◦ C during the entire treatment. The heat conduction
region measured from the distance away from the needle. It began to decrease when the humidity of the tissue decreased.
HUANG et al.: ELECTROMAGNETIC THERMOTHERAPY SYSTEM WITH NEEDLE ARRAYS 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. 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 Fig. 10. Ablation area of the pig’s liver, which was measured to be about
to reduce the ablation area. For the reason, the new treatment 30 mm 30 mm.
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 D. In Vivo MIS
isolation MIS for pigs.
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
C. In Vitro Needle-Array Ablation in the Porcine Liver abdomen of the Lan-Yu pigs was not opened before the treat-
Fig. 8 shows the ablation area of a three-needle array under ment. Fig. 9 shows a photograph of the surgery site on the pig
the ETS by using the new treatment process. Experimental data after the needle insertion. After the insertion, the needle array
show that the surrounded area of the needle arrays could be would be heated under the ETS to 98 ◦ C for 5 min by using the
completely ablated when the distance between each needle was new treatment process. The distance between the induction coil
1.0 and 1.5 cm. When the distance between each needle was and the magnetic section of the two-section needle was about
increased to 2.0 cm, the tissue between the needles could not be 9 cm in this treatment. After the heating, the needles were all
completely ablated and therefore would reduce the effect of the removed without sticking to the normal tissue. Fig. 10 shows
treatment. As mentioned earlier, the ablation of the single needle the ablation area on the pig’s liver. The liver was successfully
under the ETS by using the new treatment process was about ablated by the two-section needle arrays under the ETS and the
12 mm. Combined with the new treatment process and the needle ablation area was measured to be about 35 mm × 25 mm. No
array, the ablation area was further extended to 15 mm since bleeding was observed around the wound when the needle was
additional heating could be transferred from the neighboring retracted from the liver, indicating that the blood vessels around
needles. By using the single needle ablation, the generated heat the needle were successfully cauterized. It is noted that the nor-
was transferred to the surrounded tissue rapidly conductively mal tissue around the two-section needle was not damaged and
and convectively through the blood circulation. When using the there was no inflammation observed after the treatment. After
needle-array ablation, the generated heat would be effectively the observation, the abdomen of the Lan-Yu pigs was closed.
locked in the area surrounding the needle array to cause the wider One week after the treatment, the liver of the pig was imaged
ablation area. Therefore, the distance between each needle in the by a CT scan. Fig. 11 shows the CT image of the pig’s liver.
needle-array insertion apparatus was designed to be 1.5 cm. 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. 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
Fig. 11. CT image of the pig’s liver. The ablation area was the shadow area
range of the EM field, every needle can be heated effectively
in the upper side of the figure. In the CT, the ablation area was about 30 mm to the specific setting temperature and treat the target tumors.
30 mm. 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
Fig. 12. Remnant porcine liver two weeks after electromagnetic thermal MIS-based thermal ablation treatments in the near future.
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 ACKNOWLEDGMENT
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×). 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,
image and the ablation area was about 40 mm × 30 mm. The
and K.-C. Chen for assisting with the minimally invasive surgery
ablation area on the CT image was wider than the observation
on the animal models.
because some ablation area was embedded inside the liver. Two
weeks after the treatment, the animals were humanely sacri-
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