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Yancheng Wang

Department of Mechanical Engineering,


University of Michigan,
Ann Arbor, MI 48109
Silicone-Based
e-mail: yancwang@umich.edu

Bruce L. Tai
Tissue-Mimicking Phantom
Department of Mechanical Engineering,
University of Michigan,
for Needle Insertion Simulation
Ann Arbor, MI 48109
e-mail: ljtai@umich.edu Silicone-based tissue-mimicking phantom is widely used as a surrogate of tissue for clini-
cal simulators, allowing clinicians to practice medical procedures and researchers to
Hongwei Yu study the performance of medical devices. This study investigates using the mineral oil in
Department of Mechanical Engineering, room-temperature vulcanizing silicone to create the desired mechanical properties and
University of Michigan, needle insertion characteristics of a tissue-mimicking phantom. Silicone samples mixed
Ann Arbor, MI 48109 with 0, 20, 30, and 40 wt. % mineral oil were fabricated for indentation and needle inser-
e-mail: yhongwei@umich.edu tion tests and compared to four types of porcine tissues (liver, muscle with the fiber per-
pendicular or parallel to the needle, and fat). The results demonstrated that the elastic
Albert J. Shih modulus and needle insertion force of the phantom both decrease with an increasing con-
Department of Mechanical Engineering, centration of mineral oil. Use of the mineral oil in silicone could effectively tailor the
University of Michigan, elastic modulus and needle insertion force to mimic the soft tissue. The silicone mixed
Ann Arbor, MI 48109; with 40 wt. % mineral oil was found to be the best tissue-mimicking phantom and can be
Department of Biomedical Engineering, utilized for needle-based medical procedures. [DOI: 10.1115/1.4026508]
University of Michigan,
Keywords: needle insertion, tissue-mimicking, silicone phantom, force, indentation
Ann Arbor, MI 48109
e-mail: shiha@umich.edu

1 Introduction similar to soft tissue [10] and is durable for needle insertion, was
utilized as the base material to fabricate the TM phantom.
Clinical simulators are commonly used for clinicians’ training
The mechanical properties of TM phantoms and soft tissues are
and the calibration or testing of medical devices since they can
usually measured by compression [11] or indentation [12] tests.
provide a similar environment to that of real medical procedures
The elastic modulus can be derived from the hardness reading of
[1]. Medical simulators are particularly important for training on
the indentation test. To use silicone as a TM phantom, it is impor-
needle-based procedures, which use needles, catheters, guide-
tant to have an elastic modulus similar to soft tissue. It is known
wires, and other small-bore instruments. It is a mandate that
that adding mineral oil into silicone can change the ultrasound
nurses and clinicians for all needle-based procedures need to be
image properties [13], while its effect on the mechanical proper-
trained using medical simulators [2]. To further advance the clini-
ties has not been studied. A goal of this research is using the in-
cal education using medical simulators, there is a great need to de-
dentation test to measure the elastic modulus of the RTV silicone
velop tissue-mimicking (TM) phantoms with needle insertion
with different concentrations of mineral oil and match it to that of
characteristics and mechanical properties similar to those of soft
various soft tissues.
tissues.
The needle insertion characteristics are determined by the nee-
Tissue-mimicking phantoms, which act as the surrogates of soft
dle insertion force. Abolhassani et al. [14] developed models for
tissue, are critical components of clinical simulators. They are
the needle insertion force and needle deflection. Gerwen et al.
usually made from either chemically synthesized polymer (CSP)
[15] reviewed the research on needle insertion into soft-tissue,
or biopolymer. Silicone [3] and polyvinyl chloride [4] are two
including the needle insertion force, effects of the insertion
major types of CSPs. Biopolymers, such as gelatin [5], agar [6],
method, needle tip geometry, and tissue properties. Okamura [16]
and gellan gum [7,8] typically include over 80% of water and
decomposed the needle insertion force into the stiffness (tissue
have a stiffness similar to that of soft tissue. However, biopoly-
elasticity), cutting (tissue toughness), and friction forces. The
mers have limited durability for needle insertion applications. In
stiffness force occurs prior to the puncture of the tissue; the cut-
comparison, a CSP is more durable, withstanding repeated needle
ting and friction forces take place after the needle breaks into the
insertions. Its wide range of mechanical properties and long-term
tissue. The force at the puncture point has been defined as the ini-
stability provide additional advantages over biopolymers [9]. Fur-
tial peak needle insertion force [17]. Using the elemental cutting
thermore, CSPs do not contain water and thus do not have the
tool concept, a model to predict the needle insertion force has
problems of evaporation or bacterial growth. A major drawback
been developed [17–19] and applied for optimal needle tip design
of CSPs is the lack of water as the lubricant during needle inser-
[20]. With the knowledge gained in the mechanics of soft tissue
tion. As a result, the resistive force for needle insertion into a CSP
needle cutting, this paper also uses the needle insertion force to
is usually higher than that of soft tissue. In this study, mineral oil
study the effect of the mineral oil concentration in the silicone.
was adopted as the lubricant to mix into the CSP to improve the
In this study, the RTV silicone-based TM phantom specimens
needle insertion characteristics. Room temperature vulcanizing
are fabricated with 0, 20, 30, and 40 wt. % mineral oil. The experi-
(RTV) silicone, which can be easily molded with a stiffness
mental setup and procedures to determine the elastic modulus and
needle insertion forces are first introduced. It is followed by the
Manuscript received February 27, 2013; final manuscript received January 6, analyses and comparisons between the TM phantoms and four
2014; published online March 7, 2014. Assoc. Editor: Carl A. Nelson. ex vivo porcine tissues: liver, muscle with the fiber perpendicular

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where mA and mB are the mass of Parts A and B, respectively, and
x is the weight ratio of the mineral oil.
The procedures used to fabricate the silicone-based phantoms
are described as follows: (1) mix Part A and mineral oil in a dry
container and stir at room temperature for 1 min, (2) add Part B
into the mixture and stir at room temperature for another 1 min,
(3) place the mixture in a vacuum chamber for 2 min to remove
air bubbles trapped inside the mixture, and (4) pour the final mix-
ture into the mold (see Fig. 1(a)) with the inside geometry of
35.0 mm in diameter and 20.0 mm in depth (see Fig. 1(b)). The sil-
icone cures in 24 h at room temperature. Samples of the silicone-
based TM phantom before and after demolding are shown in
Figs. 1(c) and 1(d), respectively. The thickness of the specimen is
20 mm, which is three times larger than the indentation depth
(6 mm). In this study, four types of silicone phantom with 0, 20,
30, and 40 wt. % mineral oil were fabricated.

2.2 Indentation Test for Measurement of Elastic Modulus.


The elastic modulus was measured by the indentation test, as
shown in Fig. 2(a), which is a common method to measure the
hardness of soft tissues [12,22,23]. The indentation test was per-
formed using a 000-S durometer (Instron, Norwood, MA) with a
10.67 mm radius spherical indenter (12.0 mm in width), as shown
in the close-up view in Fig. 2(b). The durometer was attached to a
Fig. 1 Molding of the TM silicone phantom: (a) plastic mold, linear stage (Siskiyou instruments Model 100cri, Grants Pass,
(b) mold internal geometry, (c) silicone phantom in the mold, OR) to control the depth of indentation. The specimens, including
and (d) a silicone phantom specimen after molding four silicone-based phantoms and fat and muscle specimens, were
held by a plate, as shown in Fig. 2(a). The liver was placed in a
or parallel to the needle, and fat. Finally, the results and discus- plastic mold (as shown in Fig. 1(a)); the round shape of the mold
sion are presented. provides a consistent boundary for the liver during indentation
test. The indenter was first moved to touch the phantom top
2 Materials and Methods surface. This is set as zero on the durometer dial, as shown in
Fig. 2(a). Then the linear stage moved the indenter into the phan-
2.1 Manufacture of the Silicone-Based TM Phantom. The tom specimen until the skirt of the durometer touched the top
silicone for this study is commercially available and fabricated by edge of the phantom, as shown in Fig. 2(c). The durometer
mixing two-part solutions, Parts A and B, from the manufacturer reading can be converted to the elastic modulus (E) using the
(Smooth-On Inc., PA). The composition of Part A is a mixture equation [8]
of polyorganosiloxanes (75–85 wt. %), amorphous silica
(20–25 wt. %), and platinum-siloxabe complex (0.1 wt. %). Part B ð1  t2 ÞF
consists of polyorganosiloxanes (65–70 wt. %), amorphous silica E ¼ pffiffiffi (2)
4 R  h3=2
(20–25 wt. %) and other proprietary ingredients (10 wt. %) [21].
Parts A and B were mixed at the ratio of 1:1 by weight. Mineral
where t is Poisson’s ratio, F is the spring force of the durometer,
oil (Comforts Baby Oil, OH) is added to adjust the mechanical
R is the radius of the sphere indenter, and h is the indentation
and tribological properties of the silicone. For a given wt. % of
depth. Silicone is assumed as roughly incompressible and has a
mineral oil in the TM phantom, the mass of the mineral oil (moil)
Poisson ratio of 0.49 [24]. Most soft tissues are also considered as
can be calculated by
incompressible materials and have a Poisson ratio value in the
xðmA þ mB Þ range of 0.45 to 0.49 [25]. A Poisson ratio of 0.49 was utilized for
moil ¼ (1)
1x all the tested specimens in this study.

Fig. 2 Indentation test for elastic modulus measurements: (a) before indenter compression, (b)
close up view of the indenter of the durometer, and (c) after indenter compression

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2.3 Needle Insertion Experiment. The experimental setup to
insert the needle into a phantom and measure the needle insertion
force is shown in Fig. 3. Two linear actuators (Siskiyou instru-
ments 200 cri and 100 cri) were assembled to create two orthogo-
nal motions (x-z) for targeting and inserting a stainless steel solid
trocar (1.01 mm diameter) with a 9.7 deg bevel angle three-plane
arrowhead into the silicone-based phantom and soft tissue
specimens. Instead of a hollow needle, a solid trocar was used to
simplify the comparison because the friction force only exists on
the outer surface. This trocar was secured via a screw inside a
1.30 mm diameter and 15 mm deep hole of an aluminum needle
holder, as shown in Fig. 3(a). The holder was fixed to the linear
stages. The length of the trocar protruding from the holder was
95 mm. During the needle insertion test, the specimen was moved
in the x and z directions to reach the target point. Once this posi-
tion is reached, the needle insertion was performed in the y direc-
tion. After each needle insertion, the specimen was rotated by
60 deg and the needle was inserted in the y direction to a new
location in the specimen.
The silicone specimen was placed inside a plastic specimen
holder, which was the mold used for molding the phantom with
holes on both ends, and clamped on a fixture. The whole setup
was mounted on the top of a piezoelectric force dynamometer
(Kistler Model 9256-C), as shown in Fig. 3(a). Figures 4(a) and
4(b) show the porcine tissue and silicone specimens inside the
holder, respectively. The specimen holder had two 10.0 mm diam-
eter center holes (see Fig. 4(c)). The needle penetrates through
these two holes in six locations, about 60 deg apart from each
Fig. 3 Needle insertion test experimental setup: (a) overview, other and 3.0 mm from the center.
(b) close up view of the trocar tip and the silicone specimen, The insertion test had four stages, including one complete inser-
and (c) shape of the specimen holder and specimen tion and three reciprocating motions to test the durability and fric-
tion force. First, the needle traveled 33 s (about 50 mm) into the
sample at a constant speed of 1.5 mm/s. After the 33 s insertion,
Based on the American Society for Testing and Materials the needle was retracted at a constant speed of 1.5 mm/s for 12 s
(ASTM) Standard D2240-05 [26], F (unit: N) and h (unit: m) can (18 mm). The trocar was then reciprocated for 12 s (at 1.5 mm/s)
be obtained from the 000-S durometer reading (H) based on the for three complete cycles. After these cycles, the trocar was pulled
relationship between the spring force and indentation depth out of the sample and returned to its initial position. Before needle
insertion, the needle surface was cleaned by ethanol and then
F ¼ 0:01765H þ 0:167 (3) dried for about one min to reduce the effect of lubrication. The
needle axial force was measured by the force dynamometer
and throughout the insertion cycles. The sampling rate was set at 1000
  samples per second; no filter was utilized to process the data. Six
H repeated insertion tests around the holder center were performed
h ¼ 0:005 1  (4)
100 on one sample for each type of specimen, as shown in Fig. 4(c).
The specimens were tested in sequence: four types of silicone
where 0.005 is the extension length of the indenter and 100 is the phantoms with 0, 20, 30, and 40 wt. % mineral oil and four por-
maximum of the dial reading. cine tissues (fat, liver, and muscles (perpendicular and parallel to
Four types of silicone phantoms with 0, 20, 30, and 40 wt. % the fiber orientation)).
mineral oil and four types of porcine tissues (fat, liver, and
muscles (perpendicular and parallel to the fiber orientation)) were 3 Results and Discussion
measured for comparison. The indentation test was repeated four
times at the same point for each specimen. The time between each 3.1 Elastic Modulus. Table 1 summarizes the elastic modu-
test was about 2 min to release the loading stress. lus of four silicone and four porcine tissue specimens. The

Fig. 4 Test specimens in the holder (a) muscle perpendicular to the fiber, (b) silicone speci-
men, and (c) schematic view of the six needle insertion positions in the specimen holder

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Table 1 Elastic modulus of TM phantom and tissue samples

Elastic modulus (kPa)

Hardness Standard
reading Average deviation

Silicone with 0% 56.5 21.3 0.6


mineral oil 20% 46.0 13.0 0.5
30% 41.0 10.4 0.2
40% 40.8 10.3 0.2
Porcine Fat 37.5 8.9 0.2
tissue Muscle perpendicular 45.5 12.7 1.3
to the fiber
Muscle parallel 43.2 11.5 1.2
to the fiber
Liver 42.2 11.0 0.7

hardness reading of the tested phantoms for the 000-S durometer


Fig. 5 Needle insertion forces for silicone with 0% mineral oil
ranged from 40 to 57, corresponding to an elastic modulus of 10.3
to 21.3 kPa. For the porcine tissues, the hardness ranged from 37
to 47, which corresponds to an elastic modulus of 8.9 to 12.7 kPa.
The low standard deviation (0.2 to 1.3 kPa) indicates good repeat- Phase III: after the first full insertion, the needle was retracted
ability of the indentation measurements for both silicone and at 1.5 mm/s for 12 s (18 mm) and then advanced again for 12 s
tissue specimens. (18 mm). In this phase, the needle shaft remained in full contact
In Table 1, the silicone without mineral oil has the largest elas- with the tissue with no tissue cutting taking place; thus, during
tic modulus (21.3 kPa). As the wt. % of the mineral oil increases, this phase only the friction force exists between the phantom and
the elastic modulus is reduced, although no significant change is needle shaft. The negative and positive forces in Phase III corre-
observed when the mineral oil content is over 30 wt. %. The spond to the needle insertion directions. Due to the deformation of
explanation is that the mineral oil at 40 wt. % has reached the the specimen, there exists a transition region (at 0
about 10 s or
saturation point of the silicone phantom. When adding more than 15 mm) before the friction forces, denoted as FIII f and FIII
f , occur
40 wt. % mineral oil into silicone, the mineral oil can hardly to be in the plateau region. Compared to Phase II, the friction forces are
absorbed completely. For soft tissues, fat and liver have lower lower in Phase III, possibly because the surface in contact with
elastic moduli (8.9 and 11.0 kPa, respectively), while the muscle the needle shaft has been smoothed after the first insertion in
perpendicular to the fibers has the highest elastic modulus Phase II.
(12.7 kPa). For a given indentation depth, muscle perpendicular to Phases IV and V: the same needle insertion0 cycle as in Phase
the fiber generates a higher force against the indenter; thus it has a III was repeated twice. The friction forces (FIV f and FIV
f ) in Phase
V0 0
higher elastic modulus compared to that of muscle parallel to the IV and (Ff and Ff ) in Phase V gradually decrease from FIII
V
f and
III
fiber [23]. In summary, increasing the mineral oil to between 20 Ff in Phase III. The hole created by the needle in the phantom
and 40 wt. % can provide silicone with a proper elastic modulus to expands and the inner surface in contact with the needle possibly
mimic porcine tissues. becomes smoother after each cycle. The change of the friction
force through Phases III, IV, and V is related to the phantom
3.2 Needle Insertion Force. Figure 5 shows an example of durability.
the measured needle insertion force for silicone with 0% mineral Phase VI: the needle was retracted to the initial position after
oil during the cyclic insertion test. From the force curve, approxi- three repeated cycles.
mately six general phases (Phases I–VI presented in the following Figures 6 and 7 show the results of the needle insertion force
text) correspond to the needle insertion at different stages. over time for four silicone and four porcine tissue specimens,
Phase I: the needle insertion force starts to increase when the respectively. In Fig. 6, the silicone specimens exhibit very repeat-
needle tip deforms the phantom, eventually breaking into the able results, indicating the consistency of this material for clinical
phantom, and ends at the peak force corresponding to the needle simulator applications. The silicone specimen without mineral oil
tip penetrating out from the specimen. Before puncturing the tis- has the highest insertion force. The effect of the mineral oil con-
sue, the needle insertion force increases as the phantom deflection centration on the insertion force is similar to that imposed on the
increased. The force when the needle tip breaks into the tissue is hardness and elastic modulus. With the increase of the mineral oil
the initial needle insertion force [19], which may not be clearly percentage, the needle insertion force is reduced.
defined on the force curve, depending on the material properties. In Fig. 7, soft tissue specimens exhibit a larger discrepancy of
After the needle puncture into the tissue, the needle insertion force force in six repeated tests due to the inherent variation in the tis-
becomes the sum of the cutting force and friction force along the sue. Compared to Fig. 6, the silicone with 40 wt. % mineral oil
needle tip and shaft. The cutting force at the needle tip includes has the insertion force closest to that of soft tissues, which ranges
the force generated by the wedging actions of the needle tip. The from 0.4 to 1.0 N. Needle insertion into the muscle perpendicular
peak force at Point A (shown in Fig. 5) can be decomposed into to the fiber requires the highest force while liver requires the
the cutting force (Fc) and friction force (Ff). lowest.
Phase II: after the needle penetrates out of the phantom, the
insertion force decreases to a certain level while the needle is still 3.3 Force Components During Needle Insertion. The nee-
moving forward. Only the friction force exists in this phase since dle insertion force, denoted as F, consists of both a cutting force
no cutting occurs. The average force in the last 6.7 s (about 10 mm (Fc) and a friction force (Ff). Researchers have attempted to
needle insertion, from points B to C in Fig. 5, defined as the fric- decompose Fc and Ff using either two load cells to acquire the Fc
tion force in Phase II (FIIf ). The force in the last 10 mm of needle and F individually [27] or two repeated needle insertions to distin-
insertion reaches a more steady-state level. The cutting force (Fc) guish the Ff in the second insertion from the first insertion with
was obtained by subtracting FIIf from the peak force at Point A. the combination of Fc and Ff [16,28]. The second approach is

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Fig. 6 Needle insertion force versus time for four silicone specimen with: (a) 0, (b)
20, (c) 30, and (d) 40 wt. % mineral oil

Fig. 7 Needle insertion force versus time for four types of porcine soft tissue: (a)
fat, (b) muscle perpendicular to the fiber, (c) muscle parallel to the fiber, and (d) liver

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Fig. 9 The degradation of (a) forward, and (b) backward fric-
tion forces throughout five phases for six repeated needle
insertion
Fig. 8 Average and standard deviation of the force compo-
nents of (a) silicone specimens, and (b) porcine ex vivo tissues
for six repeated needle insertion silicone phantom is higher but still closest to that of fat (0.45 N).
Although the F, Fc, and Ff of the silicone with 40 wt. % mineral
oil does not perfectly match those of porcine tissue, its needle
adopted in this study. The Fc was determined by subtracting Ff insertion properties are close to those tissues and will be suitable
from the peak insertion force (at Point A in Fig. 5) when the nee- for clinical simulator applications. The variations among the por-
dle has fully penetrated through the entirety of the specimen. The cine soft tissue likely come from the differences in their material
Ff was measured in Phase II when the needle tip has moved out- properties. Fat has the largest F and Fc, due to its higher toughness
side the tissue, which is marked as FIIf in Fig. 5. The friction forces and lubricity. Liver has the lowest Ff, likely due to the high ratio
during the rest of the cycles are not considered characteristic of of water content to lubricate the needle insertion. Muscle perpen-
the force for comparison; instead, its consistency over time indi- dicular to the fiber has a higher Fc and Ff than that of muscle par-
rectly represents the durability of the phantom under repeated allel to the fiber because of the strong support against needle
insertions (as discussed further in Sec 3.4). insertion that the fiber generates.
Figure 8 shows average and standard deviation of the F, Fc, and
Ff for eight specimens (four silicone phantoms and four types of 3.4 Durability Under Repeated Insertions. Durability is
porcine tissue) and six repeated needle insertion tests for each defined by the phantom material’s ability to maintain the same
sample. For the silicone phantoms, as shown in Fig. 8(a), the min- level of insertion force for repeated use. The results from recipro-
eral oil has a significant effect on reducing the F and Ff and a lim- cating needle insertions for each test reflect the durability of the
ited effect on the Fc. This follows our expectations because silicone phantom. As shown in Fig. 6, the decrease in the friction
mineral oil enhances the lubricity of the phantom, resulting in the forces (FIIf to FV
f ) over time can be attributed to the combination
reduced friction force and peak force. The silicone without min- of the improved surface roughness and lubrication and expansion
eral oil (0%) has a higher F than all of the other tested phantoms of the hole. The initial drop in force (FIIf to FV
f ) is relatively signif-
and tissues. The constant Fc (about 0.7 to 0.9 N) for the four sili- icant as a result of the lubrication added to the needle surface.
cone phantoms implies the same toughness against cutting regard- Since silicone with 40 wt. % mineral oil is the best candidate for
less of the mineral oil concentration. mimicking the soft tissue, Fig. 9 summarizes the change of fric-
Figure 8(b) shows the comparison of F, Fc, and Ff of four types tion forces for this silicone phantom and four types of porcine tis-
of porcine tissues and the silicone with 40 wt. % mineral oil. The sues. The forward and backward average and standard deviation
Ff of this silicone phantom (0.34 N) is between the muscle parallel of the friction forces are displayed in Figs. 9(a) and 9(b),
to the fiber (0.40 N) and liver (0.27 N). The Fc (0.58 N) of this respectively.

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