sensors

Article

Fabrication of a Micro-Needle Array Electrode by

Thermal Drawing for Bio-Signals Monitoring
Lei Ren, Qing Jiang, Keyun Chen, Zhipeng Chen, Chengfeng Pan and Lelun Jiang *
Guangdong Provincial Key Laboratory of Sensor Technology and Biomedical Instrument,
Sun Yat-Sen University, Guangzhou 510006, China; rlei@mail2.sysu.edu.cn (L.R.); jqing@mail.sysu.edu.cn (Q.J.);
yunzibetterlife@163.com (K.C.); tiaopiji@icloud.com (Z.C.); panchf@mail2.sysu.edu.cn (C.P.)
* Correspondence: jianglel@mail.sysu.edu.cn; Tel.: +86-20-3933-2153
Academic Editor: Vittorio M. N. Passaro
Received: 21 April 2016; Accepted: 19 May 2016; Published: 17 June 2016

Abstract: A novel micro-needle array electrode (MAE) fabricated by thermal drawing and coated with
Ti/Au film was proposed for bio-signals monitoring. A simple and effective setup was employed to
form glassy-state poly (lactic-co-glycolic acid) (PLGA) into a micro-needle array (MA) by the thermal
drawing method. The MA was composed of 6 6 micro-needles with an average height of about
500 m. Electrode-skin interface impedance (EII) was recorded as the insertion force was applied
on the MAE. The insertion process of the MAE was also simulated by the finite element method.
Results showed that MAE could insert into skin with a relatively low compression force and maintain
stable contact impedance between the MAE and skin. Bio-signals, including electromyography
(EMG), electrocardiography (ECG), and electroencephalograph (EEG) were also collected. Test results
showed that the MAE could record EMG, ECG, and EEG signals with good fidelity in shape and
amplitude in comparison with the commercial Ag/AgCl electrodes, which proves that MAE is
an alternative electrode for bio-signals monitoring.
Keywords: micro-needle array; electrode; impedance; EMG; ECG; EEG; finite element method

1. Introduction
Bioelectricity is a typical physiological phenomenon of humans which can provide important
information for diagnostics and treatment. However, bioelectric signals are weak and difficult to
collect. Electrodes, including wet electrodes (typical Ag/AgCl wet electrode) and dry electrodes, can
collect and record bioelectric signals [1]. The micro-needle array electrode, as a dry electrode, has
attracted more and more attention for physiological electrical signals monitoring (including EII, ECG,
EEG, and EMG recording) in recent decades [2]. In the EII test, the MAE presents less variation of
contact impedance and better stability due to the significant improvement of the contact interface
between the electrode and skin, compared with conventional Ag/AgCl electrodes and metal planar
bio-electrodes [3,4]. In an EMG signals test, both the MAE and Ag/AgCl electrode can trace the change
of EMG signals well and easily reduce the crosstalk [2,5]. In static state recording of ECG signals,
signals collected by the MAE agree well with that recorded by typical Ag/AgCl electrodes [2,59],
while in a dynamic state recording of ECG signals, the MAE can capture more obvious ECG principal
features due to the reduction of motion artifacts and a stable contact interface between the MAE and
human skin [2,7]. In EEG signals measurement, the MAE can pass through the hairs, reach the scalp,
and penetrate through the dead skin layer without any obstruction. Sensing performance of the MAE
is better in terms of electrode-skin impedance over a long period of recording, as well as a much higher
efficiency in preparation of EEG measurements compared with typical Ag/AgCl electrodes [2,10,11].
Furthermore, Ag/AgCl electrodes work well in short term monitoring but, subsequently, the gel
dries, causing disruption in the signals [8]. The electrode gel may also cause itching, allergic reactions,
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and other skin problems in some patients [2,12]. The MAE can be used without gel and can directly
pierce through the stratum corneum, lower the impedance between the skin and electrode, reduce
motion artifacts, and is convenient for long-term monitoring of bioelectric signals [8,10]. The MAE is
a promising alternative to wet electrodes in some specific situations.
Various fabrication methods of the MAE are employed to fabricate MA from silicon, metal, or
polymer. Photolithography technology with wet etch or dry etch is always used to fabricate MA
on a silicon substrate [5,10,1315]. This method is fit for mass production of MA. However, it has
disadvantages: firstly, photolithography or etching needs sophisticated equipment located in a clean
room and may produce toxic waste. It is inconvenient, expensive, and eco-unfriendly. Secondly, silicon
micro-needles may easily break off and stay in the skin due to its fragile property [5,15]. Thus, metal is
adopted to fabricate MA due to its good strength. Nanosecond IR pulsed-laser machining was used
to fabricate MA on a pure copper substrate for bio-signals monitoring [3]. Nanosecond pulsed-laser
machining has high machining efficiency and flexibility. However, the surface of the micro-needles
is usually rough due to the recast layer and debris deposition on it, and the tips are relatively blunt.
The biocompatibility of pure copper also needs to be further discussed. Polymer is proposed to fabricate
MA due to its good toughness and high yield for the skin insertion of MA. Vacuum-casting technology
was employed to fabricate multiple micro-spike electrodes for EEG recording [11]. The master pattern
was made by CNC micromachining. This technology can also be applied in mass production while
its process is relatively complex. 3D printing technology was also proposed to fabricate 3D MA
using biocompatible acrylic-based resin for EEG and ECG recording [6]. This technique allowed for
personalized customization and flexibility. However, the resolution of 3D printing was low, the size of
MA was in the millimeter scale and the tip diameter was about 100 m. As the MA was fabricated,
a conductive film, such as Ti, Au, Ag, or AgCl, should be subsequently coated on MA by sputtering
electroless plating, electrolysis, e-beam evaporation, etc. [5,10,13,16,17].
In this paper, we introduce a thermal drawing method to fabricate 3D MA from 2D planar
thermosetting polymer film. A simple thermal drawing setup was designed and fabricated.
The polymer is heated to a glassy state, drawn into 3D MA by pillar arrays, and finally solidified by
thermal curing. Thermal drawing technology is very simple, efficient, and low cost. The technology
is also fit for various polymers and mass fabrication. Subsequently, MA is coated with a conductive
film of Ti/Au by magnetron sputtering to fabricate the MAE. The biocompatibility of the MAE will
be discussed. EII of the MAE and Ag/AgCl electrodes will be measured under compression force.
Finite element methods will be proposed to simulate the insertion and pull process of the MAE.
The performance of monitoring ECG, EMG, and EEG bio-signals will be evaluated in comparison with
commercial Ag/AgCl electrodes.
2. Experimental
2.1. MAE Fabrication
2.1.1. Experimental Setup
A simple and effective experimental setup was designed and fabricated for thermal drawing
of MA, as shown in Figure 1. It consists of a temperature adjustment module, z-axis positioner, and
stainless steel pillar array. In the temperature adjustment module, heating rods are employed to heat
copper blocks at a given temperature, and constant temperature water bath pumps low-temperature
water to rapidly cool the bottom copper block. The z-axis positioner could manually slip along the
z direction with the pillar array to draw glassy-state polymer into a 3D MA.

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Figure 1.
1. Thermal
Thermaldrawing
drawing setup
setup for
for MA.
MA.
Figure

2.1.2. Fabrication
Fabrication Process
Process
2.1.2.

Materials
Materials Preparation
Preparation
Thermosetting
Thermosetting polymer,
polymer, 75/25
75/25PLGA
PLGA(Mw
(Mw==200
200kDa)
kDa)was
waspurchased
purchasedfrom
fromShenzhen
Shenzhen Polymtek
Polymtek
Biomaterial
Co.,
Ltd.
(ShenZhen,
China)
PLGA
has
been
widely
used
in
tissue
scaffolds
and
Biomaterial Co., Ltd. (ShenZhen, China) PLGA has been widely used in tissue scaffolds and is
is safe
safe
for
round
PLGA
film
of 0.6
mmmm
thickness
andand
10 mm
diameter
was cut.
for skin
skinpenetration
penetration[18].
[18].A A
round
PLGA
film
of 0.6
thickness
10 mm
diameter
wasThe
cut.
material
of
the
pillar
array
was
316L
stainless
steel,
the
height
was
3
mm,
and
its
diameter
was
The material of the pillar array was 316L stainless steel, the height was 3 mm, and its diameter was
350
66 with
350 m.
m. The
The pillars
pillars were
were welded
welded on
on the
the upper
upper copper
copper block
block in
in an
an array
array of
of 66
with aa separation
separation of
of
11 mm.
mm.
Thermal Drawing of MA
Thermal Drawing of MA
The thermal drawing process of MA is shown in Figure 2ad. Firstly, the round PLGA film was
The thermal drawing process of MA is shown in Figure 2ad. Firstly, the round PLGA film
fixed to the bottom copper block and heated at 140 C. The
PLGA film was heated into a glassy state,
was fixed to the bottom copper block and heated at 140 C. The PLGA film was heated into a glassy
as shown in Figure 2a. The upper copper block was heated at 160 C to preheat
the pillar array.
state, as shown in Figure 2a. The upper copper block was heated at 160 C to preheat the pillar
Secondly, the pillar array was moved down towards the glassy-state PLGA film until the pillar array
array. Secondly, the pillar array was moved down towards the glassy-state PLGA film until the pillar
touched the PLGA film, as shown in Figure 2b. Thirdly, the pillar array was moved upward at a
array touched the PLGA film, as shown in Figure 2b. Thirdly, the pillar array was moved upward at
speed of 0.25 mm/s and then necks were formed between the pillar array and PLGA film due to the
a speed of 0.25 mm/s and then necks were formed between the pillar array and PLGA film due to
surface tension and became narrower. Fourthly, the bottom copper block was rapidly cooled to room
the surface tension and became narrower. Fourthly, the bottom copper block was rapidly cooled to
temperature (about 25 C), as
shown in Figure 2c. Finally, the pillar arrays were move upward
room temperature (about 25 C), as shown in Figure 2c. Finally, the pillar arrays were move upward
continuously and the necks were broken due to the high temperature of the pillar array. MA tips
continuously and the necks were broken due to the high temperature of the pillar array. MA tips were
were
formed,
in Figure 2d.
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formed,
as shown
in Figure 2d.
MA Coating
10 nm Ti film and 100 nm Au film were uniformly coated on the whole MA surface in sequence
by a magnetron sputtering machine (MSP-3300, Beijing Jinshengweina Technology Co., Ltd, Beijing,
China) as shown in Figure 2e. The coating Ti film was used to increase the bonding strength between
the PLGA and Au film [6]. The coating Au film could insure the conductivity of the MAE [6,14]. The
coated micro-needle array was observed by scanning electron microscopy (SEM, JSM-6380LA, JEOL,
Tokyo, Japan).
MAE Assembling
An electrode button was glued to the backside of the MA by conductive silver glue and a medical
Figure
2.2.Fabrication
MAE.
thermal
drawing
process
of MA,
MA,as
(e)Sputtering
Sputtering
coating
adhesive
dressing
was process
bonded
standard-shape
snapprocess
connector,
shown
incoating
Figure 2f.
Figure
Fabrication
processof
ofwith
MAE.a(a)(d):
(a)(d):
thermal drawing
of
(e)
Ti/Au
on
the
of
MAE.
The medical
adhesive
dressing
could
insure MAE
sticks on, and penetrates into, the skin. The standard
Ti/Aufilm
film
onthe
the MA,
MA, and
and (f)
(f)
the assembly
assembly
of MAE.
snap connector could guarantee the connection between the MAE and common bio-signals
2.2. Insertion,
EII Test, and Numerical Simulation
recording
devices.
2.2.1. EII Test during the Insertion Process
The MAE can penetrate through the stratum corneum layer and eliminate the impendence of
the dead skin to collect EII. We designed a setup to test the EII of the MAE during the insertion
process, as shown in Figure 3. The left inner forearm was chosen as the measurement object due to

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MA Coating
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10 nm Ti film and 100 nm Au film were uniformly coated on the whole MA surface in sequence
by a magnetron sputtering machine (MSP-3300, Beijing Jinshengweina Technology Co., Ltd, Beijing,
China) as shown in Figure 2e. The coating Ti film was used to increase the bonding strength between
the PLGA and Au film [6]. The coating Au film could insure the conductivity of the MAE [6,14].
The coated micro-needle array was observed by scanning electron microscopy (SEM, JSM-6380LA,
JEOL, Tokyo, Japan).
MAE Assembling
An electrode button was glued to the backside of the MA by conductive silver glue and
a medical adhesive dressing was bonded with a standard-shape snap connector, as shown in
Figure 2f. The medical adhesive dressing could insure MAE sticks on, and penetrates into, the
skin. Figure
The standard
snapprocess
connector
could
guarantee
connection
the
MAE and
common
2. Fabrication
of MAE.
(a)(d):
thermalthe
drawing
processbetween
of MA, (e)
Sputtering
coating
bio-signals
recording
devices.
Ti/Au film
on the MA,
and (f) the assembly of MAE.
2.2.
2.2. Insertion,
Insertion, EII
EII Test,
Test, and
and Numerical
Numerical Simulation
Simulation
2.2.1. EII Test during the Insertion Process
2.2.1. EII Test during the Insertion Process
The MAE can penetrate through the stratum corneum layer and eliminate the impendence of
The MAE can penetrate through the stratum corneum layer and eliminate the impendence of
the dead skin to collect EII. We designed a setup to test the EII of the MAE during the insertion
the dead skin to collect EII. We designed a setup to test the EII of the MAE during the insertion
process, as shown in Figure 3. The left inner forearm was chosen as the measurement object due to
process, as shown in Figure 3. The left inner forearm was chosen as the measurement object due to
having less hair, a thinner stratum corneum, as well as being a convenient and accurate position for
having less hair, a thinner stratum corneum, as well as being a convenient and accurate position for
electrodes [3,19]. A two-electrode measurement method was proposed to record EII [3]. The location of
electrodes [3,19]. A two-electrode measurement method was proposed to record EII [3]. The location
the MAE and Ag/AgCl electrode is shown in Figure 3. The electrodes were connected to the precision
of the MAE and Ag/AgCl electrode is shown in Figure 3. The electrodes were connected to the
impedance analyzer (Agilent E4980A LCR Meter, Palo Alto, CA, USA) with coaxial wires, to avoid
precision impedance analyzer (Agilent E4980A LCR Meter, Palo Alto, CA, USA) with coaxial wires,
noise. A linear motor (E-861, PI, Karlsruhe, Baden-Wrttemberg, German) could load the MAE on
to avoid noise. A linear motor (E-861, PI, Karlsruhe, Baden-Wrttemberg, German) could load the
the forearm and the force sensor (Nano 17 Titanium, ATI Industrial Automation, Detroit, MI, USA)
MAE on the forearm and the force sensor (Nano 17 Titanium, ATI Industrial Automation, Detroit,
captured the insertion force. The EII signal, insertion force, and displacement could be simultaneously
MI, USA) captured the insertion force. The EII signal, insertion force, and displacement could be
recorded by self-developed software during the insertion process.
simultaneously recorded by self-developed software during the insertion process.
In order to better understand the effect of insertion force on the recording of EII, the EII of the
In order to better understand the effect of insertion force on the recording of EII, the EII of the
MAE and insertion force were recorded during the insertion process. The linear motor speed was
MAE and insertion force were recorded during the insertion process. The linear motor speed was
0.5 mm/s, the injection voltage of the LCR meter was set at 1 V, and its frequency was set at 50 Hz.
0.5 mm/s, the injection voltage of the LCR meter was set at 1 V, and its frequency was set at 50 Hz.
We also recorded EII with the frequency from 20 Hz to 10 kHz when the insertion force was held at
We also recorded EII with the frequency from 20 Hz to 10 kHz when the insertion force was held at
a constant value (about 1 N, 2 N, or 3 N). As the measured impedance is beyond 2 M, we set the test
a constant value (about 1 N, 2 N, or 3 N). As the measured impedance is beyond 2 M, we set the
result as 2 M.
test result as 2 M.

Figure 3. Setup for EII recording during the insertion

insertion process.
process.

2.2.2. Numerical Simulation of Insertion and Pull Process

The mechanism of the MAE insertion and pull process to human skin has not yet been
understood clearly. We proposed a nonlinear FEM model to simulate this process by ABAQUS
Explicit as shown in Figure. 4. For simplicity, we simulated it with a 2-D plane-strain model under
quasi-static conditions. The MAE was inserted into the skin at a vertical direction and drawn from
the skin at a speed of 50 m/s. The insertion depth was 150 m.

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2.2.2. Numerical Simulation of Insertion and Pull Process

The mechanism of the MAE insertion and pull process to human skin has not yet been understood
clearly. We proposed a nonlinear FEM model to simulate this process by ABAQUS Explicit as shown
in Figure 4. For simplicity, we simulated it with a 2-D plane-strain model under quasi-static conditions.
The MAE was inserted into the skin at a vertical direction and drawn from the skin at a speed of
50 m/s. The insertion depth was 150 m.
Human skin consists of four layers: stratum corneum, epidermis, dermis, and hypodermis.
We assumed the skin of each layer as the isotropous and incompressible material to simplify the
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908
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simulation.
Neo-Hooken
constitutive model of skin was employed [20,21] and the 5mechanical
properties are listed in Table 1 [2224]. The hypodermis layer was ignored in the model since the MAE
Human skin consists of four layers: stratum corneum, epidermis, dermis, and hypodermis. We
could not
reach the
andskin
its effect
was
minimal.
The material
of skinmaterial
was defined
by thetheVUMAT
assumed
of each
layer
as the isotropous
and model
incompressible
to simplify
subroutine
in ABAQUS.
The failure
criterionmodel
handled
by was
the distortion
energy
theory
was introduced
simulation.
The Neo-Hooken
constitutive
of skin
employed [20,21]
and
the mechanical
properties
are listed
in Table
1 [2224].
The hypodermis
layer
was ignored
themicro-needle
model since thetips was
in the skin
material
model.
When
the effective
stress of an
element
nearinthe
could not failure
reach and
its effectitwas
minimal.
The material
of skin was
by the
beyondMAE
the specified
criterion,
would
be identified
andmodel
eliminated
fromdefined
the mesh.
The skin
VUMAT subroutine in ABAQUS. The failure criterion handled by the distortion energy theory was
was defined as a deformable body and meshed with 12,000 CPE4R elements, each micro-needle was
introduced in the skin material model. When the effective stress of an element near the micro-needle
definedtips
as awas
discrete
rigid body and meshed with 469 CPS4R elements, and the base of the MAE was
beyond the specified failure criterion, it would be identified and eliminated from the
definedmesh.
as anThe
analytical
body.
skin wasrigid
defined
as a deformable body and meshed with 12,000 CPE4R elements, each
micro-needle was defined as a discrete rigid body and meshed with 469 CPS4R elements, and the
Table
properties
base of the MAE was defined
as 1.
anMechanical
analytical rigid
body. of human skin.
Stratum properties
Corneum of human
Epidermis
Table 1. Mechanical
skin.
C10 (MPa)
Failure stress (MPa)
C10 (MPa)
Density (kg/m3 )
Failure stress (MPa)
Thickness (mm)
Density (kg/m3)
Thickness (mm)

10Corneum
Stratum
25
10
1300
25
0.07
1300
0.07

0.11
Epidermis

0.11
1200
-0.05
1200
0.05

Dermis

Dermis0.16
7.3
0.16
1200
7.3
0.1
1200
0.1

Surface-to-surface contact was defined between micro-needles and skin using the kinematic
Surface-to-surface
contact was
defined
micro-needles
andwith
skin using
the kinematic
contact algorithm.
Contact between
the
MAEbetween
and skin
was modeled
the friction
coefficient of
contact algorithm. Contact between the MAE and skin was modeled with the friction coefficient of
0.42 [25]. The rotation of the X, and X and Y translation were constrained in the nodes of the MAE.
0.42 [25]. The rotation of the X, and X and Y translation were constrained in the nodes of the MAE.
The displacement
boundary
conditions
included
nodes
along
the bottom,
left,
and right
The displacement
boundary
conditionson
onthe
the skin
skin included
nodes
along
the bottom,
left, and
right
edges that
were
pinned,
whereas
the
top
edge
was
traction-free.
The
explicit
method
was
introduced
edges that were pinned, whereas the top edge was traction-free. The explicit method was introduced
to calculate
the process.
to calculate
the process.

Figure 4. Finite element model of the MAE insertion and pull process.
Figure
4. Finite element model of the MAE insertion and pull process.

2.3. Bio-Signals Recording

2.3. Bio-Signals Recording

In order to better understand the sensing performance of MAE, bio-signals, including EMG,

In order
to better
understand
thethesensing
of conventional
MAE, bio-signals,
ECG, and
EEG, were
recorded by
MAE inperformance
comparison with
Ag/AgClincluding
electrodes EMG,
(JK- ECG,
1(A~H)
Shanghai
Junkang
Supplies LTD.,
CO, Shanghai, China).
Measurements
and EEG,
weretype,
recorded
by the
MAEMedical
in comparison
with conventional
Ag/AgCl
electrodeswere
(JK-1(A~H)
firstly performed
with
the MAE
and thenLTD.,
repeated
Ag/AgClChina).
electrodes
under the samewere
test firstly
type, Shanghai
Junkang
Medical
Supplies
CO,with
Shanghai,
Measurements
conditions. The electrodes were located at the same position and followed the same procedures in
performed with the MAE and then repeated with Ag/AgCl electrodes under the same test conditions.
both cases. The experiments were operated on three healthy volunteers from 23 to 26 years old at
The electrodes
were located
at the at
same
room temperature
and repeated
least position
five times. and followed the same procedures in both cases.
The experiments were operated on three healthy volunteers from 23 to 26 years old at room temperature
2.3.1. EMG
Test five times.
and repeated
at least
The biceps brachii muscle of the right arm was employed as the EMG measuring object, as
shown in Figure 5. The differential method was introduced to record EMG signals. The upper arm
was placed on the plate and the right hand held the stick. The stick was assembled on one end of

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2.3.1. EMG Test

The biceps brachii muscle of the right arm was employed as the EMG measuring object, as shown
in Figure 5. The differential method was introduced to record EMG signals. The upper arm was placed
on the plate
right hand held the stick. The stick was assembled on one end of plate.
Sensorsand
2016, the
16, 908
6 ofThe
13 angle
between upper arm and forearm was 90 . If the upper arm tried to rotate the plate, the torque sensor
plate. The angle between upper arm and forearm was 90. If the upper arm tried to rotate the plate,
(AKC-205, 701st Research Institute of China Aerospace Science and Technology Corporation, Beijing,
the torque sensor (AKC-205, 701st Research Institute of China Aerospace Science and Technology
China) are
the otherBeijing,
end ofChina)
the plate
would
value.
Twothe
recording
electrodes
Corporation,
are the
otherrecord
end of the
the torque
plate would
record
torque value.
Two were
stuck onrecording
the biceps
brachii
with
a
distance
of
2
cm
and
a
ground
electrode
was
placed
on
the elbow.
electrodes were stuck on the biceps brachii with a distance of 2 cm and a ground electrode
These electrodes
were
connected
to
a
tele-EMG
system
(MyoSystem2400T,
Noraxon,
Scottsdale,
AZ,
was placed on the elbow. These electrodes were connected to a tele-EMG system (MyoSystem2400T,
Noraxon,
Scottsdale,
AZ,
USA).
EMG
signals
were
collected
by
data
acquisition
card
(DAQ-6341,
USA). EMG signals were collected by data acquisition card (DAQ-6341, National Instruments, Austin,
National
Instruments,
TX, USA)
and analyzed
by (LabVIEW
a customized
LabVIEW
program
TX, USA)
and analyzed
by aAustin,
customized
LabVIEW
program
2012,
National
Instruments
(LabVIEW 2012, National Instruments Corporation, Austin, TX, USA). The skin was firstly cleaned
Corporation, Austin, TX, USA). The skin was firstly cleaned with medical alcohol. The volunteer held
with medical alcohol. The volunteer held the stick and increased the torque from 0 Nm to 15 Nm. As
the sticktheand
increased
torque
0 Nm toheld
15 for
Nm.
As5the
torque
torque
reached the
about
15 Nm,from
the volunteer
about
s. Then,
the reached
volunteer about
released15
theNm, the
volunteer
held
for
about
5
s.
Then,
the
volunteer
released
the
force.
The
torque
and
EMG
signals
force. The torque and EMG signals were recorded simultaneously. The process was be repeated were
several
times.
recorded
simultaneously.
The process was be repeated several times.

Figure
5. Schematicdiagram
diagram of
measurement.
Figure
5. Schematic
ofEMG
EMG
measurement.

2.3.2. ECG Test

2.3.2. ECG Test

The MAE sensing performance of ECG signals was operated in static and dynamic state by

Thestandard
MAE sensing
performance
ofwere
ECGconnected
signals was
in staticfrom
andMultipurpose
dynamic state by
II-lead method.
Electrodes
to an operated
ECG100C module
Polygraph
BIOPAC,
Goleta,were
CA, USA).
Measuring
electrodes
were module
stuck on the
rightMultipurpose
wrists
standard
II-lead (MP150,
method.
Electrodes
connected
to an
ECG100C
from
and (MP150,
left ankle, BIOPAC,
and grounded
electrode
on the
right ankle.electrodes
The volunteer
laystuck
in a bed
the wrists
Polygraph
Goleta,
CA,was
USA).
Measuring
were
onduring
the right
static state test and walked on a treadmill at a uniform velocity of 3 km/h during the dynamic state
and left ankle, and grounded electrode was on the right ankle. The volunteer lay in a bed during the
test. The test lasted about half an hour.
static state test and walked on a treadmill at a uniform velocity of 3 km/h during the dynamic state
test. The2.3.3.
testEEG
lasted
Testabout half an hour.
EEG measures voltage fluctuations resulting from ionic current within the neurons of the brain.
2.3.3. EEG Test

A unipolar connection method was used in the EEG test. Three electrodes were connected to the

EEG100C
module
of Multipurpose
Polygraph,
twofrom
measuring
electrodeswithin
and one
ground
electrode.
EEG
measures
voltage
fluctuations
resulting
ionic current
the
neurons
of the brain.
One
measuring
electrode
was
placed
on
the
standard
position
(Fp1)
of
the
1020
system.
The
ground
A unipolar connection method was used in the EEG test. Three electrodes were connected to the
electrode and the other measuring electrode were located on the left earlobe. The volunteers were
EEG100C module of Multipurpose Polygraph, two measuring electrodes and one ground electrode.
asked to blink for 30 s and rest for 30 s during the blinking test. Volunteers then were required to
One measuring
electrode
was placed
on the
standard
position
the
1020
system.
The
alternate closed
and opened
eyes with
an interval
of two
seconds(Fp1)
underof
the
testers
guide
during
the ground
electrode
and
theand
other
measuring
electrode
were
onabout
the left
earlobe. The volunteers were
eyes
closed
open
transition test.
The whole
test located
process last
5 min.
asked to blink for 30 s and rest for 30 s during the blinking test. Volunteers then were required to
alternate closed and opened eyes with an interval of two seconds under the testers guide during the
eyes closed and open transition test. The whole test process last about 5 min.

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3. Results and Discussion

3. Results and Discussion
3.1. Characterization of the MAE
3.1. Characterization of the MAE
The MAE fabricated by thermal drawing and coated with Ti/Au film is shown in Figure 6a. The
MAE
fabricated
by thermal
drawing
and PLGA,
coatedTi,
with
is shown in Figure
6a.
MAEThe
mainly
consists
of PLGA
MA and its
Ti/Au film.
andTi/Au
Au arefilm
all biocompatible
which can
The
MAE
mainly
consists
of
PLGA
MA
and
its
Ti/Au
film.
PLGA,
Ti,
and
Au
are
all
biocompatible
guarantee the compatibility of the MAE in human skin [18,2629]. The MA consists of 6 6 micro-needles
which
guarantee
the compatibility
the with
MAEthat
in human
skin [18,2629].
Thearray.
MA consists
of
with ancan
interval
of 1 mm,
which matchesofwell
of the stainless
steel pillar
The height
6ofMA
6 micro-needles
with an interval
of in
1 mm,
which
matches
wellheight
with that
of the
steel
distributes uniformly
as shown
Figure
6b. The
average
is 500
10 stainless
m, which
is
pillar
array.
The
height
of
MA
distributes
uniformly
as
shown
in
Figure
6b.
The
average
height
is
appropriate for painless recording [10]. The MA surface was very smooth, which may decrease the
500
10friction
m, which
appropriate
recording
[10]. The MA
surface
was veryofsmooth,
which
sliding
forceisbetween
skinfor
andpainless
MA during
the penetration.
One
micro-needle
MA is shown
may
decrease
the
sliding
friction
force
between
skin
and
MA
during
the
penetration.
One
micro-needle
in Figure 6c. The shape of the micro-needle looks like a cone. The base diameter of micro-needles was
of
MA500
is shown
in and
Figure
Theof
shape
of the micro-needle
cone.
The
base diameter
of
about
10 m
its 6c.
radius
tip curvature
was about looks
40 2 like
m.aThe
base
diameter
was kept
micro-needles
was about
500 10 mand
andavoid
its radius
of tip
curvature
wasinsertion.
about 40 2 m. The base
large to strengthen
the micro-needle
buckling
during
the skin
diameter was kept large to strengthen the micro-needle and avoid buckling during the skin insertion.

Figure 6. (a) Photo of the MAE; (b) SEM image of MA; and (c) SEM image of the micro-needles.
Figure 6. (a) Photo of the MAE; (b) SEM image of MA; and (c) SEM image of the micro-needles.

3.2. EII Test and Insertion Process

3.2. EII Test and Insertion Process
3.2.1. EII Recording during MAE Compression
3.2.1. EII Recording during MAE Compression
The EII of MAE during the insertion process at 50 Hz is shown in Figure 7a. The EII value is
The EII
ofatMAE
during the
insertion
process at
50 Hz
is shown
in Figure
EII between
value is
extremely
high
the beginning
and
the compression
force
is null
due to the
absence7a.
of The
contact
extremely
high
at Subsequently,
the beginningmicro-needle
and the compression
force
is null
to the
absence
contact
the
MAE and
skin.
tips come in
contact
withdue
forearm
skin
and theofinsertion
between
the
MAE
and
skin.
Subsequently,
micro-needle
tips
come
in
contact
with
forearm
skin
and
force gradually increases, and EII maintains its high impedance value due to the high impedance
the
insertion
force
gradually
increases,
and
EII
maintains
its
high
impedance
value
due
to
the
high
of the stratum corneum layer. As the compression force is about 75 mN, EII suddenly changes the
impedance
of be
thedue
stratum
layer.
As the
compression
force is
about
75 mN,
EII suddenly
slope.
It may
to thecorneum
penetration
of one
micro-needle
through
the
stratum
corneum
and the
changes
the
slope.
It
may
be
due
to
the
penetration
of
one
micro-needle
through
the
stratum
corneum
contact impedance between the MAE and skin decreases rapidly. As the MAE is moved forward, the
and the contact
betweeninto
the the
MAE
and
decreases
As the
MAE
moved
micro-needles
of impedance
the MAE penetrates
skin
oneskin
by one
and therapidly.
EII decreases
with
theisinsertion
forward,
the
micro-needles
of
the
MAE
penetrates
into
the
skin
one
by
one
and
the
EII
decreases
depth. When a force larger than 0.55 N is applied on the MAE, the MAE achieves lower EII thanwith
the
the insertion
depth. When
a force
larger
0.55 N is force
applied
MAE,
the MAE
lower
Ag/AgCl
electrodes
(120 K).
When
thethan
compression
on on
thethe
MAE
is larger
thanachieves
1 N, EII of
the
EII than
the Ag/AgCl
K). When
the85compression
force on
the of
MAE
is larger
than 1
MAE
reaches
a steadyelectrodes
state, and(120
its value
is about
K. The average
force
an adult
applying
N, EII
of with
the MAE
steady20
state,
andTherefore,
its value iswe
about
K.press
The average
force
an adult
the
MAE
their reaches
thumb isa about
N [30].
can 85
easily
the MAE
intoofskin
with
applying
the
MAE
with
their
thumb
is
about
20
N
[30].
Therefore,
we
can
easily
press
the
MAE
into
skin
a thumb and stably record the bio-signals.
with The
a thumb
stably record
the bio-signals.
MAEand
impedances
of skin-electrode
under different compression forces at the driving current
The
MAE
impedances
of
skin-electrode
under
different
compression
forces
at thewith
driving
frequency from 20 Hz to 10 kHz are shown in
Figure
7b. The
EII of MAE
decreases
the
current
frequency
from
20
Hz
to
10
kHz
are
shown
in
Figure
7b.
The
EII
of
MAE
decreases
with
the
frequency. The impendence of the human body always consist of resistance and capacitive resistance.
frequency.
The impendence
of the human
always consist
of resistance
and capacitive
resistance.
The
capacitive
resistance decreases
with body
the frequency
of inject
driving current.
The EII
slightly
The
capacitive
resistance
decreases
with
the
frequency
of
inject
driving
current.
The
EII
slightly
decreases with the insertion force at a given driving current frequency, as shown in Figure
7b.
decreases
withEII
the
insertion
forceofat
a given
driving current
frequency,
as and
shown
in impedance.
Figure 7b.
The
measured
usually
consists
contact
impedance,
electrode
impedance,
tissue
The measured
EII usually
consiststhe
of contact
impedance,
impedance,
andthe
tissue
impedance.
The
contact impedance
between
electrode
and skin electrode
slightly decreased
with
insertion
force
The
contact
impedance
between
the
electrode
and
skin
slightly
decreased
with
the
insertion
force
since both the electrode impedance and tissue impedance maintain a constant value at a given current
since both the
electrode
tissue
impedance
maintain
a constant
at a given
frequency.
Therefore,
theimpedance
MAE can and
record
EII or
bio-signals
at a relatively
lowvalue
insertion
force.current
As the
frequency.
Therefore,
the
MAE
can
record
EII
or
bio-signals
at
a
relatively
low
insertion
force.
As the
the
compression force on the MAE is beyond about 5 N, the subjects would feel tingling during
compression force on the MAE is beyond about 5 N, the subjects would feel tingling during the

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of 13

insertion
process.
Since
the MAE
can stably
record EII
aa compression
force of
11 N,
insertionprocess.
process.Since
Since
MAE
stably
EII under
compression
N, the
the
insertion
thethe
MAE
can can
stably
recordrecord
EII under
aunder
compression
force of 1force
N, theofbio-signals
bio-signals
recording
on
the
subjects
is
almost
painless.
The
skin
deformation
under
the
insertion
bio-signals
recording
on
the
subjects
is
almost
painless.
The
skin
deformation
under
the
insertion
recording on the subjects is almost painless. The skin deformation under the insertion force of 6 N
force
of
shown
in Figure
7c.
The
mark
on
forearm
skin by
the
will
disappear
force
of 66 N
N is
is
shown
Figure
7c.on
The
mark
on the
the
forearm
bywill
the MAE
MAE
will gradually
gradually
is
shown
in
Figure
7c.inThe
mark
the
forearm
skin
by theskin
MAE
gradually
disappeardisappear
in about
in
about
8
min
and
the
harm
on
skin
is
minimal.
about
minharm
and the
harmison
skin is minimal.
8inmin
and8 the
on skin
minimal.

(a)
EII
during
the
insertion
process,
Figure
Figure 7.
7. Insertion
Insertion force
force and
and EII
EII test.
test. (a)
(a) EII
EII during
during the
the insertion
insertion process,
process, (b)
(b) EII
EII under
under different
different input
input
frequency,
and
(c)
skin
deformation
under
the
impression
force
of
6N.
current
frequency,
and
(c)
skin
deformation
under
the
impression
force
of
6N.
current frequency, and (c) skin deformation under the impression force of 6N.

3.2.2.
3.2.2. Numerical
Numerical Simulation
Simulation of
of the
the Insertion
Insertion and
and Pull
Pull Process
Process
Figure
of
the
insertion
process.
As
tips
8ac
presentthe
theskin
skinstress
stressdistribution
distribution
the
insertion
process.
As
the
micro-needle
Figure 8ac
8ac present
present
the
skin
stress
distribution
ofof
the
insertion
process.
As the
the micro-needle
micro-needle
tips
touch
the
layer
of
the
stress
concentration
occurs
at
the
tips
touch
the
layer
of skin,
stress
concentration
occurs
thetip
tiparea
areaof
ofMAE
MAE as
as shown
shown
touch
the top
top top
layer
of skin,
skin,
thethe
stress
concentration
occurs
atat
the
tip
area
of
MAE
as
shown in
in
Figure
8a.
Top
layer
skin
initially
deforms
concave
downward
under
the
advancing
tips
until
8a.
Top
layer
skin
initially
deforms
concave
downward
under
the
advancing
tips
until
a
critical
Figure 8a. Top layer skin initially deforms concave downward under the advancing tips until aa
critical
stress
to
effective
stress
of
elements
the
stress
to leads
the skin
penetration.
Once the Once
effective
of skin
elements
near
the tipsnear
exceeds
the
criticalleads
stress
leads
to the
the skin
skin penetration.
penetration.
Once the
thestress
effective
stress
of skin
skin
elements
near
the tips
tips
exceeds
specified
failure
criterion,
the
nodes
separated
due
specified
failure
criterion,
the
nodes are
to the deletion
ofdeletion
dead of
elements.
Thus,
the
exceeds the
the
specified
failure
criterion,
theseparated
nodes are
aredue
separated
due to
to the
the
deletion
of dead
dead elements.
elements.
Thus,
tear
skin.
The
skin
is
on
micro-needle
tips tear tips
the
skin.
The skin
stress
is always on the
micro-needle
Thus, the
the micro-needle
micro-needle
tipshuman
tear the
the human
human
skin.
Theconcentration
skin stress
stress concentration
concentration
is always
always
on the
the
micro-needle
tips
during
the
insertion
process,
which
verifies
that
the
skin
tissue
is
cut
away
by
tips
during thetips
insertion
whichprocess,
verifieswhich
that the
skin tissue
is cut
byisthe
as
micro-needle
duringprocess,
the insertion
verifies
that the
skinaway
tissue
cutMAE
awaytips,
by the
the
MAE
tips,
as
shown
in
Figure
8ac.
The
stress
concentration
at
the
micro-needle
surface
may
lead
shown
in
Figure
8ac.
The
stress
concentration
at
the
micro-needle
surface
may
lead
to
the
increase
MAE tips, as shown in Figure 8ac. The stress concentration at the micro-needle surface may lead to
to
the
increase
of
the
force
between
friction
force
the
of
friction
between
micro-needles
and skin. and
The
friction
increases
with thewith
contact
thethe
increase
of force
the friction
friction
force
between micro-needles
micro-needles
and skin.
skin. The
Theforce
friction
force increases
increases
with
the
contact
area
micro-needles
and
as
MAE
skin
more
fits
well
area
between
micro-needles
and skin
asskin
the MAE
in the in
skin
It fits It
well
contact
area between
between
micro-needles
and
skin
as the
theinserts
MAE inserts
inserts
in the
themore
skin deeply.
more deeply.
deeply.
It
fitswith
well
with
the
plot
of
insertion
force
vs.
displacement
is
shown
in
Figure
7a.
The
stress
interaction
the
plot
of
insertion
force
vs.
displacement
is
shown
in
Figure
7a.
The
stress
interaction
of
adjacent
with the plot of insertion force vs. displacement is shown in Figure 7a. The stress interaction of
of
adjacent
can
ignored
during
the
process
Figure
8ac,
so
micro-needles
can be ignored
insertion
process as
shownas
inshown
Figurein
8ac,
so the
distance
adjacent micro-needles
micro-needles
can be
beduring
ignoredthe
during
the insertion
insertion
process
as
shown
in
Figure
8ac,
so the
the
distance
of
micro-needles
(1
mm)
for
MAE
8ce
the
of
adjacent
micro-needles
(1 mm) is
for MAE
penetration.
Figure Figure
8ce present
the stress
distance
of adjacent
adjacent
micro-needles
(1suitable
mm) is
is suitable
suitable
for
MAE penetration.
penetration.
Figure
8ce present
present
the
stress
distribution
of
the
pull
process.
As
the
MAE
is
drawn
back,
the
compression
state
of
the
skin
distribution
of
the
pull
process.
As
the
MAE
is
drawn
back,
the
compression
state
of
the
skin
near
the
stress distribution of the pull process. As the MAE is drawn back, the compression state of the skin
near
into
aa tensile
The
profile
of
deforms
from
to
micro-needles
turns intoturns
a tensile
Thestate.
profile
of skin
deforms
from
concave
to concave
convex, and
finally
near the
the micro-needles
micro-needles
turns
intostate.
tensile
state.
The
profile
of skin
skin
deforms
from
concave
to convex,
convex,
and
finally
becomes
flat.
The
taper
holes
gradually
shrink
due
to
the
elasticity
of
skin
during
the
becomes
flat.
The
taper
holes
gradually
shrink
due
to
the
elasticity
of
skin
during
the
pull
process.
and finally becomes flat. The taper holes gradually shrink due to the elasticity of skin during the pull
pull
process.
The
fits
the
The
shape
of shape
insertion
holes fitsholes
with the
skin
in Figurein
7c.Figure
process.
The
shape of
of insertion
insertion
holes
fits with
withdeformation
the skin
skin deformation
deformation
in
Figure 7c.
7c.

Figure
and
pull
process.
Figure 8.
8. Stress
Stress distribution
distribution on
on human
human skin
skin during
during the
the insertion
insertion and
and pull
pull process.
process.
Figure
8.
Stress
distribution
on
human
skin
during
the
insertion

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3.3. Bio-Signals Measurement

3.3. Bio-Signals Measurement
3.3.1. EMG Measurement
3.3.1. EMG Measurement
EMG signal has a variety of biomedical applications, such as a diagnostics tool for identifying
EMG signal
has a avariety
of tool
biomedical
applications,
such aascontrol
a diagnostics
toolprosthetic
for identifying
neuromuscular
diseases,
research
for studying
kinesiology,
signal for
devices,
a research
tool for
studying
kinesiology,
a control
for prosthetic
andneuromuscular
so on. Surface diseases,
EMG signals
of the biceps
brachii
muscle
recorded by
the MAEsignal
is shown
in Figure 9a
devices,
on. Surface
signals
the biceps
byelectrical
the MAE potential
is shown of
as the
rightand
armsoapplied
forceEMG
to rotate
the of
stick.
As the brachii
torque muscle
is aboutrecorded
0 Nm, the
in
Figure
9a
as
the
right
arm
applied
force
to
rotate
the
stick.
As
the
torque
is
about
0
Nm,
the
electrical
biceps brachii muscle cells is in a low amplitude. When the torque increases from 0 Nm to 15 Nm, the
potential
biceps
brachii or
muscle
cells is in aactivated,
low amplitude.
When
the torque
increases
from 0rapidly
Nm
muscle
cellsofare
electrically
neurologically
and the
electrical
potential
increases
to
15
Nm,
the
muscle
cells
are
electrically
or
neurologically
activated,
and
the
electrical
potential
to a high amplitude. The biceps brachii muscle is contracted from the relaxation state. When the
increases rapidly to a high amplitude. The biceps brachii muscle is contracted from the relaxation
volunteer holds the stick with the torque of 15 Nm for 5 s, the EMG signal maintains a high value
state. When the volunteer holds the stick with the torque of 15 Nm for 5 s, the EMG signal maintains
due to the sustained contraction of the muscle. The biceps brachii muscle is released and the EMG
a high value due to the sustained contraction of the muscle. The biceps brachii muscle is released and
signal is at a low amplitude again as the rotation force is unloaded. The EMG recording process
the EMG signal is at a low amplitude again as the rotation force is unloaded. The EMG recording
by the MAE suggests that the MAE can trace the change of EMG signals. The EMG signal of the
process by the MAE suggests that the MAE can trace the change of EMG signals. The EMG signal of
biceps
brachii muscle recorded by the conventional Ag/AgCl electrode also shows a similar profile in
the biceps brachii muscle recorded by the conventional Ag/AgCl electrode also shows a similar
comparison
with the MAE
presented
Figure 9.inItFigure
demonstrates
that the MAE
canMAE
clearly
and
profile in comparison
with
the MAE in
presented
9. It demonstrates
that the
cansense
clearly
record
surface
signalEMG
with signal
good fidelity.
The
contact
surface
ofsurface
the conventional
Ag/AgCl
sensethe
and
recordEMG
the surface
with good
fidelity.
The
contact
of the conventional
2 and the MAE is only about 78.5 mm2 . The MAE is more suitable for use
electrode
is
about
200
mm
2
2
Ag/AgCl electrode is about 200 mm and the MAE is only about 78.5 mm . The MAE is more suitable
on for
theuse
small
muscles.
Furthermore,
micro-needles
distribution,
number,
andand
sizesize
of the
MAE
can
on the
small muscles.
Furthermore,
micro-needles
distribution,
number,
of the
MAE
be can
designed
and customized
by thermal
drawing
method
according
to thetoshape
and size
muscle
be designed
and customized
by thermal
drawing
method
according
the shape
andofsize
of
monitored.
Thus, the Thus,
MAE may
be more
for both improvement
of EMG signal
selectivity
muscle monitored.
the MAE
mayconvenient
be more convenient
for both improvement
of EMG
signal
and
elimination
the crosstalk.
Thiscrosstalk.
is a critical
phenomenon
the case of several
muscles
present
selectivity
andofelimination
of the
This
is a critical in
phenomenon
in the case
of several
present
in a small
space or when
volunteers
have small
anthropometric
dimensions.
in amuscles
small space
or when
the volunteers
havethe
small
anthropometric
dimensions.
Therefore,
the MAE
Therefore,
MAEin
is EMG
also a recording
good choice
EMG recording
forapplications
potential medical
due to
is also
a goodthe
choice
forinpotential
medical
due toapplications
its good sensitivity
its
good
sensitivity
and
fidelity.
and fidelity.

Figure
9. 9.
EMG
(b) Ag/AgCl
Ag/AgClelectrodes.
electrodes.
Figure
EMGsignals
signalsrecorded
recordedby:
by: (a)
(a) MAE;
MAE; and (b)

3.3.2.
ECG
Measurement
3.3.2.
ECG
Measurement
ECG
signal
is always
used
test
frequency
rate
heartbeats,the
thesize
sizeand
andposition
positionofofthe
AnAn
ECG
signal
is always
used
to to
test
thethe
frequency
rate
ofof
heartbeats,
the
heart
chambers,
the
presence
of
any
damage
to
the
heart's
muscle
cells,
the
effects
of cardiac
heart chambers, the presence of any damage to the heart's muscle cells, the effects of cardiac
drugs,
drugs,
and
the
function
of
implanted
pacemakers
[31].
Figure
10a
presents
4-s
ECG
recording
results
and the function of implanted pacemakers [31]. Figure 10a presents 4-s ECG recording results
using
using the MAE and Ag/AgCl electrodes from the static state test. The recording performance of the
the MAE and Ag/AgCl electrodes from the static state test. The recording performance of the MAE
MAE is comparable with Ag/AgCl electrodes. The features of the ECG signal, such as the QRS
is comparable with Ag/AgCl electrodes. The features of the ECG signal, such as the QRS complex,
complex, T and P waves, are all distinguishable as reported in [2,7,32]. The heart rate in this subject
T and P waves, are all distinguishable as reported in [2,7,32]. The heart rate in this subject is about
is about 65 beats per minute. Therefore, the MAE can record the characteristic ECG peaks effectively
65 beats per minute. Therefore, the MAE can record the characteristic ECG peaks effectively in the
in the static state. Figure 10b presents 3-s ECG recording results using the MAE and Ag/AgCl electrodes
static
state. Figure 10b presents 3-s ECG recording results using the MAE and Ag/AgCl electrodes
from the dynamic state test. The ECG signals are seriously affected by motion artifacts [7,33]. As the
from
the dynamic
state
test.
The ECG
signals
are treadmill,
seriously the
affected
by motion
artifacts
As the
subject
swung the
arms
during
walking
on the
skin shifted
in respect
of [7,33].
underlying

Sensors 2016, 16, 908

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subject swung the arms during walking on the treadmill, the skin shifted in respect of underlying
Sensors 2016, 16, 908
10 of 13
tissues, modifying the electrodes relative positions and generating the signal drifts and motion artifacts.
The signals
measured
by both
the Ag/AgCl
and
the MAE
seriously
disturbed
tissues,
modifying
the electrodes
relativeelectrodes
positions and
generating
theare
signal
drifts and
motion by noise
signals measured
by both thewith
Ag/AgCl
and the MAE
due to theartifacts.
motionThe
artifacts
in comparison
the electrodes
signals recorded
inare
theseriously
static disturbed
state. The typical
by
noise
due
to the motion artifacts in comparison with the signals recorded in the static state.
Sensors
2016,
16, 908
10 The
of 13
R waves and
T waves
of the MAE results are recognizable and the heart frequency rate can
be calculated.
typical R waves and T waves of the MAE results are recognizable and the heart frequency rate can
ECG signal
collected
by
has more
QRS complex,
P drifts
waves
and
T
waves than
tissues,
modifying
theMAE
electrodes
relative
positions
anddistinguishable
generating
theQRS
signal
motion
be
calculated.
ECGthe
signal
collected
by
the distinguishable
MAE
has more
complex,
Pand
waves
and
artifacts.
signals
both
the Ag/AgCl
electrodes
andcollected
the MAE
areAg/AgCl
seriously
disturbed shift from
signal by Ag/AgCl
electrodes.
The by
ECG
signals
collected
by Ag/AgCl
electrodes
seriously
T
waves The
than
signalmeasured
by Ag/AgCl
electrodes.
The ECG
signals
by
electrodes
by noise
the
artifacts
in infer
comparison
signals
the
static
state. The
seriously
shifttofrom
the
We
thatinto
thewith
MAE
can
insert
into
theinskin
maintain
a
the baseline.
We due
infer
thatmotion
thebaseline.
MAE
can
insert
thethe
skin
andrecorded
maintain
a and
relatively
more
stable
typical R waves
and Telectrode-skin
waves of the contact
MAE results
are recognizable and the heart frequency rate can
relatively
more stable
interface.
electrode-skin
contact
interface.
be calculated. ECG signal collected by the MAE has more distinguishable QRS complex, P waves and
T waves than signal by Ag/AgCl electrodes. The ECG signals collected by Ag/AgCl electrodes
seriously shift from the baseline. We infer that the MAE can insert into the skin and maintain a
relatively more stable electrode-skin contact interface.

Figure
10.signals
ECG signals
recorded:
(a)in
in the
the static
andand
(b) in(b)
thein
dynamic
state.
Figure 10.
ECG
recorded:
(a)
staticstate,
state,
the dynamic
state.

EEG signals can be used to diagnose epilepsy, sleep disorders, coma, encephalopathies, brain

EEG death,
signals
beThe
used
epilepsy,
disorders,
coma,
encephalopathies,
brain
andcan
so on.
EEGtois diagnose
more difficult
to capturesleep
since its
amplitude is
in the order
of V while
the
ECG
is
in
the
range
of
mV.
EEG
signals
recorded
on
Fp1
by
MAE
and
Ag/AgCl
electrodes
are
Figure
10.
ECG
signals
recorded:
(a)
in
the
static
state,
and
(b)
in
the
dynamic
state.
death, and so on. The EEG is more difficult to capture since its amplitude is in the order of V while the
shown
in Figure
11. Signal
profiles captured
by on
the Fp1
MAEby
areMAE
very similar
with that ofelectrodes
the Ag/AgClare shown
ECG is in the
range
of mV.
EEG signals
recorded
and Ag/AgCl
EEG signals
be used
to diagnose
epilepsy,
sleep as
disorders,
encephalopathies,
brain
electrodes
during can
the eyes
closed
and eyes open
transition
shown incoma,
Figure
11a. Both beta rhythm
in Figure 11.
Signal
profiles
by
the MAE
are very
similar
withisthat
oforder
the
Ag/AgCl
electrodes
death,
and so
on. Thecaptured
EEG
is more
difficult
to capture
its amplitude
in the
of Vinwhile
(eyes
open
condition)
and alpha
rhythm
(eyes
closed since
condition)
are recognizable,
as found
[10].
during theWhen
eyes
closed
and
open
transition
as
shown
inthe
Figure
Both
rhythm
the
ECG
issubject
in the
range
of mV.
signals
recorded
on Fp1
by blink
MAE11a.
and Ag/AgCl
electrodes
are(eyes open
the
waseyes
asked
to EEG
blink
the eyes
successively,
signal
comesbeta
in
on
the EEG
shown
in Figure
11. Signal
profiles
captured
by the
MAE
veryobserved
similar with
that
of
theMAE
Ag/AgCl
and rhythm
fluctuates
regularly.
The condition)
same
fluctuations
are
byasboth
the
and When the
condition)recording
and alpha
(eyes
closed
arearerecognizable,
found
in
[10].
electrodeselectrodes,
during theaseyes
closed
and eyes
shown
in Figure
rhythm
Ag/AgCl
shown
in Figure
11b.open
Bothtransition
the MAE as
Ag/AgCl
electrodes
can monitor
EEG
subject was
asked to
blink the
eyes
successively,
the
blinkand
signal
comes
in11a.
onBoth
thebeta
EEG
recording
and
(eyes open
and
alpha capture
rhythm bio-signals
(eyes closedwithout
condition)
recognizable,
in [10].
signals,
but condition)
MAE could
directly
skinare
preparation
(suchasasfound
hair cutting
fluctuates and
regularly.
The was
same
fluctuations
both
thesignal
MAE
and
When
the
subject
asked
to blink
theare
eyesobserved
successively,
blink
comes
inAg/AgCl
on the
EEGelectrodes,
skin
abrasion)
and
application
of electrolytic
gel. It mayby
bethe
more
comfortable
for
subjects
without
as shown skin
in
Figure
11b.
Both
the
MAE
and
Ag/AgCl
electrodes
can
monitor
EEG
signals,
recording
and
fluctuates
regularly.
The
same
fluctuations
are
observed
by
both
the
MAE
and but MAE
abrasion, skin allergy, and the bother of the gel drying in long term monitoring [2].
Ag/AgCl
electrodes,
as
shown
in
Figure
11b.
Both
the
MAE
and
Ag/AgCl
electrodes
can
monitor
EEG
could directly capture bio-signals without skin preparation (such as hair cutting and skin abrasion)
signals, but MAE could directly capture bio-signals without skin preparation (such as hair cutting
and application
of electrolytic gel. It may be more comfortable for subjects without skin abrasion, skin
and skin abrasion) and application of electrolytic gel. It may be more comfortable for subjects without
allergy, and
the
bother
of the
geland
drying
in long
term
monitoring
[2]. monitoring [2].
skin abrasion, skin
allergy,
the bother
of the
gel drying
in long term

Figure 11. EEG signals recorded by Ag/AgCl electrodes and the MAE: (a) closed and opened eyes
transition, and (b) blinking the eyes.

Figure 11. EEG signals recorded by Ag/AgCl electrodes and the MAE: (a) closed and opened eyes

Figure 11. EEG signals recorded by Ag/AgCl electrodes and the MAE: (a) closed and opened eyes
transition, and (b) blinking the eyes.
transition, and (b) blinking the eyes.

Sensors 2016, 16, 908

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4. Conclusions
Micro-needle array electrode was developed for bio-signals monitoring in this paper. The insertion
process of the MAE in the skin was simulated, and bio-signals recording performance, including EII,
EMG, ECG, and EEG, were investigated by experiments. We obtained the main conclusions:
(1)

(2)

The MAE, biocompatible for humans, can be fabricated by a thermal drawing method and
magnetron sputtering in mass production. The micro-needle tips can tear and insert the human
skin due to the stress concentration near the tips. When the compression force on the MAE is
larger than 1 N, EII of the MAE is about 85 K which is lower than that measured by Ag/AgCl
electrodes (120 K). EII slightly decreases with the insertion force at a given driving current
frequency. The MAE can record EII at a relatively low insertion force.
The MAE can clearly sense and record the surface EMG signals as well as Ag/AgCl electrodes.
The geometry of the MAE can be customized by a thermal drawing method based on a monitored
muscle to improve the selectivity of EMG and eliminate the crosstalk. The ECG features measured
by both the MAE and Ag/AgCl electrodes are all distinguishable in the static state. ECG signals in
the dynamic state measured by both Ag/AgCl electrodes and the MAE are seriously disturbed by
motion artifacts, but ECG signals of the MAE is more distinguishable than the signal collected by
Ag/AgCl electrodes. Both the MAE and Ag/AgCl electrodes can record EEG signals. The MAE
could directly capture bio-signals without skin preparation and application of electrolytic gel.

MAE seems to be a promising alternative electrode to conventional Ag/AgCl electrodes in

bio-signal monitoring. The comfort of MAE for patients during the long-term acquisitions and the
strength of the micro-needles need to be further improved. Additionally, before the proposed MAE
electrode is applied for EEG monitoring in hairy positions, a special fixture with a suitable pressure on
the head should be designed and fabricated.
Acknowledgments: This research is financially supported by the National Nature Science Foundation of China
(Project No. 51575543), Natural Science Foundation of Guangdong Province, China (Project No. 2014A030313211),
and Science and Technology Planning Project of Guangdong Province, China (No. 2015B010125004).
Author Contributions: Lei Ren designed the setup and wrote the entire manuscript. Qing Jiang and Lelun Jiang
managed the research and supervised the revision of the manuscript. Keyun Chen, Zhipeng Chen and
Chengfeng Pan participated in the experiments and data processing.
Conflicts of Interest: The authors declare no conflict of interest.

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2016 by the authors; licensee MDPI, Basel, Switzerland. This article is an open access
article distributed under the terms and conditions of the Creative Commons Attribution
(CC-BY) license (http://creativecommons.org/licenses/by/4.0/).