I. INTRODUCTION
Electroceuticals that interface with nerves can be applied to both the central and
peripheral nervous systems. Neural electrodes targeting the central nervous system
typically interface by being implanted into the brain, whereas those designed for
the peripheral nervous system establish contact by wrapping around the nerve. Neural
electrodes that encircle peripheral nerves are referred to as cuff-type electrodes,
and securing these electrodes firmly to the nerve is critically important. If a cuff-type
electrode is attached too loosely, it may fail to acquire neural signals; conversely,
if it is attached too tightly, it can damage the nerve or even lead to nerve death
[1,
2].
Fig. 1 illustrates various nerve electrode fixation methods reported in previous studies.
Fig. 1(a) illustrates the suture-type fixation method, which is the most fundamental approach
for securing a cuff electrode onto a nerve. This method demands significant time and
effort from the surgeon and often necessitates assistance from additional personnel.
One major drawback is the difficulty in controlling the appropriate suture tension.
If the suture is too loose, the electrode may fail to maintain sufficient contact
with the nerve, leading to inadequate signal acquisition. Conversely, if the suture
is overtightened, it may compress or even damage the nerve tissue [3]. Additionally, due to the thin and flexible nature of the nerve electrode, the suture
holes can be torn during the fixation process. Fig. 1(b) illustrates a ratchet-based fixation method [4]. In this approach, a wide slit is formed across most of the electrode's width, and
an insertion tab with ratchet teeth on both sides is designed to pass through the
slit in only one direction, effectively locking into place. This mechanism enables
the surgeon to secure the electrode to the nerve with relative ease. However, the
ratchet teeth are spaced at fixed intervals, resulting in discrete steps for adjusting
the electrode-to-nerve fit. This limits the resolution of contact gap adjustment.
In addition, since the slit occupies the majority of the electrode's width, routing
conductive traces must be confined to the narrow regions between the slit edge and
the electrode edge. This constraint introduces design complexity and limits layout
flexibility. Fig. 1(c) illustrates the slit-insertion fixation method [5]. In this approach, a U-shaped slit is formed in the substrate, and the nerve becomes
engaged with the protruding structures created by the slit geometry, enabling passive
and automatic fixation. Despite its simplicity, this method presents several drawbacks:
it is mechanically unstable and prone to dislocation, offers a minimal contact area
between the electrode and the nerve, and may cause nerve folding due to interaction
with the electrode edges. Fig. 1(d) illustrates a clip-based fixation method for securing the electrode to the nerve
[6]. This approach enables the surgeon to attach the electrode with relative ease by
utilizing a mechanical clip. However, the clip occupies a substantial three-dimensional
volume and must be suspended from the nerve, which imposes a significant mechanical
load on the nerve tissue.
Fig. 1. Various previous fixation methods for cuff-type neural electrodes: (a) suture-method,
(b) ratchet-method, (c) slit-insertion method, (d) clip-method.
As demonstrated in previous studies, a simple and convenient fixation method is required
to secure electrodes to nerves effectively. Specifically, the electrode should be
fabricated on a thin and flexible substrate, without any bulky, clip-like three-dimensional
structures. It should provide maximal contact with the nerve's outer surface, and
the electrode-to-nerve gap should be continuously adjustable, rather than limited
to discrete steps. Moreover, the fixation process should be simple enough to be performed
by a single physician. To enable multimodal biosignal acquisition-such as sensing
core body temperature in addition to neural activity-a temperature transducer must
also be integrated into the electrode.
The local temperature around a neural electrode serves as a sensitive biomarker of
inflammatory and metabolic activity. Peripheral nerves, which have diameters of approximately
2 mm or less, are structurally delicate and highly susceptible to inflammation. Even
mild inflammatory responses can lead to nerve conduction loss or tissue degeneration,
ultimately resulting in permanent nerve injury. The integrated temperature sensor
enables continuous postoperative monitoring of localized temperature elevations that
may indicate inflammatory responses around the implanted device. Such inflammatory
reactions can persist or recur for days to months after implantation, emphasizing
the need for long-term thermal surveillance. Recent chronic wireless implant studies
have demonstrated that long-term temperature sensing can effectively track in vivo
inflammatory trajectories, supporting the translational value of this approach for
peripheral implants [7]. Furthermore, the integration of co-localized thermometry can extend beyond neural
interface monitoring to broader health applications. The system can provide real-time
detection of fever associated with infection or systemic illness, and it can also
track physiological temperature variations related to ovulation for reproductive health
management. These capabilities illustrate the versatility of temperature-integrated
electrodes, enabling both localized tissue monitoring and general health assessment
in freely moving subjects.
To address these requirements, this study proposes a thin, flexible neural electrode
that incorporates a novel nerve-fixation mechanism along with an integrated temperature
sensor.
II. NOVEL NEURAL ELECTRODE STRUCTURE AND FIXATION MECHANISM
Fig. 2 shows the architecture of the proposed neural electrode and its fixation onto the
nerve. Fig. 2(a) presents the top-view layout of the thin, flexible electrode. The electrode consists
of the following six components: circuit connection region (F1), nerve contact region
(F2), ratchet teeth (F3), plastic deformation element region(F4), temperature transducer
area (F5), and etched hole (F6). The nerve contact region (F2) includes four metal
contact patterns (e1-e4) that are exposed to make surface contact with the outer surface
of the nerve. Among these four metal patterns, two can be selectively used for neural
signal acquisition, or alternatively, two can be configured for current stimulation
and the other two for signal recording. Each metal pattern (e1-e4) is mapped one-to-one
to the corresponding patterns (i1-i4) in the circuit connection region (F1). The width
of each neural contact metal pattern (e1-e4) is 0.5 mm, and the spacing between adjacent
patterns is 1.5 mm. The length of the patterns is 10 mm, which is sufficient to fully
surround nerves with diameters of up to 3 mm. In previous animal experiments, the
diameter of the rat sciatic nerve was measured to be approximately 2 mm, and the electrode
design incorporated a margin to accommodate nerves with slightly larger diameters.
The temperature transducer area (F5) is designed for mounting a surface-mount thermistor
(0.6 $\times$ 0.3 $\times$ 0.3 mm, NTCG064EF104FTBX, TDK Corporation, Tokyo, Japan),
electrically connected through pins i5 and i6 of the circuit connection region (F1).
Thus, the circuit connection region (F1) exposes six signal lines (i1-i6) for electrical
connection with external circuits. It is designed with a line width of 0.3 mm, spacing
of 0.2 mm, and length of 4 mm, making it compatible with commercial connectors (505110-0692,
Molex LLC, Lisle, IL, USA). The triangular-shaped sawtooth structure (F3) has a base
length of 0.5 mm and a height of 1 mm. A Ti wire is inserted into the plastic deformation
element region(F4), and the cross-sectional width between points CC3 and CC4 is 0.3
mm. Etch holes were introduced during the fabrication process to reduce the time required
to release the neural electrode from the substrate. Each etch hole is square-shaped,
with dimensions of 50 $\mu$m $\times$ 50 $\mu$m.
Fig. 2. Proposed neural electrode (schematic, not to scale): (a) top-view layout of
the electrode structure, (b) illustration of the electrode fixed onto the nerve.
Fig. 2(b) shows a schematic of the proposed electrode's nerve fixation result. The electrode
is secured to the nerve through the following steps: Step 1. Pre-fold the plastic
deformation element region(F4) using a tool, aligning the folds precisely at the designated
positions F10 and F20. The sections F11 and F21 should be pre-folded upward along
the +z direction, forming an angle of approximately 45$^\circ$ with respect to the
xy-plane. Step 2. Wrap the nerve contact portion (F2), which includes exposed metal
surfaces, around the outer surface of the nerve to ensure surface contact. Step 3.
Loosely fold the plastic deformation element region(F4) by approximately 180$^\circ$
so that it engages with the ratchet teeth (F3). This mechanism allows the distal end
F9 to move in the D1 direction while preventing backward motion (D2). If the target
nerve has a relatively large diameter, the F3 section may also bend when F11 and F21
are folded. Step 4. Using two forceps, gently grasp the folded region of the plastic
deformation element (F9, F11, F21) with Forceps 1, and the opposite end F8 with Forceps
2. Pull F8 toward the D2 direction while maintaining a gentle hold with Forceps 1,
ensuring tight contact between the electrode and the nerve. Step 5. Finally, firmly
press Forceps 1 to fully fold the plastic deformation element region(F4) at the predefined
fold lines F10 and F20. This action brings the surfaces F9 and F30 into contact, locking
the structure in place and preventing relative motion between the electrode and the
nerve.
III. NEURAL ELECTRODE FABRICATION
Fig. 3 illustrates the fabrication process flow of the proposed neural electrode. The left
column presents cross-sectional views along the CC1-CC2 line, corresponding to the
flat regions of the device as marked in Fig. 2(a), while the right column shows cross-sections along CC3-CC4, which include the embedded
titanium (Ti) wire for fixation. The detailed process flow is as follows.
Fig. 3. Cross-sectional views of the fabrication process for the proposed neural electrode.
(p10) Trench formation: V-shaped trenches are etched into the (100) silicon substrate using KOH anisotropic
wet etching to define channels that accommodate the Ti wires. The trench for the titanium
(Ti) wire extends to the wafer edge. If not properly aligned with the $\langle$110$\rangle$
direction of the (100) silicon wafer, the trench becomes wider than designed due to
anisotropic etching errors. To precisely determine the $\langle$110$\rangle$ direction
on the silicon wafer, a fan-shaped test pattern was etched using KOH anisotropic etching
[8]. The trenches were then aligned to the experimentally determined $\langle$110$\rangle$
direction, and the alignment error was kept within 0.01$^\circ$.
(p20) Sacrificial layer deposition: In the final step, a sacrificial layer is deposited to enable the release of the
fabricated electrode structure. This layer consists of 500 nm of aluminum over a 100
nm gold base layer, deposited using thermal evaporator (UTS-150, Ultech Co., Ltd.,
Republic of Korea). During electrochemical etching, the aluminum is selectively dissolved
by applying a constant electrical potential. However, since etching proceeds non-uniformly
across the device, some regions may become fully released while others still retain
portions of the aluminum layer. In such cases, areas with remaining aluminum may become
electrically isolated, interrupting the flow of current required for complete etching.
To prevent this, the underlying gold layer remains intact throughout the process and
serves as a continuous conductive path, ensuring that all regions maintain electrical
connectivity until the release is complete. To verify proper trench formation, a cross-sectional
SEM analysis was performed. Fig. 4 presents an SEM image of the V-groove trench formed on the silicon wafer through
anisotropic etching.
Fig. 4. Images of the silicon wafer after trench formation: (a) photograph of the
wafer, (b) cross-sectional SEM image of the formed trench.
(p30) Ti wire placement and filling: The Ti wire inserted into the Si trench was straightened using a rolling process
on a stainless-steel jig. Trenches patterned on the Si wafer extended from edge to
edge across the wafer. Instead of using a single long Ti wire, multiple Ti wire segments
were inserted into the long trenches from edge to edge. Subsequently, liquid polyimide
(PI) was dispensed at the wafer edge of each trench, and capillary action drew the
PI along the trench. When excess PI was applied, it was wicked away with an absorbent
placed at the wafer edge. Through these steps, the trenches containing the Ti wires
became completely filled with PI, yielding a planarized surface across the entire
wafer.
(p40) Bottom PI patterning: A base layer of PI is spin-coated and patterned to define the lower structure of
the flexible electrode. All polyimide (PI) layers used in the electrode fabrication
were formed using a photosensitive polyimide (PSPI, HD-4100, HD MicroSystems, Parlin,
NJ, USA) [9,
10]. Because PSPI is a photosensitive polyimide, it can be directly patterned through
photolithography without the need for an additional photoresist coating.
PSPI (HD-4100) was spin-coated on the wafer using a spin coater (SSP-200) at 1,000
rpm for 10 s followed by 2,000 rpm for 30 s. Following this, a two-step soft bake
was performed on a hotplate (SHAMAL HHP-411, AS ONE Corp., Osaka, Japan) at 85 $^\circ$C
for 90 s and 95 $^\circ$C for 90 s. A mask aligner (MDA-600S, MIDAS SYSTEM Co., Ltd.,
Daejeon, Republic of Korea) exposed the wafer to UV light at 28 mW for approximately
7 s. Development used cyclopentanone as follows: i) spray at 100 rpm for 5 s, ii)
puddle at 0 rpm for 15 s (steps i and ii were repeated twice), iii) co-application
of cyclopentanone and AZ 1500 Thinner rinse for 5 s at 1,000 rpm, iv) AZ 1500 Thinner
rinse at 1,000 rpm for 10 s, and v) spin-drying at 3,000 rpm for 15 s. Finally, thermal
curing was performed on a hotplate at 200 $^\circ$C for 30 min and 375 $^\circ$C for
one hour.
Polyimide has been extensively evaluated for biomedical use. According to Constantin
et al. (Materials, 2019), various PI materials have shown non-toxic and stable performance
in vitro and in vivo, with successful medium-term implantations such as retinal and
intraneural electrodes [11]. Overall, the accumulated evidence supports the biocompatibility and bio-stability
of PI as a substrate for neural interfaces, although comprehensive long-term clinical
data remain limited.
(p50) Metal patterning: Gold (Au) patterns were formed to define the neural electrodes, interconnect lines,
and contact pads. A 500-nm Au film was deposited directly onto the PI base layer without
a Ti or Cr adhesion layer. No delamination of the Au film was observed throughout
fabrication and subsequent processing. Conventional photolithography was not suitable
for this process, as the bottom polyimide (PI) layer had a thickness of approximately
10 $\mu$m-substantially greater than the typical photoresist (PR) thickness of 1.5
$\mu$m-resulting in a large step height that interferes with uniform PR coating and
resolution. To overcome this limitation, the Au patterns were formed by thermal evaporation
through a shadow mask (Youngjin Astech Co., Ltd., Gumi, Republic of Korea) fabricated
from a 40 $\mu$m-thick nickel (Ni) sheet.
(p60) Top PI patterning: A second PI layer is applied and patterned to encapsulate the underlying metal traces
while leaving the circuit interface region (F1) and neural interface region (F2) exposed
for electrical access.
(p70) Structure release: The electrode structure was released by removing the aluminum sacrificial layer through
an electrochemical process known as anodic metal dissolution [12]. The wafer was immersed in a 1 M NaCl aqueous solution. The aluminum layer on the
wafer was connected to the anode through a 100 $\Omega$ series resistor, while a platinum
electrode, serving as the cathode, was immersed in the same solution. A constant voltage
of 2 V was applied between the two electrodes. Initially, a closed electrical loop
was established through the power supply, the series resistor, the aluminum layer,
the NaCl solution, and the platinum electrode. As the aluminum layer gradually dissolved
electrochemically in the NaCl solution, current flowed through the circuit. Part of
the applied 2 V potential dropped across the resistor (Vr), and the remainder appeared as the potential difference (Vw) between the aluminum and platinum electrodes. At the start of the process, Vw was approximately 1.2 V. After about 4 hours, when the aluminum had been completely
etched, Vw increased to 2 V. Once the aluminum forming the current path was fully dissolved,
the closed loop was disconnected, and the current dropped to zero. Consequently, Vr across the resistor fell to 0 V, while Vw rose to 2 V. Therefore, when a sudden increase of Vw to 2 V is observed during voltage monitoring, it indicates that the aluminum etching
process has been completed.
Finally, a temperature transducer (thermistor, 0.6 mm $\times$ 0.3 mm $\times$ 0.3
mm, NTCG064EF104FTBX, TDK) for body temperature measurement was mounted. To ensure
electrical insulation from the surrounding tissue, the entire thermistor was passivated
with PI. The thermistor was bonded to the metal pad using an anisotropic conductive
adhesive (ACA, DELO MONOPOX AC268, DELO Industrie Klebstoffe GmbH & Co. KGaA, Windach,
Germany) by thermo-compression at 190 $^\circ$C for 6 s.
To electrically insulate the thermistor from surrounding biological tissues, the thermistor
was passivated with a polyimide (PI) layer. A PI plate larger than the outer dimensions
of the thermistor was placed on top of it. Liquid PI was then injected along the sides
of the thermistor, allowing capillary forces to fill the gap between the substrate
and the top PI plate. The assembled film was soft-baked at 200 $^\circ$C for 30 min
and subsequently cured at 375 $^\circ$C for 60 min to complete imidization.
Fig. 5 shows the fully fabricated neural electrode, with key functional regions and their
outer dimensions indicated. The outer dimensions of the designated regions are approximately
29 mm $\times$ 15 mm. The thickness of the PI/Au/PI laminate layer is approximately
15 $\mu$m.
Fig. 5. Photograph of the fully fabricated neural electrode.
IV. ELECTRODE CHARACTERIZATION
Fig. 6 shows the test results of the fabricated electrode's fastening function on a nerve-mimicking
wire. The wire used in the test had a diameter of 1.5 mm. The electrode was secured
to the wire by folding the Ti wire, which serves as the plastic deformation element
of the electrode. Owing to its very thin structure, the fabricated electrode appears
slightly transparent.
Fig. 6. Fabricated neural electrode secured to a nerve-mimicking wire by folding a
plastic deformation element.
To evaluate the electrochemical characteristics of the neural contact of the fabricated
electrode, impedance, charge storage capacity (CSC), and charge injection capacity
(CIC) were measured. For the temperature transducer characterization, sensitivity,
linearity, and measurement error over the operating temperature range were assessed,
along with long-term leakage current measurements to verify the passivation performance
of the thermistor.
Fig. 7(a) shows the impedance of the fabricated electrode as a function of frequency, measured
using electrochemical impedance spectroscopy (EIS) with a Gamry Reference 600 device
(Gamry Instruments, Warminster, PA, USA) [13]. Since the primary spectral power of neural signals lies in the kilohertz range,
the electrode impedance is often represented by its value at 1 kHz. For an electrode
measuring 0.5 mm in width and 10 mm in length, the measured impedance at 1 kHz was
530 $\Omega$, corresponding to 2.64 k$\Omega$$\cdot$mm2. This value falls within the range reported in the literature for implantable neural
interfaces. For example, González-González et al. developed thiol-ene/acrylate SMP-based
cuffs with Au/TiN electrodes showing impedances of 1-3 k$\Omega$ (at 1 kHz), while
Dong et al. reported PEDOT:PSS recording electrodes on a parylene-C/Au platform with
approximately 1 k$\Omega$ (at 1 kHz) [14,
15].
Fig. 7. Electrochemical characterization of the fabricated electrode: (a) impedance
spectrum curve measured from electrochemical impedance spectroscopy (EIS), (b) charge
storage capacity (CSC) curve measured from cyclic voltammetry (CV), and (c) charge
injection capacity (CIC) curve measured from current pulse measurements.
Fig. 7(b) shows the cyclic voltammetry (CV) results for the fabricated electrode [16]. The voltage was swept at a rate of 100 mV/s using a Gamry Reference 600 device.
The CSC in the positive region of the curve was 79 $\mu$C/cm2, while that in the negative region was 151 $\mu$C/cm2, yielding a total CSC of 230 $\mu$C/cm2.
Fig. 7(c) shows the charge injection capacity (CIC) characteristics, which are commonly used
to evaluate the stimulation limit of an electrode [17].
In addition to the results obtained under the unwrapped condition, when the electrode
was wound around an insulated wire mimicking a nerve, the impedance slightly increased
to 577 $\Omega$ (2.87 k$\Omega$$\cdot$mm²), and the charge-storage capacities were
CSCA = 61.7 $\mu$C/cm2 and CSCC = 164.5 $\mu$C/cm2, resulting in a total CSC of 226.2 $\mu$C/cm2. The observed variability in the measurements reflects both reproducibility limits
and changes in the interface conditions between the electrode and PBS. As a representative
characterization of the electrode itself, measurements performed with the electrode
laid flat in PBS are preferable, because they exclude structural interface variations
introduced by the mounting geometry and thus better capture intrinsic electrode properties.
When the electrode is wrapped around a nerve phantom, part of the electrode surface
is masked by the phantom rather than being fully exposed to PBS, which alters the
effective electrochemically active area.
A stimulation current pulse was applied, and the resulting electrode voltage was measured
using an oscilloscope (MSOX4104A, Keysight Technologies, Santa Rosa, CA, USA). The
water window, defined as the stable potential range within which water electrolysis
does not occur, was conservatively set to $\pm$0.6 V. The negative boundary (-0.6
V) was reached when a current of 700 $\mu$A was applied, corresponding to a CIC of
14 $\mu$C/cm2.
The charge injection capacity (CIC) was measured by fixing the current pulse width
at 1 ms while gradually increasing the current amplitude and recording the resulting
electrode voltage. When the voltage reached the water electrolysis potential of 0.6
V, the applied current was 700 $\mu$A, which represents the upper limit of the charge
injection level applicable for neural stimulation at a 1 ms pulse width. Heo et al.
applied a biphasic current pulse to stimulate the rat sciatic nerve, using a pulse
amplitude of 300 $\mu$A and a pulse duration of 100 $\mu$s [18]. Thompson et al. also reviewed 33 studies related to neuroplasticity and rehabilitation
and reported that most studies used biphasic pulses with an amplitude of 800 $\mu$A
and a duration of 100 $\mu$s [19]. When normalized to a 1 ms pulse duration, this corresponds to an equivalent current
of approximately 80 $\mu$A. In our experiments on rat sciatic nerves, the rheobase
current and chronaxie time were measured to be 40.8 $\mu$A and 100 $\mu$s, respectively.
Taken together, these findings indicate that a charge injection capability corresponding
to approximately 800 $\mu$A at a 1 ms pulse duration lies within a practically applicable
range for sciatic or vagus nerve stimulation.
Fig. 8 shows the output response and measurement error of the thermistor integrated into
the fabricated electrode as a function of temperature. The electrode was placed in
a temperature chamber (PKK-50, Kambic d.o.o., Semič, Slovenia), and measurements were
performed at 1 $^\circ$C intervals over a range of 34 $^\circ$C to 43 $^\circ$C. A
platinum thermometer (CTP5000-250, WIKA, Klingenberg, Germany) and a precision temperature
reading device (UT-ONE B03B, Batemika d.o.o., Ljubljana, Slovenia) served as reference
sensors to determine the true applied temperature. The thermistor was connected to
a custom-designed ROIC, and its output was digitized using a time-to-digital converter
(TDC) [20].
Fig. 8. Thermistor characterization results: (a) TDC output as a function of reference
temperature with first-order interpolation, and (b) temperature measurement error
of the thermistor relative to the reference temperature.
Fig. 8(a) shows the TDC output as a function of the applied temperature. First-order linear
interpolation yields the regression equation y = 810.35x - 31403, with a correlation
coefficient (R2) of 0.998. The sensitivity, defined as the output change per 1 $^\circ$C variation,
is 810.35 digits/$^\circ$C, and the nonlinearity is 1.8 % FS. Fig. 8(b) presents the errors relative to the first-order interpolation, all of which are within
$\pm$0.1 $^\circ$C. These errors mainly arise from the nonlinearity of the thermistor,
the nonlinearity of the readout circuit, and electrical noise. The observed errors
conform to the performance standards for medical thermometers specified in ASTM E1112-00
[21]. According to this standard, the permissible error is $\pm$0.1 $^\circ$C for 37.0-39.0
$^\circ$C, $\pm$0.2 $^\circ$C for 35.8-<37.0 $^\circ$C and > 39.0-41.0 $^\circ$C,
and $\pm$0.3 $^\circ$C for temperatures below 35.8 $^\circ$C or above 41.0 $^\circ$C.
To evaluate the long-term stability of the thermistor passivation, leakage current
was monitored over a 150-day period. The fabricated electrode was immersed in phosphate-buffered
saline (PBS), with a voltage of 1.8 V applied to the thermistor, and a platinum electrode
placed in the PBS to measure leakage current. The PBS was left at room temperature,
which was around 25 $^\circ$C on average during the experiment. Throughout the 150
days, the leakage current remained below an average of 1 nA, indicating stable insulation
performance.
Table 1 compares the function and performance of the electrode developed in this study with
those reported in previous works. While ratchet fixation is more convenient than conventional
surgical suturing, it inevitably leaves a gap between the nerve and the electrode
[4]. This gap is determined by the pitch of the ratchet teeth and can only be adjusted
in discrete increments. The slit-insertion method, in which the nerve is placed between
protrusions formed by a U-shaped slit in the substrate, is simple but prone to loosening,
and the small contact area between the electrode and the nerve can result in poor
signal quality [5]. The three-dimensional clip method provides complete engagement with the nerve but
places a bulky structure on it, imposing an excessive mechanical load [6]. The electrode developed in this study does not require a separate three-dimensional
clip, enables broad contact with most nerve structures, and accommodates nerve diameters
of varying sizes in a continuous manner. While previous studies on electrodes employing
novel fixation methods featured a single sensing mode, the electrode developed in
this study supports a multi-sensing mode that also enables body temperature measurement.
Table 1. Performance summary and comparison with previous work.
|
|
This work
|
IEEE MEMS'14 [4] H. Yu
|
Adv.Sci.'17 [5] S. Lee
|
Adv.Sci.'22 [6] Rowan, C. C
|
|
Fixation method approach
|
Plastic deformation element + ratchet
|
Ratchet
|
Slit and insertion
|
Mechanical 3D clip
|
|
Characteristics
|
Continuously adjustable gap
|
Discrete adjustable gap
|
Incomplete fixation; limited contact area
|
Large 3D clip hanging on nerve
|
|
Additional sensing
|
O (Body temperature)
|
X
|
X
|
X
|
|
Substrate materials
|
Polyimide (PI)
|
Parylene
|
Polyimide (PI)
|
Polydimethylsiloxane (PDMS)
|
|
Thickness [$\mu$m]
|
15
|
15
|
-
|
105
|
|
Impedancea [k$\Omega$]
|
2.64
|
0.57
|
0.03
|
0.10
|
|
CSCb [$\mu$C/cm2]
|
79
|
-
|
56,400
|
-
|
|
CIC [$\mu$C/cm2]
|
14
|
-
|
-
|
-
|
|
Contact area [mm2]
|
4.975
|
0.0707
|
0.018
|
0.005
|
a Impedance conditions : @ 1 kHz, 1 mm2
b CSC condition : 100 mV/s
Electrochemical parameters such as electrode impedance, CSC, and CIC are key metrics
for evaluating suitability in neural interface applications. All impedance values
were normalized to an equivalent electrode area of 1 mm2 using the inverse proportionality relationship between impedance and electrode area
($R \times A$ = constant).
Although the electrode presented in this study demonstrates several advantages over
previously reported designs, it still shares a fundamental limitation common to other
wrapping-type electrodes. During implantation, the electrode must be manually wrapped
around the nerve, and the contact pressure must be carefully controlled-insufficient
tension may lead to unstable electrical coupling, whereas excessive pressure can cause
nerve compression or injury. To overcome this limitation, future studies should focus
on developing quantitative or self-adjusting fixation mechanisms that can automatically
achieve optimal wrapping force while minimizing dependence on the operator's skill.
The mechanical robustness of the Ti wire-based wrapping and locking mechanism was
evaluated through repeated deformation and preliminary retention testing. Although
the device is designed for single-use fixation, a complete fold-unfold cyclic test
showed fracture after about 30 cycles, confirming sufficient strength for implantation
while indicating a finite fatigue limit of the plastically deformable wire. In addition,
a PBS-wetted electrode wrapped around a nerve phantom exhibited no backward slippage
or disengagement during handling, demonstrating stable fixation. Nevertheless, future
quantitative evaluations-such as measuring pull-out force and slip onset load-are
required to further validate the fixation performance.
V. CONCLUSIONS
This study presents a thin, flexible neural electrode that integrates a plastically
deformable Ti wire fixation mechanism with an embedded temperature sensing element.
The fixation method enables continuous adjustment of the electrode-to-nerve gap, ensuring
secure contact without the discrete gap limitations of bulky three-dimensional clips
or conventional ratchet-based designs. A novel fabrication approach was developed
for mounting sub-millimeter Ti wires onto a 15 $\mu$m-thick PI-based flexible substrate.
The fabricated electrode was successfully applied to a nerve-mimicking wire, demonstrating
reliable fixation performance. Electrochemical testing yielded an impedance of 530
$\Omega$ (normalized: 2.64 k$\Omega$$\cdot$mm2), a CSC of 230 $\mu$C/cm2, and a CIC of 14 $\mu$C/cm2, which are within the range applicable to neural interfaces. The integrated thermistor
exhibited high linearity (R2 = 0.998) and sensitivity (810.35 digits/$^\circ$C) across 34-43 $^\circ$C, with errors
within $\pm$0.1 $^\circ$C, satisfying ASTM E1112-00 standards. Long-term PBS immersion
confirmed stable passivation, with leakage currents remaining below 1 nA over 150
days. By combining multimodal sensing with a simple, surgeon-friendly fixation mechanism
in a compact, flexible form factor, the proposed electrode addresses key limitations
of existing designs. This platform holds strong potential for future implantable neural
interfaces requiring both stimulation/recording and continuous physiological monitoring.
ACKNOWLEDGMENTS
This research was supported by the Bio & Medical Technology Development Program of
the National Research Foundation (NRF) funded by the Korean government (MSIT) (No.
NRF-2022M3E5E90822161331282099340103). This paper was supported by Korea Institute
for Advancement of Technology(KIAT) grant funded by the Korea Government(MOTIE) (RS-2024-00409639,
HRD Program for Industrial Innovation). This paper was supported by Education and
Research promotion program of KOREATECH in 2025. The EDA tool was supported by the
IC Design Education Center (IDEC), Korea.
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Sieun Lee received her B.S. degree in mechatronics engineering from the Korea University
of Technology and Education, Cheonan, Korea, in 2022, and her M.S. degree in mechatronics
engineering from the same university in 2025. Her research interests include low-power,
bio-applicable circuits.
Jong Pal Kim received his B.S. degree in mechanical design from the Department of
Mechanical Design, Chung-Ang University, Seoul, Korea, M.S. degree in mechanical engineering
from KAIST, Daejon, Korea, and Ph.D. degrees in electrical engineering and computer
science from Seoul National University, Seoul, Korea, in 1995, 1997, and 2003, respectively.
He was a member of research staff at Samsung Advanced Institute of Technology (SAIT)
from 2001 to 2019. In 2020, he joined the Faculty of School of Mechatronics Engineering,
Korea University of Technology and Education, Cheonan, Korea. His research interests
include low power and low noise analog integrated circuits for biomedical and MEMS
applications.