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1, FEBRUARY 2019
Abstract—This work presents a miniaturized µW-level im- ment of gastroesophageal reflux disease [3], cardiac pacemaking
plantable pulse generator (IPG) inductively powered at 430 MHz. [4], and curing stress urinary incontinence [5], etc. Conventional
Notches are intentionally applied to the incident power, which are IPGs are bulky with the battery taking up most of the unit, and
replicated to precisely control the timing of the output pulses. Fab-
ricated in a 180-nm CMOS process, the concise circuitry occupies the necessary leads are prone to cause various complications [1],
a pad-included footprint of 850 µm × 450 µm and achieves a qui- [4]. With this regard, recent research is interested in achieving
escent current consumption of 950 nA. To reduce the form factor, battery-less and leadless IPGs that can be directly implanted in
401–457 MHz MedRadio-band is utilized to realize the induction the specific anatomical region [5]–[8].
link. The finalized assembly achieves one of the smallest dimen- Most stimulation devices function in either current or voltage
sions (4.6 mm × 7.0 mm) for near-field IPGs with the Rx coil
size of 4.5 mm × 3.6 mm. Codesign of the rectifier and Rx coil modes. The current-controlled stimulation (CCS) provides pre-
accommodates the possible resonant frequency drifts in biologi- cise current control irrelevant of the load impedance. However,
cal tissues. In the benchtop measurement, a 430-MHz Tx coil is because the stimulator needs to comply with the worst-case elec-
demonstrated to operate the IPG at 4.5 and 4 cm proximities in trode/tissue impedance condition, the CCS renders the worse en-
the air and through water, respectively. An in vivo experiment has ergy efficiency in most clinical settings. The voltage-controlled
been performed, in which the IPG was implanted on the hindlimb
muscle belly of an anesthetized rat with the connective tissue and stimulation (VCS) regulates the stimulus in the voltage domain
skin sutured. The electrical stimuli induced the isolated ankle flex- and renders an excellent energy efficiency. Due to this reason,
ion at specific strengths and rates, and the experiment complies most existing commercially available IPGs are based on VCS
with the specific absorption rate regulations. This work shows the [9]. A physician identifying the appropriate range of stimulus
potential for applications requiring stringent form factors and high strength in advance and over time can eliminate the chance of
sensitivities.
overstimulation [5].
Index Terms—Electrical stimulation, energy-harvesting, im- Wireless power transfer is a substitute for the battery that pow-
plantable medical device (IMD), implantable pulse generator ers implantable medical devices (IMDs). Aside from far/mid-
(IPG), inductive coupling, neuromuscular stimulation, voltage-
controlled stimulation, wireless power transfer.
field coupling and ultrasonic transmission [10], [11], the near-
field inductive coupling is an attractive developing technology
I. INTRODUCTION [12], [13]. While prior induction-based IMDs were mostly pow-
ered at lower than 10s-MHz, the recent trend indicates that using
MPLANTABLE pulse generators (IPGs) have solved vari-
I ous critical clinical problems and improved the quality of
human life. Their applications include chronic pain relief [1],
hundreds-MHz can substantially reduce the form factor of the
implants [14]–[17]. The medical device radiocommunications
(MedRadio) service, i.e., 401–406, 413–419, 426–432, 438–
motor function recovery for spinal cord injuries [2], the treat- 444, and 451– 457 MHz, assigned by the federal communica-
tions commission has been used for the telemetry of IMDs [18],
Manuscript received August 12, 2018; revised September 19, 2018 and Oc- [19]. However, its use in the power link has not been reported
tober 21, 2018; accepted October 26, 2018. Date of publication November 9, to the authors’ knowledge. Unlike hundreds-MHz prior art that
2018; date of current version January 25, 2019. This work was supported in part
by NSF and in part by Broccolli Foundation. This paper was recommended by adopts on-chip coils [14]–[16], this work seeks to implement
Associate Editor A. Demosthenous. (Corresponding author: Hongming Lyu.) a miniaturized Rx coil on the PCB to minimize the cost. Also,
H. Lyu and A. Babakhani are with the Department of Electrical and Computer a discrete energy storage capacitor is regardless needed to be
Engineering, University of California at Los Angeles, Los Angeles, CA 90095
USA (e-mail:,hongminglyu@ucla.edu; aydinbabakhani@ucla.edu). assembled with the integrated circuitry.
P. Gad, H. Zhong, and V. R. Edgerton are with the Departments of In- In this paper, we propose a concise circuitry to realize an
tegrative Biology and Physiology, University of California at Los Angeles, energy-efficient voltage-controlled IPG with a quiescent (while
Los Angeles, CA 90095 USA (e-mail:,paraggad@ucla.edu; vzhong@ucla.edu;
vre@ucla.edu). not stimulating) current consumption of 950 nA. Inductive cou-
This paper has supplementary downloadable material available at pling at a MedRadio band achieves the wireless power link,
http://ieeexplore.ieee.org. where notches are intentionally applied to precisely control
Color versions of one or more of the figures in this paper are available online
at http://ieeexplore.ieee.org. the width and rate of the output pulses in an analog manner.
Digital Object Identifier 10.1109/TBCAS.2018.2879357 The energy-harvesting frontend circuitry takes account of the
1932-4545 © 2018 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission.
See http://www.ieee.org/publications standards/publications/rights/index.html for more information.
LYU et al.: 430-MHZ WIRELESSLY POWERED IPG WITH INTENSITY/RATE CONTROL AND SUB-1 μA QUIESCENT CURRENT CONSUMPTION 181
Fig. 5. The overall current consumption of the IC and that of the individual
blocks.
Fig. 7. (a) The 3D model of the implemented Rx coil. (b) The picture of the
as-fabricated PCB incorporating the Rx coil.
Fig. 10. The simulated dependence of RR E C and CR E C on IL O A D . Fig. 11. The resonant frequency drift in muscle medium.
Fig. 16. The output voltage waveform of the IPG in response to a 6 μs notch.
The inset shows the equivalent circuit model for the electrode.
has 4.7 μs and 1.4 μs delays compared to the starting and ending
points of the notch, respectively. Therefore, the duration of the
triggered stimulation is 3.3 μs shorter than that of the notch.
The spike at the onset of the pulse is an artifact due to parasitic
effects of the connection wire.
The voltage and corresponding current waveforms for the
96.7 μs and the 196.7 μs pulses are shown in Fig. 17. The
injected charge is temporarily accumulated on CDL so that
there appears a post-pulse voltage buildup. The voltage buildup
should not exceed the water delamination window, typically
about 1.4 V [29]. According to this constraint, the pulse width
should be kept below 300 μs. The current is obtained by record-
ing the voltage over the RS , which features an exponentially de-
caying waveform with the peak of approximately 3.2 mA (also
see Section III-E). A more comprehensive electrode model in-
cludes a charge transfer resistance, RCT , in parallel with CDL ,
which rapidly discharges the post-pulse potential in saline/tissue
[30]. In a typical case, RCT is around ten times as large as RS
[30]. With such RCT of 11 kΩ, the output voltage waveform
over multiple cycles is demonstrated in Fig. 17(e).
An LED can be optionally included at the output of the IPG to
indicate the occurrence of the output stimulation. In this work,
a green LED (APT1608LZGCK, Kingbright) is used. The IPG
is first tested in the air with the Tx power of 1 W. It shows the
maximum operating distance of 4.5 cm (Fig. 18(a)). The device
is then immersed in fresh water (εr = 80) at a 1.5 cm depth,
Fig. 15. (a) Picture of the Tx coil and (b) its S11 according to measurement. as the dielectric constant mimics that of the body. The Tx coil
operates the IPG at 2.5 cm above the water surface with a total
distance of 4 cm (Fig. 18(b)). The LED regulates the amplitude
capacitance, CDL , according to previous works as shown in the
of the output pulse at 3.1 V. 6.7 μs, Waveforms of 6.7 μs,
inset of Fig. 16 [26]–[28]. Two electrodes were immersed in the
16.7 μs, and 26.7 μs pulses respectively triggered by 10 μs,
phosphate buffered solution by approximately 5 mm. RS and
20 μs, and 30 μs notches are demonstrated in Fig. 19.
CDL were then characterized to be 1.2 kΩ and 0.6 μF, respec-
tively, with the Stanford Research System SR720 LCR Meter.
Due to the availability of the discrete components, RS of 1.15 D. Animal Experiment
kΩ and CDL of 0.6 μF in series were used as the load of the IPG. Selective activation of specific muscles with a miniaturized
A 6 μs notch was first applied to the Tx signal, which triggered implantable stimulator has been shown to correct foot drops
the output pulse as shown in Fig. 16. The monophasic waveform [31]. An in vivo experiment has been performed to test the use
186 IEEE TRANSACTIONS ON BIOMEDICAL CIRCUITS AND SYSTEMS, VOL. 13, NO. 1, FEBRUARY 2019
Fig. 17. Voltage (a, c) and the resulting current (b, d) waveforms for a 96.7 μs
pulse and a 196.7 μs pulse, respectively. (e) Three cycles of 96.7 μs pulses at
10 Hz rate.
Fig. 19. Output waveforms of an IPG with the LED loading the output.
Fig. 21. (a) Transient recordings of the induced force in response to 16.7 and
96.7 μs pulses. (b) The dependence of the induced force on the pulse width.
Fig. 20. (a) Animal experiment setup. The inset shows the implantation of
the IPG. (b) A closer view of the implantation site where the skin is sutured
covering the device.
TABLE I
COMPARISON OF RECENTLY PUBLISHED BATTERY-LESS IPGS
a
The maximum TP u l s e varies according to the charge injection capacity of different electrodes.
b
FP u l s e limit of 300 kHz is when the pulse width approaches zero.
c
TP u l s e and FP u l s e need to suffice equation (1)–(3). The combination of TP u l s e and FP u l s e affects the selection of RD I S .
d
According to the simulation setup.
e
The thickness of the epoxy encapsulation is not well controlled and is excluded from the calculation.
Note that Qch is accumulated on CBCK . Therefore, the passive IV. COMPARISONS AND FUTURE WORKS
discharging path should suffice the following relationship,
A comparison with recently published miniaturized IPGs
is presented in Table I. Due to the elimination of the coil,
VX /RD I S > Qch (3) ultrasound-based IPGs tend to have smaller form factors [7],
[8]. However, their operation typically requires the use of the
ultrasound gel. In addition, concerns were with its propaga-
A smaller RDIS in the assembly will ensure a smaller VX that tion through air-filled viscera such as the lung and bowel, and
does not evidently hamper the intensity of each stimulation. As obstructions such as bones. Passive circuits have also been in-
this work aims for a μW-level simulation load, RDIS is selected vestigated to realize energy-efficient IPGs [5], [33]. However,
to be 200 kΩ to ensure a minimum VX . CBCK is 47 μF in this they require sudden bursts of the Tx power, which are more
work. A relatively large CBCK helps to stabilize VX . prone to violate the SAR regulations. To achieve a high recep-
tion sensitivity, the proposed IPG consumes one of the lowest
static powers among active circuitry-based works. The use of
F. SAR Evaluation MedRadio-band contributes to the miniaturized form factor of
The SAR evaluation is performed in ANSYS. Placing the Tx the implant. Replacing the discrete components currently in
coil at a 3 cm distance from the human leg model, the simulated 0603 SMD packages to 0201 ones can further reduce the overall
10-g averaged SAR features the maximum value of 1.645 W/kg size by a large portion.
with the Tx power of 1 W, as shown in Fig. 22. The SAR The proposed work can be improved with the following re-
is well below the restrictions for localized exposure according gards. First, since this work uses the passive charge-balancing
to IEEE Std C95.1-2005, i.e., the lower tier of 2 W/kg used for DC-block, an offset voltage would build up over the electrode-
general public and the higher tier of 10 W/kg used for controlled tissue interface in an intensive stimulation setting, which needs
environments, e.g., medical implant use. to be analyzed and monitored [34]. Second, while this work aims
LYU et al.: 430-MHZ WIRELESSLY POWERED IPG WITH INTENSITY/RATE CONTROL AND SUB-1 μA QUIESCENT CURRENT CONSUMPTION 189
to demonstrate the operation with a relatively long Tx-Rx sepa- [10] J. Charthad, M. J. Weber, T. C. Chang, and A. Arbabian, “A mm-sized
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