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Wireless Power Transfer Strategies for Implantable Bioelectronics

CHAPTER-1

INTRODUCTION

1.1 Introduction
In this chapter we will learn about the aim of the seminar, objective of seminar,
motivation for work, and organization of report.
1.2 Aim of seminar
Aim of the seminar is to provide information about wireless power transfer strategies
for implantable bioelectronics and how various implantable bioelectronics work.
1.3 Objective of seminar
The objective of this seminar is to understand how implantable bioelectronics can create
change in the medical field with wireless strategies.
1.4 Motivation for work
Wireless implantable bioelectronics helps people discover or rediscover a better quality
of life through improved strategies.
1.5 Organization of report
Chapter 1:
In this chapter we will discuss about the aim of the seminar, Motivation for work and
organization of the report, and brief description about the topic to be discussed furthermore
Chapter 2:
In this chapter we will learn about various power transfer strategies that are used in
implantable bioelectronics with appropriate figures explaining about them.
Chapter 3:
In this chapter we will give brief explanation about various implants that use wireless
power transfer strategies with appropriate diagrams

Chapter 4:

In this chapter we discuss about various safety measures and regulations to be used to
implant bioelectronics which use wireless power transfer strategies.

Chapter 5:
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In this chapter we will discuss about conclusion for the thesis of all chapters that are
discussed and future scope.

1.6 Conclusion
This chapter ends with discussion about the aim of seminar, motivation for work and
organization of report.

CHAPTER 2
WIRELESS POWER TRANSFER STRATEGIES
2.1 Introduction

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In this chapter we will learn about the history of wireless power transfer strategies and
various wireless power transfer strategies for implantable bioelectronics with appropriate
figures explaining about them.
2.2 History of wireless power transmission
Michael Faraday’s discovery of EM induction in 1831 paved the way for transferring
electrical energy from one coil to another without a conducting medium. Transformers were
built based on this principle and were the first devices to transfer power without power delivery
circuits. The only drawback was that the need for strong coupling limited the separation
between the coils. Hence, the transformers were solely used for isolation, stepping up and
stepping down voltages. Transmitting power over large distances was proposed much later by
Heinrich Hertz and Nikola Tesla at the dawn of the 19th century. Tesla’s work was mainly
focused on resonance and its use in efficient wireless power transfer. Developments in wireless
power transmission (WPT) were slowed down during the first half of the20th century, as it was
well understood that efficient power transfer is possible only by channelling the EM waves into
an arrow beam, and such beams were impractical for even the smallest wavelengths produced
by the generators available at that time. The advent of high-frequency oscillators provided
much needed impetus to rekindle works on the WPT. Development of high-frequency
microwave power links was a hot topic in the 1960s and such links were considered for
potential applications in space and solar energy beaming. Coincidentally, around this time,
fully implantable devices such as implantable pacemakers were starting to be conceptualized,
and the need for wireless power transfer became apparent.

New developments in microwave power beaming were not directly useful for implants
due to two reasons. First, the power transfer range was so short that the receiver was in the near
field of the transmitter. Secondly, the power density was limited by the tissue exposure to the
EM fields. Hence a near-field system using EM induction principle was a likely candidate for
use in IMDs. However, the design ideas from recent developments in long-range power
transmission, like resonant tuning and impedance matching, were adopted for efficient
operation. Some of the first works on transcutaneous power transfer were aimed at powering
cardiac devices, all of which used the principle of EM induction, combined with resonance at
the transmitting and receiving coils - a method now known as the near-field resonant inductive
coupling.

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With rapid leaps in technology over the last few decades, amyriad of methods have
been proposed to power the implanted devices wirelessly. Near-field inductive coupling, near-
field capacitive coupling, ultrasonics, mid-field and far-field EM coupling are the various
methods proposed to power implantable devices. Here we discuss in detail about first three
strategies and briefly discuss about mid field and far field EM coupling.
2.3 Near-field resonant inductive coupling

The near-field resonant inductive coupling (NRIC) scheme is the oldest and the most
established power transfer method. It works on the principle of EM induction.

Figure 2.1. Schematic of the near-field inductive power transfer method.

A transmitting coil (TX) placed close to the skin produces a time varying magnetic
field, which induces an electromotive force (EMF) in the receiving coil (RX), placed inside the
body as shown in Figure 2.1.

The TX and RX are loosely coupled because their separation is comparable with the
dimensions of RX. Under such conditions, only less than a tenth of the magnetic field produced
by the transmitter is utilized for inducing EMF at the receiver. Thus, the efficiency of the power
transfer capability of the scheme needs to be addressed. The induced emf E at RX is given by

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From (1), we can infer that the power transfer capability is improved from the first principles
as follows:
(i) Increasing the magnetic field strength
● by increasing the transmitter current (limited by safety limits on magnetic field strength
in tissues)

● by reducing the TX-RX separation (constrained by the implant application)

(ii) Increasing the rate of change of magnetic field


● by increasing the operating frequency (limited by power reflection and tissue losses)

(iii) Increasing the flux linkage between TX and RX


● by reducing the TX-RX separation (constrained by the implant application)

● by ensuring proper spatial alignment of TX and RX

Considering these design requirements, the above-listed improvements in Power


Transfer Efficiency (PTE) can be made to the NRIC power link. The induced EMF
monotonically increases with the magnitude of TX current and frequency of operation, but is
limited by the maximum field strength for safe operation in tissues and large tissue attenuation
at high frequencies respectively. Hence, the proper choice of excitation frequency and strength
is crucial to generating large EMF, sufficient for the end implant application.

2.4 Near-field capacitive coupling

The NCC scheme is the capacitive counterpart of the NRIC scheme and works on the
principle of electric field coupling between two pairs of conductors, one each for the forward
and reverse current paths as shown in Figure. WPT across the tissue layer is enabled by the
displacement current between the conductors which needs no physical medium to support it.
The voltage excitation between the pair of external conductors TX, refer Figure generates
extremely low currents, due to a high mutual impedance between them. However, when
another pair of conductors RX as in Figure are brought to close the loop, the mutual impedance
reduces and draws current from source.

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Figure 2.5. Schematic of the NCC method.


In the process, the current drawn is mirrored to the implant device, thus powering it
through this capacitive coupling. The impedance formed by the capacitive reactance between
the TX and RX is large even for very small separations between them. Hence, the current drawn
from the source is expected to be low, thus limiting the power transfer capability.
To make it suitable for implantable applications, specific design improvements have to
be implemented. First, let us look at how the NCC powering scheme can be improved from the
first EM principles.

Figure 2.6. Improving the power transfer capability from the first EM principles.

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Consider a pair of metallic patches as shown in Figure 2.6 with a small separation D
(placed on either side of the skin with tissue thickness D (<5 mm) for both TX-RX pairs) and
an effective area A each. When the time-varying voltage, V (t), excites the patches, the current
from the source is supported at the conductor discontinuity by the displacement current
between the conductors.
The electric field between conductors induces the conduction currents in the skin and
the surrounding tissues. These displacement and conduction currents, which form the basis of
NCC wireless power transfer scheme are given by

The conduction current causes undesirable tissue losses which should be minimal, hence its
amplitude needs to be smaller. The displacement current needs to be larger for efficient power
transfer. From (5), we can see that the displacement current, and hence the power transfer
capability can be improved from the first principles as follows:
(i) Increasing the electric field strength
● by increasing the transmitter excitation voltage (limited by safety limits on electric field
strength in tissues)

● by reducing the TX-RX separation (limited by the implant application)

(ii) Increasing the rate of change of electric field


● by increasing the operating frequency (limited by the tissue losses)

(iii) Increasing the magnitude of electric field


● Increasing the area of the conductors (limited by the implant application)
Whereas, from (6), we see that decreasing the conduction current requires reducing the
effective area of the conductors or reducing the TX excitation voltage, or a combination of
both. Thus, an optimum has to be achieved to meet these desirable, yet a conflicting set of
requirements to transfer wireless power efficiently. The improvements mentioned above are
not easily realized as the implant dimensions, and the TX-RX separation is controlled by the
implant location and requirements based on its application.

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2.4.3 Challenges and solutions


With optimized NCC links, there are still challenges that need to be addressed. The
implant application requirements are generally stringent, posing challenges for system level
implementation of the NCC link. The challenges and solutions are addressed below.
(a) The wireless power transfer efficiency in NCC link is very sensitive to the separation
between the TX and RX even at lower separations due to the weak capacitive coupling
(capacitance formed by the metallic patches of implantable dimensions is small (<1 pF), even
for a few millimeters separation), unlike the NRIC link where it is significant only at larger
separations (beyond 10 mm). Hence power fluctuations at the implant tend to be more in NCC
links when compared to NRIC links.
● Closed loop power transfer by constant monitoring of the input reflection helps sustain
the received power at the implant. This is achieved by varying the transmit power
accordingly.
(b) The rectification at larger frequencies (over 30 MHz) tends to be less efficient than at lower
frequencies. Hence the end to end power transfer efficiency of the NCC link is generally lower
than the NRIC links.
● Efficient rectification strategies at RF frequencies using multiple Schottky diode stages
and novel circuit techniques in CMOS implementation have been reported. Using such
strategies will help improve the rectification efficiency thereby mitigating RF-DC
conversion losses. The only drawback is that the narrow band of frequencies, to which
the rectifier is tuned to operate efficiently, limits the operating bandwidth of the NCC
link.
2.5 Ultrasonic energy transfer
The ultrasonic energy transfer scheme uses propagating ultrasound waves (freq>20 kHz) to
carry energy wirelessly. It, however, needs a medium (not necessarily conductive)to propagate,
unlike the EM methods which can transfer the energy through a vacuum. For implantable
applications, ultrasound waves can carry energy while propagating through tissues to an
implanted device where it is converted to electrical energy using a piezoelectric transducer. A
typical ultrasonic energy transfer system is shown in Figure 2.8. The TX is an ultrasonic
oscillator which is electrically excited to generate surface vibrations resulting in acoustic
pressure waves typically in the frequency range of 200 kHz to 1.2 MHz. The RX is a

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piezoelectric energy harvester implanted inside the body within the main radiation lobe of the
TX and converts the acoustic energy back into the electrical energy.
The pressure field is to be directed towards the RX to capture most of the radiated
energy. Directivity depends on the ratio of the transducer perimeter to the wavelength An
ultrasonic transcutaneous energy transfer (UTET) system using a continuous wave 650 kHz.
Gaussian shading generates an ultrasonic pressure field that exhibits advantages over a Bessel
or uniform excitation for the UTET implementation.

Figure 2.8. Schematic of the ultrasonic energy transfer method.


According to the Huygens principle, each point on the transducer can be treated as an
independent source of radiation, and the acoustic field pattern can be found as the vector sum
of all the point radiating sources. The pressure field P at an observation point L(x, y, z) is given
by the Rayleigh integral in (11).

Above integral is a surface integral where R is the distance from the infinitesimal point
source to the observation point; u0 is the vibration velocity amplitude; λ is the wavelength of
pressure wave in the medium; c0 is the phase velocity of the wave; ρ0 is the density of the
medium; w is the angular frequency and k is the wave number.
A Gaussian beam has reduced pressure variations in the near-field, suppressed side
lobes in the far-field and an indistinguishable near-field from the far-field. It is claimed that

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the ultrasound based power transfer scheme has lower power fluctuations. This is caused by
variations in alignment when compared with the near-field power transfer schemes the far-
field. It is also claimed that the ultrasound based power transfer scheme has lower power
fluctuations. This is caused by variations in alignment when compared with the near-field
power transfer schemes.
2.5.3 Challenges and solutions
The challenges and solutions are addressed below.
(a) Different organs in the human body have different densities and acoustic impedances. The
acoustic impedance can be so high (as in bones) that all the ultrasound wave energy will be
reflected back. Also, the attenuation of the pressure field by the soft tissue layers decreases the
field intensity exponentially with increasing frequency and distance. This limits the usage of
UTET for powering the implanted devices only in certain body locations.
● The choice of the optimum operating frequency as given by (13) and the proper
location of the implant can be implemented to resolve it to an extent.

(b) The long-term effects of tissue vibrations caused by the propagating ultrasound waves from
the TX to the RX in a UTET system can lead to adverse human safety issues.
● Since the ultrasonic energy transfer scheme is being investigated as an alternative to
its EM counterparts for powering fully functional implantable neurotech devices inside
humans, long-term safety effects of tissue vibrations need to be studied chronically to
comply with the FDA requirements for ultrasound based systems.

2.6 Brief description of mid-field and far-field wireless power transfer


Mid-field Wireless Power Transfer EM mid-field wireless power transfer scheme builds on the
shortcomings of the conventionally used WPT schemes for a miniaturize implant, where the
separation of the TX from the RX is of the order of one wavelength at the mid-field frequency.
In such a similar scenario in the NRIC scheme, where two weakly coupled inductive coils are
placed in the multi-tissue layer environment separated by few centimetres, the WPT occurs at
a very low PTE at the frequencies typically lesser than a few MHz. Better efficiency for such
distant miniature RX implants is achievable by combining the near-field inductive and the far-
field radiative modes of a TX at the low-GHz mid-field frequency range.

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Figure 2.10 Wireless energy transfer using the midfield powering scheme.
(A) Schematic for power transfer to a miniature sub-wavelength coil implanted on the surface
of the heart. Magnetic field (right) in the air and (left) coupled into the multi layered tissue. (B)
Layered view of the magnetic field in different tissue layers showing the waves converging at
the implanted coil.
(C) Spatial frequency spectra at depth planes.
This is done by a proper system design, where an optimum mid-field operating
frequency is chosen based on the implant depth and the type of tissue layer, so that the
transmitted waves converge at the RX coil implanted inside the tissue as shown in Figure.
The focus is to maximize PTE by following two design rules:
(i) Solving the impedance matching problem between the load and the RX by use of
electrical impedance matching techniques.

(ii) Designing a TX source that maximizes the EM energy coupling to the implanted
RX structure.

Though the mid-field WPT scheme has been derived for maximizing the PTE of a deep
seated mm-scale RX implant, there are several challenges that have to be met before this
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strategy can be deployed for usage in modern implants. Few design challenges and their
prospective solutions are listed below.
(a) Though the overall PTE of the mid-field WPT system is claimed to be maximized compared
to the conventional WPT systems for deep tissue micro implants, the delivered power levels
are still lower (few mWs) and the applications are severely limited.
(b) Long-term effects of mid-field wireless powering are yet to be reported after conducting
chronic studies designed for its possible applications. To date, only acute demonstrations of
powering deep-seated implants using this scheme have been reported. Proper EM safety
analysis will provide us with a better understanding of this powering scheme to be used for
wireless IMDs.
Far-field Electromagnetic Coupling The far-field electromagnetic coupling (FEC)
scheme works on the principle of EM radiation, where a RX antenna is placed at a large
separation from the TX antenna. In the far-field zone of an antenna. The FEC wireless powering
strategy has been thoroughly investigated for long-range power transmission in the free-space
over the last decade but its implementation for powering biomedical implants has remained
relatively less researched.
2.7 Conclusion
This chapter ends with a brief explanation about various wireless power transfer strategies used
in implantable bioelectronics.

CHAPTER 3
VARIOUS IMPLANTS BASED ON WIRELESS POWER
TRANSMISSION

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3.1 Introduction
Various wireless power delivery schemes reported for cardiac, cochlear, cortical,
retinal, peripheral, spinal and optogenetic implants are discussed briefly in the following
chapter.

3.2 Cochlear implants


As one of the mature implant technologies, the cochlear implants (CIs) are widely used
to restore the auditory senses in the hearing-impaired or deaf people. More than 200,000
patients have received CIs worldwide, with minimal cases of failure. The external unit of the
modern CIs consists of a microphone and an audio processor which is worn behind the ear
similar to a hearing aid. The auditory signal processed from the recorded sound are wirelessly
sent to the implant unit that electrically stimulates the remaining auditory nerve fibers in the
cochlea as shown in Figure 3.1(A).

Figure 3.1 (A) Implant RX coil positioned beneath the skull behind the ear in cochlear implant
being powered by an external TX coil using the NRIC scheme
(B) The orientation of the TX-RX coils pair is aligned using the permanent magnets.
The activity of the nerve fibers is then transmitted to the brain, which interprets them
as auditory events, identical to the mechanism in the normal hearing. The implanted stimulator
unit is powered using a magnetically coupled coil pair (NRIC scheme) with the TX coil in the
external CI unit positioned over the scalp on the head behind the ear as shown in Figure3.1 (A)
for positioning. The stimulator unit provides current pulses with amplitudes ranging from 10
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uA to 2 mA at various electrode sites (typically between 8 to 24 electrodes) corresponding to


the speech signal acquired by the external processing unit.
The power budget of the link depends on the active usage of the implant and can vary
between 20 mW and 40 mW with peak power consumption being required for simultaneous
electrode stimulations. Current day CIs have successfully restored the listening capabilities
with state of the art speech processing technologies enabling multi-lingual speech perception.
A commercially available wirelessly powered CI device by the manufacturer MED-EL is
shown in Figure 3.1 (B). Permanent magnets in the centre of coils are used to align the
orientation of the TX and implanted RX coils.
3.3 Retinal implants
Electrical stimulation can help achieve visual perception for Retinitis Pigmentosa (RP)
and age-related macular degeneration (AMD) patients with total blindness or fading tunnel
vision. Completely wireless retinal implants (RIs) have been functionally demonstrated, and
technological advancements have led to provide artificial vision in RP victims post-
implantation surgeries. Variations in stimulation (retina,the optic nerve and lateral geniculate
nucleus) for retinal prosthesis influences the positioning of the implant device and the wireless
electronics associated with it.
For the case of epiretinal implants, the implant coil is placed over the eye, whereas for
the case of subretinal and suprachoroidal implants, the implant coil is placed beneath the scalp
and a platinum wire connects the coil to the retinal stimulator. Figure 3.2 shows the ARGU II
retinal prosthesis system developed by the Second Sight Medical Products, which is an
epiretinal implant as in Figure 3.2 (C) that consists of a RX coil, electronics, and a 60 platinum
electrode array (6×10 grid) to electrically stimulate the surviving retinal neurons, surgically
implanted in and around eye demonstrated in Figure 3.2 (B). The external part of the system
as in Figure 3.2 (A) includes the glasses which have a miniature video camera and TX coil
attached, a video processing unit (VPU) and a cable. The TX coil transmits the data and
stimulation commands obtained from the VPU processed video images captured by the camera,
to the RX coil mounted on the side of the eye (TX to RX separation 1 inch or closer) in RI
strapped around the eye. The RI is powered (≈45 mW) using the same NRIC link as for the
data using amplitude modulation technique at transmit frequency of 3.156 MHz.

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Figure 3.2 ARGUS II retinal prosthesis system.(A) Wearable external unit with the camera
attached to glasses and the TX coil on the corner.(B) Implant RX coil encirculating the eyeball
being powered from an external TX coil using the NRIC scheme in the epiretinal implant.(C)
Actual retinal implant device (A-C Adapted with permission from Second Sight).
3.4 Cortical implants
Microelectrode array (MEA) recordings from different regions of the human cortex
have enabled us to utilize brain circuits for improving the lives of neuromotor disease patients,
amputees, and the spinal cord injury victims. Though completely wireless, sustainable cortical
implants have only been recently demonstrated in pre-clinical trials in non-human primates;
various groups are making progress. Figure 3.3 shows a 100-channel rechargeable Li-ion
battery powered cortical implant system demonstrated to safely capture and deliver broadband
neural data over a year of testing.
The battery is charged on every 7-hour cycle via an NRIC TX-RX link designed at 2
MHz. 100 electrode MEA with individual electrode impedances ranging between 100 to
800kΩis used to interface and record the data, which is transmitted by wireless data link using
FSK modulation at 24 Mbps to a data RX located at a distance of >1 meter. During the normal
operation, the implanted device (weighing a total of 44 .5 g, 7.4 g from battery/30.6 g from
titanium packaging/6.5 g from PCBs and electronic components) consumes ≈90.6mW of
power and requires 30 minutes of recharging the battery for an external charging system, placed
≤3 mm near the implanted device with the charging currents of 80 mA.

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Broadband neural recordings for over 27 months have been chronically validated in
primates, using this wireless cortical implant with safe operation. For the high power cortical
implant applications (power delivered to RX ≈100 mW), NRIC scheme still remains preferred
method.

Figure 3.3. Architecture, assembly and functions of hermetically sealed, wireless, battery
powered neural interface for the cortical implant (A) The wireless neural interface uses the
NRIC scheme for recharging Li-ion implant battery and data telemetry through a
transcutaneous link. (B) The detailed view of the neurosensor device (to scale).

3.5 Peripheral nerve implants


Peripheral nerve implants (PNIs) can provide patterned stimulation to restore the
dysfunctional motor and sensory functions in the limbs. The approach is to record and classify
the nerve signals using a recording implant and then transfer the signals wirelessly to the
stimulator implant, thus bypassing the denervated muscle region (proximal nerve injury). Both
the recording and stimulation implants need wireless powering and data transfer for the
completely implantable system. Functional muscle stimulation require up to 10mA current for
electrode impedances varying between 500Ω to 1kΩ, which corresponds to 100mW of
delivered power levels to the stimulator implant. The neural recording implant needs 35mW of

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rectified power for amplification, analog-to- digital conversion, and digital logic functionality.
Figure 3.4 (A) shows a diagram of an upper human limb with the possible positioning of the
external and implanted stimulator and recording units. Given the wireless power requirements
>100mWs by the PNIs.

Figure 3.4 Proposed peripheral nerve prosthesis in the upper human limb. (A) The positioning
of the recording and stimulator implant units for wireless powering and data transfer with the
external units using the NRIC scheme.(B) The actual stimulator implant device with Pt-Ir
electrodes. (C) The external decoder with the class-E amplifier.
A TX (30 mm diameter) – RX (20 mm diameter) coil link pair is designed at 1 MHz
in for wirelessly powering the stimulator implant demonstrating the functional muscle
stimulation based on the factors like human arm size, tissue losses, separation, etc. For the
subcutaneously implanted RX in a rodent model, the measured delivered power was reported
to be 10 mW for 10 mm separation, and 127 mW for 5 mm separation (PTE of 65.8% without
rectification). Thermal and radiation safety have also been demonstrated for maximum
delivered power levels to the PNI functioning inside the animal model. Recently, an ultrasonic
based wireless backscatter system was demonstrated in for powering and communicating with
the mm-sized implanted devices transmitting electromyogram (EMG) and electroneurogram
(ENG) signals from the peripheral nervous system in a rodent model.

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Vagus nerve stimulation (VNS) has been used as an adjunctive therapy for decades to
treat intractable epilepsy and depression and is now under active research for other illnesses
including Alzheimer’s disease, migraines and obesity. Typically, a VNS system consists of an
implantable pulse generator (IPG) that delivers electrical impulses in the form of stimulation
patterns via electrodes that are attached to the vagus nerve. The battery life of such IPGs is
between 1 and 16 years depending on the signal amplitude, stimulation frequency and the
duration of stimulation cycles. Leading commercial VNS device manufacturer includes
cyberonics, their battery-powered AspireSR has been implanted in more than 80,000 patients
for epileptic seizures control and management. Wirelessly powered VNS systems, ranging
from the electrical stimulation of the splanchnic nerves for treating obesity, to the closed-loop
modulation of the inflammatory reflex for the treatment of chronic inflammation, have been
proposed over the last decade. The VNS device is either directly powered using the inductively
coupled coil pairs (NRIC scheme), or uses a lithium-ion rechargeable battery that integrates
the RX WPT system for wireless recharging from time to time. With the advancement of the
neural stimulator technology, tiny micro stimulators with integrated electrodes have been
developed that can directly be attached to the nervous system.
Microstimulators, combined with the wireless technology allow typical IPG, leads, and
electrodes to be replaced with a single device that receives power and stimulation data from an
external controller. The closed loop control VNS implemented in Figure 3.5 for entire device
information is achieved using the implant electronic assembly that consists of a RX coil for
receiving power, and sending and receiving data to and from the outside powering and
programming device (TX coil in wearable energizer), an electronic circuit that autonomously
stimulates the neural tissue, and the microstimulator battery. The energizer and microstimulator
coils are tuned to resonate around (131 ±4) kHz, delivering ≈15 mW of power through the magnetic
coupling between TX-RX coils.

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Figure 3.5 SetPoint Medical’s wirelessly rechargeable closed-loop vagus nerve stimulation
system using NRIC powering scheme for charging micro regulator battery. (A) The
implantable microstimulator unit with integrated RX coil, battery and electrode pads. (B) The
protective, ‘snap-on’ pod used to hold the microregulator in place. (C) The microregulator in
pod. (D) The external wearable energizer (rechargeable battery with the TX coil and electronic
circuitry) to be worn around the neck. (E) The prescription pad for controlling manual current
inputs. (F) Illustration of a head shot showing the location of the implant unit placement for
electrically stimulating the left vagus nerve to treat chronic inflammation.
The data is transmitted back to the source by dynamically loading the resonant circuit
with impedance, thus creating a change in RX load seen by the external driver. Based on the
data from the implant (microstimulator battery level, charging TX signal strength, etc.), the
patient can align the externalenergizer to the microstimulator implant so as to facilitate
maximum delivery of power. SetPoint Medical plans to begin clinical trials in 2017 with its
proprietary fully wireless VNS system.
3.6 Conclusion:
This chapter ends with a brief explanation about various implants based on wireless
power transmission.

CHAPTER 4
SAFETY MEASURES
4.1 Introduction
In this chapter we discuss various safety measures to be used to implant bioelectronics
which use wireless power transfer strategies.
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4.2 Electrical safety


Wireless powering and telemetry systems barring the UTET method use
electromagnetics for transferring energy and data, thereby introducing electrical hazards. EM
energy, when not in check, can cause tissue burns and unintended stimulation of tissues and is
a major health hazard that can even be fatal (large induced currents in critical tissue path such
as the heart or certain nerves). Tissue burns are caused by heating at the electrodes or the
electromagnetic interfaces or the direct currents induced by the EM fields penetrating into the
tissue. Tissue stimulation, on the other hand, is the result of cell response to external electric
and magnetic fields. The first direct way to mitigate tissue burns is to limit the EM field
exposure. The acceptable limit of field exposure varies with different tissues as their dielectric
properties vary and the tissue is dispersive as well.
The following safe operating conditions are recommended with respect to static magnetic field
strength, RF heating and time varying magnetic fields:
1. Normal exposure to static magnetic field should not exceed
• 8 Tesla for adults, children, and infants aged >1 month
• 4 Tesla for infants aged ≤1 month
2. Specific absorption rate (SAR) for first level controlled operating modes should not exceed
• 4 W/kg averaged over whole body (Whole body SAR)
• 2 W/kg averaged over 10 g of tissue absorbing the most signal (Partial body SAR)
• 3.2 W/kg averaged over head (Head SAR)
4.3 Biosafety
The materials used in the wireless power transfer scheme need to be completely biocompatible
or enclosed in a leak proof biocompatible casing for chronic applications such as biomedical
implants. Copper is not biocompatible, and gold potentially leaches or delaminates, and hence
both are not desirable metals for long term implants. Consequently, making high-quality factor
antennas for implantable applications is not always that straight forward. Usually, the design
practice is to encapsulate the metal interface with a polymeric biocompatible material such as
Polydimethylsiloxane (PDMS) or NuSil as shown in Figure 4.1. Characterization of bio-
encapsulating materials and analysis of their electrical properties (dielectric constant and loss
tangent) needs to be done as it will affect the EM behaviour of the antennas.
4.4 Physical safety

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Physical safety refers to the mechanical structural integrity or interface to the tissue for the
implant. Wireless and associated electronics occupy a significant percentage of the implant
volume, and hence have a key say in the mechanical design of the implant.

Figure 4.1. Flexible EM interfaces proposed by (A). Bio-encapsulated Cu patches in for


capacitively coupled WPT scheme (B) Microfluidic channels filled with EGaIn liquid metal
for flexible NRIC WPT scheme (C). Circular wirewound Cu-coils.
Generally, rounded coils and edges are implemented to mitigate tissue damage caused
by the physical stress as in Figure 4.1 (C). Reducing the implant volume by optimizing the
design also mitigates physical damages caused by the implant. The antennas and coils used for
wireless in neural implants are encapsulated in semi-flexible silicone packages refer Figure 4.1
(A), (B) and (C)). Conformity and flexibility of the implant device are highly desirable as it
eases the placement of the IMD inside the body and reduces the physical stress, due to the
constant motion of the patient. However, this is limited by the complexities that arise due to
the needed flexibility in mobile implant applications. Additional analysis needs to be
performed to account for the changes after flexion so that the device functions well in the
strained tissue environment post-implantation.
4.5 Electromagnetic interference safety

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Airport security systems and court houses have metal detectors (walk-through
archways and hand-held wands) or full body imaging millimeter wave scanners that generate
strong EM fields which might interfere and alter the normal functionality of the IMD inside
the patient’s body. MRI machines use high-strength magnetic and electric fields to evaluate
tissue structures, heterogeneity, and motion; which might lead to catastrophic complications if
the IMD’s behaviour is affected. With added wireless systems for power and telemetry, the
EM interference from an external source can also add risk if hazardous, if the IMD design is
not conceived and implemented properly. Current FDA approved implants consider such
interference scenarios, and also do the risk analysis and issue warnings with the device.
4.6 Conclusion
This chapter ends with a brief explanation about various safety measures to be used to implant
bioelectronics.

CHAPTER 5
CONCLUSION
5.1 Introduction
In this chapter we will discuss about conclusion for the thesis of all chapters that are
discussed and future scope.
5.2 Conclusion
This report reviews various wireless power transfer platforms for neural implants
previously reported or under active development. The article summarizes the theory, link
design and challenges of different wireless strategies ranging from the near-field inductive and

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capacitive coupling and ultrasonic energy transfer. The NRIC scheme has been thoroughly
investigated for wireless power delivery and is deployed in current day FDA approved cochlear
and retinal implants. Flexible and conformal EM interfaces using this scheme, which would
enable conformably attaching them to the curvilinear body organs, are still under development.
The NCC scheme also comprises of flexible patches, but the PTE drops drastically with TX-
RX separation and is thus limited to be used in subcutaneous applications. Ultrasonic energy
transfer uses ultrasound waves to propagate the energy wirelessly through a medium, but is
limited by the large swings in PTE and the long-term effects of tissue vibrations have not yet
been investigated to demonstrate its safe usability for in-vivo applications. Mid-field and far-
field resonant schemes can wirelessly transfer the power to large tissue depths such as few
centimeters and can be used to power deep-seated implants, but low PTE for these powering
schemes limits its usage to ultra-low-power electronics for applications requiring few
milliwatts of power. For the devices consuming large amounts of power, the EM NRIC and
NCC schemes are still most suitable for meeting the power requirements. However, for low
power ranges of few milliwatt, ultrasonic, mid-field or far-field technologies can be safely
implemented. These emerging technologies promise specific advantages that can overcome the
shortcomings of the traditional schemes. Complete wirelessly powered cochlear and retinal
implants are already being used by thousands of patients worldwide, while cortical and
peripheral wireless implants are in the stages of pre-clinical and clinical research trials. Given
that the power requirements of all these neural implants are in the range of tens of milliwatts,
almost all of them use the NRIC scheme as of now. The IMD is either directly powered using
the NRIC coupled TX-RX coil pair or uses a rechargeable battery that is wirelessly charged on
a regular recharge-use cycle. Patient safety concerns and regulations originating from these
wireless IMDs have also been discussed in this article. The device design principles incorporate
these electrical, biological, physical and EM interference safety concerns which are strictly
governed by the safety standards regulated by FDA, only after which the device is approved
for human usage post successful pre-clinical and clinical trials. With increasing use of wireless
powering technologies in IMDs, safe and effective use, standardization and regulatory approval
should follow for an eventual more widespread use.
5.3 Future scope
With the advancement in semiconductor technology, electronic devices (integrated
circuit amplifiers, stimulators, very large scale integrated (VLSI) circuit implementations, etc.)

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have miniaturized to mm-scale, enabling us to directly implant them onto the individual nerves
as in Figure 5.1 and target nerve fibers with high spatial resolution. Ongoing progression in
soft, biocompatible and novel nanomaterial electrode interfaces has led to the capability of
conformably attaching them to the neural tissues and recording high SNR electrical activity.

Figure 5.1. Proposed mm-scaled neural dust implant wirelessly powered using ultrasonic
energy transfer scheme. (A) A neural dust mote attached on the sciatic nerve of a rodent model
(Inset shows optional testing leads). (B) The device assembled on a flexible PCB consists of a
piezoelectric crystal, transistor, and a pair of recording electrode pads.
With the advent of soft, flexible and stretchable biocompatible materials, it is now
feasible to conformably attach the EM interfaces directly on the objects for sensing
applications. Emerging wireless power transfer technologies like mid-field and ultrasonics
have made it possible to wirelessly power and control ultra-low power miniature IMDs to
almost any location in the human viscera. At the same time, the existing wireless schemes like
NRIC, where major design challenges have already been addressed by the scientific research
in the last decade, today’s developments are focused on link optimization for mm-sized devices
and improving the ease of usage in applications with flexible and conformal WPT interfaces.
Hybrid WPT systems using cascaded inductive-ultrasonic links are overcoming the
shortcomings of a specific wireless technology, thus enabling efficient long-range WPT inside
the multi-medium human body. Closed-loop wireless control of the implanted device permits
users to monitor and wirelessly control the functionality of the device from an external unit
post-implantation surgery and is now being implemented in commercial neurotech devices.

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All such technological developments will enable us to address diseases that have been
untreatable so far, or will at the very least enhance our capabilities to deal with the existing
solutions, with much higher precision. The potential of wirelessly delivering power to modulate
the electrical impulses by these gen next miniature neuro technology devices for controlling
the biological processes and treating diseases will lead to an era of bioelectronic medicines,
aka electroceuticals. These bioelectronics will be flexible and compact enough to directly
attach to the nerve fibres and target specific group of neurons, thus restoring the healthy states
by their electrical activity.

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