Documentation

You might also like

Download as pdf or txt
Download as pdf or txt
You are on page 1of 25

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 the 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.

Dept of ECE,TKRCET 1
Wireless Power Transfer Strategies for Implantable Bioelectronics

Chapter 5:

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 a discussion about the aim of the seminar, motivation for work
and organization of report.

Dept of ECE,TKRCET 2
Wireless Power Transfer Strategies for Implantable Bioelectronics

CHAPTER 2
WIRELESS POWER TRANSFER STRATEGIES
2.1 Introduction
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

Dept of ECE,TKRCET 3
Wireless Power Transfer Strategies for Implantable Bioelectronics

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.

With rapid leaps in technology over the last few decades, a myriad 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 the
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

Dept of ECE,TKRCET 4
Wireless Power Transfer Strategies for Implantable Bioelectronics

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

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.

Dept of ECE,TKRCET 5
Wireless Power Transfer Strategies for Implantable Bioelectronics

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.

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.

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

Dept of ECE,TKRCET 6
Wireless Power Transfer Strategies for Implantable Bioelectronics

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.
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

Dept of ECE,TKRCET 7
Wireless Power Transfer Strategies for Implantable Bioelectronics

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.
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

Dept of ECE,TKRCET 8
Wireless Power Transfer Strategies for Implantable Bioelectronics

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
piezoelectric energy harvester implanted inside the body within the main radiation lobe of the
TX and converts the acoustic energy back into electrical energy​.

Figure 2.8. Schematic of the ultrasonic energy transfer method.


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.
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).

Dept of ECE,TKRCET 9
Wireless Power Transfer Strategies for Implantable Bioelectronics

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
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

Dept of ECE,TKRCET 10
Wireless Power Transfer Strategies for Implantable Bioelectronics

inductive coils are placed in the multi-tissue layer environment separated by a few
centimetres, the WPT occurs at a very low PTE at the frequencies typically less 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.

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:

Dept of ECE,TKRCET 11
Wireless Power Transfer Strategies for Implantable Bioelectronics

(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
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.

Dept of ECE,TKRCET 12
Wireless Power Transfer Strategies for Implantable Bioelectronics

CHAPTER 3
VARIOUS IMPLANTS BASED ON WIRELESS POWER
TRANSMISSION
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.

Dept of ECE,TKRCET 13
Wireless Power Transfer Strategies for Implantable Bioelectronics

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 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

Dept of ECE,TKRCET 14
Wireless Power Transfer Strategies for Implantable Bioelectronics

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.

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

Dept of ECE,TKRCET 15
Wireless Power Transfer Strategies for Implantable Bioelectronics

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.
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

Dept of ECE,TKRCET 16
Wireless Power Transfer Strategies for Implantable Bioelectronics

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 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

Dept of ECE,TKRCET 17
Wireless Power Transfer Strategies for Implantable Bioelectronics

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.
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.​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

Dept of ECE,TKRCET 18
Wireless Power Transfer Strategies for Implantable Bioelectronics

battery-powered AspireSR has been implanted in more than 80,000 patients for epileptic
seizures control and management.

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.

Dept of ECE,TKRCET 19
Wireless Power Transfer Strategies for Implantable Bioelectronics

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.

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,

Dept of ECE,TKRCET 20
Wireless Power Transfer Strategies for Implantable Bioelectronics

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


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

Dept of ECE,TKRCET 21
Wireless Power Transfer Strategies for Implantable Bioelectronics

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


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.

Dept of ECE,TKRCET 22
Wireless Power Transfer Strategies for Implantable 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 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

Dept of ECE,TKRCET 23
Wireless Power Transfer Strategies for Implantable Bioelectronics

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.) 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.

Dept of ECE,TKRCET 24
Wireless Power Transfer Strategies for Implantable Bioelectronics

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.
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.

Dept of ECE,TKRCET 25

You might also like