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Implantable Electronic
Medical Devices
 Implantable Electronic
Medical Devices

Dr Dennis Fitzpatrick PhD CEng BEng(Hons)

MIET MIEEE FHEA

AMSTERDAM • BOSTON • HEIDELBERG • LONDON

NEW YORK • OXFORD • PARIS • SAN DIEGO
SAN FRANCISCO • SINGAPORE • SYDNEY • TOKYO

Academic Press is an imprint of Elsevier

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Notices
Knowledge and best practice in this field are constantly changing. As new research and experience
broaden our understanding, changes in research methods, professional practices, or medical treatment
may become necessary.
Practitioners and researchers must always rely on their own experience and knowledge in evaluating
and using any information, methods, compounds, or experiments described herein. In using such information
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ISBN: 978-0-12-416556-4
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Preface
Implantable systems in the human body are now becoming more widely acceptable and
available since the development of pacemakers and other implantable electronic medical
devices (IEMDs) such as hearing aids and glucose sensors. With a greater life expectancy
and an increasing demand for medical healthcare, there is a greater demand on technology
and biomedical engineers to develop implantable systems for a wide variety of medical diag-
nostics, treatments and therapies. It is fortunate that technology has advanced to comple-
ment the realization of IEMDs in terms of miniaturization, complexity, biomaterials and
defined standards.
With the new IEMDs comes the introduction of new regulatory standards to bring together
national standards from different countries under one internationally agreed standard for the
safe design and implementation of IEMDs. Manufacturers will have to comply and show
compliance with the new regulatory standard by displaying the new certification marks.
This book collectively groups medical devices with similar functionality into separate chap-
ters. It is the intention of this book to provide a background on the application of medical
devices, an introduction to the latest techniques used and examples of existing medical
devices. Subsequently, the book can be used as a guide to the design of medical devices and
also as a reference for existing medical devices. The book is aimed at those involved in or
who have an interest in the research and design of IEMDs. The healthcare industry is vast
and includes electronic engineers, bioengineers, biomedical engineers, clinical engineers,
clinical scientists, medical practitioners, surgeons and students alike.
Every effort has been made to provide an accurate description of the IEMDs featured in
this book. Consequently, I am very grateful to the respective representatives from the med-
ical device manufacturers for their invaluable feedback in order to ensure an accurate
representation of their implantable devices. My thanks also go to Laurel Brumant for the
anatomical illustrations and to Dr. David Chappell from the University of West London
for proofreading and reviewing the chapters in the book. I also thank Barry Nevison for
his support on cochlear implants and Tina Lee for her information research. A big thank
you also goes to Cari, Fiona and Naomi at Elsevier for their perseverance in chasing up
device manufacturers.

DISCLAIMER
Although every effort has been made by the author to ensure an accurate description of the
implantable electronic devices featured in this book, the author cannot be held responsible
for any inaccurate representation of the featured IEMDs.

ix
 Chapter
1
Retinal Implants
1.1 INTRODUCTION

■ FIGURE 1.1 Structure of the eye.

Figure 1.1 shows the main anatomical features of the eye. In normal sight,
light enters the eye through the pupil and is focused onto the retina at the
back of the eye, stimulating photocells that translate the light into electrical
signals. These electrical signals travel down the optic nerve to the visual
centers in the brain where they are decoded and perceived as images.
Progressive diseases of the eye that result in partial or total loss of vision
include glaucoma, retinitis pigmentosa, and macular degeneration.
Glaucoma results from an increase in the internal pressure of the eye,
the effects of which are irreversible, eventually leading to loss of sight.
However, if detected early, the onset of the disease can be managed with
medical treatment or laser surgery. Measuring the intraocular pressure of
the eye can help in detecting the early stages of the disease (see Chapter 2).
Implantable Electronic Medical Devices. DOI: http://dx.doi.org/10.1016/B978-0-12-416556-4.00001-2
© 2015 Elsevier Ltd. All rights reserved. 1
2 CHAPTER 1 Retinal Implants

Retinitis pigmentosa is a genetic disorder resulting in the degeneration of

the photoreceptor cells in the retina, leading to partial or complete loss
of sight. Currently there is no cure, although gene therapy in which a virus
is used to deliver sight-restoring therapeutic genes to the photoreceptors at
the back of the eye may offer an alternative form of treatment in the future.
Age-related macular degeneration (AMD) is another disease of the retina,
but it only affects a small area of the retina known as the macula which
contains a small population of cone-type photoreceptor cells that are
more responsive to bright light levels required for reading and viewing
objects close up and in greater detail. The onset of AMD occurs in the
later stages of life and only leads to a partial degeneration of sight.
Retinal implants are used to help people with degenerative retinal dis-
eases such as retinitis pigmentosa and AMD where the optic nerve and
the visual centers in the brain are still functioning but the patient has lost
light or sight perception due to degeneration of the outer layer of the reti-
nal photoreceptor cells. However, the cells in the inner retinal layer are
relatively intact compared to the outer cells and it is the inner cells which
form a neuronal ganglion interface to the optical nerve. Retinal implants
will not benefit people who have been blind from birth because their
optical visual neuronal circuits and visual processing centers in the brain
have not been developed or conditioned to perceive vision.

1.2 THE RETINA

Light entering the eye through the lens is focused onto the retina which
consists of a thin layer of transparent neural tissue located at the back of
the eye. Near the center of the retina is a region known as the macula
which has a high concentration of neural cells responsible for seeing
detailed colors and represents the center of vision. At the center of the
macula is a small depression or dimple known as the fovea which repre-
sents the absolute center of vision and highest color resolution attainable,
providing the clearest and sharpest images. Subsequently, the eye contin-
uously moves (saccades) such that the lens focuses images of interest
onto the fovea for the highest image of color resolution.
The retina is made up of three main functional neural cell layers: photo-
receptor cells, bipolar cells, and ganglion cells. Interspersed between the
layers are the horizontal and amacrine neural cells as shown in
Figure 1.2. The photoreceptor cells at the back of the retina transduce
photon light energy into graded neural signals which are transmitted and
processed via the bipolar and ganglion cell layers. It is the axons of the
 1.3 Photoreceptor Cells 3

■ FIGURE 1.2 Structure of the retinal layers.

ganglion cells which together collectively form the optic nerve which
leads to the visual processing centers in the brain.

1.3 PHOTORECEPTOR CELLS

There are two types of photoreceptor cells: rods, which have the ability
to detect color but are sensitive to low light levels (scotopic vision), and
cones, which in bright light are sensitive to colors (photopic vision) in
the visible spectrum. The rods and cones are made up of four segments

■ FIGURE 1.3 Photoreceptor cone and rod cells.

4 CHAPTER 1 Retinal Implants

(Figure 1.3): the outer segment, inner segment, cell body (nucleus), and
synaptic terminals.
The outer segment in rods and cones consists of the outer membrane fold-
ing in on itself and stacking up to form disks. In the case of rods, the in-
folded membranes become detached and the disks float inside the outer
segment. Located on the disks are light-sensitive pigment proteins, rhodop-
sin in rods, and iodopsin in cones. The inner segment contains mitochon-
dria which provide the energy required for chemical reactions and the cell
body which contains the cell nucleus and other cell organelles essential to
maintain cell functionality. The synaptic terminals provide for the transmis-
sion of glutamate neurotransmitters between neural cell synaptic bodies.

■ FIGURE 1.4 Structure differences between rods and cones. (http://www.ic.ucsc.edu/Bbruceb/psyc123/

Vision123.html.pdf.)

In rods, the outer segment is cylindrical, whereas for cones, the outer seg-
ment is conical in shape (Figure 1.4). Typical outside diameters for the
inner and outer segments are 2 µm for rods and 6 µm for cones. The rods
also contain a greater number of light-sensitive disks in the outer segment
compared to cones, resulting in a greater sensitivity to light. There are
typically 120 million rods compared to 6 million cones in the retina.
In rods, all the disks contain the same light-sensitive pigment, rhodopsin,
which exhibits a peak absorption of light energy at a wavelength of
500 nm which lies within the blue-green region of the visual light spec-
trum. In cones, the light-sensitive iodopsin pigment occurs in three
 1.3 Photoreceptor Cells 5

varieties due to differences in their amino acid sequence, each with dif-
ferent peak absorption wavelengths in the red (560 nm), blue (420 nm),
and green (530 nm) regions of the visible light spectrum, respectively.

Blue Green Red

cones Rods cones cones
100
Retinal response (percent maximum)

75

50

25

0
380 450 500 550 600 650 700 750
Wavelength of light (nm)

■ FIGURE 1.5 Electromagnetic spectrum of the human eye.

Although each cone contains three different opsin pigment types, there are
three different types of defined cones: short-wave (blue light), medium-
wave (green light), and long-wave (red light), each with a predominant
opsin variety in the cone. The superimposition of the light absorption
response of each opsin pigment will result in a peak response around the
area of the defined cone color type. For example, the peak response of a
long-wave cone will be shifted due to the superimposition of the individ-
ual blue and green opsin spectrum absorption responses, toward the
yellow-green region of the visible spectrum as shown in Figure 1.5.
Figure 1.6 shows a rod photoreceptor cell with sodium- and potassium-
specific ion channels in the outer membrane. In the absence of light,
there will be a continuous flow of positively charged sodium ions into
the cell and potassium ions out of the cell, collectively known as the
“dark current.” This dynamic arrangement gives the photoreceptor cell a
resting potential of approximately 230 to 240 mV. Neurotransmitters
(glutamate) are also released from the synaptic terminals of the photore-
ceptor cell. When light photons strike the visual pigments in the disks, a
6 CHAPTER 1 Retinal Implants

■ FIGURE 1.6 Induced ionic currents in photoreceptor cell.

series of chemical reactions involving enzyme activity causes the cell to

hyperpolarize and reduce the release of synaptic neurotransmitters.

1.4 BIPOLAR AND GANGLION CELLS

As shown in Figure 1.2, the bipolar and ganglion cell layers are inter-
laced with two other cell types, the horizontal and amacrine cells.
The neural signals from the photoreceptor cells interface with the bipolar
cells directly or indirectly via the horizontal cells, which in turn interface
with other bipolar cells or other adjacent horizontal cells. Similarly, the
bipolar cells interface with the ganglion cells directly or indirectly via
the amacrine cells, which in turn interface with other ganglion cells and
other adjacent amacrine cells.
There are two types of bipolar cells, both of which receive the glutamate
neurotransmitter, but the ON-center bipolar cells will depolarize, whereas
the OFF-center bipolar cells will hyperpolarize. This arrangement helps
provide a spatial processing of the visual input derived from the photore-
ceptor cells. The bipolar cells provide one of many sensory inputs to the
ganglion cells which are thought to be involved with temporal aspects of
color vision being sensitive to speed of movement. The output synapses
of the ganglion cells form the optic nerve which transmits the neural
image data to the visual cortex in the brain for decoding into perceived
images. The ganglion cells also contain the photopigment melanopsin
which is involved in the pupillary light reflex mechanism where the pupil
constricts when the retina is exposed to bright light.
 1.5 Retinal Implants 7

1.5 RETINAL IMPLANTS

In retinal diseases such as retinitis pigmentosa and AMD where the
photoreceptors are damaged, the inner bipolar and ganglion layers are
relatively intact and still functioning. Consequently, in order to restore
some form of light perception and ultimately vision perception, a retinal
implant would need to focus on replicating the sensation of light and
darkness by artificially hyperpolarizing and depolarizing remaining pho-
toreceptor and subsequent bipolar cells in a damaged retina.
The technique used by many retinal implantable devices is to stimulate
the inner nerve cells of the retina electrically with an ordered pattern of
electrical impulses using arrays of electrodes implanted into the retina.
The electrical stimuli can then be derived from extracted video data from
an external video camera attached to a pair of glasses. Alternatively,
microphotodiodes can be used to convert the incident light energy of
images on the retina, as the lens of the eye is still functional, into electri-
cal stimuli. The array of microphotodiodes and microelectrodes are sym-
metrically aligned such that they effectively bypass the outer damaged
photoreceptor cells, stimulating the inner nerve cells directly. Retinal
prostheses can also provide conditioned electrical impulses to evoke pat-
terns of light dots to represent Braille characters.
Retinal implants can be epiretinal where the implant is inserted on the
surface of the retina with electrodes extending into the internal layers of
the retina to stimulate either the bipolar or ganglion cells; subretinal
where the implant is inserted inside the retina in the photoreceptor layer;
or suprachoroidal where implants are implanted in the suprachoroidal
space at the back of the eye between the retina and the sclera of the eye.
Other considerations for retinal implants, apart from suitable biocompati-
ble materials, include the mechanism by which the implant is “fixed” in
place as well as the technique on how to supply power to the electronic
devices in the implant. Typical techniques used include inductively cou-
pled magnetic field coils to transfer energy from an external source to an
implanted receiver coil, energy harvesting from the incident light falling
on the retina, or using an external infrared laser beam mounted on a pair
of glasses to power the implant.
One measure of achieved visual resolution of retinal implants is the
visual acuity achieved. Visual acuity refers to the contrast and resolution
detail in which an image in the center of vision can be seen. Other terms
used include the sharpness, clearness, or acuteness of a perceived image.
Visual acuity is measured relative to normal vision, which is defined as
8 CHAPTER 1 Retinal Implants

20/20 and refers to the ability of the human eye to distinguish between
separate arc lines drawn on a chart, 20 ft (6 m) away. Each arc line is
separated by 1 min (sixtieth) of a degree (equivalent to a separation of
1.75 mm). In comparison, the detail that a person with 20/40 vision can
read at a distance of 20 ft, can clearly be read by a person with 20/20
vision at a distance of 40 ft.

1.6 MICROELECTRODES
Cell membrane potentials can be altered by injecting small bidirectional
currents into the subretinal layer to induce the sensation of light, the image
resolution being dependent on the population of bipolar cells that can be
activated. The delivery of these currents to a small number of cells would
necessitate using micro- or nanofabrication of needle-type electrodes in
order to provide adequate “pixel” resolution (retinoscopy) and sensitivity to
restore some form of visual perception. However, the amount of bidirec-
tional current that can be safely delivered is dependent on the charge
“capacity” and material of the electrode. Charge capacity is defined as
the maximum amount of charge per unit area that can be delivered by
a biphasic current pulse to an electrode without sustaining substantial
electrode damage. The smaller the electrode, the lesser its charge capacity.
The actual electrode charge capacity is dependent on the applied electrode
potential. The charge density at the interface of the electrode and surround-
ing tissue, the electrolyte, is defined as the injected charge per phase of a
biphasic stimulation pulse, per unit surface area of the electrode.
As the electric charge delivered is proportional to the electrode surface
area, there is a trade-off between the electrode size, to activate a suffi-
cient number of neural cells for sufficient image resolution and the
amount of charge that can be delivered without incurring electrode or
surrounding tissue damage. Increasing the electrode potential can lead to
the electrolysis of water in which the reduction of water, for a negative
going current pulse, produces hydrogen gas, whereas a positive going
current pulse results in the oxidation of water, producing oxygen gas.
The production of oxygen and hydrogen gases, also known as “bub-
bling,” is irreversible. A range of electrode potentials known as the
“water window” defines the limits between which no gases are produced.
The reversible charge injection can be defined as the maximum charge
density applied without the electrode exceeding the water window during
pulsing (Roblee and Rose, 1990). This therefore defines the charge injec-
tion capacity limit of an electrode. Other irreversible reactions include
metal corrosion where an electrode is driven to a positive potential which
 1.7 Microphotodiodes 9

Table 1.1 Electrode Potential and Electrochemical Charge Limits for

TiN and IrOx
Electrode Potential Electrochemical Charge
Limits Limits (mC/cm2)

TiN 20.75 to 21.25 V 0.6 0.9

IrOx 20.6 V to 08 V 1 3

causes the metal to oxidize, resulting in the production of toxic reactants.

The requirement then is to make electrode arrays smaller but still retain a
high charge density.
The microelectrode arrays for retinal implants most commonly use a
metal oxide coating of either titanium nitride (TiN) or iridium oxide
(IrOx) resulting in a higher electrode charge capacity density compared to
other noble metal electrodes such as platinum and iridium. The coatings
act as a dielectric, forming a double-layer capacitor interface between the
electrode and the surrounding tissue that forms the electrolyte. A negative
going cathodic pulse on the electrode will induce a positive ionic current
in the electrolyte toward the electrode eliciting a neural cell membrane
depolarization. The subsequent positive going anodic pulse will reverse
the ionic current flow, resulting in a net zero injection of charge.
Table 1.1 provides the electrochemical limits for TiN and IrOx.

1.7 MICROPHOTODIODES
Microphotodiodes consist of an array of individual photodiodes and stim-
ulation electrodes such that they effectively transduce incident light
energy into an electric stimulus, thus replicating the function of photore-
ceptors. Each microphotodiode has an electrode array configuration such
that a pixelated image effectively will be mapped to stimulate the appro-
priate bipolar cells approaching that of the natural retinotopy of the
received retinal image. The larger the array of photodiodes and electro-
des, the greater the pixel (spatial) resolution and the subsequent retinoto-
py of the retinal implant. The photodiodes generate currents which are
typically converted into a voltage. The resultant monophasic voltage
pulses are applied to capacitively coupled electrodes in order to provide a
biphasic charge-balanced stimulus pulse, minimizing the possible risk of
cell damage which would normally result from a nonzero polarization of
the electrode.
10 CHAPTER 1 Retinal Implants

1.8 ARGUS II RETINAL PROSTHESIS (SECOND SIGHT

MEDICAL PRODUCTS)
The Argus II Retinal Prosthesis from Second Sight Medical Products has
been designed to help patients with loss of sight mainly due to degenera-
tive retinal diseases such as retinitis pigmentosa where there is a degener-
ation of the retinal outer layer of light-sensitive photoreceptors such that
the patient has bare light or no light perception.

■ FIGURE 1.7 The Argus II Retinal Prosthesis System from Second Sight. (Copyright ª 2013 Second
Sight Medical Products, Inc. Reprinted with permission.)

The Argus II System consists of a pair of glasses which incorporates an

internal video camera which captures a scene (Figure 1.7). The video
data for the scene is sent by a cable to the video processing unit which is
an external device normally worn on a belt and contains the battery
power supply. The processed video data is then sent back to the glasses
where it is transmitted wirelessly to a receiver implanted on the outer sur-
face of the eyeball. The receiver then sends electrical pulses via a thin
flat wire, through a small incision in the eye, to an electrode array which
is implanted in the eye (Figure 1.8).

Scleral band

Electrode
Electronics array
case

Receiver
coil

■ FIGURE 1.8 The Argus II Retinal Prosthesis from Second Sight Medical Products. (Copyright ª 2013
Second Sight Medical Products, Inc. Adapted and printed with permission.)
 1.8 Argus II Retinal Prosthesis (Second Sight Medical Products) 11

The electrode array consists of 60 electrodes on a substrate measuring

1 mm 3 1 mm which is placed at the back of the eye over the retina and
secured in place by a surgical tack centered on the macula region (Figure 1.9).

■ FIGURE 1.9 Electrode array secured in place over the retina. (Copyright ª 2013 Second Sight Medical
Products, Inc. Reprinted with permission.)

The electrodes make contact with the inner nerve retinal ganglion layer in
the retina thus bypassing the outer damaged photoreceptors. With retinitis
pigmentosa, the inner nerve retinal ganglion cells are still functional and
still retain a viable connection to the optic nerve such that electrical pulses
applied to the electrode array will stimulate nerve fibers in the optic nerve.
Figure 1.10 shows the components of the retinal prosthesis. The scleral
band wraps around the eye and goes underneath the eye muscles

■ FIGURE 1.10 Components of the Argus II which sit in the eye socket. (Copyright ª 2013 Second
Sight Medical Products, Inc. Reprinted with permission.)
12 CHAPTER 1 Retinal Implants

and is held in place by sutures on the band. Embedded in the strap is the
coil which receives external data and supplies power to the receiver. The
whole assembly sits within the eye socket hidden from view (Figure 1.11).

■ FIGURE 1.11 Assembled Argus II which sits in the eye socket. (Copyright ª 2013 Second Sight
Medical Products, Inc. Argus II Retinal. Reprinted with permission.)

The Argus II has approved regulatory CE mark from Europe and FDA
approval. Patients using the Argus II have reported being able to make
out shapes, movement, distinguish between light and dark, and read large
letters. The next generation of Second Sight implants, Argus III and IV,
will incorporate a 256-grid electrode array.

1.9 ARTIFICIAL SILICON RETINA IMPLANT,

OPTOBIONICS
The Artificial Silicon Retina (ASR) from Optobionics is a self-contained,
self-powered retinal implant designed to convert light energy from
images into electrical impulses, stimulating the nerve cells within the ret-
ina. The ASR is a microchip with approximately 5000 independently
functioning microelectrode-tipped microphotodiodes. Incident light
energy is also used to power the microchip. Consequently, there are no
external power supplies, leads, or external camera to capture the images.
The ASR measures 2 mm in diameter with a thickness of 25 µm and is
implanted under the retina in the subretinal space (Figure 1.12).
Figure 1.13 shows the fabricated microphotodiode pixels, each measuring
20 µm 3 20 µm with a 9 µm 3 9 µm iridium oxide electrode deposited
and electrically bonded to each pixel. The separation between pixels is
5 µm 3 5 µm. With a light illumination of 800 foot-candles, the pixel cur-
rent is between 8 and 12 nA.
 1.10 Alpha-IMS Implant by Retina Implant AG 13

Inner retina

Outer retina

Optic nerve

Lens

Iris
Implant in Cornea
the subretinal space

■ FIGURE 1.12 ASR in situ. (Copyright ª Optobionics. Reprinted with permission.)

■ FIGURE 1.13 ASR microphotodiode pixel (Chow et al., 2004). (Reprinted with permission.)

1.10 ALPHA-IMS IMPLANT BY RETINA IMPLANT AG

The Alpha-IMS is a subretinal prosthesis that converts light energy from reti-
nal images into electrical signals to effectively bypass damaged photorecep-
tor cells and stimulate still active bipolar neural cells. The implant is placed
beneath the fovea in the outer retina and is powered from an external power
source providing inductively coupled energy (and control signals) to a
receiver coil implanted under the skin behind the ear. The external
14 CHAPTER 1 Retinal Implants

Energy supply
Pigment epithelium
Photoreceptors
Sclera Bipolar cells
Choroid Ganglion cells
Retina Nerve cells

Stimulation
electrodes
Subretinal
t implant
Ligh
where photo
receptors are
degenerated
Stimulation chip

(B)

(A) copyright by retina implant

■ FIGURE 1.14 (A) Alpha-IMS subretinal prostheses. (B) Implant inserted in the subretinal space toward the outer retina. (Copyright ª Retina Implant AG.
Reprinted with permission.)

transmitter coil is held in place by magnets inserted into the skull. A silicone
cable from the receiver coil runs subdermally to the eye socket where it con-
nects to a thin polyimide foil cable which enters the subretinal space through
a small incision in the sclera and choroid at the back of the eye (Figure 1.14).
A reference electrode is placed subdermally in the orbit rim of the eye.
Figure 1.15A shows the implant which consists of a microchip placed on
a flexible polyimide printed circuit board. The microchip contains an
array of 1500 photodiodes and 1500 electrodes arranged as individual
elements as shown in Figure 1.15B. Each element contains a rectangular
15 µm 3 30 µm microphotodiode, a 50 µm 3 50 µm TiN electrode array,
and a differential amplifier, each element measures 72 µm 3 72 µm.
The electrodes are 70 µm long with a diameter of 70 µm and are spaced
70 µm apart. The implant also contains an array of 4 3 4 test electrodes for
direct stimulation of bipolar cells. The test electrodes are light independent
and provide a means to assess electrode interface characteristics and current
pulse stimulation patterns. The microchip measures 3 mm 3 3 mm with a
thickness of 70 µm and is fabricated using 0.8 µm CMOS technology.
The biphasic stimulation current delivered by the electrodes is dependent on
the amount of light striking the microphotodiodes and typically delivers
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Meißel posuistis

Eleorum Amphicleenses Athenas

putabant
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