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Injectable Electronic Identification, Monitoring, and Stimulation Systems


Annual Review of Biomedical Engineering
Vol. 1:177-209 (Volume publication date August 1999)
https://doi.org/10.1146/annurev.bioeng.1.1.177 (https://doi.org/10.1146/annurev.bioeng.1.1.177)

Philip R. Troyk 1
1Department of Electrical and Computer Engineering and the Pritzker Institute of Medical Engineering, Illinois Institute of

Technology, Chicago, Illinois 60616; email: troyk@charlie.cns.iit.edu (mailto:troyk@charlie.cns.iit.edu)

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Sections
ABSTRACT | KEY WORDS  | INTRODUCTION | CONCEPT OF INJECTABLE MICROMODULES |
HISTORICAL EVOLUTION OF MICROMODULES | TECHNOLOGICAL CHALLENGES TO MICROMODULE DESIGN |
FEATURES OF SPECIFIC RADIO FREQUENCY IDENTIFICATION AND MICROSTIMULATOR SYSTEMS |
TESTING OF INJECTABLE MICROMODULE SYSTEMS | CONCLUSIONS |

Abstract

▪ Abstract  Historically, electronic devices such as pacemakers and neuromuscular stimulators have been
surgically implanted into animals and humans. A new class of implants made possible by advances in
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monolithic Policy design and implant packaging is small enough to be implanted by percutaneous
injection through large-gauge hypodermic needles and does not require surgical implantation. Among these,
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commercially available implants, known as radio frequency identification (RFID) tags, are used
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pet, laboratory animal, and endangered-species identification. The RFID tag is a subminiature glass capsule
containing a solenoidal coil and an integrated circuit. Acting as the implanted half of a transcutaneous
magnetic link, the RFID tag is powered by and communicates with an extracorporeal magnetic reader. The tag

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transmits a unique identification code that serves the function of identifying the animal. Millions of RFID tags
have been sold since the early 1980s. Based on the success of the RFID tags, research laboratories have
developed injectable medical implants, known as micromodules. One type of micromodule, the
microstimulator, is designed for use in functional-neuromuscular stimulation. Each microstimulator is uniquely
addressable and could comprise one channel of a multichannel functional-neuromuscular stimulation system.
Using bidirectional telemetry and commands, from a single extracorporeal transmitter, as many as 256
microstimulators could form the hardware basis for a complex functional-neuromuscular stimulation
feedback-control system. Uses include stimulation of paralyzed muscle, therapeutic functional-neuromuscular
stimulation, and neuromodulatory functions such as laryngeal stimulation and sleep apnea.

Key Words 

microstimulator (/keyword/Microstimulator) ; RFID (/keyword/RFID) ; transcutaneous coupling (/keyword


/Transcutaneous+Coupling) ; micromodules (/keyword/Micromodules) .

Introduction

Electronic devices implanted within animals and humans have seen a long history. Pacemakers are perhaps the
best known and most successful examples of electronic medical implants. A pacemaker uses a titanium case
for hermetic sealing of integrated digital/analog circuitry and an internal battery. The electrical
interconnections through the hermetic titanium enclosure are typically accomplished by using glass-on-metal
feedthroughs. This interconnection method has been successful, for pacemakers, because the number of
independent input-output connections is small, o�en four or less. Powering of the pacemaker by an internal
battery is feasible because the power demands of the pacemaker are relatively low.

In other medical implants, the pacemaker approach has been used with limited success. Implants for
functional-neuromuscular stimulation (FNS), or chronic-pain–masking applications, o�en require power
sources that exceed the capacity of pacemaker-style batteries. Therefore, most of these implants are powered
by transcutaneous magnetic coupling, and, owing to eddy-current losses, the use of a metal hermetic
enclosure is precluded. Some FNS researchers anticipate the need for over 100 channels of electrical
stimulation and the requisite high number of lead wires and feedthroughs, if using a pacemaker-style
enclosure, is impractical. The clinical implementation of electrical stimulation as a therapeutic intervention for
neuromuscular dysfunction has, to a large degree, been limited by cost and availability of implantable
stimulation hardware. O�en clinicians attempt to adapt a device designed specifically for one application to
another. During the past 10 years, an alternative approach has emerged. Based on commercially available
devices, known as radio frequency identification (RFID) tags, a new class of injectable implant, the
micromodule, has been developed. One type, the microstimulator, is a grain-of-rice–sized, hermetically sealed,
leadless electronic device that is small enough to be percutaneously implanted into the body, via a 10- or 12-
gauge hypodermic needle. Each microstimulator can serve as a single channel of a multichannel FNS system.

During the last 15 years, electronic and implant-packaging research has made theCookie development
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of a variety of
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injectable Policy electronic implants possible. Many of these implants perform the simple function of
electronic identification for the tagging of livestock, migratory animals, pets, laboratory animals, and
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endangered species. Others, currently in development, will be capable of more complex Acceptfunctions
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functional electrical stimulation, bioelectric sensing, goniometric sensing, and temperature sensing. The
significance of these micromodules stems from their generic nature. Because each device is physically and
electrically distinct, many devices can be combined in a building-block manner to construct larger, more 
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complex systems, and failure of a single implant a�ects only a single stimulation channel. This review presents
the concept of an injectable micromodule implant, examines the historical evolution of RFID tags and
microstimulator projects funded by the National Institutes of Health, describes the technological challenges of
designing micromodules, presents characteristics of specific RFID and microstimulator systems, explores the
status of in-vivo testing, and suggests possible future applications.

Concept of Injectable Micromodules

The typical diameter of an injectable micromodule is 2–3 mm, and its length is 1–1.5 cm. The shape is usually
cylindrical to facilitate passage through a hypodermic needle. It is this small size that poses the technological
challenges to design. Internally, the micromodule contains a microcoil and integrated electronics; the number
of internal components is kept to a minimum. For some devices, all of the internal electronic components,
including the charge storage capacitor, are integrated on a single monolithic chip. A photograph of a
commercially available RFID tag can be seen in Figure 1 . Contained within the hermetic glass capsule in
Figure 1 is a ferrite-core solenoidal coil connected to the pads of an integrated circuit. There are no other
internal components.

Figure 1  Commercial injectable radio frequency identification (RFID) transponder. Within the glass
capsule is a microcoil connected to an integrated circuit. (Photograph courtesy of Trovan® LTD.)

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Without regard to its function, an injectable micromodule functions by receiving power and communications
through a transcutaneous inductive link. A transmitter coil placed on the skin andCookie over the region of the
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implant creates an intense alternating magnetic power field. The micromodule contains a microcoil that forms
one-half of astores
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data such The current
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the same inductive link, commands to the micromodule from the transmitter (forward telemetry) can be
accomplished by either modulating the power field or superimposing another command data carrier on the
transmitter coil. Telemetry from the micromodule to the transmitter (reverse telemetry) is accomplished either

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by using the power field as a clock and modulating a data subcarrier or by asynchronously modulating a
separate data carrier.

Fundamentally, transcutaneous links for micromodules are identical to links used in all transcutaneously
powered implants. Modeling of transcutaneous links has been presented by numerous researchers ( 12 , 18 , 19 ,
23 , 26 , 42 , 46 ). In most cases, optimizing the link is accomplished by manipulating the linkʼs physical size, self-
resonant-frequency tuning, quality factor (Q), or coupling coe�icient (k). By virtue of their small size, the
magnetic coupling between the implanted micromodule and the extracorporeal transmitter is extremely low.
Heetderks ( 23 ) presented a link analysis specific to subminiature coils for micromodules. For micromodules,
strategies o�en used for larger links ( 12 , 18 , 42 ) that improve the coupling or desensitize the coupling to
geometric changes are largely ine�ective. Troyk & Schwan ( 46 , 52 ) showed that the only practical solution to
powering micromodules is to generate an unusually intense magnetic field at radio frequencies 100 kHz–10
MHz. For a transmitter coil several centimeters in diameter, the required peak current can be several amperes.

Because they are small and the coupling coe�icient to the transmitter coil is low, there is little penalty for
placing many micromodules within a single-transmitter field. Therein lies the attraction for their use in FNS
systems; a large number of devices can be powered and commanded over a single link with little to no increase
in transmitter power. Because they are leadless, the problem of lead-wire tethering is eliminated, and the
integrated nature of the electronics reduces the manufacturing costs.

Functionally, micromodules vary, depending on the intended application. For RFID tags, usually, each research
animal contains only one micromodule. The function of the RFID tag is to use reverse telemetry to transmit a
unique digital identification number stored within the integrated circuit chip. Once the strength of the
transcutaneous magnetic field produced by the extracorporeal transmitter is su�icient to power the
micromodule, a digital clock signal is recovered from the transmitterʼs power carrier. The recovered clock is
divided down to generate a data subcarrier. Frequency shi� keying, phase shi� keying, or amplitude
modulation is used to modulate the data subcarrier with the contents of the micromoduleʼs integrated-circuit
memory. Within the transmitter, receiver circuitry detects the weak data subcarrier and processes the digital
information in a microprocessor, recovering the identification code. For RFID tags, performance is o�en
measured by the maximum distance away from the transmitter for which the micromodule will function
(reading distance).

In contrast, microstimulators function by receiving power and commands (forward telemetry) from the
transmitter coil. Metal electrodes protrude from each end of the device and act as stimulation electrodes for
nearby nerves, or muscle motor points. One type of microstimulator similar in form to RFID tags is shown in
Figure 2 . Each microstimulator has its own digital address, that the external transmitter uses to control
individually its stimulation parameters. Pulse amplitude, pulse width, and electrode recharge current can be
specified for each microstimulator contained within the transmitterʼs field, by sending digital commands over
the transcutaneous link.

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Conceptually, for patients, microstimulators might be used in an FNS system as depicted in Figure 3 . A helical
transmitter coil is shown wound around the forearm of the patient. The microstimulators are shown placed
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longitudinally within theand
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analytics.arm muscles.
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transmitter coil and modulates it in accordance with commands from the controller. As many microstimulators
as required, one for each of the desired number of stimulation channels, would be injected into the forearm.
The single external helical transmitter coil would control all of the implanted microstimulators. 
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Figure 2  Microstimulator. At each end, a stimulating metal electrode exits the glass capsule. (Photograph
courtesy of A. E. Mann Foundation.)

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Figure 3  Injectable microstimulator for stimulation of paralyzed muscle. The single helical transmitter
coil can power and command many individual microstimulators within the limb.

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The microstimulator contrasts with other multimodule implanted FNS stimulation systems ( 24 ). In earlier
systems, di�erentiation between di�erent implants was accomplished by setting each implant for a di�erent
tuned inductive-link frequency. This approach would not be viable for the injectable microstimulator because
of the resulting ine�iciency in power transmission for a group of stimulators, each tuned to a di�erent
frequency. In addition, it would not be practical to select up to 256 di�erent frequencies, and each implant
would have a link bandwidth that would be too low for rapid communication and microstimulator commands.
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Historical Evolution Of Micromodules
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The first injectable micromodules were RFID tags. However, earlier RFID tags that were not small enough to be
injectable provided the functional basis for design of the injectable tags. In 1972, Kriofsky & Kaplan ( 25 ) filed 
a
patent application for an “inductively coupled transmitter-responder arrangement.” They described a device
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that included many of the key elements of electronic tags. This device was inductively coupled and completely
passive; no internal battery was used. The system used separate power and data coils within the transponder
and within the transmitter. At that time, technology did not permit the level of electronic integration necessary
to reduce the size of the device, and, in this patent, no mention is made of packaging or implantation. The
reverse telemetry was limited to coded information in the form of a digital counter preset. However, the system
described in the patent remains a significant achievement.

In 1979, Beigel ( 2 ) filed a patent application for an “Identification Device.” His work is an important landmark in
RFID, because his design emphasized small size. He combined Kriofskyʼs separate power- and data-inductive
links into one common inductive link. Furthermore, Biegel intended the device to be used for implantation into
an animal for the purposes of identification. The identification code was not stored in a true memory but rather
used preset connections on an o�-the-shelf digital counter. Although the miniaturization was limited by the use
of discrete analog and digital hybrid circuitry, other researchers were working on miniaturized devices.

In 1985, Milheiser ( 30 ) filed a patent for an “Identification System” in which he described an RFID tag that
formed the basis for many subsequent designs. All of the RFID tagʼs internal circuitry, memory included, is
presented as being integrated in a single monolithic chip, with the exception of the rectification circuitry and
the charge storage capacitor. Although Milheiser does not mention packaging, the assignee, Identification
Devices, was, at that time, engaged in a development e�ort for an injectable micromodule RFID tag. A major
obstacle was the packaging of the electronics to make it resistant to the deleterious e�ect of the implanted
environment.

In 1986, Carroll ( 7 ) filed a patent application for a “Transponder Device,” and, in 1988 ( 8 ), he filed another
application for a “Single Chip Transponder Device.” Both of these patents describe an RFID transponder with all
components integrated on a single silicon chip, including the rectifier, charge storage capacitor, and microcoil.
Although the thin-film technology for full realization of this design was, in 1988, not yet completely available,
the vision for future devices was established. At the present time, single-chip RIFD devices are not available,
although work on electroplated photolithographic coils is in process ( 55 ).

For most of the previously described devices, packaging remained a significant obstacle to the design of an
injectable device. In 1986, V Taylor, D Koturov, J Bradin, and GE Loeb filed the first of a series of patent
applications for a “Syringe-Implantable Identification Transponder.” Although abandoned three times, the
inventors persisted and, in 1991, filed a final application, leading to the issuing of a 1993 patent ( 44 ). Initially,
the motivating application for this device was identification of horses. The device presented in this patent
specifically addresses the issue of packaging, and a complete injectable system is described. The patent
presents a monolithic integrated circuit that contains all of the tag electronics, except for the microcoil. The
microcoil is described as wound around a solenoidal ferrite form.

Figure 4 shows the Taylor system as depicted in the patent. In the lower half of the figure, the transponder is
seen in cross section. In the upper half, the syringe injector is shown. Note that the size of the transponder in
the lower half of Figure 4 is not to scale with the injector in the upper half. Within the barrel of the injector,
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partially in cross section. The wires, 56, from the coil connect to the integrated circuit, 54. Physically, the Taylor
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<2.5 mm in diameter and <1.3 cm long. A key element of this patent is the use of a glass capsule to protect the
implant electronics and microcoil from corrosion. The assignees, Deston/IDI (formerly Identification Devices
Inc.) and Hughes Aircra�, placed the Taylor RFID tag into commercial production. One of the prominent 
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applications for the Taylor transponder was the identification of fish passing through dams on the Colorado
River. The commercial production of this tag was a significant milestone in the development of injectable
micromodules. It established the feasibility of implanting an untethered miniature electronic device by means
of percutaneous injection.

Figure 4  Detail from a 1993 patent by Taylor et al. (Top) A needle injector with an RFID tag (32) in the
barrel of the needle (30) for injection into the animal (F). (Bottom) Enlarged drawing of the tag showing
the internal components.

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By 1989, other commercial e�orts to develop RFID transponders were in process. The target market was
identification of livestock. Worldwide, cattle and food regulatory agencies determined that it was desirable to
track individual animals from birth through slaughter. Large numbers of transponders were required to meet
the needs of this market, by some estimates as high as 20 million devices per month, and large-scale
manufacturing methods were needed to meet this demand. The Destron/IDI transponder, described above,
operated with a transmitter frequency of 400 kHz, and manufacture, to a large degree, involved manual
manipulation of the assemblies under a microscope. In addition, the reading distance of the Taylor
transponder, ∼5 cm, was judged by some to be inadequate for automatic identification Cookie of large numbers of
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livestock animals. Regulatory issues in Europe made it attractive to design new systems for operation at
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One of these was initiated, in 1989, by Trovan® LTD. The design criteria for the Trovan system was to increase
the state-of-the-art reading distance from 5 cm to at least 16 cm and to increase the speed of the reverse 
telemetry so that the livestock could be automatically identified in the shortest possible time. A rapid
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engineering e�ort led to the design of a line of transponder devices and a number of patents ( 10 , 21 , 22 , 47 – 49
, 62 ). DeMichele ( 10 ) developed a new microtransformer to replace the simple microcoil and to permit
operation at the lower frequency of 125 kHz without the addition of a resonating capacitor. Troyk and
DeMichele ( 49 ) defined a new data protocol and data subcarrier to increase the reverse telemetry speed by a
factor of 5. Methods of magnetic design, within the transmitter, for detecting the weak reverse telemetry
system, in the presence of the strong transmitter signal and other electrical noise were established ( 47 ). The
Trovan system remains, to this day, a system noted for high performance.

In 1990, Urbas and Ellwood ( 54 ) filed a patent application for an RFID transponder that included a temperature
sensor for reverse telemetry of the body temperature of the implanted animal. Designed primarily for the
identification of laboratory animals and manufactured by Bio Medic Data Systems (Maywood, NJ), this device is
the only commercially available injectable RFID transponder that senses a biological parameter and uses
reverse telemetry to communicate the temperature of the animal as well as the animalʼs identification code to
the extracorporeal transmitter/reader. A new Bio Medic Data transponder type also permits writing information
into the implanted transponder through the use of forward telemetry. The data are stored in electrically
erasable programmable read-only memory (EEPROM memory), via forward telemetry, within the
micromodule, and can be extracted via reverse telemetry.

By the mid-1990s, injectable RFID was a well-recognized industry, providing a technology base for research on
similar injectable electronic devices for medical use.

Microstimulator Development
Based in part on the success of the commercial RFID transponder, the neuroprosthesis program of the National
Institute of Neurological Disorders and Stroke, at the National Institutes of Health issued a request for proposal
in October 1987 ( 33 ). This request for proposal solicited contractors to develop a single-channel implantable
microstimulator and extracorporeal transmitter for FNS. The concept was to use technology similar to the
commercial RFID transponders to eliminate the traditional “Portuguese-man-of-war” arrangement of lead
wires connecting large numbers of intermuscular and nerve-cu� electrodes to a centralized implant receiver
package, that is, the “pacemaker approach.” Lead wires have historically been associated with breakage,
tethering, and spread of infection ( 6 , 9 , 29 , 34 ). The request-for-proposal workscope defined a family of
untethered injectable micromodules that could be powered by a transcutaneous link and could be individually
commanded to produce electrical stimulation. Two groups were awarded contracts for microstimulator
development, one at the University of Michigan (Ann Arbor), and one at the Alfred E. Mann Foundation (AEMF)
(Sylmar, Calif). Each of these groups took varied approaches to microstimulator design. Subsequent contracts
were awarded to both groups in 1991 and 1994.

The Michigan Group ( 32 , 57 , 58 ) uses a thin-film substrate for fabrication of the stimulator electrodes, to which
complementary metal-oxide semiconductor (CMOS) electronics, a solenoidal microcoil, and a hybrid charge
storage capacitor are attached, as shown in the drawing in Figure 5 . A photograph of the Michigan
microstimulator is shown in Figure 6 . Sealing of the assembly for protection from body fluids is accomplished
through the use of an inverted glass capsule covering the electronics and electrostatically bonded to the thin-
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the microstimulator electronics by the internal hybrid charge storage capacitor. Unique features of this
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electronic devices. In 1993, Najafi & Wise ( 31 ) filed a patent application for a “Single Channel Microstimulator.”

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Figure 5  Exploded view of the University of Michiganʼs microstimulator. The glass capsule
covers the electronic components and hermetically seals the assembly. (Drawing courtesy of
the University of Michigan.)

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Figure 6  Two University of Michigan microstimulators on a US penny. In the upper device, the glass
capsule has been broken to expose visually the internal components. The lower device is intact.
(Photograph courtesy of the University of Michigan.)

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The microstimulator of the Mann Foundation group ( 4 , 27 , 28 , 53 ) uses a glass capsule similar to those of RFID
transponders. Figure 2 shows a photograph of the Mann Foundation microstimulator. A metal stimulating
electrode protrudes from each end of the glass capsule. As seen in an exploded view of the internal
microstimulator components ( Figure 7 ), all electronics, except for a rectifier diode, are contained on a single
thin-film, integrated-circuit chip. More recent designs combine the rectification elements into the integrated-
circuit chip. Sealing of the microstimulator is accomplished through the use of glass-on-metal seals at each end
of the capsule. The chip is electrically connected to a solenoidal microcoil via metal pads on a ceramic
substrate. Important features of this design are (a) the placement of the integrated circuit within the ferrite core
of the microcoil, maximizing the volume of the microcoil for improved magnetic coupling, (b) the use of a
compression spring for making electrical contact between the internal electronics and the stimulating
electrodes, and (c) a tantalum pentoxide-on-tantalum charge storage electrode that eliminates the need for a
discrete charge storage electrode. In 1991 and 1993, Schulman, Loeb, Gord, Strojnik, and Troyk ( 38 , 39 ) filed
patent applications for an “Implantable Microstimulator” with the “RFID-transponder” packaging approach.

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Figure 7  Exploded view of the Mann Foundation microstimulator. Note the placement of the integrated
circuit within two halves of the ferrite core. The coilʼs windings and the glass tube are not shown.

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Technological Challenges To Micromodule Design

Transcutaneous Magnetic Coupling


Power for operating the micromodule and telemetry must be transmitted over a single inductive link. The
magnetic coe�icient of coupling, k, is a function of the relative diameters of the extracorporeal transmitter coil
and the micromoduleʼs microcoil and their separation. A typical micromodule has a diameter of <3 mm, and a
typical transmitter coil has a diameter of at least 9 cm. RFID tags may be implanted 2–6 cm beneath the skin,
and microstimulators may be implanted along the central axis of a limb. Transcutaneous links have been
analyzed by Donaldson & Perkins ( 12 ), Galbraith et al ( 18 ), and Heetderks ( 23 ). Finite element analysis has also
been used for transcutaneous link modeling. However, the definitive work on coupling of air-core coils was
done by Grover ( 19 ). Based on Groverʼs work, Troyk & Schwan ( 46 ) presented a simplified analysis for weakly
coupled links, typical of micromodule systems. By any analysis, the magnetic links of micromodule systems are
characterized by extremely low coe�icients of coupling, on the order of k = 0.01. This low value of k presents a
formidable problem for powering of the implanted micromodule. Su�icient energy must be coupled to the
micromodule for powering of the micromoduleʼs electronic circuitry, obtaining a su�iciently high micromodule
power supply voltage, and, in the case of microstimulators, delivering the desired electrical stimulus. Powering
of the micromodule through the low-k magnetic link is the dominant electrical design problem for injectable
micromodules.

One approach for improving the power coupling between the transmitter and micromodule and obtaining the
required micromodule power supply voltage was presented by Heetderks ( 23 ) and uses a large quality factor
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(QPrivacy Policy coil and micromodule microcoil. In his analysis, Heetderks used a Q of 40 for both the
) for the transmitter
transmitter coil and the microcoil. In the transmitter, using a high-Q circuit has distinct advantages. Most of the
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transmitter power losses are from the I2R losses of the transmitter coil, resonant circuit, and
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Reducing these losses by raising the Q of the transmitter circuit has the beneficial e�ect of reducing the power
supply requirements for the transmitter circuit while increasing the attainable transmitter coil current.
However, in the micromodule, use of a high-Q coil is o�en undesirable and not practical. As pointed out by 

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Heetderks, the impedance match between the microcoil and the micromodule electronic circuitry becomes
increasingly unfavorable as the microcoil Q is increased. Using a high Q for both the transmitter and the
micromodule requires that the resonant frequency of both circuits be closely matched. Also, the telemetry data
bandwidth becomes unacceptably low for a high-Q microcoil.

Troyk & Schwan ( 51 , 52 ) have dealt with the inherently low coe�icient of coupling by using a somewhat
di�erent approach. They have developed a closed-loop class-E transmitter driver that is capable of producing
amperes of current in the transmitter coil at radio frequencies. By using a large value of transmitter coil current,
the Q of the micromodule can be set to a lower value. In their scheme, the Q of the transmitter circuit is raised
to an unusually high value, 120–180. Use of the high transmitter Q reduces the transmitter power supply
consumption to very low levels. Driving large currents into high-Q coils has historically been problematic when
using push-pull–type drivers. Although one can reduce the loss of a push-pull series RLC circuit by using low-
loss dielectric capacitors and litz wire for the transmitter coil, o�en the power loss is simply shi�ed from the
resonant RLC circuit to the push-pull drivers. The class-E topology ( 41 ) resolves this issue by using a
multifrequency resonant network. The power loss within the single-transistor active driver can be su�iciently
reduced so that the low resistance of the high-Q transmitter coil becomes the dominant loss. In fact, for class-E
transmitters it is desirable to use as large a circuit Q as possible.

One serious problem with class-E circuits is maintaining operation at the precise class-E frequency. For each
circuit, there is only one combination of operating frequency, duty-cycle, and coil-Q that will produce the
class-E conditions. Automatically maintaining the class-E frequency for transcutaneous coil drivers has been
demonstrated through the use of voltage-mode ( 61 ) and current-mode ( 45 , 52 ) feedback. These techniques
convert the class-E converter into a power oscillator whose frequency is established by the closed-loop control
circuit and the characteristics of the multifrequency network. The power-oscillator approach solves another
problem associated with driving large currents into the transmitter coil. Mechanical deformations of the
transmitter coil or proximity to metal objects will shi� the inductance and resistance of the transmitter coil.
When using a high-Q push-pull approach, the driving current rapidly drops as the self-resonant frequency of
the RLC output circuit shi�s away from the frequency of the input drive signal. For the class-E circuit, without
closed-loop control, shi�ing of the class-E frequency away from that of the input drive signal results in almost
instantaneous destruction of the transistor driver. Using the closed-loop class-E power oscillator approach
enables the frequency of the transmitter to shi� automatically to compensate for the changes in the
transmitter coil characteristics, thus maintaining the low-loss class-E operation. The result is a transmitter in
which transmitter coil currents of several amperes can be produced with relatively low transmitter power
supply currents. Low transmitter supply currents are important because most RFID and microstimulator
applications require portable extracorporeal transmitters, powered by batteries. A disadvantage to using the
closed-loop class-E power oscillator is that the transmitter frequency is not constant. Because the
micromoduleʼs internal clock is typically recovered from the transmitter frequency, the implanted
micromoduleʼs clock frequency is also variable. Therefore, it is necessary to use the variable frequency of the
transmitter as the overall systemʼs master clock. Both the University of Michigan and the Mann Foundation
microstimulator systems use closed-loop class-E transmitter circuits operating at a nominal frequency of 2
MHz. The Trovan RFID transponder system uses current-mode closed-loop class-E control at a nominal
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while maintaining low transmitter power loss.


Telemetry
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Both forward and reverse telemetries use the same transcutaneous magnetic link. In read-write RFID systems,
forward telemetry is used to infrequently change the micromoduleʼs identification code or store other user-
defined information in the RFID tag. For microstimulators, the forward telemetry has a more demanding
function. Commands for each microstimulator, specifying the stimulation parameters of each FNS stimulation
channel, need to be sent to the implanted microstimulators on a continuous basis. For typical FNS
applications, stimulation frequencies for each microstimulator might be ∼10–100 Hz, and each cycle of the
stimulus train must be individually controlled. Therefore, the forward telemetry data rate needed for
microstimulators is typically greater than what would be required for RFID tags.

Reverse Telemetry RFID systems require rapid reading speeds, using reverse telemetry, so that the animals
can be automatically identified while moving. This requires a high reverse-telemetry data rate.
Microstimulators currently have no compelling need for reverse telemetry, although, for practical FNS systems,
implanted-sensor micromodules would be needed to implement closed-loop control of muscle movements.
These sensor micromodules would use reverse telemetry to communicate with the extracorporeal transmitter
or possibly with other implanted micromodules. However, the reverse data rate needed for these sensor
micromodules is probably less than that needed for the forward telemetry of the microstimulators.

As a result of these varying needs, RFID developers have placed more emphasis on research into methods for
improving the reverse-telemetry rate for injectable RFID tags, and microstimulator research has emphasized
the development of new high-speed methods for forward telemetry.

The major problem associated with reverse telemetry is the sensing of the weak reverse-telemetry signal at the
site of the extracorporeal transmitter (reader) in the presence of the intense transmitter power field. Reverse
telemetry is accomplished by creating and modulating a reverse-telemetry data carrier within the microcoil.
The modality of transmission from the micromodule to the transmitter/reader is magnetic. The weak data
carrier magnetic field must be sensed at the site of the transmitter/reader. There are two basic methods of
reverse telemetry. They are o�en referred to as “half duplex” and “full duplex.” Although not meeting the strict
definition of these terms, from a communications standpoint, half duplex is used to describe systems for which
the transmitter coil current is turned o� while the micromodule communicates with the receiving circuit in the
transmitter/reader. Full duplex is used to describe systems for which the transmitter coil current is maintained
while the micromodule sends back the reverse-telemetry signal to the transmitter/reader. Both the full- and
half-duplex approaches have individual advantages and drawbacks.

The half-duplex approach, as used by the Texas Instruments Tiris® system, simplifies design of the receiver
within the extracorporeal transmitter/reader. For most injectable RFID systems, the magnitude of the
transmitter field at the site of the transmitter/reader is >150 dB larger than that of the reverse-telemetry field
produced by the micromodule. Half-duplex systems overcome the interference caused by the transmitter by
turning o� the transmitter current for a brief period while the micromodule sends the reverse telemetry.
Because during the transmission of the reverse telemetry the transmitter is not operating, the reverse-
telemetry data carrier can be at the same frequency as that of the transmitter. This is advantageous because
the transcutaneous inductive link is optimized for operation at the transmitter frequency. Typically, the self-
resonant frequency of the microcoil is used to tune a local oscillator within the micromodule. Cookie SettingsIn the
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transmitter/reader, the transmitter coil is used to sense the magnetic field produced by the micromodule with
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transmitter is turned o�. The power supply capacitor needed to store this energy is too large to be integrated
on the monolithic chip within the micromodule, and a separate hybrid charge storage capacitor is required. 
This complicates the internal structure of the micromodule, resulting in either larger micromodule size or
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smaller micromodule microcoil size.

Operation of the half-duplex micromodule is in two phases, a charging phase in which the transmitter coil
current is turned on and the micromodule power supply storage capacitor is charged, and a reverse-telemetry
phase in which the transmitter coil current is turned o� while energy stored on the micromoduleʼs power
supply capacitor is used to generate the reverse-telemetry signal.

The full-duplex approach is used by most RFID systems. In full-duplex mode, the transmitter coil current is
maintained, even during the reverse-telemetry transmission. The micromodule is continuously powered by the
extracorporeal transmitter, while the micromoduleʼs internal circuitry superimposes the data carrier on the
microcoil, together with the extracorporeal transmitter power signal. The advantages to this approach over the
half-duplex method are (a) the elimination of the charging phase and (b) the elimination of the separate
micromodule hybrid power supply capacitor. Because the micromodule is continuously powered, the power
supply capacitor can be of a su�iciently small value that it can be integrated on the monolithic silicon chip.
Elimination of the separate power supply capacitor allows for a smaller micromodule or more volume that can
be dedicated to the microcoil, thus increasing the coupling coe�icient to the extracorporeal transmitter coil.
The disadvantage of this approach is that the receiver circuitry within the transmitter/reader must sense the
weak reverse-telemetry signal in the presence of the large transmitter coil current.

One method of dealing with the interference caused by the large transmitter coil current is to place the reverse-
telemetry signal on a data subcarrier, which is far removed from the transmitter frequency, and to use
bandpass filtering to reduce the magnitude of the transmitter signal. This is the approach used by IDI/Destron
and many other RFID manufacturers. Unfortunately, for this method to be e�ective, the data subcarrier has to
be ∼10 times lower in frequency than the transmitter signal, resulting in a reduced data rate for the reverse
telemetry.

Another method ( 47 ) uses a combination of di�erential receiver coils within the transmitter/reader and a data
carrier, which is one-half of the transmitter frequency. Used by the Trovan LID-500 reader, two di�erentially
connected receiver coils within the extracorporeal transmitter coil are geometrically placed so as to cancel
magnetically the transmitter coil field. The inductance of the receiver coils is large compared with that of the
transmitter coil; therefore, the sensitivity to the weak reverse-telemetry signal is high. Although the di�erential
receiver coils cannot produce a perfect null of the transmitterʼs power-field signal, the transmitterʼs signal is
su�iciently reduced that the data subcarrier frequency can be set to one-half that of the transmitter. Within the
micromodule, the simultaneous modulation of the data subcarrier at one-half the transmitter frequency,
combined with the transmitter signal, produces two reverse-telemetry components, one at a lower sideband of
one-half of the transmitter frequency and one at the data subcarrier fundamental, also at one-half of the
transmitter frequency. This coincidence of the data subcarrier fundamental and the lower sideband maximizes
the strength of the reverse-telemetry signal, while retaining a high reverse-telemetry data rate. The
disadvantage of this method is that the magnetic structure within the extracorporeal transmitter/reader is
more complex.

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including demodulation circuitry in the micromoduleʼs circuitry. Most RFID systems use forward telemetry for
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Modulation of the large transmitter coil current is di�icult. The high-Q transmitter coil that facilitates the design

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of the class-E transmitter resists rapid changes in its coil current. Two techniques have been described for
amplitude modulating the class-E converter. Ziaie et al ( 58 ) report the modulation of the transmitterʼs direct
current (DC) power supply using a transistor switch. The response time of the converter is dictated by the
multifrequency networkʼs Q and the size of the converterʼs input choke. Because the transistor switch carries
the transmitterʼs power supply current, additional power losses result. Troyk & Schwan ( 52 ) report the shi�ing
of the class-E converterʼs operating point via the closed-loop control circuit to accomplish amplitude
modulation of the transmitter coil current. The response time of this method also depends on the size of the
converterʼs input choke and the multifrequency networkʼs Q. The amplitude modulation can be used to
describe two states of the transmitter current that can be digitally modulated by Manchester, pulse-width, or
pulse-position encoding. Both of these techniques are limited by the natural response of the transmitterʼs
high-Q circuitry and can be used for data rates that are not much higher than 1/10 the transmitter frequency.

Schwan et al ( 40 ) and Troyk et al ( 50 ) have reported an alternative method of class-E transmitter modulation.
Known as the “suspended-carrier” method, it permits the transmitter to be placed in a suspended state in
which all of the energy contained within the converterʼs multifrequency network is contained in the resonant
capacitors. While the transmitter is in the suspended state, the energy loss is minimal. Resumption of normal
operation can be nearly instantaneous, producing 100% modulation. This technique permits the transmitter
current to be turned on for as little as one cycle and turned o� for an arbitrary period of time. Transient
responses within the micromoduleʼs microcoil make it advantageous to turn the transmitter o� for an integer
number of cycles. Suspended-carrier modulation permits forward-telemetry data rates that approach the
transmitter frequency. Advantages to this method are that the suspension of the transmitter carrier can be
used to implement a half-duplex reverse telemetry system and that the carrier can be suspended to allow
implanted micromodules to perform sensitive bioelectric sensing such as electromyographic or M-wave
detection. Detection of the 100% modulation within the micromodule can be accomplished with minimal
integrated circuitry and does not depend on the Q of the microcoil.

Packaging
The small size of the injectable micromodule not only poses an electrical problem, owing to the low magnetic-
coe�icient of coupling, but also presents a challenge for protection of the micromoduleʼs internal components
against the deleterious e�ects of body fluids. For the micromodule to be passed through a hypodermic needle,
the packaging surrounding its internal components must not compromise its physical size. Beginning with the
initial RFID tags, researchers have sought compact packaging methods for protecting the injectable
micromodule from the implanted environment.

Water within a micromoduleʼs package can cause deterioration in two basic ways. First, water that condenses
within the microcoilʼs electrical windings can shi� the resonant frequency of the microcoil. This e�ect can be
dramatic because the dielectric constant of water is ∼80-fold that of air. Water that fills the gap between the
layers of the microcoilʼs wire windings raises the e�ective capacitance of the microcoil. The result is a lowering
of the coilʼs resonant frequency. Because energy transfer across the transcutaneous inductive link depends on
a reasonable match between the micromoduleʼs self-resonant frequency and the frequency of the
extracorporeal transmitter, the presence of water within the microcoil can cause the micromodules to cease
operation owing to insu�icient power supply voltage. Second, water that condenses on Settings
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conductors of the micromoduleʼs electronic components can cause galvanic or bias-driven corrosion of the
metal conductors.
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stores data classic formtoofenable
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implant electronics is beyond the scope of this text.

In the early 1980s, injectable RFID tags were nonhermetically packaged in plastic sleeves. By the mid-1980s,
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enclosure within a sealed cylindrical glass capsule was the most economical and reliable method of packaging.
Initially, closure of the glass capsule containing the micromoduleʼs coil and electronics was accomplished by
using microtorches to melt the ends of the capsule while it was slowly rotated. This method proved too slow for
volume production and required skilled training of an operator to obtain reliable and repeatable seals. In
addition, the microtorch produced water vapor that could enter the package during sealing. O�en while
forming the final melted glass seal, the water vapor or other trapped gasses within the capsule would expand
and create a leakage path through the capsule. By the early 1990s, RFID tag manufacturing had become
automated and laser sealing systems were developed to reliably seal large numbers of glass-encapsulated
transponders.

Although the RFID industry adopted the sealed-glass capsule as a de facto standard, it was not obvious that the
same approach could be used for microstimulators. The RFID tag is a unique assembly in that there are no
electrical conductors that must exit the glass capsule. Therefore, the RFID tagʼs internal components can be
completely surrounded by the glass. For microstimulators, at least two electrical connections for the
stimulating electrodes must exit the packaging. Use of a cylindrical glass capsule to seal microstimulators
required the development of glass-on-metal seals that could be integrated with the sealed-glass capsule. This
proved to be a significant technical challenge.

The Mann Foundation group elected to adopt the RFID glass-capsule approach to microstimulator packaging (
4 , 28 ), as shown in Figure 2 . Beginning with the microtorch approach, failure mechanisms similar to those seen
in the early RFID industry emerged. Migrating the assembly methods to laser sealing was considerably more
di�icult than for the RFID tags. Residual stress within the glass-to-metal seals o�en produced microcracks
along the metal-glass interface. Matching the coe�icient of thermal expansion between the glass and the metal
electrode stems was complicated by the use of two di�erent metals for each of the simulating electrodes,
iridium and tantalum. These problems were ultimately resolved by using a tantalum metal tube at one end of
the capsule and a solid tantalum metal stem at the other end. The tube allows gases to vent during the final
seal and allows for back filling with an inert atmosphere. A disadvantage of this technique is that it is di�icult to
extend to multiple feedthroughs.

The University of Michigan group chose an entirely di�erent and novel packaging scheme ( 58 , 59 ). As shown in
Figure 5 , a thin-film substrate is used for the basis of the microstimulator fabrication. The wa�le electrodes and
substrate interconnects are fabricated on a silicon substrate by using multiple layers of polysilicon conductors,
phosphosilicate glass, and low-temperature oxides. Polysilicon conductors covered by phosphosilicate glass
and low-temperature oxides exit the central area of the substrate under a ring of planar polysilicon. Substrate
fabrication requires a total of six masking steps. The central substrate area is used to interconnect the
microstimulatorʼs electrical components. A bathtub-shaped Pyrex glass capsule is electrostatically bonded to
the planar polysilicon at a temperature 320°C with a voltage of ∼2000 V. The polysilicon conductors under the
glass capsule form multiple feedthroughs. One disadvantage to this technique is the susceptibility of the
dissolution of the polysilicon-glass interface at elevated temperatures ( 11 ).

Features Of Specific Radio Frequency Identification And Microstimulator Systems


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Radio Frequency Identification
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permit complete descriptions of all of these. Two systems have been chosen as representative of the state of
the art and are described below.

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The Trovan System Trovan manufactures the ID-100 injectable RFID transponder. Shown in Figure 1 , it is
physically composed of a laser-sealed green glass capsule containing a 0.5 mm × 0.5 mm-sized silicon chip and
a microtransformer based on the DeMichele patent ( 10 ). The ID-100 has a diameter of 2.2 mm and is 11.5 mm
long. The transformer is wound with two copper wire windings, a primary and a secondary, around a ferrite
core. The start and finish of the secondary winding are connected directly to the silicon chip by using gold
bump technology described by Hadden & Zirbes ( 21 , 22 ). This fabrication technology is unique in that no
interconnection substrate is required, maximizing the available volume within the glass capsule for the
microtransformer, thereby maximizing the magnetic-coupling coe�icient to the transmitter/reader. Winding of
the transformer and welding of its wires take place on one automated machine. The glass capsule is
subsequently sealed by using a custom high-speed laser-sealing machine.

The ID-100 electronic chip is fabricated with a 2μm, p-well, CMOS process. Programming of each chipʼs 64-bit
memory is performed at the wafer stage by automatic laser cutting of polysilicon links. Once programmed, the
memory cannot be altered. Thus, the ID-100 is a fixed-code laser-programmed device. Although some
applications demand the ability to change the identification code, once implanted into the animal, a fixed-code
laser-programmed device is commonly regarded as the ultimate in identification security. The ID-100 enables
each implanted animal to have a unique identification number that can be cross-referenced with a computer
database for maintaining the lifetime history of the animal.

The ID-100ʼs excitation frequency (from the transmitter/reader) is nominally 128 kHz, and the reverse telemetry
is placed on a data subcarrier of one-half the transmitter or nominally 64 kHz ( 49 ). Reverse-telemetry data
modulation is by phase shi� keying ( 49 ), using eight data subcarrier cycles per bit, resulting in a reverse-
telemetry rate of 8 kbits/s. The ID-100 has one of the fastest reverse-telemetry rates of low-frequency RFID
transponders. On receiving power from the transmitter/reader, the ID-100 clocks out its 64-bit memory
contents in a continuous repeating cycle.

Trovan manufactures a number of transmitter/readers for use with the ID-100. The most commonly used of
these is the LID-500 ( Figure 8 ). The transmitter coil is contained in the flat, dishlike portion of the LID-500. The
transmitter uses current mode closed-loop class-E driving of a 15.5-cm (diameter) litz wire coil with a current of
∼5 A peak, although the battery current is less than 1/10 the peak coil current. To conserve battery power, the
transmitter is pulsed. Within the LID-500 dish, two di�erential receiver coils detect the reverse telemetry from
the ID-100. The combination of the high transmitter current from the class-E converter, the one-half
transmitter-frequency data subcarrier, and the sensitive di�erential receiver coils provides the Trovan system
with an unusually large reading distance. Typically, reverse telemetry from the ID-100 can be detected by the
LID-500 with the ID-100 placed >16.5 cm from the face of the LID-500. When other transmitter/readers are used,
this distance can be extended up to 33–40 cm. Like most transmitter/readers of other manufacturers, the
LID-500 uses digital signal processing to determine the veracity of the reverse telemetry. An internal
microprocessor can store the codes from numerous transponder readings for subsequent upload to a
computer via an RS-232 port.

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A number syringe injection systems have been developed for use with the ID-100 and other RFID
transponders. One such injector is shown in Figure 9 . A rotary magazine of sterilized transponders can be
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loaded into the injector for rapid and repetitive implantation into livestock. Trovan also has
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method of transponder implantation ( Figure 10 ). The Trovan® ZIP Quill™ is an injectable tag that does not
require the use of an injector. A solidified glucose-based encapsulation is molded into a sharpened shape. The
ZIP Quill can be injected into the animal by hand, by pressing the pointed tip of the assembly through the 

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animalʼs skin. Once inserted, the
glucose dissolves, leaving the
ID-100 in place.

Figure 8  Commercial RFID hand-held reader. The transmitter, transmitter coil, and receiving coils are
located in the frontal dishlike structure. (Photograph courtesy of Trovan® LTD.)

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Figure 9  Commercial RFID tag injector. The rotary magazine is loaded with multiple sterilized
transponders. (Photograph courtesy of Trovan® LTD.)


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Figure 10  Trovan® Zip Quill™ injection system. The transponder and internal push-rod, viewed separately
and encapsulated by the glucose-based injector, are shown. (Photograph courtesy of Trovan® LTD.)

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The Bio Medic Data Systems Temperature RFID System Bio Medic Data Systems manufactures the IPTT-100,
an injectable RFID tag with temperature sensing and reprogramming capability. The target market for the
IPTT-100 is research animal laboratories. The user may program up to 16 alphanumeric characters and store
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Policy is fabricated from
EEPROM. Physically the IPTT-100 is sealed in a clear glass capsule, has a 2.2-mm diameter, and is 14 mm long.
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This is not surprising, because the support circuitry for EEPROM cells typically uses considerable area on a
CMOS chip. Consequently, the microcoil is somewhat shorter than other commercial RFID transponders. This
would suggest a shorter reading distance than that of other RIFD tags such as the Trovan ID-100. The 
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specification sheets for the IPTT-100 list the nominal reading distance as “proximity, noncontacting.” the range
for which the IPTT-100 can sense temperature is 90°–110°F, and the 0.1°C resolution and the 0.5°C accuracy are
impressive. The combination of the EEPROM memory and the temperature sensing make the IPTT-100 a unique
RFID tag; this tag combines sensing of a biological parameter with forward and reverse telemetry in an
injectable package. The IPTT-100 operates at 400 kHz with a total reading time of 40 ms.

Bio Medic Data Systems manufactures a number of transmitter/readers with state-of-the-art keypad and
computer interfaces. The IMI™ II implanting handle allows quick mounting of the prepackaged, sterilized
tag/needle assembly and is suitable for low-volume injection of the tag.

Mann Foundation Microstimulator


The microstimulator ( Figure 2 ) was designed, under National Insitutes of Health (National Institute of
Neurological Disorders and Stroke) funding, by a consortium of the AEMF (Sylmar, Calif.), the Illinois Institute of
Technology (Chicago, Ill.), and Queenʼs University (Kingston, Ontario, Canada) and is based on an RFID
packaging approach. The microstimulator integrated circuit is fabricated on a commercial 1.2-μm double-
metal, double-poly, n-well CMOS process. Currently, the AEMF microstimulator design is being developed into a
commercial microstimulator known as the BION™. The BION is characterized by functional specifications that
make it applicable to a wide range of clinical uses.

System Architecture The AEMF microstimulator system operates on a transmitter carrier frequency of 2 MHz
and uses forward telemetry to control all of the stimulation parameters. No reverse telemetry is used. The
transmitter is a current-mode, closed-loop class-E converter. Forward telemetry is accomplished by 5%–10%
amplitude modulation of the 2-MHz carrier. Digital commands to the microstimulator use Manchester
encoding. Sixteen transmitter carrier cycles are used per bit for a bit period of 8 μs. A “0” is encoded by leaving
the carrier amplitude fixed throughout the bit period, and a “1” is encoded by changing the carrier amplitude
in the middle of the bit period. This is commonly known as frequency modulation coding, and is the same as
that used in older single-density floppy disks. An advantage of frequency modulation coding is that the long-
term average level of the carrier is constant. This constant average level makes detection of the data transitions
within the microstimulator easier by reducing the e�ect of the previous bits. A fixed-length 36-bit digital device
command word is used to control all functional parameters of the microstimulator. Each device command
transmitted to a microstimulator controls one individual stimulation pulse. Contained within the device
command are the 8-bit device address, the 8-bit pulse width, and an 8-bit mode control word. To obtain a
specific pulse repetition rate for an individual microstimulator, commands are sent to that microstimulator at
the desired repetition rate. Operating at the maximum rate, the system is capable of addressing up to 256
microstimulators with 3400 commands per second. Data published by Loeb et al ( 28 ) show that 69 separate
devices could be sequentially activated at a stimulus frequency of 50 Hz.

Between stimulation pulses, the command stream from the transmitter is in an idle mode comprising an
alternating pattern of ones and zeroes. When addressing a microstimulator, a header string of five zeroes
followed by a one is initially sent, creating a unique pattern that is never duplicated within the command word,
because the device command contains “fence-post” one-bits (1 for each 4 bits of command data). A�er the
6-bit header are three 8-bit (plus 2 fence-post bit) commands, resulting in the totalCookie of 36Settings
bits per device
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command. The first word specifies the microstimulator address (0–255), and a microstimulator is activated only
when this word
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the stimulus pulse width (1–256 μs in 1-μs increments). The third mode control word specifies the stimulus
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amplitude (0–30 mA in two ranges of 15 linear steps of 0.2 and 2 mA, respectively), the electrode recharge
current (20 or 200 μA), the shape of the end of the stimulus pulse (square or exponential tail of 300 μs), and a 
single parity bit. The square or exponential tail was included in the design to accommodate anodal block as
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suggested by Fang & Mortimer ( 16 ).

Electrodes and Current Drivers The electrical stimulus produced by the microstimulator is a monophasic,
charge-balanced, constant-current pulse. The small package size provides little space for an electrode-blocking
capacitor. An electrode isolation capacitor is essential for microstimulators because failure of the
microstimulatorʼs output current driver could result in constant direct current flowing between the two
stimulation electrodes. In the AEMF design, the requisite blocking capacitor is included as part of one of the
stimulating electrodes. The stimulus electrode is fashioned from a sintered, anodized tantalum slug and acts as
a “capacitor electrode” with respect to the body fluids, as originally described by Guyton & Hambrecht ( 20 ).
The porous tantalum provides a large e�ective surface area to lower the electrode-tissue interface impedance.
The tantalum pentoxide-on-tantalum capacitor has a large capacitance (5–15 μF), is characterized by a very low
DC leakage current, and, if damaged, tends to self-heal in the body fluids ( 37 ). The reference electrode is
polarized cathodically with respect to the stimulus electrode and is made from electrochemically activated
iridium ( 36 ).

The constant-current output drivers function by using recharge current to store charge on the tantalum
electrode during the interpulse interval, then by using that stored charge to generate the constant-current
stimulus pulse. The value of the recharge current is specified in the command word. To maintain a constant
stimulus current throughout the stimulus pulse, the prestimulus voltage that sets the compliance voltage on
the tantalum electrode must be large enough so that su�icient charge is stored on the tantalum electrode.
Recent versions of the AEMF microstimulator are capable of a compliance voltage of up to 17 V.

Packaging The RFID glass-capsule approach has already been described above. In a similar construction, the
AEMF microstimulator is sealed in a borosilicate glass capsule. Three other unique features of the AEMF
microstimulator are the use of a sandwich-like structure for physically integrating the microcoil and the
integrated circuit, a compression spring for making electrical connection between the fixed-distance electrodes
and the internal microstimulator components, and an internal moisture getter.

The sandwich structure is shown in Figures 2 and 7 . The ferrite core for the microcoil is composed of two halves
adhered on each side of the substrate to which the integrated circuit is mounted. The wire coil is then wound
around the combination. Because the e�ective permeability of the core is a function of the coreʼs length-to-
diameter ratio, and the coupling to the extracorporeal transmitter coil increases with increasing core length,
this physical arrangement e�ectively uses the volume within the capsule to maximize the surface area of the
integrated circuit while maximizing the magnetic coupling to the transmitter.

The compression spring solves the problem of how the microstimulatorʼs internal electronics are connected to
the exiting electrodes. Adapted from “S-wires” used in glass diodes, ∼4 kdynes of force are placed on the spring
before glass-capsule sealing.

Owing to the extremely small volume of the microstimulator package, conventional leak-testing methods are
insu�icient to ensure through leak testing alone that the microstimulator is adequately sealed against moisture
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vapor that could pass through a leak small enough to be below the limits of leak detection could
raise the relative humidity within the microstimulator package to 100% relative humidity within ∼200 days. To
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increase the e�ective internal volume of the microstimulator, a moisture getter composed of a 1-mm³ crystal of
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a hygroscopic salt, MgSO4, within a silicone rubber capsule is placed within the sealed-glass capsule.
Considering the capacity of the getter and the fact that the implanted microstimulator is kept at constant
temperature, a leak just below detectable limits would take >9000 years to reach saturation of the 
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microstimulator capsule ( 4 ).

Implantation of the microstimulator uses an insertion tool based on a conventional Intracath™ consisting of a
12-gauge plastic sheath over a sharp trochar needle. The hub of the trochar has been modified to connect to a
conventional laboratory stimulator that is used to determine when the microstimulator is near the desired
biological stimulation site.

Transmitters Three di�erent sizes of transmitter coils and associated transmitter/controllers have been
tested. The first is a 9-cm-diameter × 17-cm-long, 9-turn helical coil designed for use around a patientʼs
forearm. The second is a 9-cm-diameter × 2-cm-thick coil for use on the surface of a subjectʼs skin. The last is a
19-cm-diameter × 38-cm-long helical coil in which an entire cat might be placed for laboratory experiments. For
each of these coils, a tuned, closed-loop class-E converter is interfaced to a microprocessor controller.

University of Michigan Microstimulator


The University of Michigan microstimulator shown in Figures 5 and 6 was also designed under National
Institutes of Health (National Institute of Neurological Disorders and Stroke) funding. As described above, the
packaging approach is based on electrostatic bonding of a glass capsule to a thin-film substrate. Dimensions of
the microstimulator are 2 mm × 2 mm × 10 mm. The microstimulatorʼs integrated circuit is fabricated by using
the University of Michiganʼs deep-boron di�usion, 3-μm, single-metal, double-poly, p-well CMOS process. An
important feature of this process for microstimulators is the presence of isolated diodes, facilitating on-chip
rectification.

System Architecture The Michigan microstimulator operates on a transmitter frequency of 2 MHz and uses
amplitude-modulated forward telemetry for control of the stimulus parameters. No reverse telemetry is used.
The transmitter is a voltage-mode–controlled closed-loop class-E converter. A 20% amplitude modulation of
the 2-MHz transmitter is used to encode the digital forward telemetry commands. Commands to the
microstimulator use pulse-width modulation of the amplitude-modulated transmitter during a bit time of 100
μs to define two digital states.

Each command to a microstimulator comprises a 5-bit address (for a possible 32 di�erent microstimulators)
followed by a time period corresponding to the desired stimulus pulse width, for which the transmitter is
maintained at the 80% modulated level. A�er the stimulation period, the carrier is restored to the 100% level,
ready for addressing the next stimulator. Because the stimulus pulse width is not digitally encoded, the
duration of the command sequence depends on the specified pulse width. Between stimulation pulses, the
transmitter is maintained at the 100% level. The stimulus amplitude is fixed at a constant current of 10 mA,
with a 200-μs maximum pulse width. Because the duration of the stimulus pulse width is directly controlled by
the state of the transmitter, a minimum pulse width of 10 μs with steps of 1 μs is possible. For a nominal
stimulus pulse width of 100 μs, at least 600 μs of command addressing and stimulus width specification are
required. Extrapolating from data published by Ziaie et al ( 58 ), for a 100-μs stimulus, the maximum stimulation
frequency for a single microstimulator would be 570 Hz. For 32 devices, each device would need to be
sequentially addressed, and the maximum frequency for all 32 devices would be ∼18 Hz.
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Electrodes and Current Drivers The stimulation electrodes at each end of the thin-film substrate are
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fabricated from an anodically prepared iridium-oxide film deposited on the silicon substrate. Accept All Early square-
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shaped electrode designs su�ered from deterioration when placed in service, owing to nonuniform current
densities across the electrodeʼs surface and concentrated at the edges. More recently, a new wa�le-shaped
thin-film electrode reduces the current density at the perimeter of the electrode by segmenting the electrode

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area into smaller, 10-μs-diameter sites. Testing with 10-mA current pulses in phosphate-bu�ered saline shows
that the wa�le design is able to withstand over two billion pulses without any degradation ( 60 ).

A discrete 1-μF hybrid tantalum blocking capacitor is used to electrically isolate the iridium-oxide electrodes.
Between stimulus pulses, the hybrid storage capacitor is charged to the regulated 9-V compliance supply. On
detecting a matching command stream address, the controlled-current-output driver discharges the storage
capacitor through the iridium-oxide electrodes to generate the fixed-amplitude 10-mA stimulus pulse. At the
end of the stimulus period, a fixed 100-μA recharge regulator restores the charge on the capacitor.

Testing of Injectable Micromodule Systems

RFID manufacturers and microstimulator researchers have performed a variety of in-vitro and in-vivo tests
designed to help understand the safety and e�icacy of injectable micromodules. Although not all of these are
described here, the test results presented are representative of the type of investigations being pursued.

Radio Frequency Identification Industry Testing


Testing within the RFID industry has focused on migration of the implanted tags, biocompatibility of the
micromodule materials, and reliability of the implanted tags. Rao & Edmondson ( 35 ) performed a 2-year study
in mice to determine the stability of and tissue reaction to subcutaneously implanted RFID tags. They studied
the tissue response to RFID tags in mice (used in National Cancer Institute studies) implanted with Bio Medic
Data Systemsʼ devices. Histological studies performed a�er 24 months of implantation showed the
development of a thin coherent membrane consisting of fibrocytes and collagen fibers around the
micromoduleʼs exposed glass surface with no indication of neoplastic changes. They also found >95%
functional reliability of the implanted tags.

Ball et al ( 1 ) investigated RFID tags implanted in rats. In a 1-year study, they found no visible tissue reaction at
the injected micromodule implantation sites. Tissue surrounding the implants 2 weeks a�er injection consisted
of thin rims of immature fibrous connective tissue and sparsely located subacute inflammatory cells. A�er 52
weeks, thin rims of mature fibrous connective tissue surrounded the implant sites, and there was no evidence
of a persistent inflammatory reaction.

In other studies performed by Stärk et al ( 43 ) using Trovan tags to identify pigs, migration of the tags was
determined to be <1 cm from the original implantation site. Total populations of 244 piglets were tagged over 1
year. Despite the fact that a rapid-injection system for which the needle was not sterilized between injections
was used, <4% of the animals showed signs of infection at the implantation site.

In summary, experiences within the RFID industry during the past 15 years have shown excellent tolerance of
the injected micromodules by the host animals. In 1998, a�er an initiative by Electronic Identification Devices,
Inc. (Santa Barbara, Calif), the FDA informed several RFID manufacturers that no restrictions were planned for
the use of injected RFID tags in livestock and domestic pets.
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Microstimulator Testing
The
ThisUniversity of Michigan
website stores data such asmicrostimulator package
cookies to enable essential sitewas tested inasawell
functionality, studyas by Walter et al ( 56 ). In three male
cats, two orpersonalization,
marketing, three microstimulators
and analytics.were surgically
Privacy implanted on the serosal surfaceAccept
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surgical exposure of the bladder, the microstimulator packages were sutured at either the base midwall or
dome of each bladder. The implants consisted of sealed microstimulator packages containing no active

electronics; no electrical stimulation was performed. A total of eight microstimulator packages were implanted
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for an 8-week implantation period, allowing su�icient time for a bladder-wall injury response to occur. On
explanting, no perforation to the bladder lumen or migration from the bladder wall was observed. Histological
studies showed that the implants were surrounded with a thin connective-tissue sheath and a thickened
subserosal layer. Electron-microscopic examination of the explanted microstimulator packages showed no
physical deterioration of the glass capsule or electrode surfaces.

The implanted performance of the AEMF microstimulator has been reported in several studies ( 3 , 5 , 17 ). The
biocompatibility of the intact microstimulator, compared with nonfunctional passive implants, broken
microstimulator-type glass, silicone tubing, polyester suture material, and two of the internal components of
the microstimulator (ferrite core and silicon chip), was investigated in a comprehensive study by Cameron et al
( 3 ). In this study, intact microstimulator test specimens, as well as broken microstimulator component pieces,
were implanted into cat leg muscles, including tibialis anterior, extensor digitorium longus, medial
gastrocnemius, and lateral gastrocnemius. Insertion of the microstimulators was accomplished by using a 12-
gauge angiocath insertion tool. The component pieces were introduced with forceps into a bluntly dissected
muscle channel. The microstimulators were electrically activated on a weekly basis and muscle twitches
recorded. Durations of implantation depended on the implant and the particular animal and varied from 30
days to >100 days. Although the data of Cameron et al are too comprehensive to be repeated here, in general,
the foreign-body layers that surrounded the implanted devices were composed of two constituents, an outer
encapsulation layer of fibrous, cell-poor material and an internal accumulation of loosely packed inflammatory
cells composed primarily of macrophages and lymphocytes. Thickness of the layers depended on the type of
implant, with the glass-shard components seeing the most severe tissue reactions. All of the microstimulators,
functional and passive, elicited relatively benign inflammatory responses. The stable cellular responses were
accompanied by stable muscle twitch threshold measurements. Over a 100-day implantation period, twitch
thresholds showed little variation, and in some cases they decreased as healing of the implantation site
progressed.

Fitzpatrick et al ( 17 ) reported a new method, using fluorescent dye, of measuring the migration of
microstimulators and microstimulator-sized glass objects within mammalian muscle tissue. The implants were
introduced with a glucose/dye mixture that stained the surrounding tissues immediately a�er implantation.
Their findings, a�er a 7-week implantation period, are that a�er injection, the AEMF microstimulator
demonstrates little to no migration away from the implantation site.

In another study of the implanted AEMF microstimulator, Cameron et al ( 5 ) observed regional muscle
stimulation e�ects produced by injected microstimulators. This study is of particular importance to possible
FNS applications. Among their more significant findings is the observation that the intermuscular
microstimulators produced muscle force vs stimulus strength curves, as illustrated in Figure 11 , that were
characterized by a series of small steps as the stimulus was increased from threshold to the 100% recruitment
level. This might be explained by considering the distribution of nerve bundles relative to the microstimulator
site. Nerve branches contained within a common bundle will probably have similar stimulus thresholds,
explaining the plateau regions of the steps. For the stimulus current to reach the stimulus threshold for a more
distant bundle, a step increase in stimulation is required. Once the stimulus threshold for this new bundle is
reached, a new plateau caused by the tight physical grouping of the bundle branches results.
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Conclusions


Injectable micromodules, and in particular microstimulators, are representative of an exciting new technology
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that could potentially eliminate the “hardware
barrier” for the clinical implementation of
functional electrical stimulation. Research is
currently in progress for developing a family of
injectable micromodules that would be used as
the hardware basis for closed-loop FNS systems.
Undoubtedly, the function of micromodules will
be extended to include sensing of bioelectric
signals, muscle and joint position, and
acceleration of limb movements. The future
may see longer-term storage of energy within
the microstimulator circuitry through the use of
super capacitors or thin-film batteries. Such
systems could operate for short periods of time
without the presence of the extracorporeal
transmitter. Future micromodules may
communicate not only with the extracorporeal
transmitter but also directly with each other.
Also, using emerging on-chip inductor
technologies might completely eliminate the
need for hermetic enclosures, realizing Carrollʼs
concept ( 7 , 8 ) of the single-chip implant.
Although technological developments for the
engineering of injectable micromodules will
undoubtedly precede and continue to preempt
Figure 11  Possible model and stepped recruitment curve resulting from a their clinical use, the development of new
microstimulator implanted into muscle and near multiple nerve branches. Within
each group, the first fibers stimulated are those that lie closest to the clinical electrical stimulation strategies will
microstimulator. At a higher level of stimulation, fibers that are farther away are define overall system requirements.
activated. The size of the steps and the corresponding force depend on the fiber
type and physical distribution of the fibers. (See Reference 5 for details. Drawing
courtesy of Cameron et al.)
Clinically, the future may see injectable
micromodules used in a wide range of
Download Full-Resolution (/na101/home/literatum rehabilitative and therapeutic applications,
/publisher/ar/journals/content/bioeng
including stimulation of paralyzed muscle for
/1999/bioeng.1999.1.issue-1/annurev.bioeng.1.1.177
hand grasp and assisted walking, treatment of
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foot-drop in hemiplegic stroke patients,
shoulder subluxation a�er stroke, rehabilitation
a�er arthroplastic surgery, urinary stress incontinence, and treatment of chronic pain and spasticity.

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