USOO6553263B1

(12) United States Patent (10) Patent No.: US 6,553,263 B1

Meadows et al. (45) Date of Patent: Apr. 22, 2003

(54) IMPLANTABLE PULSE GENERATORS 4,379.462 A 4/1983 Borkan et al. .............. 128/786
USING RECHARGEABLE ZERO-VOLT 4,431,001 A 2/1984 Hakansson et al. ......... 128/421
TECHNOLOGY LITHIUM-ON BATTERIES (List continued on next page.)
(75) Inventors: Paul M. Meadows, La Canada, CA FOREIGN PATENT DOCUMENTS
(US); Carla M. Mann, Los Angeles, WO O2O98O8 7/2002
CA (US); Hisashi Tsukamoto, Sangus,
CA (US); Joey Chen, Valencia, CA OTHER PUBLICATIONS
(US) Tsukamoto, Hisashi, Kishiyama, Clay inventors for
(73) Assignees: Advanced Bionics Corporation, Q111-PRO; U.S. Provisional Patent Application Serial No.
Sylmar, CA (US); Quallion, LLC, 60/199,895; Filed Apr. 26, 2000; entitled “Zero Volt Capa
Sylmar, CA (US) bility for Lithium-Ion Batteries”.
c: - Primary Examiner-George R. Evanisko
(*) Notice: Subject to any disclaimer, the term of this ASSistant Examiner Roderick Bradford
patent is extended or adjusted under 35 (74) Attorney, Agent, or Firm Bryant R. Gold
U.S.C. 154(b) by 157 days. (57) ABSTRACT
(21) Appl. No.: 09/627,803 An implantable medical device, Such as an implantable
(22) Filed: Jul. 28, 2000 pulse generator (IPG) used with a spinal cord Stimulation
Related U.S. Application Data
(SCS) System, includes a rechargeable lithium-ion battery
having an anode electrode with a Substrate made Substan
(60) Provisional application No. 60/146,571, filed on Jul. 30, tially from titanium. Such battery construction allows the
1999. rechargeable battery to be discharged down to Zero Volts
without damage to the batterv. The implantable medical
(51) Int. Cl. .................................................. A61N 1/40 indiary civil and protection circuitry that
(52) U.S. Cl. ............................................ 607/61; 607/33 controls the charging of the battery So as to assure its reliable
s and Safe operation. A multi-rate charge algorithm is
(58) Field of Search .............................. 607/33, 34, 61, employed that minimizes charging time while ensuring the
607/32, 60 battery cell is safely charged. Fast charging occurs at safer
lower battery voltages (e.g., battery voltage above about 2.5
(56) References Cited V), and slower charging occurs when the battery nears full
U.S. PATENT DOCUMENTS charge higher battery voltages (e.g., above about 4.0 V).
When potentially less-than-Safe very low Voltages are
3,454,012 A 7/1969 Raddi ......................... 128/422 encountered (e.g., less than 2.5 V), then very slow (trickle)
3,724,467 A 4/1973 Avery et al. ... ... 128/418 charging occurs to bring the battery voltage back up to the
3,822,708 A 7/1974 Zilber .......... ... 128/419 Safer Voltage levels where more rapid charging can Safely
A CE E" - - - - - - - - - - - - - - - - - - - - -i 23. occur. The battery charging and protection circuitry also
3888.260 A 6/1975 Fischell r ... 12sf419 continuously monitors the battery voltage and current. If the
39 42,535 A 3/1976 Schulman .................... 607/33 battery operates outside of a predetermined range of Voltage
4,014,346 A 3/1977 Brownlee et al. . ... 128/419 or current, the battery protection circuitry disconnects the
4,082,097 A 4/1978 Mann et al. ...... ... 128/419 battery from the particular fault, i.e. charging circuitry or
4,231,027 A 10/1980 Mann et al. ... ... 340/636 load circuits.
4,338.945. A 7/1982 Kosugi et al. . ... 128/421
4,345,603 A 8/1982 Schulman ................... 128/419 21 Claims, 12 Drawing Sheets

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 US 6,553,263 B1
Page 2

U.S. PATENT DOCUMENTS 5,749,909 A * 5/1998 Schroeppel .................. 607/33

5.948,006 A * 9/1999 Mann ......... ... 607/61
5,065,083 A 11/1991 Owens ........................ 320/13 6,067,474 A 5/2000 Schulman ... 607/57
5,66. A g: Mille - - - - - - 'i. 6,185,454 B1 2/2001 Thompson ..................... 607/2
2- - -a- f ompson. ... 607/ 6,249,703 B1 6/2001 Stanton ....................... 607/30
5,411,537 A * 5/1995 Munshi .............. ... 607/33 6,263,245 B1 * 7/2001 Snell ....... ... 607/60
5,501,703 A 3/1996 Holsheimer et al. ... 407/46 6275.737 B1 8/2001 M 607/61
5,545,191. A * 8/1996 Mann .............. ... 607/57 24 -2 all . . . . . . . . . . . . . . . . . . . . . . . . . .
5,690,693 A 11/1997 Wang et al. ..... ... 607/61
5,733,313 A 3/1998 Barreras, Sr. et al. ........ 607/33 * cited by examiner
U.S. Patent Apr. 22, 2003 Sheet 1 of 12 US 6,553,263 B1

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U.S. Patent Apr. 22, 2003 Sheet 2 of 12 US 6,553,263 B1

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U.S. Patent Apr. 22, 2003 Sheet 4 of 12 US 6,553,263 B1

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U.S. Patent Apr. 22, 2003 Sheet 5 of 12 US 6,553,263 B1
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 US 6,553,263 B1
1 2
IMPLANTABLE PULSE GENERATORS
USING RECHARGEABLE ZERO-VOLT
TECHNOLOGY LITHIUM-ON BATTERIES
This application claims the benefit of U.S. Provisional
Application Ser. No. 60/146,571, filed Jul. 30, 1999, which
application is incorporated herein by reference.
BACKGROUND OF THE INVENTION
The present invention relates generally to implantable
pulse generators, e.g., a pulse generator used within a Spinal
Cord Stimulation (SCS) system or other type of neural
Stimulation System. More particularly, the present invention
relates to the use of a rechargeable Zero-volt technology
lithium-ion battery within Such an implantable pulse gen
erator.
Implantable pulse generators (IPG) are devices that gen
erate electrical Stimuli to body nerves and tissueS for the
therapy of various biological disorders, Such as pacemakers
to treat cardiac arrhythmia, defibrillators to treat cardiac
fibrillation, cochlear Stimulators to treat deafness, retinal
Stimulators to treat blindness, muscle Stimulators to produce
coordinated limb movement, Spinal cord Stimulators to treat
chronic pain, cortical and deep brain Stimulators to treat
motor and psychological disorders, and other neural Stimu
lators to treat urinary incontinence, sleep apnea, shoulder
Sublaxation, etc. The present invention may find applicabil
ity in all Such applications, although the description that
follows will generally focus on the use of the invention
within a Spinal cord Stimulation System. A Spinal cord
Stimulation System is a programmable implantable pulse
generating System used to treat chronic pain by providing
electrical Stimulation pulses from an electrode array placed
epidurally near a patient's Spine. SCS Systems consist of
Several components, including implantable and external
components, Surgical tools, and Software. The present inven
tion provides an Overview an SCS System and emphasizes
the use of a rechargeable Zero volt technology battery within
Such a System, including the charging System used for
charging the rechargeable battery.
Spinal cord Stimulation is a well-accepted clinical method
for reducing pain in certain populations of patients. SCS
Systems typically include an implantable pulse generator,
lead wires, and electrodes connected to the lead wires. The
pulse generator delivers electrical pulses to the dorsal col
umn fibers within the spinal cord through the electrodes
implanted along the dura of the Spinal cord. The attached
lead wires exit the Spinal cord and are tunneled around the
torso of the patient to a Subcutaneous pocket where the pulse
generator is implanted.
Spinal cord and other Stimulation Systems are known in
the art, however, to applicants knowledge, none teach the
use of a rechargeable Zero-volt technology battery within the
implanted portion of the System, with accompanying charg
ing and protection circuitry, as proposed herein. For
example, in U.S. Pat. No. 3,646,940, there is disclosed an
implantable electronic Stimulator that provides timed
Sequenced electrical impulses to a plurality of electrodes So
that only one electrode has a Voltage applied to it at any
given time. Thus, the electrical stimuli provided by the
apparatus taught in the 940 patent comprise Sequential, or
non-overlapping, Stimuli.
In U.S. Pat. No. 3,724,467, an electrode implant is dis
closed for the neural Stimulation of the Spinal cord. A
relatively thin and flexible strip of physiologically inert
plastic is provided with a plurality of electrodes formed
thereon. The electrodes are connected by leads to a RF
receiver, which is also implanted and controlled by an
external controller. The implanted RF receiver has no power
Storage means, and must be coupled to the external control
5 ler in order for neural Stimulation to occur.
In U.S. Pat. No. 3,822,708, another type of electrical
Spinal cord Stimulating device is shown. The device has five
aligned electrodes that are positioned longitudinally on the
Spinal cord and transversely to the nerves entering the Spinal
cord. Current pulses applied to the electrodes are Said to
block Sensed intractable pain, while allowing passage of
other Sensations. The Stimulation pulses applied to the
electrodes are approximately 250 microSeconds in width
with a repetition rate of from 5 to 200 pulses per second. A
15 patient-operable Switch allows the patient to change which
electrodes are activated, i.e., which electrodes receive the
current Stimulus, So that the area between the activated
electrodes on the Spinal cord can be adjusted, as required, to
better block the pain. Other representative patents that show
Spinal cord Stimulation Systems or electrodes include U.S.
Pat. Nos. 4,338,945; 4,379,462; 5,121,754; 5,417,719 and
5,501,703.
The dominant SCS products that are presently commer
cially available attempt to respond to three basic require
ments for Such systems: (1) providing multiple stimulation
electrodes to address variable Stimulation parameter require
ments and multiple sites of electrical Stimulation Signal
delivery; (2) allowing modest to high Stimulation currents
for those patients who need it; and (3) incorporating an
internal power Source with Sufficient energy Storage capacity
to provide Several years of reliable Service to the patient.
Unfortunately, not all of these features are available in any
one device. For example, one known device has a limited
battery life at only modest current outputs, and has only a
35 Single Voltage Source, and hence only a Single Stimulation
channel (programmable Voltage regulated output Source),
which provides a single fixed pattern to up to four electrode
contacts. Another known device offerS higher currents that
can be delivered to the patient, but does not have a battery,
40 and thus requires the patient to wear an external power
Source and controller. Even then, Such device Still has only
one Voltage Source, and hence only a single Stimulation
channel, for delivery of the current Stimulus to multiple
electrodes through a multiplexer. Yet a third known device
45 provides multiple channels of modest current capability, but
does not have an internal power Source, and thus also forces
the patient to wear an external power Source and controller.
It is thus Seen that each of the Systems, or components,
disclosed or described above Suffers from one or more
50 Shortcomings, e.g., no internal power Storage capability, a
Short operating life, none or limited programming features,
large physical size, the need to always wear an external
power Source and controller, the need to use difficult or
unwieldy Surgical techniques and/or tools, unreliable
55 connections, and the like. What is clearly needed, therefore,
is a spinal cord Stimulation System that is Superior to existing
Systems by providing longer life through the use of a
rechargeable battery, easier programming and more Stimu
lating features in a Smaller package without compromising
60 reliability.
Regardless of the application, all implantable pulse gen
erators are active devices requiring energy for operation,
either powered by an implanted battery or an external power
Source. It is desirable for the implantable pulse generator to
65 operate for extended periods of time with little intervention
by the patient or caregiver. However, devices powered by
primary (non-rechargeable) batteries have a finite lifetime
 US 6,553,263 B1
3 4
before the device must be Surgically removed and replaced.
Frequent Surgical replacement is not an acceptable alterna
tive for many patients. If a battery is used as the energy
Source, it must have a large enough Storage capacity to
operate the device for a reasonable length of time. For
low-power devices (less than 100 uW) such as cardiac
pacemakers, a primary battery may operate for a reasonable
length of time, often up to ten years. However, in many
neural Stimulation applications Such as SCS, the power
requirements are considerably greater due to higher Stimu
lation rates, pulse widths, or Stimulation thresholds. Power
ing these devices with conventional primary batteries would
require considerably larger capacity batteries to operate
them for a reasonable length of time, resulting in devices So
large that they may be difficult to implant or, at the very
least, reduce patient comfort. Therefore, in order to maintain
a device size that is conducive to implantation, improved
primary batteries with Significantly higher energy densities
are needed. However, given the State of the art in battery
technology, the required energy density is not achievable at
the present time.
If an implanted battery is not used as the power Source,
then a method is required to transcutaneously Supply power
to the IPG on a continuous basis. For applications that
require large amounts of power Such as heart pumpS and
other heart-assist devices, an external power Source is the
preferred choice. Power can be Supplied to the device via a
percutaneous cable, or more preferably and less invasively,
coupled to the device through electromagnetic induction.
The external power source can be an AC outlet or a DC
battery pack, which may be recharged or replaced with new
batteries when depleted. However, these systems obviously
require the patient to continually wear an external device to
power the implanted pulse generator, which may be unac
ceptable for many patients because they are often bulky and
uncomfortable to wear, and naturally, limit patient mobility.
One alternative power Source is the Secondary, or
rechargeable battery, where the energy in these batteries can
be replenished by recharging the batteries on a periodic
basis. It is known in the art to use a rechargeable battery
within an implant device. See, e.g., U.S. Pat. No. 4,082,097,
entitled “Multimode Recharging System for Living Tissue
Stimulators', and applicant Mann's U.S. patent application
Ser. No. 09/048,826, filed Mar. 25, 1998, entitled “System of
Implantable Devices for Monitoring and/or Affecting Body
Parameters', which patent and patent application are like
wise incorporated herein by reference. The devices and
methods taught in this patent and application, however,
comprise Specialized devices, e.g., microStimulators, or
relate to Specific applications, e.g., cardiac pacing, which
impose unique requirements not applicable to many IPG
applications. Cardiac pacemakers with rechargeable batter
ies have been developed in the past; see U.S. Pat. Nos.
3,454,012; 3,824,129; 3,867,950; 3,888,260; and 4,014,346.
However, these devices were met with limited Success in
regards to battery performance and market acceptance.
Many of these devices were powered by nickel-cadmium
(NiCd) batteries. NiCd's low volumetric energy density of
100 Wh/liter provided limited energy storage, and frequent
charging was required. Also, its low nominal cell Voltage of
1.2 V required many cells to be Stacked in Series, requiring
cells to be closely matched for optimum performance. NiCd
batteries also Suffered from a phenomenon called “memory
effect,” which causes the cell to lose capacity if cycled at
shallow discharge depths. Moreover, NiCd batteries have a
high Self-discharge rate, losing approximately 30% of their
capacity per month at body temperatures. Also, cycle life
performance was poor, as NiCd batteries typically lasted
fewer than 300 cycles. In addition, charging NiCd batteries
was often problematic because the Standard charge termi
nation method for NiCd batteries is somewhat complicated,
requiring the need to detect a Zero or negative Voltage slope
(dV/dt) and/or temperature slope (dT/dt). When NiCd bat
teries are overcharged, an exothermic reaction occurs: Oxy
gen gas given off at the nickel electrode recombines with the
cadmium electrode to form cadmium hydroxide. Cell leak
age or venting can occur as a result of the pressure increase
in the cell. Furthermore, there may be disposal issues with
NiCd batteries, as cadmium is highly toxic to the environ
ment.
Newer battery technologies have been developed in recent
15 years. The Nickel Metal-Hydride (NiMH) battery was
developed to improve upon NiCd performance. NiMH bat
teries were first commercially introduced in 1990, and are in
many ways similar to NiCd batteries. The main exception is
the replacement of the cadmium electrode with a metal
hydride alloy, resulting in more than twice the Volumetric
energy density (>200 Wh/liter). In addition, the metal
hydride is less toxic than cadmium. However, NiMH bat
teries Suffer from Some of the same drawbacks as well,
including low cell voltage (1.2 V), high Self-discharge
25 (>30% per month), difficult charge termination, low cycle
life (<300 cycles), and to a lesser extent, memory effect.
Rechargeable lithium-based batteries were first developed
in the 1970s using lithium metal as the active electrode
material. Lithium has great promise as a battery material
because it is the lightest of all metals, with high cell Voltage
(>3 V) and high energy density. However, lithium metal in
its pure form is extremely reactive, and proved to be very
unstable as a battery electrode as employed in early designs.
In 1990, however, Sony Corporation introduced a safer
35 rechargeable lithium-based battery called lithium-ion (Li
ion), which used a lithium composite oxide (LiCoO) cath
ode and a lithium-intercalating graphite anode. Lithium ions,
or Li", instead of lithium metal, are shuttled back and forth
between the electrodes (hence the nick-name, “rocking
40 chair battery). Lithium-ion is Superior to other rechargeable
battery chemistries, with the highest Volumetric energy
density (>300 Wh/liter) and gravimetric energy density
(>100 Wh/kg). In addition, Lithium-ion batteries have a high
nominal voltage of 3.6 V, as well as low Self-discharge (less
45 than 10% per month), long cycle life (>500), and no memory
effect. Charge termination for Lithium-ion batteries is also
simpler than that of NiCd and NiMH batteries, requiring
only a constant Voltage cutoff. However, Lithium-ion bat
teries are not as tolerant to overcharging and overdischarg
50 ing. If Significantly overcharged, Lithium-ion batteries may
go into “thermal runaway,” a State in which the Voltage is
Sufficiently high to cause the electrode/electrolyte interface
to breakdown and evolve gas, leading to Self-Sustaining
exothermic reactions. As a result, cell leakage or venting can
55 occur. If Lithium-ion batteries are over-discharged (<1 V),
the negative electrode may dissolve and cause plating of the
electrodes. This can lead to internal shorts within the cell, as
well as possible thermal runaway. Therefore, careful moni
toring of the cell Voltage is paramount, and battery protec
60 tion circuitry is necessary to keep the cell in a Safe operating
region.
It is known in the art to use a Lithium-ion battery in an
implantable medical device, See. e.g., U.S. Pat. Nos. 5,411,
537 and 5,690,693. However, such disclosed use requires
65 careful avoidance of overcharge and overdischarging
conditions, as outlined above, else the implant battery, and
hence the implant device, is rendered useless.
 US 6,553,263 B1
S 6
The most recent development in rechargeable battery
technology is the Lithium-ion polymer battery. Lithium-ion
polymer batteries promise higher energy density, lower
Self-discharge and longer cycle life compared to conven
tional aqueous electrolyte Lithium-ion batteries. Its chemi
cal composition is nearly identical to that of conventional
Lithium-ion batteries with the exception of a polymerized
electrolyte in place of the aqueous electrolyte. The polymer
electrolyte enables the battery to be made lighter and thinner
than conventional Lithium-ion batteries by utilizing foil
packaging instead of a metal can, thus allowing it to be
conformable to many form factors. Lithium-ion polymer
batteries are also theoretically Safer Since the polymer elec
trolyte behaves more benignly when overcharged, generat
ing leSS heat and lower internal cell pressure. Unfortunately,
commercial realization of Lithium-ion polymer batteries has
been slow and fraught with early production problems. Only
recently have the major battery manufacturers (Sony,
Panasonic, Sanyo) announced plans for Lithium-ion poly
mer battery production.
What is clearly needed for neural Stimulation applications
is a physically-Small power Source that either provides a
large energy reservoir So that the device may operate over a
Sufficiently length of time, or a replenishable power Source
that Still provides Sufficient energy Storage capacity to allow
operation of the device over relatively long period of time,
and which then provides a convenient, easy and Safe way to
refill the energy reservoir, i.e., recharge the battery, So that
the device r may again operate over a relatively long period
of time before another refilling of the reservoir (recharging
of the battery) is required.
SUMMARY OF THE INVENTION
A spinal cord Stimulation (SCS) System that uses a
rechargeable battery has been invented that is Superior to
existing Systems. Because physically-Small power Sources
Suitable for implantation having Sufficient capacity to power
most neural Stimulation applications do not yet exist, the
power Source used in an neural Stimulation IPG (or other
implantable medical device application) in accordance with
the teachings of the present invention is a rechargeable
battery. More particularly, the present invention is directed
to the use of a rechargeable lithium-ion or lithium-ion
polymer battery within an implantable medical device, Such
as an implantable pulse generator (IPG), coupled with the
use of appropriate battery protection and battery charging
circuits.
In accordance with one aspect of the invention, therefore,
a lithium-ion or lithium-ion polymer rechargeable battery is
used in combination with appropriate battery protection and
charging circuitry housed within an implantable medical
device, e.g., an IPG, of a medical System, e.g., an SCS
System. Such use of a rechargeable battery advantageously
assures the Safe and reliable operation of the System over a
long period of time. While a preferred embodiment of the
invention is represented and described herein by way of a
spinal cord stimulation (SCS) System, it is to be emphasized
that the invention-directed to the use of a lithium-ion or
lithium-ion polymer rechargeable battery in an implanted
medical device, including appropriate battery protection and
battery charging circuitry-may be used within any implant
able medical device.
The representative SCS system with which the lithium
ion based rechargeable battery is employed in accordance
with the present invention provides multiple channels, each
able to produce up to 20 mA of current into a 1 KS2 load. To
provide adequate operating power for Such a System, the
SCS System employs a rechargeable battery and charging/
protection System that allows the patient to operate the
device independent of external power Sources or controllers.
Moreover, the implanted battery is rechargeable using non
invasive means, meaning that the battery can be recharged as
needed when depleted by the patient with minimal incon
Venience. Advantageously, the SCS System herein described
requires only an occasional recharge, is Smaller than existing
implant Systems, has a life of at least 10 years at typical
Settings, offers a simple connection Scheme for detachably
connecting a lead System thereto, and is extremely reliable.
A key element of the SCS system herein described (or
other System employing an implantable pulse generator, or
15 “IPG”) is the use of a rechargeable lithium-ion or lithium
ion polymer battery. Lithium-ion batteries offer several
distinct advantages over other battery chemistries: high
Volumetric and gravimetric energy densities, high cell
Voltage, long cycle life, Simple detection of charge
termination, low toxicity, and no memory effect.
The lithium-ion or lithium-ion polymer battery used in the
SCS system described herein is specifically designed for
implantable medical devices. It incorporates Several distinct
features compared to conventional lithium-ion batteries. The
25 battery case is made from a high-resistivity Titanium alloy
to reduce heating from eddy currents induced from the
electromagnetic field produced by inductive charging. The
case is also hermetically-Sealed to increase cycle life and
shelf life performance. Most importantly, the battery is
Specifically designed to allow discharge to Zero Volts with
out Suffering irreversible damage, which feature is referred
to herein as “Zero-volt technology'. This feature is signifi
cant because conventional lithium-ion batteries can not
operate at low voltages (less than about 1 V) without damage
35 occurring to the negative electrode. Thus, Should an implant
device with a conventional lithium-ion battery be operated
until the implanted battery is nearly discharged (~2.5 V), and
if the battery is not Subsequently recharged for any one of
many reasons, the battery will naturally Self-discharge to
40 below 1 V in less than six months. If this occurs, the
performance and Safety of the cell may be compromised. In
contrast, the present invention relates to an implantable
electrical Stimulator capable of recharging its lithium-ion
battery from an electrical potential of 0 V up to normal
45 operating Voltages, e.g., approximately 4 V. The invention
takes advantage of new battery technology that allows
discharge down to 0 V without damage to the cell.
In accordance with one aspect of the present invention,
the SCS System utilizes a non-invasive, electromagnetic
50 induction System to couple the energy from an external
power Source to the implanted charging circuitry for
recharging the battery. The charging circuitry contains a
charge controller that converts the unregulated induced
power into the proper charging current. The level of the
55 charging current is determined by a State machine-type
algorithm that monitors the voltage level of the battery. In
one embodiment, when the battery voltage is below 1 V, for
example, the battery is charged with a very low current of
C/50 (1/50 of the battery capacity) or less. When the battery
60 Voltage Surpasses 1 V, the battery is charged at a rate of
approximately C/25. When the battery voltage surpasses 2.5
V, the battery is charged at the maximum charge rate of
approximately C/2, until the battery Voltage nears its desired
full-charge Voltage, at which point the charge rate may again
65 be reduced. That is, fast charging occurs at the Safer lower
battery voltages (e.g., voltage above about 2.5 V), and
slower charging occurs when the battery nearS full charge
 US 6,553,263 B1
7 8
higher battery voltages (above about 4.0 V). When poten
tially less-than-safe very low voltages are encountered (e.g.,
less than 2.5 V), then very slow (trickle) charging occurs to
bring the battery Voltage back up to the Safer Voltage levels
where more rapid charging can safely occur. This multi-rate
charge algorithm minimizes charging time while ensuring
the cell is safely charged. The charging circuitry also con
tains a battery protection circuit that continuously monitors
the battery voltage and current. If the battery operates
outside of a predetermined range of Voltage or current, the
battery protection circuitry disconnects the battery from the
particular fault, i.e. charging circuitry or load circuits.
Moreover, the charging circuitry is able to monitor the
State-of-charge of the battery by measuring the Voltage of the
battery, Since there is good correlation between battery
Voltage and State of charge in lithium-ion batteries.
In accordance with another aspect of the invention, an
external charging System is provided that Supplies the energy
to the rechargeable battery of the IPG device. Such external
charging System may take one of Several forms or embodi
ments. In one embodiment, the external charger is powered
by an alternating current (AC) power Supply and is manually
controlled by the patient. In another embodiment, the exter
nal charger is powered by an AC power Supply and is
automatically controlled by the external controller for the
implanted device. Such embodiment necessarily employs a
Suitable communication link between the external controller
and the external charger, the communication link
comprising, e.g., a cable (hard wire connection), an infrared
(IR) link, or a radio frequency (RF) link. In another preferred
embodiment, the external charger is itself powered by a
battery, which battery may be a replaceable (primary)
battery, or a rechargeable battery.
The external charger may thus assume one of Several
forms, ranging from a table-top AC powered device to a
Small portable (mobile) device that uses a primary or Sec
ondary battery to transfer energy to the implanted device. In
all instances, the electrical circuitry within the implanted
device has final control upon the acceptance or rejection of
incoming energy. The external charging System, however, is
optimally controlled So that its operation is terminated if the
implanted device does not require the external energy.
In operation, the SCS System (or other System employing
an IPG) monitors the state of charge of the internal battery
and controls the charging process. Then, through a Suitable
communication link, the SCS system is able to inform the
patient or clinician regarding the Status of the System,
including the State of charge, and makes requests to initiate
an external charge process. In this manner, the acceptance of
energy from the external charger is entirely under the control
of the implant circuitry, e.g., the IPG, and Several layers of
physical and Software control may be used, as desired or
needed, to ensure reliable and Safe operation of the charging
process. The use of Such a rechargeable power Source thus
greatly extends the useful life of the SCS system, or other
IPG systems. This means that once the IPG is implanted, it
can, under normal conditions, operate for many years with
out having to be explanted.
All of the above and other features combine to provide a
SCS system employing an IPG or similar implantable elec
trical stimulator (or other implantable electrical circuitry,
Such as an implantable Sensor) having a rechargeable battery
that is markedly improved over what has heretofore been
available.
BRIEF DESCRIPTION OF THE DRAWINGS
The above and other aspects, features and advantages of
the present invention will be more apparent from the fol
lowing more particular description thereof, presented in
conjunction with the following drawings wherein:
FIG. 1 is a block diagram that illustrates the various
implantable, external, and Surgical components of an SCS
System that employs an implantable pulse generator (IPG)
having a rechargeable battery in accordance with the present
invention;
FIG. 2 shows various components of the SCS system of
FIG. 1;
FIG. 3 is a block diagram that illustrates the main
components, including a rechargeable battery, of one
embodiment of an implantable pulse generator (IPG) used
with the invention;
15 FIG. 4 is a block diagram that illustrates another embodi
ment of an implantable pulse generator (IPG) that may be
used with the invention;
FIG. 5 shows a representative screen on a handheld
patient programmer that may be used with the invention;
FIG. 6 illustrates the external components of a represen
tative portable charging System used by the invention;
FIG. 7A shows a block diagram of the battery charging
System used with the invention;
25 FIG. 7B is a functional block diagram of the preferred
misalignment and charge complete indicators used with the
invention;
FIG. 8 is a State diagram illustrating the various States that
may be assumed by the implant battery charging circuitry
during operation of the charging System;
FIG. 9 shows a block diagram of the battery charger/
protection circuitry utilized within the external charging
Station of the invention;
FIG. 10A depicts a sectional view of a preferred structure
35 of a zero-volt technology lithium-ion battery usable with the
invention; and
FIG. 10B depicts the battery voltage versus time when the
lithium-Ion battery of FIG. 10A has been discharged to zero
Volts and is recharged using the recharging circuitry of the
40
present invention.
Corresponding reference characters indicate correspond
ing components throughout the Several views of the draw
ings.
45 DETAILED DESCRIPTION OF THE
INVENTION
The following description is of the best mode presently
contemplated for carrying out the invention. This descrip
50 tion is not to be taken in a limiting Sense, but is made merely
for the purpose of describing the general principles of the
invention. The scope of the invention should be determined
with reference to the claims.
At the outset, it is noted that the present invention may be
55 used with an implantable pulse generator (IPG), or similar
electrical Stimulator and/or electrical Sensor, that may be
used as a component of numerous different types of Stimu
lation Systems. The description that follows relates to use of
the invention within a spinal cord stimulation (SCS) system.
60 However, it is to be understood that the invention is not so
limited. Rather, the invention may be used with any type of
implantable electrical circuitry that could benefit from deriv
ing its operating power from a rechargeable battery.
Further, while the invention is described in connection
65 with its use within an SCS system, it is noted that a complete
description of the SCS system is not provided herein. Rather,
only those portions of the SCS system that relate directly to
 US 6,553,263 B1
9 10
the present invention are disclosed. A more complete
description of the SCS System may be found in copending
U.S. patent application Ser. No. 09/626,010, filed Jul. 26,
2000, which application is incorporated herein by reference.
Turning first to FIG. 1, a block diagram is shown that
illustrates the various components of an SCS System
wherein the invention may be used. These components may
be subdivided into three broad categories: (1) implantable
components 10, (2) external components 20, and (3) Surgical
components 30. As seen in FIG. 1, the implantable compo
nents 10 include an implantable pulse generator (IPG) 100,
an electrode array 110, and (as needed) a lead extension 120.
The extension 120 is used to electrically connect the elec
trode array 110 to the IPG 100. In a preferred embodiment,
the IPG 100, described more fully below in connection with
FIGS. 4 or 5, comprises a rechargeable, multichannel, 16
contact, telemetry-controlled, pulse generator housed in a
rounded high-resistivity titanium alloy case to reduce eddy
current heating during the inductive charging process. The
preferred embodiment includes 16 current Sources, each
with a programmable amplitude Such that the device is a
current-regulated, rather than a Voltage-regulated System.
Four pulse timing generators are used to create 4 indepen
dent groups in which any of 16 electrodes can be included
in a positive or negative polarity. A connector that forms an
integral part of the IPG 100 allows the electrode array 110
or extension 120 to be detachably Secured, i.e., electrically
connected, to the IPG 100. This connector may be of the type
described in U.S. patent application Ser. No. 09/239,926,
filed Jan. 28, 1999, incorporated herein by reference.
The IPG 100 contains stimulating electrical circuitry
("stimulating electronics’), a power Source, e.g.,a recharge
able battery, and a telemetry system. Typically, the IPG 100
is placed in a Surgically-made pocket either in the abdomen,
or just at the top of the buttocks. It may, of course, also be
implanted in other locations of the patient's body. Once
implanted, the IPG 100 is connected to the lead system,
comprising the lead extension 120, if needed, and the
electrode array 110. The lead extension 120, for example,
may be tunneled up to the Spinal column. Once implanted,
the lead system 110 and lead extension 120 are intended to
be permanent. In contrast, the IPG 100 may be replaced
when its power Source fails or is no longer rechargeable.
Advantageously, the IPG 100 can provide electrical
Stimulation through a multiplicity of electrodes, e.g., Sixteen
electrodes, included within the electrode array 110.
AS seen best in FIG. 2, and as also illustrated in FIG. 1,
the electrode array 110 and its associated lead System
typically interface with the implantable pulse generator
(IPG) 100 via a lead extension system 120. The electrode
array 110 may also be connect to an external trial Stimulator
140, through the use of a percutaneous lead extension 132
and/or an external cable 134. The external trail stimulator
140 includes the same pulse generation circuitry as does the
IPG 100, and is used on a trial basis for, e.g., 7-10 days after
the electrode array has been implanted, prior to implantation
of the IPG 100, in order to test the effectiveness of the
stimulation that is to be provided.
Still with reference to FIG. 2 and FIG. 1, the hand-held
programmer (HHP) 202 may be used to control the IPG 100
via a Suitable non-invasive communications link 203, e.g.,
an RF link. Such control allows the IPG 100 to be turned ON
or OFF, and generally allows Stimulation parameters, e.g.,
pulse amplitude, width, and rate, to be set within prescribed
limits. The HHP may also be linked with the external trial
stimulator 140 through another link 205', e.g., an infra red
link. Detailed programming of the IPG 100 is preferably
accomplished through the use of an external clinician's
programmer 204 (FIG. 1) which is coupled to the IPG 100
through the HHP 202. An external charger 208, non
invasively coupled with the IPG 100 through link 209, e.g.,
an inductive link, allows energy Stored or otherwise made
available to the charger 208 to be coupled into the recharge
able battery housed within the IPG 100.
Turning next to FIG. 3, a block diagram is shown that
illustrates the main components of one embodiment of an
implantable pulse generator (IPG) 100 that may be used with
the invention. As seen in FIG. 3, the IPG includes a
microcontroller (uC) 160 connected to memory circuitry
162. The uC 160 typically comprises a microprocessor and
15 asSociated logic circuitry, which in combination with control
logic circuits 166, timer logic 168, and an oscillator and
clock circuit 164, generate the necessary control and Status
Signals which allow the uC to control the operation of the
IPG in accordance with a Selected operating program and
Stimulation parameters. The operating program and Stimu
lation parameters are typically Stored within the memory
162 by transmitting an appropriate modulated carrier Signal
through a receiving coil 170 and charging and forward
telemetry circuitry 172 from an external programming unit,
25 e.g., a handheld programmer 202 and/or a clinician pro
grammer 204, assisted as required through the use of a
directional device 206 (see FIG. 1). (The handheld program
mer is thus considered to be in “telecommunicative' contact
with the IPG, and the clinician programmer is likewise
considered to be in telecommunicative contact with the
handheld programmer, and through the handheld
programmer, with the IPG.) The charging and forward
telemetry circuitry 172 demodulates the carrier Signal it
receives through the coil 170 to recover the programming
35 data, e.g., the operating program and/or the Stimulation
parameters, which programming data is then Stored within
the memory 162, or within other memory elements (not
shown) distributed throughout the IPG 100.
The microcontroller 160 is further coupled to monitoring
40 circuits 174 via bus 173. The monitoring circuits 174
monitor the status of various nodes or other points 175
throughout the IPG 100, e.g., power Supply Voltages, current
values, temperature, the impedance of electrodes attached to
the various electrodes E1 ... En, and the like. Informational
45 data Sensed through the monitoring circuit 174 may be sent
to a remote location external to the IPG (e.g., a non
implanted location) through back telemetry circuitry 176,
including a transmission coil 177.
The operating power for the IPG 100 is derived from a
50 rechargeable power source 180. In accordance with the
teachings of the present invention, Such rechargeable power
Source 180 comprises a lithium-ion or lithium-ion polymer
battery. The advantages of using Such batteries have been
previously discussed. The rechargeable battery 180 provides
55 an unregulated Voltage to power circuits 182. The power
circuits 182, in turn, generate the various Voltages 184, Some
of which are regulated and Some of which are not, as needed
by the various circuits located within the IPG. A particular
feature of the present invention is the manner in which
60 recharging occurs, on an as-needed basis, and wherein the
power circuits 182 control the charging operation So that
only energy that is needed is allowed to charge the battery,
thereby preventing overcharging from occurring.
As indicated previously, the power source 180 of the IPG
65 100 comprises a rechargeable lithium-ion or lithium-ion
polymer battery. Recharging occurs inductively from an
external charger (shown below in FIGS. 7 and 9) to an
 US 6,553,263 B1
11
implant depth of approximately 2 to 3 cm. For Safety
reasons, only authorized charging devices may be used to
recharge the battery. The battery is chargeable to 80% of its
capacity within two hours. Moreover, at an 80% charge, a
Single battery discharge is able to Support Stimulation at
typical parameter Settings on one channel (electrode group)
for at least about three weeks, and on 4 channels for
approximately one week, after 10 years of cycling.
Additionally, the IPG 100 is able to monitor and telemeter
the status of its rechargeable battery 180 each time a
communication link is established with the external patient
programmer 202. Typically, a telecommunicative link is
established, and hence battery monitoring may occur, each
time a programming event occurs, i.e., each time the patient
or medical perSonnel change a Stimulus parameter.
AS described, it is thus seen that any of the n electrodes
may be assigned to up to k possible groups (where k is an
integer corresponding to the number of channels, and in a
preferred embodiment is equal to 4). Moreover, any of the n
electrodes can operate, or be included in, any of the k
channels. The channel identifies which electrodes are
Selected to Synchronously Source or Sink current in order to
create an electric field. Amplitudes and polarities of elec
trodes on a channel may vary, e.g., as controlled by the
patient hand held programmer 202. External programming
Software in the clinician programmer 204 is typically used to
Set parameters including electrode polarity, amplitude, pulse
rate and pulse width for the electrodes of a given channel,
among other possible programmable features.
Hence, it is seen that each of the n programmable elec
trode contacts can be programmed to have a positive
(Sourcing current), negative (sinking current), or off (no
current) polarity in any of the k channels. Moreover, it is
Seen that each of the n electrode contacts can operate in a
bipolar mode or multipolar mode, e.g., where two or more
electrode contacts are grouped to Source/sink current at the
Same time. Alternatively, each of the n electrode contacts can
operate in a monopolar mode where, e.g., the electrode
contacts associated with a channel are configured as cath
odes (negative), and the case electrode, on the IPG case, is
configured as an anode (positive).
Further, in the preferred embodiment, the amplitude of the
current pulse being Sourced or Sunk from a given electrode
contact may be programmed to one of Several discrete
current levels, e.g. i0 to t10 mA, in Steps of 0.1 mA. Also,
in the preferred embodiment, the pulse width of the current
pulses is adjustable in convenient increments. For example,
the pulse width range is preferably at least 0 to 1 millisec
onds (ms) in increments of 10 microSeconds (us). Similarly,
in the preferred embodiment, the pulse rate is adjustable
within acceptable limits. For example, the pulse rate pref
erably spans 0-1000 Hz. Other programmable features can
include slow Start/end ramping, burst Stimulation cycling
(on for X time, off for Y time), and open or closed loop
Sensing modes.
The stimulation pulses generated by the IPG 100 are
charged balanced. This means that the amount of positive
charge associated with a given Stimulus pulse must be offset
with an equal and opposite negative charge. Charge balance
may be achieved through a coupling capacitor, which pro
vides a passive capacitor discharge that achieves the desired
charge balanced condition. Alternatively, active biphasic or
multi-phasic pulses with positive and negative phases that
are balanced may be used to achieve the needed charge
balanced condition.
The type of bidirectional current sources depicted in FIG.
3 may be realized by those of skill in the art using the
12
teachings of U.S. patent application Ser. No. 09/338,700,
filed Jun. 23, 1999, entitled “Programmable Current Output
Stimulus Stage for Implantable Device', which application
is incorporated herein by reference.
5 Advantageously, by using current Sources of the type
disclosed in the referenced patent application, or equivalent,
the IPG 100 is able to individually control the n electrode
contacts associated with the n electrode nodes E1, E2,
E3, . . . En. Controlling the current Sources and Switching
matrix 188 using the microcontroller 160, in combination
with the control logic 166 and timer logic 168, thereby
allows each electrode contact to be paired or grouped with
other electrode contacts, including the monopolar case
electrode, in order to control the polarity, amplitude, rate,
15 pulse width and channel through which the current Stimulus
pulses are provided. Other output circuits can be used with
the invention, including Voltage regulated output, multi
plexed channels, and the like.
As shown in FIG. 3, much of circuitry included within the
IPG 100 may be realized on a single application specific
integrated circuit (ASIC) 190. This allows the overall size of
the IPG 100 to be quite small, and readily housed within a
suitable hermetically-sealed case. The IPG 100 includes n
25
feedthroughs to allow electrical contact to be individually
made from inside of the hermetically-Sealed case with the n
electrodes that form part of the lead system outside of the
case. The IPG case is preferably made from titanium and is
shaped in a rounded case, as illustrated, e.g., in FIG. 2. The
rounded IPG case has a maximum circular diameter D of
about 50 mm, and preferably only about 45 mm (or equiva
lent area). The implant case has Smooth curved transitions
that minimize or eliminate edges or Sharp corners. The
maximum thickness W of the case is about 10 mm. Other
35
materials, e.g. ceramic, can be used that provide leSS Shield
ing between the recharging coils, and thus improving effi
ciency.
It is thus seen that the implant portion 10 of the SCS
system of the present invention (see FIG. 1) includes an
40 implantable pulse generator (IPG) 100 with a rechargeable
battery 180 as described in FIG. 4. Such IPG further includes
Stimulating electronics (comprising programmable current
Sources and a Switching matrix and associated control logic),
and a telemetry System. Advantageously, the rechargeable
45
battery 180 may be recharged repeatedly as needed.
In use, the IPG 100 is placed in a surgically-made pocket
either in the abdomen, or just at the top of the buttocks, and
detachably connected to the lead System (comprising lead
extension 120 and electrode array 110). While the lead
50 System is intended to be permanent, the IPG may be replaced
should its power Source fail, or for other reasons. Thus, a
Suitable connector, e.g., the Snap-on tool-leSS connector
disclosed in U.S. patent application Ser. No. 09/239,926,
filed Jan. 28, 1999, or other suitable connectors, may advan
55 tageously be used to make the connection between the lead
system and the IPG 100. This 926 patent application is
incorporated herein by reference.
Once the IPG 100 has been implanted, and the implant
System 10 is in place, the System is programmed to provide
60 a desired Stimulation pattern at desired times of the day. The
Stimulation parameters that can be programmed include the
number of channels (defined by the selection of electrodes
with Synchronized stimulation), the Stimulation rate and the
Stimulation pulse width. The current output from each
65 electrode is defined by polarity and amplitude.
The back telemetry features of the IPG 100 allow the
status of the IPG to be checked. For example, when the
 US 6,553,263 B1
13
external hand-held programmer 202 (and/or the clinician
programmer 204), initiates a programming Session with the
implant system 10 (FIG. 1), the capacity of the battery is
telemetered So that the external programmer can calculate
the estimated time to recharge. Any changes made to the
current Stimulus parameters are confirmed through back
telemetry, thereby assuring that Such changes have been
correctly received and implemented within the implant
System. Moreover, upon interrogation by the external
programmer, all programmable Settings Stored within the
implant System 10 may be uploaded to one or more external
programmerS.
Turning next to FIG. 4, a hybrid block diagram of an
alternative embodiment of an IPG 100' that may be used
with the invention is illustrated. The IPG 100' includes both
analog and digital dies, or integrated circuits (ICS), housed
in a single hermetically-Sealed rounded case having a diam
eter of about 45 mm and a maximum thickness of about 10
mm. Many of the circuits contained within the IPG 100" are
identical or similar to the circuits contained within the IPG
100, shown in FIG.3. The IPG 100' includes a processor die,
or chip, 160', an RF telemetry circuit 172 (typically realized
with discrete components), a charger coil 171", a lithium ion
or lithium ion polymer battery 180, battery charger and
protection circuits 182", memory circuits 162 (SEEROM)
and 163' (SRAM), a digital IC 191', an analog IC 190', and
a capacitor array and header connector 192'.
The capacitor array and header connector 192' includes 16
output decoupling capacitors, as well as respective feed
through connectors for connecting one Side of each decou
pling capacitor through the hermetically-Sealed case to a
connector to which the electrode array 110, or lead extension
120, may be detachably connected.
The processor 160' is realized with an application specific
integrated circuit (ASIC) that comprises the main device for
full bi-directional communication and programming. The
processor 160' utilizes a 8086 core (the 8086 is a
commercially-available microprocessor available from, e.g.,
Intel, or a low power equivalent thereof, 16 kilobytes of
SRAM memory, two Synchronous Serial interface circuits, a
serial EEPROM interface, and a ROM bootloader 735. The
processor die 160' further includes an efficient clock oscil
lator circuit 164' and a mixer and modulator/demodulator
circuit implementing the QFAST RF telemetry method Sup
porting bidirectional telemetry at 8 Kbits/second. QFAST
Stands for “Ouadrature Fast Acquisition Spread Spectrum
Technique', and represents a known and viable approach for
modulating and demodulating data. The QFAST RF telem
etry method is further disclosed in U.S. Pat. No. 5,559,828,
incorporated herein by reference. An analog-to-digital con
verter (A/D) circuit 734 is also resident on the processor 160'
to allow monitoring of various System level analog signals,
impedances, regulator Status and battery Voltage. In the
preferred embodiment, the A/D converter circuit 734 com
prises a twelve-bit A/D converter. The processor 160' further
includes the necessary communication links to other indi
vidual ASIC's utilized within the IPG 100'. The processor
160', like all Similar processors, operates in accordance with
a program that is Stored within its memory circuits.
The analog IC (AIC) 190 comprises an ASIC that func
tions as the main integrated circuit that performs Several
tasks necessary for the functionality of the IPG 100', includ
ing providing power regulation, Stimulus output, and imped
ance measurement and monitoring. Electronic circuitry 194'
performs the impedance measurement and monitoring func
tion. The main area of the analog 190" is devoted to the
current stimulus generators 186". These generators 186" may
14
be realized using the circuitry described in the previously
referenced patent application, or Similar circuitry. These
generators 186" are designed to deliver up to 20 mA aggre
gate and up to 12.7 mA on a single channel in 0.1 mA Steps,
which resolution requires that a Seven (7) bit digital-to
analog (DAC) circuit be employed at the output current
DAC 186". Regulators for the IPG 100' supply the processor
and the digital sequencer with a voltage of 2.7 V+10%.
Digital interface circuits residing on the AIC 190' are
similarly supplied with a voltage of 2.7 V+10%. A regulator
programmable from 5V to 18V supplies the operating volt
age for the output current DACs 186". The output current
Sources on the analog IC thus include Sixteen bidirectional
output current Sources, each configured to operate as a baC
15
current Source. Each DAC output current Source may Source
or Sink current, i.e., each DAC output current Source is
bidirectional. Each DAC output current Source is connected
to an electrode node. Each electrode node, in turn, is
connected to a coupling capacitor Cn. The coupling capaci
tors Cn and electrode nodes, as well as the remaining
circuitry on the analog IC 186', are all housed within the
hermetically sealed case of the IPG 100. A feedthrough pin,
which is included as part of the header connector 192',
allows electrical connection to be made between each of the
coupling capacitors Cn and the respective electrodes E1, E2,
25 E3, ..., or E 16, to which the DAC output current source is
asSociated.
The digital IC (DigiC) 191' functions as the primary
interface between the processor 160' and the AIC output
circuits 186". The main function of the DigIC 191' is to
provide Stimulus information to the output current generator
register banks. The DigiC 191" thus controls and changes the
Stimulus levels and Sequences when prompted by the pro
cessor 160'. In a preferred embodiment, the DigiC 191'
comprises a digital application Specific integrated circuit
35 (digital ASIC).
The RF circuitry 172' includes antennas and preamplifiers
that receive signals from the HHP 202 and provide an
interface at adequate levels for the demodulation/
modulation of the communication frames used in the pro
40 cessor 160'. Any suitable carrier frequency may be used for
Such communications. In a preferred embodiment, the fre
quency of the RF carrier Signal used for Such communica
tions is 262.144 KHZ, or approximately 262 KHZ. A trans
mitter Section receives digital transmit Signals from the
45 quadrature components, TXI and TXQ, of the data as gen
erated on the 262 KHZ carrier. The TXI and TxQ signals are
coupled directly into the antenna during transmit.
Additionally, the transmit Section couples the antenna to the
receiver during a receive mode. The transmitter Section is
50 responsible for antenna tunning and coupling while mini
mizing the processor noise to the RF signal. AppendiX B
contains additional information regarding the RF commu
nications that occur between the IPG and external devices,
e.g., the handheld programmer 202.
55 A receiver portion of the RF circuitry 172 receives an
incoming RF signal through a coupling circuit, amplifies the
Signal, and delivers it to a mixer located inside of the
processor 160'.
The RF circuitry 172' also includes an antenna. The
60 antenna, in a preferred embodiment, comprises a ferrite rod
located in an epoxy header of the IPG case. The antenna
makes electrical connection to the IPG circuitry via two
feedthrough pins included within the header connector 192
(the other pins providing electrical connection to the indi
65 vidual electrodes located in the electrode array 110).
The Battery Charger and Protection Circuits 182 provide
battery charging and protection functions for the Lithium
 US 6,553,263 B1
15
Ion battery 180. A charger coil 171" inductively (i.e.,
electromagnetically) receives rf energy from the external
charging station. The battery 180 preferably has a 720
mWHr capacity. The preferred battery 180 has a life of 500
cycles over 10 years with no more than 80% loss in capacity.
The battery charger circuits perform three main functions:
(1) during normal operation, they continually monitor the
battery Voltage and provide charge Status information to the
patient at the onset of a communication link, (2) they ensure
that the battery is not over-discharged, and (3) they monitor
the battery voltage during a charging cycle to ensure that the
battery does not experience overcharging. These functions
are explained in more detail below in conjunction with
FIGS. 7, 8 and 9.
Next, a representation of one embodiment of the HHP202
is shown in FIG. 5. As seen in FIG. 5, the HHP includes a
lighted display screen 240 and a button pad 241 that includes
a series of buttons 242, 243, 244 and 245. (The number of
buttons shown in FIG. 5 is exemplary only; any number of
buttons may be employed.) The buttons provided within the
button pad 241 allow the IPG to be tuned ON or OFF,
provide for the adjustment or Setting of up to three param
eters at any given time, and provide for the Selection
between channels or Screens. Some functions or Screens may
be accessible by pressing particular buttons in combination
or for extended periods of time. In a preferred embodiment,
the Screen 240 is realized using a dot matrix type graphics
display with 55 rows and 128 columns.
The button pad 241, in a preferred embodiment, com
prises a membrane Switch with metal domes positioned over
a flex circuit, which bonds to the top housing of the HHP. A
keypad connector connects directly a printed circuit board
(PCB) of the HHP, and the bonding to the housing seals the
connector opening.
In a preferred embodiment, the patient handheld program
mer 202 is turned ON by pressing any button, and is
automatically turned OFF after a designated duration of
disuse, e.g., 1 minute. One of the buttons, e.g., the IPG
button 242, functions as an ON-OFF button for immediate
access to turn the IPG on and off. When the IPG is turned
ON, all channels are turned on to their last settings. If slow
Start/end is enabled, the Stimulation intensity is ramped up
gradually when the IPG (or ETS) is first turned ON with the
HHP. When the IPG is turned OFF, all channels are turned
off. If slow start/end is enabled, the stimulation intensity
may be ramped down gradually rather than abruptly turned
off. Another of the buttons, e.g., the SEL button 243,
functions as a “select” button that allows the handheld
programmer to Switch between Screen displays and/or
parameters. Up/down buttons 244 and 245 provide imme
diate access to any of three parameters, e.g., amplitude,
pulse width, and rate.
Also included on the screens shown on the display 240 of
the handheld programmer 202 are status icons or other
informational displayS. A battery recharge countdown num
ber 246 shows the estimated time left before the battery of
the IPG needs to be recharged. A battery status icon 248
further shows or displays the estimated implant battery
capacity. This icon flashes (or otherwise changes in Some
fashion) in order to alert the users when a low battery
condition is Sensed. Every time the patient programmer is
activated to program or turn on the IPG, the actual battery
Status of the implanted pulse generator (IPG) is interrogated
and retrieved by telemetry to reconcile actual verses esti
mated battery capacity. Other status icons 250 are provided
that display the Status of the patient-programmer-to-implant
link and the patient-programmer-to-clinician-programmer
link.
16
AS a Safety feature, the physician may lock out or Set
Selectable parameter ranges via the fitting Station to prevent
the patient from accessing undesirable settings (i.e., a lock
out range). Typically, locked parameters are dropped from
the Screen display.
The main Screen displayed by default upon activation of
the handheld programmer 202 shows amplitude and rate by
channel, as illustrated in FIG. 5. As shown in FIG. 5, the
display is for channel 1, the amplitude is 7.2 ma, and the rate
is 100 pps. Thus, it is seen that the channel number (or
abbreviated channel name as Set by the clinician
programmer) is displayed on the Screen with the parameters.
Amplitude is the preferred default Selection (i.e., it is the
15
parameter that is displayed when the unit is first turned ON).
Whenever a displayed parameter is changed, the Settings
of the IPG 100 are changed via telemetry to reflect the
change. However, in order to assure that the IPG has
received the telemetry Signal and made the corresponding
change without a discrepancy between the IPG and the value
displayed, a back telemetry response must be received from
the IPG before the screen value changes. Only the param
eters that have not been locked out from the clinicians
programming Station are adjustable. Further, only those
channels that have electrodes programmed for Stimulation
25
are Selectable.
Turning next to FIG. 6, the external components of a
representative portable charging System used with the inven
tion are illustrated. The recharging System is used to trans
cutaneously recharge the implant battery 180 of the IPG 100
as needed, via inductive coupling. Recharging typically
occurs at a rate of approximately C/2 (current equal to
one-half battery capacity). In order to recharge the battery
from a completely discharged State to 80% capacity,
35 approximately two hours recharge time is required. Because
of this time, a portable charger System is preferred. Hence,
as Seen in FIG. 8, a two part System is preferred comprising
a portable charger 208 and a base station 210. The base
station 210 is connected to an AC plug 211, and may thus be
40 easily plugged into any standard 110 VAC outlet. The
portable charger 208 includes recharging circuitry housed
within a housing 270 that may be detachably inserted into
the charging port 210 in order to be recharged. Thus, both
the IPG 100 and the portable charger 208 are rechargeable.
45 The housing 270 is returned to the charging port 210
between uses.
For the “Package B' embodiment shown in FIG. 6, a
charging head 272 is connected to the recharging circuitry
270 by way of a suitable flexible cable 274. When the IPG
50 battery needs to be recharged, a disposable adhesive pouch
276, double sided adhesive, or a Velcro(R) strip is placed on
the patient's skin, over the location where the IPG is
implanted. For patients with adhesive allergies, a flexible
belt with an attachment means for the charger is provided
55 Such that the patient can Secure the charger over the implant.
The charging head 272 is then simply Slid into the pouch,
adhered to the adhesive, or fastened to the Strip, So that it is
within 2-3 cm of the IPG 100.
In order for efficient transfer of energy to the IPG, it is
60 important that the head 272 (or more particularly, the coil
within the head 272) be properly aligned with the IPG. Thus,
in a preferred embodiment, a Speaker generates an audio
tone when the two devices are not aligned, or misaligned.
The misalignment indicator is activated by Sensing a change
65 in the charge coil Voltage, which reflects a change in the
reflected impedance, as discussed in more detail below.
When the coil voltage is greater than a predetermined value,
 US 6,553,263 B1
17
a beeping or other audible tone and/or visual indicator is
activated. When the coil voltage drops below this value, the
beeping or tone or visual indicator turns off. The advantage
of Such a feature is that should the device move out of range
of the implant (more likely with a non-adhesive attachment
mechanism), the misalignment indicator is activated result
ing in a beeping Sound or other recognizable indicator So that
the patient is immediately informed to readjust the position
of the charging device. A misalignment indicator may also
be implemented in Visual form, Such as a light emitting
diode (LED).
The external charging device also has a State of charge
indicator, i.e. an LED, or an audio tone, to indicate when the
external battery is fully charged. This feature can also be
included in a primary battery operated charger, So that a new
battery is required for each charge Session. When charging
the implant, the charger battery would be depleted. A charge
completion indicator is also provided Such that when the
charger battery is nearly depleted, a distinct tone is gener
ated to alert the user. Also, back-telemetry with the IPG
allows the charging process to be monitored. When the
implant battery is fully charged, a signal will be communi
cated from the implant to the charger, and a distinct audio
tone will be generated to alert the user.
An alternative embodiment of the portable charger 208
includes the recharging circuitry and battery and charging
head housed within a single round or oval shaped package
272, as also shown in FIG. 6 (labeled “Package A”). Such
package is approximately three inches in diameter and is
comfortable to hold against the skin. The adhesive pouch
276 need not necessarily comprise a pouch, but may utilize
any Suitable means for holding the head (coil) of the charger
208 in proper alignment with the IPG, such as Velcro(R) strips
or adhesive patches.
Turning next to FIG. 7A, a block diagram of the recharg
ing elements of the invention is illustrated. As shown in FIG.
7A, (and as also evident in FIGS. 3 and 4), the IPG 100 is
implanted under the patient’s skin 278. The IPG includes a
replenishable power Source 180, Such as a rechargeable
battery. It is this replenishable power source that must be
replenished or recharged on a regular basis, or as needed, So
that the IPG 100 can carry out its intended function. To that
end, the recharging System of the present invention uses the
portable external charger 208 to couple energy, represented
in FIG. 7A by the wavy arrow 290, into the IPG’s power
Source 180. The portable external charger 208, in turn,
obtains the energy 290 that it couples into the power source
180 from its own battery 277.
The battery 277 in the charger 208, in the preferred
embodiment, comprises a rechargeable battery, preferably a
Lithium-Ion battery or a lithium-ion polymer battery.
(Alternatively, the battery 277 may comprise a replaceable
battery.) When a recharge is needed, energy 293 is coupled
to the battery 277 via the charging base station 210 in
conventional manner. The charging base Station 210, in turn,
receives the energy it couples to the battery 277 from an AC
power line 211. A power amplifier 275, included within the
portable charger 208, enables the transfer of energy from the
battery 277 to the implant power source 180. Such circuitry
275 essentially comprises DC-to-AC conversion circuitry
that converts dc power from the battery 277 to an ac signal
that may be inductively coupled through a coil 279 located
in the external charging head 272 (or within the round case
272, see FIG. 6) with another coil 680 included within the
IPG 100, as is known in the art. Upon receipt of such ac
signal within the IPG 100, it is rectified by rectifier circuitry
682 and converted back to a dc signal which is used to
18
replenish the power source 180 of the implant through a
charge controller IC 684. A battery protection IC 686
controls a FET switch 688 to make sure the battery 180 is
charged at the proper rate, and is not overcharged. A fuse 689
also protects the battery 180 from being charged with too
much current. The fuse 689 also protects from an excessive
discharge in the event of an external short circuit.
Thus, from FIG. 7A, it is seen that the battery charging
System consists of external charger circuitry 208, used on an
as-needed basis, and implantable circuitry contained within
the IPG 100. In the charger 208, the rechargeable Lithium
ion battery 277 (recharged through the base station 210), or
equivalent, provides a Voltage Source for the power amplifier
275 to drive the primary coil 279 at a resonant frequency.
15 The secondary coil 680, in the IPG 100, is tuned to the same
resonant frequency, and the induced AC voltage is converted
to a DC voltage by rectifier circuit 682. In a preferred
embodiment, the rectifier circuit 682 comprises a bridge
rectifier circuit. The charge controller IC 684 coverts the
induced power into the proper charge current and Voltage for
the battery. The battery protection IC 686, with its FET
Switch 688, is in series with the charge controller 684, and
keeps the battery within Safe operating limits. Should an
Overvoltage, undervoltage, or short-circuit condition be
25 detected, the battery 180 is disconnected from the fault. The
fuse 689 in series with the battery 180 provides additional
overcurrent protection. Charge completion detection is
achieved by a back-telemetry transmitter 690, which trans
mitter modulates the Secondary load by changing the full
wave rectifier into a half-wave rectifier/voltage clamp. This
modulation is, in turn, Sensed in the charger 208 as a change
in the coil voltage due to the change in the reflected
impedance. When detected, an audible alarm is generated
through a back telemetry receiver 692 and speaker 693.
35 Reflected impedance due to Secondary loading is also used
to indicate charger/IPG alignment, as explained in more
detail below in conjunction with the description of FIG. 9.
In a preferred embodiment, and still with reference to
FIG. 7A, the charge coil 680 comprises a 36 turn, single
40 layer, 30 AWG copper air-core coil, and has a typical
inductance of 45 uH and a DC resistance of about 1.15
ohms. The coil 680 is tuned for resonance at 80 KHZ with
a parallel capacitor. The rectifier 682 comprises a full-wave
(bridge) rectifier consisting of four Schottky diodes. The
45 charge controller IC 684 comprises an off-the-shelf, linear
regulation battery charger IC available from Linear Tech
nology as part number LTC1731-4.1. Such charger is con
figured to regulate the battery voltage to 4.1VDC. When the
induced DC voltage is greater than 4.1 VDC (plus a 54 mV
50 dropout voltage), the charge controller 684 outputs a fixed
constant current of up to 80 mA, followed by a constant
voltage of 4.1+0.05 V. If insufficient power is received for
charging at the maximum rate of 80 mA, the charge con
troller 684 reduces the charge current So that charging can
55 continue. Should the battery voltage fall below 2.5 V, the
battery is trickled charged at 10 mA. The charge controller
684 is capable of recharging a battery that has been com
pletely discharged to Zero Volts. When the charge current
drops to 10% of the full-scale charge current, or 8 mA,
60 during the constant Voltage phase, an output flag is set to
Signal that charging has completed. This flag is used to gate
the oscillator output for modulating the rectifier configura
tion (full-wave to half-wave), which change in rectifier
configuration is Sensed by the external charging circuit to
65 indicate charge completion.
The battery protection IC 686, in the preferred
embodiment, comprises an off-the-shelf IC available from
 US 6,553,263 B1
19
Motorola as part number MC33349N-3R1. This IC monitors
the voltage and current of the implant battery 180 to ensure
Safe operation. Should the battery Voltage rise above a safe
maximum voltage, then the battery protection IC 686 opens
the charge-enabling FET switches 688 to prevent further
charging. Should the battery Voltage drop below a safe
minimum voltage, or should the charging current exceed a
Safe maximum charging current, the battery protection IC
686 prevents further discharge of the battery by turning off
the charge-enabling FET switches 688. In addition, as an
additional safeguard, the fuse 689 disconnects the battery
180 if the battery charging current exceeds 500 mA for at
least one Second.
In a preferred embodiment, the charge-enabling FET
Switches 688 comprise a FET and a Discharge FET con
nected in Series similar to the FETS 701 and 701 shown in
FIG. 9. In the event of a sensed malfunction, the protection
IC 686 switches off the battery 180 by turning off one of the
two FET switches 688. If the battery voltage is greater than
a predetermined value, the Charge FET is turned off to block
further charging. Conversely, if the battery voltage is leSS
than a predetermined value, the Discharge FET turns off to
block further discharging. If the battery voltage is Zero, both
the Charge FET and the Discharge FET turn off since the
Battery Protection circuit is powered directly from the
battery. Only when a charge Voltage greater than VGS, or the
gate-Source threshold Voltage, of the Charge FET is applied
(which is approximately 1.5 volts) will charging resume at
a rate lower than normal charging, i.e., 10% fo the normal
rate, until the Voltage has reached a predetermined level.
Turning next to FIG. 7B, a summary of the preferred
misalignment detection circuitry and charge completion
detection circuitry used by the invention is illustrated. AS
seen in FIG. 7B, an external power source 277, e.g., a
rechargeable or replaceable battery, drives a class E oscil
lator 275, which applies an ac Signal, e.g., a signal of about
80 KHZ, to the primary coil 279, which coil is also labeled
L1 in FIG. 7B. The voltage V at the coil L1 is monitored
by a first voltage detection circuit 695 and by a second
voltage detection circuit 697. Both of the voltage detection
circuits 695 and 697 are connected to a speaker 693, or
equivalent audible-tone generator.
The coil L1 couples energy 290 through the skin 278 of
the user to an implanted coil L2 (also referred to as coil 680)
that is part of the implanted device. The coil L2 inductively
(electromagnetically) receives the ac Signal 290. That is, the
ac signal 290 is induced in the coil L2 as a result of the
alternating magnetic field that is created when the Signal is
applied to the external coil L1. The alternating Signal
received at coil L2 is rectified by the Switch regulator 682,
thereby creating a dc voltage that is applied to charging and
protection circuitry 685 for delivery to the implanted
rechargeable battery 180. The battery 180, in turn, provides
operating power for the electronic circuitry 687 included
within the implant device So that Such device may carry out
its intended function, e.g., provide Stimulation pulses
through implanted electrodes to desired nerves or body
tissue. The circuitry 685 controls how much charging cur
rent is applied to the battery 180 and monitors the battery
Voltage. The Switch regulator 682 operates as either a
full-wave rectifier circuit or a half-wave rectifier circuit as
controlled by a control signal SW1 generated by the charg
ing and protection circuitry 685.
In normal operation, that is, when the battery 180 has been
depleted and is receiving a charge, the Switch rectifier 682
operates as a full-wave rectifier circuit. During this time,
assuming that the coils L1 and L2 are properly aligned, the
20
voltage V. sensed by voltage detector 695 is at a minimum
level because a maximum energy transfer is taking place.
Should the coils L1 and L2 become misaligned, then less
than a maximum energy transfer occurs, and the voltage V
monitored by detection circuit 695 significantly increases. If
the voltage V is greater than a prescribed threshold level,
then voltage detection circuit 695 causes the speaker 693 to
emit a fist audible Sound, which first audible Sound indicates
a misaligned condition. AS Soon as the coils L1 and L2 are
placed in proper alignment, an optimum energy transfer
condition is established, causing the Voltage V to decrease
below the threshold, thereby causing the detection circuit
695 to cease emitting the first audible sound. In this manner,
then, it is seen that the detection circuit 695 operates as a
15 misalignment detector, providing audible feedback as to
when a misaligned condition between the coils L1 and L2 is
present. Visual feedback could also be provided, if desired.
AS the battery 180 continues to be charged, the charging
and protection circuitry continue to monitor the charge
current and battery Voltage. When the charge current and
battery Voltage reach prescribed levels, which prescribed
levels are indicative of a fully charged battery, the Signal
SW1 is generated by the charging and protection circuitry
685. The signal SW1, in turn, causes the Switch rectifier
25 circuit 682 to Switch to half-wave rectifier operation. When
this change occurs, the Voltage V Sensed by Voltage detec
tor 697 Suddenly changes from a minimal peak-to-peak
amplitude to a larger peak-to-peak amplitude, as shown in
FIG. 7B. The detector 697 is adapted to sense this sudden
transient or pulsed change in amplitude, and in response
thereto causes a 2nd audible Sound, e.g., a beeping Sound, to
be generated through the speaker 693. This second audible
Sound thus signals the user that the battery is fully charged.
Visual feedback could be used in lieu of, or in addition to,
35 the 2nd audible Sound, if desired.
It is noted that the operation of the misalignment and
full-charge detection circuits, illustrated in FIG. 7B, operate
without the use of conventional rf backtelemetry Signals
being Sent from the implanted device to an external device.
40 In practice, Such conventional backtelemetry rf Signals may
be used to signal the hand held programmer (HHP), when
placed in telecommunicative contact with the implanted
device, in order to provide a status report regarding the State
of the charge of the battery 180 or other conditions within
45 the implant device. However, it should be noted that the
Switch rectifier 682 may be modulated, by Switching back
and forth between full-wave and half-wave conditions, in
order to create data words in the modulation pattern of the
voltage V that may be sensed and decoded at the external
50 device, thereby providing a means for backtelemetry com
munication without using conventional rf Signal generation,
modulation, and transmission.
Next, with reference to FIG. 8, a state diagram that shows
the various charging States that may occur in a preferred
55 embodiment of the invention relative to the implant battery
180 is shown. As seen in FIG. 8, and assuming a preferred
lithium-ion or lithium-ion polymer battery is used, a normal
state 710 reflects that the battery voltage and charging
current are within appropriate limits. An over Voltage State
60 712 exists when the battery voltage is greater than about
4.25 V and continues to exist until the battery voltage is less
than about 4.05 V. An undervoltage state 714 exists when the
battery Voltage is less than 2.5 volts. The underVoltage State
714 continues to exist until the battery Voltage is greater than
65 2.5 volts while charging at a prescribed trickle charge
current, e.g., 10 mA. An overcurrent (charging) State 716
exists whenever the charging current exceeds 80 mA. If,
 US 6,553,263 B1
21
while in the overcurrent (charging) state 716, the battery
Voltage is greater than 4.25 Volts, then the Over Voltage State
712 is entered. If, while in the overcurrent (charging) State
716, the charging current exceeds 500 mA for more than one
minute, the fuse 689 opens, and a cell disconnect state 720
is permanently entered. An overcurrent (discharging) State
718 is entered whenever the battery charging current is
greater than 100 mA, and continues until the battery charg
ing current is less than 100 mA. If, while in the overcurrent
(discharging) state 718, the battery voltage drops below 2.5
volts, then the under voltage state 714 is entered. Also,
should the battery current exceed 500 mA for more than one
minute while in the overcurrent (discharging) state 718, the
fuse 689 opens, and the cell disconnect state 720 is perma
nently entered.
Thus, it is seen that through operation of the States shown
in FIG. 8, the rechargeable battery 180 is fully protected
from all conditions-over Voltage, under Voltage,
overcharge, and undercharge-that may exist and which
could potentially damage the battery or shorten its operating
life.
Turning next to FIG. 9, a block diagram of the preferred
circuitry within the external charging station 208 is shown.
The charging Station comprises a portable, non-invasive
transcutaneous energy transmission System designed to fully
charge the implant battery in under three hours (80% charge
in two hours). Energy for charging the IPG battery 180
initially comes from the main Supply line 211, and is
converted to 5 VDC by an AC-DC transformer 694, which
5 VDC proves the proper Supply Voltage for the charger base
station 210. When the charger 208 is placed on the charger
base station 210, the Lithium-ion battery 277 in the charger
is fully charged in approximately four hours. Once the
battery 277 is fully charged, it has enough energy to fully
recharge the implant battery 180 (FIG. 7A or FIG.7B). If the
charger 208 is not used and left on the charger base Station
210, the battery 277 will self-discharge at a rate of about
10% per month.
Still with reference to FIG. 9, once the voltage of the
battery 277 falls below a first prescribed limit, e.g., 4.1
VDC, during a Standby mode, charging of the battery is
automatically reinitiated. In addition, should the external
charger battery 277 be discharged below a second prescribed
limit, e.g., 2.5 VDC, the battery 277 is trickled charged until
the Voltage is above the Second prescribed limit, at which
point normal charging resumes.
A battery protection circuit 698 monitors if an over
Voltage, under Voltage, or overcurrent condition occurs, and
disconnects the battery, e.g., through opening at least one of
the FET switches 701 and/or 702, or from the fault until
normal operating conditions exist. Another Switch 699, e.g.,
a thermal fuse, will disconnect the battery should the charg
ing or discharging current exceed a prescribed maximum
current for more than a prescribed time, e.g., 1.5 A for more
than 10 seconds.
The battery 277 provides a power source for the RF
amplifier 275. The RF amplifier, in a preferred embodiment,
comprises a class E amplifier configured to drive a large
alternating current through the coil 279.
Still with reference to FIG. 9, an alignment detection
circuit 695 detects the presence of the IPG 100 through
changes in the reflected impedance on the coil 279, as
described above in connection with FIG. 7B. Reflected
impedance is a minium when proper alignment has been
obtained. This means that the Steady-state Voltage V1 Sensed
at the coil 279 is also at a minimum because maximum
22
coupling occurs. When maximum coupling is detected, e.g.,
when V1 is at a minimum, an audible or visual alarm may
Sound. In a preferred embodiment, a first audible tone is
generated whenever alignment is not achieved. Thus, as a
charging operation begins, the first audible tone Sounds, and
the user seeks to position the charger 208 (or at least to
position the coil 279) at a location that causes the first
audible tone to cease. Similarly, a charge complete detection
circuit 697 alerts the user through generation of a second
audible tone (preferably an ON-OFF beeping sound) when
the IPG battery 180 is fully charged. A fully charged
condition is also Sensed by monitoring the reflected imped
ance through the coil 279. As indicated above, a fully
charged condition is signaled from the IPG by Switching the
15 rectifier circuit 682 within the IPG from a full-wave rectifier
circuit to a half-wave rectifier circuit. When Such rectifier
Switching occurs, the Voltage V1 Suddenly increases (e.g., a
transient or pulsed component appears in the Voltage V1)
because the amount of reflected energy Suddenly increases.
This sudden increase in V1 is detected by the charge
complete detection circuit 697, and once detected causes the
Second audible tone, or tone Sequence, to be broadcast via
the speaker 693 in order to signal the user that the implant
battery 180 is fully charged.
25 Thus, it is seen that invention provides an implant device
having a rechargeable internal battery as well as the control
System used to monitor the battery's State of charge and
circuitry to control the charging process. The System moni
tors the amount of energy used by the implant System and
hence the state of charge of the battery. Through bidirec
tional telemetry (forward and back telemetry) with the hand
held programmer 202 and/or the clinician programmer 204,
the System is able to inform the patient or clinician of the
Status of the System, including the State of charge, and
35 further make requests to initiate an external charge process
when needed. The acceptance of energy from the external
charger is entirely under the control of the implanted System.
Advantageously, both physical and Software control exist to
ensure reliable and Safe use of the recharging System.
40 AS indicated previously, conventional lithium-ion batter
ies are not Susceptible to being discharged to Zero Volts
without Suffering irreversible damage. In contrast, the
present invention uses a lithium-ion or lithium-ion polymer
battery that has been modified to allow a Zero volt discharge
45 condition to occur without causing irreversible damage to
the battery. Such modified lithium-ion battery has a cell
structure as-depicted in FIG. 10A. As seen in FIG. 10A, the
battery cell includes an anode 736 and a cathode 732. The
anode is made from graphite that is placed on a titanium
50 substrate 740. The cathode is preferably made from LiNi
CoO (lithium-nickel-cobalt oxide) that coats an aluminum
(Al) substrate 730. An electrolyte and separator 734 separate
the cathode from the anode.
The battery cell structure shown in FIG. 10A differs
55 Significantly from conventional Lithium-ion batteries. First,
Such a modified lithium-ion battery utilizes an anode
(current-collector) electrode having a Substrate that is made
from titanium instead of copper. This allows the cell to drop
to Zero Volts without causing irreversible damage. Second,
60 the cathode electrode of the battery is made from LiNiCoO
instead of LiCoO2. Third, the separator used inside the
battery is made from a ceramic instead of PE. Fourth, for a
lithium-ion polymer battery, the electrolyte within the bat
tery is preferably realized using a Solid polymer conductor
65 instead of LiPF6/EC+DEC, which is the electrolyte typically
used in a lithium-ion battery. Additionally, the battery case
may be coated with ferrite to further minimize eddy current
 US 6,553,263 B1
23
heating. A “Zero-volt technology' battery made in accor
dance with the present invention will always include at least
the first modification mentioned above, i.e., an anode elec
trode having a Substrate made from titanium (or a Suitable
titanium alloy), as opposed to copper, because this is the
change needed to allow the battery cell Voltage to drop to
Zero volts without causing irreversible damage to the battery
cell.
When a modified lithium-ion battery as shown in FIG.
10A is discharged, it may discharge to Zero Volts without
damage. When Such a discharged-to-Zero-volts battery is
recharged, the Voltage versus current relationship during the
charging operation, assuming the charging circuit shown in
FIG. 7A is employed, is substantially as shown in FIG. 10B.
Of course, if the battery 180 has been discharged to zero
Volts, then no circuitry within the implant device may
operate because there is no operating power. However, as
Soon as an external charger 208 begins coupling energy into
the implant device, this energy is rectified and provides a dc
operating Voltage that allows the charge control IC 684 and
battery protection IC 686 to begin to function, directing the
appropriate charge current to the discharged battery 180. AS
seen in FIG. 10B, in a very short time, e.g., within about 10
seconds or so, the battery voltage will rise to about 0.3 V.
From that initial Starting point, the battery Voltage gradually
increases, almost in a linear manner, until it reaches about
1.5 volts after about being charged for about 2 minutes and
35 seconds. Thereafter, the battery continues to charge (not
shown in FIG. 10B), until the battery voltage reaches a full
charge of about 4.1 volts after about 2 hours or So.
Thus, as described above, it is seen that through use of a
rechargeable internal battery 180 within the IPG 100, the
SCS system and its control system are able to monitor the
State of charge and control the charging process of the
rechargeable battery 180. Through bi-directional telemetry
(forward and back telemetry) with the hand held program
mer 202 and/or the clinician programmer 204, the SCS
System is able to inform the patient or clinician of the Status
of the System, including the State of charge, and further make
requests to initiate an external charge process when needed.
The acceptance of energy from the external charger is
entirely under the control of the SCS implanted system.
Advantageously, Several layers of physical and Software
control exist to ensure reliable and Safe use of the recharging
System.
Also, as described above, it is seen that the invention
provides a rechargeable System for use with a medical
implant device or System that is characterized by the use or
inclusion of: (1) lithium-ion or lithium-ion polymer batter
ies; (2) lithium-ion Zero volt battery technology; (3) mis
alignment indication at the external location, responsive to
changes in reflected impedance from the implant location;
(4) a rechargeable recharger; (5) adhesive and/or Velcro(E/
adhesive charger attachment means; (6) over and under
charge protection circuitry, including automatic shut-off
circuitry; (7) back telemetry of implant battery charge level
to external hand-held or clinician's programmer; (8) an end
of charging modulating indicator within the implant device;
(9) a battery status indicator on the external charger device;
and (10) Single or dual rate charging circuitry, i.e., fast
charging at the Safer lower battery Voltages, and slower
charging when the battery is nearer to full charge higher
battery voltages,
While the invention herein disclosed has been described
by means of Specific embodiments and applications thereof,
numerous modifications and variations could be made
thereto by those skilled in the art without departing from the
Scope of the invention Set forth in the claims.
24
What is claimed is:
1. An implantable medical System comprising:
an implantable medical device housed in an hermetically
Sealed case,
electronic circuitry housed in Said Sealed case that per
forms a desired circuit function;
a first rechargeable battery housed within Said Sealed case
that provides operating power for Said electronic
circuitry, wherein Said first rechargeable battery com
prises a lithium-ion battery configured to permit a
discharge to Zero volts without damage to the battery;
battery charging circuitry housed within Said Sealed case
that includes a coil, a rectifier circuit coupled to the
coil, and a charge controller circuit coupled to the
15 rectifier circuit, wherein Said battery charging circuitry
is adapted to inductively receive power from an exter
nal Source through said coil, rectify Said received
power with Said rectifier circuit, and direct Said rectified
received power as controlled by Said charge controller
circuit to the first rechargeable battery for the purpose
of recharging Said battery;
battery protection circuitry housed within Said Sealed case
that monitors and controls the manner in which the
battery charging circuitry recharges Said first recharge
25 able battery; and
an external charger, including a power Source and a
transmission circuit for transmitting power from the
power Source to the battery charging circuitry housed
within the Sealed case of the implantable medical
device.
2. The implantable medical system of claim 1 wherein
Said battery charging circuitry includes means for generating
a charging current, and wherein Said battery protection
circuitry includes means for monitoring the Voltage acroSS
35 the rechargeable battery and means for controlling how
much charging current is applied to Said first rechargeable
battery based on how much Voltage is present acroSS Said
rechargeable battery.
3. The implantable medical system of claim 2 wherein
40 Said battery protection circuitry allows a first charge current
to be applied to Said first rechargeable battery when the
battery voltage is between Zero volts and a first voltage V1,
allows a Second charge current to be applied to Said
rechargeable battery when the battery Voltage is between the
45 first voltage V1 and a second voltage V2, and allows a third
charge current to be applied to Said rechargeable battery
when the battery voltage is between the second voltage V2
and a full charged Voltage V3, wherein the first charge
current is a trickle charge current that is much less than the
50 Second charge current, and wherein the third charge current
is less than the Second charge current.
4. The implantable medical system of claim 3 wherein the
first rechargeable battery is configured to discharge to Zero
Volts without Suffering irreversible damage and to operate
55 without damage over a range of battery voltages ranging
from the first voltage V1 to the fully charged battery voltage
V3, which voltage V3 is about 4.1 V, wherein the first
voltage V1 is about 2.5V, and the second voltage V2 is about
4.0 V, and wherein the first charge current comprises a
60 current of about C/25 or less, where C is the battery capacity,
and wherein the Second charge current comprises a current
of about C/2, and wherein the third charge current comprises
a current of about C/10 or less.
5. The implantable medical system of claim 4 wherein the
65 battery protection circuitry further charges the battery with
a trickle charge current of about C/50 or less when the
battery voltage is less than about 1.0 V.
 US 6,553,263 B1
25
6. The implantable medical system of claim 2 wherein
Said battery protection circuitry further protects Said first
rechargeable battery from Overvoltage conditions.
7. The implantable medical system of claim 1 wherein
Said battery protection circuitry modulates the rectifier cir
cuit whenever the battery Voltage and the battery charging
current are at prescribed levels, indicating a fully-charged
battery condition; and wherein Said external charger detects
a change in reflected impedance when the rectifier circuit of
the implanted medical device is modulated, and in response
thereto generates a signal indicating that the first recharge
able battery is fully charged.
8. The implantable medical system of claim 1 further
including an external hand held programmer adapted to be
placed in telecommunicative contact with Said implantable
medical device for the purpose of Sending programming and
control Signals to the implantable medical device, and
wherein Said implantable medical device further includes a
back telemetry transmitter circuit that transmits Selected
data, including battery Status data, through the coil of the
battery charging circuitry to the hand held programmer, and
wherein the hand held programmer includes means for
receiving and displaying the battery Status data from the
implantable medical device whenever the hand held pro
grammer is placed in telecommunicative contact with the
implantable medical device.
9. The implantable medical system of claim 1 wherein
Said external charger includes a mis-alignment detection
circuit adapted to detect when the external charger is mis
aligned with the coil of the battery charging circuitry So as
to prevent optimum power transfer from the external charger
to the implantable medical device.
10. The implantable medical System of claim 9 wherein
the external charger further includes an audible alarm that
emits a specified tone when a misaligned condition exists
between the external charger and the implantable medical
device, and wherein the Specified tone ceases to be emitted
when an aligned condition exists between the external
charger and the implantable medical device.
11. The implantable medical system of claim 10 further
including means for Securing the external charger in an
aligned location relative to the implantable medical device
while the rechargeable battery of the implantable medical
device is being recharged.
12. The implantable medical system of claim 11 wherein
the Securing means comprises a disposable adhesive pouch
adapted to be affixed to a skin Surface of a perSon using the
implantable medical device.
13. The implantable medical system of claim 11 wherein
the Securing means comprises a patch adapted to be remov
ably affixed to a skin Surface of a perSon using the implant
able medical device, the patch having Securing means
thereon for holding the external charger thereto.
14. The implantable medical system of claim 1 wherein
the external charger comprises a base Station and a mobile
charger unit, the base Station including means for holding
the mobile charger unit in electrical contact there with when
ever the mobile charger unit is detachably engaged there
with, and wherein the mobile charger unit has a Second
rechargeable battery housed within it, wherein the Second
rechargeable battery within the mobile charger unit com
prises the power Source through which power is inductively
coupled into the implantable medical device when recharg
ing the rechargeable battery housed within the Sealed cased
of the implantable medical device.
15. The implantable medical system of claim 14 wherein
the base Station includes a primary power Source, and
26
wherein the mobile charger unit includes battery charging
and protection circuitry that directs power from the prima
rily power Source of the base Station to the Second recharge
able battery for the purpose of recharging the Second
rechargeable battery when the mobile charger unit is detach
ably engaged with the base Station.
16. The implantable medical system of claim 15 wherein
the Second rechargeable battery comprises a Lithium-ion
battery.
17. An implantable medical System comprising:
an implantable medical device housed in an hermetically
Sealed case,
electronic circuitry housed in Said Sealed case that per
15 forms a desired circuit function;
a rechargeable battery housed within Said Sealed case that
provides operating power for Said electronic circuitry,
wherein Said rechargeable battery comprises a Lithium
ion battery configured to permit a discharge to Zero
Volts without damage to the battery; and
battery charging and protection circuitry housed within
Said Sealed case that includes
means for inductively receiving power from an external
25 SOurce,
means for monitoring the Voltage acroSS Said recharge
able battery, and
means for recharging Said rechargeable battery with the
power received from the external Source at a rate
controlled by the monitored Voltage across the
rechargeable battery;
an external charger having a power Source and a trans
mission circuit for transmitting power from the power
Source to the battery charging and protection circuitry
35
housed within the Sealed case of the implantable medi
cal device.
18. The implantable medical system of claim 17 wherein
the recharging means comprises means for recharging the
40 rechargeable battery at a first recharging rate when the
battery voltage is between Zero volts and a first voltage V1,
at a Second recharging rate when the battery Voltage is
between the first voltage V1 and a second voltage V2, and
a third recharging rate when the battery Voltage is between
45 the second voltage V2 and a full charged voltage V3,
wherein the first recharging rate comprises a trickle charge
rate that is much less than the Second recharging rate, and
wherein the third recharging rate is less than the Second
recharging rate and greater than the first recharging rate.
50 19. The implantable medical system of claim 17 wherein
the recharging means comprises means for recharging the
rechargeable battery with a first charging current when the
battery voltage is between Zero volts and a first voltage V1,
a Second charging current when the battery Voltage is
55 between the first voltage V1 and a second voltage V2, and
a third charging current when the battery Voltage is between
the second voltage V2 and a full charged voltage V3,
wherein the first charging current comprises a trickle charge
current that is much less than the Second charging current,
60 and wherein the third charging current is less than the Second
charging current and greater than the first charging current.
20. The implantable medical system of claim 17 wherein
the first voltage V1 is about 2.5 V, the second voltage V2 is
about 4.0 V, and the third voltage V3 is about 4.1 V, and
65 wherein the first charging current comprises a current of
about C/25 or less, where C is the battery capacity, and
wherein the Second charging current comprises a current of
 US 6,553,263 B1
27
about C/2, and wherein the third charging current comprises
a current of about C/10 or less.
21. An implantable medical System comprising:
an implantable medical device housed in an hermetically
Sealed case,
electronic circuitry housed in Said Sealed case that per
forms a desired circuit function;
a Lithium-ion rechargeable battery housed within Said
Sealed case that provides operating power for Said
electronic circuitry, wherein Said Lithium-ion recharge
able battery comprises a Zero-volt technology Lithium
ion battery that includes an anode electrode Substrate
made from titanium or a titanium alloy, wherein the
Zero-volt technology Lithium-ion battery is configured
to permit a discharge to Zero Volts without damage to
the battery;
28
battery charging and protection circuitry housed within
Said Sealed case that includes means for receiving
power from an external Source, means for monitoring
the Voltage acroSS the Zero-volt technology Lithium-ion
battery, and means for recharging the Zero-volt tech
nology Lithium-ion battery with the power received
from the external Source at a recharging rate controlled
by the monitored Voltage across the Zero-volt technol
1O
ogy Lithium-ion battery; and
an external charger having a power Source and a trans
mission circuit, wherein power from the power Source
is transmitted to the battery charging and protection
circuitry housed within the implantable medical device
15 through the transmission circuit.
k k k k k