U.S. patent application number 11/322788 was filed with the patent office on 2007-03-01 for optimal electrode contact polarity configurations for implantable stimulation systems.
Invention is credited to Rafael Carbunaru, Kristen N. Jaax, James C. Makous, Todd K. Whitehurst.
Application Number | 20070049988 11/322788 |
Document ID | / |
Family ID | 38049329 |
Filed Date | 2007-03-01 |
United States Patent
Application |
20070049988 |
Kind Code |
A1 |
Carbunaru; Rafael ; et
al. |
March 1, 2007 |
Optimal electrode contact polarity configurations for implantable
stimulation systems
Abstract
Systems for treating a patient with a medical condition include
a lead having an array of electrode contacts each being
programmable to have either a first polarity or a second polarity
and a programming device configured to test a multiplicity of
different electrode contact polarity configurations in which a
programmed polarity of one or more of the electrode contacts is
varied. Methods of using an implantable stimulator system include
implanting a lead having an array of programmable electrode
contacts disposed thereon in communication with a stimulation site,
testing a multiplicity of different electrode contact polarity
configurations in which a programmed polarity of one or more of the
electrode contacts is varied, selecting an optimal electrode
contact polarity configuration out of the multiplicity of different
electrode contact polarity configurations, and applying the
stimulation current via the optimal electrode contact polarity
configuration to the stimulation site in accordance with one or
more stimulation parameters.
Inventors: |
Carbunaru; Rafael; (Studio
City, CA) ; Jaax; Kristen N.; (Saugus, CA) ;
Whitehurst; Todd K.; (Santa Clarita, CA) ; Makous;
James C.; (Santa Clarita, CA) |
Correspondence
Address: |
STEVEN L. NICHOLS;RADER, FISHMAN & GRAVER PLLC
10653 S. RIVER FRONT PARKWAY
SUITE 150
SOUTH JORDAN
UT
84095
US
|
Family ID: |
38049329 |
Appl. No.: |
11/322788 |
Filed: |
December 30, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60661700 |
Mar 14, 2005 |
|
|
|
Current U.S.
Class: |
607/59 |
Current CPC
Class: |
A61N 1/0551 20130101;
A61N 1/37518 20170801; A61N 1/3605 20130101; A61N 1/3756 20130101;
A61N 1/37205 20130101 |
Class at
Publication: |
607/059 |
International
Class: |
A61N 1/00 20060101
A61N001/00 |
Claims
1. A system for treating a patient with a medical condition, said
system comprising: a lead having an array of electrode contacts
each being programmable to have either a first polarity or a second
polarity; and a programming device configured to test a
multiplicity of different electrode contact polarity configurations
in which a programmed polarity of one or more of said electrode
contacts is varied.
2. The system of claim 1, wherein said programming device is
further configured to select an optimal electrode contact polarity
configuration out of said multiplicity of different electrode
contact polarity configurations.
3. The system of claim 2, further comprising: a stimulator
configured to apply a stimulation current to a stimulation site in
accordance with one or more stimulation parameters using said
optimal electrode contact polarity configuration.
4. The system of claim 3, wherein said programming device is
further configured to: test a multiplicity of different sets of
said stimulation parameters; select an optimal set of said
stimulation parameters out of said multiplicity of different sets
of stimulation parameters; and signal to said stimulator to apply
said stimulation current according to said optimal set of
stimulation parameters; wherein each set of said stimulation
parameters comprises different values for at least one or more of a
frequency, pulse width, amplitude, burst pattern, duty cycle, ramp
on time, and ramp off time of said stimulation current.
5. The system of claim 3, wherein said programming device is
configured to select said optimal electrode contact polarity
configuration by: signaling said stimulator to apply a stimulus to
said stimulation site with each of said multiplicity of different
electrode contact polarity configurations; and selecting said
optimal electrode contact polarity configuration based on at least
one or more of an optimal response of said stimulation site to said
stimulus and a maximum amount of relief from said medical condition
from said stimulation current.
6. The system of claim 3, wherein said stimulation site comprises
at least one or more of an occipital nerve and a trigeminal
nerve.
7. The system of claim 3, wherein said stimulation current
comprises at least one or more of a monopolar stimulation current
and a multipolar stimulation current.
8. The system of claim 3, wherein said programming device is
included within said stimulator.
9. The system of claim 1, wherein said medical condition comprises
at least one or more of a headache, occipital neuralgia, facial
pain, and Bells palsy.
10. The system of claim 1, wherein said programming device
comprises at least one or more of a clinician programming system
and a hand held programmer.
11. A method of using an implantable stimulator system, said method
comprising: implanting a lead in communication with a stimulation
site, said lead having an array of electrode contacts disposed
thereon for applying a stimulation current to said stimulation
site, each electrode contact being programmable to have either a
first polarity or a second polarity; testing a multiplicity of
different electrode contact polarity configurations in which a
programmed polarity of one or more of said electrode contacts is
varied; selecting an optimal electrode contact polarity
configuration out of said multiplicity of different electrode
contact polarity configurations; and applying said stimulation
current via said optimal electrode contact polarity configuration
to said stimulation site in accordance with one or more stimulation
parameters.
12. The method of claim 11, further comprising: testing a
multiplicity of different sets of said stimulation parameters;
selecting an optimal set of said stimulation parameters out of said
multiplicity of different sets of stimulation parameters; and
applying said stimulus to said stimulation site according to said
optimal set of said stimulation parameters; wherein each of said
sets of said stimulation parameters comprises different values for
at least one or more of a frequency, pulse width, amplitude, burst
pattern, duty cycle, ramp on time, and ramp off time of said
stimulus.
13. The method of claim 11, wherein said selecting said optimal
electrode contact polarity configuration comprises: selecting said
optimal electrode contact polarity configuration based on at least
one or more of an optimal response to said stimulation current by
said stimulation site and a maximum amount of relief from a medical
condition resulting from said stimulation current.
14. The method of claim 11, further comprising using said
stimulator system to treat at least one or more of a headache,
occipital neuralgia, facial pain, and Bells palsy.
15. The method of claim 11, wherein said stimulation site comprises
at least one or more of an occipital nerve and a trigeminal
nerve.
16. The method of claim 11, wherein said first polarity comprises
an anodic polarity and said second polarity comprises a cathodic
polarity.
17. The method of claim 11, wherein said stimulation current
comprises at least one or more of a monopolar stimulation current
and a multipolar stimulation current.
18. The method of claim 11, further comprising automatically
performing said steps of testing of said multiplicity of different
electrode contact polarity configurations and selecting said
optimal electrode contact polarity configuration with a
processor.
19. A system for treating a patient with a medical condition, said
system comprising: a lead having an array of electrode contacts
disposed thereon for applying a stimulation current to a
stimulation site, each electrode contact being programmable to have
either a first polarity or a second polarity; means for testing a
multiplicity of different electrode contact polarity configurations
in which a programmed polarity of one or more of said electrode
contacts is varied; means for selecting an optimal electrode
contact polarity configuration out of said multiplicity of
different electrode contact polarity configurations; and means for
applying said stimulation current via said optimal electrode
contact polarity configuration to said stimulation site in
accordance with one or more stimulation parameters.
20. The system of claim 19, further comprising: means for testing a
multiplicity of different sets of said stimulation parameters;
means for selecting an optimal set of said stimulation parameters
out of said multiplicity of different sets of stimulation
parameters; and means for applying said stimulation current to said
stimulation site according to said optimal set of said stimulation
parameters; wherein each of said sets of said stimulation
parameters comprises different values for at least one or more of a
frequency, pulse width, amplitude, burst pattern, duty cycle, ramp
on time, and ramp off time of said stimulation current.
Description
RELATED APPLICATIONS
[0001] The present application claims the priority under 35 U.S.C.
.sctn. 119 (e) of previous U.S. Provisional Patent Application No.
60/661,700, filed Mar. 14, 2005 for "Headache Treatment." This
provisional application is hereby incorporated by reference in its
entirety.
BACKGROUND
[0002] A wide variety of medical conditions and disorders have been
successfully treated using an implantable stimulator. Implantable
stimulators typically stimulate internal tissue, such as a nerve,
by emitting an electrical stimulation current according to
programmed stimulation parameters.
[0003] One type of implantable stimulator is known as a
microstimulator. Microstimulators are typically formed with a
small, cylindrical housing containing electronic circuitry that
produces the desired electric stimulation current between spaced
electrodes. These stimulators are implanted proximate to the target
tissue so that the stimulation current produced by the electrodes
stimulates the target tissue to reduce symptoms or otherwise
provide therapy for a wide variety of conditions and disorders.
Exemplary microstimulators are described in U.S. Pat. Nos.
5,312,439; 5,193,539; 5,193,540; and 5,405,367; 6,185,452; and
6,214,032. All of these listed patents are incorporated by
reference in their respective entireties.
[0004] Another type of implantable stimulator is known as an
implantable pulse generator (IPG). A typical IPG includes a
multi-channel pulse generator housed in a rounded titanium case.
The IPG is generally coupled to a lead with a number of electrodes
disposed thereon. Stimulation current is generated by the IPG and
delivered to target tissue via the electrodes on the lead.
Exemplary IPGs are described in U.S. Pat. Nos. 6,381,496;
6,553,263; and 6,760,626. All of these listed patents are
incorporated by reference in their respective entireties.
[0005] As will be readily appreciated, a key part of patient
treatment using an implanted stimulator is the proper placement of
the stimulator such that the stimulation electrodes are proximate
to the stimulation site to be stimulated. If the stimulation
electrodes are optimally placed near the stimulation site,
stimulation can be affected over a wide range of parameters and
power consumption can be minimized. However, optimal placement of a
stimulator within a patient is often difficult to accomplish.
SUMMARY
[0006] Systems for treating a patient with a medical condition
include a lead having an array of electrode contacts each being
programmable to have either a first polarity or a second polarity
and a programming device configured to test a multiplicity of
different electrode contact polarity configurations in which a
programmed polarity of one or more of the electrode contacts is
varied.
[0007] Methods of using an implantable stimulator system include
implanting a lead having an array of programmable electrode
contacts disposed thereon in communication with a stimulation site,
testing a multiplicity of different electrode contact polarity
configurations in which a programmed polarity of one or more of the
electrode contacts is varied, selecting an optimal electrode
contact polarity configuration out of the multiplicity of different
electrode contact polarity configurations, and applying the
stimulation current via the optimal electrode contact polarity
configuration to the stimulation site in accordance with one or
more stimulation parameters.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The accompanying drawings illustrate various embodiments of
the present invention and are a part of the specification. The
illustrated embodiments are merely examples of the present
invention and do not limit the scope of the invention.
[0009] FIG. 1A depicts the upper cervical spine area of a patient
and shows a number of nerves originating in the upper cervical
spine area.
[0010] FIG. 1B shows various nerves in the back of the head and
neck.
[0011] FIG. 1C illustrates a view of the major nerves and arteries
in the human head as viewed from above looking down on the top or
superior part of the head.
[0012] FIGS. 1D and 1E depict the trigeminal nerve and its
branches.
[0013] FIG. 2 illustrates an exemplary stimulator that may be used
to apply a stimulus to a target nerve to treat a particular medical
condition according to principles described herein.
[0014] FIG. 3 illustrates an exemplary microstimulator that may be
used as the stimulator according to principles described
herein.
[0015] FIG. 4 depicts a number of stimulators configured to
communicate with each other and/or with one or more external
devices according to principles described herein.
[0016] FIGS. 5A-5H illustrate a number of exemplary electrode
contact arrangements that may be a part of a stimulating lead that
is used to apply a stimulation at one or more stimulation sites
within a patient according to principles described herein.
[0017] FIG. 6 is a graph illustrating the relative current
threshold values of monopolar, bipolar, and tripolar electrode
configurations as a function of distance from the stimulation site
according to principles described herein.
[0018] FIG. 7 is a flow chart illustrating an exemplary method of
current steering that may be used to determine the optimal
stimulation parameters for a patient according to principles
described herein.
[0019] FIGS. 8A-8C illustrate an exemplary method of current
steering according to principles described herein.
[0020] Throughout the drawings, identical reference numbers
designate similar, but not necessarily identical, elements.
DETAILED DESCRIPTION
[0021] Systems and methods for treating a patient with a medical
condition are described herein. A lead with an array of electrode
contacts is implanted in communication with a stimulation site. The
lead is coupled at a proximal end to an implantable stimulator that
is configured to generate a stimulus, such as an electrical
stimulation current. Each of the electrode contacts of the array
may be selectively programmed to function as an anode or cathode.
Thus, many different electrode contact polarity configurations can
be realized depending on which electrodes function as anodes and
which as cathodes. Current steering methods are then used to test a
multiplicity of different electrode contact polarity configurations
and select an optimal electrode contact polarity configuration for
applying the stimulus to a stimulation site within the patient.
[0022] In the following description, for purposes of explanation,
numerous specific details are set forth in order to provide a
thorough understanding of the present systems and methods. It will
be apparent, however, to one skilled in the art that the present
systems and methods may be practiced without these specific
details. Reference in the specification to "one embodiment" or "an
embodiment" means that a particular feature, structure, or
characteristic described in connection with the embodiment is
included in at least one embodiment. The appearance of the phrase
"in one embodiment" in various places in the specification are not
necessarily all referring to the same embodiment.
[0023] FIG. 1A depicts the upper cervical spine area (C1-C4) of a
patient. As shown in FIG. 1A, a number of nerves arise from the
upper cervical spine area (C1-C4). Examples of such nerves include,
but are not limited to, the greater occipital nerve(s)
[0024] (132), lesser occipital nerve(s) (134), greater auricular
nerve(s) (136), transverse cervical nerve(s) (138), supraclavicular
nerve(s) (139), and/or branches of any of these nerves.
[0025] FIG. 1B depicts the occipital nerves (130) in the back or
posterior portion of the head and upper neck area of a patient. As
shown in FIG. 1B, the occipital nerves (130) are divided into
greater (132) and lesser (134) occipital nerves. The occipital
nerves (130) lie subcutaneously in the posterior of the head and
upper neck and are therefore relatively easily accessed. Thus, as
will be described in more detail below, a stimulator and/or
electrode lead may be implanted in the posterior of the head or in
the upper neck area of a patient to provide a stimulus to the
occipital nerves (130).
[0026] FIG. 1C illustrates a view of the major nerves and arteries
in the human head as viewed from above looking down on the top or
superior part of the head. As shown in FIG. 1C, the greater
occipital nerves (132) extend to and across some of the top or
superior portion of the head. The lesser occipital nerves (134) may
also extend to or near the top or superior portion of the head.
Consequently, an implanted stimulator or an electrode lead may be
positioned along the posterior part of the head or on the superior
portion of the head and still provide a stimulus to the occipital
nerves (130).
[0027] FIGS. 1D and 1E depict the trigeminal nerve (100) and its
branches. The trigeminal nerve (100) and its branches are
responsible, in part, for the perception of head pain, including
headaches and facial pain. The trigeminal nerve (100) on each side
of the head arises from a trigeminal ganglion (102), which lies
within the skull in an area known as Meckel's cave (110). Access to
either trigeminal ganglion (102) may be achieved via the foramen
ovale (112) or the foramen rotundum (114).
[0028] Procedures that ablate the trigeminal ganglia (102) do not
disable the muscles of mastication, since the cell bodies of the
sensory portion of the nerve are within the trigeminal ganglia
(102), whereas the motor portion simply projects axons through the
ganglia (the motor neuron cell bodies are in the pons). This may
provide a mechanism for selective stimulation of the sensory cells
via appropriate placement of a stimulator for stimulation of one or
both trigeminal ganglia (102).
[0029] FIGS. 1D and 1E also show a number of braches of the
trigeminal nerve (100) including, but not limited to, the
ophthalmic nerve (120), the maxillary nerve (122), and the
mandibular nerve (124). The supraorbital nerve (not shown) is also
a branch of the trigeminal nerve (100). The ophthalmic nerve (120)
and the maxillary nerve (122) are entirely sensory, and
sufficiently separate to allow independent and selective
stimulation via appropriate placement of a stimulator.
[0030] The mandibular nerve (124) is both sensory and motor. The
mandibular nerve (124) innervates several facial muscles, including
the muscles of mastication and the tensor tympani, which
reflexively damps down the vibrations of the malleus by increasing
the tension in the tympanic membrane. However, just distal to the
foramen ovale (112), the mandibular nerve (124) splits into a
purely sensory branch that innervates the superior part of the
lower jaw. And, slightly more distally, another branch splits into
a purely sensory branch that innervates the inferior part of the
lower jaw. These branches may be sufficiently separate to allow
independent and selective stimulation via appropriate placement of
a stimulator.
[0031] It has been discovered that stimulating one or more of the
nerves in the head with an electrical stimulation current can
alleviate or eliminate headache pain. This is especially useful for
patients who do not respond to other forms of treatment or who do
not prefer any of the other forms of treatment. Consequently, a
stimulator may be implanted in a patient to deliver an electrical
stimulation current to one or more of the nerves in the head,
particularly the occipital nerves (130). This stimulation may be
effective to treat headache pain (including, but not limited to
chronic migraine headaches) and other types of pain or medical
conditions, such as occipital neuralgia, facial pain, Bells palsy,
etc. It will be recognized that the stimulator may additionally or
alternatively be implanted in any site within the body and
configured to treat any other medical condition such as, but not
limited to, incontinence, peripheral nerve damage, sexual
dysfunction, etc.
[0032] As used herein, and in the appended claims, the term
"stimulator" will be used broadly to refer any device that delivers
a stimulus, such as an electrical stimulation current, one or more
drugs or other chemical stimulation, thermal stimulation,
electromagnetic stimulation, mechanical stimulation, and/or any
other suitable stimulation at a stimulation site. Thus, the term
"stimulator" includes, but is not limited to, a stimulator,
microstimulator, implantable pulse generator (IPG), system control
unit (stimulator) or similar device.
[0033] The stimulation site referred to herein may include any
nerve, tissue, blood vessel, or other area within the patient. For
example, the stimulation site may include one or more of the
following nerves: any cranial nerve; the greater, lesser or third
occipital nerves; the trigeminal nerve; the infraorbital nerve; the
facial nerve; the maxillary nerve, the mandibular nerve and
divisions of those nerves such as the two branches of the
ophthalmic division of the trigeminal nerve, i.e., the
supratrochlear and supraorbital nerves; the zygomaticotemporal
nerve branching from the maxillary division of the trigeminal
nerve; the auriculotemporal nerve branching from the mandibular
division of the trigeminal nerve; the pudendal nerve; and the
cavernous nerve. The stimulation site may additionally or
alternatively include the cortex, spinal cord, or any other area of
the central nervous system. In some examples, the stimulation site
may include two or more stimulation sites, e.g., the occipital and
trigeminal nerves.
[0034] To facilitate an understanding of the methods of optimally
placing a stimulator within a patient to treat a medical condition,
a more detailed description of the stimulator and its operation
will now be given with reference to the figures. FIG. 2 illustrates
an exemplary stimulator (140) that may be implanted within a
patient (150) and used to apply a stimulus to a stimulation site,
e.g., an electrical stimulation of the stimulation site, an
infusion of one or more drugs at the stimulation site, or both. The
electrical stimulation function of the stimulator (140) will be
described first, followed by an explanation of the possible drug
delivery function of the stimulator (140). It will be understood,
however, that the stimulator (140) may be configured to provide
only electrical stimulation, only a drug stimulation, both types of
stimulation or any other type of stimulation as best suits a
particular patient.
[0035] The exemplary stimulator (140) shown in FIG. 2 is configured
to provide electrical stimulation at a stimulation site within a
patient and includes a lead (141) having a proximal end coupled to
the body of the stimulator (140). In some examples, as will be
described in more detail below, a distal end of the lead (141) may
be formed as a flat enlarged surface (162), referred to herein as a
paddle, and implanted such that it is in communication with a
stimulation site. As used herein and in the appended claims, the
term "in communication with" refers to the lead (141) or other
device being adjacent, in the general vicinity, in close proximity,
directly next to, or directly on the stimulation site such that a
desired stimulation can be effectively delivered.
[0036] A number of electrodes (142) may be disposed on the paddle
(162), as illustrated in FIG. 2. The electrodes (142) may be
arranged on the paddle (162) in a variety of different possible
configurations. As will be described in more detail below, the
electrodes (142) are configured to apply an electrical stimulation
current to the stimulation site as best suits a particular
application.
[0037] As illustrated in FIG. 2, the stimulator (140) includes a
number of components. It will be recognized that the stimulator
(140) may include additional and/or alternative components as best
serves a particular application. A power source (145) is configured
to output voltage used to supply the various components within the
stimulator (140) with power and/or to generate the power used for
electrical stimulation. The power source (145) may be a primary
battery, a rechargeable battery, super capacitor, a nuclear
battery, a mechanical resonator, an infrared collector (receiving,
e.g., infrared energy through the skin), a thermally-powered energy
source (where, e.g., memory-shaped alloys exposed to a minimal
temperature difference generate power), a flexural powered energy
source (where a flexible section subject to flexural forces is part
of the stimulator), a bioenergy power source (where a chemical
reaction provides an energy source), a fuel cell, a bioelectrical
cell (where two or more electrodes use tissue-generated potentials
and currents to capture energy and convert it to useable power), an
osmotic pressure pump (where mechanical energy is generated due to
fluid ingress), or the like. Alternatively, the stimulator (140)
may include one or more components configured to receive power from
another medical device that is implanted within the patient.
[0038] When the power source (145) is a battery, it may be a
lithium-ion battery or other suitable type of battery. When the
power source (145) is a rechargeable battery, it may be recharged
from an external system through a power link such as a radio
frequency (RF) power link. One type of rechargeable battery that
may be used is described in International Publication WO 01/82398
A1, published Nov. 1, 2001, and/or WO 03/005465 A1, published Jan.
16, 2003, both of which are incorporated herein by reference in
their respective entireties. Other battery construction techniques
that may be used to make a power source (145) include those shown,
e.g., in U.S. Pat. Nos. 6,280,873; 6,458,171, and U.S. Publications
2001/0046625 A1 and 2001/0053476 A1, all of which are incorporated
herein by reference in their respective entireties. Recharging can
be performed using an external charger.
[0039] The stimulator (140) may also include a coil (148)
configured to receive and/or emit a magnetic field (also referred
to as a radio frequency (RF) field) that is used to communicate
with, or receive power from, one or more external devices (151,
153, 155). Such communication and/or power transfer may include,
but is not limited to, transcutaneously receiving data from the
external device, transmitting data to the external device, and/or
receiving power used to recharge the power source (145).
[0040] For example, an external battery charging system (EBCS)
(151) may provide power used to recharge the power source (145) via
an RF link (152). External devices including, but not limited to, a
hand held programmer (HHP) (155), clinician programming system
(CPS) (157), and/or a manufacturing and diagnostic system (MDS)
[0041] (153) may be configured to activate, deactivate, program,
and test the stimulator (140) via one or more RF links (154, 156).
It will be recognized that the links, which are RF links (152, 154,
156) in the illustrated example, may be any type of link used to
transmit data or energy, such as an optical link, a thermal link,
or any other energy-coupling link. One or more of these external
devices (153, 155, 157) may also be used to control the infusion of
one or more drugs into the stimulation site.
[0042] Additionally, if multiple external devices are used in the
treatment of a patient, there may be some communication among those
external devices, as well as with the implanted stimulator (140).
Again, any type of link for transmitting data or energy may be used
among the various devices illustrated. For example, the CPS (157)
may communicate with the HHP (155) via an infrared (IR) link (158),
with the MDS (153) via an IR link (161), and/or directly with the
stimulator (140) via an RF link (160). As indicated, these
communication links (158, 161, 160) are not necessarily limited to
IR and RF links and may include any other type of communication
link. Likewise, the MDS (153) may communicate with the HHP (155)
via an IR link (159) or via any other suitable communication
link.
[0043] The HHP (155), MDS (153), CPS (157), and EBCS (151) are
merely illustrative of the many different external devices that may
be used in connection with the stimulator (140). Furthermore, it
will be recognized that the functions performed by any two or more
of the HHP (155), MDS (153), CPS (157), and EBCS (151) may be
performed by a single external device. One or more of the external
devices (153, 155, 157) may be embedded in a seat cushion, mattress
cover, pillow, garment, belt, strap, pouch, or the like so as to be
positioned near the implanted stimulator (140) when in use.
[0044] The stimulator (140) may also include electrical circuitry
(144) configured to produce electrical stimulation pulses that are
delivered to the stimulation site via the electrodes (142). In some
embodiments, as will be described in more detail below, the
stimulator (140) may be configured to produce monopolar
stimulation. The stimulator (140) may alternatively or additionally
be configured to produce multipolar stimulation including, but not
limited to, bipolar or tripolar stimulation.
[0045] The electrical circuitry (144) may include one or more
processors configured to decode stimulation parameters and generate
the stimulation pulses. In some embodiments, the stimulator (140)
has at least four channels and drives up to sixteen electrodes or
more. The electrical circuitry (144) may include additional
circuitry such as capacitors, integrated circuits, resistors,
coils, and the like configured to perform a variety of functions as
best serves a particular application.
[0046] The stimulator (140) may also include a programmable memory
unit (146) for storing one or more sets of data and/or stimulation
parameters. The stimulation parameters may include, but are not
limited to, electrical stimulation parameters, drug stimulation
parameters, and other types of stimulation parameters. The
programmable memory (146) allows a patient, clinician, or other
user of the stimulator (140) to adjust the stimulation parameters
such that the stimulation applied by the stimulator (140) is safe
and efficacious for treatment of a particular patient. The
different types of stimulation parameters (e.g., electrical
stimulation parameters and drug stimulation parameters) may be
controlled independently. However, in some instances, the different
types of stimulation parameters are coupled. For example,
electrical stimulation may be programmed to occur only during drug
stimulation or vice versa. Alternatively, the different types of
stimulation may be applied at different times or with only some
overlap. The programmable memory (146) may be any type of memory
unit such as, but not limited to, random access memory (RAM),
static RAM (SRAM), a hard drive, or the like.
[0047] The electrical stimulation parameters may control various
parameters of the stimulation current applied to a stimulation site
including, but not limited to, the frequency, pulse width,
amplitude, electrode configuration (i.e., anode-cathode
assignment), burst pattern (e.g., burst on time and burst off
time), duty cycle or burst repeat interval, ramp on time, and ramp
off time of the stimulation current that is applied to the
stimulation site. The drug stimulation parameters may control
various parameters including, but not limited to, the amount of
drugs infused at the stimulation site, the rate of drug infusion,
and the frequency of drug infusion. For example, the drug
stimulation parameters may cause the drug infusion rate to be
intermittent, constant, or bolus. Other stimulation parameters that
characterize other classes of stimuli are possible. For example,
when tissue is stimulated using electromagnetic radiation, the
stimulation parameters may characterize the intensity, wavelength,
and timing of the electromagnetic radiation stimuli. When tissue is
stimulated using mechanical stimuli, the stimulation parameters may
characterize the pressure, displacement, frequency, and timing of
the mechanical stimuli.
[0048] Specific stimulation parameters may have different effects
on different types of medical conditions. Thus, in some
embodiments, the stimulation parameters may be adjusted by the
patient, a clinician, or other user of the stimulator (140) as best
serves a particular medical condition. The stimulation parameters
may also be automatically adjusted by the stimulator (140), as will
be described below. For example, the amplitude of the stimulus
current applied to a stimulation site may be adjusted to have a
relatively low value so as to target relatively large diameter
fibers of the stimulation site. The stimulator (140) may also, or
alternatively, increase excitement of a stimulation site by
applying a stimulation current having a relatively low frequency
(e.g., less than 100 Hz) to the stimulation site. The stimulator
(140) may also decrease excitement of a stimulation site by
applying a relatively high frequency (e.g., greater than 100 Hz) to
the stimulation site. The stimulator (140) may also, or
alternatively, be programmed to apply the stimulation current to a
stimulation site intermittently or continuously.
[0049] Additionally, the exemplary stimulator (140) shown in FIG. 2
is configured to provide drug stimulation to a patient, for
example, a headache patient, by applying one or more drugs to a
stimulation site. For this purpose, a pump (147) may also be
included within the stimulator (140). The pump (147) is configured
to store and dispense one or more drugs, for example, through a
catheter (143). The catheter (143) is coupled at a proximal end to
the stimulator (140) and may have an infusion outlet (149) for
infusing dosages of the one or more drugs at the stimulation site.
In some embodiments, the stimulator (140) may include multiple
catheters (143) and/or pumps (147) for storing and infusing dosages
of the one or more drugs at the stimulation site.
[0050] The pump (147) or controlled drug release device described
herein may include any of a variety of different drug delivery
systems. Controlled drug release devices based upon a mechanical or
electromechanical infusion pump may be used. In other examples, the
controlled drug release device can include a diffusion-based
delivery system, e.g., erosion-based delivery systems (e.g.,
polymer-impregnated with drug placed within a drug-impermeable
reservoir in communication with the drug delivery conduit of a
catheter), electrodiffusion systems, and the like. Another example
is a convective drug delivery system, e.g., systems based upon
electroosmosis, vapor pressure pumps, electrolytic pumps,
effervescent pumps, piezoelectric pumps and osmotic pumps. Another
example is a micro-drug pump.
[0051] Exemplary pumps (147) or controlled drug release devices
suitable for use as described herein include, but are not
necessarily limited to, those disclosed in U.S. Pat. Nos.
3,760,984; 3,845,770; 3,916,899; 3,923,426; 3,987,790; 3,995,631;
3,916,899; 4,016,880; 4,036,228; 4,111,202; 4,111,203; 4,203,440;
4,203,442; 4,210,139; 4,327,725; 4,360,019; 4,487,603; 4,627,850;
4,692,147; 4,725,852; 4,865,845; 5,057,318; 5,059,423; 5,112,614;
5,137,727; 5,234,692; 5,234,693; 5,728,396; 6,368,315 and the like.
Additional exemplary drug pumps suitable for use as described
herein include, but are not necessarily limited to, those disclosed
in U.S. Pat. Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653;
5,097,122; 6,740,072; and 6,770,067. Exemplary micro-drug pumps
suitable for use as described herein include, but are not
necessarily limited to, those disclosed in U.S. Pat. Nos.
5,234,692; 5,234,693; 5,728,396; 6,368,315; 6,666,845; and
6,620,151. All of these listed patents are incorporated herein by
reference in their respective entireties.
[0052] The stimulator (140) of FIG. 2 is illustrative of many types
of stimulators that may be used to apply a stimulus to a
stimulation site to treat headaches and other medical conditions.
For example, the stimulator (140) may include an implantable pulse
generator (EPG) coupled to one or more leads having a number of
electrodes, a spinal cord stimulator (SCS), a cochlear implant, a
deep brain stimulator, a drug pump (mentioned previously), a
micro-drug pump (mentioned previously), or any other type of
implantable stimulator configured to deliver a stimulus at a
stimulation site within a patient. Exemplary IPGs suitable for use
as described herein include, but are not limited to, those
disclosed in U.S. Pat. Nos. 6,381,496; 6,553,263; and 6,760,626.
Exemplary spinal cord stimulators suitable for use as described
herein include, but are not limited to, those disclosed in U.S.
Pat. Nos. 5,501,703; 6,487,446; and 6,516,227. Exemplary cochlear
implants suitable for use as described herein include, but are not
limited to, those disclosed in U.S. Pat. Nos. 6,219,580; 6,272,382;
and 6,308,101. Exemplary deep brain stimulators suitable for use as
described herein include, but are not limited to, those disclosed
in U.S. Pat. Nos. 5,938,688; 6,016,449; and 6,539,263. All of these
listed patents are incorporated herein by reference in their
respective entireties.
[0053] Alternatively, the stimulator (140) may include an
implantable microstimulator, such as a BION.RTM. microstimulator
(Advanced Bionics.RTM. Corporation, Valencia, Calif.). Various
details associated with the manufacture, operation, and use of
implantable microstimulators are disclosed in U.S. Pat. Nos.
5,193,539; 5,193,540; 5,312,439; 6,185,452; 6,164,284; 6,208,894;
and 6,051,017. All of these listed patents are incorporated herein
by reference in their respective entireties.
[0054] FIG. 3 illustrates an exemplary microstimulator (200) that
may be used as the stimulator (140; FIG. 2) described herein. Other
configurations of the microstimulator (200) are possible, as shown
in the above-referenced patents and as described further below.
[0055] As shown in FIG. 3, the microstimulator (200) may include
the power source (145), the programmable memory (146), the
electrical circuitry (144), and the pump (147) described in
connection with FIG. 2. These components are housed within a
capsule (202). The capsule (202) may be a thin, elongated cylinder
or any other shape as best serves a particular application. The
shape of the capsule (202) may be determined by the structure of
the desired target nerve, the surrounding area, and the method of
implantation. In some embodiments, the volume of the capsule (202)
is substantially equal to or less than three cubic centimeters. In
some embodiments, the microstimulator (200) may include two or more
leadless electrodes (142) disposed on the outer surface of the
microstimulator (200).
[0056] The external surfaces of the microstimulator (200) may
advantageously be composed of biocompatible materials. For example,
the capsule (202) may be made of glass, ceramic, metal, or any
other material that provides a hermetic package that will exclude
water vapor but permit passage of electromagnetic fields used to
transmit data and/or power. The electrodes (142) may be made of a
noble or refractory metal or compound, such as platinum, iridium,
tantalum, titanium, titanium nitride, niobium or alloys of any of
these, in order to avoid corrosion or electrolysis which could
damage the surrounding tissues and the device.
[0057] The microstimulator (200) may also include one or more
infusion outlets (201). The infusion outlets (201) facilitate the
infusion of one or more drugs at a treatment site to treat a
particular medical condition. The infusion outlets (201) may
dispense one or more drugs directly to the treatment site.
Alternatively, catheters may be coupled to the infusion outlets
(201) to deliver the drug therapy to a treatment site some distance
from the body of the microstimulator (200). The stimulator (200) of
FIG. 3 also includes electrodes (142-1 and 142-2) at either end of
the capsule (202). One of the electrodes (142) may be designated as
a stimulating electrode to be placed close to the treatment site
and one of the electrodes (142) may be designated as an indifferent
electrode used to complete a stimulation circuit.
[0058] The microstimulator (200) may be implanted within a patient
with a surgical tool such as a hypodermic needle, bore needle, or
any other tool specially designed for the purpose. Alternatively,
the microstimulator (200) may be implanted using endoscopic or
laparoscopic techniques.
[0059] A stimulator may be configured to operate independently.
Alternatively, as shown in FIG. 4 and described in more detail
below, the stimulator (140) may be configured to operate in a
coordinated manner with one or more additional stimulators, other
implanted devices, or other devices external to the patient's body.
For instance, a first stimulator may control, or operate under the
control of, a second stimulator, other implanted device, or other
device external to the patient's body. The stimulator (140) may be
configured to communicate with other implanted stimulators, other
implanted devices, or other devices external to the patient's body
via an RF link, an untrasonic link, an optical link, or any other
type of communication link. For example, the stimulator (140) may
be configured to communicate with an external remote control unit
that is capable of sending commands and/or data to the stimulator
(140) and that is configured to receive commands and/or data from
the stimulator (140).
[0060] In order to determine the strength and/or duration of
electrical stimulation and/or amount and/or type(s) of stimulating
drug(s) required to most effectively treat a medical condition,
various indicators of the medical condition and/or a patient's
response to treatment may be sensed or measured. These indicators
include, but are not limited to, electrical activity of the brain
(e.g., EEG); neurotransmitter levels; hormone levels; metabolic
activity in the brain; blood flow rate in the head, neck or other
areas of the body; medication levels within the patient; patient
input, e.g. when prodromal symptoms are sensed the patient can push
a button on a remote control or other external unit; temperature of
tissue in the stimulation target region, including the occipital
nerve; physical activity level, e.g. based on accelerometer
recordings; brain hyperexcitability, e.g. increased response of
given tissue to the same input; indicators of collateral tissue
stimulation might be used to adjust stimulation parameters; and/or
detection of muscle tone in neck (mechanical strain, pressure
sensor, EMG). In some embodiments, the stimulator (140) may be
configured to change the stimulation parameters in a closed loop
manner in response to these measurements. The stimulator (140) may
be configured to perform the measurements. Alternatively, other
sensing devices may be configured to perform the measurements and
transmit the measured values to the stimulator (140). Exemplary
sensing devices include, but are not limited to, chemical sensors,
electrodes, optical sensors, mechanical (e.g., motion, pressure)
sensors, and temperature sensors.
[0061] Thus, one or more external devices may be provided to
interact with the stimulator (140), and may be used to accomplish
at least one or more of the following functions:
[0062] Function 1: If necessary, transmit electrical power to the
stimulator (140) in order to power the stimulator (140) and/or
recharge the power source (145).
[0063] Function 2: Transmit data to the stimulator (140) in order
to change the stimulation parameters used by the stimulator
(140).
[0064] Function 3: Receive data indicating the state of the
stimulator (140) (e.g., battery level, drug level, stimulation
parameters, etc.).
[0065] Additional functions may include adjusting the stimulation
parameters based on information sensed by the stimulator (140) or
by other sensing devices.
[0066] By way of example, an exemplary method of treating a patient
with a medical condition may be carried out according to the
following sequence of procedures. The steps listed below may be
modified, reordered, and/or added to as best serves a particular
application.
[0067] 1. A stimulator (140) is implanted so that its electrodes
(142) and/or infusion outlet (149) are coupled to or located near a
stimulation site (e.g., the occipital nerves or other nerves in the
patient's head). If the stimulator (140) is a microstimulator, such
as the microstimulator (200) described in FIG. 3, the
microstimulator itself may be coupled to the stimulation site.
[0068] 2. The stimulator (140) is programmed to apply at least one
stimulus to the stimulation site. The stimulus may include
electrical stimulation, drug stimulation, chemical stimulation,
thermal stimulation, electromagnetic stimulation, mechanical
stimulation, and/or any other suitable stimulation.
[0069] 3. When the patient desires to invoke stimulation, the
patient sends a command to the stimulator (140) (e.g., via a remote
control) such that the stimulator (140) delivers the prescribed
stimulation. The stimulator (140) may be alternatively or
additionally configured to automatically apply the stimulation in
response to sensed indicators of the medical condition.
[0070] 4. To cease stimulation, the patient may turn off the
stimulator (140) (e.g., via a remote control).
[0071] 5. Periodically, the power source (145) of the stimulator
(140) is recharged, if necessary, in accordance with Function 1
described above. As will be described below, this recharging
function can be made much more efficient using the principles
disclosed herein.
[0072] In other examples, the treatment administered by the
stimulator (140), i.e., drug therapy and/or electrical stimulation,
may be automatic and not controlled or invoked by the patient.
[0073] For the treatment of different patients, it may be desirable
to modify or adjust the algorithmic functions performed by the
implanted and/or external components, as well as the surgical
approaches. For example, in some situations, it may be desirable to
employ more than one stimulator (140), each of which could be
separately controlled by means of a digital address. Multiple
channels and/or multiple patterns of stimulation may thereby be
used to deal with the multiple medical conditions, such as, for
example, the combination of migraine with another form or forms of
headache or the combination of headache with facial or other
pain.
[0074] As shown in the example of FIG. 4, a first stimulator (140)
implanted beneath the skin of the patient (208) provides a stimulus
to a first location; a second stimulator (140') provides a stimulus
to a second location; and a third stimulator (140'') provides a
stimulus to a third location. As mentioned earlier, the implanted
devices may operate independently or may operate in a coordinated
manner with other implanted devices or other devices external to
the patient's body. That is, an external controller (250) may be
configured to control the operation of each of the implanted
devices (140, 140', and 140''). In some embodiments, an implanted
device, e.g. stimulator (140), may control, or operate under the
control of, another implanted device(s), e.g. stimulator (140')
and/or stimulator (140''). Control lines (262-267) have been drawn
in FIG. 4 to illustrate that the external controller (250) may
communicate or provide power to any of the implanted devices (140,
140', and 140'') and that each of the various implanted devices
(140, 140', and 140'') may communicate with and, in some instances,
control any of the other implanted devices.
[0075] As a further example of multiple stimulators (140) operating
in a coordinated manner, the first and second stimulators (140,
140') of FIG. 4 may be configured to sense various indicators of a
particular medical condition and transmit the measured information
to the third stimulator (140''). The third stimulator (140'') may
then use the measured information to adjust its stimulation
parameters and apply stimulation to a stimulation site accordingly
(e.g., to the occipital nerves). The various implanted stimulators
may, in any combination, sense indicators of the medical condition,
communicate or receive data on such indicators, and adjust
stimulation parameters accordingly.
[0076] Alternatively, the external device (250) or other external
devices communicating with the external device may be configured to
sense various indicators of a patient's condition. The sensed
indicators can then be collected by the external device (250) for
relay to one or more of the implanted stimulators or may be
transmitted directly to one or more of the implanted stimulators by
any of an array of external sensing devices. In either case, the
stimulator, upon receiving the sensed indicator(s), may adjust
stimulation parameters accordingly. In other examples, the external
controller (250) may determine whether any change to stimulation
parameters is needed based on the sensed indicators. The external
device (250) may then signal a command to one or more of the
stimulators to adjust stimulation parameters accordingly.
[0077] One of the difficulties that arises in using a stimulator
and a lead within a patient is determining the optimal stimulation
parameters for that patient, both initially and over time. In
particular, it is difficult to account for lead migration.
Implanted stimulators are implanted, generally, on a long-term or
permanent basis. However, with time and the natural movement of the
patient, a lead from an implanted stimulator tends to move away
from the location where it was first implanted. For example, a
simple nod of the head may cause the position of a lead that is
implanted in the neck to shift positions. This tendency is known as
lead migration, or simply, migration.
[0078] Unfortunately, as the lead moves or migrates, the stimulator
may continue to operate under the same stimulation parameters and
output the same stimulus. However, because the position of the
stimulator and/or its lead(s) has changed due to migration, the
resulting stimulation experienced by the patient will be different.
This may result due to a change in tissue impedance or distance or
orientation of the electrodes caused by migration relative to the
stimulation site. Consequently, lead migration may render the lead
unable to provide the optimal treatment with minimal power
consumption that was realized when the lead was more properly
positioned.
[0079] While efforts are made to avoid migration, adjustment in the
stimulation parameters as migration occurs may compensate for the
change in position and allow the stimulator to continue to provide
effective treatment. Hence, a number of methods and systems will be
described herein that may be used to determine the optimal
stimulation parameters for a particular patient at various points
in time.
[0080] The optimal stimulation parameters, including the optimal
electrode contact configuration, may vary depending on the
particular medical condition being treated, the time of day that
the stimulation is to be applied, and/or the requirements of the
stimulator itself. For example, the stimulation parameters may be
different during the day as opposed to during the night for a
particular patient. The stimulation parameters may also be
configured to optimize power consumption of the stimulator. Hence,
the methods and systems described herein may be used to
continuously identify and select optimal stimulation parameters as
best serves a particular application.
[0081] In some examples, as will be described in more detail below,
a technique known as "current steering" may be used to determine
the optimal stimulation parameters and compensate for lead
migration. Current steering is also know as neuronavigation or
e-trolling. As used herein and in the appended claims, the term
"current steering" will be used to describe a process used to
determine the optimal stimulation parameters for a particular
patient.
[0082] To facilitate an understanding of current steering, as
described herein, a number of exemplary electrode arrangements that
may be used in current steering will now be described in connection
with FIGS. 5A-5H. FIGS. 5A-5H illustrate a number of exemplary
electrode arrangements that may be a part of a stimulating lead
(141; FIG. 2) that is used to apply a stimulus at one or more
stimulation sites within a patient. Each of the electrode
configurations in FIGS. 5A-5H is disposed on a paddle portion (162)
of the lead (141; FIG. 2). The electrodes will also be referred to
herein and in the appended claims, unless otherwise specifically
denoted, as "electrode contacts" or simply "contacts."
[0083] The size and shape of the paddle (162), as opposed to a
thin, cylindrical lead, makes it less likely that the paddle (162)
will migrate or move away from the desired stimulation site once
implanted. Moreover, with time, tissue naturally begins to grow
around the implanted paddle (162), further securing the paddle
(162) in place. The paddle (162) may be coated with drugs that
encourage such tissue growth over and around the paddle (162) to
hold the paddle (162) in place. As will be appreciated, the size
and shape of the paddle (162) can be adjusted as best suits a
particular application or implantation environment.
[0084] The electrode contacts (142) on the paddle (162) may be
oriented on one or both side of the paddle (162) so as to direct
the stimulating current to the target stimulation site. Typically,
however, the contacts (142) will be arranged on one side of the
paddle (162) which is then implanted in an orientation with the
contacts (142) facing the tissue to be stimulated. As shown in
FIGS. 5A-5H, and as will be described in more detail below, the
electrode contacts (142) may be arranged in an array with a variety
of configurations to facilitate different types of stimulation or
provide different current steering effects.
[0085] For example, the stimulator (140; FIG. 2) may be configured
to provide monopolar and/or multipolar electrical stimulation at a
stimulation site via the electrode contacts (142). To this end,
each electrode contact (142) may be selectively programmed or
configured to act as an anode or as a cathode. Each electrode
contact (142) may also be programmed to be "off," i.e., not part of
the circuit deliver the stimulation current. Monopolar stimulation
is achieved by placing an electrode contact acting as a cathode (or
anode) adjacent to or near a stimulation site, and placing an
electrode of opposite polarity relatively "far away" from the
stimulation site. Bipolar stimulation is achieved by placing an
anode-cathode pair adjacent to or near a stimulation site. Tripolar
stimulation is achieved by placing a cathode surrounded by two
anodes or an anode surrounded by two cathodes adjacent to or near a
stimulation site.
[0086] Monopolar and multipolar electrode configurations have
different stimulation properties. For example, as illustrated in
FIG. 6, relative current threshold values vary as a function of
distance from the stimulation site for each of these electrode
configurations. As used herein and in the appended claims, the term
"current threshold value" will be used to refer to the minimum
amount of current required to stimulate, e.g., evoke a tissue
response from, a stimulation site. FIG. 6 is a graph illustrating
the relative current threshold values of monopolar, bipolar, and
tripolar electrode configurations as a function of distance from
the stimulation site. The graph is based on a theoretical
mathematical model of neural stimulation. The current threshold
values are normalized by the current threshold of the monopolar
configuration.
[0087] As shown in FIG. 6, when the stimulation site is relatively
near the stimulating lead (141; FIG. 2), lower stimulation
thresholds may be achieved with a properly spaced bipole or tripole
electrode configuration than with a monopole electrode
configuration. However, as the distance between the stimulation
site and the stimulating lead (141; FIG. 2) increases, the
thresholds for the bipolar and tripolar electrode configurations
begin to exceed that of the monopolar electrode configuration.
Thus, monopolar stimulation is often used when the stimulation site
is relatively "far" from the stimulating lead (141; FIG. 2) and
multipolar stimulation is often used when the stimulation site is
relatively "close" to the stimulating lead (141; FIG. 2).
[0088] Monopolar and multipolar electrode configurations often have
different stimulation localization properties. For example, a
monopolar electrode configuration emits a multidirectional
electrical field that may be used to stimulate a relatively general
stimulation site. A multipolar electrode configuration, on the
other hand, emits a more localized electrical field that is often
used to stimulate a relatively specific stimulation site, and may
be used to stimulate stimulation sites that have a particular
orientation (e.g., a nerve).
[0089] Returning to FIGS. 5A-5H, the electrode contacts (142) may
be made of any conducting material that will withstand and operate
effectively in an implanted environment. Such materials include,
for example, a conducting ceramic, conducting polymer, copper,
and/or a noble or refractory metal, such as gold, silver, platinum,
iridium, tantalum, titanium, titanium nitride, niobium, and/or an
alloy thereof. The use of one or more of these materials in
constructing the electrode contacts (142) may serve to minimize
corrosion, electrolysis, and/or damage to surrounding tissues.
[0090] The surfaces of the electrode contacts (142) may have any of
a number of properties. For example, the surfaces may be smooth or
rough. A rough surface increases the actual surface area of an
electrode contact and may, with some materials (e.g., platinum or
iridium), increase the pseudo-capacitance of the electrode contact.
An increased pseudo-capacitance may serve to minimize the risk of
adverse electrical affects to a patient being treated. A rough
surface may also serve to minimize lead migration.
[0091] Moreover, the electrode contacts (142) may have any suitable
size or shape. Differently shaped electrode contacts (142) provide
different current densities. For example, a round or oval electrode
contact, as shown in FIGS. 5A-5H, may provide a more uniform
current density than an electrode contact that is rectangular.
However, the shape of the electrode contacts (142) may vary as best
serves a particular application.
[0092] As mentioned, the electrode contacts (142) may be arranged
in a variety of array configurations to facilitate different types
of stimulation. FIGS. 5A-5H illustrate a number of exemplary
electrode contact arrangements that may be used to provide
monopolar and/or multipolar stimulation at a stimulation site.
However, it will be recognized that the electrode contact
arrangements shown in FIGS. 5A-5H are merely illustrative of the
many different electrode contact arrangements that may be used to
provide monopolar and/or multipolar stimulation at a stimulation
site.
[0093] For example, FIG. 5A shows a first electrode contact
arrangement that may be used to provide monopolar and/or multipolar
stimulation at a stimulation site. The electrode contact
arrangement of FIG. 5A includes a center electrode contact (142-1)
surrounded by three electrode contacts (142-2,3,4) in an
equilateral triangle or trigonal planar configuration. As
mentioned, each of the electrode contacts (142) may be selectively
configured to act as an anode or cathode. Hence, monopolar
stimulation may be achieved by using, for example, the top
electrode contact (142-2) and one of the bottom electrode contacts
(e.g., 142-3) as an anode-cathode pair. Bipolar stimulation may be
achieved by using, for example, the center electrode contact
(142-1) with one of the other electrode contacts (e.g., 142-2) as
an anode-cathode pair. Tripolar stimulation may be achieved by
using, for example, the center electrode contacts (142-1) with two
of the other electrode contacts (e.g., 142-3 and 142-4) in an
anode-cathode-anode or cathode-anode-cathode configuration.
[0094] As illustrated in FIGS. 5A-5H, there are many possible
configurations for the electrode contact array. The illustrated
examples are merely exemplary and other configurations are within
the scope of the principles described herein. FIG. 5B illustrates a
configuration with a central electrode contact (142) and four
additional electrode contacts (142) arranged in a square around the
central electrode contact (142). The four additional electrode
contacts (142) may be located at the corners of a square paddle
lead as shown in FIG. 5B. FIG. 5C illustrated a line of four
electrode contacts (142) with a line of two electrode contacts
(142) both above and below the line of four, with the lines of two
electrode contacts (142) each being centered with respect to the
larger line of four. FIG. 5D illustrates a similar configuration
only with two lines of four electrode contacts (142) arranged
between the upper and lower lines of two.
[0095] FIG. 5E illustrates a configuration in which the electrode
contacts (142) are arranged in a two-by-four rectangular array.
FIG. 5F illustrates a configuration in which a line of four
electrodes is disposed adjacent a line of three electrodes, both
lines being centered with respect to a rectangular paddle. FIG. 5G
illustrated a configuration with six electrode contacts (142) in
three columns of two electrode contacts (142) each. The center
column is offset vertically with respect to the two side columns.
FIG. 5H illustrates a configuration in which the electrode contacts
(142) are arranged in a circle or ring pattern. Each configuration
illustrated and other possible configurations for the electrode
contacts (142) will provide different current steering options and
may be particularly well suited to treating a particular condition
or patient.
[0096] As mentioned, current steering may be used to determine the
optimal stimulation parameters for a particular patient. FIG. 7 is
a flow chart illustrating an exemplary method of current steering
that may be used to determine the optimal stimulation parameters
for a particular patient. The steps shown in FIG. 7 are merely
illustrative and may be modified, reordered, or removed as best
serves a particular application. Moreover, the steps shown in FIG.
7 may be performed by a processor or the like via a set of computer
readable instructions. These computer readable instructions may be
constructed in any programming language, such as Java or C, for
example, and stored on any medium configured to store computer
readable instructions such as a flash drive, memory chip, compact
disk (CD), digital versatile disc (DVD), floppy disk, or hard
drive, for example.
[0097] As shown in FIG. 7, one or more of the electrode contacts
(142; FIGS. 5A-5H) are programmed to act as anodes (step 700). One
or more of the electrode contacts (142; FIGS. 5A-5H) are also
programmed to act as cathodes (step 701). It is also possible that
one or more of the electrode contacts are programmed to be
"off."
[0098] Any of the other stimulation parameters may also be adjusted
(step 702). For example, the frequency, pulse width, amplitude,
burst pattern (e.g., burst on time and burst off time), duty cycle
or burst repeat interval, ramp on time, and/or ramp off time of the
stimulation current applied by each of the electrode contacts (142;
FIGS. 5A-5H) may be adjusted.
[0099] Once all of the electrode contacts (142; FIGS. 5A-5H) have
been programmed and the other stimulation parameters adjusted, a
stimulation current is generated by the stimulator (140; FIG. 2)
and applied via the electrode contacts (142; FIGS. 5A-5H) (step
703). The process is repeated until it is determined that the
stimulation is optimal (Yes; step 704). Exemplary methods for
determining when the stimulation is optimized will be described
below. In some examples, the process is repeated until all possible
combinations of anode and cathode assignments are tested.
[0100] A number of techniques may be used to determine whether the
stimulation applied by the electrode contacts (142; FIGS. 5A-5H) is
optimal (step 704). In some examples, patient feedback may be used
to determine the optimal stimulation parameters. For example, if
the stimulation is being applied to a nerve (e.g., the greater or
lesser occipital nerves) to treat chronic headache pain, the
stimulation parameters may be adjusted until the patient indicates
that the greatest amount of relief from the headache pain has been
achieved. Alternatively, a neural response to a particular set of
stimulation parameters may be measured by a recording electrode or
other device. The stimulation parameters may be adjusted until an
optimal neural response is measured. Any other method may be used
as best serves a particular application to determine the optimal
stimulation parameters.
[0101] The current steering method described in connection with
FIG. 7 may be performed automatically with a computerized
programming station or another suitable programming device. The
programming device may include a self-contained hardware/software
system, or it may include software running on a standard personal
computer (PC). Exemplary programming devices include, but are not
limited to, the clinician programming system (157; FIG. 2) and the
hand held programmer (155; FIG. 2) described above. The programming
device may include a transmitting coil attachment configured to
communicate with the implanted stimulator (140; FIG. 2).
Alternatively, the programming device may be included within the
stimulator (140; FIG. 2) itself.
[0102] Alternatively, the current steering method may be performed
manually. For example, a physician or patient may manually steer
the current with the aid of a computer, hand-held programmer,
joystick, or other device.
[0103] A simplified example of current steering will now be given
in connection with FIGS. 8A-8C. FIGS. 8A-8C include the exemplary
electrode arrangement of FIG. 5A. As will be described in
connection with these figures, the current may be steered in a
clockwise path to find the best cathode-anode combination for a
particular patient.
[0104] A simplified example of current steering will now be given
in connection with FIGS. 8A-8C. FIGS. 8A-8C include the exemplary
electrode arrangement of FIG. 5A. As will be described in
connection with these figures, the current may be steered in a
clockwise path to find the best cathode-anode combination for a
particular patient.
[0105] As shown in FIG. 8A, the center electrode contact (142-1) is
initially programmed as an anode (+) and the top electrode contact
(142-2) is initially programmed as a cathode (-). The bottom
electrode contacts (142-3,4) are programmed to be off. Hence, the
stimulation current flows from the center electrode contact (142-1)
to the top electrode contact (142-2) and creates an electric field
E.sub.1, as shown in FIG. 8A.
[0106] The top electrode contact (142-2) is then turned off and the
bottom right electrode contact (142-4) is programmed to act as a
cathode (-), as shown in FIG. 8B. The current now flows from the
center electrode contact (142-1) to the bottom right electrode
contact (142-4), as indicated by the arrow labeled E.sub.2.
[0107] The bottom right electrode contact (142-4) is then turned
off and the bottom left electrode contact (142-3) is programmed to
act as a cathode (-), as shown in FIG. 8C. The resulting current
flow, E.sub.3, is now between the center electrode contact (142-1)
and the bottom left electrode contact (142-3).
[0108] This process may be repeated with some or all of the other
combinations of anodes and cathodes until the optimal cathode-anode
configuration is found. It will be recognized that the current may
be steered in any path as best serves a particular application and
that other stimulation parameters (e.g., frequency, pulse width,
amplitude, burst pattern (e.g., burst on time and burst off time),
duty cycle or burst repeat interval, ramp on time, and/or ramp off
time) may additionally or alternatively be adjusted to determine
the optimal stimulation parameters for a particular
application.
[0109] A number of alternative current steering techniques may be
used in connection with the present methods and systems described
herein. For example, an exemplary current steering method is
disclosed in U.S. Pat. No. 6,393,325, which is incorporated herein
by reference in its entirety.
[0110] In some examples, the current steering methods and systems
described herein are used when the lead (141; FIG. 2) and
stimulator (140; FIG. 2) are initially implanted within the patient
to determine the initial stimulation parameters that are best
suited for the particular patient. Additionally or alternatively,
the current steering methods and systems described herein may be
used subsequently to account for lead migration and other changes
within the patient that may occur after implantation.
[0111] The methods and systems described herein are particularly
useful in stimulating nerves within the head or neck to treat
headache pain and/or other medical conditions. However, it will be
recognized that the methods and systems described herein may be
used to stimulate any stimulation site within the patient to treat
any medical condition.
[0112] As mentioned, the stimulator (140; FIG. 2) may be configured
to additionally or alternatively infuse one or more drugs at the
stimulation site. In some examples, the one or more drugs may have
charges that are attracted to or repelled by the electrode contacts
acting as anodes and cathodes. For example, a drug having a
positive charge may be attracted to a cathode having a negative
charge and repelled by an anode having a positive charge. Hence, in
some examples, a drug may be steered to a particular stimulation
site by appropriately programming the electrode contacts to have
positive or negative charges.
[0113] The preceding description has been presented only to
illustrate and describe embodiments of the invention. It is not
intended to be exhaustive or to limit the invention to any precise
form disclosed. Many modifications and variations are possible in
light of the above teaching.
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