U.S. patent application number 11/300963 was filed with the patent office on 2007-06-21 for apparatus and methods for stimulating tissue.
Invention is credited to Kerry Bradley.
Application Number | 20070142863 11/300963 |
Document ID | / |
Family ID | 38174715 |
Filed Date | 2007-06-21 |
United States Patent
Application |
20070142863 |
Kind Code |
A1 |
Bradley; Kerry |
June 21, 2007 |
Apparatus and methods for stimulating tissue
Abstract
Apparatus and methods for stimulating tissue employing local
current imbalance to facilitate more effective stimulation
regimens.
Inventors: |
Bradley; Kerry; (Glendale,
CA) |
Correspondence
Address: |
Vista IP Law Group LLP
2040 MAIN STREET, 9TH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
38174715 |
Appl. No.: |
11/300963 |
Filed: |
December 15, 2005 |
Current U.S.
Class: |
607/2 |
Current CPC
Class: |
A61N 1/36125 20130101;
A61N 1/36185 20130101; A61N 1/0553 20130101; A61N 1/36071 20130101;
A61N 1/0529 20130101; A61N 1/0551 20130101 |
Class at
Publication: |
607/002 |
International
Class: |
A61N 1/18 20060101
A61N001/18 |
Claims
1. A method, comprising the steps of: generating action potentials
in neural fibers in first and second neural fiber bundles with a
first electrode that is a first distance from the first neural
fiber bundle and is a second distance, that is greater than the
first distance, from the second neural fiber bundle; and blocking
at least some of the action potentials in the first neural fiber
bundle with a second electrode that is the first distance from the
first neural fiber bundle and the second distance from the second
neural fiber bundle.
2. A method as claimed in claim 1, wherein generating action
potentials comprises sinking a portion of current from the second
electrode at the first electrode; and further comprising the step
of: sinking another portion of the current from the second
electrode at a remote electrode.
3. A method as claimed in claim 1, wherein blocking at least some
of the action potentials comprises blocking at least some of the
action potentials in the first neural fiber bundle with second and
third electrodes that are each the first distance from the first
neural fiber bundle and the second distance from the second neural
fiber bundle and are located on opposite sides of the first
electrode.
4. A method as claimed in claim 3, wherein generating action
potentials comprises sinking a portion of current from the second
and third electrodes at the first electrode; and further comprising
the step of: sinking another portion of the current from the second
and third electrode at a remote electrode.
5. A neurostimulation system for use with a first implantable lead
including a plurality of lead electrodes, the neurostimulation
system comprising: an implanted pulse generator (IPG) including a
lead connector; circuitry, operably connected to the lead
connector, to generate electrical waveforms that create action
potentials in neural fibers in first and second neural fiber
bundles with a first lead electrode, the first neural fiber bundle
being a first distance from the first implantable lead and the
second neural fiber bundle being a second distance, that is greater
than the first distance, from the first implantable lead; and
circuitry, operably connected to the lead connector, that generates
electrical waveforms to block at least some of the action
potentials in the first neural fiber bundle with a second lead
electrode.
6. A neurostimulation system as claimed in claim 5, further
comprising a remote electrode; wherein the circuitry generating
electrical waveforms to block at least some of the action
potentials comprises circuitry to source current at the second lead
electrode; and wherein the circuitry to generate electrical
waveforms to create action potentials comprises circuitry to sink a
portion of the current from the second lead electrode at the first
lead electrode and to sink a portion of the current from the second
lead electrode at the remote electrode.
7. A neurostimulation system as claimed in claim 5, wherein the IPG
includes a case electrode; the circuitry generating electrical
waveforms to block at least some of the action potentials comprises
circuitry to source current at the second lead electrode; and the
circuitry to generate electrical waveforms to create action
potentials comprises circuitry to sink a portion of the current
from the second lead electrode at the first lead electrode and to
sink a portion of the current from the second lead electrode at the
case electrode.
8. A neurostimulation system as claimed in claim 5, wherein the
circuitry generating electrical waveforms to block at least some of
the action potentials comprises circuitry to generate electrical
waveforms to block at least some of the action potentials in the
first neural fiber bundle with second and third lead electrodes
located on opposite sides of the first lead electrode.
9. A neurostimulation system as claimed in claim 8, wherein the
circuitry generating electrical waveforms to block at least some of
the action potentials comprises circuitry to source current at the
second and third lead electrodes; and the circuitry to generate
electrical waveforms to create action potentials comprises
circuitry to sink a portion of the current from the second and
third lead electrodes at the first lead electrode and to sink a
portion of the current from the second and third lead electrodes at
a remote electrode.
10. A neurostimulation system as claimed in claim 8, wherein the
IPG includes a case electrode; the circuitry generating electrical
waveforms to block at least some of the action potentials comprises
circuitry to source current at the second and third lead
electrodes; and the circuitry to generate electrical waveforms to
create action potentials comprises circuitry to sink a portion of
the current from the second and third lead electrodes at the first
lead electrode and to sink a portion of the current from the second
and third lead electrodes at the case electrode.
11. A neurostimulation system for use with a first implantable lead
including a plurality of lead electrodes, the neurostimulation
system comprising: an implanted pulse generator (IPG) including a
lead connector and a case electrode; circuitry, operably connected
to the lead connector, to source current at a first lead electrode;
and circuitry, operably connected to the lead connector and the
case electrode, to sink a portion of the current from the first
lead electrode at a second lead electrode and to sink a portion of
the current from the first lead electrode at the case
electrode.
12. A neurostimulation system as claimed in claim 11, wherein the
circuitry to source current comprises circuitry to source current
at first and third lead electrodes located on opposite sides of the
second lead electrode; and the circuitry to sink current comprises
circuitry to sink a portion of the current from the first and third
lead electrodes at the second lead electrode and to sink another
portion of the current from the first and third lead electrodes at
the case electrode.
13. A neurostimulation system as claimed in claim 12, wherein the
circuitry to source current comprises circuitry to source equal
amounts of current at the first and third lead electrodes.
14. A method, comprising the steps of: sourcing current into neural
tissue with a first electrode on an implantable lead; sinking a
portion of the current from the first electrode at a second
electrode on the implantable lead; and sinking another portion of
the current from the first electrode at a remote electrode.
15. A method as claimed in claim 14, wherein sourcing current into
neural tissue comprises sourcing current into neural tissue with
first and third electrodes located on the implantable lead and on
opposite sides of the second electrode.
16. A method as claimed in claim 15, wherein all of the current
sourced at the first and third electrodes is sunk at the second
electrode and the remote electrode.
17. A method as claimed in claim 14, wherein sinking a portion of
the current from the first electrode at a second electrode
comprises sinking current sufficient to generate action potentials
in the neural tissue at the second electrode.
18. A method as claimed in claim 14, wherein sourcing current into
neural tissue with first electrode comprises sourcing current
sufficient to block action potentials at the first electrode.
19. A method as claimed in claim 14, wherein sinking another
portion of the current from the first electrode comprises sinking
another portion of the current from the first electrode at a case
electrode.
20. A method as claimed in claim 14, wherein the neural tissue
comprises elongate fibers, the method further comprising the step
of: orienting the implantable lead transverse to the elongate
fibers.
Description
BACKGROUND OF THE INVENTIONS
[0001] 1. Field of Inventions
[0002] The present inventions relate generally to neurostimulation
systems.
[0003] 2. Description of the Related Art
[0004] Neurostimulation systems, such as spinal cord stimulation
(SCS) systems, deep brain stimulation systems and peripheral nerve
stimulation systems, include at least one electrode positioned to
enable stimulation of neural elements that are the target tissue
(i.e. the tissue that, when sufficiently stimulated, will create
the desired therapeutic effect). The electrodes are commonly
mounted on a carrier and, in many instances, a plurality of
electrodes are mounted on a single carrier. These carrier/electrode
devices are sometimes referred to as "leads". The electrodes may be
used to cause nerves to fire action potentials (APs) that propagate
along the neural fibers. More specifically, supplying stimulation
energy to an electrode functioning as a cathode creates an electric
potential field that causes depolarization of the neurons adjacent
to the electrode. When the field is strong enough to depolarize (or
"stimulate") the neurons beyond a threshold level, the neurons will
fire APs.
[0005] Stimulation energy may be delivered to the electrodes during
and after the lead placement process in order to verify that the
electrodes are stimulating the target neural elements and to
formulate the most effective stimulation regimen. The regimen will
dictate which of the electrodes are sourcing or returning current
pulses at any given time, as well as the magnitude and duration of
the current pulses. The stimulation regimen will typically be one
that provides stimulation energy to all of the target tissue that
must be stimulated in order to provide the therapeutic benefit
(e.g., pain relief), yet minimizes the volume of non-target tissue
that is stimulated. Thus, certain types of neurostimulation leads
are typically implanted with the understanding that the stimulus
pattern will require fewer than all of the electrodes on the leads
to achieve the desired clinical effect; in the case of SCS, such a
clinical effect is "paresthesia," i.e., a tingling sensation that
is effected by the electrical stimuli applied through the
electrodes.
[0006] The present inventor has determined that conventional
stimulus regimens, and the manner in which they are formulated, may
be susceptible to improvement. For example, there are instances
where the target tissue is not directly adjacent to an electrode
and, because electrical field strength decreases exponentially with
distance from the electrode, a relatively strong electric field
must be created to generate APs in the target neural fibers. The
electric field may, however, result in the generation of APs in the
non-target fiber bundles between the electrode and the target
fibers. The generation of APs in the non-target tissue may, in
turn, lead to undesirable outcomes (e.g., discomfort) for the
patient. The present inventor has determined that it may also be
desirable in, for example, the context of leads that are oriented
transverse to the target neural fibers, to selectively control the
shape of the AP generating region in order to prevent the
generation of APs in non-target fibers.
SUMMARY OF THE INVENTIONS
[0007] Apparatus and methods in accordance with some of the present
inventions involve the creation of APs in neural fibers and the
selective blocking of the APs in some of the neural fibers in which
APs are created. Such apparatus and methods are advantageous for a
variety of reasons. For example, such apparatus and methods
facilitate stimulation regimens that create APs in tissue that is
not directly adjacent to the depolarizing electrode(s) while
preventing APs from propagating in the tissue therebetween that
produce undesirable outcomes for the patient.
[0008] Apparatus and methods in accordance with some of the present
inventions involve the use of local current imbalances and the
sinking of current at a remote cathode(s). Such apparatus and
methods are advantageous for a variety of reasons including, but
not limited to, facilitation of the selective control of the width
and depth of AP generating regions. For example, the programmer may
increase the current sourced at one or more electrodes within the
stimulation site, which tends to reduce the width of the AP
generating and propagating region, without a corresponding increase
in the current sunk at one or more other electrodes within the
stimulation site (which would increase the depth of the AP
generating region).
[0009] The above described and many other features of the present
inventions will become apparent as the inventions become better
understood by reference to the following detailed description when
considered in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] Detailed description of exemplary embodiments of the
inventions will be made with reference to the accompanying
drawings.
[0011] FIG. 1 is a side view of a neurostimulation system in
accordance with one embodiment of a present invention.
[0012] FIG. 2 is an end view of an implantable pulse generator in
accordance with one embodiment of a present invention.
[0013] FIG. 3 is a plan view of a lead in accordance with one
embodiment of a present invention.
[0014] FIG. 4 is a functional block diagram of an implantable pulse
generator in accordance with one embodiment of a present
invention.
[0015] FIG. 5 is a diagram showing a stimulation regimen that may
be produced by the implantable pulse generator illustrated in FIG.
1.
[0016] FIG. 6 is a diagram showing another stimulation regimen that
may be produced by the implantable pulse generator illustrated in
FIG. 1.
[0017] FIG. 7 is an illustration of a stimulation pulse that may be
produced by the implantable pulse generator illustrated in FIG.
1.
[0018] FIG. 8 is an illustration of another stimulation pulse that
may be produced by the implantable pulse generator illustrated in
FIG. 1.
[0019] FIG. 9 is a functional block diagram of an implantable pulse
generator in accordance with one embodiment of a present
invention.
[0020] FIG. 10 is a graph of the changes in neural fiber
transmembrane potential that results from a conventional
neurostimulation regimen.
[0021] FIG. 11 is a graph of the changes in neural fiber
transmembrane potential that results from another conventional
neurostimulation regimen.
[0022] FIG. 12 is a graph of the changes in neural fiber
transmembrane potential that results from a neurostimulation
regimen in accordance with one embodiment of a present
invention.
[0023] FIG. 13 is a graph of the changes in neural fiber
transmembrane potential that results from a neurostimulation
regimen in accordance with one embodiment of a present
invention.
[0024] FIG. 14 is a section view of a dorsal column being treated
with a conventional neurostimulation regimen.
[0025] FIG. 15 is a section view of a dorsal column being treated
with a neurostimulation regimen in accordance with one embodiment
of a present invention.
[0026] FIG. 16 is a section view of a dorsal column being treated
with a neurostimulation regimen in accordance with one embodiment
of a present invention.
[0027] FIG. 17 is a flow chart summarizing various processes in
accordance with the present inventions.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0028] The following is a detailed description of the best
presently known modes of carrying out the inventions. This
description is not to be taken in a limiting sense, but is made
merely for the purpose of illustrating the general principles of
the inventions. The detailed description is organized as
follows:
[0029] I. Exemplary Neurostimulation Systems
[0030] II. Exemplary Neurostimulation Regimens
The section titles and overall organization of the present detailed
description are for the purpose of convenience only and are not
intended to limit the present inventions.
I. Exemplary Neurostimulation Systems
[0031] The present inventions have application in a wide variety of
neurostimulation systems. Although the present inventions are not
so limited, examples of such systems are illustrated in FIGS. 1-9.
Referring first to FIGS. 1 and 2, an exemplary implantable
neurostimulation system 100 includes first and second implantable
leads 102 and 104. The exemplary leads 102 and 104 are in-line
leads and, to that end, both of the leads consist of a plurality of
in-line electrodes 106 carried on a flexible body 108. In the
illustrated embodiment, there are eight (8) electrodes on lead 102,
which are labeled E1-E8, and there are eight (8) electrodes on lead
104, which are labeled E9-E16. The actual number of leads and
electrodes will, of course, vary according to the intended
application and the present inventions are not limited to any
particular numbers of leads and electrodes. The implantable
neurostimulation system 100 may, alternatively, employ other types
of leads such as, for example, the paddle lead 102a with electrodes
106a on a wide platform 108a illustrated in FIG. 3. In any case,
the leads may be implanted into a desired location, such as
adjacent to the patient's spinal cord, through the use of an
insertion needle or other conventional techniques. Once in place,
the electrodes may be used to supply stimulation energy to the
target neural elements or other target tissue.
[0032] The exemplary neurostimulation system 100 illustrated in
FIGS. 1 and 2 also includes an implantable pulse generator (IPG)
110 that is capable of directing stimulation energy to each of the
electrodes 106. The stimulation energy may be stimulation energy
waveforms such as, for example, pulses having various shapes and
sine waves. To that end, each of the electrodes 106 on the lead 102
is electrically connected to the IPG 110 by a respective signal
wire 112 (some of which are not shown) that extends through, or is
imbedded in, the associated flexible body 108. Similarly, the
electrodes 106 on the lead 104 are electrically connected to the
IPG 110 by respective signal wires 114 (some of which are not
shown). The signal wires 112 and 114 are connected to the IPG 110
by way of an interface 116. The interface 116 may be any suitable
device that allows the leads 102 and 104 to be removably or
permanently electrically connected to the IPG 110. Such an
interface may, for example, be an electro-mechanical connector
arrangement including lead connectors 118a and 118b within the IPG
110 that are configured to mate with corresponding connectors on
the leads 102 and 104 (only connector 120a on lead 102 is shown).
Alternatively, the leads 102 and 104 can share a single connector
that mates with a corresponding connector on the IPG. Exemplary
connector arrangements are disclosed in U.S. Pat. Nos. 6,609,029
and 6,741,892, which are incorporated herein by reference.
[0033] The exemplary IPG 110 includes an outer case 122 that may be
formed from an electrically conductive, biocompatible material such
as titanium and, in some instances, will function as an electrode.
The IPG 110 is typically programmed, or controlled, through the use
of an external (non-implanted) programmer 124. The external
programmer 124 is coupled to the IPG 110 through a suitable
communications link, represented by the arrow 126, that passes
through the patient's skin 128. Suitable links include, but are not
limited to, radio frequency (RF) links, inductive links, optical
links and magnetic links. The programmer 124 or other external
device may also be used to couple power into the IPG 110 for the
purpose of operating the IPG or replenishing a power source, such
as a rechargeable battery, within the IPG. Once the IPG 110 has
been programmed, and its power source has been charged or otherwise
replenished, the IPG may function as programmed without the
external programmer 124 being present.
[0034] With respect to the stimulus regimens provided during
operation of the exemplary neurostimulation system 100, electrodes
that are selected to receive stimulation energy are referred to
herein as "activated," while electrodes that are not selected to
receive stimulation energy are referred to herein as
"non-activated." Electrical stimulation will occur between two (or
more) electrodes, one of which may be the IPG case, so that the
electrical current associated with the stimulus has a path through
the tissue from one or more electrodes configured as anodes to one
or more electrodes configured as cathodes, or return electrodes.
The return electrode(s) may be one or more of the electrodes 106 on
the leads 102 and 104 or may be the IPG case 122. Stimulation
energy may be transmitted to the tissue in monopolar, bipolar, or
multipolar fashion, as examples. Monopolar stimulation occurs when
a selected one of the lead electrodes 106 is activated along with
the case 122. Bipolar stimulation occurs when two of the lead
electrodes 106 are activated. The lead electrodes 106 may be on the
same lead, or on different leads. For example, electrode E3 on lead
102 may be activated as an anode at the same time that electrode E4
on lead 102, or electrode E11 on lead 104, is activated as a
cathode. Tripolar stimulation occurs when three of the lead
electrodes 106 are activated on the same lead, or on different
leads. For example, electrodes E4 and E6 on lead 102 may be
activated as anodes at the same time that electrode E5 on lead 102,
is activated as a cathode. Generally speaking, multipolar
stimulation occurs when multiple lead electrodes 106 are
activated.
[0035] Turning to FIG. 4, an exemplary IPG 110 has a plurality of
dual current sources 130. Each dual current source 130 includes a
positive current source that can function as an anode (+I1, +I2,
+I3, . . . +Icase) to "source" current to a load, as well as a
current source that can function as a cathode (-I1, -I2, -I3, . . .
-Icase) to "sink" current from the load, through a common node 132.
The load is the tissue that resides between the activated
electrodes 106, the wires (and other conductive elements), and the
coupling capacitor (C1, C2, C3, . . . Ccase) that connects the
associated electrode to the common node 132 of the dual current
source 130.
[0036] The IPG programming will dictate which of the electrodes,
i.e. the lead electrodes 106 and the IPG case 122, will act as
source(s) and sink(s) at any particular time. To that end, the IPG
110 is provided with a programmable current control circuit 134
that causes selected dual current sources 130 to operate as an
anode or a cathode, at specified times, to source or sink current
having predetermined amplitude (and other parameters). In the
illustrated embodiment, where there are eight (8) electrodes 106 on
lead 102 (labeled E1-E8), eight (8) electrodes on lead 104
(E9-E16), and an IPG case 122 that can function as an electrode
(labeled Ecase), there are seventeen individually operable dual
current sources 130. The control circuit 134, which typically
operates in accordance with stored control data that is received
from the programmer 124, also turns off the selected dual current
sources 130 at specified times. Alternative implementations may,
for instance, employ fewer dual current sources than there are
electrodes. Here, at least some of the dual current sources will be
connected to more than one electrode. Alternative implementations
may also be configured such that the IPG case 122 only functions as
an anode, or such that the IPG case only functions as a cathode
[0037] The operation of the control circuit 134 may be explained in
the context of the following example. Referring to FIG. 5, the
control circuit 134 may be used to simultaneously turn on (or
enable) the positive current sources in the dual current sources
130 connected to lead electrodes E1 and E3 during time T1. The
negative current source in the dual current source 130 connected to
lead electrode E2 is also turned on during time T1. All other
current sources are off (or disabled) during the time T1. This
causes electrodes E1 and E3 to be activated as anodes at the same
time that electrode E2 is activated as a cathode. Currents +I1 and
+I3 are sourced from electrodes E1 and E3 at the same time that
current -I2 is sunk into electrode E2. The amplitudes of the
currents +I1 and +I3 may be any programmed values, and the
amplitude of the current -I2 will be equal to -(I1+I3). That is,
the current that is sourced from electrodes E1 and E3 is equal to
the current that is sunk at electrode E2. Sinking all of the
current sourced into the target tissue region at the target tissue
region is referred to herein as "local current balance." As used
herein, "local" electrodes are electrodes that, when sourcing or
sinking stimulation current in the vicinity of the target tissue,
have a clinically significant neuromodulatory effect on the target
tissue.
[0038] As another example, the control circuit 134 may be used to
cause a portion of the current sourced from one or more lead
electrodes to be sunk by one (or more) lead electrodes and the
remainder of the current to be sunk at the IPG case. Turning to
FIG. 6, and for reasons that are discussed in greater detail below
with reference to FIGS. 12, 13, 15 and 16, the control circuit 134
may be used to simultaneously turn on (or enable) the positive
current sources in the dual current sources 130 connected to lead
electrodes E1 and E3 during time T1. The negative current sources
in the dual current source 130 connected to lead electrode E2 and
case electrode Ecase are also turned on during time T1. All other
current sources are off (or disabled) during the time T1. This
causes electrodes E1 and E3 to be activated as anodes at the same
time that electrodes E2 and Ecase are activated as cathodes.
Currents +I1 and +I3 are sourced from electrodes E1 and E3 at the
same time that current -I2 and -Icase is sunk into electrodes E2
and Ecase. The amplitudes of the currents +I1 and +I3 may be any
programmed values, while the sum of the amplitudes of the currents
-I2 and -Icase will be equal to -(I1+I3), i.e., -I2 will be equal
to A% of -(I1+I3) and -Icase will be equal to B% of -(I1 +I3),
where A% +B% =100%. That is, the sum of the current that is sourced
from electrodes E1 and E3 is equal to the sum of the current that
is sunk at electrodes E2 and Ecase. Sinking a portion of the
current sourced into the target tissue region at a remote location,
such as at the case electrode Ecase, is referred to herein as
"local current imbalance." As used herein, a "remote" electrode is
an electrode that, when sourcing or sinking stimulation current,
will not have a clinically significant neuromodulatory effect on
the target tissue other than reducing the amount of current sourced
or sunk at the target tissue.
[0039] After time period T1, the control circuit 134 will typically
switch the polarities of the electrodes during a second time period
T2. Thus, an electrode that was functioning as an anode during time
period T1 will function as a cathode during time period T2, and an
electrode that was functioning as a cathode during time period T1
will function as an anode during time period T2. Operating the
control circuit 134 in this manner produces a biphasic stimulation
pulse that is characterized by a first phase (period T1) of one
polarity followed by a second phase immediately or shortly
thereafter (period T2) of the opposite polarity. The electrical
charge associated with the first phase should be equal to the
charge associated with the second phase to maintain charge balance
during the stimulation, which is generally considered an important
component of stimulation regimes, although this is not required by
the present inventions. Referring to FIG. 7, the charge balance of
a biphasic stimulation pulse 136 may be achieved by making the
amplitudes of the first and second phases, as well as the periods
T1 and T2, substantially equal. Charge balance may also be achieved
using other combinations of phase duration and amplitude. For
example, the amplitude of the second phase may be equal to one-half
of the amplitude of the first phase and the period T2 may be equal
to twice the period T1, as is the case in the biphasic stimulation
pulse 136' illustrated in FIG. 8.
[0040] Neurostimulation systems in accordance with the present
inventions may also employ the alternative IPG 110' illustrated in
FIG. 9, which includes a plurality of dual voltage sources 130'
that are respectively connected to the lead electrodes E1-E16 and
the IPG case electrode Ecase. Each dual voltage source 130' applies
a programmed voltage to the associated electrode when turned on by
way of a node 132' and a coupling capacitor (C1, C2, C3, . . . .
Ccase). Alternative implementations may, as an example, employ
fewer dual voltage sources than there are electrodes. Here, at
least some of the dual voltage sources will be connected to more
than one electrode. A programmable voltage control circuit 134'
controls each of the dual voltage sources 130' and specifies the
amplitude, polarity and duration of the voltage that is applied to
the electrodes.
[0041] The dual voltage sources 130' and control circuit 134' may
be used to produce the biphasic stimulation pulses that are
characterized by a first phase (period T1) of one polarity followed
by a second phase immediately or shortly thereafter (period T2) of
the opposite polarity applied between any two or more electrodes.
Charge balance of the biphasic stimulation pulse may be achieved by
making the amplitudes of the first and second phases, as well as
the periods T1 and T2, equal. Charge balance may also be achieved
using other combinations of phase duration and amplitude. For
example, the amplitude of the second phase may be equal to one-half
of the amplitude of the first phase and the period T2 may be equal
to twice the period T1.
[0042] Additional details concerning IPGs may be found in U.S. Pat.
No. 6,516,227 and U.S. Pub. App. 2003/0139781, which are
incorporated herein by reference. It also should be noted that the
block diagrams illustrated in FIGS. 4 and 9 are functional
diagrams, and are not intended to limit the present inventions to
any particular IPG circuitry.
[0043] The present inventions also have application in
non-implantable neurostimulation systems. For example, the present
inventions may be embodied in, and/or performed using,
transcutaneous electrical nerve stimulation ("TENS") systems. In
TENS systems, the sourcing and sinking electrodes are placed on the
patient's skin. Current is sourced into the neural tissue by way of
the skin. Current is also sunk, both locally and remotely, by way
of the skin.
II. Exemplary Neurostimulation Regimens
[0044] The neurostimulation systems described above with reference
to FIGS. 1-9 have application in a wide variety of stimulation
regimens. Examples of such regimens are illustrated in FIGS. 10-16.
FIGS. 10-13 graphically illustrate the changes in transmembrane
potential (.DELTA.Vm) of neural fibers in fiber bundles that are in
the vicinity of certain electrodes when electric fields are
generated by the electrodes during the neurostimulation regimens,
while FIGS. 14-16 highlight portions of tissue structures where the
change in transmembrane potential is above a predetermined level.
The neurostimulation regimens illustrated in FIGS. 10-13 are
associated with neurostimulation systems employing a lead that is
generally parallel to the neural fibers, while the neurostimulation
regimens illustrated in FIGS. 14-16 are associated with
neurostimulation systems employing a lead that is generally
transverse to the neural fibers. Additionally, although the present
inventions are not so limited, the regimens illustrated in FIGS.
10-13 are discussed in the context of first and second fiber
bundles FB1 and FB2. In the illustrated examples, the first fiber
bundle FB1 is the closest fiber bundle to the electrodes, the
second fiber bundle FB2 is the next closest fiber bundle to the
electrodes, and the first fiber bundle is located between the
second fiber bundle and the electrodes.
[0045] Conventional stimulation regimens for use with a lead that
is generally parallel to the neural fibers, which serve as a
reference for certain stimulation regimens in accordance with the
present inventions, are illustrated in FIGS. 10 and 11. In FIG. 10,
electrodes E1-E3 are activated in a conventional stimulation
regimen where electrodes E1 and E3 are functioning as anodes and
electrode E2 is functioning as a cathode. No current is sourced or
sunk at any of the other electrodes. E1ectrodes E1 and E3 are each
sourcing 50% of the total current (e.g., 1 mA each) and 100% of the
total current (e.g., 2 mA) is being sunk at electrode E2. As such,
there is local current balance at the stimulation site. The
depolarizing electric field generated by electrode E2 is sufficient
to create APs in some of the neural fibers in the first fiber
bundle FB1. In other words, the depolarization threshold DPT has
been met for the first fiber bundle FB1 in the tissue adjacent
electrode E2. The depolarizing electric field generated by
electrode E2 is substantially weaker at the second fiber bundle FB2
and is below the AP-creating depolarization threshold DPT. The
locus of stimulation is, therefore, defined by the portion of the
depolarizing electric field generated by electrode E2 that is at or
above the depolarization threshold DPT.
[0046] E1ectrodes E1 and E3, which are functioning as anodes in the
stimulation regimen illustrated in FIG. 10, will create
hyperpolarizing electric fields in the neural tissue adjacent to
electrodes E1 and E3. When the electric field is at or above the
hyperpolarization threshold HPT, the neural fibers within the
electric field will block APs that were fired at other points along
the fibers. It should be noted here that the magnitude of the
hyperpolarization threshold HPT has been estimated to be about 2 to
8 times the magnitude of the depolarization threshold DPT. The
hyperpolarizing electric fields generated by electrodes E1 and E3
in the exemplary stimulation regimen are below the
hyperpolarization threshold HPT at the first fiber bundle FB1. As
such, APs in the fiber bundle FB1 that fired at points in the
neural fibers adjacent to electrode E2 will not be blocked at
points adjacent to electrodes E1 and E3. The hyperpolarizing
electric fields generated by electrodes E1 and E3 will, of course,
be even weaker at the second fiber bundle FB2.
[0047] Turning to FIG. 11, electrodes E1 and E2 are activated in a
conventional stimulation regimen where electrode E1 is functioning
as an anode and electrode E2 is functioning as a cathode. No
current is sourced at any other electrode. All of the current
sourced at electrode E1 (e.g. 2 mA) is being sunk at electrode E2
and there is local current balance. With respect to the first fiber
bundle FB1, the depolarizing electric field generated by electrode
E2 meets the depolarization threshold DPT, which will result in the
generation of APs by at least some of the fibers in the first fiber
bundle. The hyperpolarizing electric field generated by electrode
E1 is below the hyperpolarization threshold HPT and, accordingly,
the APs will not be blocked. Within the fiber bundle FB2, the
depolarizing electric field generated by electrode E2 is below the
depolarization threshold DPT and the hyperpolarizing electric field
generated by electrode E1 is below the hyperpolarization threshold
HPT.
[0048] In both of the regimens described above, the generation of
APs in the fibers within the second fiber bundle FB2 will require
an increase in the depolarizing electric field generated by
electrode E2 over that illustrated in FIGS. 10 and 11. There may be
instances where the generation of APs in the first fiber bundle
FB1, which necessarily results from the creation of a depolarizing
electric field that is strong enough to meet the depolarization
threshold DPT at the second fiber bundle FB2, may lead to
undesirable outcomes (e.g. discomfort or undesirable reflexive
activity) for the patient. Some of the present inventions solve
this problem by preventing APs generated in the first fiber bundle
FB1 from reaching the brain or end organ. Specifically, such
inventions create local AP blocks and the AP blocks prevent APs
created within a portion of the depolarizing electric field that is
at or above the depolarization threshold DPT from traveling, in one
direction or both directions, beyond the stimulation site. The
effective locus of stimulation is, therefore, the region of neural
fibers that are generating APs that are not blocked at other
portions of the stimulation site.
[0049] As illustrated in FIG. 12, one example of a stimulation
regimen in accordance with a present invention involves locally
blocking APs generated in the first fiber bundle FB1. At least a
substantial portion of the APs (i.e., >10-20%) are blocked by
hyperpolarizing tissue in the first fiber bundle FB1, located on
opposite sides of the tissue in the first fiber bundle FB1 that is
generating the APs, to at least the hyperpolarization threshold
HPT. This may be accomplished by significantly increasing the level
of current sourced from electrodes E1 and E3, as compared to the
level illustrated in FIG. 10 (e.g., about 2.5 mA each), in order to
reach the hyperpolarization threshold HPT within the first fiber
bundle FB1 at electrodes E1 and E3. Turning to electrode E2, the
amount of current sunk at electrode E2 should be sufficient to
create a depolarizing electric field that is strong enough to meet
the depolarization threshold DPT at the second fiber bundle FB2 and
cause fibers within the second fiber bundle to generate APs.
[0050] The inventor herein has determined that sinking all of the
current sourced by electrodes E1 and E3 at electrode E2 could
result in a depolarizing electric field that would meet or exceed
the depolarization threshold DPT in fiber bundles well beyond the
second fiber bundle FB2. In those instances where the creation of
APs beyond the second fiber bundle FB2 is undesirable, a portion of
the current sourced by the electrodes E1 and E3 will be sunk at an
electrode that is located remotely from stimulation site, thereby
creating a local current imbalance at the stimulation site. Sinking
some of the current at a remote electrode allows the intensity of
the depolarizing electric field created by electrode E2 to be
reduced to a level where the hyperpolarization threshold HPT will
not be met in fibers within the second fiber bundle FB2.
[0051] The portion of the current in the exemplary stimulation
regimen illustrated in FIG. 12 that is sourced by electrodes E1 and
E3, but is not sunk at electrode E2, is sunk at the IPG case
electrode Ecase. Although the relative amounts may vary to suit
particular situations, a majority of the current is sunk at
electrode Ecase in the illustrated example. More specifically, 60%
of the current sourced by electrodes E1 and E3 is sunk at electrode
Ecase and the remaining 40% is sunk at electrode E2. There are a
variety of advantages associated with the use of the case electrode
Ecase as a remote cathode in a locally imbalanced stimulation
regimen. For example, because the case electrode Ecase will
typically be much larger than the lead electrodes, the current
density and electric field intensity will be greatly reduced. This
reduces the likelihood that the non-target tissue in the vicinity
of the case electrode Ecase will be stimulated. IPG cases are also
typically located in areas, such as a subcutaneous pocket in the
abdomen, where there is not a substantial amount of tissue that is
susceptible to stimulation.
[0052] It should be noted here that there are a variety ways to
remotely sink current. One example is, as discussed above, sinking
current at the remotely located case electrode Ecase. Current may
also be sunk, for example, at some or all of the electrodes on a
remotely implanted lead. Another example is sinking current at a
dedicated, and preferably spherical, remotely implanted electrode
on the end of a lead.
[0053] Another exemplary stimulation regimen in accordance with a
present invention, which may be employed when AP block is only
desired in a single direction, is illustrated in FIG. 13. Here,
electrode E1 is functioning as an anode and electrode E2 is
functioning as a cathode. No other local electrodes are sourcing or
sinking current. The amount of current sourced from electrode E1
(e.g. about 4-8 mA) is sufficient to reach the hyperpolarization
threshold HPT within the first fiber bundle FB1, thereby creating a
local AP block at electrode E1 in at least a substantial portion of
the fibers (i.e. >10-20%) within the first fiber bundle. The
amount of current being sunk at electrode E2 is sufficient to
create a depolarizing electric field that is strong enough to meet
the depolarization threshold DPT at the second fiber bundle FB2 and
cause fibers within the second fiber bundle to generate APs. Such a
depolarizing electric field will, of course, also cause the fibers
in the first fiber bundle FB1 to generate APs. However, at least a
substantial portion of the APs in the first fiber bundle FB1 will
be prevented from passing electrode E1 by the
hyperpolarization.
[0054] Additionally, in those instances where the creation of APs
in fibers beyond the second fiber bundle FB2 is undesirable, a
portion of the current sourced by electrode E1 will be sunk at an
electrode that is located remotely from the stimulation site,
thereby creating a local current imbalance at the stimulation site.
As noted above, this reduces the intensity of the depolarizing
electric field created by electrode E2 to a level where the
hyperpolarization threshold HPT will not be met beyond the second
fiber bundle FB2. In the illustrated regimen, the current from
electrode E1 that is not sunk at electrode E2 is sunk at the IPG
case electrode Ecase. Although the relative amounts may vary to
suit particular situations, a majority of the current is sunk at E2
in the illustrated example. More specifically, 60% of the current
sourced by electrode E1 is sunk at electrode E2 and the remaining
40% is sunk at electrode Ecase.
[0055] Turning to stimulation regimens for use with a lead that is
oriented generally transverse to the neural fibers, and as
illustrated for example in FIG. 14, such regimens frequently
include electrodes over the center of the dorsal column DC and over
the dorsal roots DR on either side of the dorsal column. A
conventional stimulation regimen, which will serve as a reference
for certain stimulation regimens in accordance with the present
inventions, is illustrated in FIG. 14. Here, electrodes E1 and E3
are functioning as anodes and electrode E2 is functioning as a
cathode. E1ectrodes E1 and E3 are each sourcing 50% of the total
current (e.g., 1 mA each) and 100% of the total current (e.g., 2
mA) is being sunk at electrode E2. No other electrodes are
activated and there is local current balance at the stimulation
site. The combination of the hyperpolarizing electric fields
generated by electrodes E1 and E3 and the depolarizing electric
field generated by electrode E2 results in an area within the
dorsal column DC that is at or above the depolarization threshold.
This area, which has an overall depth and width, is the locus of
stimulation LOS.
[0056] The present inventor has determined that locally current
balanced stimulation regimens, such as that illustrated in FIG. 14,
do not allow the depth and width of the locus of stimulation LOS to
be highly controllable using only total current sunk and sourced.
For example, conventional, locally-current-balanced stimulations
regimens would not allow the regimen programmer to reduce the width
of the regimen illustrated in FIG. 14 without effecting the depth.
Stimulation regimens in accordance with some of the present
inventions, on the other hand, employ a local current imbalance
that facilitates high fidelity control of the width and depth of
the locus of stimulation LOS.
[0057] As illustrated in FIG. 15, a stimulation regimen in
accordance with one example of a present invention employs a local
current imbalance and a remote cathode to provide the desired locus
of stimulation LOS. More specifically, as compared to the
stimulation regimen illustrated in FIG. 14, the stimulation regimen
illustrated in FIG. 15 creates a locus of stimulation LOS that has
a smaller width and the same depth. The current sourced at
electrodes E1 and E3 is increased (e.g., 4-8 mA each) in order to
strengthen the hyperpolarizing electric fields created thereby.
Strengthening of the hyperpolarizing electric fields created by
electrodes E1 and E3 tends to result in a narrowing the locus of
stimulation LOS because it weakens the lateral edges of the
depolarizing electric field created by electrode E2. Additionally,
the amount of current sunk at electrode E2 may be controlled such
that the depth of the locus of stimulation LOS is the same as that
illustrated in FIG. 14. More specifically, a portion of the total
current sourced at electrodes E1 and E3 (e.g., 40%) is sunk at
electrode E2, which is functioning as a local cathode to depolarize
tissue, and the remainder of the total current sourced at
electrodes E1 and E3 (e.g., 60%) is sunk at a remote electrode. In
the illustrated example, the remote electrode is the case electrode
Ecase. No current is sourced or sunk by other electrodes in this
example.
[0058] Current steering techniques may also be employed with local
current imbalances to further control the locus of stimulation LOS.
Referring for example to FIG. 16, the current sourced the
electrodes E1 and E3 in the illustrated stimulation regimen is not
equal. Electrode E1 is sourcing 80% of the total anodic current
(e.g., 8 mA) and electrode E3 is sourcing the other 20% of the
total anodic current (e.g., 2 mA). The locus of stimulation LOS is,
accordingly, "steered" toward to electrode E3. With respect to the
local current imbalance that is employed to control the depth of
the locus of stimulation LOS, a portion of the total current
sourced at electrodes E1 and E3 (e.g., 40%) is sunk at electrode E2
and the remainder of the total current sourced at electrodes E1 and
E3 (e.g., 60%) is sunk at a remote electrode. Here too, the remote
electrode is the case electrode Ecase. No current is sourced or
sunk by other electrodes in this example.
[0059] Stimulation regimens that involve the local current
imbalances of the type described above with reference to FIGS. 12,
13, 15 and 16 may be developed by the programmer during and/or
after the lead placement process. For example, and referring to
FIG. 17, the external programmer 124 (FIG. 1) may be used to cause
the IPG 110 to source and sink current in a locally balanced
stimulation regimen of the type described above with reference to
FIGS. 10, 11 and 14 after the lead(s) are in place (Step 200). In
those instances where the stimulation regimen is not providing the
desired paresthesia, the external programmer 124 may be used to
cause the IPG 110 to increase the anodic current (Step 210). The
additional anodic current may be used to block APs in certain fiber
bundles (FIGS. 12 and 13) or to alter the shape of the portion of
the electric field that is generating APs (FIGS. 15 and 16). If
necessary, the external programmer 124 may also be used to cause
the IPG 110 to create a locally imbalanced stimulation regimen,
where some of the anodic current is sunk at a remote location such
as the IPG case 122 (Step 220).
[0060] Although the inventions disclosed herein have been described
in terms of the preferred embodiments above, numerous modifications
and/or additions to the above-described preferred embodiments would
be readily apparent to one skilled in the art. By way of example,
but not limitation, the present inventions include neurostimulation
systems that also comprise at least one neurostimulation lead. It
is intended that the scope of the present inventions extend to all
such modifications and/or additions and that the scope of the
present inventions is limited solely by the claims set forth
below.
* * * * *