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Patent 2646907 Summary

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(12) Patent Application: (11) CA 2646907
(54) English Title: NON-LINEAR ELECTRODE ARRAY
(54) French Title: MATRICE D'ELECTRODES NON LINEAIRE
Status: Dead
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61N 1/05 (2006.01)
(72) Inventors :
  • ANDERSON, MEREDITH L. (United States of America)
  • PIANCA, ANNE M. (United States of America)
(73) Owners :
  • BOSTON SCIENTIFIC NEUROMODULATION CORPORATION (United States of America)
(71) Applicants :
  • BOSTON SCIENTIFIC NEUROMODULATION CORPORATION (United States of America)
(74) Agent: NA
(74) Associate agent: NA
(45) Issued:
(86) PCT Filing Date: 2007-01-10
(87) Open to Public Inspection: 2007-10-18
Examination requested: 2011-03-14
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US2007/060310
(87) International Publication Number: WO2007/117728
(85) National Entry: 2008-09-16

(30) Application Priority Data:
Application No. Country/Territory Date
11/396,309 United States of America 2006-03-31

Abstracts

English Abstract

A system for stimulation includes an implantable pulse generator, a lead, and conductors. The lead includes an array body disposed at a distal end of the lead and electrodes concentrically arranged on the array body. A center electrode may also be disposed on the array body. The electrodes may be arranged in more than one concentric ring. A method of using an implantable stimulator includes implanting an implantable stimulator and providing an electrical signal to at least one electrode of the implantable stimulator to stimulate a tissue. The electrical signal may be provided between diametrically opposed electrodes or between electrodes that are not diametrically opposed. If the implantable stimulator has a center electrode, the electrical signal may be provided between the center electrode and at least one concentrically arranged electrode.


French Abstract

L'invention concerne un système de stimulation qui inclut un générateur d'impulsions implantable, un câble, et des conducteurs. Le câble inclut une matrice disposée à l'extrémité distale du câble et des électrodes disposées de manière concentrique sur la matrice. On peut également installer une électrode centrale sur la matrice. Les électrodes peuvent être disposées de manière à former plus d'un anneau concentrique. Une méthode d'utilisation d'un stimulateur implantable consiste à implanter un stimulateur implantable et à appliquer un signal électrique à au moins une électrode du stimulateur implantable pour stimuler des tissus. Le signal électrique peut être appliqué entre des électrodes diamétralement opposées ou entre des électrodes qui ne sont pas diamétralement opposées. Si le stimulateur implantable possède une électrode centrale, le signal électrique peut être appliqué entre l'électrode centrale et au moins une des électrodes disposées de manière à former des anneaux concentriques.

Claims

Note: Claims are shown in the official language in which they were submitted.




CLAIMS


What is claimed as new and desired to be protected by Letters Patent of the
United
States is:


1. A lead comprising:

an array body disposed at a distal end of the lead; and

a plurality of electrodes concentrically arranged on the array body.

2. The lead of claim 1, wherein the plurality of electrodes are arranged
symmetrically
with respect to one or more central axes.

3. The lead of claim 1, wherein at least two electrodes are diametrically
opposed.
4. The lead of claim 1, wherein no two electrodes are diametrically opposed.

5. The lead of claim 1, further comprising a center electrode disposed on the
array
body and centrally located with respect to the plurality of electrodes.

6. The lead of claim 1, wherein at least one electrode is a non-circular
electrode.

7. The lead of claim 6, wherein the at least one electrode is a non-circular
electrode
having a major axis and a minor axis.






8. The lead of claim 7, wherein the plurality of electrodes are arranged in
more than
one concentric ring, and wherein the major axis of at least one electrode in a
first one of the
concentric rings is arranged radially and the major axis of at least one
electrode in a second one of
the concentric rings is arranged tangentially.

9. The lead of claim 1, wherein the plurality of electrodes are concentrically
arranged
in more than one concentric ring.

10. The lead of claim 9, wherein no electrode in a first concentric ring is
aligned
coaxially with an electrode in a second concentric ring.

11. The lead of claim 9, wherein at least one electrode in a first concentric
ring is
aligned coaxially with at least one electrode in a second concentric ring.

12. The lead of claim 1, wherein the array body is circular.
13. The lead of claim 1, wherein the array body is elliptical.
14. A system for stimulation comprising:

an implantable pulse generator;

a lead comprising an array body disposed at a distal end of the lead and a
plurality of electrodes concentrically arranged on the array body; and



16



a plurality of conductors, wherein a one of the conductors is attached to each

electrode, and wherein the conductors are configured and arranged to couple
the
electrodes to the implantable pulse generator.

15. A method of using an implantable stimulator, comprising:

implanting an implantable stimulator comprising a lead comprising an array
body disposed at a distal end of the lead and a plurality of electrodes
concentrically
arranged on the array body; and

providing an electrical signal to at least one electrode to stimulate a
tissue.
16. The method of claim 15, wherein providing an electrical signal comprises
bilaterally
stimulating the tissue.

17. The method of claim 15, wherein providing an electrical signal comprises
providing
an electrical signal between diametrically opposed electrodes.

18. The method of claim 15, wherein providing an electrical signal comprises
providing
an electrical signal between electrodes that are not diametrically opposed.

19. The method of claim 15, wherein the stimulator further comprises a center
electrode
disposed on the array body and centrally located with respect to the plurality
of electrodes.



17



20. The method of claim 19, wherein providing an electrical signal comprises
providing
an electrical signal between the centrally located electrode and at least one
of the concentrically
arranged electrodes.



18

Description

Note: Descriptions are shown in the official language in which they were submitted.



CA 02646907 2008-09-16
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NON-LINEAR ELECTRODE ARRAY

This application is a continuation-in-part of U.S. Patent Application Serial
No. 11/319,291, filed December 27, 2005, incorporated herein by reference.

FIELD
The invention is directed to implantable stimulators. In addition, the
invention is
directed to implantable stimulators having electrodes arranged concentrically,
and methods of using
the devices.

BACKGROUND OF THE INVENTION
Stimulators have been developed to provide therapy for a variety of disorders,
as well as
other treatments. For example, stimulators can be used in neurological therapy
by stimulating
nerves or muscles, for urinary urge incontinence by stimulating nerve fibers
proximal to the
pudendal nefves of the pelvic floor, for erectile and other sexual
dysfunctions by stimulating the
cavernous nerve(s), for reduction of pressure sores or venous stasis,-etc.

Stimulators, such as the BION" device (available from Advanced Bionics
Corporation,
Sylmar, CA), have exposed electrodes and a small, often cylindrical, housing
that contains the
electronic circuitry and power source that produce electrical pulses at the
electrodes for stimulation
of the neighboring tissue. Other stimulators, such as the Precision
rechargeable stimulator, in
combination with linear/percutaneous leads or paddle type leads are used to
stimulate the spinal
. .
cord for treating intractable chronic pain. It is preferable that the
electronic circuitry and power
source be held within the housing in a hermetically-sealed environment for the
protection of the user
and the protection of the circuitry and power source. Once implanted; it is
often preferable that the
stimulator can be controlled and/or that the electrical source can be charged
without removing the
stimulator from-the implanted environment.


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BRIEF SUMMARY OF THE INVENTION
In one embodiment, a lead includes an array body disposed at a distal end of
the lead
and electrodes concentrically arranged on the array body. The concentrically
arranged electrodes
may also be arranged symmetrically with respect to one or more central axes,
arranged such that at
least two electrodes are diametrically opposed, or arranged such that no two
electrodes are
diametrically opposed. A center electrode may also be disposed on the array
body. The electrodes
may be arranged in more than one concentric ring.

In another embodiment, a system for stimulation includes an implantable pulse
generator, a lead, and conductors. The lead of the system for stimulation
includes an array body
disposed at a distal end of the lead and electrodes concentrically arranged on
the array body. At
least one of the conductors is attached to each electrode, and the conductors
are configured and
arranged to couple the electrodes to the implantable pulse generator.

In yet another embodiment, a method.of using animplantabTe stimulator includes
implanting an implantable stimulator and providing an electrical signal to at
least one electrode of
the implantable stimulator. to stimulate a tissue. The implantable stimulator
includes a lead. The
lead includes an array body disposed at a distal end of the lead and
electrodes conceritrically
arranged on the array body. The electrical signal may be provided such that
the tissue is bilaterally
stimulated. The electrical signal-may also be provided between diametrically
opposed electrodes or
between electrodes that are not diametrically opposed: If the implantable
stimulator has a center
electrode, the. electrical signat may be provided between the center electrode
and at least.one.
concentrically arranged electrode.

BRIEF DESCRIPTION OF THE DRAWINGS
.
Non-limiting -and non-exhaustive embodiments of the present invention are
described
with reference to the following drawings. In the drawings, like reference
numerals refer to like
parts throughout the various figures unless otherwise specified.
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For a better understanding of the present invention, reference will be made to
the
following Detailed Description, which is to be read in association with the
accompanying drawings,
wherein:

FIG. 1 is a schematic exterior perspective view of one embodiment of a system
for
stimulation, according to the invention; and

FIG. 2 is a schematic perspective view of one embodiment of an array body,
according
to the invention; and

FIG. 3 is a schematic perspective view of a second embodiment of an array
body,
according to the invention; and

FIG. 4 is a schematic perspective view of a third embodiment of an array body,
according to the invention; and

FIG. 5 is a schematic perspective view of a fourth embodiment of an array
body,
according to the.invention; and

FIG. 6 is a schematic perspective view of a fifth embodiment of an array body,
according to the invention; and

FIG. 7 is a schematic perspective view of a sixth embodiment of an array body,
according to the invention;.and

FIG. 8 is a schematic perspective view of a seventh erribodiment of ari array
body,
according to the invention; and

FIG. 9 is a schematic.perspective view, of an eighth embodiment of an array
body,
according to the invention; and

FIG. 10 is a schematic overview of components of a system for stimulation,
according
to an embodiment of the invention.

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DETAILED DESCRIPTION OF THE INVENTION
The invention is directed to implantable stimulators. In addition, the
invention is
directed to implantable stimulators having electrodes arranged concentrically,
and methods of using
the devices.

Examples of stimulators and stimulator systems are found in U.S. Patents Nos.
6,609,032; 6,181,969; 6,516,227; 6,609,029; and 6,741,892; and U.S. Patent
Application Serial Nos.
11/238,240; 11/319,291; and 11/327,880, all of which are incorporated herein
by reference.

In at least some applications, it is desirable that the electrodes of an
implantable
stimulator be arranged in a non-linear arrangement. For example, a non-linear
arrangement of
electrodes may be desirable when the tissue to be stimulated is not oriented
in a straight line. A
non-linear arrangement of electrodes may also facilitate effective positioning
of an implantable
stimulator relative to the tissue to be stimulated. For example; a non-linear
electrode array that is
circular may provide sirnilar stimulation when positioned anywhere from 0 to
360 degzees: TYiiS
may facilitate faster implantation by allowing.greater latitude in.placement
of the lead and the
electrodes.

Alternatively, or additionally, an implantable stimulator vvith a non-linear
arrangement
of electrodes may be desirable when it is advantageous to alter the electrode
coverage area. For
example, the electrode coverage area of concentrically arranged electrodes may
provide a different
20. electrode coverage area than a linear arrangement of the same electrodes,
which may be. desirable. ,.
depending, for example, on the tissue to be stimulated. Non-linear electrode
arrangements may
also be particularly suited for stimulating certain tissues, such as when
bilateral stimulation is
desirable.

In at least some embodiments, a lead includes an array body disposed at a
distal end .of
the lead and electrodes concentrically arranged on the array body. In some
embodiments; the
electrodes are arranged in more than one concentric ring. The array body may
optionally include a
centrally located electrode.

4


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Figure 1 illustrates schematically one embodiment of a stimulation system 100.
The
stimulation system includes an implantable pulse generator 102, an array body
104, and at least one
lead body 106 coupling the implantable pulse generator 102 to the array body
104. The array body
104 and the lead body 106 form a lead. It will be understood that the system
for stimulation can
include more, fewer, or different components and can have a variety of
different configurations
including those configurations disclosed in the stimulator references cited
herein. The stimulation
system or components of the stimulation system, including one or more of the
lead body 106, the
array body 104 and the implantable pulse generator 102, are implanted into the
body.

The implantable pulse generator 102 typically includes a housing 114 with an
electronic subassembly 110 and, in at least some embodiments, a power source
120 disposed within
a chamber in the housing. Preferably, the housing is resistant to moisture
penetration into the
chamber containing the electronic subassembly and power source. In some
embodiments, water
may diffuse through the housing. Preferably, the diffused water is relatively
pure, without
substantial 'ionic content, as deionized water is relatively non-conductive.

The housing 114 may, be made of any biocompatible material includirig, for
example,
glass, ceramics,'metals, and "polymers. In one embodiment, the housing 114 is
made- from
implantable grade titanium. In another embodiment, the housing 114 of the
implantable pulse
generator is formed of a plastic material that resists the transport of
moisture into the interior of the
housing and is sufficiently sturdy to protect.the components on the interior
of the housing from.
damage under expected usage conditions. Preferably, thematerial of the plastic-
housing is a
hydrophobic polymer material. The housing 114 may.include additives such as,
for example, fillers,
plasticizers, antioxidants,. colorants, and the like. The thickness of the
walls of the housing may also
impact the moisture permeability of the housing. A minimum thickness needed to
achieve a
particular degree of resistance to moisture transport will often depend on the
material selected for
the housing, as well as any additives.

Optionally, the housing 114 can be covered, in fitll or in part, with a
coating. The
coating can be provided to improve or alter one or more properties of the
housing 114 including, for
example, biocompatibility, hydrophobicity, moisture permeability, leaching of
material into or out

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of the housing, and the like. In one embodiment, a coating can be applied
which contains a
compound, such as, for example, a drug, prodrug, hormone, or other bioactive
molecule, that can be
released over time when the stimulator is implanted. (In another embodiment,
the housing itself
may include such a compound to be released over time after implantation.)

In one embodiment, a conductor or conductors (not shown) couple the
electrode(s) 154 to
the implantable pulse generator 102. The conductors can be formed using any
conductive material.
Examples of suitable materials include, for example, metals, alloys,
conductive polymers, and
conductive carbon. In one embodiment, the conductors are insulated by an
insulating material,
except for the portion of the conductor attached to the electrode 154,
implantable pulse generator
102, or other components of the electronic circuitry. The insulating material
may be any material
that is a poor conductor of an electrical signal, including, for example,
TeflonTM, non-conductive
polymers, or metal oxidation that is poor in electrical conductivity.

The array body 104 may be made of any biocompatible material including, for
example, silicone, polyurethane, polyetheretherketone (PEEK), epoxy, and the
like. The ar.ray
body 104 may be formed by any process including, for example, molding
(including injection
molding), casting and the like. In'one embodiment, a method of making an array
body is diselosed.
in U.S. Patent Application Serial No. 11/319,291, which is incorporated herein
by reference. The
array body 104 can have any shape including, for example, a circular,
elliptical, square or
rectangular shape. Preferably the array body is solid.

Electrodes 154 are disposed on the array body.' The electrodes 154 can be
inade using
any conductive ma.terrial. Examples of suitable materials include, for
example, metals, alloys,
conductive polymers, and conductive carbon. The number of electrodes 154
disposed on the array -
body 104 may vary, depending on the application for which
the.electrodes.l54,wi1l be used (e.g.,
brain stimulation, neural stimulation, spinal cord stimulation, etc.). For
example, there can be two,
three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen,
fourteen, fifteen, sixteen, or
more electrodes 154. As will be recogr-ized, other numbers of electrodes 154
may also be used.
The electrodes 154 may have any shape including for example, a circular,
elliptical,
square, or rectangular shape. Circular electrodes 154 have a constant radius.
In some
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embodiments, the electrodes 154 are non-circular. Non-circular electrodes
often have a width that
is not equal to the length of the electrode 154. In some embodiments, non-
circular electrodes have
a major axis 130 that bisects the larger dimension of the electrode and a
minor axis 140 that bisects
the smaller dimension of the electrode. The major axis 130 and the minor axis
140 of one example
of a non-circular electrode are illustrated schematically in Figure 2. As will
be recognized, other
non-circular electrodes are also possible. Alternatively, the electrodes 154
may be designed to have
a shape that allows the electrode arrangement to follow the external boundary
of the array body 104.

The electrodes 154 are arranged concentrically on the array body 104. The
arrangement
of the electrode(s) 154 on the array body 104 may vary. Electrodes 154
arranged concentrically on
an array body 104 are arranged around a common center and can form circles or
ellipses. In some
embodiments, electrodes 154 arranged concentrically on an array body 104 are
illustrated
schematically in, for example, Figures 2, 3, 4, 5, 6, 7, 8, and 9. As will be
recognized, other
concentric arrangements of electrodes 154 are also possible.

Electrodes 154 may also be. arranged on the array body. 104 such that there is
a centrally
located electrode 154' as illustrated in Figures 3, 5 and 9. A centrally
located electrode 154' is
located at the common center of the concentrically arranged electrodes 154.
For example, centra=lly
located electrodes 15.4j and 154`k are, illustrated schematically in Figures 3
and 5, respectively.

Electrodes 154 may be arranged on the array body 104 symmetrically with
respect -to
one or more central axes 150 as illustrated, for example, in Figures 4, 5 and
6. A central axis 150
bisects the arrangement of electrodes 154. When electrodes 154 are arranged on
the array body
104 symmetrically with respect to a central axis 150, the electrodes 154 on
one side of the central
axis' 150 are arranged in a mirror image of the elect7rodes 154 arranged on
the opposite side of the
central axis 150. As will be recognized, other. symmetrical arrangements of
electrodes 154 are also
possible. An array body 104 with electrodes 154 arranged symmetrically with
respect to one or
more central, axes 150.can have any shape.

Electrodes 154 may be arranged on the array body 104 such that at least two
electrodes.
154 are diametrically opposed. For example, electrode 154e and electrode 154f
illustrated
schematically in Figure 4 are diametrically opposed. As will be recognized,
other arrangements of
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electrodes 154 on an array body 104 in which at least two electrodes 154 are
diametrically opposed
are also possible. In other embodiments, no two electrodes 154 are
diametrically opposed.

As will be recognized, electrodes 154 arranged with at least two electrodes
154
diametrically opposed may also be concentrically arranged. Electrodes 154
arranged with at least
two electrodes 154 diametrically opposed may also be arranged symmetrically
with respect to one
or more central axes 150 as illustrated, for example, in Figure 4. Likewise,
electrodes 154 can be
arranged symmetrically with respect to one or more central axes 150 such that
no two electrodes
154 are diametrically opposed such as in Figures 2 and 3. An array body 104
with at least two
electrodes 154 diametrically opposed or with no two electrodes 154
diametrically opposed can have
any shape including, for example, a circular shape or an elliptical shape.

Electrodes 154 may be concentrically arranged on the array body 104 in more
than one
concentric ring as illustrated, for example, in Figures 5-9. The concentric
rings have a common
center and each concentric ring may be in the shape of a circle or an ellipse.
For exarnple,
electrodes 154 may be arranged concentrically in two or more circles that
share a common center
but have different radii; as illustrated in Figures 5, 6, and 7.
Alternatively, electrodes 154 may be
arranged concentrically in two or more ellipses as illustrated in Figures 8
and 9. In, some
embodiments, electrodes 154 may be concentrically arranged in more than one
concentric ring,.
where the concentric rings have different shapes. For example, electrodes 154
may be arranged
concentrically in an ellipse and a circle that share a common center:

An array body 104 may include electrodes 154 concentrically arranged on the
array
body 104 in rimore than one concentric ring in addition to having a centrally
located electrode 154',
electrodes 154 arranged symmetrically with respect to one or more central
axes, and/or
diametrically opposed electrodes 154.

Electrodes 154 may be non-circular electrodes. Non-circular electrodes are
illustrated,
for example, in Figures 2, 3, 4, 5, 6, and 9. For example, electrodes 154a,
154b,-and '154c in Figure
2, and electrode 154f in Figure 4 are electrodes 154 that are non-circular.
In.some embodiments,
non-circular electrodes have a minor axis 140 and a major axis130. Non-
circular electrodes may be

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arranged concentrically in more than one concentric ring as illustrated, for
example, in Figures 5
and 6.

In some embodiments, the major axis 130 of at least one non-circular electrode
in a first
concentric ring is arranged radially and the major axis 130 of at least one
non-circular electrode in a
second concentric ring is arranged tangentially. For example, Figure 5
illustrates a non-circular
electrode 154g in a first concentric ring with its major axis 130 (see e.g.
Figure 2) arranged radially
and a non-circular electrode 154h in a second concentric ring with its major
axis 130 arranged
tangentially.

Alternatively, the major axis 130 of at least one non-circular electrode in a
first
concentric ring may be arranged tangentially and the major axis 130 of at
least one non-circular
electrode in a second concentric ring may be arranged radially. For example,
in Figure 6, the major
axis 130 of a non-circular electrode 154m in a first concentric ring is
arranged tangentially and the
major axis 130 of a non-circular electrode 154n in a second concentric ring is
arranged radially.
Non-circular electrodes can also be arranged in-any configuration between
tangential and radial
.15 orientations.

As will be recognized, an array body 104 may contain non-c'ircula'r"electrodes
haVing a.
minor axis 140 and a major axis 130 in addition to having concentrically
arranged electrodes 154, a
centrallylocated electrode 154', electrodes 154 arranged symmetrically with
respect to one or more
central axes 150, electrodes 154 arranged in more than one concentric ring,
and/or diametrically
opposed electrodes 154. Likewise, an array body 104 with non-circular
electrodes arranged
concentrically in more than one concentric ring in which the major axis130 of
a non-circular
electrode is arranged radially in a first concentric ring arid a major axis
130 of another non-circular
electrode in a second concentric ring is arranged tangentially may also have a
centrally located
electrode 154', eleetrodes 154 arranged symmetrically with respect to one or
more central axes 150,
and/or diametrically opposed electrodes 154. An array body having at least one
non-circular
electrode arranged radially and at least one non-circular electrode arranged
tangentially can have
any shape.

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In some embodiments, at least one electrode 154 in a first concentric ring is
aligned
coaxially with at least one electrode 154 in a second concentric ring as
illustrated, for example, in
Figures 5 and 6. For example, in Figure 5, electrode 154g in a first
concentric ring is aligned
coaxially with electrode 154h in a second concentric ring. In Figure 5,
electrode 154g in a first
concentric ring is also aligned coaxially with electrode 1541 in a second
concentric ring. As will be
recognized, other arrangements of electrodes in which an electrode in a first
concentric ring is
aligned coaxially with an electrode in a second concentric ring are possible.
In other embodiments,
no electrode in a concentric ring is aligned coaxially with an electrode in an
adjacent concentric
ring.

An array body 104 having concentrically arranged electrodes 154 with at least
one
electrode 154 in a first concentric ring aligned coaxially with at least one
electrode in a second
concentric ring may also have diametrically opposed electrodes 154, electrodes
154 arranged
symmetrically with respect to one or more central axes 150, and/or a centrally
located electrode
154'. An array body 104 having at least one electrode 154 in.a first-
eoncentric= ring aligned : a.
coaxially with at least one electrode in a second concentric ring may have
any, shape.

Figure 10 is a'schematic overview of one embodiment of components of a system
for
stimulation, including an electronic subassembly.110 (which.may or may not
include the power .
source -1-20), according to the invention. It will be understood that the
system for stimulation and
the electronic subassembly 110 can include more, fewer, or different
components and can have a
. variety of different configurations including those configurations disclosed
in the stimulator
references cited herein. Some or all of the components of the system for
stimulation can be
positioned on one or more circuit boards or similar carriers within a housing
of a stimulator, if
desired.

Any power source 120 can be used including, for example, a battery such as a.
primary
battery or a rechargeable. battery. Examples of other power sources include
super capacitors,
nuclear or atomic batteries, mechanical resonators, infrared collectors,
thermally-powered energy
sources, flexural powered energy sources,'bioenergy power sources, fuel cells,
bioelectric cells,



CA 02646907 2008-09-16
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osmotic pressure pumps, and the like including the power sources described in
U.S. Patent
Application Publication No. 2004/0059392, incorporated herein by reference.

As another alternative, power can be supplied by an external power source
through
inductive coupling via the optional antenna 124 or a secondary antenna. The
extemal power source
can be in a device that is mounted on the skin of the user or in a unit that
is provided near the
stimulator user on a permanent or periodic basis.

If the power source 120 is a rechargeable battery, the battery may be
recharged using the
optional antenna 124, if desired. Power can be provided to the battery 120 for
recharging by
inductively coupling the battery tbrough the antenna to a recharging unit 210
(see Figure 10)
external to the user.

In one embodiment, electrical current is emitted by the electrodes 154 to
stimulate
motor nerve fibers, muscle fibers, or other body tissues near the stimulator.
The electronic
subassembly 110 provides the electronics used to operate the stimulator and
generate the electrical
pulses at the electrodes 154 to produce stimulation of the body tissues.
Figure 10 illustrates one
embodiment of components of the electronic subassembly and associated units.

In the illustrated embodiment, a processor 204 is generally included in the
electronic
. ,.. .. ..
subassembly 110 to'control the timing and electrical characteristics of the
stimulator:. For example,
the processor can, if desired, control one or more of the timing, frequency,
strength; duration, and
waveform of the pulses. In addition, the processor 204 can select:which
electrodes can be used to
provide stimulation, if desired. In some embodiments, the processor may select
which electrode(s)
are cathodes and whicli e7ectrode(s) are anodes. In some embodirnents with
electrodes disposed on.
two or more sides of the housing, the processor may be used to identify which
electrodes provide
the most useful stimulation of the desired tissue. This process
may.be.perform.ed using an extexnal
programming unit, as described below, that is in communication with the
processor 204.

Any processor can be used and can be as simple as an electronic device that
produces
pulses at a regular interval or the processor can be capable of receiving and
interpreting instructions
from an external programming unit 208 that allow modification of pulse
characteristics. In the

11


CA 02646907 2008-09-16
WO 2007/117728 PCT/US2007/060310
illustrated embodiment, the processor 204 is coupled to a receiver 202 which,
in turn, is coupled to
the optional antenna 124. This allows the processor to receive instructions
from an external source
to direct the pulse characteristics and the selection of electrodes, if
desired.

In one embodiment, the antenna 124 is capable of receiving signals (e.g., RF
signals)
from an external telemetry unit 206 which is programmed by a programming unit
208. The
programming unit 208 can be external to, or part of, the telemetry unit 206.
The telemetry unit 206
can be a device that is worn on the skin of the user or can be carried by the
user and can have a form
similar to a pager or cellular phone, if desired. As another alternative, the
telemetry unit may not be
worn or carried by the user but may only be available at a home station or at
a clinician's office.
The programming unit 208 can be any unit that can provide information to the
telemetry unit for
transmission to the stimulator. The programming unit 208 can be part of the
telemetry unit 206 or
can provide signals or information to the telemetry unit via a wireless or
wired connection. One
example of a suitable programming,unit is a computer operated by the user or
clinician to send
signals to the telemetry unit.

The signals sent to the processor 204 via the antenna 124 and.receiver 202 can
be used
to modify or otherwise direct the operation of the stimulator. For example,
the signals may be.used
to modify the pulses of the stimulator such as modifying one or more of pulse
duration, pulse
frequency, pulse waveform, and pulse strength. The signals may also direct the
stimulator to cease
operation or to start operation or to start charging the battery. In other
embodiments, the electronic
..20 subassembly 11=0 does not include an antenna 124 or receiver, 202 and the
processor operates as
programmed..

Optionally, the stimulator may include a transmitter (not shown) coupled to
the
processor and antenna for transmitting signals back to the telemetry unit 206
or another unit capable
of receiving the signals. For example, the stimulator may transmit signals
indicating whether the
stimulator is operating properly or not or indicating when the battery needs
to be charged. The
processor may also be capable of transmitting information about the pulse
characteristics so that a
user or clinician can determine or verify-the characteristics. .

12


CA 02646907 2008-09-16
WO 2007/117728 PCT/US2007/060310
The optional antenna 124 can have any form. In one embodiment, the antenna
comprises a coiled wire that is wrapped at least partially around the
electronic subassembly within
or on the housing.

Any method of manufacture of the components of the system for stimulation can
be
used. For example, the power source and antenna can be manufactured as
described in U.S. Patent
Application Publication No. 2004/0059392. These components can then be placed
inside the
housing (or, alternatively, the housing can be formed, e.g., molded, around
the components).

A stimulator can be implanted into a patient and electrical signals can be
provided to the
conductive electrode(s) 154 to stimulate a tissue. In one embodiment, a method
of using an
implantable stimulator includes implanting an implantable stimulator
comprising a lead. The lead
comprises an array body 104 disposed at a distal end of the lead. Electrodes
154 are concentrically
arranged on the array body 104. An electrical signal is provided to at least
one electrode 154
arranged on the array body 104 to stimulate a tissue:

An implantable stimulator can be implanted into the body tissue using a
variety of
methods including surgical methods. In some embodiments, the stim.ulator
can.be implanted using
a hypodermic needle or other insertion cannula. Examples of insertion
techniques can be found in
U.S. Patent No. 6,051,017.

An electrical signal may be provided to the electrodes 154 of an implantable
stim-alator
having electrodes 154 concentrically arranged on ain array body 104 such that
a tissue is bilaterally
stimulated. In other embodiments, two leads having array bodies 104 with
concentrically arranged
electrodes 154 may be used to bilaterally stimulate a tissue.

The stimulator el=ectrodes 154 may be selectively stimulated. Electrical
signals may be
provided to the electrodes 154 of the=stimulator simultaneously.
'Alternatively, electrical signals can
be provided to the electrodes 1.54 of the stimulator independently of one
another. Coordination of
the electrical signals provided to the electrode(s) 154 is often facilitated
by a processor 204.

13


CA 02646907 2008-09-16
WO 2007/117728 PCT/US2007/060310

An electrical signal may be provided to the electrodes 154 of an implantable
stimulator
such that the electrical signal is provided between electrodes 154 that are
diametrically opposed.
For example, an electrical signal can be provided between diametrically
opposed electrodes 154e
and 154f in Figure 4. As will be recognized, an electrical signal could be
provided to electrodes 154
in other arrangements in which at least two electrodes 154 are diametrically
opposed.

An electrical signal may also be provided to the electrodes 154 of an
implantable
stimulator such that the electrical signal is provided between electrodes 154
that are not
diametrically opposed. For example, an electrical signal could be provided
between electrode 154d
and electrode 154a in Figure 2. As will be recognized, an electrical signal
could be provided
between electrodes 154 in other arrangements in which the electrodes receiving
an electrical signal
are not diametrically opposed.

Alternatively, an electrical signal may be provided to the electrodes 154 of
an
implantable stimulator such that the electrical signal is provided between a
centrally located
electrode 154' and a concentrically arranged electrode 154. For example, an.
electrical signal could
be provided between the concentrically arranged electrode 154i and'the
centrally located electrode
154'j 'in Figure 3. As will be recognized, an electrical'signal could be
provided between electrodes
154 in other arrangements in which the electrodes receiving an electrical
signal include a centrally
located electrode 154' and a concentrically arranged electrode 154.

The
e above specification, examples and data provide a description of the
manufacture
. .. .. , . :
and use of the composition of the irivention. Since many embodiments of the
invention can be
made without departing from the spirit'and. scope of the invention, the
invention also resides in the
claims hereinafter appended.

14

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date Unavailable
(86) PCT Filing Date 2007-01-10
(87) PCT Publication Date 2007-10-18
(85) National Entry 2008-09-16
Examination Requested 2011-03-14
Dead Application 2015-05-29

Abandonment History

Abandonment Date Reason Reinstatement Date
2014-05-29 R30(2) - Failure to Respond
2015-01-12 FAILURE TO PAY APPLICATION MAINTENANCE FEE

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Application Fee $400.00 2008-09-16
Maintenance Fee - Application - New Act 2 2009-01-12 $100.00 2008-09-16
Maintenance Fee - Application - New Act 3 2010-01-11 $100.00 2010-01-04
Maintenance Fee - Application - New Act 4 2011-01-10 $100.00 2010-12-17
Request for Examination $800.00 2011-03-14
Maintenance Fee - Application - New Act 5 2012-01-10 $200.00 2011-12-19
Maintenance Fee - Application - New Act 6 2013-01-10 $200.00 2012-12-27
Maintenance Fee - Application - New Act 7 2014-01-10 $200.00 2013-12-23
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Past Owners on Record
ANDERSON, MEREDITH L.
PIANCA, ANNE M.
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
Documents

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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Abstract 2008-09-16 2 68
Claims 2008-09-16 4 91
Drawings 2008-09-16 4 73
Description 2008-09-16 14 768
Representative Drawing 2008-09-16 1 6
Cover Page 2009-01-29 2 42
Description 2013-05-09 14 743
Claims 2013-05-09 3 109
PCT 2008-09-16 3 150
Assignment 2008-09-16 4 148
Correspondence 2008-12-16 5 164
PCT 2008-09-22 1 45
Fees 2010-01-04 1 56
Fees 2010-12-17 1 202
Prosecution-Amendment 2011-03-14 2 62
Fees 2011-12-19 1 163
Prosecution-Amendment 2012-11-15 3 116
Prosecution-Amendment 2012-01-11 5 169
Fees 2012-12-27 1 163
Prosecution-Amendment 2012-03-02 3 87
Prosecution-Amendment 2012-04-26 3 99
Prosecution-Amendment 2013-05-09 26 1,128
Prosecution-Amendment 2013-06-12 3 95
Prosecution-Amendment 2013-11-29 3 119
Fees 2013-12-23 1 33
Office Letter 2016-01-08 1 34
Office Letter 2016-01-08 1 36