U.S. patent application number 12/712107 was filed with the patent office on 2010-06-17 for non-linear electrode array.
This patent application is currently assigned to Boston Scientific Neuromodulation Corporation. Invention is credited to Meredith L. Anderson, Anne M. Pianca.
Application Number | 20100152818 12/712107 |
Document ID | / |
Family ID | 38581706 |
Filed Date | 2010-06-17 |
United States Patent
Application |
20100152818 |
Kind Code |
A1 |
Anderson; Meredith L. ; et
al. |
June 17, 2010 |
NON-LINEAR ELECTRODE ARRAY
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.
Inventors: |
Anderson; Meredith L.;
(Billerica, MA) ; Pianca; Anne M.; (Valencia,
CA) |
Correspondence
Address: |
Boston Scientific Neuromodulation Corp.;c/o Frommer Lawrence & Haug LLP
745 Fifth Ave
NEW YORK
NY
10151
US
|
Assignee: |
Boston Scientific Neuromodulation
Corporation
Valencia
CA
|
Family ID: |
38581706 |
Appl. No.: |
12/712107 |
Filed: |
February 24, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11396309 |
Mar 31, 2006 |
7672734 |
|
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12712107 |
|
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|
11319291 |
Dec 27, 2005 |
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11396309 |
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Current U.S.
Class: |
607/72 ; 607/116;
607/148 |
Current CPC
Class: |
A61N 1/0551 20130101;
A61N 1/05 20130101; A61N 1/0553 20130101; A61N 1/0529 20130101 |
Class at
Publication: |
607/72 ; 607/148;
607/116 |
International
Class: |
A61N 1/05 20060101
A61N001/05; A61N 1/04 20060101 A61N001/04; A61N 1/36 20060101
A61N001/36 |
Claims
1.-20. (canceled)
21. A lead comprising: an array body disposed at a distal end of
the lead, wherein the array body has a substantially flat, front
surface; and a plurality of electrodes concentrically arranged on
the substantially flat, front surface of the array body, wherein at
least one electrode of the plurality of electrodes is a
non-circular electrode having a major axis and a minor axis, and
wherein the at least one non-circular electrode defines two linear,
parallel side boundaries of that electrode and two opposing
half-circle curved end boundaries of that electrode, each curved
end boundary connected to the two side boundaries.
22. The lead of claim 21, wherein the plurality of electrodes are
arranged symmetrically with respect to one or more central
axes.
23. The lead of claim 21, wherein at least two electrodes of the
plurality of electrodes are diametrically opposed.
24. The lead of claim 21, wherein no two electrodes of the
plurality of electrodes are diametrically opposed.
25. The lead of claim 21, further comprising a center electrode
disposed on the array body and centrally located with respect to
the plurality of electrodes.
26. The lead of claim 21, wherein the plurality of electrodes are
concentrically arranged in a plurality of concentric rings.
27. The lead of claim 26, wherein at least one electrode of the
plurality of electrodes in a first concentric ring of the plurality
of concentric rings is aligned coaxially with at least one
electrode of the plurality of electrodes in a second concentric
ring of the plurality of concentric rings.
28. The lead of claim 26, wherein a major axis of at least one
non-circular electrode of the plurality of electrodes in a first
concentric ring of the plurality of concentric rings is arranged
radially and a major axis of at least one non-circular electrode of
the plurality of electrodes in a second concentric ring of the
plurality of concentric rings is arranged tangentially.
29. The lead of claim 26, wherein a major axis of at least one
non-circular electrode of the plurality of electrodes in a first
concentric ring of the plurality of concentric rings and a major
axis of at least one non-circular electrode of the plurality of
electrodes in a second concentric ring of the plurality of
concentric rings are arranged radially.
30. A system for stimulation comprising: an implantable pulse
generator; and the lead of claim 21.
31. A lead comprising: an array body disposed at a distal end of
the lead, wherein the array body has a substantially flat, front
surface; and a plurality of electrodes concentrically arranged in
at least one concentric ring on the substantially flat, front
surface of the array body, wherein no two electrodes of the
plurality of electrodes in a first concentric ring of the at least
one concentric ring are diametrically opposed.
32. The lead of claim 31, wherein no two electrodes of the
plurality of electrodes in any concentric ring of the at least one
concentric ring are diametrically opposed.
33. A lead comprising: an array body disposed at a distal end of
the lead, wherein the array body has a substantially flat, front
surface; and a plurality of electrodes concentrically arranged in
at least one concentric ring on the substantially flat, front
surface of the array body, the plurality of electrodes comprising a
first electrode and a second electrode that are each non-circular
electrodes having a major axis and a minor axis, wherein each of
the first electrode and the second electrode defines two linear,
parallel side boundaries of that electrode and two opposing
half-circle curved end boundaries of that electrode, each curved
end boundary connected to the two side boundaries, and wherein the
first electrode and the second electrode are aligned coaxially.
34. The lead of claim 33, wherein the major axis of the first
electrode is aligned coaxially with the major axis of the second
electrode.
35. The lead of claim 33, wherein the major axis of the first
electrode is aligned coaxially with the minor axis of the second
electrode.
36. The lead of claim 33, wherein the first electrode is in a first
concentric ring and the second electrode is in a second concentric
ring, and wherein the major axis of the first electrode is aligned
coaxially with the major axis of the second electrode.
37. The lead of claim 33, wherein the first electrode is in a first
concentric ring of the at least one concentric ring and the second
electrode is in a second concentric ring of the at least one
concentric ring, and wherein the major axis of the first electrode
is aligned coaxially with the minor axis of the second
electrode.
38. The lead of claim 33, wherein the plurality of electrodes are
arranged symmetrically with respect to one or more central
axes.
39. The lead of claim 33, further comprising a center electrode
disposed on the array body and centrally located with respect to
the plurality of electrodes
40. A system for stimulation comprising: an implantable pulse
generator; and the lead of claim 33.
Description
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 11/319,291, filed Dec. 27, 2005, incorporated
herein by reference.
FIELD
[0002] 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
[0003] 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 nerves 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.
[0004] Stimulators, such as the BION.RTM. device (available from
Advanced Bionics Corporation, Sylmar, Calif.), 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.RTM. 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.
BRIEF SUMMARY OF THE INVENTION
[0005] 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.
[0006] 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.
[0007] In yet another embodiment, 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 implantable
stimulator includes a lead. The lead includes an array body
disposed at a distal end of the lead and electrodes concentrically
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 signal may be provided between the center electrode and
at least one concentrically arranged electrode.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] 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.
[0009] 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:
[0010] FIG. 1 is a schematic exterior perspective view of one
embodiment of a system for stimulation, according to the invention;
and
[0011] FIG. 2 is a schematic perspective view of one embodiment of
an array body, according to the invention; and
[0012] FIG. 3 is a schematic perspective view of a second
embodiment of an array body, according to the invention; and
[0013] FIG. 4 is a schematic perspective view of a third embodiment
of an array body, according to the invention; and
[0014] FIG. 5 is a schematic perspective view of a fourth
embodiment of an array body, according to the invention; and
[0015] FIG. 6 is a schematic perspective view of a fifth embodiment
of an array body, according to the invention; and
[0016] FIG. 7 is a schematic perspective view of a sixth embodiment
of an array body, according to the invention; and
[0017] FIG. 8 is a schematic perspective view of a seventh
embodiment of an array body, according to the invention; and
[0018] FIG. 9 is a schematic perspective view of an eighth
embodiment of an array body, according to the invention; and
[0019] FIG. 10 is a schematic overview of components of a system
for stimulation, according to an embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0020] 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.
[0021] Examples of stimulators and stimulator systems are found in
U.S. Pat. Nos. 6,609,032; 6,181,969; 6,516,227; 6,609,029; and
6,741,892; and U.S. patent application Ser. Nos. 11/238,240;
11/319,291; and 11/327,880, all of which are incorporated herein by
reference.
[0022] 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 similar stimulation
when positioned anywhere from 0 to 360 degrees. This may facilitate
faster implantation by allowing greater latitude in placement of
the lead and the electrodes.
[0023] Alternatively, or additionally, an implantable stimulator
with 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 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.
[0024] 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.
[0025] FIG. 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.
[0026] 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.
[0027] The housing 114 may be made of any biocompatible material
including, 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, the material 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.
[0028] Optionally, the housing 114 can be covered, in full 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 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.)
[0029] 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.
[0030] The array body 104 may be made of any biocompatible material
including, for example, silicone, polyurethane,
polyetheretherketone (PEEK), epoxy, and the like. The array 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 disclosed in U.S.
patent application Ser. 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.
[0031] Electrodes 154 are disposed on the array body. The
electrodes 154 can be made using any conductive material. 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 154 will 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 recognized,
other numbers of electrodes 154 may also be used.
[0032] 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 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 FIG. 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.
[0033] 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, FIGS. 2, 3, 4, 5, 6, 7, 8, and 9. As will be
recognized, other concentric arrangements of electrodes 154 are
also possible.
[0034] Electrodes 154 may also be arranged on the array body 104
such that there is a centrally located electrode 154' as
illustrated in FIGS. 3, 5 and 9. A centrally located electrode 154'
is located at the common center of the concentrically arranged
electrodes 154. For example, centrally located electrodes 154'j and
154'k are illustrated schematically in FIGS. 3 and 5,
respectively.
[0035] 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 FIGS. 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 electrodes 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.
[0036] 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 FIG. 4 are diametrically opposed. As will be
recognized, other arrangements of 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.
[0037] 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 FIG. 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
FIGS. 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.
[0038] Electrodes 154 may be concentrically arranged on the array
body 104 in more than one concentric ring as illustrated, for
example, in FIGS. 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 example, electrodes 154 may be arranged concentrically
in two or more circles that share a common center but have
different radii, as illustrated in FIGS. 5, 6, and 7.
Alternatively, electrodes 154 may be arranged concentrically in two
or more ellipses as illustrated in FIGS. 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.
[0039] An array body 104 may include electrodes 154 concentrically
arranged on the array body 104 in more 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.
[0040] Electrodes 154 may be non-circular electrodes. Non-circular
electrodes are illustrated, for example, in FIGS. 2, 3, 4, 5, 6,
and 9. For example, electrodes 154a, 154b, and 154c in FIG. 2, and
electrode 154f in FIG. 4 are electrodes 154 that are non-circular.
In some embodiments, non-circular electrodes have a minor axis 140
and a major axis 130. Non-circular electrodes may be arranged
concentrically in more than one concentric ring as illustrated, for
example, in FIGS. 5 and 6.
[0041] 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, FIG. 5 illustrates a non-circular electrode 154g in a
first concentric ring with its major axis 130 (see e.g. FIG. 2)
arranged radially and a non-circular electrode 154h in a second
concentric ring with its major axis 130 arranged tangentially.
[0042] 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 FIG. 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
orientations.
[0043] As will be recognized, an array body 104 may contain
non-circular electrodes having a minor axis 140 and a major axis
130 in addition to having concentrically arranged electrodes 154, a
centrally located 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 axis 130 of a non-circular
electrode is arranged radially in a first concentric ring and 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', electrodes 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.
[0044] 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
FIGS. 5 and 6. For example, in FIG. 5, electrode 154g in a first
concentric ring is aligned coaxially with electrode 154h in a
second concentric ring. In FIG. 5, electrode 154g in a first
concentric ring is also aligned coaxially with electrode 154l 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.
[0045] 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
concentric ring aligned coaxially with at least one electrode in a
second concentric ring may have any shape.
[0046] FIG. 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
120), 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.
[0047] 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, osmotic
pressure pumps, and the like including the power sources described
in U.S. Patent Application Publication No. 2004/0059392,
incorporated herein by reference.
[0048] 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 external 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.
[0049] 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 through the antenna to a
recharging unit 210 (see FIG. 10) external to the user.
[0050] 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. FIG. 10 illustrates one embodiment
of components of the electronic subassembly and associated
units.
[0051] 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 which
electrode(s) are anodes. In some embodiments 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 performed
using an external programming unit, as described below, that is in
communication with the processor 204.
[0052] 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 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.
[0053] 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.
[0054] 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 subassembly 110 does not
include an antenna 124 or receiver 202 and the processor operates
as programmed.
[0055] 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.
[0056] 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.
[0057] 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).
[0058] 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.
[0059] An implantable stimulator can be implanted into the body
tissue using a variety of methods including surgical methods. In
some embodiments, the stimulator can be implanted using a
hypodermic needle or other insertion cannula. Examples of insertion
techniques can be found in U.S. Pat. No. 6,051,017.
[0060] An electrical signal may be provided to the electrodes 154
of an implantable stimulator having electrodes 154 concentrically
arranged on an 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.
[0061] The stimulator electrodes 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 154 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.
[0062] 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 FIG. 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.
[0063] 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 FIG. 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.
[0064] 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 FIG. 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.
[0065] The above specification, examples and data provide a
description of the manufacture and use of the composition of the
invention. 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.
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