U.S. patent application number 12/237888 was filed with the patent office on 2010-03-25 for leads with non-circular-shaped distal ends for brain stimulation systems and methods of making and using.
This patent application is currently assigned to Boston Scientific Neuromodulation Corporation. Invention is credited to Andrew DiGiore, Ellis Garai, Courtney Lane, James C. Makous, Anne M. Pianca.
Application Number | 20100076535 12/237888 |
Document ID | / |
Family ID | 41395565 |
Filed Date | 2010-03-25 |
United States Patent
Application |
20100076535 |
Kind Code |
A1 |
Pianca; Anne M. ; et
al. |
March 25, 2010 |
LEADS WITH NON-CIRCULAR-SHAPED DISTAL ENDS FOR BRAIN STIMULATION
SYSTEMS AND METHODS OF MAKING AND USING
Abstract
A lead is configured and arranged for brain stimulation. The
lead includes a proximal end and a distal end. The proximal end
includes a plurality of terminals disposed at the proximal end. The
distal end has a non-circular transverse cross-sectional shape and
includes a plurality of electrodes disposed at the distal end. A
plurality of conductive wires electrically couple at least one of
the plurality of electrodes to at least one of the plurality of
terminals.
Inventors: |
Pianca; Anne M.; (Santa
Monica, CA) ; Lane; Courtney; (Ventura, CA) ;
Makous; James C.; (Santa Clarita, CA) ; DiGiore;
Andrew; (Santa Monica, CA) ; Garai; Ellis;
(Sherman Oaks, CA) |
Correspondence
Address: |
Boston Scientific Neuromodulation Corp.;c/o DARBY & DARBY P.C.
P.O. BOX 770, Church Street Station
NEW YORK
NY
10008-0770
US
|
Assignee: |
Boston Scientific Neuromodulation
Corporation
Valencia
CA
|
Family ID: |
41395565 |
Appl. No.: |
12/237888 |
Filed: |
September 25, 2008 |
Current U.S.
Class: |
607/116 |
Current CPC
Class: |
A61N 1/0529 20130101;
A61N 1/0472 20130101; A61N 1/36082 20130101; A61N 1/0534
20130101 |
Class at
Publication: |
607/116 |
International
Class: |
A61N 1/05 20060101
A61N001/05 |
Claims
1. A lead configured and arranged for brain stimulation, the lead
comprising: a proximal end comprising a plurality of terminals
disposed at the proximal end; a distal end having a non-circular
transverse cross-sectional shape, the distal end comprising a
plurality of electrodes disposed at the distal end; and a plurality
of conductive wires, each of the plurality of conductive wires
electrically coupling at least one of the plurality of electrodes
to at least one of the plurality of terminals.
2. The lead of claim 1, wherein the distal end has a non-circular
transverse cross-sectional shape that comprises at least three
faces.
3. The lead of claim 2, wherein at least one of the plurality of
electrodes is disposed on at least two faces.
4. The lead of claim 1, wherein the distal end has a non-circular
transverse cross-sectional shape that comprises at least two arms
extending away from a center of the lead.
5. The lead of claim 4, wherein at least two of the arms form an
acute angle.
6. The lead of claim 5, wherein at least one of the plurality of
electrodes is disposed on each of the arms so that at least one
electrode disposed on each of two of the arms face towards each
other across the acute angle.
7. The lead of claim 4, wherein the at least two of the arms form
an obtuse angle.
8. The lead of claim 7, wherein at least one of the plurality of
electrodes is disposed on each of the arms so that at least one
electrode disposed on each of two of the arms face towards each
other across the obtuse angle.
9. The lead of claim 4, wherein at least two of the arms form an
acute angle and at least two of the arms form an obtuse angle.
10. The lead of claim 1, wherein the distal end of the lead has a
transverse cross-sectional geometric shape that is one of a
triangle, a rectangle, a pentagon, a hexagon, a heptagon, or an
octagon.
11. The lead of claim 1, wherein the distal end of the lead has an
irregular transverse cross-sectional geometric shape.
12. The lead of claim 1, wherein the distal end of the lead has a
transverse cross-sectional shape that is one of a cruciform, a
Y-shape, an L-shape, an acutely-angled V-shape, an obtusely-angled
V-shape, a U-shape, a C-shape, an I-shape, a five-sided star, a
six-sided star, or a seven-sided star.
13. The lead of claim 1, wherein the proximal end of the lead has a
circular transverse cross-sectional shape.
14. A lead configured and arranged for brain stimulation, the lead
comprising: a proximal end comprising a plurality of terminals
disposed at the proximal end; a distal end comprising a plurality
of electrodes disposed at the distal end, wherein the distal end
defines a hollow interior region that is open at the distal end,
the hollow interior region having a longitudinal length, an outer
surface external to the hollow interior region, and an inner
surface lining the sides of the hollow interior region; and a
plurality of conductive wires, each of the plurality of conductive
wires electrically coupling at least one of the plurality of
electrodes to at least one of the plurality of terminals.
15. The lead of claim 14, wherein the distal end has a circular
transverse cross-sectional shape.
16. The lead of claim 14, wherein the distal end further comprises
at least one slit defined along at least a portion of the
longitudinal length of the hollow interior region.
17. The lead of claim 14, wherein at least a portion of the
plurality of electrodes are disposed on the inner surface of the
hollow interior region.
18. The lead of claim 14, wherein the plurality of electrodes are
disposed on the outer surface of the hollow interior region.
19. The lead of claim 14, wherein at least one of the plurality of
electrodes is disposed on the inner surface of the hollow interior
region and at least one of the plurality of electrodes is disposed
on the outer surface of the hollow interior region.
20. A method for stimulating patient brain tissue, the method
comprising: implanting a lead into a brain of a patient, the lead
comprising a plurality of electrodes disposed on a distal end, the
distal end having a non-circular transverse cross-sectional shape,
the plurality of electrodes electrically coupled to a plurality of
terminals disposed on a proximal end, a plurality of conductive
wires electrically coupling at least one terminal to at least one
electrode; disposing the proximal end of the lead into a connector,
the connector configured and arranged for receiving the proximal
end of the lead, the connector comprising a plurality of connective
contacts that electrically couple to at least one of the plurality
of terminals, the connector electrically coupled to a control
module; and providing electrical signals from the control module to
electrically stimulate patient tissue using at least one of the
plurality of electrodes disposed on the distal end of the lead.
Description
TECHNICAL FIELD
[0001] The present invention is directed to the area of brain
stimulation systems and methods of making and using the systems.
The present invention is also directed to brain stimulation systems
that include leads with distal ends that have non-circular
transverse cross-sectional shapes configured and arranged to limit
stimulation to one or more discrete stimulation regions, as well as
methods of making and using the leads and brain stimulation
systems.
BACKGROUND
[0002] Deep brain stimulation can be useful for treating a variety
of conditions including, for example, Parkinson's disease,
dystonia, essential tremor, chronic pain, Huntington's Disease,
levodopa-induced dyskinesias and rigidity, bradykinesia, epilepsy
and seizures, eating disorders, and mood disorders. Typically, a
lead with a stimulating electrode at or near a tip of the lead
provides the stimulation to target neurons in the brain. Magnetic
resonance imaging ("MRI") or computerized tomography ("CT") scans
can provide a starting point for determining where the stimulating
electrode should be positioned to provide the desired stimulus to
target structures, such as neurons. To further refine the position,
a recording lead with a recording electrode at or near the tip of
the recording lead can be inserted into the brain of the patient to
determine a more precise location. Typically, the recording lead is
guided to the target location within the brain using a stereotactic
frame and microdrive motor system.
[0003] As the recording lead is moved through the brain, the
recording electrode is observed to determine when the recording
electrode is near the target structures. This observation may
include activating the target structures to generate electrical
signals that can be received by the recording electrode. Once the
position of the target structures is determined, the recording lead
can be removed and the stimulating lead inserted. The object of
this removal of the recording lead and insertion of the stimulating
lead is to attempt to precisely locate the target structures. The
precise insertion of the stimulating lead and positioning of the
stimulating lead in the precise location indicated by the recording
lead can be particularly difficult. In some instances, multiple
insertions of the recording lead and stimulating lead may need to
occur to properly position the stimulating electrode.
BRIEF SUMMARY
[0004] In one embodiment, a lead is configured and arranged for
brain stimulation. The lead includes a proximal end and a distal
end. The proximal end includes a plurality of terminals disposed at
the proximal end. The distal end has a non-circular transverse
cross-sectional shape and includes a plurality of electrodes
disposed at the distal end. A plurality of conductive wires
electrically couple at least one of the plurality of electrodes to
at least one of the plurality of terminals.
[0005] In another embodiment, a lead is configured and arranged for
brain stimulation. The lead includes a proximal end and a distal
end. The proximal end includes a plurality of terminals disposed at
the proximal end. The distal end includes a plurality of electrodes
disposed at the distal end. The distal end also defines a hollow
interior region that is open at the distal end. The hollow interior
region has a longitudinal length, an outer surface external to the
hollow interior region, and an inner surface lining the sides of
the hollow interior region. A plurality of conductive wires
electrically couple at least one of the plurality of electrodes to
at least one of the plurality of terminals.
[0006] In yet another embodiment, a method for stimulating patient
brain tissue includes implanting a lead into a brain of a patient.
The lead includes a plurality of electrodes disposed on a distal
end. The distal end has a non-circular transverse cross-sectional
shape. The plurality of electrodes are electrically coupled to a
plurality of terminals disposed on a proximal end. A plurality of
conductive wires electrically couple at least one terminal to at
least one electrode. The proximal end of the lead is disposed into
a connector. The connector is configured and arranged for receiving
the proximal end of the lead. The connector includes a plurality of
connective contacts that electrically couple to at least one of the
plurality of terminals. The connector is electrically coupled to a
control module. Electrical signals are provided from the control
module to electrically stimulate patient tissue using at least one
of the plurality of electrodes disposed on the distal end of the
lead.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] 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.
[0008] 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:
[0009] FIG. 1 is a schematic side view of one embodiment of a lead
and stylet, according to the invention;
[0010] FIG. 2A is a schematic cross-sectional view of one
embodiment of a lead with a plus-shaped lumen, according to the
invention;
[0011] FIG. 2B is a schematic cross-sectional view of one
embodiment of a stylet for use with the lead shown in FIG. 2A,
according to the invention;
[0012] FIG. 3A is a schematic cross-sectional view of one
embodiment of a distal end of a conventional lead with a circular
transverse cross-sectional shape, the lead having a ring-shaped
electrode emitting signals, shown as arrows projecting outward from
the electrode, some of which are stimulating a target structure,
shown with a crisscross hatching, as well as several non-target
structures, according to the invention;
[0013] FIG. 3B is a schematic cross-sectional view of one
embodiment of a distal end of a conventional lead with a circular
transverse cross-sectional shape, the lead having a
discretely-shaped electrode disposed on one side of the lead that
is emitting signals, shown as arrows projecting outward from the
electrode, and stimulating a target structure, shown with a
crisscross hatching, as well as a non-target structure, according
to the invention;
[0014] FIG. 4 is a schematic end view of a plurality of different
embodiments of distal ends of leads, each distal end having a
different transverse cross-sectional shape from the other distal
ends, according to the invention;
[0015] FIG. 5A is a schematic perspective view of one embodiment of
a lead with electrodes disposed on a plus-shaped distal end and
terminals disposed on a circular-shaped proximal end; according to
the invention;
[0016] FIG. 5B is a schematic transverse cross-sectional view of
one embodiment of a distal end of the lead shown in FIG. 5A with
two attached arms, the lead including a central lumen defined at
the intersection of the two arms and peripheral lumens defined
along each arm distal to the central lumen, according to the
invention;
[0017] FIG. 5C is a schematic transverse cross-sectional view of
one embodiment of a distal end of the lead shown in FIG. 5A with an
insertion rod of a stylet disposed in a central lumen and a
connector wire disposed in each of the peripheral lumens, according
to the invention;
[0018] FIG. 5D is a schematic transverse cross-sectional view of a
proximal end of the lead shown in FIG. 5A, the lead defining a
central lumen and also defining peripheral lumens disposed lateral
to the central lumen, according to the invention;
[0019] FIG. 6A is a schematic transverse cross-sectional view of
one embodiment of a distal end of the lead shown in FIG. 5A
positioned in an area divided into regions, the lead having
electrodes emitting signals that are stimulating target structures
positioned in two stimulation regions and not stimulating
non-target structures positioned in other regions, according to the
invention;
[0020] FIG. 6B is a schematic transverse cross-sectional view of
another embodiment of a distal end of the lead shown in FIG. 5A
positioned in an area divided into regions, the lead having
electrodes emitting signals that are stimulating target structures
positioned in two stimulation regions and not stimulating
non-target structures positioned in other regions, according to the
invention;
[0021] FIG. 7A is a schematic transverse cross-sectional view of
one embodiment of a distal end of one of leads shown in FIG. 4
positioned in an area divided into regions, the lead having
electrodes emitting signals that are stimulating target structures
positioned in one stimulation region and not stimulating non-target
structures positioned in the other region, according to the
invention;
[0022] FIG. 7B is a schematic transverse cross-sectional view of
another embodiment of a distal end of one of leads shown in FIG. 4
positioned in an area divided into regions, the lead having
electrodes emitting signals that are stimulating target structures
positioned in one stimulation region and not stimulating non-target
structures positioned in the other region, according to the
invention;
[0023] FIG. 8 is a schematic perspective view of one embodiment of
a distal end of one embodiment of a distal end of one of the leads
shown in FIG. 4, the lead having electrodes disposed on a
triangular-shaped distal end so that some of the electrodes are
disposed on multiple faces of the lead and some of the electrodes
disposed on a single face of the lead, according to the
invention;
[0024] FIG. 9 is a schematic perspective view of one embodiment of
a distal end of one embodiment of a distal end of one of the leads
shown in FIG. 4, the lead having electrodes disposed on a
rectangular-shaped distal end so that some of the electrodes are
disposed on multiple faces of the lead and some of the electrodes
disposed on a single face of the lead, according to the
invention;
[0025] FIG. 10A is a schematic perspective view of one embodiment
of one of leads shown in FIG. 4 having a with a circular transverse
cross-sectional shaped distal end with electrodes disposed in
linear patterns on an inner surface, according to the
invention;
[0026] FIG. 10B is a schematic perspective view of one embodiment
of the lead shown in FIG. 10A having a circular transverse
cross-sectional shaped distal end with electrodes disposed in a
linear pattern on both an inner surface and an outer surface,
according to the invention;
[0027] FIG. 10C is a schematic perspective view of one embodiment
of the lead shown in FIG. 10A having a circular transverse
cross-sectional shaped distal end with electrodes disposed in a
zigzag pattern on both an inner surface and an outer surface,
according to the invention;
[0028] FIG. 10D is a schematic perspective view of one embodiment
of the lead shown in FIG. 10A having a circular transverse
cross-sectional shaped distal end with electrodes disposed in a
linear pattern on an inner surface and electrodes disposed in a
zigzag pattern on an outer surface, according to the invention;
[0029] FIG. 11A is a schematic perspective view of one embodiment
of one of leads shown in FIG. 4 having a C-shaped distal end with
electrodes disposed in linear patterns on an inner surface,
according to the invention;
[0030] FIG. 11B is a schematic perspective view of one embodiment
of the lead shown in FIG. 11A having a C-shaped distal end with
electrodes disposed in a linear pattern on both an inner surface
and an outer surface, according to the invention;
[0031] FIG. 11C is a schematic perspective view of one embodiment
of the lead shown in FIG. 11A having a C-shaped distal end with
electrodes disposed in a first staggered pattern on an inner
surface and electrodes disposed in a second staggered patter on an
outer surface, according to the invention; and
[0032] FIG. 12 is a schematic overview of one embodiment of
components of a stimulation system, including an electronic
subassembly disposed within a control module, according to the
invention.
DETAILED DESCRIPTION
[0033] The present invention is directed to the area of brain
stimulation systems and methods of making and using the systems.
The present invention is also directed to brain stimulation systems
that include leads with distal ends that have non-circular
transverse cross-sectional shapes configured and arranged to limit
stimulation to one or more stimulation regions, as well as methods
of making and using the leads and brain stimulation systems.
[0034] A lead for deep brain stimulation can include both recording
and stimulation electrodes. This allows a practitioner to determine
the position of the target structures, such as neurons, using the
recording electrode(s) and then position the stimulation
electrode(s) accordingly without removal of a recording lead and
insertion of a stimulation lead. A lead can also include recording
electrodes spaced around the circumference of the lead to more
precisely determine the position of the target structures. In at
least some embodiments, the lead is rotatable so that the
stimulation electrodes can be aligned with target structures after
the neurons have been located using the recording electrodes.
[0035] FIG. 1 illustrates one embodiment of a device 100 for brain
stimulation. The device includes a lead 102, one or more
stimulation electrodes 104, one or more recording electrodes 106, a
connector 108 for connection of the electrodes to a control module,
and a stylet 110 for assisting in insertion and positioning of the
lead in the patient's brain.
[0036] The lead 102 can be formed of a non-conducting material such
as, for example, a polymeric material. Suitable polymeric materials
include, for example, silicone rubber and polyethylene. Preferably,
the lead is made using a biocompatible material. In at least some
instances, the lead may be in contact with body tissue for extended
periods of time.
[0037] The lead often has a cross-sectional diameter of no more
than 1.5 mm and may be in the range of 0.7 to 1.3 mm. The lead
often has a length of at least 10 cm and the length of the lead may
be in the range of 30 to 70 cm.
[0038] The lead typically defines a lumen 120 (see FIG. 2A) within
the lead for the removable stylet 110. Use of a stylet can
facilitate insertion of the lead into the cranium and brain tissue
and facilitate positioning the lead to stimulate the target
neurons. The stylet can provide rigidity to the lead during the
insertion process.
[0039] The lumen can have any shape. In at least some embodiments,
the lumen has a round transverse cross-sectional shape. In at least
some other embodiments, the transverse cross-sectional shape of the
lumen is non-circular. For example, the transverse cross-sectional
shape of the lumen can have an oval, square, rectangular, or, as
illustrated in FIG. 2A, a cruciform shape. The stylet 110 may have
a corresponding transverse cross-sectional shape. In at least some
embodiments, a stylet 110 has a round transverse cross-sectional
shape for use with a lead with a corresponding round transverse
cross-sectional shape. In at least some embodiments, the stylet 110
may have an oval, square, rectangular, or, as illustrated in FIG.
2B, a cruciform transverse cross-sectional shape for use with the
lead illustrated in FIG. 2A. Employing a non-circular transverse
cross-sectional shape can permit the practitioner to rotate the
lead 102 by rotating the stylet 110. Because the lumen is
non-circular, the stylet can not rotate within the lead and,
therefore, rotation of the stylet results in rotation of the lead.
A cruciform-shaped lumen can be particularly useful, as opposed to
an oval, square, or rectangular lumen, if the shape of the lumen
might be deformed by rotation of the stylet because the lead is not
sufficiently rigid. Shapes similar to a cruciform, with multiple
arms extending from a central cavity, such as an asterisk- or
star-shaped lumen and a corresponding stylet, can be similarly
useful.
[0040] The stylet 110 can be made of a rigid material. Examples of
suitable materials include tungsten, stainless steel, or plastic.
The stylet 110 may have a handle 111 to assist insertion into the
lead, as well as rotation of the stylet and lead.
[0041] Conductors 122 (e.g., wires) that attach to or form the
recording electrode(s) 106 and stimulation electrode(s) 104 also
pass through the lead 102. These conductors may pass through the
material of the lead as illustrated, for example, in one
configuration for FIG. 2A, or through the lumen 120 or through a
second lumen defined by the lead. The conductors 122 are presented
at the connector 108 for coupling of the electrodes 104, 106 to a
control module (not shown). The control module observes and records
signals from the recording electrodes 106. The same or a different
control module can also be used to provide stimulation signals,
often in the form of pulses, to the stimulation electrodes 104.
[0042] The lead 102 includes one or more recording electrodes 106
disposed along the longitudinal axis of the lead near a distal end
of the lead. In at least some embodiments, the lead includes a
plurality of recording electrodes. The recording electrodes can be
made using a metal, alloy, conductive oxide, or other conductive
material. Examples of suitable materials include platinum, iridium,
platinum iridium alloy, stainless steel, titanium, and
tungsten.
[0043] Any type of recording electrode can be used, including
monopolar recording electrodes, bipolar recording electrodes (as
illustrated in FIG. 1), and other multipolar recording electrodes.
In at least some embodiments, bipolar or other multipolar recording
electrodes are preferred because they can assist in finding nearby
electrical signals, and disregard distant electrical signals, by
observation of the differential between the signals from the two or
more, closely-spaced electrodes.
[0044] Any type of recording electrode can be used including
electrode pads or plates. A preferred recording electrode for at
least some embodiments is a tip of a wire. This type of electrode
can assist in more precise location of the target neurons because
of the small surface area and high impedance for detection of
electrical signals. Such recording electrodes often have a diameter
of no more than 100 .mu.m and no less than 25 .mu.m. The diameter
may be in the range from, for example, 25 .mu.m to 100 .mu.m. In
one embodiment, the recording electrodes 106 correspond to wire
conductors 122 that extend out of the lead 102 and are then trimmed
or ground down flush with the lead surface.
[0045] The lead 102 also includes one or more stimulation
electrodes 104 arranged along the longitudinal axis of the lead
near a distal end of the lead. In at least some embodiments, the
lead includes a plurality of stimulation electrodes. A conductor
122 is attached to each stimulation electrode 104. The stimulation
electrodes often have a surface area of at least 1 mm.sup.2 and no
greater than 6 mm.sup.2. The surface area may be in the range from,
for example, 1 mm.sup.2 to 6 mm.sup.2. A variety of shapes can be
used for the stimulation electrodes including, for example, rings,
circles, ovals, squares, rectangles, triangles, and the like. In
some embodiments, a stimulation electrode 104 forms a ring, or
other closed-loop shape, that fully or substantially encircles the
lead 102. Preferably, however, the stimulation electrodes are not
rings, but are instead discrete shapes disposed on one side of the
lead. Ring electrodes typically stimulate target structures on all
sides of the lead instead of focusing on the target structures that
may face only a portion of the lead circumference.
[0046] The stimulation electrodes can be made using a metal, alloy,
conductive oxide or other conductive material. Examples of suitable
materials include platinum, iridium, iridium oxide, platinum
iridium alloy, stainless steel, titanium, tungsten, or
poly(3,4-ethylenedioxythiophene (PEDOT). Preferably, the
stimulation electrodes are made of a material that is biocompatible
and does not substantially corrode under expected operating
conditions in the operating environment for the expected duration
of use.
[0047] The arrangement of recording electrodes 106 and stimulation
electrodes 104 on the lead 102 can facilitate detection and
stimulation of target structures, such as neurons. Some embodiments
include a single recording electrode and a single stimulation
electrode. Other embodiments, however, include two or more
recording electrodes, two or more stimulation electrodes, or
both.
[0048] Sometimes conventional brain stimulation systems employ
leads with a circular transverse cross-sectional shape. Leads with
a circular transverse cross-sectional shape may include one or more
rings of stimulation electrodes ("electrodes") disposed on distal
ends of the leads that emit signals, such as pulses of electric
current, in all directions around the distal ends of the leads.
Target structures within a certain distance from the one or more
rings of signal-emitting electrodes can be stimulated by the
signals. However, some non-target structures may also be positioned
so as to also be stimulated.
[0049] FIG. 3A shows a schematic end view of one embodiment of a
conventional lead 302 for a brain stimulation system. The lead 302
has a circular transverse cross-sectional shape and includes one or
more cylindrical electrodes 304 emitting signals, shown as arrows
such as arrow 306, projecting outward from the one or more
cylindrical electrodes 304. The signals are of approximately equal
strength in all directions normal to the lead 302. In FIG. 3A, a
target structure 308, shown in FIG. 3A and in subsequent figures as
a circle with a crisscrossed hatching, is shown being stimulated by
the lead 302. However, other non-target structures 310-312, are
also being stimulated by the lead 302. In at least some instances,
stimulating non-target structures may be undesirable and may cause
one or more negative effects on a patient, such as producing
patient pain, vision problems, speech problems, or cognitive
problems. As discussed above, with reference to FIG. 1, some
conventional leads utilize electrodes with discrete shapes disposed
along one side of the lead, such as the lead 314 shown in FIG. 3B.
However, electrodes disposed along one side of a lead with a
circular transverse cross-sectional shape, such as the electrode
316 disposed on the lead 314, may not offer much variance in the
directionality of signal emission.
[0050] In at least some embodiments, a lead compatible with a brain
stimulation system includes electrodes selectively disposed on a
non-circular transverse cross-sectional shaped distal end of the
lead so that the electrodes can emit signals within one or more
stimulation regions of different sizes and shapes. For example,
target structures can be stimulated in stimulation regions and
non-target structures in other regions can avoid being stimulated.
In at least some embodiments, the transverse cross-sectional shape
of the distal end of the lead may affect one or more variables of
signals emitted from the electrodes, such as the direction of the
signal emission, or the amplitude, or strength, of the signal
emission.
[0051] In at least some embodiments, de-activation of one or more
electrodes disposed on the lead may also affect one or more
variables of signals emitted from the electrodes, such as the
direction of the signal emission, or the strength of the signal
emission. In at least some embodiments, providing electrodes of
various sizes and shapes may further affect one or more variables
of signals emitted from the electrodes, such as the direction of
the signal emission, or the strength of the signal emission. In at
least some embodiments, when multiple regions are stimulated, each
stimulation region may utilize different stimulation parameters
from other stimulation regions. In at least some embodiments, when
there are multiple stimulation regions, each of the multiple
stimulation regions may be stimulated individually, simultaneously,
or sequentially.
[0052] In at least some embodiments, a distal end of a lead may
include a non-circular transverse cross-sectional shape configured
and arranged to limit signals emitted from one or more electrodes
disposed on the distal ends of the leads to selected stimulation
regions. FIG. 4 is a schematic end view of a plurality of different
embodiments of the transverse cross-sectional shape of distal ends
of leads 402-423 on which electrodes may be disposed. The distal
ends of the leads 402-423 each include a transverse cross-sectional
shape that is different from the other remaining leads 402-423.
Many different transverse cross-sectional shapes may be selected
that are either regular or irregular shapes, with straight edges or
curved edges. A few exemplary transverse cross-section shapes of
distal ends of suitable leads are shown in FIG. 4, including a
rectangle 402, a pentagon 403, a hexagon 404, a heptagon 405, an
octagon 406, a triangle 407, a cruciform-shape 408, a five-pointed
star 409, a six-pointed star 410, a seven-pointed star 411, a
cylinder-shape 412, a C-shape 413, a Y-shape 414, an L-shape 415
with arms of approximately equal length, an acutely-angled V-shape
416, an obtusely-angled V-shape 417, an irregular pentagon 418, an
I-shape 419, an alternate seven-pointed star with elongated arms
420, an alternate triangle with elongated arms 421, an L-shape 422
with arms of unequal length, and a U-shape 423.
[0053] In at least some embodiments, the sizes and the
distributions of the target structures may affect the selection of
shape of the lead to use for stimulation. In at least some
embodiments, the lead selected may have a transverse
cross-sectional shape that limits the one or more stimulation
regions of the lead to the smallest possible regions that
collectively stimulate the one or more desired target structures.
In at least some embodiments, some of the leads include transverse
cross-sectional shapes that have at least two attached arms that
can form different angles with each other, such as shapes 414-417,
and 419-422. Moreover, in at least some embodiments, the arms may
be of variable lengths, for example, shape 411 compared to shape
420, and shape 415 compared to shape 422. It will be understood
that other transverse cross-sectional shapes shown in FIG. 4 with
multiple arms may be altered by increasing or decreasing one or
more of the angles between two of the arms. Additionally, it will
be understood that other transverse cross-sectional shapes shown in
FIG. 4 with multiple arms may be altered by increasing or
decreasing the length one or more of the arms. Moreover, it will be
understood that the shapes may be smoothed to facilitate
manufacturing or safety in patient tissue.
[0054] In at least some embodiments, a lead with a non-circular
transverse cross-sectional shaped distal end, such as the leads
402-423, may have a circular transverse cross-sectional shaped
proximal end. In at least some embodiments, a lead with a circular
transverse cross-sectional shaped proximal end may facilitate
electrical connection of the lead with a control module.
Additionally, in at least some embodiments, when a lead includes a
non-circular transverse cross-sectional shaped distal end and a
circular transverse cross-sectional shaped proximal end, both ends
of the lead are configured and arranged for implantation using
conventional insertion needles and guide cannulas used for
electrical stimulation systems, such as brain stimulation
systems.
[0055] FIG. 5A is a schematic perspective view of a lead 408. The
lead 408 includes a distal end 502 that has a cruciform-shaped
transverse cross-sectional shape and a proximal end 504 that has a
circular transverse cross-sectional shape. The distal end 502 of
the lead 408 includes arms 506-509. Each arm 506-509 includes
electrodes, such as electrode 510, disposed on the distal end 502
of the lead 408. The proximal end 504 of the lead 408 includes
terminals 512.
[0056] In at least some embodiments, the electrodes disposed on the
lead 408 may be disposed on one or more sides of one or more of the
arms 506-509. In at least some embodiments, one or more of the arms
may include electrodes disposed in one or more rows or columns. In
at least some embodiments, the electrodes may be disposed in rows
or columns in either a regular or irregular pattern. In at least
some embodiments, the electrodes may be disposed in rows or columns
in a regular pattern, such as a level or staggered pattern.
[0057] FIG. 5B is a schematic transverse cross-sectional view of
one embodiment of the distal end 502 of the lead 408. The arm 506
defines peripheral lumens 514 and 515. The arm 507 defines
peripheral lumens 516 and 517. The arm 508 defines peripheral
lumens 518 and 519. The arm 509 defines peripheral lumens 520 and
521. The lead 408 also defines a central lumen 522 at the
intersection of the arms 506-509. In at least some embodiments,
there is one peripheral lumen defined in each arm 506-509. In at
least some embodiments, there are more than two lumens defined in
each arm 506-509. In at least some embodiments, the central lumen
522 and the peripheral lumens 514-521 are replaced by a single
lumen. FIG. 5C is a schematic transverse cross-sectional view of
one embodiment of the distal end 502 of the lead 408 with an
insertion rod 524 of a stylet disposed in the central lumen 522 and
a connector wire disposed in each peripheral lumen, such as
connector wire 526 disposed in the peripheral lumen 514. FIG. 5D is
a schematic transverse cross-sectional view of one embodiment of
the proximal end 504 of the lead 408. The proximal end 504 of the
lead 408 defines the central lumen 522 and the peripheral lumens
514-521 disposed laterally from the central lumen 522.
[0058] In at least some embodiments, the shape of the distal end of
the lead 408, as well as the positioning of the one or more
electrodes on the distal end of the lead 408 and the selected
de-activation of one or more particular electrodes, may affect one
or more variables of signals emitted from the electrodes, such as
the direction of the signal emission, or the strength of the signal
emission.
[0059] Changing the variables of the signals emitted from the
electrodes, such as the direction of the signal emission or the
strength of the signal emission may, in turn, affect the size and
shape of a stimulation region. FIG. 6A is a schematic transverse
cross-sectional view of one embodiment of the distal end 502 of the
lead 408. The lead 408 includes the arms 506-509. The lead 408 is
positioned in an area divided into regions 602-605 based, at least
in part, on the shape of the distal end 502 of the lead 408. For
example, in FIG. 6A, "Region A" 602, "Region B" 603, "Region C"
604, and "Region D" 605 are defined along perpendicular axes 606
and 608 extending along the arms 506 and 508 of the distal end 502
of the lead 408.
[0060] The electrodes can be positioned anywhere along any of the
arms 506-509. For example, in FIG. 6A the arm 506 includes the
electrode 610, the arm 507 includes the electrode 611, the arm 508
includes two electrodes 612 and 613, and the arm 508 does not
include any electrodes. In FIG. 6A, the electrodes 610-613 are
positioned so that two of the electrodes 610 and 612 are facing
"Region A" 602 and two of the electrodes 611 and 613 are facing
"Region B" 603, while no electrodes are facing either "Region C"
604 or "Region D" 605.
[0061] In FIG. 6A, the regions 602 and 603 each contain a target
structure 614 and 615, respectively, and the regions 604 and 605
each contain a non-target structure 616 and 617, respectively. In
at least some embodiments, the distal end 502 of the lead 408 can
be positioned so that target structures 614 and 615 are located in
proximity to the portions of the lead 408 containing electrodes.
Accordingly, in FIG. 6A, the target structures are located in
"Region A" 602 and "Region B" 603, but not in "Region C" 604 or
"Region D" 605. The "Region A" 602 and "Region B" 603 are
stimulation regions and "Region C" 604 and "Region D" 605 are
not.
[0062] In at least some embodiments, the electrodes 610-613 may
emit signals 618-621 in the stimulation regions, thereby
stimulating the target structures 614 and 615, without stimulating
the non-target structures 616 and 617. In alternate embodiments, a
similar emission pattern may be achieved by de-activation of
selected electrodes. For example, in at least some embodiments,
each of the arms 506-509 may include one or more electrodes and the
electrodes facing "Region C" 604 and "Region D" 605 may be
de-activated.
[0063] In alternate embodiments, the electrodes 610-613 may be
disposed at other locations along the arms 506-509 in order to
stimulate target structures in other regions. For example, in FIG.
6B, the target structures 615 and 617 are located in "Region B" 603
and "Region D" 605. Thus, the electrodes 610-613 can be positioned
so that "Region B" 603 and "Region D" 605 are the stimulation
regions, while the other regions are not. Hence, target structures
615 and 617 can be stimulated without stimulating the non-target
structures 614 and 616. In other alternate embodiments, two or more
electrodes may be positioned to provide stimulation in any one or
more of the regions 602-605, while not providing stimulation in the
remaining regions 602-605. In at least some embodiments, when more
than one region 602-605 is being stimulated, different stimulation
parameters can be applied to each stimulation region. For example,
in FIG. 6B a first current can be applied to the target structure
615 in "Region B" 603, while a second current that is different
from the first current can be applied to the target structure 617
in "Region D" 605. It will be understood that a similar emission
pattern may be achieved by disposing electrodes in each of the
regions and selectively de-activating one or more of the electrodes
in one or more non-selected regions.
[0064] FIG. 7A is a schematic transverse cross-sectional view of
one embodiment of a distal end of the lead 415. The lead 415 has an
L-shaped distal end that includes arms 702 and 704. The lead 415
also includes electrodes 706 and 707 disposed on opposite sides of
the arm 702, and electrodes 708 and 709 disposed on opposite sides
of the arm 704. The lead 415 is positioned in an area divided into
regions "Region A" 710 and "Region B" 712 based, at least in part,
on the shape of the distal end of the lead 415, the positioning of
the one or more electrodes 706-709, and the activation of one or
more of the electrodes 706-709. The "Region A" 710 includes target
structures 714, while the "Region B" 712 does not include any
target structure 714. Thus, "Region A" 710 is the stimulation
region. The electrodes 706 and 708 are positioned to face "Region
A" 710 and the electrodes 707 and 709 are positioned to face
"Region B" 712. As shown in FIG. 7A, the electrodes 706 and 708 are
emitting signals and the electrodes 707 and 709 are de-activated.
As a result, target structures 714 in "Region A" 710 are being
stimulated, while non-target structures in "Region B" 712 are not
being stimulated. In an alternate embodiment, the electrodes 707
and 709 emit signals while the electrodes 706 and 708 are
de-activated, as shown in FIG. 7B. Thus, in the alternate
embodiment "Region B" 712 is the stimulation region and,
accordingly, target structures in "Region B" 712 are being
stimulated and non-target structures in "Region B" 708 are not
being stimulated.
[0065] In at least some embodiments, providing electrodes of
various sizes and shapes may affect one or more variables of
signals emitted from the electrodes, such as the direction of the
signal emission, or the strength of the signal emission. Changing
the variables of the signals emitted from the electrodes, such as
the direction of the signal emission or the strength of the signal
emission may, in turn, affect the size and shape of a stimulation
region. In at least some embodiments one or more electrodes are
disposed on a single face of a distal end of a lead with a
multi-faced transverse cross-sectional shape. In at least some
embodiments, one or more electrodes are disposed on multiple faces
of a distal end of a lead with a multi-faced transverse
cross-sectional shape. In at least some embodiments, the directions
of signal emissions from an electrode disposed on a single face may
be different from the directions of signal emission from an
electrode disposed on multiple-faces. Additionally, in at least
some embodiments, a first electrode with a surface area that is
greater than the surface area of a second electrode may produce a
signal that travels a shorter distance than the second
electrode.
[0066] FIG. 8 is a schematic perspective view of one embodiment of
the lead 407 with a triangular transverse cross-sectional shape.
The lead 407 includes a distal end with a triangular transverse
cross-sectional shape that includes faces 802 and 804. The face 802
includes two differently-sized electrodes 806 and 808 disposed
solely on the face 802. The face 804 also includes two
differently-sized electrodes 810 and 812 disposed solely on the
face 804 and that are approximately the same shapes, sizes, and
relative locations as the electrodes 806 and 808 on the face 802.
Additionally, an electrode 814 is disposed on both the faces 802
and 804. In at least some embodiments, the electrode 814 extends
completely around a lateral circumference of the lead 407. In other
embodiments, the electrode 814 is only disposed on two faces of the
lead 407.
[0067] FIG. 9 is a schematic perspective view of one embodiment of
the lead 402 with a rectangular transverse cross-sectional shape.
The lead 402 includes a distal end with a rectangular transverse
cross-sectional shape that includes faces 902 and 904. The face 902
includes an electrode 906 disposed on the face 902. Likewise, the
face 904 includes an electrode 908 disposed on the face 904 that is
approximately the same size, shape, and relative positioning as the
electrode 906 disposed on the face 902. Additionally, an electrode
906 is disposed on both the face 902 and the face 904. Also,
electrodes 912 and 914 extend completely around a lateral
circumference of the lead 402. In other embodiments, the electrodes
912 and 914 are only disposed on two or tree faces of the lead
402.
[0068] In at least some embodiments, target structures that are
smaller in size than a diameter of a lead, such as one or more
neurons, may be stimulated using a lead that includes a hollow
interior region defined in a distal end of the lead. In some
embodiments, the distal end may have a circular transverse
cross-sectional shape. In other embodiments, the distal end may
have a non-circular transverse cross-sectional shape. For example,
a distal end may have a transverse cross-sectional shape that is
triangular, rectangular, star-shaped, cruciform-shaped, pentagonal,
hexagonal, and the like. FIG. 10A is a schematic perspective view
of one embodiment of the lead 412 that includes a distal end with a
circular transverse cross-sectional shape. The distal end of the
lead 412 includes an inner surface 1002 and an outer surface 1004.
Additionally, the distal end of the lead 412 defines a hollow
interior region 1006.
[0069] In at least some embodiments, the inner surface 1002 of the
distal end of the lead 412 includes at least one electrode, such as
electrode 1008. Thus, the lead 412 can be positioned so that one or
more target structures are disposed within the hollow interior
region 1006 of the distal end of the lead 412. In at least some
embodiments, when one or more target structures are disposed within
the hollow interior region 1006 of the distal end of the lead 412,
the hollow interior region 1006 is the stimulation region and one
or more target structures may be stimulated by the electrodes
disposed on the interior surface 1002 without stimulating
non-target structures located in a region exterior to the lead
412.
[0070] In at least some embodiments, one or more electrodes are
disposed on the outer surface 1004 of the lead 412. Thus, the lead
412 can be positioned so that one or more non-target structures are
disposed within the hollow interior region 1006 of the distal end
of the lead 412. In at least some embodiments, when one or more
non-target structures are disposed within the hollow interior
region 1006 of the distal end of the lead 412, the interior surface
1002 may either include no electrodes or include one or more
electrodes that are de-activated so that the one or more non-target
structures may be protected from stimulation while one or more
target structures located in the region exterior to the lead 412
(the stimulation region) are stimulated.
[0071] In FIG. 10A, eight electrodes are shown arranged linearly in
two matching patterns of four electrodes each disposed on opposite
sides of the inner surface 1002. The number of electrodes disposed
on the inner surface 1002 of the lead 412 may vary. For example,
there can be two, four, six, eight, ten, twelve, fourteen, sixteen,
or more electrodes. As will be recognized, other numbers of
electrodes may also be used. The number of electrodes disposed into
patterns on the inner surface 1002 of the lead 412 may also vary.
The types of patterns into which electrodes are disposed may also
vary. For example, there may be one or more linear patterns,
staggered patterns, zigzag patterns, or the like or combinations
thereof. Additionally, in at least some embodiments, the electrodes
can be arranged, at least in part, in a non-repeating pattern, or a
random pattern.
[0072] In at least some embodiments, one or more electrodes are
disposed on both the inner surface 1002 of the lead 412 and the
outer surface 1004 of the lead 412. In at least some embodiments,
the electrodes are disposed into patterns on the inner surface 1002
match the electrode patterns disposed on the outer surface 1004. In
FIG. 10B, eight electrodes are arranged linearly in two matching
patterns of four electrodes each. One of the two linearly-arranged
patterns is disposed on the inner surface 1002 and includes the
electrode 1008. The other of the two linearly-arranged patterns is
disposed on the opposite side of the outer surface 1004 and
includes the electrode 1010. FIG. 10C is a schematic perspective
view of another embodiment of the lead 412. The lead 412 includes
electrodes disposed on the inner surface 1002 in a zigzag pattern.
The lead 412 also includes electrodes disposed on an opposite side
of the lead 412 on the outer surface 1004 in a matching zigzag
pattern.
[0073] In at least some embodiments, the patterns electrodes are
disposed into on the inner surface 1002 do not match the patterns
electrodes are disposed into on the outer surface 1004. FIG. 10D is
a schematic perspective view of one embodiment of the lead 412. The
lead 412 includes electrodes disposed on the inner surface 1002 in
a linearly-arranged pattern and electrodes disposed on the outer
surface 1004 in a zigzag pattern. In some embodiments, each of the
electrodes disposed on the inner surface 1002 is disposed directly
medial to an electrode disposed on the outer surface 1004. In other
embodiments, at least one electrode disposed on the inner surface
1002 is not disposed directly medial to an electrode disposed on
the outer surface 1004.
[0074] Sometimes, a target structure can be more easily placed
within a hollow interior region when the distal end of the lead has
a C-shaped transverse cross-sectional shape instead of a circular
transverse cross-sectional shape. FIG. 11A is a schematic
perspective view of one embodiment of the lead 413. The lead 413
has a C-shaped transverse cross-sectional shape and includes an
inner surface 1102 and an outer surface 1104. The lead 413 also
includes a hollow interior region 1106 and a slit 1108 defined
along at least a portion of a longitudinal length of the distal end
of the lead 413. In at least some embodiments, the inner surface
1102 of the lead 413 includes at least one electrode, such as
electrode 1110.
[0075] In at least some embodiments, one or more electrodes can be
disposed on the lead 413 in a similar manner as the lead 412. In at
least some embodiments, the lead 413 can be positioned so that one
or more target structures, such as one or more neurons, are
disposed within the hollow interior region 1106 of the distal end
of the lead 413. In some embodiments, at least a portion of one or
more target structures may extend through the slit 1108. In at
least some embodiments, when one or more target structures are
disposed in the hollow interior region 1106 of the distal end of
the lead 413, the one or more target structures may be stimulated
by the electrodes disposed on the interior surface 1102 without
stimulating non-target structures located in a region exterior to
the lead 413.
[0076] In at least some embodiments, one or more electrodes are
disposed on the outer surface 1104 of the lead 413. Thus, the lead
413 can be positioned so that one or more non-target structures,
such as one or more neurons, are disposed within the hollow
interior region 1106 of the distal end of the lead 413. In at least
some embodiments, when one or more non-target structures are
disposed within the hollow interior region 1106 of the distal end
of the lead 413, the interior surface 1102 may either include no
electrodes or include one or more electrodes that are de-activated
so that the one or more non-target structures may be protected from
stimulation while one or more target structures located in the
region exterior to the lead 413 are stimulated.
[0077] In FIG. 11A, eight electrodes are shown arranged linearly in
two matching patterns of four electrodes each disposed on opposite
sides of the inner surface 1102. The number of electrodes disposed
on the inner surface 1102 of the lead 413 may vary. For example,
there can be two, four, six, eight, ten, twelve, fourteen, sixteen,
or more electrodes. As will be recognized, other numbers of
electrodes may also be used. The number of electrode patterns
disposed on the inner surface 1102 of the lead 413 may also vary.
The types of electrode patterns may also vary. For example, there
may be one or more linear patterns, staggered patterns, zigzag
patterns, or the like or combinations thereof. Additionally, in at
least some embodiments, the electrodes can be arranged, at least in
part, in a non-repeating pattern, or a random pattern.
[0078] In at least some embodiments, one or more electrodes are
disposed on both the inner surface 1102 of the lead 413 and the
outer surface 1104 of the lead 413. In at least some embodiments,
the electrodes are disposed into patterns on the inner surface 1102
that match the electrode patterns disposed on the outer surface
1104. In FIG. 11B, eight electrodes are arranged linearly in two
matching patterns of four electrodes each. One of the two
linearly-arranged patterns is disposed on the inner surface 1102
and includes the electrode 1110. The other of the two
linearly-arranged patterns is disposed on the opposite side of the
outer surface 1104 and includes the electrode 1012.
[0079] In at least some embodiments, the electrode patterns
disposed on the inner surface 1102 do not match the electrode
patterns disposed on the outer surface 1104. FIG. 11C is a
schematic perspective view of one embodiment of the lead 413. The
lead 413 includes electrodes disposed into a first staggered
pattern on the inner surface 1102 and electrodes disposed into a
second staggered pattern on the outer surface 1104. In some
embodiments, each of the electrodes disposed on the inner surface
1102 is disposed directly medial to an electrode disposed on the
outer surface 1104. In other embodiments, at least one electrode
disposed on the inner surface 1102 is not disposed directly medial
to an electrode disposed on the outer surface 1104.
[0080] FIG. 12 is a schematic overview of one embodiment of
components of an electrical stimulation system 1200 including an
electronic subassembly 1210 disposed within a control module. It
will be understood that the electrical stimulation system 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.
[0081] Some of the components (for example, power source 1212,
antenna 1218, receiver 1202, and processor 1204) of the electrical
stimulation system can be positioned on one or more circuit boards
or similar carriers within a sealed housing of an implantable pulse
generator, if desired. Any power source 1212 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.
[0082] As another alternative, power can be supplied by an external
power source through inductive coupling via the optional antenna
1218 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 user on a permanent or periodic basis.
[0083] If the power source 1212 is a rechargeable battery, the
battery may be recharged using the optional antenna 1218, if
desired. Power can be provided to the battery for recharging by
inductively coupling the battery through the antenna to a
recharging unit 1216 external to the user. Examples of such
arrangements can be found in the references identified above.
[0084] In one embodiment, electrical current is emitted by the
electrodes 134 on the paddle or lead body to stimulate nerve
fibers, muscle fibers, or other body tissues near the electrical
stimulation system. A processor 1204 is generally included to
control the timing and electrical characteristics of the electrical
stimulation system. For example, the processor 1204 can, if
desired, control one or more of the timing, frequency, strength,
duration, and waveform of the pulses. In addition, the processor
1204 can select which electrodes can be used to provide
stimulation, if desired. In some embodiments, the processor 1204
may select which electrodes) are cathodes and which electrode(s)
are anodes. In some embodiments, the processor 1204 may be used to
identify which electrodes provide the most useful stimulation of
the desired tissue.
[0085] Any processor can be used and can be as simple as an
electronic device that, for example, produces pulses at a regular
interval or the processor can be capable of receiving and
interpreting instructions from an external programming unit 1208
that, for example, allows modification of pulse characteristics. In
the illustrated embodiment, the processor 1204 is coupled to a
receiver 1202 which, in turn, is coupled to the optional antenna
1218. This allows the processor 1204 to receive instructions from
an external source to, for example, direct the pulse
characteristics and the selection of electrodes, if desired.
[0086] In one embodiment, the antenna 1218 is capable of receiving
signals (e.g., RF signals) from an external telemetry unit 1206
which is programmed by a programming unit 1208. The programming
unit 1208 can be external to, or part of, the telemetry unit 1206.
The telemetry unit 1206 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, cellular phone, or remote control, if desired. As
another alternative, the telemetry unit 1206 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 1208 can be any unit
that can provide information to the telemetry unit 1206 for
transmission to the electrical stimulation system 1200. The
programming unit 1208 can be part of the telemetry unit 1206 or can
provide signals or information to the telemetry unit 1206 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 1206.
[0087] The signals sent to the processor 1204 via the antenna 1218
and receiver 1202 can be used to modify or otherwise direct the
operation of the electrical stimulation system. For example, the
signals may be used to modify the pulses of the electrical
stimulation system such as modifying one or more of pulse duration,
pulse frequency, pulse waveform, and pulse strength. The signals
may also direct the electrical stimulation system 1200 to cease
operation, to start operation, to start charging the battery, or to
stop charging the battery. In other embodiments, the stimulation
system does not include an antenna 1218 or receiver 1202 and the
processor 1204 operates as programmed.
[0088] Optionally, the electrical stimulation system 1200 may
include a transmitter (not shown) coupled to the processor 1204 and
the antenna 1218 for transmitting signals back to the telemetry
unit 1206 or another unit capable of receiving the signals. For
example, the electrical stimulation system 1200 may transmit
signals indicating whether the electrical stimulation system 1200
is operating properly or not or indicating when the battery needs
to be charged or the level of charge remaining in the battery. The
processor 1204 may also be capable of transmitting information
about the pulse characteristics so that a user or clinician can
determine or verify the characteristics.
[0089] 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.
* * * * *